(A) A general
license is hereby issued to commercial and industrial firms; research,
educational, and medical institutions; individuals in the conduct of their
business; and state or local government agencies to acquire, receive, possess,
use or transfer, in accordance with the provisions of paragraphs (B) to (D) of
this rule, radioactive material contained in devices designed and manufactured
for the purpose of detecting, measuring, gauging or controlling thickness,
density, level, interface location, radiation, leakage, or qualitative or
quantitative chemical composition, or for producing light or an ionized
atmosphere.
(B)
(1) The general license in paragraph (A) of
this rule applies only to radioactive material contained in devices which have
been manufactured or initially transferred and labeled in accordance with the
specifications contained in:
(a) A specific
license issued under rule
3701:1-46-30
of the Administrative Code;
(b) An
equivalent specific license issued by an agreement state; or
(c) An equivalent specific license issued by
the United States nuclear regulatory commission.
(2) The devices must have been received from
one of the specific licensees described in paragraph (B)(1) of this rule or
through a transfer made under paragraph (C)(9) of this rule.
(C) Any person who acquires,
receives, possesses, uses or transfers radioactive material in a device
pursuant to the general license in paragraph (A) of this rule:
(1) Shall assure that all labels affixed to
the device at the time of receipt and bearing a statement that removal of the
label is prohibited are maintained thereon and shall comply with all
instructions and precautions provided by such labels;
(2) Shall assure that the device is tested
for leakage of radioactive material and proper operation of the on-off
mechanism and indicator, if any, at no longer than six-month intervals or at
such other intervals as are specified in the label; however:
(a) Devices containing only krypton need not
be tested for leakage of radioactive material, and
(b) Devices containing only tritium or not
more than 3.7 megabecquerels (one hundred microcuries) of other beta and/or
gamma emitting material or three hundred seventy kilobecquerels (ten
microcuries) of alpha emitting material and devices held in storage in the
original shipping container prior to initial installation need not be tested
for any purpose;
(3)
Shall assure that the tests required by paragraph (C)(2) of this rule and other
testing, installation, servicing, and removal from installation involving the
radioactive materials, its shielding or containment, are performed:
(a) In accordance with the instructions
provided by the labels; or
(b) By
a person holding a specific license pursuant to this chapter and Chapter
3701:1-40 of the Administrative Code or from an agreement state or the United
States nuclear regulatory commission to perform such activities;
(4) Shall maintain records showing
compliance with the requirements of paragraphs (C)(2) and (C)(3) of this rule.
The records must show the results of tests. The records also must show the
dates of performance of, and the names of persons performing, testing,
installing, servicing, and removing from the installation radioactive material
and its shielding or containment. The licensee shall retain these records as
follows:
(a) Each record of a test for
leakage or radioactive material required by paragraph (C)(2) of this rule must
be retained for three years after the next required leak test is performed or
until the sealed source is transferred or disposed of.
(b) Each record of a test of the on-off
mechanism and indicator required by paragraph (C)(2) of this rule must be
retained for three years after the next required test of the on-off mechanism
and indicator is performed or until the sealed source is transferred or
disposed of.
(c) Each record that
is required by paragraph (C)(3) of this rule must be retained for three years
from the date of the recorded event or until the device is transferred or
disposed of.
(5) Shall
immediately suspend operation of the device if there is a failure of, or damage
to, or any indication of a possible failure of or damage to, the shielding of
the radioactive material or the on-off mechanism or indicator, or upon the
detection of one hundred eighty-five becquerels ( 0.005 microcurie) or more
removable radioactive material. The device may not be operated until it has
been repaired by the manufacturer or other person holding a specific license to
repair such devices that was issued under Chapters 3701:1-40 and 3701:1-46 of
the Administrative Code or by an agreement state or the United States nuclear
regulatory commission. The device and any radioactive material from the device
may only be disposed of by transfer to a person authorized by a specific
license to receive the radioactive material in the device or as otherwise
approved by the director. A report containing a brief description of the event
and the remedial action taken; and, in the case of detection of one hundred
eighty-five becquerels ( 0.005 microcurie) or more removable radioactive
material or failure of or damage to a source likely to result in contamination
of the premises or the environs, a plan for ensuring that the premises and
environs are acceptable for unrestricted use, must be furnished to the director
within thirty days.
(6) Shall not
abandon the device containing radioactive material;
(7) Shall not export the device containing
radioactive material except in accordance with applicable United States nuclear
regulatory commission regulations;
(8)
(a)
Shall transfer or dispose of the device containing radioactive material only by
export as provided by paragraph (C)(7) of this rule, by transfer to another
general licensee as authorized in paragraph (C)(9) of this rule, or to a person
authorized to receive the device by a specific license issued under this
chapter and Chapter 3701:1-40 of the Administrative Code, utilizing a licensed
broker or other authorized waste collector, or equivalent regulations of an
agreement state, United States nuclear regulatory commission, or as approved
under paragraph (C)(8)(c) of this rule.
(b) Shall within thirty days after the
transfer of a device to a specific licensee or export, furnish a report to the
director by an appropriate method listed in rule
3701:1-40-04 of
the Administrative Code, The report must contain:
(i) The identification of the device by
manufacturer's (or initial transferor's) name, model number, and serial number;
(ii) The name, address, and
license number of the person receiving the device; and
(iii) The date of the transfer.
(c) Shall obtain written director
approval before transferring the device to any other specific licensee not
specifically identified in paragraph (C)(8)(a) of this rule; however, a holder
of a specific license may transfer a device for possession and use under its
own specific license without prior approval, if the holder:
(i) Verifies that the specific license
authorizes the possession and use, or applies for and obtains an amendment to
the license authorizing the possession and use;
(ii) Removes, alters, covers, or clearly and
unambiguously augments the existing label (otherwise required by paragraph
(C)(1) of this rule) so that the device is labeled in compliance with rule
3701:1-38-18
of the Administrative Code; however the manufacturer, model number, and serial
number must be retained;
(iii)
Obtains the manufacturer's or initial transferor's information concerning
maintenance that would be applicable under the specific license (such as leak
testing procedures); and
(iv)
Reports the transfer under paragraph (C)(8)(b) of this rule.
(9) Shall transfer the
device to another general licensee only if:
(a) The device remains in use at a particular
location. In this case, the transferor shall give the transferee a copy of this
rule and any safety documents identified in the label of the device. Within
thirty days of the transfer, the transferor shall report to the
director:
(i) The
manufacturer's (or initial transferor's) name;
(ii) The model number and the serial number
of the device transferred;
(iii)
The transferee's name and mailing address for the location of use; and
(iv) The name, title, and phone
number of the responsible individual identified by the transferee in accordance
with paragraph (C)(12) of this rule to have knowledge of and authority to take
actions to ensure compliance with the appropriate rules and requirements; or
(b) The device is held
in storage by an intermediate person in the original shipping container at its
intended location of use prior to initial use by a general licensee.
(10) Shall comply with the
provisions of paragraphs (A) and (B) of rule
3701:1-38-21 of the
Administrative Code for reporting radiation incidents, theft or loss of
licensed material, but shall be exempt from the other requirements of Chapter
3701:1-38 of the Administrative Code.
(11) Shall respond to written requests from
the director to provide information relating to the general license within
thirty calendar days of the date of the request, or other time specified in the
request. If the general licensee cannot provide the requested information
within the allotted time, it shall, within that same time period, request a
longer period to supply the information by providing the director, by an
appropriate method listed in rule
3701:1-40-04 of
the Administrative Code, a written justification for the request.
(12) Shall appoint an individual responsible
for having knowledge of the appropriate rules and requirements and the
authority for taking required actions to comply with appropriate rules and
requirements. The general licensee, through this individual, shall ensure the
day-to-day compliance with appropriate rules and requirements. This appointment
does not relieve the general licensee of responsibility in this regard.
(13)
(a) Shall report, in accordance with
paragraphs (C)(13)(b) and (C)(13)(c) of this rule, devices containing at least
three hundred seventy megabecquerels (ten millicuries) of cesium-137, 3.7
megabecquerels ( 0.1 millicurie) of strontium-90, thirty-seven megabecquerels
(one millicurie) of cobalt-60, 3.7 megabecquerels ( 0.1 millicurie) of radium,
or thirty-seven megabecquerels (one millicurie) of americium-241 or any other
transuranic, i.e., element with atomic number greater than uranium (92), based
on the activity indicated on the label. Each address for a location of use, as
described under paragraph (C)(13)(c)(iv) of this rule, represents a separate
general license and requires a separate registration and fee.
(b) If in possession of a device meeting the
criteria of paragraph (C)(13)(a) of this rule, shall report these devices
annually to the director and shall pay the fee required by paragraph (S) of
rule
3701:1-38-02
of the Administrative Code. Reporting must be done by verifying, correcting,
and/or adding to the information provided in a request received from the
director. The information must be submitted to the director within thirty days
of the date of the request for information or as otherwise indicated in the
request. In addition, a general licensee holding devices meeting the criteria
of paragraph (C)(13)(a) of this rule is subject to the bankruptcy notification
requirement in Chapter 3701:1-40 of the Administrative Code.
(c) In reporting the devices, the general
licensee shall furnish the following information and any other information
specifically requested by the director:
(i)
Name and mailing address of the general licensee;
(ii) Information about each device: the
manufacturer (or initial transferor), model number, serial number, the
radionuclide and activity (as indicated on the label);
(iii) Name, title, and telephone number of
the responsible person designated as a representative of the general licensee
under paragraph (C)(12) of this rule;
(iv)
Address or location at which the device(s) are used and/or stored;
(v) Certification by the responsible
representative of the general licensee that the information concerning the
device(s) has been verified through a physical inventory and checking of label
information;
and
(vi) Certification by
the responsible representative of the general licensee that they are aware of
the requirements of the general license.
(14) Shall report changes to the mailing
address for the location of use (including change in name of general licensee)
to the director within thirty days of the effective date of the change.
(15) May not hold devices that are
not in use for longer than two years. If devices with shutters are not being
used, the shutter must be locked in the closed position. The testing required
by paragraph (C)(2) of this rule need not be performed during the period of
storage only. However, when devices are put back into service or transferred to
another person, and have not been tested within the required test interval,
they must be tested for leakage before use or transfer and the shutter tested
before use. Devices kept in standby for future use are excluded from the two
year time limit if the general licensee performs quarterly physical inventories
of these devices while they are in standby.
(D) The director may order the inspection of
any facility licensed under this rule if the director determines that an
appropriate reason for the inspection exists. These inspections shall be
considered as full cost inspections as defined in rule
3701:1-38-02
of the Administrative Code. The reasons the director may conduct for cause
inspections include, but are not limited to;
(1) Failure to respond to official
correspondence;
(2)
Release of radioactive material to the environment;
(3) Investigations of alleged violations of
department rules; or
(4)
Failure to comply with the license application process.
(E) The general license in paragraph (A) of
this rule does not authorize the manufacture or import of devices containing
radioactive material.