DRC-2024-004670

2
Training

Only persons authorized by the Berthold Radiation Safety Officer (RSO) may perform the training of
users (customers) of GL devices. The Customer shall nominate employees to be trained and a contact
person for future interactions. The contact person shall be one of the trainees. All training shall be
documented.

Training will consist of but is not limited to the following categories;

1. Introduction & Fundamentals of Radiation Safety
2. General License Requirements/Regulations
3. Periodic Device Testing for Radioactive Leakage and Proper Operation
4. What to do if there is a problem such as Theft, Loss, or a Fire
5. Record Retention
6. Repair, Maintenance, Limitations of Transfer or Movement, Disposal, and Shipping
7. Commissioning, Calibration, and Operation
8. Reportable Events & Emergency Procedures

GUIDE FOR RECEIPT
AND MOUNTING OF DEVICES
This device is registered with the State of Tennessee. You are therefore subject
to the requirements of SPAR 0400-20-10.10(2), the equivalent NRC or
Agreement State regulations. A copy of this section of the SRPAR is included
with this enclosure.
If you are operating under a General License, these regulations will be reviewed
as part of the commissioning training lecture. Excerpts of the regulations and
specific guidelines for mounting the device prior to commissioning are
highlighted below. Before proceeding, please review the Radiation Safety Guide
enclosed with the Operator's Manual and observe the principles described. In
general, always observe the following: (a) Keep the time of hand-contact (body
contact) with the device as short as possible. This can be achieved by planning
the mounting process and having all necessary parts and tools ready before
starting to mount the device. (b) Maximize the distance between you and the
device at all times.
1)When you receive the device, you must p erform a visual inspection for
damage and ensure that the device is in the closed locked position and
that the transport seals are intact. If damage is evident or suspected,
prevent access to the vicinity of the device and contact Berthold
immediately at 865-483-1488 and ask for the Radiation Safety Officer.
2)If the device is undamaged, you may proceed to mount the device to
the process location. The device may only be mounted in a location
compatible with the "Conditions of Normal Use" on the registration
certificate and as described in the Operation Manual. Berthold will
have sanctioned the mounting location prior to shipment of the device
to your location. The device must remain in the sealed and locked
closed condition at all times during the mounting process and may
ONLY be unlocked (prior to commissioning) in the presence of a
person specifically li censed by the NRC or an Agreement State.

3) Normal and general safety precautions must be used when mounting
the device, consistent with the size, shape and weight of the device and
the process location.

4) The device may not be modified in any way or at any time.

5) You may not remove or service the device (source or shielding)
without our assistance, or the assistance of another service organization
specifically licensed by the NRC or an Agreement State .

6) You are to ensure that all labels and instructions affixed to the device are
not removed and that the labels are maintained in legible condition.

7) You are to ensure that leak tests and shutter tests indicated on the labels
are performed at appropriate intervals and you are to maintain records of
all tests and services performed on the device.

8) You are required to maintain records of receipt and copies of each Source
Certificate, radiation survey data upon installation , and serial numbers of
the source and shielding.

9) Never abandon the device. It contains radioactive material.

10) Berthold personnel or other persons specifically licensed by the NRC or
an agreement State must accomplish removal, disposal and replacement
of sources.

11) Refer to the attached SRPAR 0400-20-10.10(2) 8 & 9, regarding transfer
of the device.

12) In case of accident, such as fire, immediately obtain professional radiation
safety assistance from Berthold or other persons specifically licensed by
the NRC or an Agreement State. In case of theft or loss of radioactive
material, you must notify the Nuclear Regulatory Commission or your
state licensing authority if you are in an Agreement State. For assistance
from Berthold, telephone [phone] and ask for the RSO.
13)Any questions regarding safety and compliance should be addressed to:
Berthold Technologies
99 Midway Lane
Oak Ridge, TN 37830
865-483-1488
[e-mail]
General License Regulations-State of Tennessee
June 2015 (Revised)
0400-20-10-.10 GENERAL LICENSES (6) - RADIOACTIVE MATERIAL OTHER THAN
SOURCE MATERIAL.
(1)A general license is hereby issued to receive, acquire, own, possess, use and transfer
radioactive material incorporated into a device or equipment which is listed in Schedule RHS 8-5 and has
been manufactured pursuant to a specific license or equivalent licensing document, issued by the
Division, the U.S. Nuclear Regulatory Commission, or any Agreement State and authorizing distribution
under the general license of this paragraph or its equivalent. The use of a Generally Licensed device is
regulated by the U.S. Nuclear Regulatory Commission or an Agreement State under requirements
substantially the same as those outlined is 0400-20-10.10(2).
(2)Certain detecting, measuring, gauging or controlling devices and certain devices for producing light or
an ionized atmosphere. (7)
(6)Different general licenses are issued in this rule, each of which has its own specific conditions and requirements.
(7)Persons possessing radioactive material in devices under the general license in this paragraph before October 2, 1978, may
continue to possess, use or transfer that material in accordance with the requirements in the 1972 edition of the regulations
(a)A general license is hereby issued to commercial and industrial firms and research,
educational and medical institutions, individuals in the conduct of their business and State
or local government agencies to own, acquire, receive, possess, use or transfer, in
accordance with the provisions of subparagraphs (b), (c) and (d) of this paragraph,
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 subparagraph (a) of this paragraph applies only to
radioactive material contained in devices that have been manufactured or initially
transferred and labeled in accordance with the specifications contained in:
(i) A specific license issued by the Division pursuant to paragraph (5) of Rule
0400-20-10-.13, or
(ii) A specific license issued by the U.S. Nuclear Regulatory Commission
pursuant to 10 CFR 32.51 or an Agreement State with provisions that are
comparable to paragraph (5) of Rule 0400-20-10-.13.
2. The devices shall have been received from one of the licensees in part 1 of this
subparagraph or through a transfer made under part (c)9 of this paragraph.
(c)Persons who own, acquire, receive, possess, use or transfer radioactive material in a device
pursuant to the general license contained in subparagraph (a) of this paragraph:
1. Shall assure that all labels affixed to the device at the time of receipt and bearing
the 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
6 month intervals or at such other intervals as are specified in the label; however,
(i) Devices containing only krypton need not be tested for leakage of
radioactive material; and
(ii) Devices containing only tritium or not more than 100 microcuries of other
beta and/or gamma emitting material or 10 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 part 2 of this subparagraph and other
testing, installation, servicing and removal from installation involving the
radioactive material, its shielding or containment, are performed:
(i)In accordance with the instructions provided by the labels, or
(ii) By a person holding an applicable specific license issued by the Division,
the U.S. Nuclear Regulatory Commission, an Agreement State or a
Licensing State to perform such activities.
4. Shall maintain records showing compliance with the requirements of parts 2 and
3 of this subparagraph. The records shall show the results of tests. The records
also shall show the dates of performance of and the names of persons
performing testing, installation, servicing and removal from installation of the
radioactive material, its shielding or containment. The licensee shall retain these
records as follows:
(i) Each record of a test for leakage or radioactive material required by part
2 of this subparagraph shall be retained for 3 years after the next required
leak test is performed or until the sealed source is transferred or disposed
of;
(ii) Each record of a test of the on-off mechanism and indicator required by
part 2 of this subparagraph shall be retained for 3 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; and
(iii) Each record that is required by part 3 of this subparagraph shall be
retained for 3 years from the date of the recorded event or until the sealed
source 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 0.005 microcurie (185 Becquerel) or more removable radioactive
material. The device may not be operated until it has been repaired by the
manufacturer or another person holding an applicable specific license issued by the
Division, the U.S. Nuclear Regulatory Commission, an Agreement State or a
Licensing State to repair such devices. The device and any radioactive material
from the device may only be disposed of by transfer to a person holding an
applicable specific license to receive the radioactive material contained in the
device or as otherwise approved by the Division. The licensee shall within 30
days furnish to the Division at the address in Rule 0400-20-04-.07 a report
containing a brief description of the event and the remedial action taken. In the
case of detection of 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, the licensee shall within 30 days submit to the Division at the
address in Rule 0400-20-04-.07 a plan for ensuring that the premises and
environs are acceptable for unrestricted use. Under these circumstances, the
criteria set out in paragraph (2) of Rule 0400-20-10-.36, "Radiological criteria for
unrestricted use," may be applicable, as determined by the Division on a case by-
case basis;
6. Shall not abandon the device containing radioactive material;
7.Shall not export the device containing radioactive material except in accordance
with 10 CFR 110;
8. Shall:
(i) Transfer or dispose of the device containing radioactive material only by
export as provided by part 7 of this subparagraph, by transfer to another
general licensee as authorized in part 9 of this subparagraph, or to a
person authorized to receive the device by a specific license issued by the
Division under this Chapter or an equivalent license issued by the U.S.
Nuclear Regulatory Commission or an Agreement State, or as otherwise
approved under subpart (iii) of this part.
(ii) Shall within 30 days after the transfer of a device to a specific licensee or
export furnish a report to the Division. The report shall 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 (license number not applicable if exported); and
(III) The date of the transfer.
(iii) Shall obtain written Division approval before transferring the device to any
other specific licensee not specifically identified in subpart (i) of this part.
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 part 1 of this subparagraph)
so that the device is labeled in compliance with Rule 0400-20-05-
.113; however, the manufacturer, model number, and serial number
must be retained;
(III) Obtains 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 subpart (ii) of this part.
9. Shall transfer the device to another general licensee only if:
(i) The device remains in use at a particular location. In this case, the
transferor shall give the transferee a copy of this paragraph and any safety
documents identified in the label of the device. Within 30 days of the
transfer, the transferor shall report to the Division:
(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 part 12 of this
subparagraph to have knowledge of and authority to take actions to
ensure compliance with the appropriate regulations and requirements; or
(ii) 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 Rules 0400-20-05-.140 and 0400-20-05-.141
for reporting radiation incidents, theft or loss of radioactive material;
11.Shall respond to written requests from the Division to provide information relating
to the general license within 30 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 submitting a letter to
the Division at the address in Rule 0400-20-04-.07 providing written justification
as to why it cannot comply;
12.Shall appoint an individual responsible for having knowledge of the appropriate
regulations and requirements and the authority for taking required actions to
comply with appropriate regulations and requirements. The general licensee,
through this individual, shall ensure the day-to-day compliance with appropriate
regulations and requirements. This appointment does not relieve the general
licensee of any of its responsibility in this regard;
13. Shall:
(i) Report these devices to the Division annually. Reporting shall be done by
verifying, correcting and/or adding to the information provided in a request
for a report received from the Division. The report information shall be
submitted to the Division within 30 days of the date of the request or as
otherwise indicated in the request.
(ii) In reporting devices, furnish the following information and any other
information specifically requested by the Division:
(I)Name and mailing address of the general licensee;
(II) Information about each device: the manufacturer (or initial
transferor), model number, serial number, the radioisotope 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 part 12
of this subparagraph;
(IV) Address or location at which the device(s) are used and/or stored.
For portable devices, the address of the primary place of storage.
Each address for a location of use represents a separate general
license;
(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 be subject to the bankruptcy notification requirement in paragraph (7) of
Rule 0400-20-10-.16 if holding devices containing radioactive material that meet
the following criteria, based on the activity indicated on the label.
(i)At least 10 mCi (370MBq) of cesium-137;
(ii)At least 0.1 mCi (3.7 MBq) of strontium-90;
(iii)At least 1 mCi (37 MBq) of cobalt-60;
(iv) At least 1 mCi (37 MBq) of americium-241 or any other transuranic (i.e.
element with atomic number greater than uranium (92)); or
(v)At least 0.1 mCi (37 MBq) of radium-226.
15.Persons generally licensed by the U.S. Nuclear Regulatory Commission or an
Agreement State with respect to devices meeting the criteria in parts 13 and 14
of this subparagraph are not subject to reporting requirements if the devices are
used in areas subject to the Division’s jurisdiction for a period less than 180 days
in any calendar year. The Division will not request reporting information from
such licensees.
16.Shall report changes to the mailing address for the location of use (including
change in name of general licensee) to the Division, at the address in Rule 0400-
20-04-.07, within 30 days of the effective date of the change. For a portable
device, a report of address change is only required for a change in the device's
primary place of storage;
17.Shall not hold devices that are not in use for longer than 2 years. If devices with
shutters are not being used, the shutter shall be locked in the closed position.
The testing required by part 2 of this subparagraph 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 shall 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
2-year time limit if the general licensee performs quarterly physical inventories of
these devices while they are in storage.
(d) The general license provided in this paragraph is subject to the provisions of
paragraphs (1), (2) and (3) of Rule 0400-20-10.16, paragraphs (1), (2) and (3) of Rule
0400-20-10-.23, Rules 0400-20-10-.26 through 0400-20-10-.28 and Rule 0400-20-10-
.30.
(e) The general license in subparagraph (a) of this paragraph does not authorize the
manufacture or import of devices containing radioactive material.