Tenn. Comp. R. & Regs. 0400-20-10-.13 - SPECIAL REQUIREMENTS FOR ISSUANCE OF SPECIFIC LICENSES
(1)
Reserved.
(2) Reserved.
(3) An application for a specific license to
initially transfer source material for use under Rule
0400-20-10-.09,
or provisions equivalent to Rule
0400-20-10-.09,
will be approved if:
(a) The applicant
satisfies the general requirements specified in Rule
0400-20-10-.12;
and
(b) The applicant submits
adequate information on, and the Division approves, the methods to be used for
quality control, labeling, and providing safety instructions to
recipients.
(4) Multiple
quantities of types of radioactive material for use in research and
development. In addition to the requirements set forth in Rule
0400-20-10-.12,
a specific license for multiple quantities or types of radioactive material for
use in research and development will be issued only if :
(a) The applicant has established an isotope
committee (composed of such persons as a radiological safety officer, a
representative of the business office, and one or more persons trained or
experienced in the safe use of radioactive materials) which will review and
approve, in advance of purchase of radioisotopes, proposals for use;
and
(b) The applicant has appointed
a radiological safety officer who will advise and assist on radiological safety
problems.
(5)
Manufacture, distribution or initial distribution of devices to persons
generally licensed under paragraph (2) of Rule
0400-20-10-.10.
(a) In addition to the requirements set forth
in Rule
0400-20-10-.12,
a specific license to distribute certain devices of the types enumerated in
paragraph (2) of Rule 0400-20-10.10 to persons generally licensed under
paragraph (2) of Rule
0400-20-10-.10
or equivalent regulations of the U.S. Nuclear Regulatory Commission, an
Agreement State or a Licensing State will be issued only if:
1. The applicant submits sufficient
information relating to the design, manufacture, prototype testing, quality
control, labels, proposed uses, installation, servicing, leak testing,
operating and safety instructions, and potential hazards of the device to
provide assurance that:
(i) The device can be
safely operated by persons not having training in radiological
protection;
(ii) Under ordinary
conditions of handling, storage and use of the device, the radioactive material
contained in the device will not be released or inadvertently removed from the
device, and no person will receive in 1 year a dose in excess of 10 percent of
the limits specified in Rule 0400-20-05.50; and
(iii) Under accident conditions (such as fire
and explosion) associated with handling, storage and use of the device, it is
unlikely that any person would receive an external radiation dose or dose
commitment in excess of the dose to the appropriate organ as specified in Table
RHS 7-1:
TABLE RHS 7-1
TABLE OF ORGAN DOSES
|
Part of Body |
rem |
mSv/ Sv |
|
Whole body; head and trunk; active blood forming organs; gonads; or lens of eye |
15 |
150 mSv |
|
Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter |
200 |
2 Sv |
|
Other organs |
50 |
500 mSv |
2. Each device bears a durable, legible
clearly visible label or labels approved by the Division that contain(s) in a
clearly identified and separate statement:
(i)
Instructions and precautions for safe installation, operation and servicing of
the device (documents such as operating and service manuals may be identified
in the label and used to provide this information);
(ii) The requirements, or lack of
requirement, for leak testing, or for testing any on-off mechanism and
indicator, including the maximum time interval for such testing, and the
identification of the radioactive material by isotope, quantity of
radioactivity and date of determination of the quantity; and
(iii) The information called for in one of
the following statements in the same or similar form:
(I) The receipt, possession, use, and transfer of this device,
Model __________,10 Serial No.
__________,10 are subject to a general license or
the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or
of a State with which the NRC has entered into an agreement for the exercise of
regulatory authority. This label shall be maintained on the device in a legible
condition. Removal of this label is prohibited.
CAUTION - RADIOACTIVE MATERIAL
_____________________________________
(Name of manufacturer or distributor)
(II) The receipt, possession, use and
transfer of this device Model __________,10 Serial No.
__________,10 are subject to a general license or
the equivalent and the regulations of a Licensing State. This label shall be
maintained on the device in a legible condition. Removal of this label is
prohibited.
CAUTION - RADIOACTIVE MATERIAL
_____________________________________
(Name of manufacturer or distributor)
3. Each device having a separable
source housing that provides the primary shielding for the source also bears,
on the source housing, a durable label containing the device model number and
serial number, the isotope and quantity, the words "CAUTION - RADIOACTIVE
MATERIAL," and, if practicable, the radiation symbol described in Rule
0400-20-05-.110 and
the name of the manufacturer or initial distributor.
4. Each device meeting the criteria of Rule
0400-20-10-.10
bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed
to the source housing if separable, or the device if the source housing is not
separable, that includes the words, "CAUTION - RADIOACTIVE MATERIAL," and, if
practicable, the radiation symbol described in Rule
0400-20-05-.110.
5. The device has been registered in the
Sealed Source and Device Registry.
(b) In the event the applicant desires that
the device be tested at intervals longer than 6 months, either for proper
operation of the on-off mechanism and indicator, if any, or for leakage of
radioactive material, or for both, he shall include in his application
information to demonstrate that such longer interval is justified by
performance characteristics of the device or similar devices, and by design
features that have a significant bearing on the probability or consequences of
leakage of radioactive material or failure of the on-off mechanism indicator.
In determining the acceptable interval for the test for leakage of radioactive
material, the Division will consider information that includes, but is not
limited to:
1. Primary containment (source
capsule);
2. Protection of primary
containment;
3. Method of sealing
containment;
4. Containment
construction materials;
5. Form of
contained radioactive material;
6.
Maximum temperature withstood during prototype tests;
7. Maximum pressure withstood during
prototype tests;
8. Maximum
quantity of contained radioactive material;
9. Radiotoxicity of contained radioactive
material; and
10. Operating
experience with identical devices or similarly designed and constructed
devices;
(c) In the
event the applicant desires that the general licensee under paragraph (2) of
Rule
0400-20-10-.10
or under equivalent regulations of the U.S. Nuclear Regulatory Commission, an
Agreement State or a Licensing State, be authorized to install the device,
collect the sample to be analyzed by a specific licensee for leakage of
radioactive material, service the device, test the on-off mechanism and
indicator, or remove the device from installation, he shall include in his
application written instructions to be followed by the general licensee,
estimated calendar quarter doses associated with such activity or activities
and the basis for such estimates. The submitted information shall demonstrate
that performance of such activity or activities by an individual untrained in
radiological protection, in addition to other handling, storage and use of
devices under the general license, will not cause that individual to receive in
one year a dose in excess of 10 percent of the limits specified in Rule 0
40020-05-.50;
(d) Before
radioactive material may be transferred in a device for use under a general
license, each person licensed under this paragraph shall furnish the following
information to each person to whom he directly or through an intermediate
person transfers radioactive material in a device. In the case of a transfer
through an intermediate person, the information shall be provided to the
intended user and to the intermediate person prior to initial transfer to the
intermediate person.
|
For use under the general license contained in paragraph (2) of Rule 0 40020-10-.10 |
For use under equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State or a Licensing State |
|
1. A Copy of the general license contained in paragraph (2) of Rule 0400-20-10-.10. |
A copy of the general license contained in the U.S. Nuclear Regulatory Commission's, Agreement State's, or Licensing State's regulations equivalent to paragraph (2) Rule 0400-20-10-.10. |
|
Alternatively, he may furnish a copy of the general license contained in paragraph (2) of Rule 0400-20-10-.10. If a copy of the general license in paragraph (2) of Rule 0400-20-10-.10 is furnished to such a person, it shall be accompanied by a note explaining that the use of the device is regulated by the U.S. Nuclear Regulatory Commission, Agreement State or Licensing State under requirements substantially the same as those in paragraph (2) of Rule 0400-20-10-.10; |
|
|
If parts (2)(c)2 through 4 or 13 of Rule 0400-20-10-.10 do not apply to the particular device, those parts may be omitted; |
If parts (2)(c)2 through 4 or 13 of Rule 0400-20-10-.10, or sections of the Agreement State or Licensing State regulations equivalent to those parts, do not apply to the particular device, those parts may be omitted. |
|
2. A copy of Rules 0400-20-10-.26, 0400-20-05-.140 and 0400-2005-.141. |
A copy of 10 CFR §§ 31.2, 30.51, 20.2201, and 20.2202 or the Agreement State or Licensing State regulations equivalent to these NRC regulations. |
3. A list of
services that may only be performed by a specific licensee;
4. Information on acceptable disposal options
including estimated costs of disposal;
5. A statement that regulatory agencies may
issue citations and civil penalties for improper disposal; and
6. The name or title, address, and phone
number of the person at the appropriate regulatory agency from whom additional
information may be obtained.
(e) An alternative approach to informing
customers may be proposed by the licensee for approval by the
Division.
(f) Each device that is
transferred on May 26, 2008 or later shall meet the labeling requirements in
parts (a)2, 3, and 4 of this paragraph.
(g)
1. Each
person licensed under this paragraph to distribute devices to generally
licensed persons shall:
(i) Report to the
Division, at its offices located at the address in Rule 0400- 20 04-.07, all
transfers of such devices to persons for use under the general license in
paragraph (2) of Rule
0400-20-10-.10.
(ii) Report to the U.S. Nuclear Regulatory
Commission all transfers of such devices to persons for use under the U.S.
Nuclear Regulatory Commission general license in Section 31.5 of 10 CFR Part
31.
(iii) Report to the responsible
Agreement or Licensing State agency all transfers of devices manufactured and
distributed pursuant to this paragraph for use under a general license in that
state's regulations equivalent to paragraph (2) of Rule
0400-20-10-.10.
2. Reports required by subparts
1(i), (ii) and (iii) of this subparagraph shall identify:
(i) Each general licensee by name and mailing
address for the location of use; if there is no mailing address for the
location of use, an alternate address for the general licensee shall be
submitted along with information on the actual location of use;
(ii) The name, title and phone number of the
person identified by the general licensee as having knowledge of and authority
to take required actions to ensure compliance with the appropriate regulations
and requirements;
(iii) The date of
transfer;
(iv) The type, model
number and serial number of the device transferred; and
(v) The quantity and type of radioactive
material contained in the device.
3. If one or more intermediate persons will
temporarily possess the device at the intended place of use prior to its
possession by the user, the report shall include the same information for both
the intended user and each intermediate person, and clearly designate the
intermediate person(s).
4. For
devices received from a general licensee, the report shall include the identity
of the general licensee by name and address, the type, model number and serial
number of the device received, the date of receipt, and, in the case of devices
not initially transferred by the reporting licensee, the name of the
manufacturer or initial transferor.
5. If the licensee makes changes to a device
possessed by a general licensee, such that the label must be changed to update
required information, the report shall identify the general licensee, the
device, and the changes to information on the device label.
6.
(i) The
report shall cover each calendar quarter, shall be filed within 30 days of the
end of the calendar quarter, and shall clearly indicate the period covered by
the report.
(ii) The report shall
clearly identify the specific licensee submitting the report and include the
license number of the specific licensee.
(iii) If no transfers have been made to or
from persons generally licensed under paragraph (2) of Rule
0400-20-10-.10
during the reporting period, the report shall so indicate.
(h) Each person licensed under
this paragraph to distribute devices to generally licensed persons shall keep
records showing the name, address of use, and responsible individual for each
general licensee to whom he directly or through an intermediate person
transfers radioactive material in devices for use pursuant to the general
license provided in paragraph (2) of Rule
0400-20-10-.10
or equivalent regulations of the U.S. Nuclear Regulatory Commission, an
Agreement State or a Licensing State. The records shall show the date of each
transfer, the model number, serial number and the isotope and quantity of
radioactivity in each device transferred, the identity of any intermediate
person(s), and compliance with the report requirements of subparagraph (g) of
this paragraph. The records required by this subparagraph shall be maintained
for a period of 3 years from the date of the recorded
event.
(6) The use of
sealed sources in industrial radiography.
In addition to the requirements set forth in Rule 0400-20-10-.12, a specific license for use of sealed sources in industrial radiography will be issued only if:
(a) The applicant will
have a program for training radiographers and radiographer's assistants and
submits to the Division for approval a schedule or description of such program
which specifies the:
1. Initial training:
(i) This initial training will consist of a
complete training program as outlined in Rule
0400-20-08-.07;
or
(ii) Résumés of
prior training and experience of individuals that show fulfillment of the
requirements of subparagraphs (7)(a) and (b) of Rule
0400-20-08-.07
and the program for the initial training of such individuals in the licensee's
or registrant's specific industrial radiography program as outlined in
subparagraphs (7)(c), (d) and (e) of Rule
0400-20-08-.07;
2. Periodic training;
3. On-the-job training;
4. Means to be used by the applicant to
determine the radiographer's knowledge and understanding of and ability to
comply with Division regulations and licensing requirements and the operating
and emergency procedures of the applicant; and
5. Means to be used by the applicant to
determine the radiographer's assistant's knowledge and understanding of and
ability to comply with the operating and emergency procedures of the
applicant;
(b) The
applicant has established and submits to the Division for approval written
operating and emergency procedures as described in paragraph (2) of Rule
0400-2008-.05;
(c) The applicant
will have an internal inspection system to assure that Division regulations,
license provisions, and the applicant's operating and emergency procedures are
followed by radiographers and radiographer's assistants; the inspection system
shall include the performance of internal inspections at intervals not to
exceed 3 months and the retention of records of such inspections for inspection
by the Division.
(d) The applicant
submits to the Division a description of his overall organizational structure
pertaining to the radiography program, including specified delegations of
authority and responsibility for operation of the program; and
(e) The applicant who desires to conduct his
own leak tests must establish procedures to be followed in testing sealed
sources for possible leakage and contamination and submit to the Division for
approval a description of such procedures including:
1. Instrumentation to be used;
2. Method of performing tests, e.g., points
on equipment to be smeared and method of taking smear; and
3. Pertinent experience of the person who
will perform the test.
(7) Multiple quantities or types of
radioactive material for use in processing.
In addition to the requirements set forth in Rule
0400-20-10-.12,
a specific license for multiple quantities or types of radioactive material for
use in processing for distribution to other authorized persons will be issued
only if
(a) The applicant's staff has experience in
the use of radioisotopes for processing and distribution; and
(b) The applicant has appointed a
radiological safety officer who will advise and assist on radiological safety
problems.
(8)
Introduction of radioactive material into products in exempt concentrations.
In addition to the requirements set forth in Rule 0400-20-10-.12, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under subparagraph (1)(a) of Rule 0400-20-10-.04 will be issued only if:
(a) The
applicant submits a description of the product or material into which the
radioactive material will be introduced, intended use of the radioactive
material and the product or material into which it is introduced, method of
introduction, initial concentration of the radioactive material in the product
or material, control methods to assure that no more than the specified
concentration is introduced into the product or material, estimated time
interval between introduction and transfer of the product or material and
estimated concentration of the radioactive material in the product or material
at the time of transfer; and
(b)
The applicant provides assurance that the concentrations of radioactive
material at the time of transfer will not exceed the concentrations in Schedule
RHS 8-4, that reconcentration of the radioactive material in concentrations
exceeding those in Schedule RHS 8-4 is not likely, that lower concentrations
cannot be used, and that the product or material is not likely to be
incorporated in any food, beverage, cosmetic, drug, or other commodity or
product designed for ingestion or inhalation by, or application to, a human
being. Each person licensed under this paragraph, shall file an annual report
with the Division which shall identify the type and quantity of each product or
material into which radioactive material has been introduced during the
reporting period, name and address of the person who owns or possesses the
product or material into which radioactive material has been introduced at the
time of introduction, the type and quantity of radioactive material introduced
into each product or material, and the initial concentrations of radioactive
material in the product or material at the tie of transfer of the radioactive
material by the licensee. If no transfers of radioactive material have been
made pursuant to this paragraph during the reporting period, the report shall
so indicate. The report shall be submitted within 30 days after the end of each
calendar year.
(9)
Radioactive material in luminous safety devices for use in aircraft.
In addition to the requirements set forth in Rule 0400-20-10-.12, a specific license to manufacture, assemble, repair, or distribute to persons generally licensed under paragraph (3) of Rule 0400-20-10-.10 luminous safety devices containing radioactive materials for use in aircraft will be issued only if the requirements of Sections 32.53, 32.54, 32.55, 32.56 and 32.101 of 10 CFR Part 32 or their equivalent are met.
(10) Manufacture, preparation or transfer for
commercial distribution of radiopharmaceuticals containing radioactive material
for medical use.
(a) An application for a
specific license to manufacture, prepare, or transfer for commercial
distribution radiopharmaceuticals containing radioactive material for use by
persons authorized pursuant to Chapter 0400-20-07 will be approved if:
1. The applicant satisfies the general
requirements specified in Rule 0400-20-10.12;
2. The applicant submits evidence that the
applicant is at least one of the following:
(i) Registered or licensed with the U.S. Food
and Drug Administration (FDA) as the owner or operator of a drug establishment
that engages in the manufacture, preparation, propagation, compounding, or
processing of a drug under
21 CFR
207.20(a);
(ii) Registered or licensed with a state
agency as a drug manufacturer;
(iii) Licensed as a pharmacy by the Tennessee
Board of Pharmacy;
(iv) Operating
as a nuclear pharmacy within a Federal medical institution; or
(v) A Positron Emission Tomography (PET) drug
production facility registered with a state agency.
3. The applicant submits information on the
radionuclide; chemical and physical form; packaging including maximum activity
per vial, syringe, generator or other container of the radioactive drug; and
shielding provided by the packaging of the radioactive material for safe
handling and storage of radiopharmaceuticals by medical use licensees;
and
4. The applicant satisfies the
following labeling requirements:
(i) A label
is affixed to each transport radiation shield, whether it is constructed of
lead, glass, plastic or other material, of a radioactive drug to be transferred
for commercial distribution. The label shall include the radiation symbol and
the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL";
the name of the radioactive drug or its abbreviation; and the quantity of
radioactivity at a specified date and time. For radioactive drugs with a
half-life greater than 100 days, the time may be omitted.
(ii) A label is affixed to each syringe, vial
or other container used to hold a radioactive drug to be transferred for
commercial distribution. The label shall include the radiation symbol and the
words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an
identifier that ensures that the syringe, vial or other container can be
correlated with the information on the transport radiation shield
label.
(b) A
licensee described by subpart (a)2(iii) of this paragraph:
1. May prepare radiopharmaceuticals for
medical use, as defined in Rule 0400-2007-.05, provided that the
radiopharmaceuticals are prepared by either an authorized nuclear pharmacist,
as specified in parts 2 and 4 of this subparagraph, or an individual under the
supervision of an authorized nuclear pharmacist as specified in Rule
0400-20-07-.19.
2. May allow a pharmacist to work as an
authorized nuclear pharmacist if:
(i) This
individual qualifies as an authorized nuclear pharmacist as defined in Rule
0400-20-07-.05,
(ii) This individual meets the requirements
specified in paragraph (2) of Rule
0400-20-07-.25
and Rule
0400-20-07-.27,
and the licensee has received an approved license amendment identifying this
individual as an authorized nuclear pharmacist; or
(iii) This individual is designated as an
authorized nuclear pharmacist in accordance with part 4 of this
subparagraph.
3. The
actions authorized in parts 1 and 2 of this subparagraph are permitted in spite
of more restrictive language in license conditions.
4. May designate a pharmacist (as defined in
Rule
0400-20-07-.05 ) as
an authorized nuclear pharmacist if:
(i) The
individual was a nuclear pharmacist at a Government agency or Federally
recognized Indian Tribe before November 30, 2007 or at all other pharmacies
before August 8, 2009, or an earlier date as noticed by the NRC.
5. Shall provide to the Division a
copy of each individual's:
(i) Certification
by a specialty board whose certification process has been recognized by the
Division, U.S. Nuclear Regulatory Commission or an Agreement State as specified
in paragraph (1) of Rule
0400-20-07-.25
with the written attestation signed by a preceptor as required by subparagraph
(2)(b) of Rule
0400-20-07-.25;
or
(ii) The Division, U.S. Nuclear
Regulatory Commission or other Agreement State license; or
(iii) NRC master materials licensee permit;
or
(iv) The permit issued by a
licensee or NRC master materials permittee of broad scope or the authorization
from a commercial nuclear pharmacy authorized to list its own authorization
nuclear pharmacist; or
(v)
Documentation that only accelerator-produced radioactive materials were used in
the practice of nuclear pharmacy at a Government agency or Federally recognized
Indian Tribe before November 30, 2007 or at all other locations of use before
August 8, 2009, or an earlier date as noticed by the NRC; and
(vi) A copy of the state pharmacy licensure
or registration, no later than 30 days after the date that the licensee allows,
the individual to work as an authorized nuclear pharmacist under subparts 2(i)
and (ii) of this subparagraph.
(c) A licensee shall possess and use
instrumentation to measure the radioactivity of radioactive drugs. The licensee
shall have procedures for use of the instrumentation. The licensee shall
measure by direct measurement or by combination of measurements and
calculations, the amount of radioactivity in dosages of alpha-, beta-, or
photon-emitting radioactive drugs before transfer for commercial distribution.
In addition, the licensee shall:
1. Perform
tests before initial use, periodically and following repair, on each instrument
for accuracy, linearity and geometry dependence, as appropriate for the use of
the instrument; and make adjustments when necessary; and
2. Check each instrument for constancy and
proper operation at the beginning of each day of use.
(d) Nothing in this rule relieves the
licensee from complying with applicable FDA, other federal and state
requirements governing radioactive drugs.
(11) Manufacture and distribution of
generators or reagent kits for preparation of radiopharmaceuticals containing
radioactive material. In addition to the requirements set forth in Rule
0400-20-10-.12,
a specific license to manufacture and distribute generators or reagent kits
containing radioactive material for preparation of radiopharmaceuticals by
persons licensed pursuant to Chapter 0400-20-07 will be issued only
if12 :
(a) The requested site for manufacture and/or
distribution of generators or reagent kits is located within this
State;
(b) The applicant submits
evidence that:
1. The generator or reagent kit
is to be manufactured, labeled and packaged in accordance with the Federal
Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new
drug application (NDA) approved by the United States Food and Drug
Administration (FDA), a biologic product license issued by FDA or a "Notice of
Claimed Investigational Exemption for a New Drug" (IND) accepted by FDA;
or
2. The manufacture and
distribution of the generator or reagent kit are not subject to the Federal
Food, Drug and Cosmetic Act and the Public Health Service Act;
(c) The applicant submits
information on the radionuclide, chemical and physical form, packaging
including maximum activity per package, and shielding provided by the packaging
of the radioactive material contained in the generator or reagent
kit;
(d) The label affixed to the
generator or reagent kit contains information on the radionuclide, quantity and
date of assay;
(e) The label
affixed to the generator or reagent kit, or the leaflet or brochure which
accompanies the generator or reagent kit, contains:
1. Information, from a radiation safety
standpoint, on the procedures to be followed and the equipment and shielding to
be used in eluting the generator or processing radioactive material with the
reagent kit; and
2. A statement
that this generator or reagent kit, as appropriate, is approved for use by
persons licensed by the Division pursuant to Chapter 0400-20-07 of these rules,
or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an
Agreement State or a Licensing State; and
(f) The labels, leaflets or brochures
required by subparagraphs (d) and (e) of this paragraph are in addition to the
labeling required by the FDA and they may be separate from or, with the
approval of FDA, may be combined with the labeling required by FDA.
(12) Manufacture and distribution
of sources or devices containing radioactive material for medical uses.
(a) In addition to the requirements set forth
in Rule
0400-20-10-.12,
an application for a specific license to manufacture and distribute sources and
devices containing radioactive material to persons licensed under Chapter
0400-20-07 of these rules for use as a calibration, transmission, or reference
source or for the uses listed in Rules
0400-20-07-.51,
0400-20-07-.61,
0400-20-07-.63,
and
0400-20-07-.81
will be approved if:
1. The applicant
satisfies the general requirements in Rule
0400-20-10-.12.
2. The applicant submits information
regarding each type of source or device pertinent to an evaluation of its
radiation safety, including:
(i) The
radioactive material contained, its chemical and physical form and
amount;
(ii) Details of design and
construction of the source or device;
(iii) Procedures for, and results of,
prototype tests to demonstrate that the source or device will maintain its
integrity under stresses likely to be encountered;
(iv) For devices containing radioactive
material, the radiation profile of a prototype device;
(v) Details of quality control procedures to
assure that production sources and devices meet the standards of the design and
prototype tests;
(vi) Procedures
and standards for calibrating sources and devices;
(vii) Legend and methods for labeling sources
and devices as to their radioactive content; and (viii) Instructions for
handling and storing the source or device for radiation safety; these
instructions are to be included on a durable label attached to the source or
device or attached to a permanent storage container for the source or device;
provided that instructions which are too lengthy for such label may be
summarized on the label and printed in detail on a brochure which is referenced
on the label;
3. The
label affixed to the source or device, or to the permanent storage container
for the source or device, contains information on the radionuclide, quantity,
and date of assay, and a statement that the Division has approved distribution
of the (name of the source or device) to persons licensed to use radioactive
material identified in Rules
0400-20-07-.31,
0400-20-07-.51,
0400-20-07-.61,
and 0 40020-07-.63 as appropriate, and to persons who hold an equivalent
license issued by the U.S. NRC or an Agreement State.
4. The course or device has been registered
in the Sealed Source and Device Registry.
(b) In the event the applicant desires that
the source or device be required to be tested for leakage of radioactive
material at intervals longer than 6 months, the applicant shall include in his
application information to demonstrate that such longer interval is justified
by performance characteristics of the source or device or similar sources or
devices and by design features that have a significant bearing on the
probability or consequences of leakage of radioactive material from the source.
In determining the acceptable interval for test of leakage of radioactive
material, the Division will consider information that includes, but is not
limited to:
1. Primary containment (source
capsule);
2. Protection of primary
containment;
3. Method of sealing
containment;
4. Containment
construction materials;
5. Form of
contained radioactive material;
6.
Maximum temperature withstood during prototype tests;
7. Maximum pressure withstood during
prototype tests;
8. Maximum
quantity of contained radioactive material;
9. Radiotoxicity of contained radioactive
material; and
10. Operating
experience with identical sources or devices or similarly designed and
constructed devices;
(13) Manufacture and distribution of
radioactive material for certain in vitro clinical or laboratory testing under
general license.
In addition to the requirements set forth in Rule 0400-20-10-.12, a specific license to manufacture or distribute radioactive material for use under the general license of paragraph (7) of Rule 0400-20-10-.10 will be issued only if:
(a) The
radioactive material is to be prepared for distribution in prepackaged units
of:
1. Iodine-125 in units not exceeding 10
microcuries each.
2. Iodine-131 in
units not exceeding 10 microcuries each.
3. Carbon-14 in units not exceeding 10
microcuries each.
4. Hydrogen-3
(tritium) in units not exceeding 50 microcuries each.
5. Iron-59 in units not exceeding 20
microcuries each.
6. Cobalt-57 in
units not exceeding 10 microcuries each.
7. Selenium-75 in units not exceeding 10
microcuries each.
8. Mock
Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005
microcurie of americium-241 each.
(b) Each prepackaged unit bears a durable,
clearly visible label:
1. Identifying the
radioactive contents as to chemical form and radionuclide, and indicating that
the amount of radioactivity does not exceed 10 microcuries of iodine-131,
iodine-125, cobalt-57, selenium-75, or carbon-14; 50 microcuries of hydrogen-3
(tritium); 20 microcuries of iron-59; or Mock Iodine-125 in units not exceeding
0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each;
and
2. Displaying the radiation
caution symbol described in Rule
0400-20-05-.110 and
the words, "Caution, Radioactive Material" and "Not for Internal or External
Use in Humans or Animals."
(c) 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::
1. 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 there from, 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)
(d) The label affixed to the unit, or the
leaflet or brochure which accompanies the package, contains adequate
information as to the precautions to be observed in handling and storing such
radioactive material. In the case of the Mock Iodine-125 reference or
calibration source, the information accompanying the source must also contain
directions to the licensee regarding the waste disposal requirements set out in
Rule
0400-20-05-.120.
(14) Distribution of radioactive
material in exempt quantities13 .
(a) An application for a specific license to
distribute NARM to persons exempt from these rules pursuant to paragraph (3) of
Rule
0400-20-10-.04
will be approved if:
1. The radioactive
material is not contained in any food, beverage, cosmetic, drug, or other
commodity designed for ingestion or inhalation by, or application to, a human
being;
2. The radioactive material
is in the form of processed chemical elements, compounds, or mixtures, tissue
samples, bioassay samples, counting standards, plated or encapsulated sources,
or similar substances, identified as radioactive and to be used for its
radioactive properties, but is not incorporated into any manufactured or
assembled commodity, product, or device intended for commercial distribution;
and
3. The applicant submits copies
of prototype labels and brochures and the Division approves such labels and
brochures.
(b) The
license issued under subparagraph (a) of this paragraph is subject to the
following conditions:
1. No more than 10
exempt quantities shall be sold or transferred in any single transaction.
However, an exempt quantity may be composed of fractional parts of one or more
of the exempt quantity provided the sum of the fractions shall not exceed
unity.
2. Each exempt quantity
shall be separately and individually packaged. No more that 10 such packaged
exempt quantities shall be contained in any outer package for transfer to
persons exempt pursuant to paragraph (3) of Rule 0 40020-10-.04. The outer
package shall be such that the dose rate at the external surface of the package
does not exceed 0.5 millirem per hour.
3. The immediate container of each quantity
or separately packaged fractional quantity of radioactive material shall bear a
durable, legible label which
(i) Identifies
the radionuclide and the quantity of radioactivity; and
(ii) Bears the words "Radioactive
Material."
4. In
addition to the labeling information required by part 3 of this subparagraph,
the label affixed to the immediate container, or an accompanying brochure,
shall:
(i) State that the contents are exempt
from Licensing State requirements;
(ii) Bear the words "Radioactive Material -
Not for Human Use - Incorporation into Foods, Beverages, Cosmetics, Drugs, or
Medicinals, or into Products Manufactured for Commercial Distribution is
Prohibited - Exempt Quantities Should Not Be Combined"; and
(iii) Set forth appropriate additional
radiation safety precautions and instructions relating to the handling, use,
storage and disposal of the radioactive material.
(c) Each person licensed under
this paragraph shall maintain records identifying, by name and address, each
person to whom radioactive material is transferred for use under paragraph (3)
of Rule
0400-20-10-.04
or the equivalent regulations of a Licensing State, and stating the kinds and
quantities of radioactive material transferred. An annual summary report
stating the total quantity of each radionuclide transferred under the specific
license shall be filed with the Division. Each report shall cover the year
ending June 30, and shall be filed within 30 days thereafter. If no transfers
of radioactive material have been made pursuant to this paragraph during the
reporting period, the report shall so indicate.
(15) Special requirements for license to
manufacture or initially transfer calibration sources containing americium-241,
or radium-226 for distribution to persons generally licensed under paragraph
(4) of Rule
0400-20-10-.10.
(a) An application for a specific license to
manufacture or initially transfer calibration or reference sources containing
americium-241, or radium-226 for distribution to persons generally licensed
under paragraph (4) of Rule
0400-20-10-.10
will be approved if:
1. The applicant
satisfies the general requirement of Rule
0400-20-10-.12;
and
2. The applicant submits
sufficient information regarding each type of calibration or reference source
pertinent to evaluation of the potential radiation exposure, including:
(i) Chemical and physical form and maximum
quantity of americium 241, or radium-226 in the source;
(ii) Details of construction and
design;
(iii) Details of the method
of incorporation and binding of the americium-241, or radium-226 in the
source;
(iv) Procedures for and
results of prototype testing of sources, which are designed to contain more
than 185 Bq (0.005 μCi) of americium-241, or radium-226, to
demonstrate that the americium-241, or radium-226 contained in each source will
not be released or be removed from the source under normal conditions of
use;
(v) Details of quality control
procedures to be followed in manufacture of the source;
(vi) Description of labeling to be affixed to
the source or the storage container for the source; and
(vii) Any additional information, including
experimental studies and tests, required by the Division to facilitate a
determination of the safety of the source.
3. Each source will contain no more than 185
kBq (5 µCi) of americium-241, or radium-226.
4. The Division determines, with respect to
any type of source containing more than 185 Bq (0.005 µCi) of
americium-241, or radium-226, that:
(i) The
method of incorporation and binding of the americium-241, or radium-226 in the
source is such that the americium-241, or radium-226 will not be released or be
removed from the source under normal conditions of use and handling of the
source; and
(ii) The source has
been subjected to and has satisfactorily passed appropriate tests prescribed by
part 5 of this subparagraph.
5. The applicant shall subject at least five
prototypes of each source that is designed to contain more than 0.185
kilobecquerel (0.005 microcurie) of americium-241 or radium-226 to tests as
follows:
(i) The initial quantity of
radioactive material deposited on each source is measured by direct counting of
the source.
(ii) The sources are
subjected to tests that adequately take into account the individual, aggregate,
and cumulative effects of environmental conditions expected in service that
could adversely affect the effective containment or binding of americium-241 or
radium-226, such as physical handling, moisture, and water immersion.
(iii) The sources are inspected for evidence
of physical damage and for loss of americium-241 or radium-226, after each
stage of testing, using methods of inspection adequate for determining
compliance with the criteria in subpart (iv) of this part.
(iv) Source designs are rejected for which
the following has been detected for any unit: Removal of more than 0.185
kilobecquerel (0.005 microcurie) of americium-241 or radium-226 from the source
or any other evidence of physical damage.
(b) Reserved.
(c) Labeling of devices.
Each person licensed under subparagraph (a) of this paragraph shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement:
The receipt, possession, use and transfer of this source, Model ____________, Serial No. ___________, are subject to a general license and the regulations of the NRC or an Agreement State. Do not remove this label.
CAUTION-RADIOACTIVE MATERIAL-
THIS SOURCE CONTAINS AMERICIUM-241 [OR RADIUM-226].
DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
_________________________________
Name of manufacturer or initial transferor
(d) Leak testing of each source. Each person
licensed under subparagraph (a) of this paragraph shall perform a dry wipe test
upon each source containing more than 3.7 kBq (0.1 µCi) of americium-241,
or radium 226 prior to transferring the source to a general licensee under
paragraph (4) of Rule
0400-20-10-.10.
This test must be performed by wiping the entire radioactive surface of the
source with a filter paper with the application of moderate finger pressure.
The radioactivity on the filter paper must be measured by using methods capable
of detecting 185 Bq (0.005 µCi) of americium-241, or radium-226. If a
source has been shown to be leaking or losing more than 185 Bq (0.005
µCi) of americium-241 or radium-226 by the methods described in this
subparagraph, the source must be rejected and must not be transferred to a
general licensee under paragraph (4) of Rule
0400-20-10-.10
or equivalent regulations of the NRC or an Agreement State.
(16) Reserved.
(17) Ice detection devices containing
strontium-90; requirements for license to manufacture or initially transfer;
quality assurance; prohibition of transfer.
(a) An application for a specific license to
manufacture or initially transfer ice detection devices containing strontium-90
for distribution to persons generally licensed under Rule
0400-20-10-.10
will be approved if:
1. The applicant
satisfies the general requirements specified in Rule 0400-20-10.12;
2. The applicant submits sufficient
information regarding each type of device pertinent to evaluation of the
potential radiation exposure, including:
(i)
Chemical and physical form and maximum quantity of strontium-90 in the
device;
(ii) Details of
construction and design of the source of radiation and its shielding;
(iii) Radiation profile of a prototype
device;
(iv) Procedures for and
results of prototype testing of devices to demonstrate that the strontium-90
contained in each device will not be released or be removed from the device
under the most severe conditions likely to be encountered in normal handling
and use;
(v) Details of quality
control procedures to be followed in manufacture of the device;
(vi) Description of labeling to be affixed to
the device;
(vii) Instructions for
handling and installation of the device;
(viii) Any additional information, including
experimental studies and tests, required by the Division to facilitate a
determination of the safety of the device;
3. Each device will contain no more than 50
microcuries of strontium-90 in an insoluble form;
4. Each device will bear durable, legible
labeling which includes the radiation caution symbol prescribed by Rule
0400-20-05-.110, a
statement that the device contains strontium-90 and the quantity thereof,
instructions for disposal and statements that the device may be possessed
pursuant to a general license, that the manufacturer or civil authorities
should be notified if the device is found, that removal of the labeling is
prohibited and that disassembly and repair of the device may be performed only
by a person holding a specific license to manufacture or service such
devices;
5. The Division determines
that:
(i) The method of incorporation and
binding of the strontium-90 in the device is such that the strontium-90 will
not be released from the device under the most severe conditions which are
likely to be encountered in normal use and handling of the device;
(ii) The strontium-90 is incorporated or
enclosed so as to preclude direct physical contact by any individual with it
and is shielded so that no individual will receive a radiation exposure to a
major portion of his body in excess of 0.5 rem in a year under ordinary
circumstances of use;
(iii) The
device is so designed that it cannot be easily disassembled;
(iv) Prototypes of the device have been
subjected to and have satisfactorily passed the tests required by subparagraph
(b) of this paragraph.
(v) Quality
control procedures have been established to satisfy the requirements of
subparagraph (c) of this paragraph.
6. The device has been registered in the
Sealed Source and Device Registry.
(b) The applicant shall subject at least five
prototypes of the device to tests as follows:
1. The devices are subjected to tests that
adequately take into account the individual, aggregate, and cumulative effects
of environmental conditions expected in service that could adversely affect the
effective containment of strontium-90, such as temperature, moisture, absolute
pressure, water immersion, vibration, shock, and weathering.
2. The devices are inspected for evidence of
physical damage and for loss of strontium-90 after each stage of testing, using
methods of inspection adequate for determining compliance with the criteria in
part 3 of this subparagraph.
3.
Device designs are rejected for which the following has been detected for any
unit:
(i) A leak resulting in a loss of 0.1
percent or more of the original amount of strontium-90 from the device;
or
(ii) Surface contamination of
strontium-90 on the device of more than 2,200 disintegrations per minute per
100 square centimeters of surface area; or
(iii) Any other evidence of physical
damage.
(c)
1. Each person licensed under this paragraph
shall visually inspect each device and shall reject any which has an observable
physical defect that could affect containment of the strontium-90.
2. Each person licensed under this paragraph
shall test each device for possible loss of strontium-90 or for contamination
by wiping with filter paper an area of at least 100 square centimeters on the
outside surface of the device, or by wiping the entire surface area if it is
less than 100 square centimeters. The detection on the filter paper of more
than 2,200 disintegrations per minute of radioactive material per 100 square
centimeters of surface wiped shall be cause for rejection of the tested
device.
3. Each person licensed
under this paragraph shall:
(i) Maintain
quality assurance systems in the manufacture of the ice detection device
containing strontium-90 in a manner sufficient to provide reasonable assurance
that the safety-related components of the distributed devices are capable of
performing their intended functions; and
(ii) Subject inspection lots to acceptance
sampling procedures, by procedures specified in part 4 of this subparagraph and
in the license issued under this paragraph, to provide at least 95 percent
confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be
exceeded.
4. Each person
licensed under this paragraph shall subject each inspection lot to:
(i) Tests that adequately take into account
the individual, aggregate, and cumulative effects of environmental conditions
expected in service that could possibly affect the effective containment of
strontium-90, such as absolute pressure and water immersion.
(ii) Inspection for evidence of physical
damage, containment failure, or for loss of strontium-90 after each stage of
testing, using methods of inspection adequate to determine compliance with the
following criteria for defective: A leak resulting in a loss of 0.1 percent or
more of the original amount of strontium-90 from the device and any other
criteria specified in the license issued under this paragraph.
5. No person licensed under this
paragraph shall transfer to persons generally licensed under paragraph (6) of
Rule
0400-20-10-.10,
or under an equivalent general license of an Agreement State:
(i) Any ice detection device containing
strontium-90 tested and found defective under the criteria specified in a
license issued under this paragraph, unless the defective ice detection device
has been repaired or reworked, retested, and determined by an independent
inspector to meet the applicable acceptance criteria; or
(ii) Any ice detection device containing
strontium-90 contained within any lot that has been sampled and rejected as a
result of the procedures in subpart 3(ii) of this subparagraph, unless:
(I) A procedure for defining sub-lot size,
independence, and additional testing procedures is contained in the license
issued under this paragraph, and
(II) Each individual sub-lot is sampled,
tested, and accepted in accordance with subpart 3(ii) of this subparagraph and
item (I) of this subpart and any other criteria as may be required as a
condition of the license issued under this paragraph.
(18)
Registration of sealed source and device product information.
(a) Any manufacturer or initial distributor
of a sealed source or device containing a sealed source may submit a request to
the Division for evaluation of radiation safety information about its product
and for its registration.
(b) The
request for review must be sent to the Tennessee Division of Radiological
Health at the address given in subparagraph (1)(c) of Rule
0400-20-04-.07.
(c) The request for review of a sealed source
or a device must include sufficient information about the design, manufacture,
prototype testing, quality control program, labeling, proposed uses and leak
testing and, for a device, the request must also include sufficient information
about installation, service and maintenance, operating and safety instructions,
and its potential hazards, to provide reasonable assurance that the radiation
safety properties of the source or device are adequate to protect health and
minimize danger to life and property.
(d) The Division normally evaluates a sealed
source or a device using radiation safety criteria in accepted industry
standards. If these standards and criteria do not readily apply to a particular
case, the Division formulates reasonable standards and criteria with the help
of the manufacturer or distributor. The Division shall use criteria and
standards sufficient to ensure that the radiation safety properties of the
device or sealed source are adequate to protect health and minimize danger to
life and property. Rule
0400-20-10-.04
includes specific criteria that apply to certain exempt products and Rule
0400-20-10-.10
includes specific criteria applicable to certain generally licensed devices.
This rule includes specific provisions that apply to certain specifically
licensed items.
(e) After
completion of the evaluation, the Division issues a certificate of registration
to the person making the request. The certificate of registration acknowledges
the availability of the submitted information for inclusion in an application
for a specific license proposing use of the product, or concerning use under an
exemption from licensing or general license as applicable for the category of
certificate.
(f) The person
submitting the request for evaluation and registration of safety information
about the product shall manufacture and distribute the product in accordance
with:
1. The statements and representations,
including quality control program, contained in the request; and
2. The provisions of the registration
certificate.
(g)
Authority to manufacture or initially distribute a sealed source or device to
specific licensees may be provided in the license without the issuance of a
certificate of registration in the following cases:
1. Calibration and reference sources
containing no more than:
(i) 37 MBq (1 mCi),
for beta and/or gamma emitting radionuclides; or
(ii) 0.37 MBq (10 µCi), for alpha
emitting radionuclides; or
2. The intended recipients are qualified by
training and experience and have sufficient facilities and equipment to safely
use and handle the requested quantity of radioactive material in any form in
the case of unregistered sources or, for registered sealed sources contained in
unregistered devices, are qualified by training and experience and have
sufficient facilities and equipment to safely use and handle the requested
quantity of radioactive material in unshielded form, as specified in their
licenses; and
(i) The intended recipients are
licensed under paragraph (4) of this rule,
(ii) The recipients are authorized for
research and development; or
(iii)
The sources and devices are to be built to the unique specifications of the
particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4
GBq (200 mCi) of any other radionuclide.
(h) After the certificate is issued, the
Division may conduct an additional review as it determines is necessary to
ensure compliance with current regulatory standards. In conducting its review,
the Division will complete its evaluation in accordance with criteria specified
in this paragraph. The Division may request such additional information as it
considers necessary to conduct its review and the certificate holder shall
provide the information as requested.
(19) Inactivation of certificates of
registration of sealed sources and devices.
(a) A certificate holder who no longer
manufactures or initially transfers any of the sealed source(s) or device(s)
covered by a particular certificate issued by the Division shall request
inactivation of the registration certificate. Such a request must be made to
the Tennessee Division of Radiological Health at the address given in
subparagraph (1)(c) of Rule
0400-20-04-.07
and must normally be made no later than two years after initial distribution of
all of the source(s) or device(s) covered by the certificate has ceased.
However, if the certificate holder determines that an initial transfer was in
fact the last initial transfer more than two years after that transfer, the
certificate holder shall request inactivation of the certificate within 90 days
of this determination and briefly describe the circumstances of the
delay.
(b) If a distribution
license is to be terminated in accordance with Rule
0400-20-10-.17,
the licensee shall request inactivation of its registration certificates
associated with that distribution license before the Division will terminate
the license. Such a request for inactivation of certificate(s) must indicate
that the license is being terminated and include the associated specific
license number.
(c) A specific
license to manufacture or initially transfer a source or device covered only by
an inactivated certificate no longer authorizes the licensee to initially
transfer such sources or devices for use. Servicing of devices must be in
accordance with any conditions in the certificate, including in the case of an
inactive certificate.
(20) Emergency preparedness.
(a) Emergency preparedness for possession of
radioactive material other than uranium and plutonium.
1. In addition to the requirements set forth
in Rule
0400-20-10-.12,
all specific licenses issued, or for which an initial application or an
application to amend is submitted, to possess radioactive materials in unsealed
form, on foils or plated sources, or sealed in glass in excess of the
quantities in Table RHS 7-2 must contain either:
(i) An evaluation showing that the maximum
dose to a person offsite due to a release of radioactive materials would not
exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or
(ii) An emergency plan for responding to a
release of radioactive material.
2. One or more of the following factors may
be used to support an evaluation submitted under subpart 1(i) of this
subparagraph:
(i) The radioactive material is
physically separated so that only a portion could be involved in an
accident;
(ii) All or part of the
radioactive material is not subject to release during an accident because of
the way it is stored or packaged;
(iii) The release fraction in the respirable
size range would be lower than the release fraction shown in Table RHS 7-2 due
to the chemical or physical form of the material;
(iv) The solubility of the radioactive
material would reduce the dose received;
(v) Facility design or engineered safety
features in the facility would cause the release fraction to be lower than
shown in Table RHS 7-2;
(vi)
Operating restrictions or procedures would prevent a release fraction as large
as that shown in Table RHS 7-2; or
(vii) Other factors appropriate for the
specific facility.
Table RHS 7-2
Quantities of radioactive materials requiring consideration of the need for an emergency plan for responding to a release.
|
Radioactive material1 |
Release fraction |
Quantity (curies) |
|
Actinium-228 |
0.001 |
4,000 |
|
Americium-241 |
0.001 |
2 |
|
Americium-242 |
0.001 |
2 |
|
Americium-243 |
0.001 |
2 |
|
Antimony-124 |
0.01 |
4,000 |
|
Antimony-126 |
0.01 |
6,000 |
|
Barium-133 |
0.01 |
10,000 |
|
Barium-140 |
0.01 |
30,000 |
|
Bismuth-207 |
0.01 |
5,000 |
|
Bismuth-210 |
0.01 |
600 |
|
Cadmium-109 |
0.01 |
1,000 |
|
Cadmium-113 |
0.01 |
80 |
|
Calcium-45 |
0.01 |
20,000 |
|
Californium-252 |
0.001 |
9 (20 mg) |
|
Carbon-14 |
0.01 |
50,000 |
|
Cerium-141 |
0.01 |
10,000 |
|
Cerium-144 |
0.01 |
300 |
|
Cesium-134 |
0.01 |
2,000 |
|
Cesium-137 |
0.01 |
3,000 |
|
Chlorine-36 |
0.5 |
100 |
|
Chromium-51 |
0.01 |
300,000 |
|
Cobalt-60 |
0.001 |
5,000 |
|
Copper-64 |
0.01 |
200,000 |
|
Curium-242 |
0.001 |
60 |
|
Curium-243 |
0.001 |
3 |
|
Curium-244 |
0.001 |
4 |
|
Curium-245 |
0.001 |
2 |
|
Europium-152 |
0.01 |
500 |
|
Europium-154 |
0.01 |
400 |
|
Europium-155 |
0.01 |
3,000 |
|
Germanium-68 |
0.01 |
2,000 |
|
Gadolinium-153 |
0.01 |
5,000 |
|
Gold-198 |
0.01 |
30,000 |
|
Hafnium-172 |
0.01 |
400 |
|
Hafnium-181 |
0.01 |
7,000 |
|
Holmium-166m |
0.01 |
100 |
|
Hydrogen-3 |
0.5 |
20,000 |
|
Iodine-125 |
0.5 |
10 |
|
Iodine-131 |
0.5 |
10 |
|
Indium-114m |
0.01 |
1,000 |
|
Iridium-192 |
0.001 |
40,000 |
|
Iron-55 |
0.01 |
40,000 |
|
Iron-59 |
0.01 |
7,000 |
|
Krypton-85 |
1.0 |
6,000,000 |
|
Lead-210 |
0.01 |
8 |
|
Manganese-56 |
0.01 |
60,000 |
|
Mercury-203 |
0.01 |
10,000 |
|
Molybdenum-99 |
0.01 |
30,000 |
|
Neptunium-237 |
0.001 |
2 |
|
Nickel-63 |
0.01 |
20,000 |
|
Niobium-94 |
0.01 |
300 |
|
Phosphorus-32 |
0.5 |
100 |
|
Phosphorus-33 |
0.5 |
1,000 |
|
Polonium-210 |
0.01 |
10 |
|
Potassium-42 |
0.01 |
9,000 |
|
Promethium-145 |
0.01 |
4,000 |
|
Promethium-147 |
0.01 |
4,000 |
|
Radium-226 |
0.001 |
100 |
|
Ruthenium-106 |
0.01 |
200 |
|
Samarium-151 |
0.01 |
4,000 |
|
Scandium-46 |
0.01 |
3,000 |
|
Selenium-75 |
0.01 |
10,000 |
|
Silver-110m |
0.01 |
1,000 |
|
Sodium-22 |
0.01 |
9,000 |
|
Sodium-24 |
0.01 |
10,000 |
|
Strontium-89 |
0.01 |
3,000 |
|
Strontium-90 |
0.01 |
90 |
|
Sulfur-35 |
0.5 |
900 |
|
Technetium-99 |
0.01 |
10,000 |
|
Technetium-99m |
0.01 |
400,000 |
|
Tellurium-127m |
0.01 |
5,000 |
|
Tellurium-129m |
0.01 |
5,000 |
|
Terbium-160 |
0.01 |
4,000 |
|
Thulium-170 |
0.01 |
4,000 |
|
Tin-113 |
0.01 |
10,000 |
|
Tin-123 |
0.01 |
3,000 |
|
Tin-126 |
0.01 |
1,000 |
|
Titanium-44 |
0.01 |
100 |
|
Vanadium-48 |
0.01 |
7,000 |
|
Xenon-133 |
1.0 |
900,000 |
|
Yttrium-91 |
0.01 |
2,000 |
|
Zinc-65 |
0.01 |
5,000 |
|
Zirconium-93 |
0.01 |
400 |
|
Zirconium-95 |
0.01 |
5,000 |
|
Any other beta-gamma emitter |
0.01 |
10,000 |
|
Mixed fission products |
0.01 |
1,000 |
|
Mixed corrosion products |
0.01 |
10,000 |
|
Contaminated equipment beta-gamma |
0.001 |
10,000 |
|
Irradiated material, any form other than |
||
|
solid noncombustible |
0.01 |
1,000 |
|
Irradiated material, solid noncombustible |
0.001 |
10,000 |
|
Mixed radioactive waste, beta-gamma |
0.01 |
1,000 |
|
Packaged mixed waste, beta-gamma2 |
0.001 |
10,000 |
|
Any other alpha emitter |
0.001 |
2 |
|
Contaminated equipment, alpha |
0.0001 |
20 |
|
Packaged waste, alpha2 |
0.0001 |
20 |
|
Combinations of radioactive materials list |
ed above1 |
1 For combinations of radioactive materials, consideration of the need for an emergency plan is required if the sum of the ratios of the quantity of each radioactive material authorized to the quantity listed for that material in Table RHS 7-2 exceeds one.
2 Waste packaged in Type B containers does not require an emergency plan.
(b) Emergency preparedness for
possession of uranium hexafluoride.
1. In
addition to the requirements set forth in Rule
0400-20-10-.12,
all specific licenses to possess uranium hexafluoride in excess of 50 kilograms
in a single container or 1000 kilograms total must contain either:
(i) An evaluation showing that the maximum
intake of uranium by a member of the public due to a release would not exceed 2
milligrams; or
(ii) An emergency
plan for responding to the radiological hazards of an accidental release of
source material and to any associated chemical hazards directly incident
thereto.
2. One or more
of the following factors may be used to support an evaluation submitted under
subpart 1(i) of this subparagraph:
(i) All or
part of the radioactive material is not subject to release during an accident
because of the way it is stored or packaged;
(ii) Facility design or engineered safety
features in the facility would reduce the amount of the release; or
(iii) Other factors appropriate for the
specific facility.
(c) Emergency preparedness for possession of
plutonium.
1. In addition to the requirements
set forth in Rule
0400-20-10-.12,
all specific licenses to possess plutonium in excess of 2 curies in unsealed
form or on foils or plated sources must contain either:
(i) An evaluation showing that the maximum
dose to a member of the public offsite due to a release of plutonium would not
exceed 1 rem effective dose equivalent, or
(ii) An emergency plan for responding to the
radiological hazards of an accidental release of special nuclear material and
to any associated chemical hazards directly incident thereto.
2. One or more of the following
factors may be used to support an evaluation submitted under subpart 1(i) of
this subparagraph:
(i) The plutonium is
physically separated so that only a portion could be involved in an
accident;
(ii) All or part of the
plutonium is not subject to release during an accident because of the way it is
stored or packaged;
(iii) In the
case of fires or explosions, the release fraction would be lower than 0.001 due
to the chemical or physical form of the material;
(iv) The solubility of the material released
would reduce the dose received;
(v)
The facility design or engineered safety features in the facility would cause
the release fraction to be lower than 0.001;
(vi) Operating restrictions or procedures
would prevent a release large enough to cause a member of the public offsite to
receive a dose exceeding 1 rem effective dose equivalent; or
(vii) Other factors appropriate for the
specific facility.
(d) An emergency plan for responding to a
release of radioactive material submitted under subpart (a)1(ii), (b)1(ii) or
(c)1(ii) of this paragraph must include the following information:
1. Facility description.
A brief description of the licensee's facility and area near the site.
2. Types of
accidents.
An identification of each type of accident for which protective actions may be needed.
3. Classification of accidents.
A classification system for classifying accidents as alerts or site area emergencies.
4. Detection of accidents.
Identification of the means of detecting each type of radioactive materials accident in a timely manner.
5. Mitigation of consequences.
A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers onsite, and a description of the program for maintaining the equipment.
6. Assessment of
releases.
A brief description of the methods and equipment to assess releases of radioactive material.
7. Responsibilities.
A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the Division of Radiological Health; also responsibilities for developing, maintaining and updating the plan.
8. Notification and coordination.
A commitment to and a brief description of the means to
promptly notify offsite response organizations and request offsite assistance,
including medical assistance for the treatment of contaminated, injured onsite
workers when appropriate. A control point must be established. The notification
and coordination must be planned so that unavailability of some personnel,
parts of the facility, and some equipment will not prevent the notification and
coordination. The licensee shall also commit to notify the Division of
Radiological Health immediately after notification of the offsite response
organizations and not later than 1 hour after the licensee declares an
emergency.
9. Information to be communicated.
A brief description of the types of information on facility status, radioactive releases and recommended protective actions, if necessary, to be given to offsite response organizations and to the Division of Radiological Health.
10.
Training.
A brief description of the frequency, performance objectives and plan for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios.
11. Safe shutdown.
A brief description of the means of restoring the facility to a safe condition after an accident.
12. Exercises.
Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite offsite response organizations to participate in the biennial exercises. Participation of offsite response organizations in biennial exercises although recommended is not required. Exercises must use accident scenarios postulated as most probable for the specific site and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel and overall effectiveness of the response. Deficiencies found by the critiques must be corrected.
13. Hazardous chemicals.
A certification that the applicant has met its
responsibilities under the Emergency Planning and Community Right-to-Know Act
of 1986, Title III, Public
Law
(e)
The licensee shall allow the offsite response organizations expected to respond
in case of an accident 60 days to comment on the licensee's emergency plan
before submitting it to the Division of Radiological Health. The licensee shall
provide any comments received within the 60 days to the Division of
Radiological Health with the emergency plan.
(f) Licensees required to submit emergency
plans by this paragraph shall follow the emergency plan approved by the
Division of Radiological Health. The licensee may change the plan without
Division of Radiological Health approval if the changes do not decrease the
effectiveness of the plan. The licensee shall furnish the change to the
Division of Radiological Health and to affected offsite response organizations
within 6 months after the change is made. Proposed changes that decrease the
effectiveness of the approved emergency plan may not be implemented without
application to and prior approval by the Division of Radiological
Health.
Notes
Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.
If specified elsewhere in labeling affixed to the device, the model, serial number and manufacturer or distributor may be omitted from this label.
Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing by product material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, DC 20555.
Although the Department does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have reagent kits approved by the Department for use by persons licensed pursuant to Chapter 0400-20-07 may submit the pertinent information specified in this paragraph
See footnote 2 of this Chapter.
These reporting requirements do not supersede or release
licensees of complying with the requirements under the Emergency Planning and
Community Right-to-Know Act of 1986, Title III,
Public Law
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.