Utah Admin. Code R313-22-75 - Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices That Contain Radioactive Material
(1)
Licensing the introduction of radioactive material in exempt concentrations
into products or materials, and transfer of ownership or possession of the
products and materials.
(a) The authority to
introduce radioactive material in exempt concentrations into equipment,
devices, commodities or other products may be received only from the Nuclear
Regulatory Commission , Washington, D.C. 20555; and
(b) The manufacturer, processor or producer
of equipment, devices, commodities or other products containing exempt
concentrations of radioactive materials may get the authority to transfer
possession or control of the equipment, devices, commodities, or other products
containing exempt concentrations to a person who is exempt from regulatory
requirements only from the Nuclear Regulatory Commission , Washington, D.C.
20555.
(2) Licensing the
distribution of radioactive material in exempt quantities. Authority to
transfer possession or control by the manufacturer, processor or producer of
equipment, devices, commodities or other products containing byproduct material
whose subsequent possession, use, transfer, and disposal by another person who
is exempted from regulatory requirements may be received only from the Nuclear
Regulatory Commission , Washington, D.C. 20555.
(3) Reserved
(4) Licensing the manufacture and
distribution of devices to a person generally licensed under Subsection
R313-21-22(4).
(a) An application for a specific license to
manufacture or distribute devices containing radioactive material , excluding
special nuclear material, to a person generally licensed under Subsection
R313-21-22(4)
or equivalent regulations of the Nuclear Regulatory Commission , an Agreement
State or a Licensing State will be approved if:
(i) the applicant satisfies the general
requirements of Section
R313-22-33;
(ii) 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 reasonable assurance that:
(A) the
device can be safely operated by a person not having training in radiological
protection;
(B) 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 it is unlikely that a person will receive in one year , a
dose more than 10% of the annual limits specified in Subsection
R313-15-201(1);
and
(C) under accident conditions,
such as fire and explosion, associated with handling, storage, and use of the
device, it is unlikely that a person would receive an external radiation dose
or dose commitment more than the organ doses shown in Table 2;
|
TABLE 2 |
|
|
|
150.0mSv, 15 |
|
Hands and forearms, feet and ankles, localized areas of skin averaged over areas no larger than one square centimeter |
2.0 Sv, 200 |
|
Other organs |
500.0 mSv, 50 |
(iii) each device bears a durable, legible,
clearly visible label or labels approved by the director , which contain in a
clearly identified and separate statement:
(A)
instructions and precautions necessary to assure 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;
(B) the requirement, or lack of requirement,
for leak testing, or for testing an "on-off" mechanism and indicator, including
the maximum time interval for testing, and the identification of radioactive
material by radionuclide, quantity of radioactivity , and date of determination
of the quantity; and
(C) the
information called for in one of the statements in either Subsection
R313-22-75(4)(a)(iii)(C)(I)
or R313-22-75(4)(a)(iii)(C)(II),
as appropriate, in this or substantially similar form:
(I) "The receipt, possession, use and
transfer of this device, Model No. ........, Serial No. ............, are
subject to a general license or the equivalent, and the regulations of the
Nuclear Regulatory Commission or a state with which the Nuclear Regulatory
Commission 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." The label shall be printed with the words
"CAUTION -RADIOACTIVE MATERIAL " and the name of the manufacturer or distributor
shall appear on the label. The model, serial number, and name of the
manufacturer or distributor may be omitted from this label provided the
information is elsewhere specified in labeling affixed to the device;
or
(II) "The receipt, possession,
use and transfer of this device, Model No. ........., Serial No. .............,
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." The label shall be printed
with the words "CAUTION - RADIOACTIVE MATERIAL " and the name of the
manufacturer or distributor shall appear on the label. The model, serial
number, and name of the manufacturer or distributor may be omitted from this
label provided the information is elsewhere specified in labeling affixed to
the device;
(iv) 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 ,"
the radiation symbol described in Section
R313-15-901, and the name of the
manufacturer or initial distributor;
(v) each device meeting the criteria of
Subsection R313-21-22(4)(c)(xiii)(A),
bears a permanent label, for example, embossed, etched, stamped, or engraved,
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 Section
R313-15-901; and
(vi) the device has been registered in the
Sealed Source and Device Registry .
(b) In the event the applicant desires that
the device be required to be tested at intervals longer than six months, either
for proper operation of the "on-off" mechanism and indicator, if any, or for
leakage of radioactive material or for both, the applicant shall include in the
application sufficient information to demonstrate that a 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 from the device or failure of
the "on-off" mechanism and indicator. In determining the acceptable interval
for the test for leakage of radioactive material , the director will consider
information that includes:
(i) primary
containment, or source capsule;
(ii) protection of primary
containment;
(iii) method of
sealing containment;
(iv)
containment construction materials;
(v) form of contained radioactive
material ;
(vi) maximum temperature
withstood during prototype tests;
(vii) maximum pressure withstood during
prototype tests;
(viii) maximum
quantity of contained radioactive material ;
(ix) radiotoxicity of contained radioactive
material ; and
(x) operating
experience with identical devices or similarly designed and constructed
devices.
(c) In the event
the applicant desires that the general licensee under Subsection
R313-21-22(4),
or under equivalent regulations of the 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, the applicant shall include
in the application written instructions to be followed by the general licensee ,
estimated calendar quarter doses associated with this activity or activities,
and basis for these estimates. The submitted information shall demonstrate that
performance of this activity or activities by an individual untrained in
radiological protection, in addition to other handling, storage, and use of
devices under the general license , is unlikely to cause that individual to
receive a dose more than 10% of the annual limits specified in Subsection
R313-15-201(1).
(d)
(i) If
a device containing radioactive material is to be transferred for use under the
general license contained in Subsection
R313-21-22(4),
each person that is licensed under Subsection
R313-22-75(4)
shall provide the information specified in Subsections
R313-22-75(4)(d)(i)(A)
through R313-22-75(4)(d)(i)(E)
to each person to whom a device is to be transferred. This information shall be
provided before the device may be transferred. In the case of a transfer
through an intermediate person , the information shall also be provided to the
intended user before initial transfer to the intermediate person . The required
information includes:
(A) a copy of the
general license contained in Subsection
R313-21-22(4).
If Subsections R313-21-22(4)(c)(ii)
through R313-21-22(4)(c)(iv)
or R313-21-22(4)(c)(xiii)
do not apply to the particular device, those paragraphs may be
omitted;
(C) a list of services that can only be
performed by a specific licensee ;
(D) information on acceptable disposal
options including estimated costs of disposal; and
(E) an indication that the director 's policy
is to issue civil penalties for improper disposal.
(ii) If radioactive material is to be
transferred in a device for use under an equivalent general license of the
Nuclear Regulatory Commission , an Agreement State , or Licensing State , each
person that is licensed under Subsection
R313-22-75(4)
shall provide the information specified in Subsections
R313-22-75(4)(d)(ii)(A)
through R313-22-75(4)(d)(ii)(D)
to each person to whom a device is to be transferred. This information shall be
provided before the device may be transferred. In the case of a transfer
through an intermediate person , the information shall also be provided to the
intended user before initial transfer to the intermediate person . The required
information includes:
(A) a copy of an
Agreement State 's or Licensing State 's regulations equivalent to Sections
R313-12-51,
R313-15-1201,
R313-15-1202, and Subsection
R313-21-22(4)
or a copy of 10 CFR
31.5,
10 CFR
31.2,
10 CFR
30.51,
10 CFR
20.2201, and
10 CFR
20.2202. If a copy of the Nuclear Regulatory
Commission regulations is provided to a prospective general licensee in lieu of
the Agreement State 's or Licensing State 's regulations, it shall be accompanied
by a note explaining that use of the device is regulated by the Agreement State
or Licensing State . If certain paragraphs of the regulations do not apply to
the particular device, those paragraphs may be omitted;
(B) a list of services that can only be
performed by a specific licensee ;
(C) information on acceptable disposal
options including estimated costs of disposal; and
(D) the name or title, address, and phone
number of the contact at the Nuclear Regulatory Commission , Agreement State , or
Licensing State where additional information may be received.
(iii) An alternative approach to
informing customers may be proposed by the licensee for approval by the
director .
(iv) Each device that is
transferred after February 19, 2002, shall meet the labeling requirements in
Subsection R313-22-75(4)(a)(iii).
(v) If a notification of bankruptcy has been
made under Section R313-19-34 or the license is to
be terminated, each person licensed under Subsection
R313-22-75(4)
shall provide, upon request, to the Director , the Nuclear Regulatory
Commission , or an appropriate Agreement State or Licensing State , records of
final disposition required under Subsection
R313-22-75(4)(d)(vii)(H).
(vi) Each person licensed under Subsection
R313-22-75(4)
to initially transfer devices to a generally licensed person shall comply with
the requirements of Subsections
R313-22-75(4)(d)(vi)
and R313-22-75(4)(d)(vii).
(A) The person shall report each transfer of
devices to a person for use under the general license under Subsection
R313-21-22(4)
and each receipt of devices from a person licensed under Subsection
R313-21-22(4)
to the director . The report shall be submitted on a quarterly basis on Form
653, "Transfers of Industrial Devices Report" as prescribed by the Nuclear
Regulatory Commission , or in a clear and legible report containing the data
required by the form.
(B) The
required information for transfers to general licensees includes:
(I) the identity of 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 alternative 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 rules, regulations and requirements;
(III) the date of transfer;
(IV) the type, model number, and serial
number of device transferred; and
(V) the quantity and type of radioactive
material contained in the device.
(C) If one or more intermediate persons will
temporarily have the device at the intended place of use before its possession
by the user, the report shall include the information required by Subsection
R313-22-74(4)(d)(vi)(B) for both the intended user and each intermediate
person , and clearly designate the intermediate person .
(D) For devices received from a Subsection
R313-21-22(4)
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.
(E) If the licensee
makes changes to a device possessed by a Subsection
R313-21-22(4)
general licensee that would require the label to be changed to update required
information, the report shall identify the general licensee , the device, and
the changes to information on the device label.
(F) The report shall cover each calendar
quarter, shall be filed within 30 days of the end of the calendar quarter, and
shall clearly state the period covered by the report.
(G) The report shall clearly identify the
specific licensee submitting the report and include the license number of the
specific licensee .
(H) If no
transfers have been made to or from a person generally licensed under
Subsection R313-21-22(4)
during the reporting period, the report shall so state.
(vii) The person shall report each transfer
of devices to a person for use under a general license in the Nuclear
Regulatory Commission 's, an Agreement State 's, or Licensing State 's regulations
that are equivalent to Subsection
R313-21-22(4)
and each receipt of devices from general licensees in the Nuclear Regulatory
Commission 's, Agreement State 's, or Licensing State 's jurisdiction to the
Nuclear Regulatory Commission , or to the responsible Agreement State or
Licensing State agency. The report shall be submitted on Form 653, "Transfers
of Industrial Devices Report" as prescribed by the Nuclear Regulatory
Commission , or in a clear and legible report containing the data required by
the form.
(A) The required information for
transfers to general licensee includes:
(I)
the identity of 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
alternative 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 rules,
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.
(B) If one or more intermediate persons will
temporarily have the device at the intended place of use before its possession
by the user, the report shall include the information required by Subsection
R313-22-75(4)(d)(vii)(A)
for both the intended user and each intermediate person , and clearly designate
the intermediate person .
(C) 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.
(D) If the licensee makes changes to a device
possessed by a general licensee that would require the label to be changed to
update required information, the report shall identify the general licensee ,
the device, and the changes to information on the device label.
(E) The report shall cover each calendar
quarter, shall be filed within 30 days of the end of the calendar quarter, and
shall clearly state the period covered by the report.
(F) The report shall clearly identify the
specific licensee submitting the report and shall include the license number of
the specific licensee .
(G) If no
transfers have been made to or from a Nuclear Regulatory Commission licensee ,
or to or from a particular Agreement State or Licensing State licensee during
the reporting period, this information shall be reported to the Nuclear
Regulatory Commission or the responsible Agreement State or Licensing State
agency upon request of the agency.
(H) The person shall maintain any information
concerning transfers and receipts of devices that supports the reports required
by Subsection R313-22-75(4)(d)(vii).
Records required by Subsection
R313-22-75(4)(d)(vii)(H)
shall be maintained for a period of three years following the date of the
recorded event.
(5) Special requirements for the manufacture,
assembly, or repair of luminous safety devices for use in aircraft. An
application for a specific license to manufacture, assemble or repair luminous
safety devices containing tritium or promethium-147 for use in aircraft for
distribution to a person generally licensed under Subsection
R313-21-22(5)
will be approved if:
(a) the applicant
satisfies the general requirements of Section
R313-22-33; and
(6) Special
requirements for license to manufacture or initially transfer calibration
sources containing americium-241, plutonium or radium-226 for distribution to a
person generally licensed under Subsection
R313-21-22(7).
An application for a specific license to manufacture calibration and reference
sources containing americium-241, plutonium or radium-226 to a person generally
licensed under Subsection
R313-21-22(7)
will be approved if:
(a) the applicant
satisfies the general requirements of Section
R313-22-33; and
(7)
Manufacture and distribution of radioactive material for certain in vitro
clinical or laboratory testing under general license . An application for a
specific license to manufacture or distribute radioactive material for use
under the general license of Subsection
R313-21-22(9)
will be approved if:
(a) the applicant
satisfies the general requirements specified in Section
R313-22-33;
(b) the radioactive material is to be
prepared for distribution in prepackaged units of:
(i) iodine-125 in units not exceeding 370
kilobecquerel, ten uCi, each;
(ii)
iodine-131 in units not exceeding 370 kilobecquerel, ten uCi, each;
(iii) carbon-14 in units not exceeding 370
kilobecquerel, ten uCi, each;
(iv)
hydrogen-3, tritium, in units not exceeding 1.85 megabecquerel, 50 uCi,
each;
(v) iron-59 in units not
exceeding 740.0 kilobecquerel, 20 uCi, each;
(vi) cobalt-57 in units not exceeding 370
kilobecquerel, ten uCi, each;
(vii)
selenium-75 in units not exceeding 370 kilobecquerel, ten uCi, each;
or
(viii) mock iodine-125 in units
not exceeding 1.85 kilobecquerel, 0.05 uCi, of iodine-129 and 1.85
kilobecquerel, 0.05 uCi, of americium-241 each; and
(c) prepackaged units bear a durable, clearly
visible label:
(i) identifying the radioactive
contents as to chemical form and radionuclide, and indicating that the amount
of radioactivity does not exceed 370 kilobecquerel, ten uCi, of iodine-125,
iodine-131, carbon-14, cobalt-57, or selenium-75; 1.85 megabecquerel, 50 uCi,
of hydrogen-3, tritium; 740.0 kilobecquerel, 20 uCi, of iron-59; or Mock
Iodine-125 in units not exceeding 1.85 kilobecquerel, 0.05 uCi, of iodine-129
and 1.85 kilobecquerel, 0.05 uCi, of americium-241 each; and
(ii) displaying the radiation caution symbol
described in Section R313-15-901 and the words,
"CAUTION, RADIOACTIVE MATERIAL ," and "Not for Internal or External Use in
Humans or Animals";
(d)
one of the statements in either Subsection
R313-22-75(7)(d)(i)
or R313-22-75(7)(d)(ii),
as appropriate, or a substantially similar statement that contains the
information called for in one of the statements in either Subsection
R313-22-75(7)(d)(i)
or R313-22-75(7)(d)(ii),
appears on a label affixed to each prepackaged unit or appears in a leaflet or
brochure that accompanies the package :
(i)
"This radioactive material shall be received, acquired, possessed and used only
by physicians, veterinarians, clinical laboratories or hospitals and only for
in vitro clinical or laboratory tests not involving internal or external
administration of the material, or the radiation therefrom, to human beings or
animals. Its receipt, acquisition, possession, use and transfer are subject to
the regulations and a general license of the Nuclear Regulatory Commission or
of a state that the Nuclear Regulatory Commission has entered into an agreement
for the exercise of regulatory authority.
.....................
Name of Manufacturer"; or
(ii) "This radioactive material shall be
received, acquired, possessed and used only by physicians, veterinarians,
clinical laboratories or hospitals and only for in vitro clinical or laboratory
tests not involving internal or external administration of the material, or the
radiation therefrom, to human beings or animals. Its receipt, acquisition,
possession, use and transfer are subject to the regulations and a general
license of a Licensing State .
.....................
Name of Manufacturer"; and
(e) the label affixed to the unit, or the
leaflet or brochure that accompanies the package , contains adequate information
as to the precautions to be observed in handling and storing radioactive
material . In the case of the Mock Iodine-125 reference or calibration source,
the information accompanying the source shall also contain directions to the
licensee regarding the waste disposal requirements set out in Section
R313-15-1001.
(8) Licensing the manufacture and
distribution of ice detection devices. An application for a specific license to
manufacture and distribute ice detection devices to a person generally licensed
under Subsection R313-21-22(10)
will be approved if:
(a) the applicant
satisfies the general requirements of Section
R313-22-33; and
(9) Manufacture,
preparation, or transfer for commercial distribution of radioactive drugs
containing radioactive material for medical use under Rule R313-32.
(a) An application for a specific license to
manufacture and distribute radiopharmaceuticals containing radioactive material
for use by a person licensed pursuant to Rule R313-32 will be approved if:
(i) the applicant satisfies the general
requirements specified in Section
R313-22-33;
(ii) the applicant submits evidence that the
applicant is at least registered, licensed or operating as one of the entities
listed in Subsections
R313-22-75(9)(a)(ii)(A)
through R313-22-75(9)(a)(ii)(E):
(A) registered with the US 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
207.17(a);
(B) registered or licensed with a state
agency as a drug manufacturer;
(C)
licensed as a pharmacy by a state board of pharmacy;
(D) operating as a nuclear pharmacy within a
federal medical institution; or
(E)
registered with a state agency as a Positron Emission Tomography (PET) drug
production facility ;
(iii) the applicant submits information on
the radionuclide; the chemical and physical form; the maximum activity per
vial, syringe, generator, or other container of the radioactive drug; and the
shielding provided by the packaging to show it is appropriate for the safe
handling and storage of the radioactive drugs by medical use licensees;
and
(iv) the applicant commits to
the labeling requirements in either Subsection
R313-22-75(9)(a)(iv)(A)
or R313-22-75(9)(a)(iv)(B):
(A) 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.
(B) 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 Subsection
R313-22-75(9)(a)(ii)(C)
or R313-22-75(9)(a)(ii)(D):
(i) may have either an authorized nuclear
pharmacist , as specified in Subsections
R313-22-75(9)(b)(ii)
and R313-22-75(9)(b)(iv),
or an individual under the supervision of an authorized nuclear pharmacist as
specified in Rule R313-32, which incorporates
10 CFR
35.27 (2021) by reference prepare radioactive
drugs for medical use, as defined in Rule R313-32, which incorporates
10 CFR
35.2 (2021) by reference;
(ii) may allow a pharmacist to work as an
authorized nuclear pharmacist if:
(A) this
individual qualifies as an authorized nuclear pharmacist as defined in Rule
R313-32, which incorporates 10 CFR 35.2 (2021) by
reference;
(B) this individual
meets the requirements specified in Rule R313-32, which incorporates
10 CFR
35.55(b) and
10 CFR
35.59 (2021) by reference and the licensee
has received an approved license amendment identifying this individual as an
authorized nuclear pharmacist ; or
(C) this individual is designated as an
authorized nuclear pharmacist in accordance with Subsection
R313-22-75(9)(b)(iv);
(iii) the actions authorized in Subsections
R313-22-75(9)(b)(i)
and R313-22-75(9)(b)(ii)
are permitted in spite of more restrictive language in license
conditions;
(iv) may designate a
pharmacist , as defined in Rule R313-32, which incorporates
10 CFR
35.2 (2021) by reference, as an authorized
nuclear pharmacist if:
(A) the individual was
a nuclear pharmacist preparing only radioactive drugs containing accelerator
produced radioactive material ; and
(B) the individual practiced at a pharmacy at
a government agency or federally recognized Indian Tribe before November 30,
2007, or at any other pharmacies before August 8, 2009, or an earlier date as
noticed by the NRC; and
(v) shall provide to the director :
(A) a copy of each individual's certification
by a specialty board whose certification process has been recognized by the
Nuclear Regulatory Commission or Agreement State as specified in Rule R313-32,
which incorporates 10 CFR
35.55(a) (2021) by
reference; or
(B) the Nuclear
Regulatory Commission or Agreement State license ; or
(C) the permit issued by a licensee or
Commission master materials permittee of broad scope or the authorization from
a commercial nuclear pharmacy authorized to list its own authorized nuclear
pharmacist ; or
(D) the permit
issued by a US Nuclear Commission master materials licensee ; or
(E) 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 any other locations of use before August 8, 2009, or an earlier date
as noticed by the NRC; and
(F) a
copy of the state pharmacy licensure or registration , no later than 30 days
after the date that the licensee allows, pursuant to Subsections
R313-22-75(9)(b)(ii)(A)
and R313-22-75(9)(b)(ii)(C),
the individual to work as an authorized nuclear
pharmacist .
(c)
A licensee shall have 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:
(i) 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 if necessary; and
(ii)
check each instrument for constancy and proper operation at the beginning of
each day of use.
(e) Nothing in Subsection
R313-22-75(9)
relieves the licensee from complying with applicable FDA, or federal, and state
requirements governing radioactive drugs.
(10) Manufacture and distribution of sources
or devices containing radioactive material for medical use. An application for
a specific license to manufacture and distribute sources and devices containing
radioactive material to a person licensed under Rule R313-32 for use as a
calibration, transmission, or reference source or for the uses listed in Rule
R313-32, which incorporates 10 CFR 35.400,
10 CFR
35.500,
10 CFR
35.600, and
10 CFR
35.1000 (2021) by reference, will be approved
if:
(a) the applicant satisfies the general
requirements in Section
R313-22-33;
(b) the applicant submits sufficient
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; and
(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 in normal use and
accidents;
(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 from the radiation safety standpoint,
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. Instructions that are too lengthy for a label may be summarized on the
label and printed in detail on a brochure that is referenced on the
label;
(c) 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 source or device is licensed by the director
for distribution to a person licensed pursuant to Rule R313-32, which
incorporates 10 CFR
35.18,
10 CFR
35.400,
10 CFR
35.500, and
10 CFR
35.600 (2021) by reference, or under
equivalent regulations of the Nuclear Regulatory Commission , an Agreement State
or a Licensing State . Labeling for sources that do not require long term
storage may be on a leaflet or brochure that accompanies the source;
(d) the source or device has been registered
in the Sealed Source and Device Registry .
(e) 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 six months, the applicant shall include in
the application sufficient information to demonstrate that a 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.
(f) In determining the
acceptable interval for test of leakage of radioactive material , the director
shall consider information that includes:
(i)
primary containment or source capsule;
(ii) protection of primary
containment;
(iii) method of
sealing containment;
(iv)
containment construction materials;
(v) form of contained radioactive
material ;
(vi) maximum temperature
withstood during prototype tests;
(vii) maximum pressure withstood during
prototype tests;
(viii) maximum
quantity of contained radioactive material ;
(ix) radiotoxicity of contained radioactive
material ; and
(x) operating
experience with identical sources or devices or similarly designed and
constructed sources or devices.
(11) Requirements for license to manufacture
and distribute industrial products containing depleted uranium for mass-volume
applications.
(a) An application for a
specific license to manufacture industrial products and devices containing
depleted uranium for use pursuant to Subsection
R313-21-21(7)
or equivalent regulations of the Nuclear Regulatory Commission or an Agreement
State will be approved if:
(i) the applicant
satisfies the general requirements specified in Section
R313-22-33;
(ii) the applicant submits sufficient
information relating to the design, manufacture, prototype testing, quality
control procedures, labeling or marking, proposed uses and potential hazards of
the industrial product or device to provide reasonable assurance that
possession, use or transfer of the depleted uranium in the product or device is
not likely to cause an individual to receive a radiation dose more than 10% of
the annual limits specified in Subsection
R313-15-201(1);
and
(iii) the applicant submits
sufficient information regarding the industrial product or device and the
presence of depleted uranium for a mass-volume application in the product or
device to provide reasonable assurance that unique benefits will accrue to the
public because of the usefulness of the product or device.
(b) In the case of an industrial product or
device whose unique benefits are questionable, the director will approve an
application for a specific license under Subsection
R313-22-75(11)
only if the product or device is found to combine a high degree of utility and
low probability of uncontrolled disposal and dispersal of significant
quantities of depleted uranium into the environment.
(c) The director may deny an application for
a specific license under Subsection
R313-22-75(11)
if the end use of the industrial product or device cannot be reasonably
foreseen.
(d) A person licensed
pursuant to Subsection
R313-22-75(11)(a)
shall:
(i) maintain the level of quality
control required by the license in the manufacture of the industrial product or
device, and in the installation of the depleted uranium into the product or
device;
(ii) label or mark each
unit to:
(A) identify the manufacturer of the
product or device and the number of the license where the product or device was
manufactured, the fact that the product or device contains depleted uranium ,
and the quantity of depleted uranium in each product or device; and
(B) state that the receipt, possession, use
and transfer of the product or device are subject to a general license or the
equivalent and the regulations of the Nuclear Regulatory Commission or an
Agreement State ;
(iii)
assure that the uranium before being installed in each product or device has
been impressed with the legend "Depleted Uranium " clearly legible through a
plating or other covering;
(iv)
furnish to each person to whom depleted uranium in a product or device is
transferred for use pursuant to the general license contained in Subsection
R313-21-21(5)
or its equivalent:
(A) a copy of the general
license contained in Subsection
R313-21-21(7)
and a copy of form DWMRC-12; or
(B)
a copy of the general license contained in the Nuclear Regulatory Commission 's
or Agreement State 's regulation equivalent to Subsection
R313-21-21(7)
and a copy of the Nuclear Regulatory Commission 's or Agreement State 's
certificate, or alternatively, furnish a copy of the general license contained
in Subsection R313-21-21(7)
and a copy of form DWMRC-12 with a note explaining that use of the product or
device is regulated by the Nuclear Regulatory Commission or an Agreement State
under requirements substantially equivalent to those in Subsection
R313-21-21(7);
(v) report to the director each
transfer of industrial products or devices to a person for use under the
general license in Subsection
R313-21-21(7).
The report shall identify each general licensee by name and address, an
individual by name or position who may constitute a point of contact between
the director and the general licensee , the type and model number of device
transferred, and the quantity of depleted uranium contained in the product or
device. The report shall be submitted within 30 days after the end of the
calendar quarter when the product or device is transferred to the generally
licensed person . If no transfers have been made to a person generally licensed
under Subsection R313-21-21(7)
during the reporting period, the report shall so state;
(vi) provide certain other reports as
follows:
(A) report to the Nuclear Regulatory
Commission each transfer of industrial products or devices to a person for use
under the Nuclear Regulatory Commission general license in
10 CFR
40.25 (2010);
(B) report to the responsible state agency
each transfer of devices manufactured and distributed pursuant to Subsection
R313-22-75(11)
for use under a general license in that state's regulations equivalent to
Subsection R313-21-21(7);
(C) reports shall identify each general
licensee by name and address, an individual by name or position who may
constitute a point of contact between the agency and the general licensee , the
type and model number of the device transferred, and the quantity of depleted
uranium contained in the product or device. The report shall be submitted
within 30 days after the end of each calendar quarter when a product or device
is transferred to the generally licensed person ;
(D) if no transfers have been made to Nuclear
Regulatory Commission licensees during the reporting period, this information
shall be reported to the Nuclear Regulatory Commission ; and
(E) if no transfers have been made to general
licensees within a particular Agreement State during the reporting period, this
information shall be reported to the responsible Agreement State agency upon
the request of that agency; and
(vii) records shall be kept showing the name,
address and point of contact for each general licensee to whom the person
transfers depleted uranium in industrial products or devices for use pursuant
to the general license provided in Subsection
R313-21-21(7)
or equivalent regulations of the Nuclear Regulatory Commission or an Agreement
State . The records shall be maintained for a period of two years and shall show
the date of each transfer, the quantity of depleted uranium in the product or
device transferred, and compliance with the report requirements of Subsection
R313-22-75(11).
Notes
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.