Fla. Admin. Code Ann. R. 64E-5.206 - General Licenses - Radioactive Material Other Than Source Material
(1) Certain Devices and Equipment. A general
license is hereby issued to transfer, receive, acquire, own, possess and use
radioactive material incorporated in the following devices or equipment which
have been manufactured, tested and labeled by the manufacturer in accordance
with a specific license issued to the manufacturer by the U.S. Nuclear
Regulatory Commission for use pursuant to Section 31.3 of 10 C.F.R. Part 31 .
This general license is subject to the provisions of Rules
64E-5.103 through
64E-5.104, paragraph
64E-5.203(1)(b),
Rules 64E-5.213,
64E-5.215, Part III, Part IX and
Part XV, F.A.C.
(a) Static Elimination
Devices. Devices designed for use as static eliminators which contain, as a
sealed source or sources, radioactive material consisting of a total of not
more than 500 microcuries (18.5 MBq) of polonium 210 per device; and,
(b) Ion Generating Tubes. Devices designed
for ionization of air which contain, as a sealed source or sources, radioactive
material consisting of a total of not more than 500 microcuries (18.5 MBq) of
polonium 210 per device or a total of not more than 50 millicuries (1.85 GBq)
of tritium per device.
(2) Reserved.
(3) Reserved.
(4) Certain Measuring, Gauging and
Controlling Devices.
(a) A general license is
hereby issued to commercial and industrial firms and to research, educational
and medical institutions, individuals in the conduct of their businesses, and
state or local government agencies to own, receive, acquire, possess, use or
transfer in accordance with the provisions of paragraphs (4)(b), (c), and (d),
below, radioactive material, excluding special nuclear material, contained in
devices designed and manufactured for the purpose of detecting, measuring,
gauging or controlling thickness, density, level, interface location,
radiation, leakage, or qualitative or quantitative chemical composition, or for
producing light or an ionized atmosphere.
(b)
1. The
general license in paragraph (4)(a), above, applies only to radioactive
material contained in devices which have been manufactured or initially
transferred and labeled in accordance with the specifications contained in a
specific license issued by the Department pursuant to subsection
64E-5.210(4),
F.A.C., or in accordance with the specifications contained in a specific
license issued by the NRC, or an Agreement State, which authorizes distribution
of devices to persons granted a general license by the NRC, or an Agreement
State. Regulations under the Federal Food, Drug, and Cosmetic Act authorizing
the use of radioactive control devices in food production require certain
additional labeling thereon which is found in
21 C.F.R. Part 179, section
179.21, April 1, 2013 edition, and is herein
incorporated by reference and may be obtained from the internet at
http://www.flrules.org/Gateway/reference.asp?No=Ref-05471
or at
http://www.gpo.gov/fdsys/pkg/CFR-2013-title21-vol3/pdf/CFR-2013-title21-vol3-part179-subpartB.pdf.
2. The devices must have been received from
one of the specific licenses described in subparagraph (b)1., above, or through
a transfer made under subparagraph
64E-5.206(4)(c)
8., F.A.C.
(c) Any person
who owns, receives, acquires, possesses, uses, or transfers radioactive
material in a device pursuant to the general license in paragraph (4)(a),
above;
1. Shall assure that all labels
affixed to the device at the time of receipt, and bearing a statement that
removal of the label is prohibited, are maintained thereon and shall comply
with all instructions and precautions provided by such labels;
2. Shall assure that the device is tested for
leakage of radioactive material and proper operation of the on-off mechanism
and indicator, if any, at no longer than 6-month intervals or at such other
intervals as are specified in the label. However,
a. Devices containing only krypton need not
be tested for leakage of radioactive material; and,
b. Devices containing only tritium or not
more than 100 microcuries (3.7 MBq) of other beta- and/or gamma-emitting
material or 10 microcuries (0.37 MBq) of alpha-emitting material and devices
held in storage in the original shipping container prior to initial
installation need not be tested for any purpose,
3. Shall assure that other testing,
installation, servicing and removal from installation involving the radioactive
material, its shielding or containment, are performed:
a. In accordance with the instructions
provided by the labels, or
b. By a
person holding an applicable specific license from the Department, the U.S.
Nuclear Regulatory Commission, an Agreement State or a Licensing State to
perform such activities,
4. Shall maintain records showing compliance
with the requirements of subparagraphs (4)(c)2. and 3., above. The records
shall show the results of tests. The records also shall show the dates of
performance of, and the names of persons performing testing, installation,
servicing and removal from installation concerning the radioactive material,
its shielding or containment. Records of tests for leakage of radioactive
material required by subparagraph (4)(c)2., above, shall be maintained for at
least three years after the next required leak test is performed or until the
transfer or disposal of the sealed source. Records of tests of the on-off
mechanism and indicator required by subparagraph (4)(c)2., above, shall be
maintained for at least three years after the next required test of the on-off
mechanism and indicator is performed or until the sealed source is transferred
or disposed. Records which are required by subparagraph (4)(c)3., above, shall
be maintained for a period of at least 3 years from the date of the recorded
event or until the transfer or disposal of the device.
5. Upon the occurrence of a failure of or
damage to, or any indication of a possible failure of or damage to, the
shielding of the radioactive material or the on-off mechanism or indicator, or
upon the detection of 0.005 microcurie (185 Bq) or more removable radioactive
material, shall immediately suspend operation of the device until it has been
repaired by the manufacturer or other person holding an applicable specific
license from the Department, the U.S. Nuclear Regulatory Commission, an
Agreement State or a Licensing State to repair such devices, or disposed of by
transfer to a person authorized by an applicable specific license to receive
the radioactive material contained in the device and, within 30 days, furnish
to the Department a report containing a brief description of the event and the
remedial action taken; and in the case of removable radioactive materials or
failure of or damage to a source likely to result in contamination of the
premises or the environment, a plan for ensuring the premises and environment
are acceptable for unrestricted use using the criteria described in Rule
64E-5.222, F.A.C.
6. Shall not abandon the device containing
radioactive material.
7. Except as
provided in subparagraph (4)(c)8., below, shall transfer or dispose of the
device containing radioactive material only by export as provided by
subparagraph 15. below, transfer to a specific licensee of the Department, the
NRC, or an Agreement State, whose specific license authorizes him to receive
the device, and within 30 days after transfer of a device to a specific
licensee or export, shall furnish to the Department a report containing
identification of the device by manufacturer's or initial transferor's name and
model number and serial number, the name, address, license number, where
applicable, of the person receiving the device, and the date of the
transfer.
8. Shall transfer the
device by export as provided by paragraph 15 below, or to another general
licensee only:
a. Where the device remains in
use at a particular location. In such case the transferor shall give the
transferee a copy of this section, a copy of Rules 64E-5.103,
64E-5.343, and
64E-5.344, F.A.C., and any
safety documents identified in the label on the device and within 30 days of
the transfer, report to the Department the manufacturer's or initial
transferor's name and model number and serial number of device transferred, the
transferor's name and mailing address for the location of use, and the name,
title and phone number of the responsible individual identified by the
transferee in accordance with subparagraph
64E-5.206(4)(c)
11., F.A.C., to have knowledge of and authority to take actions to ensure
compliance with these regulations, or
b. Where the device is held in storage in the
original shipping container at its intended location of use prior to initial
use by a general licensee; and,
9. Shall comply with the provisions of Rules
64E-5.343 and 64E-5.344, F.A.C.,
for reporting radiation incidents, theft or loss of licensed material, but
shall be exempt from the other requirements of Parts III and IX.
10. Shall be required to obtain written
Department authorization before transferring the device to any other specific
license not specifically identified in subparagraph
64E-5.206(4)(c)
7., F.A.C. A holder of a specific license may transfer a device for possession
and use under its own specific license without prior approval if the specific
license holder satisfies the following requirements:
a. Verifies that the specific license
authorizes the possession and use, or applies for and obtains an amendment to
the license authorizing the possession and use,
b. Removes, alters, covers, or clearly and
unambiguously augments the existing label otherwise required by subparagraph
64E-5.206(4)(c)
1., F.A.C., so that the device is labeled in compliance with Rule
64E-5.325, F.A.C., provided the
manufacturer, model number, and serial number is retained,
c. Obtains manufacturer's or initial
transferor's information concerning maintenance that would be applicable under
the specific license such as leak testing procedures,
d. Reports the transfer under subparagraph
64E-5.206(4)(c)
7., F.A.C.
11. Shall
appoint an individual responsible for having knowledge of the appropriate
regulations and requirements and the authority for taking required actions to
comply with appropriate regulations and requirements. The general licensee,
through this individual, shall ensure the day-to-day compliance with the
appropriate regulations and requirements. This appointment does not relieve the
general licensee of any of its responsibility in the regard.
12.
a.
Shall register, in accordance with sub-subparagraphs
64E-5.206(4)(c)
12.b. and 64E-5.206(4)(c)
12.c., F.A.C., all devices except exit signs containing tritium. Each address
for a location of use as described in sub-sub-subparagraph
64E-5.206(4)(c)
12.c.(IV), F.A.C., represents a separate general license and requires a
separate registration.
b. Shall
annually register with the Department the possession of a device meeting the
criteria in sub-subparagraph
64E-5.206(4)(c)
12.a., F.A.C. Registration must be done by verifying, correcting or adding to
the information provided in a request for registration received from the
Department. The registration information must be submitted to the Department
within 30 days of the date of the request for registration or as otherwise
indicated in the request. In addition, the general licensee holding devices
that meet the criteria of sub-subparagraph
64E-5.206(4)(c)
12.a., F.A.C., is subject to the bankruptcy notification requirements in
subsection 64E-5.213(3),
F.A.C.
c. Shall provide the
following information and any other information requested by the Department:
(I) Name and mailing address of the general
licensee,
(II) For each device, the
manufacturer's name or initial transferor name, model number, serial number,
the radioisotope and activity as identified on the label,
(III) Name, title, and telephone number of
the responsible person designated a representative of the general licensee
under subparagraph 64E-5.206(4)(c)
11., F.A.C.,
(IV) Address or
location at which the device(s) are used or stored. For portable devices, the
address of the primary place of storage,
(V) Certification by the responsible
representative of the general licensee that the information concerning the
devices(s) has been verified through a physical inventory and checking the
label information; and,
(VI)
Certification by the responsible representative of the general licensee that
they are aware of the requirements of the general license.
d. Persons generally licensed by other
Agreement States, Licensing States, or the U.S. Nuclear Regulatory Commission
with respect to devices meeting the criteria in
10 CFR
31.5(c)(13)(i) are not
subject to registration requirements if the devices are used in areas subject
to the Department jurisdiction for less than 180 days in any calendar year. The
Department will not request registration from such
licensees.
13. Shall
report to the Department changes in the general licensee name and the mailing
address for each location of use within 30 days of the effective date of the
change. For a portable device, a report of address change is required for a
change in the device's primary place of storage.
14. Shall not hold devices that are not in
use longer than 2 years. If the devices with shutters are not being used, the
shutters must be locked in the closed position. The testing required by
subparagraph 64E-5.206(4)(c)
2., F.A.C., need not be performed during the period of storage only. However,
when devices are put back into service or transferred to another person, and
have not been tested within the required test interval, they must be tested for
leakage before use or transfer and the shutter trested before use. Devices kept
in standby for future use are excluded from the two year time limit if the
general licensee performs physical inventories at intervals not to exceed three
months while they are in standby.
15. Shall not export the device containing
radioactive material except in accordance with 10 C.F.R. Part 110.
16. Shall respond to written requests from
the Department to provide information relating to the general license within 30
calendar days of the date of the request, or other time specified in the
request. If the general licensee cannot provide the requested information
within the allotted time, it shall, within that same time period, request a
longer period to supply the information by providing the Department, a written
justification for the request for extension of time.
(d) The general license in paragraph (4)(a),
above, does not authorize the manufacture of devices containing radioactive
material.
(5) Luminous
Safety Devices for Aircraft.
(a) A general
license is hereby issued to own, receive, acquire, possess and use tritium or
promethium 147 contained in luminous safety devices for use in aircraft,
provided:
1. Each device contains not more
than 10 curies (370 GBq) of tritium or 300 millicuries (11.1 GBq) of promethium
147; and.
2. Each device has been
manufactured, assembled or imported in accordance with a specific license
issued by the U.S. Nuclear Regulatory Commission, or each device has been
manufactured or assembled in accordance with the specifications contained in a
specific license issued by the Department or any Agreement State to the
manufacturer or assembler of such device pursuant to licensing requirements
equivalent to those in Section 32.53 of 10 C.F.R. Part 32.
(b) Persons who own, receive, acquire,
possess or use luminous safety devices pursuant to the general license in
paragraph (5)(a), above, are exempt from the requirements of Parts III and IX
except that they shall comply with the provisions of Rules 64E-5.343 and
64E-5.344, F.A.C.
(c) This general
license does not authorize the manufacture, assembly or repair of luminous
safety devices containing tritium or promethium 147.
(d) This general license does not authorize
the ownership, receipt, acquisition, possession or use of promethium 147
contained in instrument dials.
(e)
This general license is subject to the provisions of Rules
64E-5.103 through 64E-5.104,
64E-5.213, 64E-5.215, and Part XV, F.A.C.
(6) Calibration and Reference Sources.
(a) A general license is hereby issued to
those persons listed below to own, receive, acquire, possess, use and transfer,
in accordance with the provisions of paragraphs (6)(d) and (e), below,
americium 241 in the form of calibration or reference sources:
1. Any person who holds a specific license
issued by the Department which authorizes him to receive, possess, use and
transfer radioactive material; and.
2. Any person who holds a specific license
issued by the U.S. Nuclear Regulatory Commission which authorizes him to
receive, possess, use and transfer special nuclear
material.
(b) A general
license is hereby issued to own, receive, possess, use and transfer plutonium
in the form of calibration or reference sources in accordance with the
provisions of paragraphs (6)(d) and (e), below, to any person who holds a
specific license issued by the Department which authorizes him to receive,
possess, use and transfer radioactive material.
(c) A general license is hereby issued to
own, receive, possess, use and transfer radium 226 in the form of calibration
or reference sources in accordance with the provisions of paragraphs (6)(d) and
(e), below, to any person who holds a specific license issued by the Department
which authorizes him to receive, possess, use and transfer radioactive
material.
(d) The general licenses
in paragraph (6)(a), (b) and (c), above, apply only to calibration or reference
sources which have been manufactured in accordance with the specifications
contained in a specific license issued to the manufacturer or importer of the
sources by the U.S. Nuclear Regulatory Commission pursuant to Section 32.57 of
10 C.F.R. Part 32 or Section 70.39 of 10 C.F.R. Part 70 or which have been
manufactured in accordance with the specifications contained in a specific
license issued to the manufacturer by the Department, an Agreement State or
Licensing State pursuant to licensing requirements equivalent to those
contained in Section 32.57 of 10 C.F.R. Part 32 or Section 70.39 of 10 C.F.R.
Part 70.
(e) The general licenses
provided in paragraphs (6)(a), (b) and (c), above, are subject to the
provisions of Rules 64E-5.103 through 64E-5.104,
64E-5.213, 64E-5.215, Parts III, IX and XV, F.A.C. In addition, persons who
own, receive, acquire, possess, use or transfer one or more calibration or
reference sources pursuant to these general licenses:
1. Shall not possess at any given time, at
any single location of storage or use, more than 5 microcuries (185 kBq) of
americium 241, 5 microcuries (185 kBq) of plutonium, or 5 microcuries (185 kBq)
of radium 226 in such sources,
2.
Shall not receive, possess, use or transfer such source unless the source, or
the storage container, bears a label which includes one of the following
statements, as appropriate, or a substantially similar statement which contains
the information called for in one of the following statements, as appropriate:
a. The receipt, possession, use and transfer
of this source, model ___, serial no. ___, are subject to a general license and
the regulations 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. Do not remove this label.
CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS (AMERICIUM 241) (PLUTONIUM). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
____________________________
Name of manufacturer or importer
b. The receipt, possession, use and transfer
of this source, model ___, serial no. ___, are subject to a general license and
the regulations of a Licensing State. Do not remove this label.
CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS RADIUM 226. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
____________________________
Name of manufacturer or importer
3. Shall not transfer, abandon or dispose of
such source except by transfer to a person authorized by a license from the
Department, the U.S. Nuclear Regulatory Commission, an Agreement State or a
Licensing State to receive the source,
4. Shall store such source, except when the
source is being used, in a closed container adequately designed and constructed
to contain americium 241, plutonium or radium 226, which might otherwise escape
during storage; and,
5. Shall not
use such source for any purpose other than the calibration of radiation
detectors or the standardization of other sources.
(f) These general licenses do not authorize
the manufacture of calibration or reference sources containing americium 241,
plutonium or radium 226.
(7) Medical Diagnostic Uses.
(a) A general license shall be issued to any
physician to receive, possess, transfer or use radioactive material set forth
below for the stated diagnostic uses, provided, however, that the use is in
accordance with the provision of paragraphs (7)(b), (c), and (d), below, the
radioactive material is in the form of capsules, disposable syringes or other
prepackaged individual doses; and the radioactive material has been
manufactured in accordance with a specific license issued by the Department
pursuant to subsection
64E-5.210(7),
F.A.C., or by the U.S. Nuclear Regulatory Commission, an Agreement State or a
Licensing State pursuant to equivalent regulations authorizing distribution to
persons under a general license pursuant to this subsection or its equivalent:
1. Chromium 51 as sodium radiochromate for
determination of red blood cell volumes and studies of red blood cell survival
time,
2. Cobalt 57 for the
measurement of intestinal absorption of cyanocobalamin,
3. Cobalt 58 for the measurement of
intestinal absorption of cyanocobalamin,
4. Cobalt 60 for the measurement of
intestinal absorption of cyanocobalamin,
5. Iodine 125 as iodinated human serum
albumin (IHSA) for determinations of blood and blood plasma volume,
6. Iodine 131 as sodium iodide for
measurement of thyroid uptake; and,
7. Iodine 131 as iodinated human serum
albumin (IHSA) for determinations of blood and blood plasma
volume.
(b) No physician
shall receive, possess, use or transfer radioactive material pursuant to the
general license established by paragraph (7)(a), above, until he has submitted
the original and one copy of the completed form DH 361, 10/12 and received from
the Department a validated copy of this form with a certification number
assigned. DH 361 10/12, entitled, "Certificate - Medical Use of Radioactive
Material under General License, " is herein incorporated by reference and can
be obtained from the internet at
http://www.flrules.org/Gateway/reference.asp?No=Ref-03450,
or at http://www.doh.state.fl.us/environment/radiation/matform.htm.
(c) A physician who receives, possesses or
uses a pharmaceutical containing radioactive material pursuant to the general
license established by paragraph (7)(a), above, shall comply with the
following:
1. The physician shall not possess
at any given time, pursuant to the general license in paragraph (7)(a), above,
more than:
a. Two hundred microcuries (7.4
MBq) of iodine 131,
b. Two hundred
microcuries (7.4 MBq) of iodine 125,
c. Five microcuries (185 kBq) of cobalt 57,
d. Five microcuries (185 kBq) of
cobalt 58,
e. Five microcuries (185
kBq) of cobalt 60,
f. Two hundred
microcuries (7.4 MBq) of chromium 51;
2. The physician shall store the
pharmaceutical in the original shipping container until administered, or in a
container providing equivalent radiation protection,
3. The physician shall use the pharmaceutical
only for the uses authorized by paragraph (7)(a), above,
4. The physician shall not transfer the
radioactive material to a person who is not authorized to receive it pursuant
to a license issued by the Department, the U.S. Nuclear Regulatory Commission,
an Agreement State or Licensing State, or in any manner other than in the
unopened, labeled shipping container as received from the supplier, except by
administering it to a patient.
(d) The general licensed physician possessing
or using radioactive material under the general license of paragraph (7)(a),
above, shall report in duplicate to the Department any changes in the
information furnished by him on Form 361. The report shall be submitted within
30 days after the effective date of such change.
(e) Any person using radioactive material
pursuant to the general license of paragraph (7)(a), above, is exempt from the
requirements of Parts III and IX with respect to the radioactive material
covered by the general license.
(f)
Manufacturers of radiopharmaceuticals which are under the general license in
this subsection are required to affix a certain identifying label to the
container, and in the leaflet or brochure which accompanies the
radiopharmaceutical, pursuant to subsection
64E-5.210(7),
F.A.C.
(8) General
License for Use of Radioactive Material for Certain In Vitro
Clinical or Laboratory Testing.
(a) A general
license is hereby issued to any physician, veterinarian, clinical laboratory or
hospital to receive, acquire, possess, transfer or use, for any of the
following stated tests, in accordance with the provisions of paragraphs (8)(b),
(c), (d), (e) and (f), below, the following radioactive materials in
prepackaged units for use in in vitro clinical or laboratory
tests not involving internal or external administration of radioactive
material, or the radiation therefrom, to human beings or animals:
1. Carbon 14, in units not exceeding 10
microcuries (370 kBq) each.
2.
Cobalt 57, in units not exceeding 10 microcuries (370 kBq) each.
3. Hydrogen 3 (tritium), in units not
exceeding 50 microcuries (1.85 MBq) each.
4. Iodine 125, in units not exceeding 10
microcuries (370 kBq) each.
5. Mock
Iodine 125 reference or calibration sources, in units not exceeding 0.05
microcuries (1.85 kBq) of iodine 129 and 0.005 microcuries (0.185 kBq) of
americium 241 each.
6. Iodine 131,
in units not exceeding 10 microcuries (370 kBq) each.
7. Iron 59, in units not exceeding 20
microcuries (740 kBq) each.
8.
Selenium 75, in units not exceeding 10 microcuries (370 kBq)
each.
(b) No person shall
receive, acquire, possess, use or transfer radioactive material pursuant to the
general license established by paragraph (8)(a), above, until he has submitted
the original and one copy of the completed form DH 360 10/12, and received from
the Department a validated copy of this form with a certification number
assigned. DH 360 10/12 entitled, "Certificate - In Vitro
Testing with Radioactive Material under General License" is herein incorporated
by reference and can be obtained from the internet at
http://www.flrules.org/Gateway/reference.asp?No=Ref-03451,
or at http://www.doh.state.fl.us/environment/radiation/matform.htm.
(c) A person who receives, acquires,
possesses or uses radioactive material pursuant to the general license
established by paragraph (8)(a), above, shall comply with the following:
1. The general licensee shall not possess at
any given time, pursuant to the general license in paragraph (8)(a), above, at
any single location of storage or use, a combined total amount of iodine 125,
iodine 131, selenium 75, iron 59 or cobalt 57 in excess of 200 microcuries (7.4
MBq).
2. The general licensee shall
store the radioactive material, until used, in the original shipping container
or in a container providing equivalent radiation protection.
3. The general licensee shall use the
radioactive material only for the uses authorized by paragraph (8)(a),
above.
4. The general licensee
shall not transfer the radioactive material to a person who is not authorized
to receive it pursuant to a license issued by the Department, the U.S. Nuclear
Regulatory Commission, an Agreement State or Licensing State, nor transfer the
radioactive material in any manner other than in the unopened, labeled shipping
container as received from the supplier.
5. The general licensee shall dispose of the
mock iodine 125 reference or calibration sources described in paragraph (8)(a),
above, as required by Rule
64E-5.328,
F.A.C.
(d) The general
licensee shall not receive, acquire, possess or use radioactive material
pursuant to paragraph (8)(a), above:
1. Except
as prepackaged units which are labeled in accordance with the provisions of an
applicable specific license issued pursuant to subsection
64E-5.210(8),
F.A.C., or in accordance with the provisions of a specific license issued by
the U.S. Nuclear Regulatory Commission, an Agreement State or Licensing State
which authorizes the manufacture and distribution of iodine 125, iodine 131,
carbon 14, hydrogen 3 (tritium), iron 59, selenium 75, cobalt 57 or mock iodine
125 to persons under a general license described in this subsection or its
equivalent; and,
2. Unless one of
the following statements, as appropriate or a substantially similar statement
which contains the information called for in one of the following statements,
appears on a label affixed to each prepackaged unit or appears in a leaflet or
brochure which accompanies the package:
a.
This radioactive material shall be received, acquired, possessed and used only
by physicians, veterinarians, clinical laboratories or hospitals and only for
in in vitro clinical or laboratory tests not involving
internal or external administration of the material, or the radiation
therefrom, to human beings or animals. Its receipt, acquisition, possession,
use and transfer are subject to the regulations and a general license of the
U.S. Nuclear Regulatory Commission or of a state with which the U.S. Nuclear
Regulatory Commission has entered into an agreement for the exercise of
regulatory authority.
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__________________ |
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Name of manufacturer |
b.
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.
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__________________ |
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Name of manufacturer |
(e) The physician, veterinarian, clinical
laboratory or hospital possessing or using radioactive material under the
general license of paragraph (8)(a), above, shall report in writing to the
Department any changes in the information furnished by him in the "Certificate
- In Vitro Testing with Radioactive Material Under General
License". The report shall be furnished within 30 days after the effective date
of such change.
(f) Any person
using radioactive material pursuant to the general license of paragraph (8)(a),
above, is exempt from the requirements of Parts III and IX with respect to
radioactive material covered by that general license, except that such persons
using the mock iodine 125 described in subparagraph (8)(a)5., above, shall
comply with the provisions of Rules 64E-5.328,
64E-5.343, and
64E-5.344, F.A.C.
(g) The New Drug provisions of the Federal
Food, Drug and Cosmetic Act also govern the availability and use of any
specific diagnostic drugs in interstate commerce.
(9) Ice Detection Devices.
(a) A general license is hereby issued to
own, receive, acquire, possess, use and transfer strontium 90 contained in ice
detection devices, provided each device contains not more than 50 microcuries
(1.85 MBq) of strontium 90 and each device has been manufactured or imported in
accordance with a specific license issued by the U.S. Nuclear Regulatory
Commission or each device has been manufactured in accordance with the
specifications contained in a specific license issued by the Department or an
Agreement State to the manufacturer of such device pursuant to licensing
requirements equivalent to those in Section 32.61 of 10 C.F.R. Part
32.
(b) Persons who own, receive,
acquire, possess, use or transfer strontium 90 contained in ice detection
devices pursuant to the general license in paragraph (9)(a), above:
1. Shall, upon occurrence of visually
observable damage, such as a bend or crack or discoloration from overheating to
the device, discontinue use of the device until it has been inspected, tested
for leakage and repaired by a person holding a specific license from the U.S.
Nuclear Regulatory Commission or an Agreement State to manufacture or service
such devices; or shall dispose of the device pursuant to the provisions of Rule
64E-5.328, F.A.C.;
2. Shall assure
that all labels affixed to the device at the time of receipt, and which bear a
statement which prohibits removal of the labels, are maintained thereon; and,
(c) This general
license does not authorize the manufacture, assembly, disassembly or repair of
strontium 90 in ice detection devices.
(10) Ownership of
Radioactive Material. A general license is hereby issued to own radioactive
material without regard to quantity. Notwithstanding any other provisions of
this part, this general license does not authorize the manufacture, production,
transfer, receipt, possession or use of radioactive material.
(11) Certain Items and Self-Luminous Products
Containing Radium-226.
(a) A general license
is hereby issued to any person to acquire, receive, possess, use, or transfer,
in accordance with the provisions of subsections
64E-5.206(11)(b), (c), and
(d), F.A.C., radium-226 contained in the
following products manufactured prior to November 30, 2007.
1. Antiquities originally intended for use by
the general public. For the purposes of this paragraph, antiquities mean
products originally intended for use by the general public and distributed in
the late 19th and early 20th centuries, such as radium emanatory jars,
revigators, radium water jars, radon generators, refrigerator cards, radium
bath salts, and healing pads.
2.
Intact timepieces containing greater than 0.037 megabecquerel (1 microcurie),
nonintact timepieces, and timepiece hands and dials no longer installed in
timepieces.
3. Luminous items
installed in air, marine, or land vehicles.
4. All other luminous products, provided that
no more than 100 items are used or stored at the same location at any one
time.
5. Small radium sources
containing no more than 0.037 megabecquerel (1 microcurie) of radium-226. For
the purposes of this paragraph, ''small radium sources'' means discrete survey
instrument check sources, sources contained in radiation measuring instruments,
sources used in educational demonstrations (such as cloud chambers and
spinthariscopes), electron tubes, lightning rods, ionization sources, static
eliminators, or as designated by the NRC.
(b) Persons who acquire, receive, possess,
use, or transfer byproduct material under the general license issued in
paragraph 64E-5.206(11)(a),
F.A.C., of this section are exempt from the provisions of Parts III and IX, to
the extent that the receipt, possession, use, or transfer of radioactive
materials is within the terms of the general license. This exemption shall not
apply to any such person specifically licensed under Chapter 64E-5,
F.A.C.
(c) Any person who acquires,
receives, possesses, uses, or transfers byproduct material in accordance with
the general license in subsection
64E-5.206(11)(a),
F.A.C., must also comply with the following requirements:
1. Shall notify the Department should there
be any indication of possible damage to the product so that it appears it could
result in a loss of the radioactive material. A report containing a brief
description of the event, and the remedial action taken, must be furnished to
the Department within 30 days,
2.
Shall not abandon products containing radium-226. The product, and any
radioactive material from the product, may only be disposed of according to
Rule 64E-5.328, F.A.C., or by
transfer to a person authorized by a specific license to receive the radium-226
in the product or as otherwise approved by the Department,
3. Shall not export products containing
radium-226 except in accordance with 10 C.F. R. Part 110, 1-1-14 edition which
is herein incorporated by reference and can be obtained from the internet at
http://www.flrules.org/Gateway/reference.asp?No=Ref-05472,
or at
http://www.gpo.gov/fdsys/pkg/CFR-2014-title10-vol2/pdf/CFR-2014-title10-vol2-part110.pdf,
4. Shall dispose of products
containing radium-226 at a disposal facility authorized to dispose of
radioactive material in accordance with any Federal or State solid or hazardous
waste law, including the Solid Waste Disposal Act, as authorized under the
Energy Policy Act of 2005, by transfer to a person authorized to receive
radium-226 by a specific license issued under Part III, or equivalent
regulations of an Agreement State or the NRC, as otherwise approved by the
Department.
5. Shall respond to
written requests from the Department to provide information relating to the
general license within 30 calendar days of the date of the request, or other
time specified in the request. If the general licensee cannot provide the
requested information within the allotted time, it shall, within that same time
period, request a longer period to supply the information by providing the
Department a written justification for the request.
(d) Except for disassembly and repair of
timepieces described in subparagraph
64E-5.206(11)(a)
2., F.A.C., the general license in paragraph
64E-5.206(11)(a),
F.A.C., does not authorize the manufacture, assembly, disassembly, repair, or
import of products containing radium-226.
Notes
Rulemaking Authority 404.051, 404.061, 404.071 FS. Law Implemented 404.051(1), (4), (6), (8), (9), (10), (11), 404.061(2), 404.071(1), (3), 404.081(1), 404.141 FS.
New 7-17-85, Amended 4-4-89, 1-1-94, Formerly 10D-91.306, Amended 9-28-06, 2-28-08, 12-26-13, 7-1-15.
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.
(1) Certain Devices and Equipment. A general license is hereby issued to transfer, receive, acquire, own, possess and use radioactive material incorporated in the following devices or equipment which have been manufactured, tested and labeled by the manufacturer in accordance with a specific license issued to the manufacturer by the U.S. Nuclear Regulatory Commission for use pursuant to Section 31.3 of 10 C.F.R. Part 31 . This general license is subject to the provisions of Rules 64E-5.103 through 64E-5.104, paragraph 64E-5.203(1)(b), Rules 64E-5.213, 64E-5.215, Part III, Part IX and Part XV, F.A.C.
(a) Static Elimination Devices. Devices designed for use as static eliminators which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 microcuries (18.5 MBq) of polonium 210 per device; and,
(b) Ion Generating Tubes. Devices designed for ionization of air which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 microcuries (18.5 MBq) of polonium 210 per device or a total of not more than 50 millicuries (1.85 GBq) of tritium per device.
(2) Reserved.
(3) Reserved.
(4) Certain Measuring, Gauging and Controlling Devices.
(a) A general license is hereby issued to commercial and industrial firms and to research, educational and medical institutions, individuals in the conduct of their businesses, and state or local government agencies to own, receive, acquire, possess, use or transfer in accordance with the provisions of paragraphs (4)(b), (c), and (d), below, radioactive material, excluding special nuclear material, contained in devices designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, level, interface location, radiation, leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere.
(b)
1. The general license in paragraph (4)(a), above, applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued by the Department pursuant to subsection 64E-5.210(4), F.A.C., or in accordance with the specifications contained in a specific license issued by the NRC, or an Agreement State, which authorizes distribution of devices to persons granted a general license by the NRC, or an Agreement State. Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling thereon which is found in 21 C.F.R. Part 179, section 179.21, April 1, 2013 edition, and is herein incorporated by reference and may be obtained from the internet at http://www.flrules.org/Gateway/reference.asp?No=Ref-05471 or at http://www.gpo.gov/fdsys/pkg/CFR-2013-title21-vol3/pdf/CFR-2013-title21-vol3-part179-subpartB.pdf.
2. The devices must have been received from one of the specific licenses described in subparagraph (b)1., above, or through a transfer made under subparagraph 64E-5.206(4)(c) 8., F.A.C.
(c) Any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general license in paragraph (4)(a), above;
1. Shall assure that all labels affixed to the device at the time of receipt, and bearing a statement that removal of the label is prohibited, are maintained thereon and shall comply with all instructions and precautions provided by such labels;
2. Shall assure that the device is tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at no longer than 6-month intervals or at such other intervals as are specified in the label. However,
a. Devices containing only krypton need not be tested for leakage of radioactive material; and,
b. Devices containing only tritium or not more than 100 microcuries (3.7 MBq) of other beta- and/or gamma-emitting material or 10 microcuries (0.37 MBq) of alpha-emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose,
3. Shall assure that other testing, installation, servicing and removal from installation involving the radioactive material, its shielding or containment, are performed:
a. In accordance with the instructions provided by the labels, or
b. By a person holding an applicable specific license from the Department, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to perform such activities,
4. Shall maintain records showing compliance with the requirements of subparagraphs (4)(c)2. and 3., above. The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing testing, installation, servicing and removal from installation concerning the radioactive material, its shielding or containment. Records of tests for leakage of radioactive material required by subparagraph (4)(c)2., above, shall be maintained for at least three years after the next required leak test is performed or until the transfer or disposal of the sealed source. Records of tests of the on-off mechanism and indicator required by subparagraph (4)(c)2., above, shall be maintained for at least three years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed. Records which are required by subparagraph (4)(c)3., above, shall be maintained for a period of at least 3 years from the date of the recorded event or until the transfer or disposal of the device.
5. Upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 0.005 microcurie (185 Bq) or more removable radioactive material, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding an applicable specific license from the Department, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to repair such devices, or disposed of by transfer to a person authorized by an applicable specific license to receive the radioactive material contained in the device and, within 30 days, furnish to the Department a report containing a brief description of the event and the remedial action taken; and in the case of removable radioactive materials or failure of or damage to a source likely to result in contamination of the premises or the environment, a plan for ensuring the premises and environment are acceptable for unrestricted use using the criteria described in Rule 64E-5.222, F.A.C.
6. Shall not abandon the device containing radioactive material.
7. Except as provided in subparagraph (4)(c)8., below, shall transfer or dispose of the device containing radioactive material only by export as provided by subparagraph 15. below, transfer to a specific licensee of the Department, the NRC, or an Agreement State, whose specific license authorizes him to receive the device, and within 30 days after transfer of a device to a specific licensee or export, shall furnish to the Department a report containing identification of the device by manufacturer's or initial transferor's name and model number and serial number, the name, address, license number, where applicable, of the person receiving the device, and the date of the transfer.
8. Shall transfer the device by export as provided by paragraph 15 below, or to another general licensee only:
a. Where the device remains in use at a particular location. In such case the transferor shall give the transferee a copy of this section, a copy of Rules 64E-5.103, 64E-5.343, and 64E-5.344, F.A.C., and any safety documents identified in the label on the device and within 30 days of the transfer, report to the Department the manufacturer's or initial transferor's name and model number and serial number of device transferred, the transferor's name and mailing address for the location of use, and the name, title and phone number of the responsible individual identified by the transferee in accordance with subparagraph 64E-5.206(4)(c) 11., F.A.C., to have knowledge of and authority to take actions to ensure compliance with these regulations, or
b. Where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general licensee; and,
9. Shall comply with the provisions of Rules 64E-5.343 and 64E-5.344, F.A.C., for reporting radiation incidents, theft or loss of licensed material, but shall be exempt from the other requirements of Parts III and IX.
10. Shall be required to obtain written Department authorization before transferring the device to any other specific license not specifically identified in subparagraph 64E-5.206(4)(c) 7., F.A.C. A holder of a specific license may transfer a device for possession and use under its own specific license without prior approval if the specific license holder satisfies the following requirements:
a. Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use,
b. Removes, alters, covers, or clearly and unambiguously augments the existing label otherwise required by subparagraph 64E-5.206(4)(c) 1., F.A.C., so that the device is labeled in compliance with Rule 64E-5.325, F.A.C., provided the manufacturer, model number, and serial number is retained,
c. Obtains manufacturer's or initial transferor's information concerning maintenance that would be applicable under the specific license such as leak testing procedures,
d. Reports the transfer under subparagraph 64E-5.206(4)(c) 7., F.A.C.
11. Shall appoint an individual responsible for having knowledge of the appropriate regulations and requirements and the authority for taking required actions to comply with appropriate regulations and requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with the appropriate regulations and requirements. This appointment does not relieve the general licensee of any of its responsibility in the regard.
12.
a. Shall register, in accordance with sub-subparagraphs 64E-5.206(4)(c) 12.b. and 64E-5.206(4)(c) 12.c., F.A.C., all devices except exit signs containing tritium. Each address for a location of use as described in sub-sub-subparagraph 64E-5.206(4)(c) 12.c.(IV), F.A.C., represents a separate general license and requires a separate registration.
b. Shall annually register with the Department the possession of a device meeting the criteria in sub-subparagraph 64E-5.206(4)(c) 12.a., F.A.C. Registration must be done by verifying, correcting or adding to the information provided in a request for registration received from the Department. The registration information must be submitted to the Department within 30 days of the date of the request for registration or as otherwise indicated in the request. In addition, the general licensee holding devices that meet the criteria of sub-subparagraph 64E-5.206(4)(c) 12.a., F.A.C., is subject to the bankruptcy notification requirements in subsection 64E-5.213(3), F.A.C.
c. Shall provide the following information and any other information requested by the Department:
(I) Name and mailing address of the general licensee,
(II) For each device, the manufacturer's name or initial transferor name, model number, serial number, the radioisotope and activity as identified on the label,
(III) Name, title, and telephone number of the responsible person designated a representative of the general licensee under subparagraph 64E-5.206(4)(c) 11., F.A.C.,
(IV) Address or location at which the device(s) are used or stored. For portable devices, the address of the primary place of storage,
(V) Certification by the responsible representative of the general licensee that the information concerning the devices(s) has been verified through a physical inventory and checking the label information; and,
(VI) Certification by the responsible representative of the general licensee that they are aware of the requirements of the general license.
d. Persons generally licensed by other Agreement States, Licensing States, or the U.S. Nuclear Regulatory Commission with respect to devices meeting the criteria in 10 CFR 31.5(c)(13)(i) are not subject to registration requirements if the devices are used in areas subject to the Department jurisdiction for less than 180 days in any calendar year. The Department will not request registration from such licensees.
13. Shall report to the Department changes in the general licensee name and the mailing address for each location of use within 30 days of the effective date of the change. For a portable device, a report of address change is required for a change in the device's primary place of storage.
14. Shall not hold devices that are not in use longer than 2 years. If the devices with shutters are not being used, the shutters must be locked in the closed position. The testing required by subparagraph 64E-5.206(4)(c) 2., F.A.C., need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter trested before use. Devices kept in standby for future use are excluded from the two year time limit if the general licensee performs physical inventories at intervals not to exceed three months while they are in standby.
15. Shall not export the device containing radioactive material except in accordance with 10 C.F.R. Part 110.
16. Shall respond to written requests from the Department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Department, a written justification for the request for extension of time.
(d) The general license in paragraph (4)(a), above, does not authorize the manufacture of devices containing radioactive material.
(5) Luminous Safety Devices for Aircraft.
(a) A general license is hereby issued to own, receive, acquire, possess and use tritium or promethium 147 contained in luminous safety devices for use in aircraft, provided:
1. Each device contains not more than 10 curies (370 GBq) of tritium or 300 millicuries (11.1 GBq) of promethium 147; and.
2. Each device has been manufactured, assembled or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, or each device has been manufactured or assembled in accordance with the specifications contained in a specific license issued by the Department or any Agreement State to the manufacturer or assembler of such device pursuant to licensing requirements equivalent to those in Section 32.53 of 10 C.F.R. Part 32.
(b) Persons who own, receive, acquire, possess or use luminous safety devices pursuant to the general license in paragraph (5)(a), above, are exempt from the requirements of Parts III and IX except that they shall comply with the provisions of Rules 64E-5.343 and 64E-5.344, F.A.C.
(c) This general license does not authorize the manufacture, assembly or repair of luminous safety devices containing tritium or promethium 147.
(d) This general license does not authorize the ownership, receipt, acquisition, possession or use of promethium 147 contained in instrument dials.
(e) This general license is subject to the provisions of Rules 64E-5.103 through 64E-5.104, 64E-5.213, 64E-5.215, and Part XV, F.A.C.
(6) Calibration and Reference Sources.
(a) A general license is hereby issued to those persons listed below to own, receive, acquire, possess, use and transfer, in accordance with the provisions of paragraphs (6)(d) and (e), below, americium 241 in the form of calibration or reference sources:
1. Any person who holds a specific license issued by the Department which authorizes him to receive, possess, use and transfer radioactive material; and.
2. Any person who holds a specific license issued by the U.S. Nuclear Regulatory Commission which authorizes him to receive, possess, use and transfer special nuclear material.
(b) A general license is hereby issued to own, receive, possess, use and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of paragraphs (6)(d) and (e), below, to any person who holds a specific license issued by the Department which authorizes him to receive, possess, use and transfer radioactive material.
(c) A general license is hereby issued to own, receive, possess, use and transfer radium 226 in the form of calibration or reference sources in accordance with the provisions of paragraphs (6)(d) and (e), below, to any person who holds a specific license issued by the Department which authorizes him to receive, possess, use and transfer radioactive material.
(d) The general licenses in paragraph (6)(a), (b) and (c), above, apply only to calibration or reference sources which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the U.S. Nuclear Regulatory Commission pursuant to Section 32.57 of 10 C.F.R. Part 32 or Section 70.39 of 10 C.F.R. Part 70 or which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer by the Department, an Agreement State or Licensing State pursuant to licensing requirements equivalent to those contained in Section 32.57 of 10 C.F.R. Part 32 or Section 70.39 of 10 C.F.R. Part 70.
(e) The general licenses provided in paragraphs (6)(a), (b) and (c), above, are subject to the provisions of Rules 64E-5.103 through 64E-5.104, 64E-5.213, 64E-5.215, Parts III, IX and XV, F.A.C. In addition, persons who own, receive, acquire, possess, use or transfer one or more calibration or reference sources pursuant to these general licenses:
1. Shall not possess at any given time, at any single location of storage or use, more than 5 microcuries (185 kBq) of americium 241, 5 microcuries (185 kBq) of plutonium, or 5 microcuries (185 kBq) of radium 226 in such sources,
2. Shall not receive, possess, use or transfer such source unless the source, or the storage container, bears a label which includes one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, as appropriate:
a. The receipt, possession, use and transfer of this source, model ___, serial no. ___, are subject to a general license and the regulations 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. Do not remove this label.
CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS (AMERICIUM 241) (PLUTONIUM). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
____________________________
Name of manufacturer or importer
b. The receipt, possession, use and transfer of this source, model ___, serial no. ___, are subject to a general license and the regulations of a Licensing State. Do not remove this label.
CAUTION - RADIOACTIVE MATERIAL - THIS SOURCE CONTAINS RADIUM 226. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
____________________________
Name of manufacturer or importer
3. Shall not transfer, abandon or dispose of such source except by transfer to a person authorized by a license from the Department, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State to receive the source,
4. Shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain americium 241, plutonium or radium 226, which might otherwise escape during storage; and,
5. Shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.
(f) These general licenses do not authorize the manufacture of calibration or reference sources containing americium 241, plutonium or radium 226.
(7) Medical Diagnostic Uses.
(a) A general license shall be issued to any physician to receive, possess, transfer or use radioactive material set forth below for the stated diagnostic uses, provided, however, that the use is in accordance with the provision of paragraphs (7)(b), (c), and (d), below, the radioactive material is in the form of capsules, disposable syringes or other prepackaged individual doses; and the radioactive material has been manufactured in accordance with a specific license issued by the Department pursuant to subsection 64E-5.210(7), F.A.C., or by the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State pursuant to equivalent regulations authorizing distribution to persons under a general license pursuant to this subsection or its equivalent:
1. Chromium 51 as sodium radiochromate for determination of red blood cell volumes and studies of red blood cell survival time,
2. Cobalt 57 for the measurement of intestinal absorption of cyanocobalamin,
3. Cobalt 58 for the measurement of intestinal absorption of cyanocobalamin,
4. Cobalt 60 for the measurement of intestinal absorption of cyanocobalamin,
5. Iodine 125 as iodinated human serum albumin (IHSA) for determinations of blood and blood plasma volume,
6. Iodine 131 as sodium iodide for measurement of thyroid uptake; and,
7. Iodine 131 as iodinated human serum albumin (IHSA) for determinations of blood and blood plasma volume.
(b) No physician shall receive, possess, use or transfer radioactive material pursuant to the general license established by paragraph (7)(a), above, until he has submitted the original and one copy of the completed form DH 361, 10/12 and received from the Department a validated copy of this form with a certification number assigned. DH 361 10/12, entitled, "Certificate - Medical Use of Radioactive Material under General License, " is herein incorporated by reference and can be obtained from the internet at http://www.flrules.org/Gateway/reference.asp?No=Ref-03450, or at http://www.doh.state.fl.us/environment/radiation/matform.htm.
(c) A physician who receives, possesses or uses a pharmaceutical containing radioactive material pursuant to the general license established by paragraph (7)(a), above, shall comply with the following:
1. The physician shall not possess at any given time, pursuant to the general license in paragraph (7)(a), above, more than:
a. Two hundred microcuries (7.4 MBq) of iodine 131,
b. Two hundred microcuries (7.4 MBq) of iodine 125,
c. Five microcuries (185 kBq) of cobalt 57,
d. Five microcuries (185 kBq) of cobalt 58,
e. Five microcuries (185 kBq) of cobalt 60,
f. Two hundred microcuries (7.4 MBq) of chromium 51;
2. The physician shall store the pharmaceutical in the original shipping container until administered, or in a container providing equivalent radiation protection,
3. The physician shall use the pharmaceutical only for the uses authorized by paragraph (7)(a), above,
4. The physician shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the Department, the U.S. Nuclear Regulatory Commission, an Agreement State or Licensing State, or in any manner other than in the unopened, labeled shipping container as received from the supplier, except by administering it to a patient.
(d) The general licensed physician possessing or using radioactive material under the general license of paragraph (7)(a), above, shall report in duplicate to the Department any changes in the information furnished by him on Form 361. The report shall be submitted within 30 days after the effective date of such change.
(e) Any person using radioactive material pursuant to the general license of paragraph (7)(a), above, is exempt from the requirements of Parts III and IX with respect to the radioactive material covered by the general license.
(f) Manufacturers of radiopharmaceuticals which are under the general license in this subsection are required to affix a certain identifying label to the container, and in the leaflet or brochure which accompanies the radiopharmaceutical, pursuant to subsection 64E-5.210(7), F.A.C.
(8) General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing.
(a) A general license is hereby issued to any physician, veterinarian, clinical laboratory or hospital to receive, acquire, possess, transfer or use, for any of the following stated tests, in accordance with the provisions of paragraphs (8)(b), (c), (d), (e) and (f), below, the following radioactive materials in prepackaged units for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals:
1. Carbon 14, in units not exceeding 10 microcuries (370 kBq) each.
2. Cobalt 57, in units not exceeding 10 microcuries (370 kBq) each.
3. Hydrogen 3 (tritium), in units not exceeding 50 microcuries (1.85 MBq) each.
4. Iodine 125, in units not exceeding 10 microcuries (370 kBq) each.
5. Mock Iodine 125 reference or calibration sources, in units not exceeding 0.05 microcuries (1.85 kBq) of iodine 129 and 0.005 microcuries (0.185 kBq) of americium 241 each.
6. Iodine 131, in units not exceeding 10 microcuries (370 kBq) each.
7. Iron 59, in units not exceeding 20 microcuries (740 kBq) each.
8. Selenium 75, in units not exceeding 10 microcuries (370 kBq) each.
(b) No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general license established by paragraph (8)(a), above, until he has submitted the original and one copy of the completed form DH 360 10/12, and received from the Department a validated copy of this form with a certification number assigned. DH 360 10/12 entitled, "Certificate - In Vitro Testing with Radioactive Material under General License" is herein incorporated by reference and can be obtained from the internet at http://www.flrules.org/Gateway/reference.asp?No=Ref-03451, or at http://www.doh.state.fl.us/environment/radiation/matform.htm.
(c) A person who receives, acquires, possesses or uses radioactive material pursuant to the general license established by paragraph (8)(a), above, shall comply with the following:
1. The general licensee shall not possess at any given time, pursuant to the general license in paragraph (8)(a), above, at any single location of storage or use, a combined total amount of iodine 125, iodine 131, selenium 75, iron 59 or cobalt 57 in excess of 200 microcuries (7.4 MBq).
2. The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.
3. The general licensee shall use the radioactive material only for the uses authorized by paragraph (8)(a), above.
4. The general licensee shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the Department, the U.S. Nuclear Regulatory Commission, an Agreement State or Licensing State, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.
5. The general licensee shall dispose of the mock iodine 125 reference or calibration sources described in paragraph (8)(a), above, as required by Rule 64E-5.328, F.A.C.
(d) The general licensee shall not receive, acquire, possess or use radioactive material pursuant to paragraph (8)(a), above:
1. Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific license issued pursuant to subsection 64E-5.210(8), F.A.C., or in accordance with the provisions of a specific license issued by the U.S. Nuclear Regulatory Commission, an Agreement State or Licensing State which authorizes the manufacture and distribution of iodine 125, iodine 131, carbon 14, hydrogen 3 (tritium), iron 59, selenium 75, cobalt 57 or mock iodine 125 to persons under a general license described in this subsection or its equivalent; and,
2. Unless one of the following statements, as appropriate or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:
a. This radioactive material shall be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a state with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority.
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b. 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.
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(e) The physician, veterinarian, clinical laboratory or hospital possessing or using radioactive material under the general license of paragraph (8)(a), above, shall report in writing to the Department any changes in the information furnished by him in the "Certificate - In Vitro Testing with Radioactive Material Under General License". The report shall be furnished within 30 days after the effective date of such change.
(f) Any person using radioactive material pursuant to the general license of paragraph (8)(a), above, is exempt from the requirements of Parts III and IX with respect to radioactive material covered by that general license, except that such persons using the mock iodine 125 described in subparagraph (8)(a)5., above, shall comply with the provisions of Rules 64E-5.328, 64E-5.343, and 64E-5.344, F.A.C.
(g) The New Drug provisions of the Federal Food, Drug and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.
(9) Ice Detection Devices.
(a) A general license is hereby issued to own, receive, acquire, possess, use and transfer strontium 90 contained in ice detection devices, provided each device contains not more than 50 microcuries (1.85 MBq) of strontium 90 and each device has been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission or each device has been manufactured in accordance with the specifications contained in a specific license issued by the Department or an Agreement State to the manufacturer of such device pursuant to licensing requirements equivalent to those in Section 32.61 of 10 C.F.R. Part 32.
(b) Persons who own, receive, acquire, possess, use or transfer strontium 90 contained in ice detection devices pursuant to the general license in paragraph (9)(a), above:
1. Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license from the U.S. Nuclear Regulatory Commission or an Agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of Rule 64E-5.328, F.A.C.;
2. Shall assure that all labels affixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon; and,
(c) This general license does not authorize the manufacture, assembly, disassembly or repair of strontium 90 in ice detection devices.
(10) Ownership of Radioactive Material. A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this part, this general license does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material.
(11) Certain Items and Self-Luminous Products Containing Radium-226.
(a) A general license is hereby issued to any person to acquire, receive, possess, use, or transfer, in accordance with the provisions of subsections 64E-5.206(11)(b), (c), and (d), F.A.C., radium-226 contained in the following products manufactured prior to November 30, 2007.
1. Antiquities originally intended for use by the general public. For the purposes of this paragraph, antiquities mean products originally intended for use by the general public and distributed in the late 19th and early 20th centuries, such as radium emanatory jars, revigators, radium water jars, radon generators, refrigerator cards, radium bath salts, and healing pads.
2. Intact timepieces containing greater than 0.037 megabecquerel (1 microcurie), nonintact timepieces, and timepiece hands and dials no longer installed in timepieces.
3. Luminous items installed in air, marine, or land vehicles.
4. All other luminous products, provided that no more than 100 items are used or stored at the same location at any one time.
5. Small radium sources containing no more than 0.037 megabecquerel (1 microcurie) of radium-226. For the purposes of this paragraph, ''small radium sources'' means discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations (such as cloud chambers and spinthariscopes), electron tubes, lightning rods, ionization sources, static eliminators, or as designated by the NRC.
(b) Persons who acquire, receive, possess, use, or transfer byproduct material under the general license issued in paragraph 64E-5.206(11)(a), F.A.C., of this section are exempt from the provisions of Parts III and IX, to the extent that the receipt, possession, use, or transfer of radioactive materials is within the terms of the general license. This exemption shall not apply to any such person specifically licensed under Chapter 64E-5, F.A.C.
(c) Any person who acquires, receives, possesses, uses, or transfers byproduct material in accordance with the general license in subsection 64E-5.206(11)(a), F.A.C., must also comply with the following requirements:
1. Shall notify the Department should there be any indication of possible damage to the product so that it appears it could result in a loss of the radioactive material. A report containing a brief description of the event, and the remedial action taken, must be furnished to the Department within 30 days,
2. Shall not abandon products containing radium-226. The product, and any radioactive material from the product, may only be disposed of according to Rule 64E-5.328, F.A.C., or by transfer to a person authorized by a specific license to receive the radium-226 in the product or as otherwise approved by the Department,
3. Shall not export products containing radium-226 except in accordance with 10 C.F. R. Part 110, 1-1-14 edition which is herein incorporated by reference and can be obtained from the internet at http://www.flrules.org/Gateway/reference.asp?No=Ref-05472, or at http://www.gpo.gov/fdsys/pkg/CFR-2014-title10-vol2/pdf/CFR-2014-title10-vol2-part110.pdf,
4. Shall dispose of products containing radium-226 at a disposal facility authorized to dispose of radioactive material in accordance with any Federal or State solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005, by transfer to a person authorized to receive radium-226 by a specific license issued under Part III, or equivalent regulations of an Agreement State or the NRC, as otherwise approved by the Department.
5. Shall respond to written requests from the Department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Department a written justification for the request.
(d) Except for disassembly and repair of timepieces described in subparagraph 64E-5.206(11)(a) 2., F.A.C., the general license in paragraph 64E-5.206(11)(a), F.A.C., does not authorize the manufacture, assembly, disassembly, repair, or import of products containing radium-226.
Notes
Rulemaking Authority 404.051, 404.061, 404.071 FS. Law Implemented 404.051(1), (4), (6), (8), (9), (10), (11), 404.061(2), 404.071(1), (3), 404.081(1), 404.141 FS.
New 7-17-85, Amended 4-4-89, 1-1-94, Formerly 10D-91.306, Amended 9-28-06, 2-28-08, 12-26-13, 7-1-15.