Florida Regulations 64E-5.203: Radioactive Material Other Than Source Material – Exemptions
2. A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license to the extent that this person transfers radioactive material contained in a product or material in concentrations not in excess of those specified in Schedule A and introduced into the product or material by a licensee holding a specific license issued by the NRC expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.
(b) No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under paragraph (1)(a), above, or equivalent regulations of the NRC, an Agreement State or Licensing State, except in accordance with a specific license issued by the NRC pursuant to 10 C.F.R. § part section 32.11.
(2) Exempt Quantities.
(a) Except as provided in paragraphs (2)(b) through (e), below, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in Schedule B.
(b) This paragraph does not authorize the production, packaging or repackaging of radioactive material for purposes of commercial distribution, or the incorporation of radioactive material into products intended for commercial distribution.
(c) No person may, for purposes of commercial distribution, transfer radioactive material in the individual quantities set forth in Schedule B, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under this section or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or Licensing State, except in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, pursuant to Section 32.18 of 10 C.F.R. part 32, or by the Department, pursuant to subsection 64E-5.210(2), F.A.C., which license states that the radioactive material may be transferred by the licensee to persons exempt under this subsection or the equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or Licensing State. Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
(d) No person may, for purposes of producing an increased radiation level, combine quantities of byproduct material covered by this exemption so that the aggregate quantity exceeds the limits set forth in Schedule B, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the regulations in this part.
(e)1. Any person, who possesses radioactive material received or acquired before September 25, 1971, under the then existing general license issued to transfer, receive, acquire, own, possess, use and import quantities of radioactive materials listed in subFl. Admin. Code R. 64E-5.203(2)(e)2., Table of General Licensed Quantities prior to September 25, 1971 below, or similar general license of a State, or provided that no person shall at any one time possess or use, pursuant to the general license provisions of this section, more than a total of ten such quantities.
2. Below is the Table of General Licensed Quantities prior to September 25, 1971:
Radioactive material
Column No. I
Not as a sealed source (microcuries)
Column No. III
As a sealed source (microcuries)
a.
Antimony (Sb 124)
1
10
b.
Arsenic 76 (As 76)
10
10
c.
Arsenic 77 (As 77)
10
10
d.
Barium 140 – Lanthanum 140 (Ba La 140)
1
10
e.
Beryllium 7 (Be 7)
50
50
f.
Cadmium 109 – Silver 109 (Cd Ag 109)
10
10
g.
Calcium 45 (Ca 45)
10
10
h.
Carbon 14 (C 14)
50
50
i.
Cerium 144 – Praseodymium (Ce Pr 144)
1
10
j.
Cesium – Barium 137 (Cs Ba 137)
1
10
k.
Chlorine 36 (Cl 36)
1
10
l.
Chromium 51 (Cr 51)
50
50
m.
Cobalt 60 (Co 60)
1
10
n.
Copper 64 (Cu 64)
50
50
o.
Europium 154 (Eu 154)
1
10
p.
Fluorine 18 (F 18)
50
50
q.
Gallium 72 (Ga 72)
10
10
r.
Germanium 71 (Ge 71)
50
50
s.
Gold 198 (Au 198)
10
10
t.
Gold 199 (Au 199)
10
10
u.
Hydrogen 3 (Tritium) (H 3)
250
250
v.
Indium 114 (In 114)
1
10
w.
Iodine 131 (I-131)
10
10
x.
Iridium 192 (Ir 192)
10
10
y.
Iron 55 (Fe 55)
50
50
z.
Iron 59 (Fe 59)
1
10
aa.
Lanthanum 140 (La 140)
10
10
bb.
Manganese 52 (Mn 52)
1
10
cc.
Manganese 56 (Mn 56)
50
50
dd.
Molybdenum 99 (Mo 99)
10
10
ee.
Nickel 59 (Ni 59)
1
10
ff.
Nickel 63 (Ni 63)
1
10
gg.
Niobium 95 (Nb 95)
10
10
hh.
Palladium 109 (Pd 109)
10
10
ii.
Palladium 103 – Rhodium 103 (Pd-Rh 103)
50
50
jj.
Phosphorus 32 (P 32)
10
10
kk.
Polonium 210 (Po 210)
0.1
1
ll.
Potassium 42 (K 42)
10
10
mm.
Praseodymium 143 (Pr 143)
10
10
nn.
Promethium 147 (Pm 147)
10
10
oo.
Rhenium 186 (Re 186)
10
10
pp.
Rhodium 105 (Rh 105)
10
10
qq.
Rubidium 86 (Rb 86)
10
10
rr.
Ruthenium 106 – Rhodium 106 (Ru Rh 106)
1
10
ss.
Samarium 153 (Sm 153)
10
10
tt.
Scandium 46 (Sc 46)
1
10
uu.
Silver 105 (Ag 105)
1
10
vv.
Silver 111 (Ag 111)
10
10
ww.
Sodium 22 (Na 22)
10
10
xx.
Sodium 24 (Na 24)
10
10
yy.
Strontium 89 (Sr 89)
1
10
zz.
Strontium 89 – Yttrium 90 (Sr Y 90)
0.1
1
aaa.
Sulfur 35 (S 35)
50
50
bbb.
Tantalum 182 (Ta 182)
10
10
ccc.
Technetium 96 (Tc 96)
1
10
ddd.
Technetium 99 (Tc 99)
1
10
eee.
Tellurium 127 (Te 127)
10
10
fff.
Tellurium 129 (Te 129)
1
10
ggg.
Thallium 204 (Tl 204)
50
50
hhh.
Tin 112 (Sn 113)
10
10
iii.
Tungsten 185 (W 185)
10
10
jjj.
Vanadium 48 (V 48)
1
10
kkk.
Yttrium 90 (Y 90)
1
10
lll.
Yttrium 91 (Y 91)
1
10
mmm.
Zinc 65 (Zn 65)
10
10
nnn.
Beta or Gamma emitting radioactive material not listed above
1
10
(3) Exempt Items.
(a) Certain Items Containing Radioactive Material. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into, the following products, any person is exempt from these regulations to the extent that he receives, possesses, uses, transfers, owns or acquires the following products. Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC, Washington, D.C. 20555:
1. Timepieces, hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified amount of radioactive material or dose rate, as applicable:
a. Twenty-five millicuries (925 MBq) of tritium per timepiece,
b. Five millicuries (185 MBq) of tritium per hand,
c. Fifteen millicuries (555 MBq) of tritium per dial; bezels when used shall be considered as part of the dial,
d. One hundred microcuries (3.7 MBq) of promethium 147 per watch or two hundred microcuries (7.4 MBq) of promethium 147 per any other timepiece,
e. Twenty microcuries (0.74 MBq) of promethium 147 per watch hand or 40 microcuries (1.48 MBq) of promethium 147 per other timepiece hand,
f. Sixty microcuries (2.22 MBq) of promethium 147 per watch dial or 120 microcuries (4.44 MBq) of promethium 147 per other timepiece dial; bezels, when used, shall be considered as part of the dial; and,
g. The radiation dose rate from hands and dials containing promethium 147 or radium 226 will not exceed, when measured through 50 milligrams per square centimeter of absorber:
(I) For wrist watches, 0.1 millirad (1 uGy) per hour at 10 centimeters from any surface,
(II) For pocket watches, 0.1 millirad (1 uGy) per hour at 1 centimeter from any surface. Radium shall not be used for pocket watches; and,
(III) For any other timepiece, 0.2 millirad (2 uGy) per hour at 10 centimeters from any surface,
h. One microcurie (37 kBq) of radium 226 per timepiece in intact timepieces manufactured prior to November 30, 2007.
2. Ionization chamber smoke detectors containing not more than 1 microcurie (µCi) of americium-241 per detector in the form of a foil and designed to protect life and property from fires.
3. Precision balances containing not more than 1 millicurie (37 MBq) of tritium per balance or not more than 0.5 millicurie (18.5 MBq) of tritium per balance part manufactured before December 17, 2007.
4. Marine compasses containing not more than 750 millicuries (27.8 GBq) of tritium gas and other marine navigational instruments containing not more than 250 millicuries (9.25 GBq) of tritium gas manufactured before December 17, 2007.
5. Electron tubes, including spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes and any other completely sealed tube that is designed to conduct or control electrical currents; provided, that the radiation dose rate from each electron tube containing radioactive material shall not exceed 1 millirad (10 uGy) per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber, and that each tube does not contain more than one of the following specified quantities of radioactive material:
a. One hundred fifty millicuries (5.55 GBq) of tritium per microwave receiver protector tube or 10 millicuries (370 MBq) of tritium per any other electron tube.
b. One microcurie (37 kBq) of cobalt 60.
c. Five microcuries (185 kBq) of nickel 63.
d. Thirty microcuries (1.11 MBq) of krypton 85.
e. Five microcuries (185 kBq) of cesium 137.
f. Thirty microcuries (1.11 MBq) of promethium 147.
6. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:
a. Each source contains no more than one exempt quantity set forth in Schedule B; and,
b. Each instrument contains no more than 10 exempt quantities. For purposes of this requirement, an instrument’s source may contain either one or different types of radionuclides and an individual exempt quantity may be composed of fractional parts of one or more of the exempt quantities in Schedule B, provided that the sum of such fractions shall not exceed unity.
c. For americium 241, 0.05 microcurie (1.85 kBq) is considered an exempt quantity under this subparagraph.
(b) Self-Luminous Products Containing Radioactive Material.
1. Tritium, Krypton 85 or Promethium 147. Except for persons who manufacture, process or produce self-luminous products containing tritium, krypton 85 or promethium 147, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires tritium, krypton 85 or promethium 147 in self-luminous products manufactured, or processed, produced, imported or transferred in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission pursuant to Section 32.22 of 10 C.F.R. part 32, which license authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in this paragraph does not apply to tritium, krypton 85 or promethium 147 used in products for frivolous purposes or in toys or adornments.
2. Radium 226. Any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers or owns articles containing less than 0.1 microcurie (3.7 kBq) of radium 226 which were acquired prior to December 1980.
(c) Gas and Aerosol Detectors Containing Radioactive Material.
1. Except for persons who manufacture, process, produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards, provided that detectors containing radioactive material shall have been manufactured, processed, produced, imported or initially transferred in accordance with a specific license issued by the NRC pursuant to Section 32.26 of 10 C.F.R. part 32. Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC, Washington, D.C. 20555.
2. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007 in accordance with a specific license issued by a State under comparable 10 CFR, section 32.26 authorizing distribution to persons exempt from regulatory requirements.
(4) Radioactive drug: capsules containing carbon 14 urea for in vivo diagnostic use for humans.
(a) Except as provided in paragraphs (b) and (c), of this rule, any person is exempt from the requirements for a license set forth in these regulations if such person receives, possesses, uses, transfers, owns, or acquires capsules containing 1 microcurie (37 kBq) carbon 14 urea each, allowing for nominal variation that can occur during the manufacturing process, for in vivo diagnostic use for humans.
(b) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license as specified in these regulations.
(c) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license as specified in 10 C.F.R. part 32, Sec. 32.21.
(d) Nothing in this section relieves a person from complying with applicable FDA, other Federal, and State requirements governing receipt, administration, and use of drugs.
Rulemaking Authority 404.051, 404.061, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (10), 404.141 FS. History-New 7-17-85, Amended 4-4-89, Formerly 10D-91.303, Amended 10-8-00, Amended 12-26-13.