(1) Except as otherwise specifically provided, this chapter applies to all persons who receive, possess, use, transfer, own or acquire any source of radiation; provided, however, that nothing in these rules shall apply to any person to the extent such person is subject to regulation by the United States nuclear regulatory commission. Regulation by Montana of source material, byproduct material, and special nuclear material in quantities not sufficient to form a critical mass is subject to the provisions of the agreement between Montana and the United States nuclear regulatory commission and to 10 CFR Part 150 of its regulations.

As used in this chapter, these terms have the definitions set forth below. Additional definitions used only in a certain subchapter will be found in that subchapter.

(1) "Accelerator-produced material" means any material made radioactive by a particle accelerator.

(2) "Act" means Title 75, chapter 3, MCA.

(3) "Agreement state" means any state with which the US nuclear regulatory commission or the US atomic energy commission has entered into an effective agreement under subsection 274b. of the Atomic Energy Act of 1954, as amended (73 Stat. 689) .

(4) "Airborne radioactive material" means any radioactive material dispersed in the air in the forms of dusts, fumes, mists, vapors, or gases.

(5) "Airborne radioactivity area" means:

(a) any room, enclosure, or operating area in which airborne radioactive material exists in concentrations in excess of the amounts specified in Appendix A, Table I, Column 1, of subchapter 7; or

(b) any room, enclosure, or operating area in which airborne radioactive material exists in concentrations which, averaged over the number of hours in any week during which individuals are in the area, exceed 25% of the amounts specified in Appendix A, Table I, Column 1 of subchapter 7.

(6) "Byproduct material" means a radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material.

(7) "Calendar quarter" means not less than 12 consecutive weeks nor more than 14 consecutive weeks. The first calendar quarter of each year shall begin in January and subsequent calendar quarters shall be so arranged such that no day is included in more than 1 calendar quarter and no day in any 1 year is omitted from inclusion within a calendar quarter. No licensee or registrant shall change the method observed by him of determining calendar quarters for purposes of these rules except at the beginning of a calendar year.

(8) "CFR" means code of federal regulations.

(9) "Curie" means a unit of measurement of radioactivity. One curie (Ci) is that quantity of radioactive material which decays at the rate of 3.7 x 10¹⁰ disintegrations per second (dps) . Commonly used submultiples of the curie are the millicurie and the microcurie. One millicurie (mCi) =0.001 curie=3.7 x 10⁷ dps. One microcurie ( : Ci) =0.000001 curie=3.7 x 10⁴ dps.

(10) "Department" means the department of public health and human services.

(11) "Depleted uranium" means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present. Depleted uranium does not include special nuclear material.

(12) "Dose" as used in this chapter means absorbed dose or dose equivalent as appropriate.

(a) "Absorbed dose" is the energy imparted to matter by ionizing radiation per unit mass of irradiated material at the place of interest. The special unit of absorbed dose is the rad.

(b) "Dose equivalent" is a quantity that expresses on a common scale for all radiation a measure of the postulated effect on a given organ. It is defined as the absorbed dose in rads times certain modifying factors. The unit of dose equivalent is the rem.

(13) "Dose commitment" means the total radiation dose to a part of the body that will result from retention in the body of radioactive material. For purposes of estimating the dose commitment, it is assumed that from the time of intake the period of exposure to retained material will not exceed 50 years.

(14) "Exposure" means the quotient of dQ by dm where "dQ" is the absolute value of the total charge of the ions of 1 sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "dm" are completely stopped in air.

(15) "Exposure rate" means the exposure per unit of time, such as Roentgen (R) per minute and mR per hour.

(16) "Former United States atomic energy commission (AEC) or United States nuclear regulatory commission (NRC) licensed facilities" means nuclear reactors, nuclear fuel reprocessing plants, uranium enrichment plants, or critical mass experimental facilities where AEC or NRC licenses have been terminated.

(17) "Healing arts" means diagnostic and/or healing treatment of human and animal maladies including but not limited to the following which are duly licensed by the state of Montana for the lawful practice of: medicine and its associated specialties, dentistry, veterinary medicine, osteopathy, chiropractic, and podiatry.

(18) "High radiation area" means any area, accessible to individuals, in which there exists radiation at such levels that a major portion of the body could receive in any 1 hour a dose in excess of 100 millirems.

(19) "Human use" means the internal or external administration of radiation or radioactive material to human beings.

(20) "Individual" means any human being.

(21) "Inspection" means an official examination or observation including but not limited to, tests, surveys, and monitoring to determine compliance with rules, regulations, orders, requirements and conditions of the department.

(22) "License" means a license issued by the department in accordance with the rules adopted by the department.

(23) "Licensee" means any person who is licensed by the department in accordance with these rules and the act.

(24) "Licensing state" means any state with regulations equivalent to the suggested state regulations for control of radiation relating to, and an effective program for, the regulatory control of NARM.

(25) "Major processor" means a user processing, handling, or manufacturing radioactive material exceeding Type A quantities as unsealed sources or material, or exceeding 4 times Type B quantities as sealed sources, but does not include nuclear medicine programs, universities, industrial radiographers or small industrial programs. Type A quantity and Type B quantity is a quantity of radioactive material the aggregate radioactivity of which does not exceed that specified in the following table:

 

Transport Groups (see Table A)	Type A Quantity (in curies)	Type B Quantity (in curies)
I	0.001	20
II	0.05	20
III	3	200
IV	20	5,000
V	20	50,000
VI and VII	1,000	5,000
Special form	20*	5,000

  *Except that for californium-252, the limit is 2 Ci.

 

(26) "NARM" means any naturally occurring or accelerator-produced radioactive material except source material.

(27) "Natural radioactivity" means radioactivity of naturally occurring nuclides.

(28) "Occupational dose" means exposure of an individual to radiation:

(a) in a restricted area; or

(b) in the course of employment in which the individual's duties involve exposure to radiation; provided, that occupational dose shall not be deemed to include any exposure of an individual to radiation for the purpose of diagnosis or therapy of such individual.

(29) "Ore refineries" means all processors of a radioactive material ore.

(30) "Particle accelerator" means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 MeV.

(31) "Person" means "any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision or agency thereof, and any legal successor, representative, agent or agency of the foregoing, other than the United States nuclear regulatory commission, any successor thereto, or federal agencies licensed by the nuclear regulatory commission."

(32) "Personnel monitoring equipment" means devices (e.g., film badges, pocket dosimeters, and thermoluminescent dosimeters) designed to be worn or carried by an individual for the purpose of estimating the dose received by the individual.

(33) "Pharmacist" means an individual licensed by this state to compound and dispense drugs, prescriptions, and poisons.

(34) "Physician" means a duly licensed physician authorized to dispense drugs in the practice of medicine in Montana.

(35) "Rad" means the special unit of absorbed dose. One rad equals one hundredth of a joule per kilogram of material; for example, if tissue is the material of interest, then 1 rad equals 100 ergs per gram of tissue.

(36) "Radiation" means ionizing radiation, i.e., gamma rays and x-rays, alpha and beta particles, high speed electrons, neutrons, and other nuclear particles.

(37) "Radiation area" means any area, accessible to individuals, in which there exists radiation at such levels that a major portion of the body could receive in any 1 hour a dose in excess of 5 millirems, or in any 5 consecutive days a dose in excess of 100 millirems.

(38) "Radiation machine" means any device capable of producing radiation except those which produce radiation only from radioactive material.

(39) "Radiation safety officer" means one who has the knowledge and responsibility to apply appropriate radiation protection regulations.

(40) "Radioactive material" means any material (solid, liquid, or gas) which emits radiation spontaneously.

(41) "Radioactivity" means the disintegration of unstable atomic nuclei by the emission of radiation.

(42) "Registrant" means any person who is registered with the department and is legally obligated to register with the department pursuant to this chapter and the act.

(43) "Registration" means "the registering with the department by the legal owner, user, or authorized representative of sources of ionizing radiation in the manner prescribed by rule."

(44) "Regulations of the US department of transportation" means the regulations in 49 CFR Parts 100-189.

(45) "Rem" means a measure of the dose of any radiation to body tissue in terms of its estimated biological effect relative to a dose received from an exposure to 1 roentgen (R) of x-rays. (1 millirem (mrem) =0.001 rem) For the purpose of this chapter, any of the following is considered to be equivalent to a dose of 1 rem:

(a) An exposure of 1 R of X, or gamma radiation.

(b) A dose of 1 rad due to X, gamma, or beta radiation.

(c) A dose of 0.05 rad due to particles heavier than protons and with sufficient energy to reach the lens of the eye.

(d) A dose of 0.1 rad due to neutrons or high energy protons.

(i) If it is more convenient to measure the neutron flux, or equivalent, than to determine the neutron absorbed dose in rads, 1 rem of neutron radiation may, for purposes of this chapter, be assumed to be equivalent to 14 million neutrons per square centimeter incident upon the body; or if there exists sufficient information to estimate with reasonable accuracy the approximate distribution in energy of the neutrons, the incident number of neutrons per square centimeter equivalent to 1 rem may be estimated from the following table:

 

Neutron Flux Dose Equivalents

 

Neutron energy (MeV)	Number of neutrons per square centimeter for a dose equivalent of 1 rem (neutrons/cm2)	Average flux density to deliver 100 millirems in 40 hours (neutrons/cm2 per second)
Thermal . . . . . . . . . . . . . . 970 x 106 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 670 0.0001 . . . . . . . . . . . . . . . 720 x 106 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 500 0.005 . . . . . . . . . . . . . . . . 820 x 106 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 570 0.02 . . . . . . . . . . . . . . . . . 400 x 106 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 280 0.1 . . . . . . . . . . . . . . . . . . 120 x 106 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 0.5 . . . . . . . . . . . . . . . . . . . 43 x 106 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 1.0 . . . . . . . . . . . . . . . . . . . 26 x 106. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 2.5 . . . . . . . . . . . . . . . . . . . 29 x 106 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 5.0 . . . . . . . . . . . . . . . . . . . 26 x 106 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 7.5 . . . . . . . . . . . . . . . . . . . 24 x 106 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 10.0 . . . . . . . . . . . . . . . . . . 24 x 106 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 10 to 30 . . . . . . . . . . . . . . . 14 x 106. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

 

(46) "Research and development" means theoretical analysis, exploration, or experimentation; or the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

(47) "Restricted area" (controlled area) means any area access to which is controlled by the licensee or registrant for purposes of protection of individuals from exposure to radiation and radioactive material. "Restricted area" shall not include any areas used for residential quarters, although a separate room or rooms in a residential building may be set apart as a restricted area.

(48) "Roentgen" (R) means the special unit of exposure. One roentgen equals 2.58 x 10^-4 coulombs/kilogram of air.

(49) "Sealed source" means radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and handling.

(50) "Source material" means uranium, thorium, or any other material which the department or the United States nuclear regulatory commission declares by order to be source material or ores containing 1 or more of the foregoing materials in such concentration as the department or the nuclear regulatory commission declares by order to be source material after the nuclear regulatory commission has determined the material in such concentration to be source material.

(51) "Source of radiation" means any radioactive material, or any device or equipment emitting or capable of producing radiation.

(52) "Special form" means any of the following physical forms of licensed material of any transport group:

(a) The material is in solid form having no dimension less than 0.5 millimeter or at least 1 dimension greater than 5 millimeters; does not melt, sublime, or ignite in air at a temperature of 1,000 E F; will not shatter or crumble if subjected to the percussion test described in Table B of this subchapter; and is not dissolved or converted into dispersible form to the extent of more than 0.005% by weight by immersion for 1 week in water at 68 E F or in air at 86 E F.

(b) The material is securely contained in a capsule having no dimension less than 0.5 millimeter or at least 1 dimension greater than 5 millimeters, which will retain its contents if subjected to the tests prescribed in Appendix B of this subchapter and which is constructed of materials which do not melt, sublime, or ignite in air at 1,475 E F, and do not dissolve or convert into dispersible form to the extent of more than 0.005% by weight by immersion for 1 week in water at 68 E F or in air at 86 E F.

(53) "Special nuclear material in quantities not sufficient to form a critical mass" means uranium enriched in the isotope U-235 in quantities not exceeding 350 grams of contained U-235; uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not exceeding 200 grams; or any combination of them in accordance with the following formula: For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed "1" (i.e., unity) . For example, the following quantities in combination would not exceed the limitation and are within the formula:

175 (grams contained U-235)	+ 50(grams U-233)	+ 50(grams Pu )	=1
350	200	200

 

(54) "Survey" means an evaluation of the production, use, release, disposal, and/or presence of sources of radiation under a specific set of conditions to determine actual or potential radiation hazards. When appropriate, such evaluation includes, but is not limited to tests, physical examination and measurements of levels of radiation or concentration of radioactive material present.

(55) "Test" means a method for determining the characteristics of condition of sources of radiation or components thereof.

(56) "Transport group" means any 1 of 7 groups into which radionuclides in normal form are classified, according to their toxicity and their relative potential hazard in transport, in Table A of this subchapter.

(a) Any radionuclide not specifically listed in 1 of the groups in Table A shall be assigned to 1 of the groups in accordance with the following table:

 

Radioactive half-life

 

Radionuclide	0 to 1000 days	1000 days to 106 years	Over 106 years
Atomic number 1-81	Group III	Group II	Group III
Atomic number 82 and over.	Group I	Group I	Group III

 

(b) For mixtures of radionuclides the following shall apply:

(i) If the identity and respective activity of each radionuclide are known, the permissible activity of each radionuclide shall be such that the sum, for all groups present, of the ratio between the total activity for each group to the permissible activity for each group will not be greater than unity.

(ii) If the groups of the radionuclides are known but the amount in each group cannot be reasonably determined, the mixture shall be assigned to the most restrictive group present.

(iii) If the identity of all or some of the radionuclides cannot be reasonably determined, each of those unidentified radionuclides shall be considered as belonging to the most restrictive group which cannot be positively excluded.

(iv) Mixtures consisting of a single radioactive decay chain where the radionuclides are in the naturally occurring proportions shall be considered as consisting of a single radionuclide. The group and activity shall be that of the first member present in the chain, except that if a radionuclide "X" has a half-life longer than that of that first member and an activity greater than that of any other member, including the first, at any time during transportation, the transport group of the nuclide "X" and the activity of the mixture shall be the maximum activity of that nuclide "X" during transportation.

(57) "US department of energy" means the department of energy established by Public Law 95-91, August 4, 1977, 91 Stat. 565, 42 USC 7101, et seq., to the extent that the department exercises functions formerly vested in the US atomic energy commission, its chairman, its members, officers and components and transferred to the US energy research and development administration and to the administrator thereof pursuant to sections 104(b) , (c) and (d) of the Energy Reorganization Act of 1974 (Public Law 93-438, October 11, 1974, 88 Stat. 1233 at 1237, effective January 19, 1975) and retransferred to the secretary of energy pursuant to section 301(a) of the Department of Energy Organization Act (Public Law 95-91, August 4, 1977, 91 Stat. 565 at 577-578, 42 USC 7151, effective October 1, 1977) .

(58) "Unrefined and unprocessed ore" means ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.

(59) "Unrestricted area" (uncontrolled area) means any area access to which is not controlled by the licensee or registrant for purposes of protection of individuals from exposure to radiation and radioactive material, and any area used for residential quarters.

(60) "Waste handling licensees" mean persons licensed to receive and store radioactive wastes prior to disposal and/or persons licensed to dispose of radioactive waste.

(61) "Worker" means an individual engaged in work under a license or registration issued by the department and controlled by a licensee or registrant, but does not include the licensee or registrant.

 

(1) The department may, upon application therefor or upon its own initiative, grant such exemptions or exceptions from the requirements of this chapter as it determines are authorized by law and will not result in undue hazard to public health and safety or property.

(2) Common and contract carriers, freight forwarders, and warehousemen, who are subject to the rules and regulations of the US department of transportation or the US postal service (39 CFR Parts 14 and 15) , are exempt from this chapter to the extent that they transport or store sources of radiation in the regular course of their carriage for another or storage incident thereto. Private carriers who are subject to the rules and regulations of the US department of transportation are exempt from this chapter to the extent that they transport sources of radiation. Common, contract, and private carriers who are not subject to the rules and regulations of the US department of transportation or the US postal service are subject to the applicable rules of this chapter.

(3) Any US department of energy contractor or subcontractor and any US nuclear regulatory commission contractor or subcontractor of the following categories operating within Montana is exempt from this chapter to the extent that such contractor or subcontractor under his contract receives, possesses, uses, transfers or acquires sources of radiation:

(a) prime contractors performing work for the US department of energy at US government-owned or controlled sites, including the transportation of sources of radiation to or from such sites and the performance of contract services during temporary interruptions of such transportation;

(b) prime contractors of the US department of energy performing research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof;

(c) prime contractors of the US department of energy using or operating nuclear reactors or other nuclear devices in a United States government-owned vehicle or vessel; and

(d) any other prime contractor or subcontractor of the US department of energy or of the US nuclear regulatory commission when the department and the nuclear regulatory commission jointly determine:

(i) that the exemption of the prime contractor or subcontractor is authorized by law; and

(ii) that under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety.

(1) Each licensee and registrant shall maintain records showing the receipt, transfer, and disposal of all sources of radiation. Additional record requirements are specified elsewhere in this chapter.

(1) Each licensee and registrant shall afford the department at all reasonable times opportunity to inspect sources of radiation and the premises and facilities wherein such sources of radiation are used or stored.

(2) Each licensee and registrant shall make available to the department for inspection, upon reasonable notice, records maintained pursuant to this chapter.

(1) Each licensee and registrant shall perform upon instructions from the department, or shall permit the department to perform, such reasonable tests as the department deems appropriate or necessary including, but not limited to, tests of:

(a) sources of radiation;

(b) facilities wherein sources of radiation are used or stored;

(c) radiation detection and monitoring instruments; and

(d) other equipment and devices used in connection with utilization or storage of licensed or registered sources of radiation.

(1) No person may use hand-held fluoroscopic screens or shoe-fitting fluoroscopic devices.

(1) All communications and reports concerning this chapter, and applications filed thereunder, should be addressed to the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 2025953, Helena, MT 59620-5953.

TABLE A

TRANSPORT GROUPING OF RADIONUCLIDES

 

Element1	Radionuclide2	Group
Actinium (89)   Americium (95)   Antimony (51)     Argon (18)     Arsenic (33)	Ac-227 Ac-228 Am-241 Am-243 Sb-122 Sb-124 Sb-125 Ar-37 Ar-41 Ar-41 (uncompressed) 3 As-73 As-74 As-76 As-77	I I I I IV III III VI II V IV IV IV IV
Astatine (85) Barium (56)     Berkelium (97) Beryllium (4) Bismuth (83)       Bromine (35) Cadmium (48)     Calcium (20)   Californium (98)     Carbon (6)	At-211 Ba-131 Ba-133 Ba-140 Bk-249 Be-7 Bi-206 Bi-207 Bi-210 Bi-212 Br-82 Cd-109 Cd-115m Cd-115 Ca-45 Ca-47 Cf-249 Cf-250 Cf-252 C-14	III IV II III I IV IV III II III IV IV III IV IV IV I I I IV

 

¹ Atomic number shown in parentheses.

² Atomic mass number shown after the element symbol.

³ Uncompressed means at a pressure not exceeding 1 atmosphere.

^m Mestastable state.

Element1	Radionuclide2	Group
Cerium (58)     Cesium (55)       Chlorine (17)   Chromium (24) Cobalt (27)	Ce-141 Ce-143 Ce-144 Cs-131 Cs-134m Cs-134 Cs-135 Cs-136 Cs-137 Cl-36 Cl-38 Cr-51 Co-56 Co-57 Co-58m Co-58 Co-60	IV IV III IV III III IV IV III III IV IV III IV IV IV III
Copper (29) Curium (96)       Dysprosium (66)     Erbium (68)   Europium (63)       Fluorine (9) Gadolinium (64)   Gallium (31)   Germanium (32)	Cu-64 Cm-242 Cm-243 Cm-244 Cm-245 Cm-246 Dy-154 Dy-165 Dy-166 Er-169 Er-171 Eu-150 Eu-152m Eu-152 Eu-154 Eu-155 F-18 Gd-153 Gd-159 Ga-67 Ga-72 Ge-71	IV I I I I I III IV IV IV IV III IV III II IV IV IV IV III IV IV

 

¹ Atomic number shown in parentheses.

² Atomic mass number shown after the element symbol.

^m Mestastable state.

 

Element1	Radionuclide2	Group
Gold (79)	Au-193 Au-194 Au-195 Au-196 Au-198 Au-199	III III III IV IV IV
Hafnium (72) Holmiun (67)	Hf-181 Ho-166	IV IV
Hydrogen (1)	H-3 (see tritium)
Indium (49)	In-113m In-114m In-115m In-115	IV III IV IV
Iodine (53)	I-124 I-125 I-126 I-129 I-131 I-132 I-133 I-134 I-135	III III III III III IV III IV IV
Iridium (77)	Ir-190 Ir-192 Ir-194	IV III IV
Iron (26)	Fe-55 Fe-59	IV IV
Krypton (36)	Kr-85m Kr-85m (uncompressed) 3 Kr-85 Kr-85 (uncompressed) 3 Kr-87 Kr-87 (uncompressed) 3	III V III VI II V
Lanthanum (57) Lead (82)	La-140  Pb-203 Pb-210 Pb-212	IV IV II II

       

^{1 Atomic number shown in parentheses.}

2 Atomic mass number shown after the element symbol.

3 Uncompressed means at a pressure not exceeding 1 atmosphere.

m Mestastable state.

Element1	Radionuclide2	Group
Lutetium (71)   Magnesium (12) Manganese (25)     Mercury (80)     Mixed fission products Molybdenum (42) Neodymium (60)   Neptunium (93)   Nickel (28)	Lu-172 Lu-177 Mg-28 Mn-52 Mn-54 Mn-56 Hg-197m Hg-197 IV Hg-203 IV (MFP) Mo-99 Nd-147 Nd-149 Np-237 Np-239 Ni-56 Ni-59 Ni-63 Ni-65	III IV III IV IV IV IV IV IV II IV IV IV I I III IV IV IV
Niobium (41)     Osmium (76)	Nb-93m Nb-95 Nb-97 Os-185 Os-191m Os-191 Os-193	IV IV IV IV IV IV IV
Palladium (46)   Phosphorus (15) Platinum (78)       Plutonium (94)	Pd-103 Pd-109 P-32 Pt-191 Pt-193 Pt-193m Pt-197m Pt-197 Pu-238 (F) Pu-239 (F) Pu-240 Pu-241 (F) Pu-242	IV IV IV IV IV IV IV IV I I I I I

 

¹ Atomic number shown in parentheses.

² Atomic mass number shown after the element symbol.

^m Mestastable state.

(F) Fissile material.

RADIATION CONTROL

 

Element1	Radionuclide2	Group
Polonium (84) Potassium (19)   Praseodymium (59)   Promethium (61)   Protactinium (91)     Radium (88)       Radon (86)   Rhenium (75)	Po-210 K-42 K-43 Pr-142 Pr-143 Pm-147 Pm-149 Pa-230 Pa-231 Pa-233 Ra-223 Ra-224 Ra-226 Ra-228 Rn-220 Rn-222 Re-183 Re-186 Re-187 Re-188 Re-Natural	I IV III IV IV IV IV I I II II II I I IV II IV IV IV IV IV
Rhodium (45)   Rubidium (37)     Ruthenium (44)       Samarium (62)       Scandium (21)	Rh-103m Rh-105 Rb-86 Rb-87 Rb-Natural Ru-97 Ru-103 Ru-105 Ru-106 Sm-145 Sm-147 Sm-151 Sm-153 Sc-46 Sc-47 Sc-48	IV IV IV IV IV IV IV IV III III III IV IV III IV IV

 

¹ Atomic number shown in parentheses.

² Atomic mass number shown after the element symbol.

^m Mestastable state.

Element1	Radionuclide2	Group
Selenium (34) Silicon (14) Silver (47)     Sodium (11)   Strontium (38)	Se-75 Si-31 Ag-105 Ag-110m Ag-111 Na-22 Na-24 Sr-85m Sr-85 Sr-89 Sr-90 Sr-91 Sr-92 Sr-89 Sr-90 Sr-91 III Sr-92 II	IV IV IV III IV III IV IV IV III II III IV III II III II
Sulfur (16) Tantalum (73) Technetium (43)	S-35 Ta-182 Tc-96m Tc-96 Tc-97m Tc-97 Tc-99m Tc-99	IV III IV IV IV IV IV IV
Tellurium (52)       Terbium (65) Thallium (81)	Te-125m Te-127m Te-127 Te-129m Te-129 Te-131m Te-132 Tb-160 Tl-200 Tl-201 Tl-202 Tl-204	IV IV IV III IV III IV III IV IV IV III

 

¹ Atomic number shown in parentheses.

² Atomic mass number shown after the element symbol.

^m Mestastable state.

RADIATION CONTROL

 

Element1	Radionuclide2	Group
Thorium (90)       Thulium (69)     Tin (50)       Tritium (1)	Th-227 Th-228 Th-230 Th-231 Th-232 Th-234 Th-Natural Tm-168 Tm-170 Tm-171 Sn-113 Sn-117m Sn-121 Sn-125 H-3 H-3 (as a gas, as luminous paint, or adsorbed on solid material)	II I I I III II III III III IV IV III III IV IV VII
Tungsten (74)     Uranium (92)       Vanadium (23)	W-181 W-185 W-187 U-230 U-232 U-233 (F) U-234 U-235 (F) U-236 U-238 U-Natural U-Enriched (F) U-Depleted V-48 V-49 Y-91m Y-91 Y-92 Y-93	IV IV IV II I II II III II III III III III IV III III III IV IV

 

¹ Atomic number shown in parentheses.

² Atomic mass number shown after the element symbol.

^m Mestastable state.

^(F) Fissile material.

Element1	Radionuclide2	Group
Xenon (54)	Xe-125 Xe-131m Xe-131m (uncompressed) 3 Xe-133 Xe-133 (uncompressed) 3 Xe-135 Xe-135 (uncompressed) 3	III III   V III   VI   II   V
Ytterbium (70) Yttrium (39)   Zinc (30)       Zirconium (40)	Yb-175 Y-88 Y-90 (uncompressed) 3 Zn-65 Zn-69m Zn-69 Zr-93 Zr-95 Zr-97	IV III IV IV IV IV IV III IV

 

¹ Atomic number shown in parentheses.

² Atomic mass number shown after the element symbol.

³ Uncompressed means at a pressure not exceeding 1 atmosphere.

^m Mestastable state.

TABLE B

 

TESTS FOR SPECIAL FORM LICENSED MATERIAL

 

1. Free Drop - A free drop through a distance of 30 feet onto a flat essentially unyielding horizontal surface, striking the surface in such a position as to suffer maximum damage.

2. Percussion - Impact of the flat circular end of a 1 inch diameter steel rod weighing 3 pounds, dropped through a distance of 40 inches. The capsule or material shall be placed on a sheet of lead, of hardness number 3.5 to 4.5 on the Vickers scale, and not more than 1 inch thick, supported by a smooth essentially unyielding surface.

3. Heating - Heating in air to a temperature of 1,475 E F and remaining at that temperature for a period of 10 minutes.

4. Immersion - Immersion for 24 hours in water at room temperature. The water shall be a pH 6 - pH 8, with a maximum conductivity of 10 micromhos per centimeter.

(1) This subchapter provides for the registration of radiation machine facilities.

(2) In addition to the requirements of this subchapter, all registrants are subject to the applicable provisions of other rules of this chapter.

(1) For purposes of this subchapter "facility" means the location at which 1 or more devices or sources are installed and/or located within 1 building, vehicle, or under 1 roof and are under the same administrative control.

(1) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from the registration and notification requirements of this subchapter, providing dose equivalent rate averaged over an area of 10 square centimeters does not exceed 0.5 mrem per hour at 5 cm from any accessible surface of such equipment. The production, testing, or factory servicing or such equipment shall not be exempt.

(2) Radiation machines while in transit or storage incident thereto are exempt from the requirements of this subchapter.

(3) Domestic television receivers are exempt from the requirements of this subchapter.

(1) The owner or person having possession of any radiation machine shall:

(a) Register such machine with the department within 30 days following the effective date of this chapter or after acquisition of such machine and prior to its use. Registration shall be on forms available from the department.

(b) Designate an individual who will be responsible for radiation protection for the machine. Such individuals shall:

(i) be qualified by training and experience concerning all hazards and precautions involved in operating the machine for which he is responsible;

(ii) upon request by the department provide a detailed program of radiation safety for effective compliance with the applicable requirements of this chapter;

(iii) give instructions concerning hazards and safety practices to individuals who may be occupationally exposed to radiation from the machine; and

(iv) make surveys and carry out other procedures as required by this chapter.

(c) When, in the opinion of the department, the individual designated to be responsible for radiation safety does not have qualifications sufficient to insure such safety, the department may order the registrant to designate another individual who meets the requirements of this subsection.

(2) The registrant shall notify the department within 10 days after any change which renders the information on the registration no longer accurate.

(3) The owner or person having possession of any registered radiation machine shall re-register such machine with the department every 2 years as long as the activity requiring such registration continues.

(4) No person, in any advertisement, shall refer to the fact that a radiation machine is registered with the department and no person shall state or imply that any activity under such registration has been approved by the department.

(5) Whenever a manufacturer, his agent or a dealer sells or transfers title to a radiation machine, said manufacturer, his agent or the dealer shall give written notification thereof to the department. Written notification shall be given within 15 days of such sale or transfer of title and shall include the name and address of the new owner or owners.

(6) Whenever an owner sells, transfers title, or disposes of a radiation machine, said owner shall give written notification thereof to the department. This written notification shall be given within 15 days of such sale, transfer of title, or disposal, and shall include the name and address of the owner and details of the final disposal of the machine.

(1) Whenever any radiation machine is to be brought into Montana, for any temporary use, the person proposing to bring such machine into Montana shall give written notice to the department at least 2 working days before such machine is to be used in Montana. The notice shall include:

(a) the type of radiation machine;

(b) the nature, duration, and scope of use; and

(c) the exact location(s) where the radiation machine is to be used.

(2) If, for a specific case, the 2 working-day period would impose an undue hardship on the person, upon application to the department, permission to proceed sooner may be granted.

(3) The person referred to in (1) of this rule shall:

(a) comply with all applicable rules of the department;

(b) supply the department with such other information as the department may reasonably request; and

(c) not operate within Montana on a temporary basis in excess of 180 calendar days per year.

(1) This subchapter provides for the licensing of radioactive material. No person shall receive, possess, use, transfer, or acquire radioactive material except as authorized in a specific or general license issued pursuant to this subchapter or as otherwise provided in this subchapter.

(2) In addition to the requirements of this subchapter, all licensees are subject to the requirements of ARM Title 37, chapter 14, subchapters 1, 7 and 17. Licensees engaged in industrial radiographic operations are subject to the requirements of ARM Title 37, chapter 14, subchapter 8, and licensees using sealed sources in the healing arts are subject to the requirements of ARM Title 37, chapter 14, subchapter 11.

(1) Any person is exempt from this subchapter to the extent that such person receives, possesses, uses, or transfers source material in any chemical mixture, compound, solution, or alloy in which the source material is by weight less than 1/20 of 1% (0.05%) of the mixture, compound, solution, or alloy.

(2) Any person is exempt from this subchapter to the extent that such person receives, possesses, uses, or transfers unrefined and unprocessed ore containing source material; provided that, except as authorized in a specific license, such person shall not refine or process such ore.

(3) Any person is exempt from this subchapter to the extent that such person receives, possesses, uses, or transfers:

(a) any quantities of thorium contained in:

(i) incandescent gas mantles,

(ii) vacuum tubes,

(iii) welding rods,

(iv) electric lamps for illuminating purposes provided that each lamp does not contain more than 50 milligrams of thorium,

(v) germicidal lamps, sunlamps, and lamps for outdoor or industrial lighting provided that each lamp does not contain more than 2 grams of thorium,

(vi) rare earth metals and compounds, mixtures, and products containing not more than 0.25% by weight thorium, uranium, or any combination of these, or

(vii) personnel neutron dosimeters, provided that each dosimeter does not contain more than 50 milligrams of thorium;

(b) source material contained in the following products:

(i) glazed ceramic tableware, provided that the glaze contains not more than 20% by weight source material,

(ii) glassware, glass enamel and glass enamel frit containing not more than 10% by weight source material, but not including commercially manufactured glass brick, pane glass, ceramic tile or other glass, glass enamel or ceramic used in construction, or

(iii) piezoelectric ceramic containing not more than 2% by weight source material;

(c) photographic film, negatives, and prints containing uranium or thorium;

(d) any finished product or part fabricated of, or containing, tungsten-thorium or magnesium-thorium alloys, provided that the thorium content of the alloy does not exceed 4% by weight and that this exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such product or part;

(e) uranium contained in counterweights installed in aircraft, rockets, projectiles, and missiles, or stored or handled in connection with installation or removal of such counterweights, provided that

(i) the counterweights are manufactured in accordance with a specific license issued by the US nuclear regulatory commission, authorizing distribution by the licensee pursuant to 10 CFR Part 40,

(ii) each counterweight has been impressed with the following legend clearly legible through any plating or other covering: "DEPLETED URANIUM". The requirements specified in (3) (e) (ii) and (iii) of this rule need not be met by counterweights manufactured prior to December 31, 1969; provided, that such counterweights are impressed with the legend "CAUTION--RADIOACTIVE MATERIAL--URANIUM", as previously required by this chapter.

(iii) each counterweight is durably and legibly labeled or marked with the identification of the manufacturer and the statement: "UNAUTHORIZED ALTERATIONS PROHIBITED", and

(iv) this exemption shall not be deemed to authorize the chemical, physical, or metallurgical treatment or processing of any such counterweights other than repair or restoration of any plating or other covering;

(f) uranium used as shielding constituting part of any shipping container which is conspicuously and legibly impressed with the legend "CAUTION--RADIOACTIVE SHIELDING--URANIUM" and which meets the specifications for containers for radioactive material prescribed in 49 CFR Part 173, section 173.394 or 173.395, of the US department of transportation regulations;

(g) thorium contained in finished optical lenses, provided that each lens does not contain more than 30% by weight of thorium, and that this exemption shall not be deemed to authorize either:

(i) the shaping, grinding, or polishing of such lens or manufacturing processes other than the assembly of such lens into optical systems and devices without any alteration of the lens, or

(ii) the receipt, possession, use, or transfer of thorium contained in contact lenses, or in spectacles, or in eyepieces in binoculars or other optical instruments;

(h) uranium contained in detector heads for use in fire detection units, provided that each detector head contains not more than 0.005 microcurie of uranium; or

(i) thorium contained in any finished aircraft engine part containing nickel-thoria alloy, provided that

(i) the thorium is dispersed in the nickel-thoria alloy in the form of finely divided thoria (thorium dioxide) , and

(ii) the thorium content in the nickel-thoria alloy does not exceed 4% by weight.

(4) The exemptions in (3) of this rule do not authorize the manufacture of any of the products described.

(1) (a) Except as provided in (b) below, any person is exempt from this subchapter to the extent that such person receives, possesses, uses, transfers, or acquires products or materials containing radioactive material in concentrations not in excess of those listed in Schedule A of this subchapter, with the exception of radium 226 for which the exempt concentration is 5 x 10^-6 mCi/ml (u Ci/gm) .

(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 (a) above or equivalent regulations of the US nuclear regulatory commission, any agreement state or licensing state, except in accordance with a specific license issued pursuant to ARM 37.14.542(1) or the general license provided in ARM 37.14.551.

(2) (a) Except as provided in (c) and (d) below, any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in Schedule B of this subchapter.

(b) ARM 37.14.506(2) 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 of this subchapter, knowing or having reason to believe that such quantities of radioactive material will be transferred to persons exempt under (2) of this rule or equivalent regulations of the US nuclear regulatory commission, any agreement state or licensing state, except in accordance with a specific license issued by the US nuclear regulatory commission pursuant to 10 CFR Part 32, section 32.18 or by the department pursuant to ARM 37.14.542(2) which license states that the radioactive material may be transferred by the licensee to persons exempt under (2) or the equivalent regulations of the US nuclear regulatory commission, any agreement state or licensing state.

(3) Except for persons who apply radioactive material to, or persons who incorporate radioactive material into the following products, any person is exempt from this subchapter to the extent that he receives, possesses, uses, transfers, 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 US Nuclear Regulatory Commission, Washington, DC 20555.)

(a) Timepieces or hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified levels of radiation:

(i) 25 millicuries of tritium per timepiece.

(ii) 5 millicuries of tritium per hand.

(iii) 15 millicuries of tritium per dial (bezels when used shall be considered as part of the dial) .

(iv) 100 microcuries of promethium-147 per watch or 200 microcuries of promethium-147 per any other timepiece.

(v) 20 microcuries of promethium-147 per watch hand or 40 microcuries of promethium-147 per other timepiece hand.

(vi) 60 microcuries of promethium-147 per watch dial or 120 microcuries of promethium-147 per other timepiece dial (bezels when used shall be considered as part of the dial) .

(vii) The levels of radiation from hands and dials containing promethium-147 will not exceed, when measured through 50 milligrams per square centimeter of absorber:

(A) For wrist watches, 0.1 millirad per hour at 10 centimeters from any surface.

(B) For pocket watches, 0.1 millirad per hour at 1 centimeter from any surface.

(C) For any other timepiece, 0.2 millirad per hour at 10 centimeters from any surface.

(viii) One microcurie of radium-226 per timepiece in timepieces acquired prior to the effective date of this chapter.

(b) Lock illuminators containing not more than 15 millicuries of tritium or not more than 2 millicuries of promethium-147 installed in automobile locks. The levels of radiation from each lock illuminator containing promethium-147 will not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 50 milligrams per square centimeter of absorber.

(c) Precision balances containing not more than 1 millicurie of tritium per balance or not more than 0.5 millicurie of tritium per balance part.

(d) Automobile shift quadrants containing not more than 25 millicuries of tritium.

(e) Marine compasses containing not more than 750 millicuries of tritium gas and other marine navigational instruments containing not more than 250 millicuries of tritium gas.

(f) Thermostat dials and pointers containing not more than 25 millicuries of tritium per thermostat.

(g) Electron tubes; provided, that each tube does not contain more than 1 of the following specified quantities of byproduct material:

(i) 150 millicuries of tritium per microwave receiver protector tube or 10 millicuries of tritium per any other electron tube.

(ii) 1 microcurie of cobalt-60.

(iii) 5 microcuries of nickel-63.

(iv) 30 microcuries of krypton-85.

(v) 5 microcuries of cesium-137.

(vi) 30 microcuries of promethium-147.

And provided further, that the levels of radiation from each electron tube containing byproduct material do not exceed 1 millirad per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber. For purposes of (g) , "electron tubes" include 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.

(h) Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, a source of radioactive material not exceeding the applicable quantity set forth in Schedule B of this subchapter.

(i) Spark gap irradiators containing not more than 1 microcurie of cobalt-60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least 3 gallons (11.4 liters) per hour.

(4) (a) Except for persons who manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, or acquires tritium, krypton-85 or promethium-147 in self-luminous products manufactured, processed, produced, imported, or transferred in accordance with a specific license issued by the US nuclear regulatory commission pursuant to 10 CFR Part 32, section 32.22, which license authorizes the transfer of the product to persons who are exempt from regulatory requirements. The exemption in (a) does not apply to tritium, krypton-85, or promethium-147 used in products for frivolous purposes or in toys or adornments.

(b) Any person is exempt from this chapter to the extent that such person receives, possesses, uses, or transfers articles containing less than 0.1 microcurie of radium-226 which were acquired prior to the effective date of this chapter.

(5) (a) Except for persons who manufacture, process, or produce gas and aerosol detectors containing radioactive material, any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fire and airborne hazards provided that detectors containing radioactive material shall have been manufactured, imported, or transferred in accordance with a specific license issued by the US nuclear regulatory commission pursuant to 10 CFR Part 32, section 32.26; or a licensing state pursuant to ARM 37.14.542(3) which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements. 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 US Nuclear Regulatory Commission, Washington, DC 20555.

(b) Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an agreement state shall be considered exempt under (a) above, provided that the device is labeled in accordance with the specific license authorizing distribution of the generally licensed device, and provided further that they meet the requirements of ARM 37.14.542(3) .

(c) Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific license issued by a licensing state shall be considered exempt under (a) above, provided that the device is labeled in accordance with the specific license authorizing distribution, and provided further that they meet the requirements of ARM 37.14.542(3) .

(6) Any person is exempt from this chapter to the extent that such person receives, possesses, uses, transfers, or acquires synthetic plastic resins containing scandium-46 which are designed for sand consolidation in oil wells. Such resins shall have been manufactured or imported in accordance with a specific license issued by the US nuclear regulatory commission, or shall have been manufactured in accordance with the specifications contained in a specific license issued by the department or any agreement state to the manufacturer of such resins pursuant to licensing requirements equivalent to those in 10 CFR Part 32, sections 32.16 and 32.17, of the regulations of the US nuclear regulatory commission. This exemption does not authorize the manufacture of any resins containing scandium-46.

(1) Licenses for radioactive materials are of 2 types: general and specific. General licenses provided in this subchapter are effective without the filing of applications with the department or the issuance of licensing documents to the particular persons, although the filing of a certificate with the department may be required by the particular general license. The general license is subject to all other applicable portions of this chapter and any limitations of the general license.

(2) Specific licenses require the submission of an application to the department and the issuance of a licensing document by the department. The licensee is subject to all applicable portions of this chapter as well as any limitations specified in the licensing document.

(1) A general license is hereby issued authorizing use and transfer of not more than 15 pounds of source material at any 1 time by persons in the following categories:

(a) Pharmacists using the source material solely for the compounding of medicinals.

(b) Physicians using the source material for medicinal purposes.

(c) Persons receiving possession of source material from pharmacists and physicians in the form of medicinals or drugs.

(d) Commercial and industrial firms, and research, educational, and medical institutions, and state and local governmental agencies for research, development, educational, commercial or operational purposes.

(e) And provided, that no such person shall, pursuant to this general license, receive more than a total of 150 pounds of source material in any 1 calendar year.

(2) Persons who receive, possess, use, or transfer source material pursuant to the general license issued in (1) of this rule are exempt from the provisions of ARM Title 37, chapter 14, subchapters 7 and 17, to the extent that such receipt, possession, use, or transfer is within the terms of such general license; provided, however, that this exemption shall not be deemed to apply to any such person who is also in possession of source material under a specific license issued pursuant to this subchapter.

(3) A general license is hereby issued authorizing the receipt of title to source material without regard to quantity. This general license does not authorize any person to receive, possess, use, or transfer source material.

(4) (a) A general license is hereby issued to receive, acquire, possess, use, or transfer, in accordance with the provisions of (b) through (e) below, depleted uranium contained in industrial products or devices for the purpose of providing a concentrated mass in a small volume of the product or device.

(b) The general license in (a) above applies only to industrial products or devices which have been manufactured either in accordance with a specific license issued to the manufacturer of the products or devices pursuant to ARM 37.14.542(13) or in accordance with a specific license issued to the manufacturer by the US nuclear regulatory commission or an agreement state which authorizes manufacture of the products or devices for distribution to persons generally licensed by the US nuclear regulatory commission or an agreement state.

(c) (i) Persons who receive, acquire, possess, or use depleted uranium pursuant to the general license established by (a) above shall file department form MRH-12, "Registration Certificate--Use of Depleted Uranium Under General License", with the department. The form shall be submitted within 30 days after the first receipt or acquisition of such depleted uranium. The registrant shall furnish on department form MRH-12 the following information and such other information as may be required by that form:

(A) name and address of the registrant;

(B) a statement that the registrant has developed and will maintain procedures designed to establish physical control over the depleted uranium described in (a) above and designed to prevent transfer of such depleted uranium in any form, including metal scrap, to persons not authorized to receive the depleted uranium; and

(C) name and/or title, address, and telephone number of the individual duly authorized to act for and on behalf of the registrant in supervising the procedures identified in (B) above.

(ii) The registrant possessing or using depleted uranium under the general license established by (a) above shall report in writing to the department any changes in information furnished by him in department form MRH-12, "Registration Certificate--Use of Depleted Uranium Under General License". The report shall be submitted within 30 days after the effective date of such change.

(d) A person who receives, acquires, possesses, or uses depleted uranium pursuant to the general license established by (a) above:

(i) Shall not introduce such depleted uranium, in any form, into a chemical, physical, or metallurgical treatment or process, except a treatment or process for repair or restoration of any plating or other covering of the depleted uranium.

(ii) Shall not abandon such depleted uranium.

(iii) Shall transfer or dispose of such depleted uranium only by transfer in accordance with the provisions of ARM 37.14.547. In the case where the transferee receives the depleted uranium pursuant to the general license established by (a) above, the transferor shall furnish the transferee a copy of this rule and a copy of department form MRH-12. In the case where the transferee receives the depleted uranium pursuant to a general license contained in the US nuclear regulatory commission's or agreement state's regulation equivalent to (a) above, the transferor shall furnish the transferee a copy of this rule and a copy of department form MRH-12 accompanied by a note explaining that use of the product or device is regulated by the US nuclear regulatory commission or agreement state under requirements substantially the same as those in this rule.

(iv) Within 30 days of any transfer, shall report in writing to the department the name and address of the person receiving the depleted uranium pursuant to such transfer.

(v) Shall not export such depleted uranium except in accordance with a license issued by the US nuclear regulatory commission pursuant to 10 CFR Part 110.

(e) Any person receiving, acquiring, possessing, using, or transferring depleted uranium pursuant to the general license established by (a) above is exempt from the requirements of ARM Title 37, chapter 14, subchapters 7 and 17, with respect to the depleted uranium covered by that general license.

(1) A general license is hereby issued to transfer, receive, acquire, 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 US nuclear regulatory commission for use pursuant to 10 CFR Part 31, section 31.3. This general license is subject to the provisions of ARM 37.14.107, 37.14.108, 37.14.115, 37.14.116, 37.14.506(1) (b) , 37.14.526, 37.14.547, 37.14.550, 37.14.552, and Title 37, chapter 14, subchapters 7 and 17.

(a) 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 of polonium-210 per device.

(b) 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 of polonium-210 per device or a total of not more than 50 millicuries of hydrogen-3 (tritium) per device.

(4) (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 business, and state or local government agencies to receive, acquire, possess, use, or transfer in accordance with the provisions of (b) through (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) The general license in (a) above applies only to radioactive material contained in devices which have been manufactured and labeled in accordance with the specifications contained in a specific license issued by the department pursuant to ARM 37.14.542(4) or in accordance with the specifications contained in a specific license issued by the US nuclear regulatory commission, an agreement state or a licensing state, which authorizes distribution of devices to persons generally licensed by the US nuclear regulatory commission, an agreement state or a licensing state.

(c) Any person who receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general license in (a) above:

(i) 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;

(ii) 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 of other beta and/or gamma emitting material or 10 microcuries of alpha emitting material and devices held in storage in the original shipping container prior to initial installation need not be tested for any purpose;

(iii) shall assure that the tests required by (ii) above and other testing, installation, servicing, and removal from installation involving the radioactive materials, 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 US nuclear regulatory commission, an agreement state or a licensing state to perform such activities;

(iv) shall maintain records showing compliance with the requirements of (ii) and (iii) 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, installing, servicing, and removing from installation concerning the radioactive material, its shielding or containment. Records of tests for leakage of radioactive material required by (ii) above shall be maintained for 1 year after the next required leak test is performed or until the sealed source is transferred or disposed of. Records of tests of the on/off mechanism and indicator required by (ii) above shall be maintained for 1 year after the next required test of the on/off mechanism and indicator is performed or until the sealed source is transferred or disposed of. Records which are required by (iii) above shall be maintained for a period of 2 years from the date of the recorded event or until the device is transferred or disposed of;

(v) 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 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 US 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;

(vi) shall not abandon the device containing radioactive material;

(vii) except as provided in (viii) below, shall transfer or dispose of the device containing radioactive material only by transfer to a specific licensee of the department, the US nuclear regulatory commission, an agreement state, or a licensing state whose specific license authorizes him to receive the device and within 30 days after transfer of a device to a specific licensee shall furnish to the department a report containing identification of the device by manufacturer's name and model number and the name and address of the person receiving the device. No report is required if the device is transferred to the specific licensee in order to obtain a replacement device;

(viii) shall transfer the device to another general licensee:

(A) where the device remains in use at a particular location. In such case the transferor shall give the transferee a copy of this rule 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 name and model number of device transferred, the name and address of the transferee, and the name and/or position of an individual who may constitute a point of contact between the department and the transferee; 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

(ix) shall comply with the provisions of ARM 37.14.751 and 37.14.755, for reporting radiation incidents, theft, or loss of licensed material, but shall be exempt from the other requirements of ARM Title 37, chapter 14, subchapters 7 and 17.

(d) The general license in (a) above does not authorize the manufacture of devices containing radioactive material.

(e) The general license provided in (a) above is subject to the provisions of ARM 37.14.107, 37.14.108, 37.14.115, 37.14.116 and 37.14.526, 37.14.547, 37.14.550, and 37.14.552.

(5) (a) A general license is hereby issued to receive, acquire, possess, and use tritium or promethium-147 contained in luminous safety devices for use in aircraft, provided:

(i) each device contains not more than 10 curies of tritium or 300 millicuries of promethium-147; and

(ii) each device has been manufactured, assembled or imported in accordance with a specific license issued by the US 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.

(b) Persons who receive, acquire, possess, or use luminous safety devices pursuant to the general license in (a) above are exempt from the requirements of ARM Title 37, chapter 17, subchapters 7 and 17, except that they shall comply with the provisions of ARM 37.14.751 and 37.14.755.

(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 ARM 37.14.107, 37.14.108, 37.14.115, 37.14.116, 37.14.526, 37.14.547, 37.14.550, and 37.14.552.

(6) A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this subchapter, this general license does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material.

(7) (a) A general license is hereby issued to those persons listed below to receive, acquire, possess, use, and transfer, in accordance with the provisions of (d) and (e) below, americium-241 in the form of calibration or reference sources:

(i) any person who holds a specific license issued by the department which authorizes him to receive, possess, use, and transfer radioactive material; and

(ii) any person who holds a specific license issued by the US nuclear regulatory commission which authorizes him to receive, possess, use, and transfer special nuclear material.

(b) A general license is hereby issued to receive, possess, use, and transfer plutonium in the form of calibration or reference sources in accordance with the provisions of (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 receive, possess, use, and transfer radium-226 in the form of calibration or reference sources in accordance with the provisions of (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 (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 US nuclear regulatory commission or which have been manufactured in accordance with the specification contained in a specific license issued to the manufacturer by the department, any agreement state or licensing state.

(e) The general licenses provided in (a) , (b) , and (c) above are subject to the provisions of ARM 37.14.107, 37.14.108, 37.14.115, 37.14.116, 37.14.526, 37.14.547, 37.14.550, 37.14.552, and Title 37, chapter 14, subchapters 7 and 17. In addition, persons who receive, acquire, possess, use, or transfer 1 or more calibration or reference sources pursuant to these general licenses:

( i ) shall not possess at any 1 time, at any 1 location of storage or use, more than 5 microcuries of americium-241, 5 microcuries of plutonium, or 5 microcuries of radium-226 in such sources;

(ii) shall not receive, possess, use, or transfer such source unless the source, or the storage container, bears a label which includes 1 of the following statements, as appropriate, or a substantially similar statement which contains the information called for in 1 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 US 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 or PLUTONIUM--show only the name of the appropriate material.)

DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.

                                                                                                                                                                

                                                                         Name of manufacturer of importer

 

(B) The receipt, possession, use and transfer of this source, Model                      ,

Serial No.                   , are subject to a general license and the regulations of any 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

 

(iii) shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the department, the US nuclear regulatory commission, an agreement state or a licensing state to receive the source;

(iv) 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

(v) 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.

(8) (a) A general license is hereby 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 (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 ARM 37.14.542(7) , or by the US nuclear regulatory commission, any agreement state or a licensing state pursuant to equivalent regulations authorizing distribution to persons generally licensed pursuant to (8) or its equivalent:

( i ) iodine-131 as sodium iodide (Na¹³¹I) for measurement of thyroid uptake;

(ii) iodine-131 as iodinated human serum albumin (IHSA) for determinations of blood and blood plasma volume;

(iii) iodine-125 as iodinated human serum albumin (IHSA) for determinations of blood and blood plasma volume;

(iv) ( reserved )

(v) cobalt-58 for the measurement of intestinal absorption of cyanocobalamin ;

(vi) cobalt-60 for the measurement of intestinal absorption of cyanocobalamin ; and

(vii) chromium-51 as sodium radiochromate for determination of red blood cell volumes and studies of red blood cell survival time.

(b) No physician shall receive, possess, use, or transfer radioactive material pursuant to the general license established by (a) above until he has filed department form MRH-10, "Certificate--Medical Use of Radioactive Material Under General License" with the department and received from the department a validated copy of the department form MRH-10 with certification number assigned. The generally licensed physician shall furnish on department form MRH-10 the following information and such other information as may be required by that form:

(i) name and address of the generally licensed physician;

(ii) a statement that the generally licensed physician is a duly licensed physician (authorized to dispense drugs) in the practice of medicine in Montana; and

(iii) a statement that the generally licensed physician has appropriate radiation measuring instruments to carry out the diagnostic procedures for which he proposes to use radioactive material under the general license of this (8) and that he is competent in the use of such instruments.

(c) A physician who receives, possesses, or uses a pharmaceutical containing radioactive material pursuant to the general license established by (a) above shall comply with the following:

(i) He shall not possess at any 1 time, pursuant to the general license in (a) above more than:

(A) 200 microcuries of iodine-131,

(B) 200 microcuries of iodine-125,

(C) 5 microcuries of cobalt-57,

(D) 5 microcuries of cobalt-58,

(E) 5 microcuries of cobalt-60, and

(F) 200 microcuries of chromium-51;

(ii) he shall store the pharmaceutical in the original shipping container, or a container providing equivalent radiation protection until administered;

(iii) he shall use the pharmaceutical only for the uses authorized by (a) above;

(iv) he shall not administer the pharmaceutical to a woman with confirmed pregnancy or to a person under 18 years of age; and

(v) he 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 US nuclear regulatory commission, any 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 generally licensed physician possessing or using radioactive material under the general license of (a) above shall report in duplicate to the department, any changes in the information furnished by him in the "Certificate--Medical Use of Radioactive Material Under General License", department form MRH-10. 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 (a) above is exempt from the requirements of ARM Title 37, chapter 14, subchapters 7 and 17, with respect to the radioactive material covered by the general license.

(9) (a) A general license is hereby issued to any physician, clinical laboratory or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests, in accordance with the provisions of (b) through (f) below, the following radioactive materials in prepackaged units:

(i) Iodine-125, in units not exceeding 10 microcuries each 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.

(ii) Iodine-131, in units not exceeding 10 microcuries each 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.

(iii) Carbon-14, in units not exceeding 10 microcuries each 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.

(iv) Hydrogen-3 (tritium) , in units not exceeding 50 microcuries each 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.

(v) Iron-59, in units not exceeding 20 microcuries each 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.

(vi) Cobalt-57, in units not exceeding 10 microcuries each 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.

(vii) Selenium-75, in units not to exceed 10 microcuries each 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.

(viii) Mock Iodine-125 reference or calibration sources, in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each 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.

(b) No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general license established by (a) above until he has filed department form MRH-11, "Certificate--In Vitro Testing with Radioactive Material Under General License", with the department and received from the department a validated copy of department form MRH-11 with certification number assigned, or until he has been authorized pursuant to ARM 37.14.540(3) (c) to use radioactive material under the general license in (9) . The physician, clinical laboratory or hospital shall furnish on department form MRH-11 the following information and such other information as may be required by that form:

(i) name and address of the physician, clinical laboratory or hospital;

(ii) the location of use; and

(iii) a statement that the physician, clinical laboratory or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive material as authorized under the general license in (a) above and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive material.

(c) A person who receives, acquires, possesses or uses radioactive material pursuant to the general license established by (a) above shall comply with the following:

(i) The general licensee shall not possess at any 1 time, pursuant to the general license in (a) above, at any 1 location of storage or use, a total amount of iodine-125, iodine-131, selenium-75, iron-59, and/or cobalt-57 in excess of 200 microcuries.

(ii) The general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection.

(iii) The general licensee shall use the radioactive material only for the uses authorized by (a) above.

(iv) 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 US nuclear regulatory commission, any 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.

(v) The general licensee shall dispose of the mock iodine-125 reference or calibration sources described in (a) (viii) above as required by ARM 37.14.740.

(d) The general licensee shall not receive, acquire, possess, or use radioactive material pursuant to (a) above:

(i) Except as prepackaged units which are labeled in accordance with the provisions of an applicable specific license issued pursuant to ARM 37.14.542(8) in accordance with the provisions of a specific license issued by the US nuclear regulatory commission, any 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 generally licensed under (9) or its equivalent, and

(ii) unless 1 of the following statements, as appropriate, or a substantially similar statement which contains the information called for in 1 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, 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 US nuclear regulatory commission or of a state

with which the commission has entered into an agreement for the exercise of regulatory authority.

                                                                                                                                                             

                                                                       Name of manufacturer

 

(B) This radioactive material shall be received, acquired, possessed, and used only by

physicians, 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

 

(e) The physician, clinical laboratory or hospital possessing or using radioactive material under the general license of (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", department form MRH-11. 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 (a) above is exempt from the requirements of ARM Title 37, chapter 14, subchapters 7 and 17, with respect to radioactive material covered by that general license, except that such persons using the mock iodine-125 described in (a) (viii) above shall comply with the provisions of ARM 37.14.740, 37.14.751, and 37.14.755.

(10) (a) A general license is hereby issued to receive, acquire, possess, use, and transfer strontium-90 contained in ice detection devices, provided each device contains not more than 50 microcuries of strontium-90 and each device has been manufactured or imported in accordance with a specific license issued by the US nuclear regulatory commission or each device has been manufactured in accordance with the specifications contained in a specific license issued by the department or any agreement state to the manufacturer of such device.

(b) Persons who receive, acquire, possess, use, or transfer strontium-90 contained in ice detection devices pursuant to the general license in (a) above:

(i) 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 US nuclear regulatory commission or an agreement state to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of ARM 37.14.740.

(ii) 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

(iii) are exempt from the requirements of ARM Title 37, chapter 14, subchapters 7 and 17, except that such persons shall comply with the provisions of ARM 37.14.740, 37.14.751, and 37.14.755.

(c) This general license does not authorize the manufacture, assembly, disassembly or repair of strontium-90 in ice detection devices.

(d) This general license is subject to the provisions of ARM 37.14.107, 37.14.108, 37.14.115, 37.14.116, 37.14.526, 37.14.547, 37.14.550, and 37.14.552.

(1) A general license is hereby issued to any common or contract carrier to transport and store radioactive material in the regular course of their carriage for another or storage incident thereto, provided the transportation and storage is in accordance with the applicable requirements of the regulations, appropriate to the mode of transport, of the US department of transportation insofar as such regulations relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting. Any notification of incidents referred to in those requirements shall be filed with, or made to, the department. Persons who transport and store radioactive material pursuant to the general license in this subsection are exempt from the requirements of ARM Title 37, chapter 14, subchapters 7 and 17.

(2) A general license is hereby issued to any private carrier to transport radioactive material, provided the transportation is in accordance with the applicable requirements of the regulations, appropriate to the mode of transport, of the US department of transportation insofar as such regulations relate to the loading and storage of packages, placarding of the transporting vehicle, and incident reporting. Any notification of incidents referred to in those requirements shall be filed with, or made to, the department.

(a) Persons who transport radioactive material pursuant to the general license in (2) are exempt from the requirements of ARM Title 37, chapter 14, subchapters 7 and 17, to the extent that they transport radioactive material.

(b) Physicians, as defined in ARM 37.14.102 are exempt from the requirements of (2) to the extent that they transport radioactive material for use in the practice of medicine.

(1) Applications for specific licenses shall be filed on a form prescribed by the department.

(2) The department may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the department to determine whether the application should be granted or denied or whether a license should be modified or revoked.

(3) Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf.

(4) An application for a license may include a request for a license authorizing 1 or more activities.

(5) In his application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the department provided such references are clear and specific.

A license application will be approved if the department determines that:

(1) the applicant is qualified by reason of training and experience to use the material in question for the purpose requested in accordance with this chapter in such a manner as to minimize danger to public health and safety or property;

(2) the applicant's proposed equipment, facilities, and procedures are adequate to minimize danger to public health and safety or property;

(3) the issuance of the license will not be inimical to the health and safety of the public; and

(4) the applicant satisfies any applicable special requirements in ARM 37.14.540, 37.14.541, or 37.14.542.

(1) Upon a determination that an application meets the requirements of the act and the rules of the department, the department will issue a specific license authorizing the proposed activity in such form and containing such conditions and limitations as it deems appropriate or necessary.

(2) The department may incorporate in any license at the time of issuance, or thereafter by appropriate rule, regulation, or order, such additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of radioactive material subject to this subchapter as it deems appropriate or necessary in order to:

(a) minimize danger to public health and safety or property;

(b) require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be appropriate or necessary; and

(c) prevent loss or theft of material subject to this subchapter.

(1) Each license issued pursuant to this subchapter shall be subject to all the provisions of the act, now or hereafter in effect, and to all rules, regulations, and orders of the department.

(2) No license issued or granted under this subchapter and no right to possess or utilize radioactive material granted by any license issued pursuant to this subchapter shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the department shall, after securing full information find that the transfer is in accordance with the provisions of the act, and shall give its consent in writing.

(3) Each person licensed by the department pursuant to this subchapter shall confine his use and possession of the material licensed to the locations and purposes authorized in the license.

(1) Except as provided in ARM 37.14.528(2) , each specific license shall expire at the end of the day, in the month and year stated therein.

(1) Applications for renewal of specific licenses shall be filed in accordance with ARM 37.14.520.

(2) In any case in which a licensee, not less than 30 days prior to expiration of his existing license, has filed an application in proper form for renewal or for a new license authorizing the same activities, such existing license shall not expire until the application has been finally determined by the department.

(1) Applications for amendment of a license shall be filed in accordance with ARM 37.14.520 and shall specify the respects in which the licensee desires his license to be amended and the grounds for such amendment.

(1) In considering an application by a licensee to renew or amend his license, the department will apply the criteria set forth in ARM 37.14.521, 37.14.540, 37.14.541 or 37.14.542, as applicable.

(1) In addition to the requirements set forth in ARM 37.14.521, a specific license for human use of radioactive material in institutions will be issued if:

(a) the applicant has appointed a medical isotopes committee of at least 3 members to evaluate all proposals for research, diagnostic, and therapeutic use of radioactive material within that institution. Membership of the committee should include physicians expert in internal medicine, hematology, therapeutic radiology, and a person experienced in assay of radioactive material and protection against radiation;

(b) the applicant possesses adequate facilities for the clinical care of patients;

(c) the physician designated on the application as the individual user has substantial experience in the handling and administration of radioactive material and, where applicable, the clinical management of radioactive patients; and

(d) if the application is for a license to use unspecified quantities or multiple types of radioactive material, the applicant's staff has substantial experience in the use of a variety of radioactive materials for a variety of human uses.

(2) (a) An application by an individual physician or group of physicians for a specific license for human use of radioactive material will be approved if:

(i) the applicant satisfies the general requirements specified in ARM 37.14.521;

(ii) the application is for use in the applicant's practice in an office outside a medical institution;

(iii) the applicant has access to a hospital possessing adequate facilities to hospitalize and monitor the applicant's radioactive patients whenever it is advisable; and

(iv) the applicant has extensive experience in the proposed use, the handling and administration of radionuclides, and where applicable, the clinical management of radioactive patients.

(b) The department will not approve an application by an individual physician or group of physicians for a specific license to receive, possess, or use radioactive material on the premises of a medical institution unless:

(i) the use of radioactive material is limited to:

(A) the administration of radiopharmaceuticals for diagnostic or therapeutic purposes,

(B) the performance of diagnostic studies on patients to whom a radiopharmaceutical has been administered,

(C) the performance of in vitro diagnostic studies, or

(D) the calibration and quality control checks of radioactive assay instrumentation, radiation safety instrumentation and diagnostic instrumentation;

(ii) the physician brings the radioactive material with him and removes the radioactive material when he departs. (The institution cannot receive, possess, or store radioactive material other than the amount of material remaining in the patient) ; and

(iii) the medical institution does not hold a radioactive material license under (1) of this rule.

(3) (a) Subject to the provisions of (b) , (c) , and (d) below, an application for a specific license pursuant to (1) , (2) , or (4) of this rule for any medical use or uses of radioactive material specified in 1 or more of Groups I to VI, inclusive, of Schedule C of this subchapter will be approved for all of the uses within the group or groups which include the use or uses specified in the application if:

(i) the applicant satisfies the requirements of (1) , (2) , or (4) of this rule;

(ii) the applicant, or the physician designated in the application as the individual user, has adequate clinical experience in the types of uses included in the group or groups;

(iii) the applicant, or the physicians and all other personnel who will be involved in the preparation and use of the radioactive material, have adequate training and experience in the handling of radioactive material appropriate to their participation in the uses included in the group or groups;

(iv) the applicant's radiation detection and measuring instrumentation is adequate for conducting the procedures involved in the uses included in the group or groups; and

(v) the applicant's radiation safety operating procedures are adequate for handling and disposal of the radioactive material involved in the uses included in the group or groups.

(b) Any licensee or registrant who is authorized to use radioactive material pursuant to 1 or more groups in (a) above and Schedule C of this subchapter is subject to the following conditions:

(i) For groups I, II, IV, and V, no licensee or registrant shall receive, possess, or use radioactive material except as a radiopharmaceutical manufactured in the form to be administered to the patient, labeled, packaged, and distributed in accordance with a specific license issued by the department pursuant to ARM 37.14.542(10) , a specific license issued by the US nuclear regulatory commission, or a specific license issued by an agreement state or a licensing state pursuant to equivalent regulations.

(ii) For Group III, no licensee or registrant shall receive, possess, or use generators or reagent kits containing radioactive material or shall use reagent kits that do not contain radioactive material to prepare radiopharmaceuticals containing radioactive material, except:

(A) reagent kits not containing radioactive material that are approved by the department, the US nuclear regulatory commission, an agreement state or a licensing state for use by persons licensed pursuant to (3) and Schedule C of this subchapter or equivalent regulations; or

(B) generators or reagent kits containing radioactive material that are manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the department pursuant to ARM 37.14.542(11) , a specific license issued by the US nuclear regulatory commission, or a specific license issued by an agreement state or a licensing state pursuant to equivalent regulations.

(iii) For Group VI, no licensee or registrant shall receive, possess, or use radioactive material except as contained in a source or device that has been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the department pursuant to ARM 37.14.542(12) , a specific license issued by the US nuclear regulatory commission, or a specific license issued to the manufacturer by an agreement state or a licensing state pursuant to equivalent regulations.

(iv) For Group III, any licensee or registrant who uses generators or reagent kits shall elute the generator or process radioactive material with the reagent kit in accordance with instructions which are approved by the department, the US nuclear regulatory commission, an agreement state or a licensing state and are furnished by the manufacturer on the label attached to or in the leaflet or brochure which accompanies the generator or reagent kit.

(v) For Group VI any licensee who possesses and uses sources or devices containing radioactive material shall:

(A) cause each source or device containing more than 100 microcuries of radioactive material with a half-life greater than 30 days, except iridium-192 seeds encased in nylon ribbon, to be tested for contamination and/or leakage at intervals not to exceed 6 months or at such other intervals as are approved by the department, the US nuclear regulatory commission, an agreement state or a licensing state and described by the manufacturer on the label attached to the source, device, or permanent container thereof, or in the leaflet or brochure which accompanies the source or device. Each source or device shall be so tested prior to its first use unless the supplier furnishes a certificate that the source or device has been so tested within 6 months prior to the transfer;

(B) assure that the test required by (A) above shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample or in the case of radium, the escape of radon at the rate of 0.001 microcurie per 24 hours. The test sample shall be taken from the source or from the surfaces of the device in which the source is permanently or semi-permanently mounted or stored on which one might expect contamination to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the department;

(C) if the test required by (A) above reveals the presence of 0.005 microcurie or more of removable contamination or in the case of radium, the escape of radon at the rate of 0.001 microcurie per 24 hours, immediately withdraw the source from use and cause it to be decontaminated and repaired or to be disposed of in accordance with department rules. A report shall be filed within 5 days of the test with the department, describing the equipment involved, the test results, and the corrective action taken;

(D) follow the radiation safety and handling instructions approved by the department, the US nuclear regulatory commission, an agreement state or a licensing state and furnished by the manufacturer on the label attached to the source, device or permanent container thereof, or in the leaflet or brochure which accompanies the source or device, and maintain such instruction in a legible and conveniently available form;

(E) conduct a quarterly physical inventory to account for all sources and devices received and possessed. Records of the inventories shall be maintained for inspection by the department and shall include the quantities and kinds of radioactive material, location of sources and devices, and the date of the inventory;

(F) assure that needles or standard medical applicator cells containing radium-226, or cobalt-60 as wire are not opened while in the licensee's possession unless specifically authorized by a license issued to him by the department; and

(G) assure that patients containing cobalt-60, cesium-137, iridium-192 and/or radium-226 implants shall remain hospitalized until the implants are removed.

(c) Any licensee who is licensed pursuant to (3) (a) above for 1 or more of the medical use groups in Schedule C of this subchapter also is authorized to use radioactive material under the general license in ARM 37.14.512(9) for the specified in vitro uses without filing department form MRH-11 as required in ARM 37.14.512(9) (b) ; provided, that the licensee is subject to the other provisions of ARM 37.14.512(9) .

(d) Any licensee who is licensed pursuant to (3) (a) above for 1 or more of the medical use groups in Schedule C of this subchapter also is authorized, subject to the provisions of (d) and (e) below, to receive, possess, and use for calibration and reference standards:

(i) any radioactive material listed in Group I, Group II, or Group III of Schedule C of this subchapter with a half-life not longer than 100 days, in amounts not to exceed 15 millicuries total;

(ii) any radioactive material listed in Group I, Group II, or Group III of Schedule C of this subchapter with half-life greater than 100 days in amounts not to exceed 200 microcuries total;

(iii) technetium-99m in amounts not to exceed 30 millicuries; and

(iv) any radioactive material, in amounts not to exceed 3 millicuries per source, contained in calibration or reference sources that have been manufactured, labeled, packaged, and distributed in accordance with a specific license issued by the department pursuant to ARM 37.14.542(12) , a specific license issued by the US nuclear regulatory commission, or a specific license issued to the manufacturer by an agreement state or a licensing state pursuant to equivalent regulations.

(e) (i) Any licensee or registrant who possesses sealed sources as calibration or reference sources pursuant to (d) above shall cause each sealed source containing radioactive material, other than hydrogen-3, with a half-life greater than 30 days in any form other than gas to be tested for leakage and/or contamination at intervals not to exceed 6 months. In the absence of a certificate from a transferor indicating that a test has been made within 6 months prior to the transfer, the sealed sources should not be used until tested, provided, however, that no leak tests are required when:

(A) the source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material, or

(B) the sealed source is stored and is not being used; such sources shall, however, be tested for leakage prior to any use or transfer unless they have been leak tested within 6 months prior to the date of use or transfer.

(ii) The leak test shall be capable of detecting the presence of 0.005 microcuries of radioactive material on the test sample. The test sample shall be taken from the sealed source or from the surfaces of the device in which the sealed source is mounted or stored on which contamination might be expected to accumulate. Records of leak test results shall be kept in units of microcuries and maintained for inspection by the department.

(iii) If the leak test reveals the presence of 0.005 microcuries or more of removable contamination, the licensee or registrant shall immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired or to be disposed of in accordance with ARM Title 37, chapter 14, subchapters 5 and 7. A report shall be filed within 5 days of the test with the department describing the equipment involved, the test results, and the corrective action taken.

(f) Any licensee or registrant who possesses and uses calibration and reference sources pursuant to (d) (iv) above shall:

(i) follow the radiation safety and handling instructions approved by the department, the US nuclear regulatory commission, an agreement state or a licensing state and furnished by the manufacturer on the label attached to the source, or permanent container thereof, or in the leaflet or brochure that accompanies the source, and maintain such instruction in a legible and conveniently available form; and

(ii) conduct a quarterly physical inventory to account for all sources received and possessed. Records of the inventories shall be maintained for inspection by the department and shall include the quantities and kinds of radioactive material, location of sources, and the date of the inventory.

(4) In addition to the requirements set forth in ARM 37.14.521, a specific license for human use of sealed sources will be issued only if the applicant or, if the application is made by an institution, the individual user:

(a) has specialized training in the diagnostic or therapeutic use of the sealed source considered, or has experience equivalent to such training, and

(b) is a physician.

(5) In addition to the requirements set forth in ARM 37.14.521, a specific license for use of sealed sources in industrial radiography will be issued if:

(a) the applicant will have an adequate program for training radiographers and radiographer's assistants and submits to the department a schedule or description of such program which specifies the:

(i) initial training,

(ii) periodic training,

(iii) on-the-job training,

(iv) means to be used by the licensee to determine the radiographer's knowledge and understanding of an ability to comply with department rules and licensing requirements, and the operating and emergency procedures of the applicant, and

(v) means to be used by the licensee to determine the radiographer's assistant's knowledge and understanding of and ability to comply with the operating and emergency procedures of the applicant;

(b) the applicant has established and submits to the department satisfactory written operating and emergency procedures;

(c) the applicant will have an adequate internal inspection system, or other management control, to assure that license provisions, rules, and the applicant's operating and emergency procedures are followed by radiographers and radiographer's assistants;

(d) the applicant submits to the department a description of his overall organizational structure pertaining to the industrial radiography program, including specified delegations of authority and responsibility for operation of the program;

(e) the applicant who desires to conduct his own leak tests has established adequate procedures to be followed in leak testing sealed sources for possible leakage and contamination and submits to the department a description of such procedures including:

(i) instrumentation to be used,

(ii) method of performing tests, e.g., points on equipment to be smeared and method of taking smear, and

(iii) pertinent experience of the person who will perform the test; and

(f) the licensee shall conduct a program for inspection and maintenance of radiographic exposure devices and storage containers to assure proper functioning of components important to safety.

(1) This rule prescribes requirements for the issuance of specific licenses of broad scope for radioactive material ("broad licenses") and certain rules governing holders of such licenses. Authority to transfer possession of control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing by-product material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the US Nuclear Regulatory Commission, Washington, DC 20555.

(2) The different types of broad licenses are set forth below:

(a) "Type A specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of the radioactive material specified in the license, but not exceeding quantities specified in the license, for any authorized purposes. The quantities specified are usually in the multi-curie range.

(b) A "Type B specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in Schedule D of this subchapter, for any authorized purposes. The possession limit for a Type B broad license, if only 1 radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Schedule D, Column I. If 2 or more radionuclides are possessed thereunder, the possession limit for each is determined as follows: For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in Schedule D, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

(c) A "Type C specific license of broad scope" is a specific license authorizing receipt, acquisition, ownership, possession, use and transfer of any chemical or physical form of radioactive material specified in Schedule D of this subchapter, for any authorized purpose. The possession limit for a Type C broad license, if only 1 radionuclide is possessed thereunder, is the quantity specified for that radionuclide in Schedule D, Column II. If 2 or more radionuclides are possessed thereunder, the possession limit is determined for each as follows: For each radionuclide determine the ratio of the quantity possessed to the applicable quantity specified in Schedule D, Column II for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity.

(3) An application for a Type A specific license of broad scope will be approved if:

(a) the applicant satisfies the general requirements specified in ARM 37.14.521;

(b) the applicant has engaged in a reasonable number of activities involving the use of radioactive material; and

(c) the applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

(i) the establishment of a radiation safety committee composed of such persons as a radiation safety officer, a representative of management, and persons trained and experienced in the safe use of radioactive material;

(ii) the appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters; and

(iii) the establishment of appropriate administrative procedures to assure:

(A) control of procurement and use of radioactive material;

(B) completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures; and

(C) review, approval, and recording by the radiation safety committee of safety evaluations of proposed uses prepared in accordance with (B) above prior to use of the radioactive material.

(4) An application for a Type B specific license of broad scope will be approved if:

(a) the applicant satisfies the general requirements specified in ARM 37.14.521; and

(b) the applicant has established administrative controls and provisions relating to organization and management, procedures, record keeping, material control and accounting, and management review that are necessary to assure safe operations, including:

(i) the appointment of a radiation safety officer who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiation safety matters, and

(ii) the establishment of appropriate administrative procedures to assure:

(A) control of procurement and use of radioactive material,

(B) completion of safety evaluations of proposed uses of radioactive material which take into consideration such matters as the adequacy of facilities and equipment, training and experience of the user, and the operating or handling procedures, and

(C) review, approval, and recording by the radiation safety officer of safety evaluations of proposed uses prepared in accordance with (B) above prior to use of the radioactive material.

(5) An application for a Type C specific license of broad scope will be approved if:

(a) the applicant satisfies the general requirements specified in ARM 37.14.521;

(b) the applicant submits a statement that radioactive material will be used only by, or under the direct supervision of, individuals who have received:

(i) a college degree at the bachelor level, or equivalent training and experience, in the physical or biological sciences or in engineering, and

(ii) at least 40 hours of training and experience in the safe handling of radioactive material, and in the characteristics of ionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of radioactive material to be used; and

(c) the applicant has established administrative controls and provisions relating to procurement of radioactive material, procedures, record keeping, material control and accounting, and management review necessary to assure safe operations.

(6) Specific licenses of broad scope are subject to the following conditions:

(a) Unless specifically authorized, persons licensed pursuant to this rule shall not:

(i) conduct tracer studies in the environment involving direct release of radioactive material;

(ii) receive, acquire, own, possess, use or transfer devices containing 100,000 curies or more of radioactive material in sealed sources used for irradiation of materials;

(iii) conduct activities for which a specific license issued by the department under ARM 37.14.540 or 37.14.542 is required; or

(iv) add or cause the addition of radioactive material to any food, beverage, cosmetic, drug, or other product designed for ingestion or inhalation by, or application to, a human being.

(b) Each Type A specific license of broad scope issued under this subchapter shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety committee.

(c) Each Type B specific license of broad scope issued under this subchapter shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals approved by the licensee's radiation safety officer.

(d) Each Type C specific license of broad scope issued under this subchapter shall be subject to the condition that radioactive material possessed under the license may only be used by, or under the direct supervision of, individuals who satisfy the requirements of (5) of this rule.

(1) (a) In addition to the requirements set forth in ARM 37.14.521, a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under ARM 37.14.506(1) (b) will be issued if:

(i) the applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer; and

(ii) the applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Schedule A of this subchapter, that reconcentrating of the radioactive material in concentrations exceeding those in Schedule A is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(b) Each person licensed under (1) shall file an annual report with the department which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to (1) during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within 30 days thereafter.

(2) Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing by-product material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirements may be obtained only from the US Nuclear Regulatory Commission, Washington, DC 20555.

(a) An application for a specific license to distribute naturally-occurring and accelerator-produced radioactive materials (NARM) to persons exempted from this subchapter pursuant to ARM 37.14.506(2) will be approved if:

(i) the radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;

(ii) the radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

(iii) the applicant submits copies of prototype labels and brochures and the department approves such labels and brochures.

(b) The license issued under (a) above is subject to the following conditions:

(i) No more than 10 exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of 1 or more of the exempt quantity provided the sum of the fractions shall not exceed unity.

(ii) Each exempt quantity shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to ARM 37.14.506(2) . The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem per hour.

(iii) The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:

(A) identifies the radionuclide and the quantity of radioactivity, and

(B) bears the words "Radioactive Material".

(iv) In addition to the labeling information required by (iii) above, the label affixed to the immediate container, or an accompanying brochure, shall:

(A) state that the contents are exempt from licensing state requirements,

(B) bear the words "Radioactive Material--Not for Human Use--Introduction into Foods, Beverages, Cosmetics, Drugs, or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited--Exempt Quantities should not be Combined", and

(C) set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage, and disposal of the radioactive material.

(c) Each person licensed under (2) shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under ARM 37.14.506(2) or the equivalent regulations of a licensing state, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the department. Each report shall cover the year ending June 20, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to (2) during the reporting period, the report shall so indicate.

(3) An application for a specific license authorizing the incorporation of NARM into gas and aerosol detectors to be distributed to persons exempt under ARM 37.14.506(3) (c) will be approved if the application satisfies requirements equivalent to those contained in 10 CFR Part 32, section 32.26.

(4) (a) An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under ARM 37.14.512(4) or equivalent regulations of the US nuclear regulatory commission, an agreement state or a licensing state will be approved if:

(i) the applicant satisfies the general requirements of ARM 37.14.521;

(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 persons 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 any person will receive in any period of 1 calendar quarter a dose in excess of 10% of the limits specified in the table in ARM 37.14.705(1) , and

(C) under accident conditions (such as fire and explosion) associated with handling, storage, and use of the device, it is unlikely that any person would receive an external addition dose or dose commitment in excess of the following organ doses:

 

Whole body; head and trunk; active  blood-forming organs; gonads; or lens of eye	15 rams
Hands and forearms; feet and ankles;  localized areas of skin averaged over areas no larger than 1 square centimeter	200 rams
Other organs	50 rams

  

(iii) each device bears a durable, legible, clearly visible label or labels approved by the department, 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 any on/off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity, and

(C) the information called for in 1 of the following statements, as appropriate, in the same or substantially similar form:

(I) The receipt, possession, use and transfer of this device, Model                , Serial No.                     , are subject to a general license or the equivalent and the regulations of the US nuclear regulatory commission or a state with which the US 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.

 

                                                                      CAUTION--RADIOACTIVE MATERIAL

                                                                                                                                    

                                                                      (Name of manufacturer or distributor)

(II) The receipt, possession, use, and transfer of this device, Model , 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.

 

                                                                      CAUTION--RADIOACTIVE MATERIAL

                                                                                                                                     

                                                                      (Name of manufacturer or distributor)

 

(D) The model, serial number, and name of the manufacturer or distributor may be omitted from the foregoing label provided the information is elsewhere specified in labeling affixed to the device.

(b) In the event the applicant desires that the device be required to be tested at intervals longer than 6 months, either for proper operation of the on/off mechanism and indicator, if any, or for leakage of radioactive material or for both, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which 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 department will consider information which includes, but is not limited to:

(i) primary containment (source capsule) ;

(ii) protection of primary containment;

(iii) method of sealing containment;

(iv) containment construction material;

(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 license under ARM 37.14.512(4) or under equivalent regulations of the US nuclear regulatory commission, an agreement state or a licensing state be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on/off mechanism and indicator, or remove the device from installation, he shall include in his application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and bases for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a calendar quarter dose in excess of 10% of the limits specified in the table in ARM 37.14.705(2) .

(d) Each person licensed under (4) to distribute devices to generally licensed persons shall:

(i) Furnish a copy of the general license contained in ARM 37.14.512(4) to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license contained in ARM 37.14.512(4) .

(ii) Furnish a copy of the general license contained in the US nuclear regulatory commission's, agreement state's or licensing state's regulation equivalent to ARM 37.14.512(4) or alternatively, furnish a copy of the general license contained in ARM 37.14.512(4) , to each person to whom he directly or through an intermediate person transfers radioactive material in a device for use pursuant to the general license of the US nuclear regulatory commission, the agreement or the licensing state. If a copy of the general license in ARM 37.14.512(4) is furnished to such person, it shall be accompanied by a note explaining that the use of the device is regulated by the US nuclear regulatory commission, agreement state or licensing state under requirements substantially the same as those in ARM 37.14.512(4) .

(iii) Report to the department all transfers of such devices to persons for use under the general license in ARM 37.14.512(4) . Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model number of device transferred, and the quantity and type of radioactive material contained in the device. If 1 or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. If no transfers have been made to persons generally licensed under ARM 37.14.512(4) during the reporting period, the report shall so indicate. The report shall cover each calendar quarter and shall be filed within 30 days thereafter.

(iv) Reports to other agencies include:

(A) Report to the US nuclear regulatory commission all transfers of such devices to persons for use under the US nuclear regulatory commission general license.

(B) Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to ARM 37.14.542(4) for use under a general license in that state's regulations equivalent to ARM 37.14.512(4) .

(C) Such reports shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department and the general licensee, the type and model of the device transferred, and the quantity and type of radioactive material contained in the device. If 1 or more intermediate persons will temporarily possess the device at the intended place of use prior to its possession by the user, the report shall include identification of each intermediate person by name, address, contact, and relationship to the intended user. The report shall be submitted within 30 days after the end of each calendar quarter in which such a device is transferred to the generally licensed person.

(D) If no transfers have been made to US nuclear regulatory commission licensees during the reporting period, this information shall be reported to the US nuclear regulatory commission.

(E) If no transfers have been made to general licensees within a particular state during the reporting period, this information shall be reported to the responsible state agency upon request of the agency.

(5) 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 persons generally licensed under ARM 37.14.512(5) will be approved subject to the following conditions:

(a) The applicant satisfies the general requirements specified in ARM 37.14.521, and

(b) the applicant satisfies the requirements of 10 CFR Part 32, sections 32.53, 32.54, 32.55, 32.56, 32.101, or their equivalent.

(6) An application for a specific license to manufacture calibration and reference sources containing americium-241, plutonium or radium-226 to persons generally licensed under ARM 37.14.512(7) will be approved subject to the following conditions:

(a) The applicant satisfies the general requirement of ARM 37.14.521 and

(b) the applicant satisfies the requirements of 10 CFR Part 32, sections 32.57, 32.58, 32.59, 32.102, and 10 CFR Part 70, section 70.39, or their equivalent.

(7) In addition to requirements set forth in ARM 37.14.521, a specific license authorizing the distribution of radioactive material for use by physicians under the general license in ARM 37.14.512(8) will be issued if:

(a) the applicant submits evidence that the radioactive material is to be manufactured, labeled, and packaged in accordance with a new drug application which the commissioner of food and drugs, food and drug administration, has approved, or in accordance with a license for a biologic product issued by the secretary, department of health, education, and welfare; and

(b) one of the following statements, as appropriate, or a substantially similar statement which contains the information called for in 1 of the following statements, appears on the label affixed to the container or appears in the leaflet or brochure which accompanies the package:

(i) This radioactive drug may be received, possessed, and used only by physicians licensed in the practice of medicine. Its receipt, possession, use and transfer are subject to the regulations and a general license or its equivalent of the US nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority.

                                                                                                                                                                       

                                                                      (Name of manufacturer)

(ii) This radioactive drug may be received, possessed, and used only by physicians licensed in the practice of medicine. Its receipt, possession, use and transfer are subject to the regulations and a general license or its equivalent of a licensing state.

                                                                                                                                                                       

                                                                      (Name of manufacturer)

 

(8) An application for a specific license to manufacture or distribute radioactive material for use under the general license of ARM 37.14.512(9) will be approved if:

(a) The applicant satisfies the general requirements specified in ARM 37.14.521.

(b) The radioactive material is to be prepared for distribution in prepackaged units of:

(i) Iodine-125 in units not exceeding 10 microcuries each.

(ii) Iodine-131 in units not exceeding 10 microcuries each.

(iii) Carbon-14 in units not exceeding 10 microcuries each.

(iv) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each.

(v) Iron-59 in units not exceeding 20 microcuries each.

(vi) Cobalt-57 in units not exceeding 10 microcuries each.

(vii) Selenium-75 in units not exceeding 10 microcuries each.

(viii) Mock iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each.

(c) Each prepackaged unit bears 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 10 microcuries of iodine-125, iodine-131, carbon-14, cobalt-57, or selenium-75; 50 microcuries of hydrogen-3 (tritium) ; 20 microcuries of iron-59; or mock iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each; and

(ii) displaying the radiation caution symbol described in ARM 37.14.725(1) (a) and the words, "CAUTION--RADIOACTIVE MATERIAL", and "Not for Internal or External Use in Humans or Animals".

(d) One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in 1 of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

(i) This radioactive material may be received, acquired, possessed, and used only by physicians, 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 US nuclear regulatory commission or of a state with which the commission has entered into an agreement for the exercise of regulatory authority.

                                                                                                                                                                       

                                                                      (Name of manufacturer)

 

(ii) This radioactive material may be received, acquired, possessed, and used only by physicians, 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)

 

(e) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the mock iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in ARM 37.14.740.

(9) An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under ARM 37.14.512(10) will be approved subject to the following conditions:

(a) the applicant satisfies the general requirements of ARM 37.14.521, and

(b) the criteria of 10 CFR Part 32, sections 32.61, 32.62, 32.103, are met.

(10) An application for a specific license to manufacture and distribute radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to ARM 37.14.540(3) for the uses listed in Group I, Group II, IV, or V of Schedule C of this subchapter will be approved if:

(a) The applicant satisfies the general requirements specified in ARM 37.14.521;

(b) The applicant submits evidence that:

(i) the radiopharmaceutical containing radioactive material will be manufactured, labeled, and packaged in accordance with the federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the food and drug administration (FDA) , a biologic product license issued by FDA or a "Notice of claimed investigational exemption for a new drug" (IND) that has been accepted by the FDA, or

(ii) the manufacture and distribution of the radiopharmaceutical containing radioactive material is not subject to the federal Food, Drug and Cosmetic Act and the Public Health Service Act;

(c) The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material which is appropriate for safe handling and storage of radiopharmaceuticals by group licensees; and

(d) (i) The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, quantity, and date of assay and the label affixed to each package, or the leaflet or brochure which accompanies each package, contains a statement that the radiopharmaceutical is licensed by the department for distribution to persons licensed pursuant to ARM 37.14.540(3) and Schedule C, Group I, Group II, Group IV, and Group V of this subchapter, as appropriate, or under equivalent licenses of the US nuclear regulatory commission, an agreement state or a licensing state.

(ii) The labels, leaflets or brochures required by (d) (i) above are in addition to the labeling required by the food and drug administration (FDA) and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

(11) An application for a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed pursuant to ARM 37.14.540(3) for the uses listed in Group II of Schedule C of this subchapter will be approved if:

(a) The applicant satisfies the general requirements specified in ARM 37.14.521;

(b) the applicant submits evidence that:

(i) the generator or reagent kit is to be manufactured, labeled and packaged in accordance with the federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the food and drug administration (FDA) , a biologic product license issued by FDA, or a "Notice of claimed investigational exemption for a new drug" (IND) that has been accepted by the FDA, or

(ii) the manufacture and distribution of the generator or reagent kit are not subject to the federal Food, Drug and Cosmetic Act and the Public Health Service Act;

(c) the applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or the reagent kit;

(d) the label affixed to the generator or reagent kit contains information on the radionuclide, quantity, and date of assay; and

(e) the label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit, contains:

(i) adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in elating the generator or processing radioactive material with the reagent kit, and

(ii) a statement that this generator or reagent kit (as appropriate) is approved for use by persons licensed by the department pursuant to ARM 37.14.540(3) and Schedule C, Group III of this subchapter or under equivalent licenses of the US nuclear regulatory commission, an agreement state or a licensing state. The labels, leaflets or brochures required by (11) are in addition to the labeling required by FDA and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

NOTE: Although the department does not regulate the manufacture and distribution of reagent kits that do not contain radioactive material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have his reagent kits approved by the department for use by persons licensed pursuant to ARM 37.14.540(3) and Group III of Schedule C of this subchapter may submit the pertinent information specified in (11) .

(12) An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to ARM 37.14.540(3) for use as a calibration or reference source or for the uses listed in Group VI of Schedule C of this subchapter will be approved if:

(a) The applicant satisfies the general requirements in ARM 37.14.521.

(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,

(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; provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label.

(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 name of source or device is licensed by the department for distribution to persons licensed pursuant to ARM 37.14.540(3) and Schedule C, Group VI of this subchapter or under equivalent licenses of the US nuclear regulatory commission, an agreement state or a licensing state, provided, that such labeling for sources which do not require long term storage (e.g., gold-198 seeds) may be on a leaflet or brochure which accompanies the source.

(d) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than 6 months, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.

(e) In determining the acceptable interval for test of leakage of radioactive material, the department will consider information that includes, but is not limited to:

(i) primary containment (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.

(13) 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 ARM 37.14.511(4) or equivalent regulations of the US nuclear regulatory commission or an agreement state will be approved if:

(i) the applicant satisfies the general requirements specified in ARM 37.14.521;

(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 any individual to receive in any period of 1 calendar quarter a radiation dose in excess of 10% of the limits specified in ARM 37.14.705(2) ; 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 department will approve an application for a specific license under (13) 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 department may deny any application for a specific license under (13) if the end use(s) of the industrial product or device cannot be reasonably foreseen.

(d) Each person licensed pursuant to (a) above 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 under which 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 US nuclear regulatory commission or of an agreement state;

(iii) assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium";

(iv) (A) furnish a copy of the general license contained in ARM 37.14.511(4) and a copy of department form MRH-12 to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license contained in ARM 37.14.511(4) , or

(B) furnish a copy of the general license contained in the US nuclear regulatory commission's or agreement state's regulation equivalent to ARM 37.14.511(4) and a copy of the US nuclear regulatory commission's or agreement state's certificate, or alternatively, furnish a copy of the general license contained in ARM 37.14.511(4) and a copy of department form MRH-12 to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license of the US nuclear regulatory commission or an agreement state, with a note explaining that use of the product or device is regulated by the US nuclear regulatory commission or an agreement state under requirements substantially the same as those in ARM 37.14.511(4) ;

(v) report to the department all transfers of industrial products or devices to persons for use under the general license in ARM 37.14.511(4) . Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the department 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 each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under ARM 37.14.511(4) during the reporting period, the report shall so indicate;

(vi) (A) report to the US nuclear regulatory commission all transfers of industrial products or devices to persons for use under the US nuclear regulatory commission general license,

(B) report to the responsible state agency all transfers of devices manufactured and distributed pursuant to (13) for use under a general license in that state's regulations equivalent to ARM 37.14.511(4) ,

(C) such report shall identify each general licensee by name and address, an individual by name and/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 in which such product or device is transferred to the generally licensed person,

(D) if no transfers have been made to US nuclear regulatory commission licensees during the reporting period, this information shall be reported to the US nuclear regulatory commission,

(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; and

(vii) keep records showing the name, address, and point of contact for each general licensee to whom he transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in ARM 37.14.511(4) or equivalent regulations of the US nuclear regulatory commission or of an agreement state. The records shall be maintained for a period of 2 years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of this subchapter.

(1) Any person who, on the effective date of this chapter, possesses a general or specific license for source, byproduct, or special nuclear material in quantities not sufficient to form a critical mass, issued by the US nuclear regulatory commission, shall be deemed to possess a like license issued under this subchapter and the act, such license to expire either 90 days after receipt from the department of a notice of expiration of such license, or on the date of expiration specified in the US nuclear regulatory commission license, whichever is earlier.

(1) Any person who, on the effective date of this chapter, possesses NARM for which a specific license is required by the act or this subchapter shall be deemed to possess such a license issued under the act and this subchapter. Such license shall expire 90 days after the effective date of this chapter; provided, however, that if within the 90 days the person possessing such material files an application in proper form for a license, such existing license shall not expire until the application has been finally determined by the department.

(1) No licensee shall transfer radioactive material except as authorized pursuant to this rule.

(2) Except as otherwise provided in his license and subject to the provisions of (3) and (4) of this rule, any licensee may transfer radioactive material:

(a) to the department. A licensee may transfer material to the department only after receiving prior approval from the department;

(b) to the US department of energy;

(c) to any person exempt from the provisions of this subchapter to the extent permitted under such exemption;

(d) to any person authorized to receive such material under terms of a general license or its equivalent, or a specific license or equivalent licensing document, issued by the department, the US nuclear regulatory commission, any agreement state or any licensing state, or to any person otherwise authorized to receive such material by the federal government or any agency thereof, the department, any agreement state or any licensing state; or

(e) as otherwise authorized by the department in writing.

(3) Before transferring radioactive material to a specific licensee of the department, the US nuclear regulatory commission, an agreement state or a licensing state, or to a general licensee who is required to register with the department, the US nuclear regulatory commission, an agreement state or a licensing state prior to receipt of the radioactive material, the licensee transferring the material shall verify that the transferee's license authorizes the receipt of the type, form, and quantity of radioactive material to be transferred.

(4) The following methods for the verification required by (3) of this rule are acceptable:

(a) The transferor may have in his possession, and read, a current copy of the transferee's specific license or registration certificate;

(b) the transferor may have in his possession a written certification by the transferee that he is authorized by license or registration certificate to receive the type, form and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date;

(c) for emergency shipments the transferor may accept oral certification by the transferee that he is authorized by license or registration certificate to receive the type, form, and quantity of radioactive material to be transferred, specifying the license or registration certificate number, issuing agency, and expiration date; provided, that the oral certification is confirmed in writing within 10 days;

(d) the transferor may obtain other sources of information compiled by a reporting service from official records of the department, the US nuclear regulatory commission, the licensing agency of an agreement state or a licensing state as to the identity of licensees and the scope and expiration dates of licenses and registration; or

(e) when none of the methods of verification described in (a) , (b) , (c) , or (d) above are readily available or when a transferor desires to verify that information received by 1 of such methods is correct or up-to-date, the transferor may obtain and record confirmation from the department, the US nuclear regulatory commission, or the licensing agency of an agreement state or a licensing state that the transferee is licensed to receive the radioactive material.

(5) Preparation for shipment and transport of radioactive material shall be in accordance with the provisions of ARM 37.14.552.

(1) The terms and conditions of all licenses shall be subject to amendment, revision, or modification or the license may be suspended or revoked by reason of amendments to the act, or by reason of rules and orders issued by the department.

(2) Any license may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or any statement of fact required under provisions of the act, or because of conditions revealed by such application or statement of fact or any report, record, or inspection or other means which would warrant the department to refuse to grant a license on an original application, or for violation of, or failure to observe any of the terms and conditions of the act, or of the license, or of any rule or order of the department.

(3) Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no license shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefor, facts or conduct which may warrant such action shall have been called to the attention of the licensee in writing and the licensee shall have been afforded an opportunity to demonstrate or achieve compliance with all lawful requirements.

(4) The department may terminate a specific license upon request submitted by the licensee to the department in writing.

(1) Subject to this chapter, any person who holds a specific license from the US nuclear regulatory commission or any agreement state or licensing state, and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, is hereby granted a general license to conduct the activities authorized in such licensing document within this state for a period not in excess of 180 days in any calendar year provided that:

(a) the licensing document does not limit the activity authorized by such document to specified installations or locations;

(b) the out-of-state licensee notifies the department in writing at least 3 days prior to engaging in such activity. Such notification shall indicate the location, period, and type of proposed possession and use within the state, and shall be accompanied by a copy of the pertinent licensing document. If, for a specific case, the 3-day period would impose an undue hardship on the out-of-state licensee, he may, upon application to the department, obtain permission to proceed sooner. The department may waive the requirement for filing additional written notifications during the remainder of the calendar year following the receipt of the initial notification from a person engaging in activities under the general license provided in (1) .

(c) the out-of-state licensee complies with all applicable rules of the department and with all the terms and conditions of his licensing document, except any such terms and conditions which may be inconsistent with applicable rules of the department;

(d) the out-of-state licensee supplies such other information as the department may request; and

(e) the out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in (1) except by transfer to a person:

(i) specifically licensed by the department or by the US nuclear regulatory commission to receive such material, or

(ii) exempt from the requirements for a license for such material under ARM 37.14.506(1) .

(2) Notwithstanding the provisions of (1) of this rule, any person who holds a specific license issued by the US nuclear regulatory commission or an agreement state authorizing the holder to manufacture, transfer, install, or service a device described in ARM 37.14.512(4) (a) within areas subject to the jurisdiction of the licensing body is hereby granted a general license to install, transfer, demonstrate or service such a device in this state provided that:

(a) such person shall file a report with the department within 30 days after the end of each calendar quarter in which any device is transferred to or installed in this state. Each such report shall identify each general licensee to whom such device is transferred by name and address, the type of device transferred, and the quantity and type of radioactive material contained in the device;

(b) the device has been manufactured, labeled, installed, and serviced in accordance with applicable provisions of the specific license issued to such person by the US nuclear regulatory commission or an agreement state;

(c) such person shall assure that any labels required to be affixed to the device under regulations of the authority which licensed manufacture of the device bear a statement that "Removal of this label is prohibited"; and

(d) the holder of the specific license shall furnish to each general licensee to whom he transfers such device or on whose premises he installs such device a copy of the general license contained in ARM 37.14.512(4) .

(3) The department may withdraw, limit, or qualify its acceptance of any specific license or equivalent licensing document issued by another agency, or any product distributed pursuant to such licensing document, upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.

(1) For the purposes of this rule, a licensee who transports his own licensed material as a private carrier is considered to have delivered such material to a carrier for transport.

(2) No licensee shall deliver any radioactive material to a carrier for transport, unless:

(a) the licensee complies with the applicable requirements of the regulations, appropriate to the mode of transport, of the US department of transportation insofar as such regulations relate to the packaging of radioactive material, and to the monitoring, marking and labeling of those packages;

(b) the licensee has established procedures for opening and closing packages in which radioactive material is transported to provide safety and to assure that, prior to the delivery to a carrier for transport, each package is properly closed for transport; and

(c) prior to delivery of a package to a carrier for transport, the licensee shall assure that any special instructions needed to safely open the package are sent to or have been available to the consignee.

(3) Section (2) of this rule shall not apply to the transportation of licensed material, or to the delivery of licensed material to a carrier for transport, where such transportation is subject to the regulations of the US department of transportation or the US postal service.

SCHEDULE A

 

EXEMPT CONCENTRATIONS

 

Element (atomic number)	Isotope	Column I Gas Concentration µCi/ml1	Column II Liquid & Solid Concentration µCi/ml2
Antimony (51)     Argon (18)	Sb-122 Sb-124 Sb-125 Ar-37 Ar-41	1x10-3 4x10-7	3x10-4 2x10-4 1x10-3
Arsenic (33)	As-73 As-74 As-76 As-77		5x10-3 5x10-4 2x10-4 8x10-4
Barium (56)   Beryllium (4) Bismuth (83)	Ba-131 Ba-140 Be-7 Bi-206		2x10-3 3x10-4 2x10-2 4x10-4
Bromine (35) Cadmium (48)	Br-82 Cd-109 Cd-115m Cd-115	4x10-7	3x10-3 2x10-3 3x10-4 3x10-4
Calcium (20)   Carbon (6) Cerium (58)	Ca-45 Ca-47 C-14 Ce-141 Ce-143 Ce-144	1x10-6	9x10-5 5x10-4 8x10-3 9x10-4 4x10-4 1x10-4
Cesium (55)     Chlorine (17)	Cs-131 Cs-134m Cs-134 Cl-38	9x10-7	2x10-2 6x10-2 9x10-5 4x10-3
Chromium (24) Cobalt (27)     Copper (29) Dysprosium (66)	Cr-51 Co-57 Co-58 Co-60 Cu-64 Dy-165 Dy-166		2x10-2 5x10-3 1x10-3 5x10-4 3x10-3 4x10-3 4x10-4

 

__________

 

¹ Values are given in Column I only for those materials normally used as gases.

² µ C1/gm for solids.

Element (atomic number)	Isotope	Column I Gas Concentration µCi/ml1	Column II Liquid & Solid Concentration µCi/ml2
Erbium (68)   Europium (63)	Er-169 Er-171 Eu-152 Eu-155	6x10-4	9x10-4 1x10-3 (Tr=9.2 h) 2x10-3
Fluorine (9) Gadolinium (64)	F-18 Gd-153 Gd-159	2x10-6	8x10-3 2x10-3 8x10-4
Gallium (31) Germanium (32) Gold (79)	Ga-72 Ge-71   Au-196 Au-198 Au-199		4x10-4 2x10-2   2x10-3 5x10-4 2x10-3
Hafnium (72) Hydrogen (1) Indium (49)	Hf-181 H-3 In-113m In-114m	5x10-6	7x10-4 3x10-2 1x10-2 2x10-4
Iodine (53)	I-126 I-131 I-132 I-133 I-134	3x10-9 3x10-9 8x10-8 1x10-8 2x10-7	2x10-5 2x10-5 6x10-4 7x10-5 1x10-3
Iridium (77)     Iron (26)	Ir-190 Ir-192 Ir-194 Fe-55 Fe-59		2x10-3 4x10-4 3x10-4 8x10-3 6x10-4
Krypton (36)   Lanthanum (57) Lead (82) Lutetium (71)	Kr-85m Kr-85 La-140 Pb-203 Lu-177	1x10-6 3x10-6	2x10-4 4x10-3 1x10-3
Manganese (25)   Mercury (80)     Molybdenum (42)	Mn-52 Mn-54 Mn-56 1x10-3 Hg-197m Hg-197 Hg-203 Mo-99		3x10-4 1x10-3 1x10-3 2x10-3 3x10-3 2x10-4 2x10-3

 

__________

 

¹ Values are given in Column I only for those materials normally used as gases.

² µ C1/gm for solids.

Element (atomic number)	Isotope	Column I Gas Concentration µCi/ml1	Column II Liquid & Solid Concentration µCi/ml2
Neodymium (60)	Nd-147 Nd-149		6x10-4 3x10-3
Nickel (28)	Ni-65		1x10-3
Niobium (Columbium) (41)	Nb-95 Nb-97		1x10-3 9x10-3
Osmium (76)	Os-185 Os-191m Os-191 Os-193		7x10-4 3x10-2 2x10-3 6x10-4
Palladium (46)	Pd-103 Pd-109		3x10-3 9x10-4
Phosphorus (15)	P-32		2x10-4
Platinum (78)	Pt-191 Pt-193m Pt-197m Pt-197		1x10-3 1x10-2 1x10-2 1x10-3
Potassium (19)	K-42		3x10-3
Praseodymium (59)	Pr-142 Pr-143		3x10-4 5x10-4
Promethium (61)	Pm-147 Pm-149		2x10-3 4x10-4
Rhenium (75)	Re-183 Re-186 Re-188		6x10-3 9x10-4 6x10-4
Rhodium (45)	Rh-103m Rh-105		1x10-1 1x10-3
Rubidium (37)	Rb-86		7x10-4
Ruthenium (44)	Ru-97 Ru-103 Ru-105 Ru-106		4x10-3 8x10-4 1x10-3 1x10-4
Samarium (62)	Sm-153		8x10-4
Scandium (21)	Sc-46 Sc-47 Sc-48		4x10-4 9x10-4 3x10-4
Selenium (34)	Se-75		3x10-3
Silicon (14)	Si-31		9x10-3

 

__________

 

¹ Values are given in Column I only for those materials

normally used as gases.

² µ C1/gm for solids.

Element (atomic number)	Isotope	Column I Gas Concentration µCi/ml1	Column II Liquid & Solid Concentration µCi/ml2
Silver (47)	Ag-105 Ag-110m Ag-111		1x10-3 3x10-4 4x10-4
Sodium (11)	Na-24		2x10-3
Strontium (38)	Sr-85 Sr-89 Sr-91 Sr-92		1x10-3 1x10-4 7x10-4 7x10-4
Sulfur (16)	S-35	9x10-8	6x10-4
Tantalum (73)	Ta-182		4x10-4
Technetium (43)	Tc-96m Tc-96		1x10-1 1x10-3
Tellurium (52)	Te-125m Te-127m Te-127 Te-129m Te-131m Te-132		2x10-3 6x10-4 3x10-3 3x10-4 6x10-4 3x10-4
Terbium (65)	Tb-160		4x10-4
Thallium (81)	Tl-200 Tl-201 Tl-202 Tl-204		4x10-3 3x10-3 1x10-3 1x10-3
Thulium (69)	Tm-170 Tm-171		5x10-4 5x10-3
Tin (50)	Sn-113 Sn-125		9x10-4 2x10-4
Tungsten (Wolfram) (74)	W-181 W-187		4x10-3 7x10-4
Vanadium (23)	V-48		3x10-4
Xenon (54)	Xe-131m Xe-133 Xe-135	4x10-6 3x10-6 1x10-6
Ytterbium (70)	Yb-175		1x10-3

 

__________

 

¹ Values are given in Column I only for those materials normally used as gases.

² µ C1/gm for solids.  

 

 

Element  (atomic number)	Isotope	Column I Gas Concentration ì Ci/ml1	Column II Liquid & Solid Concentration ì Ci/ml2
Yttrium (39)	Y-90 Y-91m Y-91 Y-92 Y-93		2x10-4 3x10-2 3x10-4 6x10-4 3x10-4
Zinc (30)	Zn-65 Zn-69m Zn-69		1x10-3 7x10-4 2x102
Zirconium (40)	Zr-95 Zr-97		6x10-4 2x10-4
Beta and/or gamma emitting radioactive material not listed above with half-life less than 3 years		1x10-10	1x10-6

   

NOTE 1: Many radioisotopes disintegrate into isotopes which are also radioactive. In expressing the concentrations in Schedule A the activity stated is that of the parent isotope and takes into account the daughters.

 

NOTE 2: For purposes of ARM 37.14.506 where there is involved a combination of isotopes, the limit for the combination should be derived as follows: determine for each isotope in the product the ratio between the concentration present in the product and the exempt concentration established in Schedule A for the specific isotope when not in combination. The sum of such ratios may not exceed "1" (i.e., unity) .

 

EXAMPLE:          Concentration of Isotope A in Product +

                                    Exempt concentration of Isotope A

                              Concentration of Isotope B in Product # 1

                                    Exempt concentration of Isotope B

__________

¹ Values are given in Column I only for those materials

normally used as gases.

² μC1/gm for solids.

SCHEDULE B

 

EXEMPT QUANTITIES

 

Radioactive Material                                                                                             Microcuries

 

Antimony-122 (Sb 122)                                                                                         100

Antimony-124 (Sb 124)                                                                                           10

Antimony-125 (Sb 125)                                                                                           10

Arsenic-73 (As 73)                                                                                                 100

Arsenic-74 (As 74)                                                                                                   10

Arsenic-76 (As 76)                                                                                                   10

Arsenic-77 (As 77)                                                                                                 100

Barium-131 (Ba 131)                                                                                               10

Barium-133 (Ba 133)                                                                                               10

Barium-140 (Ba 140)                                                                                               10

Bismuth-210 (Bi 210)                                                                                                 1

Bromine-82 (Br 82)                                                                                                  10

Cadmium-109 (Cd 109)                                                                                          10

Cadmium-115m (Cd 115m)                                                                                    10

Cadmium-115 (Cd 115)                                                                                        100

Calcium-45 (Ca 45)                                                                                                 10

Calcium-47 (Ca 47)                                                                                                 10

Carbon-14 (C 14)                                                                                                   100

Cerium-141 (Ce 141)                                                                                             100

Cerium-143 (Ce 143)                                                                                             100

Cerium-144 (Ce 144)                                                                                                  1

Cesium-129 (Cs 129)                                                                                             100

Cesium-131 (Cs 131)                                                                                          1,000

Cesium-134m (Cs 134m)                                                                                       100

Cesium-134 (Cs 134)                                                                                                  1

Cesium-135 (Cs 135)                                                                                                10

Cesium-136 (Cs 136)                                                                                                10

Cesium-137 (Cs 137)                                                                                                10

Chlorine-36 (Cl 36)                                                                                                     10

Chlorine-38 (Cl 38)                                                                                                     10

Chromium-51 (Cr 51)                                                                                            1,000

Cobalt-57 (Co 57)                                                                                                     100

Cobalt-58m (Co 58m)                                                                                                 10

Cobalt-58 (Co 58)                                                                                                       10

Cobalt-60 (Co 60)                                                                                                          1

Copper-64 (Cu 64)                                                                                                    100

Dysprosium-165 (Dy 165)                                                                                           10

Dysprosium-166 (Dy 166)                                                                                         100

Erbium-169 (Er 169)                                                                                                  100

Erbium-171 (Er 171)                                                                                                  100

Europium-152 (Eu 152)9.2h                                                                                      100

Europium-152 (Eu 152)13 yr                                                                                         1

Europium-154 (Eu 154)                                                                                                  1

 

Radioactive Material                                                                                                   Microcuries

 

Europium-155 (Eu 155)                                                                                               10 

Fluorine-18 (F 18)                                                                                                   1,000

Gadolinium-153 (Gd 153)                                                                                            10

Gadolinium-159 (Gd 159)                                                                                          100

Gallium-67 (Ga 67)                                                                                                     100

Gallium-72 (Ga 72)                                                                                                       10

Germanium-71 (Ge 71)                                                                                              100

Gold-198 (Au 198)                                                                                                      100

Gold-199 (Au 199)                                                                                                      100

Hafnium-181 (Hf 181)                                                                                                    10

Holmium-166 (Ho 166)                                                                                               100

Hydrogen-3 (H 3)                                                                                                      1,000

Indium-111 (In 111)                                                                                                      100

Indium-113m (In 113m)                                                                                               100

Indium-114m (In 114m)                                                                                                 10

Indium-115m (In 115m)                                                                                               100

Indium-115 (In 115)                                                                                                        10

Iodine-123 (I 123)                                                                                                         100

Iodine-125 (I 125)                                                                                                             1

Iodine-126 (I 126)                                                                                                             1

Iodine-129 (I 129)                                                                                                             0.1

Iodine-131 (I 131)                                                                                                             1

Iodine-132 (I 132)                                                                                                           10

Iodine-133 (I 133)                                                                                                             1

Iodine-134 (I 134)                                                                                                           10

Iodine-135 (I 135)                                                                                                           10

Iridium-192 (Ir 192)                                                                                                         10

Iridium-194 (Ir 194)                                                                                                       100

Iron-52 (Fe 52)                                                                                                                10

Iron-55 (Fe 55)                                                                                                              100

Iron-59 (Fe 59)                                                                                                                10

Krypton-85 (Kr 85)                                                                                                        100

Krypton-87 (Kr 87)                                                                                                          10

Lanthanum-140 (La 140)                                                                                               10

Lutetium-177 (Lu 177)                                                                                                 100

Manganese-52 (Mn 52)                                                                                                 10

Manganese-54 (Mn 54)                                                                                                 10

Manganese-56 (Mn 56)                                                                                                 10

Mercury-197m (Hg 197m)                                                                                           100

Mercury-197 (Hg 197)                                                                                                  100

Mercury-203 (Hg 203)                                                                                                    10

Molybdenum-99 (Mo 99)                                                                                              100

Neodymium-147 (Nd 147)                                                                                            100

Neodymium-149 (Nd 149)                                                                                            100

Nickel-59 (Ni 59)                                                                                                            100

Nickel-63 (Ni 63)                                                                                                              10

Nickel-65 (Ni 65)                                                                                                            100

Niobium-93m (Nb 93m)                                                                                                   10

Radioactive Material                                                                                                     Microcuries

 

Niobium-95 (Nb 95)                                                                                                         10

Niobium-97 (Nb 97)                                                                                                         10

Osmium-185 (Os 185)                                                                                                    10

Osmium-191m (Os 191m)                                                                                            100

Osmium-191 (Os 191)                                                                                                  100

Osmium-193 (Os 193)                                                                                                  100

Palladium-103 (Pd 103)                                                                                               100

Palladium-109 (Pd 109)                                                                                               100

Phosphorus-32 (P 32)                                                                                                     10

Platinum-191 (Pt 191)                                                                                                   100

Platinum-193m (Pt 193m)                                                                                            100

Platinum-193 (Pt 193)                                                                                                   100

Platinum-197m (Pt 197m)                                                                                            100

Platinum-197 (Pt 197)                                                                                                   100

Polonium-210 (Po 210)                                                                                                     0.1

Potassium-42 (K 42)                                                                                                       10

Potassium-43 (K 43)                                                                                                       10

Praseodymium-142 (Pr 142)                                                                                       100

Praseodymium-143 (Pr 143)                                                                                       100

Promethium-147 (Pm 147)                                                                                             10

Promethium-149 (Pm 149)                                                                                             10

Radium-226 (Ra 226)                                                                                                       0.1

Rhenium-186 (Re 186)                                                                                                 100

Rhenium-188 (Re 188)                                                                                                 100

Rhodium-103m (Rh 103m)                                                                                           100

Rhodium-105 (Rh 105)                                                                                                 100

Rubidium-81 (Rb 81)                                                                                                      10

Rubidium-86 (Rb 86)                                                                                                      10

Rubidium-87 (Rb 87)                                                                                                      10

Ruthenium-97 (Ru 97)                                                                                                   100

Ruthenium-103 (Ru 103)                                                                                                10

Ruthenium-105 (Ru 105)                                                                                                10

Ruthenium-106 (Ru 106)                                                                                                  1

Samarium-151 (Sm 151)                                                                                               10

Samarium-153 (Sm 153)                                                                                             100

Scandium-46 (Sc 46)                                                                                                     10

Scandium-47 (Sc 47)                                                                                                   100

Scandium-48 (Sc 48)                                                                                                     10

Selenium-75 (Se 75)                                                                                                      10

Silicon-31 (Si 31)                                                                                                          100

Silver-105 (Ag 105)                                                                                                        10

Silver-110m (Ag 110m)                                                                                                    1

Silver-111 (Ag 111)                                                                                                      100

Sodium-22 (Na 22)                                                                                                         10

Sodium-24 (Na 24)                                                                                                         10

Strontium-85 (Sr 85)                                                                                                       10

Strontium-89 (Sr 89)                                                                                                         1

 

Radioactive Material                                                                                                     Microcuries

 

Strontium-90 (Sr 90)                                                                                                         0.1

Strontium-91 (Sr 91)                                                                                                       10

Strontium-92 (Sr 92)                                                                                                       10

Sulphur-35 (S 35)                                                                                                          100

Tantalum-182 (Ta 182)                                                                                                    10

Technetium-96 (Tc 96)                                                                                                    10

Technetium-97m (Tc 97m)                                                                                           100

Technetium-97 (Tc 97)                                                                                                  100

Technetium-99m (Tc 99m)                                                                                           100

Technetium-99 (Tc 99)                                                                                                    10

Tellurium-125m (Te 125m)                                                                                             10

Tellurium-127m (Te 127m)                                                                                             10

Tellurium-127 (Te 127)                                                                                                 100

Tellurium-129m (Te 129m)                                                                                             10

Tellurium-129 (Te 129)                                                                                                 100

Tellurium-131m (Te 131m)                                                                                             10

Tellurium-132 (Te 132)                                                                                                   10

Terbium-160 (Tb 160)                                                                                                    10

Thallium-200 (Tl 200)                                                                                                    100

Thallium-201 (Tl 201)                                                                                                    100

Thallium-202 (Tl 202)                                                                                                    100

Thallium-204 (Tl 204)                                                                                                     10

Thulium-170 (Tm 170)                                                                                                    10

Thulium-171 (Tm 171)                                                                                                    10

Tin-113 (Sn 113)                                                                                                             10

Tin-125 (Sn 125)                                                                                                             10

Tungsten-181 (W 181)                                                                                                    10

Tungsten-185 (W 185)                                                                                                    10

Tungsten-187 (W 187)                                                                                                  100

Vanadium-48 (V 48)                                                                                                        10

Xenon-131m (Xe 131m)                                                                                            1,000

Xenon-133 (Xe 133)                                                                                                     100

Xenon-135 (Xe 135)                                                                                                     100

Ytterbium-175 (Yb 175)                                                                                                 100

Yttrium-87 (Y 87)                                                                                                              10

Yttrium-90 (Y 90)                                                                                                              10

Yttrium-91 (Y 91)                                                                                                              10

Yttrium-92 (Y 92)                                                                                                           100

Yttrium-93 (Y 93)                                                                                                           100

Zinc-65 (Zn 65)                                                                                                                10

Zinc-69m (Zn 69m)                                                                                                        100

Zinc-69 (Zn 69)                                                                                                           1,000

Zirconium-93 (Zr 93)                                                                                                       10

Zirconium-95 (Zr 95)                                                                                                       10

Zirconium-97 (Zr 97)                                                                                                       10

 

Any radioactive material not listed above other than alpha emitting radioactive material 0.1

Note 1: For purposes of ARM 37.14.521 where there is involved a combination of isotopes,

the limit for the combination should be derived as follows:

 

Determine the amount of each isotope possessed and 1,000 times the amount in

Schedule B for each of those isotopes when not in combination. The sum of the ratios

of those quantities may not exceed 1 (i.e., unity) .

 

Example:

 

Amt. of Isotope A possessed + Amt. of Isotope B possessed   < 1

1000 x Schedule B quantity        1000 x Schedule B quantity

              for Isotope A                          for Isotope B

 

 

SCHEDULE C

 

GROUPS OF MEDICAL USES OF RADIOACTIVE MATERIAL

 

Group I. Use of prepared radiopharmaceuticals for certain diagnostic studies involving
      measurements of uptake, dilution and excretion (does not include uses involving imaging
      and tumor localizations)

 

(1) Iodine-131 as sodium iodide (Na¹³¹I) for measurement of thyroid uptake.

(2) Iodine-125 as sodium iodide (Na¹²⁵I) for measurement of thyroid uptake.

(3) Iodine-131 as iodinated human serum albumin (IHSA) for determination of blood and blood plasma volume and for studies of cardiovascular function and protein turnover.

(4) Iodine-125 as iodinated human serum albumin (IHSA) for determination of blood and blood plasma volume and for studies of cardiovascular function and protein turnover.

(5) Iodine-131 as labeled rose bengal for liver function studies.

(6) Iodine-125 as labeled rose bengal for liver function studies.

(7) Iodine-131 as labeled fats or fatty acids for fat absorption studies.

(8) Iodine-125 as labeled fats or fatty acids for fat absorption studies.

(9) Iodine-131 as labeled iodopyracet, sodium iodohippurate, sodium diatrizoate, diatrizoate methylglucamine, sodium diprotrizoate, sodium acetrizoete, or sodium iothalamate for kidney function studies.

(10) Iodine-125 as labeled iodopyracet, sodium iodohippurate, sodium diatrizoate, distrizoate methylglucamine, sodium diprotrizoate, sodium acetrizoate, or sodium iothalamate for kidney function studies.

(11) Cobalt-57 as labeled cyanocobalamin for intestinal absorption studies.

(12) Cobalt-58 as labeled cyanocobalamin for intestinal absorption studies.

(13) Cobalt-60 as labeled cyanocobalamin for intestinal absorption studies.

(14) Chromium-51 as sodium chromate for determination of red blood cell volume and studies of red blood cell survival time and gastrointestinal blood loss.

(15) Chromium-51 as labeled human serum albumin for gastrointestinal protein loss studies.

(16) Iron-59 as chloride, citrate, or sulfate for iron turnover studies.

(17) Potassium-42 as chloride for potassium space determinations.

(18) Sodium-24 as chloride for sodium space determinations.

(19) Technetium-99m as pertechnetate for blood flow studies.

(20) Mercury as chlormerodrin for kidney function studies.

(21) Any radioactive material in a radiopharmaceutical and for a diagnostic use involving measurements of uptake, dilution, or excretion for which a "Notice of Claimed Investigational Exemption for a New Drug" (IND) has been accepted by the Food and Drug Administration (FDA) .

(22) Iodine-123 as sodium iodide (NaI) for measurement of thyroid uptake.

 

Group II. Use of prepared radiopharmaceuticals for diagnostic studies involving imaging
      and tumor localizations

 

(1) Iodine-131 as sodium iodide for thyroid imaging.

(2) Iodine-125 as sodium iodide for thyroid imaging.

(3) Iodine-131 as iodinated human serum albumin (IHSA) for brain tumor localizations and cardiac imaging.

(4) Iodine-131 as macroaggregated iodinated human serum albumin for lung imaging.

(5) Iodine-131 as colloidal (microaggregated) iodinated human serum albumin for liver imaging.

(6) Iodine-131 as labeled rose bengal for liver imaging.

(7) Iodine-131 as iodopyracet, sodium iodohippurate, sodium diatrizoate, diatrizoate methyglucamine, sodium diprotrizoate, or sodium acetrizoate for kidney imaging.

(8) Iodine-131 as sodium iodipamide for cardiac imaging.

(9) Iodine-131 as iodinated human serum albumin (IHSA) for placenta localization.

(10) Chromium-51 as sodium chromate for spleen imaging.

(11) Chromium-51 as labeled human serum albumin for placenta localization.

(12) Gold-198 in colloidal form for liver imaging.

(13) Mercury-197 as labeled chlormerodrin for kidney and brain imaging.

(14) Mercury-203 as labeled chlormerodrin for brain imaging.

(15) Selenium-75 as labeled selenomethionine for pancreas imaging.

(16) Strontium-85 as nitrate or chloride for bone imaging in patients with suspected or diagnosed cancer.

(17) Technetium-99m as pertechnetate for brain imaging.

(18) Technetium-99m as pertechnetate for thyroid imaging.

(19) Technetium-99m as pertechnetate for salivary gland imaging.

(20) Technetium-99m as pertechnetate for blood pool imaging, including placenta localization.

(21) Technetium-99m as labeled sulfur colloid for liver, spleen, and bone marrow imaging.

(22) Technetium-99m as labeled macroaggregated human serum albumin for lung imaging.

(23) Any radioactive material in a radiopharmaceutical prepared from a reagent kit listed in (4) of Group III.

(24) Any radioactive material in a radiopharmaceutical and for a diagnostic use involving imaging for which a "Notice of Claimed Investigational Exemption for a New Drug" (IND) has been accepted by the Food and Drug Administration (FDA) .

(25) Fluorine-18 in solution for bone imaging.

(26) Strontium-87m for bone imaging.

(27) Iodine-125 as fibrinogen for detection and monitoring of developing deep vein thrombosis.

(28) Ytterbium-169 as labeled diethylenetriamine-pentaacetic acid (DTPA) for cistornography.

(29) Iodine-123 as sodium iodide (NaI) for thyroid imaging.

(30) Indium-113m as chloride for blood pool imaging, including placenta localization.

 

Group III. Use of generators and reagent kits for the preparation and use of radiopharmaceuticals 
      containing radioactive material for certain diagnostic uses

 

(1) Molybdenum-99/technetium-99m generators for the elution of technetium-99m as pertechnetate for:

(i) brain imaging;

(ii) thyroid imaging;

(iii) salivary gland imaging;

(iv) blood pool imaging including placenta localization;

(v) blood flow studies; and

(vi) use with reagent kits for preparation and use of radiopharmaceuticals containing technetium-99m as provided in (4) and (5) of this group.

(2) Yttrium-87/strontium-87m generators for the elution of strontium-87m for bone imaging.

(3) Technetium-99m as pertechnetate for use with reagent kits for preparation and use of radiopharmaceuticals containing technetium-99m as provided in (4) and (5) of this group.

(4) Reagent kits for preparation of technetium-99m labeled:

(i) sulfur colloid for liver, spleen, and bone marrow imaging;

(ii) iron-ascorbate-diethylenetriaminepentaacetic acid complex for kidney imaging;

(iii) diethylenetriaminepentaacetic acid (Sn) for kidney imaging and kidney function studies;

(iv) diethylenetriaminepentaacetic acid (Sn) for brain imaging;

(v) human serum albumin microspheres for lung imaging;

(vi) polyphosphates for bone imaging;

(vii) macroaggregated human serum albumin for lung imaging;

(viii) distannous etidronate complex for bone imaging;

(ix) stannous pyrophosphate for bone and cardiac imaging;

(x) human serum albumin for heart blood pool imaging; and

(xi) medronate sodium for bone imaging.

(5) Any generator or reagent kit for preparation and diagnostic use of a radiopharmaceutical containing radioactive material for which generator or reagent kit a "Notice of Claimed Investigational Exemption for a New Drug" (IND) has been accepted by the Food and Drug Administration (FDA) .

(6) Tin-113/indium-113m generators for the elution of indium-113m as chloride for:

(i) blood pool imaging including placenta localization.

 

Group IV. Use of prepared radiopharmaceuticals for certain therapeutic uses that do not
      normally require hospitalization for purposes of radiation safety

 

(1) Iodine-131 as iodide for treatment of hyperthyroidism and cardiac dysfunction.

(2) Phosphorus-32 as soluble phosphate for treatment of polycythemia vera, leukemia, and bone metastases.

(3) Phosphorus-32 as colloidal chromic phosphate for intracavitary treatment of malignant effusions.

(4) Any radioactive material in a radiopharmaceutical and for a therapeutic use not normally requiring hospitalization for purposes of radiation safety for which a "Notice of Claimed Investigational Exemption for a New Drug" (IND) has been accepted by the Food and Drug Administration (FDA) .

 

Group V. Use of prepared radiopharmaceuticals for certain therapeutic uses that normally
      require hospitalization for purposes of radiation safety

 

(1) Gold-198 as colloid for intracavitary treatment of malignant effusions.

(2) Iodine-131 as iodide for treatment of thyroid carcinoma.

(3) Any radioactive material in a radiopharmaceutical and for a therapeutic use normally requiring hospitalization for radiation safety reasons for which a "Notice of Claimed Investigational Exemption for a New Drug" (IND) has been accepted by the Food and Drug Administration (FDA) .

 

Group VI. Use of sources and devices containing radioactive material for certain medical uses

 

(1) Americium-241 as a sealed source in a device for bone mineral analysis.

(2) Cesium-137 encased in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer.

(3) Cobalt-60 encased in needles and applicator cells for topical, interstitial, and intracavitary treatment of cancer.

(4) Gold-198 as seeds for interstitial treatment of cancer.

(5) Iodine-125 as a sealed source in a device for bone mineral analysis.

(6) Iridium-192 as seeds encased in nylon ribbon for interstitial treatment of cancer.

(7) Strontium-90 sealed in an applicator for treatment of superficial eye conditions.

(8) Radon-222 as seeds for topical, interstitial, and intracavitary treatment of cancer.

(9) Radium-226 as a sealed source for topical, interstitial, and intracavitary treatment of cancer.

(10) Iodine-125 as seeds for interstitial treatment of cancer.

SCHEDULE D

 

LIMITS FOR BROAD LICENCES

 

Radioactive Material	Col. I curies	Col. II curies
Antimony-122	1	0.01
Antimony-124	1	0.01
Antimony-125	1	0.01
Arsenic-73	10	0.1
Arsenic-74	1	0.01
Arsenic-76	1	0.01
Arsenic-77	10	0.1
Barium-131	10	0.1
Barium-140	1	0.01
Beryllium-7	10	0.1
Bismuth-210	0.1	0.001
Bromine-82	10	0.1
Cadmium-109	1	0.01
Cadmium-115m	1	0.01
Cadmium-115	10	0.1
Calcium-45	1	0.01
Calcium-47	10	0.1
Carbon-14	100	1.
Cerium-141	10	0.1
Cerium-143	10	0.1
Cerium-144	0.1	0.001
Cesium-131	100	1.
Cesium-134m	100	1.
Cesium-134	0.1	0.001
Cesium-135	1	0.01
Cesium-136	10	0.1
Cesium-137	0.1	0.001
Chlorine-36	1	0.01
Chlorine-38	100	1.
Chromium-51	100	1.
Cobalt-57	10	0.1
Cobalt-58m	100	1.
Cobalt-58	1	0.01
Cobalt-60	0.1	0.001
Copper-64	10	0.1
Dysprosium-165	100	1.
Dysprosium-166	10	0.1
Erbium-169	10	0.1
Erbium-171	10	0.1
Europium-152 (9.2h)	10	0.1
Europium-152 (13 y)	0.1	0.001
Europium-154	0.1	0.001
Europium-155	1	0.01
Fluorine-18	100	1.

   

  

  

Radioactive Material	Col. I curies	Col. II curies
Gadolinium-153	1	0.01
Gadolinium-159	10	0.1
Gallium-72	10	0.1
Germanium-71	100	1.
Gold-198	10	0.1
Gold-199	10	0.1
Hafnium-181	1	0.01
Holmium-166	10	0.1
Hydrogen-3	100	1.
Indium-113m	100	1.
Indium-114m	1	0.01
Indium-115m	100	1.
Indium-115	1	0.01
Iodine-125	0.1	0.001
Iodine-126	0.1	0.001
Iodine-129	0.1	0.001
Iodine-131	0.1	0.001
Iodine-132	10	0.1
Iodine-133	1	0.01
Iodine-134	10	0.1
Iodine-135	1	0.01
Iridium-192	1	0.01
Iridium-194	10	0.1
Iron-55	10	0.1
Iron-59	1	0.01
Krypton-85	100	1.
Krypton-87	10	0.1
Lanthanum-140	1	0.01
Lutetium-177	10	0.1
Manganese-52	1	0.01
Manganese-54	1	0.01
Manganese-56	10	0.1
Mercury-197m	10	0.1
Mercury-197	10	0.1
Mercury-203	1	0.01
Molybdenum-99	10	0.1
Neodymium-147	10	0.1
Neodymium-149	10	0.1
Nickel-59	10	0.1
Nickel-63	1	0.01
Nickel-65	10	0.1
Niobium-93m	1	0.01
Niobium-95	1	0.01
Niobium-97	100	1.
Osmium-185	1	0.01
Osmium-191m	100	1.
Osmium-191	10	0.1

      

  

Radioactive Material	Col. I  curies	Col. II curies
Osmium-193	10	0.1
Palladium-103	10	0.1
Palladium-109	10	0.1
Phosphorus-32	1	0.01
Platinum-191	10	0.1
Platinum-193m	100	1.
Platinum-193	10	0.1
Platinum-197m	100	1.
Platinum-197	10	0.1
Polonium-210	0.1	0.0001
Potassium-42	1	0.01
Praseodymium-142	10	0.1
Praseodymium-143	10	0.1
Promethium-147	1	0.01
Promethium-149	10	0.1
Radium-226	0.01	0.0001
Rhenium-186	10	0.1
Rhenium-188	10	0.1
Rhodium-103m	1,000	10.
Rhodium-105	10	0.1
Rubidium-86	1	0.01
Rubidium-87	1	0.01
Ruthenium-97	100	1.
Ruthenium-103	1	0.01
Ruthenium-105	10	0.1
Ruthenium-106	0.1	0.001
Samarium-151	1	0.01
Samarium-153	10	0.1
Scandium-46	1	0.01
Scandium-47	10	0.1
Scandium-48	1	0.01
Selenium-75	1	0.01
Silicon-31	10	0.1
Silver-105	1	0.01
Silver-110m	0.1	0.001
Silver-111	10	0.1
Sodium-22	0.1	0.001
Sodium-24	1	0.01
Strontium-85m	1,000	10.
Strontium-85	1	0.01
Strontium-89	1	0.01
Strontium-90	0.01	0.0001
Strontium-91	10	0.1
Strontium-92	10	0.1
Sulphur-35	10	0.1
Tantalum-182	1	0.01
Technetium-96	10	0.1
Technetium-97m	10	0.1

          

  

Radioactive Material	Col. I curies	Col. II curies
Technetium-97	10	0.1
Technetium-99m	100	1.
Technetium-99	1	0.01
Tellurium-125m	1	0.01
Tellurium-127m	1	0.01
Tellurium-127	10	0.1
Tellurium-129m	1	0.01
Tellurium-129	100	1.
Tellurium-131m	10	0.1
Tellurium-132	1	0.01
Terbium-160	1	0.01
Thallium-200	10	0.1
Thallium-201	10	0.1
Thallium-202	10	0.1
Thallium-204	1	0.01
Thulium-170	1	0.01
Thulium-171	1	0.01
Tin-113	1	0.01
Tin-125	1	0.01
Tungsten-181	1	0.01
Tungsten-185	1	0.01
Tungsten-187	10	0.1
Vanadium-48	1	0.01
Xenon-131m	1,000	10.
Xenon-133	100	1.
Xenon-135	100	1.
Ytterbium-175	10	0.1
Yttrium-90	1	0.01
Yttrium-91	1	0.01
Yttrium-92	10	0.1
Yttrium-93	1	0.01
Zinc-65	1	0.01
Zinc-69m	10	0.1
Zinc-69	100	1.
Zirconium-93	1	0.01
Zirconium-95	1	0.01
Zirconium-97	1	0.01

              

Any radioactive material other than source material, special nuclear material, or alpha emitting radioactive material not listed above. 0.1 0.001

(1) This subchapter establishes standards for protection against radiation hazards. Except as otherwise specifically provided, this subchapter applies to all licensees or registrants. Nothing in this subchapter shall be interpreted as limiting the intentional exposure of patients to radiation for the purpose of medical diagnosis or therapy.

(2) In addition to complying with the requirements set forth in this subchapter, every reasonable effort should be made to maintain radiation exposures, and releases of radioactive material in effluents to unrestricted areas, as low as is reasonably achievable. The term "as low as is reasonably achievable" means as low as is reasonably achievable taking into account the state of technology, and the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to the utilization of ionizing radiation in the public interest.

(1) For determining the doses specified in this rule, a dose from X or gamma rays up to 10 MeV may be assumed to be equivalent to the exposure measured by a properly calibrated appropriate instrument in air at or near the body surface in the region of the highest dose rate.

(2) Except as provided in (3) of this rule, no licensee or registrant shall possess, use, receive, or transfer sources of radiation in such a manner as to cause any individual in a restricted area to receive in any period of 1 calendar quarter from all sources of radiation in the licensee's or registrant's possession a dose in excess of the limits specified in the following table:

 

Rems per calendar quarter

Whole body; head and trunk;

active blood-forming organs;

lens of eyes; or gonads . . . . . . . . . . ........................................................1 1/4

Hands and forearms; feet

and ankles . . . . . . . . . . . . . . . . ...............................................................18 3/4

Skin of whole body . . . . . . . . . . . . . ..........................................................7 1/2

 

(3) A licensee or registrant may permit an individual in a restricted area to receive a dose to the whole body greater than that permitted under (2) of this rule, provided:

(a) during any calendar quarter the dose to the whole body from sources of radiation in the licensee's or registrant's possession shall not exceed 3 rems;

(b) the dose to the whole body, when added to the accumulated occupational dose to the whole body, shall not exceed 5(N-18) rems where "N" equals the individual's age in years at his last birthday; and

(c) the licensee or registrant has determined the individual's accumulated occupational dose to the whole body on department form MRH-30 or on a clear and legible record containing all the information required in that form and has otherwise complied with the requirements of ARM 37.14.706. As used in (3) , "dose to the whole body" shall be deemed to include any dose to the whole body, gonads, active blood-forming organs, head and trunk, or lens of eye.

(1) This rule contains requirements which must be satisfied by licensees or registrants who propose, pursuant to ARM 37.14.705(3) to permit individuals in a restricted area to receive exposure to radiation in excess of the limits specified in ARM 37.14.705(2) .

(2) Before permitting any individual in a restricted area to be exposed to radiation in excess of the limits specified in ARM 37.14.705(2) , each licensee or registrant shall:

(a) obtain a certificate on department form MRH-30 or on a clear and legible record containing all the information required in that form, signed by the individual, showing each period of time after the individual attained the age of 18 in which the individual received an occupational dose of radiation; and

(b) calculate on department form MRH-30, in accordance with the instructions appearing therein, or on a clear and legible record containing all the information required in that form, the previously accumulated occupational dose received by the individual and the additional dose allowed for that individual under ARM 37.14.705(3) .

(c) In the preparation of department form MRH-30, or a clear and legible record containing all the information required in that form, the licensee or registrant shall make a reasonable effort to obtain reports of the individual's previously accumulated occupational dose. For each period for which the licensee or registrant obtains such reports, he shall use the dose shown in the report in preparing the form. In any case where a licensee or registrant is unable to obtain reports of the individual's occupational dose for a previous complete calendar quarter, it shall be assumed that the individual has received the occupational dose specified in whichever of the following columns apply:

 

	Column 1	Column 2
	Assumed Dose in Rems for Calendar Quarters Prior to	Assumed dose in Rems for Calendar Quarters Beginning on or after
Part of Body	January 1, 1961	January 1, 1961
Whole body, gonads, active blood-forming organs, head and trunk, lens of eye	3 3/4	1 1/4

(d) The licensee or registrant shall retain and preserve records used in preparing department form MRH-30 until the department authorizes their disposition. If calculation of the individual's accumulated occupational dose for all periods prior to January 1, 1961, yields a result higher than the applicable accumulated dose value for the individual as of that date, as specified in ARM 37.14.705(3) (b) , the excess may be disregarded.