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(1) Shall assure that all labels affixed to the device at the time of reeipt and bearing a statement that renoval of the label is prohibited are naintained thereon and shall comply with all instructions and precautions provided by such labels;

(2) Shall assure that the device is ested for leakage of radioactive mate‘ial and proper operation of the on-off nechanism and indicator, if any, at no onger than six-month intervals or at such other intervals as are specified in he label; however:

(i) Devices containing only krypton need not be tested for leakage of ralioactive material, and

(ii) Devices containing only tritium or not more than 100 microcuries of other beta and/or gamma emitting naterial or 10 microcuries of alpha mitting material and devices held in torage in the original shipping conainer prior to initial installation need tot be tested for any purpose;

(3) Shall assure that the tests reuired by paragraph (c)(2) of this secion and other testing, installation, ervicing, and removal from installaon involving the radioactive materiIs, its shielding or containment, are erformed: (i) In accordance with the instrucons provided by the labels; or (ii) By a person holding a specific linse pursuant to Parts 30 and 32 of lis chapter or from an Agreement ate to perform such activities; (4) Shall maintain records showing mpliance with the requirements of ragraphs (c)(2) and (c)(3) of this ction. The records shall show the reIts of tests. The records also shall ow the dates of performance of, and e names of persons performing, test}, installation, servicing, and removfrom installation concerning the raactive material, its shielding or connment. Records of tests for leakage

radioactive material required by ragraph (c)(2) of this section shall maintained for one year after the it required leak test is performed or il the sealed source is transferred disposed of. Records of tests of the off mechanism and indicator, rered by paragraph (c)(2) of this sec1, shall be maintained for one year or 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 paragraph (c)(3) of this section shall be maintained for a period of two years from the date of the recorded event or until the device is transferred or disposed of;

(5) Upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding of the radioactive material or the on-off mechanism or indicator, or upon the detection of 0.005 microcurie or more removable radioactive material, shall immediately suspend operation of the device until it has been repaired by the manufacturer or other person holding a specific license pursuant to Parts 30 and 32 of this chapter or from an Agreement State to repair such devices, or disposed of by transfer to a person authorized by a specific license to receive the byproduct material contained in the device and, within 30 days, furnish to the Director of the appropriate Nuclear Regulatory Commission, Inspection and Enforcement Regional Office listed in Appendix D of Part 20 of this chapter, a report containing a brief description of the event and the remedial action taken;

(6) Shall not abandon the device containing byproduct material;

(7) Shall not export the device containing byproduct material except in accordance with Part 110 of this chapter;

(8) Except as provided in paragraph (c)(9) of this section, shall transfer or dispose of the device containing by. product material only by transfer to persons holding a specific license pursuant to Parts 30 and 32 of this chapter or from an Agreement State to receive the device and within 30 days after transfer of a device to a specific licensee shall furnish to the Director of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555 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 li

censee in order to obtain a replace- (a) [Reserved) ment device;

(b) The device has been manufac(9) Shall transfer the device to an- tured, labeled, installed, and serviced other general licensee only:

in accordance with applicable provi(i) Where the device remains in use sions of the specific license issued to at a particular location. In such case such person by the Agreement State. the transferor shall give the transfer (c) Such person assures that any ee a copy of this section and any labels required to be affixed to the safety documents identified in the device under regulations of the Agreelabel of the device and within 30 days ment State which licensed manufacof the transfer, report to the Director ture of the device bear a statement of Nuclear Material Safety and Safe- that removal of the label is prohibited. guards, U.S. Nuclear Regulatory Com

(Secs. 81, 181b., 274, Pub. L. 83-703, as amendmission, Washington, D.C. 20555, the

ed, 68 Stat. 935, 948, 73 Stat. 688 (42 U.S.C. manufacturer's name and model 2111, 22016., 2021)] number of device transferred, the name and address of the transferee,

(30 FR 8189, June 26, 1965, as amended at and the name and/or position of an in

30 FR 10947, Aug. 24, 1965; 39 FR 43533,

Dec. 16, 1974; 46 FR 44151, Sept. 3, 1981) dividual who may constitute a point of contact between the Commission and

8 31.7 Luminous safety devices for use in the transferee; or

aircraft. (ii) Where the device is held in storage in the original shipping container

(a) A general license is hereby issued at its intended location of use prior to

to own, receive, acquire, possess, and initial use by a general licensee.

use tritium or promethium-147 con(10) Shall comply with the provi

tained in luminous safety devices for sions of $ $ 20.402 and 20.403 of this

use in aircraft, provided each device chapter for reporting radiation inci

contains not more than 10 curies of dents, theft or loss of licensed materi

tritium or 300 millicuries of promethal, but shall be exempt from the other

ium-147 and that each device has been requirements of Parts 19, 20, and 21,

manufactured, assembled or initially of this chapter.

transferred in accordance with a li(d) The general license in paragraph

cense issued under the provisions of (a) of this section does not authorize

§ 32.53 of this chapter or manufacthe manufacture or import of devices

tured or assembled in accordance with containing byproduct material.

a specific license issued by an Agree

ment State which authorizes manufac(Secs. 201 and 202, Pub. L. 93-438, 88 Stat.

ture or assembly of the device for dis1242, 1244 (42 U.S.C. 5841, 5842) sec. 161, as tribution to persons generally licensed amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201))

by the Agreement State. [39 FR 43532, Dec. 16, 1974, as amended at

(b) Persons who own, receive, ac40 FR 8785, Mar. 3, 1975; 40 FR 14085, Mar.

quire, possess or use luminous safety 28, 1975; 41 FR 18302, May 3, 1976; 42 FR

devices pursuant to the general license 25721, May 19, 1977; 42 FR 28896, June 6,

in this section are exempt from the re1977; 43 FR 6922, Feb. 17, 1978]

quirements of Parts 19, 20, and 21, of

this chapter, except that they shall 8 31.6 General license to install devices comply with the provisions of generally licensed in 8 31.5.

$ $ 20.402 and 20.403 of this chapter. Any person who holds a specific li (c) This general license does not aucense issued by an Agreement State

thorize the manufacture, assembly, authorizing the holder to manufac

repair or import of luminous safety deture, install, or service a device de

vices containing tritium or promethscribed in § 31.5 within such Agree ium-147. ment State is hereby granted a general (d) This general license does not aulicense to install and service such thorize the export of luminous safety device in any non-Agreement State devices containing tritium or promethand a general license to install and ium-147. service such device in offshore waters, (e) This general license does not auas defined in $ 150.3(f) of this chapter: thorize the ownership, receipt, acquisiProvided, That:

tion, possession or use of promethium- (1) Shall not possess at any one 147 contained in instrument dials.

time, at any one location of storage or

use, more than 5 microcuries of ameri(Sec. 202, Pub. L. 93-438, 88 Stat. 1244 (42

cium-241 in such sources: U.S.C. 5842) sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); sec.

(2) Shall not receive, possess, use or 201, as amended, Pub. L. 93-438, 88 Stat.

transfer such source unless the source, 1243 (42 U.S.C. 5841))

or the storage container, bears a label (30 FR 8189, June 26, 1965, as amended at which includes the following state33 FR 6463, Apr. 27, 1968; 38 FR 22220, Aug. ment or a substantially similar state17, 1973; 42 FR 28896, June 6, 1977; 43 FR ment which contains the information 6922, Feb. 17, 1978)

called for in the following statement:' $ 31.8 Americium-241 in the form of cali. The receipt, possession, use and transfer bration or reference sources.

of this source, Model -, Serial No.

are subject to a general license and the reg(a) A general license is hereby issued

ulations of the United States Nuclear Reguto those persons listed below to own,

latory Commission or of a State with which receive, acquire, possess, use and trans- the Commission has entered into an agreefer, in accordance with the provisions ment for the exercise of regulatory authoriof paragraphs (b) and (c) of this sec- ty. Do not remove this label. tion, americium-241 in the form of calibration or reference sources:

CAUTION – RADIOACTIVE MATERIAL

-THIS SOURCE CONTAINS AMERI(1) Any person in a non-Agreement

CIUM-241. DO NOT TOUCH RADIOACState who holds a specific license

TIVE PORTION OF THIS SOURCE. issued pursuant to this chapter which authorizes him to receive, possess, use

-(Name of manufacturer

or initial transferor) and transfer byproduct material, source material, or special nuclear ma- (3) Shall not transfer, abandon, or terial; and

dispose of such source except by trans(2) Any Government agency, as de- fer to a person authorized by a license fined in § 30.4(g) of this chapter, pursuant to this chapter or from an which holds a specific license issued Agreement State to receive the source. pursuant to this chapter which au- (4) Shall store such source, except thorizes it to receive, possess, use and when the source is being used, in a transfer byproduct material, source closed container adequately designed material, or special nuclear material. and constructed to contain americium

(b) The general license in paragraph 241 which might otherwise escape (a) of this section applies only to cali- during storage. bration or reference sources which (5) Shall not use such source for any have been manufactured or initially purpose other than the calibration of transferred in accordance with the radiation detectors or the standardizaspecifications contained in a specific li- tion of other sources. cense issued pursuant to $ 32.57 of this (d) This general license does not auchapter or in accordance with the thorize the manufacture or import of specifications contained in a specific li- calibration or reference sources concense issued to the manufacturer by taining americium-241. an Agreement State which authorizes (e) This general license does not aumanufacture of the sources for distri- thorize the export of calibration or bution to persons generally licensed by

reference sources containing amerithe Agreement State.

cium-241. (c) The general license in paragraph (a) of this section is subject to the pro

(Sec. 202, Pub. L. 93-438, 88 Stat. 1244 (42 visions of $$ 30.14(d), 30.34 (a) to (e),

U.S.C. 5842) sec. 161, as amended, Pub. L.

83-703, 68 Stat. 948 (42 U.S.C. 2201); sec. and 30.51 to 30.63 of this chapter, and

201, as amended, Pub. L. 93-438, 88 Stat. to the provisions of Parts 19, 20, and

1243 (42 U.S.C. 5841)) 21, of this chapter. In addition, persons who own, receive, acquire, pos

Sources generally licensed under this secsess, use and transfer one or more cali

tion prior to January 19, 1975 may bear bration or reference sources pursuant labels authorized by the regulations in to this general license:

effect on January 1, 1975.

(30 FR 8189, June 26, 1965, as amended at 38 FR 22220, Aug. 17, 1973; 40 FR 8785, Mar. 3, 1975; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 1978)

$ 31.9 General license to own byproduct

material. A general license is hereby issued to own byproduct material without regard to quantity. Notwithstanding any other provision of this chapter, a general licensee under this paragraph is not authorized to manufacture, produce, transfer, receive, possess, use, import or export byproduct material, except as authorized in a specific license.

(3) Are exempt from the requirements of Parts 19, 20, and 21, of this chapter except that such persons shall comply with the provisions

of $ $ 20.301, 20.402, and 20.403 of this chapter.

(c) The general license does not authorize the manufacture, assembly, disassembly, repair, or import of strontium 90 in ice detection devices. (Sec. 202, Pub. L. 93-438, 88 Stat. 1244 (42 U.S.C. 5842) sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); sec. 201, as amended, Pub. L. 93-438, 88 Stat. 1243 (42 U.S.C. 5841)) (30 FR 9905, Aug. 10, 1965, as amended at 38 FR 22220, Aug. 17, 1973; 40 FR 8785, Mar. 3, 1975; 42 FR 28896, June 6, 1977; 43 FR 6922, Feb. 17, 1978)

8 31.10 General license for strontium 90 in

ice detection devices. (a) A general license is hereby issued to own, receive, acquire, possess, use, and transfer strontium 90 contained in ice detection devices, provided each device contains not more than fifty microcuries of strontium 90 and each device has been manufactured or initially transferred in accordance with the specifications contained in a license issued pursuant to $ 32.61 of this chapter or in accordance with the specifications contained in a specific license issued to the manufacturer by an Agreement State which authorizes manufacture of the ice detection devices for distribution to persons generally licensed by the Agreement State.

(b) Persons who own, receive, acquire, possess, use, or transfer strontium 90 contained in ice detection devices pursuant to the general license in paragraph (a) of this section:

(1) Shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license pursuant to Part 30 or 32 of this chapter or from an Agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of $ 20.301 of this chapter;

(2) Shall assure that all labels af. fixed to the device at the time of receipt, and which bear a statement which prohibits removal of the labels, are maintained thereon;

8 31.11 General license for use of byprod

uct material for certain in vitro clinical

or laboratory testing. (a) A general license is hereby issued to any physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital to receive, acquire, possess, transfer, or use, for any of the following stated tests, in accordance with the provisions of paragraphs (b), (c), (d), (e), and (f) of this section, the following byproduct materials in prepackaged units:

(1) 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 byproduct material, or the radiation therefrom, to human beings or animals.

(2) 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 byproduct material, or the radiation therefrom, to human beings or animals.

(3) 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 byproduct material, or the radiation therefrom, to human beings or animals.

(4) 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 byproduct material,

or the radiation therefrom, to human the handling of the byproduct materibeings or animals.

als. (5) Iron-59, in units not exceeding 20 (c) A person who receives, acquires, microcuries each for use in in vitro possesses, or uses byproduct material clinical or laboratory tests not involv- pursuant to the general license estabing internal or external administration lished by paragraph (a) of this section of byproduct material, or the radiation shall comply with the following: therefrom, to human beings, or ani- (1) The general licensee shall not mals.

possess at any one time, pursuant to (6) Selenium-75, in units not exceed- the general license in paragraph (a) of ing 10 microcuries each for use in in this section, at any one location of vitro clinical or laboratory tests not in- storage or use, a total amount of volving internal or external adminis- iodine 125, iodine 131, selenium-75, tration of byproduct material, or the and/or iron-59 in excess of 200 microradiation therefrom, to human beings curies. or animals.

(2) The general licensee shall store (7) Mock Iodine-125 reference or the byproduct material, until used, in calibration sources, in units not ex- the original shipping container or in a ceeding 0.05 microcurie of iodine-129 container providing equivalent radiand 0.005 microcurie of americium-241 ation protection. each for use in in vitro clinical or labo- (3) The general licensee shall use ratory tests not involving internal or the byproduct material only for the external administration of byproduct uses authorized by paragraph (a) of material, or the radiation therefrom, this section. to human beings or animals.

(4) The general licensee shall not (b) No person shall receive, acquire, transfer the byproduct material possess, use, or transfer byproduct ma- except by transfer to a person authorterial pursuant to the general license ized to receive it by a license pursuant established by paragraph (a) of this to this chapter or from an Agreement section until he has filed form NRC- State, nor transfer the byproduct ma483, “Registration Certificate-In Vitro terial in any manner other than in the Testing with Byproduct Material unopened, labeled shipping container Under General License,” with the Di- as received from the supplier. rector of Nuclear Material Safety and (5) The general licensee shall dispose Safeguards, U.S. Nuclear Regulatory of the Mock Iodine-125 reference or Commission, Washington, D.C. 20555, calibration sources described in paraand received from the Commission a graph (a)(7) of this section as required validated copy of Form NRC-483 with by $ 20.301 of this chapter. registration number assigned or until (d) The general licensee shall not rehe has been authorized pursuant to ceive, acquire, possess, or use byprod$ 35.14(c) of this chapter to use by- uct material pursuant to paragraph (a) product material under the general li- of this section: cense in this $ 31.11. The registrant (1) Except as prepackaged units shall furnish on Form NRC-483 the which are labeled in accordance with following information and such other the provisions of a specific license information as may be required by issued under the provisions of $ 32.71 that form:

of this chapter or in accordance with (1) Name and address of the regis- the provisions of a specific license trant;

issued by an Agreement State that au(2) The location of use; and

thorizes manufacture and distribution (3) A statement that the registrant of iodine-125, iodine-131, carbon-14, has appropriate radiation measuring hydrogen-3 (tritium), selenium-75, instruments to carry out in vitro clini- iron-59, or Mock Iodine-125 for districal or laboratory tests with byproduct bution to persons generally licensed by materials as authorized under the gen- the Agreement State. eral license in paragraph (a) of this (2) Unless the following statement, section, and that such tests will be per- or a substantially similar statement formed only by personnel competent which contains the information called in the use of such instruments and in for in the following statement, ap

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