ML20196F581

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Recommends Issuance of Notice of Violation & Transmittal Ltr Similar to Encl to Resolve Concerns Re Unauthorized Disposal of Byproduct Matl Contained in 3M Static Eliminator Devices Acquired Under Provisions of General License
ML20196F581
Person / Time
Issue date: 08/05/1988
From: Grobe J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To: Lieberman J
NRC OFFICE OF ENFORCEMENT (OE)
References
SE682, NUDOCS 8812130305
Download: ML20196F581 (9)
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Text

{{#Wiki_filter:, _ _ _ _ _ _ ,p* og UNef so ST.TEs b m im C e k, NULLEAR CEGULATORY cOMMisslON gfy) c, 3 I aE0104 til C >FA/ 4H-3 i ,ee nooseveu acao o u.. u....,m.. g***** August 5, 1988 _d [ / p p p. p /. / MEMORANDUM FOR: James Lieberman, Director, Office of Enforcement FROM: John A. Grobe Director, Enforcement and Investigation Coordination Staff

SUBJECT:

l'RAUTHORIZED TRANSFER OR DISPOSAL OF BYPRODUCT MATERIAL CONTAINED IN A DEVICE ACQUIRED UNDER THE PROVISIONS OF A GENERAL LICENSE Recently, defects were identified in various 3M static eliminator devices that had been acquired under the provisions of a general license in accordance with 10 CFR 31.5. As a result, the NRC required t. hat all such devices be returned to 3M for disposition. Subsequently, a number of 3M customers vere unable to locate one or more of the devices and reported thee to NRC as lost. The Region !!! staff considered this matter and concluded that the overall radiological hazard to the public was low, regardless of the number of devices lost, and should be considered as a Severity Level IV violation. This is based on:

1) the only exposurc pathway is internal; 2) the polonium is bound to microspheres; 3) the microspheres are not respirable; 4) the microspheres are relatively insoluble in the GI tract, and 5) a large nunber of devices lost would not likely represent a larger individual dose coninitment. After considering various enforcement options we concluded that the best choice would be to issue one Severity Level IV violation for transferring or disposing of these devices in an unauthorized manner, contrary to 10 CFR 31.5(c)(8). We believe that a routine Severity Level IV enforcement action with a boilerplate transmittal letter would l

effectively address NRC's concerns. The response required by the Notice of Violation would address corrective action for those who intend to obtain similar devices in the future and woi1d make NRC aware of those who elect not to acquire additional static eliminator devices. 1 Therefore, we recomend that this matter be resolved by issuing a Notice of Vioietion ar a transmittel letter similar to the enclosed attachments. Each enforcement action will also include a cop;' of 10 CFR 31.5. If you have any questions about this matter, please contact me or Bill Schultz of my staff. it hn A. Gro e, '. rector Enforcement and Investigation / Coordination Staff Attachments: 1. Draft Notice of Violation 2. Draft Letter to Licensee 3. 10 CFR 31.5 See Attached Distribution 8812130305 080005 PDR REVGP NRCTHMCO PDR J

I r o James Lieberman August 5, 1988 4 [ Distribution l ec w/ attachments-R. Cunningham, NMSS [ A. 8. Davis, RI!! C. J. Paperiello, RIII Enforcement Coordinator s RI, RII, RIV, RV l I f

d NOTICE OF VIOLATION General Electric Company General License (10 CFR 31.5) Report No. 88-107 As a result of letter dated April 29, 1988, and in accordance with j 10 CFR Part 2, Appendix C - General Statement of Policy and Procedure for NRC Enforcement Actions (1988), the following violation was idertified. l L 10 CFR 31.5 (c)(8) requires that any person who acquires, receives, possesses, uses, or transfers byproduct material in a device pursuant to the general license in paragraph (a) of this section, transfer or dispose of the device only by transfer to a person holding a specific license to receive the device. Contrary to the above, during the period prior to April 1988, a 3M Model No. 902, static eliminator (Serial No. F32267) containing a nominal 10 mil 11 curies of polonium-210 was transferred or disposed of in an unauthorized i sanner. I This is a Severity Level IV violation (Supplement VI). Pursuant to the provisions of 10 CFR 2.201, you are required to submit to this office within thirty days of the date of this Notice a written statement t or explanation in reply, including for each violation: (1) corrective action taken and the results achieved; (2) corrective action to be taken to avoid further violations; and (3) the date when full compliance will be achieved. Consideration may be given to extending your response time for good cause shown. I i j ) i Dated D. G. Wiedertan, Chief 1 i Nuclear Materials Safety ] Section 1 i l 1 l a i I I 1 [ 1 a ? hal

,,g e. 49 U8dift") STAfts 9 NUCLE AR REGULATORY COMMIS$10N 5 REGlo$d 111 g 5 700 mooltvtLT m0 Ao GLEN ELLYN. ILLINolt 44137 General Electric Company General License (10 CFR 31.5) ATTN: Ron $1eloff Report No. 88-107 Highway 69 Mount Vernon, IN 47620-9364 Gentlemen: This refers to your letter dated April 29, 1988 describing the circumstances surrounding the loss of a 3M Model No. 902, static eliminator, Serial No. F32267 which was received appror.imately March 1987. This device which contains a nominal 10 mil 11 curies of polonium-210 was possessed under authorization of a NRC General License pursuant to 10 CFR 31.5. As a result of the reported loss of licensed material, certain of your activities appear to be in violation of NRC requirements, as specified in the enclosed Notice and a written response is required. The responses directed by this letter and the accompanying Notice are not subject to the clearance procedure of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511. j $1s will gladly dise ~ any questions you have concerning this matter. Sincerely, i l D. G. Wiedeman, Chief Nuclear Materials Safety i Section 1

Enclosures:

1. Notice of Violation 2. 10 CFR Part 31 4

UNITED STATES NUCl. EAR REOULATORY COMMISSION RULES and REGULATIONS Tmg te. cetArten 1. coog of PsogaAt nasutAnoass-ensney 33,34,3 31.1 PART GENERAL DOMESTIC UCENSES FOR SYPRODUCT MATERIAd 31 w accordance em me sp m.rme==>>oes of *et-ua.. easurm.. Uons contained in a specific Deense = saugtna or controutng taletness. den- = y (****,*,*d ",*"us'es. suon.iessage. or,f. ace locauen. r4di. level, in*er m mei, erw.auon d,,te. no-{ sity, Issued to htm by the Commtaalon. uautauve or.mu. a,t, C,e,runn settces and se,ntpment. lJ e,maus, eene,ue ,o,u,,,,e.ta vices designed for use as static altalna.,in lative theinleal compoofden, or for C MB asocevaL tors which contain, as a sealed source U producing light or an 6onised atmoe. sta Coru,im meeeuring saastas er seetrol. H or sources, byproduct t aterial conalsta phers. 31.8 oemeral seense te knetaD devtsee een. 3 ng of a toteJ of not more thar* S00 ami lag ee tems. i erocutift1 of polonium 310 per dettee. (b) The sperallloeme in paragraph seens licemmed In 181 A. e 31.1 tasmineue safets devtses fee use la air e* (bMe) (Reserved) (a) of this section appues on ly to by. (d) ton penerst(nr tube. Dertoes go. product material contained L.) devlees 31J A*enes,wa-341 to me twm et estibra 2 ersti-signed for ionisauce of air which con. which have been saanufactured et kl-use er re erones seurosa, tain, as a sealed scutoe or m'm by, o tatur trsnaferred and labeled in.on. ae i stJ oemeral skenee to own byproduet ma-product material consistir s of a total -r ~e eth me sp-inesuem a ,1'yate,e,alb,e,,se,e,,,,ooum,,,, of noi ino,e man wo microwns of tained in a specifle beense lasued pur. polonlum 210 per device or of a total of not more than 50 millleuries of hy. = suant to i 33.51 of this chapter or la see eesecues dernesa tocordams with the specifications 31.11 Generst license fee use of brproductsnatenal for eersta te vtsro almical se ~drogan 3 (tritium) per devloe, eentained to a spectfnc incense lesued by an AgrMment State which author. innerstery teaume. 'g gg,4 g ng,,, nets.e e.gge,tsee gegeg,,. sons gen.rstly ueen.he dettees to per. hies distribution of t >t m.. ended (a Us C nit ain.Andnestry Sees et.tet tes. es Sut sat,

    • m Ob(5 *Peri ed by the w

.e (a) The Nuclear Regulatory Commis-y.ent stata.

.ul c art. as amendet sat es sat alon haa submitted the intormation 1:41 se amended t344 (a US C nett, a442).

coUection requirements contained in = Secton #14 le slee lesned under sec. 2?4. (c) Any person who acquires, re-2 this part to the Office of Management cetten, possesses. uses of transfers by. . rl Stat ese let USC acett and 3tudget (OME) for approval as re-2.yee the purposee of see. 321. se Stet saa as quired by the Paperwork Reduction product material in a device pursuant s end*4 tu USC 3273k ll *1*eXtH3) h and (8Hek it4(ck it 11(bk and *ttstbk (sk Act of 1980 t44 UE.C. 3601 et moq.). to the general Ucense la parsgraph Ia) a i O OME h)a approved the information of this section:

and (d) are toened under eer. teth. es Stat.

(1) shall aneure that au labels al-e*a u emended (a Us C asettb1t as o een,et,on requirementa contained in itsed to the device at the time of re-li tt4(eN4k (sk and (st ead tt st(bl and (e) G this part under control number 3160-cetpt and bearing a statement that re-are tuaed under see, ttte. 88 B(at sec. as [ 001s. (b) The approved infermatlon coDec-moral of the labal is prohibited are ,, amended (42 UAC aantelk tion requirementa contained in thle maintatned thereon and th&L comply I with au instruettom and preuuoce part appear in il 31.5. 31.8. and 31.11. *I provided by such labels; "I 31.1 Purpose and es*pa. (c) This part contains Information This part establishes genert! Ucemos coDeedon requirements in add.ttion to a (3) Shan assure L5st tae device is l 1, for the posseaston and use of byprod. tested for leakage of radioactive mate-control 'l rtal and proper opersuon of the on off those approved under the 0 uct material contained tn certain items number specified in paragraph (a) of s and a geners] license for owTierahlp of this seedora These information conec-mechanism and indlestor,if any, at no

  • hyproduct material. Part 30 of this Hon requirements and the control longer than sis.montt. intervals or at I chapter also contains proviatone appu.

numbers under which they are ap-such other intervals as are specified in cable to the subject matter of this Proved are as foDows-the label; howeven part. (1) In 131.11. Form NRC-483 is ap-(1) Devices containing only krypton proved under control number 3190-need not be tested for lestage of rs- = dioacuve matertal and F0 SlJ Teruse and e**dttlead-_00M. (D) Devices containing only trittum (a) The generallicenses provided in.0 314 Certala messaring, gausing er e*e> or not more than 100 microcuries of = j true part are tablect to the procalon troillas d*,4csa.' other beta and/or gsmma emitting of Il 30.14(dt 30.3 4(a) to (e). 30.41 material or h 20J1 to 30 33 and Parts 19. 20. and 31 (a) A generallieense is hereby tatued a

  • of 'his chap.eri unless indlested oth.;.; to commercial and industital ftrms and Lerwtw in line language of the genersl research, educauonal and medics 3 in-

'st!!utions, individuals in the conduct ticense. ! of their businees, and Feders!. State or < a local government agencies to acquire. 931J Cerhin devices and etely.eak ' receive. posseaa. use or transfer. In ac-A general license is hereby tasued to cordance with the proMalons of part. p transfer, receive, acquire, own, poucos graphs (bl. (c) and (d) of this section, e and tue byproduct material incorpo-byproduct material contained in de-ei

  • rsted in the folloMas dedees or equip-vices desjgned and manufactured for I ment which have been manufactured.

l sysroona penaentns byproevet matettaJ in l tested and labeled by the manuf actur. 6,ne.e un4er ee senero aceue to i n2 before Jarl,15. tett. mar comune to pce- ' Attention is firected seruculartr to Oe seas, use or trstafer that tr.ateria.1 to accord-provtstone of me rugslauces in Part to of nace with the requitetsents of $ 314 In SMa chaoter wrJch reiste to the labellne of af feet on Jan it. t914-ecetannere, October 31,1946 31 4

e 38MC) 31*5(c) PART 31 e OENERAL DOMESTIC LICEN8ES FOR BYPRODUCT MATERIAL 10 microcu+s of alpha emitting material mission Inapection and Enforcement i 31.6 Ceneral license to lastaD devices and devkes head in storage in the original Regional Office Listed in Appendix D of generally licensed in g 31,5. ahipping container prior toinitialinstate-3"Part 20 of this chapter, a report contain-g, g tion need not be tested for any purpose;fing a brief description of the event and E license tasued by an Agreement State (3) Shall assure that the tests requiredg the remedial action taken; by paragraph (cK2) of this section and (6) Shau not abandon the device ; authorhing the bolder to manufacture, [ install, or service a device described la other testing, instaustion, servicing, and ntaining byproduct material; .1314 within such Agreement State la i removal from instaHation involving the ' hereby granted a generallicenas to radioactive materials, its shielding or *; (7) Shau not export the devnee install and service auch device in any containing byproduct material except in non. Agreement State and a general cr,ntainment, are performed: g acceehnce with Part 110 of this license to lnatall and senice auch device I J (1) in accordance with the instructions " provided by the labels;or 7 chaptu,. In offshore waters, as defined in a I i 150.3(f) of this chapten trorided, hat: F) by a penon holding a specific '~ (8) Except as provided in paragraph ~ f bcenn pursuant to Parts 30 and 32 of (cX9) of this section *haU transfer os 2 this chapter or from en Agreement State dispose of the devke contelning by p- (a) (Deleted 39 FR 43531*) to perform such activities; (4) Shau maintain records showiris product meterial only by transfer to a I person holding a specific license pursuant compliance with the requirements of to Parts 30 and 32 of this chapter or from u *'# paragraphs (cX2) and (cX3) of this uc* an Agreement State, to receive the device

  • W tion. De records shad show the results of and mithin 30 days after transfer of a b#

^8" ' * # ** tests. The records also shau show the device to a specific licensee shaU furnish dates of perforrnance of, and the names to the Dtrector of Nuclear Material Safety I (c) Such penon assures that any labels of penons performing, testing, installa-Comminion, Washington, D C. 20555, a le regulations of the A and Safeguards, U.S. Nuclear Regulatory required to be affixed to the device under tion, servicing. and removal from installa-tion concerning the radioactive material, report containing identification of the ! heensed manufacture of the device bear a its shielding or containment-device b) manufacturer's name and R statement that removal of the label as Records of tests for leakage of radio, model number and the name and address brohibited. activ e matenal required by paragraph of the penon receiving the device. No (d) (Deleted 39 FR 43531.) (cX2) of this section shal' be maintained report is required if the device is trans-g 31.7 Luminous safety devices for use for one year after the next required leak ferred to the specific bcensee in order to in aircraft. test is perfonned or unid the ualed obtain a replacement device; (a) A general licenu is hereby issued source is transfened or disposed of. (9) Shall transfer the device to to own, recche, acquire, possen, and use another general heensee ordy: g Records of tests of the on-off mechanism g tritium or promethium 147 contained in y and indicator, required by paragraph (1) Where the device remams in use at , (c)(2) of this uction, shau be maintained,ga particulu location. In such case the luminous sa fety devices for use in aircraft, provided each device contains

  • for one year after the next required test s transferor shat give the transferee a copy not more than 10 curies of tntium or 300 I of the on-off mecharusm and indicator is 8 f this uction and any safety documents em0heunes of promethium-147 and that perfonned or unta the sealed source is identified in the label of the device and 5each device has been manuactured, mWn 30 days of the transfer, report to transfened or disposed of. Recordi uhkh the Director of Nuclear Mitenal Safety ;anembled or initiaUy transferred in m

are required by paragraph (c)(3) of this accordance with a beenu issued under section that be mamtaaed for a penod and Safeguards, U.S. Nuclear Regulatory 'the provisions of l 32 53 of this chapter Commission, Wa shingt on, D C. 205 55, of two years from the date of the or rnanufactured or assembled in ac-the manufacturer's name and model recorded event or untd 16 ice is cordance with a specific license issued by transferred or disposed of. number of device transfened, the name an Agreemert State which authorues = and address of the transferee, and the manufacture or suembly of the device (5) Upon the occurrence of a fadure name and/or position of an andriidual for distnbu tion to persons generau) of or damage to, or any indication of a who may constitute a pomt of contact beenud by the Agreement State. Possible failure of or damage to, the between the Commission and the trans- = shield'- ' the radioactive material or feret,or (b) Persons who own, receive, acquire, the c,. - mechanism or indicator, or (ia) Where the device is held in storage , possess or use luminous safety devsces upon ti...etection of 0 005 microcurie in the ensinal shipping container at its lipursuant to the general license in this or more remosable radioactne material, intended location of use prior to initial Maection are esempt from the requirements , shall immediately suspend operation of use by a general beenue f of Parts 19,20, and 21 of this chapter, the device untd it has been repaired by Iescept that they shaU compl) with the a R the manufacturer or other person holding I (10) $haU comply nith the provisions proitsions of { { 20 402 and 20 403 of a specific beense pursuant to Parts 30 and j of { { 20.402 and 20 403 of this chapter this chapter. 32 of this chapter or from an Agreement gior reporting radiation incidents, theft or State to repatr such devices, or dispond gloss of bcensed matenal, but shall be j of by transfer to a renon authonzed by a o esempt from the other requirements of specific bcense to re6ene the byproduct { Parts 19,20, and 21 of this chapter. rnatenal contamed in the device and' C (d) The general beense m pungnH*p g g devices containing tntium or pro-mithin 30 days, furrush to the Director of R a of this section does not authorue 1sRgethium 147 the apprernate Nuclear Rerw1 story Com * (m)anufacture or import of devices {contatnmg b> product matenal Septembe 1,its2 38 2

e 31.ll(s) 31,7(d) PART 31 e GENERAL DOMESTIC UCENSES FOR BYPRODUCT MATERLAL detection devims, pro 4 sed asch device I (d) Th6s general license does moth the storage containee, bears a label which contains not mon than fifty ankrocuries 5 authoeite the expoet of haminous esfety5 includes the following statement ce a of stronthia>90 and each device has been [8, devices containing trititum or pro ! mabstantiaDy simuar statement wh8:h matefactund oc ksitiaDy transferred in A contains the infoemation ceded for la theaccordesco with the specifketions j . methium 147. In. (foUoming etatement contained la a Ucense issued pursuant to The www, some=We,== and e eerw et.2 l 32.61 of this chapter ce in accordance (e) Die general hcenas does act th oovree, Wodel....... Serial No...... S with the specifkations contained in a

== 18*** **4 88 t'eul* a '" '"H8 88 8 s'*"s*tatu Nuclew Resulatory h specifk license bsued to the manufst-nuthortae the onmership, receipt, acquisi. tions of the United tion, possession ce use of promethium-Commien6on a of a siete win makh me " turer by an Agreernent State ehkh 147 contained in instrument dials. Comahnson hee estered into na ureement re' outhorizes manufacture of the ice detec-neuhtort authority, Do not tion devkes foe distribution to persons l 31.8 Asterichsas.24) in the foesa of {

  • noe seneraDy licensed by the Agreement calibestion oe refenace sources, g

W ATE RI AL. ,,, State. (a) A general license is hereby issued. p AUTION. RADIOACTIVE THil $OURCE CONTAINS AMERICtVW. to those persons listed below to own,' 241. Do NOT TOUCH RADIOACTIVE neehe, acquire, posseea, use and transfer, PORTION OF TH18 50VRCL in acCoedance with the provia}ona e,g possess, use, or transfer strontium 90 persgraphs (b) and (c) of this section, (Name of manwrectwrw o' contained in ke detection devices pur. , americham 241 in the form of calibration, l'""*I ' '""" I maant to the seneralIkenw in parssreph 2 or reference sources: (a)of this section: E (1) Any penon in a non Apeement ' State who holds a specific license issued (3) ShaU not transfer, abandon, or (1) Shad, upon occurrer.ce of visuaDy punuant to this chapter thich authorizes dispose of such source except by transfer observable damage, such as a bend or him to receive, possess, use and transfer to a person authorized by a bceme crack or discoloration from overheating, byproduct material, source material, or pursuant to this, chapter or from an to the device, discontinue uw of the Asteement State to receive the source. devke untD it has been inspected, tested special nuclear material; and (4) Shad store mach source, except for leakage and repaired by a person (2) Any Government stency, as de. when the source is being used,in a clowd' holding a specific license punuant to fined in 6 30 4(g) of this chapter, which container eder;ustely designed and cons Parts 30 and 32 of this chapter or from holds a specific ticense iseued pursuant to' this chapter which authorires it to structed to contain americium 241 which an Agreement State to manufseture or eccebe, possess, use and transfer by. might othermise escape during storase. servke sach devkes; or shan dispose of product material, source material, or (5) Shan not usc such source for any the device punuant to the provisions of purpose other than the cahbration of l 20.301 of this chapter; special nuclear material. radiation detectors or the standardustion (2) Shau aneure that au Isbels affined (b) The general license in parsgraph f other sources. to the device at the time of receipt, and (a) of this section applies only to calibre-(d) This general lkense does not which bear a statement shich prohibits tion or reference sources which have been *in g authorue the manufacture or import of removal of the labels, are maintained manufactured or tnitiaDy transferred vaundon M nfennu s urcu contain . thuton; accordance with the specifications 6 ing americiurr>241. s . contained in a specific beenu lesaed. of this 3 purasant to i 32.51 of this chaptsr ce in authorire the export of cabbration or F rnents of Parts 19,20, and 21 g accordence with the speelfications p contained in a specific license issued to l 313 Gennallkenu to own byprodunN ll 2001, 20 402, and N403 d M autho es m nu e r f material. ( chapter. >>urces for distribution to persons gener, A general Lcense is hereby issued to * (c) This seneral licenu does not g aDy bcensed by the Agreement State. omn byproduct material without regard B authorue the manufacture, assembly, dis-l= (c) The general I cense in paragraph to quantity. Notsithstandtrig any other n I' "I" ' " chapter, a ge neral * "*" (a) of this section is subject to the provision of this this paragraph is not W peovisions of { { 30.14(d), 30 34 (a) to bce nsee under (e), and 30.51 to 30 63 of this chapter, authorized to mar.ufs:ture, produce, " I 3 fb-c [t I **"" vitro , and to the provisions of Parts 19,20, and transfer, receive, pcuess, uw, irnport or (o P g 21 of this chapter. In addition, persons export b> product matenal, except as ga h wypuW authorued in a specific bcense. (a) A generallneense is hereby tuued 7, sho own, receive, acquire, possess, uw and transfer one or more calibration or O to any ph>sician, seterinartan in the 'T reference sources pursuant to this general,,6 31.10 General beenu fot strontium-90 a cal laborstory or hospital to retehe practice of seterinary medietne, citni-m i in ke detect 6on deiket hunw: j (a) A geners! liunse is henby issued l acquire, possess, trsnsfer, or use, for e, seg tre, poswu, uw, and. an, of the foliosing stated tests. in ae-co O (1) Shad not pouess at any one time, E g at any one location of storage or use, a' *rsnsin struntiumM contained in in gTaphs (bh (CL (dL tet and (f) of thts to os s more than 5 microcut,es of amencium-section, the follosing b> product mate-rials in prepackaged units' sw R 241 in such sources, ,'W'cn genereur taenus vndet snis sec. (2) Shall not receive, possess, use or g transfer such source utdess the source,or J S *'8 8 ' 8 " 8 ** 8 ** *' la tits "*" P"* "sa'"the resusuens en owthorbi errect on Janven i, sets, g i 33

PART 310 GENERAL DOMESTIC LICENSES F2R BYPRODUCT MATERIAL " (5) The general Leer see ahall' dispose (1) Has filed Form NRC-443. of the Wock fodine 125 reference or "Registration Certificate-In Vitro calibtation source described in paragraph (I) lodine 125, in u-na not exceeding Teating with Byproduct Material Under f (1) (7) of this section as required by 10 microcuries each for use in in vitro General Ucense." with the Dtrector of D 20.301 of this chantee* ' clinical or laboratory tests not involving Nuclear Material Safety and Safeguards. U.S. Nucleer Regulatory Commission, Internal or external administration of Washington. DC 20555 and received 2 (d) The general licensee shall not re. the radiation Efrom the Commlaston a validated copy 3 ceive, acquire, poasess, or use byprod . byproduct material, or R therefrom, to human beings or animals. ';of Form NRC-483 with a registration [ uet material pursuant to paragraph (al (2) lodine 131, in units not exceeding number assigned; or .of this section: 10 microcuries each for use in in v',tro (2) Has a license that authorizes the i clinical c. laboratory tests not involving medical use of byproduct material that h hternal or external administration of was lasued undu Part 35 of this chapter. (1) Except as prepackaged units byproduct ma terial, or the radiation ~ mhich are labeled in accordance with the therefrom, to human beings or animals, provisions of a specific license issued under the provisions of i 32.71 of this ~ (3) Carbon 14, in units not exceeding

chapter or in accordance with the provi-

,,10 microcuries each for use in in vitr

sions of a specif e license issued by an I

J clinical or laboratory tests not involving & Agreement State that authortres { internal or external administration of

  • manuf acture and d ist ribution of

' odine 125, lodine 131 carbon 14, hydro-g byproduct material, or the radiation i [ therefrom, to human beings or animals. gen 3 (tritium), selenium 75, iron 59, or Mock lodir.e 125 for distribution to ~ (4) Hydrogen 3 (tritium),in units not persons sentrauy lice.ised by the Agree-exceeding 50 microcuries each for use in P "I b'"* in vitro clinical or laboratory tests not involving internal or external administra-(2) Unless the following statement, or y tion of byproduct material, or the radia-a substantiaDy simUar statement which g tion therefrom, to human beings or (c) A person who recebes, acquires, contains the information caUed for in the f 8"I* "I possesses, or uses byproduct material foUowing statement, appears on a label (5) Iron 59, in units not exceeding 20 pursuant to the general bcense established affaed to each prepackaged unit or g microcuries each for use in in vitro appears in a leaflet or brochure which clinical or laboratory tests noi involving { by paragraph (a) of this section shan accompardes the package: internal or external administration of;; comply with the following: (1) The serietallicensee shad not pos-This radioacthe material ma> be recened. byproduct ma terial, or the radiation acquind. posseued. and used ont) b> ph>sb therefrom, to human twings, of animals.E sess at any one time, pursuant to the cians setermariarts in the practice of seiert ,, general license in paragraph (a) of this s nar> medieme. cimicallaboratories ot hospo y section, at any one location of storage orI tais and ont> for in utro cimient or labora (6) Selenium 75, in units not u se, a total amount of o me 1 tor) testa not insolur.s Internal or enternal e .i exceedmg 10 microcuries each for use in iodine 131, selenium-75, and/or iron 59 stion therefrom to human belns: or ant admmistration of the material. or the radi-in vitro clmical or laboratory tests not "h innobing internal or etternal administra jn excus of 200 microcurin Ind ir)lf$r arYs7tNtN t$e rey IIiiors tion of byproduct material, or the radia ~ and a s,eneral license of the U s Nuclear U () genus liunsu thaD ston the g,,,i,t 73 com,m, ion or of a state sith tion therc' rom, to human being or by product material, until used, in the shich the commluien hu entered into an original shipping container or in a con, s{eement for the enercise of regulatory su tainer prosidmg equivalent radiation (7) Mock ludine-125 reference or cabbration sources,in units not exceeding protection. <Name of Manuf acturer> 0.05 microcune of iodine 129 and 0 005 (3) The general licensee shall use the n t product materut ordy for the uses microcurie of americium 241 each for useh au)thorued by paragraph (a) of this sec-e in in vitro chnical or laboratory tests not 7, invohing internal or enternal admmistra It'I "- ' tion of b> product material, or the radiay W gennal hansn thau not Etransfer the by product material encept by tion therefrom, to human beings or anirn Os. transfer to a person authorized to receite it b) a bcense pursuant to this chapter or from an Assument State, nor 'ransfn )(b) A person shall not recehe, = acquire, possess. use, or transfer the b) product matnial in any mannu E 3 product material under the general other than in the unopened, labeled A cense estabhshed by paragraph (a) of shipping container as recebed from the i g this section unless that person: a:ppher, q (Mit remoud 49 F R 19423) October 31,1986 3t.4

1 r 3,. PART 31 e OENERAL DOMESTIC UCENSES FOR BYPRODUCT MATE 4tAL ~ (e) The registrant ;-r ' '_- or using byproduct materials mader the general 16 cease of paragraph (a) of this section shall report la writias to the Director of Nuclear Meterial Safety and Safeguards g any chances in the information furnished g by him la the "Registration Certificate-la Vitro Testias With typroduct Material Under General LJeenee," Form NRC 453. The report shan be furnished within 30 days after the effective date of such _ danse (f) Any person using byproduct me-terial pursuant to the general literue of paragraph (a) of this section is esempt from the requirements of Parts 19. 20 and 21 of this chopter with respect to byproduct materials covered by that I general license, except that such persons " usins the Mock lodine-125 dewrit<d in h paragraph (a) (7) of this section shau

  • comply with the provisions of ll 20.301, 20 402, and 20.403 of this

_ch ap ter. I 31.100 (Deleted 36 FR 16898.] 35 Jwwa'Y 31,1945 (tsees)}}

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