ML20080Q447

Findings of Fact & Conclusions of Law.Certificate of Svc Encl

ML20080Q447
Person / Time
Site:	Callaway
Issue date:	10/06/1983
From:	Jeffrey Reed REED, J.G.
To:
References
NUDOCS 8310120420
Download: ML20080Q447 (10)

Text

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U :ITD 'STAE .0F M JtICA - .- ,

'ITCIE31 REGULATd!Y CCWIUSION l ,. - '

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4EFORA TriB iTs$1C '5AFeTT AIQ l.ICFSIJ:G ,00ARD DOM ETED s:.

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, ' UNION KLEC~il!C CTPAhT 3

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{.- 'D.:&ct No. STN 5[483 PPT 11 Pl2:13

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- FINDI';'JS OF FACT n!D CCHCllUSICES OF 1.AW

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eII;NG3UCTION

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. Pursuant to Board' Order, ' dated 11. Augant 1983, a hearing das h.Qd .

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,.'. . Or . .. ? ,0 , =.% .'. .. ...v in 7diton', }iissourii on 13fSeptember 1983 Eor li.ho 'purpo$e of adjudication

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O of Reed Contentions 6 and 16. 7,The Applicyt ud the !?.C Stoff prescated

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4..? witnesses; Mr. Reed did not offei witnsesos. The following findings of c.+

{ fact and conclusioni of law arsforwarded in cortp31ance with tbc 3 card Order ie' sued d that h' earing. ' s O.

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Interven'of Reed's Contefit.ibns 6 and 16 relate f.c the need for .. . .

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., - predistribution of. potassium iodide (EI,).,. to , .

e.e.rgency workers and the E

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, deneral public that reMies 4 thin the'?lume Expoeub Pat;hway F,r.ergericy

'f. Plenning l' one (PE? EP/,) md the' absence of adequate instructions rchting

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V' to protective'actio.99-to bc taken by said residents in the event of a e release of radic-n4cil.les during 4 nuclear acwer plcnt accider.t.

.h The Sttke of I'isacuri'has, since thle insre hr.s been raisa,1, rr versed its ariginisl. str.nd an<1 ordered"issua:$ce of 'KI to eneri er.ey uoricre. This e

l' portion of Reed's contention has been hatinfrctoril/ renolved and is no

. longer cc M aered at 'aeus.

The t:Itc of Mi nsc tiri has nct, ardored j n nasme m' KI to t.he publie ch56 8310120420 831006 PDR ADOCK 05000483 G PDR 3

1 2-residing within the Pf.P EPl., nor provltia<t effective means for respiratory prot ection ag;ainst r*lienuclides ra} eas':d to the stic.osphere in the event of a serious accident at tk.e Callawny :>1 ant !;o.1; to include protective

.cacuros to off-sot thyro'id damar.e-frfc.' rhdio-lodir.eu. '

The Food and !) rug lehirdstrition ha9 cov. M i'd Q at the r$cks from short-tire une 'of relatively low d6ses of KI for thyroid blocking in a radiological e:nerrancy are outwexched by the ririke of radioinc.ine induced thyrcid nodulca or cancer at the recjecte'd ' dose t a t'r.o thyroid of 25 Ren.s cml reco.r.r,encied doses of KI at 130 milligrams (ng) a day for adults and children 'above 1 year of c6e and 65;m6 Per. . day for. infants below th.e age of'1 yehr 'ha ad ainistercJ M a radiation emergency. The Food and Drug '

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, . Administratio'n (FDA), has further coheltided thst .at such doses, K1 is safe t'

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.', and' effectiire and has authorized KI, in the above doses, to be manufactured i , .

, and distributed as .a' non-presc'r iption drug. The "non-prescript, ion" status

. places said-drug outsido tLo needs for medicrl control' or sup'crvision. It

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,, is sold with instructions for use clearly printed on ~the packaging or duly 3 -

enclosed within nald packaging. Such usage. instructions meet FDA criteria

, or the drug will not h9 authcrized -for sale.

Applicent witnesses repeatidly cited'the facts above during the hearing on 13 September 1983, and repeated sur.e in its Proreced Findings of Fact and Con'clusions of Law;' however, it has attacked said PDA findings with testimony. relating to "riske", "use .for non-intended purposes, " inducing a false sense of secarity 'n the public", " uncontrolled administration of KI without medical supervisien",'"h greater riek of the likelihood of, and a dim'nished ability to resrond to adverse. reactions". Such attacks on FDA

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~r.ules.,'veguDtions, or any provision thereof should nok be permitted by-the r,

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t. a ~ Nuclear Regulatory Comadssion or'any othes Federal Agency in any.adju,dicatory -

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' proceeding by %ny party thereto. ' The Conwdsnion does not. permit such attacks.

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. on itsfrules, regulations, etc.~ (seee 10'CFR'. Part; 2, Seetion 2.758 a).

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. . The. pareceters' for, safe use and distidibution' of ,KI has been established

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.J Aby the - 1 FDA. It h,as been foundLtO< be' "s'afe and effective",as a'radiciodine

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n blocking-agent c,.the. . . . >

doses fo,r .which meritLfacture,, a ~ u p~ackaging and per. -the . .

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C count'er sale,is.:adthofised.. %,; W . *,.

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. Mr. . Reed' used NRC.. study data (NU_ REG /CR-0388 SAND 78-0269)' toyete3mine g ~. .

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potential'  ;- dud.learOea[ - . - -

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c.ould' result' inimajor releas.es of ~

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theyq pxttacted',frors. attack by:wayM discoyery;.preo.fQ&rgument,,.pr n,.;:.m L ,,y ,

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subject.to,10 CFRs Pqrt 2bSe,ction 2 -e758N.N9L.,

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fa;ilure at lp.minuteec '-

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after: the start of.,.x the accident;.with aliiiom,e.;.c, con #qntrations - of radiciodines ;.,,

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shollhr, 16 minut,'eh releashd.,cumul$ti

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ahtivitylin Curies is 13x106 ,, , ,

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' 4' hours from start of accident activity > in:Curi~es is Lix10.7.;

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'.b 26 hoss .fr c a. .s. t. art. o,f a. ccid,e.n, t. activity in, Curies id 4. Jot 107 .

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The projected dose tc the thyr 61d some.lO. hours.after the accident has l t .- .

. begun md.at; a distance d'omwind froza tho' plant of 59 milee ~is about ID. r.$ 7 n

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re:::s and Nhile' below the ProtecIive Action Guides for wiiole-bodya'nd lung,

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'the thyrcid. 'It is'reaschable to . assume that because of deposition .of -

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indicnted for more: distant populations. "

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Because of the rapidity of' this release, and. a'Ib. ,a,,sitmed s realisOM ,

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.' n descriptions 'of circumstances And. radiosetive material release progression, p,, . ,

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4, ,it infrusanable t6' , assume .thatGrolongedicheiter would be the only optign '

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e' expected to exceed 25 Rem within the PEP EPZ %h use' of KI would be i.1

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' acconiance iwith'F3R usea'ge inMuructiqns. " Adcident descriptims III,- IV and ~

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2" 'and p'rudent. 4Use of'respiratort protectioni even ad hoo devices; will hel..p. J

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? - - . u T. ingestioE of',r ndionu'clidos, bdt i to assume 'that lab 6ratory test result [l for '

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,;.ad hoc devices will/ayip],y undaE, actual res.i 6eni,ial .us,egge is a falso '

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( assu: ptico. Mr. Yeal'Slaten, Gitness' for the Applicant, did not obtain' a -

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p,i good face.~ sealon.awil1%gsubfe.ct during?a 'demonstratitra at the" hearing - ,

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- 7 i-K. , ,, . cited abo, ve. . Mr; S1'aten yns even unaware that such " failure to seal" had

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, oecun ed. a,nd,;had toi,be.. advised b.V, the subj.ect .of the' denionstrat. ion th. at a major leak in the respiratory device had occurred. Had, this been a real Q situation, wherein a perent was holding a device ov cr a child's face, the '

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factor Wd ynot ,cxist. Mr. Slatyn,, in hie'tepti2nony,-

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jetatedithat combining shelter, respiratory protection and ingestion 'of K1 i-

' affoided more protection than did shelter and nd hoc respiratory devices, r- . . .

-The NRC hss estab11eLed tha over t1! objective ~ of eergeracy plats is -

to provide doso sav!nce (and in 'som c.nes Infmdiate life saving) for a spectruia of accideats that could nroduce offsite doses in excess of' PAGs

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( ZtEG C654, g) 6; lines 10 through 13) and further, that "the ability to. best reluce notentirtl e;q osure under specific conditions during the' course of"an accident should determine the appropriato responseu (guagg 0654, page 9, lin'es 17 through 20). .

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The-NRC has,' in granting licenses to ~ operate, final authority' to

- " protoot the public hdalth and safety. Tteliance upon input from other

. . ,  :. w Federal agencies'such as F.E.M.A., F.D.A.,' E.P. A. and others is appropriate.

. , [' ,' The Environmental Protection Agency has dotormined that homes suitable for, ,

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rt winter habitation provide respiratory protection for about 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />,(see ' '

,LJ E, Reed Contention $ 6 and 16). The Food and Drug Administyation has deemed '

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9) EI t'd %psafe and~ offective as a thyroid blocking agent in radiological i emergencies, and authorized its scanufacture, distribution and sale, as a o non-pr'escription' drug in designated doses acconpanied by epecific instructions ,

on use. To accept rsdi. cal tpstituny which opposes theso govenunental findings cenotitutes an action that the Cccruisalon does not permit with regard to its .

!, own rules,,regulati'pna and related findings. N u;

,# ,., ' Potassium iodide (KI) is readily available on the market, today, at a .,

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price of $1.00 for a la day supply of pills for 1 person. The pills are guaranteed to have a chelf life of 3-5 years by at 1 cast one manufact.urer (CBhi), making the cost of predistribution of KI to all families residing in the PEP EPZ for Callaway 1.only $17,094.0b (using populati<n figures in

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., the Callaway P3 ant Radiological horgency hesponse Plan, Rev SA, 2/83).

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Prorated over the 5 year period, the cost is only $3,418.80 per year.

Such costs are within'thF limits' of cost / benefit parameters set by the Concission at 40FR19439. ,

III. SUM M Y

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Federal guidance on issuance of KI to the general public and others '

is non-existant; instead, Federal agencies who are responsible for the l[ -

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. phtection of the publfp health and safety in the event of an accident at

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' nucleaz' power wa'ctors .have left such decisions to the sever &l States.

The Nuclear Repilatory Comissica, thr Federal agency with expertise t' , in nuclear matters and authority to grant operations licenses for nuclear

~

power reactors (produbtion and utilization facilities) have done studies 4- which . indicate that seriets levels of radioactive iodine can be released c from pressurized water reactors during severe accidents (those beyond' ff*

r> . " design' base accidents") and that radiaticri deees to the thyroid (due to' ingestion. of radio-iodines) can exceed E.P.A. PAGs for tens of riles t '

down ' wind from th'e plant.

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The Food and' Drug Adninistration had determined that oral intake; of KI is cafo and effecC-c as a thyroid blocking agent during radiological

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energencies. Further, the FX hrs authorized KI to be n.anufactured, distributed and sold over-the-counter as a "non-prescription drug" (sold to the public without the need for medical control or supervision). In light of such' Federal poterminations, all testinony in conflict thereto

.i .should be considered a radical attack upon a duely constituted and technically qualified government agency, an3 be re,}ected by the Board.

Use of shelter u a protective naasure againt,t radio-iodines is 31ndted i

to not more th'an 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> by the Environfr.cntal Protection Agency and such ddif#N.. 0,'iii(.,.-N h N'*] ,y _

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I # Test $rrony from Mr*. Ueal Slaten has shown that use of no hoe respiratory.

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devices is more Mifficult in actual practice than it appears, alse, that. .,

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][ ',the beet' protecti<n afforded to individuals exp'osed to . radio-nuclide's f _

.during .an accMent is shelter, ingoetion obKI,,and the use of respiratory

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>6 p't6tqcdv:e reasures (nd hoe restdratory devices op maske, etc.).- v ,

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. . , , p ' j T4stimony of Dr. Roger E..Linnencnn, K.D.. during the hearir.g showed'. ,. , , .- . .m.

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"'that ' citizens who were not in medical facilities, nursing homas, or State ' " '

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'institut$ms should be afforded s the protection of KI,' it. they were attended -

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[Nu ses).A-In these' casesh the institutionsto'which.thh, pitients were

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.cm. fined were,Jin . fact, their homes.

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' .No'seridus ' problem exists in' pre-distribution of KI within'..the PEP EPZ.1 '

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p , ' t Residets number'1ess than 18;000.and the . cps.t, : for a 325. year supply -(10 day;.

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supply)m .. g ..yforL.each ' person will cost 41.'00..

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.[, . 95 ye;ar' perigd[for th0 entire PEP EP2 is onp $3,4.M.80(

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m Twell. ylthin-the cost / benefit criteria est?bliobed by' the Com:r.lsaien.

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Based upon alltfacts rulatir.6.t o: this. is'aue, the deteradnetiant to; ordoi f.J , .

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'EP. ',. id. .not$. dM.ereh. .byd,3 N i

,= # . , ' ,9 l's.i. ssu.ance. ' of KI' to'.populhticas N. .Ni.i'n. t. he .P.EP medical'

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f ". . .. ,j' . g lor [loggiticil reasons, nor;$s'th'6)e 'a) valid.co'st/ benefit .isase.raieod. ,

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-1 . only, poten' t ial hindekrice. would appear to ye pq11ticaleiri nature. . ;The. question . ' .

- . M.."- i rai' %.sed- ist "Ho, w will the publ~ilvieO n6cle..,ar. .pcNer safnty if:they hate'KI. . w -

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. {p. .in Jro,nt of their faces as th sy.open. their rudicine cabinets each mortiing. .

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to' shave or put on trade-upP. ' Additionally, there may be cencem that the

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e. ..o . . " ..IV. CMCLUSIGS OF LAW .

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'adopteMor,;.othArwibe ' addressed ln this decision :have been found to be i '

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• Based upen a review of the entire t m.. .w . .

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. Mrec$rMirbthig~ p'roceeding opinitin~and findings- toftfEctfthe Boafd', enters /

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t will. be; takenato properly info &the publid .of defensive? actions .needed '

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., nWity respect.to mac.ters placed in cor.troversy by Reed Contention 6, ,

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.a there is reas.:,nable doubt that adeqmte. protective traasures con be takon" .

in 'thejvent of.a catastmphic accihnt -(oxceedirt desigt based accidents) .

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license for a utilisation facility, and the Board hass made ,f;Lndings of.

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Eenclusions. of law on'all matters in controversy. The Board

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,has'. ._ determined that a serious, safety matter exists., pee,,10 CFR, Section s ..

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• Having dbeided this matter :in favcr of. the Intervenor,' the Board

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, . e %b h withholds its authorization for the facility operations.until such time '

," . t -as tilis safety related : matter'is- satisfactorily resolved. '

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Re. cetfully submitted, 4, _.l Y' ' -

_. Dated at Jingdom City, Jo!.n G. Reed .

Missouri,ithis 06th day Citizen of the United States of America c of 0 '9tober 1983. RFD fil j

- Kingdom City, MD. 65262 _

.s tel: (314) 642-2769 T'

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,; y NUCLEAR r:LGULA'iOT:Y COWIST. ION ,

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BEFORE THE ATCMIC SAFETY AND LICEf SING BOARD ' ..

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.Inrthe Matter of ) .

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< UNION ELECTRIC COffANY ) Docket. No. S'm 50-463

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'(Callaway' Plant, Unit 1) ' '

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CFRTIFICATE OF SERVICE . ,.

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I herebh ce'r.t ify that the document attached hereto was served this

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' 507 tit M dafof; october ' ., "1983 by deposit in the U.S. mail, first:

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w' .9,cla. , , -sgposta6e Prepaid upon the following: ' ,

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.fJames P. Gleahoq, Esquire-F'; Mr..Glenn O.. Bright. .

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1. ~ ,", :, i ., c..ChMrman,, Atoud,c Safet'y .and- C 4 Atomic Saf9ty and>Li;cen, sing. 96ard .

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Licensing. Board, Panel JPanel- +

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513 m1=ause Drivev. . & .. - U.S. Nuclear Rettlatory,Comsdssion l'.t ,

Sily'er Spring,,tMaryland 2090,1e m:. Washington,'.'D.C.,.ll20$55 l' '.'. " '

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," _ . Dr. Jerry.'R. Kline ., Docketing and Servise.Sec, tion- i, .; ,

[ e fiAtomic Sahrt:y and.Licensink. -

. Office of the. Secretary .?

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so- . Board Panel

}k..,U.S'.)Nuc1 par Regulatory. Comad's'sion

, , U.S. Nuclear R,e Washingtoni, D.C'gulatpry C@ap .

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.'205S5.M,

.,, Washi'ngton, D.C. 20555' '; .;.

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Robert G~. Perlisi,'Ee ;p.s 3. , -

Office of the Executi@ve i.egal.(lirector Kenn~eth 'M. Chackes, Esquire .

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, Chackes and Hoare' , , U.S. Nuclear RegulaMiy;

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314 N. Broadway Washington, D.C. 20555 'psyion'. ' *:

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, la00 M.LStreet, Pittnan, Potts . N.W.&dTrowbr4dge. .' ll .4 L. ,' . r # ,

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@ Atomic Safety and Licensing 2 '

'.[",/yy.;J' Appeal Board *

,  ! U.S. Nuclear Regulatory Cour. mission -

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Washington; D.C. 20555 *

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