ML20196A207

Forwards Notice of Intent to Conduct Negotiated Rulemaking, Preliminary Draft NRC Position Statement & NMSS Addl Text. Info Partially Withheld

ML20196A207
Person / Time
Issue date:	10/18/1988
From:	Mcelroy N NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Bernero R, Cunningham R, Thompson H NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20195D086	List: IA-88-529, Forwards Notice of Intent to Conduct Negotiated Rulemaking, Preliminary Draft NRC Position Statement & NMSS Addl Text. Info Partially Withheld ML20195D081 ML20196A167 ML20196A176 ML20196A194 ML20196A207
References
FOIA-88-529 NUDOCS 8812050287
Download: ML20196A207 (5)

Text

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• g UNITED STATES NUCLEAR REGULATORY COMMISSION j*,, *, /

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w AsaiNotoN, D. C. 20664 I.3 H //

CCI J 8198g NOTE FOR: Those on Attached List i

FROM:

Norman McElroy, Section Leader Pedical and Academic Section Medical and Concercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMS$

SUBJECT:

PRICE ANDERSON FCR "RA010 PHARMACEUTICAL LICENSEES" 4

The notice of intent to conduct a negotiated rulemaking was published October 14, 1988. A copy is enclosed.

l l

A prelimir.ary draf t of the NRC position statement was circulated to the I

team October 17 1988.

It is enclosed.

It has been marked to indicate l

where I will rec,or*ind insertion of additional text, or revision. A ma r k-t up reeting is schewuled for October 20, 1988.

If you have further corrents or information, please contact me.

J

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M.4.'1 L s ?

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Norman McElroy, Section Le er Medical and Academic Sect n i

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)I Itedical and Commercial l

l Use Safety Branch Division of Industrial and i

Medical Nuclear Saf ty, NMSS

[

Enclosures:

1.

53FR 40233 2.

Preliminary Draft NRC Position

[

Statement dtd. 10-18-88 3.

NMSS additional text l

4 cc:

F. X. Careron, OGC i

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j information in this record was deleted I

in accordance mth tht frf;1cm (f 10f2rm3000 t

Act, tumptbni M t

10lA._

ff. n. s g

y 4

8912050207 081129 PDR FOIA FELTON88-529 PDR

Attached List:

Hugh L. Thompson, Jr., NHS$

Robert M. Berr.ero, NMSS Richard E. Cunningham, NH55 Glen L. Sjoblom, NMS$

John W. N. Hickey, NM$$

Hichael Lamastra, NMS$

Patricia Yacca NMS$

John Austin, NMS$

Justin Long, NMSS Peter Loysen, NMSS Will Brown, NMSS Al Grella, NMSS

ENC 1.0SURE 1, Federal Resistee / Vol. 51 No,19e / Friday. O<t:ber 14. 1964 / Proposed Rules 30233 wes pajd basic pay by a fractoe whoes to conduct a variant of a negotiated with the peoMelona of the Act to numerstot le 52 and whose denominator rulemakjng to determine whether to conduct the "negodeled rulemaking* la le the number of weeh(between the enterinto todemru agreements with eccordance with the Administrstive date of appointment and the end of the persona Ucensed the Comm16e6on or Procedure Act 8 U S C. 551 and the applicable pay period.

by an Agnement State for the raldance prodded in AC11S (ci ne annual pay for sa employee t-smolecture, production, posseselon, et RecommendeHon 82-4,-Procedane for who legeDy and cot.currectly serves la use of radiotectopes or Negotiating Propowd Reestations." t more than one poeluos la the esa of the radjepaarmacevucela for medical CTIL Mi&2-4. Although the Act requires annual baats pay fLsed by law or purposes ("rsdiopharmaceutcal the Commluien to conduct a reguletton foe e och position.

licecates"). Withja thirty days after negottated rulemahtng" the proceeding

[nt Doc. es-m:e nled n.t>-set &as arel enactment (September 18,1948), the required by the Act deviefee in eome e,u.a e cose e NRC wu required to deet ste e impcrtant respects frorn the urval model convenor from a list ofin vidut!s for a negotated rulemaking re:ommended b the Admialstrouve Consequentjy, some of the ACUS

- - - - - - - - - - - - - ~

l NUCt.1AA RMUuTony Contenace of e United Steles (ACUS) r,commendadons mil not be relevant to COWWISS40gg to conduct the "ne tjaied ru!emahlriga the Price-Anderson rulemakin6 Within seg en mon e of enactment

[n riegotiated rulemakirig. the i

10 CFR Part 144 (Atarch 20,1Me) the centenot le to te renntatives of roons =ho may be l

provide recommendatjene on whether af ected by a rule, cludir4 the e acy, Indemedf1catloo of Ucensees That the Cominission should enter into conune se a group per a period time Wanuf acture, Produce, Pococes, et indemrury egnements with to try to reoch ecocensus on a draft UH Redlophermaceuticais er r diepharmaceuticallicensees If the proposed rufe. De age then une thia l

Radioteetopes fet Wedeel Purpooes cornenot recommeada that th*

censer.:se ae the beele or a posed Commissionindemntfy any of theee rule which h a luun x nouw Acancyt Nucleat Regulatory licensees, the convenoe must also g

sad comment.Tnds onauy, h asency Ccmmussion.

subnut to the Commission a draft stulf mthee the determinauon that a Ac11oes Nottee ofintent to conduct a preposed rule uttle forth the tems: and particular issue withta ita lurtsdiction negotiated rulemahta and schedule for condidons of such deminflcatictu If might be effecdvoly addressed through the negotiated rulem ing proceeding.

the cons enor recommends that the use of ne o'tated rulemaking A l

indemin be provided, the Commission convenotle en retained b the agency svuuanc, Section 19 of the Price-myit pub ish the recominondations as a to evaluate 'b fentbility e conducting Andenen Amendments Act of1M4 rotice of preposed rutemaking.

the negotiated rulernaktna, lacjuding the I

requires the NRC to conduct a no,lornmisston is hereby identificauon of the Hope ofluwee to negotiated rulemsking to determine announcir its intent to initiate the be addicisei the laterests that may be w hether to enter into indemnity negotiated emaking prxeedtng af!ected b the rufemaking. the partes areements mth penons licenst,d by the required by the Act. and te innting Nt wed nEnunt hu internta, Commission or by en Ag sement State partacipation in the proceedtn 8 * '

f th U

,,"g g[p,'t e for the manufactun. productiert persons who may to affected he g

f fa regotieted rulemaking proce+ dict al op er acs tica f e

Convenee this instance, the Price Anderson pspc ee ("redtopharmaceutical L;censen"). nis nouce utettlehes the On Au et 24,1984, the ACUS Amendments Act of1W nquttu de I

schedute and format for the netonated sabmitte e list of thirt two potentJal Commission to conduct the %egodeled rutemaking proceedtr,s.

cons enors to the MlC. fter evolusties Memaking; apart from any laittel l

c Afst De first session of the these candidates. the Commis 1on has decision by the Commimon on the

{3'," (ry or destrebtlity of the reces negotiated rufeeaking proceeding wdj designated Mr. lfoward S. Bellman se esme o 8'jny a be held on Noumber 14 and 15.1Ma,

'he con no og i rulemaking n

e nnirs att a m. and concluding at Q", EM Wtgo b

the Act establishes a schedule foe i

eat E*"

"I' Aconseest De ussien will be held ta of induetry,14 bot, and Humas comptetion of the ts!emahans.

Ref auona, has serud as the Ord.nanly, the objecthe of negotiated l

Room 2 F n of NRClleadquriers.One CortrrJssion's convenor and facilitatot rulemakir to to doelop a consensus on i

White Flint North,11554 Rocksule Pthe, Rockulle, hiargland, ne session wd! be for the negouated rulemaking on the a propcs rule. Consensus, in the i

l l

open to the pubut and wdl be h sh lnet tedjoecthe weste Ucenaica contest of ne otteted rulemaking is tu n scnbed, Support S) stem. He not only has usual! defin as no objection tving nyerience in the negotiated ru!emakte made any participant to the draft 904 mtuaa laeonesafices Contf Am procesa, but also kaowledge of the NR rWemaktng tut. Unless contensus le i

Francas X Cameron, Omco of the regulatory tramework and the federaj reached on the draft rulemaking te st, the Ceneral Counut. U.i Nuclear n Jatory proceu. In oddacon. he hu agency is free to decide whether to Re su! story Commis sion. Wa shington-su stannat arbitration and mediation roceed with a prmud rule, and what i

DC M555, Telephone: 301-4it:-167.3.

openence. Mr. Bellman can be reeched orm such a proposed rule should take.

l euensuswt Aav ineoauarsow at t19 Martta Luther nrs. Ir. Bou! sard, in the proceeding conterepleled by i

Mad!60n. Wixonsin 53m3, Telephone:

secnon it of the Act. however, the Bac1 pound g,33,.g,4g 3 pg, censenor is requi. red to submit a On Augut :a 1964, the President rnommendation on the indemnificetton I'd***

s'gned into law the Pnce-Anderson issue to the Commission regard!eis of Amendiments Act of 1944 Pub 1.100-Sectica 19 of the Price Anderson whether cor.sensus is ruched by the CA Sect 6co 19 of the Act requires the Amendinsata Act of1964 requiree the participants. Furthermore,if the Nuclear Rep.14 tory Canaission (NRC)

Corr.mtsaton, to the utent consistent consence rectamende that indemetty

4_0n4 Federal Resister / Vol. 53. Na 10 / Friday. Oct3er 14.1968 / Proposed Rules be provided for redaopharmaceutical arbitratiert in that the cor.venor le will attempt la develop a cortsensus of licensees. he is required to submit a required to make a binding the participanta in this proceeding as e proposed rule setting forth the terma and recommendattoa to the Commission basis for any proposed rule that he conditions of such indemnification regard!ess of whether consensus to might recommend to the Commission.

1:gether mth the proce& tee for reached, the Commission has not itself e ne spreuas smp doW be esecution of such indeemific4Uoo established a negotteting committee la uthonow i esoes na mutma to 6e es.bN agreements la this cites:estance, the order to evoid the ocjuelon of any only when necuury te pntect ecnrJennel Commjosion le then required to publish affected intnest. Rather. the convence data ce =bm in the twdawl of the the recommendations of the consener as will forro the netotiating committee paructrants.the hhelAcod of sch>cies e notice of propened n!emaking.

based on en esaluation of the detaued ce"868 *od t* s's'uhuntJr enhenad regardless of whether any conunsus posiuon statements required of any (ACUS Recommendatwe uk

• se reached amons the tarudpents.

person who desina to prtjcipate la the ne meetings la thle proceeding will Therefore, the Secton ll"eegotiated proc Hding.

W open to the pub 61c. Fueermore.

rulemaking" procudmg conte ms US Commlnion has also consulted memben of the public wid be ginn the elements of both cennnaus. building and mth the convenor on the ferrnet and cpprtunity to supress their epinions et

" W" E seenbn. a a ae aa* f* ae ~ne r-e*

to g "d",=l,e g n =,*,"llt;7, d

s format for this proceedmg in order to

• To er.sve that the e reste interuts the participanta in the proceedirg. and sin has bIc

"",",'d cnan e TV C 14h and n e o

considered the fo!!cwtrg in tre FWoral Resistes e noNa that it is meat Rcom,21:01. $tteet NW, recommendations from ACUS connye,mg duelor r4 a rde by Wa shington, DC XC)6 Recommendation 82-4 as apprope,a'e to resciauen and mdic4'e m the nono the this rulemaking=

ise,,es uttohed and tie perncipnts and 5dedule

• An egeny shodd seket and consult munes s!ned) msel,ed (ACUS gig e sessions heg e been odeduled foe

=nh a comunot at the earl 4st procheatJe P"emmedahon rk the negotjated N!emaking proceedine.

t;me steet the fees.baity ed the su of De Commission is issuing this notics 1 Nog ember 14.1L 1Mt.

nessuetd nJmahira lACVS to alnt potent:auy affuted mterests of 2 December L 6. 7.1M8.

Recommendaton 4L the proceeding. and to irmte g g ggg, As requind by the Pnce. Anderson raruciption by those affected interests.

g, Amendments Act of1H4 the A copy of the nottce wt!! be mai!ed to ggg Commission has selected a eenuno, NRC heensees. Agrument States. and g

g gg,,

from the list of individsals c ther orgentrations that the Commation and end at S co p m. each day, and atu ie ey be minuta in recomrrended by ACUt h held at de Commintoire i

. u ee e,es,..d re con,eeo...ee e.,

heuqu ne,s. one whue nmi Nenh.

no.s-, shoa des c.'e e sem-n ni,oa,tue m e.Roa,tus.

-s a.,,, ee,o.

is an.,.,e me cuene n,n.oni ee ner.o-. sed me, e no,.ho n,es,me f detemtart phman!y se Weeests that udt shed lder.tJy that eff cialin tRe Fedevel y,O and'dC8 90 N0%"Eb" N 8Md Il i

Re1 eee powe ( ACUS p ecorrsedsben si De8" 4

likely te si.ts'ent:aMy aftc<ed by a preposed 5tuan ^a"w".'oa ha d"ca"ad *ES' A'*nD'O"Ais by at0',"Wis';O'!/,'.Orlll2."

Counsel fer Rulemaking and Fuel C)cle, m ce==i w

^"ani ai me nn cinna and ao naarse ofihe i,s.e.to w s e e.. a a.,a e u e f e vertenr: oe.o* t ACUS detoled positjon statements requind foe a mer m e s.non :)

Office, of the General Couent to sm' pnicipanon in the proceeding ne time as 6e Comnunien e agensta and to allona for each prenntet on =tu be As noted abose. the Pnce Anderson repuunt u in de pmudes determined by the number of Artendments Act of1M4 enandated that 4

the Comtnission conduct a "negotiated e ti esy be that to prteder procudess.

part cipants At this meetmg the

" " 8 ' *

• U" d '8 ' ""' ' * * " W "

contenor *tu also address the m'emaktng" on the indemnification of

" A r"***'id4~1"3* ""t**W' gaidehnes for the proceeding The

• ra diop harm a c eutic al bcens ees -

'*[e*f,'(8,'l d b' e' el erin union schedaled for December i es 7.

Thnefore, the general seen of the g,

1WA will be desoted to responses to the rulemakmg has already been and tu agwy dew cceodu metsnirs e etablished. The Commission has the e.pnne sa och procipnte"(ACys position statereents The remotams consulted the congenoe on the scope of p eumaendenen og sessions wtil be desoted to attempung to deufcp a consensus on any preposed the is sues in the rslemakLng and how Beause of the arbitration espcts of N Gat may W duinW In ptentia!!y affected interesta should be this ru'emaking proceedmg the con.nnten wah ene latu nuions. Be identified. ne conunce doe to the CommJssion does not behn e that it is prtictrants should be pennd to short etetstory time schedule foe the apperma to nimbau any og ge engep m the drafnns of preposed N!es rWemalng. wiu not hoe the N'U'2D"4 M O' W"N8 that they would find acceptable.

cpportcuty to schett mdmdu Uy, the prtWption of affected mterests or to

• D e8H1ofth **8e ttAl5

• f A**ld t< n mu at a cenunews on ne gnpn+d gpag g g gemagg discuss the rulemakm3 iss,es with the C'IACUI h "**"d'"""k

1. 8 potentiauy afrected mterests The cens enor mtends to estabhsh the scope As noted sbose,in the proceeding The Act utabbahes a broad scen for c,f tesues based on the position contemplated by section 19 of the Act, the rec <eedmg ne issee of concern is statements required of py person who the censenor is required to submit a the mdemnificauen of"prsons hcensed wishes to participate in the rulerraking recommendation on the mdemrufication by the Commission or by an Agnement proc u d.ng issue to the Commission ngardins of State for the manufacture, prodacuen.

Because of this "nerae ated whether censensus is nached by Go possessien.or use of rahoisotopes or rulemaking" proceedirs Lns ch es prtic;pnts Howster, the congence rad.opharmaceubcals for medical

Tederal Register / Vol. $3. No,10 / Friday. Octobee 14.194g / Proposed Rules 402.33 purposes." Hcwever, a ny proceedin6. hu the nothority to require prouded for FYRC Forts Nos. 8 and tt ruommendeuco denloped la the the consobdason olpertidpeate wne to cortect danciencke and to proceeding, either by a conaenaus of ifie have eubstantietty the same Intmet thet inec porate the revisione decribed la participanta or by the convenor, may be may be afected by the proceeding. De thle dccenent.

conftned to any evbclase of the,e convence eleo hee the authority, beoed cart An original and two ceples of any I cenues, no Comadeolon has en his sealestion of whothw a peroom cornmente should be fLled no later thaa identitled the feuewing laternes as has submJtted the deto!,4 Informt5os October 21.1968. All comments should betag potensally aflected by this required La the wnttea poettion teference Dodet No. P.M47-17 000 and propodiae-atstemoet, to determine whe mil be identif!ed as "Swpplemental

• Pnvato practice p&ysicians partictMte la the proceedirts other than Commente on the Order No. 493

• C11nios ee a marnber of the pubbia

!mplementetion Conference."

• Hoepttels Deted et RedMe. Marytend th4 tan der

• Nuc. ear phersec$ee elOctober toeg Aoonasa Commenta and unta fot

• Mobde aucjeet owdjeal services For the Nuclear Regulatary Coewuseice.

Neud schwm prognme e ould be directed to Brooke Carter. Office of

• Teletherepy servicee lesivel & Chh.

• In vttro Nood teeting lebe y,en,cy We cmuses pinline and Producer Regulerios Tederet tangy Reftreet.}IF Room ato Commlulos 1

• Medicoltedjotectope manufacture o pyt p,.,r. ab.tmee r. led M-lMa tes a4 Las North Cap 4tol

• Radjopharmaceutical manufacturere

• • • 80'8 ?"H M

• Petient asecciarione 7010, Weshingtca OC 20428.

i l

• Agreement Ststee ton ryeressan nerosessatioes courtacyt

• Commerdsj insurere OE7 AMDl1NT OF ENEMGV Muam C. Andenon Office of npeline

• Other redual egencies sue.h as the and Producer Regulation. Federal Food and Drug Mu4trouos rgerel Enugy Reptatory Ennry Regdataey Commlutoa, sas

• Transprters of tedioisotope of ComrNoahn North Capttol Street h1 Washlagton, rediopharmaceuticale to be und for DC 2430 (302) 367-4e84.

medical purposas 18 CFM Parte 154,157,290,il4, Sol, gy,,, samortAav suponesArtons la

• Eantoamaatallatmet and 344 ediuos to poNishing the full tut of thle I

OII"El" UO8' Any person sebo deeltes to parucJpte (Docaet 66e Atte71F-000) d cament in the Federal Rosleeur the Commleoloa el6o provides et!Isteneted in the rufumaking procaedirLe mut Natural Gas Cate Co5+ction Systenus persons sa opportunJty to insped or notify the Secretary of the Commiselon.

ComrNulon Staff Response te and copy the contente d this docusesd L

U S, Nuctor R egulatcry Commisston-Notsce of Ava.'LabWty of Revised dunrig normal bustnue hours la Roosa Weihington. DC 20555, of it IntenI to Recond Formeto 1000 et tN Comalulosie Hudquitm.

participet'. Such nottl!c4Uoo mut be a:3 North Capttol Street SL postmerk ed no latet thatt Non ember 7,

!ss.ed Odober f. Isaa Washingtos DC 30428.

1 Sea, in ad&uort each nottf1 cation must aetvevt Federsj Eaugy Regulatory The Commisolos lesuance Poeting be accomparded by a deteded w1ntten Commiselon. DOL S stem (CD'5), and electronic budetsa 3

posiuon statement that addressee the acvices Staff tesponse to Ordt? No. 493 board smico, proddw access to the rollowing lsese*=

Implemenf rtion Conference sad notice testa of fortnel documents isseed by the

• The representative of the person of of evettabvary of resised reeerd formate Commleston. CIPS le as adable et ne crgantaation who m'3 participeto in the fut FTR C Form Nue. B.11.14 and 18-charge to the user and may be acteseed

" "8

[d l

ST

.h e a rure of the non's interest avwasaav; On September 12 and 13 that may be affected b th rulemahtng 196a. Correntutos staff conducted e

• m o nae a a n teni efth. ns u e u nf-en n io un,lemeni e e po usions ac,ceu CLPS. set your,comms,nication,

,*"m,

,, eo, s e pwblic health and sefety peed by the of Order Nos. 433 (53 Fil 15013 (Apr. ?.

o( concars 19681) and 493-A (53 FR 3rgy (Aug. to, h11 d p "mnj'{anty,8,dete bits rid 1 actmdtes a mlpntuun f.,

im ms e,as ennn aunee a-g~

't"u t;aatP,t,'fT'ge,dg,

e e

2o i

sua n.ue4,edewesebor.seesiro.

inhrmi s uoas ea,e ee.ta f.

e, corweedal sources clannesuoa prosaated dunna the

• h postion of the pertoa on confeteace. nie tesposas also test en dishtte in AScIl n!e format may On N hud im ee adiresue propoula rubmitted b whethu a propeed tWe en ia e _ a n oe..f,e u,*a,m.c.,e m i nnm,enie sies unfmeo C.r Cg,=,is, c,g' g,gr,3 tree, toe t.a D,,o n

m t.

,, a,d n o nsee e,aa, a o s m e. a.is oftusepe ns0. hue bee.

necessary, and a resesels fee the incorporated in the record formato. The

,,,,, m,y,, c.,n,,,,,,,,s,'

position teused farmete lot TTJLC Fons Noa,8.

WW8 DC M

• Any other facte pertinent to the it.14 and 18 are now asadable. A

t. Fuotnotes l

indemraficetton leese proposed format for tanff flung la also A copy of the notification and the evedable for comment purposee caly.

A A#nseht.tre wnttes pooittee. statestant should also Sta5 teque sta turcer cornment on the Staff agnet to nvise the footnote t e form orded to the cowsmoe. Mr.

reused record formate and the procedure fer the record formate la Howsid S Bellmaa til Martta Luther procedarw for evbmJrttna fihnge on an Ordu No. 43L m record formate mit King Jr. Bos'artard Mediaca. Wraccosa electrodc inedjua in adimon to be tegised to inchade a four charecter S m3.

cornmeote en specac tuues, staff footnote nfmnce numbu (footriose ID)

Fmoce with stadar interests ait requeste that reepadents sMrves the in each record ne foomote nfwence encouropd to conso'aiste that position need for as ed&tior.al confmnce after rumber f!ald mil be defined se a statemente and hir participeuen tn the roient record formata Ice rete. tens chmeta neld and may be left blank if proceedins. Da crurvesce ti accessary and cetttAcate fulnde are luwed F1melly, no footnote applies, t?ndw thle for the efrident condect d the st:5 La restains the Software progreene procedure, footnotes mil be rdmaced i