ML20202D171

Advises That Director of Regulation Has Requested Attached Memorandum of 720516,with Encl,Be Circulated for Discussion at Policy Session on 720518

ML20202D171
Person / Time
Issue date:	05/17/1972
From:	Mccool W NRC OFFICE OF THE SECRETARY (SECY)
To:
References
SECY-R-462, SECY-R-462-R, NUDOCS 9902010325
Download: ML20202D171 (9)

Text

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POLICY SESSION.lTEM t PROPOSED LETTER C65fPINOLLER GENERAL, TOCOMMnNTING THE HONORABLE

. STAATS, ON DRAFT ELMER OAJB k ftEPORT Fote by the Cecretary mamorandum of 16, MayThe 1972 Director of Regulation has requested hi s attached has provided the following digest:discuusion be circulated for at the Polic s ay, May 18, 1972 and GAO providing comments on th?The oDirector of Regulation i

j entitled the of User:,of Radj onctive Material", is Provided th Commission for information. e

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CD~MPM51IliR GENERAL,. STAATS, COMMiLNTING Offl GAJ fiEPORT f

d Note by the Occretary mcmorandum of16, M&yThe 1972 Director of Regulation has reque:>ted hi With enclosure , be circulatest s attached hca provided the following digest:discuusion s ay, for at the Polic May 18, 1972 and GAO providing comments on th?Theo Director entitled the of Reguistio

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4 ATOMIC ENERGY COMMISSION WASHINoTON,0.C. 20$43

} (f NAY I 6 IU2 Chairman Schlesinger

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Commissioner Ramey Commissioner Johnson Commissioner Larson Commissioner Doub I

GENERAL OF THE UNITED STATES, .

STAATS, COMPTROLLER PROPOSED L letter I propose to sendIinformation Staats, am enclosing a draft for the Com of a report, commenting on the General AccountingElmer Officto B. the Comptr Radioactive " Problems Material."Associated withegulation the R ofe's draft Users of As a result representatives,of meetings between members of nourGAO draft staff a d 1972. report as originally presented under the data number of We feel that th our principal and put the report concerns,ese changes have properly dealte ofwith March 7, include additional pertinent scope of the review.in This more perspective in relation to facts, the and comments attached. is reflected in my draft letter j

i- I would like to discuss date.

this with the Commission at an early i

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1 m L. Q Manning Muntzing Director of Regulation 1

Enclosures i

Proposed ler to Comptro116r Ceueral cc: Secretary (2)

General Manager (2)

General Counsel (2)

Comptroller k

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Contact:

L. D.

G. W. Roy Low - 7397

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{j DPAPf May 15, 1972

Honorable Elmer B. Staats t U. S. General Accounting Washiu6 ton, D. C.

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Dear ;ir. Staats:

This is to acknowledge receipt of a the dr ft report to the Conr u s of the United States on Problema Associ t d ae of Padioactive Materials," by the General Acwith the Regu counting Office (GAO).

In accordance with your staff's request

, we are setting forth our com-ments concerning the recocnendations contained i n the draft report for improving the effectiveness of AEC's regul atory program in certain areas with recpect to materials licensees .

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I We are in General a6reement with the draft report. reco=cendations set forth in the v

3 i Our concents concernind each recocnendati on are con-5 tained in the enclosure to this r. lette S As described therein, one of k

the recom=endations vt11 require furth er study.

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The primary objective of AEC's regulatory p able assurance that licencees use radioactivero6 ram io to pro materials subject to AEC jurisdiction in a safe Sanner and in compli quirements developed to achinve that objectiveance with AEC .

It has been our ex-perience that most lic$ncees use licensed c radioa ti {

ve caterials cubstan-tiallyincompliancewithAEC'srequirement s.

About 2/3 of AEC's in- \

spectionsdisclosenoYkolations,andinmostofth  !

e cases where noncom-E plianceisidentified,dNpropriatecorrectiveacti on is taken by licencees s,

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' in response to written notic es. Tb' I*q however, whose inspection hist' .. ave been a few licenseca, of violation have not beer .as have shown that vritten notices achieve and maintain a continuing prograsntirely ef 4

.\ o Yl El regulatory requirements. m of full compliance with all When noncompliance is found (in th the public or employees which e absence 'of an immediate threat to action) we have attempted to obtain co, of course, vould voke a licensee's authority to use radirrective action rather than many cases could deprive the public of oactive materials, which in however, that certain licensees must b an essential cervice.

We agree.

comply with regulatory rdquirements n the past.

than ie provided greater accomplish this throu6h a more rigorous We intend to all availabic enforcer,ent sanctions to theenforeccent pro 6ra:n this objective. extent necessary to achieve Ve believe that the recently acquired impose civil monetary pen $lties authority to vill provide a necessary incentive, which ve have already besu The draft report makes seve,r.

tionlevelsorpersonnelrkN[ational references to c- cituations in reguJatory limits. exposures which vere in excess of the EcEulalbl"/limitsforoccupationalradi ation expo-sures have been de;tberately c d't at levels levelswhicharelikelytoekOeobservbl a which are much lower than

' individualmembersofthepNicare e biolo61 cal dacase. Vnere t

are only one-tenth of the le+vei cet for radi tconcerned, the r a ion vorkers. {

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- Pay 15,1972 For these ..ons, custe- exposures in excess of reBulatory limits dic -

.n the draft report should not be viewed as necess

t .ae health of the exposed individual. arily affecting l

efforts to require that radiation exposures bWe shall, ho

.f} limits as practicable. e kept as far below the With regard to the use of radioisotope 6

s in nedicine, there are now an l estimated e1 ht million administrations opharmaceuticals ofper-radi formed annually for medical dia6nosis o r therapy. There have been 12 known cases of micadministrations of radioph armaceuticals, involving 20 individuals, during the eleven-year p report. eriod discusced in the draft

~4hile there have been no studies nowledge tothat our vculd k establish the precise number of actual misadminist rations, ve believe because of close contacts with the medical co=mu$2ity, that the number t

ol'misadministrations has not been . substantial We agree, however, that certain actions as reco::nended in th e draft report could be taken 6

which m1 ht reduce the probability of misadmi i t P.icadministration cases BEchi as those' discus n s rati sed in the draft report are attributable in lar6e part to hu:r.an error and it should 'ce recognisci that no reasonable amount of nre6ulation preclude suchca errors.

1 I vish to express our appr,ec<iation for the oppo t

> ,a r unity to review this document and to submit the fore o. 6oin6 co= ment

Sincerely, L. Panning Muntzing

Enclosure:

Director of Regulation i

Recconendations and Cocoentb

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( ENCLOSME _

- Develop and apply criteria describin6 the circumst ances under which d

licenses vill be suspended or revoked and civil assessed. penalties vill be The criteria should provide for enforcesent actions sur-4 ficiently severe to provide licensees with E.

'i with AEC's regulations. an incentive to cceply h\

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The develoIcent of such criteria y beenhas alread initiated.

As the draft report states, however

, the enforcement actions available ran6e frce written notices of specifi c violations or safety problems to license suspension or re o v cation, with civil penalties fallich accevhere in between y.[

Jud6:ent must t

j be exercised in deter =ining the specific ty pes of enforce =cnt to be taken in a given case.

Many factors must be considered in makin6 such jud6 :ents.

Ve believe that the critcria beinc developed vill provide guidance'for makin6 such jud6:ents and k fordeterminingtheadoEntsofcivilpenalti

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resultinareasonabledegreeofuniformityinthe enforcement, process;andtheyshoufdprovidelicenseeswitha Ercater in-centive to comply with kbC's regulations.

_RECOKMNfIO'

- Define in its medical licensis or re6ulations es that the activiti

.may be dele 6ated by physiciad and the activities not.

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ILMP2 May 15, 1972 Enclosure a

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• CO N NP Vork is under way to define in medical licenses a onsor regul ti the activitier that may be conducted by technicians i w .

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- Require that physicians detemine that technicians roperly have been p 1

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trained to perfom their duties and maintain records sh oving the basis l

for their deteminations.

COMMEITF While the licensee is responsible under existiC6 regul t a ory require-l ments for assuring that all activities authorized by the license are conducted in accordance with rc6ulations, and ve license con plan to incorporate into nuclear medicine licenses or the regula -

tions a specific require' ment that user physicianse identifi on the d

license detemine that technicians have been properly o trained t perfom their duties and that the licensee maintain records shovin6 the basis for such deteminations.

In addition, we are preparing a " Manual of Good Radiophamaceutical Practice," as an aid for

, technicians working in ddelear medicine laboratories .

_ RECOMMENDATION

-Establishaspecificrequir@mentthatsuppliersmustverifythata transfereeisauthorizedtor8ceivethequantityortype of material bein6 shipped and provide Guidahce as to acceptable r methods of ve ifi cation.

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Enclosure May 13 A

COMNP As the report points out, AEC regulati-currently contain pro-visions which prohibit shi; cent of radioactive cat erial to persons i

who are not licensed or otherwise receiveauthorized it. We to ,

plan to amend the regulations to state specifi

, cally that licensees must verify that persons to whom they ship radioacti ve material are authorized to receive it.

We vill also provide Guidance as to acceptable types of verification .

[ RECO'ENDATION

- Require medical licensees to report to AIX: all mi sadministrations of

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radioactive caterials to patients so that AEC can i nvest16 ate the occur-

[j rence and determine the cause and vhether adequat vas taken. e corrective action s

k COMCult .

This recoc:mendation is under study.

It is necessary to study n accepted medical ethics of the physician-patient y and the possible cons. relationship

[ equences of a government agency interjecting i

itself into this reldtionship.

,i. This matter vill be reviewed with our Advisory Committee on the Medical Uses opes.

of Isot RECO M NDATION i{

-Explorethefeasibilityohdevelopin6streamlineddo cumentation

\' techniques, includin6 fomdt$ for field not es, which might pemit the timespentdocumentinginspedionresultstob the time available for perfob.JLD6 additional nspections.

ie reduced, thus increasi t

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Enclosure Hay 15, 1972 COMGlNT

'l As is recognized in the draft report ,

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tion findin6s is necessary to enable AECdocumentation of ins j, the adequacy of inspections and tomana6ement u to assess m:.

pport the items of non-

$a compliance, and the &xtent of such documentatio n is a matter

[ .' which requires careftti balancing.

y the nunber of inspections performedIn the interest of increasica our documentGtion techniques with the objectivwe are curre unnecessary documentation. e of eliminatin6

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