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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SECY-R 462-POLICY SESSION.lTEM

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PROPOSED LETTER TO THE HONORABLE ELMER B C65fPINOLLER GENERAL, COMMnNTING ON DRAFT OAJ t

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ftEPORT Fote by the Cecretary mamorandum of MayThe Director of Regulation has requested hi 16, 1972 has provided the following digest:discuusion at the Polic s attached be circulated for s ay, May 18, 1972 and GAO providing comments on th?The Director of Regulation o the entitled j

of User:,of Radj onctive Material", is Provided th Commission for information.

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GAJ fiEPORT f

Note by the Occretary d

mcmorandum of M&yThe Director of Regulation has reque:>ted hi 16, 1972 With enclosure s attached hca provided the following digest:discuusion at the Polic

, be circulatest for s ay, May 18, 1972 and GAO providing comments on th?The Director of Reguistio o the entitled

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ATOMIC ENERGY COMMISSION m,

WASHINoTON,0.C. 20$43

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(f NAY I 6 IU2 Chairman Schlesinger

l, Commissioner Ramey Commissioner Johnson Commissioner Larson Commissioner Doub I

GENERAL OF THE UNITED STATES, PROPOSED L STAATS, COMPTROLLER letter I propose to sendI am enclosing for the Com information a draft

Staats, commenting on the General Accounting Officto the Compt of a

report, Elmer B.

" Problems Associated with the R Radioactive Material."

e's draft egulation of Users of As a result representatives,of meetings between members of our staff a d report as originally presented under the data number of draft n

GAO 1972.

We feel that th our principal concerns,ese changes have properly dealte of March 7, the report include additional pertinent and put with scope of the review.in more perspective in relation to facts, This the and comments attached.

is reflected in my draft letter j

I would like to discuss i-date.

this with the Commission at i

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Q L. Manning Muntzing Director of Regulation 1

Enclosures Proposed ler to Comptro116r i

Ceueral cc:

Secretary (2)

General Manager (2)

General Counsel (2)

Comptroller k

Contact:

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D. Low - 7397 i

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W. Roy - 7347 2..

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{j DPAPf May 15, 1972 Honorable Elmer B. Staats U. S. General Accounting OfficeComptroller Genera es t

Washiu6 ton, D. C.

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Dear ;ir. Staats:

b-This is to acknowledge receipt of the dr ft a

the United States on Problema Associ t d report to the Conr u s of ae of Padioactive Materials," by the General Acwith the Regu In accordance with your staff's requestcounting Office (GAO).

, we are setting forth our com-ments concerning the recocnendations contained i improving the effectiveness of AEC's regul n the draft report for atory program in certain areas with recpect to materials licensees t

We are in General a6reement with the t'

I draft report.

reco=cendations set forth in the Our concents concernind each recocnendati v

3 tained in the enclosure to this lette on are con-i 5

k the recom=endations vt11 require furth As described therein, one of r.

S er study.

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The primary objective of AEC's regulatory p able assurance that licencees use radioactivero6 ram io to pro jurisdiction in a safe Sanner and in compli materials subject to AEC quirements developed to achinve that objectiveance with AEC It has been our ex-perience that most lic$ncees use licensed radioa ti

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c tiallyincompliancewithAEC'srequirement ve caterials cubstan-About 2/3 of AEC's in-s.

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spectionsdisclosenoYkolations,andinmostofth e cases where noncom-plianceisidentified,dNpropriatecorrectiveacti E

on is taken by licencees s,

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May 15, 1972 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

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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 than ie provided greater n the past.

accomplish this throu6h a more rigorous We intend to all availabic enforcer,ent sanctions to theenforeccent pro 6ra:n extent necessary to achieve this objective.

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 cituations i c-reguJatory limits.

exposures which vere in excess of the EcEulalbl"/limitsforoccupationalradi sures have been de;tberately d't at levels ation expo-c levelswhicharelikelytoekOeobservbl which are much lower than a

individualmembersofthepNicare e biolo61 cal dacase.

Vnere are only one-tenth of the le+vei cet for radi tconcerned, the r t

a ion vorkers.

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Pay 15,1972 For these

..ons, exposures in excess of reBulatory limits dic custe-

.n the draft report should not be viewed as necess

.ae health of the exposed individual.

arily affecting

t efforts to require that radiation exposures bWe shall, ho l

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limits as practicable.

e kept as far below the With regard to the use of radioisotope s in nedicine, there are now an estimated e1 ht million administrations of radi l

6 formed annually for medical dia6nosis o opharmaceuticals per-r therapy. There have been 12 known cases of micadministrations of radioph 20 individuals, during the eleven-year p armaceuticals, involving eriod discusced in the draft report.

~4hile there have been no studies to our k nowledge that vculd establish the precise number of actual misadminist because of close contacts with the medical rations, ve believe co=mu$2ity, that the number ol'misadministrations has not been substantial t

that certain actions as reco::nended in th We agree, however, e draft report could be taken which m1 ht reduce the probability of misadmi i t 6

P.icadministration cases BEch as those' discus n s rati sed in the draft report are attributable in lar6e part to hu:r.an error and it i

should 'ce recognisci that no reasonable amount of re6ulation ca n preclude such errors.

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

r unity to review this document and to submit the fore 6oin6 co= ment

,a o.

Sincerely, L. Panning Muntzing

Enclosure:

Director of Regulation Recconendations and Cocoentb i

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f-DMFT Pay 15,1972 ENCLOSME

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- Develop and apply criteria describin6 the circumst d

licenses vill be suspended or revoked and civil ances under which penalties vill be assessed.

The criteria should provide for enforcesent ficiently severe to provide licensees with actions sur-E. i with AEC's regulations.

an incentive to cceply 4

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The develoIcent of such criteria has alread y been 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 Jud :ent must be exercised in deter =ining the specific ty 6

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t j pes of enforce =cnt to be taken in a given case.

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

6 Ve believe that the critcria beinc developed vill provide guidance'for makin6 such jud :ents and 6

fordeterminingtheadoEntsofcivilpenalti k

es; they should k

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

_RECOKMNfIO'

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

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

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ILMP2 May 15, 1972 Enclosure a

l1 CO N NP Vork is under way to define in medical licenses or regul ti a ons the activitier that may be conducted by technicians i

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- Require that physicians detemine that technicians have been p l

roperly trained to perfom their duties and maintain records sh

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oving the basis 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 license con

, ve plan to incorporate into nuclear medicine licenses or the regula tions a specific require' ment that user physicians identifi d e on the license detemine that technicians have been properly trained t o

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 methods of ve ifi r

cation.

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LPAFT 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 who are not licensed or otherwise authorized to i

receive it.

We 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

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RECO'ENDATION

- Require medical licensees to report to AIX: all mi sadministrations of radioactive caterials to patients so that AEC can i

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nvest1 ate the occur-

[j rence and determine the cause and vhether adequat 6

vas taken.

e corrective action s

k COMCult This recoc:mendation is under study.

It is necessary to study accepted medical ethics of the physician-patient n

and the possible cons.

relationship y

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equences of a government agency interjecting itself into this reldtionship.

i This matter vill be reviewed with

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our Advisory Committee on the Medical Uses of Isot opes.

RECO M NDATION i {

-Explorethefeasibilityohdevelopin6streamlineddo cumentation

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techniques, includin6 fomdt$ for field not es, which might pemit the timespentdocumentinginspedionresultstob the time available for perfob.JLD6 additional ie reduced, thus increasi nspections.

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Enclosure Hay 15, 1972 COMGlNT As is recognized in the draft report

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tion findin6s is necessary to enable AECdocumentation of ins i

the adequacy of inspections and to u mana6ement to assess j,

pport the items of non-compliance, and the &xtent of such documentatio m:.$

which requires careftti balancing.

n is a matter a

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the nunber of inspections performedIn the interest of increasica y

our documentGtion techniques with the objectivwe are curre unnecessary documentation.

e of eliminatin6

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