ML20137Q566

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Package of Viewgraphs Re Proposed Rev to 10CFR35
ML20137Q566
Person / Time
Issue date: 09/06/1985
From:
NRC
To:
Shared Package
ML20136D915 List: ... further results
References
FRN-50FR30616, RULE-PR-35 AA73-1, NUDOCS 8509230052
Download: ML20137Q566 (34)
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Text

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  1. P02 Q~ j h /l0 6 i !Q

/q if t' TE PROPOSED EVISION OF

'N 10 CFR PART 35 i

,' PACKGRIN)

EGLATION I

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ItPACT DN IRC

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8509230052 850906 U" " " " ' ""

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INCOPLETE - EQUIRBMS AE IN i FIEGULATIQ6 LICENSECONDITIONS ORDERS EG GJIDES l

O INFLEXIBLE - MINOR PROGRAM CHANGES MJST E APPR00 BYNRC P

C011C BOOK 92 EADERSDIGEST 65 TIE MAGAZIE 52 O eR0e0seoeART3s 26 II6 CGE -6 OJRRENT PART 35 -56 2

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! CLEAN (P EGS j STREM.IE LICENSING t

SOURE OF PROPOSED EGS CURRE?R PART 35 RG 10,8 AND TEE filEG O

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STDLICCONDITIONS i

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4 SUGGESTEDLICENSINGSYSTEM i

NRC EVIEWS APPLICATIm M MIL EVIEW USER CREDEPEIALS OR PR00'11]ES M REVIEW #MS, EFT  ;

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O C& MISSION ESPONSE Ef00RSED SUGESTED EGulATORY TEXT DIECED EVIEW 0F USER CEDENTIALS DIECTED EVIEW 0F OPERATING PROCEDUES - !

STAFF IFIME ,

MINOR EVISICel E EGULATORY TEXT i

O EVIEW USER CEDENTIALS ON SUPP. A & B EVIEW PRCCEDUES SIMILAR 10 EC-313M P.2 REVIEW E0JIRET #0 FACILITY ~

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TIE PROPOSED EVISION OF 10 CFR PART 35 BACKGROUf0 EGULATION SYSTEM AT WORK ,

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WILIE T PROPOSED PART 35 SUBPART TOPIC A GENERAL INFORMATION B ADMINISTRATIVE REQUIREMENTS C TEC M ICAL REQUIREE NTS i

D iUPTAKE E II III IMAGING O F G

I DRUG TE.WY VI BRAOh7ERAPY H DIAGNOSTIC SEALED SOURCES I TELETERAPY J TRAINING K ENFORCEE NT i

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ALARA PROGPAM AT INSTITUTIONS ONLY T "' U MEllE SERVIE b MISADMINISTRATION-STATUS 0J0' SUPERVISION CLARIFIED C - TEONICAL EWIR9ENTS O

DOSE CALIBRATOR CALIBRATION SURVEY N'IER CALIBRATION SYRINGE #0 VI/L SHIELDS NO LABELS DAILY #0 WEKLY StBEYS PATIENT ELEASE AT 6MR/m OR 30Cr MOBILE SERVIE - LNIT DOSAGES ONLY STOPAGE OF VOLATILES #0 GASES DECAY-IN-STORAGE O

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ajiuE T PROPOSED PART 35 O

SUBPART TOPIC A GENERAL INFORMATION B ADMINISTRATIVE REQJIREMENTS C TEONICAL REQUIREENTS I

D I UPTAKE E II II IMAGING l F I DRUG TERAPY G VI BRACHYTERAPY H DIAGNOSTIC SEALED SOURCES  :

I TEIETERAPY ) l J TRAINING i i K ENFORCEE NT  ;  ;

h I  !

O D - lJPTAE (GEEPAl/D LL StBEf ETER i

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E - IMAGING (II/IID .

t O ti.no at suavey mItas i ,

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O F - DRUG TIBAPY (IVM) 4 SARlY PRECAIRIONS tl AND HL SUN ETERS 1

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I G - BRAD # THERAPY i

ELEASE OF PATIENTS INVENTORYLOG O SAFETY PEGUTIONS Ht. Sum mrER  ;

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H - DIAGNOSTIC SEALED SOURCES (EW) ,

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i LIXISCOPE

} BOE MIERAL ANALYZER  !

! LL OR HL ETER AVAILABLE i

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LL OR HL SURVEY KTER

. AAPM PETITION INTERLOCKS ADDED TO SPOT DECK

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WILIE T PROPOSED PART'35 l

SUDPART TOPIC A GENERAL INFORMATION l B ADMINISTRATIVE REQUIREM NTS C TECINICAL REQUIREN NTS l i

D iUPTAKE

\ E II III IMAGING F I DRUG TERAPY G V1 BRACHmERAPY H DIAGNOSTIC SEA 1ID SOURCES I TELETERAPY  ;

J TRAINING K ENFORCEENT MI

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O K - DFORCEENT INJUNCTION OR COURT 0@ER CIVIL PENALTY FIE OR IIPRISONNT ,

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TE PROPOSED REVISION OF 10 CFR PART 35 ,

O xxsoum EGJLATION SYSTEM AT WORK IPPACT ON EC I

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IN-VITRO I

RETAIN FORM NRC 1483 Q GRAEFATER 35.1I4c USERS IN 31.11 1

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Q TE EW SYSEM AT WORK APPLICATIONS

  1. DDENTS AND REEWALS INSPECTIONS i

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APPLICATIONS i

REVIEWAPPLICATIONASTODAYPERSRP O 1 s e, Emiest, AND FActun TElPHOE OR WRITEN DEFICIBLY LTR ISSUELICENSE l s  !

l LICENSE .

FOR AUTHORIZATIm NOT DAY-TO-DAY EWLATIm

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O LI&NSE m a emSS BPM AND QJANTITIES USERS:

JOE SMITH - RSO BILL JONES - QTCE J0m BLACK, le - SUBPARTS D, E ED BROWN, le - SUBPARTS D, E JILL TRtNBLE, DDS - LIXISCOPE ONLY MARY P%YER, MD - SUBPART I EXPIRATION DATE N0"IAW"ORSLC m e mS O . . .

1 E USERS - REVIEW T & E .

EW TYPE - AS H APPL PER SRP EW LDCATION - H PACKAGE H ETE - HQ WILL ISSE FRN l REEWALS - ItJtJtNCE PREVIOUS PACKAGE INSPECTICNS USE EGS, NOT APPLICATION CITATIONSIN1982  !

t 1 SE ERE BASED ON EGS O29 0F 1240) -

97% STAND ON DRAFT EGS G2010F 1240).  ;

/2 ;

Q TE PROPOSED EVISION OF 10CFRPART35 BACKGROUf0 EGRATION SYSTEM AT WORK INACT ON tRC i r

i IWALT ON NRC O ApeticAri0n Eview LICENSEINSEcTION PRC OPERATIONS s

APPLICATION EVIEW j APPL, WITH PROCEDIRES, SIMILAR TO OJRRENT l

STD REVIEW PLAN BASED ON EGS DE PAGE tICENSE j O No iN Acc0nannte W11N Oa S1a tic c0noiri0sS

! / 3 --

Q LI&NSE ItEECTION S#E ABILITY TO CI'IE CITE AGAINST EGS, NOT APPLICATION ,

SfW1ER ECORDS FILES ON SITE -

f0RE OPERATI0tB REVIEW, LESS ECORDS REVIEW NRCOPERATIONS ElICKER LICENSING #0 INS CTION  !

O INTER-EGIONAL LMIFORMITY i

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FEWER #UDENTS MINIt%L STAFF ETRAINItG a

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e" h // f/ay), ( fu?b M d f b)(C/

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/b/ f PROPOSED REVISION OF P RT 35

,' utU.m1Gn 5 MEDICAL USE OF-fBVPRODUCT-MATERIAL Industry Overview g gg gg.

Current Regulatory Policy g Why Change

/g The Proposal Impact Disputes O

I.

5 t

e

E LICENSEES NRC AgS Hospitals 2200 3700 go a Physicians 300 1100 -

yA//'

hhto$

TYPES OF USE Diagnostic pharmaceuticals bb gg/[g,7f/

.01-30 mci dosage; 10-15 miflion/yr / y h,t A (//*

Therapeutic pharmaceuticals10-200 mci dosage; 10,000/yr Brachytherapy sealed sources 70 mci implant for 3 days; 10,000/yr Cobalt teletherapy 5000 rads over 4 weeks; 200,000/yr DOSES Workers 90% get less than 0.5 rem /yr Eld Patients unt k U y 13CA. 0 ff% f L'} W '0 "

Diagnostic--1 rem whole body Therapeutic--5000 rads to tumor 1

.hawittb/1l 1 Ll!' -

CURRENT POLICY l

Licensing list materials; describe 152'o a-training and experience.

Apply /O-397g procedures (or promise to follow Regulatory Guide), l facility and equipment clarify, or strengthen Deficiency Letter the program itsts address, users, materials, "for medical Licensure use," "In accordance with application" Amendments submit amendment request, #

Major Changes describe change fmJ u.4/A/, # #"' '

/

submit amendment request, as, uns Minor Changes /

describe change /d40b M # ,

'M #

i reference application, Renewal describe changes Inspections watch workers, review cf/_/gg y, 7 , J.pv Inspection records, measure dose /

rates

,i ,;,-._,-

Legal Basis Application

  1. , Parts 20, /f/ J~r / .; / - A~

for Citations 19, 35, and 30 2

~ - .

, l 3 l O

% ' y N' y,:

~

I f M,. , ' ',/

PROBLEMS WITH CURRENT POLICY Requirements are scattered t);u) : & P!'..j ','/

/ / Regulations '

sni, x x&cll

/ / Regulatory Guides

  1. fcI / de[Mtb2d Licensa Conditions 7 ,>w, a x,. / n/-

'!/f u ,t!!)bb:0 0 Branch Po11cy jy , , y,(,

si f

'1kn'y 4 iy Unreadable

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Index*

Comic Book 92 Reader's Digest 65 Time Magazine 52 Proposed Part 35 26 IRS Code -6 Current Part 35 -56

  • Index algorithm and examples are from How to Write Plain English, by Rudolph Flesch Inflexible

)'(.!

v f" "Use "in accordance with" application ve#,

L 1800 amendments each year f '

j

> d :l. ;;o it ;L. ' - lU u ' '

l:' '

N.. . ; & l:. : s' m it a 3; d 3

WHY CHANGE Evolution has slowed New developments will be -

variations on current themes fs wl6 A2 IU f6 L - j;%' b u 'i ; ;~'

Increase agency efficiency / '

through standardization Free licensing staff for more important matters Allow licensees flexibility to select most cost-effective way to meet NRC safety objectives .

4

REQUIREMENTS IN THE PROPOSAL Current

  • Part 35 y pf,. g g Regulatory Guides -

r / l

&N / C//)AM/J Yk) - /0 ' 6T49 License Conditions / /

Branch Policy g[AL/ ,

Added NRC reviews teletherapy expert credentials Notify NRC if a physician leaves Licensee must issue a clear statement of authority to Radiation Safety Officer Teletherapy room safety check Training standards for uptake, dilution, and excretion users Changed Licensee can make minor program changes Operational definition of worker supervision Alternative patient release st'andard New " type of use" group--diagnostic sealed sources AAPM petition Alternative teletherapy calibration procedure 5

CURRENT POLICY PROPOSAL Licensing list materials; describe training and experience, Apply procedures (or promise to no change follow Regulatory Guide),

facility and equipment clarify, or strengthen Deficiency Letter no change the program lists address, users, materials, "for medical delete "In accordance Licensure use," "In accordance with with application" application" Amendments submit amendment request, M M/ My Major Changes n change [/

describe change submit amendment request, ,j Minor Changes In-house reviewt / / # M describe change

/br) h /00 C L ,b reference application, Renewal n change describe changes Inspections watch workers, review Inspection records, measure dose no change rates Legal Basis Application, Parts 20 Parts 35, 20,19, for Citations 19, 35, and 30 and 30 6

n?Ol Mhl MU 00' b, w, muscak a[k' MEN.

Applicant can reference a Regulatory Guide procedure or submit his own for NRC review 6M 6VP2 CA/

There are management pr :ad andtechnicalp[r;;educs Examples of each follow Elements that are underlined were included in the proposed regulation l

1 7 ,

,- . From R;gulatory Guide 10.8, Guida for the Preparation of Applications -

for Medical Programs. October 1980.

APPENDIX B gg g

f (A

'I

\

MEDICAL ISOTOPES COMMITTEE * . /

h}yp, 91/{&tdCV/b M &I($h hi Responsibility keeping personnel) are properly instructed as required by 619.12 of 10 CFR Part 19.

The committee is responsible for .

4. Review and approve all requests for use of radioactive @

1.

Ensuring that all individuals who work with orin theg material within the institution.

vicinity of radioactive material have sufficient trainins and experience to enable them to perform their duties 5. Prescribe special conditions that will be required dur-@

safely and in accordance with NRC regulations and ing a proposed use of radioactive material such as the conditions of the license. requirements for bioassays, physical examinations of users, and special monitoring procedures.

2. Ensuring that all use of radioactive material is con-g ducted in a safe m7ner and in accordance with NRC 6. Review the entire radiation safety prostam at least regulations and the conditions of the license. annually to determine that all activities are bein ducted safely and in accordance with NRC regulations Duties and the conditions of the license. The review shall include an examination of allrecords, reports from the The committee shan: radiation safety officer, results of NRC inspection, written safety procedures, and the adequacy of the
1. Be familiar with all pertinent NRC regulations, the institution's management control system.

terms of the license, and information submitted in sup h port of the request for thelicenseanditsamendments. 7. Recommend remedial action to correct any deficiencies @

identified in the radiation safety program.

2. Review the training and experience of all individuals @

who use radioactive material (including physicians. 8. Maintain written records of all committee meetings,@

technologists, physicists, and pharmacists) and deter- actions, recommendations, and decisions.

. (, mine that their qualifications are sufficient to enable them to perform their duties safely and in accordance 9. Ensure that the byproduct materfallicense is amended.h with NRC regulations and the conditions of thelicense, when necessary, prior to any changes in facilities, equipment, policies, procedures, and personnel, as

3. Establish a program to ensure that allindividoals whose@ specified in the license.

duties may require them to work in the vicinity of ,

radioactive material (e.g., nursing. security, and house- Meeting,Fregyency , , ,

  • The medical isotopes committee shall meet as often as neces h A rule is espected in test that would chanse the name.compoei-sary to conduct its business but not less than once in each tion.and functions of this committee. calendar quarter.

l The underlined requirements are included in the proposed revision at the section noted.

1. l35.31(b(2)(x) _.,
2. 9 35.31(a
3. l35.31(b(2)(xi)
4. 9 35.32(b)(2)
5. 8 35.32(b)(3)
6. l35.33
7. 9 35.32(b)(7)
8. S 35.33
9. S 35.32(a)(5 i 10. i 35.17 and i 35.36
11. $ 35.32(a)(2) l 10.8-19

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...

  • From Regulatory Guida 10.8, Guide for the Preparation of Applications

.- .-~ for Medical Programs. October 1980. ,

APPENDlX l AREA SURVEY PROCEDURES #M' ,

(i( W YW

l. All slution, preparation, and irsection areas will be @ 5. 'A permanent record will be kept of all survey results, Q surveyed dady with an aDpropriately low-ranse survey including negative results. The record wdl include:

meter and decontaminated if necessary.* g a. Location, date, and identification of equipment Q

2. 1.aboratory areas where only small quantities of radio- used, including the sertal number and pertinent active material are used (less than 200 pCl) will be counting efficiencies.

surveyed monthly,

b. Name of person conducting the survey. g
3. Waste storanc areas and all otherlaboratory areas will h be surveyed weekly, c. Drawing of area surveyed. identifying relevant @

features such as active storage areas, active waste

4. The weekly ahd monthly surveys will consist of: areas,etc.
d. Measured exposure rates, keyed to location on the @
a. drawing (point out rates that require corrective A measurement meter of radiation sufficiently sensitive to detect 0.1levels mR/hr. with a survey @

action).

h. A series of wipe tests to measure contamination c. Detected contamination levels, keyed to loca-Q tions on drawing.

levels. The method for performing wipe tests wilig be sufficiently sensitive to detect 200 dpm per 100 cm' for the contaminant involved. Wipes of f. Corrective action taken in the case of contaminah elution and preparation areas or other "high tion or excessive exposure rates, reduced con-background" areas will be removed to a low back- tamination levels or exposure rates after correc-ground area for measurement tive action, and any appropriate comments.

/O Area will be cleaned if the contaminationlevelexceeds perEl

  • 6.

' date hed.IntYcNion tYe survey results wm tw recorded.

e ever.

200 dpm/100 cm . gg ggg The underlined requirements are included in the proposed revision at the section noted.

1. 8 35.70 '

~ ' ~

2. l35.31
3. 9 35.70 -
4. 8 35.70 e 3 y / Die kC/ W '
7. 5 35.31(b)(2)(vi) / 7 cht JMi ja6s anMUW n ' a jn o

j..

g I o.8-39 9

. . ., A

,~

IMPACTS e

Safety and Effectiveness No increase or decrease in worker l y tatddhl-fMOdjIn.'dVCD1 '

Efficiency

,7,gu(p )g)gt, h NRC--reduces licensing staff time; savin could be used for increased inspection or other materials problems j gjgy Licensees--reduces queue and review time and fees; allows Radiation Safety Officer to do his job

^11CIAA7/W Cost NRC

$94.000 once to train staff; save $60,000 each year from decreased time 6/[>

/ Aavl p needed to prepare for inspections 3d//WW['

Licensees

$1.4 M/yr increase due to new requirements save $0.4 M/yr due to licensing change 10

)

,8

.L.

DISPUTES ,

/

. f MW " ' U' ' ' ' } } O ' 'Y-Lyct,)f f) "D Ltilfv [I O ff o Technical disputes among regulators Major--all resolved [ t? ;, / 6 6 ; h d .' @

/

Minor--RIII wants formal ALARA program for private practitioners Licensing and amendments RIII--review changes that decrease program effectiveness

/70 CM /

AgS- " Permitting licensees to make changes is an unwarranted relaxation of regulatory control'. . . b%

this puts too much control in licensees' hands. . ."

tJ,{afi />nalG) & /DilAd1 ? #/13tc1lCn /E)

M'/ / 'O #' #

Inspection AgS--Places too much burden on inspectors given time constraints and inspection frequency Physician training and experience credentials No major changes here; suggestion for an alternative standard is being handled separately N

Misadministration Industry wants reporting requirements taken out; Commissioners directed retention (SECY-82-388) 11

j

- r .

I i

$ bornmwso/6  :

4 b

SECY-84-485 PROPOSED REVISION OF 10 CFR PART 35 MEDICAL USE-0F BYPRODUCT MATERIAL 1

I f

1 LICENSEES g

Agreement NRC States Hospitals 2200 3700 Phy si ci a ns 300 1100 TYPES OF USE e Dia gnosti c Radiopha rma ceuti cal s

.01-30 mci dosage; 10-15 million ea ch yea r e Therapeutic Radiopha rmaceutical s10-200 mci dosage; 10,000 ea ch yea r e Brachytherapy Sealed Sources 70 mci impla nt for 3 days; 10,000 ea ch yea r e Cobalt Teletherapy 5000 rads over 4 weeks; 200,000 ea ch yea r

2 s

PROBLEMS'WITH CURRENT RULES AND GUIDANCE e Requi rements a re scattered

- Regulations Regulatory Guides License Conditions

- Bra nch Policy l

l L

e Unreadable due to many amendments e I n fl e xi bl e

' - Use "in a ccorda nce with application"

- Requires 1800 amendments each yea r

3 CURRENT METHOD PROPOSED METHOD Licensing Apply List materials; describe No Change training and experience, procedures (or promise to follow Regulatory Guide), fa cility a nd equipment De fi ci e ncy Cla rify or strengthen No Cha nge Letter the program Licensure Lists address, users, Del ete "In ma te rial s , "for medi cal a cco rda nce use," "In a ccorda nce with with a ppli cation" a ppl i ca ti o n" Amendments Maj o r ,

Submit amendment request, No Change Cha nge s describe change Minor Submit amendment request, In-House Review Changes describe change Replaces Agency Review I Renewal Reference application, No Change de' scribe cha nges l

l Inspections Inspection Watch workers, review No Change records, mea sure dose rates Legal Basis Appli cation, Pa rts 20, Pa rts 35, 20, fo r' Citations 19, 35, a nd 30 19, a nd 30 l

i

4 k SAMPLE MANAGEMENT PROCEDURE (

APPENDIX B*

MEDICAL ISOTOPES COMMITTEE

  • Responsibility keeping personne0 are properly instructed as required '

by i19.12 of to CFR Part 19.

The committee is responsible for t

4. Review and approve all requests for use of radioactive @ .

I, Ensuring that all individuals who work with or in theg material within the institution. ]

?

vicinity of radioactive material have sufficient trainins Prescribe special conditions that will be required dur-@  !

and experience to enable them to perform their duties 5.

safely and in accordance with NRC regulations and ing a proposed use of radioactive material such as the conditions of the license. requirements for bioamays, physical examinations of users, and special monitoring procedures,  !

2. Ensuring that all use of radioactive material is con-g ducted in a safe manner and in accordance with NRC 6. Review the entire radiation safety program at least regulations and the conditions of the license, annually to determine that all actmties are bei ducted safely and in accordance with NRC regulations l Duties and the conditions of the license. The review shall .

Include an examination of allrecords,reportsfrom the l The committee shall: radiation safety officer, results of NRC inspection, written safety procedures, and the adequacy of the 1.

institution's management control system.

Be familiar with all pertinent NRC regulations, the @

terms of the license, and information submitted in sup-port of the request for thelicenseanditsamendments. 7. Recommend remedial action to correct any deficienciet.@

identified in the radiation safety program.

2. Review the training and experience of allindividuals@

who use radioactive material (including physicians, 8. Maintain written records of all committee meetings h technologists, physicists, and pharmacists) and deter- actions, recommendations, and decisions, r9 mine that their qualifications are sufficient to enable them to perform their duties safely and in accordance 9. Ensure that the byproduct materiallicense is amended.h with NRC regulations and the conditions of thelicense, when necessary. prior to any changes in facilities, equipment, policies, procedures, and personnel, as

3. Establish a program to ensure that allindividuals whose@ specified in the license, duties may require them to work in the vicinity of ,

radioactive material (e.g., nursing, security.and house- Meeting,Fregyency , , ,

  • The medicalisotopes committee shall meet as often as neces h
  • Sary to conduct its business but not less than once in each A rule is es pected in lose that would chanse the name.compoei-tion, and functions of this comenittee.- Calendar Quarter.

The underlined requirements are included in the proposed revision l at the section noted.

l

1. l35.31(b(2)(x) _
2. B 35.31(a
3. l35.31b(2)(xi)
4. 9 35.32 b (2)
5. 8 35.32 b)(3)
6. 5 35.33
7. 8 35.32(b)(7)
8. i 35*.33
9. $35.32(a)(5)
10. i 35.17 and B 35.36

& 11. 8 35.32(a)(2)

  • From Regulatory Guide 10.8, Guide for the Preparation of Applications for Medical Programs. October 1980.

m

. . . 5 SAMPLE TECHNICAL PROCEDURE APPENDIX l* ~

AREA SURVEY PROCEDURES

1. All slution, preparation, and injection areas will be@ 5. A permanent record will be kept of all survey results.@

surveyed daily with an appropriately low ranse survey including negative results. Trae record win include-meter and decontaminated if necessary.' g a. Location, date,6 id identification of equipment @

Laboratory areas where only sanall quantities of radio- used, including the senal number and pertinent 2.

active material are used (less than 200 pCl) will be counting efficiencies.

surveyed monthly,

b. Name of person conducting the survey. g
3. Waste storase areas and all other laboratory areas will h be surveyed weekly, c. Drawins of area surveyed, identifying relevant @

features such as active storage areas, active waste The weekly ahd monthly surveys will consist of: areas, etc.

4.

d. Me asu red exposure rates. keyed to location on tne @

drawing (point out rates that require corrective a.

A measurement meter of radiation suffielently sensitive to detect 0.1levels mR/hr. with a surveyaction). @

A series of wipe tests to measure contamination e. Detected contamination):vels, keyed to loca-Q i b.

tions on drawing.

levels. The method for performing wipe tests wilig be sufficiently sensitive to detect 200 dom _per 100 cm' for the contaminant involved. Wipes of f. Corrective action takenin the case of contamin tien or excessive exposure rates, reduced con-elution and preparation areas or other **high tamination levels or exposure rates after correc-background" areas will be removed to a low back-tive action, and any appropriate comments.

ground area for measurement.

tYe pe prfoNrmbe

"* 6. Area d cleaned if the contaminationlevelenceeds done thN[e*n"ilIIcEl tver.

200 dprn/ loo cm2 .

survey results wiH tw ncorded The underlined requirements are included in the proposed revision at the section noted.

1. I 35.70 '

~

2. l35.31 ' -

9 35.70 3.

4. 35.70
5. 35.70 .
6. 35.70
7. 35.31 (2)(vi)

/

ew

  • Fi'om Regulatory Guide 10.8, Guide for the Preparation of Applications for Medical Programs. October 1980.

10.8-39

p ,y . . . . . . . . . . . . . ,

6 l

IMPACTS

~

e Sa fety and Effectiveness l No increase or decrease in worker or public dose I

e E f fi ci e ncy l

l NRC - Reduces licensing staf f time; savings could be used for increased inspection or other materials problems.

Licensees - Reduces queue and review time and fees; allows Radiation Sa fety Of ficer to do his job.

4 e

i 7

I i

ISSUES l I

e _ Technical disputes with the revision among regulators {

and licensees Maj or - None Minor - A few editorial changes a nd changes in equipment l requ i reme nt s .

t e Authorization to make minor changes  :

Agreement States " Permitting licensees to make changes is an unwa rra nted relaxation of regu-latory control .. ..Thi s puts too much control i n li censees ' ha nd s . . . .Ma ny procedures ca nnot be reviewed in the field because of time constraints

! a nd i nspe ctio n f requency. . . . "

i

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