. _ _ _

"

On OnFORM NRC 313 t u.s Noc%,JR REGULATORY COMMISSION U APPLICATION FOH:-

n 191 '*

10 C F R 3 0 (Check and/or compiere;rs approprm:v)

See supplemental sheetAPPLICATION FOR BYPHODUCT MATERIAL LICENSE

INDUSTRIAL a. NEV/ LICENSE

& c at:3.na ,.+ uwwn iur detaoy.u ayysongsi 30

L i C E N S E v4 G5' CITC u ; w u spc car ,ni are % f , h v uore svm the Da v:n of Fuel Cs rie aM ristemi SMerv.

Ona e af M: w A*stera! SsN tv .pna Wesurk U S %! ear Re:u'atory Com.n ssan,Wash ng?co. DC :ObM ca 3,mcar ons ruv he f. st m retron at ?h" Cnnss".'n s of ta e at y c n g NE,, At 97

1717 H S tw" M W nr en. ,') C. or 19 'S E nrm r ent e . Ser S"ang A'ary land. p s y w ggyggy_gg$99_gy

5 APPLICANT'S NhMi //rar:turen, f,rm. persari, erc>3. NAME OF PERSON TO BE CONTACTED REGARCING 1HISAlfred I. duPont Institute of the APPLICATION

Nemours Foundation Charles Hartzell, Ph.D.TE LE PHOrdE NUMBE R. ARE A CoM - N U V 0 f R 1: A TE NSinN T E LE PHONE NUMB E R - ANF A CODE - NUMBE R E XT ENSION302-571-10C0 302-571-1000. Ext. 302

4. APPLIC ANT'S M AILING ADDES5/r*clu fe Op Cam5 STHEET ADDHE$5 WHERE LICENSED MATERIAL WILL BE USED(In&de Z,p Correl

Rockland Road Laboratories of Research DivisionWilmington, DE 19599 A.I. duPont Institute

Rockland RoadWMm_Lnnton. DE 19899

HF MORE SPACE IS NEEDED FOR ANY ITEM, USE ADDITIONAt. PROPERLY KEYED PAGES.)

|% INDIVIDUAL (S) WHO WILL USE OR DlHECTLY SUPERVISE THE USE OF LICENSED MATEnlALISee it n s ?G a,d 17 tw rea wed tr ,n.ng se:J esum sem e c! emh nbyn| vat named belovv)a

'FUttNAME TITLEIndividuals approved by the Radiation

L SaleCLColm;ilteeCharles Hartzell, Ph.D. Chairmanu

,

--

,' See supplemental sheet

1 R A DfA TICN PRO TECTDON OFflCE R iA nuh a resume of person s tra. n > q onn esprie: ice as authned so items

| 16 and 17 ar'd creser obe his restwmb,hties under item 15Charles liartzell, Ph.D. I See supplemental sheet

I_ _ _

8. LICENSE _D MATEHlAL_

. - - - - _ _ _ . _ _ _ . _ -.

_. _

l s AND AN D,OH AND MILLICUHlES AND/Oh SEALEDN M ASS NUMM R PHYSICAL FORM MODEL NUMULR SDURCES AND MAXtMUM AC11E /// S+'*/a/ Sourc e) VITY PER SOORCE WHICH WILL

BF PO$SESSEO AT ANY ONE TIMENO. A 8 C D"'

_

-- Atomic #'s 1 - 83 Any (NA)* *

---- - _ _ . -

_ .. . - ,

12' R-3AnY__ _ . (NA) _ 13 &_

C-14 'Any (UA) 1 Curicg,

_ . _ _

total POSSESSION LD!IT OF ALL !!ATERIyS NOT TO EXCEED 5 CUFu,

IESI

DESCRIBE USE OF LICENSED MATERIALE

,10 All 'ay-Moduct material will be used for in vitro and in vivo non-hutaan research_

m gnd ste*/elopment in the laboratoriro of the Research Division of A. I. duPont In-o, otitute of the Nemanra Foundation at the address given above in Itero 4 and 5.

$rmamos ,g g "EM-RECORD-CDM" **

-

_ _- __ . . ..___

~

9. STORAGE OF SE ALED SOURCES 1 ja

I CONTAINER AND/OR DEVICC IN WHICH F ACH SEALEO N AME OF FAANUTACTURER MODEL NUMBERN SOURCE WILL DE STORYD OR USED.ENO. A. D. C.

I",No sealed sources Currently on hand

m_ - _ _ _ _ _ _

(3)_

-- =

lo

10. R ADIATION DETECTION INSTRUMENTSTYPC M ANUF ACTURER'S MODEL NUMBER R AOl A TION bENSITIVIT Y

( OF NAMC NUMDER AVAILABLE DETECTED RANGEN INLT f3 UME N T lsipha. beta, (m ulb roe'n tgen s/ hour

n'a _ o.nmms. neutron / or counts |m:nute)A B C D E F

Liiuidine SL- 30 1 94 y 0 -_2 x_106Scintillation Intertechniqu cpm

CM Survey 493-5 0 - 50 nR/hrblieter_ & Probe * Mictorcen 489-35* 1 u, 8, y 3 - 300,000 cpm

_

Nuclear Assoc., 0 - 50 mR/hrGM Survey '

gMeter __l01_Corpa PSM dOO 1 _a__ y _

3 - 109h000/ Cpm--

(4) |_

11. CALIBR ATION OF INSTRUMENTS t ISTED IN ITEM 10EYi. CAllBH A TE D BY SEf1VICE CO8,tPANY Ch. CAllDR A TED DY APPLICANT

A tisch a s par ere st ret dryrobing method, frequency enct starbrdteN AVL, ADDRESS. AND FnEOULNCYRadiatitin Lna;;nent Corp, , Philadelphia, P a 3 " 'd ' ' ' " * '' " """' """' * " "-License #37-13129-01

Every six (6) nonths__ _ - - -

12. PERSONNEL MONITORING DEVICESTYPE SUPPLIL H E)(CH ANGE FREQUENCY

(Cher k and o' w~p ere as avi' rap'ar" i IS'IvM C CutTT ony) gA tl_ _ .

A stucAccc Toledyne Inc. O Mc4THLYWestwood, N..I.

C m 1HE RYGLW Ntsef av t C OUA ATEHLYOOsiME TE n m O/

O C3! O T HE H IS;*c 9,1 _ U O T H E n ISt>#aty I:

__ -

-., , -

13. F ACll.lTIES AND EOUIPMENT (Chd v.ere approprote and atta-h annototal sketch (eg and descriptionN.$a L ABOn A TOR Y F ACILITIE S PL AN T F ACil lTIF S F UYL HOQUS Ilv. awe /str,r,on. </ anyl, E T C

( k,| b STOR Ar,F F ACIL ITiE S CONT AltF HS, SPLCI AL SittE L Ol4G /%*d and 'or temporary). E TC

Mi Hf MOf f H ANDLING TOOLS OH f GuiPVENT. E TCYa orSPin ATOH / PHO TEL TlVE COUlWE NT. E Tc See DuPPlemental r.heets

14. WASTE DISPOSAL4 NAME OF LOMYE HCI A L M. Sit OfSPOS AL SF Hvict rMPLOYf D

Teledyne Inc., Westwood N.J.t _

O ir COMMERCI AL WA",TE D!SPOSAL SF HVir.[ as OO I E MPL OYf O, SURVII A DE TAILE O DF SCRIP TION Of ME T HOUS WHICH V.lLLBE USED FOR DISPOSINr> OF H ADIOACTIVE WASTES ANL) LSTIMA f f S Of THE T VPE AND AMOUNT OF ACTIVITY INVOI VED IFTHE APPLICATION 83 FOH SE ALE D SOUHCE S AND DEVICF S AND THE Y WILL fil HL TUHB.E D TO THf MANUf / CTt|HtH,SO UTATE

e, .

F or *A NRC 31J l { 1 NI

.

.

-.

" '

On . . OnINFORMAT' ION REQUIRED FOR ITEMS 15,10 AND W+ . e

Describe in detail the information required for items 15,16 and 17. Begin each item on a,

separate page and key to the application as follows:

15. R ADIATION PROTECTION PROGRAM. Desenbe th( radiation protection prograrn as appropriate forthe material to be used including the duties ?>nd responsibilities of the Radiation Protection Officer,control measures, bioassay procedures (,f needafl, day-to day general safety instruction to be followed,etc. If the application is for sealed source's also submit feak testing procedures, or if lesk testing will beperfnrmed using a leak test kit, specify manufacturer and model nurnber of the leak test kit.

16. FORMAL TR AINING IN RADI ATION SAFETY. Attach a resume for each individual named initems 6 and 7. Describe individual's format training in the following areas where applicable. Includethe itame of person or institution providirig the training, duration of training, when training wasrece;ved, etc.

a. Principles and practices of radiation protection.

b. Radioactivity measurement standardization and monitoringtechniques and instruments.

c. 41athematics and calculations basic to the use and measurement ofradio 3Clivity .

d. Biological eff ects of radiation.

17. EXPERIENCE. Attach a resume for each individual named in items 6 and 7. Describe individual'swork experience with radsation, including where experience was obtained. Work experience or on-the-job training should be commensurate with the propowd use, include list of radioisotopes andmaximum activity of each used.

See supplcraental sheets

._

18. CERTIFICATE(Th os tern must be comph ted by appiscont)

The aopbcant and any olforoat esecuting this certof.cate on behalf of the appbcant named on item 2,certify that thos apolocat,on as prepved on conformity with Totte 10, Code of Federal Regulatoorus,Part 30, and that an onformaroon contarned hereon, ontludinos any supplements attached hereto, os trueand ccrrecr in the trest of our knowkdye and behef.

WARNING.-t8 U.S C., Section 1001) Act est Jirne 25,1948; 62 Stat. 749; makes et a crimmal offenk to rnake a willfully f also statement orreprese+19stson to say Itepartrnent or agency of the United States as to any matter vwithin its jurisdiction.

IEENSE FEE REQUIRED CFRTlf Yi/h OFFICI AL /6pararrel, (tj

(See Section 170.31.10 CFR 1/0) / (a j ', ; 1m

$150 ' ''^*'''v"'"'"""'' '

G._ Dean fiacEwen J 1d TITLE

fil LICENSE FEE CATEGORY- K liedical Director, A. I. duPont Institute

'ra ucENst: FLE rNCLO3EO. 5150 July 6, 1979

eow ndiTiT7 im

,- . . . .-. - . ,

O (~),

Qf e

SUPPLEMENTAL SHEETS

1. The laboratories of the A. I. duPont Institute Research Division are currentlyoperating under specific license 07-16199-01, but now wish to apply for a" type A' license of broad scope for in vitro and in vivo non-human use ofby-product material for research and development.

6. The members of the Radiation Safety Committee are:

Charles R. Hartzell, Ph.D., Chairman and Radiation Safety OfficerT. Timothy Myoda, Ph.D., Chief of MicrobiologyPatricia F. Borns. H.D. , Director of RadiologyMarj orie Lou, Ph.D. , Research AssociateArvin H. Northup, M.S., Director of Materials Management

Jenny M. Johansen, M.S. , Consultant (Safety Coordinator and Radiation| Safety Officer at University of Delaware)

See Item 16 and 17 for training and experience of Radiation Safety Committee.|

| 7. Radiation Safety Officer.

I a. Dr. Charles R. Hartzell will be serving as Radiation Safety Of ficer and| Chairman of the Radiation Safety Committee for the purposes of this! renewal application.|

b. The Research Division has requested and is awaiting approval of a position

| for a full-time Radiation Safety Officer. The person to be sought will be

! required to have a B.S. or M.S. in Radiological Health Physics with appro-priate experience or a B.S. or M.S. in science or engineering with two-to-four years experience in health physics.

c. Jenny M. Johansen, M.S., Safety Coordinator / Radiation Safety Officer,University of Delaware, will be serving as our consultant in radiation safetyon a one-time per month basis. She will provide periodic review of the

| safety program including review of the records required to be maintained1 and also attending meetings of the Radiation Safety Committee.

d. See Items 16 and 17 for training and experience and the attached RadiationSafety Manual, pages 2 and 3 for Item 15.

| 13. Sketches of laboratory facilities, plant facilities or fume hoods are not'~~~submitted with this application.

iThe Radiation Safety Committee has the responsibility to approve the use of'

radionucludes in any given laboratory. With regard to the general designspecifications, the Committee will consider the amount of laboratory space,

,

i sinks, work-bench surfaces, ventilation, availability of a fume hood acceptablefor use with radioactive materials, wall surfaces and floor covering.

Ideally, work-bench surfaces should be stainless steel, but other non-absorbentI surfaces would be acceptable in most instances. The use of disposable plastic-

| backed absorbent paper will be required on the work surfaces in all radionuclide| laboratories. Non-recirculated air should be provided to these laboratories,

although the committee may make exceptions in the event that very low levelsof activity are proposed. The flow rate of hoods in these inboratories

00524_ _ _ _ . ___ ____- _ _ _ ______ _ _ _ - ___ _ _ _ _ _ _ _ _ - _ _ _ _ _ _. _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ . __.

, o

be /

-2-

will be,100 linear feet per minute or greater. Iloods should be single-ducted 7and filtered with exhaust ducts directly to the outside roof of the building. ,The walls should be smooth and non-porous and easily removable in the event aspill cannot be completely removed by decontamination procedures.

Unless specifically exempted by the Committee or the Radiation Safety Officer,each laboratory shall have on hand or readily available in operating conditiona properly calibrated survey instrument or monitoring instrument appropriateto the type and level of ionizing radiation used.

The Committee will determine if other special equipment (remote handlingdevices, special shielding, containers, and respiratory protective equipment)is necessary based on the anticipated needs of each individual laboratory;the energy, radiation emitted, and amount of radioactive materials used; andthe type of operation for which the radioactive materials are contemplated.

It is recommended that as much work as possible be carried out in the hoods.Where not practical, the design of the experiment and the equipment shouldbe such as to ensure the trapping of vapors, gases, or dusts. Other special

,

restrictive conditions due to the experiment may be imposed by the Committee.

15. Radiation Safety Program

In addition to weekly contamination checks performed by authorized users andpermit supervisors, A. I. duPont Institute has contracted Radiation ManagementCorporation (R.M.C.) to carry out quarterly radiation surveys and contamination Jchecks. In addition, quarterly bioassays of urine, if required by the Radiation '?

'

Safety Committee will be carried out by them. A.I. duPont currently has nosealed sources containing radioactive materials. Should they be purchsed, leaktesting would also be provided for through R.M.C.

The Radiation Safety Manual which documents our program is attached.

M.18

..

,

/'h N

bh i e

-3-

16-17. Formal Training in Radiation Safety and Experience of Members of theRadiation Safety Committee

A. Training and Experience of Chairman and Radiation Safety Officer

Charles R. Hartzell, Ph.D.

Type of Training Duration Where Trained Training Status

16 a, b, c, d 3 years Indiana University Formal courseBloomington, Indiana work and on-the

job training,

Experience with Radiation (Item 17)

Type ofIsotope Maximum Amounts Experience Gained Duration Use

H-3 1 millicurie Indiana University 3 years ResearchBloomington, Indiana

Pennsylvania State Univ." "University Park, PA 7

" "C-14 1 millicurie Indiana University 3" "Penna. State Univ. 7

" "University of Wisconsin 3Madison, Wisconsin

" "P-32 2 millicuries Penna. State Univ. 7" "University of Wisconsin 3

B. T. Timothy Myoda, Ph.D.Current Radiation Protection Of ficer, License #07-16199-01

(Expiring August 31,1979)_

Type of Training Duration Where Trained Training Status

16 a, b, c, d 3 years Iowa State University Formal courseAEC Ames, Iowa work and on-the

job training

||

l,

,

(%

e < v

-4-

E perience with Radiation (Item 17)3

Type ofIsotope Maximum Amounts Experienced Cained Duration Use

Ce-144 Pr-144 Microcurie and Iowa State Univ. & 4 months Formal courseP-32 C-14 Millicurie AEC, Ames, Iowa WorkFe-55 Sr-90 AmountsY-90 Co-60

C-14 100 millicuries Iowa State Univ. 3 years Research" " "P-32 50 Western Reserve Univ. 3"H-3 20 Institute of Micro-" " "I-125 2.5 bial Chemistry 2

" "A. I. duPont Inst. 5

C. Patricia F. Borns, M.D.

Dr. Borns' formal training has covered Items 16 a, b, c, and d throughouther training as a Radiologist. She has had experience (Item 17) withradioisotopes in her residency. Dr. Born has been a Radiologist since1955. Her curriculum vitae which includes 23 publications is attached asAppendix A.

D. Marj o rie F. Lou , Ph.D.

Type of Training Duration Where Trained Training Status

16 a, b, c, d 6 months V.P.I., Virginia Formal course

Experience with Radiation (Item 17) Type ofIsotopes Maximum Amounts Experienced Gained Duration Use

C-14 Microcurie to V.P. I. , Virginia 2 years ResearchLess than 2 Boston Univ., Mass. 3 " "

Millicuries Harvard Univ., Mass. lb " "

A. I. duPont Inst. 1 year "

BostbnUniv., Mass. 3 years"P-32 "

Dr. Lou's curriculum vitae is attached as Appendix B.

uOrt 01. RECORD 00?Y"-

, ._

hV e o

-5-

E. Arvin H. Northup, M.S.

Mr. Northup is the representative of the Administration on the Committee.His education and training are listed below.

B.S. Louisiana State University, Baton Rouge, Louisiana, June 1940Engineering and Political Science

M.S. Tulane University, New Orleans, Louisiana, June 1941Aeronautical Engineering

Lt. Col. , Rated Command Pilot, U.S. Air Force (ReserveActive Duty 1941 - 1956

Aerospace Apollo Program, 1962 - 1974Program Manager / Contract Administrator

Secret Clearance - Armed Services

"Q" Clearance - Atomic Energy Commission

Director Research Services, Alfred I. duPont InstituteApril, 1974 - July, 1974

Director Materials Management, Alfred I. duPont InstituteJuly, 1974 - Present

F. Jenny M. Johansen, M.S. (Radiation Safety Officer License #07-01579-19)

Education & Training

1965 B.A. Biology / Chemistry, Concordia College, Moorhead, Minnesota1969 M.S. Radiological Health Physics, North Dakota State University

Fargo, North Dakota1969-1970 Research Assistant, Radiation Safety Officer, Virology and

Tissue Culture Laboratory, Tufts Medical School, BrocktonV.A. Hospital, Brockton, Massachusetts

1970-1971 Health Physicist / Chemist, Radiatio,n Safety Officer, NuclearMedicine, Peter Bent Brigham Hospital, Boston, Massachusetts

1971-1974 Health Physicist, Assistant Radiation Safety Officer, JointCenter Radiation Therapy, Boston, Massachusetts

June,1974 to January,1976 - Radiation Safety Officer, University ofDelaware, Newark, Delaware

January, 1976 to present - Safety Coordinator / Radiation Safety Officer,University of Delaware, Newark, Delaware

September, 1975 to present - Instructor in College of Graduate Studies,U' iversity of Delaware, Newark, Delawaren

116u

, _ _

O O, ~

-6-

t

Experience with Radiation (Item 17)Type of

Isotope Maximum Amounts Experience Cained Duration Use

H-3 25 mil 11 curies M.S. degree work Various ResearchC-14 20 and work related times with- Clinical" '

P-32 100 in the last' Therapeutic"

Co-60 Teletherapy unit 14 years Medical

Y-87 10 mil 11 curies ,

"Sr-87m 10Y-90 10 nicrocuries

'"Sr-90 . 1-0

Mo-99 500 mil 11 curies"Tc-99m 750"Sn-113 250"In-113m 250"I-125 400"I-131 150 ,

"Xe-133 100Cs-137 87 CuriesIr-192 1 CurieAu-198 100 millicuries

"Hg-197 20"Rn-222 200

Ra-226 1.2 CuriesAm-241 100 mil 11 curiesPuBe 6 Curies

,

4

#

-l..

, _ _ . . _ .. _ .. . - , _ _.-___ _ .__ . - _

'Appendix A

C_UNRICULUM' VITAE, ,

NAME: Patricia FlintiBorns, M.D. .

I HOME ADDRESS: 3411 Warden' Drive- Philadelphia, Pennsylvania 19129

OFFICE ADDRESS: A.I. duPont Institute of the Nemours '

Foundation, Box 269, Wilmington, DE 19899

SOCIAL SECURITY NUMBER: 572-20-4890

DATE OF BIRTH: January 8, 1922+

'

PLACE OF BIRTH: Barstow, California

MARITAL STATUS: Married 1942 - W.J. Borns ,

Children - David born.1950j - Jane born 1955

EDUCATION: 1938-1942 - Purdue. University *

- B.Sc. with Distinction,

*

1944-1948.- Women's Medical College of.Peansylvania

POSTGRADUATE TRAINING: 1948-1950 - Intern-Philadelphia General:Hospital

1 .

. . .

j 1952-1955'- Resident ~- Radiology . Hospital - r

3 of the University-of Pennsylvania.|

--

4 MILITARY SERVICE: None!*

FACULTY APPOINTMENTS: 1958-1960 - Assistant Professor Clinical-Research-Jefferson Medical..ColleEe!

1966-1970 - Assistant Professor Clinical'Radiology-Universityior Penna.School of Medicine

i 1970-1975 - Associate Profes'sor Clinicalj Radiology-Univers'ity.of Penna.

1975-1977 - Professor.of. Pediatrics and.,

Radiology-Hahneman Medical College.

a HOSPITAL APPOINTMENTS: 1950-1952 - Medical StaffNorristown State Hospital,

!

i

.

4

, .

__ ____ ____.__.__.___i ___._.__.__._E__._._._.________1__._m__. _._ _ _ . . _ i _. m._._.__ _ _ _ . .

,_ _ - - - _

. . -2--- .

'h, .,

* *

' HOSPITAL APPOINTMENTS (CON'T): 1955-1960 - Staff RadiologistJefferson Medical College

1960-1972 - Associate Radiologist

"Children's Hospital of

,

Philadelphia '

Consultant-Philadelphia General Hospital '

1972-1974 - Senior RadiologistChildren's Hospital ofPhiladelphia

1974-1975 - Radiology AssociateHospital of the Universityof Penna.

1975-1977 - Attending RadiologistHahneman Hospital

.

1977- - Director of Radiology-A.I. duPont Institute

SPECIALTY CERTIFICATION: 1956- American Board of RadiologyLICENSURE: - Pennsylvania, Delaware

AilARDS: 1948 - Alpha Omega Alpha

1968 - Distinguished Teaching AwardC.H.0,P.

1973 - Distinguished Teaching AwardC.H.O.P.

LEMBERSHIPS (. NATIONAL): 1958 - American Medical Association-

1960 - Society for Pediatric Radiologs1972 American Roentgen Ray Society

1972 - American College of Radiology:

1972 - American Society of NorthAmerica

MEMBERSHIPS (LOCAL): 1958 - Philadelphia Roentgen RaySociety '

1958 ' Philadelphia County Medical^

Society.

7

%

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,-a --

_,- - -

Hopo,J.W.,Borns,Or..andxooP,C.m.: n.

1.. Radiologic Diagnosis of sMediastinal Masse n Infantsv ,

..

and Children. s

Rad. C1., N.A., April, 1963.

2. Hope, J.W., Borns, P.F., and-Koop, C.E.: .

Diagro sis and Treatment of Neuroblastoma and Embryomaof the Kidney.-Rad. C1, N. A., ' December, 1963.

3. Hope, . J.W., Borns, P.F., and Berg, P.K. :Radiological Manifestations of Hirschsprungs Disease.inInfancy. ;

Am. J. Roentgenol. 95:217-229, S'eptember,1965

4 Hope, J.W., and-Borns, P.F.: ,

Radiologica Diagnosis of Primary and Metastatic Cancer inInfants and Children.Rad. C1., N.A. 3:353-374, December, 1965

5 Michie, J.A.3:Borns, P.F., and Ames, M.D. : o

Improvement Following Tubeless Suprapubic Cystostomy of|Myeloteningocele Patients with Hydronephrosis and Recur. rent

- 1Acute Pyelonephritis.Journal of Ped. Surgery 1:347-352, August, 1966.

6 '. Silverman, N.R., Borns, P.F., Goldstein, A.H., Greening, R.R.,'

Hope, J.W.:Thrombus Calcification in the Inferior Vens. Cava: A Specific. Roentgenologic Entity.Am. J. Roentgeology 106:97-102, May, 1969 ,

7. Wagget, J., Johnson, D.G., Borns, P.F., Bishop,_H.C.: .

The Non-operative Treatment of Meconiun Ileus by GastrografinEne=a.J. of Ped. 77:407-411, September, 1970.

8. Salerno, N.R., Manges, J.F., and Borns, P.F.:~

Arthrograms in Hemophilia.-

Radiology 102:135-138, January, 1972.:

9 Borns, P.F. and Johnston, T.A.:Indolent Pneumatosis of the Bowel Wall Associated with Imrm.tneSuppressive Therapy.Ann. de Radiologie 16:163-166, 1973.

.

10. Kohn, G. and Borns, P.F.:The Association of Bilateral and Unilateral Renal Aplasia inthe Same Family.J. of Ped., 83:95-97, July, 1973

.

*

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11. Chung, S. M.K., ait jBorns,P.F. g" Acute Osteomyelitis A'djacent to the Sacioiliac Joint in.

Children." THE JOURNAL OF BONE & JOINT SURGERY Vol. 554,p. 630-634, April, 1973

12. Evans, A., Borns, P.F., Donaldson, M., and Koop, C.E." Cure of the Child with Cancer." PENNSYLVANIA MEDICINEVol. 76, #9, p. 53-57, September, 1973

13 Evans, A., Borns, P.F., and Koop, C.E."The Place of Combination Treatment." SEMINARS IN ONCOLOGYVol. 1, p. 77-80, March, 1974

14 Littman, P., Davis, L.W., Nash, J., Tefft, M., Borns, P.F., andLePanto, P."The Hazard of Acute Radiation Pneumonitis in ChildrenReceiving Mediastinal Radiation." CANCER Vol. 33 p. 1520-1525,June, 1974.

15 Stein, S., Schut, L., and Borns, P.F." Lacunar Skull Deformity and Intelligence in Myelomeningocele."JOURNAL OF NEUROSURGERY Vol. 41, p. 10-13, July, 1974.

.

16. Stolz, J., Borns, P.F., and Schwade, J."The Pediatric Pericardium." RADIOLOGY Vol. 112, p. 159-165,July, 1974

17. Borns, P.F., and Rancier, Lee F." Cerebral Calcification in Childhood Leukemia MimickingSturge-Weber Syndrome." AMERICAN JOURNAL OF ROENTGEN 0 LOGY,RADIUM THERAPY & NUCLEAR MEDICINE, Vol. 122, No 1 p. 22-25,September, 1974.

18. Holgerson, L., Sirouji, M., and Borns, P.F." Isolated Gastric Pneumatosis." JOURNAL OF PEDIATRIC SURGERY"ol. 9, No. 6, p. 813-816, December, 1974

19. Athreya, B.H., Borns, P.F. and Rosebund, M.L." Cystic Fibrosis & Hypertrophic Arthritis in Children."~AM J. DIS. OF CHILD., report of three cases. Vol. 129,No. 5, p . 634- , May, 1975.

20. Azizrad, H., Polgar, G., and Borns, P.F."Ob11terative-Bronchiolitis." CLINICAL PEDIATRIC ~ Vol. 14,p. 572-584, June, 1975.

21. Pasquierello, P.S., Schut, Luis, and Borns, P.F." Benign Increased Intra' cranial Hypertension Due to Chronic~

Vitamin A Overdosage in a 26 Month Old Child." CLINICALPEDIATRICS, Vol. 16, p. 379-382, April, 1977.

22. Borns, P.F. and Moshang, T."The Radiologic Evaluation of Skeletal Maturation."RADIOLOGY SCIENCE UPDATE SERIES #37, 1977.

23. Marks, H.J., Borns, P.F., Steg, N.L., Stine, S., Stroud, H.H., andVates, T.S." Catch up Brain Growth-Demonstration by CAT Scan." THE JOURNALOF PEDIATRICS, Vol. 93, No. 2, p. 254-257, August, 1978.

i'

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s -

CHAPTERS IN BOOKS'

.

1. Borns, P.F., and Hope, J.W.:.

..

.

Radiological Findings in Hutritional Disturbances.Chapter 17-B of Nutritional Distrubances in' Health and Disease,ed. Wohl and Goodhart, 3rd edition, Philadelphia, Lea andFebiger, 1964

.

s

.

.

.

. 9

.

.

.

.

1. :

1

"O T C1. RECORD COPY" |

11.11 .

. ..

.

.Appcndix B ()* * -

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CURRICULUM VITAE.

hame: Marjorie Feng Lou

A.ddress: 20 Stirrup Run, Stirrup Farmshewark, DE 19711Telephone: (302)239-2436

Date sf Birth: September 27, 1939

EqX: Female

Marital Status: Harried (2 Children)

Citizenshio: Chinese Nationality - Naturalized U. S. Citzen

Education:

B.S. Dept. of Agricultural ChemistryNational Taiwan UniversityTaiwan, Republic of ChinaJune, 1960Thesis subject: Analysis of Amino Acids in Mushroom Anaricus

Cameestria and Collvbia Velutines

M.S. Dept. of Biochemistry and NutritionVirginia Polytechnic Institute .

Blacksburg, Virginia, U. S. A.Major: BiochemistryMinor: ChemistryJune, 1962Tnesis subject: Kinetic Studies of Bovine Propionyl Carboxylase

Ph.D. Dept. of BiochemistryBoston University Medical CenterBoston. UniversityBoston, Massachusetts, U. S. A.June, 1966Thesis subject: Inhibition of Enzymes of the Arginine and Pyrimidine

Biosynthetic Pathways by Pyrimidine Metabolites

Professional Societies:

American Chemical Society-(ACS) Ne'w York Academy of_ ScienceAmerican Association for Phi Sigma

the Advancement of Science (AAAS) Sigma XT.Complex Carbohydrate Society

Listed In:

)American Men and homen of Science

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Personal Data (Cont'd)Marjorie Feng Lou

Experience:

Sept. 1960 - June 1962Virginia Polytechnic InstituteResearch Assistant working in the purification and kinetics of

Bovine Propionyl Carboxylase

June 1962 - Sept. 1962Boston UniversityTechnician.in the Department of Biology

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Sept. 1962 - Feb. 1963Boston UniversityTeaching. Assistant

Feb. 1963 - Oct. 1955Boston UniversityResearch Assistant working in the field of EnzymologyPurification of enzymes ornithine. transcarbamylase and carbamyl

phosphate synthetase and studies of their control mechanisms inNeuroscora crassa

Oct. 1965 - Feb. 1967Harvard Medical School .

' howe Lab. of Ophthalmology and the Mass. Eye and Ear Infirmary-Research Associate working in the control mechanism of the

glycolysis pathway in lens

March 1967 - March 1969Alfred I. duPont Institute of The ficmours FoundationDepartment of Biochemistry, Wilmington, DelawareAssistant working in tne field of ino exchange amino acid analysis

and isolation and identification of ninhydrin-positive materialsin human urine

1909 - Sept. 1973Alfred I'. duPont Institute of The Nemours' FoundationResearch Associate

Jan. 1974 - June 1974Academia Sinica, Taiwan, Republic of China IsolationResearch Biochemist working in the field of Enzymology.

of Glycogen Synthetase from Carp Muscle by Affinity Chromatography

Jan. 1974 - May 1974U. S. flavy Medical Research Unit II, Taipei, Taiwan, Republic ofChinaConsultant in Department of Biochemistry

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Harjorie f. Loa l'ersonal Data (Cont'c)

Ex3erienqq 1GQnt'd):

Sept. 1974 - Nov. 19,6Alfred 1. duPont Institute of The Memours FoundationAssociato, studies in the fields of: Biochemistry of Nephrotic

Syndrome, ldiopathic Scoliosis. Isolation and Identification

of Glycopeptides from hormal human brine.

Lee. 1975 - Oct. 1976Alfred 1. duPont Institute of The hemours FoundationActing Chief of Biochesistry

Oct. 1976 - PresentAlfred 1. duPont Institute of The Nemours FoundationAssociateStudies in the field of: the Biochemistry of Muscular Dystrophies,

Collagen Diseases (Osteogenesis Imperfecta; Erhlers-Danlo'sSymdrome)

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RADIATION SAFETY MANUAL

ALFRED I. duPONT INSTITUTE

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June 22, 1979

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TABLE OF CONTENTS

SECTION TITLE PAGE

I. Radiation Safety Committee 1

II. Radiation Safety Officer 2

III. Qualifications For Working In Radioisotope 3

Laboratories

IV. Health Protection Rules For Radioisotope 4

Laboratories

V. General Rules For Radioisotope Laboratories 5

VI. Use Of Animals In Projects 6

VII. Emergency Procedures 7

VIII. Decontamination 7

IX. Control Of The Use Of Radioisotopes In 8Individual Laboratories

X. Procurement Of Radioisotopes 8

XI. Disposal Of Radioactive Waste 9

XII. Record Keeping 10

XIII. Transfer Of Radioactive Materials 11

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I. THE RADIATION SAFETY COMMITTEE

The purpose of the Radiation Safety Committee is the promotionof the best practice in safe handling and use of radioisotopes andradiation-producing devices'throughout the laboratories of the ResearchDivision of the Alfred I. duPont Institute of the Nemours Foundation

(AIduPI).

| The establishment of a Radiation Safety Committee is required' by the federal government before an institutional program for the use of

radioisotopes in research and development under a broad scope will be ;

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licensed.

Federal and state government regulations concerning radioisotopesshall be implemented by the action of the Committee in association with*

individual radioisotope users.

; Radiation, as used herein, includes X rays, gamma rays, alpha

! and beta particles, high' speed electrons, neutrons, protons, and other nuclear

)particles, but not sound or radio waves, or visible.. infrared and ultraviolet

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I The Radiation Safety Committaa is appoin ted by the MedicalDirector of AIduPI.

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Membership shall consist of professional staff experienced inhandling radioisotopes, the use of radiation-producing devices, the practiceof radiation protection, or those who have a desire to institute practicesof safety in regard to radiation.

The activities of the Committee are directed by the RadiationSafety Officer (R.S.O.) and the chairperson who is appointed by the MedicalDirector of AIduPI.,

; Meetings of the Committee shall be called by the chairperson orthe R.S.O. at his/her discretion, not less than once per quarter (calender Vyear) or on petition by any member of the Committee.

A quorum to conduct a meeting includes the R.S.O. plus two members v

of the Committee:

The R.S.O. shall conduct the interim business of the Committeesubject to the approval of the Committee at the next scheduled meeting.

The Radiation Safety Committee will assume the responsibility for_

the radiation safety aspects for all programs involving radioisotopes orradiation-producing devices. Specifically the Committee will:

1. Review and grant or deny permission for the use of radioisotopes inany amount or of radiation-producing devices within the AIduPI fromthe standpoint of radiation safety. A simple majority of the Committee,is required for approval.

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2. Review and prescribe special conditions, requirements and restrictionsthat may be necessary for safe handling of radioisotopes includingadditional training of personnel are physical examinations (e.g. , bloodtests, urine specimens, etc.) before commencing work with radioisotopes,designation of limited areas of use, proper disposal methods and proceduresto be followed after spills or other radiation accidents. The Committeemust approve any, project involving radioisotopes ojt radiation-producingdevices before it can be initiated.

3. Serve as the liaison with the Delaware State Board of Health and theUnited States Nuclear Regulatory Commission in matters of registration,licensing, and radiation safety.

4. Receive and review periodic and/or urgent reports from the RadiationSafety Officer regarding:

a. Results of area monitoringb. Personnel exposures as measured by suitable dosimetersc. Accidents in handling, storage or use of radioisotopesd. Loss or theft of any amount of radioisotopese. Records of radioisotope procurement and disposal

5. Recommend remedial action if safe procedures are not being observed whereionizing radiation hazards exist or if these procedures are not in compliancewith government regulations.

6. Pass judgment in advance of construction of new buildings or remodelingof existing buildings in which the use of radioisotopes or radiation-producing devices is contemplated. Written approval is required from theCommittee for any proposed renovation of laboratories for use of radioactivematerials.

7. Keep radioisotope users advised of current rules and recommendations ofvarious government agencies. concerned with radiation safety and the safeuse of radioisotopes.

8. Keep a written record of actions taken in approving or disapproving the useof radioisotopes and radiation-producing devices and other transactions,communications and reports involved in the work of the Committee.

APPEAL OF ComfITTEE ACTIONS

All actions taken by the Radiation. Safety Committee may be appealedto the Medical Director of AIduPI.

IT. THE RADIATION SAFETY OFFICER (R.S.O.)

The R.S.O. will be appointed by the Medical Director of theAIduPI.

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THE RADIATION SAFETY OFFICER, OR ANY MEMBER OF THE RADIATION SAFETYCOMMITTEE, HAS THE AUTHORITY TO STOP ALL OPERATIONS WITH RADI0 ISOTOPES ORRADIATION-PRODUCING DEVICES WHERE A POTENTIAL HAZARD OR VIOLATION EXISTS. /

RESUMPTION OF OPERATIONS MAY TAKE PLACE ONLY UPON AUTHORIZATION FROM THERADIATION SAFETY COMMIITEE.

The R.S.O. will have the responsibility for ensuring adherence toall regulations issued by or subscribed to by the Radiation Safety Committeeand will advise and assist the Radiation Safety Committee with regard to thecurrent applicable regulations of the United States Nuclear RegulatoryCommission, the United States Public Health Services, state and local agencies,and all similar codes and regulations.

In the absence of the R.S.O., the chairperson or a member of theRadiation Safety Committee will be authorized to act in his/her behalf,consulting with the R.S.O. as to the actions taken when the R.S.O. hasreturned.

Other major areas of responsibility for the R.S.O. will be:

1. Controlling the requisition and procurement, use, transfer and disposalof all radioisotopes through appropriate records to assure an up-to-daterunning inventory of all radioactive materials and devices and to fulfillall federal, state and local regulations.

2. Supervision and maintenance of all personnel records related to radiationsafety practices, including film badge records (or other dosimetry de-vices as deemed appropriate), schedule periodic blood counts and urineanalyses for users where appropriate.

3. Supervise and schedule periodic radiation surveys, wipe tests, leakteets in the laboratories and storage areas.

III. QUALIFICATIONS FOR WORKING IN RADIOISOTOPE LABORATORIES

Certain requirements will be basic in order to qualify to workin a radioisotope area. Each radioisotope laboratory must be under thesupervision of a permit supervisor, usually a person at the professionalstaff level with a college degree at the bachelor's level (or equivalent)in science or engineering and at least 40 clock hours of training and/orexperience in safe handling of radioisotopes. These persons will beapproved by the Radiation Safety Committee based on the person's trainingand experience with radionuclides, projected use, number and amounts ofradionuclides to be used in the project and lab facilities. Other personnelworking in the radioisotope areas will be designated as authorized users ofradioisotopes. They may be working on the project of the permit supervisor 7' ,or carrying out independent research under the general supervision of the ,

licensed supervisor.

The parmit supervisor is responsible for providing instruction to oall potential users in the safe handling of radioisotopes and radiation /

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devices, the characteristics of ionizing radiation, quantities and units ofradiation dose and biological hazards of radiation exposure.

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IV. HEALTH PROTFCTION RULES FOR RADIOISOTOPE LABORATORIES

Every laboratory permitted to use radioisotopes (as determinedby the Radiation Safety Committee) must have the following prominentlyand permanently posted:

1. A copy of our N.R.C. By-Product Material License and all amendments.

2. Title 10 Code of Federal Regulations, Nuclear Regulatory Rules andRegulations, Part 19, " Notices, Instructions and Reports to Workers;Inspections."

3. Title 10 Code of Federal Regulations, Nuclear Regulatory Rules andRegulations, Part 20, " Standards for Protection Against Radiation."

4. Form NRC-3, " Notice to Employees."

5. A copy of our existing Radiation Safety Manual.

6. Proper radiation warning signs in all areas in which work with radio-isotopes is being done.

7. In lieu of 1, 2, and 3 above, an 8 x 5 card can be posted by theR.S.O. stating that the itema are available in the Radiation SafetyOffice.

No one is permitted to work in a radioisotope laboratory atAlduPI unless a pre-employment physical examination is on file in his/herpersonnel record. Every worker in a laboratory using radioisotopes must fwear a film badge provided by the Radiation Safety Officer which will be ~changed quarterly. Permanent records of film badge exposures are main-tained by the Radiation Safety Officer and copies of it are availableupon request.

All personnel using radiolabeled materials (in non-containedforms) may be required to submit a urine sample as determined by theR.S.O. or his appointed representative for counting.

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Any person handling and using in an experiment 50 millicuries ofhydrogen-3 : organic compounds), 25 millicuries of carbon-14,10 millicuries y/

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of phosphorus-32, or 10 millicuries of iodine-125 and/or iodine-131 (non-*

contained forms) shall notify the R.S.O. at least 24 hours in advance ofsuch usage and submit a urine sample for counting. Within 72 hours afterhandling and using in an experiment any of the above, the person shallagain submit a urine sample to the R.S.O. for counting.

For personnel using other specific radioactive materials, theCommittee may designate that they shall have routine urine counts at timeintervals determined by the R.S.O. or when gross contamination levels inthe laboratory in which they work show incidence of improper handling.

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Records of these urine counts will be maintained permanently inthe office of the R.S.O. and placed once per year in the employee's medicalrecords.

Individuals who are known or suspected to have accidentallyswallowed, inhaled, absorbed, or otherwise ingested radioactive materials'

: will be required to submit urine specimens to the R.S.O. for analysis' and counting. The number and frequency of such samples will be established{ by the R.S.O. based on type and level of material and condition of intake.i

| Depending on the particular radionuclide, its chemical and

{ physical form and the mode of intake, the R.S.O. is authorized tg requirej the submission of other excreta (such as fecal samples, nose wipes, or

breath samples) in addition to or in lieu of urine samples.4

In the case of real or suspected intake of gamma-er ing nuclides,

whole body counting may be required in addition to or in lies excreta

samples. The Radiation Safety Officer will arrange such proce .res.

V. GENERAL RULES FOR RADIOISOTOPE LABORATORIES|

There are certain general rules that are applicable to alllaboratory personnel involved in the use of radioisotopes:

1. Wear film badge at all times.:

2. Wear laboratory garments, preferably disposable, over or instead of,,

street clothing.'

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3. Wear protective gloves whenever possible and practical..

4. No smoking, eating, or drinking. Lipstick or other cosmetics andlotions are not to be applied in the laboratory.

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5. Positively no pipetting by mouth; use remote pipetters.

6. Work as much as possible in hooded areas. Projects with I-125 or I-131(non-contained forms) and any project which will generate gases, dustsor vapors shall be confined to hoods having the proper flow rates andfiltration. ;

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8. Monitor all areas where radioisotopes have been used once weekly to,

check for possible contamination. (For details, see Record Keeping,Section XII, #5.) Contamination shall not be allowed to remain onworking surfaces or floors unless properly shielded. (Contaminationis 8 y activity > 100 dpm or a activity > 20 dpm as determined by

!2smear test on a surface of 100 cm ,

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9. All vessels containing radioactive material must be clearly labeledwith a " Radioactive - Caution" label which includes the followinginformation: The type of radionuclide, the specific activity of thematerial and the date of preparation.

10. Plan experiments ahead so that accident or spillage is minimized and,if spilled, the material is properly trapped. Use of trays lined withabsorbent paper and bench surfaces covered with " diaper paper" willaid in this direction.

11. Report immediately to the R.S.O. the details of spills or other accidentsinvolving radioisotopes.

VI. USE OF ANIMALS IN PROJECTS

1. Radioactive materials shall be administered only to animals owned byAlduPI. Any administrations to animals not owned by the AIduPI shallbe cleared with the R.S.O.

2. All cages containing animals into which radioactive materials havebeen injected shall be marked with radioactive warning tags.

3. All dead animals which have been injected with radioactive materialsshall be considered as radioactive waste. Feces and urine from animalsinjected with radioactive materials must be considered radioactive wastes.

4. All animals injected with radioactive materials shall be held in thepermit surervisor's laboratory. Cages shall be placed in the hood oranimals placed in metabolism cages capable of trapping by filter anyairborne radionuclides expired by the animal and excreta. Permitsupervisors and authorized users shall be responsible for cleaningand decontamination of the cages and filters and care of the animals.All animals and excreta are considered radioactive waste as per paragraph 3.

5. All animals injected with radioactive materials shall be sacrificed whenthe projected use or the animal is finished. The carcasses should befrozen and held for radioactive waste disposal.

6. All animals injected with radioactive materials shall be tagged insuch a way as to ensure that, when the animal dies or is sacrificed,it will be considered as radioactive waste and will be properly dis-posed of through the required channels. Animals may be tagged by earnotc) es or by other appropriate means. Tagging must be tied to therecor. 'og so that, when the animal dies or is sacrificed, the radio-nuclide used and amounts injected or remaining in the carcass will beknown.

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7. No animals injected with radioactive materials can be cared for by the /f

animal caretaker or returned to the animal colony.

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VII. EMERGENCY PROCEDURES

In the event of an accident (spill, ingestion, overexposure, etc.).

notify the Radiation Safety Officer as promptly as possiple,.

1. Personnel contamination should be treated as follows:

a. Remain in the area and call for help. This will prevent the spreadof radioactivity.

b. Remove all contaminated clothing.c. Immediately flush any possible contaminated cuts with running water.d. Attempt to wash off any contamination of the skin.e. Monitor all persons involved in the spill and cleanup to determine

adequacy of decontamination.f. Establish by appropriate methods the extent of the incident.

2. Area Contamination

a. The area should be immediately closed to all personnel except thosenecessary to cope with the situation.

b. Confine the spill immediately.

Liquid Spills

(1) Put on protective gloves.(2) Drop absorbent paper on spill.

Dry Spills

(1) Put on protective gloves.(2) Dampen thoroughly and drop absorbent paper on spill, taking care

not to spread the contamination.

c. Decontaminate and monitor appropriately.d. Monitor all persons involved in the spill and cleanup.e. Establish by appropriate methods the extent of the incident.

VIII. DECONTAMINATION

1. Hands and Body

Avoid use of organic solvents since they increase the permeability,a.

of the skin.b. Wash hands with mild soap and tepid water, lather for 2 minutes.c. Monitor.d. If this procedure fails, apply titanium dioxide paste to the affected

area, spread, rinse, dry and monitor again. !

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2. Laboratory Equipment

a. Glassware, porcelain, metals and plastica should be washed withdecontaminating agents immediately after use, followed by rinsing.The vashings and rinsings should be treated as radioactiv.e waste.Then continue by washing in a dishwasher or other usual neacs.

b. Cleaning agents such as Isoclean, De-Con, EbTA, concentrated nitricacid, ammonium citrate and penta sodium triphosphate may be used.

c. Metal tools and similar equipment should be washed with a detergentand scrubbed briskly to dislodge trapped contamination. If

necessary, equipment may be washed in stronger agents includingdilute nitric acid or a 10% solution of sodium citrate.

IX. CONTROL OF THE USE OF RADIOISOTOPES IN_ INDIVIDUAL LABORATORIES

The Radiation Safety Committee will be responalble for assigninglimitations to each radioisotope labaratory with regard to the followings

1. What isotopes can be. used.

2. The maximum permissible amount allowable.

3. Any conditions doened necessary by the Radioisotope Safety Ccamitteeto maintain a high standard of safety.

Whenever an investigator wishes to begin studies utilizing radio-active materials, he must submit a project permit application describing hisplans to the R.S.O. for consideration by the Radiation Safety Committee.

NO WORK IN THE AlduPI WITH RADI0 ISOTOPES CAN BE INITIATED LWLESSTHIS PROCESS IS STRICTLY ADUERED TO.

The Radiation Safety Committee, furthermore, has the right tomake periodic checks into the status of ongolog projects in order toascertain that radiation safety procedures and all related rules and regu-lations are being followed.

X. PROCUREMENT OF RADI0 ISOTOPES

Radioactive material requisitions for all radioactive materialsand radiation devicen must be directed to the R.S.O. (using a specialrequisition form for radioactive materials), who will verify that therequest adheres to the limit;<1tions of our N.R.C. By-Product MaterialLicense, the linics of .i;w for the permit supervisors and those of ourRadiation Safety Counittee. Upon receipt of any purchased radioactivematerial, prior to delivery to the individual user, the package will bechecked for contamination and logged in by the R.C.O. The package willthen be turned over to the responsible individual user along with ausage form (Radioisotope Inventory) with an original and a copy. Whenever

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part of the material is resnoved froin its containet, this form vill be used-*

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to note the user, date, amount withdrawn and its final disposition. Whenthe material is depleted, the usago form should be appropriately glotatedand the original retc,rned to the R.SsO. The user will retain the carbon!

copy. The ncebanism provides a ineans for maintaining a renning inventory

|- of all isotopes used throughout the facilitiss. Once a year, in May, itwill be reqaired that each responsible investigator provide the R.S 0. atotal inventory of radioisotopes on hand at chat tioe in order to veri'Eythat stil records of inventory concur.

I XI. DI!iPOSAL OF RADIDACTIVE WA*TS

! The primary means of disposal of radioactive waste or vastesuspected of being conteminated ytth radioactivity 13 vin radioactive

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war.cc tlrucs provided by a cocznercial vendor (presently Teledyoc inc.).Solid wastes can be disposed of into 5, 30, or 55 gallon drums; liquid.waste can be collected in 3, 30 or 55 gallon liquid drums and solidified

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with an acceptable medium as cu Telcdync's specifications. When full, '

1 cach drum is eealed cad labeled nccordingly Vith the following information:1

! 1. Users' names,o a

! 2. Isotope (s).I )

3. Approximate quantity of radioactivity.

4. Inclusive dates when vaste was collected.,

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In addition to being written on the drum's label, this sameinformation must be logged (or a copy of the drum label) into a disposal |record retained in each user's laboratory; this log will be subjecr to |inspection periodically by the. 2.3.0.

Animal carcasses shall be placed in a plastic bag, sealed andtagged with a " Radioactive Materials" sign. The tag should also state

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1. User's name. j

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2. Isotope (s). )

3. Amount injected.

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Carcasses so pacPaged will be placed in the freezer provided and |held until there is a sufficient number to fill a 55 gallon barrel according |to packing specifications of Teledyne Inc. !

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The R.S.O. will be responsible for packing, preparing the barrel,and recording the amounts of radioisotopes in the animal carcasses fordisposal via Teledyne Inc.

Each animal carcass placed in the freezer must be noted in thewaste disposal record of the individual laboratory. The R.S.O. Will postrequirements for packing radioactive wastes in accordance with specificationsreceived from Teledyne Inc.

In addition, it is possible to dispose of soluble radioactivewaste via the sewer as described by Section 20.303 of Title 10, Chapter 1,Code of Federal Regulations - Energy, " Standards for Protection AgainstRadiation" which permits the daily disposal into sanitary sewage system ofno more than ten times the amounts specified for each isotope in Appendix Cof Section 20. For the radioisotopes included in our By-Product MaterialLicense, the daily limits are as follows:

Radionuclide Maximum Daily

Curbon-14 1.0 millicurieHydrogen-3 10.0 millicuriesCalcium-45 100.0 microcuriesIodine-125 10.0 microcuriesSulfur-35 1.0 millicuriePhosphorus-32 100.0 microcuries

However, the total quantity released into the sewage systempermitted per year of all radioactive material cannot exceed one curieper year. Therefore, disposal via sewage is not encouraged except as

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related to cleaning contaminated glassware and laboratory equipment.Any disposal via the sewage system must be noted in the waste disposalrecord of the individual laboratory.

XII. RECORD KEEPING

Written records are required by federal regulation and NuclearRegulatory Commission standards. The following records will be kept:

1. Receipt and disposition of all radioisotopes and radiation-producingdevices (maintained by both the individual user and the R.S.O.) .

2. The names of all personnel working with radioisotopes under the By-Product Material License (maintained by the R.S.O.).

3. Film badge records are an AlduP1 requirement (maintained by the R.S.O.and documented in your personnel medical record once yearly).

4. Records of all assays such as blood cell counts, urine counts andwhole body monitoring (R.S.O. and documented in your personnel medicalrecord once yearly) .

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5. Every laboratory using radioisotopes must wipe test the areas utilizedonce each week to check M contamination. The location of the wiped +'areas and counting results (plus control values) must be logged into anArea Monitoring Log maintained by the supervisor of each radioisotopelaboratory. The Area Moultoring Log must contain a diagram of thelaboratory with the monitored area numbers, the net count per minute ateach location, the background, date, the tadionuclides used in the areasince the previous wipe test, and the name of the person who performsthe test. In addition, a representative of 'bc R.S.O. will spot checkby means of unscheduled wipe tests at 1 cast en.:e every three monthn.If isotopes are not being used, tho_ wipe tear is not required.

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ANY LABORATORY USING A GAMMA-EMITTING RADIONUCLIDE (SUCH AS 10 DINE-125) ORA BETA-EMITTER EXCEEDING 0.250 MeV (SUCH AS P-32) MUST MONITOR BY SURVEYMETER THE AREA, CLOTl!TNG AND PERSON AFTER EACH USE OF THESE MATERIALS.

XIII. _ TRANSFER OF RADI0 ACTIVE MATERIALS

Radioactive material shall not be shipped or transferred to orfrom the institute without approval of the Radiation Safety Officer.Approved shipments must be packaged and labeled in accordance wich D.O.T.regulations, the N.R.C. regulations or the U.S, Postal regulations, which-ever is applicable. The R.S.O. should be notified well in advance of theneed to transfer radioactive materials. If the transfer is within theinstitute, notify the R.G.O. to ensure that proper records are maintainedand that the transfer is performed safely.

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E_RADIGIS6 TOPE INVENTORY

BY-PRODUCT MATERIAL LICENSE - 07-16199-01.

Date Permit Number-

Requested by___

Material Description:

NAME

Radionucilde: License Limit Half-Life

Requestedt uC mg S.A. = uC/mg

Vendor , Date Received Catalog Number(Name) Lot Number

Package Contamination Check by R.S,0,

User Amount Used (uC) Date Method of Disposal Date

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Wen radiolabeled material is depleted, licensed supervisor should sign and return carbon i

to the Radiation Safety Officer. Original should be retained for your records.

Permit Supervisor

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RADIOISeTOPE/ INVENTORY

BY-PRODUCT MATERIAL LICENSE - 07-16199-01

Date Permit Number

Requested by

Material Description:

NAME

Radionuclide: License Limit half-LifeRequested: uC mg S.A. = uC/mg_

Vendor Date Received Catalog Number(Name) Lot Number

Package Contamination Check by R.S.O.

User Amount Used (uC) Date Method of Disposal Date

When radiolab~ led caterial in depleted, licensed supervisor should sign and return carbone

to the Radiation Safety Officer. Original should be retained for your records.

(Permit Supervisor)

Radionuclide: License Limit Half-LifeRequested: uC mg S.A. = uC/mg

Vendor Date Received Catalog Numbery(Name) Lot Number

Package Contamination Check by R.S.O.

User Amotrnt_Used (uC) Date Method of Disposal Date

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Rh n radiolabeled material is depleted, licensed supervisor should sign and return carbonto the Radiation Safety Of ficer. Original should be retained for your records.

(Permit Supervisor)

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b A. I. DUFONI, INSTITUTEG

AUTHORIZATION REQUEST FOR RADI0 ACTIVE MATERIALS

FOR USE BY RADIATION SAFETY CO)D11TTEE

Approved Denied Permit #

Renewal New Amendment-

Remarks

Signed for Radiation Safety Committee and Date

1. Name

(Please type or print clearly.)

2. Radioactive materials for which approval is requested- I

Maximum Activity in mci onNuclide(s) Chemical /Physice.1 Form (s) Hand at Any One Time

a.

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c.

d.

c.

3. Participating personnel:

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b.

c.

d.

e.

Fill out Training and Experience form for each person.

4. Statement of Request and Agreement:The applicant named and participating personnel hereby request authorization to workwith radioisotopes and/or radiation devices as specified herein and set forth in

i associated supportive documents which may be attached. These individuals by virtuel

of their signatures below, signify that they have read and are willing to abide bythe AIduPI regulations governing the use of radioisotopes and other sources ofionizing radiation. The undersigned ag'ree to comply strictly with the rules and

( regulations and hereby waive any right or recourse against AIduPI for any damageswhatscover resulting from any failure to fully conform with those regulations.

Date Signed

i Date Signed

Date Signed-

Date Signed

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bPROJECT h.2 0 SAL FOR'USE dF RADIOACTIVE MATERIALS

Date: New Project Amendment Renewal

1. Outline the purpose'and method of your project. (Give sufficient detail concerning the

problem and methods of use of the radioactive material to provide a basis for an evaluationof health hazards and contamination potential.) _

.

.2. Identify all procedures (e.g. . purification procedure, synthesis plant studies, etc.).

which may cause particular problems and evaluate any radiation hazard from (a) thequantity of radioactivity in starting material, (b) the volatile, disposal of radio-active wastes, and (c) other contaminated items.

3. Note the instrumentation or methods used to ascertain the radiation level present dueto item a, b, and e in question #2. (List make, model, and range for radiation monitors.)

,

4. Indicate storage conditions for the material, including location and type of possiblecontandnation. (Specify design thickness and type of shielding material which will beused if applicable.)

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5. Specify the-precautions and procedures that will be taken during your possession ofthe nuclide to:

(a) Prevent unauthorized removal of radioactive material.

(b) Prevent contamination and excessive levels of radiation in work or adjacent area.

*If nuclide is to be used in plants or animals, please answer item 6 thru 11 inclusive.6. Plant or animal to be used: 7. Avg. weight of animals:

8. Number of plants or animals to be used: 9. Amount of isotope per plant or

animal

10. Route of administration:

11. Do you anticipate that radioactivity will be contained in the exhaled air: Yes No;

Urine? Yes No; Feces? Yes No; Carcass? Yes No; Roots? Yes No;

Leaves?_Yes No; Stem? Yes No.

*If any of the above answered yes, please describe in detail the procedures and methodsyou will employ to control and/or prevent the spread of contamination.

12. Isotopes requested if not previously authorized.

Maximum Activity in mci on

Nuclide(s) Chemical / Physical Form (s) Hand at Any One Time

a. .

b.

c.

d._

e.

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-Approval requeated by: Date:

Approved: Date:Chairman, Radiation Sa %ty Committee

w__.____________.... _ -. _ _ _ ___

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STATEMENT OF TRAINING AND EXPERIENCE

1.- . Name 2. Supervisor's Name

3.. Type of Training

Dates andFormal Duration of

T)pe Course On the Job Where Trained ~ Training

'Principles and Practicesof Radiation Protection Yes No Yes No

Radioactivity Measurement,Monitoring Techniques,and Instruments _Yes _ No _Yes _No

Mathematics and Calculations '

Basic to'the Use and Measure-ment of Radioactivity Yes No Yes No

Biological Effects ofRadiation Yes- No Yes No

4. Formal Courses (If "Yes" for any of items above, complete this item, listing all coursespertaining to use of radiation or radioactive materials.

,

Title of Course Where Trained Course Content

(A)t

(B)

(C)

(D)

5. Experience (List actual use of radioactive materials)

Dates &Isotope Maximum Amount Where Experience Duration Type of Use

. . .

-

6. Is previous exposure record on file with Radiation Safety Officer? Yes- No

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FACILITY APPROVAL

Building Room

1. Sketch of laboratory:

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| 2. Type of flooring:

3. h is and ceiling: (paint or costing)

4. Bench top material:i

!

5. Hood (s) single ducted directly to outside? Yes No: Filtered? Yes No:

Flow rate at full sash Linear ft/ min.

6. Monitoring device in facility: Yes No. (If yes and haven't '.isted device inproject proposal, list make, model, type and range.)

.

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7. Special handling facilities (shielding, glove boxes, etc.):1

8. Staff members in charge of laboratory:,

! 9. Individual submitting this request: Date

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