*}.~tv rrrLTrzwerrrxtr1rr:mgw.;T2p3gtwursn.~rsmrrrrrrwry.twarsgsy: . > 4 Nne ro,m sta - O---O1 1 5 -% - - '| MATERIALS LICENSE Amendment No. 55 j h Pursuant to the Atomic Energy Act of 1054, as amended, the Energy Reorganization Act of 1974 (Public ! E 93 - 438), and Title 10, j (!g/ Code of Federal Regulations, Chapter 1. Paits 30,31,32,33,34,35,40 and 70 and in reliance on statements and representations ' y | heretofore made by the bcensce, a license is hereby issued authorizing the beenv; \b ecene, acquire, possess, and transfer byproduct, ! ( source, and special nuclear matenal designated below; to use such material 4 the p rposc(s) and at the place (s) designated below.to , deliver or transfer such matenal to persons authonted to rectne it in ecordance eith the regulations of the applicable Part(s). T.his N license shall be deemed to contain the conjitions specif d m Section 153 of th. Atomic Energy Act of 1954, as amended, and if N}Ej , subject to all applicable rules, regulations and orders of tra N'uclear Replatory ( immission now or hereafter in effart and to any >- j- '4 conditions specified below. !; ) 1 = , i. " " ' " In accordance with application dated | s ' l August 10, 1987, 1' j1.YaleUniversity 3. Ucense number 06-00183-03 is amended in i' l. 314 Wright Nuclear Structure its entirety to read as follows: || f] Laboratory West _ !:j 2 260 Whitney Avenue - '! 9 'l New Haven, Connecticut 06520 4. Expiration date May 31, 1994 N 4(4 / o 5. Docket or Re ference No q/ ' 030-00582 ,l 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maxtmum amount that licensee y ' 4 special nuclear material form may possess at any one time M f under this license j A. Any byproduct material A. Any A. 500 millicuries each {i between Atomic Numbers nuclide - Total 50 j , (p , W(4 3 and 84 inclusive curies 5 i B. Hydrogen 3 B. Any B. 200 curies |p % C. Sulfur 35 C. Any C. 35 curies vi 4 0. Cobalt 60 D. Metallic wire D. 2 curies j} E. Copper 64 E. Any E. 25 curies i: , F. Strontium 90 F. Sealed Source F. 600 millicuries j' G. Cesium 137 G. Sealed Source G. 12 curies j, i H. Thorium 228 H. Any H. 115 millicuries 4 I.-Neptunium 239 1. Any I. I millicurie S , i J. Americium 241 J. Any J. 25 millicuries 9 4 K. Americium 241 K. Am-Be Sealed Source K. 300 millicuries @h' i L. Californium 252 L. Any L. 3.5 millicuries M. Uranium 232 M. Any M. 1 millicurie h ' N. Iridium 192 N. 3 Sealed Sources N. 12 curies p 0. Neptunium 237 0. Any 0, 1 millicurie 3). ;j! Q. Americium 241 . Q. Sealed Source Q. 250 m1111 curies i' P. Thulium 170 P. Any P. 5 curies i I R. Curium 248 R. Electroplated tar 9et R. 4 microcuries i' , L S. Protactinium 234 S. Any S. 1 millicurie i, | T. Actinium 227 T. Any T. 1 millicurie |, ; U. Cesium 137 V. Sealed Sources (ICN V. 8 curies, 2 sources :i i Model 70007, formerly ) of 4 curies each I} V.S. Nuclear Model 375 |4 V. Protactinium 233 V. Any V. 1 millicurie i' W. Americium 241 W. Any Sealed Sources W. 40 curies, no source to 'g Q exceed 10 curies pi ] X, lodine 125 X. Seeds X. 3.0 curies jp, 9 9103080162 890523 h j REG 1 LIC30 f= c MATLSLICENSING PDR ii $ 0FFICIAL RECORD COPY ML 10 f1 3 w~ , La 7 .. | m .-~-.--gag m.- m m-.n.--. ~ u|a 1 l
Transcript
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'| MATERIALS LICENSE Amendment No. 55 jhPursuant to the Atomic Energy Act of 1054, as amended, the Energy Reorganization Act of 1974 (Public ! E 93 - 438), and Title 10, j(!g/Code of Federal Regulations, Chapter 1. Paits 30,31,32,33,34,35,40 and 70 and in reliance on statements and representations
'
y | heretofore made by the bcensce, a license is hereby issued authorizing the beenv; \b ecene, acquire, possess, and transfer byproduct, !( source, and special nuclear matenal designated below; to use such material 4 the p rposc(s) and at the place (s) designated below.to
, deliver or transfer such matenal to persons authonted to rectne it in ecordance eith the regulations of the applicable Part(s). T.his Nlicense shall be deemed to contain the conjitions specif d m Section 153 of th. Atomic Energy Act of 1954, as amended, and if
N}Ej,
subject to all applicable rules, regulations and orders of tra N'uclear Replatory ( immission now or hereafter in effart and to any>-
j-'4
conditions specified below. !; )1= , i." " ' "
In accordance with application dated |s' l August 10, 1987, 1'j1.YaleUniversity 3. Ucense number 06-00183-03 is amended in i'
l. 314 Wright Nuclear Structure its entirety to read as follows: ||f] Laboratory West_ !:j 2 260 Whitney Avenue -
'!
9'l New Haven, Connecticut 06520 4. Expiration date May 31, 1994 N
4(4/
o
5. Docket orRe ference No
. q/'
030-00582,l 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maxtmum amount that licensee y'
4 special nuclear material form may possess at any one time M
f under this license
j A. Any byproduct material A. Any A. 500 millicuries each {ibetween Atomic Numbers nuclide - Total 50 j,
(p ,W(4
3 and 84 inclusive curies5 i
B. Hydrogen 3 B. Any B. 200 curies |p% C. Sulfur 35 C. Any C. 35 curies vi4 0. Cobalt 60 D. Metallic wire D. 2 curies j}
E. Copper 64 E. Any E. 25 curies i:,
F. Strontium 90 F. Sealed Source F. 600 millicuries j'G. Cesium 137 G. Sealed Source G. 12 curies j,
i H. Thorium 228 H. Any H. 115 millicuries 4
I.-Neptunium 239 1. Any I. I millicurie S,
i J. Americium 241 J. Any J. 25 millicuries 94 K. Americium 241 K. Am-Be Sealed Source K. 300 millicuries
@h'i L. Californium 252 L. Any L. 3.5 millicuriesM. Uranium 232 M. Any M. 1 millicurie h
'
N. Iridium 192 N. 3 Sealed Sources N. 12 curies p0. Neptunium 237 0. Any 0, 1 millicurie 3).;j!Q. Americium 241
.
Q. Sealed Source Q. 250 m1111 curies i'
P. Thulium 170 P. Any P. 5 curies i IR. Curium 248 R. Electroplated tar 9et R. 4 microcuries i',
L S. Protactinium 234 S. Any S. 1 millicurie i,| T. Actinium 227 T. Any T. 1 millicurie |,; U. Cesium 137 V. Sealed Sources (ICN V. 8 curies, 2 sources :i
iModel 70007, formerly ) of 4 curies each I}V.S. Nuclear Model 375 |4V. Protactinium 233 V. Any V. 1 millicurie i'
W. Americium 241 W. Any Sealed Sources W. 40 curies, no source to 'gQ exceed 10 curies pi] X, lodine 125 X. Seeds X. 3.0 curies jp,
9 9103080162 890523 hj REG 1 LIC30.
f=c MATLSLICENSING PDR ii
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q MATERIALE LICENSE g g g ,,, g - p4 $UPiLEMENT ARY SHEET
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g,0, 00'J32 b<i__ __
, Amendment No. SS p
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9 Authorized use ,>
A. through. X. (1) Research and developcent as defined in Section 30.4(q) c* 10 CFR| Part 30. yg (2) Teaching and training of students, p !
(3) Calibration of survey instruments for individuals and institutions (with associations or affiliation with Yale University.[
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| 10. Licensed material shall be used onlyratior[on the premises possessed by, or under
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the direct control of Mle Unifersityi New Havbni" Connecticut.q
q. gV g -)i 11. A. Licensed material shall be used by, or under the'su'pervision of,
|H'
| individuals designated by the University Radiation * Safety Cc%nittee,q Franklin Hutchinson, Ph.D., Chainnan. The Radiation-Safety Connittee may pg approve individuals;from outside the University .to .be"adthorized as Principal y
Investigatorsfunder the' Yale License to use radioactive materials on Yale+
Universitj premises provided the individual's' background and training are<d apprcpriate!% ,
\yQ ) C] / p ; (>.
| The RadiationsSafety Officer for this|lic\ M i|* < mT.4ense11s George R fHoleman. $B.,
.
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A(1) Each sealed ,sourcetor detector cell acquired 5froni |an,othe[ person andq 12. WsI centaining licensed material, other|than:lidrogen 3, with a half-life dI greater than 30,deys;and in any. form 'other than gas shall'be tested for
|h[ contamination"and/or leakage;behre .u'ses ; fin the absence ~of a certificateg from a transferor, indicating that a' test'hasibe'en made1within 6 months yp before the transfer, a sealed source or/ detector cell received from )li another person shal,1,.not be put'into|use until testedt b || vy &q (2) Notwithstanding the periodic leak test required b'y'this condition, any }?
',licensed sealed source orJdetector celleis esempt from such leak tests p|p( when the source or detector cell conta' ins 100 microcuries or less of beta y
q and/or gama emitting materials or 10 microcuries or luss of alpha >4 emitting material. W4
8I (3) Except for alpha sources, the periodic leak tast required by this condi-f tion does not apply to sealed sources that are stored and not being used. |gq The sources excepted from this test shall be tested for leakage before p
,
N any use or transfer to another person unless they have bten leak tested >i within 6 months before the date of use or transfer. F
,
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,
4B. Each sealed source or detector cell 1abricated by the licensee shall be
q inspected and tested for construction defects, leakage, and contaminationg prior to use or transfer as a sealed source or detector cell. If the( inspection or test reveals any construction defects or 0.005 microcurie9 or greater of contamination, the source shall not be used or transferred .
j as a sealed source or detector cell until it has been repaired, decontami-.
| Amendment No. 55 f< ha (12 continued) CONDITIONS ha h9 C. Each scaled source containing licensed material, other than hydrogen 3 E
[p5 with a half-life greater than 30 days and in any form other than gas] shall be tested for leakage and/or contamination at intervals not to
exceed 6 months except that each source designed for the purpose of b;e
< emitting alpha particles shall be tested at intervals not to exceed 3isl
f months. h
| The te,,t shall be capable of detecting the presence of 0.005 microcurie p.*
s of radioactive material on the; test 7 sample. . lhe icct sample shall be pi taken from the sealed sour'ce"or detehtor cell'or from the surfaces of the ilD4 device in which the sealed" source or detect 6r cell is permanently or k4 emipermanently mounted or stored on i,bich one might expect contamination
. h(j to accumulate. Records cf leak test results shall"be'kept in units of; microcuries and maintained for inspection by the Commission. Records may y
be disposed of following Comission inspection.M 'M gj gJ b; /J 1h.
4 E. If the test required by: Subsection A. or C.''ofi his endition reveals the Ftj presence of 0.005 microcurie 'or more'of removable contam'in' tion, the I$a
| licensee shall immediately wi_thdraw'th'e scaled source or detector cell h1; from use and shall cause jt:to be" decontaminated and repaired or to be pi disposed of ,in accordance with;CoEission- regulations. A: report shall be il
filed within 5 days of'th' date"the11cak t'est' result is known with the >{W ei U. S. Nuclear Regulatory ;Commissioni Regjori'1, ATTH:' Chief, Nuclear >1
i475 Allendale Road, King of Prussia, h9
Materials Safety and. Safeguards' Branch;hihent involved sthe test results,h') Pennsylvania 19406,' describing 1 the 'equq and the correcthe action-taken. * O s <-
-
' . '|p y Q f.:4 y, a4 13. Licensei mitorial shall not be a d intor on human beings. '
3 . . , ,
( 14. Experinental animt.ls admiiiistered licensed materials r eir products shall fg not be used for human consumption J y j, $
p!q n ,is b -
i,W 15. In lieu of using the conventional rac"ation caution colors (magenta or purplef on yellow background) as provided in Section 20.203(a)(1), of 10 CFR Part 20,I the licensee is hereby authorized to label detector cells and cell baths, con- 1
taining licensed material and used in gas chromatography devices, with con- hy.spicuously etched or stamped radiation caution symbols without a color ifrequirement.
' % .5. A. Detector cells containing titanium tritide foil shall only be used in conjunc- >|
| tion with a properly operating temperature control mechanism which prevents $
g foil temperatures from exceeding 225 degrees Centigrade. h4 il4 B. Detector cells containing scandium tritide foil shall only be used in conjunc- pi tion with a properly operating temperature control mechanism which prevents
[tj foil temperatures from exceeding 325 degrees Centigrade.< rki GW [< i
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17. The licensee shall conduct a physical inventory evcry 6 months to account for hall sources and/or devices received and possessed under the license. Records yof inventories shall be maintained for 2 years from the date of cach inventory. p
18. The licensee may transport licen:,ed material in accordance with tha provisions kof 10 CFR Part 71, " Packaging and Transportation of Radioactive Material". g,
19. The licensee is acthorized to hold radioactive material with a physical-half- f'life of less than 05 days for decay-in-storage-before disposal in ordinarvtrash provided: C Lt t t ' L C:- |{f ,
F. \f (. 4A.- Radioact1ve waste to*be disposed of in tnis manner shall be held for de-
cayaminimumofQ0. half-lives. 'qey v
B. Before disposal a's nonnal waste, radioactive waste-shall be surveyed todetermine that' its radioactivity cannot be distingu~ishedifrom background.-
All radiation 11abels shall?be removed or obliterated.
Radioactive,[wastescontainingmicrocuri /b; O>%M N GDw
C.to the ordinary trash afteribeing' held.es, amounts of iodine-125 may be disposedq
for decay for a minimum of five (5) 1
half-lives.PPrior to disposal?Tthese'~ns'tes must t'e monMred in accordance '~
with the procedures described.in-the ,lidenseefs, letter dated June 5, 1985. Theo
g|survey condu'cted priur to dispos'al[must| confirm that thelradioactivity of the
be distinguished from ; background. - / %wastes cannotf
ns!20.106(b) & f" R; U Q 1b & r:W: O yPursuant to Sectio %authorized to dispose-of licensed materialiby.10"CFR Part 20fthe licensee is
20. and 20.302.>of yincineration provided the gaseous ef- p
fluent:from incineration;does not exceed,ths' limits specified for air in Appendix B, hTable-II 10 CFR Part 206 Ash residues may be disposed'of as ordinary waste k
.provided appropriate surysys pursuant to Section 20.201'of 10 CFR Part 20 are made fto determine that concentrations 1of;, licensed,matstial appearing in the ash residues gdo-not exceed the concentrations (initerms ~ofumicrocuries per gram) specified for pwater in Appendix B. Table II,10 CFR Part 20. pl
4 (Continued) COND1110NS >A . > ,4 21. Except as specifically provided otherwise in this license, the licensee shall )gj conduct its program in accordance with the statements, representations, andq procedures contained in the documents including any enclosures, listed below. W1 The Nucle;:r Regulatory Conmission's regulations shall govern unless the state-
$< ments, repre:ientations and procedures in the licensee's application and corre- F
j spondence are more restrictive than the regulations, fF
Nj A. Application dated August 10, 1987hj 8 Letter dated August 18, 1987~ -
.
T; ,
W C. Letter dated September 15,51987 ' '/ /'*'
5 D. Letter dated December 21, 1987~
d'
]iE. Letter dated February 8, 1988 l'F. Letter dated March 23, 1988 - I'i
7,G. Letter dated July?7,1988 L, g4
a H. Letter dated October'11, 1988 g 'M, pi 1. Letter dated No'vember 14',.1988 ., t W. ,
P24 J. Letter dated December 15,;1988 x-
,
4 K. Letter dated' April 27, 1989: \ sec. / ( If.4 - ' j .e r i ,E I_,
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8 10d F(i For the U.S. Nuclear Regulatory Commission F!
|iDate [IOriginal Signed By:
MAY 231989 Laurence F. Friedman, Ph.D, >8y
Q Nuclear Materials Safety Branch h1 Region I dKing of Prussia, pennsylvania 19406 gsamassaxxswaxxxraumasa,s.maxxaxmas.wmwxmwwwexxmwxmtan
Please find enclosed the renewal of your NRC Material License.
Please review the enclosed document carefully and be sure that you understandall conditions. If there are any errors or questions, please notify theRegion I Material Licensing Section, (215) 337-5239, so that we can provideappropriate corrections and answers.
Please be advised that you must conduct your program involvinq licensedradioactive materials in accordance with the conditions of your NRC license,
; representations made in your license application, and NRC regulations. Inparticular, please note the items in the enclosed, " Requirements fer MaterialsLicensees."
Since serious consequences to employees and the public can result from failureto comply with NRC requirements, the NRC expects licensees to pay meticulous
-attention to detail and to achieve the high standard of compliance which theNRC expects of its licensees.
You will be periodically inspected by NRC. A fee may be charged forinspections in accordance with 10 CFR Part 170. Failure to conduct yourprogram safely and in accordance with NRC regulations, license conditions, andrepresentations made in your license application and supplemental correspondencewith NRC will result in prompt and vigorous enforcement action against you.This could include issuance of a notice of violation, or in case of seriousviolations, an imposition of a civil penalty or an order suspending, modifyingIor revoking your license as specified in the General Policy and Procedures forNRC Enforcement Actions, 10 CFR Part 2, Appendix C.
,
e
OFFICIAL RECORD COPY ML 06-00183-03/LTR - 0001.0.0g g 05/17/89 |
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Yale University 2
1
We wish you success in operating a safe and effective licensed program.
Sincerely,
Original Signed Br.Laurence F. Friedman, Ph.D.
Lautence F. Friedman, Ph.D., C.H.P.Senior Health PhysicistNuclear Materials Safety Section 8Division of Radiation Safety
and Safeguards
Enclosures:1. Amendment No. 552. Requirements for Materials Licensees
,
DRSS:RI/pmb
5/R/89
'
0FFICIAL RECORD COPY ML 06-00183-03/LTR - 0002.0.005/17/89
__- ____
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+ 9 9Ya e Umversity n=2" = " ,
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April 27, 1989
Mr. John Kinnerman, ChiefNuclear Regulatory Commiasion' Region 1 Material Licensi.'a Section
475 Allendale Road-King of Prussia, Pa. 19406
Dear Mr.-Kinnerman:
Subject: Yale University License No. 06-00183-03Request for License Amendment
-This letter represents an application for a license amendment to theYale University Broad License No.. 06-00183-03. Specifically, we request thatour license under Conditions, Item 10, Location, be amended as follows:
the addition of 25 Science Park, New Haven, Ct., 06511. - '
Yale University,will lease this space from Science Park DevelopmentCorporation, 5 Science Park,^New Haven, Ct.. 06511. The space under-
cow ideration is typically a biomedical research laboratory, a portion ofwhich'was previously used by International Biotechnologies, Inc. under their -
? Nuclear Regulatory Commission License No. 06-21254-01. It is ourfunderstanding'that International Biotechnologies, Inc. actively retain space-
--at the Science Park facility on-the second floor.
We have: enclosed copies of floor plans which outline-the International-
Biotechnologies, Inc.: space on the second floor of 25 Science Park, and the-
-space Yale _ University intends to lease _on the third, fourth,-and fifth floors;<-- however, the final leasing decision may, or may not, include all the space-
' indicated on the floor' plans. For your information, we have also enclosed a-
Copy of aLS,chnc9.Pgg br{chure which includes a map of the area.
If you have any questions concerning this correspondence, please 'contactInd!O!Uhc.ej/J30]}j
Very truly yours,_
(/bQProf. Edward A. AdelberDeputy Provost for thet jBiomedical Sciences [
EAA:cm _ ,qm_Enclosures up-i v v i w
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lluilding 2525 Science Park
New Ilaven, CT 06511
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E Location: hiunson Street at intersection of Winchester Avenue.Easy access to air, train, and port facilities and one hour drive to ;
every major city in Connecticut. j
Access: 5 minutes from 1-91 and I 95 Interstates. |
E Size: 6 story buikling with 189,000 rentable square feet.
Type of Spnee: Office, wet and dry Labs, and 11 & D space.
Cost: $6.00 - 12.50 sf(It&D & office) and $20.00 sf for wet I, abs.
Ihrking: 2 free spaces per 1,000 square feet rented and additional
spaces $15 per month.
E Amenities: 24 hour security and 24-hour, access on-site services
E Contact: llonni Itabin, hlarketing hianager, at 203 786-5000.
Science Park Development Corporation, I'ive Science Park,
New Ilaven, Connecticut 06511.
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SECURITY
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The--Science Park Development Corporation has enteredinto a'contractural' arrangement with the Ogden SecuritySystems,=Inc. for a full-scale security system at the Park. ,
>This system'wascdosigned and implemented-in.1983 under thedirection:of Ogdeti and Counter Intelligence Systems ofConnecticut. The program is under the on-site direction of.Mr. .
. Robert Terguson (Retired - How Itaven Police Department, 1982), f
-ltr..Ferguson. served,at-the rank of Lieutenant at the time of ,",hiso retirement. ~ In the six years of-full' operation,.the
existing security system can point-to-a successful recot;d thatincludes no attacks onipetsonnel and no record of automotivetheft.or: vandalism in the Park.. Other supportive services arealso provided.a's=needed'to-all residents within.the Park upon ,
request.,
The. security' system designed by Counter Intelligenceincludes fourteen (14)T-operational cameras, an electronically,sensitized perimeter. fence, a bank of. monitors.in two buildings '
for observation,. video; recording. capabilities and remote,
control audio system,at both gates. In addition to theresident- Director of ' Security (R. Fergunon), there is a forceof'fiftoen-(15) g'uards< assigned to duty at the Park. Withinthis-compliment of' personnel there are gate personnel, asecurity car patrol and a 24-hour main desk attendant (rank ofeither captain or: sergeant). Science Park gates are openflonday (through: Friday f rom 6:00 a.m. _ to 6:00 p.m. Access at--other-times-is-providedLvin the remote camera / audio system thatisilinked from the gate entrances to1the main. Security-Desk in. 1
FIVE-Science Park North.. The_ security system is backed up byan:on-site emergency generator.
.for all residents at~the Park. This ID system is integratedinto the Parking system which provides specific identificationfor all resident vehicles. -All visitors-to the Park are signed
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'#OFFICE OF THE P110VOST
YALE UNIVERSITY
1
December 15,1988
Dr. Laurence F. FriedmanNuclear Material Safety Section BDivision of Radiation Safety and SafeguardsUnited States Nuclear Regulatory Commission475 Allendale RoadKing of Prussia, Pa.19406
This letter is in support of our current license renewal. In the renewal applicationdated August 18,1987, an organizational chart was given. Since that time the safety groupsat Yale University have been reorganized. Enclosed is a memo from the Provost, Mr.Frank M. Turner, and the Vice President, Mr. Michael Finnerty, dated November 18,1988giving the details. As of January 1,1984the Radiation Safety Officer (Mr. George R.Holeman) will report through the Director of University Safety to the Provost's Office.
Please contact me if there are questions.
Very truly yours,
Ob(c
Edward A. A elbergDeputy Provost
Enc.
cc: George Holeman
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OFFICE OF Tile PROVOST
To: Deans, Directors and Department Heads
From: Frank M. Turner and Michael Finnerty
Re: Reornanization of the University's Occupational andEnvironmental Health and Safety Offices
As part'of the University's continuing efforts to maintain asafe and healthful environment for its faculty, staff and students,we are undertaking a reorganization of the departments responsiblefor occupational and environmental health and safety at Yale. Thechanges, which result from a year-long review of the University'ssafety organization, will heighten the profile and improve theeffectiveness of those programs in an increasingly complextechnical and regulatory world.
The focus of the reorganization is the creation of a newOffice of University Safety, the Director of which will report tothe Provost. Included within this office will be the Departmentsof Biological Safety (including environmental safety), ChemicalSafety, and Radiation Safety, which previously have been part ofthe University Health Services' Division of Occupational andEnvironmental Health and Safety.
The Office of University Safety will be responsible forenforcement of University and governmental safety regulations and ,
development and improvement of safety training programs forfaculty, staff and students; it will work with the UniversityDiological Safety, Chemical Safety and Radiation Safety Committeesand will also cooperate with the joint labor-management safetycommittee. The Office will also work with other Universityoffices, including the Office of the Fire Marshal and theDepartment of Human Resources, and with the New Haven community andgovernmental agencies in developing and coordinating policies tokeep the University a safe place to work and study.,
The Department of Occupational Safety will be renamed the,
Division of Physical Safety and transferred to the Department ofHuman Resources. Human Resources will also be responsible foradministration of the University's workers' compensation program.
The Department of Employee Health will continue to be part ofthe University Health Services, and will report directly to theDirector of the University He'lth Services.a
These changes will become effective on January 1, 1989. Asearch is already underway for the new Director of University-Safety. Deputy Provost Edward Adelberg is chairing the searchcommittee.
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November 14, 1988
U.S. Nuclear Ragulatory Commission.
Region 1475 Allendale RoadKing of Prussia, Pa. 19406
Gentlemen:
Subject: License No. 06-00183-03Yale University Radiation Safety CommitteeNew Members
This letter is to inform the Nuclear Regulatory Commission of recentchanges in membership of Yale University's Radiation Safety Committee. Newmembars include: Prof. Donald M. Crothers, William D. Stempel, Esq., andProf. Sami S. Zoghbi. Prof. Zoghbi is also a member of the Committee's sub-committee for the review of applications to use radioactive materials. Mr.William Stempel replaces Dorothy Rrbinson on the Committee. The curriculumvitae for each new member is enclosed.
For your information, I have enclosed an up-to-date listing of theRadiation Safety Committee membership. If there are any questions, pleasecontact me. [2,0 3) d3 2 - JV14,
Very truly yours,
,f| n m
! loc- --/hk,,.._.N,.----. % b( h- Edward A. Adelber
R o mit te r _ . -- ph [,Jr'A, w-~ ~ ~'Deputy Provost for theC h e d N o - h& "- ~ ~ " ~ ~ ~ ~ Biomedical Sciences'yAmcuntgM rFeeC2"or+ ,gg'y ]EAA:cm ,y j- jgjTm td ,rEnclosures _-
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0FFICIAL RECORD COPY g7g NOV 181988.
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DONALD M.-CROTHERS
Professor of Chemistry and Molecular Biophys'cs & BlochemistryYale University
Born: January 28, 1937, Fatchgarh, India
Education:
Yale University B.S. 1958 ChemistryCambridge University B.A 1960 BiochemihtryU. C. San Diego Ph.D. 1963 ChemistryMax Planck Instutute, Postdoctoral 1964 Biophysical
Cuttingen chemistryProfessional Experience:
Yale University, Departments of Chemistry and MolecularBiophysics and Biochemistry:
Assistant Professor 1964-1968Associate Professor 1968-1971Professor 1971-presentChairman of Chemistry 1975-1981Alfred E. Kemp Professor 1985-present
Section (N II) 1974-76 1972 1976Co Chairman, Nucleic (Chairman,Acids Gordon Con erence 1975council Member,. Biophysical Society 1979-1982Publications Committee,-Biophysical Society 1982-1985Editorial Board, Ann. Rev. Phys Chem. 1981-1985Consultant for Molecular Diagnostics, Inc. 1982-Biophysics Review Committee, Swedish National
Research Council 1982
Honors:
National Finalist, Jestinghouse Science Talent Search, 1954Yale B;S. - Summa cum Laude, with exceptional distinction
in-Chemistrydlass'I Honours1958Cambridre B.A. - 1960Mellon fellow at Clare College dambridge, 1958-60NSF Postdoctoral Fellow, 1963 54Yale Science and Engineering Award for Contributions toGuggenheim Fellow, plied Science,Basic and Ap 1977
1978 1979Alexander von Humbolt U.S. Senior Scientist Award 1981Fellow, American Academy of Arts and Sciences, 1986Member, National Academy of Sciences, 1987
Recent publications:
147. Topological Distributions and the Torsional Rigidity of DNA: A MonteCarlo' Stud S, D. Levene & D. M. Crothers, J. Nol.Biol .189, y of DNA Circles ,73-83 (1986).
148. Higher Order Structure of Chromatin: Evidence from PhotochemicallyDetected Linear Dichroism, D. Sen, S. Mitra & D. M. Crothers, Biochemi-stry 25, 3441-3447 (1986).
149. Bending and Flexibility of Kinetoplast DNA S. D. Levene, H. M. Wu & D.M. Crothers,-Biochemistry 25, 3988-3995 (1$86).
150. Kinetics and Sequence Specificity of Drug-DNA Interactions: An in
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vitro Transcri tion Assay, D. R. Phillips & D. . M. Crothels, Blochemi-stry 25 7355-7 62 (1986)
151. The DNA Binding Domain and Bending Angle of E. Coli CAP Protein H.-N.Liu Johnson, H. R. Gartenberg 6 D. M. Crothers, Cell 47 905-1005(1986).
152. The Homeo Domain of a Murine Protein Binds 5' to its Own llomeo Box, A.Fainsod L. D. Bonarad, T. Ruusala, M. Lubin D. M. Crothers & F. R.Ruddle,, Proc. Natr. Acad. Sci. U.S.A. 83 9532,9536 (1986).
153. Proton Nuelear Magnetic Resonance Studies on Bulge-Containing DNAOligonucleotides from a Mutational Hot-Spot Se S. A. Woodson &D. M. Crothers, Blochemistry 26, 904 912 (1987)quence,
.
154. Cel electrop(horesis of ?rotein-DNA Complexes , D. M. Crothers, Nature325 464-465 1987).
155. A Stressed Intermediate in the Formation of Stably & D.Initiated RNA Chainsat the E. coli lac UV5 Promoter, D. C. Straney M. Crothers, J.Mol Biol. 193 267-278 (1987).
156. Comparison of the Open Complexes Formed b Polymerase at the E.Straney & D. y RNACrothers, J. Mol. Biol.coli lac UV5 Promoter, D. C. M.193, 279-292 (1987).
157. Anthracycline Antibiotics. Interaction with DNA and Nucl eosomes andInhibition of DNA Synthesis,inger and D. M.-H. Fritzsche, U. Wuhnert, J. B. Chaires,N. Dattagupta F. B. Schless Crothers, Biochemistry 26,1996 2000 (1987),
158. Effect of Drup-lac Promoter, b.DNA Interactions u Initiation at theStraney and D.pon TranscriptionCrothers, Blochemistry 26, 1987-C. M.
1995 (1987).
159. Chemical Determinants of DNA Bending at Adonine-Thymine Tracts, ll.-S.Kao and D. M. Crothers, Blochemistry 26, 3745-3748 (1987).160. Effects of Antitumor Drugs on Transcription D. M. Crothers, D. C.
Straney and D. R. Phillips in " Molecular Mecha,nisms of Carcinogenic andAntitumor Activity", C. Cha as and B. Pullman eds, PontificlacAcademiac Scientiarum Scripta aria 70, 403-424 (1987)
161. Kinetics of the Stages of Transcription Initiation at the Escherichlaecli lac UV5 Promoter, S. B. Straney and D. M. Crothers, Blochemistry26, 5063 5070 (1987).
162. DNA Bend' Direction by Phase Sensitive Detection, S. S. Zinkel and- D. M.Crothers, Nature 328, 178-181 (1987).
163.LacRgressorisaTransientGeneActivatingProtein,S.B.StraneyandD. M. rothers, Cell 51, 699-707 (1987)
.164.. Preferential Location of Bulged Guanosine Internal to a G.C Tract by *HNMR, S. A. Woodson and D. M. Crothers, Blochemistry 27, 436-445, 1988.
165. Calibration of DNA Curvature and a Unified . Description of Sequence-Directed DNA Lendinc H.-S. Koo and D. M. Crothers, Proc. Natl. Acad.Scl. USA 85, 1763-17d7 (1988).
166. Structural Model for an 011gonucleotido Containing a BulD ged Guanosineh. Crothers,by NMR and Ener A. Woodson andBlochemisery 27, gy Minimization} . S.3130 3141 (1988
167. The Major Adduct of the 4ntitumor Drug Cis-diamminedichloroplatinum(II)i bends the duplex by =40 toward the Ma
Pinto and S. J. Lippard,jor GrooveProc . Natl. J .A. Rice, D. M.
i Crothers A. L. Acad. Sci. USA 85,:. 4158-4161 (1988).
| 168. DNA Sequence Determinants of CAP-Induced Bendin and Protein BindineCro the rs ,g Nature 333, 824-820| Af fini ty, M. R. Gartenberg and D. M.
;_ (1988).I
! 169. Phased Psoralen Crosslinks Do Not Bend the DNA Double Helix, T. E.| Haran and D. M. Crothers, Blochemistry 27, 6967-6971 (1988),
k Business: P.O.. Box 107 4 Yale S tationNew Haven, Connecticut 06520(203) 432-4940
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.NME: Sami S. Zoghbi
DATE OF BIRTH: May 29, 1948
- teRITAL STA'IUS: Married July 24, 1971 to lenaChaghouri
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BUSINESS ADDRESS: Yale' University, School'ofMedicine a
iDepartment of DiagnosticRadiology333 Cedar StreetNew Haven, CT 06510
BUSINESS TELEPHONE: (203) 785-4908.
EDUCATION:'
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Purdue University, West Lafayette, Indiana1974'-'1978Bionucleonics (Health Physics and TracerMethodology), Ph.D.
1971'- 1974 Ball' State University, Muncie, Indiana-Molecular' Biology, M.S.
1969 - 1971' Anderson College, Anderson, IndianaBiology / Chemistry, B.A.
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PROFESSIONAL EXPERIENCE:
March, 1986 - Present Member of Radioisotope Camtittee, Yale-NeggyJuly, 1984 - Present Assistant Professor, Yale
University School of m dicine,Department of DiagnosticRadiology, New Haven, CT
Sept., 1982 - Present Medical Staff (Affiliated HealthCare Professional), Yale-NewHaven Hospital, New Haven, CT
July, 1981 - Present Director of RadiochemistryIResearch Laboratory, Yale
University School of m dicine,Department of DiagnosticRadiology, New Haven, CT
Aug., 1978 - July, 1981 Research Associate, YaleUniversity School of Medicine,Department of Diagnostic )Radiology, New Haven, CT I
iMay, 1977 - Aug., 1978 Research Assistant,
Post-Doctorate, BlonucleonicsDepartment, School of Pharmacy
Aug., 1974 - May, 1977 Graduate Teaching Assistant,Bionucleonics Department, School ;
of PhaITnacy i
Dec., 1972 - May, 1974 Graduate Laboratory Assistant,Ball State University
Jan., 1969 - May, 1971 Undergraduate LaboratoryAssistant, Anderson College,Biology Department
SCCIETIES AND HONORS:
The Health Physics Society - 1977 i
The Society of Nuclear Medicine - 1978Society of Sigma Xi - 1978Naninated to the Albert and Anna Kienly Award
i
for Excellence in Teaching and Recipient of the !
Departmental Award for Excellence in Teachingby a Graduate Student - 1977
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WWUSCRIPTS SUBMITTED:.
1. Zoghbi, S.S., Thakur, M.L., Gottschalk, A., Marasco, W.A., andBecker, E.L.: A Potential Padioactive Agent for the SelectiveLabeling of Human Neutrophils. Subnitted to: Int. J. Acol.
Radio. Is L
2. Neumann, R.D., Zoghbi, S.S., Kirkwood, J.M., Ernstoff, M.S.,Ziyadeh, T., Fine, J.A., and Unger, M.W.:-Radioimmunoscintigraphy of Patients with Metastatic MelanomaUsing Indium-111-DTPA Conjugated Anti-GP-240 Marine MonoclonalAntibody (Type ZMS-018) . In Preparation.
3. Neumann, R D., Zoghbi, S.S., Kirkwood, J.M., Ernstoff, M.S.,
Cornelius,E.A.,FingJ.A.,Unger,M.W.,Ziyadeh,T.:Phamacokinetics of In-DTPA Labeled Anti-gp240 MurineMonoclonal Antibody (Type ZME-018) in Patients with Metastatic
Ernstoff, M.S., Unger, M.M. Comparison of Tumor Size andMonoclonal Antibody Uptake within and Betweer 7atients inMelanoma. Subnitted to J. Nucl. Med.
6. Majumdar, S., Pope C.F., Zoghbi, S.S., Bamirez, A., Gore,J.C.: Mechanisms of Relaxation Rate Enhancement fromSuperparamagnetic Contrast Ager^. in Tissue and Gels.Subnitted to 281
PUBLICATIONS:
-- 1 '.' Thesis-Awarded M.S. The Effect of pH on the Fatty AcidComposition of Penicillium Chrysogenum. Ball StateUniversity, Muncle, Indiana. July, 1975.
2. Thesis-Awarded Ph,D. Effect of N-Mathylglucamine Salicylateon the Gastrointestinal Absorption of Alpha Methyldopa inRats. Purdue University, West Lafayette, Indiana. May, 1978.
-3. Thakur, M.L., and Zoghbi, S.S.: Radiophamaceuticals:Structure-activity Relationship in Cell Labelling. Spencer RPEd., Grune & Scratton Publishing, Inc., New York, 1981.
4. -Sostman, H.D., Neumann, R.D., Lake, J.D., Zoghbi, S.S.,
Gottschalk, A., and Greenspan, R.H.: Detection of PulmonaryEmboli in Man with In-111 Platelets: Case Report. Am. J.Roentoenol., 138:945, 1982.
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PUBLICATIONS (cont'di:
5. . Sostman, M.D. , Neumann, R.D., Zcghbi, S.S. , Thakur, M. ,R., and Gottschalk, A.: Experimental Studies with-
gy,laceled Platelets in Pulfronary Embolism.Indium Invest.
Neumann, R.D., Gottschalk, A., and Greenspan, R.~H.: Platelet~' Kinetics and Biodistribution in Canine Endotoxemia.- Invest.Radiol,- Vol. 18:425, 1983.
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,7 . - Zoghbi, S.S., Thakur, M.L., Sostman, H.D., Neumann, R.D.,I.ord, P. , Gottschalk, A., and Greenspan, R.H. : The Influenceof Heparin on the In Vivo Distribution of In-111 LabeledPlatelets.. Invest . Padiol . , - 20:198-202, 1985.
Zoghbi, S.S., Neumann, R.D., and Gottschalk, A.: A Modified8. .Procedure for RapidJLabelling of Low Concentrations ofBioactive Proteins with Indium-111. Int. J. Nucl. Med.Biol., 12:159-166, 1985.
9. Zoghbi, S.S., Neumann, R.D., and Gottschalk, A.: A PracticalApproach to the Preparation of High Specific ActivityIndium-111-DTPA-Labeled Bioactive Protehs. Springer-VerlagPublishing Inc., New York. In Press.
10. Sostman, H.D., Zoghbi, S.S., and Gore, J.: TemporalFluctuations in Proton Relaxa"lon Times. Mac. Res. Irracina,4:479,1986
11. Zoghbi, S.S., Neumann, R.D., and Gottschalk, A.: The Ultra-purification of -Indium-111 for Radiotracer Studies. Invest.
Radiol . , 21: 710-713, 1986. - ;
12. Zoghbi, S.S., Neumann, R.D., and Gottschalk, A.: Preparationand. Immunoreactivity of Righ Specific Activity ofIndium-111-DTPA Labeled Monoclonal Antibody (MoAb) UsingUltrapure Indium-III M3Ab, Invest. Radiol., 21:788-792, 1986.
14. Zoghbi, S.S., El Bassi, Z., Neumann, R.D., Gottschalk, A.:Quality Control and the Preparative Purification of LowAntibody Concentrations for Badiolabelling Using BifunctionalChelates.-Int. J. Nucl. Med. Biol., 14:529-532, 1987.
15. Chan, Ming S., Hoffer, Paul B., Maric, Nada, Zoghbi, Sami S.,Kirkwood, John M., Ernstoff, Marc S., Duray, Paul H., Gerich,Betsy: Comparison of Gallium-67 Versus Indium-111 MonoclonalAntibody (96.5, ZME-018) in Detection of Hurran Melanoma inAthymic Mice. 1 Nucl. &xL 28: 1441-1446, 1987.
20. _Majumdar, S.,-Zoghbi, S., Pope, C., and Gore, J.C., fFQuantitation of Belaxation Effects of Iron-Oxide Particles-in
Liver and Spleen. Radioloov. (In Press) . |
21. Majumdar, S., Zoghbi, S., Pope, C., and Gore, J.C. : AQuantitative Study of Relaxation Rate Enhancement Produced by s
Iron-Oxide Particles in Polyacrylanide Gels and Tissues. Mac, tResn. Med. (In Press) . -h
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PUBLISFED ABSTRACTS: hI
22. Zoghbi, S.S., and Bennett, A.S.: The Effect of pH of a Medium !on Fatty Acid Synthesis by Penicillium Chrysogenum, I(Presented at the Indiana branch of the American Society for
. Microbiology, Muncie, Indiana) . April,1974.
23. Born,=G.S., Christian, J.E., Kessler, W.V., and Zoghbi, S.S.:The Effect of Vitamin C Upon the Absorption of Ferrous /Fumarate in Dogs. (Presented before the ATericanPharamceutical Association Academy of Pharmacy Practice, 126thAPHA Annual Peeting, Anaheim, California) . 1979.
24.--Sostman, H.D., Neumann, R.D., Zoghbi, S.S., Greenspan, R.H.,and Gottschalk, A.: -Clinical and Experimental Studies of
25. Zoghbi, S.S, Thakur, M.L., Pande, S., Srivastava, S.C., andRichards, P.: Investigations into Agents for Improving CellLabeling with Positron a:xt Gaara Emitting Radionuclides. L__.
'Iphl . Como. Radiocharm. , 18:280, 1981.
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PUBLISHED ABE'"BACTS (cont' d)
26. Zoghbi, S.S., Sostman, D., Neumann, R., Thakur, M., Carbo, P.,
Gottschalk, A., and Greenspan, R.: The Influence of Heparinon the In Vivo Distribution of In-111 Platelets (In-111-P) inan Experinental Canine Model, J. Nucl. n 4 22:p55, 1981,
27. Zoghbi, S.S., Thakur, M.L., Gottschalk, A., Marasco, W.A., andBecker, E.L.: Selective Cell Labeling: A PotentialRadioactive Agent for Labeling.% man Neutrophils. J. Nucl.-
Mt;L 22:p32,1981.
28. Zoghbi, S.S., Neumann, R.D., and Gor.tschalk, .: A SimplifiedMethod for Labeling Bioactive Proteia with 'ndium-111.Padioloav 149(P):243,1983.
Caroo, P., Gottscha]h, A., end Greenspan, R.H.: RadiolabeledFibronectin in Venous Thromoosis and Pulmonary Embolism.Badiology 149(P):243, 1983.
30. Zoghbi, S,5., Neumann, R.D., and Gottschalk, A.: ThePreparation of Righ Specific Activity of Indium-111-DTPALabeled Antibodies (I) .- Hybridoma 3:79, 1984.
31. Zoghbi, S.S., Neumann, R.D., and Gottschalk, A.: ThePreparation of High Specific Activity of Indium-111-DTPALabeled Antibodies (II) . Invest. Radiol. 19:S32, 1984.
32. Zoghbi, S.S., Neumann, R.D., and Gottschalk, A.: A PracticalApproach to the Preparations of High Specific ActivityIndium-in-3TPA-Labeled Bioactive Proteins. J. Nucl. Med.26:439, 1985.
33. Neumann, R.D. , Kirkwood, J.M. , Zoghbi, S.S. , Ernstoff, M.S. ,Cornelius, E.A., Hoffer, P.B., and Gottschalk, A.: Ga-67 vs.In-111-DTPA-Anti-p97 Monoclonal Antibody for Scintigraphic .,
Detection of Metastatic Melanoma. J. Nucl. Med. 26:p15, 1985,s
34. Kirkwood, J.M., Neumann, R.D., Zoghbi, S.S., Ernstoff, M.S.,Ziyadeh, T., Fine, J.A., Shaw, C., and Unger, M.W.:Badioinmunoscintigraphy of Metastatic Melanom withIndium-111-DTPA Conjugated Anti GP-240 Monoclonal AntibodyZME-018. Proceedings of the.AACR 26:296, 1985.
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35. Zoghbi, S.S., El Bassi, Z., Neumann, R.D., and Gottschalk,
A.: Apparent Failure of DTPA Protein Conjugations: Pitfallsand Solutions. J. Nucl. Med. 26:121, 1985.
36. Zoghbi, S.S., Neumnn, R.D., and Gottschalk, A.: The'
Ultrapurification of In-111 for Radiotracer Studies. Invest.Radiol . , 20 :S50, 1985.
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CURRICUID4 VITAEPago 7
PUBLISHED ABSTRACTS (cont'd)
37. Cornelius, E.A., Neumann, R.D., Zoghbi, S.S., Ernstoff, M.S.
and Kirkwood, J.M.: Scintigraphy of Metastatic bhlanomaUtilizing In-III-DTPA Labeled Anti-GP-240 Monoclonal AntibodyZME-018.11ybridoma 5:64; 1986.
38. Zoghbi, S.S., Neumann, R.D., Cornelius, E,A.e Ernstoff, M.S.and Kirkwood, J.M.: The Phamacokinetics of In-III-DTPALabeled Fbnoclonal Antibody anti gp-240 (ZMS-018) in HumanPatients with Metastatic bhlanma liybri&ma 5:87, 1986.
39.- J. Powe, J.F. Chatal, 14 other participants, and S.S.'Zoghbl. The Fifth Annual Congress for Hibridoma Research,Reports from Meetings of Working Groups on Murine FbnoclonalAntibodies Available for Clinical ApplicatJon, livbridoma5:166-170, 1986.
40. Crian, S.M. , Hoffer, P.B. , Maric, N. , Zoghbi, S. , Ernstoff, M. ,Duray, P., Kirkwuod, J., Gerich, B.: Ga-67 Citrate VersusIn-111.Monoclonal Antibody for Detection of Melanoma inAthymic Mice. L. Nucl. MzL 27: 922, 1986.
41. Zoghbi, S.S. and Gottschalk, A.: The In Vivo Kinetics ofIndium-111 ' Labeled Polyclonal Anticollagen Antibody ' (Type-I)for Detection of Tissue Injury in a' Marine Model. Invest.PadioL , 21:S30, 1986.
-42. Cornelius, A.E., Neumann, R.D., Zoghbi, S.S., Ernstoff, M.S.
and Kirkwood, J.M.: Scintigraphy of bbtastatic MelanomaUtilizing In-111-DTPA Labeled Anti-p97 Monoclonal Antibody(MoAb) 96.5. Invest. Radiol., 21:S118,1986.
43. Freimanis, R., Zoghbi, S.S. and Gottschalk, A.: The Effect of.
" Irrelevant" igg Protein Selection on Target Uptake Ratios ofRadiolabelled Antibodies. _ Invest . Radiol., 21:S6,1986.
44. Zoghbi, S.S. and Gottschalk, A.: The Chronic Cannulation ofRat. Jugular Vein to Insure Intravenous Injection and toSimplify Repeated-Dose Delivery or, Blood Withdrawal. Invest.
Kirkwood, J.M. and Unger, M.J.: Radlodetection of FbtanticMelanoma (tH) Using IN-111-DTPA-ZMS-018 Monoclonal Antibody(MoAb).- J. Nucl. Med. 27:1019, 1986.
46. Zeghbi, S.S. and Gottschalk, A.: Indium Labeled Polyclonal,
! Anticollagen Antibody (Type I): Detection and Kinetics ofTissue Injury in a Murine Model. Badloloov,161 (P) :39, 1986.
Ernstoff, M.S., Hoffer P.B., Gottschalk, A., Ga-67 vsIn-111-DTPA-Anti-p97 or In-lll-DTPA-Anti p240 Marine Moabs forscintigraphic Detection of Matastatic M21anma. A Brh MM.28: 573, 1987.
50. Cornelius, E., 14euman, R., Zoghbi, S., Kirkwood, J., Ernstoff,M., Unger, M. Comparison of Tumor Gize and MonoclonalAntibody Uptake within and between Patients in Malanoma. ANucl. Ih h 28: 711, 1987.
51. Zoghbi, S.S., Gottschalk, A.: Detection and Ki.9 tics of TissueInjury in a Marine Model Using Indium-lll LabeleG DolyclonalAnticollagen Antibodies. Invest. Padiol. 22: S27, 1987.
52. Zoghbi, S.S., Gottschalk, A. Indium-lll Labeled Monoclonalo
Anti-Laminin Antibody: Detection of 3asenent Mambrane Injury.8 Innt. Padiol. 22: S 27, 1987.
53. Schulman, D.S. Joufer, R., Zoghbi, S.S., Zaret, B.L., Barash,P.G., Matm y 6 ,, Biondi, J.W. Effect of PositiveEnd-Epirator D assure on Right Ventricular Blood Flow andContractilit) suring Right Coronary Artery Occlusion.Clinical Fes., 35: 324A 1987.
54. Soufer, R., Heiman, D., Zoghbi, S., Melnik, D., Zaret, B.L.:Chlorpromzine Limits Extent of Myocardial Peperfusion Ir. juryIn Dogs. Circulation. 76: Suppl IV: 229, 1987.
55. Schulnen, D.S. , Biondi, J. , Zoghbi, S. , ."atthay, R. , Soufer,R.: Right Ventricular Performance is Limited by Ccronary FlowDuring PEEP in Dogs. Circulation. 76: Suppl IV: 4E, 1987.
56. Vahjen, G., Cornelius, E., Zoghbi, S., Neumann, R., Kirkwood,J., Ernstoff, M., Zubal, G.: Pharmacodynamics and Physiologyof 2 Marine Monoclor.al Antibodies in Man. FASEB Journal 2:A1358, 1988.
*37 . Soufer, R., Zoghbi, S., Mattera, J., Vaivoda, D., Wackers, F.,
Zaret, B.: The Noninvasive Assessnent of White Blood Cell9
Accumulation During P&erfusion Myocardial Injury. L'
Mucl .MM. 29: 954, 19sv.
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. PUBLIS1ED AMTPACTS (cont'd)
58. Valden, C., Comelius, E., Zoghbi, S., Netmann, R., Kirkwcod,J., Ernstoff M., .Stal, G.: Biodistribution and Blood Curvesof 2 Marine Anoclonal Antibodies in Melancrna Pctiecra, mthrl. fed. 29: 1323, 1988.
November 8, 1988 Lal+'alin M ' ''r260 u'/wou3 Aires,Neu llastu, Coneettaent o6uo
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f RESElfLMEMDilR LOURUA14.NRLYDULLTLRADI ATI MJ A FUTLCOMMIITEU
Prof. Franklin llutchinson ChairmanDirector lindergraduate StudiesMolecular Biophysics & Biochemistry
Mr. George R. !!oleman SecretaryDirector Radiation Safety Dept.
Prof. Donald M. Crothers MemberAlfred E. Kemp Professor ofChemistry and Professor ofMolecular Biophysics & Biochemistry
Prof. Alexander Gottschalk MemberVice-ChairmanDiagnostic Radiology
Ms. Lois Nichols MemberAssociate in Research Biology
Dr. Richard Peschel MemberAssoc. ProfessorTherapeutic Radiology
Prof. Jan A. Stolwijk MemberChairman Epidemiology andPublic flealth
William D. Stempel, Esq. MemberDeputy General Counsel
'Prof. Sami S. Zoghbi MemberAsst. ProfessorDiagnostic Radiology ~
0756C
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Ya_e University = || 2 "' = "
October 11, 1988
Dr. Laurence F. FriedmanNuclear Material Safety Section BDivision of Radiation Safety and SafeguardsU. S. Nuclear Regulatory Commission475 Allendale RoadKing of Prussia, Pa. 19406
Dear Dr. Friedman
Subject: License No. 06-00183-03Docket No. 030-00582Control No. 107718Response to your letter of August 17, 1988
The following information is provided in response to your August 17,1986 Ictter.
1. You expressed concern about the fact that there are spaces in theMedical School area which are covered by both the Yale Universitylicense and the Yale-New llavin llospital (YN!!!!) license. The onlysuch area of which we are aware is ,the fif th floor of the !unterRadiation Therapy Building (!!RT). To eliminate this overlap, YNillivill assume complete control over the procedures conducted on thefif th floor of IIRT. +
2. You also requested information about the University's relationship
with YNiill and the John B. Pierce Foundation (Pierce) in connectionwith the University's handling of radioactive waste from YNilli andPierce. YNiill is the University's principal teaching hospital, andtogether with the University's Medical School and Nursing Schooloccupies the Yale-New llaven Medical Center A written affiliationagreement between the University and YNilli provides, among otherthings, for Yale f acu? ty physicians to hold staff positions andprivileges at YNiill. Pierce is a private foundation affiliated withthe University under a written affiliation agreement and locatedacross the street from the Medical School. Pierce's director andmost of its senior staff have Yale faculty appointments. A
University faculty member is thesRadiation Safety Officer for thePierce license.
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O OYale UniversityResponse to NRC letter of 8/17/88Page 2
We formally request aut.horization to collect and processradioactive waste f rom Pierce and YN!!!!. As both organizations areclosely affiliated with the University, we will operate on a " costrecovery" basis with no profit involved, and request exemption fromfees. The University's Radiation Safety Department will continueto pick up, process and prepare for shipment the radioactive wastefrom each organization. This radioactive waste will be identifledand kept separate. YN!!!! and Pierce will eaci. apply to the State ofWashington for a site use permit and become an identified generatorwith the State of Washington. In addition, each organization'sRadiation Safety Officer will inspect each shipment and sign thenecessary shipper's certification. YNiill and Pierce will be billeddirectly by the broker when the radioactive waste is shipped fordisposal; the Univttsity will not be acting as a broker for eitherorganization. In other respects, we anticipate no significantchanges in our current operating procedures for handling ofradioactive wastes.
3. The University is still considering if it will pursue the requestto discard in sanitary landfitis small quantities of radioactivematerial with half-lives less than 300 days. If we decide topursue the option, we will submit a separate amendment at a later
) date. We are closely watching the use of the procedure which isapproved in Texas, an NRC agreement state.
Very truly yours,
O r 3
C A'
prof. Edward A. AdelbergDeputy Provost
EAA:cm
cc: Dr. Eugene CorneliusChairman YN1111 Radiation Safety Committee
Mr. George R. llolemanDirector Yale Uniseralty Radiation Safety Department
Prof. Prtaklin liutchinsonChtteman, Yale University Radiation Safety Committee
In continuing the review of your application to renew the above refer-enced license, some additional points have arisen which require clarifi-cation. Please supply.the following information:
1. During a recent inspection, it came to our attention that thereare spaces in the Medical School area which are covered by both
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the Yale University license and the Yale-New Haven Hospital (YNHH)license. 'These would be laboratories and other areas where 11-censed material related to both human and non-human use is han-died. It is NRC policy NOT to authorize the use of licensed mate-rial in any physical space by two different NRC licensees. Al-though we would prefer that large areas or whole buildings be con-trolled by each licensee, assignment of responsibility may be madeon a room by-room basis, as long as responsibility for any givenarea is clear. This problem may be resolved in other ways, suchas placing both programs under a single license. Please resolvethe issue of responsibility for specific spaces (including corri-dors, stairwells,-and other such areas) and make necessary adjust-ments in your application for renewal. If a conforming amendmentto the YNHH license is required it must be applied for as well.
2.- We are aware that Yale University receives radioactive waste fromYale New Haven Hospital and the John B. Pierce Foundation. Cur-rently the Pierce Foundation license states that waste will bedisposed of by transfer to Yale while the YNHH license does not.
10 CFR 20.301 provides that radioactive waste may be disposed ofonly by transfer to an ' authorized recipient," by one of the othermethods enumerated in Part 20,-or by a method approved by the Com--
mission'under 20.302. While Yale is-authorized to receive thetype, form, and quantity of licensed material contained in thewaste from these institutions, Yale is not specifically authorizedby license to collect radioactive waste. Therefore, you shouldformally request authorization to receive radioactive waste fromthe two named institutions, and describe the procedures you willuse to assure that the operation will be done safely, and to as-
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sure that all applicable regulations, particularly 10 CFR 20.311and those in 49 CFR, are complied with. Since the Commission has,in similar cases, authorized licensees to collect waste fromclosely related institutions without the assessment of the fee ap-plicable to a radioactive waste broker, you should describe yourrelationship with those institutions.
3. With regard to your request in paragraph 6 of your letter datedMarch 23, 1988, to dispose of small quantities of short-lived ra-dionuclides in sanitary landfills, this request must be consi % redunder10CFR20.302(a). Rulemaking would only be required if youdesire to have such disposals included in 10 CFR 20.306. If youwish to pursue this request, please refer to the requirements in10 CFR 20.302(a), and submit all the information described there.If you intend to rely on the report referenced in this letter,please submit a cop) Be advited that, prior to approval of sucha disposal option, the Commission will require assurance that allnecessary local permits have been obtained, and that appropriatestate officials have been given and opportunity to comment on theproposal.
We will continue our review up>n receipt of this information. Pleasereply in duplicate to my attention at the Region 1 office and refer tomail control No. 107718. If you have any questions, please call me at(215) 337-5276.
In order to continue prompt review of your application, we request thatyou submit your response to this letter within 30 calendar days from thedate of this letter.
Sincerely,
c,q snalsL:nodEyL;.a c.a f . ; ric rrm , Ph .D .
Laurence F. Friedman, Ph.D., C.H.P.Senior Health PhysicistNuclear Material S&fety Section BDivision of Radiation Safety andj
Ya_C U111 Vel,S1tyOf fICI Of Tiii. PROVOSTm,.. m,., . c.... ,m.
July 7, 1988
Mr. John KinnermanNuclear Regulatory CommissionRegion I Material Licensing Section475 Allendale Road
? King of Prussia, Pa. 19406
Dear Mr. Kinnerman:
Subject: Yale University License No. 06-00183-03Docket No. 030-00582Control No. 107718
Referring to our current License No. 06-00183-03 and the pendingrenewal, this letter is to advise you that Prof. Franklin llutchinson has beenappointed Chairman of the Yale University Radiatlan Safety Committee,effective July 1, 1988. Prof. Ilutchinson has been a member of the Committeefor many years and a previous Chairman. We enclose his curriculum vitae foryour files.
If there are any questions, please contact me.
Very truly yours,
M%Edward A. AdelbergDeputy Provost
EAA:cmEnclosure
cc: George R. lloleman
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A i G R E F _~
18 JUL E8B<
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() Franklin Jutchinson ().'#
Education
B.S. Massachusetts Instit 'e of Technology,1942 (physics)Ph.D Yale University, 194t (physics)
Research and/or Professional Exot lence
Staff, Radiation Lab, M.I.T., Cambridge, Mass. 1942-1945Instructor, Radiology and Physics, Yale University 1948-1951Assistant Professor, Physics, Yale University 1951-1957Associate Professor, Biophysica, Yale University 1957-1960Program Director, Departmental Training Crant (NIH) 1958-1985Professor, Biophysics, Yale University 1960-Present
' Acting Chairman, Biophysics, Yale University 1960-1961Chairman, Molecular Biophysics, Yale University 1961-1963Cuggenheim Fellowship,. King's College, London, England 1963-1964Chairman, Molecular Biophysics, Yale University 1967-1969Chairman, Molecular Biophysics and Blochemistry, Yale 1973-1976Director of Under.staduate Studies, Molecular Biophysics'
Cordon Research Conference on Mutagenesis, Vice Chairman 1986Chairman -1988
Prof. Hutchinson has been the University Radiation Safety Officer andtwice a past Chairman of the Radiation Safety Committee. He is a biophysicist.and has utilized a wide variety of radioisotopes in his laboratory research.He is also the Principal Investigator for a multi-curic Co-60 irradiator andresponsible for its radiation safety.
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The following information is provided in support of Yale University'scurrent license renewal application and in specific response to your letter ofFebruary 26, 1988.
1. Radiation Safety Committee Review
The sub-committee review of applications to use radioactive maserial atYale will continue to function as previously described; and the actions ofthe sub-committee will be reported for final approval by the Committee atits regular meetings. To facilitate committee action a list of allrenewals and staff comments will be distribute.d to committe members priorto the regular meetings.
2. Training
The primary responsibility for training of employees and students workingin research laboratories rests with the Principal Investigators. Thetraining provided by the principal Investigator is ongoing and continuousin nature starting before the individual begins work with material. Tosupplement that training, the Radiation Safety Department offers a varietyof radiation protection training for the Yale community.
A list of trained individuals, by principal Investigator, is maintained bythe Radiation Safety Department. Files are maintained of all individuals 1
receiving training at the seminars including new users, specialty trainit'g .
on specific isotopes or procedures, or periodic training of ancillary
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Individuals who will be using radioactive material are listed on theapplication to the Committee. During the review of the initialauthorizations, and the three year renewals, the Radiation SafetyDepartment checks its files to verify that each individual listed on theapplication as a user has attended a training session. If someone has notattended a training session, the investigator is informed. Theapplications for film badges are screened to verify each individual hasattended a training session; if not, the individual and PrincipalInvestigator are informed of the requirement.
Additional training and retraining is provided on a non-scheduled basis,based on demonstrated need, potential for problems, the professionaljudgement of a flealth Physicist, or at the request or suggestion of theRadistion Safety Committee. In addition, the staff of the Radiation SafetyDepartment serves as a constant source of information for the Yalecommunity.
3. Survey Frequency
Our inspection records ir' _ .us.ory of compliance with 10 CFR20.201. External and inter.. 1 exposures have been extremely low.Individual Principal Investigators are requested to perform routinesurveys at a frequency related to the use of radioactive material in theirlaboratories. Wherever this has been found inadequate, the RadiationSafety Committee has imposed increased frequency. Current staffing levelsof the Radiation Safety Department make it difficult to meet yoursuggested frequency increase.
The central radioisotope laboratories are supervised by the Radiation '
Safety Department and surveyed following each experiment. Room air, preand post charcoal filtered air samples are collected during iodinationprocedures. Thyroid burden measurements of those utilizing suchfacilities are performed if indicated. Other iodination facilities aresurveyed 11. a similar manner. Again the succeau of our program in theseareas is demonstrated by its history.
It is our opinion that an increase in survey frequency above what isalready performed would impair the effectiveness of a demonstrablysuccessful program.
4 Contamination Guides
Tables 2 and 3 from U.S. NRC Regulatory Guide 8.23 will be used ascontamination guides.
The documented enposures to individuals using 10 mci or greater of 32pat Yale do not justify extending this coverage to all individualsauthorized to use 1 mci or more of 32p. Individuals handling more than10 mci do not receive exposures to the extremities at a level which wouldrequire dosimeters according to 10 CFR 20.201; therefore, it is extremelydiffirait to justify extending this coverage to a population handlingsmaller quantities. The users of 10 mci of 32P do not chow substantialextremity e.xposures (25% or more of the quarterly guides), therefore, theusers of 1 mC1 of 32P should have even lower extremity exposures. Wefeel that increasing the use of finger rings for lower activities acrossthe board is not justified; however, in cases where, upon review of theauthorization o experiments, judgement of the Radiation Safety Departmentstaff indicates that finger rings are needed, they will be assigned.
6. Waste Disposal
It is our understanding after talking with Mr. Rick Jacobi of the TexasLow-Level Radioactive Waste Authority that Texas, as an agreement statewith the NRC, has permitted the disposal of radioisotopes with half-livesof less than one year in sanitary landfills in Texas under certainconditions. We understand this to be in effeet since May, 1987. It isalso Mr. Jacobi's understanding that the NRC has accepted this as a validapproach and is looking into extending its use. As a license condition weare requesting this option with similar conditions as imposed on the TexasUniversities and Medical Centers. Please consider the report by theunsultant to the Texas Low-Level Radioactive Waste Authority in supportcf this request (Reference: Rogers and Associates Engineering Corporationreport no.:RAE-8514-2, " Disposal of Short-Lived Radionuclide Waste in aSanitary Landfill: Final Report" for the Texas Low-Level Radioactive WasteDisposal Authority, February, 1987). We do not feel this requires arulemaking but can be accomplished ac a waste management option under alicense condition.
We also plan to release items for unrestricted use which meet therequirements of Table 3 in the Regulatory Guide 8.23.
7. Miles, I'.
Miles, Inc. is no longer at Yale and is no longer associated with the Yalelicense,
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We hope this information vill satisfactorily answer your questions;however, if there are additional concerns please contact me,
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Very truly your *.
'_ k- Nm R_ %Peter D. Parker, Ph.D.Chairman-Radiation Safety Committee
This is in reference to you letter dated December 21, 1987, in response to theNRC's letter dated October 28, 1987 requesting additional information regardingthe renewal of License No. 06-00183-03. In order to continue our review, weneea the following additional information:
1. We have reviewed the make-up of you. subcommittee as indicated in yourapplication dated August 18, 1987, and find that the subcommittee is notrepresentative of the total radiation safety committee. It appears thatthe subcommittee review is ir reality a radiation safety office staffreview with the chairman of the committee and the staff performing theinterim duties of the committee between full meetings of the committee.The regulations in 10 CFR 33.17(b) and Condition 11. of your licenserequire designation of users by the r m iation safety committee.
Most institutions record in the minutes of the full committee that theactions of the subcommittee vere reported and approved as completed.
Please confirm that the requirements of 10 CFR 33.17(b) and Condition 11.of your license are met, in that, the full committee will now give finalapproval to all subcommittee actions.
2. Please clarify how you assure that individuals receive training outlinedin 10 CFR 19.12 prior to working with radioactive materials or prior tofrequenting a restricted area and how you document that these individualshave received annual refresher training.
3. A licensee must establish a survey program to assure compliance with40 CFR 20.201. Quarterly surveys may not be sufficient in restrictedarea where iodinations with millicurie amounts of iodine 125 or iodine131 are performed or where millicuries amounts of phosphorus 32 are
i used. We suggests that such areas be ,urveyed at least weekly.; Please clarify if your survey frequt:ncy criteria takes into
! consideration a more frequent survey of these types of areas and this! survey is documented.
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4. Please clarify your criteria for removable contamination limits, Theinformation submitted in Item 6.a. and 6.b. of your letter dated December21, 1987 concerns only tritium. What would your limits mean fornickel-63, phosphorus-32, ete? You may set different allowablecontamination limits for each isotopet. as long as the limits are stated
rin dpm/cm . Regulatory Guides 8.21 and 8.23 may be helpful inestablishing removable contamination limits.
5. Item 8.b. of your December 21, 1987 letter states that finger rings areissued to individuals working with 10 millicuries or more ofphosphorus-32 (P-32). The NRC believes that there is a potential ofexceeding 25 percent of the extremity and skin limits in 20.101 whenworking with 1 millicurie or more of P-32. Please justify your issuanceof finger dosimetry for individuals working with 10 millicuries ratherthan 1 millicurie of P-32.
6. Your request to increase the half-life of isotopes held for decay instorage from 65 to 100 day half-life isotopes is acceptable. However,the disposal of isotopes with half-lives of 100-300 days in a sanitarylandfill is not acceptable under present NRC regulations. Such disposalwould require rule making. Your statement that the Texas low-levelRadioactive Waste Disposal Authority's guideline is acceptable to the NRCis incorrect. Please withdraw your waste management proposal fordiscarding these isotopes in a Connecticut sanitary landfill.
7. Please clarify if you still need authorization in for Miles, Inc. tooccupy Yale leased laboratory space.
We will continue our review upon receipt of this information. Please reply induplicate to my attention at the Region I of fice and refer to Mail ControlR5. TMH 8.
In order to continue prompt review of your application, we tequest that yousubmit yo*;r response to this letter within 30 calendar days from the date ofthis letter.
Sinut ely,
brTghini Signed 97tJenny M. Jchancen
Jenny M. Johansen, M.S.Nuclear Materials Safety Section BDivision of Radiation Safety
and Safeguards
Enclosure: Regulatory Guides 8.21 and 8.23
Johansen/mjh (Yg GlennRI:DRSS RI:DRSS
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YALE UNIVERSITY
|- U I. A. W. WRIGilT NUCLEAR STRUCTURE LAllORATORY'' -
P.O. Itox 6666. 272 V'hltney Avenue. New Haven, Connecticut 06$11t
December 21, 1987
Ms. Jenny M. JohansenNuclear Materials Safety Section 11Division of Radiation Safety and SafeguardsNuclear Regulatory CommissionRegion 1-6.11 Park AvenueKing of Prussia, Pa. 19406 >
Dear Ms. Johansent
-Subjects License No. 06-00183-03Docket No. 030-00582 s
Control No. 107718
This is in reply to your letter of.0ctober 28, 1987 requestingadditional'information on the Yale University renewal of License No.06-00183-03.: Our response is addressed to your items numerically as theyappeared in your letter.
'We appreciate your verbal extension'of the response time to permit the. Radiation Safety Committee to participate in discussions and their commentshave been included in the' enclose response.
YALE UNIVERSITY COMMENTS TO NUCLEAR REGULATORY COMMISSION (NRC) in response totheir letter of October 28, 1987
Radiation Safety Committee
1.a. The committee vill schedule at least one meeting per calendar quarter.
1.b. The Yale University Radiation Safety Committee approves theapplications to use radioactive materials via a sub-committee asdescribed in the license renewal dated August 18, 1987. The committeeprocesses hundreds of-applications per year for the use ofradioisotopes within the University under its broad license. Theapplications are for one isotope only and cover a period of threeyears. In order to handle this voluminous workload and to bring theappropriate expertise to the review procean as described in theprevious application, the committee approval is given by thesub-committee. This procedure for handling the review and approvaldates back prior to 1963 and has been used successfully by Yale sincethen. We see no need to change a system that is working successfully.
1.c. A quorum of the Yale University Radiation Safety Committee is amajority of the committee (currently four).
1.d. _ror your information, Dr. Deborah McGregor is no longer at YaleUniversity and is no longer a committee member. Dr. Richard Peschelhas joined the committee.
The present committee members are:
Prof. Peter D._ Parker, ChairmanGeorge R. Holeman, SecretaryDr. Alexander GottschalkProf. Franklin Hutchinson-Ms. Lois NicholsDr. Richard PeschelMs. Dorothy RobinsonProf. Jan Stolvijk
The curriculum vitaen are not included but a summary of experience foreach member is attached.
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Radiation Safety Officer ji
2.a. The Radiation Safety Department is the operational arm of the RadiationSafety Committee. The Director of the Radiation Safety Department isalso the Radiation Safety Officer (RS0). The Radiation SafetyDepartment is responsible fort
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1. Coordinating the Radiation Safety Committee's review of safetyevaluations of all proposed uses of radioactive material.
2. Implementing policy decisions of the Radiation Safety Committee andIproviding information which leads to compliance with appropriate
federal regulations.
3. General surveillance of all radiation safety activities, includinglaboratory, personnel, and environmental monitoring.
4. Furnishing consulting services to training personnel at all levelsof responsibility on all aspects of radiation protection.
5. Establishment of procedures for purchasing, receiving and shippingall radioactive materials coming to or leaving Yale.
6, Instructing personnel in proper safety procedures for working withradioactive materials or radiation producing equipment.
7. Provide radiation seminars upon request for laboratories withconcerns for a specific radioisotope or experimental techniqueinvolving radioisotopes.
8. Monitoring all University accelerators, isotope laboratories, x-raymachines and other equipment capable of producing ionizingelectromagnetic radiation.
9. Disttibution and processing of personnel monitoring devices' including film badges. The keeping of records of internal andexternal personnel exposure, and notifying individuals and their
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Principal Investigators or supervisors of all exposures, as well asrecommending appropriate remedial action for excessive exposures.
10. Operation of and the allocation of space in the RadioisotopeFacilities: 1138 Kline Biology Tower, I-243 Sterling !!all ofMedicine,-and 400 Laboratory of Epidemiology and Public Health.-These laboratories are equipped for the handling of high levels ofactivity.. Space is available in the above laboratories to anyauthorized Yale investigator on an allocation basis.
11. Storage of stock solutions involving large quantities of isotopes.
12. Supervising the leak tests of all sealed sources and maintainingthe required records.
13. Maintaining a centralized quarterly inventory of all radioactivematerials at Yale.
14. Supervision and coordination of the waste diIposal program,including the processing, storage and disposal of radioactive wasteand the maintenance of the required records,
15. Resp?nding to laboratory emergencies involving radioactivematerials and/or personnel contamination.
16. Supervision of decontamination efforts in cases of accidentsinvolving radioactive materials.
17. Monitoring and ensuring adequate maintenance of special filtersystems associated with the use, storage, or disposal ofradioactive material.
2.b. Enclosed is a recent letter concerning the authority of the RadiationSafety Officer.
Training Program
3.a. "The individual sh9Mid shortly thereafter attend a radiation safetyseminar presented by the Radiation Safety Department" has been changedtot "The individual shall shortly thereafter attend a radiation safetyseminar presented by the Radiation Safety Ders.tment".
3.b. The monthly Radiation Safety Seminars which are designed to meet therequirements of 10 CFR Part 19 are listed in the Yale Weekly Calendarof Events and are always open to anyone in the Yale community who maywish to attend including ancillary personnel. In addition, specialradiation safety lectures and visual aids are given to housekeepingsupervisory personnel who convey this information to theirsubordinates; also, the custodians, traffic, receiving and storespersonnel, certain categories of grounds maintenance personnel,construction supervisors have received specific radiation safetytraining to meet the requirements of 10 CFR Part 19. Security personnelhave received radiation safety training and have been instructed tocontact the Radiation Safety Department in the event of any incident oremergency involving radioactive materials. Also, the fire marshal andhis staff of inspectors have been instructed in certain radiationsafety procedures which are pertinent.to the functions of firepersonnel.
User Responsibility
4.a. Individual User Responsibility (Item 4.b.) has been amended to read asfollows:-
Wearing appropriate disposable gloves, laboratory coats, eyeprotection, and following other safety precautions as deemed necessaryby the Radiation Safety Department.
4.b. Individual User Responsibility (Item 4.e.) has been amended to read asfollows:
Using automatic or remote pipette filling devices: pipetting by mouthis forbidden.
4.c. Individual User Responsibility (Item 5) has been amended to read asfollows:
Refrigerators should not be jointly used for food, beverages, andradioactive materials. Individuals shall not eat, smoke, drink orapply cosmetics within a radioactive materials use laboratory except:
1. This prohibition shall not apply when a principal Investigatoris inactive and/or radioactive materials are adequately securedand not in active t 'e within the laboratory, provided thatimmediately after securing radioactive materiale a survey isperformed and documented and any removable contamination foundis removed.
2. When clearly defined radioactive materials work areas aredesignated within an individual laboratory, this prohibitionshall not apply'outside such work areas, provided that (a) allradioactive materials used in quantitles equal to or greater;
than the maximum permissible body burden for that radionuclideare used exclusively inside such work areas, and (b) such workareas are adequate continuous work areas and not discrete" islands", and (c) surveys are conducted outside such workareas demonstrating absence of contamination. For purposes of(a) above, transport of radioactive materials in a container orother holding device that does not leak, where the container orholding device is at no time placed on a surface outside suchwork area, is not considered "use" of such materials outsidesuch work area.
This policy was recently adopted by the Radiation
Surveys
c 5.a. According to 10 CFR 20.201 (b), regarding frequency, surveys arerequired
"as may be necessary for the licensee to comply withthe regulations " and
"as are resonable under the circumstances to evaluatethe extent of radiation hazards that may be present".
The Radiation Safety Committee recognizes that at an academicinstitution survey frequencies, if set, would be as varied as thenumber of research projects performed. It is for this reason that
: principal Investigators are required to perform laboratory monitoringwhich is "resonable" and related to the frequency of their scheduledresearch. The investigators are encouraged but not require 6 to keeprecords of such monitoring. The regulatory requirements are met by theRadiation Safety Department surveys, which are done quarterly, bytrained and experienced Health physics Technicians. These surveys aredocumented. Individual investigator monitoring results are considered,
j supplemental.
i S.b. The Radiation Safety Committee requires surveys as follows:
. The Radiation Safety Department, as a goal, performs surveysquarterly and keeps records of such surveys. Copies of these surveyresults are sent to individual investigators and retained by them.
. Demonstrated problem areas are reviewed by the Committee andadditional requirements are placed on individual investigators. In theextreme case, daily surveys of hands and workareas with copies ofresults are sent to the Radiation Safety Department. Again,such requirements are dictated by the relative hazard present and arevaried.
. It is suggested that individual investigators do their own laboratorymonitoring at a frequency related to their radionuclide use. It issuggested but not required that a record of such monitoring be kept.The Radiation Safety Department performs and documents quarterly
; surveys to satisfy the regulatory requirements.
Radioactive Contamination
6 a. The figure "100 cpm .-bove background" van established as an actionlevel for laboratory contamination follosup. For liquid scintillationcounting of vipe tests, for tritium, this relates to an activity for a100 cm2 wipe of
1.0 to 6.0 x 10-06 uC / cm2,
depending on the counter used,
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| 6.b.- As per 10 CFR 20.5, a net count rate of 100 cpm above background (on'
the liguld scintillation counting equipment presently in use) for a
7.b. - : Packages are received at the J. W. Gibbs receiv ng room at 260 WhitneyAvenue and the Medical School receiving area _at 200 South FrontageRoad. ..During. holiday recesses packages are sometimes received atSterling Chemistry Laboratory, 225 Prospect Street and the Centralstockroom at 10 Science Park.-
7.c. The Radiation Safety Office will provide assistance 2n this procedureupon request by the Principal Investigator when there is reason tosuspect leakage , abnormal radiation rates or other significantproblems.-
7.d. All packages requiring radiation monitoring as required by 20.205(c)(1)are monitored at the surface and at one meter by the Radiation Safety,
Department. All results are recorded. This procedure is performed bythe Radiation Safety Department rather than the Principal Invewtigatorsin order to ensure uniformity and to verify compliance with regulations.
7.e. This statement has been rewritten as follows:
Assume that the package is_ contaminated until checked and wearappropriate protective-gloves while opening any received package.
7.f.- This statement has been amended as follows:
Prior to disposal of an empty uncontaminated container to unrestrictedareas, remove or_ deface the radioactive material label or otherwiseclearly indicate that the container no lon;er contains radioactivematerials.
7.g. The Radiation Safety Department is able to schedule shipping andreceiving of packages so that-off duty deliveries are very rare. If apackage should inadvertantly arrive daring off duty hours , the packageis held by the Campus Police until it can be properly checked and/or i
routed.
7.h. Packages which require radiation monitoring are monitored by radiationsafety personnel, after receipt and prior to delivery to laboratory,with an ion chamber and a vipe test in order to ensure a v oratemeasurement.and-compliance.
Additional Elements
8.a. " Principal Investigator should submit radioactive material inventorydata on a quarterly basis" has been changed to: "The PrincipalInvestigator is required to submit radioactive material inventory data-on a quarterly basis".
" 8.b. Apparently.there is a misunderstanding concerning this item. Therequest for 500 mil 11 curies.of phosphorus-32 is to allow use by 260Principal Investigators at Yale University. And, it is rare that anysingle shipment contains 20 millicuries or greater (usually shipped in2 x 10 millicurie vials). Although certain personnel may be allowed toorder 20 mil 11 curies at-one-time, as a rule they do not use more than10 mil 11 curies at a time. In the rare event that an individual must
use grecter th 0 millicuries, the experimenti )totocol is carefully,
reviewed and ad tional precautions included. Finger rings are issuedfor individuals working with 10 mil 11 curies or more. It is commonpractice to recommend dry runs or reduced activity for initialexperiments involving radioisotopes. Shielding is provided forexperiments utilizing phosphorus-32 compounds when used in theRadiation Safety Department supervised central hot laboratories. Theprinciples of time, distance, and shielding for phosphorus-32experimento are applied throughout the University by the PrincipalInvestigators and Radiation Safety Personnel.
8.c. Hazard evaluations are performed by professional Health Physicists asneeded.
8.d. Quarterly contamination surveys are performed by members of theRadiation Safety staff. Records are maintained in the Radiation SafetyDepartment.
8.e. Leak tests are analyzed by the Radiation Safety Departmsnt's staffmembers. The actual wipe test may be performed by the Princ! palInvestigator or a member of the Radiation Safety staff, however, it isanalyzed by the Radiation Safety Department.
Personnel Dosimeters
9.a. For purposes of crmpliance, personnel monitoring devicer are issued asstipulated in 10 CFR 20,202 and are collected monthly. Othermonitoring devices are issued for various persons and are consideredsupplemental. Generally, such badges are also collected monthly. Ifmonitoring is extended to large groups of auxiliary personnel forpublic relations reasons, then a quarterly TLD service may be utilized.
9.b. Regarding the requirements for thyroid monitoring:
1. Thyroid counts are required as soon as practable when a breathingzone air sample indicates 25% of occupational MPC.
2. Thyroid counts are strongly suggested if a breathing zone airsample indicates 10-25% of an occupational MPC.
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3. Thyroid counts are required when the Radiation Safety Departmentstaff determines that a significant uptake may have occurred due to
an individual event in the lab (i.e.: a skin contamination).
Student Exposure
i 10. When the quantity of radioactive material involved in an individualundergradu9te's experiment is a quantity less than what the NRC
,
! considers an exempt quantity (10 CFR Part 30.18 and Part 30.71,
| Schedule B) then the experiment may be conducted under the present| authorization system of approving the Principal Investigator as the
responsible person. The physical presence of the supervising,
| instructor is not necessary at all times. However, adequateinstructions on the safe use of radioactive materials must be given asan integral part of the experimental protocol. All materials muststill be purchased through the authorized Principal Investigator, andall orders must be placed through the Radiation Safety Department.
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When radioactive materials in quantities in excess of the amount theNRC considers exempt quantities are planned for an undergraduate I
laboratory experiment, then the Principal Investigator must have priorcommittee approval for the experiment and for each laboratoryinstructor who will directly supervise laboratory sessions. At leastone of the approved instructors must be present throughout theexperimental session. As under all other circumstances, allradioactive materials must be purchased through the Radiation SafetyDepartment.
Instrument Calibration
11.a. As a professional courtesy, Yale will, upon request, calibrate certaininstruments for individuals or institutions with association oraffiliation with Yale University.
11.b. We do not intend to calibrate far medical licenseca.
'aste Management
12.a.b.
Please increase storage time for decay in storage from 65 to 100 days.
12.a.b.
Waste with isotopes with half-lives of 100-300 days may be held fordecay but not for the full 10 years required for decay in storage; thismaterial vill be held so that the activity may decay and other disposaloptions may be utilized.
The justification for
"Short half-life radioactive waste with a half-life of less than300 days may be processed and monitored by Radiation SafetyDepartment staff and then discarded in a Connecticut permittedsanitary landfill in accordance with the guideline in " Disposal ofShort-Lived Radionuclide Waste in a Sanitary Landfill FinalReport" dated February, 1987 of the Texas Low-Level RadioactiveWaste Disposal Authority"
is given in the referenced report and is acceptable to the NuclearRegulatory Commission as Texas is an agreement state. Theenvironmental impact can be considered-generic for large landfills andthe impact is considered trivial by the contractor and the State ofTexas.
12.c.
Gaseous or volatile waste may be released to the environment inaccordance with the limits in 10 CFR Part 20, Appendix B, Table II (10CFR Part 20.106).
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As a matter of policy dictated by the Radiation Safety Committee, theperson applying for authorization must be a Faculty Member (Professor,Associate Professor, Assistant Professor, Senior Research Scientist orResearch Scientist) at Yale University. The Radiation SafetyDepartment furnishes application forms and the necessary informationto those qualified persons seeking to order and use radioactivematerial.
If approved, the Principal Investigator or selected persons on hisstaff may place orders for radioactive material through the RadiationSafety Department. The order secretary checks the file of thePrincipal Investigator to be certain that he is authorized to order anduse the isotope and quantity ordered.
If the isotope requested is authorized, the order is placed with thevendor selected by the Principal Investigator and specific instructionsare given pertaining to the Receiving Room to which the material shouldbe shipped. This order (referred to as a " Release" at Yale) is typedand one copy is placed in the Principal Investigator's flic, a secondcopy is sent to the department business office of the PrincipalInvestigator, copies three and four are sent to the appropriateReceiving Room for comparison when the shipment arrives, and forsignature when the package is delivered to the appropriate room andbuilding.
The amount and type of the isotope determines the necessity for theRadiation Safety Department to monitor the package after receipt in theReceiving Room, and before delivery to the Principal Investigator.Monitoring is pre-determined by the order secretary (in accordance with10 CFR Part 20.205) and the copies sent to the Receiving Room are somarked in heavy red type; this alerts the Receiving Room and a call isplaced by that department to the Radiation Safety Department to informthe Radiation Safety Department when the package arrives. The packageis monitored and if within limits the Receiving Room is informed thatit is cleared to be delivered to t.e specific laboratory indicated onthe Release.
For Rules for Safe Use, please see sections Spirille PrincinalInvestinator Responsibilities, Individual User Responsibilit Use ofRadioactive IsotoDef, Enggested Laboratory Saffly Procedures, ndProcedures for Openinn Packanes Containing Radioactive Materia.a of theoriginal application.
Control of Aerosols
14. AEROSOLS, DUSTS, AND GASEOUS PRODUCTS has been rewritten as follows:
Procedures involving aerosols, dusts, or gaseous products , orprocedures which produce airborne contLmination shall, to the extentpracticable, utilize process or other engineering controls, to limitconcentrations of radioactive materials in air to levels below thosewhich delimit an airborne radioactivity area as defined in20.203(d)(1)(ii). Where practical , filters or traps shall beincorporated in the experiment set up to ensure that environmentalreleases are as low as reasonably achievable . Radioactive gases ormaterials with gaseous radioactive daughters must be stored in gastight containers and must be kept in areas having approved ventilation.
B.A. 1954, llarvard College, Magna Cum Laude (Phi Beta Kappa) |
John liarvard Scholarship Award (hon.) for excellence 1
M.D. 1958, Washington University Medical School,St. Louis, Missouri (Alpha Omega Alpha)
Internship.
University of Illinois Research and Educational llospitals 1958-1959
Reaidr_ tis 2
University of Chicago (Radiology), July 1959 - June 1962
Licensure
State of IllinoisState of California 1
State of Connecticut
EcnificationAmerican Board of Radiology, June 1963American Board of Nuclear Medicine, May 1973American Board of Radiology - Special Competence in Nuclear'
Medicine, June 1974
Consultantshing
National lleart Institute - Urokinase, Streptokinase,
Pulmonary Embolism, 1967-1973
National Institutes of General Medicine Sciences-Radiology Training Committee, Reasearch Training GrantsBranch, 1970-1973FDA Advisory Committee on Radiopharmaceuticals, 1970-74.
Dr. Gottschalk has been head of Nuclear Medicine at both the University _of Chicago and Yale University. As such, he was responsibio for radiationsafety of the full range of medical isotopes in both patient care andlaboratory research.
* 4.
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George R. Holeman
' EXPERIENCE - EDUCATIONAL%
Degree / Year Institution Pleid of Study
B. A. - 1960 Centre College Physics /Hathematles.
of KentuckyDanville, Ky.
A. H. - 1961 liarvard University P.n ginee. Ing/Cambridge, Ha. llealth Physics
EXPERIENCE - PROFESSIONAL
Organleation Yeare Position
liarvard University 1960 - 1961 .U. S. Atomic Energy} Cambridge, Ha. Commission (AEC) llecith
I'hysics Fellow
trookhaven National Laboratory 1961 U. S. Atorsic EnergyUpton, Long Island, N. Y. Commission (AEC) lleal th
Physics Fellow
Ceneral Electrl- Company 1961 - 1963 Ilealth PhysicistKnolle Atomic Power LaboratorySchenectady, H. Y.
Yale University 1963 - 1971 Ilealth PhysicistDept. of University llealth (Responsible for YaleNew Itaven, Ct. University Radintlon
Protection Program)'
Ya':e University 1963 - 1985 1.ecturer !n Public IlealthDe pt . of Epfdemlology and (Environmental llealth)
Public Ilealth *
School of HedicineNew Itaven, Ct.
Yale University 1964 - 1970 Co-Director - GraduateDept. of Epidomlology and .diological llcalth
*
Public Ilealth 11ng ProjectScho,1 of Hedleine '
New ilaven , Ct.
Ya l_e Un iversity 1971 - 1986 Director, llealth Physics.
University Health Services Divisionllew flaven, Ct .
'IE EXPERIENCE - EDUCAT10HAl. |.
) 5 Dest e /Yo a r_ Institution F of Study _
B. A. - 1960 Centre College l'hysic s /Ha thema t le s,
of KentuckyDanvl11e, Ky.
A..H. - 1961 Ilarvard University En gine e r ing /Cambridge , Ha., llealth Physics
EXI'ERIENCE - I'ROFESC10HAl,~
Organlzation Years Position
ilarvard University 1960 - 1961 ,U. S. Atomic Energy,
Cambridge, Ha, Commission (AEC) llealthI'hysles Fellow
f
Brookhaven National 1,aboratory 1961 N. S Atomic Energy.
Upton, 1,ong Island, N. V.'
Commission (AEC) llealthI'hysics Pellow
General Electric Company 1961 - 1963 Ilealth PhysicistKnolls Atomic Power 1,aboratorySchenectady, H. Y.
Tale University 1963 - 1971 Ilealth PhysicistDept. of University llealth (Responsible for Yale .
New Itaven, Ct. Univerelty RadiationProtae.tlon l'rogram)
.
Yale University 1963 - 1985 1.ecturer in Public IlealthDept. of-Epidemiology and (Environmental llealth)
*Pubtle llealthSchool of HedicineNew lieven. Ct.
Yale University 1964 - 1970 Co-Dlrector - GraduateDept. -of Epidemlology and Radiologicai llealth
5. EXPERlENCE W|TH D ADI ATION (Actualvsa ol Radicisatooss or Eavivalant Experience)~
ISOTOPE- MAXIMUM AMOUNT WHERE EXPERIENCE WAS O AINED DtlRATION OF EXPERIENCE _ TYPE oF OSEFionion Knolls Atomic Power Lab.Products Curie levels General Electric Co. Two yearn fuelcar ResearchSNM, TRU ,
Labeled Curie IcVelo Yale University Twenty-four years icientific andCompoundt alomedical.
'
3. Radiop) armaceuticals research
' For past 24 . years inve also taught graduate c aurses in Yale School of Medicinewhich covern all of.the onove items. * *
FORM NRC-313M Suppl / ment A
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,Tranklin Hutchinson
EducationL
:B.S. Massachusetts Institute of Technology, 1942 (phyr'es)~Ph.D Yale = University, 1948 (physics)=
: Research and/or Professional Exoerience
Staff, Radiation Lab, M.I.T., Cambridge, Mass. 1942-1945. Instructor,-Radiology and Physics, Yale University 1948-1951Assistant-Professor, Physics, Yale University 1951-1957Associate Professor,-Biophysics, Yale University 1957-1960Program Director, Departmental Training Grant (NIH) 1958-1985-Professor,-Biophysics, Yale University 1960-Present 1
Acting Chairman, Biophysics, Yale University 1960-1961 1- Chairman,: Molecular Biophysics, Yale University 1963-1963 '
Guggenheim Fellowship,' King's College, London, England 1963-1964Chairman,-Molecular Biophysics,. Yale University 1967-1969
-Chairman, Molecular Biophysics and= Biochemistry, Yale 1973-1976' Director of Undergtaduate Studies, Molecular Biophysics
and Biochemistry, Yale University 1985-Member, Scientific Advisory-Committee, Pacific Norwest
Laboratories (Battelle), Richland, Washington 1985-Member,; Radiation Study Section, NIH 1985-Gordon Research Conference . cut Mutagenesis, Vice Chairman 1986
Chairman 1988
. Prof. Hutchinson =has been the University Radiation Safety .Of ficer and ''twice a past Chairman.of the Radiation Safety Committee. He is a biophysicistand has utilized a wide variety of radioisotopes in his laboratory research.HeLis also the Principal Investigator for a multi-curie Co-60 irradiator-andresponsible for'its radiation safety.-
,;
h, , - - e p- u-- y n ~vN ., n a m n-
., ,
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LOIS E. H1CllOLS* *
PROFESSIO11AL EXPERIENCE *
1983 ' to present s Associate in research in the biology department, YaleUniversity, with Dr. Frank II. Ruddle. Hy work to date hascentered on the gene for the transferrin receptor.
.
1978-1983: Associate in research with Dr. Joseph Gall, also in thebiology department at Yale. During this period I was in-volved in research on the arrangement and expression of
'
Smphibian genes.
1976-1978: Assistant in research in the department of Internalsledicine, Yale University. I worked for Dr. ElliotLivstone on kinetic studies of gastrointestinal tis-sue.
1972-1976 - Assistant in research in the biology department atWesleyan University, Hiddletown, Connecticut. With Dr. S.J.
3erry, I studied the developing oocytes of several icp-idopteran species, to locate stored messenger RNA.
1967-1972: Researcii assistant to Dr. C.J. Hills, also in the biologyCdepartment at Wesleyan university. He studied the muta- 3
-tional load of selected yeast and Drosophila populations.
1963-1965: Research assistant at the Connecticut Agricultural Exper-Ament Station in New Itaven. I worked with Dr. R. Deard todetermine the inheritance of DDT resistance in houseflypopulations.
EDUCATION'
1960 Datchelor of Science degree in Zoology and Entomology fromPennsylvania State University.Elected to Phi-Sigma and Gamma Sigma Delta, Biological andAgricultural Sciences lionorary Fraternities, respectively.
.
Ms. Nichols is the individual responsible for radiation nafety in a majorresearch-laboratory in the University. -She has years of experience in implementingradiation safety in radioisotope research laboratorien utilizing isotopes such as3H, 140, 32p, 35S, 1251.-
Professor of PhysicsAssociate Director, A.W. Wright Nuclear Structure Laboratory
U.S. A. citizen by birth (Dec. 14, 1936)
B.A. - 1958 Amherst CollegePh. D. - 1963 California Institute of Technology
1963 Postdoctoral Fellow - Californial Institute of Technology1963-65 Assistant Physicist - Brookhaven National Laboratory.1965-66 Associate Physicist - Brookhaven National Laboratory1966-70- Assistant Professor - Yale University1970-76- Associate Professor - Yale University1975 Visiting Associate - California Institute of Technology1976- Professor - Yale University
Areas of Specializ: 'o -,
Nuclear Ph; .
Nuclear Astrophysics
,
Prof.-Parker is a nuclear, physicist, is Associate Director, WrightNuclear Structure. Laboratory, and as such is responsibic for the-radiation safety of the tandem Van de Graff accelerator laboratory.The accelerator is operated under a Department of Energy contract andhas been responsible to the Chicago Operations Office. -Prof. Parkerhas worked with a variety of accelerator targets, as well as a wide- variety of sealed sources.
.
e
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I3
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.B.S..
University.of.k'isconsin 1968.M.Phil. (Physics), Yale University
.
1970-Ph.D. .(Nuclear Physics) Yale University: 1975M.D. Yale University School of- Medicine 19771
,
Career-
-7/86-Present Associate Professor, Department of Therapeutic Radiology,Yale University. School of Medicine
7/81 - 6/86 Assistant Professor, Department of Therapeutic Radiology,Yale University School of Medicine
'1/81 - 6/81 Instructor, . Department of Therapeutic RadiologyYale University School of Medicine
Member,-Radiation. Safety Committee, Yale University
Dr. Peschel is a nuclear physicist and an Associate Professor ofTherapeutic Radiology. He has wide experience with nuclear accelerators,therapy accelerators, and-implant sources. -
Acting: General Counsel'and=i- Director of. Federal. Relations
'
JYale_ University (1985-86)L
-Deputy-General Counsel (1984-1986)JAssociate General Counsel (1979-1984)' Assistant Genertal: Counsel-(1978-1979).
LYale University.
-Associate _(1975-1978).Ilughes,-_Ilubbard & Reed
_
~0ne Wall Street-- NewfYork, N.Y. 10005t
Bar-Admissions. .
Admitted 1to practice in Connecticut, California, and New York;U..S. Court of: Appeals,: Second Circuit;-U. S. District Courts for the. Southern District of-New-York and Connecticut; U.-S. Tax Court
~~
Mrs. Robinson'is_the University's legal counsel and Director of. Governmental ~ Relations.
M.S. Wageningen University,llo11and 1 #51Ph.D. Wageningen University, llo11and 1755
Research Fellow, liarvard Univ. 1155-56
GALtnt
1950-52 Research Fellow, Netherlandt OrganizationFor Basic Research
1952-55 Staff Physicist, Laborr.cory For Plant Phyolo-logical Research, Wageningen, Netherlands
1955 Senior Scientific Officer at Large with DutchGovernment
1955-57 Maria Moors Cabot Research Fellow,llarvardUniversity Biologicel Laboratories
1957-61 Biophysicist, John B. Pierce Foundation, New '
llaven, Conn.1961-64 Associate Fellow, John B. Pierce Foundation,
New llaven, Conn.1962-63 Instructor, Department of Physiology, Yale
University School of Medicine1964-68 Assistant Professor, Department of Physiology,
Yale University School of Medicine1964 Fellow, John B. Pierce Foundation1968-69 Assistant Professor of Epidemiology (Environ-
mental Physiology), Yale University Schoolof Medicine
1969 Associate Professor of Epidemiology (Environ-mental Physiology), Yale University School
#of Medicine.Joint appointment at Institution For Social
and Policy Studies1974 Associate Director, John B. Pierce Foundation1975-82 Professor of Epidemiology (Environmental
llealth), Yale University School of Medicine1976-82 Director of Graduate Studies, Department of
Epidemiology and Public llealth1982- Susan D. Bliss professor of Epidemiology
and Public Ilealth, and Chairman, Departmentof Epidemiology and Public 11ealth, YaleUniversity School of Medicine
,
Prof. Stoliwjk is a biophysicist and is currently Chairman of theDepartment of Epidemiology and Public IIcalth. In the past, he was responsibicfor the Nuclear Regulatory Commission license with the Pierce FoundationLaboratories where a broad range of experiments in physiology utilizingradioactive material were conducted. At the Pierce Foundation he wasresponsible for Radiation Safety.
?.
YAl.E UNIVERSITYEW ll AVEN CONN ECTICUT 06 203
(203) 432-4444
Tite PROVOST
December 15, 1987
To: Professor Peter D. ParkerChairman, Radiation Safe ty Commi ttee
hFrom William D. flordhaus i Vprovost of the University
Subject: Radiation Safety: Delegation of Authority
Yale University is issued a license f rom the. United States fluclearRegulatory Commission (NRC) to receive and use radioactive materials in Itnresearch programs. The University has appointed a Radiation Safety Committeeto establish polley and tules governing the use of all types of radiation atYale University including those covered by the liuclear Regulatory Commission.The current chairman of the Radiation Safety Committee is professor Peter D.Parker.
The operational arm of the Radiation Safety Committee is the RadiationSafety Department with Mr. George R. Iloleman, Director. The Radiation SafetyDepartment is responsible for ensuring compliance with the University policlesand rules, and federal regulations; it also provides a broad range oftechnical services to the Yale community necessary for achieving suchcompliance and for promoting a safe working envirotunent.
Mr. Iloleman serves as the Radiation Safety Of ficer. The RadiationSafety Officer is responsible for managing the radiation safety program;identifying radiation safety problems; initiating, responding, and providingcorrective action; verifying implementation of corrective actions; ensuringcompliance with regulations; and is also responsibic for asslating theRadiation Safety Committee in the performance of its duties and serving as itsSecretary.
.
The Radiation Safety Officer is hereby delegated the authoritynecessary to meet those responsib111tles. The Radiation Safety Offlect andmembers of his-professional staff have the authority to immediately terminatea project that is found to be a threat to ijealth, safety or property.
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28 007 1987License No. 03-00183-03Docket No. 030-00582Control No, 107718
This is in reference to renew License No. 06-00183-03. In order to continueour review, we need the following additional information:
1. Concerning your Radiation Safety Committee
a. Please clarify the meeting frequency of your Committee. NRC'sguidance states broad scope licensee's committee should met at leastonce per calendar quarter. "At least four times per year" does notnecessarily equate to at least once per calendar quarter.
b. Please clarify if routine approvals made by the subcommittee arelater given final approval by the full Radiation Safety Committee atits next scheduled meeting. 10 CFR 33.17(b) requires that licensedmaterial may be used by or under the direct supervision ofindividuals approved by th; licensee's radiation safety committee.Please confirm that the requirements of 10 CFR 33.17(b) are met inthat the full committee and gives final approval to all subcommitteeactions.
c, Please clarify the number of members of th? full committee requiredto constitute a quorum,
d. We are returning the curriculum vitae of your committee members.They contain personal information protected by the Privacy Act aswell as lists of publications having no bearing on the individual'straining and experience. Regulatory Guide 10.5 (enclosed)specifically states:
"Do no submit personal information about your individual employeesunless it is necessary. For example, the training and experience orindividuals should be submitted to demonstrate their ability tomanage radiation safety programs. Home addresses and home telephonenumbers should be submitted only if they are part of an emergencyresponse plan. Octes of birth, Social Security numbers, andradiation Ho w information should be submitted only if specificallyrequested by NRC."
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In resubmitting the names of the committee, you should submit informationon each member such as outlined in 10 CFR 33.15(b)(1)(2).
2. Concerning your Radiation Safety Officer
a. Please submit a list of responsibilit|es and duties of your~
Radiation Safety Officer (RS0). The NRC guidance as to duties andresponsibilities of the RSO are listed on pages 13 and 14 of theenclosed guide,
b. Please confirm that the RSO has the authority to immediatelyterminate a' project that is found to be threat to health, safety orproperty.
3. Concerning your Training Program
a. 10 CFR'19.12 requires all individuals working in or frequenting anyportion of a restricted area shall be kept informed of the storage,transfer, or use of. radioactive materials or of radiation in such
portions of the restricted area; shall be instructed in. healthprotection problems associated with exposure to such radioactivematerials or radiation, in precautions or procedures to minimizeexposure, and in the purposes -anc funct. ions of protective devicesemployed; shall be instructed in, and instructed to observe, to theextent within the workeH s control, the applicable provisior ofCommission regu_lations and licenses for the protection of personnelfrom exposures to radiation or radioactive materials occurring insuch areas; shall be instructed of their responsibility to reportpromptly to the licensee any condition which may lead to or cause a-violation of Commission regulation and licenses or' unnecessaryexposure to radiation or to_ radioactive material; shall be instructedin the appropriate response to warnings made in the event of any.unusual occurrence or malfunction that may involve exposure toradiation or radioactive material; and shall be advised as to theradiation exposure reports which workers may request pursuant toS-19.13. The extent of these instructions shall be commensuratewith potential radiological health' protection problems in therestricted area.
In light of the instruction that shall be given these individuals, pleaseamerd Item 8., paragraph 1, line 6, sentence starting "The individualshould .. ..." to "The-individual shall ...." in order that it conforms'with the requirements for attendance as stated on your application for-the use of_ radioisotopes, Item 4, and under Specific PrincipalInvestigators Responsibilities, Number 2;
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b. Please confirm that instruction is given both initially upon hiringand_ annually thereafter as refresher training for all radiationworkers and ancillary personnel.
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4. Regarding Individual User Responsibility
a. Item 4.b. of Individual User Responsibility requires the wearing ofrubber gloves when working with radioactive meter. Please clarify ifrubber includes any non porous protective gloves, e.g. latex,polyvinyl or polyethylene,
b. Item 4.e. requires use of automatic or remote pipettes, Please amendthis responsibility to include " Pipetting by mouth is forbidden."
c. Please amend Item 5. responsibility to include application ofcosmetics, e.g., " Eating, drinking, smoking and/or application ofcosmetics in areas where radioactive .... "
5. Regarding Periodic Surveys of Radiation Area)
a. Please define " periodic"
b. Please submit the criteria the committee uses in assigning thefrequency of radiation surveys in each area using radioactivematerials for which the individual user or principal investigator isresponsible. Please clarify if these surveys are recorded.
6. Regarding Radioactiv' Contamination of Areas
a. Please define 100 counts per minute above background.
b. Please redefine your acceptable contamination levels in terms of dpmas required by 10 CFR 20.5.
7. Regarding your safe opening procedures for radioactive materials packages
a. 10 CFR 20.205(d) requires safe opening procedures be established forall packages. Therefore, your safe opening procedures cannot be justrecommendations. Please delete the word recommended from theserequired safe opening procedures,
b. Please clarify where packages are received at your campus,
c. Please clarify if the Radiation Safety Office is involved in safelyopening packages,
d. Please amend procedure 3 under ojening to include a survey at 1meter from the surface and at the surface of the package. Recordthe results.
e. Suggesting gloves be worn when opening should be changed torequiring gloves be worn.
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f. Please amend procedure to include-requirements in 10 CFR 20.203(f)(4)for defacing empty uncontaminated packages prior to placing them inunrestricted ~ areas. ~
g. Please submit your proce:Jres for receiving materials duringoff-duty _ hours. Secur_ity personnel, or anyone else receivingpackages during off-duty hours, should be given written instructionsfor receiving, examining, and securing the package, for notification i
procedures, if the package is found or suspected to be leaking, andfor immediate steps to be taken to prevent spread of contamination.
h. Your procedures for open'ng packcges should include instructions to-notify the-Radiation Safety Officer if radiation levels exceed 200mr/hr or 10 mr/hr at the su-face or at 1 meter, if a Yellow IIIlabeled package or at other Nvels for Yellow II and White DOTlabels. Please submit amend'' procedures.
8. Regarding Additional Elements.of the Program
a. .Please amend the res; 1sibilities of principal investigators (PI) inItem 5;e., line 4, P.I. should submit .. .. Inventory dcta in a
,
quarterly basis to shall submit in order to comply with inyt 9 eryrequirement. "An isotope inventory is compiled by the RadiationSafety Ocpartment each quarter."
>
b. In support of your request for 500 millicuries of phosphorus-32, youshould-develop and submit special safety instructions to be provided'to individuals'using millicurie quantities of P-32. We recomendthat your procedures include, but not be limited to, the following;
1) The use of low density shielding (e.g., Plexiglas)-in order tokeep Bremsstrahlung radiation at a minimum,
i 2) A mandatory radiation survey and wipe test procedure af ter eachuse.
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3) The use of finger type extremity monitors for procedures that,
L involve-1 millicurie or more,
L 4) The use of a dry run's lor to the performance of unfamiliarprocedures in order to preclude unexpected complications. In'
addition, it is recommended that the radiation protection| of.fi:er be present during new procedures.
5) The use of eye protection for procedures that involve 10-millicuries or more.
Please submit your procedures fr .:,e of P-32.
OFFICIAL RECORD COPY ML 164 JOHANSEN - 0004.0.010/23/87
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c. Please clarify who performs hazard evaluations regularly.i'
d. Please clarify who performs contamination surveys quarterly. Whereare records maintained?
e. Please clarify who perform leak tests on sealed sources in excess of100 microcuries beta gamma or 10 microcuries alpha. Your statementof a 1 millicurie limit for leak testing sealed sources isunacceptable.
- 9. Regarding personnel dosimet.y ,
1
a. Please specify frequency of es-bre.ge of film badges and TLDs,
b. Please specify when thyrcid monitoring would not be specifiedsubsequent to iodination with 1 millicurie or more of Iodine 125 or131.
10. Regarding Corcrol of Student Exposure
a. Plesse confirm that undergraduate use of radioactive material willbe under the supervision and in the physical presence of aninstructor approved by the Radiation Safety Committee.
11. Regarding Instrument Calibration
a, Please clarify'if you still intend to calibrate survey instrumentsfor individuals and institutions with associations or af filiationswith Yale University,
b. If you calibrate survey instruments for medical licensees, pleasesubmit a copy of the certificate of calibration showing compliancewith 10 CFR .35.51(d)(1)(2).
12. Regarding Waste Management and Procedures
a. Please justify paragraphs 1, 2 and 3 under 1. Solid Waste. Currentlicense _ conditions allows decay-in-storage of nuclides with' half-lives (th's) of 65 days or less. This condition requireswaste be held 10 t 's prior to survey with appropriate survey meterto assure activity in waste cannot be distinguished frombackground. As such, 300 day th nuclides have to be held ~ 10 yearsand 100 day th nuclides for 3.25 years. Such methodology mayrequire you to have a low-level waste storage license.
b. Please clarify if you are requesting an increase in the half-lif of-
the nuclides held for decay in storage from 65 days to 100 days.
! 0FFICIAL RECORD COPY ML 164 JOHANSEN - 0005.0.0| 10/23/87
- . _ _ - _
- o o.
6
c. Please clarify if paragraph I under 3. Gaseous Waste refers to 10CFR 20.106.
13. Please submit your administrative prncedures for control of procurementand use of radioactive material. (i.e., who controls procurement andhow, and a list of rules for safe use of radioactive materials in thelaboratory).
14. Please amend your procedures for control of aerosols, dusts, and gaseousproducts to state shall be conducted in a hood, glove box or othersuitable closed system. Shoul_d implies recommendation, shall indicatesa requirement for usage.
Please note that recommendations, suggested rules and procedures and the use ofshould in procedures does not show the establishment of appropriateadministrative procedures as outlined in 10 CFR 33.13(c)(3).
'
i We will continue our review upon receipt of this information. Please reply indupjicate to my attention at the Region I office and refer to Ma:1 Control _
No. 107718.
In order to continue prompt review of your application, we request that yousubmit your response to this letter within 30 calendar days from the date ofthis letter.
Sincerely,
Origirm1 Signet 1 D6Jenny M. Johazz3eu
Jenny M. Johansen, M.S.Nuclear Materials Safety Section BDivision of Radiation Safety
and Safeguards
Enclosures:1. 10 CFR Parts 19, 20 and 332. Regulatory Guice 10.53. Radiation Safety Committee Members Curriculum Vital
RI:DRSSJohansen/mjh
10/%/80FFICIAL RECORD COPY ML 164 JOHANSEN - 0006.0.0
10/23/87
_. _ _ - _ _ _ _ _ _ _ _ _ _ _ _
- - . -
| p Katoq UNITED STATES# h, (>9 CLEAR REGULATORY COMMISSION ([, t d REGION I (
l L j 631 PARK AVENUEI t I KINO or rausst A. PENNsYLV ANI A 19404
....*
15 SEP B87
Yale University '
ATTH: Dr. Peter D. Parker, ChairmanRadiation Safety Committee
314 Wright Nuclear Structure Lab., West"
b20 Docket No. 030-00582H n C
License No. 06-00183-03
Control No. 107718
SUBJECT: LICENSE RENEWAL APPLICATION
Gentlemen:
This is to acknowledge receipt of your application for renewal of the material (s)license ident9fied above. Your application is deemed timely filed, and accordingly,the license will not expire until final action has been taken by this office.
Any correspondence regc.rding the renewal application should reference the controlnumber specified and yaur license number.
Sincerely.
Original Sinned ByfDoris J. Foster
John E. Glenn, Ph.D., ChiefNuclear Materials Safety Section BDivision of Radiation Safety and
September 15, 1987 Dm L;i.. . .~ ~'7 - - - -' I' UD - - - M.
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Dr. John E. Glenn' '
Materials Licensing Branch a
Division of Fuel Cycle and Material SafetyU. S. Nuclear Regulatory Commission v
631 Park AvenueKing of Prussia, Pa. 19406
Dear Dr. Glenn:
Subject: Amendment to our Present License No. 06-00183-03with expiration date of September 30, 1987:Ref.: Miles Laboratories, Inc.
It has come to our attention that the Miles Laboratories, Inc., whichhas a laboratory in the Osborne Memorial Laboratories at Yale University, willnot vacate the premises until the expiration of their lease on December 31,1987. Therefore, we request an amendment to our present license to extendpermission for Miles Laboratories, Inc. to continue the purchase and use ofradioactive materials on the Yale University premises noted above untilDecember 31, 1987. This involves the continuation of Conditions 10 and 12 ofAmendment No. 50, dated April 24, 1985 (copy enclosed).
Please find enclosed a check in the sum of $120.00 from MilesLaboratories, Inc. made out to the United States Nuclear Regulatory Commissionto cover the fee for this amendment.
You may contact me at 203/432-3090 if there are questions.. . .
,/ fery tru19 ours, '),-
C _WkPeter D. Parker, Ph.D.Chairman, Yale UniversityRadiation Safety Committee
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U.S. NUCLEAR REGULATCnY COMMISstON j g 7f NRC Form 374 AInh.@4 ucense numter** - . .
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i M ATERI ALS u INSE 6..00183.03_**
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y 314 Wright Nuclear Structure|<4 Laboratory West I
( 260 Whitney AvenueT:i New Haven, Connecticut 06520 ,P
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[ In accordance with letter dated March 15, 1985 License Number 06-00183-03 is ;
i amended as follows: {pp.
iD-j ltems 6, 7, 8, and 9 are amended to read: , ,
P![%[,j 6. Byproduct, source, and/or 7. Chemical and/or physical 8. Maximum amount that
licensee may possessy special nuclear material ,yform .
' at any one time p
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2 s'"s 'under this license p,t *
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A. 500 millicuries each pp: A. Any byproduct material T.'' A. Any
' nuclide - Total 50 Fd between Atomic Numbers 3 "' N ks
3 and 84, inclusive ..'1 'b 'A -e curies~ :,-c - B. 200 curles f| B. Hydrogen 3 ," / B.'Any N . . . .
C. Any .: C. 35 curies p) C. Sulfur 35 '
" 0. Metallic wire t ,P ,' O. 2 curies p}_.
..
i D. Cobalt 60( E. Copper 64 s E . - Any * x _:: z u_. : c:p E 25 curies pj'
.
f] F. Strontium 90 ." F. Sealed Source . . 6: F. 600 millicuries F;,
.G. Cesium 137 ..;) G. Sealed Source- .- ' G. 12 curies R1
!"E'' ' ' H. 115 millicuriesH. Thorium 228 Hi'Any
$ I. Neptunium 239 '';> 'I."Any H ~., 1 5, J I. 1 millicurie hj--"x J. 25 millicuries p
i J. Americium 241 J. Any~i K. Americium 241 K.-Am-Be Sealed Source . K. 300 millicuries I'n'I
& L. Californium 252 , L. Any W!; ,T 4/ L. 3.5 millicurles D'
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NRC Feem 374A U.S. NUCLE An REGULATORY COMMISSION ,,gg 7 g, p,,qQ_ tij .fJ k. Lkense number - :. , . -
[,5MATERIAll ENSE L 06-00183.03'
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! SUPPLEMENTA SHEET b'
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8 AmendmenLRado ;Fh. ,? p
|h;| Conditions 10, 12, and 21 are amended to read:> b
3 10. Byproduct material may only be used on premises possessed by, or under the direct .pli control of Yale University, New Haven, Connecticut; at the Connecticut Mental Health |bff Center, 34 Park Street, New Haven, Connecticut and at Miles Institute for Preclinical th| Pharmacology housed at Yale University, Osborn Laboratory,165 Prospect Street, New J[pj Haven Connecticut. |p;15 'p;,
! -12. Byproduct material shall be used by, or under the supervision of, individuals p;
i designated by the-University Radiation Safety, Committee, Peter D. Parker, Ph.D., .D[Chairman. The Radiation Safety Committee may approve individuals from outside the E
?| University to be authorized as Pr.incipal Investigators under the Yale L.icense to use 4
h;.i radioactive materials on Yale University premises provided the individual'si background and training ar,e appropriate. .s pg s. ~ p. _
-
il 21. Except as'specifically'jifovided otherwise by this license, the licensee shall possess p;
$ and use licensed material' described in Items 6, 7, and 8 of this license in accordance <ltd with statements, repre'sentations, and procedures contained in application dated 'h[| May 15, 1979, [/,;' , 'includi' g manual of Radiation Safety Procedures dated July,1977; andn
i letters dated May 20, 1982, Se'ptember 7,"1982, March 14, 1983, September 28, 1984, g
) and March 15, 1985.' The -Nuclear Regulatory Coninission's regulations shall govern the yf licensee's statemerits in applications,ot_ letters, unless the statements are more b
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y Nuclear Materials Safety and fSafeguards Branch, Region I fKing of Prussia, Pennsylvania 19406- -
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BEThEEN:C." James Hollowa , Chief- I / - [,C l- /License Fee _ Management Branch ,
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Office-of Resource Managementw |
- iJohn E. Glenn.- Chief- - .
WT INuclear Materials Safety,& Safeguards Section B"Division of Radiation Safety and Safeguards
NI4ctAAAJL d. 1
LICENSE FEE TRANSMITTAL
REGION [-'A.-
1. APPLICATION ATTACHED
Applicant / Licensee: Yale University (MilesLaboratories,Inc)
Application Dated: September 15, 1987
07637Control No.:- 0183-03
License No.: _,h n,
2. ' FEE ATTACHED
Amount: 120 hp |2505381
No,
' 3. COMMENTS ,-
could "ct-find-file
\ PSigned
Date
B.. LICENSE FEE MANAGEMENT BRANCH-
1. Fee Category and. Amount: e Y 3 044- 8CMM Y6 /sk2. Correct Fee Paid. Appl.ication be processed for: ,
Amendment N~ ~
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(O |lof(/Date __
REGION.1 FORM 213-(MARCH 1987)
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_ OCONVERSON RECORD ! ""' |''"' 9//p7
0 V! Sit O CONFERENCE O TELEPHONE """ #"*, '" I
O INCOMINGLo.ation of Visit / Conference: O OUTOOING
I NAMC OF PLRSON(C) CONTACTED OR IN CONT ACT i ORGANil AtlON (Offg a, dept., bureau, Tf ttPHONI NO' l'. | etc ) L/ A& kuu, , e///3 -
I ) f A. W. WRIGHT NUCLEAR STRUCTURE LABORATORY,i P.O. Bm 6666. 272 Whitne) Avenue, New Haven Connecticut 06511 Q
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Dr. John E. Glenn. 3~ Materials Licensing Branch.
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Division of Fuel Cycle and Material SafetyUnited States Nuclear Regulatory Commission~631 Park Avenue;
King of Prussia, Pa. 19406f
; Dear.Dr. Glenn:
Subject: Renewal of Nuclear Regulatory Commission (NRC)-License No. 06-00183-03- Yale University
Enclosed is the Yale University renewal for Broad License No. 06-00183-03..
.There are:no major. changes in the program from the past. and we have tried toinclude all pertinent information in thisLapplication. We would appreciateremoval of.the tie-down clause in the present license-referring to pastcorrespondence.- In many-cases, the-correspondence is old and obsolete.
If there are: questions,-please phone.me at 203/432-3090, orGeorge Holeman at-203/432-3040. f- - - ,
. , -Very~,truly y urs,
!
/
) / ~.? &R_Peter D. Par'ker, ChaTrman. Radiation Safety Committee
PDP:cmEnclosures
L!CC."40FCC||.kmG!!CR
cc: George R..Holeman 00 (g[ b,[ @ ~
/077f4 -William Stempel ![
"0WKRECORCOU" % 20 AUG 1987. . . . . . . .. .
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NRC F07.M'313 [ '' * ~ U.S. NUCLE AM REGUL Af 0MY COMMISSIONAPPfiOVED BY OMS
LIBl I S16601to
3S ad 4o = A LICATION FOR MATERIAL LICENSE' in** S Si ff10 CF R 30,31,33,34,
INSTRUCilONS: SEE fHE APPROPRIATE LICENSE APPLICAllON OUIDE FOR DE T AILED INSTRUCTIONS FOR COMPLEilNG APPLICAllON. SEND TWC COPIESOF THE ENilRE COMPLEIEO APPLICAllON TO THE NRC OFFICE SPECIFIED BELOW.
FtOET.AL AOtNCitS fill APPLICAtlONS Wlf Hi . OF YOU ARE LOCAI80 IN-
IL LINOIS, INDI AN A, LOW A, MICHIC AN, MINNtSOT A, MISSOUlli, OHSO, ORU SI WUCLf AR RIOULATORY COMMIS3 ION 'DIVISION OF FUEL CYCLt AND MAT ERIAL SAFETY NMSS
WISCONSIN, SE ND APPtlC AtlONS 10:
WASHINGTON, DC 20566 U.S NUCLE AR Rf *'LATORY COMMISSION, RtOION HIAtt of MER PERSONS fitt APPLICAflONS AS FOttOWS,17 YOU ARE MATERIALS LICt ING SEC flON
799 ROOstVELT hsADL OCA f f D IN r OLEN ELLYN,ll 80137CONNECTICUf, D$tAWARE , DISTRICT OF COLUM80A. MAINE, MARYtAND, ARK ANSAS. COLOR ADO,10AHO, K ANSAS. LOUISL AN A. MONT AN A, Nt0R ASK A,MIS?iCHUSEff S, NEW HAMPSHillt, NEW JERSEY, NEW YOflK, PENNEYtVANIA,
OR WYOMINd, NORTH OAKOf A, OKLAHOMA, SOUTH DAKOf A,1SXAS.UT AH,Ntw MEXICOM:006 ISLAND, OR VERMONT, SENO APPLICAllONS 70- SEND APPtlCA110NS T0:U S. NUCLE AR RtOut A10A Y COMMISSION, REOtON 1
U S. NUCLE AR REGUL ATORY COMM1SftlON REGION IVNUCLE AR MAf ERI AL SECTION D MAf f RIAL RApl A110rl PROTICTION $tCTION$18 PARK AVENUt $11 I Y AN PLAI A DRIVE. SUITE 1000. KING OF PRUSSIA,PA 194015
- - ARtlNO T ON, T M 76011AL A01MA. F LORIDA, OtORot A. K E N TUCK Y, MIS $1981PPl, NOR T H C A ROLIN A, AL ASK A ARl20N A, C AtlFORNI A, H AWAlf. NEV ADA, ORIOON, W ASHINQlON,
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PUt3f D RICO. SOJf H CAROLINA, T ENNES$t t, VIRGINI A. VIRGIN IS( ANOS, OR AND U.S,itflRIIORIES AND POSStsstONS IN THE PACIFIC,SENO APPticAflONSFvESI VlRQ1NIA,SENO APPtiCAtlONS TO 70:
U S NUCLE AR Rt0ULATORY COMMIS$lON RiolON il U S NUCLE AR REGUL ATORY COMMISSION RE GION V' MAf tRI AL RAplAllOM PROF f CilON SECilONMATERIAL RADI AflON Pelof(Cf DON SEC110N101 MARitii A STREti, Sulf f 7900 1450 MARIA L ANE,8Ulf f 210. AfLANf A,0A 3032) - WALNUT CRttK,CA 94596
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Ft R$0NS LOCATED IN AQfittMENT ST ATES SIND APPLICAflONS TO THE U.S. NUCLE AR REOULAIORY COMMISSION ONLY IF THf Y WISH TO POSSISS AND USE LICENSED MAf f RIALIN ST AT ES SU6 JECT TO U.S. NUCLE AR RE GUL A TORY COMMIS$10N JURISO1CilON.
1 THis IS AN APPLICATION FOR (Cheet approprseas seem) .1. NAME AND M AILING ADORtSS OF APPLICAN f flarevde 4 Cede)- Yale UniversityA, NiW uCeNSE~~
e 'AuenOMENi v0 tictNst NUM.iR _ 314 Wright Nuclear Structure Lab., West~ 06-00183-03 26C Whitney Avenue7 C.etN WAt OF uCENSI NUue R
- New Haven, Ct. 065203. ADDRESSIESIYtHERI LICENSED MAiERIAL WILL SE OSEO OR POSSESSED.
.
See attached
( NAun OP PenSON tO se CON T ACf sD AsOUf vHiS APulCAflON Physica Dept. 27 2 Whitney Avp{LIPHONE NUM9EflDr. Peter D. Parker, Yale University New Haven, Ct. 06520 203/432-3090
SUOMff if f MS S THROUGH 11 ON S'4 s It'' PAPIR THE TYPE AND SCOPE OF INFOnMAllON (C Pt PROVIDED 15 DESCRI6ED IN THE LIC6NSE APPtlCAflON 0Ut08.
9. RADIOACTivf FATERIAL- e tiement end e sse manher, it enemicol oad/or phvecelle m, ead e, meomum amoual 8 PURPOSRISI FOR WHICH (ICENSf 0 MATE RI A( WILL $$ USED.
which will be pos med al eaY one time
f. INDIVIOUA 5 E PO S $L FOR R AOIATION SAP t f Y PROGRAM ANO THEIR 8 TR AINING FOR INOlvlOVALS WORKING IN OR FREOUCNilNO RESfRICIED ARG AS.
9. F ACILifitS AND $OUIPMENT, to. RADIATION S AF$ f Y PROGR Au
l: L,CENsu nES esse so Cn vo n a s-r.*~ oon'
Fit CAttoOagRgrt 70.1%&TS60 sNONE/ EXEMPTei, WA$f f MAN AotutNT.
13. CERilF IC A flON, fa#vst be gempsefed&P epphredf/ IHf APPt| CANT UNDERST ANDS THAT ALL ET AT EMENIS ANO REPRESENI AflONS MAOf IN THIS APPLICAllON ARE
BINDING UPON THf APPVCANT%
THE APPCTC~ ANT E3MSN, OFFICIAL EXFCU ING THft CtRflFIC AflON ON SEH A(F OF 1HE APPLICANf,NAMEDIN ITIM 2.CERilFY THAT THit APPLICAflON MPFIE P AntO IN CONFORMI Y Wif H ilitt 10, Of OF F EOGR AL Rf oulA f TONS.P ARTS 10.32 33,34. 39 AND 40 ANO THAT ALL INFORMA flON CONT AINED HERilN,
c83TRUt/ OCOnnEC O f ME BEST OF TH 1 KNOWLEDGE AN0 0ElitF,7
. WARNffv0.18 U S# (CTION 1001 ACT OF UNE 26.194S 62 $1 Af 149 M AKES IT A CfDMIN AL OFFENSE to MAKE A WILLFUL (Y F ALSE ST ATEMENT OR REPRISENT A f1ON*
10 ANY ostpriktNT OR AGtNC it UNIf tD ST AfiS AS TO ANY MAT TtR Wif MIN 115 JURISDICTION
SioN Af tpr~CtRilF YING OF FIC f YPEO/PRINitD NAME . fif LE Cha1[ man OAlt'
Peter D. Parker, PhD. Radiation Safety Committee 8/10/87g ;- I4. YCLUN f A R Y ' CONOutC D A F A
e A Pt U LL R Cf t* f t th NUMilE R OF E MI'LO Y E E S f rere' #or it WOULO YOU III WILLING f 0 7UHfilSH COs t INF'OHMA llON Qoner noever ges#f Poves)enh's feedeft e.chs8mf evtue sentre<fers/ ON THE ICONOMIC IMPACT OF CURRENT NRC REGULATIONS Off ANY FUTURE
< S MOK - SIM-3 SM PROPOSED NRC REGULAflONS THAT MAY AFFECT YOUP fNMC reFeslersees perrmt"***'***********#***'**'*'"****H"**'W"***** " ' *
$1SM-fM Ihe openey in tenturenrel-
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Item 3: Loca* ion of-Use-
Radioactive material will be used on the Yale University campus or otherlocations under the direct control of Yale University. In addition, materialwill be used at- the Connecticut Mental Health Center, 34 Park Street, NewHaven, Connecticut. The Connecticut Mental Health Center is adincent to theYale Medical School and-is staf fed by Medical School personnel. If materialis to be used for off-campus work or environmental experiments, special
R. Curium 248 R. Electroplated target R. 4 microcuries
S. Protactinium 234 S. Any S. 1 millicurie
T. Actinium 227 T. Any T. 1 millicuric
U. Cesium 137 U. Scaled Sources (ICN U. 8 curies, 2 sources
Model 76007, formerly of 4 curies each
U.S. Nuclear Model 375)
V.- Protactinium 233 V. Any V. 1 millicurie
W. Americium 241 W. Scaled Sources (Camma W. 13 curies, no source
Industries Model VD) to exceed 2 curies
Any byproduct material Any quantity of each less
with Atomic Number greater than 100 times thethan 84 10 CFR 20, Appendix C
Limits
.
O O..
Item 6: . Authorized use
Research and development as defined in 30.4 (q) of 10 CFR Part 30.
Item 7: Individuals Responsible for Program
Four stages of responsibilities are involved in the Yale Universityradiation sa fety program. All are equally important:
1. ' Radiation Sa fe ty Commi t te e : This is a group of scientists,physicians, and other experts and technicians appointed by Yale
University to establish policies and regulations governing theuse of all types of radiation at Yale University.
2. Radiation Sa fe ty Department : An operating unit of speciallytrained health physiciste and technicians which is responsiblefor ensuring compliance with these policies and regulations; italso provides a variety of technical services to the Yalecommunity necessary for achieving such compliance.
3.- - Authorized Principal Investigators : University faculty members
whose training and experience are such that they have been- authorized by the Radiation Safety Committee to use ionizingradiation in their laboratory's research activities. ThePrincipal Investigators are responsible for their laboratory'sradiation safety compliance.
4. Individual Users: Sc9at is ts , physicians , other pro f essionale ,students, research personnal, technical and other workersengaged in laboratory research and research support activitieswhich involve actual use and handling of materials and devicesproducing radiation. These personnel usually work under theimmediate supervision of authorized Principal Investigators.
'R ADI ATION ' S AFETY COMMITTEE
The University Radiation Sa fety Committee has been appointed by theProvost of Yale University and is charged with responsibility for allradiation safety problems which may arise within the University. Among itsduties is supervision of the use of radioactive materials as requirec byNuclear Reguatory Commission licensing regulations. The Committee hasauthority to grant, deny or withdraw permission for the use of isotopes or -
any other radiation soitree within the Univeroity. It is the intent of theUniversity that -no use of radiation proceed without the knowledge andapproval of the Radiation Safety Committee. The Committee is expected tobe responsible for advising the Provost arcl other members of theadministration.
Full Committee meetings are scheduled as needed, and generally at leastfour times a year, to determine overall policy and act on speci ficproblems.- A sub-committee, chosen by the Chairman of the UniversityRadiation Sa fety Commit tee, consults frequently and approven applicationfor the routine uses of radioactive materials. Approval is based onconsideration of the training and experience of the investigator, thefacilities at his disposal, the protocol, and the degree -of hazard of theproposed experiments.
The sub-committee to review proposals for the use of isotopes circulatesthe isotope authorizations for review. The subcommittee presently
/ consists of Peter D. Parker, George R. Holeman, and either Frederick W.Greenhalgh or Kenneth W. Price. The expertise of the sub-committeemembers is as follows:
1. Peter D. Parker, Nuclear Physicist, Professor ofPhysics, Associate Director, Wright Nuclear StructureLaboratory, and Chairman, University Radiation Sa fetyCommittee. Dr. Parker has had radiation protectionexperience with a wide variety of accelerator producedisotopes as well as a large number of scaled gammasources used in his laboratory.,
2. George k. Holeman, Director Health Physics Division, andLecturer in Public Health, is a certified HealthPhysicist and has had wide experience in radiationsafety associated with fission products at BrookhavenNational Laboratory, Knolls Atomic Eower Laboratory, andin radioisotope research at Yale University. .
3. Kenneth W. Price, Certified Health Physicist, Deputy.
Director of the Health Physics Division, and Lecturer inPublic Health, has had experience in radiation 3protection associated with nuclear weapons testing in i
'Neva la as well as extensive experience in radiationprotection ur 'er a broad research license utilizingradionuclides in research.
4 Frederick W. Greenhalgh, Health Physicist, has hadextensive experience with labeled compounds andlaboratory safety associated with research programs at
.
the University of Connecticut Health Center, and at YaleUniversity.
,
Additional information on the. review and approval process is given in Item 10.o
-Chairman: Peter D. Parker, Ph.D., Professor of Physics
Secretary: George R. Holeman , Director, Radiation Safety DepartmcatActing Asso late Directer, Departmentof Occupational and Environmental ,
Health and Safety
' Members: Alexander Gottschalk, M.D. Professor of D* agnostic Imaging(Nuclear Medicine)
Franklin Hutchinson, Ph.D. Professor of Molecular Biophysics andBiochemistry
Deborah McGregor, M.D. Direc tor Department of Occupationaland Environmental Health and Sa fety
Lois-Nichols Associate in Research, Department of .sBiology
Dorothy K. Robinson General CounselJan A. Stolwijk, Ph.D. Professor of Epidemiology
Chairman, Department of Epidemiologyand Public Health
_ Curricula Vitae attached
ERADIATION S AFETY DEPARTMENT
Director (CHP) George R. Holeman Part TimeHealth Physicist and Deputy Director (CHP) Kenneth Price Full TimeHealth Physicist-(ABHP-Board Eligible) Frederick Greenhalgh Full Time
= Health Physicist ( ABHP-Board Eligible) June Tamkin Full TimeAssistant to Director Claire Mulvanev Full TimeAdmin'istrative Ass is tant Lorraine Venditto Part TimeDepartment. Secretary Andrea Beady Full Timei Chief Technician
- G3orge Andrews Full TimeHealth Physics Technician'(Monitoring) Paul Dinnean Full Time
LHealth Physics Technician (Monitoring) Leonard Grabowski Full Time
!
Health Physics Technician (Waste Managemenc) Larry Easterling Full T{meHealth Physics Technician (Waste Management) Louis Gurske Full TimePersonnel Monitoring Specialist Rebecca Wayne Full Time
The authorized Principal Investigator is responsible for training theindividuals working in his or her laboratory. The Radiation Sa fety Departmentassists the Principal Investigator by providing routine seminar sessions onradiation safety and protection techniques shortly thereaf ter. IndividualPrincipal Investigators train individual workers in spect ris Sboratory safetyprior to beginning work. The individual should then shortly therea f ter attenda radiation safety seminar presented by the Radiation Safety Departtnent. NewPrincipal Investigators attend Radiation Safety Department Seminars to becomeacquainted with the Yale University procedures.
10CFR Part 19 requires that each individual worker entering a restrictedarea be provided information on the radiation hazards to be experienced,biological ef fects of radiation and techniques of radiation protection. Thecontent of the instructions chould be appropriate for the level of involvementwith radloactive materials and radiological health protection problems in ti.eraJtricted area. The monthly radiation safety seminars presented by theRadiation Safety Department sta f f cover the required material in 10 CFR ? art19 as woll as institution- specific information. The seminars are listed in
'the Yale Weekly Calendar of Events and are always open to anyone in the YaleCommunity who may wish to attend including ancillary personnel. Spect fic
'
radiation workers identified by the Radiation Safety Department are contacteddirectly concerning seminar attet dance.
In addition, special seminars or training emphasizing safety aspects of aparticular radioisotope or experimental technique are given upon request togroups within the University. Radiation gafety education anu training arecontinuously provided during routine surveys, hazard evaluations, emergencyresponse activities, and daily information requests. The Radiation Sa fe tyDepartment furnishes consulting, tra in ing , and educational services toancillary supervisory or training personnel. More speci fically, specialradiation safety lectures and visual aids are given to ancillary supervisorypersonnel such as Traf fic, Receiving, and Stores, Custodial Services GroundsMaintenance, etc. , who convey this information to their subordinates.Security personnel have rece sved instructions in the event of any incident or ,
emergency involving radioactive materials. Also, the Fire Marshal's s ta f f hasbeen instructed in certain radiation safety procedures which are pertinent toits function.
Radiation Sa fe ty Department survey technicians receive training In surveytechniques by the Radiation Sa fety Department. Radiation Sa fety Departmentwaste technicians are continually trained and updated on current site criteriaand shipping procedures for radioactive waste. The Personnel MoaltoringSpecialist undergoes extensive training in radiation safety in fo rma t ion .
The following list has examples of typical University laboratory personnel-who participate tn licensed activities and who receive, possess, use, ottransfer material licensed by the Nuclear Regulatory Commission as detailed in10 CFR Part 19:
Principal InvestigatorsFaculty members, scientists, and physiciansPost-doc toral fellowsStudents (graduate and undergraduate)Research technicians'
Radiation Safety technicians (n.onitoring and warte)Classware/dishwashing technicians 1
Animal Care
Ancillary University personnel who typically receive Radiation Sa fetyDepartment training are:
Traf fic, Receiving, and StoresYale l niva.rsley Police, Security Guards, Fire MarshalPhysical Plant
Grounds Maintenance (selected groups within)Construc tion Management ServicesDepartmental Business managersCustodial ServicesSecretaries / Clerical workers
Training involves slide presentations, visual aids, question and answersessions led by professional Radiation Safety Denartment personnel, attendanceracords , written inst ructions and guidelines , and information handouts.
The primary use of isotopes at Yale University is in support of its largebiomedical research programs. Two areas are the primary users:
a) The Medical Center composed of a Medical School, Yale-NewHaven Hospital (NRC License No. 06-00819-03) the PierceFoundation- (NRC License No. 06-02354-02), a Nursing School .a School of Public Health, and the Connecticut Hental HealthCenter, and is af filiated with the Veterans AdministrationMedical Center in West Haven (NRC License No. 06-00092-05)
and
b) the Faculty of Arts and Sciences composed of the maior basicscience departments such as Physics, Chemistry, Biology,Geology, Engineering and Molecular Biophysics andBlochemistry. Also includes is a Department of
Energy-supported accelerator laboratory.
In'both areas, the bulk of the isotopes are used in standardbiochemical-tyre laboratories.
Larger quantitles of isotopes are used in central facilities operated andsupervi.ed by the Radiation Safety Department. These central facilitiescontain stainless steel hoods, sinks and benches. The hoods are filteredwith combinations of filters including HEPA type and/or charcol . Air
sampling provisions are designed into these facilities. Larger stocksolutions are stored in the central f acility and dispensed when needed by -the Radiation Safety Department. These central facilities are underRadiation Safety Department control and are secured when not occupied andhave limited key circulation. A number of satellite f acilities are beingused for 1251 in routine iodinations. Eleven such facilities are inactive use. These iodination facilities are primarily glove boxes withcharcoal filters and provisions for room air and exhaust air (both pre-and post-filter) sampling. These satellite f acilities are supervised byassigned Principal Investigators.
The isotopes in a general laboratory are usually stored in refrigerator /freezers. They are located in the laboratories which are generallyoccupied 24 hours a da' . When unoccupied during off-hours theylaboratories are secured. During of f-hours, all campus buildings arelocked. During normal working hours, all Medical Center buildings arelocked with guards at _ all open entrances screening personnel foridentification badges. Unauthorized individuals are not admitted.
Figure 1 Medical Center Radioisotope Facility, I-248 Sterling flallof Medicine. Supervised by Radiation Safety Departmentpe r s onne l . Used by Principal Investigators for high-level
! or hazardous quantity experiments.
Figure 2 Medical Center Radioisotope Facility, 400 Laboratory for.
Epidemiology and Public llealth. Supervised by Radiationj Safety Department personnel. Used by Principal
Investigators for high-level or hazardous quantity'
experiments.
Figure 3 Science Area Radioisotope Facility, 1138 Kline Biology'
Tower. Supetvised by Radiation Safety Departmentpersonnel. Used by Frincipal Investigators for high-levelor hazardous quantity experiments.
Figure 4 iudicci Center Waste Storage Area, BC-85A Sterling Hall ofMedicine. Used by Radiation Safety Department personnel tostore isotopes for decay, compaction; to store frozenanimals and process waste from the Medical Center.
Figure 5 Radiation Sa fety Department Of fices/ Laboratories , WNSLWest. Bulk storage area for waste from Science Area, toprocess and prepare waste for shipment.
Figure 6 Radiation Safety Department Of fices/ Laboratories, C-1, 2,3, 6 4 Kline Biology Tower.
Figure 7 Science Area Waste Area, J.W.Gibbs. Ussd by Radiation
Safety Department staf f for comoaction and processing ofwaste.
The equipment listed below represents the Instrumentation utilized in theoverall radiation safety program at Yale. This list represents a summary ofequipment at the time of the application. Instrumentation with slmtlaroperating characteristics may be substituted in the future as needs dictate.
i
Description Vendor Model flumber Quantity Radiations Detected
item 10: Radiation Safety ProgramApplication for Use of Isotopes
Application for use of isotopes in a project is made using the enclosedgreen form. The approval, if and when given, is for a maximum of threeyears. The a w Mal may expire if the total activity indicated on the form isconsumed pric- - he three year approval. Therefore, there is a continuousstream of reau as. There are three levels of review by the Radiation SafetyCommittee.
1. For new users (or renewal ir.volving larger levels of isotopes,or particularly hazardous isotopes, or investigators who mayhave had problems in the past) the full sub-:ommittee willreview. The sub-committee will either be totally satisfied withthe application and approve it, or, if there is some unresolvedquestion, it will be re ferrad to the full Committes.
2. The full Committee will review applications when legal problemsappear to be involved, if an environmental use of material isplanned, or if referred by the sub-committee.
3. For renewals of smaller amounts or routine uses of isotopes thereview will be conducted by George R. Holeman and eitherFrederick W. Greenhalgh or Kenneth W. Price. If they are
satisfied with the applications, approval is given. Generally,satisfaction is gained by negotiating with the PrincipalInvestigator; however, if not satis fied, it is referred to thefull Committee. Renewals of more hazardous isotopes or largerquantities will be rev'.ewed by the full sub-committee.
Approvals are not given until all questions raised by those reviewing theapplications are satisfactorily addressed by the Principal Investigator. Onlyaf ter approval will a Principal Investig 3r be able to order isotopes. All
orders are placed by Radiation Safety Department staf f directly with thevendors. Records of all orders are maintained by the Radiation SafetyDepartment.
Minutes of Radiation Safety Committee meetings are maintained. Copics ofthe approved green forms are maintained together with supporting informationin the Principal Investigators' files in the Radiation Safety Department.Files of all safety evaluations and laboratory surveys are maintained by theRadiation Sa fe ty Departmen t.
,
The Radiation Safety Committee has adopted tv philosophy of keepingradiation exposures to "as low as reasonably echievable". Radiation exposuresas _ recorded on film badges are reviewed monthl', by the Radiation Sa fetyDepartment. Internal exposures as determined from bioassay samples (urine)are reviewed and analyzed by a health physicist. Thyroid burdens are reviewedquarterly to determine patterns and possible areas of reducing exposures.Tabulations of the exposures-are sent to Radiation Sa fety Committee membersfor review as part of a semi-annual report to the Committee.
YALE UNIVERSITY APPLI h N OFFICE USE ONLYFOR THE USE OF RAD 101SOTDFES pprovod by:
Note:IT IS ESSENTIAL TO FILL 007 THIS FORM IN ITS ENTIRETY.Please fill out in duplicate and return BOTH copies to:RADIATION SAFETY DEPARINENT, 314 Wright NuclearStructure Laboratory, West - 260 Whitney Avenue,At.tention: Claire Mulvaney. Phone 432-3040
Date ( Authorisation will expire 36 months from application date).
Faculty1. Name of Principal Investigator Rank
Room No. & Bldg. _ All rooms in whichf ootope is to
De par tment, _ be used
Telephone No.
2. Isotope desired (PLEASE COMPLETE ONE SET OF FORMS FOR. EACH ISOTOPE)
Estimated quantity to be used during next THREE years Millicurie(s)e. ,
B. Maximum quantity to be purchased at any one time Hillicurie(e)
C. Maximum quantity to have on hand at any one time Millicurie(s)
D. Form: Liquid ( ) Gas ( ) Powder ( ) - Will powder be dissolved in
shipping vial? ( ) - Please describe alternative procedures in Item 5.
E. Are any of the following items to be used?
Infectious viruses Yes ( ) No ( ) - (If answer to either is Yes, pleaseoutline deactivation in Item 5).
Carcinogenic agents Yes ( ) No ( )
Other bichazards Yes ( ) No ( ) - (If Yes, explain in item 5).
F. Are animals to be used? ( ) No-( ) Ty pe Will Division of-
Animal. Care be involved in caring for radioactive animals? Yes ( ) No ( )
3. List experience of Principal Investigator, relating to isotopes, in detail
4.: The following If st of persons who will use or be exposed to radiation under--this autheyization have been instructed by the Principal Investigator in theradiation protection problems and appropriate precautions to minimite exposureassociated with the above isotope. Everyone using radioactive isotopes must _belisted and attend a Radiation Safety Seminar presented by the Radiation- Safety
The Radiation Safety Committee is charged with overseeing t.he activitiesof the Radiation Safety Of ficer and the Radiation Safety Department. The
Radiation Safety Departmerit acts as an aid to the Committee and works directlyunder the technical supervision of the University's- Radiation SafetyCommittee. . The Yale University research program is a large undertaking andthe Radiation Safety Commit tee is continuously reviewing the radiation safetyprogram. Semi-annual reports are submitted to the Committee by the RadiationSa fety Department. An annual review of the Radiation Safety Departmentprogram is made. by the Radiation Safety Comn.ittee. It has been arranged withthe Deputy Provost for the Biomedical Sciences to participate in the annualreview. The Deputy Provost will act as the University's representative duringthis annual review of the University's program.
SPECIFIC PRINCIPAL INVESTICATOR RESPONSIBILITIES-
Authorized Principal Investigators are responsible for ensuring that thefollowing individual user responsibilities are discharged by those under theircontrol and are further responsible for:
1. Adequate planning of experiments and determination of the type andquantity of radiation or radioactive material to be used. Thisdetermination will generally give a good indication of the safetymeasures that should be employed. Experimental procedures must bewell outlined to allow adequate review of safety precautions at thetime of authorization by the Radiation Safety Department andRadiation Safety Committee as a protocol is a significant part of theapplication. Where possible, a cold run using the planned proceduresor tracer quantities of radioactive material is recommended to avoidunforeseen safety problems. In any situation where there is anappreciable quantity of radioactive material used which varies fromthe authorized protocol, the Radiation Safety Department must beconsulted before' proceeding.
2. Providing radiation safety training to those employees for whom theyare responsible. Instructing them in the use of safe techniques andin the application of approved radiation safety practices, andassuring that employees attend a radiation sa fety seminar presented~
by the Radiation Safety Department.
3. Furnishing the Radiation Safety Department with informationconcerning individuals and activities in their areas, particularlypertinent changes' in their personnel rosters. Individuals under theage of 18 are not permitted to be employed in areas where they may beexposed to radiation.
4 Contacting the Radiation Safety Department when:
a. There are maior changes in operational procedures, newtechniques, use of dif ferent isotopes;
b. There are renovations, or alterations by Physical Plant (forexample, the removal of a radiochemical fume hood);
c. When new operations are anticipated which might lead topersonnel exposures;
-d. Changing location, or leaving the University.
-5. Complying with the regulations governing the use of radioactivematerials as established by the United States Nuclear RegulatoryCommission (NRC) and the Yale Redistion Safety Committee for:
a. Using proper procurement and trans fer procedures,.
b. Transporting of radioactive materials between areas within Yale,'
including cross campus trans fers involving public streets;,
c. Properly posting areas where radioisotopes are stored or used,-or where radiation fields may exist; -
d. Se. curing-of radioisotopes in their possession from unauthorizeduse;
e. Recording the receipt , transfer and disposal of radioactivematerials in their area, including sealed sources, such as ionsources Ir. gas chromatographs and static eliminate rs. ThePrincipal Investigator should submit radioactive materialinventory data on a quarterly basis. Document &nd recordsemi-annual scaled source leak tests;
f. Assuring that all radioactive waste materiels are disposed inaccordance with NRC regulations or tre transferred properly tothe Radiation Safety Department for disposal in compliartce withRadiation Safety Department requirements; documenting andrecording all waste disposal actions in the laboratory. ThePrincipal Investigator is responsible for safe and properstorage of all radioactive waste until picked up by the- Radiation Safety Department;
g. Assuring that appropriate records of radioactive waste aremaintained and are reported to the Radiation Safety Departmenton a quarterly basis;
h. Providing adequate instrumentation for assessing potentialradiation exposures in their area and performing routine surveysof the work area as necessary;
i. Taking steps to prevent the transfer of radioactive materials tounauthorized individuals. This includes the proper disposition
of radioactive materials possessed by terminating employeesand/or students;
i. Meeting with laboratory personnel to review film badge exposureresults provided by the Radiation Safety Department;
k. Responsible for prompt distribution and return of all dosimetrydevices issued by the Radiation Safety Department.
6. Keeping all exposures to radiation as inw as reasonably achievable,and specifically below the maximum permissible exposures listed in 10CFR Part 20. " Standards for Protection Against Radiation".
7. Keeping the stock of stored, toeked radioactive materials ~to aminimum within laboratory areas. Authorized users may utilize thestorage facilities located in 1138 Kline Biology Tower or I-248Sterling Hall of Medicine for large quantities of radioactivematerial not needed in current research.
8. Ensuring that service personnel are not permitted to work onequipment, hoods, or sinks in areas where radioactive materials areused without the supervision or guldance of a niember of thelaboratory staff to provide specific information. Contact theRadiation Safety Department prior to allowing Physical Plant orservice personnel to work in certa'in areas such as radioisotope
hoods, sinks where radioactive liquids may be present, or such otherareas or equipment that may have significant contamination.
9 Complying with proper procedures for termination of employment ortermination of any axperiment using radioactive materials. Theauthorized user must return to the Radiation Safety Department allradioactive materials, including waste, assigned to him. An
alternative would be to transfer radioactive materials to anotherauthorized Principal Investigator with prior approval, of theRadiation Sa fe ty Department. Particular care should be exercised tosee that specialized equipment such as personnel monitoring devices(namely, film badges) are returned to the Radiation SafetyDetertment. A final laboratory decommission survey is also necessaryprior to renovating a laboratory or leaving the University. TheRadiation' Sa fety Department should be notified well in advance for adecommission survey.
10. Assuring that radioactive materials are not trans ferred within or-outside of the University without first notifying the RadiationSafety Department' for proper supervision,
q
11. The Principal Investigator should inform Radiation Sa fety Departmentof all declared pregnancies as soor as porsibic.
12. Contacting the Radiation Safety Department when Yale students underthe age of 18 are involved with experiments using radioactivematerial ir, approved courses.
Each individual at Yale who has any contact with radioactive materials orradiation producing equipment, is responsible for:
1. Keeping his exposure to radiation as low as reasonably achievable,and well below the maximum permissible expoteres as listed in 10CFRPart 20.
2. Wearing the appropriate personnel monitoring equipment such as filmbadges. -finger rings, or TLDs as prescribed by the Radiation SafetyDepartment.- Badges are assigned to those individuals who, in theirwork, might receive an exposure of 25% of the occupational limitsgiven in 10CFR Part 20. Personnel who work only with pure alpha
emitters, or only with pure bete emiga S, or RIA kits) will noters having a maximum energy of
3 , 10 ,less than 0.2 mEv (namely, H 0be required to wear film badges. Such dosimetry devices should bereturned promptly at the prescribed time and when terminatingemp1oyment.
3. Surveying his/her hands, shoes, and body for radioactivecontamination before leavint the Wratory and documenting the wipetest and meter survey results (date, name, and ccntamination level).Upon detecting skin contamination the Radiation Safety Departmentshould be notified immediately.
4. Utilizing all appropriate protective measures when working withradioactive materials. Such recommended measures may include:
_
a. Wearing protective clothing (laboratory coat) whenever workingwith radioisotopes, and not wearing such clothing outside of the
.- laboratory area;
b. Wearing disposable rubber gloves, laboratory coats, eyeprotection, and following other safety precautions as deemednecessary by the Radiation Safety Department;
c. Using appropriate radiation shields. Consult with the RadiationSafety Department for advice concerning appropriate shielding;
d. Using mechanical devices or remote handling devices whenappropriate to reduce exposure to the extremities;-
e. Using automatic or remote ' pipette filling devices.
f. Performing radioactive work within confines of an approved hoodor glove box if it is suspected radioactive material may bereleased into the air. Some isotope work requires the use of ahood or a glove box.
g. Notifying the Princip.1 Investigator of all confirmedpregnancies as soon ar, possible.
5. Eating, drinking and/or smoking in areas where radioactive materialsare present is not permitted. Refrigerators should not be jointlyused for food, beverages, and radioactive materials.
6. Maintaining good personal hygiene. Do not work with radioactivematerials without protective gloves. Wash hands and arms thoroughly '
af ter working with radioactive mater 4 ts. Wear disposable rubbergloves , two pair when feasible, and c.. ange them of ten.
7. Surveying work areas f requently with wipe tests and/or surveyme te rs. Document the date, contamination levels, location of thesurvey, and nama oV the surveyor. Any contamination found should becleaned immediatd y. Contamination resulting from accidental spillsshould be directed to the Radiation Safety Department. Skincontamination should be reported immediately to the Radiation SafetyDepartment.
8. Surveying all incoming shipments of radioactive materials forcomple teness of order and possible contamination (including thevials). Document the date, name of person performing the survey andsurvey results. Open all packages on absorbent matting, in a hood if
-neces sary, and with gloves.
9. Keeping the laboratory neat and clean. The work area should be f reefrom equipment and materiala not required for the immediateprocedure. Keep or transport materials in such a manner as toprevent breakage or spillage (double container), and to ensureadequate shielding. Keep work surfaces covered with plastic-backedabsorbent material, pre ferably in a tray or pan, to limit and collectspillage in case of accident.
10. If radioactive material is to * moved between buildings, acrosscampus, or to another institution or facility the radioactivematerials must be packaged and shipped according to federalre gu la t i ons .
11. Labelling and isolating radioactive waste and equipment, such asglassware, used in laboratories for radioactive materials. Once usedfor radioactive substances, equipment should not be used for otherwork, and should not be permitted to leave the area untildemonstrated to be free of contamination.
-12. Requesting Radiation Safety Department supervision of any energencyrepair of contaminated equipment in the laboratory by shop personnelor by commercial service contrac tors.
13. Immediately reporting accidental innalation, inge s t ion skincontamination, or injury involving radioactive materials or personalcontamination to the Principal Investigator and the Radiation OafetyDepartment and carrying out their recommended corrective measures.The individual shall cooperate in any and all attempts to evaluotehis/her exposure.
14. Carrying out decontamination procedures when necessary, and takingthe necessary-steps to prevent the spread of contamination to otherareas.
15. Promptly complying with requests f rom the Radiation Sa fety Departmentconcerning body burden measurements, the submission-of bloassaysamples, determination of skin contamination levels, and schedulingfor requested radiation emergency physical examinations.
16, if someone becomes contaminated with radionctive materials contactthe Radiation Safe;:y Department imediately a f ter decontam[ nationprocedures have 1 sea initiated. Wash skin area gently with soapywater, or rinse t y: s with water, while colleagues are contacting theRadiation Safety Department for advice. During of f hours contact theCampus Police (111) for emergencies.'
USE OF RADIOACTIVE ISOTOPES
Poliev
The minimum standards for handling isotopes must meet Nuclear RegulatoryCommission regulations known as 10 CFR Part 20. In addition,
.
recommendations of the International Commission of Radiation Protection |'(ICRP) and the National Council on Radiation Protection and Measurements(NCRP) are considered to be the basis of good practice and are valuableguides.
SUGGESTED LMORATORY S AFETY PROCEDURES
Work Surfaces
All areas (bench tops, hoods , floors, etc.) as well as storage areasadjacent to _ permanent set-ups and sinks should be covered at all timeswith absorbent matting, trays, or other impervious materials. If
absorbent matting is used, it should be discarded frequently into approved- radioactive waste containers to prevent spread of contamination.
Periodic Surveys of Radiation Areas
The immediate areas (namely hoods, bench tops, and storage areas) in whichradioactive materials are being used snould be checked for contaminationperiodically by the radiation workers in that laboratory. In addition,these areas should be inspected each and every time there is reason tosuspect a contamination incident.
In general, no radioactive contamination should be tolerated. Exceptionsare active work areas which are clearly marked with the standard redistioncaution signt or tape. The Radiation Safety Department will supervise thedecontamination of such areas or equipment. The Radiation SafetyDepartment considers 100 counts per minute above background on a liquidscintillation counter to be a level of contamination requiring cleanup.
Decontamination of Areas Contaminated with Radioactivity
Preparations for decontamination should begin promptly. De termine theextent of the contamination. The Radiation Safety Department will assistin this evaluation. The individuals responsible for the contaminationwill perform the clean-up under the supervision of the Radiation Sa fetyDepartment. The area or equipment should be considered contaminar.ed untilproven otherwise.
Decontamination of Personnel Contaminated with Radioactivity
Notify the Radiation Safety Department (432-3040) immediately a f tercontamination is suspected on the body. Wash body area involvedthoroughly for 2 or 3 minutes using only lukewarm water. Immediateirrigation of the contaminated area is essential. Do not redden or breakthe skin during decontamination,-or trans fer contamination to bodyorifices. Time is critical, decontamination ef forts should begininnediately with Radiation Safety Department advice as soon as available.
Aerosols, Dusts, and Caseous Products
Procedures involving aerosols, dusts, or gaseous products, or procedureswhich might produce airborne contamination should be conduc ted in a hood,glove box, or other suitable closed system. All releases from suchsystems should not exceed the maximum permissible concentration in air forthe nuclide in ques tion. However, where practical, filters or trapsshould be incorporated in the experiment set-up to insure thatenvironmental releases are as low as reasonably achievable. Radioacticegases or materials with gaseous radioactive daughters must be stored ingas-tight containers and must be kept in areas having approvedventilation. Hoods to be used for radioisotope work should be tested bythe Radiation Safety Department to ensure that they meet the minimumrequirements for air velocity at the face of_the hood.
Iodinations,
P roce du res in which iodine vapors may be generated (iodinations) are to beconducted in a glove box or isotope hood with adequate flow rate andcharcoal _ filters. Advice should be sought f rom the Radiation Safety
. Department prior to conducting experiments with iodine and the facilitiesshould be evaluated for containment purposes. Iodinations must beperformed in approved enclosures with appropriate air sampling devices inplace. The Radiation Safety Department maintains approved iodinationfacilities which may be used on an app 'ntment only basis. The facilitiestre I-248 Sterling Hall of Medicine, 400 Laboratory of Epidemiology andl ublic Health, and 1138 Kline Biology Tower.
RECOMMENDED PROCEDURES FOR OPENING PACKAGES CONTAINING RADIOACTIVE _ MATERIALS
It is suggested that disposable laboratory gloves be vorn while opening anyreceived package.
Receiving the Package
1. All radioisotope shipments should be opened immediately and surveyedby personnel of the receiving laboratory, and then stored la a securelabeled radioisotope storage area. Vials should be wipe tested.
2. No containers should be. discarded as closed boxes in the regulartrash. All lids and dry ice are to be removed so the box is visiblyempty.. Such containers must be torn or otherwise disassembled so asto make them useless.
3. All radioactive labels on the empty containers should be destroyed ordefaced. Outer containers which have had labels defaced and are freeof contamination may be disposed of in normal trash.
Opcning the Package,
1. Place package in vented hood, if necessary.
2. Wipe test package for removable contamination with filter paper an -count for activity
3. If the package contains gamma or high energy beta emitters, checkdose rate on outside of package with survey meter.
4. Open outer psckage and remove packing slip. Open inner package andverify that the contents agree in name and quantity with isotope andquantity ordered.
i
5. Check for possible breakage of seals or containers, loss of liquid orchange in color in absorbent material, or gross removabincontamination.*
6. Wipe test innermost container (vial), Note: The liner, shield, andisotope container may have surf ace contamination; they should bediscarded as radioactive waste.
7. Record type of activity, quantity present in receiving log such aslaboratory data book.
8.- If contamination, leakage or variations in isotope. or quantityordered are observed, notify the Radiation Safety Department(432-3040).
Additional Elements of the Radiation Safety Program
An isotope inventory is compiled by the Radiation Safety Department eachquarter. Each Principal Investigator is required to submit a currentinventory. The information is compiledLand reviewed. These records arecomputerized and retained.
s _ _ _ . - . , __ _ _ _ _ . ~ . _ , - -
. . . . . _ _ . _. . _ _ . . - ._ . . ,
O O.
11azard evaluations are perforiced regularly. These evalations may beinstituted by review of a new t>rincipal Investicator isotope application, a
film badge exposure, a positive bioassay, a spill, contamination on equipmentor personnel, or request by Principal Investigator or staf f member.
Contamination surveys are performed quarterly. The surveys include bothsurvey meter and smear samples. Decommission surveys ore performed when aPrincloal Investigator vacates his tar,111 ties. Survey records are maintainedand reports of tusults are forparded to each Principal Investigator.
Centralized multiuse radioisotope facilities supervised by ',he RadiationSafety Department are maintained for research personnel working with largeamounts of radioactive macerial. Indination procedures are required to be-performed in approved hot laboratorire The Radiation Safety Department
maintains two centra acilitiegquipped with alr _ sampling equipment tomonior releases of 1. The I cancentrations are measured before andaf ter tiltration as well as the room air concentration. TheMa records arecomputerized within the Radiation Safety Department.
.
Leak tests are performed on sealed sources of 1 mci or more every six months.The leak tes t records are in the proces s of being compute rized.
Princloal Inveatigators are required to maintain records of sink disposal ofisotopes , radioisotope inventories, and their own survey results for review bythe Radiation Safety Department. Radioactive waste recorda are nainta inedlocally by the Principal Investigator and centrally by the Radiction S 4fetyDe p ar tm en t . This includes waste which is shipped , s tored, disposed in thesanitary sewage system, or held for decay. The radioactive waste records arein the process of computerization.
,
5 A_ni, mal Care P rocedoresn
The Principal Investigatore normally care for radioactive animals in their ownf aellities utilizing standard cages, bedding, et:. They are responsible forthe prope r cleaning, labeling, and decontamination of the cages as well as theappropriate disposal of carcasses.
The Animal Care Division generates a form " REQUEST TO USE HA7ARDOJS AGENTS ORMATERIALS". This form must be completed by all investigators who plan to useanimals or Animal Care facilities. If isotopes are to be uved, the form isforwarded to the- Radiation Safety Department and approval is contingent onapproval by the Health Physicist responsible for radiation safety in AnimalCare f acilities. '
Pursuant to receipt of the above form, a le t te r is forwarded to the PrincipalInvestigator from the Radiation Safety Department. This letter instructs thePrincipal Investigator that prior to using isotopes in animals in which AnimalCare personnel are involved, he, or the person actually performing theexperiment, must meet with an Animal Care supervisor and the Health Physicistin order to establish the specific radiation safety precautions which arerequired for the experiment under consideration. Copies of the form andstandard letter are attached.
This memo pertains to your application dated 06/25/87 to use 3H in animal carefacilities.
Prior to the initial experiment involving animi care personnel, a meetingwith Fred Greenhalgh of radiation safety (432-3047) and Barbara Galli ofAnimal care Division (785-2526) and the person actually performing the-experiment must be held in order to agree mutually on the specific radiationsafety procedures which will be implemented during each animal experiment.
Arrangements for disposal of bedding, carcasses and other radioactive wastemust be made with radiation safety prior to the initial experiment.
1
All cages must be lab 31ed with isotope, amount of isotope in the animal andthe date the experiment started.
The principal investigator is responsible for ensuring that all cages whichhave contained radioactive animals have been properly decontaminated beforethey. are *:eturned to the Animi Care Division.
-!N$TRUCTION$t - Before beginning research that requires the use of hazardous agents or sterials-in a.imals,please complete this- form (Sections 1.VII) and sutalt it for approval to the Ofrector. Divi-Sion of. Animal Care. L50G-ll3. Your cooperation will protect the health of personnel and j
It is the intent of the Radiation Sa fety Committee to maintain occupationalradiation exposures at , minimum. In order to accomplish this, the followingmethods of personnel - itoring are employed:
1. Film Badges
Except for individuals using soft beta emitters (beta emitters withmaximum energy less than 0.2 mEv) and pure alpha emit * era, anyonedirectly involved with radioactive materials, or ionizing rad:stion
,
producing equipment at University facilities will be reauired to haveand wear a film badge when working. Other University employees whoare not directly involved with radioactive materials as defined in 10CFR Part 19 ray reques t film badges from the Radiation SafetyDepartment. ^{nger ring radiation gonitors are strongly recommendedwhen handli.g, more than 10 mci of 3'P and in other situations wherethe hand exposures may be significant. Finger ring dosimeters shouldalso be requested from the Radiation Safety Department when needed.' Finger rings should be worn on the finger which is mostly likely toreceive the highest exposure as a conservative indicator. Also, thechip s de of the ring should be worn on the front or back of the4
finger depending on the geometry of the hand vs the radioactivematerial in the experiment.
2. Bionssays
Individuals involved in operations which utilize tritium in a formother than a sealed source or metallic foil, -in amounts greater than10 millicuries , or 100 millicuriec of nap *a, should submit u6 tu.samples for analysis- Tne samples sumb? .ted should be taken 24 hoursaf ter a single experiment. For co tinu. ,9 esperiments, samples may
'
be' required at weekly intervals or other f requency- es tablished by theRadiation Safety Department. In some cases, urine samples may berequested from radioactive iodine users and other radioisotopeusers. Arrangements for this service should be made through theRadiation Sa fety tepartment. Bionssays may be requested forindividuals using isotopes other than tritium or as follow-up onspills. Women may dteide to submit a background urine sample when apregnancy is con firmed.
3. . Thyroid Counts.
Individuals working with significant quantities of radioactive iodineisotopes should have thyroid counts on a fraquency established by theRadiation Sa fe ty Department. When indicated, thyroid monitoring isrecommended subsequent to iodination procedures involving one
%E millicurie or more of iodine. Thyroid monitoring is otfered on aweekly basis. If there is an accident or r;ill involving radioactiveiodine the Radiation Safety Department should be contacted formoni tor ing radioac tive potential thyroid uptake. In some cases,
wcmen-with con firmed pregnancies may be required to have a backgroundthyroid : aunt and periodic counts for the dura. ion of gestation.
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EMPLOYMENT OF MINORS -
Minors who have not reached the age of 18 shall not be employed in any areawhere they may be exposed to radiation, such as (sotope laboratories and areaswhich contain radiation producing equipment. This- policy is intended for allminors except for registered Yale University students.
CONTROL OF-STUDENT EXPOSURE TO RADIATION
The following guides are recommended with respect to the uses of ionizingradiation-in educational institutions and should be distributed to studentsparticipating in demonstrations and/or experiments involving radiatica:
1. Persons'in the^ general population at any age: Such individualsshould not receive an exposure exceeding 0.5 rem per year in additionto natural backgrou-d and medical exposurcs. Thic limit applies tothose persons who are not occupationally exposed. If an instruc tor
or student of age 18 or greater is subjected routinely to workinvolving radiation, then he or she is an occupational worker and theexposure limit or 5 rem per year applies.
2. Persons urder 18 years of -age: The individuals shall not beoccupatie nally exposed to radiation. Therefore, individuals under 18years o14 shall not be employed in an isotope laboratory.
3. Yale -students under 18 years of age exposed during educationalactivities: such irdividuals should not receive whole body exposureexceeding 0.1 rem per year due to their educational activity. Toprovide an additional f ac tor of safety, it is recommended that eachexperiment be so planned that no individual receives more than 0.01rem while conducting or participating in the experiment.
'4. : Students over 18 years of age exposed during educational activitiesfall into category 1 above.
' OCCUPATIONALLY EXPOSED EMPLOYEES WITH PLANNED OR CONFIRME3 FRECNANCIFS
In cases of confirmed pregnancies, an occupationally exposed worker should'in form the Principal Investigator who in turn should in form the RadiationSa fety Department. The pregnant worker should not be exposed to more than 0.5rem Ser gestational period .the exposure limit for the general public. Thep'ignant' worker should be ' responsible for minimizing exposure to the fe tus .In some cases , the Radiation Safety Department may recommend baselinebinassays or increase the frequency of bioassays and/cr monitoring,particularly when iodination procedures or experiments using high levels ofradiation are involved.
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Yale University Instrument Calibration
Introduction:
Instrumentation for which a gton beam calibration is appropriate iscalibrated semi-annually using a Ce source. The general guidelines listedbelow are followed for each calibration procedure:
137Cs beamExposure is performed'using a*
The actual exposure rate is traceable to NBS by-
measurements performed with an NBS calibratedinstrument
* The frequency is semi-annually
Instruments are calibrated at approximately 1/3 and 2/3-
'
of full scale
The largest exposure rate available is 1.0 R/hr
* A calibration certificate is generated for eachinstrument'with percents of the actual exposurerates indicated
Any instrument for which the dif ference between the*
actual and indicated exposure rate is greater than10% but less than or equal to 20% will have thecalibration certificate, or acceptable facsimile orin formation, attached to the ins trument.
Description of Facility:
The attached figure shows the general layout of the calibration facility.137Cs located within an irradiator.'The source is approximately 7 Curies of
The source must be raised in order to calibrate. This mechanism is locked atall times.- The key to the -source vchanism is locked -in a cabinet in theRadiation Sa fe ty Department's o f f t . The irradiator itself is located withinthe radioactive waste storage area, ich is also kept locked. Only those,
| individuals requiring instrument cai7 9 tion are permitted acces s to the key.
L These individuals generally include im . tation Sa fety Department Health|- Physicists and experienced technicians. Use of the facility is not availableI to University s tudents or outside agencies.
The radiation geometry is broad beam, and traceability to NBS isaccomplished by direct measurement of exposure rate using Victoreen R-Chambers(or equivalent) which are ca!% rated with NBS traceability. By placing variousabsorbers over the source collimator a reduction in exposure rate is attained.
An audible alarm sounds, with an indicating flashing red light, when thesource is raised to the irradiation position. A computer code is used todeter nine the exposure rate at any distance with a given filter over thecoll _mator. - Alignment of the instrumentation is accomplished with a laser beam.
!
All individuals using the facility are given verbal instruction by aHealth Physicist , are required to have a film badge in place, and should enterthe area with a pertable survey meter with an audible indicator.
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UNIVERSITY PLAN FOR RADIAIJpil_ACCIDEllIS
Emergencies involving radioactive meterial at the University may beclassified into three general categories. The actions required of
Theindividuals involved vary according to the accident classification.three accident categories are given in the following table along with the
immediate action that should be taken v's" appropriate phone numbers.mostAlso included is the section of this app- 54 which should be consulted for
.more detailed information, ',
RADIATION ACCIDElfT CLASSIFICATI0HS
EMERGEHCY CLASSIFICATI0HE IMMEDIATE ACTIONS SEE SECTION ifUMBEROf_Ill15._AEHilE1X _
LLEE_IHEAIIl[Illq_IlLIURI and *** CALL 111 *** I then III
Radioactive Contamination (Campus Police)
*** CALL 432-3040 ***Radiation Safety Department
ELEQR_1HJURY and Give first aid if II then III
Radioactive Contamination possible confine spreadof contamination
A** CALL 432-3040 ***Radiation Safety Department
*** CALL 111 ***(Campus Police)
NO IHJURI with rele as e, - Restrict area III
spill and/or body ,
contamination *** CALL 432-3040 ***Radiation Safety Department
*** CALL 111 ***(Cempus Police) .
,
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Lcor'anued)
.
!. Lilg_Jhtggignina Injury and Rad 1oaet1ye Cnntamingtlon
It.ls imperative in all cases of life threatening injuries that litosaving actions be to: sn immediately regardless of the radiation hazards.Only after the victim has been attended to medically should one be concernedwith the radiation hazard. An external exposure to a radiation source willnot make the victim radioactive or " contaminated". Contamination willresult only if a powder, liquid, or other similar dispersible materialcontaining radioactive material is accidently spilled on the victim. If
radloactive contamination is not involved the victim should be treated asany other emergency case. It la very important to know if radioactivecontamination is involved as the presence of radioactive contaminationsignificantly alters the way in which the Yale-Hew Haven Hospital EmergencyRoom receives the patient. The following guidollnes snould be followed whenan accident occurs in a radioactive materials laboratory whlch involves lifethreatening injury and radioactive contamination,
1. Assess the medical condition of the victim and render first aid asrequired.- Try to determine the extent of the injury.
2. Call or have a co-worker call the Campus Pollce at 111 or 432-4400.
3. The following information should be relayed to the police officers
a. Victim's nameb. Victim's location - building and number -
c. Hature of injuriesd. Your name and phone numbere. The radioactive material present on the victim and approximate
quantity.
4. The Campus Police may call back to verify your call.
5. Awalt the arrival of emergency personnel. If possible, send aco-worker to meet the ambulance in * rder to escort emergencymedical personnel to the accident nem,*.
6. Remove contaminated items and clothing from the victim if themedical condition is such that such actions would not do furtherharm to the victim.
7. If time permits, place absorbent matting on the floor to provide anon-contaminated path for the emergency crew.
8.. Accompany.the victim to tne emergency room. You may be able toprovide valuable inf emation to the medical team attending thevictim.
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_Lcnntinutdl
II. Minor Injury and Radioactive CQRthalDallan
Accidents involving radloactive ctatamination and injuries which are notlife threatening may be treated with less urgency. licwe ve r , as in the case
of very serious injury, you must assess the medical condition and give firstaid immediately. Once it is determined that the injury does not requiretransport to the Yale-Hew Haven Hospital. Emergency Room the followingguidelines should be followed in responding to such emergencies.
1. Evaluate the nature of the injury. Give first aid immediately.
2. Hear rubber gloves and sponge and/or flush the contaminated area Ifpossible. Be careful not to spread contamination.
3. During normal working hours contact
RADIATION SAFETY 432-3040OR
CAMPUS POLICE 211 or 432-4400
During off hours contacti '
CAMPUS POLICE 111 or 432-4400
4. Give details of the accident, the redloactive material present.your location, your name, and_your phone number.
5. The Radiation Safety Department will provide you with-instructionsfor dealing with the accident.
6. If it is necessary to, transport an Individual to the Yale-tiew HavenHospital Emergency Room the Campus Police will provide thetransportation. The exact details of this transfer will depend onthe extent of the injuries and radioactive contamination present.An Individual with a minor injury should not be taken to thehospital emergency room without first centacting the RadiationSafety Department for guidance..
7. LRemove any contaminated clothing and Jacontaminate as instructed bythe Radiation Safety Department.
8. Prevent the spread of contaminatlan by isolating and sealing theaccident area. Keep people cott Shut down ventilation if possible.
!!I . !!D_lnigry with R11ggina Spill _andLQr_Radv Contgalna_tIDD
EKtteen_Iloturds - high radiation levels (100 mrem /hr) or the possibility1. . of airborne contamination from dry or volatile radioactive materials.
Evacuate the laboratory Immediately; close and lock the door and/ora.stand guard to prevent entrance; during normal working hours,immediately contact the Radiation Safety Department and givedetails of the accident. (Phone 432-3040).
.
b. During off hours, evacuate laboratory, elone and lock the door,call Campus Police (phone ill or 432-4400) and glve details of theaccident and await ins'. ructions. The Campt- lice will contact
Radiation Safety Depa.tment personnel. Radis.lon Safety Department
personnel will then contact the individual and give instructions.
If you have to leave the area to call Radiation Safety DepartmentD
c.or remove your shoes before leaving theor Campus Police, coest
area if you suspect contamination and do not touch anythingunnecessarily.
d. Ilold your breath when passible until leaving the immediate area ofalble h Lh 31r* rno concentrations.
2. Qibar_Betards
Accidents involving both redloactive material and infectiousa.viruses.
D'. activate the virus and notif y the Radiation Saf ety Department(432-3040) and Biological Safety (432-0257), or during off hours,call Campus Police at 111 and awalt instructions.
b. Fires, explosions, etc., involving radioactive materials.
All personnel in the area should immediately leave the area as anorderly group and go to en area where there is a non-11tethreatening condition and sound the nearest fire alarm. Once in asafe area, notif y the Campus - Police (111) immediately. Hotify them
of any injured personnel. Do not leave your safe area withoutfirst being monitored for radioactive contamination. Call
use common seuse, protect people, do not spread. Keep calm,Always assume you sre contaminated until a survey showscontamination.
otherwises call Radiation Safety Department or Campus police and awaitinstructions,
Confine Contaminationa.
(1) Localize the ' spill. Right a tipped container, drop absorbentmaterial on the spill, . damp down a dry spill to prevent it beingairborne. Always wear gloves when working with a spill.
Do not track contamination about the laboratory. Call, do not(2),
go for' help if possible. Prevent others from entering theimmediate contamination area'.
(3) Close doors and where possible, adjust ventilation to preventthe spread of airborne contamination.
Check your shoes before leaving the area of a cleaned up spill.(4).
b. Protect Personnel
(1) Remove contaminated clothing and gently wach contaminatedDo not redden or' parts of the body with mild detergent.
abrade the skint.
(2) De especially thornugh in flushing out wounds with cold water. .
(3) lloid your breath if airborne contamination is suspocted, or4
.until you leave the area.
)(4) Harn other workers.
IV. --Pos t ' AccidanLERE2LilDU
for certain types of accidente, the Radiation Safety Department may beTherequired to report to authorities outside Yale University.
of theRadlation <Saf ety Department will require the cooperatic::principal Inves,tigator and individual users in collecting data and inrevising procedures to prevent-recurrences.
HEHO Tot Prof. Peter D.' ParkerChairman Radiation Safety Committee'
FROH i - George R.1101eman ['
SUBJECT: . Radiation Emergency Notification-
Fodero, D'. DeborahDuring a meeting with' Dr, Daniel Rowe Hr.' S. D. r!McGregor, you, and .myself.. It was decided that the emergency notification
beeper between the Campus Police Department ~ nnd the Radiation SafetyDepartment; staff will be eliminated effective January 12, 1987. The following
_
call. sequence'will be' instituted instead of the beeper-
When an emergency call is received by C:mpus Police for a radiationemergen:y or any other emergency involving ani environmental or. sa fety element , the main desk at the University llealth ServicesxCenter will'be called.- The main desk will call Vic Osborne. Vic
-Osborne-will then decide whom to calls Biological, Chemical, orRadiation Safety staf f. Vic will:have a llating of home and'
' .individua11 beeper numhara for the Hanagement and Professionalmembers of the Radiation Safety-staff. This-system will becomeef fe:tive January 12,_1987. It will undergo a review to evaluateef ficiancy in approximately six weeks after initiation.
Af ter"the Radiation Safety Committee' review-and approval, the NuclearRegulatory Commission abould be notified about the change-in emergency.
-. notification procedures.
s
CRll-cm .'
c c t -. Dr.' Daniel RoweMr. S. D. Fodero .Dr. Deborah McGregor
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nk e i na~.< ^"c~J Ouvreienal $ kry I)<rarrant Tekylwne:4
To: Deborah McGregor, M.D. , ll.p.ll. , Director ' trDIS ,
/m [I,y,-### 'Fran: Victor Osborne, Director - Occupational Safety /&I -;
Es: Dergency nesponse
It is my understanding that campus Iblice are to call the front desk atthe Yale llealth Service for all emergencies, except fire, that occur after5:00 p.m. on weekends aM holidays. Once notified, the desk atteMant
.will contact me at hame er on my beeper. I, in turn, will contact the
appropriate people in the ''1 vision to respord to the emergency.
If for scene reason, i.e. , vacations, ' 111 ness, etc., I am not available, I*
wil_1 need backup people. Itay I sucfjest Ihll colavecchio as first bachrp;Fred Greenhalgh as secord backup and as thirti backup person, Cacol. Weeks.'Ibese people should also have everyone's hcane phone aid beyer numbaru Jn
aadditicn to the number for the front desk, the infirmary a;. the Yalellealth Servico, ard the campus Iblico.
It will be h rare occasion when .T am not available, however, the rest ofthe Division should be prepared to respoid when necessaty.
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l'.O. Itos sp3 < ult Station 2.s4s6.It,IR.
Neu Il.sven, Connalitut repof
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>To:- All Receptionists, Front Desk, Yale llealtli Service
From: January '12, - 1987-
0- -As of January 12, 1987, . any call you receive after 5:00-p.m., on weekends,holidays or recess periods that involve a problem with Radiation,. ;
- 01emical,- Biological- or other similar hazanis, . contact pag of the-
following people startirs at the top of the list..
Item 11: Radiosctive Waste Management and Procedures
The following waste streams are addressed in this application: solid,
liquid, gaseous, biological, liquid scintillation waste, both regulated,
and deregulated, and below regulatory concern. For all waste streamsappropriate records will be maintained.
1. Solid Waste
4 Short half-life radioactive waste with a half-life of less than,
300 days may be processed and monitored by Radiation SafetyDepartment staff and then diset.rded in a Connecticut ~ permittedsanitary land fill in accordance with the guideline in " Disposalof Short-Lived Radionuclide Waste in a Sanitary Landfill: FinalReport" dated February 1987 of the Texas Low-Level RadioacttweWaste Disposal Authority. (See attached Table 2-2.);
# Short helf-life radioac tive waste with a half-life of less than100 days may be held for decay and then processed, monitored anddiscarded in the regular trash by Radiation Safety Departmentstaf f without regard to its previous radioaccivity;
# Short half-life radioac tive was te with a half-life of ler.- than100 days may be held for decay and then shredded, processed,
~
monitored and discarded in the regular trash-by Radiat in Safety#
Department staff without regard to its previous radio etivity;
# Bulk solid waste may be shipped to an appropriate licenseddisposal site, 'if available. ' Licensed brokers, such as RadiacResearch Corporation may be used;
# Solid waste may be compacted and then ' shipped as solid waste toa licensed burial site. Licensed brokers may be used;
,
# Solid waste may be shippei as bu'k waste or compacted waste to alicer. sed super-compactor facility for further volume reduc tionprior to burial;
# - Short-lived solid waste .may be held for decay and incinerated inthe Yale Medical School incinerator according to 10 CFR Part20.305. Calculations will be made to assess the concentrationin air and applicable Minimum Permissable Concentration (MPC)values will be used. Ash will be sampled; if it meets the
1
environmental MPC for waste water it may be discarded as regular |ash; j
# Solid waste with a half-life of less than 100 days may be held I
for decay, and then processed, monitored and shipped to acommercial incinerator;
# solid waste may be incinerated at tie Yale Medicat Schoolincinerator provided the MPC for air is met as de termined bycalculations and the ash may be discarded as regular ash if it-mee ts the environmental MPC for water.
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2. 1.iquid Waste
#- Liquid waste may be discarded to the eenitary sewer according tothe~ provision of 10 CFR Part 20.303;
# Liquid waste may be held for decay and then discarded to thesanitary sewer according to the provisions of 10 CFR Part 20.303;
# Liquid waste, containing hazardous waste, with a half-life ofless than 100 days may be held for decay and then monitored,
declared non-radioactive and discarded as hazardous vaste inaccordance with Environmental Protection Agency hazardouschemical disposal provisions;
3H# Bulk li tuid waste (liquid scintillation fluid) containingand 14C may be declared non-radioactive according to 10 CFRPart 20.306, and discarded without regard to its previousradioactivity;
-# Liquid waste may be a3 sorbed a ccording to spec .fic burial site-::riteria and shipped to a N1al s' te. A licensed broker may beused.
3. Gaseous Waste
# Gaseous or volatile waste may be released to the environment inaccordance with applicable- MPC air values;
# Gaseous or volatile waste may be filtered, or trapped if*
appropriate, prior to release to the environment;
#_ Gaseous waste -may be shipped to a burial site for disposal, inaccordance with specific site criteria;
,
# 'Short-lived gaseous wast; with half-lives of les 9_ than 100 daysmay be held for decay and then released to the environment.
4 Biological Waste
#- Biological waste may be frozen and shipped for burial;
# Biological waste may be frozen, held for decay and then shippedfor burial;
# Biological waste 'with half-lives of less than 100 days may be'
f rozen, held for decay, monitored and then released tocommercial incinerators;
# Biological waste may be frozen, held for decay, monitored andincinerated in the Yale Medical School incinerator;
# Biological waste may be monitored and then incinerated at theYa'a Medical School incinerator;.
# Biological waste with 3H and 14C may be monitered and then |processed as no longer radioactive in accordance with 10 CFR
#. may be shipped for processing and 1 urial as radioac tive was te;
# may be diitilled, the solvent recycled, and the sludge treatedas radioactive waste;
# vials mav be crushed centrally at Ytle University, the liquidseparated from glass and plastic, tne vials washed , sampled , andtreated as regular broken glass trash. The non-toxic liquid maybe sampled and released to sewer as liquid waste. Toxic fluorsmay be processed, sampled and treated as bulk hazardous liquidwaste.
# may be shipped for processing and commercially incinerated;
# may be dis tilled, the solvent recycled, the sludge treated asradioactive vaste;
# vials may be crushed, and the glass washed, monitored andtreated as broken glass trash. Wash water is treated as liquidwaste and released to sewer. Non-toxic fluors may r a sampledand released as hazardous wes te-
Peference: Rogers and Associates Report RAE-8514-2, " Disposal of Short-LivedRadionuclide Wastes in a Sanitary Landfill: Final Report" forthe Texas Low-Level Radioactive Waste Disposal Authority,February,, 1987.
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Yale' University
Byr f. ; Material bicense Number 06-00183-03
The following is submitted in response to NRC "Information
Required for Commission Approval of 3reatment or Disposal by.
Incineration" (revised. october. 3, 1979), in support of the request
by Yale University for renewal, in License No. 06-00183-03 (renewed-.
September 23, 1982), of authorit.ation of disposal of byproduct
material by incineration, pursuant to 10 C.F.R. S S 2 0.106 (b) ' a nd
20.302..
1. Isotopes to be incinerated.~
All isotopes covered by Yale University's broad license shouldbe included in the incineration approval. Illstorically Yale has
3 I4burned only animal carcasses containing the isotopes 11 , C,-
andf 995c. Since January 1981, animal carcasses containing only3 14
small quantities of 11 and/or C as specified in'Section
20.106 of=10 C.F.R. Part 20 have been burned.
A; computer code is-used by Yale's Radiation Safety Department to
-monitor ,-- a t any time, the fraction of MPC air that has been
attained. Prior to burning any carcass, the.quantitles of each
isotope are entered;intofthe computer code and an updated value of-
? .1 2_ i .-<<"'
being the calculated concentrationi~s computed, Cyi I~ N Ug
.
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fr m Appendix D, Tablebeing the MPC airof-isotope i and MPCg
II, Column I, of 10 C.F.R. Part 20.
is determined from the cumulative total ofThe quantity C3
isotope 1 (0 ) already disposed of by incineration'for the1
quarter plus .the quantity of isotope i under consideration f or ,
At the-disposal. Concentrations are averaged over a quarter year.
end of the quarter all cumulative Q 's are zeroed to begin thei
Th e r equ i r eme n t i s th a t h h.$ <.. ,i41next succeeding quarter. HI#-
as stated in Appendix D of 10 C.F.R. Pa r t 2 0. Typically
. $ ~ /- 0.5 is maintained f o r each quarter. Any intended burn\ \%'.\of a carcass which would contribute an extreme amount to the sum4 is disposed of through Yale's vendor. This occision
C /MPCi7 ffor isotope i for theis made by calculating the C /MPCgg
Because a quarter has M 91.2 5 days, a disposal byquarter.
incineration is generally not done if an individual carcass has
C /MPCi ) .01.This limits the daily 24 hour 3verage of
1
isotopes released}o4 MPC alr'Yale believes its estimates of release to the a tmosphere are
conservative for the following reasons:
I. ,,,C....'t_,.. 't O , t ' ,(11f 20. na )(
vl. Burning is halted f or the quarter when .
I
Rather than use the total daily discharge rate of the2.
stack, 10% of the discharge rate is used in our
calculations.
3. Concentration and C /(MPC air) g calculations arefcomputed at the stack exhaust, not a t the site boundary.
.
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4. If at the end of a quarter 4,0 .b.t.__ - g $has not been/ .
n MPC o\r /g(which is usually the c(ase), no credit f or this isreached
given in the next quarter or for the year. Each quarter is
treated independently irrespective of previous quarters..
2. Incinerator Characteristics.The incinerator, which is located at the Sterling Power Plant
of the Yale University School of Medicine, is connected to a 125
f oot stack, located approximately 120 f eet f rom the nearest
occupied buildings other than the power plant itself. This ataci
also serves several boilers, each of which is rated a t 380
horsepower. In the summer only one boiler may be operating.
The incinerator is conservatively estimated to burn over 1000
pounds of pape r trash per day, plus a minimum of 200 pounds of wet
biological waste per day. An average of 4 to 5 40-gallon drums o f
ashes are removed per day. It is estimated tha t the incineratoralone draws 100,000 cubic f eet of air per day. For one boiler plus
the incinerator (the minimum condition) the volume or extiaust air10 3 12
would be about 4.4 x 10 cm / day, or about 40 x 10
3cm / quarter year.
3. Concentration in. Effluent.The gaseous ef fluent will be maintained b'. low the MPC air by
controlling the amount of radioactive r aterial added to thecollects all radioactiveincinerator. The Radiation Saf ety Department
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-waste within the University and releases material to the
incinerator after the effluent concentrations are calculated asdescribed'in Item 1 above.
3 M* for a burn exceeds 0.01 the carcass isIf'the h iPId d ,lI h *
held _until a separate' burn may be mace, or if conditions warrant,
the carcass fa shipped'for ground burial utilizing a licensed f-vendor. The limit 0.01 is chosen because 1 day is 1/91.25 = %
.011 % .01 of a quarter. C is computed from the quantityg
' burned o using only-10% of the. incinerator flow rate, thusg
insuring that the 24 hour average does not exceed the requirement
$ ([ H P C ai d i.I .. . . . -- g,,, -for a mixture of isotopes..gg
8
4.- ALARA.
ALARA is being-practiced and conservatism is used in all
calculations,d O,' '- ,-
tot all1.- Although nermitted by law-to-have .- 'y ., " i
isotopes burned,-. Yale's practice does not allow ti.is figure,
to exceed 0.5. ,
2._ _ Only ---10% o f -- the --s tack e xhaus t rate is used in computing the-
average concentration, Cg..
3. Yale's computation averages over quarters rather than a one
| year-interval.- In addition,-no credits are carried from
one quarter.to the next. Each quarter is considered
irrespective.of past history, even if nothing was burned in
'a previous quarter.-
-4. Cor.centrations are computed at the, stack exhaust, _ not at -
the site boundary. -
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S. Residue in Ash.
Ash samples are analyzed using a set of calibration standardsin conjunction with a Gell system and MCA. Grab samples of severalhundred grams are taken of the ash and are ground into a
fine;powder.
A 50 to 60 gram sample is prepared and counted on the Gelisystem and the corresponding peaks identified. .
Using photopeak
efficiencies which are determined by uniformly spiking a typical50-60 gram ash sample (13 energy points used), the specific
activity of the ash sampic in a uCi/gm of each isotope isdetermined. It is assumed that 3 14H and C are completelyvolatilized and are not present in the ash. Isotopes which are
-
pure beta emitters or which have short half lives are not burneaI(i.e.1 4b 90 32Ca, Sr, P )' . Isotopes most commonly identifiedin the ash are in the form of microspheres and include 51 Cr,141 103Ce, Ru, 85c7, 111 In.
t. Handling and Disposal of Ash.
, Radioactive waste being sent tothe incinerator is controlled/
by the Radiation Safety Department, Precautions are taken by the,
incinerator operator'
to avoid exposure to. radioactivity in
carcasses or other waste streams and to avoid contact with theashes. Once a day the ashes are we tted down, removed ano placed indrums. The drums are then transferred to a sanitary landtill.
The instructions provided to the Radiation Safety Department
personnel handling the waste include a radiation safety seminar and
prolonged on-the-job training. The decision to incJ erate or not
rests with professional health physicists, two of whom are ,
'Certifled llealth Physicists. Incinerator personnel handling the
ash are instructed in chemical, biological and other hazards in
operating'the incinerator, in precautions to avoid contact withash, and in,piccedures to use (such as wetting) in handling the ash.
. Connecticut Depar tment of Environmental Protection Permi t.8.
Attached is a copy of the current Department of Environmental
Protection permit to operate the incinerator.
.
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9. Maximum ilumber o f Burns.-'
11 0 more.than two burns will be made per week, and no more than
-100. burns per year.4
The Medien1 ~ School incitierator has -been repaired recently and if dif ferent data becomesavailable, it will be forwarded at that time. The repairs should improve theUniversity's ability to incinerate.
4
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George Holeman '
.,
Department of Radiation Safety
I *
/ 16/87Yale University oate:
To: C P' C' 6
PLEASE: O Foryour approvalO Foryourreactionor
O Takesuitableaction recommendationY For your intormationO Reply directly to
O see(phone)me re the attached Retain or discard *
O Returntothisoffice O Fo*youtfilesO Forward to O PerourconversationO Send copies to O Asrequested
.
Remarks:
ytha c [ kJ / 0 7 7 7 b>
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Yale University,
Office of the Provost '
ATTN: Mr. Edward A. AdelbergDeputy Provost for the
Biomedical ServicesNew Haven, CT 06520 1.
Gentlemen:
This refers to your letter dated hovember 14, 1988, for an amendment to'Materials License 06-00183-03 to authorize changes in membership of the
Radiation Safety Committee.
An amendment fee of $120 is required as specified in 6170.31 (3L) of10 CFR 170, copy enclosed. Payment should be made to the U.S. NuclearRegulatory Commission and mailed to sy attention at our Washinoton, D.C.address,
,
t
Your application will be processed by the Region I Licensing staff l'located at 475 Allendale Road, King of Prussia, Pennsylvania 19406. The
fee, however, is required prior to issuance of the amendment. Whensubmitting the fee, please refer to CONTROL NUMBER 109892. c
L
l Sincerely,Sgt J by:
'
,
Gisda J3 ton --
Glenda JacksonLicense fee Mar.agement BranchDivision of Accounting and FinanceOffice of Administration and
Resources Management
Enclosure: ,h10 CFR 170 / -,5
W [y-cc: Region If\ 4W}P y.
Q0' ,
'ffh ,sf/[\
LDISTRIBUTION:W':Pending Fee.F11e2A.
ARM /DAF R/F;1LFMB R/F (2)DW/RI/ YALE UNIV
0FFICE: ARM /LFMB ARM /LFMBg!SURNAME: SKimberley: kb GJacksonDATE: 12/ 6 /88 12/ /88
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: (FOR LFMS USE): INFORMATION FRCM LTS
BETWEEN. .
:LICENSE F EE MANAGEMENT CRANCH, ADM : PROGRAM CODE: 01100
AND : ST ATUS CODE: 2/
C AT E GO R Y[3170 ? 3 03L EX 3L 2GREGIONAL LICEN5ING SECTIONS : FEE
DATE:,4: EXP.: FEE COMMEp S: 3L TEE FOR MILES LAB.::: ::: * ::: Y::::: * : :::::::::::::::::::
