- .- -- .--

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1 _ 2 PAGtsiI" -

| (5488'

U.t. NUCLE An citCULAT03Y COM%t$$10N PAGE oF

| MATERIALS LICENSE Amendment No 02 j| Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438),and Title 10, Il!

g Code of Federal Regulations, Chapter 1. Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations j!heretofore made by the licensee, a license is hereby issued authorizing the licensee to neceite, acquire, possess, and transfer byproduct,'g

'|,

Isource, and special nuclear matenal designated below; to use such material for the purpose (s)and at the place (s) designated below;toI jldeliver or transfer such matenal to persons authorized to receive it in accordance with the regulations of the applicable Part(s). Thist !Ilicense shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is :I

i

i

| subject to all cpplicabic rules, regulations and oiders of the Nuclear Regulatory Commission now or hereafter in effect and to any !Ijconditions specified below.i

' " ' * *In accordance with application dated |

| January 22, 1988,j:I

|!

jl-i International Biotechnologies, Inc. 3. Ucense number 06-21254-01 is amended ini its antirety to resa as follows: I

'

1 2. p,0,- Box 9558 !g 'II

I,

|1I New Haven, Connecticut 06535 4. Expiration date January 31, 1994 | ||

|| her*en$ No 030-20106 I

4

I 6. Byproduct, source, and/or 7, Chemical and/or physical 8, Maximum amount that licensee |I special nuclear material form may possess at any one time Iunder this license

| A, Hydrogen 3 A. Any A. 10 mil 11 curies l ''

i .B. Carbon 14 B. Any B. 10 mil 11 curies || C. Phosphorus 22 C. Any C. 10 millicuriesI D. Sulfur 35 D. Any D. 10 mil 11 curies il a

iI 9. Authorizec useI I

, 1

| A. through D. ForresearchanddevelopmentasdefinedinSection30.4(q)of10CFR [gi l

I| | Part 30.1 I , j

il !| | CONDITION 5 !I'

| |Il 1

| 10. Licensed material shall be used only at 25 Science Park, New Haven, Connecticut. '

f[ q

- ! ~11. A. Licensed material shall be used by, or under the supervision of,| Douglas L. Vizard, Ph.D.I

g '

I '

I B. The Radiation Safety Officer for this license is Douglas L. Vizard, Ph.D. I1I

| 12 Licensed material shall not be used in or on human beings. fI

i 13. The licensee is authorized to hold radioactive material with a physical half- !gI

i life of less than 90 days for decay-in-storage before disposal in ordinary|1

I trash provided: fI

j|Ij| A. Radioactive waste to be disposed of in this manner shall be held for|

i decay a minimum of 10 half-lives,k

i B. Before disposal as normal waste, radioactive waste shall be surveyed to ) Ul determine that its radioactivity cannot be distinguished from background. t &'I All radiation labels shall be removed or obliterated. I *

9002160036 090206 % |I RE01 11C30 \I 06-21254-01 PM '

+J. _______________0FFICIAL RECORD COPY RJ)

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____________________________________

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AC Form 374A U.S. N A3 GRULATcRY COIMelStlON _ pg p y p ,, g, n

Lac:n.e riumter.

"

MATERIALS LICENSE 06-21254-01 j" * ' " "" ""# '

SUPPLEMENTARY SHEET i030-20106 j

l

Amendment No. 02,

. ;

l(Continued) CONDITIONS,

14 Except as specifically provided otherwise in this license, the licensee shallconduct its program in accordance with the statements, representations, andprocedures contained in the documents including any enclosures, listed below.The Nuclear Regulatory Connission's regulations shall govern unless thestatements, representations and procedures in the licensee's applicationand correspondence are more restrictive than the regulations.

. A. Application dated January 22, 1988.

. B. Letter dated October 22. 1988 !C. I.etter dated December 16, 1988

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For the U.S. Nuclear Regulatory Commission

Original Signed By:FEB 061989 8, 3en o. xinnernonDate

_

Nuclear Materials Safety BranchRegion IKing of Prussia. Pennsylvania 19406

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.______________.--____________--__--------------er.ir-w

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FEB 061989

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License No. 06-21254-01Docket No. 030-20106 -

Control No. 108352

International Biotechnologies, Inc.ATTN: Darlene W. bianca

Radiation Safety OfficerP.O. Box 9558New Haven, Connecticut 06535

,

Gentlemen: i

;

Pleaso find enclosed the renewal of your NRC Material License.,

Please review the enclosed document carefully and be sure that you understand !all 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. i

'Picase be advised that you must conduct your program involving 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 for Materials-Licensees." .

Your letter dated December 16, 1988 included details of your proposed ,

relocation of radioactive material use areas as well as information concerningyour plans to decontaminate and decommission your present facilities. 10 CFR30.36(d)(1) requires that each licensee, prior to release of 'a restricted area i

for unrestricted use, submit to the NRC, a radiation survey report to confirmthe absence of radioactive materials or to establish the levels of residualradioactive contamination. The licensee shall, as appropriate:

a. Report levels of radiation in units of microrads'por hour of beta andgamma radiation at one centimeter and gamma radiation at one meter.

~

Report levels of radioactivity in units of disintegrations per minute (ormicrocuries) per 100 square centimeters removable and fixed on surfaces.

b. Specify the survey instrument (s) used and certify that each instrument isproperly calibrated and tested.

If no residual radioactive contamination attributable to the activitiesconducted under the license is detectable, then you must submit acertification that no removal radioactive contamination was found. If the !

'submitted information is adequate, the NRC will notify you in writing, thatthe facility may be released for unrestricted use.

OFFICIAL RECORD COPY ML 06-21254-01/LTR 0001.0.0g gg 01/17/89

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If residual radioactivity is detected, the licensee must continue to controland limit access to the restricted area and :ontinue efforts to reduce theremaining level of radioactivity to less than the levels specified in" Guidelines for Decontamination of Facilities and Equipment Prior to Releasefor_ Unrestricted use or Termination of Licenses for Byproduct, Source, orSpecial Nuclear Material" (copy enclosed). Upon reduction of residualradioactive contamination to levels less than those specified in thisdocument, you must certify to ti.e NRC that the facility is ready to releaseto unrestricted use. If the submittei information is adequate, the NRC willnotify you in writing, that the #acility may be released for unrestricted use.

Since serious consequences to employees and the public can result from failureto comply with NRC requirements, the NRC expects licensees to pay meticulousattention 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,and representations made in your license application and supplementalcorrespondence with NRC will result in prompt and vigorous enforcementaction against you. This could include issuance of a notice of violation,or in case of serious violations, an imposition of a civil penalty or an

,

order suspending, modifying or revoking your license as specified in the (General Policy and Procedures for NRC Enforcement Actions,10 CFR Part 2,Appendix C.

,

We wish you success in operating a safe and effective licensed program.

Sincerely,

Original Signed By:

John D. Kinneman

John D. Kinneman, ChiefNuclear Materials Safety Section BDivision of Radiation Safety

and Safeguards

Enclosures:1. Amendment No. 022. Requirements for Materials Licensees3. 10 CFR Parts 2, 19, 20, 30 and 1704. Regulatory Guide 0.75. Guidelines for De ontam ation of Facilities and Equipment

DRSS: rig >h/pmb- RI

Pelchat/mj .inneman

1////89 1/)>#/890FFICIAL RECORD COPY ML 06-21254-01/LTR - 0002.0.0 ,

01/17/89

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O O s- AInternational Bioteetmologies, Inc. ,.s i

as ademo. Powk 6 .

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new unvem,cressasTelepheme:(sos)'res.aeoo

FAX:(tos)ese eles,

16 December 1988 -

John D. Kinneman, Chief';

Nuclear Materials Safety Section BDivision of Radiation Safety and SafeguardsU.S.N.R.C.,- Re vion I475 Allendale loadKing of Prussia, PA 19406 *

RE: Mail Control No. 108352

Dear Mr. Kinnemam '

,

This is in response to your 19 November 1988 letter, requeetingfurther details supporting our application (License No. 06 21254-01). Your notations called for revision of items 4-6 in my 24October 1988 letter su1portin; the application. The revised itemsare attached, labeled "leviset Ap11ication", and are presented in '

triplicate, where the third copy ;mighlights significant changesmade.

Thank you for forwarding to me the copies of regulations that you |deem applicable. Actually I had accessed some of these materials ;but. thought that there might be a catagory of usage that may be !lower in level than that deemed necessary for " medicalinstitutions". Our highest level of contamination that we have lever assessed in user instruments known to be contaminated do not J

~

approach the contamination levels cited in regulatory guide 8.23.While we will make every attempt to adhere to your criteria,1 -iappeal to the NRC- to create a category for a lower level of usage '

that might involve less administration and labor to monitor i

contamination levels. ]

| In item #1 of my 24 October 1988 application, I cited that ourL laboratory premises (user areas will be relocated to the newly !

renovated second floor of 25 ) Science Park (the floor below ourI

present facility). The safety consulting firm that we retained is !advising us to apply a self-consistent set of " OSHA" based safety l

regulations to our laboratory area, with a considerable increasein . radiation safety measures. Hence, the resulting radiation |safety rules that will be effective will be considerably more |

elaborate than this application implies. I fully realize that |your office must receive notice of the pending move, as well asthe plan that accomodates the "decommissionmg"l noticeof our present

=

space. Please accept this reminder as a forma of ourL intentions, and please notify me immediately if the plan| presented below is insufficient to effect the move and

decommissioning of our present facility, fbbN

The Cutting Edge of Moleculor Biology S.

DECi .-

OfflCIAL RECORD COPYRij

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AMMENDMENT TO NhtC LICENSE #06 21254 01 (RE: Restricted Area)Effective Date: The time frame for becoming operational in thenew facility is late January 1989.

New location: The East wing of the Second Floor of 25 SciencePark, New Haven, CT. Ttus location is newly renovated wetlaboratory space, directly below the current facility. The newfacility floor plan is identical to the previous floor plan; theuser areas and amount of usage is relatively unchanged. The newfacility floor plan is attached. Two significant changes in thefloor plan are the designated limit of the restricted area, whichwill be defined by a security (card access) door, and theposition of the radioactive waste, which will be in a dedicatedcloset.

Movement of Radioactivity: All current e that may becontaminated will be prequalified for " release'quipmentby our usual wipetest and according to action levels designated in RegulatoryGuide 8.23, Sect. 2, Table 3. Designated storage containers andrefrigerators will be maintained for that same purpose in newuser areas; hence, no decommissioning of storage containers andrefrigerators is planned. Movement of these items will bedirected - by the RSO and through the restricted area only (anelevator commutes the old and new restricted nicas). The singularradioactive source is the internal standard of the LSC; itsmovement will be contracted through the vendor of the maintenancecontract.

Decommissioning of Restricted Area: The vacated area will bethoroughly assessed by wipe tests to qualify the area for release

Sect. 2,g to action levels designated by Regulatory Guide 8.23,-

accordm

place by the Science Park Development Corporation (owner) y inTable 3. No usage, nor renovation p ans are entrentl ,

for thearea to be decommissioned.

I thank you for your cooperation and advice.

Sincerely, y

h6 '

Douglas L, Vizard, Ph.D.bRSO, Director of Research, International Biotechnologies Inc.

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1. The RSO assumes total responsibility for radioisotope3

administration, including'

a. Order originationb. Receipt and monitoring

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c. Storage and diasemination ,

d. User monitoring and education '

e. DisposalThe RSO responsibilities at IBI have been assumed by Dr. DouglasVizard exclusively theassisted by personn(el under his direct supervision.NRC office was notified 6/88), who isDuring themonths of November and December of 1988, the laboratory premisis(user areas will be relocatedpersonnel a)nd delegating some, and the RSO will be retrainingof the above responsibilities toaccomodate changing pohcies necessitated by the relocation.

As a state nent f a thority, this supplement is hereby witnessed:A Q4- \ .t- m

Martin MatTessich, Wes1 dent IBI

2. a. A sin};le calibration source is regularly used. It is asealed cocktail of 3 H, Packard K0203, hsted at 135,800 dpm, May1966. Current readings sonsistent with 40% counting efficiency.Packard # 167 Background Standard also used. Occasionalverification of diluted radioisotope shipments from vendors alsoused to check self consistency.

b, Listed

17.6 nCi. 135,800 dpm 3 H, May 1966 indicates contemporaryc. Original manufacturer's assurance,d.1. Pre set 3 H Channel counting of standard (see 2.a.) for

valid one minute data point as epm' ecremented standard2. Comp (arison to properly d usin

lambda) = 1.061x10 7 per min. Typ,cally, g 3 Hdecay con,stantt-

-

40 %efficiency is reported.'

e. The RSO, Dr. Douglas Vizard, performs calibration at afrequency of greater than monthly. Quahfication apparent in CVattached to application.

3. While hand held survey meters are available for such an '

application, no organized procedures are deemed necessary.Maximum single usage of any isotope is less than 50 micro Curies. .

No plans to increase usage.'

.

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REVISION OF APPLICATION 16 December 1988.

4. Procedures for Radioisotope Administrationa. Ordering and Receiving:

i 1. All orders for radioactive material are initiated by theRSO only.

2. All radioisotope orders are received by a designated|

Receiving Person, equipped with a yrsonal badge U3 andi

immediately delivered to the laboratory of the RSO for sur(vey),and7! storage.I b. Incoming Radioisotope Monitoring

1. Laboratory garmets and2. Survey meter activated. gloves are standard practice.3. All packaging materials localized on user bench.4. Container

removed, wiacd with sampling (disc multipletimes, different layers, incluc ing final seal without ,

disrupting).5' Wipe disc immersed in liquid scintillant and counted for

'

one minute by 3 channel LSC assay. See section 6.e. below.Results are recorded, attached to the vendors certificate ofanalysis and filed by the RSO.

| 6. Action levels less than those stated in Table 3 ofl Section 2 of Regulatory Guide 8.23 are deemed acceptable.

7. If unacceptable, analysis of type and location ofcontamination and vendor notification is planned. Never needed toexecute.

8. Material entered as inventory and stored frozen in samearea (laboratory of RSO).

c. Laboratory traininsponsored by the RSO. g seminars have and will continue to beThe RSO also happens to be responsible forall assay development in theusage, therefore personally directm,pany invoMng radioisotope

comg an new usage of

radioisotopes minimizing the amount - used). y Training sessionsinclude a bas (ic introduction to nuclear physics, radiobiology,relative risk assessment and assay techniques. Virtually all 131laboratory personnel have had previous user experience as well asradiation program exposure in previous academicinstitutions. protectionOther Radiation Safety programs are s sonsoredlocally and teaching consultants identih_ed should that be ceemednecessary for inexperienced personnel.

d. See attachment. This document is agreed upon by all users,and is posted in all user areas.

5. While our lowlevel usage (see Section 3, above does notdemand elaborate emergency plans, all users have imme)diate accessto the RSO during working hours. Necessary decontaminationmeasures of areas or personnel will be immediately administered '

by the RSO. ,

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9 9

150 RADIATIC05 OAFETY RULES

1, Prepare and label area for Radioactive work prior to handlingradioactivity. C'learly label all containers and areas whereradioactive material is to be used.

2. No ingestion of food or drink, no storage of food, nothing by mouth,and no mouth pipetting in any laboratory within the controlledlaboratory area at IBI, whether or not radioactivity is used or stored j

'

within a particular laboratory,

3. Wear lab coats, specified lab shoes / shoe covers, gloves, and filmc

| badges for all radioactive applications and in all laboratories where ,

radioactivity is generally used.[

4 Isotopes may be requested only through the Radiation Safety Of ficer,and are stored and disseminated only at that location (R&D Lab).

| Dispensing of the isotopes from primary storage containers shall -

occur only in the provided area adjacent to the specified storage

|- freezer. Upon removal of any isotopes from the specified freezer: ;

j A. allquot into a sealed container (microfuge tube)'

B. record the amount removed in log book immediatelyo

C. secure the primary storage container, and return to freezerD. promptly return to prepared experimental location.

5. Sign in for scintillation counter use, indentify vial locations bynumbers, remove vlais when complete, and discard vlais.appropriately.

|

6. Separate solid and 11guld waste, and segregate 32p,35 , HC and H.S 3o

Store any tempory waste containers behind available plexiglassshleid or in a metal cabinet. Transfer all waste to designated wastefacility immediately upon the completion of your experiment. ;

7. It is recommended that the experimental area be appropriately j

| monitored immediately af ter waste removal and general cleanup. '

Refer all questions to the R&D Laboratory. Violation of any of the jabove rules will be treated as a violation of General LaboratorySafety Rules.

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REVISION OF APPLICdTION 16 December 1988'

6. a. Wipe surveys are the responsibility of the RSO and/or hisassistant. Such surveys are performed m all user areas by drydise wipes of 100 sq. cm. areas and assessed by liquidscintillation counting.

b. Complete mans and descriptions of user areas are available;these include incide^ntal, user, storage and waste areas. Wipesare executed (6.a.), data is recorded and kept on file by theRSO. Reportsthe IBI Safety Co(including personnel exposure data) are issued tommittee monthly,

c. User area wipes are performed and reported monthly. Usersare encouraged to survey individual areas after each usage,

d. Decontamination may be directed should a user area wipetest significantly exceed action levels suggested by RegulatoryGuide 8.23 (Section 2, Tables 2 and T). Any other significantcontamination is attended to inimediately,

c. All wipe assays are recorded as 3 channel epm from LSCoutput. Where an action level significantly exceeds background,the assay is iepeated to attain counting -significance and

converted to dpm for comparison to establis1ed criteria (d, the6.d.).Wiiere action levels do not significantly exceed backgrounmaximum sensitivity of the assay are reported in units of dpm.

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1.e The RSO-. - assumes total responsibility for- radioisotope; administration, including

a. Order originationb. Receipt and monitoring '

c. Storage and disseminationd.- User monitoring and educationc. Disposal

- The RSO responsibilities at IBI have' been assumed by Dr. DouglasVizard exclusively (the NRC office was notified 6/88), who isassisted by personnel under his direct supervision. During themonths' of November and December of 1988, the laboratory premisis

-(user areas) will be relocated, and the RSO will be retrainingpersonnel and delegating some of the above responsibilities toaccomodate changing pohcies necessitated by the relocation.

As a state ent f a thority, this supplement is hereby witnessed:\ A Qe% \ ,t- m

Martin Matlessich, Wesident IBI-

2. a.' A single calibration source is regularly used. It is asealed cocktall of 3 H, Packard K0203, hsted at 135,800 dpm, May

~

1966.1 Current readings sonsistent with 40% counting efficiency.Packard #167 Background .rd also used. Occasional

"

' verification , of diluted radioisoto - pments from vendors alsoused to check self consistency.

b. Listed 135,800 dpm 37 say 1966 indicates contemporary17.6 nCi.

c. Original . manufacturer'* nee.d.1. Pre set 3-H Chan anting of standard (see 2.a.) for-

valid one: minute data point .pm.2.- Comparison to properly decremented standard, using 3 H

' decay constant (lambda) = 1.061x10-7 per min. Typically, 40%efficiency is reported.

e. The RSO, Dr. Douglas Vizard, performs calibration at afrequency of greater than monthly. Quahfication apparent in CVattached to application.

3. While . hand held surve are available for such anorganized y metersprocedures - aredeemed necessary.application, noMaximum single usage of any isotope is less than 50 micro Curies.No plans to merease usage.

.

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131 RADIAT1000 SAFETY RULES1

.

1. Prepare and lab,el area for Radioactive work prior to handlingradioactivity. Clearly label all containers and areas where -radioactive material is to be used.

2. No ingestion of food or drink, no storage of food, nothing by mouth,and no . mouth pipetting in any laboratory within the controlled

.

laboratory area at IBI, whether or not radioactivity is used or stored |within a particular laboratory.

3. Wear lab coats, specified lab shoes / shoe covers, gloves, and film j

badges for all radioactive applications and in all laboratories whereradioactivity is generally used.

4 Isotopes may be requested only through the Radiation Safety Officer,and are stored and disseminated only at that location (R&D Lab).Dispensing of the isotopes from primary storage containers shall ;

occur only in the provided area adjacent to the specified storage,,

freezer. Upon removal of any isotopes from the specified freezer: jA. allquot into a sealed container (microfuge tube)8. record the amount removed in log book immediatelyC.' secure the primary storage container, and return to freezer

_

D. promptly return to prepared experimental location. y

l5. Slgn In for scintillation counter use, indentify vial locations by 1

numbers, remove vlais when complete, and discard vialsappropriately.

)6. Separate solid and liquid waste, and segregate 32p,35S, MC and H.3

Store any tempory waste containers behind available plexiglass j

shield or in a metal cabinet. Transfer all waste to designated waste :

facility immediately upon the completicn of your experiment. ;

7. It is recommended that the experimental area be appropriately |monitored immediately af ter waste removal and general cleanup. 1

Refer all questions to the R&D Laboratory. Violation of any of theabove rules will be treated as a violation of General LaboratorySafety Rules.

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? REVISION OF APPLICdTION 16 December 1988

- 4.- Procedures for Radioisotope Administrationa. Ordering and Receiving '

1. All orders for radioactive material are initiated by theRSO only.

2. All radioisotope orders are receivedby'dge

a designated !Receivina Person, equipped with a wrsonal ba U3 andimmediaIely delivered to the laboratory of the RSO for sur(vey),and |storage. -

b. Incoming Radioisotope Monitoring ;

1. Laboratory garmets and2. . Survey meter activated. gloves are standard practice. !

3. All packaging materials localized on user bench.4. Container removed, wi xd

with sampling (disc multipletimes, different layers, incluc ing final seal withoutdisrupting).

5' Wipe disc immersed in liquid scintillant and counted forone minute by 3 channel LSC assay. See section 6.e. below.Results are recorded, attached to the vendors certificate ofanalysis and filed- by the RSO.

6. - Action levelsrlesso than those stated * in DTable 73. of"Section~2Tof Regulatory . Guide- 8.23"are deemed' acceptable.' '

'

7. 'If' unacceptable, analysis of type and location ofcontamination and vendor notification is planned. Never needed toexecute.

8. Material entered as inventory and stored frozen in samearea (laboratory of RSO).

c. Laboratory traininsponsored by the RSO. g seminars have and will continue to beThe RSO also happens to be responsible forall assay development in theusage, therefore , personally directm,pany involving radioisotope

comg an new usage of

radioisotopes (minimizing the amount used). y Training sessionsinclude a basic introduction to nuclear physics, radiobiolo5,relative risk assessment and assay techniques. Virtually all ISIlaboratory personnel have had previous user experience as well asradiation progrhm exposure in previous academic. institutions. protectionOther Radiation Safety programs are s aonsored ,

locally and teaching consultants identified should that be ceemednecessary for inexperienced personnel. -

d. See' attachment. This document is agreed upon' by all users,f and'is' posted Lin all userrareas.

5. While our low level usage (see Section 3, above does notdemand elaborate emergency plans, all users have imme)diate accessto' the RSO - during working hours. Necessary decontaminationmeasures of areas or personnel will be immediately administered '

by the RSO.

__ _ _ - _ - _ _ _ __. - . . -.

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O I

REVISION OF APPLICATION 16 December 1988.

.

6. a. Wipe surveys _are the' responsibility of the RSO and/or hisassistant.

Such surveys are performed m all user areas byf"; dry ~id,

. disc. wipes. of s 1100. 'sq. cm.T " areas and assessed by liqu' scintillation counting.

b. Complete maps and descriptions of user areas are available;these incluc:e incidental,. user storage and waste areas. Wipesare executed (6.a.), data is , recorded and kept - on file by the .

-RSO. Reportsthe IBI Safety Co(including personnel exposure data) are issued tommittee. mon ,

c. User area wipes are ~ ormed and reported monthly? Userstare encouraged to survey indi dual areas after each ' usage.

-- d. Decontamination maye be directed should a user area wipetesti significant exceed action levels suggested by Regulato .Guide 8.23 ection 2, Tables ; 2 and 3contamination (is attended"to!immediately.' ) Any other signiicant-''

e. "All wipe assays 'are recorded as 3-channel epm from LSC-output? . Where an action- level significantly exceeds" background,

L the ' assay is repeated to attain", counting significance and.converted 'to 'dpm for" comparison to: establis1edv eriteria " 6.' .).

'Wh'ere~actiori L Ievels do :not " significantly exceed backgroun(d;' the"d

.

maximum sensitivity of the assay are reported in units of dpm. .

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OfflCIAL RECORD COPY,M 1)

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License No. 06-21254-01 1

"-Docket No. 030-20106Control No. 108352 ;

Idternational Biotechnologies, Inc. '

: ATTN: Douglas Vizard, Ph.D.-Radiation Safety Officer

P.O. Box 9558New Haven,-Connecticut 06535

Gentlemen:

This is in reference to your application dated January 22, 1988 and your -

subsequent letter dated October 22, 1988, for the renewal of License No.06-21254-01. In order to continue our review, we need the following additionalinformation:s

1.. Item 6 of the 1etter dated October 24, 1988, states that an action level."2X background (50 cpm)" has been established for the evaluation ofpackage receipt contamination surveys. Item 6.3 of the same' letterstates that "all wipe assays are recorded as 3-channel cpm.from LSCoutput." The use of "2X background" as an' action limit and " cpm" as

= units is unacceptable since they are subject to variations in countingbackground and counting equipment performance and can not be directlyrelated.to an; actual measured physical quantity.

Item 6.e of our-letter dated July. 26~,1988, specifically states that thecresults of contamination surveys must be recorded and evaluated in unitsor subunits of curies or disintegrations per minute. This requirement is .!designed to permit a licensee to evaluate the results of their surveys in

~

terms of a real physical unit and to directly compare these result's to,

the values established in 10 CFR 20 for radiological protection. '

Table 2 of Regulatory Guide 8.23, " Radiation Safety Surveys at MedicalInstitutions" establishes suggested action limits for variouse ,

radionuclides. These limits are considered acceptable to the NRC-stafffor the type of operations conducted under your radioactive materiallicense'. It is necessary for you to revise your radiation survey andevaluation procedures to' include the use of physical units and establish' action limits in these units. A copy of Regulatory Guide 8.23 isenclosed.

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0FFICIAL RECORD COPY ML 603 - 0001.0.0

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International Biotechnologies, Inc. -2-

2. Item 4.d. of your letter dated October 24, 1988 established _ InternationalBiotechnologies Radiation Safety Rules for the safe handling ofradioactive material. These rules fail to specifically prohibit thepractice of mouth pipetting when handling radioactive material. It willbe necessary for you to submit revised laboratory safety rules whichspecifically prohibit the practice of mouth pipetting of radioactivematerial.

3. Item 6 of your letter dated October 24, 1988 states the RSO will performquarterly contamination surveys and that users of radioactive materialwill be encouraged to perform radiation use area surveys af ter each use.It is necessary that radiation use area surveys be~made at leastmonthly. It is suggested that you closely review the survey frequencyguidelines established-in Regulatory Guide 8.23 (Section 2 and Table 1).It is necessary for you to submit revised laboratory radiation surveyfrequencies.

We' will continue our review upon receipt of this information. Pleasereply in duplicate to my attention at the Region I office and refer toMail Control No. 108352.

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,

L Original Signed By:

Francis M. Costello

/ ohn D. Kinneman, Chief

-) Nuclear Materials Safety Section BDivision of Radiation Safety

and Safeguards

Enclosures:L 1. Regulatory Guide 8.23'

2.- 10 CFR 19 -

3. 10 CFR 204. NRC Letter dated July 26, 1988

bec: J. Pelchat, RI~

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Dr.. John E. Glenn .

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' Nuclear Materials-Safety Section B. Division of Radiation Safety and Safeguards ]. U.S.N.R,C.- Re ion I.-475 Allendale oadKing of Prussia, PA 19406 -

L Dear Dr. Glenn,

Enclosed is the requested information supporting the application renewal of license# 06 21254 01.

IThis is in response to your October 14,1988 communication where you state that it' '

was a second notice. The first notice' of July 26,1988 was not received by me, nor

was a copy of "10 CFR 19". I would be happy to receive that copy,I am dismayedas well as any~

material that directly relates to " low level" usage of radioisotopes. .Ia.

'

J :that I have wasted time and money in the past year. trying to obtain clear policy

statements. directly relating to low-level usage.Licensinu ~Renorts useless, and have cancelled my subscription. . publication Nuclear.

I found the|-I would be greatful

if you could'be helpful in this matter. 11

Sincerely,-'

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E : Douglas Vizard, Ph.D. - RSO I

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0FFICIAL RECORD COPY ML 1028 00T 198j '

The Cutting Edge ofMolecular Biology ISI,

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1. The RSO assumes total responsibility for radioisotopeadministration, including

a. Order originationbi Receipt and monitoringc. Storage and disseminationd. User monitoring and educatione. Disposal

The RSO responsibilities at IBI have been assumed by Dr. DouglasVizard exclusively (the NRC office was notified 6/88), who isassisted by personne! under his direct supervision. During themonths of November and December of 1988, the laboratory premisis

will be relocated, and the RSO will be retraining(user - areas) d delegating some of the above responsibilitiespersonnel an toaccomodate changing policies necessitated by the relocation.

f adthority, this supplement is hereby witnessed:.As a statement

..<d -+ \ 9mMartin Mattessich, President IBI

,

2. a. A single calibration source is regularly used. It is asealed cocktail of 3 H, Packard K0203, hsted at 135,800 dpm, May1966. Current readings sonsistent with 40% counting efficiency. :Packard # 167 Background Standard also - used. Occasional-verification of ' diluted radioisotope shipments from vendors alsoused to check self-consistency. .

b. Listed - 135,800 dpm 3-H, May 1966 indicates contemporary17.6 nCi.

c. Original manufacturer's assurance.d.1. Pre set 3 H Channel counting of standard (see 2.a.) for

valid one minute data point as e m.2. Comparison to proper

decremented standard, using 0%3-H

decay constant (lambda) = 1.0 x10-7 per min. Typically, 4efficiency is reported.

e. The FLSO, Dr. Douglas Vizard, performs calibration at afrequency of greater than -monthly. Qualification apparent in CV '

attached to application.i

i3. While hand held survey meters are available for such an,

application, no organized procedures are deemed necessary.Maximum single usage of any isotope is less than 50 micro Curies.No plans to increase usage.

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4. Procedures for Radioisotope Administration 1

a. Ordering and Receiving '

1. All orders for radioactive material are initiated bythe RSO only. *

2. All radioisotope. orders are received by a designatedReceiving Person, equip ped with a personal badge U3, animmediately delivered to the laboratory of the RSO for surv(ey-)and ,

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storage.~ b. Incomin.; Radioisotope Monitoring

1, Laaoratory garmets and gloves are standard practice.2. Survey meter activated.3. All packaging materials localized on user bench.4. Container removed, wiped with sampling disc multiple

- times, different layers, including final seal, without disruptingseal. j

5. Wipe disc immersed in liquid scintillant and counted jfor 1 minute on open channel, accomodating all regular isotopessimultaneously. Recorded, attached to certificate of analysis andfiled by RSO.

6. Less than 2x background (50 cpm) deemed acceptable, e.67. If unacceptable, analysis of ty and location of

l- contamination planned, and vendor notified.pe Never needed toL execute.L. 8. Material entered as inventory and stored frozen ing same area (laboratory of RSO),

c. Laboratory training seminars have and will continue to be'

I sponsored by the RSO. The RSO also happens to be responsible for!. - all assay development in the company involving radioisotopeL usage, therefore personnaly directmg any new usage of *

radioisotopesa bas (icminimizes the amount used). Trainin,; sessions'

include introduction to nuclear physics, radicaiology,o relative risk assessment and assay

techniques in(theRSO is

[ educated, has taught and has done research all of these- areas). No instances of totailly inexperienced users havearisen, but should that be the case, that individual will undergo ,

extensive personal training, including demonstrations. Virtually Iall IBI laboratory personnel have had previous user experience aswell as

institutions. protectionradiation program exposure in previous

academic Other Radiation Safety programs aresponsored locally should that be deemed necessary. A copy of10CFR19, as well as any other information on low level usage willbe appreciated and distributed as educational material if sent to -

the RSO (see cover letter).d. See attachment. This is a signed document by all users,

and it is posted in user areas.

5. While our low-level usage does not demand elaborate emergencyalans,= all users hcve immiate access to the RSO during working1ours. Decontamination measures of areas or personnel will beimmediately administered by the RSO.

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Radiation Safety Rules. .

1. Prepare and label area for. Radioactive work prior to handling radioactivity.Clearly label all containers and areas where radioactive material is to be used,

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2. No'esting, drinking, smoking or storage of food in any lab where radioactivityis utilized or stored.

3. N' ear lab coats, gloves, and film badges for all radioactive work;

4. Upon removal of any isotopes from the freezer, record the amount removed forthe experiment in the log book immediately. j

5. Sign up when using scintillation counter indicating slot #'s used. Remove. vials Iwhen counting is completed and dispose of properly.

6. Separate ' solid and liquid waste, as well as asp and ass and sH.. Store ;

temporary waste containers behind plexiglass shield on absorbant padding.

Violation- of- any of the- above rules will be treated as a violation of General,

' Laboratory Safety Rules,

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6. a. ~ Wipe surveys are the responsibility of the RSO and/or hisassistant. Such surveys are performed in all user areas by discwipes and assessed by liquid scintillation counting,

b. Complete maps and descriptions of user areas are available;these include incidental, storage and waste areas. Wipes are 1

Safety Co(in(6.a.),executed data is recorded and kept on file by RSO.Reports cluding personnel exposure data) are issued to the IBI

mmittee monthly / quarterly, formedUser area wipes are per and reported quarterly.c. ,

Users are encouraged to survey mdividual areas after each usage. '

d. Decontammation may be directed should a user areasignificantly exceed twice background. Although- this may seem,

unusually stringent, it will be applied to areas of repeatedassay utilizing an extremely low-level of isotopes, for the sakeof qualit assurance.- This policy has never needed to beexecuted. y

e. All wi assays are recorded as 3-channel epm from LSCoutput. These perecords are maintained by the RSO/ Assistant.

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License No. 06-21254-01,

Docket No. 030-20106'

. Control No. 109077

.

..International Biotechnologies Incotporated

M 275 Winchester AvenueNew-Haven, Connecticut 06535 '

'' SUBJECT: APPLICATION FOR MATERIAL LICENSE RENEWAL DATE0 January 22, 1988,

'AND OUR REQUEST.FOR ADDITIONAL INFORMATION DATED July 26, 1988

-

Gentlemen:

This refers to your request for. renewal-of your license. A check'of our files| = indicates that we have not received a response from you to date. If we do not- L

receive a-reply within 30 days, it may be necessary to deny your applicationand terminate your license. Such action would require that you divest yourself :

,

of all licensed material.'

Sincerely,i

Original signed By:John E. Glenn, Ph.D.

John E. Glenn, Ph'D., ChiefNuclear Materials Safety section B o

Division of Radiation Safetyand Safeguards

Enclosure: Letter. dated July 26, 1988,

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"' -Lic'ense No. 06-21254-01-

Docket No. 030-20106-

Control No. 108352L

In'ternational' Biotechnologies, Inc.ATTN: Darlene W. Bianca, RSOP.O. Box 9558 *

New Haven, Connecticut 06535.

'

Gentlemen:>

This is in reference to your application dated January 22, 1988 to renew,

License Number 06-21254-01. In order to continue our reviev, we need the*

,

following additional information: J

1~ 'The application fails to describe the responsibilities of the radiation 'Isafety. officer. Please submit a description of the RS0's duties and<

a statement of authority to carry out these duties. '!4

2. Item 11. of the-application fails to describe the calibration program.for-the liquid scintillation counting system. The procedure should includu

.the following information:,

a. The' manufacturer and model number'of the calibration sources. !

b. The nuclide and quantity of radioactive material incthe sources.

f .c. The' accuracy of the sources and how determined. 1

; d. The step-by-step procedures used in the calibration of the liquidscintillation system.

i,- ,

e. -The. names and pertinent experience of the' persons who will? performthe calibration. '

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3. . Item 12. of the application fails to describe.what provisions have been 'lmade for monitoring extremity radiation exposure. It will be necessary i

that extremity exposure monitoring devices be provided to-individuals any~

' time they handle greater than 1 m1111 curie of phosphorus-32 at a time.|Please confirm that the use of such devices will be required.under these' circumstances.

4. The application fails to include a description of InternationalBiotechnologies, Inc.'s radiation protection program. Please submityour radiation protection procedures. It will be necessary thatthe procedures include the following information:

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a.- Procedures for ordering and receiving radioactive material. Theseprocedures should be adequate to ensure that responsible persons are-notified upon receipt of radioactive material and that radioactivematerials are secured against unauthorized individuals. It ispreferable that all radioactive materials be received-in one

,

location so that they may be reliably accounted for and surveyedpromptly.

b. Procedures for examining incoming packages. The procedures may varydepending on the quantity and type of radioactive material received,but should be least include instructions for surveying packages,wearing gloves while opening packages and checking packing . materialfor contamination,

c. A description of training required for laboratory personnel who areinvolved with the use of radioactive material and for ancillary *

personnel who might enter areas where radioactive materials are usedor stored. The training program should be sufficient-to meet therequirements of 10 CFR 19.12 and to ensure that all personnel areknowledgeable in radiation safety training and techniques pertinentto their duties. A copy of 10 CFR 19 in enclosed for your informa -tion,

d. A copy of general instructions to be followed by personnel workingwith radioactive material. These instructions should address thefollowing: j(1) The use cf laboratory coats, gloves and other appropriate

protective clothing.x

(2) Instructions to wear radiation exposure monitoring devices.,

(3) . Procedures for the transfer of radioactive material betweenlaboratories.

L* (4) Proper radioactive waste storage and disposal procedures.

(5) The procedures for and' frequencies of radiation surveys.

(6) Prohibition of mouth pipetting.

(7) Prohibition of eating, drinking, smoking, or applying cosmeticsin radiation use or storage areas.

-(8) The requirements for properly labeling and storing radioactivematerials and the procedures for handling contaminatedlaboratory equipment.

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OFFICIAL RECORD C0pY ML 365 PELCHAT - 0002.0.007/20/88

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Your application fat 1s to describe the procedures that would be followedPlease5. in the event of an emergency involving radioactive materials.These proceduressubmit a copy of your radiation emergency procedures.should include the name and telephone number of the RSO and what stepsshould be followed by personnel in an emergency.

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Your application fails to describe your program for performing radiationThe radiation-G. and contamination surveys as required in 10 CFR 20.203(b).survey program should include the following:

-Wipe surveys for radioactive contamination and area surveys madewith a portable radiation survey instrument when appropriate.

a.

A description of the areas where radiation surveys will beThis should include all areas where radioactive materialb.performed.including waste are used and stored.

The frequency at which radiation surveys will be performed.c.

The radioactive contamination levels at which decontamination willd.be performed,

Your are reminded that 10 CFR 20 requiresRadiation survey records.that records of radiation surveys must be maintained in units ore.

subunits of rems (exposure) and curies or disintegrations perminutes (activity).

Please submit a complete copy of your radiation survey procedures.Please reply in

We will continue our review upon receipt of this information.duplicate to my attention at the Region I office and refer to Mail ControlNo. 108352.

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,

Original Signed By1

[oh N Ii*nTeman, ChiefNuclear Materials Safety Section BDivision of Radiation Safety

and Safeguards

Enclosures:Regulatory Guide 10.210 CFR 19

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#" * * 16 FEB 1988'

:International Biotechnol"ogies, Inc.

'

! -ATTN: Darlene W. B.iancaP. O. Box 9558New Haven, CT 06535

Docket No. 030-20106

License No. 06-21254-01,.

Control No. 108352e

. SUBJECT: LICENSE RENEWAL APPLICATION.

Gentlemen: I

This is to acknowledge receipt of your application for renewal of the '

material (s)licenseidentifiedabove. Your application is deemed timelyfiled, and accordingly, the license will not expire until final action i

has been taken by this office.

'- Any correspondence regarding the renewal application should reference thecontrol number specified and your license number. j

1

Sincerely,

IfrTgTanT Wigned Dryboris J. Foster .

John E..Glenn, Ph.D., Chief , ;

Nuclear Materials Safety Section B i-

Division of Radiation Safety andSafeguards-

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International Biotechnologies, Inc.*

".26 Science Park -

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New Haven. CT 06611~ Telephone:(208)786 6600 ~

Toll Free:(800) 948 8666,

Telex: 648998 - - t'

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iU. S..Nucicar Regulatory Commission ,

: Region I ;.

1631 Park Avenue. King of Prussia, PA 19406

,

:/ ' Re: Renewal of License Number 06-21254-01 -Qcog_

l'fnDear Sir: January 22, 198B9.

'

4:1:19Enclosed please find an application for renewal of N.R.Cy, Lic,ense

number 06-21254-01, and all supporting documents. I have also included?the most recent license amendment and a resume of all people in charge ' %v '

of supervising. radioactive work, as well as a diagram of areas in whichuse' and/or storage of radioactivity will be conducted'. If any more informationis.necessary or.if you have any questions regarding this application forrenewal, please do not hesitate to contact me, or Dr. Douglas L. Vizard at(203)-786-5677(or 5663) . Thank you for your attention.

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KDarlene W. BiancaRadiation Safety Officer,International Biotechnologies, Inc.3rd Floor, 25 Science Park275 Winchester Avenue.New Haven, CT 06511

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MATERIALS. LICENSE Amendment No'. 01. |,

. [T | Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, I

Code of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations |V .

heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, gg

source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to I.fI deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This | |

:li:ense shall be deemed to contain ti e conditions specified in Section 183 of the Atomic Energy Act of 1954, as arnended, and is I L*

'l

- subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any |'

conditions specified below,it g<

Ocensee I- In accordance with application dated- 1

,

January 23 1987 I |-

._

li -International Biotechnologies Inc. 3. ucense numbe,r 06-21254-01 is amended in Iits entirety.to read as follows: ;. , , l i '

2. P. 0. Box 9558<

h_ 4. Ex. 4 spiration'dateFebruary 29, 1988 l |h.b r. e |,

New Haven, Connecticut 06535 i ',

e s 11U 5. Docket or 'N *A Reference No. ' D30-20106g |

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6. Byproduct, source, and/or ( 7. Chemical and/or physical Maximum amount that licensee Ispecial nuclear material form

[jnder this licensemay possess at any one time Ies ,x

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.C.-Sulfur 35 Q[ C.yAnyy T-n. 9)|[;A Ahy A. 10' millicuries IIA. Hydrogen 3 bC. 10(dillicuries [ 'B. Carbon 14 4B. B. 10

?Any| iM millicuries gI' 4

p_ D.iAny}. g i n g p , 10D. Phosphorus 32 D illicuries

9. . Authorized use v/ g ta p -

For use ifboductinglin.v'itro laboratory , studies. Co (I|A. through D. %

,a ~t'; J ~~- - AR?O'9

(CONDITIONSa j" 4' (q p. N,

,

N]! \ N!.Licensed material shall be'used only at;25' Science Park,(X .n

.10. 3rd floor, and 275 N'

Winchester Avenue, New Ha'vep Connecticut. $ {u i

i 11'. . ' Licensed material shall be used by,'or un' er lhe~ supervision of, Darlene Bianca or]d

'

| Douglas Vizard. ' ''

..

i. 12. Licensed material shall not be used in or on human beings.1

,

L- 13. Except as specifically provided otherwise in this license, the licensee shall

conduct its program in accordance with the staten'ents, representations, and ;

procedures contained in the documents including any enclosures, listed below. g

-The Nuclear Regulatory Commission's regulations shall govern unless the state- Iments, representations and procedures in the licensee's application and corre- Ispondence are more restrictive than the regulations, l

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0 MATERIALS IlCENSE 06-21254-01'

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Amendment No. 01'

.

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((13, continued)~ CONDITIONSH ,

h A. : -Application dated December 23, 1982 ;

E B. Letter dated January 25.-1983 !

C. Application dated January 23,1987 : iJ. .D. Application dated March 23, 1987t E. Application dated April-9,.1987.

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For the Nuclear Regulatory Commission

\M| .:Date . APR 171987 B

Nuclear Matertels Safety and ii

Safeguards Branch, Region 1>:

; King of Prussia, Pennsylvania 19406, 1

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