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Matls Licensing Package for Amend 4 to License 20-20783-02 for T Cell

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Matls Licensing Package for Amend 4 to License 20-20783-02 for T Cell .- ~ .- , - . - - , _ . - - - - - . m r' = = = m= =q m =_ % =>i=_= = = = = = = = = = = = * a; 4 NRC TOMV m = =ma=a1 = = = = 3= = = = = = y>' * ~ NS q pomL U.S. NUCLE AR REGULATORY COMMISSION g[ MATERI ALS LICENSE Amendment No. 04 (- h og y/ Purniant to the Atomie I nergy Act of 1954. as amended, the linergy Reorganitation Act of 1974 (Publie in 93-43Rh and Tule W. |Q ~ I Cale of I ederal Regulanons. Chapter i, Parts 30, 31, 3133, 34, 35. 39,40 and 70, und m reh.ux e on wtements mal reprocniatsns heretohire [>l - g nude b> ihe hansee a hecme h hereby nsued amhorinng the beensee to recene, auimre, possca ad Hansfer byptabiet, somte, and spesial h i nuelcar materul designated below, to use such inateri.d for the pur1% cts) atal ai the place (s) designated behm to deiner or trarnfer such tnatenal h _ { to perwm amhonfed to recche it m accordarne w uh the regulations of the apphesble Parthd 1 hn hsense shall be deemed to contain the conditions ! { spennca in scolon tx3 of de Atonue i nergy Ad of 1954. n amended. and h suNca to aH appheable ruiew regulanons arat onlers of the Nuclear p j Reputatory romnumou now or hereaf ter in etteet and to any ointhtiinn specined below _ ip : : 'y l__--___._._-_ ij in accordance with letters dated h i November 24, 1992, ih i j 1. -T Cell Sciences Incorporated 3. bcense number 20-20783-02-is amended !% - ; in its entirety to read as follows: 4 1 38 Sidney Street - - - - - - @ Cambridge, Massachusetts 02139 4 spiration date March 31, 1997 h , , b ! , 5 Docket or |j I 030-29658 > 1; i Reference No ._ | 1 6 th product, source, and/or 7 Chemkal and/or physical S. hiaitimum amount that licensee . special nuclear inatenal form may possess at any one time h_ i under this twense i !A. Cesium 137 A. Sealed source (ORNL- A. 600 Curies j! q RAMCO-50 or 150-1000) |1 !| ,|9. Authorized use % 4 k : A. For use in an AECL Gammacell 1000 Model A Irradiator for the irradiation of material N % except explosives and flammable materials. 4 4, in f CONDITIONS. h >1 10. Licensed material may be used only at the licensee's facilities at 38 Sidney Street,-. q Cambridge, Massachusetts. y h I11. A. Licensed Material shall be used by, or under the supervision of, '- Carolyn Pettey, Ph.D., Roseann Glaser, Ph.D., Larry Henry or Karin Evans. g[ , t - - M 4: B. The Radiation Safety Officer for this license is Ellen M. Essigmann, Ph.D. 11 4 hj - L , :12. Sealed sources or detector cells containing licensed material _ shall not- be opened or- h | i sources removed from source holders or detector cells by the licensee, f1 u : 4 | [13.'A. Sealed sources and detector cells shall be tested for leakage and/or 9 o : contamination at intervals not to exceed 6 months or at such other intervals as L | are specified by the certificate of registration referred to in 10 CFR 32.210, %;N j not to exceed 3 years. !h - h B. -Notwithstanding Paragraph A of this Condition, sealed sources designed to emit- alpha particles shall be tested for leakage and/or contamination'at intervals not to exceed 3 months. p )W]t| 0 0 120134 -OFFICIAL RECORD COPY b BM80M 89it _______,j____jML 10 I y - _ _ _ - ____-_ ___-________ _ _ - __ - -- - _ - -_.__-_ - _ -_-_---______-___---- dS Er A CO M SS O p W84 q 1icenw nutnter ;j 2 q g MNIliRI ALS LICENSE g g gn;n,n,,0at E M _ - 4 SUPPLEMI NT ARY SHEET ij !q _ _ _ _ .030-29658 - .-- ?{ 4 H - - - ____ _ - _ - 1- - /sendment.No._01 _ __ (13. Continued) CONDIT 1014S N h:. a fl C. In the absence of a certificate from a transferor indicating that a test has jii V been made within six months prior to the transfer, a sealed source or detector :M / cell received from another person shall not be put into use until tested, l. l f. i !! D. Each sealed source fabricated by the licensee shall be inspected and tested for ! h construction defects, leakage, and contamination prior to any use or transfer asl i a sealed source. !i i's E. Sealed sources and detector cells need not be leak tested if: !!' # !A|p h (i) they contain only hydrogen 3; or {- (ii) they contain only a gas; or j # (iii) the half-life of the isotope is 30 days or less; or ! h ! f (iv) they contain not more than 100 microcuries of beta and/or gamma emitting ! f material or not more than 10 microcuries of alpha emitting material; or h Il ( (v) they are not designed to emit alpha particles, are in storage, and are not jf being used. However, when they are removed from storage for use or | @{ transfer to another person, and=have not been tested within the required | 4 leak test interval, they shallibe tested before use-or transfer. No sealed $ source or detector. cell shall;be istored for a period of more than 10 years without being tested for' leak'agefand/or_ contamination. b ( F 4 , $ F. The test shall be capable of detecting the presence of 0.005 microcurie of k _ radioactive material on the test sample. Records of leak test results shall be p kept in units of microcuries and shall be maintained for inspection by the !p j}f, Commission. If the test reveals the presence of 0.005 microcurie or more of |ti removable contamination, a report shall: be filed with the U.S. Nuclear !N 4|i4 Regulatory Commission and the source shall be removed from service and h l$ decontaminated, repaired, or disposed of in accordance with Commission k regul ation s . The report shall be filed within 5 days of the date the leak test i,1 g result is known with the U.S. Nuclear Regulatory Commission, Region I, ATIN: M k Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of Prussia, ti Pennsylvania 19406. The report shall specify the source involved, the test %{[ results, and corrective action taken. j|1"j !q 'M y G. The licensee is authorized to collect leak test samples for analysis by Bolton |y k and Galenek, Inc. Alternatively, tests for leakage and/or contamination may be pi % performed by persons specifically licensed by the Commission or an Agreement f! 9 State to perform such services. h 4 h 14. The licensee shall not perform repairs or alterations of the irradiator involving removal of shielding or access to the licensed material. Removal, replacement, and hp (g disposal of sealed sources in the irradiator shall be performed by a person li k specifically licensed by the Commission or an Agreement State to perform such N services. g V v bttw wmEvittttic wmyx%tte wachte mtymith h xr e r.zhttism N -_ _-- _-- - - - - - - - _ - - - f *1r m sm ?x x x= E L 7 2=5'2?s?1*1 1 U:S NU AR~1?riiim?53*2CFMa*&*WL*Msm?W}) REGUL ATORY COMMISSION :3*%ITL'KW3?2*L*375?3?FR3*y NitC F o.rp J14 A * (_ J AGr 3 OF_ _3 D "8 PAGR.f (| Luenw number ;P, M A'I Elll ALS LICENSE * 4 SUPPLEMENTARY SHEET - - - -20:20783:02 _ _ _ f;.h 4 030-29658__ _...._ k i ;Y - _ Ampndment No.. OL F $________ _._..__ _ _ _ _ _ _ _ |h i (Continued) CONDITIONS t 'g 15. The licensee may transport licensed material in accordance with the provisions of 10 ! I 4 CFR Part 71, " Packaging and Transportation of Radioactive Material". ! Ji i 4! 16. Except as specifically provided otherwise in this license, the licensee shall conducti 4j its program in accordance with the statements, representations, and procedures J p; contained in the documents including any enclosures, listed below. The Nuclear !, j Regulatory Commission's regulation shall govern unless the statements, !' i representations and procedures in the licensee's application and correspondence are |, ft| more restrictive than the regulations. f 1 i! A. Application dated December 8, 1986 |i B. Letter dated February 5, 1987 h f! j} C. Letter dated October 26, 1988 p Letter dated December 2, 1988 W D. ;>'| |4I E. Letter dated February 28, 1989 i> % F. Letter dated February 25, 1992 h $ G. Letter dated March 27, 1992 H. Letter dated November 24, 1992 y!I lip! }@( k !>l|b !Ii 4{i M / ;tbi A ~ ,,< : N : I t i 9 i k|4: 'b 4 F! k !bi b kl # i a}> (4 9 h !>l N Ib'i Lt hj F !Fj For the U.S. Nuclear Regulatory Commission : _ 0+ inn! Sirmed Em M Date DEC Z D 1992 By aEr a. x:nemmt_ j Nuclear Materials SiTety Branch , 'hi t Region I |Pj King of Prussia, Pennsylvania 19406 11 fP h bTs' Tav.T&r_TassdmTjsssTmTJs5/rsersrars#smT.samfrirhamsmTm"tr.TakaN$ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ ___ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ - - - _ _ _ _ * ^ - ; : . O O DEC 291992 License No. 20-20783-02 Docket No.
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