Document EdaLnGJd115L0ok1ov4k7DdLR

4 joiim r kkucr JEROME H. MECHNAN WIC.UAM M. AONOHEftAN'. JN MALCOLM D. M*AIITKUA WAYME V. CLACK TERRENCE D. JONCl MARTIN W. ICACOVlCl JOHN s. CLDRCG CAROLE C. HARRIS MANY MAHTMA MCNAMARA MICHAEL F. MONNONE MANK FOX EVENS JOHN ft, RICHARDS JOHN m. DUNECK NCTEN L. OB vi CRUZ cnmiTmc u. sill MELVIN . ONOECN *HrALEV a. rwiMQTO LAWHENCE R. HALNHIN ALNH A. flMMON# ncten a. sumer C COUCLAa JANNEtT NOT ADMITTED IN O.C. MCILAA. MILLAR NATNICK J. HURD ftBOME A. MlftRO FREDERICK J. OAY, JR. MANCU K. COVAN a. craio TAurrut MANK A. a(EVENS MICHAEL N. NENNET O. rNANKLIN KOONTZ CATHERINE N. NOEMEN NICKANO A. JAFFE+ JEFFREY . KCNN KNia ANNE MONTElTM ELLIOT NEULOa AKANNON L. OCNMAN SUSAN E. TON* MANK L. ITZROPP EDWIN C. MOURE* MANC OCNCJKA JUSTIN F. MCCARTHY KENNETH A. OLSEN Jeffrey a. land* LAW OFFICES Keller and Heckman 1150 I7*m STREET, N.W. SUITE tOOO WASHINGTON, D.C. 20036 (202) 956*5600 February 8, 1990 SCIENTIFIC STAFF DANIELS. DIALER. Rh. D. CHARLES V. SNCOER, An. O NOSCRT A. MATHEWS, Nm. D. JOHN N. MODOCRMAN, Nh. O MOLLY HMTMIRC FOLEY JUSTIN C. NOWELL. Mm. D. TELECOMM U N (CAT I On S ENGINEER CHARLES F. TURNER TELEX TCUCCOMIER Itoi) CASLC ADDRESS "HELMAN" WRITER'S DIRECT DIAL MUNDER (202) 956-5641 VIA FACSIMILE Hr. Joseph C. Ledvina Vista Chemical Company 900 Threadneedle Street Houston, Texas 77079 Re: FDA Status of PVC Resins Manufactured with BUS 80 Dear Joe: In your facsimile letter of February 2, 1990, you requested our opinion on the Food and Drug Administration (FDA) status of polyvinyl chloride (PVC) resins manufactured with the use of a production aid, known as Build Up Suppressant (BUS) 80. BUS 80 is not intended to be present in the finished food contact article, but the PVC resins may contain trace amounts of BUS 80 as a result of the manufacturing process. Vista has, therefore, performed extraction studies to determine what, if any, residual levels of BUS 80 may be present in its finished PVC resins. These extraction studies indicate that BUS 80 is not present in resin samples at a level of 50 parts per billion. Based on this information, if appropriate extraction studies were conducted on food contact articles prepared from this resin, and assuming 100% of migration of the BUS 80, it would not be detected in food simulating solvents at an analytical method sensitive to 50 ppb. Hence, BUS 80 is not reasonably expected to become a component of food, and is therefore, not a food additive. Thus, it is our opinion that Vista's PVC resins, otherwise complying with the Food Additive Regulations, may properly be used in contact with foods without regard to the use of BUS 80 as a production aid in the manner described, and that such use of the resins may be said to comply with the UEV-145117 Mr. Joseph C. Ledvina February 8, 1990 Page 2 A Keller and Heckman Federal Food, Drug and Cosmetic Act and the Food Additive Regulations. We will provide you with a more detailed longer letter within the next few days explaining the basis for our opinion. We trust that, for the present, this letter is responsive to your request for our opinion on the FDA status of Vista's PVC resins. Should you have any questions, however, or if we can assist you in any other way, please do not hesitate to let us know. Cordially yours. Peter L. de la Cruz A L KfULCK JOMCii u;uu> M. M^bCOt.* D. NMAirav* *** v. w^e . JU MA^TiM w. v-- i. <ba*c C**Ok 4 mamiB BAHT NAPCTHA M4HAHAVA MCKACfc. *. H9*OMC NAM rox CVCNft *. CNA*D JAM . OVtC FfTM I.WU Cft<Z m, +<wh MtcVIA t. IW0CCN a. rujIMQTO kAWAtNeC A. M*L/rN 4*1** A. BIMNOMS tree a. susscii c. OOUOl_A* JAIMMTT NOT AMlTTtO IN OC #i'WA a MILlAA AaT *<w. V nu4o CCC# -4.0 OA*' maACa a. C9mm .<**! ^WTfttT NAN* A 8ICVCA3 -iCNAtu *. BCNArr a r**KLIW KMNTZ CatnCAinC N ROt-:f tfiCMAAOA JAf*C* v|Ff(r # *f* --.A 4NH< .*e TH C4.L-GT *rf<.n^S VhahkOm l. SUSAN C. rOK* M L. ITBACrr C,Wl* C. NOVAS* MAIC CAC-'AA JUSTl * Mc^t-Xr *CW*C* *. C_V*U gC"M . can** : ' lAWOr/KE3 Kellf.r .wr Hkckman u?t) I.'* *'1 Ri.KT. S ,'k I ? JC'OO WASHINOIOK, D C. 20036 / (2(ie) 650-5900 February 8, 1990 HOtNrttlC 9*m.Cl. 1 &!V. f* o. (iiMtas v, sttcoga. *. _ SCT*. MATnCoS O. .'i*K 0 OCBDCNU, - e. OwCy wvtmmi* roi.e'c juBTih C, ac*Ei.l. a- o. TCkCCOMMuu CATifinS LN^iNcea BMA>Wr TL**iC9 TC4AJI ,9,9. yLCCO>-CM tt9> MA Ttfl CA9LC AoeaCSA -kCkMAN* WAie * i*ect 0<JM. (202) 956-5641 VIA FACSIMILE Mr. Joseph C. Ledvina Vista Chemical Company 900 Threadneedle street Houston, Texas 77079 Re: FDA Status of PVC Resins Manufactured with BUS 80 ,Dear Joe: In your facsimile letter of February 2 1990, you requested our opinion,on the Food and Drug Administration (FDA) status of polyvinyl chloride (PVC) resins manufactured with the use of a production aid, known as Build Up Suppressant (BUS) 80. BUS 80 is not intended to be present in the finished food contact article, but the PVC resins may contain trace amounts of BUS 80 as a result of the manufacturing process. Vista has, therefore, performed extraction studies to determine what, if any, residual levels of BUS 30 be present in its finished PVC resins. These extraction stiSltes indicate that BUS 80 is not present in resin samples at a'level of 50 parts per billion. Based on this information, if appropriate extraction studies were conducted on food contact articles prepared from this resin, and assuming ioo% of migration of the BUS 80, it would not be detected in food simulating solvents at an analytical method sensitive to 50 ppb. Hence, BUS 80 is not reasonably expected to become a component of food, and is therefore, not a food additive. Thus, it is our opinion that,, vista1 s PVC resins, otherwise complying with the Food Additive Regulations, may properly be used in contact with foods without regard to the use of BUB 80 as a production aid in the manner described, and that such use of the resins may be said to comply with the Mr* Joseph C. Ledvina' February 8, 1990 Page 2 A Keller and Heckman Federal Food/ Drug and Cosmetic Act and the Food Additive Regulations* We will provide you with a more detailed longer letter within the next few days explaining the basis for our opinion* We trust that, for the present, this letter is responsive to your request for our opinion on the FDA status of Vista's PVC resins. Should you have any questions/ however, or if ve can assist you in any other way, please do not hesitate to let us know* Cordially yours. Peter L* de la Cruz VEV-145131