Document 0Jx516ZD964v7x7NRB3b4LmM

I /hO'/Ao(> November 13, 1963 Mr. L. T. C*siillerl Technical Manager BOOKER CHEMICAL CORPORATION Ruco Division Nov South Road Hiclerville, New York 11802 Deer Lou: A member of your staff, Mr. Fabrizio, telephoned last veek regerdlr^ the FDA ettltude. on vinyl resins and more specifically, I believe, how the FDA policies might effect the use of bulk resins in specific applications. Our original FDA approvals were based on studies done many Fears ago on Geon resin. It Is our attitude that IDA la not concerned about the manu facturing process used to make our different resins. We aetlsfy ourselves that a resin will present no hazard in a specific application by running the prescribed extraction testa. It 1 our present opinion that the manufacture of polyvinyl chloride by the bulk polymerization process will not require nev toxologlcel or feed ing studies. We do not now deem it necessary to initiate any discussions with FDA on resin mode by this process which. In our opinion, falls vlthln the category of prior sanction resins. We hare been Informed that Dow ran extraction studies on the following PSG resins: KB 8010 OB 9010 GB 1010 <3 11ID GB 1210 BFG04357 Tooessoz BOOKER CHBCXCAL CCRP. Mr. L. T. Cemllleri Page Two 11/13/68 Dow data Indicated the above polymers can be used in food packaging applications and will ccaply with PDA requirements under the Pood Additives Amendment. If Mr* Pabrlzlo wants to be Informed on the PDA regulations, we suggest be get frca the Pood and Drug Administration their food additive regu lations that pertain to indirect additives. Mr. Febrlzlo also inquired about the molecular weight of Qeon resin 1C& which le Just a ahpde lover than Qeon resin 103* tbs inherent viscosity, according to ABTM 12^3-60, of our resins la as follows 1 Geon Resin 101 - 1.10 Geon Resin 103 - O.96 Qeon Resin 104 - 0.66 If you have any further questions, please let us know. Cordielly, Jamas S. Wolff/j bee McCormick - Akron L.R. Jimenez E.B. Osborne B.M.G. Zwicker Sales Manager Monomers and Petrochemicals c1C OS m Gs o p BFG04358