Document xjE276R0p2zKJo60MBBRYDoBb

U 1#*2 INTERNAL CORRESPONDENCE received _______ -P? 11919_______________ CHEMICALS AND PLASTICS RIVER ROAD, BOUND BROOK. NEW JERSEY 08805 TO <N,fT) jnjr> R. M. Arnold - TC Dr. L. E. Brydia - BB/200 Mr. T. B. Gibb - BB/200 Dr. R. A. Gregory - BB/203 Mr. R. E. Gulick - NY/33 Dr. G. T. Kwiatkowski - BB/200 Mr. R. H. Dasher - NY/33 Mr. G. S. Peacock - BB/95 Mr. N. H. Reinking - BB/98 Dr. R. R. Szoc - BB/203 Mr. W. I. Wertz - BB/98 Dr. F. G. Willeboordse - BB/98 Mr. R. N. Wheeler -, Dr. M. J. Yousseffi - BB/200 March 15, Originating Dapt. Answering lattar d*t# Subi*ct 1979 Attached herewith is a first draft of a protocol for our solvent vinyl resin residual monomer studies which was prepared by Glenn Peacock and I from Tom Gibb's action plan. Please make any chanqes directly on your copy and return to me as soon as possible, we would like to submit this to FDA before April 1. I can anticipate potential problems with the solvent evaporation studies. Also, 1 am bothered about the September 1 completion date, but I doubt if FDA will accept a longer delay. WBA:sdb 13C-A-20 W. B. Ackart Manager, FDA Liaison ucc 029819 -2- The Bearing Clerk (5 copies) Pood and Drug Administration Room 4-65 5600 Pishers Lane Rockville, MD 20852 March 15, 1979 Docket 75-N-0190 Dear Sir: He submit herewith a protocol of an experimental program currently in progress at Onion Carbide Corporation laboratories. This is designed to demonstrate that continued use of Union Carbide's solution polymerized vinyl copolymers and terpolymers in resinous and polymeric coatings for use as food contact surfaces, as currently regulated under Title 21 CFR 175.300, will not result in vinyl chloride monomer becoming a component of food. Very truly yours, WBA:sdb Attachments cc: Dr. Arthur Lipman (3 copies) Bureau of Foods HFF 334 Food and Drug Administration 200 C Street, SH Washington, DC 20204 H. B. Ackart, Ph.D. Manager, FDA Liaison ucc 029820 -3- PROTOCOL TO DEMONSTRATE THE ABSENCE OP VINYL CHLORIDE MONOMER FROM POLYMERIC COATINGS COMPOSED OP BAKELITE BRAND SOLUTION POLYMERIZED VINYL RESINS Objective; This experimental program is intended to demonstrate that the continued use of "Bakelite" brand solution polymerized vinyl copolymers and terpolymers as components of polymeric coatings used in contact with foods will not result in vinyl chloride monomer becoming a component of food at any level. These copolymers and terpolymers are cited by chemical identity in 21 CPR 175.300 and by reference in 176.170 and 177.1210. The experimental program, which has been in progress for approximately one year, consists of three parts as follows; Part A; Analytical Methods Development. Part B: Resin Measurements. Part C: Solvent evaporation Studies and Mathematical Modeling. Details of our findings to date and our proposed program are discussed in the following sections. A. Analytical Methods Development Studies in UCC laboratories, previously discussed with Bureau of Poods personnel, showed that the analytical method developed in their laboratories for the determination of vinyl chloride monomer is not completely satisfactory for uBe with vinyl copolymers and ter polymers. However, a modification of this method, which utilizes an electrolytic conductivity detector, has eliminated problems of massive interferences in the analyses of our products. We propose to carry out the following additional studies to validate the accuracy and sensitivity of this modified procedure. UCC 029821 -4- 1. Resolution of FDA/OCC differences in residual vinyl chloride monomer in Bakelite brand vinyl chloride-vinyl acetate copolymer VYHH. To be done by analyzing spiked samples of resin by both methods. 2. Determination of precision of current UCC modification. To be done by obtaining six values for single samples of VYHH and VYDS resins over a two-month period and applying suitable statistical methods. 3. Development of improved methodology applicable to all vinyl resins through participation on ASTM committee D-20.70.03. B. Solvent Evaporation Studies and Mathematical Modeling . 1. Solvent Evaporation Studies Resin samples will be dissolved in solvents typically used in the manufacture of solution coatings. Residual vinyl chloride monomer will be analyzed immediately, at various stages of evaporation, and, if possible, in the cured coating. A family of curves will be developed by adding monomer at various levels to the original solutions. Certain assumptions must be made and validated in order to simulate the coating process. 2. Mathematical Modeling a) The most simple model will be based upon the level of monomer in resin at the customer's plant, and will include the assumption that all of this will migrate to contained food. The maximum level of monomer that could be present in food under this assumption would be less than 0.002S ppb. b) Theoretical considerations indicate that most, if not all, of the monomer present in coatings solutions will not remain in the finished food contact coatings. We will develop mathematical models from the data obtained from solvent evaporation studies to show that vinyl chloride monomer cannot be present in foods. Coup letion date: Target date for compl tion of this program and the submission of a final report is September 1, 1979. yCC