Document zz8z685jZpwkGDMw65rkDkYga

I MONSANTO COMPANY cc: E. P. Benzing St. Louis, Missouri V V A. J. A. Eryan R. J-. Christman Jack .Early - Washington P. R. Graham S. A. Heininger DEV. DEPT. CALL REPORT NO. 40-67 H. T. Holland Wm. Hunt Robt. Keller . G. G. Kosup Pood & Drug Administration- K. A. Pollart Washington, D.C. A. H. Tifft DATE 0? CALL: May 11, 1967 df: PC - FDA PC - Binders - Coatings FOR FDA Herbert Blumenthal Willard Orr K. P. Misra Joseph McLaughlin A1 Holtz FOR MONSANTO Wm. KUnt Robt. Keller M. V. Merchant PURPOSE OF CALL: To review extraction data on pigment binder PB-702. This meeting proceeded smoothly. A cursory review of our data brought forth a favorable response that we should proceed to submit a petition for approval. Additional information was requested pertaining to characterization of the polymer film and analysis of the emulsion for free acrylamid. DETAILS: The meeting opened with a review of coating applications to paper and paperboard and the methods employed by Monsanto to prepare papers for extraction. The makeup of ouj* polymer system was also discussed. A series of questions which werte asked by the FDA personnel included: "Have you supplied validation for your analytical procedures?" "What coat weights have you applied and why this level?" "Have you tested the emulsion for free acrylamid?" "Will you provide polymer characterization data?" "What solvent may be used to dissolve or swell your polymer?" In summation, it was suggested that Monsanto proceed to file a' petition to modify the sections of the Federal Register pertaining to use of chemicals in the manufacture of paper and paperboard which will come into contact with dry, aqueous and fatty foods. Information to be RSV 0008905 PDA - Dev.*Dept. Call Report No. 40-67 Page 2 added to the report should Include polymer characterization data, such as molecular weight and solvent swelling data, also viscosity of the emulsion and finally the analysis for free acrylamid in the emulsion. On the subject of analysis of free acrylanids in the emulsion, it was pointed out that techniques for analysis had been published by Hercules and Dow in their previous petition to PDA for wet end addition of poly acrylamid polymers. They agreed to provide us with information on this analysis but stated that our results might, be different based on the effects of different extraneous`materials. M. V. Merchant /ds RSV 0008906