Document jg96XNVZvQjZnrB03Z5OoB1pk

BFGoodrich The BFGoocInch Company 3925 Embassy Parkway Akron. Ohio 44313-1799 /jA/ */ys -f j August 8, 1990 Mr. Kevin Swatofh Achilles, U.S.A. P.O. Box 2287 Everett, Washington 98203 RE: FDA STATUS OF POLYVINYL CHLORIDE (PVC) RESIN Dear Mr. Swatofh: This is in response to our conversation regarding the prior sanctioned status of PVC. Polyvinyl chloride is prior sanctioned for use in general food contact applications, both flexible and rigid. The prior sanction is based on an article by A. J. Lehman, from the FDA, published in the Journal of the Association of Food and Drug Officials. July, 1951. The current Good Manufacturing Practice (GMP) specifications for prior sanctioned PVC are a maximum volatility of 3.0% (1 hour at 105C) and an inherent viscosity of not less than 0.35 by ASTM D-1243-79. PVC is also listed as an acceptable ingredient of food contact articles under 21CFR: 175.105 175.300 176.180 177.1010 177.1200 177.2250 179.45 As promised, I am enclosing a copy of the 1986 FDA PVC proposal which acknowledges the prior sanctioned status of PVC. To date, the FDA has not finalized the proposed regulation mostly due to preparation of an environmental impact analysis. Consequently, PVC retains its prior sanction status as explained above. 20868001 BFG07566 Mr. Kevin Swatofh August 8, 1990 Page 2 If you have any further questions, regarding the FDA status of PVC, please call me at 216/374-3422. Sincerely THE BFGOODRICH COMPANY W. C. Bachtel Toxicologist Environmental Health and Safety Management Systems 0808-1/jp G. Schaaf - CL-OTM (w/o attachment) BFG07567 208GS002