Document z9J1XngK943Y1X34dr3q0Qx0

minutes AD HOC VCM/FDA COMMITTEE Rigid Sheet and Blister Pack. Sub-Committee SPI Conference Room New York, New York Attendees 10:00 A.M. September 22, 1975 R. Abramowitz, Hooker Chemicals & Plastics, River Road, Burlington, N.J., 08016 C. E. Blades, Air Products & Chemicals Co., 1 Possumtown Rd., Piscataway, N.J. 08854 N. Bornstein, Cryovac, P.0. Box 464, Duncan, S. C. 29334 R. R. Bouffard, The Pantasote of N.Y., 26 Jefferson Street, Passaic, N.J. 07055 A. Cacciola, The Pantasote of N.Y., 26 Jefferson Street, Passaic, N.J. 07055 D. Dixler, Keller and Heckman, 1150 17th St., N.W., Suite 1000, Washington,D.C. 20036 J. Fleckenstein, Milprint, Inc., 4200 N. Holton St., Milwaukee, Wisconsin 53201 J. Floros. Great American Chemical, 650 Water Street, Fitchburg, Mass. 01420 A. Fuhrman, Great American Chemical, 650 Water Street, Fitchburg, Mass. 01420 W. Gehrke, Curwood, Inc., Box 46, New London, Wisconsin, 54911 W. Gort, American Hoechst Corp., P.0. Box 340, Del. City, Del. 19707 P. Grimgrod, Oscar Mayer E. Hill, Borden Chemical. Co. A. Hirsch, Standard Packaging, 1 Lisbon Street, Clifton, N.J. 07015 J. Hadley, Keller & Hechman, 1150 17th St., N.W., Suite 1000, Washington,D.C. 20036 R. Kingham, Covington & Burling (Tenneco), 888 16th St., N.W., Washlngton,D.C. 20006 E. Kruger, American Hoechst Corp., P.0. Box 340, Del. City, Del. 19707 J. Lawrence, SPI, 355 Lexington Avenue, New York, N.Y. 10017 G. Mantell, Air Products & Chemicals, P.0. Box 538, Allentown, Pa. 18105 M. Saggese, Tenneco Chemicals, Inc., Nixon Lane, Nixon, N.J. 08818 J. Sibilia, Allied Chemical Corp., Columbia Rd., Morristown, N.J. 07960 D. Sterne, The Pantasote Co. of N.Y., 26 Jefferson St., Passaic, N.J. 07055 H. Tenney, Xcel Corp., 290 Ferry St., Newark, N.J. 07105 F. Vincent, American Can Co., American La., Greenwich, Ct. 06830 R. Zarr, Xcel Corp., 290 Ferry St., Newark, N.J. 07105 I. Bill Gort stated his suggestions on how the meeting be conducted in order to meet the required objective of pooling data on PVC Sheet for food packaging. He emphasized the importance of establishing appropriate test procedures. 2. Each company representative was requested to comment on the activities that should be conducted to develop the appropriate data for inclusion with the industry comments to FDA. In summary the group were in agreement to the following. THE SOCIETY OF THE PLASTICS INDUSTRY, INC. 355 Lexington Avenue New York, N.Y. 10017 (212)573-9400 SPI- 10217 - 2- PVC sheet material is now available with less than 1 ppm residual vinyl chloride. ' Tests should be based on FDA method. There is confidence that we have data that can show non-detectable vinyl chloride using FDA's level of sensitivity (0.35 ppm) for sheet material. i Extraction data on this sheet is likewise expected to show no detectable vinyl chloride using FDA's test method. 3. Dr. Dixler stated that the following would be needed for inclusion with SPI comments to FDA on the proposed regulation: One set of comments on tests conducted. Test procedure validation work. The time and temperature of extraction work will be related to the products to be covered. - 120F tests represent an exageration of realistic market storage conditions. - 72F is adequate temperature for most products. - Certain products should include high initial temperature to simulate hot tilling. : Explaination as to how industry has been able to reduce residual monomer content. Data needed extraction data with food grade solvents: water dilute acetic acid heptane or edible oil tests at 120F for 28-30 days or equilibrium. A. Round robin tests on the residual vinyl chloride in sheet will be coordinated by Dr. Kruger with the following: Allied Chemical Air Products American Hoechst Great American Pantasote Tenneco The test will involve sheet at two levels of thickness and residual monomer. 5. It was agreed that each company would do extraction tests on its own material at two monomer levels. Data should be sent to Bill Gort as it is developed. 6. It was agreed that the group would meet again in 4-6 weeks to review progress. The meeting adjourned at approximately 3:00 P.M. Respectively submitted, R Lawrence Technical Director JRL:ctz SPI- 10218