Document Z8v02pO3dYZOaNKn2v882nMGO

#0-1184 inter-office memo TENNECO OIL P&M 'L/C" T R. S. Miller From p_ Ketterer Subject SPI Packaging Committee Flemington At Flemington Date Feb. 29, 1984 Copy TO G. E. Dlsch D. Goodman D. H. Hunter R. R. Merkel R. W. Stevens On Feb. 21 and 22 I participated in initial meetings of two task groups organized by the Technical Information subcommittee of the Food, Drug and Cosmetics Packaging Materials Committee of SPI. Both meetings were held at the offices of Keller & Heckman, Washington, D.C. These task groups are the ADL Report Task Group, of which I am chairman; and the VCM Analysis Task Group, of which I am a member. The ADL Report Task Group was established to study the final report of a 6 year, $5,000,000 study of food simulant extraction tests performed by A. D. Little for the F.D.A. The study was commissioned to determine whether the FDA guidelines for migration data of packaging materials is an accurate approximation of actual migration to food, etc., under real-world conditions. A number of polymer/ additive systems were studied, including plasticizer from flexible PVC film and tin stabilizer from rigid PVC. The study found that present FDA guidelines exaggerate migration in 80-85% of the cases, and made a series of short-range and long-range recommendations to reduce the number of underestimates. Some of these recommendations are logical and supported by the study, while others are highly objectionable or require further definition. In this latter category are suggestions that FDA require disclosure of polymerization recipes and compound formulations in future petitions, and that FDA adopt a questionable theoretical treatment of migration data to estimate long term migration from short term data. Other objectionable aspects of the work include the extraction test cell, which exposes both surfaces and cut edges of the sample; and the choice of which food simulating solvents should be used for various foods. The VCM Analysis Task Group was established to develop a method for the determination of VCM in food and/or food simulating solvents, which will have sensitivity to 1 ppb VCM, but will not be readily modified to detect smaller amounts. The Food, Drug, and Cosmetic Packaging Materials Committee has decided that extraction/migration data is preferred over determination of VCM in the packaging material itself as a means to get favorable regulatory treatment at FDA. It is anticipated that whereas analysis of the package will show the presence of low levels of VCM (low ppb), no VCM will be detected in migration tests at 1 ppb. Part of the push in this direction seems to have come TEN 4994 r2- - from meat-wrap producers, notably Dow (re: Saran), who claim they cannot produce film at the same low levels of VCM achieved In rigid film and bottles. These people do not want a regulation on VCM in rigid PVC that may be extended to include their products. Both task groups have begun work which will continue at least until this summer. The ADL Report group has requested further information from FDA through Keller & Heckman, and is continuing to study specific portions of the ADL report. The goal of this group is to have at least a preliminary report with recommendations for the next meeting of the full Food, Drug and Cosmetic Packaging Materials Committee in June. The VCM Analysis group has outlined a potential method (a modified version of the Diachenko FDA procedure), for trials on standards in all labs. A full-scale round robin will follow if this is successful. I may be asked to supply PVC bottle compound at low and high VCM content for the round robin. The goal of this group is to provide a satisfactory method to FDA before they have taken any regulatory action on PVC. A mention was made by Dr. Louise Rainey of Dow of a short item in Food Chemical News in Jan. or Feb. of this year concerning a European feeding study done on PVC resin. Rats fed PVC resin were claimed to have developed tumors. No details were given, and Dow has not yet received an answer to their inquiry to the author. We do not get this publication, but I have asked if Dow will share their information with us. These two task groups have scheduled their next meetings for April 3 and 4 at Keller & Heckman. I believe this to be an important activity for Tenneco Polymers, and am planning to continue my participation. PAK:sm P. A. Ketterer TEN 4995