Document NGBL6meqZkpK1M2v0N3NjQXgD

HISTORY Page 6 of 6 1973 Nov., 1974 Jan., 1975 Sept- > 1975 Sept., 1975 1976 / Jan.. 1977 Jan.. 1977 May. 1977 June, 1977 Ethyl confirms up to 500 ppm in bottle compounds. Ethyl advises FDA< 1 ppm VCM specification by January, 1975, for food-grade bottle compound. Ethyl provides FDA with prediction model for advance determination of maximum potential VCM migration to bottle contents. Ethyl established < 1 ppm specification for all bottle compound. FDA publishes proposed ruling: PVC Film -- OK PVC Plastisols -- OK Blister and Bottles -- Questionable Subsequent studies confirm Ethyl prediction model for maximum potential migration. Actual results 70 to 85% of prediction under accelerated conditions. Ethyl production of all bottle compound averaged <0.2 ppm VCM for entire year -- ambient storage conditions yield as low as 25% maximum predicted. Analytical ability (head space gas chromatography) improved to the point that interferences in the low parts per billion range show up. FDA commented on the need of confirmation of VCM by mass spectroscopy. Ethyl proposes to FDA experimental protocol to establish a Non-Migration Level of VCM as confirmed bv GC/MS. Experimental program completed and non-migration level established. Results based on both FID and GC/MS analysis. GC/MS conducted by independent laboratory. Ethyl proposes continued use of PVC bottles for food packaging at a non-migration level of VCM which ensures there is no reasonable expectation that VCM may become a component of bottle contents under normal conditions of use. VC1098