Document 71p0JK74rZ3kdXRnwGM872DbE

C. M. NCHCR SKNIOft VlC PHKaiBKMT Ethyl Corporation September 8, 1977 Hearing Clerk Food and Drug Administration Department of Health, Education and Welfare Room 4-65 5600 Fishers Lane Rockville, Maryland 20852 Docket No. 75N-019O - Notice of Proposed Rulemaking re Vinyl Chloride Polymers in Contact with Food, 40 Fed. Reg. 40529 (9/3/75) Dear Miss Peterson: Attached is a position paper which ties together the submissions of June 6, 1977, June 27, 1977, July 18, 1977 with the most recently developed data from experiments proposed to FDA on January 19# 1977. The conclusions that have been demonstrated are: 1. There is a "Non-Migration" level of Vinyl Chloric Monomer (VCM) from Polyvinyl Chloride (FVC) bottle to contents. 2. The process can be controlled. 3. Therefore, there is NO reasonable expectation of VCM migrating from bottle to contents. 4. The Ethyl Corporation respectfully requests con currence of these conclusions. Sincerely, 2628005 Clarence M. Neher, Ph. D. Senior V. P. and Director mar attachment Ethyl Tower / 45) Florioa / Baton Rouoe, Louisiana 70801 1