Document 3eZJ2E6ZkeEeNJbXz6vk0V27x

BFG RESTRICTED March 11, 1985 P. C. Ross ACTIVITIES REPORT - FEBRUARY 1985 HEALTH & ENVIRONMENTAL SERVICES DIVISION Environmental Health/Industrial Hygiene/Toxicology 1. The new OSHA labeling law requires labeling of materials according to their hazard(s). In order to assist the Chemical Group in complying with this regulation, we met with Chemical Group representatives to determine whether Carbopol needs to be labeled to note that it contains benzene and that it represents a carcinogenic hazard. After a review of all the data, we concluded that Carbopol does not pose a carcinogenic hazard and does not require labeling as such. 2. An FDA inspection of the Calvert City plant went smoothly. The inspector commented that the plant was complying very well with good manufacturing practice (GMP). He also questioned the need to be registered as a drug manufacturer. We are trying to determine if we are compelled to register by FDA or if registration in BFG's case need only be voluntary. 3. Polycarbophil is a copolymer of acrylic acid crosslinked with divinyl glycol. The FDA over the counter panel (OTC) classed Polycarbophil as safe and effective for a bulk laxative and antidiarrheal agent. BFG has set up a pilot program at Avon Lake Technical to produce Polycarbophil. W. C. Bachtel inspected the area with the engineer in charge and made recommendations to comply with GMP's for such a product. 4. We received USDA acceptance from both the Chemistry Group and the Equipment Group for Novitane FG 95A conveyor belting. We also received USDA acceptance for Goodrite KXP74 and KXP80 for use in egg wash and boiler water treatment formulations. Goodrites K738X1, K759, K758 and K739 were approved for use in egg wash formulations. 23888001 -2- ACTIVITIES REPORT - FEBRUARY 1985 .HEALTH & ENVIRONMENTAL SERVICES DIVISION - contd Medical Center 5. The Centers for Disease Control reports have shown a marked increase in cases of true influenza this winter in many areas of the world. The strain of virus responsible for this outbreak was contained in this year's influenza vaccine which was offered at no charge to Akron employees. While we do not have scientific confirmation/ it is the consensus of the medical staff that most of those seen with severe influenza had not had the vaccine, and that most of those who did,and had the flu, had a much milder illness. The vaccine program was probably cost effective. Richard A. Guyton cc: J. D. Ong L. Carter B. A. DiLiddo R. A. Eisentrout L. V. Triggiani bcc: H. W. Dietz, M.D. H. E. May, M.D. R. A. Kelley 1 23888002 BFG28456