Document 4Qa0GNwKrmqmxKLk9vK4Ex9wN

H. uj March 20, 1987 J. D. Ong Activities Report - February 1987 Health & Environmental Services Division 1. The annual urine cytology program for 1987 has begun with mailing cards and letters to 106 eligible retired or former employees who had exposure to beta-naphthalamine. The program is designed to provide early diagnosis of can cer of the urinary bladder. 2. At the request of the Vinyl Institute, R. K. Hinderer has provided an update of Medical Committee activities. All of the primate studies with HC1 and PVC have be'en completed. Initial combustion toxicity evaluations with PVC have found a more toxic response with rodents than primates. These studies will be continued until the end of this year. 3. We are continuing to assist the FPD in obtaining pesticide clearances for Promac in a number of countries in Europe and the Far East. We are now gathering information on potential consultants for guidance and liaison activities with the respective countries/agencies. 4. The EPA Pesticide Establishment Report for Promac and No Foul have been submitted to EPA. No 1986 production was shown for either pesticide. For No Foul, BFG is now considered an applicator, not a producer. Our custom mixer is now considered the producer for EPA pesticide purposes. 5. Alza Laboratories wants to use the sodium salt of Carbopol 934-P in a time release cattle bolus application. We will make the C-934-P salt at the Avon Lake pilot plant initially. Alza plans to perform a Good Manufacturing Practice(GMP) inspection at Avon Lake March 11, 1987. In preparation for Alza's inspection, W. C. Bachtel made a similar inspection February 26. He made a number of recommendations to bring the pilot operations into compliance with GMP. BFG28323 U $ 2- - Activities Report - February 1987 Health & Environmental Services Division - contd 6. On February 19 and 20, Walter Lang and W. C. Bac^tel met with Monsanto and the EPA concerning the use of Carbopol 1342 as an inert pestcide ingredient. EPA's policy of approving inert pesticide ingredients has been changed very recently. EPA now requires an extensive minimun chemical and biological data set for all inerts. Exemp tions to the required data are possible. Based on our discussions, we believe we can show that Carbopol-1342 is essentially similar to other acrylates now cleared, and thus obtain an exemption from further testing. It will be at least four to five months before we will obtain any response from EPA after our initial petition is sub mitted. If no exemption is granted, the cost to develop the additional toxicitv data required would be prohibitive for this application. Lever Brothers is interested in the use of Carbopol-934-P in a toothpaste formulation. We have authorized the FDA to refer to the Drug Masterfile on Carbopol-934-P for Lever Brothers' application. cc: Leigh Carter Richard A. Guyton BFG28324 Qo> I\)