Document Gzvpe6npdXbgQX1rJJYKdp0ev

March 5, 1987 R. A. Guyton, M.D. Activities Report - February, 1987 Environmental Health/Industrial Hyqiene/Toxicology 1. Dr. Dietz, Mr. Modrell, Ms. Dillon and Ms. Pearcy continue to devote significant time to developing and entering documents into the HYTOX system (MSDS) which now contains over 1,400 records. Sets of MSDSs were provided to the Los Angeles Service Center and to the Modesto Plant. Interest in the system continues to grow; there are numerous requests for additional sets of MSDSs; two plants have requested indices for the entire system rather than just their own plant. Chemical Division has asked to use the system for compliance with SARA (Superfund Amendment and Reauthoriza tion Act); and we have been able to use various printouts to ease our own task of editing and updating. Ms. Dillon provides Mr. Katzenmeyer, UGT, with weekly updates and has provided him with a complete index. 2. We have received the draft report on the NTP cancer bioassay of MBT. NTP has concluded that there is "some evidence" of cancer based on these results. Since the Science Advisory Board is scheduled to review this study in March, Dr. Hinderer met with other representatives of the CMA Rubber Additives Panel to critique this document. These comments will be provided to the SAB and to the EPA during the test rule development process. We are in a particularly difficult position. If we are successful in convincing the Agency that the data are equivocal then repeat long-term testing ($800,000 - $1,000,000 additional cost) may be required of industry. On the other hand, NTP's present conclusions are likely to be used to support the need for further testing of other rubber chemicals. 3. Mr. Modrell consulted with Dan Dimas regarding the use of 2-ethoxyethanol in Akron Aircraft Tires. This is one of the. glycol ethers linked to adverse reproductive and developmental effects in animals. OSHA will shortly issue a restrictive standard on its use. He also discussed with Dan Dimas the results of Liberty Mutual solvent monitoring at the A&DD facility in Phoenix, Arizona. Excessive exposures were reported for MEK and toluene but monitoring times were of short duration. D. Dimas will instruct the plant to remonitor exposures on a TWA basis. Mr. Modrell assigned safety ratings and updated thirteen HYTOX MSDSs that were requested by UGTC. Kj 8 O BFG28354 4. A meeting of the IISRP EH Committee was held this month. Dr. Hinderer presented an update of Institute activities regarding OSHA rulemaking on BD. Dr. Hinderer was also a speaker the following day at an Institute seminar on BD. An overview of health issues and regulatory activities was provided. Dr. Hinderer attended a joint CMA/IISRP meeting on BD. The purpose of this gathering was to develop recommendations on which toxicology and epidemiology studies on BD and SBR would be valuable. A wide range of studies were identified. Once the initial draft of this work has been prepared, efforts will be made to prioritize these studies and to estimate their costs. 5. Mr. Bachtel attended an EPA acrylates meeting February 3. The meeting was called by EPA to identify and discuss health issues that may be presented by the "acrylate category" (i.e. acrylates or methacrylates containing ester groups). EPA may be proposing Significant New Use Rules (SNUR) for these substances. EPA's main concern is occupational exposure. Since OSHA has no acrylate standard and could take years to develop one, EPA feels they must act to fill a perceived void. An industry group is forming to coordinate future actions to EPA's proposals. 6. On February 19 and 20, Walter Lang and Mr. Bachtel met with Monsanto and the EPA concerning the use of Carbopol 1342 as an inert pesticide ingredient. EPA's policy of approving inert pesticide ingredients has been changed very recently. EPA now requires an extensive minimum chemical and bio logical data set for all inerts. Exemptions 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 submitted. If no exemption is granted, the cost to develop the additional toxicity 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. BFG28355 Z0098S<5 -3- 7. 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, Mr. Bachtel made a similar inspection February 26. He made a number of recommendations to bring the pilot operations into compliance with GMP. USP-NF received and is reviewing the toxicity data we sent on Carbopol 934 and 934-P. The USP committee reviewing testing and impurity limits is to meet March 3 and may consider the proposed benzene limits. 8. 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. 9. 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. 10. Mr. Bachtel attended the NSF Drinking Water Additives Health Effects Task Group meeting February 5 and 6. The NSF peer review group gave favorable comments on the proposed guidelines to date. As a test of the sensitivity of the guidelines some water additive chemicals were "walked" through them. The guidelines, as drafted, appear to be able to discriminate substances of concern, in fact, more than necessary, at extremely low levels. During the ensuing discussion he questioned the need for any toxicity require ments for contaminants likely present in drinking water below 10 ppb. After prolonged discussion, the numerical levels triggering increased toxicity level were shelved for now. Refinement of the remainder of the guidelines was pursued. The resultant guidelines without "trigger" levels will be presented to the NSF peer review group for their written comments before the next meeting of the Health Effects Task Group. 11. At the request of the VI, Dr. Hinderer has provided an update of Medical Committee activities. All of the primate studies with HC1 and PVC have been 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. BFG28356 atoass? -4- 12. Dr. Hinderer conducted an audit of the Genetic Toxicology Laboratory at Brecksville. Data on many of our products were reviewed and found in order. In general the Labora tory appears to be operating in a satisfactory manner. 13. Mr. Modrell attended BFG's Safety Managers' meeting in Independence. Present were Herman Waltemate, Tom Bialke, A1 Timpano, Tom Krena and Dan Dimas. Status of the HYTOX MSDSs for the chemical plants was discussed in detail. 14. The following activities involved the Medical Surveillance System and Ms. Butterfield. a. The annual Mortality Program was processed. b. Individual cotton dust exposure reports for all effected employees were successfully generated and sent to Martha Mills the first of this month. c. We continue to support J. LaCava in Worker's Comp, with requested medical, diagnostic and job histories. d. Entry of medical examination to the CMS system are current to the last week in February. Entry will resume after the move to Bath. e. 3,776 records were entered to the CMS (BFG) system. Two Metpath tapes and two Health Examinetics tapes were also processed. f. Since the JMS (UGT) system has not been updated, an accurate record count is not available. The following is a breakdown of record groups received and entered on-line for UGT this month. Audiograms only - 130 Full physicals - 28 Pulmonary functions and audiograms - 36 Cotton physicals from Martha Mills - 106 Exposure monitoring cards - 82 15. The Urine Cytology Program is underway with 106 cards and letters sent to retired and former employees eligible to participate. 16. Industrial hygiene monitoring equipment was transferred to Department 1851 and UGT 6018 in preparation for the move to Bath. 17. Testing of the Basis and Medical Surveillance systems on the Bath computer was conducted successfully and we anticipate no problems in the move to that hardware. BFG28357 tn)09S8T? -5- 18. Because of space limitations, industrial hygiene files are being moved to record retention rather than being retained as before. This will make future record searches more difficult and time-consuming, but appears to be a necessary step. 19. A letter has been sent to both NIOSH and NTP requesting the deletion of Estane 5703 as a synonym for "urethane" (ethyl carbamate) from the Register of Toxic Effects of Chemical Substances and the next Annual Report on Carcinogens. This results from the recent publicity regarding "urethanes" in alcoholic beverages. Harold W. Dietz DP S009S8S