Document XOy7jxY7V7NQBNwz3gkw817bw

*4 /' * Manufacturing Chemists Association Minutes of Meeting Vinylidene Chloride Technical Panel MCA Conference Room April 21, 1976 Washington, D.C. The meeting was convened at 9:30 a.m. by Chairman Bell. The record of attendance is: MEMBERS PRESENT: Z. G. Bell, Jr., Chairman V. C. Bachtel (for M. N. Johnson) E. J. Kerfoot (for R. Jadrnicek) J. R. McDonough J. M. Norris W. A. Patterson R. J. Turner P. J. Vanderhorst P. L. Wright MEMBERS ABSENT: PPG Industries, Inc. B. F. Goodrich Chemical Company BASF Wyandotte Corporation Tennessee Eastman Company The Dow Chemical Company W. R. Grace & Co. Morton Chemical Company E. I. du Pont de Nemours & Company Monsanto Company W. V. Andresen H. A. Cantor A. Konishi L. Rapoport J. M. Smith J. Yamada GUESTS PRESENT: American Cyanamid Company Staley Chemical Kureha Chemical Industry Co., Olin Corporation Rohm and Haas Company . Asahi-Dow Limited Ltd. W. R. Hoopes J. P. Lyon C. C. Kazmierski W. R. Grace & Co. E. I. du Pont de Nemours & Company The Dow Chemical Company l/ >I 02758 sd VDCTP-30 1. Last Meeting The minutes of-the January 7, 1976 meeting were approved as distributed. 2. Financial Status The Project Manager summarized the financial statement of April 12, 1976, a copy of which is attached. 3. Toxicology Subcommittee 3.1 Studies in Progress The two year inhalation study was terminated February 23 on schedule. Dr. Norris reported. It was not carried further as anticipated earlier since ninety percent mortality was reached in one of the groups and this was the pre viously agreed on criterion for ending the study. An interim report is due in May and to this point in time there have been no untoward findings. A final report, including pathology, is expected in about one year. 3.2 Additional Studies Proposed 3.2.1 Dow Studies 3.2.1.1 Teratology Study Dr. Norris reported that in the three generation reproduction study with rats exposed to VDC by inhalation, mortality in the F3A generation has been statis tically higher than for controls. This is difficult to explain in view of the absence of toxic effects in the earlier part of the study. A low fertility rate in the Fj generation was thought to be unrelated. Since the data to this point is anomalous it would be desirable to try to determine whether the high mortality in F3A is an artifact. The approach recommended by the Subcommittee and approved unanimously by the Panel is to proceed to F3B and F3C generations whether an effect is noted or not. In addition, if an effect is noted in F3B, the F4A generation should be bred and observed. The total cost for this work is expected to be in the range of $20,000 to $24,000 and will be proposed to management contacts. SL 027859 VDCTP-31 3.2.1.2 Wavy Rib Observations To further investigate this phenom enon, discussed at some length last meeting, Dr. Norris proposed the following three part study which this Subcommittee recommend ed for approval to the Panel: 1. $ 2,620 2. $14,960 3. $16,170 $33,750 Two Probe Studies Post Natal Study (to determine reversibility) Determining No Effect Level Total The Panel voted unanimously to recommend to Management Contacts that these studies be under taken at Dow with the understanding that one of them may be dropped if it is deemed to be infeasible in view of the data in hand at the time. Dr. Norris will keep the group posted. 3.2.1.3 Determination of No Effect Level by Inhalation The Subcommittee plans to review this proposed multiple species shudy prior to the next Panel meeting so that it may make a recommendation at that time. 3.2.2 Dr. Laseter's Research Dr. Bell reviewed the brief history of the application of the extremely sensitive analytical techniques developed at the University of New Orleans to biological phenomena. The potential of this method in identifying changes in metabolic pathways and providing an early warning system in humans was stressed. Dr. Patterson who visited Dr. Laseter in the company of w. R. Grace's consultant. Dr. Hodge, agreed to proceed with this type of investigation only if comparative data with other materials were made available. Dr. Bell also mentioned that the National Cancer Institute is very much interested in exploiting the possibilities of this ultrasensitive technique. Reporting the results of a letter ballot, the Project Manager indicated a majority of the Toxicology Subcommittee did not favor supporting this type of research. After some discussion, the Panel voted (seven to two) to drop the proposal to support the type of work being conducted by Dr. Laseter. Sb 0 VDCTP-32 3.3 Report on EPA Sponsored work at the Midwest Research Institute, (MRI) Dr. Norri's indicated the data from MRI so far on embryo lethality is very hard to interpret since it is not consistent. A report on MRI's interim results obtained by Dr. Norris will be distributed to the Panel. 4. Analytical and Monitoring Subcommittee Dr. Patterson reported on behalf of Dr. Pike, (Chairman of this Subcommittee), that a method had been developed for the determination of EDC in air. In Round Robin testing it was found to have good accuracy and precision. Currently it is being re written in final form by Mr. Cobler of Dow. The Project Manager further indicated this Subcommittee would like eventually to offer it to ASTM and have it published in a suitable scientific journal. The group felt it should first be approved by the Panel after the Work Practices Subcommittee has commented on it and incorporated the method into the Work Practices document they are preparing. It was further noted that the Analytical Subcommittee had developed methods for monomer in latex as well as in powder. They had decided to defer work on simulated food solvents with films until FDA has established proposed allowable levels since the analytical approach used will be dependent on them. Lastly, the Analytical Subcommittee recommended to the Panel deferral of the proposal of Dr. Gilbert of Rutgers until feeding studies now underway and planned are completed and a no effect level has been established. 5. Work Practices Subcommittee Mr. Hoopes pointed out that the most recent work practices document this group prepared had been distributed to the Panel along with comments received. However, rather than discuss these individually, it was agreed that the Subcommittee prepare a re vised document for presentation to the Panel at the next meeting. 5.1 Proposed Submission of Work Practices Document to NIOSH This suggestion was made in response to a request for information by that agency. The Panel voted unanimously to SL 027861 VDCTP-33 defer a decision on what to do with the work practices document until it is in hand. 6. Medical Surveillance Subcommittee Points made by Dr. Kerfoot regarding BASF Wyandotte's South Kearny plant situation are as follows: 1. The unions, (Rubber Workers and Oil Chemical and Atomic Workers) continue to associate the abnormal liver functions found among some workers at that plant with vinylidene chloride. The Company position is that the observations could be ascribed to any of several hepatotoxins at the plant. There has been some interference from NIOSH and The United Rubber Workers, who rep resent the workers at this plant, in completion of the biopsies recommended by the liver specialist called in as a consultant by the Company. 2. Difficulty is being encountered in finding a suitable control group for comparison with the workers examined. To help evaluate the epidemiological situation, the Company has engaged Dr. Clark Cooper of Equitable Environmental Health, Inc., (form erly Tabershaw-Cooper Associates). 3. Dr. Norris said Dow has good data on exposure con centrations and health histories dating back to 1944, showing no adverse effects. Dow intends to publish this information. 4. NIOSH has taken over one hundred samples at the plant in question and they have all been under one part per million of VDC. Dr. Kerfoot suggested that the medical surveillance procedure for VDC should be reexamined carefully in view of BASF's experience. 5. recently. The VDC operation at South Kearny was shut down 6. An appeal was made by Dr. Kerfoot to have companies with relevant medical data transmit it to him. 7. Report on International Agency for Research on Cancer, (IARC) The thrust of Dr. Clary's report, read to the group by Dr. Vanderhorst, is that the IARC Committee felt there was insufficient information at this time to prepare a monograph. A preliminary draft including chemical, physical and biological data was written and will be distributed to the Panel along with SL 027862 VDCTP-34 Dr. Clary's letter of April 6. 8. Next Meeting September 16 was selected as the date for the next meeting in Washington, D.C. In addition, it was agreed the Toxicology Subcommittee would meet at 1:00 p.m. on September 14 and the Worh Practices Subcommittee at 2:00 p.m., September 2. Sincerely, MF: ec May 7, 1976 Minutes subject to approval Milton Freifeld 0 Project Manager Vinylidene Chloride Research SL 027863