Document k64jVax8kdEL6NrGEM4B21orq

* CHEMICAL MANUFACTURERS ASSOCIATION May 7, 1980 Mr. Richard L. Davis Director Health Management Services Environmental Health Associates, 2150 Shattuck Avenue Suite 414 Berkley, California 94704 Inc. Dear Mr. Davis: The following summary is being presented in order that a revised or modified bid/proposal can be prepared by Environmental Health Associates, Inc., (EHA) that reflects recent action of the Vinyl Chloride Panel and Research Coordinators, wherever possible, Panel actions are summarized according to major sections of your bid/proposal of January 15, 1980. To facilitate subsegu nt reference, the following sections and subsections are numbered:. 1.0 Evaluation of the Current Data Base 1.1 In the light of our recent discussions it appears advisible that at the earliest possible time EHA give the Panel a written opinion on the exact current status of the data base. As you indicated, before a "Brain Case Control Study" or a "FiveYear Epidemiological Update" can be conducted, the data base must be augmented. 1.2 Panel action relevant to EHA's assessment and/or evaluation of existing data was as follows: "We agree that Environmental Health Associates (EHA) be authorized to examine the current records, prepare a protocol for a five-year update, and conduct a reanalysis of death certificates according to the EHA letter pro posal dated January 15, 1980." 2.0 "Brain Case Control Study" (BCCS) 2.1 After EHA has completed necessary assessment of the data base that pertains to the BCCS, the Panel con firmed its earlier position by voting: EHA will be requested to prepare a protocol and a cost estimate for a "case control study" of Formerly Manufacturing Chemists Association--Serving the Chemical Industry Since 1672. IP**6 Connecticut Avenue NW Washinoton DC 20009 Telephone 202/328-4200 Telex 89637 (CMA W.' 0133 2 cancers of the central nervous system. 2.2 The Panel confirmed an earlier stipulation that the protocol prepared by EHA for the BCCS will be open for bids in addition to the EHA bid. 3.0 Study Plan A 3.1 The Panel is in agreement on proceeding with Study Plan A described on pages 6, 7 and 9 of EHA's letterproposal dated January 15, 1980. 3.2 As you reemphasized during your telephone call of May 6, 1980, the development of an accurate estimate of the probable cost to perform the five-year follow up requires more precise information than is now available. 4.0 Study Plan B Introductory Comment As discussed with you, the following summary of Panel action on study Plan B is presented in an effort to assist you during the preparation of your modified bid/proposal. The preceding comment is relevant because the Panel voted to hold Study Plan B` in abeyance for consideration at a future date. 4.1 Study Plan B should be modified by identifing the plants as follows: Group I - Vinyl Chloride Monomer Group II - PVC By Dispersion or Emulsion Processes Group III - All Others 4.2 Under Study Plan B, EHA is to be requested to clarify the comment "...secure complete job histories for the approximate 3,300 cohort members with incomplete job histories". EHA is to characterize the deficiencies that exist in these 3,300 cohort members. 5.0 Study Plan C Panel members expressed the opinion that there is little likelihood that Study Plan C will contribute anything new. They estimated that Study Plan C will not yield meaningful data until 10, 20 or perhaps 25 years hence. 6.0 Request for EHA's "Opinion and Position" on Mortality Study Based on Type of Plant Production The Panel requests that EHA present its "Opinion and Position" on analyzing data in terms of those plants pro ducing : EPL 01335 3 (1) Vinyl Chloride Monomer (2) Emulsion or Dispersion Polymers (excluding latex), (3) All Others The analysis (s) to treat "significant differences with respect to mortality at a cost not to exceed $10,000". Please contact me immediately should any item in this letter need clarification. Sincerely, JTS :md cc: DDr. H. C. Shah Dr. T. R. Torkelson J. T. Seawell Staff Advisor Vinyl Chloride EPL 01336 TABLE I TEST MATERIAL: Vinyl Chloride {Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice, and Golden Hamsters Chamber Concentration Data Day Number 1 4 5 16 29 39 56 73 80 99 120 130 150 151 152 171 186 187 197 200 201 208 212 220 221 229 232 235 Exposure Number 1 4 5 12 21 29 48 53 58 71 86 94 108 109 110 123 134 135 141 144 145 150 152 158 159 165 166 169 TE-I Ranae Mean 39 45 50 42 48 42 48 42 45 29 45 42 35 32 41.5 35 47 46.5 40 38.5 37.5 48 36 36.5 44.5 46.5 47 44 45 43 54 51 56 52 63 60 66 58 55 43 114 84 58 49 60 54 31 -- 30 46 45 63 53 58 49 62 44 110 58.9 55 48 53 49.6 55.5 50.7 55 45.1 56 49 55.5 48 54.5 51.4 64.5 48.1 52.5 45 55 49.2 46 49.4 71 52.3 51 47.6 Chamber. Concentration (ppm) TE-I I TE-III Ranae Mean Range Mean 130 180 173 24 162 87 182 237 218 54 266 156 192 248 219 188 216 209 172 452 298 178 211 202 220 364 243 258 310 277 168 232 199 180 228 201 90 288 200 150 234 193 170 232 . 198 186 210 197 184 224 209 180 262 194 178 216 196 178 310 223 174 212 197 170 242 200 154 282 194 138 250 192 130 138 134 190 216 200 184 228 201 196 215 207 1820 1190 1160 2400 1090 1900 2240 2380 2020 2740 1960 2680 1780 1280 2300 2320 2040 2180 2400 2340 2340 2260 2160 1440 2460 2420 2100 2440 2610 3600 3100 3100 2490 3010* 4000 2700 2760 3940 2960 3100 2920 2800 2800 3020 2680 3400 2700 3120 2740 3420 3200 2600 2620 2800 2820 3710 2510 2540 2202 2653 1561 2455 2910 2565 2404 3185 2565 2883 2556 2349 2497 2708 2419 2550 2535 2561 2500 2627 2583 2240 2540 2583 2520 2932 TE-IV** Range Mean EPL 01357 TABLE I continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Chamber Concentration (ppm) Day Exposure TE-I TE-II TE-III T-IV** Humber Number,RangeMeanRange MeanRangeMeanRange Met 248 178 47.5 52.5 51.2 186 222 203 2420 2700 2573 274 196 44.5 51 47.9 188 216 202 2180 2580 2377 275 197 38 56 49.5 174 242 198 2160 2640 2386 281 201 40 56 47.5 168 232 204 2360 2740 2515 304 218 45.5 50. 5 48.2 202 226 218 2140 2460 2288 312 224 39 46 42.8 148 172 160 1800 2040 1920 315 225 37 52.5 44.2 146 196 174 1800 2440 2073 316 226 46 55 54 182 220 208 2080 2500 2473 318 228 46.5 52.0 49.2 170 280 192 1960 2380 2022 32 3 231 49.4 62 54.9 176 250 208 2160 2840 2475 332 238 56 56 56 206 208 208 2260 2380 2300 333 239 47.5 55 51.3 185 210 202 2160 2600 2556 339 243 40 60 48.9 184 234 203 2380 2960 2607 345 247 49.5 51 50 190 210 203 2140 2620 2525 351 251 35 45.5 39.5 180 246 - 228 2640 2900 2783 359 257 46 71 56 202 208 206 2420 2560 2487 360 248 44.5 59.5 50.7 170 216 202 2360 2840 2602 ^Previously reported by IBT as 1970-2770, with a mean of 2474 **Only gross inspections were made of the TE-IV concentrations but the same problems existed with this concentration as with the others. epl 01358 TABLE II IBT No. 663-03222 VTNYL CHLORIDE RATS - SURVIVAL T-XII - 2,000 ppm Month 5 Report Printout 6 Report Printout 7 Report Printout* 8 Report Printout 9 Report Printout 10 Report - Printout 11 Report Printout 12 Report Printout 13 Report Printout** Male 97 96 95 96 94 89 or 92 90 89 84 82 ' 76 74 66 62 42 37 27 23 Female 96 95 96 94 95 92 92 90 85 81 72 68 48 46 34 15 (?) 17 5 (?) * None of #'s or weights agree with report ** All over the lot, 5 body weights shown EPL 01359