Document bO5o0wZXNLY5daoRO9LXEeN4Z

J?. G!eLfr*s V-J $$)' - '-0 DOW CHEMICAL U.S.A. Or>y^^) l^C 1603 Building July 31, 1979 j COrdL 4 /V^H^ MIDLAND. MICHIGAN 48640 JnU^d^LP- 1*3- ~ 0\^u^is&y-^ Yh CMA Vinyl Chloride Research Coordinators/ Dr. Z. G. Bell, Jr. - PPG Xndu pFrrrvgn Dr. T. J. Benya - Ethyl Corp. Dr. W. D. Harris - Uniroyal Inc. AUG 8 1979 Dr. M. N. Johnson - B. F. Goodrich Dr. C. D. Kary - Shell Chemical T "To .opgj L& LOVCrS fiEl Mr. J. T. Seawell - CMA Dr. W. M. Smith - Air Products & Chemicals Mr. R. N. Wheeler - Union Carbide - OC-l^ . - Plc.?1 ,'c cc: J. T. Barr - Air Products & Chemicals P. J. Gehring - Dow USA _ <*** Ujc^V: Ki ^To--- J. Lawrence - SPI R E C -- V...~ orMiNT C. Maltoni, M.D. - U. of Bologna research j 12 . J. M. Norris - Dow USA J. Stafford - ICI, England P. G. Watanabe - Dow, USA \^ I.J- ^ ^ gM^TH I) => ^ >~<? "Jve-u-P7 PREPUBLICATION DRAFT OF CPSC/EDGEWOOD ARSENAL REPORT This somewhat cleaner copy of the subject report, first released April 26, may be of use to you. We will be discussing it at our next Research Coordinators' meeting. 3o v ~7q 5pt ?I It has been indicated that this study may be published in a sci entific journal. We should do all we can to be sure .that the pub lication is an accurate statement. If anyone has information on the time and place of publication, please keep us informed. I'm taking the liberty of including a June 19 letter by John Stafford and a July 19 letter by John Barr, in which they make some comments about the report. I will be glad to get comments from all of you and attempt to coordinate any response to this publication through the CMA, if that seems appropriate. Sincerely yours, T. R. Torkelson, ScD. Chairman CMA Task Group Ends.: (1) CPSC Report (2) Letter by John Barr, July 19, 1979 (3) Letter by John Stafford, June 19, 1979 an operating unit op the oow chemical company GGC 003359 TJeoi--f.c Welwyn Garden 23. ---- (STD Code 07073) Teiex 26-251 Dr J T 3arr Air Products & Chemicals Inc 5ox 533 Allentown Pa 18105 USA < industries Limited Plastics Division Your ref. Our ref Tel ext Date JS/MJE/DS0-107 3162 19 June 1979 Dear John VCM - CPSC STUDY A few weeks ago you were kind enough to send us some information about the CPSC study and news release of the work done at Edgewood Arsenal. We have had professional views expressed on the report and you can guess their tenor from the follcwing:- " (1) The findings which the author claims are important are:- (a) ICR mouse, single dose: Control 1 hour x oO ppm 1 hour x 500 ppm 1 hour x 5,000 ppm 1 hour x 50,000 ppm (b) A/J mouse Control Ten times at 500 ppm (c) A/j mouse Pulmonary adenomas 10% 10.1% 12.9% 16.8% 32.3% Carcinomas O/a Of* 0.7% 0.7% 2.2% 34. 4% 74.7% 3.3% 13.3% Control ICO times 50 ppm 34. 5% 41.1% 2.4% 4.4% I have no t formally carri ad cut o statistical analysis I feel su re that only the- 5C ,000 ppm x 1 hour dose is significc ntly different f:rod' the controls. GGC 00336 (3) Mice o fren have a high incidence of pulmonary adenomas,, The ci og-'osis of these lesions is, to say the least, inexact, Tefore giving cny credarco to the findings, I believ we should Mcve on independent pathologist's opinion on the lesion (4) Pneumonitis wcs diagnosed in the single-dose exposure. It soe.Tis highly unlikely to me that it con hove been the result of exposure to VCM 13 (or 13) months previously. Chemicallyinduccd lesions would have resolved by that time or have presented as chronic, healed Ic-sions. It suggests to me that the mice were suffering from the effects of an infection of the lungs, but that cannot be proved. It may also be that the A/j mice had been infected and recovered. (5) The report by P Steiner and C G Loosli (The effect of human influenza virus (Type A) on the incidence of lung tumours in mice, Cancer Res _1_0 3S5 1950) includes in its summery the following statement: "The infection produced great, tumour like epithelial hyperplasia during the recovery stege. Some influenza-induced lung lesions persisted throughout the life of the animals. These changes did not eventuate in lung tumours in mice of low lung rumour strain C57 black...M (6) I am unable to conclude that there is conclusive evidence presented of a causal relationship between brief exposures to VCM and lung cancer in mice. (7) The technique of multiplying exposure (in ppm) with length of exposure to give a single figure index of exposure seems very strange end I am not prepared to accept the conclusions based.on it. You will no doubt realise from the above comments that, in my opi.* ic.i, the study dees not provide conclusive evidence that VCM C . U -- uced lung tumours in mice. The factors influencing the incidence o f t hese rumours in mice ere imperfectly understood, and even if the pathological diagnoses were confirmed and the lesions were cens idered net due to virus infection, it is doubtful if the resu Its con be considered as definitive evidence that VCM produces care c effects in mouse lungs. 1 do not believe that they indicate that short exposure to VCM is a potential risk to human he a! to, pearing in mind the human epidemiological evidence and the in cc .oclusive nature of the experimental evidence; " I have discussed these comments with our professionals at the Central TTooxxiiccoolloogy Laboratory and they have asked me to get in touch with you to "ind out what the American industry is doing about this report, eith er 'ia t.ne oPI or the MwA. Is the U5 PVu industry going to ignore the report? Are you going to publish any comment? Bave you feci.aed~ Tor"examp 1 e, tlT' get in tcLch with the researchers to discuss the significance and also to look ot the path slides along with the Edgewaad Arsenal pathologist. I would be grateful if you would let ms know what action, if any, you ere proposing rc take. One of the thoughts thet wcs in our minds was that yo^u .2 cccided.! j._--_ Jd. _o_ n__o__th__i_n^g_ w..e. mig_lhit .w__i_s__hi__ jt__ow_ _h_a^_v_e_ one ofr our potnclogis :s cr consulting pathologists visit Edgewood Arsenal to discuss tie report `^` 4* . i 4u` !:-.tp-i ij. * a ic nii o A *, ] I'-l L w. tfrJe r-I ta ask for views and the first reaction I got v a "how caul J onvone Jc- such work", and the second comment * a^ ,-v * *L> --) , i or cur Jritish inruscricl and Biological Research Ac satiation was "as an exerciss in fatuity it (the CPSC report) would " a <e sc r e b eating" tiucr. comments ers oil very well but cddly enough GGC 003361 i>e ora getting some queries from members of the press about this one shot business end they don't seem to want to drop their probing. Our orofessioncls also tell me it is not all that uncommon for chemicals which are known to be carcinogenic to produce effects after single exposure. There ore a number of studies with nitrosanines and aflatoxins which demonstrate this effect. Has the US press continued to take an interest in the CPSC Press Release or has the interest vanished? I am sorry to load you with so many questions but I would be grateful for your help ond guidance. Yours sincerely J Stafford Division Manager Health & Environment Protection cc Dr T R Torkolson, Dew Mr % M .'heeler, UCC Mr M J S Gibbons, ICI Ar.ericcs GGC 005362 Air Products and Chemicals. Inc. Box 533. Allentown, PA 18105 (215)398*4911 19 July 1979 Mr. John Stafford Division Manager Imperial Chemical Industries P. 0. Box No. 6 Bessemer Road Welwyn Garden City Hertfordshire A17 1HD Dear John: I have just returned from vacation to find your letter of 19 June on my desk. For the past three weeks, I have played with my grandson and gone boating in Lake Michigan and now you bring me back to dead mice. I also find that Ted has responded to your letter telling you of some of the actiors which the CMA is taking. I am very happy that he's acting here, because several weeks ago it was agreed that as between the AiHC and the SPI that the latter organization would take the lead, however, all they did was to protest mildly to the CPSC and nothing was done in public. ------------ ---------------- The matter which seems to me to have received inadequate attention is the contrast between the published conclusions of the author on page 19 and the press release which was prepared by the CPSC. The former said that no cancer was caused by this experiment and the latter said that there v/as. I strongly urgedthe SPI simply to send these two items to several science writers for their action, but this v/as not done. I am very dis appointed that the agency was permitted to revise scientific results for their own publicity purposes. It is immaterial whether or not a single dose produced cancer. As you point out, this phenomena is well known with other carcinogens. I am afraid that this has been overlooked by those who may have thought about replying and that the only consideration was whether or not a scientific attack should be made on the paper. This would have been a most improper action. I have not heard of any further publicity on this point for nearly two months now. As far as I know, nothing is being done other than what was in Ted's letter. You should, of course, feel free to do anything which you think is wise. The paper is supposedly out for review at this time and thus, if and when it receives formal publication, the whole subject, may reawaken. At that time, the SPI may feel more inclined to act. I can not predict what will happen then. GGc 00336.? Mr. John Stafford Page 2 19 July 1979 My thanks for your efforts in exploring this subject and, I am sorry I could not give you more definitive news. We will keep you advised if anything further developes. If you or Ted really want some warm weather as you profess, I advise you to visit my daughter in Oklahoma City. It was over 100 degrees several days in a row while I was there and that is enough summer for me this year. 0TB:cmk cc: Dr. T. R. Torkelson, Dow^ Mr. R. N. Wheeler, UCC Mr. M. J. S. Gibbons, ICI Americas Mr. 0. Lawrence