Document rxav0280ypQJqxywea35YBB5a

1603 Building July 31, 1979 DOW CHEMICAL U.S.A. MIDLAND. MICHIGAN 48640 CMA Vinyl Chloride Research Coordinators: Dr. Z. G. Bell, Jr. - PPG Industries Dr. T. J. Benya - Ethyl Corp. Dr. W, D. Harris - Uniroyal Inc. Dr. M. N. Johnson - B. F. Goodrich Dr. C. D. Kary - Shell Chemical Mr. J. t. Seawall - CMA Dr. W. M. Smith - Air Products & Chemlc. Mr. R. N. Wheeler - Union Carbide __j cc: J. T. Barr - Air Products & Chemicals P. J. Gehring - Dow USA J. Lawrence - SFI C. Maltoni, M.D. - U. of Bologna J. M. Norris - Dow USA J. Stafford - ICI, England P. G. Watanabe - Dow, USA 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. 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 ia 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 OP1AAT1NQ UNIT OS TH* DOW CHCMtCAi. COMPANY ucc 002422 Rosd V.cW-yt' Garden City Hertfordshire AL.71HD ; uV.`,i.coe We.wyn Garden 23400 (STD Cods 07073) Te.e* 264251 r J r 3orr ^ir Products & Chemicals Inc ?ox 533 -Mlentown Pa 13105 USA I Chemical Industries Limited Plastics Division Your ref Our ref Tel ext Date JS/MJE/DSO-107 t'-ear John 3162 19 June 1979 VCM - CPSC STUDY A few weeks ogo 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 ond you can guess their tenor from the following:- " (l) The findings which the author claims are important are:- (a) ICR mouse, single dose: Control 1 hour x 50 ppm 1 hour x 500 ppm 1 hour x 5,000 ppm 1 hour x 50,000 ppm (b) A/j_ mouse Pulmonary adenomas 10# 10.1# 12.9# 16.8# 32.8# Carcinomas o# 0# 0.7# 0.7# 2.2# Control Ten times at 500 ppm (c) A/j nouse 34.%# 74.7# 3.3# 13.3# - Control ICO times 50 ppm 34.5# 41.1# 2.4# 4.4# (2J I hove not formally carried out o statistical analysis, but I feel sure that only the 5C,C00 ppm x 1 hour dose is sign!ficantiy different from the controls. (3) Mice ofcen have a high incidence of pulmonary adenomas. Wne diagnosis of these lesions is, to say the least, inexact, cefore giving cny crudance to the findings, I believe we snoulc neve an independent pathologist's opinion on the lesions. ucc 002423 2 (4) Pneumonitis was diagnosed in the| single-dose exposure It seems highly unlikely to me that it can have been the result of exposure to VCM 13 (or 13) months previously. Chen icallyinduced lesions would have resolved by that time or huve presented as chronic, healed lesions. It suggests to me that the mice were suffering from thd effects of an infect:,on of the lungs, but that cannot be pifoved. 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 df human influenza virus (Type A) on the incidence of lung tumoiurs in mice. Cancer Res 10 385 1950) includes in its summary the following statement: "The infection produced great, tumourlike epithelial hyperplasia during the recovery stage 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 tumour strain C57 black..." (6) I am unable to conclude that there is conclusive evidence presented of a causal relationship between brief exposures to VCM and lung concer 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 and I am not prepared to accept the conclusions based.on it. You will no doubt realise from the above comments that, iri my opinion, the study does not provide conclusive evidence that VCM produced lung tumours in mice. The factors influencing the incidenc of these tumours in mice are imperfectly understood, and tiven if the pathological diagnoses were confirmed and the lesions were considered net due to virus infectio it is doubtful if the results can be considered as definitive evidence that VCM produces carcinogenic effects in mouse lungs. I do not believe thet they indicate that short exposure to VCM is a potential risk tc> human health, bearing in mind the human epidemiological evidence and the inconclusive nature of the experimental evidence. " I have discussed these comments with out professionals at the Central Toxicology Laboratory and they have asked me to get in touch wi th you t find out what the American industry is doing about this report, eith r via the oPI or the MCA* Is the US PVC industry going to ignore the report? Are you going to publish any comment? i-Jcve you decided, for txarnpl , t get in touch with the researchers to discuss the significance and als to look at the path slides along with the Edgewood Arsenal pathologist I would be grateful if,you would let ms know what action, if ciny, you are proposing to take. One of toe thoughts that was in pur minds was that ir you hod decided to do nothing we might wish to have one of our pathologists or consulting pathologists visit Edgewood Arsenal to discuss the report with them. I did else go outside ICl to ask for views and the first read ion I got from 'loltoni was `'how could anyone do su|ch work"; and the seccend comm nt from the director of our 3ritish Inoustrial and Biological Res-earch Association was "os an exercise in fatuity it (the CPSC reporf ) would take sofi beating". Such comments ere all very well but oddly enough UCC 002424 3 we are getting some queries from members of the press about this one shot business and they don't seem to want to drop their probing. Our professionals clso tell ms it is not all that uncommon for chemicals which are known to be carcinogenic to produce effects after single exposure. There are o number of studies with nitrosamines 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 and guidance. Yours sincerely J Stafford Division Manager Health & Environment Protection cc Dr T R Torkelson, Dow Mr R N ..'heeler, UCC Mr M J S Gibbons, ICI Americas I UCc 00242s Air Products and Chemicals. Inc. Box 538, Allentown. PA 18109 (319)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 actions 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 A1HC 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 th 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 was. I strongly urgedthe SPI simply to send these two Items to several science writers for their action, but this was 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. UCC 002426 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. JTB:cmk cc: Or. T. R. Torkelson, Dow^ Mr. R. N. Wheeler, UCC Mr. M. J. S. Gibbons, ICI Americas Mr. J. Lawrence UCC 002427 DEPARTMENT OF THE ARMY US ARMY ARMAMENT RESEARCH AND DEVELOPMENT COMMAND CHEMICAL SYSTEMS LABORATORY ABERDEEN PROVING GROUND. MARYLAND 21010 DRDAR-CLB-T 13 July 1979 fed Torkelson H&ES 1603 Building Dow Chemical Company Midland, Michigan 48460 Dear Mr. Torkelson: Inclosed is a copy of the pre-publication report on vinyl chloride which you requested. Sincerely, 1 Inclosure as stated B.P. McNAMARA, Ph.D. Chief, Toxicology Branch UCC 002428