Document 06vv0RwV35Yqv4ZjaL01xOK2m

L? !r DOW r.HFMinAi 11 r,a. 7_y / 1603 Building July 31, 1979 MIDLAND. MICHIGAN 48640 C, PS C* j CMA Vinyl Chloride Research Coordinators: Dr. Z. 6. Bell, Jr. - PPG Industries Dr. T. J. Benya - Ethyl Corp. Dr. W. p. Harris - Uniroyal Inc. Dr. M. N. Johnson - B. F. Goodrich Dr. C. D. Kary - Shell Chemical Mr. J. T. Seawell -- CMA Dr. W. M. Smith - Air Products & Chemicals Mr. R. N. Wheeler - Union Carbide cc: J. T. Barr - Air Products & Chemicals P. J. Gehring - Dow USA J. Lawrence - SPI 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 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. URL 16207 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 DOW CHEMICAL COMPANY Be^^r.er Road Welwyn Garden City Hertfordshire AL7 WO Tcieohone Weiwyn Garden 23400 (STD Code 07073) T<='cx 264ud1 r J T Barr Air Products & Chemicals Inc 3ox 538 Allentown Po 18105 USA Chemical Industries Limited Plastics Division URL 16208 Your ret Our ref Tel ext Dale JS/mjE/DSO-1 07 3162 19 June 1979 Ceor 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 ond you can guess their tenor from the following:- " (1} The findings which the author claims are important ore:- (o) ICR mouse; single dose: Pulmonary adenomas Corcinomos Control 1 hour x 50 ppm 1 hour x 5G0 ppm 1 hour x 5,000 ppm 1 hour x 50,000 ppm loss 10.1# 12.9* 16.8# 32.8# Q# 0# 0.7# 0.7# 2.2# (b) A/j mouse Control Ten times at 500 ppm 34.*# 74.7# 3.3# 13.3# (c) A/j mouse Control ICO times 50 ppm 34.5# 41.1# 2.4# 4.4# (2) I hcv e not formally carried out o statistical onolysis, but I feel sure that only the 50,000 ppm x 1 hour dose is significantly different from the controls. (2) Mies often hove a high incidence of pulmonary adenomas. Tno dieg-.osis of these losiors is, to say the least, inexact, jefero giving cny crcdance to the findings, I believe we s/iould neve on independent pathologist's opinion on the lesions. 2 (4) Pneumonitis was diagnosed in the singie-dose exposure. It seems highly unlikely to me that it can have been the result of exposure to VCM 13 (or 13) months previously. Chemieollyinduccd lesions would hove resolved by that time or have presented as chronic, heaiec lesions. It suggests to me that the mice were suffering from the effects of an infection of the lungs, but that connot be proved. It may also be that the a/j' mice had been infected ond recovered. (5) The report by P E Steiner and C G Loosli (The effect of human influenza virus (Type A) on the incidence of lung tumours in mice. Cancer Res JO 385 1950) includes in its summary the following statement: "The infection produced great, tumour like epithelial hyperplasia during the recovery stage. Some influenza-induced lung lesions persisted throughout the life of the animals. These chonges did not eventuate in lung tumours in mice of low lung tumour strain C57 black. (6) I am uncble 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 o single figure index of exposure seems very strange ond I om not prepared to occept the conclusions based .on it. You will no doubt realise from the obove comments thet, in my opinionjr the study does not provide conclusive evidence that VCM produced lung tumours in nice. The factors influencing the incidence of these tumours in mice ore imperfectly understood, end even if the pathological diagnoses were confirmed ond the lesions were considered net due to virus infection, it is doubtful if the results can be considered as definitive evidence that VCM produces carcinogenic effects in mouse lungs. I do not believe that they indicate that short exposure to VCM is a potential risk to human health, bearing in mind the human epidemiological evidence ond the inconclusive nature of the experimental evidence. " I have discussed these comments with our professionals at the Central Toxicology Laboratory and they hove asked me to get in touch with you to find out what the American industry is doing about this report, either via the iPI or the MCA. Is the US PVC industry going to ignore the report? Are you going to publish ony comment? Have you decided, for example, to get in touch with the reseorc.hers to discuss the significance ond olso to look ot the path slides along with the Edgewood Arsenal pathologist. I would be grateful if you would let ms know what action, if ony, you are proposing tc take. One of the thoughts that wos in our minds wos that if you hod decided to do nothing we might wish to have one of our pathologists cr consulting pathologists visit Edgewood Arsenal to discuss the reoert with them. I did cite go outside 1CI to ask for views and the first reaction I got from 'icltoni was `now could anyone do such work"; ond the second comment from the director or cur 3ritish Industrial and Siologicol Research Association was "os an exercise in fatuity it (the CPSC report) would take sere beating". Such comments ere all very well but oddly enough URL 16209 l 3 we are getting some queries from members of the press about this one shot business ond they don't seem to want to drop their probing. Our professionals clso tell me it is not oil that uncommon for chemicals which are known to be carcinogenic to produce effects after single exposure. There are a number of studies with nitrosamines and oflotoxins which demonstrate this effect. Has the US press continued to take an interest in the CPSC PressRelease or has the interest vanished? 1 am sorry to load you with so mony questions but I would be grateful for your help and guidance. Yours sincerely Stafford vision Manager Hccith iS Environment Protection \i j ^ f i \, j cc Dr T R Torkelson, Dow Mr R N .`heeler, UCC Mr M J S Gibbons, ICI Americcs URL 16210 o I/ * Air Products and Chemicals, Inc. Box 53$. Allentown, PA 18105 (215)398-4911 19 July 1979 Hr. jftn Stafford Di v ion Manager Impeial Chemical.Industries it ft Box No. 6 fcuau Road ftHqai Garden City ttrtfenUhlre A17 1HD Ittr John: I just returned from vacation to find your letter of 19 June on my (lest. For the past three weeks, I have played with my grandson and gone baalihg in Lake Michigan and now you bring me back to dead mice. I rise find that Ted has responded to your letter telling you of some of tie actions which the CMA Is taking. I am very happy that hers acting tee, because several weeks ago it was agreed that as between the A1HC art 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 pHIc. Tie matter which seems to me to have received inadequate attention is the cartrast between the published conclusions of the author on page 19 and the press release which was prepared by the CPSC. The former said that ms cancer was caused by this experiment and the latter said that there mbs. 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 iunaterfal 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 la 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. URL 16211 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, 1 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: Dr. T. R. Torkelson, Dowv^ Mr. R. N. Wheeler, UCC Mr. M. J. S. Gibbons, ICI Americas Mr. J. Lawrence URL 16212