Document 9J5YoEnwE2dbDjyOY6gMYML1p

ACC S 1979 I. a. lovetts renca Dr. W. D. Harris - Uniroyal Inc. Dr. M. N. Johnson - B. F. Goodrich P3*/ "^*5 /^jS^wT" Dr. C. D. Kary - Shell Chemical Mr. J. T. Seawell - CMA Dr. W. M, Smith - Air Products & Chemicals Mr. R. N. Wheeler - Union Carbide . j. Pl&^l cc: J. T. Barr - Air Products & Chemicals -srr^ T)i "5 j-i P. J. Gehring - Dow USA J. Lawrence - SPI R^C3` '.-nt - ' j ?rro*-->. ~^ C. Maltoni, M.D. - U. of Bologna RESEARCH, J. M. Norris - Dow USA J. Stafford - ICI, England P. G. Watanabe - Dow, USA i\UG l y \V. M. SMITH ) Xs ~Td PREPUBLICATION DRAFT OF CPSC/EDGEWOOD ARSENAL REPORT M. 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. .5o cui;;/ To 5pr 7 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. 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 OF THE DOW CHEMICAL COMPANY ddC UO1 P1 7*.'ect:~r,e VVe.'wyn Garden 23. (STD Code 07073) Tesex 26-251 Dr J T 3arr Air Products 5 Chemicals Inc Go.x 533 Allentown Pa 18105 USA Industries Limited Plastics Division Your ref. Our ref Tel ext Date JS/mJc/DSO-1 07 3162 ` 19 June 1979 Dear John VCN - 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 navs had professional views expressed on the report and you can guess their tenor from the following:- " (1 ) The findings which the author claims are important are:- (a) IC.3 mouse, single dose: Pulmonary adenomas Carcinomas 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 10% 10.1% 12.9% 16.8% 32.355 0% 0% 0.7% 0.7% 2.2% Control Ten times at 500 ppm (c) A/j ncuse 34. 7A.7% 3.3"5 13.3?S Control ICO times 50 ppm 34.5% 41.155 2.4/5 4.4/5 I have not formally carri sd cut a statistical analysis I feel sure that only the- 5C,000 ppm x 1 hour dose is significantly different f rom the controls. (3) Nice often have a high inc Ldence of pulmonary adenomas.. The diagnosis of these las ions is, to say the least, inexact, Teforo giving cny credanco to the findings, I believe we should Sieve an independent pathologist's opinion on the lesiens. GGC 001316 % (4) Pncumc.oit 13 was dicgnosed in the single-dose exposure. It seems highly unlikely to me that it can have been the result of exposure to VCh 13 (or 13) months previously. ChemicallyiuduceJ lesions would hove resolved by that time or have presented os chronic, healed lesions. It suggests to me that the mice wore 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 E Steiner and C G Loosli (The effect of human influenza virus (Type Aj on the incidence of lung tumours in mice. Cancer Res ^0 3S5 1950y includes in its summary the following statement: "The infection produced great, tumourlike 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 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 a single figure index of exposure seems very strongs end I am not prepared to accept the conclusions based.on it. You will no doubt realise from the above comments thet, in my opinion, the study does not provide conclusive evidence that VCM produced lung tumours in mice. The factors influencing the incidence of these tumours in mice ere imperfectly understood, and even if the pathological diagnoses were confirmed and 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 hc-aitii, bearing in mind the human epidemiological evidence and the inconclusive nature of the experimental evidence. " I have discussed these comments with cur professionals at the Central Toxicology Laboratory ana they hove asked me to get in touch with you to find out what the American industry is doing about this report, either vio tr.e oPI or the h^A. Is the US PVu. industry going to ignore the report? Are you going to publish any comment; Have you decided; fcr~^xa'mple7~to" get in touch with the researchers to discuss the significance and also to look at the path slides along with the Edgewood Arsenal pathologist. I would atsful if you would let ms knov; what action, if any, you 0 3 i r. :c take. One of the thoughts that wes in our minds was that c:: c: cidec! to do nothing we might wish to have one of our ^ - W A. C tv-- rep cr consulting pathologists visit Edgewood Arsenal to discuss T m < . o -l <* f i nn Sal t ,,n. i vo fro-, th_- . ire.ct Acsociatian was La<e sere bsGti fide ICI to ask for views and the first reaction I got " siiw could anyone Jo suen work", and the second comment of cur British Ioij stricl and Giologiccl Research as an exercise in fc tuity it (the CPSC report) would 3uck comments cr all very well but cddly enough GGC 001817 ue tiro cutting soma 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 are a number of studies with nitrosamines and afiatoxins which demonstrate this effect. Has the US press continued ta 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 Torkolson/ Dow Mr R M Wheeler, UCC Mr M J S Cibbcns, ICI Americas ggc oc t Mr. John Stafford Division Manager Imperial Chemical Industries P. 0. Box Mo. 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 was. 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. GGf 00lSis 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. JT8:cmk cc: Dr. T. R. Torkelson, Dow^ Mr. R. N. Wheeler, UCC Mr. M. J. S. Gibbons, ICI Americas Mr. J. Lawrence GGC 001820