Document 44q3Rvzv590p7q4EOvwd50jma

IMPERIAL CHEMICAL EJDOSTRIHS LD'IITSD MDiTD D17131011 DIVI3I01T DEDICAL D3PARTK3HT highly confidential 7Hm CZL0HID3 TOXICITY M33THrc3 HELD AT MCA HEAD QUARTERS, WA iHEIDTCI.' DC AND NATIONAL ETSTITUTE 0? OCCUPATIONAL 3AF3TY ADD HEALTH. R0CE7ILLE, MARYLAND ON I6TH AND I7TH JULY 1973 Circulation ; - AUTHOR : DATS s D P DU??I3LD 20 JUL 73 Dr P J P ^.oVu-rts Mr D 3 Paterson Dr K P './hitahead Mr D M Slliott Mr A 'f Barnes Dr J Gadsby Mr 0 J Sleddon Dr D Vinter Dr A A B 3van/Dr D K Conning/Dr K 3 Villiamson /Dr R S Davies, ICI Auatralia Limited J Dr i C ? Adams fir C ? (Uhivero Filo 000001 HXGHLf COSl'lDr&TIAI. MEETIZIC5 HELD AT KOI HEADQUAR.T2H3, WASHINGTON DC AND HaTICMAL EiSTITUTJ 07 OCCUP.vrlOBAl SATETr AES HEALTH, ROC3C7ILLE, OH 16TH ASS 17TH JTJ1T 1975 HTPHosucixas At tAe meeting of the Saropesjp Group in Brussels on 15th June 1975, It was agreed that KCA would be given permission to reveal to HI03S data arising' from the Bologna study-, This agreement was communicated to the MCA Group which attended the Brussels meeting* KCA were told that Drs Garlands, of Montedison and Duffield of ICI would attend the ETI03H meeting. MCA were requested to allow time for the European Group to approach their respective Goreramenta before the HI03H presentation end far title reason the HIQSH meeting was arranged for July 17th. Soring the week of 9th July. Montedison requested an urgent meeting Of the doctors representing the European Group and this took place in Bologna on 12th July. At that meeting. Montedison stated that they were strongly against giving HI03H any results of European work, as some of the Group bed not yet approached their own Governments end as HIOSH might take precipitate motion on the basis of data given to them* Montedison also stated that Sr Garlnnda would not be attending the HIOSH presentation. The Soiv&y and Hhone-Progil doctors felt that, as these statements were a change in attitude, they would have to consult their Ifcaageasits, in order to clarify Duffield's resit at me HIOSH meeting, am a result. Bernard! of Shone Progil and Qoaselin of Solvay were contacted by ICIThey felt that Duffield should exercise "on such discretion as possible" when presenting European information. MEETING AT KCA HEADQUARTERS - 16th JULT 1975 Present ; G 3 Best A Clark B Barra.ckB.in 7 K Rowe. s N Wheeler W E Rinehart D P Duffield MCA bow CheaLcal Uhion C .rbido Bthyl Corporation ICI Before the meeting, Duffield took the opportunity of Speaking to G 3 Beat and outlined hie developments which had occurred since the Brussels meeting. Duffield said that at the HI03H meeting, he planned to give an outline of the protocol of the Bologna work and the fact that tumours had occurred in tha test animals. After that, any questions posed by NI05H would be answered frankly. Best s tated that HCA vruulA be happy to accept that fore of presentation. This position was reiterated at the full meeting, which was held in order to go through the presentation. The only item of any note at this meeting was that it had been planned to give iviOSH a version of the results of Viola's work which was given to MCA orally by, it is thought, befevre. These results included approximate numbers of ceruminous gland tumours arising at levels owe than 30,000 ppm. Bo published data of this 3ort baa over appeared an ** TOTAL HHLE.03 ** icv 000002 -2 Duffield said that the information could well ho inaccurate. This was agreed and it was, therefore, deleted from the presentation. MEETING AT NI03H HEADQUARTER, ROCKVILLE, MARYLAND - 17TE JULY 1973 . # Present : Dr Marcus Key - Director Dr Donald Lassiter - Toxicologist Hr Richard Janes Dr Keith Jacobsen - Toxieologiot/Biocheaiat , Dr Prank Mitchell - priorities Analyst ) HIOSH G E Best V E Rove R 11 Wheeler W E Rinehart MCA representatives D p Duffield European Group representative tf Rove acted as spokesman for the MCA Group. He opened by saying that the meeting was requested by MCA in order to inform MI03H of the carcinogenic potential of VCK in rats and to outline the MCA programs for further investigating this effect and the evaluation of any hazard to man. He indicated the size of the Industry in the 03A and abroad and then went on to speak about the published Viola work and the work on AOL. The changes in the TLV for VCM, due to the finding of minor liver effects hy Dow some years ago were also mentioned at this stage and then Duffield was asked to speak. Duffield opened by saying that, a) not all European members had yet had an opportunity to approach their Governments. b) the European investigation was not yet complete. c) the European work would be published in late 1971. The Viola work was then outlined and the criticisns of it, on the basis of . 1 Experimental conditions 2 Doubtful strain of rat used 3 The high acute mortality 4 The very high exposure levels, and 5 The histological interpretation of the tumours. In spite of this, the European Group had felt it necessary to investigate the matter further in throe areas i) Ri3k to Man. At thin point the Hillhou3e epidemiology was outlined, as were the methods used in the study. It was emphasized that the exposure lev Is in tha past were higher than those appertaining at present, as measures to reduce exposure had been and will continue to be used. icy 000003 3 ii) iii) Animal Work. The guropean croup had considered that an independent investigator should he used and that the work was being done in Italy. A range of exposure levels was being used together with a control group and a vinyl acetate group. The atrain of rat was the Sprague-Dawley, known to have a low natural tumour incidence. The work had been started in 1971. Follow up work, involving a repeat of the 30,000 ppm and short term exposures was at present being undertaken. Oral carcinogenicity tests were being planned at present, although technical difficulties wero poeoibie in this work. As it was known that MCA were also concerned with this problem, the European results were passed to them In order to assist in determining the form of future investigations. Finally, it was emphasized that on the basis of the limited epidemiological data available at present, there was no Indication of employees having suffered any ill affect as a result of working in contact with VCH. Howe then explained the protocols for the work to be done by Industrial Biotsst and Tabershaw Cooper and left these protocols with HIOSH, together with the press releases by MCA; announcing that the work has been contracted. After the presentation HIOSH asked a number of queationa:- 1 Duffield waa asked again when tee work in Italy had been started, the answer baing 1971* 2 He ws3 asked the lowest level at which tumours had occurred and the answer given was that the lowest effect level was 230 ppm. 3 Again in response to a question, Duffield stated that tumours had occurred in multiple sites, brut these sites were not specified. 4 MCA was asked if any metabolic studies were planned. They said that this was being considered. Rowe revealed that Dow are doing independent work which indicated that VCH reacted with cysteine and glutathione, although the significance of this with regard to the carcinogenic activity of 7CH was not apparent. 5 Rowe was asked if, with regard to the epidemiological data, it was possible to estimate, although apr,rorimately, the exposure levels on VCH and PVC plants, retrospectively. Rowe said that this was possible. 6 MCA were asked whether they would be agreeable to H 3toknger (a member of the ACCIH Committee and also HIOSH) seeing the protocols for the future MCA investigation. Th3 was agreed to, 7 The question of sales of aerosols using VCM as propellant waa raised by HIOSH. MCA replied that only one or two US companies still sold VCM for thi3 purpose and that it wa3 expected that by the end of this year, all sales for this purpose would bo discontinued. 000004 4 8 HIOSH asked whether interim reporta on the MCA investigation could be given to than. This was agreed* Dr Key said that he was very pleased that HIOSH had been approached by industry and wished that this was done more often. He stated that it would a030 the Government 'e task in setting standards for industrial hygiene in industry. APPRECIATION 0? MEETING The response of NIOSH appeared to be good and there was no indication that they would take precipitate action. It la clear that HIOSH is unhappy with the "blunderbuss" type of legislation being Introduced to apply severe restrictions to the use of materials which* although rodent carcinogens, have never been shown to be human carcinogens. There was no indication* although of course it is impossible to be sure* that NIOSH will take any action to impose tighter legislative control on exposure to 7CK, until there is more indication from further MCA work as to whether or not a hazard to exists* It was surprising to both MCA and Duffield that there was not a protracted discussion of European work* It was not until after the meeting that Rinehart of Ethyl told the other MCA representatives and Nuffield that Jacobsen* one of me members of NIOSH present at the meeting, bad worked at Ethyl until recently and was aware of the results of the European work. It was known before the meeting that Jacobsen would be attending and the reason for Rinehart not telling the other industry representatives of this fact Is extraordinary. This may account for .the lack of discussion. NOTE : MCA once again asked that a meeting between Maltoni and the Industrial Biotest experimenters should be arranged* Duffield undertook to pass this request to the European Group, D P DDPPIELD DPD/MT VC\ 000005