Document p29dvMgKYrzLMaJnZv2N5bMRX

14:41 ,' 12/Bl/97 11:23:12 Via Fdx -> Z16 58& 8314 D. STROTHER Page HIU VIA FAX TO: STROTHER, DALE E. BP AMERICA FROM: ATTN: DALE STROTHER TO: FAX PHONE#: ~16-586-8314 Job Number: 06168939-008-27-0904 TIME: ~n Dec 01 14: 22: 33 1997 8 pages inc1uding cover sheet BP-00010714 14:41 . 12/Hl/97 14 :23 :ZB via. Fax American ) Petroleum Institute -) Z16 586-8314 D. STROTHER Page HHZ 1220 L Stree~ Nor1hwesr Walihinglorl, DC 200Q5.4070 Tel202 682-8341 Fax 202 682-$270 e-mail mongilloOAP!.org DaVid A. Mangino Manager, Health Sciences Dec.1, 1997 TO: Ben%ene_Task Force FROM: David Mongillo RE: December 12th meeting In Preparation of the December 12th meeting please review the following documents; E-mail message detailing a conversation wih Dan Byrd-- asking for API to pfovide support in his legal negotiations with EPA about release of data. E-mail message from R. Schnatter summmarizing the recent meeting in Berlin discussing the draft benzene risk asssessment. If you cannot attend the meeting and Wish to be connected by phone. please contact Vanessa at API (20.2) 682-8330. Thanks An aqual oppoi!Unily employer BP-00010715 12/01/97 14!42 12/Bl/97 11:21:27 Via Fax -> 2lo 58~ B314 D. STROTHER mechanistiC evidence around benzene leukemogenesis (as well as the data for other compounds-consid!'red such as butadiene, topoisomerase inhibitors and radiation). The existence of the report was announced with little fanfare when it was released in September (I believe) and not discussed (as I remember) at the July public meeting. According to Dan (I have not had time to go back and check), many of the positions espoused by EPA to dismiss the use of mechanistic data to aher the current potency factor are taken almost whole cloth from 1he Eastmond report. Dan feels that it was a conflict of interest to have the author of what was, in essence, a support document be a reviewer for the parent document. David and Gerry, I understnd that Dan has spoken-with both of you. How does this fit with your conversations? Patrick From: Carol Henry To: 'gerhard raabe'; David Mongillo; 'pat beatty' Subject: Benzene Date: Thursday, November 13, 199712:08PM While I was attending the CMAICIIT State-of-the-Sciettce meetings, Chris Money, Industrial Hygiene AdvisoN:urope. Exxon Chemical, (01703-896175189661 o fax) talked with me about benzene actiVities. He is organizing a ses5ion on benzene for the Tax Forum in April in Brussels. The goal of the workshop Is to discuss the role or value of threshold mediated cancer mechanisms. Two papers have been or will be commissioned: an academic. scientific state of the science and then.a "popular" science piece. He would like to lalk with us about the meeting and whclher there are some common Issues for both the European group and our Benzene Task Force. I told him that if there were no objections from API. a copy of the recently submitted comments on EPA's risk assessment document could be sent to him. Are there any problems sending him a copy? Comments on next steps? Page OHi Page-2 BP-00010716 14:41 l2/B1/97 14:23:58 Vid Fax -> Zlo 586 8314 D. STROTHER .....~ David Mongillo From: Sent: To: Subject: Carol Henry Friday, November 14. 1997 11:35 AM David Mongillo FW: Benzene For FWD to Benzene Task Force From: Sent: To: Subject: BEATTY. PATRICK W. -PWBE(SMTP:PWBE@ehGIItoncoml Tht.I"Sdoy. Nov91T1ber 13. 1997 8:29PM Carol Henry RE: Bc;)nzene As we discussed this afternoon, I don't see a problem with sharing the comments. They are, atter all, a public document now. Also as you requested I am providing a short description of my telephone conversation with Dan Bird (Byrd?}. The information I am relaying is as told to me by Dan. I have no Idea as to its veracity. I spoke to Dan on the 5th or 6th of November. He has filed a FACA lawsuit against EPA requesting a copy of the comments of the External Review Committee (eRC) members to EPA that were the basis of the discussions held by the ERC on July 16th in the pubrtc meeting. As I remember, he requested at the end of that meeting that the comments be made public and when told that 1hoy would not, mentioned a lawsuit. Currently, EPA has offered to settle with him by gMng him a copy of the comments on the condition that he not reveal them to any other party. He will nJfuse that offer and will demand that they be made public and that the-review be taken to the SAB where he believes that it should have been all along. He wants API or an oil company to send him a letter stating that they want aocess to these documents, and that if they had access during the public comment period, they might have had different comments-and that access now might lead to amended comments. He says that he needs to demonstrate to the judge that others are interested in the documents. EPA has filed for dismissal and his lawyer has filed for summary judgement. He ber~aves that API and the industry would probably want '-7 \ j~SAB review. (Do weeki er).- we?) Dan would like a Jetter in support b~eald:of 1....\ \ \11'1 :-1 r He tok:l me that he believes that the Office of Mobile Sources has orchestratad the whole thing and was intrumental in having reView by a lower level committee rather than the SAB because-they want the benzene potency factor to stay where it is so as to justify their health assessment of automotive exhaust. - - He also objects to the Inclusion of Oavld-Eastmond on the -ERC as a conflid ot interest. DaVid wrote under eontrad to EPA a-large document on chemical and radiation induced leukemogenesis which was billed in the title as an assessment of the validity of animal models for assessing risk. The document was very much a discussiOn of the Page 1 Page EUJ3 BP-00010717 14:43 iZ/81/97 1~24:58 Via Fax -> 21G 586 8314 D. STROTHER Page BBS David Monsmo b 11 From: Sent: To: Ce: Subject: Robert.Schnatter@ ERE-EXXON .sprint.oom[SMTP:Rober1.Schnatter@ ERE.EXXON .sprint.com] Tuesday, November 25, 1997 9:36AM FPEXMAIL-MONGILLO : FPEXMAIL-PWBECHEV *: FPEXMAIL-GERHARDK *; EASTMILLMGBIRD MGBIRD; EASTMILL-TWARMST 1WARMST; EASTMILL-SJWYKOF "SJWYKOF; EASTM!LL-DAEDWAR oAEDWAR; EASTMILL-JHSMITH "JHSMITH; EASTMILLRDPHILL "RDPHILL: EASTMILL-SELERMA *SELERMA: EASTMILL-AMGOLDS *AMGOLOS EASTMill-MJNICOL *MJNICOL; EASTMILL-RJLEWIS *RJLEWIS; EASTMILL-WWHUEBN *WWHUEBN NOTE 11125/97 03:37:00 --------------------- Forwarded with Changes ------------------From: Christopher O..KRAAINEM MGt':ey at SOFTSWPO Priority: Urgent Date: 11/25197 3:37AM To: ARSCHNA at EASTMILL To: MGBIRD at EASTMILL 'To: FPEXMAIL.TBADGOCK at SOFTSWPO 'To: FPEXMAILBARRYSIM at SOFTSWPO Subject: NOTE 11125197 03:37:00 Here is a summary oTtne recent meeting held in Bertin (11/18) to discuss the draft risk assessment on benzene prepared by the German regulatory agency (BGW}. The present document will be combined with sections on occupational exposure and general population exposure being conducted by other German regulatory agencies. The integrated document will then serve as the basis for the EU benzene risk assessment. at which time it will be formally reviewed. by other merrber states. During the Bertin meeting, the Germans were hoping for the integrated German document to be finalized and ready for fomral review sometime in mid to ia1e 1998. Rob Schnatter ~~~~==~~~~~~~--FoRNaruHeader _____________________________ Subject: NOTE 11/25197 03:37:00 Author: Christopher D ..KRMINEM Money at SOFTSWPO Date; 11/25197 3:37AM Tel: 44.170:3.896175-\\ Fa)(: 44:1703.896610 Terry/Bany rn-ese now incorporate the comments form those who attended. Could you plse arrange to circulate the notes within APA and CONCAWEIEUROPIA. I have copied them to Schnatter & Bird. APAICONCAWEIEUROPIA JOINT BENZENE STEERING GROUP NOTES ON A MEETING AT THE BGW, BERLIN, 18th NOVEMBER,1g97 PURPOSE Page 1 BP-00010718 iziBl/97 14-:25:31 Vi Px -> 216 586 8314 D. STROTHER To provide comments to the BGW and reinforce relationships as part of the informal process for reviewing the health effects aection of the draft German Benzene Risk Assessments. SUMMARY The meeting was very constructive. Clearly considerable thought and effort has already been expended by the BGW in putting together their considered thoughts. The BGW scientists (with the possble exception of the epidemiOlogist from the Free University of Berlin)_ all showed a sound knowledge of their disciplines and contnbuted to a wide ranging, open and positive discussion. Prof. Gundert-Aemy (the Director of BGW Dept 8) and Prof. Hertel (the Asst. Director), helped ensure the discussions remained open and friendly. The BGVV are clearly empathetic towards mUCh of what the RC states and are supportive of industry's argumen1s where sound science exiSts_ The mismatches in their RA exist where theyJ:~elieve gaps remain in the science. This--'.s compounded by the Technical Guidance Document's (TGD) "require.-nent" to adopt a precautionary approach to the Risk ASSeSSment for genotoxic carci1109ens. MEETING HIGHLIGHTS 1. The amount of disagreement between the EBSI RC and the draft RA was recognised as limited_ Many of the poin1s contained within industry's initial response to the draft RA were accepted (and particularly, the need to view ANLL as the critical effect; the requirement for a consistent critique of stUdies within the epidemiological section; the absence of a discussion or. mechanisms: and the NOAEL of 1Oppm for blood effects)_ Our critical yet positive stance was valued by the BGW_ 2. There was consensus that ANLL ShOUld be seen as the critical effect. The epidemiology section Will be reviewed in the context of the assertions it currently contains linkillfl benzene exposure to other haematologic neoplasms and related disorders (and see #3 below)_ 3. The limitations of the 1997 Hayes study were recognised. The 8GW stated they were CQnstrained in their criticism by the lack of publiShed information critqulng Hayes. In the absence of any nletter to the editor" the SG Wilfforward a note outlining our wmconcerns. It be referenced within the RA and made available to other Member states at the time of the formal consultatiOn -within the EU_ The BGW encouraged the SG to produce such a "letter to an Editor", however 4. The BGW stated mUCh information was omitted because they were not yet FORMALLY aware of it, ie.it has noibeen provided to them by industry. A preferred process was agreed which will address this shOrtcoming in futum; KEY articles (defined as published articles. reports with supps.1ing data, or relevant exposure data which will be treated in confidence if it relates to individual scenariosa) will be provided together with all aocompanying note from the SG containing our considered View of the Significance of the findings The BGW do not wish to receive abstracts, or articles which are merely speculative in terms.of hypotheses, etc. Although copies of all-the refs cited in the SGs comments on the draft RA were suppfred to the BGW at the meeting and Will be Page 2 Page BH6 BP-00010719 14:44 12/Bl/97 14~o:ll Via Fax -} Zlo 586 B31i D. STROTHER acknowledged, they were not accompanied by such a supporting note_ The BGW welcomed the APA's initiative to update the Hedset via BIBRA; within the SG there is an ongoing need to flag key new data with comments to the BGW and ensure the narrative within the APA Hedset is compr.mentary to the RC and RA ACTION : AIVT Badcock 5. There appears to btJ some disagreemenl within BGW concerning the degree of "prooF required to demonstrate the existence of a threshold. The toxiCologists believe the current mechanistic evidence is insuffiCient and that further data (not defined) are necessary. However, many of the papers supplied a1 the mtg (see #4) contain data not included in the BGW draft and Gunctert-Remy will incorporate these mechanistiC considerations into her review of benzenes phramacokinetics. Gundert-Remy {and others?) believe human evidence is key, that a firm mechanistic basis is not a prerequisite if sound human data are available, and that recent studies (the NCI apart) help demonstrate such a value_ One suggestion which emerged (from Hertel) was fer-the SGJ.o identify key evidence which it believed would be helpful in demonstrating a threshold at mechanistic level and for this to be included in the RA's conclusions that this would then allow a more categorical statement to be included within the RA at the t::U leveL This areas needs to be debated more fully within the SG and elsewhere. ACTION: All Gundert-Remy made the comment that the TGD is cuJTently biased to toxicological data and it would be helpful during a future revision, to include a section addressing the role of human data in the RA process. The SG should explore whether we ought to be proactive in this respect, eg. is there-a-role tor CONCA.WE. ECETOC or some other organisation (via AI~C ahd US links?}'? ACTION ; W TordoiriAII 6. There was diScUSSion on the-extent to which benzene containing consumer products were on sale in Europe_ The BGW appear to have accessed information sources outside those available to the SG, eg. customs data. For example, the suggestion that benzene containing paints wem imported into Portugal from China for consumer use was raised. The BGW was sympathetic to our assertion that within Europe no such consumer products are manufactured and that the Marketing &Use requirements prevail. We need to establiSh through the relevant CEFIC sector gro.ups that these comments are valid and to obtain l&tt9rs from them confirming these vieWs. This area is a clear weakness in terms of the extent to which the RC represents a full picture of Benzene exposures in Europe. ACTION: T Badcoci</C Money 7. ~ertel and Gundert-Remy did nol consider a European Toxicology Forum meeting on benzene would create 'problems' tor the BGW. They perceived it as being be helpfulin developing consensus on benzene views. Specifically, a discussion on Hayes would be beneficial_ Page3 P-age HEI7 BP-00010720 14:44 i2iB1/97 14!26!49 Via Fax -> 216 586 B314 D. STROTHER Page BEI8 8. A further meeting with the BGW is unlikely. However, informal contacts will continue. Hertel indicated similar meetings are likely to be ananged at the informal stage with the UBA for the environmental section and the BAU for the occupational exposures section. These are anticipated in 02/98. The final consolidated RA is unlikely before end-98. 192CDM Regards Chris Money IH Advisor - Europe Pago4 TOTAL P.08 BP-00010721