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OSHA HEARING REPORT DATE: PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE September 19, 1994

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OSHA HEARING REPORT DATE: PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE September 19, 1994 REPORTER: ALLEN R. PURVI~I: SHOOK, HARDY & BACO~..~i At i0:00 a.m., September 20, 1994, a U.S. Ad, ministrativ~i Law Judge will convene what will likely be the lengthlest and mos~i~j significant hearing on a proposed workplace rule in the history the .Occupational Safety & Health Administration (OSHA). Thei!~i purpose of the hearing is to gather information and opinions ab ut~,~.:~ the agency's proposed standard on indoor air quality (IAQ) ~: including its proposal relating to environmental tobacco smoke'~,,~ (ETS) . This initial hearing report will provide backgroun~ information and will describe the format and procedures of hearing. ~.-.~ Background of ProPosed Rule ~" The history of the proposed rule dates back to May, 1987, when three public interest groups petitioned OSt~ for a Emergency~. Temporary Standard to prohibit smoking in most indoor workplaces.~.~.~ At that time OSI~ determined that available data with respect to'~ exposures were insufficient to demonstrate the existence of "grave danger," and refused to enact temporary standards. In ASH filed a lawsuit challenging OSHA's denial of its petition a Emergency Temporary Standard, but this petition was denied by a ,. federal judge _on the basis that OSHA had reasonably determined it could not sufficiently quantify the workplace risk associated with~ tobacco smoke to justify issuing an emergency standard. In September 1991, OSHA issued a Request for Information~<.~ (RFI) on indoor air quality which generated over twelve hundred,~ comments by interested persons, groups, unions and industries.' Claiming that the majority of comments favored OSHA's regulation of~ indoor air quality, on April 5, 1994 the agency published the proposed rule that is the subject of this hearing. The proposed rule (which can be found in the Federal,~ Register, Volume 59, No. 65, page 15968) consists of two main sets:?~ of provisions -- those dealing with general indoor air quality:!i 51268 ~39
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issues and those dealing with environmental tobacco smoke. I~! smoking is to be permitted, the proposed rule would requlre-~i designated smoking areas which are to be separate, enclosed rooms~ exhausted directly to the outside. In accordance with its usual procedure, OSHA solicite~ written comments which were filed with the agency by August 13..~i Persons wishing to appear and testify at the hearing had unti~i August 5 to file their Notice of Intent to Appear, and theif~ written testimony had to be submitted to the agency by August 13 As of this date, 109,000 separate written comments hav~ been received and docketed by OSHA and the agency acknowledges tha~[~i there are tens of thousands of additional comments which have bee~ received but which have not yet been docketed. Some observers~i estimate that the final total may exceed two hundred thousan~i separate written comments. Experts in the area advise that th~i previous record for written comments was approximately 3000, which~ were received in response to the agency's proposed blood-borne~0~ pathogen standard. Seven hundred and ninety-four individuals hav~ filed Notices of Intent to Appear, a number which is also believed~ to be a record. Individuals representing labor unions, restauran<~ associations, health organizations, as well as the tobacco~ industry, have indicated their intention to appear before the~ Administrative Law Judge and the OSHA panel. In response to th~sz overwhelming interest, OSHA has recently extended the hearin~ through the week of December 5, 1994 • ~earing F~rmat and Procedure~ The hearing will begin at 10:00 on September 20 with statement of the proposed rule by an OSHA official. The first two~ days of the hearing will be held in the Andrew W. Melon Auditoriu~ on Constitution Avenue in Washington, D.C. The remainder of week's sessions will be held at the Department of the Interior~. Auditorium. The location of subsequent sessions will be announcedi~ daily. The auditoriums are being used to accommodate th~! unprecedented number of potential witnesses and observers. Administrative Law Judge John Vitone will preside at th~ hearing. However, various OSHA officials will also sit on the~ panel with Judge Vitone and will participate in questionin~ witnesses. The following OSHA individuals are currently expecte~i to be on the panel. Sue Sherman, OSHA Attorney John Martonik, Acting Director of Health Standards Debra James, ETS Project Officer Sheldon Weiner, Office of Health Standards
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It is also anticipated that a representative of OSHA's pollcy~i office and the regulatory analysis office will be members of panel In stark contrast to a lawsuit, this hearing has th~ stated purpose of information gathering and clarification. It an informal administrative proceeding rather than an adversaria~i lawsuit. Therefore, standard rules of evidence will not apply an~i information will be received into the record regardless of relevance or foundation. The ultimate goal of the hearing is to:~ gather information to enable OSHA to formulate a final version the rule if they deem that to be appropriate in light of the~i evidence and comments received at the hearing. After OSHA's opening statement and explanation of th~i rule, the OSHA representative will be subject to questioning by any~i individual who has properly filed a notice of intent to appear.~~i Technically, each of the 794 individuals could take up to ted~ minutes to ask questions of OSHA's initial representative, the OSHA panel, and any witness who appears at the hearing. It is the~ function of the Administrative Law Judge to prevent redundancy!! while permitting legitimate questioning of each witness whG[b appears. Individuals asking questions may not use that opportunit~ to present their own testimony, thereby eliminating classic "cross-~ examination." Extensive questioning of any witness has th6 potential for delaying or extending the hearing beyond it~ scheduled completion date of December 5. At the conclusion of the hearing, the record will remai~ open for 60 days to receive additional data and information. A 30~.~ day period will follow during which interested parties may file~ post-hearing briefs in support of their respective positions on the~ proposed rule. No reply briefs will be permitted under OS~ procedures. OSHA is expected to issue a revised rule in 1995 based o~ the information produced during the hearing ~process. Th~ publishing of the revised rule begins anew the comment/hearin~ process described above. When and if a final rule is adopted by~ OSHA (experts predict it could take as long as eight to ten years) a challenge to the rule in federal court is likely by one or mor~ parties who are dissatisfied with the rule. Every rule propose~2 and adopted by OSHA has been challenged in court. ~gbacco Zndustry ~nv~!vemen~ Philip Morris, R.J. Reynolds and the Tobacco Instltut~ will actively participate in the hearings both in ~erms o~ presenting testimony and questioning witnesses. Representatives o~
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Philip Morris are tentatively scheduled to testify on Friday,0~ ~ September 30, with repre@entatives of R.J. Reynolds tentatively~i scheduled to testify on Thursday, October 6, and Friday, October All witnesses have prepared and filed their testimony with agency, and their oral testimony will follow the prepared!~I testimony. In addition to the tobacco industry, the Building Owners.~! and Managers Association (BOMA) has taken an active role in<!~ opposing the proposed regulation although their opposition is not~i based on the ETS provisions. Media Attentio~ The conduct of this hearing is expected to generate constant level of national media attention. Sunday's Wash Post carried a major story describing the hearing, and the New Times has also assigned a reporter to the hearing. This morning OSHA, the Coalition on Smoking or Health,;~i and Philip Morris held a series of press conferences for the media..~ Philip Morris' press conference was well-attended with nine\ television cameras in place. Brennan Dawson of the Tobacco~ Institute; Dr. Richard Carchman of Philip Morris; and Patrick;~ Tyson, an attorney and former Acting Administrator of OSHA,~ represented Philip Morris. Tyson explained that in his opinion~ OSHA has exceeded its authority because the U.S. Supreme Court has~ determined that OSHA can only regulate a siunificant r~$k -- not ~ ban a product to prevent ~ exposure He explained that in the~ past OSHA has determined "permissible exposure limits" for various~ toxic substances but the current proposal would violate OSHA'_~ authority by establishing a "zero exposure level" for environmental~ tobacco smoke. Dr. Carchman pointed out the numerous weaknesses in>~ the scientific basis for OSKA's proposed rule, while Ms. Dawsork~2~ emphasized the ability of employers to resolve any workplace ETS.. problems without resorting to additional federal regulation. Sghedule for September 20 ....~ After OSHA's opening statement and explanation of rule, Dr. Phillip Morey is the first witness scheduled to testify~ on the agency's behalf. The remainder of the week will feature~..\"~ testimony from physicians and anti-smoking activists such as~ Stanton Glantz. 51268 23@}2
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PRIVILEGED ArID CONFIDENTIAL ATTORt~Y /CLIENT PRIVILEGE DATE September 20, 1994 REPORTER: ALLEN R. PURVIS SHOOK, HARDY & BACON OSRA's administrative hoa~ing began on schedule this morning but that was the last thing that occurred on schedule ~"~ today. Despite sxtend£r19 the 0ession into the evenln9 hours, ,3udge Vitone still has not been able to compl~te the first item on the .~ agenda -- the questionin~ of the O$~A panel by interests4 parties- - and that exercise will resume t0moErow morning. Zn light of the length o~ today's session, the number of questioners and the variety of topics covered, this re~ort will be limited to the highlight~ of today's session. Upon entering the Melon Auditorium, one ie presented Two lon~ table meeting in a V are on the reck, carpeted stage. 3udge Vi~one's e~ller table sits a~ the end oE the V, and the OS~A panel members sit behind the table on the riuht. The table on the left is reserved for witnesses. Judge VEtons, who wears a business suit rather than a black, judicial rob~, opened the proceedin~e with brief remarks. He des=Eibed his ~ob as ensurin~ that a ~air ~earing o£ .veryone's views would occur, and he briefly discussed some of this informal he~rin~'s guidelines. The ~udge ~hen turned the hearing over to John MarConik and Michael Sxlverstein ~Director of Policy for OS~A), who p~ooeeded ta introduce the other OSHA panel members. These members included Debts James, who is an epide~iologist and the pro~ect sirius= for this regulation. Other pane~ members included a toxic~Iog£st, a vent£1.tion engineer, = mechanical engineer. Dr. Ja~es Repace, a physicist "on dstaal to OSHA from ~he EPA," was also intr~uced. Susan She~an and Susan Kaplin, £r~ the Off~=e of the Solic£%or, ~pl.~ea the panel. The vast 51268 2343 a surrealistic sight. This ornate hall has massive columns down each side and across the front. A small indented alcove at the end of the room, and the judge and OSHA panel members were ~war~e~ in the ~i££~-£oot-coilit~ roe=. ceilings ~d "#~is ~e inlaid with grid trim and massive chandeliers han~ fr~ the ceilin~ and the atmosphere zs further enhanced by four spotlights used to ill~n~t~ th~ ,~age ~hile the re~ai,~er auditori~ remain, in various degrees of
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and 5~s wi~h f~equen~ and s~e~imes frantic con~'~nces wi~h cem~nder of the ~ne~ meters. ~.~ Mar~onik b.gan by reading a ~repare~ statement, which~ heavily emphasized the prel~in~ nature of t.h~. propo.ed rul~ the statement e~lained OS~'s regulatory mandate, a review proposal's develo~ental hisser>, OS~'s ~ro.p,ctive of IAQ as health issue appropriate ~or regulatezy action, and OS~'s worke:s. ~on~k stated that it was OS~'s prel~na~ view IAQ causes a significant level of preventable disease in wcrker~, and OSKA', proposal would require all employers to designate Vii individuals to coordinate IAQ activity within the employer's place of bu,ineas as veil a, with any applicable buil~ing management~i.~ Martonik insisted that the proposed rulein n3 way prohibits individuals from smokin9 but only restricts where they .my smo~ to protect non-smokin9 ceworkers from the adver.e health effects ETS. He claimed that it was not the intention of OSKA t= workers from usln~ a legal product even if it ~ harmful to user. He est~mated tha? ~he proposal would affec~ 4.4 milllon~i buildings and 70.7 m/llxon workers. ~e estimated the number employees expose~ to indoor air pollution to be 21-2 million, the number of buildinss with IAQ problems to he1.4 million. Marronlk claimed tha~ GS~A's preliminary estimate of the annua~ cost of compliance with th~ IAQ s~andard would be $8.1 billion~ of which the most costly provision is $8 billion far the buildin~ system's operati~n and maintenance. He claimed the cost ~or eliminating exposure to ZTS is estimated to range from zero dol~lars to 68 million dollars dependin~ o. whethe~ employers establish~ smoke-free workplaces or ~uild designated smokin~ areas. A~though Martonik concluded hi~ ~tat~ent by claAmin~ that a limited =mount of time was available for q~Aes~ionlng t~ OS~A panel, the judge t~ok a very lenient position with respeo~ to the length of time he would allow for examining the OSHA Judge Vitone began by askin~ al] interested ~arties who lesirei~to ask questions of the OSHA panel to stand and approximately 12 individuals did so, includin~ several on behalf o£ the tohacc6~ industry At approximately I0:50 a.m., Ted Grossman o~ Jones y Reavis & Po~ue, rep=esen~in~ R.J. Reynolds and other individu~s who had filed proper ~Ioti=es of Intent to Appear, began his examination of the panel. Grossman questlomed whether a work~ could sit in his ~ office with his door closed and s.~oke a cigaret~o, ~o which Martonik replied in the |~egative. Notin~ the proposed regulation anticipated no losses in work or productivity and perhaps even some gain, Grossma~ wondered whether OSHA had allowed for smokers leaving the workplace to go to 51268 2344 .~, "~2
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.rooking lo, nge or outside the building, and Martonik r<~plied tha~i this had not been considered. Next, Grossman suggested that smokers may lose concentration and develop anxiety ~f prevented from smoking, which could result in a loss of productsvzty rathe~i than a ~ain. Grossman then su~geste~ that OSRA was imply~n~ tha~i cigarettes were no~ addictive in l~ght of their proposed regulation, but Dr. Silverstein that denied any such made b~ the agency. Grossman questioned why OSIIA zade no attempt to characterize the level of risk ~ttr~but,ble to ETS e~posure e~ce~ with respect to fun, cancer and heart disease. Marton£k i~siate~ that the st~£f had ~eviewed =~i th~ a',a~l=~le scientific papers concluaed t~at they were not adequate to propose a qunntitative risk for diseases other than lung cancer and heart disease. At this point, Martonik stated for the first of times what is obviously 9oing to be a frequently used "safe during these beatings. MarT.onik insisted thac the ~roposed was very preliminary and the purpose of these h~arin~s was to the assistance of the public and interested industr~ observers that OSHA could pr~uce a better ~inal rule. Throughout the whenever tough questions came to the panel members, they would retreat into the "safe harbor~ ~nd appeal to the questioner help in reaolvln~ ~hese M~rtonik dies,reed with Gros.man's assertion that the U.S. SUpreme Court in i~s Benzene decision required OS~A to quantify the risk in all .tanderde. Mart0nik e~pressed the vie~ that the quantification of the risks for lun~ cancer and heart d~sea.s excused Uhe agency's failure to ~ntify the risk for ot~er ~Iseases and demonotrated a eu£~iclentl~ s~ni risk to ]usti~¥ action in the form era proposed rule.ficant ~oting that ~ince companies have adopted private smoki~ policies fewer smokers are being exposed to smaller amounts of each day, Gross~an asked wh~ the agenay was relyiug on workplac~ smoking date, which was several years o14, rather than what he =untended would be lower current figures. Martonik feebly that the agency tried to use the bee~ available evidence. Grossman ne~ turned to %he 32 ET~ studies and began atta~k~n~ so~e o~ ~he methods OSHA use¢~ in h=ndlln9 these studi~. Grossman accused the agency of "rounding up" with the effect of si~nifiuant1~ increasin~ ao~e o£ the mathematic.l figures. Martonik promised to checkon how those figures were handled an~ report back. GEoseman no~ea that the abilit~ o£ the public to comment on the propo.ed rule was llm~ted by the quality of the ~ta in the regulation. He noted that if ~.here were math errors, "round£n~ up" errors, or assumptions in ~he studie~ that were
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to eneble it to properly commertC, M~rtonik indicated that the ~i agency had tried to do its best and acknowledge4 that it could h~e overlooked some matters, but he was optimistic that these hearing.: would help identify any of those problems. At approximately 11145, OSHA Attorney Sherman to the ~udge t~t othe~ individuals wanted to question the and perhaps it was a good idea to p~stp~ne Grossman°s further questioning. The jud~ generally a~reed and ~g, in asked tha~ individuals wish£ng to question the ~an~1 ~t~nd. A representati~ of the National License Beverage Association asked several quostlons, including whether OSHA regulations ,uch as that helng proposed would npply to indian reservations and the clsinos that were "popping up." Martonik did not know the answe~ to this question and prom/sed to ~et back to the ~entlema,. The next questioner was Anne Morrow Donle¥ representing; the Virginia Group ~o Alleviate Smokin~ in Public. Hs. Donle~ wanted to know whether she would be able to ~sk questions of tobacc~ company rspresentatives b, cause "they have re£use~ to us information in ~he past." She also tried to ~et the panel to insist o~ inquirin~ of each witnes~ as to the e~tent o£ tobacco compan~ contacts ~ut Martonik indicated that this ~ould not ~e ~equired. Donley also wan~ed the panel to look a~ "economic ~ckma i bl~ li~g" in. arrivin~ a~ their decision ~nd tried to 9ire tha~ panel several examples of wh~t she saw :s improper conduct by th~ tobacco industry such as boycotting non smoking restaurants. concluded b~ begging the panel not to exclude taxis ~nd limousin~ ~r~m ~he ~=opose~ r~ulat~on because ,ens~ive £,a~vi~ual, rld~n~ zn a cab after a smoker could become ~.II. Ns. Donley ~e schedulq~ to testify later in Ocbober. A =eprceen~atlve o£ ~he AFL-CIO aeMed a £ow administrative questions about the number of buildings estimated~o 5e covered 5y the proposed re~ul~tion, ~nd th~s was followed by few questions from Jim Dinegar of the Building Owners and Mainten~n=e A~so=iati~n. The thrust of his questions made it cl~r that BOMA's position i, that ETS ~hould be considered separate apar~ ~zom all indoor air quality subatance~ and that a simple a~t of banning smok£ng inside building~ ~ould eliminate the need this regul~tion. After a few question$ by a representative of the Servi~ Employees International Unione Judge Vitone recessed for a one-h6hr lunch break. Upon resumption at 1130 p.m, Myron Wineberg [sp?] ~~ challen~d ~he ~an~l w£~h a ~eri~a o£ qua=rich= ~out how t.hey arrived at ~hoir ri,k a,sessmont on ETS. Wine~er~ emphasized th~ OSHA had based its risk assessment solely on the Fonth=m study despite the fa=t that other studies existed. Mart~,,ik zeplled t~t 51268 2546"~
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support of its rul~akln~ authority end po£~nted out possible i:~ problems with each one. Martonik ~eplied that there were hundre~.~ of ~tudies tha~ the ~taff had to consider, ~d OS~ consAdered :~::
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these throe to be the moan relev&n£ to its inquiry. He insisted ~'~ that the staff would look at any new information Rupp thousht they~i .hould consider. Rupp then p=oceeae~ ~o que.tion the vaiidit> of th.t 0S~ d~ not cite a~l of ~he o~o.zn~ or inconclusive and Rupp ~1~mea that the publ~c was only ~et~.9 "one-halE of 8to~." Dr. S11verstein earnestly replied, "We ~ant to get this right -- it could be tha~ we h~ve 9often thi~ wren9 and p~=h~ps under.~ated or oversta~ed certain i.aue. -- please help u. do it ,~'~ right " Rup~ next ~.s~oned ~hethel 0S~ had ever cited "irritation" ~ the bas~, f~r a pr?po.ed rul. ~n th. workplace. ~to.~k insi.t.d that und.r cartel, c~rc~stance, percep~o.s of~ irritation can make irritation real .~nd thereby justiEy regulatlo~i At this point, a gentleman in the audience started sigr.al~ng to the .~age hy point~ng to hJg w~tch. ] later learne6~ that this wa~ Chuck Golden, head of OS~'s Office o£ the Solicito~, and he ~aa trying to signal Sue Shaman to get ~er to interrupt a few m~ent., Sharon obJeoted to ~he length of the ~ueationin~ ~d tried ~ get another ~reon ~o the p~ but the judge ~lt~ed Rupp to contXnue f~r a few more minutes. ~pp then pzoceeded ~o quesexon the agency's rmiian~e surve~ data "~he~e people clawed they ha~ been il~ ~he presence o~ at least one cigarette within the l~t two weeks and ~o use basxs for ~le~kin~. Rupp pointed ou~ ~ha~ i9%1 da~a showed rosbri~ions, includ~n~ 34 percent of which banned smoking. Ha~tonik reluctantly agreed with Rupp that it was not mezely enough ~o know the fact of exposure tO E~S but you also needed to know ~e frequency, ~he intenei~¥ and ~ho ~uracicn o£ exposure in order make good judgments. Rupp wondered ~hy OSBA believed that vanti~ati3n was adequate to deal with all uthBr toxic fumes in the workplace except ETS. Martonik insisted that i~ was hard eo contr~l an~ by ventilation and claimed tha~ OSBA co.c[uded that ve.tilation • would not be able to reduce ETS ]sve1~ based on at~ong enginee~x~ da~a. ~"~ At approxlmate~y 3:40 p.m., Pat Sirridge of Shook, Bar~ & Bacon, representing Ph~l£p Morris and several other indiv£dual~ ques¢ioned ~he p~nel brlefly. Sirridge'~ quesuio~m fucuaed cn ~e 51268 23~,8
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a~ency°s .tro.g rel~ance on theHelsing study with ~e~pec~ to as a cause of hem~ disease. The panel acknowledged that i~ agreed that Helsing studied only white people and claimed they did knQw the r.cial breakdown of the U.S. workplace, although they agreed that not all wormers in th~ U.S. were h~te. BecomAn~ unco~ort=ble0 ~=tonik and Silverste£n tried to ~.ndle a eerieS~ ~estions about why they had not a~usted the conclusions of th~j~ Helsing study to the reality of the rmclal makeup of the ~eric~ workplace. ~nAk indicated that OS~ believed t~ effect of ~S Next, S~rridge wondered why OS~ relied on ~ eln~le that had no workplace e~oouze data ~hile other .fudges which contain workplace e~ouure d~ta were not used. Martanik that the agency thought that the occupational data was not rel~le but agreed that such data would be preferable ~f At was ava£1ab~ and reliable. Sirridge co.cluded his examination by pointin~ o~ a series of poeslble errors that had not been proper~y acc~unte~:~ ~or in umln~ the Helei-~ .tua~ to arrive a~ the agen~'e uonclu~on that ~lemaking was necessary i~ the ETS are~. At 4:10 p.m., Pat Tyson began his extinction of the ~-~ panel. ~tonlk ~c~owled~ed that OS~ had received over I00,0~ c~e.ts on the proposed regulatio, a.d clawed ~hat the m~ori~ has already ~en opened. ~son asked, "H.v. you o~ned Philip Morris' c~ent~ yet?" After a ~ick huddle by the panel, F~rt~lk tries to evade the ~eation but it was clear that the c~pnny's c~ents ~d not yet been con.idered. Marton~k acknowledged th~ OS~ ha~ not yet reviewed a m.jority of the co~ent. It had ,~ received .... Tyson pcoceeded to =aM the panel if it was :eally posit~on that the purpose ~f the proposed regulation was to eliminmte all no.-smoker exposure to ETS. Dr. Silverstein fairly auimatea dur~n~ |~ explanation and claimed that the preamble to.th? regulation which containe~ this statement was error. He ~ns~sted that the purpose of the regulation was to ~ oli~nato a si~nlficant rink but eventually and reluctantly acknowledged ~t if tht. ~oa]. could only be ac~o~lishod by ' halve el~InaCing all non-s~okera e~sure ~o ETS, then that ~uld to tame place. Dr. Silveratein di.ingenuously argued that eli~na~ing all non-smokezs" ex~sure was not a pu~ose bur was~ significant risks. After getting Dr. Silverstein to agree that there sa£e level o~ exposure to ETS, ~non ~an a .p~.ritea dialogu. ~ith h~ about whether th. agency had ever regulated to a zero risk ~n any prior occasion. 5Alver.t.An i.sA.ted that OS~ had use~ An one thous~d stand~d of ri.k ever since ~he U.S. Suprem~ C~
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issued its decision in the Benzene case 14 years ~go. Feeling s~ewhat trapped, Martonik trxed to claim that 5he agency could lower than the one in one thousa.d risk 3tandar~ and tried to that ~ome o£ the risks in the wolkpla~ due to ~TS approach this sta~ard in terms of severity. Martonik claime~ that the agency wo.ld have ~one after even s~a~ler =£sk ~a.da~ds but i~ had "higher priorities." He als~ insisted that another /actor to be coneldered was the number of people ~ho ~ould beex[o~ed to the substance and in the ETS area this was a substantial number people and therefore a substantial ~==t~r ~ be c~nsldered. Tyson then had Martonik confirm ~hat the proposed regulation would prohibit any work in a designated smokess Tyson hypothesized, s,tu.tion wh.r© ~e wen~ i ~ ~ smokes, ro0~i with him £o read while doing so. Marcon~k and $ilverat~in becam~i visibly uncomfortable as Tyson used this and a sAm/tar series of questions to point ~u~ enforcement difficulties with ~he reOulation. When Silverst-~. tried t~ cl~m ~ha: OS~A o£fice~s ~ou~d pro~ably ~ook the o~he~ wa~ if they saw Tyson read~n~ a brief while in the smokln~ room, ~son reminded $~ivsrstein that the law establishin90SHA mandates compliance officers to cite an~ violations they observe. Tyson also wondered about the logic of permitting" to voluntarily expose themselves to ETS if they went into a smok~ room while prohibiting a n~n-smokin~ wo~'ker to volunt=~il¥ h~ or hersel~ to ETS should the~ s~ desk.re. Si.lver.te~n ins~ste~ ~h~t there were too ~ny pressures on wo:kers to purm£t non-smokers t~ make such decisions freely. At th~ point, Silverstein launched the only aUtack fr~ the p~el on the ~stioner. albeit a very ,~eak one. 1n response to Ty.on's las~ question, SilversteAn insisted ~hat the a~ency was t~in~ ~o be re=son~le and acco~odate non-smokers" rights. Re wondered ~n the abstract whether Zyson was aavocatln~ that .~okers and non-smokers be s~e, the onl~ alternative £o= OS~ ~ould be to ban smokin~ in t~ workplace for eve~on~. ~"* Tyson ~hen posed a series o£ questions to ~he panel on diane=eat factual sAt.a~ions. In each i~stance, ~son wonder~ whether a violation of ~he proposed re.lateen wo~idhave occurr~. He ask~ questions ~out circumstances in private r.a~dences plu~er .nter~d a private home ~ conduct their business, ann = hotel sleepins ro~ would be classLfied for enforc~ent In each instate, ~rtonik ~d Silverste~n re~rea~ed in~ ~he har~r" a~ insisted that was exactly ~,hy theoe ~earin~0 were be~n~ re~i£iod in advance. ~il~-er~toi. acknowledged tha~ there ~oro :~'~
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many di£feren~ mc.narios, and h~weleomed the advice and input ~ysoa and the othe~ witnesses who were go£nq to At 5:05 p.m., Judge Vltone ad~ourne~ to consult ~Lth thai individuals who ha~ indicated they had addit~on,l questions for panel. At 5:30 p.m., the judge reconvened the .ession and ~nnounoed that q~est£onlng vculd continue for nn additional hour and th,t the panel would return Wednesday morning for two or hours of additional question~n? ~y individuals if that nsoessary. The only individuals with additional questions ~ere Grossman, RuDp and p~ssihly Tyson It appears that Dr Phil~p Horsy, OSI~'s scheduled ~i~ness for today, will not ~estify order on Wedne.day but rather Stanton Glantz and Michael the witnesses orlglnally scheduled for Wednesday, will te~ti£y after the panel is ~uestioned in the morninq. This effort by Virone ~o ~o~eh~ ~et hack on schedule ts highly dependent on extent to which the panel, Glan~z and Hod~eon are ex~in.d after providing their direct testimony. Gross~n res~ed h~s examinatio, of the panel by out that there were several wvll-=eco~niz~d ~over~ent ~n risk asse,sment and clawed the panel had not followed well- recognized standards in ~r~vin~ at its conclusion,. Grossm~ e~ked on a battle with Ma~tonik ~d Silvezstein over the a?vn=y'm classifica~iun of the various studies as either positiv~ ~ivoual, posit&re trend or o~ivo=al, cla~in~ that no such cl~sslflcation was re=ounized in the field of epldemiolo~y s~atls~i=.. Grom.~n aiso confronted the pano~ ~ith statemen~ in a brief in ~he Ash litiqat~on of 1~91 which stated ETS occupational exposures differed dependxns on building size, type, and ventilation exchange rates. Martonik seemed uncomfortable with Grossman's question implyin~ that OS~A was no~.~,~ us~n~ a different standard and ~u.d that the'lg~l lawsuit involved a req,est to implement a Emergency Temporary Standard a,~ the standard £or such a regulation wa. much higher than what was being proposed at the current' time. ~ter having the panel admit that they had not read ~.~?~ Reynolds' submission. G~oss~n explained that the company had conau=ted a meta analysxs of the workplace studies utilixin~ that ETS ~ae a uarcino~en. Grossman clffi~ed that when eel's st~f reviews the metn analysis they will find that the relative risk the w~rkplaue due t~ ETS is one -- in other word., no inc~eamed rlsk. Grossman wondered ~ther OS~ had ever trie~ to that they had done so in the past but without .peci~ic
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G~ossnm~ ~hen ~ook up Si~ridg~'s at~ac~ on ~he Belalng study and initially obtained an acknowl~d?e-*nt by Hartonik that OSBK had not considered confounding factors in the study such as diet, souio-e~on~ic ~actors. a~cohol and otJte~ home Grossman also claimed that. the EPA had submitted a c~mment into record claiming that OS~A "had misstates and o~e~,tated" some o~ ~he d~a. This caused ~ brief per~ of =onfus~ ~ong the since no one had app~ntly ~e.n these ~p~rently critical c~ent~ R.turni,~ to the i.su- of why OS~ used a non-workplace study when ~orkplaue ~tudies .xis~ed, ~ar~onik expla~n.d that ch=n~e j~s and therefore change exposures over their ~rkin~ li~e~ ~e claimed OS~ wa. no~ ignoring the uozkplace ~%ud~e~ bu~ that When Dr. Silver.te£n claime~ of a t~esh01d levml of ~T~ that was that Dr. R~pace h~ published such a threshold, and this caused much co~otion on the p~el -£nce Dr. Re,ace was s~utin~ directly behind D~. Silver.rein at the t~me. Dr. Silverst~in continued insist that ~h@ agency did not t~nk there was available evidence to just~ a threshold d.~erm~nation for ETS. would haDpen if the~ allow-d smoki,g in as it is restricted today and proceed to ~p~ment the IA~ an.wet for thi. but did clai~ that n the e£fect of simply .eparatln~ smoker, and. n0n-smoker, possible solution to the IAQ problem. tha~ G~ssmao ~inish .~ithin the n.xt th. court that he had 20 or 30 a~iticna~ minute, of ~esUionin~ better job of fo~mulatln~ the best possible IAQ regulation. repoEted ~hat OSHA h~.~ even paid a public relations f~rm to it in its dealing with the public durlng.~he,e hearings. and suggested that the hearin~ be adjou=ned for the evening ~.nd would resume in the morning. Judge Vitone accep%ed this rec~endation and t~ he~r~n~ adjourned at 6'~35 p.m. .~..~ ~-erall, the heazin s be~n~ condu:~ed in an ex reme dignified and l~w-keyed man,er. ~t's cleaz £hat OS~ has aecided to present the appearance of wantin~ ~o use.~ ~hese hea=Angs to elicit co,ants and suggestions %~ enable At to 9-nuinelM do a As ass i
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Althou~h ~he hearings ..are definitel~ 1ow-ke~, :.they anything but humorous. ~n contras~ to most trials where an .,. leeway ~o the ~esnioner and the re.pop,dent. The one or M~ia interest ~s be.n m~rate. F~ve ~alevis£on ..... rear of ~e ~udit~r~, ar~ the c~er~ £roquen~l~ ~e ~0 a ..' ~~" sep~ato stage ~Jacant to the healin~ sta~o to ~et di£~or~nt an~les for their shots.. P~l~c relatlons pers.3nnel were television s~ce n~e of th, u~ras display~ ~ogoe. ~c~ ,~ ~. Wash£n%~on, D.C. 's channel 4 (N~C) had a came=a in plac~'~o~..~ of the day but al~ but two cameras packed up and left approx~ately 3:30 p.m. CBS national n~ws c~ried a hearings th~s Although the h aring 2ere ved to Helen Audttori because of ~he an~iclpat~ czo~s -- they di~'t show up. Approx~tely o~ ~ho~sa~ chars were set up on the floor auditori~ bu~ one hundr e0ple, oat =ffil~a~ed w~h the tobacco ~ndun~r~, nhoved up £or ~be of the hearinq. ~ ~e d,y wen~ on, the crowds dwindled e~ of the ~ fewer th~ fifty ~ople wore In att~ndan~ The he~ing will res~ at 9~00 a.m. t~orr~.~w~h'~: continuation of the ~Jest~onin~ of the OS~ panel, St=nton Gl~tz" ~d Dr. H~son's test~ony. 3udge V~one obviously t~ing to get back on schedule but if these witnesses is c~par~le to that .Jhich was conducted • notheE schedul~ shaft could b~ anticip,ted foe Thursd,y.
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OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE DATE: September 21, 1994REPORTER: ALLEN R. PURVIS~"~.i SHOOK, HARDY & BACON Despite another day of testimony that again extended.~i into the evening hours, only one of two witnesses scheduled for~'~i today were actually able to testify on behalf of OSHA. The delays<~i experienced today combined with yesterday's delay prompted several.~i tobacco industry attorneys to move Judge Vitone to consider<~i adopting a new schedule for the hearings that would substantially~i extend the hearings beyond the end of the year. Today's testimony'~ and questioning of one of the leaders of the scientific anti-~5 smoking community produced the first signs of contentiousness,~., although still at a relatively mild level. At 9:20 this morning, Grossman resumed his examination~ of the OSHA panel with respect to their reliance on the Fontham<~ study which established a risk ratio for lung cancer due to ETS. When Grossman wondered why other applicable studies were not\~i relied on, Debra Janes responded by claiming that the Fontham!~ study was superior to all others that were available to OSHA.~ Grossman pointed out that the Fontham study did not control for~.~ alcohol or beer consumption and Janes weakly countered that the'-$~ researcher had controlled for diet but conceded that this may have included alcohol. Janes was not familiar with the recently{ study associating lung cancer with Chinese food and, as Grossmar~'-~ continued to pick apart the study, Martonik advised that the panel'~'~ was not prepared to identify everything else that the panel hadi~'.? considered in arriving at their decision to rely on the Fontham~i study. Grossman continued to ask whether the Fontham study had~ accounted for proximity to cancer "hot spots, " proximity petrochemical plants, and whether it controlled for pesticides, which Martonik replied that he did not know. Grossman next challenged Dr. Silverstein's initial~[.~ statement that over 4,000 chemical compounds had been identified in environmental tobacco smoke. The doctor reluctantly agreed~ that this figure applied to mainstream smoke and he acknowledged~ that only a few hundred had been identified to date ~n ETS. Dr.~ Silverstein quibbled and tried to suggest that the agency believes~ 1
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that there really are a large number of chemical compounds in ETS even though they have not yet been identified. Grossman turned to figures in the proposed rule with respect to the locations where individuals were exposed to ETS and!~i noted that OSHA claimed that 51 percent were exposed during dining~ at work, 35 percent during breaks at work, and 35 percent at home -- only 27 percent were exposed at their actual work stations .... Grossman emphasized that it appeared OSHA was trying to regulate the less likely place for ETS exposure and wondered whether the agency had studied the simple solution of separating smokers and non-smokers in the workplace, to which Dr. Silverstein replied in the negative. Grossman again referred to Dr. Repace's article which Grossman contended established an ETS exposure threshold. Dr. Silverstein was forced to claim that the Repace article had some problems and, in any event, the article concluded that dilution ventilation could not achieve even the threshold level Repace had established. At I0:00 a.m., Rupp began his resumed examination of the panel by returning to the subject of how the staff had gone ~about categorizing various studies as positive, unequivocal, or unequivocal with positive trend. Janes explained that a positive/~,~ study was one which was determined to be well-designed and~ conducted, internally concise, and showed a statistically significant association. An equivocal study would have the opposite conclusion on the three criteria, while a trend category ~ would be one which satisfied the criteria with the exception of a statistical significance but which showed a trend in the data toward a statistically significant goal. Rupp then applied these criteria to the Brownson study T~ and pointed out that the statistical significance was 1.0 or, in other words, there was no statistically significant association. Janes seemed shocked by the statement but refused to accept Rupp's representation and merely promised to take a look at the study and "re-evaluate if necessary." Rupp next questioned the panel as to how its expert~ witnesses were selected and whether a demonstrated anti-tobacco~ industry bias would affect OSHA's reliance on that witness' \~ testimony. Martonik indicated that he thought that previously testifying against tobacco companies in litigation was an . irrelevant factor, to which Rupp suggested it would not be irrelevant under the Federal Conflict of Interest Rules. Rupp next referred the panel's attention to a letter and the comments received in response to the proposed rule from a 1.094,4933 51268
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layperson complaining of and describing adverse contact with ETS in the workplace Rupp wondered whether the tobacco industry~ should be prepared to balance such non-scientific, anecdotal~ letters with similar type letters or whether the panel was going:~i to disregard such unsubstantiated claims and rely, instead, on the ~i expert testimony received during the hearing process. Dr..~ Silverstein tried to walk a tightrope by initially suggesting that such letters were not significant but he then realized how this would look to the lay public so he quickly reversed himself and suggested that it would not be correct to assume that all lay reports have no meaning in the OSHA evaluation. Rupp next asked the panel whether they were familiar,.~i with a study which demonstrated that when nonsmokers in a restaurant were unable to see ETS due to plants or other barriers, <~'$i the level of complaints about ETS dropped to that of a background level. After the panel indicated they were not familiar with this study nor had they considered remedies based on this study, Rupp won a concession that fumes similar to ETS are emitted in the kitchen areas of restaurants but OSHA is not proposing to require separately ventilated exhaust kitchens. Rupp completed his questioning of the panel by asking how much a violation of the IAQ rule would cost an employer if the rule is eventually enacted. Dr. Silverstein tried to avoid giving a direct answer, claiming that the amount depended on whether the violation was classified as serious, wilful or a repeat violation, and he also noted that the amount could be adjusted downward due to other factors such as good faith or upward because of the size of the business. Rupp concluded by winning a concession from Dr. Silverstein that it was very likely that a violation of the IAQ rule could cost an employer $7,000 • At 11:35 a.m., Bob Harrington of the National Restaurant Association asked the panel a few concluding questions. Martonik acknowledged that OSHA had not studied other indoor air quality problems in restaurants separate and apart from ETS. Harrington wondered how OSHA could extend its rationale for control of IAQ in office buildings to the "unique setting of a restaurant." Martonik claimed that problems with the capability of ventilation systems were not unique and could be generalized to all buildings. Harrington referred the panel's attention to the term "building related illness" which is described in the proposed rule • as "ill defined and often confusing -- difficult to characterize." Harrington wondered how an employer in a restaurant setting or any~ of the settings for that matter was supposed to be able to diagnose BRI and determine if it was attributable to the worker's~.~ exposure to pollenon his way to work or ETS while at work. ~o~n 51268 2356 "~
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Harrington ended his questioning by discussing the facq--~ that in a trade table sergice situation such as that found in most~ restaurants, the proposed rule's prohibition on employees enterin~ into a designated smoking area would operate as an effective ba~ on cigarette smoking in restaurants. Martonik replied, "We sensitive to these concerns and we are willing to listen." At 11:50 a.m OSHA called Dr Stanton A. Glantz as its~ first witness. Glantz holds a Ph.D. in Applied Mechanics an~'~i Engineering Economics from Stanford University and is currently a~i Professor of Medicine at the University of California, Francisco, in the Division of Cardiology. Glantz had previously~i submitted a 48-page statement complete with 97 footnotes; however,~i he spoke extemporaneously and did not cover all of the points set~i forth in his paper. This was due in part to Glantz's need spend the first few minutes of his testimony attacking the tobacco~i industry. The essence of Glantz's initial testimony was that he~ had observed industry lawyers attacking the panel by nitpicking~ various studies they had relied upon. Glantz urged the panel to~ recognize this tactic for what it was and gave a history of what~ he perceived as the industry using this same tactic for decades.\~ • Glantz illustrated his comments with 35 mm slides of var~ous~ scientific charts; however, his first slide consisted of a cartoon~ showing the Grim Reaper seated at a desk in front of an open<~ window looking out on a graveyard. The Grim Reaper was labeled "The Tobacco Industry" and on his desk was a sign that said,~ "Prove It." Glantz then proceeded to compare and contrast modern~ attacks on ETS science by Philip Morris and R..J Reynolds by~ showing that these same types of attacks had been conducted on the~ primary issue in years past. Glantz showed the panel slides of~ TI's Barron's ad in 1967 as well as the 1981 TI ad which attacked Hirayama's study on ETS. Glantz's testimony on the merits was impressive and he .... is, by virtue of his position, an obviously well-respected scientist in the field of cardiology. Glantz reviewed a series of~ studies that he had either conducted or relied on in arriving at~ his conclusions that ETS is a far greater killer of nonsmokers due2 to heart disease than it is a killer due to lung cancer. Glantz~ theorizes that ETS causes between 30,000 and 60,000 heart disease deaths each year while lung cancer only causes between 3,000 and 5,000 deaths each year. Glantz explained how he believes ETS affects the heart. ~ His data seemed to support his claim that ETS affected the ability~ of nonsmokers' blood to deliver oxygen to the heart muscle, thereby increasing carbon monoxide levels in the blood. He also~ cited animal studies showing that passive smoking reduces the ~o~ 51268 235~
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ability of the heart muscle to convert the oxygen which gets the heart into the "energy molecule" adenosine triphosphate (ATP)~! which Glantz characterizes as a "little chemical battery that i~ then used by the cell to power the energy-requiring processes." Glantz spent a substantial time discussing his research.~i which he claims supports his theory that ETS creates "sticky.[~i blood platelets which "aggregate inappropriately and form thrombus" that can precipitate a heart attack. Furthermore, he~i cited studies which he claims support the contention tha~i nonsmokers are much more effected by ETS in terms of generation of sticky platelets than are smokers. Changing hats, Glantz described how he had accepted th~i challenge to disprove the tobacco industry's claim restaurants would lose up to 30 percent of their business if went smoke-free. Glantz gathered restaurant sales data from California State Board of Equalization and used various models t~ analyze the impact on restaurant sales in 15 cities that ha~ enacted smoking bans for restaurants. He smugly proclaimed tha~ his study showed absolutely no effect on sales when a smoking ba~ was implemented. After an hour lunch break, the group assembled to begi~ the questioning of Glantz. However, Tyson first approached thef~ microphone and made an informal motion to Judge Vitone that h6 consider adopting a schedule that would require two weeks o~ hearings followed by one week with no hearings. Other ~ndustry'~ spokespersons joined in the motion but the representative of BO~ opposed the motion and recommended, instead, that the Judg~ enforce the ten minute limitation on presentations and cros~ examinations. The Judge indicated that he would look at th~ schedule and suggested that he favored more break time but he wa~ not prepared to rule on the issue today. After a few questions by Dinegar of BOMA, Sirridge bega~ his examination of Glantz. Sirridge began by implying that Glant~i had volunteered to be an OSHA witness at these hearings and Glant~ bristled at the suggestion while claiming that he had "in no suc~/~! way" done so. Sirridge then questioned Glantz as to his clos~ contacts with several of the other OSHA witnesses who will b~i~ testifying at the hearing, including Repace, Wells, Benowitz an~ Hammond. Glantz again bristled at Sirridge's suggestion tha~ these were all fellow workers and argued that they were merely~'~ friends and acquaintances. He objected to Sirridge's~ "mischaracterization" of his relationships with these individuals. Sirridge then directed his questions to the reliabilit~ of the Helsing study and noted that there are many risk factors.% ~o~ 51265 2358 ~
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for heart disease and these had been set forth in various llsts~ appearing in the literature. Glantz anticipated that Sirridge referring to a particular list with over 200 different factors it but dismissed it as "silly" because it involved double and~ triple counting. Glantz was forced to acknowledge that factor~i such as age, sex, family history of cancer, cigarette smokingql status, cholesterol, diabetes, obesity and Type A personalities~! should all be considered and controlled for in a good study.<~ Sirridge then challenged Glantz to identify how many factors one! this list were accounted for in the Helsing study and Glantz.~ uncomfortably cited age, housing and socio-economic status.!~! Glantz then launched into a defense which tried to suggest that~i the category of socio-economic factors included many of the othe[.~i factors Sirridge had listed, such as diet, obesity, cholesterok~ii and even diabetes. When this line of questioning continued fo~i several minutes, Glantz finally blurted out, "I don't think you'll~i ever find a study in which you can't find something to criticize. It would be nice but .... • Glantz continued to be animated when Sirridge referred~ to a particular 198~ study that Glantz referred to as a "piece of~ trash." Glantz seemed familiar with the subsequent history of~ this particular study and went on at great lengths to explain why~ it should be disregarded When Sirridge questioned why Glantz had not conducted~ the meta-analysis on the ETS workplace studies with respect to~ heart disease, Glantz simply claimed that there were too few .of~ them and the number of subjects was too small. Sirridge concluded his examination by questioning Glantz~ as to whether he had ever contacted anyone maintaining the large medical databases about lung cancer and heart disease to see if~ their data would yield information about ETS and heart disease.~ Glantz smiled broadly and said, "Yes, I just did so last week~ because I anticipated you would ask me that question." Glantz has~ apparently contacted the ACS but claims their information from~ CTSI or 2 was not appropriate for such studies. After a brief ten minute break, Rupp began the longest~ questioning of Glantz for the day. Rupp began by expressing his amazement at the range of Glantz's expertise -- advertising,~ economics, taxes, health and even addiction. In response to this~ statement, Glantz simply smiled broadly and said, "Thank you.'~ Glantz readily conceded that he was a long-standing anti-tobacco~A activist and that he had founded a nonsmokers' rights group in,~ California in the early 1980s. 10944933 .%,,
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Rupp then confronted Glantz with several of statements taken from a transcript of a speech Glantz gave in ~i Perth, Australia in April 1990 to the 7th Annual Conference on~i Smoking and Health. One quote noted that Glantz was gratified to ~ see that some of his strange, radical ideas of the early 1980s!~! were now mainstream ideas. In his speech he indicated that he...~ knew people thought back then that he was a lunatic but Glantz~I claimed to Rupp that this was only a joke and everyone laughed, which Rupp replied, "Yes, I know, I've listened to the tape " ~ when Rupp quoted Glantz's speech to the effect that "one of the great assets we've stumbled on to is the nonsmoker" and"~: tried to suggest that Glantz was actually pleased that nonsmokers..~i~ were being injured by ETS, Glantz erupted. Anticipating whereI~i Rupp was heading with this line of questioning, Glantz stated, "It's very important to state that my interest in this area flowed~ from my science and not the other way around " After a final quote from the speech where Glantz urged~ the audience not to be "health fascists" but to be "environmental lunatics," Rupp asked Glantz how he expected tobacco industry;~ personnel and others to take him seriously as a scientist in light of these comments. Glantz remained agitated and replied, "I'm a professor of medicine and my career depends on being first and being bright." He claimed that he was very proud to have been;~ very early in his recognition of ETS as a health hazard. Glantz<~ again defended his integrity and said, "It is absolutely not true ~q to say that I have in any way twisted science because of my~ politics. I would change my opinions if proper evidence was brought to my attention. The University of California, the State of California and many others have found my work to be of high ~ • quality -- the only ones who have not found it to be of hzgh quality have been the tobacco companies." After a final skirmish where Glantz wanted to comment on~ Rupp's continued implications of bias (which were denied by the.., Judge), this line of inquiry ended with Rupp entering five~,~ publications authored or co-authored by Glantz into the record.i~ along with a transcript of his Perth speech. ~ The tension subsided markedly as Rupp turned his~ attention to Glantz's restaurant sales tax/smoking ban study. The~.~ next hour and 20 minutes were spent confronting Glantz with~ arguments which undermine the strength of Glantz's conclusion that there was no economic impact on restaurant sales when smoking bans were enacted. With the assistance of Price Waterhouse, Rupp had~ analyzed the preliminary report of Glantz's sales tax study and~ 2? ~og~n 5~268 2360~ :'~
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noted three or four major problem areas. First, the Californi~i State Board of Equalization acknowledged in interviews with Rupp'~! office that the data Glantz relied on was restaurant and bar sale~i tax data. The smoking bans did not apply to bars -- restaurants. Another major probl~m with the data suggested b~i Rupp's questioning was late reportlng/early reporting. The Stat~i Board of Equalization collects sales tax receipts on a quarterl~i basis but if a restaurant or bar filed their tax~ return late o~i early, it went into the total for the quarter when actually filed~ rather than for the quarter it actually covered. Rupp suggeste~!I there were several instances acknowledged by California official~!i where this occurred and, furthermore, they indicated they woul~!i not correct the situation unless someone specifically asked the~',i to do so. when Rupp confronted Glantz with what Rupp described a "math error," Glantz became uncomfortable but immediatel~~ insisted that "it was not a math error, it's a typographical~ error." Glantz insisted that regardless of the typograph~ca~i error, the conclusions were based on the accurate data which ha~ been entered into the computer and he apologized for his poo~ proofreading of the article's manuscript. Rupp concluded his questioning at 5:20 this afternoonS. and the Judge summoned the interested parties to an informa~ conference during which he discussed possible solutions to scheduling dilemma. Again, no ruling was issued, but the Judge~ indicated that he may suggest that OSHA limit the number of~ witnesses it calls as one means of speeding the process. Grossman began his examination of Glantz at 5:40 this~ afternoon by trying to pin Glantz down as to what level of ETS~ exposure was the minimum level of harm. Glantz reluctantly~ conceded that he believes that even a single molecule of ETS woul~~" still be a threat to a nonsmoker even though he acknowledged it~ would be a very small threat. , in~ Glantz resisted Grossman s suggestion that he was favor of a smoking ban in restaurants and insisted that he only~ supported OSHA's proposal. Grossman next tried to set Glantz up for some questions-~ by having him commit to the disparity and treatment of commonlyi~ ventilated buildings under 0SHA's proposal; however Glantz was~ , visibly growing tired and refused to answer the questions claiming,~ he was not a ventilation expert. However, he volunteered that heo~ knew that his hospital had a common ventilation system and it had~ a massive air scoop up on a hill to collect fresh air ~o go~ through the system. Since people in the building complained when~i 51268 236~ I09~4933
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individuals walked by the air scoop while smoking, his institution,~i has now put a no smoking sign near the air scoop Srossman then e~barked on a series of questions laying a foundation for the differential in lung cancer and heart disease~i rates between /~erican, Japanese and European males which was~i inconsistent with their levels of primary smoking. Again, Glantz~ appeared tired and tried to avoid following Grossman on the path.,,~i tO the slaughter house as he had done with the common building~ ventilation issue previously Grossman concluded his questioning by asking Glantz how~ much heart disease would be reduced if OSHA's regulation was:'~i enacted. Glantz wearily stated that he had not done the~i calculations. After pausing for a moment, Glantz realized that could come up with a stronger answer so he blurted out, "But believe it would be a substantial reduction." As Grossman left the podium, he had Glantz concede that~ he was not a medical doctor and had never treated a patient with°~ heart disease. As Grossman sat down, Glantz fired the last shot and said "But I am a Professor of Medicine at my university." The final questioner was Dr. Michael Lowe, a~ toxicologist with Washington Technical Information Group of~!~ Washington, D.C. Lowe's 25 minutes of questioning sought ~o'~ discredit Glantz's reliance on certain scientific studies in bothi~ his written submission and his oral testimony. Lowe tried,~ without much success, to have Glantz acknowledge that many of the~'~ studies he had cited were smoking rather than ETS studies. Lowe~ also suggested that it was improper for Glantz as an instructor -h -~N experimental research design to draw conclusions from studies ~ at~ were completely different from those drawn by the author Due to the late hour and more likely due to the audacity~ of Lowe challenging his interpretation of the studies, Glantz,, erupted on several occasions. He accused Lowe of confronting him2' with quotes taken out of context and insisted, even over the:~ Judge's admonitions and repeated tapping of his pen on his desk,~}~ to read additional portions of articles into the record "to set.~{~ the record straight.~ Of the three OSHA witnesses scheduled to testify on the first two days of these hearings, only Glantz has been put on the~ stand Hodgson and Morey apparently will not testify, at least in the near future. Thursday's schedule will present the testimony~ of three individuals, possibly as a panel. Joseph Lstiburek,:~ Jonathan M. Samet, M.D., and Hal Levin are scheduled to testify. 51268 236~ i094~933
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Attendance at today's hearing dwindled to half that yesterday and as the day wore on, virtually the only remainin~! observers were approximately 25 individuals associated with the,! tobacco industry. Fewer television cameras were in place although Barry Sarrifin [sp?] of CBS News watched the middle~i portion of today's hearings. Sarrifin delivered the CBS Evenin~i News report last evening and presumably will issue another repor~)!i:.,~ this evening. The hearing on Thursday and Friday will be held at Department of Interior Auditorium, 1849 C Street in Washington~"ii Next week's hearings will be held at Hearing Room B, Interstat~i Commerce Commission Building, 1201 Constitution Avenue thereafter, beginning on October 3, the hearings will be held i the Auditorium of the Frances Perkins Building, U.S. Department o Labor, Third Street and Constitution Avenue. Although today'~ hearing started at 9:00 a.m., hereafter, the scheduled startin~}i time is 9:30 a.m. Tobacco industry observers were uniformly impressed wit~ Glantz's delivery of his direct testimony. He is obv~ousl~} knowledgeable, well-read in his particular field, and does no~,° exhibit a superficial animosity toward the tobacco industry.i~ Despite showing numerous slides of what he obviously thought to b~ tobacco industry "bad tricks," his manner of delivery suggested ~,'~ low level of animosity toward the industry. However, th~ transcript of his remarks will likely read in a more shril~ manner. The confidence and relaxed speaking style Glantz displaye~ on his direct testimony virtually disappeared during hi~! examination this afternoon. Even in this setting, where he is no~ii under oath, has an opportunity on occasion to make extende~?~ speeches in answer to questions and where his "mini-outbursts''~ went unpunished, Glantz revealed himself to be potentiall~ vulnerable on cross examination in a civil litigation setting. .% 5~26g 23~ I09~4933
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OSHA HEARING REPORT PRIVILEGED ANDCONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE DATE: September 22 1994REPORTER: ALLEN • . SHOOK, ~Y & BACON ,,,?... The hearing resumed today in a new auditorium, but results were the same -- the hearing continued into the evening hours. The morning session received the testimony of two engineering professionals on the mechanics of controlling indoor air quality. ETS was not even mentioned during their~-q presentations and their cross-examinations were few and brief. This was in sharp contrast to this afternoon's witness, Dr. Samet,~ who addressed ETS as a major IAQ problem and who was cross- examined well into the evening on his views. Judge Vitone spent several minutes this morning.~C discussing a possible adjustment in the future schedule of the hearing and, after receiving input from various participants• he-~ again deferred setting a new schedule until later in the day. The first witness was Hal Levin of Hal Levin & Associates, Santa Cruz California. Levin is an architect by training but has specialized in indoor environmental quality over the last several years. Levin°s presentation consisted of view graph excerpts~ from his 30-page written submission which he displayed in virtually random fashion. His entire presentation was delivered while facing the screen in the auditorium with his back to the audience Levin supports the OSHA proposal because he believes it makes good economic sense -- it is likely to produce improvements in productivity and building operating efficiency that will far outweigh the costs of implementing the rule. Levin devoted the majority of his presentation to reviewing the various elements he~ used in calculating the savings in productivity which would be achieved by implementing the OSHA proposal. His bottom-line opinion was that between 9 and 18 million additional work days~! would be saved by implementation of OSHA's proposal. Dinegar of BOMA was the first of three cross-examiners Dinegar wondered whether, in light of the significant work days to be saved under the proposal• the same objective could be achieved.,~ through market forces by merely informing building owners and 5~6~ ~6~ I09~5562
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employers of this potential savings. Levin replied that education~ had not worked, thereby justifying his support of a federal~i regulation in this area. After a few brief questions by Rex Tingle representing.~: the UAW, AFL-CIO and ASPE, Rupp began his brief cross by ot~ngq~ that there has been some suggestion that smoking outside of a.~ building can entrain and thereby represent an indoor air quallty problem for employees. Levin confirmed that he was not aware of any studies which suggested that entrained cigarette smoke was health hazard in the workplace. Dinegar then asked the judge for leave to ask two or~i three additional questions which left no doubt as to BOMA's cigarette position. Dinegar asked whether it was better to mix~ smokers with non-smokers in the workplace or whether it was simply~ better to let smokers go outside and smoke. Levin answered falrly that if the air could be recirculated properly, then smokers would~ work alongside non-smokers; if not, however, he would favor that~ smokers go outside. At 11:50 a.m., Joseph W. Lftiburek began his direct<~ presentation. Lftiburek is a Ph.D. candidate in civil engineering~q and has a masters degree in mechanical engineering. He has~.~ specialized in IAQ matters since 1982 and has conducted several hundred building investigations since that time. Lftiburek explained that a simplified IAQ system consisted of two parts: i)~ exclusion, and 2) capturing of the source of contamination. respect to capturing the source, Lftiburek indicated that the creation of a zone of negative pressure around the source of the~ emission is the best control possible. Noting that the propos~d~ OSHA rule mandated that any ventilation system in a building ~s required to be operated at relevant times, Lftiburek indicated~. that if this was coupled with source control, it would result in~ acceptable indoor air quality. Lftiburek believes that source~ control is the most effective and most cost-effective method of controlling emissions. Lftiburek concluded his presentation by~ showing slides of four different buildings he had investigated for indoor air quality problems. The vast majority of Lftiburek's data deals with microbial contamination and he did not mention ETS during his presentation. Before resuming~ cross-examination of Lftiburek after the lunch recess, Judge Vitone announced his decision on the request.~ for a slow-down in the schedule of hearings. He began by~ emphasizing that this was his proposal, even though it was based on the motion of several of the parties. He insisted that he was restructuring and lengthening the schedule because it has been his experience as an administrative law judge that holding sessions 51268 2~6~
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late in the evening was not good for the quality of the record.~i He noted that since this "may be the most controversial rule even$~i proposed by OSHA, " he had decided to slow things down a littl4~i bit. The judge then announced that hearings would not be during the week of October 3 and November 7. Witnesses scheduled~ for the week of October 3 will testify during the week of Decembe~i 5 and the witnesses scheduled for the week of November 7 will~i testify during the week of December 12. The group of potential witnesses scheduled during the week of December 5 w~l~i~ be rescheduled for an indefinite time in January; however, the~i period when the record will be kept open for additional comment~! and information will begin to run on December 16, unless Judge~i Vitone rules otherwise. It was also announced that the Philip<~ Morris witnesses currently scheduled to testify on September 30~ would be rescheduled during the week of December 7 Upon hearing that the Philip Morris witnesses were being~ postponed, Dinegar rose to object, claiming that this gave some~ advantage to the tobacco interest because it would avoid cross-~ examination until it had heard virtually all the direct testimony~ in the case. The judge and counsel for the tobacco industry~ queried Dinegar as to how it could possibly give the industry any~ advantage and, when he was at a loss to be able to explain his~ position, the judge let his ruling stand. After 15 minutes of brief cross-examination by three~ non-tobacco parties, Dr. Jonathan Samet was called to the~ platform. Samet is a Harvard-trained epidemiologist who is also physician specializing in internal medicine and pulmonary~ medicine. Although spending most of his career at the University"~ of New Mexico School of Medicine, he recently assumed his present~\ position as Professor and Chair of the Department of Epidemiology~i of the Johns Hopkins University School of Hygiene and public[~f~ Health in Baltimore. Samet's oral presentation and his comparatively brief~ 15-page written submission dealt in general with the problem of~ indoor air pollution with a particular emphasis on ETS. With a~ polished professor's speaking style, Samet moved rapid-fire~ through a series of view graphs which presented his views on IAQ.~ His major theme was that indoor air contains a mixture of complex~ pollutants and causes a variety of complex diseases. He note~ • that indoor air pollution can cause disease through a variety of~ mechanisms including immunologic, infection, carcinogenesis,--o irritants, inflammation and neurophysical. He described how toxic~ pollutants such as carbon monoxide, radon, ETS, and asbestos could...~ cause clinically evident disease, exacerbate existing diseases,~ ~0~ 51268 2566
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~0945S62 increase a person's risk for disease, impair human physiology~!~i (e.g., ETS exposure during childhood reduces the rate of lung~i growth), and other problems. while the preceding two witnesses made virtually no...~ mention of ETS, Samet devoted a two-page section of his written submission and several minutes of his oral presentation to this issue. He noted that since 1986 several groups, including IARC, the Surgeon General of the United States and NRC, have concluded that ETS causes lung cancer. He followed this with a brief discussion of the 1992 EPA conclusion on ETS. Samet concluded his/2~i presentation by noting that indoor air pollution is ubiquitous in~7-~i the workplace and its adverse health effects have been documented in the workplace. Dinegar of BOMA conducted a brief cross-examination that produced one unexpected (to him) response favorable to the industry. Asking Samet about a statement in his written submission indicating that one pollutant may diminish the effect of another pollutant, Samet replied with the example that ETS\. particulate matter sometimes binds with radon particles, thereby lowering their effectiveness on the human lung. Not liking this~."~ response, Dinegar concluded by having Samet rank ETS ahead of asbestos and radon as workplace threats. At 3:30, Grossman began what turned out to be a two-hour duel with Samet, who had performed a Mr. Hyde-Dr. Jekyll transformation. While presenting his direct presentation, Samet~ was rapid-fire in his delivery and supremely confident. When the~!~ tobacco industry cross-examination began, Samet changed completely - - his delivery slowed markedly, he quibbled over word definitions, he claimed ignorance on subjects arguably within his~$ area of expertise, and he bought time when backed into corners by asking for the questions to be repeated several times in a row. As with Glantz, Grossman focused his examination on the alleged relationship between ETS and lung cancer and OSHA's failure to properly account for various epidemiological concepts~ in its risk assessment, including bias, interview bias, confounding factors, occupational • exposures, family history of lung cancer and residence near known lung cancer "hot spots." When Grossman challenged Samet as to whether he would draw conclusions from a single study when several other relevant~ studies were available, Samet was obviously trapped and conceded~ that he would not rely on a single epidemiological study to make a determination of causality. However, realizing he had perhaps made a concession and perhaps not understanding its significance, Samet added, "but perhaps I would rely on one study in determining a risk ratio." 51268 2367 ~i
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AS Sirridge began his examination at 5:20, Samet' demeanor changed slightly as he realized Sirridge was well-arme~! on the data with respect to ETS and heart disease. Rather quibbling over adjectives Grossman had used in his questions,~i Samet frequently retreated into the safety of claiming he was not~! familiar with the studies or medical subspecialties aboutwhlch!~i' Sirridge was inquiring and therefore could not comment. Sirridge confronted Samet with his fairly recent article~i in which he suggested that the risk ratio for ETS-related disease reported by Glantz and others seemed too high comparedto the established risk ratios for primary cigarette smoking an~! heart disease. Samet reluctantly stood by his writing but made a.~o~ vain effort to qualify his earlier statement. Sirridge then examined Samet on procedural deficienciesi~<~ in existing ETS studies in general and then focused on the Helsing~-~ study's failure to account for numerous potentially confounding<~> factors. After pointing out that Helsing involved spousal studies~'~ and at least three ETS studies provided workplace data, S~rr~dge~l~ asked Samet whether he thought that the Helsing study was the bes~l.~ available study for OSHA's risk assessment. As was his tactic~.~.~ throughout the cross-examination, Samet simply insisted thatl[-~ OSHA's risk assessment was preliminary, although he eventually had}~[ to acknowledge that any risk assessment using Helsing would have~ to acknowledge that study's failure, as acknowledged by its owr~ authors, to account for various confounding factors and potential~-~ smoking history problems. Sirridge concluded with a torturous~ examination which finally extracted a concession from Samet that~i~ if it was decided that spousal ETS exposure studies could not bel~ extended to the workplace and sufficient resources were availableTM tO conduct another study, an epidemiological study of ETSi~.':. workplace exposure would be the preferable study to rely on for~ OSHA' s rulemaking Rupp began his cross-examination at 6 : i0 p.m. complimenting Samet on his many professional journal editorial~ positions. The majority of the rest of Rupp's examinatiori.~ consisted of confronting Samet with statements written about ETS~ and diseases other than lung cancer and heart disease. As an~.£ example, Rupp forced Samet to concede that his statement in a 1992~ book chapter to the effect that an association between exposure and COPD is "difficult to conceive" was still his view. After Rupp concluded at 6:45 p.m. and following a minute break, an additional, unannounced questioner was added toni the agenda. During Grossman's cross-examination, his questioning..~ suggested that the EPA's risk assessment was, in fact, in error~ii~ I0945562 5%26~ ~B6~
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10945562 and in reality showed no increased risk for lung cancer. Mr~ Repace was seen to be visibly disturbed during this questionin~.~.-~i and left the auditorium. Shortly thereafter, Steven Bayard~'~i Repace' s. colleague at EPA, came to the auditorium and frantie~"i consultations were held in the hallways. At 6:50, Bayard received~.~i permission from the judge to ask a few questions, and he somewhat~il feebly attempted to have Samet testify that the ii or 12 ETS..~ studies, nine of which were statistically significant, could no~;i have been adversely affected by any of the confounding factors biases raised during Samet's cross-examination. After a few inconsequential questions by Sherman OSI-~, Judge Vitone attempted to adjourn at 7:05 p.m.; however,~,~;i Rupp raised a point of order. Noting that tomorrow's schedule three significant witnesses is likely to continue well into night, he asked OSHA to consider dropping one of the witnesses After some discussion, Sherman of OSI~ agreed to consider thiN~) pos s ~bly~, proposal, although she claimed that at least one and ' others of the witnesses were already on their way to Washington. Today's transfer of venue to the Department of Inter~o~ Auditorium noticeably changed the atmosphere of the hearings. I~ contrast to the Melon Auditorium's high ceilings, columns and gold~i inlay, this auditorium more resembles a high school auditorium,:: although still replete with gold trim along the ceiling. Seati.ng~2~,! capacity is approximately 500, thereby cutting the opportunitie~}~ for the 30 or 40 observers to select their seats in half. Only Reuters television cameras were present in the~ auditorium today and generally a more relaxed atmo spher~ prevailed. Martonik was present in the audience in the morning bu~! Silverstein did not appear. Glantz entered at about i0:00 a.m. this morning carryin~.~ his huge backpack into which he had obviously stuffed his~ testifying suit. He was overheard to coI~ent to an acquaintanc~ that only the lead industry was as tough as the tobacco industr~<~ in opposing these regulations. The witnesses scheduled for tomorrow are Daniel Ford, physician who will testify about ETS and cardiovascular diseas~.~~ and lung cancer, A. Judson Wells, a retired Monsanto chemist wh~-..~; will testify about ETS and CVD, and James Woods, an IAQ engineer. ~569
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OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE DATE: September 26, 1994REPORTER: ALLEN R. URVIS~i SHOOK, HARDY & BACON'~i Today began the second week of the hearing and it place in a new location -- the third so far. The OSHA panel and.~i Judge Vitone received the testimony of three witnesses on methods~ to scientifically measure exposure to ETS and estimates of ..... workplace exposures to ETS The testimony was highly technical, ~ Due ~ lengthy, and delivered in excruciating detail and complexity. to the late hour, the cross-examination of the third witnesswas\"~ postponed until tomorrow morning. The day began with the testimony of Dr. Neal Benowitz,'~ Professor of Medicine, Psychiatry and Pharmacy and Chief, Division~ of Clinical Pharmacology and Experimental Therapeutics, Unlvers~ty ~ of California, San Francisco. Benowitz, who is board certified in~ internal medicine clinical pharmacology, and medical toxicology, ~ , has researched the effects of nicotine on humans for over twenty~ years. More importantly, he has testified against the industry on'~ numerous occasions, although on the topic of addiction and not the~ subject of his presentation this morning. Benowitz argued that measurement of cotinine levels in~'~ human blood, saliva, or urine is the most specific available~ marker of exposure to ETS. He also argued that cotinine is a~ valid quantitative marker of the level of ETS exposure. Benowitz~ began by explaining that the human liver converts nicotine receives from the blood stream into several metabolites, the most~ prominent of which is cotinine. Benowitz argued that data from his laboratory~ experiments indicate that the pharmacokinetics of nicotine and cotinine are similar in smokers and non-smokers, although acknowledged that other scientific papers have disagreed with his~ conclusion. Benowitz then presented a mathematical formula too~ express the relationship between nicotine and cotinine based on~.~ steady state exposure. At least half of Benowitz° paper was defensive in nature'~ -- trying to anticipate the industry's attacks on his findings.~
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Therefore, one section of his paper discussed the fact that~ several foods, including tomatoes, potatoes, cauliflower, and~i black tea, contain small amounts of nicotine. Benowitz argued~! that massive quantities of these substances would have to be~i ingested in order to register significant cotinine levels that~il would affect his theory. Benowitz also anticipated the argument'~i that some portion of a non-smoker's cotinine levels could be.~ attributable to simply being in a room where smoking previously taken place or being near someone with cigarette smokeij~!i on their clothes. After discussing the fact that other chemicals~i in tobacco such as carbon monoxide or cyanide could arguably also~i be used as ETS markers, Benowitz concluded his presentation by<~i stating that, in his opinion, cotinine represented the best?:i currently available marker for ETS exposure. Grossman began his lengthy cross-examination at Ii:20.~ this morning. Although Benowitz was not particularly forceful in~ his direct examination (he has at times a noticeable stutter and~ is obviously uncomfortable with public speaking), he became even© more docile and cooperative on cross-examination. Indeed, the~ vast majority of Benowitz° answers were simply affirmations of~ Grossman's statements of fact. ~.~ After Benowitz agreed with Grossman that the best way to~ determine levels of ETS is by monitors, Benowitz confirmed:'~ Grossman's statement of the significant limitations of using~ markers such as cotinine to determine ETS exposure levels.~ Benowitz agreed with such limitations as the fact that cot~n~ne.~ levels did not account for nicotine exposure from other sources, i~ not all nicotine is breathed in the workplace, there is a~ significant variation in the rate individuals metabolize nicotine, and the timing of urine testing for cotinine levels could affect~h" readings. Perhaps more importantly, each of the limitations[~ listed by Grossman had significant levels of variation, thereby~ further weakening Benowitz' position. Grossman ended this line of~ questioning by having Benowitz again concede that in addition to~ the less effective use of markers, he would have to rely on~ questionnaire data which had its own set of limitations that were~ in addition to those which applied to the use of markers such as~ cotinine • After the lunch break, Grossman questioned for another 25 minutes and then passed the baton to Rupp. Rupp confronted~ Benowitz with a variety of studies cited in his written submissio~ • and challenged Benowitz' reliance on certain aspects of these~ studies. ~. At 2:10 this afternoon, Dinegar of BOMA got up for the.~ expressed purpose of rehabilitating Benowitz. Benowitz conf~rmed:~'~ ~o~,~o 51268 237~
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that no one had ever studied whether smokers are more productive~! when they are smoking, although studies have confirmed, accordin~i to Benowitz, that smokers are generally less productive because-i they are sick more frequently, experience more serious illnesses,..v~I and are more accident prone. Noting that Japan workplaces are~i frequently scented with peppermint in the ventilation system that this seems to increase productivity, Dinegar wondered if.~ Benowitz was aware of any similar study using nicotine, and~i Benowitz replied in the negative. At 2:45 this afternoon, Wayne Ott, an environmental~ii engineer, began reading his brief written submission to th~i audience. Ott received his Ph.D. in environmental engineering~i from Stanford in 1971 and has been a U.S. Public Health Service~! Commissioned Officer assigned to EPA and its Office of Research of~~ Development's Atmospheric Research and Exposure Research~ Laboratory located at Research Triangle Park, North Carolina,~ since 1966. His primary area of research for the EPA is t e~ development and validation of mathematical human exposure models~> to assist that agency in the assessment of personal exposures to~ various indoor and outdoor pollutants. After briefly discussing the historical background of~ model development, Ott described, with great pride, the model he~ referred to as Sequential Cigarette Exposure Model (SCEM). This~3 model is based on the concept that a person in a room with a~ smoker is exposed to a time series of concentrations resultin~ from a succession of cigarettes reflecting the smoking activity~ patterns of the smoker. Using charts of incomprehensible~ • mathematical formulas that would have shamed Einstein, Ott clalme~{ that his SCEM model is very accurate in estimating concentrations~ of pollutants from smoking activities in indoor settings. Ott described in great detail two experiments he cla~ms~ support his contention as to the validity of his model. In one, non-smoking driver of an instrument-filled passenger car drove~ with a smoker who smoked an entire cigarette every fiftee~ minutes. All the windows were up and the air conditioning was on~ high. 0tt then demonstrated actual increases in carbon monoxide<~ and respirable suspended particIe concentrations on a chart~ overlaid with the predictions of his model. He noted with great~ pride the accuracy with which his model had predicted the degree~ of increase. At 3:15, Rupp began what proved to be a difficult an~ slightly contentious cross-examination. Ott repeatedly~.~ interrupted Rupp before Rupp could finish asking his questions andi~ the judge asked Ott on several occasions to wait until Rupp ad.~ finished• It was clear that Ott was extremely suspicious of any~.~ ~o~o 51268 2372~,~" ....
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question, even those which were obviously innocuous, and at time~ he simply refused to acknowledge even the most common-sense~i foundation points Rupp was trying to establish in preparation fo~i more detailed questioning. After some preliminary fencing, Ott agreed that direct,~i measurements of exposure in the field were the best measure of'~i exposure, although Ott defended his beloved model as being helpful~i in understanding and predicting exposures. When Rupp tried toni have Oft acknowledge that a variety of factors (e.u., location the smoker within the room, the size of the room, filters in the!~i! air conditioning, etc.), Oft became obstructive and agitated.<~i Although Rupp's point was eventually made, it was clear that did not or would not understand where Rupp was going with his lineal of questioning. Rupp concluded his examination by letting some of the~ air out of ott's "pride and joy" -- his automobile validatio~-~ experiment. Oft conceded that it is rare for a cigarette smoker© to ride in an automobile with all four windows up. Furthermore,~ ott conceded that if one or more of the windows were down, the~ figures for carbon monoxide dropped dramatically. Rupp also ha~ Oft concede that the test results were affected by the fact that~ the air conditioning was on "recirculate" rather than "ventilate'. Rupp ended his cross-examination with a few questions~ about Repace's 14-year-old study. Oft vigorously defended his~ friend's work despite its age and refused to concede that eithe~ the equipment Repace used in his chamber study or the data~ obtained in that study were outmoded. As Rupp concluded and Ott$~ was preparing to leave the stand, Judge Vitone asked what kind of~ car the test had been conducted in. Ott replied, "It was m~,~ Mazda 626 -- and it smelled awful for months afterwards • Peggy Jenkins began her direct testimony at 4:50 p.m.~ Jenkins has a master's degree in ecology from the University of~ California - Davis and has been the Manager, IAQ Program,i~ California Air Resources Board, Research Division in Sacramento~ for several years. Jenkins used fifty-six 35 mm sl~des deplctlng~ detailed data to illustrate her testimony about a study of T~ reported exposures to ETS in the workplace from an adult activity~ pattern study. The California Adult Activity" ' Pattern Study was telephone survey administered to 1,762 English-speaking, randoml~,~ selected individuals over the age of ii. The questionnaire~9 consisted of a 24-hour recall diary of activities done, locations< visited, and reported exposure to ETS for each activity and~ location. ~"~ ~0~0 51268 237i~
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After spending ten minutes defending the quality of the~i survey and its numerous built-in safeguards Jenkins reported that~ 40 percent of the non-smokers who worked outside the home on their~i diary day reported exposure to ETS at work. A greater percentage-~ii of males (47 percent) than females (30 percent) reported workplace-~ exposures. However, females reported slightly longer durations of.,~ exposure (350 minutes) on average, than did males (313 minutes).~i The average reported exposure duration at work was 5.4 hours, ~i although Jenkins acknowledged that there was a wide variety daily workplace exposure times. Jenkins presented tables of data~i which showed that if smoking did not occur in the workplace, the.~i daily exposure duration for a large percentage of workers would.:2i decrease substantially. Jenkins indicated that this study was<~ designed to provide activity and location data useful in model~ng~<~i population exposures for a variety of pollutants. It appears that~ OSHA is trying to use this study in support of its claim of significant workplace exposure when, in fact, the purpose,.~ according to Jenkins is solely to assist in modeling. At 6:05 p.m., Judge Vitone indicated that the cross-~ examination of Jenkins would be delayed until tomorrow morning.<j~ Ward of R.J. Reynolds indicated that she had approximately one~ hour of questioning and a representative of Washington Technical Information Group indicated that he had approximately thiroty~ minutes of questions. Rupp was uncertain whether he would~ question. The schedule as stated called for OSHA to present three~ additional witnesses tomorrow and Ward suggested an earlier~ starting time in light of the carryover cross-examination of Jenkins. Sherman of the 0SHA Solicitor's Office announced that~ OSHA had postponed one witness from tomorrow to Friday (Philip Morris representatives were rescheduled from Friday to a date in~ December), so tomorrow's session will start at 9:30 a.m. as~ scheduled. This week's hearings are being held in a hearing room at~ the Interstate Commerce Commission. The high ceiling, ornately%~ wood-paneled room is much smaller than the prior two auditoriums..~ It appears that the hearing room is shrinking to accommodate the ever shrinking group of observers. Although this room can~ accommodate slightly over i00, fewer than 50 were in attendance.~ today. One television camera continues to be present but there"~ . was no other sign of media interest in the hearing. After tomorrow morning's cross-examination of Jenkins,.-~ Cathy Hammond, an exposure expert, and William Turner, an IAQ..!~ expert, will testify on behalf of 0SHA. 5~6~ ~7~ ~0946~40
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OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE DATE: September 27, 1994REPORTER: ALLEN R. PURVIS.,,~oi SHOOK, ~Y & BACON'~:~ In a day dominated by industry cross-examination, but steady progress was made on the agenda. Yesterday's last~i witness returned for the conclusion of her cross-examination two of the three originally scheduled witnesses completed their',.~..'~i direct and cross-examination in another day lasting past 6:00 p.m.,:,,.: The afternoon session featured a cross-examination that noticeablyo~..'~ shook the testifying scientist. ward of RJR began a cross-examination of Jenkins at 9:00,~< a.m. The attack focused on Jenkins' questionnaire and pointed numerous subject areas that were omitted or only covered partially~ -- all of which arguably would have affected Jenkins' estimate exposure to ETS. Jenkins admitted that her study only quantaf~ed~ the duration of exposure to ETS and had no data on concentration of ETS exposure. She also agreed that personal~i monitoring would have given more definitive information about~ workplace exposure, although Jenkins, being an advocate questionnaires, obviously did not think monitoring technology was~.,'.'< very good. "It's hard to monitor nicotine levels -- you need~ devices with sufficiently low detection limits." When confronted with a statement by the Program Director~.'~ of the Adult Activity Study to the effect that smoke exposure...c related duration (SERD) presented in the study p r o b ab ly:~.i represented the maximum exposure the participant received during~d~ the day, Jenkins was obviously uncomfortable and replied that Program Director was "not an exposure expert" and all but said hisi~ opinion should be disregarded. Ward pointed out that if a perso recorded in their diary that they were exposed to ETS during their/~ afternoon at the workplace, this could have occurred at the end the afternoon work period but the full work period would recorded as exposure time. Jenkins countered by arguing that smoking occurred at the end of a work period, there was probably..!~ smoking earlier, too. Ward also effectively pointed out that,~ although OSHA was apparently using Jenkins' study as an assessmen~[~ of workplace exposure, Jenkins' study only estimated a duration possible exposure, and Jenkins agreed with this statement.
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After very brief examinations by Chrostowski of~[~i Washington Technical Information Group, Rupp, and Sherman of OSHA,'~i the witness was excused and William Turner was called to the stand~'<~i to begin his direct testimony at 11:15 a.m. Turner is a~i professional engineer with a master's degree in mechanical.-?~i engineering and a specialty in air pollution control For the~~ past 17 years, he has worked in the field of indoor air quality~j and he and his staff have evaluated well over one thousand~<i buildings. Turner spoke on three points of OSHA's proposal. He believes information and training is critical because IAQ problems..i~ are often caused or aggravated by a lack of knowledge understanding on the part of the operators of the building's<~.~ systems. In his experience, Turner frequently encounters HVAC operators who are not aware of the need for maintenance of ~qi critical components of the systems. Similarly, operators~<~i frequently are not aware of or do not understand the limitations of HVAC systems, and this often results in increased occupant discomfort, excessive energy use, and an increased likelihood of gross failure of the equipment to provide adequate air quality.~.~ Turner advocated training for the building manager, the HVAC~¢~ operator, and the occupants concerning IAQ but noted such training~.~ is in its relative infancy. After noting that the EPA has recently developed one and three-day courses concerning IAQ, Turner used the opportunity to strongly imply that his company has in the past and would in the future be available to conduct such~ courses. Turner expressed the belief that dilution ventilation is.~ not an acceptable control strategy with respect to ETS. Based on his experience, he believes that unless the combustion by-products of tobacco smoke are isolated and prevented from entering the general ventilation air stream of the building, non-smokers will be exposed and "this situation is unacceptable." Anticipating the suggestion that alternative ventilation systems could solve the problem, Turner attacked the Filter Air Control Technology System~ developed by Philip Morris and installed in an unnamed performing arts center. Turner dismissed this system as being impractical because it required meticulous engineering application of displacement ventilation, costs more than conventional systems, and requires diligent maintenance. He similarly trashed RJR's-~ plan for ventilation in smoking and non-smoking areas with results of an experiment which was not reported in his paper. The experiment involved measurement of ETS levels in the non-smoking section of a restaurant that had been constructed in accordance~ with RJR's ventilation guidelines and arguably demonstrated elevated ETS levels in the non-smoking area. Turner completed his presentation by testifying that the.~ OSHA compliance program was needed and necessary. He strongly ~0~ 51268 2376
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endorsed the compliance requirement that a building's HVAC system~ be operated correctly to reduce the likelihood of IAQ problems.'~i Turner opined that the OSHA proposal was a logical, flexible program that was consistent with EPA and other organizational~i guidelines ..... At the conclusion of 'i~rner's 30-minute synopsis of-his.~ written submission, Tingle, representing the AFL-CIO, asked Turner~! what percentage of current building owners need to receive additional training on their ventilation systems and Turner replied, "At least fifty percent." In response to another,} question, Turner estimated that it would cost approximately $1,000 ..... in expense and one week in lost productivity to send a "d~signated person" as called for by the proposed rule to receive requisite training. At 11:50, a new face appeared at the podium:<~ for approximately ten minutes of questions for Turner. Matthew,~ Chapiewski of Matric Manufacturing, Inc., challenged Turner's dismissal of filtration and air cleaning systems as being totally..~ inadequate to handle the ETS problem. With a show of disdain,~ Turner explained that the charcoal filters were too costly to.~ install and too costly to maintain since they need to be cleaned so frequently. He claimed that he had never seen any filters successfully in a workplace and suggested that the only place such~i filters could actually work was in a laboratory setting. After the lunch break, Rupp began a lengthy and detailed cross-examination of Turner. After confronting Turner with a brochure from one of his company's training courses and implying~ that Turner wanted a piece of the OSI-I~ "training pie," Nupp moved on to the statement in Turner s submission to the effect that any~: workplace exposure to ETS was "unacceptable." Having already ~ acknowledged that he was not qualified in the health disciplines, Turner scr~bled to defend his statement as meaning such exposure was unacceptable from a health prospective as seen by an engineer. Turner admitted that he was not sure whether even a single molecule of ETS was harmful, but he did agree that some people do not like even trace exposure to ETS for social and psychological reasons. Rupp noted that people's likes and dislikes may be inconsistent with science. Turner conceded that there was virtually no place in the United States where the air did not contain at least trace.N elements of carcinogens. "Even clean, filtered air contains trace~ . amounts." Rupp then confronted Turner with reports on studies in offices where smoking was permitted which indicated benzopyrene levels were about five hundred times lower than Permissible Exposures Limits (PEL) as established by government. Rupp attempted to have Turner concede that benzine.~--? 51268~377
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was no more or less harmful when produced by furniture polish0~ the copy machine than when it was produced by ETS, but Turne~i refused to agree. Turner again criticized filters and air cleaners as method to remove ETS by claiming that a basic principle of hi~! field was that containment and control are the most cost-effective~ methods to remove ETS. In a series of answers that strained Turner's~! credibility, Rupp posed the hypothetical that a worker in a larg~!i office building closed his private office to smoke a cigarette.~i Rupp wondered whether any of that worker's co-workers down the~i hall would be exposed to ETS, and Turner replied that they would~i be Rupp concluded by noting that OSHA's rule estimated that~ it would cost employers $6.84 per maintenance employee for the~&~ contemplated training. Rupp wondered whether Turner would be~ willin~ to offer training to employees for $6.84 and Turner trie~ suggesting that 40~ to downplay this obviously ridiculous figure by ' people could be trained in one day for between $800 and $I,000.<~ Rupp noted that the people who received the training would need know basic chemistry and how air moves around a building, and~ learn about cooling towers and microbial outbreaks. When Turner~ replied, "All of that could be offered in writing," Rupp pounced~ and noted that it already was in writing by various government~ agencies, but people were following the guidelines. After a brief cross-examination by a representative of.~ BOMA, Sherman of OSHA questioned Turner about an example of a s~ck~ building on which he worked in New Hampshire. Unfortunately fo~ Sherman, Turner began his explanation with an apologetic, "The~ problem there wasn't ETS." OSHA's next witness was S. Katharine Hammond, who holds~ a master of science degree in environmental health sciences from~ Harvard and a Ph.D in chemistry from Brandeis University She • • also a Certified Industrial Hygienist. She is currently a~ Associate Professor of Family and Community Medicine at the~ University of Massachusetts Medical Center and Director of the~ Environmental Health Division. Hammond presented her direct~ testimony with enthusiasm and a rapid-fire delivery. She used over fifty 35mm slides complete with supporting formulas, multi-~:~ . colored bar charts, and unique illustrations. On several~ occasions, she made reference to how she "s~umbled" into the ETS~ area approximately 14 years a~o while working on another project. ~0947494
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After describing ETS as a complex substance with over~ 4.000 compounds, including over 40 carcinogens, Hammond proceeded,~i with her advocacy of the use of markers to measure exposure to complex mixtures. In her opinion, the use of markers is appropriate because the active agent in the substance may unknown or the concentration levels may too low to be detectable. ,~ After describing the characteristics of a good marker, Hammond reviewed various suggested ETS markers such as carbon monoxide, .~-~i particular matter, various nitrosamines and nicotine. After discussing why she preferred nicotine as the ETS marker, she described active collection instruments worn by people on theiri~ collars or hung in a specified area. In contrast, passive<~il collectors are simply placed in a certain area. Hammond then proceeded to discuss various studies workplace smoking where sampling instruments had been used. She.~ was obviously proud of the fact that she participated in many of these studies and she concluded that it was pointed out to her that the banning of workplace smoking versus simply restricting it~ dramatically reduces non-smokers' exposure to ETS. She proceeded to review 17 various studies, which she noted were very consistent despite the fact that some dealt with home exposures, others with<~w office exposures, and still others with restaurant exposures. In her opinion, the workplace samples were "off the charts" and~ represented far greater exposure than any of the other situations. Hammond ended her testimony with a spirited attack against the concept of cigarette equivalence, which she claimed is being misused by the tobacco industry. After devising the formula for the calculation of cigarette equivalence, Hammond testified with some degree of constrained outrage about the fact that the industry focuses on nicotine in its calculations of cigarette equivalence when, in fact, if one focuses on other components of ETS which are known to be carcinogens, the cigarette equivalent number is many, many times greater. At 4:50 this afternoon, Furr began a cross-examination.,~ of Hammond that progressively took the wind out of her sails and transformed her from a smiling, confident, quick-delivery witness into a grim-faced, soft-spoken, and hesitating w~tness. Furr~"~ began by reminding Hammond that her initial testimony gratuitously took on the subject of random misclassifications and pointed out the literature indicated that this phenomena.would result in lower figures, thereby suggesting that it was a red herring for the industry to pound on. Furr confronted Hammond with the fact that very recent literature in the field of statistics have said that the traditional thinkin~ that data would be lower because of random classification is now believed to be just the opposite. I09~494 51268 2379
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Furr then pressed Hammond on her selection of nicotine+~ rather than 3-Ethenylpyridine (3-EP) as the best ETS marker. ~'~! While Hammond had dismissed 3-EP as a marker because of one study~i that showed that it did not increase as smoking increased, Furr suggested that recent studies had detected such an increase and.,,~i challenged Hammond to use her common sense -- "How could 3-EP not increase with the number of cigarettes burned?" After Hammond acknowledged that she had not kept up on the literature, Furr advised Hammond that a 1992 study showed 3-EP to be more sensitive than nicotine in terms of detection limits. H~'nmond very ~uietly agreed to look at that data. When Furr challenged some data depicted in a graph from one of Ha~ond's charts and asked that the underlying data be provided to RJR, Hammond balked at sharing her data and:.~2 indignantly said, "I don't give data to just anyone who asks for it -- only to colleagues." In reply, Furr asked whether Hammond was familiar with the ~idelines on sharing data by the National Research Council and Hammond recoiled and meekly replied, "No " Turning to Hammond's claim in her written submission that the methodology of active collection of samples she designed>~ was the most widely used, Furr obtained a confession that no commercial testing labs used her system, nor has it been validated by the Association of ~alytic Chemistr~ or the American Society of Testing Materials. Hammond claimed that she was not interested in what those organizations thought, at which point Furr gleefully advised Hammond that one nicotine testing method had been approved by those organizations -- the one developed by RJR. Continuing his defense of Hammond's attack on the RJR method, Furr pointed to a study which indicated that RJR's passing sampler produced results only one percent higher than average while her passive method was sixteen percent lower. In response~ tO this, Hammond invited attention to RJR's active collector and Furr accepted the challenge by pointing out that RJR's active~ collector used in the study Hammond used for her criticism had been modified by some scientists for various tests and, in fact, three of the six that were actually used produced excellent,~ results. Noting that a portion of Hammond's written submission referred to Repace & 5owry's 1992 paper presenting a model to establish non-smoker's exposure to ETS, Furr embarrassed Hammond by pointing out that she was completely unaware of any scientific criticism in the literature of the Repace & Lowry study. Hammond ~rudgingly admitted that she simply accepted Repace as a valid study because it appeared in a good journal. The fact that was published in a peer-reviewed journal gives it a certain degree ~o~ 51268 2380
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, m of acceptance." To this Furr questioned "Do you really ean..~ that?" Hammond was shocked but agreed with Furr's contention that~i studies in high-quality, peer-reviewed journals are frequently~i withdrawn. Furr then queried Hammond about whether she used the~i same degree of responsibility in relying on the Repace study as...~i she did with the rest of her written submission. Obviously.~i flustered, Hammond admitted that she did not spend much time on the Repace article, but she tried to rebound by arguing that if-~i Repace had been discredited, the OSHA staff would simply disregard~i As Furr gained momentum and Hammond receded in stature,~-ii the subject of cigarette equivalence was next on the agenda. Furr insisted that all of her testimony on this subject was "completely~qi irrelevant to the OSHA rulemaking proceeding we're here today." Hammond seemed stunned for a moment but then offered a~ reason for including it in her testimony -- the tobacco industry~ had used this concept in a very misleading fashion. Hammond.~ agreed with Furr that she was referring to ~JR's use of this~ concept in recent advertising and she claimed that by focusing~ solely on nicotine equivalence, RJR did not advise the public that it was being exposed to many times the larger quantities of<~ carcinogenic materials in terms of cigarette equivalence. When.~ Furr challenged Hammond with the fact that the RJR ad advised~ readers that other components might yield higher cigarett.e~ equivalent ratios, Hammond said, "Yeah, but it was in the small~ print where nobody reads it " When Sherman interjected herself in . an attempt to save Hammond from further questioning, Hammond was able to compose herself and insisted on making another statement~ on the subject. She insisted that it was not just in the RJR ad where such misleading statements occurred, but "it also appears in the scientific papers published by those who work for RJR." Furr~ ended his cross-examination by having Hammond agree that she had... done no study to determine the public's understanding of the RJK~ ad. Having just been visited by the "bad cop," the "good~ cop," Rupp, rose for a brief examination. Among other things,~ Rupp had Hammond concede that it was not just the tobacco industry~ that was concerned that smoker misclassification be accounted for~ in studies -- the government and every responsible scientist working in the area shared that concern because it could affect~ the relative risk ratios. In a longer than usual effort at rehabilitation, Sherman~ of OSHA got some unexpected answers. When presented with the~ hypothetical of a non-smoker standing next to a smoker and another non-smoker standing across the room, Hammond expressed the opinion.~!~ that the one next to the smoker would receive a higher exposure, 5~26~ ~09474~
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at least initially, than the non-smoker standing farther away.~ This seemed to be in contrast to Ott's testimony yesterday and~i prior testimony that ETS mixes instantaneously with all the air a room. Sherman also wondered whether Hammond had ever examined~i nicotine concentrations in smoking lounges, and Hammond returned..,~i to her demeanor as seen on direct testimony and qulckly related,~! how she had recommended that a filter be used to clean the nicotine-saturated air in one smoking lounge and it had been~i successful. Hammond did not seem to understand the frown on~si Sherman's face, as she had not been present during this morning's questioning of Perkins about the effectiveness of filters and air~i cleaners. Before adjourning court at 6:15, Judge.Vitone announced~i that OSHA had made some scheduling changes to ease the schedule~i and take advantage of the fact that Philip Morris' witnesses would~ not be testifying on Friday. Henry Beale, originally scheduled to testify tomorrow, and Philip Morey, originally scheduled to~ testify on September 20, will testify this Friday. Tomorrow's~ line-up of witnesses potentially includes seven witnesses from~ NIOSH as well as two witnesses the National Center for Health Statistics and the National Center for Environmental Health. The~ Association of Flight Attendants' witnesses scheduled for tomorrow~ have been rescheduled for Thursday, and Dinegar of BOMA, who was scheduled to testify on Thursday, has been moved to Friday. Having observed several of OSHA's scientific witnesses be confronted with questioners who are well-prepared on all aspects of the relative science, including the most current~ developments, it is clear that these witnesses were not prepared for what they have encountered. It appears that these witnesses~ expected to present their papers, just as they would do at a~ scientific conference among their friends and peers, and they are~, shocked when their work is challenged, especially in such an effective manner. It remains to be seen, however, whether OSHA~ will give due credit to the many, obviously valid criticisms being'~ heaped upon their witnesses on a daily basis. 10947494 ¢., 51268 23~2
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DATE: OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE September 28, 1994 REPORTER: WENDELL L. ST~E SHOOK, HARDY & B~ON The testimony today was from three govern~t organizations: The National Institute for Occupational Safety ~d Health (NIOSH); the National Center for Health Statistics (NC .~....); and the National Center for Environmental Health (NCEH). T~se three groups, and several other government organizations, ~:ad jointly submitted a written statement to OSHA. The main testi~ny was from NIOSH, which was represented by an 8 member pan~l. Following about 45 minutes of prepared testimony, NIOSH under~nt several hours of cross-examination, primarily by the tobacco industry. The testimony from NCHS and NCEH was short, with little cross-examination. Attendance at the hearing was somewhat higher than earlier this week. Approximately 50- 60 people were in ~<~he audience. NIOSH was represented by Linda Rosenstock, M.D., M.P.H., Director, NIOSH. With her were seven "senior" NIOSH personn.~l: Richard W. Niemeier, Ph.D.; Laurence Do Reed; Richard W. Gorm~n; Michael S. Crandall; Mitchell Singal, M.D.; Mark J. Mende~}l, Ph.D.; and Kyle Steenland, Ph.D. Before beginning her testimony, Dr. Rosenstock noted that she would have to leave immediately following reading the prepared statement. The other individuals on the panel would answer any subsequent questions. Dr. Rosenstock emphasized that NIOSH supported OSH~.~"s position that workers in indoor environments face a signifi~nt risk of material impairment due to poor indoor air quality ..~nd that the provisions in the OSHA notice would significantly reduce that risk. She stated the position of NIOSH that ~he epidemiological literature indicates that ETS is a cause of cancer and "possibly" a cause of heart disease. This s"~me position was put forward by NIOSH in 1991 in its Curr~nt Intelligence Bulletin (CIB) 54 titled "Environmental Toba~o Smoke in the Workplace, Lung Cancer and other Health EffectS." Dr. Rosenstock's testimony discussed some of the more rec~nt epidemiologic literature on ETS and lung cancer and heart disease subsequent to CIB 54. In particular, on the issue of he~rt disease, she mentioned a 1992 review and risk assessment by K~le Steenland (who was with her on the panel), as well as a r~sk assessment published earlier this year by Judson Wells (~ho testified in these proceedings last week). On the issue of l[~ng
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cancer, she particularly emphasized the recent study by Fontha~i~i et al., as well as some other studies relating to occupation~i exposure to ETS. Other topics Dr. Rosenstock addressed were facto~i involved in building related illnesses, sick building syndrome,,~ and the experience of NIOSH in dealing with these issues'~ Operation and design factors related to heating, ventilation a~i air conditioning systems are the major focus in such building~i related problems. Nevertheless, she concluded that ETS ha~i "clearly documented health risks" and is unnecessary to the wo~ process. The best recommendation would be total elimination tobacco smoke in the workplace. A "second best method" would b~i establishing separately ventilated smoking areas. At the conclusion of her prepared~ statement, Dr~ Rosenstock turned over questioning to the panel, got up and lef~ the room. ° © The first cross-examination was by Ray Shaffer, a senator from Nevada who raised questions about whether NIOSH h~ considered data from states with legalized gambling and casinos~ He said that since gaming and smoking are synonymous, the propos ~e~,,, rule would have "devastating effects for the state of Nevada." also raised a question about applicability of the rule fO~ American Indians. Mr. Shaffer was followed by approximately 30 minutes questioning from a representative of the AFL-CIO. A central the~ in this questioning was the importance of OSHA's recommendatio~ .concerning ventilation as a method of resolving buildi~ complaints. NIOSH was questioned about how many of the heal~ hazard evaluations NIOSH has undertaken were directly related ETS. Mark Mendell on the NIOSH panel described this as "important question" because there had been "misinterpretation numbers previously reported by NIOSH." He said that there was information in any NIOSH publications related to health effects ETS. When workers in indoor environments request information fr~ NIOSH, it is because of some problem that the workers don~ understand. If smoking is a problem, it is seen as a problem, a~ workers are not motivated to contact NIOSH. Thus, smoking/E.T~.~ issues don't enter into NIOSH's figures on sources of proble~ investigated in its building evaluations~. Mendell specifical~ challenged a figure, attributed to one of the tobacco compa~ submissions, that only 2% of complaints to NIOSH are related ETS ~'~ The next questioner was Wilfred Rosenbaum (Simon Fras~ University). Mr. Rosenbaum had several questions regardi~ calculations involved in OSHA's risk assessment, as well as OSHA~3 use of underlying data. Elia Sterling (TDS, Ltd.) questioned f.qr 51268 2384
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about 20 minutes on aspects of ventilation and air exchange rate~ recommended by OSHA, as well as concerning potentia~i inconsistencies in the NIOSH written statement and Rosenstock's oral testimony concerning recommendations for smokin~ and nonsmoking areas. Ted Grossman provided the longest questioning of the~i morning, approximately one hour and fifteen minutes. A centra~ theme of Mr. Grossman's questioning related to an unpublished!. Office on Smoking and Health study by Siegal, et al. (1994) which~i although relied on extensively in the NIOSH written statement, wa~-~i not defended by the panel, and no one was prepared to talk abou6~ii it. This paper is titled "The Effects of Separately Ventilate~.i Smoking Lounges on the Health of Smokers ." It reports tha~i separate smoking lounges would expose smokers to high levels o£~i ETS, causing an additional 21,000 deaths per year, far outweighin~i any benefits in reduced nonsmoker deaths related to separate~ smoking and nonsmoking areas• Mr. Grossman also followed a series of questions whic~ undermined the expertise of the NIOSH panel in terms of them • having extensive knowledge on specific ETS epidemiologic stud~e~ and, in particular, lack of knowledge regarding workplace studies~ NIOSH has not conducted any studies of ~his nature on its own. I~ has not recalculated nor done re-analyses of studies reported i~i the literature, but has only read these studies. Neither ha~ NIOSH done any meta-analyses of the ETS workplace studies. Mr. Grossman methodically progressed through a series questions examining several sources of biases and weaknesses the epidemiologic literature on ETS. These weaknesses includ~ various potential confounders (diet, ethnic factors, etc.), recal~ bias and questions about cotinine as a measure of nonsmoker exposure to ETS, particularly in case-control studies. Following the lunch break, Pat Sirridge continued t cross-examination of the NIOSH panel, directing most of hi~ questions to Dr. Kyle Steenland. Mr. Sirridge opened with whlc~<~ series of questions relating to the Helsing, et al., report, ' provided the ETS-associated heart disease relative risk used b~ OSHA in its risk assessment. In response to a question to Dr~ Steenland about whether obesity was a risk factor for heart disease, he replied that there has been some information published~i~. about obesity in terms of people shaped like "apples versus~ • pears." Steenland raised a question: "Do you think that all ETS~ exposed people are apples and all nonexposed people are pears?$ This retort was immediately diffused by Mr. Sirridge who asked the question "Have you done a study on that?" and Steenland replied{ "no." Dr. Steenland acknowledged a variety of problems in the~ Helsing study, including its failure to control for major ris~ 3 51268
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factors, such as diet, its restriction to a limited geographic area and its focus only on whites. The questioning then turned to the issue of whether the.~i heart disease relative risk for ETS "seemed high" relative to that reported for active smoking. Dr. Steenland acknowledged that he.~ had said this himself in a 1992 publication and it. also appeared'~i in NIOSH's policy statement on ETS in 1991 (CIB 54). A substantial amount of questioning focused on Steenland's 1992 risk assessment. Steenland's calculations of. heart disease deaths associated with ETS exposure are<~$~i substantially lower than those proposed by OSHA and this is because the "methodology was completely different" for the two risk assessments. Mr Sirridge queried whether a finding that smoking and heart disease were not associated in China would raise questions about studies of ETS and heart disease in China. Dr. Steenland acknowledged that it would, at which point Mr. Sirridge confronted Dr. Steenland with a review of a book by an individual familiar to Steenland who in fact discussed this specific finding. After acknowledging this, Steenland raised the question "Were any of the ETS studies in China?" and then answered his own question, "Oh, yes, the He study." Mr. Sirridge responded "both He studies." This is an important point because one of these Chinese studies was cited by OSHA as "Positive" on the issue of ETS and heart disease, and the other has been cited in previous testimony at~ these hearings as substantially supporting OSHA's conclusions '~ regarding ETS exposure and heart disease in the workplace. John Rupp opened his cross-examination of the NIOSH panel by referring to a comment in the written statement that smokers have higher absenteeism and other illness related costs, and therefore the proposed OSHA restriction on smoking would~D provide positive economic benefit for employers. Mr. Rupp wanted:~ to know on what basis this statement was made. After substantial hedging and confusion, it was finally acknowledged that NIOSH had no basis, or at least no one knew the basis, for this comment. In fact, on several different issues raised in both the written NIOSH~ submission, as well as the written version of Dr. Rosenstock's oral testimony, the basis for NIOSH's comments was left uncertain. Mr. Rupp's questioning included attempts to identify why~ NIOSH was treating ETS in a manner different from other potential exposures, such as materials emitted from carpet adhesives, ~ formaldehyde from wood, benzene from photocopiers, etc. There was also substantial discussion attempting to identify the basis for disagreement with the 1986 Surgeon General's and National Research Council Reports; NIOSH's positions and understanding of 4 51268 23~
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-n differences between mainstream and sidestream smoke and ETS; ~ ~,~ why NIOSH had not taken into account materials the Tobacco~i Institute (via correspondence with Sam Chilcote) hadprov~ded~i" NIOSH prior to its CIB 54. Mr. Rupp asked several questions about the Siegal, et,~i al., report on which Mr. Grossman had previously questioned the panel. Several members of the NIOSH panel distanced themselves.~i from the Siegal, et al. report, deferring to ~ts authors ~n the i~i Office on Smoking and Health. Following the conclusion of Rupp's questioning, both~i Myron Weinberg (WashTech) 'and Pat Tyson (Constangy, Brooks) were requested by Judge Vitone to submit whatever questions they had in.~i writing. James Dinegar of the Building Owners and Managers..~i Association also had initially requested to cross-examine, but.,~ Judge vitone had previously announced " that Dinegar had~ subsequently agreed to submit his questions in writing. Following a short recess, Mr. Rupp addressed Judge~ Vitone and expressed concern about not having made it clear what~ portion of NIOSH's statement was actually NIOSH's and what came~ from the Office on Smoking and Health. Rupp requested that Judge..~ Vitone make a formal request to the Office on Smoking and Health~ • for someone from that organization to appear at these hearings ~n~ order to answer questions on this issue. Judge Vitone took this~ under advisement. At approximately 4:30 p.m. the testimony began by a~i~ second panel, representing NCHS and NCEH. There were two people~ on the panel, Kurt Maurer and James Pirkle. Kurt Maurer is Deput~ Director of the Division of Health Examination Statistics of th~ National Center for Health Statistics. He has a doctorate in:~ epidemiology from Johns Hopkins University. His testimony~i~ described the National Health and Nutrition Examination Survey (NHANES III). With him was James Pirkle, who is Assistant~ Director for Science of the Division of Environmental Healtb~ Laboratory Sciences of the National Center for Env~ronmenta~ Health, of the Centers for Disease Control. He is a physician who~ also holds a Ph.D. in chemistz-y. Dr. Maurer began with an approximately 20 minute<~ presentation in which he described NHANES as a survey to collect~ data on risk factors, disease incidence and associations of~ various factors with disease. NHANES III is based on a nationa[~ sample of about 30,000 people who have undergone extensive~ physiological measurements as well as questionnaire assessments various characteristics, including smoking habits and exposure to~ ETS. Among the various physiological tests are measurements o£~ cotinine. 5 5~268 2387
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Dr. Pirkle provided testimony "complimentary" to that Dr. Maurer, focusing on the analytical methods for measurement of cotinine in NHANES. He did not provide cotinine data. Essentially, he appeared to be at the hearings only to provide;~! advance information that these cotinine data were being collected and to indicate to OSHA that he hoped to submit the cotinine data':~i during the post-hearing comment period. The cotinine data would.:~ be relevant to the issue of ETS exposure assessment. There was a short period of questioning 1~ l~. Grossman..~i and Mr. Rupp. Mr. Grossman asked whether nicotine levels were~.~ being measured in food. Although Dr. Pirkle is involved in studies~';i of this, he did not want to discuss any specific data at the time..~i Mr. Rupp asked what sort of cotinine analyses would Pirkle providing during the comment period. Dr. Pirkle said he would providing a demographic breakdown of cotinine levels for the U.S. population, according to such major factors as age, race and ethnicity and including some data on workplace categories The hearings concluded at approximately 5:15. The~ schedule for Thursday will open with testimony from the Flight Attendants Association. The American Medical Association and~ Service Employees International Union also are scheduled provide testimony on Thursday. 51268 238~
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OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE DATE• September 29, 1994REPORTER: WENDELL L STONE.~ SHOOK, HARDY & BACON The OSHA hearings continued today with testimony from two unions -- the Association of Flight Attendants (AFA) and Service Employees International Union (SEIU). The American~i Medical Association (AMA) also provided testimony, although~~ questioning was deferred until a later date. The AFA wants the OSHA rule to include airliner cabins. The SEIU wants comprehensive IAQ regulation. The AMA wants the rule to focus on~ ETS to the exclusion of other IAQ factors This was a relatively short day, with the proceedings ending at about 3:15 p.m. Attendance was moderate, beginning at about 40 in the morning, and~.~ decreasing to approximately 20 for the afternoon session. The morning session began with panel testimony by the Association of Flight Attendants. The members of the AFA panel were Christopher Witkowski, Director of Air Safety and Health, and two flight attendants, who presented personal testimonials~ regarding health problems they attributed to airliner cabin air quality The AFA wants OSHA to include airliner cabins as • workplaces in the IAQ regulations. Currently, the Federal,~. Aviation Administration (FAA) has jurisdiction over safety and health matters on airplanes. However, the FAA has traditionally focused on safety factors relating to injury and crash survivability. The AFA believes the FAA has not given adequate attention to health related working conditions in airplanes. ~ Extending the OSHA rule to cover airliner cabins would fill this.~ gap. Although the OSHA panel, particularly the agency's attorney, Susan Sherman, had several questions, there was otherwise no cross-examination of the AFA from the audience. The testimony by the AFA panel did not focus on smoking related issues which is reasonable given that smoking is banned on~ domestic flights. Nevertheless, Ms. Sherman insured that this°~ issue was not forgotten, .by asking a series of questions concerning smoking on international flights, where it is still allowed. Ms. Sherman asked about ventilation rates on international flights as well as health complaint rates on~ international versus domestic flights. The AFA panel did not have information on these issues, but said it might be possible do some comparisons to obtain relevant data. The testimony by the panel .~
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was approximately one hour, with approximately 30 minutes o~ • subsequent questioning by OSHA. The American Medical Association testimony was given Randolph D. Smoak, Jr., who is a physician and member of the AMA's~°! Board of Trustees. He appeared with two other individuals at the~i! testimony table, neither of whom provided any substantiveS! comments. The AMA supports OSHA's proposed rule insofar as it is~l~i directed toward eliminating exposure of workers to ETS. ETS was~:~i described as a carcinogen "in spite of efforts by the tobaccoi~i industry to cloud the issue." ETS is not necessary ~n the~i workplace and elimination can be "instantly achieved" by bannin~i smoking, which was characterized as a "simple, inexpensive and~ direct" solution to IAQ problems. Dr. Smoak's testimony explicitly "singled out" the ETS~ issue for the AMA's support. Although other sources of indoor air problems were acknowledged, the AMA opposed a "comprehensive"~,-, indoor air quality standard, citing issues such as cost, and~ relatively little health benefit, especially compared with th~ thousands of lung cancer and heart disease deaths that would be~ prevented by the elimination of workplace smoking. After Dr. Smoak's fifteen minute oral presentation,~ Judge Vitone sought an estimate of how long Dr. Smoak would be~ questioned. With an estimate of over three hours, Dr. Smoak~ announced that he had to catch an airplane "to go back to take~ care of patients." After several minutes of off the recor~2~ discussion with potential questioners and other interested parties<~ at the bench, Judge Vitone announced that there would not be ample~ time for questioning of the AMA. Dr. Smoak agreed to come bacM~ sometime after October 22 to complete questioning. Later, at the~'~ adjournment of the hearings for the day, Susan Sherman announced that she had spoken with Dr. Smoak, who agreed to come back oni5 October 31 to be questioned. Before dismissing Dr. Smoak, one brief series of~ questions was allowed by Darryl Alexander from the America~ Federation of Teachers. MS. Alexander had several questions~ relating to ventilation, attempting to get some acknowledgemen£1.~ from Dr. Smoak that certain health related conditions such as~ allergies and spread of contagions would be influenced by~ ventilation. Dr Smoak perhaps made some weak acknowledgements . or~i~ this issue, but took care to emphasize that the issue of ETS wa8~ "clear cut." In his view, other aspects of air quality woul~ "cloud the whole issue," which is primarily resolved by dealing~.~ with ETS Following the lunch break, the final testimony for th~$~ day was given by a panel representing a union of service workers the Service Employees International Union. The main SEI~-~ testimony was read by Bill Borwegen, SEIU's Director of Health and['~ 2 51268 2~90
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Safety. Also testifying were two other SEIU members, both of whom~i provided personal testimony on health problems attributed to poor~i indoor air quality. ~i SEIU supports a "comprehensive" indoor air quality rule. :~i The issue of smoking was downplayed. Concerns about ETS "are<~ easily dealt with between employers and employees by either<~ establishing separately ventilated smoking rooms or allowing~! smokers to smoke outside." Policies regarding smoking "almost~i never solve" IAQ problems, because such policies fail to deal with~i the major issues of inadequate ventilation or failure to control~.~ for other contaminant sources. ~ii In addition to setting forth its general support of a~i comprehensive indoor air quality rule, the SEIU presented a~i variety of specific recommendations about dealing with record~ keeping, compliance, and implementation of specific aspects of the~ rule, including training and medical management ~ Mr. Borwegen's testimony seemed to imply that the ETS-~ related aspect of OSHA's proposed rule was moot because most~ workplaces have already adopted smoking policies. The primary<~ cross-examination of the SEIU panel was by Jim Dinegar of the~i~ Building Owners and Managers Association, who attempted to clarify~ the SEIU position on the ETS issue When Mr. Dinegar explicitly~ • ~ asked Mr. Borwegen whether SEIU supported the OSHA rule regarding~ ETS, he responded by saying that the OSHA proposed rule was "very~ reasonable and basically in place," in that most workplaces~ already have such rules.~ Claussen Ely (Covington and Burling) also tried to~ clarify the SEIU position by asking Mr. Borwegen whether he~ believed that current smoking policies required separatelyi~ ventilated and negatively exhausted smoking areas. Mr. Borwegen~ replied that the "bottom line" was that smoking "was not a b~g~ deal " Smoking policies "work." However, every situation ' ~ • "1 S .~ different." Some workplaces have a separate room put aside and~ other places require smokers to go outside. ~ The afternoon session closed with approximately 40~ minutes of questions from OSHA, covering a gambit of issuesi~ relating to description of the union's membership, nature and~ level of membership training, record keeping and other issues. The~ SEIU panel was dismissed at approximately 3:10• i~~ There will be two people testifying on Friday, beginning~ with James Dinegar of the Building Owners and Managersi!i Association, followed by Lance Wallace of the U.S. EPA. ~ 3 ~ 51268 2391
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DATE: OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE September 30, 1994 REPORTER: WENDELL L. STONE SHOOK, HARDY & BACON The OSHA hearings continued today with testimony from James Dinegar of the Building Owners and Managers Association (BOMA) and from Dr. Lance Wallace of the Environmental Protectic%n Agency. Mr Dinegar argued BOMA's position that other than the requirement of eliminating ETS in the workplace, OSHA's proposed rule is unjustified. Dr. Wallace described several indoor air exposure studies he has conducted with the EPA. Despite the small number of witnesses the hearings did not adjourn until nearly 6:00 p.m., primarily because of over four hours of questioning of Dinegar. BOMA represents 15,000 owners and managers of commercial real estate. James Dinegar, BOMA's Vice-President for Government Affairs, opened the hearings with a 30 minute presentation. Citing the example of mishandling the asbestos issue before all the relevant research was available, Mr. Dinegar said that, with the exception of the ETS issue, any general IAQ regulation would be premature and scientifically unjustified. In BOMA's view, IAQ problems are not nearly as widespread as is commonly reported. Mr. Dinegar said that problems with IAQ, although a concern are "nowhere near being an epidemic•" He specifically challenged OSHA's figure that 30% of buildings have IAQ problems. 'We do not%~ see an epidemic of poor IAQ sweeping the nation." In instances where IAQ problems do exist, BOMA recommends focusing on identifying and eliminating the source. ETS is one example of this focus on "source" control. Dinegar also emphasized the role that building tenants play in creating air quality problems, through such activities as failure to dispose of garbage properly and over-watering plants, thereby creating conditions for microbiological growth. To the extent that building owners and managers are responsible for air quality, market forces are sufficient to remedy IAQ problems. Additional regulations are not required. illustrate this point, in what appeared to be a well-practiced theatric, Mr. Dinegar brought from a box under his desk, a series of commercial products and set them one by one on top of the 51268 2392
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51268 2~93 2 ;°.~ table. First', a bottle of Pepsi; then a bottle of diet Pepsi; then a caffeine-free Pepsi; then a caffeine-free diet Pepsi; then a clear Pepsi; then a Jolt Cola, with twice the caffeine and sugar. He did a similar exercise using a variety of different types of deodorants and other products. His argument was that if people want certain products, such as a building with good indoor air, then the market will respond accordingly Earlier this year, BOMA officially resolved to support a federal ban on smoking in the workplace. ETS was characterized a significant individual air contaminant, a leading cause of IAQ complaints and fires, and is "easily identified and eliminated." Ventilation is not the answer to ETS problems, since it dilutes, rather than ~eliminates exposure. Cross-examination began with Elia Sterling from the consulting firm of TDSA Inc During questioning Mr. Dinegar ~ • , acknowledged that "adequate ventilation" is a factor in air quality. Nevertheless, what defines "adequate" would require further research. Following short periods of questioning from three labor groups representing building and construction workers, service workers and government employees, a lengthy cross-examination began by John Rupp. In the morning session, Mr. Rupp questioned Mr. Dinegar for approximately an hour and a half, and another 45 minutes in the afternoon. Much of Mr. Rupp's questioning addressed potential building-related sources of poor IAQ, in an apparent attempt not only to obtain an acknowledgement that "building systems" may be a source of IAQ problems, but to clarify~ how market forces would act in correcting such problems. Although Dinegar acknowledged narrow instances of building-related air quality problems (e.g. Legionnaires' disease), he repeatedly avoided saying that these were "widespread" occurrences. He was well-practiced in repeating his messages that further research is needed to identify the nature prevalence and the sources of air quality problems and that, once identified, those problems should be "attacked at the source." Turning to smoking, Mr. Rupp explored the basis of BOMA's recommendation of a ban, discussing, in turn, the EPA report labeling smoking as a class A carcinogen, ETS-related building complaints and information on fires related to smoking. Although Mr. Dinegar acknowledged that he did not have a detailed understanding of what a 'group A" label means and that BOMA has not undertaken an independent study of the EPA report, building owners and managers are under pressure (e.g. because of liability and insurance issues) to respond to the EPA report. If the government says that ETS is a group A carcinogen, that's sufficient in itself.
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Mr. Rupp attempted to show an inconsistency between BOMA'S position concerning ETS and BOMA°s position concerning benzene. In Mr. Dinegar's view, however, the difference between these two substances is that "benzene isn't brought into buildings by tenants and released into the air at people's leisure. " Mr. Rupp also addressed the issue of data indicating that specific components of ETS are hundreds or thousands of times below the exposure limits set by OSHA. However, in BOMA's view this doesn't change the fact that ETS is classified as a group A carcinogen. Before Mr. Dinegar was dismissed, he was also questioned relatively briefly by representatives of the AFL-CIO and the American Federation of Teachers. Ms. Sherman of OSHA also sought details concerning BOMA's membership and the buildings represented by that membership. At approximately 3:45, Dr. Lance Wallace, an environmental scientist at the U.S. Environmental Protection Agency, finally began his testimony. His testimony mainly dealt with several exposure and building studies. The main projects were Total Exposure Assessment Methodology (TEAM) studies, focusing on measurement of exposure to volatile organic compounds, carbon monoxide or particulates. Although Dr. Wallace's prepared statement was less than six pages, he elaborated in great detail, bringing with him approximately 80 overhead transparencies, containing exposure data and study descriptions on which he spoke extemporaneously for approximately an hour. The TEAM studies involved measurements obtained from personal air monitors, samples of exhaled breath, and this information was correlated with activity data obtained by a personal diary. Among the findings was that indoor air is often the primary source of exposure to airborne contaminants. He testified that ETS exposure is a major source of benzene exposure and respirable particulates. He also testified that airborne nicotine is a useful qualitative index of ETS exposure. Mr. Rupp cross-examined Dr. Wallace for approximately an hour raising a variety of primarily methodological issues and questions about the quality of Dr. Wallace's data. Among the specific issues addressed were ventilation, the size of the rooms where the measurements were taken, the quality and nature of the data on smoking, reliability of recall of exposure information and the influence of other components of air that might influence interpretation of the ETS data. Mr. Rupp also raised a question about whether all of the i~ TEAM studies were done at home. Dr. Wallace said that the 3 5%268
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personal air monitors were also worn by the subjects when they went to work. Therefore, some of the exposure measurements may be relevant to the workplace. Paul Cristowski(sp?) (WashTech) closed the session with a brief series of questions to clarify Dr. Wallace's views and data relating to benzene and ETS. ~he hearings were adjourned at approximately 6:00 p.m. Judge Vittone announced that the hearings would be in recess until Tuesday, October Ii. They will resume in a new location, the main auditorium of the Department of Labor.
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OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE DATE: October II 1994REPORTER: ALLEN R. PURVIS,--'~ SHOOK, HARDY & BACON.~'~ OSHA convened this week's hearing today at its fourth~,'~ii and hopefully final resting place -- the auditorium in the~,-:i Department of Labor building. The three panels of witnesses,,$,,~I criticized OSHA's proposed regulation with statements that ranged<~i from veiled flattery to blunt rejection. Three of the groups!~!! scheduled to testify today failed to show up, so the hearing~:,',' recessed at an early hour. The first panel, representing the Business Council on.<~ Indoor Air (BCIA), was headed by Dr. R. Paul Cammer with the-~ assistance of Frank Gallo, an employee of Union Carbide, and.~ R. Bruce Dickson, an attorney with Paul, Hastings, counsel to<~.~ BCIA. Cammer explained that his group represents approximately companies and several additional trade organizations concerned-,~.~ with indoor air quality. Cammer began by heaping praise on OSHA for having the~~ vision to tackle the IAQ problem and stated that his organ~zat~on.,~ believed that the proposed regulation was a reasonable framework~.'~ in which to solve the IAQ problem. Cammer then turned the>~ microphone over to Dickson, who briefly continued the laudatory~<! comments about OSHA and then proceeded to harshly criticize dozens~-',~ of the regulation' s provisions. Noting that "the indoor ~. environment is the last frontier," Dickson suggested that, unlike~ Davey Crockett, OSHA was constrained by law in what it could do to!~ • solve the problem. Cammer then resumed control of the m~crophone~5 and, after hailing OSHA's "valiant effort" and claiming that iti~ was on "the right track, ~ proceeded to list a multitude of defects~ in the proposed regulation.. Using words and phrases such "vague," "out of date, " "insufficient," "unnecessary, " "too-:~ broad," and "woefully inadequate," Cammer pointed out deficiencies!~ in the proposed regulation and made recommendations for changes.<~' For example, Cammer criticized the absence of a definition "renovation and remodelling" and pointed out that the rearranging of furniture in an office could possibly trigger the~ regulation's provisions even though there was no threat to health.~.~9 Similarly, Cammer noted the lack of flexibility in the carbon~i< dioxide requirements, which could be violated in southern climates.~ ~0~ 51268 239~
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if there happened to be a temperature inversion on a par icular!~ day • ~: With respect to ETS, Cammer, a trained toxicologist,.~i called the regulation's proposed smoking rules a "de facto ban. He noted that in so ruling, OSHA was saying that there was no safe~ii level of exposure to ETS, and he expressed professional difficulty~i understanding such a position from a toxicological viewpoint. expressed the opinion that a zero tolerance level was not a sound~i public policy, and he was very concerned about what would happen~i in the future if OSHA set such a precedent in this regulation. As his testimony closed, Cammer again smiled at the 0SHK'~i panel, returned to his complimentary mode and praised OSHA for~i undertaking this task. As Rupp rose to begin his cross-~i examination, Sherman of OSHA protested to the judge, claiming that:L! 0SHA should be entitled to examine first since these were no longer OSHA's own witnesses. There was no objection from Rupp and~ the other industry examiners, since this is the position our side~ logically prefers -- to have OSHA ask questions without th~[b benefit of the education provided by our questions. Sherman began her examination by virtually demanding~ that the witnesses make specific recommendations to correct the~ problems they perceived with the proposed rule. As he~:i questioning persisted, it began to appear from her tone of voice~ as though she was personally hurt by the criticisms of the~ regulation. The witnesses frequently responded that they had not~~ given a great deal of thought about proposed solutions for th~[~ problems they saw with the proposed regulation but that they would~ do so and provide their recommendations in a post-hearin~ submission. With respect to ETS, Cammer made his position clear: "OSHA has established a definite standard for °materia~"~ health impairment' -- you should stay with that definition and noti~ try to broaden it as you are doing in the proposed regulation." Sherman asked Cammer how the BCIA members handled~ smoking in the workplace. Cammer explained that the members',~ policies varied from complete elimination to control of where~ smoking could take place. Sherman wanted to know whether anM.~ smoking lounges were built in member workplaces similar to thos~ required by OSHA and, if so, how much they cost, but Cammer had noz information on the subject. Sherman repeated this line later i~ the day and it is clear that she urgently wants to get real worl~! data on how much it costs to construct a smoking lounge i~~ accordance with OSHA's proposed regulations. Rupp conducted a short, friendly examination, directin~!~ scientific questions to Cammer and legal questions to Dickson...~ Dickson confirmed that he was unaware of any justification in the'~ ~o~s~6 51268 2397...~
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law or legal cases for a no tolerance standard. Dickson als~i agreed with Rupp's statement that, as a general, rule, OSHA has legal obligation to consider alternatives before banning substance and this means that they should consider ventilation,~i filters and separation of smokers as possible solutions Cammer confirmed that in toxicology the concept of dos~$~!i is critical. "The dose makes the poison" is a common saying i~i the field of toxicology and Cammer confirmed that this concept~i supports his attacks and criticisms on the proposed regulation's~i no tolerance standard for ETS. Dinegar of BOMA provided the only excitement of the daM~ii when he questioned Cammer as to whether RJR was or ever had been member of BCIA, to which Cammer replied, "No." Cammer also state~ that no tobacco company or tobacco-affiliated organization had~ ever been a member of his organization. A~ this point, Dinegar~i claimed that he had a list of BCIA members which included RJR an~ wondered whether RJR was no longer a member. Cammer becam6~ agitated and insisted that neither RJ~ nor any other tobacc~i company has ever been a member of BCIA. Dinegar questioned Gallo, who is responsible fo~ maintenance on Union Carbide's buildings in Connecticut, as to th~ company's smoking policy. Gallo indicated that Union Carbide di~ • not permit smoking in the workplace but tenants in Union Carb~de'~ buildings could allow smoking, although they do not. Dinega~ supported his "ban smoking in the workplace" theory by askin~ Gallo, "How much did that no smoking policy cost Union Carbide? to which Gallo replied, "Nothing." When Dinegar asked whether th~ no smoking policy was working, Gallo replied, "Well, no one smoke~ in the building." As Dinegar walked away from the podium, Dickson aske~ the judge to require Dinegar to show BCIA "the list" of it~ members before it was entered into the record. At this point Furr of Womble Carlyle went to the podium and demanded that RJR~ also be shown the list. Sherman interjected herself into th~ process and suggested that anything could be entered into th~ record, to which Furr responded with astonishment, "How can document that can't be authenticated be entered into evidence -~ it has no evidentiary value." The judge intervened, calme~i~ everyone down and strongly suggested that the parties work out a~ informal solution to the matter. After two additional, very brief cross-examinations~ Mark Ellis of the American Mining Congress took the stand an~ delivered a 20 minute blast to the proposed regulation's smokin~ provisions. Ellis noted that his comments were entirely limited t~ ~0~ 51268 23~8
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the smoking issue and began by reciting how dangerous primary!~i smoking and ETS are. He then quickly shifted gears and attacked~::i OSHA's attempt to enact a regulation when it was unable to. quantify the dose of ETS which would be deemed dangerous. "Given~'~.i the regulatory-uncertainties created by OSHA's position, American Mining Congress endorses voluntary sol~utions to the'%.~i problems of workplace smoking." Sherman seemed eager to examine Ellis but he immediately said that he was not an expert on indoor air quality, thereby..~i eliminating all of Sherman's questions, so she passed examination to Rupp. Rupp briefly established that Ellis was an~! attorney, not an industrial hygienist or other scientist, and that.~i he had not reviewed any of the underlying literature in arriving~{ at any of his opinions. In a two-minute cross-examination, Dinegar suggested!i-.i that employers are currently incurring liability by continuing to~ permit smoking in the workplace after the EPA had ruled ETS to be<[> a group A carcinogen but Ellis declined to offer an opinion on subject and Dinegar sat down. After the lunch break, the panel heard the testimony of~.~ two representatives of The Workplace Health and Safety Council of~ Washington, D.C. The Executive Director of the Council, Jan~ Collins, explained that it is a non-profit organization consisting~ of large and small businesses and trade associations working~.~ together with occupational safety and health experts f or-~ reasonable and effective federal workplace health and safety~ policies. She then turned the microphone over to Sheldon~i~ H. Rabinovitz, a consulting industrial hygienist, who delivered brief statement. Rabinovitz claimed that in his experience most of the indoor air problems he had seen had been cured with changes i,~> which did not significantly affect the chemical composition of the~ air from a toxicological standpoint. He opined that this is clear indication that the major problems were psychological perceptual and for comfort -- not chemical or biological Rabinovitz then accused 0SHA of using data for one substance to~ show a significant risk from exposure to another substance. He<b also claimed that, even if a significant risk is shown for particular substance, such a finding does not justify regulating workplace where that substance is not even found. Finally, and~ most importantly, Rabinovitz claimed that OSHA could not requirements designed for lower exposure to a substance without~ showing a significant risk of material impairment to health that~ would be reduced by that requirement. He vigorously specifically attacked OSHA's proposal to regulate Sick Buildingi~'i Syndrome when, in fact, no ~cause has been established for the-i~ syndrome. I095~926 5~265 ~99
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Collins then began her attack on the practical aspect~i of the proposed regulation. She noted that, as drafted, thgi provisions of the proposed standard would apply to all employers,~..i regardless of who was in control or had access to the building'~i systems. She noted that it may be virtually impossible for a~ employer in a multi-tenant situation to comply with the propose~i standard. Collins protested the possible scenario under proposed regulation where one tenant employer in a building be cited by OSHA if the employee of a contractor hired by building owner or manager to maintain the HVAC system failed use the appropriate personal protective equipment when working o~i the system on another floor of the building in space the employe~i does not even lease. Collins concluded her criticisms b~i suggesting that OSHA needed to substantially modify its curren~ proposal and reissue it for public comment. Sherman began her examination of the panel, whic~ included a physician consultant to the Council, as well as th~ Council's attorney from the Shaw, Pittman law firm. Sherma~ established that Rabinovitz had inspected between 40 and 5~ buildings and found "psychogenic" factors in the majority of th~ buildings to some degree. Sherman again asked whether any of th~ Council's members had constructed smoking lounges in accordanc~ with OSHA'S recommendations but Collins did not have an~ information on that subject or any cost estimates. During a brief cross-examination by Tingle of th'~ AFL-CIO, the physician indicated that he had reviewed all th~ literature on Sick Building Syndrome and was firmly of the opinio~ that there was not enough scientific evidence to support OSHA'.~ proposed regulation of the syndrome, although he acknowledged th~ there was sufficient scientific evidence to justify OSHA'~ regulation of Building Related Illness. The physician made very clear that the Council offered no opinion and had conduct6~ no investigation on the ETS issue. After the representative of the Safe Buildings Allianc~ failed to show up, the judge called Raymond Scannell, Director Research and Special Projects, of the Bakery, Confectionery an~ Tobacco Workers Union (AFL-CIO). Scannell explained that hi~ union represented 125,000 workers, 15,000 of which were tobacc~ workers primarily in cigarette factories. Noting that his ' ~ unlon has always supported safer workplace conditions, includin~ improved IAQ, Scannell expressed his disappointment in OSHA'~ approach to the ETS issue. Noting that the proposed regulatio~ "appears to give a choice to an employer to either ban smoking o~ construct a properly ventilated smoking lounge, Scannell note~ ~--~ ~0~s~ 51268 24OO
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that in light of the cost of constructing smoking lounges, ther~i was really "no choice at all " Scannell expressed the opinion that it made no sense t6~i isolate ETS for special treatment, especially since NIOSH was one! record as saying that the ETS threat in the workplace was minimal:<~!ii He claimed there was no substantial evidence that ETS poses significant risk and was probably no risk in most workplaces.~il~i Scannell noted that OSHA had never applied a zero tolerance limi~i -- not even to asbestos -- and to do so now would probably OSHA to revisit its earlier rulings on substances such formaldehyde. Scannell also noted that a ban was ~ncons~sten~'~i with OSHA's historic policy of using the least drastic solution a problem, and he indicated that proper ventilation was solution with respect to ETS. Scannell concluded by calling this an "insidious rule'~ which sought to prohibit otherwise legal behavior. He expresse~ concern that OSHA would become "a willing agent for social policy~ and end up being the "smoking police." Scannell expressed th~ opinion that OSHA had singled out ETS because of "pol~cy makers'~ lifestyle choices and legal pressure from ASH." He expressed th~~ view that OSHA could modify its rigid approach to ETS withou6~ sacrificing the health of American workers. Sherman began her cross-examination by inquiring about@ the union's workplace smoking policies. This opened the door fo~,~ Scannell to explain that his union had two smoking lounges and liberal break policy to permit employees to use the lounges. noted that the union had received one complaint about workplac~i smoking but this occurred before Montgomery County, Maryland~'.~ instituted workplace smoking regulations and the smoking lounge~" were constructed. There have been no complaints since then.i~. Scannell explained that the union had hired a testing firm, whic~i had determined that there was no measurable drift of smoke fro~ the lounges to the workplace. Scannell ended his cross-examination testimony by notin~ that it was ironic that an OSHA inspector could come to the2 cafeteria of a bakery where his union members worked and cite th~, employer if anyone was smoking in that room, while at the same~ time his union members' exposure to flour dust in the working are~ of the bakery went totally unregulated. The judge ended the day's session by noting that two of the six groups scheduled to appear on Wednesday had eithe~ requested a postponement or cancelled their appearances. The~'i Association of Builders and Contractors asked that its testimonyl~ 5~ ~0~
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be postponed, while appearance. U.S. West Corporation cancelled 10953926 The following two groups were scheduled to testify odayi,,.:i but cancelled their appearances: Institutional and Municipal,~! Parking Congress and NAIOP-Association for Commercial Real Estate. The hearings have fallen into a comfortable routine for the judge, the OSI~ staff and the "regulars." The auditorium at :::i the Department of Labor is by far the most appropriate forum for..~! the hearing. With comfortable theater-style seating for~.~;~i approximately 300, the 30 to 35 members of the audience have~,~i plenty of room to spread out. Media coverage has evaporated, ,~! although press inquiries have been received concerning proposed witnesses. 51268 2402i!~
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OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE DATE: October 13, 1994 REPORTER: ALLEN R. PURVIS~i SHOOK, HARDY BACON",~ i The focus of the testimony shifted away from ETS and the audience heard testimony that ranged from discussions pulsating piles of microbial masses to a spirited defense carpets and rugs. Despite the fact that three scheduled witnesses~,'~i failed to appear, the session extended 45 minutes past Judge~i Vittone's suggested 5:00 p.m. ending time. The first witness this morning was Philip R. Morey,~ Technical Director, IAQ, Clayton Environmental Consultants, Inc.-,.~i Morey received a doctorate in biology from Yale and had a career-~ in college teaching and with NIOSH before becoming a consultant. Morey's forty-five minute direct testimony can be summe~!~,~ up by the single statement: "As a general principle the visible~!~ growth of environmental microorganisms in buildings is not to tolerated." Morey showed a series of slides of microbial growth~ on walls, ceiling tiles and in difficult-to-reach portions of HVACi~ units. He strongly supported OSHA's proposed regulation's~, requirement that humidity in occupied spaces be kept at 60% below because of the vital role water plays in the growth of thesei!i contaminants. While he suggested a few improvements in the rule,~ he generally endorsed the draft regulation's provisions within! respect to microbial contamination. Since this was an OSHA witness, Rupp rather than OSHA~ began the cross-examination. After having Morey discuss relative difficulty of maintaining a 60% relative humidity level~ in naturally ventilated buildings, Rupp tried to have More~ suggest that smoking lounges built in accordance with OSHA's~'~ proposed regulation might encourage mold and fungal growth. Moreyi~'~ was uncertain but ventured an "educated microbial guess" that such~ conditions might be more conducive to microbial contaminant~ growth. At ii:40 a.m., Ann Brockhaus and William Ament Organization Resources Councelors (ORC) began their directi~[ statement. Brockhaus later indicated that she has a masters<~!~ degree in public health from Johns Hopkins University; she read~< most of the statement and answered most of the cross-examination$~ questions. Brockhaus stated her organization's belief that proposed regulation is inadequately supported by scientific as stated in its preamble. She noted that most of ORC's member,,'~,~ 1 51268 2403
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companies already have smoking policies. She also expresse~ concern about the proposed zero threshold for ETS, not because of~!i concern over the subject matter but rather out of concern tha~-'~! 0SHA might be establishing a precedent for future regulations w t~ a zero threshold basis. She urged OSHA to give employers the~i maximum amount of flexibility to solve their IAQ problems withou~<~i government regulation. ORC ended their direct statement stating that not every health safety problem needs to be addresse~i by an OSHA regulation In response to Sherman's first cross-examinational question on behalf of OSHA, Brockhaus revealed that henri organization had conducted an informal poll at one of their~i meetings about smoking policies and this supported her direct~i testimony to the effect that the majority of ORC's members alreadY]i]!i had workplace smoking policies. Sherman seemed very interested in~ the survey and it will be entered into the record. Brockhaus~ noted that very few, if any, of the members had smoking lounges~ built to the proposed OSHA specifications and, with a consisten~$ theme Sherman asked for any data Brockhaus could obtain abour~ , those lounges. When Sherman asked whether there was any interest among~ ORC's member companies about IAQ, Brockhaus responded: "Your~i proposal sure stirred up a lot of interest in it." Brockhaus~ estimated the majority of ORC's member companies have some~ organized program regarding IAQ. When Brockhaus indicated tha~ another meeting of her members would take place during the firs~ week of November, Sherman requested that the membership be polled~ on a number of IAQ questions. In response to questions by Rupp, Brockhaus indicated~'~ that it would be a waste of OSHA's resources to argue over what,> was the appropriate threshold limit for ETS. However, Amen~@~ confirmed Rupp's statement that if OSHA established an ETS PEL i~ would have to abide by legal standards in doing so although OSHA~ apparently thinks it can completely ban ETS without having abide by these same standards. After the lunch break, Arnold VanGelderen and Dr. Ala~ Hedge, representing the Carpet and Rug Institute, launched a~ whining defense of their members' products. Claiming that the~ media had made unsupported but dramatic exaggerations abou~ carpeting as a source of toxic fumes, VanGelderen begged OSHA to~ . remove all of the anecdotal references to carpet as a source o~ indoor air contaminants in the preamble of the proposed~ regulation. VanGelderen claimed there were no scientific studiesi!i which suggested carpeting posed a health hazard and claimed that~ the emissions from carpeting were 200 times lower than most othe~ substances found in offices. 2 51268 2404
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On cross-examination Sherman confronted VanGelderenwat~:' ~'~ an article endorsed by several state attorney generals entitlec~i "Carpets and What You Should Know About Indoor Air Quality VanGelderen claimed that this study used an improper test and was~i based on anecdotal evidence. He stated that "in the old days'~i people would come into a newly carpeted room and equate the smeli~i with something good; however, today people think that any odor necessarily harmful to health. He again blamed the media for problem.~.~ On cross-examination, Dinegar of BOMA wondered why association's installation instructions recommended extr~! ventilation for seventy-two hours after new carpet installation if.~i the fumes were harmless as VanGelderen contended. VanGelderen was~ obviously uncomfortable with the question and suggested that even~.~ though new carpet emits VOCs substantially during the firs~ seventy-two hours after installation, the levels are nevertheless~ not harmful to humans but do contribute to the overall air quallty~ so everyone should do their part to reduce the problem. \ .... The next witness was Jack Halliwell of Halliwell:~ Engineering Associates, Inc. Halliwell is a registered~ professional engineer in thirteen states and his company conducts~ IAQ inspections. He has also taught IAQ at the University of~ Wisconsin. Halliwell stated that he was appearing because the~ proposed regulation would have to be implemented by two groups --~ building managers and companies such as Halliwell's will be asked~ to comply with the rule on behalf of employers• He expressed a~ philosophy that the proposed rule was lacking in the area of~ training and he strongly emphasized that building managers, and~ perhaps even more importantly, architects and building designers,~ be educated on indoor air quality to be used as part of th4"~ solution. The bulk of Halliwell's testimony was spent in vgr~~ specific critical comments on the proposed regulation, w~e~ Dinegar began his cross-examination at 4:15 he said, "Mr.~ Halliwell, you found the key to getting out of here early -- don't~ mention ETS. Since you didn't .mention it, I won't either.~--~ Dinegar then had Halliwell expand on some of the topics he though~!~ should be included in his recommended training program. The last witness of the day was Richard D. Olson,~ • T Project Manager, Regulatory Group, DOW Chemical Corporation heu primary thrust of Olson's comments was directed at the provisions~-" of the regulation which required massive recordkeeping and action.~ to be taken even when there was no evidence of IAQ problems.i~ olson pointed out that most office buildings in the United Etatem~ dO not have IAQ problems and insisted that every Dow building, o~ which there were several hundred, had no such problems. He~ questioned the wisdom of imposing the burdensome paperwork 3 51268 2405
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training requirements on a company which had no problem to solve.~i For ex~a-nple, the proposed regulation requires a w~ritten plan tha~ would include descriptions of the ventilation systems, includ~ng~! schematic drawings. Olson pointed out that I~w had many buildingl~-~-"i which were forty to fifty years old and whose ventilation systems~i had been changed several times over the years. He also pointed~i out that the regulation would limit relative humidity to 60% and..~ this would be impossible to maintain in Dow's greenhouses and?};i aquatic laboratories. He urged OSHA to inject flexibility into}i the proposed regulation. Sherman showed obvious irritation with suggestion that not every employee IAQ complaint should trigger full investigation. Olson suggested that supervisors receivin~[~i complaints from workers are smart enough to know which are trul~ serious and which may simply be caused by stress or other non-~AQ~ factors. Olson finished answering Sherman's questions by saying,~ "Tell us what you want to accomplish but don't tell us how to d~,~ it In his cross-examination, Dinegar tried to make~ something out of the fact that while Dow employees produce and.~ handle many toxic substances, smoking has been banned in company~ workplaces. Olson aclemowledged that his company had implemented smoking cessation program in the early 90s and, although he was~ not privy to management's reasoning for the 1993 smoking ban, h~ presumed it was to encourage people to stop smoking. As the session ended at 5:45, Judge Vittone indicate~.~ that tomorrow's schedule of nine witnesses had already shrunk t six. Furthermore, two of the individuals wishing to testify ar~-~ disabled and have asked to testify by means of speakerphone. The~-~ will be schedule as the first witnesses tomorrow morning. In earlier sessions that ran well past 6:00 p.m. Sherman frequently insinuated that the delay was caused extensive questioning by the tobacco industry la~,ers. The sho~ moved to the other foot today as Sherman's rambling, unfocuse~ questioning added length but not quality to the record. 5126B 2406
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DATE: OSHA HEARING REPORT PRIVILEGED ANDCONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE October 14, 1994 ,i REPORTER : ALLEN R. PURVIS.;~ SHOOK, HARDY & BACOn;! The focus of the hearing returned to ETS as the Tobacc~ii Institute's first witness took the stand and was attacked questions from two anti-smoking group representatives. Gra~ Robertson of Healthy Buildings International and a long-time an~ well-known tobacco industry consultant presented the OSHA pane~ with his suggestions for improving their proposed regulation. unexpectantly gentle cross-examination by Sherman of OSHA left! Robertson with the task of dealing with two ad hominem attacks -~ which he deflected splendidly Before Robertson began his testimony at mid-morning, the. panel heard testimony by a speaker phone to women, each testifyin~ in support of the proposed regulation because of their persona~ circumstances. /~n Gariazzo is chairman of a group known Chemical Sensitivity Disorders Association and currently works ou~ of her home for the Department of Agriculture. She told o~ contracting debilitating illnesses from pollutants in he~2 workplace in Alexandria, Virginia, that has disabled her to th~ point where she can no longer venture out to a mall, restaurant o~ 109S4449
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a movie. She described the tragedy of "chemical sensitivity" and~[~i how her group's members have become impoverished and are ridiculed"-'~i as hypochondriacs. "~ Gariazzo blamed ETS, pesticides (even when used accordance with instructions), carbonless copy paper, Xero~i machines, laser printers, etc. She suggested, without scientific~:i substantiation, that all of these pollutants combined in a synergistic fashion to form a "chemical soup" that was potentially~ • lis deadly to certain workers As Gariazzo continued to substances which should be banned from the workplace including~ strong perfumes, glues and air fresheners, her image involved into;:~ a woman who perceived herself as a victim and had "found a cause~" In response to questions by OSH~'s Kaplan, Gariazzo~ revealed she had seen 11 doctors, had exploratory surgery and sleep study all in an effort to identify her malady• She claimed~2~ building owners conspired to increase ventilation when they kne~.~ inspections of the ventilation systems were to be conducted. The second telephone witness was Susan Watkins, a~!~ attorney with the EPA and a victim of that agency's Waterside Mal~!" sick building in the late 1980s. Watkins described how on fou~2 occasions between 1988 and 1990 she collapsed at work and had t~ be rushed to emergency rooms. Her health progressivel~ 5~6~
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deteriorated and her symptoms included low heart rate, slurred~ speech and muscle weaknesses in her legs. She, too, became~! allergic to perfumes and even the evaporated candle wax at her~i church. Her daughter was in day care at the Waterside Mall and$~ similarly suffered health problems including chronic upperi~ respiratory infections and hair loss. Watkins chronicled her battle against EPA including the filing of a lawsuit against the building's owner which she, too,~ accused of increasing airflow before EPA ventilation tests/.~ • because he was tipped off." Although Watkins supports the proposed OSHA regulation,~ she believes that its voluntary compliance provisions will no~ protect employees. She recommended strengthening the proposec~:~ regulation to include unannounced inspections, civil and crimina~ sanctions against companies and their chief executives, and regulation requiring offices to use non-toxic office supplies suc~ as Borax, vinegar and water as window cleaning fluid, and bakin~ soda At 11:15 Robertson began his statement 1~ indicating was testifying at the request of the Tobacco Institute. indicated that Healthy Buildings International (HBI) agreed tha~i an appropriate OSHA regulation could materially benefit the healt~ ~o~nz 5~26~
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of employees. Having inspected over 1,150 major buildings for.~.-~<'~j indoor air ~uality problems, Robertson stated that in his far too much attention was being paid to ETS and he stated a he repeated several times throughout; the afternoon -- even if ETS~,i~ is eliminated from all buildings, it will have minimal effect sick building syndrome and zero effect on building-relatecl~i illnesses because these are primarily caused by other contaminants.~il that can be cured with adequate ventilation. Robertson contended that OSHA was overstating the ET~ problem because no federal building allows smoking and fewer than~.~ 20% of commercial buildings allow discretionary smoking today. also noted that ventilation rates are far higher today than theyi!~ were back in the 70s and 80s when the studies relied upon by OS~ in its rule-making were conducted. Showing a slide of studies done by seven organizations,.~.~.~ including NIOSH, OSHA and HBI, Robertson noted the consistency i~ the findings -- well over half of IAQ problems were attributed t~ ventilation and microbial contamination constituted another ve~,..'. significant problem. On most of the studies, ETS was only cited!~ as a problem in 2%-5% of the buildings. Robertson used the ;~. to support his repeated conclusion that more attention needed t~ be focused on microbial pollution. ~.0955731
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He noted that there was little data on ETS and building syndrome, but he cited the RJR study which acknowledged no one would believe because of the source. Howeve~ he noted that Haywood and Light of the U.S. Public Health Servi~ had subsequently demonstrated that separation of smokers and no.~ smokers with separate ventilation systems eliminated ETS and t~ ETS was generally exaggerated as a problem. Robertson wondered why there was so much discussion al:~ut ETS when Legionella caus.,~ between 25,000 and 116,000 cases of illnesses each year which described as "huge number in comparison to ETS." Robertson urged OSHA to adopt ASHRE standard 62-1989 a~d frequently stated that the increased ventilation flows provided this standard would allow moderate smoking when coupled wi~ dilution infiltration. Again noting that a 1989 study he conducted of buildings in New York City at the request of R.J. Reynolds w.~,~, criticized because of the funding source, Robertson pointed the consistent findings of extremely low levels of nicotine offices and restaurants allowing smoking. Whereas OSHA has permissible limit of 500 micrograms of nicotine, the average foun'~ in this study was 4.3 to 6.3 micrograms. Robertson testified wi~ obvious glee that his 1989 findings were confirmed in a J~ article in 1993. 5~.26B 109S5731
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Robertson also pointed out that every ETS chemic~i compound occurs naturally in the air. He chose benzene as example and noted that OSHA allowed one part per millionth whil~i his studies found .0025 to .0042 parts per millionth in smokin.~ areas of office buildings which he noted was over one thousan~i times lower than the PEL OSI-~ establish for benzene. Roberts~! noted that if people were concerned over the level of benzenNi created by ETS in the workplace they shouldn't go home becaus~~ there was far more naturally occurring benzene in their home © Robertson noted that there were many options to furth~ reduce all airborne pollutants, including ETS such as improve~ conventional filters, supplemental air cleaners, absorp~io~ filters and improved ventilation. Robertson then attacked OSHA's cost calculations f@ complying with a smoking ban. He noted that while OSI-~ calculate~ zero cost for a ban, EPA acknowledged that it was fair to estima~ that smoking workers would require two 15-minute breaks each d~ during which no work would be performed while they went outside smoke. Robertson noted this 30 minutes constituted 6.25% of th~ work day that would have to be classed as lost productivity a~ . calculated a $48 billion possible loss in productivity. He als~ calculated substantial extra costs in operating elevators an~ opening doors to allow smokers to go outside to smoke.
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Next, Robertson attacked the claimed savings from smoking ban of 21 cents per square foot. Having talked to manM--! office maintenance companies, he asked how much they would reduc~i their prices if they didn't have to empty ashtrays in a buildin and they all replied "zero." Robertson also attacked EPA'~}!~ claimed $5 to $i0 billion savings on housekeeping and maintenanca,~ii that Secretary Browner told Waxman's committee would be realizerS! £n the event of a smoking ban. Much of the maintenance savingff~ were calculated by EPA on the basis that non-smoking offices woul~ be repainted every seven to eight years while smoking office~ii would have to be repainted every four years. Robertson again tol~i the panel that he had consulted with building managemen~)~ executives who scoffed at the idea proposed by EPA. Again, wit~ obvious glee, Robertson pointed out that the EPA "missT£ perpetrated by Browner in February 1994 was acknowledged by th~ EPA because in April 1994 they eliminated the painting savings bu62~ replaced them with identical costs for increased replacement o~" computer keyboards for smokers, more frequent replacement o~ chairs and desks of smokers and replacement of carpets because o~)~ burns by cigarettes. ~obertson remarked that it was a "remarkabl~,~ coincidence" that the same figure, $7 billion, was achieved under~ the recalculation by EPA. At 11:50 this morning, the first of the anti-questioners~ approached the podium. Ann Morrow Donnelly, chairman ofV~rg~n~a~;' "
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Group to Alleviate Smoking in Public, used the podium to make,~! • many speeches" against ETS, the tobacco industry and Robertson.>2} In response to Donnelly's questions about which of the four~i thousand chemicals in ETS would he measure, Robertson repeated~i,,.. earlier testimony and again emphasized that the levels these~i sources created by ETS were one thousand times below PEL "~'~i Robertson told Donnelly "you can go to your home tonight and find~i far higher levels of all these chemicals -- if you're concerned.~ about it don't go home." Responding to a statement by Robertson.~ , characterizing her as wanting to ban cigarettes, Donnelly'~ indicated that her group only wanted to prohibit smoking in~ buildings and tagged on the line "what you said was just a common~2 lie promulgated by the tobacco industry." Claiming she had looked Robertson's company up records at the Virginia Corporation Commission, she claimed she~ found out tha~ he took credit for an IAQ project at John Hopkins.~~..~ University When she called the university, they searched their~ records and said Robertson had cleaned our ventilation ducts."~:: Robertson smiled and then proceeded to blow her away with a~ explanation that the university had his company do IAQ studies 12 separate buildings and when one bad building was identified:~i! there was no commercial service that could correct the problem HBI developed the technology to clean the vents. Robert son noted 51268
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that he no longer supplies remediation services because hefeels,~ that would put him in a conflict of interest position. Donnelly then wanted to know how much money Robertson~i! had received from tobacco interests.. Robertson indicated that he~! welcomed money "from any group" and then declined to discuss client's matters although he offered into evidence a list of " 450 clients. "Call them up -- they're satisfied." with respect to productivity, Donnelly asserted that it was logical that non-smoker's productivity would go down~f,~" :'~ smoking was banned because they wouldn't have their ears clogged,~!~ by tobacco smoke and live in a fear of cancer. To this Robertson~ replied "did EPA employee productivity go up in 1987 when the~ banned smoking --no." As Donnelly left the podium having been admonished by~> the judge for making speeches in her questions, she looked a~!~ Robertson and said "even the devil can quote the scripture~ sometimes." "" Dinegar was the next questioner and his attempt at grandstand play failed miserably. After asking Robertson a feW~}2 preliminary' questions, he asked permission from the court to ti~ht~ a cigarette which he did and inhaled a puff of smoke toward th~ 51268 24~5 10955731
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OSHA panel. Dinegar was trying to make the point that some of the!~i smoke was going affect some of the people on the stage before could be evacuated by the ventilation system. Robertson scoffed at Dinegar and told him that if he went home and cooked a steak on.$~ the grill tonight he would receive many times more carcinogens!~ than "from that little circus show you just put on." Dinegar left~ the podium with his tail between his legs. The next questioner was Mary Petris, apparently an attorney, speaking on behalf of Maryland GASP as well as the<- Association of State and Territorial Health Officers Suggesting that Robertson was a tobacco industry apologist, Petris doggedly pursued a line of questions directed at how much money ~obertson:~ had received from tobacco interests. Robertson acknowledged that he had testified on behalf of TI in front of Congress on six occasions and always acknowledged who he was representing. He also acknowledged a few other industry-related projects but drew the line of discussing his company's financial relationships with~ the Tobacco Institute and this line was supported by the judge on two or three occasions. Having been rebuffed in her attempts to attack Robertson°s credibility because of the money he had received from the industry, Petris finally sat down and the judge:!~! excused the panel for lunch 10955731
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It had been anticipated that OSHA would vigorously!~i attack Robertson,s tobacco industry connections but much to surprise of observers not a single word was said about his prior~i tobacco consultations. Instead, Sherman examined Robertson f two hours and forty-five minutes in a way that seemed generally!~i designed to get Robertson's help in formulating a good IAQ~q! regulation. Robertson explained that he began his business years ago as a result of Philadelphia,s Legionnaires outbreak and"~i the resulting confusion and delay in identifying the source of the~ problem. HBI currently.has offices in Alexandria, Virginia; SanO Diego; Australia; Canada; Spain and the U.K. He employs a staff~ of 16 professionals and several additional support staff. response to Sherman's questions, he told in detail about how hisz company approached a IAQ examxnatxon of a building. Sherman asked for data on costs to retrofit offices withi~! smoking lounges and for a Harris Poll conducted on 15,000 office~i~ workers which rated smoke as the fifth most important problem their offices behind temperature, stuffy air, lighting and noise.~<<~ Robertson laced his conversation with Sherman with numerous rea~ world experiences including the successful accommodations of'~ smokers and non-smokers at a London Hilton Hotel that is so~! successful that the hotel is using it in its advertising.~-<.~ Robertson pounded on the theme that proper ventilation 5126s 2~7~
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filtration could solve any problems and even minimize waiters~i exposure to ETS in the smoking section of restaurants. Sherman asked Robertson how OSHA could develop a PEL fo~i ETS and Robertson acknowledged that it would be difficult. generally recommended a nicotine level as well as a RSP level~;i although he did not know at what point those levels should be Sherman noted that Robertson had claimed that ETS waS far less in 1994 than it was in 1984, and she wondered what would.,i prevent a return to 1984 ETS levels. Robertson said "the court o~ public opinion would never let that happen." With respect to Dinegar's cigarette trick, Shermafi~ suggested "I could smell something" to which Robertson pointed ou~ "odor can be smelled at exquisitely low level" but existence of a~, odor does not make it a hazard. He noted that, in fact, man~' hazardous things in the air cannot be smelled. After Sherman cordially concluded her cross-examinations,, Rupp asked a few questions of Robertson. Nobertson noted tha~ OSHA'S statement in the preamble that natural mechanica~ . ventilation systems were not designed to control the by-product~i of combustion, Robertson said this statement may have been base~! on ancient data because modern systems are designed to handle 51268 241~ ~09557~!
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amount of smoking and, indeed, the ASHRE 62-1989 standards assumes~i a moderate level of smoking. In the middle of Rupp's examination, Dinegar rose to object to the procedure. Apparently, Dinegar felt it was improper for Rupp to be getting a "second bite at the apple," but the judge~?~ii rejectedDinegar's claim and noted that OSHA had been allowed question its own witnesses after they had been cross-examined. Rupp concluded at 5:00 p.m. and one of today's "missing"\~''~ witness finally showed up. Mark Diamond is an attorney is private~;~ practice and editor of The Building Journal. He spoke for 10 minutes in support of the proposed regulation noting that -he represented many plaintiffs in IAQ lawsuits as well as some~,~ defendants. He noted that in the lawsuits the employees never~ knew a problem existed, and the building owners and employers~!~ pointed the finger of responsibility at each other when confronted with a claim. He advocates that OSHA rule because it will eye,one on notice and presumably make his job as a plaintiff°s~ lawyer easier. After i0 minutes of irritating cross-examination by Kaplan of OSHA the judge recessed the hearing until Monday October 24. A CBS news camera was in the courtroom all day but only filmed Robertson°s testimony. USA Today carried a story on;,,,, 5~268 1095S731
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Robertson in Wednesday's edition and CBS has apparently indicat@~ their interest in doing a stor~ on Robertson and his tobac¢~ industry contacts. Ironically, one of the CBS cameraman wa~i wearing a Marlboro hat all day. Today's testimony by Watkins about the IAQ problems EPA's Waterside Mall demonstrated the beautiful irony of th~i circumstance. The agency banned workplace smoking in 1987 an,~ assume that was going to solve all of their IAQ problems~:~i Instead, things got much worse and many employees became ill. © Robertson's presentation was professional, convincin~ and at times humorous. His delightful English accent enhanced th~ content of his testimony. He handled the financial q~aestions the antis very professionally and frequently wondered out loud w~ this would be of interest to the OSHA panel. In response Sherman°s friendly questioning, Robertson appeared helpful an,~ agreed to search his files and provide much additional informatio~ in post-submission. ~.0955731
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DATE: October 24, 1994 OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE SHOOK, HARDY & BACONi~I Although the hearings opened with testimony by Maryland anti-smoking organization which supported the ET~~i provisions in OSHA's proposed rule, the primary focus of today'~ testimony was on the economic argtunents opposing the rule. TwO2 private business and restaurant owners, three associations~ representing the restaurant, hotel and casino industries, university professor who teaches in the hospitality industry are~ and a state chamber of commerce all testified that OSHA's rule~ would effectively ban smoking, thereby producing great econom~c~~ hardship and loss of jobs. Furthermore, the market was alread~ dealing adequately with smoking related issues, primarily through[~ accommodation of smokers and nonsmokers, through such techniqueE!~ as providing separate smoking areas and ventilation. New survey data on economic effects of a smoking ban~ were presented by the National Restaurant Association, whic~!~ testified about a study it commissioned indicating that th~ nation's restaurants would suffer an $18.2 billion loss if OSHA'~ smoking ban were imposed. Potential economic consequences of similarly large magnitude were cited by the San Francisco Hote~.~? Association, which testified that OSHA's rule would lead billions of dollars of lost income stemming from reduced travel the U.S. The San Francisco study was performed by Pric~ Waterhouse, which is scheduled to testify on this survey tomorrow..~ Although eight statements were scheduled today, give~i the relatively straightforward nature of the expected testimon~ and that only small amounts of time had been requested, it wa~ anticipated to be a relatively short day. Nevertheless, primaril~ due to tedious and generally unproductive questioning by OSHA o~ . several of the witnesses, the hearings were not adjourned unti~ nearly 5:45 p.m. The first witness was John O'Hara, president of th~ Maryland Group Against Smokers Pollution (GASP). O'Hara is an.,: employee of the National Security Agency, where he works as a~ engineer and physicist. He urged OSHA to establish a regulation! 1 51268
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that only specifies control of ETS. This aspect of a rule .would~ involve essentially "no cost" and would be "easy to do." His~i prepared comments related mainly to his personal experiences bout how he came to establish Maryland GASP and the experience of the~i National Security Agency in instituting a smoking ban. He also~ili read portions of thirty-five letters he had received providing~i personal testimonials of health problems related to ETS exposure~ in the workplace. OSHA's Sue Sherman asked whether O'Hara had quantitative data on cost savings at the NSA followinginstltut~on~i ......... of its smoke-free policy. He acknowledged that he had nothing<~i quantitative on that issue, but citing the fact that NSA no longer.~i had to clean ashtrays, O'Hara testified that the agency would~{ incur "tremendous savings." The main questioning of O'Hara was by Jeff Furr~ (representing RJR), who focused hi~ questioning on O'Hara's views~ about radiation in ETS, drawing on written materials that had been~.~..~ submitted for the record. On questioning, O'Hara noted that he~ was not a medical doctor, not trained in carcinogenesis, has done no studies on this issue and has not published any original data,~ nor received any grant to study tobacco and radioactivity. ~ Although O'Hara published a 1983 article on radioactivity in~ tobacco smoke, this article has not even once been cited in any other medical journal. During Furr's questioning of O'Hara, Ann Donley~ (Virginia Group to Alleviate Smoking in Public) stood up and~ "registered a protest," noting how Judge Vittone had not allowed~ such questioning of Gray Robertson earlier in the hearings. Judge~ Vittone dismissed Donley, saying that the issue with Robertson involved a completely different area of questioning. Eddy Giel, a private restaurant owner in Charlotte,~ North Carolina, testified that OSHA's proposed rule relating to.~ ETS would in effect "put him out of business Giel's m in~ points, clarified by a short series of questions by Tony Andrade (PM), were that Giel could not afford to build a nonsmoking room~ as specified by the OSHA rule and that instituting smoking breaks~ from work would incur a significant economic cost. Wayne E. Mehl testified on behalf of the Nevada Resort~ Association, which represents approximately forty-five to fiftyo~ . resort casinos/hotels out of approximately 200 in Nevada. He argued that OSHA's attempt to use a "one size fits all approach"~ to the air quality issue doesn't work, because "these rules do not~ fit the resort casino situation." Resort casinos aim to provide"~ clean and hospitable entertainment environments. Furthermore, it~ is necessary for both the practical reason of administering the d games and also by law because of the need for surveillance an 2 51268
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monitoring of the games, for these to be in open areas and for employees to be present. A smoking ban, as would be inevitable under the OSHA rule, would result in a great loss of revenue. A factor influencing this would be competition from Indian casinos, which possibly would not be subject to the rule. In addition, many foreign visitors would simply go to some other country if smoking were banned in U.S. gambling establishments. Edward Gillis, owner of two "Fast Eddie's" billiard establishments in Virginia, testified about his experience in establishing what he believes is a highly effective filtration and ventilation system for his billiard halls. Not only is additional<~"Ci regulation of ETS by OSHA unnecessary, but a smoking ban would.~i "bankrupt many of us in a single year." Ann Donley (from the Virginia anti-smoking organization) in what came to be a pattern of confrontive questions to the witnesses opposing OSHA' position on ETS, challenged Gillis' claim that his filtration system was adequate just because he could not see or smell ETS. His response was that "you can't live in a plastic bag." He said he can't believe that smoking in a well ventilated area with effective filtration, such as he provides in his establishments, can hurt anyone. The National Restaurant Association presented its testimony as a panel of three officials of the organization: James Britt (Director), W.W. "Biff" Naylor (Treasurer) and William P. Fisher, Ph.D. (Executive Vice-President). All have owned or managed restaurants, and thus could testify according to their 'i~ personal experiences. The regulation would "place unnecessary and unreasonable burdens" on the restaurant business and would..~ "clearly cost us jobs." Whether or not smoking is allowed in a restaurant is a "business decision" which is "driven by the demands of the market." The most substantive aspect of the Restaurant .~ Association's testimony related to a new survey reporting that a~ smoking ban would lead to an $18.2 billion per year loss in sales, representing a 6.5% loss of business. One of the arguments that the National Restaurant ~z Association used in support of its position of economic harm is that even if the smoking rule did not effect any particular~ restaurant more than another, it would cause people to eat at home~ more often. As Fisher put it, "one of my biggest goals in life is~l~ to stamp out cooking at home." Mary Ward, representing RJR, briefly questioned the..~ panel. She obtained an acknowledgement that positioning of a~ smoking area next to cooking or kitchen areas, which are highly~ ventilated to the outside, would create a negatively exhausted~ 51268
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situation, eliminating nonsmoking exposure to ETS. James Dinegar (BOMA) also briefly questioned the panel, focusing on the issue of how an exemption for smoking in restaurants might influence restaurants located in high rises owned or managed by BOMA members. Bob Jacobs, from the San Francisco Hotel Association gave a spirited presentation, much of it without notes, reiterating the economic argument, noting that his members were concerned and "shocked" about OSHA's proposal and its major potential effects on tourism. He primarily backed up his economic argument with a study commissioned by the Association to examine the impact of the smoking rule on tourism. Price Waterhouse, which conducted the study, is scheduled to testify tomorrow. Horace Devine is professor and director of the School of Hotel, Restaurant and Tourism Management at the University of Denver. He both teaches and consults concerning the hospitality industry. He testified that the OSHA rule would be both costly and not necessary to address smoking related issues. The primary cost stems from the smoking provisions, in which context he cited the recent study discussed by the National Restaurant Association, to the effect of an $18.2 billion loss if there were a smoking ban. He further argued that "government intrusion is not needed" since the market has provided solutions in its attempts to accommodate smokers and nonsmokers. In Divine's written statement, he pointed out the difference in ventilation conditions in restaurants and hotels as compared with typical homes Myron Weinberg (WashTech) asked a • single question of Divine, namely whether it is a correct interpretation of his written statement that one cannot extrapolate ETS data from one context to another. He replied: "That is correct, that is my contention." The final testimony was offered by the Kentucky Chamber of Commerce, represented by two individuals, John Brazel and Chuck Zimber The Chamber's position is that the OSHA rule is too broad - based and that there is no need for it. It was criticized as being "unrealistically burdensome." The Chamber's testimony did not focus on ETS, but discussed a variety of other aspects in the rule relating to ventilation systems maintenance monitoring and keeping of records. The main comment on ETS was that OSHA's claim that there was no safe level of exposure is not consistent with the concept of dose effects. Not establishing an "allowable . level" of ETS exposure is different from how worker exposures to other substances have typically been treated in terms of permissible exposure limits. Press interest was high throughout most of the day, probably related to the restaurant association's testimony and the survey data on economic consequences of a smoking ban. At the
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start of the hearings at 9:00 a.m , there were six video cameras ..... set up in the rear of the auditorium and in a side aisle As the day progressed, there were as many as ten cmmeras filming the . proceedings. Tony Andrade provided six interviews to the media, five for television and one for radio. The hearings on October 25 will not begin until 10:30 :~'~ a.m. The schedule begins with Michael Hodgson, an OSHA witness "-~ from the University of Connecticut Health Center, who was originally scheduled to testify in September. An extensive series of witnesses, primarily from business associations, are also scheduled to testify. ~'~ 5
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DATE: OSHA HEARING REPORT ~.~ PRIVILEGED AND CONFIDENTIAL ~!;i ATTORNEY/CLIENT PRIVILEGE .~?... October 25, 1994REPORTER: WENDELL L. STONE!~!i SHOOK, H/~RDY & BACON..~} With the exception of an occupational physician~<~ testifying for OSHA, all of the testimony today was in oppositlon,[~i to the proposed rule, and that opposition was specifically~,, directed against the smoking provisions. The American Legion, bowling proprietors association and three witnesses from the© international tourism industry all testified that OSHA's proposal.~ regarding smoking would have adverse economic impacts on their:~ operations. Additional data on the potential impact on,~~ international tourism was provided by Price-Waterhouse, which~,,~ discussed a survey first mentioned yesterday by the San Francisco[~ Hotel Association. A "walk-on" at the end of the day introduced slightly different twist to the economic argument, suggesting that~ shift workers would suffer performance detriments, since under the~%,~ OSHA rule they would not be able to use cigarettes to keep the~ alert while working at night. Yesterday's press interest in these proceedings was no.~[ longer apparent and the tone of the hearings moved back into a more methodical procession through the witnesses. There were several changes in the schedule of ten witnesses slated to appear~i today. Four scheduled witnesses did not appear. Two were simplyoi~<~ "no shows" and two witnesses had requested to reschedule for later date. One witness who had previously been re-scheduled OSHA, but had not been so notified, was allowed to testify today.'~ With the "walk-on," this was a total of eight witnesses. Most of<~. the witnesses had short statements followed by brief periods of.~,~ questioning, with the exception of the Bowling Proprietor' s :~ Association. The hearings, which did not convene until 10:30, an~ hour past the usual starting time, were adjourned at approximately~!~ 4:00 p.m. The hearings opened today with testimony from Michael\~9 Hodgson, M.D., who is an occupational physician at the Universityi,~ of Connecticut, School of Medicine. He was an OSHA witness..~ originally scheduled in September. He supports OSHA's proposed:-~{~ rule overall, taking the position that it would "prevent substantial portion of the preventable diseases related to indoor,'~,,[
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air quality." He reviewed several categories of conditions~i associated with poor indoor air quality, particularly focusing one! building related illnesses and sick building syndrome. He referred to the need to have "exposure control" or "source.,,~ control" in dealing with occupation related diseases. He,~i emphasized the importance of adequate operation, design, maintenance, training and record-keeping concerning "buildlng.~ systems." In his oral presentation, he did not discuss ETSo Rex Tingle (AFL-CIO) asked Dr. Hodgson whether believed that PELs should be used as triggers for remedial action. Dr. Hodge argued that PELs were "inappropriate" for this purpose~ and were "not useful for solving problems in indoor environments." Questioning by OSHA's Sue Sherman focused on the issue ~i of occupational asthma, particularly whether asthma constituted~~ "material impairment." Dr. Hodgson emphasized that although~ asthma varies widely from individual to individual, "some asthma is clearly material impairment." He added, however, that the phrase "material impairment" is a legal term, not a medical one. The A~nerican Legion was represented by the Legion's National Commander, William Detweiler, and two other Leglon~> officials, Steve Robertson and James Hubbard. The Legion opposes OSHA's rule, particularly its smoking provisions, citing the high cost of compliance and the infringement of individual freedom. The Legion opposes segregation of smokers into separate rooms, describing this as a "serious blow to the very heart" of our relationship with our members, which is strongly based on "camarade r ie. " The American Legion's economic impact argument was strengthened during questioning by Ted Grossman (representing RJR). Detweiler acknowledged that Legion members view smoking as a "right." Many post members would quit the Legion, and posts would close, if members were not allowed to smoke. Not only would the~ Legion itself be affected, but the community services associated with these posts would also be lost. The Bowling Proprietors Association of America (BPAA) was represented by Allen Douglas (treasurer) and Rick Bourgeois (a~ former BPAA official). In addition to their BPAA activities, both are commercial bowling center operators. In the prepared statement given by Mr. Douglas, he argued that the proposed OSHA rules did not take into account the unique characteristics of bowling centers, that the industry has already been dealing~ effectively with indoor air quality issues, and that if adopted, the OSHA regulations would have an extremely adverse economic impact on the bowling industry. Unique characteristics of the.~ bowling industry include the open space design, which because of its "sheer size" diffuses potential contaminants in indoor air. 2 51268
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Over 40% of league bowlers are smokers, and league~i bowlers are some of the bowling industry's best custom'ers. Using industry survey data, the BPAA testified that a smoking ban would produce a 30% loss of business. There would be an "immediate, significant and detrimental effect on the economic viability of the bowling industry" by enacting the proposed OSHA rule. Furthermore, the BPAA "does not believe there is a demonstrable, significant risk" that will be "relieved" by the OSHA rule. In any event, the "market already dictates" that indoor air in bowling centers be as attractive and clean as possible, because, ~.~i if not, "our customers would just go somewhere else." However, if~i OSHA adopts this rule, then bowling centers should be exempted, at least allowed a phase-in period to adjust to the economic impact. Sue Sherman spent nearly an hour with a laborious questioning of the BPAA representatives, covering details of the basis for percentages of bowlers who are smokers, data on economics, means used to accommodate smokers and nonsmokers and means used by bowling centers to insure effectiveness of indoor air quality systems. Near the close of Sherman's questioning, she focused on the BPAA's suggestion that it would need a phase-ln period if the rule were adopted. The question was how much time. Mr. Douglas said it would be "a long time, at least five years." ~ In this context, Sherman asked whether it wouldn't "be helpful" for the bowling industry to have a "level playing field." Very strangely and in apparent contradiction of his own testimony, Douglas replied "yes, a level playing field would be helpful," but the OSHA rule is "not the vehicle." He suggested that "it should be done legislatively." The BPAA's position was somewhat clarified under questioning by Tony Andrade, when Mr. Douglas "emphatically" emphasized the Bowling Association's view that OSHA does not need to regulate smoking, because this issue is being handled adequately by voluntary efforts to accommodate both smokers and non-smokers. Jackie Wells testified as the owner of a tourism business called Carolina Meeting & Incentive Group. This business books tours to and from the U.S. and also arranges international tours that businesses use as incentive programs. She provided an ~~ unusually relaxed and well prepared presentation, speaking without notes, knowing exactly what she wanted to say and then saying it. Her message was that the OSHA rule would impinge on freedom of .~ choice and would have an adverse impact on her international ~ travel business. David Karracker, National Account Manager of the Japan Assistance Network, specifically testified about the adverse ..~ economic impact of the proposed smoking rules on Japanese tourism in the U.S. The Japan Assistance Network provides translation, marketing, travel and hotel services for Japanese tourists in the 3 51268 242~
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U.S. The Japanese are very heavy travelers, spend a lot of money..~ when they travel and are therefore a very valuable market Japanese tourism in the United States generates approximately $Ii billion per year. The Japanese are also very heavy smokers and ~i view the convenience of being able to smoke as very important. ~ii Not being allowed to smoke at their hotel, restaurant or other tourist facility would adversely impact Japanese travel decisions to the U.S. Price-Waterhouse was primarily represented by Glen Galfond, who appeared at the hearings to present international tourism survey results on behalf of the San Francisco Association, which testified yesterday. The central point of the survey is that foreign tourism to the U S would be adversely effected by a smoking ban. The survey queried travel agents and~X~i tour operators about expected effects of a smoking ban, with responses indicating that there could be a resulting 6.8% decrease in foreign travel expenditures in the U.S. At the start of Galfond's testimony, Ms. Sherman complained that OSHA had not been given an advance copy of the survey. Galfond gave Sherman a copy and agreed to return to the hearings to answer questions concerning it. Judge Vittone deferred all questioning of Galfond until some unspecified later date. Additional tourism testimony was given by Leila Hunter, who operates Good Times Tours (Florida). Her primary expertise is in foreign tourism, which she believes would be seriously affected by a smoking ban. She said she was simply presenting her views as a business person in this area. The final testimony was offered by a "walk on," Jay Schrand, who described himself as a veteran who also had spent 24 years in the. computer repair business. He has worked as a systems..~ engineer, is pursuing a masters degree in statistics and is also a fire fighter. He expressed concern about the impact of the proposed smoking regulation on shift workers. Shift workers, he ~ testified, have a higher rate of tobacco use, and use coffee more, and the reason for this is to stay alert. Banning smoking would be especially hard on shift workers, because they wouldn't be as alert without cigarette, and would therefore suffer a loss of job performance and promotions. Furthermore, shift workers as a group are likely to be "more seriously dependent on smoking." Representatives of the Casino Association of New Jersey and of the Liberace Foundation, although scheduled, simply did not present themselves at the hearings. Representatives of Ravinia Court Travel and of American Sightseeing, Inc. both had asked to be rescheduled. 4 5126B
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The hearings are set to resume tomorrow at 9:30. The scheduled testimony is from several licensed beverage ~'~i associations, as well as organizations representing various tobacco farmer and producer groups and small businesses.
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DATE: OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE October 26, 1994REPORTER: WENDELL L. STONE SHOOK, HARDY & BACON Many of the scheduled witnesses from the tobacco production and business community did not materialize today. Despite what had appeared to be a heavy schedule, the last testimony was given before lunch, although the judge waited until 2:00 p.m. to adjourn. The witnesses who appeared to testify represented four licensed beverage associations, an association of Kentucky farmers, a tobacco leaf dealer and a small businessman. The testimony was uniformly in opposition to the proposed rule, based on adverse economic effects and unreasonably burdensome mandates. In addition, regulation of smoking constitutes an infringement of freedom of choice and is not needed, because accommodation of smokers and nonsmokers is being adequately handled by private businesses. Representatives of the licensed beverage industry appeared as a panel consisting of Jim Simpson of the National >~,. Licensed Beverage Association; Philip Craig, of the Ohio Licensed Beverage Association; Ron Seng of the Michigan Licensed Beverage Association; and, Penny Laswell of the Licensed Beverage Association of Southwest Ohio. The licensed beverage industry not only opposes the smoking provisions of the rule, but the broader IAQ mandates as well, since they entail additional paperwork, personnel requirements and costs. Mr. Simpson opened by arguing that compliance with the proposed rule was not technologically feasible. Taverns and bars are often located in buildings which physically are too small to provide separately ventilated rooms for smokers and nonsmokers. Mr. Craig hit the economic argument hard with the position that "if this regulation is adopted, our strong belief, and our research indicates, that you would be putting a noose around our necks and killing our industry." If adopted, "people will stop coming into our taverns." They will stay home where they can enjoy acholic beverages and be able to smoke.
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Mr. Craig argued that people choose to go into an adult!~i establishment such as a tavern and they are aware of any risks.~i Customers know that a lot of smoking occurs in these kinds places. The people who choose to work in bars or taverns also~! know that when they take such jobs, these are places where people'i smoke. "It's part of the job." Following a brief reiteration by Mr. Seng of the~¢$i economic loss theme, Ms. Laswell took the microphone to discuss her own experiences as a tavern owner. She said compliance wlth..~i the regulation would be "impossible in my establishment," since i n her tavern was too small to build a separate smoking area.~i Banning smoking is not the answer either, since at least 70% of~i her customers smoke, and this would alienate them and drive them:~i away. During OSHA's questioning of the panel, Ms Sherman~ asked Mr. Craig about the research on economic harm he had~ referenced in his testimony This was a survey conducted durlng.~ 1993-94 by a firm he owns. Based on individuals questioned in various locations in Ohio, he reported that almost 60% of smokers and nonsmokers said a smoking ban was not good public policy Details of the survey are to be submitted for the record. During questioning, Mr. Seng provided additional information regarding economic impact. When he tried to institute "nonsmoking nights" in his bingo halls, this resulted in a~ dramatic decline in business. Even the Aznerican Lung Association,,~ which held bingo games in his facilities, was not in favor of the "nonsmoking night" idea During Mary Ward's (RJR) questioning of the panel, she asked Mr. Simpson to comment on whether the idea of a "self-~ serving, self-cleaning" smoking room would be practical in a~ licensed beverage establishment. Expressing the view that it~ would be "absolutely not feasible" to expect customers to serve.~ and pick up after themselves in such a public establishment, he~ replied: "Have you ever been to an airport bathroom?" In a similar vein, Ms. Ward asked Laswell to comment on the idea, whlchq,> OSHA once suggested, of using "robots" to clean the designated~ smoking rooms that would be required under the proposed OSHA rule. ~ Laswell's response was that "you can't put 40 people over here in a room without knowing what's going." It's necessary to oversee.~ customers, to determine whether customers are being over-served~ with alcohol and to insure orderly behavior. A robot cannot do~ this. Mr. Craig added: "No one wants to buy a drink from R2D2." The next witness was William Sprague, representing the..~ Kentucky Farm Bureau Federation. The Federation represents not~ only tobacco farmers, but other types of farm operations as well. ~ He was opposed to the OSHA regulations because they would restrict~$~ 2 5~268 2432
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tobacco use and would, in turn, reduce the amount of tobacco thato~ would be grown. He testified that tobacco provides $800 million~i in revenue for Kentucky farmers .For the Kentucky economy as a,~: whole, tobacco contributes approximately $2.4 - $3 billion and 15% ~i of the jobs. In addition to the economic argument, Mr. Sprague.~!~i also cited difficulty of enforcement and the personal freedom issue, since such a rule would "go against the grain of the American principle that we can make our own decisions." Rex Foy testified for the K.R. Edwards Leaf Tobacco Company. This company buys tobacco from ~round the world, processes it, dries it and packages and sells at to manufacturers.~,~ who ultimately make it into retail products He argued that the restrictions were intrusive and would require significant time and cost to comply. For his own company, it would take between $750,000 and $I million to be in compliance at his company's major~ locations. For his smaller locations, it wouldn't be possible for them to comply at all Furthermore, his company was already adequately accommodating smokers and nonsmokers. Especially in his business, which deals with the sale of tobacco .products, he said it would be "ludicrous" to be dealing with customers on such a basis and them not allowing them to smoke. The final testimony was by a small businessman, James Ferguson, who owns a polishing and plating business in Ohio. He runs this company with his wife and employs fifteen people. He testified that a smoking ban will harm his business greatly He offered for the record a petition from his employees opposing the~ smoking ban He once tried to ban smoking, but his production and morale went down. During minor questions by OSHA, the impression was~ actually strengthened of a man who was simply trying to run his small business in the best way that he could, without costly regulations from the government which threaten to put him out of business. For example, Debra Janes of OSHA asked: "So you don't think our focus on ETS in regard to the health of workers appropriate?" He replied: "I should be allowed to make my own~,~ decisions and work things out with my employees and staff. If there were a problem with some nonsmoking employee, we would try to accommodate them." At the conclusion of OSHA's questioning of Mr. Ferguson,.~ Judge Vittone, as he often does, had several questions of his own~ for the witness. In what almost seemed to be in order to satisfy~ ' the Judge's curiosity, he asked about the nature of the work that~ Mr. Ferguson did. From this, we learned that Mr. Ferguson electroplated a shovel used for a Rose Garden ground breaking by Barbara Bush at the White House. He also electroplated ornaments"~ for the flag poles which fly at the top of the United Nations~ Building, as well as the bumpers for Johnny Cash's tour bus. 3 S~268~.~433
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Following a lunch break and the determination that none of the more than half dozen remaining scheduled witnesses were present. The Judge said he would wait until 2:00 p.m., and if~ none appeared by then, would leave Sherman had no objections At 2:00 p.m., the proceedings were concluded. There have been off-the-record discussions of the scheduling of Dr. Randolph Smoak's cross-examination. Dr. Smoak, who represented the ~erican Medical Association in testimony on September 29, left the hearings shortly following his prepared~:i statement, citing commitments to his hospital patients. However, <..~ initial brief cross-examination of Dr. Smoak had been allowed from the American Federation of Teachers Dr Smoak was rescheduled to return on October 31 for his cross-examination. The industry:~i recently learned from Judge Vittone that Dr. Smoak now claims to be unavailable until after the first of the year. Dr. Smoak has proposed that Dr. Ronald Davis, who is on the ~MA's Board of-~ Directors, be allowed to appear in his place Dr -Davis, currently director of Michigan's Department of Health, was the former head of the federal government's Office on Smoking and Health Judge Vittone and the OSHA panel have been informed that the tobacco industry considers it unsatisfactory to substitute Dr..~ Davis for Dr Smoak. As a procedural matter, it was Dr Smoak, not Dr. Davis, who had requested to testify, and who in fact did testify and was subjected to initial cross-examination. The rules.~ clearly specify that Dr. Smoak should be made available for cross- examination by other interested parties. Judge Vittone agreed to~ contact Dr Smoak and attempt to obtain a date for him to testify At the conclusion of the hearings, Judge Vittone announced that he had tried to call Dr. Smoak and was to receive a return call from him at 4:00 p.m. Judge Vittone will report back to tobacco industry representatives in the morning on whether a date for Dr. ~ Smoak's cross-examination had been obtained The hearings are set to resume tomorrow morning at 9:30, with the scheduled testimony generally representing a variety of tobacco and business interests. 5~26B 2~3,~
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DATE: OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE October 27, 1994REPORTER: I~NDELL t.. STONE SHOOK, HI~DY & BACON This was another day of testimony opposing the smoking-"2~i related provisions in OSHA's proposed rule. The sequence witnesses was influenced by numerous failures to appear, substitutions and reschedulings, including allowing three farm family witnesses scheduled for tomorrow to testify today. Twelve.,i~ witnesses ended up taking the stand. One represented a private~< aviation business. Six witnesses represented tobacco farming and.~f leaf associations, with headquarters in tobacco states. witnesses testified as individuals from family tobacco farms Today's testimony continues to build a strong record of~,~ how OSHA's proposal to ban smoking is viewed by typical hard-?~ working ;umericans and how it will affect their farms, families, businesses and way of life. The witnesses expressed common themes~ that OSHA's proposed rule is unjustified governmental ~ntrusion and an infringement of democratic freedoms, that ~eclsaons regarding smoking are most effectively and appropriately made by,$~ private businesses and individuals and that a smoking ban would!~ wreck economic havoc, not only on tobacco farmers, dealers and~,~ other tobacco-related businesses, but on the broader community[.~ that is supported by these tobacco farms and businesses. As noted in yesterday's report, the American Medical~ Association's Dr. Randolph Smoak had sought to have Dr. Ronald-~ Davis (former head of the Office on Smoking and Health) appear~!~ instead of Smoak for cross-examination. Judge Vittone opened the~ hearings by stating that he had attained an agreement that Dr Smoak would, in fact, be made available on Monday, October 31, for~ cross-examination. However, Dr. Davis will also be present on~. that day to answer questions. Judge Vittone said the hearings.~ will start at 9:00 a.m. on Monday, in an attempt to accommodate"~ the anticipated extensive cross-examination. The first witness was a private business owner, Michalek, who with her husband owns a small airline service.~ business, Aviation West, in Seattle, Washington. Aviation West?,~ does "everything except flying the planes," including staffin~.[ cargo offices, working ticket counters, loading and unloadln~,$~ 1 5~268 243S
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aircraft, aircraft maintenance and servicing ground equipment. Aviation West employs about I00 people, 40% of whom smoke. The adverse effects of OSHA's proposed rule are evident by examining the effects of a state-level action by the Washington Industrial Safety and Health Administration (WISHA) WISHA is analogous to OSHA on the federal level. It recently established a smoking regulation which is very similar to that proposed by OSHA, in terms of specifying separately ventilated smoking rooms. The new WISHA rule went into effect on October I, 1994. Ms. Michalek testified that the WISHA smoking regulations have had adverse effects on both productivity and morale. Management is now in a position of "being involuntary members of the smoking police." Furthermore, "my employees don't like to be treated like criminals just because they smoke." Ms. Michalek also emphasized the effects of a smoking "we ban on her international business. As she put it, should not force our way of life on visitors from other countries." This is particularly important to her because Aviation West charters aircraft to carry foodstuffs and electronic equipment to the Russian Far East. Many Russian representatives, 99% of whom smoke, have come to Washington state to visit her operation. She has found it "very embarrassing" and "uncomfortable" when delegates meet with her and she cannot allow themto smoke. The Russian reaction is that "democracy is not what we were led to believe " Ms. Michalek left the stand at approximately Ii:00 a.m. and was followed for the remainder of the day by a series of typically five to ten minute statements by tobacco-related associations and farm families, many of which were followed by very little or no questioning. Luke Lambeth, of the Guilford County Farmers,~ Organization (North Carolina), testified as a fourth generation tobacco farmer and as president of the association. He emphasized the simple theme of freedom and individual rights. Yet, "slowly.~ but surely" we are being "run over by our own government." "Our freedom is being taken away from us." The government is picking on tobacco because it is "easy to pick on." Darryl Dunnagan (sp?) spoke on behalf of Rockingham Tobacco Producers and Associates (Reidsville, North Carolina), standing in for Robert Smothers. Mr. Dunnagan grew up on a"~ tobacco farm and has been associated with tobacco production his entire life. He struck the patriotic theme about how "America~ means freedom" and the economic argument that the proposal by OSHA would have a "devastating economic effect" at all levels --..!ii local, state and federal. He closed by a sincere reflect ion that "I just wanted you to know how I feel from the heart." 51268 2436
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A. Winniett Peters testified for Standard Commercial Tobacco Company (North Carolina), a leaf tobacco merchant, which buys, does preliminary processing on, stores and then delivers tobacco products to cigarette manufacturers around the world. He described it as "ridiculous" for a tobacco company to prohibit the use of a product it is trying to sell to a customer, especially when purchases often involve smoking sample cigarettes. The OSHA rule would have "detrimental and harmful effects" on the very nature of our business. Gary Spires testified on behalf of the South Carolina Farm Bureau Federation, taking the place of Harry Bell. Mr. Spires expressed opposition to the rule, citing concern about effects on tobacco farmers in South Carolina. The issue of smoking and nonsmoking employees can be worked out between each other. "Sometimes the solution is worse than the problem." Arnold Hamm, research and technical manager of the Flue Cured Tobacco Cooperative Stabilization Committee, testified on behalf of the Tobacco Growers Information Committee (taking the place of Lisa Eddington) . Although other witnesses at the hearings today had addressed it briefly, Mr. Hamm focused on the EPA report classifying ETS as a class A carcinogen. He noted that the EPA was in litigation over the report and he summarized some of the problems with the scientific basis for" the EPA's conclusion, including how it ignored studies and did not meet statistical significance requirements. The importance of the EPA report for these hearings, Mr. Hamm testified, was that, without it, "we wouldn ' t be here today. " In his view, the EPA "manipulated science" to conform to a "politically correct" position. The final tobacco association testimony was given by Will Clark, of the Western Dark Fired Tobacco Grower's Association (Murray, Kentucky). This association represents about 5,000 growers. This particular variety of tobacco is.of especially high quality and can yield net profits to farmers of $2,000 to $6,000 per acre. There is no alternative crop that would yield this sort of profit to a farmer. Farmers have a great deal of investment .in tobacco growing, yet "with the signing of a pen" OSHA can "change their livelihoods " The final five witnesses were all from tobacco farm families. Two of these witnesses, Patricia Jones and Brenda Isley (both of Reidsville, North Carolina), were already on the schedule. Three witnesses scheduled for tomorrow, Nancy Strader (Ruffin, North Carolina), Lucy Carter and Mrs. John Moore (both of Reidsville, North Carolina), raised their hands just as the Judge was preparing to adjourn and requested that the Judge allow them to testify today. He readily obliged • 3 5~268
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Patricia Jones is a tobacco farmer with her husband and.~$~! has lived and worked on a tobacco farm all of her life. expressed pride in her tobacco farming background, and testified as to her. concern that, if smoking were banned, "tobacco family~.~i farms will disappear." Brenda Isley is a rural letter carrie~, whose husband farms tobacco• She described tobacco as the "foundation on which we built our farm and our family values." Tobacco farming is "our life." "I see this proposal as taking away from my freedom. This is a great burden on my heart." Nancy Strader, a tobacco farmer, described her views as "only those of the average working American•" Farming, which used to be "pleasurable," has now been "bombarded" with regulations She is "amazed at the biased attitudes toward tobacco." "I feel it comes down to a freedom of choice " " Lucy Carter, a bank worker whose husband and son farm~l< tobacco, testified that if tobacco were banned, "the town I live in will be a ghost town " She criticized OSHA's proposal as being • "unfair," because it discriminates against the smoker, "making him.~ feel like an outcast•" The proposal "violates my rights as a citizen of the United States." The hearings closed with testimony from Mrs. John Moore. The production of tobacco has been in her family for many years. She pointed out how it was through tobacco farming that she raised her family, paid the bills and contributed to the economy of the community• The present system of providing separate smoking and nonsmoking areas is working. She is "strongly opposed to a ~[~ smoking ban in a democratic society." If OSHA's smoking rules are~ adopted, many businesses and tobacco farms may have to shut down. The only real excitement of the day occurred at i0:00;~ a.m. when a fire alarm went off, resulting in a 20 minute delay of the proceedings. After determining that this was "an OSHA fire.~ drill," the Judge reluctantly directed everyone to leave the~i building with the rest of the Department of Labor. The hearings adjourned at 2:10 p.m. The Judge will reconvene tomorrow at 9:30 a.m. The schedule for tomorrow appears to be relatively light, especially because three of tomorrow's~ scheduled witnesses already testified today. Most of tomorrow's~~ testimony will come from representatives of several smokers'~.~ rights organizations. What could make this interesting is that~[,~ the schedule also contains Anne Donley, of the Virginia Group to Alleviate Smoking in Public. 51268oi~ 38
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DATE: OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE October 28, 1994 ~PORTER: ~~L L. STONE SHOOK, ~Y & BACON The tone of the hearings took a dramatic turn today with the unexpected appearance of Ronald Motley, a plaintiff's attorney active in smoking and health litigation, including ETS cases. Until today, the testimony this week had been dominated by the views of tobacco growers and associations and small businesses, which opposed OSHA' s proposed rule. The strong focus on individual rights, freedom, and social accommodation had sometimes given the proceedings a personal, and occasionally even a warm, quality. That all changed today when Ron Motley got up, identified his appearance on behalf of the American Medical Association and numerous others and began his cross-examination of a "smokers' rights" group. The hearings had started off on a mild note, with a five minute statement, with no notable cross-examination, by Oliver Parker, a Lorillard employee and tobacco farmer from Greensboro, North Carolina. Following the themes from yesterday Mr Parker opposed the rule, citing its intrusive nature and its adverse economic effects on tobacco jobs, as well as for people in "all walks of life A panel representing the National Smokers Alliance (NSA), a voluntary grass roots organization supporting the rights of smokers, then took their places at the witness table. The NSA was represented by the chairman of its board of advisors, William Althaus; Oscar Coffey, president of the U.S. African American Chamber of Commerce and; Louise Lindblom, director of media and advocacy of the National Urban Coalition. Mr. Althaus gave the opening statement. Speaking • conversationally and without notes, he said the NSA did not represent the tobacco industry but rather represented a million individual members, 20% of whom were nonsmokers, for whom the issue was not whether people should smoke, but "whether we can fairly mee~ the concerns of nonsmokers. he is not a scientist, he nevertheless testified that the scientific "evidence is not adequate" to justify the "very strong" 1 5~266 2
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action proposed by OSHA. 'Furthermore, the wishes and interests nonsmokers are already being recognized. These additional~ measures proposed by OSHA, which do not recognize the rights smokers, are unfair and unnecessary. Mr. Coffey expanded on the theme of how OSHA's proposed~i rule would "restrict the freedom" of smokers in their use of "legal product." Mr. Coffey also addressed the rule's economic~ consequences, with particular reference to testimony earller week on international tourism and restaurants. Furthermore, 21 OSHA's proposal presents a racial issue because the rule wou have a "negative impact" on thousands of small minority owne~ii businesses. The hospitality industry is one of the largest~ii employers of minorities. These would be the "real losers." MS. Lindblom echoed concern about the potential effects of the proposed rule on the hospitality industry, which particularly important in urban areas She also noted its~ divisiveness. Through her work with the National Urban Coalition,~ she has spent her life "bringing people together," but what OSHA~ is proposing "will do just the opposite." In Ms. Sherman°s questioning of the NSA panel, sh~ focused on the group's origins. After determining that it was~ formed in 1993, she wondered how an organization of this nature~ gets a million members in such a short time. Mr. Althaus~ described how people in the tobacco industry, particularly Philip~ Morris, sought to establish a group that could speak out accommodation and on excise taxes. Philip Morris gave the NSA "development grant," but Mr. Althaus does not see this as being~ difficult to understand, because naturally the company would want.~! to support the consumers of its products. In supporting its opposition to the rule, the oral and~ written testimony by the NSA panel cited weaknesses in the~ scientific case against ETS and was particularly critical of th~ • . w~thout~ 1992 EPA report Although Ms Sherman had queried, ' extensive follow-up, as to the panel's basis for challenging th~ EPA report, the questioning on ETS scientific issues intensified~ when Ronald Motley, a Charleston, South Carolina attorney, too~ the podium to cross-examine. Mr. Motley said he was questionin~ on behalf of the American Medical Association, various "ETS~ victims," Virginia and Maryland GASP, the American Heart~ Association and a variety of other organizations. As part of h~i self-introduction, Mr. Motley told the Judge that he represents~ plaintiffs in tobacco litigation, citing at least six specifi~., cases, including ~ and ~. The Judge admonished Motley~f~ to limit his questions to the OSHA rule, not litigation.i~ Nevertheless, Mr. Motley was allowed substantial latitude in his~ questioning. Because so many of his questions were not related 2 5126~
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the OSHA proceedings, it was clear that his primary agenda relate~i tO acquiring information for use in litigation. Mr. Motley's cross-examination was extensive, harsh~i often argumentative and ultimately somewhat repetitive, because h~i posed many of the same or similar questions to several witnesse~i on this panel or who testified later in the day. His cross~!~ examination covered questions about lawyer involvement in science~i particularly whether it is appropriate for lawyers to writ~i scientific opinions and publish them in scientific journals. wanted to know what research on ETS the tobacco companies done. Motley sought acknowledgements about the dissemination o~i scientific information, particularly whether people should b~!i informed about ingredients. Mr. Motley also sought the position! of the witnesses on scientific issues, including whether nicotin~i is a drug, whether tobacco smoking is addictive and whether activ~ smoking causes lung cancer and other diseases. Tobacco compan~ research or marketing activities regarding teenagers, as well smokers' rights membership recruiting for those under 21, er~ also themes in Mr. Morley's questions. In cross-examining the NSA on the issue of its financia1~ underpinnings, Mr. Motley asked of Mr. Althaus: "Isn't it tru~ that the NSA was created by Burson Marstellar?" (Burso~ Marstellar is a public relations firm employed by PM) With th~ Judge's insistence, Mr. Althaus acknowledged that Burso~ Marstellar was involved in the process. Mr. Motley was seated with a group that included Matthe~ Meyers (Coalition on Smoking or Health) and a team of at least dozen presumed attorneys and others, including Richard Dayna~ (TPLP), who observed or assist6d him in his cross-examination. Matthew Meyers also cross-examined the NSA panel.~ Attempting to undermine the witnesses' testimony concernin~ weaknesses in ETS science, he directed similar questions, in turn~ to the panel, obtaining acknowledgements that the witnesses ha~ not read the EPA report, nor the studies on which the EPA repo~ was based, nor other studies. The NSA panel was at the witness table for nearly tw~ and a half hours, so it was nearly noon before the next witness~ Dan Upton, went to the stage. Mr. Upton gives the impression of simple and unassuming man. He came to testify as a tobacco farmer representing himself and neighbors in his Virginia farmi~ community. In a perhaps choppy, but sincere presentation, commented on the issues of "individual rights," "freedom,.~ unnecessary government and positive contributions of tobacco the economy.
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Mr. Motley began to use the s.ame confrontational tactics on Mr. Upton as he had on the NSA witnesses, asking him whether.he knew what additives were, and did he know what tobacco companles added to tobacco. Clearly unproductive with this humble farmer, this period of questioning was mercifully short ..... The afternoon session began with testimony from Oregon Smokers' Rights, a group similar in mission to the NSA, represented by its president, Mark Holan. Mr. Holan testified that ETS presents a "complicated, controversial issue.' OSHA's proposed rule is a "another attempt at backdoor prohibition.• .,~I Most of Mr. Holan's testimony related to the scientific aspects of ETS and health, citing concessions and opinions alternative to OSHA from, for example, publications by the National Research Council, Surgeon General, the Congressional Research Service and~:~i others. After summarizing a range of scientific literature and reaching the conclusion that there was no statistically significant "substantial" evidence supporting ETS and health claims, he proposed that the "answer is not regulation, but accommodation. • Although the questioning of Mr. Holan covered several/'.~ topics, a main theme, begun weakly by Ms. Sherman, but followed up~ in detail by Motley and Meyers, was that Mr. Holan was not well~ informed, and to the extent that he was informed, had misled the OSHA panel in his testimony by taking statements from the literature out of context. Mr. Motley established during cross-examination that Oregon Smokers' Rights was initially formed by R.J. Reynolds. Then, in response to a series of questions, Mr. Holan testified~ that smokers have a right to all of the information, that they have a right to ingredients information, that science should not be manipulated and that he is against the suppression of data. Mr. Holan agrees that studies by tobacco companies should be published, so that individuals can make an informed choice. During Mr. Meyers' highly confrontational cross-~ examination, Mr. Holan took the position that it was not~< "absolutely proven" that active smoking causes lung cancer or any other disease. Mr. Meyers then systematically addressed the~ scientific studies and opinions that Mr Holan had mentioned in his testimony and attempted to demonstrate that these were~ misrepresented. In this process, he obtained numerous~ acknowledgements that Mr. Holan had not presented the full~ conclusions of the publications he cited. The next witness, Sara Mahler, testified for herself and for American Smokers Alliance, a grassroots smokers' rightsi~ organization in New York state. Dr. Mahler is an applied social"~ scientist and a professor in a management school at Hartwick~ College. Much of her testimony focused on a student project where~ 4 51268 2442
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she had students do libra~ research on the ETS issue. Although the students were "shocked" to find out the degree to which the ETS literature was controversial, many students said they weren't goin~ to change what they believed no matter what the literature Dr. Mahler opposes the OSHA rule, which she said would effectively ban smoking and make 50 million smokers law breakers. In her view, this rule was "nibbling away" at individual rights and would be a "step toward a police state." Furthermore, it would "break down families and friendships even further." Repeating a line of questions used with other witnesses, Mr. Motley obtained acknowledgements that it was important that smokers have a right to know the full extent of risks, that .x~ smokers have a right to know additives and a right to know of all the companies' research. The last witness was Anne Donley, executive director of the Virginia Group to Alleviate Smoking in Public (GASP). MS. Donley said she wants "every adult and child to be able to enter the workplace without having to encounter ETS," given that /'~ • smoking is an optional behavior, breathing is not." She dismissed arguments that a smoking ban would have adverse economic effects, such as on restaurant, international tourism and tobacco farming businesses, with the statement that "how many more lives must be sacrificed at the alter of business " Ms Donley read excerpts from letters she had received about health problems, examples of business intimidation or instances showing how'~ accommodation was not working in dealing with smoking and ETS issues. One of her favorite terms is "economic blackmail," ~ meaning that tobacco companies intimidate businesses when, for~ example, a company might establish a smoking policy on the basis of whether or not it offended Philip Morris, or when a tobacco company advertising decision would be based on the content of the magazine. During John Rupp's questioning of Ms. Donley, she~<~ described her training as a librarian• She is not a scientist and has never claimed to be. Mr. Rupp attempted to determine how Ms. Donley gauged the accuracy or validity of the complaints she had received regarding ETS Is it her contention, for example that people can "self-diagnose" whether their medical problems might be related to ETS? Ms. Donley replied by stating that if someone~ . lights up a cigarette in her yard, "my dog would begin to cough,'°~ apparently trying to make the point that in some instances[~,~ scientific and diagnostic trainin~ is not necessary to determine whether something is harmful. Furthermore, it is possible to tell that ETS is harmful from the patterns of being exposed to smoke~'~ and then certain things happening, a personal example being that her eardrums once "exploded" from ETS exposure. 5
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Mr. Motley had only a few questions for Ms. Donley. a very carefully worded question, in which he cautioned her not to~} answer by giving him any specific names, he asked her whether;~,,~! anyone from Philip Morris had talked with her about business.,,~i practices, scientific studies or any record retention or document.i~i destruction policies. Ms. Donley replied "yes.' Motley then asked whether she would be willing to talk to a certain judge.~i about this, at which point Judge Vittone intervened and the!)i questioning of Ms Donley was concluded• The hearings were adjourned at approximately 5:00 p.m. ~,,~ The hearings will resume a~ 9:00 a.m. on Monday, October~,~i 31, beginning with the cross-examination of Dr. Randolph who will be representing the American Medical Association and willo~ be accompanied by Dr. Ronald Davis Othe~ise, the testimony scheduled for Monday will primarily be individual tobacco farmers..'~ and other individuals expressing opposition to OSI~'s proposed,~ rule. 6
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OSHA HEARING REPORT PRIVILEGED ANDCONFIDENTIAL ATTOKNEY/CLIENT PRIVILEGE DATE: October 31, 1994 REPORTER: ALLEN R. PURVIS SHOOK, HARDY & BACON The OSHA hearings got into the spirit of Halloween today with a scary but forgetful panel of experts from the AMA. Dr. Smoak was the ostensible head of the panel because he testified earlier as the AMA designated witness but had eluded industry cross-examination by leaving the hearings early. Today, he returned with one of the biggest anti-tobacco goblins, Dr. Ron Davis at his side to non-answer questions from industry examiners. Davis must have been spooked by the ghost of amnesia because he was unable to recall any details of the many scientific studies on which he was questioned. The day ended on a patriotic note with a private citizen smoker's flag-waving rendition of Ms. Liberty complete with colorful sweatshirt costumes. The only treat of the day was the fact that 13 of the 15 individuals scheduled to testify did not show up, so the session adjourned at 3:30 p.m. Davis accompanied Smoak in his capacity as the AMA Counsel on Scientific Affairs. Dr. Tom Houston of the AMA Preventative Health Division and Mike Zarcy legislative counsel , to AMA, also accompanied Dr. Smoak. In anticipation of extended examination, the judge started today's session 30 minutes early but this proved to be far too little time, especially in light of the evasive responses by the panel. Grossman began his examination by reviewing Smoak's earlier written statement to the effect that since ETS causes cancer and heart disease, banning it from the workplace would be cost-effective. Grossman noted that the AMA did not support the IAQ portions of the OSHA reg "at this time. " Answering for Smoak, Houston admitted that the AMA did no original research but merely did an internal review of the existing peer-reviewed literature. He acknowledged that, despite the endorsement of meta analysis by the AMA as a tool, the AMA undertook no such analysis with respect to ETS at arriving at its opinions. After having Smoak acknowledge that he had not personally reviewed the leading ETS studies, Grossman confronted him with a July 26 statement he made in the press conference in 51268 10955731
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Chicago to the effect that "arguing about the deadly effects of passive smoking is like discussing whether the world is really~'u~ round." Grossman then wondered whether Smoak thinks that all those physicians and scientists who don't believe that ETS causes.. cancer are members of the "flat earth society." Smoak seemed...~i rather uncomfortable and at first tried to suggest that he had been misquoted and, failing this, claimed that he would never lump individuals together in such a group. Grossman then confronted.~i Smoak with an editorial in the September 21 edition of the ~ Qf the National Cancer Institute, which stated that "conventional epidemiological approaches have not fully established that ETS~ causes lung cancer in contrast to active smoking." Davis came riding to Smoak's rescue and answered this and the majority of the~! remaining questions throughout the panel's interrogation. Davis:~i suggested that this comment did not reflect the opinion of agency. Davis simply avoided answering Grossman's question abouto~ whether there were many reputable scientists who did not think the link between ETS and lung cancer had been established • Grossman then asked what was apparently the most~.~ difficult question in the world to answer since it took the panel several minutes of whispered caucusing to arrive at an answer.:,~ Grossman simply wanted a statement to the effect that the question of whether ETS causes lung cancer is a scientific and not a political one. Smoak and Davis each took a shot at a rambling non-answer, to which Grossman replied, "Doctor, what question were you answering?" Davis and the panel obviously attributed great significance to this question, although it was not apparent to observers. In any event, he reluctantly and finally suggested that, "In general terms, that's probably a fair statement." A similar struggle ensued when Grossman tried to have Davis agree to the simple statement that 0SHA should proceed to make its IAQ regulation based on good science. In the middle of his efforts to avoid answering the question, Davis blurted out, "Tobacco wouldn't even be on the market if OSHA existed when tobacco first~ appeared." Davis finally agreed that OSHA should use good scientific evidence in its rule-making, but he could not resist-~ adding, "But there is good evidence on ETS and lung cancer." Grossman then tried to have Davis acknowledge simple'~i propositions about the need for good epidemiological studies to control for confounding factors such as fat intake, beta-carotene and fruit and vegetable consumption. Although each of these has been the subject of a recent peer-reviewed journal article, Davis . claimed not to know the details of the study and refused to answer~ questions based on such factors. When asked about a study showing radon as a cause of lung cancer in non-smokers, Davis proudly refused to discuss the study "because I don't know if they controlled for tobacco smoking." Grossman jumped on this and[~ ~o~o~ 51268
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vould be important for studies on ETS to control fo~ wouldn't it?," to which Davis had no reply. statement that he would be more concerned abou~i ctors in a disease like cervical cancer where known than he would be in a study on lung ~w the cause." £dge began his examination of Davis on the issue disease at 11:15 a.m. He began by having Davi6~i was helpful to the AMA's Committee on Scientifi~i! ~ specialists within the fields of epidemiology ceview the ETS literature. Sirridge then wondered~! aware that OSHA had someone with none of appear before the judge and testify about ETS .dge next moved to the 12 ETS/heart disease studies~ ~ve Davis acknowledge that each was faulty for . .r one or more confounding factors, which Dav~m~ When Sirridge asked whether it was good science~ 2 ~e its opinions about heart disease and ETS on a 0-~ that only controlled for one risk factor (age),<J "I presume you asked OSHA that question earlier,"'~ ~ge replied, "Yeah, and I didn't get an answer then~ his, Davis made the somewhat remarkable statement,~ had enough strong data on ETS and lung cancer to~ e so it really didn't need the heart disease data _dge ended his examination by trying to have Davls~ train facts about attributable risk calculations.~ ~ Davis tO admit that attributable risk was just a~ Dn that could not give any personal data about a>~ .vidual. Davis refused to answer even the simplest:A tried to confuse each one by claiming ignorance~ ~art or on the part of Sirridge about some aspect of~ question. Sirridge finally erupted and told Davis~ [i about attributable risk and ~he ACS statistical~ ~ seem somewhat taken aback and for the first time ' ~ a question straightforwardly. Sirridge ended his<..~ having Davis acknowledge that one should always be~ :ount for confounding factors when assessing any~ study. >ugh the lunch hour had arrived, Judge vittoneo~ ~ted to accommodate the panel, so the examinations~ counsel for the panel whined that the doctors weren,t< their flights, but the judge coerced them into ~han they had originally planned or hoped.
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At 12:05, Rupp began his examination by focusing on th~ AMA's ready acceptance of OSHA's suggestion that there would zero cost for implementation of a workplace smoking ban. Davi~i acknowledged that the AMA had done no study and had gathered n~: data to support this statement and claimed that in fact the statement was speaking "metaphorically." Continuing on this lineal Davis acknowledged that AMA had done no studies ~about state business restrictions on smoking in the workplace to determine effect on productivity and potential cost. Similarly, AMA had no~i studied the health implications of workers going outsidein' col~ or rainy weather on their cigarette break. Davis seemed somewha~!i disgusted by Rupp's suggestion that this could affect the healt~ii of workers, stating somewhat condescendingly, "Mr. Rupp, peopl~i don't get the flu by going outside in cold or rainy weather.~ Rupp directed his next question at Smoak, whose respons~ exemplified the frustration experienced by the examiners all day~ Smoak disputed Rupp's suggestion that smokers would go outside t~l~ smoke and implied they would either not smoke or would find place to smoke inside. For some absurd reason, Smoak brought u~ an airliner as an example, and Rupp pressed him into making th~ ridiculous statements that a smoker might be able to smoke in th~ lavoratory or the galley of the airplane without getting caught~ Judge Vittone saw the frustration level rising and interceded directing Rupp to ask another question. TO this Rupp replied "Your Honor, if the witnesses will admit to the blazingly obvious we will all get to lunch a lot faster." Rupp next questioned Davis on the chemical make-up o~ ETS. While Smoak's statement referred to over four thousan~ different chemical compounds in mainstream smoke, Davis wa~ unwilling to concede that the number identified in ETS was in th@~ neighborhood of twenty. At one point, Davis insisted that all the. chemical compounds found in mainstream smoke were also in ETS bu=~? suggested that some of them were too small to measure. The remainder of Rupp's questioning was met wit~ "selective memory syndrome" on Davis' part. When confronted wit~ particular studies, Davis simply stated that because he was no~ familiar with that study, he refused to agree or disagree wit~ Rupp's propositions. Rupp ended his examination after Davi~ acknowledged that he was familiar with the fact that OSHA ha~ established Permissible Exposure Levels (PELS) for som~ carcinogens that were also found in ETS, but he refused to commen~! on the fact that those PELs were much higher than the levels o~ those chemicals that were found in ETS. Sherman asked a few questions beginning at 1:40, one of which was significant. Referring to safe levels o~ ~o9,z9o9 51268 24-~8
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carcinogenic exposures, Davis replied, "There is no safe level."~ This seems at odds with the fact that OSHA has established~i numerous PELs for carcinogens. The panel was finally released at 1:45 and, after brief luncheon recess, the OSHA panel heard testimony from William.~i Pfeffer, a tobacco farmer from Ripley, Ohio. He noted that his father lost the family farm during the depression because he refused to turn 20-cent-per-bushel corn into 20-dollar-per-gallon whiskey -- "We know prohibition doesn't work." Pfeffer's main$'~i theme was that people such as himself who put up the capital start a business should be able to set the workplace smoking~i rules. He also pointed out that even though big companies in Ohio like Proctor & Gamble have no smoking policies, they are among the~ biggest polluters. He ended his testimony by saying, "God bless~.~ America -- the land of the almost free." The final witness of the day was Birgitt Peterson, a.~ militant smokers' rights advocate, who appeared with her husband~ in matching white sweatshirts with red and blue lettering~ denouncing unfair taxes and supporting smokers rlghts, n rambling, sometimes humorous presentation, Peterson invoked the/~ Constitution and the Bill of Rights in defending her rights as smoker She presented the judge with a petition signed by o er~ nine hundred individuals of Yorkville, Illinois, many of whom were non-smokers, supporting equal rights for smokers After noting that she basically agreed with 90% of the OSHA regulation, she launched an attack on Reich, Kessler and~ Waxman for comparing hardworking American cigarette smokers to drug users. Speaking with a heavy Eastern European accent, she>~ noted that when she came to this country 25 years ago, the~ Constitution did not promise her a job or a house, but it did promise her freedom. She attacked the decision of the "President and Mrs. President" to make the White House smoke-free because~ "the White House does not belong to them." She proudly, and at~ one point tearfully, noted that she is a blood marrow donor and~ while drug users are prohibited from this program, tobacco smokers~ are welcomed, thus proving that smokers are not drug addicts. She obviously spent a lot of time with the dictionary in preparing her statement because she read definitions of the term<~ "public" in defense of her belief that public areas belonged~ equally to smokers and nonsmokers and that smokers' desires should~ be accommodated in such places. She did a similar exercise with~9 the words "equal, "equality," "taxes" and "sin." She claimed that~ her government had slandered her by calling her a sinner and a drug user. 51268 24~ 10962909
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Sherman ventured a few questions but realized she was.~ only providing Peterson more time on her soapl~x. Noting that years ago President Johnson went to Atlanta and took a "Wh~tes~! Only" sign out of a McDonald's restaurant, which had now replaced by a "No Smoking" sign, Peterson proudly marched off stage to her husband who had been videotaping the entire~I proceeding. .~ It was obvious that the AMA was worried that Smoak would!~i be unprepared to respond to industry examiners so they sent Davis,! and Houston as "body guards." Their strategy was very simple quibble and refuse to agree to ~-'~ything. The ~ panel whispered~i tO each other and caucused on almost every answer such that appeared as though one was observing a mafia chief testifying~i before Congress and consulting with his lawyers. In light of~i Davis' and Smoak's inability to recall the details of certain,~ studies and agree to even the simplest concepts, it is very~ difficult to understand how they can be so rock-solid certain,~ about their conclusions regarding ETS. Tomorrow's witness list includes a number of~ individuals, as well as representatives of VFW, National Coalitior[~ for Homeless Veterans and the National Vietn~,'~ Veterans Coalition.2!~ The hearings will resume at 9:30 a.m. ~? 51268 2~50~ 10962909
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DATE: OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE November,,, 1994 REPORTER: WENDELL L. SHOOK, Hi~RDY & BACON~$~. This was a quiet day at the hearings, consisting o~ testimony opposing OSHA's proposed rule from six small business~ owners, two veterans groups, a representative of a smokers' rights~ group, an individual employed in the tobacco industry and a "wal~!~ on" who described an air cleaning invention he hoped to market. The hearings opened with testimony from L. Susan Allsop,<j~ representing the United Smokers Association. Ms. Allsop has a[,~ degree in engineering and a masters degree in sociology. Early in~ her engineering career she had faced sexual discrimination.~ Later, when she moved into the area of sociology, she worked with~ under privileged groups, including blacks and hispanics and saw~ minority discrimination in that context In the late 1980s, s e~ became involved in smokers' rights She testified that smokers~ are now facing the same discrimination she has seen with women,~ blacks, hispanics and other minorities. For example, there can be~ employment discrimination, in which smokers "are being denied~ their rights" to jobs just because they smoke. The Veterans of Foreign Wars (VFW), with 2.2 milliono~ members, was represented by two officers, John Dodge and Jim~ Naughton. Mr. Dodge opened by pointing out that VFW posts have~ "implemented many of your guidelines already, such as ~ncreasang~ ventilation and installing filtration devices to deal w~th%o smoking. These were "done voluntarily." Mr. Dodge discussed the~:~ high percentage of smokers among VFW members and emphasized~ accommodation as the "only answer." Mr. Naughton argued that~ OSHA's rule banning smoking would make it difficult to offer.~ facilities to the community for recreation and would drive post"~ members away because many members would not come to a nonsmoking~: ' facility. Both Dodge and Naughton stressed the "rights" issue~ from the perspective of having spent their lives in the military~°~ in defense of individual freedoms. The next witness was a small business owner, Steven~ Dorobiala, who is president of Empire State Exterminating Company,..~
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in Buffalo, New York. Mr. Dorobiala has an extensive backgroun~i in the pest control business, teaches a number of college entomology courses, is very active in professional organizations~! relating to pest control and has specifically consulted on the~i issue of negatively pressurized rooms, as these might be used vapor containment. Mr Dorobiala discussed the logistical p oblems in~i "decontaminating" a room where smoking has occurred, the effectsi!~i of a smoking ban on employee morale, the cost of building~i separately ventilated smoking rooms and the fact that movement air into a negatively exhausted room can actually bring i~i contaminants into that room. He argued that people have the~i " n ^" "creativity to bring their own "unique solutio ~ to the issue of~{ smoking in the workplace. "Governmental and regulatory~ " " which at on~ intrusion" will have an adverse economic impact, point he described as being potentially "devastating." Faye Everhart, an RJR employee from Winston-Salem, North<~ Carolina, gave a brief statement, in which shecr~tlcazed ....... smoklngT,~ and health related statistics, expressed the "common courtesy"~ theme and defended the "right of someone to smoke." Norman Dresser is vice president of the Dresco Belting~ Company, a small family owned business in East Weymouth, Mass.~ Dresco makes various sorts of belts used ~n manufactur~ng~ processes. Mr. Dresser's testimony attacked excessiv~ governmental spending in general, with the OSHA proposed rule~ being one aspect this. He argued that "millions of people will~ have their lives ruined" if the government doesn't bring it~5 spending under control. The government "can't provide a risk free~ environment, but can go broke trying to do so." Although Mr2 Dresser did not address scientific issues in detail, he commented~. that OSHA's proposal was based on data with "marginal" scientifio~ validity. A smoking ban would have a negative impact on hi~f~ business and on the productivity of his employees. During cross-examination, Ms Sherman probed Mr . Dresser's view on the issue of "marginal" scientific evidence. said he was "not a scientist," but has ~ read of views whic~ indicate that there are "scientists on both sides" of the ETS andi~ health issue, and it is therefore "controversial." Ms. Sherman~ queried whether this meant that the government shouldn't regulat~!~! if there is "controversy." In Dresser's view, the government ha~ to weigh the costs against the benefits. Richard Fitzpatrick, as its executive director,i~ testified on behalf of the National Coalition for Homeless~ Veterans. The Coalition represents more than one hundredthS. community-based organizations that serve the one-third of theo homeless who are also veterans. He testified that the proposed~2~ 2 51268 2452
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rule would have a "dramatic effect" on veterans, especiall~ homeless veterans. Separately ventilated smoking rooms are neither~i practical nor affordable for the Coalition to build. Furthermore,t! homeless veterans very often have a major problem with substance~i abuse. A first step in relieving homelessness is to deal with substance abuse problem. It is "to0 much" to try to deal at same time with other behaviors such as smoking, coffee drinklng.~ and sugar intake. He testified that you cannot put a recoveringi:~i homeless veteran in a restrictive nonsmoking environment and!~!. expect him to succeed. Thus, a smoking ban would influence well a homeless veteran does if he is placed in new employment. Donna Thompson owns a home-operated business, Employment.:~i Research Services (ERS) . ERS provides background research~{ services for employment candidates for company clients. As a result of the OSHA rule, she would not be able to smoke in her own~!~ home, nor in her car while traveling on business trips. She~ refuses to leave her own home to take a smoke break. If she were.~ required to build a separate smoking room in her house, she "would~ be put out of business." She argued that the issue of tobacco~ smoking is "something we could work out" on "our own." Mel Parsell testified as the owner of a small business~ that sells crime prevention products to distributors. His firm,~ National Tech Systems, markets a key chain and pocket pen which~ will spray a pepper gas/tear gas combination to be used for~ personal protection. He also markets personal and home alarms~ which emit shrill attention-getting sounds. He employs about.~ sixteen people and has "had no problems whatsoever" with smoking.~ In fact, he once polled his employees about his firm's smoking~ policy and found that they were "happy" with the current smoking~ and nonsmoking arrangements and that they "don't need any new~ regulations." In his current facility, there are two coffee break rooms, one where smoking is allowed and one where it is not. He~ testified that his employees often work and talk about business in~ the smoking room. During questioning, John Rupp addressed the issue of rooms in which smoking is allowed being used for work-~ related purposes, and in this context, Mr. Parsell testified that~ "not working in a smoking room" is the "most ridiculous thing I've~ ever heard." Rita Underwood is a cosmetologist and co-owner of a hair<~ salon called Hair Now. She allows smoking in her establishment.~ and has found that smokers are "for the most part, concerned and~ courteous towards nonsmokers." She testified that her hair salon~ was too small to build a smoking only room and this would be cost~5 prohibitive as well. William McCarty is president of McCarty-Hull, which is distributor of wholesale goods, including food, groceries,:~-~ tobacco, candy, health and beauty aids and other products testified that he and his company had already developed a smoking$$~
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policy that the company was happy with and that regulation was~i therefore not necessary. In his company, there are separate~i smoking and nonsmoking areas, and for private working areas,~.~ smokers are allowed to smoke. Based on a questionnaire survey his employees, his smoking policy was "right on target." Mr.~: McCarty also testified that "we couldn't afford" to build prlvate smoking rooms. He further argued that the smoking issue was both.~ a "personal freedom" and "productivity" issue, because some of his~i most productive people are smokers. He testified that a smoking~i ban would have a "very negative impact on productivity." Although not scheduled to testify, an individual in the<~i audience approached the OSHA panel and the Judge during a short~: break after the last scheduled witness, with a request to present~i testimony. He was allowed to do so. The witness, Frank Barnes,~<~! is from Palm Beach, Florida, but has no corporate affiliation. He.~ is involved in the development and marketing of an air cleaning device to address ETS in the workplace. He provided copies of-~ photographs of this product to both the OSHA panel and to the~ Judge. Apparently, this is a booth of some sort, perhaps around~ the size of a telephone booth, which has a fan above it, which is connected to a filtration system He claims that essentially i00%~ of the smoke is captured by this device, which is then filtered~ and recirculated. This device could be exhausted to the outside,-~ but is not specifically designed to do so, because that would limit its usefulness only to those businesses which would easily allow such construction. Mr. Barnes hoped to get feedback from.~ OSHA concerning product modifications that might make his air~ cleaning system better meet OSHA standards. Today's testimony continues to build a record of opposition to OSHA's smoking rule by private citizens and~ organizations, particularly small businesses, on the grounds that what OSHA is proposing is not feasible, is cost prohibitive, is unnecessary because of voluntary efforts to accommodate smokers~ and nonsmokers and is excessive governmental intrusion into individual rights. This is effective testimony. One way in which~ OSHA, primarily through questioning by Ms. Sherman, has been attempting to weaken this testimony has been to attempt to show a~ connection of several of the witnesses with Philip Morris. Thus,-~ Ms. Sherman asked the majority of today's witnesses who invited them to testify, or where they had heard about OSHA's proposed rule or whether they had read it. The last three scheduled.S2 witnesses (Parsell, Underwood and McCarty) each acknowledged they had been contacted by Philip Morris. This did not detectably~ weaken their testimony, because it was clear that each witness had~ a story that they wanted to tell at the hearings and testifying about how OSHA's rule would affect their specific..~ business and personal situations. 4
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The hearings were adjourned at approximately 3:30 p.m.~,.:i and will reconvene at 9:30 on Wednesday. The scheduled w±tnesseg,,~i are Dr. Michael Hodgson, who testified on October 25 for OSHA whose appearance tomorrow is on behalf of ASHRAE, the National~-~.oi Federation of Federal Employees, the American Association Occupational Health Nurses and the engineering firm of Ergotec,-.-,.-~i which will testify about electromagnetic radiation as a factor IAQ. Ms. Sherman said that the National Vietnam Veterans?..',,.';i Coalition, which was scheduled to appear today, but failed to so, may testify tomorrow.
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DATE: OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE November ~, 1994 "2.2"." ..-~.~ REPORTEg : WENDELL L STONN}~I SHooK, The main testimony today was given by Michael Hodgson M.D., on behalf of ASHRAE, although four other witnesses als~i testified, representing: a veterans group in opposition to OSHA'S~ ETS rule; an association of occupational nurses in support of OSHA's ETS rule; a union of EPA employees that focused on issues other than ETS, and; an engineering firm, on the fringe o~.~.'~ scientific thought, which attributed workplace health complaint~"~ mainly to radiation from electronic devices. Richard Daynard (a~ law professor at Northeastern University, who is active in smoking~ and health litigation) was present in the morning session. H~.~ intended to question Dr. Hodgson, but was unable to do so becaus~i~ of Dr. Hodgson's travel schedule. Shortly before the proceedings~$~ were opened, Daynard was seen in an auditorium aisle conversation with Dr. Hodgson. Mr. Daynard did not question any~[~ of the other witnesses. The hearings opened with the shortest and most effective~ testimony given today. This was a statement by J. Thomas urch,~.~ S Jr. who is Chairman of the National Vietnam Veterans Coalition~ (NVVC) Judge Vittone commented publicly that he recognized Mr.. Burch as his former ROTC commander. The NVVC represents 78~.~. individual Vietnam veterans organizations, with a total of about~{ 350,000 members. Mr. Burch testified that post-traumatic stres~-~ disorder is a major problem among Vietnam veterans. In efforts reach out to these veterans and get them into treatment, the~ veterans are encouraged to relax. If they were not allowed the~ relaxation from smoking, it would make it more difficult to ge~.i~ these people into treatment. Beyond the PTSD issue, veteran~ generally like to smoke and not allowing them to do so wouldi~ affect camaraderie. Veterans are probably stronger in their~ attitudes about smoking than the general population. For example,:i..~ in the context of questioning by Ms. Kaplan from OSHA, hei~ described the Vietnam veteran's attitude as being one of wantlnq~.. "to be left alone." They "resent it very deeply" being told they.~ can't do something like smoking. "The ones who want to smoke, they want to smoke, and if they can't smoke, they'll get up an~! walk out." A ban on smoking would decrease the ability of the~ veterans associations to draw people to their functions and t~i provide a supportive social atmosphere in those functions.
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-, f Michael Hodgson, M.D an occupational physician rom~ the University of Connecticut, was the next witness to testify.~i Dr. Hodgson had appeared previously at these hearings as an OSHA~i witness. His appearance today was on behalf of the American~! Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc. (ASHRAE) ASHRAE is a technical society of approximately.~ 50,000 members, composed of engineers, contractors, design~j professionals, and other representatives from academic and~! research institutions, manufacturers and government. Among~i ASHRAE's most important functions is the development of standards and guidelines for designing, operating and other aspects of~i building systems, an important component of which is ventilation.<~.ii Although ASHRAE has no authority to promulgate binding standards,.~i ASHRAE's standards are often incorporated into state and local~i building codes and are therefore extremely influential. In the context of OSHA's rule, the most pertinent~ standard is Standard 62-1989, which specifies "minimum ventilation~ rates which provide acceptable air to human occupants of indoor~ spaces and which are intended to minimize the potential for~ adverse health effects." ASHRAE's overall position is that~ "Standard 62-1989 should be widely disseminated and referenced by<~ state and local building codes." ASHRAE recommends modification of OSHA's proposed rule to the extent that OSHA's rule departs~ from specific actions covered in ASHRAE's Standard 62-1989. In~ his oral comments, Dr. Hodgson focused on the issues of who would be responsible in monitoring IAQ, recommended levels of relative~ humidity, carbon dioxide limits, implementation and enforcement~ and the use of private sector standards (such as ASHRAE's) for'~ governmental purposes. He did not discuss ETS in his prepared~ comments Although Dr. Hodgson provided only a five minute~% statement, he was questioned for approximately an hour by the OSHA~ panel. Despite repeated attempts to solicit additional details of~ ASHRAE's views on IAQ issues, Dr. Hodgson avoided almost all of~ the questions on the grounds that he was speaking on behalf of~z ASHRAE and would not comment unless there was a "consensus " vlew already established by ASHRAE. Essentially this was a sltuation%5 in which if ASHRAE had not already expressed its "consensus view" in the form of an approved standard, then Hodgson was not going to~ elaborate further. Nevertheless, Dr. Hodgson acknowledged controversies on~ certain definitional issues. For example, Ms. Kaplan from OSHA~ observed that the written submission had noted that "health" and~.~ "comfort" are frequent topics of discussion within ASHRAE. In-~.~ commenting on this, Dr. Hodgson stated that "the very definition~ of health is quite controversial in the modern world."~ Furthermore, "comfort is equally difficult to define." W~th~n~ 2
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ASHRAE committees, there is "vehement" discussion of what these.~ words mean and what their purpose is. Standard 62-1989 is under revision by ASHRAE. During~i OSHA's questioning, Dr. Hodgson commented that the government's~ position that ETS is a carcinogen will probably effect the revised.~i standard, but no one really knows what that effect will be. He.~i testified that systems could be designed to eliminate ETS from the~i environment. He cautioned that ASHRAE is "not a health society," but rather is "an engineering society and takes its guidance from health authorities." If health authorities decide that no level~i of ETS exposure is acceptable, "there are ways of meeting that~i requirement." Dr. Hodgson was questioned for short periods by Richard<~i Gross (National Energy Management Institute), Mike Lowe (WashTech) and Jim Dinegar (BOMA) . Mr. Dinegar raised a question about the absence of representatives from the building industry on the.~ committee that is revising 62-1989 and then asked how many~ representatives of the tobacco industry are on that committee. Dr. Hodgson said he didn't know. Dinegar specifically asked whether Elia Sterling was a member of that committee Dr. Hodgson said that Sterling was not a current member, but was a member of the committee that developed 62-1989 ..... Richard Daynard then approached the podium and stated that he was representing the American Medical Association and several others. He further identified himself as involved in the Castano class action litigation against the tobacco companies and said he was at the hearings pro bono. He said that he was~ "loosely affiliated" with Mr. Motley and Mr. Myers, who had been at the hearings last Friday for cross-examination of a number of witnesses opposing OSHA's smoking ban. Before Mr. Daynard was allowed to begin questioning, a discussion developed involving Dr. Hodgson, the Judge, Daynard and other potential questioners, ~ stemming from Hodgson's stated necessity of leaving to catch a plane. The situation was resolved by the Judge obtaining.~ agreements that all of the questioners, reluctantly including Daynard, submit their questions in writing to the ASHRAE offices, which would then forward them to Hodgson. Once this agreement was-,--~ obtained, Dr. Hodgson rushed out of the auditorium. J William Hirzy, Ph D testified on behalf of Environmental Employees Collectively Organized, which is the successor to the National Federation of Federal Employees. This union represents about 1,500 EPA employees. Dr. Hirzy has Ph.D. in chemistry, is a senior scientist in risk analysis at the EPA, as well as a union officer. He was with the Monsanto company for nineteen years. Dr. Hirzy's testimony focused on the experience
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of federal employees at the EPA headquarters in Washington, D.C.~ Soon after installation of new carpeting, a number of employee~!~i complained of eye and respiratory irritation, nausea, ski~ problems, headaches, memory loss and confusion and others reported~'~i more serious problems, particularly multiple chemical sensitivity. These problems were eventually attributed to chemical emlsslon~i from the carpet. The cost for studying, retrofitting and~ otherwise attempting to resolve this problem with the air quality~ in the EPA headquarters was approximately $8 million. The union's~i recommendations to OSHA focused on lessons learned from thi~. experience, including the need to monitor airborne substances i~l~i addition to carbon dioxide in buildings in which complaints have~i surfaced, the need to "air out~' carpet, furnishings and other~i materials involved in renovation and the need for more specific~i rules about minimum fresh air requirements. The next testimony was provided by Ms. Bert Dump~,~q representing Ergotec Association, Inc., an engineering firm Arlington, Virginia. Ms. Dump~ provided the most entertainin~ testimony of the day, which she animated by setting up on th~ witness table three skeletal dolls as props representing a~ construction worker, an office worker and a grocery store clerk a~,,~ a check out counter, each of which experienced work-related healt~ problems from radiation exposure to various parts of thei~ anatomy, which could be appropriately illuminated with little red~ lights attached to the skeletons. Ms. Dump~ testified that OSHA doesn't recognize that th~ workforce is different from what it was a hundred years ago Before the development of high tech workplaces, with theiri~ computers, faxes and other electronic equipment, people did not~ have the sort of health problems that they have now, even thoug~-~ they smoked. Thus, the problems in workplaces today cannot be~ attributed to smoking or ETS exposure. Ms• Dump~ specifically~<~ focused on cathode ray tubes, which are a continuous source o~ radiation exposure to workers at video display terminals. She~ testified that sitting in front of a cathode ray tube cause~ reversal of the electrical polarity of the body and this creates~ "tense nerves" and a variety of other problems. Ms. Dump~[~ testified that a worker in front of a computer is a conduit fom~! transmitting the "energy" of the monitor to the ground and "no one~ is going to survive this" over time. Breast cancer is also~. related to exposure to electronic equipment ~in the workplace. Sh~i,~~ argued that the tip of a woman's breast is normally cooler thah~ the rest of her body. A woman sitting in front of a v~deo~ terminal all day absorbs radiation from that terminal, resulting~ in a warming effect on that part of the anatomy, which, in turn,.< leads to the development of breast cancer. The only questioning directed to Ms. Dump~ was by Ms.¢ Kaplan from the OSHA panel. This provided an opportunity for Ms.~ .... " ~59 4
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Dump~ to repeat her dire warnings that "you can't put electronic ,~i products in front of people and expect them to survive." We also learned that if you are "sensitive, as she is, "you can feel" the .... presence of electronic equipment in a building. She stated: "I can walk into a building and sense an electronic product" even if she cannot see it ...... The last witness was Geraldine Williamson, an~Si occupational nurse, representing the American Association of Occupational Health Nurses (/~OHN). The I~OHN is the professional organization of over 12,500 registered nurses who provide health ~i care services at the worksite. ~OHN believes that "all workers;~i should be provided a smoke-free work environment." Tracking OSHA's views, the AAOHN specifically recommended the requirement of a designated smoking area ventilated to the outside with~,<~i negative pressure. The basis for the association's.~ recommendations was stated to be "improved worker health, decreased worker absence, decreased use of health benefits, .~ improved work environments for employees and clients, and& additional cost savings through decreased deterioration of ~.~ furnishings and equipment " • The association's claim of health, absenteeism and cost benefits related to eliminating ETS from the workplace was the primary focus of the questioning of Ms. Williamson. It was solidly established, primarily during cross-examination by Mr. Furr and Mr. Rupp, that the AAOHN's position regarding ETS was developed without a specific review of the ETS literature, much''~ less any research, since this organization does "not do research of any type." The AAOHN did not perform a systematic review of the data relating to ETS exposure and worker health. Ms. "~ Williamson is "'not an expert" in the ETS area and was not able to cite data relating to decreases in absenteeism, use of health,, benefits, or other claimed positive effects of a smoking ban. The hearings adjourned slightly before 4:30, to reconvene at 9~30 on ~hursday. ~he schedule for tomorro~ includes.~ testimony from a variety of witnesses, ±ncluding scientists, small~)~i businesses and associations. ~.D. Lee will also appear, and the Judge specifically stated that he would testigy last.
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OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE DATE: November 3, 1994 REPORTER: ALLEN R. PURVIS~.~i SHOOK, HARDY & BACON ................... Those regularly attending the OSHA hearings arrived this~21i morning expecting a calm day of testimony featuring two of industry's witnesses. The expectation of calm was shattered when~,~i Ron Motley and his entourage of strange of bedfellows arrived with~'~i a flourish at 9:30 a.m. Motley was again accompanied by Professor Richard Daynard of the Tobacco Products Liability Project ofo?~ Northeastern University, Matt Myers from the Coalition on Smoking~ or Health and J.D. Lee, a plaintiff's attorney in tobacco cases~.-~ from Tennessee The remaining dozen members of "Morley's crew, eight of whom are young women, appeared to be lawyers, paralegals~ and six young women who appeared to do no work at all other than serving as a ready-made audience for Morley's antics. These can<~ probably only be classified as "Morley's Groupies." Despite all~.,~ the commotion, the substance of the group's participation ~n' today's hearing was rambling and had virtually nothing to do withi~ ETS and everything to do with Motley's lawsuits against the tobacco industry. In a highly unusual move, the normally mild-mannered~.~ Judge Vittone called Motley to the podium before the hearing.~ began. He asked Motley if after appearing last Friday he had glve an interview to the York Pennsylvania Daily Record no~ing that his comments gave Judge Vittone some concern. The article apparently[..~ reported something to the effect that for the last two months well~ meaning opponents of cigarettes have been beaten up by slick,.~:.i tobacco lawyers. After Motley confirmed that he had made such a~ statement, Judge Vittone indicated that he had a problem with thati'.,~ because he had a completely different view of what had been<~ happening and he resented the suggestion that people had been~ allowed to get that out of hand. Motley refused to take his%~ tongue lashing quietly and argued that the tobacco lawyers have a~ history of being well-financed and well-prepared to point deficiencies in people's testimony. "People have asked me to come.~ here because they are not as well prepared or as well financed."'~<-~ Motley acknowledged that his statement was solely based on people had told him and the Judge indicated that his personal<~ perception was based on being at the hearings every day. 10964658
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10964658 The Judge also questioned whether Motley hired detective to dig up dirt on the head of the smokers' alliance and~ Motley denied this, claiming the individual had only been hired to get a photo of the city hall where the testifying mayor worked. The Judge ended the session by indicating that he had'~4i simply wanted to put his side of the issue on the record and to this Motley answered in a smart-alec tone "I'm sorry, I didn't realize judges in these matters took sides." Motley then returned triumphant to his audience smiling and joking about what had just.~i taken place Noting that it was going to be a long day, the Judge.~! began by calling Ms. Susan Addis of the Association of State &~i Territorial Health Officials (ASTHO). In a brief prepared'~I statement, Addis strongly endorsed the concept of clean indoor air.~ and urged that the ETS portions of the proposed regulation be separated from the IAQ provisions so the ETS portion could be~ expedited through the rulemaking process. Noting that there was~ no known safe level of ETS exposure, she recommended a zero tolerance policy and even urged that smoking outside buildings, where it could drift back into the building through windows doors, be prohibited. She also advocated a provision that would~q prevent OSHA's regulation from preempting stronger state~ regulations and characterized OSHA as establishing a minimum standard. She concluded by recommending that first-time~ violations be treated as an opportunity to increase employer and~ employee education about the hazards of ETS rather than as an~ opportunity for a monetary fine. Rupp's examination brought out that Addis has a masters in public health from Yale but she repeatedly refused to offer opinions or interpretations on scientific issues, claiming that~ she was not a scientist. The group's support of the OSHA~ regulation was based on acceptance of the EPA report, which Addis~ admitted she had not read. Addis insisted that if workplace smoking was banned,~ workers would not be exposed to any of the chemicals in ETS even<.~ though she did not know that many of those same chemicals were in~ the workplace from other sources. Even after Rupp suggested that~ there were other more dominant sources of chemicals in the~ workplace than ETS, Addis insisted that ETS be banned because she~ was convinced this would result in a measurable reduction i~ • exposures to carcinogens in the workplace. It was clear at th~s~ point that Addis' opinion in the group's position was based on a.~ presumption that ETS is an equivalent to poison gas and a whiff of~ even a molecule or two could prove deadly.
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During his brief examination, Weinberg of Wash Tech~ brought out that the EPA had enacted asbestos removal standard~i~i years ago based on faulty information and many now admitthat their regulations were a costly error that did not result in protection for the public. Again claiming ignorance of scientifici! issues, Addis nevertheless proceeded to suggest that it was~i permissible in the area of public health for an agency to create a~ regulation without adequate scientific information. "We have to wait until the bodies pile up.~ Motley conducted a friendly examination of Addis that~i was really more of a show for his audience than anything else Mocking earlier testimony that tomatoes and raw eggplant possibly.~I could create significant levels of cotinine in the human body,~i Motley asked Addis, "Have you ever seen anyone addicted to tomatoes or raw eggplant?". Daynard tried to formulate a series of questions wh~cb~ were basically unintelligible but fortunately brief. The only<~ point he made was the fact that Addis' Connecticut state health~ office building where she worked did not set aside a place for t e~ consumption of alcoholic beverages, apparently suggesting that it%~ shouldn't set aside a smoking lounge as proposed by OSHA. At Ii:00 a.m., the first industry witness, Dr. Jeffrey~ Idle of the University of New Castle (United Kingdom), began his~ testimony. After acknowledging that he had been asked to testify~ by Philip Morris, Idle indicated that he was a professor of~ pharmacogenetics at New Castle University and also served as the~ Head, School of Clinical Medical Sciences. A trained chemist,~ Idle indicated that he had recently received certification as a~ fellow in the Royal Society of Chemistry. He is the author of 280~ scientific articles and is the founding editor and editor-in-chief~ of the journal entitled "Pharmacogenetics.~ He has worked with~ the National Cancer Institute, USC Public Health Department, Th~ American Health Foundation and the Parkinson's Institute Idle indicated that Philip Morris asked him to review~ the proposed OSHA regulation and he found many problems with it.<~ He noted there was a lack of proper quantitative evaluation in the~ proposal and questioned the applicability of animal studies humans in light of animals' different metabolic rates. He also~ objected to the proposal's use of nicotine as a surrogate for~.~ other ETS components because nicotine behaves quite differently Idle indicated that his major concern was the lack of a~ dosimetric analysis for exposure to ETS. He then proceeded to~ walk the audience through his calculation of ETS exposure using dosimetric model. His worst case scenario envisioned a 7' x 7'~
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office where one worker smoked 20 cigarettes a day over an eight~ hour work period while the nonsmoker, obviously, smoked none. He then explained that the following modifying factors have to be accounted for in order to create the dosimetric model: occupancy~i density, air exchange, use of filtered versus unfiltered~'ii cigarettes, sidestream to mainstream smoke ratio, pulmonary%i retention, relative proportion of sidestream/exhaled mainstream smoke and exposure time. In every instance, Idle's model was a worst case scenario when compared to published and accepted data. For example, his model only assumed one air exchange during eight hour period when the accepted standard is I0 such exchanges during a period of time. Each of these modifying factors resulted~,~i in a mathematical amount which Idle used to calculate his time- weighted values Idle then displayed a series of charts which compared the estimated worst case exposure to various smoke chemical constituents from ETS to approved OSHA occupational exposures and.~ in every instance they were well below what OSHA would permit a worker to be exposed to in the workplace. In some cases, such as with the chemical hydrazine, the exposures were minuscule -- 1,300,000 times lower than the amount permitted by OSHA. For even some of the more condemned constituents such as benzo[a]pyrene, the amount of exposure predicted in ETS by the model was 200,000 times less than permitted by OSHA. With specific reference to benzene, Idle pointed out that the level in ETS was far lower than the amount normally encountered in urban areas and even some rural areas. His bottom line conclusion was that ETS could only add an,~ infinitesimally small incremental amount of benzene to outdoor air. His final conclusion is that his valid model demonstrates that ETS does not reach a level of concern in the workplace. Sherman began her examination for OSHA at 11:45 with the obvious questions about primary causation. Idle responded that in his opinion cigarette smoking was a risk factor for lung cancer,~ but he avoided any statement as to causality Idle condemned OSHA's reliance on a single smoke constituent in concluding that it was a surrogate for other constituents and recommended a much broader approach. Sherman pressed Idle for specific recommendations for other biomarkers that he would approve of and Idle provided a few suggestions. Idle also brought up that he and his colleagues have performed a test to prove the unreliability of cotinine as a ~ marker of other smoke constituents With 120 volunteering nonsmokers in England, each was given a 2 milligram capsule of nicotine and then various bodily measurements, including body fluids were taken and measured. Idle stated there was a ,
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tremendous variability in the sample's reaction with some peopl~ producing a lot of cotinine and others producing none. H~i concluded that this intersubject variability prohibits reliance on~! cotinine as a surrogate for all ETS smoke constituents. After a slightly longer-than-usual lunch .break to enabl~ Idle to review the proposal in order to respond to some of~ Sherman's questions, testimony resumed again at 1:45 this~i afternoon. Sherman began by expressing surprise that Idle'~i presentation of a dosimetry model was not included in his writte~ submission and therefore should not have been permitted. After debate among the lawyers, it was suggested that Idle may have t~i return on the Monday following the Thanksgiving recess to answe~i questions about his model, although Andrade of Philip Morri~i offered to have Idle answer any such questions in writing -- offer which Sherman rejected. While this discussion was takin~ place, Motley was laughing and joking with Janes and Repace o~$~ OSHA. It appears Motley is perceived as the white knight ridin~ to the rescue of the beleaguered OSHA regulation, although hi~ performance has yet to justify any such characterization. Sherman used the rest of her examination to go overn picks in Idle's written statement. Questioning why he objected t~ regulation of CO2 levels caused by ETS, Idle replied that he wa~ not impressed with epidemiologic studies that came up with minof~ relative risk ratios when he has done the calculations and know~ how trivial ETS is as a contributor of CO2. "Why regulate minor sources and not the major sources?" Sherman seemed especially proud of her criticism o~ Idle's criticism of OSHA for relying on a Chinese study. "Do yo~ believe all four language papers should be ignored?" Idl~ replied, "No, but the leading scientific journals are al~. published in English." Daynard took another crack at trying to formulate comprehensible question but the only one reasonably understandabl~ was a question as to whether Idle believed nicotine was addictive drug. Idle replied, "I have very great doubts abou~ that -- it does not really fit into the classical definition addiction that we find in the textbooks and nicotine is not on th~ list of addictive drugs we teach to our medical students Daynard apparently thought he was going to catch Idle in scientific violation when he questioned whether the nicotine stud~.~'-~ • Idle conducted had been approved by Britain s equivalent to t Institutional Review Board, to which Idle replied, "Of course the~ approved it." Daynard sat down.
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~otley then rose to begin his 30 minutes of examination. Dducing himself to Idle, he advised the doctor that he a number of entities, including a number of "victims." ng Idle state that he doubted ETS causes any human ~otley brought out that Idle's university has a no >licy, which Idle readily acknowledged. With great Motley confronted Idle with a university brochure, hot off the fax lines, stating the university's no .licy. Idle explained that he had resigned from the ~hat established the policy because they simply based it ~ived right to breathe smoke-free air rather than on he believes such decisions should be based on. ~otley then attacked Idle for his service as a member of ientific Advisory Board between 1986 and 1991. Trying that Idle had an intensive involvement in smoking ~he witness effectively downplayed his involvement and it simply meant that twice a year he went to New York .e of days of meetings to review grant applications -- ich did not even deal with tobacco. [otley then tried to make a big deal out of th~ fact ity of New Castle's offices are nonsmoking, to which :d that he was surprised because he thought the people : smoked more than any other city in the United h the possible exception of places in Scotland. ext Motley tried to bring out that even though Idle had OSHA's initial draft for failing to provide references ~ his statements, he was associated with CTR and the ustry, which didn't share all of its information with and the public. Motley then confronted Idle with the ndustry documents that have been seen in prior to the effect that CTR is "the best insurance" and ~hat CTR's work was selected for public relations and 91ations objectives rather than scientific ones. Idle ied that he had never seen any of the documents and : of the documents were used, Andrade objected that s had nothing to do with ETS and objected to Motley proceeding to further his other interests. When Rupp n in the objection, Idle asked the Judge if he could ~s "to empty my bladder and maybe you all can continue ~tley then continued down his checklist of items that to him by three of his assistants from the front row .o time. Idle denied knowing a Dr. Green, a former BAT, and claimed he had never heard of DeNoble of is. When Idle inquired as to whether DeNoble was a Lte of ~_ with, ~s tota i iy~i ~t he had?~ ~ said, "I that I presented~ , tried ~ into ge final ly~ o~ent but pr imar i ly~ ~ Benowit ~.) totinine is~ -e~<~ ~d by a ~ues shouldl f Stan ford"~ r t es t imony)~} :15, Rober t,~ Virginia.~ yees makes reties and ~ sugges~ t o.~ ~d it would~ ~late. He~; ~rato~ and :~ He also }f ~iimat e f o ~ he propo sed~.~; ~he loss of~
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Motley s examination began by confronting Williams w~th~ a chart of products manufactured by World Candies, Inc. Motley~ wanted to know whether this company was one of G.D.'s customers. Although it could not be seen by the court or the observers, was obvious that the chart was a picture of candy cigarette~il packages. Williams looked confused and said, "I'm here about.~i indoor air quality -- what relevance does this have to that?'~fi Motley snapped, "Are you a judge?" When the Judge intervened,~f~i Motley brought out the fact that GoD. was a member of the National~S~i Smoker's Alliance, but Williams denied being a major participant.~i When asked if he had met with any lawyers from the tobacco~i industry, Williams indicated that he had discussed what he going to say with a lawyer for the industry "just like I would~:~i tell Hershey chocolate, also one of our clients, what I was going~i to say if they were proposing to ban chocolates from the workplace " • In response to brief questioning by David Smith of~ Consteangy Brooks & Smith (Philip Morris OSHA counsel), Williams~ recounted how a nonsmoking and smoking worker at their plant had~ indicated that the proposed reg would interfere with their~ socialization during breaks and urged the company to oppose it. At 5:05, J.D. Lee began his 20-minute rambling statement~ endorsing the ban on smoking in the workplace. Interestingly, Lee!~ saw the proposed regulation as a complete ban rather than OSHA's~ argument to the contrary. Lee indicated that he owns a no smoking~ building in Knoxville and then he proceeded to quote from various~ Surgeon Generals Reports and other government scientific reports~ in support of his attack on primary smoking. Just as it appeared$~ the Judge was going to halt his testimony because of this, Lee~ would return briefly to the subject of ETS only to then again launch into an attack on primary smoking. Lee cited the panel to the Tennessee Supreme Court~ opinion of 1896 in the case of Austin v. Tennessee, where that~ court describes cigarettes as "wholly noxious and deleterious, "their use is always harmful," "they possess no virtue," and "they~ are inherently bad and bad only." He ended with an attack on thei,~ industry°s $5.2 billion advertising expenditures which he~ calculated to be $14,300,000 each day "to replace dying smokers." Ward of RJR began her examination of Lee by eliciting~ his admission that he had brought a number of unsuccessfulo~ lawsuits against tobacco companies since 1983. He reluctantly~.~ acknowledged that if the 0SHA regulation goes into effect he could~ use this to his monetary advantage in lawsuits against cigarette~< companies just as he has tried to use Surgeon Generals Reports as.-~ evidence against the companies. 10964658
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During his brief examination, Weinberg pointed out tha~i Lee's written statement had referred to a 1974 OSHA standard od~i exposure to vinyl chloride and had claimed that this carcinogen"! was found in ETS. Weinberg demanded to know on what Lee base~i such an opinion because vinyl chloride breaks down when it come~i in contact with air. Realizing he had been caught, Lee insisted~ that it was his impression from reading the Surgeon General~i Report that vinyl chloride was contained in ETS. Weinber~!i demanded that Lee point out where in the Surgeon Generals Report!I this was stated in a post hearing comment. ~i Like a tag team wrestling match, Weinberg turned th~i vinyl chloride issue over to Andrade, who asked if Lee was awar~i that vinyl chloride was not a lung carcinogen. Visibly getting!!i weaker in his statements, Lee claimed that he was only "echoin~ authoritative sources." Andrade advised Lee that vinyl chloride~ had never been measured in any of the ETS studies and stated, "Yo~ don't even know if vinyl chloride is present in ETS and yet yo~ choose it as your example." Andrade ended his examination b~ wondering whether Lee had used the same care and skill i~ preparing his entire report as he did in relying on the viny~i~ chloride example to which Lee did not reply, i~ Daynard's brief series of questions simply provided Le~ a further forum to embarrass himself. Lee acknowledged that h~ had made absolutely "zero" on his tobacco cases and in fact had ~ huge deficit from them. Daynard wondered why Lee had undertake~~, this work even though fellow lawyers told him that it was no~!~ financially feasible to pursue such cases. Lee then wrappe~ himself in the cloak of charity and then claimed that he wa~ taking these cases as part of his pro bono effort -- not realizing, that he had already implicitly suggested that he was in thos~. cases for money. In other words, if he won he would take th~ money and claim himself a great slayer of the tobacco dragon bu~ if he lost he simply classified that as working for poor people ~ Judge Vittone announced that he will be replace~ tomorrow by Judge Will to which Ward quipped, "By the end of th~ day he will be Judge Won't." -~ Six witnesses, including Dr. Hubert, are scheduled tq~ testify tomorrow. .~<~ ~.0964£S~
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DATE: OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE November 4, 1994 REPORTER ~ /~LLEN R. SHOOK, When substitute Judge Will convened today's hearing 9:30, industry representatives breathed a sigh of relief as Motley<%~i and his group were nowhere to be found when industry expert,~.~i Dr. Helen Hubert, began her testimony. The sigh was premature, Motley and most of his entourage trickled into the auditorium one by one and without fanfare. As happened yesterday, fear o~-"~ Morley's cross-examination greatly exceeded the examinatio~[~ itself, which today was much shorter and less dramatic. Thre~ other witnesses filled the remainder of the day, with the fina~ witness being a strange woman claiming to be suffering fro~ multiple chemical sensitivity caused by ETS. She spoke with he~ ever-present gas mask on the table within arm's reach to protecd~.} against emergency ETS exposure. Hubert is a Ph.D. epidemiologist and is currently Senior,S. Research Scientist at the Stanford Medical School. Sh~ specialized her study in chronic disease epidemiology and receive~-~ her degree from Yale. She worked at the National Institute o~ Health for six years and studied the Framingham epidemiological~i project intensively. She described this as the best-designe~ cardiovascular disease epidemiological study yet devised. Hubert testified that she was contacted last May b~> Washington Technological Group to conduct an independent review o~[~ the propriety of OSHA's rulemaking. Despite her affiliation wit~ Wash Tech, she stated that her comments today represented her own~ views Hubert testified that, in her opinion, it wa ~..> inappropriate at this time for OSHA to conclude that there was true association between ETS and cardiovascular disease. She then-'.-~ proceeded to discuss the underlying epidemiological studies in th~!~ area of ETS and CVD. She noted that 15 scientific publication~.~! had resulted from the 13 CVD studies and, of these, only fiv~ showed a statistically elevated risk for CVD from ETS. She note~ that three of the five had very weak associations After reviewing the numerous risk factors for CVD tha~![~ had been identified in the Framingham study, including age,q.~"~ 10965275
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obesity, sedentary lifestyle and cigarette smoking, she proceeded~ to note that none of the five studies properly controlled for more than one or two of these factors and, therefore, the result had to be suspect. In addition to the failure to control for confounding~i factors, she criticized other methodological features of each the five studies which, in her opinion, seriously jeopardized validity of their findings. For example, in the Hole study, the researcher defined a person as being ETS exposed if they were'~ii living with a smoker or an ex-smoker even though the ex-smoker mayij~!i have quit smoking before they got married. In summary, Hubert felt that there was very little<<--,i adequate data in the scientific literature and no U.S. data to~ support a true association between CVD and ETS exposure. She urged OSHA to develop more relevant and convincing evidence before~~<~ even considering if removing ETS from the workplace would reduce~ deaths due to heart disease. Sherman began her examination at 10:00 a.m. by~ suggesting that studies with which Hubert had been associated had.~ failed to control for risk factors such as alcohol and caffeine, to which Hubert simply replied, 'Those are not accepted r~sk%~ factors for heart disease." Sherman tried to make a big point on several occasions out of the fact that Hubert had not reviewed the ETS heart disease review articles published by Glantz and others. Hubert repeatedly.~ explained that it was more important to her to focus on the~ underlying articles because authors can view studies in a%~ different light When Sherman suggested that Hubert was saying • that review articles were of no value, Hubert rejected that contention and again repeated her position that the underlying studies were the best evidence to look at. Hubert rejected the idea that a meta analysis could be.~ performed on the existing ETS studies even though she acknowledged that it was an appropriate vehicle in the right~ circumstances • At 10:35, O'Neill representing Philip Morris asked~ Hubert a few clarifying questions. Noting that earlier witnesses had claimed that the Helsing study had accounted for socio- economic status as a confounding factor and this took into account..5~ many of the other confounding factors, O'Neill had Hubert rebuto~ this contention. In response to Sherman's intimation that Hubert~%~ couldn't evaluate ETS epidemiological studies because she had~ never done one, O'Neill had Hubert indicate that her expertisei~ permitted such an evaluation, especially with respect to lifestyle risk factor such as ETS. O'Neill ended his examination~ 10965275
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by having Hubert confirm that spousal ETS exposure cases are~i inappropriate for determining workplace ETS exposure questions "You must do the work in the workplace." After introducing himself and again announcing that was appearing on behalf of several "ETS victims," Motley began his~ examination at 10:45. As he did with Idle yesterday, Motley.~ confronted Hubert with the no-smoking policy of NIH, which was:~! established in 1987 She was able to take the wind out of sails by announcing that the policy took place after she left NIHi~i and later Motley was overheard returning papers to one of female assistants while saying, "These aren't any good -- she~~i wasn't there after '87." Noting that she had been retained by Wash Tech, Motle~ inquired as to whether Hubert had met any tobacco industry lawyers. Hubert calmly confirmed that she had met with a group Philip Morris attorneys and Motley moved on to another subject. In response to Morley's question about direct smoking a cause of heart disease, Hubert replied that she thought it was~ "a significant respecter." When pressed on the subject, HuberS~ admitted that she thought direct smoking caused heart disease "bu~ the mechanics are still hotly debated." When asked the same~ question about lung cancer Hubert indicated that in her opinion, , it had been established that direct cigarette smoking caused lung~ cancer. Motley asked Hubert if the Philip Morris attorneys had~ given her any of the research of Dr. DeNoble and she replied the negative. She also had no knowledge of what Special Four was~ all about and Motley then asked whether Philip Morris attorney# had given her any in-house studies. When Motley tried to question~> r Hubert about DeNoble's appearance before Waxman in July, And ade~ rose from the audience to try to object but was not permitted do so by the judge. Motley then ended his examination and~ Weinberg rose for some clarifying questions. with respect to the Fontham Study, weinberg had Huber~i.~ explain that she had not looked at that study because it had~ absolutely nothing to do with heart disease, so it did not show on her review of the literature. Hubert's testimony ended at 11:15, and at 11:30 Wayne~ Hansen of Mintie Corporation began his testimony. Hansen is mechanical engineer by training and a certified energy manager.%~$ He applauded OSHA's "courageous effort," but pointed out a problems his corporation had with the proposed regulation. These~ suggestions included an improved definition of the "deslgnate~ 10965275
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person," so that more responsibility would be placed on the person~ having control of the building. He also thought that the~i regulation needed to have a bigger focus on environmental mold andq! should include respirable dust• He urged OSHA to consider~i simplifying the record-keeping requirements of the regulation to allow each company a degree of flexibility in designing its own'~i plan. Sherman tried to elicit specific suggestions on how the~i designated person should be trained and certified, noting t at{i this had been a thorny area for OSHA in other areas. Hansen~ testified that in his vast experience the main cause of poor IAQ~i were environmental mold, respirable dust and carbon monoxide. Rupp's brief examination focused on the difficulty of installing new ductwork in an older building and the difficulty in~ maintaining a negative pressure as would be required by OSHA's smoking lounge regulations After the lunch break, A1 Colon, representing ~h~ International Council of Shopping Centers, presented his prepared statement. His group strongly opposes the rule and compared it to~ the ill-designed rule on asbestos removal which he contends was a~ "disaster." He defended each individual shopping center/mall~ owner's right to establish their own smoking policy consistent with local rules and regulations and noted that approximately 30% of his members' malls still permitted smoking. colon's main contribution was a calculation of the cost~ of training the designated employees, building maintenance~ personnel, and property managers, as well as the cost of~ conducting required IAQ surveys. For an eight-story building, he~ estimated the cost to be approximately $45,000 which, when~% multiplied by the 1.5 million buildings covered by the OSHA reg,~ would result in a total cost of $88 billion during the first year.t~ He urged OSHA not to act until it had better science upon which to base such regulations At 2:10, Sherman began what was, for her, an~ antagonistic examination. She finally had Colon admit that in his~ financial calculations he had failed to account for the fact that~ many businesses are already training their employees in conducting IAQ surveys so the real cost was much less. Although he had~ personally not viewed the science underlying the IAQ provisions of~ • the reg, he indicated that the Council's consultant, Healthy~ Buildings International (Gray Robertson), had conducted such a~ review of the science ~0965275
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After Sherman completed her examination, Dr. Judith~i plotkin, the "gas-mask woman," rose to ask a few questions. The~i thrust of her examination of Colon was that 30% of his agency's..~i membership who permitted smoking were not accommodating people~.! like her who were "respirationally challenged." When she concluded, Judge Will invited her to proceed.:~ with her testimony but Plotkin questioned OSHA's staff and said, "Have you solved the chair problem?" Apparently, Plotkin had~i~.~ demanded a special chair to accommodate her disabilities. After short break, she positioned herself at the witness table in her~i special chair. Plotkin is in her mid to late forties and walks with cane, apparently as a result of injuries received in an accident. She carries a small footstool on which to rest her left foot while~ seated. She was dressed in a dowdy, blue suit complete with a ruffly, white blouse. She had a blue beret on her head and a~ braid down her back which reached her waist. For the next hour, she obviously relished the opportunity to tell her personal~ problem with multiple chemical se~siti~tM. In a somewhat rambling presentation, Plotkin explained that she had a degree in what we later learned to be quantitative genetics. She recounted how she grew up as a child suffering adverse effects from forced exposure to tobacco smoke. She recalled how she had been verbally abused by adults who did not~ want to believe that their ETS was harming her. She urged OSHA~ not to look at the statistical studies which were being attacked, .~ • but rather to focus on individuals such as herself who had obvlous~b disabilities caused by ETS exposure. Throughout her testimony, Plotkin gave several anecdotes which showed her extreme perceived sensitivity to ETS Noting • that on one occasion when there was a fire drill at her office~ building, she returned to the building with a group of employees and failed to notice that someone had inadequately snubbed out a cigarette in the ashtray by the door. She claims one whiff of the smoke doubled her over with an asthma-like attack such that paramedics had to be called to regive her. She also claims have developed the ability to smell minute amounts of tobacco smoke in the air or on a person's body and she characterized this ~ ability with a scientific term of causmia (sp?). She claimed her body developed this ability as a protective measure. Plotkin also discussed the difficulty she has in~ entering a building where smokers are standing by the door, claiming even her gas mask will not completely protect her in such~.~ instances. She also described her difficulties with co-workers and<'5 1.0965275
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in finding a job because of her inability to work next to someone~i who smoked at home before coming to work. In a gentle and subtle examination, Rupp appeared solicit Plotkin's help in trying to advise OSHA on how to proceedS"! in its rulemaking in this and other areas. After establishing rapport with Plotkin, Rupp very subtly suggested that perhaps her~i obsession with tobacco had caused her to focus on it to the.~,~ exclusion of other possible causes of her attacks. Noting that~i the chemical constituents of ETS were also found in the workplace!~i as a result of other contributors, Rupp wondered why Plotkin had~i no reaction to the same chemicals emanating from these othe~i sources. Plotkin tried to contend that there was something uniqu~i~i about the chemicals as they were found in ETS. Next, Rupp marveled at Plotkin's ability to detec~ni someone who had smoked a cigarette outside and then entered the~ room, even at great distances. Plotkin reveled in the attent~o and indicated that she had identified three cigarette smokers the room earlier, but they had all left. Rupp found this amusin~ since of the five people remaining in the audience, three were~ known to be smokers, and plotkin did not notice them. This point~ may be put on the record Monday when Plotkin is not available react either verbally or physically. Rupp worked with Plotkin to suggest to OSHA that perhaps~ one or more entrances to a building should be designated as no-~ smoking entrances to protect people like her. She didn't thin~ Rupp's suggestion that a special provision should be put in OSHA'~[~< rule giving people like her rights not to work next to a smoker, since she thought current accommodation laws could take care this. In conclusion, Rupp confronted Plotkin with a 1994~f> article which suggests that the concep= of multiple chemica%~ sensitivity was very controversial with some scientists thinking~ that no such syndrome existed and it was really a psychological~ problem, plotkin became agitated and said, "Just because someone~ doesn't understand something doesn't mean it doesn't exist." Whed~ Rupp concluded his examination, Plotkin asked for a rebuttal and~ began to react to Rupp's suggestion that this was all in her head,.~ but the judge cut her off saying, "Philosophizing is not~ permitted." No hearings will be held next week, and they will resum~ on Monday, November 14. Two video cameras were in the courtroom today, and was later determined that one was there for the sole purpose 1096527S
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filming Hansen's presentation. Motley's group departed. The other camera left after~..)i The circus atmosphere surrounding Motley yesterday not apparent today. Motley obviously has a rule that no one is sit next to him or bother him before he conducts an examination..~i He sits and listens intently, although he frequently looks around,'.i~ the room while chewing on his fingernails. When he approaches podium, his team of supporters place themselves in the first ro~,,!) behind him, and he turns frequently throughout his examination be handed papers for the next line of questioning. He was polite~i~! to Hubert and the judge and made several attempts at humor durin~..~i his examination. .~,., ~
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OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE DATE: November 14, 1994 REPORTER: ALLEN R. PURVIS SHOOK, HARDY & BACON Having endured antagonistic questioning of industry witnesses by Motley during the last two sessions, industry personnel were nervously scanning the horizon for Motley and company as another industry witness prepared to take the stand. Releasing a collective sigh of relief, observers settled back for.~[~i a shortened day of testimony as only one of four witnesses showed up and Motley did not appear. Rupp began the session by asking the Judge for ~..\ permission to make a brief statement. Reminding the Judge, who was not present for the last session, that Dr. Judith Plotkin had testified about her extreme aversion to ETS, Rupp explained to the Judge how she had testified that she could identify smokers by smell if they were in the same room with her. He explained to the Judge that Plotkin had stated that three smokers had been in the auditorium before she testified but had left thereby implying there were no longer any smokers in the auditorium, at least none that triggered olfactory phenomena. Rupp declared for the record that he and at least one other person who is a known smoker were in close proximity to Plotkin and she did not detect them as such or identify them as smokers. Rupp explained to the Judge that he had refrained from confronting Plotkin with this fact while she was testifying in order to spare her embarrassment. As a practical matter, Rupp did not confront Plotkin in order to avoid a fabricated "attack .... The Judge indicated that he was unaware of the nature of ~[~ Rupp's statement and seemed concerned that Rupp was, in effect, testifying. He invited Sherman of OSHA to protest and she accepted the invitation but without much enthusiasm. Today's witness was J.R. Ashford of Exeter Health Information Services of Exeter, England. Ashford testified that he received a Masters in mathematics from Cambridge University in 1953 and later received a doctorate in statistics from the London School of Economics. Ashford testified with obvious pride that he ~ had studied under the great Dr. R A. Fisher and Dr. Carl Popper. Beginning in 1953, Ashford spent 14 years working with the mining..2 industry in the U.K. to establish clean air standards for coal 51268 24~76 10969361
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mines. He designed and operated what he claims to be the world's .~ largest onsite occupational study to date, which focused on 30,000 ~i coal miners and followed them from between I0 and 15 years. After thanking OSHA for the opportunity to testify, ~'i Ashford indicated that his two main objectives were to draw attention to new data which had come into existence since he submitted his written comments and to emphasize some of the other basic points in his written statement. Ashford's first point was the criticism of OSHA's reliance on uncontrolled studies. He believes these cannot~-$i support the proposed regulation because mere observational data is inherently unreliable. He believes the use of complex mathematical models is faulty when it relies on such observational~~ data and the resulting forecasts are not referable to the real world experience. Returning to his credentials, Ashford noted that he had been a professor of statistics at Exeter University since 1967, although he is now a Professor Emeritus, retired, and runs his own consulting business. He acknowledged some prior tobacco industry~ consultations and indicated that he had been contacted for this project by Philip Morris but he insisted that everything he was saying represented his own personal views. Ashford then attacked the basic sources of information relied upon by OSHA for its proposed rulemaking. He noted that ~ there is no comprehensive or coherent explanation of the underlying mechanism of disease and this, combined with the fact that there is no realistic animal model and the inherent weaknesses of epidemiological studies, should preclude OSHA from concluding that a causal relationship between ETS and human disease has been established. He acknowledged that epidemiological studies are good for identifying hypotheses that ~ should later be tested in the laboratory. Ashford then identified several assumptions OSHA has made which he believes are faulty and which undermine the rulemaking proceedings. In Ashford's opinion, it is wrong for OSHA to assume that persons exposed to ETS are the same as those who are not exposed and that ETS has had an "all or nothing action." He did not believe the studies relied upon by OSHA had sufficiently allowed for confounding factors and he believes that the available literature may be subject to publication bias. ~ According to Ashford, unless these assumptions are validated, the effect of ETS on humans will be exaggerated. 10969361 51268 2~77
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Ashford concluded his presentation by citing the..~ recently published work by Layard and LeVois on exposure to ETS in the workplace and lung cancer. He noted that if two recently published spousal studies (Brownson and Stackwell) had been added to the data relied on by the EPA, there would have been no statistically significant relative risk found. He finished by noting a number of factors (e.g., large variations in the relative risks from study to study), and concluded that any single criticism he was presenting was enough to undermine OSHA's rulemaking and it should cease until adequate data is available. At 10:15, Sherman of OSHA began a wandering examination which Ashford and the observers endured for over two hours. OSHA's scientific staff had prepared a multi-page outline for. Sherman's examination and she was flanked by OSHA scientists who constantly whispered suggested questions, which in many instances ~ were obviously incomprehensible to Sherman as expressed by her facial reactions Although pleasant and polite Sherman's~ examination did little to aid the record or harm the witness Sherman repeatedly tried to narrow Ashford's expertise to that of a mere mathematician and while Ashford refused to extend his expertise in many medical fields, he repeatedly ~stablished ~,.~ himself as a "hands-on" epidemiologist with vast experience in constructing and running epidemiological studies of the highest quality • Ashford readily admitted that he had conducted no ETS studies but when Sherman presumed he had done no smoking studies, ~D Ashford set the record straight by pointing out several of his studies which involved, at least tangentially, the issue of smoking• When asked whether he believes that cigarette smoking causes lung cancer, Ashford indicated that he had seen a lot of data from areas other than the United States and the U.K. that made him question the idea of cigarette smoking as a cause of lung cancer• "I'm not prepared to accept the conventional interpretation there are simply too many anomalies " When asked how he felt about the U.S. Surgeon General's Report on smoking and lung cancer, Ashford replied that he was "agnostic." When she pressed for his views about Doll, the highly respected British epidemiologist, Sherman was surprised when Ashford replied, "Doll is a good friend of mine but his results are seriously distorted by population selection." Similarly, Ashford indicated that he had seen no evidence that cigarette smoking causes heart disease, noting that "the causes of heart disease are~ not well understood in general." Sherman, as she has done with other industry witnesses, tried to pump up the importance of the review articles by Glantz, .~ 51268 247~ ~0969361
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Steenland and Wells, but Ashford replied that he could only ~ remember that Wells' paper, with which he generally disagreed.,~! When Sherman tried to suggest that Ashford had no formal training in epidemiology, he simply smiled, recounted his work ..... with Bradford Hill and R.A. Fisher in the 1950s and 1960s, and said, "I was training with the inventors of epidemiol~gy." Sherman next tried to defend the Fontham study on ETS and lung cancer but Ashford listed his concerns very articulately. Noting that this was the best study available to OStt~ and that Dr. Fontham "did the best she could," Ashford nevertheless criticized the method of selecting case controls which resulted in a control group from a higher socioeconomic strata. He also had problems with Fontham's high proportion of surrogate responses for causes of death and he questioned how Fonthm'n eliminated 96% of ,i..~ the potential cases from her study. Ashford indicated that in his opinion health educators are trying to frighten people with a large number of smoking related deaths that are derived from the CPS I and the CPS II studies. He then referenced research by Sterling which called ~.~ into question the validity of those numbers and suggested that they should be cut in half. Sherman obviously recognized the name .... Sterling and wanted to know why OSttA should rely on his recently ~'~ published work, to which Ashford replied, He looked at a representative sample and he is honest " After the lunch break, Sherman walked Ashford through his criticisms of various animal models working toward the point that in Ashford's mind epidemiological studies were unreliable and animal studies were unreliable, so there was no way to prove causation. Ashford urged OSHA to do its own studies so they would be in control of the various factors._,,,~,~ Sherman ended her examination by wondering how Ashford ~.~ was contacted by Philip Morris, to which he replied that he was simply contacted by a firm of attorneys with a London office and nothing more was said ,.., O'Neill began his series of brief clarifying questions'~ by directing Ashford's attention to the Fontham study. He had Ashford opine that it was not strong enough to support a causal ~...~" relationship between ETS and lung cancer because "an end control";~ study can never prove causation." Next, O'Neill directed Ashford's attention to his slide ° listing various deficiencies in ETS studies relied on by OSHA..~.,~'~ which listed misclassification of smoking status, failure to,~ 5126~ "~479 10969361
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properly account for confounding factors, deficiencies in..~ selection of controls and publication bias. Ashford then applied this listing of deficiencies to the Fontham study and found defects in all categories. With respect to the fact that many of the Fontham relative risks are below 1.5 and all are below 2 Ashford stated that these very low relative risks made him believe.~i that the only reason any discussion or attention was being paid to .~ these results was because the subject matter was ETS. With respect to publication bias, Ashford related a personal experience where he had conducted a well-designed study in Sicily which determined that children born of smoking mothers<~ii had a better survival rate than children born of non-smoking mothers. The editor of the journal refused to publish his study since it went against conventional wisdom. O'Neill concluded by having Ashford explain that he does not read and rely on review articles because they can be.~ prejudiced Even though review articles might save time, it is~ his scientific practice to go directly to the original papers. In five minutes of follow-up questioning, Sherman tried to suggest that Ashford's experience with the New England Journal ~ of Medicine was rare and that his study perhaps was not of high,~ quality. "Must a journal publish an article the editor thinks .is not well done simply to avoid being accused of publication bias?" Ashford replied that if the study was well done and found results.~ that challenged contemporary dogma, a good journal should publ~sh it. After Ashford concluded his testimony, the Judge again polled the audience to see if any of the missing speakers had arrived, but they had not. The Judge also announced that severally% speakers over the next two or three days have either cancelled~i their appearances or asked to be rescheduled. When the hearing began this morning, a look around audience showed that everyone present was in some way connected<~ with the tobacco industry. It can probably be expected that<..> unless major, well known tobacco industry witnesses are to',,'..~ testify, there will be little if any increase in attendance. I0969~61 51268 ,~.~ 80
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DATE: OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE November 15, 1994 REPORTER: WENDELL L. STONE SHOOK, HARDY & BACON The appearance of Stanton Glantz (one of OSHA° s witnesses on heart disease who testified in September), Matthew Myers (Coalition on Smoking or Health) and several plaintiffs attorneys (one of whom was involved in questioning and acknowledged a connection with Motley's law firm, and another of whom was overheard in the aisle to say he was with the "Motley group") at the opening of the hearings promised for a long day That promise was more than fulfilled, in that nearly the entire day, until 5:00 p.m., was taken with the testimony and cross- examination of a single witness, Maurice LeVois, Ph.D., whose testimony criticized claims that ETS is associated with increased heart disease risk. The questioning by the Motley attorney and by Myers was brief and uneventful. The reason for the protracted day was Sue Sherman, whose questioning (including assistance by Glantz) was for over three and one-half hours, with remarkably~'~ little if any, gain for OSHA's side of the record Scientific , . testimony was also given by Raphael J. Witorsch, Ph.D. (Medical College of Virginia), who challenged claims of an association of ETS exposure with various reproductive and neonatal effects. Two walk-ons at the end of the day testified about business and economic effects of the proposed regulations regarding smoking. The hearings were not adjourned until nearly 8:30 p.m. In view of the content of Dr. LeVois's testimony, namely ETS and heart disease, it is perhaps not surprising that Stanton.~..~ Glantz appeared at these proceedings As it turns out, Dr Glantz, who spent the minutes prior to convening the session talking in the aisle with Matthew Myers, Sue Sherman and other members of the OSHA panel, actually had a more formal role in"~. these proceedings then these casual interactions might indicate. At the opening of the session he took a chair at OSHA's table on the stage, at the right hand of Sue Sherman. During Sue Sherman's extensive cross-examination of Dr. LeVois, Dr. Glantz repeatedly wrote notes to her and whispered questions in her ear. This.~ practice continued until late in the morning, reaching a point when Ms. Sherman appeared confused about the sense or intent of a 1 51268
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question she was asking. She was forced to request that Dr take over and "clarify" the question for the witness. Then, at Pat Tyson's (Constangy, Brooks) insistence, it was clarified for the record that Dr. Glantz was questioning Dr LeVois on behalf of OSHA. Later in the afternoon, Glantz had his own series of questions for Dr LeVois. Dr. LeVois holds a Ph.D. which he received in 1984 from the University of California, San Francisco. His research for the Ph.D. specialized in questionnaire design and analysis. His primary affiliation is with a research organization, the Institute for Evaluating Health Risk, Washington, D.C. However, about 20% of his time is spent in independent consultant work through his firm, Environmental Health Resources, Tiburon, California. His statement was submitted on behalf of the Tobacco Institute. Dr. LeVois reviewed and summarized the data from 14 published epidemiological studies on ETS and heart disease, as well as reported his analysis of unpublished data from two major prospective studies by the American Cancer Society and another study based on data from the National Center for Health Statistics. Regarding the published heart disease studies, he highlighted a number of weaknesses, including the "extremely small numbers" of subjects, that most of them were not initially designed as ETS studies, that there was inadequate control of bias and confounding factors and that spousal smoking, in particular, introduces biases into such studies OSHA's calculations of heart • disease deaths associated with ETS exposure relied on a study based on a census survey in Maryland, published by Helsing, et al. The Helsing study suffers from serious methodological problems. In Dr. LeVois's view, OSHA's reliance on Helsing is "damning this whole literature with faint praise." Dr. LeVois then set up a series of five "standards" that would define an acceptable heart disease epidemiological study..~.~ i. The study should be large; 2. it should be prospective; 3. it should involve repeated measures of the main potential confounding factors; 4. there should be clinical diagnoses of the disease or death end points; and 5. there should be follow-up of ~ close to 100% of the cohort. When the epidemiological literature ~'~ on ETS and heart disease is evaluated with respect to these five standards, Dr. LeVois concluded that "no ETS study is adequate." Dr. LeVois singled out the Helsing, et al. study for :~ special consideration. Even though the Helsing study was large, .°~ there was a loss to follow-up of a substantial percentage of the participants, and Dr. LeV0is believes there is a case to be made that this follow-up would be differential in the exposed and nonexposed groups. Of further note is that the Helsing study"~ involved a statistical adjustment, in that before adjustment there was a 34% decrease in heart disease risk for ETS exposed women,-~ 2 S1268 24~2
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but following the adjustment there was a 24% increase in relative.~ risk. Helsing did not provide details of the nature of this~i statistical adjustment, and given this reversal of the direction of risk, Dr. LeVois believed that it would have been extremely important for this information to be provided. Dr. LeVois.,,~i considers it '~remarkable" that such a shift in direction was.~ reported by Helsing without explaining it. One of Dr. LeVois's central points was that research on ETa and heart disease risk probably shows a publication bias, meaning that there is a tendency only for studies demonstrating an association to be reported in the literature• One way he~ addressed this issue was through a statistical analysis, which he presented graphically, indicating that there is a relationship~qi between the relative risk in a study and the amount of variability..x~i in the study, suggesting that the worse the study was, the more~ likely it was to show an association with ETS and heart disease. If many of these studies were on any topic other than ETS they , -~ would not be published. The possibility of publication bias was further supported by examining the results of three very large databases..~j~ Two of these are from prospective epidemiological surveys ~ conducted by the American Cancer Society, referred to as CPS-I and CPS-II data on which he obtained from the law firm of Covington and Burlingo Using these data, Dr. LeVois calculated the relative risks in nonsmokers associated with the smoking habits of the spouses. He presented the following data. For CPS-I, the relative risk for nonsmoking men married to smoking women was 0.97, and for nonsmoking women married to smoking men was 1.03. Similar figures from CPS-II were, for men, 0.97, and for women, :~ 1.00. These relative risks, which are very near 1.0, and which~ had very wide confidence intervals, do not indicate an association~, of heart disease with ETa exposure. Dr. LeVois presented a~ variety of other calculations, combining the two studies, as well~ as grouping sexes. All of the comparisons were "essentially null" ~ with regard to a possible association of ETS with heart disease. • The third source of unpublished information regardlng~ ETa and heart disease was the National Mortality Followback Study.~ (NMFS) The NMFS is based on death certificate information from the National Center for Health Statistics. A 1% sample of deaths<u is periodically taken, then survivors of these individuals are.,~ interviewed for demographic and risk factor information, in a~ • manner very much like a case control study. When the data from.~ the NMFS were examined in terms of spousal smoking and heart~ disease, Dr. LeVois reported the following relative risks: for..~.~ nonsmoking men married to smoking women, 0.97; for nonsmoking..~ women married to smoking men, 0.99. Based on the CPS-I and II and~ NMFS, he argued that publication bias "clearly seems to be important factor" in the literature. 3 51268 2~3
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Following the completion of Dr LeVois's prepared statement at approximately 10:20 Sue Sherman from OSHA began an extensive cross-examination, which did not conclude until nearly 3:00 p.m Despite the length of this questioning supplemented • , late in the afternoon for an additional hour by Matthew Myer, Dr. LeVois emerged essentially unscathed, and probably strengthened. Dr. LeVois was a strong, articulate and well prepared witness. He was questioned in detail about the published literature on ETS and heart disease, as well as with regard to his analysis of the unpublished data from the two ACS studies and the NMFS, only serving to reinforce the impression of his strong command of this literature. Ms. Sherman opened with an inquiry into the nature of Dr. LeVois°s consulting business, but soon shifted to a series of questions, which she was later to repeat with Dr. Witorsch, as to Dr. LeVois's views on smoking as a cause of lung cancer and as a cause of heart disease Dr LeVois's position is that smoking is a "risk factor" for these diseases, but has not been shown to be a cause. Ms. Sherman attempted to twist this by suggesting that when a scientist says "risk factor," it is commonly what a layman would consider to be "cause " Part of Ms Sherman's cross-examination, and later that • by Dr. Glantz, related to criticism of the two ACS studies. Sherman and Glantz both seemed to ignore the fact that LeVois had never testified that the ACS studies or the NMFS study, although large, were necessarily otherwise methodologically strong. In fact, he had noted a number of problems in these studies, including problems relating to classification of ETS exposure on the basis of spousal smoking habits• Dr. LeVois was not arguing that these studies should be relied on, but that these studies are certainly no worse than the published studies and, in particular, not worse than those which OSHA relied on in its preamble to its proposed rule, including Helsing. In an exercise in pointlessness, Ms. Sherman questioned Dr. LeVois extensively concerning his summary table of the published studies on ETS and heart disease• She asked him to explain how each of the numbers was derived in a column in the table relating to exposed and unexposed subjects• Other details about this table were brought out, relating to which studies were abstracts which were dissertations, which were peer reviewed, which studies were the result of logistic regression (an area of questioning which Ms. Sherman had particular difficulty dealing with), which numbers were taken directly from the primary studies, which were taken from review papers and which were recalculated by Dr. LeVois. Whatever Ms. Sherman's intent in these lines of questioning, the ultimate result was that it demonstrated the high 4 51268 24~
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degree to which Dr. LeVois was well versed in the ETS heart disease studies.,~ Ms. Sherman also questioned at some length regarding the~ data Dr. LeVois provided regarding the CPS-I and CPS-II studies She wanted to know methods for calculating numbers. OSHA may be planning to perform their own calculations from the ACS data, because Dr. LeVois was requested to submit to OSHA the computer programs or at least detailed explanations for how the data were analyzed Dr. Glantz's questioning of Dr. LeVois began at <~.~ approximately 2:00 p.m. He attempted to obtain concessions from Dr. LeVois on a variety of points which Glantz himself has often voiced, including that Dr. LeVois (as an example of a tobacco ~.x~ industry consultant) sets up unreasonable standards for proving ~ causality, that publication bias is not really occurring and that confounding factors are not an explanation for the observed ETS heart disease relative risks On the confounding factors issue, following a similar technique used when Dr. Glantz himself had been cross-examined in illustrating the failure of the published ETS heart disease studies to control for the major heart disease risk factors, Dr. Glantz began a series of questions by the statement that he wanted to read a list of potential confounders. He wanted to obtain from Dr LeVois an indication of which were not considered in his CPS • analysis• Dr. LeVois immediately interjected, saying he could simply go back to the data table on the study, which shows which factors were included. Dr. Glantz would not be deterred, however, and then began a series of 33 questions, asking for example, whether Dr. LeVois's CPS data included controlling for whether the father was dead; whether the mother was dead; whether the subjects were divorced, separated or widowed; household size; whether the person was not in paid employment; whether the subject was ~ employed at an occupation with a possible heart disease risk; low income; alcohol consumption; does nothing to keep healthy; does not get much exercise; never tried to lose weight; had nervous or depressive illness; slept greater than seven hours; waited two ~ hours or more after getting up before the first meal; ate more.,:~ than four slices of bread per day; fruit intake; low vegetable intake; low salad intake; sugar intake in tea or coffee; doesn't use margarine; overweight or obese; does not cut down on fat; ~5 neurotic behavior; extroverted behavior; Type A behavior, etc. After finishing this list, Dr. Glantz then asked whether Dr• ~ LeVois thought his failure to include these factors in his~ analysis of the CPS-II data was a problem. Despite the entertainment value of this well prepared exercise by Dr. Glantz, it got him nowhere, except to allow Dr. LeVois to reiterate a point he had been making all along namely that whatever effect not including these factors would have would be no more of a
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criticism than would be applicable to the literature on which OSHA relies. Dr. Glantz also tried to approach the confounder issue from the perspective of Judson Wells, another OSHA witness who had testified earlier in these proceeding. Wells had argued in a recent publication that when the ETS heart disease studies are classified according to the number of risk factors controlled for, then those which have controlled for more risk factors show higher degrees of relative risk. Dr. LeVois described this as a "completely nonsensical" approach, given that none of the ETS :<~ heart disease studies deal with more than a few variables, and even those few that are addressed are not controlled adequately. Matthew Myers set the tone of his cross-examination Dr. LeVois with an opening question of: "When did you first take money" from the tobacco industry? Dr. LeVois first provided services to the tobacco industry in 1987 or 1988 when he covered a conference in Montreal. He has also provided several reviews for ~ the Tobacco Institute, including reviews of the EPA risk assessment, provision of information at a California meeting on ETS and heart disease, earlier written testimony for OSHA, a labor /~ meeting for the state of Washington and testimony before Congress on two occasions. He has met with tobacco industry lawyers on several occasions for briefing. He has been paid for his reviews and is being paid for his time here. He had not performed any tobacco related research or reviews until he became involved with the tobacco industry. Mr. Myers attempted unsuccessfully to demonstrate that the only conclusions that Dr. LeVois has ever reached in his consultancy activities have been those that he has been paid to provide. Mr. Myers delved briefly into potential company research. Dr. LeVois said he had not asked the company for any~ research they may have done on smoking. Mr. Myers referred to~~ Philip Morris testimony earlier this year which related to a nicotine substitute which would eliminate the adverse effects of-<~ nicotine on the body. Mr. Myers wondered whether that testimony , had prompted Dr. LeVois to ask for that data. Dr. LeVois s~mply said no. Mr. Myers also addressed the conditions under which he had received the CPS-I and CPS-II data. Dr. LeVois had received these data from Covington & Burling, but does not know how that"~ law firm obtained these data. C&B provided raw data tapes as welli~ as code books for the use of these tapes. Dr. LeVois did not~ consult with anyone at the ACS regarding these data. C&B placed~ no restrictions on him with regard to any analysis that he might/'~ do and he was told that it would be permissible to publish the results of his analysis.
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Under questioning by Myron Weinberg (WashTech) Dr...~ LeVois elaborated on the importance of his point that loss subjects to follow-up, such as in the Helsing study, is important~'~ because such loss is rarely random, and as a result, may result in losing some of the most important information in a cohort study. Questioning by John Rupp (C&B) strengthened Dr. LeVois' ~ point that in the Helsing study, age is the only major risk factor~~i that was controlled. Furthermore, the Helsing study did not have !~ workplace data. Dr. LeVois had not been asked about workplace,~i data by anyone on the OSHA panel, but had done an analysis of ETS/heart disease workplace studies. That analysis is part of his<,.~i submission to the record. The Helsing study is no better than the CPS-I or CPS-II or NMFS There is no reason to rely on Helsing over these others. It was already after 5:00 before Raphael Witorsch took the stand to give his testimony. Dr. Witorsch is a professor of.~ physiology at the Medical College of Virginia, Virginian Commonwealth University, Richmond. He specializes in endocrinology, particularly reproductive endocrinology. He stated.~ that his comments were submitted at the request of Covington Burling on behalf of the Tobacco Institute. He addressed the section of the proposed rule which dealt with reproductive toxic effects of ETS, with particular reference to four statements by OSHA on such effects. First, OSHA claimed that there are many studies on reproductive effects of ETS exposure in pregnant women. Dr. Witorsch argued, however, that most studies cited by OSHA actually relate to effects attributable to active smoking by the mothers. Second, OSHA claimed that ETS exposure is associated with low birth weight. However, Dr. Witorsch believes that other factors are involved, particularly active smoking, but also noted alcohol consumption, birth order and maternal age, among others. There are 32 studies which have examined ETS exposure and low birth weight, the majority of which have failed to show a statistically significant association. This suggests, in Dr. Witorsch's view, that any effect of ETS is below the threshold for the effect seen with active smoking. Third, OSHA claims that ETS exposure is.~ associated with miscarriage, congenital abnormalities and other physiological effects. In connection with this claim, Dr. ~ Witorsch reviewed the seven available studies on ETS effects on.~ still births, spontaneous abortion and miscarriage. Five of theseo~ reported no association with ETS exposure. He reviewed three studies dealing with perinatal and neonatal mortality, the data~ from which were paradoxical and mixed, as well as being very old, all from the early 1970s. On the issue of congenital abnormalities, he reviewed six available studies, mostly which reported nonstatistically significant results. The fourth OSHA 7
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claim addressed by Dr. Witorsch was that ETS exposure in many have adverse long term effects, including effects into childhood and adulthood, including cancer. He reviewed 13 papers on maternal ETS exposure and later cancer in the offspring. None these reported a statistically significant increased risk for the endpoint cancer of all types. His primary conclusion was that "there is no compelling evidence" that ETS exposure of the mother poses a risk to the fetus. Ms. Sherman opened her questioning into an inquiry into the nature of the firm, Center for Environmental Health and Human Toxicology (CEHHT), which is on the letterhead of Dr. Witorsch's request to appear at these proceedings. CEHHT is a consultant organization which Raphael Witorsch is associated with through his brother Philip Witorsch. He subcontracts with CEHHT approximately 20% of his time. His other tobacco industry .~ testimony has included participation in the California EPA proceedings, as well as a court case for which he provided telephone deposition. He has also worked with his brother on a review of ETS exposure and respiratory illness and pulmonary dysfunction in children. All of his work in the area of tobacco has been supported by either the Tobacco Institute or Philip Morris. He has done no primary studies on ETS or active smoking and has been involved in only "very limited" study of the pulmonary system, until his work for the tobacco industry. .Ms. Sherman inquired as to whether there was a "safe level for the carcinogens found in cigarette smoke." Dr. Witorsch agreed that there was, commenting generally that for most carcinogens, there is a threshold. After a series of questions relating to middle ear infections and mechanisms of low birth weight, Ms. Sherman returned to the issue of threshold, obtaining~{~ weak acknowledgment that there might be a threshold for the minimum amount of time a pregnant woman would need to smoke in order to have the low birth weight effect, or the minimum amount~.~ of hypoxia to get the low birth weight effect. The only questioning by a plaintiffs' litigation firm did not begin until nearly 6:30. A person named Susan Dial (sp?) approached the podium and said that she represented Motley's firm"-~ and was appearing on behalf of the American Medical Association, ETS "victims," Virginia GASP and others. Her questioning was for slightly longer than half an hour. She inquired into the nature of Dr. Witorsch's consulting organization and its clients. "~t~ Raphael Witorsch actually has no independent tobacco clients. His~ brother Philip contacts Raphael, who then asks about time~ availability and arranges the consultancy. During Ms Dial's questioning, it was brought out that with regard to his testimony at these hearings, Dr. Witorsch had 8
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met with the Covington & Burling people yesterday, but had..~ prepared his testimony without their help. They may have seen his testimony, but so far as he could tell, they had made no changes in it. Ms. Dial asked whether Dr. Witorsch had ever had funding from the "CTR Special Projects Group." Dr. Witorsch said that he had not. Throughout the questioning, despite Ms. Dial's highly accusatory tone, Dr. Witorsch effectively defended his objectivity, arguing that "you do not do a client a service by telling them what they want to hear." It was after 7:00 p.m. before the testimony of two "walk-ons" began. The first of these witnesses was Paul R. Wall, vice-president of Philips Sea Food Restaurant, Ocean City, Maryland. He has several restaurants, three in Ocean City, but also restaurants in Baltimore, Washington, D C Norfolk • -, , Virginia, Tyson's Corner, Virginia, as well as hotels in Ocean city and in West Palm Beach, Florida. In a friendly story-telling manner, he described his history with and growth of the Philips Restaurant organization. Philips does about $40 million in business. Mr. Wall did an informal survey of all his general ~i~ managers, asking them what they thought would be the effect if <~"~ OSHA prohibited smoking. His managers said there would probably be a i0 - 20% decrease in business. Currently, smoking and nonsmoking sections are "working beautifully." The customers are happy, because they are getting what they want. Waitresses actually prefer to work in smoking sections, because the tips are better. Mr. Wall's restaurants also provide services regularly to Japanese group tours, who are very concerned about smoking issues. Ms. Sherman's questioning was a routine series which she has been asking business witnesses opposing the rule, particularly where they heard about the rule, whether they have read it, the~ nature of ventilation and filtration in their businesses, ~~ maintenance, and smoking related complaints. Mr. Wall had also opposed the action on smoking by Maryland OSHA. Mr. Wall.~ acknowledged that the Maryland Restaurant Association was against the IAQ portion of the Maryland OSHA rule but not the smoking part of that rule. However, under questioning by David Smith.~ (Constangy, Brooks) Mr Wall pointed out that although some , • Maryland restaurateurs may have thought the smoking/nonsmoking area practice was "confusing," there are many other restaurant.$~ owners in Maryland who are opposed to the Maryland OSHA smoking"~ rule. The final witness of the day was Wayne Chappell, ~..~ executive director of the Baltimore Area Convention and Visitors..~ Association. He spoke out against the smoking portion of the proposed rule. He was aware of this rule because of its similarity to the recent Maryland OSHA action. His main reasons
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for opposition were that it would, first, result in damage to travel business from visitors from outside the U.S. and, second, would create difficulties in enforcement On the first issue there are 47 million annual visitors to the U.$. from foreign countries, and many of these people would simply not come if faced with a no smoking rule, resulting in a possible loss of billions of dollars, as well as "lots and lots of jobs." On the issue of difficulty in enforcement, he described how a hotel room becomes a person's "home." It is not practical or reasonable to tell a person that he cannot smoke there. Furthermore, what if a person smokes despite a no smoking rule by OSHA and then an employee goes into that hotel room. Does that mean that the hotel owner is subject to a fine? The hearing was adjourned at approximately 8:25 p.m. and will reconvene tomorrow at 9:30, with the scheduled testimony from three scientists, A. Springall, Paul Switzer and Thomas Starr. i0
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DATE: OSHA HEARING REPORT PRIVILEGED AND CONFIDENTIAL ATTORNEY/CLIENT PRIVILEGE NOVEMBER 16, 1994 REPORTER: WENDELL L. STONE,.~i SHOOK, HARDY & This was an exhausting day of hearings following an~ exhausting day of hearings, in what appears to be becoming pattern of tedious, unproductive questioning of scientists~ testifying on behalf of the tobacco industry. Although the~ session opened with relatively brief testimony from representative of a business which sold air cleaning and~ ventilation systems, almost the entire day was dominated by the~ testimony of two statistical consultants; Anthony Springall (Avon,<~ England) and Paul Switzer (Stanford University). Dr. Stanton Glantz was back at the side of Ms. Sherman. ~ Four or five plaintiffs' litigation attorneys were present as~ well, but only one questioned the scientists, usually to no great~ effect. One of the attorneys was surprised when Dr. Springall had'~ recognized that she was probably the person who had called him~ under false pretense to obtain his C.V. Ms. Sherman's questions to the scientists have taken one. a redundant tone often inquiring into opinions concerning the main~ industry themes of confounding and misclassification, andt~{~ laboriously plodding through the written statements seeking~ • , h additional information or clarification More often than not er.~ questions have primarily served to strengthen the scientist' testimony, and to lengthen the hearings, which adjourned at just~ before 8:00 p.m. today and that was after the postponement ofone scheduled scientific witness until tomorrow. The opening testimony was given by Raymond Warrick. Mr. Warrick gave a 15 minute presentation on the effectiveness of air~ 0 cleaning systems in dealing with smoking. He represented Unite~ Air Specialists, which makes air cleaning and control systems,~.~ most notably electrostatic precipitators for particulate removal, although his filtration devices also have a carbon component that~i{ reduces levels of some gaseous components of indoor air. 1
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Mr. Warrick is "generally supportive" of OSHA's efforts in the IAQ area, but believed that the current proposal "could use a little fine tuning " He was especially concerned about OSHA's failure to provide threshold limit values that would set targets to work toward in terms of improving IAQ. Mr. Warrick considered the documentation of ETS effects in the proposed rule to be "excellent," but expressed specific concern about not having a threshold limit value for ETS. Mr. Warrick also discussed certain flaws in OSHA's analysis, relating to determination of necessary ventilation rates for a smoking room, which OSttA has "consistently underestimated." ~.. He also discussed practical problems in establishing separate HVAC systems for smoking rooms, as well as the issue that such rooms could expose smokers to heavy concentrations of ETS. His general perspective, not unreasonable from the point of view of a businessman selling air filtration and control devices, was that it was possible to have effective control of ETS via air cleaners and ventilation/dilution Before the scientific testimony began Pat Tyson took the podium and noted for the record that he found it "very very /~ troubling" that Stanton Glantz served on the panel representing OSHA in asking questions, especially in view of the fact that OSHA 2 has repeatedly stated that it had an open mind on these issues, contrasted with Stanton Glantz who has a clear anti-smoking position. For the record, Ms. Sherman said that the panel did, in fact, have an open mind and that it was appropriate to have Glantz, with his expertise in the area, to assist in asking questions. Mr. Rupp endorsed Tyson's statement, noting that it was no more appropriate to have Glantz represent OSHA than it would be to have the Tobacco Institute represent OSHA. Mr. Furr joined with Mr. Rupp and Mr. Tyson for the record. The first scientific witness of the day was Anthony.~ Springall, a British statistician. He has a Ph.D. in statistics from Virginia Polytechnic Institute, and has worked for the Unilever Company, Imperial Tobacco and the University of the West of England. Since 1991, he has been an independent statistical,~ consultant. Dr. Springall was requested by Philip Morris present his views. His main points were that the 16 lung cancer and 5 heart disease epidemiological studies that have examined exposure to ETS in the workplace "provide no evidence" that such exposure "is associated with or causes either disease." With • regard to 18 lung cancer epidemiological studies which have considered childhood exposure to ETS, "these studies do not support an elevated risk." With regard to the 39 lung cancer and 14 heart disease epidemiological studies that have examined ;~i spousal smoking, these studies do "demonstrate slightly elevated~ relative risks." These elevations, however, "can be entirely accounted for by study biases," most particularly smoker 2
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misclassification and lifestyle differences between nonsmokers married to smokers and those married to nonsmokers. Ms. Sherman opened questioning with an inquiry into Dr. Springall's qualifications and his tobacco industry connections. She first asked what type of research he did for Imperial Tobacco but he said this was "proprietary," and she did not follow-up. He was at Imperial Tobacco for 17 years, 1971-1988. He has read the literature on the health effects of ETS, but has performed no research. He has not done any studies on ETS and heart disease, nor published any review articles on this, other than for the EPA and OSHA, but these are not peer reviewed. In a somewhat novel line of examination from Ms Sherman, she posed a series of questions that might be asked of subject in an ETS study, asking Dr. Springall to answer them as would personally. These questions related to whether Dr. Springall smoked, when he started, when he quit, was he married, for how long, did his wife smoke, and so on. At the conclusion of .~ several questions, Ms. Sherman stopped and asked Dr. Springall whether he was "very confident" in his answers. He acknowledged that he was Then, she asked a series of questions relating to ETS exposure at work, whether people smoked in his iI~ediate work area, while he was at Imperial Tobacco, how many hours per day he was exposed while at Imperial Tobacco, while at the University of the West of England, etc. She asked whether he thought his recollections of ETS exposure were more reliable for work than with regard to home. He said that the workplace recollections were less reliable, because he knows that his wife didn't smoke He does not, however, consider his ability to recall ETS exposure at work versus at home to be necessarily typical, since the reverse might be true if his life were different. Generally, however, he~ acknowledged that a person would have a more accurate recall of home (spousal) exposure than workplace exposure. Ms. Sherman then initiated a series of questions relating to misclassification methods, essentially allowing Springall to effectively emphasize the importance of this issue. At 12:00, Judge Vittone stopped Ms. Sherman, determined that she,~ had another hour of questioning left, and there was a break for lunch Rather than continuing with Dr. Springall's cross-.~!~ examination following the lunch break, Judge Vittone allowed Dr. '~! Paul Switzer to take the stand in order to accommodate his flight..~ schedule, with Springall's cross-examination to continue later in the day. Paul Switzer, Ph.D., is professor of statistics and applied earth sciences, Stanford University, Stanford, California. He received his Ph.D. from Harvard University and has a principal research interest in statistical methodology as applied to environmental problems. He presented his testimony at the request
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of the Tobacco Institute and focused his remarks on the issue of claimed lung cancer risk associated with exposure to ETS in the workplace. Dr. Switzer argued that OSHA had not considered all of the relevant epidemiologic studies in evaluating lung cancer risk from workplace exposure to ETS, that the EPA's evaluation of lung cancer risk was flawed that the data cited by OSHA do not demonstrate a significant lung cancer risk associated with ETS exposure in the workplace and that there are various flaws in OSHA's estimate of annual lung cancer risk, as well as in OSHA's assessment of occupational ETS exposure. Dr. Switzer opened with a criticism of the EPA's risk assessment on lung cancer, which had concluded that there were 3,060 annual lung cancer deaths associated with ETS exposure in U.S. nonsmokers and former smokers. However, the epidemiologic data used in arriving at this calculation were all based on female spousal smoking studies. Only 470 out of the total of 3,060 lung cancer deaths were actually from this group. The remaining 2,590 lung cancer deaths were calculated through a series of ~ extrapolations, relating to exposure estimates, dose response and other issues. The majority of lung cancer deaths claimed by the EPA to be associated with ETS exposure, in fact 72%, were assigned to so-called "background exposure." Dr. Switzer considered it "laughable" to say, as the EPA did, that their confidence in the estimate was "medium to high." Dr. Switzer then proceeded to provide testimony on specific criticisms of the 1992 EPA report, relating to its statistical methodology, sources of systematic error and other issues. He also listed criticisms of the 1994 Fontham study, relied on by OSHA for its lung cancer death calculations and criticisms of OSHA's interpretation of the California Activity Pattern Survey, which OSHA used to base ETS exposure claims. Dr. Switzer's criticisms of OSHA's risk assessment covered weaknesses in the Fontham study, improper use of the study by OSHA, problems ~ with definitions and that the data used by OSHA regarding workplace ETS exposure, and OSHA's use of unstated assumptions, exaggerated the agency's calculations of the 45 year lung cancer ~ risk. One of Dr. Switzer's central conclusions was that OSHA should have used the workplace studies in its evaluation of lung cancer risk. The fact that OSHA did not use these studies, in Switzer's view, was because these studies do not show an"~.~ association. Following Dr. Switzer's 40 minute presentation, Ms. Sherman spent approximately the next hour and a half questioning Dr. Switzer about his specific criticisms of the ETS lung cancer literature and exposure data, as set forth in his written statement. During most of this time, Ms. Sherman received the.,.~
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assistance from Dr. Glantz, via notes and whispers, who sat on her right. Although she inquired in areas such as Dr. Switzer's views on the adequacy of meta-analysis, problems in workplace studies,.~:~i misclassification and confounding, he effectively defended his Dr. Glantz, for a ten minute period of questioning, also picked up on the issue of confounding. He inquired whether it would create any problems if a study attempted to take into account several different potential confounding factors all of which were correlated. Dr. Switzer acknowledged that it could..~I create problems in the stability of the regression coefficients and could mask an ETS effect under some conditions. At approximately 3:30 a plaintiffs' litigation attorney, Michael Gertler, identified his appearance on behalf of o~ certain labor unions, health organizations and ETS "victims." He appeared with a female associate, later determined to be Marsha.~i Finkelstein, who helped him with paper at the podium. Mr. Gertler's questioning immediately turned to Dr. Switzer's\~'~ background, especially in relation to his tobacco industry work and views concerning smoking and disease. Dr. Switzer ~.<~ acknowledged his consultation work for the Tobacco Institute and<~ that he had provided comments on draft versions on the EPA report in 1991 and 1992. He has read that ETS contains carcinogens, but is not competent to comment in that area. Whether or not something contains carcinogens may or may not have public health significance. He has no independent conclusion on this issue, and can only repeat what he has read. He does not consider there to be an overwhelming opinion in the scientific literature that ETS contains carcinogens at sufficient levels to be of public health'~ significance. With regard to the issue of active smoking, he said~ there was a "strong enough association" of active smoking and lung~ cancer, such that he would take that association into account in a decision to smoke. However, he has not reviewed the epidemiological literature relating to active smoking. He can't~ offer a professional opinion as a statistician, because:~ statisticians don't deal in causes. The Tobacco Institute has never asked him to do any original research on ETS and health effects. He reports to the Tobacco Institute through an attorney. He occasionally provides"~ • critiques of articles in the literature for the Tobacco Institute. i~ Mr. Gertler then moved into the area of how much money Dr. Switzer~ has received from the Tobacco Institute. Referring to deposition in a 1993 case involving the regents of the University ~ of California, he cited a statement that Dr. Switzer had been paid perhaps $75,000. At this point, Judge Vittone stopped Gertler and gave a five minute speech setting up ground rules on this issue. 5
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Judge Vittone opened by saying that "maybe I should~i explain" that although it may be relevant who sponsored an individual or asked them to provide testimony, it is not relevant to go into how much money was paid or the details of the.~.~i relationship, "just like I don't think it's relevant to go into every anti-smoking meeting Glantz went to." Judge Vittone said he wanted to get back into the subject of IAQ. The details of payment simply don't advance the record. This is "not a trial, not litigation, not a court action of any kind." What is relevant is whether the testimony is "reasonable" and whether it is "supported." Judge Vittone emphasized that he did not want.to~tl spend much time on this subject, pointing out his guiding principle that "I ~o not want people to be discouraged from coming into this hearing. Clearly Judge Vittone was concerned that this sort of adversarial questioning could have this effect. Mr. Gertler accepted the Judge's admonishment, dropped..~l that line of questioning, then moved into the area of misclassification and confounding. It was after 5:00 p.m. before Dr. Springall returned to/~ the witness table. Ms. Sherman, following the tedious method from'~ the morning, continued to plod through Dr. Springall's written statement, asking for clarification and detail about various items. Much of this discussion related to Dr. Springall's view "of the Fontham study, an area of questioning which seemed of no use to OSHA at all, and in fact provided an opportunity for Dr. ~.~ Springall to reiterate various criticisms of the Fontham study, including issues relating to misclassification, inadequacy in the controls, lack of representativeness and inadequate details~ concerning the data. Dr. Glantz also questioned Dr. Springall for approximately 40 minutes, in what quickly became a contest in the~.~ use of statistical jargon. One of Dr. Glantz's recurring themes is the issue of confounding variables that are correlated. In Dr. ~5 Glantz's own testimony, he had argued that a single factor, such as socioeconomic status, could control for a variety of different~9~ factors that were correlated with it, including education, perhaps diet, and a number of other factors. Thus, there is no need to control for all of these other factors. Dr. Glantz asked Dr. Springall to explain what problems would, arise from including correlated variables in a regression analysis which is the • problem called "multicolinearity." Dr. Springall acknowledged~ that it could sometimes result in "badly structured data." Another major area of Dr. Glantz's questioning focused~'~ on what Dr. Springall had called °'Vandenbroucke plots.""~"~ Vandenbroucke plots are graphs which show the relationship between<~ the variability in a study and the relative risk. The symmetry, 6
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or lack of symmetry, provides an indication of potential publication bias. This technique, which had also been used by Dr. LeVois yesterday (Dr. LeVois had called these funnel graphs) was introduced into the scientific literature by an individual named Vandenbroucke, from which the technique derives its name. Dr .... Glantz attempted to show that this technique was not widely used in the literature Dr Springall pointed out that it was a new technique, so obviously there wouldn't be much literature on it. With a feisty reply to Dr. Glantz, characteristic of Dr. Springall's confident testimony, he rhetorically asked: "are you suggesting that we only use old techniques?" Dr. Glantz would not leave this issue alone, attempting to demonstrate that Dr. Springall's conclusions from the use of these Vandenbroucke plots were basically just guesses from how the data appeared on the plots, and did not actually involve a statistical test. Dr. Springall said that these plots were really a descriptive technique, and in a case such as this, a statistical test is not needed, because the data speak for themselves. However, sometimes a statistical test for trend, as was done for on the LeVois data given yesterday, is appropriate. Mr. Gertler then rose to question Dr. Springall, asking about research that Springall may have done regarding tobacco and health effects. Springall did not answer, claiming that this information was "proprietary," and Mr. Gertler did not push the issue. Following up on Dr. Glantz, Mr. Gertler also addressed th~ issue of publication bias, with particular reference to the Vandenbroucke plots, in an unsuccessful attempt to demonstrate that Dr. Springall's use and conclusions from these plots differed from those by Vandenbroucke. Testing the seriousness of Judge Vittone's earlier admonishment, Mr. Gertler began to ask about consultancies Dr Springall may have had with the tobacco industry, other than his former employment with Imperial Tobacco. After three or four questions relating to his appearance at these proceedings on behalf of Philip Morris, Judge Vittone cut him off. In the context of questions regarding his background, Dr. Springall took the role of questioner and confronted Gertler with the question of "I can see you looked into my background." Then, looking at the female assistant who was sitting beside Gertler, said "so you must be Marsha" who called me regarding my C.V. Springall looked at the Judge, asking whether he could "bring this up." Tony Andrade approached the Judge and said he would bring this matter up in his own questioning. Later, during questioning by Bernie O'Neill, it was brought out that this attorney, Marcia Finkelstein, had called Dr. Springall last week, requesting expert help in asbestos litigation, and wanted a curriculum vitae in a hurry. Dr. Springall characterized this as "appearing to be an attempt to get information under false 7
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pretenses." Interestingl~, at the termination of Mr. Gertler's questioning, and before Mr. O'Neill had the opportunity to bring this information out Mr Gertler and Ms Finkelstein left the hearings room. One plaintiff's litigation attorney sitting with this group remained to the close, however. Mr. O'Neill also provided the opportunity for Dr. Springall to note that the Vandenbroucke technique was published in the British M~dical Journal, which is peer reviewed, and that Dr. Springall holds to his original interpretation of the Vander~broucke plot .... Referring back to the series of questions Ms. Sherman had asked Dr. Springall in the morning, regarding his smoking history, that of his spouse and his exposure to ETS in the workplace, Dr. Springall acknowledged that he very well may have felt more accurate and confident in his responses because he had been working in the area and had been thinking about this issue. He was probably in a position to recollect better and more firmly than the average working person. John Rupp also had some remaining series of questions, one of which provided the opportunity for Dr. Springall to express the opinion that the three very large unpublished studies (which were the substance of Dr. LeVois' testimony yesterday) provide "dramatic" evidence of publication bias The hearings closed at slishtly before 8:00 p.m. Dr. Thomas Starr, scheduled for today, has been rescheduled and will be the first witness up on Thursday. Also scheduled to testify is Maxwell Layard, a statistical consultant, and Mike Shell, of Telaire Systems. The hearings will start at the normal time of 9:30. 8

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