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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~

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 :~'~

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

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

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.

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

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

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 "~

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~

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 ~