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SHOOK, HARDY& BACON REPORT ON RECENT ETS AND IAQ DEVELOPMENTS June 25, 1993

REPORT ON I RECENT ETS AND IAQ DEVELOPMENTS - IN THIS ISSUE - • Tobacco interests file suit against EPA, p. 1. • U.S. Supreme Court decides MdGnnefi p. 8. • Deskicwicz is decided in favor of Philip Morris, p. 9. IN THE UNITED STATES REGUTATORY AND LEGISLATIVE MAT'TERS • EPA fails to replicate Anderson carpet study, P• 2. • PRO-FEDS bill advances through commit- tees; goes to full house, p. 3. • Clinton administration negotiating for international airline smoking ban, p. 4. • Postal workers file grievance after smoking ban imposed, p. 5. • Los Angeles City Council votes in favor of restaurant smoking ban, p. 5. ETS-RFIATED LI"IIGATION AGAINST CIGARETTE MANUFACTURERS • CEO depositions are stayed in Broin, p. 7. • Butkr set for trial in September 1994, p. 7. OTHER DEVELOPMENTSIMEDIA COVERAGE • AMA adopts resolution supporting bans, p. 11. • "Magic Carpets,'° p. 11. • "Health Agency Investigates Airplanes and TB Infections," . 11. SCIENTIFIClTECHNICAL ITEMS ISSUE 50 • "Passive Smoke Exposure During Preg- nancy: A Rodent Model," p. 12. • Six new studies on respiratory diseases and conditions in children, p. 12. IN EUROPE & AROUND THE WORLD REGULATORY AND LEGISLATIVE MATTERS • Austrian government officials reach agree- ment on tobacco legislation, p. 14. • Workplace smoking,ban is endorsed by EC Commissioner, p. 15. OTHER DEVELOPMENTS/MEDIA COVERAGE • Physician in Egypt calls on colleagues to stop smoking around patients, p. 14. • Swiss tobacco industry launches accommo- dation campaign, p. 15. • In the U.K, smoking is banned in all NHS hospitals, p. 15. •"By Order: No Smoking in Fumess," p. 15. m ~ 4D a CA Gn N

- TABLE OF CONTENTS - Issue 50' June 25, 1993 IN THE UNITED STATES REGULATORY AND LEGISLATIVE MATTERS U.S. ENVIRONMENTAL PROTECi7oN AGENCY (EPA) [1] Special Report: Suit Against EPA Seeks to Nullify ETS Risk Assessment ................................. 1 [2] EPA Fails to Replicate Anderson Carpet Study Results ............................................................2 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICEs (HHS) [3] HHS Revises Draft Executive Order on Smoking ....................................................................2 VETERANS ADMINISTRATION (VA) [4] Costs Estimated for VA Compliance with Smoking Standards ................................................3 103D CONGRESS [5] Traficant Bill Approved by House Committee .........................................................................3 [6] Capitolhrchitecc To Announce Smoking Plan ........................................................................3 [7] House Preparing Legislation to Improve Risk Assessments ......................................................4 WHITE HOUSE [8] Administration Seeks Smoking Bans on International Flights ..................................................4 [9] Health Task Force Member Anticipates Federal Workplace Smoking Ban ...............................4 U.S. OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA) [10] Labor Secretary Advocates Speedier Rulemaking .....................................................................4 U.S. POSTAL SERVICE [11) Post Office Smoking Ban Challenged ......................................................................................5 U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC) [12] Joint Project Initiated to Study HVAC Systems and IAQ .....................................................•••5 STATE AND LOGL GOVERNMENTS [13) ETS-Related State and Local Legislation ..................................................................................5 ETS-RELATED LITIGATION AGAINST CIGARETTE MANUFACTURERS [14] Blanchard Hearing on Venue Motions to be Held on July 1 ...................................................6 [15] Broin: Rehearing Petition Filed; Depositions of Executives Stayed ......................................•....7 [16] Butler: Trial Date Set for September 5. 1994 ...........................................................................7 [17) Dunn: Defendants Granted Extensions to Respond to the Complain...................................... 8 [18] Uoth: Motion to Dismiss Filed .................................................................................................8 ETS/IAQ LITIGATION'NOT INVOLVING CIGARETTE MANUFACTURERS PRISONER CASE [19] Special Report: 1Yclling v. MclCnnry; 1993 WL 209628 (U.S. Supreme Court) (decided June 18. 1993) .................................................................................................... ......8 Woltla'LACE: CoL1ECfIVE BARGAINING [20] In the matter of Tyndall Air Force Bart. F/orida and Loca13290, American Federal ofGover»mentEmployea. AFL-CIO, 1993WL 184118 (Federal Service Impasses Panel) (decided May 25. 1993) ................................................................................................9 WORIQ'IACE: IAQ/SICK BUILDING SYNDROME [21] Weekley v. lrtdusnia! Commistion. 1993 111. App. LEXIS 866 (Second District Appellate Court, Illinois, Industrial Commission Division) (decided June 9. 1993) ...........•.--••--•.••-........9 LEGAL ISSUES AND DEVELOPMENTS [22) Special Report: Washington Court Denies Reimbursement of Former Smoker's [23] Alleged Quitting Expenses .................................................................................................... ...9 "Smoke Alarm," E. Hopkins. Mirabella, July 1993 ................................................................10 OTHER DEVELOPMENTS [24] Michigan Malls Rely Upon EPA Risk Assessment to Support Smoking Ban .......................... 10 [25] Kansas City Area Joins Debate Over Smoking in Public Places ...........................•.-••-..•...•......10 [26] Smoking Cessation Program Aims to Create Smoke-free Environment .................................. 10 (27) World Bank Employees Vote to Ban Smoking ......................................................................10

Contents Continued, Issue 50 [28] Los Angeles County High School Speech Contest Asks "Should Smoking be [29] Banned in Public Places?" .................................................................................................... ..10 AMA Supports Legislation Banning Tobacco ........................................................................ I I MEDIA COVERAGE 1301 "Magic Carpets," T.W. Orme, Ph.D., Priorititt, Winter 1993 ............................................... 11 [31] "Times Just Says No to Tobacco Advertising - Evidence of Danger'Overwhelming;'"'S. Wieland:Nogaki and H. Gupta, ThrSeattle Tfnur, June 14, 1993 ......................................... 11 [32] "Health Agency Investigates Airplanes and TB Infections," M. Tolchin, The New Yo.k Times, June 21, 1993 ......................................................................................11 SCIENTIFIC/TECffiVICAL ITEMS LUNG CANCER [33] "Meta-analysis of Epiderniological Studies of Carcinogenesis," J. Pero. In: Mechanisms ofCarrinogertesis in Risk Idrntifrcation. H. Vainio, P.N. Magee, D.B. McGregor, and A.J. McMichael (eds.)i Lyon, Intemational Agency for Research on Cancer, 571-577, 1992 [See Appendix A] ..........................................................11 RESPIRATORY DISEASES AND CONDITIONS - CHILDREN [34] "Snoring, Sleep Disturbance, and Behaviour in 4-5 Year Olds" ............................................. 12 [35] "The Relationship of Nasal Disorders to Lower Respiratory Tract Symptoms and Illness in a Random Sample of Childten,* M.B. Barr, S.T. Weiss, M.R. Segal, I.B. Tager, and F.E. Speizer. Pediatric Pnlmonology 14: 91-94, 1992 [See Appendix A] ......... 12 (36] "IncreuedInBuencrof Passive Smoking on Hospitalization for Respiratory Disease in Low Birthweight Infants," Y. Chen„S.L. Home, and JA. Dosman, American Review ofRrtpiratory Disease 147(4 Part 2): A213, 1993 [See Appendix A] ............. 12 [37] "EfSectss of Early Vs. Late Environmental Tobacco Smoke Exposure on Pulmonary Function in Children," J. Cunningham, D.W. Dockery, and F.E. Speizer, American Review ofRetpiratory Disease 147(4 Part 2); A213, 1993 [See Appendix A] ............................ 12 [38] "Parental Smoking and Respiratory Problems in Childhood." J.-A. Evans and J. Golding. In: Effects of Smoking on the Fetus, Neonate and Child. D. Poswillo and E. Alberman (eds.). Oxford, Oxford UniaerrityPren, 121-137, 1992 [See Appendix A] ......... 12 [39] "Eight-months Incidence of Acute Respiratory Infections and Involuntary Smoking in Adolescents," D.B. Teculescu, E. Rebstock, Q.T. Phamj A.D. Cor1an, and J: P. Deschamps, American Review afRerpiratory Disease 147(4 Part 2): A134, 1993 [See Appendix A] .................................................................................................... ......12 RESPIRATORY DISEASES AND CONDITIONS -ADULTS [40] "Sidestream Tobacco Smoke (SS) Alters Regional Nasal Mucociljary Clearance: Comparison of Sensitive and Nonsensitive Subjeccs," J. Nadarajah, R. Bascom, T.K. Fitzgerald, M. Bickert, K. Cheng, T. Permutr, and D. Swift, American Review ofRespiratory Disease 147(4 Part 2): A216, 1993 [See Appendix A) ............. 13 OTHER HEALTH ISSUES [41] "Antenanl Smoking, Postnatal Passive Smoking, and the Sudden Infant Death Syndrome," J. Nicholl and A. O'Cathain. In: Effects of Smoking on the Fetus, Neonate and Child. D. Poswillo and E. Alberman (eds.). Oxford, Oxfard Unirxrsiry Prest, 138-149, 1992 [See Appendix A] ..................................................... 13 ETS EXPOSURE AND MONITORING (42] "Passive Smoke Exposure During Pregnancy: A Rodent Model," D.M. Schilling, M.R. Reed, R.M. Booze, and C.F. Mactutus, TcratoloV 47: 462, 1993 [SK Appendix A] ....13 INDOOR AIR QUALITY [43] "Indoor Air Quality and Environmental Tobacco Smok.r. Concentration and Exposure: ' L.C. Holcomb, Environment Internatiorral 19: 9-40, 1993 [See Appendix A] ....... 13 SMOKING POLICIES AND RELATED ISSUES [44] "Restrictions on Smoking: Changes in Knowledge, Attitudes and Predicted Behaviour in Metropolitan Toronto from 1983 to 1988;" L.L. Pedetxon, S.B. Bull, M.J. Ashley„and D. Kozrna, CanadianJourrtal ofPubGc Hsalth 83(6): 4a8-412, 1992 [See Appendix A] .....................................................................13

Contents Continued, Issue 50 ,JROPE & AROUND THE WORLD stEGULATORY AND LEGISLATIVE MATTERS AUSTRU [45] Agreement Reached by Government Officials on Tobacco Legislation ..................................14 EUROPFAN COMMUNITY (EC) [46] EC Commissioner Endotscs Workplace Smoking Ban ........................................................... 1 HONG KONG [47] Hong Kong Government Examines Indoor Air Quality ........................................................ 14 SINGAPORE [48] Health Warnings to Change ..................................................................................................14 OTHER DEVELOPMENTS AUsT1tAL1A [49] EGYPT [50) ITALY [51] Woodward Predicts Widespread Smoking Bans Within Five Years ........................................ 14 Physician Calls for Smoking Ban ...........................................................................................14 Oncology Institute Official Calls for More Research .............................................................. 14 SvvtrzEnl.+ND [52] Tobacco Industry Launches Press Campaign .........................................................................15 UNITFD KINGDOM [53) Health Education Authority Targets Workplace Smoking ..................................................... 15 [54] Smoking Ban Takes Effect in NHS Facilities .........................................................................15 MEDIA COVERAGE UNITED KINGDOM [55) "By Order: No Smoking In Furness," D. Kermode. North Western EveningMai4 May 20, 1993 ........................ ............................................................................................... ...............................15 APPENDIX A .................................................................................................... .................................Artide Summaries APPENDIX B .................................................................................................... ........................ComptainrAgainst EPA APPENDIX' C .................................................................................................... .................. The Washington Post Artide

JUNE 25, 1993 1 REPORT ON RECENT ETS AND IAQ DEVELOPMENTS IN THE UNITED STATES REGULATORY AND LEGISLATIVE MATTERS U.S. ENVIRONMEN?I'AL PROTECTION AGENCY (EPA) [1] Special Report: Suit Against EPA Seeks to Nullify ETS Risk Assessment A group of tobacco-related organizations sued the EPA on June 22, 1993, seeking a judgment requiring EPA to withdraw both its classification of ETS as a Group A carcinogen and the Risk Assessment on which that dassification was based. In four counts, plaintiffs' complaint charges EPA with (i) exceeding its statutory authority in conducting the risk assessment; (ii) using faulty science and improper scientific procedures to arrive at its conclusions; (iii) failing to follow its own risk-assessment guidelines; and (iv) violating the guarantee of due process of law in the Fifth Amend- ment to the U.S. Constitution. The six plaintiffs in the suit are the Flue-Cured Tobacco Cooperative Stabilization Corporation; The Council for Burley Tobacco, Inc.; the Universal Leaf Tobacco Company, Incorporated; Philip Morris Incorporated; R.J. Reynolds Tobacco Company; and Gallins Vending Company. The case was filed in the U.S. District Court for the Middle District of North Carolina. Flue-Cured Tobacco Cooperativr Sxabiliwtion Corporation, et aL, v. EPA, No. 6:93CV370 (U.S. District Court, Middle District, North Carolina) (filed June 22, 1993). Appendix B contains a copy of the plaintiffs' com- plaint, and Appendix C contains a copy of an article about the case from The Washington Post. On the subject of authority, plaintiffs' complaint alleges that EPA never had authority to classify ETS under its carcinogen-classification guidelines and that, in any event, EPA failed to follow the requirements of the Radon Gas and Indoor Air Quality Research Act, 42 U.S.C. g 7401, note. That is the statute on which EPA relied in conducting the risk assessment. When the risk asscssment was released on January 7, 1993, EPA Administrator William Reilly acknowl- edged that his agency did not have authority to regulate indoor air quality or environmental tobacco smoke. Nevertheless, Reilly made it clear that EPA intended that the risk assessment have a regulatory impact when he expressed the hope that "no further action by any government agency will be necessary to create a smoke-free office environment" other than the EPA classification of ETS as a Group A carcinogen. On the subject of science, plaintiffs allege that EPA's designation of ETS as a Group A carcinogen was arbitrary and capricious, principally because the classification is not supported by ETS epidemiology and is not justified by EPA's attempts to use main- stream smoke as a surrogate for ETS. "EPA was able to reach its condusion only by manipulating and 'cherry- picking' data, ignoring critical statistical studies and chemical analyses, failing to account for confounding factors and sources of bias, violating basic statistical principles designed to minimize the possibility that an apparent association is due to chance," and using scientific assumptions and methodologies not generally accepted by the scientific community or even the agency itself in other risk assessments it has conducted, the complaint alleges. "The single most egregious abuse was the EPA's steadfast refusal to incorporate the results of the two most recent studies of ETS into their risk assessment calculations. EPA and many others in the scientific community know exactly what those studies would do if incorporated: negate the EPA findings," said Steve Parrish, Senior Vice President and General Counsel for Philip Morris Inc. Parrish, along with representatives of the other plaintiffs in the case, announced the filing of the complaint on June 22, 1993. Responding to the plaintiffs' complaint, current EPA Administrator Carol Browner issued this statement:

2 "The agency's view is that secondhand tobacco smoke can cause cancer. This assessment is based on scientific evidence that has been thoroughly peer-reviewed and we stand by it." Browner became EPA's administrator after the risk assessment had been released. The judge assigned to the case via the court's assign- ment system is the Honorable William Lindsay Osteen, Sr., age 62. Judge Osteen was appointed to the bench in 1991 by President Bush. Before that, he practiced law in North Carolina for approximately 35 years. He was the United States Attorney for the Middle District of North Carolina from 1969 to 1974. For a summary of the contents and release of the ETS risk assessment, see issue 38 of this Report, January 7,1993. [2] EPA Fails to Replicate Anderson Carpet Study Results According to press reports, the EPA has been unable to replicate studies of carpet off-gassing which allegedly produced respiratory and neurologic symptoms and death in mice exposed to warmed carpet samples in the Anderson Laboratories. Although the agency did apparently produce similar effects in the Anderson Laboratories, tests conducted in its own labs could not reproduce the test findings. For a discussion of the Anderson Laboratories experiments, see issue 46 of this Report, Apri130, 1993. A researcher at the University of Pittsburgh, asked by the carpet and rug manufacturers' trade association to address the Anderson Laboratories' findings, has reportedly produced similar results using Anderson's research methods and equipment. Both he and the EPA have cautioned that additional research must be conducted. The House Government Operations Subcommittee on Environment, Energy and Natural Resources met on June 11, 1993, to consider testimony by Rosalind Anderson, representatives of the carpet industry, EPA and the Consumer Product Safety Commission (CPSC). Anderson's testing methods were challenged by the executive director of the Carpet and Rug Institute (CRI), who said a scientific advisory board studying the Anderson protocols found them to be "tantamount to lacing up a human being in a strait- jacket and repeatedly choking him for two days." The CRI announced that carpet manufacturers intend to ETS/IAQREPOR'I1, ISSUE 50 develop a new consumer information label for their products that would be aimed at chemically sensitive consumers. EPA and CPSC were reportedly criticized by subcom- mittee members for not acting quickly enough to address the issue. The agencies apparently defended themselves by noting how difficult it is under proce- dures mandated by Congress to set standards that can be successfully defended in court. According to a New York assistant attorney general, who also testified at the hearing, attorneys general from four states are considering initiating a law suit or filing a citizens' petition under the Toxic Substances Control Act to spur the EPA into regulatory action. They say there is concern that the current "green label" program developed by the industry is misleading to consumers in that carpets with chemicals at concentrations allegedly linked to illness are being sold with green labels attached. At the condusion of the hearing, EPA and CPSC reportedly agreed to (i) provide information about the chemical composition of carpets; (ii) hold a workshop to address conflicting scientific data; (iii) design a multi-million dollar indoor air research program to evaluate chemical toxicity and measure worker expo- sure to carpet chemicals; and (iv) develop "consumer information labels and posters" co notify sensitive individuals of potential chemical exposure from carpet emissions. See BNA National Environment Daily, June 15, 1993; Chicago Tribune, June 12, 1993; Grrrnurirr, The Hartford Courant, The Orlando Scntinrl; and PR Newswirr June 11, 1993; Associated Press and United Press Internationa4 June 10, 1993. > Mderson stiMycaAed'Junk Seience,: item 30. U.S. DEPARTmENT OF HEAI.rx AND HuMArr SERVicEs (HHS) [3] HHS Revises Draft Executive Order on Smoking According to a press report, HHS has revised a draft executive order which would ban smoking in most federal executive branch agencies. The proposal was originally developed during the Bush administration and induded a number of exemptions for those agencies strongly opposed to a ban, in an apparent effort to gain support during the

JUNE 25, 1993 final days of the Bush presidency. Those exemptions have reportedly been dropped, and HHS officials believe that the Clinton administration will be receptive to the proposal if it is framed as a measure to protect the health of federal workers and the public. The proposal will reportedly be presented to the Office of Management and Budget within the next several months. Antismoking advocates are evidently hoping that President Clinton will sign the order this year. A government-wide smoking ban is reportedly still opposed by such agencies as the Veterans Adminis- tration and the Central Intelligence Agency. See BNA Daily Labor Report, June 10, 1993. VETERANS ADMINISTRATION (VA) [4] Costs Estimated for VA Compliance with Smoking Standards According to a press report, the General Accounting Office has estimated that it will cost the VA $24 million to equip its facilities with separately-ventilated smoking areas or outside smoking shelters as mandated in 1992 by Congress. Only 44 VA medical facilities out of 159 apparently have smoking areas that meet the new law's standards. Officials at 132 of the facilities reportedly said that they would need more than one smoking area to accommodate their patients. Thus, some 998 smoking areas, at a cost of $40,000 to $225,000 each, would be required according to the GAO. See The Kansas City Star, June 13, 1993. 1 03D CONGRESS [5] Traficant Bill Approved by House Committee Following amendment, the "Ban on Smoking in Federal Buildings Act" (PRO-FEDS) (H.R. 881), introduced by Representative James Traficant (D- Ohio), was approved by the House Public Works and Transportation Committee. The bill now goes before the full House. PRO-FEDS, as originally drafted, would have prohibited smoking in all buildings owned or leased by the federal government. Traficant offered two amendments which would (i) permit the heads of federal agencies to designate certain areas of their buildings as smoking areas, if separately ventilated and (ii) exempt all Veterans Affairs health 3 care facilities and military installations. These amend- ments, and an amendment that would require the head of the General Services Administration (GSA) to report on new methods ofventilation two years after the law goes into effect, were approved and added to the measure. Legislators supporting the measure apparently cited the EPA Risk Assessment on ETS to argue that Congress has an obligation to protect the federal workforce. Opponents repon.edlyquestioned EPA's condusions and said the bill would discriminate against smokers. See Daily Report for Fxecutives, June 18, 1993. Representative James Clyburn (D-S.C.), stating that "a more thorough record" was required to make a decision on the bill, offered an amendment that would have required the submission of a report by the General Accounting Office on (i) the number of ETS- related workers' compensation claims; (ii) the liability the federal government may have for claims based on other airborne substances; (iii) the cost to government of employees leaving work for smoking breaks; and (iv)) the possibility of using other methods for reducing all levels of indoor air pollutants. This amendment was defeated by a vote of 8-3 during the bill's markup in subcommittee. According to a press report, a Traficant spokesperson is predicting that, in spite of the overwhelming major- iry of nonsmokers in Congress, there will be a"fight on the floor and a huge fight in the Senate - it may take a few years." Su States News Servict, June 16, 1993. [6] Capitol Architect To Announce Smoking Plan The Capitol Architect, who was charged by the House Office Building Commission with designing smoking accommodation areas on the House side of the Capitol, was expected to announce a plan in mid- June 1993. Ser issue 47 of this Report, May 14, 1993. According to an Architect spokesperson, the original plan would have permitted smoking in designated restrooms, but complaints about such a poliry have led the Ardiitect's office to consider designating smoking at the ends of office building hallways or in House garages. Smoking has been banned in all public areas of House buildings since May 7, pending approval of the Architect's plan. While smoking is permitted in individual offices at the discretion of House members and committee chairs, elsewhere smokers have appar-

4 ently been forced to smoke out of doors or on the Senate side of the Capitol where there are reportedly no plans to limit smoking. RoU Ca11 reportedly conducted a survey to determine how many members of Congress smoke and how many individual offices have adopted smoking bans or restrictions. At the present time, only 37 members of the House and six members of the Senate are smokers. Evidently, 76 members of Congress were smoking tobacco products four years ago. Although about one- fourth of all Americans smoke cigarettes, the number of Representatives and Senators who do so comprises less than four percent of Congress. According to the survey, 298 of the 535 Congressional offices completely ban smoking, up from 132 with such prohibitions in 1989. Many of the remaining offioes impose tough smoking restrictions. Only 26 offices, 21 in the House and five in the Senate, permit smoking without restriction. See RoU Ca14 June 14, 1993. [7) House Preparing Legislation to Improve Risk Assessments Bipartisan House staff are reportedly in the process of drafting legislation that would improve risk assessments by requiring regulatory agencies to disdose the assumptions they use and the techniques they employ in developing the assessments. According to Insidc EPAs unnamed sources, the measure is likely to be introduced later this year, and it parallels a requirement imposed last year upon EPA scientists by then-Deputy Administrator Henry Habicht to promote credible science. The draft language of this °Risk Communication Act" is apparently being circulated now within the House and among professional groups. Its purpose is to ensure that agency officials are alerted to the subjective assumptions about risks that are being made by staff who prepare regulatory options. A congressional source has reportedly said that the legislation differs significantly from a risk assessment measure that was added to the Senate bill that would devate the EPA to cabinet level status (S. 171). See issue 47 of this Report, May 14, 1993. Unlike the Senate bill, which would require federal agencies to conduct risk assessments, the House legislation would simply require federal agencies to release information about the ways in which risks are estimated ETSCIAQ REPORT, ISSUE 50 It is not known whether the bill will be introduced independently or whether it will be attached to the Cabinet bill or some other legislation. See Inside EPA, June 11, 1993. V'UHITE HOUSE [8] Administration Seeks Smoking Bans on Interna- tional Flights According to a press report, the Clinton administra- tion is negotiating with a number of governments to bring about a smoking ban on all international flights into and out of the United States. The negotiations are said to be necessary so that United States airlines are not put at an economic disadvantage. An agreement that is reportedly nearing completion involves the United States, Canada, Australia and New Zealand. Air Canada is the only carrier at present that bans smoking on all flights, domestic and international. See The New York Times, June 13, 1993. [9) Health Task Force Member Anticipates Federal Workplace Smoking Ban According to Michael Samuelson, a member of President Clinton's task force on health care reform, the EPA, acting through OSHA, will ban smoking in the workplace within two years. Samuelson apparently made his prediction during a seminar sponsored recently for Northeast Mississippi industry representa- tives by a local medical center and a national pharma- ceutical company. He reportedly advised seminar participants to ban smoking in the workplace in order to avoid lawsuits. SreAssocraud Preu, June 16, 1993. U.S. OCCUPATIONAL SAFETY AND HEALTH' ADMINISTRATION (OSHA) [10] Labor SecretaryAdvocates Speedier Rulemaking Labor Secretary Robert Reich, testifying before the House Education and Labor Committee on the pending OSHA reform legislation (H.R. 1280), was quoted as saying, "I do not believe that the agency should be required to perform detailed and time- consuming analyses of issues of which there is no reasonable basis for dispute, and which in fact are not actively disputed by parties to the rule-making."

JUNE 25, 1993 Reich's comments have led labor lawyers to conclude that the spirit of regulatory reform is alive again at the agency. Reich testified during a hearing conducted by the committee on April 28, 1993. See The National LawJournaZ June 7, 1993. Meanwhile, Pete Lunnie, industry's chief lobbyist on OSHA reform legislation, reportedly said on June 10 that he doubted the bill would become law in its present form during the 103d Congress. He says he believes the measure can be beaten in the Senate. According to Lunnie, the best approach to OSHA Reform would be to examine the current OSH Act, determine where the problems lie and then devise improvements. Lunnie, speaking before a group of industry safety offiaals, said he plans to meet with Reich on July 1 to outline the industry position on OSHA reform. See Daily Rrport fnrFxecutivrs, June 11, 1993. U.S. POSTAL SERVICE [11] Post Office Smoking Ban Challenged Following the Postal Service's smoking ban ordered to begin June 13, 1993, the American Postal Workers Union has reportedly lodged a grievance. The ban is also beingchallenged by the National Association of Letter Carriers and the National Postal Mail Handlers Union. An American Postal Workers Union spokesper- son stated, "It's just not fair to those who do smoke," and believed that there were less extreme ways to handle the situation. See The Boston Globe, June 15, 1993. The postal service ban was instituted as a result of the EPA Risk Assessment on ETS, according to the postmaster general. Sar issue 49 of this Report, June 11, 1993. U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC) [12] Joint Project Initiated to Study HVAC Systems and IAQ The CPSC and the National Institute of Standards and Technology have reportedly entered an interagency agreement which establishes a two-phase study of residential HVAC systems to determine their potential to reduce certain indoor air constituents. Computer modeling will apparently be used to we if existing HVAC technology can reduce selected con- 5 stituents to defined low levels. Constituents subject to the study will be nitrogen dioxide, carbon monoxide, particulates and biologicals. Sec Product Safety cir Liability Reporter, May 28, 1993: STATE AND LOCAL GOVERNMENTS [13] ETS-Related State and Local Legislation 'California According to news reports, the Senate recently voted 23-3 to adopt a resolution already passed by the Assembly that prohibits smoking in buildings owned, leased or occupied by the Legislature, induding the Capitol, floors of both houses, hearings rooms, offices, hallways, restaurants and bathrooms. See A.C.R 27, Regular Session (1993-94) and United Press Intmza- tiona4 June 11, 1993. According to a Price Waterhouse study sponsored by southern California hotel and restaurant associations, a state no-smoking law could jeopardize 82,000 jobs and cost California more than $3.5 billion. The study was a survey of hotel and restaurant managers about their estimates of what they would lose if smokers couldn't smoke in their establishments. Of 74 managers, 54 percent estimated a loss in business and 45 percent saw no change. One manager said business would improve. The study reported that a 100 percent smoking ban would cause an average loss of 7 percent in restaurant sales and an 18 percent loss in hotel and motel receipts, putting many people out of business. See Morning Newsbriefs, June 7, 1993. •Local Governments in California On June 23, 1993, by a vote of 8 to 6, the Los Angeles City Council approved a bill that would prohibit smoking in virtually all of the city's 7,000 restaurants, exduding dance dubs, bars, rented banquet rooms and outdoor eating areas. According to a spokesman for Mayor Tom Bradley, the chances of the bill's approval by the Mayor are good, but no final decision has been made whether he will sign or veto it before he retires from office next week. The Mayor could leave office without taking any action, in which case Mayor-elect Richard Riordan would have three days to act. Riordan allegedly supports a smoking ban in restaurants. The bill, even if it does become law, may be short-lived if the state Legislature passes a bill currently under

6 consideration in the Senate that would replace local smoking ordinances enacted after April 1 with a single standard (AB. 996). See The New York Times and USA Today, June 24, 1993. •Connecticut On June 7, 1993, the Senate reportedly approved 29-7 a bill that restricts smoking to designated areas in the State Capitol. The bill also prohibits smoking in all public 'elementary and high schools and in any place where the public conducts business. Governor Lowell P. Weicker, Jr. (ACP) has indicated he will sign the bill if there is "noth- ing untoward in it," reports a spokeswoman. The bill's author had introduced antismoking bills previously without success; however, the turning point reportedly came this year with the release of the EPA Risk Assess- ment on ETS and its claim that an alleged 3,000 non- smokers die each year from exposure to ETS. See The Hartford Courant, June 8, 1993, and May 25, 1993, and The New York Tima, June 6, 1993. •Louisiana Governor Edwin Edwards (D) has reportedly signed into law a bill that prevents municipal and parish governments from enacting legislation more restrictive than the state's on smoking in public buildings. The law requires state, parish and municipal governments to designate a smoking room or area in government buildings. Local antismoking laws enacted before September 1, 1993, will not be affected. Ste The AcsocYated Prru, June 9, 1993, and The Times Picayunr, June 16, 1993. •hocal Governments in Maryland The Howard County Executive vetoed a bill that would have prohibited smoking in most public places, including office common areas, child care centers, beauty shops and stores, according to news reports. Smoking in restaurants would have been eliminated by 1996. The county executive was reported to say that he sympathized with the intent of the bill, but a ban might put restaurants at an economic disadvantage with competitors in neighboring counties. He also allegedly objected to the bill's provisions exempting bars and making it illegal for employers to fire or refuse to hire a person who smokes outside the workplace. See The Washington Post, June 19, 1993, and The Washing- ton Times, June 20, 1993. In Anne Arundel County, the County Council enacted a smoking prohibition that will affect banks, classrooms, auditoriums, health care ficilities, public meeting rooms, ETS/IAQ REPORT, ISSUE 50 museums, libraries, restrooms, and other areas. See The Balt imore Sun, June 8, 1993. •Midugan The Michigan Department of Public Health, in a report released on June 2, has apparently found a high level of voluntary compliance with the state's Clean Indoor Air Act, which restricts smoking in public places and govern- ment workplaces. According to the report, the department has received more than 3,000 calls for information since the statute took effect in 1987. Formal complaints were evidently filed against facilities covered by the law in 163 cases, and of those complaints 93 percent were resolved. The Department has apparently recommended amend- ing the law to place restrictions or complete bans on smoking in additional locations, including private workplaces and restaurants. The report indicates that the most common problems under the current law involve smoking in nondesignated areas, designation of smoking in inappropriate areas, lack of adequate ventilation and failure to adequately consider those who are purportedly hypersensitive to ETS. See Toxic Chemicals Litigation Report, June 10, 1993. •New Hampshire Town councilors of Bedford, New Hampshire, have reportedly voted 5-2 to defy the state's Indoor Smoking Act which calls, among other matters, for segregated smoking areas in publicly owned buildings. Uhdu the Act, physical barriers must separate smokers from non- smokers, and designated smoking areas should be con- sttucted near exhaust vents. Persons in charge of public buildings who violate the Aa face fines of up to $100. Bedford officials reportedly said that they are "tired of government telling us what to do and legislating common sense and morality," and that they are making "a stxte- menr." They call the law an "unfunded mandate" which requires that a community spend money without the state providing the funds. See Bonon Gbby June 15, 1993. ETS-RELATED LITIGATION AGAINST CIGARETTE MANUFACTURERS [14] Blanchard Hearing on Venue Motions to be Held on July 1 The court will hear argument on defendants' motions to transfer venue and motions to strike on July 1, 1993.

JUNE 25,,1993 In broad terms, the motions contend that the current venue of Galveston County, Texas, is improper because (i) plaiintiffs' causes of action did not accrue there; (ii) that the claims asserted on behalf of the various plaintiffs did not arise out of the same transac- tions or occurrences; (iii) that plaintiAs did not seek leave of the court before filing their supplemental and amended petitions, that added new parties to the case; and (iv) that the petitions are improper attempts at forum-shopping. Three of the 14 plaintiffs in this case presently allege injury from exposure to ETS. Raye Blanchard and Tamara Reed, mother and daughter, both claim damages for unspecified "illness and disease" allegedly resulting from exposure to the ETS from cigarettes smoked by Raye's deceased husband, Thomas, and by Raye herself, who daims she smoked "for about ten years." The third ETS plaintiff, Pamela Kastrin Stephens, claims unspecified "lung and respiratory diseases" allegedly caused by exposure to the ETS from the cigarettes smoked by her deceased father. The named defendants are purported to be the six major U.S. cigarette manufacturers, The Tobacco Institute, the Council for Tobacco Research, and a number of wholesalers and retailers. Blanchard, etat, v. RJ. Rrynolds Tobacco Company, et at (District Court, Galveston County, Texas) (filed July 31, 1992). (15] Broin: Rehearing Petition Filed; Depositions of Executives Stayed On June 11, 1993, defendants: • Filed a motion for rehearing and for certification with the Third District Court of Appeal from that court's May 27 ruling denying defendants' petition for writ of certiorari; • Sought from the trial court and were denied a motion for protective order regarding depositions noticed of senior tobacco company executives that were to be taken from June 14-22; and • Sought from the Court of Appeal and received an emergency motion for a stay of the depositions of the company executives. The stay will remain in effect pending further order of the appellate court. Plaintiffs fil~ ed a motion to vacate the stay on June 14, but the Court of Appeal 7 denied it on June 18 before defendants submitted their response. In the trial court order that preceded the stay from the appeals court, Judge Robert Kaye had di- rected that the depositions go forward on June 14 despite the pendency of the motion for rehearing. At issue in this case are the claims of 28 flight atten- dants allcgedly injured by occupational exposure to ETS. In addition, the husband of one of the flight attendants claims loss of consortium. The attendants purport to represent a class of approximately 60,000 other attendants. Injuries alleged by the putative class representatives include lung cancer, breast cancer and unspecified respiratory ailments. Plaintiffs further allege that occupational exposure to ETS on board aircraft causes at least 22 diseases and a reasonable fear of contracting such diseases. The defendants are purported to be the six major U.S. cigarette manufacturers (plus related entities), UST, Inc., United States Tobacco Company, Dosal Tobacco Corp., the Council for Tobacco Research, The Tobacco Institute, and three trade associations. Broin, etaL, v. I'hilipMorris, etaf. (Circuit Court, Dade County, Florida) (filed October 31, 1991). [16] Butla: Trial Date Set for September 5, 1994 On June 8, 1993, Judge Gibbs entered a scheduling order setting a trial date of September 5, 1994. The scheduling order directs plaintiffs to designate their expert witnesses on September 24, 1993; for defen- dants to designate their experts on October 22, 1993; for all motions, except dispositive motions and evidentiary in limine motions, to be filed on December 31, 1993; for discovery to be completed by January 30, 1994; for all dispositivc motions to be filed by May 27, 1994; and for the final' pre-trial conference to be held on August 13, 1994. Plaintiffs contend that Burl Butler, a barber in Laurel, Mississippi, developed lung cancer as a result of his occupational exposure to environmental tobacco smoke. The defendants in this case consist of the six major U.S. cigarette manufacturers and several local retailers. Butlcr v. RJ. Rrynolds Tobacco Company, et a1 (Circuit Court, Hinds County, Mississippi) (filed Oaober 21, 1992).

8 [17] Dunn: Defendants Granted Extensions to Respond to the Complaint Plaintiffs' attorneys have extended the date for defendants to respond to the complaint. Responses are now due August 12, 1993. Plaintiffs in this case contend that Mildred Wiley was a nonsmoker who died of lung cancer as a result of her exposure to environmental tobacco smoke at her place of employment (a Veteran's Administration hospital) for seventeen years. Her husband, Philip Wiley, is also asserting a loss of consortium daim. Defendants in the case are purported to be each of the six major U.S. cigarette manufacturers, parent companies of three of the manufacturers, The Tobacco Institute, and the Council for Tobacco Research. Dunn, et at v. RJR Nabisco Holdings Corporation, ct aL (Superior Court, Delaware County, Indiana) (filed May 28, 1993). [18] Vorh: Motion to Dismiss Filed On June 14, 1993, Brown & Williamson filed a motion to dismiss the complaint based on plaintiffs failure to state a claim. On June 11, R.J. Reynolds and Forsyth Tobacco Products filed a joint answer to the complaint. Frank Voth, who is incarcerated in the Oregon State Penitentiary, alleges that his civil rights have been violated as a result of his exposure to ETS. He daims he has "incurred permanent health damage and is at risk of death" as a result of such exposure. Defendants in Uoth are Forsyth Tobacco Products, R.J. Reynolds and Brown & Williamson. Voth v. Forsyth Tobacco Products, et at (U.S. District Court, Oregon) (filed April 27, 1993). ETS/IAQ LITIGATION NOT INVOLVING CIGARETTE MANUFACTURERS PRISONER CASE [19] Special Report: HeUing v. McKrnne, 1993 WL 209628 (U.S. Supreme Court) (decided June 18, 1993) In a 7-2 opinion, the U.S. Supreme Court gave inmate William MclGnney an opportunity to try to prove that ETS/IAQ REPORT, ISSUE 50 Nevada prison authorities have violated the Eighth Amendment to the U.S. Constitution by exposing him to levels of ETS that pose an unreasonable risk to his future health, but the Court made it clear that his burden of proof will be extremely heavy. Further, the Court recog- nized the official position of the United States Govern- ment, as reflected in the amicus currae arguments of the Solicitor General, (i) "that the harm to any particular individual from exposure to ETS is speculative° and (ii) "that exposure to ETS is not contrary to current standards of deoenry." The Court expressed no opinion on whether ETS exposure in fact poses a risk of harm. In the end, the Court simply ruled that McKinney's lawsuit could not be summarily dismissed at a preliminary stage with no chance to prove his daim. "We cannot rule at this juncture that it will be impossible" for McKinney to make his claim, the Court said. On remand, McKinney must prove not onlythe objective and subjective elements necessary to find an Eighth Amendment violation, but he also must prove that he is entitled to the specific remedy of an injunction. In order to prevail, McKinney must show four things. First, that he is currently being exposed to "unreasonably high levels of ETS." Second, that the exposure subjects him to "unreasonable risk with respect to his future health." Third, that the risk he complains of is "so grave that it violates contemporary standards of decency to expose anyone unwillingly to such a risk" And fourth; that the prison authorities' current attitudes and conduct amount to deliberate indifference to the risk The Court said "the realities of prison administration" can be taken into account in determining whether prison officials are acting with deliberate indifl'erenoe toward McKinney. The Supreme Court emphasized that a forrnal smoking poliry is now in effect in the Nevada State Prisons and noted that the policy may make it impossible for McKinney to prove at least two of the required elements of his case: (1) that he is now being exposed to an unrea- sonable risk to his future health; and (2) that prison authorities are acting with deliberate indifference to the alleged health effects of ETS. "In this respect we note that at oral argument McKinney s counsel was of the view that depending on how the new policy was administered, it could be very difficult to demonstrate that prison authori- ties are ignoring the possible dangers posed by exposure to ETS," the Court said.

JUNE 25, 1993 Justice White delivered the Court's opinion, which was joined by Juscices Rehnquist, Blackmun, Stevens, O'Connor, Kennedy and Souter. Justice Thomas wrote a dissenting opinion, which was joined by Justice Scalia. Justice Thomas said he would dismiss McKinney's claims as a matter of law and would "reject the claim that exposure to the risk of injury can violate the Eighth Amendment." The Office of the Solicitor General submitted a brief and participated in oral argument in this case as amuur curiae supporting the Nevada prison officials. In characterizing the position taken by the U.S. Government in its argu- ments, Justice White used these words: "[T]he United States submits that the harm to any particular individual from exposure to ETS is speculative, that the risk is not sufficiently grave to implicate a`serious medical nee[d],' and that exposure to ETS is not contrary to current standards of decency." WORKPIACE: COLLECTIVE BARGAINING [20] In tbe matter of Tyndall Air Force Base, Florida and Loca13240, American Federal of Governme nr Employees, AFL-C7O,1993 WL 184118 (Federal Service Impasses Panel) (decided May 25, 1993) A federal arbitration panel has determined that an employer may impose a smoking ban at its Main Ex- change facilities as long as it offeis smoking cessation classes to its employees and designates an outdoor smok- ing area that is reasonably accessible to employees and provides a degree of protection from the dements. The matter came before the panel due to a negotiation impasse, and the panel decided to resolve the issue on the basis of written submissions from the parties. The union had asked for employee polling and designated indoor smoking areas. The panel approved a modified version of the employer's proposal on the basis of "the overwhelming scientific evidence concerning the adverse impact of exposure to second-hand smoke." The panel further asserted, "a ban on indoor smoking is neoessary to enhance the health of all individuals at the Main Exchange." 9 WORKPIhCE: LAQI SICK BUILDING SYNDROME [21] A'/eeklt,y v. Industrial Commission, 1993 III. App. LEXIS 866 (Second District Appeliate Court, Illinois, Industrial Commission Division) (decided June 9, 1993) The Appellate Court of Illinois has denied workers' compensation benefits to a woman who daimed that an office remodeling project caused her to suffer hypersensitivity to fumes and odors. After reviewing the evidence presented in the case, the court deter- mined that the claimant, an executive secretary, had failed to establish (i) any connection between her symptomatology and the materials used in the remod- ding project; (ii) any type of risk in her work environ- ment greater than that to which the general public is exposed; or (iii) that her condition resulted either from the remodeling project or the general office environ- ment. According to the court, medical records showed that many of the daimant's complaints predated her employment. The court also rejected the claimant's argument that the Industrial Commission improperly excluded from evidence publications about sick building syndrome. LEGAL ISSUES AND DEVELOPMENTS [22] Special Report: Washington Court Denies Reimbursement of Former Smoker's Alleged Quitting Expenses On June 22, 1993, a small claims court in Seattle denied a former smoker's daim for reimbursement of the expenses he allegedly incurred in quitting smoking. The court ruled that the statute of limitations for the case expired before the claim was filed. The plaintiff, Alfred J. Deskiewicz, Jr., filed the case in December 1992 against Philip Morris Incorporated. Deskiewicz claimed he began smoking Marlboro in 1959 at age 17 because he was enticed by Philip Morris' advertisements. He sought recovery of approxi- mately $1,153 to enable him to stop smoking due to his alleged addiction to Marlboro. He sought $343.50 to compensate him for the cost of doctor's visits to help him quit, $271.95 for the cost of nicotine patches,

10 $189.99 to reimburse him for the money he spent on cigarettes from the time he began trying to quit smoking until he finally stopped, and $349.00 for a fifteen-month health club membership, which he contended he needed after quitting. The case was tried to Judge Linda Jacke earlier this month. Judge Jacke held that the statute of limitations for Deskiewicz's daim had expired because he had known as early as the 1970s that he had a potential claim against Philip Morris. That was when he tried twice, unsuccessfully, to stop smoking. Losing parties in Washington small claims court cases who file a timely request are entitled to a new trial in the Circuit Court, Washington's court of general jurisdiction. [23] "Smoke Alarm," E Hopkins, Mirabella, July 1993 This article, written by an alleged asthmatic with an acknowledged antismoking bias, examines a number of ETS-related issues including workplace smoking policies, smoking disputes in child custody cases, and antismoking legislation. The author characterizes ETS as "extremely hazardous° and cites the EPA Risk Assessment on ETS to support her claims. According to this artide, divorce lawyers believe that the ETS risk assessment will "substantially influence the outcome of many future custody suits." Richard Daynard of the Tobacco Products Liability Project and John Banzhaf of ASH are quoted in the article which condudes that "the days of smoking rights are numbered ...[as] nonsmoking activists are getting mad and even." OTHER DEVELOPMENTS [24] Michigan Malls Rely Upon EPA Risk Assess- ment to Support Smoking Ban According to a press report, five shopping centers in Southwest Michigan have adopted a smoking ban in all public and common areas, effective September 1, 1993. A spokesperson for Shopping Centers of South- west Michigan reportedly cited the EPA Risk Assess- ment on ETS to support the ban. The new policy will apparently not affect the interior of individual stores and restaurants. See PR Newswire, June 15, 1993. ETS/IAQ REPORT, ISSUE 50 [25] Kansas City Area Joins Debate Over Smoking in Public Places A citizens advisory council has reportedly asked Overland Park, Kansas, officials to consider making the city the first in the metropolitan Kansas City area to ban smoking in all public places including restaurants and hotels. The matter will apparently be discussed during a public meeting on July 7. Tourism officials and the Missouri RestaurantAssocia- tion in Kansas City are already reportedly opposed to the idea, and a local restaurant which tried to adopt a smoking ban in April was forced to rescind the ban following a "vicious backlash" from smoking customers. According to hotel and restaurant members of Overland Park's Cham- ber of Commerce, local businesses already set aside space for nonsmokers based on market demand. See Kanun City Stnr, June 17, 1993. [26] Smoking Cessation Program Aims to Create Smoke-free Environment Lederle Laboratories is reportedly providing 250 adult smokers in Paterson, New Jersey, with its ProStep nicotine transdermal system free of charge as part of a program to eliminate purported smoking-related health hazards for smokers and their families. Counseling and behavioral modification will also be made available as part of the program. A professor of clinical psychiaay at a local medical university which is running the program cited the EPA Risk Assessment on ETS as "condusive evidence of the harmful effeccs of both active and passive cigarette smoking." See PR Nnrmwire, June 8, 1993. [27] World Bank Employees Vote to Ban Smoking According to a press report, the 6,000 employees at the World Bank's headquarters in Washington, D.C., have voted to ban smoking in the building. The vote has apparently caused consternation among some of the bank's directors who smoke. See The Guardian, June 9, 1993. [28] Los Angeles County High School Speech Contest Asks "Should Smoking be Banned in Public Places?" In response to the EPA Risk Assessment on ETS, the Los Angeles County Tobacco Control Program, in conjunction with the Los Angeles Unified School

JUNE 25, 1993 District sponsored a high school speech contest. The topic, "Should Smoking be Banned in Public Places?", was chosen to encourage students to learn more about public health issues. Most participants conduded that smoking should be banned in public places, citing the findings of the ETS risk assessment. See PR Newswire, June 7, 1993. [29] AMA Supports Legislation Banning Tobacco The American Medical Association (AMA), at its annual meeting, adopted a resolution to support legislation that would prohibit smoking in prisons and jails. The 435 delegates also approved measures supporting federal legislation for smoke-free schools and reaffirmed its opposition to tobacco sales from vending machines. Also formalized was a policy to reject revenue form tobacco companies, but not necessarily from the companies' non- tobacco subsidiaries. SeeAssociaud Prus, June 17, 1993. MEDIA COVERAGE [301 "Magic Carpets," T.W. Orme, Ph.D., Priorities, Winter 1993 This article discusses the attention that carpet emissions have been getting from the press and Congress, and dismisses the Anderson study as "junk science at its worst." The author, a representative of the American Council on Science and Health, observes that Anderson does not follow the government's Good Laboratory Practices Guidelines and has not published in peer reviewed journals. Dr. Orme expresses his concern that the Senate committee considering Anderson's testimony in October 1992, "preempted the role of scientists in scientific review [and] was unqualified to ask the appropri- ate questions." The article also disco.sscs the controversy surrounding claims of "multiple chemical sensitivity" and states, "A conscientious scientist reading the current literature on MCS comes away more oonfusod than enlightened by it. Is MCS a political movement, a religion or a disease?" Apparently, a woman from Vermont who claims that she and her family coneractad MCS from new carpeting has received treatment that has been suggested as a means of spiritual renewal but is not standard medical procedure. > EPA fais to duplikate Anderson's findings, item 2. 11' [31] "Times Just Says No to Tobacco Advertising - Evidence of Danger `Overwhelming,'" S. Wieland Nogaki and H. Gupta, The Seatxle Times, June 14, 1993 Citing recent evidence regarding the purported dangers of ETS exposure, as well u"growing medical evidence on the dangers of smoking," the publisher of The Seatnlc Times has reportedly decidedto cease accepting advertise- ments for tobacco products. The ban will take effect when existing contracts expire by the end of the year and will apparently result in lost revenues of at least $120,000 to $150,000. The Tobacco Institute (TI) reportedly eriu- dzod the decision as an attack on the FirstAmendment. According to a TI spokesperson who is quoted in the artide, "I'm astonished that a newspaper that I imagine would embrace the First Amendment would selectively deny space to an advertiser for a legal product just on the basis that a certain segment of the community disagrees with the message. It sets a disturbing trend." [32] "Health Agency Investigates Airplanes and TB Infections," M. Tolchin, The New York Times, June 21, 1993 This article discusses Federal health officials concerns that airplane passengers with tuberculosis may be infecting fellow passengers on long flights. Officials seek to determine whether the recirculation of air in planes would allow the transmission of tuberculosis, a bacterial disease that is spread through the air. Officials say data is still being collected and they declined to disclose any preliminary findings. SCIENTIFIC/TECHNICAL ITEMS LUNG CANCER [33] "Meta-aaalysis of Epidemiological Studies of Carcirtogeaesis," J. Peto. In: Mechanimu of Carcinogcnesi.r in Risk Ident#rcatron. H. Vainio, P.N. Magee, D.B. McGregor, and A.J. McMichael (eds.). Lyon, International Agency for Research on Cancer, 571-577, 1992 [See Appendiz A] This article discusses characteristics of epidemiologic studies with respect to the validity of meta-analysis in

12 assessing those studies. The author uses as an example the meta-analyses that have been conducted on the epidemiologic studies of spousal smoking and lung cancer. The author notes that "there are valid grounds for suspecting that the observed effects of passive smoking on lung cancer may be partly, or even entirely, due to bias." RESPIRATORY DISEASES AND CONDITIONS - CHILDREN [34] "Snoring, Sleep Disturbance, and Behaviour in 4- 5 Year Olds" N.J. Ali, D.J. Pitson, and J.R Stradling, Archives of Drseau in Childhood 68: 360-366, 1993 [See Appendix A] The authors of this paper studied children deemed to be at high risk for sleep and breathing disorders. They report that maternal but not paternal smoking was associated with the high risk group, and that those children were thought to be more hyperactive and inattentive by both their parents and their teachers. [35] "The Relationship of Nasal Disorders to Lower Respiratory Tract Symptoms and Illness in a Random Sample of Children," M.B. Barr, S.T. Weiss, M.R Segal, I.B. Tager, and F.E. Speizer, Pediatric 1'ulmonology 14: 91-94, 1992 [See ApPendnc A] This study examined maternal smoking with respect to children's nasal symptoms, and also studied the possible relationship between nasal disorders and c}u+onic lower respiratory symptoms. The authors report that frequent colds and sinus trouble were "highly associated with chronic lower respiratory symptoms." Statistically signifi- cant odds ratios for both colds and sinus trouble are reported for maternal smoking, which is also described as a "significant predictor" of lower respiratory symptoms. [36] "Increased Influence of Passive Smoking on Hospitalization for Respiratory Disease in Low Birthweight Infants," Y. Chen, S.L Home, and JA Dosman, American Review ofRespiratory Disease 147(4 Part 2): A213, 1993 [See Appendix A] This abstract reports on a comparison of the "risk and incidence" of hospitalization for respiratory disease ETS/IAQ REPORT, ISSUE 50 among infants of low and normal birthweight report- edly exposed to ETS in the home. The authors con- dude that low birthweight infants from households where there was smoking were more likely to be hospitalized for respiratory illness than were those of normal birthweight. [37] "Effects of Early Vs. Iate Environmental To- bacco Smoke Exposure on Pulmonary Function in Children," J. Cunningham, D.W. Dockery, and F.E. Speiur, American Review of Respirarory Diaeare 147(4 Pan 2): A213, 1993 [See Appen- dix A] Based on data from a cohort of 8,970 children in North America, the authors report that maternal smoking during pregnancy was significantly associated with measures of reduced lung function in children. They suggest that this exposure "may explain a signifi- cant part of the association of ETS exposure and reduced pulmonary function in later childhood." [38] "Parental Smoking and Respiratory Problems in Childhood," ].-A. Evans and J. Golding. In: Effects of Smoking on the Fetus, Neonate and Child D. Poswillo and E. Alberman (eds.). Oxford, Oxford University Press, 121-137, 1992 [Sec Appendix A] The authors of this chapter report on new analyses of data from the 1970 British Births Cohort. These analyses investigate maternal smoking during pregnancy and after the child's birth with respect to several respiratory end- points. The authors claim that maternal smoking during pregnancy is associated with wheezing, bronchitis and pneumonia in the child, and that maternal smoking during childhood is associated with snoring/mouth breathing, ear discharge and possibly chronic cough. [39] "Eight-months Incidence of Acute Respiratory Infections and Involuntary Smoking in Adoles- ~ cents," D.B. Teculescu, E. Rebstock, Q T. Pham, A.D. Corlan, and J: P. Deschamps, American Review of Respiratory Disease 147(4 endix A] Part 2): A134 1993 [See A O U' ~ , pp ~ French researchers report in this abstract on a study on the incidence of acute respiratory infections (e.g., bronchitis, common cold) in adolescents aged ten to 16. The authors report statistically significant elevated

JUNE 25, 1993 risks for acute respiratory infections when either one parent or both parents were smokers. RESPIRATORY DISEASES AND CONDITIONS - ADULTS [40] "Sidestream Tobacco Smoke (SS) Alters Re- gional Nasal Mucociliary Clearance: Compari- son of Sensitive and Nonsensitive Subjects," J. Nadarajah, R Bascom, T.K Fitzgerald, M. Bickert, K. Cheng, T. Permutt, and D. Swift, American Review of Respiratory Disease 147(4 Part 2): A216, 1993 [See Appendix A] In this experiment, "ETS-sensitive" and "nonsensitive" subjects were exposed to sidestream smoke followed by challenge with an aerosol. Nasal dearance was measured in both groups; 50 percent of the "sensitive" subjects reportedly exhibited an inhibi- tion of clearance after smoke exposure. OTHER HEALTH ISSUES [41] "Antenatal Smoking, Postnatal Passive Smok: ing, and the Sudden Infant Death Syndrome," J. Nicholl and A. O'Cathain. In: Effects of Smoking on the Fetus, Neonate and Cbild D. Poswillo and E. Alberman (eds.). Oxford, Oxford Univer- sity Press, 138-149, 1992 ['See Appendiz A] Using data collected in the United Kingdom, the authors of this study attempt "to uncavel the roles of maternal smoking during pregnancy and postnatal passive smoking in SIDS deaths." They report sratistically significant risk estimates for maternal smoking and for partner's smoking (a surrogate for ETS exposure). ETS EXPOSURE AND MONITORING [42] "Passive Smoke Exposure During Pregnanry: A Rodent Model," D.M. Schilling, M.R Reed, RM. Booze, and C.F. Mactutus, Teratology 47: 462, 1993 [See Appendix A] This abstract describes the experimental exposure of female rats to sidestream and mainstream smoke, 13 beginning before pregnancy and continuing until litters were born. The authors claim that the offspring of rats exposed to sidestream smoke as a surrogate for ETS exhibited decreased birthweight, slower growth, and pathologic changes in the brain. These endpoints were attributed by the authors to decreased oxygen levels during the prenatal period. INDOOR AIR QUALITY [43] "Indoor Air Quality and Environmental To- bacco Smoke: Concentration and Exposure," LC. Holcomb, Environment International 19: 9-40, 1993 [See Appendix A] Based on a review of literature on IAQ and ETS published since 1980, the author of this study suggests that "ETS has only a minor impact on IAQ ° More- over, he presents estimates of retained doses of ETS particles that range from 3 to 40 milligrams per year, a range which he suggests "does not seem to support" the summary relative risks calculated using meta-analysis. SMOKING POLICIES AND RELATED ISSUES [44] "Restrictions on Smoking: Changes in Knowl- edge, Attitudes and Predicted Behaviour in Metropolitan Toronto from 1983 to 1988," LL Pederson, S.B. Bull, M.J. Ashley, and D. Kozma, Canadian Journal of Public Hcalth 83(6): 408-412, 1992 [See Appendix A] Based on the results of two surveys, the authors of this artide claim that residents of Metropolitan Toronto showed marked changes in their attitudes about smoking. For instance, the authors report that between 1983 and 1988, Toronto residents began to more strongly favor restrictions on smoking (induding complete prohibitions). They also claim that, over the five-year span, residents became "no more knowledge- able about the health effects of smoking and ETS."

14 ETS/IAQ REPORT, ISSUE 50 SiNGAPORE IN EUROPE & AROUND THE WORLD REGULATORY AND LEGISLATIVE MATTERS AUSTRIA [45] Agreement Reached by Government Officials on Tobacco Legislation According to a press report, the health and finance ministers, the chancellor and the director-general of Austria Tabak have reached an agreement on amend- ments to proposed tobacco legislation. Provisions banning public smoking are reportedly unchanged, but no fines will be imposed for contravening the ban. Sct Die Tabak Zeitung, June 18, 1993. [48] Health Warnings to Change As of January 1, 1994, labels on cigarette packs will' reportedly be required to carry a warning in English stating that "Smoking harms your family." Evidently, the packages will no longer carry the phrase "Govern- ment Warning." According to a press report, this will be changed to "Health Warning." See The Smoking Regulations, May 29, 1993. OTHER DEVELOPMENTS AUSTRALLA [49] Woodward Predicts Widespread Smoking Bans Within Five Years EUROPEAN COMMUNITY (EC) [461 EC Commissioner Endorses Workplace Smok- ing Ban According to EC Commissioner Vasso Papandreou, the EC is considering "specific measures to limit or to ban smoking at the workplace." Papandreou's remarks reportedly were made in response to a written question to the commission. The workplace directive would apparently require, at a minimum, adequate ventilation and smoke-free restrooms for nonsmokers. See Safety Managemrnt, May 21, 1993. HONG KONG [47] Hong Kong Government Examines Indoor Air Quality The Hong Kong Government has brought in a team of specialists to dean office air ducts in its 1,208 government buildings. A contractor hired to do the deaning estimates that up to 20 percent of the 187,000 government workers may be suffering symptoms related to indoor air constituents. A government spokesperson denied that any of the buildings were suffering from sick building syndrome saying, "The deaning of air ducts is simply part of our scheduled work." See South China Morning Pott, June 13, 1993. Stephen Woodward, spokesperson for the New South Wales Cancer Council, has reportedly predicted that smoking will be banned in almost all indoor public places including bars and restaurants within the next five years. According to Woodward, smoking has already been banned in all commonwealth public service departments, in most hospitals and State health departments, and in businesses such as Telecom, Aust Post, Shell, ICI, CSIRO, BHP, AMP, Westpac, 3M, Price Waterhouse, and IBM. See Daily Tilegraph Mirror, June 15,1993. Woodward is also executive director of Australia Action on Smoking and Health (ASH). . EGY1rT [50] Physician Calls for Smoking Ban A physician has reporoedly called on his Arab colleagues to ban smoking in front of patients. According to Dr. Mohammed Basheer Shreim, more than half ofArab physicians smoke at work. SrrAl Hayas; June 4, 1993. ITALY [51] Oncology Institute Official Calls for More Research According to a press report, an official with the European Institute of Oncology in Milan claims that

JUNE 25, 1993 there is still a need to quantify the alleged risks of low- level exposure to ETS. He reportedly suggests, how- ever, that there is no need for new evidence to justify the adoption of measures to restrict smoking. Srt The Lancet; June 10, 1993. SWITZERLAND [52] Tobacco Industry Launches Press Campaign The Swiss tobacco industry has launched a press campaign calling for more tolerance and understanding between smokers and nonsmokers. The campaign apparently consists of a series of seven advertisements which will be run in 25 daily and weekly journals covering three linguistic regions of the country. The campaign's slogan is "Better to discuss than to fight." The first advertisement appeared on June 13, 1993, and will run for three weeks. UNITED KINGDOM [53] Health Education Authority Targets Workplace Smoking The Health Education Authority has recently pub- lished its strategy for the next five years. Among the Authority's goals is "to create a healthy working environment, including freedom from environmental tobacco smoke." Other targets include reducing purported risks associated with tobacco consumption. See Safety Management, May 1993. [54] Smoking Ban Takes Effect in NHS Facilities According to press reports, a ban on smoking in all NHS hospitals, offices and canteens, which will apparently affect one million employees, went into efffecc at the end of May. Evidently, smoking by long- term patients and patients in psychiatric wards may be permitted in limited areas. The director of.ASH has been quoted as saying that the rule may be flouted due to the decentralization of authority over individual trust hospitals. Health Minister Dr. Brian Mawhinney reportedly lauded the progress that had been made by NHS in adopting smoking policies "to protect patients, visitors and staff from the health risks of smoking." See Daily Telcgraph, May 31, 1993. 15 MEDIA COVERAGE UNITED KINGDOM [55] "By Order: No Smoking In Furness," D. Kermode, North Western EveningMaA May 20, 1993 This artide discusses the smoking bans and restric- tions that have been adopted by businesses and govern- ment entities in Furness. Barrow Town Hall has apparently restricted smoking to a temporary room, and workers at Tesco can only smoke in the restaurant. The British Gas terminal in Barrow will reportedly implement a total ban beginning in January 1994. Penalties for noncompliance, in some cases, include termination from employment. The author notes that some Furness firms have tried to accommodate smok- ers by creating smoking rooms.

JUNE 25, 1993 APPENDIX A The numbers assigned to the following article summaries correspond with the numbers assigned to the synopses of the articles in the text of this Report. LUNG CANCER [33] "Meta-analysis of Epidemiological Studies of Carcinogenesis," J. Peto. In. Mechaniom of Carcinoganesis in Risk Identifuation. H. Vainio, P.N. Magee, D.B. McGregor, and A.J. McMichael (eds.). Lyon, International Agency for Research on Cancer, 571-577, 1992 "A small relative risk based on data from a case-control study constitutes weaker evidence of a causal association than a similar risk observed in cohort studies." "Few epidemiological studies satisfy the stringent methodological criteria that should ideally be applied." "Meta-analysis of published studies presents consider- able, purely technical difficulties....Two related but distinct problems in assessing published data are publication bias and the distinction between hypothesis generation and hypothesis testing." "[M]eta-analysis in which the original data are formally re-analysed involves two further problems." "It is rarely possible to obtain the data for all relevant studies." "The exposure of interest will not usually have been categorized in ways that are directly comparable." "Until the 1980s, epidemiologists were concerned mainly with relative risks that exceeded about 1.5 and were often much higher. Many controversies now centre on much lower risks, a notable example being the effect of 'passive smoking' on lung cancer risk. The pooled data show a statistically significant effect, and all studies are consistent with a relative risk of about 1.3. In view of the many difficulties discussed above, however, it can plausibly be argued that such small effects are beyond the limits of reliable epidemiological inference (particularly for lung cancer, in which the major cause produces large relative risks), as smoking habits may be inaccurately recorded and are correlated with many other social and occupational factors, A-1 including the smoking habits of spouses. a number of spurious associations with relative risks for lung cancer of this order might thus be found in a large enough sample.... In the absence of a strong effect, a significant dose-response effect among exposed individuals may be a prerequisite for drawing the conclusion that epide- miological associations are probably causal. This is of course not a new idea but, until the advent of ineta- analysis, few such weak associations achieved statistical significance, and the issue was largely academic." "A related issue is the effect of adjustment for poten- tial confounders. A weak association which is due entirely to a correlation between the variable of interest and other variables which are inaccurately recorded will be reduced but not eliminated when the other variables are formally adjusted for. A reduction in risk following adjustment provides a useful indication of such a spurious association." "The difficulties in defining acceptable studies, and the way in which their selection can substantially alter the conclusion of a meta-analysis, is illustrated by the example of passive smoking and lung cancer. As noted above, the US National Research Council pooled all available studies and derived an overall relative risk of 1.34 (95% confidence interval, 1.18-1.53). A subse- quent meta-analysis (Fleiss & Gross, 1991) included only the nine studies that were conducted in the USA and derived a pooled relative risk of 1.12 (95% confi- dence interval, 0.95-1.30). These authors justified their restriction to US studies on three grounds: (i) only the population to which policy decisions will apply should be studied; (ii) types of cigarette and consumption differ from those in other countries and their effects may therefore not be relevant to the US life-style; and (iii) genetic and other life style difference [sic] between the USA and other countries may also invalidate foreign studies as a basis for predicting risks to Ameri- cans. As the prime purpose of this meta-analysis was to decide whether or not passive smoking causes lung cancer, all three reasons for excluding non-US studies are illogical unless it is believed that there may well be an effect in other countries but not in the USA. In this instance, the effect of the exclusion of other studies was evidently known in advance, and it is difficult to believe that the authors reached this decision on purely objective grounds. As noted above, there are valid grounds for suspecting that the observed effects of

A-2 passive smoking on lung cancer may be partly, or even entirely, due to bias; but to eliminate the observed effect by such post-hoc selection is scientifically dubious." RESPIRATORY DISEASES AND CONDITIONS -CHILDREN [34] "Snoring, Sleep Disturbance, and Behaviour in 4-5 Year Olds" N.J. Ali, D.J. Pitson, and J.R Stradling, Archives of Diseast in Childbood 68: 360-366, 1993 "Parents of 996 children aged 4-5 years identified consecutively from the Oxford health visitor register were asked to complete a questionnaire about breathing disorders during sleep. A total of 782 (78.5%) was returned. Ninety five (12.1%) children were reported to snore on most nights. Habitual snoring was signifi- candy associated with daytime sleepiness, restless sleep, and hyperactivity." "The questionnaire responses were used to select two subgroups, one at high risk of a sleep and breathing disorder and a control group. These children (132 in total) were monitored at home with overnight video recording and oximetry, and had formal behavioural assessment using the Conners scale." "Seven (7/66) children from the high risk group and none from the control group had obvious sleep distur- bance consequent on snoring an upper airway obstruc- tion. Thus our estimate of the prevalence of sleep and breathing disorders in this age group is 7/996 or 0.7%." "The high risk group had significantly higher nocturnal movement, oxygen saturation dip rates, and overnight pulse rates than the controls. Maternal but not paternal smoking was associated with the high risk group. Parents and teachers thought those in the high risk group were more hyperactive and inattentive than the controls, but only their parents thought them more aggressive." "Significant sleep and breathing disorders occur in about 0.7% of 4-5 year olds. Children whose parents report snoring and sleep disturbance have objective evidence of sleep disruption and show more behaviour problems than controls." "Children in the high risk group were significantly more likely to have a mother who smoked. This was indepen- ETStIAQ REPORT, ISSUE 50 dent of the effect of social cJass....The increased risk associated with paternal smoking was not significant." [35] "The Relationship of Nasal Disorders to Lower Respiratory Tract Symptoms and Illness in a Random Sample of Children," M.B. Barr, S.T. Weiss, M.R Segal, I.B. Tager, and F:E. Speizer, Pediatric Pulmonology 14: 91-94, 1992 "The goal of this study was to examine the relation- ship of maternal smoking to nasal symptoms and to determine if nasal disorders had an association with chronic lower respiratory symptoms, independent of maternal smoking." "Frequent colds were significantly associated with maternal smoking (OR), 3.00; 95% CI, 1.97, 4.58), and so was sinus trouble (OR, 4.73; 95% CI, 1.78, 12.51)." "We examined the relationship of frequent colds and sinus trouble to the occurrence of lower respiratory tract symptoms. Both indices of nasal disease were highly associated with chronic lower respiratory symptoms independent of other variables, such as age, sex, and maternal smoking." "The central findings of these analyses were a twofold increase in the odds of lower respiratory symptoms with frequent colds and a fourfold increase in the odds of lower respiratory symptoms with sinus trouble. These odds were independent of the observed eEFects of maternal smoking and other variables such as age and sex. Although maternal smoking was linked to frequent colds, control for maternal smoking did not diminish the association of frequent colds with lower respiratory symptoms. Sinusitis was less in8uenced by maternal smoking and more strongly associated with lower respira- tory symptoms, although the small numbers of subjects provided a less stable measure of the effect of this upper respiratory illness on lowu respiratory symptoms." "Maternal smoking was-indcpendently of colds or sinus troubles-a significant predictor of lower respira- tory symptoms. This finding is in agreement with results reported by others." "Our analysis demonstrates an association of upper respiratory illness with lower respiratory symptoms....[A]ssociated colds and lower respiratory

JUNE 25, 1993 symptoms may be dual manifestations of a single common factor: Alternatively, factors such as postnasal drip, nasal obstruction, inadequate lower airway protection, deficient conditioning of inspired air, or reflex changes are all possible casual mechanisms by which nasal disorders could influence lower respiratory events. Further investigation will be necessary to distinguish among these various possibilities." [361 "Increased Influence of Passive Smoking on Hospitalization for Respiratory Disease in Low Birthweight Infants," Y. Chen, S.L. Home, and ].A. Dosman, American Review ofRespiratory Disease 147(4 Part 2): A213, 1993 "It has been well documented that exposure to environmental tobacco smoke (ETS) increases inci- dence of respiratory illness and symptoms in young children. Whether low birthweight (LBW) modifies the effect of ETS has not been known.° "This analysis was performed on the combined data from the Jing-An and Chang-Ning epidemiological studies of children's health in Shanghai. All together, the data of 3285 infants from these two studies were used in this analysis. Infants were classified into 3 ETS groups according to the total number of cigarettes smoked daily by household members: none, light (1- 19 cfgarettes/day) and heavy (20+ cigarettes/day), and 2 birthweight groups: LBW (less than 2500 g) and normal (NBW, 2500 g or above)." "Both risk and incidence density of hospitalization for respiratory disease during children's first 18 months of life increased with increasing smoking consumption by family members among the LBW infants more rapidly than among the NBW infants. Compared to the NBW infants who were living in nonsmoking families, the odds ratio for first episode of hospitalization for respiratory disease was 1.40 in the NBW infants who were living in light smoking families and 1.61 in those who were living in heavy smoking families. In the LBW infants the odds ratio was 2.91 and 4.48 respec- tively, after adjustment for study area, sex and feeding by simple logistic regression analysis." "The influence of passive smoking on hospitalization for respiratory disease is greater in LBW infants than in those with normal birthweight." A-3 [37] "Effects of Early Vs. Late Environmental To- bacco Smoke Exposure on Pulmonary Function in Children," J. Cunningham, D.W. Dockery, and F:E. Speiur, American Review ofRespiratory Disease 147(4 Part 2): A213, 1993 "Recent studies have found that passive smoke exposure in utrm is associated with lower measures of flow in newborns, while earlier studies suggested an association between current maternal smoking and reduced pulmonary function in older children. The relative contributions of perinatal vs. late childhood ETS exposure in children were assessed in a cohort of 8,970 white children aged 8-12 from 22 North American communities. Maternal smoking history was supplied by the child's mother.... [R]eported maternal smoking during pregnancy was associated with lower FEVI, FEF2 y750* and FEF2S35%. No significant differ- ence was found in FVC. Current maternal smoking was also associated with lower FEV, , FEF2,.7s%and FEF2sjs% but not FVC.... [M]aternal smoking during pregnancy remained a highly significant predictor of lower lung function.... [T]he effects of perinatal passivc smoke exposure on lung function persist through childhood, and may explain a significant part of the association of ETS exposure and reduced pulmonary function in later childhood." [38] "Parental Smoking and Respiratory Problems in Childhood," J. A. Evans and J. Golding. In: Effects of Smoking on the Fetus, Neonate and Child D. Poswillo and E. Alberman (eds.). Oxford, Oxford University Press, 121-137, 1992 "There have been many studies on the possible respiratory effects of exposure to tobacco smoke during childhood. There is a lack of consistency in ages, condition, type of population, and statistical methods used. Nevertheless, the vast majority of studies do find some effects of smoking." "In many of the above studies there has often been a tendency to over-control. For example, to look at mater- nal smoking and control for birth weight and gestation, or examine childhood wheezing and control for parental respiratory disease is over-controlling and artificially diminishing any association that may be present." "Mhe balance of results indicate that it is maternal smoking that is associated with childhood respiratory disorder, none of the studies quoted has information

A-4 on both antenatal and postnatal exposure. There is currently only one data set with the infomnation necessary for rhis analysis: the 1970 British Births Cohorc." "This chapter reports the results of new analyses of these data using a different methodology." "The results indicate that the effects of passive smoking during the child's life are far less marked for lower respiratory conditions than they are for upper respiratory conditions." "For wheezing, there was no relationship with postnatal smoking but there was with prenatal smok- ing, implying that this is the key factor." "A history of bronchitis and of pneumonia, was very strongly related to maternal smoking during preg- nancy, but these mothers also smoke later during the child's life. Nevertheless, the fact that the postnatal smoking effeccs are much reduced for bronchitis and non-existent for pneumonia indicates that the key factor is maternal smoking during pregnancy." "This chapter has shown that, as previously reported, there is a strong relationship between maternal smok- ing and respiratory problems in the child. The bulk of the evidence from the prospective data shows that it is maternal smoking during pregnancy that makes the child particularly vulnerable to subsequent wheezing, bronchitis and pneumonia, but that it is postnatal smoking that makes the child vulnerable to habitual snoring/mouth breathing, ear discharge, and possibly chronic cough." [39] "Eight-months Incidence of Acute Respiratory Infections and Involuntary Smoking in Adoles- cents," D.B. Teculescu, E. Rebstock, Q.T. Pham, A.D. Corlan, and J.-P. Deschamps, American Review ofRespiratory Disease 147(4 Part 2): A134, 1993 "Involuntary or passive exposure to tobacco smoke is known to alter foetal lung development, to increase frequenry and severity of early respiratory infections in infants, to increase the prevalence of respiratory symptoms and alter development of lung function in young children. Does it also influence the susceptibility to acute respiratory infections (ARI) in teenagers? To answer this question we analysed the results of a community-based epidemiological study on a sample ETSIiAQ REPORT, ISSUE 50 of subjects aged 10 to 16 years ... Fifty-nine subjects had symptoms or signs ofARI at the moment of the study, and the parents of 82 others gave a positive answer to the question `Did your child have a bronchi- tis or common cold during the last 8 weeks?'; the sum represents a 30.6% incidence for the 8 months dura- tion of the survey. The incidence was the same in boys and girls. The incidence increased with parental smoking, being of 27.8, 30.3 and 46.8% for children with zero, one and respectively two parent smokers. Confounders (factors associated with both the exposure and the outcome) were a personal history of otitis, parent education level, use of aerosols at home and number of siblings. After adjustments for confounding factors, the association between ARI incidence and parental smoking remained significant: odds ratios and 95% confidence intervals were 2.03 (1.37-3.02) for one parent smoker, 4.14 (2.79-6.15) for two parent smokers. We conclude that passive exposure to parental tobacco smoke significantly increases susceptibility to respiratory infecrions, even in adolescents." RESPIRATORY DISEASES AND CONDITIONS ADULTS [40] "Sidestream Tobacco Smoke (SS) Alters Re- gional Nasal Mucociliary Clearance: Compari- son of Sensitive and Nonsensitive Subjects," J. Nadarajah, R. Bascom, T.K. Fitzgerald, M. Bickert, K Cheng, T. Permutt, and D. Swift, American Review of Respirasory Disease 147(4 Part 2): A216, 1993 "Our previous studies have characterized differential sensitivity to environmental tobacco smoke (ETS) among normal subjects. In this study, we hypothesized that ETS-sensitive subjects (ETS-S) would demonstrate altered mucociliary dearance compared with nonsensitive subjects (ETS-NS) following smoke exposure. Twelve healthy non-smoking subjects were challenged for one hour at rest on two days separated by at least one week to dean air or SS. Fifty minutes post-exposure, an aerosol...was administered to the nose. Regional dearance was measured forth minutes after aerosol administration." "Three ETS-S subjects demonstrated a marked inhibition of mucociliary dearance after smoke expo- sure. These data indicate that tobacco smoke enhances

JUNE 25, 1993 mucociliary clearance in ETS-NS subjects, but not ETS-S subjects." OTHER HEALTH IssuEs [41] "Antenatal Smolang, Postnatat Passive Smoking, and the Sudden Infant Death Syndrome,°' J. Nicholl and A. O'Cathain. In: E,,rcts of Smoking on the Fctuc, Neonate and Child D. Poswillo and E. Alberman (eds.). Oxford, Oxford University Press,138-149,1992 "[A] n attempt is made to unravel the roles of mater- nal smoking during pregnancy and postnatal passive smoking in SIDS deaths, using data from the UK multicentre study to make the evidence of an associa- tion more specific and to examine the causal hypothesis in the light of this evidence." "The resulting estimate of the independent risk of maternal smoking was 2.13 (95 per cent Cl 1.45, 3.13), and of the independent risk associated with the partner's smoking was 1.63 (95 percent CI 1.11, 2.40)." "As maternal smoking during pregnancy will usually be followed by postnatal smoking, the risk of SIDS associated with maternal antenatal smoking as usually estimated actually represents the risk associated with either antenatal smoking or postnatal smoking or both. On the other hand, smoking by the mother's partner is only likely to increase the risk of SIDS as a result of the consequent postnatal passive smoking of the infant. Consequently, the finding we have presented here-that there is a significant and independent increase in the risk of SIDS associated with the partner's smoking--strongly suggests that postnatal passive smoking does play a role in the risk of SIDS." "The finding that the risk of SIDS is related to passive postnatal smoking raises the question of whether any pan of the frequently identified risk associated with the maternal smoking during pregnancy is due to antenatal maternal smoking, or whether this risk is entirely due to the postnatal smoking that almost invariably follows antenatal smoking." "With regard to the risk associated with postnatal passive smoking, it is well known both that postnatal passive smoking leads to more infant and childhood morbidity, especially form lower respiratory tract illness, and that SIDS cases commonly have clinical and pathological evidence of respiratory disease. Unfortunately, it is not A-5 dear whether there is any connection between these terminal diseases and the subsequent infant deaths. It may be the case that smoking causes respiratory infections unrelated to the occurrence of SIDS, but also has some other unknown effect, which does contribute to the occurrence of SIDS." ETS EXPOSURE AND MONITORING [42] "Passive Smoke Exposure During Pregnanry: A Rodent Model," D.M. Schilling, M.R Reed, R.M. Booze, and C.F. Mactutus, Teratology 47: 462, 1993 "Only recently has it been appreciated that involuntary passive cigarette smoke exposure of the pregnant woman may have adverse effects on fetal health and devdopment. Accordingly, we initiated a series of studies to assess the effects of involuntary maternal passive smoking on offspring deveiopment. Using nose-only exposure young adult female rats received sham-exposure or exposure to sidestream smoke (SS, passive smoke) for 3 weeks prior to mating and throughout gestation: Untreated controls as well as mainstream smoke exposure controls (MS, active smoke) were also induded....Neither exposure affected litter size. Reductions in birthweight of 6-7% were noted with SS exposure (1 or 2 cig/day); MS exposure produced a graded reduction. Graded reductions of preweaning growth were also found. Pup brain weight was signifi- cantly reduced by prenatal SS or MS ocposure; the MS but not SS exposure effect was attributable to persisting body weight deficits. Brain morphometric analyses indicated SS exposure of 1 cig/day selectively decreased hippocampal cell fields whereas 2 cig/day affected the hippocampus as well as the corpus callosum, a more general brain development index. In sum, involuntary SS exposure during pregnancy produced minimal evidence of maternal toxicity, minor birthweight deficits, decreased prcwcaning growth, and selective brain pathology consis- tent with prenatal hypoxic conditions." INDOOR AIR QUALITY [43] "Indoor Air Quality and Environmental To- bacco Smoke: Concentration and E:posure," LC. Holcomb, Environment Internationa119: 9-40, 1993 "This study assesses the literature on indoor air quality and ETS published since 1980. Using the data

A-6 collected, it also attempts to determine what levels of substances measured indoors may result from the presence of ETS and calculates some of the doses which may be expected from exposure to ETS." "The literature search was restricted to work which took place in the U! S. and Canada and was published after 1980. There is important IAQ data being generated in European and other countries. However, potential differences in building age, ventilation types, room sizes and other factors may prevent data from other countries from being comparable to the U.S./Canadian data" "The following indoor air components were chosen for evaluation: respirable particulates (RSP); carbon monoxide; nicotine; nitrogen dioxide; formaldehyde; benzene; polycyclic aromatic hydrocarbons (PAH); and nitrosaminu. " "Based on current literature, it appears that ETS has an effect on the levels of nicotine and respirable particles in an indoor environment. There also is a slight increase in NOx levels in the presence of ETS. ETS appears to have less effect on the levels of carbon monoxide, formaldehyde, or benzene." "One can calculate the dose of RSP retained from ETS. This ranges from approximately 3 mg/y for a female exposed only at work to approximately 40 mg/y for a male exposed in all facets of his life. Occupational exposure is only a minor portion of total exposure in most cases. Exposures in one's private life may produce the largest retained dose of ETS particulates." "Attempts to calculate increased risk or excess mortal- ity from lung cancer and heart disease reportedly resulting from ETS exposure are not uncommon. These calculations, however, rely almost exclusively on epidemiologic studies that have no adequate measure of exposure or dose. Such studies are known to be subject to problems of bias and confounding factors which have not been taken adequately into account." "One of the paradigms of toxicology is that the magnitude of the does determines the response. Comparing the dose one may receive from ETS to the magnitude of daimed health effects provides one measure of the accuracy of those claims." "Other studies that have calculated ETS dosage have reported values similar to those calculated here. They also have found wide discrepancies between the level of ETS/IAQ REPORT, ISSUE 50 risk calculated by the epidemiology studies and that which can be supported by dosimetric calculations." "Until the problems of confounding and bias in the epidemiology studies are resolved, dosimetric consider- ations can be the only independent confirmation of the accuracy of their claims. At this point, it can only be concluded that the estimated dose of ETS one can be expected to receive does not support the health risk claims being made by USEPA (1990) and others." SMOKING POLICIES AND RELATED ISSUES [44] "Restrictions on Smoking: Changes in Knowl- edge, Attitudes and Predicted Behaviour in Metropolitan Toronto from 1983 to 1988," L.L. Pederson, S.B. Bull, M.J. Ashley, and D. Kozma, Canadian Journal of Public Health 83(6): 408-412, 1992 "While population-based changes in knowledge of the health effects of smoking and of environmental tobacco smoke (ETS), and in attitudes toward restrictions on smoking have been investigated to some extent in the United States, only limited data, collected by the tobacco industry, have been published for Canada. Further, the surveys that are reported have not always used the same questions or targeted the same populations, not have they covered a comprehensive range of items concerning smoking, smokers, ETS, and restrictive policies. We report information on changes in such knowledge, attitudes and behaviour in Metropolitan Toronto between 1983 and 1988. This information comes form two population-based surveys in which identical items and similar data collection procedures were used." "Knowledge of the health effects of active smoking and ETS did not change between 1983 and 1988. The distributions of smoking by associates revealed that fewer associates were perceived to be smoking in 1988. This was not reflected in the reports of actual smoking status. In addition, in 1988 more individuals reported being always bothered by smoke." "Between 1983 and 1988, marked changes occurred in the attitudes of the population of Metropolitan Toronto to restrictions on smoking. In 1988, the population consistently favoured more restrictions on smoking, induding its complete prohibition, in all settings examined. Further, there was greater support for the prohibition of sales in specific locations, the

JUNE 25, 1993 prohibition of advertising, differential insurance rates favouring nonsmokers, and higher taxes on cigarettes. These results reveal considerably stronger support for legislated measures than those reported by the tobacco industry. In 1988, more respondents reported being bothered by others' smoking than did their 1983 counterparts, possibly reflecting less tolerance with ETS. In contrast, no statistically significant changes were found in reported knowledge of the health effects of either active smoking or ETS. Self-reported smoking habits did not change, although fewer 1988 respon- dents reported smoking among their associates. The levels of current smoking obtained were similar to those for the entire population and below those reported by the tobacco industry." "The 1988 respondents were no more knowledgeable about the health effects of smoking and ETS than were respondents in 1983. The steady growth of informa- tion on the adverse effects of smoking and particularly, the rapid growth during the 1980s of knowledge concerning the adverse effect of ETS was not reflected in an increase in health knowledge scores of the 1988 respondents. While this is discouraging, given the health education efforts regarding smoking and ETS that were ongoing, it did not appear to impede marked attitude change."

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF NORTH CAROLINA GREE ~+188o+RO DIVISION W/rdSTGN-SfT 4EM FLUE-CURED TOBACCO COOPERATIVE ) STABILIZATION CORPORATION ) 1304 Annapolis Drive ) Raleigh, North Carolina 27608 j ) and j ) THE COUNCIL FOR BIJRSEY TOBACCO, ) INC. ) 3070 Harrodsburg Road ) Lexington, Kentucky 40503 ) ) and ) ) UNIVERSAL LEAF TOBACCO COMPANY, ) INCORPORATED ) 1501 North Hamilton Street ) Richmond, Virginia 23230 ) ) and ) ) PHILIP MORRIS INCORPORATED ) 120 Park Avenue ) New York, New York 10017 ) ) and ) ~ R.J. REYNflLDS TOBACCO ZOIIPANY ) 401 ?;ain Street ) Winston-Salem North Carolina ) 27102 ) Civil Action No. s,` ''-31' l 3`'~ and ) ) GALLINS VENDING COMPANY ) 715 Stadium Drive ) Winston-Salem, North Carolina ) 27101 Plaintiffs, ) ) ) ) vs . ) UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 401 M Street, S.W. ) Washington, D.C. 20460 ) ~ ) m O Ct; Gb ISSUE 50 %IT 00 APPENDIX B

and ) ) CAROL $RaWNER ) Administrator, Environmental ) Protection Agency ) 401 M Street, S.W. ) Washington, D.C. 20460, ) ) Defendants. ) 2OKPLAINT TOR DECLARATCRY AND INJDNCT RLLIZF Plaintiffs, for their Complaint, allege as follows: NATIIRE OF THE ACTION 1. This is an action against defendant Environmental Protection Agency ("EPA" or "Agency") and defendant Administrator Carol Browner seeking review of EPA's January 7, 1993, decision to classify environmental tobacco smoke ("ETS") as a"Gre+•" A" ("known human") carcinogen and the risk assessment on which that classification is based. EPA's actions violate the Radon Gas and Indoor Air Quality Research Act of 1986 ("Radon Act"), 42 U.S.C. ; 7401, note, the Adninistrative Procedure Act ("APA"), 5 U.S.C. J§ 701 et seq., and the guarantee of due process of law in the United States Constitution, U.S. Const. amend. V. Plaintiffs seek a declaration that EPA's classification of ETS as a Group A carcinogen and the underlying risk assessment are arbitrary, capricious, violative of the procedures required by law, and unconstitutional. As further relief, plaintiffs seek a permanent injnnct.ion xequiring EPA to withdraw its decision of January 7, 1993, ard the accompanying risk assessment. 2

2. EPA's risk assessment of ETS, entitled "Respiratory Health 'Effects of Passive Smoking: Lung Cancer and Other Disorders" ("ETS Risk Assessment"), formally designates ETS as a Group A carcinogen, the highest carcinogenic designation under EPA's scheme for classifying suspect carcinogens. The classification of ETS as a Group A carcinogen was intended to and in fact did have a substantial impact throughout the country, including but not limited to compelling increased restrictions on smoking by private entities and all levels of government. EPA's actions with regard to ETS violated express statutory restrictions on its authority in the Radon Act and violated statutory commands to convene and consult with specific advisory committees. 3. EPA's classification of ETS as a Group A carcinogen is wrong as a matter of law and science and, as such, is arbitrary and capricious. As demonstrated in this Complaint EPA was able to reach its conclusion only by manipulating and "cherry-picking" data, ignoring critical statistical studies and chemical analyses, failing to account for confounding factors and sources of bias, violating basic statistical principles designed to minimize the possibility that an apparent association is due to chance, and generally altering EPA's models, assumptions, and methodologies when use of the Agency's usual models, assumptions, and methodologies wculd not have supported its conclusions. The classification of ETS ard the underlying risk assessment violated 3

EPA's own guidelines on how risk assessments should be performed, were the product of agency bias and violated plaintiffs' rights to due process of law. 4. The failure of EPA to base its classification of ETS on sound scientific principles and methodologies is exactly the type of agency action that an Expert Panel convened by former EPA Administrator Reilly recently criticized. That Panel found that too often EPA science "lacks credible quality assurance, quality control, or peer review," and "does not give sufficient attention to validating the models, scientific assumptions, and databases it uses." It also concluded that "(t]he interpretation and use of science is uneven and hrZhazard across programs and issues at EPA." More critically, the Panel found that EPA improperly ignores science entirely in its early decision making and is perceived as "adjusting" science to fit its predetermined policy. gafeauardinq the Futures Credible Science. Credible Decisions. The Re2ort of the Exflert Panel on the Role of Science at EPA (March 1992). Nowhere are these criticisms more justified than in the Agency's actions regarding ETS. OUTLINE OF COKPLAINT gaae 1 . THE PARTIES . . . . . . . . . .. . . . . . . . .. . 6 2. JTJRISDICTION AND i1ENLTE. . . . . . . . . . . . . . 8 3. FACTOAL ALILEGATIONS . . . . . . . . . . . . . . . 8 A. EPA's Actions are in Derogation of the Express Terms of the Radon Act . . . . . . . 8 4

B. The classification of ETS as a Group A Carcinogen is Arbitrary and Capricious . . . 10 1. EPA's Analysis of ETS Epidemiology Does Not Support a Group A Class if ication . . . . . . . . . . . . 10 a. The Epidemiologic Studies . . . . . 12 (i) Chance . . . . . . . . . . . 12 (ii) Confounding . . . . . . . . 15 (iii) Bias . . . . . . . . . . . . 17 ( iv ) Strength . . . . . . . . . . 18 (v) Dose-Response . . . . . . . 20 (vi) Consistency . . . . . . . . 20 b. EPA's Meta-Analysis of Epidemiologic Studies Provides No Basis for a Group A Classification . . . . . . . . . . 21 2. EPA Improperly `:tlied Upon a Proxy Substance to Justify Its Group A Classification . . . . . . . . . . . . 25 C. EPA Failed to Follow Itt Own Guidelines . . 28 1. Risk Assessment Guidelines . 2. Exposure Assessment Guidelines . . . . 33 D. Classification of ETS as a Group A Carcinogen Constitutes Final Agency Action . 35 E. Plaintiffs Have Been Injured By EPA's Actions . . . . . . . . . . . . . . . . . . 37 4. CLAIMS FOR RELIEF A. COUNT I - EPA Lacked Authority Under The Radon Act To Classify ETS As a Group A Carcinogen And Illegally Conducted The ETS Risk Assessment . . . . . . . . . . . . 40 B. COUNT II - The Classification Of ETS As a Group A Carcinogen Is Arbitrary, Capricious, And Otherwise Not In Accordance With Law . . . . . . . . . . . . 43 Gb ~ 5 Gl7 O Gt 0D Go ?J

C. COUNT III - EPA Violated The APA By Failing To Comply With Its Own Guidelines . . . . . . . . . . . . . . . . 45 D. COUNT ZV - EPA Violated Due Process By Failing To Comply With Statutory Restrictions, Required Procedures, And Its own Guidelines . . . . . . . • . • . . 46 '1M pARTiEB 5. Plaintiff Flue-Cured Tobacco Cooperative Stabilization Corporation ("Flue-Cured Co-op") is a North Carolina corporation with its principal place of business in Raleigh, North Carolina. Flue-Cured Co-op, which is a cooperative marketing association, is owned by and serves approximately 180,000 growers and workers in Florida, Alabama, Georgia, South Carolina, North Carolina and Virginia, purchasing flue-cured tobacco from growers and selling it to cigarette manufacturers. Flue-Cured Co-op administers the statutory price support program for flue-cured tobacco under contractual agreement with the U.S. Department of Agriculture's Commodity Credit Corporation. 6. Plaintiff The Council for Burley Tobacco, Inc. ("The Burley Council") is a Kentucky corporation with its principal place of business in Lexington, Kentucky. The Burley Council represents growers, dealers, marketing cooperatives and auction warehouses ongaged in the production of burley tobacco and its sale to cigarette manufacturers. 7. Plaintiff Universal Leaf Tobacco Company, Incorporated ("Universal Leaf") is a Virginia Corporation with its principal 6

place of bLisiness-in Richmond, Virginia. Universal Leaf purchases leaf tobacco from growers, processes it and sells it to cigarette manufacturers. 8. Plaintiff Philip Morris Incorporated ("Philip Morris") is a Virginia corporation with its principal place of business in New York, Now York. 9. Plaintiff R.U. Reynolds Tobacco Company ("Reynolds") is a New Jersey corporation with its principal place of business in Winston-Salem, North Carolina. 10. Plaintiffs Philip Morris and Reynolds at all times relevant to this action, were and continue to be engaged in the manufacture and distribution of cigarettes. 11. 'Plaintiff Gallins Vending Company ("Gallins") is a North Carolina corporation with its principal place of business in Winston-Salem, North Carolina. Gallins is engaged in the distritmtitin of cigarettes through its placement and servicing of vending machines containing cigarettes in various retail and other establishments throughout the Winston-Salem, North Carolina area. 12. Plaintiffs have been and will continue to be directly affected and injured by defendants' unauthorized and unlawful decision to classify ETS as a human carcinogen. 13. Defendant EPA is an independent agency of the Executive Branch established by Congress to coordinate and implement 7

federal governmental policy regarding the environment. EPA is subject to the Radon Act and the APA. 14. Defendant Carol Browner is the Administrator of EPA. This action is maintained against her in her official capacity. Administrator Browner ("the Administrator") is responsible for ensuring that the EPA complies vith the terms of the Radon Act, the APA, and EPA policies and quidelines. JIIR2sDICTroN AND VENUE 15. This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1331. Declaratory relief is authorized by 28 U.S.C. 3§ 2201-2202 and Fed. R. Civ. P. 57. Judicial review is aL6,iorized by 5 U.S.C. ;§ 701, g& sec. 16. Venue is proper pursuant to 28 U.S.C. § 1391(e). TACTUAL ALLEGATZONB A. EPAIs Actions are in Derogation of the ZXpress Terms of the Radon Act 17. The Radon Act, which is the sole source of EPA's authority over ETS, authorizes EPA only to establish a research program relating to indoor air quality. Section 404 of the Act states: "Nothing in this title shall be construed to authorize the Administrator to carry out any regulatory program or any activity arber than research, development, and related reporting, information dissemination, and coordination activities specified in this title." dD .1 c~D8 O ~ ~ cn

18. EPA thus has no authority either (i) to regulate indoor air quality, or (ii) to take any action, other than research, in preparation for such regulation. For this reason, the final regulatory classification of ETS as a Group A carcinogen is beyond EPA's authority. Such classification serves only impermissible regulatory purposes and therefore is activity expressly prohibited by the Radon Act. 19. The Radon Act required EPA to establish two new committees "to assist [it] in carrying out the research program~ for radon gas and indoor air quality." The first committee, the "Federal Agency Advisory Committee," was to be composed of representatives from various federal agencies concerned with indoor air. The second committee, the "Radon Act Advisory Committee," was to be composed of representatives from the states, the scientific co=nmunity, industry, and public interest organizations. In violation of the Radon Act, EPA has never estab2ished the Radon Act Advisory Committee. 20. Contrary to the requirements of the Radon Act, EPA initiated, prepared, and reviewed the ETS Risk Assessment without consulting with the Federal Agency Advisory Committee or, obviously, the Radon Act Advisory Committee. 21. As a result of EPA's violation of the requirements of the Radon act, Tspresentatives Trom industry, the states, the scientific commvnity,'amid public interest organizations were precluded from assistirg'EPA in the manner required by Congress. 9

D. The Classificatioa of ZT8 as a oroup A Careiaogen is l,rbitrarv and CApricious 22. To arrive at its classification of ETS as a Group A carcinogen, EPA deviated from accepted scientific principles of chemistry, epidemiology and toxicology as well as its own quidelines for conducting cancer risk assessments. EPA manipulated and «cberry pickedw scientific data, ignored contrary studies, and employed scientific models, assumptions, and methodologies not accepted by the scientific community, including EPA in other contexts. 23. In particular, EPA based its classification of ETS as a Group A carcinogen on (a) epidemiologic studies on ETS and (b) the purported similarities between mainstream smoke and ETS. Neither basis provides a scientific foundation for EPA's conclusion. l. EPA's Analysis of LTB Epidemiology Does Yat EMDOrt a Group A Classification 24. Epidemiology is the study of the occurrence of disease in human populations. Investigators observe patterns of disease occurrence and attempt to statistically correlate disease with potential causes of disease by comparing the incidence or rate of disease in one group (exposed to the factor being studied) to the incidence,or rate in a second group (unexposed to the factor being studied). The results of the studies are reported as statistical correlations-or sssociations which are commonly 10

expressed as relative risks. A relative risk is the ratio of the disease isscidence rate in the exposed group to the incidence rate in the unexposed group. A relative risk of 1.0 indicates that the observed disease incidence rate in the exposed group is the same as that in the unexposed group. A relative risk above 1.0 indicates that the disease incidence rate is greater in the exposed qzvup, while a relative risk less than 1.0 indicates that the disease incidence rate is smaller in the exposed group. 25. In recognition of the complexity of epidemiology and to ensure consistency in its methodology, EPA has adopted certain criteria by which it evaluates epidemiologic data. These criteria are set forth in EPA's own cancer risk assessment guidelines, "Guidelines for Carcinogen Risk Assessment," 51 Fed. .r Reg. 33992 (Sept. 24, 1986) (the "Risk Assessment Guidelines"). The Risk Assessment Guidelines provide that before a conclusion regarding whether an exposure causes a disease (a causal inference) cat! be based upon epidemiologic data, three criteria must be met: (i) the apparent statistical association must be unlikely to be produced by chance; (ii) the possibility of confounding (i.e. the role of other actual or potential factors in the apparent association) must have been considered and ruled out as an explanation for the association; and (iii) there must be no identified bias that could explain the apparent association. 31 FEd. Reg. 33999. In addition, EPA admits in its ETS Risk Assessment that epidemiologic data must also be assessed 11

against other criteria including: the consistency of the data, the stzength or'magnitude of the statistical association, and vhether the data exhibit a dose-response gradient. 26. As is set forth in the following paragraphs, the epidemiologic data relied upon by EPA do not satisfy these criteria and therefore are not sufficient to support a finding that -there is a causal relationship between ETS and lung cancer. According to EPA's own guidelines, such a finding must be made in order to classify a substance as a Group A carcinogen. Indeed the vast majority of the epidemiologic studies relied upon by EPA report no statistically significant overall association between spousal smoking and lung cancer. (a) The Epidc~:_Iocic Studies (i) sbaace 27. The test of statistical significance is crucial to the scientific analysis of epidemiologic data. Without this test, cause nrsd effect conclusions can be erroneously attributed to associations occurring by chance alone, simply due to random sampling variation. Because chance occurrences can never be completely excluded from a study, the likelihood or probability that an observed association could be due to chance is described through the use of tests for statistical significance. Statistical significarce tests can be expressed in terms of a confidence ir,terval which is a numerical range determined by applyirga so-=alled confidence level to the data. A confidence 12

interval calculated with a 95% confidence level, for example, is refert~i to as a 95% confidence interval. An apparent association or relative risk is said not to be statistically significant at the 95% confidence level unless the entire range of the 95% confidence interval for that risk is above or below 1.0. By generally accepted scientific convention, a 95% confidence level is required in epidemiclogic studies to judge an association as statistically significant. 28. EPA analyzed 30 published epidemiologic studies when classifying ETS as a Group A carcinogen. The studies primarily address whether a wow-an's risk of lung cancer may be statistically correlated with whether ber spouse smokes. The _ studies do not measure actual ETS exposure. Instead, they rely on questionnaire responses as to whether a woman's spouse smokes, thereby treating reports of spousal smoking as a surrogate for actual or measured ETS exposure. 29. Df the 30 published ETS studies EPA relied upon, 11 were conducted in the United States. As originally reported, none of the U.S. studies found an overall risk estimate for lung cancer that was statistically significant. 30. Of the remaining studies conducted in seven countries other than the United States, 13 found no overall statistically significant sssociation between spousal smoking and lung cancer as origiaally reported. Put another way, of the 30 studies reviewed by EPA, 24 -- a full 804 -- as originally reported do O Qi GO CD 0

not support the Agency's classification of ETS as a Group A carcirogen. 31. In an attempt to make otherwise non-statistically significant study results appear statistically significant, EPA "reanalyzed" the 30 epidemiologic studies. Specifically, EPA lowered the threshold for achieving statistical significance by lowering the standard 954 confidence level employed by all but three of the authors of the 30 studies to an unorthodox 90% confidence level. In altering the original analyses of the authors of the studies, EPA doubled the possibility that any statistically significant association is simply a random and meaningless event. Its use of the lower 90% confidence level contrasts with its use of the generally accepted 95` ..vel in the 1990 draft of the ETS Risk Assessment and its routine use of studies employing the standard level in other carcinogen risk assessments. 32. Even after zeanalyzing the studies using the lower confidence level, EPA failed to obtain a statistically significant overall association from over two-thirds of the studies. Of the 11 U.5. studies, only one yielded a statistically significant overall association after reanalysis. 33. Other data which EPA refused to account for in its analysis also demomstrate that any observed association between ETS and lung cancer may be due to chance. Nine of the 30 epidemiologic studies of female lung cancer and spousal smoking 14

also gathered data on male lung cancer risk and spousal smoking and, zf these, vnly cne, a Japanese study by Hirayama that is methodologically flawed on other grounds, is statistically significant even at the lower confidence level. Twelve of fourteen reported studies that have examined workplace ETS exposure and lung cancer risk have reported no statistically significant association at the lower confidence level. Similarly, 12 of 13 studies that have examined childhood ETS exposure and adult lung cancer risk fail to show a statistically significant association at that level. 34. The large number of studies, both those considered by EPA and those EPA refused to consider, which report no overall statistically significant association between ETS and lung cancer, overwhelm the few studies that EPA claims demonstrate an association and suggest that those few results may simply be the result of chance. Wben this evidence is coupled with EPA's choice of a confidence level which doubles the risk of an association due to chance being labeled statistically significant, chance becomes the likely explanation for any statistical association claimed by EPA between ETS and lung cancer. (ii) Coafoundiac 35. Confounding of data exists when an association between a disease and in exposure to one agent can be explained, in whole or in part, by an exposure to a second agent that is associated 15

with.batb (a) the disease and (b) the first exposure. The presence of such potential confounding factors undermines the reliability of epidemiologic data because of the difficulty in disentangling one potential risk factor from another. Because human disease causation, and especially chronic disease causation, is an extraordinarily complex issue, epidemioiogic data must be scrutinizsd closely for confounding before it can be relied upon to identify potential risks. 36. Sound science and the Risk Assessment Guidelines require that EPA may not infer causation unless "(t)he possibility of confounding has been considered and ruled = as explaining the associ'-W`ion." 51 Fed. Reg. 33999 (emphasis added). Here again, EPA violated accepted scientific standards and its own guidelines. 37. The scientific literature identifies the following elements, among others, as potential confounders: diet, personal r-edical history, family health history, lifestyle choices, occupational factors, and environmental factors. Some of these potential confounders are of such magnitude that they are large enough to account completely for any apparent association between spousal smoking and lung cancer elaimed by EPA. 38. EPA acknowledged the existence of some potential confounding factors but ignored the Risk Assessment Guidelines' requirement to rule out confounding as an explanation for an association prior to basing a causal inference on epidemiologic 16

data. Instead, EPA deemed the criterion satisfied largely because It claimed to be unable to identify any single confounding factor that in itself would explain the apparent association between ETS and lung cancer which appeared in EPA's analysis. EPA*s methodology falls well short of the Guidelines' requirement to "rul[e3 out" the possibility of confounding. - (iii) JW2 39. Bias in statistics refers to any trend in the design, collection, analysis, interpretation or publication of statistical data that causes or may tend to cause a systematic distortion of the true nature of the relationship studied. 40. Both the Risk Assessment Guidelines and accepted epidemiologic principles reguire that bias must be excluded as an explanation for an observed association before it can be concluded that a statistically significant association exists. Various sources of bias, including publication bias and respondent bias, could explain any association claimed by EPA between ETS and lung cancer. 41. EPA recognized only one source of bias in its Risk Assessment -- the tendency of smokers to misrepresent themselves as nonsmokers ("smoking status misclassification bias") -- and chose to adjust for it by using an unpublished scientific model that ccmtniri Tramerous mathematical and conceptual inconsistencies, including assumptions based on nonrepresentative data. Z t'EPA bad used representative data, EPA's own analysis 17

would nct have resulted in a statistically significant association between ETS and lung cancer. (iv) atreactb 42. Strength refers to the magnitude of an apparent association. Associations of less than 3.0 are generally considered in the scientific community and by EPA to be weak and equivocaZ. Associations under 2.0 are considered to be extremely weak and are far more likely to be an artifact produced by chance, bias or confounding than are stronger associations. The weaker an association, the less reliable it is for evaluating a potential causal relationship. EPA admits as much in stating in its own Risk Assessment Guidelines that 'spidemiologic studies are inherently capable of detecting only comparatively large increases in risk." 51 Fed. Reg. 33996. 43. Of the 30 epideaiological studies analyzed by EPA in connection with its classification of ETS as a Group A carcinogen, 80$ did not report an overall statistically significant association of any magnitude between ETS and lung cancer. Even without consideration of the requirements of statistical significance, all of the studies reported overall relative risks under 3.0 and 21 reported overall relative risks under 2.0. Even when the 11 U.S. studies were pooled by EPA the adjusted relative risk estimate it constructed was only 1.19. 44. Dr. Morton Lippmann, chairman of the committee of the EPA's Science Advisory Board ("SAB") which reviewed the draft ETS 18

Risk Assessment, acknowledged the weakness of the association found by•EPA when he noted to reporters at a press conference called to publicize the draft that the risk of ETS was "probably much less than you took to get here through Washington traffic." 45. In other contexts, EPA has concluded that relative risks greater than the risks claimed by EPA for ETS were insufficisat to classify a potential carcinogen as a Group A carcinogen. For example, in a draft report on electromagnetic fields, the EPA concluded that, "(t]he association between cancer occurrence and exposure to either ELF or RF fields is not strong enough to constitute a proven causal relationship, largely because the relative risks in the published reports have seldom exceeded 3.0 in both childhood residential exposures and in occupational situations." U.S. EPA, Office of Health and Environmental Assessment, Evaluation of the Potential Carcino,genieity•mf E2ectronacnetic Fields, EPA/600/6-90/005A, Workshop Reviev-flraft, June, 1990. The 1.19 relative risk reported for ETS by EPA is less than one-tenth of the 3.0 relative risk found "not strong enough" by the SAB with regard to electromagnetic fields. 46. Because any statistical associations between ETS and lung cancer relied upon by EPA are so weak, it is very likely that they are produced by chance, bias, or confounding. 19 ~ I C7

(v) pose-Reiooase 47. a dose-response relationship mQans that as the extent of exposure, and hence dose, increases, the observed incidence of disease also increases. 48. EPA's Risk Assessment Guidelines note the importance of finding a dose-response relationship when trying to determine if an observad association is causal. 51 Fed. Reg. 33999. EPA attempted to satisfy this criterion by employing another unorthodox approach: the substitution of a test for "trend" for a true dose-response test. A trend test does not measure dose- response and is not an accepted substitute for a dose-response analysis. 49. None of the 30 epidemiologic studies relied upon by EPA shows a statistically significant dose-response relationship. 50. Several studies actually show a reverse dose-response, higher reported levels of spousal smoking are associated with an apparent decreased risk of lung cancer. One study reported a reverse dose-response that was statistically significant. (vi) consisteacv 51. EPA states in the ETS Risk Assessment that the presence of a consistent association across several independent studies in different populations may be evidence of a causal relationship. ConveTSely, a lack of consistency across studies undermines the reliability of any apparent associations and argues against 20

causal inferences. Inconsistency among studies suggests that chance, bias, or confounding has produced the associations reported, not exposure to the substance under assessment. 52. The epidemiologic studies of spousal smoking and ETS are remarkably inconsistent. The studies• results vary widely by geographic area and the magnitudes of ttie reported associations vary-by almost*300t: Without considering the requirement of statistical significance, six studies report associations above 2.0 while six studies report associations below 1.0. One study (wu-Williams) reports a statistically significant neaative association between ETS and lung cancer. (b) EpArs xeta-Analpsis of Zpidemiologic Studies Provides !to Basis for a Group A Classification 53. Recognizing that analysis of the individual epideaiologic studies could not support a Group A classification, EPA combined or pooled select portions of the data from the epidemiological studies using a controversial technique known as meta-analysis to create evidence of an association between lung cancer and ETS. This exercise not only did nothing to eliminate bias, confounding, and methodologic flaws in any of the individual epidemiologic studies, but it introduced mew and different errors and flaws into the analysis. 54. Fir=t, relying solely on data regarding U.S. women and e.mploying 1ts -ororthodox confidence level, EPA calculated a pooled relative risk estimate of 1.19 which is extremely weak. 21 ~ CD O U" ~ Cr C~

If EPA had used consistently its own data selection criteria and the accepted 93t -=mfidence level, its meta-analysis would have yielded no statistically significant association at all. 55. Second, EPA's pertorsance of the meta-analysis violated accepted scientific methodology. Keta-analyses can have utility only when (a) the studies that are to be combined are similarly designed and conducted, " (b) like data are pooled with like data. The epidemiologic studies of spousal smoking and lung cancer do not begin to meet these criteria. For example, some studies are case control studies, and others are cohort studies; some studies classify ex-smokers as smokers and others classify them as non-smokers; and some studies attempt to control for selected confounders and others 3o mct. 56. Third, EPA manipulated, ignored and cherry-picked data for inclusion in the meta-analysis. For example: a. EPA completely ignored two large studies published in the nniLed-States (Stockwell, 1992; Brownson, 1992) although these studies were brought to EPA•s attention prior to its release of the final ETS Risk Assessment. Srovnson is the largest study published on spousal smoking status and lung cancer and was spansored by the Kational Cancer Institute. It reportt To 3T,creased zisk for overall exposure to spoitsalisoking. 22

b. EPA included certain reported data from an incvmplete•-stndy (Pontham, 1991). Only the first three years of the five years scheduled have been completed and publication occurred before additional planned steps of verification had been undertaken. Although EPA included certain data from this incomplete study, •it failed to include data relating to confounding factors which had been collected by the study's authors. c. EPA violated its own criteria for determining what data to select with respect to one study (Janerich). Specifically, EPA used unadjusted risk estimates from bousehold exposure from Janerich while it used adjusted risk estimates from spousal exposure from all other studies from which adjusted risk estimates could be derived. 57. Tourth, TPA failed to adjust adequately for smoking status misclassification bias, which is known to inflate the apparent association observed in studies of spousal smoking and lung cancer. Although EPA acknowledged this one source of bias and purported to adjust for it, EPA used a=uethod of adjustment based on unrepresentative data instead of more representative data. FPA•s ose of these unrepresentative data resulted in an extr"e3y iow and unreal istic rate of ad justment that is not representative of the 4.S. population for this crucial variable. O O

More recent, reliable, and realistic data demonstrate that representative rates of misclassification are between 4 and 6 times larger than the rate used by EPA. 58. The weak apparent association produced by EPA's meta- analysis results from either failures to account for bias and confounding factors or from outcome-determinative choices EPA made vhen selecting metbodology, data and studies to empioy. When even small changes or corrections in the assumptions or methods employed by EPA are made, the results of the meta- analysis change from being statistically significant to being statistically non-significant. For example: a. . EPA could not hav- achieved its alleged statistically significant association between ETS and lung cancer without changing the confidence level. If it had used the correct Janerich data and employed the standard 95% confidence level, its meta-analysis would have resulted in no statistically sianificant association. b. Or, even accepting EPA's switch to the lower confidence level in the face of generally accepted scientific practice, if EPA had included data from the Stockwell and Brownson studies in its meta-analysis, there would similarly be no statistically sianificant association. e. DT, 3? EpA fiad used a realistic and supportable saokez ziaciessitication rate of 5%, no statistically sianificant association would have resulted. m ~ 2 4 OD 0 Cn ~ 0 ~

(2) ZpA Improperly Relisd Upon a Proxy 8ubstance to Justify Its Group A classificatioa 59. EPA also attempted to support its decision to classify ETS as a Group A carcinogen on an independent ground: analysis of a proxy substance. Specifically, EPA claimed that similarities between ETS and mainstream smoke (tDe smoke inhaled by a smoker), coupled with the assumption that any txposure to mainstream smoke poses a lung cancer risk, justified a Group A classification. EPA's classification on this basis is arbitrary and capricious. 60. First, EPA ignored the fact that ETS is not the equivalent of mainstream smoke. ETS is a highly dilute, complex and dynamic mixture of sidestream smoke ("SS"), exhaled mainstream smoke ("MS*) and some diffused tobacco smoke emanating from the tobacco rod. Very few of the chemical constituents identified in mainstream smoke have been identified in ETS in ambient air. The-general physical and chemical properties of the two smokes, inc3udimg particle size, pH, constituent-phase distribution, and other physicochemical traits, differ significantly. 61. As recognized by the public health community, the multiple, pervasive and demonstrable differences between ETS and MS preclude any rational analysis of ETS using a proxy study of data on mainstreaa smoke. The Surgeon General concluded in 1986 that iaticn4lzdge of MS chemical composition is of limited assistance in evaluating ETS: "Comparison of the relative 25

concentrations of various components of SS and MS smoke provides limitefl Insights concerning the toxicological potential of ETS in comparison with active smoking." (USPHS, 1986 at 24.) 62. Similarly, when requested in 1986 by the EPA and others to review ETS and health studies, the National Research Council concluded that data on MS do not provide a basis for predicting ETS exposure effects: -Bbecause the physicochemical nature of ETS, MS, and SS differ, the extrapolation of health effects from studies of MS or of active smokers to nonsmokers exposed to ETS may not be appropriate. . . ." (NRC, 1986 at 7-8.) 63. EPA itself concedes and relies upon the substantial physicochemical differences between MS and ETS elsewhere in the Risk Assessment. For example, in Chapter 6, wni"i purports to calculate a population risk of lung cancer from passive smoking, EPA states: This assumption icomparing MS and ETS to calculate lung cancer risks] may not be tenable, however, as MS and SS differ in the relative composition of carcinogens and other components identified in tobacco smoke and in their physico- chemical properties in general.... 64. Second, even if ETS and MS were nearly identical, the immense quantitative differences between ETS exposure and cigarettie smoking vould independently preclude reliance an proxy analysis. There is strong evidence aaainst EPA's assumption that any exposure to ITS, no matter bow small, poses a cancer risk. 26 GO O t!1 CD W

a. Certain ETS constituents such as particulate mattez and ambient nicotine can be measured in the ambient air. Based on those data, scientists have consistently estimated that an E"TS exposed nonsmoker is exposed to the range of one to five cigarette equivalents per year. b. According to a recent published review, data from several epidemiologic studies on active smoking suggest that smoking four to five cigarettes per g,ay is not likely to be associated with a statistically significant increased risk of lung cancer. c. Differences in retention can further expand these dosimetric differences. For example, it is estimated that the average ETS exposed person appears to retain between 10,000 and 100,000 times less smoke particulate matter than a cigarette smoker. d. EPA's assunption, that no threshold exists for ETS exposure, Telies -solely on active smoking studies which have as their lowest exposure range 1-7, 1-9, 1-14 or <20 cigarettes smoked per day. All of these ranges are far in excess of the highest dose conceivably attributable to ETS. 65. Moreover, in the absence of a clear congressional mandate to the contrary, EPA is required to make a finding that a risk is Bignifiearrt ,before taking such action as classifying ETS as a Zrflup Acarcirogen. EPA•s "no-threshold" assumption is an insufficient basis vpon which to make such a finding. Indeed, if 27

the pressnca in any quantity of a chemical reported in mainstream smoke were a sufficient basis for declaring a substance to be a Group A carcinogen, EPA could similarly classify outdoor air, hamburgers, milk, peanut butter, and a host of other substances as Group A carcinogens. C. Zpa laiied to tollov 2ts ovm Ouidelimes f>6.' In classifying ETS as a human carcinogen, EPA followed neither its Risk Assessment Guidelines, developed specifically for classifying the carcinogenic potential of pollutants, nor its Guidelines for Exposure Assessment," 57 Fed. Reg. 22888 (May 29, 1992) ("Exposure Assessment Guidelines"). i. Risk Assessmemt Guideliaes 67. EPA issued the Risk Assessment Guidelines to ensure that the Agency follows uniform scientific standards and procedures in evaluating suspected carcinogens. The Risk Assessment Guidelines were designed to enhance the scientific quality and the public's understanding of EPA risk assessments: The purpose of these Guidelines is to promote quality and consistency of carcinogen risk assessment within the EPA and to inform those gutside the EPA about its atsmroach to parcinoaen zisk assessment. These Guidelines emphasize the broad but essential aspects of risk assessment that are needed by experts in the various disciplines required (e.g., toxicology, pathology, pharmacology, and statistics) for carcinogen risk assessment. 51 Fed. Reg. at 33993. (F.mphasis added.) The guidelines set forth the scies,tifiz principles and procedures that EPA has established as necessary for conducting a risk assessment and for 28

classifyirg potential carcinogens. Members of the general public, including plaintiffs, have a legitimate expectation that the guidelines will be followed and are justified in relying on them. 68. As set out above, EPA has violated the Risk Assessment Guidelines by failing to rule out the possibility that any association between spousal smoking and lung cancer is attributable to chance, confounders, or bias, and by failing to consider the absence of a strong association or a dose-response relationship. In addition, the EPA's classification of ETS as a Group A carcinogen violates the Risk Assessment Guidelines in at least six other respects. 69. First, the Risk Assessment Guidelines require EPA to ensure that "[s]tudies are evaluated according to sound biological and statistical considerations and procedures." 51 Z". $gg. at 33994. EPA violated accepted statistical principles by performing a meta-analysis on noncomparable data and by using an unorthodox confidence level in place of the scientifically accepted 95% level. Moreover, EPA engaged in unjustified biological assumptions in applying studies on mainstream smoke to ETS. 70. Second, the Risk Assessment Guidelines require that the EPA's evidence from epidemiologic studies be Ksufficient" before ETS can be classified as d Group A carcinogen. 51 Fed. Reg. at 34000. All of the epidemiologic studies conducted in the United (]o 29 .1 00 O . CP Cd O ~

States and 80% of all studies reviewed by the EPA report no overall statistically significant association between ETS and lung cancer using the standard confidence level. The few statistically significant associations that are reported are weak and inconsistent, and bias and confounding cannot be excluded as explanations for them. Nor does the EPA's meta-analysis yield a statistitaliy significant association (even using EPA's unjustifiable lower confidence level) when EPA's methodology is applied consistently, fairly and without computational error to the available data. If (1) the Brownson and Stockwell studies are added to the meta-analysis, (2) the appropriate figures are derived from the Janerich study, and (3) representative data are employed to imake the smoker misclassification adjustment, the meta-analysis does not produce any increase in risk from ETS exposure, much less a statistically significant one. The existing tpidemiologic evidence is not "sufficient" to support EPA's vronclusions. 71. Third, the Risk Assessment Guidelines require EPA to give full consideration to "all relevant scientific information." 51 Fed. Reg. at 33992. However, EPA refused to consider two published epidemiologic studies on spousal smoking status and lung cancer which, if included in EPA's meta-analysis, would, in and of tbEmselves, lhave altered EPA's conclusions. EPA also failed to tonsidez ti) the workplace exposure data reported in 11 of the 30 studies examined in the risk assessment, (ii) the data 30

on home exposure during childhood reported in 10 of the 30 studies, (iii) the data from numerous published studies which have measured ETS constituents in indoor air, (iv) the data on the physical and chemical distinctions between FTS and MS, and (v) data on identified sources of bias and confounding factors. 72. Fourth, the Risk Assessment Guidelines require the EPA to Mfully 'present" all relevant scientific information in the ETS Risk Assessment. 51 Fed. Reg. at 33992. The ETS Risk Assessment fails to "fully present" critical scientific information. For example, the EPA has not informed the public of the fragility of the meta-analysis. That analysis depends entirely, among other things, on (1) the determination to evaluate chance at a lower confidence level; (2) the exclusion of the largest U.S. study ever; and (3) the employment of a series of unjustified assumptions and unproven and unaccepted methods. . 73. Fifth, the Risk Assessment Guidelines require the EPA to "use tTie most scientifically appropriate interpretation to assess risk." 51 Fed. Reg. at 33992. EPA did not. Instead, EPA used an unconventional statistical significance level, combined noncomparable studies in a meta-analysis, relied upon inappropriate assumptions to manipulate the data, such as when adjusting for smoker misclassification, and inappropriately analogiiea 'M exposure to cigarette smoking. Had EPA employed "the most scientifically appropriate interpretation" of the available data, it could not have classified ETS as a Group A carcinoge 31

74. Sixth, the Risk Assessment Guidelines require EPA scientists to'"i'dentify the strengths and weaknesses of [the ETS Risk Assessment] by describing uncertainties, assumptions and limitations, as well as the scientific basis and rationale" for the assessment. 51 Fed. Reg. at 33992. EPA failed to acknowledge -- let alone describe - the numerous uncertainties, assumptions, and limitations demonstrated in the foregoing paragraphs, despite having received detailed, vritten comments relating to all of them well in advance of the release of the ETS Risk Assessment. 75. The Guidelines allow a Group A classification only when there is sufficient evidence from epidemiologic studies to support a causal relationship between exposure to the agent being classified (in this case ETS) and cancer. The Guidelines do not provide for classification of an agent as a Group A carcinogen based vpon epidemiology studies of exposure to some other agent (such as MS) . 76. No other substance has been classified by EPA as a Group A carcinogen based on (i) a clear majority of epidemiologic studies finding no statistically significant association or (ii) extrapolation of data from one substance to another. EPA's own Risk Assessment Guidelines prohibit EPA from classifying ETS as a human eaTtirogen. 3 2 0~ ~ m O Gr±. CD O CD

(2) ZXposure Assessmsnt Cuidelimes 77 'In Z992 , the EPA issued its Exposure Assessment Guidelines, which govern EPA exposure assessments and their use in risk assessments. Like the Risk Assessment Guidelines, the purposes of the Exposure Assessment Guidelines are "to promote consistency and technical quality in risk assessment, and to ensure that the risk assessment process is maintained as a scientific effort separate from risk management." 57 Fed. Reg. at 22888. 78. The ETS Risk Assessment violated the Exposure Assessment Guidelines in at least three respects. a. First, the Exposure Assessment Guidelines require that "exposure estimates along with supporting information . . . be fully presented in Agency risk assessment documents." 57 Fed. Reg. at 22688. Numerous studies providing ETS exposure estimates are omitted from the ;tisk Assessa:ent. b. Second, the Exposure Assessment Guidelines direct EPA to "identify the strengths and weaknesses of each assessment by describing uncertainties, assumptions, and limitations, as well as the scientific basis and rationale for each assessment." 57 Fed. Reg. at 22888. EPA made no ei'fortto identify the r=erous uncertainties, assumptions and 3imitations of its exposure assessment, including the 33

fundamental flaw that none of the epidemiologic studies actually,zeasttred ETS exposure. c. Third, the Exposure Guidelines sequire that «[e]xposure information must be clearly linked to the hazard identification and dose-response relationship." 57 Fed. Reg. at 22905. The ETS Risk Assessment is uniquely deficient in this regard. The exposure studies that are discussed in the Risk Assessment in Chapter 3 are never linked to the hazard identification in Chapter 5. EPA did not construct a dose-response gradient - one of the mandated steps in conducting a risk assessment. 79. irw's reliance on gross ETS exposure surrogate information is inconsistent with its treatment of exposure requirements in risk assessments for other alleged human carcinogens. For example, in rejecting a review draft on dioxin, EPA's Science Advisory Board concluded that "without good exposure data, the epidemiologic studies are meaningless." SAB ad hoc Panel on Dioxin, "Panel Report Review Draft on Dioxin," U.S. EPA, November, 1989. Similarly, the SAB criticized a review draft on diesel emissions, noting that "due to the lack of actual data on exposure to diesel exhaust . . . the evidence of carcinogenicity in humans is considered to be limited for diesel exhaust sxposure.` S?,8 Iftnel on Diesel Emissions, "Health Assessment Document for Diesel Emissions," Workshop Review Draft EPA/b0D/8-90/57A, July 1990. 34

D. Classification of ZTS as a Group A Careinocen Constitutes Pinal Acer-cy 7-ction 60. In classifying and publicizing ETS as a Group A carcinogen, EPA expected and intended its action to have a substantial regulatory impact resulting in the restriction of smoking in the workplace and in public. Then-EPA Administrator Reilly stated that classifying FTS as a buman carcinogen was "one of the biggest decisions I ever will make." He expressed the hope that the classification "will have profound reverberations in the country" and that no further action by any other government agency will be necessary for the EPA report to have an impact because "the liability question will drive it." Mr. Reilly concluded that "the government has spoken on the question." 81. EPA's decision to classify ETS as a Group A carcinogen has resulted in and continues to result in exactly the regulatory impact intended by EPA. By classifying ETS as a human carcinogen, EPA exertedtremendous pressure on both private and public entities to sestrict smoking in the workplace and in public -- pressure that the entities believed could not be ignored. Specifically, as a direct result of the EPA's classification of ETS as a Group A carcinogen, private entities, fearing liability, have felt compelled to institute restrictions or total bans an smolci.ng in their buildings. The ETS Risk Assessment also has prompted public agencies to institute or consider j.astituting sinilar smoking restrictions or bans. 35

82. All these actions were taken and continue to be taken in express reliance on the soundness of EPA's science underlying its decision to classify ETS as a Group A carcinogen -- science that, as detailed above, was flawed and unsound. As a result of the release of the ETS Risk Assessment, plaintiffs suffered substantial and immediate bars, including false disparagement of their product and loss.of business and good will. 83. No other avenue of redress exists for plaintiffs to undo the harm that has been done other than review under the APA. Unless the classification of ETS as a Group A carcinogen is reviewable under the APA, EPA will be able to arrogate to itself enormous power over American industry by condemning products and substances, no matter bow flawed its actions, with no opportunity for judicial review. Neither the APA nor the Radon Act was intended to give EPA such authority over industry and society. 84. For all these reasons -- the regulatory purpose and effect.of the tlassification, tbe injury it caused to plaintiffs, and its nonreviewability in any other forum -- the classification of ETS as a Group A carcinogen is "equivalent" to "an agency rule, order, license, sanction, (or] relief" under Section 551(13) of the APA. 85. EPA's classification of ETS as a Group A carcinogen also constitutes agency action that is "final" within the meaning of Sett.i- _7La cf tAe APA: OD ~ 36 GO C C!ri Co N W

a. EPA intended that its January 7, 1993, •classificaticn•of ETS as a Group A carcinogen be a final and unequivocal agency conclusion and decision. As Administrator Reilly stated, "It]he government has spoken on the question." b. The ETS Risk Assessment embodying the -classification was formaily released by the EPA administrator. c. EPA is contemplating no further action regarding the classification of ETS as a Group A carcinogen. 2. 4laintiffs save Been Znjured Bv BPA,s Aetions 86. The classification of ETS as a Group A carcinogen was intended to and in fact did falsely disparage plaintiffs' products and their reputations and resulted in a loss of good will. The classification also was intended to and in fact did result in the imposition of greater smoking restrictions in the workplaoe -and public areas. These smoking restrictions, based on a classification of ETS as a Group A carcinogen without scientific foundation, have resulted and will continue to result in decreased sales and use of cigarettes and, concomitantly, decreased use and sales of tobacco. For example, plaintiff Gallins has removed cigarette vending machines from premises where they had been placed aat the request of the owners of the premises. -on information +end belief, it has also been precluded 3 7 0O 4 00 O c1'; CJ N 0

from placing machines in some new locations as a result of EPA's actions. 87. As a result of the labeling of ZTS as a Group A carcinogen, other private entities and governments throughout the country have already undertaken action or are actively considering taking action to restrict or prohibit smoking, as evidenced below: a. On June 3, 1993, Postmaster General Marvin Runyon, relying specifically on EPA's classification of ETS, ordered a nationwide ban on imoking in all 40,000 Postal Service facilities effective June 13, 1993. b. Numerous private employers, including Raytheon Co., Graco Inc., Abbott Laboratories, Virginia Power, Southern California Edison Co., Beltz Enterprises, Miles Inc., Public Service Electric and Gas (New Jersey), New £ngland Telephone and Greyhound Lines have instituted reviews of smoking policies, expanded workplace smoking restrictions or instituted total workplace smoking bans. For example, on March 1, 1993 Primerica Corporation banned smoking in all of its subsidiaries "in response to" EPA's actions. In addition, Fortune reported that Pepsico, Federal Express, 1)iPont, US West and Ralston Purina are ilinstrative of companies that are "getting tougher... Gt I Go 38 b t1t t0 N C11

aow that the [EPA) has declared that secondhand smoke causes cancer." c. Restaurants have also initiated smoking bans. For example, in specific zeliance on EPA's classification, the California Restaurant Association, on January 7, 1993, endorsed legislation which would ban smoking in the workplace and all public places. d. The Board of Directors of the Building Owners and Managers Association International, representing more than 5 billion square feet of North American office space, passed a resolution supporting a federal ban on smoking in the workplace. e. The Governors of Kentucky and California have already issued executive orders that make those states' public smoking laws more restrictive. Other states, including Colorado, Delaware, Hawaii, Illinois, Iowa, Kansas, Maryland, Missouri, Minnesota, Montana, Nebraska, New York, Ohio, Texas, Utah, Vermont, and Virginia have proposed legislation to ban or restrict smoking in workplaces and other public areas. f. Legislation was introduced in Congress that would prohibit smoking in all structures owned or leased for use by a federal agency, including the Executive and Judicial Branches, "Preventing Our Federal Building Workers and visitors Exposure to Deadly Smoke (PRO-FEDS) Act of 1993." 39

g. Organizations such as Smokenders have contacted major companies and, specifically citing EPA's Group A classification of ETS, urged them to initiate total smoking bans claiming that the EPA has determined that ETS "causes thousands of cancer deaths among nonsmokers each year." 88. Plaintiffs' pervasive, ongoing harm is the result of EPA•s .ualawful conduct, which has occurred and will continue to occur unless this Court qrants the relief plaintiffs seek in this complaint. COmrr I EPA I+AClCED AQTEORITY IINDER TEE RADON ACT TO CLASSIFY ET8 AS A GRODP A CARCIZIOGEN AND ILLEGALLY CO1+'DDCTED TIE FTB RI6R ASSESS?:ENT 89. Plaintiffs incorporate herein by reference paragraphs 1 through 88 of the complaint. 90. An administrative agency has no power to act unless and until Congress confers power upon it. To the extent EPA has any authority over ETS, it derives from the Radon Act. 91. Section 401 of the Radon Act provides EPA with authority restricted to conducting "research, development, and related reporting, information dissemination, and coordination activities." The Radon Act expressly bars the EPA from carrying out "any regulatory program." 92. EPA, purporting to rely on the Radon Act, has classified ETS as a•Group A" carcinogen and conducted and issued the ETS Risk Assessment. 40

93. Classification of ETS as a Group A carcinogen does not constitute research as authorized by the statute. EPA's classification of ETS as a Group A carcinogen serves no legitimate research purpose, but is designed and intended solely to achieve a substantial regulatory impact and effect. EPA's classification of ETS bas in fact had a substantial regulatory impact znd sffsct. - 94. EPA exceeded its statutory authority under Sections 403 and 404 of the Radon Act by classifying ETS as a Group A carcinogen. 95. EPA further exceeded its authority under the Radon Act by deciding to classify ETS as a Group A carcinogen without making a finding as to whether exposure to ETS poses a significant risk. 96. EPA also violated the Radon Act by not properly establishing the Radon Act Advisory Committee mandated by Section 403(c) of the Radon Act. Under the Radon Act, that Committee is to provide EPA with the input from industry and the public to assist the defendants in carrying out research programs. Because no such committee was ever formed, EPA's classification of ETS and the ETS Risk Assessment also violate the Radon Act and exceed EPA's statutory authority. 97. 'Under Section 403(c) of the Radon Act, the Administrator was also reguired to establish a Federal Agency Advisory Committee composed of individuals representing Federal 41 ~ GD C C11 (0 N 00

Agencies. Although the EPA Administrator has designated The Committee on Indoor Air Quality (CIAQ) as this Federal Agency Advisory Committee, the CIAQ has not assisted the Administrator in carrying out the research program. For this additional reason, EPA's classification of ETS and the ETS Risk Assessment further violate the Radon Act and exceed EPA's statutory authority. 98. EPA's action in conducting and issuing the ETS Risk Assessment is "in excess of statutory jurisdiction, authority, or limitations or short of statutory right" and, therefore, is in derogation of the public interest and should be held unlawful and set aside in accordance with Section 706(2) of the APA. 99. As a direct and proximate cause of EPA's unlawful acts, plaintiffs have been seriously injured as alleged herein. WHEREFORE, plaintiffs pray this Court grant plaintiffs the following relief: ZA) 3'o declare that EPA's classification of ETS as a Group A carcinogen and its performance and issuance of the ETS Risk Assessment exceeded EPA's authority prescribed by Sections 403 and 404 of the Radon Act, and thereby contravened Section 706(2)(C) of the APA; (B) To declare that any ETS research programs, including the Tesults thereof, zonducted pursuant to the authority of the Radon l,ct taithout the assistance of the Federal Agency Advisory Committee or the assistance of a properly constituted Radon Act 42

Advisory Committee are unlawful because they are in excess of the authosityof tbe defendants; (C) To declare that the classification of ETS as a Group A carcinogen and the issuance of the ZTS Risk Assessment were unlawful and in violation of statutory procedures; (D) To grant an injunction requiring EPA to withdraw Sts classificatioa of STS as a Group A carcinogen and to withdraw its ETS Risk Assessment; and (E) To grant plaintiffs such additional relief that the Court may deem just and proper. COMPT II T8E CLASSIPICATION OT LTS AS A 6ROIIp A CARCIliOGEN IS ARBITR7lRY, CAPRICIOIIBe M OTEERWISE NOT Iw 1lCCORDIWCE 1PIT8 LAW 100. Plaintiffs incorporate berein by reference paragraphs 1 through 88 of the complaint. 202. EPA's decision #o classify ETS as a Group A carcinogen and the tinderlying ETS RiskAssessment was based on incomplete, irrelevant, and inconsistent data. 102. In classifying ETS and promulgating the ETS Risk Assessment, EPA ignored available, persuasive scientific data contrary to its conclusions. 1t13. The classification of ETS as a Group A carcinogen and the ETS Risk Assessmgnt nze ftsed on models, assumptions, and metbodo3cgies tfiat are inaccurate, flawed, and not accepted by the scientific commzmity. © C!1 W N a

104. In classifying ETS and promulgating the ETS Risk Assessment, TPA violated its published guidelines and its standard procedures and methodologies when use of EPA's guidelines and standard procedures and methodologies would not support its predetermined classification. in classifying ETS as a group A carcinogen, EPA also violated the limits of its delegated power by failing to make a finding as to whether exposure to ETS poses a significant health risk. 105. The classification of ETS as a Group A carcinogen and the ETS Risk Assessment are not supported by the existing state of scientific or iaedical knowledge, and are therefore arbitrary and capricious. 106. As a direct and proximate cause of defendants' arbitrary and capricious acts, plaintiffs have been seriously injured as set forth herein. iThIER£FGRE, plaintiffs pray this Court grant plaintiffs the follos.-ing -Telief: (A) To declare that the ETS Risk Assessment and the resulting EPA designation of ETS as a Group A carcinogen are unlawful, arbitrary and capricious; (B) To grant an injunction requiring EPA to withdraw its classification of ETS as a Group A carcinogen and to withdraw the ETS Risk l,sses=merrt upon vhich that classification is based; and (C) To gzarlt plaintiffs such additional relief that the Court may deem Jmst and pTC7,per. 44

COQNT III ZPli VIOIJITED T8E 71PA BY lAZLING TO COMPLY RITH ITS O1PN GQIDELZNEB .107. Plaintiffs incorporate herein by reference the allegations contained in paragraphs l through 88 of this complaint. 108. In,classifying ETS as a human carcinogen, EPA violated the Risk Assessment Guidelines. 109. In classifying ETS as a human carcinogen, EPA violated the Exposure Assessnent Guidelines. 210. EPA violated its own guidelines as alleged above, individually and collectively, for the purpose of reaching a desired conclusion (that ETS Ss a Group A carcinogen) that could not have been reached but for such violations. 111. As a result of EPA's violations of its own guidelines, the classification of ETS as a Group A carcinogen was "without observativnzf prozedure required by law" and therefore violated Section 706(2)(D) of the APA. 112. As a direct and proximate cause of EPA's unlawful acts, plaintiffs have been seriously injured as alleged herein. QO ~ 45 (b d CJ1 ~

ti7HEREFCIRE, plaintiffs pray this Court grant plaintiffs the followirg -relief: • (A) To declare that EPA's classification of ETS as a Group A carcinogen and the ETS Risk Assessment are in violation of Section ?06(2)(D) of the APA; (8) To grant an injunction requiring EPA to withdraw its classification of FTS as a Group A carcinogen and to withdraw its ETS Risk assessment; and (C) To grant plaintiffs such additional relief that the Court may deem just and proper. COUNT t0 EPA VIOLATED DUE pROCESS BY TAILING TO COMPLY lITH BTATDTORY REBTRICTIONS. REQDIRED pROCEDIIRfB, hi+'D ITS OWN GUIDELINEB 113. Flaintiffs incorporate herein by reference the allegations contained in paragraphs 1 through 68 of this complaint. 11-0. Z*n classifying E4'S as a Group A carcinogen and conducting the ETS Risk Assessment, EPA violated its limited grant of authority under the Radon Act. 115. EPA further violated the Radon Act by failing to establish the Radon Act Advisory Committee and classifying ETS as a Group A carcinogen and performing the ETS Risk Assessment withont assistaree frvm the pederal Agency Advisory Committee. Go 01i ~ 46 ~ CD N Ca

116. In classifying E'TS as a Group A carcinogen and issuing the ITS Risk'assessment, EPA also violated its Risk Assessment Guidelines, and its Exposure Assessment Guidelines. 117. Plaintiffs bad a legitimate expectation that EPA would comply with the Radon Act and with EPA's own guidelines. Plaintiffs relied on the provisions of the Radon Act and EPA's quidelines for protection from arbitrary and capricious actions, including classification of ETS as a Group A carcinogen and the underlying risk assessment. 118. EPA was only able to reach its desired conclusion by violating the Radon Act and the agency's guidelines. EPA could not have concluded that ETS was a Group A carcinogen but for such violations. 119. As a direct and proximate cause of EPA's violations of the Radon Act and the agency's guidelines, plaintiffs have been seriously injured and deprived of property interests, including but not limited to loss of good will and sales. WHEREFORE, plaintiffs pray this Court grant plaintiffs the following relief: (A) To declare that EPA's classification of ETS as a Group A carcinogen and the ETS Risk Assessment violate the guarantee of due process of law in the United States Constitvtion,'U.5. Const. tmend. V.; 47

(B) To grant an injunction requiring EPA to withdraw its-classificatian lof ETS as a Group A carcinogen and to withdraw its ETS Risk Assessment; and (C) To grant plaintiffs such additional relief that the Court may deem just and proper. Of Counsel: SMITH, ANDERSON, BLOUNT, DORSETT, MITCHELL & JERNIGAN Respectfully submitted, ewey W. JQells 2500 First Union Capital Center N.C. State Bar No. 4645 Post Office Box 2611 Keith W. Vaughan Raleigh, North Carolina 27602-2611 N.C. State Bar No. 6895 Attorneys for Flue-CurP1 Tobacco Jeffrey L. N.C. State Furr Bar No. 14107 Cooperative Stabilization WOMBLE CARLYLE SANDRIDGE Corporation & RICE BERRY & FLOYD, P. S. C. 4 07 North Ma in Street Post Office Box 245 New Castle, Kentucky 0050 1600 Southern National Financial Center 200 W. 2nd Street Winston-Salem NC 27102 (919) 721-3600 Attorne s for Plaintiffs Attorneys for The Council for Burley Tobacco, Inc. y Universal Leaf Tobacco Company, Inc., Phili Morris Incor orated p p WILLIAMS, MULLEN, CHRISTIAN AND 1021 East Cary Street Richmond, Virginia 23219 Attorneys for Universal Leaf Tobacco Company, Inc. ARNOLD & PORTER 1200 New 8Ampshire Avenue, ll.V. Washington, D.C. 20036-6885 BEVERIaGE i DIAMOND 1350 pI" Street, N.W. Washington, D.C. 20005 DOBBINS and R.J. Reynolds Tobacco 48 ompany ames K. Dorsett, Jr. N.C. State Bar No. 1212 James D. Blount N.C. State Bar No. 378 SMITH, ANDERSON, BIAU'NT, DORSETT, MITCHELL & JERNIGAN 2500 First Union Capital Center Post Office Box 2611 Raleigh, NC 27602-2611 (919) 821r1220 Attorneys for Plaintiffs Flue-Cured Tobacco Cooperative Stabilization Corporation and The Council for Burley Tobacco, Inc. 87805925

SHOOK, HARDY & BACON One Kansas ' City 3?lace 1200 Main Street Kansas City, Missouri 64105-2118 Attorneys for Philip Morris Sncorporated JONES, DAY, REAVIS & POGUE North Point 901 Lakeside Avenue Cleveland, Ohio 44114 WOMBLE CARLYLE SANDRIDGE & RICE 1600 Southern National Financial Center 200 W. 2nd St. Winston-Salem, North Carolina 27102 Attorneys for R. a. Reynolds Tobacco Company ALLMAN SPRY BUMPHREYS LEGGETT & HOWINGTON, P.A. Suite 700 380 Knollwood Street Winston-Salem, North Carolina 27113 Attorneys for Gallins Vending Company I Richard . Howing n N.C. State Bar No. 5159 ALIMAN SPRY HUMPHREYS LEGGETT & HOWINGTON, P.A. Suite 700 380 Knollwood Street Winston-Salem NC 27103 (919) 722-230d Attorneys for Gallins Vending Company 49

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