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Philip Morris

Report on Recent Ets and Iaq Developments

Date: 03 Nov 1995
Length: 47 pages
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Abraham, S.
Alarie, Y.
Banham, R.
Bayard, S.
Beaumont, J.
Beaumont, M.
Becklake, M.R.
Berg, A.T.
Berlin, J.A.
Bond, K.
Bottorff, D.
Bredfeldt, R.C.
Browner, C.
Burdick, E.
Burke, T.
Cain, S.R.
Clinton
Colditz, G.A.
Covas, M.
Crain, E.F.
Cruz, S.
Cys, M.
Daniels, L.A.
Dear, J.
Debon, M.
Demissie, K.
Diamond, M.
Dole
Dunbar, J.T.
Dwyer, T.
Ernst, P.
Farland, W.
Feingold, R., J.R.
Flatman, G.
Fowkes, Fgr
Goldman, L.
Gross, A.J.
Hanley, J.A.
Hauser, W.A.
Hertzberg, T.
Hokfelt, T.
Holgert, H.
Holmes, T.M.
Hutchison, K.B.
Jinot, J.
Joseph, L.
Kassebaum, N.
Klesges, R.C.
Lagercrantz, H.
Lee, A.J.
Lewit, E.M.
Locher, U.
Martone, T.
Mcghee, L.A.
Mengersen, K.
Merrilees, M.J.
Mosteller, M.
Nexo, B.A.
Nielsen, G.D.
Oshaughnessy, P.
Pagedove, B.
Penn, A.
Ponsonby, A.L.
Poulsen, O.M.
Ray, J.W.
Repace, J.L.
Roberts, T.
Salomon, M.E.
Samet, J.
Schutze, G.E.
Shapiro, E.D.
Shinnar, S.
Silberman, R.
Snyder, C.A.
Taylor, S.
Vineis, P.
Vittone, J.
Warner, K.E.
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Shb, Shook,Hardy & Bacon
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2056149046/9092

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0 SHOOK, HARDY& BACON L.L.P REPORT ON RECENT ETS AND IAQ DEVELOPMENTS November 3, 1995 • SHB
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• • REPORT ON RECENT ETS AND IAQDEVE.LOPMENTS __zssUE 1io - IN THIS ISSUE - IN THE UNITED STATES REGULATORY AND LEGISLATIVE MATTERS • Judge Vittone extends OSHA post-hearing comment deadline, p. 1. • OTA finds OSHA overestimates regulatory costs, p. 1. • Browner requires consideration of risk to children in all EPA risk assessments, p. 2. • New regulatory reform bills introduced in Senate, p. 3. STATE AND LOCAL GOVERNMENTS • Pennsylvania legislators consider public and workplace smoking ban, p. 6. • Doorway smoking ban takes effect in Palo Alto, California, p. 6. OTHER DEVELOPMENTS • Military facility smoking ban suspended during peace negotiations in Ohio, p. 10. • U.S. hotels increase availability of non- smoking rooms, p. 10. SCIENTIFICITECHNICAL ITEMS • ASHRAE winter meeting announced, p. 11. • Four-part exchange about EP.', Risk Assessment on ETS, p. 11. • Bias in self-reports about amount smoked viewed as potential source of inaccuracy for ETS studies, p. 13. • Repace, Jinot and Bayard manuscript on indicators of ETS exposure in the work- place submitted to OSHA docket, p. 14. ETS-RELATED LITIGATION BROUGHT BY CIGARETTE MANUFACTURERS • EPA seeks protective order in response to informal discovery filed by plaintiffs, p. 7. ETS-RELATED LITIGATION AGAINST CIGARETTE MANUFACTURERS • Broin plaintiffs file brief in opposition to defendants' appeal of class certification, p. 7. ETS/IAQ LITIGATION NOT INVOLVING CIGARETTE MANUFACTURERS • Three collective bargaining cases involving smoking policies, p. 8. • Ohio court dismisses prisoner ETS damages case, p. 9. IN EUROPE & AROUND THE WORLD REGULATORY AND LEGISLATIVE MATTERS • Restaurant smoking restrictions adopted in Rosario, Argentina, p. 15. • European Parliament calls for restrictions on smoking in public places, p. 15. OTHER DEVELOPMENTS • UK Federation of Tour Operators acts to prohibit smoking on 90 percent of chartered flights, p. 16. • Smoking restrictions implemented at United Nations headquarters, p. 17. 0
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• - TABLE OF CONTENTS - Issue 110 - - _ November_3_ ,_ 1995 IN THE UNITED STATES - REGULATORY AND LEGISLATIVE MATTERS OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA) [1] [2] [3] Deadline for Second Phase of Post-Hearing Comments Extended ........................................... 1 OTA Concludes OSHA's Cost Analyses May Be Overestimated ......................... ......... •...... .... 1 Stakeholders Consider Proposed Safety and Health Standard ..................... __•............. ______. 1 [4] Senate Task Force Seeks Regulatory Reform through OSHA Reform Legislation .................... 2 ENVIRONMENTAL PROTECTION AGENCY (EPA) [5] Browner Mandates Consideration of Risks to Children.......... [6] Government Officials Discuss Regulatory Reform at Risk Assessment Conference.... •.._•. 2 [7] New VOC Sampling Method Offers Increased Accuracy ............................... ..................... _•• 3 104TH CONGRESS: REGULATORY REFORM [8] House Committee Approves Sunset Legislation; New Regulatory Reform Measures Introduced in Senate .....................................................--••-•_-• -~._..- ~.__ 4_...................... 3 • • 104TH CONGRESS: APPROPRIATIONS ----..__....--- [9] House Votes to Remove Riders from EPA Funding Bill ..... ............. .................................. __3 HRAE - - [10] Ventilation Standard Discussed During IAQConference; Committee Chairman Proposes _ Acceptable IAQ Definition ............. ........--•---.--______..__............~----._.._---__..____ ................_.3 - [11] Correction Made Regarding European Prestandard on Ventilation ........................ ••......... w_.4 AMERICAN SOCIETY FOR TESTING AND MATERIALS (ASTM) [12] ASTM Developing Evaluative IAQ Standards ............. ............ __».___._-_._................................ 4 OFFICE OF TECHNOLOGY ASSESSMENT (OTA) ----- [13] OTA Releases Report on Health Risks in Nation's Schools ............. •.... ........ -.......................... 4__ - STATE AND LOCAL GOVERNMENTS -- REGION 1- NORTHEAST - MA, ME, NH, RI, VT [14] Massachusetts IAQBills Proceed through Committee ..................... .................................. •-•=-•5 - - - - - [15] Sharon, Massachusetts, to Keep Outdoor Smoking Ban ....................................................•.•••• 5 REGION 2 - NEW YORK/CONNECTICUT - NY, CT [16] Third Nassau Public Hearing on Proposed Smoking Ordinance .......... •........ .-_ ..............._.~._ REGION 3 - CHESAPEAKE - DC, DE, MD, NJ, PA __ [17] Pennsylvania Smoking Ban Introduced .................... •................. •_.......................................... 6 REGION 7 - NORTH CENTRAL - LA, IL, MN, tWT [18] Smoking Restrictions Expand in Illinois Capitol .......................... ............................... __•__-6_ REGION 9 - TEXASILOUISIANA - LA, TX -- [19] Black Market Cigarettes Exchanged in Texas Prisons ...... ................... ................. ____. ..- ~ 6 REGION 11 - CALIFORNIAIHAWAII - CA, HI [20] Palo Alto's Outdoor Smoking Law Takes Effect .......... ............................... ................. ._.......... 6 ETS-RELATED LITIGATION BROUGHT BY CIGARETTE MANUFACTURERS [21] EPA Risk Assessment Litigation: EPA Seeks Protective Order .................•...._-_-. ............ -•__.___._. 7 ETS-RELATED LITIGATION AGAINST CIGARETTE MANUFACTURERS [22] Broin: Plaintiffs File Appeal Brief ............................... ........... »......................................... ri..... 7 - ETSIIAQ LITIGATION NOT INVOLVING CIGARETTE MANUFACTURERS _ WORKPLACE: DISABILITY DISCRIMINATION _ ._.~.. . [23] Petta v. Department ofthe Interior, 1995 WL 590554 (Equal Employment Opportunity Commission) (decided September 25, 1995) .......................... _... .............._ 7 - ~' - WORKPLACE: COLLECTIVE BARGAINING _ O [24] Department of the Treasury, Internal Revenue Service, Fresno, Callfornia and Chapter 97, ~ National Treasury Employees Union, 1995 WL 618900 (Federal Service Impasses Panel) (decided October 12, 1995) ._• ................••__•.-.----_._._._,.,...__.••..._...___ 8 f..1 [25] Department ofthe Army, Fort Drum, New York and Local R2-61, National Association of F~+ GovernrnentEmployees, SEIU, AFL-CIO, 1995 WL 576783 (Federal Service Impasses Panel) ~ (decided September 27, 1995) .............................. •..•...•...... ___. ................ --...... _...._.... ____-... 8 ~ ~ ~
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• Contents Continued, Issue 110 [26] Department ofthe Air Force, Eielson Air Force Base, Aloska, and Local 1836, American Federation ofGovernmentEmployees, AFL-CIO, 1995 WL 576797 (Federal Service Impasses Panel) (decided September 27, 1995) ...................................................................................... 8 WORKPLACE: HOSTILE WORK ENVIRONMENT . -- [27] Dillard v. Department oftheArrny, 1995 WL 548427 (Equal Employment Opporruniry Commission) (decided September 8, 1995) ......................... ..........-............. ............................ 8 WORKPLACE: UNFAIR LABOR PRACTICES [28] Imperial Floral Distributors, Inc. and Arnalgavnated Irulustrial and Toy and Novelty Workers ofAmerica, Local223, 1995 WL 592490 (National Labor Relations Board) (decided September 29, 1995) .......................................... ...............................................-.....::: 9 PRISONER CASE . - .... .. _ . .. . . _'-_` [29] Peeples v. Department ofCorrections, 1995 WL 600520 (Ohio Court of Appeals) (decided October 12, 1995) ................................. ............ •...................................................... 9 LEGAL ISSUES AND DEVELOPMENTS [30] "Air Quality Awareness Leads to Building Cleanup Efforts," R. Banham, Journal of Commerce, October 6, 1995 .......... ............................. ..........------------- ...._ ------ ........ .................. 9 OTHER DEVELOPMENTS [31] Revision Committee Member to Co-direct New Policy Inscicute ..... ......_ ..... ............_...~__.2_ [32] Multiple Chemical Sensitivity Symposium Agenda Ignites Controversy ................................ 10 [33] Smoking Ban Suspended for Peace Negotiations ................................................................... 10 [34] Smoking Provides Opportunity for Peaceful Exchange .......................... _.............................. 10 [357 U.S. Hotels Increase Number of Nonsmoking Rooms .......................................................... 10 SCIENTIFIC/TECHNICAL ITEMS • • UPCOMING SCIENTIFIC MEETINGS : = [36] "Advances in Medical Surveillance for Environmental and Occupational Health: From Exposure Onset through Health Outcome," Bethesda, Maryland, December 6-8, 1995 ....... 11 [37] 1996 ASHRAE Winter Meeting, Atlanta, Georgia, February 17-21, 1996 ............................ 11 [38] Society ofToxicology 35th Annual Meeting, Anaheim, California, March 10-14, 1996 ....... 11 [39] "IAQ'96: Paths to Better Building Environments," Baltimore, Maryland, October 6-8, 1996..... 11 LUNG CANCER [40] "Uncertainties in Lung Cancer Risk Estimates Reported for Exposure to Environmental Tobacco Smoke," A.J. Gross, Environmetrics 6: 403-412, 1995 [See Appendix B] ................. 11 [41] "Environmental Tobacco Smoke and Lung Cancer: Uncertainties in the Population Estimates But Not in the Causal Association - A Rejoinder to Gross," S. Bayard, J. Jinot, and G. Flatman, Environrnetrics 6: 413-41 8, 1995 [See Appendix B] ....................... 11 [42] "Uncertainties in Lung Cancer Risk Estimates Reported for Exposure to Environmental Tobacco Smoke - A Rejoinder to Gross," J.A. Hanley, Environmetrics 6: 419-422, 1995 11 [See Appendix B] ........................... ........... ................... ..._._. _._.~...~_ . [43] "Uncertainties in Lung Cancer Risk Estimates Reported for Exposure to Environmental Tobacco Smoke Revisited- A Response to BayardlJinot/Flatman and Hanley," A.J. Gross, Environrnetrics 6: 423-424, 1995 [See Appendix B] ............................................................... 12 CARDIOVASCULAR ISSUES [44] "Risk Factor Profile of Nonsmokers with Peripheral Arterial Disease," F.G.R. Fowkes, J.T. Dunbar, and A.J. Lee, Angiology 46: 657-662, 1995 [See Appendix B] ........................... 12 [45] Letters to the Editor Regarding "Inhalation ofSidestream Cigarette Smoke Accelerates -- Development of Arteriosclerotic Plaques," A. Penn and C.A. Snyder, Circulation 88: 1820-1825, 1993 .............................................. .------- _.------ ...:12 RESPIRATORY DISEASES AND CONDITIONS - CHILDREN - [46] "Socioeconomic Status and Indicators ofAsthma in Children," P. Ernst, K_. De_rnissie, L. Joseph, U. Locher, and M.R. Becklake, American Journal ofResairatory and Critical- __ Care Medicine 152: 570-575, 1995 [See Appendix BI ........................................................... 12 REPRODUCTIVE AND DEVELOPMENTAL ISSUES [47] "SIDS Epidemiology and Incidence," T. Dwyer and A.L. Ponsonby, Pediatric Annals 24: 350-356, 1995 [See Appendix B] .............................. ........ ................... ................ ........... 13 [48] "Functional and Developmental Studies of the Peripheral Arterial Chemoreceprors in Rat: Effects of Nicotine and Possible Relation to Sudden Infant Death Syndrome," H. Holgert, T. Hokfelt, T. Hertzberg, and H. Lagercranrz, Proceedings of the National Academy of Sciences USA 92: 7575-7579, 1995 [See Appendix B] ....................................... 13 - -
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• • • Contents Continued, Issue I10 OTHER HEALTH ISSUES [49] "Risk Factors for a First Febrile Seizure: A Matched Case-Control Study," A.T. Berg, [50] S. Shinnar, E.D. Shapiro, M.E. Salomon, E.F. Crain, and W.A. Hauser, Epilepsia 36: 334-341, 1995 [See Appendix B] ........................................................ ............................... .._ 13 "Relation Between Passive Tobacco Smoke Exposure and the Development of Bacterial Menin- gitis in Children," R.C. Bredfeldt, S.R. Cain, G.E. Schutze, T.M. Hofines, and-L.A. McGhee,_ -_ __ journal ofthe American Board ofFarnily Practice 8: 95-98, 1995 [See Appendix B] .. 13 [51] "Involuntary Smoking and Children's Health," J.M. Samet, E.M. Lewit, and K.E. Warner, CurrentProblems in Pediatrics 25{6}: 189-204, 1995 [See Appendix B] ................................. 13 ETS EXPOSURE AND MONITORING [52] "Are Self-Reports of Smoking Rate Biased? Evidence from the Second National Health and Nutrition Examination Survey," R.C. Klesges, M. Debon, and J.W. Ray, journal ofClinical Eprdemiologv 48: 1225-1233, 1995 [See Appendix B] ......................................... _ 13 GENOTOXICITY AND MUTAGENICITY [53] "Genetic-Environmental Interactions and Low-Level Exposure to Carcinogens," P. Vineis and T. Martone, Epidemiology 6: 455-457, 1995 [See Appendix B] ....................................... 14 INDOOR AIR QUALITY [54] "Possible Mechanisms For the Respiratory Tract Effects of Noncarcinogenic Indoor- Climate Pollutants and Bases for Their Risk Assessment," G.D. Nielsen, Y. Ala.rie, O.M. Poulsen, and B.A. Nexo, Scandinavian Journal of Work and Environmental Health 21: 165-178, 1995 [See Appendix B] .................... ........................ .............................. _........ 14 [55] "Air Nicotine and Saliva Cocinine as Indicators of Workplace Passive Smoking Exposure and Risk," J.L. Repace, J. Jinoc, and S. Bayard, manuscript submitted for publication, available to the public as Exhibit 340-1753 in OSHA Docket H-122 [See Appendix B] ....... 14 STATISTICS AND RISK ASSESSMENT [56] "Heterogeneity in Meta-Analysis of Data From Epidemiologic Studies: A Commentary," G.A. Colditz, E. Burdick, and F. Mosteller, American Journal ofBpidemiology, 142: 371-382, 1995 [See Appendix B] ....................................... ................................................ _. 14 [57] "Invited Commentary: Benefits of Heterogeneiry in Meta-Analysis of Data From Epidemi- ologic Studies," J.A. Berlin, American journal ofEpidnniology 142: 383-387, 1995 [See Appendix B] ..................._.......................... ............................ -14 IN EUROPE & AROUND THE WORLD REGULATORY AND LEGISLATIVE MATTERS ARGENTINA [58] Rosario Adopts Restaurant Smoking Ordinance .......................... ...................................... ..-. 15 BRAZIL [59] Souza Cruz Launches Freedom of Choice Campaign ............................................................ 15 - [60] Sao Paulo Governor to Approve Restaurant Smoking Restriction .......................................... 15 EUROPEAN UNION [61] Parliament Calls for Antismoking Measures ....... ............................ ...._............... ........... ...__.-. 15 OTHER DEVELOPMENTS AuSTRALIA [62] WA Health Department Launches Health Information Campaign :..:.............::...::......._... 15 EUROPEAN UNION . . ~__~. 16 [63] Philip Morris Sponsors New European Ad Campaign ................ ............. ....................... GREECE - . .....-. . __- ` [64] International Trade Group Adopts Risk Assessment Principles .............................................. 16 NETHERLANDS [65] Uncertain Economic Impact ofKLM Smoking Restrictions .................... ........................ .___.,_ 16 UNITED KINGDOM 1~ [66] Smoking Restrictions Imposed on Chartered Airline Flights ................. . ........ ............ ____16 - Q [67] Smoking Encounter at "Faulty Towers" ................... .......... ............... .,....... __. L6-__ UNITED NATIONS [68] Headquarters Adopts Smoking Restrictions ........................................................................... 17_= APPENDIXA ........................................ ..................... --°.... -........ -----__-. -_.-_..__..-_Regulatory Reform Legislation APPENDIX B ................................... -•-•---........------- ---------- ----.....---...-----.....__ - Article Summaries APPENDIX C .................................................................................................... ....Upcoming Scientific Meetings APPENDIX D .................................................................................................... .............. List of I-I.R. 2099 Conferees ~ ~ ~ ~
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• • • NOVFMBER 3, 1995 REPORT ON RECENT ETS AND IAQ DEVELOPMENTS IN THE UNITED STATES REGULATORY AND LEGISLATIVE MATTERS OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA) [1] Deadline for Second Phase of Post-Hearing Comments Extended By order dated October 23, 1995, the administrative judge presiding over OSHA's rulemaking on indoor air and indoor smoking extended the deadline for the submission of post-hearing briefs from November 13, 1995, until January 16, 1996. Motions for extension had been submitted by Philip Morris, R.J. Reynolds, ChemRisk, The Tobacco Institute, the Chelsea Group, Limited, and the Hotel Employees and Restaurant Employees International Union. OSHA had agreed to a 41-day extension in "recogni- tion of some confusion regarding the workings of the docket office," but Judge John Vittone noted in his order that an extension of 41 days would "put the deadline in the middle of the holidays at the end of December, which would be an inconvenient time for the filing of a large number of documents." Accord- ingly, he extended the deadline to mid-January. [2] OTA Concludes OSHA's Cost Analyses May Be Overestimated According to a study conducted at the request of Congress by the Office of Technology Assessment (OTA), OSHA's system for analyzing the costs of its regulations has worked well and in some instances may have actually overestimated difficulty and cost to employers. It is unknown what impact this study will have, if any, on the estimated costs associated with OSHA's proposed rule on indoor air quality. The study, released on October 24, 1995, examined five health standards and three safety standards pro- mulgated by OSHA between 1974_an_d 1989. Case study comparisons reportedly concluded that the agency's regulatory analyses "have reasonably grasped many of the essential features of the affected indus- tries." Overestimates of cost were apparently the result of OSHA's failure to account for innovations spurred by technological improvements or the regulation itself. The study, titled Gauging Control Technology and Regulatory Impact in Occupational Safety and Health - An Appraisal of OSHA's Ana ytic Approach, criticized OSHA for devoting little attention to the possibility that employees can be protected from workplace risks with lower costs to industry through technological innovations. Evidently, the agency has preferred conventional methods of controlling hazards. Accord- ing to OTA, "this is a substantive deficit that particularly deserves OSHA's consideration" and the attention of Congress. See Occupational Safety 6' Health Reporter, October 25, 1995. [3] Stakeholders Consider Proposed Safety and Health Standard OSHA reportedly conducted a meeting October 16- 17, 1995, to involve stakeholders in the development of a workplace safety and health standard, which would, among other matters, require employers to identify and control all worksite hazards as part of an overall safety and health plan. OSHA's proposed rule on indoor air quality is not specifically referred to in the proposal, which simply calls for control or elimina- tion of workplace "hazards within a reasonable time." According to a press report, most of the 50 stakeholders attending the meeting already have such plans in place, thus, they did not disagree with the proposal as outlined during the meeting. Small business owners did not participate, but their representatives are reportedly warning that they will oppose any OSHA standard of this nature. See Inside OSHA, October 23, 1995. SHB
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2 [4] Senate Task Force Seeks Regulatory Reform through OSHA Reform Legislation The Senate Task Force on Regulatory Relief, chaired by Senators Kit Bond (R-Mo.) and Kay Bailey Hutchison (R-Tex.), has reportedly made a number of OSHA reform recommendations to the chairwoman of the Committee on Labor and Human Resources. In a letter dated October 17, 1995, to Senator Nancy Kassebaum (R-Kan.), the Task Force declares that its priority is "easing the burden of federal regulation." To that end, the Task Force states it is "hopeful that [Senator Dole's regulatory reform bill] S. 343 will become law so that all federal agencies will be required to consider the magnitude of the risks they are regulat- ing and the resulting costs and benefits. In the event that S. 343 has not passed by the time the Labor Committee marks up OSHA reform legislation, the Task Force hopes risk assessment and cost benefit provisions will be part of your OSHA reform bill." See Inside OSHA, October 23, 1995. ENVIRONMENTAL PROTECTION AGENCY (EPA) [5] Browner Mandates Consideration of Risks to Children According to a press report, EPA Administrator Carol Browner circulated a memorandum to senior agency managers on October 20, 1995, setting forth a new EPA policy that will require the agency to "con- sider the risks to infants and children consistently and explicitly as part of risk assessments generated during its decision making process, including the setting of standards to protect the public health and the environ- ment." The new policy will require the agency to "develop a separate assessment of risks to infants and children or state clearly why this is not done." The policy will apparently apply to those assessments commenced or revised on or after November 1, 1995. EPA staffers have reportedly indicated that risks to children have generally been considered by the agency and that the new policy should not change agency initiatives unless effects of particular hazards on children differ significantly from effects on adults. See Inside EPA, October 27, 1995. ETS/IAQ REPORT, ISSUE 110 [6] Government Officials Discuss Regulatory Reform at Risk Assessment Conference Speakers at a recent conference on risk assessment discussed regulatory reform initiatives currently pending in Congress. The conference, RiskAssessrnent 1995: Where Does the Great Risk Debate Stand Now ; was held October 17-18, 1995, in Arlington, Virginia, and was sponsored by Inside EPA. Congressional staffers supportive of regulatory reform criticized EPA for refusing to accept that overstating risks is not the way to address such issues and suggested that legisla- tion pending in Congress would force federal officials to treat risks fairly and not exaggerate them. A White House staffer reportedly argued that current legislative proposals "are too broad and prescriptive" and impose analyses that may not be needed. Accord- ing to this staffer, the Clinton administration favors a statute-by-statute fix to the problem and is committed to pollution prevention, in the belief that "zero expo- sure" will make risk assessment unnecessary and will save time and money. A panel discussion on EPA's dioxin reassessment reportedly involved EPA's William Farland, who indicated that the agency's Science Advisory Board (SAB) will peer review chapters eight and nine in June 1996, and that a revised, SAB-endorsed document will likely be released in September 1996. The draft review of the dioxin reassessment, released on September 8, 1995, identified smoking as a "potential exposure pathway" for dioxin and recommended that EPA "consider possible contributions to exposure from environmental tobacco smoke." Further details about the dioxin reassessment appear in issue 107 of this Report, September 22, 1995. Speakers commenting on the regulatory reform debate in the Senate apparently agreed that political polarization destroyed efforts to achieve moderate, middle-ground reforms. A conference participant reportedly disagreed with a statement about industry attorneys providing a briefing to Senate Judiciary staffers and writing reform legislation. Speaker Tom Roberts, formerly with EPA's congressional office, responded by noting that industry, federal agencies, environmentalists, and other interested parties rou- tinely assist in the drafting of legislation and the practice should not be regarded as "new or evil." See Risk Policy Report, October 20, 1995. SHB
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NOVLMBER 3, 1995 • • [7] New VOC Sampling Method Offers Increased Accuracy Scientists in the EPA's Office of Research and Development have reportedly developed an instrument that allows analysis of volatile organic compound (VOC) exposure in a single human breath. A recent press report indicates that the single-breath canister method of measuring VOC exposure utilizes a one-liter stainless steel canister that collects a single breath, which can later be analyzed using gas chromatography- mass spectrometry. Apparently, investigators will use carbon dioxide, isoprene and acetone concentrations to determine that the breath captured is alveolar breath, breath from the sections of the lungs where gas exchange takes place. EPA scientists claim that the canister method is superior to other methods of VOC testing in indoor environments because it will indicate actual personal exposure to individual compounds instead of indicat- ing a variety of chemicals in the ambient air. The method is expected to be particularly useful in cases where building owners or managers refuse IAQ investigations; an individual could use the canister while in the building and the resulting breath analysis could be compared to baseline measurements taken before the individual entered the building. See Indoor Air Quality Update, October 1995. 104TH CONGRESS: REGULATORY REFORM [8] House Committee Approves Sunset Legislation; New Regulatory Reform Measures Introduced in Senate On October 31, 1995, the House Judiciary Commit- tee approved the Regulatory Sunset and Review Act of 1995 (H.R. 994), which would require periodic review of existing significant federal regulations. The measure would provide for the modification, consolidation or termination of any regulation found to be obsolete, unnecessary, duplicative, or in conflict with the purpose of the underlying statute. The bill was previ- ously marked up by another House committee on July 18, and reported out with an amendment in the nature of a substitute. Senator Spencer Abraham (R) introduced the "Regula- tory Review Act of 1995" (S. 1346), and Wisconsin Senator Russell Feingold, Jr. (D), introduced the "Small Business Fair Treatment Act of 1995" (S. 1350). Both bills were referred to the Committee on Governmental Affairs. The Abraham bill would require the periodic review of federal regulations and would permit public petitions and Congressional requests for such review. The bill also establishes criteria and procedures for sunset review. The Feingold proposal would require federal agencies to prepare compliance guides for small businesses and would prohibit enforcement actions on the basis of rules for which no compliance guides have been developed. The proposal also permits small businesses to seek "no action" letters which would further limit enforcement of federal regulations. No hearings have yet been scheduled on either bill. See CQ FaxReport, October 31, 1995. Current activities on all of the regulatory reform bills introduced during this session of Congress can be found in Appendix A. 104TH CONGRESS: APPROPRIATIONS [9] House Votes to Remove Riders from EPA -- - - Funding Bill On November 2, 1995, the House reportedly voted 227-194 to instruct House conferees to remove EPA enforcement limitations from the House-approved version of the EPA appropriations bill (H.R. 2099). The nonbinding instructions will, if followed in conference, result in the removal of 17 "riders" placed in the bill by House Republicans who argued the riders were necessary to curb agency abuses. The Senate has no riders in its version of the appropriations bill and is apparently unwilling to accept them. See CQ FaxReport, November 2, 1995. ASHRAE [10] Ventilation Standard Discussed During LAQ Conference; Committee Chairman Proposes ~ ~ Acceptable IAQ Definition r~+ Meanwhile, on October 20, two regulatory reform During ASHRAE's LAQ'95 conference in Denver, measures were introduced in the Senate. Michigan • the chairman of the committee that is revising Stan- SHB
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4 dard 62-1989 on ventilation began his discussion of the current revision draft by proposing a new defini- tion of acceptable indoor air quality. Chairman Steve Taylor's proposal would remove the "negligible risk" language from the current draft definition, which language converts the ventilation standard into a guarantee of health. In outlining the new sections of the current draft, Taylor noted that philosophical changes from Standard 62-1989 include an assumption for establishing ventilation rates that no smoking will occur in indoor spaces. The October 22-24, 1995, conference also featured a workshop on methods of removing ETS from indoor environments. Participating in the discussion were representatives of various industries who addressed filtration and ventilation issues. A legionella workshop was led by a former CDC employee, who claimed that legionella claims 7,000 to 8,000 lives per year in this country, making it the most deadly indoor air problem. The figure was calculated by applying the percentage of deaths from Legionnaires' disease to an average of the disease incidence reported by CDC. Attorneys who discussed liability issues suggested that if Standard 62-1989 becomes a health standard during the revision process, IAQplaintiffs will win more cases. According to plaintiffs' attorney Mark Diamond, plaintiffs will use the standard that emerges from the committee process, prior to public review, as "state of the art" to hold defendants liable for IAQ related injuries. Taylor has circulated his proposed definition of acceptable indoor air quality to members of the committee revising Standard 62-1989. In his accompa- nying comments, Taylor notes that reference to and interpretation of "cognizant authorities" in the defini- tion have "important implications." Tay or also supports his proposal by noting that the ventilation rates prescribed in the current draft are based on perception and "engineering judgment" rather than health. [11] Correction Made Regarding European Prestandard on Ventilation It was previously reported that a member of the committee revising ASHRAE's standard on ventilation was the contact for information regarding a "ventila- tion prestandard" adopted by European countries ETS/IAQ REPORT, ISSUE 1 10 earlier this year. According to a correction appearing in the publication on which this information was based, the prestandard (prENV 1752) was actually rejected "because of its possible legal consequences" and because "it is still not possible to measure indoor air quality and most emissions of building materials." The prestandard is, however, apparently being considered for publication as a technical report. See IndoorAir Qirality Upd~rte, October 1995. AMERICAN SOCIETY FOR TESTING AND MATERIALS (ASTM) [12] ASTM Developing Evaluative IAQStandards According to a press report, ASTM is currently developing standards related to the evaluation and control of indoor air risks. The standards under consideration include criteria for evaluating environ- mental remediation contractors and environmental consultants and cover environmental areas such as IAQ, PCBs, radon, asbestos, lead, and underground storage tanks. ASTM has reportedly said the standards should help insurers and others evaluate such profes- sionals in a uniform manner. See Indoor Pollution News, October 30, 1995. OFFICE OF TECHNOLOGY ASSESSMENT ~QTA~ [13] OTA Releases Report on Health Risks in Nation's Schools A recent report by the U.S. Office of Technology Assessment concludes that health risks encountered by American children in schools are no greater than those found in other large buildings. According to a press report, "Risks to Students in Schools" attributes most IAQ problems in schools to "inadequately designed or maintained HVAC systems." Other factors attributed to poor IAQ in the report include art and science materials, teacher or student smoking areas, and exhaust fumes from buses. The report also notes difficulty in collecting significant data about environmental hazards such as radon, asbestos and electro-magnetic fields because student exposure levels have seldom been measured. Claim- ing that asbestos and radon are probably the most studied school pollutants, the report asserts that SHB •
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• • • NOVEMBER 3, 1995 "other pollutants of concern" include ETS, volatile organic compounds, combustion by-products and biological organisms. See Indoor Pollution News, October 30, 1995. Earlier this year, the U.S. General Accounting Office (GAO) reported that 15.5 million students in more than 28,000 schools are affected by less-than-adequate heating, ventilation and air conditioning. The GAO concluded that $112 billion would be needed to repair or upgrade America's schools to good overall condi- tion. For additional information concerning the GAO study, see issue 91 of this Report, February 17, 1995. Also, a biologist recently published a book titled IndoorAir Quality in Schools, which discusses a number of IAQ problems encountered in U.S. schools. See issue 104 of this Report, August 25, 1995. STATE AND LOCAL GOVERNMENTS REGION 1 - NORTHEAST - MA,ME,NH,RI,VT [14] Massachusetts IAQBills Proceed through Committee House Bills 838 and 839, which would create minimum ventilation standards for newly constructed state buildings or state-leased buildings, have moved from the House Committee on Ways and Means to the Committee on the Third Reading. H.B. 838 would mandate ventilation rates in conformance with cfm rates in Table 2 of ASHRAE Standard 62-1989, with schools and office buildings required to maintain a rate of no less than 10 cfm per person. In most cases, mechanical ventilation systems would have to operate continuously during normal business hours. The bill would also require annual, documented HVAC inspections, with violators subject to a$1,000 fine and imprisonment. H.B. 839 would empower the Department of Labor and Industries to enforce ventilation codes in all state buildings according to a plan to be developed within 18 months. The department would have to develop rules and guidelines for implementing the law within 5 nine months of enactment. The bill would provide penalties identical to those in H.B. 838. [15] Sharon, Massachusetts, to Keep Outdoor Smoking Ban By a vote of 670 to 470, residents of Sharon decided on October 30, 1995, to retain one of the most stringent outdoor smoking ordinances in the nation, according to a press report. The vote was reportedly prompted by hundreds of signatures on a petition calling for a second vote. The Sharon ordinance, in effect since June 1995, is described as the first of its kind in Massachusetts. It prohibits smoking at the town's playgrounds, beaches and ballfields. Dana Bottorff, a public relations consultant who led the drive for the law, reportedly stated, "[a] lot of people who were probably on the fence about [the ban] in May saw a successful summer i at the beaches, playgrounds and fields." See The Boston Globe, October 31, 1995. REGION 2 -INEW Y-O_RK_ICONNECT_I-CUT - _ NY, CT - - - - ---- - [16] Third Nassau Public Hearing on Proposed Smoking Ordinance A press report indicates that one Nassau County restaurant owner recently compared his options under a proposed public smoking ordi- nance to an electric chair or a firing squad. The comment was apparently made at a public hearing attended by approximately 125 people on October 18, 1995, on a proposed county ordinance that would prohibit smoking in restaurants. The ordinance would also apparently prohibit smoking in bowling alleys until 5:00 p.m., and would require workplaces, stores and sports arenas that allow smoking to establish separately ventilated areas. Bars deriving less than 40 percent of their revenue from food sales would report- edly be exempt from smoking restrictions. Two earlier hearings apparently considered another proposal that would have allowed separately ventilated smoking areas in restaurants and bars; however, complaints were received concerning cost and space limitations. Opponents of the new proposal reportedly SHB
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6 contend that it is extreme and would drive away 20-30 percent of existing business. Proponents counter that the ordinance would level the playing field for small and large establishments, and that analyses of sales tax data from other cities indicate smoking bans have "no significant effect on business." Apparently, both proposals are still under consideration. See Newsday, October 19, 1995. REGION 3 - CHESAPEAKE - DC, DE, MD, NJ, PA [17] Pennsylvania Smoking Ban Introduced ,;p ~ _ _ Pennsylvania House Bill 2085, ~ ~ introduced and sent to the House Committee on Commerce and Economic Development in October 1995, would repeal 1988 amendments to the Fire and Panic Act and replace them with a public and work- place smoking ban. The bill would prohibit smoking in (i) public places owned or operated by state or local governments; (ii) workplaces; (iii) educational and health facilities; (iv) auditoriums, arenas and theatres; (v) restaurants and bars; (vi) concert halls; (vii) hotels and motels; and (viii) open-air stadiums, theatres, and similar facilities. The law would take effect 60 days after its passage. The current public smoking law in Pennsylvania requires employers to have written smoking policies and prohibits smoking in designated nonsmoking areas. It exempts a number of facilities from its provi- sions, including bars and restaurants seating fewer than 75 persons. REGION 7 - NORTH CENTRAL - IA IL, MN, WI [18] Smoking Restrictions Expand in Illinois Capitol ~ House Speaker Lee A. Daniels (R- Elmhurst) ' ~ Flmhurst) has reportedly prohibited smoking in one of the last and ~~ largest smoking areas of the Illinois state capital. Apparently, the new rule covers a windowed corridor on the east side of the House chamber used by lawmakers, lobbyists, staff members, and the media to view the House floor. ETS/IAQ REPORT, ISSUE 110 Spokesman Mike Cys cited odor and frequent carpet, curtain and furniture cleaning as the reasons for the rule, according to press reports. Although the Senate still allows smoking, smoking is reportedly already prohibited in the House chambers and galleries. See Chicago Sun-Tirnes, October 20, 1995. LA, TX [19] Black Market Cigarettes Exchanged in Texas Prisons According to press reports, a 7- month-old Texas prison smoking ban has created a lucrative black market for tobacco, with smuggled cigarettes selling for as much as $100 per pack. Patrick O'Shaughnessy of the Texas Department of Criminal Justice reportedly stated that "tobacco has replaced marijuana as the substance that causes officers to take bribes." Tobacco-related cases against seven guards have apparently been referred to prosecutors, with 55 administrative investigations having been conducted since March 1, 1995. Apparently, good ventilation systems, surveillance blind spots and inmate lookouts provide ample opportunity for inmate smoking. Smuggled, roll- your-own tobacco has reportedly been found in inmates' underwear, waist bands, shoe soles, work- places, and cells. Punishment for inmates caught with tobacco may include lost privileges, solitary confine- ment and loss of good-conduct credits. See The Houston Chronicle, October 28, 1995; St. Louis Post- Dispatch, October 29, 1995. REGION 9 - TF_-,,As/Lou1slA~rA - IZ.EGION 1 I - CAL.IFORNWHAWAII - CA, H I [20] Palo Alto's Outdoor Smoking Law Takes Effect October 27, 1995. Press reports indicate that police will refrain from enforcing the law for several weeks, intending to limit their activities to responding to citizen complaints. Warnings will reportedly be issued A doorway smoking ban in Palo Alto reportedly took effect on • • SHB
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• • • NOVEMBER 3, 1995 to first-time offenders; however, a third violation of the law is punishable by a fine ranging from $100 to $300. The outdoor smoking ordinance apparently prohib- its smoking within 20 feet of the doorway to a business or other building to which the public has access. The law also reportedly prohibits smoking within 20 feet of bleachers, backstops and other park recreational equipment. Apparently, the law exempts employee-only doorways and does not apply between 10 p.m. and 6 a.m. Press reports also indicate that smoking pedestrians may pass within 20 feet of doorways under the ordinance. See United Press Internationa4 October 27, 1995; The San Francisco Chronicle, October 28, 1995. ETS-RELATED LITIGATION BROUGHT BY CIGARETTE MANUFACTURERS [21] EPA Risk Assessment Litigation: EPA Seeks Protective Order EPA moved for a protective order on October 20, 1995, attempting to forestall discovery by plaintiffs. In their discovery requests, plaintiffs sought additional information concerning EPA's purported authority to conduct the Risk Assessment on ETS. Plaintiffs have not yet responded to the motion. In June 1993, six tobacco-related plaintiffs sued EPA, seeking a declaration that the agency's Group A designation of ETS and the underlying risk assessment are null and void. Plaintiffs also seek an injunction requiring EPA to withdraw both the designation and risk assessment. Plaintiffs include the Flue-Cured Tobacco Cooperative Stabilization Corporation; The Council for Burley Tobacco, Inc.; Universal Leaf Tobacco Company, Inc.; Philip Morris, Inc.; R.J. Reynolds Tobacco Company; and Gallins Vending Company. Flue-Cured Tobacco Cooperative Stabiliza- tion Corporation, et al. v. EPA, No. 6:93CV370 (U.S. District Court, Middle District, North Carolina) (filed June 22, 1993). ETS-RELATED LITIGATION AGAINST CIGARETTE MANUFACTURERS attendants. [22] Broin: Plaintiffs File Appeal Brief On October 26, 1995, plaintiffs filed their brief in opposition to defendants' appeal of the trial court's December 1994 class certification order. Defendants are scheduled to file their reply brief on November 15. The Court of Appeal has not scheduled argument. At issue in this case are the claims of flight attendants allegedly 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 Injuries alleged by the putative class representatives include lung cancer, breast cancer and various respira- tory 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 the six major U.S. cigarette manufacturers (plus entities related to some of the manufacturers), United States Tobacco Company, Dosal Tobacco Corp., the Council for Tobacco Re- search, The Tobacco Institute, and three trade associations. Broin, et al. V. Philip Morris, et al. (Circuit Court, Dade County, Florida) (filed October 31, 1991). LVING _ ETS/IAQ LITIGATION NOT INVOLVING CIGARETTE MANUFACTURERS _ _ WORKPLACE: DISABILITY DISCRIMINATION [23] Petta v. Department of the Interior, 1995 WL 590554 (Equal Employment Opportunity Commission) (decided September 25, 1995) The Equal Employment Opportunity Commission rejected claimant's allegation that the U.S. Department of Interior discriminated against her due to an "allergic reaction" to ETS. Statements_from claimant's doctors failed to prove that her reaction to ETS constituted a disability under commission regulations, the commis- sion found. The commission observed that "the focus is not merely on whether the individual has a physi- ological disorder or condition, but rather on whether SHB
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8 she has been classified (correctly or incorrectly) as having an impairment that substantially limits one or more of her major life activities." A General Services Administration air quality study of the building found no significant problems. WORKPLACE: COLLECTIVE BARGAINING [24] Department of the Treasury, Internal Revenue Service, Fresno, California and Chapter 97, National Treasury Employees Union, 1995 WL 618900 (Federal Service Impasses Panel) (decided October 12, 1995) A Federal Service Impasses Panel resolved a workplace smoking impasse between the Internal Revenue Service's Fresno Service Center and an employees' union by adopting the employer's proposal to prohibit indoor smoking. The union had proposed maintaining existing designated indoor smoking areas. The union represents approximately 6,000 IRS employees at the Fresno center. The panel found that the IRS would need to spend more than $1 million to modify existing smoking areas to comply with ventilation standards for federal buildings. The IRS had already covered several outdoor atriums designated as smoking areas prior to unsuccess- ful mediation in September 1995. The panel cited the EPA Risk Assessment on ETS in concluding that "the dangers associated with exposure to second-hand smoke have been well documented." [25] Department of the Army, Fort Drum, New York and Local R2-61, National Association of Gov- ernment Employees, SEIU, AFL-CIO, 1995 WL 576783 (Federal Service Impasses Panel) (decided September 27, 1995) A Federal Service Impasses Panel resolved a smoking policy dispute between the U.S. Army at Fort Drum, New York, and three employees' unions by adopting a policy prohibiting indoor smoking in all buildings except soldiers' clubs, two snack bars, the bowling center and living quarters. The policy is similar to one the panel previously adopted for Malmstrom Air Force Base. The panel rejected the unions' proposed modifi- cation to that policy that would have allowed indoor smoking when temperatures drop below 35 degrees ETSIIAQ REPORT, ISSUE 110 Fahrenheit, a common occurrence in Watertown, New York, where Fort Drum is located. The unions also argued that Fort Drum, unlike Malmstrom, is an "open" facility, which increases the potential for "injury or foul play" by persons from outside the base when smokers are forced outside late at night. [26] Department of the Air Force, Eielson Air Force Base, Alaska, and Local 1836, American Federa- - tion of Government Employees, AFL-CIO, 1995 WL 576797 (Federal Service Impasses Panel) (decided September 27, 1995) Citing the EPA Risk Assessment on ETS, a Federal Service Impasses Panel imposed an indoor smoking ban at Eielson Air Force Base, Alaska, notwithstanding a union's concern that outdoor smoking could lead to "frostbite, hypothermia, and other hazards" associated with extreme cold. The union, which represents approximately 300 employees, sought to preserve existing indoor smoking areas, while agreeing that designated smoking areas in new buildings would meet all pertinent ventilation standards. The panel's order requires the parties to submit to grievance arbitration should they fail to agree on the design characteristics of outdoor smoking shelters. WORKPLACE: HOSTILE WORK ENVIRONMENT [27] Dillard v. Department of the Army, 1995 WL 548427 (Equal Employment Opportunity Commission) (decided September 8, 1995) The Equal Employment Opportunity Commission ruled that smoking by claimant's co-workers could not be attributed to their employer, rejecting claimant's charge that the smoking activity was part of a compre- hensive "hostile and intimidating" work environment. Claimant's co-workers allegedly smoked outside an open door near claimant's work station and failed to close the door pursuant to claimant's request. Claimant attempted to link allegations of continuing "hostile" smoking by co-workers with prior claims against her supervisor to satisfy a 45-day requirement that claim- ants contact an Equal Employment Opportunity counselor within 45 days after an alleged violation of Commission regulations. Because co-worker smoking did not constitute employer conduct, however, claim- ant failed to satisfy the procedural requirement. SHB • •
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• • • NOVEMBER 3, 1995 WORKPLACE: UNFAIR LABOR PRACTICES [28] Imperial Floral Distributors, Inc. and Amal- gamated Industrial and Toy and Novelty Workers ofAmerica, Local 223,1995 WL 592490 (National Labor Relations Board) (decided September 29, 1995) The National Labor Relations Board ruled against the now-defunct Imperial Floral Distributors, finding that the firm engaged in a number of unfair labor practices including implementation of a facility-wide smoking ban in retaliation for employees pursuing union activities. The employer's retaliatory activities began in November 1994 and lasted until its Glen- dale, New York, facility closed in December 1994. The employer failed to answer the charges filed by NLRB's general counsel. PRISONER CASE [29] Peeples v. Department of Corrections, 1995 WL. 600520 (Ohio Court of Appeals) (decided October 12, 1995) An Ohio appeals court has dismissed a claim by Peeples, a prisoner at Mansfield Correctional Institu- tion, for damages of $2,500 allegedly caused by ETS exposure. Injuries alleged by Peeples included "eye irritation, continuous sneezing, headaches and sinus congestion." The court refused to review Peeples' claim because he failed to provide the court with a copy of the trial transcript. The policy at Mansfield permits inmates to infor- mally pair with smoking or nonsmoking cellmates and request a transfer as desired. All nonsmoking inmates were already paired at the time Peeples filed his complaint, forcing him to share a cell with a smoker. By the time the appeals court reviewed the case, however, Peeples had been transferred to a cell where he lived alone. Thus, the court declined to address the adequacy of the prison's cell-assignment policy, finding the issue moot. 9 LEGAL ISSUES AND DEVELOPMENTS [30] "Air Quality Awareness Leads to Building Cleanup Efforts," R. Banham, Journal of Commerce, October 6, 1995 The author of this article attributes heightened public awareness of building-related illnesses to burgeoning litigation alleging environmental contaminants or flawed design as the sources of illness. Examples of lawsuits discussed include DuPage County v. Hellmuth, Obata e- Kxssabaurn, et al. (Kane County, Illinois), in which architects and contractors involved in construc- tion of the DuPage County courthouse were absolved of liability for installing a faulty ventilation system that purportedly caused the illness of hui..ireds of employ- ees and the temporary closing of the building. See issue 89 of this Report, January 20, 1995. "The lawsuits have shown building designers just how lawyers are treating this issue, and how they can become embroiled in litigation,"says Richard Silberman, a technical project manager of Healthy Buildings International Inc., a Fairfax, Virginia-based IAQ investigation company. "[Litigation] seems to be translating into professional concern at the design and construction stage." OTHER DEVELOPMENTS [31] Revision Committee Member to Co-direct New Policy Institute Jonathan Samet, a member of the ASHRAE Standard 62-1989 Revision Committee, as well as an OSHA- retained expert witness and a former member of EPA's SAB IAQTHEC Committee, has been named co- director of a new institute established by the Johns Hopkins University School of Hygiene and Public Health. According to a press report, the Risk Sciences and Public Policy Institute will promote research and education on risk issues and provide a national forum for related science and policy debates. Funding for the institute was provided by the CSX Corp. In a recent institute newsletter, Samet and co-director . Thomas Burke discussed the diminished role of public health agencies and academic institutions in public health risk assessments and policy making. They SHB
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10 posited that many federal and state environmental regulatory strategies have been ineffective because of overreliance on animal experimentation instead of human exposure surveillance and failure to incorpo- rate "the tools of traditional public health" such as public values. Samet and Burke advocate risk assessment as a method of preventing health risks, not predicting them. "[T]he current knowledge base for risk assess- ment is very limited for understanding actual impacts on the health of the public," they write. "The public health approaches of epidemiology, health surveillance and exposure surveillance can serve a valuable role in expanding the knowledge base on exposure and human health outcomes by providing evidence of the exposures and health effects actually sustained by the population." See Risk Policy Report, October 20, 1995. [32] Multiple Chemical Sensitivity Symposium Agenda Ignites Controversy Recent protests over an allegedly biased agenda for a Johns Hopkins University-sponsored symposium ultimately resulted in significant changes to the program. According to a press report, members of MCS Referral & Resources, an advocacy group for people with multiple chemical sensitivities (MCS), objected to the "bias and limited scope" of an October 30, 1995, program titled "Multiple Chemical Sensi- tivities: State of the Science Symposium" held in Baltimore, Maryland. Citing the program's dearth of MCS patients and the anti-MCS bias of selected speakers, MCS advocates objected to the fact that Johns Hopkins University's Office of Continuing Medical Education approved the program for American Medical Association Category 1 continuing medical education credit. Apparently, criteria for Category 1 activities require a balanced program that includes diverse viewpoints. The MCS advocates also called for symposium materials to provide better disclosure of the bias of the National Medical Advisory Service, Inc., a symposium cospon- sor that they claimed "specializes in providing anti-MCS expert testimony." In response to the vehement campaign, symposium planning committee members added two speakers whom MCS advocates consider well qualified and free of anti- MCS bias. See Risk Policy Repom October 20, 1995. ETS/IAQ REPORT, ISSUE 1 10 [33] Smoking Ban Suspended for Peace Negotiations U.S_ officials have reportedly suspended a smoking ban at Wright-Patterson Air Force Base in Ohio to accommodate representatives of Bosnia, Croatia and Serbia who are in residence there, attempting to negotiate a Balkan peace agreement. The Department of Defense, citing the EPA Risk Assessment on ETS, imposed a smoking ban at all U.S. military establish- ments on April 8, 1994. According to a U.S. official who toured the rooms assigned to residents of the former Yugoslavia, "there was a lot of smoking going on." See Reuters, Limited, November 1, 1995. [34] Smoking Provides Opportunity for Peaceful Exchange An editorial in the Journal of Commerce reports that smoking restrictions in Washington, D.C., have led employees of the Kuwaiti and Israeli embassies to gather in a neighboring courtyard to smoke. Noting that initial encounters must have been uncomfortable because contact between Kuwait and Israel is prohib- ited, the editors conclude, "perhaps it's sharing something forbidden, or the camaraderie between people having a smoke, but the supposed enemies now seem fairly friendly." See Journal of Commerce, October 16, 1995. [35] U.S. Hotels Increase Number of Nonsmoking Rooms Demand for nonsmoking guest rooms is causing American hotel chains to increase the number of such rooms in their properties. A recent press report indi- cates that guest requests for the rooms have led Embassy Suites to boost the proportion of its non- smoking suites from 51 percent to 75 percent. Other hotel chains that also have expanded the number of rooms available to nonsmokers include Hampton Inns, Marriott Hotels Corp. and Hyatt Hotels Corp. A Marriott Hotels spokesman reportedly stated that demand for nonsmoking meeting rooms is also rising. According to figures from the American Hotel & Motel Association, approximately 85 percent of hotels nationwide offer nonsmoking rooms. In those hotels, the mean percentage of nonsmoking rooms offered is 46 percent. Apparently, hotels with international SHB •
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• • • NOVEMBER 3, 1995 travelers hesitate to increase the number of nonsmok- ing rooms because international guests frequently request smoking accommodations. See Los Angeles Tim-es, October 19, 1995. SCIENTIFIC/TECHNICAL ITEMS UPCOMING SCIENTIFIC MEETINGS Appendix C lists upcoming scientific meetings discussed in this and past issues of this Report. [36] "Advances in Medical Surveillance for Environ- mental and Occupational Health: From Exposure Onset through Health Outcome," Bethesda, Maryland, December 6-8, 1995 According to the brochure, the purpose of this conference is to examine issues and techniques of medical surveillance and associated health outcomes in the workplace and the environment. Scheduled speakers include Lynn Goldman (EPA) and Joseph Dear (OSHA) as well as other individuals from several federal and state regulatory agencies. This conference is sponsored by the Society for Occupational and Envi- ronmental Health and co-sponsored by the Agency for Toxic Substance and Disease Registry, National Center for Environmental Health, NIOSH, CDC, and DOE. [37] 1996 ASHRAE Winter Meeting, Atlanta, Georgia, February 17-21, 1996 The preliminary technical program reports that this ASHRAE-sponsored conference will be held at the Georgia World Congress Center. Topics for the symposia and technical sessions include HVAC systems, building design and IAQ. Society committee meetings will also be conducted. [38] Society of Toxicology 35th Annual Meeting, Anaheim, California, March 10-14, 1996 According to the preliminary information for this conference, technical sessions will offer information from leading scientists on topics that include genetics, physiology, animal models, and biomarkers. Activities will include plenary sessions, workshops, and poster and paper presentations. One reported highlight of this conference is that casual attire will be allowed for the first time ever. il [39] "IAQ'96: Paths to Better Building Environ- ments," Baltimore, Maryland, October 6-8, 1996 The 10th ASHRAE IAQ conference, IAQ'96, will reportedly address IAQ complaints and legal issues, __ improving health and productivity through better HVAC designs, VOC sources and control, and humidity and biological contaminants. This conference is co-sponsored by ASHRAE, EPA, NIOSH and several professional societies, and will be held at the OMNI Inner Harbor Hotel in Baltimore. LUNG CANCER [40] "Uncertainties in Lung Cancer Risk Estimates Reported for Exposure to Environmental Tobacco Smoke," A.J. Gross, Environinetrics 6: 403-412, 1995 [See Appendix B] In the introduction of a four-part exchange, Gross points out a number of assumptions used in the EPA Risk Assessment on ETS, and proposes that the assumptions and uncertainties in EPA's calculations cast doubt on the quantitative estimate of lung cancer deaths attributed to ETS by the agency. [41] "Environmental Tobacco Smoke and Lung Cancer: Uncertainties in the Population Esti- mates But Not in the Causal Association -A Rejoinder to Gross," S. Bayard, J. Jinot, and G. Flatman, Environrnetrics 6: 413-418, 1995 [See Appendix B] In a reply to Gross, EPA personnel defend the methodology of the EPA Risk Assessment on ETS. [42] "Uncertainties in Lung Cancer Risk Estimates Reported for Exposure to Environmental Tobacco Smoke - A Rejoinder to Gross," J.A. Hanley, Environmetrics 6:419-422, 1995 Lee_ Appendix B] In a reply to Gross, this author suggests that, despite uncertainties and statistical concerns, preventive public health actions should proceed. SHB
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12 [43] "Uncertainties in Lung Cancer Risk Estimates Reported for Exposure to Environmental Tobacco Smoke Revisited - A Response to Bayard/Jinot/Flatman and Hanley," A.J. Gross, Environmetrics 6: 423-424, 1995 [See Appendix B] In the closing article of the exchange between Gross, EPA staff, and Hanley, Gross replies that he is "totally unconvinced" that EPA has proven a causal relation- ship between ETS exposure and lung cancer risk. CARDIOVASCULAR ISSUES [44] "Risk Factor Profile of Nonsmokers with Peripheral Arterial Disease," F.G.R. Fowkes, J.T. Dunbar, and A.J. Lee, Angiology 46: 657- 662, 1995 [See Appendix B] In an attempt to establish a risk factor profile for never-smokers with peripheral artery disease, the authors of this Scottish study analyzed smoking history questionnaires, which included ETS exposure, in addition to physical and blood measurements of 1,592 men and women. With the exception of the claim that "among never-smokers, women could possibly be more at risk for PAD [peripheral artery disease] than men," no unique risk profile was presented. [45] Letters to the Editor Regarding "Inhalation of Sidestream Cigarette Smoke Accelerates Develop- ment of Arteriosclerotic Plaques," A. Penn and C.A. Snyder, Circulation 88: 1820-1825, 1993 Letters to the editor commenting on this study have recently been published. Penn and Snyder originally reported that sidestream smoke exposure caused an increased growth of fatty plaques in the blood vessels of chickens. See Issue 62, Item 38 of this Report. The letters, one by M.J. Merrilees and K. Mengersen and a reply by the authors of the original study, appear at Circu7ation 91: 3022-3023, 1995. Merrilees and Mengersen comment that the claimed "significantly enhanced growth of aortic plaques" reported by Penn and Snyder relies upon acceptance of the method used to measure plaque growth. They then discuss the specific shortcomings of Penn and Snyder's ETS/IAQ REPORT, ISSUE 110 technique and suggest the possibility that their results might have been influenced by sample size, sampling bias or a combination of sampling bias and differences in blood vessel size. Merrilees and Mengersen conclude that, in light of the weakness of the epidemiological evidence on the claimed effects of ETS on heart disease, "it is particularly important that data support- ing a direct effect are scrutinized carefully and analyzed correctly and all alternative interpretations ruled out." In their reply, Penn and Snyder explain how their method for calculation of plaque size was designed specifically to avoid the introduction of errors due to differences in vessel size. They claim that they reevalu- ated their data according to Merrilees and Mengersen's --- -- - -- criticisms and found no signif cant difference. In response to the criticisms about sample size and sampling bias, they suggest that the number of animals was adequate. Penn and Snyder do, however, deny Merrilees and Mengersen's request that they make available more raw data. Penn and Snyder write that they did not state that "ETS is a causative agent," only that it "promotes" plaque development. They suggest that the difference between "causation" and "promo- tion" is not merely a semantic one, but one that "reflects the mechanism by which ETS and other environmental agents act in this system." RESPIRATORY DISEASES AND CONDITIONS - CHILDREN [46] "Socioeconomic Status and Indicators of Asthma in Children," P. Ernst, K. Demissie, L. Joseph, U. Locher, and M.R. Becklake, American Journal of Respiratory and Critical Care Medi- cine 152: 570-575, 1995 [See Appendix B] The authors of this Canadian study report that exercise-induced bronchospasm "was not found to be associated with either maternal smoking during pregnancy or current household ETS exposure." They suggest that environmental factors may contribute to asthma morbidity of children from poor families. SHB •
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• • • NOVFMBER 3, 1995 REPRODUCTIVE AND DEVELOPMENTAL ISSUES [47] "SIDS Epidemiology and Incidence," T. Dwyer and A.L. Ponsonby, Pediatric Annals 24: 350- 356, 1995 [See Appendix B] In this review, the authors comment on the apparent relationship between prone sleeping position and SIDS risk; they also suggest that parental smoking may be an important risk factor. [48] "Functional and Developmental Studies of the Peripheral Arterial Chemoreceptors in Rat: Effects of Nicotine and Possible Relation to Sudden Infant Death Syndrome," H. Holgert, T. Hokfelt, T. Hertzberg, and H. Lagercrantz, Proceedings of the National Academy of Sciences USA 92: 7575-7579, 1995 [See Appendix B] Based on data from experimental exposures of rat pups, the authors suggest that nicotine may impair the response to low oxygen levels, such as might occur during periods of apnea [a cessation of normal breath- ing], a condition sometimes associated with SIDS. OTHER HEALTH ISSUES [49] "Risk Factors for a First Febrile Seizure: A Matched Case-Control Study," A.T. Berg, S. Shinnar, E.D. Shapiro, M.E. Salomon, E.F. Crain, and W.A. Hauser, Epilepsia 36: 334-34 1, 1995 [See Appendix B] This study reviews risk factors for infant seizures associated with fever. The authors report that "height of temperature" and family history of seizures were risk factors, and that maternal smoking during pregnancy was a "marginally significant predictor" of risk. ETS exposure was reportedly not associated with increased seizure risk. [50] "Relation Between Passive Tobacco Smoke Exposure and the Development of Bacterial Meningitis in Children," R.C. Bredfeldt, S.R. Cain, G.E. Schutze, T.M. Holmes, and L.A. McGhee, Journal of the American Board of Family Practice 8: 95-98, 1995 [See Appendix B] Based on a telephone survey, the authors report that ETS exposure is "associated with increased risk of bacterial meningitis in children." [Meningitis is an inflammation of the membranes that surround the brain and spinal cord, and is generally bacterial or viral in origin.] [51] "Involuntary Smoking and Children's Health," J.M. Samet, E.M. Lewit, and K.E. Warner, Current Problems in Pediatrics 25(6): 189-204, 1995 [See Appendix B] In a lengthy review paper, the authors discuss a wide variety of health endpoints that have reportedly been associated with childhood exposure to ETS or with maternal smoking during pregnancy. They suggest that public policy should strive to reduce ETS exposures of children. ETS EXPOSURE AND MONITORING [52] "Are Self-Reports of Smoking Rate Biased? Evidence from the Second National Health and Nutrition Examination Survey," R.C. Klesges, M. Debon, and J.W. Ray, Journal of Clinical Epidemiology 48: 1225-1233, 1995 [See Appendix B] This study compared self-reports of the amount smoked with an "objective" measure of smoking (carboxyhemoglobin level). The authors report that smokers round estimates of their smoking rates to multiples of 10 cigarettes. Self-reports of smoking are used in epidemiologic studies as a surrogate for ETS exposure; this study suggests a potential source of inaccuracy associated with this approach. SHB
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14 GEN OTOXICITY AND MUTAGENICITY [53] «Genetic-Environment Interactions an Low- Level Exposure to Carcinogens," P. Vineis and T. Martone, Epidemiology 6: 455-457, 1995 [See Appendix B] This article explores genetic predisposition for cancer and the importance of addressing reported "susceptibil- ity" in epidemiologic studies of low-level exposures. The authors propose that genetics may interact with exposures to influence cancer risk, citing ETS as one possible exposure. INDOOR AIR QUALITY [54] "Possible Mechanisms for the Respiratory Tract Effects of Noncarcinogenic Indoor-Climate Pollutants and Bases for Their Risk Assess- ment," G.D. Nielsen, Y. Alarie, O.M. Poulsen, and B.A. Nexo, Scandinavian Journal of Work and Environmental Health 21: 165-178, 1995 [See Appendix B] This article suggests that occupational exposure levels for indoor air constituents should form the basis for risk assessments of noncancer respiratory effects. The authors propose that this approach would be cost- effective and reduce the number of assumptions used in risk assessments. [55] "Air Nicotine and Saliva Cotinine as In icators of Workplace Passive Smoking Exposure and Risk," J.L. Repace, J. Jinot, and S. Bayard, manuscript submitted for publication, available to the public as Exhibit 340-1753 in OSHA Docket H-122 [See Appendix B] This manuscript (marked "to be submitted for publication"), appeared in OSHA's post-hearing submission to the docket for its rulemaking on indoor air quality and workplace smoking, and thus, became available to the general public. The authors, who have been involved to varying degrees in the development of the EPA Risk Assessment and OSHA's Proposed Rule, use a mathematical model to predict nicotine and cotinine levels in workers exposed to ETS. After attempting to correlate those levels to lung cancer risk, ETS/IAQ REPORT, ISSUE 110 they claim that, in 65% of workplaces, unrestricted smoking results in ETS levels that correspond to a significant lung cancer risk of one in 1,000. STATISTICS AND RISK ASSESSMENT [56] "Heterogeneity in Meta-Analysis of Data From Epidemiologic Studies: A Commentary," G.A. Colditz, E. Burdick, and F. Mosteller, American Journal ofEpiderniology, 142: 371-382, 1995 [See Appendix B] - The authors review sources of heterogeneity among epidemiologic studies and discuss how heterogeneity can affect the analysis and interpretation of meta- analysis results. Although ETS is not specifically mentioned, this discussion of meta-analytic methods applies to epidemiologic studies and risk assessments relating to ETS. [57] "Invited Commentary: Benefits of Heterogene- ity in Meta-Analysis of Data From Epidemiologic Studies," J.A. Berlin, American Journal ofEpiderniology 142: 383-387, 1995 [See Appendix B] This author proposes that study heterogeneity may benefit meta-analysis of epidemiologic data by provid- ing insight to sources of variation. ETS is not discussed; however, the author's emphasis on proper methodology and identification of heterogeneity is relevant to ETS epidemiology and risk assessments. SHB •
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NOVEMBER 3, 1995 15 • IN EUROPE ~.r AROUND THE 26, 1995. See The BritishMedicalJourncr4 October 21, _ W~ R~ D 1995; Gazeta Mercanti4 October 24, 1995 - REGULATORY AND LEGISLATIVE MATTERS ARGENTINA • • [58] Rosario Adopts Restaurant Smoking Ordinance The city of Rosario, population one million, recently adopted a restaurant smoking ordinance requiring establishments larger than 40 square meters to establish smoking and nonsmoking sections. Restaurants smaller than 40 square meters must choose whether to prohibit or permit smoking throughout the entire facility. In contrast to the Buenos Aires restaurant smoking ordinance that reserves 20 percent of total space for nonsmokers, the Rosario ordinance requires restaurant owners to dedicate more space to nonsmokers than to smokers. See Clarin, October 7, 1995. BRAZIL [59] Souza Cruz Launches Freedom of Choice Campaign So-uza Cruz has reportedly launched a "freedom of choice" newspaper advertising campaign in the city of Sao Paulo, intended to increase respect for smokers. The group's communication director apparently believes that the city's recently imposed restaurant smoking ban makes it impossible for smokers and nonsmokers to co-exist peacefully. The law was initially introduced by the city's mayor in February 1995 but was appealed through the courts by restaurant owners. In mid-September, an intermediate court judge reportedly ruled that the ban should stand until the state high court determined its constitutionality. The ban was reintroduced later that month amid what was described as intense media coverage and national debate. Several national newspapers reportedly ran lengthy daily features covering the issue. A 23-year-old woman was photographed in a restaurant "beaming (and smoking)," apparently proud to be the first person fined UK$250 for breaking the law. Further details concern- ing this matter appear in issue 98 of this Report, May [60] Sao Paulo Governor to Approve Restaurant Smoking Restriction Sao Paulo state governor Mario Covas is reportedly - poised to approve a proposal requiring restaurants larger than 100 square meters to establish separate smoking and nonsmoking areas. See Reuters, October 27, 1995. EUROPEAN UNION [61] Parliament Calls for Antismoking Measures A press report indicates that the European Parliament reintroduced measures for plans on cancer and AIDS prevention at its late October 1995 meeting. In conjunction with those measures, MEPs reportedly requested an amendment restricting tobacco advertis- ing and smoking in public places. In reaction to the proposed restrictions, the European Hotel Associations released a statement expressing concern that smoking restrictions in public places would threaten the livelihoods of many tourist venues. See The Reuter European Comrnunity Report, October 25, 1995, and ANSA, October 24, 1995. OTHER DEVELOPMENTS AUSTRALIA [62] WA Health Department Launches Health Information Campaign An advertising and information campaign addressing the purported effects of ETS on young children has reportedly been launched by the Western Australia (WA) Health Department. The AU$300,000 cam- paign apparently contends that more children are hospitalized due to ETS exposure than from automo- bile accidents. The department's health promotion services director is quoted as stating that in WA some 1,700 cases of lower respiratory tract infections in children under the SHB
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16 age of 18 months result annually from ETS exposure. The annual cost of treating children with asthma purportedly aggravated by ETS is estimated at AU$2.4 million. See Australian Associated Press, October 17, 1995; WestAustralian, October 19, 1995. EUROPEAN UNION [63] Philip Morris Sponsors New European Ad Campaign According to a press report, Philip Morris Europe recently sponsored a new series of advertisements in major news publications as part of the company's continuing "courtesy" campaign. The ads reportedly display two photographs: one of a man eating a meal and the other of a man in an office. The caption accompanying the photos reads, "If you want to smoke who should you ask? Someone in the same room, or someone who isn't?" The ads conclude with the statement, "With courtesy and consideration, smokers and nonsmokers can and do work it out for them- selves." See Pan-European Press, October 23, 1995. G REECE [64] International Trade Group Adopts Risk Assess- ment Principles According to a press report, the International Council of Chemical Associations (ICCA) adopted a set of principles for risk-based decision making during a recent meeting in Athens, Greece. ICCA advocates public policies regarding risk that emphasize (i) "cooperation between government, industry and other interested parties"; (ii) "priorities based on sound judgments of risk that take all three elements into account"; (iii) "using scientifically sound risk assess- ment methods"; (iv) "cost-effective management of risk, applying a precautionary approach"; and (v) "public participation to assure consistent attention to the social dimension of policy." The risk principles will apparently be distributed to member associations which will then distribute them to member companies. See Risk Policy Report, October 20, 1995. ETS/IAQ REPORT, ISSUE 110 [65] Uncertain Economic Impact of KI.M Smoking Restrictions A recent opinion poll commissioned by a tobacco lobby group reportedly indicates that up to 25 percent of Dutch air travelers will avoid KLM flights now that the airline has implemented smoking restrictions on many of its flights since October 29, 1995. The Dutch airline's new smoking policy prohibits smok- ing on all European and trans-Atlantic flights, as well as those to Australia and Singapore. The survey results appear to conflict with customer surveys by KLM on which the airline based the new policy, which reportedly showed a "large majority" of passengers welcome a smoking ban. KLM reports that passenger complaints concerning smoking have increased 70 percent since 1991. See The Reuter European Business Report, October 24, 1995. UNITED KINGDOM [66] Smoking Restrictions Imposed on Chartered Airline Flights Effective immediately, action taken by the Federation of Tour Operators (FTO) apparently prohibits smok- ing on 90 percent of Britain's chartered flights. According to a press report, the FTO has convinced the nation's major tour companies, including Thomsons, Airtours and First Choice, to prohibit smoking on flights lasting up to six hours. The secretary general of the FTO said imposition of the restrictions was driven by pressure from passengers. "There are more anti-smokers than there are smokers, and it was clear more airlines were gradually banning it," he said. See The Independent, November 1, 1995. [67] Smoking Encounter at "Faulty Towers" Jack and Margaret Beaumont, an elderly couple touring the UK on a bus with 40 other passengers, were forced to pay a UK$20 surcharge when checking out of the Anchorage Hotel in Torquay, Devon- better known as "Faulty Towers" in a 1970s television comedy-because they smoked in their room during their stay. Hotel owner Barry Page-Dove defended the charge as the cost entailed in purging the room of SHB •
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• • NOVEMBER 3, 1995 cigarette odor. "We are advertised as a nonsmoking hotel," Page-Dove explained, "so the next guest who arrived would have been offended." Although they begrudgingly paid the additional amount, the Beaumonts were unrepentant, explaining that they paid "under protest" and that the incident "left a nasty taste." See The Daily Telegraph, October 17, 1995; PressAssociation News, October 16, 1995. UNITED NATIONS [68] Headquarters Adopts Smoking Restrictions Smoking restrictions were reportedly implemented at the United Nations headquarters on October 24, 1995, the same day more than 100 world leaders met there to celebrate the organization's 50th anniversary. Smokers in the UN, however, retain more options than many New Yorkers forced outside to smoke. According to press reports, several large meeting halls and one- third of dining areas in the UN will be reserved for smokers. An internal communique introducing the policy reportedly explained that the UN has a moral responsibility for providing a safe environment for its staff. See Agence France Presse, October 25, 1995; Reuters World Service, October 24, 1995. SHB 17
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• • • NOVEMBER 3, 1995 APPENDIX A 104TH CONGRESS REGULATORY REFORM LEGISLATION A-1 Republicans' regulatory reform agenda; would suspend judicial or statutory rulemaking deadlines; extends moratorium an additional six months for businesses with 100 or fewer employees. Senate bill gives Congress 45 days in which to review and disapprove new rules. • H.R. 5/S. 1(Contract) aApproved by the House on February 23, 1995; Unfunded Mandate Reform Act of 1995 amendment to exempt smoking or tobacco products Would curb the ability of Congress to impose un- rulemaking from moratorium defeated; Senate bill funded federal requirements on state, local and tribal approved, as amended, by unanimous vote on March governments; legislation contains a regulatory account- 29; on May 17, House approved S. 219 as amended by - b ' 'hH 4 R 0 S 2 d h ability and reform section requiring federal agencies assess the effects of federal regulations on state and local governments. to su sutution wit . , . 19 returne . 5 to t e Senate on May 18; S. 219 sent to conference commit- tee and conferees appointed on June 16. • H.R. 690' >~-President Clinton signed bill into law on March 22, 1995 (P.L. No. 104-4). • H.R. 9/reissued in part as H.R. 1022 (Contract)1 Risk Assessment and Communication Act of 1995 Defines major rule in terms of a $25 million or more impact on economy; contains provisions permitting industry scientists to sit on peer review panels and judicial review of agency compliance with statute. Amended by substitution with H.R. 830, H.R. 925, H.R. 926, H.R. 1022. :?!-H.R 1022 approved by the House on February 28, 1995, and as part of H.R 9 which was approved on March 3. Referred to Senate Committee on Governmen- tal Affairs; public oversight hearing held on July 12, in Senate Committee on Environment and Public Works. • H.R. 122 Regulatory Sunset Act of 1995 Would require periodic review of every regulation enacted by executive agencies; applies to existing and new regulations; regulations would no longer be effective unless authorized by a Regulatory Sunset Commission. >-Pending in committee; no hearings yet scheduled. • H.R. 450/S. 219 Regulatory Transition Act of 1995 Would place a moratorium on federal agency rulemaking, suspending the effectiveness of any rulemaking action taken or made effective between November 20, 1994, and the earlier of December 31, 1995, or until the enactment of laws embodying the Risk Assessment and Cost-Benefit Analysis Act of 1995 Defines major rule in terms of a $25 million or more impact on economy. )!-Pending in committee; no hearings yet scheduled. • H.R. 821/S. 3431 Middle Clrus Reguhrtory ReliefAct of 1995 Contains provision permitting industry scientists to sit on peer review panels; also gives Congress veto power over any proposed rule. DHouse bill is pending in committee; no hearings yet scheduled; Senate bill through committees and pending in full Senate. • H.R. 839 Stop Regulating Our Small Businesses Act of 1995 Would place a moratorium on federal rulemaking actions affecting businesses with 100 or fewer employees. )!-Similar language incorporated in H.R. 450; pending in committee; no hearings yet scheduled. • H. R. 926 Regulrrtory Reform and ReliefAct Defines major rule in terms of a $50 million or more impact on economy; would require regulatory impact analysis for major rules, and would permit increased opportunity for public participation in rulemaking and judicial review of final rules. Amended to give small businesses one year after enactment of a final rule to seek judicial review of agency compliance with Regula- tory Flexibility Act of 1980. SHB
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A-2 ~!-Approved by the House on March 1, 1995; referred to Senate Committee on Governmental Affairs; incorporated in H.R. 9 and approved by the House on March 3. • H.R. 994/S. 511 Regulatory Sunset and Review Act of 1995 Would require periodic review and automatic termina- tion of federal regulations. 3!-Marked up in committee on July 18, 1995, and reported out with an amendment in the nature of a substitute; committee report filed on October 19; approved by Judiciary Committee on October 31. • H.R. 1636 Regulratory Accounting Act of 1995 Would require the issuance of an accounting statement and associated report every two years to provide a more complete accounting of national expenditures and corresponding benefits of federal regulatory programs. DIntroduced on May 15, 1995; referred to House Committee on Government Reform and Oversight; no hearings yet scheduled. • H.R. 1681 General Notice ofProposed Rulemaking, Provision Would provide that certain regulations shall not take effect unless published in final form no later than 18 months after the date of publication of general notice of proposed rulemaking. aPending in committee; no hearings yet scheduled. • H.R. 1839 Regulatory Harmonization Act Would require executive agencies to publish and submit for public comment a list of regulations that "impose requirements which are potentially in conflict" with the regulations of other agencies or with legisla- tion. The agencies would then be required to propose changes to eliminate the conflict. )!-Pending in committee; no hearings yet scheduled. • H.R. 1937 Small Business Advocacy Act of 1995 Would facilitate small business involvement in the regulatory development processes of EPA and OSHA ETS/IAQ REPORT, ISSUE 110 by establishing small business advocacy review panels which would evaluate proposed significant rules and their impact on small businesses; applies to rules with an impact greater than $50 million; permits conduct of surveys to address impact of proposed rules on small businesses. nPending in committee; no hearings yet scheduled. • S. 100` Regulrrtory Accountability Act of 1995 Defines major rule in terms of a$100 million or more impact on economy; requires regulatory analysis and review and increased opportunity for public participa- tion in rulemaking. aPending in committee; no hearings yet scheduled. • S. 229' Certain EPA Risk Assessments, Requirements Would require EPA administrator to conduct risk assessments and cost-benefit analyses in promulgating regulations relating to human health and the environ- ment. z-Pending in committee; no hearings yet scheduled. •S.291` Regulrztory Reform Act of 1995 Defines major rule in terms of a $100 million or more impact on economy; requires publication of schedule for review of existing major rules seeking proposals from public for rule modifications or alternatives; would require consideration of "market-based mecha- nism" in assessments, giving regulated persons opportunity to trade "increments of compliance responsibility" established by rule. aApproved by Senate Energy and Governmental Affairs Committees on March 23; Senate staffers negotiating to reconcile with S. 343 and S. 333. • S. 333` Department of Energy Risk Management Act of 1995 As introduced, this bill only applied to the Department o Energy; a "trailing amendment" introduced on February 3, 1995, would extend coverage of the bill to "any agency in connection with health, safety and risk to natural resources" and would apply to rules costing industry more than $50 million annually. Additional SHB •
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• • • NOVEMBER 3, 1995 amendment offered on March 2, would require the EPA Administrator to conduct risk assessments for those chemicals added to its Toxic Release Inventory and would prohibit risk assessments as a condition for issuance of a license or permit. DApproved by Senate Energy Committee on March 29; Senate staffers negotiating to reconcile with S. 343 and S. 291. • S. 343 ` Comprehensive Regulatory Reform Act of 1995 Most aggressive regulatory reform legislation intro- duced; defines major rule in terms of a $50 million or more impact on economy; contains provision permit- ting industry scientists to sit on peer review panels; gives Congress veto power over any proposed rule; suspends jurisdiction of courts to enforce rulemaking deadlines; gives affected individuals right to petition federal agencies to perform cost-benefit analysis of existing rules; would also give courts authority to review agency compliance with bill's mandates. aDebated on floor of Senate on June 28, 29, and July 10; amendments adopted raising threshold from $50 million to $100 million and clarifying that bill's cost- benefit test would not override existing laws precluding such cost considerations; three attempts to achieve cloture failed. • S. 348 Regulatory Oversight Act of 1995 Defines major rule in terms of a$100 million or more impact on economy; would require submission to Congress of major rules for its approval. z-Pending in committee; no hearings yet scheduled. • S. 350 Regulatory Flexibility Amendments Act of 1995 Would permit affected small entities to petition for judicial review of any agency certification that a rule would not have a significant economic impact on small entities or any agency "final flexibility analysis." ~-Pending in committee; no hearings yet scheduled. • S. 439 - A-3 Regulatory Reform Commissions Act of 1995 Would require establishment of three commissions to review regulations issued by the EPA and the Depart- ments of Labor and the Interior. y-Pending in committee; no hearings yet scheduled. • S. 585/H.R. 1979 Small Business Regulatory Bill of Rights Act Would establish rights for "small entities" prior to, during and following agency investigative or enforce- ment actions. The "prior to" rights include no-fault for voluntary compliance audits. The rights to be provided during an enforcement action include Miranda-type warnings. Fines for regulation violations would not be paid to finance the enforcing agency, rather they would "be used for reduction of the Federal deficit." >-Pending in committee; no hearings yet scheduled. • S. 917 Small Business Advocacy Act of 1995 Would establish small business advocacy review panels to provide input in rulemaking procedures of EPA and OSHA where rulemaking would have "an annual aggregate impact on State, local, and tribal governments and the private sector in an amount equal to not less than $50,000,000; and an impact on small businesses." aPending in committee; no hearings yet scheduled. • S. 1001' Regulatory Procedures Reform Act of 1995 Would reform regulatory procedures; defines major rule in terms of a$100 million or more impact on economy; exempts some agency action from judicial review; provides for agency review of previously adopted rules; contains extensive provisions for con- gressional review of agency rulemaking; requires agencies to establish risk priorities; requires President to submit periodic accounting statement to Congress estimating annual costs and benefits of federal regula- tory programs. aPending in committee; no hearings yet scheduled. SHB
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A-4 ETS/IAQREPORT, ISSUE 110 • S. 13461 Regulatory Review Act of 1995 Would provide for the periodic review and termination of "significant rules"; would permit public petitions and Congressional requests for review; prescribes procedures for such review. nPending in committee; no hearings yet scheduled. • S. 13502 Small Business Fair Treatment Act of 1995 Would require federal agencies to prepare "compliance guides" for small business owners explaining applicable regulations and would prevent enforcement of rules against small entities where guides have not been prepared; would also permit issuance of "no action" letters regarding enforcement of federal regulations against small businesses. ~!-Pending in committee; no hearings yet scheduled. 'These bills all contain cost-benefit analysis, risk assessment and risk characterization requirements. ZThese bills have been introduced since the last Report was prepared. go SHB
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! • • NOVEMBER 3, 1995 APPENDIX B The numbers assigned to the following article sum- maries correspond with the numbers assigned to the synopses of the articles in the text of this Report. LUNG CANCER [40] "Uncertainties in Lung Cancer Risk Estimates Reported for Exposure to Environmental Tobacco Smoke," A.J. Gross, Environmetrics 6: 403-412, 1995 "Despite the continuing debate over the issue of ETS exposure and lung cancer, the EPA (1992) claims that between 2500 and 3300 lung cancer deaths (LCDs) per_year in non-smokers in the United States are associated with exposure to ETS. This range is slightly lower than the estimate of 3800 in an earlier draft of the same risk assessment." "The purpose of this paper is to review the methodol- ogy-used to obtain these estimates and to describe how they are by no means robust. I report on the methodol- ogy employed by EPA to arrive at the estimate of 3800 (EPA, 1990) and 3300 (EPA, 1992) LCDs that were obtained in the respective risk assessment documents. Then, focusing on the most recent EPA model, I illustrate how very small changes in some key model parameters lead to large changes in the estimate of LCDs in non-smokers associated with ETS. Finally, this paper considers whether adjustments to this estimate would be appropriate and concludes that in fact no reliable estimate can be obtained on the basis of the current data." "A variety of assumptions had to be made in order to obtain an estimate of the number of non-smokers exposed to ETS. For example, the excess relative risk in a non-smoker was assumed to be directly proportional to lifetime exposure to ETS." "A further assumption by EPA was that every person in the United States is exposed to ETS and that, at every age, an 'exposed' subject (defined on the basis of the epidemiologic studies' surrogate measure for ETS exposure as a never-smoking woman married to a smoking spouse) is exposed to ETS at a rate three times that of an 'unexposed' subject." - B-1 "The estimated total number of LCDs is highly dependent upon this background adjustment." "This ETS-related LCD estimate may well be mean- ingless for a number of reasons. For example, the proportion of non-smokers assumed to be exposed at the higher level (0.6) seems much too high." _ - - - "Moreover, the 3 to 1 ratio of exposures in non- smokers at the higher level of exposure to non-smokers at the lower level is likely to be inaccurate, since the small number of samples of cotinine levels in urine used to obtain this estimate are unlikely to be represen- tative of the general population. Also, no basis is established for the assumption that the risk of lung cancer associated with ETS exposure is the same in non-smoking men and women." "The methodology used to estimate the number of LCDs in non-smokers associated with ETS exposure was considerably different in the EPA's report. The most significant change was that the risk assessment for the U.S. population is based only on the U.S. epide- miologic studies as suggested by Fleiss and Gross (1991) and Gross (1992). This in itself is quite appro- priate and removes one of the criticisms of the earlier estimate. Unfortunately, the most recent estimate is still flawed and contains many uncertainties that are not considered by EPA." "Although EPA acknowledged `[t]here are likely to be true sex-based differences in relative risk due to differences in exposure to background ETS and differences in background [i.e., non tobacco-smoke- related] lung cancer risk,' estimates of the population mortality attributable to ETS were still calculated from the U.S. combined female studies in one scenario and the large, but as yet uncompleted U.S. female study (Fontham et al., 1991) in a second scenario." "In fact, the epidemiologic data do not show a statistically significant association between ETS and lung cancer. This being the case, there is no justifica- tion for corrections for background exposure when the principal measure of spousal smoke exposure fails to show a statistically significant association." "Estimation of the number of LCDs annually in non-smokers reportedly due to ETS in the United SHB _Q 11Z States is far from an exact or even approximace Q~ science....[M]inor to moderate changes in the k"`ti ~ C.D - - -- _ _ _ • _ -- _- - m
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B-2. model parameters lead to large changes in the estimated number of LCDs." "[E]ven if the estimated relative lung cancer risk of never-smoking married individuals exposed to spousal ETS, as-opposed to that of never-smoking married individuals [who] are not so exposed, were as large as 1.2 - which is still open to debate - the annual LCD estimate varies so considerably as a function of the other parameters ... that no confidence can be placed in such an LCD estimate." "Clearly, EPA has not given very much thought to the uncertainty of its estimates. The range presented by EPA in its report does not even take into account the confidence interval in its meta-analysis of the U.S. epidemiologic studies." "Clearly, there is so much doubt about so many of the fundamental parameters that are necessary to make these estimations of LCDs that any estimate is shrouded in uncertainty." "A final observation that calls into question this entire estimation procedure is that if RR., = 1.0 then the estimate is completely robust to all other param- eter changes. Under this condition, which cannot be ruled out by the existing epidemiologic data, the estimate of the number of LCDs in never-smokers due to reported ETS exposure in the U.S. is zero." [41] "Environmental Tobacco Smoke and Lung Cancer: Uncertainties in the Population Estimates But Not in the Causal Association - A Rejoinder to Gross," S. Bayard, J. Jinot, and G. Flatman, Environmetrics 6: 413-418, 1995 "Several aspects of the data give us confidence that the estimate of lung cancer deaths presented in EPA's report is a reasonable, albeit not an exact one. First, the totality of the evidence is conclusive that ETS is a human lung carcinogen. This is established by the weight-of-evidence approach developed in the report and outlined below. Second, both exposure measure- ments and biomarkers, as well as numerous acute effects, affirm that humans are exposed to and absorb ETS components in amounts large enough to be hazardous. Third, the epidemiology studies of ETS and lung cancer establish that increased risks are present at typical environmental levels, obviating the need for either high-to-low dose or animal-to-human ETS/IAQ REPORT, ISSUE 1 10 extrapolation, as is necessary for nearly every other environmental pollutant." "While we agree that estimation of the U.S. popula- tion tion risk should be based on the U.S. studies of ETS, such a quantitative assessment should be conducted after a qualitative hazard identification has established that there is an effect, based on an examination of all the scientific evidence. The EPA's conclusion that ETS causes lung cancer in non-smokers is based on the total weight of evidence, not just one analysis of the U.S epidemiology studies of ETS and lung cancer." "Since these epidemiology studies examine exposures to environmental levels of a pollutant to which virtu- ally everyone is exposed, the simple ever-versus-never exposed to spousal smoking comparison is not likely to be conclusive. It is critical to analyse the exposure- response information from those studies that provide lung cancer risk data by amount of spousal smoking. Of the 30 studies available at the time of the EPA assessment, 17 provided such data.... Every one of these 17 studies found an increased risk in the highest exposure group, and 9 of these were statistically significant, despite small sample sizes. The probability of this occurring by chance is less than 1 in 10 million. In addition, all 14 studies with sufficient data for trend analysis revealed positive exposure-response trends, and 10 of these were statistically significant. The probabil- ity of this occurring by chance is less than 1 in a billion. The consistency of these results from numerous studies provides compelling evidence that ETS causes lung cancer at actual environmental exposure levels. The exposure-response trends, in particular, provide strong evidence for causality." "Three new epidemiology studies of ETS and lung cancer have been published since the cutoff date for literature inclusion in the EPA report (Brownson et al., 1992; Stockwell et al., 1992; Liu et al., 1993). Each of these new studies concludes that there is an increased risk of lung cancer in non-smoking women exposed to ETS, consistent with the conclusions of the EPA report." "[U]ncertainties are inevitable in quantitative risk assessment, but we believe that 3000 is a reasonable point estimate, based on human data from actual environmental exposure levels. Furthermore, the estimate is sufficiently robust that we do not feel it is SHB •
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• • • NOVEMBER 3, 1995 necessary to do another meta-analysis and revise the number marginally every time a new U.S. study appears, especially since the meta-analysis is just one of two ways used to estimate the relative risk, which is then used to derive the population risk estimate." "The population risk estimates may not be exact, but they are scientifically supportable. The consistent results of the epidemiology studies, indicating in- creased risks of lung cancer at actual environmental exposure levels, and the acute and chronic respiratory effects evident in children from exposure to ETS establish that ETS is a serious and substantial public health problem." [42] "Uncertainties in Lung Cancer Risk Estimates Reported for Exposure to Environmental Tobacco Smoke - A Rejoinder to Gross," J.A. Hanley, Environmetrics 6: 419-422, 1995 "The article by Gross on EPA's risk estimates for lung cancer resulting from exposure to environmental tobacco smoke (ETS) is a vivid example of the difficul- ties faced by health protection agencies and regulatory bodies charges with interpreting and acting upon data bearing on the long-term health effects of a widespread environmental exposure." "In contrast to personal smoking, exposure to ETS is not always voluntary. Thus, the issues of protection are more far-reaching. We already have firm evidence of several health effects of ETS. What about its contribu- tion to lung cancer? What of the estimates by the EPA and the counter-estimates by Gross?" "First, when making estimates in a complex situation, it is important to include all quantifiable sources of uncertainty in the input parameters, even if some of the parameter estimates are no more than 'best guesses.' Second, by definition, a best guess may be too high or too low.... Third, it is not appropriate for a seemingly detailed re-analysis to simply list some assumptions without commentary." "My reaction is in the form of a plea to statisticians, scientists and assessors: do not be constrained by the hypothesis testing and confidence interval approaches of frequentist statistics.... In many situations, such as here, non-null hypotheses may deserve more credibility than the null; if so they should not be relegated to second- choices as possible explanations of the observed data." B-3 "In summary, frequentist analyses pretend that the meta-analysed studies bearing on the magnitude of the lung-cancer-ETS RR are the only data on this parameter. They ignore the large body of data on the carcinogenic and other effects of tobacco smoke in other settings; they do not allow us to argue by analogy, or to make use of expert opinions on the various aspects of the problem." "It is not at all clear that the burden of statistical proof should be on those who claim that RRz > 1. Rather, one could argue that the onus is on those who claim that RR2 = 1. In view of all that we have learned about the carcinogenicity of tobacco smoke, how can one start again 'from scratch' at RR = 1? To equate epidemiologic data which do not show a statistically significant association between ETS and lung cancer with `NO JUSTIFICATION FOR' assuming that RRZ > 1 is to deny history and to ignore all analogies. If we followed this naive and limited logic in our daily lives, we would encounter many nasty surprises." "Lastly, the history of public health has taught us that preventive actions can have considerable impact even if the exact disease mechanisms have not been elucidated. We do not always have to wait." [43] "Uncertainties in Lung Cancer Risk Estimates Reported for Exposure to Environmental Tobacco Smoke Revisited -A Response to Bayard/Jinot/Flatman and Hanley," A.J. Gross, Envirorzmetrics 6: 423-424, 1995 "Subsequent to this article, both Bayard et al. (1995) and Hanley (1995) submitted rejoinders in defence of the EPA estimate. The purpose of this note is to respond to these rejoinders and reiterate my initial position that the EPA estimate is based on a number of assumptions that cannot be supported by the existing data." - "With regard to Bayard et al. (1995), their claim that it 'is a reasonable albeit not an exact one,' cannot be substantiated by their arguments. First, there is disagreement that convincing evidence has been presented to establish ETS as a human carcinogen. Second, the exposure measurements and biomarkers, as well as a number of acute effects, when taken as a whole, still fail to confirm that human exposure to and absorption of ETS components are in large SHB
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B-4 enough amounts to be health hazardous. Finally, the cornerstone of the authors' rejoinder, the epidemio- logic studies of ETS and lung cancer, do not establish that `increased risks are present at typical environmen- tal levels.' . . . The 37 available epidemiologic studies of ETS that contain a plethora of biases and confounders that remain largely uncorrected, and/or unaccounted for, preclude any claim for a causal relationship between exposure to ETS and an increased risk of lung cancer in non-smokers." "Hanley (1995) provides a philosophical critique as opposed to commenting, scientifically, on my article. His principal points are two: (i) the burden should be on the tobacco industry to establish that ETS cannot cause lung cancer in non-smokers, and (ii) it is better to take the prudent approach when the health of the public is at stake even if it means 'throwing out the baby with the bath water.' If these principles were to be applied in a non-discriminatory way, most everything would be in danger of being banned." "I greatly appreciate the thoughtful comments of Bayard et al. concerning the scientific content of my article as well as the more philosophical comments of Hanley. However, I remain totally unconvinced that any evidence has been presented to change my original statement that the EPA has failed to show [that] even a single lung cancer death in non-smokers can be causally linked to ETS exposure." CARDIOVASCULAR ISSUES [44] "Risk Factor Profile of Nonsmokers with Peripheral Arterial Disease," F.G.R. Fowkes, J.T. Dunbar, and A.J. Lee, Angiology 46: 657- 662, 1995 "Cigarette smoking is a very common and important risk factor for peripheral arterial disease (PAD) such that a history of never having smoked is unusual in diseased subjects. The aim of this study was to deter- mine whether never smokers with PAD had a unique risk factor profile that put them at particularly high risk of disease. The study population was derived from the Edinburgh Artery Study, which is a cross-sectional random sample survey of 1592 men and women aged ETS/IAQ REPORT, ISSUE 110 fifty-five to seventy-four years. PAD was measured by means of the WHO [World Health O banization] questionnaire on intermittent claudication, the ankle brachial pressure index, and a reactive hyperemia test. Cigarette smoking was measured by use of a standard- ized questionnaire. In the 561 subjects who had never smoked, 32 (5.7%) had PAD as compared with 12.3% in ex-smokers and 17.8% in current smokers. The never smokers with disease were slightly older and were more likely to be female than the current smokers. They had a higher body mass index, serum cholesterol (non-HDL), HDL cholesterol, systolic and diastolic blood pressure, and glucose intolerance, although a statistically significant difference between never and current smokers was found only for body mass index." "On the basis of self-reported cigarette smoking habits, subjects were classified as current, ex-, or never smokers. Reported passive smoking in the home was examined in the never smokers." "Among never smokers, 32 subjects (5.7%) had PAD. Only 7 of these never smokers with disease reported a history of passive smoking." "The results of this study suggest that individuals with PAD who have never smoked do not have a unique risk factor profile. Also, in the absence of smoking, there is no other factor, such as diabetes mellitus, that would appear to be a prerequisite for the development of disease. Overall, never smokers with PAD had higher levels of most cardiovascular risk factors than current smokers with disease, although the differences were not all statistically • significant, owing perhaps to the small numbers of cases in each smoking category." "A notable difference between never and current smokers with disease was that more of the never smokers were women. This difference was not due simply to more women among never smokers in the whole population, because only 64.2% of healthy never smokers were women compared with 81.2% among diseased never smokers, although this difference was not statistically significant. These results suggest that, among never smokers, women could possibly be more at risk of PAD than men. This may have been partly related to obesity in women because BMI [Body Mass Index] was the factor that showed the most convincing, although nonsignificant, difference in relationships SHB
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• • i NOVEMBER 3, 1995 with disease between never and current smokers. Perhaps other factors that differ between male and female never smokers such as diet may also have been „ important. RE.SPIRATORY DISEASES AND CONDITIONS - CHILDREN [46] "Socioeconomic Status and Indicators of Asthma in Children," P. Ernst, K. Demissie, L. Joseph, U. Locher, and M.R. Becklake, American Journal of Respiratory and Critical Care Medi- cine 152: 570-575, 1995 "The objectives of the present study were (1) to examine the relationship of SES [socioeconomic status] to childhood exercise-induced bronchospasm (EIB) in an area where there is universal access to medical care; (2) to investigate whether the association of SES to EIB or respiratory symptoms could be explained by envi- ronmental factors linked to SES, such as exposure to environmental tobacco smoke exposure (ETS) [sic], heating and cooking fuel used in the home, presence of pets, asthma in a parent, daycare attendance, and reported history of lower respiratory infection (LRI) up to 2 [years] of age." "A questionnaire on respiratory symptoms and history of the child was completed by parents.... The child's exposure to environmental tobacco smoke both in utero (maternal smoking during pregnancy) and postnatally was also assessed, and an attempt was made to quantify current smoking exposure by inquiring about the number of smokers in the home and the average number of cigarettes smoked per day at home (household ETS)." "Non-Caucasian children were more likely to have come from disadvantaged families with low levels of parental education and with crowding, whereas Caucasian children were more likely to have come from homes with higher levels of ETS exposure and [that were] more likely to contain pets." "The analysis of the relationship of potential indica- tors of asthma to SES revealed low SES to be associated with a greater likelihood of the report of night cough or cough with mucus but not of wheeze (whether ever or current) or a history of doctor-diagnosed asthma. EIB was detected more frequently among the less advantaged children." "We investigated further if the observed relationship of SES to both EIB and respiratory symptoms could be explained by the following factors: maternal smoking during pregnancy, household ETS, type of heating and cooking fuel used at home, current presence of a cat in the home, child's daycare atten- dance, crowding, a history of LRI [lower respiratory infection] before 2[years] of age, and single-parent family status. The effect of low SES on EIB or respiratory symptoms persisted even after these variables were included in a model with SES, either one at a time or simultaneously." "EIB was not found to be associated with either maternal smoking during pregnancy or current house- hold ETS exposure. Similarly, there was no association of EIB to daycare attendance or the report of asthma in a parent. On the other hand, the presence of a cat in the home and LRI in the first 2[years] of life were associated with a high likelihood of having EIB. LRI was also associated with ever wheeze (adjusted O.R.: 2.69, 95% CI: 1.63 to 4.42), night cough (adjusted O.R.: 2.13, 95% CI: 1.31 to 3.48), cough with mucus (adjusted O.R.: 2.35, 95% CI: 1.24 to 4.46), and a history of diagnosed asthma (adjusted O.R.: 2.65, 95% CI: 1.69 to 4.15) after accounting for maternal smok- ing during pregnancy, household ETS exposure, age, gender, race, asthma in a parent, presence of a cat, type of heating used in the home, daycare attendance, and SES." "In this cross-sectional study of school children principally 6 to 12 [years] of age, lower SES was associated with an increased likelihood of EIB, night cough, or cough with mucus but not of wheeze or a history of doctor-diagnosed asthma. We also found LRI before 2 [years] of age to be associated with EIB, respiratory symptoms, and a history of doctor-diag- nosed asthma whereas the presence of a cat in the home was associated with EIB but not with symptoms or the diagnosis of asthma." "The social class gradient in EIB and respiratory symptoms could not be explained by differences in other known environmental and host factors (maternal SHB
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B-6 smoking during pregnancy, household ETS exposure, type of heating and cooking fuel used at home, current presence of a cat, child's daycare attendance, reported history of LRI before 2 [years] of age, asthma in a parent, crowding, and single-parent homes). This may be due to inaccuracies in the measures of these factors or, alternatively, that other factors linked to SES are responsible for the increase in EIB and symptoms." "Several studies have now described an association between ETS and BHR [bronchial hyperresponsiveness], including a recent report on EIB. We were unable to demonstrate this relationship in our population. While this may be due to a lack of effect of ETS on_BHR in our study population, it could also result from misclassification of exposure and selection bias according to ETS. This may have occurred if parents who smoked were less likely to give permission to study their children, though this did not appear to be the case in our study population." "The present results provide evidence suggesting that SES is an important risk factor for EIB and respiratory symptoms that are suggestive of asthma. This further suggests that excess morbidity and mortality from asthma in inner-city areas of large American cities is not only due to differential access to health care but that environmental factors associated with social disadvantage are important. Further research into what these factors might be is needed. In the meantime, public policy changes must also be advocated to improve the health status of poor children." REPRODUCTIVE AND DEVELOPMENTA_L ISSUES [47] "SIDS Epidemiology and Incidence," T. Dwyer and A.L. Ponsonby, Pediatric Annals 24: 350- 356, 1995 "[T]he diagnosis of SIDS remains one of exclusion. "The most striking recent development in the epidemiology of SIDS has been the approximately 50% decline in the incidence of SIDS in various ETSlrAQ REPORT, ISSUE 110 "An association between lower socioeconomic status and SIDS has been documented in many studies. The independent contribution of poverty after adjustment for factors such as maternal age, parity, bottle feeding, and smoking remains to be fully assessed." "Maternal smoking during pregnancy is associated with SIDS. A dose response relationship for maternal smoking and SIDS risk has been demonstrated. It is thought that part of maternal smoking's effect on SIDS may be operating through intrauterine growth retarda- tion of the infant. However, a residual association of maternal smoking with SIDS remains after adjustment for birth-weight, suggesting that other pathways such as passive inhalation of smoke postnatally also may be involved. Maternal smoking modifies the relation between maternal anemia and SIDS." "The association between prenatal smoking and SIDS has been mentioned previously. Consistent evidence for an association between postnatal maternal smoking and SIDS also has been obtained from studies of both retrospective and prospective design. The odds ratios observed have generally been_ high, exceeding three in some studies. In those studies where concurrent measurement of other known risk factors has been undertaken, smoking has appeared to be second only in importance to prone sleeping position. In addition, the association is biologically plausible. Infants of parents who smoke have higher hospital admission rates for lower respiratory infection, and respiratory virus infection frequently is found in SIDS infants. Nonetheless, there are still questions about the causal role of postnatal smoking. Most importantly, it has been difficult to separate its effect from that of prenatal smoking as in the studies reported only a small percentage of mothers smoked exclusively either pre- or postnatally." "Without further evidence, it is still not possible to determine how important smoking by other family members is to SIDS. At this stage, postnatal smoking does appear to increase an infant's risk of SIDS even after adjustment for confounding factors such as socioeconomic status, and parents should be instructed not to smoke near their baby or better still, not to smoke at all." ), countries following intervention to reduce the preva- lence of the prone sleeping position during infancy." "The large fall in SIDS incidence following the interventions to lower the prevalence of prone position SHB
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• • • NOVEMBER 3, 1995 have confirmed the fact that prone position is part of the principal causal pathway to SIDS in many commu- nities, being responsible for more than half of the deaths in a number of locations. The recognition of this fact should lead to some change in the balance of current research. The imperative now is to obtain more information on the pathophysiological mecha- nism that explains the effect of prone position. Already there is some evidence that rebreathing of carbon dioxide-rich air, overheating, or airway obstruction could lead to death, and that prone position would make each of these mechanisms more likely to occur. However, the evidence is insufficient to confirm any of these as all or part of the explana- tion. Pathophysiological work in laboratory settings is required to advance knowledge further." "There is also a need to explain those deaths that are due to causes quite separate from prone position. It is likely that parental smoking will account for a substan- tial proportion of the remaining deaths. Some of the others will be due to less common factors impacting on vulnerable infants who have demonstrated other signs of poor general development and of ill health. If action were taken to reduce the prevalence of readily prevent- able causes, it is likely that an annual rate of 0.5 SIDS deaths per 1000 live births could be achieved in many societies, including the United States." [48] "Functional and Developmental Studies of the Peripheral Arterial Chemoreceptors in Rat: Effects of Nicotine and Possible Relation to Sudden Infant Death Syndrome," H. Holgert, T. Hokfelt, T. Hertzberg, and H. Lagercrantz, Proceedings of the National Acaderny of Sciences USA 92: 7575-7579, 1995 "Epidemiological studies have shown a dose- dependent relationship between maternal smoking and sudden infant death syndrome (SIDS). However, no clear mechanism(s) explaining this relation has been identified." "The drive on respiration mediated by the peripheral arterial chemoreceptors was assessed by the hyperoxic test in 3-day-old rat pups." "Attenuation of the hypoxic defense could affect the ability to overcome an apnea-hypoxic episode. This may increase the risk for SIDS - e.g., by interference B-7 with other chemoreElexes.... Corroborating this idea is the finding that some infants who have suffered from chronic lung disease, a group of children that are at high risk of dying of SIDS, show a depressed hyperoxic response." "The infant of a smoking mother has not only been continuously exposed to high concentrations of nicotine in zrtero via the placenta but is also exposed to nicotine after birth via the breast milk. Therefore, it is possible that nicotine from smoking, in addition to acutely attenuating the hypoxic drive, may also inter- fere with the normal postnatal resetting of the peripheral arterial chemoreceptors in humans.... This occurs during a critical developmental period when a decreased dopaminergic activity in the carotid bodies is assumed to be crucial for normal development of the peripheral arterial chemoreceptor function. An insuffi- cient resetting may lead to attenuation of the sensitivity of the peripheral arterial chemoreceptors; i.e., they respond at lower oxygen levels and may put the infant in a critical situation with risk for long and severe hypoxic episodes. We suggest that interference by nicotine with the postnatal resetting of these receptors may be a second mechanism relating maternal smoking to SIDS. It should be mentioned, however, that in addition to nicotine, cigarette smoke contains also other potent substances such as tar and CO. These compounds were not studied here but may well affect the respiratory control, especially in the infant and may influence the development and function of the periph- eral arterial chemoreceptors by mechanisms in addition to the ones found here." "In conclusion, our findings suggest ... that nicotine (from smoking) induces release and synthesis of carotid body DA [dopamine] which acts on local DA2Rs [dopamine type 2 receptors], leading to inhibition of the hypoxic drive. The present data also suggest that nicotine may interfere with the postnatal resetting of these receptors. Thus, two possible mechanisms are proposed by which nicotine from smoking may interfere with the frrst line of defense against hypoxia and may lead to SIDS, either alone or by interference with other reflexes." SHB 00
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B-8 OTHER HEALTH ISSUES [49] "Risk Factors for a First Febrile Seizure: A Matched Case-Control Study," A.T. Berg, S. Shinnar, E.D. Shapiro, M.E. Salomon, E.F. Crain, and W.A. Hauser, Epilepsia 36: 334- 341, 1995 "Febrile seizures are the most common type of seizure and occur in 2-5% of all children in the United States and in Western Europe.... We conducted a matched case-control study to identify risk factors for a first febrile seizure, with special emphasis on the characteris- tics of the acute illness episode. Study factors included the height of temperature, diagnosis, use of acetami- nophen or other medications, family history of febrile seizures and of epilepsy, as well as several other factors that have been linked previously to febrile seizures." "Cases=had higher maximum temperatures than controls....[T]he risk of having a febrile seizure nearly doubled with each increase in degree Fahrenheit above 101 °." "Seventeen (25%) of cases and 5 (5%) of controls had at least one first-degree relative (i.e., parent or full sibling) with a history of febrile seizures (mOR [matched odds ratio] = 7.4, 95% CI 2.1, 25.7)." "Because previous reports have linked maternal smoking during pregnancy to febrile seizures, and other reports have linked passive smoking to illness in young children, we examined the association between febrile seizures and both maternal smoking during pregnancy and current exposure to passive smoke in the home. Univariate analysis showed cases to be more likely than controls to be exposed to passive smoking prenatally (mOR = 2.7, 9 5 % CI 1.2, 6.2). Further- more, a significant univariate trend was noted when the amount of smoking was categorized (0, occasional <1/day, 1-5, 6-10, 11-20, and >20 cigarettes/day) with an mOR of 1.5 (95% CI 1.1, 2.1) for each incremental increase in category of cigarettes per day. There was no such association for exposure to any passive smoke in the home at the time of entry into the study (mOR 1.3, 95% CI 0.6, 2.4)." "Our most notable finding was the progressive increase in risk of a febrile seizure with increasing height of temperature, particularly because controls ETS/IAQ REPORT, ISSUE 1_ 10_ ___ were selected in such a way that they may have had more serious illnesses than did cases." "Our findings provide direct evidence confirming the role of height of temperature in children who had illnesses representative of those typically associated with febrile seizures." "The primary differences between cases and controls with respect to their underlying illnesses was the higher proportion of controls with gastroenteritis evident after we adjusted for temperature." "Family history of febrile seizures most likely repre- sents a genetic susceptibility to seizures with fever. Although a more general susceptibility to all seizures may exist, the negligible association with a family history of epilepsy after adjustment was made for family history of febrile seizures suggested that the effect may be specific to febrile seizures." "The findings regarding maternal smoking during pregnancy are difficult to interpret. Two larger studies have already reported a significant dose-response association between smoking during pregnancy and febrile seizures. In one of these studies, investigators were able to control for current exposure to passive smoke in the home, a well-documented risk factor for illnesses in young children; smoking during pregnancy but not current exposure to passive smoke was associ- ated with febrile seizures.... Although in the multivariable model, in utero exposure to cigarette smoke was only marginally significant, the magnitude of the association was similar to that in the univariate analyses both for any maternal smoking and for the amount of maternal smoking during pregnancy, which suggests addition of the other factors in the model caused a loss ..- in precision rather than that the association with smoking was due to confounding by any of the other variables retained in the model." "The lack of association in our study between daycare attendance and febrile seizures may be due to use of controls who were already ill. Presumably, illness is a major pathway for the association between daycare attendance and febrile seizures, since children who attend daycare develop illnesses more frequently and illness is a necessary condition for a febrile seizure." "Febrile seizures are a common childhood problem. Although they are now recognized as a benign syn- SHB .
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• • • NOVEMBER 3, 1995 drome determined largely by genetic factors, they are the prime example of the developing brain's suscepti- biliry to seizures and its ability to outgrow this susceptibility. Therefore, better understanding of what causes febrile seizures is still important. Our results demonstrated several associations, particularly the importance of degree of fever, and also suggest that the risk of a febrile seizure may vary as a function of the type of underlying illness. We provide further evidence regarding the role of smoking during pregnancy and confirm the associations with family history of febrile seizures." [50] "Relation Between Passive Tobacco Smoke Exposure and the Development of Bacterial Meningitis in Children," R.C. Bredfeldt, S.R. Cain, G.E. Schutze, T.M. Holmes, and L.A. McGhee, Journal ofAmerican Board ofFamily Practice 8: 95-98, 1995 "Despite the growing list of childhood illnesses associated with passive cigarette smoke exposure, the medical literature is silent about the effect, if any, cigarette smoke might have on the development of bacterial meningitis in children. Only one report from Europe in 1982 raised the question of a possible link between passive tobacco smoke exposure and meningi- tis. Haneberg and associates noted that passive smoke exposure was more common among 115 children with symptomatic meningococcal disease than in a control population. The purpose of this study was to investi- gate further whether a link exists between passive exposure to cigarette smoke and the development of bacterial meningitis in children." "Telephone contact was made after persistent efforts for a total of 73 meningitis cases and 74 control cases. . . Forry-five children who had bacterial meningitis had a history of exposure to passive cigarette smoke either in the home or in a day-care setting. In comparison, 30 children similarly exposed were admitted for abdomi- nal surgery. This increased exposure to cigarette smoke among children admitted for bacterial meningitis was also seen when household exposure only was analyzed." "The results of this investigation indicate that passive exposure to cigarette smoke is associated with increased risk of bacterial meningitis in children. The mechanism by which passive cigarette exposure might increase this risk is one of conjecture. Further studies could be B-9 undertaken both to confirm these results and to clarify the mechanism of this phenomenon. Several studies have suggested that cigarette smokers tend to have depressed immune systems. One could theorize that those exposed to passive cigarette smoke could be similarly affected. Cigarette smoke might also have an adverse effect on local defense mechanisms in the____ _ nasopharynx. Smokers have been shown to carry Neisseria meningitides longer in the nasopharynx than nonsmokers. The results of our study might, therefore, simply reflect a longer exposure time to the infecting organism in the nasopharynx of children exposed to passive tobacco smoke." "Perhaps the greatest criticism of this work is that the study relied on caregiver recall, sometimes of events several years past. Obviously this bias should have affected both the control and study group similarly. Thus, this bias should not necessarily have had a major effect on the results." "Another potential criticism could be that the control group was matched by age and sex, but not specifically by socioeconomic status. It is conceivable that children of a lesser socioeconomic status, for example, might be more prone to the development of bacterial meningitis and might independently be more likely to be exposed to passive cigarette smoke. That essentially no differ- ence existed between the study group and the control group in hospital reimbursement methods gives indirect evidence that there was no significant differ- ence in the socioeconomic status of these groups." "Despite these potential criticisms, the results of this study indicate that bacterial meningitis is more likely to develop in children exposed to passive cigarette smoke than in those who are not so exposed. Consider- ing the potentially devastating complications of this disease, this information needs to be confirmed and shared with childhood caregivers." [51] "Involuntary Smoking and Children's Health," J.M. Samet, E.M. Lewit, and K.E. Warner, Current Problems in Pediatrics 25(6): 189-204, 1995 "This review considers the effects of involuntary exposures to tobacco smoke on_ the health of children.__ These exposures occur to the unborn child as compo- nents of tobacco smoke cross the placenta to the fetal SHB
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B-10 circulation and after birth as the child breathes to- bacco-smoke contaminated air at home, in vehicles, and in public places.... In considering approaches for minimizing the exposure of children to tobacco smoke, we emphasize the lessons that have been learned in reducing active smoking and controlling tobacco smoking in public places, and make suggestions for areas where more aggressive actions may be indicated." "[C] ritics of the findings of adverse effects of smoking on health have attempted to dismiss epidemiologic research as observational and, therefore, unable to establish cause-effect relationships.... As the data on involuntary smoking and child health have accumu- lated during the past 20 years, adverse effects have been found consistently with different investigational approaches and in different countries. This consis- tency along with demonstration of dose-response relationships between measures of exposure and health effects strengthen arguments that the observed associations are causal." "Epidemiological investigations conducted through- out the world have linked involuntary smoking by infants and young children to increased occurrence of lower respiratory tract illnesses, such as bronchitis, bronchiolitis, and pneumonia. ETS exposure is thought to increase risk for infection by respiratory pathogens, primarily viruses, rather than to cause illness by a direct toxic effect of the lung." "Although involuntary exposure to tobacco smoke is associated with the symptom of wheeze, evidence for association of involuntary smoking with onset of child- hood asthma has not been consistent in the literature.... The inconsistencies in the literature cannot be readily explained, and the EPA risk assessment concluded that ETS is a risk factor for asthma but stopped short of characterizing the relationship as causal." "While involuntary exposure to tobacco smoke has not been established as a cause of asthma, there is strong evidence that involuntary smoking worsens the condition of those with asthma." "The reduced lung growth associated with involun- tary smoking represents an apparently permanent effect; its permanency and associated reduction of the lung's reserve as the child enters adulthood could offer a strong deterrent to parents' smoking, if convincingly shown to parents." ETS/IAQ REPORT, ISSUE 110 "Eliminating or significantly reducing the adverse effects of involuntary smoking on children requires a multifaceted strategy that addresses exposure in utero and after birth, in the home and outside the home. Three types of strategies can be identified, each with favorable impact on child health: broad programs for smoking prevention and cessation; initiatives to reduce exposures to ETS generally, and policies to specifically limit children's exposure to tobacco smoke. We focus on the last set of strategies, acknowledging that sub- stantial effort is currently directed at reducing active smoking and at controlling ETS exposure in public, commercial, and workplace environments." "One conceptually easy but politically difficult action would be to include a warning on the danger to children of ETS exposure on cigarette packages as is done in other countries." "The true 'frontier' of smoking control, and perhaps one of the most important determinants of the health damage wrought by ETS, is how society will deal in the future with parents' smoking in the presence of their children. Given the sanctity of the home, this most important locus of ETS exposure remains the one least likely to be drawn significantly into the battle. Recent court actions indicate that the home front will not remain exempt from attention. The practical challenge, however, is to develop educational interventions that are at once effective and noncoercive." ETS EXPOSURE AND IVIONITORING [52] "Are Self-Reports of Smoking Rate Biased? Evidence from the Second National Health and Nutrition Examination Survey," R.C. Klesges, M. Debon, and J.W. Ray, Journal of Clinical Epiderniology48: 1225-1233, 1995 "Most medical and epidemiological studies linking cigarette smoking with cardiovascular and other health risk factors have typically relied on self-reported estimates of both subjects' smoking status (whether or not they were current smokers) and the number of cigarettes smoked per day to determine the health consequences of smoking. The presumption is that self-reports of smoking behavior represent a reasonably SHB
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• • • NOVEMBER 3, 1995 accurate measure of smoking exposure. This assump- tion, however, has been recently questioned. For example, some reviews have hypothesized that smokers may consciously either (1) misreport the number of cigarettes consumed (e.g. round number to the nearest half-pack); (2) fail to accurately recognize their true exposure to smoking; or (3) may consciously minimize their actual cigarette use in response to the social stigmas associated with smoking or as a result of experimental demand to report smoking cessation." "Given the uncertainty in the literature, the purpose of the current investigation is to evaluate, on a large- scale basis, the degree and magnitude of digit preference in a large sample drawn from the Second National Health and Nutrition Examination Survey (NHANES II). Degree of 'digit bias' will then be compared to COHb [carboxyhemoglobin] levels, a highly reliable measure of smoking exposure collected on the same individuals. Finally, the characteristics of those individuals (e.g. males vs females) reporting smoking in multiples of ten will be compared." "The results suggesting a large percentage of smokers reporting intake in multiples of 10, along with no concomitant evidence of spikes in the distribution of COHb, may indicate that smokers engage in a consid- erable amount of digit bias; either 'rounding up' or `rounding down' to the nearest multiple of ten. These data are consistent with other studies that have con- cluded that, due to the manner by which subjects regulate their intake, numerical rankings of number per day (e.g. 10, 11, 12 ...) are too inaccurate to be used. This may explain, at least in part, the consis- tently low (but significant) relationships between selE reports of smoking behavior and objective indices of smoking exposure. It may also help to partially explain the variable dose-response relationships between self-reports of smoking rate and various behavioral, epidemiological, and physiological correlates of smoking." "The results also indicated that Caucasians, heavier smokers, and those with less education may be particu- larly likely to report a digit preference. It is interesting to_ note that African-American smokers are less likely to report a digit bias. Perhaps this is due to the fact that African-Americans smoke fewer cigarettes per day and perhaps may pay closer attention to the number of cigarettes they smoke in a day.... Heavier smokers °B-II and those with less education were, in contrast, more likely to report a digit preference. Collectively, the implication of this finding is that it may be relatively more difficult to obtain valid self-reports of smoking in particular segments of the adult population (e.g. a Caucasian male with little formal education)." "Since (a) we did not directly observe cigarette intake, or compare a global self-report to more direct measures of intake (e.g. the collection of cigarette butts, self- monitoring of intake); (b) COHb has a relatively short half-life; and (c) smokers may vary their intake from day to day, we cannot positively rule out that smokers are not smoking in these `round digit' amounts. The fact that most cigarettes come 20 ci,arettes to the pack may be one reason why we observed such a`peak' at 20 reported cigarettes per day. However, the most plau- sible explanation, given our data and data reported elsewhere, is that digit bias is more likely to account for the observed findings. For example, it does not appear plausible that 71% of the adult population smoke precisely 20 cigarettes per day without observing some type of concomitant peak on COHb." "Assuming that subjects are rounding up or down their smoking intake, another question left unanswered is whether the digit preference is systematic or random. ... Given that a systematic bias would be much more problematic than a random one, future studies should _ focus on the nature of the self-report bias." "In summary, smokers tend to self-report in multiples of 10, and there is evidence that this may be due to either a systematic or random digit preference." GENOTOXICITY AND MUTAGENICITY [53] "Genetic-Environmental Interactions and Low- Level Exposure to Carcinogens," P. Vineis and T. Martone, Epiderniology 6: 455-457, 1995 "According to the causal theory,... causes in and of themselves do not have to be necessary andJor suffi- cient, but each single cause may contribute to a 'sufficient causal complex.' For example, smoking in itself is certainly a`cause' of lung cancer in that it increases the risk considerably, but it is neither a SHB
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B-12 necessary nor a sufficient cause. Rather, it may contrib- ute to a causal complex together with other contributing factors. One of these factors may be genetic predisposition ... An important characteristic of genetically based metabolic polymorphism is that it requires exposure to chemical agents to be effective, that is, it represents a typical example of 'complete interaction' (the genetic trait in itself is ineffective in the absence of exposure). A second characteristic is its `atemporality': in contrast with external exposure, genetic predisposition does not vary over time." "Low-level exposure to carcinogenic chemicals is a frequent, if not ubiquitous, occurrence in western countries. Environmental tobacco smoke and, possibly, vehicle exhaust are widespread sources of polycyclic aromatic hydrocarbons, 4-aminobiphenyl, and other carcinogens in nonsmokers." "The hypothesis of genetic susceptibility at low doses is consistent with early work on arylamine- induced bladder cancer, which showed that, under exceptional exposure conditions (very high levels of exposure), individual susceptibility was irrelevant. In fact, in a plant where workers were engaged in 2- napthylamine manufacturing, 15/15 (100%) developed bladder cancer." "The same hypothesis might be a valid explanation of interethnic and geographic variation in incidence rates for cancer, which are not entirely explained by the known risk factors. In addition, it could explain why extrapolation from high doses fails to give risk esti- mates that correspond to cancer incidence observed at low doses. For example, exposure to environmental tobacco smoke occurs at levels much lower than those associated with active exposure, but risk actually found is higher than would be expected on the basis of linear extrapolation. If the population includes a subgroup with genetically based susceptibility, however, strict proportionality to dose would not be necessary. All of these implications make the study of genetic-environ- mental interactions an issue critical to future epidemiologic research." "Only a small proportion of cancer causation is explained by simple monogenic inheritance. Polygenic inheritance that increases metabolic susceptibility to carcinogens may play an important role. Epidemiologic studies indicate that metabolic polymorphisms are ETS/IAQ REPORT, ISSUE 1 10 associated with a higher risk of cancer after exposure to carcinogens, and that this kind of genetic susceptibility may have a greater effect among those exposed to low levels of carcinogens. The implications of greater genetic susceptibility to ubiquitous low-level exposures deserve consideration by epidemiologists. For example, the shape of the dose-response relation after exposure to environmental pollutants such as environmental tobacco smoke may be influenced by such low-dose susceptibility." INDOOR AIR Q-UALITY [54] "Possible Mechanisms for the Respiratory Tract Effects of Noncarcinogenic Indoor-Climate Pollutants and Bases for Their Risk Assess- ment," G.D. Nielsen, Y. Alarie, O.M. Poulsen, and B.A. Nexo, Scandinavian Journal of Work and Environmental Health 21: 165-178, 1995 "This review ... deals with the possible mechanisms of the direct effects of indoor climate pollutants on the lower respiratory tract and risk assessment aspects. We propose that preliminary risk assessment of indoor-air pollutants be based on existing occupational exposure limits (OEL)." "Only a limited number of exposures and substances in indoor air [are] known to cause pulmonary effects. (Asthma has been dealt with in a separate section.)" "Overall, some main points appear in relation to normal indoor-air exposures that in general are far below occupational exposures. The application of concentration response relationships suggests that effects caused by indoor-air exposures will also occur at higher exposures in occupational settings or in animal studies. As the indoor-air effects are generally more subtle, it can be expected that only the most sensitive systems of the lungs will react. These systems are the cells involved in the specific cellular and humoral immune responses (discussed in the section on asthma), the macrophages, the epithelial cells, and the sensory nerves in the lungs." "The fact that asthmatics are sensitive to environmen- tal irritants is suggested by the effect of environmental SHB • •
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• • • NOVEMBER 3, 1995 tobacco smoke. The intensity of the symptoms cough, headache, and chest tightness was significantly greater in asthmatics than in nonasthmatics. However, asth- matics only reported intensities from less than 'trace' to less than 'minimal.' The prominent symptoms were unpleasant odor (rated from 'moderate' to 'severe'), eye irritation (about 'moderate' to 'severe') and nasal discharge (about 'trace' to 'minimal'); the levels were not significantly different from the levels in nonasthmatics. A higher response in asthmatics may be due to an increase in airway hyperactivity or to fear of a smoking environment. A recent review on environ- mental tobacco smoke generally reached the same type of conclusion." "In toxicology, extrapolation from high- to low-dose responses has always been a problematic task. It includes extrapolation from effects at occupational exposure levels to effects at indoor-climate levels. A scientifically sound approach can be applied if Harber's Law is obeyed. It states that the effect is determined by the cumulative dose, determined by the product of the concentration and the exposure time." "Only a few of the potentially sensitive groups are believed to be of practical importance. The increased sensitivity of children has not been found to be excessive and may therefore be handled through the use of a small safety factor in risk assessments. Subjects with alpha-l-antitrypsin deficiency should be protected from indoor-air concentrations of substances with inflammatory effects. On the other hand, it will probably not be possible to protect all asthmatics, as even a pure odor response may trigger an asthma reaction. Nevertheless, experiences of occupational exposure effects, including exposure limit documenta- tion, combined with Harber's Law and the additivity concept, may clearly be very valuable in the estimation of lung effects of indoor-air pollutants." "A major problem arises when some specific sub- stances are used as indicator substances for potentially harmful mixtures, especially for ozone, nitrogen dioxide, and particulate matter. In such cases definite indoor-air exposure limits should be established." "[I]n relation to asthma, risk assessment should focus on data on the sensitization process rather than on possible exaggerated bronchoconstrictive response to nonreactive organic chemicals generally present indoors." B-13 "Tobacco smoke is a strong irritant and can serve as an adjuvant. Thus exposure to environmental tobacco smoke is significantly associated with the development of asthma." "Occupational exposures constitute the most exten- sive collection of data on asthma due to low molecular-weight compounds. Sensitization to these compounds seems to be less influenced by atopy and adjuvant effects. Industrial air is also in general more polluted than indoor-air in, for example, office build- ings and private houses. Consequently, the adjuvant effects may well be less in nonindustrialized settings." "There are two main groups of chemosensitive lung receptors, the rapidly-adapting stretch receptors ('irritant receptors') and the C-fiber receptors.... Irritant receptors are stimulated by airborne substances (e.g., ammonia, sulfur dioxide, ether, and cigarette smoke) and by endogenous mediators." "Symptoms from the lungs are relevant in relation to indoor-air exposures. Thus cough, wheezing, and a high frequency of airway infections are among the characteristic Findings of the sick-building syndrome." "Experience with exposure-related sensations from the lungs can be obtained from controlled chamber experiments, from exposure to outdoor pollutants, and occupational exposures. Typically, the outdoor pollut- ants ... comprise a limited number of substances and indicator substances.... Thus an extensive data base on exposure-related lung sensations cannot be estab- lished for any of these exposures. Experience with occupational exposures, irrespective of all the limita- tions of these data, furnish[es] information on a broader range of substances." "Concentration-effect relationships apply to toxic effects, sensitization, and neurogenic effects of the lungs. No-effect levels are also believed to exist. For toxic and sensitization effects, Harber's Law seems to overestimate the low-dose risk if extrapolated from a high exposure level." "Clearly, it would be desirable to use indoor-air standards in combination with methods evaluating the ~ interplay between substances in mixtures in assess- C~ ments of indoor-air health effects." ~ "Many hundreds of occupational exposure limits and documentation for them exist. Thus there would be a SHB
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B-14 tremendous saving of human and financial resources if the selection of a safe indoor-air level would start by considering these limits, an approach taken in this review. Using Harber's Law and accepting that the exposure limits are for 8 [hours] a day, 5 [days] a week, the indoor exposure level should not exceed [approxi- mately 1/4 OEL]. In general, the working population may not include the particularly sensitive groups at increased risk. This review has indicated that the more susceptible individuals may not be that much more sensitive, except for the already sensitized or allergic subjects and for subjects with a profound alpha-l- antitrypsin deficiency. For other groups at increased risk protection can be achieved with a common safety factor, often set at 10, in the standard setting proce- dure. Thus a preliminary indoor-air guideline for lung effects would be equal to 1/40 OEL. If none of the indoor-air substances exceed these concentrations, the substances themselves are not believed to cause health effects. If one or more concentrations fall into the `gray' range (i.e., from 1/40 OEL to 1/4 OEL), a detailed evaluation should be carried out. Except for the sensitization effects of allergens, the effects of indoor-air mixtures of substances with the same biological effect should be considered additive, as is the case for occupational exposures." "In conclusion, the suggested approach in which occupational exposure limits are used in a preliminary risk assessment of indoor-air concentrations may be advantageous for several reasons: it is simple, it is based on a limited number of assumptions, it has a transpar- ent biological foundation, and it is based on existing toxicologic documentation for occupational exposure limits. This approach may save resources and time in the evaluation of the direct health effects of indoor air." [55] "Air Nicotine and Saliva Cotinine as Indicators of Workplace Passive Smoking Exposure and Risk," J.L. Repace, J. Jinot, and S. Bayard, manuscript submitted for publication, available to the public as Exhibit 340-1753 in OSHA Docket H-122 "The tobacco industry, which has a vital economic stake in the outcome of this [OSHA] rulemaking, asserts that exposures to ETS in the workplace - and thus the risks from passive smoking - are insignifi- cant, and therefore beneath regulatory concern. ETS/IAQ REPORT, ISSUE 110 Therefore, assessing the distribution of ETS exposures in U.S. workplaces is important." "The purpose of this paper is (1) to develop a steady- state physical model to predict nicotine exposure from workplace smoking; (2) to develop a pharmacokinetic model to relate nicotine exposure from passive smoking to a nonsmoker's dose of salivary cotinine, so that salivary cotinine (as well as plasma and urinary cotinine) levels due to passive smoking might be traced directly to the primary determinants [of] workplace exposure: duration of exposure, smoker density, and air exchange rate: (3) to use a monte-carlo (probabilistic) analysis to develop estimates of the shape of the exposure and dose distributions, and (4) to compare the predictions of the monte carlo model to studies of the observed salivary cotinine distribution of workers exposed to ETS only at work, and to the observed distribution of nicotine in workplace air." "Such a probabilistic physico-pharmacokinetic model permits determination of the distribution of ETS workplace exposures and doses for the best available atmospheric and biomarkers, as well as estimation of the lifetime lung cancer risk from chronic passive smoking as a function of the average workplace occupancy, smoking prevalence, volume, and air exchange rate. Further, such a model permits assess- ment of the uncertainty surrounding the measures of central tendency introduced by variations in the physical and biological determinants of exposure and dose. This would aid regulators in assessing both the significance of workplace risk from passive smoking, as well as appropriate control measures, and would aid epidemiologists seeking to improve estimates of exposure and response in studies of passive smoking and its diseases." "[F]or a single compartment, in the steady state, the average ETS concentration to which nonsmokers are exposed will be directly proportional to the smoker density and inversely proportional to the air exchange rate." "During the 1980's, a number of workers found that averaged over time, ETS nicotine occurs in an approxi- mate ratio of 1:10 to ETS-RSp. Thus models designed for the prediction of ETS-RSP are easily adapted to the estimation of nicotine concentrations.... Because for many nonsmokers exposure to ETS is regularly experi- SHB .
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• • • NOVEMBER 3, 1995 enced at home and at work, and because nearly 90% of a person's time is spent in these two microenviron- ments, a steady-state model is appropriate. Cotinine as a biomarker provides a valid and quantitative measure of average ETS exposure over time....[S]alivary cotinine is proportional to the duration of ETS exposure, which in turn is determined by the smoker density and air exchange rate of the building." "ETS nicotine emissions can be estimated from this model ... Data comparing ETS-RSP emissions to ETS-nicotine emissions for the top 50 U.S. cigarette brands, representing 64% of the U.S. market, was [sic] submitted to the OSHA Indoor Air docket by RJ Reynolds (RJR).... An average of the three values for nicotine emission is 1.8 mg/cig., close to the value calculated from the RJR data. For our purposes, we shall use the RJR data for cigarette nicotine emissions." "[S]alivary cotinine is seen to depend primarily and linearly upon exposure duration and ETS nicotine concentration during exposure." "[S]alivary cotinine is directly proportional to the number of smokers and inversely proportional to the air exchange rate and exposure space volume." "It is of interest to apply [equations from the model] to the case of the office workplace to generate point estimates of the mean values for the nicotine concen- tration, N, in a typical U.S. office workplace and the mean salivary cotinine concentration, S, for a typical nonsmoking worker in that workplace." "As the monte carlo simulation shows, use of a dichotomous variable ' exposed' or ' unexposed,' the norm in the epidemiology of passive smoking oversim- plifies reality." "The results show that the model in point-estimate form generates an estimated mean value for nicotine within 12% of the mean value found for 61 measure- ments in offices in 9 worksites in Massachusetts. For salivary cotinine, the model in point-estimate form generates an estimated mean value for cotinine in all subjects which is within 5% of that found in 186 resfdents of Rhode Island. In probabilistic form, the model is able to explain the shape of the observed exposure distribution of nicotine in the Massachusetts workplace air, and that of the dose distribution of salivary cotinine in the Rhode Island workers. This B-15 suggests that the models we have developed for nico- tine and cotinine incorporate all the necessary parameters for their prediction. The range and uncer- tainty in the parameters is adequate to generate the distributions to within a reasonable approximation." "The reasonable agreement of theory with observa- tions for both nicotine and cotinine suggests that the model parameters as chosen are sufficient to explain the effect of uncertainties introduced by physical differences among workplaces, sociological differences in exposure patterns, and biological differences among subjects." "Based upon the ETS nicotine risk model of Repace and Lowrey, a workplace ETS nicotine concentration of 7.5 ug/m3 corresponds to a 1/1000 risk for 40 years' exposure. Adjusting this to the 45 year period used by OSHA, a 45-yr average nicotine concentration Nrig = 6.7 ug/m3 would correspond to a 1/1000 'significant risk' as designated by OSHA. From the percentile distribution generated by the monte carlo analysis, it appears that approximately 65% of nonsmoking workers in office workplaces with unrestricted smoking will be exposed to nicotine levels above 6.7 ug/ m3,corresponding to OSHA's 'significant risk' level of 1 per 1000, and that 10% of workers in an off ce workplace with unrestricted smoking are exposed to an ETS-nicotine concentration of [greater than or equal to] 24 ug/m3, corresponding to an estimated lifetime lung cancer risk of [approximately] 4 per 1000. By comparison, levels of a'e minimis risk for environmental pollutants for large populations are typically of the order of I per million." "Assuming that the nonsmoking workers have no exposures to ETS other than at work, the table of percentiles of the cotinine distribution shows that 60% of workers would exceed a 1/ 1000 risk from passive smoking at the office, and that 10% of those workers would have a risk [greater than or equal to] 4 per 1000. On the other hand, if workers have other exposures due to social encounters or a smoker at home, the effect of the workplace exposure would be to place a larger percentage above the 1/ 1000 level." "It appears that in the typical U.S. office workplace, under typical conditions of smoking prevalence, occupancy, and for standard ventilation rates, unre- stricted smoking poses lung cancer risks to nonsmokers SHB
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B-16 which are more than a thousand times acceptable risk levels for environmental carcinogens, and demonstra- bly above the level triggering regulation of occupational carcinogens." STATISTICS AND RISK ASSESSMENT [56] `Heterogeneity in Meta-Analysis of Data From Epidemiologic Studies: A Commentary," G.A. Colditz, E. Burdick, and F. Mosteller, American Journal ofEpidemiology, 142: 371-382, 1995 "Research synthesis of data from epidemiologic studies by using meta-analysis is becoming increasingly common. Between September 1988 (when the Na- tional Library of Medicine added the term ` meta-analysis' to its key words) and September 1993, more than 150 published reports combined results from observational epidemiologic studies. These meta- analyses of observational epidemiologic studies were a subset of a total of about 1,000 meta-analyses identi- fied through a search of the MEDLINE data base. The term heterogeneity characterizes the situation in which differences in study outcomes are not readily accounted for by sampling variation. A review of these meta- analyses indicates that heterogeneity and approaches to dealing with it take many forms, and such diversity may leave the reader uncertain about the interpretation of the combined results.... Epidemiologic studies that appear to be similar in design can vary greatly in results. Then the question arises, When is it acceptable to combine these studies? We review the approaches taken to identify, deal with, and interpret heterogeneity in meta-analyses of epidemiologic data and suggest methods that may be used in future studies." "Many potential sources of heterogeneity occur within epidemiologic research using case-control and cohort designs. Although these may include the heterogeneity of a disease (for example, senile dementia) or its classifi- - cation a_nd publication bias, in this paper we focus on the following three areas when combining results from epidemiologic studies: 1) the design and implementation of studies to be combined; 2) the exposure definition and levels; and 3) the covariates." ETSIIAQ REPORT, ISSUE 110 "[D]ifferent methods to measure exposure and variation in cutpoints across studies provide inherent problems for the meta-analyst working with epidemio- logic data. Heterogeneity among exposure measures is therefore to be expected in a set of epidemiologic studies for meta-analysis. Getting a measure of quality of the method of assessing exposure seems to be an outstanding problem for epidemiology. We look forward to research developments in this area. A difficulty that may persist, however, is that each area of exposure measurement may require its own methodol- ogy for measuring quality." "Among the many goals of meta-analysis are the estimation of an overall association or magnitude of effect and the identification of sources of heterogeneity among the results from the primary studies. Subgroup analyses are one such approach to the understanding of heterogeneity." "It is important to distinguish these two purposes of meta-analysis. When quantifying the magnitude of an association, we are usually addressing a question or hypothesis defined in advance of the analysis. In this situation, established procedures are available to provide confidence statements around an estimated summary measure. On the other hand, when exploring data compiled for a meta-analysis to identify factors that may explain variation among studies, we move to an exploratory data analysis mode and identify vari- ables from those that are available. By using regression approaches to meta-analysis, one may add these variables to the analysis and reduce the unexplained variance. However, because we usually approach identifying sources of variation in an exploratory mode, we do not have the usual statistical methods available to provide confidence statements." "In reviewing meta-analyses of epidemiologic data, we note that assessing and reporting heterogeneity is often ignored, and the assumptions of the fixed effects model are probably not true. Further, excluding studies from meta-analysis because of observed heterogeneity can be dangerous. In this paper, we briefly review several factors contributing to heterogeneity and approaches that may be taken to estimate among-study variance. Such analysis should be undertaken in the spirit of an exploratory data analysis, and inferences must be cautious. Greater attention to heterogeneity and improved reporting of the variance among study results SHB • •
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• • • NOVE?viBER 3, 1995 will help investigators understand exposure disease relations. All meta-analyses of epidemiologic data should report the magnitude of the among-study variance in addition to the methods used to assess it." "By developing a clear set of methodological guide- lines for reviewing prior research and using statistical procedures to summarize the results, meta-analysis offers the potential to make reviewing the literature more of a science than an art. With this added disci- plin_e, disagreements among conclusions should more often be traceable to explicit analytic choices whose effects can be measured. In addition to providing a quantitative summary estimate of results from a body of research, meta-analysis offers a set of techniques to explore conditions under which effects occur. In a meta-analysis, documenting heterogeneity of effect can be as important as reporting averages (or means or location). Heterogeneity may point to situations in which an intervention works and those in which it does not. Such information can be an important consider- ation, although not the only one in policy decisions and the design of subsequent studies." [57] "Invited Commentary: Benefits of Heterogene- ity in Meta-Analysis of Data From Epidemiologic Studies," J.A. Berlin, American Journal ofEpidemiology, 142: 383-387, 1995 "In their commentary in this issue of the journa4 Colditz et al. have made a number of interesting points and raised some equally interesting questions related to heterogeneity in meta-analyses of epidemiologic data. In selecting a tide for this invited commentary, I have chosen to emphasize explicitly the positive aspects of heterogeneity. I would like to complement (and compliment) the material presented by Colditz et al. by expanding on three major areas: 1) meta-analysis, particularly the exploration of heterogeneity, as original research; 2) the use of meta-analysis in the planning of future research; and 3) some potential pitfalls of which one needs to be aware in the exploration of sources of heterogeneity. The important message of my com- ments will be that heterogeneity of study results can provide many benefits and should be viewed as a strength of meta-analysis, not a barrier to its use." "Meta-analysis shares a number of characteristics with so-called primary studies that are traditionally viewed as original research. It has the potential to resolve B-17 conflicting research results in much the same way as a 'definitive' clinical trial or epidemiologic study does. Because it involves comparisons across studies, meta- analysis can lead to insights when study design, exposure assessment or exposure levels, study popula- tions, etc., are found to relate to study outcome. Meta-analysis involves establishing predefined eligibil- iry criteria for data to be included, data collection, and data analytic methods and requires careful interpreta- tion of results with conclusions limited by the available data and study populations. In these regards, it is similar to any other observational study and can provide new information in the same way that a cohort study can. 11 "One consequence of analyzing data at the level of the study, rather than at the level of the individual, is that study-level characteristics are assumed_to apply to all of the members of a study. This principle is similar to the assignment of group-level values for exposure in ecologic studies or the assignment of exposure levels based on broad job categories in occupational epide- miologic studies. This problem can make interpretation of the individual-level question some- what difficult when investigating sources of heterogeneity." "A second concern in exploring sources of heteroge- neiry is that other differences may exist among studies apart from the study characteristic we are examining... .[C]omparisons between types of studies are just as subject to potential bias by unmeasured confounders as are comparisons between exposed and unexposed individuals in any observational study." "The idea that comparisons may be confounded has led several authors to advocate the use of regres- sion models to explore heterogeneity. Regression models could be used to examine the effects of a given study-level variable while controlling for the effects of other variables. Unfortunately, study characteristics are sometimes so highly correlated with each other that it can be difficult to separate the effects of one from another." "[1y1]orking with study-level data presents some challenges that are not faced when analyzing indi- vidual-level data. At the same time, exploration of heterogeneity also faces the same challenges as the analysis of any observational epidemiologic data, in SHB 60
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B-18 ETSIIAQ REPORT, ISSUE 1 10 that issues of confounding, interaction, and model- building strategies require strict attention." "Colditz et al. have presented a wide-ranging discus- sion of many aspects and implications of heterogeneity in meta-analyses of epidemiologic studies. In this paper, I have supplemented their discussion with a few related observations. In general, the two papers point to several main conclusions:" "1) Heterogeneity is common in meta-analyses of epidemiologic data and probably should be viewed as the expectation, rather than the exception. Despite that fact, many authors fail to assess, report, and explore the sources of heterogeneity;" "2) Analyses of heterogeneity should be undertaken, but should be pursued and interpreted cautiously in the spirit of an exploratory data analysis;" "3) The exploration of heterogeneity can lead to insights about modification of apparent associa- tions by various aspects of study design, exposure measurements, and study populations;" "4) Relations discovered in the process of exploring heterogeneity may be useful in the planning and execution of subsequent studies;" "5) The exclusion of outlying results solely on the basis of their disagreement with other studies can lead to seriously biased summary estimates and should be avoided; and" "6) Sources of heterogeneity to be explored are most easily interpreted when they are identified in advance of the analysis, not when they are sug- gested only by the data." "Meta-analysis is like any other form of data analysis in that it requires strict adherence to methodological guidelines, careful planning, the use of a priori definitions and analytic strategies, and extremely careful interpretation that does not go beyond the limits of the data." • SHB
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• NOVEMBER 3, 1995 APPENDIX C UPCOMING SCIENTIFIC MEETINGS • • October 3-November 16, 1995 The Building Owners and Managers Association (BOMA) Seminar Series: Rules, Regs and Real Estate, nineteen U.S. locations [Issue 108 Item 50] • November 5-8, 1995 American Association for Cancer Research, Cancer: The Interface Between Basic and Applied Research, Baltimore, Maryland [Issue 104 Item 40] • November 6-9, 1995 Third Annual HERL Symposium: Susceptibility and Risk Assessment, North Raleigh Hilton, Raleigh, North Carolina [Issue 103 Item 30] • November 6-10, 1995 Pathway Analysis and Risk Assessment for Environ- mental Compliance, Kiawah Island, South Carolina [Issue 105 Item 27] • November 12-15, 1995 16th Annual Meeting of the American College of Toxicology, Vienna, Virginia [Issue 104 Item 41 ] • November 13-15, 1995 Southeastern Green Building Conference and Exhibi- tion, Research Triangle Park, North Carolina [Issue 108 Item 45] • November 14-15, 1995 "Due Diligence at Dawn," Denver, Colorado (Nov. 14) and Novi, Michigan (Nov. 15) [Issue 109 Item 31] • November 16-17, 1995 Lymphoma 95: Advances and Controversies, New York, New York [Issue 107 Item 37] • November 22-24, 1995 4th Asia Pacific Conference on Tobacco or Health, Chiang Mai, Thailand [Issue 105 Item 26] • December 1-5, 1995 37th Annual Meeting and Exhibition, The American Society of Hematology, Seattle, Washington [Issue 107 Item 38] • December 3-6, 1995 1995 Annual Meeting of the Society for Risk Analysis, Honolulu, Hawaii [Issue 104 Item 47] • December 4-6, 1995 Issues and Answers to Indoor Air Quality, Falls Church, Virginia [Issue 104 Item 38] • December 6-8, 1995 "Advances in Medical SurveillancP for Environmental and Occupational Health: From Exposure Onset Through Health Outcome," Bethesda, Maryland [In This Issue] • December 9-14, 1995 European Research Conference: Disease Prevention: Scientific Controversies, Castelvecchio Pascoli, Italy [Issue 103 Item 31 ] • December 10-15, 1995 International Conference on Food Factors: Chemistry and Cancer Prevention, Act City Hamamatsu, Hamamatsu, Japan [Issue 104 Item 39] • December 11-12, 1995 National Toxicology Program Workshop: Validation and Regulatory Acceptance of Alternative Toxico- logical Test Methods, Arlington, Virginia [Issue 108 Item 49] • December 14-15, 1995 The Politics of Chemical Risk: Scenarios for a Regula- tory Future - A Workshop, Amsterdam, The Netherlands [Issue 104 Item 45] • January 11-12, 1996 "Fugitive Emissions: Streamlining Implementation and Compliance," New Orleans, Louisiana [Issue 109 Item 27] • January 23-25, 1996 "Risk Assessment of Environmental Mutagens and Carcinogens," Pan-African Environmental Mutagen Society, Cape Town, South Africa [Issue 92 Item 28] SHB z1z
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C-2 ETS/IAQ REPORT, ISSUE I 10 • February 8-13, 1996 AAAS Annual Meeting and Science Innovation Exposition, Baltimore, Maryland [Issue 109 Item 30] • February 17-21, 1996 1996 ASHRAE Winter Meeting, Atlanta, Georgia [In This Issue] • February 19-25, 1996 "Cancer Susceptibility Genes and Molecular Carcino- genesis," Keystone, Colorado [Issue 109 Item 29] • March 10-14, 1996 Society of Toxicology 35th Annual Meeting, Anaheim, California [In This Issue] • June 23-28, 1996 Air & Waste Management Association 89th Annual Meeting and Exhibition, Nashville, Tennessee [Issue 109 Item 28] • July 17-19, 1996 "5th International Conference on Air Distribution in Rooms; Room Vent '96," Yokohama, Japan [Issue 100 Item 28] • July 21-26, 1996 Indoor Air '96: The 7th International Conference on Indoor Air Quality and Climate, Nagoya, Japan [Issue 82 Item 29] • October 6-8, 1996 "IAQ'96: Paths to Better Building Environments," Baltimore, Maryland [In This Issue] SHB 0" •
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• • HR 2099 CONFEREES Senate: Mark Hatfield (R-OR) Chairman - Appropriations Committee Robert Byrd (D-WV), Ranking Minority Member - Appropriations Committee Kit Bond (R-MO), Chairman of the Subcommittee Barbara Mikulski (D-MD), Ranking Minority Member of the Subcommittee Ben Nighthorse Campbell (R-CO) Patrick Leahy (D-VT) Conrad Burns (R-MT) Bennet Johnston (D-LA) Ted Stevens (R-AK) Frank Lautenberg (D-NJ) Richard Shelby (R-AL) Bob Kerry (D-NE) Robert Bennet (R-UT) House: Bob Livingston, (R-LA) Chairman - Appropriations Committee David Obey (D-WI), Ranking Minority Member - Appropriations Committee Jerry Lewis (R-CA), Chairman of the Subcommittee Louis Stokes (D-OH), Ranking Minority Member of the Subcommittee Tom DeLay (R-TX) Alan Mollohan (D-WV) Barbara Vucanovich (R-NV) Jim Chapman (D-TX) James Walsh (R-NY) Marcy Kaptur (D-OH) David Hobson (R-OH) Joe Knollenberg (R-MI) Rodney Frelinghuysen (R-NJ) Mark Neuman (R-WI) ~ O C32 ~ }~.a Issue 110 ~ O Appendix D ~ ~

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