Tobacco Documents Online

Air Pollution 7-22-93 Lippman said a.90 pereent confidence level on the- one-tail test is equivalent to a 95 percent confidence level on the two-tail test. He said EPA decided in the course of the study that the one-tail test was adequate. That test establishes a bell curve extending between two extreme assumptions - that ETS causes lung cancer versus that it protects against lung cancer. Without weighing the latter - a decision based large- ly on what EPA Administrator Carol Browner said was "the total weight of evidence'' gathered from numerous studies and a pooling of data - the agency came up with the 90 percent confidence level for its conclusions. Lippman said that if researchers had "no idea which direction to expect the difference" they would have used the two-tail test. However, that test actually would have assumed on one end that ETS had respira- tory benefits. EPA GRILLED ONRI'SK ASSESSMENT ANALYSIS SHOWING SECOND HAND SMOKE UNHEALTHFUL The scientific methodology the Environmental Pro- tection Agency used to conclude that second-hand tobac- co smoke causes cancer came under vigorous attack in two separate congressional committees July 21. Members in both the House Energy and Commerce Subcommittee on Health and the Environment and the House Agriculture Subcommittee on Specialty Crops and Natural Resources lambasted EPA for ignoring one study that may have harmed the agency's case, changing the confidence levels it uses in making scien- tific determinations, and disregarding criticisms of many in the scientific community. At issue is a report EPA published in January entitled Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders. It blamed environmental tobacco smoke (ETS) for 3.000 lung cancer deaths each year in adults and respiratory health problems in children. The report classified ETS as a Class A carcinogen. a classification it shares with benzene. asbestos, radon, and about a dozen other chemicals, "The agency has deliberately abused and manipu- lated the scientific data in order to reach a predeter- mined, politically motivated result." Thomas Bliley (R-Va.)„ ranking minority on the environment and health subcommittee, charged. He pointed to an example most often raised by critics of the agency's assessment: its reliance on a 90 percent confidence level in the results instead of the 95 percent it has followed in its other studies. His comments were corroborated by witnesses who appeared before the agriculture subcommittee. W. Gary Flamm, a retired toxicologist with the Food and Drug Admini'stration, told the agriculture subcommittee the EPA study "asserts ETS is suffi- ciently similar to mainstream tobacco smoke" and can be declared carcinogenic "based solely on studies of active smoking." He said in dropping the 95 percent confidence level'; which would have rendered EPA's conclusions statisti- cally insignificans. the agency deviated from the standard it used in its first draft of the document. "In other words, the authors of the draft report significantly weakened the scientific standard: tradi- tionally used to determine the confidence that could be placed in the statistical, data." Flamm said. No reasons were given for this change„ he said, leading to the assumption that it was done to show more studies backed the agency's position. "I can discern no reason for such a change except a desire to support a predetermined& policy position," Flamm said. Morton Lippman. chair of the EPA Science Adviso- ry 13oard' committee that peer reviewed the agency's risk assessment documents, said the agency switched from using a "two-tail test" to gauge the statistical significance of EPA's results to a"one-tail test." In doing so, he said, "EPA made a defensible judge- ment end'orsed by the committee." . Spousal Smoking Study Not Reviewed Bliley and other Republican members of the health and environment subcommittee, chaired by Rep. Hen- ry Waxman (D-Calif), also criticized the agency for not including in its findings results from one of the largest case-control studies on spousal smoking. The so-called Brownscn report, according to Bliley and researchers asked to speak in behalf of the Tobac- co Institute, showed no relative increased risk of health problems for spouses of smokers. That study, when combined with EPA's analysis, shows statistical- ly insignificant results regarding the relationship of ETS to respiratory problems. Lippman said the report had not been peer reviewed or published at the time the agency was making its analysis and'therefore had not been included. Even so, he said, the Brownson study showed an increase in adverse health effects to individuals at higher expo- sure levels. He said that corresponds with EPA's assertions that the greater the exposure, the greater the risk. In the agriculture subcommittee in which EPA staff officials were grilled for about three hours on the agency's report, Rep. Charles Rose (D-NC), chairman of the subcommittee, accused the agency of issuing the report "in a hurry between changes in administra- tions" and forcing bad policy. He charged the agency also gave too much weight to another study that did not consider "confounding factors" such as other environmental elements that may cause respiratory problems. Steven Bayard, EPA's project manager for the ETS study, said committee members seemed to criticize those studies backing the agency's position and said he would have analyzed the confounding factors if he thought they had existed. Browner defended the agency's report and played up for the committee its conclusion about ETS's harm- ful effect on children. In her testimony, Browner also announced the release of an agency brochure, What You Can Do About Secondhand Smoke. The agency also announced later in the afternoon that it was filing a motion; to dismiss a case against it from the tobacco industry. The tobacco industry filed suit June 22 asking the U.S. District' Court for the Middle District of North Carolina to say the agency acted illegally in.publish- ing the report and in declaring ETS a Class A carcino- gen (Flue-Cured Tobacco Cooperative Stabiliza- tion Cooperative v. EPA, DC MDNC, 93:CV370, 6/22/93).7 Copyngnt z 1993 dby THE BUREAU OF NATIONAL AFFAIRS. INC.. wasnington. D!C. 20037 -- nn.e.ne.en.¢,,N1