Tobacco Documents Online

THE U.S. EPA REPORT ON ETS Introduction On January 7, 1993, the U.S. Environmental Protection Agency (EPA) issued a report claiming that environmental tobacco smoke (ETS) is a "Group A" or "known human carcinogen." The EPA concluded that ETS exposure is responsible each year for 3,060 lung cancer deaths among non-smokers in the United States. The report also discussed childhood respiratory health. The EPA Carcinogen Classification Scheme It is important to understand that the EPA's classifying ETS as a Group A • carcinogen does not mean that ETS actually causes cancer in real-world circumstances. The air of every single office, restaurant and home contains substances that have been listed as Group A or Group B carcinogens by the EPA. These substances are produced by or are found in an almost endless list of office and consumer products as well as in food and water. In fact, when asked by reporters about the magnitude of the lung cancer risk that EPA was claiming for ETS, Dr. Morton Lippman -- chairman of the EPA Science Advisory Board panel that reviewed the Agency's ETS report -- described the purported risk as "probably less than you took to get here through Washington traffic." Summary of Major Scientific Deficiencies • The U.S. EPA report on ETS has been severely criticised by scientists and public policy experts. Following are some of the criticisms: Lung Cancer The EPA ignored generally accepted scientific standards and violated its own carcinogen assessment guidelines. • The EPA wrongly assumed a purported similarity between ETS and the mainstream smoke to which the active smoker is exposed. • The EPA ignored the substantial scientific literature that shows that ETS is chemically and physically different from the mainstream smoke that is inhaled by the active smoker. The USA EPA Report on ETS March, 96 Pa}e 1

• It also ignored differences in route of exposure and dosage considerations. In both respects, EPA ignored its own carcinogen assessment guidelines. • Scientists have pointed out that the methodology used by EPA in condemning ETS would require the Agency to classify as carcinogenic an almost endless list of substances, including chlorinated drinking water supplies and many of the foods we eat. The EPA selected a group of epidemiologic studies to reach a predetermined conclusion. • If all of the studies available to the EPA at the time it drafted its report had been taken into account, the Agency could not have concluded that exposure to ETS is responsible for a statistically significant increase in lung cancer risk. • • It ignored three important studies that did not confirm its preconceptions, including two studies that had been funded in part by the U.S. National Cancer Institute (NCI). These studies found no overall statistically significant association between exposure to ETS and lung cancer. • The EPA ignored the entire body of data that was available on ETS exposure in the workplace and in public places - which did not support the EPA's preconceptions - focusing instead exclusively on ETS exposure in the home. It also ignored data focusing on males and on childhood ETS exposure. The Agency then took additional steps to reach its conclusions. • The EPA did not account for the deficiencies in the existing studies concerning exposure, bias and alternative explanations for the results those studies reported. • • The EPA lowered the test for statistical significance, essentially doubling the chance of its conclusion being attributable to chance. Application of the conventional test would have forced the Agency to conclude that ETS has not been shown to be associated with a statistically significant increase in the incidence of lung cancer. Childhood respiratory health In addition to the general problems that pervade the EPA report, the EPA's conclusions concerning the respiratory health of children ignored many factors that could explain the associations that have been reported. The USA EPA Report on ETS March, 96 Page 2

0 U.S. Congressional Criticism of the EPA Report In 1994; Jane Gravelle of the Congressional Research Service testified before a U.S. Senate subcommittee concerning the EPA report on ETS: "Based on that evidence, as indicated in this testimony, our evaluation was that the statistical evidence does not appear to support a conclusion that there are substantial health effects of passive smoking. " Even more recently, a 1995 CRS report emphasised the dubious nature of the many assumptions made by EPA. After discussing some of the major deficiencies of the EPA's analysis, the CRS pointed out that the risk claimed by EPA is "very small and is not statistically significant at the 95 percent level ". The report then went on to note that studies ignored by EPA, or published after the EPA report was issued, did not "clarify (or confirm) the existence of a risk ". Conclusions The widespread criticisms that have been directed at the U.S. EPA report on ETS go to the very heart of the scientific process. In view of the many deficiencies in that report, it should not be used to set policies with respect to smoking. Even less should that report be used as a model for determining whether a particular exposure may have adverse health consequences. ### 0 The USA EP.k Report on E"I S March, 96 Page 3