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The EPA Report

In December of 1992 the EPA released it's now famous report on second hand smoke. The report claimed that SHS causes 3,000 deaths a year, and classified it as a class A carcinogen.

Note: Although the official date of this report is December, 1992, it is commonly referred to as the EPA '93 study, probably because it became widely available in '93.

This was, and remains, a powerful weapon in the anti-smokers arsenal. If a smoker is only hurting himself, he can argue that it's no one else's business. But if he is hurting everyone around him, all kinds of restrictive legislation can be justified.

Did this study show SHS is deadly? Let's examine the facts carefully.

Fact: In 1992 the EPA issued a report which claimed that Environmental Tobacco Smoke (ETS) caused 3,000 deaths per year.

Fact: ETS is commonly referred to as Second Hand Smoke (SHS). The two terms are interchangeable.

After reading each of the following facts, ask yourself "Does this fact make the study more credible, or less credible?

Fact: The EPA announced the results of the study before it was finished.

Fact: The study was a Meta Analysis, an analysis of existing studies.

Meta Analysis is very difficult to do accurately, and is the easiest kind of study to fake and manipulate. With a disease as rare as lung cancer, leaving out just a few important studies can skew the results considerably. (Approximately 87% of lung cancer occurs among primary smokers. Another 10% occurs in asbestos workers, leaving just 3% of the cases without an obvious cause.)

The term "Meta Study" is often used to describe this type of report, but the word "study" is inaccurate. The EPA has never conducted nor financed a single ETS study. They have only analyzed the studies of others. It is more accurate to refer to it as an analysis, and to its publication as a report.

Fact: The first step in a meta analysis is identifying all of the relevant studies. The EPA located 33 studies that compared ETS exposure to lung cancer rates.

Fact: The EPA selected 31 of the 33 studies. Later they rejected one of their chosen studies, bringing the total to 30.

Fact: On page 3-46 of the report the EPA estimates, based on nicotine measurements in non-smokers blood, "this would translate to the equivalent of about one-fifth of a cigarette per day."

Fact: Studies that measured actual exposure by having non-smokers wear monitors indicate even this low estimate is exaggerated. Actual exposure (for people who live and/or work in smoky environments) is about six cigarettes per year. (See also the study by Oak Ridge National Laboratories.)

Fact: In 1995 The Congressional Research Service (CRS) released a review of the EPA report.

The CRS was highly critical of both the EPA's methods and conclusions.

Fact: According to the CRS "The studies relied primarily on questionnaires to the case and control members, or their surrogates, to determine EST exposure and other information pertinent to the studies."

Questionnaires can be notoriously inaccurate, as discussed in Statistics 102, but in this case some of them were not even filled out by the people being studied, but by "surrogates." In other words, some of the information was unverified hearsay.

Fact: On page 23 of the study, paragraph 3, the CRS noted that out of 30 studies, only five found a statistically significant risk at the 95% confidence level, and one showed a statistically significant negative risk (a protective effect). The remaining 24 studies showed no statistically significant increase or decrease in risk.

Fact: Three other large US studies were in progress during the EPA's study. The EPA used data from one uncompleted study, the Fontham study, and ignored the other two, Brownson and Kabat.

Fact: The Fontham study showed a small increase in risk. The CRS report referred to it as "a positive risk that was barely statistically significant." (p. 25)

Fact: The CRS report said the Brownson study, which the EPA ignored, showed "no risk at all." (p.25)

Fact: The "scientists" who conducted the Fontham study refused to release their raw data for years. They were finally forced to when Philip Morris won a lawsuit to gain access to it.

Most researchers routinely make their raw data available after studies have been published. Does Fontham's refusal to make the data available make them more credible, or less credible?

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Fact: The EPA based their numbers on a meta analysis of just 11 studies. The analysis showed no increase in risk at the 95% confidence level.

Fact: Even after excluding most of the studies, the EPA couldn't come up with 3,000 deaths, but they had already announced the results. So they changed the CI to 90%, which, in effect, doubled their margin of error.

Fact Worth Repeating: Instead of using the 95% confidence interval, the statistical standard that has been used for decades, the EPA doubled their margin of error to achieve their pre-announced results.

Would any legitimate epidemiologist keep their job if they were caught doubling their margin of error to support a pre-announced conclusion?

Fact: After juggling the numbers, The EPA came up with an RR (Relative Risk) of ETS causing lung cancer 1.19. In layman's terms that means:

• Exposure to the ETS from a spouse increases the risk of getting lung cancer by 19%.
• Where you'd usually see 100 cases of cancer you'd see 119.

Fact: A RR of less than 2.0 is usually written off as an unimportant result. An RR of 3.0 or higher is considered desirable. (See Statistics 101 for more details.)

This rule is routinely ignored when the subject is second hand smoke.

Facts: In review: The EPA ignored nearly two-thirds of the data. The EPA then doubled their margin of error to come up with their desired results.

Fact: Although the EPA declared ETS was a Class A carcinogen with an RR of 1.19, in analysis of other agents they found relative risks of 2.6 and 3.0 insufficient to justify a Group A classification.

Fact: In 1998 Judge William Osteen vacated the study - declaring it null and void after extensively commentating on the shoddy way it was conducted. His decision was 92 pages long.

Fact: Osteen used the term "cherry-picking" to describe he way the EPA selected their data. "First, there is evidence in the record supporting the accusation that EPA "cherry picked" its data. Without criteria for pooling studies into a meta- analysis, the court cannot determine whether the exclusion of studies likely to disprove EPA's a priori hypothesis was coincidence or intentional. Second, EPA's excluding nearly half of the available studies directly conflicts with EPA's purported purpose for analyzing the epidemiological studies and conflicts with EPA's Risk Assessment Guidelines."

Fact: Osteen found other deep flaws in the the EPA's methodology. In his judgment he stated: "The record and EPA's explanations to the court make it clear that using standard methodology, EPA could not produce statistically significant results with its selected studies. Analysis conducted with a .05 significance level and 95% confidence level included relative risks of 1. Accordingly, these results did not confirm EPA's controversial a priori hypothesis. In order to confirm its hypothesis, EPA maintained its standard significance level but lowered the confidence interval to 90%. This allowed EPA to confirm its hypothesis by finding a relative risk of 1.19, albeit a very weak association. EPA's conduct raises several concerns besides whether a relative risk of 1.19 is credible evidence supporting a Group A classification. First, with such a weak showing, if even a fraction of Plaintiffs' allegations regarding study selection or methodology is true, EPA cannot show a statistically significant association between ETS and lung cancer."

Fact: The following is another direct quote from Judge Osteen's decision: "In this case, EPA publicly committed to a conclusion before research had begun; excluded industry by violating the Act's procedural requirements; adjusted established procedure and scientific norms to validate the Agency's public conclusion, and aggressively utilized the Act's authority to disseminate findings to establish a de facto regulatory scheme intended to restrict Plaintiffs, products and to influence public opinion. In conducting the ETS Risk Assessment, disregarded information and made findings on selective information; did not disseminate significant epidemiologic information; deviated from its Risk Assessment Guidelines; failed to disclose important findings and reasoning; and left significant questions without answers. EPA's conduct left substantial holes in the administrative record. While so doing, produced limited evidence, then claimed the weight of the Agency's research evidence demonstrated ETS causes cancer. Gathering all relevant information, researching, and disseminating findings were subordinate to EPA's demonstrating ETS a Group A carcinogen."

Most of the media ignored the judge's decision.

When confronted with this decision, many anti-tobacco activists and organizations harp on the fact that Judge Osteen lives in South Carolina. The obvious implication is that he's influenced by the tobacco industry in his state. It may also be an appeal to the "stupid southerner" stereotype.

Fact: Judge Osteen has a history of siding with the government on tobacco cases.

Fact: In 1997 Judge Osteen ruled the FDA had the authority to regulate tobacco.

So much for his alleged bias.

Fact: Although this study has been thoroughly debunked by science and legally vacated by a federal judge, it is still regularly quoted by government agencies, charity organizations and the anti-smoking movement as if it were legitimate.

Fact: Anyone referring to EPA classifying ETS as a Class A carcinogen is referring to this study.

Opinion: You should seriously question the credibility of anyone who refers to this study, or any of the conclusions that it reached, as if they were facts. That includes everyone who refers to the EPA's ruling that ETS is a Class A Carcinogen. Once they do, every subsequent statement they make should be considered highly suspicious until it is thoroughly verified.

Fact: Most of the information on this page was gleaned from Judge Osteen's 92 page decision, the CRS report, and the EPA's study.

Fact: The EPA fought to have Osteen's decision overturned on technical grounds. They succeeded in 2002 on the narrowest of technicalities. The fourth circuit court of appeals ruled that because the report was not an official policy document Osteen's court did not have jurisdiction.

Fact: In their appeal the EPA did not answer a single criticism on the 92 page report, nor challenge a single fact put forth by Judge Osteen. Not one.

You are strongly encouraged to read these documents yourself. You can find the judge's entire decision here. The CRS report is available here. The EPA report over six hundred pages long, and we recommend you order a hard copy. It is available to US citizens at no charge. Call (800) 438-4318 and ask for document EPA/600/6-90/006F. The title of the report is "Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders." It is also available as on line as a pdf file. Note: this is a four megabyte file.

Fact: Carol Browner, the former head of the EPA, still insists that this study is valid!

More Information

The Smokers Club Inc. has complied a wealth of articles about this study and other shenanigans by the EPA.

Enough facts, already. Now for some opinions:

Sidney Zion, in the New York Daily News

The LA Times on the EPA's agenda

 

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