Charles A. Blixt, executive vice president and general counsel of R.J. Reynolds Tobacco Co., today released the following statement in response to Friday's ruling by the U.S. District Court for the Middle District of North Carolina that the EPA wrongly classified ETS as a Group A Carcinogen:
"We feel vindicated by the federal court's decision that the EPA wrongly classified secondhand smoke as a cause of cancer in nonsmokers. This decision should prevent the EPA from becoming a participant in the anti-smoking industry's crusade to ban smoking.
"Striking down the EPA's contention that secondhand smoke causes cancer destroys the basis for those agencies and state and local governments that have banned or restricted smoking because of the EPA's classification. The court's ruling supports Reynolds Tobacco's long-held belief that the science does not justify public smoking bans.
"The EPA was able to claim ETS causes cancer in nonsmokers only after it cherrypicked information, changed the rules of standard scientific inquiry and tortured the data to fit its agenda. Essentially, the EPA painted a politically correct bulls-eye on the back of the tobacco industry and then perverted the scientific process to fit its preconceived conclusions.
"The court's decision goes right to the heart of the science concerning secondhand smoke. If the EPA had followed its own rules and well-accepted rules of science, it could not have concluded that secondhand smoke causes cancer.
"The American public relies on the government to provide fair, accurate, well-supported information in its pronouncements about public health. Perversions of the scientific process to support a preconceived, politically motivated, public policy agenda is a reprehensible violation of the public trust.
"This federal court decision transforms the controversy surrounding secondhand smoke from a political crusade to a debate that is based on scientific fact. It should have far-reaching ramifications, sending the message that the public trust should be upheld and policy decisions should be based on a fair evaluation of all of the available scientific evidence -- not on political science.
"The EPA stirred up public fears about cancer and trumped up a case against secondhand smoke in an effort to do what the Agency has no regulatory authority to do -- force smoking bans.
"Reynolds Tobacco has long maintained that an objective observer looking at the full body of available scientific evidence would reach very different conclusions from those of the EPA.
"That is what happened in March when a jury in Indiana failed to conclude that secondhand smoke caused the death of Mildred Wiley. And that is what Judge Osteen has found after evaluating more than 12,000 pages of evidence concerning the EPA's ETS Risk Assessment. Judge Osteen is the same judge who ruled against the tobacco industry last year, refusing to strike down FDA's claim that it has authority to regulate cigarettes.
"Judge Osteen called the EPA's efforts an 'epidemiological web.' He firmly noted: 'Gathering all relevant information, researching, and disseminating findings were subordinate to EPA's demonstrating ETS a Group A carcinogen.'
In its ruling, the court noted:
"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 Plaintiff's products and to influence public opinion. In conducting the ETS Risk Assessment, EPA 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, EPA produced limited evidence, then claimed the weight of the Agency's research evidence demonstrated ETS causes Cancer." (Pages 89 and 90)
"Using its normal methodology and its selected studies, EPA did not demonstrate a statistically significant association between ETS and lung cancer. This should have caused EPA to reevaluate the inference options used in establishing its plausibility theory. A risk assessment is supposed to entail the best judgment possible based upon the available evidence. Legal citation omitted. Instead, EPA changed its methodology to find a statistically significant association." (Page 81)
Following are additional excerpts from Judge Osteen's opinion:
"The record and EPA's explanation to the court make it clear that using standard methodology, EPA could not produce statistically significant results with its selected studies." (Page 77)
" ... When an agency changes its methodology mid-stream, as EPA did here, it has an obligation to explain why." (Page 78)
"The studies EPA selected did not include a significant number of studies and data which demonstrated no association between ETS and cancer." (Page 80)
"In summary, Plaintiffs raise legitimate questions not addressed in the record regarding EPA's bioplausibility theory. If confronted by a representative committee that voiced industry concerns, EPA would likely have had to resolve these issues in the record. It is not clear whether EPA could have or can do so. These issues are more than periphery. If EPA's a priori hypothesis fails, EPA has no justification for manipulating the Agency's standard scientific methodology." (Page 65)
"Since Chapter 2 found ETS and MS mainstream smoke not sufficiently similar, Chapter 3 found them similar, and Chapter 6 found them dissimilar, EPA apparently used a different risk assessment methodology for each chapter .... The court is faced with the ugly possibility that EPA adopted a methodology for each chapter, without explanation, based on the outcome sought in that chapter. ... It is striking that MS and ETS were similar only where such a conclusion promoted finding ETS a carcinogen." (Pages 60 and 61)
"EPA's study selection is disturbing. 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 .... Third, EPA's selective use of data conflicts with the Radon Research Act .... In conducting a risk assessment under the Act, EPA deliberately refused to assess information on all aspects of indoor air quality." (Page 72)
"Finally, when an agency conducts activities under an act authorizing information collection and dissemination of findings, the agency has a duty to disseminate the findings made. EPA did not disclose in the record or in the Assessment: its inability to demonstrate a statistically significant relationship under normal methodology; the reasoning behind adopting a one-tailed test, or that only after adjusting the Agency's methodology could a weak relative risk be demonstrated. Instead of disclosing information, the Agency withheld significant portions of its findings and reasoning in striving to confirm its a priori hypothesis." (Pages 78 & 79) SOURCE R.J. Reynolds Tobacco Co.
CONTACT: Seth Moskowitz of R.J. Reynolds, 336-741-7698
ORIGNAL-LANGUAGE: R.J. Reynolds Tobacco Co.; Environmental Protection Agency
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