Judge Osteen's Ruling on the Tobacco Industry's EPA Lawsuit: Summary and Practical Implications


Judge Osteen's Ruling on the Tobacco Industry's EPA Lawsuit: Summary and Practical Implications

R.J. Reynolds Tobacco Company 7/23/98

Court Findings

A Federal Court has ruled that the EPA wrongly classified secondhand smoke as a Group A (known human) carcinogen.

Contrary to statements by the EPA Administrator, the Court’s ruling was not merely procedural. Among other things, the Court found (pp. 89-90) that EPA:

  • "publicly committed to a conclusion before research had begun"
  • "adjusted established procedure and scientific norms to validate the Agency’s public conclusion"
  • "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"
  • "disregarded information and made findings on selective information"
  • "failed to disclose important findings and reasoning"
  • "left significant questions without answers"
  • "did not disseminate significant epidemiologic information"
  • "excluded industry by violating the [Radon] Act’s procedural requirements"
  • "deviated from its Risk Assessment Guidelines"

The Court noted as "particularly relevant" the fact that the EPA’s own internal risk assessment experts had told the Agency that the Risk Assessment did not support a Group A classification (p.64): "EPA’s Risk Criteria Office, a group of EPA risk assessment experts, concluded that EPA failed to reasonably explain how all relevant data on ETS, evaluated according to EPA Risk Assessment Guidelines’ causality criteria, can support a Group A classification."

The Court concluded that: "EPA produced limited evidence, then claimed the weight of the Agency’s research evidence demonstrated ETS causes cancer."

Bottom Line

It may be politically correct to attack secondhand smoke, but it is not scientifically correct nor, in the Court’s opinion, legally correct.

The Court’s ruling clearly confirms that:

  • EPA deliberately misled the American public about the science concerning secondhand smoke.
  • EPA was guilty of major scientific and procedural errors in preparing its Risk Assessment.
  • EPA cherrypicked information, changed the standards of scientific inquiry and tortured the data to reach a predetermined conclusion.
  • EPA abused its power and authority in an effort to force regulation on secondhand smoke when the scientific basis for the EPA’s claims simply did not exist.

Practical Implications

  1. While it is unlikely that there will be a rush to overturn smoking bans and restrictions currently in place, this ruling raises serious questions about whether there is a legitimate basis for severe and overly restrictive smoking regulations.
  2. Any legislative body currently considering smoking regulations cannot rely on EPA’s now invalid claim that secondhand smoke is a known human carcinogen.
  3. This ruling should create a new environment to foster the development of practical and reasonable solutions that accommodate the preferences of smokers and nonsmokers alike.
  4. Since the ruling goes to the very heart of the science concerning secondhand smoke, it supports the industry’s contention that litigation concerning diseases allegedly resulting from secondhand smoke exposure has no scientific basis or merit.

Background

On July 17, 1998, U.S. District Judge William Osteen (Middle District of North Carolina) issued a summary judgment in the tobacco industry’s 1993 challenge to the EPA’s report, entitled "Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorder."

  1. The Court vacated (invalidated) every part of the 1993 EPA ETS (Environmental Tobacco Smoke) Risk Assessment dealing with lung cancer (Chapters 1-6 and the Appendices).
  2. The Court granted the industry’s motion to move forward on a supplemental pleading claiming the EPA has had improper influence on various organizations that have the power to regulate or influence regulations concerning cigarette smoking.

The Court’s ruling highlighted numerous errors in the scientific process, as well as procedural failings. The Court noted (p. 91):

  1. "EPA’s conduct of the ETS Risk Assessment frustrated the clear Congressional policy underlying the Radon Research Act [the statute EPA cited as authority for its Risk Assessment]."
  2. "EPA also failed the Act’s procedural requirements."

Chapters 7-8 of the Risk Assessment, which deal with effects other than lung cancer, were not challenged by the industry primarily because these chapters did not form the basis for the regulatory efforts to ban smoking that have taken place throughout the country as a result of the EPA’s incorrect and now invalid classification of secondhand smoke as a known human carcinogen.

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