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US Federal court Decision on EPA report - Judge Osteen, July 17, 1998 excerpts:
 
The United States Federal Court Decision
Judge Osteen
July 17, 1998


IN THE UNITED STATES DISTRICT COURT

FOR THE MIDDLE DISTRICT OF NORTH CAROLINA
WINSTON-SALEM DIVISION
Excerpts from the Conclusion:

Rather than reach a conclusion after collecting information, researching, and making findings, EPA categorized ETS as a "known cause of cancer" in 1989. EPA, Indoor Air Facts No. 5 Environmental Tobacco-Smoke, ANR-445 (June 1989) (JA 9,409-11). EPA's Administrator admitted that EPA "managed to confuse and anger all parties to the smoking ETS debate . . . . EPA Memorandum from William K. Reilly, Administrator, to Secretary Louis W. Sullivan 2 (July 1991) (JA 6,754). The Administrator also conceded, "[B]eginning the development of an Agency risk assessment after the commencement of work on the draft policy guide gave the appearance of . . . policy leading science . . . ." Reilly Mem. II at 1 (JA 6,391).

In conducting the Assessment, EPA deemed it biologically plausible that ETS was a carcinoqen. EPA's theory was premised on the similarities between MS, SS, and ETS. In other chapters, the Agency used MS and ETS dissimilarities to justify methodology. Recognizing problems, EPA attempted to confirm the theory with epidemiologic studies. After choosing a portion of the studies, EPA did not find a statistically significant association. EPA then claimed the bioplausibility theory, renominated the a priori hypothesis, justified a more lenient methodology. With a new methodology, EPA demonstrated from the 88 selected studies a very low relative risk for lung cancer based on ETS exposure. Based on its original theory and the weak evidence of association, EPA concluded the evidence showed a causal relationship between cancer and ETS. The administrative record contains glaring deficiencies.

The Radon Research Act authorizes information collection, research, industry inclusion, and dissemination of findings. Whether these actions authorize risk assessments is a matter of general and interstitial statutory construction. So long as information collection on all relevant aspects of indoor air quality, research, and dissemination are the lodestars, the general language of the Radon Research Act authorizes risk assessments as they are defined by NRC and explained in EPA's Risk Assessment Guidelines.

It is clear that Congress intended EPA to disseminate findings from the information researched and gathered. 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.


An order and judgment in accordance with this memorandum opinion will be filed contemporaneously herewith.

This the 17th day July 1998.

[Signed] William L. Osteen
United States District Judge
Link to entire ruling: