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Flue-Cured Tobacco Coop. Stabilization Corp. v. EPA

ELR Citation: 28 ELR 21445
Nos. 6:93CV00370, 4 F. Supp. 2d 435/(M.D.N.C., 07/17/1998) EPA report vacated

The court holds that a U.S. Environmental Protection Agency (EPA) report classifying environmental tobacco smoke (ETS) as a known carcinogen violated the Radon Gas and Indoor Air Quality Research Act. The report classifies ETS as a group A carcinogen known to cause cancer in humans. The court first holds that the Radon Research Act authorizes EPA's risk assessment and classification of ETS. In the Radon Research Act, Congress intended EPA to research, collect, and disseminate information and findings on indoor air pollutants' effect on health without engaging in regulating. Risk assessments are incidental to researching effects on health, characterizing sources of pollutants, and making findings. The court next holds that EPA's ETS activities do not constitute a prohibited regulatory program under the Radon Research Act. Although the risk assessment and carcinogenic classification constituted de facto regulatory activity, it did not amount to formal regulation. EPA issued no regulations and made no attempt to manage ETS risks directly. The court then holds that the Toxic Substance Control Act's (TSCA's) tobacco prohibition does not apply to the Radon Research Act. Congress' defining "chemical substance" under TSCA to exclude tobacco does not mean Congress conclusively removed tobacco from EPA's jurisdiction. It means Congress removed tobacco from the authority granted to EPA under TSCA.

The court next holds that EPA failed to comply with the procedural requirements of establishing and consulting with a representative advisory group as mandated by Congress in Radon Research Act §403(c) when it only consulted with the EPA Science Advisory Board (SAB). Had Congress meant the SAB when requiring a representative advisory group, it would have specified the SAB as it did in the following paragraph of the Act. In addition, Congress' use of "establish" suggests that EPA should create a group. And the Indoor Air Quality/Total Human Exposure Committee did not satisfy §403(c)'s requirement. The court also rejects EPA's argument that §403(c) is generally worded and does not make the formation of a representative advisory committee a prerequisite that must be satisfied before EPA can undertake a specific activity under the Act. There is no evidence in the record, nor does EPA argue, that EPA established the committee during or after any activity conducted under the Act. Moreover, §403(c) requires EPA to seek the committee's assistance in carrying out the research program, which means that Congress intended consultation at least while EPA conducted research.

Next, the court holds that legitimate questions were raised concerning 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. The court further holds that EPA consultation with an advisory committee would have resulted in a record that explained EPA's selective use of epidemiological studies. There is evidence in the record that EPA "cherry picked" its data. EPA's excluding nearly one-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. And EPA's selective use of data conflicts with the Radon Research Act. The court also holds that using its normal methodology and its selected studies, EPA did not demonstrate a statistically significant association between ETS and lung cancer. Instead, EPA changed its methodology to find a statistically significant association.

The court concludes that 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 Radon Research Act's procedural requirements, adjusted established procedure and scientific norms to validate EPA's public conclusion, and aggressively utilized the Act's authority to disseminate findings to establish a de facto regulatory scheme intended to restrict tobacco products and influence public opinion. In conducting the ETS risk assessment, EPA disregarded information and made findings on selective information, did not disseminate significant epidemiological information, deviated from its risk assessment guidelines, failed to disclose important findings and reasoning, and left significant questions without answers. Thus, the court vacates the first six chapters of EPA's report.

[A prior decision is this litigation is published at 25 ELR 20089.]

Counsel for Plaintiffs
James K. Dorsett Jr.
Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan
2500 First Union Capitol Ctr., Raleigh NC 27602
(919) 821-1220

Counsel for Defendants
Alice Mattice, Myles Flint
Environment and Natural Resources Division
U.S. Department of Justice, Washington DC 20530
(202) 514-2000