FLUE-CURED TOBACCO CO-OP. STABIL. v. USEPA, 6:93CV00370.

Decision Date20 July 1994
Docket NumberNo. 6:93CV00370.,6:93CV00370.
CourtU.S. District Court — Middle District of North Carolina
PartiesFLUE-CURED TOBACCO COOPERATIVE STABILIZATION CORPORATION, The Council for Burley Tobacco, Inc., Universal Leaf Tobacco Company, Incorporated, Philip Morris Incorporated, R.J. Reynolds Tobacco Company, and Gallins Vending Company, Plaintiffs, v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, and Carol Browner, Administrator, Environmental Protection Agency, Defendants.

James D. Blount, Jr., James K. Dorsett, Jr., Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, Raleigh, NC, for plaintiffs Flue-Cured Tobacco Co-op Stabilization Corp. and Counsel for Burley Tobacco, Inc.

Keith Vaughn, Dewey W. Wells, Jeffrey Lee Furr, Womble, Carlyle, Sandridge & Rice, Winston-Salem, NC, for plaintiffs Universal Leaf Tobacco Co., Inc., Philip Morris Inc. and R.J. Reynolds Tobacco Co.

Richard B. Howington, Allman, Spry, Humphreys & Leggett, P.A., Winston-Salem, NC, for plaintiff Gallins Vending Co.

Benjamin H. White, Jr., John W. Stone, Jr., Office of U.S. Atty., Greensboro, NC, Myles E. Flint, U.S. Dept. of Justice, Environmental & Natural Resources Div., John Copeland Nagle, U.S. Dept. of Justice, Environmental Resources Div., Environmental Defense Section, Laura H. Neuwirth, U.S. E.P.A., Office of Gen. Counsel, Gerald H. Yamada, U.S. E.P.A., Acting Gen. Counsel, Gregory B. Foote, U.S. E.P.A., Asst. Gen. Counsel, Alice L. Mattice, U.S. Dept. of Justice, Environmental & Natural Resources Div., Washington, DC, for defendants U.S. E.P.A. and Carol Browner.

George M. Cleland, Winston-Salem, NC, Cornish F. Hitchcock, Alan B. Morrison, Public Citizen Litigation Group, Matthew L. Myers, Asbill, Junkin & Myers, Chartered, Washington, DC, for movants American Lung Ass'n, American Heart Ass'n, American Cancer Soc. and American Public Health Ass'n and Public Citizen.

Diana Evans Ricketts, Bode, Call & Green, Raleigh, NC, Daniel J. Popeo, Richard A. Samp, Washington Legal Foundation, Washington, DC, for movant Washington Legal Foundation.

MEMORANDUM OPINION

OSTEEN, District Judge.

This case involves an action for declaratory and injunctive relief brought against the U.S. Environmental Protection Agency ("EPA") by various tobacco production and distribution interests, including growers, marketers and dealers, cigarette manufacturers, and a cigarette vending machine company. Plaintiffs challenge the issuance of a report by EPA classifying environmental tobacco smoke ("ETS") as a known human carcinogen. The case is presently before this court on EPA's motion to dismiss the Complaint under Federal Rules of Civil Procedure 12(b)(1) and 12(b)(6). The court has jurisdiction pursuant to 28 U.S.C. § 1331 and venue is proper pursuant to 28 U.S.C. § 1391(e). Declaratory relief is authorized by 28 U.S.C. § 2201. After consideration of each side's thorough and most helpful briefs and corresponding amicus curiae briefs, the court has determined that oral argument is not necessary. At this time, for the reasons stated below, the court will deny EPA's motion to dismiss on Counts I, II, and III, and will defer its ruling on Count IV.

I. BACKGROUND
A. Statutory and Factual History

In 1986, Congress passed the Radon Gas and Indoor Air Quality Research Act. Pub.L. 99-499, §§ 401-405, 100 Stat. 1758, reprinted in 42 U.S.C. § 7401 note ("the Radon Act" or "the Act"). The Radon Act required the Administrator of the EPA to establish a research program designed in part to gather data and information on all aspects of indoor air quality and to assess appropriate federal government actions to reduce the health risks associated with indoor air quality problems. Id. § 403(a). Mandated elements of the program included research and development concerning the identification, characterization, and monitoring of indoor air pollution; research relating to the health effects on humans of indoor air pollution; demonstration of methods for reducing or eliminating indoor air pollution; and the dissemination of information to assure the public availability of the findings of the research program. Id. § 403(b). Congress also required the Administrator to establish a committee of federal agency representatives and an advisory group of individuals representing state, scientific, industrial, and public interests to assist her in implementing the research program. Id. § 403(c). Congress, however, prohibited the Administrator from carrying out any regulatory program or any activity other than the research, development, and reporting or information dissemination specified in the Act, although she was not prohibited from doing so under the authority of any other law. Id. § 404.

In January 1993, pursuant to the authority conferred upon it by the Radon Act and after public review of and comment on two drafts,1 EPA formally released a report evaluating the human health effects of ETS.2 Office of Health & Envtl. Assessment, U.S. Envtl. Protection Agency, Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders xvi (EPA/600/6-90/006F Dec. 1992) ("the Report"). According to EPA, the Report, which is intended to be "a useful guide for policy makers and citizens everywhere," represents the most recent scientific assessment of the health effects of ETS and the first conducted by EPA itself. It "confirms and strengthens" two prior government reports,3 "and provides important new documentation of the emerging scientific consensus that tobacco smoke is not just a health risk for smokers." Id. at xv.

The Report's primary general finding is that "the widespread exposure to ETS in the United States presents a serious and substantial public health impact." Id. at 1-1, 6-32. More specifically, the Report "demonstrates conclusively" that ETS increases the risk of lung cancer in healthy nonsmokers. Id. at xv. One of its primary specific findings is that ETS is responsible for approximately 3,000 lung cancer deaths annually in U.S. nonsmokers. Id. at 1-1, 1-4; see generally id. at 6-1-6-31. The Report's most important conclusion, and the one challenged in this action, is that ETS is a Group A (known human) carcinogen. Id. at 1-1, 1-4, 5-68. The Report also concluded that ETS exposure in children is causally associated with an increased risk of lung infections, a reduction in lung function, and an increased risk of asthma. Id. at 1-1, 1-5-1-6; see generally id. at 7-1-8-16.

B. The Complaint

On June 22, 1993, Flue-Cured Tobacco Cooperative Stabilization Corporation, The Council for Burley Tobacco, Universal Leaf Tobacco Company, Philip Morris Incorporated, R.J. Reynolds Tobacco Company, and Gallins Vending Company filed a complaint in this court challenging the legality of EPA's Report and its classification of ETS as a known human carcinogen. Plaintiffs allege that EPA, in conducting its research and arriving at its conclusion, manipulated and "cherry-picked" data, ignored critical statistical studies and chemical analyses, failed to account for confounding factors and sources of bias, violated basic statistical principles designed to minimize the possibility that an apparent association is due to chance, and generally altered EPA's usual models, assumptions, and methodologies when their use would not support the Agency's desired conclusions. Plaintiffs also allege that EPA issued the Report and classification with the intent that they would have a substantial regulatory impact that would result in the restriction of smoking in the workplace and in public. Plaintiffs further allege that, in fact, the Report has had a substantial regulatory impact, as evidenced by, among other examples, the U.S. Postmaster's order of a nationwide ban on smoking in postal facilities and the introduction in Congress of legislation that would prohibit smoking in all buildings owned or leased by federal agencies. Finally, Plaintiffs allege that the release of the Report has caused them substantial and immediate harm, including false disparagement of their product and loss of business and economic goodwill.

On the basis of these allegations, the Complaint presents four claims. Count I, charging a violation of the Administrative Procedure Act ("APA"), 5 U.S.C. § 706(2)(C), alleges that EPA has exceeded the authority granted to it under the Radon Act, both because the classification of ETS as a Group A carcinogen does not constitute research permitted under the Act and because EPA has not established the advisory group mandated by the Act or used the agency representative committee to assist it in its research. Count II alleges that the classification of ETS as a known human carcinogen is arbitrary and capricious, 5 U.S.C. § 706(2)(A), because EPA violated its internal scientific guidelines and because EPA ignored data contrary to its conclusions and based its conclusions on models, assumptions, and methods that are inaccurate, flawed, and not accepted by the scientific community. Count III charges a violation of 5 U.S.C. § 706(2)(D), that agency findings and conclusions are to be set aside if arrived at without observance of procedures required by law, again on the ground that EPA did not follow its guidelines when classifying ETS. Finally, Count IV charges that EPA's failure to comply with the Radon Act and agency guidelines constitutes a violation of Plaintiffs' right to due process under the Fifth Amendment. For each count, Plaintiffs seek relief in the form of a declaratory judgment that the issuance of the Report and the classification of ETS as a known human carcinogen are unlawful. Plaintiffs also seek an injunction ordering EPA to withdraw the Report and the classification.

II. DISCUSSION
A. Administrative Procedure Act Claims

1. Standard of Review Under Rule 12(b)(1): In addressing Defendants' challenge to Plaintiffs' APA claims under Rule 12(b)(1) (subject matter jurisdiction), the court will read the Complaint as a whole and will construe it...

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