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November 20, 1987

A.L. Laboratories, Inc., Plaintiff,
Environmental Protection Agency, Defendant; Chemical Manufacturers Association, Plaintiff, v. Lee M. Thomas, Administrator, United States Environmental Protection Agency, et al., Defendants

The opinion of the court was delivered by: GASCH

 HONORABLE OLIVER GASCH, Senior Judge, United States District Court

 Plaintiffs' complain that the substances that they manufacture were improperly included on the extremely hazardous substances list because of a clerical error or "seriously flawed" scientific methods. Although the EPA was notified of these alleged errors, the substances remain on the list. The plaintiffs seek declaratory and injunctive relief, enjoining enforcement of EPA rules that allegedly decline to delete these substances from the list and ordering that these substances be removed from the list.

 History of the "Extremely Hazardous Substances" List

 In November 1985, EPA compiled and published a list of 402 "Extremely Hazardous Substances" as part of its Chemical Emergency Preparedness Program ("CEPP list") the purpose of which is to help local governments identify chemicals that could have acute adverse health effects if released accidentally. See 51 Fed. Reg. 41,572-73 (Nov. 17, 1986). The CEPP list was derived primarily from the Registry of Toxic Effects of Chemical Substances ("RTECS") created and maintained by the National Institute of Occupational Safety and Health. Id. at 41,574. Both bacitracin and the phthalate esters were included on the list.

 In October 1986, SARA was enacted and signed into law. Title III, the Right-to-Know Act, establishes a program to assist state and local governments in planning for accidental releases of extremely hazardous substances. 42 U.S.C.S. §§ 11001-11050 (Law. Co-op. 1987). The Act provided that by November 17, 1986 the EPA would publish a list of substances ("Right-to-Know list") to which the program would apply and that the list would be the "same" as the CEPP list. The EPA published the list as a proposed rule, and bacitracin and the phthalate esters were included. 51 Fed. Reg. 41,593 (1986).

 At the time that EPA published the proposed Right-to-Know list, it recognized that several of the listed substances "no longer [met] the original listing criteria" upon which both the CEPP and proposed Right-to-Know lists were based because of corrections to the RTECS data base. Id. EPA concurrently proposed, therefore, to delete these substances from the Right-to-Know list. Bacitracin and the phthalate esters were among the substances whose deletions were contemplated. Id. at 41,594.

 On April 22, 1987, EPA published a final rule promulgating the Right-to-Know list upon which reporting and planning requirements would be based. 52 Fed. Reg. 13,378 (1987). Although EPA admitted the inaccuracy of the list, id. at 13,388, it decided not to delete any substances at that time. Persuaded by some comments to the proposed deletion, the EPA reasoned that section 11002(a)(4) of the Right-to-Know Act *fn2" precludes removal of any substance from the list until the EPA has determined that the substances pose no short- or long-term health hazards as a result of short-term exposure. Since the criteria for making such a determination are not available, EPA assigned bacitracin and the phthalate esters to the "level of lowest concern." *fn3" Id. The EPA has taken no other action as to these substances but insists that it is "actively reviewing the data" and that a proposed decision as to bacitracin will be published soon.

 The Designation of Bacitracin as an Extremely Hazardous Substance

 Because of a clerical error, some data concerning bacitracin were incorrectly transcribed into the RTECS data base. The result of the error was to exaggerate the toxicity of bacitracin by a factor of more than 400. Relying on this overstated level of toxicity, the EPA included bacitracin on the CEPP list.

 Citing the RTECS error, A.L. Labs wrote the EPA's Office of Toxic Substances in January 1986 to request that the list be corrected. In addition, the RTECS data base was amended that month, and this correction was reported to EPA with supporting documentation in early 1986. Apparently, no further action was taken by A.L. Labs or EPA until Congress enacted SARA and EPA promulgated the Right-to-Know list of extremely hazardous substances.

 After the EPA declined to remove bacitracin from the Right-to-Know list, A.L. Labs petitioned the agency to have the deletion effected. At the same time, an RTECS official again notified EPA that the data base from which the CEPP and Right-to-Know lists were developed contained a clerical error regarding bacitracin. Subsequently, at a meeting between EPA and A.L. Labs representatives, the EPA acknowledged that bacitracin no longer qualified as an acutely toxic chemical but that section 11002(a)(4) precluded revision of the Right-to-Know list until the long-term toxic effects of bacitracin had been studied.

 Insisting that the EPA's actions have seriously harmed and will continue to harm the reputation of bacitracin, imposed inapposite regulatory burdens, and alarmed customers, A.L. Labs demands that the EPA be ...

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