AL Laboratories, Inc. v. EPA, Civ. A. No. 87-1991-OG
| Decision Date | 23 November 1987 |
| Docket Number | Civ. A. No. 87-1991-OG,87-2377-OG. |
| Citation | 674 F. Supp. 894 |
| Parties | A.L. LABORATORIES, INC., Plaintiff, v. ENVIRONMENTAL PROTECTION AGENCY, Defendant. CHEMICAL MANUFACTURERS ASSOCIATION, Plaintiff, v. Lee M. THOMAS, Administrator, United States Environmental Protection Agency, et al., Defendants. |
| Court | U.S. District Court — District of Columbia |
James Johnstone and Richard L. McConnell, Wiley, Rein & Fielding, Washington, D.C., for plaintiff A.L. Laboratories.
Robert Sussman and Scott Knudson, Latham & Watkins, Washington, D.C., for plaintiff Chemical Manufacturers Ass'n.
Caroline Wheling, E.P.A., and Daniel Pinkston, Dept. of Justice, Washington, D.C., for defendant EPA.
These consolidated cases arise from the Environmental Protection Agency's ("EPA") denomination of approximately 400 substances as "extremely hazardous." Plaintiffs manufacture or represent the manufacturers of some of these substances.1 The proximate effects of the appearance of a substance on this list include subjecting those who store sufficiently large quantities of the chemical to notification, reporting, and planning requirements under title III of the Superfund Amendments and Reauthorization Act ("SARA"). Pub.L. No. 99-499, §§ 300 et seq., 100 Stat. 1613, 1728 (1986) ("Right-to-Know Act") (codified at 42 U.S.C.S. §§ 11001-11050 (Law. Co-op. 1987)).
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.
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 Act2 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."3Id. 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.
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 ordered to remove bacitracin from the Right-to-Know list.
The Chemical Manufacturers Association ("CMA") is a trade organization that represents the interests of the industrial chemical industry before a variety of governmental bodies. Among the chemicals manufactured by its members are phthalate esters that have been included on the Right-to-Know list. Like bacitracin, the phthalate esters appear on that list based on data compiled in the RTECS data base. This data was derived from a Russian article that was incorrectly translated for use by RTECS. A correct translation revealed that the author of that article had merely copied data from an uncited source. That source, in turn, contained internal inconsistencies and used units of measurement which undermine the reliability of the source. Based on this reevaluation of the Russian article, RTECS deleted the Russian source from the data base, thereby eliminating any basis for classifying the phthalate esters as acutely toxic. In addition to notifying EPA of the error in the RTECS data base, CMA cited other sources that allegedly establish that the phthalate esters are not acutely toxic.
Apparently aware that the phthalate esters were erroneously included on the Right-to-Know list, EPA proposed to delete the substances, just as it had proposed to delete bacitracin. The esters fared no better than did bacitracin; when the EPA issued its final rule, the esters were not deleted from the list for the reasons explained above with respect to bacitracin.
CMA's fears concerning the delayed removal of the phthalate esters from the Right-to-Know list are similar to those recited by A.L. Labs: burdensome reporting and planning requirements and detriment to the reputation of the substances and the companies that manufacture them.
Plaintiffs have come to this Court seeking review of the EPA's decision not to remove bacitracin and the phthalate esters from the list of extremely hazardous substances promulgated under SARA. The material facts underlying the claims of A.L. Labs and the CMA are nearly identical, and the following discussion is equally applicable to bacitracin and the phthalate esters. The justiciability of the legal questions, however, is a preliminary matter raised by the agency.
While EPA admits the subject matter jurisdiction of this Court, it insists that under the Administrative Procedure Act ("APA"), 5 U.S.C.S. §§ 500-706 (Law.Co-op.1987), the decision to defer removal of bacitracin and the phalate esters from the Right-to-Know list is not ripe for judicial review. Section 704 of the APA permits judicial review only by express statutory authority or when agency action becomes "final." Id. § 704. The EPA insists that its action is not final because it is currently reviewing the toxicity of these chemicals and intends sometime in the future to decide "finally" whether the chemicals are acutely toxic.
The ripeness of an issue for judicial review turns on an intuitively obvious two-pronged test. The court must determine "the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration." Abbott Laboratories, Inc. v. Gardner, 387 U.S. 136, 149, 87 S.Ct. 1507, 1515, 18 L.Ed.2d 681 (1967). The goal of the analysis is to avoid judicial review of immature administrative decisions or policies. Id. at 148-49, 87 S.Ct. at 1515-16; see State Farm Mutual Automobile Insurance Co. v. Dole, 802 F.2d 474, 479 (D.C.Cir.1986) (), cert. denied, ___ U.S. ___, 107 S.Ct. 1616, 94 L.Ed.2d 800 (1987); Better Government...
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