Before ROBINSON and EDWARDS, Circuit Judges, and CORCORAN,* United States District Judge for the District of Columbia.
UNITED STATES COURT OF APPEALS, DISTRICT OF COLUMBIA CIRCUIT
MANUFACTURING COMPANY, EDISON ELECTRIC INSTITUTE, et al., AND ALUMINUM
COMPANY OF AMERICA, INTERVENORS 1980.CDC.267
On Petition for Review of Regulations Promulgated by the Administrator of the United States Environmental Protection Agency.
DECISION OF THE COURT DELIVERED BY THE HONORABLE JUDGE EDWARDS
In this case the Environmental Defense Fund petitions for review of regulations, issued by the U. S. Environmental Protection Agency , that implement section 6(e) of the Toxic Substances Control Act . *fn1 That section of the Act provides broad rules governing the disposal, marking, manufacture, processing, distribution, and use of a class of chemicals called polychlorinated biphenyls (PCBs). *fn2
EDF seeks review of three aspects of the regulations. *fn3 First, it challenges the determination by EPA that certain commercial uses of PCBs are "totally enclosed," a designation that exempts those uses from regulation under the Act. Second, it claims that the EPA acted contrary to law when it limited the applicability of the regulations to materials containing concentrations of PCBs greater than fifty parts per million (ppm). Third, EDF challenges the decision by EPA to authorize the continued use of eleven non-totally enclosed uses of PCBs.
From our examination of the record, we find that there is no substantial evidence to support the EPA determination to classify certain PCB uses as "totally enclosed." We also find that there is no substantial evidence in the record to support the EPA decision to exclude from regulation all materials containing concentrations of PCBs below fifty ppm. Accordingly, on these first two points, we hold unlawful and set aside the challenged regulations, and remand to EPA for further proceedings consistent with this opinion.
We find, however, that there is substantial evidence in the record to support the EPA determination to allow continued use of the eleven non-totally enclosed uses. Accordingly, on this third point, we uphold the EPA regulations. I. BACKGROUND
A. Polychlorinated Biphenyls
Polychlorinated biphenyls (PCBs) have been manufactured and used commercially for fifty years for their chemical stability, fire resistance, and electrical resistance properties. They are frequently used in electrical transformers and capacitors. However, PCBs are extremely toxic to humans and wildlife. The extent of their toxicity is made clear in the EPA Support Document *fn4 accompanying the final regulations, in which the EPA Office of Toxic Substances identified several adverse effects resulting from human and wildlife exposure to PCBs.
Epidemiological data and experiments on laboratory animals indicate that exposure to PCBs pose carcinogenic and other risks to humans. Experimental animals developed tumors after eating diets that included concentrations of PCBs as low as 100 parts per million (ppm). Experiments on monkeys indicate that diets with PCB concentrations of less than ten ppm reduce fertility and cause still births and birth defects. Other data show that PCBs may adversely affect enzyme production, thereby interfering with the treatment of diseases in humans. Support Document, supra note 4, at 9-18.
EPA has found that PCBs will adversely affect wildlife as well as humans. Concentrations below one ppb (part per billion) are believed to impair reproductivity of aquatic invertebrates and fish. Some birds suffered "severe reproductive failure" when fed diets containing concentrations of only ten ppm of PCBs. Id. at 19. Because PCBs collect in waterways and bioaccumulate in fish, *fn5 fish-eating mammals run a special risk of adverse effects. Such mammals may have "significantly higher concentrations of PCBs in their tissues than the aquatic forms they feed on." Id. at 36.
EPA estimates that by 1975 up to 400 million pounds of PCBs had entered the environment. Approximately twenty-five to thirty percent of this amount is considered "free," meaning that it is a direct source of contamination for wildlife and humans. The rest, "mostly in the form of industrial waste and discarded end use products, is believed to be in landfill sites and thus constitutes a potential source of new free PCBs." Id. at 33-34. *fn6 Other significant sources of PCBs include atmospheric fallout and spills associated with the use or transportation of PCBs. Id. at 29.
EPA concluded in the Support Document that "the additional release of PCBs" into the environment would result in widespread distribution of the PCBs and "will eventually expose large populations of wildlife and man to PCBs." Id. at 36-37. EPA concluded further that:
As a practical matter, it is not possible to determine a "safe" level of exposure to these chemicals. Because PCBs are already widely distributed throughout the biosphere, they currently pose a significant risk to the health of man as well as that of numerous other living things. As a consequence, any further increase in levels of PCBs in the biosphere is deemed undesirable by EPA.
Id. at 38. Because "PCBs released anywhere into the environment will eventually enter the biosphere ... EPA has determined that any such release of PCBs must be considered "significant.' " Id.
In 1972, Monsanto, the major American manufacturer of PCBs, limited its sales of PCBs to manufacturers of transformers and capacitors. It ceased all manufacture of PCBs in 1977 and shipped the last of its inventory before the end of that year. Today, PCBs are produced in this country only as incidental byproducts of industrial chemical processes. There are no known natural sources of PCBs. Id. at 2.
B. Congressional Response
Responding to the dangers associated with the use of PCBs and other toxic chemicals, Congress in 1976 enacted the Toxic Substances Control Act , Pub.L.No.94-469, 90 Stat. 2003 (1976). Although the Act is generally designed to cover the regulation of all chemical substances, section 6(e) refers solely to the disposal, manufacture, processing, distribution, and use of PCBs. No other section of the Act addresses the regulation of a single class of chemicals.
The special attention accorded to PCBs in the Toxic Substances Control Act resulted from the recognized seriousness of the threat that PCBs pose to the environment and human health. During the debate over the Senate version of the Act, Senator Nelson, the author of the amendment adding the PCB subsection to the Senate bill, noted that PCBs were widespread in the environment and that they posed significant potential dangers to human health and to wildlife. *fn7 In the House of Representatives, Congressman Dingell introduced a similar amendment to the House version of the Toxic Substances Control Act, *fn8 not only because PCBs posed great dangers to the natural and human environments, but also because "the history of EPA is not one of vigorous and quick action." *fn9
As enacted, section 6(e) of the Act *fn10 sets forth a detailed scheme to dispose of PCBs, to phase out the manufacture, processing, and distribution of PCBs, and to limit the use of PCBs. Specifically, section 6(e) provides that, within six months of the effective date of the Act (January 1, 1977), EPA must prescribe methods to dispose of PCBs and to require that PCB containers be marked with appropriate warnings. 15 U.S.C. § 2605(e)(1). One year after the effective date of the Act, PCBs can be manufactured, processed, distributed, and used only in a "totally enclosed manner." Id. § 2605(e)(2). One year later, all manufacture of PCBs is prohibited. Id. § 2605(e)(3)(i). Six months after that (i. e. two and one-half years after the effective date of the Act), all processing and distribution of PCBs in commerce is prohibited. Id. § 2605(e)(3)(ii). Thus, today, except for the specified authorizations and exemptions described below, the Act permits PCBs to be used only in a totally enclosed manner, and it completely prohibits the manufacture, processing, and distribution of PCBs.
The statute sets forth only limited exceptions to these broad prohibitions. Subsection 6(e)(2)allows the Administrator of EPA to authorize by rule the continued use of PCBs in a non-totally enclosed manner if he finds that the proposed activity "will not present an unreasonable risk of injury to health or the environment." Id. 2605(e)(2). *fn11 Under subsection 6(e)(3), the Administrator may grant a case-by-case exemption to the prohibitions on manufacture, processing, and distribution of PCBs in subsection 6(e)(3). An exemption, which may be granted for one year subject to conditions set by the Administrator, id. § 2605(e)(3), must be based on the Administrator's findings that "an unreasonable risk of injury to health or environment would not result, and ... good faith efforts have been made to develop a chemical (substitute) which does not present an unreasonable risk of injury to health or the environment." Id. (emphasis added).
C. EPA's Implementation of section 6(e)
EPA sought to implement section 6(e) through two sets of regulations. The first set of regulations the so-called Disposal Regulations set forth specific rules governing the disposal and marking of PCBs. The Disposal Regulations covered not only pure PCB compounds, but also materials contaminated with at least 500 ppm of PCBs. EPA chose this regulatory cutoff in order to regulate "disposal of most PCB's ... as soon as possible." Preamble to Final Disposal Regulations, 43 Fed.Reg. 7,151 (1978). EPA warned that it was considering a new cutoff "possibly in the range of 50 ppm or below" for the Proposed Ban Regulations. Id.
In June 1978 EPA issued proposed Ban Regulations that would implement the prohibitions mandated in subsections 6(e)(2) and (3), define "totally enclosed manner," authorize several non-totally enclosed uses, and set forth the procedures for obtaining exemptions from the prohibitions. See Proposed Ban Regulations, 43 Fed.Reg. 24,801 (1978). As foreshadowed in the final Disposal Regulations, the proposed and final Ban Regulations (issued May 31, 1979) set fifty ppm as the cutoff. See 43 Fed.Reg. 24,813 (1978), 44 Fed.Reg. 31,543 (1979) (to be codified in 40 C.F.R. § 761.1(b)). The final regulations defined all electrical capacitors, electromagnets, and non-railroad transformers as totally enclosed, *fn12 thus automatically exempting them from regulation under the Act. In the final regulations the Administrator authorized eleven non-totally enclosed uses to continue, including the servicing of totally enclosed uses, *fn13 based on his consideration of the health and environmental effects of PCBs, the exposure to PCBs resulting from these activities, the availability of substitutes for the ...