Nos. 77-1091, 77-1317 and 77-1462.United States Court of Appeals, District of Columbia Circuit.Argued March 24, 1978.
Decided November 3, 1978. Rehearing Denied December 14, 1978. Rehearing Denied in No. 77-1462 December 14, 1978.
Page 63
[EDITORS’ NOTE: THIS PAGE CONTAINS HEADNOTES. HEADNOTES ARE NOT AN OFFICIAL PRODUCT OF THE COURT, THEREFORE THEY ARE NOT DISPLAYED.]Page 64
Jacqueline M. Warren, Washington, D.C., with whom John F. Hellegers and William A. Butler, Washington, D.C., were on the brief, for petitioner in No. 77 1091.
Peter J. Nickles, Washington, D.C., with whom Steven S. Rosenthal, John Michael Clear, and Roger E. Wills, Jr., were on the brief, for petitioners in No. 77 1317.
Andrew Robert Greene, Atlanta, Ga., with whom Henry Angel, Atlanta, Ga., was on the brief, for petitioner in No. 77-1462.
Lorraine Chang, Atty., Environmental Protection Agency, Washington, D.C., with whom Ridgway M. Hall, Jr., Associate Gen. Counsel, Environmental Protection Agency, James W. Moorman, Acting Asst. Atty. Gen., and Douglas K. Miller, Atty., Dept. of Justice, Washington, D.C., were on the brief, for respondents. Peter R. Taft and William L. Want, Attys., Dept. of Justice, Washington, D.C., also entered appearances for respondents.
Petitions for Review of Orders of the Environmental Protection Agency.
Page 65
Before TAMM and ROBINSON, Circuit Judges, and CHARLES R. RICHEY,[*] United States District Judge for the District of Columbia.
Opinion for the court filed by TAMM, Circuit Judge.
TAMM, Circuit Judge:
[1] We are called upon in these consolidated cases to review challenges to the Environmental Protection Agency’s (EPA) first regulations prohibiting discharge into the nation’s waterways of a toxic substance, polychlorinated biphenyls (PCBs), under the Federal Water Pollution Control Act Amendments.[1] For the reasons that follow, we uphold the EPA’s regulations. [2] This section was amended by section 53 of the Clean Water Act of 1977, 33 U.S.C.A. § 1317(a) (1977); see text at ___-___, ___-___ of ___ U.S.App.D.C., at 71, 73-74 of 598 F.2d infra. See also Hercules, Inc. v. EPA, (D.C. Cir. 1978), ___ U.S.App.D.C. ___ at ___-___, 598 F.2d 91 at 100-102; Federal Water Pollution Control Act Amendments of 1972 (1972 Act or the Act), 33 U.S.C. §§ 1251–1376 (1976). [3] I. FACTS AND PRIOR PROCEEDINGS.[4] A. Factual Background on PCBs.[5] PCBs are a group of related chlorinated hydrocarbon chemicals useful in several industrial processes and toxic to a wide variety of organisms, including man. The chemistry of PCBs figures prominently in this case and will be discussed below. At this point, we need note only that PCBs fall into two chemical categories: PCBs with a low
Page 66
chlorine content (less chlorinated PCBs) and PCBs with a high chlorine content (more chlorinated PCBs). More chlorinated PCBs have been manufactured and used since 1929. For decades, they served in a variety of industrial uses such as ink solvents, plasticizers, adhesives, and textile coatings,[2] but their principal use was and is in electrical equipment. PCBs are nonflammable liquids that are highly resistant to electrical current. Therefore, they have been widely used to fill electrical devices such as capacitors and transformers, aiding in the storage of electrical charge without creating the fire hazard that would occur if a flammable filler were used.
[6] Awareness of the danger from PCBs to the environment and to man was slow to develop. Although large quantities of PCBs were manufactured and leaked into the environment, the PCBs detected in the environment were long mistaken for pesticide residues, which they resemble chemically. It was not until the mid-1960’s that the presence of PCBs in the environment and the harm they inflict were recognized and distinguished from the pesticide problem.[3] As we shall discuss below, it became apparent from scientific studies that more chlorinated PCBs built up to dangerous levels in the sediments of waterways, in the water, in fish, and ultimately in humans, creating a serious risk of death for aquatic organisms and disease (particularly cancer) for man. [7] In 1971-72, in response to public and government pressure, PCBs manufacturers and users took initial steps to reduce the PCBs danger.[4] Manufacture was shifted from the more chlorinated PCBs to the less chlorinated PCBs, because it was hoped that less chlorinated PCBs were less dangerous. PCBs use was limited to closed electrical equipment, where the need was greatest and the leakage was least. Some effort was made to control discharge of PCBs into waterways. [8] However, in 1972-74 manufacturers were curtailing their efforts to find acceptable substitutes for PCBs,[5] and manufacture of less chlorinated PCBs continued at high volumes, e.g., forty million pounds in 1974. 42 Fed.Reg. 6533 (1977). EPA’s initial effort to control discharge of PCBs into waterways, the precursor of the proceeding now on review, ended in failure in 1973-74.[6] Discharges of PCBs into the nation’s waterways continued. [9] Developments in the early and mid-1970’s heightened the public concern about PCBs and resulted in new regulatory efforts in late 1975 and early 1976. Monitoring of residues in fish revealed that industrial discharges of PCBs were rendering fish in many waterways unhealthy for human consumption.[7] This monitoring culminated inPage 67
a state proceeding, General Electric Co., 6 Envir.L.Rep. (Envir. Law Inst.) 30007 (1976), in which New York’s Department of Environmental Conservation found that discharges of PCBs by General Electric, a major manufacturer of electrical equipment containing PCBs, had rendered most upper Hudson River fish dangerous to eat. Id. at 30017-18. Similar situations threatened the fishing industry in the Great Lakes and elsewhere.
[10] While the General Electric case was pending, a national conference on PCBs hazards was held in November 1975 that resulted in greater awareness of the nationwide threat posed by PCBs and contributed to the renewed EPA effort to regulate and control PCBs discharges.[8] The EPA regulations now on review are the culmination of that effort. [11] Following the 1975 renewal of EPA’s regulatory effort, further information accumulated with respect to the health hazards posed by PCBs. Moreover, substitutes for PCBs were developed in this country and in Japan that would serve adequately in electrical equipment without creating a fire hazard.[9] Congress became impatient and wrote a special provision devoted solely to PCBs into the Toxic Substances Control Act of 1976, 15 U.S.C. §§ 2601–2629 (1976). See section 6(e), 15 U.S.C. § 2605(e) (1976). Considering that there are few statutes aimed so particularly at control of an individual chemical, we construe this provision as a significant comment on the failure of existing regulatory mechanisms.[10] Failure of existing regulatory mechanisms to control PCBs contributed materially both to passage of the preventive sections of the Toxic Substances Control Act and to strengthening, in 1977, of the toxics provision of Federal Water Pollution Control Act Amendments of 1972. See 33 U.S.C.A. § 1317(a) (1977).[11] [12] Further, the failures in initial efforts at controlling PCBs were a major factor in new administrative initiatives. During the late 1960’s and early 1970’s, the Food and Drug Administration,[12] the OccupationalPage 68
Safety and Health Administration,[13] and EPA had made independent efforts to control PCBs, none of them wholly successful. This lack of success stimulated a new effort at interagency cooperation in toxics regulation, and was a major factor in the development of EPA’s large-scale program for regulation of discharges of toxic substances, including PCBs.[14]
[13] B. PCBs Proceedings.[14] We set forth the history of EPA’s PCBs proceedings in detail because it bears on both the posture of this appeal and the interpretation of the statutes that Congress passed in 1976 and 1977. In sum, the history of EPA’s PCBs proceedings is a history of frustration of a congressional mandate for action. Regulatory steps that Congress expected to take little more than one year took four years. [15] On October 18, 1972, Congress enacted the Federal Water Pollution Control Act Amendments of 1972 (1972 Act or the Act), 33 U.S.C. §§ 1251–1376 (1976). The 1972 Act prescribed a rigid schedule for promulgation of effluent standards for toxic substances. Section 307(a), 33 U.S.C. § 1317(a) (1976),[15]
directed EPA to publish a list of toxic substances within ninety days, propose effluent standards for the listed substances within 180 days after listing, and promulgate final effluent standards within six months after the proposed standards. Thus, EPA was to promulgate toxic effluent regulations by early 1974. [16] In May 1973, after EPA failed to meet its first deadline, the Natural Resources Defense Council, Inc. (NRDC) sued EPA to hasten EPA action and bring about publication of a toxic substances list. This suit ended in a consent decree in June 1973, fixing a timetable for EPA. NRDC v. Fri, 3 Envir.L.Rep. (Envir. Law Inst.) 20587 (D.D.C. 1973). Pursuant to this timetable, EPA issued, in July 1973, a proposed list of nine toxic substances, including PCBs, 38 Fed.Reg. 18044 (1973), and, in September 1973, a final list of the same nine substances. 38 Fed.Reg. 24342
(1973). In December 1973, EPA proposed standards for the nine substances. 38 Fed.Reg. 35388 (1973).[16] In April and May 1974, EPA held an evidentiary hearing on the proposed standards in which numerous objecting parties participated. [17] However, after the hearing, EPA failed to promulgate final standards for any of the nine substances. There were several causes for this failure. EPA contended that it lacked sufficient data to set regulations that would survive judicial review.[17]
Congressmen later expressed their belief
Page 69
that the procedures employed by EPA substantially impeded effective regulation due to their excessive complexity and formality.[18] Finally, EPA experienced difficulty in responding to the many concerns raised by industry representatives at the hearing. Some of those concerns had little bearing on regulation,[19] but others were weighty.[20]
[18] EPA’s failure to promulgate any toxic standards triggered a waive of suits by environmental groups seeking to compel EPA to promulgate regulations for PCBs and other toxic substances.[21]Before those suits could be resolved, EPA developed a new approach to toxics regulation, and negotiated a consent decree with the environmental groups that was accepted, with modifications in June 1976, by the United States District Court for the District of Columbia. NRDC v. Train, 8 ERC (BNA) 2120, 2122 (1976) (“Flannery decree”), rev’d
Page 70
in part on other grounds sub nom. NRDC v. Costle,
183 U.S.App.D.C. 11, 561 F.2d 904 (1977). EPA’s new approach had two elements. First, EPA committed itself to controlling toxic substances under provisions of the 1972 Act other than section 307(a), chiefly sections 301 and 304, 33 U.S.C. §§ 1311 1314
(1976), which allowed EPA to regulate on an industry-by-industry basis using informal rulemaking proceedings and feasibility criteria. Second, EPA committed itself to make at least limited use of section 307(a): it would regulate some substances, including PCBs, under the provision; and it would use the provision to limit or prohibit discharges of hazardous substances for some or all industrial categories as a supplement to its industry-by-industry approach.[22]
(1977). The final standards were more stringent than the proposed standards in that they prohibited any PCBs in discharges of manufacturers of electrical equipment.
Page 71
[23] On January 19, 1977, EDF petitioned this court for review of the regulations. On January 20, industry petitioners petitioned the United States Court of Appeals for the Third Circuit, and, on April 15, the Bass Anglers Sportsman Society of America petitioned the United States Court of Appeals for the Fifth Circuit. The petitions in the Third and Fifth Circuits were transferred to this court, and the cases were consolidated. A motion by industry petitioners for a stay of the regulations was denied by this court. On December 27, 1977, during the pendency of this appeal, Congress enacted the Clean Water Act of 1977, Pub.L. No. 95-217, 91 Stat. 1566, which amended the 1972 Act. Compliance with the PCBs regulations was required by February 2, 1978. 42 Fed.Reg. 6555.[24] II. STATUTORY FRAMEWORK.
[25] The earliest version of the Federal Water Pollution Control Act was passed in 1948, and it was amended five times prior to 1972 See W. Rodgers, Environmental Law 355-61 (1977). Congress overhauled it completely in the Federal Water Pollution Control Act Amendments of 1972. This “statute, enacted on October 18, 1972, authorized a series of steps to be taken to achieve the goal of eliminating all discharges of pollutants into the Nation’s waters by 1985, § 101(a)(1).” E. I. du Pont de Nemours Co. v. Train, 430 U.S. 112, 116, 97 S.Ct. 965, 969, 51 L.Ed.2d 204 (1977). The steps to be taken included promulgation by EPA of effluent standards, or regulations limiting discharges of various kinds of pollutants, under a number of statutory provisions covering industrial sources, municipal sources, sources that discharge into public treatment facilities (pretreatment standards), and sources that discharge toxic pollutants. See W. Rodgers, supra, at 451-88.
Page 72
[27] Prior to 1972, there was no special provision in the federal water pollution laws to cope with toxic pollutants. As the number and amount of chemicals discharged into the nation’s waterways increased in recent decades, it became apparent that some groups of chemicals posed a special danger to public health and the environment. There were two leading examples of such groups: chlorinated hydrocarbons, a group that included both pesticides (such as DDT, endrin, and toxaphene) and industrial chemicals (such as PCBs); and heavy metals, a group that included cadmium, mercury, and others.[30] [28] Toxic substances, such as these, create a special danger in several ways. As demonstrated by a number of disasters involving widespread human poisoning or massive kills or contamination of fish, shellfish, birds, and other wildlife, many chemicals discharged into waters are lethal or injurious even in minute doses.[31] Toxic chemicals have been identified repeatedly as a cause of cancer, through studies both of persons exposed to such chemicals on the job and elsewhere, and of animals in the laboratory and the field.[32] Moreover, toxic substances often have characteristics besides toxicity that magnify their danger. These characteristics include (1) physical and chemical factors such as resistance to detoxification by sunlight and water, and mobility in the air and water; and (2) biological factors, such as tendencies not to be safely degraded by organisms, but rather to accumulate in organisms or to degrade into other toxic substances. Finally a most troubling characteristic of toxic substances is how littlePage 73
they are understood by scientists. New discoveries about their nature and effects are made constantly, but existing knowledge seems inadequate to measure their full danger.[33]
[29] Congress’s response to the toxics problem was section 307 of the 1972 Act. Other interlocking sections gave prominence to section 307. Section 101(a)(3) of the Act, 33 U.S.C. § 1251(a)(3) (1976), stated that “it is the national policy that the discharge of toxic pollutants in toxic amounts be prohibited.” Section 502(13), 33 U.S.C. § 1362(13) (1976), gave a broad definition[34] to “toxic pollutant,” drawing on the wide array of direct and indirect effects of such substances. Other provisions established that citizen suits for violations of section 307 were free from certain procedural requirements of other citizen suits,[35] that section 307 standards were to become effective quickly,[36] and that section 307 standards were to be reviewed at least every three years.[37] The 1977 amendments to the Act continued this highlighting tendency, by declaring that toxic pollutant standards are not subject to individual waiver or modification as are other standards.[38] [30] Section 307(a) sets forth the substantive considerations and procedures for EPA to use in formulating toxics standards. In the substantive provisions, section 307(a)(2) requires EPA to “take into account” six factors that were intended to cover comprehensively the effects of toxic substances in the environment. Section 307(a)(5) allows EPA to set different standards for industrial categories using different processes. Section 307(a)(4) directs EPA to set the standards at a level that provides “an ample margin of safety,” a phrase that is the section’s polestar — its guiding principle in protecting against incompletely understood dangers. [31] More complex than the section’s substantive provisions are its procedural provisions,Page 74
which mingle formal with informal rulemaking. As discussed previously, the statute prescribed mandatory deadlines for listing of toxic substances, proposal of standards, and promulgation of standards. The basic mechanism was informal rulemaking. However, following the arrangement of section 112 of the Clean Air Act, see note 28 supra, Congress grafted an added procedural limb to the body of the provision. A hearing was to be held, and a finding concerning whether a modification of a proposed effluent standard was justified was to be made “on the record” of that hearing.[39]
[32] In the Clean Water Act of 1977, Congress amended the toxics provision in major part to solve the problems revealed in the course of the 1973-76 proceedings. Congress adopted its own list of sixty-five families of toxic substances in place of EPA’s older, shorter lists,[40] and created two procedures for EPA to use, separately or in tandem. Under the first procedure, amended section 307(a)(2), 33 U.S.C.A. § 1317(a)(2) (1977), directed EPA to set industry-by-industry regulations based on technological feasibility criteria.[41] Under the second procedure, which was based on the 1972 provision, amended section 307(a)(2) directed EPA to set health-based effluent standards on a pollutant-by-pollutant basis using the original factors of toxicity, persistence, degradability etc., and the familiar “ample margin of safety” standard.[42] The original cumbersome procedures were relaxed: formal procedures were replaced by informal ones, and the timetable for rulemaking was enlarged.[43][33] III. PROCEDURAL CHALLENGES.
[34] Industry petitioners raise two challenges to the PCBs regulations on procedural grounds. First, they contend that the EPA judicial officers assisting the Administrator in preparing the decision improperly relied on the EPA staff members who were advocates for the regulations. This contention is based on both the fact of contacts between staff advocates and judicial officers,[44] and the close similarity between the findings and conclusions proposed by the staff advocates and the final decision.[45] This contention is identical to one raised i Hercules, Inc. v. EPA, (1978), 194 U.S.App.D.C. ___ at ___-___, 598 F.2d 91 at 119 128, decided today; and we reject it for the reasons stated therein.
Page 75
in Hercules, and so we address it in somewhat more detail than the first contention. In the PCBs proceeding, EPA assigned Mr. John Settle, an attorney in the Grants, Contracts and Administration Division of EPA’s Office of General Counsel,[46] to act as a special judicial officer and, in that role, to assist the agency’s chief judicial officer in preparing the final decision under the Administrator’s supervision.
[36] Under section 5(d)(2) of the Administrative Procedure Act (APA), 5 U.S.C. § 554(d)(2) (1976), in agency adjudication, an agency employee who makes an initial or recommended decision may not “be responsible to or subject to the supervision or direction of an employee or agent engaged in the performance of investigative or prosecuting functions for an agency.”[47] EPA staff who advocated the proposed rules before the agency are also employees of a Division in the Office of the General Counsel.[48] By analogy to section 5(d) of the APA, which applies only to adjudication, industry petitioners allege that Mr. Settle’s assistance in preparing the Administrator’s final decision requires that the regulations be vacated and remanded.[49] We disagree. [37] The proceedings in this case were clearly rulemaking proceedings. See Hercules, Inc. v. EPA,194 U.S.App.D.C. at ___-___, 598 F.2d at 117-119. Congress was of the view that the APA’s separation of functions provision, section 5(d), should not apply to rulemaking proceedings, and its failure to make the provision applicable to rulemaking was intentional.[50] In Congress’s view, the need for flexibility in rulemaking outweighed the advantages of rigid staff divisions. [38] There is no contention that Mr. Settle was involved in any way in the rulemaking proceedings in question prior to his assignment to assist the Administrator.[51] Moreover, there is no contention that anyone in the Office of General Counsel placed improper
Page 76
pressure upon him in his capacity as acting judicial officer.[52]
[39] Industry petitioners contend “there is an obvious risk that an individual placed in this position might be easily swayed, consciously or subconsciously, by the possibility that a decision adverse to his superior would adversely affect his career prospects.”[53] However, to the extent that there may be such a risk, or an appearance of such a risk, Congress found that the benefits of protecting against it outweighed the countervailing inefficiency created by rigid staff division only in adjudicatory proceedings, not rulemaking. In the absence of any contention by petitioners that Mr. Settle was improperly influenced, we reject their allegation that his participation in the preparation of the final decision tainted the regulations.[40] IV. INTERACTION WITH TOXIC SUBSTANCES CONTROL ACT.
[41] Congress enacted the Toxic Substances Control Act (TSCA), 15 U.S.C. §§ 2601–2629 (1976), during the pendency of EPA’s proceedings on the proposed PCBs effluent standards. TSCA requires notice of intent to manufacture, and pre-manufacture testing of chemical substances, and confers authority on EPA to regulate the manufacture, processing, distribution in commerce, use, or disposal of such substances. In addition to the provisions applicable to chemical substances in general, TSCA includes a specific provision concerned solely with polychlorinated biphenyls, section 6(e), 15 U.S.C. § 2605(e) (1976). Section 6(e) provides for a gradual phasing out of PCBs use over a two and one-half year period with limited provision for exemptions.[54]
rather than a claim of “preemption.” “It is, of course, a cardinal principle of statutory construction that repeals by implication are not favored.” United States v. United Continental Tuna Corp., 425 U.S. 164, 168-69, 96 S.Ct. 1319, 1323, 47 L.Ed.2d 653 (1976) (collecting cases). “Implied repeals occur if two Acts are in irreconcilable conflict.” Runyon v. McCrary, 427 U.S. 160, 172-73 n. 10, 96 S.Ct. 2586, 2595, 49 L.Ed.2d 415 (1976) (emphasis
Page 77
added). When confronted with statutes that are “capable of co-existence, it is the duty of the courts, absent a clearly expressed congressional intention to the contrary, to regard each as effective.” Regional Rail Reorganization Act Cases, 419 U.S. 102, 133-34, 95 S.Ct. 335, 353, 42 L.Ed.2d 320
(1974) (quoting Morton v. Mancari, 417 U.S. 535, 551, 94 S.Ct. 2474, 41 L.Ed.2d 290 (1974)).
[45] Section 9(b) leaves EPA the choice of regulating toxic substances under TSCA, other statutes (such as the 1972 Act), or both. Throughout debate over passage of TSCA, representatives of the chemical industry urged that it would be unnecessarily duplicative of existing authority, and that EPA should not be given a choice among multiple regulatory authorities.[56]If the Administrator determines that a risk to health or the environment associated with a chemical substance or mixture could be eliminated or reduced
to a sufficient extent by actions taken under the authorities contained in . . . other Federal laws, the Administrator shall use such authorities to protect against such risk unless the Administrator determines, in the Administrator’s discretion, that it is in the public interest to protect against such risk by actions taken under this chapter. This subsection shall not be construed to relieve the Administrator of any requirement imposed on the Administrator by such other Federal laws.
Congress rejected those arguments, which petitioners, in effect, now seek to resurrect. Congress determined that a choice among regulatory authorities was necessary so that EPA could use the most effective means available to combat unknown and potentially extreme risks from toxic substances, and that judicial review of EPA’s choice was inappropriate.[57] Our interpretation of section 9(b) is reinforced by section 6(e)(5), 15 U.S.C. § 2605(e)(5) (1976), which states: “[t]his subsection [6(e) (governing PCBs)] does not limit the authority of the Administrator, under any other provision of this chapter or any other Federal law, to take action respecting any polychlorinated biphenyl.” [46] Petitioners contend it is incongruous that EPA can take action concerning PCBs under section 307 that they contend, Congress did not subsequently authorize under TSCA.[58] However, the provision of multiple
Page 78
regulatory authorities is far from unknown. Indeed, the Supreme Court recently noted, concerning civil rights legislation, that “legislative enactments in this area have long evinced a general intent to accord parallel or overlapping remedies against discrimination.” Alexander v. Gardner-Denver Co., 415 U.S. 36, 47, 94 S.Ct. 1011, 1019, 39 L.Ed.2d 147 (1974). Legislative enactments concerning dangerous substances evince a similar intent. In EDF v. Department of Health, Education and Welfare, 138 U.S.App.D.C. 381, 428 F.2d 1083 (1970), this court held that Congress had not intended, by passage of the Federal Insecticide, Fungicide and Rodenticide Act, to limit authority to regulate pesticide residues in food under the Federal Food, Drug and Cosmetic Act. Id.
138 U.S.App.D.C. 384-86, 428 F.2d at 1086-88. Similarly, in Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966), the court held that Congress had not intended by passage of the Poultry Products Inspection Act, to limit authority to regulate drug residues in poultry under the Federal Food, Drug and Cosmetic Act. Accordingly, we find no merit in the argument that TSCA was intended to constrain EPA’s authority under the 1972 Act.
[47] V. EVIDENTIARY BASIS FOR REGULATION OF LESS CHLORINATED PCBs.[48] A. Arguments of the Parties.
[49] The principal claim of industry petitioners is that EPA’s regulations lack an adequate basis in the record to the extent that they cover less chlorinated PCBs because the record consists, in large part, of studies of related, but different substances (more chlorinated PCBs). In order to rule on this claim, we have no alternative except to venture into a difficult realm of chemistry and toxicology, for, however deferential may be our review, we cannot rule on an issue without a firm grasp of it.[59]
Page 79
until the early 1970’s.[64] In the early 1970’s, under public and government pressure, PCBs manufacturers and users shifted from more chlorinated to less chlorinated PCBs.[65]
The chemical and electrical industries were able to shift relatively rapidly from use of one PCBs mixture to another. However, this shift created the “knowledge gap” that underlies the principal issue in this proceeding. As a practical matter, scientific knowledge about the effects of chemicals cannot keep up with the ability of industrial laboratories to create new ones. Most of the available scientific studies on PCBs concern more chlorinated PCBs, either because the studies were conducted over the decades when more chlorinated PCBs were the main PCBs in use, or because, even after the early 1970’s, scientists continued to study the more chlorinated PCBs.[66]
[57] Section 307(a)(2) sets forth the relevant factors for setting toxic effluent standards.
Page 80
It requires EPA to “take into account” six factors in proposing such standards: “the toxicity of the pollutant, its persistence, degradability, the usual or potential presence of the affected organisms in any waters, the importance of the affected organisms and the nature and extent of the effect of the toxic pollutant on such organisms.”
[58] The six factors consist of two groups. The first three factors, toxicity, persistence, and degradability, constitute a carefully drafted tripartite division of the relationship between a toxic substance and the environment. Toxicity concerns the adverse biological effects of toxic substances on life in the environment.[67] Persistence concerns the physical and chemical effects of the nonliving environment (such as sunlight and water) on toxic substances.[68] Degradability concerns the effects of the living environment on toxic substances.[69] Taken together, the three factors were intended to cover comprehensively the fate of toxic substances in the environment and their effects on living organisms.[70] [59] The last three factors concern “affected organisms”: their presence (usual or potential) “in any waters,” their importance, and the effect on them of the toxic substance. Inclusion of these factors requires EPA to focus on specific effects on specific important organisms as well as on the general toxicity, persistence, and degradability of the substance. On the list of “affected organisms” is, of course, man,[71] although other organisms may certainly trigger the last three factors. [60] Based on these factors, section 307(a)(4) directs EPA to set discharge standards at a level providing an “ample margin of safety.” The parties dispute the significance of this important subsection. EPA argues that this subsection gives it latitude to protect against risks that are incompletely understood, in essence to “err” on the side of “overprotection” with respect to known risks in order to provide safety from unknown dangers. Industry petitioners disagree. [61] On examination of the wording of the statute and the legislative background, we find ourselves in agreement with EPA, whose interpretation of the complex statutes it administers is, of course, entitled to some deference. E. I. du Pont de Nemours Co. v. Train, 430 U.S. 112, 134-35, 97 S.Ct. 965, 51 L.Ed.2d 204 (1977); Union Electric Co. v. EPA, 427 U.S. 246, 256, 96 S.Ct. 2518, 49 L.Ed.2d 474 (1976); Train v. NRDC, 421 U.S. 60, 75, 87, 95 S.Ct. 1470, 43 L.Ed.2d 731 (1975). Despite the problems associated with estimating the scale of incompletely understood dangers, Congress required EPA to set standards that would protect against them. [62] The “ample margin of safety” standard was taken originally from technical jargonPage 81
for use in section 112 of the Clean Air Act Amendments of 1970, the hazardous pollutants provision. See note 28 supra. One academic commentator has traced the history of the use of this term:
The term [margin of safety] seems to have been borrowed in the first instance from the field of engineering. It is a common engineering practice to incorporate a factor of safety into the design of a structure to “ensure that under full working loads the stress will nowhere exceed a safe working limit.” The safety factor is meant to compensate for uncertainties and variabilities in design, materials workmanship, and so forth; the greater the variability, the larger the factor of safety.
That the use of the term “margin of safety” in section 307(a) was similarly meant by Congress to take into account and compensate for uncertainties and lack of precise predictions in the area of forecasting the effects of toxic pollutants is confirmed by reference to the Clean Air Act. FWPCA section 307(a) is very similar to section 112 of the Clean Air Act. Among the similarities is the requirement in both that any standard set should provide “an ample margin of safety.”
. . . . .
[63] Hall, The Control of Toxic Pollutants Under the Federal Water Pollution Control Act Amendments of 1972, 63 Iowa L.Rev. 609, 629 30 (1978) (footnotes omitted) (emphasis in original). The foregoing analysis demonstrates that the term “margin of safety” was intended to provide protection “against hazards which research has not yet identified.”[72] Moreover, the public and the environment were not to be exposed to anything resembling the maximum risk. Not only was EPA to provide a “margin of safety,” but the margin was to be greater than “normal” or “adequate”: the margin was to be “ample.” If administrative responsibility to protect against unknown dangers presents a difficult task, indeed, a veritable paradox — calling as it does for knowledge of that which is unknown — then, the term “margin of safety” is Congress’s directive that means be found to carry out the task and to reconcile the paradox. Addition of a generous measure — “ample” — is Congress’s recognition that the EPA would need great latitude in meeting its responsibility.[73]Congress . . . provided in section 307(a) of the FWPCA, as in section 112 of the Clean Air Act, that the “margin of safety” be “ample.” This is in contrast to the requirement of section 109 of the Clean Air Act that primary air standards assure an “adequate margin of safety”; the requirement of the Safe Drinking Water Act that contaminant levels for public water supplies be set at a level to assure “an adequate margin of safety”; or the requirement of section 303(d)(1)(C) of the [1972 Act] that waste load allocations be established at simply “a margin of safety.”
“Ample” is defined as “abundant; plentiful; more than adequate.” Clearly Congress intended that in dealing with toxic pollutants that pose a threat to human health, margins of safety should be generous to ensure protection of human health and aquatic ecosystems to the greatest extent possible.
Page 82
[64] C. Scope of Review.[65] EPA’s decision is reviewed under the “substantial evidence” test. Three leading Supreme Court opinions have elaborated the nature of the “substantial evidence” test in review of nonscientific adjudications. In Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229, 59 S.Ct. 206, 217, 83 L.Ed. 126 (1938), Chief Justice Hughes described “substantial evidence” as “more than a mere scintilla. It means such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.” In Universal Camera Corp. v. NLRB, 340 U.S. 474, 488, 71 S.Ct. 456, 465, 95 L.Ed. 456 (1951), the Supreme Court instructed that under this standard, “[a] court may [not] displace the [agency’s] choice between two fairly conflicting views, even though the court would justifiably have made a different choice had the matter been before it de novo.” I Consolo v. FMC, 383 U.S. 607, 620, 86 S.Ct. 1018, 1026, 16 L.Ed.2d 131 (1966), the Court added that the standard of “substantial evidence” means “something less than the weight of the evidence, and the possibility of drawing two inconsistent conclusions from the evidence does not prevent an administrative agency’s finding from being supported by substantial evidence.” [66] Recent lower court decisions have elucidated a significant aspect of the “substantial evidence” test in review of scientific rulemaking. Recently, in Industrial Union Department, AFL-CIO v. Hodgson, 162 U.S.App.D.C. 331, 499 F.2d 467 (1974) (cited with approval, FCC v. National Citizens Committee for Broadcasting, 436 U.S. 775, 814, 98 S.Ct. 2096, 56 L.Ed.2d 697 (1978) ), this court construed a section of the Occupational Safety and Health Act of 1970 that provides for judicial review of rulemaking under the “substantial evidence” test. The court distinguished between those administrative determinations that were “factual”, and those that were “legislative” i.e., involved policy judgments:
[67] 162 U.S.App.D.C. at 338-39, 499 F.2d at 474-75 (footnotes omitted) (emphasis added). The central conclusion of Industrial Union — when an agency must resolve issues “on the frontiers of scientific knowledge,” the reviewing court will uphold agency conclusions based on policy judgments in lieu of factual determinations — has gained acceptance in many statutory contexts. See, e.g., American Iron SteelThe Secretary’s task thus contains “elements of both a legislative policy determination and an adjudicative resolution of disputed facts.” Mobil Oil Corp. v. FPC, 157 U.S.App.D.C. 235, 254, 483 F.2d 1238, 1257 (1973). Although in practice these elements may so intertwine as to be virtually inseparable, they are conceptually distinct and can only be regarded as such by a reviewing court.
From extensive and often conflicting evidence, the Secretary in this case made numerous factual determinations. With respect to some of those questions, the evidence was such that the task consisted primarily of evaluating the data and drawing conclusions from it. The court can review that data in the record and determine whether it reflects substantial support for the Secretary’s findings. But some of the questions involved in the promulgation of these standards are on the frontiers of scientific knowledge, and consequently as to them insufficient data is presently available to make a fully informed factual determination. Decision making must in that circumstance depend to a greater extent upon policy judgments and less upon purely factual analysis. Thus, in addition to currently unresolved factual issues, the formulation of standards involves choices that by their nature require basic policy determinations rather than resolution of factual controversies. Judicial review of inherently legislative decisions of this sort is obviously an undertaking of different dimensions.
Page 83
Institute v. OSHA, 577 F.2d 825, 833-834 (3d Cir. 1978) Ethyl Corp. v. EPA, 176 U.S.App.D.C. at 392-400, 541 F.2d at 20-28; National Asphalt Pavement Association v. Train,
176 U.S.App.D.C. 296, 304-05, 539 F.2d 775, 783-84 (1976) Society of the Plastics Industry v. OSHA, 509 F.2d 1301, 1308 (2d Cir.), cert. denied, 421 U.S. 992, 95 S.Ct. 1998, 44 L.Ed.2d 482 (1975); cf. FCC v. National Citizens Committee for Broadcasting, 436 U.S. at 814, 98 S.Ct. 2096 (broadcast licensing); Superior Oil Co. v. FERC, 563 F.2d 191, 201
(5th Cir. 1977) (information disclosure).
[70] Industry petitioners contend that EPA lacked an adequate basis for the regulations under review because of the incomplete scientific knowledge about less chlorinated PCBs. In effect, they assert that EPA must demonstrate the toxicity of each chemical it seeks to regulate through studies demonstrating a clear line of causation between a particular chemical and harm to public health or the environment. We do not agree. [71] The principal basis for rejecting petitioners’ views is the wording of the statute. As we stated, the “ample margin of safety” provision directs EPA to guard against incompletely known dangers. EPA, in its expert policy judgment, relied on its knowledge about a known substance to assess the danger of one about which less is known. Petitioners suggest no alternative approach for the agency short of waiting for conclusive proof about the danger posed by a less understood substance. However, by requiring EPA to set standards providing an “ample margin of safety,” Congress authorized and, indeed, required EPA to protect against dangers before their extent is conclusively ascertained. The statute thus does not deny EPA the authority that petitioners would have us withhold. Indeed, the legislative history indicates that Congress intended EPA to take into account “the availability of data on similar substances or compounds.”[74] Moreover, the Clean Water Act of 1977 supports the notion that extrapolation from data about related substances is a valid approach. In 1977, Congress did not list individual substances, but rather listed families of substances,[75] recognizing that similarities among substances render them susceptible to regulation by group.[76] [72] Proper deference in judicial review to the scientific expertise of the Administrator also militates against precluding EPA from regulating less chlorinated PCBs on the basis of what is known about related substances. Industrial Union Department, AFL-CIO v. Hodgson, 162 U.S.App.D.C. at 338-39, 499 F.2d at 474-75.[77] The risks posed by toxic substances, and the extent to which one substance has effects similar to those of related substances, are matters on the frontiers of scientific knowledge. EPA, not the court, has the technical expertise to
Page 84
decide what inferences may be drawn from the characteristics of related substances and to formulate policy with respect to what risks are acceptable.[78]
[73] Moreover, we are currently in a period of rapid change in assessing and regulating toxic substances. TSCA has established new regulatory mechanisms that may well lead to wholesale estimation of the risks of toxic substances.[79] A holding from this court that only one technique of risk assessment (such as “extensive studies on comparative mammalian toxicity”, Brief of Industry Petitioners at 53) is acceptable to the detriment of others would unnecessarily inhibit EPA from evaluating new approaches and formulating appropriate policy. [74] Finally, in reviewing EPA’s policy of regulating less chlorinated PCBs in part on the basis of what is known about more chlorinated PCBs, we must recognize considerations of administrative feasibility.[80] The number of toxic substances subject to regulation seems very large.[81] Regulation of so many substances could well be extremely difficult if EPA were precluded from drawing inferences from available data on well-known,Page 85
related substances. Moreover, requiring proof of causation for each chemical would force EPA to expend resources in areas that are well-enough known so that inference is acceptable, when those resources could be otherwise employed in areas where knowledge is inadequate. In ruling on the type of proof and procedure required for making individual determinations, the Supreme Court has construed statutes protecting the environment and public health in light of considerations of administrative feasibility. See E.I. du Pont de Nemours Co. v. Train, 430 U.S. at 132, 97 S.Ct. 965 (type of proof);[82] Weinberger v. Hynson, Westcott Dunning, Inc., 412 U.S. 609, 62-22, 93 S.Ct. 2469, 37 L.Ed.2d 207 (1973) (procedure).[83] See also United States v. Storer Broadcasting Co., 351 U.S. 192, 202-05, 76 S.Ct. 763, 100 L.Ed. 1081 (1956).
[75] 2. EPA’s factual determination of the particular risks here.[76] We now review the evidence presented by EPA, industry petitioners, and others. EPA did not rely on a single approach or study, but acted on the basis of a variety of studies and types of evidence. Under the substantial evidence test, it is not necessary that all the evidence, or even most of the evidence, point in one direction. The evidence supporting the agency’s conclusion must be such, in light of all of the evidence on the record as a whole, that “a reasonable mind might accept [it] as adequate to support [the] conclusion.” Consolidated Edison Co. v. NLRB, 305 U.S. at 229, 59 S.Ct. at 217. The evidence on scientific matters need not consist of one dispositive study, but may be varied and cumulative.[84] [77] We have structured our review under the “substantial evidence” test according to the primary factors of section 307(a)(2): toxicity (including carcinogenicity), persistence, and degradability as they relate to affected organisms.[85] [78] a. Toxicity
[79] The evidence presented concerning toxicity may be divided into (i) evidence bearing on aquatic organisms, (ii) evidence bearing on man, and (iii) evidence concerning the special quality of carcinogenicity.
Page 86
[80] i. Aquatic organisms[81] EPA’s Criteria Document, see App. II, and evidentiary affidavits summarized studies concerning adverse effects of all PCBs on a wide range of aquatic organisms. PCBs showed some variation in toxicity: sometimes less chlorinated PCBs were more toxic than more chlorinated PCBs, and sometimes vice-versa, with few systematic tendencies. 42 Fed.Reg. 6534, 6541.[86] [82] Petitioners contended that EPA’s evidence as to aquatic effects does not support a prohibition. They pointed out that EPA found that aquatic organisms could live with a minimal level of PCBs in the water.[87] Indeed, EPA originally proposed a low effluent standard for PCBs rather than a prohibition. New evidence concerning effects on mammals, not effects on aquatic organisms, led to the prohibition. However, this is not to say that EPA’s prohibition is unsupported by the aquatic evidence. Although mammalian evidence appears to have tipped the scales, the evidence concerning aquatic dangers lent support to a prohibition. That evidence showed that, even at low levels of discharge, PCBs might build up over time to levels that would menace aquatic organisms.[88] [83] ii. Man
[84] EPA’s Criteria Document and evidentiary affidavits summarized studies concerning adverse effects of PCBs on a wide range of mammals. EPA deemed the animal studies relevant, in part because some mammals are exposed to PCBs in their fish diet, e.g.,
domesticated mink, but mainly because mammalian data reflect risks to humans that cannot be readily determined through studies about humans. For the reasons previously discussed, the Criteria Document summarized many studies on more chlorinated PCBs,[89]
but almost none on less chlorinated PCBs. See note 66 supra
accompanying text. After the preparation of the Criteria Document, during the hearings EPA brought forth a few recent studies about the effects of less chlorinated PCBs. These studies lacked the wealth of detail of the studies on more chlorinated PCBs, but did show ill effects.[90] [85] In addition to animal studies, EPA summarized some studies on humans, relating to occupational diseases[91] and poisoning incidents.[92]
Page 87
These studies dealt only with effects of more chlorinated PCBs.
[86] In opposition, industry petitioners criticized EPA’s studies of less chlorinated PCBs.[93] They sought to minimize evidence of the effects of more chlorinated PCBs by asserting that less chlorinated PCBs were different.[94] [87] We hold that EPA’s toxicity evidence provided support for the prohibition. It is well established that evidence concerning toxic effects on mammals is probative of dangers to man. “Although extrapolation of data from mice to men may be quantitatively imprecise, it is sufficient to establish a `substantial likelihood’ that harm will result.” EDF v. EPA[aldrin and dieldrin], 167 U.S.App.D.C. 71, 78, 510 F.2d 1292, 1299 (1975). Similarly, evidence concerning occupational diseases and incidents of poisoning appears to be very probative of dangers to man.[95] [88] As we have held, EPA did not err in using data generated in studies of more chlorinated PCBs in dealing with less chlorinated PCBs. Industry petitioners’ criticisms of EPA’s studies of less chlorinated PCBs, while relevant, do not preclude EPA from considering the studies to be support for a prohibition. [89] iii. Carcinogenicity
[90] In the EPA proceedings, as in the public debate over PCBs,[96] an issue of considerable importance was whether PCBs cause cancer. EPA introduced studies showing that exposure to more chlorinated PCBs produces cancer and cancer-like growths in rats. App. II 251-53 Appendix D. EPA also introduced studies showing that more chlorinated PCBs are mutagenic, App. II 254, which, according to commentators, suggests that they may be carcinogenic.[97] Finally, EPA introduced studies that PCBs, including less chlorinated PCBs, are enzyme inducers,[98]
indicating that they may be cocarcinogenic — that is, that they may produce cancer when they act in combination with other substances.[99] EDF introduced evidence showing that on-the-job exposure to more chlorinated PCBs decades ago resulted eventually in a high incidence of cancer. App. I 168.
Page 88
[91] Industry petitioners respond that the evidence that less chlorinated PCBs are carcinogenic is far from conclusive. Again, they earnestly contend that evidence concerning more chlorinated PCBs fails to support regulation of less chlorinated PCBs. In response to the studies showing that less chlorinated PCBs are enzyme inducers, they introduced expert testimony disputing that enzyme inducers are necessarily carcinogenic or co-carcinogenic. “The role of enzyme induction, especially in chemical carcinogenesis, is not as yet very well understood. . . . [I]t must remain highly speculative to deduce enhancement of chemical carcinogenesis by enzyme induction by PCBs.” App. I 234 (testimony of Dr. Mueller). [92] After review of the authorities on the difficult issue of carcinogenic effect, we conclude that EPA’s evidence furnishes adequate support for its prohibition. An administrator has a “heavy burden” to “explain the basis for his decision to permit the continued use of a chemical known to produce cancer in experimental animals.” EDF v. Ruckelshaus [DDT], 142 U.S.App.D.C. 74, 86, 439 F.2d 584, 596 n. 41 (1971); accord, EDF v. EPA[heptachlor and chlordane], 179 U.S.App.D.C. 43, 50, 548 F.2d 998, 1005 (1976), cert. denied, 431 U.S. 925, 97 S.Ct. 2199, 53 L.Ed.2d 239 (1977); EDF v. EPA [aldrin and dieldrin], 167 U.S.App.D.C. at 74, 510 F.2d at 1302; see EDF v. Department of Health, Education and Welfare, 138 U.S.App.D.C. at 388-90, 428 F.2d at 1090-92. When firm evidence establishes that a chemical is a carcinogen, statutes generally leave an administrator no alternative but to step in to protect the public. [93] On the other hand, when the evidence is less than firm, but merely suggests that a chemical may be a carcinogen, the same “heavy burden” may not attend administrative inaction. The decision to act in such a case has been held to fall within the discretion of the Administrator. For example, in Reserve Mining Co. v. EPA, 514 F.2d 492 (8th Cir. 1975) (en banc), EPA sought to abate discharge of mining refuse into Lake Superior “under an acceptable but unproved medical theory,” that the discharges were carcinogenic. 514 F.2d at 529. The court concluded that the discharges should be abated, even though there would be a heavy cost, including possible loss of many jobs, to the local economy Id. at 514-20, 535-40. Similarly, in Certified Color Manufacturers Association v. Mathews, 177 U.S.App.D.C. 137, 150, 543 F.2d 284 (1976), the Food and Drug Administration (FDA) terminated its provisional approval of a color additive used to dye food on the basis of a vigorously debated study of the additive’s carcinogenic effects. This court concluded that the FDA action should be upheld, based upon FDA’s scientific judgment that the study was not conclusive, but was merely suggestive of carcinogenicity. Id. 177 U.S.App.D.C. at 150, 543 F.2d at 297. “Courts have traditionally recognized a special judicial interest in protecting the public health, particularly where `the matter involved is as sensitive and fright-laden as cancer.’ Where the harm envisaged is cancer, courts have recognized the need for action based upon lower standards of proof than otherwise applicable.” Id. 177 U.S.App.D.C. at 150, 543 F.2d at 297-98
(footnotes omitted) (quoting EDF v. EPA [DDT], 150 U.S.App.D.C. 348, 358, 465 F.2d 528, 538 (1972)). The courts have frequently upheld regulations based on evidence of carcinogenic effects See, e.g., American Iron Steel Institute v. OSHA, 577 F.2d at 840, 841 (coke oven emissions); Society of the Plastics Industry v. OSHA, 509 F.2d at 1311 (vinyl chloride); Synthetic Organic Chemical Manufacturers Association v. Brennan, 506 F.2d 385, 387 (3d Cir. 1974) (industrial chemicals), cert. denied, 423 U.S. 830, 96 S.Ct. 50, 46 L.Ed.2d 48 (1975); Synthetic Organic Chemical Manufacturers Association v. Brennan, 503 F.2d 1155, 1159-60 (3d Cir.) (same), cert. denied, 420 U.S. 973, 95 S.Ct. 1396, 43 L.Ed.2d 653 (1974). [94] These cases demonstrate the inevitable tension attending regulation of carcinogens. Frequently, such regulations have severe economic impact. Indeed, sometimes, as alleged by industry petitioners in this case, such regulations may jeopardize plants or whole industries, and the jobs depending on
Page 89
them. In such circumstances, the temptation to demand that the agency furnish conclusive proof of carcinogenicity as support for the regulations is great. However, the decision to delegate authority to an agency to control suspected carcinogens is a legislative judgment that is not open to question in this court. Congress’s direction to EPA to protect against incompletely understood dangers could not be carried out if we were to adopt the proof requirements advocated by industry petitioners.
[95] What scientists know about the causes of cancer is how limited is their knowledge.[100] The record in this case demonstrates that it may take decades for human exposure to carcinogens to result in cancer;[101] in the meantime, the case for inferring a cancer danger with respect to an incompletely understood substance is vigorously disputed. If regulation were withheld until the danger was demonstrated conclusively, untold injury to public health could result. Accordingly, we find that Congress has allowed EPA to support a prohibition on the basis of strongly contested and merely suggestive proof. We conclude that the evidence in this case is at least suggestive of carcinogenicity and thus supports EPA’s decision. [96] b. Persistence[97] EPA summarized studies showing that PCBs tend to accumulate in the environment over many years, are mobile, and adhere to sediments.[102] This court has noted before that such characteristics intensify the dangers posed by toxic substances, because they increase the exposure of persons and vulnerable organisms of all kinds to those substances. See EDF v. EPA
[heptachlor and chlordane], 179 U.S.App.D.C. at 53, 548 F.2d at 1008; EDF v. EPA [aldrin and dieldrin], 167 U.S.App.D.C. at 73, 510 F.2d at 1301.[103] Accordingly, these studies provide support for EPA’s prohibition. [98] c. Degradability
[99] EPA summarized a number of studies concerning the degradation of both less and more chlorinated PCBs by living organisms. PCBs were shown to resist degradation, to bioaccumulate (build up) to high levels in simple organisms, and then to bioaccumulate further as those simple organisms are
Page 90
consumed by higher organisms.[104] 42 Fed.Reg. 6539-41. When degradation does occur, it may result in creation of other harmful substances, either as intermediates, or as end products of degradation.[105] Industry petitioners disputed EPA’s evidence, and produced their own evidence that less chlorinated PCBs are more easily metabolized and eliminated, and less likely to bioaccumulate than more chlorinated PCBs. They also contended that these substances degrade by safe routes into non-dangerous substances. App. I 209-12, 237-39.
[100] However, the conclusions advanced by industry petitioners do not necessarily weaken the support for EPA’s prohibition. It was not necessary for EPA to prove that less chlorinated PCBs were as dangerous as more chlorinated PCBs in order to justify a prohibition. The central issue is not whether less chlorinated PCBs are less degradable than more chlorinated PCBs, but whether less chlorinated PCBs are insufficiently degradable. Our task in reviewing the record is not to choose between these conflicting studies, but rather to determine whether EPA’s decision had substantial evidence on the whole record. Viewed as a whole, the record provided substantial support for EPA’s conclusions. [101] 3. Conclusion.[102] Under the substantial evidence standard of review, EPA is not required to “prove” its case in the reviewing court “in some sense of weight of the evidence.” EDF v. EPA [heptachlor and chlordane], 179 U.S.App.D.C. at 50, 548 F.2d at 1005. Its policy decisions are subject to deferential review, and its factual conclusions are upheld although they may not be supported by all the evidence, or even by most of it. It suffices that EPA’s conclusions are supported by “such relevant evidence as a reasonable mind might accept as adequate to support [the] conclusion[s].” Consolidated Edison Co. v. NLRB, 305 U.S. at 229, 59 S.Ct. at 217. On this record, it is clear that EPA’s prohibition on discharges of PCBs must be upheld.
[103] VI. PETITIONS BY EDF AND BASS.[104] A. Petition by EDF.
[105] EDF petitioned for review of EPA’s failure to perform its duty to cover an alleged “loophole” in the PCBs prohibition: EPA’s regulations apply only to current manufacturers and users of PCBs. EDF contends that past manufacturers and users who have ceased making or using PCBs continue the use of sewer pipes and other equipment contaminated with PCBs, and that the resulting discharges will continue to introduce PCBs into the nation’s waters. Because EPA’s findings show that continuing PCBs pollution is dangerous, EDF contends that EPA should promulgate additional regulations concerning past manufacturers and users. EDF does not specify whether EPA’s alleged duty to close this “loophole” is mandatory or discretionary, but presumably urges that EPA’s failure to act may be countermanded either as a failure to perform a mandatory duty or as an abuse of discretion.
Page 91
with the issues that concern EDF. In essence, EDF contends that EPA should have engaged in an additional rulemaking proceeding. Jurisdiction over EDF’s claim lies only in the district court See Currie, Judicial Review under Federal Pollution Laws,
62 Iowa L.Rev. 1221, 1250 (1977) (“When there has been no proceeding, there is no administrative record, and, consequently, greater likelihood of need for a trial; therefore, the district court is the appropriate forum.”).
[109] The Bass Anglers Sportsman Society of America (BASS) petitioned for review of EPA’s regulations on several grounds: that EPA’s choice of an “acceptable analytical method” for measuring PCBs discharges was inadequate, and that EPA’s failure to promulgate other toxic or pretreatment regulations was arbitrary and capricious. Because BASS did not participate in EPA’s PCBs proceedings, its petition must be dismissed. See Nader v. NRC,
168 U.S.App.D.C. 255, 264-65, 513 F.2d 1045, 1054-55 (1975).
[110] VII. CONCLUSION
[111] For the foregoing reasons, we uphold EPA’s regulations prohibiting discharges of PCBs, and dismiss the petitions of EDF and BASS.
(1) The Administrator shall, within ninety days after October 18, 1972, publish (and from time to time thereafter revise) a list which includes any toxic pollutant or combination of such pollutants for which an effluent standard (which may include a prohibition of the discharge of such pollutants or combination of such pollutants) will be established under this section. The Administrator in publishing such list shall take into account the toxicity of the pollutant, its persistence, degradability, the usual or potential presence of the affected organisms in any waters, the importance of the affected organisms and the nature and extent of the effect of the toxic pollutant on such organisms.
(2) Within one hundred and eighty days after the date of publication of any list, or revision thereof, containing toxic pollutants or combination of pollutants under paragraph (1) of this subsection, the Administrator, in accordance with section 553 of Title 5, United States Code shall publish a proposed effluent standard (or a prohibition) for such pollutant or combination of pollutants which shall take into account the toxicity of the pollutant, its persistence, degradability, the use or potential presence of the affected organisms in any waters, the importance of the affected organisms and the nature and extent of the effect of the toxic pollutant on such organisms, and he shall publish a notice for a public hearing on such proposed standard to be held within thirty days. As soon as possible after such hearing, but not later than six months after publication of the proposed effluent standard (or prohibition), unless the Administrator finds, on the record, that a modification of such proposed standard (or prohibition) is justified based upon a preponderance of evidence adduced at such hearings, such standard (or prohibition) shall be promulgated.
(3) If after a public hearing the Administrator finds that a modification of such proposed standard (or prohibition) is justified, a revised effluent standard (or prohibition) for such pollutant or combination of pollutants shall be promulgated immediately. Such standard (or prohibition) shall be reviewed and, if appropriate, revised at least every three years.
(4) Any effluent standard promulgated under this section shall be at that level which the Administrator determines provides an ample margin of safety.
(5) When proposing or promulgating any effluent standard (or prohibition) under this section, the Administrator shall designate the category or categories of sources to which the effluent standard (or prohibition) shall apply. Any disposal of dredged material may be included in such a category of sources after consultation with the Secretary of the Army.
(6) Any effluent standard (or prohibition) established pursuant to this section shall take effect on such date or dates as specified in the order promulgating such standard, but in no case more than one year from the date of such promulgation.
(7) Prior to publishing any regulations pursuant to this section the Administrator shall, to the maximum extent practicable within the time provided, consult with appropriate advisory committees, States, independent experts, and Federal departments and agencies.
In this respect, the PCBs problem played a part in generating public support for strengthened regulation of toxic substances in the 1970’s similar to the part that problems with adulterated food played in generating public support for food and drug regulation at the turn of the century, and that problems with hazardous drugs played in generating public support for strengthened drug regulation in the 1930’s and 1960’s. See generally Food and Drug Act of 1906, c. 3915, 34 Stat. 768; Federal Food, Drug, and Cosmetic Act of 1938, ch. 675, 52 Stat. 1040; Drug Amendments of 1962, Pub.L. No. 87-871, 76 Stat. 780; U. Sinclair, The Jungle (1906); Note, Drug Efficacy and the 1962 Drug Amendments, 60 Geo.L.J. 185, 186 n. 13, 191 n. 45 (1971) (describing the impact on drug laws of the sulfanilamide disaster in the 1930’s and the thalidomide disaster in the 1960’s).
at ___-___ of 194 U.S.App.D.C., at 70 of 598 F.2d.
194 U.S.App.D.C. at ___-___, 598 F.2d at 113, 114.
In congressional testimony, an EPA official focused more precisely on the basic data problem — Congress had overestimated the available data on toxic substances:
In requiring EPA to publish within 90 days of passage of the Act a list of toxic pollutants to be regulated under this section, Congress apparently assumed the existence of a substantial body of data on the toxicity and persistence of pollutants, the identity of the dischargers thereof, and the feasibility of effective control. In fact, little of this type of information existed for more than a few toxic pollutants, given the overall size of the field. Moreover, the task of assembling and evaluating these data, and filling gaps when they were discovered, proved to be far more than a 90 day exercise.
Implementation of the Federal Water Pollution Control Act (Regulation and Monitoring of Toxic and Hazardous Chemicals): Hearings Before the Subcomm. on Investigations and Review of the House Comm. on Public Works and Transportation (hereafter Toxic Chemical Hearings), 95th Cong., 1st Sess. 406 (1977) (statement of Thomas Jorling, EPA Asst. Administrator for Water and Hazardous Substances) (emphasis added).
The principal regulatory mechanism for the control of toxics in Public Law 92 500 as originally enacted was contained in section 307(a), which set forth the requirement for toxic effluent standards to be issued for toxic pollutants identified by the Administrator. Frankly, it has failed.
Procedural requirements have proven insurmountable for the Agency, to the point where only six toxic chemicals — aldrin/dieldrin, endrin, DDT, toxaphene, benzidine and PCBs — have been regulated. Six chemicals in 5 years.
The Agency’s problems have included uncertainty with respect to the intended breadth of the regulatory effort, lack of toxicological and biological data for many chemicals, and scientific disputes over what amount of a “toxic” pollutant . . . can be considered as “safe.” But far and away the most severe single problem has been the formal, cumbersome rulemaking process.
123 Cong.Rec. H12927 (daily ed. Dec. 15, 1977).
During these hearings, industry objectors introduced evidence which raised problems in the following areas: analytical and monitoring technology, hydrological assumptions contained in the proposed standards (which varied depending on the character and flow rate of the receiving waters), availability of control technology, impact of proposed standards on important segments of the nation’s economy, and identity of point source discharges.
As discussed in this opinion and in Hercules, Inc. v. EPA,
194 U.S.App.D.C. at ___-___, 598 F.2d at 111, decided today, many of these concerns are irrelevant to section 307(a) standards.
183 U.S.App.D.C. 11, 561 F.2d 904 (1977).
177 U.S.App.D.C. 181, 543 F.2d 328, cert. dismissed, 429 U.S. 967, 97 S.Ct. 398, 50 L.Ed.2d 335 (1976); American Frozen Food Inst. v. Train, 176 U.S.App.D.C. 105, 539 F.2d 107 (1976).
The legislative history further elaborates:
The following substances were mentioned in relation to potential toxic effects by the President’s Council of Environmental Quality (April, 1971) in a report entitled Toxic Substances: lead, cadmium, mercury, vanacium, arsenic, molybdenum, antimony, nickel, barium, beryllium, copper, selenium, zinc, nitrilotriacetic acid (NTA), orthonitrochlorobenzene (ONCB), polychlorinated biphenyls (PCB’s), dichlordiphenyltrichloroethane (DDT). The Committee expects the Administrator to give first consideration to these pollutants in the exercise of his authority under Section 307.
Id. at 1495-96 (Senate Report) (discussion of definition of toxic pollutants).
Environmental diseases related to the use of various toxic substances have been increasing, “particularly during the past ten years,” Dr. Hargraves believes. From extensive clinical experience he believes that “the vast majority of patients suffering from the blood dyscrasias and lymphoid diseases have a significant history of exposure to the various hydrocarbons which in turn includes most of the pesticides of today. A careful medical history will almost invariably establish such a relationship.” This specialist now has a large number of detailed case histories based on every patient he has seen with leukemias, aplastic anemias, Hodgkin’s disease, and other disorders of the blood and bloodforming tissues. “They had all been exposed to these environmental agents, with a fair amount of exposure,” he reports.
Id. at 227. A number of the points in the book formed the basis for legislation and regulation. For example, the book noted the increasing concern about contamination of public water supplies by carcinogens and co-carcinogens. See id. at 238-39. In 1974, “Congress passed the Safe Drinking Water Act in response to increasing indications of a serious threat to health from contaminants in our drinking water not related to communicable disease. . . . There is ample evidence establishing the fact that our drinking water is contaminated with a large variety of organic substances, of demonstrated carcinogenicity in animals.”EDF v. Costle [Safe Drinking Water], 188 U.S.App.D.C. 95 at 101, 103, 578 F.2d 337 at 343, 345 (1978).
Throughout the 94th Congress, accounts of chemical dangers were drawn from newspapers around the nation and introduced into the Congressional Record in support of the Act. As much as any direct lobbying activity, such reports argued persuasively in favor of stringent regulation and gave credence to the contentions of consumer and environmental advocates. See 122 Cong.Rec. H1206-08 (daily ed. Feb. 19, 1976), E1449-50 (daily ed. Mar. 22, 1976), S4005-07, E1487 89 (daily ed. Mar. 23, 1976), S4142 (daily ed. Mar. 24, 1976), S4239-40, E1544-45, E1554-56 (daily ed. Mar. 25, 1976), E1649-51, E1676-78 (daily ed. Mar. 30, 1976), E1710-11, E1714-16 (daily ed. Mar. 31, 1976), E1725-26 (daily ed. Apr. 1, 1976), E1847-48 (daily ed. Apr. 6, 1976), E1879 (daily ed. Apr. 7, 1976), E1942 (daily ed. Apr. 9, 1976), E2016-18 (daily ed. Apr. 13, 1976), S10145-46 (daily ed. June 22, 1976), S13666-67 (daily ed. Aug. 5, 1976).
The term “toxic pollutant” means those pollutants, or combinations of pollutants, including disease-causing agents, which after discharge and upon exposure, ingestion, inhalation or assimilation into any organism, either directly from the environment or indirectly by ingestion through food chains, will, on the basis of information available to the Administrator, cause death, disease, behavorial abnormalities, cancer, genetic mutations, physiological malfunctions (including malfunctions in reproduction) or physical deformations, in such organisms or their offspring.
The legislative history discusses the function of the definitional section:
A definition of toxic substance is provided to assist the Administrator in implementing his authority under section 307 to regulate toxic discharges. The definition provides a benchmark for evaluating those pollutants which in certain concentrations would have a particularly adverse impact on humans as well as other forms of life.
Legislative History at 1495 (Senate Report).
194 U.S.App.D.C. at ___, 598 F.2d at 117.
The employee who presides at the reception of evidence pursuant to section 556 of this title shall make the recommended decision or initial decision required by section 557 of this title, unless he becomes unavailable to the agency. Except to the extent required for the disposition of ex parte matters as authorized by law, such an employee may not —
(1) consult a person or party on a fact in issue, unless on notice and opportunity for all parties to participate; or
(2) be responsible to or subject to the supervision or direction of an employee or agent engaged in the performance of investigative or prosecuting functions for an agency.
An employee or agent engaged in the performance of investigative or prosecuting functions for an agency in a case may not, in that or a factually related case, participate or advise in the decision, recommended decision, or agency review pursuant to section 557 of this title, except as witness or counsel in public proceedings. This subsection does not apply —
(A) in determining applications for initial licenses;
(B) to proceedings involving the validity or application of rates, facilities, or practices of public utilities or carriers; or
(C) to the agency or a member or members of the body comprising the agency.
EPA contends that even if section 5(d) of the Administrative Procedure Act, 5 U.S.C. § 554(d) (1976), applied to this rulemaking proceeding, it would not prevent Mr. Settle’s participation as a special or acting judicial officer, because Mr. Settle played no role in the instant proceedings and was employed by a branch of the General Counsel’s office that had no responsibilities for any investigative or prosecuting functions in the proceedings. Because of our disposition of the case, we have no occasion to reach this issue.
181 U.S.App.D.C. 99, 106, 555 F.2d 1036, 1043 (1977).
While it is clear that the Administrator’s determination that it is in the public interest to use this Act, is a completely discretionary decision not subject to judicial review in any manner, it is expected that the Administrator will review the other authorities and present the results of that review at the same time the Administrator takes action under this Act. While the Administrator’s decision to use this Act, notwithstanding the other authorities, is unreviewable by any court, a reviewing court is expected to require that the Administrator have examined the other authorities and present the results of that examination when making the finding that it is in the public interest to use this Act . ..
This provision is not to be construed to relieve the Administrator of any requirement imposed by other Federal laws upon the Administrator, and of course nothing in this Act shall affect any final action taken under other Federal laws administered by the Administrator or in any way affect the extent to which health or the environment is to be protected under such other Federal laws.
Relatively few chemicals have had to be regulated because of environmental or health hazards. A very significant proportion of those regulated chemicals are organochlorine compounds, including DDT, aldrin-dieldrin, heptachlor-chlordane, hexachlorophene, and vinyl chloride. Other organochlorines, including nearly all pesticides of this class, are currently under scrutiny. Among these are PCB’s, mirex, tricholoethylene, hexachlorobenzene, carbon tetrachloride, and chloroform, to name a few. Chlorination of drinking water supplies and industrial effluents has come under question because the process apparently forms cancer-causing organochlorines.
Thus, it appears that organochlorine compounds as a class are becoming suspect of causing a significant share of ecological and health problems resulting from chemicals in the environment.
For the court to state as a matter of law at what point on this spectrum of chemical similarity inference may begin, and at what point it must end, would be inconsistent with our limited judicial function. Indus. Union Dep’t. AFL-CIO v. Hodgson,
162 U.S.App.D.C. 331, 336-40, 499 F.2d 467, 472-76 (1974).
123 Cong.Rec. H12929, 12931 (daily ed. Dec. 15, 1977).
(1977) (quoting Permian Basin Area Rate Cases, 390 U.S. 747, 777, 88 S.Ct. 1344, 1365, 20 L.Ed.2d 312 (1968)): “`”[C]onsiderations of feasibility and practicality are certainly germane” to the issues before us. Bowles v. Willingham [321 U.S. 503, 64 S.Ct. 641, 88 L.Ed. 892,] 517, 64 S.Ct. 641. We cannot, in these circumstances, conclude that Congress has given authority inadequate to achieve with reasonable effectiveness the purposes for which it has acted.'”
The NAS-NRC panels evaluated approximately 16,500 claims made on behalf of the 4,000 drugs marketed pursuant to effective NDA’s in 1962. Seventy percent of these claims were found not to be supported by substantial evidence of effectiveness, and only 434 drugs were found effective for all their claimed uses. If FDA were required automatically to hold a hearing for each product whose efficacy was questioned by the NAS-NRC study, even though many hearings would be an exercise in futility, we have no doubt that it could not fulfill its statutory mandate to remove from the market all those drugs which do not meet the effectiveness requirements of the Act.
176 U.S.App.D.C. 373, 409-10, 541 F.2d 1, 37-38 (en banc), cert. denied, 426 U.S. 941, 96 S.Ct. 2663, 49 L.Ed.2d 394 (1976) (footnote omitted), EPA regulated lead additives in gasoline based on a number of suggestive studies, rather than one dispositive study. This court upheld EPA’s approach:
Contrary to the apparent suggestion of some of the petitioners, we need not seek a single dispositive study that fully supports the Administrator’s determination. Science does not work that way; nor, for that matter, does adjudicatory fact-finding. Rather, the Administrator’s decision may be fully supportable if it is based, as it is, on the inconclusive but suggestive results of numerous studies. By its nature, scientific evidence is cumulative: the more supporting, albeit inconclusive, evidence available, the more likely the accuracy of the conclusion.
Discovering links between chemicals and health problems is a slow process, usually succeeding only after a relatively long history of use or exposure. In the meantime, however, chemical development proceeds at a rapid pace. About 2 million chemical compounds are known, and each year thousands more are discovered by the U.S. chemical industry and hundreds are introduced commercially. We know very little about the possible health consequences of these new compounds. Many are not toxic, but the sheer number of chemical compounds, the diversity of their use, and the adverse effects already encountered from some make it increasingly probable that chemical contaminants in our environment have become a significant determinant of human health and life expectancy.
. . . . .
Most of the details of how and why cancers develop still elude scientists and physicians, so that the exact causative factors of observed malignancies cannot be defined.