Rehearing Denied in No. 77-1462 December 14, 1978.
Opinion for the court filed by TAMM, Circuit Judge.
TABLE OF CONTENTS Page I. FACTS AND PRIOR PROCEEDINGS. -------------------------------- 65 A. Factual Background on PCBs. ------------------------------ 65 B. PCBs Proceedings. ---------------------------------------- 68 II. STATUTORY FRAMEWORK. ---------------------------------------- 71 III. PROCEDURAL CHALLENGES. -------------------------------------- 74 IV. INTERACTION WITH TOXIC SUBSTANCES CONTROL ACT. -------------------------------------------------------- 76 V. EVIDENTIARY BASIS FOR REGULATION OF LESS CHLORINATED PCBs. ------------------------------------------- 78 A. Arguments of the Parties. ------------------------------- 78 B. Applicable Legal Standards. ----------------------------- 79 C. Scope of Review. ---------------------------------------- 82 D. Adequacy of the Basis for EPA Regulations. -------------- 83 1. EPA's policy judgments concerning extrapolation. ---- 83 2. EPA's factual determination of the particular risks here. ----------------------------------------------- 85 a. Toxicity ---------------------------------------- 85 i. Aquatic organisms ------------------------- 86 ii. Man --------------------------------------- 86 iii. Carcinogenicity --------------------------- 87 b. Persistence ------------------------------------- 89 c. Degradability ----------------------------------- 89 3. Conclusion. ----------------------------------------- 90 VI. PETITIONS BY EDF AND BASS. ---------------------------------- 90 A. Petition by EDF. ---------------------------------------- 90 B. Petition by Bass. --------------------------------------- 91 VII. CONCLUSION. ------------------------------------------------- 91
TAMM, Circuit Judge:
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.
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).
I. FACTS AND PRIOR PROCEEDINGS.
A. Factual Background on PCBs.
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
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.
In 1971-72, in response to public and government pressure, PCBs manufacturers and users took initial steps to reduce the PCBs danger.
However, in 1972-74 manufacturers were curtailing their efforts to find acceptable substitutes for PCBs,
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.
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.
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.
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,
B. PCBs Proceedings.
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.
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),
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).
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.
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.
Following the failure in 1974 of its initial regulatory efforts, and consistent with the regulatory program and consent decree eventually adopted, EPA set out in 1975 to investigate PCBs more thoroughly. It commissioned a survey of the scientific literature on PCBs, and sponsored a national conference on PCBs in November 1975.
Based on these preparations, EPA proposed effluent standards for PCBs discharges on July 14, 1976. The proposed standards allowed on the average no more than one part per billion of PCBs in certain discharges by manufacturers of electrical equipment, and prohibited any PCBs in other discharges by manufacturers of electrical equipment and in all discharges by manufacturers of PCBs. The proposed regulations made no distinction between more chlorinated PCBs and less chlorinated PCBs. See 41 Fed.Reg. 30476-77 (1976).
On August 20, EPA commenced a formal rulemaking hearing before an administrative law judge on the proposed PCBs standards, which was concluded on November 30 after twenty-one days of testimony. In addition to the Criteria Document, EPA presented testimony of twenty-two witnesses. See 42 Fed.Reg. 6532. The PCB Ad Hoc Committee of the Electronics Industry Association, consisting of nine manufacturers of capacitors, proposed more relaxed standards of 100 parts per billion for discharges of one type of less chlorinated PCBs, Aroclor 1016, and Westinghouse Electric Corp. proposed a standard of 50 parts per billion for discharges of another, Aroclor 1242. These parties (hereafter, industry petitioners) presented the testimony of seven witnesses. See id. at 6532, 6541. The Environmental Defense Fund (EDF) presented the testimony of one witness concerning carcinogenic effects of PCBs. Three other parties participated in the hearing, and thirteen persons or entities filed written comments. At the close of the hearing, the record was furnished to the EPA Administrator (Administrator) for his consideration.
In January 1977, the Administrator filed his final decision
II. STATUTORY FRAMEWORK.
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.
The Supreme Court and this court have previously reviewed industrial source effluent regulations.
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.
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
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.
More complex than the section's substantive provisions are its procedural provisions,
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,
III. PROCEDURAL CHALLENGES.
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,
Second, petitioners contend that EPA's assignment of a staff attorney to act as a special judicial officer in this proceeding was improper. Industry petitioners' challenge to this assignment is the only procedural contention in this case not paralleled
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."
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.
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.
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."
IV. INTERACTION WITH TOXIC SUBSTANCES CONTROL ACT.
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.
Industry petitioners contend that this section of TSCA was intended to "preempt" EPA's authority under the 1972 Act. They assert that EPA's ban on discharges of PCBs into waterways makes manufacture and processing of PCBs impossible and that TSCA's phase-out timetable and exemption authority show that Congress did not intend PCBs to be completely and immediately phased out. Therefore, the argument goes, EPA should not achieve this result by the use of its authority under another regulatory provision, the toxics section of the 1972 Act. EPA responds that Congress did not intend section 6(e) to deprive it of its authority under the 1972 Act.
We agree with EPA. Strictly speaking, the claim made by industry petitioners is one of "repeal by implication," the overriding of one statute by a later enactment sub silentio, 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
Not only is there no "clearly expressed congressional intention" that TSCA repeal EPA's prior regulatory authority, and no "irreconcilable conflict" between TSCA and the 1972 Act, but, in fact, Congress carefully and explicitly harmonized TSCA with prior enactments. Section 9(b) of TSCA, 15 U.S.C. § 2608(b) (1976) (emphasis added), provides, in part:
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.
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.
V. EVIDENTIARY BASIS FOR REGULATION OF LESS CHLORINATED PCBs.
A. Arguments of the Parties.
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.
PCBs are a group of related chemicals that have two aspects in common. First, they share a basic chemical structure known as the "biphenyl" structure, consisting of two rings of carbon atoms with hydrogen atoms attached.
Commercially, PCBs are manufactured and sold in the form of mixtures. Some mixtures contain predominantly PCBs with few chlorine atoms per molecule; these are termed "less chlorinated PCBs."
As we have discussed, more chlorinated PCBs were the main PCBs in use from 1929
Accordingly, EPA faced a familiar choice in this proceeding. On one hand, it could regulate a substance whose properties were incompletely understood (less chlorinated PCBs) by relying, in major part, upon its knowledge about more familiar substances (more chlorinated PCBs), despite the uncertainties of extrapolation from one substance to another. On the other hand, it could delay regulation until science could more fully explore the risks of the new substance.
Industry petitioners contend that EPA lacked an adequate basis for regulation because of this incompleteness in the scientific knowledge about less chlorinated PCBs mixtures. They argue that EPA "could not have reasonably hoped to regulate Aroclors 1016 and 1242 [less chlorinated PCBs] without commissioning extensive studies on comparative mammalian toxicity. The Agency failed to commission such studies. . . . It is the failure of the Administrator to present studies relating to Aroclors 1016 and 1242 which has led to his attempt to build an elaborate evidentiary house of cards." Brief for Industry Petitioners at 53. Petitioners assert, in effect, that EPA cannot rely upon merely suggestive evidence or upon extrapolation from data concerning related substances to justify regulation of the less chlorinated PCBs. They insist that EPA must trace a line of direct causation from each substance it regulates to the danger requiring regulation.
In response, EPA disputes that it must produce such direct proof concerning the danger posed by every regulated substance. EPA notes that the statutory standard calls for setting discharge levels at the level that will provide "an ample margin of safety," and cites prior authority, particularly Ethyl Corp. v. EPA, 176 U.S.App.D.C. 373, 541 F.2d 1 (en banc), cert. denied, 426 U.S. 941, 96 S.Ct. 2663, 49 L.Ed.2d 394 (1976), to support its position. In EPA's view, action need not be delayed while a risky situation persists — that is, until the extent of the danger is fully ascertained. EPA contends that ample evidence showing the danger of more chlorinated PCBs together with scientific reasoning and evidence that less chlorinated PCBs share some dangerous qualities of more chlorinated PCBs, constitutes an adequate basis for regulation.
B. Applicable Legal Standards.
Section 307(a)(2) sets forth the relevant factors for setting toxic effluent standards.
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.
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,
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.
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.
The "ample margin of safety" standard was taken originally from technical jargon
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."
C. Scope of Review.
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." In 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."
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:
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 & Steel
D. Adequacy of the Basis for EPA Regulations.
1. EPA's policy judgments concerning extrapolation.
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.
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."
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.
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.
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.
2. EPA's factual determination of the particular risks here.
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.
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.
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.
i. Aquatic organisms
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.
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.
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,
In addition to animal studies, EPA summarized some studies on humans, relating to occupational diseases
In opposition, industry petitioners criticized EPA's studies of less chlorinated PCBs.
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.
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.
In the EPA proceedings, as in the public debate over PCBs,
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.
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).
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
What scientists know about the causes of cancer is how limited is their knowledge.
EPA summarized studies showing that PCBs tend to accumulate in the environment over many years, are mobile, and adhere to sediments.
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
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.
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.
VI. PETITIONS BY EDF AND BASS.
A. Petition by EDF.
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.
We do not reach EDF's arguments on the merits, for we conclude that these arguments may only be presented to a district court.
Jurisdiction lies in a district court whether EPA's alleged duty is mandatory or discretionary. If the duty is mandatory, section 505 of the 1972 Act, 33 U.S.C. § 1365 (1976), expressly confers jurisdiction on the district court. See Ethyl Corp. v. EPA, 176 U.S.App.D.C. at 386 n. 21, 541 F.2d at 14 n. 21 (Clean Air Act). See generally NRDC v. Train, 545 F.2d 320 (2d Cir. 1976) (Clean Air Act). If the duty is discretionary, jurisdiction over the claim that EPA abused its discretion lies in district court. NRDC v. Train, 171 U.S.App.D.C. at 155, 519 F.2d at 291.
B. Petition by BASS.
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).
For the foregoing reasons, we uphold EPA's regulations prohibiting discharges of PCBs, and dismiss the petitions of EDF and BASS.
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).
In congressional testimony, an EPA official focused more precisely on the basic data problem — Congress had overestimated the available data on toxic substances:
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).
123 Cong.Rec. H12927 (daily ed. Dec. 15, 1977).
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.
The legislative history further elaborates:
Id. at 1495-96 (Senate Report) (discussion of definition of toxic pollutants).
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).
The legislative history discusses the function of the definitional section:
Legislative History at 1495 (Senate Report).
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.
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).