Document gavaGD2JRQX4KGpv3Kvx05b3a

(Scheduled for Oral Argum nt En Banc April 29, 1987) UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT No. 85-1150 NATURAL RESOURCES DEFENSE COUNCIL, INC., Petitioner, v. ENVIRONMENTAL PROTECTION AGENCY, et al., Respondents. On Petition for Review of an Action of the Environmental Protection Agency SUPPLEMENTAL BRIEF ON REHEARING FOR THE AMERICAN PETROLEUM INSTITUTE AS AMICUS CURIAE Of Counsel: G. William Frick Martha A. Beauchamp AMERICAN PETROLEUM INSTITUTE 1220 L Street, N.W. Suite 900 Washington, D.C. 20005 (202) 682-8248 April 13, 1987 Arthur F. Sampson, III John Gibson Mullan KIRKLAND & ELLIS 655 Fifteenth Street, N. Suite 1200 Washington, D.C. 20005 (202) 879-5066 Counsel for the American Petroleum Institute CTL028435 (Scheduled for Oral Argument En Banc April 29, 1987) UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT No. 85-1150 NATURAL RESOURCES DEFENSE COUNCIL, INC., Petitioner, v. ENVIRONMENTAL PROTECTION AGENCY, et al., Respondents. On Petition for Review of an Action of the Environmental Protection Agency SUPPLEMENTAL BRIEF ON REHEARING FOR THE AMERICAN PETROLEUM INSTITUTE AS AMICUS CURIAE Of Counsel: G. William Frick Martha A. Beauchamp AMERICAN PETROLEUM INSTITUTE 1220 L Street, N.W. Suite 900 Washington, D.C. 20005 (202) 682-8248 April 13, 1987 Arthur F. Sampson, III John Gibson Mullan KIRKLAND & ELLIS 655 Fifteenth Street, N.W. Suite 1200 Washington, D.C. 20005 (202) 879-5066 Counsel for the American Petroleum Institute CTL028436 TABLE OF CONTENTS PRELIMINARY STATEMENT .............................................................................. I. SECTIONS 109 AND 112 BOTH NECESSARILY PERMIT THE ADMINISTRATOR TO TAKE ACCOUNT OF NON-HEALTH "POLICY" CONSIDERATIONS IN MAKING AN "ESSENTIALLY LEGISLATIVE" JUDGMENT ABOUT HOW TO PROTECT THE PUBLIC HEALTH AGAINST UNCERTAIN DANGERS.............................................................................. A. Congress Has Long Recognized That True Health Effects Thresholds Are Rare and Prescribed "Margins of Safety" To Authorize "Pragmatic Judgments." ...................... B. By Weighing "the Relative Acceptability of Various Degrees of Uncertainty," EPA's "Margin of Safety" Decisions Under Section 109 and Elsewhere Represent Exactly the Sort of "Pragmatic Judgments" Congress Authorized and Expected......................... C. In Light of the Foregoing Legislative and Administrative Background, Lead Industries. API and Hercules Cannot Fairly Be Read as Completely Prohibiting Practical Considerations.............. II. THE "MARGIN OF SAFETY" CONCEPT IS FLEXIBLE AND PROVIDES PLENTY OF ROOM FOR DIFFERENT APPROACHES TO IMPLEMENTING THE ACT'S OVER ARCHING PUBLIC HEALTH GOAL....................................................... A. As in Chevron. There Is No Basis for Imposing a "Static Judicial Definition" of the Phrase "Margin of Safety" Under the Clean Air Act................................................................. B. Because It Makes Public Health the "Paramount" Concern, EPA's Construction of Section 112 Is Fully Consistent With Congress' Intent and. In Fact, Provides a More Protective Safety Margin than the Section 109 Standards Previously Sustained by This Court................................................. CONCLUSION . .......................................................................................................... Page 1 4 7 10 14 17 18 22 24 CTL028437 - ii - TABLE OF AUTHORITIES Page CASES; Alabama Power Co. v. Costle. 204 U.S. App. D.C. 51, 636 F. 2d 323 (1980) .............................................. 19,21 American Petroleum Institute v. Costle. 214 U.S. App. D.C. 358, 665 F.2d 1176 (1981), cert, denied. 455 U.S. 1034 (1982) .............................. 2,14 American Textile Mfrs. Inst, v. Donovan. 452 U.S. 490 (1981) .............................................................................................. 6 ASARCO. Inc, v. EPA. 188 U.S. App. D.C. 77, 578 F.2d 319 (1978) ...................................................................... 19 Center for Auto Safety v. NHTSA. 253 U.S. App. D.C. 336, 793 F.2d 1322 (1986) ......................................... 22 Chevron U.S.A.. Inc, v. NRDC. 467 U.S. 837, reh'g denied. 468 U.S. 1227 (1984) .............................. 3,4,18 19,20 Environmental Defense Fund v. EPA. 194 U.S. App. D.C. 143, 598 F.2d 62 (1978) .............................................. 5,6 Ethvl Com v. EPA. 176 U.S. App. D.C. 373, 541 F.2d 1, (en banc), cert, denied. 426 U.S. 941 (1976) ............................................................................................... 5, 21 Hercules. Inc, v. EPA. 194 U.S. App. D.C. 172, 598 F.2d 91 (1978) ........................................................................ passim Industrial Union Dep't. AFL-CIO v. American Petroleum Inst. . 448 U.S. 607 (1980) ......................... 21 Industrial Union Dep't. AFL-CIO v, Hodgson. 162 U.S. App. D.C. 331, 499 F.2d 467 (1974) ................. 5,6 Lead Industries Ass'n v. EPA. 208 U.S. App. D.C. 1, 647 F.2d 1130, cert, denied. 449 U.S. 1042 (1980) .......................................................................................... passim National Ass'n of Demolition Contractors v. Costle. 184 U.S. App. D.C. 173, 565 F.2d 748 (1977) ............................................................................................... 20 Cases chiefly relied upon are marked with an asterisk. CTL028438 - Ill - NRDC v. EPA. ____ U.S. App. D.C. ____, 804 F.2d 710 (1986), vacated. ____ F.2d ____ (D.C. Cir. 1987) .............................................................................................. passim NRDC v. Gorsuch. 222 U.S. App. D.C. 268, 685 F.2d 718 (1982) ................................................................................. 19,20 Union Electric v. EPA. 427 U.S. 246 (1976), reh'g denied. 429 U.S. 873 (1976) ................................. 13 STATUTES: 42 U.S.C. 7411(h) ................................................................................... 42 U.S.C. 7416 (1982) ........................................................................ 42 U.S.C. 7470-79 ................................................................................ 21 7 9 LEGISLATIVE MATERIALS; H.R. Rep. No. 294, 95th Cong., 1st Sess. (1977) ____ S. Rep. No. 1196, 91st Cong., 2d Sess. (1970) .............. 123 Cong. Rec. 18460 (June 10, 1977) ...................................... 123 Cong. Rec. 18461 (June 10, 1977) ...................................... 123 Cong. Rec. 18463 (June 10, 1977) ...................................... 8, 9 7 8, 9 22 8, 9 MISCELLANEOUS; EPA, National Emission Standards for Vinyl Chloride, 41 Fed. Reg. 46560 (Oct. 21, 1976) .............................. 24 EPA, Toxic Pollutant Effluent Standards for Endrin, Toxaphene, and Other Compounds, 42 Fed. Reg. 2588 (Jan. 12, 1977) ................................. EPA, Toxic Pollutant Effluent Standards for Polychlorinated Biphenyls, 42 Fed. Reg. 6532 (Feb. 2, 1977) ....................................................................... 13,14 19 13 EPA, National Ambient Air Quality Standard for Lead, 43 Fed. Reg. 46246 (Oct. 5, 1978) ................. 10, 11, 12, 24 CTL028439 - iv - EPA, National Primary and Secondary Ambient Air Quality Standards for Ozone, 44 Fed. R g. 8202 (F b. 8, 1979) ...................................................................... 11. 12, ' 13, 24 National Academy of Sciences, Risk Assessment in the Federal Government; Managing the Process (1983) ......................................................................................................... 5 CTL028440 UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT ) NATURAL RESOURCES DEFENSE COUNCIL, INC.,) ) Petitioner, ) ) v. ) ENVIRONMENTAL PROTECTION AGENCY, et al. , ) Respondents. ) ) ----------------------------------------:) ) SUPPLEMENTAL BRIEF ON REHEARING FOR THE AMERICAN PETROLEUM INSTITUTE ______________AS AMICUS CURIAE No.85-1150 PRELIMINARY STATEMENT Congress, EPA and this Court have long understood that b cause there always is uncertainty in scientific data, pub lic health standards necessarily reflect value judgments weighing the risks of underprotection against the conse quences of overprotection. Dissatisfied with the policy judgment EPA made here, NRDC attempts "to erect" from previ ous court decisions "a policy of clear statement in environ mental statutes" which would preclude any consideration of pragmatic values "unless the statute expressly so pro vides." 1/ Because Section 112 of the Clean Air Act does 1/ NRDC v. EPA, 804 F.2d 710, 726 (D.C. Cir. 1986). vacat ed, ____ F.2d____ (D.C. Cir. 1987) ["Vinyl Chloride"]. This theme or variations of it appear throughout NRDC's Petition for Rehearing ["NRDC Pet.") and Brief on Rehearing ["NRDC Br."]. CTL028441 2- not specify what valu s may be weighed in evaluating the "margin of safety" to provide against uncertain dangers, NRDC reasons that Congress tacitly intended health to be "the only factor which EPA may consider." NRDC Br. at 4. The implication of this view, acknowledged only in foot notes, is that emissions bans are required in all cases where "known safe levels of exposure" cannot be identified. Id. at 27 n.50 (emphasis added); see also NRDC Pet. at 12 n.21. NRDC's reading of Section 112 depends on a bright line rule of construction which supposedly emerges' from previous decisions of this Court. 2/ According to NRDC, these cases preclude any consideration of practical concerns under other "margin of safety" statutes, including especially Sec tion 109 of the Act. API's supplemental brief focuses on this critical as- p ct of NRDC's challenge. 2/ As demonstrated below, none f 2/ NRDC cites Lead Industries Ass'n v. EPA, 647 F.2d 1130 (D.C. Cir.), cert, denied. 449 U.S. 1042 (1980) ["Lead In dustries"); American Petroleum Inst. v. Costle, 665 F.2d 1176 (D.C. Cir. 1981), cert, denied. 455 U.S. 1034 (1982) ("API"); and Hercules, Inc. v. EPA, 598 F.2d 19 (D.C. Cir. 1978) ["Hercules"). 3/ To be sure, NRDC also argues from the text and history of Section 112 itself. But as demonstrated in our first brief ["API/CMA Br."J and as found by the panel majority here, these sources come nowhere near establishing an affir mative legislative preclusion of practical values. API/CMA Br. at 14-32. To the extent NRDC's textual and historical arguments about Section 112 have any force at all, it is only because of the judicial gloss NRDC draws from decisions construing other "margin f safety" statutes. CTL028442 3 the C urt's pri r decisions supports NBDC's position. More over, under the principles announced in Chevron U.S.A.. Inc, v. NRDC. 467 U.S. 837 (1984), a "static judicial.definition" of the phrase "margin of safety" cannot be drawn from those decisions to override EPA's construction of Section 112. 4/ First, far from imposing implied limits on the policy considerations the Administrator may consider in establish ing "margins of safety" against uncertain harms, this C urt's decisions in Lead Industries. API and Hercules all hold that Congress left those choices to EPA. Under both Sections 109 and 112, Congress authorized the Administrator to formulate an "essentially legislative policy judgment" about what degree of uncertainty (i. e.. risk) is acceptable. In fact, the EPA "margin of safety" decisions reviewed in L ad Industries. API. and Hercules all reflect the kind of "pragmatic judgments" Congress expected the Agency to make in deciding how strictly to control pollutants which EPA found to lack "known safe" thresholds. For that and other r asons, those cases, which upheld EPA's decisions to set 4/ The question presented here is also involved, together with other aspects.of EPA's construction of Section 112, in two other cases. Nos. 84-1387 et al., and Nos. 84-1524 et al. (challenges to EPA Section 112 decisions on benzene and radionuclides, respectively). Argument in these cases has b en deferred pending a decision in this case. Because of its stake in the outcome here (among other things, API is a party in No. 84-1387), API sought and was granted leave to file a brief as amicus curiae with the panel, and the Court's Order dated February 27, 1987 invited amici curiae to file supplemental briefs on rehearing. CTL028443 non-zero standards allowing some residual risks, cannot fairly be read to hold that non-health valu s are forbidden in establishing "margins of safety." See Part I, infra. Second, whatever the correct reading of these cases. Chevron holds that EPA may adopt "different definitions in different contexts," "particularly [where] Congress has nev er indicated any disapproval of a flexible reading of the statute." Id. at 864. EPA's approach under Section 112 assigns "paramount" weight to public health values, and pro vides for infeasible standards, including even emissions bans, where residual health risks warrant, in the Adminis- / trator's judgment, an even greater margin of protection than the best controls can provide. Although different from EPA's approach to standard-setting under Section 109, this construction is entirely consistent with Congress' intent and, contrary to NRDC's assertion, is designed to provide a much more protective safety margin than the Agency's Sec tion 109 standards have achieved. See Part II, infra. I. SECTIONS 109 AND 112 BOTH NECESSARILY PERMIT THE ADMINISTRATOR TO TAKE ACCOUNT OF NON-HEALTH "POLICY" CONSIDERATIONS IN MAKING AN "ESSENTIALLY LEGISLATIVE" JUDGMENT ABOUT HOW TO PROTECT THE PUBLIC HEALTH AGAINST UNCERTAIN DANGERS. NRDC's position in this case is simple, though extreme. NRDC claims that Section 112 imposes a two-step process in which EPA must (i) identify a risk-free "threshold" level of exposure, and then (ii) set the standard far enough below that level to provide a "margin of safety." According to CTL028444 5 NRDC, EPA's job is confin d to a pur ly scientific analysis of the available health data, so that if a perfectly safe "threshold" cannot be found for a particular pollutant, EPA must ban it. NRDC Br. at 14-15, 27 n.50; NRDC Pet. at 10-11. The crucial flaw in this view is that scientific evi dence rarely, if ever, provides definitive answers about the health risks posed by environmental pollutants. The Nation al Academy of Sciences l"NAS"] has observed that all risk assessment is characterized by "pervasive uncertainty." Accordingly, "policy considerations" -- including "value judgments" about "the appropriate degree of conservatism" to apply in evaluating gaps and conflicts in the data -- "inev itably affect, and perhaps determine" the choices federal agencies must make in formulating standards to protect the t public health. 5/ This Court, too, has often recognized the inherent lim itations of science and the corresponding need for "value" or "policy" judgments in standard-setting. / Given "the 5/ NAS, Risk Assessment in the Federal Government: Managing the Process 11, 19, 33, 37 (1983). 6/ See, e.g.. Environmental Defense Fund v. EPA, 598 F.2d 62, 79-81, 83-85 (D.C. Cir. 1978) ("PCBs"]; Ethyl Corp. v. EPA, 541 F.2d 1, 24-25 (D.C. Cir.) (en banc), cert, denied. 426 U.S. 941 (1976); Industrial Union Dep't, AFL-CIO v. Hodgson, 499 F.2d 467, 474-75 (D.C. Cir. 1974). Both the majority and dissenting opinions in the panel decision here r cognized the inherent limitations of scientific research. Vinyl Chloride. 804 F.2d at 716, 722-23; id. at 735 n.4, 736 (Wright, J., diss nting). CTL028445 r 6- absence of any clear thr sholds," the Administrator's deci sions "necessarily . . . rest largely on policy Judgments." Lead Industries. 647 F.2d 1147, 1152. To make this "essen tially legislative" determination "concerning the relative risks of underprotection as compared to overprotection," Ethyl. 541 F.2d at 20 (quoting Hodgson. 499 F.2d at 475), EFA must "decide what inferences may be drawn" from the available data and "formulate policy with respect to what risks are acceptable." PCBs. 598 F.2d at 84 (emphasis add ed) . As developed below, Congress knew that EPA's "public health" and "margin of safety" decisions necessarily would involve "pragmatic judgments" about the acceptable degree of risk in each case, given the extent of uncertainty that harm may occur and the inevitable economic and social consequenc es of lower standards. 2/ Indeed, this truth about public health policymaking can readily be discerned in the EPA de cisions that were upheld by the cases NRDC relies on so heavily. Against this legislative and administrative back ground, none of those decisions can fairly be read to 7/ Whether or not informed by a formal accounting of costs and benefits, such a judgment essentially involves the form ulation of public policy by assigning values to the poten tial for harm and the effects of tighter controls. Contrary to NRDC's suggestion (NRDC Pet. at 4-5), neither EPA nor any party supporting the Agency's position contends that a formal cost-benefit analysis is required under Section 112. Therefore, American Textile Mfrs. Inst. v. Donovan, 452 U.S. 490 (1981), has no bearing on this case. See API/CMA Br. at 35-36. CTL028446 -7- foreclos practical considerations in establishing "margins of safety." A. Congress Has Long Recognized That True Health Effects Thresholds Are Rare and Prescribed "Margins of Safety" To Authorize "Pragmatic Judgments." Although NRDC attempts to read the phrase "margin of safety" as a mandate to eliminate all risk. Congress reject- d such an unrealistic approach. Congress understood that all health evidence involves uncertainty, but it did not command EPA to set standards eliminating a 1.1 risks regard less of the consequences. On the contrary, the "margin of safety" provision* enacted in 1970 were specifically intend ed to give the Administrator the latitude to define "a rea sonable degree of protection . . . against hazards which r search has not yet identified." / By 1977, seven years of standard-setting experience tinder both Sections 109 and 112 had confirmed the wisdom of this built-in flexibility. Adverting specifically to ambi ent pollutants regulated under Section 109, Congress ac knowledged that "the 'safe threshold' concept is, at best, a 8/ S. Rep. No. 1196, 91st Cong., 2d Sess. 10 (1970) ("1970 Senate Report"], reprinted in 1 Senate Comm, on Environment and Public Works, Legislative History of the Clean Air Act, at 410 ("Legis. Hist."] (emphasis added). Moreover, Con gress expected Section 109 standards to establish a "national health minimum" subject to the States' authority t set stricter standards. JId. (emphasis added); see 42 U.S.C. 7416 (1982). CTL028447 0 necessary myth" because the "limitations of present knowl edge" make it "impossible" to find a concentration "for any pollutant -- other than zero -- below which it is certain that no human beings will be adversely affected." 2/ As Senator Muskie succinctly put it, because "there is no such thing as a threshold for health effects," the Administrator "has had to make a pragmatic judgment" about the level of the standards. 10/ In fact, by 1977 widespread recognition of the safe threshold concept as a "myth" had touched off a heated leg islative debate over the adequacy of the existing ambient standards. 11/ In the end, however, Congress refused to 2/ H.R. Rep. No. 294, 95th Cong., 1st Sess. Ill, 112 ("1977 House Report"] (4 Legis. Hist, at 2578, 2579) (quoting NAS, Summary of Proceedings: Conference on Health Effects of Air Pollution at 7 (Nov. 1973)) (emphasis added). These limitations had long been apparent to those most familiar with the health evidence. Even in 1970, Senator Muskie understood that the existing "state of research" would not permit EPA to pinpoint "a certain threshold with out any harmful effect." See API/CMA Br. at 26 n.46. 10/ 123 Cong. Rec. 18460, 18463 (June 10, 1977) (3 Legis. Hist, at 1030, 1038) (emphasis added). Echoing the 1970 Senate Report (see note 8, supra). Senator Muskie acknow ledged that the ambient standards had been set "as the min imum necessary and the minimum reasonably attainable in the dirty air areas," and that more stringent standards "would impose unacceptable kinds of restrictions." Id. (3 Legis. Hist, at 1031, 1038). 11/ The 1977 House Report documents the emergence of data suggesting, at least to some observers, that the ambient standards promulgated in the early 1970's incorporated "small or virtually non-existent" safety margins. 1977 House Report at 105-28 (4 Legis. Hist, at 2572-95). For example, a "comprehensive review" of the health evidence led (Footnote Continued) CTL028448 9 mandat stricter standards. Instead, it r affirmed "the nec ssarilv judgmental element in th task of predicting future health risks," and endorsed the "pragmatic judgments" underlying EPA's "margin of safety" determinations: Some have suggested that since the standards are to protect against all known or anticipated ef fects and since no safe thresholds can be estab lished, the ambient standards should be set at zero or background levels. Obviously, this norisk philosophy ignores all economic and social consequences and is impractical. 12/ Indeed, instead of directing that the national stan dards be reduced to perfectly "safe" levels. Congress added a new Part C to Title I of the Act to "prevent significant deterioration" of air quality in attainment areas. 42 U.S.C. 7470-79 (1982). This "PSD" program was founded on the legislative determination that "adverse" health ef fects may "reasonably be anticipated to occur . . . notwith standing attainment and maintenance of all national ambient air quality standards." Jd. $ 7470(1) (emphasis added). Moreover, the PSD program was not designed to eliminate all residual health effects uncertainties but to ensure that "economic growth will occur . . . consistent with the pres ervation of existing clean air resources" and that "any de cision to permit increased air pollution" in attainment (Footnote Continued) a group of Johns Hopkins researchers to recommend a reduc tion in the Ambient Ozone Standard from 0.08 to 0.06 ppm. Id. at 108-09 (4 Legis. Hist, at 2575-76). 12/ 1977 House Report at 51, 127 ( mphasis added) (4 L gis. Hist, at 2518, 2594). CTL028449 10 areas would be made "only after a careful evaluation of all the consequences." .Id. 7470(3), (4). B. By Weighing "the Relative Acceptability of Various Degrees of Uncertainty," EPA's "Margin of Safety" Decisions Under Section 109 and Elsewhere Represent Exactly the Sort of "Pragmatic Judgments" Congress Authorized and Expected. Recognizing, as Congress did, that a "no risk philoso phy" is "impractical," EPA has repeatedly declined to set health standards at zero despite the absence of "known safe" thresholds. Indeed, pragmatic values demonstrably played a / role in the EPA "margin of safety" decisions upheld in the same cases which form the cornerstone of NRDC's challenge here. While that role was not inflexibly defined to mean precisely the same thing in every case, each of the deci sions undeniably reflects a practical policy judgment to ac cept some health risks in the face of scientific uncertain ty. In the preamble accompanying the Ambient Lead Standard affirmed in Lead Industries, for example, the Agency said that "protection of the public health" was EPA's "principal concern," but freely acknowledged that the standard realis tically could not completely "protect everyone" against any possibility of harm. 43 Fed. Reg. 46246, 46251 cols. 2, 3 (Oct. 5, 1970). In fact, the Agency prepared estimates in dicating, subject to various uncertainties, that some 20,000 young- children (the "sensitive population" the stan dard sought to protect) might xperience blood lead levels CTL028450 11 above the "thr shold" EPA posited for decisionmaking purpos es. 13/ To be sure, EPA insisted that "the standard is based on health considerations" and that economic and tech nical factors played no role. 24. at 46247 cols. 1, 3. 14/ Nevertheless, EPA rejected lower standards because they would require "exceptionally stringent" controls and con cluded that the standard selected would provide an "adequate margin of safety" because it would prevent "an unacceptable risk to health." 2d. at 46252 col. 1 (emphasis added), 46254 col. 2. / Likewise, in setting the Ambient Ozone Standard upheld in API, the Agency found that "a clear threshold of advers health effects cannot be identified with certainty for ozone." 44 Fed. Reg. 8202, 8213 cols. 1-2 (Feb. 8, 1979). While steadfastly maintaining that public health "must be 13/ 43 Fed. Reg. at 46255 cols. 2-3. EPA did not find that adverse effects would necessarily occur in children with blood lead levels of 30 yg Pb/dl. Rather, the Agency treated this as "the maximum safe blood lead level for chil dren" but recognized that whether certain blood-lead levels are "adverse to health" is "a question of the degree to which the effect has progressed." Id* 46253 col. 1, 46254 col. 3. While this meant that children with blood lead levels of 30 yg might suffer no adverse effects at all, the Agency could not definitively rule out the existence of any risk at that or even lower levels. Thus, EPA also esti mated that over 700,000 children could experience blood-lead levels above 15 to 20 yg Pb/dl, the lowest levels at which physiological changes had been observed in humans, but con cluded that these levels did not pose a "significant risk." Id. at 46253 col. 1 (emphasis added), 46255 col. 3. 14/ The Agency did prepare an impact analysis, however, which disclos d "no reason to expect imminent closure of any facility." Id. at 46251 col. 3. CTL028451 22 the compelling factor" and that the standard could not b based on "cost or attainability," the Administrator-never theless declined to adopt "a zero-level standard" because "controlling ozone to very low levels is a task that will have significant impact on economic and social activities." Id. (emphasis added). In fact, EPA decided to relax the previous standard Congress had reviewed extensively in 1977 lsee note 11, supra), even though the Agency itself credited studies showing some physiological responses, albeit of un certain health significance, below the new standard. 15/ As EPA put it, the revised standard was based-'on a judgment about "the relative acceptability" of "the uncertainty that any given level is low enough to prevent health effects." Id. (emphasis added). The pragmatic judgments inherent in EPA's "margin of safety" determinations are spelled out even more clearly in the decision approved in Hercules. There, EPA construed the Clean Water Act's "ample margin of safety" language to "al1 w[] a balancing test" under which feasibility is given 15/ According to EPA, physiological responses had been dem onstrated in both humans and experimental animals exposed b low the 0.12 ppm standard EPA chose. See 44 Fed. Reg. at 8214. API contended in the Ozone proceedings that such evi dence is not sufficient to justify the conclusion that adverse human health effects will occur at the 0.12 ppm level EPA selected for the standard (or even at higher 1 vels). Nor did the Agency make such a finding. Rather, it made a "judgment!] as to the point in the continuum of physiological responses to ozone that must be exceeded for an adverse health effect t occur." Id. at 8207 cl. 2. CTL028452 "some consideration" but decidedly "less weight" than " nvi- ronmental and public health factors." Toxaphene/Endrin Standard, 42 Fed. Reg. 2588 cols. 2-3 (Jan. 12, 1977). EPA specifically rejected NRDC's contention, repeated here, that Union Electric v. EPA. 427 U.S. 246 (1976), precludes con sideration of economic and technological factors in standard-setting. 16/ As in the Section 109 cases, EPA read "the statutory 'ample margin' concept [a]s an elastic one which . . . allows for considerable exercise of judgment by the Administrator in setting the standards." Ld. at 2597 col. 1. Typically, the Agency held, it would be appropriate to require as a minimum "the very best that control technol ogy can do" as a "logical break point" on the "spectrum ranging from certain safety (a prohibition) to the uncertain p int where harmful effects are caused and safety ends." Id. 17/ "Setting a standard at this point," EPA concluded. 16/ EPA stressed that unlike the "ministerial" review of state implementation plans l"SIPs") involved in Union Electric, the Administrator's task in setting standards under Section 307 "require{s] considerable exercise of dis cretion." EPA observed, moreover, that costs and feas ibility could be considered at "a number of points" before the final SIP review stage at issue in Union Electric, whereas Section 307 afforded no such earlier opportunity. 42 Fed. Reg. at 2596-97. 17/ The standards set under Section 307 of the Water Act illustrate the flexibility provided by the Administrator's interpretation of the "ample margin of safety" criterion. EPA banned PCB discharges because "the argument for a pro hibition based on considerations of toxicity is compelling." 42 Fed. Reg. 6532, 6550 col. 2 (Feb. 2, 1977). Neverthe less, EPA macie clear in the Toxaphene/Endrin decision that (Footnote Continued) CTL028453 14 "achi v s the purpose of the Act without inflicting unrea sonable and uniustifiabl conomic and social costs." Id. (emphasis added). C. In Light of the Foregoing Legislative and Administrative Background, Lead Industries. API and Hercules Cannot Fairly Be Read as Completely Prohibiting Practical Considerations. Although the pragmatic judgments described above were affirmed by this Court in Lead Industries. API and Hercules, these are the same cases that NRDC reads as foreclosing any c nsideration of costs or feasibility under- Section 112. NRDC's argument turns the holdings of these cases upside down. The industry petitioners in these cases asserted that EPA had a statutory duty to consider costs and feasibility in setting "margin of safety" standards and that the Agency had given too little weight to such considerations. 18/ In (Footnote Continued) Section 307 "does not require the zero discharge of every substance for which a cancer risk is found." JId. at 2588, 2592 col. 3. There, EPA set non-zero effluent standards for toxaphene and endrin because they were "considered suf ficiently stringent to provide an ample margin of safety." Id. at 2610 col. 2. 18/ See Lead Industries. 647 F.2d at 1148 ("St. Joe argues that the Administrator abused his discretion by refusing to consider" "the economic impact . . . and the technological feasibility of compliance," "and maintains that the . . . standards will have a disastrous economic impact"); Hercules. 598 F.2d at 110 ("Velsicol's principal argu ment ... is that EPA was required to" consider feasibility "but failed to do so adequately"): API, 665 F.2d at 1184 ("API . . . argues that EPA must consider whether the . . . standard is attainable and whether the anticipated costs of (Footnote Continued) CTL028454 r jecting th se challenges, this Court thrice refused to im pose limits on the Administrator's discretion when-Congress did not do so, holding that the values to be considered, and the weight to be assigned to each, were matters Congress left to the Administrator so long as the statute's overrid ing health goal is honored. See, e.q.. Lead Industries. 647 F.2d at 1146-47. Carefully scrutinized, the opinions in these cases sup port only the narrow conclusion required to sustain EPA's decisions -- i.e.. that technological feasibility need not t be a lower bound on "margin of safety" standards. The opin ions note the absence of any express mention of costs or feasibility in the statutory text (Lead Industries. 647 F.2d at 1148; Hercules. 598 F.2d at 111),, but that observation suggests at most that Congress did not mandate consideration of such factors. 19/ To find an affirmative preclusion based on silence alone would violate the key principle, ex pressed in Lead Industries itself, that the Court will not "impose limits on the Administrator's authority which, so far as we can tell. Congress did not." 647 F.2d at 1153. (Footnote Continued) meeting that standard are justified when compared with the results to be achieved"). 19/ The panel majority here agreed that the absence of such factors may well mean that Congress declined "to require" consideration of cost or feasibility but certainly "does not mean that Congress intended to preclude" consideration of them. Vinvl Chloride. 804 F.2d at 727 (emphasis added). CTL028455 16 In Lead Industries, the Court's refusal to interfer with th Administrator's judgment was bolstered by ther indicia of Congress' intent. The panel there relied on: (i) a contrast with a separate provision of the Act, Section 111, which makes feasibility a floor on the standards; 20/ (ii) Congress' intent that Section 109 standards be "tech nology-forcing" and its rejection "of the concept of techni cal feasibility m the basis of ambient air standards;" and (iii) the "preventive or precautionary nature" of the Act, xhorting "the Administrator ... to err on the side of caution." 647 F.2d at 1148-49, 1152-53 (emphaais added). These notions lent support to the Court's conclusion that EFA's policy judgment should not be overturned merely be cause the Agency did not give attainability and cost considrations as much weight as the industry petitioners would have preferred. But they fall far short of demonstrating an affirmative legislative intent to foreclose the considerati n of such values in deciding how great a "margin of safe ty" to provide against pollutants lacking "known safe" thresholds. 21/ 20/ See also Hercules. 598 F.2d at 111-112 & n.39. 21/ Indeed, the panel in Hercules recognized that EPA "did consider feasibility in the proceedings leading to the regu lations in issue" and, notwithstanding the absence of any challenge to the standards as too lax, went on to consider "the possibility that we must remand ... on the grounds that EPA took an erroneous step in its deliberations." 598 F.2d at 113. . The Court ultimately found a remand unneces(Fo tnote Continued) CTL028456 17 In sura, to read Lead Industries. H rcules and API as Imposing a c mplete prohibition on non-health considera tions, as KRDC does, would misapprehend the pragmatic char acter of the EPA decisions reviewed and the specific ques tions the Court was called upon to resolve. Such a reading simply cannot be reconciled with the Court's ultimate deci sion to defer to the Administrator's policy judgments in ach of these cases, and to affirm non-zero standards that deemed residual health risks "acceptable" in light of the practical consequences of stricter regulation. II. THE "MARGIN OF SAFETY" CONCEPT IS FLEXIBLE AND PROVIDES PLENTY OF ROOM FOR DIFFERENT APPROACHES TO IMPLEMENTING THE ACT'S OVERARCHING PUBLIC HEALTH GOAL. NRDC asserts that EPA's limited consideration of feasi bility under Section 112 "defies logic" because "it means that the provision which requires an 'adequate' margin of safety ( 109) is more protective of health than the provi sion which requires an 'ample' margin (5 112)." NRDC Br. at 11. As shown above, the premise of this argument is invalid because EPA is not forbidden to consider costs and feasibil ity in setting standards under Section 109 and has in fact exercised its discretion to consider pragmatic values in (Footnote Continued) sary because EPA did not relax the standards to ensure that they were feasible but merely observed that they "were, in fact, feasible." .Id. at 114. The Court found, in other words, that EPA did not compromise the overriding health goal for th sake of feasible standards. CTL028457 - 1G - Betting the standards upheld in Lead Industries and API. But even if NRDC's reading of those cases were correct, its conclusion remains wrong because EFA is under no obligation to interpret the phrase "margin of safety" inflexibly, and its construction of Section 112 in practice achieves a more protective safety margin than the Section 109 standards sus tained in those cases. Accordingly, EPA's construction of the statute is perfectly "logical" and fully consistent with Congress' intent. A. As in Chevron. There Is No Basis for Imposing a "Static Judicial Definition" of the Phrase "Margin of Safety" Under the Clean Air Act. Even if this Court's prior decisions affirmatively pre cluded practical considerations under Section 109, those decisions would not control EPA's interpretation of Sec tion 112. Lead Industries itself holds that "lt]he choice" among various "possible approaches" to providing a margin of safety "is a policy choice of the type that Congress specif ically left to the Administrator's judgment." 647 F.2d at 1162. Indeed, Chevron establishes that the courts lack au thority to "adopt a static judicial definition" of a statu tory term when "Congress itself ha[s] not commanded that definition." 467 U.S. at 842. NRDC's argument here is strikingly similar to the one r jected in Chevron. There, a panel of this Court ruled that EPA was'required to adopt, under a Clean Air Act pro gram designed t improv air quality, a stricter definition CTL028458 of th statutory term "source" than was permissible in a program designed only to maintain existing air quality. NRDC v. Gorsuch. 685 F.2d 718 (D.C. Cir. 1982). Although conceding that EPA's definition was not foreclosed by the language of the statute, the panel felt compelled to follow this "bright line" distinction because previous decisions had inferred it from the structure and purposes of the Act. 22/ The Supreme Court reversed, noting that the distinction drawn in the earlier cases "may well be a sensible one," but was "not a distinction that Congress ever articulated." 467 U.S. at 864. The Court upheld EPA's interpretation be cause: (i) both the statute and the legislative history were "silent on the precise issue" presented; and (ii) "Con gress ha[dl never indicated any disapproval of a flexible reading of the statute." Id. at 862, 864. NRDC's effort to draw from Lead Industries. API and Hercules a "static judicial definition" of the phrase "mar gin of safety" should be rejected for the same reasons. The 22/ Id. at 720, 726 (citing ASARCO, Inc. v. EPA, 578 F.2d 319 (D.C. Cir. 1978), and Alabama Power Co. v. Costle, 636 F.2d 323 (D.C. Cir. 1980)). The Gorsuch panel "ex press! ed] no view on the decision {it] would reach if the line drawn in Alabama Power and ASARCO did not control [its] judgment." Id. at 720 n.7. CTL028459 20 Act do s not ven define th term "margin of safety," much 1 as affirmatively exclud practical considerati ns. 23/ Even the dissent was unwilling to accept NRDC's abso lutist interpretation of Congressional silence. 24/ Indeed, the dissent apparently was prepared to conclude that the Conference Committee's substitution of "margin of safety" standards for the prohibition in the Senate bill supports an authority "to consider feasibility" under Section 112. 804 F.2d at 734. The dissent rejected this conclusion only be cause of the simultaneous insertion of the presidential waiver provision in Section 112(c)(2), which the dissent thought "unnecessary unless the 'ample margin of safety' language otherwise bars consideration of available technolo gy." Id. Section 112(c)(2) would be "unnecessary," 23/ See Vinyl Chloride. 804 F.2d at 716; API/CMA Br. at 17-22. Apparently NRDC's new "policy of clear statement in environmental statutes" operates selectively, because NRDC is willing to infer the existence of some powers but not others. For example, although reading the statute to ex clude consideration of practical factors by negative impli cation, NRDC eagerly supports an authority to prohibit emis sions which is not expressly granted in Section 112, even though Section 307 of the Water Act reveals that Congress knew full well how to do so. See Hercules. 598 F.2d at 97 n.l. Nor is there any express mention of the authority, upheld by this Court in National Ass'n of Demolition Con tractors, Inc. v. Costle, 565 F.2d 748 (D.C. Cir. 1977), to consider the safety trade-offs of stricter Section 112 standards. 24/ Rejecting NRDC's position that an emissions ban is re quired whenever a "known safe" threshold is not found, the dissent reiterated the "well established" proposition that the Administrator could decline to regulate "insignificant" risks despite the absence of any express authority. Vinvl Chloride. 804 F.2d at 736-37. CTL028460 21 how v r, only if Section 112 standards must always be feasi ble. 25/ B cause EPA claims th latitude t adopt inf asible standards where necessary to protect public health, non f the structural considerations or historical remarks iden tified by NRDC and the dissent is inconsistent with EPA's interpretation of the statute. 26/ Nor has there been any Congressional "disapproval" of EPA's flexible reading of the "margin of safety" requirement under Sections 112 and 109. Whether or not Congress can be said to have ratified EPA's approach during the 1977 Amend ments to the Act (see API/CMA Br. at 27-32;* pp. 8-10, su pra), the legislative history is not even directionally con sistent with the kind of "clear mandate" that would be need- d to accept the far-reaching consequences of NRDC's extrem construction. See Industrial Union Deo't. AFL-CIO v. 25/ Similarly, NRDC claims that the "restrictive" defini tion of "feasible" in Section 112(e) "would make no sense if EPA were already authorized to consider a more general notion of feasibility when setting standards." NRDC Br. at 19. Yet, a provision nearly identical to Section 112(e) appears in Section 111, where EPA is required to set feasible standards. See 42 U.S.C. 7411(h) (1982). 26/ Moreover, practical concerns must be involved at some level in any decision to disregard a risk as "insignifi cant." For "how can [the Administrator] assess risks if he cannot make policy judgments?" Ethyl. 541 F.2d at 20. In the dissent's own words, the Administrator can decide which " xpenditures of effort" are "pointless" and when the "gain[s]" of further control are "trivial or of no value." Vinyl Chloride. 804 F.2d at 736 (quoting Alabama Power. 636 F.2d at 360-61). CTL028461 22 Am rican Petroleum Inst.. 448 U.S. 607, 645 (1980); API/CMA Br. at 14-17. B. Because it Makes Public Health the "Paramount" Concern, EPA's Construction of Section 112 Is Fully Consistent With Congress' Intent and, in Fact, Provides a More Protective Safety Margin than the Section 109 Standards Previously Sustained by this Court. Contrary to NRDC's approach of finding preclusions based solely on Congressional silence, this Court has re cently held that an agency may consider factors not "specif ically designated" by Congress so long as "the weight given" t such factors does not fall "outside the range" of the agency's policymaking discretion and the "overarching" goals of the statute are honored. 27/ Indeed, as Center for Aut Safety makes plain, an agency may even rely upon a factor that Congress rejected as the sole basis for setting stan dards, at least where the statutory criteria "are broad enough to encompass" it. 793 F.2d at 1338, 1339. As demonstrated above, the very nature of setting health standards in the face of scientific uncertainty re quires some consideration of non-health concerns, and 27/ Center for Auto Safety v. NHTSA, 793 F.2d 1322, 1340-41 (D.C. Cir. 1986); accord Hercules. 598 F.2d at 107, 109 ("zone of reasonableness" test); cf. 123 Cong. Rec. 18461 (3 Legis. Hist, at 1031) ("The constraints . . . which resulted in the present primary standards still exist. The necessity for balancing health requirements against the need for growth still exists.") (remarks of Sen. Muskie). CTli028 462 23 Congr ss enacted th "margin of eaf ty" requirement for the express purpose f dir cting the Administrator to make the n cessary value judgments. What is more, EPA's construction of Section 112 does, in fact, honor Congress' "overarching" public health goal. Specifically, EPA consistently makes public health the "paramount" consideration in setting standards and considers cost, feasibility and other non-health factors solely to assist in judging where along the continuum of uncertainty to set a standard. See API/CMA Br. at 2-10. But in con trast to Section 109, where the Agency has. generally assumed the existence of a health effects threshold as a "necessary myth" even in the face of contrary evidence, under Sec tion 112 EPA makes the extremely conservative assumption that any level of exposure presents some risk, at least for carcinogens. Jd. at 4-6. Moreover, EPA's approach contem plates standards requiring more than what is feasible, in cluding emissions bans, where necessary to protect the pub lic health from unacceptable risk, which EPA assesses using a "plausible upper limit" methodology that may overstate the true risk by a factor of 100, 1,000, or even more. 6-10. Id. at The end result is a more protective margin of safety, directed, of course, at a more serious potential harm. Al though the Section 109 standards have been set near (if not within) the range of exposures within which there was some evidence that adverse effects might occur, (s e pp. 11-13, CTL028463 24 supra). public exposur s r maining after complianc with S cti n 112 standards are far below any levels shown t cause harm. 28/ The estimated risk under the Vinyl Chlorid Standard, for example, is less than 1-in-a-million, over 10,000 times smaller than the risk remaining under the Ambi ent Lead Standard. 29/ Thus, unlike NRDC's impractical vi sion of setting standards at zero under both Sections 109 and 112 whenever "known safe" thresholds cannot be found, EFA's construction gives real meaning to the statutory dis tinction between "adequate" and "ample" safety margins. CONCLUSION NRDC's petition attempts to portray the panel ruling here as a "drastic departure from settled Judicial interpre tation of the Clean Air Act," which "will have major adverse consequences for public health protection," "cloud[] the meaning of other public health laws," and "effectively strip!J Congress of control over agency action." NRDC Pet. 28/ In the case of vinyl chloride, for example, EPA found no evidence of adverse health effects at the ambient concen trations that prevailed even before the 95 percent emission reduction mandated by the standard. See API/CMA Br. at 8-9; 41 Fed. Reg. 46560 col. 2 (Oct. 21, 1976). 29/ Id. at 46560 col. 2 (calculations indicating an upper limit risk of about 0.2 per million under the standard). The Ambient Lead Standard, in contrast, was designed to pro tect 99.5 percent of the "most sensitive" population, and therefore left a risk of 0.05 percent, or l-ln-200. 43 Fed. Reg. at 46252 col. 2. The Ambient Ozone Standard was simi larly designed to protect the 99th percentile of the most sensitive population group. 44 Fed. Reg. at 8215 col. 3. CTL028464 25 at 1, 2, 3. Yet EPA's approach to standard-setting under Section 112 has remain d ssentially the sam during nearly seventeen years of implementation by four different Adminis trations, without so much as a hint of Congressional disap proval. See API/CMA Br. at 27-32; compare Chevron. 467 U.S. at 857-60, 863-64. Moreover, the Agency's pragmatic ap proach to establishing "margins of safety" against uncertain harms has consistently been upheld by this Court. For the reasons set forth above and in our first brief, we submit that the panel majority here was correct when it concluded that EPA may give "incidental consideration [to] non-health factors" so long as public health remains "the overriding consideration under [its] construction of sec tion 112." 804 F.2d at 726. Respectfully submitted. Of Counsel: G. William Frick Martha A. Beauchamp AMERICAN PETROLEUM INSTITUTE 1220 L Street, N.W. Suite 900 Washington, D.C. 20005 (202) 682-8248 April 13, 1987 Arthur F. Sampson, III John Gibson Mullan KIRKLAND & ELLIS 655 Fifteenth Street, N.W. Suite 1200 Washington, D.C. 20005 (202) 879-5066 CTL028465 CERTIFICATE OF SERVICE I hereby certify that on April 13, 1987'two copies of the foregoing Supplemental Brief on Rehearing for the American Petroleum Institute as Amicus Curiae were served by hand on the following: David D. Doniger, Esquire Natural Resources Defense Council, 1350 New York Avenue, N.W. Suite 300 Washington, D.C. 20005 Inc. Stephen L. Samuels, Esquire Environmental Defense Section Land and Natural Resources Division U.S. Department of Justice P.0. Box 23986 New Post Office Building 10th & Pennsylvania Avenue, N.W. Washington, D.C. 20026-3986 Earl Salo, Esquire Office of General Counsel Air and Radiation Division U.S. Environmental Protection Agency 401 M Street, S.W. Room 527-B, West Tower (LE-132A) Washington, D.C. 20460 Peter L. de la Cruz, Esquire Keller & Heckman 1150 17th Street, N.W. Suite 1000 Washington, D.C. 20036 Robert Brager, Esquire Beveridge & Diamond, P.C. 1333 New Hampshire Avenue, Washington, D.C. 20036 N.W. John Gibson Mullan CTL028466