# Petition for Writ of Certiorari — E. I. du Pont de Nemours & Co. v. Environmental Protection Agency > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385609_0192%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition for Writ of Certiorari - **Published:** January 1, 1976 - **Citation:** 426 U.S. 941 ## Text ef sulreme CLOUTT U Da | - La ia — nae ’ t * IN THE Supreme Court of the Cited States OCTOBER TERM, 1975. - 75-1613 NALCO CHEMICAL COMPANY, Petitioner, VS. ENVIRONMENTAL PROTECTION AGENCY, Respondent. PETITION FOR WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT. Victor P. KAYSER, JOHN C. BERGHOFF, Jr., 135 South LaSalle Street, Chicago, Illinois 60603, DaviD MACHANIC, WILLIAM H. FITZ, 1200 18th Street, N. W., Washington, D. C. 20036, Attorneys for Petitioner. Of Counsel: CHADWELL, KAYSER, RUGGLES, McGEE & HASTINGs, 135 South LaSalle Street, Chicago, Illinois 60603, (312) 726-2545, PIERSON, BALL & Down, 1200 18th Street, N. W., Washington, D. C. 20036, (202) 331-8566. Gunthorp-Warren Printing Company, Chicago e Financial 6-6565 Sietat eta ol TABLE OF CONTENTS. PAGE I Cc Vicna lee tai Coe ete eS 1 MI ies x Vids FL ewes Cae Oa ee hc eae oe 2 SINE oy yao doen eduh cs ewdcyiee nus 2 Statutes and Regulations Involved .................. 3 UN GE TE. iwi Dh ehh aay cdacesaadeuks 3 Chronology of the Regulations ................. 3 I Se ce iN wads dene Owe ews 5 Reasons for Granting the Writ ....... 2... ...002000. 7 I. The Lower Court Unjustifiably Attributed Inherent Discretion in the EPA to Regulate, Despite a Limited Congressional Grant of Authority ...... A. Threshold Determination ................ B. Lepeistive Mistery .........0.sencseca 10 C. Comparison with Other Sections .......... 11 D. Generalized Attribution of Discretion ...... 12 Il. The Lower Court Unjustifiably Limited the Scope of Its Review Because This Case Involved Environ- IT SE ee a at cance eas 15 A. The Conflict Within the Lower Court as to PU Se NE 5. vce bonne euaicies 15 B. The Record Does Not Support the Regulation and Its Promulgation Constitutes a Clear Error AP I hf ses be ee fase oes ee 19 If]. The Regulation Should Be Set Aside or Remanded to the EPA Because of Failure to Provide Mean- ingful Opportunity for Comment .............. 22 AE oo 6 ha. k be wee ee wea cee a Ae ee ee 30 Ce ee eee eer ee err ee eek nt Al ND koh veka oo ccs eRe eae ee ewer Bl DHAMnRD COHOPRPY TABLE OF AUTHORITIES. Cases. Amoco Oil Co. v. EPA, 501 F. 2d 722 (D. C. Cir. 1974) SE NaIE Sadi tactnas excita Sacer lice Seas aati GAG as enn sala: 4,9, 10 Austin v. Jackson, 353 F. 2d 910 (Sth Cir. 1965) ...... 23 Bowman Transportation v. Arkansas-Best Freight System, We 20 Burlington Truck Lines, Inc. v. United States, 371 U. S. ih eee eae ti ep oa 6 iad ode 17 Camp v. Pitts, 411 U.S. 138 (1973) ............00-. 28 Citizens to Preserve Overton Park v. Volpe, 401 U. S. } I eee ceieg reer a ln Gay os vce dees 17,19 : Environmental Defense Fund, Inc. v. EPA, 465 F. 2d i ee exo ce a adc mews pnuw es 13, 19, 23 / Environmental Defense Fund, Inc. v. EPA, 510 F. 2d 1292 a I ea are seer kh noms two wes eww 8 13 3 Environmental Defense Fund, Inc. v. Ruckelshaus, 439 : F. 2d 584 (D.C. Cir. 1971) ............005. 16, 17, 20 Great Lakes Screw Corp. v. NLRB, 409 F. 2d 375 (7th : ee ee ack i ww kleié nadine 23 : Greater Boston Television Corp. v. FCC, 444 F. 2d 841 (D. C. Cir.), cert. denied, 403 U. S. 923 (1971) ....17, 20 Hertz v. Woodman, 218 U. S. 205 (1910) ............ 19 Hess & Clark Div. of Rhodia, Inc. v. FDA, 495 F. 2d 975 ae i sb dias ee wplvie k we 6 ab a 23 Homan v. United States, 279 F. 2d 767 (8th Cir.), cert. denied, 364 U. S. 866 (1960) ................... 18 Hotch v. United States, 212 F. 2d 280 (9th Cir. 1954) .. 26 BLEED THROUGH Industrial Union Dept., AFL-CIO v. Hodgson, 449 F. 2d ee NN abies hoa cao oceans 13 International Harvester Co. v. Ruckelshaus, 478 F. 2d 615 Oe eS NN nd ccc awake 8 dee ecdan 16, 17, 23 Kennecott Copper Corp. v. EPA, 462 F. 2d 846 (D. C. I ne er ON ee Ue 20, 23 Portland Cement Ass’n v. Ruckelshaus, 486 F. 2d 375 (D. C. Cir. 1973), cert. denied, 417 U. S. 921 (1974) ee ee ar 17, 20, 23 Reserve Mining Co. v. EPA, 514 F. 2d 492 (8th Cir. ay ed OS ON OCR SET ON are er ae 13,14 Rodway v. U. S. Dept of Agriculture, 514 F. 2d 809 (D.C. I ahs Pei a careers suk we oe oe La bs 20, 22 SEC v. Chenery Corp., 332 U. S. 194 (1947) ........ 20 Sierra Club v. Morton, 405 U. S. 727 (1972) ........ 16 Society of the Plastics Indus., Inc. v. OSHA, 509 F. 2d 1301 (2d Cir.), cert. denied, 421 U. S. 992 (1975) ... 13 South Terminal Corp. v. EPA, 504 F. 2d 646 (1st Cir. cn ARES OR Re Om rr eet ra ne 23 United States v. American-Foreign SS. Corp., 363 U. S. I aa es alle pi cued ee ho: 18 United States ex rel. Robinson v. Johnston, 316 U. S. oR RS I i yee a ie 18 Universal Cameia Corp. v. NLRB, 340 U. S. 474 (1951) 17 Wagner Elec. Corp. v. Volpe, 466 F. 2d 1013 (3d Cir. ile APRA GE Sah ERCSEY Sevier in ge orien Get Rene SO ee 26 Walter Holm & Co. v. Hardin, 449 F. 2d 1009 (D. C. I eu alee whee ee as ew ie a et 23, 26 POOR COPY attic LA PLT Ree gia PSS Hae Ye apie ae ene a eS EBON ry 0g EM TEE Be Ms Se non iv Statutes. Administrative Procedure Act: Be as Nie a eee 48 have the opportunity for leisurely and isolated scrutiny of an entire mechanism. Awaiting certainty will often allow for only reactive, not preventive, regulation.” Pe- titioners suggest that anything less than certainty, that any speculation, is irresponsible. But when statutes seek to avoid environmental catastrophe, can preventive, albeit uncertain, decisions legitimately be so labeled? The problems faced by EPA in deciding whether lead automotive emissions pose a threat to the public health on probabilities that statistically constitute “certainties.” See generally T. KUHN, THE STRUCTURE OF SCIENTIFIC REVOLU- TIONS. While awaiting such statistical certainty may consti- tute the typical mode of scientific behavior, its appropriate- ness is questionable in environmental medicine, where regu- lators seek to prevent harm that often cannot be labeled “cer- tain” until after it occurs. See note 58 infra. The uncertainty of scientific fact parallels the uncertainty of all fact. In a metaphysical sense, at least, facts are them- selves nothing more than risks, or statistical probabilities. See D. HUME, A TREATISE OF HUMAN NATURE, bk. I, pt. III, § 6, at 87 (L.A. Selby-Bigge ed. 1958). °? Thus this court, per Judge Wilkey, affirmed EPA’s gen- eral ban on the use of DDT even though the evidence was considerably less than certain: [T]here is a great mass of often inconsistent evidence which was developed at the hearing; this evidence is substantial enough to support the conclusions of the Ad- ministrator, although it possibly might support contrary conclusions as well. Considering the evidence as a whole, we cannot say that the Administrator’s decision was not based on substantial evidence, even if the hazardous nature of DDT has not been proved beyond a reasonable doubt. Sufficient evidence has been adduced to show potentially great dangers from DDT, and the Adminis- trator’s decision to cancel the DDT registration is well within his statutory authority. Environmental Defense Fund, Inc. Vv. EPA (Coahoma), su- pra note 28, 160 U.S.App.D.C. at 128, 489 F.2d at 1252 (em- phasis added). 49 highlight the limitations of awaiting certainty. First, lead concentrations are, even to date, essentially low- level, so that the feared adverse effects would not ma- terialize until after a lifetime of exposure. Contrary to petitioners’ suggestion, however, we have not yet suf- fered a lifetime of exposure to lead emissions. At best, emissions at present levels have been with us for no more than 15-20 years.** Second, lead exposure from the ambient air is pervasive, so that valid control groups cannot be found against which the effects of lead on our population can be measured. Third, the sources of human exposure to lead are multiple, so that it is difficult to isolate the effect of automobile emissions. Lastly, significant exposure to lead is toxic, so that con- siderations of decency and morality limit the flexibility of experiments on humans that would otherwise accele- rate lead exposure from years to months, and measure those results.” Cf. Environmental Defense Fund, Ine. v. EPA (Shell), 167 U.S.App.D.C. 71, 78, 510 F.2d 1292, 1299 (1975). The scientific techniques for attempting to overcome these limitations are several: toxicology can study the distribution and effect of lead in animals; epidemiological techniques can analyze the effects of lead emissions on entire populations; clinical studies can reproduce in *% According to the NAS Panel, present air lead concentra- tions, which over the largest American cities are 2,000 times greater than air lead concentrations over the mid-Pacific Ocean, have existed for 15 years. NAS Report at 205, JA 356. The Panel attributed these high concentrations primarily to automotive emissions. /d. °° It is for these reasons that, although lead additives have been used for over 50 years, the danger posed by lead emis- sions is still a question “on the frontiers of scientific know]- edge.” Industrial Union Department, AFL-CIO v. Hodgson, supra note 49, 162 U.S.App.D.C. at 338, 499 F.2d at 474. See note 97 infra. 50 laboratories atmospheric conditions and measure under controlled circumstances the effects on humans. All of these studies are of limited usefulness, however. Dr. J. H. Knelson, Director of EPA’s Human Studies Lab- oratory, has described, in the context of setting ambient air standards, the limitations of these various investiga- tive tools: Each of these investigative approaches—classic toxicology, epidemiology, and clinical research has its advantages and disadvantages. The toxicologist can control the dose and use invasive or destructive techniques in measuring response in the animal, but is always faced with the problem of extrapolating results to humans. Epidemiology is most relevant because it studies phenomena actually occurring in humans under “natural” conditions, but can only draw inference from observed correlations rather than prove cause and effect relationships. Clinical research can provide the most accurate dose- response relationships in the species of interest. Precisely because the study subjects are humans, however, many experimental design problems are encountered in assuring their safety. Although the dose of an atmospheric pollutant can be carefully controlled and measured in the clinical laboratory, qualitative comparability to the multiplex variable of atmospheric pollution cannot always be assured. The best scientific criteria for establishing air quality standards result from interactions between these disciplines. Clinical studies must be preceded by exhaustive toxicological assessment in other species; observations from population studies should play an important role in the experimental design of clinical research. Biomedical data from all these sources, taken in their entirety, should be used for the prudent definition of air pollution control needs. JA 582-583. The best biomedical evidence will be de- rived from relating all three research approaches. This EPA did. That petitioners, and their scientists, find a BLEED THROU GH 51 basis to disagree is hardly surprising, since the results are still uncertain, and will be for some time. But if the statute accords the regulator flexibility to assess risks and make essentially legislative policy judgments, as we believe it does, preventive regulation based on conflict- ing and inconclusive evidence may be sustained. Recent cases have recognized this flexibility in similar situations. In Industrial Union Department, AFL-CIO v. Hodg- son, supra, this court considered the Secretary of Labor’s delegated power under the Occupational Safety and Health Act (OSHA), 29 U.S.C. § 651 et seg., to protect the health of industrial workers by setting standards for exposure to industrial pollutants. Under review was a standard for exposure to asbestos dust, thought to be carcinogenic. Judge McGowan, writing for the division, laid down the rule: From extensive and often conflicting evidence, the Secretary in this case made numerous factual de- terminations. With respect to some of those ques- tions, the evidence was such that the task consisted primarily of evaluating the data and drawing con- clusions from it. The court can review that data in the record and determine whether it reflects sub- stantial 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 analy- sis.** 18 Where existing methodology or research in a new era of regulations is deficient, the agency necessarily enjoys broad discretion to attempt to formulate a solution to the best of its ability on the basis of available informa- tion, Permian Basin Area Rate Cases, 390 U.S. 747, 811, 88 S.Ct. 1344, 20 L.Ed.2d 312 (1968). 162 U.S.App.D.C. at 338, 499 F.2d at 474. POOR COPY 52 This rule was likewise applied in The Society of the Plastics Industry, Inc. v. OSHA, 509 F.2d 1301 (2d Cir.), cert. denied, 421 U.S. 992 (1975), where the Second Circuit reviewed regulations limiting industrial exposure to vinyl chloride, also considered a carcinogen: As in Industrial Union Department, AFL-CIO v. Hodgson, supra, the ultimate facts here in dispute are “on the frontiers of scientific knowledge,” and, though the factual finger points, it does not con- clude. Under the command of OSHA, it remains the duty of the Secretary to act to protect the work- ingman, and to act even in circumstances where existing methodology or research is deficient. The Secretary, in extrapolating the MCA study’s finding from mouse to man, has chosen to reduce the per- missible level to the lowest detectable one. We find no error in this respect. Id. at 1308. And in Reserve Mining the Eighth Cir- cuit agreed. Although reviewing the determination of a District Court, not an expert Administrator, the court recognized that it must nonetheless apply the test of the preventive statute before it: |W]e note that many of the issues in this case do not involve “historical” facts subject to the ordinary means of judicial resolution. Indeed, a number of the disputes involve conflicting theories and experi- mental results, about which it would be judicially presumptuous to offer conclusive findings [quoting Amoco Oil Co. v. EPA, 163 U.S.App.D.C. 181, 501 F.2d at 741, which relied on Industrial Union}. In Such circumstances, the finder of fact must accept certain areas of uncertainty, and the findings them- selves cannot extend further than attempting to as- sess or characterize the strengths and weaknesses of the opposing arguments. 514 F.2d at 507 n.20. See also id. at 529. norrcrcre Fat. Bilas et 53 These cases, recognizing as they do the developing nature of environmental medicine, fortify our analysis of the “will endanger” language of Section 211.°° Where a statute is precautionary in nature,” the evidence dif- * Ethyl argues that Industrial Union and Society of the Plastics Industry are distinguishable from this case in that under OSHA the Secretary is directed to set standards for in- dustrial exposure to toxic substances, 29 U.S.C. § 655(b) (5), while action under § 211 is discretionary with the Adminis- trator. Ethyl Supp. Br. at 28-30. Ethyl has merely identified the source of the flexibility granted the Secretary, while failing to set the cited cases apart from this one. Under the Clean Air Act the Administrator’s flexibility is derived not from a command to act, but from a precautionary statute that necessarily includes risk assessment if its preventive purpose is to be achieved. Since there is reason to accord flexibility to the regulator under both acts, the cited cases are good support for the way in which that flexibility is to be exercised. Nalco asserts that the cases are distinguishable in that Industrial Union and Society of the Plastics Industry involve the manner in which standards are set under OSHA, rather than the Secretary’s power to set standards at all. Nalco Supp. Br. at 12. This purported distinction is no more than a factual difference between the cases. Flexibility is necessary under OSHA only in the manner of setting standards, since the command to set standards is clear. Under the Clean Air Act, on the other hand, flexibility is necessary both in standard-setting and in deciding whether to regulate. The teaching of the cases is nonetheless applicable. Reserve Mining shows the spurious nature of both asserted distinctions. In that case, as here, there was no command to regulate, only a statutory term of a precautionary nature— “endangering”—to justify flexibile decision-making (in Re- serve Mining by a court rather than by an agency). Like- wise, that case involved not only the manner of standard- setting, but the threshold decision to regulate as well. None- theless, Reserve Mining is fully consistent with Industrial Union and Society of the Plastics Industry, and all three cases support our conclusion here. * Or, as with OSHA, mandatory in its command to act. See note 56 supra. Da an oa an A od a toe » 54 ficult to come by, uncertain, or conflicting because it is on the frontiers of scientific knowledge, the regulations designed to protect the public health, and the decision that of an expert administrator, we will not demand rigorous step-by-step proof of cause and effect. Such proof may be impossible to obtain if the precautionary purpose of the statute is to be served. Of course, we are not suggesting that the Administrator has the power to act on hunches or wild guesses. Amoco makes it quite clear that his conclusions must be rationally justified. Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 180- 181, 501 F.2d at 740-741. However, we do hold that in such cases the Administrator may assess risks. He must take account of available facts, of course, but his in- quiry does not end there. The Administrator may apply his expertise to draw conclusions from suspected, but not completely substantiated, relationships between facts, from trends among facts, from theoretical projections from imperfect data, from probative preliminary data not yet certifiable as “fact,” and the like. We believe that a conclusion so drawn—a risk assessment—may, if rational, form the basis for health-related regulations under the “will endanger” language of Section 211.” °° It bears emphasis that what is herein described as “‘assess- ment of risk” is neither unprecedented nor unique to this area of law. To the contrary, assessment of risk is a normal part of judicial and administrative fact-finding. Thus EPA is not attempting to expand its powers; rather, petitioners seek to constrict the usual flexibility of the fact-finding process. Petitioners argue that the Administrator must decide that lead emissions “will endanger” the public health solely on “facts,” or, in the words of the division majority, by a “chain of scientific facts or reasoning leading [the Administrator] ineluctably to this conclusion * * *.” Division op. at 59. Peti- tioners demand sole reliance on scientific facts, on evidence that reputable scientific techniques certify as certain. Typi- cally, a scientist will not so certify evidence unless the prob- BLEED THR OUGH 55 All of this is not to say that Congress left the Ad- ministrator free to set policy on his own terms. To the contrary, the policy guidelines are largely set, both in the statutory term “will endanger” and in the relation- ability of error, by standard statistical measurement, is less than 5%. That is, scientific fact is at least 95° certain. Such certainty has never characterized the judicial or the administrative process. It may be that the “beyond a reason- able doubt” standard of criminal law demands 95‘ cer- tainty. Cf. McGill v. United States, 121 U.S.App.D.C. 179, 185 n.6, 348 F.2d 791, 797 n.6 (1965). But the standard of ordinary civil litigation, a preponderance of the evidence, de- mands only 51% certainty. A jury may weigh conflicting evidence and certify as adjudicative (although not scientific) fact that which it believes is more likely than not. Since Reserve Mining was adjudicated in court, this standard applied to the court’s fact-finding. Inherently, such a standard is flexible; inherently, it allows the fact-finder to assess risks, to measure probabilities, to make subjective judgments. None- theless, the ultimate finding will be treated, at law, as fact and will be affirmed if based on substantial evidence, or, if made by a judge, not clearly erroneous. The standard before administrative agencies is no less flexible. Agencies are not limited to scientific fact, to 95% certainties. Rather, they have at least the same fact-finding powers as a jury, particularly when, as here, they are engaged in rule-making. Looking to the future, and commanded by Congress to make policy, a rule-making agency necessarily deals less with “evidentiary” disputes than with normative con- flicts, projections from imperfect data, experiments and simulations, educated predictions, differing assessments of possible risks, and the like. Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 175, 501 F.2d at 735. An agency’s finding of fact differs from that of a jury or trial judge primarily in that it is accorded more deference by a reviewing court. See note 74 infra. Thus, as a matter of administrative law, the Administrator found as fact that lead emissions “will endanger” the public health. That in so doing he did not have to rely solely on proved POOR COPY fh Genie 56 ship of that term to other sections of the Clean Air Act. These prescriptions direct the Administrator’s actions. Operating within the prescribed guidelines, he must con- sider all the information available to him. Some of the information will be factual, but much of it will be more speculative—scientific estimates and “guesstimates” of probable harm, hypotheses based on still-developing data, ete. Ultimately he must act, in part on “factual issues,” but largely “on choices of policy, on an assessment of risks, {and} on predictions dealing with matters on the frontiers of scientific knowledge * * *.” Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 181, 501 F.2d at 741. A standard of danger—fear of uncertain or un- known harm—contemplates no more. 3. Propriety of the Cumulative Impact Approach. In addition to demanding that the Administrator act solely on facts, petitioner Ethyl insists that those facts con- vince him that the emission product of the additive to be regulated “in and of itself,” i.e., considered in isolation, endangers health. The Administrator contends that the impact of lead emissions is properly considered together with all other human exposure to lead. See page 18 supra. We agree. First, Ethyl points to the language of Section 202 allowing regulation of any automobile emission that “eauses or contributes to, or is likely to cause or con- scientific fact is inherent in the requirements of legal fact- finding. Petitioners’ assertions of the need to rely on “fact” confuse the two terminologies. We must deal with the termi- nology of law, not science. At law, unless the administrative or judicial task is peculiarly factual in nature, or Congress expressly commands a more rigorous finding, see 21 U.S.C. § 355(d); cf. pages 43-45 supra, assessment of risks as herein described typifies both the administrative and the judicial fact-finding function, and is not the novel or unprecedented theory that petitioners contend. 57 tribute to, air pollution which endangers the public health or welfare.” Section 202(a) (1), 42 U.S.C. § 1857 f-1(a)(1) (emphasis Ethyl’s in its brief at 18). This is contrasted with Section 211’s language allowing regu- lation of fuels or fuel additives whose “emission prod- ucts * * * will endanger the public health or welfare.” By italicizing the “contribute to” language of Section 202 Ethyl presumably suggests that Section 202 is more lenient, allowing use of the cumulative impact theory while Section 211 does not. This argument is but a variant on Ethyl’s already rejected claim that Section 202 allows for regulation of “likely” dangers while Sec- tion 211 does not. As with the earlier argument, this reading of Section 202 must be rejected. While it is possible that Section 202’s inclusion of emissions that “cause or contribute to air pollution” is more encom- passing than Section 211’s term “emission products,” it is clear that whatever leniency Section 202 suggests only concerns the makeup of air pollution. This is irrele- vant to the cumulative impact theory. However they differ, both Section 202 and Section 211 allow regulation of lead additives only on a determination that the re- sultant polluted air, however composed, endangers the public health.* Both provisions leave open the question °° As far as the cumulative impact theory is concerned, the relevant portions of the two provisions are as follows: [The Administrator may regulate any automobile emis- sion that] causes or contributes to, or is likely to cause or contribute to, air pollution which endangers the public health or welfare. Section 202(a)(1), 42 U.S.C. § 1857f-1(a) (1) (emphasis added). [The Administrator may regulate a fuel or fuel additive] if any emission products of such fuel or fuel additive will endanger the public health or welfare * * *. Section 211(c) (1) (A), 42 U.S.C. § 1857f-6c(c) (1) (A) (em- phasis added). Pawo 58 whether emissions or air pollution can be found to en- danger the public health when the endangerment is not caused by that pollution alone.” While Ethyl’s comparison suggests no answer, the ques- tion is directly raised here. The Administrator found endangerment, but recognized that the national lead exposure problem is caused, not by air pollution alone, but by an aggregate of sources, including food, water, leaded paint, and dust. He believed that regulation was justified because the aggregate was dangerous, and be- cause leaded gasoline was a significant source that was particularly suited to ready reduction. 38 FED. REG. 33734. To the question whether the Administrator was correct in his belief, comparison with the “contribute to” language of Section 202 provides no guidance. The only other evidence relied upon by Ethyl for its “in and of itself” theory is a quotation, taken out of context, from Senator Baker. When the context of Ethyl’s partial quotation is revealed the irrelevance of his state- ment to Ethyl’s theory becomes clear. Senator Baker reviewed the Committee bill for the Senate: The [Administrator] is authorized to either control or prohibit the sale of any given fuel when he finds one of two things: First. That the combustion or evaporation of such fuel produces emissions that, in and of them- selves, endanger the public health or welfare; or Second. That such emissions prevent the opera- tion of a system that is necessary to reduce automo- 6° Since automobile emissions generate approximately 90% of all airborne lead, see note 7 supra and accompanying text, the danger posed by lead-polluted air is virtually identical to that posed by lead automobile emissions. As the text suggests, the non-automotive sources of lead with which the cumulative impact theory is concerned are not airborne. ROLIGCGH 59 bile emissions to the levels required by standards issued by the [Administrator] under section 202 of the act. 116 Conc. Rec. 32920 (1970) (emphasis added). Ethyl relies on the Senator’s subsequent repetition of the words “in and of themselves,” italicized above. Ethyl brief at 16. But the second paragraph makes clear that Senator Baker’s meaning is contrary to Ethyl’s implication. He is simply emphasizing the different nature of the two provisions and thus uses the words “in and of them- selves” to show that under Section 211(c)(1)(A) the Administrator may act only because of the direct effects of lead additives on a legislative goal, protection of health, while under Section 211(c) (1) (B) he may act because of their indirect effects on another goal, implementation of emission control systems.” Beyond these two points, Ethyl has nothing more to offer in support of its “in and of itself’ reading. Thus it has made out no case at all, particularly in light of the realities of human exposure to lead and what Con- gress knew about those realities. Such consideration dem- onstrates both that, under Ethyl’s approach, EPA regula- tion of lead on health grounds would be impossible and that Congress could not possibly have intended the re- strictive “by itself’ reading. As has been discussed more extensively above, see pages 10-12 supra, lead enters the human body from multiple sources, so that the effect 61 Ethyl actually quotes Sen. Baker’s second use of the phrase, a few sentences after the one quoted in the text, see 116 Conc. Rec. 32920 (1970). It, however, is in the same context of contrasting permissible EPA action under §§ 211(c) (1) (A) and (B), and thus provides no more sup- port for Ethyl’s position. The implausibility of Ethyl’s read- ing of Sen. Baker’s words is heightened by the fact that the Senator himself realized the important contribution of dietary lead to the total body lead burden and so informed the Senate only sentences before the quoted language. Jd. PHOR CORY 60 of any one source is meaningful only in cumulative terms. If, for example, airborne lead were the only source of the lead body burden, and it caused, by itself, a blood lead level of 30 ug, there would be no danger to the public health. But if that hypothetical 30 ug is added to a possible 30 ug attributable to dietary ingestion, the blood lead level would be 60 ug, a definite threat to health. Under Ethyl’s approach, despite obvious en- dangerment such a cumulative finding is insufficient to justify regulation. Airborne lead, in and of itself, may not be a threat. But the realities of human lead exposure show that no one source in and of itself (except possibly leaded paint) is a threat. Thus, under Ethyl’s tunnel- like reasoning, even if parallel legislation permitted reg- ulation of other sources of lead exposure, which it does not, no regulation could ever be justified. Such cannot be the case. Congress understood that the body lead burden is caused by multiple sources. It un- derstood that determining the effect of lead automobile emissions, by themselves, on human health is of no more practical value than finding the incremental effect on health of the fifteenth sleeping pill swallowed by a would-be suicide.* It did not mean for “endanger” to be measured only in incremental terms.** This the Ad- *2 While the incremental effect of lead emissions on the total body lead burden is of no practical value in determining whether health is endangered, it is of value, of course, in deciding whether the lead exposure problem can fruitfully be attacked through control of lead additives. Moreover, even under the cumulative impact theory emissions must make more than a minimal contribution to total exposure in order to justify regulation under § 211(c) (1) (A). We accept the Administrator’s determination that the contribution must be “significant” before regulation is proper. See 38 FEp. REG. 33734. *? Congress had before it a complete explanation of the multiple sources of human lead exposure. It understood that m~m™ AAP tee 61 ministrator also understood. He determined that absorp- tion of lead automobile emissions, when added to all other human exposure to lead, raises the body lead burden to a level that will endanger health. He realized that lead automobile emissions were, far and away, the most readily reduced significant source of environmental lead. And he determined that the statute authorized him to reduce those emissions on such a finding. We find no error in the Administrator’s use of the cumulative im- pact approach. 4. Summary of the “Will Endanger” Determination. In sum, we must reject petitioners’ cramped and unreal- istic interpretation of Section 211(c) (1) (A). Their read- ing would render the statute largely useless as a basis for health-related regulation of lead emissions. Peti- tioners’ arguments are rebuffed by the plain meaning of the statute and the Administrator’s interpretation of it," by the legislative history and the implications lead is ubiquitous in nature, that trace elements of lead are present in everyone, and that only when lead concentration reaches higher levels would the public be endangered. It could not have thought that lead automobile emissions could, by themselves, endanger the public, although it clearly did think they could be regulated only if they provided a significant increment to the total human lead burden. See, e.g., Hearings on S. 3229, S. 2466 & S. 3546 before the Subcommittee on Air & Water Pollution of the Senate Committee on Public Works, 91st Cong., 2d Sess., pt. 1, at 433-434 (1970) (answers to Sen. Muskie’s questions, supplied by the Dept. of Health, Education & Welfare); id., pt. 3, at 1177; 116 CoNG. REC. 32920 (1970) (remarks of Sen. Baker). *4 Considerable deference is owed to the interpretation of a statute by the officer charged with its administration. Train v. Natural Resources Defense Council, Inc., 421 U.S. 60, 87 (1975) (Clean Air Act); Zuber v. Allen, 396 U.S. 168, 192 (1969); Udall v. Tallman, 380 U.S. 1, 16 (1965); United States v. American Trucking Assns, 310 U.S. 534, 549 (1940). This deference is heightened when, as here, the interpreta- De ee ee ee ee ee a | 62 that can be drawn from other sections of the same statute, by the relevant precedents, and by the estab- lished maxim that health-related legislation is liberally construed to achieve its purpose.” We believe the Administrator may regulate lead ad- ditives under Section 211(c)(1)(A) when he deter- mines, based on his assessment of the risks as developed by consideration of all the information available to him, and as guided by the policy judgment inherent in the statute, that lead automobile emissions significantly in- crease the total human exposure to lead so as to cause a significant risk of harm to the public health. Before so regulating, he must consider the possibility of regula- tion under Section 202." This interpretation of Section tion is of a new statute by its implementing agency. Power Reactor Development Co. v. International Union of Elec- tricians, 367 U.S. 396, 408 (1961); United States v. Zucca, 351 U.S. 91, 96 (1956); United States v. American Trucking Assns, supra; Norwegian Nitrogen Products Co. v. United States, 288 U.S. 294, 315 (1933); Natural Resources Defense Council, Inc. V. Train, 166 U.S.App.D.C. 312, 326, 510 F.2d 692, 706 (1975) (Clean Air Act). See note 16 supra. *5 See, e.g., Parke v. Bradley, 204 Ala. 455, 86 So. 28 (1920); Forbes Vv. Board of Health, 28 Fla. 26, 9 So. 862 (1891); People ex rel. Barmore Vv. Robertson, 302 Ill. 422, 134 N.E. 815, 22 A.L.R. 835 (1922); Blue v. Beach, 155 Ind. 121, 56 N.E. 89 (1900); Walker v. Sears, 245 Iowa 262, 61 N.W.2d 729 (1953); State ex rel. Freeman v. Fadeley, 180 Kan. 652, 308 P.2d 537, 548 (1957); Board of Health v. Kollman, 156 Ky. 351, 160 S.W. 1052 (1913); Rock v. Carney, 21& Mich. 280, 185 N.W. 798, 22 A.L.R. 1178 (1921); State ex rl. Free- man V. Zimmerman, 86 Minn. 358, 90 N.W. 783 (1902); Crayton v. Larabee, 220 N.Y. 493, 116 N.E. 355 (1917); Salt Lake City v. Howe, 37 Utah 170, 106 P. 705 (1910). °° The statute demands “consideration” not only of the rele- vant scientific and medical evidence, but also of the possi- bility of regulation under § 202. Section 211(c) (2) (A), 42 U.S.C. § 1857f-6c(c) (2) (A). That means, of course, no more than it says: actual good faith consideration of the specified BLEED THRC ROUGH 63 211 does not allow for baseless or purposeless regulation, but does grant the Administrator the flexibility needed to confront realistically the public health problem pre- sented by massive diffusion of lead emissions from automobiles. B. Comparison with Substitute Additives Even when the Administrator has determined that a fuel or fuel additive causes emissions which endanger evidence and options, as reflected in the basis and purpose statement required by § 4(b) of the APA, 5 U.S.C. § 553(c). NPRA argues that the statute demands mandatory deference to the possibility of regulation under § 202 rather than mere consideration of such a possibility. NPRA Supp. Br. at 33-35 We reject the argument. NPRA ignores the deletion of the specific findings requirement from the original bill. As pointed out above, see pages 38-43 & note 14 supra, one effect of the deletion was to eliminate mandatory deference to § 202 and substitute instead ‘‘consideration” of § 202 regulation. While Congress thus indicated its preference for regulation under § 202, it left the Administrator with full discretion to im- plement that preference or not. See note 14 supra. NPRA, joined by Nalco, further argues that EPA’s consid- eration of § 202 regulation was arbitrary and capricious be- cause the agency rejected reliance on lead traps as a means of emission control. NPRA Supp. Br. at 35-37; Nalco Supp. Br. at 57-58. EPA did reject lead traps, but that rejection was not arbitrary and capricious. Rather, they were rejected be- cause § 202 authorizes EPA to order emission controls only on new vehicles, which would largely be using lead-free gaso- line anyway because of the catalytic converter. On new ve- hicles there would be no lead emissions to trap. See note 2 supra. The regulations before us seek to reduce lead emissions from in-use vehicles; for such a purpose § 202 is of no use. 38 FED. REG. 33737. We find that EPA’s consideration of the evidence presented and of the alternatives to regulation under § 211 meets the good faith test suggested above. See Citizens to Preserve Overton Park Vv. Volpe, 401 U.S. 402, 416 (1971). See also note 68 infra. POOR COPY 64 the public health, he is not yet free to prohibit the sub- stance under Section 211. He must first find, and pub- lish his finding, that in his judgment such prohibition will not cause the use of any other fuel or fuel additive which will produce emissions which will endanger the pub- lic health or welfare to the same or greater degree than the use of the fuel or fuel additive proposed to be prohibited. Section 211(c) (2)(C), 42 U.S.C. § 1857f-6e(c) (2) (C). Preliminarily it must be noted that the section re- quires a finding only before the Administrator “pro- hibits” a fuel or fuel additive under Section 211. Since the proposed regulations only “control” lead additives, the findings requirement, on its face, does not apply to the EPA action.” If the requirement is read to apply, however, it plainly demands no more than the findings requirement of Section 211(c)(2)(B), as construed in Amoco, see pages 43-44 supra. This conclusion is compelled *? This distinction is not unduly technical, since § 211(c) (1) expressly allows the Administrator to “control or prohibit” while § 211(c) (2) (C), drafted contemporaneously, repeatedly indicates that a finding is required only before a fuel or fuel additive is “prohibited.” Parallel §§ 211(c) (2) (A) and (B), on the other hand, also expressly apply before a fuel or fuel additive may be “controlled or prohibited.” Nonetheless, the purpose behind § 211(c) (2) (C)—avoid- ance of counterproductive results and protection of the public health—suggests that a finding is of equal import whether the fuel or fuel additive is to be controlled or prohibited, so we do not conclude definitely that no such finding is required for control under § 211. Since the Administrator has furn- ished a finding such as is required by § 211(c) (2) (C), 38 FED. REG. 33737-33739 (1973), and we think that finding is adequate under the Amoco standards suggested below, we do not find it necessary to determine whether the finding was required in this case. See note 68 infra. BLEED THROUG 65 by the identical genesis of the two provisions, plus the fact that the Section 211(c) (2) (C) finding is judgmental by its own terms. Thus where the judgment turns “on factual issues” we will “demand sufficient attention to these in the statement to allow the fundamental ra- tionality * * * to be ascertained.” Amoco Oil Co. v. EPA, supra, 163 U.S.App.D.C. at 180-181, 501 F.2d at 740- 741. By contrast, where the judgment is necessarily more speculative, we will “demand adequate reasons and explanations, but not ‘findings’ of the sort familiar from the world of adjudication.” Jd., 163 U.S.App.D.C. at 181, 501 F.2d at 741.° ** Naleo argues that the Adiministrator’s recent decision to suspend the 1977 statutory emission standards for hydro- carbons and carbonmonoxide, 40 FED. REG. 11900, see note 2 supra, invalidates his assessment of the impact of the substi- tute additive, aromatic hydrocarbons. Nalco Supp. Br. at 45- 50. Cf. NPRA Supp. Br. at 48-49. This argument appears to be a challenge to the regulations based on new information. Such challenges are cognizable under § 307 of the Clean Air Act, 42 U.S.C. § 1857h-5(b) (1), but may be brought to this court only after a preliminary presentment of the new infor- mation and a request for action to the agency. Oljato Chap- ter of Navajo Tribe Vv. Train, U.S.App.D.C. . - , 515 F.2d 654, 666-667 (1975). Since Nalco has not com- plied with the rule of Oljato Chapter, this new information claim does not appear to be properly before us. In any case, however, Nalco’s claim is without merit. Un- doubtedly high octane aromatic hydrocarbons will be used to compensate for the reduction in lead caused by the regula- tions and the average aromatic content of gasoline will rise from 22‘7 to 29° (this increase includes that attributable to the lead-free regulations at issue in Amoco). Aromatics can result in emissions of polynuclear aromatic (PNA) hydro- carbons, some of which are carcinogenic. Nonetheless, the Administrator determined that substitution of PNA emissions for lead emissions would be less dangerous to the public health because: (1) PNA emissions from auto- mobiles, together with emissions from refineries that produce gasoline, account for only approximately 2% of PNA emis- POOR COPY ea St Le evati sek oe Y. | 66 After making the “will endanger” determination and the “substitute additives” finding, EPA has complied with the statutory mandate and is free to regulate the fuel or fuel additive under Section 211. Ill. THE EVIDENCE A. The Standard of Review In promulgating the low-lead regulations under Section 211, EPA engaged in informal rule-making. As such, since the statute does not indicate otherwise, its proce- sions in the ambient air: (2) PNA emissions are being re- duced from automobiles by the applicable hydrocarbon stand- ards; and (3) PNA automobile emissions will continue to decrease overall, even while the hydrocarbon content of gaso- line increases, as uncontrolled automobiles are retired and replaced by those with emission control systems. 38 FED. REG. 33738. Thus the Administrator concluded that replace- ment of lead additives by increased hydrocarbons would re- sult only in a slight slowing of the rate of decrease of PNA emissions from automobiles. We think this is a sufficient find- ing under § 211(c) (2) (C). Nalco’s charge that suspension of emission standards changes this calculation is untrue. Even under the suspended standards, hydrocarbons will be significantly controlled and PNA emissions will continue to decrease. EPA calculated the effect of an increase in hydrocarbon content of gasoline under several anticipated circumstances, including the as- sumption that the interim standards would remain in effect through 1980. In that circumstance, which may turn out to be the correct forecast, PNA emissions would still decrease 69°7 over 1973 levels by 1980. Without the low-lead regula- tions they would decrease 72°, only a 3% better rate. JA 1428-1431; see also id. 1489-1490. Thus EPA anticipated the possibility of suspended emission standards, calculated the effects of that suspension on PNA emissions, and found them to be minimal. We cannot find this substitute additive finding to be insufficient. BLEED THRO GH 67 dures are conducted pursuant to Section 4 of the APA,” 5 U.S.C. £553, and must be reviewed under Section 10 of the Act,” 5 U.S.C. § 706(2)(A)-(D). Our review of the evidence is governed by Section 10(e) (2) (A), which requires us to strike “agency action, findings, and con- clusions” that we find to be “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law * * *.”" 5 US.C. § 706(2)(A). This standard of * The hybrid procedures that placed the EPA action some- where between informal rule-making and adjudication and that caused such extended inquiry by the Amoco court are largely absent from this case. In Amoco, in addition to the “findings” requirement of § 211(c) (2) (B), the court had to deal with the same section’s requirement of a public hearing. The resultant standard of review was, nonetheless, not sig- nificantly different from traditional “arbitrary and capri- cious” review. See Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App.D.C. at 171-181, 501 F.2d at 731-741. In this case there is no public hearing requirement and the only “find- ings” requirement is that of § 211(c) (2) (C), which we have construed at pp. 63-66 supra. The requirement that the Administrator “consider” vari- ous evidence before acting under § 211(c)(1)(A) guides the direction, but does not affect the rigor, of “arbitrary and capricious” review. Such guidelines are typical as a prerequi- site for agency action, se, ¢.g., § 1002(e) (the Rule of Rate- making) of the Federal Aviation Act of 1958, 49 U.S.C. § 1482(e) (1970), and assurance of agency compliance is sim- ply one part of “arbitrary and capricious” review. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971) (court must determine “whether the decision was based on a consideration of the relevant factors”). * All the Clean Air Act says about judicial review of EPA action under $211 is that it shall be available exclusively in this court. 42 U.S.C. § 1857h-5(b) (1). “Our review of the Administrator’s construction of the statute, see pages 16-66 supra, is authorized by § 10(e) (2) (C), 5 U.S.C. § 706(2) (C), which allows the reviewing court to set aside agency action it finds to be “in excess of statutory jurisdiction, authority, or limitations, or short of statutory POOR COPY 68 review is a highly deferential one. It presumes agency action to be valid. Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 415 (1971); Pacific States Box & Basket Co. v. White, 296 U.S. 176, 185-186 (1935) ; United States v. Chemica! Foundation, 272 U.S. 1, 14- 15 (1926). Moreover, it forbids the court’s substi- tuting its judgment for that of the agency, Citizens to Preserve Overton Park v. Volpe, supra, 401 USS. at 416, and requires affirmance if a rational basis exists for the agency’s decision.** Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., 419 U.S. 281, 290 (1974). Cf. United States v. Allegheny-Ludlum Steel Corp., 406 U.S. 742, 749 (1972). This is not to say, however, that we must rubber- stamp the agency decision as correct. To do so would render the appellate process a superfluous (although time- consuming) ritual. Rather, the reviewing court must assure itself that the agency decision was “based on right * * *.” Our review of EPA procedures, sec pages 97- 111 infra, is pursuant to § 10(e) (2) (D), 5 U.S.C. § 706(2) (D), which authorizes reversal of agency action taken “with- out observance of procedure required by law.” 7? NPRA seeks to attach meaning to the fact that an ex- press presumption of validity was included in the Senate ver- sion of the Clean Air Act, and then deleted by the conference committee. NPRA Supp. Br. at 21-24. See S. Rep. No. 91- 1196, 91st Cong., 2d Sess. at 41, 125 (1970). As the above cited cases make clear, however, a general presumption of validity attaches to any regulation within an agency’s dele- gated powers. Thus the deletion is of no consequence. ** Of course, that basis must be expressed by the agency itself and not supplied by the court. SEC v. Chenery Corp., 332 U.S. 194, 196 (1947). Nonetheless, a decision of “less than ideal clarity” will be upheld if the agency’s rationale “may reasonably be discerned.” Bowman Transportation, Ine. V. Arkansas-Best Freight System, Inc., 419 U.S. 281, 286 (1974). See also Colorado Interstate Gas Co. v. FPC, 324 U.S. 581, 595 (1945). BLEED THR OUGH 69 consideration of the relevant factors * * *.”** More- ** Overton Park also requires the reviewing court to con- sider “whether there has been a clear error of judgment.” Citizens to Preserve Overton Park v. Volpe, supra note 69, 401 U.S. at 416, citing L. JAFFE, JUDICIAL CONTROL OF AD- MINISTRATIVE ACTION 182 (1965) ; McBee v. Bomar, 296 F.2d 235, 237 (6th Cir. 1961) ; Jn re Josephson, 218 F.2d 174, 182 (1st Cir. 1954); Western Addition Community Organization Vv. Weaver, 294 F.Supp. 433 (N.D. Cal. 1968); Wong Wing Hang v. INS, 360 F.2d 715, 719, (2d Cir. 1966). While as used, carefully bracketed by traditional statements of the restraint of “arbitrary and capricious” review, the phrase works no change in the law, the Court’s choice of language is troublesome. The phrase sounds much like the “clearly er- roneous” standard used to review the factual findings of a trial court sitting without a jury. Rule 52(a), FED. R. Civ. P. Unlike an agency determination or a jury verdict, such find- ings may be fairly readily reversed. District of Columbia V. Pace, 320 U.S. 698, 702 (1944); 4 K. DAVIs, supra note 15, § 29.02, at 118-126; L. JAFFE, supra, at 615-616. See espe- cially Orvis v. Higgins, 180 F.2d 537, 540 (2d Cir.) (Frank, J.), cert. denied, 340 U.S. 810 (1950). Indeed, under “clearly erroneous” review a court may substitute its judgment for that of the trial court and upset findings that are not unrea- sonable. Sce 4 K. DAVIS, supra note 15, at 121-122. Since Overton Park expressly forbade such intrusive re- view, 401 U.S. at 416, it plainly did not intend to use the “clear error of judgment” phrase to replace swb_ silentio “arbitrary and capricious” review with “clearly erroneous” review. Nonetheless, more than linguistic echoes of “clearly erroneous” review accompany the Court’s turn of phrase. To the extent the cases relied upon by the Court support consid- eration of “clear errors of judgment,” they all involve review of trial courts’, and not agencies’, abuses of discretion. See cases cited supra, and compare L. JAFFE, supra, at 182 with id. at 615-616. Such review is intrusive and essentially iden- tical with “clearly erroneous” review. See McBee v. Bomar, supra; In re Josephson, supra. On the other hand, the Court also cited a case in which Judge Friendly recognized that an agency’s abuse of discretion, unlike a court’s, is reviewed under the “arbitrary and capricious” standard, 5 U.S.C. § 706(2) (A), and that review in such cases should be much POOR COPY 1) eee lle a Kor ARR a 68 PLN a p45 BY 08, ANN Ba EMI ri MR e's SNR eM IR ENG hal ag tia 6 ‘oes: Se ane aE OC ee we ere ee " M ns 70 over, it must engage in a “substantial inquiry” into the facts, one that is “searching and careful.” Citizens to Preserve Overton Park v. Volpe, supra, 401 U.S. at 415, more deferential than under the “clearly erroneous” stand- ard. Wong Wing Hang Vv. INS, supra, 360 F.2d at 718-719. All of this makes the Court’s intent in Overton Park some- what difficult to plumb and its standard even more uncertain of application. We do not think the Court’s use of the “clear error of judgment” phrase was an attempt vastly to revamp traditional “arbitrary and capricious” review. See infra. Nonetheless, we fear, its use of this phrase so familiar to judges in another, and significantly more intrusive, context may unintentionally prompt judicial distortion of the “arbi- trary and capricious” standard. Already at least one court has expressly indicated that it is prepared to read the Court’s use of the phrase as approval! of intrusive “clearly erroneous” review of agency action. Raitport v. National Bureau of Standards, 385 F.Supp. 1221, 1225 (E.D. Pa. 1974). Mean- while, other courts use the “clear error of judgment” phrase as a shorthand summary of “arbitrary and capricious” re- view, see, e.g., Union Electric Co. v. EPA, 515 F.2d 206, 216 (8th Cir.), cert. granted, U.S. , 44 U.S. L. WEEK 3200 (Oct. 6, 1975) ; Conservation Council of North Carolina V. Froehlke, 473 F.2d 664, 665 (4th Cir. 1973); Schicke v. United States, 346 F.Supp. 417, 420, 422-423 (D. Conn. 1972), while others loosely treat the phrase as synonymous with “clearly erroneous.” Duke City Lumber Co. v. Butz, 382 F.Supp. 362, 374 (D.D.C. 1974) (‘whether the agency’s threshold decision was arbitrary, capricious or otherwise clearly erroneous”); Daly v. Volpe, 350 F.Supp. 252, 255 (W.D. Wash. 1972) (“it was not clearly erroneous, and there- fore it was not arbitrary and capricious”). Post-Overton Park decisions, as well as the internal evi- dence in Overton Park itself, see swpra, have made clear that the Court does not intend the “clear error of judgment” phrase to sanction review more intrusive than traditional “arbitrary and capricious” review; rather, the Court has reaffirmed that the reviewing court must defer if the agency has a rational basis for its decision. Bowman Transportation, Ine. V. Arkansas-Best Freight System, Inc., supra note 73, 419 U.S. at 290; United States v. Allegheny-Ludlum Steel Corp., 406 U.S. 742, 749 (1972). See note 79 infra. Thus it te BLEED THRC ? *. Hearings on S. 3229, S. 3455, S. 3546 before the Subcomm. on Air and Water Pollution of the Senate Comm. on Public Works, 91st Cong., 2d Sess. at 74 (1970). No less than with “particularly sensitive citizens such as bronchial asthmatics and emphysematics” who receive the special attention of the Clean Air Act, S. Rep. No. 91-1196, 91st Cong., 2d Sess. 10 (1970), citizens who are occupationally exposed outdoors to otherwise uncontrollable lead concentrations in the ambient air are among “the most vulnerable in our population” and deserve to be considered when regulations under § 211(c) (1) (A) are at issue. 83 group of research subjects. See D. CLARK & B. MAC- MAHON, PREVENTIVE MEDICINE 26 (1967) (hereinafter CLakK & MACMAHON). Thus much of the evidence in Reserve Mining of the danger to the general public of absorption of asbestos particles came from epidemio- logical studies of asbestos workers. Reserve Mining Co. v. EPA, supra, 514 F.2d at 507.” Because of this the occupational data are not only in themselves indicative of high blood lead levels among a significant portion of the adult population, but they suggest the future likeli- hood, absent controls, of increasing high blood lead levels among even more widely dispersed portions of the public. In any case, however, the evidence relied upon by the Administrator was not only of occupational groups. Some evidence of high blood lead level relates to such “spec- cialized” groups as “Drivers of Cars.” “Male Com- muters,” and “Urban” residents. Third Health Docu- ment at Tables VII-1 & 2, JA 145-146. Petitioners argue that the negative conclusions of the Seven Cities Study and several other studies should “ The dissent criticizes this comparison of the Adminis- trator’s use of studies of occupational groups with the Eighth Circuit’s use of similar evidence on the ground that the court explained the validity of its use of occupational data whereas the Administrator did not. Dissent at 73. The Administra- tor, however, based his inferences on studies of occupational groups whose lead intake results from exposure, albeit for longer than average periods of time, to the same air breathed by the general public. See pp. 81-82 supra. The Eighth Circuit, by contrast, was explaining the validity of inferring a haz- ard to the general public from studies showing a hazard to workers and others exposed to higher levels of a some- what different substance than that with which the court was concerned. See 514 F.2d at 511-512. In short, the Eighth Circuit was faced with a situation where differences between the hazard facing the eccupationally exposed group and the hazard facing the general public required that the propriety of reaching a conclusion about the public from occupational studies be explained; the Administrator was not. wee, Ge ONE OTR DRE” ea one A 84 outweigh the positive indications of the studies described above. PPG/duPont Supp. Br. at 16-23; NPRA Supp. Br. at 5-8. The Administrator disagreed, and we can- not fault his conclusion. Because of the many uncon- trolled variables in epidemiological studies, valid con- clusions may be obscured. But, while the possibility of false negative conclusions is a real one, the possibility of false positive findings is considerably less likely. CLARK & MACMAHON, supra, at 100. Thus the Ad- ministrator credited the occupational and other studies reporting a small, but significant, portion of the general population with elevated blood lead levels and discounted the negative studies on which petitioners rely. Third Health Document at VII-3, JA 144. We cannot say his conclusion was arbitrary or capricious. 2. Automobile Lead Emission Products Are Directly Absorbed in the Body to a Significant Extent Since it is apparent from the face of his decision and the Third Health Document that the Administrator con- sidered all the evidence before him, the only issue is whether he treated that evidence in a rational manner. Petitioners have now conceded that lead emissions are directly absorbed in the body from the ambient air, and they challenge only whether the extent of absorption is significant enough to justify these regulations. Nalco Supp. Br. at 37; PPG/duPont Supp. Br. at 23. The Administrator’s conclusion that lead absorption from the air is significant is amply supported by the record in this rule-making. The Administrator relied on three types of evidence: theoretical, epidemiological, and clinical studies. The theo- retical evidence consisted of a set of calculations de- signed to estimate the amount of lead in the air which, when added to an average dietary intake, would suffice to bring the blood lead burden of a “standard man” up orirercnrn hI) ‘eat fi 85 to 40 ug.”’ These calculations indicated that the 40 ug level can be reached by exposure to ambient air lead concentrations no greater than those now found in parts of our larger cities. Significantly, the results of two clinical experiments support the estimates derived from these theoretical calculations. The calculations, as well as petitioners’ misguided attacks on their validity, are discussed in Appendix A to this opinion. See pages A-1 to A-4 infra. The second type of evidence relied upon by the Ad- ministrator in reaching his conclusion that airborne lead contributes significantly to the human lead body burden consisted of epidemiological research. Epidemiologists study the effects of various phenomena on humans under uncontrolled or “natural” conditions. These effects are correlated with other observed facts in an attempt to develop significant relationships among the data. The science is limited, however, in that inferences may be drawn, but relationships cannot be proved by the cor- relations alone. JA 583. The studies before the Ad- ministrator were of large groups of people; correlations were sought between blood lead level and exposure to lead in the ambient air. The studies were confounded, however, by the multiple sources of lead. Since diet accounts for a major portion of the body lead burden, an individual’s blood lead level varies not only accord- ing to his exposure to lead in the ambient air, but ac- cording to his daily dietary intake of lead. Wide varia- tions in dietary lead intake, which are common, can completely mask the effects of air lead absorption. None- theless, none of the epidemiological studies could control or measure dietary lead intake. This uncertainty in the data severely limited the usefulness of the broadly con- “ EPA specifically requested comment on the figures it used in calculating the respiratory absorption of lead by a “standard man.” 37 FED. REG. 11787 (1972), JA 21. omAmMmnD fm Dpyv TS RO Ge ee ae | ai caiiet anes SABE AS nadctiaae ies 86 ceived epidemiological studies and led the Administra- tor to rely instead on data limited to situations in which dietary exposure could roughly be termed constant. Following this rationale, the Administrator focused on the consistent relationship found between air and blood lead levels within particular metropolitan areas, rather than on the lack of such a relationship between areas.” See pages A-5 to A-9 infra. The Administrator “ The dissent suggests that this court, not the Administra- tor, first propounded this rationale for relying on the intra- metropolitan results of the epidemiological studies. Dissent at 76-77. This critique ignores the facts that the Administra- tor referred to this explanation at the beginning of his opin- ion, JA 3, and that the Third Health Document identifies the language in the Seven Cities Study which justifies the Ad- ministrator’s reliance on that study’s intrametropolitan area data. JA 89, quoting JA 844 (the introductory summary of the Seven Cities Study). The section of the Seven Cities Study summarized by the language quoted in the Third Health Document explicitly states the rationale relied on by the Administrator. JA 892; see pp. A-5 to A-6 & note 4 infra. Clearly, the “agency’s path” to its decision to credit the intrametropolitan results “may reasonably be discerned.” Bowman Transportation, Inc. v. Arkansas-Best Freight Sys- tem, Inc., supra note 73, 419 U.S. at 286. Despite its origins in the Seven Cities Study itself, the dis- sent rejects this explanation for the Administrator’s ap- proach to the evidence as totally irrational. The dissent ar- gues that it is illogical to maintain that intrametropolitan dietary lead can be assumed to be relatively constant despite the income differences in a large metropolitan area. This argument, which has no foundation in any material before this court, illustrates the danger of “plausible-sounding, but simplistic, judgments of the relative weight to be afforded various pieces of technical data.” Concurring op. of Chief Judge Bazelon at 2. Without ourselves attempting to assume a scientific role, we note that since the main source of dietary lead is the soil, see note 5 supra, the geographical origin of foodstuffs may be a more important determinant of their lead content than is price. In any event, whatever the underlying BLEED 4ROUGH 87 also drew support for his conclusion that lead in the air significantly affects lead in the blood from studies conducted in single neighborhoods. There, too, confound- ing factors were minimized by proximity, and there, too, a clear direct relationship was found. See pages A- 11 to A-14 infra. Thus the epidemiological studies, although perhaps insufficient to justify the Administra- tor’s decision if considered singly or even collectively, were reasonably relied on as part of the basis for the low-lead rules. The conclusions the Administrator drew from theo- retical calculations and the epidemiological studies are significantly bolstered by two important clinical studies. Clinical studies are laboratory experiments on humans in which variables can be controlled and causal relation- ships demonstrated. Clinicians attempt to reproduce at- mospheric conditions in the laboratory and measure the response to pollution of small numbers of humans chosen to represent the population at large. JA 583. Because of its necessarily significant intrusion on the subjects’ lives, clinical research is limited in the number of sub- jects it can study. Nonetheless, the two clinical studies are especially valuable since they are the only attempts to control or account for dietary lead intake. Thus they sought to measure the contribution of respiratory ab- sorption of lead unmasked by variations in dietary lead. Both studies found that airborne lead provided a significant portion of the lead in the blood of the experiments’ subjects. Moreover, the amount of lead actually absorbed from the air during these studies cor- responded ciosely with the amount EPA’s theoretical cal- culations predicted would be absorbed. See pages A-14 to A-18 infra. basis for this approach might be, the important point is that we have no reason to fault the Administrator’s decision to rely on the scientific expertise of the authors of the epidemiol- ogical studies before him. POOR COPY 88 While we must consider petitioners’ arguments care- fully, the necessary existence of limitations and incon- sistencies in the data remind us to observe carefully ; our limited appellate function. It does not matter : whether or not we agree with the Administrator’s de- 3 termination. Nor does it matter whether the evidence : might support a conclusion contrary to that reached by the Administrator. All that is of concern to us is that there be a rational basis in the evidence for the con- clusion reached. We cannot say there is not. The bulk of the evidence cited supports the Administrator. See Appendix A to this opinion. The Administrator treated all the evidence in a consistent and rational manner. This treatment disposed of most of the studies relied upon by petitioners, leaving the plain conclusion that lead emissions form a significant part of the human body burden. Particularly in light of the precautionary nature of the “will endanger” standard, we cannot find the Administrator’s conclusion to be arbitrary or ca- pricious. Accordingly, we must uphold his determination. ates 3. Lead Exposure from Dustfall Threatens the Health of Children : While we would have no difficulty in sustaining the : low-lead regulations solely on the basis of the evidence and conclusions discussed above, the Administrator based his decision to regulate on other evidence as well. He presented a hypothesis, which he found consistent with known information, that urban children are particularly threatened by lead additives in that they are prone to ingest lead emissions that have fallen to the ground and mixed with dust. While the hyopthesis is admittedly not proved as fact, we need not decide whether it would be sufficient by itself to support the low-lead regulations, for it is offered only in support of the evidence already presented. Petitioners vigorously attack the hypothesis nonetheless, but constantly confuse the issue by ignoring ee ee eae ian sine manele PIPES IAAT IR MG BIAS SFR EATS LI PION SE BLEED THROUG 89 the flexibility of the “will endanger” standard and by attempting to refute the Administrator with evidence that he both understands and has accounted for. Thus it is helpful first to set these matters straight. First, as we have demonstrated above, see pages 17- 36 supra, the “will endanger” standard is a precau- tionary standard that embraces a wide range of per- missible proof. It is therefore no objection to the dust- fall hypothesis that it is merely a hypothesis. A sup- portable and reasonable hypothesis may well form the basis for regulations under Section 211(c)(1)(A). In- deed, the totality of evidence relied upon in the Re- serve Mining case constituted no more than such a hypothesis. See pages 93-94 infra. Second, although it seems too obvious to mention, the Administrator understood and expressly recognized that leaded paint “is the primary cause of clinical lead poisoning” in children, 38 FED. REG. 33735. Although petitioners repeatedly try to rebut EPA conclusions by stating this fact, the Administrator was well aware of it and his evaluation of the data before him invariably accounted for it. We do not believe the importance of lead paint to the lead poisoning problem in children invalidates the Administrator’s reliance on the dustfall theory. The Administrator justified his hypothesis as a basis for regulation on grounds that dustfall may be regulated far more readily than leaded paint, that dust- fall contributes significantly to the threat from leaded paint by raising blood lead levels so as to make lead poisoning easier to contract, and that even when acute lead poisoning does not develop absorption of lead dust- fall may cause undesirable and avoidable subclinical effects. 388 FED. REG. 33736-33737. We have held, see *’ Petitioners’ persistent refusal to recognize that these are the reasons the Administrator is concerned about lead dust- fall makes their constant arguments about leaded paints com- IROUGH POOR COPY alae haiti oatte tak oo DE a cs “ SO AIA PCE PRR RT -- — peels SL ce rata, Uae acre ante Rney Sa A, ee ser ee OES CE EUAN rd AAO has EN 90 pages 56-61 supra, that concern about the cumulative impact of exposure to various lead sources may justify regulation of lead additives under Section 211(c) (1) (A). Thus we cannot say that these reasons for regulation, when added to the demonstrated danger to the general public from respiratory absorption of lead emissions, see Appendix A to this opinion, and if supported by the evidence, do not form a permissible basis for the low- lead regulations under the “will endanger” standard. With these preliminaries settled, we turn to the evi- dence supporting the Administrator’s determination. Since the hypothesis is only a secondary basis for the regulations, and since the evidence cited goes consider- ably beyond that necessary to establish the hypothesis as reasonable, we shall address only the thrust of pe- titioners’ objections and the Administrator’s responses. The logical steps to the Administrator’s conclusion are these: a. High lead concentrations in dust and dirt are prevalent in urban areas. b. In most circumstances, lead from exhausts and not lead paint or lead from stationary sources is the primary source of lead in urban dust and dirt. e. Children prone to pica, about 50 percent of those between the ages of one and three, eat non- food objects, including dust and dirt. d. As a result of ingesting dust and dirt con- taminated with lead fallout, children can be expected to absorb lead into their bodies. 38 FED. REG. 33736. If the intermediate steps are supported by the evidence, the validity of the Adminis- trator’s conclusion as a reasonable hypothesis is un- assailable. Our study of the underlying evidence con- pletely unresponsive to the Administrator’s analysis of the evidence. BLEED THR¢ 91 vinces us that it is firm and convincing, and certainly sufficient to support the Administrator’s hypothesis as reasonable. Petitioners concede that lead concentrations are high in the dust near highways and adjacent to homes with lead paint. They contest, however, that high lead concen- trations are otherwise prevalent in urban areas. PPG/ duPont Supp. Br. at 37 n.86. The facts rebut their argu- ment. The NAS Panel found that “[t]he concentration of lead in street dust and surface soil of large cities is extremely high.” NAS Report at 30 (emphasis added). This conclusion was based on a finding that, compared to the usual range of dust lead concentrations of 2-200 parts per million (ppm), dust lead concentrations in cities averaged 1,636 ppm and 2,413 ppm respectively for residential and commercial sites. Even in city parks lead concentrations ranged from 194 ppm to 3,357 ppm. Jd. Other evidence of record shows high lead concentrations in Central Park Zoo in New York City, JA 2630, and school playgrounds in Philadelphia, JA 674. Where does this high dust lead content come from? The Administrator concluded that since 90 percent of the lead in the ambient air is from automotive exhausts and since, as petitioners concede, PPG/duPont Reply Br. at 17, the lead eventually settles to the ground, most of the lead in dust is a product of automobile lead emissions. Petitioners do not seriously contest this; indeed their own studies suggest this by showing that lead content in soil decreases with distance from highways.** Rather, they argue that “lead from paint or stationary sources is the source of lead in dust and dirt in areas where young children play.” PPG/duPont Supp. Br. at 37 n.86. “*Ter Haar & Aronow, New Information on Lead in Dirt and Dust as Related to the Childhood Lead Problem, presented at the EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N.C., Oct. 1, 1973, JA 917, 922 (Fig. 1). ‘OUGH POOR COPY 7s AN tre nitRcata he a Ee en et ee winds Bia ves captag ith He ue), WO HUD legit Sales Sari wea ADE tae i CANE es a tomes tac | ae ae on 2 4 92 This argument reflects petitioners’ consistent refusal to recognize that city children play regularly in city streets, where petitioners concede lead dustfall from automobiles accumulates. PPG/duPont Reply Br. at 17. Since the Administrator’s concern about dustfall is based on the harm it may cause city children, petitioners’ argument that children are not exposed to automobile dustfall where they play must be rejected. Petitioners do not contest that pica is a common phe- nomenon among preschool children, although they note that it “is a psychological disorder; it is not characteris- tic of all children * * *.” PPG/duPont Supp. Br. at 37 n.86. While this is certainly true, pica is characteristic of a significant number of children. Petitioners do not challenge the conclusion of the NAS Panel that pica oc- curs in at least 50 percent of both middle- and lower- class children. NAS Report at 133. On the basis of this evidence alone it is reasonable to hypothesize that children with pica will ingest dust and dirt containing lead dustfall from automobiles. Indeed, on such limited evidence the NAS Panel accepted the dustfall hypothesis as credible: Airborne lead wastes from such sources as auto- mobile emissions and the weathering and demolition of old buildings can be expected to have a signifi- cant additive effect on the total intake. This would be sufficient to evoke compensatory metabolic re- sponses that are now considered subclinical (such as increased urinary ALA), at the very least. It may be estimated that dustfall from airborne lead, if swallowed, can make a significant contribution to a small child’s total lead intake and thereby con- tribute to the occurrence of lead poisoning, espe- cially in urban areas. Even so, the direct ingestion of lead-pigment paints is clearly the principal en- vironmental source in cases of severe acute lead poisoning in young children. 93 NAS Report at 140 (emphasis added). Again petition- ers focus on the last sentence and emphasize the danger from leaded paints. Since the Administrator is in agree- ment with them on the point, howeyer, their arguments are superfluous. 4 Petitioners’ primary claims are not addressed to the evidence that establishes the dustfall hypothesis as ten- able. Rather, they argue that there is no evidence that lead dustfall from automobiles is in fact swallowed by children with pica. While such proof is not necessary to establish the Administrator’s hypothesis as reasonable, see pages 90-91 supra, we note that a considerable amount of circumstantial evidence does support his con- clusion. See Appendix B to this opinion. In any case, all the evidence suggesting that the chil- dren with pica tend to eat dust contaminated with lead fallout from automobiles takes the Administrator’s theory far beyond the hypothesis stage. He offered only a tenta- tive result, “a hypothesis consistent with information pro- vided by a variety of studies.” 38 FED. REG. 33736. Un- doubtedly, he has shown that. Indeed, as reasonable med- ical hypotheses go, this one is particularly solid. This is vividly demonstrated by recalling the kind of evidence relied upon to justify similar precautionary relief in Reserve Mining. The question in that case was the validity of the hy- pothesis that ingestion of asbestos fibers was dangerous to health. The reason for concern was that epidemiolog- ical studies had associated inhalation of asbestos with cancer. The evidence supporting the hypothesis was of three kinds: (1) a court-sponsored study to determine whether asbestos fibers were present in residents who drank the polluted water; (2) animal studies designed to measure whether asbestos fibers can be absorbed into the body from the stomach; and (3) epidemiological studies associating inhalation of asbestos fibers with gas- trointestinal cancer and the theory that this may be due - elicitin | 94 to ingestion of asbestos fibers initially inhaled. Reserve Mining Co. v. EPA, supra, 514 F.2d at 514. Upon re- view of the evidence the court concluded (1) asbestos fibers were not present in long-time residents; (2) the animal studies were ambiguous on whether asbestos fibers could be absorbed if ingested; and (3) the theory that asbestos workers ingested asbestos fibers as well as in- haled them was no more than a theory, id. at 514-516. Nonetheless, solely on the basis of this evidence, the court concluded that “the theory that excess cancers may be attributed to the ingestion of asbestos fibers rests on a tenable medical hypothesis,” id. at 516. On the basis of this tenable hypothesis, the court accepted the further hypothesis that asbestos could be ingested from the drinking water and that, therefore, there was a “rea- sonable medical concern” for the public health which justified abatement of the asbestos discharge under the “endangering” language of the FWPCA. /d. at 520. None of these uncertainties cloud the Administrator’s dustfall hypothesis. Lead is present in children, and in elevated amounts. Children do ingest dust, and dust is heavily laden with lead. Animal studies prove that in- gested lead dust is absorbed into the bloodstream. And epidemiological studies associate high lead concentrations in children with high lead concentrations in dirt and dust, and with proximity to automobiles. Since the auto- mobile is the predominant source of lead in dust, the Administrator’s hypothesis stands firm as reasonable, un- doubtedly with more support in studies already made than the hypothesis that justified regulation in Reserve Mining. Indeed, the primary difference between this case and Reserve Mining is that the Eighth Circuit justified ordering abatement of asbestos discharges into the water solely on the basis of a hypothesis,” while here the hy- ee aT Se A aetna ery Maen ** Since proof of the danger posed by inhalation of asbestos wastes was much stronger than proof of the danger posed by ODE SELON U RT ot A OT Be MAD ae CIE ni nial Aes DI SU A te Ag ie ry Weide Danes nor»rircrcn i rhIp ri GH 95 pothesis is offered only as support for the regulations, the primary basis being the demonstrated danger to health posed by inhalation of lead emissions. In this con- text, and keeping in mind the precautionary nature of the “will endanger” standard, we have no difficulty in finding the dustfall hypothesis sufficiently well grounded to support the Administrator’s limited reliance on it.” C. Summary of the Evidence From a vast mass of evidence the Administrator has concluded that the emission products of lead addi- tives will endanger the public health. He has handled an extraordinarily complicated problem with great care and candor. The evidence did not necessarily always point in one direction and frequently, until] EPA authorized research, there was no evidence at all.” The Adminis- ingestion, the Reserve Mining court ordered immediate ac- tion taken with regard to the discharge of wastes into the air. Sce note 34 supra. % The dissent states that its disagreement with the Admin- istrator and the majority concerning the interpretation of the “will endanger” standard “reduces itself to semantics.” Dis- sent at 4. The dissent also rejects the Administrator’s reli- ance on the dustfall hypothesis simply because it is a hy- pothesis. Dissent at 84-85. Yet as we have demonstrated above and as the Reserve Mining court held, a reasonable hypothesis supported by evidence is a sufficient basis for regulating under the “will endanger” standard as the Administrator has interpreted that standard. * This fact completely rebuts petitioners’ claim that this case does not present problems “on the frontiers of scientific knowledge.” Industrial Union Department, AFL-CIO V. Hodgson, supra note 35, 162 U.S.App.D.C. at 338, 499 F.2d at 474. See, e.g., NPRA Supp. Br. at 49. Although petitioners note that lead additives have been in use for over 50 years, and that questions about their safety have been raised for al- most as long, see note 3 supra, the fact remains that virtually all the evidence cited by both EPA and petitioners was de- POOR COPY 96 trator reached his conclusion only after hearings spread over several months, consideration of thousands of pages of documents, publication of three health documents, three formal comment periods, and receipt of hundreds i of comments. Each study was considered independently ; its worth was assessed only after it was measured against any critical comments. From the totality of the evidence the Administrator concluded that regulation under Sec- tion 211(c) (1) (A) was warranted." : veloped in the last five years, most of it for the purpose of sup- 3 porting or opposing these regulations. Cf. note 3 supra. Moreover, both EPA and petitioners admit much more re- : mains to be discovered. See pp. 48-49 and note 83 supra. ** The dissent’s repeated assertion that the evidence was in- sufficient to convince the independent scientific community, 7 represented by other Government agencies, is unconvincing for two reasons. First, the Department of Health, Education, and Welfare, which shares with EPA responsibility for and : scientific expertise in the areas of public and environmental health, endorsed the regulations. The dissent relies on a Jan. 29, 1973 letter from then Secretary of HEW Elliot Richard- son to demonstrate the Department’s opposition to the lead reduction regulations. Dissent at 14. The Aug. 7, 1973 letter : of Richardson’s successor, Caspar Weinberger, in which the ; Department endorsed removing lead from gasoline provided § the result would not be the introduction of more harmful ; additives, JA 2507, is unconvincingly discounted. Dissent at 13-14 n.27. We have found reasonable the Administrator’s 3 determination that reducing the lead content of gasoline would j not have this perverse effect on the public health. See pp. 64-66 : & notes 67-68 supra. 4 Second, the dissent’s equation of the views of other Govern- 4 ment agencies with the views of the independent scientific : community is itself fallacious. Without in the least impugning their motivation, it may be assumed that agencies such as ’ the Department of the Interior and the Department of Com- merce, see dissent at 9, 14, respond to and represent interests : other than those concerned with the environment and the 4 public health. The very existence of EPA is evidence that ‘ Congress believed the other agencies of the Government could : . — _ FREESE ARSE A a SIT RR NOL PLL RAE PERI NOS é es Fe GG TLE PMS GOEL REPLY PE GTS PIER * , " BLEED THROU‘! - 97 In tracking his path through the evidence we, in our appellate role, have also considered separately each study and the objections petitioners make thereto. In no case have we found the Administrator’s use of the evidence to be arbitrary or capricious. Having rejected the in- dividual objections, we also reject the overall claim of error. We find the Administrator’s analysis of the evi- dence and assessment of the risks to be well within the flexibility allowed by the “will endanger” standard. Ac- cordingly, we affirm his determination that lead emis- sions “present a significant risk of harm to the health of urban populations, particularly to the health of city children.” 38 FED. REG. 33734. IV. EPA PROCEDURES Petitioners’ last major objection to the low-lead regu- lations is the claim that they are procedurally defective in that, after allowing a total of three formal comment periods, the Administrator did not allow a fourth prior to issuing the regulations.”* Petitioners claim this de- not adequately appraise and act against environmental threats. Truly independent scientific opinion, represented by com- ments from those with no association with environmental groups cr industry, favored the regulations by a margin of approximately two to one. JA 5. We also note that the California Air Resources Board has recently adopted regulations imposing a more stringent lead reduction schedule than is imposed by the regulations before us. See N.Y. Times, Feb. 20, 1976, at 12 col. 3. *° Since EPA never stopped accepting comments on the proposed regulations, the comment period on these regulations actually lasted almost two years. All comments were made public when they were received, in accordance with the pro- cedure established by EPA’s notices of proposed rule-making. See, e.g., 38 FED. REG. at 1260, JA 17; 17 Feb. REG. at 3882, JA 23. Moreover, in keeping with his statutory mandate to consider “all relevant medical and scientific evidence avail- able to him,” § 211(c) (2) (A), 42 U.S.C. § 1857f-6c(c) (2) (A) (emphasis added), the Administrator considered com- POOR COPY OTe ge a> ASE EDS, PTET: CH ELOR IRE fet RR UE Sa | STL GIST LI TELS ARERR ARTS TD 98 prived them of administrative due process in contraven- tion of the demands of Section 4 of the Administrative Procedure Act, 5 U.S.C. § 553 (1970). Ethyl Br. at 50; PPG/duPont Br. at 43; Nalco Br. at 64; NPRA Br. at 44. We find the argument to be without merit. Section 4 requires that prior to final promulgation of a rule the agency must make public “either the terms or substance of the proposed rule or a description of the subjects and issues involved.” 5 U.S.C. § 553(b) (3). The courts have added useful flesh to this statutory lan- guage. The notice should be sufficiently descriptive of the “subjects and issues involved” so that interested parties may offer informed criticism and comments. See, e.g., Portland Cement Assn Vv. Ruckelshaus, 158 U.S.App. D.C. 308, 325-327, 486 F.2d 375, 392-394 (1973), cert denied, 417 U.S. 921 (1974): Mobil Oil Corp. v. FPC, 157 U.S.App.D.C. 235, 248 n.39, 483 F.2d 1238, 1251 n.39 (1973). But the notice need not contain “every precise proposal which |the agency] may ultimately adopt ments received throughout this extended comment period. See pp. 109-110 & note 123 infra. NPRA claims that placing the new studies in the public file did not satisfy EPA’s obligations because “EPA did not notify the public of the availability of these documents or that it intended to rely upon them in promulgating the final regula- tions.” NPRA Reply Br. at 17. This statement is not accur- ate, since EPA’s public notice of the proposed low-lead rule- making, supra, stated that all new information received con- cerning the proposed regulations would be made available for public inspection at its Office of Public Affairs. 38 Fen. REG. at 1260, JA 17. Moreover, NPRA’s own submissions refer to documents contained in the EPA public file. See JA 1962; Doc. 1259. See also Doc. 1089 (letter from Ethyl, dated Oct. 12, 1973, requesting that certain documents not yet in the public file be placed there). Since the statute requires the Administrator to consider all evidence available to him, the complaint that petitioners could not know the Admin- istrator would make use of the material in the public file is un- impressive. 99 as a rule.” California Citizens Band Assn v. United States, 375 F.2d 48, 48 (9th Cir.), cert. denied, 389 U.S. 844 (1967). This last qualification is important since the notice invites comments and the comments will frequently prompt changes in the ultimate regulations. There is nothing in Section 4 that requires new notice whenever the agency responsibly adopts the suggestions of interested parties. Nonetheless, in this case the Ad- ministrator did just that. When, after two comment rounds, criticism of the regulations originally proposed prompted him to alter somewhat the theories on which he was acting, he did not simply promulgate final rules based on these new theories. Rather, he reproposed the regulations as amended and opened them up for a third comment round. It was only when the final regulations were issued that the Administrator omitted a fourth comment period. There was no reason for further com- ment. The Agency theories underlying the final regula- tions were identical with those of the Second Health Document and reproposed regulations. The Third Health Document differs from the Second only in that it incor- porates new information received since the reproposal and responds to the comments. The only change in the regulations as issued was the switch. supported by com- ments from a majority of refiners, from leaded pool averaging to total pool averaging.’ *° The reproposed regulations had made clear that these two alternatives were under consideration and that, at the time, the Administrator favored leaded pool averaging. 38 FED. REG. 1260 (1973). When the majority of industry com- ments favored use of the total pool system, 38 FED. REG. 33739 (1973), the Administrator shifted his position. While we think the notice at 38 FED. REG. 1260 was a sufficient basis for a change in position in the final regulations, the Administrator gave actual notice of the change to the re- finers several months before the final regulations were pro- mulgated. See NPRA letter dated Oct. 25, 1973, JA 1962. Moreover, petitioner NPRA submitted comments on that change. See id. 100 All significant new information developed during the rule-making in this area on the frontiers of scientific knowledge was made available to petitioners and the pub- lie for comment well in advance of issuance of the final regulations on November 28, 1973." Thus both the re- quirements and the spirit of Section 4 were complied with. Nevertheless, the dissent vigorously and at length "* attacks the Administrator’s use of several stud- *t Since all material information was made available for comment by petitioners and the public, it is not necessary for us to determine whether the Administrator may rely on information not previously made available. *°? By contrast, the division majority allotted less than one and a half pages of its 73-page opinion to this argument. Petitioners also treated this contention as a minor part of their attack on the regulations. The major thrust of the dis- sent’s complaint appears to be that although all of the evi- dence on which the Administrator relied was made available to the public at least three months before the regulations were issued, that evidence was not specifically delivered to or called to the attention of petitioners when it arrived at EPA. The dissent does not explain the origin of this supposed responsi- bility of the Agency. Certainly the APA’s requirement of opportunity for notice and comment is satisfied by placing evidence in a designated public access file and repeatedly announcing the existence and location of that file in the FED- ERAL REGISTER. See note 99 supra. Thus the dissent’s chart of the availability of new evidence, dissent at 49, is funda- mentally misleading. All interested parties had legally ade- quate notice of the evidence relied on by the Administrator, and of his intent to rely, see note 99 supra, from the time that evidence was placed in the public file. The dissent attempts to avoid this fact by repeatedly la- menting that EPA’s public file was “poorly indexed” (and dusty). Dissent at 20 n.34, 27, 45-47. On examination this entire attack turns out to be based on the excuse offered by EPA’s attorney for a slight delay in providing a document to this court. See id. at 20 n.34. Had petitioners complained that they were not able to use the public file, we would of course have treated that complaint as a serious matter. But e crnemernctcamematmmneamemmmmems RAT NN aR HOLT EEA SEN OME, , IROUGH 101 ies, alleging they were not made available for comment. A brief review of the record relating to these studies demonstrates that this attack is without merit. 1. The Pilot Lead Isotope Study. The pilot lead iso- tope study consists of two separately reported experi- ments which produced similar results.’’* One of these experiments was presented in a paper delivered at the October 1-2, 1973 Conference on Low Level Lead Toxicity sponsored by EPA and HEW and has apparently not been published elsewhere. However, the results of this experiment were reported to EPA in a letter dated Aug- ust 28, 1972, and placed in the public file at that time. Doe. &75."* More significantly, a draft report of the companion experiment was received by EPA and placed in the public file in early May of 1978. Doc. 470, dated May 5, 1978. The final version of this study, which was eventually published in November 1973, was made avail- petitioners made no such allegation, nor did they suggest that EPA’s public file procedures were in any way less adequate than the procedures customarily followed by administrative agencies. It may well be that the public reference procedures of this still relatively new agency can be improved. But we see no basis for a hypothesis, really a speculation, that persons affected are so unable to use the public file that minimal fair- ness is lacking. In any event that complaint was not made by able and experienced counsel for petitioners. 3 Rabinowitz ef al., “Study of human lead metabolism using stable isotope tracers,” paper presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N. C., Oct. 1-2, 1973, JA 678; Rabinowitz et al., ““Lead Metabolism in the Normal Human: Stable Isotope Studies,” 182 SCIENCE 725- 727 (1973), JA 704. 4 See also EPA letter of Oct. 2, 1975. That letter and a letter of Sept. 26, 1975 were responses to requests for in- formation from this court. Copies of these letters were sent by EPA to counsel for all parties to this litigation. No party commented on either letter. POOR COPY tg AEA RESO In Rak, spit aaekantie) Ald RCIA 2 SS BORON Ra er eel bl SES BT = SE an TIN Sey | ee PE ORR, 28s Pi °F 102 able to Ethyl and placed in the public file in early Aug- ust 1973."° Thus the pilot lead isotope study was avail- able for comment and criticism well before the regula- tions were promulgated.” 2. The Unpublished Japanese Study. The dissent places great stress on the fact that this unpublished and undated draft"? bears an inscription prohibiting cita- tion or quotation. Dissent at 21. We note first that since the study was prepared and submitted to EPA by the International Lead Zine Research Organization, an indus- try group including these petitioners, Government Supp. Br. at 46, their claim of prejudice from the Administra- tor’s use of the study rings false. Moreover, the study was placed in the public file and sent to petitioner Ethyl '°® The final draft was received by EPA’s Office of the Gen- eral Counsel Aug. 6, 1975, for transmittal to Ethyl, see note 117 infra, and to the public file. EPA letter of Sept. 26, 1975. '°° Nalco Chemical Co. submitted extensive comments on the scientific evidence, including comments directed specifically at the lead isotone study, on Nov. 19, 1973. Doe. 821 at 7. Ethyl also submitted comments on this study in the form of a transcript of the October conference. Doc. 433. The dissent finds it strange that we consider this transcript a substantive comment on the studies discussed at the meet- ing. Dissent at 41, 45. In response, we simply note that the only possible interpretation of Ethyl’s action in prepar- ing and submitting the transcript was that the company wished to have the critical comments of its scientists and some others who attended the meeting brought to EPA’s attention as substantive critiques of the studies. A covering letter from Ethyl’s counsel which accompanied the company’s submission of the transcripts of a Feb. 26 and 2 Merch 15 meeting explicitly states this purpose. See JA 986. '*' Tsuchiya et al., Study of Lead Concentrations in Atmo- “spkere and Population in Japan (undated), JA 1092. BLEED THRO yeas ‘ Be i : hae oe Pere a IROUGH 103 some four months before the Administrator’s decision was announced.’” 3. The Chamber Study. The dissent attempts to build an argument from the fact that the Second Health Docu- ment cites the chamber study’ as a “preprint” whereas the Third references the study to the printed proceed- ings of the international symposium at which the paper was delivered. Dissent at 22, 28. But see id. at 23. How- ever, comparison of the “preprint” with the final publica- tion shows that they are absolutely identical.° Thus the chamber study was in the public realm from the beginning of the formal comment period on the repro- posed regulations. 4. The Seven Cities Study. The dissent criticizes only the Administrator’s reliance on an EPA reanalysis of the data on which this study was based, since it is conceded that the study itself '"’ was available at the 18 The study was received by EPA’s Office of the General Counsel on July 22, 1973, for transmittal to Ethyl, see note 117 infra, and to the public file. EPA letter of Sept. 26, 1975. It too was commented on by Nalco. Doc. 821 at 7. Since the study was available for comment four months prior to issu- ance of the Administrator’s decision, we find the significance of the fact that it was not cited in the Third Health Docu- ment, dissent at 22, mystifying. '°° Knelson et al., Kinetics of Respiratory Lead Intake in Humans, PROCEEDINGS OF THE INTERNATIONAL SYMPOSIUM ON ENVIRONMENTAL ASPECTS OF LEAD 391-401 (1973), JA 596. "© Compare Doc. 85, JA 596-601, with Doc. 111 at 391-401. The final printed “version” differs from the “preprint” only in that the former contains a translation of the authors’ sum- mary into French and German. '! Tepper & Levin, “A Survey of Air and Population Lead Levels in Selected American Communities,” Department of Environmental Health, College of Medicine, University of Cincinnati, Cincinnati, Ohio (1972), JA 840. POOR COPY 104 beginning of the formal comment period. Dissent at 22- 23, 28-29. Three facts vitiate this criticism of the Ad- ministrator’s reliance on the Seven Cities Study. First, the dissent is simply incorrect when it implies that the Administrator relied only on the “additional analysis.” Dissent at 28. The Administrator actually relied pri- marily on a finding reported in the original study. See page 86 & note 92 supra. The reanalysis merely re- confirmed the validity of that finding."? Second, the 2 The dissent’s emphasis on the importance of the re- analysis of the Seven Cities Study appears to be based on a misunderstanding of the meaning of statistical significance. Statistical significance simply expresses the level of assur- ance we can have that certain data was not the product of random relationships. See, e.g., F. MOSTELLER, R. ROURKE & G. THOMAS, PROBABILITY WITH STATISTICAL APPLICATIONS 304-307 (2d ed. 1970). Unfortunately, the word “significant” in everyday use means not only “suggestive” but also “important” and “weighty”. We do not carry these everyday meanings over into statistics. * * * A statistically significant result is one that the data support as showing a real effect, as opposed to a result that might readily arise from sampling variation. Id. at 307. Typically, scientists refuse to certify an observed relation- ship as “significant” unless they are 95% certain that the data could not have been generated randomly. See note 58 supra. Thus the authors of the Seven Cities Study found the relation- ship between air and blood lead levels between cities “ [n]ot significantly different from 0 at the 5% level,” JA 902, mean- ing that they could not be certain that if there were no genuine relationship in the real world, the relationship that was ob- served in this study would be found in at most five out of every 100 randomly drawn data samples. On reanalyzing the data using more refined techniques, EPA’s scientists determined that the observed relationship could be expected to be pro- duced by chance less than one time out of 1,000. See Doc. 228 at Table 3. Sisiilarly, the authors of the Seven Cities Study themselves recognized the implication of their “consistent "4 ore LHP AOR ETE CRE MOE REL RR OE PRS PGS TR med Fs ies 5 RADA ELT GE OLE LIE OPTS EIS 105 reanalysis itself is just EPA’s effort to reexamine the study in light of the critical comments received on it.’** It would be unreasonable to require another formal com- ment period whenever an agency determines that com- ments received during a preceding comment period do not undermine the validity of a particular piece of evidence. Finally, EPA made the reanalysis public in February 1973.** observation” that blood lead levels were higher in a given metropolitan area’s urban region than in its suburbs. See p. 86 & note 92 supra. The reanalysis simply demonstrated that this “consistent observation” has less than a one in 1,000 likelihood of being the product of chance. See Doc. 228 at Table 3. There is, of course, no reason why the Administrator can- not rely on observed relationships among data which he is less than 95% certain reflect a true underlying relationship between the phenomena that the data measure. See note 58 supra. The dissent’s assertion that only the reanalysis pro- vides support for the Administrator’s decision assumes that the Administrator must be 95% certain before he credits any evidence. 13 The purpose and contents of the reanalysis are described by its first sentence: “This brief paper is an attempt to an- swer questions raised by reviewers about the statistical analy- ses performed [in the Seven Cities Study]. Doc. 228 at 1. ™4The results and methodology of the reanalysis were presented and discussed at a meeting of the EPA Hazardous Materials Advisory Committee on Feb. 26, 1973. JA 989-992. Representatives of Ethyl attended the meeting, prepared a transcript of it, including critical comments by some of those in attendance, and forwarded the transcript to the Adminis- trator. JA 985; see note 106 supra. The dissent strives might- ily to show that the reanalysis was not in the public domain until four days after the close of the formal comment period, rather than 13 days before. Dissent at 23. Even if this were true, the important point is that the reanalysis was available for public comment some nine months prior to issuance of the regulations. ee oe . ~~ —— Ns 106 5. The Newark, Rochester, Philadelphia, and Chicago Studies. The only clear references to these studies,'* which bear on the validity of the dustfall hypothesis, occur in a portion of the Administrator’s decision that addresses the question, “What new infcrmation has be- come available since reproposal of the regulation and as a result of the additional comment period?” JA 5. This section of the decision follows the Administrator’s ex- planation and justification of his conclusion that “lead particle emissions from motor vehicles present a signifi- cant risk of harm to the health of urban populations, particularly to the health of city children.” JA 2. See JA 2-5. The Administrator was required to take account of the new information by the statute, which directs him to consider “all relevant medical and scientific evi- dence available to him.” Section 211(c)(2)(A), 42 U.S.C. § 1857f-6e(c) (2) (A) ‘emphasis added). Moreover, as the Administrator’s placement of the discussion of these studies makes clear, the studies are not needed or used to support the conclusion that the dustfall hypothesis is reasonable. That conclusion is a "5 Margulis et al., Residential Location, Ambient Air Lead Pollution and Childhood Lead Poisoning, — ARCH. ENV. HEALTH — (in press at time record was compiled), JA 626; Sayre et al., House and Hand Dust as a Potential Source of Childhood Lead Exposure, — AM. J. Dis. CHILD — (in press at time record was compiled); and Vostal et al., “Lead Contain- ing House Dust: Another Source of Increased Lead Exposure in Inner City Children,” paper presented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N. C., Oct. 1-2, 1973, JA 720, 738; Needleman & Shapiro, “Dentine Lead Levels in Asymptomatic Philadelphia School Children: Sub- clinical Exposure in High and Low Risk Groups,” paper pre- sented at EPA-NIEHS Conference on Low Level Lead Toxicity, Raleigh, N. C., Oct. 1-2, 1973, JA 662; Sachs, “Effects of a Screening Program on Changing Patterns of Lead Poisoning,” paper presented at EPA-NIEHS Confer- ence on Low Level Lead Toxicity, Raleigh, N. C., Oct. 1-2, 1973, JA 718. —— a a 107 sufficient basis for regulation under the statute. See pages 16-36, 90 supra. These additional studies, which are corroborative of the dustfall hypothesis, see pages 91-93 supra and Appendix B to this opinion, play no role in the Administrator’s decision to regulate.’** Finally, petitioners and the dissent suggest that even if all the new studies were made available to the public for comment well before the Administrator reached his decision, Section 4 of the APA requires still another procedural step: that the Administrator, before arriv- ing at his decision, publicly identify the recently re- ceived studies and comments on which he intended to rely so that the public might have yet another oppor- tunity to comment on that material. If this new round of comments provided any significant information, the Administrator would presumably be able to use that information only if he formally stated his intent to do so and allowed still another round of comments. For obvious reasons, there is no support for this novel sug- gestion in the Act or in the jurisprudence.’” 1% Compare JA 1-5 (the text of the Administrator’s deci- sion) with JA 186-193 and JA 231-239 (discussions of the dustfall hypothesis in the Second Health Document). 17 The dissent cites no authority at all in that part of its argument which focuses on the asserted need for notice of intent to rely. See dissent at 31-32, 42-50. The authorities cited in the same section of the dissent, see id. at 33-35 & nn.78-80, support only the proposition that an agency may not keep secret the purpose of its proceeding or information im- portant to its decision. The citation to K. DAvis, ADMINIS- TRATIVE LAW TREATISE § 15.10 at 402 (1958), dissent at 34 n.78, refers to a discussion of the “Procedures for Using and Challenging Extra-Record Facts” of which an administrative decision maker has taken notice during an adjudicatory pro- ceeding. Since all of the studies at issue here were disclosed by the Administrator as soon as they became available to him, not kept secret, and since there could be no allegation that any of this material was not part of the record properly be- EE — PO ee ee 108 The record in this case clearly demonstrates that EPA fully satisfied the requirements of administrative due process. In fact, EPA’s efforts to elicit informed comment on its proposed action went far beyond the measures it was required to take. All health-related documents, in- cluding internal EPA policy memoranda, were made public upon receipt," and comments on the documents fore the Administrator, these authorities are of no assistance to the dissent’s argument. Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., supra note 73, quoted, dissent at 35, also offers no support for the proposition that the APA requires notice of what material received and made public after pub- lication of a proposed rule will be relied on to support the final regulation. In the first place, Bowman was an adjudicatory proceeding, not a notice-and-comment rule-making. More im- portantly, in the sentence immediately following the language quoted by the dissent the Supreme Court noted that a party’s right “to be apprised of the factual material on which the agency relies for decision” does “not preclude a factfinder from observing strengths and weaknesses in the evidence that no party identified.” 419 U.S. at 288 n.4. The Adminis- trator’s treatment of the Seven Cities Study, as well as of the Japanese study submitted by lead industry opponents of the proposed regulation, fits squarely within this observation. Moreover, the Bowman Court also noted that the petitioners there “are not in a position to claim unfair surprise” because the Commission had offered the same rationale for its inter- pretation of evidence in a case decided at the time the hearings in Bowman were beginning. Jd. at 289 n.4. That rationale, it should be noted, was potentially rebuttable. In the face of this conclusion, the assertion that petitioners were not on notice that the agency might rely on information in the public record of this rule-making proceeding appears frivolous. Finally, we note that nothing in Wright, The Courts and the Rulemaking Process: The Limits of Judicial Review, 59 CORNELL L. REV. 375 (1974), supports the dissent’s attempt to transmute the three-step process established by § 4 into a potentially unending and fruitless series of notices, comments, and notices of intent to rely on comments. "* See note 99 supra. Indeed, petitioner Ethyl was directly furnished with all such documents as a result of a Freedom eee ee — "eer Qery: Beer BLEED THROU = , eee Ae ee Se eS ESTE IN NPE RRO OL EPR SERNST PPI OTR UGH 109 were accepted until the date of final promulgation. These documents included drafts of the Administrator’s decision whose contents were very similar to the version finally published *" and a draft of the Third Health Docu- ment which was substantially identical to the final draft." Both the draft of the Administrator’s decision and the regulations and the draft of the Third Health Document were circulated for comment, and comments were received = and acted upon.’ On this record, we 11a of Information Act, 5 U.S.C. § 552 (1970), suit. JA 1509- 1510. See Ethyl Corp. v. EPA, 478 F.2d 47 (4th Cir. 1973). 4° The dissent’s effort to demonstrate that little comment was received about the most recent of the studies relied on by the Administrator is irrelevant. All the APA requires is that there have been an opportunity to comment. The three months between the time the important new studies were placed in the public file and the time of the Administrator’s decision is clearly sufficient opportunity. 12° Joy 1474; JA 1502. * Doc. 141. Chapters I, Il, V, VII, and VIII (the conclu- sions) of this draft, dated Oct. 19, 1973, differ only in minor wording changes from the final Third Health Document. Chapters III, IV, and VI of the final version contain a few ad- ditional inconsequential paragraphs and references. The cover of the Oct. 19 draft states that “[i]t is being circulated for comment on its technical accuracy and policy implications.” The early October preparation and circulation of a draft decision and a draft Third Health Document, both in ob- viously near final form, belie the dissents’ contention that this court’s 30-day order, see p. 14 supra, forced EPA to rush into a decision it was not yet ready to make. 122 See, e.g., JA 2577 (Treasury Department comments) ; JA 2651 (letter from Secretary of Transportation); JA 2493 (Department of the Interior comments, dated Dec. 7, 1973). The Nalco comments, see note 106 supra, were addressed to both the draft Third Health Document and the draft of the Administrator’s decision. 23 See Ethyl letter dated Oct. 29, 1973, Doc. 1090, present- ing evidence considered in the Third Health Document, JA 79 POOR COPY HOMME LE ST TED NG IA, et oy tadlashe Choe iad ae « e = ee ee me owes —~ ~ 110 cannot find that petitioners were deprived of administra- tive due process by EPA procedures.’ (ref. 11) & 140 (ref. 43). The Ethy] letter called this evidence to EPA’s attention because “[t]o our knowledge these highly significant articles have not been referred to by EPA to date in its consideration of the health question * * *.” Doc. 1090 supra. The timing of this letter suggests that Ethyl was re- ferring to EPA’s failure to reference these articles in the Oct. 19 draft of the Third Health Document. Ethyl would have received that draft due to its Freedom of Information Act suit. See note 118 supra. *** Beyond their attacks on the Administrator’s interpreta- tion of the statutory language, the evidence, and the proced- ures, petitioners raise a host of other objections to the final EPA regulations. We have considered above petitioners’ claims that the Administrator did not properly consider the possibility of regulation under § 202, see note 66 supra, and that he did not make a valid finding that any substitute addi- tive would be less dangerous than lead, particularly in light of his recent suspension of 1977 statutory emission standards. : See notes 67-68 supra. Cf. note 2 supra. We shall briefly ad- : dress petitioners’ remaining contentions. Ethyl claims a right to cross-examine agency witnesses. Ethy! Br. at 55. Not only does the Clean Air Act not require any hearings at all, but even if hearings were required cross- examination is not mandated in § 4 type proceedings, 5 U.S.C. § 553. United States v. Florida East Coast R. Co., 410 U.S. 224, 240 (1973). Petitioners were afforded a meaningful opportunity to be heard and to controvert the evidence. Fair- ness demands no more. See International Harvester Co. V. Ruckelshaus, 155 U.S.App.D.C. 411, 427, 478 F.2d 615, 631 (1973). PPG, duPont and NPRA claim the Administrator was re- quired to set ambient air standards for lead under § 108, 42 U.S.C. § 1857e-3, before acting under § 211, and his failure to do so warrants reversal. PPG/duPont Br. at 45; NPRA Supp. Br. at 37-47. There is no basis in the statute for this claim. While § 211 expressly mentions consideration of regu- lation under § 202, it makes no mention at all of § 108. More over, the Administrator claims, with some statutory support, 4 RI EEN THRO elec =| 111 V. CONCLUSION The complex scientific questions presented by this rule- making proceeding were “resolved in the crucible of debate through the clash of informed but opposing scien- that action under § 108 is discretionary with him. 38 FED. REG. 33740 (1973). Cf. note 21 supra. Nalco, PPG and duPont all claim that the Administrator did not give sufficient consideration to the adverse economic effects of his decision to regulate lead additives. Nalco Br. at 42; PPG Br. at 40. Even if the Administrator is allowed to consider at all the economic effects of regulations issued under § 211(c) (1) (A), a question we do not address, he has plainly both well understood and considered the consequences of these regulations and found them to be minimal. 38 FED. REG. 33739 (1973). We cannot say his judgment was irrational. NPRA objects to the Administrator’s switch from leaded pool averaging to total pool averaging. NPRA Supp. Br. at 47- 48. EPA switched in response to the comments of a majority of refiners. 38 FED. REG. 33739. We find nothing wrong with the use of that system. We discussed at note 100 supra the propriety of the Agency’s announcing this change when prom- ulgating its final regulations. Lastly, Ethyl, PPG, duPont and NPRA claim that EPA was required to file an environmental impact statement under $ 102(2)(C) of the National Environmental Policy Act, 42 U.S.C. § 4332(2)(C) (1970), or the functional equivalent of one. Ethyl Br. at 57; PPG Br. at 46; NPRA Br. at 53. So far as EPA regulation under § 211 is concerned, we answered this question in Amoco, and recent legislation has made the point doubly clear. An environmental impact statement from EPA does not appear necessary; a “functiona! equivalent” suffices. The Amoco court held that when the Administrator has considered the evidence and alternative courses of action required before action under § 211 is permitted, he has neces- serily furnished the “functional equivalent” of an impact statement. Amoco Oil Co. v. EPA, supra note 2, 163 U.S.App. D.C. at 189-190, 501 F.2d at 749-750. Since we believe the Administrator has complied with all the demands of § 211 in this case, we believe he has likewise complied with NEPA. [continued } DoDHnnm CHoODY Aen SARRR R P ee _ = eS 2 WY S a ae Ae = ee * . aaeue 112 tifie and technological viewpoints.” International Har- vester Co. Vv. Ruckelshaus, 155 U.S.App.D.C. 411, 448, 478 F.2d 615, 652 (1973) (concurring opinion of Chief Judge Bazelon). On January 31, 1971 the EPA began the debate by publishing advance notice of proposed rule- making concerning possible controls on lead additives : in gasolines because of their possible danger to health. On February 23, 1972 it published the proposed regula- 7 tions supported by a document, Health Hazards of Lead (First Health Document), prepared by the EPA scien- tific staff. It invited comment from the lead industry, : the scientific community, and the concerned public. The EPA held public hearings in Washington, D.C., Dallas, 7 and Los Angeles to give people across the country an opportunity to join the debate. q On January 10, 1973 the EPA reproposed the regula- tions in slightly changed form, supported by a Second Health Document which reflected the scientific comments on the first and brought the scientific information on the subject up to date. Scientific studies, pro and con, i which had become available since the proposed regula- ; tions were first published were included. Again the ; EPA invited the parties, the scientific community, and ‘ the concerned public to comment. Finally, on November 28, 1973, almost three years after the debate was joined, the EPA promulgated its regulations accompanied Any lingering doubt in this regard has been removed by recent congressional action. The Energy Supply and Environ- mental Coordination Act of 1974, Pub. L. No. 93-319, 88 STaT. 246 (1974) (codified at 15 U.S.C. §791 et seq. (Supp. IV 1974)), provides: “No action taken under the Clean Air Act shall be deemed a major Federal action significantly affecting the quality of the human environment within the meaning of the National Environmental Policy Act of 1969.” Jd. § 7(c) (1), 15 U.S.C. §793(c) (1). Thus Congress has expressly exempted EPA action under the Clean Air Act from NEPA’s environmental impact statement requirement. BLEED THRC a 113 by a 10,000-word opinion, thoroughly and comprehen- sively analyzing the various scientific studies and giving its reasons why it resolved the scientific debate it had provoked in favor of protecting the public from the danger of lead emissions. A Third Health Document, extensively detailing and reviewing the current state of scientific knowledge of the health effects of airborne lead, also accompanied the regulations and the reasons for their issuance. Because of the importance of the issues raised, we have accorded this case the most careful and exhaustive consideration. We find that in this rule-making pro- ceeding the EPA has complied with all the statutory procedural requirements and that its reasons as stated in its opinion provide a rational basis for its action. Since we reject all of petitioners’ claims of er [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385609_0192%3A1. Public record. Not legal advice.