Opinion ID: 338705
Heading Depth: 1
Heading Rank: 4

Heading: epa procedures

Text: 133 Petitioners' last major objection to the low-lead regulations 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. 99 Petitioners claim this deprived them of administrative due process in contravention 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. 134 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 language. 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 v. Ruckelshaus, 158 U.S.App.D.C. 308, 325-327, 486 F.2d 375, 392-394 (1973), cert denied, 417 U.S. 921, 94 S.Ct. 2628, 41 L.Ed.2d 226 (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 as a rule. California Citizens Band Assn v. United States, 375 F.2d 43, 48 (9th Cir.), cert. denied, 389 U.S. 844, 88 S.Ct. 96, 19 L.Ed.2d 112 (1967). This last qualification is important since the notice invites comments and the comments will frequently prompt changes in the ultimate regulations. 135 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 Administrator 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 comment. The Agency theories underlying the final regulations were identical with those of the Second Health Document and reproposed regulations. The Third Health Document differs from the Second only in that it incorporates new information received since the reproposal and responds to the comments. The only change in the regulations as issued was the switch, supported by comments from a majority of refiners, from leaded pool averaging to total pool averaging. 100 136 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 public for comment well in advance of issuance of the final regulations on November 28, 1973. 101 Thus both the requirements and the spirit of Section 4 were complied with. Nevertheless, the dissent vigorously and at length 102 attacks the Administrator's use of several studies, 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. 137 1. The Pilot Lead Isotope Study. The pilot lead isotope study consists of two separately reported experiments which produced similar results. 103 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 August 28, 1972, and placed in the public file at that time. Doc. 875. 104 More significantly, a draft report of the companion experiment was received by EPA and placed in the public file in early May of 1973. Doc. 470, dated May 5, 1973. The final version of this study, which was eventually published in November 1973, was made available to Ethyl and placed in the public file in early August 1973. 105 Thus the pilot lead isotope study was available for comment and criticism well before the regulations were promulgated. 106 138 2. The Unpublished Japanese Study. The dissent places great stress on the fact that this unpublished and undated draft 107 bears an inscription prohibiting citation or quotation. Dissent at --- of --- U.S.App.D.C., at 80 of 541 F.2d. We note first that since the study was prepared and submitted to EPA by the International Lead Zinc Research Organization, an industry group including these petitioners, Government Supp.Br. at 46, their claim of prejudice from the Administrator's use of the study rings false. Moreover, the study was placed in the public file and sent to petitioner Ethyl some four months before the Administrator's decision was announced. 108 139 3. The Chamber Study. The dissent attempts to build an argument from the fact that the Second Health Document cites the chamber study 109 as a preprint whereas the Third references the study to the printed proceedings of the international symposium at which the paper was delivered. Dissent at ---, --- of --- U.S.App.D.C., at 80, 83 of 541 F.2d. But see id. at --- of --- U.S.App.D.C., at 80-81 of 541 F.2d. However, comparison of the preprint with the final publication shows that they are absolutely identical. 110 Thus the chamber study was in the public realm from the beginning of the formal comment period on the reproposed regulations. 140 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 111 was available at the beginning of the formal comment period. Dissent at --- - ---, --- - --- of --- U.S.App.D.C., at 80-81, 83 of 541 F.2d. Three facts vitiate this criticism of the Administrator'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 --- of --- U.S.App.D.C., at 83 of 541 F.2d. The Administrator actually relied primarily on a finding reported in the original study. See page --- of --- U.S.App.D.C., & note 92 supra, page 42 of 541 F.2d, & note 92 supra. The reanalysis merely reconfirmed the validity of that finding. 112 Second, the reanalysis itself is just EPA's effort to reexamine the study in light of the critical comments received on it. 113 It would be unreasonable to require another formal comment period whenever an agency determines that comments 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. 114 141 5. The Newark, Rochester, Philadelphia, and Chicago Studies. The only clear references to these studies, 115 which bear on the validity of the dustfall hypothesis, occur in a portion of the Administrator's decision that addresses the question, What new information has become 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 explanation and justification of his conclusion that lead particle emissions from motor vehicles present a significant 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 evidence available to him. Section 211(c)(2)(A), 42 U.S.C. § 1857f-6c(c)(2) (A) (emphasis added). 142 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 sufficient basis for regulation under the statute. See pages --- - ---, --- of --- U.S.App.D.C., pages 11-20, 44 of 541 F.2d supra. These additional studies, which are corroborative of the dustfall hypothesis, see pages --- - --- of --- U.S.App.D.C., pages 44-46 of 541 F.2d supra and Appendix B to this opinion, play no role in the Administrator's decision to regulate. 116 143 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 arriving at his decision, publicly identify the recently received studies and comments on which he intended to rely so that the public might have yet another opportunity 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 suggestion in the Act or in the jurisprudence. 117 144 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, including internal EPA policy memoranda, were made public upon receipt, 118 and comments on the documents were accepted until the date of final promulgation. 119 These documents included drafts of the Administrator's decision whose contents were very similar to the version finally published 120 and a draft of the Third Health Document which was substantially identical to the final draft. 121 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 122 and acted upon. 123 On this record, we cannot find that petitioners were deprived of administrative due process by EPA procedures. 124 V. CONCLUSION 145 The complex scientific questions presented by this rule-making proceeding were resolved in the crucible of debate through the clash of informed but opposing scientific and technological viewpoints. International Harvester Co. v. 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 regulations supported by a document, Health Hazards of Lead (First Health Document), prepared by the EPA scientific 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, and Los Angeles to give people across the country an opportunity to join the debate. 146 On January 10, 1973 the EPA reproposed the regulations 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, which had become available since the proposed regulations 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 by a 10,000-word opinion, thoroughly and comprehensively 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. 147 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 proceeding 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 error the Agency may enforce its low-lead regulations. 148 Affirmed.