# Petition — Eli Lilly and Company v. Douglas M. Costle, Administrator, Environmental Protection Agency > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385006_0971%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition - **Published:** January 1, 1980 - **Citation:** 444 U.S. 1096 ## Text ‘ FIL D IN THE Supreme Court of the Uuil ICHAEL RODAK, JR., CLERK OCTOBER TERM, 1978 ~ No. 79-485 ELI LILLY AND COMPANY, Petitioner DouGLAs M. CosTLE, ADMINISTRATOR, ENVIRONMENTAL PROTECTION AGENCY PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FIRST CIRCUIT ‘Of Counsel: CLEARY, GOTTLIEB, STEEN & HAMILTON 1250 Connecticut Ave., N.W. Washington, D.C. 20036 September 21, 1979 DOUGLAS E. KLIEVER CHARLES F. LETTOW JOHN S. MAGNEY WILLIAM N. HALL 1250 Connecticut Ave., N.W. Washington, D.C. 20036 JOHN C. JENKINS 307 E. McCarty Street Indianapolis, Indiana 46206 Counsel for Petitioner Eli Lilly and Company WILSON - EPES PRINTING Co., INC. - 789-0096 - WASHINGTON, D.C. 20001 ae TABLE OF CONTENTS ahs daceenerneenaicinindepitnecinnctapanesantiinene Nee iaicidincenncphinniasanastbiceacaencraserioccaseosese ke gi: | ee I I oc oscsrcmeninmenatrcnerensoncemmneerenenente ER see ee REASONS FOR GRANTING THE PETITION............. I. THE ISSUES PRESENTED TO THIS COURT II. ARE IMPORTANT ISSUES WHICH SHOULD BE RESOLVED BY THE COURT TO PRO- VIDE GUIDANCE TO THE COURTS OF AP- PEALS AND TO THE ADMINISTRATIVE a reisiaeatih ec eelapinieeinatoncinsstoernnepaanene THE FIRST CIRCUIT’S DETERMINATION THAT THE ADMINISTRATOR COMPLIED WITH THE NOTICE-AND-COMMENT RE- QUIREMENTS OF THE APA CONFLICTS WITH THE DECISIONS OF OTHER COURTS OF APPEALS AND IS INCORRECT ................ A. The Regulations Were Substantially Changed On The Basis Of New Data ............ B. The Decision Is In Conflict With Decisions Of The Courts Of Appeals For The Second, Fourth, And District Of Columbia Circuits.. C. The First Circuit Erred In Deciding That EPA Had Complied With The APA .............. D. Eli Lilly Is Particularly Harmed By The ae 10 10 13 16 19 ii TABLE OF CONTENTS—Continued III. EVEN IF IT WERE ASSUMED THAT EPA WAS NOT REQUIRED TO ISSUE NOTICE FOR PUBLIC COMMENT ON THE REVISED REGULATIONS, THE COURT OF APPEALS’ DECISION TO DEFER TO EPA’S DETER- MINATIONS BASED ON AN EXPANDED DATA BASE WAS INCORRECT AND IN CONFLICT WITH THE DECISION CF AN- OTHER COURT OF APPEALS AND RE- SULTED IN THE COURT SUBSTITUTING ITS JUDGMENT FOR THAT OF EPA ............ A. The Court Of Appeals Deferred To EPA On Matters Not Subject To Public Comment, And Conducted A De Novo Review Of New Data And Information .................................... B. The First Circuit Erred In According Judi- cial Deference To EPA Determinations Based On Data And Information Which Had Not Been Tested By Public Comment ............ C. The First Circuit Impermissibly Substituted Its Judgment For That Of The Agency .......... CI hi sincsenctnpece ence sneitonnielands euninicmncomaianiien Page 22 22 24 26 28 1b et PONT Oe iii TABLE OF AUTHORITIES CASES: American Frozen Food Institute v. Train, 539 F.2d Si tas ING, I hal American Iron and Steel Institute v. Environmen- tal Protection Agency, 568 F.2d 284 (8d Cir. je RRR rae Remini aeet B snr Sil Wiis eA ee Automotive Parts and Accessories Association V. Boyd, 407 F.2d 330 (D.C. Cir. 1968) _..0.0.000000. Bowman Transportation, Inc. Vv. Arkansas-Best Freight System, Inc., 419 U.S. 281 (1974) .......... California Citizens Band Association v. United States, 375 F.2d 43 (9th Cir.), cert. denied, 389 U.S. 844 (1967) -............ PETE CORA ORI CR AT Camp V. Pitts, 411 U.8..188 (1978) ........................ Citizens to Preserve Overton Park v. Volpe, 401 Sm I a a E.I. du Pont de Nemours & Co. v. Train, 430 U.S. 1 | RR TOI inte Saree N SS OR Bah WR VR na as Ethyl Corp. v. Environmental Protection Agency, 541 F.2d 1 (D.C. Cir. 1976), cert. denied, 426 CI A Federal Power Commission v. Transcontinental Gas Pipe Line Corp., 423 U.S. 326 (1976) .......... Federal Trade Commission v. Sperry & Hutchin- rg | | fk Ira ne Home Box Office, Inc. v. Federal Communications Commission, 567 F.2d 9 (D.C. Cir. 1977) .......... International Harvester Co. v. Ruckelshaus, 478 Be Ue ae a aniivetesinccteseunicoceceeenne Marathon Oil Co. v. Environmental Protection Agency, 564 F.2d 1253 (9th Cir. 1977) _............. National Crushed Stone Association v. Environ- mental Protection Agency, 601 F.2d 111 (4th ASRS ES Ear EN St Sere EOE ea Natural Resources Defense Council v. Costle, 12 E.R.C. 18338 (D.D.C. 1979), appeal docketed, No. 79-1473 (D.C. Cir. May 9, 1979) _................. Page 13, 18 9,13 iv TABLE OF AUTHORITIES—Continued Page Portland Cement Association v. Ruckelshaus, 486 F.2d 375 (D.C. Cir. 1973), cert. denied, 417 U.S. GERD (RGD acccareccssiniinsnscsricinendniehabchanaenee 15, 17 Securities Exchange Commission V. Chenery Corp., S88 US. 106 (iOGR). cccicciedekee nee 27 South Terminal Corp. v. Environmental Protection Agency, 504 F.2d 646 (1st Cir. 1974) ............ 12, 16, 17 Texaco, Inc. v. Federal Power Commission, 412 F.28 740 (Ord Gir. TOG) nice 17 United States v. Nova Scotia Food Products Corp., i Bf F 8: f+ , , Renee 9, 18, 15 Wagner Electronics Corp. Vv. Volpe, 466 F.2d 1013 (Sed Civ. 1978). 001i eee 19 Weyerhaeuser Corp. V. Costle, 590 F.2d 1011 (D.C. Cir: BOGS) ..nnccccontincuneeeee 9, 18, 14, 15, 17, 24, 25 STATUTES : Administrative Procedure Act, 5 U.S.C. §551 et seq. Section 4(b) (3), 5 U.S.C. § 553 (b) (3) -......... 2,8 Section 4(c), 5 U.S.C. § 553 (c) ......................... 3 Federal Water Pollution Control Act, as amended, 33 U.S.C. § 1251 et seq. Section 301(b), 33 U.S.C. §1811(b) -............ 3 Section 304(b), 33 U.S.C. § 1814(b) —............. 3 Judicial Code, 28 U.S.C. § 1254(1) ~...............-...------ REGULATIONS AND REGULATORY NOTICES: CODE OF FEDERAL REGULATIONS 4 CFR. § GRRE qe 5 FEDERAL REGISTER NOTICES 41 Fed. Reg. 48087 (Nov. 1, 1976) ................... 3 41 Fed. Reg. 48088 (Nov. 1, 1976) -.................. 3,4 41 Fed. Reg. 48089-90 (Nov. 1, 1976) .............. 5 FT RP ah Pod BEE A BS 2k Vv TABLE OF AUTHORITIES—Continued Page 41 Fed. Reg. 48091 (Nov. 1, 1976)... 3, 20 43 Fed. Reg. 17775 (Apr. 25, 1978) _.............. 1,4 43 Fed. Reg. 44875 (Sept. 29, 1978)... 4 44 Fed. Reg. 38745 (July 2, 1979) ............. 10 44 Fed. Reg. 38764 (July 2, 1979) 10 44 Fed. Reg. 38765 (July 2, 1979)... 10 44 Fed. Reg. 38766 (July 2, 1979) ................. 10 IN THE Siren Court of the United States OCTOBER TERM, 1978 No. ELI LILLY AND COMPANY, Petitioner V. . DOUGLAS M. COSTLE, ADMINISTRATOR, ENVIRONMENTAL PROTECTION AGENCY PETITION FOR A WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FIRST CIRCUIT Eli Lilly and Company petitions for a writ of cer- tiorari to review the judgment of the United States Court of Appeals for the First Circuit in this case. OPINIONS BELOW The opinion of the Court of Appeals (App. A, infra) is reported in 598 F.2d 637. The decision of the Admin- istrator of the Environmental Protection Agency is set forth in regulations published at 43 Fed. Reg. 17775 (App. C, infra). JURISDICTION The judgment of the Court of Appeals (App. B, infra) was entered on May 7, 1979. A timely petition for re- 2 hearing was denied on June 25, 1979. The jurisdiction of this Court is invoked under 28 U.S.C. § 1254(1). QUESTIONS PRESENTED 1. Whether under Section 4 of the Administrative Procedure Act EPA was required to provide notice and an opportunity for public comment before promulgating final regulations which differed substantially from the “interim final” regulations, especially where the Agency had generated a new and more extensive base of data not previously disclosed for public comment? 2. Assuming that EPA was not required to give notice and provide opportunity for public comment, whether the court in carrying out its review of the regulations should defer to those determinations by the Agency which were based on new data? 8. Again assuming that EPA was not required to give notice and provide opportunity for public comment, whether the reviewing court should conduct its own de novo review of new data and information, and impute certain determinations to the Agency, where the Agency’s determinations are either nonexistence or inadequate to deal with the issues in dispute? STATUTE INVOLVED Sections 4(b) (3) and (c) of the Administrative Pro- cedure Act, 5 U.S.C. § 553(b) (3), (c), provide in perti- nent part: § 553. Rule making (b) General notice of proposed rule making shall be published in the Federal Register ... . The notice shall include— 3 (3) either the terms or substance of the proposed i or a description of the subjects and issues in- volved. * « * * (c) After notice required by this section, the agency shall give interested persons an opportunity to participate in the rule making through submis- sion of written data, views, or arguments.... STATEMENT Section 301(b) of the Federal Water Pollution Control Act, as amended, 38 U.S.C. §1311(b), authorizes the Environmental Protection Agency (“EPA” or “Agency”) to issue regulations establishing effluent limitations for classes and categories of industrial point sources. Sec- tion 304(b), 33 U.S.C. § 1314(b), requires EPA to es- tablish guidelines for the purpose of adopting such efflu- ent limitation regulations. See E. I. du Pont de Nemours & Co. v. Train, 430 U.S. 112 (1977). On November 1, 1976, EPA promulgated “interim final regulations” for the Pesticide Chemicals Manufac- turing Point Source Category. 41 Fed. Reg. 48087. The interim final regulations established effluent limitations for existing sources implementing the first-stage require- ment of Section 301(b) for the application of best prac- ticable control technology currently available by July 1, 1977. 1EPA did not publish the regulations in proposed form. Citing an order of the United States District Court for the District of Columbia, EPA determined that the publication of proposed regu- lations was not practicable and, therefore, promulgated immediately effective “interim final regulations”. 41 Fed. Reg. at 48088. The Act also authorizes EPA to establish effluent limitations implementing the second-stage requirement of the Act, best avail- able technology economically achievable. See E. I. du Pont de Nemours & Co. V. Train, 430 U.S. 112, 121 (1977). EPA decided to propose those regulations separately and at a later date. 41 Fed. Reg. at 48091. 4 Petitions for review of the interim final regulations were filed in the United States Court of Appeals for the First Circuit by BASF Wyandotte Corporation and five other companies on January 24, 1977. Subsequently filed petitions for review were transferred to that court. Eli Lilly did not file a petition for review of the interim final regulations. EPA solicited comments on the interim final regula- tions. 41 Fed. Reg. at 48088. Comments on the interim final regulations were filed by a number of persons, in- cluding various manufacturers of pesticides. App. C, infra, 82a. Eli Lilly did not comment on the interim final regulations. On April 25, 1978, EPA promulgated final regula- tions for the Pesticide Chemicals Manufacturing Point Source Category. 43 Fed. Reg. 17775.? On July 18, 1978, Eli Lilly filed a petition for review of the final regula- tions in the United States Court of Appeals for the Seventh Circuit. The petition was thereafter transferred to the United States Court of Appeals for the First Circuit. Both the interim final and the final regulations estab- lished effluent limitations on the discharge of pesticide chemicals, five-day biochemical oxygen demand (“BOD,”), and chemical oxygen demand (“COD”). The effluent limitations are expressed in terms of pounds of pollutants discharged for each thousand pounds of pesticide chemi- cal manufactured (“Ibs./1000 lbs.”) and its metric equivalent (“kg./kkg.”). Both a daily maximum dis- charge level and a maximum average discharge level over a 30-day period are specified. 2 The final regulations were amended subsequently to limit the ap- plication of the effluent limitations for the discharge of pesticide chemicals to 49 specified pesticides. 43 Fed. Reg. 44845 ( -pt. 29, 1978). 0 —————eEE—E———— Te SO a ey ere eee 5 The interim final regulations established effluent limi- tations for three separate subcategories of facilities pro- ducing organic pesticides: halogenated organic pesticides (Subcategory A), organo-phosphorous pesticides (Sub- category B), and organo-nitrogen pesticides (Subcate- gory C). Significantly different effluent limitations were prescribed for each subcategory,* and different data were used in deriving the effluent limitations for each subcate- gory. 41 Fed. Reg. at 48089-90. Eli Lilly manufactures an organo-nitrogen pesticide, trifluralin, at its Lafayette, Indiana plant.‘ The final regulations collapsed the separate effluent limitations for the three categories into a single subca- tegory of organic pesticides and established a uniform set of effluent limitations for all organic pesticides. 40 C.F.R. § 455.22, App. C, infra, 105a. The final effluent limitations for the collapsed subcate- gory of organic pesticides are substantially more strin- gent pel the effluent limitations established by the in- terim final regulations for organo-nitrogen pesticides, in- cluding trifluralin: nosis Interim Final Final (41 Fed. Reg. at 48090) (40 C.F.R. § 455.22, App. C, infra, 105a) 30-Day Average Daily Maximum 30-Day Average Daily Maximum Pesticides 0.0071 Ibs./1000 Ibs. 0.016 Ibs./1000 Ibs. 0.0018 Ibs./1000 Ibs. 0.01 Ibs./1000Ibs. BOD. 8.6 Ibs. /1000 Ibs. 15.1 Ibs./1000 Ibs. 1.4 Ibs. /1000 Ibs. 7.4 Ibs./1000 Ibs. coD 21.1 Ibs./1000 Ibs. 80.4 Ibs./1000 Ibs. 9.0 Ibs./1000 Ibs. 18.0 Ibs./1000 Ibs. 3 80-Day Average coD BOD5 Pesticides Halogenated Organic 21.2 Ibs./1000 Ibs. 8.7 Ibs./1000 Ibs. 0.0031 Ibs./1000 Ibs. Organo-Phosphorus 11.9 Ibs./1000 Ibs. 1.5 Ibs./1000 Ibs. 0.0018 Ibs./1000 Ibs. Organo-Nitrogen 21.1 Ibs./1000 Ibs. 8.6 Ibs./1000 Ibs. 0.0071 Ibs./1000 Ibs. (41 Fed. Reg. at 48089-90) * Trifluralin is the only one of the 49 pesticides covered by the amended regulations which is produced by Eli Lilly. See Note 2, supra. 6 The data used in deriving the final effluent limita- tions for the collapsed subcategory were different from those used to derive the interim final effluent limitations for the organo-nitrogen pesticide subcategory. In the preamble and appendix to the final regulations, EPA described the “major changes” in the regulations and the “expanded data base” upon which those major changes were premised. App. C, infra, 63a-67a, 87a-89a. One of the major changes described was the collapsing of the organic pesticide subcategories. EPA stated that the revisions to the regulations, including the elimination of subcategories, were based on the expanded data base and the Agency’s reexamination of the data. App. C, infra, 64a. EPA further stated that the decision not to differentiate among different organic pesticides and to eliminate the interim subcategories was based on new data indicating that the “quantities of pollutants in the effluents of those plants with the properly operated model technologies installed were similar regardless of the or- ganic pesticide chemicals manufactured” and that “the waste waters of all organic pesticide chemicals can be treated or controlled to the levels documented in the Agency’s data base.” App. C, infra, 64a. No opportunity was afforded for comment on the major changes in the final regulations or on the new data on which those changes were based. Petitioners argued in the Court of Appeals that EPA should have issued notice for public comment on the proposed re- visions, on the rationale for the revisions, and on the new, expanded data base said to support the revised regulations. Eli Lilly argued that it had not commented on the interim final regulations or filed a petition for review of those regulations because it considered them reasonable as applied to its only pesticide manufactur- ing plant at Lafayette, Indiana; thus, Eli Lilly contended that, by making the final regulations substantially more 7 » stringent without notice to allow public comment, EPA deprived Eli Lilly of an opportunity to comment on the regulations and the basis for those regulations. In its decision the court of appeals stated the following principle to be applied in determining whether EPA had complied with the Administrative Procedure Act (“APA”) : Even substantial changes in the original plan may be made so long as they are “in character with the or- iginal scheme” and “a logical outgrowth” of the notice and comment already given. [598 F.2d at 642; App. A, infra, 7a (citation omitted) .] The court held that the “essential inquiry is whether the commenters have had a fair opportunity to present their views on the contents of the final plan” and whether, “given a new opportunity to comment, commenters would not have their first occasion to offer new and different criticisms which the Agency might find convincing’. Id. at 642; App. A, infra, 7a-8a (footnote and citation omitted). The court of appeals first dealt with EPA’s deter- mination to combine the three interim final subcate- gories for organic pesticides into a single subcategory. The court noted EPA had acted contrary to industry comments, which had criticized the interim final regula- tions and which had urged EPA to expand the number of subcategories. Jd. at 643; App. A, infra, 9a. The court reasoned that it “should be clear to commenters when they criticize a regulatory scheme that if the agency accepts those criticisms, a new scheme will be substituted” and the “commenters cannot claim they had no notice to propose and discuss alternatives”. Id. at 643; App. A, infra, 9a-10a. “[T]hough EPA’s solution was not the one for which industry argued, it was suggested by and, in part, a logical outgrowth of industry’s com- ments.” Jd. at 648; App. A, infra, 10a. Therefore, the court concluded that EPA was not required to give notice Ee ee ea’ 8 of the decision to eliminate subcategories for organic pesticides and the industry was not entitled to comment thereon. “For the same reasons,” the court of appeals rejected the contention that EPA should have allowed further opportunity to comment on its determination that all pesticides can be treated to a single level because the possibility of that determination had been “clearly sig- nalled in the interim regulations” since the “industry’s comments plainly suggested that treatability ought to be taken into account.” Id. at 644; App. A, infra, lla (foot- note omitted). Therefore, the court concluded that EPA was not required to permit comment on its determina- tion or on the data and assumptions underlying that determination. The court of appeals also upheld EPA’s failure to allow comment on the new data relied upon by EPA and on the inferences from those data which led EPA to make major changes in the regulations: We must decide whether using new data that re- duced the effluent limits for many of the producers deprived the public of a fair opportunity to present views on the final data base. If the data used and disclosed for the interim regulations presented the issues for comment, then there is no need to seek new comment even though significant quantitative differ- ences result. [Id. at 645; App. A, infra, 138a.] The court concluded that the disclosure of information with the interim final regulations permitted the industry to comment “on the importance of different processes, products, and volumes” and “to collect data at their own plants, analyze it, and submit it to EPA.” Id. at 645; App. A, infra, 14a. “[Wle think it was far more im- portant for EPA to solicit comments on how it intended to collect and use data than on the data itself”. Jd. at 645; App. A, infra, 15a. Therefore, the court concluded that EPA’s reliance on the new data did not require the issuance of a further notice for public comment. ~ - me - I at en. ht nt - Ne nee ee ee te - 9 In reviewing the regulations and the determinations underlying the regulations, the court of appeals deferred to the expertise of the Agency and imposed a “heavy burden” on petitioners of persuading the court that EPA had erred. Id. at 649-50, 652; App. A, infra, 28a-24a, 28a. In the absence of an agency determination during the rulemaking process on issues raised by the petitioners, the court of appeals conducted its own review of the rec- ord or assumed that EPA had given appropriate con- sideration to the matter. Id. at 649, 656 nn. 34, 35 & 37; App. A, infra, 22a; 37a nn. 34 & 35, 38a-39a n. 37. REASONS FOR GRANTING THE PETITION I. THE ISSUES PRESENTED TO THIS COURT ARE IMPORTANT ISSUES WHICH SHOULD BE RE- SOLVED BY THE COURT TO PROVIDE GUIDANCE TO THE COURTS OF APPEALS AND TO THE ADMINISTRATIVE AGENCIES. This case raises important issues which have not pre- viously been addressed by this Court and the resolution of which is necessary in order to provide guidance to the courts of appeals and to the administrative agencies. The courts of appeals have had to deal increasingly with the notice-and-comment requirements of the APA. See, e.g., National Crushed Stone Association v. Environ- mental Protection Agency, 601 F.2d 111 (4th Cir. 1979) ; Weyerhaeuser Corp. v. Costle, 590 F.2d 1011 (D.C. Cir. 1978); United States v. Nova Scotia Food Products Corp., 568 F.2d 240 (2d Cir. 1977) ; American Iron and Steel Institute v. Environmental Protection Agency, 568 F.2d 284 (3d Cir. 1977) ; American Frozen Food Institute v. Train, 539 F.2d 107 (D.C. Cir. 1976). There is a high degree of probability that the issue will arise even more frequently in the future. For ex- ample, pursuant to an amended Consent Decree entered by the United States District Court for the District of | 10 Columbia, EPA is obligated to promulgate regulations establishing effluent limitations and other requirements for thirty-four major industries by May 1981. Natural Resources Defense Council v. Costle, 12 E.R.C. 1833 (D.D.C. 1979), appeal docketed, No. 79-1478 (D.C. Cir. May 9, 1979). In implementing that obligation, the Agency has initiated the practice of proposing regulations which broadly suggest that it will consider alternatives to the proposal and which clearly indicate that it will compile additional information prior to promulgating final regulations. See 44 Fed. Reg. 38745, 38764, 38765, 38766 (July 2, 1979) (proposed regulations for the leather tanning industry). This Court should resolve the conflict among the courts of appeals and provide guidance to the Agency and the courts of appeals as to the Agen- cy’s obligation under the APA to issue notice for public comment on substantially revised regulations based on new or additional data and to the courts of appeals on the appropriate role of the reviewing court when regulations are based in part on such new data. II. THE FIRST CIRCUIT’S DETERMINATION THAT THE ADMINISTRATOR COMPLIED WITH THE NOTICE-AND-COMMENT REQUIREMENT OF THE APA CONFLICTS WITH THE DECISIONS OF OTHER COURTS OF APPEALS AND IS INCOR- RECT. A. The Regulations Were Substantially Changed on _ the Basis of New Data. The final regulations for the single, collapsed organic pesticide subeategory are substantially more stringent than the interim final regulations for the organo-nitrogen pesticide subcategory and are premised on an expanded and different data base. The percentage by which the interim final regulations as applied to waste water from the manufacture of trifluralin and other organo-nitrogen pesticides were reduced is shown in the following table: il Reduction in E fluent Limitations From Interim Final to Final Regulations 30-Day Average Daily Maximum Pesticides —75 percent —47 percent BOD, — 84 percent —51 percent COD —57 percent —57 percent These major changes in the interim final effluent limi- tations were premised on an “expanded data base” (App. C, infra, 64a, 67a) and EPA’s “reexamination” of the regulations in light of that expanded data base (App. C, infra, 87a-88a). As noted by the court of appeals, the expanded data base resulting from EPA’s “further re- search” was the justification for EPA’s critical determi- nation that the waste waters of all pesticide plants can be treated to the same level, for EPA’s elimination of the interim final subcategories for organic pesticides, and for EPA’s reduction of the effluent limitations. 598 F.2d at 643; App. A, infra, 9a. A particularly important basis for the EPA determination was data collected on existing carbon treatment plants by the Agency’s con- tractor, ESE, after promulgation of the interim final regulations. As emphasized by the First Circuit, “[i]f ESE’s work is not reliable, then the final limitations can- not stand’. Id. at 646; App. A, infra, 16a. EPA also relied on its new examination of literature on treatment by carbon adsorption and hydrolysis,’ on laboratory stu- dies conducted by ESE, and on other data compiled and evaluations made subsequent to the publication of the interim final regulations. EPA did not issue public notice inviting comment on the expanded data base for the 5 These twc types of treatment were identified by EPA as the technologies whose use would allow the effluent limitations for pesticides to be met. Jd. at 651; App. A, infra, 28a. The court of appeals’ opinion includes a description of these technologies. Jd. at 651; App. A, infra, 27a-28a. 12 substantially revised regulations. It simply promulgated final revised regulations relying on that expanded data base. In deciding that the Administrator had complied with the APA, the court of appeals cited its prior decision in South Terminal Corp. v. Environmental Protection Agency, 504 F.2d 646 (1st Cir. 1974). At issue in South Terminal were the EPA regulations for attaining the Clean Air Act’s national ambient air quality stand- ards in Boston by reducing vehicular traffic. The notice of proposed rulemaking included specific measures for achieving that goal. The notice also stated that alterna- tives were being considered and identified certain alterna- tives. Id. at 657. The final regulations adopted alterna- tives, including a freeze on the number of parking spzces at Logan Airport and other locations, which had not been identified in the notice of proposed rulemaking. The First Circuit held that the Administrator’s notice of the proposed rules constituted sufficient notice to support his ultimate decision to adopt a different approach because the “notice left no doubt that EPA would consider all reasonable alternatives for cutting down vehicle use.” Id. at 659. Thus, under the First Circuit’s decision in South Terminal, a commenter which knew or should have known that the agency will consider alternatives to the initial proposal is not entitled to notice of or to comment on the alternatives finally selected no matter how much the alternative differs from the proposal. The court of appeals in this case applied the principle developed in South Terminal in holding that interested persons should have anticipated that criticisms of the EPA’s interim final subcategories could lead to the al- ternative of eliminating subcategories even though EPA never disclosed an intent to consider that alternative. The First Circuit extended the rationale of Sowth Termi- nal by holding that interested persons are not entitled to notice of and an opportunity to comment on the new data relied upon by EPA in establishing the final regula- a ee acl gt ech ORR Aa AE ce te teal de GE ADR SARI aah ——EEEE 13 tions if the data disclosed with a proposed (or interim final) regulation reveal the general issues as to the use of data and provide sufficient information for com- menters to generate additional data for submission and use by the agency. B. The Decision Is In Conflict With Decisions of the Courts of Appeals for the Second, Fourth, and District of Columbia Circuits. The First Circuit’s decision conflicts with National Crushed Stone Association v. Environmental Protection Agency, 601 F.2d 111 (4th Cir. 1979), Weyerhaeuser Corp. v. Costle, 590 F.2d 1011 (D.C. Cir. 1978), and United States v. Nova Scotia Food Products Corp., 568 F.2d 240 (2d Cir. 1977), insofar as it holds that EPA was not required to issue notice and allow public comment on substantially revised regulations based on new data and information.® In National Crushed Stone, the Agency had modified the interim final regulations for crushed stone and con- struction sand and gravel facilities by increasing the 30- day average effluent limitation for total suspended solids (“TSS”) and by adding a maximum daily effluent limita- tion for TSS. 601 F.2d at 115. The changes were made on the basis of data collected by the Agency’s contractor (Versar) on which there was no opportunity for public comment. Jd. at 117. The Fourth Circuit held: The objections go on and on, but enough have been related to show that they are far from frivolous, and while EPA will undoubtedly take issue with the report of [the petitioners’] engineer, we need not, and do not, decide whether the objections raised in the engineer’s report are valid. What we do decide 6 The First Circuit’s decision also is contrary to a Ninth Circuit decision on an analogous issue. See Marathon Oil Co. v. Environ- mental Protection Agency, 564 F.2d 1253, 1271 (9th Cir. 1977). 14 is that the mistakes in the use of the Versar data, if any mistakes there were, were shown by the report to be of possible significance in the formulation of the final regulations. ... The fact that the petitioners, and just as importantly the public, had no opportun- ity to comment on the use of the Versar data prior to the promulgation of the final regulations in the face - of serious questions concerning the validity of their use is reason to remand the regulations for further consideration. ]Jd. at 119 (footnote omitted).] In direct contrast, the First Circuit held that the APA is satisfied if the notice informs the public of the general issues relating to data use and provides the framework for the affected industry to generate data for submission to EPA. Under the First Circuit’s rule, no obligation is imposed on the Agency to permit public comment on its new or expanded data base. In Weyerhaeuser, EPA secured new data after issu- ing the interim final effluent regulations and after the close of the public comment period. 590 F.2d at 1029. Using that data, it recalculated the biochemical oxygen demand (BOD) effluent limitation for acetate grade dis- solving sulfate pulp mills for inclusion in the final effluent regulations which were the subject of the peti- tions for review. Jd. at 1029. The court held that the Agency’s procedures “improperly denied petitioners the opportunity to comment on a significant part of the Agency’s decisionmaking process as required by Section 553” because the “figures variously relied upon by the Agency must be validated, if at all, by reference... to certain data . . . obtained by the Agency after the op- portunity for public comment had lapsed... .” Id. at 1030-31 (citations omitted). The court of appeals stated that the data which “were not subject to prepromul- gation public scrutiny are factual matters. As such, they are especially subject to verification through the notice 15 and comment process and less acceptably removed there- from.” Id. at 1030 n. 26. The District of Columbia Circuit’s decision in Weyer- haeuser follows its prior decision in Portland Cement Association v. Ruckelshaus, 486 F.2d 375 (D.C. Cir. 1973), cert. denied, 417 U.S. 921 (1974). In Portland Cement, the court of appeals found “a critical defect in the decisionmaking process in arriving at the standard under review in the initial inability of petitioners to obtain—in timely fashion—the test results and procedures used on existing plants which formed a partial basis for the emission control level adopted” in the standard of performance for new portland cement plants. 486 F.2d at 392. The court concluded: It is not consonant with the purpose of a rule- making proceeding to promulgate rules on the basis of inadequate data, or on data, that, [in] critical de- gree, is known only to the agency. [J/d. at 393.] In direct contrast, the First Circuit held that inviting comments on new data used by the Agency in establish- ing revised final regulations is unimportant. The First Circuit attempted to distinguish Weyerhaeuser on the ground that the formula used by EPA to calculate the effluent limitations in that case was not set forth or explained in the record. 598 F.2d at 646 n. 15; App. A, infra, 15a n. 15. However, the District of Columbia Cir- cuit clearly held that an opportunity for public comment on the data was required by the APA and that the fact that the calculations were not reflected in the record con- stituted additional grounds for remand. In Nova Scotia Food Products, interested persons “were not informed of the scientific data, or at least a selection of such data deemed important” by the Food and Drug Administration in establishing processing standards for fish products. 568 F.2d at 251. In holding that the notice 16 of proposed rulemaking was deficient under the APA for failure to disclose such scientific information, the Second Circuit found: Scientific research is sometimes rejected for diverse inadequacies in methodology; and statistical results are sometimes rebutted because of a lack of ade- quate gathering technique or of supportable extra- polation. Such is the stuff of scientific debate. To suppress meaningful comment by failure to dis- close the basic data relied upon is akin to rejecting comment altogether. [568 F.2d at 252 (emphasis added) .] The First Circuit here recognized that the issues posed difficult scientific questions, including those related to the validity of the critical ESE data. The court knew it could not “play the role of Superchemist” to resolve those issues. 598 F.2d at 649; App. A, infra, 23a. None- theless, the court held that notice and comment were not required on fundamental scientific and technical issues relating to the new data relied upon by EPA. C. The First Circuit Erred in Deciding that EPA Had Complied With The APA. There is substantial agreement among the courts of appeals that regulations are not necessarily legally de- fective if they differ, even substantially, from the regu- latory proposal published for public comment. See, e.g., South Terminal Corp., 504 F.2d at 659; International Harvester Co. v. Ruckelshaus, 478 F.2d 615, 682 (D.C. Cir. 1973); California Citizens Band Association v. United States, 375 F.2d 48, 48 (9th Cir.), cert. denied, 389 U.S. 844 (1967). However, no other case invoking the notice-and-comment issue has concerned a change in regulations which appears comparable in magnitude to the 50 to 85 percent reduction in allowable discharges from organo-nitrogen pesticide manufacturing plants as occurred in this case. The substantiality of the modifi- et 17 cation of a regulation must be a factor to be considered in applying the APA. The First Circuit erred in failing to consider that factor. The First Cireuit construed the APA as not requiring notice for comment prior to adoption as a final regulation of an alternative that is radically different from the pro- posed regulation as long as the Agency indicates in the initial notice that it will consider all possible alternatives. Such an interpretation provides an agency with an un- limited opportunity to preclude public comment by the simple expedient of issuing a “comprehensive notice” that it is considering all possible alternatives to its pro- posal. See South Terminal Corp., 504 F.2d at 659. Most importantly, the First Circuit’s decision in this case obviates the purpose and function of the notice-and- comment requirements of the APA. This Court has not had occasion to provide specific guidance on the legisla- tive purpose of the notice-and-comment requirement. The courts of appeals, however, have identified three important functions of Section 4. First, the notice allows interested parties an opportunity to offer informed criti- cism and comments. See, e.g., Ethyl Corp. v. Environ- mental Protection Agency, 541 F.2d 1, 48 (D.C. Cir. 1976), cert. denied, 426 U.S. 941 (1976); Portland Ce- ment Association, 486 F.2d at 392-94. Second, giving interested persons a meaningful opportunity to comment enables the Agency promulgating the rules “to educate itself before establishing rules and procedures which have a substantial impact on those regulated”. Texaco, Ine. v. Federal Power Commission, 412 F.2d 740, 744 (8d Cir. 1969). Third, the dialogue of comment and agency response to comment assists the reviewing court in deciding difficult issues. Home Box Office, Inc. v. Federal Communications Commission, 567 F.2d 9, 35-36 (D.C. Cir. 1977) ; see Weyerhaeuser Corp., 590 F.2d at 1028; 18 cf. Marathon Oil, 564 F.2d at 1271 n. 54. (“[C]omment is often an invaluable source of information to a review- ing court attempting to evaluate complex statistical and technological decisions.’’) The decision of the First Circuit in this case is not consistent with those objectives. The First Circuit per- ceived the principle role of industry member comment as narrowly confined to providing the Agency with addi- tional information and data on their plants in order to provide the Agency with the broadest possible data base. The First Circuit considered it far less important, and not sufficiently important to require further notice for comment, that the industry and other interested persons comment on the data compiled by the Agency (including the validity of that data) or on the Agency’s scientific and technical inferences from the data. As a result, the First Circuit’s decision unnecessarily cribs the scope of the subject matter which should be subject to informed criticism and comment. The First Circuit assumes that the Agency is not in need of and would not benefit from the education result- ing from comment, favorable or critical, on the data be- fore it and the conclusions which reasonably can be drawn from that data. Finally, the First Circuit’s decision deprives a review- ing court of a balanced and complete record upon which to assess sometimes difficult and complex issues. This latter point is demonstrated dramatically in this case by the difficulty which the First Circuit had in resolving the issues before it and by its unique and inappropriate ap- proaches toward resolving these issues on the basis of an administrative record which had not been subject to public scrutiny and comment. See pages 22-27 infra. 19 D. Eli Lilly is Particularly Harmed By The First Circuit’s Ruling. The First Circuit’s decision applies with particular inequity to Eli Lilly. Eli Lilly’s concern was for a single pesticide, trifluralin. Upon review of the interim final effluent limitations, Eli Lilly concluded that they were reasonable as applied to the production of trifluralin at its Lafayette, Indiana plant. Eli Lilly was not in a posi- tion to comment on whether the interim final regulations were reasonable or unreasonable for the industry as a whole or as applied to the production of pesticides by other manufacturers in a diverse industry. Therefore, Eli Lilly did not file comments on the interim final regu- lations or a petition for review of the interim final regulations. Although those facts specific to Eli Lilly were set forth for the First Circuit, the court of appeals did not spe- cifically address them.’ By necessary implication, the First Circuit held that the interim final regulations con- stituted sufficient notice of the final regulations to permit Eli Lilly an adequate opportunity to participate in the rulemaking for the same reasons that it concluded that those who did comment and criticize the interim final regulations had sufficient notice of the possible outcome of their comments: “The commenters cannot claim they had no notice to propose and discuss alternatives.” 598 F.2d at 648; App. A, infra, 10a. It is unreason- 7 The court did state that “[rJegulatory targets have no guaran- tee that proposed effluent limits, which they are capable of meeting, will stay the same.” 598 F.2d at 646; App. A, infra, 15a. The issue, however is not whether Eli Lilly could rest in complete assurance that the effluent limitations applicable to its plant would remain the same. Rather the issue is whether, under the procedures adopted by the Agency, Eli Lilly was accorded the opportunity to participate in the rulemaking required by the APA. 8 Any suggestion that Eli Lilly should have recognized that the Agency might collapse the subcategories because one commenter, as the court of appeals read its remarks, saw that possibility would be unreasonable and contrary to the Third Circuit’s decision in Wagner Elec. Corp. v. Volpe, 466 F.2d 1018, 1019 (3d Cir. 1972). 20 able to expect that Eli Lilly should have hypothesized alternative schemes which EPA might adopt to the de- triment of Eli Lilly; that Eli Lilly should have sub- mitted comments in opposition to those schemes; or that Eli Lilly should have developed alternative approaches to the interim final subcategories which would result in reasonable effluent limitations for trifluralin. Most importantly, however, the First Circuit’s decision deprived Eli Lilly of the opportunity to comment on the determination which had an adverse impact on Eli Lilly —the determination based on an expanded data base to collapse the three interim final subcategories into one subeategory and dramatically reduce the effluent limita- tions for trifluralin. In short, according to the court of appeals’ theory, Eli Lilly was obligated to assume that the Agency would alter its course in a manner contrary to Eli Lilly’s interests and to comment accordingly on in- terim final regulations to which it did not object. But Eli Lilly was not entitled to comment on the changes in methodology, assumptions, or data which were the basis for the final regulations which Eli Lilly did find unrea- sonable and objectionable.® ® The fact that data from Eli Lilly’s plant was part of the Agen- cy’s expanded data base tends to reinforce the conclusion that the First Circuit has unjustifiably narrowed the notice-and-comment requirements of the APA. Eli Lilly operates a carbon treatment system for waste water from its trifluralin process. At EPA’s re- quest, ESE sampled the waste water going to Eli Lilly’s ..rbon treatment system and the treated effluent from the carbon treatment system in January 1977. Eli Lilly believed that carbon treatment was being considered by EPA as a basis for the second-stage regu- lations implementing requirements for best available technology and that the information was being collected for the purpose of prepar- ing such proposed regulations. See note 1 supra. In announcing the interim final regulations, EPA “emphasized” that it planned to issue “in the near future” second-stage regulations which would require ‘substantial further reductions in pollutants discharged” by the use of “advanced technology.” 41 Fed. Reg. at 48091. One of the advanced technologies cited was carbon adsorption. 7d. at 48091. [Footnote continued on page 21] Oe he IATA 21 ® [Continued ] At no time did EPA inform Eli Lilly that the ESE data would be used in the final first-stage regulations or would be cited as evidence that substantially reduced first-stage limitations were attainable because, on their face, the data indicated that Eli Lilly’s discharge of pesticides is below the level permitted by the final effluent limitations. Eli Lilly was afforded only a limited opportunity to comment on the ESE numbers and no opportunity to comment on EPA’s inter- pretation and use of the data. The ESE data were furwarded to Eli Lilly and Eli Lilly, noting the differences between its analytical results and ESE’s, suggested further dialegue on the analytical validity of the survey data. The invitation was not accepted and the matter remained unresolved when the final regulations were promulgated. Eli Lilly argued in the court of appeals (1) that the ESE data should not have been used because of their possible analytical in- validity; (2) that data from a survey covering the first four days of a seven-day treatment cycle of a new carbon treatment system should not have been cited as representing consistent, long-term performance of the treatment system; and (3) that, because ESE’s survey conducted in accordance with EPA’s request, covered only treated effluent from the carbon system and did not include certain waste streams which bypassed the carbon system, the ESE data did not demonstrate that Eli Lilly could achieve the final effluent limitations. The First Circuit rejected these arguments in large part because it found the record to be ambiguous and without sup- port for them. Jd. at 648, 653; App. A, infra, 20a, 3la. Had EPA issued a further notice for public comment on the revised regula- tions and on the expanded data base, Eli Lilly could have provided further information on the analytical invalidity of the data and would have had its first opportunity to comment on EPA’s interpre- tation and use of that data. ne ee ae ae deren mannan an Reh en SS a — ——— 22 Ill. EVEN IF IT WERE ASSUMED THAT EPA WAS NOT REQUIRED TO ISSUE NOTICE FOR PUBLIC COMMENT ON THE REVISED REGULATIONS, THE COURT OF APPEALS’ DECISION TO DEFER TO EPA’S DETERMINATIONS BASED ON AN EX- PANDED DATA BASE WAS INCORRECT AND IN CONFLICT WITH THE DECISION OF ANOTHER COURT OF APPEALS AND RESULTED IN THE COURT SUBSTITUTING ITS JUDGMENT FOR THAT OF EPA. A. The Court of Appeals Deferred to EPA on Matters Not Subject to Public Comment, and Conducted a De Novo Review of New Data and Information. The First Circuit recognized that the notice-and-com- ment requirements are linked to the standard to be applied in reviewing the Agency’s action because that requirement “supports the assumption we make with regard to EPA’s substantive decisions that those decisions are in fact the product of informed, expert reasoning tested by exposure to diverse public comment.” 598 F.2d at 641; App. A, infra, 6a. The court stated: We will not remand [to the Agency] so long as the Agency has explained the facts and policies on which it relied; the facts have some basis in the record; and a reasonable person could make the judgment the Agency made. [J/d. at 652; App. A, infra, 28a.] The court held, erroneously, that interested persons had an opportunity to comment on alternative sub- categorization schemes that EPA might adopt. The court of appeals did not, and could not, suggest that the expanded data base upon which EPA relied and the tech- nical and scientific inferences which it drew from those data were “tested by exposure to diverse public com- ment.” Nonetheless, the court deferred to determina- tions made by EPA which were based on such untested data and inferences. SPAR AMES ih 13 2. ASAIO BZ 0s) SBS Ltey a 23 The following are illustrative of the court’s deference to EPA: Petitioners argued that, at best, EPA had data on only a few of the forty-nine pesticides covered by the regulations (see note 2 supra) and, therefore, could not reach the critical conclusior that all pesticides can be treated to the same level. Noting that EPA’s expanded data base included technical literature references on the treatment of pesticides, the court deferred to EPA’s judgment, stating: ; [T]he Agency is entitled to use its chemical exper- tise to conclude that compounds’ manufacturing proc- esses, chemical structures, and physical properties are sufficiently related so that if one is treatable the others are likely to be as well.... We conclude... that the Agency permissibly decided that the tech- niques are broadly applicable to facilities manufac- turing the 49 pesticides discharge of which is regu- lated. [598 F.2d at 656; App. A, 36a-37a. (foot- note and paragraphing omitted).] The court rejected petitioners’ arguments that EPA erred in inferring from the literature, particularly literature on laboratory studies, the result which could be achieved by full scale treatment systems. The court responded that it is “up to the Agency experts to decide whether relaxing the laboratory conditions would so change the result that the pesticide could not be treated by industry.” Id. at 652 n. 27; App. A, infra, 29a-30a n. 27. Most astonish- ing, the court of appeals conceded that it could find “no mention” in the expanded data base or EPA’s evaluation of that data base of ten of the forty-nine regulated pesti- cides, but was “willing to assume from EPA’s general language that it reached a similar conclusion as to these ten pesticides as well.” Jd. at 656 n. 34; App. A, infra, 37a n. 34 (emphasis added) .’® 1 The court of appeals made a number of additional ‘“assump- tions” that EPA had properly applied its expertise in evaluating and using the information before it. See id. at 656-57 nn. 35 & 37; App. A, infra, 37a n. 35, 38a-39a n. 37. iii 24 Petitioners challenged the validity of the data collected by EPA’s contractor, ESE. The court of appeals con- cluded that “[i]Jf ESE’s work is not reliable, then the final limitations cannot stand.” Jd. at 646; App. A, infra, 16a. The ESE data, and particularly the labora- tory documents from which their validity must be as- sessed, were not made available for public review during the rulemaking." The court of appeals found EPA’s response in its brief and supplemental memorandum to be an inadequate response to petitioners’ arguments. Rather than remand the regulations, the court adopted a new and unique approach toward reviewing agency action: “We have therefore conducted our own review.” Id. at 649; App. A, infra, 22a. The court conceded that its independent review was “necessarily superficial” and inconclusive: We cannot be sure that these references [to the ESE records] are an adequate response to criti- cisms levied at ESE’s general control procedures. But we cannot play the role of Superchemist. Peti- tioners bear an extremely heavy burden if they desire to demonstrate that the results of a rulemaking pro- cedure are infested with fatal flaws of laboratory practice. Our review, partial and facial though it is, satisfies us of the probability that EPA was jus- tified in basing its regulations on ESE’s work. [Jd. at 649-50; App. A, infra, 23a-24a (footnote omit- ted) .] B. The First Circuit Erred in According Judicial Deference to EPA Determinations Based on Data and Information Which Had Not Been Tested By Public Comment. The First Circuit’s decision conflicts with the District of Columbia Circuit’s decision in Weyerhaeuser Corp. V. 11 Indeed, a complete set of laboratory documents was not turned over to EPA or petitioners by ESE until after oral argument before the First Circuit. Jd. at 646; App. A, infra, 16a. i i 3 4 v3 # be ; 25 Costle, 590 F.2d 1011 (1978). The First Circuit cited Weyerhaeuser in support of the standard of review to be applied. 598 F.2d at 647; App. A, infra, 18a-19a. How- ever, the First Circuit declined, without explanation, to follow the rule in Weyerhaeuser that an agency determi- nation is not entitled to a presumption of rationality when the data upon which that determination is based have not been subject to public scrutiny. The court in Weyerhaeuser stated: This denial of an opportunity for comment on these facts further undermines our usual assumption that notice and comment rulemaking, by virtue of its ac- cessibility to public scrutiny, achieve rational re- sults. 27... [I]t is our place only to review actions actually and properly taken by the Agency. If that action is improper and if we cannot be sure that un- der correct procedures the Agency would have reached the same conclusion, we cannot characterize that defect as harmless. [590 F.2d at 1931 & n. 27 (original emphasis) .] The District of Columbia Circuit’s decision in Weyer- haeuser is analogous to this Court’s decision in Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402 (1971). If the reviewing court determined that the explanation accompanying the initial agency decision was deficient, this Court suggested that the reviewing court require the agency to prepare additional findings explaining the basis for its action. The Court recognized that such findings would be prepared outside the normal course of agency proceedings and cautioned that they should not be ac- corded the usual deference: the findings “will, to some extent, be ‘post hoc rationalizations’ and thus must be reviewed critically”. 401 U.S. at 421. 26 C. The First Circuit Impermissibly Substituted Its Judgment for That of the Agency. On a number of occasions, this Court has emphasized that a reviewing court may not substitute its judgment for the judgment of the agency whose action is under review. Bowman Transportation, Inc. v. Arkansas-Best Freight Systems, Inc., 419 U.S. 281, 285 (1974); Fed- eral Trade Commission v. Sperry & Hutchinson Co., 405 U.S. 233, 249 (1972) ; Citizens to Preserve Overton Park, 401 U.S. at 416. The First Circuit was propelled into that forbidden role by its decision to review the regulations on the basis of a record incompletely tested by exposure to public comment and often devoid of EPA response to the com- ments which would have been made. The court made “assumptions” that EPA had ration- ally resolved issues raised by petitioners when there was no evidence in the record that EPA had even considered the issues. The court conducted an unprecedented inde- pendent review of laboratory documents which EPA did not receive until after it had promulgated the final regulations. Even then, the court failed to reach a defini- tive conclusion as to the validity of the critical laboratory data. Yet, it upheld EPA’s use of the data on the ground that petitioners had not carried their heavy burden of persuading the court that EPA had acted impermissibly.” EPA did not reach a judgment that data supported by its contractor, ESE, were reliable. The court of appeals made that judgment after a “partial! and facial” review. 12The First Circuit’s procedure contrasts with the following cbservation of Judge McGowan: “[T]he realities of judicial scru- tiny . . do not contemplate that the court itself will, by a laborious examination of the record, formulate in the first instance the sig- nificant issues faced by the agency and articulate the rationale of their resolution.” Automotive Parts & Accessories Ass’n. Vv. Boyd, 407 F.2d 330, 338 (D.C. Cir. 1968). Mah icieh, CaS rsearwee: 6? he 27 598 F.2d at 650; App. A, infra, 24a. The court then upheld EPA’s use of the data because the petitioners had not carried their heavy burden of persuading the court that the court’s uncertain conclusion as to the reliability of the ESE data was in error. This Court rejected judicial excursions into the admin- istrative domain in Federal Power Commission v. Trans- continental Gas Pipe Line Corp., 423 U.S. 326 (1976): At least in the absence of substantial justification for doing otherwise, a reviewing court may not after determining that additional evidence is requisite for adequate review, proceed by dictating to the agency the methods, procedures, and time dimension of the needed inquiry and order the results to be reported to the court without opportunity for further con- sideration on the basis of the new evidence by the agency. Such a procedure clearly runs the risk of ‘propel [ling] the court into the domain which Com- gress has set aside exclusively for the administrative agency.’ SEC v. Chenery Corp., 332 U.S. 194, 196 (1947).” [Jd. at 333 (emphasis added and footnote omitted) ; cf. Camp v. Pitts, 411 U.S. 188, 141-43 (1973) .] The First Circuit’s decision amounts to nothing less than the substitution of its own uncertain judgment for that which EPA should have made after notice and op- portunity for comment in accordance with the APA o1 upon remand by the court of appeals. 28 CONCLUSION For the foregoing reasons, Eli Lilly prays that the Court grant this petition for a writ of certiorari to re- view the judgment of the United States Court of Appeals for the First Circuit in this case. Of Counsel: CLEARY, GOTTLIEB, STEEN & HAMILTON 1250 Connecticut Ave., N.W. Washington, D.C. 20036 September 21, 1979 Respectfully submitted, DOUGLAS E. KLIEVER CHARLES F. LETTOW JOHN S. MAGNEY WILLIAM N. HALL 1250 Connecticut Ave., N.W. Washington, D.C. 20036 JOHN C. JENKINS 307 E. McCarty Street Indianapolis, Indiana 46206 Counsel for Petitioner Eli Lilly and Company Appendices - ee ao Ss = ~~ ais : fe spr. Pimp a ee ee waa - > ee ee la APPENDIX A Nos. 77-1042, 77-1059, 77-1085, 77-1153, 78-1417, 78-1428, 78-1454 and 78-1462. UNITED STATES COURT OF APPEALS, FIRST CIRCUIT BASF WYANDOTTE Corp. et al., Petitioners, v. DOUGLAS M. COSTLE, as Administrator, Environmental Protection Agency, Respondent. E. I. pu PONT DE NEMouRS & Co. et al., Petitioners, v. DOUGLAS M. COSTLE, as Administrator, Environmental Protection Agency, Respondent. MONSANTO COMPANY, Petitioner, v. DouGLas M. COSsTLE, as Administrator, Environmental Protection Agency, Respondent. Dow CHEMICAL COMPANY, Petitioner, v. DouGLAs M. COSTLE, as Administrator, Environmental Protection Agency, Respondent. 2a MONSANTO COMPANY, Petitioner, v. DouGLas M. COsTLE, as Administrator, Environmental Protection Agency, Respondent. Dow CHEMICAL COMPANY, Petitioner, V. DouGLas M. COsTLE, as Administrator, Environmental Protection Agency, Respondent. E. I. DU PONT DE NEMOuRS & Co. e¢ al., Petitioners, V. DouGLas M. COSTLE, as Administrator, Environmental Protection Agency, Respondent. ELI LILLY AND COMPANY, Petitioner, V. DouGLas M. COSsTLE, as Administrator, Environmental Protection Agency, Respondent. NATIONAL AGRICULTURAL CHEMICALS ASSOCIATION Intervenor. Argued Jan. 3, 1979 Decided May 7, 1979 a a 8a Douglas E. Kliever, Washington, D.C., with whom Robert C. Barnard, Charles F. Lettow, John S. Magney, and Cleary, Gottlieb, Steer & Hamilton, Washington, D.C., were on brief, for petitioners in Nos. 77-1042, 77-1059, 77-1085, 78-1417, 78-1454, and 78-1462. J. D. Fleming, Jr., Atlanta, Ga., with whom D. Robert Cumming, Jr., John H. Fleming, and Sutherland, Asbill & Brennan, Atlanta, Ga., were on brief, for petitioner in Nos. 77-1153 and 78-1428. Robert L. Ackerly, Washington, D.C., with whom Rich- ard A. Flye, Sellers, Conner & Cuneo, Washington, D.C., and Paul M. Siskind, Boston, Mass., were on brief, for intervenor. Paul M. Kaplow, Atty., Dept. of Justice, and Colburn T. Cherney, Atty., Environmental Protection Agency, with whom James A. Rogers, Associate Gen. Counsel, Steven Schatzow, Deputy Associate Gen. Counsel, En- vironmental Protection Agency, James W. Moorman, Asst. Atty. Gen., and Angus MacBeth, Washington, D.C., were on brief, for respondent. Before COFFIN, Chief Judge, BOWNES, Circuit Judge, MAZZONE,* District Judge. COFFIN, Chief Judge. These consolidated petitions have been brought by eleven manufacturers of pesticides’ against the respon- dent, the Administrator of the Environmental Protection Agency (EPA or Agency), seeking review of regulations governing the discharge of pollutants by the pesticide industry. 40 C.F.R. Part 455, 43 Fed. Reg. 17776 and 43 Fed. Reg. 44845 (1978). An industry organization, * Of the District of Massachusetts, sitting by designation. 1 The petitioners are BASF Wyandotte Corp., Diamond Shamrock Corp., FMC Corp., Olin Corp., American Cyanamid, Union Carbide Corp., E. I. duPont de Nemours & Co., Inc., Ciba-Geigy Corp., Mon- santo Co., Dow Chemical Co., and Eli Lilly and Co. 4a the National Agricultural Chemical Association (NACA), has intervened. The Federal Water Pollution Control Act states as a “national goal that the discharge of pollutants into the navigable waters be eliminated by 1985.” 33 U.S.C. § 1251(a) (1). These regulations are promulgated in respe” se to Congress’ direction that the Administrator provide guidelines for the effluent reduction possible through implementation of the “best practicable control technology currently available’. 33 U.S.C. §§ 1311(b) (1) (A) and 1314(b) (1).? In 1974 the Agency hired an outside contractor, Roy F. Weston, Inc. (Weston), to analyze the industry. Weston submitted its final report in December of 1975. In early 1976 EPA hired a second contractor, Environmental Sci- ence and Engineering, Inc. (ESE), to evaluate Weston’s work. ESE determined that Weston’s work needed im- provement and undertook its own study of the industry. In late 1976 EPA published interim final regulations that were immediately effective, but on which EPA invited public comment. 41 Fed. Reg. 48087 (1976). An interim development document and an economic analysis explain- ing the derivation of the interim regulations were also released. In the months following publication of the interim reg- ulations EPA received comments on many issues raised by the regulations. EPA also collected additional data and conducted further research. In early 1978 the final regulations were published, 43 Fed.Reg. 17776 (1978), as were a final development document and economic anal- ysis. The final regulations differed from the interim regulations in a number of significant ways. The one principally relevant in this case is that EPA finally sub- divided the industry into three subcategories: (1) Or- 2For a more thorough discussion of the statutory framework see Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1019-1021 (D.C. Cir. 1978), and cases cited. : % | 5a ganic Pesticide Chemicals Manufacturing; (2) Metallo- Organic Pesticide Chemicals Manufacturing; and (3) Pesticide Chemicals Formulating and Packaging. In the interim regulations the organic pesticide subcategory had been further divided into three subcategories. For the second and third final subcategories the regulations permit “no discharge of process waste water pollutants into navigable waters.” 40 C.F.R. §§ 455.82 and 455.42. For the first subcategory, 40 C.F.R. § 455.22 limits the pounds or kilograms of chemical oxygen demand (COD), biological oxygen demand (BOD), total suspended solids, and pesticide chemicals that a plant may discharge per thousand pounds or kilograms of pesticide produced dur- ing any one day or any 30 consecutive days. The levels set are lower than the levels set by the interims for some producers and higher for others. Also the pH level (the relative acidity or alkalinity) of the effluent must be within a set range. After the final regulations issued, one of the petitioners filed a motion for reconsideration alleging, among other things, that analytical techniques were not available to detect many pesticides at the levels stated in the regula- tions, EPA reexamined the record and discovered that Some measurement methods that EPA thought were available might not be reliable. Accordingly, EPA amended the regulations so that the pesticide content of process waste water would be limited for the producers of only 49 out of several hundred pesticides. 43 F 44845, 44856 (1978). . sin The first petition for review challenged the interim final regulations. When the final regulations were pub- lished we granted permission to amend so as to include review of the finals. BASF Wyandotte Corp. v. Costle 582 F.2d 108 (1st Cir. 1978). Subsequently the petitions for review filed in other circuits were transferred to this circuit. The consolidated petitions assert several pro- 6a cedural and substantive errors in the regulations and their promulgation. I. Organic Pesticide Manufacturing A. Administrative Procedure Act Compliance Petitioners’ first complaint is that EPA failed to com- ply with the requirements of the Administrative Proce- dure Act in that the final regulations were so different from the interim final regulations that the interims were not notice of “either the terms or substance of the pro- posed rule or a description of the subjects and issues involved.” 5 U.S.C. § 553(b) (3). This requirement is a critical one because it supports the assumption we make with regard to EPA’s substantive decisions that those decisions are in fact the product of informed, expert rea- soning tested by exposure to diverse public comment. Though our review of an agency’s final decision is rela- tively narrow, we must be strict in reviewing an agency’s compliance with procedural rules. See Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1027-1028 (D.C. Cir. 1978). In this case EPA issued interim final regulations and sought comments on them. Industry representatives, gov- ernment agencies, and others submitted voluminous com- ments on many aspects of the interim regulations. It is clear that EPA gave careful consideration to these com- ments. The Agency summarized the public comment, together with the Agency responses in the prologue to the final regulations. 43 Fed. Reg. 17781-85 (1978). The Agency accepted several suggestions made in comments critical of the interim regulations. For instance, EPA deleted some parameters by which the interim regulations controlled discharges,® abandoned use of COD/BOD ratios 3 The interim regulations limited the phenol and ammonia con- tent of discharges from some pesticide production plants. 41 Fed. Reg. 48088 (1976). — Ta to supplement raw waste load data, and tried certain statistical tests proposed by commenters. EPA further demonstrated its openness to comments by eliminating, as we have noted, pesticide discharge limits for all but 49 chemicals in response to information received after the final regulations were printed. The procedural rules were meant to ensure meaningful public participation in agency proceedings, not to be a straitjacket for agencies. An agency’s promulgation of proposed rules is not a’ guarantee that those rules will be changed only in the ways the targets of the rules suggest. “The requirement of submission of a proposed rule for comment does not automatically generate a new oppor- tunity for comment merely because the rule promulgated by the agency differs from the rule it proposed, partly at least in response to submissions.” International Har- vester Co. Vv. Ruckelshaus, 155 U.S.App.D.C. 411, 428, 478 F.2d 615, 632 (1973); Weyerhaeuser Co. v. Costle, supra, at 1031; American Frozen Food Institute v. Train, 176 U.S.App.D.C. 105, 1382, 539 F.2d 107, 134 (1976). Even substantial changes in the original plan may be made so long as they are “in character with the original scheme” and “a logical outgrowth” of the notice and comment already given. South Terminal Corp. v. EPA, 504 F.2d 646, 658, 659 (1st Cir. 1974). The essential inquiry is whether the commenters have had a fair opportunity to present their views on the contents of the final plan.‘ We must be satisfied, in other words, that given a new opportunity to comment, com- 4In the words of the Attorney General’s Manual on the Ad- ministrative Procedure Act (1947), a contemporary explanation of the Act’s purposes and provisions, “the notice should be sufficiently informative to assure interested persons an opportunity to par- ticipate intelligently in the rule making process.” Jd. at 30. Even where the Agency could publish the proposed rule itself, the Manual suggests that it may choose not to, issuing instead “a more general ‘description of the subjects and issues involved.’ ” Jd. at 29. ; | | 8a menters would not have their first occasion to offer new and different criticisms which the Agency might find convincing. Weyerhaeuser, at 1031. Thus, where the final rules “are the result of a complex mix of controver- sial and uncommented upon data and calculation’, re- mand may be in order. 7d. Similarly, where the Agency adds a new pollution control parameter without giving notice of intention to do so or receiving comments, there must be a remand to allow public comment. Amer- ican Frozen Food Institute, supra, 176 U.S.App.D.C. at 133, 5389 F.2d at 135. The question, however, always requires careful consideration on a case-by-case basis. The first and principal change complained of is the Agency’s decision to merge the first three interim sub- eategories® into a single Organic Pesticide Chemicals Manufacturing subcategory.® So far as the record dis- closes, petitioners were not aware of this change until the final regulations were promulgated and the time for comment had expired. EPA consolidated the former sub- categories because it “recognized certain ambiguities were present in its subcategorization based on chemical struc- ture. Many pesticides contain more than one functional group ... and do not fit the former subcategorization scheme.” 43 Fed.Reg. 17777 (1978). Consequently, “and 5The interim regulations included separate subcategories for manufacturers of Halogenated Organic Pesticides, Organo- Phosphorous Pesticides, and Organo-Nitrogen Pesticides. 6 Respondent incorrectly read petitioners’ procedural challenge as being limited to this change. BASF petitioners’ brief clearly states other alleged deficiencies in notice: “EPA should have exposed to public comment its decision to limit the regulations to those pesticides for which there are reliable analytical methods, its decision to adopt a single category for all organic pesticides, its determination that all pesticides can be treated to a single level regardless of differ- ences in treatability of particular pesticides and its assess- ment of the applicability and effectiveness of carbon treatment and hydrolysis.” ras oe ee 9a in response to industry comments”, EPA undertook fur- ther research and found that “the quantities of pollutants in the effluents of those plants with the properly operated model technologies installed were similar regardless of the organic pesticide chemicals manufactured. The Agency . . . therefore concluded that the waste waters of all organic pesticide chemicals can be treated or con- trolled to the levels documented. ... Thus, the final reg- ulations do not differentiate among halogenated organic, organo-phosphorus, or organo-nitrogen pesticide chemi- eals.” Id. The industry comments were almost unanimous in condemning the three original subcategories both for being internally inconsistent and insufficiently differen- tiated from the other categories.’ Comments presented statistical tests of EPA’s data, purporting to show that: the subcategories were not distinguishable from each other. Comments also pointed to the inclusion of very different compounds within particular subcategories. The comments made a strong case against use of the in- terim subcategories, and EPA decided that the criti- cism was persuasive. It follows that EPA had to decide on an alternative unless it was to abandon regula- tion of the pesticide industry. Industry’s preference was clear. They wanted EPA to expand the number of subcategories. They are now aggrieved because EPA accepted their criticism of the original subcategories but chose a different solution, collapsing rather than expand- ting them. Petitioners suggest that EPA’s response took them entirely by surprise and that EPA had somehow indicated that the only issue for comments would be whether three subcategories were enough or there should be more. Neither suggestion is grounds for remand. It should be clear to commenters when they criticize a regulatory 7 See, e.g., comments of Mobay Chemical Corp., App. at 1753. 8 Jd., App. at 1772. 10a scheme that if the agency accepts those criticisms, a new scheme will be substituted. The commenters cannot claim they had no notice to propose and discuss alterna- tives. And in fact they did so, suggesting a number of new approaches based on different ways to subcategorize the industry. In fact, at least one commenter recognized that if the existing scheme was not defensible, one alter- native would be to abandon subcategories. This com- menter, also a petitioner, Monsanto, wrote: “It is our belief that additional partitioning of chem- ical groups based on the above environmental impact factors must be accomplished if the Agency intends to pursue the subcategorization approach.” App. at 1905. (Emphasis added.) Clearly Monsanto realized that the Agency would have to consider alternatives and was not finally committed to subcategories. Moreover, Monsanto’s response indicates that the Agency had not misled petitioners into thinking that they need only state views on the desirability of more subcategories rather than the undesirability of fewer. Another repeated call of the industry commenters was that the subcategories should be more equitably treated because the record did not support the significantly dif- ferent guideline limits assigned to the different sub- categories.” They should have realized that these crit- icisms, if accepted, could be resolved, among other ways, by applying the same limits to all organic pesticides. Again, though EPA’s solution was not the one for which industry argued, it was suggested by and, in part, a logical outgrowth of industry’s comments. They cannot ® Mobay, for instance, expressed its concern that the interim limitations “for the organo-phosphorus subcategory were based on prejudiced and . . . inequitable treatment when compared to the halogenated organics and organo-compounds [sic].” App. at 1755. lla now complain because they misread the regulatory wa- ters, incorrectly anticipated how EPA would react to their criticisms, and, consequently, submitted comments that left some things unsaid. Not only do we think that petitioners had fair notice that consolidation of subcategories was an issue to com- ment upon, but we cannot think how their comments would have differed fundamentally if they had known what EPA would do. Though they would have had a different proposition against which to argue, their pro- posed solutions would, presumably, have been the same for the same reasons. They might have responded in greater volume or more vociferously, but they have not shown us that the content of their criticisms would have been different to the point that they would have stood a better chance of convincing the Agency to use more subcategories. In short, they had a fair opportunity to present their views on how the industry ought to be subeategorized. Their real complaint is that EPA re- jected those views. For the same reasons, we do not think EPA was obli- gated to provide further opportunity to comment on “its decision to limit the regulations to those pesticides for which there are reliable analytical methods” or “its de- determination that all pesticides can be treated to a single level regardless of differences in treatability of particular pesticides”. To the extent the latter differs from the decision to consolidate categories, it was clearly signalled in the interim regulations. As the commenters pointed out, the interim subcategories were based on physical structure and each included chemicals of diverse treatability. The industry’s comments plainly suggested that treatability ought to be taken into account.’ Sim- ilarly, as to the former, the interim regulations applied 10 For an example, see the comments of E. I. duPont de Nemours & Co., App. at 1915. 12a a limit on the discharge of total pesticides to all manu- facturers of pesticides. Any manufacturer that had rea- son to believe its pesticides could not be detected at the guideline limit had the opportunity to ask the Agency to change its regulations as to any particular pesticide or as to all pesticides. The Agency’s receptiveness to such comments is indicated by the very decision attacked, its elimination of limits as to all but 49 organic pesticides when confronted with information showing that others were not reliably detectible. There was no lack of notice as to these subjects. The last point we must address is a different and more difficult one. One of EPA’s justifications for con- solidating the subcategories and for reducing the dis- charge limits for many pesticides was the conclusion, based in part on “additional raw waste load and treat- ment data, and additional pilot plant and laboratory data” that “the waste waters of all organic pesticide chemicals can be treated or controlled to the levels docu- mented in the Agency’s data base.” 43 Fed.Reg. at 17777. The BASF petitioners argue that since the EPA’s conclusions were premised on “new data on the appli- cability and effectiveness of treatment by activated car- bon and by hydrolysis’ EPA should have entertained a new round of comments." Certainly nothing is more important than the bottom line numbers which determine whether individual plants are or are not in compliance with the regulations. The data that an agency has used to set proposed limits ob- viously should be subject to public comment if possible. Indeed, as another circuit court has noted, factual mat- ters “are especially subject to verification through the 11Tt is ironic that petitioners should be attacking EPA’s use of an expanded data base since a constant theme of their substantive attack on the regulations has beei that EPA did not collect enough data to support the regulations. 13a notice and comment process and less acceptably removed therefrom.” Weyerhaeuser, slip op. at 1030 n. 26. This does not mean, however, that any new numbers gathered after publication of proposed regulations must be submitted for comment. It is perfectly predictable that new data will come in during the comment period, either submitted by the public with comments or collected by the agency in a continuing effort to give the regula- tions a more accurate foundation. The agency should be encouraged to use such information in its final calcula- tions without thereby risking the requirement of a new comment period. Though in this instance the new in- formation is in the form of numbers, our inquiry is no different than where the new information takes any other form. We must decide whether using new data that reduced the effluent limits for many of the producers deprived the public of a fair opportunity to present views on the final data base. If data used and dis- closed for the interim regulations presented the issues for comment, then there is no need to seek new comment even though significant quantitative differences result. We conclude that EPA was within the law. The final regulations set the pesticide discharge limit on the basis of data from nine plants with recommended pesticide removal technology. Seven of these nine plants were mentioned in the interim development document as form- ing the basis for or supporting the limits set by the interim regulations.'"* These seven plants accounted for about 82 per cent of the data points used to determine the final limits. Their products, treatment systems, and raw waste load were all discussed in detail in the interim development document, as was what was known of the 12 One of these plants, able to meet the limits without all the components of a recommended treatment system, was not explicitly relied on in developing the interim limit, but was mentioned as supporting the reasonableness of the limit set. l4a content of their waste water discharges. On the strength of what was disclosed in the interim development docu- ment, therefore, petitioners could have commented on the applicability of these plants’ treatment systems to other plants, and on the importance of different processes, products, and volumes. More importantly, the interim development document disclosed the method by which EPA calculated the limits. This methodology was substantially the same for the interim and final regulations. EPA afforded petitioners the chance to make the most meaningful possible con- tribution to the regulatory process because the petition- ers could use the information to collect data at their own plants, analyze it, and submit it to EPA. Not only would such input have guaranteed that EPA would be acting on the most complete data base possible, but it would have guaranteed that the special problems faced by each petitioner would have been taken account of by EPA and contributed to the resulting limitations.’* Peti- tioners knew the role that every available piece of data would play in generating the limits. EPA used all the data supplied to it. As to these seven plants, petitioners knew all they needed to know in order to make a meaningful contribu- tion to the regulatory process and a meaningful comment on the regulations proposed. All they did not know was what the actual raw numbers would be. While these numbers were certainly crucial in setting the limits and and of obviously great interest to the petitioners, we are not convinced that knowing them would have significantly improved petitioners’ opportunity to comment. They 13 The purpose of requiring notice is to generate responses as well as to hold agencies to adequate procedures. Where petitioners do not take advantage of chances to influence the agency we must look with less favor on those petitioners’ allegations of inadequacy in the result. See Weyerhaeuser, at 1028 n.15. ae 15a would have had a different numerical target for their many complaints about the limits set, but that would not have greatly advanced their ability to make positive contributions to the process by criticizing from their own knowledge the treatment technologies recommended, the success they could anticipate by implementing those tech- nologies, and the analytical and statistical methodology EPA used to turn the raw numbers into effluent limits. In short, in this case, we think it was far more important for EPA to solicit comments on how it intended to col- lect and use data than on the data itself." Regulatory targets have no guarantee that proposed effluent limits, which they are capable of meeting, will stay the same. The purpose of soliciting comments is to be able to make informed changes, and those interest groups preferring looser limits are not the only ones whose comments are solicited. Other governmental agen- cies or public environmental protection groups are free to seek whatever changes they feel desirable, and the EPA is free to adopt those suggestions if it is persuaded. As for the two plants that did not contribute to the generation of the interim limits, the same arguments ap- ply in part. All they added to the process were more numbers to be used in the same way as the other num- bers. Their treatment technologies are not markedly dif- ferent from the others and conform to EPA’s fully dis- closed model technology.*® Moreover, were these two 14 To help illustrate, we think it apparent that had EPA made a serious arithmetical error in calculating the interim regulations so that the effluent limits were higher than they should have been if correctly figured, EPA would have been privileged to make the correction between proposal and final promulgation without sub- mitting the revision for new comment. 15 This case differs from Weyerhaeuser, at 1028-1031, because the Agency’s final published explanation fully accounts for the limits set. There are no undisclosed numbers or factors on which the Agency must rely to support its final limits. See id. at 1030. The same calculations on the same factors were used for both the interim and final regulation, although the factors’ values varied. l6a plants omitted from considération the final limits would be more stringent since both of these plants discharge more than the allowable amount of pollutants.*® B. EPA’s Scientific Methodology The BASF petitioners have tenaciously at*acked the methodology and data used by ESE in calculating the final effluent limitations for organic pesticides. If ESE’s work is not reliable, then the final limitations cannot stand. Partly because of a belated turnover of some 2000 pages of laboratory documents—all of those used by ESE for this rulemaking proceeding—we have been faced with three rounds of briefing memoranda, dealing with targets that were both moving and increasingly particularistic. If we are not to lose our bearings in this extensive cross- fire of chemical expertise, it is important for us to gain and hold a perspective both as to facts and law. ESE was retained in 1976, after EPA became dis- satisfied with the work done over the prior two years by another contractor. ESE thereafter collected data from pesticide manufacturers and did its own experimentation on samples of waste water, the manufacturers furnish- ing 95 per cent of the data, and ESE laboratory work accounting for 5 per cent. The methodology and resulting data used by ESE to identify and quantify organic pesticides relate to two techniques, gas chromatography (GC) and thin layer chromatography (TLC). The method attracting most of the controversy in this appeal is gas chromatography. It involves vaporizing a sample of effluent, passing it through a column filled with various materials, which impeded the flow of each compound at a characteristic rate. Results are recorded on a con- 16 Petitioners also complain about data from new plants being used to generate the final BOD and COD limits, but this was evi- dently because they misidentified one of the plants. In any case, substantially the same plants supplied the data for both the interim and final regulations. “ ———— Sj Pe rad xh % % 17a tinuous chart which shows a “peak” when each compound exits the column, thus identifying it in terms of the time it appears, and which indicates concentration by the height and area of the peak. The method is neither simplistic nor self-executing. It involves the use of sev- eral columns, the testing and calibrating of each with samples containing known quantities of known pesticides, continual checking, and constant alertness for the pres- ence of unforeseen substances which can distort the re- cording on the strip chart. The method succeeds only in careful and expert hands. The lore of gas chromatography has been recognized for some time, being the subject of a handbook compiled in 1972 by EPA’s Analytical Quality Control Laboratory (and the source of ESE’s practices in this rulemaking procedure), the “Analysis of Pesticide Residues .. .” in 1974 and “Analytical Procedures for Pesticides Approved by EPA per 40 C.F.R. Part 136”, App. 1997-2090. These compilations dealt with means of isolating interferences (distorting effects occasioned by the presence of unidenti- fied substances), the preparation of apparatus, calibra- tion, reagents, solvents, standard quality control prac- tices, the preparation of samples, extraction, clean-up, and reporting. Part of the product of ESE’s work lay in the development of a new handbook, the Quality As- surance Manual, which was in revision at least through September of 1977. The factors underlying the present controversy as to the methodology of identifying and measuring organic pesticides are threefold: the complexity of the process, the high degree of elimination of pollutants required by the regulations, and the penalties for non-compliance. 83 U.S.C. § 1319. Petitioners point with dismay to the analytical obstacles, pitfalls, and limitations which EPA 18a acknowledges and warns against,'’ and challenge the re- liability and adequacy of both GC and TLC. They fur- ther document their dismay by criticizing ESE for lack of an articulated quality control program; criticizing specific instances of ESE’s work; noting the wide dis- crepancies between analyses of the same samples by sev- eral manufacturers and by ESE; and challenging the inclusion of a requirement based on chemical oxygen demand (COD) as not being feasible or useful. The considerations governing our task of review in such a case as this have been recently illumined in Weyerhaeuser Co. v. Costle, at 1025, where Judge Mc- Gowan, writing for the court, said: “In light of the structure and aims of the Act, and the breadth of authority delegated by it to the EPA to identify highly sophisticated control tech- nology in an area fraught with scientific uncer- tainty, our review function encounters significant limitations in the substantive aspect where the given statutory standards are ‘arbitrary,’ ‘capricious,’ or ‘abuse of discretion.’ First, it is elementary that our function is not to weigh de novo the available 17 The introductory material in “Analytical Procedures” describ- ing the application of gas chromatography to organochlorine pesti- cides contains such language as: “Under favorable circumstances, Strobane, toxaphene, chlordane (tech.) and others may also be de- termined”; “The usefulness of the method for other specific pesti- cides must be demonstrated by the analyst before any attempt is made to apply it to sample analysis”; when there are “complex mixtures, the individual compounds may be difficult to distin- guish .... Provisions incorporated in this method are intended to minimize the occurrences of such interference”; “the method offers several analytical alternatives, dependent on the analyst’s assess- ment of the nature and extent of interferences and/or the com- plexity of the pesticide mixtures found”; “This method is recom- mended for use only by experienced pesticide analysts or under the close supervision of such qualified persons”; “It is not possible to describe procedures for overcoming all of the interferences that may be encountered in industrial effluent.” Nae hoe 19a evidence and to substitute our judgment for that of the Agency. Second, an expansive concept and ex- ercise of the review power in the eleven Courts of Appeals charged with that function could easily impede accomplishment of the Act’s ambitious pol- lution-ending aspiration as well as its goal of indus- try-by-industry uniform*ty. See generally, Currie, Judicial Review Under Federal Pollution Laws, 62 Iowa L.Rev. 1221, 1261-71 (1977). This problem looms larger in the substantive area of review than it does in those areas involving statutory interpreta- tion and procedural integrity because of the tech- nological and scientific uncertainty that EPA must overcome as best it can in making the discretionary judgments delegated to it by Congress. There are also obvious limitations upon the capacity of courts to deal meaningfully with arcane areas of knowl- edge of this kind.” After quoting from the court’s earlier opinion in Jndus- trial Union Dep’t v. Hodgson, 162 U.S.App.D.C. 331, 338-39 n. 18, 499 F.2d 467, 474-75 n. 18 (1974) (“Where existing methodology or research in a new area of regu- lation is deficient, the agency necessarily enjoys a broad discretion to attempt to formulate a solution to the best of its ability on the basis of available information.”), Judge McGowan summarized the court’s view of its mission : “In these circumstances, therefore, we will be con- tent in carrying out our substantive review (that is, assuming the statute and the requisite procedures have been followed), first, to insist upon an explana- tion of the facts and policy concerns relied on by the Agency in making its decision; second, to see if those facts have some basis in the record; and finally, to decide whether those facts and those legislative con- siderations by themselves could lead a reasonable 20a person to make the judgment that the Agency has made. See Citizens to Preserve Overton Park, Inc. v. Volpe, supra, 401 U.S. [402] at 416, 91 S.Ct. 814, 28 L.Ed.2d 1386; Amoco Oil Co. v. EPA, 163 USS. App.D.C. 162, 180-181, 501 F.2d 722, 740-41 (1974) ; Industrial Union Dep’t v. Hodgson, supra, 162 U.S. App.D.C. 331, at 339-40, 499 F.2d 467, at 475-76.” Weyerhaeuser, at 1026. With these precepts in mind, we consider petitioners’ challenges. The first is to the reliability and adequacy of the two basic methods endorsed by EPA, gas chromatography and thin layer chromatography. Petitioner’s general attack is based, as we have noted in note 17, on the acknowl- “ edged uncertainties attending the successful use of the methods in dealing with complex mixtures. It seems to us that EPA’s cautions are to be preferred by far to overclaiming or overselling. It also seems to us that action of this nature, although not without risk to manu- facturers, is preferable to no action at all. We are mindful of the fact that Congress contemplated a certain amount of “technology forcing’, Weyerhaeuser, at 1057, expecting EPA “to press sometimes beyond the most advanced technology currently being used”. Jd. at 1061. Here, there is no claim that the technology has not been developed but merely that EPA has overstated its public acceptance. If the issue were whether the American So- ciety for Testing and Materials (ASTM) and the Ameri- can Public Health Association (APHA) had approved GC methods for testing all three classes of organic pesticides for which EPA claims GC to be appropriate, EPA might lose. But it seems clear to us, from the literature, in- cluding the series of manuals and handbooks dealing with both GC and TLC going back at least to 1972, and from the fact that several EPA test methods for organic pesticides have almost completed running the gamut of ( i} 4 ; ¢ PAN I € } $ e 2la ASTM and APHA approval processes, that any a priori attack on the methods must fail. This leads us to more specific criticisms. The most sweeping of these is petitioners’ claim that ESE, so far as the record discloses, pursued no systematic and re- liable quality control procedures in running its tests on samples of effluent. In its initial form the argument was that the many steps ** prescribed in the Chemistry Divi- sion and Radiochemical Laboratory Quality Assurance Manual, which ESE itself developed, were not followed. EPA’s response, that this Manual was in preparation during most of the time ESE was running its tests, seems sufficient to us.’® Petitioners counter that whether judged by the new Manual or the 1972 Handbook, ESE’s procedures were nowhere described or approved by EPA. This seems to be trve. Were the project for which ESE was engaged that of applying standard technology to routine operations, we might expect to find a pre- established testing procedure. But here part of the task was to find and develop the appropriate testing technol- ogy, resulting in the new Quality Assurance Manual. 18 These included a complete description in final project reports of methods used, a pre-established quality assurance plan for each project, the use of quality control input sheets and instrument log books, determination of maximum times for holding samples, documentation of ways in which samples were selected, calibration of instruments, frequent preparation of “linearity curves”, fre- quent running of standards to keep track of changes on the per- formance of the equipment, and routine checks through running a blank (solvent extracted from distilled water) through the column, conducting duplicate analyses of the same waste water sample, and running “spiked” samples (waste water to which known quantities of pesticides have been added). 19 Petitioners point out that tests of one manufacturer, Olin, were not completed until after the Manual was fully revised. Their argu- ment that failure of ESE to jettison its prior procedures and follow the newly promulgated Manual in conducting the very last tests on one plant’s samples constitutes adequate basis for remand seems to us utterly unrealistic. 22a ESE came on the scene after a prior contractor had been found inadequate. It obviously had a mandate to produce scientifically acceptable work; EPA had demon- strated its reaction to inadequacy. Between late 1976 and the fall of 1977 ESE invested 16,500 man hours in this rulemaking process. (App. 1491) As we have noted, all of its working papers, totalling 2000 pages have been turned over to petitioners. The specific criticisms we shall later discuss are the total harvest of hindsight. Most, we think, are answered satisfactorily by EPA; some are ignored. We find ourselves, as a reviewing court, dealing with adversaries who deal with the issues on different levels. Petitioners have combed the record to select what they deem to be errors or examples of sloppy work. EPA, on the other hand, seems to have adopted a rather bland approach, selecting only what it views as important challenges, and giving them a min- imum response. The issue of ESE’s quality control standards offers an example of these diverse approaches. Petitioners de- ery the absence of a description of methods, quality con- trol charts, the failure to prepare a “reproducible stand- ard curve”, the failure to run an adequate number of standards, an inadequate number of spiked and “method blank” samples, and duplicate analyses insufficient in quantity and quality. Their citations to the record are few. EPA’s response to this range of criticism is largely set forth in the following footnote language in its mem- orandum responding to petitioners’ reply brief: “Com- plaints of inadequate numbers of standard and spiked samples are refuted by laboratory documents supplied petitioners pursuant to the Court’s request at argument.” We have therefore conducted our own review. It was restricted to 238 pages of ESE documents (App. 3352- 3590). It was necessarily superficial, since we are not laboratory technicians, since the function of the various 23a forms and entries was often not self evident, and since many of the forms were illegible, some were apparently duplicates (App. 3469, 3470; 34138, 3556) or triplicates (App. 3368, 3474, 3582), and a sizeable number were upside down. We found frequent evidence that ESE testing had involved the running of duplicates,*° stand- ards,’ blanks,” and spiked samples.** Occasionally we found apparently careful step-by-step instructions for performing tests (App. 3352, 3505); notations that a test was defective and ought to be repeated (App. 3476, 3502) ; remarks that samples had been lost (App. 3414, 3431) or that the recording pen had jiggled on several chromatograms (App. 3412); and interpretive remarks noted in December, 1978, apparently for use of petition- ers (App. 3432, 3487-3489, 3491-3492, 3495). We have also read ESE’s monthly progress reports to EPA and see evidence of concern for careful procedure. (App. 1453, 1455, 1456, 1460, 1461). We cannot be sure that these references are an ade- quate response to criticisms levied at ESE’s general con- trol procedures. But we cannot play the role of Super- chemist.** Petitioners bear an extremely heavy burden 20 Vol. 10, App. 3353, 3356, 3363, 3382, 3426, 3439, 3460, 3469, 3470, 3473, 3484, 3485, 3490, 3493, 3494, 3498, 3499, 3501, 3515, 3516, 3518, 3520, 3521, 3523, 3565, 3566, 3567, 3582, 3590. 21 App. 3355, 3382, 3388, 3433, 3490, 3493, 3500, 3501, 3502, 3503, 3514, 3515, 3517, 3527. 22 App. 3520, 3522, 3523, 3448, 3450, 3454, 3476, 3493, 3494, 3498, 3500. 23 App. 3439, 3460, 3472, 3473, 3475, 3476, 3565. 24 Here is an example of thrust and parry between chemists where we are being asked to give the final answer. Petitioners: ESE did not run duplicates for 4 or 5 plants relied on. (Main brief, p. 46) EPA: It did, at all 4, citing appendix references. (Main brief, p. 56, n.64) Petitioners: But for duplicate samples to provide quality con- trol over extraction and clean-up techniques, the duplicate 24a if they desire to demonstrate that the results of a rule- making procedure are infected with fatal flaws of labora- tory practice. Our review, partial and facial though it is, satisfies us of the probability that EPA was justified in basing its regulation on ESE’s work. Our feeling is strengthened by our review of some of the specific instances of alleged error in results charged by petitioners. They have pointed to the wide diverg- ence of the analyses conducted principally by manu- facturers Rhom and Haas and Eli Lilly and those per- formed by ESE on “split” samples of the same waste water. ESE consistently found much higher quantities of pesticide in the samples. As we have indicated above, we have not found sufficient reason to reject ESE’s analytical procedures or results. And, while the methods generally used by the companies were sufficiently re- liable,2* we know nothing of the procedures actually used samples must be independently extracted, cleaned up, and in- jected into the column. (Reply brief, p. 18) EPA: But the samples were so laden with pesticide, that they had to be preserved in chloroform; this meant that when a sample container was opened, the whole sample would have to be used immediately. Hence ESE could run only injection duplicates. (Memorandum in response to petitioners’ reply brief, p. 6) Petitioners: No. The layering that might be induced by chloroform could be avoided by mixing the sample just prior to splitting. Moreover, the need to preserve the sample arose because of ESE’s excessive delay. Also, ESE’s alleged method does not provide for the use of chloroform. Also, the lab notes say nothing about the need to shortcut making parallel extrac- tions. (Memorandum in response to EPA memorandum, p. 4) 25 As EPA noted in 43 Fed.Reg. 17776, 17781 (1°78) : “The analytical procedures utilized by each manufacturer were sclicited by EPA and evaluated by the Environmental Monitoring and Support Laboratory in Cincinnati. The data utilized in establishing these limitations were derived from analytical methods which, in the opinion of the Cincinnati Laboratory, ‘appear capable of measuring the compound with adequate sensitivity.’ ” W asRie mach. ein id Sees rc 2 coe atthe os eee st wer! eS I a 25a by the companies in taking and preserving these samples. We therefore cannot say that the divergence of results indicates error on the part of ESE. Moreover, of course, rejection of the lower figures is to the ultimate advantage of the companies, increasing the allowable discharge. Petitioners also focused on what first appeared to them as a “patent error” in ESE’s calculations of the amount of waste water used in a test, amounting to more than a 55 gallon drum. But this turned out to be cor- rect, EPA saying that the sample was so polluted that it had to be diluted 250,000 times. Petitioners noted two strip charts for sample 9010, speculating that a “shoul- der” indicated interference and that a peak which ran off the paper could not be only 3.6 centimeters high. But EPA counters by saying the first peak was so pesticide- laden that it did indeed run off the paper, but that the rerun was indeed 3.6 centimeters high. The supposed interference denoted by the shoulder was the occasion for the technician’s comment we have noted concerning the jiggling of the recorder pen. App. 3412. Other charges were that two strip charts supposedly representing dupli- cate analysis were not “remotely comparable’—the re- sponse being that they were successive analyses with the differences due to the large amount of pesticide present in the ‘early extractions; that ESE improperly used higher influent numbers ascertained by a Perkin-Elmer instrument with no explanation for rejecting the lower numbers obtained by a Varian instrument—the reply being that each instrument is more effective in different ranges of numbers. Although petitioners have a retort in each such instance, we must say that EPA clearly has the better of these arguments. There are other even more minor issues where we confess that we are not sure of the winner—whether as to a particular analysis, a standard strip chart should have been verified, whether ESE’s injections were too 26a little in volume, whether the lack of confirmatory tests on alternate columns of different polarity was significant. As to these and other issues, EPA either did not respond or did not do so at sufficient length to be understandable. But we have said enough to indicate that residual doubt on issues of increasing minuteness is far from sufficient to cause us to interpose a different judgment than that exercised by the Agency in choosing to rely on its con- tractor. Petitioners have raised one additional issue of a sub- stantive technical nature in challenging EPA’s choice of COD as a parameter. The contention is that it serves no purpose where wastes possessing large amounts of salts are to be dealt with. Diamond Shamrock’s data are said to be of doubtful validity. But without such data, leaving only that developed by Monsanto’s Muscatine and Anniston plants, the standard would be even more strin- gent. Wholly apart from absence of prejudice, EPA points to the wide use of COD in industry as a measure of long term biochemical oxygen demand and a com- ment from Olin that “[I]t is a mystery why the Agency feels compelled to establish a limitation on BOD when COD measurements are more feasible.” C.App. 212.7¢ We cannot, in the words of the court in Weyerhaeuser, slip op. at 23, say that “a reasonable person [could not] make the judgment that the Agency has made.” C. EPA’s Determination of Best Practicable Control Technology Currently Available Even accepting the work of ESE as accurate, peti- tioners argue that the results do not support EPA’s conclusion that carbon adsorption and hydrolysis are ef- fective technologies for pre-treating pesticide waste streams to remove organic pesticide chemicals. Closely 26 References to the confidential portion of the appendix will be to “C.App.”. 27a related to this challenge are the arguments that the num- bers with which EPA calculated the final effluent limits were inaccurate, thus invalidating those limits, and that EPA could not reasonably combine all manufacturers of organic pesticides into one category required to meet the same limits. EPA’s decision that by using the model technology, including either carbon adsorption or hydrol- ysis, all plants achieved “similar” pesticide content in their effluent led EPA to conclude “that the waste waters of all organic pesticide chemicals can be treated or con- trolled to the levels documented in the Agency’s data base.” 43 Fed. Reg. 17777 (1978). In carbon adsorption, the organic molecules reach the surface of the carbon where they diffuse into the car- bon’s porous structure and bind with the carbon. The molecular structure and solubility of the pesticide in- fluence its adsorption characteristics. Periodically the carbon becomes saturated and requires regeneration which can be accomplished by incineration. The result- ing flue gases are quenched, scrubbed, and discharged to the atmosphere. The carbon can then be reused, al- though its adsorptive capacity will be somewhat reduced. Hydrolysis is a chemical process in which the pesticide compounds are broken down by adding a caustic (or an acid) to the waste water setting off a reaction with the water and the organic compounds. The hydroxyl or hy- drogen ions attach to some part of the pesticide chemical molecule, either displacing part of the group or breaking a bond so that two or more new compounds form. The suecess of hydrolysis is a function of the temperature and pH (relative acidity or alkalinity) of the solution and the properties of the chemical. Some compounds hydrolyze relatively easily compared to others. The ability of a compound to be hydrolyzed can be measured in terms of the half-life of the reaction, the time it takes at a given temperature and pH to hydrolyze half the chemical 28a present. The shorter the half-life, the easier it is to de- stroy the pesticide through hydrolysis. The regulations do not require the use of any par- ticular treatment technology so long as the effluent limitations are met. One of the premises of the regula- tions, however, is that by using either carbon adsorption or hydrolysis, together with equalization and biological treatment, any plant could meet the regulations. Pe- titioners argue that there is no basis for this conclusion and that, therefore, we should remand the regulations as to the organic pesticides category. They suggest that the data collected at operating facilities are unrepresenta- tive, inaccurate, and insufficient to demonstrate that those facilities achieve the results EPA claims; that even if those facilities do achieve the results claimed there is no data to suggest other plants producing other pesticides could achieve comparable results; and that EPA’s ref- erences to literature and pilot studies fail to support its conclusion. We emphasize again that our review of agency rule- making is very limited, especially where the Agency must overcome technological and scientific uncertainty in making its delegated discretionary decisions. See Weyerhaeuser, at 1025. We will not remand so long as the Agency has explained the facts and policies on which it relied; the facts have some basis in the record; and a reasonable person could make the judgment the Agency made. Jd. at 1026. Thus, the petitioners carry an ex- tremely heavy burden when petitioning for review in such a case as this. EPA identified eight full-scale carbon treatment sys- tems used to reduce pesticides and five full-scale hydrol- ysis systems. The Agency sought information on all these facilities. One of the plants using carbon adsorption (one of the petitioners before us) disclosed neither the operat- ing conditions of the system nor individual analyses of ¥ 4 4 2 : 4 i 29a its effectiveness. Information on the remaining 12 sys- tems is presented in great detail in section VII of the Development Document. Five of the seven carbon sys- tems achieve removal rates in excess of 99 per cent of the influent pesticide as do two of the three hydrolysis systems for which data is available as to the pesticide content of both the influent and effluent of the treatment system. The two hydrolysis systems, for which only effluent data is available reduced the pesticide level to less than 1 mg/1 (one part per million) and to below the detection point respectively. EPA has concluded that the two substandard carbon systems and one sub-stand- ard hydrolysis system could all achieve much better re- sults by adjusting the operating conditions of the fa- cilities (replacing the carbon more often or holding the waste water in the treatment system for a longer period). Petitioners attack the use of data from the carbon systems because the systems were not designed to re- move pesticides. This attack is trivial. EPA faces a severe problem in regulating the pesticide industry be- cause a great deal is not known about treatment of pesticide waste waters and because the industry is very reticent about revealing what it does (or could) know. Given this admitted information shortage EPA must make use of the information it has, recognizing the limits of the information; EPA cannot refuse to carry out its mandate, waiting for the day when it might possess perfect information.** Whatever reasons industry might 27 By the same token, petitioners’ broadbased attack on EPA’s use of data in literature must be rejected out of hand. Certainly the literature data are not as valuable as operating plant data would be, but the plants have not supplied enough information, and the literature is useful for what it does say. For instance, if the literature identifies a particular pesticide as amenable to treatment by adsorption or hydrolysis under laboratory conditions, that does not guarantee the same results under industrial conditions, but neither does that mean the information should be ignored. It means that, other things being equal, the pesticides can be treated. It is 30a have had for installing carbon treatment systems, if those systems are effective at removing pesticides then EPA can and should make use of that information. The alter- native would be to ignore the mandate of the Federal Water Pollution Control Act and allow the pesticide in- dustry to develop treatment systems at its own pace, releasing information about those systems only for the purposes and under the conditions the industry might see fit. Congress has rejected that alternative. The same answer applies to petitioners’ claim that the data on carbon treatment systems were too sparse to support any conclusion about their effectiveness. EPA had no more than 25 observations at any given facility and as few as 4 observations at another. EPA used all the data it could accumulate. Had the industry come forward with more data there is every indication that EPA would have used it. Data on the performance of the treatment systems are entirely within the control of the industry. We will not hear industry complain that EPA used insufficient data when industry was un- cooperative in supplying the missing data. It was up to EPA to decide whether the limited data base was suf- ficient to support the conclusions reached. We hold that deciding to base conclusions on the limited data available was a reasonable exercise of discretion given the regula- tory mandate.*® then up to the Agency experts to decide whether relaxing the labora- tory conditions would so change the result that the pesticide could not be treated by industry. Merely attacking the literature because it is experimental is no help to petitioners’ cause unless they can also show that the particular conclusions drawn from the literature are unreasonable. We have found nothing in the Act to 28 EPA took account of the limited data at some plants by using a weighted average that gave relatively less weight to facilities outlaw scientific deductive reasoning. from which it had fewer observations in the calculations of the final effluent limitations. RON OL ye a Gee Fa a, me Seow AGe! , pa DP PTH CORI Bone ig ak iA eS 3 z 4 & ' 3 4 i] 3 2 Ae ib wi Aish vk Sis, oe 3la Petitioners suggest that even the limited data avail- able at three of the carbon treatment plants are unrep- resentative because the data were collected too soon after replacement of the carbon columns or because some wastes bypassed the treatment system being studied. The sampling at Eli Lilly covered the first 4 days of a 7 day carbon cycle. The record does not reveal why the carbon was changed just before sampling began or whether either ESE or Lilly timed the change purposely. The data, however, covered more than half the cycle, and the record reveals that the results obtained during the ESE sampling period were, if anything, unrepresenta- tive on the high side since they showed a higher con- centration of pesticide in the treatment effluent than the company found in its own studies. C.App. 217. The sampling at Hardwicke was done early in that company’s normal 30 day carbon cycle, but, as EPA noted, the car- bon should be changed far more frequently and the sampling was fairly representative of what would have been a reasonable carbon cycle for the plant. Petitioners also argue that Lilly and Olin generated waste streams containing pesticides that did not pass through the treatment systems. Their citations with re- gard to Lilly are unconvincing. The direct communica- tion from Lilly says nothing about a pesticide-bearing waste stream by-passing carbon treatment. The MITRE study does not support the claim. It says that the only two waste sources containing the pesticide may be com- bined prior to treatment. C.App. 206. We find no in- dication that the “Floor drains, Cooling Waters, and Miscellaneous Waste Streams” contained any pesticide. C.App. 207. The problem with respect to Olin is not so easily dis- posed of. On March 15, 1977, Olin submitted its com- ments on the interim final regulations. It stated that EPA’s data omitted “supplementary waste streams con- ¢ 32a taining some process wastewaters.” C.App. 213A. An attachment to these comments described the supplemen- tary waste streams as including “among other things, spills, wash-downs, vent scrubber effluents, and surface runoff. In this wastestream, the following waste by- product streams are not included: 1. PCNB Plant Hy- drochloric Acid; 2. PCNB Plant Spent Sulfuric Acid; 3. TCAN Plant Hydrochloric Acid.” C.App. 218A. Finally, this letter stated as “basically an intelligent guess” that 1.3 pounds of pesticide were in the supplementary waste stream (not including “TCAN, HCL, PCNB HCL and PCNB spent nitration acid.”). EPA visited Olin’s plant on August 17, 1977. According to a memorandum of that visit, “[p]lant personnel were unable to provide back-up information supporting the revised waste load estimates reported to EPA in a letter from Olin dated March 15, 1977. They argeed to provide the basis of these revised waste loads upon receipt of a letter from EPA.” C.App. 304. On August 18, 1977, EPA sent a letter to Olin seeking, inter alia, more information about the supple- mentary waste streams; confirmation that “these supple- mentary waste streams have not been, and are not cur- rently being treated by activated carbon, but rather are neutralized and discharged”; and confirmation that the existing “waste byproduct streams” (the acid streams) were being reused or sold. App. 2625-26. Olin answered by letter of September 14 that it had no additional data on raw waste load (other than some flow rate data) ; that “[t]he supplementary waste streams associated with the PCNB Plant are currently only being neutralized” ; and that “(t]he information you have outlined for the current disposition of the three by-product acid streams is correct.” C.App. 352-53. EPA’s response to petitioners’ argument is that “[t]he truth as acknowledged by Olin, is that there are no [unaccounted for] streams.” EPA brief at 62. EPA’s brief-writers misread the exchange quoted above. They 33a interpreted Olin’s acknowledgement that the three acid by-product streams were not being discharged as mean- ing that no supplementary waste streams were being discharged. A clear distinction was made at all times in the exchange of correspondence between the acid “by- product waste streams” and the pesticide-bearing supple- mentary waste stream. The latter is clearly the one of concern, and Olin clearly stated that it was being dis- charged with no treatment other than neutralization. The implication is that Olin was discharging more pounds of pesticide per thousand pounds of production than the figure EPA used in calculating the limits, and, therefore, the limits were miscalculated and should be corrected.” The treatment given the issue in EPA’s brief leaves us uncertain how to handle it. On the one hand, we might be inclined to discount an “intelligent guess” about extra pesticide when no supportive data is forthcoming despite the Agency’s follow up efforts. On the other hand, though, EPA has not explained the basis for ignoring the new information, and EPA’s brief deals with it on an inaccurate basis.*° Under these circum- stances we feel compelled to remand the regulations for consideration of petitioners’ claim that the Olin data should not be used in calcualting the final effluent limits. . It may be that EPA can easily correct any defect, but we must put them to the task. Similar arguments are directed against plants EPA used to illustrate hydrolysis treatment. Petitioners ob- 29 This confusion cannot impugn the conclusion that Olin’s carbon adsorption system effectively treats the waste streams that in fact pass through it. 30 The brief-writers compound the inaccuracy (and diminish our trust in them) by arguing that the 1.3 pound figure must be dis- believed because it disagrees with data submitted by Olin on Sep- tember 14, 1977. C.App. 353. That data only concerned the influent and effluent of the carbon adsorption system. The 1.3 pound figure related to waste not passing through the system. 84a ject to reliance on two plants claiming that in fact neither has an hydrolysis system. In fact the record reveals that both plants hydrolyze the waste [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_IA40385006_0971%3A1. Public record. Not legal advice.