Opinion ID: 366280
Heading Depth: 1
Heading Rank: 1

Heading: Organic Pesticide Manufacturing

Text: 6 Petitioners' first complaint is that EPA failed to comply with the requirements of the Administrative Procedure 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 proposed 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 reasoning tested by exposure to diverse public comment. Though our review of an agency's final decision is relatively 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). 7 In this case EPA issued interim final regulations and sought comments on them. Industry representatives, government agencies, and others submitted voluminous comments on many aspects of the interim regulations. It is clear that EPA gave careful consideration to these comments. 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, 3 abandoned use of COD/BOD ratios 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. 8 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 opportunity for comment merely because the rule promulgated by the agency differs from the rule it proposed, partly at least in response to submissions. International Harvester Co. v. 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, 132, 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). 9 The essential inquiry is whether the commenters have had a fair opportunity to present their views on the contents of the final plan. 4 We must be satisfied, in other words, that 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. Weyerhaeuser, at 1031. Thus, where the final rules are the result of a complex mix of controversial and uncommented upon data and calculations, remand may be in order. Id. 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. American Frozen Food Institute, supra, 176 U.S.App.D.C. at 133, 539 F.2d at 135. The question, however, always requires careful consideration on a case-by-case basis. 10 The first and principal change complained of is the Agency's decision to merge the first three interim subcategories 5 into a single Organic Pesticide Chemicals Manufacturing subcategory. 6 So far as the record discloses, petitioners were not aware of this change until the final regulations were promulgated and the time for comment had expired. EPA consolidated the former subcategories because it recognized certain ambiguities were present in its subcategorization based on chemical structure. Many pesticides contain more than one functional group . . . and do not fit the former subcategorization scheme. 43 Fed.Reg. 17777 (1978). Consequently, and in response to industry comments, EPA undertook further 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 controlled to the levels documented. . . . Thus, the final regulations do not differentiate among halogenated organic, organo-phosphorus, or organo-nitrogen pesticide chemicals. Id. 11 The industry comments were almost unanimous in condemning the three original subcategories both for being internally inconsistent and insufficiently differentiated from the other categories. 7 Comments presented statistical tests of EPA's data, purporting to show that the subcategories were not distinguishable from each other. 8 Comments also pointed to the inclusion of very different compounds within particular subcategories. The comments made a strong case against use of the interim subcategories, and EPA decided that the criticism was persuasive. It follows that EPA had to decide on an alternative unless it was to abandon regulation 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 expanding 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. 12 Neither suggestion is grounds for remand. 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. The commenters cannot claim they had no notice to propose and discuss alternatives. 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 alternative would be to abandon subcategories. This commenter, also a petitioner, Monsanto, wrote: 13 It is our belief that additional partitioning of chemical 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.) 14 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. 15 Another repeated call of the industry commenters was that the subcategories should be more equitably treated because the record did not support the significantly different guideline limits assigned to the different subcategories. 9 They should have realized that these criticisms, 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 now complain because they misread the regulatory waters, incorrectly anticipated how EPA would react to their criticisms, and, consequently, submitted comments that left some things unsaid. 16 Not only do we think that petitioners had fair notice that consolidation of subcategories was an issue to comment 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 proposed 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 subcategorized. Their real complaint is that EPA rejected those views. 17 For the same reasons, we do not think EPA was obligated 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 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. 10 Similarly, as to the former, the interim regulations applied a limit on the discharge of total pesticides to all manufacturers of pesticides. Any manufacturer that had reason 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. 18 The last point we must address is a different and more difficult one. One of EPA's justifications for consolidating the subcategories and for reducing the discharge limits for many pesticides was the conclusion, based in part on additional raw waste load and treatment 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 documented 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 applicability and effectiveness of treatment by activated carbon and by hydrolysis EPA should have entertained a new round of comments. 11 19 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 obviously should be subject to public comment if possible. Indeed, as another circuit court has noted, factual matters are especially subject to verification through the notice and comment process and less acceptably removed therefrom. Weyerhaeuser, slip op. at 1030 n. 26. 20 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 regulations a more accurate foundation. The agency should be encouraged to use such information in its final calculations without thereby risking the requirement of a new comment period. Though in this instance the new information 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 disclosed for the interim regulations presented the issues for comment, then there is no need to seek new comment even though significant quantitative differences result. 21 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 forming the basis for or supporting the limits set by the interim regulations. 12 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 content of their waste water discharges. On the strength of what was disclosed in the interim development document, 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. 22 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 contribution to the regulatory process because the petitioners 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. 13 Petitioners knew the role that every available piece of data would play in generating the limits. EPA used all the data supplied to it. 23 As to these seven plants, petitioners knew all they needed to know in order to make a meaningful contribution 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 of obviously great interest to the petitioners, we are not convinced that knowing them would have significantly improved petitioners' opportunity to comment. They 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 technologies, 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 collect and use data than on the data itself. 14 24 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 agencies 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. 25 As for the two plants that did not contribute to the generation of the interim limits, the same arguments apply in part. All they added to the process were more numbers to be used in the same way as the other numbers. Their treatment technologies are not markedly different from the others and conform to EPA's fully disclosed model technology. 15 Moreover, were these two plants omitted from consideration the final limits would be more stringent since both of these plants discharge more than the allowable amount of pollutants. 16
26 The BASF petitioners have tenaciously attacked 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. 27 ESE was retained in 1976, after EPA became dissatisfied 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 furnishing 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 continuous 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 several columns, the testing and calibrating of each with samples containing known quantities of known pesticides, continual checking, and constant alertness for the presence of unforeseen substances which can distort the recording on the strip chart. The method succeeds only in careful and expert hands. 28 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 unidentified substances), the preparation of apparatus, calibration, reagents, solvents, standard quality control practices, 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 Assurance Manual, which was in revision at least through September of 1977. 29 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. 33 U.S.C. § 1319. Petitioners point with dismay to the analytical obstacles, pitfalls, and limitations which EPA acknowledges and warns against, 17 and challenge the reliability and adequacy of both GC and TLC. They further document their dismay by criticizing ESE for lack of an articulated quality control program; criticizing specific instances of ESE's work; noting the wide discrepancies between analyses of the same samples by several manufacturers and by ESE; and challenging the inclusion of a requirement based on chemical oxygen demand (COD) as not being feasible or useful. 30