Opinion ID: 366280
Heading Depth: 2
Heading Rank: 2

Heading: EPA's Scientific Methodology

Text: 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