1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 EASTERN DISTRICT OF CALIFORNIA 10 ----oo0oo---- 11 12 CLEAN WATER SOCAL and CENTRAL No. 2:23-cv-01149 WBS JDP VALLEY CLEAN WATER ASSOCIATION, 13 Plaintiffs, 14 MEMORANDUM AND ORDER RE: v. PLAINTIFFS’ MOTION FOR 15 PRELIMINARY INJUNCTION UNITED STATES ENVIRONMENTAL 16 PROTECTION AGENCY; and TOMAS TORRES, DIRECTOR, WATER DIVISION 17 of UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, REGION IX, 18 Defendants. 19
20 ----oo0oo---- 21 Plaintiffs Clean Water SoCal and Central Valley Clean 22 Water Association (collectively “plaintiffs”) are trade 23 associations with member agencies that own and operate wastewater 24 treatment plants and water reclamation plants. (See Compl. ¶ 11 25 (Docket No. 1).) Plaintiffs seek declaratory and injunctive 26 relief against defendants United States Environmental Protection 27 Agency (“EPA”) and the EPA’s Director of the Water Division for 28 Region IX, Tomas Torres (collectively “defendants”). (See 1 generally Compl.) 2 Plaintiffs allege that defendants’ approval of the 3 California State Water Board’s (the “State Water Board”) new 4 water quality standards (the “Toxicity Provisions”) violated the 5 Administrative Procedure Act (“APA”), 5 U.S.C. §§ 551 and 702 et 6 seq., and the various statutes and regulations responsible for 7 implementing the Clean Water Act, 33 U.S.C. § 1251 et seq. and 40 8 C.F.R. Part 131. (See generally Compl.) Specifically, 9 plaintiffs challenge the EPA’s approval of the Toxicity 10 Provision’s requirement that water toxicity testing be analyzed 11 using a method of statistical analysis known as the Test of 12 Significant Toxicity (“TST”). 13 Before the court is plaintiffs’ motion for preliminary 14 injunction.1 (Docket No. 15.) 15 I. Background 16 A. Statutory and Regulatory Framework 17 “The Clean Water Act prohibits ‘the discharge of any 18 pollutant by any person’ into the waters of the United States 19 without a permit.” S. Cal. All. of Publicly Owned Treatment 20 Works v. EPA (hereinafter “SoCal Works”), 8 F.4th 831, 834 (9th 21 Cir. 2021) (quoting 33 U.S.C. § 1311(a)). The Clean Water Act 22 allows the EPA “to delegate permitting responsibility to the 23 States.” (SoCal Works, 8 F.4th at 834) (citing 33 U.S.C. § 24 1342(b)); see also 40 C.F.R. § 131.4(a) (“States . . . are 25 1 Plaintiffs request that the court take judicial notice 26 of 11 documents, all of which are documents of public record. (See Reqs. for Judicial Notice (Docket Nos. 15-2, 30-2).) The 27 court will grant plaintiffs’ request for judicial notice because matters of public record are not reasonably subject to dispute. 28 See Lee v. City of L.A., 250 F.3d 668, 689 (9th Cir. 2001). 1 responsible for reviewing, establishing, and revising water 2 quality standards”). As of 2021, California was one of 47 states 3 to which the EPA had transferred permitting authority. SoCal 4 Works, 8 F.4th at 834. 5 EPA’s regulations require states to establish 6 limitations on the amounts of pollutants that permitholders may 7 discharge. See 40 C.F.R. § 131.11. “Pursuant to the Clean Water 8 Act’s National Pollutant Discharge Elimination System [“NPDES”], 9 33 U.S.C. § 1342(a), states retain discretion, subject to EPA 10 guidance and recommendations, to set their toxicity thresholds in 11 order to compensate for local conditions at the permitting 12 stage.” Edison Elec. Inst. v. EPA, 391 F.3d 1267, 1273-74 (D.C. 13 Cir. 2004). 14 Because a discharge can be toxic even when it complies 15 with the EPA’s limitations on pollutants, “the EPA also requires 16 certain permitholders to pass a test called a ‘whole effluent 17 toxicity’ (WET) test.” SoCal Works, 8 F.4th at 834 (citing 40 18 C.F.R. § 122.44(d)(1)(iv)). A WET test “measures the aggregate 19 effect of aquatic discharge on aquatic organisms . . . by 20 exposing a test population of organisms to a discharge and 21 counting how many die or become immobilized.” Id. (citing 60 22 Fed. Reg. 53, 529, 53, 532 (Oct. 16, 1996)); see also Edison 23 Elec., 391 F.3d at 1272-73 (describing the WET test). 24 Because toxicity “is not measurable as an absolute 25 amount or concentration[,] . . . . the biological results of a 26 WET test must be analyzed through a statistical approach.” 27 (Vacano Decl., Ex. 1 (“EPA Approval”) at 21 (Docket No. 22-1).) 28 EPA regulations list some methods of statistical analysis but 1 expressly state that they are “not the only possible methods.” 2 67 Fed. Reg. 69964. 3 B. The TST Method of Statistical Analysis 4 In 2010, the EPA issued a new guidance document which 5 “describe[ed] the TST as another statistical approach for permit 6 writers to consider” when analyzing WET tests.2 (EPA Approval at 7 26-27.) “[B]ecause ‘not toxic’ does not have an inherent 8 meaning, the application of the TST components is used to define 9 what constitutes ‘not toxic’ and thus the desired condition of 10 the water body.” (Id. at 24). Unlike previous statistical 11 methods used to analyze WET tests, “TST presumes that a sample is 12 toxic absent statistically significant evidence to the contrary.” 13 SoCal Works, 8 F.4th at 835. The TST is not explicitly listed as 14 a method of statistical analysis in the EPA regulations. 15 C. Factual Background3
16 2 “EPA developed the TST to provide increased confidence 17 in toxicity data assessment by controlling for specific types of errors that are typical in hypothesis testing.” (EPA Approval at 18 26.)
19 3 Plaintiffs have challenged the EPA’s approval of the TST twice before. In 2014, plaintiffs brought an action in this 20 district challenging the EPA’s approval of California’s use of the TST as an “alternative test procedure” under 33 U.S.C. § 21 1314(h) and 40 C.F.R. §§ 136.3(a), 136.5. See S. Cal. All. of POTWs v. EPA, No. 2:14-cv-01513 MCE DB. The case was dismissed 22 as moot after the EPA withdrew its approval. In 2016, plaintiffs brought another action in this district, this time alleging that 23 the EPA violated both the APA’s notice-and-comment rulemaking procedures and the EPA’s own regulations by allowing the use of 24 the TST when issuing permits. See S. Cal. All. of POTWs v. EPA, No. 2:16-cv-02960 MCE DB. The district court dismissed the case 25 on the ground that it was barred by the APA’s statute of limitations. See id., 297 F. Supp. 3d 1060, 1073 (E.D. Cal. 26 2018) (England, J.). Plaintiffs appealed.
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1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 EASTERN DISTRICT OF CALIFORNIA 10 ----oo0oo---- 11 12 CLEAN WATER SOCAL and CENTRAL No. 2:23-cv-01149 WBS JDP VALLEY CLEAN WATER ASSOCIATION, 13 Plaintiffs, 14 MEMORANDUM AND ORDER RE: v. PLAINTIFFS’ MOTION FOR 15 PRELIMINARY INJUNCTION UNITED STATES ENVIRONMENTAL 16 PROTECTION AGENCY; and TOMAS TORRES, DIRECTOR, WATER DIVISION 17 of UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, REGION IX, 18 Defendants. 19
20 ----oo0oo---- 21 Plaintiffs Clean Water SoCal and Central Valley Clean 22 Water Association (collectively “plaintiffs”) are trade 23 associations with member agencies that own and operate wastewater 24 treatment plants and water reclamation plants. (See Compl. ¶ 11 25 (Docket No. 1).) Plaintiffs seek declaratory and injunctive 26 relief against defendants United States Environmental Protection 27 Agency (“EPA”) and the EPA’s Director of the Water Division for 28 Region IX, Tomas Torres (collectively “defendants”). (See 1 generally Compl.) 2 Plaintiffs allege that defendants’ approval of the 3 California State Water Board’s (the “State Water Board”) new 4 water quality standards (the “Toxicity Provisions”) violated the 5 Administrative Procedure Act (“APA”), 5 U.S.C. §§ 551 and 702 et 6 seq., and the various statutes and regulations responsible for 7 implementing the Clean Water Act, 33 U.S.C. § 1251 et seq. and 40 8 C.F.R. Part 131. (See generally Compl.) Specifically, 9 plaintiffs challenge the EPA’s approval of the Toxicity 10 Provision’s requirement that water toxicity testing be analyzed 11 using a method of statistical analysis known as the Test of 12 Significant Toxicity (“TST”). 13 Before the court is plaintiffs’ motion for preliminary 14 injunction.1 (Docket No. 15.) 15 I. Background 16 A. Statutory and Regulatory Framework 17 “The Clean Water Act prohibits ‘the discharge of any 18 pollutant by any person’ into the waters of the United States 19 without a permit.” S. Cal. All. of Publicly Owned Treatment 20 Works v. EPA (hereinafter “SoCal Works”), 8 F.4th 831, 834 (9th 21 Cir. 2021) (quoting 33 U.S.C. § 1311(a)). The Clean Water Act 22 allows the EPA “to delegate permitting responsibility to the 23 States.” (SoCal Works, 8 F.4th at 834) (citing 33 U.S.C. § 24 1342(b)); see also 40 C.F.R. § 131.4(a) (“States . . . are 25 1 Plaintiffs request that the court take judicial notice 26 of 11 documents, all of which are documents of public record. (See Reqs. for Judicial Notice (Docket Nos. 15-2, 30-2).) The 27 court will grant plaintiffs’ request for judicial notice because matters of public record are not reasonably subject to dispute. 28 See Lee v. City of L.A., 250 F.3d 668, 689 (9th Cir. 2001). 1 responsible for reviewing, establishing, and revising water 2 quality standards”). As of 2021, California was one of 47 states 3 to which the EPA had transferred permitting authority. SoCal 4 Works, 8 F.4th at 834. 5 EPA’s regulations require states to establish 6 limitations on the amounts of pollutants that permitholders may 7 discharge. See 40 C.F.R. § 131.11. “Pursuant to the Clean Water 8 Act’s National Pollutant Discharge Elimination System [“NPDES”], 9 33 U.S.C. § 1342(a), states retain discretion, subject to EPA 10 guidance and recommendations, to set their toxicity thresholds in 11 order to compensate for local conditions at the permitting 12 stage.” Edison Elec. Inst. v. EPA, 391 F.3d 1267, 1273-74 (D.C. 13 Cir. 2004). 14 Because a discharge can be toxic even when it complies 15 with the EPA’s limitations on pollutants, “the EPA also requires 16 certain permitholders to pass a test called a ‘whole effluent 17 toxicity’ (WET) test.” SoCal Works, 8 F.4th at 834 (citing 40 18 C.F.R. § 122.44(d)(1)(iv)). A WET test “measures the aggregate 19 effect of aquatic discharge on aquatic organisms . . . by 20 exposing a test population of organisms to a discharge and 21 counting how many die or become immobilized.” Id. (citing 60 22 Fed. Reg. 53, 529, 53, 532 (Oct. 16, 1996)); see also Edison 23 Elec., 391 F.3d at 1272-73 (describing the WET test). 24 Because toxicity “is not measurable as an absolute 25 amount or concentration[,] . . . . the biological results of a 26 WET test must be analyzed through a statistical approach.” 27 (Vacano Decl., Ex. 1 (“EPA Approval”) at 21 (Docket No. 22-1).) 28 EPA regulations list some methods of statistical analysis but 1 expressly state that they are “not the only possible methods.” 2 67 Fed. Reg. 69964. 3 B. The TST Method of Statistical Analysis 4 In 2010, the EPA issued a new guidance document which 5 “describe[ed] the TST as another statistical approach for permit 6 writers to consider” when analyzing WET tests.2 (EPA Approval at 7 26-27.) “[B]ecause ‘not toxic’ does not have an inherent 8 meaning, the application of the TST components is used to define 9 what constitutes ‘not toxic’ and thus the desired condition of 10 the water body.” (Id. at 24). Unlike previous statistical 11 methods used to analyze WET tests, “TST presumes that a sample is 12 toxic absent statistically significant evidence to the contrary.” 13 SoCal Works, 8 F.4th at 835. The TST is not explicitly listed as 14 a method of statistical analysis in the EPA regulations. 15 C. Factual Background3
16 2 “EPA developed the TST to provide increased confidence 17 in toxicity data assessment by controlling for specific types of errors that are typical in hypothesis testing.” (EPA Approval at 18 26.)
19 3 Plaintiffs have challenged the EPA’s approval of the TST twice before. In 2014, plaintiffs brought an action in this 20 district challenging the EPA’s approval of California’s use of the TST as an “alternative test procedure” under 33 U.S.C. § 21 1314(h) and 40 C.F.R. §§ 136.3(a), 136.5. See S. Cal. All. of POTWs v. EPA, No. 2:14-cv-01513 MCE DB. The case was dismissed 22 as moot after the EPA withdrew its approval. In 2016, plaintiffs brought another action in this district, this time alleging that 23 the EPA violated both the APA’s notice-and-comment rulemaking procedures and the EPA’s own regulations by allowing the use of 24 the TST when issuing permits. See S. Cal. All. of POTWs v. EPA, No. 2:16-cv-02960 MCE DB. The district court dismissed the case 25 on the ground that it was barred by the APA’s statute of limitations. See id., 297 F. Supp. 3d 1060, 1073 (E.D. Cal. 26 2018) (England, J.). Plaintiffs appealed. In 2021, the Ninth Circuit affirmed dismissal, but on the alternative ground that 27 the 2010 guidance involving the TST was not a final agency action because it did not impose any legal consequences. SoCal Works, 8 28 F.4th at 836. 1 In October 2021, the State Water Board adopted the 2 state’s revised regulations regarding water toxicity, known as 3 the Toxicity Provisions. (Compl. ¶ 7.) The Toxicity Provisions 4 require that aquatic toxicity test data be analyzed using the 5 TST. (EPA Approval at 13.) On April 25, 2022, the Toxicity 6 Provisions were formally approved by the State, thereby becoming 7 state law. (EPA Approval at 20; Mot. at 15.) Two days later, 8 the State Water Board submitted the Toxicity Provisions to 9 defendants for review and approval, as is required by the Clean 10 Water Act, 33 U.S.C. § 1313(c).4 (Opp’n at 8.) 11 On May 1, 2023, defendants issued final approval of the 12 Toxicity Provisions. (Compl. ¶ 8; see generally EPA Approval.) 13 As a result of defendants’ approval, the Toxicity Provisions’ 14 requirement that the TST be used to analyze WET tests became 15 effective under the Clean Water Act. See 40 C.F.R. § 131.21(c). 16 Subsequently, on May 22, 2023, plaintiffs filed their Complaint 17 and, a few weeks later, moved for a preliminary injunction.5 18 As explained above, plaintiffs allege that defendants’ 19 approval of the Toxicity Provisions’ new requirement that water 20 toxicity testing be analyzed using the TST was arbitrary and 21
22 4 Once a state submits its new or revised water quality standards, the EPA has 60 days to approve the standards or 90 23 days to disapprove the standards. 40 C.F.R. § 131.21.
24 5 In July 2022, plaintiffs (and others) filed a similar case in state court, challenging California’s adoption of the 25 Toxicity Provisions. (Mot. at 15; Camarillo Sanitary Dist. v. State Water Res. Control Bd., No. 22CECG02195 (Fresno Sup. Ct.).) 26 In May 2023, the state court denied plaintiffs’ ex parte application for a TRO or stay. (See Opp’n at 9.) The hearing on 27 the merits in that case was scheduled for June 23, 2023. (Mot. at 15). There is nothing before this court to provide the status 28 of that action. 1 capricious, in violation of the APA. (See generally Compl.) 2 II. Discussion 3 “[I]njunctive relief [i]s an extraordinary remedy that 4 may only be awarded upon a clear showing that the plaintiff is 5 entitled to such relief.” Winter v. Nat. Res. Def. Council, 6 Inc., 555 U.S. 7, 22 (2008). To obtain a preliminary injunction, 7 the moving party must establish (1) it is likely to succeed on 8 the merits, (2) it is likely to suffer irreparable harm in the 9 absence of preliminary relief, (3) the balance of equities tips 10 in its favor, and (4) an injunction is in the public interest. 11 Id. at 20; Humane Society of the U.S. v. Gutierrez, 558 F.3d 896, 12 896 (9th Cir. 2009). “A plaintiff must make a showing on all 13 four prongs to obtain a preliminary injunction.” A Woman’s 14 Friend Pregnancy Res. Clinic v. Becerra, 901 F.3d 1166, 1167 (9th 15 Cir. 2018) (emphasis in original) (quotation marks and citations 16 omitted). 17 A. Likelihood of Irreparable Harm 18 “[A] preliminary injunction will not be issued simply 19 to prevent the possibility of some remote future injury.” 20 Winter, 555 U.S. at 21. “A threat of irreparable harm is 21 sufficiently immediate to warrant preliminary injunctive relief 22 if the plaintiff ‘is likely to suffer irreparable harm before a 23 decision on the merits can be rendered.’” Boardman v. Pac. 24 Seafood Grp., 822 F.3d 1011, 1023 (9th Cir. 2016) (quoting 25 Winter, 555 U.S. at 22). “Speculative injury does not constitute 26 irreparable injury sufficient to warrant granting a preliminary 27 injunction.” Id. 28 Both sides agree that this matter may be presented to 1 the court for final decision upon briefs as soon as the 2 administrative record is prepared, and government counsel 3 represented that it would take approximately 30 days for the EPA 4 to assemble and produce the administrative record. The parties 5 thus estimated that it should only take about 60 to 90 days 6 before the court could hear this case on the merits. 7 Plaintiffs argue that their members will be irreparably 8 harmed because they: (1) “will be subject to enforcement, civil 9 (and potentially criminal) penalties, and citizen suits for 10 failure to comply with new water quality standards; and (2) will 11 “be subject to economic harm, as they will now be required to 12 undertake more costly and burdensome toxicity testing 13 requirements.” (Mot. at 26.) However, plaintiffs provide no 14 tangible evidence that any civil enforcement actions or criminal 15 penalties are likely to occur in the short time before the court 16 can issue a decision on the merits. See Boardman, 822 F.3d at 17 1023 (plaintiff must demonstrate likelihood of suffering 18 irreparable harm “before a decision on the merits can be 19 rendered”) (citation and quotation omitted). 20 Both the State Water Board and its regional 21 counterparts have been issuing permits which require the TST 22 since at least 2012. (See Mitschele Decl. ¶ 3 (Docket No. 22- 23 3).) As of April 30, 2023, at least 190 effective NPDES permits 24 have been issued that require the TST. Id. ¶ 4. Absent a 25 showing that criminal or civil actions are imminent or likely to 26 occur, any harm is speculative and not immediate. Moreover, 27 “economic injury alone does not support a finding of irreparable 28 harm, because such injury can be remedied by a damage award.” 1 Rent-A-Ctr., Inc. v. Canyon Television & Appliance Rental, Inc., 2 944 F.2d 597, 603 (9th Cir. 1991) (citation omitted).6 3 For the foregoing reasons, plaintiffs have failed to 4 demonstrate the likelihood of irreparable harm before the court 5 can issue a decision on the merits, and for that reason alone the 6 court would be required to deny their request for a preliminary 7 injunction. 8 B. Likelihood of Success on the Merits 9 Even assuming plaintiffs were able to show a likelihood 10 of irreparable harm, they nonetheless fail to show a likelihood 11 of success on the merits. 12 “Section 706(2)(A) of the APA requires a reviewing 13 court to uphold agency action unless it is ‘arbitrary, 14 capricious, an abuse of discretion, or otherwise not in 15 accordance with law.’” San Luis & Delta-Mendota Water Auth. v. 16 Locke, 776 F.3d 971, 994 (9th Cir. 2014) (quoting 5 U.S.C. § 17 706(2)(A)). “‘The court’s responsibility is narrow[]: to 18 determine whether the’ agency complied with the procedural 19 requirements of the APA.” Id. (quoting River Runners for 20 Wilderness v. Martin, 593 F.3d 1064, 1070 (9th Cir. 2010)). A 21 court will therefore “‘sustain an agency action if the agency has 22 articulated a rational connection between the facts found and the 23 conclusions made.’” Id. (quoting Pac. Coast Fed’n of Fishermen’s 24 Ass’ns v. U.S. Bureau of Reclamation, 426 F.3d 1082, 1090 (9th
25 6 Even if economic harm could support a finding of irreparable harm, plaintiffs do not provide any evidence in 26 support of their conclusory allegations that their costs will 27 increase. While plaintiffs don’t need to provide the exact costs they expect to incur, the court expects more than the vague 28 generalizations presented here. 1 Cir. 2005). “[T]raditional deference to the agency is at its 2 highest where a court is reviewing an agency action that required 3 a high level of technical expertise.” Id. (citing Marsh v. 4 Oregon Nat. Res. Council, 490 U.S. 360, 377 (1989)) (additional 5 citation omitted); see Edison Elec., 391 F.3d at 1270 (a court 6 must give deference to the EPA “when it evaluates ‘scientific 7 data within its technical expertise.’”) (quoting City of Waukesha 8 v. EPA, 320 F.3d 228, 247 (D.C. Cir. 2003)). 9 As explained above, plaintiffs challenge defendants’ 10 approval of the State Water Board’s requirement of the TST. 11 “States have the primary role, under § 303 of the [Clean Water 12 Act], 33 U.S.C. § 1313, in establishing water quality standards. 13 EPA’s sole function, in this respect, is to review those 14 standards for approval.” Am. Wildlands v. Browner, 260 F.3d 15 1192, 1194 (10th Cir. 2001) (citations and internal quotations 16 omitted); see also 33 U.S.C. § 1251(b) (“It is the policy of the 17 Congress to recognize, preserve, and protect the primary 18 responsibilities and rights of States to prevent, reduce, and 19 eliminate pollution . . . .”). 20 Thus, the EPA’s role in approving state water quality 21 standards “is limited.” See id.; see also NRDC v. EPA, 16 F.3d 22 1395, 1399 (4th Cir. 1993) (“EPA sits in a reviewing capacity of 23 the state-implemented standards, with approval and rejection 24 powers only.”); Barnum Timber Co. v. EPA, 835 F. Supp. 2d 773, 25 780-81 (N.D. Cal. 2011) (the Ninth Circuit “has taken a similar 26 position” to NRDC “with respect to a state’s role in the 27 process”) (citing City of Arcadia v. EPA, 411 F.3d 1103, 1106 28 (9th Cir. 2005)) (section 1313 is “consistent with the basic 1 goals and policies that underlie the Clean Water Act -- namely, 2 that states remain at the front line in combatting pollution”). 3 Under 40 C.F.R. § 131.5(a), the EPA must consider eight 4 factors when reviewing a state’s adopted water quality standards. 5 Here, plaintiffs claim defendants’ approval of the TST, as 6 mandated by the Toxicity Provisions, was arbitrary and capricious 7 because defendants’ review failed to consider two factors: (1) 8 applicable legal procedures; and (2) sound scientific rationale. 9 (See generally Mot.) 10 Below, the court will first address whether the State 11 Water Board followed applicable legal procedures before 12 addressing whether the State Water Board’s criteria was based on 13 sound scientific rationale. 14 1. Applicable Legal Procedures 15 Under 40 C.F.R. § 131.5(a)(6), defendants must consider 16 “[w]hether [California] has followed applicable legal procedures 17 for revising or adopting standards.” Plaintiffs argue that 18 defendants’ review did not comply with 40 C.F.R. § 131.5(a)(6) 19 because: (1) defendants “failed to . . . confirm that the State 20 Water Board followed appropriate legal procedures when drafting 21 the Toxicity Provisions”; and (2) “the State Water Board abused 22 its rulemaking discretion when it drafted the Toxicity Provisions 23 relying on EPA guidance rather than final, promulgated rules.” 24 (Mot. at 23.) On the record before the court, both arguments are 25 without merit. 26 First, as described in the EPA Approval, “California’s 27 development of its new [water quality standards] regarding 28 toxicity included opportunities for public input at more than 1 three dozen meetings throughout the State since 2012. California 2 solicited public comments and prepared responses to those 3 comments on October 26, 2018; July 22, 2020; and September 30, 4 2021.” (EPA Approval at 20.) Further, the California Attorney 5 General certified that the Toxicity Provisions were adopted 6 pursuant to California law. (Id.) 7 Second, although EPA regulations do not list the TST as 8 a method of statistical analysis, the regulations expressly 9 provide that the listed methods are “not the only possible 10 methods of statistical analysis.” 67 Fed. Reg. 69964. Moreover, 11 the State Water Board’s reliance on the EPA’s non-binding 12 guidance is precisely how states are supposed to revise their 13 water quality standards. See Sanitary Bd. of City of Charleston, 14 W.Va. v. Wheeler, 918 F.3d 324, 328 (4th Cir. 2019) (“Apart from 15 its oversight and approval role, the EPA also develops guidance . 16 . . which states in turn rely on in evaluating and updating their 17 standards.”). 18 The only thing plaintiffs point to as evidence that the 19 State Water Board did not follow applicable legal procedures is 20 its decision to rely on EPA guidance documents, as opposed to 21 promulgated rules, when adopting the TST as the required method 22 of statistical analysis for WET tests. However, as discussed 23 above, it was well within the State Water Board’s discretion to 24 do rely on EPA guidance documents. The court therefore finds 25 nothing in the record which would suggest that the State Water 26 Board did not follow the applicable legal procedures when 27 adopting the Toxicity Provisions. For the foregoing reasons, the 28 court finds defendants followed applicable legal procedures when 1 they approved the Toxicity Provisions. 2 2. Sound Scientific Rationale 3 Under 40 C.F.R. § 131.5(a)(2), defendants must consider 4 “[w]hether [California] has adopted criteria that protect the 5 designated water uses based on sound scientific rationale 6 consistent with § 131.11.” 7 In their approval of the Toxicity Provisions, 8 defendants explained that they “considered the scientific 9 justification included in the submittal supporting document and 10 also reviewed EPA Technical Documents and additional peer- 11 reviewed science.” (EPA Approval at 26.) The peer-reviewed 12 literature describes that the TST “provides greater confidence 13 that truly non-toxic water samples are identified as non-toxic 14 and truly toxic water samples are identified as toxic,” “reduces 15 the likelihood of missing true toxicity when it occurs (false 16 negative), and “reduces the likelihood of declaring a sample 17 toxic when there is a biologically insignificant effect (false 18 positive result).” (Id. at 27.) Defendants also explained that 19 the type of hypothesis testing upon which the TST is based “has 20 long been used in many contexts, from evaluating clinical trials 21 of pharmaceutical products, to evaluating the attainment of soil 22 cleanup standards from contaminated sites, to evaluating the 23 effects of pesticides in experimental ponds.” (Id. at 26.) 24 Conversely, plaintiffs argue that the TST does not 25 constitute sound scientific rationale because TST test results 26 differ from promulgated testing methods and “can have a false 27 indication of toxicity rate of over 50 percent.” (Compl. ¶ 61; 28 Mot. at 21.) Plaintiffs do not cite any technical study or peer- 1 reviewed research in support of this position in either their 2 Complaint or Motion. In their Reply, plaintiffs cite a white 3 paper (the “CASA White Paper”), which they contend shows that the 4 TST has a high risk of false positives. (Reply at 11; see 5 Hamilton Decl., Ex. A (“CASA White Paper”) (Docket No. 30-1).) 6 However, as defendants correctly point out, the CASA White Paper 7 is not a peer-reviewed study and focuses on only one of the many 8 aquatic toxicity test methods approved under EPA regulations. 9 (See Surreply at 4-5 (Docket No. 33).) Further, the CASA White 10 Paper was submitted to the State Water Board by an interested 11 party (the California Association of Sanitation Agencies) during 12 the notice and comment for the Toxicity Provisions. (See 13 generally CASA White Paper.) 14 Plaintiffs also argue that “[s]tandards where the water 15 is presumed to be toxic cannot logically protect the aquatic life 16 uses -- they would all be dead.” (Mot. at 21.) This argument is 17 nonsensical. The TST is a method of statistical analysis. The 18 TST uses a null hypothesis that the sample water is toxic. (Id. 19 at 27.) The TST method’s presumption of toxicity is an 20 analytical hypothesis, not a factual statement that all water is 21 in fact toxic. Moreover, it does not follow that an analytical 22 hypothesis which presumes water toxicity means that all aquatic 23 life is dead. 24 There is nothing in the EPA Approval to support the 25 claim that the TST, as adopted in the Toxicity Provisions, is not 26 based on “sound scientific rationale.” Cf. San Luis, 776 F.3d at 27 9940 (“[T]raditional deference to the agency is at its highest 28 where a court is reviewing an agency action that required a high ee IIE IED REI I EOE IIE IN IES II IO
1 level of technical expertise.”); Ctr. for Regul. Reasonableness 2] v. EPA, No. 16-cv-1435, 2019 WL 1440303, at *10 (D. D.C. Mar. 31, 3 2019) (describing a case involving EPA’s approval of a state’s 4 water quality criteria as “a classic example of a case warranting 5 | deference to EPA on scientific and technical matters within its 6 sphere of expertise”). Therefore, on the record before the 7 court, defendants properly considered whether California’s 8 adoption of the TST was based on sound scientific rationale. 9 For the foregoing reasons, the court finds that 10 defendants reviewed the Toxicity Provisions consistent with 40 11 C.F.R. § 131.5(a). Defendants’ approval of the Toxicity 12 Provisions was therefore not arbitrary and capricious. See 5 13 U.S.C. §$ 706(2) (A). 14 TILT. CONCLUSION 15 Because plaintiffs have failed to show that they are 16 likely to suffer irreparable harm or are likely to succeed on the 17 merits, plaintiffs’ motion for a preliminary injunction must be 18 denied. See A Woman’s Friend Pregnancy Res. Clinic, 901 F.3d at 19 1167 (plaintiffs “must make a showing on all four prongs to 20 obtain a preliminary injunction”) (quotation marks and citations 21 omitted) . 22 IT IS THEREFORE ORDERED that plaintiffs’ motion for 23 | preliminary injunction (Docket No. 15) be, and the same hereby 24 | is, DENIED. . : ak. ah thea (LA. 25 Dated: August 7, 2023 WILLIAMB.SHUBB © 26 UNITED STATES DISTRICT JUDGE 27 28 14