Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 1 of 39 PageID 22575 IN THE UNITED, STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON - Plaintiffs, CIVIL ACTION NO.: (Consolidated with Case No. 2:14?11011; Case No. 2:14?13164; Case No. 2:14-? 13454) HON. JOHN T. COPENHAVER AMERICAN WATER WORKS COMPANY, et. (11., Defendants. DEFENDANT EASTMAN CHEMICAL OPPOSITION TO PLAINTIFF MOTION FOR SUMMARY JUDGMENT ON THE ISSUE OF DEFENDANT COMPLIANCE WITH THE TOXIC SUBSTANCES CONTROL ACT Case 2:14-cv-01374 Document 821 - Filed 06/03/16 Page 2 of 39 PageID 22576 TABLE OF CONTENTS Page INTRODUCTION .. 1 ARGUMENT AND AUTHORITIES ..2 1. Summary Judgment Standard ..2 II. Plaintiffs? Lack Authorization And Standing To Assert TSCA Claims. .. 3 TSCA Overview ..6 IV. Plaintiffs Lack An Actionable Claim Under ..7 A. Section 8(e) does not require reporting studies that do not ?reasonably support a conclusion of substantial risk of injury to health or the environment. . . 8 l. Eastman animal studies do not demonstrate a substantial risk of injury to human health .. 10 a. Skin irritation ?findings? do not require reporting under .. 11 b. Skin sensitization ?findings? do not require reporting under .. 13 c. Hyperemia ?findings? are not appropriate for reporting under .. 13 d. Hematuria ?findings? are not appropriate for reporting under .., 14 e. Other ?health effects? are not a substantial risk under .. l7 2. MCHM aquatic toxicology studies do not demonstrate a substantial risk of injury to human health or the environment under .. 18 3. PowerPoints and articles regarding five public health studies do not reasonably support a conclusion of substantial risk to human health under .. 19 4, Water monitoring and odor studies do not indicate a substantial risk under .. 21 i Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 3 of 39 PageID 22577 B. Exemptions from the reporting requirement of 8(e) .. 21 l. The 22 studies are exempt because of EPA awareness of the studies. .. 21 2. NTP studies are exempt from reporting under .. 23 3. Public health studies are exempt from reporting under .. 25 V. Plaintiffs Lack An Actionable Claim Under 5 For Purported Deficiencies In Eastman?s 1997 Premanufacture Notice. .. 25 VI. Plaintiffs Lack An Actionable Claim Regarding .. 28 CONCLUSION .f ., .. 31 ii Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 4 of 39 PageID 22578 TABLE OF AUTHORITIES Page(s) Cases 3M Co. v. Browner, 17 F.3d 1453 (DC. Cir. 1994) .. 25 Anderson v. Liberty Lobby, Inc. 477 US. 242 (1986) ..2 Arch Mineral Corp. v. Babbitt, 104 F.3d 660 (4th Cir. 1997) .. 25 Bodne v. Geo A. Rheman Co., Inc, 811 F. Supp. 218 (D.S.C. 1993) .. 25 Carellus Dev. Corp. v. L.D. McFarland C0., 910 F. Supp. 1509 (D. Or. 1995) .. .. 25 Friends of the Earth, Inc. v. Gaston Copper Recycling Corp. 629 F.3d 387 (4th Cir. 2011) .. 3, 4 Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (T 0C), Inc. 528 US. 167 (US. 2000) ..4 Friends for Ferrell Parkway v. Stasko, 282 F.3d 315 (4th Cir. 2002) ..5 Gwaltney of Smith?eld v. Chesapeake Bay Found, 7 484 US. 49 (US. 1987) ..4 In re Elementis Chromium, 2015 EPA App. LEXIS 5, Mar. 13, 2015) .. 8, 2O Lujan v. Defenders of Wildlife, 504 US. 555 (US. 1992) .. ..4 Mair v. City of Albany, 303 F. Supp. 2d 237 (N.D.N.Y 2004) Nat?l Parks Conservation Ass Inc. v. Tenn. Valley Auth, I 502 F.3d 1316 (11th Cir. 2007) .. 25 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 5 of 39 PageID 22579 Pender v. Bank of Am. Corp, 788 F.3d 354 (4th Cir. 2015) ..5 Purepac Pharm. Co. 12. Thompson, 354 F.3d 877 (DC. Cir. 2004) .. 28 Spokeo v. Robins, 578 U.S. Slip 0p. at 10 (May 16, 2016) .. ..4 Steel Co. v. Citizens for a Better Env?t, 523 U.S. 83 (U.S. 1998) .. 4, 5, 6 United States v. Diebold, Inc, 369 U.S. 654 (1962) ..2 United States v. Potomac Navigation, Inc. i I 2009 U.S. Dist. LEXIS 51484 (D. Md. Apr. 29, 2009) ..4 White v. Dow Chem. Co. 2007 US. Dist. LEXIS 98915 (SD. W. Va. Nov. 29, 2007) ..3 Statutes 15 ..1, 25 15 U.S.C. 2605 .. 26 15 U.S.C. 2607 ..1, 8, 27, 28 15 U.S.C. ?2614 .. 1, 3 15 U.S.C. 2619 .. 3, 4 18 U.S.C. 3571 ..6 28 U.S.C. ..25 33 U.S.C. 1319 ..6 33 U.S.C. 1365 .. ..3 Other Authorities 40 C.F.R. 717 .. 28 43 Fed. Reg. 11110, et seq. .. 7, 9, 19 56 Fed. Reg. 28458 ..7 iv Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 6 of 39 PageID 22580 68 Fed. Reg. 33129, 61? seqFed. Reg. 2162, et seq. ..7 72 Fed. Reg. 3432, at seq. Fed. R. Civ. P. 56(3) .., ..2 US. Const., Art. 111, e1. 1 ..4 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 7 of 39 PageID 22581 INTRODUCTION Plaintiffs? Motion for Partial Summary Judgment and Memorandum of Law in Support on the Issue of Defendant Eastman?s Compliance with the Toxic Substances Control Act allege that Eastman violated 15 U.S.C 2604 (TSCA 5), 2607 (TSCA 8),1 and 2614(3)(b) (TSCA 15).2 Under the citizen suit provision of TSCA, Plaintiffs seek injunctive relief on the TSCA claims in their Complaint.3 Yet the only TSCA violations alleged in the Complaint, and the only claims for which Plaintiffs have given statutorily required notice to the EPA, are 8(e) claims. Plaintiffs? pursuit of injunctive reliefrequests af?rmative actions even the EPA'lacks the authority to demand under TS CA, seeking to order Eastman: to submit to EPA numerous reports and studies (which EPA already has) under TSCA (2) to withdraw its 1997 TSCA ?5 Premanufacturing Notice and resubmit it with the various studies and other information which Plaintiffs want Eastman to submit under and, (3) record and place on file third party reports related to the January 9, 2014 Freedom Elk River spill as if they were allegations of adverse health effects subject to TSCA 8(0) recordkeeping requirements. Plaintiffs lack statutory standing to pursue these claims and have set forth no basis on which the Court can find they have standing under Article Plaintiffs also have set forth no evidence much less undisputed evidence to demonstrate Eastman has not complied with TS reporting and recordkeeping requirements regarding the submission of a chemical Premanufacture Notice under 5, internal 8(0) records of reports individuals make regarding chemical contact, and reports demonstrating ?a substantial risk of injury to health or the environment? under Critically, Plaintiffs cannot demonstrate that the MCHM studies, reports and other information they cite meet the ?substantial risk? 1 Plfs.? Mem. 1. TSCA 5 is attached as EX. A. TSCA 8 is attached as Ex. B. 2 Plfs.? Mem. 5. 15 U.S.C. ?2614(3)(b) is attached as EX. c. 3 These claims can be found in Count Twenty?one of Plaintiffs? First Amended Consolidated Class Action Complaint. Dkt. 170,111] 305?322. Case 2:14-cv701374 Document 821 Filed 06/03/16 Page 8 of 39 PageID 22582 threshold of TSCA Instead, Plaintiffs? have cobbled together a theory regarding substantial risk which rests entirely. on the ipse dixit conclusory opinions of their experts, including Robert Sussman a lawyer with no training or expertise in interpreting toxicology studies that various studies ?reasonably support the conclusion that [crude presents a substantial risk.? At the same time, Plaintiffs overlook the various reporting exemptions that apply directly to Eastman and to the various studies and other information involved here. Plaintiffs also neglect to acknowledge that EPA was fully informed immediately after the 2014 Elk River spill of the Eastman studies which Plaintiffs claim should have been submitted, exempting them from reporting. What is more, Plaintiffs ignore the I fact that in the twenty months since their counsel notified the EPA of some of the very TSCA violations alleged in this suit, the EPA has taken no. action. This court, too, should ?nd merit lacking in Plaintiffs? legally and factually insufficient claims, and deny Plaintiffs? motion for summary judgment. ARGUMENT AND AUTHORITIES I. Summary Judgment Standard summary judgment is appropriate only ?if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.? FED. R. CIV. P. 56(a). A genuine issue of material fact exists if, in Viewing the record and all reasonable inferences drawn therefrom in a light most favorable to the non?moving party, a reasonable fact finder could return a verdict for the non?movant. Anderson v. Liberty Lobby, Inc, 477 US. 242, 248 (1986). Inferences that are ?drawn from the underlying facts . . . must be viewed in the light most favorable to the party opposing the motion.? United States v. Diebeld, Inc, 369 US. 654, 655 (1962). Summary judgment is justified by failure to make a ?showing sufficient to establish the existence of an element essential to the party?s case and on Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 9 of 39 PageID 22583 which that party will bear the burden of proof.? White v. Dow Chem. Co., 2007 US. Dist. LEXIS 98915 (S.D. W. Va. Nov. 29, 2007). II. Plaintiffs? Lack Authorization And Standing To Assert TSCA Claims. TSCA claims in both Plaintiffs? Complaint and Plaintiffs? Motion are brought pursuant to the citizen suit provision of TSCA.4 Because their claims are not authorized by TSCA, Plaintiffs lack statutory standing. Citizen suits under environmental statutes are limited to violations identi?ed in the EPA notice letter. Friends of the Earth, Inc. v. Gaston Copper Recycling Corp, 629 F.3d 387, 400 (4th Cir. 2011) (?the sufficiency of the plaintiffs? notice letter, at its core, presents a legal defense to the plaintiffs? claim?) (reviewing an identical notice requirement5 in the Clean Water Act). The EPA notice letter here raised no issue with Eastman?s PMN (TSCA nor reporting requirements under TSCA Just as in the notice letter, the only violations of TSCA alleged in Count Twenty-one of Plaintiffs? Complaint are under TSCA Therefore any claim based on 5 and 8(0) are not only unwarranted for summary judgment, but are actually barred altogether because statutory standing is lacking. See Friends of the Earth, 629 F.3d at 401. Second, the relief Plaintiffs seek an order compelling8 Eastman to act is not authorized by TSCA in a private-citizen suit. The only relief available to Plaintiffs is ?to 4 15 U.S.C 2619(a)(l), which provides that ?any person may commence a civil action. . . against any person who is alleged to be in violation of this chapter . . . to restrain such violation.? (emphasis added). Compare 15 U.S.C. ?2619(b)(1)(A) with 33 U.S.C. 1365(b)(1)(A). 6 See Letter from Kevin Thompson, Counsel for Plaintiffs, to Regina McCarthy, Administrator, EPA (Sept. 3, 2014). Attached as EX. D. These claims are presented either directly or derivativer through 15 U.S.C. 2614(3)(b) which provides that: ?It shall be unlaw?il for any person to? fail or refuso to submit reports, notices, or other information . . . as required by this chapter or a rule thereunder.? I 8 Plaintiffs? summary judgment motion prays for an order which would require Eastman (1) to submit to EPA numerous rep01ts and studies (which EPA already has) under TSCA (2) to withdraw its 1997 TSCA ?5 Premanufacturing Notice and resubmit it with the various studies and other information which Plaintiffs want Eastman to submit under and, regard and place on ?le third party reports related to the January 9, 2014 Freedom Elk River spill as if they were atlegations of adverse health effects subject to TSCA 8(0) recordkeeping requirements. Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 10 of 39 PageID 22584 restrain? current violations of TSCA.9 Plaintiffs do not seek to ?restrain? alleged violations of TSCA, but rather seek an order requiring Eastman to af?rmatively act. Mair v. City of Albany, 303 F. Supp. 2d 237, 243 (N.D.N.Y 2004) (?Ordering defendants back tothe homes Where abatement activity has ceased, to do more work, would not be a restraint or a stoppage; it would be ordering an affirmative act?); United States v. Potomac Navigation, Inc., 2009 U.S. Dist. LEXIS 51484 (D. Md. Apr. 29, 2009) (?Citizen suits under TSCA cannot be brought for compensatory damages or ?recovery,? but only to restrain current violations. Because there is no current conduct on the part of Third Party Defendants that could be restrained, there can be no claim against them under To bring suit in federal court, Plaintiffs must also demonstrate Article standing10 in addition to statutory standing. Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc, 528 U.S. 167, 181 (U.S. 2000) (applying Article standing analysis to similar citizen suit provision in Clean Water Act).11 To have standing, Plaintiffs must show they (1) suffered an injury in fact that is actual and imminent, (2) that is fairly traceable to the defendant?s action and not the result of some third party not before the court and (3) the injury must likely be redressed if the plaintiff prevails in the lawsuit. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560 (U.S. 1992). Plaintiffs? lack standing here because the injuries complained of are not fairly traceable to Eastman?s alleged TS CA violations and the relief sought by Plaintiffs cannot redress any injury. As the Supreme Court recently explained in Spokeo v. Robins, class action plaintiffs ?cannot satisfy the demands of Article by alleging a bare procedural violation? of a statute. 9 15 U.S.C. 2619; See Gwaltney of Smith?eld v. Chesapeake Bay Formal, 484 U.S. 49, 64 (U .8. ?987) (hoiding similar language in the Clean Water Act did not allow suits based on past Violations); See also United States v. Potomac Navigation, Inc, 2009 U.S. Dist. LEXIS 51484 (D. Md. Apr. 29, 2009). 10 Here the terms Article standing and constitutional standing are used interchangeably to describe the standing limits embodied by the case or controversy ciause in U.S. Const, Art. 2, cl. 1. 11 See also Friends of the Earth, Inc. v. Gaston Copper Recycling Corp, 629 F.3d 387, 390 (4th Cir. 2011) (Clean Water Act) and Steel Co. v. Citizens for a'Better Env?t, 523 U.S. 83, 86 (U.S. 1998) (applying Article standing analysis to a similar citizen suit provision in the EPCRA). 4 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 11 of 39 PageID 22585 578 US. Slip op. at 10 (May 16, 2016). That ruling applies here, where class plaintiffs have alleged no concrete economic loss or injury that stems from purported violations of reporting and recordkeeping requirements under TSCA. Plaintiffs? constitutional standing is predicated solely on the theory of speculative injuries from Eastman?s TSCA violations allegedly compromising ?government officials and the scientific community [being] fully able to evaluate the spill?s impacts on public health.?12 Plaintiffs allege 110 injuries in this case caused by or fairly traceable to Eastman?s alleged TSCA violations. A single Plaintiff?s speculation ?that it faces the potential for a long-term decrease in revenue because of the continuing effect on consumer confidence in the local water supply? does not rise to the level of a concrete harm, is only a harm particularized to one person, and is not traceable to Eastman?s alleged TSCA Violations. Freedom, not Eastman, discharged the chemical into the Elk River. Friends for Ferrell Parkway v. Stasko, 282 F.3d 315, 320 (4th Cir. 2002) (?The traceability requirement ensures that it is likely the plaintiff?s injury was caused by the challenged conduct of the defendant, and not by the independent actions of third parties not before the court?). Moreover, Plaintiffs? proposed relief cannot redress any injury real or speculative - to Plaintiffs. Ordering Eastman to disclose information under TSCA and ?5 will not redress any of Plaintiffs? alleged injuries. Steel Cal, 523 US. at 107. (?Relief that does not remedy the injury suffered cannot bootstrap a plaintiff into federal court; that is the very essence of the redressability requirement?). Plaintiffs do not have standing and their TSCA claims should be dismissed. Finally, in addition to failing to establish constitutional Standing, all of the information which Plaintiffs seek to have this Court order Eastman to disclose is known to EPA and the ?2 Plfs.? Mem. 6. See also PIfs.? Compl. 320?321. Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 12 of 39 PageID 22586 public and the issue is moot. Fender v. Bank of Am. Corp, 788 F.3d 354, 367-368 (4th Cir. 2015) (?If a live case or controversy ceases to exist after a suit has been filed, the case will be deemed moot and dismissed for lack of standing?) In sum, not only are Plaintiffs not entitled to summary judgment on their TSCA claims, these claims, in fact, should be dismissed for lack of standing. The absence of standing, regardless of the stage in litigation at which it is raised, warrants dismissal. See Steel C0., 523 US. at 89. Overview As part of the federal environmental legislative reform of the 1970s, Congress enacted TSCA to screen new chemicals for toxic effects before they could be commercialized. In contrast to the penalties provided under pollution control statutes,13 function was to prospectively assess the risks of chemicals before they were in Widespread use.14 TSCA was not intended, as Plaintiffs seek, to permit litigants to second-guess decision to allow a chemical?s commercialization decades after the fact. Plaintiffs allege three types of TSCA violations: (1) Eastman failed to submit 22 studies or reports to EPA which Plaintiffs argue required reporting under Dkt. 729, Plfs.? Mem. 6?25. (2) Eastman?s Premanufacture Notice submitted in October 1997 on a constituent of crude MCHM (which EPA reviewed and approved), did not comply with 5 of TSCA. Id. at 25?27. (3) Plaintiffs claim that Eastman violated internal company record-keeping provisions of Id. at 28-29. Plaintiffs? motion seeks an injunction requesting the Court to: 0 Direct Eastman to submit the, 22 reports and studies to 8(e) docket in 15 days; 2 13 See ag, 33 U.S.C. 1319 (Clean Water Act penalties); l8 UJSC. 3571 (Clean Air Act penalties). 14 David Markell, An Overview of TSCA, Its History and Key Underlying Assumptions, and Its Place in Environmental Regulation, 32 Wash. U. .L. Pol?y 333, 345 (2010). See also Council on Environmental Quaiity, Environmental Quaiity: The Eighth Annual Report of the Council on Environmental Quality 5 (1977) (?The new public policy expressed in the law is that manufacturers of chemicals have an obligation to test product safety and that government has the authority to regulate potentially dangerous chemicals and to take immediate action on those that are an imminent hazard?). Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 13 of 39 PageID 22587 - Require Eastman to Withdraw its 1997 PMN and resubmit it with all available data on crude and pure MCHM and a full and complete description of exposure and release at user sites; 0 Require Eastman to maintain in its ?le under 8(c) records of all known reports of adverse health effects relating to the January 9, 2014 spill of MCHM into the Elk River. IV. Plaintiffs Lack An Actionable Claim Under Section 8(e) requires that manufacturers and distributors of chemicals who obtain information Which ?reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment? must inform EPA ?unless such person has actual knowledge that the Administrator has been adequately informed .of such information.? Although When TS CA became effective in 1976, scant, information existed regarding its practical application, EPA has issued explanations in various guidance documents in the decades since. :5 EPA ?nalized its 8(e) ?policy statemen on March 16, 1978.16 EPA later published a 8(e) reporting guide (?1991 EPA 8(e) Reporting Guide?). 56 Fed. Reg. 28458 (June 20, 1991); Dkt. 777, Ex. 2. EPA issued this commentary on 8(e) applicability for a number of toxicological case studies to help companies better understand the kind of information that should be reported. The most recent EPA guidancel7 Section Noti?cation of Substantial Risk; 3918 Policy Clari?cation and Reporting Guidance, revised previous guidance.? In 2005, some of 15 Section 8(e) was ?self?implementing? the statute became effective without EPA regulations. 16 Statement of Interpretation and Enforcement Policy; Noti?cation of Substantial Risk, 43 Fed. Reg. 11110 (?1978 EPA 8(e) Policy Statement?), Dkt. 777, Plfs.? Mem., Ex. 3. 17 A guidance document provides ?an agency statement of general applicability and future effect . . . that sets forth a policy on a statutory, regulatory or technical issue or an interpretation of a statutory or regulatory issue.? Final Bulletin for Agency Good Guidance Practices, 72 Fed. Reg. 3432, 3439 (Jan. 25, 2007). 18 68 Fed. Reg. 33129 (June 2, 2003) (?2003 EPA 8(e) Guidance?), Dkt. 777,P1fs. Mem, Ex. 5. i9 EPA republished ?the policy statement in its entirety . . . including both those portions of the policy statement that are-revised and those portions that are not affected by any revisions,? id. at 33129, because it ?hopes and expects that this guidance will be useful to manufacturers, including importers, processors, and distributers [sic] of chemical substances in ful?lling their responsibilities under section This guidance is not, however, a substitute for rulemaking and it does not impose any binding requirements upon either the regulated community or the Agency.? Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 14 of 39 PageID 22588 the changes that the 2003 EPA 8(e) Guidance made to the 1978 EPA 8(e) Policy Statement were corrected and EPA simultaneously announced new Question Answer Guidance.20 As provided for in the 2003 EPA 8(e) Guidance, the website has updated its Question Answer Guidance three times: in January 2005, September 2006, and January 2010.21 These Question Answer Guidance website postings provide practical instruction useful to companies for determining their reporting obligations under A. Section 8(e) does not require reporting studies that do not ?reasonably support a conclusion of substantial risk of injury to health or the environment.? None of the 22 studies cited by Plaintiffs are required to be reported because they do not reasonably support a ?nding of a substantial risk of injury, as they must. Plaintiffs? unsupported interpretation of the incidental observations in the studies here resembles the speculation about potential risk that was held to not ?reasonably support? substantial risk ?ndings in In re Elementis Chromium, 2015 EPA App. LEXIS 5, 97-99 (EPA Mar. 13, 2015): Information must not just ?support? a conclusion of substantial risk of injury, it must ?reasonably? support the conclusion. The modi?er ?reasonably? mandates a degree of certainty for identifying the supporting information that must be reported. Information regarding substantial risk of injury must not be speculative in nature; rather, as guidance notes, it should ?reliably ascribe the effect to the chemical.? To disregard this EPA standard and allow speculation to support substantial risk ?ndings would expand the reporting requirements beyond the intent and reach permitted by Neither TSCA nor its legislative history de?ne what constitutes a ?substantial risk of injury to health or the environment.? 15 U.S.C. ?2607(e). Together, the EPA Guidance Id. at 33130?31 (emphasis added). The 2003 EPA Guidance also explains that the agency planned to: ?develop . . . a ?question and answer" . . . document that would provide further detail and ?real world? examples to further assist persons in ful?lling their section 8(e) reporting responsibilities . . . Id. at 33133. 29 TSCA Section 8(e) Reporting Guidance; Correction, Clari?cation of Applicability, and Announcement Regarding the Issuance Questions and Answers, 70 Fed. Reg. 2162?64 (Jan. 12, 2005). 21 EPA, Toxic Substance [sic] Control Act (TSCA) Section 8(e) Notices, This Question Answer Guidance is attached as EX. E. 8 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 15 of 39 PageID 22589 documents and Question Answer Guidancefrom EPA provides signi?cant insight regarding what constitutes a ?substantial risk.? The 1978 EPA 8(e) Policy Statement presented a two- pronged approach for determining ?substantial risk? by weighing human health effects and exposure.22 The ?rst criterion for reporting is a ?nding of human health effects including either of the following:? (1) Any instance of cancer, birth defects, mutagenicity, death, or serious or prolonged incapacitation, including the loss of or inability to use a normal bodily function with a consequent relatively serious impairment of normal activities, if one (or a few) chemical(s) is strongly implicated. (2) Any pattern of effects or evidence which reasonably supports the conclusion that the chemical substance or mixture can produce cancer, mutation, birth defects or toxic effects resulting in death, or serious or prolonged incapacitation. Id. at 11112. For the second criterion, exposure factors, the Policy Statement provides: Both hazard and exposure must occur for there to be any risk. If there is virtually no exposure, EPA will be unable to conclude that the chemical may present an unreasonable risk. 23 Within this framework, Plaintiffs argue various MCHM studies are required to be reported under 8(e) because: (1) Plaintiffs claim signi?cant health risks are associated with MCHM, and (2) the Freedom Industries spill increased the chemical?s exposure to a level requiring reporting. Both of these arguments are incorrect. Plaintiffs fail to show that MCHM poses a substantial risk to human health. Decades of animal testing revealed that MCHM posed none of the substantial risks to human health listed 22 43 Fed. Reg. 11111. 23 Similar to the two?pronged approach of the 1978 EPA 8(e) Policy Statement for ?substantial risk,? the 1991' 1 EPA 8(e) Guidance similarly provides for balancing the factors: In deciding whether information is ?substantial risk? information, one must consider 1) the seriousness of the adverse effect, and 2) the fact or probability of the effect?s occurrence. In determining TSCA Section 8(e) [sic], these two criteria should be weighted differently depending upon the seriousness of the effect or the extent of the exposure, the more serious the effect, the less heavily one should weigh actual or potential exposure, and Vice versa. Id. at 2. Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 16 of 39 PageID 22590 above cancer, birth defects) typically justifying reporting. Likewise, Plaintiffs? do not rise to the level of these substantial risks. See Dkt. 170, Compl. 5?7. I Also, EPA guidance makes clear exposure for purposes of 8(e) reporting is calculated24 based on potential exposure associated with its intended use such as with commercialization,25 or upon discovery of previously extant but unknown exposure.26 Plaintiffs point to no authority for their position that exposure should, or even can, be determined by the risk of improper discharge or improbable release by other parties, or that it meets the standard for widespread use.? Also, Plaintiffs do not identify any instances when EPA has gone so far to determine ex postfacto that. a release caused by a third party places a chemical manufacturer in violation of reporting requirement, or any basis for making such an extension of Because Plaintiffs can point to no factual support to satisfy the ?substantial risk? criteria under the 2003 EPA 8(e) Guidance, summary judgment on their claims would be inappropriate. A 1. Eastman animal studies do not demonstrate a substantial risk of injury to human health. - Plaintiffs? Motion alleges that findings from seven studies performed by Kodak on behalf of Eastman should have been reported under TSCA The findings which Plaintiffs claim 24 Similar to the 1991 EPA 8(a) Reporting Guide, the 2003 EPA 8(e) Guidance ties exposure potential to typical commercial activities: ?production levels, persistence, uses, means of disposal, or other pertinent factors.? Id. at 33138. 25 Letter from Victor Kimm, Deputy Assistant Administrator, EPA, to Robert Sussman, Counsel for various chemical companies, Latham Watkins (Apr. 2, 1992). Attached as Ex. F. 26 See 2006 EPA 8(e) Question Answer Guidance at Q. A. 25. 27 To the contrary, evidence in the record suggests ?[t]he potential exposure of residents that occurred following the spill (if any occurred above measurable concentrations) was very low. Given this low exposure and the strong warning properties of Crude MCHM (its odor), the potential for toxicity to humans following the spill was very likely negligible.? Plfs.? Ex. 12, Rebuttal Opinion Letter of D. Paustenbach (Mar. 9, 2016). 28 The seven animal studies performed by Eastman Kodak Company, Rochester, New York which Plaintiffs I contend included findings required to be reported were: (1) Study on Basic Toxicity of Crude 4- Feb. 10,1977 (?1977 Basic Toxicology Study?); (2) Four?week Oral Toxicity Study of in the Rat (TX-89-296), Apr. 3, 1990 (?1990 Oral Study of Pure (3) Acute Toxicity of Jan. 26, 1990 (?1990 Acute Toxicity 10 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 17 of 39 PageID 22591 required reporting fall into several categories: (1) Skin imitation; (2) Skin sensitization; and, (3) ?serious toxic effects,? including hyperemia and hematuria and a variety of other Under TSCA, none of these ?ndings required reporting. a. Skin irritation ?findings? do not require reporting under Plaintiffs claim that Eastman?s animal toxicology studies demonstrated skin irritation which should have been reported.29 Plaintiffs are simply wrong. As a preliminary matter, EPA has repeatedly indicated that skin irritation findings are rarely reportable. EPA guidance30 notes: As stated in March 16, 1978 Section 8(e) policy statement, as Well as numerous SeCtion 8(e) ?status reports,? the Section 8(e) reportability of irritation and/0r corrosivity ?ndings from acute animal or skin irritation studies is quite limited. EPA provides31 for a possible exception to the general presumption of non-reportability only in limited circumstances: previously unknown or A unexpected effects that occur and are observed/determined during such routine tests may have to be submitted under Section 8(e) if the effects are serious and meet the reporting criteria outlined in Part of Section 8(e) policy statement lethality, neurotoxicity). First, Plaintiffs offer no basis for any exception to the normal rule that 8(e) does not require reporting unremarkable irritation ?ndings, except the conclusory opinions of their expert. Second, Plaintiffs overlook key differences in two similar-sounding, but dramatically differently designed toxicity tests. In a guideline skin (dermal) irritation study such 404, the test article (chemical) is applied for four hours under a light, ?semi-occluded? dressing, similar to a Study?); (4) Acute Dermal Irritation Study in the Rabbit (TX-97-256), NOV. 10, 1997 (?1997 Dermal Irritation Study?); (5) Acute Dermal Toxicity Study in the Rat 08), Feb. 24, 1998 and Acute Oral Toxicity Study in the Rat (TX-99-188), Dec. 1, 1999 (Two studies using different suppliers of lab rats SASCO and Charles River, collectively, ?1998?99 Sprague-Dawley Rat Studies?); and (6) A Two?Week Dermal Toxicity Study in the Rat 98-129), Jan. 6, 1999 (?1999 Two-week Dermal Toxicity Study?). 29 Plaintiffs? Motion alleges that skin irritation ?ndings in the following Eastman animal toxicology studies should have been reported under 1977 Basic Toxicology Study, 1990 Acute Toxicity Study, 1997 Dermal Irritation Study and 1999 Two?week Dermal Toxicity Study. 1991 EPA 8(e) Reporting Guide at 35. Id. 11 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 18 of 39 PageID 22592 gauze pad.32 By contrast, the protocol for acute dermal toxicity, OECD 402, because it is testing for systemic toxicity rather than skin irritation, involves applying the test article for twenty?four hours under an impervious dressing (?full occlusion?) that would be similar to a plastic sleeve, as was done in studies Plaintiffs claim should have been reported.33 As a result, constant contact with the test article during the period of the study at higher doses produces an exaggerated response in the skin compared to what would be expected with application for one-sixth of the time, that is, in a dermal irritation study. This exaggerated response is further magni?ed by the use of an impervious dressing compared to a semi-?occluded one. The potential reduction in expected irritatiOn severity diminishes the reportability under Crude MCHM is in a class of chemicals associated with the potential for skin irritation,35 and the study results did not deviate beyond that expectation. Plaintiffs seek to sidestep this problem by arguing ?ndings require reporting due to ?the potential for signi?cant exposure.? This is simply not true: there is no potential for signi?cant exposure, and the only potential for exposure comes from mishandling the chemical, which, as explained above, is not to be . considered. Moreover, even the mishandling by Freedom Industries in this case resulted in material being diluted to a level many orders of magnitude less than the doses used in any of the dermal irritation or toxicity studies. The dilution of even a moderately irritating substance in water at the dilution levels measured in the 2014 Freedom Industries release, falls yet further short from the reporting requirement threshold. Consistent with the EPA Guidance, just as 32 Test No. 404: Acute Dermal Imitation/Corrosion, OECD Guidelines for the Testing of Chemicals (July 28, 2015). x. 33 E. g, Acute Dermal Toxicity Study in the Rat, Eastman Chemical Company, Kingsport, TN (Feb. 24, 1998). 3? See 1991 EPA 8(e) Reporting Guide at 35. 35 Dennis Paustenbaoh, et al., The toxicity of crude (MCHM): review of experimental data and results of predictive models for its constituents and a putative metabolite, 45 Crit. Rev. Toxicol. Suppl. Suppl 2:1?55 (2015). 12 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 19 of 39 PageID 22593 countless ?ndings involving the common occurrence of skin irritation do not require reporting, neither did the ?ndings in Eastman?s skin irritation studies require reporting. b. Skin sensitization ?findings? do not require reporting under In recognition of the fact that in skin sensitization studies, ?the nature .of the reaction can vary from slight to severe,?36 the EPA directs companies to base their determinations of 8(e) reporting of test results on ?the severity of the response? and ?the number of animals affected.? Eastman?s decision not to report the 1977 Basic Toxicology Study is fully consistent with those criteria, as no animals displayed severe reactions. The majority of animals demonstrated no reactions at all, and the test substance barely met the lower boundary to be classi?ed as sensitizing. None of the extreme situations speci?ed in the Guidance were met by the test results death) and no 8(e) submission was required in 1977. Because the 1977 study did not support a ?nding of severe skin sensitization, and the 1997 study37 was also not sensitizing, reporting under 8(e) would not have been appropriate, either before or after the 2014 Freedom release. c. Hyperemia ?findings? are not appropriate for reporting under Hyperemia refers to an increase in blood ?ow to an organ, such as the skin. 38 For example, blushing is. a form of hyperemia. In a laboratory setting, it can refer to a test animal?s ears displaying pinkness. Plaintiffs label hyperemia a ?serious toxicological effect.? Hyperemia is not a toxicological effect, much less a serious one. Hyperemia is not even in the index of Casarett Doull?s Toxicology,39 the leading Toxicology treatise. It is an effect so'minor and commonplace that it does not warrant attention in other key texts as well.40 Even Plaintiffs? 36 1991 EPA 8(e) Reporting Guide at 35. 37 Acute Dermal Irritation Study in the Rabbit Nov. 10, 1997 (?i997 Dermal Irritation Study?). 38 Vinay Kumar, et a1., Robbins Cotran Pathologic Basis of Disease (8th ed. 2009). 39 Curtis Klaassen, et a1., Casarett Doull?s Toxicology: The Basic Science of Poisons (8th ed. 2013). 40 Wallace Hayes and Claire Kruger, Hayes? Principles and Methods of Toxicology (6th ed. 2014). 13 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 20 of 39 PageID 22594 toXicologist, Dr. King, was unwilling to state that hyperemia presents ?an injury to health,? labeling its occurrence merely ?an important ?nding.? Plfs.? Mem. 10, citing King Decl. at 1 (Ex. 9). There is no basis for Plaintiffs? claims that hyperemia should have been reported under Moreover, Plaintiffs? cite no EPA Guidance, EPA administrative opinions, or case law ?nding hyperemia to be ?an injury to health? that triggers reporting obligations under Plaintiffs merely cite to the unsupported z'pse dixiz? opinion of Mr. Sussman, a lawyer with no training in toxicology, that would likely deem hyperemia to be reportable, even if mild, because of the potential for signi?cant harm.? Plfs.? Mem. 10. For Plaintiffs to prevail on a motion for summary judgment, however, they must Show that as a matter of law, EPA requires reporting hyperemia under and that undisputed facts demonstrate that an actual reporting threshold was met by the study results. Plaintiffs admit that they can show nothing of the sort, contending only that the EPA would be ?likely? to require reporting hyperemia. Because Plaintiffs cannot point to actual hyperemia study ?ndings triggering a reporting obligation, Plaintiffs claim that the reporting requirement threshold would be met hypothetically if a study were conducted with ?longer exposure or under different dosing conditions?? Plaintiffs fall short of meeting their burden on summary judgment to show hyperemia presents a ?substantial risk of injury to healt d. Hematuria ?findings? are not appropriate for reporting under Plaintiffs claim that Eastman should have ?led 8(e) reports regarding three Eastman rat studies42 in the late 1990s that they claim documented hematuria, or blood in the urine. Plaintiffs 41 Plfs.? Meni. 10 (citing Sussman Rebuttal Declaration at 11 ll). 42 These studies include Acute Dermal Toxicity Study in the Rat, Eastman Chemical Company, Kingsport, TN, Feb. 24, 1998; Acute Oral Toxicity Study in the Rat, Eastman Chemical Company, 14 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 21 of 39 PageID 22595 support their arguments by claiming the 2006 EPA Question Answer Guidance requires reporting hematuria and (2) arguing testimony from Plaintiffs? expert Dr. King supports this.43 Oddly, Plaintiffs claim ?hematuria . . . clearly falls within the category of serious effects (ie. ?serious or prolonged incapacitation, including the loss of a normal bodily function, resulting in relatively serious impairment of normal activities?) observed in acute tests that EPA considers reportable without regard to exposure.?44 In fact, the provision they cite45 actually indicates the presumption46 that observations from acute tests (?such as LDSOs and range-?nding tests?) need not be reported.47 The reason EPA ?nds these observations not reportable is that acute tests are typically performed using elevated dose levels intended to cause adverse effects or even death. One type of routine acute test, the LDSO, is so~called because it determines the lethal dose at which 50% of the animals in the study die.48 Because the physical process of death can produce a variety of grotesque acute studies especially LDSOs are not reliable frameworks for determining if it is exposure to the test chemical that is causing the or death itself. Kingsport, TN, Dec. 1, 1999; and A Two?Week Dermal Toxicity Study in the Rat, TX-98-129, Eastman Chemical Company, Kingsport, TN, Jan. 6, 1999. 43 It should be noted that another Piaintiffs? expert, Richard Sussman, has previously indicated industry interpreted the 8(e) reporting requirements as not involving consideration of urinalysis data unless two other criteria were already met. Letter from Robert Sussman, Counsel for various chemical companies, Latham Watkins to Victor Kimm, Deputy Assistant Administrator, EPA, Encl. Flowchart at 25 (Dec. 26, 1991). Attached as Ex. G. 4? Plfs.? Mom. 13 (citing 2006 EPA Question Answer Guidance at Q23). ?5 How can reportable information under TSCA 8(e) be distinguished from routine tests, such as LD5OS and range??nding tests?? 2006 EPA Question Answer Guidance at Q23. 46 has been longstanding position that acute toxicity. studies that do not show serious toxicologic effects neurotoxicity) are of limited interest to EPA in a Section 8(e) context.? Kimm Ltr, Enci. at 56, supra n25. 47 Question 23 from the 2006 EPA Question Answer Guidance provides for a possible exception to the general ruie of not reporting incidental effects from acute studies for ?serious human health effects includ[ing] any pattern of effects or evidence that reasonably supports the conclusion that the chemical substance or mixture can produce cancer, mutation, birth defects or toxic effects resulting in death, or serious or prolonged incapacitation, including the loss of a normal bodily function resulting in relatively serious impairment of normal activities.? What was observed in the three studies Plaintiffs reference does not fall within that exception. 48 To put the studies at issue in context, it should be noted that two studies (the acute oral toxicity and acute dermal toxicity) were LDSOs, and one (the two?week dermal toxicity) involved repeat-dose testing for systemic toxicity via the dermal route. 15 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 22 of 39 PageID 22596 In the 1999 dermal toxicity rat study, the laboratory reported that single incidence of hematuria and discolored (green) urine was observed for one high-dose female on Day 2? under a heading entitled ?incidental clinical abnormalities.?49 That means hematuria was observed in only one rat on one day early in the two-week study, and never again. EPA has held transient effects need not be reported.50 Furthermore, the lab itself described the ?nding as ?incidental.? Indeed, Plaintiffs can point to no support in medical or toxicological literature for their contention that transient hematuria is normally related to ?serious or prolonged incapacitation, including the loss of a normal bodily function, resulting in relatively serious impairment of normal activities.?51 AlSo, the hematuria Plaintiffs point to in the 1998 Acute Dermal Toxicity Study in the Rat, 08, was the result of an acute study. In fact, ?red urine and N-Multistix52 positive results were seen at a dose level that was lethal to some rats.?53 There was also the separate conclusion that this study was rendered unreliable by the fact that rats used by the Kodak laboratory around this time in various studies, including the 1998 Acute Dermal Study,54 suffered from illnesses and health problems linked to their breeder (SASCO), and the Kodak laboratory shifted to receiving the same Sprague-Dawley rat strain from a different breeder.55 Indeed, after the SASCO rats were replaced, the lab ran a follow-up study,56 and only on female rats, since the hematuria in the initial study was only observed in female rats.57 A dose of 49 A Two-Week Dermal Toxicity Study in the Rat (TX-93429), Jan. 6, 1999 (?1999 Two-week Dermal Toxicity Study?). 50 See 1991 EPA 8(e) Reporting Guide at 34 (discussing effects ?found simply to be transient rather than either intermittent or continuous in nature?); Sussman Ltr, Encl. at 9 (Dec. 26, 1991), cited supra at 11.43. 51 Plfs.? Mem. 13. I 52 N?Multistix are dipsticks that test for the presence of blood in the urine. Their tendency for giving false positives led to their limited use in the Kodak laboratory. O?Donoghue Dep. 20: 1-22z25; 82:7-88220. 53 O?Donoghue Decl. 8. 54 1998 Acute Dermot Toxicity Study in the Rat, O?Donoghue Dep. 67:3. 55 O?Donoghue Dep. 87:2?4. 56 Acute Oral Toxicity Study in the Rat, Eastman Chemicai Company, Kingsport, TN, Dec. 1, 1999. 16 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 23 of 39 PageID 22597 500 mg/kg was used because this was the dose in the ?rst study at which hematuria was observed without test subject death or excessive toxicity.58 No hematuria, however, was observed.59 Eastman determined that MCHM did not cause hematuria, and revised its Safety Data Sheet to remove the risk of hematuria which Eastman added as a precaution after the TX- 97?308 results.60 Accordingly, the ?ndings from the two studies in which hematuria was visually observed do not reveal anything other than an incidental observation and an uncorroborated effect that did not pose ?a substantial risk of injury to healt e. Other ?health effects? are not a substantial risk under Plaintiffs repeatedly take unremarkable ?ndings and overstate the risks. Plaintiffs take out of context61 ?ndings relating to organ weight measurements to try to show a change, even when the study notes that the weight changes were not signi?cant.62 Similarly, even though organ weight change or blood chemistry ?uctuations are only reportable when both are observed, and at signi?cant levels, Plaintiffs suggest only one factor triggers reporting.63 Plaintiffs also falsely con?ate mutagenicity with toxicogenomics, even though the two involve different 57 O?Donoghue Dep. 87:13-14. 58 O?Donoghue Dep. 75:1-82:25. 59 Id. at 87:20?25. 60 61 Plfs.? Mem. 11. 62 Four?week Oral Toxicity Study of in the Rat April 3, 1990 (?1990 Oral Study of Pure (?None of the effects were indicative of more than minor toxicity and all were most likely reversible?); A Two-Week Dermal Toxicity Study in the Rat (TX-98-129), Jan. 6, 1999 (?1999 Twomweek Dermal Toxicity Study?) (noting ?the absence of signi?cant histopathologic and serum clinical chemistry changes?). 63 Compare Plfs.? Mem. 11 with Pifs.? Mem., Ex. 2 at 22. Interestingly, Plaintiffs? expert, Dr. Sussman, indicated the understanding among industry that EPA guidance does not require for reporting determinations to even consider ?any histological changes in an organ, clinical chemistry hematology, urinalysis, organ weights? unless the following two criteria were already met: (1) ?clear signs of neurotoxicity and/or treatment related to changes in gonadal weight, histopathology or function and/or biologically or statistically significant increase in tumor incidence at any dose level? and (2) NOEL greater than 5 mg/kg/day or a LOEL such that the NOEL is expected to be greater than 5 mg/kg/day. Sussman Ltr, Flowchart Encl. at 25, cited supra at 11.43. 17 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 24 of 39 PageID 22598 research.64 Lastly, Plaintiffs? interpretation of an ataxia observation as a basis for neurotoxicity reporting has been speci?cally questioned by EPA itself since ?the testing laboratory staff simply used the term ataxia to describe the animals? physical state as being something other than active.? Kimm Ltr, Encl. at 3, supra n.25. These observations do not require reporting. 2. MCHM aquatic toxicology studies do not demonstrate a substantial risk of injury to human health or the environment under Plaintiffs claim Eastman should have reported four MCHM aquatic toxicology studies,65 including three Eastman conducted years before the spill, and a highly publicized post?spill study conducted at the University of South Alabama on one test organism, D. magma. Plaintiffs? theory is based on the unsupported argument by their expert, Dr. Spadaro, that coal processors regularly discharge MCHM into water, and that environmental exposure post?spill constitutes widespread exposure suf?cient to require reporting of the study. Section 8(e) requires nothing of the sort. Plaintiffs put forth no evidence of a single routine MCHM commercial discharge by coal- processing companies, much less Eastman?s knowledge of a purported pattern of discharges by processors. Just as TSCA 8(0) does not hold chemical manufacturers accountable for recording incidents related to exposure as discussed in Part VI, 8(e) does not impose a duty? on manufacturers to. search for or report this information. The 2006 EPA Question Answer Guidance indicates that TSCA 8(e) ?is not intended to compel searches for information or extraordinary efforts to acquire information.? Id. at A3. This guidance takes on special force in situations where pollution, when it occurs, may be unknown even to 64 Curtis Klaassen, et ai., Casarett Doull?s Toxicology: The Basic Science of Poisons 41, 445 (8th ed. 2013). 65 These four studies are: Basic Toxicity of Crude Eastman Kodak Company, Rochester, NY, (Feb. 10, 1977); An Acute Aquatics Effects Test with the Fathead Minnow, Pimephales promelas, Eastman Kodak Company, Rochester, NY (1998); An Acute Aquatic Effects Test with the Daphnid, Daphnia magna, Eastman Kodak Company, Rochester, NY (1998); Rahui Gupta, et a1., Multi?disciplinary Approach to the development of Sound Scienti?c Support: The West Virginia Experience, National Association of County and City Health Officials (N ACCHO) Annual Conference (2014). 18 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 25 of 39 PageID 22599 the Operator, or worse, intentionally hidden. Plaintiffs do not present adequate factual or legal support for their theory that unknown, undocumented malfeasance by a third party makes a 8(e) violation out of Eastman?s reasonable decision not to report aquatic toxicology studies based on intended use exposure level. Similarly, Plaintiffs do not even allege any serious harm to aquatic organisms as a result of the Elk River spill, much less widespread harm, as is necessary for reporting to be required. As the 2006 EPA Question Answer Guidance at Q. 31 indicates, under Part V(b) of the 2003 EPA 8(e) Guidance, various factors are needed for nonhuman organism exposure to require reporting. Eastman?s aquatic toxicity studies do not satisfy any of those factors because MCHM is not ?known to cause serious adverse effects in nonhuman organisms,? nor is widespread exposure part of intended use, id. at pronounced bioaccumulation has not been observed in the Elk River area, id at Elk River species interrelationships have not been changed to a significant degree, if any degree at all, id. at MCHM is not a chemical that I rapidly degrades into an unacCeptably toxic substance, id. at and no large?scale ?sh kills or other environmental destruction due to MCHM has been documented in the spill?s aftermath, id. at (5). Plaintiffs? lack of evidence of widespread environmental damage and ?multiple releases to water at signi?cant levels during coal preparation operations,? Plfs.? Mem. 15, precludes summary judgment on Plaintiffs? 8(e) reporting claims for the aquatic toxicology studies. 3. PowerPoints and articles regarding five public health studies do not reasonably support a conclusion of substantial risk to human health under After their participation in the investigation and recovery efforts following the Freedom Industries spill, various involved individuals delivered a handful of presentations and articles. Though Plaintiffs note the potential reporting obligation for what the 1978 EPA 8(e) Policy 19 Case Document 821 Filed 06/03/16 Page 26 of 39 PageID 22600 Statement terms informal ?reports concerning and studies of undersigned [sic], uncontrolled circumstances,?66 Plaintiffs ignore other applicable criteria negating a reporting requirement here. First, Plaintiffs overlook that the very guidance they cite limits reporting to information that must ?reasonably support[]? a conclusion of ?substantial risk? and ?reliably ascribe the effect to the chemical.? Id. Plaintiffs also ignore a change to the reporting requirements after the 1978 Policy Statement creating a reporting exception for secondary source material.67 None of the articles and PowerPoints cited by Plaintiffs meet the reporting criteria. None include underlying data or enough detail to allow assessing if they support ?nding substantial risk of injury to human health or the environment as the 2003 EPA 8(e) Guidance contemplates. This data is of special concern in the context of secondary studies, so that the potential reporting party, Eastman, can ensure it is reporting credible results, and notpassing along inaccurate information that would hinder rather than help regulators? risk assessment. Furthermore, language in some of the studies suggests their unreliability. For instance, one report notes: ?[S]everal confounding factors existed? and is unlikely that all reported effects were directly related to MCHM toxicity.? Plfs.? Mem., Ex. 17 at 2.68 Such unsupported speculation about chemical effects does not meet the standard for ?reasonabl[e] support? for 66 43 Fed. Reg. 11112. 67 The 2003 EPA 8(e) Guidance, 68 Fed. Reg. 33133 provides: The rationale fort these proposed changes was to relieve persons who are potentially subject to reporting under 8(e) from the burden of considering information from secondary sources when the Secondary source does not provide suf?cient information for a person to judge whether the information should be reported. For instance, a manufacturer of alchemical might obtain a news article about research done by another company. A person reading the article would need the underlying study to evaluate the true signi?cance of the results of the research and, based on the evaluation, make a judgment as to whether there is a substantial risk of injury to human health or the environment. In such a case, the potential reporting obligation falls on the company that generated the research discussed in the news article. 68 Another states, ?These data cannot ?prove? that MCHM caused the reported Plfs. Mem., EX. 16 at 6. 2O Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 27 of 39 PageID 22601 substantial risk ?ndings set forth in In re Elementz's Chromium, 2015 EPA App. LEXIS 5 (EPA Mar. 13, 2015) and discussed in Part IVA. 4. Water monitoring and odor studies do not indicate a substantial risk under Plaintiffs claim obligates Eastman to report odor recognition tests and water monitoring conducted by governmental entities indicating widespread exposure to MCHM and detection of licorice odor. This is not so. Smelling a licorice scent is not an adverse effect on human health, and indeed, Plaintiffs do not even attempt to point to any authority for this position. Furthermore, the language Plaintiffs cite from the 2003 EPA Guidance as triggering reporting due to widespread exposure omits a key quali?er: the reporting obligation is triggered only by ?Non?emergency situations involving environmental contamination.? 68 Fed. Reg. 33138. Plaintiffs do not dispute that the Elk River spill was an emergency environmental contamination. Plfs.? Mem?. 5-6. Using language taken out of context as the only support for Plaintiffs? argument that water monitoring and odor detection studies require reporting speaks to the weakness of their claim. Because Plaintiffs fail to put forth a suf?cient legal and factual basis for required reporting for water monitoring and odor recognition results, summary judgment would be inappropriate. B. Exemptions from the reporting requirement of 8(e) 1. The 22 studies are exempt because of EPA awareness of the studies. All of the 22 studies are exempt under 8(e) from the reporting requirement which contains an exception from reporting for information of which the EPA Administrator is already ?adequately informed.? The 2003 EPA 8(e) Guidance includes several exemptions for circumstances presented by measures taken in the aftermath of the 2014 Elk River spill. First, . ?To the extent EPA Headquarters and the Regions become involved in joint cleanups, 21 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 28 of 39 PageID 22602 assessment, etc., or act in advisory roles with other Federal agencies, the Administrator could reasonably be considered to be adequately informed.? EPA Section 8(e) Guidance, 68 Fed. Reg. 33134. The very next day after Freedom Industries detected their plant?s contamination of the Elk River, EPA Headquarters and Region 3 were involved in on-the?ground risk assessment.69 EPA was also acting in an advisory role and coordinating with other federal agencies, id, in particular FEMA, CDC, NTP, and NIH. Dennis Matlock, Charleston WV Chemical Leak, Environmental Protection Agency OSCs maintained EPA personnel assigned 24~7 friday [sic] 1/ 10/14 through saturday [sic] 1/1 1/ 14 as (liasons [sic] to FEMA) to the FEMA Regional Office (FEMA Region 3) informed of the work on the In addition, EPA has had access to all of the 22 studies at issue here, which are each available on the internet.71 Accordingly, Plaintiffs? argument that the various studies cited in Plaintiffs? Motion should have been reported under 8(e) after the spill are foreclosed on several independent grounds, a point even Plaintiffs appear to concede by admitting availability of these studies and reports extended ?perhaps to EPA regional technical staf Plfs.? Mem. 24. Also, the 2003 EPA 8(e) Guidance exempts studies involving adverse effects from reporting if they are listed in ?[d]atabases available to the public (online or in paper versions), such as the National Library of Medicine (NLM) databases (Toxline, Medline, Hazardous Substances Data 69 Larry Cseh, Contaminated Water Incident: Charleston, WV, Environmental Health Of?cer Safety Advisory Committee, (discussing role in reviewing Eastman studies to develop response and indicating National Response Plan was in effect from Jan. 10?20, 2014), . ehopac. org/index.php/resp onsenarratives Charleston?WV, EX. Centers for Disease Control and Prevention, Information about MCH1VI (Feb. 5, 2014) Centers for Disease Control and Prevention, Summary Report of Short?term Screening Level Calculation and Analysis of Available Animal Studies for MCHM (J an. 20, 2014) (same), Ex. I. 70 Dennis Matlock, Charleston WV Chemical Leak, EPA (2016) Ex. I. 71 For example, Eastman had the MCHM studies the company conducted posted online shortly after the spill and shared the study information with authorities in order to aid in the response effort. Tom Conuel, Rapid Response: West Virginia 2014 Elk River Spill, NLM in Focus (Mar. 9, 2016), Green Dep. 32. 22 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 29 of 39 PageID 22603 Bank, etc.) . . . 3?72 MCHM studies are listed in Toxline, and the listing includes the very studies, data and other information both from Eastman and the NTP which Plaintiffs? Motion for Summary Judgment alleges that Eastman should have reported to EPA.73 Plaintiffs? request for an injunction ordering Eastman to report studies is therefore moot. Plaintiffs ignore multiple reporting exemptions which preclude Plaintiffs? 8(e) claims altogether under the overarching policy that EPA does not need information it can be presumed to have or to get from other sources. 2. NTP studies are exempt from reporting under . There are multiple reasons Why the NTP studies are exempt from reporting. As discussed in Part IV.B.1, studies involving adverse effects?. are exempt from reportng if listed in public databases, such as Toxline?s listing of the three NTP studies Plaintiffs cite. Also, the 1991 EPA 8(e) Reporting Guide indicates that ?with regard to a public scienti?c conference/meeting, visually or verbally obtained information from such meeting is subject to Section 8(e) reporting unless the obtained information is captured accurately/ adequately in a meeting transcript, abstract, or other such written record or document that is to be formally released to the public within a reasonable time frame.? Id. at 7 (emphasis in original). Under this guidance, the NTP research was not required to be reported because the research was publicly released in just such a forum: in a presentation at the NTP Board of Scienti?c Counselors Meeting on June 16, 2015 entitled, Response to the Elk River Chemical Spill.? The NTP study results at issue here 7? 68 Fed. Reg. 33132, 33139. - 73 Toxnet Toxicology Data Network 4?Methyieyclohexanemethanol, National Library of Medicine (Sept. 4, 2014), The database listing for MCHM is attached as EX. K. I 74 On summary judgment, inferences regarding adverse effects are drawn in favor of the non?moving party, Eastman. 23 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 30 of 39 PageID 22604 were discussed in a presentation webcast and transcript available to the public and EPA on the NTP website.75 Furthermore, as Plaintiffs concede, the 2003 EPA 8(e) Guidance provides that reporting is not required for of?cial publication or of?cial report (draft or ?nal) published or made available to the public by another Federal Agency and any information developed by another Federal Agency as a result of a toxicological testing/study program, or site evaluation, in which EPA is collaborating on the design, review or evaluation of testing/sampling plans or resultant data.? (emphasis added). To explain away the inconvenient fact that NTP is a federal agency that has developed these reports as a result of toxicological testing, and collaborated with EPA in Elk River spill response and site evaluation,76 Plaintiffs claim has not issued official reports on any of the studies but instead has merely made available informally an initial summary of results.? Plfs.? Mem. 17-18. Of course, Plaintiffs? semantic antics aside, the reporting exception speci?cally'extends to reports regardless of whether ?draft or ?nal.? Finally, there is insuf?cient evidence for the argument advanced by Plaintiffs? expert Robert Sussman that ?it is unwarranted for companies to assume that EPA senior managers had access .to or were informed about the NTP ?ndings. . . Plfs.? Mem. 18 (citing Sussman Rebuttal Decl. ii 43). This assertion belies the reality of the close relationship between NTP and EPA, both in the context of the spill response and in general. The EPA, for example, holds a seat on the NTP Executive Committee,77 and the two entities both rely on information present in the 75 Scott Auerbach, Webcast of NTP Response to the Elk River Chemical Spill, National Toxicology Program (June 16, 2015), Ex. L. West Virginia Chemical Spill, National Toxicology Program, West Virginia Chemical Spill: NTP Studies and Results, NTP (Dec. 9, 2015), 76 EPA has been collaborating with many federal agencies, including NIEHS, since shortly after the spill to evaluate toxicological effects. Tom' Conuei, Rapid Response: West Virginia 2014 Elk River Spill, NLM in Focus (Mar. 9, 2016), EX. M. 77 Organization, National Toxicoiogy Program (Dec. 9, 2014), 24 Document 821 Filed 06/03/16 Page 31 of 39 PageID 22605 Toxline database maintained by the same agency that houses NTP. Accordingly, Plaintiffs? claim that Eastman must report NTP studies lacks suf?cient factual support for summary judgment. 3. Public health studies are exempt from reporting under Plaintiffs neglect other reasons that the public health studies are exempt from reporting. Plaintiffs cannot dispute that these studies have been covered by numerous sources in the media,78 a fact which defeats their reporting requirement argument. 2003 EPA 8(e) Guidance (?substantial risk? information need not be reported if obtained from a ?news publication newspaper, news magazine, trade press) with circulation in the United States,? at Part or a ?radio or television news report broadcast in the United States,? at Part Furthermore, all of the public health publications Plaintiffs claim should have been reported were presentations made available to the public and EPA in the formats Plaintiffs include in their exhibits, and therefore do not require reporting. 2003 EPA 8(e) Guidance, Part Lastly, none of the studies document health effects of the severity rising to the level of ?substantial risk of injury to human healt See Part. IVA Supra. For all of the above reasons, Plaintiffs lack undisputed evidence for summary judgment on their public health study claims under V. Plaintiffs Lack An Actionable Claim Under ?5 For Purported Deficiencies In Eastman?s 1997 Premanufacture Notice. Plaintiffs next take issue with Eastman?s October 20,1997 Premanufacture Notice for a secondary component of crude MCHM, cyclohexanemethanol 4? - (methoxymethyl) a submission that was required under 15 U.S.C. 2604 when 78 E. 3, Jeff Jenkins, New study results Show ?long?term heaith effects? not expected from MCHM spill water emergency (Jun. 16, 2015), . 25 Case 2:14-Cv-01374 Document 821 Filed 06/03/16 Page 32 of 39 PageID 22606 crude MCHM became a commercial product.79 Plaintiffs concede ?the EPA did not identify any issues before the 90-day review period expired on January 21, 1998,? Plfs.? Mom. 25, but nevertheless now assert that they can base a claim on What they say are defects in the PMN. This argument fails for several reasons. First, as a matter of law, any alleged violation of 5 in connection With the 1997 ?ling is time-barred by the applicable ?ve-year statute of limitations. 3M Co. v. Browne)?, 17 F.3d 1453, 1455-56 (DC. Cir. 1994) (applying statute of limitations in 28 U.S.C. 2462 in holding that actions for violations of PMN requirements must be commenced Within five years of the date of the violation).80 The five?year statute of limitations applies to citizen suits. Catellus Dev. Corp. v. LD. McFarland 910 F. Supp. 1509, 1518 (D. Or. 1995) (citing Bodne v. Geo A. Rheman Co, Inc, 811 F. Supp. 218, 221 (D.S.C. 1993) ?for the proposition that ?28 U.S.C. 2462 is the relevant federal statute of limitations to citizen actions under environmental Second, Plaintiffs cannot demonstrate that the injunctive relief they seek would redress any harm they are currently suffering, despite their demand that this Court ?[r]equire Eastman to Withdraw its 1997 PMN and resubmit it with all available data on crude and pure MCHM and a full and complete description of exposure and release at user sites.? Plf?s Mem. 29. This ?ies in the face of EPA procedure. TSCA does not require that a base set of test data accompany a as a result many PMNS are ?led iwith little or no accompanying toxicology or exposure data. What is essential to any PMN is the chemical identity of the substance proposed for commercial manufacture. EPA uses that identity information to conservatively predict toxicity 79 When Eastman sought to commercialize crude MCHM in the 19903, a PMN was required for 8? See also Arch Mineral Corp. v. Babbitt, 104 F.3d 660,- 669?670 (4th Cir. 1997) (adopting the reasoning of 3M applying statute of limitations to administrative proceedings). 81 See also Nat?l Parks Conservation Ass?n, Inc. v. Term. Valley Auth, 502 F.3d 1316, 1327?28 (11th Cir. 2007) 26 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 33 of 39 PageID 22607 based on structure activity relationships (SAR) to other chemicals with related structures.82 If the modeling predicts toxicity that could pose an unreasonable risk, additional data is often generated to eliminate conservatism introduced by the SAR model. By allowing the PMN review period to expire without imposing regulatory controls, EPA effectively determined that it had enough information to conclude allowing on the Inventory would not likely pose an unreasonable risk. Furthermore, withdrawing and resubmitting the PMN to EPA would do nothing for Plaintiffs. Withdrawing a PMN does not remove a chemical from the TSCA inventory of chemicals that can be produced that horse left the stable in 1998, when the EPA elected not to block manufacture of the chemical, the review period expired, the notice of commencement issued, and the chemical was added to the inventory, giving any company the right to manufacture it.83 If a new PMN were ?led, the EPA would likely reject it because the chemical is already on the inventory; thus, there is no real way to accomplish the inj unctive relief the Plaintiffs seek. Plaintiffs concede that 5 only requires a manufacturer to provide information that is ?known? to or ?reasonably ascertainable by? the PMN submitter. Plfs.? Mom. 28. Plaintiffs claim, ?Eastman had every reason to know that signi?cant releases and discharges to water are routine at coal preparation sites.? Id. There is absolutely no evidence in the record, however, indicating that Eastman had any actual knowledge at the time it submitted the PMN in 1997 of these releases, that they are real, or that they were readily ascertainable. Plaintiffs? theory 82 Chem. Categories Used to Review New Chem. under TSCA, EPA (Sept. 29, 2015) 83 Plaintiffs? only means to remove a chemical already on the inventory would be to initiate legal action against EPA under TSCA 6, 15 U.S.C. 2605, which Plaintiffs have declined to do. EPA would then have to seek to ban the chemical or restrict its use under Section 6 or obtain a consent decree. EPA could also pursue a Signi?cant New Use Rule or issue a test ruie if they were, in fact, concerned about the chemical?s prevalence in 27 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 34 of 39 PageID 22608 directly con?icts with EPA guidance noting the limitations a PMN Submitter has regarding information on sites it does not control.84 Plaintiffs cite no EPA guidance or rulings for their theory of PMN reporting requirements, nor justify their allegation that continuous, widespread MCHM discharges occur at coal processing plants with anything other than the uncorroborated say-so of their expert, Jack Spadaro. Plfs.? Mem. 28, n.68. Plaintiffs? PMN claim does not merit summary judgment. VI. Plaintiffs Lack An Actionable Claim Regarding . Plaintiffs complain that Eastman violated TSCA 15 U.S.C. 2607, which requires companies to keep records on allegations of harmful effects caused by chemicals, thus enabling the company or EPA to learn of patterns of allegations that may point to a previously unknown adverse effect caused by a chemical or group of chemicals. The statute states: Any person who manufactures, processes, or distributes in commerce any chemical substance or mixture shall maintain records of signi?cant adverse reactions to health or' the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture. . . . Records required to be maintained under this subsection shall include records of consumer I allegations of personal injury or harm to health, reports of occupational disease or injury, and reports or complaints of injury to the environment submitted to the manufacturer, processor, or distributor in commerce fromany source. 15 U.S.C. 2607(c). TSCA 8(c) final rule, 40 C.F.R. 717, attached as EX. N, became effective on November 21, 1983. As noted above, Plaintiffs may not make a citizen suit claim here because it was not included in their notice letter. Furthermore, EPA guidance makes clear that these claims would be unfounded even if they were a permissible part of this case. 84 EnVironmental Protection Agency, EPA Instructional Manual or Reporting Under TSCA ?5 New Chemicals Program, 2015, at 48, _manual_2015_5~ 26?2015.pdf: ?In most cases, you have more speci?c information on sites you control than sites you do not control. If you do not have specific information on sites controlled by others, describe a typical operation involving the particular processing or end use application based on information available to you . . . 28 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 35 of 39 PageID 22609 In pertinent part, 40 C.F.R. 717.10 provides that allegations state the cause of the effect and that companies may opt for allegations to be by signed written submission, promoting integrity in allegations and facilitating tracking-patterns among reported effects. I Subsequently, the EPA published Question Answer Guidance in 1984.85 Both the rule and guidance make clear that companies are not obligated to record allegations of chemical effects unless (1) the allegation is signed, 40 C.F.R. (2) the allegation is submitted to the company, id, and (3) the allegation includes information regarding the cause and nature of a suf?ciently severe adverse reaction. 40 C.F.R. Plaintiffs do not allege any of the materials86 they contend Eastman should have recorded contain even a single signed report from. an individual exposed to MCHM, any instance of an affected person submitting a report or authorizing someone to do so on their behalf, or specific allegations adequately describing cause and nature of the effect. 1 In particular, the plain language of the statute itself, in addition to the rule and guidance, require that the report regardless of its source be ?submitted to? the company. 15 U.S.C. 2607(0). This is not a mere knowledge standard, but requires actual transmission of the report to the manufacturer. See Pttr?pac Pharm. Co. v. Thompson, 354 F.3d 877, 889 (DC. Cir. 2004) (interpreting verb ?submitted? for mailing requirement; submission involved an actual transmission). Plaintiffs concede that ?consumers communicated their to health authorities and researchers and not to Eastman directly.? Plfs.? Mom. 29. Plaintiffs therefore cannot demonstrate a qualifying allegation submitted to Eastman on the basis of these reports. 85 EPA reiterated in its 8(c) brochure that ?[c]ompanies subject to the rule are not?required to record unsigned written allegations.? Of?ce of Toxic Substances, Environmental Protection Agency, Answers to Your Questions About the TSCA Section 8(0) Ruie (1984), attached as EX. 0. See also Of?ce of Toxic Substances, Environmental Protection Agency, Questions and Answers Concerning the TSCA Section 8(c) Rule Questions Received at: Seminar on Toxic Substances Control Act Section 8(0) Recordkeeping and Reporting Allegations of Adverse Reactions November 10, 1983 (1984) at 3 (same), attached as Ex. P. 86 These reports and presentations are cited in Plfs.? Mem, Ex. 29 at 2?3. 29 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 36 of 39 PageID 22610 Plaintiffs? argument that a recordkeeping obligation was triggered ?once Eastman came into possession of analyses and reports tabulating and describing these id, is out of step With the rule and guidance. EPA maintains for good reason that although a consumer report can be made for a consumer by another person, the report must include a report speci?c to an individual, and be signed by someone. Tabulations and analyses anonymously aggregating individual reports do not meet these requirements. The ?presentations and reports,?87 Plaintiffs claim Eastman should have submitted comprise an ?analy[sis] [of] . . . records,? a ?compilation,? a ?survey? and ?analysis,? a ?catalog[]? and and ?population survey,? respectively.88 None involve personal reports, and therefore do not qualify for recordkeeping requirement. For instance, reports fail to describe on a personal level89 the nature of the alleged exposure and reaction to or any speci?c reactions in the studies that rise to the level of signi?cant adverse reactions.91 Accordingly, Plaintiffs fail to demonstrate evidence cf unrecorded qualifying allegations necessary to succeed on their 8(0) claim for summary judgment. *7 Plfs.? Mem. 29. 88 Id. at 19?20. 89 EPA guidance states: ?Isolated medical data are not inherently allegations. If a doctor were to make an allegation (Le, a statement or assertion) on behalf of a patient, such data could be cited as the signi?cant adverse reaction.? Ex. at 4. Plaintiffs, however, present no evidence of any doctor who submitted to Eastman a report for a patient of allegedly adverse reactions linked to MCHM. 9? The ailegation must make a link between a particular company?s ?product, process or ef?uent and the human health or environmental effect. . . . The nature of the adverse reaction should be explained. . . . [T]he industry is only required to record ?signi?cant adverse reactions.? Of?ce of Toxic Substances, Environmental Protection Agency, Answers to Your Questions About the TSCA Section 8(0) Rule (1984), Ex. 0. 91 See (?signi?cant adverse reactions to human health include: . . cancer or birth defects . . . . blood, reproductive, or neurological disorders?). Plaintiffs claim, ?[b]ecause the reported involved ?partial or complete impairment of bodily functions? and ?impairment of normal activities?, they qualify as ?significant adverse reactions? under the EPA 8(c) regulations.? Id. at 29. Plaintiffs have cherry-picked from the description of what quali?es as significant adverse reactions, without failing to note that the form of impairments they describe should be ?experienced by ali or most of the persons exposed at one time? or ?experienced each time an individual is exposed.? 30 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 37 of 39 PageID 22611 CONCLUSION Plaintiffs have failed to provide suf?cient legal and factual support for their claims that Eastman violated TSCA and 5, claims which the limits of both TSCA and the Constitution deny them standing to press. WHEREFORE, based on the foregoing, Defendant, Eastman Chemical Company requests the Court deny Plaintiffs: Motion for Summary Judgment. ATTORNEYS FOR DEFENDANT EASTMAN CHEMICAL COMPANY E. Williams Marc E. Williams (WV Bar No. 4062) Robert Massie (WV Bar No. 5743) Melissa Foster Bird (WV Bar No. 6588) NELSON MULLINS RILEY SCARBOROUGH LLP 949 Third Ave, Suite 200 Huntington, WV 25701 Phone: (304) 526?3 501 Fax: (304) 526-3541 Email: Email: bob.massie@nelsonmullins.com Email: Robert Scott (Admitted pro hac vice) Marquel S. Jordan (Admitted pro hac vice) BLANK ROME LLP 717 Texas Avenue, Suite 1400 Houston, Texas 77002 Phone: (713) 228-6601 Fax: (713) 228-6605 Fax Email: Email: 31 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 38 of 39 PageID 22612 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON GOOD, et. al., Plaintiffs, AMERICAN WATER WORKS COMPANY, et. (11., Defendants. CIVIL ACTION NO.: (Consolidated with Case No. 2:14-11011; Case No. 2114?13164; Case No. 2:14? 13454) HON. JOHN T. COPENHAVER CERTIFICATE OF SERVICE This under-signed attorney hereby certifies that a copy of the foregoing "Defendant Eastman Chemical Company?s Motion for Summary Judgment on the Issue of Corrosion has been served on the 3rd day of June, 2016. This Certificate of Service is being provided to the Court and counsel through the ECF system. David R. Barney, Jr., Esq. Kevin Thompson, Esq. Barney Thompson PLLC 2030 Kanawha Boulevard East Charleston, WV 25311 Phone: 304.343 .4401 Facsimile: 304.343.4405 Email: drbarneywv@gmail.com Email: kwthompsonwv@gmail.com Counsel for Plaintiffs 32 Case 2:14-cv-01374 Document 821 Filed 06/03/16 Page 39 of 39 PageID 22613 Van Bunch, Esq. Bonnett, Fairbourn, Friedman Balint, RC. 2325 E. Camelback Road, Suite, 300 Phoenix, Arizona 85016 Phone: 602.274. 1100 Facsimile: 602.274.1199 . Email: Vbunch@bfib.com Counsel for Stuart Calwell, Esq. Alexander D. McLaughlin, Esq. The Calwell Practice, LC Law and Arts Center West 500 Randolph Street Charleston, West Virginia 25302 Phone: 304.343.4323 Facsimile: 304.344.3684 Email: scalwell@calwell.com Email: . com Counsel for Plaintiffs Thomas J. Hurney, Esq. Jackson Kelly, PLLC 500 Lee Street East, Suite 1600 PO. Box 553 Charleston, West Virginia 25301 Phone: 304.340.1000 Facsimile: Email: acksonkelly . com Counsel for Defendants Kent Mayo, Esq. Baker Botts LLP 1299 Ave, NW Washington, DC. 20004?2400 Phone: 202.639.1122 Facsimile: 202.585.1007 Email: kent.mayo@bakerbotts.com Counsel for Defendants Marc E. Williams 33