<ÿ*,*5)ÿ0@A44A,14ÿ,Bÿ*+0ÿ4ADÿC7A19AC5)ÿ5A7ÿC,))-*51*4ÿ+5H0ÿ67,CC06ÿ:Eÿbc C07901*ÿ516ÿ,3,10ÿ)0H0)4ÿ+5H0ÿ609)A106ÿ:EÿccÿC07901*Fÿd04CA*0ÿ*+0ÿ9,1*A1-06 A@C7,H0@01*ÿ,Bÿ5A7ÿO-5)A*E<ÿ9,4*4ÿ544,9A5*06ÿ2A*+ÿ9,@C)A5190ÿ,Bÿ*+0ÿ,3,10 e((f_ÿ+5H0ÿ4A.1ABA951*)EÿA19705406F g056ÿ*+0ÿ)0**07ÿ401*ÿ*,ÿ.,H071,74Iÿ+**C4Ihh222F0C5F.,Hh,3,10i 604A.15*A,14h56@A1A4*75*,7i0D*0164i6056)A10i5705i604A.15*A,14i=>;?i,3,10i 4*5165764 jA4A*ÿ,3,10ÿ604A.15*A,14ÿC5.0Iÿÿ+**C4Ihh222F0C5F.,Hh,3,10i604A.15*A,14 g;>k lmnoÿqrsmotsÿuvÿwqvtÿxyÿz{ x " # $22 # %2 2 # & & &4103& & ' & & 424 USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 1 of 47 ORAL ARGUMENT NOT YET SCHEDULED IN THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT No. 17-1172 AMERICAN LUNG ASSOCIATION, et al., Petitioner, v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, et al., Respondents. Petition for Review of Final Administrative Actions of the United States Environmental Protection Agency MOTION FOR SUMMARY VACATUR OR, IN THE ALTERNATIVE, FOR STAY PENDING JUDICIAL REVIEW Seth L. Johnson Laura Dumais David S. Baron Earthjustice 1625 Massachusetts Ave., N.W. Counsel for Clean Air Council and Ohio Suite 702 Washington, D.C. 20036-2212 Environmental Council (202) 667-4500 sjohnson@earthjustice.org ldumais@earthjustice.org dbaron@earthjustice.org Ann Brewster Weeks Clean Air Task Force 18 Tremont St., Ste. 530 Boston, MA 02108 (additional counsel listed inside) DATED: (Page 1 of Total) July 12, 2017 Counsel for American Lung Association, American Public Health Association, American Thoracic Society, Environmental Defense Fund, National Parks Conservation Association, Natural Resources Defense Council, Physicians for Social Responsibility, Sierra Club, and West Harlem Environmental Action USCA Case #17-1172 Document #1683752 Scott Strand Environmental Law and Policy Center 15 South Fifth St., Suite 500 Minneapolis, MN 55402 (612) 386-6409 sstrand@elpc.org Counsel for Environmental Law and Policy Center Filed: 07/12/2017 Page 2 of 47 Sean H. Donahue Susannah L. Weaver Donahue & Goldberg, LLP 1111 14th Street, NW, Ste. 510A Washington, DC 20005 (202) 569-3818 sean@donahuegoldberg.com susannah@donahuegoldberg.com Peter Zalzal Graham McCahan Rachel Fullmer Environmental Defense Fund 2060 Broadway, Suite 300 Boulder, CO 80302 (303) 447-7214 pzalzal@edf.org gmccahan@edf.org rfullmer@edf.org Counsel for Environmental Defense Fund (Page 2 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 3 of 47 TABLE OF CONTENTS INTRODUCTION AND SUMMARY OF ARGUMENT ........................................1 BACKGROUND .......................................................................................................3 I. OZONE SERIOUSLY HARMS HUMAN HEALTH. ..............................3 II. THE CLEAN AIR ACT PRESCRIBES A CAREFULLY-DESIGNED PROGRAM FOR CONTROLLING OZONE POLLUTION. ...................4 III. EPA FINDS THE 2008 STANDARDS INADEQUATE AND PROMULGATES STRONGER STANDARDS. ......................................7 IV. EPA ABRUPTLY DELAYS IMPLEMENTING THE NEW STANDARDS. .........................................................................................11 ARGUMENT ...........................................................................................................12 I. II. THE DESIGNATIONS DELAY IS UNLAWFUL AND ARBITRARY AND SHOULD BE SUMMARILY VACATED. ...................................12 A. EPA Has Not Satisfied the Statutory Requirements for Delaying Designations. ..................................................................................13 B. EPA’s Purported Justifications for the Delay Are Arbitrary and Unlawful. ........................................................................................17 C. Even If Some Delay Could Be Justified for Some Areas, EPA Has Not Justified the Across-the-Board One-Year Delay It Granted Itself. ...............................................................................................22 IN THE ALTERNATIVE, THE COURT SHOULD STAY THE DESIGNATIONS DELAY. .....................................................................24 A. The Designations Delay Will Irreparably Harm Petitioners. .........25 B. A Stay Will Not Harm Other Parties. ............................................31 C. The Public Interest Strongly Favors Staying the Designations Delay. .............................................................................................32 CONCLUSION ........................................................................................................35 i (Page 3 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 4 of 47 TABLE OF AUTHORITIES CASES PAGE(S) Alabama Power Co. v. Costle, 636 F.2d 323 (D.C. Cir. 1980) .............................................................................. 4 Am. Petroleum Inst. v. Costle, 665 F.2d 1176 (D.C. Cir. 1981) ............................................................................ 4 Am. Trucking Ass’ns v. EPA, 283 F.3d 355 (D.C. Cir. 2002) .......................................................................... 3, 4 American Lung Ass’n v. EPA, 134 F.3d 388 (D.C. Cir. 1998) ...................................................................... 17, 22 Amoco Production Co. v. Village of Gambell, 480 U.S. 531 (1987) ............................................................................................ 31 Chamber of Commerce v. SEC, 412 F.3d 133 (D.C. Cir. 2011) ............................................................................ 16 Clean Air Council v. EPA, No. 17-1145 (D.C. Cir. July 3, 2017) ................................................................. 13 Chlorine Chemistry Council v. EPA, 206 F.3d 1286 (D.C. Cir. 2000) .......................................................................... 21 Coleman v. Paccar, Inc., 424 U.S. 1301 (1976) (Rehnquist, J., in chambers) ............................................ 30 Del. Dep’t of Nat. Res. v. EPA, 785 F.3d 1 (D.C. Cir. 2015) ................................................................................ 24 In re Harman Int’l Indus. Sec. Litigation, 791 F.3d 90 (D.C. Cir. 2015) .............................................................................. 16 League of Women Voters v. Newby, 838 F.3d 1 (D.C. Cir. 2016) ........................................................24, 26, 30, 31, 34 Massachusetts v. EPA, 549 U.S. 497 (2007) ......................................................................................14, 17 ii (Page 4 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 5 of 47 Miss. Comm’n on Envtl. Quality v. EPA, 790 F.3d 138 (D.C. Cir. 2015) ..................................................5, 9, 10, 14, 20, 21 Moncrieffe v. Holder, 133 S. Ct. 1678 (2013) ........................................................................................ 16 Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins., 463 U.S. 29 (1983) ........................................................................................15, 24 Nat’l Ass’n of Farmworkers Orgs. v. Marshall, 628 F.2d 604 (D.C. Cir. 1980) ............................................................................ 31 Nat’l Lime Ass’n v. EPA, 233 F.3d 625 (D.C. Cir. 2000) ............................................................................ 20 NRDC v. EPA, 777 F.3d 456 (D.C. Cir. 2014) ........................................................................6, 17 Public Citizen v. Fed. Motor Carrier Safety Admin., 374 F.3d 1209 (D.C. Cir. 2004) .......................................................................... 22 Sorenson Comms. v. FCC, 755 F.3d 702 (D.C. Cir. 2014) ...................................................................... 20, 23 South Coast Air Quality Mgmt. Dist. v. EPA, 472 F.3d 882 (D.C. Cir. 2006) .............................................................................. 6 South Coast Air Quality Mgmt. Dist. v. EPA, 489 F.3d 1245 (D.C. Cir. 2007) ......................................................................6, 15 Union Elec. v. EPA, 427 U.S. 246 (1976) ............................................................................................ 34 United States v. Mead Corp., 533 U.S. 218 (2001) ............................................................................................ 17 Whitman v. Am. Trucking Ass’ns, 531 U.S. 457 (2001) ..................................................................................4, 15, 32 Wisc. Gas Co. v. FERC, 758 F.2d 669 (D.C. Cir. 1985) ............................................................................ 30 iii (Page 5 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 6 of 47 STATUTES 5 U.S.C. § 706(2)(A) ................................................................................................ 12 42 U.S.C. § 7407(d)(1)(A) ..................................................................................... 5, 8 42 U.S.C. § 7407(d)(1)(A)(i) .........................................................................5, 13, 14 42 U.S.C. § 7407(d)(1)(A)(ii) ............................................................................13, 14 42 U.S.C. § 7407(d)(1)(A)(iii) .............................................................................5, 14 42 U.S.C. § 7407(d)(1)(B) ......................................................................................... 5 42 U.S.C. § 7407(d)(1)(B)(i)............................................... 2, 5, 8, 12, 13, 16, 21, 22 42 U.S.C. § 7407(d)(1)(B)(ii) .................................................................................... 8 42 U.S.C. § 7408(a) ................................................................................................... 4 42 U.S.C. § 7409(a) ................................................................................................... 4 42 U.S.C. § 7409(b) ................................................................................................... 4 42 U.S.C. § 7409(d)(1) ...................................................................................4, 15, 33 42 U.S.C. § 7410(a).................................................................................................... 5 42 U.S.C. § 7410(a)(2)(I) ........................................................................................... 5 42 U.S.C. § 7410(c) ................................................................................................... 5 42 U.S.C. § 7471 ........................................................................................................ 5 42 U.S.C. § 7502 ........................................................................................................ 5 42 U.S.C. § 7502(b) ................................................................................................... 6 42 U.S.C. § 7502(c) ................................................................................................... 6 42 U.S.C. § 7503 ........................................................................................................ 6 42 U.S.C. § 7509a(a)................................................................................................ 18 42 U.S.C. § 7509a(b)................................................................................................ 18 iv (Page 6 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 7 of 47 42 U.S.C. § 7511 ........................................................................................................ 5 42 U.S.C. § 7511(a)(1) ............................................................................................... 6 42 U.S.C. § 7511a ...................................................................................................... 5 42 U.S.C. § 7511a(a)(2)(C)........................................................................................ 6 42 U.S.C. § 7511a(b)(2) ............................................................................................. 6 42 U.S.C. § 7511a(c)(2)(A) ....................................................................................... 6 42 U.S.C. § 7511b ...................................................................................................... 5 42 U.S.C. § 7511c ...................................................................................................... 5 42 U.S.C. § 7511d ...................................................................................................... 5 42 U.S.C. § 7511e ...................................................................................................... 5 42 U.S.C. § 7511f....................................................................................................... 5 42 U.S.C. § 7601(d)(1) ............................................................................................... 5 42 U.S.C. § 7602(d) ................................................................................................... 5 42 U.S.C. § 7619(b) ................................................................................................. 15 REGULATIONS 40 C.F.R. § 58.15 ...............................................................................................10, 20 FEDERAL REGISTER NOTICES 73 FR 16,436 (2008) ............................................................................................7, 33 75 FR 71,033 (2010) ................................................................................................ 24 77 FR 30,088 (2012) ................................................................................................ 20 80 FR 2206 (Jan. 15, 2015) ...................................................................................... 24 v (Page 7 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 8 of 47 80 FR 65,292 (Oct. 26, 2015) ......................................................3, 4, 7, 8, 14, 23, 30 81 FR 81,276 (Nov. 17, 2016) ................................................................................... 9 81 FR 91,894 (Dec. 19, 2016).................................................................................... 9 82 FR 29,246 (June 28, 2017) ................................... 1, 11, 14, 15, 16, 17, 18, 19, 22 vi (Page 8 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 9 of 47 GLOSSARY OF ACRONYMS AND ABBREVIATIONS The following is a glossary of acronyms and abbreviations used in this motion: NAAQS National ambient air quality standards ppb Parts per billion vii (Page 9 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 10 of 47 INTRODUCTION AND SUMMARY OF ARGUMENT Petitioners challenge the Environmental Protection Agency’s illegal and arbitrary delay of action mandated by the Clean Air Act to protect people from ground-level ozone, a dangerous and widespread air pollutant. EPA itself has found that ozone causes deaths, hospitalizations, asthma attacks, emergency room visits, and other serious harms, and that the existing federal limit on its concentration in the outdoor air is inadequate to protect public health. Yet, in a preemptory action involving no public participation and only cursory explication, EPA recently extended its deadline for promulgating initial area air quality designations for the 2015 national ambient air quality standards (“standards” or “NAAQS”) for ozone. 82 FR 29,246 (June 28, 2017), Ex.1; e.g., Letter from Scott Pruitt, Adm’r, EPA, to Doug Ducey, Gov. of Ariz., at 1, Ex.2 (“Delay Letter”).1 Under the Act, such designations are the essential step that triggers statutory obligations to implement measures to protect public health and welfare. The Designations Delay defers urgently needed cleanup of harmful ozone pollution that threatens people across the nation. EPA has estimated that compliance with the standards will—each year—save hundreds of lives, prevent 1 As explained below, the June 28 Notice followed letters sent June 6, with both announcing EPA was extending the deadline for promulgating initial area designations by one year. We refer to these documents announcing the delay collectively as the “Designations Delay.” (Page 10 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 11 of 47 230,000 asthma attacks in children, avoid hundreds of hospitalizations and emergency room visits, and prevent 160,000 missed school days for children. EPA, EPA-452/R-15-007, Regulatory Impact Analysis of the Final Revisions to the National Ambient Air Quality Standards for Ground-Level Ozone at ES-16, tbl.ES6 (2015), Ex.12 (“RIA”); see also id. ES-2 to -3. Substantial death and suffering will thus inevitably result from the Designations Delay. The Designations Delay is illegal and irrational. The statutory provision that EPA seized upon as ostensible ground for delaying implementation of the 2015 standards applies only where EPA “has insufficient information” to promulgate designations for one or more areas. 42 U.S.C. § 7407(d)(1)(B)(i). But EPA’s Designations Delay is devoid of any showing that the copious information already before the agency is somehow “insufficient.” Indeed, EPA did not even attempt such a showing. Instead, EPA tried to convert § 7407(d)(1)(B)(i) into a blanket authorization for delay on a broad mishmash of policy grounds irrelevant to the adequacy of information for designations, such as a desire to revisit the 2015 ozone standards themselves and alleged challenges in complying with the standards. Such concerns are untethered from § 7407(d)(1)(B)(i), the sole statutory authority EPA cited for its action. Because EPA’s Designations Delay is clearly unlawful and arbitrary, and because this unlawful deferral of the October 1, 2017, deadline for completing 2 (Page 11 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 12 of 47 designations is dangerous to public health, summary vacatur is appropriate. In the alternative, EPA’s Designations Delay should be stayed pending judicial review. In light of the severe health threats at stake, Petitioners further request that the case be expedited.2 BACKGROUND I. OZONE SERIOUSLY HARMS HUMAN HEALTH. Ozone, the main component of urban smog, is a corrosive air pollutant that inflames the lungs and constricts breathing. See Am. Trucking Ass’ns v. EPA, 283 F.3d 355, 359 (D.C. Cir. 2002) (“ATA”); EPA-HQ-OAR-2008-0699-0405 (“ISA”) 2-20 to -23 tbl.2-1, Ex.14. It causes asthma attacks, emergency room visits, hospitalizations, deaths, and other serious health harms. E.g., 80 FR 65,292, 65,308/3-09/1 (Oct. 26, 2015), Ex.11; EPA-HQ-OAR-2008-0699-0404 (“PA”) 318, 3-26 to -29, 3-32, Ex.13; ISA 2-16 to -18, 2-20 to -24 tbl.2-1. Ozone can harm healthy adults, but others are more vulnerable. See 80 FR 65,310/1-3. Because their respiratory tracts are not fully developed, children are especially vulnerable to ozone pollution, particularly when they have elevated respiratory rates, as when playing outdoors. E.g., PA 3-81 to -82. People with lung disease and the elderly also have heightened vulnerability. See 80 FR 65,310/3. People with asthma suffer 2 Petitioners requested EPA administratively stay the Designations Delay on July 5. Exs.16-19. EPA has not acted on that request. 3 (Page 12 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 13 of 47 more severe impacts from ozone exposure than healthy individuals do and are more vulnerable at lower levels of exposure. Id. 65,311/1 n.37, 65,322/3. II. THE CLEAN AIR ACT PRESCRIBES A CAREFULLY-DESIGNED PROGRAM FOR CONTROLLING OZONE POLLUTION. Bringing the entire country expeditiously into compliance with health- and welfare-protective air quality standards forms the driving “heart” of the Clean Air Act. Alabama Power Co. v. Costle, 636 F.2d 323, 346 (D.C. Cir. 1980). EPA must set “primary” and “secondary” standards for pollutants like ozone to protect public health and welfare, respectively. 42 U.S.C. §§ 7408(a), 7409(a)-(b). It must review and, as appropriate, revise these standards at least every five years. Id. § 7409(d)(1). In setting and revising them, EPA is barred from considering the costs and technological feasibility of implementing the standards. Whitman v. Am. Trucking Ass’ns, 531 U.S. 457, 471 & n.4 (2001); Am. Petroleum Inst. v. Costle, 665 F.2d 1176, 1185 (D.C. Cir. 1981). After EPA sets a standard, the implementation process begins, which, as relevant to this case, starts with initial area air quality designations. See ATA, 283 F.3d at 358-59. States and Tribes first submit recommended designations, and then, “as expeditiously as practicable,” but at the latest within two years of promulgating a standard, EPA “shall promulgate the designations of all areas (or portions thereof) submitted” by states and Tribes as either violating the standard 4 (Page 13 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 14 of 47 (“nonattainment” areas) or meeting the standard (“attainment” areas). 42 U.S.C. § 7407(d)(1)(A)-(B); see also id. §§ 7601(d)(1), 7602(d).3 The Act specifies the relevant considerations for making designations by specifically defining each type of area. For example, nonattainment areas are those that “do[] not meet (or that contribute[] to ambient air quality in a nearby area that does not meet)” a standard for a pollutant. Id. § 7407(d)(1)(A)(i). The Act provides only one condition under which EPA may extend its deadline for promulgating designations—when it “has insufficient information to promulgate the designations.” Id. § 7407(d)(1)(B)(i) (“Such period may be extended for up to one year in the event the Administrator has insufficient information to promulgate the designations.”). For nonattainment areas, Congress created a detailed program to ensure that air quality will attain ozone standards by specified deadlines (“attainment deadlines”). Id. §§ 7410(a), (c), 7502; see also id. §§ 7511-7511f (provisions specific to ozone nonattainment areas). Each state must adopt a “state implementation plan” that, for nonattainment areas, includes all the requirements Congress crafted for such areas. Id. § 7410(a)(2)(I). 3 There is a third designation—an “unclassifiable” area, which is “any area that cannot be classified on the basis of available information as meeting or not meeting” the standard—which is treated for regulatory purposes as an attainment area. See 42 U.S.C §§ 7407(d)(1)(A)(iii), 7471; see also Miss. Comm’n on Envtl. Quality v. EPA, 790 F.3d 138, 145 (D.C. Cir. 2015) (describing “unclassifiable” designation). 5 (Page 14 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 15 of 47 Crucially, the Act-required attainment deadlines are keyed to the date of designation. See NRDC v. EPA, 777 F.3d 456, 465-69 (D.C. Cir. 2014). The requirements—and deadlines—for states to adopt the specific programs Congress mandated to control harmful emissions in nonattainment areas similarly depend on the areas being designated nonattainment. See, e.g., 42 U.S.C. §§ 7502(b), (c), 7503 (general planning requirements for nonattainment areas kick in when area is designated nonattainment), 7511a(a)(2)(C) (requiring “new source review” permitting programs that require new and modified major factories and power plants in nonattainment areas to install state-of-the-art emission controls and compensate for emission increases with greater offsetting reductions), 7511a(b)(2) (requiring emission control on certain types of existing sources in certain nonattainment areas), 7511a(c)(2)(A) (for certain nonattainment areas, requiring plans demonstrating attainment of standard by applicable attainment deadline). Simultaneously with their designation, ozone nonattainment areas must be classified based on the severity of their ozone pollution levels. Id. § 7511(a)(1) tbl.1. The higher the classification, the longer the area has to come into attainment, but the more stringent the controls it must adopt. South Coast Air Quality Mgmt. Dist. v. EPA, 472 F.3d 882, 887 (D.C. Cir. 2006), amended in other parts 489 F.3d 1245 (D.C. Cir. 2007). If an area fails to attain timely, EPA must reclassify it to a higher classification, triggering stronger pollution control requirements. Id. 887-88 6 (Page 15 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 16 of 47 EPA’s promulgation of nonattainment designations is thus essential to triggering the Act’s nonattainment provisions and bringing about the attendant health and environmental benefits. Simply put, delay of designations delays the stronger pollution controls Congress mandated to protect people in communities with unhealthy air. III. EPA FINDS THE 2008 STANDARDS INADEQUATE AND PROMULGATES STRONGER STANDARDS. EPA revised the ozone standards most recently on October 1, 2015, strengthening them by tightening the maximum 8-hour level of ozone allowed in the ambient air to 70 parts per billion (ppb), down from the 75 ppb allowed under the 2008 standards. 80 FR 65,292/1, 65,452/2; 73 FR 16,436, 16,436/1 (2008). After a lengthy and detailed review process, EPA determined that the 2008 standards were inadequate to protect public health and welfare. 80 FR 65,342/247/1, 65,389/1-90/2. Important parts of the extensive record showed that healthy young adults experienced adverse health effects with ozone exposures at levels allowed by the 2008 standards and linked ozone levels allowed by those standards to hospital visits, deaths, and other serious health harms. Id. 65,343/1-44/3, 65,346/2-3. In a 15-city study, EPA estimated that tens of thousands of children would still face dangerous ozone exposures even after the 2008 standards were met. Id. 65,344/3-47/1. EPA’s independent scientific advisors likewise 7 (Page 16 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 17 of 47 unanimously found the 2008 standards were not strong enough to protect public health and welfare. Id. 65,346/2, 65,381/3. Multiple parties filed petitions in this Court challenging the 2015 standards, some arguing they were overly stringent, and others that they were insufficiently protective. See Murray Energy v. EPA, No. 15-1385 et al. (D.C. Cir.). Shortly before the scheduled oral argument in those consolidated cases, EPA sought to postpone it based on the agency’s stated desire for time to determine whether to reconsider the 2015 standards. EPA Mot. to Continue Oral Argument 5-6, Murray Energy, No. 15-1385 (D.C. Cir. Apr. 7, 2017). The Court held the case in abeyance, but the standards have not been stayed and remain in effect. Order, Murray Energy, No. 15-1385 (D.C. Cir. Apr. 11, 2017). EPA’s revision of the standards on October 1, 2015, meant its mandatory deadline for issuing designations is October 1, 2017. See 42 U.S.C. § 7407(d)(1)(B)(i). The Act prescribes a step-by-step process for promulgating designations. States must first submit recommended designations to EPA within one year of standards’ promulgation. Id. § 7407(d)(1)(A). EPA may modify a recommended designation, but must first provide the state 120 days’ notice and give the state an opportunity to rebut the proposed modification. Id. § 7407(d)(1)(B)(ii). 8 (Page 17 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 18 of 47 EPA, states, and Tribes have already undertaken the steps that traditionally have enabled EPA to meet prior designation deadlines. All the states and several Tribes submitted designation recommendations to EPA.4 The states and Tribes formulated these recommendations with guidance from EPA regarding what kind of information the agency needed to make the final designations. For example, drawing on its experience with past ozone standards, EPA promulgated a memorandum further describing the process for developing designations. Memorandum on Area Designations for the 2015 Ozone National Ambient Air Quality Standards, from Janet McCabe, Acting Ass’t Adm’r, to Reg’l Adm’rs (Feb. 25, 2016), Ex.10 (“Memorandum”).5 Among other things, EPA explained that it bases designations on air quality monitoring data—measurements of the amount of ozone actually present in the air at stations that sample the ambient air in locations consistent with EPA regulations. Memorandum 3; see Miss. Comm’n, 790 F.3d at 147 (upholding designations that used this approach for 2008 ozone standards). “After identifying each monitor that indicates a violation of the 2015 4 https://www.epa.gov/ozone-designations/2015-ozone-standards-staterecommendations; https://www.epa.gov/ozone-designations/2015-ozone-standardstribal-recommendations. 5 EPA also proposed a rule that would govern implementation of the 2015 standards. 81 FR 81,276 (Nov. 17, 2016). The comment period on that rule closed February 13, 2017. 81 FR 91,894, 91,894/1-2 (Dec. 19, 2016). 9 (Page 18 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 19 of 47 ozone NAAQS in an area, the EPA will determine which nearby areas contribute to the violation(s)” based on five factors used in prior designations. Memorandum 5-7 (factors are “air quality data, emissions and emissions-related data, meteorology, geography/topography, and jurisdictional boundaries,” with other factors potentially relevant for specific areas); see Miss. Comm’n, 790 F.3d at 149, 158-59 (same factors applied for initial area designations for 2008 standards). EPA explained that states would base designation recommendations on certified, quality-assured air quality monitoring data for 2013-15 (the years needed to calculate the official air quality statistic—“design value”—to assess compliance with the standards for 2015), with preliminary data for 2016 perhaps factoring in. Memorandum 2-4. EPA expected to base designations on the 2016 design value, which use 2014-16 data. Id. The 2015 design values, as measured at every air quality monitor in the country, were available in July 2016,6 and EPA regulations required full, accurate, and quality-assured data for 2016 by May 1, 2017. 40 C.F.R. § 58.15; see also Memorandum 3 (explaining regulations). 6 https://www.epa.gov/sites/production/files/201607/ozone_designvalues_20132015_final_07_29_16.xlsx. 10 (Page 19 of Total) USCA Case #17-1172 IV. Document #1683752 Filed: 07/12/2017 Page 20 of 47 EPA ABRUPTLY DELAYS IMPLEMENTING THE NEW STANDARDS. Without notice or public input, EPA extended its deadlines for promulgating designations by a year. First, on June 6, 2017, it sent identical four-paragraph letters to state governors so informing them. Exs.2-5; see also EPA, Administrator Extends Deadline for Area Designations for 2015 Ozone Standards (as updated June 7, 2017), Ex.6 (stating that EPA extended designations deadline “[i]n a letter to Governors”); EPA, EPA to Extend Deadline for 2015 Ozone NAAQS Area Designations (June 6, 2017), Ex.7 (press release announcing extension). The Delay Letter asserts potential concern about various purported “issues that could undermine…compliance efforts,” and that the delay gives “the Agency time to complete its review” of the 2015 standards, but nowhere explains why the information it already has is inadequate to promulgate designations. Delay Letter 1. EPA subsequently announced its delay action in the Federal Register. 82 FR 29,246 (“Notice”). The Notice’s single-paragraph explication for the Designations Delay rehashes similar claims as the Delay Letters, but with some minor variations. It first baldly claims that because of various “issues regarding the 2015 ozone NAAQS and its implementation,” EPA “cannot assess whether [the Administrator] has the necessary information to finalize designations.” 82 FR 29,247/2. It also contends that because of the ongoing review of the standards, EPA lacks sufficient information to promulgate designations. Id. 29,247/3. EPA 11 (Page 20 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 21 of 47 again provides no explanation of what specific information it lacks to allow it to promulgate designations. ARGUMENT I. THE DESIGNATIONS DELAY IS UNLAWFUL AND ARBITRARY AND SHOULD BE SUMMARILY VACATED. The Designations Delay is flagrantly illegal and arbitrary.7 EPA relied solely on a narrow Clean Air Act provision that allows EPA to delay nonattainment designations by up to one year only when it “has insufficient information to promulgate the designations.” 42 U.S.C. § 7407(d)(1)(B)(i). But EPA nowhere identified any insufficiency of information of the sort that, under the statute, is the sole permissible basis for a delay. The factors EPA cited are extraneous to the statutory criterion, instead addressing EPA’s desire to reconsider the standards and to examine compliance issues. EPA also failed to explain why, assuming it had explained what relevant information was lacking for any area, it was delaying designations for the entire country for an entire year, despite the Act’s mandate for expeditious designation promulgation. EPA’s attempt to convert a narrow statutory provision into a broad authorization for delay is contrary to the plain, limited language of the Act and 7 This Court must set aside EPA actions that are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). 12 (Page 21 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 22 of 47 would thwart Congress’s framework for deadline-driven attainment of health standards. Because EPA’s Designations Delay is clearly unlawful, arbitrary, and dangerous to public health, and particularly given the imminent October 2017 statutory deadline for EPA to complete the designations, summary vacatur is appropriate. See Clean Air Council v. EPA, No. 17-1145, slip op. 10-11 (D.C. Cir. July 3, 2017). A. EPA Has Not Satisfied the Statutory Requirements for Delaying Designations. EPA does not even attempt to tether its purported rationale for the Designations Delay to the statutory prerequisite for such action—insufficient information to allow it to make designations. EPA has up to two years to promulgate designations, with the sole basis for extending that deadline (for up to a year) being where EPA “has insufficient information to promulgate the designations.” 42 U.S.C. § 7407(d)(1)(B)(i). Under the Act, the only bases for making designations are whether an area fails to meet the standards (a simple numerical comparison based on data EPA has) and whether it contributes to another area’s failure to meet the standards: if an area meets either condition, it is a nonattainment area; otherwise, it is an attainment area. Id. § 7407(d)(1)(A)(i)-(ii) (defining “nonattainment” and “attainment” area). The information needed to promulgate designations is thus information about air quality at monitoring sites 13 (Page 22 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 23 of 47 and information about what areas affect air quality in nearby areas with monitors that violate the standards. See id. § 7407(d)(1)(A)(i)-(iii).8 Yet EPA illegally seeks to justify the Designations Delay based on considerations unrelated to these factors. See Massachusetts v. EPA, 549 U.S. 497, 535 (2007) (“EPA must ground its reasons for action or inaction in the statute.”). EPA centrally relies on the irrelevant fact that it is reviewing the standards themselves, closing the Notice by saying: We also note that new agency officials are currently reviewing the 2015 ozone NAAQS rule. The Administrator has determined that in light of the uncertainty of the outcome of that review, there is insufficient information to promulgate designations by October 1, 2017. 82 FR 29,247/3. The Agency says that, “[a]s part of the review process,” it is examining purported “issues that could undermine associated compliance efforts,” which are background ozone levels,9 ozone originating abroad, and “exceptional events demonstrations.”10 Delay Letter 1 (emphasis added); accord 82 FR 29,247/2 8 See also Memorandum 3-7 (describing EPA’s intended practice); Miss. Comm’n, 790 F.3d at 147, 149, 158-59 (describing EPA’s historical practice). 9 EPA uses the term “background” to mean ozone pollution caused by natural phenomena anywhere or by human-caused emissions outside the United States. 80 FR 65,328/1 (“U.S. background” means ozone “that would exist even in the absence of any manmade emissions within the United States”). 10 “Exceptional events” are certain events that were shown to clearly cause exceedances of standards but were “not reasonably controllable or preventable” 14 (Page 23 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 24 of 47 (citing most of the same issues as ones EPA is “evaluating…regarding the 2015 ozone NAAQS and its implementation”). EPA frames the Designations Delay as purportedly justified “[i]n light of the analyses currently underway at the agency.” 82 FR 29,247/3. But, though EPA is free to engage in such analyses, review of the standards and supposed compliance-related considerations is wholly divorced from the sufficiency of the information about actual air quality conditions that is relevant to making designations under these still-effective standards. See, e.g., Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins., 463 U.S. 29, 43 (1983). Indeed, Congress required EPA to review standards at least every five years, 42 U.S.C. § 7409(d)(1), so Congress cannot possibly have meant to include such reviews as a justification for one-year delays. Otherwise, EPA could halt the “engine that drives nearly all of Title I of the [Clean Air Act]” by repeatedly revising and then reviewing standards, Whitman, 531 U.S. at 468. This interpretation cannot be reconciled with the Act. See id. 485 (rejecting as unreasonable statutory interpretation that would allow EPA to “abort[]” ozone nonattainment provisions of Clean Air Act “the day after [provisions were] enacted”); South Coast, 489 F.3d at 1248 (rejecting as “absurd” statutory and “caused by human activity that is unlikely to recur at a particular location or a natural event.” 42 U.S.C. § 7619(b). Data resulting from such events may be excluded from air quality monitoring data used to determine if an area violated the standards. Id. 15 (Page 24 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 25 of 47 interpretation that would allow EPA to take trivial actions and “avoid ever implementing” Act-mandated pollution controls). Moreover, EPA cannot base a delay on mere speculation that it might have insufficient information. 82 FR 29,247/2-3 (claiming EPA cannot determine if it has “necessary,” “sufficient information to finalize designations” because of review). Congress required EPA to promulgate designations “as expeditiously as practicable” and authorized delay only where EPA rationally finds the information is actually “has” is inadequate to make designations. 42 U.S.C. § 7407(d)(1)(B)(i). EPA’s assertion here that it might have inadequate information is not such a finding. See In re Harman Int’l Indus. Sec. Litigation, 791 F.3d 90, 103 (D.C. Cir. 2015) (pointing out “important difference between warning that something ‘might’ occur and that something ‘actually had’ occurred” (emphasis in original)); see also Moncrieffe v. Holder, 133 S. Ct. 1678, 1688 & n.8 (2013) (rejecting analysis that looks at what “could have” or “would have” happened, not what did happen). Because EPA has not found the information it has is insufficient, it cannot lawfully or rationally grant itself an extension under § 7407(d)(1)(B)(i). See Chamber of Commerce v. SEC, 412 F.3d 133, 143-44 (D.C. Cir. 2011) (where Congress requires agency to make certain assessment, agency must do so). EPA also says it seeks more time to “consider completely all designation recommendations provided by state governors…and to rely fully on the most 16 (Page 25 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 26 of 47 recent air quality data.” Delay Letter 1; see also 82 FR 29,247/2-3 (claiming EPA needs time to consider such materials because of (statutorily irrelevant) review of “issues regarding the 2015 ozone NAAQS and its implementation”). But those excuses do not relate, nor do they even claim to relate, to the sufficiency of the information EPA possesses. EPA raises no concern about the sufficiency of the designation recommendations or any concern about the sufficiency of the air quality data before it. Because EPA’s decision “rests on reasoning divorced from the statutory text,” it is unlawful and arbitrary. Massachusetts, 549 U.S. at 532-33; see NRDC v. EPA, 777 F.3d at 468-69 (where EPA “explanation lacks any grounding in the statute,” it is unlawful).11 B. EPA’s Purported Justifications for the Delay Are Arbitrary and Unlawful. “Where, as here, Congress has delegated to an administrative agency the critical task of assessing the public health and the power to make decisions of national import in which individuals’ lives and welfare hang in the balance, that agency has the heaviest of obligations to explain and expose every step of its reasoning.” American Lung Ass’n v. EPA, 134 F.3d 388, 392 (D.C. Cir. 1998). 11 Even if the statute were not so unambiguous, EPA’s attempt to import factors irrelevant to the adequacy of information would be due no deference, as it did not adopt that reading through any formalized or well-considered process. See, e.g., United States v. Mead Corp., 533 U.S. 218, 228 (2001). 17 (Page 26 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 27 of 47 Here, EPA has not explained how the information it has is insufficient to promulgate designations. Nor has it explained how the purported “issues” implicated by its review of the 2015 standards relate to the adequacy of the information it has for making designations. EPA identifies no way in which “background ozone levels” or “international transport” are relevant to designations, nor can it. 82 FR 29,247/2; see supra p.14, n.9 (EPA defines “background” as ozone resulting from anything other than human-caused emissions within the United States). Indeed, the Act specifically deals with international transport at the post-designation stage, during actual implementation. See 42 U.S.C. § 7509a(a)(b). Addressing it at the designation stage would thus conflict with Congress’s careful implementation design. EPA’s speculation that it might find new approaches for states to comply with the standards is utterly irrelevant to the issue of whether communities are currently meeting or violating the standards. 82 FR 29,247/2-3 (discussing new “Ozone Cooperative Compliance Task Force” (emphasis added)). The Designations Delay is thus arbitrary. Even if EPA’s stated bases for wanting more time were statutorily relevant, its reliance on them here was arbitrary. EPA claimed it cannot even tell if the information it has is insufficient, id. 29,247/2, but it has provided no explanation, much less a rational one, about why it cannot assess the information it has when it has all the information the statute and its own guidance say EPA needs. See supra 18 (Page 27 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 28 of 47 pp.9-10; Letter from Dannel Malloy, Gov. of Conn., to Scott Pruitt, Adm’r, EPA, at 3 (June 20, 2017) (“There is nothing missing from past information used by EPA to designate areas after previous revisions to the ozone NAAQS.”), Ex.9. Also, EPA has already had months to consider the designation recommendations the states provided—all but one were submitted by mid-October 2016. See https://www.epa.gov/ozone-designations/2015-ozone-standards-staterecommendations. The last one was submitted in March 2017, but it is three sentences long, with the only substantive sentence consisting of the recommendation that EPA designate the same areas nonattainment under the 2015 standards as it did under the 2008, with the same boundaries. Letter from Larry Hogan, Gov. of Maryland, to Cecil Rodrigues, Acting Regional Adm’r (Mar. 23, 2017), https://www.epa.gov/sites/production/files/201705/documents/md_recommendations.pdf. It is hardly credible for EPA to claim it requires an entire year to “consider completely” information it has had for months. As well as being irrelevant, EPA’s claim that, because of the review of issues regarding the standards, it needs more time to consider “exceptional events impacting designations” as part of considering the state recommendations, 82 FR 29,247/3, is unsupported. EPA identifies no rational connection between the review and the level of consideration needed for such exceptional events. Nor does EPA cite any specific instances where attainment designations hinge on timely 19 (Page 28 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 29 of 47 submitted, yet unresolved claims of exceptional events. Even if there are such claims, EPA fails to show it lacks adequate information to resolve them before the October 1 designations deadline. Even after the announcement in April 2017 of the review, EPA swiftly fully processed and granted an exceptional event petition dated April 14, 2017. EPA-HQ-OAR-2017-0223-0004 (granting petition via letter dated May 30, 2017), Ex.8. Thus, the record evidence contradicts EPA’s claim that it needs more time, rendering the claim arbitrary. See Nat’l Lime Ass’n v. EPA, 233 F.3d 625, 634-35 (D.C. Cir. 2000). Nor does EPA’s claim about needing time to “rely fully on the most recent air quality data,” Delay Letter 1, have any record basis. Those data were due to be certified by May 1, 2017, a month before EPA decided to extend the deadline and five months before the October 1 designation deadline. 40 C.F.R. § 58.15. EPA has provided no explanation why those periods are inadequate. To the contrary, EPA has previously made ozone designations only two months after receiving certified data. See 77 FR 30,088, 30,091/3, 30,095/2 (2012) (EPA finalized some designations on Apr. 30, 2012, using data certified by Feb. 29, 2012); see also Miss. Comm’n, 790 F.3d at 157-58. Thus, as well as failing to claim that it actually lacks the most recent air quality data, EPA has not made any rational claim that it lacked time to consider that information. See Sorenson Comms. v. FCC, 755 F.3d 20 (Page 29 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 30 of 47 702, 709 (D.C. Cir. 2014) (rule is arbitrary and capricious where it “is not only unsupported by the evidence, but contradicted by it”). Further, EPA’s generic desire to consider new information cannot be reconciled with the Act’s requirement that EPA promulgate designations “as expeditiously as practicable,” with delay allowed only where the information EPA “has” is “insufficient,” 42 U.S.C. § 7407(d)(1)(B)(i). EPA here contravenes Congress’s command by delaying designations without explaining why the existing information is insufficient. EPA itself has recognized that it cannot keep waiting for new information instead of making designations, explaining during the designations process for the 2008 standards that “‘[n]ew technical data become available on a regular basis,’” so “delay ‘to consider such new information would result in a never-ending process in which designations are never finalized.’” Miss. Comm’n, 790 F.3d at 158 (quoting letter from EPA Administrator) (alteration in original). In an analogous circumstance, where a statute required EPA to use the “best available evidence,” this Court has already held that “EPA cannot reject the ‘best available’ evidence simply because of the possibility of contradiction in the future by evidence unavailable at the time of action—a possibility that will always be present.” Chlorine Chemistry Council v. EPA, 206 F.3d 1286, 1290-91 (D.C. Cir. 2000) (emphasis in original). So too here: EPA’s preference to wait for more evidence is inconsistent with the Act and arbitrary. 21 (Page 30 of Total) USCA Case #17-1172 C. Document #1683752 Filed: 07/12/2017 Page 31 of 47 Even If Some Delay Could Be Justified for Some Areas, EPA Has Not Justified the Across-the-Board One-Year Delay It Granted Itself. Even if some information for some areas were insufficient—a claim EPA has not made or supported—EPA has not explained why a one-year extension for all areas is justified. The Act instructs EPA to make designations “as expeditiously as practicable,” and the length of any extension beyond the two-year outer deadline is limited to being “up to one year.” 42 U.S.C. § 7407(d)(1)(B)(i) (emphasis added). Thus, a one-year extension is not a default: it is an outer bound, with EPA obligated to move as quickly as practicable to promulgate designations. Here, EPA has given no explanation why a full year’s extension is rationally justified anywhere, let alone for every single area of the nation. That is arbitrary. See American Lung, 134 F.3d at 392. Further, because EPA failed to address the statutory requirement to designate as expeditiously as practicable, the Designations Delay is unlawful and arbitrary. See Public Citizen v. Fed. Motor Carrier Safety Admin., 374 F.3d 1209, 1216 (D.C. Cir. 2004). EPA claims that its review of certain issues relating to the standards and their implementation, like background ozone levels, international transport of ozone pollution, and exceptional events, affects its ability to make designations. 82 FR 29,247/2-3. Even if that were true—and it patently is not, see supra pp.14-15— EPA has not explained why those issues are relevant over every square inch of the 22 (Page 31 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 32 of 47 nation. To the contrary, EPA identified no specific area where any such issue precluded rational designations. Far from claiming that background ozone levels are high enough to matter for regulatory purposes everywhere in the country, EPA has made clear that “the locations that are most strongly influenced by background [ozone] are relatively limited in scope, i.e., rural areas in the intermountain western U.S.” EPA-HQOAR-2008-0699-4309 at 347 (EPA Response to Comments on establishment of 2015 standards). The same holds for international transport. 80 FR 65,328/2. Nor does the Designations Delay identify any specific area where designation hinges on an unresolved claim that exceedances of the standards resulted from exceptional events, much less that such claims exist for every area of the nation. EPA has thus failed to explain why it chose to delay designations for the entire country. See, e.g., Sorenson Comms., 755 F.3d at 709. If EPA lacked sufficient information for certain areas, EPA arbitrarily failed to consider its time-tested alternative to a national delay. In prior designations, EPA has issued designations for certain areas while deferring designations for others for which it lacked sufficient information. For example, in making designations under the 2012 particulate matter standards, EPA extended its deadline for 10 specific areas where it had insufficient monitoring data “to determine whether the areas are meeting or are not meeting the [standards],” and 23 (Page 32 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 33 of 47 an additional year would give it those data, but EPA promulgated designations for the rest of the country, for which it had data or for which an additional year’s worth of data would still be insufficient. 80 FR 2206, 2207/3 (Jan. 15, 2015); see also 75 FR 71,033, 71,035/3-36/1 (2010) (similar for designations under 2008 lead standard). Assuming there were some (unexplained) factual basis for EPA’s concerns about the completeness of its information, it was arbitrary for EPA not even to consider the option of making some designations but deferring others. E.g., State Farm, 463 U.S. at 46-48 (agency failure to consider reasonable alternative renders its action arbitrary); Del. Dep’t of Nat. Res. v. EPA, 785 F.3d 1, 17-18 (D.C. Cir. 2015) (where EPA failed to consider “reasonable alternatives” to uniform national rule, “its action was not rational and must, therefore, be set aside”). II. IN THE ALTERNATIVE, THE COURT SHOULD STAY THE DESIGNATIONS DELAY. If the Court does not summarily vacate the Designations Delay, it should stay EPA’s action pending merits review. A stay’s issuance depends on balancing four factors: (1) petitioners’ likelihood of success on the merits; (2) whether petitioners will suffer irreparable harm without a stay; (3) whether a stay will substantially harm other parties; and (4) the public interest. D.C. Cir. R.18(a)(1); see, e.g., League of Women Voters v. Newby, 838 F.3d 1, 6 (D.C. Cir. 2016). As 24 (Page 33 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 34 of 47 discussed above, the Designations Delay is clearly illegal and arbitrary, meaning the first factor strongly favors Petitioners. As discussed below, so do the other three. A. The Designations Delay Will Irreparably Harm Petitioners. Unless this Court summarily vacates the Designations Delay, judicial review in this case will mostly likely extend well beyond October 1, 2017, the date by which, under the Act, EPA must promulgate designations. Without a stay pending judicial review, Petitioners’ members face a substantial likelihood of irreparable harm resulting from the Designations Delay. By delaying designations, EPA delays pollution controls required by the Act to curb ozone levels EPA agrees are unsafe in communities where Petitioners’ members live, work, and enjoy recreation. Such communities include areas currently designated as attainment under the 2008 standards but whose ozone levels violate the 2015 standards; because of the Designations Delay, they will not be timely designated nonattainment and thus will lack the anti-pollution protections that a nonattainment designation would accord them. See supra pp.6-7; Berman Decl. ¶¶ 17-34, Ex.23; Craft Decl. ¶ 14, Ex.27. These important protections include measures states adopt into their implementation plans to limit emissions of ozone-forming chemicals sufficiently for the area to come into attainment, as well as attainment deadlines, nonattainment new source review for 25 (Page 34 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 35 of 47 new or modified major sources of pollution, like factories and power plants, and pollution controls for large existing plants. These delays will irreparably harm Petitioners’ members by prolonging their exposure to ozone levels EPA has found cause deaths, asthma attacks in children, emergency room visits, hospitalizations, and other serious health harms. RIA at ES-16 tbl.ES-6; see also id. ES-2 to -3. The attached Declarations, Exs.20-46, demonstrate the human impacts of these harms. Krystal Henagan is a member of Petitioners Environmental Defense Fund and Sierra Club living in San Antonio, a city with ozone levels that violate the 2015 standards, but is designated attainment under the 2008 standards. Henagan Decl. ¶¶ 1-2, 4, Ex.34; Berman Decl. ¶ 19. She struggles with her 8-year-old son’s asthma, which is controlled by four medications, and which has been “life threatening” in the past. Henagan Decl. ¶¶ 59, 12. Her son regularly must go to the doctor—12 visits in 2017 alone—and “he has missed countless school days due to poor air quality exacerbating his asthma,” days during which Ms. Henagan must stay home and care for him. Id. ¶¶ 7-12. She fears he will suffer asthma attacks or that she “would need to rush him to the hospital due to his inability to breathe.” Id. ¶ 8. Rhonda Anderson, a Sierra Club member living and working in Detroit (also a city with ozone levels that violate the 2015 standards, but designated attainment under the 2008 standards, Berman Decl. ¶ 19), a grandmother, and a senior with 26 (Page 35 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 36 of 47 asthma, describes how, even as an adult, she has had to go to the hospital because of her asthma, and her daughters and granddaughters have similarly had to go (both as adults and as children). Anderson Decl. ¶¶ 4-6, Ex.21. She describes the trauma of going to the emergency room because of a child’s asthma attack: Often, I have spent no less than 4 hours waiting, all the while wondering when my child will be able to see the doctor. Once we are called, we get sent to a second crowded room with breathing machines, and every station is filled with a child having an asthma attack. It is very stressful and there is nothing that can take my mind off the fact that I have a sick child that I cannot help. Id. ¶ 6. Family members and others she knew have died from asthma attacks. Id. ¶ 8. Other declarants further detail how the health harms ozone causes affect them. Nsedu Obot Witherspoon, a member of the American Public Health Association, has a seven-year-old son with asthma. Witherspoon Decl. ¶ 5, Ex.46. He endured “his first bad asthma attack at just three years old,” so bad that when they got to the doctor, they said his oxygen levels were so low that we had to leave our car and go immediately to the ER in an ambulance. This was one of the scariest moments of my life. He was hospitalized for two nights. He was again hospitalized at the age of four. Id. Even now, despite “a rigorous asthma management plan with frequent checkups at the pediatrician’s office,” “his asthma acts up…frequently…when air quality is bad.” Id. ¶ 6. “[H]e often has to slow down or sit out on high air pollution days,” 27 (Page 36 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 37 of 47 instead of playing outside or walking or hiking with his siblings and parents. Id. ¶¶ 3-4, 7. Petitioners’ members living, working, and recreating in areas attaining the 2008 standards, but with ozone levels that violate the 2015 standards routinely find their ability to breathe impaired (see, e.g., Anderson Decl. ¶¶ 4-5; Brock Decl. ¶ 5 (Atlanta area), Ex.24; Einzig Decl. ¶¶ 3-5 (Baltimore), Ex.30; see also Berman Decl. ¶¶ 19, 22-23) and their ability to work and their children’s ability to attend school impeded (see, e.g., Einzig Decl. ¶ 8; Henagan Decl. ¶¶ 6-7). Because of their health concerns, they must refrain from outdoor activities they would otherwise enjoy. See, e.g., Seal Decl. ¶ 10 (San Antonio), Ex.41; Einzig Decl. ¶ 7. Petitioners have tens of thousands of other members residing in such areas. See Stith Decl. ¶ 10, Ex.42; Berman Decl. ¶¶ 19, 22 & attach.1. Because the attainment deadlines run from the date of designation, see supra p.6, the ozone pollution levels in these areas will be allowed to remain at dangerously elevated levels for an additional year because of EPA’s year-long Designations Delay unless this Court stays EPA’s unlawful action. See Craft Decl. ¶ 14. Petitioners’ members living in such areas, who experience severe harms to their health and wellbeing because of ozone pollution, will thus be harmed both by the delay in mandatory pollution reductions and by the additional year that they will have to endure dangerous ozone levels. 28 (Page 37 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 38 of 47 Even in areas violating both the 2008 and 2015 standards, the Designations Delay means Petitioners’ members there will receive neither the benefits of pollution reductions designed to drive compliance with the new, more protective 2015 standards nor the benefit of actual compliance with those standards as soon as they would absent the Designations Delay. For example, Jane Reardon, a nurse and member of Petitioner American Lung Association’s board, lives and works in Hartford County, Connecticut, caring for patients “who are hospitalized as a result of respiratory ailments,” including “many…patients…older than 65, like [her].” Reardon Decl. ¶¶ 1, 5-6, Ex.39; see also id. ¶ 7 (describing activities she engages in outdoors near her home, thus exposing her to dangerous ozone pollution). Hartford County violates both the 2008 and 2015 standards. Id. ¶¶ 1, 5; Berman Decl. ¶¶ 17, 30. As a result of the Designations Delay, implementation of the 2015 standards in Hartford County will be delayed a year, and the area’s attainment deadline will, too, thus endangering her health and her patients’ health. Reardon Decl. ¶ 8; see also Lyon Decl. ¶¶ 4-5 (describing how patients in Philadelphia with lung disease must miss medical appointments because poor air quality causes symptoms to flare up). Accordingly, the harms described above affect even more of Petitioners’ members. These human health harms resulting directly from EPA’s Designations Delay are irreparable, for ultimate success on the merits cannot undo them: no 29 (Page 38 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 39 of 47 court order can enable EPA to raise the dead, undo asthma attacks, reverse a hospitalization, or restore a missed day in the classroom or at work. See Wisc. Gas Co. v. FERC, 758 F.2d 669, 674 (D.C. Cir. 1985). Petitioners’ members, their families, and, for medical professionals, their patients have demonstrated heightened vulnerability to ozone pollution and already experience serious harms from it. The harms to them absent a stay are “likely,” as well as “certain and great,” “actual and not theoretical,” “beyond remediation,” and so “imminent that there is a clear and present need for equitable relief to prevent irreparable harm.” League of Women Voters, 838 F.3d at 6-8; see also Coleman v. Paccar, Inc., 424 U.S. 1301, 1307-08 (1976) (Rehnquist, J., in chambers) (finding “irreparable harm” where lower court stay of motor vehicle safety standards would delay “for a year or more” “[e]ffective implementation…of the congressionally mandated” program to “reduce traffic accidents and deaths and injuries”). Likewise, the Designations Delay is substantially likely to cause irreparable environmental harms, including to places Petitioners’ members use and enjoy. See Kodish Decl. ¶¶ 2-6, 9-14, Ex.35; Toher Decl. ¶¶ 3-8, Ex.43. Ozone damages vegetation and forested ecosystems, causing or contributing to widespread stunting of plant growth, tree deaths, visible leaf injury, reduced carbon storage, and damage to entire ecosystems. PA 5-2 to -3; ISA 9-1; 80 FR 65,370/1-2, 65,377/3. EPA acknowledges that, “[i]n terms of forest productivity and ecosystem diversity, 30 (Page 39 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 40 of 47 ozone may be the pollutant with the greatest potential for region-scale forest impacts.” RIA 7-3. Such widespread vegetation and ecosystem losses are irreparable, as they cannot “be adequately remedied by money damages” and are of “permanent or at least of long duration.” Amoco Production Co. v. Village of Gambell, 480 U.S. 531, 545 (1987). In short, without a stay pending judicial review, EPA will delay initial area designations beyond what the statute allows, making for a longer period of time that Petitioners’ members will be exposed to excessive amounts of air pollution that causes them serious harms. There can be “no do over and no redress” later, League of Women Voters, 838 F.3d at 9, for the irreparable health and environmental harms that Petitioners’ members (and the broader public) are virtually certain to experience absent a stay.12 B. A Stay Will Not Harm Other Parties. As the agency responsible for the proper execution of the Clean Air Act, EPA cannot be substantially harmed by a stay that would prevent it from giving effect to an illegal and arbitrary action. See Nat’l Ass’n of Farmworkers Orgs. v. Marshall, 628 F.2d 604, 615 (D.C. Cir. 1980) (“consequences [that] are no 12 For similar reasons, Petitioners have standing to challenge the Designations Delay. See Declarations. 31 (Page 40 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 41 of 47 different from [agency’s] burdens under the statutory scheme” “do not constitute substantial harm for the purpose of delaying injunctive relief”). Moreover, a stay would not prevent EPA from reviewing the 2015 standards or their implementation. The Act plainly contemplates that EPA will implement ozone standards even as it reviews them. Indeed, the Act puts the ozone standards on an implementation schedule that can last up to 20 years, while requiring EPA to review standards at least every 5 years. Whitman, 531 U.S. at 485 (“Congress knew” EPA could review ozone standards at any time, but still established implementation framework “reaching…far into the future”) (discussing 42 U.S.C. §§ 7409(d)(1), 7511(a), and 7511a). Thus, EPA would not experience harm from this Court’s staying the Designations Delay. C. The Public Interest Strongly Favors Staying the Designations Delay. EPA projects that compliance with the 2015 standards will realize significant health benefits. Outside of California, EPA estimates that compliance with the standards will result in upwards of 600 lives saved, over 250 heart attacks avoided, about 1,000 hospital admissions or emergency room visits prevented, 230,000 asthma attacks in children prevented, and 160,000 school loss days for children averted each year. RIA at ES-16 tbl.ES-6. The economic value of these benefits substantially outweighs the costs of achieving them. Id. ES-15 tbl.ES-5. In 32 (Page 41 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 42 of 47 making its estimate of public health benefits, EPA assumed designations would be completed in late 2017. See id. ES-2 to -3. These health benefits would come on top of the public health gains from achieving the 2008 standards and from several other pollution reduction requirements EPA put in place around the time it finalized the 2015 standards. Id. 6-1 (“The benefits…are estimated as being incremental to attaining the existing standard of 75 ppb…. These estimated benefits are incremental to the benefits estimated for several recent rules….”). These protections are already years overdue. EPA’s deadline for reviewing and revising the 2008 standards fell in March 2013. See 42 U.S.C. § 7409(d)(1) (five-year review cycle); 73 FR 16,436 (standards promulgated in March 2008). EPA acted over 18 months late, and only after being sued (a suit in which it requested still more time to finalize its review and revision of the 2008 standards). Order 1-2, Sierra Club v. EPA, No. 13-cv-2809 (N.D. Cal. Apr. 30, 2014) (rejecting timeframe EPA sought for finishing rulemaking). Delaying the designations will cause serious harm to the breathing public and to the environment. See supra pp.25-31; Craft Dec. ¶ 14 (delaying designations will “lead to a longer period of inaction before measures to abate health-harming ozone are undertaken in these heavily impacted areas,” resulting in “delayed attainment and more exposure to ground-level ozone,” resulting in “more asthma attacks, hospitalizations, emergency room visits, and premature deaths in those areas”). 33 (Page 42 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 43 of 47 On the other side of the ledger, industry and states are not cognizably harmed by having to comply with the ozone implementation program Congress enacted. See, e.g., League of Women Voters, 838 F.3d at 12 (“There is generally no public interest in the perpetuation of unlawful agency action.”). Moreover, history shows this country can have both economic growth and air pollution reductions. See, e.g., https://gispub.epa.gov/air/trendsreport/2016/#econ_growth_cleaner_air_ (over 1970-2015, emissions of the six pollutants most directly limited by national ambient air quality standards decreased 71%, and gross domestic product increased nearly 250%), Ex.15. The public interest thus strongly favors staying the Designations Delay. The Designations Delay means that Congress’s carefully-refined ozone nonattainment provisions will not engage as quickly as EPA assumed in its regulatory analysis. The pollution reductions they are specifically designed to assure will not occur as quickly, either. Thus, without a stay, compliance with the standards will be delayed, and Congress’s promise to all residents of this country that they will have safe air to breathe will go unfulfilled even longer than it already has. Significant numbers of lives will be needlessly worsened or lost as a result. Such an outcome flouts the public interest and the purpose of the Clean Air Act. Union Elec. v. EPA, 427 U.S. 246, 256 (1976) (Clean Air Act is “a drastic remedy to what was perceived as a serious and otherwise uncheckable problem of air pollution”). 34 (Page 43 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 44 of 47 CONCLUSION For the foregoing reasons, Petitioners respectfully request summary vacatur of the Designations Delay or, in the alternative, a stay of the Designations Delay and expedited review, see D.C. Cir., Handbook of Practice and Internal Procedures 33 (Jan. 26, 2017). DATED: July 12, 2017 /s/Ann Brewster Weeks (w/permission) Ann Brewster Weeks Clean Air Task Force 18 Tremont St., Ste. 530 Boston, MA 02108 (617) 624-0234 aweeks@catf.us Counsel for Clean Air Council and Ohio Environmental Council Respectfully submitted, /s/Seth L. Johnson Seth L. Johnson Laura Dumais David S. Baron Earthjustice 1625 Massachusetts Ave., NW Suite 702 Washington, DC 20036 (202) 667-4500 sjohnson@earthjustice.org ldumais@earthjustice.org dbaron@earthjustice.org Counsel for American Lung Association, American Public Health Association, American Thoracic Society, National Parks Conservation Association, Natural Resources Defense Council, Physicians for Social Responsibility, Sierra Club, and West Harlem Environmental Action 35 (Page 44 of Total) USCA Case #17-1172 Document #1683752 /s/Scott Strand (w/permission) Scott Strand Environmental Law and Policy Center 15 South Fifth St., Suite 500 Minneapolis, MN 55402 (612) 386-6409 sstrand@elpc.org Counsel for Environmental Law and Policy Center Filed: 07/12/2017 Page 45 of 47 /s/Sean H. Donahue (w/permission) Sean H. Donahue Susannah L. Weaver Donahue & Goldberg, LLP 1111 14th Street, NW, Ste. 510A Washington, DC 20005 (202) 569-3818 sean@donahuegoldberg.com susannah@donahuegoldberg.com Peter Zalzal Graham McCahan Rachel Fullmer Environmental Defense Fund 2060 Broadway, Suite 300 Boulder, CO 80302 (303) 447-7214 pzalzal@edf.org gmccahan@edf.org rfullmer@edf.org Counsel for Environmental Defense Fund 36 (Page 45 of Total) USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 46 of 47 CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME LIMIT Counsel hereby certifies, in accordance with Federal Rules of Appellate Procedure 32(g)(1) and 27(d)(2) and D.C. Circuit Rule 18(b), that the foregoing Motion for Summary Vacatur or, in the Alternative, for Stay Pending Judicial Review contains 7,760 words, as counted by counsel’s word processing system, and thus complies with the 7,800 word limit. Further, this document complies with the typeface and type-style requirements of Federal Rule of Appellate Procedure 32(a)(5) & (a)(6) because this document has been prepared in a proportionally spaced typeface using Microsoft Word 2010 using size 14 Times New Roman font. DATED: July 12, 2017 /s/Seth L. Johnson Seth L. Johnson (Page 46 of Total) USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 454 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 Kansas Kansas Kansas Kansas Kansas Leavenworth Neosho Sedgwick Sedgwick Shawnee 2010 METROPOLITAN 1500 WEST SEVENTH HEALTH DEPT., 1900 EAST 9TH ST. 12831 W. 117N 2501 RANDOLPH AVENUE 39.327391 37.676960 37.702066 37.897506 39.024265 -94.951020 -95.475940 -97.314847 -97.492083 -95.711275 99 98 99 100 100 100 99 100 99 99 98 99 100 98 99 99 99 100 99 99 0.068 0.062 0.069 0.068 0.064 0.060 0.061 0.064 0.063 0.062 0.062 0.061 0.062 0.062 0.063 0.063 0.061 0.065 0.064 0.063 Kansas Sumner -97.366399 100 100 97 99 0.067 0.065 0.062 0.064 Kansas Trego 707 E 119TH ST SOUTH,PECK COMMUNITY BLDG 37.476890 CEDAR BLUFF RESERVOIR,PRONGHORN & MULEY 38.770081 -99.763424 96 95 98 96 0.068 0.063 0.058 0.063 Kansas Kentucky Wyandotte Bell 1210 N. 10TH ST.,JFK RECREATION CENTER 1420 DORCHESTER AVENUE 39.117219 36.608430 -94.635605 -83.736940 95 96 98 99 100 99 98 98 0.063 0.062 0.063 0.059 0.064 0.062 0.063 0.061 Kentucky Boone 38.918330 -84.852637 100 99 98 99 0.062 0.062 0.065 0.063 Kentucky Boyd KY 338 & LOWER RIVER ROAD FIVCO HEALTH DEPARTMENT, 2924 HOLT STREET 38.459340 -82.640410 100 98 98 99 0.065 0.069 0.066 0.066 Kentucky Bullitt SECOND & CARPENTER STREETS 37.986290 -85.711920 90 98 96 95 0.065 0.067 0.067 0.066 Kentucky Campbell 524A JOHN'S HILL ROAD 39.021881 -84.474450 98 99 99 99 0.071 0.071 0.069 0.070 Kentucky Carter CAMP ROBERT WEBB, 1486 CAMP WEBB ROAD 38.238870 -82.988100 98 96 99 98 0.060 0.061 0.065 0.062 Kentucky Christian WILLIAMSON RESIDENCE, 10800 PILOT ROCK ROAD 36.911710 -87.323337 99 95 98 97 0.065 0.062 0.061 0.062 Kentucky Daviess 716 PLEASANT VALLEY ROAD 37.780776 -87.075307 97 98 96 97 0.064 0.065 0.068 0.065 Kentucky Edmonson 37.131790 -86.142953 98 97 84 93 0.065 0.063 0.065 0.064 Kentucky Fayette MAMMOTH CAVE NP - ALFRED COOK ROAD FAYETTE COUNTY HEALTH DEPT, 650 NEWTOWN PIKE 38.065030 -84.497610 98 95 98 97 0.065 0.071 0.065 0.067 Kentucky Kentucky Greenup Hancock 38.548136 37.938290 -82.731163 -86.897190 99 96 98 99 100 97 99 97 0.061 0.066 0.066 0.071 0.063 0.067 0.063 0.068 Kentucky Hardin 37.705612 -85.852629 90 99 98 96 0.062 0.066 0.068 0.065 Kentucky Henderson 37.871200 -87.463750 98 98 98 98 0.069 0.067 0.072 0.069 Kentucky Jefferson 38.137840 -85.576480 100 82 87 90 0.065 0.071 0.073 0.069 Kentucky Jefferson SCOTT STREET & CENTER AVENUE 2ND STREET & CAROLINE STREET AMERICAN LEGION PARK, 801 NORTH MILES STREET BASKETT FIRE DEPARTMENT, 7492 DR. HODGE ROAD 7601 BARDSTOWN RD, BATES ELEMENTARY SCH 7201 WATSON LN, WATSON LN ELEMENTARY SCH 38.060910 -85.898040 97 91 96 95 0.069 0.069 0.070 0.069 Kentucky Jefferson 2730 CANNONS LANE, BOWMAN FIELD 38.228760 -85.654520 99 100 99 99 0.070 0.076 0.076 0.074 (Page 501 of Total) 20B USCA Case #17-1172 State Name Document #1683752 Filed: 07/12/2017 Page 455 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 Site Latitude Site Longitude 2014 Percent Complete 37.891470 -84.588250 100 99 99 99 0.064 0.066 0.066 0.065 LIVINGSTON CO ROAD DEPT, 706 STATE DRIVE JACKSON PURCHASE RECC, 2901 POWELL STREET State Highway 437, West Liberty, KY 41472 KYTC MAINTENANCE FACILITY, 1601 SOUTH HWY 393 PERRY COUNTY HORSE PARK, 354 PERRY PARK ROAD 37.155392 -88.394024 99 99 98 99 0.065 0.063 0.068 0.065 37.058220 37.921400 -88.572510 -83.066200 99 90 99 98 99 100 99 96 0.065 0.064 0.063 0.064 0.063 0.066 0.063 0.064 38.400200 -85.444280 100 77 97 91 0.068 0.073 0.069 0.070 37.283290 -83.209320 99 98 93 97 0.061 0.057 0.058 0.058 37.482600 -82.535320 100 98 99 99 0.063 0.058 0.061 0.060 37.097980 -84.611520 100 98 95 98 0.063 0.062 0.063 0.062 36.708607 36.784100 -86.566284 -87.849900 100 93 84 96 99 97 94 95 0.063 0.066 0.067 0.060 0.063 0.063 0.064 0.063 County Name Street Address KYTC MAINTENANCE GARAGE, 260 WILSON DRIVE Kentucky Jessamine Kentucky Livingston Kentucky Kentucky McCracken Morgan Kentucky Oldham Kentucky Perry Kentucky Pike Kentucky Pulaski Kentucky Kentucky Simpson Trigg KYTC DISTRICT OFFICE, 109 LORAINE STREET SOMERSET GAS CO WAREHOUSE, 305 CLIFTY STREET KYTC MAINTENANCE FACILITY, 573 HARDING ROAD 5720 Old Dover Rd, Cadiz, KY 42211 Kentucky Kentucky Louisiana Louisiana Louisiana Louisiana Louisiana Louisiana Louisiana Louisiana Louisiana Louisiana Warren Washington Ascension Bossier Caddo Calcasieu Calcasieu East Baton Rouge East Baton Rouge East Baton Rouge Iberville Iberville 226 SUNSET STREET 542 Wesley-Miller Rd, Harrodsburg, KY 40330 11153 Kling Road 1425 Airport Drive HAGOOD ROAD HIGHWAY 27 AND HIGHWAY 108 2284 Paul Bellow Road EAST END OF ASTER LANE 1061-A Leesville Ave 11245 Port Hudson-Pride Rd. Zachary, La 65180 Belleview Road HIGHWAY 171, CARVILLE 37.049260 37.704600 30.233889 32.536260 32.676389 30.143333 30.227778 30.419763 30.461980 30.700921 30.220556 30.206985 -86.214870 -85.048500 -90.968333 -93.748910 -93.859722 -93.371944 -93.578333 -91.181996 -91.179220 -91.056135 -91.316111 -91.129948 98 99 97 98 98 96 99 97 99 97 98 97 86 98 99 98 99 99 99 100 100 99 98 87 99 95 98 96 98 99 95 98 97 73 99 61 94 97 98 97 98 98 98 98 99 90 98 82 0.063 0.065 0.069 0.066 0.065 0.067 0.066 0.075 0.070 0.068 0.061 0.068 0.061 0.064 0.074 0.065 0.066 0.072 0.066 0.073 0.069 0.062 0.069 0.075 0.062 0.065 0.071 0.065 0.062 0.065 0.062 0.068 0.061 0.061 0.064 0.069 0.062 0.064 0.071 0.065 0.064 0.068 0.064 0.072 0.066 0.063 0.064 0.070 Louisiana Jefferson West Temple Pl 30.043573 -90.275091 98 99 99 99 0.071 0.068 0.067 0.068 Louisiana Louisiana Louisiana Louisiana Louisiana Lafayette Lafourche Livingston Ouachita Pointe Coupee 646 Cajundome Nicholls University Farm Highway 1 Highway 16, French Settlement 5296 Southwest TED DAVIS RESIDENCE. HIGHWAY 415 30.217500 29.763889 30.312500 32.509713 30.681736 -92.051389 -90.765183 -90.812500 -92.046093 -91.366172 100 98 99 94 97 99 96 98 92 100 99 98 94 87 99 99 97 97 91 99 0.068 0.067 0.073 0.059 0.071 0.067 0.064 0.070 0.060 0.069 0.063 0.065 0.067 0.060 0.065 0.066 0.065 0.070 0.059 0.068 Louisiana St. Bernard 29.939610 -89.923880 100 100 92 97 0.071 0.063 0.065 0.066 Louisiana St. James 4101 Mistrot Dr. Meraux, LA 70075 ST. JAMES COURTHOUSE, HWY 44 @ CANAPELLA 29.994444 -90.820000 97 98 99 98 0.067 0.066 0.063 0.065 Louisiana St. John the Baptist Anthony F. Monica Street 30.058333 -90.608333 96 100 99 98 0.068 0.067 0.064 0.066 (Page 502 of Total) 21B USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 456 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 Louisiana Louisiana St. Tammany West Baton Rouge 1421 Hwy 22 W, Madison Ville, LA 70447 1005 Northwest Drive, Port Allen 30.429304 30.500643 -90.199683 -91.213556 99 100 99 99 99 99 99 99 0.074 0.066 0.067 0.066 0.064 0.066 0.068 0.066 Maine Androscoggin ROUTE 9, DURHAM 43.974622 -70.124608 99 82 99 93 0.065 0.058 0.057 0.060 Maine Maine Aroostook Aroostook 46.696431 46.604100 -68.033006 -68.413500 95 96 73 99 87 98 85 98 0.049 0.051 0.054 0.055 0.048 0.052 0.050 0.052 Maine Cumberland 8 NORTHERN ROAD, PRESQUE ISLE, ME 04769 45 Radar Rd, Ashland, ME 04732 TWO LIGHTS STATE PARK, Near the Obsevation Tower 43.561043 -70.207324 100 99 100 100 0.066 0.064 0.065 0.065 Maine Hancock TOP OF CADILLAC MOUNTAIN 44.351697 -68.226980 97 86 99 94 0.065 0.069 0.066 0.066 Maine Hancock 567 Eagle Lake Road 44.377050 -68.260900 98 100 98 99 0.062 0.065 0.060 0.062 Maine Kennebec 14 Pray Street 44.230622 -69.785000 98 99 95 97 0.057 0.063 0.059 0.059 Maine Knox PORT CLYDE, MARSHALL POINT LIGHTHOUSE 43.917955 -69.260590 99 94 97 97 0.061 0.067 0.063 0.063 Maine Penobscot SUMMIT OF RIDER BLUFF (WLBZ TRANSMITTER) 44.735978 -68.670752 99 100 99 99 0.054 0.063 0.057 0.058 Maine Maine Washington Washington PUBLIC LANDING, Jonesport 184 COUNTY ROAD 44.531907 44.963633 -67.595870 -67.060728 89 98 98 60 99 99 95 86 0.054 0.050 0.062 0.053 0.057 0.054 0.057 0.052 Maine York 43.656764 -70.629138 97 98 99 98 0.059 0.058 0.058 0.058 Maine York 34 Town Farm Road, HOLLIS Rt. 11, Shapleigh Ball Park, West Newfield Road, Shapleigh, Maine 43.588890 -70.877340 97 99 99 98 0.061 0.062 0.061 0.061 Maine York OCEAN AVE / PARSONS WAY, KENNEBUNKPORT 43.343167 -70.471034 91 78 100 90 0.066 0.067 0.068 0.067 Maryland Baltimore Padonia Elementary School, 9834 Greenside Drive 39.462029 -76.631673 91 92 95 93 0.067 0.078 0.073 0.072 Maryland Baltimore 600 Dorsey Avenue 39.310833 -76.474444 98 97 95 97 0.068 0.072 0.077 0.072 Maryland Calvert 350 Stafford Road 38.536722 -76.617194 99 95 99 98 0.070 0.067 0.068 0.068 Maryland Carroll -77.042252 100 98 99 99 0.064 0.070 0.066 0.066 Maryland Cecil 1300 W. Old Liberty Road 39.444294 Fair Hill Natural Resource Mgmt Area, 4600 Telegraph Road 39.701444 -75.860051 95 89 98 94 0.074 0.074 0.075 0.074 Maryland Charles 38.508547 -76.811864 96 98 99 98 0.070 0.068 0.073 0.070 Maryland Dorchester 14320 Oaks Road University of Maryland for Environmental and Estuarine Studies 38.587525 -76.141006 99 96 99 98 0.065 0.061 0.067 0.064 (Page 503 of Total) 22B USCA Case #17-1172 State Name Document #1683752 Filed: 07/12/2017 Page 457 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 Site Latitude Site Longitude 2014 Percent Complete 38.445000 -76.111400 95 100 90 95 0.065 0.065 0.068 0.066 Frederick County Airport ,180 E Airport Drive Piney Run, Frostburg Reservoir, Finzel Edgewood Chemical Biological Center (APG), Waehli Road 39.422760 39.705950 -77.375190 -79.012000 96 98 96 95 98 91 97 95 0.063 0.063 0.070 0.067 0.066 0.066 0.066 0.065 39.410191 -76.296946 100 99 98 99 0.067 0.074 0.077 0.072 39.563333 -76.203889 96 96 96 96 0.070 0.073 0.074 0.072 39.305021 -75.797317 99 92 96 96 0.068 0.072 0.069 0.069 39.114313 -77.106876 98 99 99 99 0.064 0.072 0.065 0.067 39.055277 -76.878333 99 95 97 97 0.065 0.072 0.069 0.068 38.811940 -76.744170 97 98 100 98 0.069 0.069 0.073 0.070 County Name Street Address Blackwater National Wildlife Refuge, Cambridge, MD 21613 Maryland Dorchester Maryland Maryland Frederick Garrett Maryland Harford Maryland Harford Maryland Kent Maryland Montgomery Maryland Prince George's Maryland Prince George's 3560 Aldino Road Millington Wildlife Management Area, Massey Maryland Line Road (Route 330) Lathrop E. Smith Environmental Education Center, 5110 Meadowside Lane Howard University's Beltsville Laboratory, 12003 Old Baltimore Pike PG County Equestrian Center, 14900 Pennsylvania Ave. Maryland Prince George's Powder Mill Rd, Laurel, MD 20708 39.028400 -76.817100 87 97 93 92 0.069 0.067 0.070 0.068 Maryland Washington MD Correctional Institution 18530 Roxbury Road 39.564178 -77.720244 97 98 98 98 0.061 0.067 0.068 0.065 Maryland Baltimore (City) Furley E.S. Recreational Center, 4633 Furley Avenue. 39.328807 -76.553075 95 77 98 90 0.060 0.072 0.067 0.066 Massachusetts Barnstable FOX BOTTOM AREA 41.975804 -70.023598 98 61 96 85 0.059 0.071 0.065 0.065 Massachusetts Bristol 659 GLOBE ST 41.685707 -71.169235 98 99 100 99 0.060 0.070 0.076 0.068 Massachusetts Bristol 30 SCHOOL ST - HASTINGS MIDDLE SCHOOL 41.645381 -70.897504 98 96 99 98 0.058 0.067 0.069 0.064 Massachusetts Dukes 1 HERRING CREEK RD, AQUINNAH(WAMPANOAG TRIBAL SITE) 41.330469 -70.785225 96 45 93 78 0.059 0.068 0.066 0.064 Massachusetts Essex 390 PARKLAND 42.474642 -70.970816 99 98 97 98 0.063 0.065 0.067 0.065 Massachusetts Essex HARBOR STREET 42.814412 -70.817783 97 96 95 96 0.064 0.065 0.065 0.064 Massachusetts Massachusetts Massachusetts Massachusetts Essex Franklin Hampden Hampshire 42.770837 42.605816 42.194380 42.298493 -71.102290 -72.596689 -72.555112 -72.334079 99 98 94 99 99 97 100 96 98 99 96 94 99 98 97 96 0.064 0.058 0.065 0.068 0.059 0.064 0.070 0.071 0.064 0.068 0.076 0.072 0.062 0.063 0.070 0.070 Massachusetts Middlesex 685 WASHINGTON STREET VETERANS FIELD ANDERSON RD AFB QUABBIN SUMMIT 11 TECHNOLOGY DRIVE, EPA NEW ENGLAND REGIONAL LABORATORY 42.626680 -71.362068 98 99 97 98 0.064 0.061 0.066 0.063 (Page 504 of Total) 23B USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 458 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 Massachusetts Norfolk 695 HILLSIDE ST Blue Hill Observatory 42.211774 -71.113970 94 94 98 95 0.065 0.067 0.070 0.067 Massachusetts Plymouth 170 Clinton Street(Buckley) 42.065106 -71.012129 99 96 98 98 0.060 0.065 0.067 0.064 Massachusetts Suffolk HARRISON AVE 42.329500 -71.082600 100 99 99 99 0.054 0.056 0.058 0.056 Massachusetts Worcester 375 AIRPORT DRIVE 42.274319 -71.875511 96 99 99 98 0.065 0.063 0.066 0.064 Massachusetts Worcester 366 E HARTFORD DR 42.099699 -71.619399 98 91 100 96 0.064 0.059 0.070 0.064 Michigan Michigan Allegan Benzie 966 W 32ND 1060 WEST ST., BENZONIA TWP. 42.767786 44.616943 -86.148577 -86.109408 97 95 99 99 97 92 98 95 0.077 0.069 0.072 0.067 0.076 0.072 0.075 0.069 Michigan Berrien 42.197790 -86.309694 99 99 98 99 0.073 0.072 0.078 0.074 Michigan Cass PAW PAW WWTP, 4689 DEFIELD RD. ROSS BEATTY HIGH SCHOOL, 22721 DIAMOND COVE ST. 41.895570 -86.001629 89 98 99 95 0.066 0.068 0.077 0.070 Michigan Chippewa LK SUPERIOR STATE UNIV,650 W EASTERDAY A 46.493611 -84.364167 93 92 92 92 0.056 0.059 0.062 0.059 Michigan Michigan Clinton Genesee 42.798339 43.047224 -84.393795 -83.670159 98 99 99 99 98 98 98 99 0.066 0.068 0.064 0.066 0.073 0.072 0.067 0.068 Michigan Genesee 8562 E STOLL RD WHALEY PARK, 3610 IOWA LAKEVILLE MIDDLE SCHOOL, G11107 WASHBURN RD 43.168336 -83.461541 99 98 99 99 0.068 0.067 0.073 0.069 Michigan Michigan Huron Ingham 1172 S.M25,SAND BEACH TWP. 220 N PENNSYLVANIA 43.836388 42.738618 -82.642900 -84.534633 90 99 99 99 99 93 96 97 0.066 0.065 0.067 0.064 0.072 0.073 0.068 0.067 Michigan Kalamazoo FAIRGROUNDS, 1400 OLMSTEAD RD 42.278067 -85.541890 99 96 98 98 0.067 0.067 0.074 0.069 Michigan Kent 1179 MONROE NW 42.984173 -85.671339 97 100 100 99 0.066 0.067 0.075 0.069 Michigan Kent 10300 14 MILE RD NE #B 43.176672 -85.416608 99 99 98 99 0.066 0.065 0.072 0.067 Michigan Michigan Lenawee Macomb 41.995568 42.731394 -83.946559 -82.793463 93 98 99 99 98 99 97 99 0.068 0.071 0.065 0.072 0.069 0.075 0.067 0.072 Michigan Michigan Macomb Manistee 6792 RAISEN CENTER HIGHWAY 57700 GRATIOT WARREN FIRE STATION 29900 HOOVER AT COMMON 3031 DOMRES RD. 42.513340 44.307000 -83.005971 -86.242649 98 97 97 99 99 98 98 98 0.068 0.068 0.064 0.067 0.071 0.070 0.067 0.068 Michigan Mason 525 W US10 43.953334 -86.294415 99 99 98 99 0.070 0.066 0.074 0.070 Michigan Missaukee 1769 S JEFFS RD 44.310555 -84.891865 100 98 99 99 0.063 0.064 0.074 0.067 (Page 505 of Total) 24B USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 459 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 Michigan Michigan Muskegon Oakland 1340 GREEN CREEK ROAD 13701 OAK PARK BLVD. 43.278061 42.463063 -86.311083 -83.183199 99 97 96 94 97 99 97 97 0.075 0.067 0.074 0.066 0.076 0.075 0.075 0.069 Michigan Michigan Ottawa St. Clair 6981 28TH AVE. GEORGETOWN TWP. 2525 DOVE RD 42.894451 42.953336 -85.852734 -82.456229 96 99 87 98 89 99 91 99 0.071 0.071 0.065 0.075 0.074 0.073 0.070 0.073 Michigan Michigan Schoolcraft Tuscola SENEY NAT'L WILDLIFE REFUGE, HCR2, BOX 1 1821 E. Dickerson Rd, Unionville, MI 48767 46.288877 43.613800 -85.950227 -83.359100 98 97 99 95 99 98 99 97 0.067 0.063 0.070 0.064 0.075 0.071 0.070 0.066 Michigan Michigan Michigan Michigan Michigan Washtenaw Washtenaw Wayne Wayne Wexford 555 TOWNER ST 10070 Strawberry Lake Rd, Dexter, MI 48130 14700 GODDARD 11600 EAST SEVEN MILE ROAD 10637 S 9 Rd, Cadillac, MI 49601 42.240565 42.416500 42.228620 42.430840 44.180900 -83.599602 -83.902000 -83.208200 -83.000138 -85.739000 98 89 97 96 97 99 92 94 97 99 98 92 99 95 95 98 91 97 96 97 0.070 0.067 0.064 0.073 0.066 0.064 0.064 0.064 0.070 0.064 0.069 0.074 0.070 0.074 0.071 0.067 0.068 0.066 0.072 0.067 Minnesota Anoka 2660 Fawn Rd. 45.401840 -93.203060 100 100 99 100 0.062 0.058 0.061 0.060 Minnesota Minnesota Minnesota Minnesota Anoka Becker Crow Wing Goodhue 9399 Lima St 26624 NORTH TOWER ROAD 16384 AIRPORT RD 1235 HIGHWAY 19 45.137680 46.851811 46.396740 44.473754 -93.207615 -95.846272 -94.130300 -93.012611 100 100 100 100 98 99 99 99 99 99 98 100 99 99 99 100 0.064 0.061 0.057 0.063 0.064 0.062 0.060 0.060 0.061 0.059 0.060 0.061 0.063 0.060 0.059 0.061 Minnesota Minnesota Minnesota Hennepin Lake Lyon 1444 E 18th St Fernberg Road WEST HIGHWAY 19 44.965242 47.948622 44.443800 -93.254759 -91.495574 -95.817890 99 97 100 99 97 98 100 94 100 99 96 99 0.060 0.056 0.062 0.053 0.056 0.067 0.056 0.058 0.057 0.056 0.056 0.062 Minnesota Minnesota Mille Lacs Olmsted 16687 Shaw-Bosh-Kung Drive 1801 9th Ave. SE 46.205300 43.996908 -93.759450 -92.450366 100 100 100 100 97 98 99 99 0.060 0.062 0.059 0.059 0.061 0.062 0.060 0.061 Minnesota Minnesota Saint Louis Saint Louis VOYAGEURS NATIONAL PARK 1202 EAST UNIVERSITY CIRCLE 48.412520 46.818260 -92.829225 -92.089360 100 95 99 100 79 96 93 97 0.057 0.052 0.056 0.054 0.052 0.055 0.055 0.053 Minnesota Minnesota Scott Stearns 917 DAKOTA ST. 1321 University Dr. 44.791437 45.549839 -93.512534 -94.133450 99 100 98 95 99 100 99 98 0.061 0.062 0.060 0.060 0.061 0.058 0.060 0.060 Minnesota Washington St. Croix Trail N 45.168004 -92.765136 98 97 99 98 0.061 0.058 0.060 0.059 Minnesota Mississippi Mississippi Mississippi Mississippi Wright Bolivar DeSoto Hancock Harrison 101 Central Ave. W. 213 N. BAYOU AVE. 5 EAST SOUTH ST. (HERNANDO) 400 Baltic St 47 Maple Street 45.209160 33.746056 34.821660 30.300833 30.390369 -93.669210 -90.723028 -89.987830 -89.395916 -89.049778 100 97 100 99 89 96 99 99 96 98 98 98 88 94 98 98 98 96 96 95 0.064 0.060 0.067 0.069 0.073 0.059 0.063 0.061 0.061 0.067 0.061 0.064 0.066 0.061 0.063 0.061 0.062 0.064 0.063 0.067 (Page 506 of Total) 25B USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 460 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 Mississippi Mississippi Mississippi Hinds Jackson Lauderdale 232 East Woodrow Wilson Drive Hospital Road at Co. Health Dept. Hwy 19 and 53rd Ave 32.329111 30.378287 32.364565 -90.182722 -88.533930 -88.731491 97 97 98 93 98 98 90 98 86 93 98 94 0.064 0.075 0.058 0.061 0.065 0.056 0.060 0.062 0.058 0.061 0.067 0.057 Mississippi Lee 34.264917 -88.766222 99 96 97 97 0.059 0.058 0.061 0.059 Mississippi Yalobusha West Jackson at Tupelo Airport Jamie L. Whitten Plant Materials Center, Coffeeville, MS 38922 34.002600 -89.799000 88 87 99 91 0.060 0.056 0.057 0.057 Missouri Andrew 39.954400 -94.849000 99 99 100 99 0.064 0.064 0.062 0.063 Missouri Boone 39.078070 -92.316260 100 99 100 100 0.064 0.063 0.065 0.064 Missouri Callaway 38.706080 -92.093080 99 100 100 100 0.064 0.065 0.064 0.064 Missouri Cass 38.759760 -94.579970 100 100 99 100 0.065 0.065 0.061 0.063 Missouri Cedar 37.690000 -94.035000 99 99 99 99 0.065 0.060 0.060 0.061 Missouri Clay 39.407452 -94.265373 99 100 100 100 0.067 0.064 0.066 0.065 Missouri Clay 39.303090 -94.376623 100 99 98 99 0.065 0.062 0.066 0.064 Missouri Clay SAVANAH: 11796 Highway 71, Savanah, MO 64485 FINGER LAKES: 1505 East Peaboy Road, Columbia, MO 65202 NEW BLOOMFIELD: 2625 Medow Lane, New Bloomfield, MO, 65063 RICHARDS GEBAUR - SOUTH: 1802 E 203rd Street, Belton, MO 64012 EL DORADO SPRINGS: Highway 97 & Barnes Road, El Dorado Springs, 64744 WATKINS MILL STATE PARK: Watkins Mill Road, Lawson, MO 64062 LIBERTY: Highway & County Home Road, Liberty, 64068 ROCKY CREEK: 13131 Highway 169 NE, Smithville, MO 64089 39.331913 -94.580841 100 100 99 100 0.066 0.068 0.069 0.067 Missouri Clinton 39.530600 -94.556000 99 100 99 99 0.064 0.068 0.069 0.067 Missouri Greene 37.256136 -93.299886 100 96 93 96 0.060 0.061 0.058 0.059 Missouri Missouri Greene Jasper 37.319510 37.238500 -93.204635 -94.424680 99 100 100 98 99 100 99 99 0.060 0.065 0.061 0.061 0.059 0.059 0.060 0.061 Missouri Jefferson TRIMBLE: 7536 SW O Highway, Trimble, MO 64492 HILLCREST HIGH SCHOOL: 3319 N Grant, Springfield, MO 65803 FELLOWS LAKE: 4208 E Farm Road 66, Springfield, MO 65803 ALBA: 20400 Millwood Road, Alba, MO64755 ARNOLD WEST: 1709 Lonedell Drive, Arnold, MO 63010 38.448633 -90.398540 99 100 99 99 0.072 0.069 0.070 0.070 Missouri Lincoln 39.044700 -90.864700 100 99 99 99 0.067 0.065 0.065 0.065 Missouri Missouri Monroe Perry 39.474976 37.702640 -91.788991 -89.698640 100 100 100 99 100 100 100 100 0.060 0.067 0.058 0.067 0.059 0.069 0.059 0.067 Missouri Saint Charles 38.872546 -90.226488 100 90 99 96 0.072 0.070 0.075 0.072 Missouri Saint Charles 38.899400 -90.449170 100 100 100 100 0.072 0.066 0.076 0.071 Missouri Sainte Genevieve FOLEY: #7 Wild Horse, Foley, MO 63347 MARK TWAIN STATE PARK: 20057 State Park Office Road, Stoutville, MO 65283 FARRAR: County Road 342, Farrar, MO 63746 WEST ALTON: General Electric Store, Highway 94, WestT Alton, MO 63386 ORCHARD FARM: 2165 Highway V, St. Charles, MO 63301 BONNE TERRE: 15797 Highway D, Bonne Terre, MO 63628 37.900840 -90.423880 100 100 98 99 0.069 0.063 0.067 0.066 (Page 507 of Total) 26B USCA Case #17-1172 State Name Document #1683752 Filed: 07/12/2017 Page 461 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 Site Latitude Site Longitude 2014 Percent Complete PACIFIC: 18701 Old Highway 66, Pacific, MO 63039 MARYLAND HEIGHTS: 13044 Marine Avenue, Maryland Heights, MO 63146 38.490200 -90.705200 100 100 99 100 0.065 0.065 0.067 0.065 38.710900 -90.475900 99 100 99 99 0.072 0.069 0.073 0.071 BRANSON: 251 S.W. Outer Rd, Branson, MO 65616 BLAIR STREET: 3247 Blair Street, St. Louis, MO 63107 303 East Aztec Drive Lewistown MT 59457 36.707727 -93.222000 100 100 99 100 0.058 0.059 0.056 0.057 38.656498 47.048537 -90.198646 -109.455315 99 91 99 92 100 97 99 93 0.066 0.056 0.063 0.056 0.068 0.055 0.065 0.055 48.510300 46.850500 46.842181 48.317507 45.440295 47.803392 45.366151 -113.996810 -111.987164 -114.021499 -107.862471 -105.370283 -104.485552 -106.489820 91 100 82 89 73 95 100 98 92 99 98 98 94 82 93 100 98 99 96 92 98 94 97 93 95 89 94 93 0.052 0.058 0.053 0.052 0.053 0.051 0.055 0.057 0.058 0.055 0.061 0.057 0.058 0.056 0.050 0.055 0.051 0.053 0.055 0.057 0.057 0.053 0.057 0.053 0.055 0.055 0.055 0.056 41.247486 -95.973142 99 100 93 97 0.063 0.062 0.062 0.062 County Name Street Address Missouri Saint Louis Missouri Saint Louis Missouri Taney Missouri Montana St. Louis City Fergus Montana Montana Montana Montana Montana Montana Montana Flathead Lewis and Clark Missoula Phillips Powder River Richland Rosebud Nebraska Douglas GLACIER NATIONAL PARK I-15 Exit 209, then Sperry Dr. BOYD PARK, 3100 WASHBURN Rd. 2309 Short Oil Road, Malta, MT 59538 Big Powder River Road East Corner Cnty Roads 335 and 131 SR 566, 3 Miles N of Birney DOUGLAS COUNTY HOSP 42ND & WOOLWORTH Nebraska Nebraska Nebraska Douglas Knox Lancaster 2411 O ST. State Spur 54D, Niobrara, NE 68760 FIRST & MAPLE , DAVEY 41.207958 42.829200 40.984722 -95.945897 -97.854000 -96.677222 98 97 98 96 95 97 97 99 97 97 97 97 0.059 0.063 0.061 0.055 0.063 0.061 0.063 0.064 0.058 0.059 0.063 0.060 Nevada Churchill 280 SOUTH RUSSELL STREET 39.472471 -118.783624 98 94 95 96 0.065 0.068 0.067 0.066 Nevada Clark 12101 Hwy 91, Nevada Las Vegas, NV 89165 36.391007 -114.907406 52 74 72 66 0.076 0.072 0.068 0.072 Nevada Clark 465 E. OLD MILL ROAD, MESQUITE, NV 36.807913 -114.060879 50 73 72 65 0.065 0.065 0.058 0.062 Nevada Clark 4525 NEW FOREST DRIVE 36.106372 -115.253352 81 99 98 93 0.077 0.073 0.069 0.073 Nevada Clark 7701 DUCHARME AVE 36.169751 -115.263025 81 91 99 90 0.074 0.068 0.070 0.070 Nevada Clark 333 PAVILION CENTER DRIVE 36.173416 -115.332714 100 99 99 99 0.077 0.072 0.069 0.072 Nevada Clark 6651 W. AZURE AVE 36.270583 -115.238256 97 99 96 97 0.079 0.071 0.073 0.074 Nevada Clark 4250 Karen Ave 36.141895 -115.078725 99 99 98 99 0.073 0.069 0.067 0.069 Nevada Clark 1005 INDUSTRIAL ROAD 35.978125 -114.846298 99 92 98 96 0.073 0.068 0.062 0.067 Nevada Clark 1965 State Hwy 161, Jean, NV 35.785671 -115.357048 95 99 98 97 0.074 0.071 0.066 0.070 Nevada Clark 1301B EAST TONOPAH 36.191260 -115.122930 98 97 98 98 0.075 0.073 0.070 0.072 (Page 508 of Total) 27B USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 462 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 Nevada Clark 668 Gretta Ln, Indian Springs 36.569444 -115.676667 53 75 75 68 0.070 0.070 0.068 0.069 Nevada Nevada Nevada Nevada Nevada Lyon Washoe Washoe Washoe Washoe 320 HARDIE LANE 301 A STATE STREET, RENO, NV 89502 4110 DE LUCCI LANE, RENO NV 89502 684A STATE ROUTE 341, RENO NV 89521 750 4TH ST, SPARKS, NV 89431 39.602787 39.525083 39.469219 39.399837 39.540917 -119.247741 -119.807717 -119.775354 -119.739606 -119.746761 99 95 100 99 99 100 94 99 99 99 95 95 98 99 99 98 95 99 99 99 0.067 0.071 0.068 0.067 0.069 0.071 0.073 0.070 0.069 0.070 0.068 0.069 0.068 0.065 0.069 0.068 0.071 0.068 0.067 0.069 Nevada Washoe 855 ALDER DRIVE, INCLINE VILLAGE, NV 89451 39.250409 -119.956738 100 99 100 100 0.063 0.062 0.063 0.062 Nevada Nevada Washoe White Pine -119.840025 -114.215930 100 93 99 97 100 97 100 96 0.067 0.064 0.072 0.066 0.069 0.063 0.069 0.064 Nevada Carson City 325 PATRICIAN DR, LEMMON VALLEY, NV 89506 39.645264 GREAT BASIN NATIONAL PARK 39.005120 2601 SOUTH CARSON ST (OLD NATIONAL GUARD ARMORY) 39.144700 -119.766100 100 100 99 100 0.068 0.068 0.066 0.067 New Hampshire New Hampshire New Hampshire Belknap Cheshire Coos GREEN STREET, LACONIA WATER STREET MT. WASHINGTON 43.566111 42.930472 44.270167 -71.496361 -72.272389 -71.303750 99 100 99 99 99 98 99 100 99 99 100 99 0.061 0.060 0.065 0.055 0.059 0.071 0.060 0.066 0.066 0.058 0.061 0.067 New Hampshire Coos CAMP DODGE, ROUTE 16, GREEN'S GRANT 44.308167 -71.217694 97 99 95 97 0.055 0.057 0.059 0.057 New Hampshire Grafton 43.629611 -72.309583 99 99 100 99 0.062 0.054 0.055 0.057 New Hampshire Grafton LEBANON AIRPORT Hubbard Brook Experimental Forest, North Woodstock, NH 03262 43.945000 -71.700800 99 98 100 99 0.058 0.052 0.054 0.054 New Hampshire Hillsborough GILSON ROAD 42.718664 -71.522427 99 98 99 99 0.064 0.061 0.064 0.063 New Hampshire Hillsborough PACK MONADNOCK SUMMIT 42.861750 -71.878389 99 100 100 100 0.069 0.066 0.069 0.068 New Hampshire Merrimack HAZEN DRIVE 43.218500 -71.514500 98 100 100 99 0.061 0.062 0.062 0.061 New Hampshire Rockingham PORTSMOUTH, PEIRCE ISLAND 43.075333 -70.748000 99 100 100 100 0.068 0.065 0.062 0.065 New Hampshire Rockingham SEACOAST SCIENCE CENTER 43.045278 -70.713806 99 97 99 98 0.070 0.065 0.067 0.067 New Hampshire Rockingham 42.862536 -71.380172 99 100 98 99 0.067 0.062 0.067 0.065 New Jersey Atlantic 150 Pillsbury Rd Edwin B. Forsythe National Wildlife Refuge Visitor Center, Great Creek Road 39.464872 -74.448736 99 96 99 98 0.061 0.068 0.063 0.064 New Jersey Bergen Overpeck Park, 40 Fort Lee Road 40.870436 -73.991994 97 98 99 98 0.073 0.076 0.072 0.073 New Jersey Camden 266 Spruce Street 39.934446 -75.125291 100 100 100 100 0.068 0.079 0.076 0.074 (Page 509 of Total) 28B USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 463 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 New Jersey Camden Ancora State Hospital, 202 Spring Garden Road 39.684250 -74.861491 100 97 99 99 0.068 0.072 0.064 0.068 New Jersey Cumberland Lincoln Avenue and Route 55, Northeast of Millville 39.422273 -75.025204 100 99 100 100 0.067 0.068 0.068 0.067 New Jersey Essex 40.720989 -74.192892 99 99 100 99 0.070 0.072 0.068 0.070 New Jersey Gloucester 39.800339 -75.212119 84 96 95 92 0.070 0.076 0.074 0.073 New Jersey Hudson 40.670250 -74.126081 99 100 100 100 0.072 0.077 0.067 0.072 New Jersey Hunterdon 360 Clinton Avenue Clarksboro Shady Rest Home, Shady Lane and County House Road Veterans Park on Newark Bay, 25th Street near Park Road Raritan Township Municipal Utilities Authority, 365 Old York Road 40.515262 -74.806671 100 100 100 100 0.065 0.073 0.073 0.070 New Jersey Mercer Athletic Fields, Route 206 South 40.283092 -74.742644 100 99 100 100 0.071 0.073 0.071 0.071 New Jersey Mercer Washington Crossing State Park, Titusville, NJ 08560 40.312500 -74.872900 100 99 97 99 0.071 0.075 0.074 0.073 New Jersey Middlesex Horticultural Farm #3, off Ryder's Lane 40.462182 -74.429439 97 68 95 87 0.071 0.077 0.074 0.074 New Jersey Monmouth 40.277647 -74.005100 98 98 100 99 0.064 0.077 0.068 0.069 New Jersey Morris Edison Science Building, 400 Cedar Avenue Building #1, Department of Public Works (DPW) off Route 513 40.787628 -74.676301 97 99 95 97 0.068 0.070 0.068 0.068 New Jersey Ocean 40.064830 -74.444050 100 100 89 96 0.072 0.075 0.071 0.072 New Jersey Passaic Colliers Mills Wildlife Management Area Ramapo Mountain State Forest, Access Road, off Skyline Drive 41.058617 -74.255544 98 96 96 97 0.067 0.071 0.068 0.068 New Jersey Warren Columbia Wildlife Management Area, Delaware Road 40.924580 -75.067815 99 100 100 100 0.060 0.066 0.065 0.063 New Mexico Bernalillo 4700A SAN MATEO NE 35.134300 -106.585200 98 97 97 97 0.064 0.065 0.067 0.065 New Mexico Bernalillo 201 PROSPERITY SE 35.017080 -106.657390 98 98 95 97 0.064 0.068 0.063 0.065 New Mexico Bernalillo 8901 LOWELL NE 35.185200 -106.508150 97 98 94 96 0.061 0.067 0.064 0.064 New Mexico Dona Ana ST LUKES EPISCOPAL CH RT 1 (LA UNION) 31.930556 -106.630556 97 98 99 98 0.065 0.070 0.063 0.066 New Mexico Dona Ana 680 MCCOMBS, CHAPARRAL, NM 32.041111 -106.409167 92 98 99 96 0.067 0.065 0.067 0.066 New Mexico Dona Ana 5935A VALLE VISTA, SUNLAND PARK, NM 31.796111 -106.583889 91 98 99 96 0.072 0.074 0.070 0.072 (Page 510 of Total) 29B USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 464 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 New Mexico Dona Ana 104-2 SANTA TERESA INTERNATIONAL BLVD,NM 31.787778 -106.682778 90 97 99 95 0.066 0.070 0.069 0.068 New Mexico Dona Ana 750 N.SOLANO DRIVE, LAS CRUCES, NM 32.317500 -106.767778 100 99 97 99 0.066 0.066 0.064 0.065 New Mexico Eddy HOLLAND ST,SE OF WATER TANK,CARLSBAD,NM 32.380000 -104.262222 92 96 98 95 0.072 0.067 0.063 0.067 New Mexico Lea 2320 N. JEFFERSON ST, HOBBS, NEW MEXICO 32.726656 -103.122917 95 98 97 97 0.068 0.067 0.065 0.066 New Mexico Rio Arriba 21 New Mexico 96, Coyote, NM, 87012 36.187742 -106.698369 97 98 98 98 0.065 0.064 0.063 0.064 New Mexico Sandoval HIGHWAY DEPT. YARD NEAR BERNALILLO 35.299444 -106.548333 90 97 98 95 0.062 0.066 0.064 0.064 New Mexico New Mexico San Juan San Juan 162 HWAY 544, BLOOMFIELD NM 87413 423 HWAY 539, NAVAJO DAM, NM 87419 36.742222 36.809730 -107.976944 -107.651580 99 92 99 99 99 94 99 95 0.062 0.063 0.061 0.068 0.065 0.067 0.062 0.066 New Mexico San Juan USBR SHIPROCK SUBSTATION (FARMINGTON) 36.796667 -108.472500 97 99 100 99 0.063 0.061 0.062 0.062 New Mexico Santa Fe 2001 Aviation Drive, Santa Fe, New Mexico 87507 35.619750 -106.079680 99 99 99 99 0.064 0.062 0.064 0.063 New Mexico Valencia 34.814700 -106.739600 97 97 98 97 0.064 0.064 0.065 0.064 New York Albany 1000 W. MAIN ST, LOS LUNAS, NM 87031 LOUDONVILLE RESERVOIR 300 ALBANY SHAKER RD 42.680750 -73.757330 93 99 98 97 0.061 0.063 0.068 0.064 New York Bronx 40.816180 -73.902000 97 99 99 98 0.071 0.063 0.069 0.067 New York Bronx IS 52 681 KELLY ST 200TH STREET AND SOUTHERN BOULDVARD Pfizer Lab 40.867900 -73.878090 100 100 100 100 0.070 0.072 0.070 0.070 New York Chautauqua 42.499630 -79.318810 95 97 100 97 0.066 0.071 0.069 0.068 New York Dutchess STP, Wright Park Drive, DUNKIRK Forest Road, VILLAGE OF MILLBROOK, Inst of Ecosystem Studies 41.785550 -73.741360 97 97 96 97 0.068 0.067 0.071 0.068 New York Erie 42.993280 -78.771530 95 100 96 97 0.063 0.071 0.074 0.069 New York Essex AUDUBON GOLF COURSE, 450 MAPLE ROAD Wilmington, SUMMIT, WHITEFACE MTN, WEATHER STATION 44.366080 -73.903120 90 98 98 95 0.059 0.060 0.067 0.062 New York Essex Wilmington, BASE WHITEFACE MTN, ASRC, SUNY 44.393080 -73.858900 95 90 93 93 0.060 0.067 0.068 0.065 (Page 511 of Total) 30B USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 465 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 New York New York New York Essex Franklin Hamilton Huntington Wildlife Forest, Newcomb, NY 12852 55 Library Road, HOGANSBURG, NY 13655 PISECO LAKE AIRPORT 43.973100 44.980577 43.449570 -74.223200 -74.695005 -74.516250 94 94 97 95 93 98 95 86 95 95 91 97 0.059 0.054 0.058 0.059 0.071 0.062 0.056 0.047 0.061 0.058 0.057 0.060 New York New York New York Herkimer Jefferson Monroe 278 Bisby Road, NICKS LAKE CAMPGROUND VAADI ROAD, PERCH RIVER 2 YARMOUTH ROAD, RG&E Substation 43.685780 44.087470 43.146180 -74.985380 -75.973160 -77.548170 98 99 98 99 98 98 96 88 97 98 95 98 0.057 0.059 0.058 0.061 0.065 0.065 0.071 0.067 0.067 0.063 0.063 0.063 New York New York 160 CONVENT AVENUE 40.819760 -73.948250 97 100 100 99 0.065 0.071 0.071 0.069 New York New York Niagara Onondaga MIDDLEPORT STP, 3825 NORTH HARTLAND RD 5895 ENTERPRISE PARKWAY, 43.223860 43.052350 -78.478880 -76.059210 83 96 98 96 97 100 93 97 0.061 0.063 0.067 0.063 0.070 0.067 0.066 0.064 New York New York Orange Oswego 1175 ROUTE 17K, MONTGOMERY Valley Central HS 820 COUNTY ROUTE 8 41.523750 43.284280 -74.215340 -76.463240 99 98 99 99 96 85 98 94 0.062 0.058 0.072 0.063 0.064 0.061 0.066 0.060 New York Putnam NYSDEC FIELD HQTRS GYPSY TRAIL ROAD 41.455890 -73.709770 100 99 98 99 0.066 0.069 0.071 0.068 New York Queens 40.736140 -73.821530 92 99 95 95 0.063 0.073 0.071 0.069 New York Richmond Queens College 65-30 Kissena Blvd Parking Lot#6 SUSAN WAGNER HS, 1200 MANOR RD, near Brielle Ave 40.596640 -74.125250 96 100 98 98 0.072 0.079 0.077 0.076 New York Rockland 2 South Mountain Road 41.182080 -74.028190 100 100 98 99 0.068 0.077 0.073 0.072 New York Saratoga SARATOGA NATIONAL HISTORICAL PARK 43.012090 -73.648900 100 100 98 99 0.061 0.061 0.067 0.063 New York Steuben 42.091420 -77.209780 91 85 94 90 0.058 0.059 0.062 0.059 New York Suffolk 8301 ACKERSON ROAD, Pinnacle State Park EAST FARMINGDALE WATER DIST., 72 GAZZA BLVD. 40.745290 -73.419190 99 98 94 97 0.066 0.078 0.073 0.072 New York Suffolk 3059 SOUND AVENUE, RIVERHEAD 40.960780 -72.712380 95 99 95 96 0.064 0.076 0.078 0.072 New York Suffolk 40.827990 -73.057540 89 78 98 88 0.062 0.063 0.073 0.066 New York Tompkins 42.400600 -76.653800 95 96 98 96 0.059 0.064 0.066 0.063 New York Wayne 43.230860 -77.171360 90 98 98 95 0.064 0.061 0.067 0.064 New York North Carolina North Carolina North Carolina North Carolina North Carolina North Carolina Westchester Alexander Avery Avery Buncombe Caldwell Carteret 57 DIVISION STREET Connecticut Hill Wildlife Management Area, Newfield, NY 14867 4440 Ridge Road, WAYNE County Occupational CENTER, WILLIAMSON WHITE PLAINS PUMP STATION, 240 ORCHARD STREET 700 Liledoun Road 7510 BLUE RIDGE PARKWAY SPUR Pisgah National Forest, Newland, NC 28657 ROUTE 191 SOUTH BREVARD RD 219 NUWAY CIRCLE Open Grounds Farm, Beaufort, NC 28516 41.051920 35.913900 35.972347 36.105800 35.500102 35.935833 34.884800 -73.763660 -81.191000 -81.933072 -82.045400 -82.599860 -81.530278 -76.620300 100 99 99 94 100 98 93 100 97 97 96 99 96 82 100 99 95 90 99 100 91 100 98 97 93 99 98 89 0.074 0.064 0.061 0.062 0.064 0.061 0.062 0.073 0.065 0.062 0.062 0.065 0.065 0.058 0.075 0.066 0.063 0.069 0.062 0.066 0.060 0.074 0.065 0.062 0.064 0.063 0.064 0.060 (Page 512 of Total) 31B USCA Case #17-1172 Document #1683752 Filed: 07/12/2017 Page 466 of 598 Site Longitude -79.467417 2014 Percent Complete 100 2015 Percent Complete 98 2016 Percent Complete 97 2014-2016 Average Percent Complete 98 2014 4th 2015 4th 2016 4th Highest Highest Highest Design Daily Daily Daily Value Max Max Max 2014Value Value Value 2016 0.067 0.060 0.064 0.063 State Name North Carolina County Name Caswell Street Address 7074 CHERRY GROVE RD, REIDSVILLE Site Latitude 36.307033 North Carolina North Carolina Cumberland Durham 7112 Covington Lane 801 STADIUM DRIVE 35.158686 36.032944 -78.728035 -78.905417 99 100 97 96 99 98 98 98 0.061 0.062 0.060 0.061 0.064 0.063 0.061 0.062 North Carolina Edgecombe 7589 NC Hwy 33-NW 35.988333 -77.582778 77 95 92 88 0.062 0.061 0.064 0.062 North Carolina Forsyth 1300 BLK. HATTIE AVENUE 36.110556 -80.226667 100 99 99 99 0.065 0.070 0.066 0.067 North Carolina Forsyth FRATERNITY CHURCH ROAD 36.026000 -80.342000 99 99 98 99 0.067 0.068 0.070 0.068 North Carolina North Carolina North Carolina Forsyth Graham Granville 3656 PIEDMONT MEMORIAL DRIVE FOREST ROAD 423 SPUR 800 Central Avenue 36.050833 35.257930 36.141111 -80.143889 -83.795620 -78.768056 99 99 100 98 94 100 98 100 100 98 98 100 0.067 0.063 0.065 0.065 0.065 0.063 0.069 0.066 0.065 0.067 0.064 0.064 North Carolina North Carolina Guilford Haywood 205 WILOUGHBY BLVD 2236 ASHEVILLE ROAD 36.109167 35.507160 -79.801111 -82.963370 100 95 99 95 99 100 99 97 0.065 0.060 0.064 0.064 0.068 0.062 0.065 0.062 North Carolina North Carolina North Carolina North Carolina Haywood Haywood Johnston Lee TOWER BLUE RIDGE PKWY MILE MARKER 410 6905 Purchase Knob Road 1338 JACK ROAD 4110 Blackstone Drive 35.379167 35.587144 35.590833 35.432500 -82.792500 -83.074156 -78.461944 -79.288700 91 99 99 99 93 99 99 100 99 91 99 98 94 96 99 99 0.067 0.064 0.064 0.064 0.065 0.066 0.065 0.060 0.067 0.065 0.066 0.064 0.066 0.065 0.065 0.062 North Carolina Lenoir HIGHWAY 70 EAST AND HIGHWAY 58 SOUTH 35.231459 -77.568792 100 97 90 96 0.065 0.062 0.063 0.063 North Carolina Lincoln -81.276750 99 97 98 98 0.064 0.068 0.069 0.067 North Carolina North Carolina Macon Martin 1487 RIVERVIEW ROAD 35.438556 USDA Southern Research Station, Coweeta Hydrologic Laboratory, Otto, NC 28763 35.060800 1210 Hayes Street 35.810660 -83.430600 -76.906249 95 100 94 96 94 92 94 96 0.063 0.061 0.062 0.059 0.061 0.061 0.062 0.060 North Carolina North Carolina North Carolina North Carolina North Carolina Mecklenburg Montgomery New Hanover Person Pitt 1130 EASTWAY DRIVE 136 Perry Dr, Candor, NC 27229 6028 HOLLY SHELTER RD SR49 403 Government Circle 35.240100 35.263200 34.364167 36.306965 35.638610 -80.785683 -79.836500 -77.838611 -79.091970 -77.358050 100 100 99 100 95 100 96 97 100 97 99 87 97 100 92 100 94 98 100 95 0.065 0.062 0.063 0.065 0.063 0.073 0.059 0.057 0.061 0.060 0.070 0.062 0.060 0.063 0.065 0.069 0.061 0.060 0.063 0.062 North Carolina Rockingham 6371 NC 65 @ BETHANY SCHOOL 36.308889 -79.859167 100 100 99 100 0.065 0.066 0.067 0.066 North Carolina North Carolina North Carolina Rowan Swain Swain 301 WEST ST & GOLD HILL AVENUE 30 Recreation Park Drive 1501 Acquoni Rd. 35.551868 35.434767 35.498711 -80.395039 -83.442133 -83.310242 100 100 95 98 100 92 100 97 98 99 99 95 0.064 0.058 0.060 0.066 0.060 0.063 0.066 0.064 0.061 0.065 0.060 0.061 North Carolina North Carolina North Carolina North Dakota North Dakota Union Wake Yancey Billings Burke 701 CHARLES STREET 3801 SPRING FOREST RD. 2388 State Highway 128 13881 I94 EAST 8315 HIGHWAY 8, KENMARE 34.973889 35.856111 35.765413 46.894300 48.641930 -80.540833 -78.574167 -82.264944 -103.378530 -102.401800 100 100 92 99 97 97 97 90 99 97 98 97 95 99 99 98 98 92 99 98 0.067 0.063 0.061 0.055 0.058 0.067 0.065 0.064 0.064 0.065 0.070 0.069 0.070 0.056 0.055 0.068 0.065 0.065 0.058 0.059 (Page 513 of Total) 32B USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 467 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 North Dakota North Dakota North Dakota North Dakota North Dakota North Dakota North Dakota Ohio Ohio Burleigh Cass Dunn McKenzie Mercer Oliver Williams Allen Ashtabula 1810 N 16TH STREET 4266 40TH AVE NORTH 9610 SEVENTH STREET SW 229 SERVICE RD., WATFORD CITY 6024 HIGHWAY 200 1575 HIGHWAY 31 10th Street West 2850 BIBLE ROAD 770 LAKE RD. 46.825425 46.933754 47.313200 47.581200 47.298611 47.185833 48.152780 40.770944 41.959695 -100.768210 -96.855350 -102.527300 -103.299500 -101.766944 -101.428056 -103.639510 -84.053900 -80.572808 99 92 98 95 98 89 97 99 99 95 78 100 96 99 100 99 99 98 72 96 99 100 54 100 98 99 99 89 89 99 97 84 96 98 99 99 0.059 0.059 0.057 0.056 0.055 0.060 0.056 0.066 0.069 0.063 0.057 0.063 0.061 0.060 0.064 0.059 0.064 0.070 0.050 0.054 0.056 0.056 0.053 0.054 0.053 0.068 0.072 0.057 0.056 0.058 0.057 0.056 0.059 0.056 0.066 0.070 Ohio Butler SCHULER AND BENDER 39.383382 -84.544413 99 94 95 96 0.070 0.070 0.076 0.072 Ohio Butler 39.529481 -84.393364 98 99 98 98 0.069 0.070 0.074 0.071 Ohio Butler 1701 Runway Dr. Ecology Research Center, Miami University, Oxford, Ohio 45056 39.532700 -84.728600 95 88 94 92 0.069 0.068 0.072 0.069 Ohio Ohio Clark Clark 5171 URBANA 5400 SPANGLER 40.001030 39.855670 -83.804560 -83.997730 100 100 100 100 100 96 100 99 0.065 0.064 0.071 0.069 0.071 0.070 0.069 0.067 Ohio Clermont 2400 CLERMONT CENTER DR. 39.082800 -84.144100 99 98 99 99 0.068 0.070 0.073 0.070 Ohio Ohio Ohio Ohio Ohio Ohio Ohio Ohio Ohio Ohio Ohio Ohio Clinton Cuyahoga Cuyahoga Cuyahoga Cuyahoga Delaware Fayette Franklin Franklin Franklin Geauga Greene 62 LAUREL DR. 891 E. 152 ST. E. 14TH & ORANGE 390 FAIR ST. 6116 WILSON MILLS 359 MAIN RD. Deer Creek State Park, Mt Sterling, OH 43143 7600 FODOR RD. 1777 E. BROAD 5750 MAPLE CANYON 13000 AUBURN 541 LEDBETTER RD., 39.430038 41.555230 41.492117 41.361890 41.537344 40.356694 39.635900 40.084555 39.965230 40.087700 41.515051 39.665750 -83.788502 -81.575256 -81.678449 -81.864608 -81.458834 -83.063971 -83.260500 -82.815550 -82.955490 -82.959773 -81.249906 -83.942680 99 99 97 96 99 99 93 100 99 100 100 100 100 99 98 100 99 100 97 100 98 100 100 100 98 94 99 99 99 98 99 99 97 100 99 100 99 97 98 98 99 99 96 100 98 100 100 100 0.070 0.071 0.066 0.059 0.061 0.066 0.069 0.070 0.069 0.068 0.065 0.066 0.070 0.068 0.063 0.066 0.072 0.068 0.070 0.071 0.064 0.063 0.073 0.071 0.071 0.070 0.063 0.068 0.071 0.067 0.067 0.072 0.067 0.071 0.077 0.069 0.070 0.069 0.064 0.064 0.068 0.067 0.068 0.071 0.066 0.067 0.071 0.068 Ohio Hamilton 11590 GROOMS RD 39.278700 -84.366250 97 98 99 98 0.071 0.072 0.075 0.072 Ohio Hamilton 6950 RIPPLE RD. 39.214870 -84.690860 99 99 99 99 0.073 0.070 0.073 0.072 Ohio Hamilton 250 WM. HOWARD TAFT 39.128860 -84.504040 100 99 99 99 0.069 0.071 0.073 0.071 Ohio Ohio Ohio Ohio Jefferson Knox Lake Lake 618 LOGAN ST. WATER PLT, SR. 314 36010 LAKESHORE 177 MAIN STREET 40.366440 40.310025 41.673006 41.726811 -80.615580 -82.691724 -81.422455 -81.242156 99 100 100 99 100 97 98 99 100 99 100 99 100 99 99 99 0.067 0.066 0.075 0.062 0.066 0.071 0.074 0.070 0.062 0.066 0.076 0.069 0.065 0.067 0.075 0.067 Ohio Lawrence S.R. 141, WILGUS 38.629010 -82.458860 97 99 98 98 0.064 0.065 0.065 0.064 (Page 514 of Total) 33B USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 468 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 Ohio Ohio Ohio Ohio Ohio Ohio Ohio Lawrence Licking Lorain Lucas Lucas Lucas Madison 460 Commerce Drive 300 LICKING VIEW DR. 4706 DETROIT RD. 348 S. ERIE 200 SOUTH RIVER RD. 1002 N. YONDOTA 940 SR 38 SW 38.508075 40.026037 41.420882 41.644067 41.494200 41.675231 39.788190 -82.659241 -82.433000 -82.095729 -83.546160 -83.718949 -83.307005 -83.476060 98 100 99 78 100 93 95 97 99 98 93 100 92 100 96 99 98 100 99 83 99 97 99 98 90 100 89 98 0.062 0.066 0.067 0.070 0.064 0.065 0.069 0.069 0.068 0.062 0.063 0.063 0.064 0.069 0.070 0.067 0.070 0.070 0.065 0.063 0.068 0.067 0.067 0.066 0.067 0.064 0.064 0.068 Ohio Ohio Ohio Ohio Ohio Ohio Mahoning Medina Miami Montgomery Noble Portage 345 OAKHILL BALLASH ROAD 3825 NORTH S. R. 589 1401 Harshman Road 58163 St. Johns Rd, Quaker City, OH 43773 1570 RAVENNA RD. 41.096142 41.060400 40.085020 39.785630 39.942800 41.182466 -80.658856 -81.923900 -84.113808 -84.134370 -81.337300 -81.330486 93 99 100 99 97 99 98 100 99 100 98 100 96 95 99 100 93 99 96 98 99 100 96 99 0.066 0.064 0.066 0.069 0.065 0.061 0.069 0.063 0.068 0.070 0.066 0.064 0.054 0.066 0.069 0.072 0.068 0.059 0.063 0.064 0.067 0.070 0.066 0.061 Ohio Ohio Ohio Ohio Preble Stark Stark Stark 6940 OXFORD GETTYSBURG RD. 515 25TH. ST. 45 S. WABASH AVENUE, S.R 93 1175 WEST VINE 39.835620 40.828052 40.712778 40.931398 -84.720490 -81.378333 -81.598333 -81.123519 100 94 96 99 100 93 93 94 100 98 97 97 100 95 95 97 0.065 0.065 0.059 0.061 0.067 0.072 0.068 0.067 0.069 0.072 0.067 0.071 0.067 0.069 0.064 0.066 Ohio Summit 800 PATTERSON AVE. 41.106486 -81.503547 100 99 99 99 0.058 0.065 0.061 0.061 Ohio Trumbull 842 YOUNGSTOWN-KINGSVILLE RD. 41.240456 -80.662559 90 100 100 97 0.065 0.070 0.071 0.068 Ohio Warren 430 SOUTHEAST ST. 39.426890 -84.200770 100 100 97 99 0.071 0.071 0.074 0.072 Ohio Ohio Washington Wood 39.432117 41.377685 -81.460443 -83.611104 93 100 100 98 100 100 98 99 0.063 0.063 0.068 0.062 0.064 0.066 0.065 0.063 Oklahoma Oklahoma Oklahoma Oklahoma Adair Caddo Canadian Cherokee 2000 4TH STREET 347 N DUNBRIDGE South Highway 59, RR1, 1795 Dahlonegah Park Road, Stilwell, Oklahoma WESTERN DELAWARE TRIBAL COMPLEX 12575 NW 10TH (WATER TOWER) P.O. BOX 948 TAHLEQUAH, OK 74464 35.750735 35.111944 35.479215 35.854080 -94.669697 -98.252778 -97.751503 -94.985964 98 87 93 100 90 94 96 97 97 49 89 95 95 77 93 97 0.063 0.055 0.068 0.061 0.062 0.057 0.066 0.061 0.058 0.054 0.062 0.058 0.061 0.055 0.065 0.060 Oklahoma Cleveland 35.320105 -97.484099 99 100 99 99 0.068 0.065 0.065 0.066 Oklahoma Oklahoma Comanche Creek S. E. 19TH STREET 2211 NW 25 Lawton, Oklahoma 73502 (LPS: Prof. Dev. Center) MANNFORD WATER PLANT 34.632980 36.105481 -98.428790 -96.361196 100 95 98 95 100 93 99 94 0.069 0.066 0.066 0.063 0.061 0.064 0.065 0.064 Oklahoma Dewey 36.158414 -98.931973 92 92 93 92 0.067 0.065 0.065 0.065 Oklahoma Oklahoma Oklahoma Oklahoma Oklahoma Kay McClain Mayes Oklahoma Oklahoma SEILING MUNICIPAL AIRPORT NORTH OF NEWKIRK OK. ON HWY 77 - EAST HOME ROAD (E0040RD) .90 MILES 310 E. BURR OAK CHEROKEE HEIGHTS DRIVE NE 10TH & STONEWALL 12880 A NE 10TH 36.956222 35.159649 36.228408 35.477036 35.477801 -97.031350 -97.473794 -95.249943 -97.494309 -97.303044 96 99 98 100 98 88 98 97 99 97 97 99 100 99 98 94 99 98 99 98 0.069 0.069 0.060 0.069 0.066 0.063 0.065 0.065 0.068 0.067 0.059 0.065 0.061 0.065 0.064 0.063 0.066 0.062 0.067 0.065 (Page 515 of Total) 34B USCA Case #17-1172 State Name County Name Document #1683752 Street Address Filed: 07/12/2017 Site Latitude Site Longitude 2014 Percent Complete Page 469 of 598 2015 Percent Complete 2016 Percent Complete 2014-2016 Average Percent Complete 2014 4th 2015 4th 2016 4th Highest Highest Highest Daily Daily Daily Max Max Max Value Value Value Design Value 20142016 Oklahoma Oklahoma 2501 E. Memorial Rd. (OKLAHOMA CHRISTIAN UNIVERSITY) 35.614131 -97.475083 98 93 91 94 0.070 0.068 0.068 0.068 Oklahoma Ottawa QUAPAW TRIBE'S INDUSTRIAL PARK, MIAMI 36.922222 -94.838889 96 93 95 95 0.055 0.056 0.053 0.054 Oklahoma Oklahoma Pittsburg Sequoyah 104 AIRPORT ROAD 207 Cherokee Boulevard, Roland, OK 74954 34.902270 35.408140 -95.784375 -94.524413 93 88 100 99 99 90 97 92 0.062 0.060 0.060 0.062 0.059 0.058 0.060 0.060 Oklahoma Oklahoma Oklahoma Tulsa Tulsa Tulsa 1100 SOUTH OSAGE DRIVE 502 EAST 144TH. PL. 18707 E. 21ST STREET 36.357438 35.953708 36.133802 -95.999247 -96.004975 -95.764537 97 99 95 98 84 99 17 83 98 71 89 97 0.065 0.062 0.063 0.066 0.061 0.065 0.060 0.064 0.063 0.063 0.062 0.063 Oklahoma Tulsa 3520 1/2 N. PEORIA 36.204902 -95.976537 100 95 96 97 0.065 0.068 0.062 0.065 Oregon Clackamas CARUS TRAILER/SPANGLER RD 45.259280 -122.588151 99 96 99 98 0.062 0.069 0.064 0.065 Oregon Columbia SAUVIE ISLAND-SSB/ROUTE 1, BOX 442 45.768531 -122.772100 99 97 99 98 0.053 0.058 0.051 0.054 Oregon Jackson 7112 RAPP LANE, TALENT 42.229891 -122.787700 98 91 85 91 0.059 0.069 0.049 0.059 Oregon Lane AMAZON PARK/499 E 29TH 44.026312 -123.083737 99 99 99 99 0.058 0.068 0.057 0.061 Oregon Lane 79980 DELIGHT VALLEY SCHOOL RD, SAGINAW 43.834500 -123.035300 99 99 99 99 0.058 0.071 0.056 0.061 Oregon Marion CASCADE JR HIGH 10226 MARION RD TURNER O 44.810290 -122.915085 94 79 98 90 0.066 0.065 0.065 0.065 Oregon Multnomah SE LAFAYETTE/5824 SE LAFAYETTE 45.496641 -122.602877 99 99 96 98 0.055 0.057 0.055 0.055 45.828968 -119.262991 95 98 89 94 0.064 0.070 0.063 0.065 45.393497 -122.747894 92 100 95 96 0.053 0.052 0.048 0.051 45.402446 39.923100 -122.854437 -77.307800 98 94 99 97 98 97 98 96 0.057 0.063 0.063 0.067 0.058 0.071 0.059 0.067 40.465420 -79.960757 100 97 96 98 0.065 0.071 0.067 0.067 40.375644 -80.169943 99 100 99 99 0.065 0.068 0.072 0.068 40.617488 -79.727664 99 93 86 93 0.071 0.074 0.067 0.070 HERMISTON MUNICIPAL AIRPORT, 1600 AIRPORT WAY, HERMISTON 6745 Bradbury Court, Tualatin, OR (NO2 roadway site) 17180 SW Lasich Lane, Sherwood - Lasich and Roy Rogers (SLR) 747 Winding Rd, Biglerville, PA 17307 Oregon Umatilla Oregon Washington Oregon Pennsylvania Washington Adams Pennsylvania Allegheny Pennsylvania Allegheny Pennsylvania Allegheny 301 39th St, Pittsburgh, PA 15201 (Lawrenceville) 3640 Old Oakdale Rd, McDonald, PA 15057 (South Fayette) 1500 Pacific Ave, Natrona Heights, PA 15065 (Harrison) Pennsylvania Armstrong GLADE DR. & NOLTE RD. KITTANNING 40.814183 -79.564750 100 100 93 98 0.068 0.070 0.068 0.068 Pennsylvania Beaver ROUTE 168 & TOMLINSON ROAD 40.562520 -80.503948 98 98 95 97 0.069 0.070 0.069 0.069 (Page 516 of Total) 35B H- .. a man BF gum Wean 0F CULUMEIBY I m: cuwmam 013mm I IN THE UNITED STATES COURT OF APPEALS may _1 20" was 63? FOR THE DISTRICT OF COLUMBIA RECEIVEB CLERK STATE OF NEW YORK, STATE OF CALIFORNIA, STATE OF CONNECTICUT, STATE OF DELAWARE, STATE OF ILLINOIS, STATE OF IOWA, . STATE OF MAINE, COMMONWEALTH Casl 116.1 1 3 5 OF MASSACHUSETTS, STATE OF MINNESOTA, STATE OF NEW MEXICO, STATE OF OREGON, STATE OF RHODE ISLAND, COMMONWEALTH OF STATE OF VERMONT, STATE OF WASHINGTON, and DISTRICT OF COLUMBIA, Petitioners, V. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, and SCOTT PRUITT, as Administrator of the US. Environmental Protection Agency, Respondents. PETITION FOR REVIEW Pursuant to Clean Air Act 307(b)(1), 42 USC. 7607(b)(1), Rule 15 Of the Federal Rules of Appellate Procedure, and DC. Circuit Rule 15, the States Of New York, California, Connecticut, Delaware, Illinois, Iowa, Maine, Minnesota, New Mexico, Oregon, Rhode Island, Vermont, and Washington, the Commonwealths of Massachusetts and and the District of Columbia (collectively, Petitioners) hereby petition this Court for review of the final action of Respondents United States Environmental Protection Agency and Administrator Scott Pruitt extending the deadline for promulgating initial area designations for the 2015 ozone national ambient air quality standards, which Respondents announced in a Federal Register notice published at 82 Fed. Reg. 29,246 (June 28, 2017) and titled ?Extension of Deadline for Promulgating Designations for the 2015 Ozone National Ambient Air Quality Standards? (Attachment A) and in letters to state governors dated June 6, 2017, an example of which is attached (Attachment B). DATED: July 31, 2017 Respectfully submitted, FOR THE STATE OF NEW YORK ERIC T. SCHNEIDERMAN ATTORNEY GENERAL Michael J. Myers Senior Counsel Morgan A. Costello Brian Lusignan Assistant Attorneys General Environmental Protection Bureau The Capitol I Albany, NY 12224 (518) 776-2400 Attorneys for the State of New York, on behalf of the New York State Department of Environmental Conservation FOR THE STATE OF CALIFORNIA FOR THE STATE OF CONNECTICUT XAVIER BECERRA ATTORNEY GENERAL OF GEORGE EPSEN CALIFORNIA ATTORNEY GENERAL .?12166 Per will Alt?fC/Ltar 3r; Willi Robert W. Byrnii: Matthew I. Levine I Senior Assistant Attorney General Scott N. Koschwitz Gavin G. McCabe Assistant Attorneys General Supervising Deputy Attorney General Of?ce of the Attorney General Melinda Pilling PO. Box 120, 55 Elm Street Timothy E. Sullivan . Hartford, CT 06141-0120 Deputy Attorneys General (860) 808-5250 455 Golden Gate Ave, Suite 11000 San Francisco, CA 94102 (415) 703-5585 Attorneys for State of California, by and through the Air Resources Board and Attorney General Xavier Becerra FOR THE STATE OF DELAWARE FOR THE STATE OF ILLINOIS MATTHEW P. DENN LISA MADIGAN ATTORNEY GENERAL ATTORNEY GENERAL .. ?at, .. - (?4'51'7?92?1 *5 't Cit/ll? t" ctr/?lh Valerie S. Etlg?? Matthew J. Dunn I Deputy Attorney General Gerald T. Karr Delaware Department of Justice James P. Gignac 102 West Water Street, 3d Floor Assistant Attorneys General Dover, DE 19904 69 W. Washington St., 18th Floor (302) 739-4636 Chicago, IL 60602 (312) 814-0660 FOR THE STATE OF IOWA THOMAS J. MILLER ATTORNEY GENERAL b. Jacob Larson Assistant Attorney General Of?ce of Iowa Attorney General Hoover State Of?ce Building 1305 E. Walnut Street, Floor Des Moines, Iowa 50319 (515) 281-5341 FOR THE STATE OF MAINE JANET T. MILLS ATTORNEY GENERAL all/1R Gerald D. Reid Natural Resources Division Chief 6 State House Station Augusta, ME 04333 (207) 626-8800 FOR THE COMMONWEALTH OF MASSACHUSETTS MAURA HEALEY ATTORNEY 1 - Lit/11M Ml; Carol Iancu Assistant Attorney General Environmental Protection Division One Ashburton Place, 18th Floor Boston, MA 02108 (617) 963?2428 FOR THE STATE OF MINNESOTA LORI SWANSON ATTORNEY GENERAL it ,4 . t; 5: if) but NW. Max Kieley I I Assistant Attorney General 445 Minnesota Street, Suite 900 St. Paul, MN 55101-2127 (651) 757?1244 Attorneys for State ofMt'nnesota, by and through the Minnesota Pollution Control Agency FOR THE STATE OF NEW MEXICO HECTOR BALDERAS ATTORNEY GENERAL q, Lillg?j?fm William Grantham Brian MoMath Assistant Attorneys General Of?ce of the Attorney General 408 Galisteo Street Villagra Building Santa Fe, NM 8750] (505) 490?4060 60 in? (?lurk FOR THE STATE OF OREGON ELLEN F. ROSENBLUM ATTORNEY GENERAL Frilti'z 6173.53- Paul Garrahan Attorney-in?Charge Natural Resources Section Oregon Department of Justice 1 162 Court Street NE Salem, OR 97301-4096 (503) 947?4593 [1 FOR THE STATE OF RHODE ISLAND PETER F. ATTORNEY GENERAL 97ft - fr? Gregory Schultz Special Assistant Attorney General Rhode Island Department of Attorney General 150 South Main Street Providence, RI 02903 (401) 274?4400 FOR THE COMMONWEALTH OF JOSH SHAPIRO ATTORNEY GENERAL Steven J. Santarsiero (Pro Hac Vice Admission Pending) Chief Deputy Attorney General Michael J. Fischer Chief Deputy Attorney General Kristen M. Furlan Assistant Director Bureau of Regulatory Counsel PA Department of Environmental Protection PA Of?ce of the Attorney General 1000 Madison Avenue, Suite 310 Norristown, PA 19403 (610) 631-5971 FOR THE STATE OF VERMONT THOMAS J. DONOVAN, JR. ATTORNEY GENERAL rVgangtir-..-? lin?ilaf/m?wag Wm Nicholas F. Persampieiri Assistant Attorney General Of?ce of the Attorney General 109 State Street Montpelier, VT 05609-1001 (802) 828-3186 FOR THE STATE OF WASHINGTON ROBERT W. FERGUSON ATTORNEY GENERAL Katharine G. Shirey '1 Assistant Attorney General Of?ce of the Attorney General PO. Box 40117 Olympia, WA 98504?0117 (360) 586-6769 I. i ?it; FOR THE DISTRICT OF COLUMBIA KARL A. RACINE ATTORNEY GENERAL ?r ll ng't?l?? ?at/TR James C. McKay? r. Senior Assistant Attorney General Of?ce of the Attorney General 441 Fourth Street, NW Suite 630 South Washington, DC 20001 (202) 724-5690 CERTIFICATEOF SERVICE I hereby certify that pursuant to Circuit Rule 15(a), a copy of the foregoing Petition for Review was served on July 31, 2017 by first-class mail, postage prepaid on the following: Hon. E. Scott Pruitt, Administrator Office of the Administrator (1101A) Environmental Protection Agency 1.200 Ave., NW Washington, DC 20460 Hon. Jeff Sessions Attorney General of the United States US. Department of Justice 950 Ave., NW Washington, DC 20530 Correspondence Control Unit Office of General Counsel (2311) United States Environmental Protection Agency 1200 Ave, NW Washington, DC 20460 .- ATTACHMENT A .1, 29246 Federal Register/Vol. 82, No. 123/Wednesday, June 28, 2017/Rules and Regulations withdrawn or denied. The proceeds of any such fees will be used to pay the remaining portion of the Agency?s cost of providing credit assistance and the costs of retaining expert firms, including financial, engineering, and legal services, in the field of municipal and project finance, to assist in the underwriting of the Federal credit instrument. All of, or a portion of, this fee may be waived. Servicing fee. EPA will require borrowers to pay a servicing fee for each credit instrument approved for funding. Separate fees may apply for each type of credit instrument a loan guarantee, a secured loan with a single disbursement, or a secured loan with multiple disbursements), depending on the costs of servicing the credit instrument as determined by the Administrator. Such fees will be set at a level sufficient to enable the EPA to recover all or a portion of the costs to the Federal Government of servicing WIFIA credit instruments. Optional supplemental fee. If, in any given year, there is insufficient budget authority to fund the credit instrument for a qualified project that has been selected to receive assistance under WIFIA, EPA and the approved applicant may agree upen a supplemental foe to be paid by or on behalf of the approved applicanl at the time of execution of the term sheet to reduce the subsidy cost of that. project. No such fee may be included among eligible project costs. Reduced fees. To the extent that Congress appropriates funds in any given year beyond those sufficient to cover internal administrative costs, EPA may utilize such appropriated funds to reduce fees that would otherwise be charged under paragraph of this section. Extraordinary expenses. EPA may require payment in full by the borrower of additional fees, in an amount determined by EPA, and of related fees and expenses of its independent consultants and outside counsel, to the extent that such fees and expenses are incurred directly by EPA and to the extent such third parties are not paid directly by the borrower, in the event that a borrower experiences difficulty relating to technical, financial, or legal matters or other events engineering failure or financial workouts] which require EPA to incur time or expenses beyond standard monitoring. Doc. 2017?13438 Filed am] BILLING cons ENVIRONMENTAL PROTECTION AGENCY 40 CFR PART 81 Extension of Deadline for Promulgating Designations for the 2015 Ozone National Ambient Air Quality Standards AGENCY: Environmental Protection Agency ACTION: Extension of deadline for promulgating designations. SUMMARY: The Environmental Protection Agency is announcing that it is using its authority under the Clean Air Act to extend by 1 year the deadline for promulgating initial area designations for the ozone national ambient air quality standards that were promulgated in October 2015. The new deadline is October 1, 2018. DATES: The deadline for the EPA to promulgate initial designations for the 2015 ozone NAAQS is October 1, 2018. FOR FURTHER INFORMATION CONTACT: For questions regarding this action, contact. Denise Scott, Air Quality Planning Division, Office of Air Quality Planning and Standards, Mail Code C539-04, Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: [919.) 541? 4208; email address: scott.denise@ epa.gov. SUPPLEMENTARY INFORMATION: 1. General Information A. Does this action apply to me? Entities potentially affected by this action include state, local and tribal governments that would participate in the initial area designation process for the 2015 ozone standards. B. Where can [get a copy oftln?s document and other related information? The EPA has established a docket for designations for the 201 5 ozone NAAQS under Docket ID No. 2017?0223. All documents in the docket are listed in the littp:// index. Although listed in the index, some information is not publicly available, confidential business information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http:// or in hard copy at the EPA Docket Center EPA West, Room 3334. 1301 Constitution Avenue NW., Washington, DC. The Public Reading Room is open from 8:30 am. to 4:30 p.1n., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566?1744, and the telephone number for the EPA Docket Center is (202] 566?1742. An electronic copy of this notice is also available at ozone-designations along with other information related to designations for the 2015 ozone NAAQS. II. Designations Requirements On October 1, 2015, the EPA signed a notice of final rulemaking that revised the 8-hour primary and secondary ozone NAAQS [80 FR 65292; October 26, 2015]. The primary standard was lowered from 0.075 parts per million [ppm] to a level of 0.070 ppm. The EPA also revised the secondary standard by making it identical in all respects to the revised primary standard. (The previous ozone NAAQS were set in 2008 and remain effective.) After the EPA establishes or revises a NAAQS pursuant: to CAA section 109, the CAA directs the EPA and the states to begin taking steps to ensure that those NAAQS are met. The first step is to identify areas of the country that do not meet the new or revised NAAQS. This step is known as the initial area designations. Section of the CAA provides that, ?By such date as the Administrator may reasonably require, but not later than 1 year after promulgation of a new or revised national ambient air quality standard for any pollutant: under section [109], the Governor of each State shall submit to the Administrator a list of all areas (or portions thereof] in the State" that. designates those areas as nonattainment, attainment, or unclassifiable. The CAA defines an area as nonattainment if it is violating the NAAQS or if it is contributing to a violation in a nearby area. 42 U.S.C. The CAA further provides, ?Upon promulgation or revision of a national ambient air quality standard, the Administrator shall promulgate the designations of all areas [or portions thereof] as expeditiously as practicable, but in no case later than 2 years from the date of promulgation of the new or revised national ambient air quality standard. Such period may be extended for up to one year in the event the Administrator has insufficient information to promulgate the Federal Register/Vol. 82, No. 123/Wednesday, June 28, 2017/Rules and Regulations 29247 designations.? 42 U.S.C. After the states submit their recommendations, but no later than 120 days prior to promulgating designations, the EPA is required to notify a state of any intended modifications to the state's recommended designation. The state then has an opportunity to demonstrate why any proposed modification is inappropriate. Whether or not a state provides a recommendation, the EPA must promulgate the designation that the agency deems appropriate within 2 years of promulgation of the NAAQS (or within 3 years if the EPA extends the deadline]. For the 2015 ozone NAAQS, the deadline for states to submit designation recommendations to the EPA for their areas was October 1, 2016. The EPA has been evaluating these recommendations and conducting additional analyses to determine whether it is necessary to modify any of the state recommendations. Extension of Deadline for Promulgating Designations for the 2015 NAAQS In this action, the EPA is announcing that it is using its authority under section of the CAA to extend by 1 year the deadline for promulgating initial area designations for the 2015 ozone NAAQS. The new deadline is October 1, 2018. For the reasons explained in this notice, the EPA Administrator has determined that there is insufficient information to complete the designations by October 1. 2017. Following the recent change in administrations, the agency is currently evaluating a host of complex issues regarding the 2015 ozone NAAQS and its implementation, such as understanding the role of background ozone levels and appropriately accounting for international transport. The Administrator has determined that he cannot assess whether he has the necessary information to finalize designations until additional analyses from this evaluation are available. In addition, pursuant to language in the recently-enacted Fiscal Year 2017 omnibus bill. the Administrator is establishing an Ozone Cooperative Compliance Task Force to develop additional flexibilities for states to comply with the ozone standard. It is possible the outcome of that effort could identify flexibilities that could impact the designations process. In light of the analyses currently underway at the agency, the Administrator has determined he needs additional time to consider completely all designation recommendations provided by state gOVernors pursuant to CAA section including full consideration of exceptional events impacting designations, and determine whether they provide sufficient information to finalize designations. We also note that new agency officials are currently reviewing the 2015 ozone NAAQS rule. The Administrator has determined that in light of the uncertainty of the outcome of that review, there is insufficient information to promulgate designations by October 1, 2017. List of Subjects in 40 CFR Part 81 Environmental protection, Air pollution control, National parks, Wilderness areas. Dated: June 21,2017. E. Scott Pruitt, Administrator. Doc. 2017#1343.7 Filed 6?27?17; 8:45 am] BILLING CODE ATTACHMENT I into? E. Scorr Pmurr ADMINISTRATOR June 6, 2017 The Honorable Andrew Cuomo Governor oi?New York State Capitol Albany, New York 12224 Dear Governor Cuo mo: 1 am writing to update you on the status of the US. Environmental Protection Agency?s el'lforts related to the National Ambient Air Quality Standards (NAAQS) for ozone promulgated in October 2015. Pursuant to section 107(d)(1)(B) ol?the Clean Air Act (CAA), I am extending the deadline for promulgating initial area designations for the 2015 ozone NAAQS by one year. I have determined that there is insuf?cient information, and taking additional time is appropriate in order to consider completely all designation recommendations provided by state governors pursuant to CAA section 107(d)(1)(A) and to rely fully on the most recent air quality data. This additional time will also provide the Agency time to complete its review of the 2015 ozone NAAQS, prior to taking this initial implementation step. Although the new ozone standard was set on October 1, 2015, there remains a host of complex issues that could undermine associated compliance efforts by states, localities and regulated entities. As part of the review process, the Agency is evaluating these issues primarily focusing on: fully understanding the role of background ozone levels; appropriately accounting for international tranSpon; and, timely consideration of exceptional events demonstrations. Additionally, pursuant to language in the recently-enacted FY 2017 omnibus bill, I have established an Ozone Cooperative Compliance Task Force to develop additional flexibilities for states to comply with the ozone standard. States have made tremendous progress and signi ticant investment cleaning up the air. Since 1980, total emissions of the six principal air pollutants have dropped by 63 percent and ozone levels have declined by 33 percent. Despite the continued improvement of air quality, costs associated with compliance of the ozone NAAQS have significantly increased. 1 am committed to working with you and your local of?cials to effectively implement the ozone standard in a manner that is supportive of your air quality improvement efforts. without interfering with local decisions or impeding economic growth. 1200 Ava. NW 0 Man. Conic 1101A - DC 20160 - (202) 561-1700 - Fax: (2112) .3014 Lit) This paper .3 printed vegelabie.o.l.based and ls 100-percent poslconsumer recycled material. chlorine-lree-processed and recyclable I appreciate the information you and your staff have shared with EPA already as part of this process. I am con?dent this progress will continue as we work tgether towards our shared goal of clean air, a robust economy and stronger, healthier communities. If you have questions or concerns, please contact me: or your staff may contact Troy Lyons, Associate Administrator for the Of?ce of Congressional and Intergovernmental Relations, at lyons.troy@epa.gov or (202) 564- 4987. E. Scull Pruill 012324105 678ÿ ÿ ÿ ÿ ÿ ÿ ÿ4103ÿ ÿ ÿ ÿ ÿ678ÿ ÿ! 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C6434ÿ6*5ÿ>9683B3.4ÿ=-8ÿM6Aÿ>6*ÿC.ÿD=8.ÿ8.4M=*43L.ÿ<= 9=>69ÿ*..54Kÿ RS*5.8ÿM8.L3=-4ÿ25D3*34<86<3=*4/ÿ012ÿ@=-95ÿ=B<.*ÿB639ÿ<=ÿD..<ÿ5.43;*6<3=* 5.6593*.4/ÿ6*5ÿ.*ÿ@63<ÿ<=ÿC.ÿ4-.5ÿCAÿ6><3L34<ÿ;8=-M4ÿ6*5ÿ=.84/ÿ6;8..3*;ÿ3*ÿ6 4.<<9.D.*<ÿ<=ÿ4.<ÿ4>?.5-9.4ÿB=8ÿ5.43;*6<3=*/Tÿ4635ÿUVWÿWYZ[\[]^_`^a_ÿbca^^ V_d[^^eÿÿRf.ÿ5=ÿ*=<ÿC.93.L.ÿ3*ÿ8.;-96<3=*ÿ8=-;?ÿ93<3;6<3=*/ÿ6*5ÿ@.ÿ<6N.ÿ5.6593*.4 4.83=-49AKÿf.ÿ694=ÿ<6N.ÿ.ÿ4<6<-<.ÿ6*5ÿ.ÿ6-=832014 14:07 Sep 27, 2017 Jkt 241001 Electronic Access and Filing 23 CFR Part 490 [FR Doc. 2017-20785 Filed 9-27-17; 8:45 am] Because this rule involves a foreign affairs function of the United States, it is not subject to either Executive Order 12866 or Executive Order 13771. This regulation is being issued in accordance with 19 CFR 0.1(a)(1). The effective date of the amendments to 23 CFR 490.105(c)(5) and (d)(1)(v), 490.107(b)(1)(ii)(H), (b)(2)(ii)(J), (b)(3)(ii)(I), and (c)(4), 490.109(d)(1)(v) and (f)(1)(v), 490.503(a)(2), 490.505 (Definition of Greenhouse gas (GHG)), 490.507(b), 490.509(f), (g) and (h), 490.511(a)(2), (c), (d), and (f), and 490.513(d) published on January 18, 2017, at 82 FR 5970, is September 28, 2017. FOR FURTHER INFORMATION CONTACT: Christopher Richardson, Assistant Chief Counsel for Legislation, Regulations, and General Law, Office of Chief Counsel, Federal Highway Administration, 1200 New Jersey Avenue SE., Washington, DC 20590. Telephone: (202) 366-0761. Office hours are from 8:00 a.m. to 4:30 p.m. e.t., Monday through Friday, except Federal holidays. SUPPLEMENTARY INFORMATION: DATES: A copy of the Notice of Proposed Rulemaking (NPRM), all comments received, the Final Rule, and all background material may be viewed online at http://www.regulations.gov using the docket numbers listed above. A copy of this document will be placed on the docket. Electronic retrieval help and guidelines are available on the Web site. It is available 24 hours each day, 365 days each year. An electronic copy of this document may also be downloaded from the Office of the Federal Register's Web site at http:// www.ofr.gov and the Government Publishing Office's Web site at http:// www.gpo.gov. Kevin K. McAleenan, Acting Commissioner, U.S. Customs and Border Protection. Approved: September 25, 2017. Timothy E. Skud, Deputy Assistant Secretary of the Treasury. National Performance Management Measures; Assessing Performance of the National Highway System, Freight Movement on the Interstate System, and Congestion Mitigation and Air Quality Improvement Program Executive Orders 12866 and 13771 jstallworth on DSKBBY8HB2PROD with RULES PART 12--SPECIAL CLASSES OF MERCHANDISE 45179 This document announces the effective date for specific portions of the National Performance Management measures; Assessing Performance of the National Highway System, Freight Movement on the Interstate System, and Congestion Mitigation and Air Quality Improvement Program Final Rule (PM#3). SUMMARY: PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 On May 19, 2017, at 82 FR 22879, FHWA announced that the majority of the PM#3 Final Rule would become effective on May 20, 2017, and that the portions of the PM#3 Final Rule pertaining to the measure on the percent change in CO2 emissions from the reference year 2017, generated by onroad mobile sources on the National Highway System (the GHG) measure would be further suspended pending additional rulemaking. This document confirms that the following sections of the Final Rule are effective as of September 28, 2017: 1. 23 CFR 490.105(c)(5) 2. 23 CFR 490.105(d)(1)(v) 3. 23 CFR 490.107(b)(1)(ii)(H) 4. 23 CFR 490.107(b)(2)(ii)(J) 5. 23 CFR 490.107(b)(3)(ii)(I) 6. 23 CFR 490.107(c)(4) 7. 23 CFR 490.109(d)(1)(v) 8. 23 CFR 490.109(f)(1)(v) 9. 23 CFR 490.503(a)(2) E:\FR\FM\28SER1.SGM 28SER1 45180 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Rules and Regulations 10. 23 CFR 490.505 (Definition of Greenhouse gas (GHG)) 11. 23 CFR 490.507(b) 12. 23 CFR 490.509(f) 13. 23 CFR 490.509(g) 14. 23 CFR 490.509(h) 15. 23 CFR 490.511(a)(2) 16. 23 CFR 490.511(c) 17. 23 CFR 490.511(d) 18. 23 CFR 490.511(f) 19. 23 CFR 490.513(d). The FHWA recognizes that there are short timeframes to comply with the October 1, 2018 reporting deadline. However, FHWA expects that the burden to comply with the upcoming reporting deadline will be minimal, consisting mostly of preliminary targetsetting activities using existing data sources. The FHWA has initiated additional rulemaking procedures proposing to repeal the GHG measure (RIN 2125- AF76) and anticipates publishing an NPRM in 2017 with a goal of issuing a Final Rule in Spring 2018. jstallworth on DSKBBY8HB2PROD with RULES Waiver of Rulemaking Under the Administrative Procedure Act (APA) (5 U.S.C. 553), FHWA generally offers interested parties the opportunity to comment on proposed regulations and publishes rules not less than 30 days before their effective dates. However, the APA provides that an agency is not required to conduct notice-and-comment rulemaking or delay effective dates when the agency, for good cause, finds that the requirement is impracticable, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(B) and (d)(3)). There is good cause to waive these requirements here as unnecessary, because this rule merely ceases the suspension of the Final Rule pending additional rulemaking, as provided for in the May 19, 2017 document at 82 FR 22879, thus putting in effect the requirements of the above-referenced sections of the Final Rule as previously promulgated after notice and comment. The cessation of the suspension is therefore not significant in nature and impact, and does not impose new burdens on State departments of transportation and Metropolitan Planning Organizations. List of Subjects in 23 CFR Part 490 Bridges, Highway safety, Highways and roads, Incorporation by reference, Reporting and recordkeeping requirements. VerDate Sep<11>2014 14:07 Sep 27, 2017 Jkt 241001 Issued on: September 22, 2017. Brandye L. Hendrickson, Acting Administrator, Federal Highway Administration. [FR Doc. 2017-20804 Filed 9-25-17; 4:15 pm] BILLING CODE 4910-22-P EQUAL EMPLOYMENT OPPORTUNITY COMMISSION 29 CFR Part 1610 RIN 3046-AA90 Availability of Records Equal Employment Opportunity Commission. ACTION: Final rule. AGENCY: The Equal Employment Opportunity Commission (''EEOC'' or ''Commission'') is issuing a final rule revising its Freedom of Information Act (FOIA) regulations in order to implement the substantive and procedural changes to the FOIA identified in the FOIA Improvement Act of 2016 and update two district office addresses and the Office of Legal Counsel's fax number. DATES: Effective September 28, 2017. FOR FURTHER INFORMATION CONTACT: Stephanie D. Garner, Assistant Legal Counsel, FOIA Programs, or Draga G. Anthony, Senior Attorney Advisor, Office of Legal Counsel, U.S. Equal Employment Opportunity Commission, at (202) 663-4640 (voice) or (202) 663- 7026 (TTY). These are not toll-free telephone numbers. This final rule also is available in the following formats: Large print, Braille, audiotape, and electronic file on computer disk. Requests for this final rule in an alternative format should be made to EEOC's Publications Center at 1-800- 669-3362 (voice) or 1-800-800-3302 (TTY). SUMMARY: SUPPLEMENTARY INFORMATION: Introduction On December 29, 2016, EEOC published in the Federal Register an interim final rule setting forth revisions to EEOC's FOIA regulations at 29 CFR part 1610. 81 FR 95869 (2016). The purpose of the revisions is to update the Commission's FOIA regulations so that they are consistent with current Commission practice in responding to FOIA requests as reflected in the FOIA Improvement Act of 2016. The revisions also are intended to update two district office addresses and the Office of Legal Counsel's fax number. The interim final rule sought public comments which were due on or before January 30, 2017. PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 EEOC received four comments in response to the interim final rule. Two comments were submitted by an individual, and the remaining two comments were submitted by the National Archives and Records Administration's Office of Government Information Services (hereinafter ''OGIS''). The individual commenter suggested that EEOC reconsider the fifteen cent per page duplication fee charged for copies. This comment is outside the scope of the interim final rule, which did not propose changes to the duplication fees associated with processing FOIA requests. Therefore, the EEOC declines to change the duplication fees. The second comment asked the EEOC to remove the word ''professional'' in 1610.9(f)(3), which identifies the requirements of a requester seeking expedited processing. Congress strongly favors uniform FOIA regulations. The Office of Information Policy, to assist agencies in issuing uniform regulations, provided a template for agencies to utilize when revising FOIA regulations. In order to conform with the Office of Information Policy template language, the EEOC declines to remove the word ''professional.'' The Commission has considered carefully the comments from OGIS and has made some changes to the final rule in response to them. The OGIS comments concerning Sections 1610.11 and 1610.13 and EEOC's changes to the final rule are discussed in more detail below. Section 1610.2--Statutory Requirements The EEOC determined that the final two sentences of Section 1610.2(a) of the Draft Final Rule should be deleted. Those sentences read as follows: ''As a matter of policy, the Commission may make discretionary disclosures of records or information exempt from disclosure under the FOIA whenever disclosure would not foreseeably harm an interest protected by the FOIA exemption. This policy does not create any right enforceable in Court.'' The final rule now more closely aligns with the statutory language at 5 U.S.C. 552(a)(8). The FOIA Improvement Act of 2016 codified the foreseeable harm standard; therefore, release of the records is no longer a matter of agency policy. Records must be released unless there is a risk of foreseeable harm. Section 1610.5--Request for Records Section 1610.5(a)(2), of the interim final rule said that ''(2)A requester who is making a request for records about himself or herself must comply with the E:\FR\FM\28SER1.SGM 28SER1 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Rules and Regulations exchanged that reflect the extension of the agreement. Accordingly, CBP is amending 19 CFR 12.104g(a) in order to reflect the extension of the import restrictions pursuant to the agreement. The Designated List of Archaeological Materials and Ecclesiastical Ethnological Materials from Guatemala covered by these import restrictions is set forth in CBP Dec. 12–17. The Designated List may also be found online at https://eca.state.gov/culturalheritage-center/cultural-propertyprotection/bilateral-agreements/ guatemala. The restrictions on the importation of these archaeological and ecclesiastical ethnological materials from Guatemala are to continue in effect for an additional five years. Importation of such material continues to be restricted unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met. Inapplicability of Notice and Delayed Effective Date This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure (5 U.S.C. 553(a)(1)). In addition, CBP has determined that such notice or public procedure would be impracticable and contrary to the public interest because the action being taken is essential to avoid interruption of the application of the existing import restrictions (5 U.S.C. 553(b)(B)). For the same reason, a delayed effective date is not required under 5 U.S.C. 553(d)(3). Regulatory Flexibility Act Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. 1. The general authority citation for part 12 and the specific authority citation for § 12.104g continue to read as follows: ■ Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624; * * * * * Sections 12.104 through 12.104i also issued under 19 U.S.C. 2612; * * * § 12.104g(a) * * [Amended] 2. In § 12.104g(a), the table of the list of agreements imposing import restrictions on described articles of cultural property of State Parties is amended in the entry for Guatemala by adding the words ‘‘extended by CBP Dec. 17–14’’ after the words ‘‘CBP Dec. 12–17’’ in the column headed ‘‘Decision No.’’. ■ [Docket No. FHWA–2013–0054] Background BILLING CODE 9111–14–P DEPARTMENT OF TRANSPORTATION Federal Highway Administration RIN 2125–AF54 Signing Authority AGENCY: Federal Highway Administration (FHWA), Department of Transportation (DOT). ACTION: Final regulation; announcement of effective date. List of Subjects in 19 CFR Part 12 Cultural property, Customs duties and inspection, Imports, Prohibited merchandise. Amendment to CBP Regulations For the reasons set forth above, part 12 of Title 19 of the Code of Federal Regulations (19 CFR part 12) is amended as set forth below: VerDate Sep<11>2014 14:07 Sep 27, 2017 Jkt 241001 Electronic Access and Filing 23 CFR Part 490 [FR Doc. 2017–20785 Filed 9–27–17; 8:45 am] Because this rule involves a foreign affairs function of the United States, it is not subject to either Executive Order 12866 or Executive Order 13771. This regulation is being issued in accordance with 19 CFR 0.1(a)(1). The effective date of the amendments to 23 CFR 490.105(c)(5) and (d)(1)(v), 490.107(b)(1)(ii)(H), (b)(2)(ii)(J), (b)(3)(ii)(I), and (c)(4), 490.109(d)(1)(v) and (f)(1)(v), 490.503(a)(2), 490.505 (Definition of Greenhouse gas (GHG)), 490.507(b), 490.509(f), (g) and (h), 490.511(a)(2), (c), (d), and (f), and 490.513(d) published on January 18, 2017, at 82 FR 5970, is September 28, 2017. FOR FURTHER INFORMATION CONTACT: Christopher Richardson, Assistant Chief Counsel for Legislation, Regulations, and General Law, Office of Chief Counsel, Federal Highway Administration, 1200 New Jersey Avenue SE., Washington, DC 20590. Telephone: (202) 366–0761. Office hours are from 8:00 a.m. to 4:30 p.m. e.t., Monday through Friday, except Federal holidays. SUPPLEMENTARY INFORMATION: DATES: A copy of the Notice of Proposed Rulemaking (NPRM), all comments received, the Final Rule, and all background material may be viewed online at http://www.regulations.gov using the docket numbers listed above. A copy of this document will be placed on the docket. Electronic retrieval help and guidelines are available on the Web site. It is available 24 hours each day, 365 days each year. An electronic copy of this document may also be downloaded from the Office of the Federal Register’s Web site at http:// www.ofr.gov and the Government Publishing Office’s Web site at http:// www.gpo.gov. Kevin K. McAleenan, Acting Commissioner, U.S. Customs and Border Protection. Approved: September 25, 2017. Timothy E. Skud, Deputy Assistant Secretary of the Treasury. National Performance Management Measures; Assessing Performance of the National Highway System, Freight Movement on the Interstate System, and Congestion Mitigation and Air Quality Improvement Program Executive Orders 12866 and 13771 jstallworth on DSKBBY8HB2PROD with RULES PART 12—SPECIAL CLASSES OF MERCHANDISE 45179 This document announces the effective date for specific portions of the National Performance Management measures; Assessing Performance of the National Highway System, Freight Movement on the Interstate System, and Congestion Mitigation and Air Quality Improvement Program Final Rule (PM#3). SUMMARY: PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 On May 19, 2017, at 82 FR 22879, FHWA announced that the majority of the PM#3 Final Rule would become effective on May 20, 2017, and that the portions of the PM#3 Final Rule pertaining to the measure on the percent change in CO2 emissions from the reference year 2017, generated by onroad mobile sources on the National Highway System (the GHG) measure would be further suspended pending additional rulemaking. This document confirms that the following sections of the Final Rule are effective as of September 28, 2017: 1. 23 CFR 490.105(c)(5) 2. 23 CFR 490.105(d)(1)(v) 3. 23 CFR 490.107(b)(1)(ii)(H) 4. 23 CFR 490.107(b)(2)(ii)(J) 5. 23 CFR 490.107(b)(3)(ii)(I) 6. 23 CFR 490.107(c)(4) 7. 23 CFR 490.109(d)(1)(v) 8. 23 CFR 490.109(f)(1)(v) 9. 23 CFR 490.503(a)(2) E:\FR\FM\28SER1.SGM 28SER1 45180 Federal Register / Vol. 82, No. 187 / Thursday, September 28, 2017 / Rules and Regulations 10. 23 CFR 490.505 (Definition of Greenhouse gas (GHG)) 11. 23 CFR 490.507(b) 12. 23 CFR 490.509(f) 13. 23 CFR 490.509(g) 14. 23 CFR 490.509(h) 15. 23 CFR 490.511(a)(2) 16. 23 CFR 490.511(c) 17. 23 CFR 490.511(d) 18. 23 CFR 490.511(f) 19. 23 CFR 490.513(d). The FHWA recognizes that there are short timeframes to comply with the October 1, 2018 reporting deadline. However, FHWA expects that the burden to comply with the upcoming reporting deadline will be minimal, consisting mostly of preliminary targetsetting activities using existing data sources. The FHWA has initiated additional rulemaking procedures proposing to repeal the GHG measure (RIN 2125– AF76) and anticipates publishing an NPRM in 2017 with a goal of issuing a Final Rule in Spring 2018. jstallworth on DSKBBY8HB2PROD with RULES Waiver of Rulemaking Under the Administrative Procedure Act (APA) (5 U.S.C. 553), FHWA generally offers interested parties the opportunity to comment on proposed regulations and publishes rules not less than 30 days before their effective dates. However, the APA provides that an agency is not required to conduct notice-and-comment rulemaking or delay effective dates when the agency, for good cause, finds that the requirement is impracticable, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(B) and (d)(3)). There is good cause to waive these requirements here as unnecessary, because this rule merely ceases the suspension of the Final Rule pending additional rulemaking, as provided for in the May 19, 2017 document at 82 FR 22879, thus putting in effect the requirements of the above-referenced sections of the Final Rule as previously promulgated after notice and comment. The cessation of the suspension is therefore not significant in nature and impact, and does not impose new burdens on State departments of transportation and Metropolitan Planning Organizations. List of Subjects in 23 CFR Part 490 Bridges, Highway safety, Highways and roads, Incorporation by reference, Reporting and recordkeeping requirements. VerDate Sep<11>2014 14:07 Sep 27, 2017 Jkt 241001 Issued on: September 22, 2017. Brandye L. Hendrickson, Acting Administrator, Federal Highway Administration. [FR Doc. 2017–20804 Filed 9–25–17; 4:15 pm] BILLING CODE 4910–22–P EQUAL EMPLOYMENT OPPORTUNITY COMMISSION 29 CFR Part 1610 RIN 3046–AA90 Availability of Records Equal Employment Opportunity Commission. ACTION: Final rule. AGENCY: The Equal Employment Opportunity Commission (‘‘EEOC’’ or ‘‘Commission’’) is issuing a final rule revising its Freedom of Information Act (FOIA) regulations in order to implement the substantive and procedural changes to the FOIA identified in the FOIA Improvement Act of 2016 and update two district office addresses and the Office of Legal Counsel’s fax number. DATES: Effective September 28, 2017. FOR FURTHER INFORMATION CONTACT: Stephanie D. Garner, Assistant Legal Counsel, FOIA Programs, or Draga G. Anthony, Senior Attorney Advisor, Office of Legal Counsel, U.S. Equal Employment Opportunity Commission, at (202) 663–4640 (voice) or (202) 663– 7026 (TTY). These are not toll-free telephone numbers. This final rule also is available in the following formats: Large print, Braille, audiotape, and electronic file on computer disk. Requests for this final rule in an alternative format should be made to EEOC’s Publications Center at 1–800– 669–3362 (voice) or 1–800–800–3302 (TTY). SUMMARY: SUPPLEMENTARY INFORMATION: Introduction On December 29, 2016, EEOC published in the Federal Register an interim final rule setting forth revisions to EEOC’s FOIA regulations at 29 CFR part 1610. 81 FR 95869 (2016). The purpose of the revisions is to update the Commission’s FOIA regulations so that they are consistent with current Commission practice in responding to FOIA requests as reflected in the FOIA Improvement Act of 2016. The revisions also are intended to update two district office addresses and the Office of Legal Counsel’s fax number. The interim final rule sought public comments which were due on or before January 30, 2017. PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 EEOC received four comments in response to the interim final rule. Two comments were submitted by an individual, and the remaining two comments were submitted by the National Archives and Records Administration’s Office of Government Information Services (hereinafter ‘‘OGIS’’). The individual commenter suggested that EEOC reconsider the fifteen cent per page duplication fee charged for copies. This comment is outside the scope of the interim final rule, which did not propose changes to the duplication fees associated with processing FOIA requests. Therefore, the EEOC declines to change the duplication fees. The second comment asked the EEOC to remove the word ‘‘professional’’ in 1610.9(f)(3), which identifies the requirements of a requester seeking expedited processing. Congress strongly favors uniform FOIA regulations. The Office of Information Policy, to assist agencies in issuing uniform regulations, provided a template for agencies to utilize when revising FOIA regulations. In order to conform with the Office of Information Policy template language, the EEOC declines to remove the word ‘‘professional.’’ The Commission has considered carefully the comments from OGIS and has made some changes to the final rule in response to them. The OGIS comments concerning Sections 1610.11 and 1610.13 and EEOC’s changes to the final rule are discussed in more detail below. Section 1610.2—Statutory Requirements The EEOC determined that the final two sentences of Section 1610.2(a) of the Draft Final Rule should be deleted. Those sentences read as follows: ‘‘As a matter of policy, the Commission may make discretionary disclosures of records or information exempt from disclosure under the FOIA whenever disclosure would not foreseeably harm an interest protected by the FOIA exemption. This policy does not create any right enforceable in Court.’’ The final rule now more closely aligns with the statutory language at 5 U.S.C. 552(a)(8). The FOIA Improvement Act of 2016 codified the foreseeable harm standard; therefore, release of the records is no longer a matter of agency policy. Records must be released unless there is a risk of foreseeable harm. Section 1610.5—Request for Records Section 1610.5(a)(2), of the interim final rule said that ‘‘(2)A requester who is making a request for records about himself or herself must comply with the E:\FR\FM\28SER1.SGM 28SER1 The Administrator, Gina McCarthy, signed the final rule on December 15, 2016, and EPA is submitting it for publication in the Federal Register (FR). While we have taken steps to ensure the accuracy of this Internet version of the rule, it is not the official version of the rule for purposes of compliance. Please refer to the official version in a forthcoming FR publication, which will appear on the Government Printing Office's FDsys website (http://fdsys.gpo.gov/fdsys/search/home.action) and on Regulations.gov (http://www.regulations.gov) in Docket No. EPA-HQ-OW-2014-0693. This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 403 and 441 [EPA-HQ-OW-2014-0693; FRL-XXXX-XX-OW] RIN 2040-AF26 Effluent Limitations Guidelines and Standards for the Dental Category AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: The Environmental Protection Agency (EPA) is promulgating technology-based pretreatment standards under the Clean Water Act to reduce discharges of mercury from dental offices into municipal sewage treatment plants known as publicly owned treatment works (POTWs). Mercury is a potent neurotoxin that bioaccumulates in fish and shellfish, and mercury pollution is widespread and a global concern that originates from many diverse sources such as air deposition from municipal and industrial incinerators and combustion of fossil fuels. Dental offices, which discharge mercury present in amalgam used for fillings, are the main source of mercury discharges to POTWs; most of this mercury is subsequently released to the environment. Removing mercury when it is in a concentrated and easy to manage form in dental amalgam, before it becomes diluted and difficult and costly to remove, is a common sense step to prevent mercury from being released into the environment where it can become a hazard to humans. This final rule requires dental offices to use amalgam separators and two best management practices recommended by the American Dental Association (ADA). Amalgam Page 2 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. separators are a practical, affordable and readily available technology for capturing mercury at dental offices. The mercury collected by these separators can be recycled. This final rule includes a provision to significantly reduce and streamline the oversight and reporting requirements in EPA’s General Pretreatment Regulations that would otherwise apply as a result of this rulemaking. EPA expects compliance with this final rule will annually reduce the discharge of mercury by 5.1 tons as well as 5.3 tons of other metals found in waste dental amalgam to POTWs. DATES: The final rule is effective on [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of [insert date 30 days after publication in the Federal Register]. The compliance date, meaning the date that existing sources subject to the rule must comply with the standards in this rule is [INSERT DATE 3 YEARS AFTER EFFECTIVE DATE OF THE FINAL RULE]. After the effective date of the rule, new sources subject to this rule must comply immediately with the standards in this rule. In accordance with 40 CFR part 23, this regulation shall be considered issued for purposes of judicial review at 1 p.m. Eastern time on [INSERT DATE 14 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Under section 509(b)(1) of the CWA, judicial review of this regulation can be had only by filing a petition for review in the U.S. Court of Appeals within 120 days after the regulation is considered issued for purposes of judicial review. Under section 509(b)(2), the requirements in this regulation may not be challenged later in civil or criminal proceedings brought by EPA to enforce these requirements. ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA-HQ-OW2014-0693. All documents in the docket are listed on the https://www.regulations.gov web site. Page 3 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. This material can be viewed at the Water Docket in the EPA Docket Center, EPA/DC, EPA West William Jefferson Clinton Bldg., Room 3334, 1301 Constitution Ave., NW, Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading room is 202-566-1744, and the telephone number for the Water Docket is 202-566-2426. Publicly available docket materials are available electronically through http://www.regulations.gov. A detailed record index, organized by subject, is available on EPA’s website at https://www.epa.gov/eg/dentaleffluent-guidelines. FOR FURTHER INFORMATION CONTACT: For more information, see EPA’s website: https://www.epa.gov/eg/dental-effluent-guidelines. For technical information, contact Ms. Karen Milam, Engineering and Analysis Division (4303T), Office of Water, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone: 202-566-1915; e-mail: milam.karen@epa.gov. SUPPLEMENTARY INFORMATION: I. Regulated Entities and Supporting Information A. Regulated Entities B. Supporting Information II. Legal Authority III. Executive Summary IV. Background Page 4 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. A. Legal Framework 1. Clean Water Act 2. Effluent Limitations Guidelines and Standards a. Best Available Technology Economically Achievable (BAT) b. Best Available Demonstrated Control Technology (BADCT)/New Source Performance Standards (NSPS) c. Pretreatment Standards for Existing Sources (PSES) d. Pretreatment Standards for New Sources (PSNS) e. Best Management Practices (BMPs) B. Dental Sector Rulemaking History and Summary of Public Comments C. Existing State and Local Program Requirements D. Roles and Responsibilities under the National Pretreatment Program E. Minamata Convention on Mercury V. Description of Dental Industry & Dental Amalgam Wastewater Sources and Management A. Dental Industry B. Dental Amalgam Wastewater Sources and Management 1. Amalgam Separators 2. Polishing to Remove Dissolved Mercury from Wastewater 3. Wastewater Retention Tanks 4. Best Management Practices VI. Final Rule A. Scope and General Applicability Page 5 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. B. Existing Source (PSES) Option Selection C. New Source (PSNS) Option Selection D. Requirements 1. Performance Standard 2. Applicability to Dental Offices that Do Not Place or Remove Dental Amalgam 3. Dental Discharger Reporting and On-Site Paperwork Compliance Requirements 4. Control Authority Oversight/Reporting 5. Interaction with Existing State and Local Mandatory Dental Amalgam Reduction Programs 6. Variances E. Pollutants of Concern and Pass-Through Analysis VII. Technology Costs A. Costs for Model Dental Offices B. Costs for Larger Institutional Dental Offices VIII. Pollutant Loads A. National Estimate of Annual Pollutant Reductions to POTWs Associated with this Rule 1. Mercury 2. Other Metals 3. Total Reductions B. National Estimate of Annual Pollutant Reductions to Surface Waters Associated with this Rule IX. Economic Impact Analysis A. Social Cost Estimates Page 6 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. B. Economic Impact 1. Cost-to-Revenue Analysis 2. Ratio of Rule’s Capital Costs to Total Dental Office Capital Assets 3. Comparison of the Rule’s Capital Costs to Annual Dental Office Capital Replacement Costs C. Economic Achievability X. Cost Effectiveness Analysis XI. Environmental Assessment A. Environmental Impacts B. Environmental Benefits XII. Non-Water Quality Environmental Impacts Associated with the Technology Basis of the Rule A. Energy Requirements B. Air Emissions C. Solid Waste Generation XIII. Standards Incorporated by Reference XIV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism Page 7 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks H. Executive Order 13211: Energy Effects I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act I. Regulated Entities and Supporting Information A. Regulated Entities Entities potentially regulated by this action include: Category Example of Regulated Entity Industry A general dentistry practice or large dental facility North American Industry Classification System (NAICS) Code 621210 This section is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated or affected by this final rule. Other types of entities that do not meet the above criteria could also be regulated. To determine whether your facility would be regulated by this final rule, you should carefully examine the applicability criteria listed in section 441.10 and the definitions in section 441.20 of this final rule and detailed further in Section VI of this preamble. If you still have questions regarding the applicability of this final rule to a particular entity, consult the person listed for technical information in the preceding FOR FURTHER INFORMATION CONTACT section. B. Supporting Information Page 8 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. This final rule is supported by a number of documents including the Technical and Economic Development Document for the Final Effluent Limitations Guidelines and Standards for the Dental Category (TEDD), Document No. EPA-821-R-16-005. The TEDD and additional records are available in the public record for this final rule and on EPA’s website at https://www.epa.gov/eg/dental-effluent-guidelines. II. Legal Authority EPA promulgates this regulation under the authorities of sections 101, 301, 304, 306, 307, 308, and 501 of the CWA, 33 U.S.C. 1251, 1311, 1314, 1316, 1317, 1318, 1342 and 1361 and pursuant to the Pollution Prevention Act of 1990, 42 U.S.C. 13101 et seq. III. Executive Summary The purpose of this final rule is to set a uniform national standard that will greatly reduce the discharge of mercury-containing dental amalgam to municipal sewage treatment plants, known as POTWs, in the United States. Across the U.S., 12 states and at least 18 localities have established mandatory programs to reduce discharges of mercury to POTWs. As a result of these efforts, along with outreach from the ADA to promote voluntary actions to reduce such discharges, approximately 40 percent of the dentists subject to this rule already have installed amalgam separators. Amalgam separators greatly reduce the discharge of mercury-containing amalgam to POTWs. This rule will ensure that mercury discharges to POTWs are effectively controlled at dental offices that discharge wastewater to POTWs. Many studies have been conducted in an attempt to identify the sources of mercury entering POTWs. According to the 2002 Mercury Source Control and Pollution Prevention Program Evaluation Final Report (DCN DA00006) prepared by the Association of Metropolitan Sewerage Agencies (AMSA), dental offices are the main source of mercury discharges to Page 9 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. POTWs. A study funded by the ADA published in 2005 estimated that dental offices contributed 50 percent of mercury entering POTWs (DCN DA00163). Mercury is discharged in the form of waste dental amalgam when dentists remove old amalgam fillings from cavities, and from excess amalgam waste when a dentist places a new amalgam filling. While dental offices are not a major contributor of mercury to the environment generally, dental offices are the main source of mercury discharges to POTWs. EPA estimates that across the United States 5.1 tons of mercury and an additional 5.3 tons of other metals found in waste dental amalgam are collectively discharged into POTWs annually. Mercury entering POTWs frequently partitions into the sludge, the solid material that remains after wastewater is treated. Mercury from waste amalgam therefore can make its way into the environment from the POTW through the incineration, landfilling, or land application of sludge or through surface water discharge. Once released into the aquatic environment, certain bacteria can change mercury into methylmercury, a highly toxic form of mercury that bioaccumulates in fish and shellfish. In the U.S., consumption of fish and shellfish is the main source of methylmercury exposure to humans. The ADA, which supported removal and recycling of mercury from wastewater discharged to POTWs in its comments on the 2014 proposed rule (See DCN EPA-HQ-OW2014-0693-0434), developed best management practices (BMPs) to facilitate this goal and shared its recommendations widely with the dental community (DCN DA00165). The ADA’s voluntary amalgam waste handling and disposal practices include the use of amalgam separators to reduce mercury discharges. In addition, some states and localities have implemented mandatory programs to reduce dental mercury discharges that include the use of amalgam separators. Page 10 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. EPA has concluded that requiring dental offices to remove mercury through relatively low-cost and readily available amalgam separators and BMPs makes sense. Capturing mercuryladen waste where it is created prevents it from being released into the environment. This final rule controls mercury discharges to POTWs by establishing a performance standard for amalgam process wastewater based on the use of amalgam separator technology. The rule also requires dental dischargers to adopt two BMPs, one which prohibits the discharge of waste (“or scrap”), and the other which prohibits the use of line cleaners that may lead to the dissolution of solid mercury when cleaning chair-side traps and vacuum lines. In addition, the rule minimizes the administrative burden on dental offices subject to the rule, as well as on federal, state, and local regulatory authorities responsible for oversight and enforcement of the new standard. Administrative burden was a concern of many of the commenters on the 2014 proposed rule and EPA has greatly reduced that burden through streamlining the administrative requirements in this final rule. When EPA establishes categorical pretreatment requirements, it triggers additional oversight and reporting requirements in EPA’s General Pretreatment Regulations. The General Pretreatment Regulations specify that Control Authorities (which are often the state or POTW) are responsible for administering and enforcing pretreatment standards, including receiving and reviewing compliance reports. While other industries subject to categorical pretreatment standards typically consist of tens to hundreds of facilities, the dental industry consists of approximately 130,000 offices. Application of the default General Pretreatment Regulation oversight and reporting requirements to such a large number of facilities would be much more challenging. Further, dental office discharges differ from other industries for which EPA has established categorical pretreatment standards. Both the volume of wastewater discharged and Page 11 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. the quantity of pollutants in the discharge on a per facility basis are significantly less than other industries for which EPA has established categorical pretreatment standards. Accordingly, this final rule exempts dental offices from the General Pretreatment Regulations’ oversight and reporting requirements associated with categorical pretreatment standards, reflecting EPA’s recognition that the otherwise-applicable regulatory framework for categorical dischargers would be unlikely to have a significant positive impact on overall compliance with the rule across the dental industry, while imposing a substantial burden on state and local regulating authorities. In order to simplify implementation and compliance for the dental offices and the regulating authorities, the final rule establishes that dental dischargers are not Significant Industrial Users (SIUs) as defined in 40 CFR part 403, and are not Categorical Industrial Users (CIUs) or “industrial users subject to categorical pretreatment standards” as those terms and variations are used in the General Pretreatment Regulations, unless designated such by the Control Authority. While this rule establishes pretreatment standards that require dental offices to reduce dental amalgam discharges, the rule does not require Control Authorities to implement the traditional suite of oversight requirements in the General Pretreatment Regulations that become applicable upon the promulgation of categorical pretreatment standards for an industrial category. This significantly reduces the reporting requirements for dental dischargers that would otherwise apply by instead requiring them to demonstrate compliance with the performance standard and BMPs through a one-time compliance report to their Control Authority. This regulatory approach also eliminates the additional oversight requirements for Control Authorities that are typically associated with SIUs, such as permitting and annual inspections of individual dental offices. It also eliminates additional reporting requirements for the Control Authorities typically associated with CIUs, such as identification of CIUs in their annual pretreatment Page 12 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. reports. At the same time, the final rule recognizes the Control Authority’s discretionary authority to treat a dental discharger as an SIU and/or CIU if, in the Control Authority’s judgement, it is necessary. EPA estimated the annual costs associated with this rule. EPA’s analysis reflects that many dental offices have already taken steps to reduce dental amalgam discharges by discontinuing the use of dental amalgam, adopting the ADA’s voluntary best practices, or by meeting existing mandatory state or local requirements. On a national basis, EPA estimates that approximately 40 percent of dental offices subject to this final rule already use amalgam separators (DCN DA00456). Of the remaining 60 percent of dental offices that do not have amalgam separators and that are subject to this final rule, EPA estimates that 20 percent do not place or remove dental amalgam (DCN DA00161). These dentists that do not place or remove dental amalgam – which correspond to 12 percent of the dental offices subject to this final rule – will incur little to no costs as a result of the rule. EPA estimates the remainder (representing 48 percent of the dental offices subject to this final rule) will incur an approximate average annual cost of $800 per office. The total annual cost of this final rule is projected to be $59 - $61 million. This final rule will produce human health and ecological benefits by reducing the estimated annual nationwide POTW discharge of dental mercury to surface water from 1,003 pounds to 11 pounds. Studies show that decreased point-source discharges of mercury to surface water have resulted in lower methylmercury concentrations in fish, and that such reductions can result in quantifiable economic benefits from improved human health and ecological conditions (DCN DA00148). While not quantified, as noted above, this rule will also reduce mercury releases to the environment associated with the incineration, landfilling, or land application of Page 13 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. POTW sludges. Instead, EPA expects all of the collected amalgam will be recycled, rather than released back into the environment. IV. Background A. Legal Framework 1. Clean Water Act Congress passed the Federal Water Pollution Control Act Amendments of 1972, also known as the Clean Water Act (CWA), to “restore and maintain the chemical, physical, and biological integrity of the Nation’s waters.” (33 U.S.C. 1251(a)). The CWA establishes a comprehensive program for protecting our nation's waters. Among its core provisions, the CWA prohibits the discharge of pollutants from a point source to waters of the U.S. except as authorized under the CWA. Under section 402 of the CWA, EPA authorizes discharges by a National Pollutant Discharge Elimination System (NPDES) permit. The CWA establishes a twopronged approach for these permits: technology-based controls that establish the floor of performance for all dischargers, and water quality-based limits where the technology-based limits are insufficient for the discharge to meet applicable water quality standards. To serve as the basis for the technology-based controls, the CWA authorizes EPA to establish national technology-based effluent limitations guidelines and new source performance standards for discharges from different categories of point sources, such as industrial, commercial, and public sources, that discharge directly into waters of the U.S. Direct dischargers (those discharging directly to surface waters) must comply with effluent limitations in NPDES permits. Technology-based effluent limitations in NPDES permits for direct dischargers are derived from effluent limitations guidelines (CWA sections 301 and 304) and new source performance standards (CWA section 306) promulgated by EPA, or based Page 14 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. on best professional judgment where EPA has not promulgated an applicable effluent guideline or new source performance standard (CWA section 402(a)(1)(B) and 40 CFR 125.3). The effluent guidelines and new source performance standards established by regulation for categories of industrial dischargers are based on the degree of control that can be achieved using various levels of pollution control technology, as specified in the Act. EPA promulgates national effluent limitations guidelines and standards of performance for major industrial categories for three classes of pollutants: (1) conventional pollutants (total suspended solids, oil and grease, biochemical oxygen demand, fecal coliform, and pH) as outlined in CWA section 304(a)(4) and 40 CFR 401.16; (2) toxic pollutants (e.g., toxic metals such as chromium, lead, mercury, nickel, and zinc) as outlined in section 307(a) of the Act, 40 CFR 401.15 and 40 CFR part 423, appendix A; and (3) non-conventional pollutants, which are those pollutants that are not categorized as conventional or toxic (e.g., ammonia-N, formaldehyde, and phosphorus). The CWA also authorizes EPA to promulgate nationally applicable pretreatment standards that restrict pollutant discharges from facilities that discharge pollutants indirectly, by sending wastewater to POTWs, as outlined in sections 307(b), (c) and 304(g) of the CWA. EPA establishes national pretreatment standards for those pollutants that may pass through, interfere with, or may otherwise be incompatible with POTW operations. CWA sections 307(b) and (c) and 304(g). The legislative history of the 1977 CWA amendments explains that pretreatment standards are technology-based and analogous to technology-based effluent limitations for direct dischargers for the removal of toxic pollutants. As further explained in the legislative history, the combination of pretreatment and treatment by the POTW is intended to achieve the level of treatment that would be required if the industrial source were making a direct discharge. Conf. Page 15 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Rep. No. 95-830, at 87 (1977), reprinted in U.S. Congress. Senate. Committee on Public Works (1978), A Legislative History of the CWA of 1977, Serial No. 95-14 at 271 (1978). As such, in establishing pretreatment standards, EPA’s consideration of pass through for national technology-based categorical pretreatment standards differs from that described in EPA’s General Pretreatment regulations at 40 C.F.R. part 403. For categorical pretreatment standards, EPA’s approach for pass through satisfies two competing objectives set by Congress: (1) That standards for indirect dischargers be equivalent to standards for direct dischargers; and (2) that the treatment capability and performance of the POTWs be recognized and taken into account in regulating the discharge of pollutants from indirect dischargers. CWA 301(b)(1)(A)(BPT); and 301(b)(1(E). 2. Effluent Limitations Guidelines and Standards EPA develops Effluent Guidelines Limitations and Standards (ELGs) that are technology-based regulations for specific categories of dischargers. EPA bases these regulations on the performance of control and treatment technologies. The legislative history of CWA section 304(b), which is the heart of the effluent guidelines program, describes the need to press toward higher levels of control through research and development of new processes, modifications, replacement of obsolete plants and processes, and other improvements in technology, taking into account the cost of controls. Congress has also stated that EPA need not consider water quality impacts on individual water bodies as the guidelines are developed; see Statement of Senator Muskie (October 4, 1972), reprinted in U.S. Senate Committee on Public Works, Legislative History of the Water Pollution Control Act Amendments of 1972, Serial No. 93-1, at 170). Page 16 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. There are standards applicable to direct dischargers (dischargers to surface waters) and standards applicable to indirect dischargers (dischargers to POTWs). The types of standards relevant to this rulemaking are summarized here. a. Best Available Technology Economically Achievable (BAT) BAT represents the second level of stringency for controlling direct discharge of toxic and nonconventional pollutants. In general, BAT-based effluent guidelines and new source performance standards represent the best available economically achievable performance of facilities in the industrial subcategory or category. Following the statutory language, EPA considers the technological availability and the economic achievability in determining what level of control represents BAT. CWA section 301(b)(2)(A). Other statutory factors that EPA considers in assessing BAT are the cost of achieving BAT effluent reductions, the age of equipment and facilities involved, the process employed, potential process changes, and nonwater quality environmental impacts, including energy requirements and such other factors as the Administrator deems appropriate. CWA section 304(b)(2)(B). The Agency retains considerable discretion in assigning the weight to be accorded these factors. Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1045 (D.C. Cir. 1978). b. Best Available Demonstrated Control Technology (BADCT)/New Source Performance Standards (NSPS) NSPS reflect effluent reductions that are achievable based on the best available demonstrated control technology (BADCT). Owners of new facilities have the opportunity to install the best and most efficient production processes and wastewater treatment technologies. As a result, NSPS should represent the most stringent controls attainable through the application of the BADCT for all pollutants (that is, conventional, nonconventional, and toxic pollutants). In Page 17 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. establishing NSPS, EPA is directed to take into consideration the cost of achieving the effluent reduction and any non-water quality environmental impacts and energy requirements. CWA section 306(b)(1)(B). c. Pretreatment Standards for Existing Sources (PSES) Pretreatment standards apply to dischargers of pollutants to POTWs; Pretreatment Standards for Existing Sources are designed to prevent the discharge of pollutants to POTWs that pass through, interfere with, or are otherwise incompatible with the operation of POTWs, including sludge disposal methods of POTWs. Categorical pretreatment standards for existing sources are technology-based and are analogous to BAT effluent limitations guidelines, and thus the Agency typically considers the same factors in promulgating PSES as it considers in promulgating BAT. See Natural Resources Defense Council v. EPA, 790 F.2d 289, 292 (3rd Cir. 1986). d. Pretreatment Standards for New Sources (PSNS) Like PSES, PSNS are designed to prevent the discharges of pollutants that pass through, interfere with, or are otherwise incompatible with the operation of POTWs. New indirect discharges have the opportunity to incorporate into their facilities the best available demonstrated technologies. In establishing pretreatment standards for new sources, the Agency typically considers the same factors in promulgating PSNS as it considers in promulgating NSPS (BADCT). e. Best Management Practices (BMPs) Section 304(e) of the CWA authorizes the Administrator to publish regulations, in addition to effluent limitations guidelines and standards for certain toxic or hazardous pollutants, “to control plant site runoff, spillage or leaks, sludge or waste disposal, and drainage from raw Page 18 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. material storage which the Administrator determines are associated with or ancillary to the industrial manufacturing or treatment process . . . and may contribute significant amounts of such pollutants to navigable waters.” In addition, section 304(g), read in concert with section 501(a), authorizes EPA to prescribe as wide a range of pretreatment requirements as the Administrator deems appropriate in order to control and prevent the discharge into navigable waters, either directly or through POTWs, any pollutant which interferes with, passes through, or otherwise is incompatible with such treatment works. (see also Citizens Coal Council v. U.S. EPA, 447 F3d 879, 895-96 (6th Cir. 2006) (upholding EPA’s use of non-numeric effluent limitations and standards); Waterkeeper Alliance, Inc. v. U.S. EPA, 399 F.3d 486, 496-97, 502 (2d Cir. 2005) (EPA use of non-numerical effluent limitations in the form of BMPs are effluent limitations under the CWA); and Natural Res. Def. Council, Inc. v. EPA, 673 F.2d 400, 403 (D.C. Cir. 1982) (“section 502(11) [of the CWA] defines ‘effluent limitation’ as ’any restriction’ on the amounts of pollutants discharged, not just a numerical restriction.”)) B. Dental Category Effluent Guidelines Rulemaking History and Summary of Public Comments EPA published the proposed rule on October 22, 2014, and took public comment through February 20, 2015. During the public comment period, EPA received approximately 200 comments. EPA also held a public hearing on November 10, 2014. Administrative burden was a concern of many of the commenters on the 2014 proposed rule, particularly from regulatory authorities responsible for oversight and enforcement of the new standard. Commenters also provided additional information on amalgam separators (e.g., costs, models, and design) as well as information on some other approaches to reduce pollutant discharges from dentists. Commenters also offered ways to improve and/or clarify the proposed pretreatment standards, Page 19 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. including the proposed numerical efficiency and operation and maintenance requirements. See DCN DA00516 for these comments and EPA’s responses. C. Existing State and Local Program Requirements Currently, 12 states (Connecticut, Louisiana 1, Maine, Massachusetts, Michigan, New Hampshire, New Jersey, New Mexico, New York, Rhode Island, Vermont, and Washington) have mandatory programs to reduce dental mercury discharges. Additionally, at least 18 localities (located in California, Colorado, Ohio, and Wisconsin) similarly have mandatory dental amalgam reduction pretreatment programs. EPA analyzed readily available information about these programs and found commonalities (DCN DA00524). For example, all require the use of amalgam separators and most specify associated operating and maintenance requirements. The majority of these programs also require some type of best management practices, and at least a one-time compliance report to the regulating authority. D. Roles and Responsibilities under the National Pretreatment Program The National Pretreatment Program requires industrial dischargers that discharge to POTWs to comply with pretreatment standards. The General Pretreatment Regulations in 40 CFR part 403 establish roles and responsibilities for entities involved in the implementation of pretreatment standards. This section summarizes the roles and responsibilities of Industrial Users (IUs), Control Authorities, and Approval Authorities. For a detailed description, see the preamble for the proposed rule (79 FR 63279-63280; October 22, 2014). 1 Louisiana state requirements do not explicitly require dental offices to install amalgam separators; dental offices must follow BMPs recommended by the ADA in 1999. ADA added amalgam separators to the list of BMPs in 2008. Page 20 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. An IU is a nondomestic source of indirect discharge into a POTW, and in this rule is the dental discharger. The Control Authority may be the POTW, the state, or EPA, depending on whether the POTW or the state is approved by EPA to administer the pretreatment program. The Control Authority is the POTW in cases where the POTW has an approved pretreatment program. The Control Authority is the state, where the POTW has not been approved to administer the pretreatment program, but the state has been approved. The Control Authority is EPA where neither the POTW nor the state have been approved to administer the pretreatment program. The Approval Authority is the State (Director) in an NPDES authorized state with an approved pretreatment program; or the EPA regional administrator in a non-NPDES authorized state or NPDES state without an approved state pretreatment program. Typically, an IU is responsible for demonstrating compliance with pretreatment standards by performing self-monitoring, submitting reports and notifications to its Control Authority, and maintaining records of activities associated with its discharge to the POTW. The Control Authority is the regulating authority responsible for implementing and enforcing pretreatment standards. The General Pretreatment Regulations require certain minimum oversight of IUs by Control Authorities. The required minimum oversight includes receipt and analysis of reports and notifications submitted by IUs, random sampling and analyzing effluent from IUs, and conducting surveillance activities to identify occasional and continuing non-compliance with pretreatment standards. The Control Authority is also responsible for taking enforcement action as necessary. For IUs that are designated as Significant Industrial Users (SIUs), Control Authorities must inspect and sample the SIU effluent annually, review the need for a slug control plan, and issue a permit or equivalent control mechanism. IUs subject to categorical pretreatment standards are referred to as Categorical Industrial Users (CIUs). The General Pretreatment Page 21 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Regulations define SIU to include CIUs. The Approval Authority is responsible for ensuring that POTWs comply with all applicable pretreatment program requirements. Among other things, the Approval Authority receives annual pretreatment reports from the Control Authority. These reports must identify which IUs are CIUs. E. Minamata Convention on Mercury On November 6, 2013, the United States joined the Minamata Convention on Mercury, a new multilateral environmental agreement that addresses specific human activities that are contributing to widespread mercury pollution. The agreement identifies dental amalgam as a mercury-added product for which certain measures should be taken. Specifically, the Convention lists nine measures for phasing down the use of mercury in dental amalgam, including promoting the use of best environmental practices in dental offices to reduce releases of mercury and mercury compounds to water and land. Nations that are parties to the Convention are required to implement at least two of the nine measures to address dental amalgam. This final rule contributes to the U.S.’s efforts to meet the measures called for in the treaty. V. Description of Dental Industry & Dental Amalgam Wastewater Sources and Management A. Dental Industry The industry category affected by this final rule is Offices of Dentists (NAICS 621210), which comprises establishments of health practitioners primarily engaged in the independent practice of general or specialized dentistry, or dental surgery. These practitioners operate individual or group practices in their own offices or in the offices of others, such as hospitals or health maintenance organization medical centers. They can provide either comprehensive preventive, cosmetic, or emergency care, or specialize in a single field of dentistry. Page 22 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. According to the 2012 Economic Census, there are 133,221 U.S. dental offices owned or operated by 125,275 dental firms. 2 Only 2 percent of all dental firms are multi-unit, the rest are single-unit. The growth of the number of dental offices remained steady over the past decade with an average increase of 1 percent per year. The industry includes mostly small businesses with an estimated over 99 percent of all offices falling below the Small Business Administration (SBA) size standard ($7.5 million in annual revenue). Using Census Bureau data, EPA estimates an average revenue for offices at $787,190 per year with an average of 6.6 employees per establishment. According to ADA data, approximately 80 percent of the dental industry engages in general dentistry. Approximately 20 percent are specialty dentists such as periodontists, orthodontists, radiologists, maxillofacial surgeons, endodontists, or prosthodontists (DCN DA00460). Dentistry may also be performed at larger institutional dental offices (military clinics and dental schools). Since EPA does not know if these offices are included in the 2012 Economic Census data, EPA conservatively assumed the largest offices are not present in the data, and so added an estimate of 415 larger institutional dental offices across the nation. For the final rule, EPA updated this number based on comments received on the proposed rule. B. Dental Amalgam Wastewater Sources and Management Dental amalgam consists of approximately 49 percent mercury by weight. Mercury is the only metal that is in its liquid phase at room temperature, and it bonds well with powdered alloy. 2 A firm is a business organization, such as a sole proprietorship, partnership, or corporation. Page 23 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. This contributes to its durability in dental amalgam. The other half of dental amalgam is usually composed of 35 percent silver, 9 percent tin, 6 percent copper, 1 percent zinc and small amounts of indium and palladium (DCN DA00131). Sources of dental amalgam discharges generally occur in the course of two categories of activities. The first category of discharges may occur in the course of treating a patient, such as during the placement or removal of a filling. When filling a cavity, dentists overfill the tooth cavity so that the filling can be carved to the proper shape. The excess amalgam is typically rinsed into a cuspidor, or suctioned out of the patient’s mouth. In addition to filling new cavities, dentists also remove old restorations that are worn or damaged. Removed restorations also may be rinsed into a cuspidor or suctioned out of the patient’s mouth. Based on information in the record (DCN DA00456), removed restorations is the largest contributor of mercury in dental discharges. The second category of dental amalgam discharges occurs in the course of activities not directly involved with the placement or removal of dental amalgam. Preparation of dental amalgam, disposing of excess amalgam, and flushing vacuum lines with corrosive chemicals present opportunities for dental amalgam to be discharged. The use of dental amalgam has decreased steadily since the late 1970s as alternative materials such as composite resins and glass ionomers have become more widely available. Estimates show that placements of dental amalgam have decreased on average by about 2 to 3% per year (74 FR 38686); August 4, 2009). Based on this information, EPA estimates that mercury in dental amalgam discharges to POTWs will decrease by about half within the next 25 years. While the use of dental amalgam continues to decline, EPA estimates that approximately 2 tons of mercury would continue to be discharged to POTWs in 2040. Page 24 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. The typical plumbing configuration in a dental office consists of a chair-side trap for each chair, and a central vacuum pump with a vacuum pump filter. Chair-side traps and vacuum pump filters remove approximately 78 percent of dental amalgam particles from the wastewater stream (DCN DA00163). EPA identified three major technologies that capture dental amalgam waste, in addition to chair-side traps and vacuum pump filters, before it is discharged to the POTW: separators, ion exchange, and wastewater containment systems. EPA also identified BMPs that have a significant impact on dental amalgam discharges. 1. Amalgam Separators An amalgam separator is a device designed to remove solids from dental office wastewater. Amalgam separators remove amalgam particles from the wastewater through centrifugation, sedimentation, filtration, or a combination of any of these methods. Practically all amalgam separators on the market today rely on sedimentation because of its effectiveness and operational simplicity. The vast majority of amalgam separators on the market today have been evaluated for their ability to meet the current American National Standards Institute’s (ANSI) Standard for Amalgam Separators (ANSI/ADA Standard No. 108 for Amalgam Separators). This standard incorporates the International Organization for Standardization (ISO) Standard for Dental Amalgam Separators Page 25 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. (http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=42288). 3 The current ISO standard for amalgam separators is ISO 11143. ISO established a standard for measuring amalgam separator efficiency by evaluating the retention of amalgam solids using specified test procedures in a laboratory setting. In order to meet the ISO standard, a separator must achieve 95 percent removal or greater of total solids. The ISO standard also includes certain design requirements and requirements for instructions for proper use and maintenance. For example, for non-sedimentation amalgam separators, the ISO 11143 standard requires a warning system such as an auditory or visual sign to indicate when the separator’s efficiency is compromised to ensure that the operator is aware that the separator is not operating optimally. For sedimentation separators, the requirement can be met by providing instructions that would allow the operator to ascertain the operating status of the amalgam separator. Based on reported removal efficiencies of a range of amalgam separators currently on the market that meet the ISO standard, separators obtain a median of 99 percent removal efficiency (see Chapter 7 of the TEDD) of total dental solids. When existing chair-side traps and vacuum pump filters are used upstream of the amalgam separators, the combined treatment system can achieve total mercury removal rates exceeding 99 percent (DCN DA00008). 3 ANSI is the coordinator of the U.S. voluntary consensus standards system. An ISO document may be nationally adopted as an ANS as written or with modifications to its content that reflect technical deviations to the ISO standard that have been agreed upon through a consensus process. In other words, a consensus of U.S. experts, in an open and due process based environment, agreed that ISO 11143 with U.S. modifications is appropriate for adoption as an ANS. Page 26 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Solids collected by the amalgam separator may be a combination of dental amalgam, biological material from patients, and any other solid material sent down the vacuum line. The collected solids must be handled in accordance with federal, state and local requirements. EPA regulates the disposal of mercury-containing hazardous waste under the Resource Conservation and Recovery Act (RCRA). A mercury-containing waste can be considered hazardous in two ways: (1) as a listed hazardous waste; or (2) as a characteristic hazardous waste. Unused elemental mercury being discarded would be a listed hazardous waste (waste code U151). Persons who generate hazardous waste, such as a waste that exhibits the hazardous characteristics for mercury, are subject to specific requirements for the proper management and disposal of that waste. The federal RCRA regulatory requirements differ depending upon how much hazardous waste a site generates per month. Most dental practices generate less than 100 kilograms of non-acute hazardous waste per month and less than 1 kilogram of acute hazardous waste per month. Such facilities are therefore classified as “Very Small Quantity Generators” (VSQGs). VSQGs are not subject to most of the RCRA hazardous waste requirements. Many states have additional requirements for the handling of mercury, including waste dental amalgam. Chapter 6 of the TEDD provides additional details on the handling requirements for states that require dentists to control dental mercury dischargers. To facilitate compliance with state and local requirements, several amalgam separator manufacturers offer services that facilitate the transport of waste amalgam to facilities that separate mercury from other metals in dental amalgam and recycle the mercury, keeping it out of the environment. EPA recommends that dental dischargers take advantage of such services. In 2012, ADA posted a directory of amalgam recyclers on its website. See DCN DA00468. Page 27 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. For more information about amalgam separators, see the proposed rule (79 FR 63265; October 22, 2014). 2. Polishing to Remove Dissolved Mercury from Wastewater Mercury from dental amalgam in wastewater is present in both the particulate and dissolved form. The vast majority (>99.6 percent) is particulate (DCN DA00018). An additional process sometimes referred to as “polishing” uses ion exchange to remove dissolved mercury from wastewater. Dissolved mercury has a tendency to bind with other chemicals, resulting in a charged complex. Ion exchange is the process that separates these charged amalgam particles from the wastewater. For ion exchange to be most effective, the incoming wastewater must first be treated to remove solids. Then the wastewater needs to be oxidized (creating a charge on the amalgam particles) in order for the resin or mercury capturing material to capture the dissolved mercury. Therefore, ion exchange will not be effective without first being preceded by a solids collector and an oxidation process. The data available to EPA indicate that total additional mercury reductions with the addition of polishing are typically about 0.5 percent (DCN DA00164). This is not surprising since, as indicated above, dissolved mercury contributes such a small portion to the total amount of mercury in wastewater. In addition to polishing as described above, EPA is aware that vendors are developing amalgam separators with an improved resin for removing dissolved mercury. For additional discussion on polishing, see proposal (79 FR 63266; October 22, 2014). 3. Wastewater Retention Tanks Commenters on the proposed rule identified wastewater retaining tanks as a third technology to reduce mercury discharges from dental offices to POTWs. Where currently used, Page 28 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. these systems collect and retain all 4amalgam process wastewater. The wastewater remains in the wastewater retention tank until it is pumped out of the tank and transferred to a privately owned wastewater treatment facility. This eliminates the discharge of amalgam process wastewater and the associated pollutants from a dental office to a POTW. 4. Best Management Practices In addition to technologies, EPA also identified best management practices currently used in this industry (and included in the ADA BMPs) to reduce dental amalgam discharges. In particular, EPA identified two BMPs to control dental amalgam discharges that would not be captured by an amalgam separator and/or polishing unit. Oxidizing line cleaners can solubilize bound mercury. If oxidizing cleaners are used to clean dental unit water lines, chair side traps, or vacuum lines that lead to an amalgam separator, the line cleaners may solubilize any mercury that the separator has captured, resulting in increased mercury discharges. One BMP ensures the efficiency of amalgam separators by prohibiting use of oxidizing line cleaners including but not limited to, bleach, chlorine, iodine and peroxide, that have a pH lower than 6 or greater than 8. 5 Flushing waste amalgam from chair-side traps, screens, vacuum pump filters, dental tools, or collection devices into drains also presents additional opportunities for mercury to be 4 Dental offices using wastewater retention tanks must ensure that all amalgam process wastewater is collected by the wastewater retention tanks. Any uncollected amalgam process wastewater that is discharged to the POTW is subject to this rule. 5 Many alternatives use enzymatic or other processes that do not lead to the dissolution of mercury when used to clean chairside traps, and vacuum lines. See DCN DA00215. Page 29 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. discharged from the dental office. The second BMP prohibits flushing waste dental amalgam into any drain. VI. Final Rule A. Scope and General Applicability Consistent with the proposal, dental offices that discharge to POTWs are within the scope of this final pretreatment rule. 6 EPA solicited information in the proposal from the public on its preliminary finding that, with few exceptions, dental offices do not discharge wastewater directly to surface waters. EPA did not receive any comments containing data to contradict this finding. Therefore, EPA is not establishing any requirements for direct wastewater discharges from dental offices to surface waters at this time. The final rule applies to wastewater discharges to POTWs from offices where the practice of dentistry is performed, including large institutions such as dental schools and clinics; permanent or temporary offices, home offices, and facilities; and including dental offices owned and operated by federal, state, or local governments including military bases. The final rule does not apply to wastewater discharges from dental offices where the practice of dentistry consists exclusively of one or more of the following dental specialties: oral pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, periodontics, or prosthodontics. As described in the TEDD, these specialty practices are not expected to engage in the practice of amalgam restorations or removals, and are not expected to have any wastewater discharges containing dental amalgam. 6 The final rule does not apply to dental discharges to septic systems. Page 30 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. The final rule also does not apply to wastewater discharges to POTWs from mobile units. EPA proposed to apply the standards to mobile units (typically a specialized mobile selfcontained van, trailer, or equipment from which dentists provide services at multiple locations), soliciting comments and data pertaining to them (79 FR 63261; October 22, 2014). However, EPA is not establishing requirements for mobile units at this time because it has insufficient data to do so. EPA does not have, nor did commenters provide, data on the number, size, operation, or financial characteristics of mobile units. EPA also has minimal information on wastewater discharges from mobile units, and/or practices employed to minimize dental amalgam in such discharges. Therefore, any further evaluation of requirements for mobile units is not possible at this time, and the final rule requirements do not apply to mobile units. B. Existing Source (PSES) Option Selection After considering all of the relevant factors and dental amalgam management approaches discussed in this preamble and TEDD, as well as public comments, EPA decided to establish PSES based on proper operation and maintenance of one or more ISO 11143 7 compliant amalgam separators and two BMPs – a prohibition on the discharge of waste (or “scrap”) amalgam to POTWs and a prohibition on the use of line cleaners that are oxidizing or acidic and that have a pH higher than 8 or lower than 6. EPA finds that the technology basis is “available” as that term is used in the CWA because it is readily available and feasible for all dental offices subject to this rule. Data in the record demonstrate that the technology basis is extremely effective in reducing pollutant discharges in dental wastewater to POTWs as the median efficacy 7 ISO 11143 Standard as incorporated and updated by ANSI Standard 108 (ANSI 108/ISO 11143 Standard) Page 31 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. of ISO compliant amalgam separators on the market in the U.S. is 99.3 percent. Moreover, ADA recommends that dentists use the technology on which this rule is based (ISO compliant amalgam separators and BMPs). Further, as described in Section III, EPA estimates that approximately 40 percent of dental offices potentially subject to this rule currently use amalgam separators on a voluntary basis or are in states or localities with laws requiring the use of amalgam separators. Many dentists have used amalgam separators and BMPs for at least a decade. For those dental offices that have not yet installed an amalgam separator, EPA estimates this is a low-cost technology with an approximate average annual cost of $800 8 per office. EPA’s economic analysis shows that this rule is economically achievable (see Section IX). Finally, EPA also examined the incremental non-water-quality environmental impacts of the final pretreatment standards and found them to be acceptable. See Section XII. EPA did not establish PSES based on technologies that remove dissolved mercury such as polishing. EPA is not aware of any state or local regulations that require ion exchange or that require removal of dissolved mercury. Commenters raised operational concerns with ion exchange citing a pilot study for the department of Navy. EPA also lacks adequate performance data to assess the efficacy of polishing for nationwide use. While even very small amounts of mercury have environmental effects, EPA lacks sufficient data to conclude that there is a significant difference in the performance between traditional amalgam separators and polishing. Moreover, current information suggests that polishing is not available for nationwide use 8 This estimate is based on the average annualized cost for dental offices that do not currently have an amalgam separator. See DCN DA00458. Page 32 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. because the typical dental office may not have adequate space to install the treatment train needed for effective polishing and because there are few polishing systems on the market today in comparison to traditional amalgam separators. Lastly, EPA estimates that the capital costs of the polishing system, as a stand-alone system, are approximately four times that of the amalgam separator even though the costs for chemical use, regenerating the resin, filter replacement, and other operational costs were not reported (DCN DA00122). These factors led EPA to find that polishing is not ‘‘available’’ as that term is used in the CWA. EPA also did not establish PSES based on wastewater retention tanks. Capital costs for wastewater retention tanks are approximately twice that of the amalgam separator (DCN DA00461). EPA does not have information on the costs incurred by the dental office to send the collected wastewater off-site to a privately owned treatment facility (may also be referred to as a centralized waste treatment facility or CWT). Furthermore, wastewater retention tanks require space, and EPA determined that the typical dental office may not have adequate space to install the tanks. In addition, EPA is only aware of one vendor currently offering this technology and service combination (vendor transfers the collected wastewater to a privately owned treatment facility), and the vendor’s service area is limited to a few states. Therefore, EPA did not find this technology to be available to the industry as a whole. C. New Source (PSNS) Option Selection After considering all of the relevant factors and technology options discussed in this preamble and in the TEDD, as well as public comments, EPA decided to establish PSNS based on the same technologies identified above as PSES. As previously noted, under section 307(c) of the CWA, new sources of pollutants into POTWs must comply with standards that reflect the greatest degree of effluent reduction achievable through application of the best available Page 33 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. demonstrated control technologies. Congress envisioned that new treatment systems could meet tighter controls than existing sources because of the opportunity to incorporate the most efficient processes and treatment systems into the facility design. The technologies used to control pollutants at existing offices, amalgam separators and BMPs, are fully available to new offices. In addition, data from EPA’s record show that the incremental cost of an amalgam separator compared to the cost of opening a new dental office is negligible; therefore, EPA determined that the final PSNS present no barrier to entry (see Section IX below). Similarly, because EPA projects that the incremental non-water quality environmental impacts associated with controls for new sources would not exceed those for existing sources, EPA concludes the non-water quality environmental impacts are acceptable. Therefore, this final rule establishes PSNS that are the same as those for PSES. EPA rejected other technologies as the basis for PSNS for the same reasons the Agency rejected other technology bases for PSES. D. Requirements 1. Performance Standard EPA finalized the performance standards based on the same technology identified in the proposed rule, amalgam separators. EPA proposed a standard that would require dental dischargers to remove a specified percentage of total mercury from amalgam process wastewater and to follow the BMPs. Recognizing the impracticality of collecting and analyzing wastewater samples to demonstrate compliance with the standard for this industry, EPA included a provision by which dental offices could demonstrate compliance by certifying they were following the required BMPs and using an amalgam separator that achieved the specified percentage when tested for conformance with Page 34 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. the ISO standard. EPA received comments regarding the proposed requirement. Commenters questioned the specified percent reduction, and raised concerns that the proposed standard could require dental offices to measure the percent removal being achieved by their amalgam separator, which was not the Agency’s intent. In response to these comments, the final rule specifies a performance standard – BMPs and the use of an amalgam separator(s) compliant with the ISO standard rather than specifying a numerical reduction requirement. The final rule also includes a provision such that the performance standard can be met with the use of an amalgam removing technology other than an amalgam separator (equivalent device). EPA included this provision to incorporate future technologies that achieve comparable removals of pollutants from dental discharges as amalgam separators but that may not fall under the amalgam separator classification. Because the rule does not include a numerical limit, the performance standards also specify certain operation and maintenance requirements for the amalgam separator or comparable device to ensure they are operated optimally. The final rule allows dental offices to continue to operate existing amalgam separators for their lifetime or ten years (whichever comes first), as long as the dental discharger complies with the other rule requirements including the specified BMPs, operation and maintenance, reporting, and recordkeeping requirements. Once the separator needs to be replaced or the ten-year period has ended, dental offices will need to replace the amalgam separator with one that meets the requirements of the final rule. EPA does not want to penalize existing dental offices or institutional dental offices that have already installed amalgam separators voluntarily or to comply with state or local requirements. EPA recognizes that these offices may currently have amalgam separators in place that do not meet the ANSI ADA specification or the criteria of the ISO 11143 2008 standard. EPA did not want to establish a rule that would require dental offices Page 35 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. with existing separators that still have a remaining useful life to be retrofitted with new separators, both because of the additional costs incurred by dental offices that adopted technology to reduce mercury discharges ahead of EPA’s requirements and because of the additional solid waste that would be generated by disposal of the existing separators. In addition to installing one or more amalgam separators compliant with the ISO 11143 standard (or its equivalent) and implementing the required BMPs, the pretreatment standards specify certain operating and maintenance requirements for the amalgam separator. For example, the final rule requires a documented amalgam separator inspection to ensure the separator is performing properly. As explained in Section V, malfunctioning separators or separators that have reached their capacity are ineffective. Therefore, in order to ensure that mercury is not discharged from the facility, it is important that dentists know the operational status of their amalgam separator (see 40 CFR 441.40(c)). As such, the final rule requires the separator to be inspected per the manufacturer’s instructions. In addition, as explained in Section V, the ISO standard specifies non-sedimentation separators must have a visual or auditory warning indicator when the separator is nearly full or operating in by-pass mode. While not required for sedimentation amalgam separators, some manufacturers of sedimentation amalgam separators include visual or auditory warning indicators. Because warning indicators make it easy to detect when the separator is not operating optimally, EPA encourages dental offices to select an amalgam separator with a warning indicator when installing a new amalgam separator. EPA is aware that some amalgam separator vendors (in addition to providing the needed equipment) or service providers offer service contracts to maintain the system. These vendors also typically provide waste management services for the collected solids. Some vendors also provide the necessary documentation and reports required by existing state and local programs. Page 36 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. EPA encourages but does not require dental offices to consider such services, as they may aid compliance with the rule. 2. Applicability to Dental Offices That Do Not Place or Remove Dental Amalgam In the final rule, dental dischargers that do not place dental amalgam, and do not remove dental amalgam except in limited emergency or unplanned, unanticipated circumstances are exempt from any further requirements as long as they certify such in their One-time Compliance Report to their Control Authority. In this way, if, over time, the use of dental amalgam is phased out as a restorative material, the requirements of this rule will no longer apply. By limited circumstances, EPA means, dental offices that remove amalgam at a frequency less than five percent of its procedures. As described below, based on the record, on average, this percent approximates to 9 removals per office per year (DCN DA00467). Dental amalgam traditionally has been used as a restorative material for cavities because the malleability of newly mixed amalgam makes it easy to place into cavities and because of its durability over time. While still used in many dental offices in the U.S., some dental offices have elected not to use dental amalgam and instead use only non-mercury based filling materials, such as composite resins and glass ionomer cements (DCN DA00495). As explained in Section IV, removed restorations are the largest contributor of mercury in dental discharges. Some dental offices have also elected not to remove amalgam restorations. EPA recognizes some dental offices only remove dental amalgam extremely infrequently, where there is an unplanned, unanticipated procedure. At the same time, for accepting new patients during the normal course of business, EPA would expect offices to inquire as to whether the patient has mercury fillings and not accept patients that have such fillings unless they install a separator or equivalent treatment in accordance with this rule. EPA proposed that dental offices Page 37 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. that certify that they do not place or remove amalgam except in limited emergency circumstances would be exempt from any further requirements of the rule. EPA is clarifying in the final rule that the limited circumstances provision applies to the removal, but not to the placement of dental amalgam. A dental office that stocks amalgam capsules clearly intends to place amalgam, and does not represent the type of limited circumstance this provision is intended to address. Commenters largely supported this approach, and most commenters suggested EPA define limited emergency circumstances. The frequency recommended by these commenters ranged from once a quarter to 96 times a year (DCN DA00467). EPA is including the limited circumstances provision in the final rule to allow a dental office that does not reasonably expect to place or remove dental amalgam to provide immediate treatment, such as where unplanned, unanticipated removal of the amalgam is necessary at that facility at that time, in the professional judgment of the dentist. EPA’s intent is to exclude dental offices from the rule’s requirements, other than a one-time report, for unplanned removals. In EPA's view, dental offices that remove amalgam at a frequency more often than five percent of its procedures are not likely engaging in only limited, unplanned removals. EPA estimates that on average, a single chair dental office would remove amalgam 183 times per year (DCN DA00467). An amalgam removal rate that represents less than five percent of this frequency consists of approximately nine removals per year, on average, respectively. However, because EPA does not have, nor did commenters provide, data on the frequency of such unplanned and unanticipated instances nationwide, the final rule does not include a specific definition of limited circumstances. Rather, EPA expects a dental office to carefully consider its operation in light of the information provided above and only certify accordingly to their Control Authority if it meets the situation EPA described. Page 38 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. 3. Dental Discharger Reporting and On-Site Paperwork Compliance Requirements Dental dischargers subject to this rule must comply with a one-time reporting requirement specified in the final rule in lieu of the otherwise applicable reporting requirements in 40 CFR part 403. Submission of reports as specified in this rule satisfies the reporting requirements in 40 CFR parts 403 and 441. For dental offices that do not place or remove dental amalgam except in limited circumstances, dental offices must submit a One-Time Compliance Report that includes information on the facility and a certification statement that the dental discharger does not place dental amalgam and does not remove amalgam except in limited circumstances. For dental offices that place or remove dental amalgam, the One-Time Compliance Report must include information on the dental facility and its operations and a certification that the dental discharger meets the requirements of the applicable performance standard. Dentists that utilize a third party to maintain their separator must report that information in their One-Time Compliance Report. Dentists that do not utilize a third party to maintain the amalgam separator(s) must provide a description of the practices employed by the office to ensure proper operation and maintenance. EPA suggests dental offices consider use of signs displayed prominently in the office or electronic calendar alerts to remind staff of dates to perform and document monthly inspections, cartridge replacement, etc. If a dental practice changes ownership (which is a change in the responsible party, as defined in 40 CFR 403.12(l)), the new owner must submit a One-Time Compliance Report that contains the required information. The One-Time Compliance Report must be signed by (1) a responsible corporate officer if the dental office is a corporation; (2) a general partner or proprietor if the dental office is a partnership or sole proprietorship; or (3) a duly authorized representative of the responsible Page 39 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. corporate officer, or general partner or proprietor. This does not preclude a third party from submitting the report on behalf of a dental office as long as the submission also includes a proper signature as described above. The final rule does not require electronic reporting nor does it prevent electronic reporting. EPA received several comments requesting that EPA develop an electronic compliance reporting system as a part of this final rule. These commenters generally advocated for electronic reporting due to the size of the industry and the proposed annual reporting requirement. During development of the final rule, EPA considered several variations of requirements for dental dischargers to report electronically (which would have necessitated an electronic system). Most commonly, electronic systems are preferable when reports must be submitted on a periodic basis. EPA ultimately decided not to specify electronic reporting in the final rule after it determined the final rule would only require a one-time compliance report from each affected dental discharger. Still, EPA recognizes that some Control Authorities may prefer to receive the one-time reports electronically or to provide affected dental dischargers with the option to report electronically. EPA also recognizes that electronic submittal of required reports could increase the usefulness of the reports, is in keeping with current trends in compliance reporting, and could result in less burden on the regulated community and the Control Authorities. EPA may develop and make available, via its E-Enterprise portal, an electronic reporting system that Control Authorities could use to facilitate the receipt of reports from dental dischargers, if they choose to do so. At some future date, EPA could decide to revise this final rule to require electronic reporting. If it chose to do so, EPA would first propose the revisions and provide an opportunity for public review and comment. Page 40 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Finally, the final rule requires dental offices to document certain operation and maintenance requirements and maintain all records of compliance, as described in the regulation, and to make them available for inspection. 4. Control Authority Oversight/Reporting EPA proposed to amend selected parts of the General Pretreatment Regulations (40 CFR part 403) in order to simplify oversight requirements for the approximately 117,000 dental offices subject to the proposed rule. Specifically, EPA proposed to amend 40 CFR part 403 to create a new classification of categorical industrial users specifically tailored to pretreatment standards for dental offices, dental industrial user (DIU). EPA proposed that as long as a dental office complied with the requirements for DIUs, that it would not be considered an SIU. Among other things, this would have reduced the General Pretreatment Regulation oversight requirements for Control Authorities, such as the requirement to issue a control mechanism and annual inspection and sampling. EPA received numerous comments related to the proposed change, particularly from the Control Authorities. These commenters largely supported the reduced oversight requirements in the proposal, but encouraged EPA to reduce them further so that dental offices would never be SIUs, primarily due to concerns over the associated burden given the large number of dental offices potentially subject to the rule. In addition, Control Authorities raised concerns that they would have to update state and local laws to take advantage of the proposed changes to part 403 that would reduce the oversight requirements. They also raised concerns about additional reporting requirements for the Control Authorities typically associated with CIUs, such as identifying CIUs in their annual pretreatment report to the Approval Authority. Page 41 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. In response, EPA did not revise the General Pretreatment Standards to create the proposed DIU category and associated requirements. Rather, this rule establishes for the purposes of Part 441, that dental dischargers are not SIUs or CIUs as defined in 40 CFR part 403 unless designated as such by the Control Authority. This regulatory structure achieves the same goal as the proposed revisions to the General Pretreatment Standards - simplification of oversight requirements - without creating a need for updates to state and local laws. By establishing that dental dischargers are not SIUs or CIUs in the final rule, EPA eliminates the application of specific oversight and reporting requirements in 40 CFR part 403 such as permitting and annual inspections of dental dischargers for SIUs and CIUs unless the Control Authority chooses to apply these requirements to dental offices. This means that Control Authorities have discretion under the final rule to determine the appropriate manner of oversight, compliance assistance, and enforcement. 9 Further, the final rule reduced reporting for dental offices (and associated oversight requirements by Control Authorities) in comparison to reporting requirements for other industries subject to categorical pretreatment standards, as it requires only a One-Time Compliance Report be submitted to the Control Authority. The One-Time Compliance Report requirements specific to dental dischargers are included in this rule rather than in the General Pretreatment regulations so that they may be implemented directly. In summary, for this final rule, the Control Authorities must receive the One-Time Compliance Reports from dental dischargers and retain that notification according to the standard records retention protocol contained in 403.12(o). 9 Nothing stated in this section shall be construed so as to limit EPA’s inspection and enforcement authority. Page 42 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Where EPA is the Control Authority, EPA expects to explore compliance monitoring approaches that support sector-wide compliance evaluations, to the extent practicable. States and POTWs that are the Control Authority may elect to use the same approach but are not required to do so. One approach may be periodic review and evaluation of nationwide data on releases of dental amalgam metals (e.g., mercury), relying on Discharge Monitoring Reports from POTWs, Annual Biosolids Reports from POTWs, emissions data from sludge incinerators, and supplemental data submitted to EPA under the Toxic Releases Inventory program. EPA may utilize an approach to compliance inspections that focuses on a statistically valid sample of the regulated community. EPA may then use the inspection findings from such an approach to identify common areas of noncompliance, which would inform decisions about needed outreach, compliance assistance, and training materials. EPA will work with state and local Control Authorities, the ADA and other partners to tailor oversight and outreach to the issues where such oversight and outreach is most likely to achieve compliance across the dental sector. 5. Interaction with Existing State and Local Mandatory Dental Amalgam Reduction Programs The final rule applies to both dental offices that are subject to existing mandatory state or local dental amalgam reduction programs and those that are not. Some proposal commenters, many of whom are in states and localities with existing programs, questioned the application of this rule to dentists already subject to state and local programs noting the duplicative requirements. While EPA found that many of the existing programs contained at least one attribute of this final rule (e.g. separators, reporting, BMPs, operation and maintenance), the majority did not contain all of the attributes. Generally, the additional requirements (and associated costs) of this final rule are incremental over existing mandatory state or local dental amalgam reduction requirements. For example, a dentist located in a state or locality that does Page 43 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. not require one or both of the BMPs specified in this rule must implement both BMPs. While the requirements of this rule are incremental to existing state and local regulatory requirements, EPA finds they are necessary to achieve the intended environmental objectives of the rule. Applying categorical pretreatment standards to pollutant discharges from dental offices irrespective of existing discharge requirements is consistent with the general approach to pretreatment standards under the CWA in that it establishes uniform requirements that form the floor of performance for all dischargers in a regulated category. In addition, requiring all dental offices to meet the same requirements, regardless of the applicability of other state or local requirements, avoids substantial implementation challenges and potential confusion associated with alternative approaches. EPA considered several approaches for accommodating dentists in states and localities with existing and local requirements. For example, EPA considered exempting dentists subject to equivalent state and local requirements from the scope of this rule. EPA rejected this approach, in part, due to the complexities and potential confusion associated with evaluating and communicating the equivalency of state and local requirements to this rule, particularly as they may change over time. The rule establishes clear requirements for all parties and compliance with the final rule is simple and straightforward for dental offices and the regulating authorities. It requires dental offices to install and operate a separator, to implement two BMPs, and to submit a One-time Compliance Report to the Control Authority. Thereafter, the dental office will be required to conduct ongoing operation and maintenance and maintain associated records. These activities can be facilitated by third parties such as dental office suppliers and amalgam separator manufacturers. EPA does not expect the federal requirements to conflict with existing state or Page 44 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. local mandatory amalgam reduction requirements. Rather, EPA concludes this final rule imposes only incremental additional requirements (e.g., one-time compliance report) to their Control Authority, if any, on dental offices already subject to state or local amalgam reduction requirements. For Control Authorities, because EPA significantly reduced the oversight requirements associated with this rule, the incremental costs and burden to apply the final rule’s requirements to dental facilities subject to some existing mandatory dental amalgam reduction requirements are minimal. The only incremental requirement associated with this rule is for the Control Authority to receive, review, and retain a One-time Compliance Report from dentists subject to this rule. 6. Variances The provision of this rule establishing that dental dischargers are not SIUs or CIUs unless designated as such by the Control Authority does not change the otherwise applicable variances and modifications provided by the statute. For example, EPA can develop pretreatment standards different from the otherwise applicable requirements for an individual existing discharger subject to categorical pretreatment standards if it is fundamentally different with respect to factors considered in establishing the standards applicable to the individual discharger. Such a modification is known as a “fundamentally different factors” (FDF) variance. See 40 CFR 403.13 and the preamble to the proposed rule (79 FR 63278-63279, October 22, 2014). FDF variances traditionally have been available to industrial users subject to categorical pretreatment standards. Whether or not a dental discharger is an SIU or CIU, it is subject to categorical pretreatment standards and therefore eligible to apply for an FDF variance. E. Pollutants of Concern and Pass Through Analysis Page 45 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. CWA section 301(b) directs EPA to eliminate the discharge of all pollutants where it is technologically available and economically achievable (after a consideration of the factors specified in section 304(b) of the Act). The first step in such an analysis is typically to identify Pollutants of Concern (POCs) – or the pollutants potentially regulated in the effluent guideline. For this rule, EPA identifies the primary metals in dental amalgam as pollutants of concern: mercury, silver, tin, copper, and zinc. Generally, in determining whether pollutants pass through a POTW when considering the establishment of categorical pretreatment standards, EPA compares the median percentage of the pollutant removed by POTWs achieving secondary treatment with the median percentage of the pollutant removed by facilities meeting BAT effluent limitations. EPA deems a pollutant to pass through a POTW when the percentage removed by POTWs is less than the percentage removed by direct dischargers complying with BPT/BAT effluent limitations. In this manner, EPA can ensure that the combined treatment at indirect discharging facilities and POTWs is at least equivalent to that obtained through treatment by a direct discharger, while also considering the treatment capability of the POTW. In the case of this final rulemaking, where EPA is only developing pretreatment standards, EPA compares the POTW removals with removals achieved by indirect dischargers using the technology that otherwise satisfies the BAT factors. Historically, EPA’s primary source of POTW removal data is its 1982 “Fate of Priority Pollutants in Publicly Owned Treatment Works” (also known as the 50 POTW Study). This well documented study presents data on the performance of 50 POTWs achieving secondary treatment in removing toxic pollutants. As part of the development of ELGs for the Centralized Waste Treatment (CWT) Industry promulgated in December 2000, EPA developed and documented a methodology, including data editing criteria, to calculate POTW percent removals Page 46 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. for various toxic pollutants from the data collected in the study. EPA provided the opportunity for public comment on the percent removal methodology and the resulting percent removals in the CWT proposal. EPA similarly used and presented this methodology and data in subsequent ELG proposals and final rules. Using its long-standing approach, for this final rule, EPA determined the median percent removal by POTWs achieving secondary treatment is 90.2 percent for total mercury, and 42.6 percent to 88.3 percent for the other pollutants of concern. As described above, the 50 POTW Study measured pollutant reductions on the basis of total metals. Total metals include particulate (suspended) and dissolved (soluble) forms of the metal. As discussed above, while mercury is present in dental amalgam in both the particulate and dissolved form, the vast majority (>99.6 percent) is particulate. While EPA does not have information on the distribution of the other metals, EPA reasonably assumes the same distribution for the other metals. Because secondary treatment technologies are not designed to remove dissolved metals, EPA assumes dissolved metals are not removed by POTWs and that the percent reductions for POTWs represent particulate reductions. To determine the median percent removal of the pollutants of concern by amalgam separators, EPA collected information on the efficacy of existing separators. EPA excluded those separators that did not meet the 2008 ISO standards. At proposal, EPA determined the median percent removal of total mercury to be 99.0 percent, which is the reported removal when testing each of the amalgam separators marketed in the U.S. as conforming to the ISO standard (DCN DA00233). Commenters noted that existing data on the effectiveness of separators is measured as a percent reduction in mass, reflecting the dental amalgam particulates (rather than total mercury) collected by the device. EPA agrees the ISO standard evaluates particulates from dental amalgam rather than total mercury, and has adjusted its terminology accordingly. Based on Page 47 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. updated information in the record, EPA determined the median percent removal of particulates by amalgam separators that meet the 2008 ISO standards is 99.3 percent. As such, because the median percent removal of amalgam separators exceeds the median percent removal of welloperated POTWs employing secondary treatment for mercury and the other POCs, EPA determines that mercury and the other POCs pass through. In addition to comments relating to dissolved mercury, EPA received other comments and data pertaining to the proposed median percent removal of ISO compliant amalgam separators. Some commenters supported the percentage identified in the proposal, noting that certain states require the same level of performance, or identifying separators documented as achieving or exceeding that removal efficiency. Other commenters questioned EPA’s use of the data collected when laboratories certify amalgam separators to meet the ISO standard. More specifically, they asserted that the 2008 ISO standard requires the removal efficiency of the amalgam separator to be at least 95 percent on a mass fraction basis and as such, the ISO standard is not a validated test for measuring higher efficiencies. These commenters offered no data to demonstrate that the reported removals in excess of 95 percent were inaccurate, nor did commenters provide other efficiency data for amalgam separators. As it represents the best data available for the final rule, EPA appropriately used the data as reported to estimate the efficacy of amalgam separators for these purposes. EPA notes that even if commenters correctly characterized the minimum percent removal efficiency of amalgam separators meeting the 2008 ISO standard as 95 percent, this is a higher removal rate than the median percent removal by POTWs for all POCs. Therefore, while EPA based its analysis in the final rule on the percent removals as reported, under either case, EPA determines that mercury and the other POCs pass through. Page 48 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Other commenters stated the 50 POTW Study data were old, and that current POTW removals are higher than 90 percent. Some provided case studies, many of which reflected POTWs with advanced treatment capabilities rather than secondary treatment. In particular, the National Association of Clean Water Agencies (NACWA) submitted data from a nationwide voluntary survey of its members regarding mercury reductions at POTWs. Based on its analysis of the data collected in this survey, NACWA calculated a three-year average removal efficiency of 94 percent. 10 EPA notes that even if EPA were to accept these data and analyses as presented by NACWA without further review, it would confirm EPA’s conclusion that pass through of POCs occurs because this percentage is less than the median efficiency of 2008 ISO compliant amalgam separators of 99.3 percent. EPA, however, gave full consideration to the NACWA survey and subjected the mercury influent and effluent data from the 41 POTWs from that survey to similar review and data editing criteria as influent and effluent data collected for the 50 POTW Study. In this way, EPA attempted to give the NACWA data full and equal consideration as the historical data from the 50 POTW Study. EPA created a database of the raw data in order to conduct its analysis. (DCN DA00463). When EPA calculated the median percent removal of the non-edited raw data as submitted by NACWA, the median plant performance was 93.8 percent, with a range of 57.2 percent to 99.1 percent. In reviewing the data used in that calculation, EPA identified numerous data points that would not satisfy the data editing criteria applied in the 50 POTW Study, 10 EPA notes that in conducting its pass through analysis, EPA calculates and compares median percent removals rather than average percent removals. Page 49 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. including data points representing combined data rather than raw data, order of magnitude outlier concentrations, and incorrectly reported units of measure. Other discrepancies between data and analyses from the 50 POTW Study and NACWA survey include upward bias of using data from voluntary respondents, representing non-detect influent concentrations as zero, 11 inclusion of several POTWs using BNR (biological nutrient removal) and other advanced treatment expected to perform better than secondary treatment, overrepresentation of areas with existing dental amalgam reduction programs, and underrepresentation of certain geographical areas. Sensitivity analyses around these data are found in the record. (DCN DA00464). Consequently, for all of the reasons identified above, for this final rule, EPA finds that data from the 50 POTW Study continues to represent the best data available to determine the percent removed nationwide by well operated POTWs employing secondary treatment. Based on the information in its record including full consideration of comments, EPA appropriately concludes that the median percent removal of amalgam separators is higher than the median percent removal of POTWs for mercury and the other pollutants of concern. As such, EPA concludes mercury and the other POCs pass through. VII. Technology Costs This section summarizes EPA’s approach for estimating incremental compliance costs to implement changes associated with this rule, while the TEDD provides detailed information on 11 EPA generally handles non-detect values in the reported data by replacing them with a value of one-half of the detection level for the observation that yielded the non-detect. This methodology is standard procedure for the ELG program as well as Clean Water Act assessment and permitting, Safe Drinking Water Act monitoring, and Resource Conservation and Recovery Act and Superfund programs; and this approach is consistent with previous ELGs. Page 50 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. the methodology. The costing methodology for the final rule is the same as that described in the proposal (79 FR 63269; October 22, 2014); however, EPA updated some of the specific data elements. EPA estimated compliance costs using data collected through EPA’s Health Services Industry Detailed Study (August 2008) [EPA-821-R-08-014], a review of the literature, information supplied by vendors, and data submitted with comments on the proposed rule. In estimating the total cost of the regulatory options, EPA estimated costs for the following components: capital costs and other one-time costs; installation costs; annual operation and maintenance costs; and recordkeeping and reporting costs. EPA incorporated information received in comments pertaining to specific elements of the cost analysis, resulting in an increase in the initial installation cost and a minor increase in the average costs of dental amalgam separators that meet the 2008 ISO standard. In addition, EPA adjusted the reporting and recordkeeping costs to reflect the final rule requirements. The cost estimates reflect the incremental costs attributed only to this final rule. For example, offices required by a state or local program to have an amalgam separator compliant with the 2008 ISO 11143 standard will not incur costs to retrofit a separator as a result of this rule. Others may certify that they do not place or remove amalgam. Such offices may still have costs under this final rule such as those associated with the one-time reporting requirement to certify that they do not place or remove amalgam. EPA’s cost methodology assumes dental offices would use the required BMPs in combination with 2008 ISO 11143 amalgam separators to comply with the rule. All final cost estimates are expressed in terms of 2016 dollars. EPA used a model office approach to calculate costs of this rule. Under this approach, EPA developed a series of model dental offices that exhibited the typical characteristics of the regulated dental offices, and then calculated costs for each type of model office. EPA then Page 51 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. determined how many of each model office accurately represented the full universe of affected offices. While this part of the methodology remains unchanged from the proposal, EPA updated the number of offices in each model to reflect current existing state and local programs and, in the case of very large offices, to reflect new data obtained in public comments on the number of clinics and schools subject to this rule. A. Costs for Model Dental Offices EPA used the model approach to estimate costs for offices that place or remove amalgam for this final rule. EPA developed compliance costs for seven models, where each model is based on the number of chairs in an office. The ranges for each model are as follows: 1 to 2 chairs, 3 chairs, 4 chairs, 5 chairs, 6 chairs, 7-14 chairs (average of 10 chairs), and 15 chairs. EPA developed the 15 chairs model specifically to represent large institutional offices. This is discussed separately below in Section VII.B. EPA developed two sets of costs for each model: one for offices that do not use an amalgam separator and one for offices that do use an amalgam separator. For those offices that currently do not use an amalgam separator, EPA estimated one-time and annual costs. One-time costs include purchase of the separator and installation, and preparation of the One-time Compliance Report. Annual costs, for those offices that do use an amalgam separator, include visual inspection, replacement of the amalgam-retaining unit (e.g., cartridge or filter), separator maintenance and repair, recycling (preparation and services), and recordkeeping. Recordkeeping costs include documentation of inspection, separator maintenance and repair, and recycling (preparation and services). EPA also estimated periodic recordkeeping costs associated with repairs and One-Time Compliance Reports for new offices, which are included in the total of recordkeeping costs. Annual costs also include a cost offset, reflecting a Page 52 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. cost savings as a result of changes that occur in the dental office due to the final rule requirements. More specifically, EPA received data in comments that an amalgam separator would protect the vacuum system filter and impeller blade from small particles, resulting in less frequent replacement and servicing of these elements when an amalgam separator has been installed. In the final rule cost analysis, EPA accordingly reduced the overall operation and maintenance costs for those dental offices that do not already have an amalgam separator. This cost offset reflects the reduced cost to dental offices of servicing the vacuum system filter and impeller blade. A summary of costs for dental offices that do not currently use amalgam separators may be found in Tables VII-1 and VII-2, see the TEDD for more details. Table VII-1: Summary of One Time Model Facility Costs ($2016) for Dental Offices that Do Not Currently Use Amalgam Separators Cost Element Number of chairs in the model dental office Separator Purchase Installation One-Time Compliance Report 1 or 2 $437 $235 $23 3, 4, or 5 12 $697 $276 $23 6 $1,058 $276 $23 7 to 14 $1,291 $358 $23 15 $2,424 $942 $23 Table VII-2: Summary of Annual Model Facility Costs ($2016) for Dental Offices that Do Not Currently Use Amalgam Separators Cost Element Number of chairs in the model dental office 1 or 2 3, 4, or 5 13 6 7 to 14 15 Replacement Parts $275 $386 $559 $732 $1,078 Separator Maintenance $115 $115 $115 $115 $115 12 EPA assumed the separator can be sized for 3, 4, or 5 chairs, but has kept these three model office sizes distinct because the economic analysis evaluates different revenues for each of these sized offices. 13 EPA assumed the separator can be sized for 3, 4, or 5 chairs, but has kept these three model office sizes distinct because the economic analysis evaluates different revenues for each of these sized offices. Page 53 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Maintenance Cost Off-set -$75 -$75 -$75 -$75 -$75 Recycling $91 $91 $91 $91 $91 Visual Inspection $18 $18 $18 $18 $18 Recordkeeping $62 $62 $62 $62 $62 For those offices that already have an amalgam separator, EPA calculated costs for certain incremental annual costs associated with the amalgam separator required for this rule. Because these offices have separators, EPA only included a one-time cost for a One-Time Compliance Report ($23/office). Annual costs for such offices include visual inspection, replacement of the amalgam-retaining unit, separator maintenance and repair, recycling (preparation and services), and recordkeeping. Because these offices have amalgam separators in place, they are already incurring the majority of these costs irrespective of this final rule. As such, for those components (e.g., replacement of the cartridge and operation and maintenance), EPA calculated their incremental costs as a portion (percentage) of annual costs for dental offices without technology in place. Recordkeeping costs include documentation of inspection, separator maintenance and repair, and recycling (preparation and services). EPA also estimated periodic recordkeeping costs associated with repairs and One-Time Compliance Reports for new offices, which are included in the total of recordkeeping costs. EPA did not include the cost offset in this model, as described above. A summary of these annual costs may be found in Table VII-3, see the TEDD for more details. Table VII-3: Summary of Annual Model Facility Costs ($2016) for Dental Offices that Currently Use Amalgam Separators Cost Element Number of chairs in the model dental office 1 or 2 3, 4, or 5 14 6 7 to 14 15 14 EPA assumed the separator can be sized for 3, 4, or 5 chairs, but has kept these three model office sizes distinct because the economic analysis evaluates different revenues for each of these sized offices. Page 54 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Replacement Parts Separator Maintenance Recycling Inspection Recordkeeping $138 $58 $45 $18 $62 $193 $58 $45 $18 $62 $280 $58 $45 $18 $62 $366 $58 $45 $18 $62 $539 $58 $45 $18 $62 In assessing the long term costs of rule compliance for these model offices (those with and without existing separators), EPA assumed that amalgam separators would have a service life of 10 years, at which time the amalgam separators would need to be replaced (DCN DA00163). Furthermore, the cost model assumes all dental amalgam separators installed prior to this rule would need to be replaced within 10 years of the effective date of this rule. Therefore, for the purposes of estimating compliance costs, EPA assumed that all offices subject to this rule would incur the cost of installing a new amalgam separator 10 years after the effective date of this rule. However, because various modifications needed by the office for initial amalgam separator installation would have already been completed, EPA has projected the installation costs for amalgam separators would be one-half of the cost of the original installation. EPA assumed that all dental offices would continue to incur recurring expenses such as O&M beyond year 10 in the same way as described for the initial installation. To the extent dental offices either close or certify they no longer remove or place amalgam, the costs are likely overstated. EPA projects that there will be no incremental costs associated with the required BMPs because 1) costs for non-oxidizing, pH neutral line cleaners are roughly equivalent to other line cleaners; and 2) dental offices will not incur additional costs by changing the location for flushing waste amalgam. B. Costs for Larger Institutional Dental Offices Institutional dental offices (e.g., military clinics or dental schools) have a larger number of chairs than the typical dental office. For these institutional dental offices, EPA developed a Page 55 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. costing methodology based on the methodology for offices described above. For purposes of costs, consistent with the proposal, EPA assumed the average institutional office has 15 chairs. 15 As shown in Chapter 9 of the TEDD, EPA has cost information for five amalgam separators that have a maximum design ranging from 17-22 chairs. EPA also has costs for a unit that can be custom sized for chair sizes of 16 or greater. EPA used the information for these six separators to estimate costs for institutional facilities. See DCN DA00454. These costs are likely overstated as they do not reflect opportunities the largest offices may have to share costs, 16 and they do not assume any economies of scale. In addition, it is possible that the largest offices have multiple plumbing lines, allowing the installation of dental amalgam separators (or equivalent devices) only for those chairs used for placing or removing amalgam. See the proposed preamble and the TEDD for additional details on the costing methodology for institutional offices. VIII. Pollutant Loads As was the case for costing, EPA does not have office-specific discharge data for the approximately 117,000 dental offices potentially subject to this rule. Instead, EPA modeled the baseline, pre-rule discharges of mercury based on nationwide estimates of amalgam restorations and removals, and did not calculate the pollutant reductions on a per office basis. Rather, EPA 15 This represents the number of chairs that can be used for the placement and/or removal of amalgam at a particular location. EPA received comments for institutional facilities indicating they had 7, 15, or 25 chairs. EPA selected the median of these values for purposes of this analysis. 16 For example, multiple offices located in a single building or complex may be able to share plumbing, vacuum systems, and may be able to install a larger separator rather than each office having its own separator. Page 56 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. calculated average mercury loadings by dividing the total number of annual procedures by the total number of dentists performing the procedure. 17 The technology basis used to estimate the compliance costs of this rule includes 2008 ISO 11143 amalgam separators available on the market today, and certain BMPs. The median performance of these separators is 99.3 percent. EPA assumes all offices have chair-side traps or a combination of chair-side traps and vacuum filters that result in 68 percent and 78 percent collection of dental amalgam, respectively (DCN DA00163). After accounting for mercury reductions achieved through existing chair-side traps and vacuum pump filters, EPA’s analysis reduces remaining mercury loads to reflect the combination of chair-side traps, vacuum filters, and amalgam separators. Therefore, EPA assumed a post-rule reduction in mercury loads to POTWs based on a 99.8 percent removal rate. This is the same approach and data that EPA presented in the proposal (79 FR 623275; October 22, 2014). Amalgam is comprised of roughly 49 percent mercury, 35 percent silver, 9 percent tin, 6 percent copper and 1 percent zinc (DCN DA00131). As explained earlier in Section VI, EPA concludes that the technology basis would be equally effective in reducing discharges of silver, tin, copper, and zinc as it is in reducing mercury. EPA therefore applied the same approach to estimating reductions of other metals found in dental amalgam. In other words, EPA assumes chair-side traps and the combination of chair-side traps and vacuum filters will result in 68 17 Because this approach is based on the number of dentists, it includes those dentists both at offices and institutional offices. Page 57 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. percent and 78 percent collection of these metals, respectively. Remaining amalgam metals are further reduced by an amalgam separator, as discussed above. A. National Estimate of Annual Pollutant Reductions to POTWs Associated with this Rule 18 1. Mercury EPA estimates the approximately 55,000 offices that install separators would obtain 99.3 percent removal of particulate mercury through the use of amalgam separators (median removal efficiency of amalgam separators; see Chapter 7 of the TEDD). This would result in reduction of particulate mercury discharges to POTWs by approximately 5.1 tons. Amalgam separators are not effective in removing dissolved mercury. However, dissolved mercury accounts for much less than 1 percent of the total mercury, so the form of mercury removed from discharges to POTWs is assumed to consist of particulate (solids) only. 2. Other Metals As explained earlier in Section VI, EPA concludes that the technology basis for this final rule would be equally effective in reducing discharges of silver, tin, copper, and zinc as it is in reducing mercury. Accordingly, EPA estimates a reduction of these metal discharges to POTWs of approximately 5.3 tons. 3. Total reductions EPA estimates this final rule would annually reduce particulate mercury and other metal particulate discharges by a total of 10.3 tons. 18 EPA’s approach is not dynamic, as it does not account for declining use of dental amalgam. See additional discussion in V.B. Page 58 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. B. National Estimate of Annual Pollutant Reductions to Surface Waters Associated with this Rule In order to evaluate final discharges of mercury (and other metals) to waters of the U.S. by the POTW, EPA used its 50 POTW Study to calculate POTW removals of each metal. As explained above, at baseline and prior to implementation of this rule, EPA estimates 5.1 tons of dental mercury particulates are collectively discharged annually to POTWs. Based on the 50 POTW Study, EPA estimates POTWs remove 90.2 percent of dental mercury from the wastewater. Thus, POTWs collectively discharge 1,003 pounds of mercury from dental amalgam to surface waters annually. Under this final rule, 99.8 percent of mercury particulates currently discharged annually to POTWs will be removed prior to the POTW. The POTWs then further remove 90.2 percent of the remaining particulate mercury from the wastewater. This reduces the total amount of dental mercury particulates discharged from POTWs nationwide to surface water to 11 pounds of mercury annually. In other words, discharges of dental mercury to waters of the U.S. from POTWs are expected to be reduced by 992 pounds per year. 19 Similarly, EPA’s 50 POTW Study data shows 42.6 percent to 88.3 percent of other metals in the wastewater are removed by POTWs. As explained above, EPA estimates 5.3 tons of other metals are also collectively discharged annually from dental offices to POTWs. Thus, POTWs collectively discharge approximately 2,178 pounds of other dental metals to surface waters annually. Following compliance with this rule, the total amount of other dental metal discharges from 19 Dissolved mercury accounts for a portion of surface water discharges, because amalgam separators do not remove dissolved mercury. Page 59 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. POTWs nationwide to surface waters will be approximately 24 pounds or a reduction of 2,153. See Chapter 11 of the TEDD for more details. IX. Economic Impact Analysis This section summarizes EPA’s assessment of the total annual costs and impacts of the final pretreatment standards on the regulated industry. A. Social Cost Estimates As described earlier in Section VI of this preamble, EPA based the technology standard for the final rule on a widely available technology, amalgam separators, and employment of readily available BMPs. Section VII provides a detailed explanation of how EPA estimated compliance costs for model dental offices. As applicable, EPA annualized the capital costs over a 20-year period at a discount rate of 7 percent and 3 percent 20 and summed these costs with the O&M and reporting/recordkeeping costs to determine an annual compliance cost estimate for each model facility. See the TEDD for more details. In order to develop a national estimate of social costs 21 based on these model offices, EPA estimated the number of dental offices represented by each model office. EPA categorized 20 See the TEDD for the reported analyses using both a 7 percent and 3 percent discount rate. 21 Costs of the rule, from the standpoint of cost to society, include compliance costs and administrative costs to Control Authorities. Social costs would also incorporate any adjustment based on a quantity demand response to a change in price driven by a price change due to cost pass-through to consumers. For this analysis, EPA is not able to demonstrate an observable change in price for dental services, therefore no observable change in amount of visits (quantity demanded). Therefore, EPA makes no adjustment to social costs based on a change in quantity. Page 60 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. dental offices based on the number of chairs in each office. 22 The 2012 Economic Census does not provide information on the distribution of dental offices by the number of chairs in each office. However, two studies, the ADA National Study and a Colorado Study, estimate distribution of dentist offices by number of chairs (DCN DA00141 and DCN DA00149). EPA used these two data sources to correlate the number of chairs per office to the revenue range of dental offices. EPA averaged the correlation of these two studies to estimate the number of dental offices by the number of chairs. The results are reported in table IX-1: Table IX-1: Number of Dental Offices by Number of Chairs Number of Offices by Chair Size Number of Chairs ADA Survey Colorado Survey Average 1-2 chairs 16,606 12,976 14,791 3 chairs 33,738 31,329 57,841 4 chairs 38,928 33,924 5 chairs 19,032 18,425 35,638 6 chairs 7,786 12,802 7+ chairs 23,136 20,762 21,949 Total 133,221 133,221 133,221 To estimate nationwide social costs, EPA multiplied the estimated total annualized costs of rule compliance for each model office by the estimated number of dental offices represented by that model (i.e. with the indicated number of chairs and with/without existing amalgam separators). In EPA’s analysis, for dental offices that do not place or remove amalgam, EPA assigned them costs for a baseline-compliance report. EPA then summed the values for each chair range over the number of chair ranges to yield the total estimated compliance cost. Similarly, EPA calculated costs for institutional offices by multiplying the compliance cost for its 22 Amalgam separators are typically designed based on the number of chairs. Page 61 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. model institutional offices (15-chair model) by the number of estimated institutional offices indicated in Section V. Lastly, EPA estimated costs for Control Authorities to administer the final rule. Details of this cost analysis can be found in the TEDD. See Table IX-2 for EPA’s estimate of total nationwide annualized social costs for this final rule using a 3 percent discount rate. 23 Table IX-2: Total Annualized Social Costs by Number of Chairs (millions of 2016 dollars) Total Annualized Costs by Chair Size1 Number of Chairs Colorado Survey ADA Survey 1-2 chairs $4.2 3 chairs $13.6 4 chairs $15.7 5 chairs $7.7 6 chairs $4.0 7-14 chairs $13.1 15 chairs $0.3 Cost to Control Authorities $0.8 Total Annualized Social Costs $59.4 $5.4 $23.3 $16.4 $14.6 $0.3 $0.8 $60.8 1. These costs reflect estimated costs discounted to the year of promulgation. EPA assumed that initial capital outlays and initial incurrence of ongoing compliance expenses would occur in the third year following rule promulgation. EPA assumed that the amalgam separator technology would have a service life of 10 years, and used a 20-year analysis period to allow for one-time replacement of capital equipment 10 years following the initial installation. A 3 percent discount rate was used for the analysis reported in this table; see the TEDD for the analysis reported with a 7% discount rate. B. Economic Impact EPA devised a set of tests for analyzing economic achievability. As is often EPA’s practice, the Agency conducted a cost-to-revenue analysis to examine the relationship between the costs of the rule to current (or pre-rule) dental office revenues as a screening analysis. In addition, EPA chose to examine the financial impacts of the rule using two measures that utilize 23 As a point of clarification, social costs equal the sum of compliance costs and administrative costs. Also, EPA used a 3 percent discount rate for the social costs analysis. Page 62 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. the data EPA has on dental office baseline assets and estimated replacement capital costs: (1) Ratio of the Final Rule’s Capital Costs to Total Dental Office Capital Assets and (2) Ratio of the Final Rule’s Capital Costs to Annual Dental Office Capital Replacement Costs. EPA did not conduct a traditional closure analysis for this final rule because EPA does not have detailed data on baseline financial conditions of dental offices. Also, closure analyses typically rely on accounting measures such as present value of after-tax cash flow, and such accounting measures are difficult to implement for businesses that are organized as sole proprietorships or partnerships, as typically is the case in the dental industry. EPA considered whether it should exclude these offices from the analyses, which is described further in EPA’s proposal (79 FR 63272; October 22, 2014). Because EPA did not receive any comments to the contrary, EPA used the same assumptions for this final rule as it did at proposal with regard to low-revenue offices. EPA concluded that offices making less than $25,400 were baseline closures as traditionally accounted for in cost and economic impact analysis for effluent guidelines rulemakings. Using the Economic Census, EPA estimated that to be approximately 531 offices. Still, because of the uncertainty here, EPA analyzed the impacts twice: (1) excluding dental offices that could represent baseline closures and (2) including all offices in the analysis. For each of the three analyses conducted below, EPA used the same methodology for the final rule’s impact analysis as described in the proposal because EPA did not receive any comments to suggest a different approach for each impact analysis. Lastly, EPA used a 7 percent discount rate for the costs used in these three analyses described below. See the proposed rule for further description of the analyses below (79 FR 63272; October 22, 2014). 1. Cost-to-Revenue Analysis To provide an assessment of the impact of the rule on dental offices, EPA used a cost-to- Page 63 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. revenue analysis as is standard practice when looking at impacts to small businesses under the Regulatory Flexibility Act (RFA) to determine if a rule has the potential to have a significant impact on a substantial number of small entities. The cost-to-revenue analysis compares the total annualized compliance cost of each regulatory option with the revenue of the entities. EPA estimated the occurrence of annualized compliance costs exceeding the 1 percent and 3 percent of revenue thresholds for the final rule twice: (1) excluding dental offices that could represent baseline closures (excluding baseline set-aside offices), and (2) including all offices in the analysis (including baseline set-aside offices). Table IX-3 summarizes the results from this analysis. As shown there, under either scenario, over 99 percent of dental offices subject to this rule would incur annualized compliance costs of less than 1 percent of revenue. With baseline set-asides excluded from the analysis, 808 offices (0.7 percent of offices using dental amalgam and exceeding the set-aside revenue threshold) are estimated to incur costs exceeding 1 percent of revenue; no offices are estimated to incur costs exceeding 3 percent of revenue. With baseline set-asides included in the analysis, 1,217 offices (1 percent of offices using dental amalgam) are estimated to incur costs exceeding 1 percent of revenue; 174 offices (0.1 percent of offices using dental amalgam) are estimated to incur costs exceeding 3 percent of revenue. Table IX-3: Cost-to-Revenue Analysis Impact Summary Costs > 1% Revenue Total Offices Number of Chairs by Chair Size Number Percent Excluding Baseline Set-Aside Offices from Analysis 1-2 chairs 12,914 808 6.3% 3 chairs 27,353 0 0.0% 4 chairs 29,619 0 0.0% 5 chairs 16,087 0 0.0% 6 chairs 11,177 0 0.0% 7-14 chairs 19,163 0 0.0% Total 116,313 808 0.7% Including Baseline Set-Aside Offices in Analysis Page 64 of 94 Costs >3% Revenue Number Percent 0 0 0 0 0 0 0 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. 1-2 chairs 3 chairs 4 chairs 5 chairs 6 chairs 7-14 chairs Total 12,914 27,353 29,619 16,087 11,177 19,163 116,313 1,217 0 0 0 0 0 1,217 9.4% 0.0% 0.0% 0.0% 0.0% 0.0% 1.0% 174 0 0 0 0 0 174 1.4% 0.0% 0.0% 0.0% 0.0% 0.0% 0.1% 2. Ratio of the Rule’s Capital Costs to Total Dental Office Capital Assets This ratio examines the initial spending on capital costs of compliance in relation to the baseline value of assets on the balance sheet of dental office businesses. EPA assumes a low ratio implies limited impact on dental offices’ ability to finance the initial spending on capital costs of the final rule. A high ratio may still allow costs to be financed but could imply a need to change capital planning and budgeting. Table IX-4 reports the findings from this analysis, specifically the weighted average of the initial spending on the proposed rule’s capital costs divided by total assets of dental office across the revenue range/number-of-chairs analysis combinations. With baseline set-asides excluded from the analysis, the resulting initial capital costs to total capital assets values are low, with an average value 0.4 percent to 0.7 percent for the no technology in-place case and zero percent for the technology in-place case. With baseline closures included in the analysis, the resulting initial capital costs to total capital assets values are low, with an average value 0.4 percent to 0.7 percent for the no technology in-place case and 0 percent for the technology inplace case. Table IX-4: Initial Spending as Percentage of Pre-Rule Total Dental Office Capital Assets1 No Technology in Technology in Place Place Number of Chairs Low High Low High Excluding Baseline Set-Aside Offices from Analysis 1-2 chairs 0.1% Page 65 of 94 0.0% 2.4% 1.2% This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. 3 chairs 0.0% 0.0% 0.9% 0.5% 4 chairs 0.0% 0.0% 0.6% 0.4% 5 chairs 0.0% 0.0% 0.3% 0.2% 6 chairs 0.0% 0.0% 0.3% 0.2% 7-14 chairs 0.0% 0.0% 0.2% 0.1% Weighted Average 0.0% 0.0% 0.7% 0.4% 1-2 chairs 0.1% 0.0% 3.0% 1.5% 3 chairs 0.0% 0.0% 0.9% 0.5% 4 chairs 0.0% 0.0% 0.6% 0.4% 5 chairs 0.0% 0.0% 0.3% 0.2% 6 chairs 0.0% 0.0% 0.3% 0.2% 7-14 chairs 0.0% 0.0% 0.2% 0.1% Weighted Average 0.0% 0.0% 0.7% 0.4% Including Baseline Set-Aside Offices in Analysis 1EPA used the baseline asset value for the minimum (reported as low) and maximum (reported as high) revenue values by number-of-chairs category as the denominator for the ratio. Total final rule compliance costs, as described in Section IX above, were assigned to each number-of-chairs category as the numerator for the ratio. 3. Comparison of the Rule’s Capital Costs to Annual Dental Office Capital Replacement Costs EPA also compared the initial spending on capital costs of compliance associated with this rule to the estimated capital replacement costs for a dental office business (e.g., computer systems, chairs, x-ray machines, etc.) across all chair sizes. The capital replacement costs represent a value that dental offices may reasonably expect to spend in any year to replace and/or upgrade dental office capital equipment. EPA assumes a low ratio implies limited impact on dental offices’ ability to finance the initial spending on capital costs of the final rule. A high ratio may still allow costs to be financed but could imply a need to change capital planning and budgeting. As expected, the results for this ratio are higher than the previous ratio in the test above, given that EPA expects replacement costs would be smaller than total capital assets. EPA performed this test because this ratio is based on a different data source, and so it provides an Page 66 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. independent check that abstracts from the limitations of the data used in the test above. The resulting values for the final rule range from 2.0 percent to 2.8 percent, with a weighted average of 2.4 percent across all chair size ranges. Table IX-5: Initial Spending as Percentage of Estimated Annual Dental Office Capital Replacement Costs1 Number of chairs 1-2 chairs 2.7% 3 chairs 2.8% 4 chairs 2.3% 5 chairs 2.0% 6 chairs 2.3% 7 chairs 2.5% 8 chairs 2.3% 9 chairs 2.1% Weighted Average 2.4% 1 EPA estimated capital replacement costs, accounting for the total value of equipment purchases for different numbers of chairs, and the composition of purchases by equipment life category by number-of-chairs as the denominator for the ratio. EPA assigned total final rule compliance costs, as described above in Section IX, to each number-of-chairs as the numerator for the ratio. C. Economic Achievability The analyses performed above inform the potential economic impact of this final rule on the dental office sector. In the cost-to-revenue analysis, EPA found that no more than 0.1 percent of offices, mostly in the lower revenue ranges, would potentially incur costs in excess of 3 percent of revenue. The two financial ratios reported in Tables IX-3 and IX-4 show that the final rule will not cause dental offices to encounter difficulty in financing initial spending on capital costs of the final rule. Based on the combined results of the three analyses and that EPA had no data since proposal to suggest otherwise, EPA determined that the final rule is economically achievable. Regarding large offices, EPA notes that, due to a lack of data, the economic impact analyses did not include large institutional offices. EPA did not receive comments indicating large offices would be impacted more or less than other dental offices subject to this rule. Given Page 67 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. the results of the economic analysis performed on a range of office sizes indicating that the rule is economically achievable, EPA finds the rule would similarly be achievable for large institutional offices. EPA determined that the final pretreatment standard for new sources will not be a barrier to entry. EPA relied on data describing the equipment needs and costs for starting a dental practice as compiled in Safety Net Dental Clinic Manual, prepared by the National Maternal & Child Oral Health Resource Center at Georgetown University (see DCN DA00143). Information from the Georgetown Manual demonstrates that the amalgam separator capital costs (based on costs for existing model offices as described in Section VII) comprised 0.2 percent to 0.3 percent of the cost of starting a dental practice as shown in Table IX-6 and, therefore, does not pose a barrier to entry. Table IX-6: Initial Spending as Percentage of Estimated Dental Office Start-Up Costs Number-of-chairs 1-2 chairs 0.3% 3 chairs 0.3% 4 chairs 0.3% 5 chairs 0.2% 6 chairs 0.3% 7 chairs 0.3% 8 chairs 0.3% 9 chairs 0.3% Weighted Average 0.3% X. Cost-Effectiveness Analysis EPA often uses cost-effectiveness analysis in the development and revision of ELGs to evaluate the relative efficiency of alternative regulatory options in removing toxic pollutants from effluent discharges to our nation’s waters. Although not required by the CWA, and not a Page 68 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. determining factor for establishing PSES or PSNS, cost-effectiveness analysis can be a useful tool for describing regulatory options that address toxic pollutants. EPA defines the cost-effectiveness of a regulatory option as the incremental annual cost (in 1981 constant dollars to facilitate comparison to ELGs for other industrial categories promulgated over different years) per incremental toxic-weighted pollutant removals for that option. For more information about the methodology, data, and results, see Chapter 12 of the TEDD. EPA determines toxic-weighted pollutant removals for a particular pollutant by multiplying the number of pounds of a pollutant removed by an option by a toxic weighting factor (TWF). The toxic weighting factor for each pollutant measures its toxicity relative to copper, 24 with more toxic pollutants having higher toxic weights. The use of toxic weights allows EPA to express the removals of different pollutants on a constant toxicity basis as toxicpound-equivalents (lb-eq). In the case of indirect dischargers, the removal also accounts for the effectiveness of treatment at POTWs and reflects the toxic-weighted pounds after POTW treatment. The TWFs for the pollutants of concern are shown in Table X-1. 24 When EPA first developed TWFs in 1981, it chose the copper freshwater chronic aquatic life criterion of 5.6 μg/L as the benchmark scaling factor for deriving TWFs because copper was a common and well-studied toxic chemical in industrial waste streams. Consequently, the basic equation for deriving the TWF for any chemical is: TWF = 5.6 μg/L / Aquatic Life Value (μg/L) + 5.6 μg/L / Human Health Value (μg/L). The chronic freshwater aquatic life criterion for copper, however, has been revised three times since it was first published in 1980 due to advances in the scientific understanding of its toxic effects. Thus, when calculating the TWF for copper, EPA normalizes the 1998 chronic freshwater aquatic life copper criterion of 9.0 μg/L to the original 1980 copper criterion of 5.6 μg/L by dividing 5.6 μg/L by 9.0 μg/L and adding the quotient to 5.6 μg/L divided by the copper human health value of 4444 μg/L, which results in a copper TWF of 0.623. Page 69 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Table X-1: Toxic Weighting Factors for Pollutants in Dental Amalgam Mercury 110 Silver 16.47 Tin 0.301 Copper 0.623 Zinc 0.047 The costs used in the cost-effectiveness analyses are the estimated annual pre-tax costs described in Section IX, restated in 1981 dollars as a convention to allow comparisons with the reported cost effectiveness of other effluent guidelines. Collectively, the final PSES requirements have a cost-effectiveness ratio of $190 - $195/lb-equivalent as shown in Table X-2 below. This cost-effectiveness ratio falls within the range of cost-effectiveness ratios for PSES requirements in other industries. A review of approximately 25 of the most recently promulgated or revised categorical pretreatment standards shows PSES cost-effectiveness ranges from less than $1/lbequivalent (Inorganic Chemicals) to $380/lb-equivalent (Transportation Equipment Cleaning) in 1981 dollars. Table X-2: PSES Cost Effectiveness Analysis Final Option Pre-Tax Total Annualized Costs ($1981 M) Colorado Survey $23.5 ADA National Survey $24.1 Removals (lbs-eq) 123,552 123,552 Average Cost Effectiveness $190 $195 XI. Environmental Assessment A. Environmental Impacts EPA conducted a literature review concerning potential environmental impacts associated with mercury in dental amalgam discharged to surface water by POTWs (DCN DA00148). As discussed above, studies indicate that dental offices are the largest source of mercury entering Page 70 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. POTWs. The total annual baseline discharge of dental mercury to POTWs is approximately 10,239 pounds (5.1 tons): 10,198 pounds are in the form of solid particles (99.6 percent) and 41 pounds (0.4 percent) are dissolved in the wastewater (DCN DA00018). Through POTW treatment, approximately 90 percent of dental mercury is removed from the wastewater and transferred to sewage sludge. The 10 percent of dental mercury not removed by POTW treatment is discharged to surface water. EPA estimates that POTWs annually discharge approximately 1,003 pounds of dental mercury nationwide. The CWA regulations known as Standards for Use and Disposal of Sewage Sludge, 40 CFR part 503, control the land application, surface disposal, and incineration of sewage sludge generated by POTWs. Of the 11.2 billion dry pounds of sewage sludge generated annually, about 60 percent, or 6.7 billion pounds, are treated to produce biosolids for beneficial use as a soil amendment and applied to about 0.1 percent of agricultural lands in the United States (DCN DA00257). Approximately 5,500 pounds per year of dental mercury are contained in landapplied biosolids. Approximately 18 percent, or 2 billion pounds, of the sewage sludge generated annually by POTWs are surface disposed in sewage sludge mono-fills or municipal landfills. Approximately 1,700 pounds per year of dental mercury are contained in surface disposed sewage sludge. Pollutant limits and monitoring requirements for surface disposed sewage sludge mono-fills are set by 40 CFR part 503 and by 40 CFR part 258 for municipal landfills. There may be additional state or local regulations that are more stringent than the federal biosolids regulations. The remaining 22 percent, or 2.5 billion pounds, of sewage sludge generated annually by POTWs is disposed of through incineration. Approximately 2,000 pounds per year of dental Page 71 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. mercury are contained in incinerated sewage sludge. 40 CFR part 503, subpart E sets requirements for the incineration of mercury and other toxic metals in sludge. For mercury, subpart E provides that incineration of sludge must meet the requirements of the National Emissions Standards for Mercury in subpart E of 40 CFR part 61. Environmental assessment of impacts associated with POTW discharges of dental mercury is complicated by uncertainties about the fate and transport of mercury in aquatic environments. The elemental form of mercury used in dentistry has low water solubility and is not readily absorbed when ingested by humans, fish, or wildlife. However, elemental mercury may be converted into highly toxic methylmercury in aquatic environments by certain forms of anaerobic sulfate-reducing bacteria. Methylmercury has high potential to become increasingly concentrated up through aquatic food chains as larger fish eat smaller fish. Fish commonly eaten by humans may have methylmercury levels 100,000 times that of ambient water. The neurological effects of consumption of methylmercury-contaminated fish are well documented. Developmental effects to fetuses, infants, children, and fish consumption by women of childbearing age are of special concern. Neurological effects from predation of methylmercurycontaminated fish have been documented to occur in wild populations of fish, birds, and mammals in many areas of the United States (DCN DA00202). A plausible link has been identified between anthropogenic sources of mercury in the United States and methylmercury in fish. However, fish methylmercury concentrations also result from existing background concentrations of mercury which may consist of mercury from natural sources and atmospheric deposition of mercury in the United States from sources in other countries. Given the current scientific understanding of the environmental fate and transport of mercury, it is not possible to Page 72 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. quantify how much of the methylmercury in fish consumed by the U.S. population is contributed by U.S. emissions relative to international mercury sources or natural mercury sources. EPA was unable to assess the specific environmental impacts of dental mercury discharged by POTWs due to insufficient data needed to evaluate several fundamental factors about the discharge, fate, and transport of dental mercury in aquatic environments, including: the degree and geographic extent of dental mercury methylation in aquatic environments, the amount of methylated dental mercury that is taken up by fish and wildlife, the human consumption rates of fish contaminated with methylated dental mercury, and the extent and magnitude of naturallyoccurring mercury in aquatic environments. B. Environmental Benefits While EPA did not perform a quantitative environmental benefits analysis of the final rule, due to insufficient data about the aquatic fate and transport of dental mercury discharged by POTWs, EPA was able to assess the qualitative environmental benefits based on existing information. For example, EPA identified studies that show that decreased point-source discharges of mercury to surface water result in lower methylmercury concentrations in fish. Moreover, several studies quantify economic benefits from improved human health and ecological conditions resulting from lower fish concentrations of methylmercury (DCN DA00148). The final pretreatment standards will produce human health and ecological benefits by reducing the estimated annual nationwide POTW discharge of dental mercury to surface water from 1,003 pounds to 11 pounds. XII. Non-Water Quality Environmental Impacts Associated with the Technology Basis of the Rule Page 73 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Eliminating or reducing one form of pollution may cause other environmental problems. Sections 304(b) and 306 of the Clean Water Act require EPA to consider non-water quality environmental impacts (including energy requirements) associated with effluent limitations guidelines and standards. To comply with these requirements, EPA considered the potential impact of the technology basis on energy consumption, air pollution, and solid waste generation. As shown below, EPA anticipates that the rule would produce minimal non-water quality environmental impacts and as such determined they are acceptable. Additional information about the analysis of these non-water quality impacts is contained in the TEDD. A. Energy Requirements Net energy consumption considers the incremental electrical requirements associated with operating and maintaining dental amalgam separators used in combination with BMPs that form the technology basis for the standards. As described in Section V, most amalgam separators use sedimentation, either alone or in conjunction with filtration to remove solids in the waste stream. Most separators rely on gravity or the suction of the existing vacuum system to operate, and do not require an additional electrical power source. As noted in Section V, some separators have warning indicators that require a battery or power source. EPA does not anticipate this would pose any considerable energy requirements. Moreover, the addition of an amalgam separator is likely to reduce energy consumption at dental offices that do not currently employ an amalgam separator as it will prevent small particles from impeding the vacuum pump impeller. A clean impeller is more efficient than a dirty impeller, and thus will draw less energy (DCN DA00465). Upon consideration of all of these factors, EPA concludes there will be no significant energy requirements associated with this final rule. B. Air Emissions Page 74 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Unbound mercury is highly volatile and can easily evaporate into the atmosphere. An estimated 99.6 percent of dental mercury discharges are in solid bound form; i.e. elemental mercury bound to amalgam particles (DCN DA00018). Because the majority of dental mercury is bound to solid particles, it likely will not volatize to the atmosphere. Therefore, EPA expects the final PSES and PSNS will not pose any increases in air pollution. C. Solid Waste Generation In the absence of amalgam separators, a portion of the amalgam rinsed into chair-side drains is collected by chair-side traps. The remainder is discharged to the POTW where the vast majority is removed from the wastewater and becomes part of the POTW sludge that may be land-applied, disposed of in landfills or mono-fills, or incinerated. EPA expect the final rule to increase the use of amalgam separators nationwide by one and a half times with a corresponding increase in collection and recycling of used amalgam from the spent separator canisters. EPA expects the operation and maintenance requirements associated with the amalgam separator compliance option included in the final rule will further promote recycling as the primary means of amalgam waste management, because many amalgam separator manufactures and dental office suppliers have begun offering waste handling services that send dental amalgam waste to retorting and recycling facilities. Nationally, EPA expects less dental amalgam will be discharged to POTWs leading to reductions in the amount of mercury discharged to surface waters and land-applied, landfilled, or released to the air during incineration of sludge. Instead, EPA expects that the waste will be collected in separator canisters and recycled. After the amalgam containing waste has been recycled, the canisters are either recycled or landfilled. For purposes of assessing the incremental solid waste generation, EPA conservatively assumes all of the canisters are landfilled. EPA finds that if each dental office generated an average of 2 pounds Page 75 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. of spent canisters per year, the total mass of solid waste generated would still comprise less than 0.0001 percent of the 254 million tons of solid waste generated by Americans annually (DCN DA00496). Based on this evaluation of incremental solid waste generation, EPA concludes there will not be a significant incremental non-water quality impact associated with solid waste generation as a result of this final rule. XIII. Standards Incorporated by Reference This rule contains standards that are incorporated by reference from the American National Standards Institute/American Dental Association and the International Organization for Standardization. These standards comply with the National Technology Transfer Act (see Section XIV). The standards are available on their respective websites to everyone at a cost determined by the respective website, generally from $100 to $150. The cost of obtaining these standards is not a significant financial burden for a discharger or environmental laboratory, making the standards reasonably available. The individual standards are discussed in greater detail below. (a) New standards in §441.30(a)(1)(i) The installation, operation, and maintenance of one or more amalgam separators compliant with either the ADA 2009 standard with the 2011 addendum, or the ISO standard when removing dental amalgam solids from all amalgam process wastewater: (i) ANSI/ADA Specification No. 108:2009/ISO1143:2008, American National Standard/American Dental Association Specification No. 108 Amalgam Separators. (ii) ANSI/ADA Specification No. 108:2009 Addendum, American National Standard/American Dental Association Specification No. 108 Amalgam Separators, Addendum. (iii) International Standard ISO 11143, Dentistry – Amalgam Separators. Page 76 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. XIV. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review because it raises novel legal or policy issues. Any changes made in response to OMB recommendations have been documented in the docket. The economic analysis is available in the docket (DCN DA00458) and is briefly summarized in Section IX. The benefits are summarized in Section XI. B. Paperwork Reduction Act The information collection requirements in this final rule have been submitted for approval to the OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document prepared by EPA has been assigned EPA ICR number 2514.02. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them. EPA estimates it would take a total annual average of 402,000 hours and $7.2 million for affected dental offices to collect and report the information required in the final rule. This estimate includes effort for each dental office associated with completing a one-time compliance report. EPA based this estimate on average labor rates from the Bureau of Labor Statistics for the dental office personnel involved in collecting and reporting the information required. EPA estimates it would take a total annual average of 34,000 hours and $2.02 million for Control Page 77 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Authorities to review the information submitted by dental offices. EPA estimates that there would be no start-up or capital costs associated with the information described above. Burden is defined at 5 CFR 1320(b). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce the approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities in this final rule. C. Regulatory Flexibility Act I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are defined as: (1) a small business in the Dental Office sector (NAICS 621210) with annual receipts of 7.5 million dollars or less (based on SBA size standards); (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-forprofit enterprise which is independently owned and operated and is not dominant in its field. The Agency has determined that 116,014 dental offices out of 116,720 dental offices potentially subject to this final rule meet the small business definition. EPA’s analysis of projected impacts on small dental offices is described in detail in Section IX. EPA projects less than 1 percent of 116,720 affected dental offices would incur compliance costs exceeding 1 percent of revenue and no more than 0.2 percent would incur compliance costs exceeding 3 percent of revenue. Page 78 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this final rule on small entities. First, this final rule will allow dental offices with existing separators to satisfy the requirements for a period of up to 10 years. Second, EPA significantly reduced the rule’s reporting requirements for all affected dental offices as compared to the reporting requirements for other industries with categorical pretreatment standards. D. Unfunded Mandates Reform Act (UMRA) This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The annual cost of the final rule is $59 to $61 million; thus, this final rule is not subject to the requirements of sections 202 or 205 of UMRA. This final rule is also not subject to the requirements of section 203 of UMRA, because it contains no regulatory requirements that may significantly or uniquely affect small governments. EPA has not identified any dental offices that are owned by small governments. While this final rule impacts government entities required to administer pretreatment standards, small governments will generally not be affected. By statute, a small government jurisdiction is defined as a government of a city, county, town, school district or special district with a population of less than 50,000 (5 U.S.C 601). Control authorities are responsible for oversight and administration associated with this final rule. A POTW is required to become a Control Authority when it (or a combination of POTWs operated by the same authority) has a design flow of at least 5 million gallons per day and receives pollutants from industrial users that would pass through or interfere with the operations and cause a violation of the POTW’s NPDES permit. The average water use per person is 100 gallons per day so a POTW with a population Page 79 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. less than 50,000 would likely have a flow less than 5 MGD. Therefore, EPA does not expect small government owned POTWs to be required to become a Control Authority. EPA is aware that some small POTWs have approved pretreatment programs so they serve as a Control Authority. To the extent small POTWs with pre-existing approved pretreatment programs receive dental discharges subject to this rule, they would incur some incremental oversight requirements as described in Section VI. However, EPA expects such cases to be limited. E. Executive Order 13132: Federalism This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments This final rule does not have tribal implications, as specified in Executive Order 13175. It does not have substantial direct effects on Tribal governments, on the relationship between the Federal government and Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes. This final rule contains no Federal mandates for Tribal governments and does not impose any enforceable duties on Tribal governments. Thus, Executive Order 13175 does not apply to this final rule. G. Executive Order 13045: Protection of Children from Environmental Health and Safety Risks This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because EPA does not project the environmental health or safety risks addressed by this action present a disproportionate risk to children. This final rule will reduce the amount of mercury from dental amalgam entering Page 80 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. POTW’s and eventually the nation’s waters, which will reduce impacts to the neurological development of children. H. Executive Order 13211: Energy Effects This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. EPA determined that any additional energy usage would be insignificant to the total energy usage of Dental Offices and total annual U.S. energy consumption. I. National Technology Transfer Advancement Act This final rule involves technical standards. The Agency decided to use the American National Standards Institute (ANSI) American National Standard/American Dental Association (ADA) Specification 108 for Amalgam Separators (2009) with Technical Addendum (2011) or the International Organization for Standardization (ISO) 11143 Standard (2008) or the International Organization for Standardization (ISO) efficiency standards for amalgam separators (ISO 11143) developed in 1999 and updated in 2008. One approach to meet the standards in this rule is to install and operate an amalgam separator(s) compliant with one of these standards or their equivalent. These voluntary standard setting organizations established a standard for measuring amalgam separator efficiency by evaluating the retention of amalgam mercury using specified test procedures in a laboratory setting. They also include requirements for instructions for use and operation and maintenance. J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations EPA determined that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or Page 81 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). While EPA was unable to perform a detailed environmental justice analysis because it lacks data on the location of POTWs to which dental discharges currently occur, this final rule will increase the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. This final rule will reduce the amount of mercury from dental amalgam entering POTW’s and eventually the nation’s waters, to benefit all of society, including minority communities. K. Congressional Review Act (CRA) This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2). Page 82 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Title: Effluent Limitations Guidelines and Standards for the Dental Category Final Rule; page 83 of 94 List of Subjects in 40 CFR Part 441 Environmental protection, Dental, Dental office, Dentist, Mercury, Pretreatment, Waste treatment and disposal, Water pollution control. Dated: ______________________ ____________________________ Gina McCarthy, Administrator. Page 83 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. Therefore, 40 CFR part 441 is amended as follows: 1. Add part 441 to read as follows: PART 441 – DENTAL OFFICE POINT SOURCE CATEGORY Sec. 441.10 Applicability. 441.20 General definitions. 441.30 Pretreatment standards for existing sources (PSES). 441.40 Pretreatment standards for new sources (PSNS). 441.50 Discharge monitoring, reporting, and recordkeeping requirements. Authority: 33 U.S.C. 1251, 1311, 1314, 1316, 1317, 1318, 1342, and 1361. 42 U.S.C. 1310113103. § 441.10 Applicability. (a) Except as provided in paragraphs (c), and (d), and (e), this part applies to dental dischargers. (b) Unless otherwise designated by the Control Authority, dental dischargers subject to this part are not Significant Industrial Users as defined in 40 CFR 403, and are not “Categorical Industrial Users” or “industrial users subject to categorical pretreatment standards” as those terms and variations are used in 40 CFR part 403, as a result of applicability of this rule. (c) This part does not apply to dental dischargers that exclusively practice one or more of the following dental specialties: oral pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, periodontics, or prosthodontics. (d) This part does not apply to wastewater discharges from a mobile unit operated by a dental discharger. Page 84 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. (e) This part does not apply to dental dischargers that do not discharge any amalgam process wastewater to a POTW, such as dental dischargers that collect all dental amalgam process wastewater for transfer to a Centralized Waste Treatment facility as defined in 40 CFR 437. (f) Dental Dischargers that do not place dental amalgam, and do not remove amalgam except in limited emergency or unplanned, unanticipated circumstances, and that certify such to the Control Authority as required in § 441.50 are exempt from any further requirements of this part. § 441.20 General definitions. For purposes of this part: (a) Amalgam process wastewater means any wastewater generated and discharged by a dental discharger through the practice of dentistry that may contain dental amalgam. (b) Amalgam separator means a collection device designed to capture and remove dental amalgam from the amalgam process wastewater of a dental facility. (c) Control Authority is defined in 40 CFR 403.3(f). (d) Dental amalgam means an alloy of elemental mercury and other metal(s) that is used in the practice of dentistry. (e) Dental Discharger means a facility where the practice of dentistry is performed, including, but not limited to, institutions, permanent or temporary offices, clinics, home offices, and facilities owned and operated by Federal, state or local governments, that discharges wastewater to a publicly owned treatment works (POTW). (f) Duly Authorized Representative is defined in 40 CFR 403.12(l)(3). (g) Existing Sources means a dental discharger that is not a new source. Page 85 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. (h) Mobile unit means a specialized mobile self-contained van, trailer, or equipment used in providing dentistry services at multiple locations. (i) New Sources means a dental discharger whose first discharge to a POTW occurs after [INSERT DATE 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER]. (j) Publicly Owned Treatment Works is defined in 40 CFR 403.3(q). § 441.30 Pretreatment standards for existing sources (PSES). No later than [DATE 3 YEARS AFTER EFFECTIVE DATE OF THE FINAL RULE], any existing source subject to this part must achieve the following pretreatment standards: (a) Removal of dental amalgam solids from all amalgam process wastewater by one of the following methods: (1) Installation, operation, and maintenance of one or more amalgam separators that meet the following requirements: (i) Compliant with either the American National Standards Institute (ANSI) American National Standard/American Dental Association (ADA) Specification 108 for Amalgam Separators (2009) with Technical Addendum (2011) or the International Organization for Standardization (ISO) 11143 Standard (2008) or subsequent versions so long as that version requires amalgam separators to achieve at least a 95% removal efficiency. Compliance must be assessed by an accredited testing laboratory under ANSI’s accreditation program for product certification or a testing laboratory that is a signatory to the International Laboratory Accreditation Cooperation’s Mutual Recognition Arrangement. The Page 86 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. testing laboratory’s scope of accreditation must include ANSI/ADA 1082009 or ISO 11143. (ii) The amalgam separator(s) must be sized to accommodate the maximum discharge rate of amalgam process wastewater. (iii) A dental discharger subject to this part that operates an amalgam separator that was installed at a dental facility prior to [INSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER], satisfies the requirements of § 441.30(a)(1)(i-ii) until the existing separator is replaced as described in paragraph (v) of this section or until [INSERT DATE 10 YEARS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER], whichever is sooner. (iv) The amalgam separator(s) must be inspected in accordance with the manufacturer’s operating manual to ensure proper operation and maintenance of the separator(s) and to confirm that all amalgam process wastewater is flowing through the amalgam retaining portion of the amalgam separator(s). (v) In the event that an amalgam separator is not functioning properly, the amalgam separator must be repaired consistent with manufacturer instructions or replaced with a unit that meets the requirements of § 441.30(a)(i) and (ii) as soon as possible, but no later than 10 business days after the malfunction is discovered by the dental discharger, or an agent or representative of the dental discharger. Page 87 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. (vi) The amalgam retaining units must be replaced in accordance with the manufacturer’s schedule as specified in the manufacturer’s operating manual or when the amalgam retaining unit has reached the maximum level, as specified by the manufacturer in the operating manual, at which the amalgam separator can perform to the specified efficiency, whichever comes first. (2) Installation, operation, and maintenance of one or more amalgam removal device(s) other than an amalgam separator. The amalgam removal device must meet the following requirements: (i) Removal efficiency of at least 95 percent of the mass of solids from all amalgam process wastewater. The removal efficiency must be calculated in grams recorded to three decimal places, on a dry weight basis. The removal efficiency must be demonstrated at the maximum water flow rate through the device as established by the device manufacturer’s instructions for use. (ii) The removal efficiency must be determined using the average performance of three samples. The removal efficiency must be demonstrated using a test sample of dental amalgam that meets the following particle size distribution specifications: 60 percent by mass of particles that pass through a 3150 µm sieve but which do not pass through a 500 µm sieve, 10 percent by mass of particles that pass through a 500 µm sieve but which do not pass through a 100 µm sieve, and 30 percent by mass of particles that pass through a 100 µm sieve. Each of these three specified particle size distributions must contain a representative distribution of particle sizes. Page 88 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. (iii) The device(s) must be sized to accommodate the maximum discharge rate of amalgam process wastewater. (iv) The devices(s) must be accompanied by the manufacturer’s manual providing instructions for use including the frequency for inspection and collecting container replacement such that the unit is replaced once it has reached the maximum filling level at which the device can perform to the specified efficiency. (v) The device(s) must be inspected in accordance with the manufacturer’s operation manual to ensure proper operation and maintenance, including confirmation that amalgam process wastewater is flowing through the amalgam separating portion of the device(s). (vi) In the event that a device is not functioning properly, it must be repaired consistent with manufacturer instructions or replaced with a unit that meets the requirements of § 441.40(a)(2)(i), (ii) and (iii) as soon as possible, but no later than 10 business days after the malfunction is discovered by the dental discharger, or an agent or representative of the dental discharger. (vii) The amalgam retaining unit(s) of the device(s) must be replaced as specified in the manufacturer’s operating manual, or when the collecting container has reached the maximum filling level, as specified by the manufacturer in the operating manual, at which the amalgam separator can perform to the specified efficiency, whichever comes first. (viii) The demonstration of the device(s) under § 441.30 (a)(2)(i-iii) must be documented in the One-Time Compliance Report. Page 89 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. (b) Implementation of the following best management practices (BMPs): (1) Waste amalgam including, but not limited to, dental amalgam from chair-side traps, screens, vacuum pump filters, dental tools, cuspidors, or collection devices, must not be discharged to a POTW. (2) Dental unit water lines, chair-side traps, and vacuum lines that discharge amalgam process wastewater to a POTW must not be cleaned with oxidizing or acidic cleaners, including but not limited to bleach, chlorine, iodine and peroxide that have a pH lower than 6 or greater than 8. (c) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved material is available for inspection at EPA's Water Docket, EPA West, 1301 Constitution Avenue NW., Room 3334, Washington, DC 20004, Telephone: 202566-2426, and is available from the sources listed below. It is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (1) The following standards are available from the American Dental Association (ADA), 211 East Chicago Ave., Chicago IL 60611-2678, Telephone 312-4402500, http://www.ada.org. (i) ANSI/ADA Specification No. 108:2009/ISO1143:2008, American National Standard/American Dental Association Specification No. 108 Amalgam Separators. February 2009. Page 90 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. (ii) ANSI/ADA Specification No. 108:2009 Addendum, American National Standard/American Dental Association Specification No. 108 Amalgam Separators, Addendum. November 2011. (2) The following standards are available from the American National Standards Institute (ANSI), 25 West 43rd Street, 4th Floor New York, NY 10036, Telephone 212-642-4900, http://webstore.ansi.org. (i) International Standard ISO 11143, Dentistry – Amalgam Separators. Second edition, July 1, 2008. (ii) [Reserved] § 441.40 Pretreatment standards for new sources (PSNS). As of [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER], any new source subject to this part must comply with the requirements of § 441.30(a) and (b) and the reporting and recordkeeping requirements of § 441.50. § 441.50 Reporting, and recordkeeping requirements. (a) Dental Dischargers subject to this part must comply with the following reporting requirements in lieu of the otherwise applicable requirements in 40 CFR 403.12(b), (d), (e), and (g). (1) One-Time Compliance Report Deadlines. For existing sources, a One-Time Compliance Report must be submitted to the Control Authority no later than [INSERT DATE 3 YEARS AND 90 DAYS AFTER THE EFFECTIVE DATE OF THIS RULE] or 90 days after a transfer of ownership. For new sources, a Page 91 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. One-Time Compliance Report must be submitted to the Control Authority no later than 90 days following the introduction of wastewater into a POTW. (2) Signature and Certification. The One-Time Compliance Report must be signed and certified by a responsible corporate officer, a general partner or proprietor if the dental discharger is a partnership or sole proprietorship, or a duly authorized representative in accordance with the requirements of 40 CFR. § 403.12(l). (3) Contents. (i) The One-Time Compliance Report for dental dischargers subject to this part that do not place or remove dental amalgam as described at § 441.10(f) must include the: facility name, physical address, mailing address, contact information, name of the operator(s) and owner(s); and a certification statement that the dental discharger does not place dental amalgam and does not remove amalgam except in limited circumstances. (ii) The One-Time Compliance Report for dental dischargers subject to the standards of this part must include: A. The facility name, physical address, mailing address, and contact information. B. Name(s) of the operator(s) and owner(s). C. A description of the operation at the dental facility including: The total number of chairs, the total number of chairs at which dental amalgam may be present in the resulting wastewater, and a description of any existing amalgam separator(s) or equivalent Page 92 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. device(s) currently operated to include, at a minimum, the make, model, year of installation. D. Certification that the amalgam separator(s) or equivalent device is designed and will be operated and maintained to meet the requirements specified in § 441.30 or § 441.40. E. Certification that the dental discharger is implementing BMPs specified in § 441.30(b) or § 441.40(b) and will continue to do so. F. The name of the third-party service provider that maintains the amalgam separator(s) or equivalent device(s) operated at the dental office, if applicable. Otherwise, a brief description of the practices employed by the facility to ensure proper operation and maintenance in accordance with § 441.30 or § 441.40. (4) Transfer of Ownership Notification. If a dental discharger transfers ownership of the facility, the new owner must submit a new One-Time Compliance Report to the Control Authority no later than 90 days after the transfer. (5) Retention Period. As long as a Dental Discharger subject to this part is in operation, or until ownership is transferred, the Dental Discharger or an agent or representative of the dental discharger must maintain the One-Time Compliance Report required at § 441.50(a) and make it available for inspection in either physical or electronic form. (b) Dental Dischargers or an agent or representative of the dental discharger must maintain and make available for inspection in either physical or electronic form, for a minimum of three years: Page 93 of 94 This document is a prepublication version, signed by Administrator Gina McCarthy on December 15, 2016. We have taken steps to ensure the accuracy of this version, but it is not the official version. (1) Documentation of the date, person(s) conducting the inspection, and results of each inspection of the amalgam separator(s) or equivalent device(s), and a summary of follow-up actions, if needed. (2) Documentation of amalgam retaining container or equivalent container replacement (including the date, as applicable). (3) Documentation of all dates that collected dental amalgam is picked up or shipped for proper disposal in accordance with 40 CFR 261.5(g)(3), and the name of the permitted or licensed treatment, storage or disposal facility receiving the amalgam retaining containers. (4) Documentation of any repair or replacement of an amalgam separator or equivalent device, including the date, person(s) making the repair or replacement, and a description of the repair or replacement (including make and model). (5) Dischargers or an agent or representative of the dental discharger must maintain and make available for inspection in either physical or electronic form the manufacturers operating manual for the current device. Page 94 of 94 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 1 of 13 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK NATURAL RESOURCES DEFENSE COUNCIL, Plaintiff, v. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY, and CATHERINE MCCABE, in her official capacity as the Acting Administrator of the United States Environmental Protection Agency, Defendants. ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) 17-cv-751 ECF Case COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF INTRODUCTION 1. This lawsuit challenges the United States Environmental Protection Agency’s (EPA’s) unlawful rescission of a final rule promulgated under the Clean Water Act. The final rule would reduce the discharge of mercury and other toxic metals from dental offices into municipal sewage treatment plants and ultimately into the environment. 2. Mercury is a potent neurotoxin, and mercury releases into the environment can cause serious harm to human health, largely through consumption of contaminated seafood. 3. Mercury is used in dentistry as the main component of dental amalgams for fillings. The final mercury rule at issue here, formally titled “Effluent Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 2 of 13 Limitations Guidelines and Standards for the Dental Category,” would prevent dental offices from discharging into the environment 5.1 tons of mercury and 5.3 tons of other toxic metals each year. 4. The EPA Administrator signed the final mercury rule on December 15, 2016, and the agency delivered the final rule to the Office of the Federal Register for publication in the Federal Register. The Office of the Federal Register posted the final rule for public inspection on or before Thursday, January 19, 2017, and scheduled it for publication in the Federal Register. 5. EPA subsequently withdrew the rule from publication—and the Office of the Federal Register acquiesced in that withdrawal request—in response to a memorandum issued by the White House to all federal executive agencies late in the day on Friday, January 20, 2017, shortly after President Trump was inaugurated. 6. However, the final mercury rule was adopted and duly promulgated by EPA when it was signed by the EPA Administrator, sent to the Office of the Federal Register, and at the latest, when it was filed for public inspection. EPA’s rescission of the final rule without any public process violates the notice and comment requirements of the Administrative Procedure Act. 7. NRDC seeks an order vacating EPA’s withdrawal of the final mercury rule. 2 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 3 of 13 PARTIES 8. Plaintiff Natural Resources Defense Council is a national, non-profit environmental and public health organization with more than 325,000 members. NRDC engages in research, advocacy, media, and litigation related to protecting public health and the environment. NRDC’s mission includes preventing health threats posed by the release of mercury and other toxic chemicals to the environment. 9. Plaintiff brings this action on its own behalf and on behalf of its members and their children. Plaintiff’s membership includes individuals and families who are concerned about the health risks from exposure to mercury. Defendants’ rescission of the final mercury rule creates a risk of harm to plaintiff’s members and their children by perpetuating an ongoing source of mercury discharges to the environment, at an estimated rate of more than five tons of mercury per year. That harm would be redressed by an order invalidating EPA’s withdrawal of the final rule. Additionally, defendants’ failure to comply with noticeand-comment requirements before rescinding the rule harmed plaintiff and its members by depriving them of their right to comment on the rescission. Had plaintiff had an opportunity to comment, it would have opposed EPA’s repeal of the rule. 10. Defendant EPA is the federal agency responsible for implementing the Clean Water Act. 3 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 4 of 13 11. Defendant Catherine McCabe, Acting Administrator of the EPA, is the agency’s highest-ranking official. She is charged with the supervision and management of all decisions and actions of that agency. Plaintiff sues Acting Administrator McCabe in her official capacity. JURISDICTION AND VENUE 12. This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1331. 13. EPA’s withdrawal of the mercury rule is a final agency action subject to judicial review. 5 U.S.C. §§ 702, 704, 706. 14. This Court has the authority to issue the requested declaratory and injunctive relief pursuant to 28 U.S.C. §§ 2201-02 and 5 U.S.C. §§ 702 and 706. 15. The requested relief would redress the harm to plaintiff and its members caused by EPA’s unlawful withdrawal of the mercury rule. 16. Venue is proper in this district because plaintiff NRDC resides and has its principal place of business in this judicial district. 28 U.S.C. § 1391(c)(2), (e)(1). STATUTORY AND REGULATORY FRAMEWORK The Clean Water Act 17. Congress enacted the Clean Water Act in 1972 to “restore and maintain the chemical, physical, and biological integrity of the Nation’s waters.” 33 U.S.C. § 1251(a). The Clean Water Act sets as an ultimate goal the elimination of “the discharge of pollutants into the navigable waters.” Id. § 1251(a)(1). 4 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 5 of 13 18. Among other things, the Clean Water Act requires EPA to regulate the discharge of pollutants into the nation’s waters through municipal sewage plants, which are known as publicly owned treatment works, or POTWs. Id. § 1317(b). EPA sets technology-based “effluent limitations guidelines and standards” for categories of dischargers (in this case, dental offices), to minimize the amount of pollutants (in this case, mercury and other metals) those dischargers send through the sewers to POTWs and eventually to surface waters. Within ninety days after proposing standards under this subsection, the EPA Administrator “shall promulgate” those standards. Id. § 1317(b)(1). The Administrative Procedure Act 19. Under the Administrative Procedure Act (APA), an agency must publish a notice of proposed rulemaking in the Federal Register and solicit public comment before adopting or repealing a rule, unless the agency “for good cause” finds that notice and comment are “impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. § 553. The APA defines “rule making” as the “agency process for formulating, amending, or repealing a rule.” Id. § 551(5). The APA defines “rule” to include “the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy.” Id. § 551(4). 20. Under the APA, a reviewing court shall “hold unlawful and set aside” agency action that is “arbitrary, capricious, an abuse of discretion, or otherwise not 5 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 6 of 13 in accordance with law,” id. § 706(2)(A), or that is “without observance of procedure required by law,” id. § 706(2)(D). The Freedom of Information Act 21. The Freedom of Information Act (FOIA) mandates that “[e]ach agency shall separately state and currently publish in the Federal Register . . . substantive rules of general applicability adopted as authorized by law.” 5 U.S.C. § 552(a)(1)(D). 22. FOIA also provides that “[e]xcept to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published.” Id. § 552(a). The Federal Register Act 23. The Federal Register Act (FRA) directs that “[t]here shall be published in the Federal Register . . . documents or classes of documents that may be required so to be published by Act of Congress.” 44 U.S.C. § 1505(a)(3). Under FOIA, this includes agency rules. See 5 U.S.C. § 552(a)(1)(D). 24. The Office of the Federal Register is responsible for the prompt and uniform printing and distribution of documents required to be published in the Federal Register. 44 U.S.C. § 1502. The FRA requires that documents to be published in the Federal Register be filed with the Office of the Federal Register for processing prior to publication. Id. § 1503. Upon receipt, the Office of the Federal Register must make each document “immediately available for public inspection,” 6 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 7 of 13 and must transmit each document “immediately to the Government Publishing Office for printing” in the Federal Register. Id. 25. Under the FRA, “[a] document required . . . to be published in the Federal Register is not valid as against a person who has not had actual knowledge of it until . . . the document ha[s] been filed with the Office of the Federal Register and a copy made available for public inspection.” Id. § 1507. Unless otherwise provided by statute, “filing of a document . . . is sufficient to give notice of the contents of the document to a person subject to or affected by it.” Id. FACTUAL BACKGROUND AND PROCEDURAL HISTORY 26. Dentists use mercury in amalgams for dental fillings. Dental amalgam is almost fifty percent mercury by weight. The rest of the amalgam is usually composed of a combination of silver, tin, copper, zinc, and small amounts of indium and palladium. The mercury and other metals found in dental amalgam are concentrated and easy to remove. 27. Discharges of dental amalgam into public sewer systems occur when dentists are filling a cavity and excess amalgam is rinsed or suctioned out of the patient’s mouth. Dental amalgam discharges also occur when dentists remove old fillings that are worn or damaged, and the amalgam is rinsed or suctioned out of the patient’s mouth. 28. Dental offices are the main source of mercury discharges to municipal sewage treatment plants. Most of this mercury is subsequently released to the environment through surface water discharge or incineration, landfilling, or land 7 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 8 of 13 application of sewage sludge, which is the solid material that remains after wastewater is treated. Once released into the environment, mercury quickly becomes diffuse, and mercury pollution in the environment is difficult and costly to remove and remediate. 29. Mercury in the environment can be converted by bacteria into methylmercury, a highly toxic form of mercury that bioaccumulates in fish and shellfish. People are exposed to methylmercury principally by eating contaminated fish and shellfish. 30. In people, methylmercury harms the central nervous system. When it is ingested by a pregnant woman, methylmercury is absorbed into the bloodstream and distributed to the developing fetus. Methylmercury exposure during pregnancy can cause toxicity to the fetus’s developing brain. At very low levels of exposure— measured in parts per billion—this toxicity can cause permanent impairment, including decreases in motor function, attention span, verbal abilities, memory, and other cognitive facilities. 31. Although pregnant women and children are the populations at greatest risk, methylmercury is also toxic to adults, and can cause adverse cardiovascular effects in particular, including increased mortality from heart disease. 32. The final mercury rule at issue here establishes technology-based pretreatment standards for waste dental mercury. According to EPA, the rule sets a “uniform national standard that will greatly reduce the discharge of mercurycontaining dental amalgam to municipal sewage treatment plants.” Specifically, 8 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 9 of 13 “EPA expects compliance with this final rule will annually reduce the discharge of mercury by 5.1 tons as well as 5.3 tons of other metals found in waste dental amalgam,” including silver, tin, copper, and zinc. 33. The rule requires dental offices to use a “practical, affordable, and readily available technology for capturing mercury,” known as an amalgam separator, to capture waste mercury that can then be recycled. The rule also adopts certain “best management practices” recommended by the American Dental Association to reduce mercury discharges further. It is a “common sense step” to remove mercury from waste dental amalgam before it is dumped into the drain and released into the environment through sewage treatment plants, which cannot efficiently extract waste mercury. 34. In 2014, EPA issued an information collection request related to the proposed mercury rule, and plaintiff NRDC submitted public comments in response. EPA published the proposed mercury rule on October 22, 2014, and again solicited public comment. NRDC filed additional comments in response to the proposed rule. EPA also held a public hearing on November 10, 2014. 35. Under the Clean Water Act, EPA was required to finalize the mercury rule by January 20, 2015, which is ninety days from the date of proposal. 33 U.S.C. § 1317(b)(1). 36. After reviewing public comments, the EPA Administrator signed the final mercury rule on December 15, 2016. 9 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 10 of 13 37. The final rule was widely publicized, including within the regulated community. On the date the rule was signed by the EPA Administrator, the American Dental Association published a statement referring to the final rule as a “fair and reasonable approach to the management of dental amalgam waste.” The National Association of Clean Water Agencies, the trade association representing publicly owned treatment works, also published a statement, referring to the final rule as “a huge success” that “will have a minimal burden on POTWs.” 38. EPA sent the signed final rule to the Office of the Federal Register for formatting and publication. 39. On information and belief, and based on the Office of the Federal Register website, the Office of the Federal Register filed the final mercury rule for public inspection on Thursday, January 19, 2017, and scheduled the rule for publication on Tuesday, January 24. 40. President Trump was inaugurated at noon on Friday, January 20. Later that day, White House Chief of Staff Reince Priebus issued a “Memorandum for the Heads of Executive Departments and Agencies.” The Priebus Memorandum was made available on the White House website on January 20 and was published in the Federal Register on Tuesday, January 24. See 82 Fed. Reg. 8346 (Jan. 24, 2017). 41. Among other things, the Priebus Memorandum purports to direct federal agencies to “immediately withdraw” final rules sent to the Office of the Federal Register but not yet published in the Federal Register. The Priebus 10 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 11 of 13 Memorandum further states that agencies should exclude from withdrawal “any regulations subject to statutory or judicial deadlines.” 42. In response to the Priebus Memorandum, EPA sent the Office of the Federal Register a letter on January 23, asking to “withdraw all EPA documents currently at the Office of the Federal Register and scheduled for publication on January 24, 2017, or later.” EPA’s withdrawal letter lists all documents EPA believes to be subject to the Priebus Memorandum. In the letter, EPA characterizes the mercury rule as a “Final Rule” and notes that it is “already on public inspection.” 43. EPA asked to withdraw the final mercury rule from publication even though the Priebus Memorandum by its terms did not apply to that rule, because the rule was subject to a statutory deadline contained in the Clean Water Act, 33 U.S.C. § 1317(b)(1), and was required by law to be finalized within ninety days of its proposal. 44. The Office of the Federal Register acceded to the EPA withdrawal request and withdrew the final mercury rule from publication. CLAIM FOR RELIEF 45. Plaintiff incorporates by reference all preceding paragraphs. 46. EPA adopted the final mercury rule as authorized by law and was required to publish it in the Federal Register. See 5 U.S.C. § 552(a)(1)(D). At the latest, the final mercury rule was adopted and duly promulgated by EPA when it 11 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 12 of 13 was filed with the Office of the Federal Register and made available for public inspection. 44 U.S.C. § 1507. 47. EPA unlawfully withdrew the final mercury rule without publishing a notice of proposed rulemaking or providing an opportunity for public comment on the withdrawal, in violation of 5 U.S.C. § 553. 48. EPA’s withdrawal of the final mercury rule was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law,” id. § 706(2)(A), and was “without observance of procedure required by law,” id. § 706(2)(D). 49. EPA did not have good cause to disregard the notice and comment requirements of the APA when it withdrew the final mercury rule. 50. Neither the Priebus Memorandum nor any other authority provides a lawful basis for EPA’s repeal of the final rule without notice and comment. REQUEST FOR RELIEF Plaintiff respectfully requests that this Court enter judgment as follows: A. Declaring that EPA’s withdrawal of the final mercury rule without advance notice or an opportunity for public comment violates the APA; B. Vacating EPA’s withdrawal of the final mercury rule; C. Awarding plaintiff its costs and reasonable attorneys’ fees; and D. Granting such other relief that the Court considers just and proper. Respectfully submitted, /s/ Margaret T. Hsieh Margaret T. Hsieh Vivian H.W. Wang 12 Case 1:17-cv-00751 Document 1 Filed 02/01/17 Page 13 of 13 Natural Resources Defense Council 40 West 20th Street, 11th Floor New York, NY 10011 T: (212) 727-4652 F: (415) 795-4799 mhsieh@nrdc.org vwang@nrdc.org Counsel for Plaintiff Dated: February 1, 2017 13 Case 1:17-cv-00751-JPO Document 26 Filed 06/09/17 Page 1 of 2 U.S. Department of Justice [Type text] United States Attorney Southern District of New York 86 Chambers Street New York, New York 10007 June 9, 2017 By ECF Honorable J. Paul Oetken United States District Judge United States Courthouse 40 Foley Square New York, NY 10007 Re: Natural Resources Defense Council v. U.S. Environmental Protection Agency, 17 Civ. 751 (JPO) Dear Judge Oetken: This Office represents defendants United States Environmental Protection Agency and E. Scott Pruitt, Administrator of the United States Environmental Protection Agency (collectively, "EPA"), in the above-referenced matter, in which plaintiff Natural Resources Defense Council ("Plaintiff") seeks relief under the Administrative Procedure Act, 5 U.S.C. ? 551 et seq. and the Clean Water Act, 33 U.S.C. ? 1251 et seq. I write respectfully to request that EPA's June 14, 2017 deadline to file its opposition to Plaintiff's motion for summary judgment and its cross-motion to dismiss the amended complaint--as well as the remainder of the briefing schedule for these motions--be adjourned sine die. Plaintiff consents to the request to adjourn the briefing schedule. Earlier today, EPA submitted to the Office of the Federal Register ("OFR") for publication in the Federal Register a final rule entitled "Effluent Limitations Guidelines and Standards for the Dental Category" (the "dental amalgam rule"). The dental amalgam rule is substantively identical to the rule that EPA submitted to the OFR in January 2017, which was made available for public inspection on January 19, 2017, scheduled for publication in the Federal Register on January 24, 2017, and withdrawn from the OFR on January 23, 2017. Plaintiff's amended complaint alleges that EPA's withdrawal of the dental amalgam rule was unlawful, or, in the alternative, that EPA is in violation of a nondiscretionary duty to promulgate a final dental amalgam rule. See Am. Compl. ?? 55-56, 60-61. The publication of the dental amalgam rule will impact each of these claims. The parties propose that they submit a joint letter to the Court no later than 14 days after the dental amalgam rule is published in the Federal Register to outline any outstanding matters to be addressed in connection with this lawsuit, as well as a proposed schedule for presenting any such issues to the Court. This is EPA's first request to adjourn the briefing schedule established by the Court's March 29, 2017 order, see Dkt. No. 13, and as previously noted, Plaintiff consents to the request for an adjournment sine die. Case 1:17-cv-00751-JPO Document 26 Filed 06/09/17 Page 2 of 2 Page 2 We thank the Court for its consideration of this matter. Respectfully submitted, JOON H. KIM Acting United States Attorney for the Southern District of New York By: /s/ Andrew E. Krause ANDREW E. KRAUSE Assistant United States Attorney Telephone: 212-637-2769 Facsimile: 212-637-2786 E-mail: andrew.krause@usdoj.gov cc: All counsel of record via ECF 27154 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations and pests, Reporting and recordkeeping requirements. Dated: May 4, 2017. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. [FR Doc. 2017–12346 Filed 6–13–17; 8:45 am] BILLING CODE 6560–50–P Therefore, 40 CFR chapter I is amended as follows: ENVIRONMENTAL PROTECTION AGENCY PART 180—[AMENDED] 40 CFR Part 441 1. The authority citation for part 180 continues to read as follows: ■ [EPA–HQ–OW–2014–0693; FRL–9957–10– OW] Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.681 is amended as follows: ■ a. In the table in paragraph (a) alphabetically add the following commodities: ‘‘Apple, wet pomace’’; ‘‘Bushberry subgroup 13–07B’’; ‘‘Caneberry subgroup 13–07A’’; ‘‘Cherry subgroup 12–12A’’; ‘‘Fruit, pome, group 11–10’’; ‘‘Fruit, small vine climbing, except grape, subgroup 13–07E’’; ‘‘Pea and bean, dried shelled, except soybean, subgroup 6C’’; ‘‘Pea and bean, succulent shelled, subgroup 6B’’; ‘‘Peach subgroup 12–12B’’; ‘‘Plum, Prune, Dried’’; ‘‘Plum subgroup 12–12C’’; ‘‘Vegetable, legume, edible podded, subgroup 6A’’. ■ b. Paragraph (b) is revised. The additions and revision read as follows: ■ § 180.681 Isofetamid; tolerances for residues. (a) * * * Parts per million mstockstill on DSK30JT082PROD with RULES Commodity * * * * Apple, wet pomace ................... Bushberry subgroup 13–07B .... Caneberry subgroup 13–07A ... * * * * * Cherry subgroup 12–12A ......... * * * * * Fruit, pome, group 11–10 ......... * 0.60 * * * * Fruit, small vine climbing, except grape, subgroup 13–07E * * * * * Pea and bean, dried shelled, except soybean, subgroup 6C .......................................... Pea and bean, succulent shelled, subgroup 6B ............ Peach subgroup 12–12B .......... Plum, Prune, Dried ................... Plum subgroup 12–12C ............ 2.0 5.0 4.0 4.0 10.0 * 0.040 0.030 3.0 1.50 0.80 * * * * Vegetable, legume, edible podded, subgroup 6A ................. VerDate Sep<11>2014 16:55 Jun 13, 2017 (b) Section 18 emergency exemptions. [Reserved] * * * * * Jkt 241001 * 1.50 RIN 2040–AF26 Effluent Limitations Guidelines and Standards for the Dental Category Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: The Environmental Protection Agency (EPA) is promulgating technology-based pretreatment standards under the Clean Water Act to reduce discharges of mercury from dental offices into municipal sewage treatment plants known as publicly owned treatment works (POTWs). This final rule requires dental offices to use amalgam separators and two best management practices recommended by the American Dental Association (ADA). This final rule includes a provision to significantly reduce and streamline the oversight and reporting requirements in EPA’s General Pretreatment Regulations that would otherwise apply as a result of this rulemaking. EPA expects compliance with this final rule will annually reduce the discharge of mercury by 5.1 tons as well as 5.3 tons of other metals found in waste dental amalgam to POTWs. DATES: The final rule is effective on July 14, 2017. The compliance date, meaning the date that existing sources subject to the rule must comply with the standards in this rule is July 14, 2020. After the effective date of the rule, new sources subject to this rule must comply immediately with the standards in this rule. In accordance with 40 CFR part 23, this regulation shall be considered issued for purposes of judicial review at 1 p.m. Eastern time on June 28, 2017. Under section 509(b)(1) of the CWA, judicial review of this regulation can be had only by filing a petition for review in the U.S. Court of Appeals within 120 days after the regulation is considered issued for purposes of judicial review. Under section 509(b)(2), the requirements in this regulation may not be challenged later in civil or criminal proceedings brought by EPA to enforce these requirements. SUMMARY: PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 EPA has established a docket for this action under Docket ID No. EPA–HQ–OW–2014–0693. All documents in the docket are listed on the https://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. This material can be viewed at the Water Docket in the EPA Docket Center, EPA/ DC, EPA West William Jefferson Clinton Bldg., Room 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading room is 202–566–1744, and the telephone number for the Water Docket is 202– 566–2426. Publicly available docket materials are available electronically through http://www.regulations.gov. A detailed record index, organized by subject, is available on EPA’s Web site at https://www.epa.gov/eg/dentaleffluent-guidelines . FOR FURTHER INFORMATION CONTACT: For more information, see EPA’s Web site: https://www.epa.gov/eg/dental-effluentguidelines. For technical information, contact Ms. Karen Milam, Engineering and Analysis Division (4303T), Office of Water, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone: 202–566–1915; email: milam.karen@ epa.gov. ADDRESSES: SUPPLEMENTARY INFORMATION: I. Regulated Entities and Supporting Information A. Regulated Entities B. Supporting Information II. Legal Authority III. Executive Summary IV. Background A. Legal Framework 1. Clean Water Act 2. Effluent Limitations Guidelines and Standards a. Best Available Technology Economically Achievable (BAT) b. Best Available Demonstrated Control Technology (BADCT)/New Source Performance Standards (NSPS) c. Pretreatment Standards for Existing Sources (PSES) d. Pretreatment Standards for New Sources (PSNS) e. Best Management Practices (BMPs) B. Dental Sector Rulemaking History and Summary of Public Comments C. Existing State and Local Program Requirements D. Roles and Responsibilities Under the National Pretreatment Program E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations E. Minamata Convention on Mercury V. Description of Dental Industry & Dental Amalgam Wastewater Sources and Management A. Dental Industry B. Dental Amalgam Wastewater Sources and Management 1. Amalgam Separators 2. Polishing To Remove Dissolved Mercury From Wastewater 3. Wastewater Retention Tanks 4. Best Management Practices VI. Final Rule A. Scope and General Applicability B. Existing Source (PSES) Option Selection C. New Source (PSNS) Option Selection D. Requirements 1. Performance Standard 2. Applicability to Dental Offices That Do Not Place or Remove Dental Amalgam 3. Dental Discharger Reporting and On-Site Paperwork Compliance Requirements 4. Control Authority Oversight/Reporting 5. Interaction With Existing State and Local Mandatory Dental Amalgam Reduction Programs 6. Variances E. Pollutants of Concern and Pass-Through Analysis VII. Technology Costs A. Costs for Model Dental Offices XIII. Standards for Reference XIV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Energy Effects I. National Technology Transfer and Advancement Act J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations K. Congressional Review Act I. Regulated Entities and Supporting Information A. Regulated Entities Entities potentially regulated by this action include: North American Industry Classification System (NAICS) Code Category Example of regulated entity Industry .................................................... A general dentistry practice or large dental facility ................................................. This section is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated or affected by this final rule. Other types of entities that do not meet the above criteria could also be regulated. To determine whether your facility would be regulated by this final rule, you should carefully examine the applicability criteria listed in § 441.10 and the definitions in § 441.20 of this final rule and detailed further in Section VI of this preamble. If you still have questions regarding the applicability of this final rule to a particular entity, consult the person listed for technical information in the preceding FOR FURTHER INFORMATION CONTACT section. mstockstill on DSK30JT082PROD with RULES B. Costs for Larger Institutional Dental Offices VIII. Pollutant Loads A. National Estimate of Annual Pollutant Reductions to POTWs Associated With This Rule 1. Mercury 2. Other Metals 3. Total Reductions B. National Estimate of Annual Pollutant Reductions to Surface Waters Associated With This Rule IX. Economic Impact Analysis A. Social Cost Estimates B. Economic Impact 1. Cost-to-Revenue Analysis 2. Ratio of Rule’s Capital Costs to Total Dental Office Capital Assets 3. Comparison of the Rule’s Capital Costs to Annual Dental Office Capital Replacement Costs C. Economic Achievability X. Cost Effectiveness Analysis XI. Environmental Assessment A. Environmental Impacts B. Environmental Benefits XII. Non-Water Quality Environmental Impacts Associated With the Technology Basis of the Rule A. Energy Requirements B. Air Emissions C. Solid Waste Generation B. Supporting Information This final rule is supported by a number of documents including the Technical and Economic Development Document for the Final Effluent Limitations Guidelines and Standards for the Dental Category (TEDD), Document No. EPA–821–R–16–005. The TEDD and additional records are available in the public record for this final rule and on EPA’s Web site at https://www.epa.gov/eg/dental-effluentguidelines. VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 II. Legal Authority EPA promulgates this regulation under the authorities of sections 101, 301, 304, 306, 307, 308, and 501 of the CWA, 33 U.S.C. 1251, 1311, 1314, 1316, 1317, 1318, 1342 and 1361 and pursuant to the Pollution Prevention Act of 1990, 42 U.S.C. 13101 et seq. III. Executive Summary The purpose of this final rule is to set a uniform national standard that will greatly reduce the discharge of mercurycontaining dental amalgam to municipal sewage treatment plants, known as POTWs, in the United States. Mercury is a potent neurotoxin that bioaccumulates in fish and shellfish, and mercury pollution is widespread and a global concern that originates from many diverse sources such as air deposition from municipal and industrial incinerators and combustion of fossil fuels. Across the U.S., 12 states and at least 18 localities have established mandatory programs to reduce discharges of mercury to POTWs. As a result of these efforts, along with outreach from the ADA to promote voluntary actions to reduce such discharges, approximately 40 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 27155 621210 percent of the dentists subject to this rule already have installed amalgam separators. Amalgam separators greatly reduce the discharge of mercurycontaining amalgam to POTWs. Amalgam separators are a practical, affordable and readily available technology for capturing mercury at dental offices. The mercury collected by these separators can be recycled. This rule will ensure that mercury discharges to POTWs are effectively controlled at dental offices that discharge wastewater to POTWs. Many studies have been conducted in an attempt to identify the sources of mercury entering POTWs. According to the 2002 Mercury Source Control and Pollution Prevention Program Evaluation Final Report (DCN DA00006) prepared by the Association of Metropolitan Sewerage Agencies (AMSA), dental offices are the main source of mercury discharges to POTWs. A study funded by the ADA published in 2005 estimated that dental offices contributed 50 percent of mercury entering POTWs (DCN DA00163). Mercury is discharged in the form of waste dental amalgam when dentists remove old amalgam fillings from cavities, and from excess amalgam E:\FR\FM\14JNR1.SGM 14JNR1 mstockstill on DSK30JT082PROD with RULES 27156 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations waste when a dentist places a new amalgam filling. While dental offices are not a major contributor of mercury to the environment generally, dental offices are the main source of mercury discharges to POTWs. EPA estimates that across the United States 5.1 tons of mercury and an additional 5.3 tons of other metals found in waste dental amalgam are collectively discharged into POTWs annually. Mercury entering POTWs frequently partitions into the sludge, the solid material that remains after wastewater is treated. Mercury from waste amalgam therefore can make its way into the environment from the POTW through the incineration, landfilling, or land application of sludge or through surface water discharge. Once released into the aquatic environment, certain bacteria can change mercury into methylmercury, a highly toxic form of mercury that bioaccumulates in fish and shellfish. In the U.S., consumption of fish and shellfish is the main source of methylmercury exposure to humans. Removing mercury when it is in a concentrated and easy to manage form in dental amalgam, before it becomes diluted and difficult and costly to remove, is a common sense step to prevent mercury from being released into the environment where it can become a hazard to humans. The ADA, which supported removal and recycling of mercury from wastewater discharged to POTWs in its comments on the 2014 proposed rule (See DCN EPA–HQ–OW–2014–0693– 0434), developed best management practices (BMPs) to facilitate this goal and shared its recommendations widely with the dental community (DCN DA00165). The ADA’s voluntary amalgam waste handling and disposal practices include the use of amalgam separators to reduce mercury discharges. In addition, some states and localities have implemented mandatory programs to reduce dental mercury discharges that include the use of amalgam separators. EPA has concluded that requiring dental offices to remove mercury through relatively low-cost and readily available amalgam separators and BMPs makes sense. Capturing mercury-laden waste where it is created prevents it from being released into the environment. This final rule controls mercury discharges to POTWs by establishing a performance standard for amalgam process wastewater based on the use of amalgam separator technology. The rule also requires dental dischargers to adopt two BMPs, one which prohibits the discharge of VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 waste (‘‘or scrap’’), and the other which prohibits the use of line cleaners that may lead to the dissolution of solid mercury when cleaning chair-side traps and vacuum lines. In addition, the rule minimizes the administrative burden on dental offices subject to the rule, as well as on federal, state, and local regulatory authorities responsible for oversight and enforcement of the new standard. Administrative burden was a concern of many of the commenters on the 2014 proposed rule and EPA has greatly reduced that burden through streamlining the administrative requirements in this final rule. When EPA establishes categorical pretreatment requirements, it triggers additional oversight and reporting requirements in EPA’s General Pretreatment Regulations. The General Pretreatment Regulations specify that Control Authorities (which are often the state or POTW) are responsible for administering and enforcing pretreatment standards, including receiving and reviewing compliance reports. While other industries subject to categorical pretreatment standards typically consist of tens to hundreds of facilities, the dental industry consists of approximately 130,000 offices. Application of the default General Pretreatment Regulation oversight and reporting requirements to such a large number of facilities would be much more challenging. Further, dental office discharges differ from other industries for which EPA has established categorical pretreatment standards. Both the volume of wastewater discharged and the quantity of pollutants in the discharge on a per facility basis are significantly less than other industries for which EPA has established categorical pretreatment standards. Accordingly, this final rule exempts dental offices from the General Pretreatment Regulations’ oversight and reporting requirements associated with categorical pretreatment standards, reflecting EPA’s recognition that the otherwise-applicable regulatory framework for categorical dischargers would be unlikely to have a significant positive impact on overall compliance with the rule across the dental industry, while imposing a substantial burden on state and local regulating authorities. In order to simplify implementation and compliance for the dental offices and the regulating authorities, the final rule establishes that dental dischargers are not Significant Industrial Users (SIUs) as defined in 40 CFR part 403, and are not Categorical Industrial Users (CIUs) or ‘‘industrial users subject to categorical pretreatment standards’’ as PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 those terms and variations are used in the General Pretreatment Regulations, unless designated such by the Control Authority. While this rule establishes pretreatment standards that require dental offices to reduce dental amalgam discharges, the rule does not require Control Authorities to implement the traditional suite of oversight requirements in the General Pretreatment Regulations that become applicable upon the promulgation of categorical pretreatment standards for an industrial category. This significantly reduces the reporting requirements for dental dischargers that would otherwise apply by instead requiring them to demonstrate compliance with the performance standard and BMPs through a one-time compliance report to their Control Authority. This regulatory approach also eliminates the additional oversight requirements for Control Authorities that are typically associated with SIUs, such as permitting and annual inspections of individual dental offices. It also eliminates additional reporting requirements for the Control Authorities typically associated with CIUs, such as identification of CIUs in their annual pretreatment reports. At the same time, the final rule recognizes the Control Authority’s discretionary authority to treat a dental discharger as an SIU and/or CIU if, in the Control Authority’s judgement, it is necessary. EPA estimated the annual costs associated with this rule. EPA’s analysis reflects that many dental offices have already taken steps to reduce dental amalgam discharges by discontinuing the use of dental amalgam, adopting the ADA’s voluntary best practices, or by meeting existing mandatory state or local requirements. On a national basis, EPA estimates that approximately 40 percent of dental offices subject to this final rule already use amalgam separators (DCN DA00456). Of the remaining 60 percent of dental offices that do not have amalgam separators and that are subject to this final rule, EPA estimates that 20 percent do not place or remove dental amalgam (DCN DA00161). These dentists that do not place or remove dental amalgam— which correspond to 12 percent of the dental offices subject to this final rule— will incur little to no costs as a result of the rule. EPA estimates the remainder (representing 48 percent of the dental offices subject to this final rule) will incur an approximate average annual cost of $800 per office. The total annual cost of this final rule is projected to be $59–$61 million. This final rule will produce human health and ecological benefits by reducing the estimated annual E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations nationwide POTW discharge of dental mercury to surface water from 1,003 pounds to 11 pounds. Studies show that decreased point-source discharges of mercury to surface water have resulted in lower methylmercury concentrations in fish, and that such reductions can result in quantifiable economic benefits from improved human health and ecological conditions (DCN DA00148). While not quantified, as noted above, this rule will also reduce mercury releases to the environment associated with the incineration, landfilling, or land application of POTW sludges. Instead, EPA expects all of the collected amalgam will be recycled, rather than released back into the environment. IV. Background mstockstill on DSK30JT082PROD with RULES A. Legal Framework 1. Clean Water Act Congress passed the Federal Water Pollution Control Act Amendments of 1972, also known as the Clean Water Act (CWA), to ‘‘restore and maintain the chemical, physical, and biological integrity of the Nation’s waters.’’ (33 U.S.C. 1251(a)). The CWA establishes a comprehensive program for protecting our nation’s waters. Among its core provisions, the CWA prohibits the discharge of pollutants from a point source to waters of the U.S. except as authorized under the CWA. Under section 402 of the CWA, EPA authorizes discharges by a National Pollutant Discharge Elimination System (NPDES) permit. The CWA establishes a twopronged approach for these permits: Technology-based controls that establish the floor of performance for all dischargers, and water quality-based limits where the technology-based limits are insufficient for the discharge to meet applicable water quality standards. To serve as the basis for the technology-based controls, the CWA authorizes EPA to establish national technology-based effluent limitations guidelines and new source performance standards for discharges from different categories of point sources, such as industrial, commercial, and public sources, that discharge directly into waters of the U.S. Direct dischargers (those discharging directly to surface waters) must comply with effluent limitations in NPDES permits. Technology-based effluent limitations in NPDES permits for direct dischargers are derived from effluent limitations guidelines (CWA sections 301 and 304) and new source performance standards (CWA section 306) promulgated by EPA, or based on best professional judgment where EPA has not promulgated an applicable VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 effluent guideline or new source performance standard (CWA section 402(a)(1)(B) and 40 CFR 125.3). The effluent guidelines and new source performance standards established by regulation for categories of industrial dischargers are based on the degree of control that can be achieved using various levels of pollution control technology, as specified in the Act. EPA promulgates national effluent limitations guidelines and standards of performance for major industrial categories for three classes of pollutants: (1) Conventional pollutants (total suspended solids, oil and grease, biochemical oxygen demand, fecal coliform, and pH) as outlined in CWA section 304(a)(4) and 40 CFR 401.16; (2) toxic pollutants (e.g., toxic metals such as chromium, lead, mercury, nickel, and zinc) as outlined in section 307(a) of the Act, 40 CFR 401.15 and 40 CFR part 423, appendix A; and (3) nonconventional pollutants, which are those pollutants that are not categorized as conventional or toxic (e.g., ammoniaN, formaldehyde, and phosphorus). The CWA also authorizes EPA to promulgate nationally applicable pretreatment standards that restrict pollutant discharges from facilities that discharge pollutants indirectly, by sending wastewater to POTWs, as outlined in sections 307(b), (c) and 304(g) of the CWA. EPA establishes national pretreatment standards for those pollutants that may pass through, interfere with, or may otherwise be incompatible with POTW operations. CWA sections 307(b) and (c) and 304(g). The legislative history of the 1977 CWA amendments explains that pretreatment standards are technology-based and analogous to technology-based effluent limitations for direct dischargers for the removal of toxic pollutants. As further explained in the legislative history, the combination of pretreatment and treatment by the POTW is intended to achieve the level of treatment that would be required if the industrial source were making a direct discharge. Conf. Rep. No. 95–830, at 87 (1977), reprinted in U.S. Congress. Senate. Committee on Public Works (1978), A Legislative History of the CWA of 1977, Serial No. 95–14 at 271 (1978). As such, in establishing pretreatment standards, EPA’s consideration of pass through for national technology-based categorical pretreatment standards differs from that described in EPA’s General Pretreatment regulations at 40 CFR part 403. For categorical pretreatment standards, EPA’s approach for pass through satisfies two competing objectives set by Congress: (1) That standards for indirect dischargers be equivalent to standards PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 27157 for direct dischargers; and (2) that the treatment capability and performance of the POTWs be recognized and taken into account in regulating the discharge of pollutants from indirect dischargers. CWA 301(b)(1)(A)(BPT); and 301(b)(1)(E). 2. Effluent Limitations Guidelines and Standards EPA develops Effluent Guidelines Limitations and Standards (ELGs) that are technology-based regulations for specific categories of dischargers. EPA bases these regulations on the performance of control and treatment technologies. The legislative history of CWA section 304(b), which is the heart of the effluent guidelines program, describes the need to press toward higher levels of control through research and development of new processes, modifications, replacement of obsolete plants and processes, and other improvements in technology, taking into account the cost of controls. Congress has also stated that EPA need not consider water quality impacts on individual water bodies as the guidelines are developed; see Statement of Senator Muskie (October 4, 1972), reprinted in U.S. Senate Committee on Public Works, Legislative History of the Water Pollution Control Act Amendments of 1972, Serial No. 93–1, at 170). There are standards applicable to direct dischargers (dischargers to surface waters) and standards applicable to indirect dischargers (dischargers to POTWs). The types of standards relevant to this rulemaking are summarized here. a. Best Available Technology Economically Achievable (BAT) BAT represents the second level of stringency for controlling direct discharge of toxic and nonconventional pollutants. In general, BAT-based effluent guidelines and new source performance standards represent the best available economically achievable performance of facilities in the industrial subcategory or category. Following the statutory language, EPA considers the technological availability and the economic achievability in determining what level of control represents BAT. CWA section 301(b)(2)(A). Other statutory factors that EPA considers in assessing BAT are the cost of achieving BAT effluent reductions, the age of equipment and facilities involved, the process employed, potential process changes, and non- water quality environmental impacts, including energy requirements and such other factors as the E:\FR\FM\14JNR1.SGM 14JNR1 27158 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations Administrator deems appropriate. CWA section 304(b)(2)(B). The Agency retains considerable discretion in assigning the weight to be accorded these factors. Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1045 (D.C. Cir. 1978). b. Best Available Demonstrated Control Technology (BADCT)/New Source Performance Standards (NSPS) NSPS reflect effluent reductions that are achievable based on the best available demonstrated control technology (BADCT). Owners of new facilities have the opportunity to install the best and most efficient production processes and wastewater treatment technologies. As a result, NSPS should represent the most stringent controls attainable through the application of the BADCT for all pollutants (that is, conventional, nonconventional, and toxic pollutants). In establishing NSPS, EPA is directed to take into consideration the cost of achieving the effluent reduction and any non-water quality environmental impacts and energy requirements. CWA section 306(b)(1)(B). c. Pretreatment Standards for Existing Sources (PSES) Pretreatment standards apply to dischargers of pollutants to POTWs; Pretreatment Standards for Existing Sources are designed to prevent the discharge of pollutants to POTWs that pass through, interfere with, or are otherwise incompatible with the operation of POTWs, including sludge disposal methods of POTWs. Categorical pretreatment standards for existing sources are technology-based and are analogous to BAT effluent limitations guidelines, and thus the Agency typically considers the same factors in promulgating PSES as it considers in promulgating BAT. See Natural Resources Defense Council v. EPA, 790 F.2d 289, 292 (3rd Cir. 1986). mstockstill on DSK30JT082PROD with RULES d. Pretreatment Standards for New Sources (PSNS) Like PSES, PSNS are designed to prevent the discharges of pollutants that pass through, interfere with, or are otherwise incompatible with the operation of POTWs. New indirect discharges have the opportunity to incorporate into their facilities the best available demonstrated technologies. In establishing pretreatment standards for new sources, the Agency typically considers the same factors in promulgating PSNS as it considers in promulgating NSPS (BADCT). VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 e. Best Management Practices (BMPs) Section 304(e) of the CWA authorizes the Administrator to publish regulations, in addition to effluent limitations guidelines and standards for certain toxic or hazardous pollutants, ‘‘to control plant site runoff, spillage or leaks, sludge or waste disposal, and drainage from raw material storage which the Administrator determines are associated with or ancillary to the industrial manufacturing or treatment process . . . and may contribute significant amounts of such pollutants to navigable waters.’’ In addition, section 304(g), read in concert with section 501(a), authorizes EPA to prescribe as wide a range of pretreatment requirements as the Administrator deems appropriate in order to control and prevent the discharge into navigable waters, either directly or through POTWs, any pollutant which interferes with, passes through, or otherwise is incompatible with such treatment works. (see also Citizens Coal Council v. U.S. EPA, 447 F3d 879, 895–96 (6th Cir. 2006) (upholding EPA’s use of non-numeric effluent limitations and standards); Waterkeeper Alliance, Inc. v. U.S. EPA, 399 F.3d 486, 496–97, 502 (2d Cir. 2005) (EPA use of non-numerical effluent limitations in the form of BMPs are effluent limitations under the CWA); and Natural Res. Def. Council, Inc. v. EPA, 673 F.2d 400, 403 (D.C. Cir. 1982) (‘‘section 502(11) [of the CWA] defines ‘effluent limitation’ as ‘any restriction’ on the amounts of pollutants discharged, not just a numerical restriction.’’)) B. Dental Category Effluent Guidelines Rulemaking History and Summary of Public Comments EPA published the proposed rule on October 22, 2014, and took public comment through February 20, 2015. During the public comment period, EPA received approximately 200 comments. EPA also held a public hearing on November 10, 2014. Administrative burden was a concern of many of the commenters on the 2014 proposed rule, particularly from regulatory authorities responsible for oversight and enforcement of the new standard. Commenters also provided additional information on amalgam separators (e.g., costs, models, and design) as well as information on some other approaches to reduce pollutant discharges from dentists. Commenters also offered ways to improve and/or clarify the proposed pretreatment standards, including the proposed numerical efficiency and operation and maintenance PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 requirements. See DCN DA00516 for these comments and EPA’s responses. C. Existing State and Local Program Requirements Currently, 12 states (Connecticut, Louisiana,1 Maine, Massachusetts, Michigan, New Hampshire, New Jersey, New Mexico, New York, Rhode Island, Vermont, and Washington) have mandatory programs to reduce dental mercury discharges. Additionally, at least 18 localities (located in California, Colorado, Ohio, and Wisconsin) similarly have mandatory dental amalgam reduction pretreatment programs. EPA analyzed readily available information about these programs and found commonalities (DCN DA00524). For example, all require the use of amalgam separators and most specify associated operating and maintenance requirements. The majority of these programs also require some type of best management practices, and at least a one-time compliance report to the regulating authority. D. Roles and Responsibilities Under the National Pretreatment Program The National Pretreatment Program requires industrial dischargers that discharge to POTWs to comply with pretreatment standards. The General Pretreatment Regulations in 40 CFR part 403 establish roles and responsibilities for entities involved in the implementation of pretreatment standards. This section summarizes the roles and responsibilities of Industrial Users (IUs), Control Authorities, and Approval Authorities. For a detailed description, see the preamble for the proposed rule (79 FR 63279–63280; October 22, 2014). An IU is a nondomestic source of indirect discharge into a POTW, and in this rule is the dental discharger. The Control Authority may be the POTW, the state, or EPA, depending on whether the POTW or the state is approved by EPA to administer the pretreatment program. The Control Authority is the POTW in cases where the POTW has an approved pretreatment program. The Control Authority is the state, where the POTW has not been approved to administer the pretreatment program, but the state has been approved. The Control Authority is EPA where neither the POTW nor the state have been approved to administer the pretreatment program. The Approval Authority is the 1 Louisiana state requirements do not explicitly require dental offices to install amalgam separators; dental offices must follow BMPs recommended by the ADA in 1999. ADA added amalgam separators to the list of BMPs in 2008. E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations mstockstill on DSK30JT082PROD with RULES State (Director) in an NPDES authorized state with an approved pretreatment program; or the EPA regional administrator in a non-NPDES authorized state or NPDES state without an approved state pretreatment program. Typically, an IU is responsible for demonstrating compliance with pretreatment standards by performing self-monitoring, submitting reports and notifications to its Control Authority, and maintaining records of activities associated with its discharge to the POTW. The Control Authority is the regulating authority responsible for implementing and enforcing pretreatment standards. The General Pretreatment Regulations require certain minimum oversight of IUs by Control Authorities. The required minimum oversight includes receipt and analysis of reports and notifications submitted by IUs, random sampling and analyzing effluent from IUs, and conducting surveillance activities to identify occasional and continuing noncompliance with pretreatment standards. The Control Authority is also responsible for taking enforcement action as necessary. For IUs that are designated as Significant Industrial Users (SIUs), Control Authorities must inspect and sample the SIU effluent annually, review the need for a slug control plan, and issue a permit or equivalent control mechanism. IUs subject to categorical pretreatment standards are referred to as Categorical Industrial Users (CIUs). The General Pretreatment Regulations define SIU to include CIUs. The Approval Authority is responsible for ensuring that POTWs comply with all applicable pretreatment program requirements. Among other things, the Approval Authority receives annual pretreatment reports from the Control Authority. These reports must identify which IUs are CIUs. E. Minamata Convention on Mercury On November 6, 2013, the United States joined the Minamata Convention on Mercury, a new multilateral environmental agreement that addresses specific human activities that are contributing to widespread mercury pollution. The agreement identifies dental amalgam as a mercury-added product for which certain measures should be taken. Specifically, the Convention lists nine measures for phasing down the use of mercury in dental amalgam, including promoting the use of best environmental practices in dental offices to reduce releases of mercury and mercury compounds to water and land. Nations that are parties to the Convention are required to implement at least two of the nine VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 measures to address dental amalgam. This final rule contributes to the U.S.’s efforts to meet the measures called for in the treaty. V. Description of Dental Industry & Dental Amalgam Wastewater Sources and Management A. Dental Industry The industry category affected by this final rule is Offices of Dentists (NAICS 621210), which comprises establishments of health practitioners primarily engaged in the independent practice of general or specialized dentistry, or dental surgery. These practitioners operate individual or group practices in their own offices or in the offices of others, such as hospitals or health maintenance organization medical centers. They can provide either comprehensive preventive, cosmetic, or emergency care, or specialize in a single field of dentistry. According to the 2012 Economic Census, there are 133,221 U.S. dental offices owned or operated by 125,275 dental firms.2 Only 2 percent of all dental firms are multi-unit, the rest are single-unit. The growth of the number of dental offices remained steady over the past decade with an average increase of 1 percent per year. The industry includes mostly small businesses with an estimated over 99 percent of all offices falling below the Small Business Administration (SBA) size standard ($7.5 million in annual revenue). Using Census Bureau data, EPA estimates an average revenue for offices at $787,190 per year with an average of 6.6 employees per establishment. According to ADA data, approximately 80 percent of the dental industry engages in general dentistry. Approximately 20 percent are specialty dentists such as periodontists, orthodontists, radiologists, maxillofacial surgeons, endodontists, or prosthodontists (DCN DA00460). Dentistry may also be performed at larger institutional dental offices (military clinics and dental schools). Since EPA does not know if these offices are included in the 2012 Economic Census data, EPA conservatively assumed the largest offices are not present in the data, and so added an estimate of 415 larger institutional dental offices across the nation. For the final rule, EPA updated this number based on comments received on the proposed rule. 2 A firm is a business organization, such as a sole proprietorship, partnership, or corporation. PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 27159 B. Dental Amalgam Wastewater Sources and Management Dental amalgam consists of approximately 49 percent mercury by weight. Mercury is the only metal that is in its liquid phase at room temperature, and it bonds well with powdered alloy. This contributes to its durability in dental amalgam. The other half of dental amalgam is usually composed of 35 percent silver, 9 percent tin, 6 percent copper, 1 percent zinc and small amounts of indium and palladium (DCN DA00131). Sources of dental amalgam discharges generally occur in the course of two categories of activities. The first category of discharges may occur in the course of treating a patient, such as during the placement or removal of a filling. When filling a cavity, dentists overfill the tooth cavity so that the filling can be carved to the proper shape. The excess amalgam is typically rinsed into a cuspidor, or suctioned out of the patient’s mouth. In addition to filling new cavities, dentists also remove old restorations that are worn or damaged. Removed restorations also may be rinsed into a cuspidor or suctioned out of the patient’s mouth. Based on information in the record (DCN DA00456), removed restorations is the largest contributor of mercury in dental discharges. The second category of dental amalgam discharges occurs in the course of activities not directly involved with the placement or removal of dental amalgam. Preparation of dental amalgam, disposing of excess amalgam, and flushing vacuum lines with corrosive chemicals present opportunities for dental amalgam to be discharged. The use of dental amalgam has decreased steadily since the late 1970s as alternative materials such as composite resins and glass ionomers have become more widely available. Estimates show that placements of dental amalgam have decreased on average by about 2 to 3% per year (74 FR 38686; August 4, 2009). Based on this information, EPA estimates that mercury in dental amalgam discharges to POTWs will decrease by about half within the next 25 years. While the use of dental amalgam continues to decline, EPA estimates that approximately 2 tons of mercury would continue to be discharged to POTWs in 2040. The typical plumbing configuration in a dental office consists of a chair-side trap for each chair, and a central vacuum pump with a vacuum pump filter. Chair-side traps and vacuum pump filters remove approximately 78 E:\FR\FM\14JNR1.SGM 14JNR1 27160 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations percent of dental amalgam particles from the wastewater stream (DCN DA00163). EPA identified three major technologies that capture dental amalgam waste, in addition to chair-side traps and vacuum pump filters, before it is discharged to the POTW: Separators, ion exchange, and wastewater containment systems. EPA also identified BMPs that have a significant impact on dental amalgam discharges. mstockstill on DSK30JT082PROD with RULES 1. Amalgam Separators An amalgam separator is a device designed to remove solids from dental office wastewater. Amalgam separators remove amalgam particles from the wastewater through centrifugation, sedimentation, filtration, or a combination of any of these methods. Practically all amalgam separators on the market today rely on sedimentation because of its effectiveness and operational simplicity. The vast majority of amalgam separators on the market today have been evaluated for their ability to meet the current American National Standards Institute’s (ANSI) Standard for Amalgam Separators (ANSI/ADA Standard No. 108 for Amalgam Separators). This standard incorporates the International Organization for Standardization (ISO) Standard for Dental Amalgam Separators (http:// www.iso.org/iso/iso_catalogue/ catalogue_tc/catalogue_detail.htm ?csnumber=42288).3 The current ISO standard for amalgam separators is ISO 11143. ISO established a standard for measuring amalgam separator efficiency by evaluating the retention of amalgam solids using specified test procedures in a laboratory setting. In order to meet the ISO standard, a separator must achieve 95 percent removal or greater of total solids. The ISO standard also includes certain design requirements and requirements for instructions for proper use and maintenance. For example, for non-sedimentation amalgam separators, the ISO 11143 standard requires a warning system such as an auditory or visual sign to indicate when the separator’s efficiency is compromised to ensure that the operator is aware that the separator is not operating optimally. For sedimentation separators, the requirement can be met by providing instructions that would allow the 3 ANSI is the coordinator of the U.S. voluntary consensus standards system. An ISO document may be nationally adopted as an ANS as written or with modifications to its content that reflect technical deviations to the ISO standard that have been agreed upon through a consensus process. In other words, a consensus of U.S. experts, in an open and due process based environment, agreed that ISO 11143 with U.S. modifications is appropriate for adoption as an ANS. VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 operator to ascertain the operating status of the amalgam separator. Based on reported removal efficiencies of a range of amalgam separators currently on the market that meet the ISO standard, separators obtain a median of 99 percent removal efficiency (see Chapter 7 of the TEDD) of total dental solids. When existing chair-side traps and vacuum pump filters are used upstream of the amalgam separators, the combined treatment system can achieve total mercury removal rates exceeding 99 percent (DCN DA00008). Solids collected by the amalgam separator may be a combination of dental amalgam, biological material from patients, and any other solid material sent down the vacuum line. The collected solids must be handled in accordance with federal, state and local requirements. EPA regulates the disposal of mercury-containing hazardous waste under the Resource Conservation and Recovery Act (RCRA). A mercury-containing waste can be considered hazardous in two ways: (1) As a listed hazardous waste; or (2) as a characteristic hazardous waste. Unused elemental mercury being discarded would be a listed hazardous waste (waste code U151). Persons who generate hazardous waste, such as a waste that exhibits the hazardous characteristics for mercury, are subject to specific requirements for the proper management and disposal of that waste. The federal RCRA regulatory requirements differ depending upon how much hazardous waste a site generates per month. Most dental practices generate less than 100 kilograms of non-acute hazardous waste per month and less than 1 kilogram of acute hazardous waste per month. Such facilities are therefore classified as ‘‘Very Small Quantity Generators’’ (VSQGs). VSQGs are not subject to most of the RCRA hazardous waste requirements. Many states have additional requirements for the handling of mercury, including waste dental amalgam. Chapter 6 of the TEDD provides additional details on the handling requirements for states that require dentists to control dental mercury dischargers. To facilitate compliance with state and local requirements, several amalgam separator manufacturers offer services that facilitate the transport of waste amalgam to facilities that separate mercury from other metals in dental amalgam and recycle the mercury, keeping it out of the environment. EPA recommends that dental dischargers take advantage of such services. In 2012, PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 ADA posted a directory of amalgam recyclers on its Web site. See DCN DA00468. For more information about amalgam separators, see the proposed rule (79 FR 63265; October 22, 2014). 2. Polishing To Remove Dissolved Mercury From Wastewater Mercury from dental amalgam in wastewater is present in both the particulate and dissolved form. The vast majority (≤99.6 percent) is particulate (DCN DA00018). An additional process sometimes referred to as ‘‘polishing’’ uses ion exchange to remove dissolved mercury from wastewater. Dissolved mercury has a tendency to bind with other chemicals, resulting in a charged complex. Ion exchange is the process that separates these charged amalgam particles from the wastewater. For ion exchange to be most effective, the incoming wastewater must first be treated to remove solids. Then the wastewater needs to be oxidized (creating a charge on the amalgam particles) in order for the resin or mercury capturing material to capture the dissolved mercury. Therefore, ion exchange will not be effective without first being preceded by a solids collector and an oxidation process. The data available to EPA indicate that total additional mercury reductions with the addition of polishing are typically about 0.5 percent (DCN DA00164). This is not surprising since, as indicated above, dissolved mercury contributes such a small portion to the total amount of mercury in wastewater. In addition to polishing as described above, EPA is aware that vendors are developing amalgam separators with an improved resin for removing dissolved mercury. For additional discussion on polishing, see proposal (79 FR 63266; October 22, 2014). 3. Wastewater Retention Tanks Commenters on the proposed rule identified wastewater retaining tanks as a third technology to reduce mercury discharges from dental offices to POTWs. Where currently used, these systems collect and retain all 4 amalgam process wastewater. The wastewater remains in the wastewater retention tank until it is pumped out of the tank and transferred to a privately owned wastewater treatment facility. This eliminates the discharge of amalgam process wastewater and the associated 4 Dental offices using wastewater retention tanks must ensure that all amalgam process wastewater is collected by the wastewater retention tanks. Any uncollected amalgam process wastewater that is discharged to the POTW is subject to this rule. E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations pollutants from a dental office to a POTW. 4. Best Management Practices In addition to technologies, EPA also identified best management practices currently used in this industry (and included in the ADA BMPs) to reduce dental amalgam discharges. In particular, EPA identified two BMPs to control dental amalgam discharges that would not be captured by an amalgam separator and/or polishing unit. Oxidizing line cleaners can solubilize bound mercury. If oxidizing cleaners are used to clean dental unit water lines, chair side traps, or vacuum lines that lead to an amalgam separator, the line cleaners may solubilize any mercury that the separator has captured, resulting in increased mercury discharges. One BMP ensures the efficiency of amalgam separators by prohibiting use of oxidizing line cleaners including but not limited to, bleach, chlorine, iodine and peroxide, that have a pH lower than 6 or greater than 8.5 Flushing waste amalgam from chairside traps, screens, vacuum pump filters, dental tools, or collection devices into drains also presents additional opportunities for mercury to be discharged from the dental office. The second BMP prohibits flushing waste dental amalgam into any drain. VI. Final Rule mstockstill on DSK30JT082PROD with RULES A. Scope and General Applicability Consistent with the proposal, dental offices that discharge to POTWs are within the scope of this final pretreatment rule.6 EPA solicited information in the proposal from the public on its preliminary finding that, with few exceptions, dental offices do not discharge wastewater directly to surface waters. EPA did not receive any comments containing data to contradict this finding. Therefore, EPA is not establishing any requirements for direct wastewater discharges from dental offices to surface waters at this time. The final rule applies to wastewater discharges to POTWs from offices where the practice of dentistry is performed, including large institutions such as dental schools and clinics; permanent or temporary offices, home offices, and facilities; and including dental offices owned and operated by federal, state, or local governments including military 5 Many alternatives use enzymatic or other processes that do not lead to the dissolution of mercury when used to clean chairside traps, and vacuum lines. See DCN DA00215. 6 The final rule does not apply to dental discharges to septic systems. VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 27161 B. Existing Source (PSES) Option Selection After considering all of the relevant factors and dental amalgam management approaches discussed in this preamble and TEDD, as well as public comments, EPA decided to establish PSES based on proper operation and maintenance of one or more ISO 11143 7 compliant amalgam separators and two BMPs—a prohibition on the discharge of waste (or ‘‘scrap’’) amalgam to POTWs and a prohibition on the use of line cleaners that are oxidizing or acidic and that have a pH higher than 8 or lower than 6. EPA finds that the technology basis is ‘‘available’’ as that term is used in the CWA because it is readily available and feasible for all dental offices subject to this rule. Data in the record demonstrate that the technology basis is extremely effective in reducing pollutant discharges in dental wastewater to POTWs as the median efficacy of ISO compliant amalgam separators on the market in the U.S. is 99.3 percent. Moreover, ADA recommends that dentists use the technology on which this rule is based (ISO compliant amalgam separators and BMPs). Further, as described in Section III, EPA estimates that approximately 40 percent of dental offices potentially subject to this rule currently use amalgam separators on a voluntary basis or are in states or localities with laws requiring the use of amalgam separators. Many dentists have used amalgam separators and BMPs for at least a decade. For those dental offices that have not yet installed an amalgam separator, EPA estimates this is a lowcost technology with an approximate average annual cost of $800 8 per office. EPA’s economic analysis shows that this rule is economically achievable (see Section IX). Finally, EPA also examined the incremental non-water-quality environmental impacts of the final pretreatment standards and found them to be acceptable. See Section XII. EPA did not establish PSES based on technologies that remove dissolved mercury such as polishing. EPA is not aware of any state or local regulations that require ion exchange or that require removal of dissolved mercury. Commenters raised operational concerns with ion exchange citing a pilot study for the department of Navy. EPA also lacks adequate performance data to assess the efficacy of polishing for nationwide use. While even very small amounts of mercury have environmental effects, EPA lacks sufficient data to conclude that there is a significant difference in the performance between traditional amalgam separators and polishing. Moreover, current information suggests that polishing is not available for nationwide use because the typical dental office may not have adequate space to install the treatment train needed for effective polishing and because there are few polishing systems on the market today in comparison to traditional amalgam separators. Lastly, EPA estimates that the capital costs of the polishing system, as a stand-alone system, are approximately four times that of the amalgam separator even though the costs for chemical use, regenerating the resin, filter replacement, and other operational costs were not reported (DCN DA00122). These factors led EPA to find that polishing is not ‘‘available’’ as that term is used in the CWA. 7 ISO 11143 Standard as incorporated and updated by ANSI Standard 108 (ANSI 108/ISO 11143 Standard). 8 This estimate is based on the average annualized cost for dental offices that do not currently have an amalgam separator. See DCN DA00458. bases. The final rule does not apply to wastewater discharges from dental offices where the practice of dentistry consists exclusively of one or more of the following dental specialties: Oral pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, periodontics, or prosthodontics. As described in the TEDD, these specialty practices are not expected to engage in the practice of amalgam restorations or removals, and are not expected to have any wastewater discharges containing dental amalgam. The final rule also does not apply to wastewater discharges to POTWs from mobile units. EPA proposed to apply the standards to mobile units (typically a specialized mobile self- contained van, trailer, or equipment from which dentists provide services at multiple locations), soliciting comments and data pertaining to them (79 FR 63261; October 22, 2014). However, EPA is not establishing requirements for mobile units at this time because it has insufficient data to do so. EPA does not have, nor did commenters provide, data on the number, size, operation, or financial characteristics of mobile units. EPA also has minimal information on wastewater discharges from mobile units, and/or practices employed to minimize dental amalgam in such discharges. Therefore, any further evaluation of requirements for mobile units is not possible at this time, and the final rule requirements do not apply to mobile units. PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1 27162 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations EPA also did not establish PSES based on wastewater retention tanks. Capital costs for wastewater retention tanks are approximately twice that of the amalgam separator (DCN DA00461). EPA does not have information on the costs incurred by the dental office to send the collected wastewater off-site to a privately owned treatment facility (may also be referred to as a centralized waste treatment facility or CWT). Furthermore, wastewater retention tanks require space, and EPA determined that the typical dental office may not have adequate space to install the tanks. In addition, EPA is only aware of one vendor currently offering this technology and service combination (vendor transfers the collected wastewater to a privately owned treatment facility), and the vendor’s service area is limited to a few states. Therefore, EPA did not find this technology to be available to the industry as a whole. mstockstill on DSK30JT082PROD with RULES C. New Source (PSNS) Option Selection After considering all of the relevant factors and technology options discussed in this preamble and in the TEDD, as well as public comments, EPA decided to establish PSNS based on the same technologies identified above as PSES. As previously noted, under section 307(c) of the CWA, new sources of pollutants into POTWs must comply with standards that reflect the greatest degree of effluent reduction achievable through application of the best available demonstrated control technologies. Congress envisioned that new treatment systems could meet tighter controls than existing sources because of the opportunity to incorporate the most efficient processes and treatment systems into the facility design. The technologies used to control pollutants at existing offices, amalgam separators and BMPs, are fully available to new offices. In addition, data from EPA’s record show that the incremental cost of an amalgam separator compared to the cost of opening a new dental office is negligible; therefore, EPA determined that the final PSNS present no barrier to entry (see Section IX below). Similarly, because EPA projects that the incremental non-water quality environmental impacts associated with controls for new sources would not exceed those for existing sources, EPA concludes the non-water quality environmental impacts are acceptable. Therefore, this final rule establishes PSNS that are the same as those for PSES. EPA rejected other technologies as the basis for PSNS for the same reasons the VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 Agency rejected other technology bases for PSES. D. Requirements 1. Performance Standard EPA finalized the performance standards based on the same technology identified in the proposed rule, amalgam separators. EPA proposed a standard that would require dental dischargers to remove a specified percentage of total mercury from amalgam process wastewater and to follow the BMPs. Recognizing the impracticality of collecting and analyzing wastewater samples to demonstrate compliance with the standard for this industry, EPA included a provision by which dental offices could demonstrate compliance by certifying they were following the required BMPs and using an amalgam separator that achieved the specified percentage when tested for conformance with the ISO standard. EPA received comments regarding the proposed requirement. Commenters questioned the specified percent reduction, and raised concerns that the proposed standard could require dental offices to measure the percent removal being achieved by their amalgam separator, which was not the Agency’s intent. In response to these comments, the final rule specifies a performance standard— BMPs and the use of an amalgam separator(s) compliant with the ISO standard rather than specifying a numerical reduction requirement. The final rule also includes a provision such that the performance standard can be met with the use of an amalgam removing technology other than an amalgam separator (equivalent device). EPA included this provision to incorporate future technologies that achieve comparable removals of pollutants from dental discharges as amalgam separators but that may not fall under the amalgam separator classification. Because the rule does not include a numerical limit, the performance standards also specify certain operation and maintenance requirements for the amalgam separator or comparable device to ensure they are operated optimally. The final rule allows dental offices to continue to operate existing amalgam separators for their lifetime or ten years (whichever comes first), as long as the dental discharger complies with the other rule requirements including the specified BMPs, operation and maintenance, reporting, and recordkeeping requirements. Once the separator needs to be replaced or the ten-year period has ended, dental offices PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 will need to replace the amalgam separator with one that meets the requirements of the final rule. EPA does not want to penalize existing dental offices or institutional dental offices that have already installed amalgam separators voluntarily or to comply with state or local requirements. EPA recognizes that these offices may currently have amalgam separators in place that do not meet the ANSI ADA specification or the criteria of the ISO 11143 2008 standard. EPA did not want to establish a rule that would require dental offices with existing separators that still have a remaining useful life to be retrofitted with new separators, both because of the additional costs incurred by dental offices that adopted technology to reduce mercury discharges ahead of EPA’s requirements and because of the additional solid waste that would be generated by disposal of the existing separators. In addition to installing one or more amalgam separators compliant with the ISO 11143 standard (or its equivalent) and implementing the required BMPs, the pretreatment standards specify certain operating and maintenance requirements for the amalgam separator. For example, the final rule requires a documented amalgam separator inspection to ensure the separator is performing properly. As explained in Section V, malfunctioning separators or separators that have reached their capacity are ineffective. Therefore, in order to ensure that mercury is not discharged from the facility, it is important that dentists know the operational status of their amalgam separator (see 40 CFR 441.40(c)). As such, the final rule requires the separator to be inspected per the manufacturer’s instructions. In addition, as explained in Section V, the ISO standard specifies non-sedimentation separators must have a visual or auditory warning indicator when the separator is nearly full or operating in by-pass mode. While not required for sedimentation amalgam separators, some manufacturers of sedimentation amalgam separators include visual or auditory warning indicators. Because warning indicators make it easy to detect when the separator is not operating optimally, EPA encourages dental offices to select an amalgam separator with a warning indicator when installing a new amalgam separator. EPA is aware that some amalgam separator vendors (in addition to providing the needed equipment) or service providers offer service contracts to maintain the system. These vendors also typically provide waste E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations mstockstill on DSK30JT082PROD with RULES management services for the collected solids. Some vendors also provide the necessary documentation and reports required by existing state and local programs. EPA encourages but does not require dental offices to consider such services, as they may aid compliance with the rule. 2. Applicability to Dental Offices That Do Not Place or Remove Dental Amalgam In the final rule, dental dischargers that do not place dental amalgam, and do not remove dental amalgam except in limited emergency or unplanned, unanticipated circumstances are exempt from any further requirements as long as they certify such in their One-time Compliance Report to their Control Authority. In this way, if, over time, the use of dental amalgam is phased out as a restorative material, the requirements of this rule will no longer apply. By limited circumstances, EPA means, dental offices that remove amalgam at a frequency less than five percent of its procedures. As described below, based on the record, on average, this percent approximates to 9 removals per office per year (DCN DA00467). Dental amalgam traditionally has been used as a restorative material for cavities because the malleability of newly mixed amalgam makes it easy to place into cavities and because of its durability over time. While still used in many dental offices in the U.S., some dental offices have elected not to use dental amalgam and instead use only nonmercury based filling materials, such as composite resins and glass ionomer cements (DCN DA00495). As explained in Section IV, removed restorations are the largest contributor of mercury in dental discharges. Some dental offices have also elected not to remove amalgam restorations. EPA recognizes some dental offices only remove dental amalgam extremely infrequently, where there is an unplanned, unanticipated procedure. At the same time, for accepting new patients during the normal course of business, EPA would expect offices to inquire as to whether the patient has mercury fillings and not accept patients that have such fillings unless they install a separator or equivalent treatment in accordance with this rule. EPA proposed that dental offices that certify that they do not place or remove amalgam except in limited emergency circumstances would be exempt from any further requirements of the rule. EPA is clarifying in the final rule that the limited circumstances provision applies to the removal, but not to the placement of dental amalgam. A dental VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 office that stocks amalgam capsules clearly intends to place amalgam, and does not represent the type of limited circumstance this provision is intended to address. Commenters largely supported this approach, and most commenters suggested EPA define limited emergency circumstances. The frequency recommended by these commenters ranged from once a quarter to 96 times a year (DCN DA00467). EPA is including the limited circumstances provision in the final rule to allow a dental office that does not reasonably expect to place or remove dental amalgam to provide immediate treatment, such as where unplanned, unanticipated removal of the amalgam is necessary at that facility at that time, in the professional judgment of the dentist. EPA’s intent is to exclude dental offices from the rule’s requirements, other than a one-time report, for unplanned removals. In EPA’s view, dental offices that remove amalgam at a frequency more often than five percent of its procedures are not likely engaging in only limited, unplanned removals. EPA estimates that on average, a single chair dental office would remove amalgam 183 times per year (DCN DA00467). An amalgam removal rate that represents less than five percent of this frequency consists of approximately nine removals per year, on average, respectively. However, because EPA does not have, nor did commenters provide, data on the frequency of such unplanned and unanticipated instances nationwide, the final rule does not include a specific definition of limited circumstances. Rather, EPA expects a dental office to carefully consider its operation in light of the information provided above and only certify accordingly to their Control Authority if it meets the situation EPA described. 3. Dental Discharger Reporting and OnSite Paperwork Compliance Requirements Dental dischargers subject to this rule must comply with a one-time reporting requirement specified in the final rule in lieu of the otherwise applicable reporting requirements in 40 CFR part 403. Submission of reports as specified in this rule satisfies the reporting requirements in 40 CFR parts 403 and 441. For dental offices that do not place or remove dental amalgam except in limited circumstances, dental offices must submit a One-Time Compliance Report that includes information on the facility and a certification statement that the dental discharger does not place dental amalgam and does not remove amalgam except in limited PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 27163 circumstances. For dental offices that place or remove dental amalgam, the One-Time Compliance Report must include information on the dental facility and its operations and a certification that the dental discharger meets the requirements of the applicable performance standard. Dentists that utilize a third party to maintain their separator must report that information in their One-Time Compliance Report. Dentists that do not utilize a third party to maintain the amalgam separator(s) must provide a description of the practices employed by the office to ensure proper operation and maintenance. EPA suggests dental offices consider use of signs displayed prominently in the office or electronic calendar alerts to remind staff of dates to perform and document monthly inspections, cartridge replacement, etc. If a dental practice changes ownership (which is a change in the responsible party, as defined in 40 CFR 403.12(l)), the new owner must submit a One-Time Compliance Report that contains the required information. The One-Time Compliance Report must be signed by (1) a responsible corporate officer if the dental office is a corporation; (2) a general partner or proprietor if the dental office is a partnership or sole proprietorship; or (3) a duly authorized representative of the responsible corporate officer, or general partner or proprietor. This does not preclude a third party from submitting the report on behalf of a dental office as long as the submission also includes a proper signature as described above. The final rule does not require electronic reporting nor does it prevent electronic reporting. EPA received several comments requesting that EPA develop an electronic compliance reporting system as a part of this final rule. These commenters generally advocated for electronic reporting due to the size of the industry and the proposed annual reporting requirement. During development of the final rule, EPA considered several variations of requirements for dental dischargers to report electronically (which would have necessitated an electronic system). Most commonly, electronic systems are preferable when reports must be submitted on a periodic basis. EPA ultimately decided not to specify electronic reporting in the final rule after it determined the final rule would only require a one-time compliance report from each affected dental discharger. Still, EPA recognizes that some Control Authorities may prefer to receive the one-time reports electronically or to provide affected E:\FR\FM\14JNR1.SGM 14JNR1 27164 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations mstockstill on DSK30JT082PROD with RULES dental dischargers with the option to report electronically. EPA also recognizes that electronic submittal of required reports could increase the usefulness of the reports, is in keeping with current trends in compliance reporting, and could result in less burden on the regulated community and the Control Authorities. EPA may develop and make available, via its EEnterprise portal, an electronic reporting system that Control Authorities could use to facilitate the receipt of reports from dental dischargers, if they choose to do so. At some future date, EPA could decide to revise this final rule to require electronic reporting. If it chose to do so, EPA would first propose the revisions and provide an opportunity for public review and comment. Finally, the final rule requires dental offices to document certain operation and maintenance requirements and maintain all records of compliance, as described in the regulation, and to make them available for inspection. 4. Control Authority Oversight/ Reporting EPA proposed to amend selected parts of the General Pretreatment Regulations (40 CFR part 403) in order to simplify oversight requirements for the approximately 117,000 dental offices subject to the proposed rule. Specifically, EPA proposed to amend 40 CFR part 403 to create a new classification of categorical industrial users specifically tailored to pretreatment standards for dental offices, dental industrial user (DIU). EPA proposed that as long as a dental office complied with the requirements for DIUs, that it would not be considered an SIU. Among other things, this would have reduced the General Pretreatment Regulation oversight requirements for Control Authorities, such as the requirement to issue a control mechanism and annual inspection and sampling. EPA received numerous comments related to the proposed change, particularly from the Control Authorities. These commenters largely supported the reduced oversight requirements in the proposal, but encouraged EPA to reduce them further so that dental offices would never be SIUs, primarily due to concerns over the associated burden given the large number of dental offices potentially subject to the rule. In addition, Control Authorities raised concerns that they would have to update state and local laws to take advantage of the proposed changes to part 403 that would reduce the oversight requirements. They also VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 raised concerns about additional reporting requirements for the Control Authorities typically associated with CIUs, such as identifying CIUs in their annual pretreatment report to the Approval Authority. In response, EPA did not revise the General Pretreatment Standards to create the proposed DIU category and associated requirements. Rather, this rule establishes for the purposes of part 441, that dental dischargers are not SIUs or CIUs as defined in 40 CFR part 403 unless designated as such by the Control Authority. This regulatory structure achieves the same goal as the proposed revisions to the General Pretreatment Standards—simplification of oversight requirements—without creating a need for updates to state and local laws. By establishing that dental dischargers are not SIUs or CIUs in the final rule, EPA eliminates the application of specific oversight and reporting requirements in 40 CFR part 403 such as permitting and annual inspections of dental dischargers for SIUs and CIUs unless the Control Authority chooses to apply these requirements to dental offices. This means that Control Authorities have discretion under the final rule to determine the appropriate manner of oversight, compliance assistance, and enforcement.9 Further, the final rule reduced reporting for dental offices (and associated oversight requirements by Control Authorities) in comparison to reporting requirements for other industries subject to categorical pretreatment standards, as it requires only a One-Time Compliance Report be submitted to the Control Authority. The One-Time Compliance Report requirements specific to dental dischargers are included in this rule rather than in the General Pretreatment regulations so that they may be implemented directly. In summary, for this final rule, the Control Authorities must receive the One-Time Compliance Reports from dental dischargers and retain that notification according to the standard records retention protocol contained in § 403.12(o). Where EPA is the Control Authority, EPA expects to explore compliance monitoring approaches that support sector-wide compliance evaluations, to the extent practicable. States and POTWs that are the Control Authority may elect to use the same approach but are not required to do so. One approach may be periodic review and evaluation of nationwide data on releases of dental amalgam metals (e.g., mercury), relying 9 Nothing stated in this section shall be construed so as to limit EPA’s inspection and enforcement authority. PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 on Discharge Monitoring Reports from POTWs, Annual Biosolids Reports from POTWs, emissions data from sludge incinerators, and supplemental data submitted to EPA under the Toxic Releases Inventory program. EPA may utilize an approach to compliance inspections that focuses on a statistically valid sample of the regulated community. EPA may then use the inspection findings from such an approach to identify common areas of noncompliance, which would inform decisions about needed outreach, compliance assistance, and training materials. EPA will work with state and local Control Authorities, the ADA and other partners to tailor oversight and outreach to the issues where such oversight and outreach is most likely to achieve compliance across the dental sector. 5. Interaction With Existing State and Local Mandatory Dental Amalgam Reduction Programs The final rule applies to both dental offices that are subject to existing mandatory state or local dental amalgam reduction programs and those that are not. Some proposal commenters, many of whom are in states and localities with existing programs, questioned the application of this rule to dentists already subject to state and local programs noting the duplicative requirements. While EPA found that many of the existing programs contained at least one attribute of this final rule (e.g. separators, reporting, BMPs, operation and maintenance), the majority did not contain all of the attributes. Generally, the additional requirements (and associated costs) of this final rule are incremental over existing mandatory state or local dental amalgam reduction requirements. For example, a dentist located in a state or locality that does not require one or both of the BMPs specified in this rule must implement both BMPs. While the requirements of this rule are incremental to existing state and local regulatory requirements, EPA finds they are necessary to achieve the intended environmental objectives of the rule. Applying categorical pretreatment standards to pollutant discharges from dental offices irrespective of existing discharge requirements is consistent with the general approach to pretreatment standards under the CWA in that it establishes uniform requirements that form the floor of performance for all dischargers in a regulated category. In addition, requiring all dental offices to meet the same requirements, regardless of the applicability of other E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations mstockstill on DSK30JT082PROD with RULES state or local requirements, avoids substantial implementation challenges and potential confusion associated with alternative approaches. EPA considered several approaches for accommodating dentists in states and localities with existing and local requirements. For example, EPA considered exempting dentists subject to equivalent state and local requirements from the scope of this rule. EPA rejected this approach, in part, due to the complexities and potential confusion associated with evaluating and communicating the equivalency of state and local requirements to this rule, particularly as they may change over time. The rule establishes clear requirements for all parties and compliance with the final rule is simple and straightforward for dental offices and the regulating authorities. It requires dental offices to install and operate a separator, to implement two BMPs, and to submit a One-time Compliance Report to the Control Authority. Thereafter, the dental office will be required to conduct ongoing operation and maintenance and maintain associated records. These activities can be facilitated by third parties such as dental office suppliers and amalgam separator manufacturers. EPA does not expect the federal requirements to conflict with existing state or local mandatory amalgam reduction requirements. Rather, EPA concludes this final rule imposes only incremental additional requirements (e.g., one-time compliance report) to their Control Authority, if any, on dental offices already subject to state or local amalgam reduction requirements. For Control Authorities, because EPA significantly reduced the oversight requirements associated with this rule, the incremental costs and burden to apply the final rule’s requirements to dental facilities subject to some existing mandatory dental amalgam reduction requirements are minimal. The only incremental requirement associated with this rule is for the Control Authority to receive, review, and retain a One-time Compliance Report from dentists subject to this rule. 6. Variances The provision of this rule establishing that dental dischargers are not SIUs or CIUs unless designated as such by the Control Authority does not change the otherwise applicable variances and modifications provided by the statute. For example, EPA can develop pretreatment standards different from the otherwise applicable requirements for an individual existing discharger subject to categorical pretreatment VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 standards if it is fundamentally different with respect to factors considered in establishing the standards applicable to the individual discharger. Such a modification is known as a ‘‘fundamentally different factors’’ (FDF) variance. See 40 CFR 403.13 and the preamble to the proposed rule (79 FR 63278–63279, October 22, 2014). FDF variances traditionally have been available to industrial users subject to categorical pretreatment standards. Whether or not a dental discharger is an SIU or CIU, it is subject to categorical pretreatment standards and therefore eligible to apply for an FDF variance. E. Pollutants of Concern and Pass Through Analysis CWA section 301(b) directs EPA to eliminate the discharge of all pollutants where it is technologically available and economically achievable (after a consideration of the factors specified in section 304(b) of the Act). The first step in such an analysis is typically to identify Pollutants of Concern (POCs)— or the pollutants potentially regulated in the effluent guideline. For this rule, EPA identifies the primary metals in dental amalgam as pollutants of concern: Mercury, silver, tin, copper, and zinc. Generally, in determining whether pollutants pass through a POTW when considering the establishment of categorical pretreatment standards, EPA compares the median percentage of the pollutant removed by POTWs achieving secondary treatment with the median percentage of the pollutant removed by facilities meeting BAT effluent limitations. EPA deems a pollutant to pass through a POTW when the percentage removed by POTWs is less than the percentage removed by direct dischargers complying with BPT/BAT effluent limitations. In this manner, EPA can ensure that the combined treatment at indirect discharging facilities and POTWs is at least equivalent to that obtained through treatment by a direct discharger, while also considering the treatment capability of the POTW. In the case of this final rulemaking, where EPA is only developing pretreatment standards, EPA compares the POTW removals with removals achieved by indirect dischargers using the technology that otherwise satisfies the BAT factors. Historically, EPA’s primary source of POTW removal data is its 1982 ‘‘Fate of Priority Pollutants in Publicly Owned Treatment Works’’ (also known as the 50 POTW Study). This well documented study presents data on the performance of 50 POTWs achieving secondary treatment in removing toxic pollutants. As part of the development of ELGs for PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 27165 the Centralized Waste Treatment (CWT) Industry promulgated in December 2000, EPA developed and documented a methodology, including data editing criteria, to calculate POTW percent removals for various toxic pollutants from the data collected in the study. EPA provided the opportunity for public comment on the percent removal methodology and the resulting percent removals in the CWT proposal. EPA similarly used and presented this methodology and data in subsequent ELG proposals and final rules. Using its long-standing approach, for this final rule, EPA determined the median percent removal by POTWs achieving secondary treatment is 90.2 percent for total mercury, and 42.6 percent to 88.3 percent for the other pollutants of concern. As described above, the 50 POTW Study measured pollutant reductions on the basis of total metals. Total metals include particulate (suspended) and dissolved (soluble) forms of the metal. As discussed above, while mercury is present in dental amalgam in both the particulate and dissolved form, the vast majority (>99.6 percent) is particulate. While EPA does not have information on the distribution of the other metals, EPA reasonably assumes the same distribution for the other metals. Because secondary treatment technologies are not designed to remove dissolved metals, EPA assumes dissolved metals are not removed by POTWs and that the percent reductions for POTWs represent particulate reductions. To determine the median percent removal of the pollutants of concern by amalgam separators, EPA collected information on the efficacy of existing separators. EPA excluded those separators that did not meet the 2008 ISO standards. At proposal, EPA determined the median percent removal of total mercury to be 99.0 percent, which is the reported removal when testing each of the amalgam separators marketed in the U.S. as conforming to the ISO standard (DCN DA00233). Commenters noted that existing data on the effectiveness of separators is measured as a percent reduction in mass, reflecting the dental amalgam particulates (rather than total mercury) collected by the device. EPA agrees the ISO standard evaluates particulates from dental amalgam rather than total mercury, and has adjusted its terminology accordingly. Based on updated information in the record, EPA determined the median percent removal of particulates by amalgam separators that meet the 2008 ISO standards is 99.3 percent. As such, because the median E:\FR\FM\14JNR1.SGM 14JNR1 mstockstill on DSK30JT082PROD with RULES 27166 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations percent removal of amalgam separators exceeds the median percent removal of well-operated POTWs employing secondary treatment for mercury and the other POCs, EPA determines that mercury and the other POCs pass through. In addition to comments relating to dissolved mercury, EPA received other comments and data pertaining to the proposed median percent removal of ISO compliant amalgam separators. Some commenters supported the percentage identified in the proposal, noting that certain states require the same level of performance, or identifying separators documented as achieving or exceeding that removal efficiency. Other commenters questioned EPA’s use of the data collected when laboratories certify amalgam separators to meet the ISO standard. More specifically, they asserted that the 2008 ISO standard requires the removal efficiency of the amalgam separator to be at least 95 percent on a mass fraction basis and as such, the ISO standard is not a validated test for measuring higher efficiencies. These commenters offered no data to demonstrate that the reported removals in excess of 95 percent were inaccurate, nor did commenters provide other efficiency data for amalgam separators. As it represents the best data available for the final rule, EPA appropriately used the data as reported to estimate the efficacy of amalgam separators for these purposes. EPA notes that even if commenters correctly characterized the minimum percent removal efficiency of amalgam separators meeting the 2008 ISO standard as 95 percent, this is a higher removal rate than the median percent removal by POTWs for all POCs. Therefore, while EPA based its analysis in the final rule on the percent removals as reported, under either case, EPA determines that mercury and the other POCs pass through. Other commenters stated the 50 POTW Study data were old, and that current POTW removals are higher than 90 percent. Some provided case studies, many of which reflected POTWs with advanced treatment capabilities rather than secondary treatment. In particular, the National Association of Clean Water Agencies (NACWA) submitted data from a nationwide voluntary survey of its members regarding mercury reductions at POTWs. Based on its analysis of the data collected in this survey, NACWA calculated a three-year average removal efficiency of 94 percent.10 EPA notes 10 EPA notes that in conducting its pass through analysis, EPA calculates and compares median VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 that even if EPA were to accept these data and analyses as presented by NACWA without further review, it would confirm EPA’s conclusion that pass through of POCs occurs because this percentage is less than the median efficiency of 2008 ISO compliant amalgam separators of 99.3 percent. EPA, however, gave full consideration to the NACWA survey and subjected the mercury influent and effluent data from the 41 POTWs from that survey to similar review and data editing criteria as influent and effluent data collected for the 50 POTW Study. In this way, EPA attempted to give the NACWA data full and equal consideration as the historical data from the 50 POTW Study. EPA created a database of the raw data in order to conduct its analysis. (DCN DA00463). When EPA calculated the median percent removal of the non-edited raw data as submitted by NACWA, the median plant performance was 93.8 percent, with a range of 57.2 percent to 99.1 percent. In reviewing the data used in that calculation, EPA identified numerous data points that would not satisfy the data editing criteria applied in the 50 POTW Study, including data points representing combined data rather than raw data, order of magnitude outlier concentrations, and incorrectly reported units of measure. Other discrepancies between data and analyses from the 50 POTW Study and NACWA survey include upward bias of using data from voluntary respondents, representing non-detect influent concentrations as zero,11 inclusion of several POTWs using BNR (biological nutrient removal) and other advanced treatment expected to perform better than secondary treatment, overrepresentation of areas with existing dental amalgam reduction programs, and underrepresentation of certain geographical areas. Sensitivity analyses around these data are found in the record. (DCN DA00464). Consequently, for all of the reasons identified above, for this final rule, EPA finds that data from the 50 POTW Study continues to represent the best data available to determine the percent removed nationwide by well operated POTWs employing secondary treatment. Based on the information in its record percent removals rather than average percent removals. 11 EPA generally handles non-detect values in the reported data by replacing them with a value of one-half of the detection level for the observation that yielded the non-detect. This methodology is standard procedure for the ELG program as well as Clean Water Act assessment and permitting, Safe Drinking Water Act monitoring, and Resource Conservation and Recovery Act and Superfund programs; and this approach is consistent with previous ELGs. PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 including full consideration of comments, EPA appropriately concludes that the median percent removal of amalgam separators is higher than the median percent removal of POTWs for mercury and the other pollutants of concern. As such, EPA concludes mercury and the other POCs pass through. VII. Technology Costs This section summarizes EPA’s approach for estimating incremental compliance costs to implement changes associated with this rule, while the TEDD provides detailed information on the methodology. The costing methodology for the final rule is the same as that described in the proposal (79 FR 63269; October 22, 2014); however, EPA updated some of the specific data elements. EPA estimated compliance costs using data collected through EPA’s Health Services Industry Detailed Study (August 2008) [EPA– 821–R–08–014], a review of the literature, information supplied by vendors, and data submitted with comments on the proposed rule. In estimating the total cost of the regulatory options, EPA estimated costs for the following components: Capital costs and other one-time costs; installation costs; annual operation and maintenance costs; and recordkeeping and reporting costs. EPA incorporated information received in comments pertaining to specific elements of the cost analysis, resulting in an increase in the initial installation cost and a minor increase in the average costs of dental amalgam separators that meet the 2008 ISO standard. In addition, EPA adjusted the reporting and recordkeeping costs to reflect the final rule requirements. The cost estimates reflect the incremental costs attributed only to this final rule. For example, offices required by a state or local program to have an amalgam separator compliant with the 2008 ISO 11143 standard will not incur costs to retrofit a separator as a result of this rule. Others may certify that they do not place or remove amalgam. Such offices may still have costs under this final rule such as those associated with the one-time reporting requirement to certify that they do not place or remove amalgam. EPA’s cost methodology assumes dental offices would use the required BMPs in combination with 2008 ISO 11143 amalgam separators to comply with the rule. All final cost estimates are expressed in terms of 2016 dollars. EPA used a model office approach to calculate costs of this rule. Under this approach, EPA developed a series of model dental offices that exhibited the E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations typical characteristics of the regulated dental offices, and then calculated costs for each type of model office. EPA then determined how many of each model office accurately represented the full universe of affected offices. While this part of the methodology remains unchanged from the proposal, EPA updated the number of offices in each model to reflect current existing state and local programs and, in the case of very large offices, to reflect new data obtained in public comments on the number of clinics and schools subject to this rule. A. Costs for Model Dental Offices EPA used the model approach to estimate costs for offices that place or remove amalgam for this final rule. EPA developed compliance costs for seven models, where each model is based on the number of chairs in an office. The ranges for each model are as follows: 1 to 2 chairs, 3 chairs, 4 chairs, 5 chairs, 6 chairs, 7–14 chairs (average of 10 chairs), and 15 chairs. EPA developed the 15 chairs model specifically to represent large institutional offices. This is discussed separately below in Section VII.B. EPA developed two sets of costs for each model: One for offices that do not use an amalgam separator and one for offices that do use an amalgam separator. For those offices that currently do not use an amalgam separator, EPA estimated one-time and annual costs. One-time costs include purchase of the separator and installation, and preparation of the One-time Compliance Report. Annual costs, for those offices that do use an amalgam separator, include visual inspection, replacement of the amalgam-retaining unit (e.g., cartridge or filter), separator maintenance and repair, recycling (preparation and services), and recordkeeping. Recordkeeping costs include documentation of inspection, separator maintenance and repair, and recycling (preparation and services). EPA also estimated periodic recordkeeping costs associated with 27167 repairs and One-Time Compliance Reports for new offices, which are included in the total of recordkeeping costs. Annual costs also include a cost offset, reflecting a cost savings as a result of changes that occur in the dental office due to the final rule requirements. More specifically, EPA received data in comments that an amalgam separator would protect the vacuum system filter and impeller blade from small particles, resulting in less frequent replacement and servicing of these elements when an amalgam separator has been installed. In the final rule cost analysis, EPA accordingly reduced the overall operation and maintenance costs for those dental offices that do not already have an amalgam separator. This cost offset reflects the reduced cost to dental offices of servicing the vacuum system filter and impeller blade. A summary of costs for dental offices that do not currently use amalgam separators may be found in Tables VII–1 and VII–2, see the TEDD for more details. TABLE VII–1—SUMMARY OF ONE TIME MODEL FACILITY COSTS ($2016) FOR DENTAL OFFICES THAT DO NOT CURRENTLY USE AMALGAM SEPARATORS Number of chairs in the model dental office Cost element 3, 4, or 5 12 1 or 2 Separator Purchase ............................................................. Installation ............................................................................ One-Time Compliance Report ............................................. $437 235 23 6 $697 276 23 7 to 14 $1,058 276 23 $1,291 358 23 15 $2,424 942 23 TABLE VII–2—SUMMARY OF ANNUAL MODEL FACILITY COSTS ($2016) FOR DENTAL OFFICES THAT DO NOT CURRENTLY USE AMALGAM SEPARATORS Number of chairs in the model dental office Cost element 3, 4, or 5 13 1 or 2 mstockstill on DSK30JT082PROD with RULES Replacement Parts .............................................................. Separator Maintenance ........................................................ Maintenance Cost Off-set .................................................... Recycling .............................................................................. Visual Inspection .................................................................. Recordkeeping ..................................................................... $275 115 ¥75 91 18 62 6 $386 115 ¥75 91 18 62 7 to 14 $559 115 ¥75 91 18 62 $732 115 ¥75 91 18 62 15 $1,078 115 ¥75 91 18 62 For those offices that already have an amalgam separator, EPA calculated costs for certain incremental annual costs associated with the amalgam separator required for this rule. Because these offices have separators, EPA only included a one-time cost for a One-Time Compliance Report ($23/office). Annual costs for such offices include visual inspection, replacement of the amalgamretaining unit, separator maintenance and repair, recycling (preparation and services), and recordkeeping. Because these offices have amalgam separators in place, they are already incurring the majority of these costs irrespective of this final rule. As such, for those components (e.g., replacement of the cartridge and operation and maintenance), EPA calculated their incremental costs as a portion (percentage) of annual costs for dental offices without technology in place. Recordkeeping costs include documentation of inspection, separator maintenance and repair, and recycling (preparation and services). EPA also estimated periodic recordkeeping costs associated with repairs and One-Time Compliance Reports for new offices, which are included in the total of recordkeeping costs. EPA did not include the cost offset in this model, as 12 EPA assumed the separator can be sized for 3, 4, or 5 chairs, but has kept these three model office sizes distinct because the economic analysis evaluates different revenues for each of these sized offices. 13 EPA assumed the separator can be sized for 3, 4, or 5 chairs, but has kept these three model office sizes distinct because the economic analysis evaluates different revenues for each of these sized offices. VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1 27168 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations described above. A summary of these annual costs may be found in Table VII– 3, see the TEDD for more details. TABLE VII–3—SUMMARY OF ANNUAL MODEL FACILITY COSTS ($2016) FOR DENTAL OFFICES THAT CURRENTLY USE AMALGAM SEPARATORS Number of chairs in the model dental office Cost element 3, 4, or 5 14 1 or 2 Replacement Parts .............................................................. Separator Maintenance ........................................................ Recycling .............................................................................. Inspection ............................................................................. Recordkeeping ..................................................................... In assessing the long term costs of rule compliance for these model offices (those with and without existing separators), EPA assumed that amalgam separators would have a service life of 10 years, at which time the amalgam separators would need to be replaced (DCN DA00163). Furthermore, the cost model assumes all dental amalgam separators installed prior to this rule would need to be replaced within 10 years of the effective date of this rule. Therefore, for the purposes of estimating compliance costs, EPA assumed that all offices subject to this rule would incur the cost of installing a new amalgam separator 10 years after the effective date of this rule. However, because various modifications needed by the office for initial amalgam separator installation would have already been completed, EPA has projected the installation costs for amalgam separators would be one-half of the cost of the original installation. EPA assumed that all dental offices would continue to incur recurring expenses such as O&M beyond year 10 in the same way as described for the initial installation. To the extent dental offices either close or certify they no longer remove or place amalgam, the costs are likely overstated. EPA projects that there will be no incremental costs associated with the required BMPs because (1) costs for non-oxidizing, pH neutral line cleaners are roughly equivalent to other line cleaners; and (2) dental offices will not incur additional costs by changing the location for flushing waste amalgam. mstockstill on DSK30JT082PROD with RULES B. Costs for Larger Institutional Dental Offices Institutional dental offices (e.g., military clinics or dental schools) have a larger number of chairs than the typical dental office. For these 14 EPA assumed the separator can be sized for 3, 4, or 5 chairs, but has kept these three model office sizes distinct because the economic analysis evaluates different revenues for each of these sized offices. VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 $138 58 45 18 62 $193 58 45 18 62 institutional dental offices, EPA developed a costing methodology based on the methodology for offices described above. For purposes of costs, consistent with the proposal, EPA assumed the average institutional office has 15 chairs.15 As shown in Chapter 9 of the TEDD, EPA has cost information for five amalgam separators that have a maximum design ranging from 17–22 chairs. EPA also has costs for a unit that can be custom sized for chair sizes of 16 or greater. EPA used the information for these six separators to estimate costs for institutional facilities. See DCN DA00454. These costs are likely overstated as they do not reflect opportunities the largest offices may have to share costs,16 and they do not assume any economies of scale. In addition, it is possible that the largest offices have multiple plumbing lines, allowing the installation of dental amalgam separators (or equivalent devices) only for those chairs used for placing or removing amalgam. See the proposed preamble and the TEDD for additional details on the costing methodology for institutional offices. VIII. Pollutant Loads As was the case for costing, EPA does not have office-specific discharge data for the approximately 117,000 dental offices potentially subject to this rule. Instead, EPA modeled the baseline, prerule discharges of mercury based on nationwide estimates of amalgam restorations and removals, and did not calculate the pollutant reductions on a per office basis. Rather, EPA calculated average mercury loadings by dividing the total number of annual procedures 15 This represents the number of chairs that can be used for the placement and/or removal of amalgam at a particular location. EPA received comments for institutional facilities indicating they had 7, 15, or 25 chairs. EPA selected the median of these values for purposes of this analysis. 16 For example, multiple offices located in a single building or complex may be able to share plumbing, vacuum systems, and may be able to install a larger separator rather than each office having its own separator. PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 6 7 to 14 $280 58 45 18 62 $366 58 45 18 62 15 $539 58 45 18 62 by the total number of dentists performing the procedure.17 The technology basis used to estimate the compliance costs of this rule includes 2008 ISO 11143 amalgam separators available on the market today, and certain BMPs. The median performance of these separators is 99.3 percent. EPA assumes all offices have chair-side traps or a combination of chair-side traps and vacuum filters that result in 68 percent and 78 percent collection of dental amalgam, respectively (DCN DA00163). After accounting for mercury reductions achieved through existing chair-side traps and vacuum pump filters, EPA’s analysis reduces remaining mercury loads to reflect the combination of chairside traps, vacuum filters, and amalgam separators. Therefore, EPA assumed a post-rule reduction in mercury loads to POTWs based on a 99.8 percent removal rate. This is the same approach and data that EPA presented in the proposal (79 FR 623275; October 22, 2014). Amalgam is comprised of roughly 49 percent mercury, 35 percent silver, 9 percent tin, 6 percent copper and 1 percent zinc (DCN DA00131). As explained earlier in Section VI, EPA concludes that the technology basis would be equally effective in reducing discharges of silver, tin, copper, and zinc as it is in reducing mercury. EPA therefore applied the same approach to estimating reductions of other metals found in dental amalgam. In other words, EPA assumes chair-side traps and the combination of chair-side traps and vacuum filters will result in 68 percent and 78 percent collection of these metals, respectively. Remaining amalgam metals are further reduced by an amalgam separator, as discussed above. 17 Because this approach is based on the number of dentists, it includes those dentists both at offices and institutional offices. E:\FR\FM\14JNR1.SGM 14JNR1 27169 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations A. National Estimate of Annual Pollutant Reductions to POTWs Associated With This Rule 18 1. Mercury EPA estimates the approximately 55,000 offices that install separators would obtain 99.3 percent removal of particulate mercury through the use of amalgam separators (median removal efficiency of amalgam separators; see Chapter 7 of the TEDD). This would result in reduction of particulate mercury discharges to POTWs by approximately 5.1 tons. Amalgam separators are not effective in removing dissolved mercury. However, dissolved mercury accounts for much less than 1 percent of the total mercury, so the form of mercury removed from discharges to POTWs is assumed to consist of particulate (solids) only. 2. Other Metals As explained earlier in Section VI, EPA concludes that the technology basis for this final rule would be equally effective in reducing discharges of silver, tin, copper, and zinc as it is in reducing mercury. Accordingly, EPA estimates a reduction of these metal discharges to POTWs of approximately 5.3 tons. 3. Total Reductions EPA estimates this final rule would annually reduce particulate mercury and other metal particulate discharges by a total of 10.3 tons. B. National Estimate of Annual Pollutant Reductions to Surface Waters Associated With This Rule In order to evaluate final discharges of mercury (and other metals) to waters of the U.S. by the POTW, EPA used its 50 POTW Study to calculate POTW removals of each metal. As explained above, at baseline and prior to implementation of this rule, EPA estimates 5.1 tons of dental mercury particulates are collectively discharged annually to POTWs. Based on the 50 POTW Study, EPA estimates POTWs remove 90.2 percent of dental mercury from the wastewater. Thus, POTWs collectively discharge 1,003 pounds of mercury from dental amalgam to surface waters annually. Under this final rule, 99.8 percent of mercury particulates currently discharged annually to POTWs will be removed prior to the POTW. The POTWs then further remove 90.2 percent of the remaining particulate mercury from the wastewater. This reduces the total amount of dental mercury particulates discharged from POTWs nationwide to surface water to 11 pounds of mercury annually. In other words, discharges of dental mercury to waters of the U.S. from POTWs are expected to be reduced by 992 pounds per year.19 Similarly, EPA’s 50 POTW Study data shows 42.6 percent to 88.3 percent of other metals in the wastewater are removed by POTWs. As explained above, EPA estimates 5.3 tons of other metals are also collectively discharged annually from dental offices to POTWs. Thus, POTWs collectively discharge approximately 2,178 pounds of other dental metals to surface waters annually. Following compliance with this rule, the total amount of other dental metal discharges from POTWs nationwide to surface waters will be approximately 24 pounds or a reduction of 2,153. See Chapter 11 of the TEDD for more details. IX. Economic Impact Analysis This section summarizes EPA’s assessment of the total annual costs and impacts of the final pretreatment standards on the regulated industry. A. Social Cost Estimates As described earlier in Section VI of this preamble, EPA based the technology standard for the final rule on a widely available technology, amalgam separators, and employment of readily available BMPs. Section VII provides a detailed explanation of how EPA estimated compliance costs for model dental offices. As applicable, EPA annualized the capital costs over a 20year period at a discount rate of 7 percent and 3 percent 20 and summed these costs with the O&M and reporting/ recordkeeping costs to determine an annual compliance cost estimate for each model facility. See the TEDD for more details. In order to develop a national estimate of social costs 21 based on these model offices, EPA estimated the number of dental offices represented by each model office. EPA categorized dental offices based on the number of chairs in each office.22 The 2012 Economic Census does not provide information on the distribution of dental offices by the number of chairs in each office. However, two studies, the ADA National Study and a Colorado Study, estimate distribution of dentist offices by number of chairs (DCN DA00141 and DCN DA00149). EPA used these two data sources to correlate the number of chairs per office to the revenue range of dental offices. EPA averaged the correlation of these two studies to estimate the number of dental offices by the number of chairs. The results are reported in table IX–1: TABLE IX–1—NUMBER OF DENTAL OFFICES BY NUMBER OF CHAIRS Number of offices by chair size Number of chairs ADA survey mstockstill on DSK30JT082PROD with RULES 1–2 chairs .................................................................................................................................... 3 chairs ........................................................................................................................................ 4 chairs ........................................................................................................................................ 5 chairs ........................................................................................................................................ 6 chairs ........................................................................................................................................ 7+ chairs ...................................................................................................................................... 18 EPA’s approach is not dynamic, as it does not account for declining use of dental amalgam. See additional discussion in V.B. 19 Dissolved mercury accounts for a portion of surface water discharges, because amalgam separators do not remove dissolved mercury. 20 See the TEDD for the reported analyses using both a 7 percent and 3 percent discount rate. VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 21 Costs of the rule, from the standpoint of cost to society, include compliance costs and administrative costs to Control Authorities. Social costs would also incorporate any adjustment based on a quantity demand response to a change in price driven by a price change due to cost pass-through to consumers. For this analysis, EPA is not able to demonstrate an observable change in price for PO 00000 Frm 00065 Fmt 4700 Sfmt 4700 16,606 57,841 ........................ 35,638 ........................ 23,136 Colorado survey 12,976 33,738 38,928 19,032 7,786 20,762 Average 14,791 31,329 33,924 18,425 12,802 21,949 dental services, therefore no observable change in amount of visits (quantity demanded). Therefore, EPA makes no adjustment to social costs based on a change in quantity. 22 Amalgam separators are typically designed based on the number of chairs. E:\FR\FM\14JNR1.SGM 14JNR1 27170 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations TABLE IX–1—NUMBER OF DENTAL OFFICES BY NUMBER OF CHAIRS—Continued Number of offices by chair size Number of chairs ADA survey Total ...................................................................................................................................... them costs for a baseline-compliance report. EPA then summed the values for each chair range over the number of chair ranges to yield the total estimated compliance cost. Similarly, EPA calculated costs for institutional offices by multiplying the compliance cost for its model institutional offices (15-chair model) by the number of estimated institutional offices indicated in Section To estimate nationwide social costs, EPA multiplied the estimated total annualized costs of rule compliance for each model office by the estimated number of dental offices represented by that model (i.e. with the indicated number of chairs and with/without existing amalgam separators). In EPA’s analysis, for dental offices that do not place or remove amalgam, EPA assigned Colorado survey 133,221 133,221 Average 133,221 V. Lastly, EPA estimated costs for Control Authorities to administer the final rule. Details of this cost analysis can be found in the TEDD. See Table IX–2 for EPA’s estimate of total nationwide annualized social costs for this final rule using a 3 percent discount rate.23 TABLE IX–2—TOTAL ANNUALIZED SOCIAL COSTS BY NUMBER OF CHAIRS [Millions of 2016 dollars] Total annualized costs by chair size 1 Number of chairs Colorado survey ADA survey 1–2 chairs ................................................................................................................................................................ 3 chairs .................................................................................................................................................................... 4 chairs .................................................................................................................................................................... 5 chairs .................................................................................................................................................................... 6 chairs .................................................................................................................................................................... 7–14 chairs .............................................................................................................................................................. 15 chairs .................................................................................................................................................................. Cost to Control Authorities ...................................................................................................................................... $4.2 13.6 15.7 7.7 4.0 13.1 0.3 0.8 $5.4 23.3 ........................ 16.4 ........................ 14.6 0.3 0.8 Total Annualized Social Costs ......................................................................................................................... 59.4 60.8 1 These costs reflect estimated costs discounted to the year of promulgation. EPA assumed that initial capital outlays and initial incurrence of ongoing compliance expenses would occur in the third year following rule promulgation. EPA assumed that the amalgam separator technology would have a service life of 10 years, and used a 20-year analysis period to allow for one-time replacement of capital equipment 10 years following the initial installation. A 3 percent discount rate was used for the analysis reported in this table; see the TEDD for the analysis reported with a 7% discount rate. EPA devised a set of tests for analyzing economic achievability. As is often EPA’s practice, the Agency conducted a cost-to-revenue analysis to examine the relationship between the costs of the rule to current (or pre-rule) dental office revenues as a screening analysis. In addition, EPA chose to examine the financial impacts of the rule using two measures that utilize the data EPA has on dental office baseline assets and estimated replacement capital costs: (1) Ratio of the Final Rule’s Capital Costs to Total Dental Office Capital Assets and (2) Ratio of the Final Rule’s Capital Costs to Annual Dental Office Capital Replacement Costs. EPA did not conduct a traditional closure analysis for this final rule because EPA does not have detailed data on baseline financial conditions of dental offices. Also, closure analyses typically rely on accounting measures such as present value of after-tax cash flow, and such accounting measures are difficult to implement for businesses that are organized as sole proprietorships or partnerships, as typically is the case in the dental industry. EPA considered whether it should exclude these offices from the analyses, which is described further in EPA’s proposal (79 FR 63272; October 22, 2014). Because EPA did not receive any comments to the contrary, EPA used the same assumptions for this final rule as it did at proposal with regard to lowrevenue offices. EPA concluded that offices making less than $25,400 were baseline closures as traditionally accounted for in cost and economic 23 As a point of clarification, social costs equal the sum of compliance costs and administrative costs. Also, EPA used a 3 percent discount rate for the social costs analysis. mstockstill on DSK30JT082PROD with RULES B. Economic Impact VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4700 Sfmt 4700 impact analysis for effluent guidelines rulemakings. Using the Economic Census, EPA estimated that to be approximately 531 offices. Still, because of the uncertainty here, EPA analyzed the impacts twice: (1) Excluding dental offices that could represent baseline closures and (2) including all offices in the analysis. For each of the three analyses conducted below, EPA used the same methodology for the final rule’s impact analysis as described in the proposal because EPA did not receive any comments to suggest a different approach for each impact analysis. Lastly, EPA used a 7 percent discount rate for the costs used in these three analyses described below. See the proposed rule for further description of the analyses below (79 FR 63272; October 22, 2014). E:\FR\FM\14JNR1.SGM 14JNR1 27171 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations 1. Cost-to-Revenue Analysis To provide an assessment of the impact of the rule on dental offices, EPA used a cost-to-revenue analysis as is standard practice when looking at impacts to small businesses under the Regulatory Flexibility Act (RFA) to determine if a rule has the potential to have a significant impact on a substantial number of small entities. The cost-to-revenue analysis compares the total annualized compliance cost of each regulatory option with the revenue of the entities. EPA estimated the occurrence of annualized compliance costs exceeding the 1 percent and 3 percent of revenue thresholds for the final rule twice: (1) Excluding dental offices that could represent baseline closures (excluding baseline set-aside offices), and (2) including all offices in the analysis (including baseline set-aside offices). Table IX–3 summarizes the results from this analysis. As shown there, under either scenario, over 99 percent of dental offices subject to this rule would incur annualized compliance costs of less than 1 percent of revenue. With baseline set-asides excluded from the analysis, 808 offices (0.7 percent of offices using dental amalgam and exceeding the set-aside revenue threshold) are estimated to incur costs exceeding 1 percent of revenue; no offices are estimated to incur costs exceeding 3 percent of revenue. With baseline set-asides included in the analysis, 1,217 offices (1 percent of offices using dental amalgam) are estimated to incur costs exceeding 1 percent of revenue; 174 offices (0.1 percent of offices using dental amalgam) are estimated to incur costs exceeding 3 percent of revenue. TABLE IX–3—COST-TO-REVENUE ANALYSIS IMPACT SUMMARY Total offices by chair size Number of chairs Costs >1% revenue Number Costs >3% revenue Percent Number Percent Excluding Baseline Set-Aside Offices from Analysis 1–2 chairs ............................................................................ 3 chairs ................................................................................ 4 chairs ................................................................................ 5 chairs ................................................................................ 6 chairs ................................................................................ 7–14 chairs .......................................................................... 12,914 27,353 29,619 16,087 11,177 19,163 808 0 0 0 0 0 6.3 0.0 0.0 0.0 0.0 0.0 0 0 0 0 0 0 0.0 0.0 0.0 0.0 0.0 0.0 Total .............................................................................. 116,313 808 0.7 0 0.0 Including Baseline Set-Aside Offices in Analysis 1–2 chairs ............................................................................ 3 chairs ................................................................................ 4 chairs ................................................................................ 5 chairs ................................................................................ 6 chairs ................................................................................ 7–14 chairs .......................................................................... 12,914 27,353 29,619 16,087 11,177 19,163 1,217 0 0 0 0 0 9.4 0.0 0.0 0.0 0.0 0.0 174 0 0 0 0 0 1.4 0.0 0.0 0.0 0.0 0.0 Total .............................................................................. 116,313 1,217 1.0 174 0.1 2. Ratio of the Rule’s Capital Costs to Total Dental Office Capital Assets This ratio examines the initial spending on capital costs of compliance in relation to the baseline value of assets on the balance sheet of dental office businesses. EPA assumes a low ratio implies limited impact on dental offices’ ability to finance the initial spending on capital costs of the final rule. A high ratio may still allow costs to be financed but could imply a need to change capital planning and budgeting. Table IX–4 reports the findings from this analysis, specifically the weighted average of the initial spending on the proposed rule’s capital costs divided by total assets of dental office across the revenue range/number-of-chairs analysis combinations. With baseline set-asides excluded from the analysis, the resulting initial capital costs to total capital assets values are low, with an average value 0.4 percent to 0.7 percent for the no technology in-place case and zero percent for the technology in-place case. With baseline closures included in the analysis, the resulting initial capital costs to total capital assets values are low, with an average value 0.4 percent to 0.7 percent for the no technology inplace case and 0 percent for the technology in-place case. TABLE IX–4—INITIAL SPENDING AS PERCENTAGE OF PRE-RULE TOTAL DENTAL OFFICE CAPITAL ASSETS1 Technology in place No technology in place Number of chairs mstockstill on DSK30JT082PROD with RULES Low High Low High Excluding Baseline Set-Aside Offices from Analysis 1–2 chairs ........................................................................................................ 3 chairs ............................................................................................................ 4 chairs ............................................................................................................ 5 chairs ............................................................................................................ 6 chairs ............................................................................................................ 7–14 chairs ...................................................................................................... VerDate Sep<11>2014 18:14 Jun 13, 2017 Jkt 241001 PO 00000 Frm 00067 Fmt 4700 Sfmt 4700 0.1 0.0 0.0 0.0 0.0 0.0 E:\FR\FM\14JNR1.SGM 0.0 0.0 0.0 0.0 0.0 0.0 14JNR1 2.4 0.9 0.6 0.3 0.3 0.2 1.2 0.5 0.4 0.2 0.2 0.1 27172 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations TABLE IX–4—INITIAL SPENDING AS PERCENTAGE OF PRE-RULE TOTAL DENTAL OFFICE CAPITAL ASSETS1—Continued Technology in place No technology in place Number of chairs Low Weighted Average ........................................................................................... High 0.0 Low High 0.0 0.7 0.4 0.0 0.0 0.0 0.0 0.0 0.0 0.0 3.0 0.9 0.6 0.3 0.3 0.2 0.7 1.5 0.5 0.4 0.2 0.2 0.1 0.4 Including Baseline Set-Aside Offices in Analysis 1–2 chairs ........................................................................................................ 3 chairs ............................................................................................................ 4 chairs ............................................................................................................ 5 chairs ............................................................................................................ 6 chairs ............................................................................................................ 7–14 chairs ...................................................................................................... Weighted Average ........................................................................................... 0.1 0.0 0.0 0.0 0.0 0.0 0.0 1 EPA used the baseline asset value for the minimum (reported as low) and maximum (reported as high) revenue values by number-of-chairs category as the denominator for the ratio. Total final rule compliance costs, as described in Section IX above, were assigned to each number-ofchairs category as the numerator for the ratio. 3. Comparison of the Rule’s Capital Costs to Annual Dental Office Capital Replacement Costs EPA also compared the initial spending on capital costs of compliance associated with this rule to the estimated capital replacement costs for a dental office business (e.g., computer systems, chairs, x-ray machines, etc.) across all chair sizes. The capital replacement costs represent a value that dental offices may reasonably expect to spend in any year to replace and/or upgrade dental office capital equipment. EPA assumes a low ratio implies limited impact on dental offices’ ability to finance the initial spending on capital costs of the final rule. A high ratio may still allow costs to be financed but could imply a need to change capital planning and budgeting. As expected, the results for this ratio are higher than the previous ratio in the test above, given that EPA expects replacement costs would be smaller than total capital assets. EPA performed this test because this ratio is based on a different data source, and so it provides an independent check that abstracts from the limitations of the data used in the test above. The resulting values for the final rule range from 2.0 percent to 2.8 percent, with a weighted average of 2.4 percent across all chair size ranges. mstockstill on DSK30JT082PROD with RULES TABLE IX–5—INITIAL SPENDING AS PERCENTAGE OF ESTIMATED ANNUAL DENTAL OFFICE CAPITAL REPLACEMENT COSTS 1 Number of chairs Percent 1–2 chairs ..................................... 3 chairs ......................................... 4 chairs ......................................... 5 chairs ......................................... 6 chairs ......................................... 7 chairs ......................................... VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 2.7 2.8 2.3 2.0 2.3 2.5 achievable, EPA finds the rule would TABLE IX–5—INITIAL SPENDING AS PERCENTAGE OF ESTIMATED AN- similarly be achievable for large NUAL DENTAL OFFICE CAPITAL RE- institutional offices. EPA determined that the final PLACEMENT COSTS 1—Continued pretreatment standard for new sources will not be a barrier to entry. EPA relied Number of chairs Percent on data describing the equipment needs 8 chairs ......................................... 2.3 and costs for starting a dental practice 9 chairs ......................................... 2.1 as compiled in Safety Net Dental Clinic Weighted Average ........................ 2.4 Manual, prepared by the National Maternal & Child Oral Health Resource 1 EPA estimated capital replacement costs, accounting for the total value of equipment Center at Georgetown University (see purchases for different numbers of chairs, and DCN DA00143). Information from the the composition of purchases by equipment Georgetown Manual demonstrates that life category by number-of-chairs as the de- the amalgam separator capital costs nominator for the ratio. EPA assigned total final rule compliance costs, as described (based on costs for existing model above in Section IX, to each number-of-chairs offices as described in Section VII) as the numerator for the ratio. comprised 0.2 percent to 0.3 percent of the cost of starting a dental practice as C. Economic Achievability shown in Table IX–6 and, therefore, The analyses performed above inform does not pose a barrier to entry. the potential economic impact of this TABLE IX–6—INITIAL SPENDING AS final rule on the dental office sector. In PERCENTAGE OF ESTIMATED DENTAL the cost-to-revenue analysis, EPA found OFFICE START-UP COSTS that no more than 0.1 percent of offices, mostly in the lower revenue ranges, Number of chairs Percent would potentially incur costs in excess of 3 percent of revenue. The two 1–2 chairs ..................................... 0.3 financial ratios reported in Tables IX–3 3 chairs ......................................... 0.3 and IX–4 show that the final rule will 4 chairs ......................................... 0.3 not cause dental offices to encounter 5 chairs ......................................... 0.2 difficulty in financing initial spending 6 chairs ......................................... 0.3 7 chairs ......................................... 0.3 on capital costs of the final rule. Based 8 chairs ......................................... 0.3 on the combined results of the three 0.3 analyses and that EPA had no data since 9 chairs ......................................... Weighted Average ........................ 0.3 proposal to suggest otherwise, EPA determined that the final rule is X. Cost-Effectiveness Analysis economically achievable. Regarding large offices, EPA notes that, due to a EPA often uses cost-effectiveness lack of data, the economic impact analysis in the development and analyses did not include large revision of ELGs to evaluate the relative institutional offices. EPA did not receive efficiency of alternative regulatory comments indicating large offices would options in removing toxic pollutants be impacted more or less than other from effluent discharges to our nation’s dental offices subject to this rule. Given waters. Although not required by the the results of the economic analysis CWA, and not a determining factor for performed on a range of office sizes establishing PSES or PSNS, costindicating that the rule is economically effectiveness analysis can be a useful PO 00000 Frm 00068 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations tool for describing regulatory options that address toxic pollutants. EPA defines the cost-effectiveness of a regulatory option as the incremental annual cost (in 1981 constant dollars to facilitate comparison to ELGs for other industrial categories promulgated over different years) per incremental toxicweighted pollutant removals for that option. For more information about the methodology, data, and results, see Chapter 12 of the TEDD. EPA determines toxic-weighted pollutant removals for a particular pollutant by multiplying the number of pounds of a pollutant removed by an option by a toxic weighting factor (TWF). The toxic weighting factor for each pollutant measures its toxicity relative to copper,24 with more toxic pollutants having higher toxic weights. The use of 27173 The costs used in the costeffectiveness analyses are the estimated annual pre-tax costs described in Section IX, restated in 1981 dollars as a convention to allow comparisons with the reported cost effectiveness of other effluent guidelines. Collectively, the final PSES requirements have a costeffectiveness ratio of $190–$195/lbequivalent as shown in Table X–2 below. This cost-effectiveness ratio falls TABLE X–1—TOXIC WEIGHTING FAC- within the range of cost-effectiveness TORS FOR POLLUTANTS IN DENTAL ratios for PSES requirements in other industries. A review of approximately AMALGAM 25 of the most recently promulgated or revised categorical pretreatment Mercury ................................. 110 standards shows PSES cost-effectiveness Silver ..................................... 16.47 ranges from less than $1/lb-equivalent Tin ......................................... 0.301 (Inorganic Chemicals) to $380/lbCopper .................................. 0.623 equivalent (Transportation Equipment Zinc ....................................... 0.047 Cleaning) in 1981 dollars. toxic weights allows EPA to express the removals of different pollutants on a constant toxicity basis as toxic-poundequivalents (lb-eq). In the case of indirect dischargers, the removal also accounts for the effectiveness of treatment at POTWs and reflects the toxic-weighted pounds after POTW treatment. The TWFs for the pollutants of concern are shown in Table X–1. TABLE X–2—PSES COST EFFECTIVENESS ANALYSIS Pre-tax total annualized costs ($1981 M) Final option Colorado Survey .......................................................................................................................... ADA National Survey ................................................................................................................... 123,552 123,552 Average cost effectiveness $190 195 A. Environmental Impacts EPA conducted a literature review concerning potential environmental impacts associated with mercury in dental amalgam discharged to surface water by POTWs (DCN DA00148). As discussed above, studies indicate that dental offices are the largest source of mercury entering POTWs. The total annual baseline discharge of dental mercury to POTWs is approximately 10,239 pounds (5.1 tons): 10,198 pounds are in the form of solid particles (99.6 percent) and 41 pounds (0.4 percent) are dissolved in the wastewater (DCN DA00018). Through POTW treatment, approximately 90 percent of dental mercury is removed from the wastewater and transferred to sewage sludge. The 10 percent of dental mercury not removed by POTW treatment is discharged to surface water. EPA estimates that POTWs annually discharge approximately 1,003 pounds of dental mercury nationwide. The CWA regulations known as Standards for Use and Disposal of Sewage Sludge, 40 CFR part 503, control the land application, surface disposal, and incineration of sewage sludge generated by POTWs. Of the 11.2 billion dry pounds of sewage sludge generated annually, about 60 percent, or 6.7 billion pounds, are treated to produce biosolids for beneficial use as a soil amendment and applied to about 0.1 percent of agricultural lands in the United States (DCN DA00257). Approximately 5,500 pounds per year of dental mercury are contained in landapplied biosolids. Approximately 18 percent, or 2 billion pounds, of the sewage sludge generated annually by POTWs are surface disposed in sewage sludge mono-fills or municipal landfills. Approximately 1,700 pounds per year of dental mercury are contained in surface disposed sewage sludge. Pollutant limits and monitoring requirements for surface disposed sewage sludge mono-fills are set by 40 CFR part 503 and by 40 CFR part 258 for municipal landfills. There may be additional state or local regulations that are more stringent than the federal biosolids regulations. The remaining 22 percent, or 2.5 billion pounds, of sewage sludge generated annually by POTWs is disposed of through incineration. Approximately 2,000 pounds per year of dental mercury are contained in incinerated sewage sludge. 40 CFR part 503, subpart E sets requirements for the incineration of mercury and other toxic metals in sludge. For mercury, subpart E provides that incineration of sludge must meet the requirements of the National Emissions Standards for Mercury in subpart E of 40 CFR part 61. Environmental assessment of impacts associated with POTW discharges of dental mercury is complicated by uncertainties about the fate and transport of mercury in aquatic environments. The elemental form of mercury used in dentistry has low water solubility and is not readily absorbed when ingested by humans, fish, or wildlife. However, elemental mercury may be converted into highly toxic methylmercury in aquatic environments by certain forms of anaerobic sulfatereducing bacteria. Methylmercury has high potential to become increasingly concentrated up through aquatic food chains as larger fish eat smaller fish. 24 When EPA first developed TWFs in 1981, it chose the copper freshwater chronic aquatic life criterion of 5.6 mg/L as the benchmark scaling factor for deriving TWFs because copper was a common and well-studied toxic chemical in industrial waste streams. Consequently, the basic equation for deriving the TWF for any chemical is: TWF = 5.6 mg/L/Aquatic Life Value (mg/L) + 5.6 mg/L/Human Health Value (mg/L). The chronic freshwater aquatic life criterion for copper, however, has been revised three times since it was first published in 1980 due to advances in the scientific understanding of its toxic effects. Thus, when calculating the TWF for copper, EPA normalizes the 1998 chronic freshwater aquatic life copper criterion of 9.0 mg/L to the original 1980 copper criterion of 5.6 mg/L by dividing 5.6 mg/L by 9.0 mg/L and adding the quotient to 5.6 mg/L divided by the copper human health value of 4444 mg/L, which results in a copper TWF of 0.623. XI. Environmental Assessment mstockstill on DSK30JT082PROD with RULES $23.5 24.1 Removals (lbs-eq) VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 PO 00000 Frm 00069 Fmt 4700 Sfmt 4700 E:\FR\FM\14JNR1.SGM 14JNR1 27174 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations mstockstill on DSK30JT082PROD with RULES Fish commonly eaten by humans may have methylmercury levels 100,000 times that of ambient water. The neurological effects of consumption of methylmercury-contaminated fish are well documented. Developmental effects to fetuses, infants, children, and fish consumption by women of childbearing age are of special concern. Neurological effects from predation of methylmercury-contaminated fish have been documented to occur in wild populations of fish, birds, and mammals in many areas of the United States (DCN DA00202). A plausible link has been identified between anthropogenic sources of mercury in the United States and methylmercury in fish. However, fish methylmercury concentrations also result from existing background concentrations of mercury which may consist of mercury from natural sources and atmospheric deposition of mercury in the United States from sources in other countries. Given the current scientific understanding of the environmental fate and transport of mercury, it is not possible to quantify how much of the methylmercury in fish consumed by the U.S. population is contributed by U.S. emissions relative to international mercury sources or natural mercury sources. EPA was unable to assess the specific environmental impacts of dental mercury discharged by POTWs due to insufficient data needed to evaluate several fundamental factors about the discharge, fate, and transport of dental mercury in aquatic environments, including: the degree and geographic extent of dental mercury methylation in aquatic environments, the amount of methylated dental mercury that is taken up by fish and wildlife, the human consumption rates of fish contaminated with methylated dental mercury, and the extent and magnitude of naturallyoccurring mercury in aquatic environments. B. Environmental Benefits While EPA did not perform a quantitative environmental benefits analysis of the final rule, due to insufficient data about the aquatic fate and transport of dental mercury discharged by POTWs, EPA was able to assess the qualitative environmental benefits based on existing information. For example, EPA identified studies that show that decreased point-source discharges of mercury to surface water result in lower methylmercury concentrations in fish. Moreover, several studies quantify economic benefits from improved human health and ecological conditions resulting from lower fish concentrations of VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 methylmercury (DCN DA00148). The final pretreatment standards will produce human health and ecological benefits by reducing the estimated annual nationwide POTW discharge of dental mercury to surface water from 1,003 pounds to 11 pounds. XII. Non-Water Quality Environmental Impacts Associated With the Technology Basis of the Rule Eliminating or reducing one form of pollution may cause other environmental problems. Sections 304(b) and 306 of the Clean Water Act require EPA to consider non-water quality environmental impacts (including energy requirements) associated with effluent limitations guidelines and standards. To comply with these requirements, EPA considered the potential impact of the technology basis on energy consumption, air pollution, and solid waste generation. As shown below, EPA anticipates that the rule would produce minimal non-water quality environmental impacts and as such determined they are acceptable. Additional information about the analysis of these non-water quality impacts is contained in the TEDD. A. Energy Requirements Net energy consumption considers the incremental electrical requirements associated with operating and maintaining dental amalgam separators used in combination with BMPs that form the technology basis for the standards. As described in Section V, most amalgam separators use sedimentation, either alone or in conjunction with filtration to remove solids in the waste stream. Most separators rely on gravity or the suction of the existing vacuum system to operate, and do not require an additional electrical power source. As noted in Section V, some separators have warning indicators that require a battery or power source. EPA does not anticipate this would pose any considerable energy requirements. Moreover, the addition of an amalgam separator is likely to reduce energy consumption at dental offices that do not currently employ an amalgam separator as it will prevent small particles from impeding the vacuum pump impeller. A clean impeller is more efficient than a dirty impeller, and thus will draw less energy (DCN DA00465). Upon consideration of all of these factors, EPA concludes there will be no significant energy requirements associated with this final rule. PO 00000 Frm 00070 Fmt 4700 Sfmt 4700 B. Air Emissions Unbound mercury is highly volatile and can easily evaporate into the atmosphere. An estimated 99.6 percent of dental mercury discharges are in solid bound form; i.e. elemental mercury bound to amalgam particles (DCN DA00018). Because the majority of dental mercury is bound to solid particles, it likely will not volatize to the atmosphere. Therefore, EPA expects the final PSES and PSNS will not pose any increases in air pollution. C. Solid Waste Generation In the absence of amalgam separators, a portion of the amalgam rinsed into chair-side drains is collected by chairside traps. The remainder is discharged to the POTW where the vast majority is removed from the wastewater and becomes part of the POTW sludge that may be land-applied, disposed of in landfills or mono-fills, or incinerated. EPA expect the final rule to increase the use of amalgam separators nationwide by one and a half times with a corresponding increase in collection and recycling of used amalgam from the spent separator canisters. EPA expects the operation and maintenance requirements associated with the amalgam separator compliance option included in the final rule will further promote recycling as the primary means of amalgam waste management, because many amalgam separator manufactures and dental office suppliers have begun offering waste handling services that send dental amalgam waste to retorting and recycling facilities. Nationally, EPA expects less dental amalgam will be discharged to POTWs leading to reductions in the amount of mercury discharged to surface waters and landapplied, landfilled, or released to the air during incineration of sludge. Instead, EPA expects that the waste will be collected in separator canisters and recycled. After the amalgam containing waste has been recycled, the canisters are either recycled or landfilled. For purposes of assessing the incremental solid waste generation, EPA conservatively assumes all of the canisters are landfilled. EPA finds that if each dental office generated an average of 2 pounds of spent canisters per year, the total mass of solid waste generated would still comprise less than 0.0001 percent of the 254 million tons of solid waste generated by Americans annually (DCN DA00496). Based on this evaluation of incremental solid waste generation, EPA concludes there will not be a significant incremental nonwater quality impact associated with E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations solid waste generation as a result of this final rule. XIII. Standards for Reference This rule references standards from the American National Standards Institute/American Dental Association and the International Organization for Standardization, and in compliance with the National Technology Transfer and Advancement Act (see Section XIV). They are available either at EPA’s Water Docket (see ADDRESSES section above) for inspection, or on their respective Web sites to everyone at a cost determined by the respective Web site, generally from $100 to $150. The cost of obtaining these standards is not a significant financial burden for a discharger or environmental laboratory, making the standards reasonably available. The individual standards are discussed in greater detail below. The installation, operation, and maintenance of one or more amalgam separators compliant with either the ADA 2009 standard with the 2011 addendum, or the ISO standard when removing dental amalgam solids from all amalgam process wastewater: • ANSI/ADA Specification No. 108:2009, American National Standard/ American Dental Association Specification No. 108 Amalgam Separators. • ANSI/ADA Specification No. 108:2009 Addendum, American National Standard/American Dental Association Specification No. 108 Amalgam Separators, Addendum. • International Standard ISO 11143;2008, Dentistry—Amalgam Separators. XIV. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. mstockstill on DSK30JT082PROD with RULES A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review because it raises novel legal or policy issues. Any changes made in response to OMB recommendations have been documented in the docket. The economic analysis is available in the docket (DCN DA00458) and is briefly summarized in Section IX. The benefits are summarized in Section XI. VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 B. Paperwork Reduction Act The information collection requirements in this final rule have been submitted for approval to the OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document prepared by EPA has been assigned EPA ICR number 2514.02. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them. EPA estimates it would take a total annual average of 402,000 hours and $7.2 million for affected dental offices to collect and report the information required in the final rule. This estimate includes effort for each dental office associated with completing a one-time compliance report. EPA based this estimate on average labor rates from the Bureau of Labor Statistics for the dental office personnel involved in collecting and reporting the information required. EPA estimates it would take a total annual average of 34,000 hours and $2.02 million for Control Authorities to review the information submitted by dental offices. EPA estimates that there would be no start-up or capital costs associated with the information described above. Burden is defined at 5 CFR 1320(b). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce the approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities in this final rule. C. Regulatory Flexibility Act I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are defined as: (1) A small business in the Dental Office sector (NAICS 621210) with annual receipts of 7.5 million dollars or less (based on SBA size standards); (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-forprofit enterprise which is independently owned and operated and is not dominant in its field. PO 00000 Frm 00071 Fmt 4700 Sfmt 4700 27175 The Agency has determined that 116,014 dental offices out of 116,720 dental offices potentially subject to this final rule meet the small business definition. EPA’s analysis of projected impacts on small dental offices is described in detail in Section IX. EPA projects less than 1 percent of 116,720 affected dental offices would incur compliance costs exceeding 1 percent of revenue and no more than 0.2 percent would incur compliance costs exceeding 3 percent of revenue. Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this final rule on small entities. First, this final rule will allow dental offices with existing separators to satisfy the requirements for a period of up to 10 years. Second, EPA significantly reduced the rule’s reporting requirements for all affected dental offices as compared to the reporting requirements for other industries with categorical pretreatment standards. D. Unfunded Mandates Reform Act (UMRA) This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531–1538, and does not significantly or uniquely affect small governments. The annual cost of the final rule is $59 to $61 million; thus, this final rule is not subject to the requirements of sections 202 or 205 of UMRA. This final rule is also not subject to the requirements of section 203 of UMRA, because it contains no regulatory requirements that may significantly or uniquely affect small governments. EPA has not identified any dental offices that are owned by small governments. While this final rule impacts government entities required to administer pretreatment standards, small governments will generally not be affected. By statute, a small government jurisdiction is defined as a government of a city, county, town, school district or special district with a population of less than 50,000 (5 U.S.C 601). Control authorities are responsible for oversight and administration associated with this final rule. A POTW is required to become a Control Authority when it (or a combination of POTWs operated by the same authority) has a design flow of at least 5 million gallons per day and receives pollutants from industrial users that would pass through or interfere with the operations and cause a violation of the POTW’s NPDES permit. The average water use per person is 100 gallons per day so a POTW with a E:\FR\FM\14JNR1.SGM 14JNR1 27176 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations population less than 50,000 would likely have a flow less than 5 MGD. Therefore, EPA does not expect small government owned POTWs to be required to become a Control Authority. EPA is aware that some small POTWs have approved pretreatment programs so they serve as a Control Authority. To the extent small POTWs with preexisting approved pretreatment programs receive dental discharges subject to this rule, they would incur some incremental oversight requirements as described in Section VI. However, EPA expects such cases to be limited. E. Executive Order 13132: Federalism This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. mstockstill on DSK30JT082PROD with RULES F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This final rule does not have tribal implications, as specified in Executive Order 13175. It does not have substantial direct effects on Tribal governments, on the relationship between the Federal government and Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes. This final rule contains no Federal mandates for Tribal governments and does not impose any enforceable duties on Tribal governments. Thus, Executive Order 13175 does not apply to this final rule. G. Executive Order 13045: Protection of Children From Environmental Health and Safety Risks This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because EPA does not project the environmental health or safety risks addressed by this action present a disproportionate risk to children. This final rule will reduce the amount of mercury from dental amalgam entering POTW’s and eventually the nation’s waters, which will reduce impacts to the neurological development of children. H. Executive Order 13211: Energy Effects This action is not a ‘‘significant energy action’’ because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 EPA determined that any additional energy usage would be insignificant to the total energy usage of Dental Offices and total annual U.S. energy consumption. I. National Technology Transfer and Advancement Act This final rule involves technical standards. The Agency decided to use the American National Standards Institute (ANSI) American National Standard/American Dental Association (ADA) Specification 108 for Amalgam Separators (2009) with Technical Addendum (2011) or the International Organization for Standardization (ISO) 11143 Standard (2008) or the International Organization for Standardization (ISO) efficiency standards for amalgam separators (ISO 11143) developed in 1999 and updated in 2008. One approach to meet the standards in this rule is to install and operate an amalgam separator(s) compliant with one of these standards or their equivalent. These voluntary standard setting organizations established a standard for measuring amalgam separator efficiency by evaluating the retention of amalgam mercury using specified test procedures in a laboratory setting. They also include requirements for instructions for use and operation and maintenance. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations EPA determined that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, lowincome populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). While EPA was unable to perform a detailed environmental justice analysis because it lacks data on the location of POTWs to which dental discharges currently occur, this final rule will increase the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. This final rule will reduce the amount of mercury from dental amalgam entering POTW’s and eventually the nation’s waters, to benefit all of society, including minority communities. K. Congressional Review Act (CRA) This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the PO 00000 Frm 00072 Fmt 4700 Sfmt 4700 Comptroller General of the United States. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 441 Environmental protection, Dental, Dental office, Dentist, Mercury, Pretreatment, Waste treatment and disposal, Water pollution control. Dated: June 9, 2017. Michael H. Shapiro, Acting Assistant Administrator. Therefore, 40 CFR part 441 is amended by adding part 441 to read as follows: PART 441—DENTAL OFFICE POINT SOURCE CATEGORY Sec. 441.10 Applicability. 441.20 General definitions. 441.30 Pretreatment standards for existing sources (PSES). 441.40 Pretreatment standards for new sources (PSNS). 441.50 Reporting and recordkeeping requirements. Authority: 33 U.S.C. 1251, 1311, 1314, 1316, 1317, 1318, 1342, and 1361. 42 U.S.C. 13101–13103. § 441.10 Applicability. (a) Except as provided in paragraphs (c), (d), and (e) of this section, this part applies to dental dischargers. (b) Unless otherwise designated by the Control Authority, dental dischargers subject to this part are not Significant Industrial Users as defined in 40 CFR part 403, and are not ‘‘Categorical Industrial Users’’ or ‘‘industrial users subject to categorical pretreatment standards’’ as those terms and variations are used in 40 CFR part 403, as a result of applicability of this rule. (c) This part does not apply to dental dischargers that exclusively practice one or more of the following dental specialties: Oral pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, periodontics, or prosthodontics. (d) This part does not apply to wastewater discharges from a mobile unit operated by a dental discharger. (e) This part does not apply to dental dischargers that do not discharge any amalgam process wastewater to a POTW, such as dental dischargers that collect all dental amalgam process wastewater for transfer to a Centralized Waste Treatment facility as defined in 40 CFR part 437. (f) Dental Dischargers that do not place dental amalgam, and do not remove amalgam except in limited emergency or unplanned, unanticipated circumstances, and that certify such to E:\FR\FM\14JNR1.SGM 14JNR1 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations the Control Authority as required in § 441.50 are exempt from any further requirements of this part. § 441.20 General definitions. For purposes of this part: (a) Amalgam process wastewater means any wastewater generated and discharged by a dental discharger through the practice of dentistry that may contain dental amalgam. (b) Amalgam separator means a collection device designed to capture and remove dental amalgam from the amalgam process wastewater of a dental facility. (c) Control Authority is defined in 40 CFR 403.3(f). (d) Dental amalgam means an alloy of elemental mercury and other metal(s) that is used in the practice of dentistry. (e) Dental Discharger means a facility where the practice of dentistry is performed, including, but not limited to, institutions, permanent or temporary offices, clinics, home offices, and facilities owned and operated by Federal, state or local governments, that discharges wastewater to a publicly owned treatment works (POTW). (f) Duly Authorized Representative is defined in 40 CFR 403.12(l)(3). (g) Existing Sources means a dental discharger that is not a new source. (h) Mobile unit means a specialized mobile self-contained van, trailer, or equipment used in providing dentistry services at multiple locations. (i) New Sources means a dental discharger whose first discharge to a POTW occurs after July 14, 2017. (j) Publicly Owned Treatment Works is defined in 40 CFR 403.3(q). mstockstill on DSK30JT082PROD with RULES § 441.30 Pretreatment standards for existing sources (PSES). No later than July 14, 2020, any existing source subject to this part must achieve the following pretreatment standards: (a) Removal of dental amalgam solids from all amalgam process wastewater by one of the following methods: (1) Installation, operation, and maintenance of one or more amalgam separators that meet the following requirements: (i) Compliant with either the American National Standards Institute (ANSI) American National Standard/ American Dental Association (ADA) Specification 108 for Amalgam Separators (2009) with Technical Addendum (2011) or the International Organization for Standardization (ISO) 11143 Standard (2008) or subsequent versions so long as that version requires amalgam separators to achieve at least a 95% removal efficiency. Compliance VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 must be assessed by an accredited testing laboratory under ANSI’s accreditation program for product certification or a testing laboratory that is a signatory to the International Laboratory Accreditation Cooperation’s Mutual Recognition Arrangement. The testing laboratory’s scope of accreditation must include ANSI/ADA 108–2009 or ISO 11143. (ii) The amalgam separator(s) must be sized to accommodate the maximum discharge rate of amalgam process wastewater. (iii) A dental discharger subject to this part that operates an amalgam separator that was installed at a dental facility prior to June 14, 2017, satisfies the requirements of paragraphs (a)(1)(i) and (ii) of this section until the existing separator is replaced as described in paragraph (a)(1)(v) of this section or until June 14, 2017, whichever is sooner. (iv) The amalgam separator(s) must be inspected in accordance with the manufacturer’s operating manual to ensure proper operation and maintenance of the separator(s) and to confirm that all amalgam process wastewater is flowing through the amalgam retaining portion of the amalgam separator(s). (v) In the event that an amalgam separator is not functioning properly, the amalgam separator must be repaired consistent with manufacturer instructions or replaced with a unit that meets the requirements of paragraphs (a)(i) and (ii) of this section as soon as possible, but no later than 10 business days after the malfunction is discovered by the dental discharger, or an agent or representative of the dental discharger. (vi) The amalgam retaining units must be replaced in accordance with the manufacturer’s schedule as specified in the manufacturer’s operating manual or when the amalgam retaining unit has reached the maximum level, as specified by the manufacturer in the operating manual, at which the amalgam separator can perform to the specified efficiency, whichever comes first. (2) Installation, operation, and maintenance of one or more amalgam removal device(s) other than an amalgam separator. The amalgam removal device must meet the following requirements: (i) Removal efficiency of at least 95 percent of the mass of solids from all amalgam process wastewater. The removal efficiency must be calculated in grams recorded to three decimal places, on a dry weight basis. The removal efficiency must be demonstrated at the maximum water flow rate through the PO 00000 Frm 00073 Fmt 4700 Sfmt 4700 27177 device as established by the device manufacturer’s instructions for use. (ii) The removal efficiency must be determined using the average performance of three samples. The removal efficiency must be demonstrated using a test sample of dental amalgam that meets the following particle size distribution specifications: 60 percent by mass of particles that pass through a 3150 mm sieve but which do not pass through a 500 mm sieve, 10 percent by mass of particles that pass through a 500 mm sieve but which do not pass through a 100 mm sieve, and 30 percent by mass of particles that pass through a 100 mm sieve. Each of these three specified particle size distributions must contain a representative distribution of particle sizes. (iii) The device(s) must be sized to accommodate the maximum discharge rate of amalgam process wastewater. (iv) The devices(s) must be accompanied by the manufacturer’s manual providing instructions for use including the frequency for inspection and collecting container replacement such that the unit is replaced once it has reached the maximum filling level at which the device can perform to the specified efficiency. (v) The device(s) must be inspected in accordance with the manufacturer’s operation manual to ensure proper operation and maintenance, including confirmation that amalgam process wastewater is flowing through the amalgam separating portion of the device(s). (vi) In the event that a device is not functioning properly, it must be repaired consistent with manufacturer instructions or replaced with a unit that meets the requirements of paragraphs (a)(2)(i) through (iii) of this section as soon as possible, but no later than 10 business days after the malfunction is discovered by the dental discharger, or an agent or representative of the dental discharger. (vii) The amalgam retaining unit(s) of the device(s) must be replaced as specified in the manufacturer’s operating manual, or when the collecting container has reached the maximum filling level, as specified by the manufacturer in the operating manual, at which the amalgam separator can perform to the specified efficiency, whichever comes first. (viii) The demonstration of the device(s) under paragraphs (a)(2)(i) through (iii) of this section must be documented in the One-Time Compliance Report. (b) Implementation of the following best management practices (BMPs): E:\FR\FM\14JNR1.SGM 14JNR1 27178 Federal Register / Vol. 82, No. 113 / Wednesday, June 14, 2017 / Rules and Regulations (1) Waste amalgam including, but not limited to, dental amalgam from chairside traps, screens, vacuum pump filters, dental tools, cuspidors, or collection devices, must not be discharged to a POTW. (2) Dental unit water lines, chair-side traps, and vacuum lines that discharge amalgam process wastewater to a POTW must not be cleaned with oxidizing or acidic cleaners, including but not limited to bleach, chlorine, iodine and peroxide that have a pH lower than 6 or greater than 8. (c) All material is available for inspection at EPA’s Water Docket, EPA West, 1301 Constitution Avenue NW., Room 3334, Washington, DC 20004, Telephone: 202–566–2426, and is available from the sources listed below. (1) The following standards are available from the American Dental Association (ADA), 211 East Chicago Ave., Chicago IL 60611–2678, Telephone 312–440–2500, http:// www.ada.org. (i) ANSI/ADA Specification No. 108:2009, American National Standard/ American Dental Association Specification No. 108 Amalgam Separators. February 2009. (ii) ANSI/ADA Specification No. 108:2009 Addendum, American National Standard/American Dental Association Specification No. 108 Amalgam Separators, Addendum. November 2011. (2) The following standards are available from the American National Standards Institute (ANSI), 25 West 43rd Street, 4th Floor, New York, NY 10036, Telephone 212–642–4900, http:// webstore.ansi.org. (i) International Standard ISO 11143:2008, Dentistry—Amalgam Separators. Second edition, July 1, 2008. (ii) [Reserved] § 441.40 Pretreatment standards for new sources (PSNS). As of July 14, 2017, any new source subject to this part must comply with the requirements of § 441.30(a) and (b) and the reporting and recordkeeping requirements of § 441.50. mstockstill on DSK30JT082PROD with RULES § 441.50 Reporting and recordkeeping requirements. (a) Dental Dischargers subject to this part must comply with the following reporting requirements in lieu of the otherwise applicable requirements in 40 CFR 403.12(b), (d), (e), and (g). (1) One-Time Compliance Report deadlines. For existing sources, a OneTime Compliance Report must be submitted to the Control Authority no later than October 12, 2020, or 90 days after a transfer of ownership. For new VerDate Sep<11>2014 16:55 Jun 13, 2017 Jkt 241001 sources, a One-Time Compliance Report must be submitted to the Control Authority no later than 90 days following the introduction of wastewater into a POTW. (2) Signature and certification. The One-Time Compliance Report must be signed and certified by a responsible corporate officer, a general partner or proprietor if the dental discharger is a partnership or sole proprietorship, or a duly authorized representative in accordance with the requirements of 40 CFR 403.12(l). (3) Contents. (i) The One-Time Compliance Report for dental dischargers subject to this part that do not place or remove dental amalgam as described at § 441.10(f) must include the: facility name, physical address, mailing address, contact information, name of the operator(s) and owner(s); and a certification statement that the dental discharger does not place dental amalgam and does not remove amalgam except in limited circumstances. (ii) The One-Time Compliance Report for dental dischargers subject to the standards of this part must include: (A) The facility name, physical address, mailing address, and contact information. (B) Name(s) of the operator(s) and owner(s). (C) A description of the operation at the dental facility including: The total number of chairs, the total number of chairs at which dental amalgam may be present in the resulting wastewater, and a description of any existing amalgam separator(s) or equivalent device(s) currently operated to include, at a minimum, the make, model, year of installation. (D) Certification that the amalgam separator(s) or equivalent device is designed and will be operated and maintained to meet the requirements specified in § 441.30 or § 441.40. (E) Certification that the dental discharger is implementing BMPs specified in § 441.30(b) or § 441.40(b) and will continue to do so. (F) The name of the third-party service provider that maintains the amalgam separator(s) or equivalent device(s) operated at the dental office, if applicable. Otherwise, a brief description of the practices employed by the facility to ensure proper operation and maintenance in accordance with § 441.30 or § 441.40. (4) Transfer of ownership notification. If a dental discharger transfers ownership of the facility, the new owner must submit a new One-Time Compliance Report to the Control Authority no later than 90 days after the transfer. PO 00000 Frm 00074 Fmt 4700 Sfmt 4700 (5) Retention period. As long as a Dental Discharger subject to this part is in operation, or until ownership is transferred, the Dental Discharger or an agent or representative of the dental discharger must maintain the One-Time Compliance Report required at paragraph (a) of this section and make it available for inspection in either physical or electronic form. (b) Dental Dischargers or an agent or representative of the dental discharger must maintain and make available for inspection in either physical or electronic form, for a minimum of three years: (1) Documentation of the date, person(s) conducting the inspection, and results of each inspection of the amalgam separator(s) or equivalent device(s), and a summary of follow-up actions, if needed. (2) Documentation of amalgam retaining container or equivalent container replacement (including the date, as applicable). (3) Documentation of all dates that collected dental amalgam is picked up or shipped for proper disposal in accordance with 40 CFR 261.5(g)(3), and the name of the permitted or licensed treatment, storage or disposal facility receiving the amalgam retaining containers. (4) Documentation of any repair or replacement of an amalgam separator or equivalent device, including the date, person(s) making the repair or replacement, and a description of the repair or replacement (including make and model). (5) Dischargers or an agent or representative of the dental discharger must maintain and make available for inspection in either physical or electronic form the manufacturers operating manual for the current device. [FR Doc. 2017–12338 Filed 6–12–17; 11:15 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 2, 15, 80, 90, 97, and 101 [ET Docket No. 15–99; FCC 17–33] WRC–12 Implementation Report and Order Federal Communications Commission. ACTION: Final rule. AGENCY: In this document, the Commission implemented allocation changes from the World Radiocommunication Conference SUMMARY: E:\FR\FM\14JNR1.SGM 14JNR1