Revision of Certain Federal Water Quality Criteria Applicable to Washington, 85417-85437 [2016-28424]

Download as PDF Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations Order 13132 (64 FR 43255, August 10, 1999); • Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); • Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); • Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and • Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994). In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law. The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 27, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2). 85417 List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: November 7, 2016. Heather McTeer Toney, Regional Administrator, Region 4. 40 CFR part 52 is amended as follows: PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: ■ Authority: 42 U.S.C. 7401 et seq. Subpart RR—Tennessee 2. In § 52.2220, the table in paragraph (e) is amended by adding the entry ‘‘110(a)(1) and (2) Infrastructure Requirements for the 2010 1-hour SO2 NAAQS’’ at the end of the table to read as follows: ■ § 52.2220 * Identification of plan. * * (e) * * * * * EPA-APPROVED TENNESSEE NON-REGULATORY PROVISIONS Applicable geographic or nonattainment area State effective date EPA approval date Explanation * Tennessee ............. * 03/13/2014 * 11/28/16, [insert Federal Register citation]. * * With the exception of interstate transport requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4). Name of non-regulatory SIP provision * * 110 (a)(1) and (2) Infrastructure Requirements for the 2010 1-hour SO2 NAAQS. BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 131 [EPA–HQ–OW–2015–0174; FRL–9955–40– OW] mstockstill on DSK3G9T082PROD with RULES RIN 2040–AF56 Revision of Certain Federal Water Quality Criteria Applicable to Washington Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 On September 14, 2015, the Environmental Protection Agency (EPA) proposed revisions to the federal Clean Water Act (CWA) human health criteria applicable to waters under the State of Washington’s jurisdiction to ensure that the criteria are set at levels that will adequately protect Washington residents, including tribes with treatyreserved rights, from exposure to toxic pollutants. EPA promulgated Washington’s previous criteria for the protection of human health in 1992 as part of the National Toxics Rule (NTR) (amended in 1999 for Polychlorinated Biphenyls (PCBs)), using the Agency’s recommended criteria values at the time. EPA derived those previously applicable criteria using a fish consumption rate (FCR) of 6.5 grams per SUMMARY: [FR Doc. 2016–28429 Filed 11–25–16; 8:45 am] PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 day (g/day) based on national surveys. The best available data now demonstrate that fish consumers in Washington consume much more fish than 6.5 g/day. There are also new data and scientific information available to update the toxicity and exposure parameters used to calculate human health criteria. On August 1, 2016, the State of Washington adopted and submitted human health criteria for certain pollutants, reflecting some of these new data and information. Concurrent with this final rule, EPA is taking action under CWA 303(c) to approve in part, and disapprove in part, the human health criteria submitted by Washington. For those criteria that EPA disapproved, EPA is finalizing federal human health criteria in this final rule. E:\FR\FM\28NOR1.SGM 28NOR1 85418 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations EPA is not finalizing criteria in this final rule for those state-adopted criteria that EPA approved, or for certain criteria that EPA has determined involve scientific uncertainty, as explained below. DATES: This final rule is effective on December 28, 2016. ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA–HQ–OW–2015–0174. 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. Publicly available docket materials are available electronically through https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Erica Fleisig, Office of Water, Standards and Health Protection Division (4305T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 566–1057; email address: fleisig.erica@ epa.gov. SUPPLEMENTARY INFORMATION: This final rule is organized as follows: I. General Information A. Does this action apply to me? B. How did EPA develop this final rule? II. Background A. Statutory and Regulatory Background B. EPA’s CWA 303(c) Action on Washington’s Human Health Criteria C. General Recommended Approach for Deriving Human Health Criteria III. Derivation of Human Health Criteria for Washington A. Scope of Pollutants and Waters Covered by This Final Rule B. Washington’s Designated Uses and Tribal Reserved Fishing Rights C. Washington-Specific Human Health Criteria Inputs D. Final Human Health Criteria for Washington E. Applicability of Criteria F. Alternative Regulatory Approaches and Implementation Mechanisms IV. Economic Analysis A. Identifying Affected Entities B. Method for Estimating Costs C. Results V. 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 and Safety Risks) H. Executive Order 13211 (Actions That Significantly Affect Energy Supply, Distribution, or Use) I. National Technology Transfer and Advancement Act of 1995 J. Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations) K. Congressional Review Act (CRA) I. General Information A. Does this action apply to me? Entities such as industries, stormwater management districts, or publicly owned treatment works (POTWs) that discharge pollutants to waters of the United States under the State of Washington’s jurisdiction could be indirectly affected by this rulemaking, because federal water quality standards (WQS) promulgated by EPA are applicable to CWA regulatory programs, such as National Pollutant Discharge Elimination System (NPDES) permitting. Citizens concerned with water quality in Washington could also be interested in this rulemaking. Categories and entities that could potentially be affected include the following: Category Examples of potentially affected entities Industry ........................................... Municipalities ................................... Industries discharging pollutants to waters of the United States in Washington. Publicly owned treatment works or other facilities discharging pollutants to waters of the United States in Washington. Entities responsible for managing stormwater runoff in the State of Washington. Stormwater Management Districts .. mstockstill on DSK3G9T082PROD with RULES This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities that could be indirectly affected by this action. Any parties or entities who depend upon or contribute to the water quality of Washington’s waters could be indirectly affected by this rule. To determine whether your facility or activities could be indirectly affected by this action, you should carefully examine this rule. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section. B. How did EPA develop this final rule? In developing this final rule, EPA carefully considered the public comments and feedback received from interested parties. EPA originally provided a 60-day public comment period after publishing the proposed rule in the Federal Register on VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 September 14, 2015.1 On October 28, 2015, in response to stakeholder requests,2 EPA extended the public comment period for an additional 45 days.3 In addition, EPA held two virtual public hearings on December 15th and 16th, 2015, to discuss the contents of the proposed rule and accept verbal public comments. Over 60 organizations and individuals submitted comments on a range of 1 See Revision of Certain Federal Water Quality Criteria Applicable to Washington: Proposed Rule, 80 FR 55063, September 14, 2015. 2 EPA received requests from the Association of Washington Business—Washington State’s Chamber of Commerce, Washington Public Ports Association (on behalf of the Association of Washington Cities and the Washington State Association of Counties), Western Wood Preservers Institute, ALCOA, American Forest and Paper Association, McFarland Cascade, Schnitzer Steel Industries, and Weyerhaeuser. 3 See Extension of Public Comment Period for the Revision of Certain Federal Water Quality Criteria Applicable to Washington, 80 FR 65980, October 28, 2015. PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 issues. EPA also received over 400 letters from individuals associated with mass letter writing campaigns. Some comments addressed issues beyond the scope of the rulemaking, and thus EPA did not consider them in finalizing this rule. In each section of this preamble, EPA discusses certain public comments so that the public is aware of the Agency’s position. For a full response to these and all other comments, see EPA’s Response to Comments document in the official public docket. II. Background A. Statutory and Regulatory Background CWA section 101(a)(2) establishes as a national goal ‘‘water quality which provides for the protection and propagation of fish, shellfish, and wildlife, and recreation in and on the water, wherever attainable.’’ These are commonly referred to as the ‘‘fishable/ swimmable’’ goals of the CWA. EPA E:\FR\FM\28NOR1.SGM 28NOR1 mstockstill on DSK3G9T082PROD with RULES Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations interprets ‘‘fishable’’ uses to include, at a minimum, designated uses providing for the protection of aquatic communities and human health related to consumption of fish and shellfish.4 CWA section 303(c) (33 U.S.C. 1313(c)) directs states to adopt WQS for their waters subject to the CWA. CWA section 303(c)(2)(A) and EPA’s implementing regulations at 40 CFR part 131 require, among other things, that a state’s WQS specify appropriate designated uses of the waters, and water quality criteria that protect those uses. EPA’s regulations at 40 CFR 131.11(a)(1) provide that ‘‘[s]uch criteria must be based on sound scientific rationale and must contain sufficient parameters or constituents to protect the designated use. For waters with multiple use designations, the criteria shall support the most sensitive use.’’ In addition, 40 CFR 131.10(b) provides that ‘‘[i]n designating uses of a water body and the appropriate criteria for those uses, the state shall take into consideration the water quality standards of downstream waters and ensure that its water quality standards provide for the attainment and maintenance of the water quality standards of downstream waters.’’ States are required to review applicable WQS at least once every three years and, if appropriate, revise or adopt new standards (CWA section 303(c)(1)). Any new or revised WQS must be submitted to EPA for review and approval or disapproval (CWA section 303(c)(2)(A) and (c)(3)). If EPA disapproves a state’s new or revised WQS, the CWA provides the state 90 days to adopt a revised WQS that meets CWA requirements, and if it fails to do so, EPA shall promptly propose and then within 90 days promulgate such standard unless EPA approves a state replacement WQS first (CWA section 303(c)(3) and (c)(4)(A)). CWA section 303(c)(4)(B) authorizes the Administrator to determine that a new or revised standard is needed to meet CWA requirements. Upon making such a determination, the CWA specifies that EPA shall promptly propose, and then within 90 days promulgate, any such new or revised standard unless prior to such promulgation, the state has adopted a revised or new WQS that EPA determines to be in accordance with the CWA. Under CWA section 304(a), EPA periodically publishes criteria recommendations for states to consider when adopting water quality criteria for 4 USEPA. 2000. Memorandum #WQSP–00–03. U.S. Environmental Protection Agency, Office of Water, Washington, DC https://www.epa.gov/sites/ production/files/2015-01/documents/standardsshellfish.pdf. VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 particular pollutants to protect the CWA section 101(a)(2) goal uses. In 2015, EPA updated its 304(a) recommended criteria for human health for 94 pollutants.5 Where EPA has published recommended criteria, states should establish numeric water quality criteria based on EPA’s CWA section 304(a) criteria, section 304(a) criteria modified to reflect site-specific conditions, or other scientifically defensible methods (40 CFR 131.11(b)(1)). In all cases criteria must be sufficient to protect the designated use and be based on sound scientific rationale (40 CFR 131.11(a)(1)). CWA section 303(c)(2)(B) requires states to adopt numeric criteria for all toxic pollutants listed pursuant to CWA section 307(a)(1) for which EPA has published 304(a) criteria, as necessary to support the states’ designated uses. In 1992, EPA promulgated the NTR at 40 CFR 131.36, establishing chemicalspecific numeric criteria for 85 priority toxic pollutants for 14 states and territories (states), including Washington, that were not in compliance with the requirements of CWA section 303(c)(2)(B). When states covered by the NTR subsequently adopted their own criteria for toxic pollutants that EPA approved as consistent with the CWA and EPA’s implementing regulations, EPA amended the NTR to remove those criteria for those states. B. EPA’s CWA 303(c) Action on Washington’s Human Health Criteria On September 14, 2015, EPA made a CWA 303(c)(4)(B) determination that new or revised WQS for the protection of human health in Washington were necessary to meet the requirements of the CWA, and proposed revised human health criteria for the state (see 80 FR 55063). At that time, Washington had not yet adopted its own criteria for the protection of human health.6 On August 1, 2016, Washington adopted and submitted statewide human health criteria and new and revised implementation provisions. Concurrent with this final rule, EPA approved 45 and disapproved 143 of Washington’s human health criteria under CWA 303(c). EPA is finalizing 144 human health criteria in this rule in accordance 5 Final Updated Ambient Water Quality Criteria for the Protection of Human Health, (80 FR 36986, June 29, 2015). See also: USEPA. 2015. Final 2015 Updated National Recommended Human Health Criteria. U.S. Environmental Protection Agency, Office of Water, Washington, DC https:// www.epa.gov/wqc/human-health-water-qualitycriteria. 6 Washington adopted criteria for the protection of aquatic life from toxic pollutants at WAC 173– 201A–240. PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 85419 with CWA section 303(c)(3) and (c)(4) requirements.7 After the effective date of this final rule, these federal criteria will be in effect for CWA purposes along with the human health criteria that Washington adopted and EPA approved. Several commenters provided comments on the timing of EPA’s rule, and the relationship between EPA’s federal rulemaking and the state rulemaking process. These comments are now, for the most part, mooted by EPA’s finalization of its federal rule and action on the state’s submittal. For additional responses to specific comments, see EPA’s Response to Comment document in the docket for this rule. C. General Recommended Approach for Deriving Human Health Criteria Human health criteria are designed to minimize the risk of adverse cancer and non-cancer effects occurring from lifetime exposure to pollutants through the ingestion of drinking water and consumption of fish and shellfish obtained from inland and nearshore waters (by nearshore waters, EPA refers to waters out to three miles from the coast). EPA’s practice is to establish a human health 304(a) recommended criterion for both drinking water and consumption of fish and shellfish from inland and nearshore waters combined, and a separate human health criterion based only on ingestion of fish and shellfish from inland and nearshore waters. This latter criterion applies in cases where the designated uses of a waterbody include supporting fish and shellfish for human consumption but not drinking water supply sources (e.g., in non-potable estuarine waters). The criteria are based on two types of biological endpoints: (1) Carcinogenicity and (2) systemic toxicity (i.e., all adverse effects other than cancer). EPA takes an integrated approach and considers both cancer and non-cancer effects when deriving human health criteria. Where sufficient data are available, EPA derives criteria using 7 EPA is finalizing a different number of human health criteria (144) than it is disapproving (143) in Washington’s 2016 submittal. Washington did not adopt organism-only criteria for methylmercury or water-plus-organism and organism-only criteria for bis(2-chloro-1-methylethyl) ether. These are priority pollutants listed pursuant to CWA section 307(a)(1) for which EPA has 304(a) recommended criteria, and, as such, CWA section 303(c)(2)(B) requires that states adopt numeric criteria for these pollutants, as necessary to support the states’ designated uses. Therefore, EPA is including these three criteria in this final rule for Washington. This final rule, however, does not include revised water-plusorganism and organism-only criteria for arsenic, as explained below in section III.A, even though EPA is disapproving the arsenic criteria in Washington’s submittal. E:\FR\FM\28NOR1.SGM 28NOR1 85420 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations both carcinogenic and non-carcinogenic toxicity endpoints and recommends the lower value. Human health criteria for carcinogenic effects are calculated using the following input parameters: Cancer slope factor (CSF), cancer risk level, body weight, drinking water intake rate, fish consumption rate, and a bioaccumulation factor(s). Human health criteria for non-carcinogenic and nonlinear carcinogenic effects are calculated using a reference dose (RfD) in place of a CSF and cancer risk level, and a relative source contribution (RSC) factor, which is intended to ensure that an individual’s total exposure to a given pollutant from all sources does not exceed the RfD. Each of these inputs is discussed in more detail below and in EPA’s 2000 Human Health Methodology (hereafter referred to as EPA’s ‘‘2000 Methodology’’).8 a. Cancer Risk Level mstockstill on DSK3G9T082PROD with RULES EPA’s 304(a) national recommended human health criteria are typically based on the assumption that carcinogenicity is a ‘‘non-threshold phenomenon,’’ which means that there are no ‘‘no-effect’’ levels, because even extremely small doses are assumed to cause a finite increase in the incidence of cancer. Therefore, EPA calculates 304(a) human health criteria for carcinogenic effects as pollutant concentrations corresponding to lifetime increases in the risk of developing cancer.9 EPA calculates its 304(a) human health criteria values at a 10¥6 (one in one million) cancer risk level and recommends cancer risk levels of 10¥6 or 10¥5 (one in one hundred thousand) for the general population.10 EPA notes that states and authorized tribes can also choose a more stringent risk level, such as 10¥7 (one in ten million), when deriving human health criteria. 8 USEPA. 2000. Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA–822– B–00–004. https://www.epa.gov/wqc/humanhealth-water-quality-criteria. 9 As noted above, EPA recommends the criterion derived for non-carcinogenic effects if it is more protective (lower) than that derived for carcinogenic effects. 10 EPA’s 2000 Methodology also states: ‘‘Criteria based on a 10¥5 risk level are acceptable for the general population as long as states and authorized tribes ensure that the risk to more highly exposed subgroups (sport fishers or subsistence fishers) does not exceed the 10¥4 level.’’ Since EPA is establishing final criteria to protect a target general population of tribes with reserved subsistence fishing rights in Washington waters, the applicable EPA-recommended cancer risk levels would relate to that target general population, as opposed to the general population of Washington residents overall. See section III for additional discussion. VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 If the pollutant is not considered to have the potential for causing cancer in humans (i.e., systemic toxicants), EPA assumes that the pollutant has a threshold (the RfD) below which a physiological mechanism exists to avoid or overcome the adverse effects of the pollutant. b. Cancer Slope Factor and Reference Dose A dose-response assessment is required to understand the quantitative relationships between exposure to a pollutant and the onset of human health effects. EPA evaluates dose-response relationships derived from animal toxicity and human epidemiological studies to derive dose-response metrics. For carcinogenic toxicological effects, EPA uses an oral CSF to derive human health criteria. The oral CSF is an upper bound, approximating a 95 percent confidence limit, on the increased cancer risk from a lifetime oral exposure to a stressor. For non-carcinogenic effects, EPA uses the RfD to calculate human health criteria. A RfD is an estimate of a daily oral exposure of an individual to a substance that is likely to be without an appreciable risk of deleterious effects during a lifetime. A RfD is typically derived from a laboratory animal dosing study in which a no-observed-adverse-effect level (NOAEL), lowest-observed-adverseeffect level (LOAEL), or benchmark dose can be obtained. Uncertainty factors are applied to reflect the limitations of the data. EPA’s Integrated Risk Information System (IRIS) 11 was the primary source of toxicity values (i.e., RfD and CSF) for EPA’s 2015 updated 304(a) human health criteria.12 For some pollutants, however, more recent peer-reviewed and publicly available toxicological data were available from other EPA program offices (e.g., Office of Pesticide Programs, Office of Water, Office of Land and Emergency Management), other national and international programs, and state programs. c. Exposure Assumptions EPA’s latest 304(a) national human health criteria use a default drinking water intake rate of 2.4 liters per day (L/ day) and default rate of 22 g/day for 11 USEPA. Integrated Risk Information System (IRIS). U.S. Environmental Protection Agency, Office of Research and Development, Washington, DC www.epa.gov/iris. 12 Final Updated Ambient Water Quality Criteria for the Protection of Human Health, (80 FR 36986, June 29, 2015). See also: USEPA. 2015. Final 2015 Updated National Recommended Human Health Criteria. U.S. Environmental Protection Agency, Office of Water, Washington, DC https:// www.epa.gov/wqc/human-health-water-qualitycriteria. PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 consumption of fish and shellfish from inland and nearshore waters, multiplied by pollutant-specific bioaccumulation factors (BAFs) to account for the amount of the pollutant in the edible portions of the ingested species. EPA’s 2000 Methodology for deriving human health criteria emphasizes using, when possible, measured or estimated BAFs, which account for chemical accumulation in aquatic organisms from all potential exposure routes.13 In the 2015 national 304(a) human health criteria update, EPA primarily used field-measured BAFs, and laboratorymeasured bioconcentration factors (BCFs) with applicable food chain multipliers available from peerreviewed, publicly available databases, to develop national BAFs for three trophic levels of fish. If this information was not available, EPA selected octanolwater partition coefficients (Kow values) from peer-reviewed sources for use in calculating national BAFs.14 EPA’s national default drinking water intake rate of 2.4 L/day represents the per capita estimate of combined direct and indirect community water ingestion at the 90th percentile for adults ages 21 and older.15 EPA’s national default FCR of 22 g/day represents the 90th percentile consumption rate of fish and shellfish from inland and nearshore waters for the U.S. adult population 21 years of age and older, based on National Health and Nutrition Examination Survey (NHANES) data from 2003 to 2010.16 17 EPA calculates 13 USEPA. 2000. Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA–822– B–00–004. https://www.epa.gov/wqc/humanhealth-water-quality-criteria. 14 Final Updated Ambient Water Quality Criteria for the Protection of Human Health, (80 FR 36986, June 29, 2015). See also: USEPA. 2015. Final 2015 Updated National Recommended Human Health Criteria. U.S. Environmental Protection Agency, Office of Water, Washington, DC https:// www.epa.gov/wqc/human-health-water-qualitycriteria. 15 USEPA. 2011. EPA Exposure Factors Handbook. 2011 edition (EPA 600/R–090/052F). https://cfpub.epa.gov/ncea/risk/ recordisplay.cfm?deid=236252. 16 USEPA. 2014. Estimated Fish Consumption Rates for the U.S. Population and Selected Subpopulations (NHANES 2003–2010). United States Environmental Protection Agency, Washington, DC EPA 820–R–14–002. 17 EPA’s national FCR is based on the total rate of consumption of fish and shellfish from inland and nearshore waters (including fish and shellfish from local, commercial, aquaculture, interstate, and international sources). This is consistent with a principle that each state does its share to protect people who consume fish and shellfish that originate from multiple jurisdictions. USEPA. January 2013. Human Health Ambient Water Quality Criteria and Fish Consumption Rates: Frequently Asked Questions. https://www.epa.gov/ wqc/human-health-ambient-water-quality-criteriaand-fish-consumption-rates-frequently-asked. E:\FR\FM\28NOR1.SGM 28NOR1 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations human health criteria using a default body weight of 80 kilograms (kg), the average weight of a U.S. adult age 21 and older, based on NHANES data from 1999 to 2006. Although EPA uses these default values to calculate national 304(a) recommended human health criteria, EPA’s 2000 Methodology notes a preference for the use of local data to calculate human health criteria (e.g., locally derived FCRs, drinking water intake rates and body weights, and waterbody-specific bioaccumulation rates) over national default values, where data are sufficient to do so, to better represent local conditions.18 It is also important, where sufficient data are available, to select a FCR that reflects consumption that is not suppressed by concerns about the safety of available fish.19 20 Deriving human health criteria using an unsuppressed FCR furthers the restoration goals of the CWA and ensures protection of human healthrelated designated uses (as pollutant levels decrease, fish habitats are restored, and fish availability increases over time). See section III for additional discussion regarding use of an unsuppressed FCR to protect a subsistence or sustenance fishing use, especially where the subsistence or sustenance use is based in whole or in part on tribal treaty or other reserved fishing rights.21 mstockstill on DSK3G9T082PROD with RULES d. Relative Source Contribution When deriving human health criteria for non-carcinogens and nonlinear carcinogens, EPA recommends including a RSC factor to account for sources of exposure other than drinking water and fish and shellfish from inland and nearshore waters, so that the pollutant effect threshold (i.e., RfD) is not apportioned to drinking water and fish consumption alone. The rationale for this approach is that for pollutants exhibiting threshold effects, the objective of the human health criteria is to ensure that an individual’s total 18 USEPA. 2000. Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA–822– B–00–004. https://www.epa.gov/wqc/humanhealth-water-quality-criteria. 19 USEPA. January 2013. Human Health Ambient Water Quality Criteria and Fish Consumption Rates: Frequently Asked Questions. https://www.epa.gov/ wqc/human-health-ambient-water-quality-criteriaand-fish-consumption-rates-frequently-asked. 20 National Environmental Justice Advisory Council, Fish Consumption and Environmental Justice, p.44 (2002) available at https:// www.epa.gov/sites/production/files/2015-02/ documents/fish-consump-report_1102.pdf. 21 The term ‘‘subsistence’’ is coterminous with ‘‘sustenance’’ in this context. Hereafter, the document uses the term ‘‘subsistence.’’ VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 exposure from all sources does not exceed that threshold level. These other exposures include exposure to a particular pollutant from ocean fish and shellfish consumption (which is not included in EPA’s default national FCR), non-fish food consumption (e.g., fruits, vegetables, grains, meats, poultry), dermal exposure, and inhalation exposure. EPA’s guidance includes a procedure for determining an appropriate RSC value ranging from 0.2 to 0.8 for a given pollutant. III. Derivation of Human Health Criteria for Washington A. Scope of Pollutants and Waters Covered by This Final Rule In 1992, EPA did not establish human health criteria in the NTR for some priority toxic pollutants because, as stated in the preamble to the final rule at 57 FR 60848, December 22, 1992, EPA had no 304(a) recommendations for those pollutants at the time. EPA now has 304(a) recommendations for 99 priority toxic pollutants listed pursuant to CWA section 307(a)(1) (85 for which EPA established criteria in the NTR, plus 14 additional pollutants). After consideration of all comments received on EPA’s proposed rule, and EPA’s CWA 303(c) action on Washington’s submittal, EPA is finalizing 144 new and revised Washington-specific criteria for priority toxic pollutants in this rule. For arsenic, dioxin and thallium, EPA is not revising Washington’s existing criteria from the NTR at this time, as explained below and in EPA’s Response to Comments document in the docket for the final rule. For those priority pollutants for which EPA does not have 304(a) national recommended criteria, and are therefore not included in Washington’s submittal or this final rule, EPA expects that Washington will continue to apply its existing narrative toxics criterion in the state’s WQS at WAC 173–201A– 260(2)(a). Several commenters raised concerns about the scientific defensibility of EPA’s proposed human health criteria for arsenic, and one commenter raised similar concerns about EPA’s proposed criteria for 2,3,7,8–TCDD (dioxin). Additionally, after EPA proposed revised human health criteria for thallium in Washington, EPA further evaluated the scientific uncertainty around the appropriate RfD for thallium. EPA carefully considered all of these comments and information regarding these three pollutants, along with the comments that articulated it is important for Washington to have protective numeric criteria in place for PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 85421 priority toxic pollutants such as arsenic and dioxin. Given the scientific uncertainty regarding aspects of the science upon which the proposed human health criteria for arsenic, dioxin, and thallium were based, EPA is withdrawing its proposal of revised criteria for these three pollutants at this time and leaving the existing criteria from the NTR in effect for CWA purposes.22 EPA did not update the 304(a) national recommended criteria for these three pollutants in 2015. As noted earlier, IRIS was the primary source of toxicity values (i.e., RfD and CSF) for EPA’s 2015 updated 304(a) human health criteria. For thallium, EPA’s IRIS database does not currently contain an estimate of thallium’s toxicity (i.e., a RfD).23 For dioxin, IRIS does not currently contain a measure of dioxin’s cancer-causing ability (i.e., a CSF).24 Without such values, EPA has concluded that further analysis is necessary in order to promulgate scientifically sound revised criteria for these two pollutants. For arsenic, there is uncertainty surrounding the toxicological assessment with respect to human health effects. EPA’s current plan for addressing the arsenic issues is described in the Assessment Development Plan for the Integrated Risk Information System (IRIS) Toxicological Review of Inorganic Arsenic (EPA/630/R–14/101, November 2015). EPA intends to reevaluate the existing federal arsenic, dioxin and thallium human health criteria for Washington by 2018, with particular consideration of any relevant toxicity and bioaccumulation information. This rule revises the criteria that EPA promulgated for Washington in the NTR (with the exception of criteria for arsenic, dioxin, and thallium, and criteria that EPA approved in Washington’s August 1, 2016 submittal), and establishes new human health criteria for 8 additional chemicals for which EPA now has 304(a) recommended criteria (and for which EPA did not approve Washington’s submitted criteria): Selenium, Zinc, 1,2Trans-Dichloroethylene, Acenaphthene, Butylbenzyl Phthalate, 2Chloronaphthalene, 1,1,1Trichloroethane, and 1,2,4Trichlorobenzene. In 2001, EPA 22 EPA is moving Washington’s existing arsenic, dioxin and thallium criteria from the NTR into 40 CFR 131.45 to have one comprehensive human health criteria rule for Washington. 23 https://cfpub.epa.gov/ncea/iris/index.cfm ?fuseaction=iris.showQuickView&substance_ nmbr=1012. 24 https://cfpub.epa.gov/ncea/iris/index.cfm ?fuseaction=iris.showQuickView&substance_ nmbr=1024. E:\FR\FM\28NOR1.SGM 28NOR1 85422 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES replaced its 304(a) recommended human health criteria for total mercury with a fish tissue-based human health criterion for methylmercury.25 Washington did not include human health criteria for mercury or methylmercury in its August 1, 2016 submittal. Therefore, with this final rule, EPA replaces the criteria for total mercury that EPA promulgated for Washington in the NTR with a methylmercury fish tissue criterion, based on EPA’s 2001 304(a) recommendation but adjusted to incorporate the 175 g/day FCR that EPA used to derive revised human health criteria in Washington, as well as EPA’s 2015 updated national default body weight of 80 kg. A few commenters expressed concern that Washington would not have the data or implementation guidance to properly implement a fish tissue criterion for methylmercury, and requested that EPA leave the NTR total mercury criteria in effect in Washington. The fish tissue methylmercury criterion reflects EPA’s 2000 Methodology, the best available science, and supersedes all previous 304(a) human health mercury criteria recommendations published by EPA (except for the waters of the Great Lakes System), including the 304(a) recommended criteria that served as the basis for the total mercury criteria that EPA promulgated for Washington in the NTR. EPA recommends a fish tissue water quality criterion for methylmercury for many reasons. A fish tissue water quality criterion integrates spatial and temporal complexity that occurs in aquatic systems and affects methylmercury bioaccumulation. For this pollutant, a fish tissue criterion is more closely tied to the goal of protecting human health because it is based directly on the dominant human exposure route for methylmercury in the U.S., which is consumption of fish and shellfish. The concentration of methylmercury is also generally easier to quantify in fish tissue than in water and is less variable in fish and shellfish tissue over the time periods in which WQS are typically implemented in water quality-based controls, such as NPDES permits. Finally, fish consumption advisories for mercury are also based on the amount of methylmercury in fish tissue.26 While 25 USEPA. 2001. Guidance for Implementing the January 2001 Methylmercury Water Quality Criterion. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA–823–R–01– 001. https://www.epa.gov/wqc/guidanceimplementing-january-2001-methylmercury-waterquality-criterion. 26 While both water quality criteria and fish consumption advisories are designed ultimately to VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 the purpose of a fish advisory is different from the purpose of a water quality criterion, it will be helpful to the public to have water quality criteria and fish consumption advisories for methylmercury expressed using the same terms. In response to comments regarding implementation of the methylmercury criterion, in 2010, EPA published the comprehensive Guidance for Implementing the January 2001 Methylmercury Water Quality Criterion (EPA 823–R–10–001), to aid states in implementing the fish tissue-based methylmercury water quality criterion. EPA is confident that Washington will be able to implement the fish tissue criterion using the information contained in that document, and EPA remains available to offer assistance in doing so. Thus there is no need or requirement to leave the NTR total mercury criteria in place in Washington. This final rule does not change or supersede any criteria that EPA previously promulgated for other states in the NTR, nor does it change any other elements of the NTR such as EPA’s original basis for promulgation. For clarity in organization, EPA is withdrawing Washington from the NTR at 40 CFR 131.36 and incorporating the Washington-specific criteria in this rule (as well as the existing NTR criteria for arsenic, dioxin and thallium) into 40 CFR 131.45 so there is a single comprehensive set of federally promulgated criteria for Washington. This rule applies to waters under the State of Washington’s jurisdiction, and not to waters within Indian country,27 unless otherwise specified in federal law. Some waters located within Indian country already have CWA-effective human health criteria, while others do not.28 Several tribes are working with EPA to either revise their existing CWAeffective WQS, or obtain treatment in a similar manner as a state (TAS) status in order to adopt CWA-effective WQS in the near future. EPA will continue to work closely with tribes in Washington to ensure that they adopt human health protect human health, they represent very different values and goals. Water quality criteria express or establish a desired condition and must protect the designated use, such as subsistence fishing. Fish consumption advisories start with existing levels of fish contamination resulting from impaired water quality, and provide advice to populations consuming such fish on limiting levels of consumption in order to reduce risk from contamination. 27 See 18 U.S.C. 1151 for the definition of Indian country. 28 Indian country waters with CWA-effective WQS include those where (a) EPA has authorized a tribe to adopt WQS under the CWA for its reservation and the tribe has adopted standards that EPA has approved, and (b) EPA has promulgated federal WQS. PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 criteria that are scientifically supported and protective of designated uses, in accordance with the CWA and EPA’s regulations. In addition, on September 29, 2016, EPA published an Advanced Notice of Proposed Rulemaking in the Federal Register that seeks input on an approach that involves EPA promulgating baseline WQS for reservations that currently have no CWA-effective WQS, including such reservations within the State of Washington.29 B. Washington’s Designated Uses and Tribal Reserved Fishing Rights a. EPA’s Consideration of Tribal Treaty Rights Under the Supremacy Clause of the U.S. Constitution, federal treaties have the same legal force as federal statutes.30 As such, the provisions of federal statutes should generally be read in harmony with treaties where they both apply. In certain instances, statutes may contain provisions indicating that they must be read in harmony with treaties. Such is the case with the CWA, which provides that the Act ‘‘shall not be construed as . . . affecting or impairing the provisions of any treaty of the United States.’’ 31 In determining whether WQS satisfy the CWA and EPA’s regulations, and when setting criteria for the protection of human health, it is necessary to consider other applicable laws, such as federal treaties (e.g., U.S. Treaties with Indians). While treaties do not expand EPA’s authority, they are binding on the federal government. As a result, EPA has an obligation to ensure that its actions do not conflict with tribal treaty rights.32 For the foregoing reasons, and 29 For more information, see: https:// www.epa.gov/wqs-tech/advance-notice-proposedrulemaking-federal-baseline-water-qualitystandards-indian. 30 U.S. Const. art. IV, § 2: The ‘‘Constitution . . . of the United States . . . and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.’’ 31 CWA Section 511, 33 U.S.C. 1371. 32 U.S. Const. art. IV, § 2; see United States v. Forty-Three Gallons of Whiskey, 93 U.S. 188, 196 (1833) (recognizing that ‘‘the Constitution declares a treaty to be the supreme law of the land,’’ and that ‘‘a treaty is to be regarded . . . as equivalent to an act of the legislature’’) and Worcester v. Georgia, 31 U.S. 515, 594 (1832) (‘‘So long as . . . treaties exist, having been formed within the sphere of the federal powers, they must be respected and enforced by the appropriate organs of the federal government.’’). See also EPA policies on considering treaty rights: Working Effectively With Tribal Governments: Resource Guide at pp. 49–52, 53 (August 1998) (explaining the key principles underlying the application of Indian treaty rights, and noting that ‘‘[f]ederal, state, and local agencies need to refrain E:\FR\FM\28NOR1.SGM 28NOR1 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations as further explained below, it is therefore necessary and appropriate to consider tribal treaties to ensure that EPA’s actions under the CWA are in harmony with such treaties. See also EPA’s Response to Comment document in the docket for this rule. mstockstill on DSK3G9T082PROD with RULES b. Treaty-Reserved Subsistence Fishing Rights in Washington The majority of waters under the jurisdiction of the State of Washington are subject to federal treaties with tribes.33 There are eight Stevens-Palmer Treaties relevant to the State of Washington through which 24 tribes reserved for themselves identical or nearly identical fishing rights within the boundaries of present-day Washington; specifically, the treaty-reserved ‘‘right of taking fish at usual and accustomed places, in common with all citizens of the Territory.’’ 34 The right to take fish at usual and accustomed places extends to lands formerly ceded by the tribes to the U.S. as described in the treaties, as well as to all places beyond the boundaries of the ceded territories that tribal members regularly used at treaty time.35 The parties to the treaties all recognized the importance of the fishing right for the tribes’ subsistence, ceremonial, as well as commercial from taking actions that are not consistent with tribal rights wherever they exist’’); Commemorating the 30th Anniversary of the EPA’s Indian Policy, Memorandum from Gina McCarthy to All EPA Employees, p. 1 (December 1, 2014) (reiterating that ‘‘EPA must ensure that its actions do not conflict with tribal treaty rights’’ and stating that ‘‘EPA programs should be implemented to enhance the protection of tribal treaty rights and treaty-covered resources when we have the discretion to do so’’); EPA Policy for the Administration of Environmental Programs on Indian Reservations (November 8, 1984) (known as ‘‘EPA 1984 Indian Policy’’). 33 See https://wdfw.wa.gov/hunting/tribal/treaty_ history.html. 34 See e.g. Treaty with the Yakima art. 3, June 9, 1855, 12 Stat. 951. In United States v. Winans, 198 U.S. 371 (1905), the Supreme Court adopted a ‘‘reservation of rights’’ approach in interpreting the Stevens Treaty with the Yakima Nation: ‘‘the treaty was not a grant of rights to the Indians, but a grant of rights from them—a reservation of those not granted.’’ Id. at 381. In contrast, ‘‘off reservation fishing by other citizens and residents of the state is not a right but merely a privilege which may be granted, limited or withdrawn by the state as the interests of the state or the exercise of treaty fishing rights may require.’’ U.S. v Washington, 384 F. Supp. 312, 332 (W.D. Wash. 1974) aff’d 520 F.2d 676 (9th Cir. 1975), cert. denied 423 U.S. 1086 (1976). 35 See Seufert Bros. Co. v. U.S., 249 U.S. 194, 199 (1919). In U.S. v Washington, the court stated, citing Seufert Bros. Co., ‘‘every fishing location where members of a tribe customarily fished from time to time at and before treaty times, however distant from the then usual habitat of the tribe, and whether or not other tribes then also fished in the same waters, is a usual and accustomed ground or station at which the treaty tribe reserved, and its members presently have, the right to take fish.’’ 384 F. Supp. at 332. VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 purposes.36 In U.S. v Washington, the district court made detailed findings of facts regarding the reserved fishing right, including the importance of subsistence fishing to the treaty tribes: At the treaty negotiations, a primary concern of the tribes, whose way of life was so heavily dependent upon harvesting anadromous fish, was that they have freedom to move about to gather food, particularly salmon, . . . at their usual and accustomed fishing places. . . . Subsequent to the execution of the treaties and in reliance thereon, the members of the [treaty tribes with reserved fishing rights in Washington] have continued to fish for subsistence, sport, and commercial purposes at their usual and accustomed places. Such fishing provided and still provides an important part of their livelihood, subsistence and cultural identity. The Indian cultural identification with fishing is primarily dietary, related to the subsistence fishery, and secondarily associated with religious ceremonies and commercial fishing.37 Relevant case law, including Supreme Court precedents, unequivocally confirms that the treaty-reserved right to take fish includes the right to take fish for subsistence purposes.38 Historical and current evidence of tribal members’ 36 For a thorough discussion on the treaty negotiation and execution and meaning of the reserved fishing right, see e.g., U.S. v Washington, 384 F. Supp. at 348–359 (containing finding of facts regarding, inter alia, treaty status, pre-treaty role of fishing among northwest Indians, treaty background, negotiation and execution of the treaties, and post-treaty Indian fishing); see also id. at 340 (‘‘The right to fish for all species available in the waters from which, for so many ages, their ancestors derived most of their subsistence is the single most highly cherished interest and concern of the present members of plaintiff tribes, with rare exceptions even among tribal members who personally do not fish or derive therefrom any substantial amount of their subsistence.’’); id. at 343 (‘‘The evidence shows beyond doubt that at treaty time the opportunity to take fish for personal subsistence and religious ceremonies was the single matter of utmost concern to all treaty tribes and their members.’’); and U.S. v. Washington, No. 13– 35474, 2016 U.S. App. LEXIS 11709, at *29 (9th Cir. June 27, 2016) (‘‘The Indians reasonably understood Governor Stevens to promise not only that they would have access to their usual and accustomed fishing places, but also that there would be fish sufficient to sustain them.’’). 37 U.S. v Washington, 384 F. Supp. at 355–358 (internal citations to exhibits omitted). 38 See e.g., Washington v. Washington State Commercial Passenger Fishing Vessel Ass’n, 443 U.S. 658, 678–679 (1979) (Because the Indians had always exercised the right to meet their subsistence and commercial needs by taking fish from treaty area waters, they would be unlikely to perceive a ‘‘reservation’’ of that right as merely the chance, shared with millions of other citizens, occasionally to dip their nets into the territorial waters. Moreover, the phrasing of the clause quite clearly avoids placing each individual Indian on an equal footing with each individual citizen of the State.’’); U.S. v. Washington, 2016 U.S. App. LEXIS 11709 at *28 (Observing that to the Tribes, the Stevens Treaties’ ‘‘principal purpose was to secure a means of supporting themselves once the Treaties took effect,’’ and to that end, ‘‘[s]almon were a central concern.’’). PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 85423 exercise of the treaty-reserved subsistence fishing right can be found in heritage FCR reports and contemporary FCR surveys (for tables of relevant FCRs, see EPA’s Response to Comment document in the docket for this rule). As explained above, the StevensPalmer Treaties provide tribes the right to exercise subsistence fishing practices on waters throughout the State of Washington. EPA concludes that the purpose for which tribes reserved such fishing rights through treaties with the U.S. has important implications for water quality regulation under the CWA. Fundamentally, the tribes’ ability to take fish for their subsistence purposes under the treaties would be substantially affected or impaired if it were not supported by water quality sufficient under the CWA to ensure that tribal members can safely eat the fish for their own subsistence. Many areas where treaty-reserved fishing rights are exercised cannot be directly protected or regulated by tribal governments to ensure adequate water quality, and therefore the responsibility falls to the federal government (and the states) to ensure their protection. It is therefore appropriate and necessary for EPA (and states) to consider the tribal reserved rights within the framework of the CWA, to ensure water quality protection for treaty-reserved subsistence fishing rights. EPA’s consideration of treaty-reserved fishing rights within the framework of the CWA leads to the conclusion, as described below, that the human health fishing uses for waters in Washington include subsistence fishing, as informed by the tribes’ legally protected right to continue to take fish for subsistence purposes.39 39 While EPA’s action is based on harmonizing the requirements of the CWA with the terms of the treaty-reserved subsistence fishing right, the action also is consistent with federal Indian law principles addressing subsidiary treaty rights. A written legal opinion from the Solicitor of the U.S. Department of Interior (DOI) to EPA analyzed whether tribal reserved fishing rights include subsidiary rights to sufficient water quality. Letter from Hilary C. Tompkins, Solicitor, DOI, to Avi Garbow, General Counsel, EPA, regarding Maine’s WQS and Tribal Fishing Rights of Maine Tribes (January 30, 2015). Although DOI’s legal opinion primarily involved an analysis of fishing rights of tribes in Maine in connection with EPA’s February 2, 2015 decision to disapprove WQS applied to waters of Indian Lands in Maine, its discussion of tribal fishing rights and water quality has relevance to tribes with reserved fishing rights in Washington. DOI’s legal opinion identified several court decisions, including Supreme Court decisions interpreting the reserved fishing right in the Stevens Treaties, which have held that fishing rights for tribes encompass subsidiary rights that are necessary to render those rights meaningful. In Washington v. Wash. State Commercial Passenger Fishing Vessel Ass’n, the United States Supreme Court held that tribes with E:\FR\FM\28NOR1.SGM Continued 28NOR1 85424 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES c. Use(s) of the Water(s) in Question Consistent with EPA’s September 14, 2015 proposed rule for Washington, in order to effectuate and harmonize treaty-reserved fishing rights with the CWA, EPA has determined that such rights must be appropriately considered when determining which criteria are sufficient to adequately protect Washington’s designated uses. Looking at the treaty-reserved subsistence fishing right within the CWA water quality framework, the first step is to examine the use of the water(s) in question. The CWA generally assigns to a state the responsibility of determining the designated uses of its waters (subject to certain restrictions at 40 CFR 131.10),40 and in Washington the state’s designated uses include fish and shellfish harvesting.41 As explained above, through treaties, tribes reserved specific fishing rights in Washington’s waters, including the right to take fish from such waters for their subsistence. In order to effectuate these rights in harmony with the CWA, EPA has interpreted the state’s EPA-approved designated fish and shellfish harvesting use to include or encompass a reserved fishing rights are entitled to something more tangible than ‘‘merely the chance . . . occasionally to dip their nets into the territorial seas.’’ 443 U.S. 658, 679 (1979). Consistent with this reasoning, courts have held that treaty-reserved fishing rights entail the right to access fishing grounds and the right to water quantity sufficient to support fish habitat. See e.g., United States v. Winans, 198 U.S. 371, 384 (1905) (tribe must be allowed to cross private property to access traditional fishing ground); Seufert Bros. Co. v. United States, 249 U.S. 194 (1919) (tribe entitled to cross over and temporarily use any sites which they were accustomed to using at treaty time, including sites outside their ceded territories); United States v. Adair, 723 F .2d 1394, 1409–10 (9th Cir. 1983) (holding that the tribe’s fishing right implicitly reserved sufficient waters to ‘‘secure to the Tribe a continuation of its traditional . . . fishing lifestyle’’; Colville Confederated Tribes v. Walton, 647 F.2d 42, 47–48 (9th Cir. 1981) (implying reservation of water to preserve tribe’s replacement fishing grounds). Consistent with these precedents, in June 2016 the U.S. Court of Appeals for the Ninth Circuit affirmed the district court’s finding that barrier culverts constructed by the State of Washington obstructing fish passage were in violation of tribal fishing rights set forth in the Stevens Treaties, noting that ‘‘the Tribes’ right of access to their usual and accustomed fishing places would be worthless without harvestable fish.’’ United States v. Washington, 2016 U.S. App. LEXIS 11709 at *31. The court also acknowledged that the fishing clause of the Stevens Treaties could give rise to other environmental obligations, but that those would need to be addressed on a case-by-case basis depending on the precise nature of the action. Id. at *18–19. Consistent with this body of case law, DOI’s legal opinion concludes that ‘‘fundamental, longstanding tenets of federal Indian law support the interpretation of tribal fishing rights to include the right to sufficient water quality to effectuate the fishing right.’’ DOI Letter at 10. 40 33 U.S.C. 1251(a)(2), 1313(c)(2)(A). 41 See WAC 173–201A–600 and WAC 173–201A– 610. VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 subsistence fishing component based on, and consistent with, the rights reserved to the tribes through the treaties. As discussed in more detail below, EPA construes the CWA to require that, when establishing WQS for these waters, the tribal members must be considered the target general population for the purposes of setting risk levels to protect the subsistence fishing use. d. Target General Population for Deriving Criteria Protective of the Use(s) Developing criteria to protect the fish and shellfish harvesting use, which includes subsistence fishing as informed by reserved fishing rights, necessarily involves identifying tribal members with reserved fishing rights as the target population for protection. EPA’s conclusion to identify tribes as the target population is based on EPA’s CWA implementing regulations requiring criteria to support the most sensitive use (i.e., subsistence fishing) and EPA’s 2000 Methodology recommendation that priority be given to identifying and protecting highly exposed populations. Further, in order to derive water quality criteria sufficient under the CWA to ensure that the tribes’ treaty-reserved right to take fish for subsistence purposes is not substantially affected or impaired, it is reasonable and appropriate to identify tribes as the target general population for protection, rather than a subpopulation, and apply the 2000 Methodology’s recommendations on exposure for the general population to the tribal target population. Per EPA’s regulations at 40 CFR 131.11(a)(1), water quality criteria must contain sufficient parameters or constituents to protect the designated use, and for waters with multiple uses, the criteria must support the most sensitive use. In the case of Washington’s human health-related uses, the most sensitive use is fish and shellfish harvesting, which, as explained above, EPA has interpreted to include or encompass a subsistence fishing component based on, and consistent with, the rights reserved to the tribes through the treaties. Developing water quality criteria to protect the subsistence fishing component of the fish or shellfish harvesting use necessarily involves identifying the population exercising that use. EPA’s decision to identify tribes as the target population is further supported by EPA guidance for developing water quality criteria to protect human health. As explained in EPA’s 2000 Methodology, the choice of PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 the particular population to protect is an important decision to make when setting human health criteria.42 EPA recommends that states provide adequate protection from adverse health effects to the general population, as well as to highly exposed populations, such as recreational and subsistence fishers, two distinct groups with FCRs that may be greater than the general population.43 In fact, EPA’s 2000 Methodology recommends considering how to protect both susceptible and highly exposed populations when setting criteria: EPA recommends that priority be given to identifying and adequately protecting the most highly exposed population. Thus, if the State or Tribe determines that a highly exposed population is at greater risk and would not be adequately protected by criteria based on the general population, and by the national 304(a) criteria in particular, EPA recommends that the State or Tribe adopt more stringent criteria using alternative exposure assumptions.44 Therefore, consistent with the guidance, EPA identifies the tribal population as the target population for protection and the subsistence fishing use must be the focus of the risk assessment supporting water quality criteria to adequately protect that use. Deriving criteria protective of the tribal target population necessarily involves determining the appropriate inputs for calculating protective criteria for tribal subsistence fishers, such as the FCR and cancer risk level. EPA’s approach in the 2000 Methodology, and its approach used for deriving national 304(a) recommended criteria, is for human health water quality criteria to provide a high level of protection for the general population (for example, FCRs designed to represent ‘‘the general population of fish consumers,’’ or a cancer risk level that ‘‘reflects an appropriate risk for the general population’’), while recognizing that more highly exposed ‘‘subpopulations’’ may face greater levels of risk.45 The 2000 Methodology does not, however, speak to or envision the unique situation of setting WQS that cover areas where tribes have treatyreserved rights to practice subsistence 42 EPA’s 2000 Methodology, 2–1. at 2–2. 44 EPA’s 2000 Methodology, 2–1—2. See also EPA’s 2000 Methodology, 4–17 (‘‘When choosing exposure factor values to include in the derivation of a criterion for a given pollutant, EPA recommends considering values that are relevant to population(s) that is (are) most susceptible to that pollutant. In addition, highly exposed populations should be considered when setting criteria.’’). 45 See EPA’s 2000 Methodology, 2–6—7, 4–24— 25. 43 Id. E:\FR\FM\28NOR1.SGM 28NOR1 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES fishing.46 Nevertheless, it is possible to apply the general principles outlined in the 2000 Methodology to this situation, as informed by the treaties. In light of the presence of the treatyreserved fishing rights in Washington, interpreted by the U.S. Supreme Court to encompass, among other things, subsistence fishing, and EPA’s interpretation of Washington’s fish and shellfish harvesting use to include subsistence fishing, it is reasonable and appropriate to require that tribes with such rights be considered as the target general population for deriving criteria protective of the use rather than a sensitive subpopulation within the overall population of Washington. Treating tribes as the target general population will help derive water quality criteria sufficient under the CWA to ensure that the tribes’ treatyreserved right to take fish for subsistence purposes is not substantially affected or impaired. Therefore, the 2000 Methodology’s recommendations on exposure for the target general population can be applied accordingly. EPA’s conclusion to treat tribes as the target general population, as opposed to a subpopulation, is further supported by relevant case law interpreting the treaty-reserved fishing rights applicable in Washington; specifically the phrase ‘‘in common with all citizens of the territory.’’ Treating tribes as the target population instead of a sensitive subpopulation also impacts another important input parameter used to derive human health criteria, the cancer risk level. For carcinogenic pollutants, EPA’s 2000 Methodology recommends that states protect the general population to a level of incremental cancer risk no greater than one in one hundred thousand to one in one million (1 × 10¥5 to 10¥6). For over 20 years, Washington has used 10¥6 as the level of risk that must be used to establish human health criteria for carcinogenic pollutants. EPA’s 2000 Methodology indicates that if there are highly exposed groups or subpopulations within that target general population, such as subsistence consumers, WQS should protect those consumers to a 46 In response to comments on EPA’s 1998 draft Human Health Methodology revisions, the Agency responded: ‘‘As stated in the 1998 draft Methodology revisions, ‘risk levels and criteria need to be protective of tribal rights under federal law (e.g., fishing, hunting, or gathering rights) that are related to water quality.’ We believe the best way to ensure that Tribal treaty and other rights under Federal law are met, consistent with the Federal trust responsibility, is to address these issues at the time EPA reviews water quality standards submissions.’’ (See 65 FR 66444, 66457 November 3, 2000). VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 level of incremental risk no greater than one in ten thousand (1 × 10¥4).47 However, where treaty-reserved tribal fishing rights apply to particular waters, it would be unreasonable to expose the communities exercising those rights to levels of risk above what would be reasonable for the general population of the state. See section III.C.b for more information on cancer risk level. e. Water Quality Criteria Sufficient To Protect the Use(s) The data used to determine the FCR are critical to deriving criteria that will protect the subsistence fishing portion of the fish and shellfish harvesting designated use. EPA provides a recommended national default FCR for the general population but strongly recommends the use of local or regional data, where available, over default values.48 Further, as EPA explained in its January 2013 Human Health Ambient Water Quality Criteria and Fish Consumption Rates: Frequently Asked Questions, it is important to avoid selecting a FCR that reflects consumption that is suppressed due to concerns about the safety of available fish. Under certain circumstances, it may also be relevant to look at the availability of fish when considering suppression effects on current FCRs.49 EPA maintains that it is important, as a CWA goal, to avoid the suppression effect that may occur when criteria are derived using a FCR for a given target population that reflects an artificially diminished level of fish consumption from an appropriate baseline level of consumption for that population.50 To 47 2000 Methodology, 2–6. 2000 Methodology, 4–24—4–25 (‘‘EPA’s first preference is that States and authorized Tribes use the results from fish intake surveys of local watersheds within the State or Tribal jurisdiction to establish fish intake rates that are representative of the defined populations being addressed for the particular waterbody.’’) 49 As noted by the National Environmental Justice Advisory Council in the 2002 publication Fish Consumption and Environmental Justice, ‘‘a suppression effect may arise when fish upon which humans rely are no longer available in historical quantities (and kinds), such that humans are unable to catch and consume as much fish as they had or would. Such depleted fisheries may result from a variety of affronts, including an aquatic environment that is contaminated, altered (due, among other things, to the presence of dams), overdrawn, and/or overfished. Were the fish not depleted, these people would consume fish at more robust baseline levels. . . . In the Pacific Northwest, for example, compromised aquatic ecosystems mean that fish are no longer available for tribal members to take, as they are entitled to do in exercise of their treaty rights.’’). National Environmental Justice Advisory Council, Fish Consumption and Environmental Justice, p.44, 46 (2002) available at https://www.epa.gov/sites/ production/files/2015–02/documents/fishconsump-report_1102.pdf. 50 See id. at 43. 48 EPA’s PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 85425 use a FCR that is suppressed would not result in criteria that actually protect a fishing use because it would merely reinforce the existing suppressed use, or worse, set in motion a ‘‘downward spiral’’ 51 of further reduction/ suppression of fish consumption due to concerns about the safety of available fish or depleted fisheries. The CWA is meant not merely to maintain the status quo, but to restore and maintain the chemical, physical, and biological integrity of the Nation’s waters. Therefore, deriving criteria using an unsuppressed FCR furthers the restoration goals of the CWA and ensures protection of human healthrelated designated uses (as pollutant levels decrease, fish habitats are restored, and fish availability increases over time). CWA section 303(c)(2)(A) requires that water quality criteria be ‘‘based upon’’ applicable designated uses, and that such uses and criteria ‘‘shall be such as to protect the public health or welfare, enhance the quality of water and serve the purposes of this [Act].’’ The ‘‘purposes of this [Act]’’ are in section 101, and include, among other things, ‘‘to restore and maintain the chemical, physical, and biological integrity of the Nation’s waters’’ and ‘‘water quality which provides for the protection and propagation of fish, shellfish, and wildlife and provides for recreation in and on the water.’’ EPA’s implementing water quality regulations at 40 CFR 131.11 require water quality criteria to be based on sound scientific rationale and sufficient to protect the designated use, regardless of whether that use is currently being met. A subsistence fishing designated use, by definition, represents a level of fish consumption that is adequate to provide subsistence, regardless of whether such consumption is occurring today. It is entirely consistent with the CWA and regulations for EPA to determine that to protect the designated use, it is necessary and appropriate to derive the human health criteria using a fish consumption rate that reflects a subsistence level of consumption that is not artificially suppressed as a result of concerns about pollution or fish contamination where such data are available. Any fish consumption rate used in setting criteria to protect a subsistence fishing use must allow for the consumption of fish from local waters at levels that could sustain and be protective of members of the target population practicing a subsistence lifestyle. Water quality criteria derived 51 See E:\FR\FM\28NOR1.SGM id. at 47. 28NOR1 mstockstill on DSK3G9T082PROD with RULES 85426 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations using a FCR below a level that would be adequate to sustain members of the target population exercising a subsistence use, such as tribal members who have a history of subsistence fishing in Washington, would not be protective of that use. In this context, use of an unsuppressed rate, where data to determine that rate are available, would ensure that the resulting criteria are protective of the subsistence use. The importance of relying on an unsuppressed FCR, where data are available, is especially evident where the subsistence use is based in whole or in part on tribal treaty and other reserved subsistence fishing rights. This is because if human health criteria are set at a level that assumes only suppressed fish consumption, the waters will only be protected to support that level of suppressed fish consumption and thus never fully support—and potentially even may directly impair—the tribes’ legal right to take fish for subsistence purposes. Accordingly, where adequate data are available to clearly demonstrate what the current unsuppressed FCR is for the relevant target population, the selected FCR must reflect that value. In the absence of such data, states, tribes, and EPA could consider upper percentile FCRs of local contemporary fish consumption surveys (such as the 95th or 99th percentile), heritage FCR data for the target population, and/or FCRs that provide for a subsistence fishing lifestyle. Consultation with tribes is important to ensure that all data and information relevant to this issue are considered. Although treaties do not cover all waters in Washington, they cover the vast majority of the state’s waters. Additionally, where treaty and nontreaty reserved rights apply on waters downstream of waters without reserved fishing rights, upstream WQS must provide for the attainment and maintenance of downstream WQS in accordance with EPA’s regulations at 40 CFR 131.10(b). Based on a GIS analysis included in the docket for this final rulemaking, EPA concluded that greater than 90 percent of waters in Washington are covered by treaty rights and/or are upstream of waters with such rights or waters in Oregon (see section III.C.a). For any remaining waters in Washington, where reserved rights do not apply and that are not upstream of waters with such rights or waters in Oregon, it would be administratively burdensome to develop separate criteria to apply to such a small subset of waters, and would be difficult to implement separate criteria with a patchwork of protection among these VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 areas when administering the WQS, NPDES permitting, and other programs. Therefore, EPA applies these final criteria to all waters under Washington’s jurisdiction. Many commenters supported EPA’s decisions to derive criteria protective of the tribal population exercising their treaty-reserved fishing rights in Washington as the target general population, and to apply the resulting criteria to all waters under Washington’s jurisdiction. Many other commenters did not support these decisions, and argued that EPA did not have a scientific or legal basis to interpret Washington’s designated uses to encompass subsistence fishing and to treat the tribal population with treatyreserved fishing rights as the target general population for protection under such use. For additional responses to these comments, see EPA’s Response to Comment document in the docket for this rule. C. Washington-Specific Human Health Criteria Inputs a. Fish Consumption Rate In Washington there are 24 tribes with treaty-reserved fishing rights, rights that encompass the right to fish for subsistence purposes, and several local and regional FCR surveys and heritage tribal consumption reports with widely varying estimates of tribal FCRs in Washington (for tables of relevant FCRs, see EPA’s Response to Comment document in the docket for this rule). Available heritage FCRs range from 401 to 995 g/day, and contemporary survey FCRs range from 63 to 214 g/day (mean FCRs) and from 113 to 489 g/day (90th percentile FCRs). The discrepancy between contemporary and heritage FCRs suggests that current FCRs for certain tribal consumers in Washington may be suppressed.52 53 It is currently unclear how a contemporary fish consumption survey might quantitatively account for suppression, resulting in estimates of current FCRs that are unsuppressed to the maximum degree practicable. There is no local survey of contemporary fish consumption in Washington adjusted specifically to account for suppression, and no survey is a clear representation of current unsuppressed consumption 52 The number of fish advisories and closures due to contamination also suggest that contemporary FCRs may be suppressed due to concerns about pollution. See Washington Department of Health, Fish Consumption Advisories, available at https:// www.doh.wa.gov/CommunityandEnvironment/ Food/Fish/Advisories. 53 Heritage rates refer to the rates of fish intake consistent with traditional tribal practices, prior to contact with European settlers. PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 for all tribes in Washington. Consistent with the principles outlined above, EPA considered the available, scientifically sound fish consumption data for Washington tribes and consulted with tribal governments to select a FCR for this final rulemaking. The Washington tribes have generally agreed that 175 g/day is acceptable for deriving protective criteria at this time, when accompanied by other protective input parameters to calculate the criteria. However, EPA recognizes that some tribes have raised concerns as to whether a FCR of 175 g/day reasonably reflects current unsuppressed consumption rates of tribes within the State of Washington, based on the best currently available information. A FCR of 175 g/day approximates the 95th percentile consumption rate of surveyed tribal members from the CRITFC study 54 and includes anadromous fish, which is reasonable given that these marine species reside in Washington’s nearshore (i.e., within three miles of the coast) waters, especially Puget Sound, and accumulate pollutants discharged to these waters during a significant portion of their lives. The CRITFC survey also includes four tribes (three of which have treaty-reserved rights in Washington, the most of any one contemporary FCR survey in Washington) along the Columbia River in Washington, Idaho, and Oregon. Given this, and also considering the variability in heritage and contemporary FCRs and the uncertainty regarding suppression effects on current FCRs, the CRITFC survey provides scientifically sound estimates of fish consumption for the purpose of deriving a Washington statewide FCR for the tribal target general population. Additionally, Oregon, much of which is downstream from Washington (or cross-stream in the Columbia River where it forms the border between the two states), used a FCR of 175 g/day to derive statewide human health criteria, which EPA approved in 2011. Use of this FCR to derive Washington’s criteria will thus help ensure the attainment and maintenance of downstream WQS in Oregon. Many commenters supported EPA’s selected FCR, as well as the Agency’s position that it is important to consider suppression effects on the FCR in general, and necessary and appropriate to do so where subsistence fishing is a reserved right and encompassed by the designated use of the waters. Some 54 Fish Consumption Survey of the Umatilla, Nez Perce, Yakama, and Warm Springs Tribes of the Columbia River Basin (Columbia River Inter-Tribal Fish Commission (CRITFC), 1994). E:\FR\FM\28NOR1.SGM 28NOR1 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations commenters expressed concern that 175 g/day was not high enough to reflect current or historical consumption rates of all tribes in Washington. Many other commenters expressed the opposite concern, that 175 g/day was unreasonably high in order to protect Washington residents, and argued that treaty-reserved rights do not confer the right to eat fish at unsuppressed levels. Some of those commenters also argued that the CWA does not mention suppression. For detailed responses to these comments, see EPA’s Response to Comment document in the docket for this rule. mstockstill on DSK3G9T082PROD with RULES b. Cancer Risk Level EPA derives final human health criteria for carcinogens in Washington using a cancer risk level of one in one million (10¥6), based on Washington’s longstanding use of that cancer risk level, EPA guidance, tribal reserved fishing rights, and downstream protection requirements. To derive final human health criteria for each state in the NTR, EPA selected a cancer risk level based on each state’s policy or practice regarding what risk level should be used when regulating carcinogens in surface waters. In its official comments on EPA’s proposed NTR in 1992, Washington asked EPA to promulgate human health criteria using a cancer risk level of 10¥6, stating, ‘‘The State of Washington supports adoption of a risk level of one in one million for carcinogens. If EPA decides to promulgate a risk level below one in one million, the rule should specifically address the issue of multiple contaminants so as to better control overall site risks.’’ (57 FR 60848, December 22, 1992). Accordingly, in the NTR, EPA used a cancer risk level of 10¥6 (one in one million) to derive human health criteria for Washington. Subsequently, Washington adopted and EPA approved a provision in the state’s WQS that reads: ‘‘Risk-based criteria for carcinogenic substances shall be selected such that the upper-bound excess cancer risk is less than or equal to one in a million’’ (WAC 173–201A– 240(6)). In Washington’s August 1, 2016 submittal, the cancer risk level is identified in the new text and reformatted toxics criteria table at WAC 173–201A–240. Subsequent to promulgating the NTR, EPA issued its 2000 Methodology, which states that when promulgating water quality criteria for states and tribes, EPA intends to use the 10¥6 cancer risk level, which reflects an appropriate risk for the general VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 population.55 In this action, as described above, tribes with treatyreserved rights in Washington are the target general population for the purpose of deriving revised criteria to protect the subsistence fishing uses of Washington’s waters. Because those tribes are the general population in this case, EPA’s selection of a 10¥6 cancer risk level for the tribal target general population is consistent with current EPA guidance, specifically the 2000 Methodology. In addition, use of a cancer risk rate of 10¥6 ensures that the resulting human health criteria for carcinogens protect the subsistence fishing component of the designated use. Due to uncertainty regarding suppression effects (see sections II.C, III.B, and III.C.a, and EPA’s Response to Comment document in the docket for this rule), using a cancer risk level of 10¥6 along with a FCR of 175 g/day ensures that tribal members with treaty-reserved fishing rights will be protected at an acceptable risk level for the target general population. Throughout tribal consultation, the tribes generally supported 175 g/day as an acceptable FCR for purposes of revising Washington’s human health criteria at this time, when accompanied by other protective input parameters (e.g., a cancer risk level of 10¥6), to account for the uncertainty around an appropriate FCR value reflective of tribal subsistence fishing. Finally, as discussed in section III.C.a, many of Washington’s rivers are in the Columbia River Basin, upstream of Oregon’s portion of the Columbia River. Oregon’s criteria are based on a FCR of 175 g/day and a cancer risk level of 10¥6. EPA’s decision to derive human health criteria for Washington using a cancer risk level of 10¥6 along with a FCR of 175 g/day helps ensure that Washington’s criteria will ensure the attainment and maintenance of Oregon’s downstream WQS as required by 40 CFR 131.10(b). Many commenters supported EPA’s selection of a 10¥6 cancer risk level, and EPA’s rationale for doing so. Many other commenters disagreed and argued that deriving human health criteria for Washington using a 10¥5 cancer risk level is appropriate and consistent with EPA guidance and past practice. Many of these commenters stated that tribal treaties did not confer rights to a particular level of risk. Additionally, some commenters supported EPA’s consideration of downstream WQS in Oregon when establishing the criteria upstream, while others expressed 55 EPA’s PO 00000 2000 Methodology, pages 2–6. Frm 00027 Fmt 4700 Sfmt 4700 85427 concern that EPA was suggesting that Washington’s upstream criteria must be identical to Oregon’s downstream criteria and in doing so, acting inconsistently with its 2014 Frequently Asked Questions document on downstream protection.56 For detailed responses to these comments, see EPA’s Response to Comment document in the docket for this rule. c. Relative Source Contribution EPA recommends using a RSC for non-carcinogens and nonlinear carcinogens to account for sources of exposure other than drinking water and consumption of inland and nearshore fish and shellfish (see section II.C.d). In 2015, after evaluating information on chemical uses, properties, occurrences, releases to the environment and regulatory restrictions, EPA developed chemical-specific RSCs for noncarcinogens and nonlinear carcinogens ranging from 0.2 (20 percent) to 0.8 (80 percent) following the Exposure Decision Tree approach described in EPA’s 2000 Methodology.57 58 EPA proposed to use these same RSCs to derive human health criteria for Washington, and where EPA did not update the nationally recommended criteria for certain pollutants in 2015, EPA proposed to use a RSC of 0.2 to derive human health criteria for those pollutants in Washington to ensure protectiveness. Several commenters supported EPA’s use of RSCs to account for other sources of pollutant exposure. Several others disagreed, arguing that water quality criteria under the CWA cannot control or consider sources of exposure other than from drinking water and eating fish and shellfish, so human health criteria should not account for these sources. Many of the commenters, in addition to criticizing the concept of RSCs as overly-conservative, argued that EPA was double-counting exposure to anadromous fish (which EPA considers marine in the national dataset) by both including them in the FCR and using the pollutant-specific RSCs that EPA pairs with an inland and nearshore-only 56 https://nepis.epa.gov/Exe/ZyPDF.cgi/ P100LIJF.PDF?Dockey=P100LIJF.PDF. 57 USEPA. 2000. Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA–822– B–00–004. https://www.epa.gov/wqc/humanhealth-water-quality-criteria. 58 Final Updated Ambient Water Quality Criteria for the Protection of Human Health, (80 FR 36986, June 29, 2015). See also: USEPA. 2015. Final 2015 Updated National Recommended Human Health Criteria. U.S. Environmental Protection Agency, Office of Water, Washington, DC https:// www.epa.gov/wqc/human-health-water-qualitycriteria. E:\FR\FM\28NOR1.SGM 28NOR1 85428 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES FCR in its 304(a) national recommended human health criteria. Commenters argued that this is inconsistent with EPA’s guidance, which recommends that states adjust the RSC to reflect a greater proportion of the RfD being attributed to water, fish and shellfish intake in instances where the FCR includes freshwater, estuarine and all marine fish consumption.59 For detailed responses to the comments, see EPA’s Response to Comment document in the docket for this rule. Additionally, after further evaluation of the proposed revised human health criteria for antimony, EPA determined that the existing 304(a) national recommended criteria for antimony (last updated in 2002) use a pollutantspecific RSC of 0.4. EPA intended to apply a 0.2 RSC as a protective approach only where pollutant-specific RSCs were not already developed, which is not the case for antimony.60 While the selected FCR of 175 g/day does not include all marine fish (e.g., it does not include consumption of species such as swordfish, tuna, etc.), EPA acknowledges that the criteria as proposed may have double-counted potential exposure to some pollutants in certain marine fish that are anadromous (e.g., salmon). Therefore, EPA reviewed the RSCs in the proposed rule in light of EPA’s guidance, which includes both the Exposure Decision Tree and associated discussion in EPA’s 2000 Methodology, as well as EPA’s recommendation to adjust the RSC when the FCR includes freshwater, estuarine, and all marine fish consumption. Arguably, EPA’s guidance does not consider this exact scenario where the selected FCR includes some, but not all, species that EPA classifies as marine in the national NHANES dataset (and excludes some species that EPA classifies as nearshore in the national NHANES dataset, i.e., shellfish). One way to adjust the RSC values to account for inclusion of marine fish in the FCR is to examine the ratio of the national data characterizing all fish consumption rates versus inland and nearshore-only fish consumption rates derived from the NHANES dataset, and apply this ratio to the proportion of the RfD reserved for inland and nearshore 59 USEPA. January 2013. Human Health Ambient Water Quality Criteria and Fish Consumption Rates: Frequently Asked Questions. https://www.epa.gov/ wqc/human-health-ambient-water-quality-criteriaand-fish-consumption-rates-frequently-asked. 60 https://nepis.epa.gov/Exe/ ZyPDF.cgi?Dockey=20003IEI.txt See also: National Primary Drinking Water Regulations-Synthetic Organic Chemicals and Inorganic Chemicals; National Primary Drinking Water Regulations Implementation, 57 FR 31776, July 17, 1992. VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 fish consumption in the RSC. This approach assumes that the pollutant concentrations in anadromous fish are the same as the pollutant concentrations in inland and nearshore fish, which is the same assumption inherent in including multiple fish categories in the FCR for criteria calculation. This approach further assumes that the ratio of all fish to inland and nearshore fish from NHANES data approximates the ratio of inland, nearshore, and anadromous fish to just inland and nearshore fish from CRITFC data. At the 90th percentile rate of consumption, the national adult consumption rate from NHANES data for all fish is 53 g/day and 22 g/day for inland and nearshoreonly fish, or a ratio of 2.4. Applying this to a RSC of 0.2 yields 0.48, or 0.5 rounding to a single decimal place. Because the selected FCR includes some but not all marine species, EPA decided to use this approach to adjust the RSC values. However, EPA only adjusted RSC values to 0.5 for criteria calculations previously using a RSC between 0.2 and 0.5. There are important considerations in assigning a RSC, such as the total number of potential exposure routes from sources other than fish consumption, which compels caution in using this approach in all cases. As such, EPA decided to retain RSC values of 0.5 and above, recognizing the compelling need to account for the other potential exposure sources, including marine fish not accounted for in the FCR of 175 g/day, consistent with the logic and procedures used in establishing the national 304(a) criteria recommendations. The Exposure Decision Tree in EPA’s 2000 Methodology only recommends using a RSC above 0.5 when there are no significant known or potential uses/ sources other than the source of concern (Box 7, Figure 4–1 in EPA’s 2000 Methodology) or there are sufficient data available on each source to characterize the exposure to those sources (Box 8C, Figure 4–1). Neither of these conditions are met for most of the pollutants in the final rule for Washington. EPA is not adjusting the RSCs for pollutants that already have national recommended RSCs greater than or equal to 0.5 (2– Chloronaphthalene (0.8), Endrin (0.8), gamma-BHC/Lindane (0.5), and methylmercury (2.7 × 10¥5 subtracted from the RfD, which equates to a RSC of approximately 0.73). See Table 1, column B2 for a list of EPA’s final RSCs by pollutant. PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 d. Body Weight EPA calculates final human health criteria for Washington using a body weight of 80 kg, which represents the average weight of a U.S. adult and is consistent with EPA’s 2015 updated national default body weight (see section II.C.c).61 Local tribal survey data relevant to Washington are also consistent with EPA’s national adult body weight of 80 kg.62 Most commenters were silent on EPA’s proposal to use a body weight of 80 kg to calculate human health criteria for Washington. A few commenters were concerned that 80 kg would not ensure adequate protection of women and children, and may not be representative of all residents in Washington based on limited local or regional data on body weight specific to Washington residents. EPA understands these concerns, but decided that the survey on which EPA’s national default of 80 kg is based provides the most comprehensive dataset to establish a body weight value for deriving statewide human health criteria for Washington, and is consistent with the local tribal survey data mentioned above. The data cited by commenters do not provide sufficient evidence to come up with an alternative statewide body weight input parameter since the studies cited are limited in scope and pertain to specific subpopulations. For detailed responses to the comments, see EPA’s Response to Comment document in the docket for this rule. e. Drinking Water Intake EPA calculates final human health criteria for Washington using a drinking water intake rate of 2.4 L/day, consistent with EPA’s 2015 updated national default drinking water intake rate (see section II.C.c).63 Most commenters were 61 Final Updated Ambient Water Quality Criteria for the Protection of Human Health, (80 FR 36986, June 29, 2015). See also: USEPA. 2015. Final 2015 Updated National Recommended Human Health Criteria. U.S. Environmental Protection Agency, Office of Water, Washington, DC https:// www.epa.gov/wqc/human-health-water-qualitycriteria. 62 USEPA Region 10. August 2007. Framework for Selecting and Using Tribal Fish and Shellfish Consumption Rates for Risk-Based Decision Making at CERCLA and RCRA Cleanup Sites in Puget Sound and the Strait of Georgia. Appendix B. https://yosemite.epa.gov/r10/CLEANUP.NSF/ 7780249be8f251538825650f0070bd8b/ e12918970debc8e488256da6005c428e/$FILE/ Tribal%20Shellfish%20Framework.pdf. 63 Final Updated Ambient Water Quality Criteria for the Protection of Human Health, (80 FR 36986, June 29, 2015). See also: USEPA. 2015. Final 2015 Updated National Recommended Human Health Criteria. U.S. Environmental Protection Agency, Office of Water, Washington, DC https:// www.epa.gov/wqc/human-health-water-qualitycriteria. E:\FR\FM\28NOR1.SGM 28NOR1 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations silent on or agreed with EPA’s proposal to use a drinking water intake rate of 2.4 L/day to calculate human health criteria for Washington. However, two commenters stated this input was unnecessary in human health criteria derivation. Since at least the 1980s, EPA has included the drinking water exposure pathway in the development of human health criteria in order to protect water bodies with a drinking water designated use. EPA also provides the option of using organism-only human health criteria for water bodies where there is no drinking water use. One commenter stated that 2.4 L/day was an underestimate, and expressed concern that this value is not protective of tribal members who consume more water. EPA determined that it is appropriate to use its 2015 final national default drinking water intake rate, since it was adjusted pursuant to public comments after EPA issued the draft national default rate of 3 L/day in 2014. EPA acknowledges the concerns about members of the target general population who may consume larger amounts of water, but EPA does not have data (and did not receive any during the public comment period) with which to calculate a Washingtonspecific drinking water intake rate. For detailed responses to the comments, see EPA’s Response to Comment document in the docket for this rule. g. Pollutant-Specific Bioaccumulation Factors As part of EPA’s 2015 updates to its 304(a) recommended human health criteria, EPA conducted a systematic search of eight peer-reviewed, publicly available sources to obtain the most current toxicity values for each pollutant (RfDs for non-carcinogenic effects and CSFs for carcinogenic effects).64 EPA calculates final human health criteria for Washington using the same toxicity values that EPA used in its 2015 304(a) criteria updates, to ensure that the resulting criteria are based on a sound scientific rationale. Where EPA did not update criteria for certain pollutants in 2015 and those pollutants are included in this final rule, EPA uses the toxicity values that the Agency used the last time it updated its 304(a) criteria for those pollutants as the best available scientific information. See Table 1, columns B1 and B3 for a For the 2015 national 304(a) human health criteria update, EPA estimated chemical-specific BAFs using a framework for deriving national BAFs described in EPA’s 2000 Methodology.65 Because the surveyed population upon which the 175 g/day FCR is based consumed almost exclusively trophic level four fish (i.e., predator fish species), EPA uses the trophic level four BAF from the 2015 304(a) human health criteria updates in conjunction with the 175 g/day FCR, in order to derive protective criteria.66 Where in 2015, EPA estimated BAFs from laboratorymeasured BCFs and therefore derived a single pollutant-specific BAF for all trophic levels, EPA uses those single BAFs from the 2015 304(a) human health criteria updates. Where EPA’s existing 304(a) recommended human health criteria for certain pollutants still incorporate a BCF, and those pollutants are included in this final rule, EPA uses those BCFs as the best available scientific information. See Table 1, columns B4 and B5 for a list of EPA’s 64 Final Updated Ambient Water Quality Criteria for the Protection of Human Health, (80 FR 36986, June 29, 2015). See also: USEPA. 2015. Final 2015 Updated National Recommended Human Health Criteria. U.S. Environmental Protection Agency, Office of Water, Washington, DC https:// www.epa.gov/wqc/human-health-water-qualitycriteria. 65 USEPA. 2000. Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health. U.S. Environmental Protection Agency, Office of Water, Washington, DC EPA–822– f. Pollutant-Specific Reference Doses and Cancer Slope Factors mstockstill on DSK3G9T082PROD with RULES list of EPA’s final toxicity factors by pollutant. In general, commenters were supportive of EPA using the latest and most scientifically defensible toxicity values to derive human health criteria for Washington. Some commenters expressed concern that where EPA did not update its 304(a) national recommended human health criteria for particular pollutants in 2015, the toxicity values from the existing 304(a) criteria for those pollutants were no longer valid. In particular, those commenters expressed concern about the CSFs for arsenic and PCBs, and the RfD for methylmercury, and argued that EPA should not revise Washington’s criteria for those pollutants until toxicity factors are updated in the future. Unlike the situation with the toxicity factors for arsenic, dioxin and thallium (see section III.A), there is not sufficient scientific uncertainty surrounding the CSF for PCBs or the RfD for methylmercury to warrant delaying revision to Washington’s human health criteria for these pollutants. For detailed responses to the comments, see EPA’s Response to Comment document in the docket for this rule. VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 85429 final bioaccumulation factors by pollutant. Many commenters supported EPA’s choice to use the latest and most scientifically defensible BAFs to derive human health criteria for Washington, and to use BCFs only when BAFs were not available for a given pollutant. Other commenters asserted that BCFs are no less scientifically defensible than BAFs, and that EPA did not provide sufficient information regarding how it developed BAFs in 2015 for commenters to fully evaluate EPA’s proposed approach. EPA’s 2000 Methodology recommends use of BAFs that account for uptake of a contaminant from all sources by fish and shellfish, rather than BCFs that only account for uptake from the water column. EPA’s 2015 national recommended BAFs are based on peerreviewed, publicly available data and were developed consistent with EPA’s 2000 Methodology and its supporting documents. EPA provided the basis for its 2015 BAFs in individual pollutantspecific criteria documents. The final human health criteria for Washington are consistent with EPA’s 2000 Methodology, which makes clear that BAFs are a more scientifically defensible representation of bioaccumulation than BCFs. For detailed responses to the comments, see EPA’s Response to Comment document in the docket for this rule. D. Final Human Health Criteria for Washington EPA finalizes 144 human health criteria for 74 different pollutants (72 organism-only criteria and 72 waterplus-organism criteria) to protect the applicable designated uses of Washington’s waters (see Table 1). The water-plus-organism criteria in column C1 and the methylmercury criterion in column C2 of Table 1 are the applicable criteria for any waters that include the Domestic Water (domestic water supply) use defined in Washington’s WQS (WAC 173–201A–600). The organismonly criteria in column C2 of Table 1 apply to waters that do not include the Domestic Water (domestic water supply) use and that Washington defines at WAC 173–201A–600 and 173–201A– 610 as the following: Fresh waters— Harvesting (fish harvesting), and Recreational Uses; Marine waters— Shellfish Harvesting (shellfish—clam, oyster, and mussel—harvesting), Harvesting (salmonid and other fish B–00–004. https://www.epa.gov/wqc/humanhealth-water-quality-criteria. 66 Fish Consumption Survey of the Umatilla, Nez Perce, Yakama, and Warm Springs Tribes of the Columbia River Basin (Columbia River Inter-Tribal Fish Commission (CRITFC), 1994) E:\FR\FM\28NOR1.SGM 28NOR1 85430 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations harvesting, and crustacean and other shellfish—crabs, shrimp, scallops, etc.— harvesting), and Recreational Uses. TABLE 1—HUMAN HEALTH CRITERIA FOR WASHINGTON A B C mstockstill on DSK3G9T082PROD with RULES CAS No. 1. 1,1,1-4Trichloroethane .................... 2. 1,1,2,2-Tetrachloroethane ............... 3. 1,1,2-Trichloroethane ...................... 4. 1,1-Dichloroethylene ....................... 5. 1,2,4-Trichlorobenzene ................... 6. 1,2-Dichlorobenzene ....................... 7. 1,2-Dichloroethane .......................... 8. 1,2-Dichloropropane ........................ 9. 1,2-Diphenylhydrazine .................... 10. 1,2-Trans-Dichloroethylene ........... 11. 1,3-Dichlorobenzene ..................... 12. 1,3-Dichloropropene ...................... 13. 1,4-Dichlorobenzene ..................... 14. 2,3,7,8–TCDD (Dioxin) ** .............. 15. 2,4,6-Trichlorophenol .................... 16. 2,4-Dichlorophenol ........................ 17. 2,4-Dimethylphenol ....................... 18. 2,4-Dinitrophenol ........................... 19. 2,4-Dinitrotoluene .......................... 20. 2-Chloronaphthalene ..................... 21. 2-Chlorophenol .............................. 22. 2-Methyl-4,6-Dinitrophenol ............ 23. 3,3′-Dichlorobenzidine .................. 24. 3-Methyl-4-Chlorophenol ............... 25. 4,4′-DDD ....................................... 26. 4,4′-DDE ....................................... 27. 4,4′-DDT ........................................ 28. Acenaphthene ............................... 29. Acrolein ......................................... 30. Acrylonitrile .................................... 31. Aldrin ............................................. 32. alpha-BHC ..................................... 33. alpha-Endosulfan .......................... 34. Anthracene .................................... 35. Antimony ....................................... 36. Arsenic ** ....................................... 37. Asbestos ....................................... 38. Benzene ........................................ 39. Benzidine ...................................... 40. Benzo(a) Anthracene .................... 41. Benzo(a) Pyrene ........................... 42. Benzo(b) Fluoranthene ................. 43. Benzo(k) Fluoranthene ................. 44. beta-BHC ...................................... 45. beta-Endosulfan ............................ 46. Bis(2-Chloroethyl) Ether ................ 47. Bis(2-Chloro-1-Methylethyl) Ether * 48. Bis(2-Ethylhexyl) Phthalate ........... 49. Bromoform .................................... 50. Butylbenzyl Phthalate ................... 51. Carbon Tetrachloride .................... 52. Chlordane ...................................... 53. Chlorobenzene .............................. 54. Chlorodibromomethane ................. 55. Chloroform .................................... 56. Chrysene ....................................... 57. Copper .......................................... 58. Cyanide ......................................... 59. Dibenzo(a,h) Anthracene .............. 60. Dichlorobromomethane ................. 61. Dieldrin .......................................... 62. Diethyl Phthalate ........................... 63. Dimethyl Phthalate ........................ 64. Di-n-Butyl Phthalate ...................... 65. Endosulfan Sulfate ........................ 66. Endrin ............................................ 67. Endrin Aldehyde ............................ 68. Ethylbenzene ................................ 69. Fluoranthene ................................. 70. Fluorene ........................................ 71. gamma-BHC; Lindane .................. VerDate Sep<11>2014 16:28 Nov 25, 2016 71556 79345 79005 75354 120821 95501 107062 78875 122667 156605 541731 542756 106467 1746016 88062 120832 105679 51285 121142 91587 95578 534521 91941 59507 72548 72559 50293 83329 107028 107131 309002 319846 959988 120127 7440360 7440382 1332214 71432 92875 56553 50328 205992 207089 319857 33213659 111444 108601 117817 75252 85687 56235 57749 108907 124481 67663 218019 7440508 57125 53703 75274 60571 84662 131113 84742 1031078 72208 7421934 100414 206440 86737 58899 Jkt 241001 Cancer slope factor, CSF (per mg/ kg·d) Relative source contribution, RSC (-) Reference dose, RfD (mg/kg·d) Bio-accumulation factor (L/kg tissue) Bio-concentration factor (L/kg tissue) Water & organisms (μg/L) Organisms only (μg/L) (B1) Chemical (B2) (B3) (B4) (B5) (C1) (C2) 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.80 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.80 0.50 0.50 0.50 0.50 2 .................... .................... 0.05 .................... 0.3 .................... .................... .................... 0.02 0.002 .................... 0.07 .................... .................... 0.003 .................... 0.002 .................... 0.08 .................... 0.0003 .................... .................... .................... .................... .................... 0.06 .................... .................... .................... .................... 0.006 0.3 0.0004 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... 0.04 .................... .................... .................... .................... .................... 0.02 .................... 0.01 .................... .................... 0.0006 .................... .................... .................... 0.8 10 0.1 0.006 0.0003 .................... 0.022 0.04 0.04 0.0047 10 8.4 8.9 2.6 430 82 1.9 ............................ 27 4.7 190 3.0 84 ............................ ............................ 48 ............................ 4.4 ............................ 240 ............................ 10 ............................ ............................ 240,000 3,100,000 1,100,000 510 ............................ ............................ 650,000 1,500 200 610 ............................ ............................ ............................ ............................ ............................ 3,900 3,900 3,900 3,900 180 ............................ ............................ 10 710 8.5 19,000 ............................ 60,000 22 5.3 3.8 3,900 ............................ ............................ 3,900 4.8 410,000 920 4,000 2,900 140 46,000 ............................ 160 1,500 710 2,500 ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ 5,000 ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ 1 44 ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ 1 ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ 20,000 0.1 0.35 700 0.036 700 8.9 .................. 0.01 200 2 0.22 200 1.3E–08 .................. 10 .................. 30 .................. 100 .................. 3 .................. .................. 7.9E–06 8.8E–07 1.2E–06 30 .................. .................. 4.1E–08 4.8E–05 6 100 6 a 0.018 .................. .................. .................. 0.00016 1.6E–05 0.00016 0.0016 0.0013 .................. .................. 400 0.045 4.6 0.013 .................. 2.2E–05 100 0.60 100 0.016 .................. 9 1.6E–05 0.73 7.0E–08 200 600 8 9 0.002 .................. 29 6 10 0.43 50,000 0.3 0.90 4,000 0.037 800 73 ........................ 0.02 1,000 2 1.2 200 1.4E–08 ........................ 10 ........................ 100 ........................ 100 ........................ 7 ........................ ........................ 7.9E–06 8.8E–07 1.2E–06 30 ........................ ........................ 4.1E–08 4.8E–05 7 100 90 a 0.14 ........................ ........................ ........................ 0.00016 1.6E–05 0.00016 0.0016 0.0014 ........................ ........................ 900 0.046 12 0.013 ........................ 2.2E–05 200 2.2 600 0.016 ........................ 100 1.6E–05 2.8 7.0E–08 200 600 8 ........................ 0.002 ........................ 31 6 10 0.43 Fmt 4700 Sfmt 4700 .................... 0.2 0.057 .................... 0.029 .................... 0.0033 .................... 0.8 .................... .................... 0.122 .................... 156,000 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... 0.24 0.167 0.34 .................... .................... .................... 17 6.3 .................... .................... .................... 1.75 .................... .................... .................... 0.73 7.3 0.73 0.073 1.8 .................... .................... .................... 0.014 0.0045 0.0019 .................... 0.35 .................... 0.04 .................... 0.0073 .................... .................... 7.3 0.034 16 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... PO 00000 Frm 00030 E:\FR\FM\28NOR1.SGM 28NOR1 85431 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations TABLE 1—HUMAN HEALTH CRITERIA FOR WASHINGTON—Continued A B C 72. 73. 74. 75. 76. 77. 78. 79. 80. 81. 82. 83. 84. 85. 86. 87. 88. 89. 90. 91. 92. 93. 94. 95. 96. 97. 98. 99. CAS No. Heptachlor ..................................... Heptachlor Epoxide ....................... Hexachlorobenzene ...................... Hexachlorobutadiene .................... Hexachlorocyclopentadiene .......... Hexachloroethane ......................... Indeno(1,2,3-cd) Pyrene ............... Isophorone .................................... Methyl Bromide ............................. Methylene Chloride ....................... Methylmercury ............................... Nickel ............................................ Nitrobenzene ................................. N-Nitrosodimethylamine ................ N-Nitrosodi-n-Propylamine ............ N-Nitrosodiphenylamine ................ Pentachlorophenol (PCP) ............. Phenol ........................................... Polychlorinated Biphenyls (PCBs) Pyrene ........................................... Selenium ....................................... Tetrachloroethylene ...................... Thallium ** ..................................... Toluene ......................................... Toxaphene .................................... Trichloroethylene ........................... Vinyl Chloride ................................ Zinc ............................................... 76448 1024573 118741 87683 77474 67721 193395 78591 74839 75092 22967926 7440020 98953 62759 621647 86306 87865 108952 ................ 129000 7782492 127184 7440280 108883 8001352 79016 75014 7440666 Relative source contribution, RSC (-) Reference dose, RfD (mg/kg·d) Bio-accumulation factor (L/kg tissue) Bio-concentration factor (L/kg tissue) Water & organisms (μg/L) Organisms only (μg/L) (B1) Chemical Cancer slope factor, CSF (per mg/ kg·d) (B2) (B3) (B4) (B5) (C1) (C2) .................... .................... .................... .................... 0.006 .................... .................... .................... 0.02 .................... 0.0001 0.02 0.002 .................... .................... .................... .................... 0.6 .................... 0.03 0.005 .................... 0.000068 0.0097 .................... .................... .................... 0.3 330,000 35,000 90,000 1,100 1,300 600 3,900 ............................ 1.4 1.6 ............................ ............................ 3.1 ............................ ............................ ............................ 520 1.9 ............................ 860 ............................ 76 ............................ 17 ............................ 13 1.7 ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ 47 ............................ ............................ ............................ ............................ ............................ ............................ 31,200 ............................ 4.8 ............................ 116 ............................ ............................ ............................ ............................ 47 3.4E–07 2.4E–06 5.0E–06 0.01 1 0.02 0.00016 .................. 300 10 .................. 80 30 .................. .................. .................. 0.002 9,000 c 7E–06 8 60 2.4 1.7 72 .................. 0.3 .................. 1,000 3.4E–07 2.4E–06 5.0E–06 0.01 1 0.02 0.00016 ........................ ........................ 100 b 0.03 (mg/kg) 100 100 ........................ ........................ ........................ 0.002 70,000 c 7E–06 8 200 2.9 6.3 130 ........................ 0.7 0.18 1,000 4.1 5.5 1.02 0.04 .................... 0.04 0.73 .................... .................... 0.002 .................... .................... .................... .................... .................... .................... 0.4 .................... 2 .................... .................... 0.0021 .................... .................... .................... 0.05 1.5 .................... 0.50 0.50 2.7E–05 0.50 0.50 0.50 0.50 0.50 0.50 0.50 a This criterion refers to the inorganic form of arsenic only. criterion is expressed as the fish tissue concentration of methylmercury (mg methylmercury/kg fish). See Water Quality Criterion for the Protection of Human Health: Methylmercury (EPA–823–R–01–001, January 3, 2001) for how this value is calculated using the criterion equation in EPA’s 2000 Human Health Methodology rearranged to solve for a protective concentration in fish tissue rather than in water. c This criterion applies to total PCBs (e.g., the sum of all congener or isomer or homolog or Aroclor analyses). * Bis(2-Chloro-1-Methylethyl) Ether was previously listed as Bis(2-Chloroisopropyl) Ether. ** These criteria were promulgated for Washington in the National Toxics Rule at 40 CFR 131.36, and are moved into 40 CFR 131.45 to have one comprehensive human health criteria rule for Washington. b This mstockstill on DSK3G9T082PROD with RULES E. Applicability of Criteria These new and revised human health criteria apply for CWA purposes in addition to any existing criteria already applicable to Washington’s waters, including the state’s narrative toxics criteria statement at WAC 173–201A– 260(2)(a), and those human health criteria that Washington submitted on August 1, 2016, and EPA approved concurrent with this final rule. EPA replicates in 40 CFR 131.45 the same general rules of applicability for human health criteria as in 40 CFR 131.36(c), with one exception. For waters suitable for the establishment of low flow return frequencies (i.e., streams and rivers), this final rule provides that Washington must not use a low flow value below which numeric standards can be exceeded that is less stringent than the harmonic mean flow (a long-term mean flow value calculated by dividing the number of daily flows analyzed by the sum of the reciprocals of those daily flows), so that the criteria are implemented to be protective of the applicable designated use. Per the VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 Revisions to the Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (65 FR 66444, November 3, 2000), EPA now recommends harmonic mean flow be used to implement human health criteria for both carcinogens and noncarcinogens.67 EPA received one comment on this provision, asking for clarification on whether this is consistent with Washington’s current permitting approach of using the 30Q5 flow for non-carcinogens.68 In response, Washington’s use of low flow statistics more stringent than the harmonic mean flow is consistent with EPA’s final rule. Under the CWA, Congress gave states primary responsibility for developing and adopting WQS for their navigable waters (CWA section 303(a)-(c)). 67 See also USEPA. 2014. Water Quality Standards Handbook—Chapter 5: General Policies. U.S. Environmental Protection Agency. Office of Water. Washington, DC EPA–820–B–14–004. https://www.epa.gov/wqs-tech/water-qualitystandards-handbook. 68 The 30Q5 flow is the lowest 30-day average flow event expected to occur once every five years, on average (determined hydrologically). PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 Although EPA revises and establishes new human health criteria for Washington in this final rule, Washington continues to have the option to adopt and submit to EPA human health criteria for the pollutants in this final rule, consistent with CWA section 303(c) and EPA’s implementing regulations at 40 CFR part 131. In its September 14, 2015 proposed rule, EPA proposed that if Washington adopted and submitted human health criteria, and EPA approved those criteria before finalizing its federal rule, EPA would not proceed with finalizing those criteria and Washington’s approved criteria would be solely applicable for CWA purposes. EPA did not receive any comments opposing this provision, thus EPA is proceeding with such an approach. In this final rule, EPA is withdrawing Washington from the NTR at 40 CFR 131.36, and, with the exception of criteria for which EPA has approved Washington’s criteria, EPA is incorporating the Washington-specific criteria in this rule (as well as the existing NTR criteria for arsenic, dioxin E:\FR\FM\28NOR1.SGM 28NOR1 85432 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES and thallium) into 40 CFR 131.45 so there is a single comprehensive set of federally promulgated criteria for Washington. Therefore, the CWAeffective numeric human health criteria in Washington consist of the federally promulgated criteria at 40 CFR 131.45 and those criteria that EPA approved at WAC 173–201A–240 in Washington’s August 1, 2016 submittal. Additionally, in its September 14, 2015 proposed rule, EPA proposed that if Washington adopted and submitted human health criteria after EPA finalized its rule, once EPA approved Washington’s WQS, the pollutantspecific or site-specific EPA-approved criteria in Washington’s WQS would become the solely effective criteria for CWA purposes and EPA’s promulgated criteria for those pollutants or for that site would no longer apply. A few commenters supported this provision, where Washington’s criteria for specific pollutants or sites become the only CWA-effective criteria upon EPA’s approval, without any delay caused by EPA’s withdrawal of the corresponding federal criteria. A few other commenters did not support this provision, and asked that EPA either delete the provision, or make clear that criteria adopted by the state would have to be at least as stringent as the federal criteria for EPA to approve and make the state criteria effective for CWA purposes. Upon further consideration of comments received on its proposed rule, EPA decided not to finalize this provision. Pursuant to 40 CFR 131.21(c), EPA’s federally promulgated WQS are and will be applicable for purposes of the CWA until EPA withdraws those federally promulgated WQS. EPA would undertake such a rulemaking to withdraw the federal criteria if and when Washington adopts and EPA approves corresponding criteria that meet the requirements of section 303(c) of the CWA and EPA’s implementing regulations at 40 CFR part 131. F. Alternative Regulatory Approaches and Implementation Mechanisms Washington has considerable discretion to implement these revised and new federal human health criteria through various water quality control programs including the NPDES program, which limits discharges to waters except in compliance with a NPDES permit. EPA’s regulations at 40 CFR 131.14 authorize states and authorized tribes to adopt WQS variances to provide time to achieve the applicable WQS. 40 CFR part 131 defines WQS variances at 131.3(o) as time-limited designated uses and supporting criteria for a specific VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 pollutant(s) or water quality parameter(s) that reflect the highest attainable conditions during the term of the WQS variances. WQS variances adopted in accordance with 40 CFR part 131 allow states and authorized tribes to address water quality challenges in a transparent and predictable way. Variances help states and authorized tribes focus on making incremental progress in improving water quality, rather than pursuing a downgrade of the underlying water quality goals through a designated use change, when the designated use is not attainable throughout the term of the variance due to one of the factors listed in 40 CFR 131.14. EPA’s regulations at 40 CFR 122.47 provide the requirements when states and authorized tribes wish to include permit compliance schedules in their NPDES permits if dischargers need additional time to meet their water quality-based limits based on the applicable WQS. EPA’s updated regulations at 40 CFR 131.15 require any state or authorized tribe wishing to use permit compliance schedules to also include provisions authorizing the use of permit compliance schedules after appropriate public involvement to ensure that a decision to allow permit compliance schedules derives from and complies with the applicable WQS. (80 FR 51022, August 21, 2015). 40 CFR 131.10 specifies how states and authorized tribes establish, modify or remove designated uses for their waters. 40 CFR 131.11 specifies the requirements for establishing criteria to protect designated uses, including criteria modified to reflect site-specific conditions. In the context of this rulemaking, a site-specific criterion (SSC) is an alternative value to the federal human health criteria that could be applied on a watershed, area-wide, or waterbody-specific basis that meets the regulatory test of protecting the designated use, being scientifically defensible, and ensuring the protection and maintenance of downstream WQS. A SSC may be more or less stringent than the otherwise applicable federal criterion. A SSC may be appropriate when further scientific data and analyses can bring added precision to express the concentration of a particular pollutant that protects the human health-related designated use in a particular waterbody. A few commenters supported EPA’s acknowledgement of the flexibilities that Washington has available when implementing the final criteria in this rule, while others commented that these tools allow Washington to delay or avoid implementing the criteria. EPA did not propose to change, nor does this PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 final rule change, any of the flexibilities already afforded to Washington by EPA’s regulations to modify or remove designated uses, adopt variances, issue compliance schedules, or establish sitespecific criteria. These implementation tools are important for making incremental progress and allowing the time for adaptive management when designated uses and associated criteria are difficult to attain. Washington may continue to use any of these regulatory flexibilities when implementing the final federal human health criteria. a. Designating Uses EPA’s final human health criteria apply to waters that Washington has designated for the following: Fresh waters—Harvesting (fish harvesting), Domestic Water (domestic water supply), and Recreational Uses; Marine waters—Shellfish Harvesting (shellfish—clam, oyster, and mussel— harvesting), Harvesting (salmonid and other fish harvesting, and crustacean and other shellfish—crabs, shrimp, scallops, etc.—harvesting), and Recreational Uses (see WAC 173–201A– 600 and WAC 173–201A–610). If Washington removes the Domestic Water use but retains any of the other above designated uses for any particular waterbody affected by this final rule, and EPA finds that removal to be consistent with CWA section 303(c) and EPA’s implementing regulations at 40 CFR part 131, then the federal organismonly criteria will apply in place of the federal water-plus-organism criteria. If Washington removes designated uses such that none of the above uses apply to any particular waterbody affected by this final rule and adopts the highest attainable use, as defined by 40 CFR 131.3(m), consistent with 40 CFR 131.10(g), and EPA finds that removal to be consistent with CWA section 303(c) and EPA’s implementing regulations at 40 CFR part 131, then the federal human health criteria will no longer apply to that waterbody. Instead, any criteria associated with the newly designated highest attainable use would apply to that waterbody. b. Variances and Compliance Schedules EPA’s final human health criteria apply to use designations that Washington has already established. Concurrent with this final rule, EPA approved revisions to Washington’s variance and compliance schedule authorizing provisions. Washington may use its EPA-approved variance procedures (see WAC 173–201A–420) to establish time-limited designated uses and criteria to apply for the purposes specified in 40 CFR 131.14 as it pertains E:\FR\FM\28NOR1.SGM 28NOR1 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations to federal criteria when adopting such variances. Washington has sufficient authority to use variances when implementing the human health criteria as long as such variances are adopted consistent with 40 CFR 131.14, and submitted to EPA for review under CWA section 303(c). Similarly, Washington may use its EPA-approved regulation authorizing the use of permit compliance schedules (see WAC 173– 201A–510(4)), consistent with 40 CFR 131.15, to grant compliance schedules, as appropriate, for WQBELs based on the federal criteria. These state regulations are not affected by this final rule. c. Site-Specific Criteria As discussed in section III.E, if Washington adopts and EPA approves site-specific criteria that fully meet the requirements of section 303(c) of the CWA and EPA’s implementing regulations at 40 CFR part 131, EPA will undertake a rulemaking to withdraw the corresponding federal criteria. IV. Economic Analysis Under the CWA, water quality criteria are set on the basis of the latest scientific knowledge. EPA is not required under the CWA nor obligated under Executive Orders 12866 and 13563 to conduct an economic analysis of the criteria. Costs cannot be considered in establishing water quality criteria as part of WQS. Nonetheless, EPA conducted a cost analysis for the criteria in this final rule for the purpose of transparency and presents this information reflecting the potential economic effects of the rule. These WQS may serve as a basis for development of NPDES permit limits. Washington has NPDES permitting authority, and retains considerable discretion in implementing standards. EPA evaluated the potential costs to NPDES dischargers associated with state implementation of EPA’s final criteria. This analysis is documented in Final Economic Analysis for the Revision of Certain Federal Water Quality Criteria Applicable to Washington, which can be found in the record for this rulemaking. Any NPDES-permitted facility that discharges pollutants for which the revised human health criteria are more stringent than the applicable aquatic life criteria (or for which human health criteria are the only applicable criteria) could potentially incur compliance costs. The types of affected facilities could include industrial facilities and POTWs discharging wastewater to surface waters (i.e., point sources). EPA did not attribute compliance with water quality-based effluent limitations (WQBELs) reflective of existing federal human health criteria applicable to Washington (hereafter referred to as ‘‘baseline criteria’’) to the final rule. Once in compliance with WQBELs reflective of baseline criteria, EPA expects that dischargers will continue to use the same types of controls to come 85433 into compliance with the revised criteria; EPA did not fully evaluate the potential for costs to nonpoint sources,69 such as agricultural runoff, that could be incurred under a TMDL for this analysis, but did analyze the administrative costs to the state of preparing TMDLs for potentially incrementally impaired waters. Actual costs of implementation of TMDLs is beyond the scope of this analysis. A. Identifying Affected Entities EPA identified 406 point source facilities that could ultimately be affected by this final rule. Of these potentially affected facilities, 73 are major dischargers and 333 are minor dischargers. EPA did not include general permit facilities in its analysis because data for such facilities are limited, and flows are usually negligible. Of the potentially affected facilities, EPA evaluated a sample of 17 major facilities. Minor facilities are unlikely to incur costs as a result of implementation of the rule, because minor facilities are typically those that do not discharge toxics in toxic amounts and discharge less than 1 million gallons per day (mgd). Although lower human health criteria could potentially change this categorization, EPA did not have effluent data on toxic pollutants to evaluate minor facilities for this analysis. Table 2 summarizes these potentially affected facilities by type and category. TABLE 2—POTENTIALLY AFFECTED FACILITIES Category Minor Major All Municipal ...................................................................................................................................... Industrial ...................................................................................................................................... 184 149 48 25 232 174 Total ...................................................................................................................................... 333 73 406 mstockstill on DSK3G9T082PROD with RULES B. Method for Estimating Costs EPA evaluated the two major municipal facilities with design flows greater than 100 mgd and a large industrial refinery, to attempt to capture the facilities with the potential for the largest costs. For the remaining major facilities, EPA evaluated a random sample of facilities to represent discharger type and category. For all sample facilities, EPA evaluated existing baseline permit conditions, reasonable potential to exceed human health criteria based on the final rule, and potential to exceed projected effluent limitations based on the last three years of effluent monitoring data (if available). In instances of exceedances of projected effluent limitations under the final criteria, EPA determined the likely compliance scenarios and costs. Only compliance actions and costs that would be needed above the baseline level of controls are attributable to the final rule. EPA assumed that dischargers will pursue the least cost means of compliance with WQBELs. Incremental compliance actions attributable to the final rule may include pollution prevention, end-of-pipe treatment, and alternative compliance mechanisms (e.g., variances). EPA annualized one- 69 The CWA does not regulate nonpoint sources. However, EPA recognizes that the state may require controls for nonpoint sources as part of potential incremental TMDLs. It is difficult to model and evaluate the potential cost impacts of this final rule to nonpoint sources because they are intermittent, variable, and occur under hydrologic or climatic conditions associated with precipitation events. Also, data on instream and discharge levels of the pollutants of concern after dischargers have implemented controls to meet current WQS, total maximum daily loads (TMDLs) for impaired waters, or other water quality improvement plans, are not available. Therefore, trying to determine which sources would not achieve WQS based on the revised human health criteria after complying with existing regulations and policies may not be possible. In addition, legacy contamination (e.g., in sediment) may be a source of ongoing loading. Atmospheric deposition may also contribute loadings of the pollutants of concern (e.g., mercury). EPA did not estimate sediment remediation costs, or air pollution controls costs, for this analysis because EPA did not have data on the contribution of these sources, and because control costs for deposition may be covered by Clean Air Act rules. VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\28NOR1.SGM 28NOR1 85434 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations mstockstill on DSK3G9T082PROD with RULES time costs (capital costs and variance costs) over 20 years using a 3 percent discount rate to obtain total annual costs per facility. For the random sample, EPA extrapolated the annualized costs based on the sampling weight for each sample facility. To obtain an estimate of total costs to point sources, EPA added the results for the certainty sample to the extrapolated random sample costs. C. Results Based on the results for 17 sample facilities across 8 industrial and municipal categories,70 EPA estimated a total annual compliance cost of approximately $126,000 to $150,000 for all major dischargers in the state (using a 3 percent discount rate). Only five facilities are estimated to incur pollution prevention program costs, while two facilities are expected to also incur costs of obtaining a variance. Most of the facilities would not bear any cost. The low end of the range reflects the assumption that the compliance actions (e.g., pollution prevention) will result in compliance with projected effluent limits, whereas the high scenario reflects projected effluent limits not being met, and thus includes the estimated administrative cost of also obtaining a variance. All compliance costs are for industrial facilities, and are attributable to the human health criterion for methylmercury. If the revised criteria result in an incremental increase in impaired waters, resulting in the need for TMDL development, there could also be some costs to nonpoint sources of pollution. Using available ambient monitoring data, EPA compared pollutant concentrations to the baseline and final criteria, identifying waterbodies that may be incrementally impaired (i.e., impaired under the final criteria but not under the baseline). For the parameters and stations for which EPA had sufficient monitoring data available to evaluate, there were 50 impairments under the baseline criteria and 124 under the final criteria, for a total of 74 potential incremental impairments (or a 148 percent increase relative to the baseline; including for methylmercury, PCBs, and DDT). This increase indicates the potential for nonpoint sources to bear some compliance costs, although data are not available to estimate the magnitude of these costs. The control of nonpoint sources such as in the context of a TMDL could result in different 70 Seven industrial categories (mining, food and kindred products, paper and allied products, chemicals and allied products, petroleum refining and related industries, primary metal industries, and transportation and public utilities (except POTWs)) and municipal POTWs. VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 requirements, and thus different costs, for point sources. If the net increase in potential impairments is any indication of the potential increase in the number of TMDLs, then the total administrative costs for TMDL development could be in the range of $2.7 million to $3.0 million based on national average single-cause single-waterbody TMDL development costs from U.S. EPA (2001; updated to 2014 dollars). However, these costs may be reduced if Ecology develops multi-cause or multiwaterbody TMDLs. If these costs are spread over 8 to 15 years, at a discount rate of 3 percent, the annualized costs of developing TMDLs are $229,000 to $422,000. Combining the potential facility compliance costs and TMDL administrative costs results in total annual costs of $355,000 to $572,000, at a 3 percent discount rate. V. Statutory and Executive Order Reviews A. Executive Order 12866 (Regulatory Planning and Review) and Executive Order 13563 (Improving Regulation and Regulatory Review) It has been determined that this final rule is not a ‘‘significant regulatory action’’ under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is, therefore, not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). The final rule does not establish any requirements directly applicable to regulated entities or other sources of toxic pollutants. However, these WQS may serve as a basis for development of NPDES permit limits. Washington has NPDES permitting authority, and retains considerable discretion in implementing standards. In the spirit of Executive Order 12866, EPA evaluated the potential costs to NPDES dischargers associated with state implementation of EPA’s final criteria. This analysis, Final Economic Analysis for the Revision of Certain Federal Water Quality Criteria Applicable to Washington, is summarized in section IV of the preamble and is available in the docket. B. Paperwork Reduction Act This action does not impose any direct new information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Actions to implement these WQS could entail additional paperwork burden. Burden is defined at 5 CFR 1320.3(b). This action does not include any information collection, reporting, or record-keeping requirements. PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 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. This action will not impose any requirements on small entities. EPA has the authority to promulgate WQS in any case where the Administrator determines that a new or revised standard is necessary to meet the requirements of the CWA. EPApromulgated standards are implemented through various water quality control programs including the NPDES program, which limits discharges to navigable waters except in compliance with an NPDES permit. The CWA requires that all NPDES permits include any limits on discharges that are necessary to meet applicable WQS. Thus, under the CWA, EPA’s promulgation of WQS establishes standards that the state implements through the NPDES permit process. The state has discretion in developing discharge limits, as needed to meet the standards. As a result of this action, the State of Washington will need to ensure that permits it issues include any limitations on discharges necessary to comply with the standards established in the final rule. In doing so, the state will have a number of choices associated with permit writing. While Washington’s implementation of the rule may ultimately result in new or revised permit conditions for some dischargers, including small entities, EPA’s action, by itself, does not impose any of these requirements on small entities; that is, these requirements are not self-implementing. D. Unfunded Mandates Reform Act This action contains no federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531– 1538 for state, local, or tribal governments or the private sector. As these water quality criteria are not selfimplementing, EPA’s action imposes no enforceable duty on any state, local or tribal governments or the private sector. Therefore, this action is not subject to the requirements of sections 202 or 205 of UMRA. This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that could significantly or uniquely affect small governments. 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 E:\FR\FM\28NOR1.SGM 28NOR1 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations government and the states, or on the distribution of power and responsibilities among the various levels of government. This rule does not alter Washington’s considerable discretion in implementing these WQS, nor will it preclude Washington from adopting WQS in the future that EPA concludes meet the requirements of the CWA, which will eliminate the need for federal standards. Thus, Executive Order 13132 does not apply to this action. mstockstill on DSK3G9T082PROD with RULES F. Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments) This action has tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. In the State of Washington, there are 29 federally recognized Indian tribes. To date, nine of these Indian tribes have been approved for TAS for CWA sections 303 and 401.71 Of these nine tribes, seven have EPA-approved WQS in their respective jurisdictions.72 This rule could affect federally recognized Indian tribes in Washington because the numeric criteria for Washington will apply to waters adjacent to (or upstream or downstream of) the tribal waters, where many of those tribes have treaty rights to take fish for their subsistence. Additionally, there are ten federally recognized Indian tribes in the Columbia River Basin located in the states of Oregon and Idaho that this rule could impact because their waters could affect or be affected by the water quality of Washington’s downstream or upstream waters. EPA consulted with federally recognized tribal officials under EPA’s Policy on Consultation and Coordination with Indian Tribes early in the process of developing this rule to permit them to have meaningful and timely input into its development. In February and March 2015, EPA held tribes-only technical staff and leadership consultation sessions to hear their views and answer questions of all interested tribes on the proposed rule. Representatives from approximately 23 tribes and four tribal consortia participated in two leadership meetings held in March 2015. EPA and tribes 71 https://water.epa.gov/scitech/swguidance/ standards/wqslibrary/approvtable.cfm. 72 https://yosemite.epa.gov/r10/water.nsf/ 34090d07b77d50bd88256b79006529e8/dd2a4 df00fd7ae1a88256e0500680e86!OpenDocument. Note that this number does not include the Confederated Tribes of the Colville Reservation, which has federally promulgated WQS from 1989. EPA is currently reviewing the Colville Tribe’s application for TAS. VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 have also met regularly since November 2012 to discuss Washington’s human health criteria at both the tribal leadership level and technical staff level. The tribes have repeatedly asked EPA to promulgate federal human health criteria for Washington if the state did not do so in a timely and protective manner. At these meetings, the tribes consistently emphasized that the human health criteria should be derived using at least a minimum FCR value of 175 g/day, a cancer risk level of 10¥6, and the latest scientific information from EPA’s 304(a) recommended criteria. EPA considered the input received during consultation with tribes when developing this final rule (see section III for additional discussion of how EPA considered tribal input). In subsequent coordination with tribes, EPA received a letter on August 5, 2016, from the Northwest Indian Fisheries Commission disagreeing with EPA’s potential adjustments to the RSC from the proposed rule issued on September 14, 2015 to the final rule as a result of public comments. The tribes expressed concern that less stringent human health criteria as a result of the RSC adjustment would result in lower protection of designated uses and limit the ability to exercise tribal treaty rights, especially in light of a FCR that underestimates tribal consumption. EPA considered this information carefully before finalizing this rule, but for the reasons stated above, decided to adjust the RSC to account for inclusion of some marine fish in the FCR. This results in protective criteria that account for other routes of exposure in addition to drinking water and fish and shellfish from inland and nearshore waters and is consistent with EPA’s guidance. G. Executive Order 13045 (Protection of Children From Environmental Health and Safety Risks) 85435 I. National Technology Transfer and Advancement Act of 1995 This final rulemaking does not involve technical standards. J. Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations) This action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. Conversely, this action identifies and ameliorates disproportionately high and adverse human health effects on minority populations and low-income populations in Washington. EPA developed the human health criteria included in this final rule specifically to protect Washington’s designated uses, using the most current science, including local and regional information on fish consumption. Applying these criteria to waters in the State of Washington will afford a greater level of protection to both human health and the environment. 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). List of Subjects in 40 CFR Part 131 Environmental protection, Indianslands, Intergovernmental relations, Reporting and recordkeeping requirements, Water pollution control. Dated: November 15, 2016. Gina McCarthy, Administrator. For the reasons set forth in the preamble, EPA amends 40 CFR part 131 as follows: PART 131—WATER QUALITY STANDARDS 1. The authority citation for part 131 continues to read as follows: This rule is not subject to Executive Order 13045, because it is not economically significant as defined in Executive Order 12866, and because the environmental health or safety risks addressed by this action do not present a disproportionate risk to children. ■ H. Executive Order 13211 (Actions That Significantly Affect Energy Supply, Distribution, or Use) ■ 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. § 131.45 Revision of certain Federal water quality criteria applicable to Washington. PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 Authority: 33 U.S.C. 1251 et seq. Subpart D—Federally Promulgated Water Quality Standards § 131.36 [Amended] 2. In § 131.36, remove paragraph (d)(14). ■ 3. Add § 131.45 to read as follows: (a) Scope. This section promulgates human health criteria for priority toxic E:\FR\FM\28NOR1.SGM 28NOR1 85436 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations pollutants in surface waters in Washington. (b) Criteria for priority toxic pollutants in Washington. The applicable human health criteria are shown in Table 1. TABLE 1—HUMAN HEALTH CRITERIA FOR WASHINGTON A B C mstockstill on DSK3G9T082PROD with RULES CAS No. 1. 1,1,1-Trichloroethane ...................... 2. 1,1,2,2-Tetrachloroethane ............... 3. 1,1,2-Trichloroethane ...................... 4. 1,1-Dichloroethylene ....................... 5. 1,2,4-Trichlorobenzene ................... 6. 1,2-Dichlorobenzene ....................... 7. 1,2-Dichloroethane .......................... 8. 1,2-Dichloropropane ........................ 9. 1,2-Diphenylhydrazine .................... 10. 1,2-Trans-Dichloroethylene ........... 11. 1,3-Dichlorobenzene ..................... 12. 1,3-Dichloropropene ...................... 13. 1,4-Dichlorobenzene ..................... 14. 2,3,7,8-TCDD (Dioxin) ** ............... 15. 2,4,6-Trichlorophenol .................... 16. 2,4-Dichlorophenol ........................ 17. 2,4-Dimethylphenol ....................... 18. 2,4-Dinitrophenol ........................... 19. 2,4-Dinitrotoluene .......................... 20. 2-Chloronaphthalene ..................... 21. 2-Chlorophenol .............................. 22. 2-Methyl-4,6-Dinitrophenol ............ 23. 3,3′-Dichlorobenzidine .................. 24. 3-Methyl-4-Chlorophenol ............... 25. 4,4′-DDD ....................................... 26. 4,4′-DDE ....................................... 27. 4,4′-DDT ........................................ 28. Acenaphthene ............................... 29. Acrolein ......................................... 30. Acrylonitrile .................................... 31. Aldrin ............................................. 32. alpha-BHC ..................................... 33. alpha-Endosulfan .......................... 34. Anthracene .................................... 35. Antimony ....................................... 36. Arsenic ** ....................................... 37. Asbestos ....................................... 38. Benzene ........................................ 39. Benzidine ...................................... 40. Benzo(a) Anthracene .................... 41. Benzo(a) Pyrene ........................... 42. Benzo(b) Fluoranthene ................. 43. Benzo(k) Fluoranthene ................. 44. beta-BHC ...................................... 45. beta-Endosulfan ............................ 46. Bis(2-Chloroethyl) Ether ................ 47. Bis(2-Chloro-1-Methylethyl) Ether * 48. Bis(2-Ethylhexyl) Phthalate ........... 49. Bromoform .................................... 50. Butylbenzyl Phthalate ................... 51. Carbon Tetrachloride .................... 52. Chlordane ...................................... 53. Chlorobenzene .............................. 54. Chlorodibromomethane ................. 55. Chloroform .................................... 56. Chrysene ....................................... 57. Copper .......................................... 58. Cyanide ......................................... 59. Dibenzo(a,h) Anthracene .............. 60. Dichlorobromomethane ................. 61. Dieldrin .......................................... 62. Diethyl Phthalate ........................... 63. Dimethyl Phthalate ........................ 64. Di-n-Butyl Phthalate ...................... 65. Endosulfan Sulfate ........................ 66. Endrin ............................................ 67. Endrin Aldehyde ............................ 68. Ethylbenzene ................................ 69. Fluoranthene ................................. 70. Fluorene ........................................ 71. gamma-BHC; Lindane .................. VerDate Sep<11>2014 16:28 Nov 25, 2016 71556 79345 79005 75354 120821 95501 107062 78875 122667 156605 541731 542756 106467 1746016 88062 120832 105679 51285 121142 91587 95578 534521 91941 59507 72548 72559 50293 83329 107028 107131 309002 319846 959988 120127 7440360 7440382 1332214 71432 92875 56553 50328 205992 207089 319857 33213659 111444 108601 117817 75252 85687 56235 57749 108907 124481 67663 218019 7440508 57125 53703 75274 60571 84662 131113 84742 1031078 72208 7421934 100414 206440 86737 58899 Jkt 241001 Cancer slope factor, CSF (per mg/ kg·d) Relative source contribution, RSC (-) Reference dose, RfD (mg/kg·d) Bio-accumulation factor (L/kg tissue) Bio-concentration factor (L/kg tissue) Water & organisms (μg/L) Organisms only (μg/L) (B1) Chemical (B2) (B3) (B4) (B5) (C1) (C2) 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.80 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.50 0.80 0.50 0.50 0.50 0.50 2 .................... .................... 0.05 .................... 0.3 .................... .................... .................... 0.02 0.002 .................... 0.07 .................... .................... 0.003 .................... 0.002 .................... 0.08 .................... 0.0003 .................... .................... .................... .................... .................... 0.06 .................... .................... .................... .................... 0.006 0.3 0.0004 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... 0.04 .................... .................... .................... .................... .................... 0.02 .................... 0.01 .................... .................... 0.0006 .................... .................... .................... 0.8 10 0.1 0.006 0.0003 .................... 0.022 0.04 0.04 0.0047 10 8.4 8.9 2.6 430 82 1.9 ............................ 27 4.7 190 3.0 84 ............................ ............................ 48 ............................ 4.4 ............................ 240 ............................ 10 ............................ ............................ 240,000 3,100,000 1,100,000 510 ............................ ............................ 650,000 1,500 200 610 ............................ ............................ ............................ ............................ ............................ 3,900 3,900 3,900 3,900 180 ............................ ............................ 10 710 8.5 19,000 ............................ 60,000 22 5.3 3.8 3,900 ............................ ............................ 3,900 4.8 410,000 920 4,000 2,900 140 46,000 ............................ 160 1,500 710 2,500 ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ 5,000 ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ 1 44 ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ 1 ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ 20,000 0.1 0.35 700 0.036 700 8.9 .................. 0.01 200 2 0.22 200 1.3E-08 .................. 10 .................. 30 .................. 100 .................. 3 .................. .................. 7.9E-06 8.8E-07 1.2E-06 30 .................. .................. 4.1E-08 4.8E-05 6 100 6 a 0.018 .................. .................. .................. 0.00016 1.6E-05 0.00016 0.0016 0.0013 .................. .................. 400 0.045 4.6 0.013 .................. 2.2E-05 100 0.60 100 0.016 .................. 9 1.6E-05 0.73 7.0E-08 200 600 8 9 0.002 .................. 29 6 10 0.43 50,000 0.3 0.90 4,000 0.037 800 73 ........................ 0.02 1,000 2 1.2 200 1.4E-08 ........................ 10 ........................ 100 ........................ 100 ........................ 7 ........................ ........................ 7.9E-06 8.8E-07 1.2E-06 30 ........................ ........................ 4.1E-08 4.8E-05 7 100 90 a 0.14 ........................ ........................ ........................ 0.00016 1.6E-05 0.00016 0.0016 0.0014 ........................ ........................ 900 0.046 12 0.013 ........................ 2.2E-05 200 2.2 600 0.016 ........................ 100 1.6E-05 2.8 7.0E-08 200 600 8 ........................ 0.002 ........................ 31 6 10 0.43 Fmt 4700 Sfmt 4700 .................... 0.2 0.057 .................... 0.029 .................... 0.0033 .................... 0.8 .................... .................... 0.122 .................... 156,000 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... 0.24 0.167 0.34 .................... .................... .................... 17 6.3 .................... .................... .................... 1.75 .................... .................... .................... 0.73 7.3 0.73 0.073 1.8 .................... .................... .................... 0.014 0.0045 0.0019 .................... 0.35 .................... 0.04 .................... 0.0073 .................... .................... 7.3 0.034 16 .................... .................... .................... .................... .................... .................... .................... .................... .................... .................... PO 00000 Frm 00036 E:\FR\FM\28NOR1.SGM 28NOR1 85437 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations TABLE 1—HUMAN HEALTH CRITERIA FOR WASHINGTON—Continued A B C 72. 73. 74. 75. 76. 77. 78. 79. 80. 81. 82. 83. 84. 85. 86. 87. 88. 89. 90. 91. 92. 93. 94. 95. 96. 97. 98. 99. CAS No. Heptachlor ..................................... Heptachlor Epoxide ....................... Hexachlorobenzene ...................... Hexachlorobutadiene .................... Hexachlorocyclopentadiene .......... Hexachloroethane ......................... Indeno(1,2,3-cd) Pyrene ............... Isophorone .................................... Methyl Bromide ............................. Methylene Chloride ....................... Methylmercury ............................... Nickel ............................................ Nitrobenzene ................................. N-Nitrosodimethylamine ................ N-Nitrosodi-n-Propylamine ............ N-Nitrosodiphenylamine ................ Pentachlorophenol (PCP) ............. Phenol ........................................... Polychlorinated Biphenyls (PCBs) Pyrene ........................................... Selenium ....................................... Tetrachloroethylene ...................... Thallium ** ..................................... Toluene ......................................... Toxaphene .................................... Trichloroethylene ........................... Vinyl Chloride ................................ Zinc ............................................... 76448 1024573 118741 87683 77474 67721 193395 78591 74839 75092 22967926 7440020 98953 62759 621647 86306 87865 108952 ................ 129000 7782492 127184 7440280 108883 8001352 79016 75014 7440666 Relative source contribution, RSC (-) Reference dose, RfD (mg/kg·d) Bio-accumulation factor (L/kg tissue) Bio-concentration factor (L/kg tissue) Water & organisms (μg/L) Organisms only (μg/L) (B1) Chemical Cancer slope factor, CSF (per mg/ kg·d) (B2) (B3) (B4) (B5) (C1) (C2) .................... .................... .................... .................... 0.006 .................... .................... .................... 0.02 .................... 0.0001 0.02 0.002 .................... .................... .................... .................... 0.6 .................... 0.03 0.005 .................... 0.000068 0.0097 .................... .................... .................... 0.3 330,000 35,000 90,000 1,100 1,300 600 3,900 ............................ 1.4 1.6 ............................ ............................ 3.1 ............................ ............................ ............................ 520 1.9 ............................ 860 ............................ 76 ............................ 17 ............................ 13 1.7 ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ ............................ 47 ............................ ............................ ............................ ............................ ............................ ............................ 31,200 ............................ 4.8 ............................ 116 ............................ ............................ ............................ ............................ 47 3.4E-07 2.4E-06 5.0E-06 0.01 1 0.02 0.00016 .................. 300 10 .................. 80 30 .................. .................. .................. 0.002 9,000 c 7E-06 8 60 2.4 1.7 72 .................. 0.3 .................. 1,000 3.4E-07 2.4E-06 5.0E-06 0.01 1 0.02 0.00016 ........................ ........................ 100 b 0.03 (mg/kg) 100 100 ........................ ........................ ........................ 0.002 70,000 c 7E-06 8 200 2.9 6.3 130 ........................ 0.7 0.18 1,000 4.1 5.5 1.02 0.04 .................... 0.04 0.73 .................... .................... 0.002 .................... .................... .................... .................... .................... .................... 0.4 .................... 2 .................... .................... 0.0021 .................... .................... .................... 0.05 1.5 .................... 0.50 0.50 2.7E-05 0.50 0.50 0.50 0.50 0.50 0.50 0.50 a This criterion refers to the inorganic form of arsenic only. criterion is expressed as the fish tissue concentration of methylmercury (mg methylmercury/kg fish). See Water Quality Criterion for the Protection of Human Health: Methylmercury (EPA–823–R–01–001, January 3, 2001) for how this value is calculated using the criterion equation in EPA’s 2000 Human Health Methodology rearranged to solve for a protective concentration in fish tissue rather than in water. c This criterion applies to total PCBs (e.g., the sum of all congener or isomer or homolog or Aroclor analyses). * Bis(2-Chloro-1-Methylethyl) Ether was previously listed as Bis(2-Chloroisopropyl) Ether. ** These criteria were promulgated for Washington in the National Toxics Rule at 40 CFR 131.36, and are moved into 40 CFR 131.45 to have one comprehensive human health criteria rule for Washington. mstockstill on DSK3G9T082PROD with RULES b This (c) Applicability. (1) The criteria in paragraph (b) of this section apply to waters with Washington’s designated uses cited in paragraph (d) of this section and apply concurrently with other applicable water quality criteria. (2) The criteria established in this section are subject to Washington’s general rules of applicability in the same way and to the same extent as are other federally promulgated and stateadopted numeric criteria when applied to the same use classifications in paragraph (d) of this section. (i) For all waters with mixing zone regulations or implementation procedures, the criteria apply at the appropriate locations within or at the boundary of the mixing zones; otherwise the criteria apply throughout the waterbody including at the end of any discharge pipe, conveyance or other discharge point within the waterbody. (ii) The state must not use a low flow value below which numeric noncarcinogen and carcinogen human health criteria can be exceeded that is less stringent than the harmonic mean flow for waters suitable for the VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 establishment of low flow return frequencies (i.e., streams and rivers). Harmonic mean flow is a long-term mean flow value calculated by dividing the number of daily flows analyzed by the sum of the reciprocals of those daily flows. (iii) If the state does not have such a low flow value for numeric criteria, then none will apply and the criteria in paragraph (b) of this section herein apply at all flows. (d) Applicable use designations. (1) All waters in Washington assigned to the following use classifications are subject to the criteria identified in paragraph (d)(2) of this section: (i) Fresh waters— (A) Miscellaneous uses: Harvesting (Fish harvesting); (B) Recreational uses; (C) Water supply uses: Domestic water (Domestic water supply); (ii) Marine waters— (A) Miscellaneous uses: Harvesting (Salmonid and other fish harvesting, and crustacean and other shellfish (crabs, shrimp, scallops, etc.) harvesting); PO 00000 Frm 00037 Fmt 4700 Sfmt 9990 (B) Recreational uses; (C) Shellfish harvesting: Shellfish harvest (Shellfish (clam, oyster, and mussel) harvesting) Note to paragraph (d)(1): The source of these uses is Washington Administrative Code 173–201A–600 for Fresh waters and 173–201A–610 for Marine waters. (2) For Washington waters that include the use classification of Domestic Water, the criteria in column C1 and the methylmercury criterion in column C2 of Table 1 in paragraph (b) of this section apply. For Washington waters that include any of the following use classifications but do not include the use classification of Domestic Water, the criteria in column C2 of Table 1 in paragraph (b) of this section apply: Harvesting (fresh and marine waters), Recreational Uses (fresh and marine waters), and Shellfish Harvesting. [FR Doc. 2016–28424 Filed 11–25–16; 8:45 am] BILLING CODE 6560–50–P E:\FR\FM\28NOR1.SGM 28NOR1

Agencies

[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Rules and Regulations]
[Pages 85417-85437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28424]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[EPA-HQ-OW-2015-0174; FRL-9955-40-OW]
RIN 2040-AF56


Revision of Certain Federal Water Quality Criteria Applicable to 
Washington

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: On September 14, 2015, the Environmental Protection Agency 
(EPA) proposed revisions to the federal Clean Water Act (CWA) human 
health criteria applicable to waters under the State of Washington's 
jurisdiction to ensure that the criteria are set at levels that will 
adequately protect Washington residents, including tribes with treaty-
reserved rights, from exposure to toxic pollutants. EPA promulgated 
Washington's previous criteria for the protection of human health in 
1992 as part of the National Toxics Rule (NTR) (amended in 1999 for 
Polychlorinated Biphenyls (PCBs)), using the Agency's recommended 
criteria values at the time. EPA derived those previously applicable 
criteria using a fish consumption rate (FCR) of 6.5 grams per day (g/
day) based on national surveys. The best available data now demonstrate 
that fish consumers in Washington consume much more fish than 6.5 g/
day. There are also new data and scientific information available to 
update the toxicity and exposure parameters used to calculate human 
health criteria. On August 1, 2016, the State of Washington adopted and 
submitted human health criteria for certain pollutants, reflecting some 
of these new data and information. Concurrent with this final rule, EPA 
is taking action under CWA 303(c) to approve in part, and disapprove in 
part, the human health criteria submitted by Washington. For those 
criteria that EPA disapproved, EPA is finalizing federal human health 
criteria in this final rule.

[[Page 85418]]

EPA is not finalizing criteria in this final rule for those state-
adopted criteria that EPA approved, or for certain criteria that EPA 
has determined involve scientific uncertainty, as explained below.

DATES: This final rule is effective on December 28, 2016.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. EPA-HQ-OW-2015-0174. 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. Publicly available docket 
materials are available electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Erica Fleisig, Office of Water, 
Standards and Health Protection Division (4305T), Environmental 
Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; 
telephone number: (202) 566-1057; email address: fleisig.erica@epa.gov.

SUPPLEMENTARY INFORMATION: This final rule is organized as follows:

I. General Information
    A. Does this action apply to me?
    B. How did EPA develop this final rule?
II. Background
    A. Statutory and Regulatory Background
    B. EPA's CWA 303(c) Action on Washington's Human Health Criteria
    C. General Recommended Approach for Deriving Human Health 
Criteria
III. Derivation of Human Health Criteria for Washington
    A. Scope of Pollutants and Waters Covered by This Final Rule
    B. Washington's Designated Uses and Tribal Reserved Fishing 
Rights
    C. Washington-Specific Human Health Criteria Inputs
    D. Final Human Health Criteria for Washington
    E. Applicability of Criteria
    F. Alternative Regulatory Approaches and Implementation 
Mechanisms
IV. Economic Analysis
    A. Identifying Affected Entities
    B. Method for Estimating Costs
    C. Results
V. 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 and Safety Risks)
    H. Executive Order 13211 (Actions That Significantly Affect 
Energy Supply, Distribution, or Use)
    I. National Technology Transfer and Advancement Act of 1995
    J. Executive Order 12898 (Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations)
    K. Congressional Review Act (CRA)

I. General Information

A. Does this action apply to me?

    Entities such as industries, stormwater management districts, or 
publicly owned treatment works (POTWs) that discharge pollutants to 
waters of the United States under the State of Washington's 
jurisdiction could be indirectly affected by this rulemaking, because 
federal water quality standards (WQS) promulgated by EPA are applicable 
to CWA regulatory programs, such as National Pollutant Discharge 
Elimination System (NPDES) permitting. Citizens concerned with water 
quality in Washington could also be interested in this rulemaking. 
Categories and entities that could potentially be affected include the 
following:

------------------------------------------------------------------------
                                      Examples of potentially affected
             Category                             entities
------------------------------------------------------------------------
Industry..........................  Industries discharging pollutants to
                                     waters of the United States in
                                     Washington.
Municipalities....................  Publicly owned treatment works or
                                     other facilities discharging
                                     pollutants to waters of the United
                                     States in Washington.
Stormwater Management Districts...  Entities responsible for managing
                                     stormwater runoff in the State of
                                     Washington.
------------------------------------------------------------------------

This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities that could be indirectly affected 
by this action. Any parties or entities who depend upon or contribute 
to the water quality of Washington's waters could be indirectly 
affected by this rule. To determine whether your facility or activities 
could be indirectly affected by this action, you should carefully 
examine this rule. If you have questions regarding the applicability of 
this action to a particular entity, consult the person listed in the 
FOR FURTHER INFORMATION CONTACT section.

B. How did EPA develop this final rule?

    In developing this final rule, EPA carefully considered the public 
comments and feedback received from interested parties. EPA originally 
provided a 60-day public comment period after publishing the proposed 
rule in the Federal Register on September 14, 2015.\1\ On October 28, 
2015, in response to stakeholder requests,\2\ EPA extended the public 
comment period for an additional 45 days.\3\ In addition, EPA held two 
virtual public hearings on December 15th and 16th, 2015, to discuss the 
contents of the proposed rule and accept verbal public comments.
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    \1\ See Revision of Certain Federal Water Quality Criteria 
Applicable to Washington: Proposed Rule, 80 FR 55063, September 14, 
2015.
    \2\ EPA received requests from the Association of Washington 
Business--Washington State's Chamber of Commerce, Washington Public 
Ports Association (on behalf of the Association of Washington Cities 
and the Washington State Association of Counties), Western Wood 
Preservers Institute, ALCOA, American Forest and Paper Association, 
McFarland Cascade, Schnitzer Steel Industries, and Weyerhaeuser.
    \3\ See Extension of Public Comment Period for the Revision of 
Certain Federal Water Quality Criteria Applicable to Washington, 80 
FR 65980, October 28, 2015.
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    Over 60 organizations and individuals submitted comments on a range 
of issues. EPA also received over 400 letters from individuals 
associated with mass letter writing campaigns. Some comments addressed 
issues beyond the scope of the rulemaking, and thus EPA did not 
consider them in finalizing this rule. In each section of this 
preamble, EPA discusses certain public comments so that the public is 
aware of the Agency's position. For a full response to these and all 
other comments, see EPA's Response to Comments document in the official 
public docket.

II. Background

A. Statutory and Regulatory Background

    CWA section 101(a)(2) establishes as a national goal ``water 
quality which provides for the protection and propagation of fish, 
shellfish, and wildlife, and recreation in and on the water, wherever 
attainable.'' These are commonly referred to as the ``fishable/
swimmable'' goals of the CWA. EPA

[[Page 85419]]

interprets ``fishable'' uses to include, at a minimum, designated uses 
providing for the protection of aquatic communities and human health 
related to consumption of fish and shellfish.\4\
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    \4\ USEPA. 2000. Memorandum #WQSP-00-03. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC https://www.epa.gov/sites/production/files/2015-01/documents/standards-shellfish.pdf.
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    CWA section 303(c) (33 U.S.C. 1313(c)) directs states to adopt WQS 
for their waters subject to the CWA. CWA section 303(c)(2)(A) and EPA's 
implementing regulations at 40 CFR part 131 require, among other 
things, that a state's WQS specify appropriate designated uses of the 
waters, and water quality criteria that protect those uses. EPA's 
regulations at 40 CFR 131.11(a)(1) provide that ``[s]uch criteria must 
be based on sound scientific rationale and must contain sufficient 
parameters or constituents to protect the designated use. For waters 
with multiple use designations, the criteria shall support the most 
sensitive use.'' In addition, 40 CFR 131.10(b) provides that ``[i]n 
designating uses of a water body and the appropriate criteria for those 
uses, the state shall take into consideration the water quality 
standards of downstream waters and ensure that its water quality 
standards provide for the attainment and maintenance of the water 
quality standards of downstream waters.''
    States are required to review applicable WQS at least once every 
three years and, if appropriate, revise or adopt new standards (CWA 
section 303(c)(1)). Any new or revised WQS must be submitted to EPA for 
review and approval or disapproval (CWA section 303(c)(2)(A) and 
(c)(3)). If EPA disapproves a state's new or revised WQS, the CWA 
provides the state 90 days to adopt a revised WQS that meets CWA 
requirements, and if it fails to do so, EPA shall promptly propose and 
then within 90 days promulgate such standard unless EPA approves a 
state replacement WQS first (CWA section 303(c)(3) and (c)(4)(A)). CWA 
section 303(c)(4)(B) authorizes the Administrator to determine that a 
new or revised standard is needed to meet CWA requirements. Upon making 
such a determination, the CWA specifies that EPA shall promptly 
propose, and then within 90 days promulgate, any such new or revised 
standard unless prior to such promulgation, the state has adopted a 
revised or new WQS that EPA determines to be in accordance with the 
CWA.
    Under CWA section 304(a), EPA periodically publishes criteria 
recommendations for states to consider when adopting water quality 
criteria for particular pollutants to protect the CWA section 101(a)(2) 
goal uses. In 2015, EPA updated its 304(a) recommended criteria for 
human health for 94 pollutants.\5\ Where EPA has published recommended 
criteria, states should establish numeric water quality criteria based 
on EPA's CWA section 304(a) criteria, section 304(a) criteria modified 
to reflect site-specific conditions, or other scientifically defensible 
methods (40 CFR 131.11(b)(1)). In all cases criteria must be sufficient 
to protect the designated use and be based on sound scientific 
rationale (40 CFR 131.11(a)(1)). CWA section 303(c)(2)(B) requires 
states to adopt numeric criteria for all toxic pollutants listed 
pursuant to CWA section 307(a)(1) for which EPA has published 304(a) 
criteria, as necessary to support the states' designated uses.
---------------------------------------------------------------------------

    \5\ Final Updated Ambient Water Quality Criteria for the 
Protection of Human Health, (80 FR 36986, June 29, 2015). See also: 
USEPA. 2015. Final 2015 Updated National Recommended Human Health 
Criteria. U.S. Environmental Protection Agency, Office of Water, 
Washington, DC https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------

    In 1992, EPA promulgated the NTR at 40 CFR 131.36, establishing 
chemical-specific numeric criteria for 85 priority toxic pollutants for 
14 states and territories (states), including Washington, that were not 
in compliance with the requirements of CWA section 303(c)(2)(B). When 
states covered by the NTR subsequently adopted their own criteria for 
toxic pollutants that EPA approved as consistent with the CWA and EPA's 
implementing regulations, EPA amended the NTR to remove those criteria 
for those states.

B. EPA's CWA 303(c) Action on Washington's Human Health Criteria

    On September 14, 2015, EPA made a CWA 303(c)(4)(B) determination 
that new or revised WQS for the protection of human health in 
Washington were necessary to meet the requirements of the CWA, and 
proposed revised human health criteria for the state (see 80 FR 55063). 
At that time, Washington had not yet adopted its own criteria for the 
protection of human health.\6\ On August 1, 2016, Washington adopted 
and submitted statewide human health criteria and new and revised 
implementation provisions. Concurrent with this final rule, EPA 
approved 45 and disapproved 143 of Washington's human health criteria 
under CWA 303(c). EPA is finalizing 144 human health criteria in this 
rule in accordance with CWA section 303(c)(3) and (c)(4) 
requirements.\7\ After the effective date of this final rule, these 
federal criteria will be in effect for CWA purposes along with the 
human health criteria that Washington adopted and EPA approved.
---------------------------------------------------------------------------

    \6\ Washington adopted criteria for the protection of aquatic 
life from toxic pollutants at WAC 173-201A-240.
    \7\ EPA is finalizing a different number of human health 
criteria (144) than it is disapproving (143) in Washington's 2016 
submittal. Washington did not adopt organism-only criteria for 
methylmercury or water-plus-organism and organism-only criteria for 
bis(2-chloro-1-methylethyl) ether. These are priority pollutants 
listed pursuant to CWA section 307(a)(1) for which EPA has 304(a) 
recommended criteria, and, as such, CWA section 303(c)(2)(B) 
requires that states adopt numeric criteria for these pollutants, as 
necessary to support the states' designated uses. Therefore, EPA is 
including these three criteria in this final rule for Washington. 
This final rule, however, does not include revised water-plus-
organism and organism-only criteria for arsenic, as explained below 
in section III.A, even though EPA is disapproving the arsenic 
criteria in Washington's submittal.
---------------------------------------------------------------------------

    Several commenters provided comments on the timing of EPA's rule, 
and the relationship between EPA's federal rulemaking and the state 
rulemaking process. These comments are now, for the most part, mooted 
by EPA's finalization of its federal rule and action on the state's 
submittal. For additional responses to specific comments, see EPA's 
Response to Comment document in the docket for this rule.

C. General Recommended Approach for Deriving Human Health Criteria

    Human health criteria are designed to minimize the risk of adverse 
cancer and non-cancer effects occurring from lifetime exposure to 
pollutants through the ingestion of drinking water and consumption of 
fish and shellfish obtained from inland and nearshore waters (by 
nearshore waters, EPA refers to waters out to three miles from the 
coast). EPA's practice is to establish a human health 304(a) 
recommended criterion for both drinking water and consumption of fish 
and shellfish from inland and nearshore waters combined, and a separate 
human health criterion based only on ingestion of fish and shellfish 
from inland and nearshore waters. This latter criterion applies in 
cases where the designated uses of a waterbody include supporting fish 
and shellfish for human consumption but not drinking water supply 
sources (e.g., in non-potable estuarine waters).
    The criteria are based on two types of biological endpoints: (1) 
Carcinogenicity and (2) systemic toxicity (i.e., all adverse effects 
other than cancer). EPA takes an integrated approach and considers both 
cancer and non-cancer effects when deriving human health criteria. 
Where sufficient data are available, EPA derives criteria using

[[Page 85420]]

both carcinogenic and non-carcinogenic toxicity endpoints and 
recommends the lower value. Human health criteria for carcinogenic 
effects are calculated using the following input parameters: Cancer 
slope factor (CSF), cancer risk level, body weight, drinking water 
intake rate, fish consumption rate, and a bioaccumulation factor(s). 
Human health criteria for non-carcinogenic and nonlinear carcinogenic 
effects are calculated using a reference dose (RfD) in place of a CSF 
and cancer risk level, and a relative source contribution (RSC) factor, 
which is intended to ensure that an individual's total exposure to a 
given pollutant from all sources does not exceed the RfD. Each of these 
inputs is discussed in more detail below and in EPA's 2000 Human Health 
Methodology (hereafter referred to as EPA's ``2000 Methodology'').\8\
---------------------------------------------------------------------------

    \8\ USEPA. 2000. Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC EPA-822-B-00-004. 
https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------

a. Cancer Risk Level

    EPA's 304(a) national recommended human health criteria are 
typically based on the assumption that carcinogenicity is a ``non-
threshold phenomenon,'' which means that there are no ``no-effect'' 
levels, because even extremely small doses are assumed to cause a 
finite increase in the incidence of cancer. Therefore, EPA calculates 
304(a) human health criteria for carcinogenic effects as pollutant 
concentrations corresponding to lifetime increases in the risk of 
developing cancer.\9\ EPA calculates its 304(a) human health criteria 
values at a 10-6 (one in one million) cancer risk level and 
recommends cancer risk levels of 10-6 or 10-5 
(one in one hundred thousand) for the general population.\10\ EPA notes 
that states and authorized tribes can also choose a more stringent risk 
level, such as 10-7 (one in ten million), when deriving 
human health criteria.
---------------------------------------------------------------------------

    \9\ As noted above, EPA recommends the criterion derived for 
non-carcinogenic effects if it is more protective (lower) than that 
derived for carcinogenic effects.
    \10\ EPA's 2000 Methodology also states: ``Criteria based on a 
10-5 risk level are acceptable for the general population 
as long as states and authorized tribes ensure that the risk to more 
highly exposed subgroups (sport fishers or subsistence fishers) does 
not exceed the 10-4 level.'' Since EPA is establishing 
final criteria to protect a target general population of tribes with 
reserved subsistence fishing rights in Washington waters, the 
applicable EPA-recommended cancer risk levels would relate to that 
target general population, as opposed to the general population of 
Washington residents overall. See section III for additional 
discussion.
---------------------------------------------------------------------------

    If the pollutant is not considered to have the potential for 
causing cancer in humans (i.e., systemic toxicants), EPA assumes that 
the pollutant has a threshold (the RfD) below which a physiological 
mechanism exists to avoid or overcome the adverse effects of the 
pollutant.
b. Cancer Slope Factor and Reference Dose
    A dose-response assessment is required to understand the 
quantitative relationships between exposure to a pollutant and the 
onset of human health effects. EPA evaluates dose-response 
relationships derived from animal toxicity and human epidemiological 
studies to derive dose-response metrics. For carcinogenic toxicological 
effects, EPA uses an oral CSF to derive human health criteria. The oral 
CSF is an upper bound, approximating a 95 percent confidence limit, on 
the increased cancer risk from a lifetime oral exposure to a stressor. 
For non-carcinogenic effects, EPA uses the RfD to calculate human 
health criteria. A RfD is an estimate of a daily oral exposure of an 
individual to a substance that is likely to be without an appreciable 
risk of deleterious effects during a lifetime. A RfD is typically 
derived from a laboratory animal dosing study in which a no-observed-
adverse-effect level (NOAEL), lowest-observed-adverse-effect level 
(LOAEL), or benchmark dose can be obtained. Uncertainty factors are 
applied to reflect the limitations of the data. EPA's Integrated Risk 
Information System (IRIS) \11\ was the primary source of toxicity 
values (i.e., RfD and CSF) for EPA's 2015 updated 304(a) human health 
criteria.\12\ For some pollutants, however, more recent peer-reviewed 
and publicly available toxicological data were available from other EPA 
program offices (e.g., Office of Pesticide Programs, Office of Water, 
Office of Land and Emergency Management), other national and 
international programs, and state programs.
---------------------------------------------------------------------------

    \11\ USEPA. Integrated Risk Information System (IRIS). U.S. 
Environmental Protection Agency, Office of Research and Development, 
Washington, DC www.epa.gov/iris.
    \12\ Final Updated Ambient Water Quality Criteria for the 
Protection of Human Health, (80 FR 36986, June 29, 2015). See also: 
USEPA. 2015. Final 2015 Updated National Recommended Human Health 
Criteria. U.S. Environmental Protection Agency, Office of Water, 
Washington, DC https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------

c. Exposure Assumptions
    EPA's latest 304(a) national human health criteria use a default 
drinking water intake rate of 2.4 liters per day (L/day) and default 
rate of 22 g/day for consumption of fish and shellfish from inland and 
nearshore waters, multiplied by pollutant-specific bioaccumulation 
factors (BAFs) to account for the amount of the pollutant in the edible 
portions of the ingested species. EPA's 2000 Methodology for deriving 
human health criteria emphasizes using, when possible, measured or 
estimated BAFs, which account for chemical accumulation in aquatic 
organisms from all potential exposure routes.\13\ In the 2015 national 
304(a) human health criteria update, EPA primarily used field-measured 
BAFs, and laboratory-measured bioconcentration factors (BCFs) with 
applicable food chain multipliers available from peer-reviewed, 
publicly available databases, to develop national BAFs for three 
trophic levels of fish. If this information was not available, EPA 
selected octanol-water partition coefficients (Kow values) 
from peer-reviewed sources for use in calculating national BAFs.\14\
---------------------------------------------------------------------------

    \13\ USEPA. 2000. Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC EPA-822-B-00-004. 
https://www.epa.gov/wqc/human-health-water-quality-criteria.
    \14\ Final Updated Ambient Water Quality Criteria for the 
Protection of Human Health, (80 FR 36986, June 29, 2015). See also: 
USEPA. 2015. Final 2015 Updated National Recommended Human Health 
Criteria. U.S. Environmental Protection Agency, Office of Water, 
Washington, DC https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------

    EPA's national default drinking water intake rate of 2.4 L/day 
represents the per capita estimate of combined direct and indirect 
community water ingestion at the 90th percentile for adults ages 21 and 
older.\15\ EPA's national default FCR of 22 g/day represents the 90th 
percentile consumption rate of fish and shellfish from inland and 
nearshore waters for the U.S. adult population 21 years of age and 
older, based on National Health and Nutrition Examination Survey 
(NHANES) data from 2003 to 2010.16 17 EPA calculates

[[Page 85421]]

human health criteria using a default body weight of 80 kilograms (kg), 
the average weight of a U.S. adult age 21 and older, based on NHANES 
data from 1999 to 2006.
---------------------------------------------------------------------------

    \15\ USEPA. 2011. EPA Exposure Factors Handbook. 2011 edition 
(EPA 600/R-090/052F). https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=236252.
    \16\ USEPA. 2014. Estimated Fish Consumption Rates for the U.S. 
Population and Selected Subpopulations (NHANES 2003-2010). United 
States Environmental Protection Agency, Washington, DC EPA 820-R-14-
002.
    \17\ EPA's national FCR is based on the total rate of 
consumption of fish and shellfish from inland and nearshore waters 
(including fish and shellfish from local, commercial, aquaculture, 
interstate, and international sources). This is consistent with a 
principle that each state does its share to protect people who 
consume fish and shellfish that originate from multiple 
jurisdictions. USEPA. January 2013. Human Health Ambient Water 
Quality Criteria and Fish Consumption Rates: Frequently Asked 
Questions. https://www.epa.gov/wqc/human-health-ambient-water-quality-criteria-and-fish-consumption-rates-frequently-asked.
---------------------------------------------------------------------------

    Although EPA uses these default values to calculate national 304(a) 
recommended human health criteria, EPA's 2000 Methodology notes a 
preference for the use of local data to calculate human health criteria 
(e.g., locally derived FCRs, drinking water intake rates and body 
weights, and waterbody-specific bioaccumulation rates) over national 
default values, where data are sufficient to do so, to better represent 
local conditions.\18\ It is also important, where sufficient data are 
available, to select a FCR that reflects consumption that is not 
suppressed by concerns about the safety of available 
fish.19 20 Deriving human health criteria using an 
unsuppressed FCR furthers the restoration goals of the CWA and ensures 
protection of human health-related designated uses (as pollutant levels 
decrease, fish habitats are restored, and fish availability increases 
over time). See section III for additional discussion regarding use of 
an unsuppressed FCR to protect a subsistence or sustenance fishing use, 
especially where the subsistence or sustenance use is based in whole or 
in part on tribal treaty or other reserved fishing rights.\21\
---------------------------------------------------------------------------

    \18\ USEPA. 2000. Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC EPA-822-B-00-004. 
https://www.epa.gov/wqc/human-health-water-quality-criteria.
    \19\ USEPA. January 2013. Human Health Ambient Water Quality 
Criteria and Fish Consumption Rates: Frequently Asked Questions. 
https://www.epa.gov/wqc/human-health-ambient-water-quality-criteria-and-fish-consumption-rates-frequently-asked.
    \20\ National Environmental Justice Advisory Council, Fish 
Consumption and Environmental Justice, p.44 (2002) available at 
https://www.epa.gov/sites/production/files/2015-02/documents/fish-consump-report_1102.pdf.
    \21\ The term ``subsistence'' is coterminous with ``sustenance'' 
in this context. Hereafter, the document uses the term 
``subsistence.''
---------------------------------------------------------------------------

d. Relative Source Contribution
    When deriving human health criteria for non-carcinogens and 
nonlinear carcinogens, EPA recommends including a RSC factor to account 
for sources of exposure other than drinking water and fish and 
shellfish from inland and nearshore waters, so that the pollutant 
effect threshold (i.e., RfD) is not apportioned to drinking water and 
fish consumption alone. The rationale for this approach is that for 
pollutants exhibiting threshold effects, the objective of the human 
health criteria is to ensure that an individual's total exposure from 
all sources does not exceed that threshold level. These other exposures 
include exposure to a particular pollutant from ocean fish and 
shellfish consumption (which is not included in EPA's default national 
FCR), non-fish food consumption (e.g., fruits, vegetables, grains, 
meats, poultry), dermal exposure, and inhalation exposure. EPA's 
guidance includes a procedure for determining an appropriate RSC value 
ranging from 0.2 to 0.8 for a given pollutant.

III. Derivation of Human Health Criteria for Washington

A. Scope of Pollutants and Waters Covered by This Final Rule

    In 1992, EPA did not establish human health criteria in the NTR for 
some priority toxic pollutants because, as stated in the preamble to 
the final rule at 57 FR 60848, December 22, 1992, EPA had no 304(a) 
recommendations for those pollutants at the time. EPA now has 304(a) 
recommendations for 99 priority toxic pollutants listed pursuant to CWA 
section 307(a)(1) (85 for which EPA established criteria in the NTR, 
plus 14 additional pollutants).
    After consideration of all comments received on EPA's proposed 
rule, and EPA's CWA 303(c) action on Washington's submittal, EPA is 
finalizing 144 new and revised Washington-specific criteria for 
priority toxic pollutants in this rule. For arsenic, dioxin and 
thallium, EPA is not revising Washington's existing criteria from the 
NTR at this time, as explained below and in EPA's Response to Comments 
document in the docket for the final rule. For those priority 
pollutants for which EPA does not have 304(a) national recommended 
criteria, and are therefore not included in Washington's submittal or 
this final rule, EPA expects that Washington will continue to apply its 
existing narrative toxics criterion in the state's WQS at WAC 173-201A-
260(2)(a).
    Several commenters raised concerns about the scientific 
defensibility of EPA's proposed human health criteria for arsenic, and 
one commenter raised similar concerns about EPA's proposed criteria for 
2,3,7,8-TCDD (dioxin). Additionally, after EPA proposed revised human 
health criteria for thallium in Washington, EPA further evaluated the 
scientific uncertainty around the appropriate RfD for thallium. EPA 
carefully considered all of these comments and information regarding 
these three pollutants, along with the comments that articulated it is 
important for Washington to have protective numeric criteria in place 
for priority toxic pollutants such as arsenic and dioxin. Given the 
scientific uncertainty regarding aspects of the science upon which the 
proposed human health criteria for arsenic, dioxin, and thallium were 
based, EPA is withdrawing its proposal of revised criteria for these 
three pollutants at this time and leaving the existing criteria from 
the NTR in effect for CWA purposes.\22\ EPA did not update the 304(a) 
national recommended criteria for these three pollutants in 2015. As 
noted earlier, IRIS was the primary source of toxicity values (i.e., 
RfD and CSF) for EPA's 2015 updated 304(a) human health criteria. For 
thallium, EPA's IRIS database does not currently contain an estimate of 
thallium's toxicity (i.e., a RfD).\23\ For dioxin, IRIS does not 
currently contain a measure of dioxin's cancer-causing ability (i.e., a 
CSF).\24\ Without such values, EPA has concluded that further analysis 
is necessary in order to promulgate scientifically sound revised 
criteria for these two pollutants. For arsenic, there is uncertainty 
surrounding the toxicological assessment with respect to human health 
effects. EPA's current plan for addressing the arsenic issues is 
described in the Assessment Development Plan for the Integrated Risk 
Information System (IRIS) Toxicological Review of Inorganic Arsenic 
(EPA/630/R-14/101, November 2015). EPA intends to reevaluate the 
existing federal arsenic, dioxin and thallium human health criteria for 
Washington by 2018, with particular consideration of any relevant 
toxicity and bioaccumulation information.
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    \22\ EPA is moving Washington's existing arsenic, dioxin and 
thallium criteria from the NTR into 40 CFR 131.45 to have one 
comprehensive human health criteria rule for Washington.
    \23\ https://cfpub.epa.gov/ncea/iris/index.cfm?fuseaction=iris.showQuickView&substance_nmbr=1012.
    \24\ https://cfpub.epa.gov/ncea/iris/index.cfm?fuseaction=iris.showQuickView&substance_nmbr=1024.
---------------------------------------------------------------------------

    This rule revises the criteria that EPA promulgated for Washington 
in the NTR (with the exception of criteria for arsenic, dioxin, and 
thallium, and criteria that EPA approved in Washington's August 1, 2016 
submittal), and establishes new human health criteria for 8 additional 
chemicals for which EPA now has 304(a) recommended criteria (and for 
which EPA did not approve Washington's submitted criteria): Selenium, 
Zinc, 1,2-Trans-Dichloroethylene, Acenaphthene, Butylbenzyl Phthalate, 
2-Chloronaphthalene, 1,1,1-Trichloroethane, and 1,2,4-Trichlorobenzene. 
In 2001, EPA

[[Page 85422]]

replaced its 304(a) recommended human health criteria for total mercury 
with a fish tissue-based human health criterion for methylmercury.\25\ 
Washington did not include human health criteria for mercury or 
methylmercury in its August 1, 2016 submittal. Therefore, with this 
final rule, EPA replaces the criteria for total mercury that EPA 
promulgated for Washington in the NTR with a methylmercury fish tissue 
criterion, based on EPA's 2001 304(a) recommendation but adjusted to 
incorporate the 175 g/day FCR that EPA used to derive revised human 
health criteria in Washington, as well as EPA's 2015 updated national 
default body weight of 80 kg.
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    \25\ USEPA. 2001. Guidance for Implementing the January 2001 
Methylmercury Water Quality Criterion. U.S. Environmental Protection 
Agency, Office of Water, Washington, DC EPA-823-R-01-001. https://www.epa.gov/wqc/guidance-implementing-january-2001-methylmercury-water-quality-criterion.
---------------------------------------------------------------------------

    A few commenters expressed concern that Washington would not have 
the data or implementation guidance to properly implement a fish tissue 
criterion for methylmercury, and requested that EPA leave the NTR total 
mercury criteria in effect in Washington. The fish tissue methylmercury 
criterion reflects EPA's 2000 Methodology, the best available science, 
and supersedes all previous 304(a) human health mercury criteria 
recommendations published by EPA (except for the waters of the Great 
Lakes System), including the 304(a) recommended criteria that served as 
the basis for the total mercury criteria that EPA promulgated for 
Washington in the NTR. EPA recommends a fish tissue water quality 
criterion for methylmercury for many reasons. A fish tissue water 
quality criterion integrates spatial and temporal complexity that 
occurs in aquatic systems and affects methylmercury bioaccumulation. 
For this pollutant, a fish tissue criterion is more closely tied to the 
goal of protecting human health because it is based directly on the 
dominant human exposure route for methylmercury in the U.S., which is 
consumption of fish and shellfish. The concentration of methylmercury 
is also generally easier to quantify in fish tissue than in water and 
is less variable in fish and shellfish tissue over the time periods in 
which WQS are typically implemented in water quality-based controls, 
such as NPDES permits. Finally, fish consumption advisories for mercury 
are also based on the amount of methylmercury in fish tissue.\26\ While 
the purpose of a fish advisory is different from the purpose of a water 
quality criterion, it will be helpful to the public to have water 
quality criteria and fish consumption advisories for methylmercury 
expressed using the same terms. In response to comments regarding 
implementation of the methylmercury criterion, in 2010, EPA published 
the comprehensive Guidance for Implementing the January 2001 
Methylmercury Water Quality Criterion (EPA 823-R-10-001), to aid states 
in implementing the fish tissue-based methylmercury water quality 
criterion. EPA is confident that Washington will be able to implement 
the fish tissue criterion using the information contained in that 
document, and EPA remains available to offer assistance in doing so. 
Thus there is no need or requirement to leave the NTR total mercury 
criteria in place in Washington.
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    \26\ While both water quality criteria and fish consumption 
advisories are designed ultimately to protect human health, they 
represent very different values and goals. Water quality criteria 
express or establish a desired condition and must protect the 
designated use, such as subsistence fishing. Fish consumption 
advisories start with existing levels of fish contamination 
resulting from impaired water quality, and provide advice to 
populations consuming such fish on limiting levels of consumption in 
order to reduce risk from contamination.
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    This final rule does not change or supersede any criteria that EPA 
previously promulgated for other states in the NTR, nor does it change 
any other elements of the NTR such as EPA's original basis for 
promulgation. For clarity in organization, EPA is withdrawing 
Washington from the NTR at 40 CFR 131.36 and incorporating the 
Washington-specific criteria in this rule (as well as the existing NTR 
criteria for arsenic, dioxin and thallium) into 40 CFR 131.45 so there 
is a single comprehensive set of federally promulgated criteria for 
Washington.
    This rule applies to waters under the State of Washington's 
jurisdiction, and not to waters within Indian country,\27\ unless 
otherwise specified in federal law. Some waters located within Indian 
country already have CWA-effective human health criteria, while others 
do not.\28\ Several tribes are working with EPA to either revise their 
existing CWA-effective WQS, or obtain treatment in a similar manner as 
a state (TAS) status in order to adopt CWA-effective WQS in the near 
future. EPA will continue to work closely with tribes in Washington to 
ensure that they adopt human health criteria that are scientifically 
supported and protective of designated uses, in accordance with the CWA 
and EPA's regulations. In addition, on September 29, 2016, EPA 
published an Advanced Notice of Proposed Rulemaking in the Federal 
Register that seeks input on an approach that involves EPA promulgating 
baseline WQS for reservations that currently have no CWA-effective WQS, 
including such reservations within the State of Washington.\29\
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    \27\ See 18 U.S.C. 1151 for the definition of Indian country.
    \28\ Indian country waters with CWA-effective WQS include those 
where (a) EPA has authorized a tribe to adopt WQS under the CWA for 
its reservation and the tribe has adopted standards that EPA has 
approved, and (b) EPA has promulgated federal WQS.
    \29\ For more information, see: https://www.epa.gov/wqs-tech/advance-notice-proposed-rulemaking-federal-baseline-water-quality-standards-indian.
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B. Washington's Designated Uses and Tribal Reserved Fishing Rights

a. EPA's Consideration of Tribal Treaty Rights
    Under the Supremacy Clause of the U.S. Constitution, federal 
treaties have the same legal force as federal statutes.\30\ As such, 
the provisions of federal statutes should generally be read in harmony 
with treaties where they both apply. In certain instances, statutes may 
contain provisions indicating that they must be read in harmony with 
treaties. Such is the case with the CWA, which provides that the Act 
``shall not be construed as . . . affecting or impairing the provisions 
of any treaty of the United States.'' \31\
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    \30\ U.S. Const. art. IV, Sec.  2: The ``Constitution . . . of 
the United States . . . and all Treaties made, or which shall be 
made, under the Authority of the United States, shall be the supreme 
Law of the Land; and the Judges in every State shall be bound 
thereby, any Thing in the Constitution or Laws of any State to the 
Contrary notwithstanding.''
    \31\ CWA Section 511, 33 U.S.C. 1371.
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    In determining whether WQS satisfy the CWA and EPA's regulations, 
and when setting criteria for the protection of human health, it is 
necessary to consider other applicable laws, such as federal treaties 
(e.g., U.S. Treaties with Indians). While treaties do not expand EPA's 
authority, they are binding on the federal government. As a result, EPA 
has an obligation to ensure that its actions do not conflict with 
tribal treaty rights.\32\ For the foregoing reasons, and

[[Page 85423]]

as further explained below, it is therefore necessary and appropriate 
to consider tribal treaties to ensure that EPA's actions under the CWA 
are in harmony with such treaties. See also EPA's Response to Comment 
document in the docket for this rule.
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    \32\ U.S. Const. art. IV, Sec.  2; see United States v. Forty-
Three Gallons of Whiskey, 93 U.S. 188, 196 (1833) (recognizing that 
``the Constitution declares a treaty to be the supreme law of the 
land,'' and that ``a treaty is to be regarded . . . as equivalent to 
an act of the legislature'') and Worcester v. Georgia, 31 U.S. 515, 
594 (1832) (``So long as . . . treaties exist, having been formed 
within the sphere of the federal powers, they must be respected and 
enforced by the appropriate organs of the federal government.''). 
See also EPA policies on considering treaty rights: Working 
Effectively With Tribal Governments: Resource Guide at pp. 49-52, 53 
(August 1998) (explaining the key principles underlying the 
application of Indian treaty rights, and noting that ``[f]ederal, 
state, and local agencies need to refrain from taking actions that 
are not consistent with tribal rights wherever they exist''); 
Commemorating the 30th Anniversary of the EPA's Indian Policy, 
Memorandum from Gina McCarthy to All EPA Employees, p. 1 (December 
1, 2014) (reiterating that ``EPA must ensure that its actions do not 
conflict with tribal treaty rights'' and stating that ``EPA programs 
should be implemented to enhance the protection of tribal treaty 
rights and treaty-covered resources when we have the discretion to 
do so''); EPA Policy for the Administration of Environmental 
Programs on Indian Reservations (November 8, 1984) (known as ``EPA 
1984 Indian Policy'').
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b. Treaty-Reserved Subsistence Fishing Rights in Washington
    The majority of waters under the jurisdiction of the State of 
Washington are subject to federal treaties with tribes.\33\ There are 
eight Stevens-Palmer Treaties relevant to the State of Washington 
through which 24 tribes reserved for themselves identical or nearly 
identical fishing rights within the boundaries of present-day 
Washington; specifically, the treaty-reserved ``right of taking fish at 
usual and accustomed places, in common with all citizens of the 
Territory.'' \34\ The right to take fish at usual and accustomed places 
extends to lands formerly ceded by the tribes to the U.S. as described 
in the treaties, as well as to all places beyond the boundaries of the 
ceded territories that tribal members regularly used at treaty 
time.\35\
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    \33\ See https://wdfw.wa.gov/hunting/tribal/treaty_history.html.
    \34\ See e.g. Treaty with the Yakima art. 3, June 9, 1855, 12 
Stat. 951. In United States v. Winans, 198 U.S. 371 (1905), the 
Supreme Court adopted a ``reservation of rights'' approach in 
interpreting the Stevens Treaty with the Yakima Nation: ``the treaty 
was not a grant of rights to the Indians, but a grant of rights from 
them--a reservation of those not granted.'' Id. at 381. In contrast, 
``off reservation fishing by other citizens and residents of the 
state is not a right but merely a privilege which may be granted, 
limited or withdrawn by the state as the interests of the state or 
the exercise of treaty fishing rights may require.'' U.S. v 
Washington, 384 F. Supp. 312, 332 (W.D. Wash. 1974) aff'd 520 F.2d 
676 (9th Cir. 1975), cert. denied 423 U.S. 1086 (1976).
    \35\ See Seufert Bros. Co. v. U.S., 249 U.S. 194, 199 (1919). In 
U.S. v Washington, the court stated, citing Seufert Bros. Co., 
``every fishing location where members of a tribe customarily fished 
from time to time at and before treaty times, however distant from 
the then usual habitat of the tribe, and whether or not other tribes 
then also fished in the same waters, is a usual and accustomed 
ground or station at which the treaty tribe reserved, and its 
members presently have, the right to take fish.'' 384 F. Supp. at 
332.
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    The parties to the treaties all recognized the importance of the 
fishing right for the tribes' subsistence, ceremonial, as well as 
commercial purposes.\36\ In U.S. v Washington, the district court made 
detailed findings of facts regarding the reserved fishing right, 
including the importance of subsistence fishing to the treaty tribes:
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    \36\ For a thorough discussion on the treaty negotiation and 
execution and meaning of the reserved fishing right, see e.g., U.S. 
v Washington, 384 F. Supp. at 348-359 (containing finding of facts 
regarding, inter alia, treaty status, pre-treaty role of fishing 
among northwest Indians, treaty background, negotiation and 
execution of the treaties, and post-treaty Indian fishing); see also 
id. at 340 (``The right to fish for all species available in the 
waters from which, for so many ages, their ancestors derived most of 
their subsistence is the single most highly cherished interest and 
concern of the present members of plaintiff tribes, with rare 
exceptions even among tribal members who personally do not fish or 
derive therefrom any substantial amount of their subsistence.''); 
id. at 343 (``The evidence shows beyond doubt that at treaty time 
the opportunity to take fish for personal subsistence and religious 
ceremonies was the single matter of utmost concern to all treaty 
tribes and their members.''); and U.S. v. Washington, No. 13-35474, 
2016 U.S. App. LEXIS 11709, at *29 (9th Cir. June 27, 2016) (``The 
Indians reasonably understood Governor Stevens to promise not only 
that they would have access to their usual and accustomed fishing 
places, but also that there would be fish sufficient to sustain 
them.'').

    At the treaty negotiations, a primary concern of the tribes, 
whose way of life was so heavily dependent upon harvesting 
anadromous fish, was that they have freedom to move about to gather 
food, particularly salmon, . . . at their usual and accustomed 
fishing places. . . . Subsequent to the execution of the treaties 
and in reliance thereon, the members of the [treaty tribes with 
reserved fishing rights in Washington] have continued to fish for 
subsistence, sport, and commercial purposes at their usual and 
accustomed places. Such fishing provided and still provides an 
important part of their livelihood, subsistence and cultural 
identity. The Indian cultural identification with fishing is 
primarily dietary, related to the subsistence fishery, and 
secondarily associated with religious ceremonies and commercial 
fishing.\37\
---------------------------------------------------------------------------

    \37\ U.S. v Washington, 384 F. Supp. at 355-358 (internal 
citations to exhibits omitted).

    Relevant case law, including Supreme Court precedents, 
unequivocally confirms that the treaty-reserved right to take fish 
includes the right to take fish for subsistence purposes.\38\ 
Historical and current evidence of tribal members' exercise of the 
treaty-reserved subsistence fishing right can be found in heritage FCR 
reports and contemporary FCR surveys (for tables of relevant FCRs, see 
EPA's Response to Comment document in the docket for this rule).
---------------------------------------------------------------------------

    \38\ See e.g., Washington v. Washington State Commercial 
Passenger Fishing Vessel Ass'n, 443 U.S. 658, 678-679 (1979) 
(Because the Indians had always exercised the right to meet their 
subsistence and commercial needs by taking fish from treaty area 
waters, they would be unlikely to perceive a ``reservation'' of that 
right as merely the chance, shared with millions of other citizens, 
occasionally to dip their nets into the territorial waters. 
Moreover, the phrasing of the clause quite clearly avoids placing 
each individual Indian on an equal footing with each individual 
citizen of the State.''); U.S. v. Washington, 2016 U.S. App. LEXIS 
11709 at *28 (Observing that to the Tribes, the Stevens Treaties' 
``principal purpose was to secure a means of supporting themselves 
once the Treaties took effect,'' and to that end, ``[s]almon were a 
central concern.'').
---------------------------------------------------------------------------

    As explained above, the Stevens-Palmer Treaties provide tribes the 
right to exercise subsistence fishing practices on waters throughout 
the State of Washington. EPA concludes that the purpose for which 
tribes reserved such fishing rights through treaties with the U.S. has 
important implications for water quality regulation under the CWA. 
Fundamentally, the tribes' ability to take fish for their subsistence 
purposes under the treaties would be substantially affected or impaired 
if it were not supported by water quality sufficient under the CWA to 
ensure that tribal members can safely eat the fish for their own 
subsistence.
    Many areas where treaty-reserved fishing rights are exercised 
cannot be directly protected or regulated by tribal governments to 
ensure adequate water quality, and therefore the responsibility falls 
to the federal government (and the states) to ensure their protection. 
It is therefore appropriate and necessary for EPA (and states) to 
consider the tribal reserved rights within the framework of the CWA, to 
ensure water quality protection for treaty-reserved subsistence fishing 
rights. EPA's consideration of treaty-reserved fishing rights within 
the framework of the CWA leads to the conclusion, as described below, 
that the human health fishing uses for waters in Washington include 
subsistence fishing, as informed by the tribes' legally protected right 
to continue to take fish for subsistence purposes.\39\
---------------------------------------------------------------------------

    \39\ While EPA's action is based on harmonizing the requirements 
of the CWA with the terms of the treaty-reserved subsistence fishing 
right, the action also is consistent with federal Indian law 
principles addressing subsidiary treaty rights. A written legal 
opinion from the Solicitor of the U.S. Department of Interior (DOI) 
to EPA analyzed whether tribal reserved fishing rights include 
subsidiary rights to sufficient water quality. Letter from Hilary C. 
Tompkins, Solicitor, DOI, to Avi Garbow, General Counsel, EPA, 
regarding Maine's WQS and Tribal Fishing Rights of Maine Tribes 
(January 30, 2015). Although DOI's legal opinion primarily involved 
an analysis of fishing rights of tribes in Maine in connection with 
EPA's February 2, 2015 decision to disapprove WQS applied to waters 
of Indian Lands in Maine, its discussion of tribal fishing rights 
and water quality has relevance to tribes with reserved fishing 
rights in Washington. DOI's legal opinion identified several court 
decisions, including Supreme Court decisions interpreting the 
reserved fishing right in the Stevens Treaties, which have held that 
fishing rights for tribes encompass subsidiary rights that are 
necessary to render those rights meaningful. In Washington v. Wash. 
State Commercial Passenger Fishing Vessel Ass'n, the United States 
Supreme Court held that tribes with reserved fishing rights are 
entitled to something more tangible than ``merely the chance . . . 
occasionally to dip their nets into the territorial seas.'' 443 U.S. 
658, 679 (1979). Consistent with this reasoning, courts have held 
that treaty-reserved fishing rights entail the right to access 
fishing grounds and the right to water quantity sufficient to 
support fish habitat. See e.g., United States v. Winans, 198 U.S. 
371, 384 (1905) (tribe must be allowed to cross private property to 
access traditional fishing ground); Seufert Bros. Co. v. United 
States, 249 U.S. 194 (1919) (tribe entitled to cross over and 
temporarily use any sites which they were accustomed to using at 
treaty time, including sites outside their ceded territories); 
United States v. Adair, 723 F .2d 1394, 1409-10 (9th Cir. 1983) 
(holding that the tribe's fishing right implicitly reserved 
sufficient waters to ``secure to the Tribe a continuation of its 
traditional . . . fishing lifestyle''; Colville Confederated Tribes 
v. Walton, 647 F.2d 42, 47-48 (9th Cir. 1981) (implying reservation 
of water to preserve tribe's replacement fishing grounds). 
Consistent with these precedents, in June 2016 the U.S. Court of 
Appeals for the Ninth Circuit affirmed the district court's finding 
that barrier culverts constructed by the State of Washington 
obstructing fish passage were in violation of tribal fishing rights 
set forth in the Stevens Treaties, noting that ``the Tribes' right 
of access to their usual and accustomed fishing places would be 
worthless without harvestable fish.'' United States v. Washington, 
2016 U.S. App. LEXIS 11709 at *31. The court also acknowledged that 
the fishing clause of the Stevens Treaties could give rise to other 
environmental obligations, but that those would need to be addressed 
on a case-by-case basis depending on the precise nature of the 
action. Id. at *18-19. Consistent with this body of case law, DOI's 
legal opinion concludes that ``fundamental, longstanding tenets of 
federal Indian law support the interpretation of tribal fishing 
rights to include the right to sufficient water quality to 
effectuate the fishing right.'' DOI Letter at 10.

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[[Page 85424]]

c. Use(s) of the Water(s) in Question
    Consistent with EPA's September 14, 2015 proposed rule for 
Washington, in order to effectuate and harmonize treaty-reserved 
fishing rights with the CWA, EPA has determined that such rights must 
be appropriately considered when determining which criteria are 
sufficient to adequately protect Washington's designated uses. Looking 
at the treaty-reserved subsistence fishing right within the CWA water 
quality framework, the first step is to examine the use of the water(s) 
in question. The CWA generally assigns to a state the responsibility of 
determining the designated uses of its waters (subject to certain 
restrictions at 40 CFR 131.10),\40\ and in Washington the state's 
designated uses include fish and shellfish harvesting.\41\ As explained 
above, through treaties, tribes reserved specific fishing rights in 
Washington's waters, including the right to take fish from such waters 
for their subsistence. In order to effectuate these rights in harmony 
with the CWA, EPA has interpreted the state's EPA-approved designated 
fish and shellfish harvesting use to include or encompass a subsistence 
fishing component based on, and consistent with, the rights reserved to 
the tribes through the treaties. As discussed in more detail below, EPA 
construes the CWA to require that, when establishing WQS for these 
waters, the tribal members must be considered the target general 
population for the purposes of setting risk levels to protect the 
subsistence fishing use.
---------------------------------------------------------------------------

    \40\ 33 U.S.C. 1251(a)(2), 1313(c)(2)(A).
    \41\ See WAC 173-201A-600 and WAC 173-201A-610.
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d. Target General Population for Deriving Criteria Protective of the 
Use(s)
    Developing criteria to protect the fish and shellfish harvesting 
use, which includes subsistence fishing as informed by reserved fishing 
rights, necessarily involves identifying tribal members with reserved 
fishing rights as the target population for protection. EPA's 
conclusion to identify tribes as the target population is based on 
EPA's CWA implementing regulations requiring criteria to support the 
most sensitive use (i.e., subsistence fishing) and EPA's 2000 
Methodology recommendation that priority be given to identifying and 
protecting highly exposed populations. Further, in order to derive 
water quality criteria sufficient under the CWA to ensure that the 
tribes' treaty-reserved right to take fish for subsistence purposes is 
not substantially affected or impaired, it is reasonable and 
appropriate to identify tribes as the target general population for 
protection, rather than a subpopulation, and apply the 2000 
Methodology's recommendations on exposure for the general population to 
the tribal target population.
    Per EPA's regulations at 40 CFR 131.11(a)(1), water quality 
criteria must contain sufficient parameters or constituents to protect 
the designated use, and for waters with multiple uses, the criteria 
must support the most sensitive use. In the case of Washington's human 
health-related uses, the most sensitive use is fish and shellfish 
harvesting, which, as explained above, EPA has interpreted to include 
or encompass a subsistence fishing component based on, and consistent 
with, the rights reserved to the tribes through the treaties. 
Developing water quality criteria to protect the subsistence fishing 
component of the fish or shellfish harvesting use necessarily involves 
identifying the population exercising that use.
    EPA's decision to identify tribes as the target population is 
further supported by EPA guidance for developing water quality criteria 
to protect human health. As explained in EPA's 2000 Methodology, the 
choice of the particular population to protect is an important decision 
to make when setting human health criteria.\42\ EPA recommends that 
states provide adequate protection from adverse health effects to the 
general population, as well as to highly exposed populations, such as 
recreational and subsistence fishers, two distinct groups with FCRs 
that may be greater than the general population.\43\ In fact, EPA's 
2000 Methodology recommends considering how to protect both susceptible 
and highly exposed populations when setting criteria:
---------------------------------------------------------------------------

    \42\ EPA's 2000 Methodology, 2-1.
    \43\ Id. at 2-2.

    EPA recommends that priority be given to identifying and 
adequately protecting the most highly exposed population. Thus, if 
the State or Tribe determines that a highly exposed population is at 
greater risk and would not be adequately protected by criteria based 
on the general population, and by the national 304(a) criteria in 
particular, EPA recommends that the State or Tribe adopt more 
stringent criteria using alternative exposure assumptions.\44\
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    \44\ EPA's 2000 Methodology, 2-1--2. See also EPA's 2000 
Methodology, 4-17 (``When choosing exposure factor values to include 
in the derivation of a criterion for a given pollutant, EPA 
recommends considering values that are relevant to population(s) 
that is (are) most susceptible to that pollutant. In addition, 
highly exposed populations should be considered when setting 
criteria.'').

Therefore, consistent with the guidance, EPA identifies the tribal 
population as the target population for protection and the subsistence 
fishing use must be the focus of the risk assessment supporting water 
quality criteria to adequately protect that use. Deriving criteria 
protective of the tribal target population necessarily involves 
determining the appropriate inputs for calculating protective criteria 
---------------------------------------------------------------------------
for tribal subsistence fishers, such as the FCR and cancer risk level.

    EPA's approach in the 2000 Methodology, and its approach used for 
deriving national 304(a) recommended criteria, is for human health 
water quality criteria to provide a high level of protection for the 
general population (for example, FCRs designed to represent ``the 
general population of fish consumers,'' or a cancer risk level that 
``reflects an appropriate risk for the general population''), while 
recognizing that more highly exposed ``subpopulations'' may face 
greater levels of risk.\45\ The 2000 Methodology does not, however, 
speak to or envision the unique situation of setting WQS that cover 
areas where tribes have treaty-reserved rights to practice subsistence

[[Page 85425]]

fishing.\46\ Nevertheless, it is possible to apply the general 
principles outlined in the 2000 Methodology to this situation, as 
informed by the treaties.
---------------------------------------------------------------------------

    \45\ See EPA's 2000 Methodology, 2-6--7, 4-24--25.
    \46\ In response to comments on EPA's 1998 draft Human Health 
Methodology revisions, the Agency responded: ``As stated in the 1998 
draft Methodology revisions, `risk levels and criteria need to be 
protective of tribal rights under federal law (e.g., fishing, 
hunting, or gathering rights) that are related to water quality.' We 
believe the best way to ensure that Tribal treaty and other rights 
under Federal law are met, consistent with the Federal trust 
responsibility, is to address these issues at the time EPA reviews 
water quality standards submissions.'' (See 65 FR 66444, 66457 
November 3, 2000).
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    In light of the presence of the treaty-reserved fishing rights in 
Washington, interpreted by the U.S. Supreme Court to encompass, among 
other things, subsistence fishing, and EPA's interpretation of 
Washington's fish and shellfish harvesting use to include subsistence 
fishing, it is reasonable and appropriate to require that tribes with 
such rights be considered as the target general population for deriving 
criteria protective of the use rather than a sensitive subpopulation 
within the overall population of Washington. Treating tribes as the 
target general population will help derive water quality criteria 
sufficient under the CWA to ensure that the tribes' treaty-reserved 
right to take fish for subsistence purposes is not substantially 
affected or impaired. Therefore, the 2000 Methodology's recommendations 
on exposure for the target general population can be applied 
accordingly. EPA's conclusion to treat tribes as the target general 
population, as opposed to a subpopulation, is further supported by 
relevant case law interpreting the treaty-reserved fishing rights 
applicable in Washington; specifically the phrase ``in common with all 
citizens of the territory.''
    Treating tribes as the target population instead of a sensitive 
subpopulation also impacts another important input parameter used to 
derive human health criteria, the cancer risk level. For carcinogenic 
pollutants, EPA's 2000 Methodology recommends that states protect the 
general population to a level of incremental cancer risk no greater 
than one in one hundred thousand to one in one million (1 x 
10-5 to 10-6). For over 20 years, Washington has 
used 10-6 as the level of risk that must be used to 
establish human health criteria for carcinogenic pollutants. EPA's 2000 
Methodology indicates that if there are highly exposed groups or 
subpopulations within that target general population, such as 
subsistence consumers, WQS should protect those consumers to a level of 
incremental risk no greater than one in ten thousand (1 x 
10-4).\47\ However, where treaty-reserved tribal fishing 
rights apply to particular waters, it would be unreasonable to expose 
the communities exercising those rights to levels of risk above what 
would be reasonable for the general population of the state. See 
section III.C.b for more information on cancer risk level.
---------------------------------------------------------------------------

    \47\ 2000 Methodology, 2-6.
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e. Water Quality Criteria Sufficient To Protect the Use(s)
    The data used to determine the FCR are critical to deriving 
criteria that will protect the subsistence fishing portion of the fish 
and shellfish harvesting designated use. EPA provides a recommended 
national default FCR for the general population but strongly recommends 
the use of local or regional data, where available, over default 
values.\48\ Further, as EPA explained in its January 2013 Human Health 
Ambient Water Quality Criteria and Fish Consumption Rates: Frequently 
Asked Questions, it is important to avoid selecting a FCR that reflects 
consumption that is suppressed due to concerns about the safety of 
available fish. Under certain circumstances, it may also be relevant to 
look at the availability of fish when considering suppression effects 
on current FCRs.\49\ EPA maintains that it is important, as a CWA goal, 
to avoid the suppression effect that may occur when criteria are 
derived using a FCR for a given target population that reflects an 
artificially diminished level of fish consumption from an appropriate 
baseline level of consumption for that population.\50\ To use a FCR 
that is suppressed would not result in criteria that actually protect a 
fishing use because it would merely reinforce the existing suppressed 
use, or worse, set in motion a ``downward spiral'' \51\ of further 
reduction/suppression of fish consumption due to concerns about the 
safety of available fish or depleted fisheries. The CWA is meant not 
merely to maintain the status quo, but to restore and maintain the 
chemical, physical, and biological integrity of the Nation's waters. 
Therefore, deriving criteria using an unsuppressed FCR furthers the 
restoration goals of the CWA and ensures protection of human health-
related designated uses (as pollutant levels decrease, fish habitats 
are restored, and fish availability increases over time).
---------------------------------------------------------------------------

    \48\ EPA's 2000 Methodology, 4-24--4-25 (``EPA's first 
preference is that States and authorized Tribes use the results from 
fish intake surveys of local watersheds within the State or Tribal 
jurisdiction to establish fish intake rates that are representative 
of the defined populations being addressed for the particular 
waterbody.'')
    \49\ As noted by the National Environmental Justice Advisory 
Council in the 2002 publication Fish Consumption and Environmental 
Justice, ``a suppression effect may arise when fish upon which 
humans rely are no longer available in historical quantities (and 
kinds), such that humans are unable to catch and consume as much 
fish as they had or would. Such depleted fisheries may result from a 
variety of affronts, including an aquatic environment that is 
contaminated, altered (due, among other things, to the presence of 
dams), overdrawn, and/or overfished. Were the fish not depleted, 
these people would consume fish at more robust baseline levels. . . 
. In the Pacific Northwest, for example, compromised aquatic 
ecosystems mean that fish are no longer available for tribal members 
to take, as they are entitled to do in exercise of their treaty 
rights.''). National Environmental Justice Advisory Council, Fish 
Consumption and Environmental Justice, p.44, 46 (2002) available at 
https://www.epa.gov/sites/production/files/2015-02/documents/fish-consump-report_1102.pdf.
    \50\ See id. at 43.
    \51\ See id. at 47.
---------------------------------------------------------------------------

    CWA section 303(c)(2)(A) requires that water quality criteria be 
``based upon'' applicable designated uses, and that such uses and 
criteria ``shall be such as to protect the public health or welfare, 
enhance the quality of water and serve the purposes of this [Act].'' 
The ``purposes of this [Act]'' are in section 101, and include, among 
other things, ``to restore and maintain the chemical, physical, and 
biological integrity of the Nation's waters'' and ``water quality which 
provides for the protection and propagation of fish, shellfish, and 
wildlife and provides for recreation in and on the water.'' EPA's 
implementing water quality regulations at 40 CFR 131.11 require water 
quality criteria to be based on sound scientific rationale and 
sufficient to protect the designated use, regardless of whether that 
use is currently being met. A subsistence fishing designated use, by 
definition, represents a level of fish consumption that is adequate to 
provide subsistence, regardless of whether such consumption is 
occurring today. It is entirely consistent with the CWA and regulations 
for EPA to determine that to protect the designated use, it is 
necessary and appropriate to derive the human health criteria using a 
fish consumption rate that reflects a subsistence level of consumption 
that is not artificially suppressed as a result of concerns about 
pollution or fish contamination where such data are available.
    Any fish consumption rate used in setting criteria to protect a 
subsistence fishing use must allow for the consumption of fish from 
local waters at levels that could sustain and be protective of members 
of the target population practicing a subsistence lifestyle. Water 
quality criteria derived

[[Page 85426]]

using a FCR below a level that would be adequate to sustain members of 
the target population exercising a subsistence use, such as tribal 
members who have a history of subsistence fishing in Washington, would 
not be protective of that use. In this context, use of an unsuppressed 
rate, where data to determine that rate are available, would ensure 
that the resulting criteria are protective of the subsistence use.
    The importance of relying on an unsuppressed FCR, where data are 
available, is especially evident where the subsistence use is based in 
whole or in part on tribal treaty and other reserved subsistence 
fishing rights. This is because if human health criteria are set at a 
level that assumes only suppressed fish consumption, the waters will 
only be protected to support that level of suppressed fish consumption 
and thus never fully support--and potentially even may directly 
impair--the tribes' legal right to take fish for subsistence purposes. 
Accordingly, where adequate data are available to clearly demonstrate 
what the current unsuppressed FCR is for the relevant target 
population, the selected FCR must reflect that value. In the absence of 
such data, states, tribes, and EPA could consider upper percentile FCRs 
of local contemporary fish consumption surveys (such as the 95th or 
99th percentile), heritage FCR data for the target population, and/or 
FCRs that provide for a subsistence fishing lifestyle. Consultation 
with tribes is important to ensure that all data and information 
relevant to this issue are considered.
    Although treaties do not cover all waters in Washington, they cover 
the vast majority of the state's waters. Additionally, where treaty and 
non-treaty reserved rights apply on waters downstream of waters without 
reserved fishing rights, upstream WQS must provide for the attainment 
and maintenance of downstream WQS in accordance with EPA's regulations 
at 40 CFR 131.10(b). Based on a GIS analysis included in the docket for 
this final rulemaking, EPA concluded that greater than 90 percent of 
waters in Washington are covered by treaty rights and/or are upstream 
of waters with such rights or waters in Oregon (see section III.C.a). 
For any remaining waters in Washington, where reserved rights do not 
apply and that are not upstream of waters with such rights or waters in 
Oregon, it would be administratively burdensome to develop separate 
criteria to apply to such a small subset of waters, and would be 
difficult to implement separate criteria with a patchwork of protection 
among these areas when administering the WQS, NPDES permitting, and 
other programs. Therefore, EPA applies these final criteria to all 
waters under Washington's jurisdiction.
    Many commenters supported EPA's decisions to derive criteria 
protective of the tribal population exercising their treaty-reserved 
fishing rights in Washington as the target general population, and to 
apply the resulting criteria to all waters under Washington's 
jurisdiction. Many other commenters did not support these decisions, 
and argued that EPA did not have a scientific or legal basis to 
interpret Washington's designated uses to encompass subsistence fishing 
and to treat the tribal population with treaty-reserved fishing rights 
as the target general population for protection under such use. For 
additional responses to these comments, see EPA's Response to Comment 
document in the docket for this rule.

C. Washington-Specific Human Health Criteria Inputs

a. Fish Consumption Rate
    In Washington there are 24 tribes with treaty-reserved fishing 
rights, rights that encompass the right to fish for subsistence 
purposes, and several local and regional FCR surveys and heritage 
tribal consumption reports with widely varying estimates of tribal FCRs 
in Washington (for tables of relevant FCRs, see EPA's Response to 
Comment document in the docket for this rule). Available heritage FCRs 
range from 401 to 995 g/day, and contemporary survey FCRs range from 63 
to 214 g/day (mean FCRs) and from 113 to 489 g/day (90th percentile 
FCRs). The discrepancy between contemporary and heritage FCRs suggests 
that current FCRs for certain tribal consumers in Washington may be 
suppressed.52 53 It is currently unclear how a contemporary 
fish consumption survey might quantitatively account for suppression, 
resulting in estimates of current FCRs that are unsuppressed to the 
maximum degree practicable. There is no local survey of contemporary 
fish consumption in Washington adjusted specifically to account for 
suppression, and no survey is a clear representation of current 
unsuppressed consumption for all tribes in Washington. Consistent with 
the principles outlined above, EPA considered the available, 
scientifically sound fish consumption data for Washington tribes and 
consulted with tribal governments to select a FCR for this final 
rulemaking.
---------------------------------------------------------------------------

    \52\ The number of fish advisories and closures due to 
contamination also suggest that contemporary FCRs may be suppressed 
due to concerns about pollution. See Washington Department of 
Health, Fish Consumption Advisories, available at https://www.doh.wa.gov/CommunityandEnvironment/Food/Fish/Advisories.
    \53\ Heritage rates refer to the rates of fish intake consistent 
with traditional tribal practices, prior to contact with European 
settlers.
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    The Washington tribes have generally agreed that 175 g/day is 
acceptable for deriving protective criteria at this time, when 
accompanied by other protective input parameters to calculate the 
criteria. However, EPA recognizes that some tribes have raised concerns 
as to whether a FCR of 175 g/day reasonably reflects current 
unsuppressed consumption rates of tribes within the State of 
Washington, based on the best currently available information. A FCR of 
175 g/day approximates the 95th percentile consumption rate of surveyed 
tribal members from the CRITFC study \54\ and includes anadromous fish, 
which is reasonable given that these marine species reside in 
Washington's nearshore (i.e., within three miles of the coast) waters, 
especially Puget Sound, and accumulate pollutants discharged to these 
waters during a significant portion of their lives. The CRITFC survey 
also includes four tribes (three of which have treaty-reserved rights 
in Washington, the most of any one contemporary FCR survey in 
Washington) along the Columbia River in Washington, Idaho, and Oregon. 
Given this, and also considering the variability in heritage and 
contemporary FCRs and the uncertainty regarding suppression effects on 
current FCRs, the CRITFC survey provides scientifically sound estimates 
of fish consumption for the purpose of deriving a Washington statewide 
FCR for the tribal target general population.
---------------------------------------------------------------------------

    \54\ Fish Consumption Survey of the Umatilla, Nez Perce, Yakama, 
and Warm Springs Tribes of the Columbia River Basin (Columbia River 
Inter-Tribal Fish Commission (CRITFC), 1994).
---------------------------------------------------------------------------

    Additionally, Oregon, much of which is downstream from Washington 
(or cross-stream in the Columbia River where it forms the border 
between the two states), used a FCR of 175 g/day to derive statewide 
human health criteria, which EPA approved in 2011. Use of this FCR to 
derive Washington's criteria will thus help ensure the attainment and 
maintenance of downstream WQS in Oregon.
    Many commenters supported EPA's selected FCR, as well as the 
Agency's position that it is important to consider suppression effects 
on the FCR in general, and necessary and appropriate to do so where 
subsistence fishing is a reserved right and encompassed by the 
designated use of the waters. Some

[[Page 85427]]

commenters expressed concern that 175 g/day was not high enough to 
reflect current or historical consumption rates of all tribes in 
Washington. Many other commenters expressed the opposite concern, that 
175 g/day was unreasonably high in order to protect Washington 
residents, and argued that treaty-reserved rights do not confer the 
right to eat fish at unsuppressed levels. Some of those commenters also 
argued that the CWA does not mention suppression. For detailed 
responses to these comments, see EPA's Response to Comment document in 
the docket for this rule.
b. Cancer Risk Level
    EPA derives final human health criteria for carcinogens in 
Washington using a cancer risk level of one in one million 
(10-6), based on Washington's longstanding use of that 
cancer risk level, EPA guidance, tribal reserved fishing rights, and 
downstream protection requirements.
    To derive final human health criteria for each state in the NTR, 
EPA selected a cancer risk level based on each state's policy or 
practice regarding what risk level should be used when regulating 
carcinogens in surface waters. In its official comments on EPA's 
proposed NTR in 1992, Washington asked EPA to promulgate human health 
criteria using a cancer risk level of 10-6, stating, ``The 
State of Washington supports adoption of a risk level of one in one 
million for carcinogens. If EPA decides to promulgate a risk level 
below one in one million, the rule should specifically address the 
issue of multiple contaminants so as to better control overall site 
risks.'' (57 FR 60848, December 22, 1992). Accordingly, in the NTR, EPA 
used a cancer risk level of 10-6 (one in one million) to 
derive human health criteria for Washington. Subsequently, Washington 
adopted and EPA approved a provision in the state's WQS that reads: 
``Risk-based criteria for carcinogenic substances shall be selected 
such that the upper-bound excess cancer risk is less than or equal to 
one in a million'' (WAC 173-201A-240(6)). In Washington's August 1, 
2016 submittal, the cancer risk level is identified in the new text and 
reformatted toxics criteria table at WAC 173-201A-240.
    Subsequent to promulgating the NTR, EPA issued its 2000 
Methodology, which states that when promulgating water quality criteria 
for states and tribes, EPA intends to use the 10-6 cancer 
risk level, which reflects an appropriate risk for the general 
population.\55\ In this action, as described above, tribes with treaty-
reserved rights in Washington are the target general population for the 
purpose of deriving revised criteria to protect the subsistence fishing 
uses of Washington's waters. Because those tribes are the general 
population in this case, EPA's selection of a 10-6 cancer 
risk level for the tribal target general population is consistent with 
current EPA guidance, specifically the 2000 Methodology.
---------------------------------------------------------------------------

    \55\ EPA's 2000 Methodology, pages 2-6.
---------------------------------------------------------------------------

    In addition, use of a cancer risk rate of 10-6 ensures 
that the resulting human health criteria for carcinogens protect the 
subsistence fishing component of the designated use. Due to uncertainty 
regarding suppression effects (see sections II.C, III.B, and III.C.a, 
and EPA's Response to Comment document in the docket for this rule), 
using a cancer risk level of 10-6 along with a FCR of 175 g/
day ensures that tribal members with treaty-reserved fishing rights 
will be protected at an acceptable risk level for the target general 
population. Throughout tribal consultation, the tribes generally 
supported 175 g/day as an acceptable FCR for purposes of revising 
Washington's human health criteria at this time, when accompanied by 
other protective input parameters (e.g., a cancer risk level of 
10-6), to account for the uncertainty around an appropriate 
FCR value reflective of tribal subsistence fishing.
    Finally, as discussed in section III.C.a, many of Washington's 
rivers are in the Columbia River Basin, upstream of Oregon's portion of 
the Columbia River. Oregon's criteria are based on a FCR of 175 g/day 
and a cancer risk level of 10-6. EPA's decision to derive 
human health criteria for Washington using a cancer risk level of 
10-6 along with a FCR of 175 g/day helps ensure that 
Washington's criteria will ensure the attainment and maintenance of 
Oregon's downstream WQS as required by 40 CFR 131.10(b).
    Many commenters supported EPA's selection of a 10-6 
cancer risk level, and EPA's rationale for doing so. Many other 
commenters disagreed and argued that deriving human health criteria for 
Washington using a 10-5 cancer risk level is appropriate and 
consistent with EPA guidance and past practice. Many of these 
commenters stated that tribal treaties did not confer rights to a 
particular level of risk. Additionally, some commenters supported EPA's 
consideration of downstream WQS in Oregon when establishing the 
criteria upstream, while others expressed concern that EPA was 
suggesting that Washington's upstream criteria must be identical to 
Oregon's downstream criteria and in doing so, acting inconsistently 
with its 2014 Frequently Asked Questions document on downstream 
protection.\56\ For detailed responses to these comments, see EPA's 
Response to Comment document in the docket for this rule.
---------------------------------------------------------------------------

    \56\ https://nepis.epa.gov/Exe/ZyPDF.cgi/P100LIJF.PDF?Dockey=P100LIJF.PDF.
---------------------------------------------------------------------------

c. Relative Source Contribution
    EPA recommends using a RSC for non-carcinogens and nonlinear 
carcinogens to account for sources of exposure other than drinking 
water and consumption of inland and nearshore fish and shellfish (see 
section II.C.d). In 2015, after evaluating information on chemical 
uses, properties, occurrences, releases to the environment and 
regulatory restrictions, EPA developed chemical-specific RSCs for non-
carcinogens and nonlinear carcinogens ranging from 0.2 (20 percent) to 
0.8 (80 percent) following the Exposure Decision Tree approach 
described in EPA's 2000 Methodology.57 58 EPA proposed to 
use these same RSCs to derive human health criteria for Washington, and 
where EPA did not update the nationally recommended criteria for 
certain pollutants in 2015, EPA proposed to use a RSC of 0.2 to derive 
human health criteria for those pollutants in Washington to ensure 
protectiveness.
---------------------------------------------------------------------------

    \57\ USEPA. 2000. Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC EPA-822-B-00-004. 
https://www.epa.gov/wqc/human-health-water-quality-criteria.
    \58\ Final Updated Ambient Water Quality Criteria for the 
Protection of Human Health, (80 FR 36986, June 29, 2015). See also: 
USEPA. 2015. Final 2015 Updated National Recommended Human Health 
Criteria. U.S. Environmental Protection Agency, Office of Water, 
Washington, DC https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------

    Several commenters supported EPA's use of RSCs to account for other 
sources of pollutant exposure. Several others disagreed, arguing that 
water quality criteria under the CWA cannot control or consider sources 
of exposure other than from drinking water and eating fish and 
shellfish, so human health criteria should not account for these 
sources. Many of the commenters, in addition to criticizing the concept 
of RSCs as overly-conservative, argued that EPA was double-counting 
exposure to anadromous fish (which EPA considers marine in the national 
dataset) by both including them in the FCR and using the pollutant-
specific RSCs that EPA pairs with an inland and nearshore-only

[[Page 85428]]

FCR in its 304(a) national recommended human health criteria. 
Commenters argued that this is inconsistent with EPA's guidance, which 
recommends that states adjust the RSC to reflect a greater proportion 
of the RfD being attributed to water, fish and shellfish intake in 
instances where the FCR includes freshwater, estuarine and all marine 
fish consumption.\59\ For detailed responses to the comments, see EPA's 
Response to Comment document in the docket for this rule.
---------------------------------------------------------------------------

    \59\ USEPA. January 2013. Human Health Ambient Water Quality 
Criteria and Fish Consumption Rates: Frequently Asked Questions. 
https://www.epa.gov/wqc/human-health-ambient-water-quality-criteria-and-fish-consumption-rates-frequently-asked.
---------------------------------------------------------------------------

    Additionally, after further evaluation of the proposed revised 
human health criteria for antimony, EPA determined that the existing 
304(a) national recommended criteria for antimony (last updated in 
2002) use a pollutant-specific RSC of 0.4. EPA intended to apply a 0.2 
RSC as a protective approach only where pollutant-specific RSCs were 
not already developed, which is not the case for antimony.\60\
---------------------------------------------------------------------------

    \60\ https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=20003IEI.txt See 
also: National Primary Drinking Water Regulations-Synthetic Organic 
Chemicals and Inorganic Chemicals; National Primary Drinking Water 
Regulations Implementation, 57 FR 31776, July 17, 1992.
---------------------------------------------------------------------------

    While the selected FCR of 175 g/day does not include all marine 
fish (e.g., it does not include consumption of species such as 
swordfish, tuna, etc.), EPA acknowledges that the criteria as proposed 
may have double-counted potential exposure to some pollutants in 
certain marine fish that are anadromous (e.g., salmon). Therefore, EPA 
reviewed the RSCs in the proposed rule in light of EPA's guidance, 
which includes both the Exposure Decision Tree and associated 
discussion in EPA's 2000 Methodology, as well as EPA's recommendation 
to adjust the RSC when the FCR includes freshwater, estuarine, and all 
marine fish consumption. Arguably, EPA's guidance does not consider 
this exact scenario where the selected FCR includes some, but not all, 
species that EPA classifies as marine in the national NHANES dataset 
(and excludes some species that EPA classifies as nearshore in the 
national NHANES dataset, i.e., shellfish).
    One way to adjust the RSC values to account for inclusion of marine 
fish in the FCR is to examine the ratio of the national data 
characterizing all fish consumption rates versus inland and nearshore-
only fish consumption rates derived from the NHANES dataset, and apply 
this ratio to the proportion of the RfD reserved for inland and 
nearshore fish consumption in the RSC. This approach assumes that the 
pollutant concentrations in anadromous fish are the same as the 
pollutant concentrations in inland and nearshore fish, which is the 
same assumption inherent in including multiple fish categories in the 
FCR for criteria calculation. This approach further assumes that the 
ratio of all fish to inland and nearshore fish from NHANES data 
approximates the ratio of inland, nearshore, and anadromous fish to 
just inland and nearshore fish from CRITFC data. At the 90th percentile 
rate of consumption, the national adult consumption rate from NHANES 
data for all fish is 53 g/day and 22 g/day for inland and nearshore-
only fish, or a ratio of 2.4. Applying this to a RSC of 0.2 yields 
0.48, or 0.5 rounding to a single decimal place. Because the selected 
FCR includes some but not all marine species, EPA decided to use this 
approach to adjust the RSC values. However, EPA only adjusted RSC 
values to 0.5 for criteria calculations previously using a RSC between 
0.2 and 0.5.
    There are important considerations in assigning a RSC, such as the 
total number of potential exposure routes from sources other than fish 
consumption, which compels caution in using this approach in all cases. 
As such, EPA decided to retain RSC values of 0.5 and above, recognizing 
the compelling need to account for the other potential exposure 
sources, including marine fish not accounted for in the FCR of 175 g/
day, consistent with the logic and procedures used in establishing the 
national 304(a) criteria recommendations. The Exposure Decision Tree in 
EPA's 2000 Methodology only recommends using a RSC above 0.5 when there 
are no significant known or potential uses/sources other than the 
source of concern (Box 7, Figure 4-1 in EPA's 2000 Methodology) or 
there are sufficient data available on each source to characterize the 
exposure to those sources (Box 8C, Figure 4-1). Neither of these 
conditions are met for most of the pollutants in the final rule for 
Washington. EPA is not adjusting the RSCs for pollutants that already 
have national recommended RSCs greater than or equal to 0.5 (2-
Chloronaphthalene (0.8), Endrin (0.8), gamma-BHC/Lindane (0.5), and 
methylmercury (2.7 x 10-5 subtracted from the RfD, which 
equates to a RSC of approximately 0.73). See Table 1, column B2 for a 
list of EPA's final RSCs by pollutant.
d. Body Weight
    EPA calculates final human health criteria for Washington using a 
body weight of 80 kg, which represents the average weight of a U.S. 
adult and is consistent with EPA's 2015 updated national default body 
weight (see section II.C.c).\61\ Local tribal survey data relevant to 
Washington are also consistent with EPA's national adult body weight of 
80 kg.\62\ Most commenters were silent on EPA's proposal to use a body 
weight of 80 kg to calculate human health criteria for Washington. A 
few commenters were concerned that 80 kg would not ensure adequate 
protection of women and children, and may not be representative of all 
residents in Washington based on limited local or regional data on body 
weight specific to Washington residents. EPA understands these 
concerns, but decided that the survey on which EPA's national default 
of 80 kg is based provides the most comprehensive dataset to establish 
a body weight value for deriving statewide human health criteria for 
Washington, and is consistent with the local tribal survey data 
mentioned above. The data cited by commenters do not provide sufficient 
evidence to come up with an alternative statewide body weight input 
parameter since the studies cited are limited in scope and pertain to 
specific subpopulations. For detailed responses to the comments, see 
EPA's Response to Comment document in the docket for this rule.
---------------------------------------------------------------------------

    \61\ Final Updated Ambient Water Quality Criteria for the 
Protection of Human Health, (80 FR 36986, June 29, 2015). See also: 
USEPA. 2015. Final 2015 Updated National Recommended Human Health 
Criteria. U.S. Environmental Protection Agency, Office of Water, 
Washington, DC https://www.epa.gov/wqc/human-health-water-quality-criteria.
    \62\ USEPA Region 10. August 2007. Framework for Selecting and 
Using Tribal Fish and Shellfish Consumption Rates for Risk-Based 
Decision Making at CERCLA and RCRA Cleanup Sites in Puget Sound and 
the Strait of Georgia. Appendix B. https://yosemite.epa.gov/r10/
CLEANUP.NSF/7780249be8f251538825650f0070bd8b/
e12918970debc8e488256da6005c428e/$FILE/
Tribal%20Shellfish%20Framework.pdf.
---------------------------------------------------------------------------

e. Drinking Water Intake
    EPA calculates final human health criteria for Washington using a 
drinking water intake rate of 2.4 L/day, consistent with EPA's 2015 
updated national default drinking water intake rate (see section 
II.C.c).\63\ Most commenters were

[[Page 85429]]

silent on or agreed with EPA's proposal to use a drinking water intake 
rate of 2.4 L/day to calculate human health criteria for Washington. 
However, two commenters stated this input was unnecessary in human 
health criteria derivation. Since at least the 1980s, EPA has included 
the drinking water exposure pathway in the development of human health 
criteria in order to protect water bodies with a drinking water 
designated use. EPA also provides the option of using organism-only 
human health criteria for water bodies where there is no drinking water 
use. One commenter stated that 2.4 L/day was an underestimate, and 
expressed concern that this value is not protective of tribal members 
who consume more water. EPA determined that it is appropriate to use 
its 2015 final national default drinking water intake rate, since it 
was adjusted pursuant to public comments after EPA issued the draft 
national default rate of 3 L/day in 2014. EPA acknowledges the concerns 
about members of the target general population who may consume larger 
amounts of water, but EPA does not have data (and did not receive any 
during the public comment period) with which to calculate a Washington-
specific drinking water intake rate. For detailed responses to the 
comments, see EPA's Response to Comment document in the docket for this 
rule.
---------------------------------------------------------------------------

    \63\ Final Updated Ambient Water Quality Criteria for the 
Protection of Human Health, (80 FR 36986, June 29, 2015). See also: 
USEPA. 2015. Final 2015 Updated National Recommended Human Health 
Criteria. U.S. Environmental Protection Agency, Office of Water, 
Washington, DC https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------

f. Pollutant-Specific Reference Doses and Cancer Slope Factors
    As part of EPA's 2015 updates to its 304(a) recommended human 
health criteria, EPA conducted a systematic search of eight peer-
reviewed, publicly available sources to obtain the most current 
toxicity values for each pollutant (RfDs for non-carcinogenic effects 
and CSFs for carcinogenic effects).\64\ EPA calculates final human 
health criteria for Washington using the same toxicity values that EPA 
used in its 2015 304(a) criteria updates, to ensure that the resulting 
criteria are based on a sound scientific rationale. Where EPA did not 
update criteria for certain pollutants in 2015 and those pollutants are 
included in this final rule, EPA uses the toxicity values that the 
Agency used the last time it updated its 304(a) criteria for those 
pollutants as the best available scientific information. See Table 1, 
columns B1 and B3 for a list of EPA's final toxicity factors by 
pollutant.
---------------------------------------------------------------------------

    \64\ Final Updated Ambient Water Quality Criteria for the 
Protection of Human Health, (80 FR 36986, June 29, 2015). See also: 
USEPA. 2015. Final 2015 Updated National Recommended Human Health 
Criteria. U.S. Environmental Protection Agency, Office of Water, 
Washington, DC https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------

    In general, commenters were supportive of EPA using the latest and 
most scientifically defensible toxicity values to derive human health 
criteria for Washington. Some commenters expressed concern that where 
EPA did not update its 304(a) national recommended human health 
criteria for particular pollutants in 2015, the toxicity values from 
the existing 304(a) criteria for those pollutants were no longer valid. 
In particular, those commenters expressed concern about the CSFs for 
arsenic and PCBs, and the RfD for methylmercury, and argued that EPA 
should not revise Washington's criteria for those pollutants until 
toxicity factors are updated in the future. Unlike the situation with 
the toxicity factors for arsenic, dioxin and thallium (see section 
III.A), there is not sufficient scientific uncertainty surrounding the 
CSF for PCBs or the RfD for methylmercury to warrant delaying revision 
to Washington's human health criteria for these pollutants. For 
detailed responses to the comments, see EPA's Response to Comment 
document in the docket for this rule.
g. Pollutant-Specific Bioaccumulation Factors
    For the 2015 national 304(a) human health criteria update, EPA 
estimated chemical-specific BAFs using a framework for deriving 
national BAFs described in EPA's 2000 Methodology.\65\ Because the 
surveyed population upon which the 175 g/day FCR is based consumed 
almost exclusively trophic level four fish (i.e., predator fish 
species), EPA uses the trophic level four BAF from the 2015 304(a) 
human health criteria updates in conjunction with the 175 g/day FCR, in 
order to derive protective criteria.\66\ Where in 2015, EPA estimated 
BAFs from laboratory-measured BCFs and therefore derived a single 
pollutant-specific BAF for all trophic levels, EPA uses those single 
BAFs from the 2015 304(a) human health criteria updates. Where EPA's 
existing 304(a) recommended human health criteria for certain 
pollutants still incorporate a BCF, and those pollutants are included 
in this final rule, EPA uses those BCFs as the best available 
scientific information. See Table 1, columns B4 and B5 for a list of 
EPA's final bioaccumulation factors by pollutant.
---------------------------------------------------------------------------

    \65\ USEPA. 2000. Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC EPA-822-B-00-004. 
https://www.epa.gov/wqc/human-health-water-quality-criteria.
    \66\ Fish Consumption Survey of the Umatilla, Nez Perce, Yakama, 
and Warm Springs Tribes of the Columbia River Basin (Columbia River 
Inter-Tribal Fish Commission (CRITFC), 1994)
---------------------------------------------------------------------------

    Many commenters supported EPA's choice to use the latest and most 
scientifically defensible BAFs to derive human health criteria for 
Washington, and to use BCFs only when BAFs were not available for a 
given pollutant. Other commenters asserted that BCFs are no less 
scientifically defensible than BAFs, and that EPA did not provide 
sufficient information regarding how it developed BAFs in 2015 for 
commenters to fully evaluate EPA's proposed approach.
    EPA's 2000 Methodology recommends use of BAFs that account for 
uptake of a contaminant from all sources by fish and shellfish, rather 
than BCFs that only account for uptake from the water column. EPA's 
2015 national recommended BAFs are based on peer-reviewed, publicly 
available data and were developed consistent with EPA's 2000 
Methodology and its supporting documents. EPA provided the basis for 
its 2015 BAFs in individual pollutant-specific criteria documents. The 
final human health criteria for Washington are consistent with EPA's 
2000 Methodology, which makes clear that BAFs are a more scientifically 
defensible representation of bioaccumulation than BCFs. For detailed 
responses to the comments, see EPA's Response to Comment document in 
the docket for this rule.

D. Final Human Health Criteria for Washington

    EPA finalizes 144 human health criteria for 74 different pollutants 
(72 organism-only criteria and 72 water-plus-organism criteria) to 
protect the applicable designated uses of Washington's waters (see 
Table 1). The water-plus-organism criteria in column C1 and the 
methylmercury criterion in column C2 of Table 1 are the applicable 
criteria for any waters that include the Domestic Water (domestic water 
supply) use defined in Washington's WQS (WAC 173-201A-600). The 
organism-only criteria in column C2 of Table 1 apply to waters that do 
not include the Domestic Water (domestic water supply) use and that 
Washington defines at WAC 173-201A-600 and 173-201A-610 as the 
following: Fresh waters--Harvesting (fish harvesting), and Recreational 
Uses; Marine waters--Shellfish Harvesting (shellfish--clam, oyster, and 
mussel--harvesting), Harvesting (salmonid and other fish

[[Page 85430]]

harvesting, and crustacean and other shellfish--crabs, shrimp, 
scallops, etc.--harvesting), and Recreational Uses.

                                                      Table 1--Human Health Criteria for Washington
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      A                                                              B                                                     C
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Cancer slope     Relative      Reference                           Bio-
                                                factor, CSF      source       dose, RfD   Bio-accumulation    concentration     Water &      Organisms
             Chemical                CAS No.     (per mg/    contribution,      (mg/        factor (L/kg      factor  (L/kg    organisms   only  ([mu]g/
                                               kg[middot]d)     RSC (-)     kg[middot]d)       tissue)           tissue)       ([mu]g/L)        L)
                                    .........          (B1)          (B2)           (B3)              (B4)              (B5)        (C1)            (C2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. 1,1,1-4Trichloroethane.........      71556  ............          0.50              2                10  ................      20,000          50,000
2. 1,1,2,2-Tetrachloroethane......      79345           0.2             -   ............               8.4  ................         0.1             0.3
3. 1,1,2-Trichloroethane..........      79005         0.057             -   ............               8.9  ................        0.35            0.90
4. 1,1-Dichloroethylene...........      75354  ............          0.50           0.05               2.6  ................         700           4,000
5. 1,2,4-Trichlorobenzene.........     120821         0.029             -   ............               430  ................       0.036           0.037
6. 1,2-Dichlorobenzene............      95501  ............          0.50            0.3                82  ................         700             800
7. 1,2-Dichloroethane.............     107062        0.0033             -   ............               1.9  ................         8.9              73
8. 1,2-Dichloropropane............      78875  ............             -   ............  ................  ................  ..........  ..............
9. 1,2-Diphenylhydrazine..........     122667           0.8             -   ............                27  ................        0.01            0.02
10. 1,2-Trans-Dichloroethylene....     156605  ............          0.50           0.02               4.7  ................         200           1,000
11. 1,3-Dichlorobenzene...........     541731  ............          0.50          0.002               190  ................           2               2
12. 1,3-Dichloropropene...........     542756         0.122             -   ............               3.0  ................        0.22             1.2
13. 1,4-Dichlorobenzene...........     106467  ............          0.50           0.07                84  ................         200             200
14. 2,3,7,8-TCDD (Dioxin) **......    1746016       156,000             -   ............  ................             5,000     1.3E-08         1.4E-08
15. 2,4,6-Trichlorophenol.........      88062  ............             -   ............  ................  ................  ..........  ..............
16. 2,4-Dichlorophenol............     120832  ............          0.50          0.003                48  ................          10              10
17. 2,4-Dimethylphenol............     105679  ............             -   ............  ................  ................  ..........  ..............
18. 2,4-Dinitrophenol.............      51285  ............          0.50          0.002               4.4  ................          30             100
19. 2,4-Dinitrotoluene............     121142  ............             -   ............  ................  ................  ..........  ..............
20. 2-Chloronaphthalene...........      91587  ............          0.80           0.08               240  ................         100             100
21. 2-Chlorophenol................      95578  ............             -   ............  ................  ................  ..........  ..............
22. 2-Methyl-4,6-Dinitrophenol....     534521  ............          0.50         0.0003                10  ................           3               7
23. 3,3'-Dichlorobenzidine........      91941  ............             -   ............  ................  ................  ..........  ..............
24. 3-Methyl-4-Chlorophenol.......      59507  ............             -   ............  ................  ................  ..........  ..............
25. 4,4'-DDD......................      72548          0.24             -   ............           240,000  ................     7.9E-06         7.9E-06
26. 4,4'-DDE......................      72559         0.167             -   ............         3,100,000  ................     8.8E-07         8.8E-07
27. 4,4'-DDT......................      50293          0.34             -   ............         1,100,000  ................     1.2E-06         1.2E-06
28. Acenaphthene..................      83329  ............          0.50           0.06               510  ................          30              30
29. Acrolein......................     107028  ............             -   ............  ................  ................  ..........  ..............
30. Acrylonitrile.................     107131  ............             -   ............  ................  ................  ..........  ..............
31. Aldrin........................     309002            17             -   ............           650,000  ................     4.1E-08         4.1E-08
32. alpha-BHC.....................     319846           6.3             -   ............             1,500  ................     4.8E-05         4.8E-05
33. alpha-Endosulfan..............     959988  ............          0.50          0.006               200  ................           6               7
34. Anthracene....................     120127  ............          0.50            0.3               610  ................         100             100
35. Antimony......................    7440360  ............          0.50         0.0004  ................                 1           6              90
36. Arsenic **....................    7440382          1.75             -   ............  ................                44   \a\ 0.018        \a\ 0.14
37. Asbestos......................    1332214  ............             -   ............  ................  ................  ..........  ..............
38. Benzene.......................      71432  ............             -   ............  ................  ................  ..........  ..............
39. Benzidine.....................      92875  ............             -   ............  ................  ................  ..........  ..............
40. Benzo(a) Anthracene...........      56553          0.73             -   ............             3,900  ................     0.00016         0.00016
41. Benzo(a) Pyrene...............      50328           7.3             -   ............             3,900  ................     1.6E-05         1.6E-05
42. Benzo(b) Fluoranthene.........     205992          0.73             -   ............             3,900  ................     0.00016         0.00016
43. Benzo(k) Fluoranthene.........     207089         0.073             -   ............             3,900  ................      0.0016          0.0016
44. beta-BHC......................     319857           1.8             -   ............               180  ................      0.0013          0.0014
45. beta-Endosulfan...............   33213659  ............             -   ............  ................  ................  ..........  ..............
46. Bis(2-Chloroethyl) Ether......     111444  ............             -   ............  ................  ................  ..........  ..............
47. Bis(2-Chloro-1-Methylethyl)        108601  ............          0.50           0.04                10  ................         400             900
 Ether *..........................
48. Bis(2-Ethylhexyl) Phthalate...     117817         0.014             -   ............               710  ................       0.045           0.046
49. Bromoform.....................      75252        0.0045             -   ............               8.5  ................         4.6              12
50. Butylbenzyl Phthalate.........      85687        0.0019             -   ............            19,000  ................       0.013           0.013
51. Carbon Tetrachloride..........      56235  ............             -   ............  ................  ................  ..........  ..............
52. Chlordane.....................      57749          0.35             -   ............            60,000  ................     2.2E-05         2.2E-05
53. Chlorobenzene.................     108907  ............          0.50           0.02                22  ................         100             200
54. Chlorodibromomethane..........     124481          0.04             -   ............               5.3  ................        0.60             2.2
55. Chloroform....................      67663  ............          0.50           0.01               3.8  ................         100             600
56. Chrysene......................     218019        0.0073             -   ............             3,900  ................       0.016           0.016
57. Copper........................    7440508  ............             -   ............  ................  ................  ..........  ..............
58. Cyanide.......................      57125  ............          0.50         0.0006  ................                 1           9             100
59. Dibenzo(a,h) Anthracene.......      53703           7.3             -   ............             3,900  ................     1.6E-05         1.6E-05
60. Dichlorobromomethane..........      75274         0.034             -   ............               4.8  ................        0.73             2.8
61. Dieldrin......................      60571            16             -   ............           410,000  ................     7.0E-08         7.0E-08
62. Diethyl Phthalate.............      84662  ............          0.50            0.8               920  ................         200             200
63. Dimethyl Phthalate............     131113  ............          0.50             10             4,000  ................         600             600
64. Di-n-Butyl Phthalate..........      84742  ............          0.50            0.1             2,900  ................           8               8
65. Endosulfan Sulfate............    1031078  ............          0.50          0.006               140  ................           9  ..............
66. Endrin........................      72208  ............          0.80         0.0003            46,000  ................       0.002           0.002
67. Endrin Aldehyde...............    7421934  ............             -   ............  ................  ................  ..........  ..............
68. Ethylbenzene..................     100414  ............          0.50          0.022               160  ................          29              31
69. Fluoranthene..................     206440  ............          0.50           0.04             1,500  ................           6               6
70. Fluorene......................      86737  ............          0.50           0.04               710  ................          10              10
71. gamma-BHC; Lindane............      58899  ............          0.50         0.0047             2,500  ................        0.43            0.43

[[Page 85431]]

 
72. Heptachlor....................      76448           4.1             -   ............           330,000  ................     3.4E-07         3.4E-07
73. Heptachlor Epoxide............    1024573           5.5             -   ............            35,000  ................     2.4E-06         2.4E-06
74. Hexachlorobenzene.............     118741          1.02             -   ............            90,000  ................     5.0E-06         5.0E-06
75. Hexachlorobutadiene...........      87683          0.04             -   ............             1,100  ................        0.01            0.01
76. Hexachlorocyclopentadiene.....      77474  ............          0.50          0.006             1,300  ................           1               1
77. Hexachloroethane..............      67721          0.04             -   ............               600  ................        0.02            0.02
78. Indeno(1,2,3-cd) Pyrene.......     193395          0.73             -   ............             3,900  ................     0.00016         0.00016
79. Isophorone....................      78591  ............             -   ............  ................  ................  ..........  ..............
80. Methyl Bromide................      74839  ............          0.50           0.02               1.4  ................         300  ..............
81. Methylene Chloride............      75092         0.002             -   ............               1.6  ................          10             100
82. Methylmercury.................   22967926  ............       2.7E-05         0.0001  ................  ................  ..........   \b\ 0.03 (mg/
                                                                                                                                                     kg)
83. Nickel........................    7440020  ............          0.50           0.02  ................                47          80             100
84. Nitrobenzene..................      98953  ............          0.50          0.002               3.1  ................          30             100
85. N-Nitrosodimethylamine........      62759  ............             -   ............  ................  ................  ..........  ..............
86. N-Nitrosodi-n-Propylamine.....     621647  ............             -   ............  ................  ................  ..........  ..............
87. N-Nitrosodiphenylamine........      86306  ............             -   ............  ................  ................  ..........  ..............
88. Pentachlorophenol (PCP).......      87865           0.4             -   ............               520  ................       0.002           0.002
89. Phenol........................     108952  ............          0.50            0.6               1.9  ................       9,000          70,000
90. Polychlorinated Biphenyls       .........             2             -   ............  ................            31,200   \c\ 7E-06       \c\ 7E-06
 (PCBs)...........................
91. Pyrene........................     129000  ............          0.50           0.03               860  ................           8               8
92. Selenium......................    7782492  ............          0.50          0.005  ................               4.8          60             200
93. Tetrachloroethylene...........     127184        0.0021             -   ............                76  ................         2.4             2.9
94. Thallium **...................    7440280  ............             -       0.000068  ................               116         1.7             6.3
95. Toluene.......................     108883  ............          0.50         0.0097                17  ................          72             130
96. Toxaphene.....................    8001352  ............             -   ............  ................  ................  ..........  ..............
97. Trichloroethylene.............      79016          0.05             -   ............                13  ................         0.3             0.7
98. Vinyl Chloride................      75014           1.5             -   ............               1.7  ................  ..........            0.18
99. Zinc..........................    7440666  ............          0.50            0.3  ................                47       1,000           1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ This criterion refers to the inorganic form of arsenic only.
\b\ This criterion is expressed as the fish tissue concentration of methylmercury (mg methylmercury/kg fish). See Water Quality Criterion for the
  Protection of Human Health: Methylmercury (EPA-823-R-01-001, January 3, 2001) for how this value is calculated using the criterion equation in EPA's
  2000 Human Health Methodology rearranged to solve for a protective concentration in fish tissue rather than in water.
\c\ This criterion applies to total PCBs (e.g., the sum of all congener or isomer or homolog or Aroclor analyses).
* Bis(2-Chloro-1-Methylethyl) Ether was previously listed as Bis(2-Chloroisopropyl) Ether.
** These criteria were promulgated for Washington in the National Toxics Rule at 40 CFR 131.36, and are moved into 40 CFR 131.45 to have one
  comprehensive human health criteria rule for Washington.

E. Applicability of Criteria

    These new and revised human health criteria apply for CWA purposes 
in addition to any existing criteria already applicable to Washington's 
waters, including the state's narrative toxics criteria statement at 
WAC 173-201A-260(2)(a), and those human health criteria that Washington 
submitted on August 1, 2016, and EPA approved concurrent with this 
final rule.
    EPA replicates in 40 CFR 131.45 the same general rules of 
applicability for human health criteria as in 40 CFR 131.36(c), with 
one exception. For waters suitable for the establishment of low flow 
return frequencies (i.e., streams and rivers), this final rule provides 
that Washington must not use a low flow value below which numeric 
standards can be exceeded that is less stringent than the harmonic mean 
flow (a long-term mean flow value calculated by dividing the number of 
daily flows analyzed by the sum of the reciprocals of those daily 
flows), so that the criteria are implemented to be protective of the 
applicable designated use. Per the Revisions to the Methodology for 
Deriving Ambient Water Quality Criteria for the Protection of Human 
Health (65 FR 66444, November 3, 2000), EPA now recommends harmonic 
mean flow be used to implement human health criteria for both 
carcinogens and non-carcinogens.\67\ EPA received one comment on this 
provision, asking for clarification on whether this is consistent with 
Washington's current permitting approach of using the 30Q5 flow for 
non-carcinogens.\68\ In response, Washington's use of low flow 
statistics more stringent than the harmonic mean flow is consistent 
with EPA's final rule.
---------------------------------------------------------------------------

    \67\ See also USEPA. 2014. Water Quality Standards Handbook--
Chapter 5: General Policies. U.S. Environmental Protection Agency. 
Office of Water. Washington, DC EPA-820-B-14-004. https://www.epa.gov/wqs-tech/water-quality-standards-handbook.
    \68\ The 30Q5 flow is the lowest 30-day average flow event 
expected to occur once every five years, on average (determined 
hydrologically).
---------------------------------------------------------------------------

    Under the CWA, Congress gave states primary responsibility for 
developing and adopting WQS for their navigable waters (CWA section 
303(a)-(c)). Although EPA revises and establishes new human health 
criteria for Washington in this final rule, Washington continues to 
have the option to adopt and submit to EPA human health criteria for 
the pollutants in this final rule, consistent with CWA section 303(c) 
and EPA's implementing regulations at 40 CFR part 131.
    In its September 14, 2015 proposed rule, EPA proposed that if 
Washington adopted and submitted human health criteria, and EPA 
approved those criteria before finalizing its federal rule, EPA would 
not proceed with finalizing those criteria and Washington's approved 
criteria would be solely applicable for CWA purposes. EPA did not 
receive any comments opposing this provision, thus EPA is proceeding 
with such an approach. In this final rule, EPA is withdrawing 
Washington from the NTR at 40 CFR 131.36, and, with the exception of 
criteria for which EPA has approved Washington's criteria, EPA is 
incorporating the Washington-specific criteria in this rule (as well as 
the existing NTR criteria for arsenic, dioxin

[[Page 85432]]

and thallium) into 40 CFR 131.45 so there is a single comprehensive set 
of federally promulgated criteria for Washington. Therefore, the CWA-
effective numeric human health criteria in Washington consist of the 
federally promulgated criteria at 40 CFR 131.45 and those criteria that 
EPA approved at WAC 173-201A-240 in Washington's August 1, 2016 
submittal.
    Additionally, in its September 14, 2015 proposed rule, EPA proposed 
that if Washington adopted and submitted human health criteria after 
EPA finalized its rule, once EPA approved Washington's WQS, the 
pollutant-specific or site-specific EPA-approved criteria in 
Washington's WQS would become the solely effective criteria for CWA 
purposes and EPA's promulgated criteria for those pollutants or for 
that site would no longer apply. A few commenters supported this 
provision, where Washington's criteria for specific pollutants or sites 
become the only CWA-effective criteria upon EPA's approval, without any 
delay caused by EPA's withdrawal of the corresponding federal criteria. 
A few other commenters did not support this provision, and asked that 
EPA either delete the provision, or make clear that criteria adopted by 
the state would have to be at least as stringent as the federal 
criteria for EPA to approve and make the state criteria effective for 
CWA purposes. Upon further consideration of comments received on its 
proposed rule, EPA decided not to finalize this provision. Pursuant to 
40 CFR 131.21(c), EPA's federally promulgated WQS are and will be 
applicable for purposes of the CWA until EPA withdraws those federally 
promulgated WQS. EPA would undertake such a rulemaking to withdraw the 
federal criteria if and when Washington adopts and EPA approves 
corresponding criteria that meet the requirements of section 303(c) of 
the CWA and EPA's implementing regulations at 40 CFR part 131.

F. Alternative Regulatory Approaches and Implementation Mechanisms

    Washington has considerable discretion to implement these revised 
and new federal human health criteria through various water quality 
control programs including the NPDES program, which limits discharges 
to waters except in compliance with a NPDES permit. EPA's regulations 
at 40 CFR 131.14 authorize states and authorized tribes to adopt WQS 
variances to provide time to achieve the applicable WQS. 40 CFR part 
131 defines WQS variances at 131.3(o) as time-limited designated uses 
and supporting criteria for a specific pollutant(s) or water quality 
parameter(s) that reflect the highest attainable conditions during the 
term of the WQS variances. WQS variances adopted in accordance with 40 
CFR part 131 allow states and authorized tribes to address water 
quality challenges in a transparent and predictable way. Variances help 
states and authorized tribes focus on making incremental progress in 
improving water quality, rather than pursuing a downgrade of the 
underlying water quality goals through a designated use change, when 
the designated use is not attainable throughout the term of the 
variance due to one of the factors listed in 40 CFR 131.14. EPA's 
regulations at 40 CFR 122.47 provide the requirements when states and 
authorized tribes wish to include permit compliance schedules in their 
NPDES permits if dischargers need additional time to meet their water 
quality-based limits based on the applicable WQS. EPA's updated 
regulations at 40 CFR 131.15 require any state or authorized tribe 
wishing to use permit compliance schedules to also include provisions 
authorizing the use of permit compliance schedules after appropriate 
public involvement to ensure that a decision to allow permit compliance 
schedules derives from and complies with the applicable WQS. (80 FR 
51022, August 21, 2015).
    40 CFR 131.10 specifies how states and authorized tribes establish, 
modify or remove designated uses for their waters. 40 CFR 131.11 
specifies the requirements for establishing criteria to protect 
designated uses, including criteria modified to reflect site-specific 
conditions. In the context of this rulemaking, a site-specific 
criterion (SSC) is an alternative value to the federal human health 
criteria that could be applied on a watershed, area-wide, or waterbody-
specific basis that meets the regulatory test of protecting the 
designated use, being scientifically defensible, and ensuring the 
protection and maintenance of downstream WQS. A SSC may be more or less 
stringent than the otherwise applicable federal criterion. A SSC may be 
appropriate when further scientific data and analyses can bring added 
precision to express the concentration of a particular pollutant that 
protects the human health-related designated use in a particular 
waterbody.
    A few commenters supported EPA's acknowledgement of the 
flexibilities that Washington has available when implementing the final 
criteria in this rule, while others commented that these tools allow 
Washington to delay or avoid implementing the criteria. EPA did not 
propose to change, nor does this final rule change, any of the 
flexibilities already afforded to Washington by EPA's regulations to 
modify or remove designated uses, adopt variances, issue compliance 
schedules, or establish site-specific criteria. These implementation 
tools are important for making incremental progress and allowing the 
time for adaptive management when designated uses and associated 
criteria are difficult to attain. Washington may continue to use any of 
these regulatory flexibilities when implementing the final federal 
human health criteria.
a. Designating Uses
    EPA's final human health criteria apply to waters that Washington 
has designated for the following: Fresh waters--Harvesting (fish 
harvesting), Domestic Water (domestic water supply), and Recreational 
Uses; Marine waters--Shellfish Harvesting (shellfish--clam, oyster, and 
mussel--harvesting), Harvesting (salmonid and other fish harvesting, 
and crustacean and other shellfish--crabs, shrimp, scallops, etc.--
harvesting), and Recreational Uses (see WAC 173-201A-600 and WAC 173-
201A-610). If Washington removes the Domestic Water use but retains any 
of the other above designated uses for any particular waterbody 
affected by this final rule, and EPA finds that removal to be 
consistent with CWA section 303(c) and EPA's implementing regulations 
at 40 CFR part 131, then the federal organism-only criteria will apply 
in place of the federal water-plus-organism criteria. If Washington 
removes designated uses such that none of the above uses apply to any 
particular waterbody affected by this final rule and adopts the highest 
attainable use, as defined by 40 CFR 131.3(m), consistent with 40 CFR 
131.10(g), and EPA finds that removal to be consistent with CWA section 
303(c) and EPA's implementing regulations at 40 CFR part 131, then the 
federal human health criteria will no longer apply to that waterbody. 
Instead, any criteria associated with the newly designated highest 
attainable use would apply to that waterbody.
b. Variances and Compliance Schedules
    EPA's final human health criteria apply to use designations that 
Washington has already established. Concurrent with this final rule, 
EPA approved revisions to Washington's variance and compliance schedule 
authorizing provisions. Washington may use its EPA-approved variance 
procedures (see WAC 173-201A-420) to establish time-limited designated 
uses and criteria to apply for the purposes specified in 40 CFR 131.14 
as it pertains

[[Page 85433]]

to federal criteria when adopting such variances. Washington has 
sufficient authority to use variances when implementing the human 
health criteria as long as such variances are adopted consistent with 
40 CFR 131.14, and submitted to EPA for review under CWA section 
303(c). Similarly, Washington may use its EPA-approved regulation 
authorizing the use of permit compliance schedules (see WAC 173-201A-
510(4)), consistent with 40 CFR 131.15, to grant compliance schedules, 
as appropriate, for WQBELs based on the federal criteria. These state 
regulations are not affected by this final rule.
c. Site-Specific Criteria
    As discussed in section III.E, if Washington adopts and EPA 
approves site-specific criteria that fully meet the requirements of 
section 303(c) of the CWA and EPA's implementing regulations at 40 CFR 
part 131, EPA will undertake a rulemaking to withdraw the corresponding 
federal criteria.

IV. Economic Analysis

    Under the CWA, water quality criteria are set on the basis of the 
latest scientific knowledge. EPA is not required under the CWA nor 
obligated under Executive Orders 12866 and 13563 to conduct an economic 
analysis of the criteria. Costs cannot be considered in establishing 
water quality criteria as part of WQS. Nonetheless, EPA conducted a 
cost analysis for the criteria in this final rule for the purpose of 
transparency and presents this information reflecting the potential 
economic effects of the rule.
    These WQS may serve as a basis for development of NPDES permit 
limits. Washington has NPDES permitting authority, and retains 
considerable discretion in implementing standards. EPA evaluated the 
potential costs to NPDES dischargers associated with state 
implementation of EPA's final criteria. This analysis is documented in 
Final Economic Analysis for the Revision of Certain Federal Water 
Quality Criteria Applicable to Washington, which can be found in the 
record for this rulemaking.
    Any NPDES-permitted facility that discharges pollutants for which 
the revised human health criteria are more stringent than the 
applicable aquatic life criteria (or for which human health criteria 
are the only applicable criteria) could potentially incur compliance 
costs. The types of affected facilities could include industrial 
facilities and POTWs discharging wastewater to surface waters (i.e., 
point sources). EPA did not attribute compliance with water quality-
based effluent limitations (WQBELs) reflective of existing federal 
human health criteria applicable to Washington (hereafter referred to 
as ``baseline criteria'') to the final rule. Once in compliance with 
WQBELs reflective of baseline criteria, EPA expects that dischargers 
will continue to use the same types of controls to come into compliance 
with the revised criteria; EPA did not fully evaluate the potential for 
costs to nonpoint sources,\69\ such as agricultural runoff, that could 
be incurred under a TMDL for this analysis, but did analyze the 
administrative costs to the state of preparing TMDLs for potentially 
incrementally impaired waters. Actual costs of implementation of TMDLs 
is beyond the scope of this analysis.
---------------------------------------------------------------------------

    \69\ The CWA does not regulate nonpoint sources. However, EPA 
recognizes that the state may require controls for nonpoint sources 
as part of potential incremental TMDLs. It is difficult to model and 
evaluate the potential cost impacts of this final rule to nonpoint 
sources because they are intermittent, variable, and occur under 
hydrologic or climatic conditions associated with precipitation 
events. Also, data on instream and discharge levels of the 
pollutants of concern after dischargers have implemented controls to 
meet current WQS, total maximum daily loads (TMDLs) for impaired 
waters, or other water quality improvement plans, are not available. 
Therefore, trying to determine which sources would not achieve WQS 
based on the revised human health criteria after complying with 
existing regulations and policies may not be possible. In addition, 
legacy contamination (e.g., in sediment) may be a source of ongoing 
loading. Atmospheric deposition may also contribute loadings of the 
pollutants of concern (e.g., mercury). EPA did not estimate sediment 
remediation costs, or air pollution controls costs, for this 
analysis because EPA did not have data on the contribution of these 
sources, and because control costs for deposition may be covered by 
Clean Air Act rules.
---------------------------------------------------------------------------

A. Identifying Affected Entities

    EPA identified 406 point source facilities that could ultimately be 
affected by this final rule. Of these potentially affected facilities, 
73 are major dischargers and 333 are minor dischargers. EPA did not 
include general permit facilities in its analysis because data for such 
facilities are limited, and flows are usually negligible. Of the 
potentially affected facilities, EPA evaluated a sample of 17 major 
facilities. Minor facilities are unlikely to incur costs as a result of 
implementation of the rule, because minor facilities are typically 
those that do not discharge toxics in toxic amounts and discharge less 
than 1 million gallons per day (mgd). Although lower human health 
criteria could potentially change this categorization, EPA did not have 
effluent data on toxic pollutants to evaluate minor facilities for this 
analysis. Table 2 summarizes these potentially affected facilities by 
type and category.

                                    Table 2--Potentially Affected Facilities
----------------------------------------------------------------------------------------------------------------
                            Category                                   Minor           Major            All
----------------------------------------------------------------------------------------------------------------
Municipal.......................................................             184              48             232
Industrial......................................................             149              25             174
                                                                 -----------------------------------------------
    Total.......................................................             333              73             406
----------------------------------------------------------------------------------------------------------------

B. Method for Estimating Costs

    EPA evaluated the two major municipal facilities with design flows 
greater than 100 mgd and a large industrial refinery, to attempt to 
capture the facilities with the potential for the largest costs. For 
the remaining major facilities, EPA evaluated a random sample of 
facilities to represent discharger type and category. For all sample 
facilities, EPA evaluated existing baseline permit conditions, 
reasonable potential to exceed human health criteria based on the final 
rule, and potential to exceed projected effluent limitations based on 
the last three years of effluent monitoring data (if available). In 
instances of exceedances of projected effluent limitations under the 
final criteria, EPA determined the likely compliance scenarios and 
costs. Only compliance actions and costs that would be needed above the 
baseline level of controls are attributable to the final rule.
    EPA assumed that dischargers will pursue the least cost means of 
compliance with WQBELs. Incremental compliance actions attributable to 
the final rule may include pollution prevention, end-of-pipe treatment, 
and alternative compliance mechanisms (e.g., variances). EPA annualized 
one-

[[Page 85434]]

time costs (capital costs and variance costs) over 20 years using a 3 
percent discount rate to obtain total annual costs per facility. For 
the random sample, EPA extrapolated the annualized costs based on the 
sampling weight for each sample facility. To obtain an estimate of 
total costs to point sources, EPA added the results for the certainty 
sample to the extrapolated random sample costs.

C. Results

    Based on the results for 17 sample facilities across 8 industrial 
and municipal categories,\70\ EPA estimated a total annual compliance 
cost of approximately $126,000 to $150,000 for all major dischargers in 
the state (using a 3 percent discount rate). Only five facilities are 
estimated to incur pollution prevention program costs, while two 
facilities are expected to also incur costs of obtaining a variance. 
Most of the facilities would not bear any cost. The low end of the 
range reflects the assumption that the compliance actions (e.g., 
pollution prevention) will result in compliance with projected effluent 
limits, whereas the high scenario reflects projected effluent limits 
not being met, and thus includes the estimated administrative cost of 
also obtaining a variance. All compliance costs are for industrial 
facilities, and are attributable to the human health criterion for 
methylmercury.
---------------------------------------------------------------------------

    \70\ Seven industrial categories (mining, food and kindred 
products, paper and allied products, chemicals and allied products, 
petroleum refining and related industries, primary metal industries, 
and transportation and public utilities (except POTWs)) and 
municipal POTWs.
---------------------------------------------------------------------------

    If the revised criteria result in an incremental increase in 
impaired waters, resulting in the need for TMDL development, there 
could also be some costs to nonpoint sources of pollution. Using 
available ambient monitoring data, EPA compared pollutant 
concentrations to the baseline and final criteria, identifying 
waterbodies that may be incrementally impaired (i.e., impaired under 
the final criteria but not under the baseline). For the parameters and 
stations for which EPA had sufficient monitoring data available to 
evaluate, there were 50 impairments under the baseline criteria and 124 
under the final criteria, for a total of 74 potential incremental 
impairments (or a 148 percent increase relative to the baseline; 
including for methylmercury, PCBs, and DDT). This increase indicates 
the potential for nonpoint sources to bear some compliance costs, 
although data are not available to estimate the magnitude of these 
costs. The control of nonpoint sources such as in the context of a TMDL 
could result in different requirements, and thus different costs, for 
point sources.
    If the net increase in potential impairments is any indication of 
the potential increase in the number of TMDLs, then the total 
administrative costs for TMDL development could be in the range of $2.7 
million to $3.0 million based on national average single-cause single-
waterbody TMDL development costs from U.S. EPA (2001; updated to 2014 
dollars). However, these costs may be reduced if Ecology develops 
multi-cause or multi-waterbody TMDLs. If these costs are spread over 8 
to 15 years, at a discount rate of 3 percent, the annualized costs of 
developing TMDLs are $229,000 to $422,000.
    Combining the potential facility compliance costs and TMDL 
administrative costs results in total annual costs of $355,000 to 
$572,000, at a 3 percent discount rate.

V. Statutory and Executive Order Reviews

A. Executive Order 12866 (Regulatory Planning and Review) and Executive 
Order 13563 (Improving Regulation and Regulatory Review)

    It has been determined that this final rule is not a ``significant 
regulatory action'' under the terms of Executive Order 12866 (58 FR 
51735, October 4, 1993) and is, therefore, not subject to review under 
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). The 
final rule does not establish any requirements directly applicable to 
regulated entities or other sources of toxic pollutants. However, these 
WQS may serve as a basis for development of NPDES permit limits. 
Washington has NPDES permitting authority, and retains considerable 
discretion in implementing standards. In the spirit of Executive Order 
12866, EPA evaluated the potential costs to NPDES dischargers 
associated with state implementation of EPA's final criteria. This 
analysis, Final Economic Analysis for the Revision of Certain Federal 
Water Quality Criteria Applicable to Washington, is summarized in 
section IV of the preamble and is available in the docket.

B. Paperwork Reduction Act

    This action does not impose any direct new information collection 
burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 
3501 et seq. Actions to implement these WQS could entail additional 
paperwork burden. Burden is defined at 5 CFR 1320.3(b). This action 
does not include any information collection, reporting, or record-
keeping requirements.

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. This 
action will not impose any requirements on small entities. EPA has the 
authority to promulgate WQS in any case where the Administrator 
determines that a new or revised standard is necessary to meet the 
requirements of the CWA. EPA-promulgated standards are implemented 
through various water quality control programs including the NPDES 
program, which limits discharges to navigable waters except in 
compliance with an NPDES permit. The CWA requires that all NPDES 
permits include any limits on discharges that are necessary to meet 
applicable WQS. Thus, under the CWA, EPA's promulgation of WQS 
establishes standards that the state implements through the NPDES 
permit process. The state has discretion in developing discharge 
limits, as needed to meet the standards. As a result of this action, 
the State of Washington will need to ensure that permits it issues 
include any limitations on discharges necessary to comply with the 
standards established in the final rule. In doing so, the state will 
have a number of choices associated with permit writing. While 
Washington's implementation of the rule may ultimately result in new or 
revised permit conditions for some dischargers, including small 
entities, EPA's action, by itself, does not impose any of these 
requirements on small entities; that is, these requirements are not 
self-implementing.

D. Unfunded Mandates Reform Act

    This action contains no federal mandates under the provisions of 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 
1531-1538 for state, local, or tribal governments or the private 
sector. As these water quality criteria are not self-implementing, 
EPA's action imposes no enforceable duty on any state, local or tribal 
governments or the private sector. Therefore, this action is not 
subject to the requirements of sections 202 or 205 of UMRA.
    This action is also not subject to the requirements of section 203 
of UMRA because it contains no regulatory requirements that could 
significantly or uniquely affect small governments.

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

[[Page 85435]]

government and the states, or on the distribution of power and 
responsibilities among the various levels of government. This rule does 
not alter Washington's considerable discretion in implementing these 
WQS, nor will it preclude Washington from adopting WQS in the future 
that EPA concludes meet the requirements of the CWA, which will 
eliminate the need for federal standards. Thus, Executive Order 13132 
does not apply to this action.

F. Executive Order 13175 (Consultation and Coordination With Indian 
Tribal Governments)

    This action has tribal implications. However, it will neither 
impose substantial direct compliance costs on federally recognized 
tribal governments, nor preempt tribal law. In the State of Washington, 
there are 29 federally recognized Indian tribes. To date, nine of these 
Indian tribes have been approved for TAS for CWA sections 303 and 
401.\71\ Of these nine tribes, seven have EPA-approved WQS in their 
respective jurisdictions.\72\ This rule could affect federally 
recognized Indian tribes in Washington because the numeric criteria for 
Washington will apply to waters adjacent to (or upstream or downstream 
of) the tribal waters, where many of those tribes have treaty rights to 
take fish for their subsistence. Additionally, there are ten federally 
recognized Indian tribes in the Columbia River Basin located in the 
states of Oregon and Idaho that this rule could impact because their 
waters could affect or be affected by the water quality of Washington's 
downstream or upstream waters.
---------------------------------------------------------------------------

    \71\ https://water.epa.gov/scitech/swguidance/standards/wqslibrary/approvtable.cfm.
    \72\ https://yosemite.epa.gov/r10/water.nsf/34090d07b77d50bd88256b79006529e8/dd2a4df00fd7ae1a88256e0500680e86!OpenDocument. Note that this number 
does not include the Confederated Tribes of the Colville 
Reservation, which has federally promulgated WQS from 1989. EPA is 
currently reviewing the Colville Tribe's application for TAS.
---------------------------------------------------------------------------

    EPA consulted with federally recognized tribal officials under 
EPA's Policy on Consultation and Coordination with Indian Tribes early 
in the process of developing this rule to permit them to have 
meaningful and timely input into its development. In February and March 
2015, EPA held tribes-only technical staff and leadership consultation 
sessions to hear their views and answer questions of all interested 
tribes on the proposed rule. Representatives from approximately 23 
tribes and four tribal consortia participated in two leadership 
meetings held in March 2015. EPA and tribes have also met regularly 
since November 2012 to discuss Washington's human health criteria at 
both the tribal leadership level and technical staff level. The tribes 
have repeatedly asked EPA to promulgate federal human health criteria 
for Washington if the state did not do so in a timely and protective 
manner. At these meetings, the tribes consistently emphasized that the 
human health criteria should be derived using at least a minimum FCR 
value of 175 g/day, a cancer risk level of 10-6, and the 
latest scientific information from EPA's 304(a) recommended criteria. 
EPA considered the input received during consultation with tribes when 
developing this final rule (see section III for additional discussion 
of how EPA considered tribal input).
    In subsequent coordination with tribes, EPA received a letter on 
August 5, 2016, from the Northwest Indian Fisheries Commission 
disagreeing with EPA's potential adjustments to the RSC from the 
proposed rule issued on September 14, 2015 to the final rule as a 
result of public comments. The tribes expressed concern that less 
stringent human health criteria as a result of the RSC adjustment would 
result in lower protection of designated uses and limit the ability to 
exercise tribal treaty rights, especially in light of a FCR that 
underestimates tribal consumption. EPA considered this information 
carefully before finalizing this rule, but for the reasons stated 
above, decided to adjust the RSC to account for inclusion of some 
marine fish in the FCR. This results in protective criteria that 
account for other routes of exposure in addition to drinking water and 
fish and shellfish from inland and nearshore waters and is consistent 
with EPA's guidance.

G. Executive Order 13045 (Protection of Children From Environmental 
Health and Safety Risks)

    This rule is not subject to Executive Order 13045, because it is 
not economically significant as defined in Executive Order 12866, and 
because the environmental health or safety risks addressed by this 
action do not present a disproportionate risk to children.

H. Executive Order 13211 (Actions That Significantly Affect Energy 
Supply, Distribution, or Use)

    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.

I. National Technology Transfer and Advancement Act of 1995

    This final rulemaking does not involve technical standards.

J. Executive Order 12898 (Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations)

    This action will not have disproportionately high and adverse human 
health or environmental effects on minority or low-income populations. 
Conversely, this action identifies and ameliorates disproportionately 
high and adverse human health effects on minority populations and low-
income populations in Washington. EPA developed the human health 
criteria included in this final rule specifically to protect 
Washington's designated uses, using the most current science, including 
local and regional information on fish consumption. Applying these 
criteria to waters in the State of Washington will afford a greater 
level of protection to both human health and the environment.

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).

List of Subjects in 40 CFR Part 131

    Environmental protection, Indians-lands, Intergovernmental 
relations, Reporting and recordkeeping requirements, Water pollution 
control.

    Dated: November 15, 2016.
Gina McCarthy,
Administrator.

    For the reasons set forth in the preamble, EPA amends 40 CFR part 
131 as follows:

PART 131--WATER QUALITY STANDARDS

0
1. The authority citation for part 131 continues to read as follows:

    Authority:  33 U.S.C. 1251 et seq.

Subpart D--Federally Promulgated Water Quality Standards


Sec.  131.36   [Amended]

0
2. In Sec.  131.36, remove paragraph (d)(14).

0
3. Add Sec.  131.45 to read as follows:


Sec.  131.45   Revision of certain Federal water quality criteria 
applicable to Washington.

    (a) Scope. This section promulgates human health criteria for 
priority toxic

[[Page 85436]]

pollutants in surface waters in Washington.
    (b) Criteria for priority toxic pollutants in Washington. The 
applicable human health criteria are shown in Table 1.

                                                      Table 1--Human Health Criteria for Washington
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      A                                                              B                                                     C
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Cancer slope     Relative      Reference                           Bio-          Water &
                                                factor, CSF      source       dose, RfD   Bio-accumulation    concentration    organisms  Organisms only
             Chemical                CAS No.     (per mg/    contribution,      (mg/        factor (L/kg      factor  (L/kg   ([micro]g/    ([micro]g/L)
                                               kg[middot]d)     RSC (-)     kg[middot]d)       tissue)           tissue)          L)
                                    .........          (B1)          (B2)           (B3)              (B4)              (B5)        (C1)            (C2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. 1,1,1-Trichloroethane..........      71556  ............          0.50              2                10  ................      20,000          50,000
2. 1,1,2,2-Tetrachloroethane......      79345           0.2             -   ............               8.4  ................         0.1             0.3
3. 1,1,2-Trichloroethane..........      79005         0.057             -   ............               8.9  ................        0.35            0.90
4. 1,1-Dichloroethylene...........      75354  ............          0.50           0.05               2.6  ................         700           4,000
5. 1,2,4-Trichlorobenzene.........     120821         0.029             -   ............               430  ................       0.036           0.037
6. 1,2-Dichlorobenzene............      95501  ............          0.50            0.3                82  ................         700             800
7. 1,2-Dichloroethane.............     107062        0.0033             -   ............               1.9  ................         8.9              73
8. 1,2-Dichloropropane............      78875  ............             -   ............  ................  ................  ..........  ..............
9. 1,2-Diphenylhydrazine..........     122667           0.8             -   ............                27  ................        0.01            0.02
10. 1,2-Trans-Dichloroethylene....     156605  ............          0.50           0.02               4.7  ................         200           1,000
11. 1,3-Dichlorobenzene...........     541731  ............          0.50          0.002               190  ................           2               2
12. 1,3-Dichloropropene...........     542756         0.122             -   ............               3.0  ................        0.22             1.2
13. 1,4-Dichlorobenzene...........     106467  ............          0.50           0.07                84  ................         200             200
14. 2,3,7,8-TCDD (Dioxin) **......    1746016       156,000             -   ............  ................             5,000     1.3E-08         1.4E-08
15. 2,4,6-Trichlorophenol.........      88062  ............             -   ............  ................  ................  ..........  ..............
16. 2,4-Dichlorophenol............     120832  ............          0.50          0.003                48  ................          10              10
17. 2,4-Dimethylphenol............     105679  ............             -   ............  ................  ................  ..........  ..............
18. 2,4-Dinitrophenol.............      51285  ............          0.50          0.002               4.4  ................          30             100
19. 2,4-Dinitrotoluene............     121142  ............             -   ............  ................  ................  ..........  ..............
20. 2-Chloronaphthalene...........      91587  ............          0.80           0.08               240  ................         100             100
21. 2-Chlorophenol................      95578  ............             -   ............  ................  ................  ..........  ..............
22. 2-Methyl-4,6-Dinitrophenol....     534521  ............          0.50         0.0003                10  ................           3               7
23. 3,3'-Dichlorobenzidine........      91941  ............             -   ............  ................  ................  ..........  ..............
24. 3-Methyl-4-Chlorophenol.......      59507  ............             -   ............  ................  ................  ..........  ..............
25. 4,4'-DDD......................      72548          0.24             -   ............           240,000  ................     7.9E-06         7.9E-06
26. 4,4'-DDE......................      72559         0.167             -   ............         3,100,000  ................     8.8E-07         8.8E-07
27. 4,4'-DDT......................      50293          0.34             -   ............         1,100,000  ................     1.2E-06         1.2E-06
28. Acenaphthene..................      83329  ............          0.50           0.06               510  ................          30              30
29. Acrolein......................     107028  ............             -   ............  ................  ................  ..........  ..............
30. Acrylonitrile.................     107131  ............             -   ............  ................  ................  ..........  ..............
31. Aldrin........................     309002            17             -   ............           650,000  ................     4.1E-08         4.1E-08
32. alpha-BHC.....................     319846           6.3             -   ............             1,500  ................     4.8E-05         4.8E-05
33. alpha-Endosulfan..............     959988  ............          0.50          0.006               200  ................           6               7
34. Anthracene....................     120127  ............          0.50            0.3               610  ................         100             100
35. Antimony......................    7440360  ............          0.50         0.0004  ................                 1           6              90
36. Arsenic **....................    7440382          1.75             -   ............  ................                44   \a\ 0.018        \a\ 0.14
37. Asbestos......................    1332214  ............             -   ............  ................  ................  ..........  ..............
38. Benzene.......................      71432  ............             -   ............  ................  ................  ..........  ..............
39. Benzidine.....................      92875  ............             -   ............  ................  ................  ..........  ..............
40. Benzo(a) Anthracene...........      56553          0.73             -   ............             3,900  ................     0.00016         0.00016
41. Benzo(a) Pyrene...............      50328           7.3             -   ............             3,900  ................     1.6E-05         1.6E-05
42. Benzo(b) Fluoranthene.........     205992          0.73             -   ............             3,900  ................     0.00016         0.00016
43. Benzo(k) Fluoranthene.........     207089         0.073             -   ............             3,900  ................      0.0016          0.0016
44. beta-BHC......................     319857           1.8             -   ............               180  ................      0.0013          0.0014
45. beta-Endosulfan...............   33213659  ............             -   ............  ................  ................  ..........  ..............
46. Bis(2-Chloroethyl) Ether......     111444  ............             -   ............  ................  ................  ..........  ..............
47. Bis(2-Chloro-1-Methylethyl)        108601  ............          0.50           0.04                10  ................         400             900
 Ether *..........................
48. Bis(2-Ethylhexyl) Phthalate...     117817         0.014             -   ............               710  ................       0.045           0.046
49. Bromoform.....................      75252        0.0045             -   ............               8.5  ................         4.6              12
50. Butylbenzyl Phthalate.........      85687        0.0019             -   ............            19,000  ................       0.013           0.013
51. Carbon Tetrachloride..........      56235  ............             -   ............  ................  ................  ..........  ..............
52. Chlordane.....................      57749          0.35             -   ............            60,000  ................     2.2E-05         2.2E-05
53. Chlorobenzene.................     108907  ............          0.50           0.02                22  ................         100             200
54. Chlorodibromomethane..........     124481          0.04             -   ............               5.3  ................        0.60             2.2
55. Chloroform....................      67663  ............          0.50           0.01               3.8  ................         100             600
56. Chrysene......................     218019        0.0073             -   ............             3,900  ................       0.016           0.016
57. Copper........................    7440508  ............             -   ............  ................  ................  ..........  ..............
58. Cyanide.......................      57125  ............          0.50         0.0006  ................                 1           9             100
59. Dibenzo(a,h) Anthracene.......      53703           7.3             -   ............             3,900  ................     1.6E-05         1.6E-05
60. Dichlorobromomethane..........      75274         0.034             -   ............               4.8  ................        0.73             2.8
61. Dieldrin......................      60571            16             -   ............           410,000  ................     7.0E-08         7.0E-08
62. Diethyl Phthalate.............      84662  ............          0.50            0.8               920  ................         200             200
63. Dimethyl Phthalate............     131113  ............          0.50             10             4,000  ................         600             600
64. Di-n-Butyl Phthalate..........      84742  ............          0.50            0.1             2,900  ................           8               8
65. Endosulfan Sulfate............    1031078  ............          0.50          0.006               140  ................           9  ..............
66. Endrin........................      72208  ............          0.80         0.0003            46,000  ................       0.002           0.002
67. Endrin Aldehyde...............    7421934  ............             -   ............  ................  ................  ..........  ..............
68. Ethylbenzene..................     100414  ............          0.50          0.022               160  ................          29              31
69. Fluoranthene..................     206440  ............          0.50           0.04             1,500  ................           6               6
70. Fluorene......................      86737  ............          0.50           0.04               710  ................          10              10
71. gamma-BHC; Lindane............      58899  ............          0.50         0.0047             2,500  ................        0.43            0.43

[[Page 85437]]

 
72. Heptachlor....................      76448           4.1             -   ............           330,000  ................     3.4E-07         3.4E-07
73. Heptachlor Epoxide............    1024573           5.5             -   ............            35,000  ................     2.4E-06         2.4E-06
74. Hexachlorobenzene.............     118741          1.02             -   ............            90,000  ................     5.0E-06         5.0E-06
75. Hexachlorobutadiene...........      87683          0.04             -   ............             1,100  ................        0.01            0.01
76. Hexachlorocyclopentadiene.....      77474  ............          0.50          0.006             1,300  ................           1               1
77. Hexachloroethane..............      67721          0.04             -   ............               600  ................        0.02            0.02
78. Indeno(1,2,3-cd) Pyrene.......     193395          0.73             -   ............             3,900  ................     0.00016         0.00016
79. Isophorone....................      78591  ............             -   ............  ................  ................  ..........  ..............
80. Methyl Bromide................      74839  ............          0.50           0.02               1.4  ................         300  ..............
81. Methylene Chloride............      75092         0.002             -   ............               1.6  ................          10             100
82. Methylmercury.................   22967926  ............       2.7E-05         0.0001  ................  ................  ..........   \b\ 0.03 (mg/
                                                                                                                                                     kg)
83. Nickel........................    7440020  ............          0.50           0.02  ................                47          80             100
84. Nitrobenzene..................      98953  ............          0.50          0.002               3.1  ................          30             100
85. N-Nitrosodimethylamine........      62759  ............             -   ............  ................  ................  ..........  ..............
86. N-Nitrosodi-n-Propylamine.....     621647  ............             -   ............  ................  ................  ..........  ..............
87. N-Nitrosodiphenylamine........      86306  ............             -   ............  ................  ................  ..........  ..............
88. Pentachlorophenol (PCP).......      87865           0.4             -   ............               520  ................       0.002           0.002
89. Phenol........................     108952  ............          0.50            0.6               1.9  ................       9,000          70,000
90. Polychlorinated Biphenyls       .........             2             -   ............  ................            31,200   \c\ 7E-06       \c\ 7E-06
 (PCBs)...........................
91. Pyrene........................     129000  ............          0.50           0.03               860  ................           8               8
92. Selenium......................    7782492  ............          0.50          0.005  ................               4.8          60             200
93. Tetrachloroethylene...........     127184        0.0021             -   ............                76  ................         2.4             2.9
94. Thallium **...................    7440280  ............             -       0.000068  ................               116         1.7             6.3
95. Toluene.......................     108883  ............          0.50         0.0097                17  ................          72             130
96. Toxaphene.....................    8001352  ............             -   ............  ................  ................  ..........  ..............
97. Trichloroethylene.............      79016          0.05             -   ............                13  ................         0.3             0.7
98. Vinyl Chloride................      75014           1.5             -   ............               1.7  ................  ..........            0.18
99. Zinc..........................    7440666  ............          0.50            0.3  ................                47       1,000           1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ This criterion refers to the inorganic form of arsenic only.
\b\ This criterion is expressed as the fish tissue concentration of methylmercury (mg methylmercury/kg fish). See Water Quality Criterion for the
  Protection of Human Health: Methylmercury (EPA-823-R-01-001, January 3, 2001) for how this value is calculated using the criterion equation in EPA's
  2000 Human Health Methodology rearranged to solve for a protective concentration in fish tissue rather than in water.
\c\ This criterion applies to total PCBs (e.g., the sum of all congener or isomer or homolog or Aroclor analyses).
* Bis(2-Chloro-1-Methylethyl) Ether was previously listed as Bis(2-Chloroisopropyl) Ether.
** These criteria were promulgated for Washington in the National Toxics Rule at 40 CFR 131.36, and are moved into 40 CFR 131.45 to have one
  comprehensive human health criteria rule for Washington.

    (c) Applicability. (1) The criteria in paragraph (b) of this 
section apply to waters with Washington's designated uses cited in 
paragraph (d) of this section and apply concurrently with other 
applicable water quality criteria.
    (2) The criteria established in this section are subject to 
Washington's general rules of applicability in the same way and to the 
same extent as are other federally promulgated and state-adopted 
numeric criteria when applied to the same use classifications in 
paragraph (d) of this section.
    (i) For all waters with mixing zone regulations or implementation 
procedures, the criteria apply at the appropriate locations within or 
at the boundary of the mixing zones; otherwise the criteria apply 
throughout the waterbody including at the end of any discharge pipe, 
conveyance or other discharge point within the waterbody.
    (ii) The state must not use a low flow value below which numeric 
non-carcinogen and carcinogen human health criteria can be exceeded 
that is less stringent than the harmonic mean flow for waters suitable 
for the establishment of low flow return frequencies (i.e., streams and 
rivers). Harmonic mean flow is a long-term mean flow value calculated 
by dividing the number of daily flows analyzed by the sum of the 
reciprocals of those daily flows.
    (iii) If the state does not have such a low flow value for numeric 
criteria, then none will apply and the criteria in paragraph (b) of 
this section herein apply at all flows.
    (d) Applicable use designations. (1) All waters in Washington 
assigned to the following use classifications are subject to the 
criteria identified in paragraph (d)(2) of this section:
    (i) Fresh waters--
    (A) Miscellaneous uses: Harvesting (Fish harvesting);
    (B) Recreational uses;
    (C) Water supply uses: Domestic water (Domestic water supply);
    (ii) Marine waters--
    (A) Miscellaneous uses: Harvesting (Salmonid and other fish 
harvesting, and crustacean and other shellfish (crabs, shrimp, 
scallops, etc.) harvesting);
    (B) Recreational uses;
    (C) Shellfish harvesting: Shellfish harvest (Shellfish (clam, 
oyster, and mussel) harvesting)

    Note to paragraph (d)(1):  The source of these uses is 
Washington Administrative Code 173-201A-600 for Fresh waters and 
173-201A-610 for Marine waters.

    (2) For Washington waters that include the use classification of 
Domestic Water, the criteria in column C1 and the methylmercury 
criterion in column C2 of Table 1 in paragraph (b) of this section 
apply. For Washington waters that include any of the following use 
classifications but do not include the use classification of Domestic 
Water, the criteria in column C2 of Table 1 in paragraph (b) of this 
section apply: Harvesting (fresh and marine waters), Recreational Uses 
(fresh and marine waters), and Shellfish Harvesting.

[FR Doc. 2016-28424 Filed 11-25-16; 8:45 am]
 BILLING CODE 6560-50-P
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