81_FR_85645 81 FR 85417 - Revision of Certain Federal Water Quality Criteria Applicable to Washington

81 FR 85417 - Revision of Certain Federal Water Quality Criteria Applicable to Washington

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 228 (November 28, 2016)

Page Range85417-85437
FR Document2016-28424

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. 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.

Federal Register, Volume 81 Issue 228 (Monday, November 28, 2016)
[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Rules and Regulations]
[Pages 85417-85437]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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 
http://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 http://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: [email protected].

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
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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.
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    \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.
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    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.
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    \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.
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    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\
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    \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.
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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.
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    \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.
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    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.
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    \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.
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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\
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    \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.
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    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.
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    \15\ USEPA. 2011. EPA Exposure Factors Handbook. 2011 edition 
(EPA 600/R-090/052F). http://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.
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    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\
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    \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.''
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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\ http://cfpub.epa.gov/ncea/iris/index.cfm?fuseaction=iris.showQuickView&substance_nmbr=1012.
    \24\ http://cfpub.epa.gov/ncea/iris/index.cfm?fuseaction=iris.showQuickView&substance_nmbr=1024.
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    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 http://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\
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    \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.
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    \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).
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    \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.
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    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.
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    \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 http://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\ http://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. http://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.
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    \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\ http://water.epa.gov/scitech/swguidance/standards/wqslibrary/approvtable.cfm.
    \72\ http://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



                                                                 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                                    85417

                                                Order 13132 (64 FR 43255, August 10,                      Business Regulatory Enforcement                         List of Subjects in 40 CFR Part 52
                                                1999);                                                    Fairness Act of 1996, generally provides
                                                   • Is not an economically significant                   that before a rule may take effect, the                   Environmental protection, Air
                                                regulatory action based on health or                      agency promulgating the rule must                       pollution control, Incorporation by
                                                safety risks subject to Executive Order                   submit a rule report, which includes a                  reference, Intergovernmental relations,
                                                13045 (62 FR 19885, April 23, 1997);                      copy of the rule, to each House of the                  Nitrogen dioxide, Ozone, Reporting and
                                                   • Is not a significant regulatory action               Congress and to the Comptroller General                 recordkeeping requirements, Volatile
                                                subject to Executive Order 13211 (66 FR                   of the United States. EPA will submit a                 organic compounds.
                                                28355, May 22, 2001);                                     report containing this action and other                   Dated: November 7, 2016.
                                                   • Is not subject to requirements of                    required information to the U.S. Senate,                Heather McTeer Toney,
                                                section 12(d) of the National                             the U.S. House of Representatives, and
                                                Technology Transfer and Advancement                                                                               Regional Administrator, Region 4.
                                                                                                          the Comptroller General of the United
                                                Act of 1995 (15 U.S.C. 272 note) because                  States prior to publication of the rule in                  40 CFR part 52 is amended as follows:
                                                application of those requirements would                   the Federal Register. A major rule
                                                be inconsistent with the CAA; and                         cannot take effect until 60 days after it               PART 52—APPROVAL AND
                                                   • Does not provide EPA with the                        is published in the Federal Register.                   PROMULGATION OF
                                                discretionary authority to address, as                    This action is not a ‘‘major rule’’ as                  IMPLEMENTATION PLANS
                                                appropriate, disproportionate human                       defined by 5 U.S.C. 804(2).
                                                health or environmental effects, using                                                                            ■ 1. The authority citation for part 52
                                                practicable and legally permissible                          Under section 307(b)(1) of the CAA,
                                                                                                          petitions for judicial review of this                   continues to read as follows:
                                                methods, under Executive Order 12898
                                                (59 FR 7629, February 16, 1994).                          action must be filed in the United States                   Authority: 42 U.S.C. 7401 et seq.
                                                   In addition, the SIP is not approved                   Court of Appeals for the appropriate
                                                to apply on any Indian reservation land                   circuit by January 27, 2017. Filing a                   Subpart RR—Tennessee
                                                or in any other area where EPA or an                      petition for reconsideration by the
                                                Indian tribe has demonstrated that a                      Administrator of this final rule does not               ■  2. In § 52.2220, the table in paragraph
                                                tribe has jurisdiction. In those areas of                 affect the finality of this action for the              (e) is amended by adding the entry
                                                Indian country, the rule does not have                    purposes of judicial review nor does it                 ‘‘110(a)(1) and (2) Infrastructure
                                                tribal implications as specified by                       extend the time within which a petition                 Requirements for the 2010 1-hour SO2
                                                Executive Order 13175 (65 FR 67249,                       for judicial review may be filed, and                   NAAQS’’ at the end of the table to read
                                                November 9, 2000), nor will it impose                     shall not postpone the effectiveness of                 as follows:
                                                substantial direct costs on tribal                        such rule or action. This action may not
                                                                                                                                                                  § 52.2220     Identification of plan.
                                                governments or preempt tribal law.                        be challenged later in proceedings to
                                                   The Congressional Review Act, 5                        enforce its requirements. See section                   *       *    *        *       *
                                                U.S.C. 801 et seq., as added by the Small                 307(b)(2).                                                  (e) * * *
                                                                                         EPA-APPROVED TENNESSEE NON-REGULATORY PROVISIONS
                                                                                                     Applicable geo-          State effective
                                                  Name of non-regulatory SIP provision               graphic or non-                                EPA approval date                       Explanation
                                                                                                                                   date
                                                                                                     attainment area


                                                        *                   *                             *                        *                            *                  *                       *
                                                110 (a)(1) and (2) Infrastructure Re-              Tennessee .............     03/13/2014           11/28/16, [insert      With the exception of interstate trans-
                                                  quirements for the 2010 1-hour SO2                                                                  Federal Register      port     requirements       of   section
                                                  NAAQS.                                                                                              citation].            110(a)(2)(D)(i)(I) and (II) (prongs 1, 2,
                                                                                                                                                                            and 4).



                                                [FR Doc. 2016–28429 Filed 11–25–16; 8:45 am]              SUMMARY:   On September 14, 2015, the                   day (g/day) based on national surveys.
                                                BILLING CODE 6560–50–P                                    Environmental Protection Agency (EPA)                   The best available data now
                                                                                                          proposed revisions to the federal Clean                 demonstrate that fish consumers in
                                                                                                          Water Act (CWA) human health criteria                   Washington consume much more fish
                                                ENVIRONMENTAL PROTECTION                                  applicable to waters under the State of                 than 6.5 g/day. There are also new data
                                                AGENCY                                                    Washington’s jurisdiction to ensure that                and scientific information available to
                                                                                                          the criteria are set at levels that will                update the toxicity and exposure
                                                40 CFR Part 131                                           adequately protect Washington                           parameters used to calculate human
                                                [EPA–HQ–OW–2015–0174; FRL–9955–40–                        residents, including tribes with treaty-                health criteria. On August 1, 2016, the
                                                OW]                                                       reserved rights, from exposure to toxic                 State of Washington adopted and
                                                                                                          pollutants. EPA promulgated                             submitted human health criteria for
                                                RIN 2040–AF56                                             Washington’s previous criteria for the                  certain pollutants, reflecting some of
                                                                                                          protection of human health in 1992 as                   these new data and information.
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                                                Revision of Certain Federal Water                         part of the National Toxics Rule (NTR)                  Concurrent with this final rule, EPA is
                                                Quality Criteria Applicable to                            (amended in 1999 for Polychlorinated                    taking action under CWA 303(c) to
                                                Washington                                                Biphenyls (PCBs)), using the Agency’s                   approve in part, and disapprove in part,
                                                AGENCY:  Environmental Protection                         recommended criteria values at the                      the human health criteria submitted by
                                                Agency (EPA).                                             time. EPA derived those previously                      Washington. For those criteria that EPA
                                                                                                          applicable criteria using a fish                        disapproved, EPA is finalizing federal
                                                ACTION: Final rule.
                                                                                                          consumption rate (FCR) of 6.5 grams per                 human health criteria in this final rule.


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                                                85418               Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                EPA is not finalizing criteria in this final                     I. General Information                                  G. Executive Order 13045 (Protection of
                                                rule for those state-adopted criteria that                          A. Does this action apply to me?                        Children From Environmental Health
                                                EPA approved, or for certain criteria                               B. How did EPA develop this final rule?                 and Safety Risks)
                                                that EPA has determined involve                                  II. Background                                          H. Executive Order 13211 (Actions That
                                                scientific uncertainty, as explained                                A. Statutory and Regulatory Background                  Significantly Affect Energy Supply,
                                                                                                                    B. EPA’s CWA 303(c) Action on                           Distribution, or Use)
                                                below.
                                                                                                                       Washington’s Human Health Criteria                I. National Technology Transfer and
                                                DATES: This final rule is effective on                              C. General Recommended Approach for
                                                                                                                                                                            Advancement Act of 1995
                                                December 28, 2016.                                                     Deriving Human Health Criteria
                                                                                                                                                                         J. Executive Order 12898 (Federal Actions
                                                ADDRESSES: EPA has established a                                 III. Derivation of Human Health Criteria for
                                                                                                                       Washington                                           To Address Environmental Justice in
                                                docket for this action under Docket ID                                                                                      Minority Populations and Low-Income
                                                No. EPA–HQ–OW–2015–0174. All                                        A. Scope of Pollutants and Waters Covered
                                                                                                                       by This Final Rule                                   Populations)
                                                documents in the docket are listed on                                                                                    K. Congressional Review Act (CRA)
                                                                                                                    B. Washington’s Designated Uses and
                                                the http://www.regulations.gov Web                                     Tribal Reserved Fishing Rights
                                                site. Although listed in the index, some                                                                               I. General Information
                                                                                                                    C. Washington-Specific Human Health
                                                information is not publicly available,                                 Criteria Inputs                                 A. Does this action apply to me?
                                                e.g., CBI or other information whose                                D. Final Human Health Criteria for
                                                disclosure is restricted by statute.                                   Washington                                        Entities such as industries,
                                                Certain other material, such as                                     E. Applicability of Criteria                       stormwater management districts, or
                                                copyrighted material, is not placed on                              F. Alternative Regulatory Approaches and           publicly owned treatment works
                                                the Internet and will be publicly                                      Implementation Mechanisms                       (POTWs) that discharge pollutants to
                                                available only in hard copy form.                                IV. Economic Analysis
                                                                                                                    A. Identifying Affected Entities
                                                                                                                                                                       waters of the United States under the
                                                Publicly available docket materials are                                                                                State of Washington’s jurisdiction could
                                                available electronically through http://                            B. Method for Estimating Costs
                                                                                                                    C. Results                                         be indirectly affected by this
                                                www.regulations.gov.                                                                                                   rulemaking, because federal water
                                                                                                                 V. Statutory and Executive Order Reviews
                                                FOR FURTHER INFORMATION CONTACT:                                    A. Executive Order 12866 (Regulatory               quality standards (WQS) promulgated
                                                Erica Fleisig, Office of Water, Standards                              Planning and Review) and Executive              by EPA are applicable to CWA
                                                and Health Protection Division (4305T),                                Order 13563 (Improving Regulation and           regulatory programs, such as National
                                                Environmental Protection Agency, 1200                                  Regulatory Review)                              Pollutant Discharge Elimination System
                                                Pennsylvania Avenue NW., Washington,                                B. Paperwork Reduction Act
                                                                                                                                                                       (NPDES) permitting. Citizens concerned
                                                DC 20460; telephone number: (202)                                   C. Regulatory Flexibility Act
                                                                                                                    D. Unfunded Mandates Reform Act                    with water quality in Washington could
                                                566–1057; email address: fleisig.erica@                                                                                also be interested in this rulemaking.
                                                                                                                    E. Executive Order 13132 (Federalism)
                                                epa.gov.                                                                                                               Categories and entities that could
                                                                                                                    F. Executive Order 13175 (Consultation
                                                SUPPLEMENTARY INFORMATION: This final                                  and Coordination With Indian Tribal             potentially be affected include the
                                                rule is organized as follows:                                          Governments)                                    following:

                                                                   Category                                                               Examples of potentially affected 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                                 September 14, 2015.1 On October 28,                   issues. EPA also received over 400
                                                exhaustive, but rather provides a guide                          2015, in response to stakeholder                      letters from individuals associated with
                                                for readers regarding entities that could                        requests,2 EPA extended the public                    mass letter writing campaigns. Some
                                                be indirectly affected by this action.                           comment period for an additional 45                   comments addressed issues beyond the
                                                Any parties or entities who depend                               days.3 In addition, EPA held two virtual              scope of the rulemaking, and thus EPA
                                                upon or contribute to the water quality                          public hearings on December 15th and                  did not consider them in finalizing this
                                                of Washington’s waters could be                                  16th, 2015, to discuss the contents of                rule. In each section of this preamble,
                                                indirectly affected by this rule. To                             the proposed rule and accept verbal                   EPA discusses certain public comments
                                                determine whether your facility or                               public comments.                                      so that the public is aware of the
                                                activities could be indirectly affected by                         Over 60 organizations and individuals               Agency’s position. For a full response to
                                                this action, you should carefully                                submitted comments on a range of                      these and all other comments, see EPA’s
                                                examine this rule. If you have questions                                                                               Response to Comments document in the
                                                                                                                   1 See Revision of Certain Federal Water Quality
                                                regarding the applicability of this action                                                                             official public docket.
                                                                                                                 Criteria Applicable to Washington: Proposed Rule,
                                                to a particular entity, consult the person                       80 FR 55063, September 14, 2015.                      II. Background
                                                listed in the FOR FURTHER INFORMATION                              2 EPA received requests from the Association of

                                                CONTACT section.                                                 Washington Business—Washington State’s Chamber        A. Statutory and Regulatory Background
                                                                                                                 of Commerce, Washington Public Ports Association
                                                B. How did EPA develop this final rule?                          (on behalf of the Association of Washington Cities      CWA section 101(a)(2) establishes as
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                                                                                                                 and the Washington State Association of Counties),
                                                  In developing this final rule, EPA                             Western Wood Preservers Institute, ALCOA,
                                                                                                                                                                       a national goal ‘‘water quality which
                                                carefully considered the public                                  American Forest and Paper Association, McFarland      provides for the protection and
                                                comments and feedback received from                              Cascade, Schnitzer Steel Industries, and              propagation of fish, shellfish, and
                                                interested parties. EPA originally                               Weyerhaeuser.                                         wildlife, and recreation in and on the
                                                                                                                   3 See Extension of Public Comment Period for the
                                                provided a 60-day public comment                                 Revision of Certain Federal Water Quality Criteria
                                                                                                                                                                       water, wherever attainable.’’ These are
                                                period after publishing the proposed                             Applicable to Washington, 80 FR 65980, October        commonly referred to as the ‘‘fishable/
                                                rule in the Federal Register on                                  28, 2015.                                             swimmable’’ goals of the CWA. EPA


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                                                                 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                                  85419

                                                interprets ‘‘fishable’’ uses to include, at             particular pollutants to protect the CWA              with CWA section 303(c)(3) and (c)(4)
                                                a minimum, designated uses providing                    section 101(a)(2) goal uses. In 2015, EPA             requirements.7 After the effective date of
                                                for the protection of aquatic                           updated its 304(a) recommended criteria               this final rule, these federal criteria will
                                                communities and human health related                    for human health for 94 pollutants.5                  be in effect for CWA purposes along
                                                to consumption of fish and shellfish.4                  Where EPA has published                               with the human health criteria that
                                                  CWA section 303(c) (33 U.S.C.                         recommended criteria, states should                   Washington adopted and EPA approved.
                                                1313(c)) directs states to adopt WQS for                establish numeric water quality criteria                Several commenters provided
                                                their waters subject to the CWA. CWA                    based on EPA’s CWA section 304(a)                     comments on the timing of EPA’s rule,
                                                section 303(c)(2)(A) and EPA’s                          criteria, section 304(a) criteria modified            and the relationship between EPA’s
                                                implementing regulations at 40 CFR part                 to reflect site-specific conditions, or               federal rulemaking and the state
                                                131 require, among other things, that a                 other scientifically defensible methods               rulemaking process. These comments
                                                state’s WQS specify appropriate                         (40 CFR 131.11(b)(1)). In all cases                   are now, for the most part, mooted by
                                                designated uses of the waters, and water                criteria must be sufficient to protect the            EPA’s finalization of its federal rule and
                                                quality criteria that protect those uses.               designated use and be based on sound                  action on the state’s submittal. For
                                                EPA’s regulations at 40 CFR 131.11(a)(1)                scientific rationale (40 CFR                          additional responses to specific
                                                provide that ‘‘[s]uch criteria must be                  131.11(a)(1)). CWA section 303(c)(2)(B)               comments, see EPA’s Response to
                                                based on sound scientific rationale and                 requires states to adopt numeric criteria             Comment document in the docket for
                                                must contain sufficient parameters or                   for all toxic pollutants listed pursuant to           this rule.
                                                constituents to protect the designated                  CWA section 307(a)(1) for which EPA
                                                use. For waters with multiple use                       has published 304(a) criteria, as                     C. General Recommended Approach for
                                                designations, the criteria shall support                necessary to support the states’                      Deriving Human Health Criteria
                                                the most sensitive use.’’ In addition, 40               designated uses.                                         Human health criteria are designed to
                                                CFR 131.10(b) provides that ‘‘[i]n                        In 1992, EPA promulgated the NTR at                 minimize the risk of adverse cancer and
                                                designating uses of a water body and the                40 CFR 131.36, establishing chemical-                 non-cancer effects occurring from
                                                appropriate criteria for those uses, the                specific numeric criteria for 85 priority             lifetime exposure to pollutants through
                                                state shall take into consideration the                 toxic pollutants for 14 states and                    the ingestion of drinking water and
                                                water quality standards of downstream                   territories (states), including                       consumption of fish and shellfish
                                                waters and ensure that its water quality                Washington, that were not in                          obtained from inland and nearshore
                                                standards provide for the attainment                    compliance with the requirements of                   waters (by nearshore waters, EPA refers
                                                and maintenance of the water quality                    CWA section 303(c)(2)(B). When states                 to waters out to three miles from the
                                                standards of downstream waters.’’                       covered by the NTR subsequently                       coast). EPA’s practice is to establish a
                                                  States are required to review                         adopted their own criteria for toxic                  human health 304(a) recommended
                                                applicable WQS at least once every                      pollutants that EPA approved as                       criterion for both drinking water and
                                                three years and, if appropriate, revise or              consistent with the CWA and EPA’s                     consumption of fish and shellfish from
                                                adopt new standards (CWA section                        implementing regulations, EPA                         inland and nearshore waters combined,
                                                303(c)(1)). Any new or revised WQS                      amended the NTR to remove those                       and a separate human health criterion
                                                must be submitted to EPA for review                     criteria for those states.                            based only on ingestion of fish and
                                                and approval or disapproval (CWA                                                                              shellfish from inland and nearshore
                                                section 303(c)(2)(A) and (c)(3)). If EPA                B. EPA’s CWA 303(c) Action on
                                                                                                        Washington’s Human Health Criteria                    waters. This latter criterion applies in
                                                disapproves a state’s new or revised                                                                          cases where the designated uses of a
                                                WQS, the CWA provides the state 90                         On September 14, 2015, EPA made a                  waterbody include supporting fish and
                                                days to adopt a revised WQS that meets                  CWA 303(c)(4)(B) determination that                   shellfish for human consumption but
                                                CWA requirements, and if it fails to do                 new or revised WQS for the protection                 not drinking water supply sources (e.g.,
                                                so, EPA shall promptly propose and                      of human health in Washington were                    in non-potable estuarine waters).
                                                then within 90 days promulgate such                     necessary to meet the requirements of                    The criteria are based on two types of
                                                standard unless EPA approves a state                    the CWA, and proposed revised human                   biological endpoints: (1) Carcinogenicity
                                                replacement WQS first (CWA section                      health criteria for the state (see 80 FR              and (2) systemic toxicity (i.e., all
                                                303(c)(3) and (c)(4)(A)). CWA section                   55063). At that time, Washington had                  adverse effects other than cancer). EPA
                                                303(c)(4)(B) authorizes the                             not yet adopted its own criteria for the              takes an integrated approach and
                                                Administrator to determine that a new                   protection of human health.6 On August                considers both cancer and non-cancer
                                                or revised standard is needed to meet                   1, 2016, Washington adopted and                       effects when deriving human health
                                                CWA requirements. Upon making such                      submitted statewide human health                      criteria. Where sufficient data are
                                                a determination, the CWA specifies that                 criteria and new and revised                          available, EPA derives criteria using
                                                EPA shall promptly propose, and then                    implementation provisions. Concurrent
                                                within 90 days promulgate, any such                     with this final rule, EPA approved 45                    7 EPA is finalizing a different number of human
                                                new or revised standard unless prior to                 and disapproved 143 of Washington’s                   health criteria (144) than it is disapproving (143) in
                                                such promulgation, the state has                        human health criteria under CWA                       Washington’s 2016 submittal. Washington did not
                                                adopted a revised or new WQS that EPA                   303(c). EPA is finalizing 144 human                   adopt organism-only criteria for methylmercury or
                                                                                                                                                              water-plus-organism and organism-only criteria for
                                                determines to be in accordance with the                 health criteria in this rule in accordance            bis(2-chloro-1-methylethyl) ether. These are priority
                                                CWA.                                                                                                          pollutants listed pursuant to CWA section 307(a)(1)
                                                  Under CWA section 304(a), EPA                           5 Final Updated Ambient Water Quality Criteria
                                                                                                                                                              for which EPA has 304(a) recommended criteria,
                                                periodically publishes criteria                         for the Protection of Human Health, (80 FR 36986,     and, as such, CWA section 303(c)(2)(B) requires that
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                                                                                                        June 29, 2015). See also: USEPA. 2015. Final 2015     states adopt numeric criteria for these pollutants, as
                                                recommendations for states to consider                  Updated National Recommended Human Health             necessary to support the states’ designated uses.
                                                when adopting water quality criteria for                Criteria. U.S. Environmental Protection Agency,       Therefore, EPA is including these three criteria in
                                                                                                        Office of Water, Washington, DC https://              this final rule for Washington. This final rule,
                                                  4 USEPA. 2000. Memorandum #WQSP–00–03.                www.epa.gov/wqc/human-health-water-quality-           however, does not include revised water-plus-
                                                U.S. Environmental Protection Agency, Office of         criteria.                                             organism and organism-only criteria for arsenic, as
                                                Water, Washington, DC https://www.epa.gov/sites/          6 Washington adopted criteria for the protection    explained below in section III.A, even though EPA
                                                production/files/2015-01/documents/standards-           of aquatic life from toxic pollutants at WAC 173–     is disapproving the arsenic criteria in Washington’s
                                                shellfish.pdf.                                          201A–240.                                             submittal.



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                                                85420            Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                both carcinogenic and non-carcinogenic                      If the pollutant is not considered to              consumption of fish and shellfish from
                                                toxicity endpoints and recommends the                     have the potential for causing cancer in             inland and nearshore waters, multiplied
                                                lower value. Human health criteria for                    humans (i.e., systemic toxicants), EPA               by pollutant-specific bioaccumulation
                                                carcinogenic effects are calculated using                 assumes that the pollutant has a                     factors (BAFs) to account for the amount
                                                the following input parameters: Cancer                    threshold (the RfD) below which a                    of the pollutant in the edible portions of
                                                slope factor (CSF), cancer risk level,                    physiological mechanism exists to avoid              the ingested species. EPA’s 2000
                                                body weight, drinking water intake rate,                  or overcome the adverse effects of the               Methodology for deriving human health
                                                fish consumption rate, and a                              pollutant.                                           criteria emphasizes using, when
                                                bioaccumulation factor(s). Human                                                                               possible, measured or estimated BAFs,
                                                                                                          b. Cancer Slope Factor and Reference
                                                health criteria for non-carcinogenic and                                                                       which account for chemical
                                                                                                          Dose
                                                nonlinear carcinogenic effects are                                                                             accumulation in aquatic organisms from
                                                calculated using a reference dose (RfD)                      A dose-response assessment is                     all potential exposure routes.13 In the
                                                in place of a CSF and cancer risk level,                  required to understand the quantitative              2015 national 304(a) human health
                                                and a relative source contribution (RSC)                  relationships between exposure to a                  criteria update, EPA primarily used
                                                factor, which is intended to ensure that                  pollutant and the onset of human health              field-measured BAFs, and laboratory-
                                                an individual’s total exposure to a given                 effects. EPA evaluates dose-response                 measured bioconcentration factors
                                                pollutant from all sources does not                       relationships derived from animal                    (BCFs) with applicable food chain
                                                exceed the RfD. Each of these inputs is                   toxicity and human epidemiological                   multipliers available from peer-
                                                discussed in more detail below and in                     studies to derive dose-response metrics.             reviewed, publicly available databases,
                                                EPA’s 2000 Human Health Methodology                       For carcinogenic toxicological effects,              to develop national BAFs for three
                                                (hereafter referred to as EPA’s ‘‘2000                    EPA uses an oral CSF to derive human                 trophic levels of fish. If this information
                                                Methodology’’).8                                          health criteria. The oral CSF is an upper            was not available, EPA selected octanol-
                                                                                                          bound, approximating a 95 percent                    water partition coefficients (Kow values)
                                                a. Cancer Risk Level                                      confidence limit, on the increased                   from peer-reviewed sources for use in
                                                                                                          cancer risk from a lifetime oral exposure            calculating national BAFs.14
                                                   EPA’s 304(a) national recommended                      to a stressor. For non-carcinogenic                     EPA’s national default drinking water
                                                human health criteria are typically                       effects, EPA uses the RfD to calculate               intake rate of 2.4 L/day represents the
                                                based on the assumption that                              human health criteria. A RfD is an                   per capita estimate of combined direct
                                                carcinogenicity is a ‘‘non-threshold                      estimate of a daily oral exposure of an              and indirect community water ingestion
                                                phenomenon,’’ which means that there                      individual to a substance that is likely             at the 90th percentile for adults ages 21
                                                are no ‘‘no-effect’’ levels, because even                 to be without an appreciable risk of                 and older.15 EPA’s national default FCR
                                                extremely small doses are assumed to                      deleterious effects during a lifetime. A             of 22 g/day represents the 90th
                                                cause a finite increase in the incidence                  RfD is typically derived from a                      percentile consumption rate of fish and
                                                of cancer. Therefore, EPA calculates                      laboratory animal dosing study in which              shellfish from inland and nearshore
                                                304(a) human health criteria for                          a no-observed-adverse-effect level                   waters for the U.S. adult population 21
                                                carcinogenic effects as pollutant                         (NOAEL), lowest-observed-adverse-                    years of age and older, based on
                                                concentrations corresponding to lifetime                  effect level (LOAEL), or benchmark dose              National Health and Nutrition
                                                increases in the risk of developing                       can be obtained. Uncertainty factors are             Examination Survey (NHANES) data
                                                cancer.9 EPA calculates its 304(a)                        applied to reflect the limitations of the            from 2003 to 2010.16 17 EPA calculates
                                                human health criteria values at a 10¥6                    data. EPA’s Integrated Risk Information
                                                (one in one million) cancer risk level                    System (IRIS) 11 was the primary source                 13 USEPA. 2000. Methodology for Deriving

                                                and recommends cancer risk levels of                      of toxicity values (i.e., RfD and CSF) for           Ambient Water Quality Criteria for the Protection
                                                10¥6 or 10¥5 (one in one hundred                                                                               of Human Health. U.S. Environmental Protection
                                                                                                          EPA’s 2015 updated 304(a) human                      Agency, Office of Water, Washington, DC EPA–822–
                                                thousand) for the general population.10                   health criteria.12 For some pollutants,              B–00–004. https://www.epa.gov/wqc/human-
                                                EPA notes that states and authorized                      however, more recent peer-reviewed                   health-water-quality-criteria.
                                                tribes can also choose a more stringent                   and publicly available toxicological data
                                                                                                                                                                  14 Final Updated Ambient Water Quality Criteria

                                                risk level, such as 10¥7 (one in ten                                                                           for the Protection of Human Health, (80 FR 36986,
                                                                                                          were available from other EPA program                June 29, 2015). See also: USEPA. 2015. Final 2015
                                                million), when deriving human health                      offices (e.g., Office of Pesticide                   Updated National Recommended Human Health
                                                criteria.                                                 Programs, Office of Water, Office of                 Criteria. U.S. Environmental Protection Agency,
                                                                                                                                                               Office of Water, Washington, DC https://
                                                                                                          Land and Emergency Management),                      www.epa.gov/wqc/human-health-water-quality-
                                                   8 USEPA. 2000. Methodology for Deriving
                                                                                                          other national and international                     criteria.
                                                Ambient Water Quality Criteria for the Protection
                                                of Human Health. U.S. Environmental Protection
                                                                                                          programs, and state programs.                           15 USEPA. 2011. EPA Exposure Factors

                                                                                                                                                               Handbook. 2011 edition (EPA 600/R–090/052F).
                                                Agency, Office of Water, Washington, DC EPA–822–          c. Exposure Assumptions                              http://cfpub.epa.gov/ncea/risk/
                                                B–00–004. https://www.epa.gov/wqc/human-
                                                                                                                                                               recordisplay.cfm?deid=236252.
                                                health-water-quality-criteria.                               EPA’s latest 304(a) national human                   16 USEPA. 2014. Estimated Fish Consumption
                                                   9 As noted above, EPA recommends the criterion
                                                                                                          health criteria use a default drinking               Rates for the U.S. Population and Selected
                                                derived for non-carcinogenic effects if it is more        water intake rate of 2.4 liters per day (L/          Subpopulations (NHANES 2003–2010). United
                                                protective (lower) than that derived for carcinogenic                                                          States Environmental Protection Agency,
                                                effects.                                                  day) and default rate of 22 g/day for
                                                                                                                                                               Washington, DC EPA 820–R–14–002.
                                                   10 EPA’s 2000 Methodology also states: ‘‘Criteria
                                                                                                                                                                  17 EPA’s national FCR is based on the total rate
                                                                                                             11 USEPA. Integrated Risk Information System
                                                based on a 10¥5 risk level are acceptable for the                                                              of consumption of fish and shellfish from inland
                                                general population as long as states and authorized       (IRIS). U.S. Environmental Protection Agency,        and nearshore waters (including fish and shellfish
                                                tribes ensure that the risk to more highly exposed        Office of Research and Development, Washington,      from local, commercial, aquaculture, interstate, and
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                                                subgroups (sport fishers or subsistence fishers) does     DC www.epa.gov/iris.                                 international sources). This is consistent with a
                                                not exceed the 10¥4 level.’’ Since EPA is                    12 Final Updated Ambient Water Quality Criteria
                                                                                                                                                               principle that each state does its share to protect
                                                establishing final criteria to protect a target general   for the Protection of Human Health, (80 FR 36986,    people who consume fish and shellfish that
                                                population of tribes with reserved subsistence            June 29, 2015). See also: USEPA. 2015. Final 2015    originate from multiple jurisdictions. USEPA.
                                                fishing rights in Washington waters, the applicable       Updated National Recommended Human Health            January 2013. Human Health Ambient Water
                                                EPA-recommended cancer risk levels would relate           Criteria. U.S. Environmental Protection Agency,      Quality Criteria and Fish Consumption Rates:
                                                to that target general population, as opposed to the      Office of Water, Washington, DC https://             Frequently Asked Questions. https://www.epa.gov/
                                                general population of Washington residents overall.       www.epa.gov/wqc/human-health-water-quality-          wqc/human-health-ambient-water-quality-criteria-
                                                See section III for additional discussion.                criteria.                                            and-fish-consumption-rates-frequently-asked.



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                                                                 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                               85421

                                                human health criteria using a default                   exposure from all sources does not                    priority toxic pollutants such as arsenic
                                                body weight of 80 kilograms (kg), the                   exceed that threshold level. These other              and dioxin. Given the scientific
                                                average weight of a U.S. adult age 21                   exposures include exposure to a                       uncertainty regarding aspects of the
                                                and older, based on NHANES data from                    particular pollutant from ocean fish and              science upon which the proposed
                                                1999 to 2006.                                           shellfish consumption (which is not                   human health criteria for arsenic,
                                                   Although EPA uses these default                      included in EPA’s default national                    dioxin, and thallium were based, EPA is
                                                values to calculate national 304(a)                     FCR), non-fish food consumption (e.g.,                withdrawing its proposal of revised
                                                recommended human health criteria,                      fruits, vegetables, grains, meats,                    criteria for these three pollutants at this
                                                EPA’s 2000 Methodology notes a                          poultry), dermal exposure, and                        time and leaving the existing criteria
                                                preference for the use of local data to                 inhalation exposure. EPA’s guidance                   from the NTR in effect for CWA
                                                calculate human health criteria (e.g.,                  includes a procedure for determining an               purposes.22 EPA did not update the
                                                locally derived FCRs, drinking water                    appropriate RSC value ranging from 0.2                304(a) national recommended criteria
                                                intake rates and body weights, and                      to 0.8 for a given pollutant.                         for these three pollutants in 2015. As
                                                waterbody-specific bioaccumulation                                                                            noted earlier, IRIS was the primary
                                                rates) over national default values,                    III. Derivation of Human Health                       source of toxicity values (i.e., RfD and
                                                where data are sufficient to do so, to                  Criteria for Washington                               CSF) for EPA’s 2015 updated 304(a)
                                                better represent local conditions.18 It is              A. Scope of Pollutants and Waters                     human health criteria. For thallium,
                                                also important, where sufficient data are               Covered by This Final Rule                            EPA’s IRIS database does not currently
                                                available, to select a FCR that reflects                                                                      contain an estimate of thallium’s
                                                consumption that is not suppressed by                      In 1992, EPA did not establish human
                                                                                                        health criteria in the NTR for some                   toxicity (i.e., a RfD).23 For dioxin, IRIS
                                                concerns about the safety of available                                                                        does not currently contain a measure of
                                                fish.19 20 Deriving human health criteria               priority toxic pollutants because, as
                                                                                                        stated in the preamble to the final rule              dioxin’s cancer-causing ability (i.e., a
                                                using an unsuppressed FCR furthers the                                                                        CSF).24 Without such values, EPA has
                                                restoration goals of the CWA and                        at 57 FR 60848, December 22, 1992, EPA
                                                                                                        had no 304(a) recommendations for                     concluded that further analysis is
                                                ensures protection of human health-                                                                           necessary in order to promulgate
                                                related designated uses (as pollutant                   those pollutants at the time. EPA now
                                                                                                        has 304(a) recommendations for 99                     scientifically sound revised criteria for
                                                levels decrease, fish habitats are                                                                            these two pollutants. For arsenic, there
                                                restored, and fish availability increases               priority toxic pollutants listed pursuant
                                                                                                        to CWA section 307(a)(1) (85 for which                is uncertainty surrounding the
                                                over time). See section III for additional                                                                    toxicological assessment with respect to
                                                discussion regarding use of an                          EPA established criteria in the NTR,
                                                                                                        plus 14 additional pollutants).                       human health effects. EPA’s current
                                                unsuppressed FCR to protect a                                                                                 plan for addressing the arsenic issues is
                                                                                                           After consideration of all comments
                                                subsistence or sustenance fishing use,                                                                        described in the Assessment
                                                                                                        received on EPA’s proposed rule, and
                                                especially where the subsistence or                                                                           Development Plan for the Integrated
                                                                                                        EPA’s CWA 303(c) action on
                                                sustenance use is based in whole or in                                                                        Risk Information System (IRIS)
                                                                                                        Washington’s submittal, EPA is
                                                part on tribal treaty or other reserved                                                                       Toxicological Review of Inorganic
                                                                                                        finalizing 144 new and revised
                                                fishing rights.21                                                                                             Arsenic (EPA/630/R–14/101, November
                                                                                                        Washington-specific criteria for priority
                                                d. Relative Source Contribution                         toxic pollutants in this rule. For arsenic,           2015). EPA intends to reevaluate the
                                                                                                        dioxin and thallium, EPA is not revising              existing federal arsenic, dioxin and
                                                   When deriving human health criteria                                                                        thallium human health criteria for
                                                for non-carcinogens and nonlinear                       Washington’s existing criteria from the
                                                                                                        NTR at this time, as explained below                  Washington by 2018, with particular
                                                carcinogens, EPA recommends                                                                                   consideration of any relevant toxicity
                                                including a RSC factor to account for                   and in EPA’s Response to Comments
                                                                                                        document in the docket for the final                  and bioaccumulation information.
                                                sources of exposure other than drinking                                                                          This rule revises the criteria that EPA
                                                water and fish and shellfish from inland                rule. For those priority pollutants for
                                                                                                        which EPA does not have 304(a)                        promulgated for Washington in the NTR
                                                and nearshore waters, so that the                                                                             (with the exception of criteria for
                                                pollutant effect threshold (i.e., RfD) is               national recommended criteria, and are
                                                                                                        therefore not included in Washington’s                arsenic, dioxin, and thallium, and
                                                not apportioned to drinking water and                                                                         criteria that EPA approved in
                                                fish consumption alone. The rationale                   submittal or this final rule, EPA expects
                                                                                                        that Washington will continue to apply                Washington’s August 1, 2016 submittal),
                                                for this approach is that for pollutants                                                                      and establishes new human health
                                                exhibiting threshold effects, the                       its existing narrative toxics criterion in
                                                                                                        the state’s WQS at WAC 173–201A–                      criteria for 8 additional chemicals for
                                                objective of the human health criteria is                                                                     which EPA now has 304(a)
                                                to ensure that an individual’s total                    260(2)(a).
                                                                                                           Several commenters raised concerns                 recommended criteria (and for which
                                                                                                        about the scientific defensibility of                 EPA did not approve Washington’s
                                                   18 USEPA. 2000. Methodology for Deriving

                                                Ambient Water Quality Criteria for the Protection       EPA’s proposed human health criteria                  submitted criteria): Selenium, Zinc, 1,2-
                                                of Human Health. U.S. Environmental Protection          for arsenic, and one commenter raised                 Trans-Dichloroethylene, Acenaphthene,
                                                Agency, Office of Water, Washington, DC EPA–822–        similar concerns about EPA’s proposed                 Butylbenzyl Phthalate, 2-
                                                B–00–004. https://www.epa.gov/wqc/human-                                                                      Chloronaphthalene, 1,1,1-
                                                health-water-quality-criteria.                          criteria for 2,3,7,8–TCDD (dioxin).
                                                   19 USEPA. January 2013. Human Health Ambient         Additionally, after EPA proposed                      Trichloroethane, and 1,2,4-
                                                Water Quality Criteria and Fish Consumption Rates:      revised human health criteria for                     Trichlorobenzene. In 2001, EPA
                                                Frequently Asked Questions. https://www.epa.gov/        thallium in Washington, EPA further
                                                wqc/human-health-ambient-water-quality-criteria-                                                                22 EPA is moving Washington’s existing arsenic,

                                                and-fish-consumption-rates-frequently-asked.
                                                                                                        evaluated the scientific uncertainty                  dioxin and thallium criteria from the NTR into 40
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                                                   20 National Environmental Justice Advisory           around the appropriate RfD for thallium.              CFR 131.45 to have one comprehensive human
                                                Council, Fish Consumption and Environmental             EPA carefully considered all of these                 health criteria rule for Washington.
                                                Justice, p.44 (2002) available at https://              comments and information regarding                      23 http://cfpub.epa.gov/ncea/iris/index.cfm

                                                www.epa.gov/sites/production/files/2015-02/             these three pollutants, along with the                ?fuseaction=iris.showQuickView&substance_
                                                documents/fish-consump-report_1102.pdf.                                                                       nmbr=1012.
                                                   21 The term ‘‘subsistence’’ is coterminous with      comments that articulated it is                         24 http://cfpub.epa.gov/ncea/iris/index.cfm

                                                ‘‘sustenance’’ in this context. Hereafter, the          important for Washington to have                      ?fuseaction=iris.showQuickView&substance_
                                                document uses the term ‘‘subsistence.’’                 protective numeric criteria in place for              nmbr=1024.



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                                                85422            Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                replaced its 304(a) recommended                         the purpose of a fish advisory is                       criteria that are scientifically supported
                                                human health criteria for total mercury                 different from the purpose of a water                   and protective of designated uses, in
                                                with a fish tissue-based human health                   quality criterion, it will be helpful to the            accordance with the CWA and EPA’s
                                                criterion for methylmercury.25                          public to have water quality criteria and               regulations. In addition, on September
                                                Washington did not include human                        fish consumption advisories for                         29, 2016, EPA published an Advanced
                                                health criteria for mercury or                          methylmercury expressed using the                       Notice of Proposed Rulemaking in the
                                                methylmercury in its August 1, 2016                     same terms. In response to comments                     Federal Register that seeks input on an
                                                submittal. Therefore, with this final                   regarding implementation of the                         approach that involves EPA
                                                rule, EPA replaces the criteria for total               methylmercury criterion, in 2010, EPA                   promulgating baseline WQS for
                                                mercury that EPA promulgated for                        published the comprehensive Guidance                    reservations that currently have no
                                                Washington in the NTR with a                            for Implementing the January 2001                       CWA-effective WQS, including such
                                                methylmercury fish tissue criterion,                    Methylmercury Water Quality Criterion                   reservations within the State of
                                                based on EPA’s 2001 304(a)                              (EPA 823–R–10–001), to aid states in                    Washington.29
                                                recommendation but adjusted to                          implementing the fish tissue-based
                                                incorporate the 175 g/day FCR that EPA                  methylmercury water quality criterion.                  B. Washington’s Designated Uses and
                                                used to derive revised human health                     EPA is confident that Washington will                   Tribal Reserved Fishing Rights
                                                criteria in Washington, as well as EPA’s                be able to implement the fish tissue                    a. EPA’s Consideration of Tribal Treaty
                                                2015 updated national default body                      criterion using the information                         Rights
                                                weight of 80 kg.                                        contained in that document, and EPA
                                                   A few commenters expressed concern                   remains available to offer assistance in                   Under the Supremacy Clause of the
                                                that Washington would not have the                      doing so. Thus there is no need or                      U.S. Constitution, federal treaties have
                                                data or implementation guidance to                      requirement to leave the NTR total                      the same legal force as federal statutes.30
                                                properly implement a fish tissue                        mercury criteria in place in Washington.                As such, the provisions of federal
                                                criterion for methylmercury, and                           This final rule does not change or                   statutes should generally be read in
                                                requested that EPA leave the NTR total                  supersede any criteria that EPA                         harmony with treaties where they both
                                                mercury criteria in effect in Washington.               previously promulgated for other states                 apply. In certain instances, statutes may
                                                The fish tissue methylmercury criterion                 in the NTR, nor does it change any other                contain provisions indicating that they
                                                reflects EPA’s 2000 Methodology, the                    elements of the NTR such as EPA’s                       must be read in harmony with treaties.
                                                best available science, and supersedes                  original basis for promulgation. For                    Such is the case with the CWA, which
                                                all previous 304(a) human health                        clarity in organization, EPA is                         provides that the Act ‘‘shall not be
                                                mercury criteria recommendations                        withdrawing Washington from the NTR                     construed as . . . affecting or impairing
                                                published by EPA (except for the waters                 at 40 CFR 131.36 and incorporating the                  the provisions of any treaty of the
                                                of the Great Lakes System), including                   Washington-specific criteria in this rule               United States.’’ 31
                                                the 304(a) recommended criteria that                    (as well as the existing NTR criteria for                  In determining whether WQS satisfy
                                                served as the basis for the total mercury               arsenic, dioxin and thallium) into 40                   the CWA and EPA’s regulations, and
                                                criteria that EPA promulgated for                       CFR 131.45 so there is a single                         when setting criteria for the protection
                                                Washington in the NTR. EPA                              comprehensive set of federally                          of human health, it is necessary to
                                                recommends a fish tissue water quality                  promulgated criteria for Washington.                    consider other applicable laws, such as
                                                criterion for methylmercury for many                       This rule applies to waters under the                federal treaties (e.g., U.S. Treaties with
                                                reasons. A fish tissue water quality                    State of Washington’s jurisdiction, and                 Indians). While treaties do not expand
                                                criterion integrates spatial and temporal               not to waters within Indian country,27                  EPA’s authority, they are binding on the
                                                complexity that occurs in aquatic                       unless otherwise specified in federal                   federal government. As a result, EPA
                                                systems and affects methylmercury                       law. Some waters located within Indian                  has an obligation to ensure that its
                                                bioaccumulation. For this pollutant, a                  country already have CWA-effective                      actions do not conflict with tribal treaty
                                                fish tissue criterion is more closely tied              human health criteria, while others do                  rights.32 For the foregoing reasons, and
                                                to the goal of protecting human health                  not.28 Several tribes are working with
                                                                                                                                                                   29 For more information, see: https://
                                                because it is based directly on the                     EPA to either revise their existing CWA-
                                                                                                                                                                www.epa.gov/wqs-tech/advance-notice-proposed-
                                                dominant human exposure route for                       effective WQS, or obtain treatment in a                 rulemaking-federal-baseline-water-quality-
                                                methylmercury in the U.S., which is                     similar manner as a state (TAS) status in               standards-indian.
                                                consumption of fish and shellfish. The                  order to adopt CWA-effective WQS in                        30 U.S. Const. art. IV, § 2: The ‘‘Constitution . . .


                                                concentration of methylmercury is also                  the near future. EPA will continue to                   of the United States . . . and all Treaties made, or
                                                                                                        work closely with tribes in Washington                  which shall be made, under the Authority of the
                                                generally easier to quantify in fish tissue                                                                     United States, shall be the supreme Law of the
                                                than in water and is less variable in fish              to ensure that they adopt human health                  Land; and the Judges in every State shall be bound
                                                and shellfish tissue over the time                                                                              thereby, any Thing in the Constitution or Laws of
                                                                                                        protect human health, they represent very different     any State to the Contrary notwithstanding.’’
                                                periods in which WQS are typically                      values and goals. Water quality criteria express or        31 CWA Section 511, 33 U.S.C. 1371.
                                                implemented in water quality-based                      establish a desired condition and must protect the         32 U.S. Const. art. IV, § 2; see United States v.
                                                controls, such as NPDES permits.                        designated use, such as subsistence fishing. Fish       Forty-Three Gallons of Whiskey, 93 U.S. 188, 196
                                                Finally, fish consumption advisories for                consumption advisories start with existing levels of    (1833) (recognizing that ‘‘the Constitution declares
                                                                                                        fish contamination resulting from impaired water        a treaty to be the supreme law of the land,’’ and that
                                                mercury are also based on the amount                    quality, and provide advice to populations              ‘‘a treaty is to be regarded . . . as equivalent to an
                                                of methylmercury in fish tissue.26 While                consuming such fish on limiting levels of               act of the legislature’’) and Worcester v. Georgia, 31
                                                                                                        consumption in order to reduce risk from                U.S. 515, 594 (1832) (‘‘So long as . . . treaties exist,
                                                                                                        contamination.
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                                                  25 USEPA. 2001. Guidance for Implementing the
                                                                                                                                                                having been formed within the sphere of the federal
                                                January 2001 Methylmercury Water Quality                   27 See 18 U.S.C. 1151 for the definition of Indian
                                                                                                                                                                powers, they must be respected and enforced by the
                                                Criterion. U.S. Environmental Protection Agency,        country.                                                appropriate organs of the federal government.’’). See
                                                Office of Water, Washington, DC EPA–823–R–01–              28 Indian country waters with CWA-effective          also EPA policies on considering treaty rights:
                                                001. https://www.epa.gov/wqc/guidance-                  WQS include those where (a) EPA has authorized          Working Effectively With Tribal Governments:
                                                implementing-january-2001-methylmercury-water-          a tribe to adopt WQS under the CWA for its              Resource Guide at pp. 49–52, 53 (August 1998)
                                                quality-criterion.                                      reservation and the tribe has adopted standards that    (explaining the key principles underlying the
                                                  26 While both water quality criteria and fish         EPA has approved, and (b) EPA has promulgated           application of Indian treaty rights, and noting that
                                                consumption advisories are designed ultimately to       federal WQS.                                            ‘‘[f]ederal, state, and local agencies need to refrain



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                                                                 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                                         85423

                                                as further explained below, it is                          purposes.36 In U.S. v Washington, the                      exercise of the treaty-reserved
                                                therefore necessary and appropriate to                     district court made detailed findings of                   subsistence fishing right can be found in
                                                consider tribal treaties to ensure that                    facts regarding the reserved fishing                       heritage FCR reports and contemporary
                                                EPA’s actions under the CWA are in                         right, including the importance of                         FCR surveys (for tables of relevant FCRs,
                                                harmony with such treaties. See also                       subsistence fishing to the treaty tribes:                  see EPA’s Response to Comment
                                                EPA’s Response to Comment document                            At the treaty negotiations, a primary                   document in the docket for this rule).
                                                in the docket for this rule.                               concern of the tribes, whose way of life was                  As explained above, the Stevens-
                                                                                                           so heavily dependent upon harvesting                       Palmer Treaties provide tribes the right
                                                b. Treaty-Reserved Subsistence Fishing                                                                                to exercise subsistence fishing practices
                                                                                                           anadromous fish, was that they have freedom
                                                Rights in Washington                                       to move about to gather food, particularly                 on waters throughout the State of
                                                   The majority of waters under the                        salmon, . . . at their usual and accustomed                Washington. EPA concludes that the
                                                jurisdiction of the State of Washington                    fishing places. . . . Subsequent to the                    purpose for which tribes reserved such
                                                are subject to federal treaties with                       execution of the treaties and in reliance
                                                                                                                                                                      fishing rights through treaties with the
                                                                                                           thereon, the members of the [treaty tribes
                                                tribes.33 There are eight Stevens-Palmer                                                                              U.S. has important implications for
                                                                                                           with reserved fishing rights in Washington]
                                                Treaties relevant to the State of                          have continued to fish for subsistence, sport,             water quality regulation under the
                                                Washington through which 24 tribes                         and commercial purposes at their usual and                 CWA. Fundamentally, the tribes’ ability
                                                reserved for themselves identical or                       accustomed places. Such fishing provided                   to take fish for their subsistence
                                                nearly identical fishing rights within the                 and still provides an important part of their              purposes under the treaties would be
                                                boundaries of present-day Washington;                      livelihood, subsistence and cultural identity.             substantially affected or impaired if it
                                                specifically, the treaty-reserved ‘‘right of               The Indian cultural identification with                    were not supported by water quality
                                                taking fish at usual and accustomed                        fishing is primarily dietary, related to the
                                                                                                           subsistence fishery, and secondarily
                                                                                                                                                                      sufficient under the CWA to ensure that
                                                places, in common with all citizens of                                                                                tribal members can safely eat the fish for
                                                                                                           associated with religious ceremonies and
                                                the Territory.’’ 34 The right to take fish                 commercial fishing.37                                      their own subsistence.
                                                at usual and accustomed places extends                                                                                   Many areas where treaty-reserved
                                                to lands formerly ceded by the tribes to                     Relevant case law, including Supreme                     fishing rights are exercised cannot be
                                                the U.S. as described in the treaties, as                  Court precedents, unequivocally                            directly protected or regulated by tribal
                                                well as to all places beyond the                           confirms that the treaty-reserved right to                 governments to ensure adequate water
                                                boundaries of the ceded territories that                   take fish includes the right to take fish                  quality, and therefore the responsibility
                                                tribal members regularly used at treaty                    for subsistence purposes.38 Historical                     falls to the federal government (and the
                                                time.35                                                    and current evidence of tribal members’                    states) to ensure their protection. It is
                                                   The parties to the treaties all                                                                                    therefore appropriate and necessary for
                                                                                                              36 For a thorough discussion on the treaty
                                                recognized the importance of the fishing                                                                              EPA (and states) to consider the tribal
                                                                                                           negotiation and execution and meaning of the
                                                right for the tribes’ subsistence,                         reserved fishing right, see e.g., U.S. v Washington,       reserved rights within the framework of
                                                ceremonial, as well as commercial                          384 F. Supp. at 348–359 (containing finding of facts       the CWA, to ensure water quality
                                                                                                           regarding, inter alia, treaty status, pre-treaty role of   protection for treaty-reserved
                                                from taking actions that are not consistent with           fishing among northwest Indians, treaty
                                                                                                           background, negotiation and execution of the               subsistence fishing rights. EPA’s
                                                tribal rights wherever they exist’’); Commemorating
                                                the 30th Anniversary of the EPA’s Indian Policy,           treaties, and post-treaty Indian fishing); see also id.    consideration of treaty-reserved fishing
                                                Memorandum from Gina McCarthy to All EPA                   at 340 (‘‘The right to fish for all species available      rights within the framework of the CWA
                                                Employees, p. 1 (December 1, 2014) (reiterating that       in the waters from which, for so many ages, their          leads to the conclusion, as described
                                                ‘‘EPA must ensure that its actions do not conflict         ancestors derived most of their subsistence is the
                                                with tribal treaty rights’’ and stating that ‘‘EPA         single most highly cherished interest and concern          below, that the human health fishing
                                                programs should be implemented to enhance the              of the present members of plaintiff tribes, with rare      uses for waters in Washington include
                                                protection of tribal treaty rights and treaty-covered      exceptions even among tribal members who                   subsistence fishing, as informed by the
                                                resources when we have the discretion to do so’’);         personally do not fish or derive therefrom any             tribes’ legally protected right to
                                                EPA Policy for the Administration of Environmental         substantial amount of their subsistence.’’); id. at 343
                                                Programs on Indian Reservations (November 8,               (‘‘The evidence shows beyond doubt that at treaty          continue to take fish for subsistence
                                                1984) (known as ‘‘EPA 1984 Indian Policy’’).               time the opportunity to take fish for personal             purposes.39
                                                   33 See http://wdfw.wa.gov/hunting/tribal/treaty_        subsistence and religious ceremonies was the single
                                                history.html.                                              matter of utmost concern to all treaty tribes and             39 While EPA’s action is based on harmonizing
                                                   34 See e.g. Treaty with the Yakima art. 3, June 9,      their members.’’); and U.S. v. Washington, No. 13–         the requirements of the CWA with the terms of the
                                                1855, 12 Stat. 951. In United States v. Winans, 198        35474, 2016 U.S. App. LEXIS 11709, at *29 (9th Cir.        treaty-reserved subsistence fishing right, the action
                                                U.S. 371 (1905), the Supreme Court adopted a               June 27, 2016) (‘‘The Indians reasonably understood        also is consistent with federal Indian law principles
                                                ‘‘reservation of rights’’ approach in interpreting the     Governor Stevens to promise not only that they             addressing subsidiary treaty rights. A written legal
                                                Stevens Treaty with the Yakima Nation: ‘‘the treaty        would have access to their usual and accustomed            opinion from the Solicitor of the U.S. Department
                                                was not a grant of rights to the Indians, but a grant      fishing places, but also that there would be fish          of Interior (DOI) to EPA analyzed whether tribal
                                                of rights from them—a reservation of those not             sufficient to sustain them.’’).                            reserved fishing rights include subsidiary rights to
                                                                                                              37 U.S. v Washington, 384 F. Supp. at 355–358
                                                granted.’’ Id. at 381. In contrast, ‘‘off reservation                                                                 sufficient water quality. Letter from Hilary C.
                                                fishing by other citizens and residents of the state       (internal citations to exhibits omitted).                  Tompkins, Solicitor, DOI, to Avi Garbow, General
                                                is not a right but merely a privilege which may be            38 See e.g., Washington v. Washington State             Counsel, EPA, regarding Maine’s WQS and Tribal
                                                granted, limited or withdrawn by the state as the          Commercial Passenger Fishing Vessel Ass’n, 443             Fishing Rights of Maine Tribes (January 30, 2015).
                                                interests of the state or the exercise of treaty fishing   U.S. 658, 678–679 (1979) (Because the Indians had          Although DOI’s legal opinion primarily involved an
                                                rights may require.’’ U.S. v Washington, 384 F.            always exercised the right to meet their subsistence       analysis of fishing rights of tribes in Maine in
                                                Supp. 312, 332 (W.D. Wash. 1974) aff’d 520 F.2d            and commercial needs by taking fish from treaty            connection with EPA’s February 2, 2015 decision to
                                                676 (9th Cir. 1975), cert. denied 423 U.S. 1086            area waters, they would be unlikely to perceive a          disapprove WQS applied to waters of Indian Lands
                                                (1976).                                                    ‘‘reservation’’ of that right as merely the chance,        in Maine, its discussion of tribal fishing rights and
                                                   35 See Seufert Bros. Co. v. U.S., 249 U.S. 194, 199     shared with millions of other citizens, occasionally       water quality has relevance to tribes with reserved
                                                (1919). In U.S. v Washington, the court stated, citing     to dip their nets into the territorial waters.             fishing rights in Washington. DOI’s legal opinion
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                                                Seufert Bros. Co., ‘‘every fishing location where          Moreover, the phrasing of the clause quite clearly         identified several court decisions, including
                                                members of a tribe customarily fished from time to         avoids placing each individual Indian on an equal          Supreme Court decisions interpreting the reserved
                                                time at and before treaty times, however distant           footing with each individual citizen of the State.’’);     fishing right in the Stevens Treaties, which have
                                                from the then usual habitat of the tribe, and              U.S. v. Washington, 2016 U.S. App. LEXIS 11709             held that fishing rights for tribes encompass
                                                whether or not other tribes then also fished in the        at *28 (Observing that to the Tribes, the Stevens          subsidiary rights that are necessary to render those
                                                same waters, is a usual and accustomed ground or           Treaties’ ‘‘principal purpose was to secure a means        rights meaningful. In Washington v. Wash. State
                                                station at which the treaty tribe reserved, and its        of supporting themselves once the Treaties took            Commercial Passenger Fishing Vessel Ass’n, the
                                                members presently have, the right to take fish.’’ 384      effect,’’ and to that end, ‘‘[s]almon were a central       United States Supreme Court held that tribes with
                                                F. Supp. at 332.                                           concern.’’).                                                                                           Continued




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                                                85424            Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                c. Use(s) of the Water(s) in Question                        subsistence fishing component based                 the particular population to protect is an
                                                   Consistent with EPA’s September 14,                       on, and consistent with, the rights                 important decision to make when
                                                2015 proposed rule for Washington, in                        reserved to the tribes through the                  setting human health criteria.42 EPA
                                                order to effectuate and harmonize                            treaties. As discussed in more detail               recommends that states provide
                                                treaty-reserved fishing rights with the                      below, EPA construes the CWA to                     adequate protection from adverse health
                                                CWA, EPA has determined that such                            require that, when establishing WQS for             effects to the general population, as well
                                                rights must be appropriately considered                      these waters, the tribal members must               as to highly exposed populations, such
                                                when determining which criteria are                          be considered the target general                    as recreational and subsistence fishers,
                                                sufficient to adequately protect                             population for the purposes of setting              two distinct groups with FCRs that may
                                                Washington’s designated uses. Looking                        risk levels to protect the subsistence              be greater than the general population.43
                                                at the treaty-reserved subsistence fishing                   fishing use.                                        In fact, EPA’s 2000 Methodology
                                                right within the CWA water quality                           d. Target General Population for                    recommends considering how to protect
                                                framework, the first step is to examine                      Deriving Criteria Protective of the Use(s)          both susceptible and highly exposed
                                                the use of the water(s) in question. The                                                                         populations when setting criteria:
                                                                                                                Developing criteria to protect the fish
                                                CWA generally assigns to a state the                                                                               EPA recommends that priority be given to
                                                                                                             and shellfish harvesting use, which
                                                responsibility of determining the                                                                                identifying and adequately protecting the
                                                                                                             includes subsistence fishing as informed
                                                designated uses of its waters (subject to                                                                        most highly exposed population. Thus, if the
                                                                                                             by reserved fishing rights, necessarily
                                                certain restrictions at 40 CFR 131.10),40                                                                        State or Tribe determines that a highly
                                                                                                             involves identifying tribal members                 exposed population is at greater risk and
                                                and in Washington the state’s
                                                                                                             with reserved fishing rights as the target          would not be adequately protected by criteria
                                                designated uses include fish and
                                                                                                             population for protection. EPA’s                    based on the general population, and by the
                                                shellfish harvesting.41 As explained
                                                                                                             conclusion to identify tribes as the                national 304(a) criteria in particular, EPA
                                                above, through treaties, tribes reserved
                                                                                                             target population is based on EPA’s                 recommends that the State or Tribe adopt
                                                specific fishing rights in Washington’s
                                                                                                             CWA implementing regulations                        more stringent criteria using alternative
                                                waters, including the right to take fish
                                                                                                             requiring criteria to support the most              exposure assumptions.44
                                                from such waters for their subsistence.
                                                                                                             sensitive use (i.e., subsistence fishing)
                                                In order to effectuate these rights in                                                                           Therefore, consistent with the guidance,
                                                                                                             and EPA’s 2000 Methodology
                                                harmony with the CWA, EPA has                                                                                    EPA identifies the tribal population as
                                                                                                             recommendation that priority be given
                                                interpreted the state’s EPA-approved                                                                             the target population for protection and
                                                                                                             to identifying and protecting highly
                                                designated fish and shellfish harvesting                                                                         the subsistence fishing use must be the
                                                                                                             exposed populations. Further, in order
                                                use to include or encompass a                                                                                    focus of the risk assessment supporting
                                                                                                             to derive water quality criteria sufficient
                                                                                                             under the CWA to ensure that the tribes’            water quality criteria to adequately
                                                reserved fishing rights are entitled to something                                                                protect that use. Deriving criteria
                                                more tangible than ‘‘merely the chance . . .                 treaty-reserved right to take fish for
                                                occasionally to dip their nets into the territorial          subsistence purposes is not                         protective of the tribal target population
                                                seas.’’ 443 U.S. 658, 679 (1979). Consistent with this       substantially affected or impaired, it is           necessarily involves determining the
                                                reasoning, courts have held that treaty-reserved             reasonable and appropriate to identify              appropriate inputs for calculating
                                                fishing rights entail the right to access fishing                                                                protective criteria for tribal subsistence
                                                grounds and the right to water quantity sufficient           tribes as the target general population
                                                to support fish habitat. See e.g., United States v.          for protection, rather than a                       fishers, such as the FCR and cancer risk
                                                Winans, 198 U.S. 371, 384 (1905) (tribe must be              subpopulation, and apply the 2000                   level.
                                                allowed to cross private property to access                  Methodology’s recommendations on
                                                traditional fishing ground); Seufert Bros. Co. v.
                                                                                                             exposure for the general population to                 EPA’s approach in the 2000
                                                United States, 249 U.S. 194 (1919) (tribe entitled to                                                            Methodology, and its approach used for
                                                cross over and temporarily use any sites which they          the tribal target population.
                                                were accustomed to using at treaty time, including              Per EPA’s regulations at 40 CFR                  deriving national 304(a) recommended
                                                sites outside their ceded territories); United States        131.11(a)(1), water quality criteria must           criteria, is for human health water
                                                v. Adair, 723 F .2d 1394, 1409–10 (9th Cir. 1983)            contain sufficient parameters or                    quality criteria to provide a high level
                                                (holding that the tribe’s fishing right implicitly                                                               of protection for the general population
                                                reserved sufficient waters to ‘‘secure to the Tribe a        constituents to protect the designated
                                                continuation of its traditional . . . fishing lifestyle’’;   use, and for waters with multiple uses,             (for example, FCRs designed to
                                                Colville Confederated Tribes v. Walton, 647 F.2d 42,         the criteria must support the most                  represent ‘‘the general population of fish
                                                47–48 (9th Cir. 1981) (implying reservation of water         sensitive use. In the case of                       consumers,’’ or a cancer risk level that
                                                to preserve tribe’s replacement fishing grounds).                                                                ‘‘reflects an appropriate risk for the
                                                Consistent with these precedents, in June 2016 the           Washington’s human health-related
                                                U.S. Court of Appeals for the Ninth Circuit affirmed         uses, the most sensitive use is fish and            general population’’), while recognizing
                                                the district court’s finding that barrier culverts           shellfish harvesting, which, as                     that more highly exposed
                                                constructed by the State of Washington obstructing           explained above, EPA has interpreted to             ‘‘subpopulations’’ may face greater
                                                fish passage were in violation of tribal fishing rights                                                          levels of risk.45 The 2000 Methodology
                                                set forth in the Stevens Treaties, noting that ‘‘the         include or encompass a subsistence
                                                Tribes’ right of access to their usual and                   fishing component based on, and                     does not, however, speak to or envision
                                                accustomed fishing places would be worthless                 consistent with, the rights reserved to             the unique situation of setting WQS that
                                                without harvestable fish.’’ United States v.                 the tribes through the treaties.                    cover areas where tribes have treaty-
                                                Washington, 2016 U.S. App. LEXIS 11709 at *31.                                                                   reserved rights to practice subsistence
                                                The court also acknowledged that the fishing clause          Developing water quality criteria to
                                                of the Stevens Treaties could give rise to other             protect the subsistence fishing
                                                                                                                                                                   42 EPA’s   2000 Methodology, 2–1.
                                                environmental obligations, but that those would              component of the fish or shellfish
                                                need to be addressed on a case-by-case basis                                                                       43 Id. at 2–2.
                                                                                                             harvesting use necessarily involves
                                                depending on the precise nature of the action. Id.                                                                 44 EPA’s 2000 Methodology, 2–1—2. See also
                                                at *18–19. Consistent with this body of case law,            identifying the population exercising
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                                                                                                                                                                 EPA’s 2000 Methodology, 4–17 (‘‘When choosing
                                                DOI’s legal opinion concludes that ‘‘fundamental,            that use.                                           exposure factor values to include in the derivation
                                                longstanding tenets of federal Indian law support               EPA’s decision to identify tribes as             of a criterion for a given pollutant, EPA
                                                the interpretation of tribal fishing rights to include       the target population is further                    recommends considering values that are relevant to
                                                the right to sufficient water quality to effectuate the                                                          population(s) that is (are) most susceptible to that
                                                fishing right.’’ DOI Letter at 10.
                                                                                                             supported by EPA guidance for
                                                                                                                                                                 pollutant. In addition, highly exposed populations
                                                   40 33 U.S.C. 1251(a)(2), 1313(c)(2)(A).                   developing water quality criteria to                should be considered when setting criteria.’’).
                                                   41 See WAC 173–201A–600 and WAC 173–201A–                 protect human health. As explained in                 45 See EPA’s 2000 Methodology, 2–6—7, 4–24—

                                                610.                                                         EPA’s 2000 Methodology, the choice of               25.



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                                                                 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                            85425

                                                fishing.46 Nevertheless, it is possible to               level of incremental risk no greater than                use a FCR that is suppressed would not
                                                apply the general principles outlined in                 one in ten thousand (1 × 10¥4).47                        result in criteria that actually protect a
                                                the 2000 Methodology to this situation,                  However, where treaty-reserved tribal                    fishing use because it would merely
                                                as informed by the treaties.                             fishing rights apply to particular waters,               reinforce the existing suppressed use, or
                                                   In light of the presence of the treaty-               it would be unreasonable to expose the                   worse, set in motion a ‘‘downward
                                                reserved fishing rights in Washington,                   communities exercising those rights to                   spiral’’ 51 of further reduction/
                                                interpreted by the U.S. Supreme Court                    levels of risk above what would be                       suppression of fish consumption due to
                                                to encompass, among other things,                        reasonable for the general population of                 concerns about the safety of available
                                                subsistence fishing, and EPA’s                           the state. See section III.C.b for more                  fish or depleted fisheries. The CWA is
                                                interpretation of Washington’s fish and                  information on cancer risk level.                        meant not merely to maintain the status
                                                shellfish harvesting use to include                                                                               quo, but to restore and maintain the
                                                subsistence fishing, it is reasonable and                e. Water Quality Criteria Sufficient To
                                                                                                                                                                  chemical, physical, and biological
                                                appropriate to require that tribes with                  Protect the Use(s)
                                                                                                                                                                  integrity of the Nation’s waters.
                                                such rights be considered as the target                     The data used to determine the FCR                    Therefore, deriving criteria using an
                                                general population for deriving criteria                 are critical to deriving criteria that will              unsuppressed FCR furthers the
                                                protective of the use rather than a                      protect the subsistence fishing portion                  restoration goals of the CWA and
                                                sensitive subpopulation within the                       of the fish and shellfish harvesting                     ensures protection of human health-
                                                overall population of Washington.                        designated use. EPA provides a                           related designated uses (as pollutant
                                                Treating tribes as the target general                    recommended national default FCR for                     levels decrease, fish habitats are
                                                population will help derive water                        the general population but strongly                      restored, and fish availability increases
                                                quality criteria sufficient under the                    recommends the use of local or regional                  over time).
                                                CWA to ensure that the tribes’ treaty-                   data, where available, over default                         CWA section 303(c)(2)(A) requires
                                                reserved right to take fish for                          values.48 Further, as EPA explained in                   that water quality criteria be ‘‘based
                                                subsistence purposes is not                              its January 2013 Human Health                            upon’’ applicable designated uses, and
                                                substantially affected or impaired.                      Ambient Water Quality Criteria and                       that such uses and criteria ‘‘shall be
                                                Therefore, the 2000 Methodology’s                        Fish Consumption Rates: Frequently                       such as to protect the public health or
                                                recommendations on exposure for the                      Asked Questions, it is important to                      welfare, enhance the quality of water
                                                target general population can be applied                 avoid selecting a FCR that reflects                      and serve the purposes of this [Act].’’
                                                accordingly. EPA’s conclusion to treat                   consumption that is suppressed due to                    The ‘‘purposes of this [Act]’’ are in
                                                tribes as the target general population,                 concerns about the safety of available                   section 101, and include, among other
                                                as opposed to a subpopulation, is                        fish. Under certain circumstances, it                    things, ‘‘to restore and maintain the
                                                further supported by relevant case law                   may also be relevant to look at the                      chemical, physical, and biological
                                                interpreting the treaty-reserved fishing                 availability of fish when considering                    integrity of the Nation’s waters’’ and
                                                rights applicable in Washington;                         suppression effects on current FCRs.49                   ‘‘water quality which provides for the
                                                specifically the phrase ‘‘in common                      EPA maintains that it is important, as a                 protection and propagation of fish,
                                                with all citizens of the territory.’’                    CWA goal, to avoid the suppression                       shellfish, and wildlife and provides for
                                                   Treating tribes as the target                         effect that may occur when criteria are                  recreation in and on the water.’’ EPA’s
                                                population instead of a sensitive                        derived using a FCR for a given target                   implementing water quality regulations
                                                subpopulation also impacts another                       population that reflects an artificially                 at 40 CFR 131.11 require water quality
                                                important input parameter used to                        diminished level of fish consumption                     criteria to be based on sound scientific
                                                derive human health criteria, the cancer                 from an appropriate baseline level of                    rationale and sufficient to protect the
                                                risk level. For carcinogenic pollutants,                 consumption for that population.50 To                    designated use, regardless of whether
                                                EPA’s 2000 Methodology recommends                                                                                 that use is currently being met. A
                                                that states protect the general
                                                                                                           47 2000  Methodology, 2–6.                             subsistence fishing designated use, by
                                                                                                           48 EPA’s   2000 Methodology, 4–24—4–25 (‘‘EPA’s
                                                population to a level of incremental                                                                              definition, represents a level of fish
                                                                                                         first preference is that States and authorized Tribes
                                                cancer risk no greater than one in one                   use the results from fish intake surveys of local
                                                                                                                                                                  consumption that is adequate to provide
                                                hundred thousand to one in one million                   watersheds within the State or Tribal jurisdiction to    subsistence, regardless of whether such
                                                (1 × 10¥5 to 10¥6). For over 20 years,                   establish fish intake rates that are representative of   consumption is occurring today. It is
                                                                                                         the defined populations being addressed for the          entirely consistent with the CWA and
                                                Washington has used 10¥6 as the level                    particular waterbody.’’)
                                                of risk that must be used to establish                      49 As noted by the National Environmental Justice
                                                                                                                                                                  regulations for EPA to determine that to
                                                human health criteria for carcinogenic                   Advisory Council in the 2002 publication Fish            protect the designated use, it is
                                                pollutants. EPA’s 2000 Methodology                       Consumption and Environmental Justice, ‘‘a               necessary and appropriate to derive the
                                                                                                         suppression effect may arise when fish upon which        human health criteria using a fish
                                                indicates that if there are highly                       humans rely are no longer available in historical
                                                exposed groups or subpopulations                         quantities (and kinds), such that humans are unable
                                                                                                                                                                  consumption rate that reflects a
                                                within that target general population,                   to catch and consume as much fish as they had or         subsistence level of consumption that is
                                                such as subsistence consumers, WQS                       would. Such depleted fisheries may result from a         not artificially suppressed as a result of
                                                                                                         variety of affronts, including an aquatic                concerns about pollution or fish
                                                should protect those consumers to a                      environment that is contaminated, altered (due,
                                                                                                         among other things, to the presence of dams),
                                                                                                                                                                  contamination where such data are
                                                   46 In response to comments on EPA’s 1998 draft        overdrawn, and/or overfished. Were the fish not          available.
                                                Human Health Methodology revisions, the Agency           depleted, these people would consume fish at more           Any fish consumption rate used in
                                                responded: ‘‘As stated in the 1998 draft                 robust baseline levels. . . . In the Pacific             setting criteria to protect a subsistence
                                                Methodology revisions, ‘risk levels and criteria         Northwest, for example, compromised aquatic              fishing use must allow for the
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                                                need to be protective of tribal rights under federal     ecosystems mean that fish are no longer available
                                                law (e.g., fishing, hunting, or gathering rights) that   for tribal members to take, as they are entitled to      consumption of fish from local waters at
                                                are related to water quality.’ We believe the best       do in exercise of their treaty rights.’’). National      levels that could sustain and be
                                                way to ensure that Tribal treaty and other rights        Environmental Justice Advisory Council, Fish             protective of members of the target
                                                under Federal law are met, consistent with the           Consumption and Environmental Justice, p.44, 46
                                                                                                         (2002) available at https://www.epa.gov/sites/
                                                                                                                                                                  population practicing a subsistence
                                                Federal trust responsibility, is to address these
                                                issues at the time EPA reviews water quality             production/files/2015–02/documents/fish-                 lifestyle. Water quality criteria derived
                                                standards submissions.’’ (See 65 FR 66444, 66457         consump-report_1102.pdf.
                                                November 3, 2000).                                          50 See id. at 43.                                      51 See   id. at 47.



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                                                85426            Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                using a FCR below a level that would be                 areas when administering the WQS,                        for all tribes in Washington. Consistent
                                                adequate to sustain members of the                      NPDES permitting, and other programs.                    with the principles outlined above, EPA
                                                target population exercising a                          Therefore, EPA applies these final                       considered the available, scientifically
                                                subsistence use, such as tribal members                 criteria to all waters under Washington’s                sound fish consumption data for
                                                who have a history of subsistence                       jurisdiction.                                            Washington tribes and consulted with
                                                fishing in Washington, would not be                        Many commenters supported EPA’s                       tribal governments to select a FCR for
                                                protective of that use. In this context,                decisions to derive criteria protective of               this final rulemaking.
                                                use of an unsuppressed rate, where data                 the tribal population exercising their                      The Washington tribes have generally
                                                to determine that rate are available,                   treaty-reserved fishing rights in                        agreed that 175 g/day is acceptable for
                                                would ensure that the resulting criteria                Washington as the target general                         deriving protective criteria at this time,
                                                are protective of the subsistence use.                  population, and to apply the resulting                   when accompanied by other protective
                                                   The importance of relying on an                      criteria to all waters under Washington’s                input parameters to calculate the
                                                unsuppressed FCR, where data are                        jurisdiction. Many other commenters                      criteria. However, EPA recognizes that
                                                available, is especially evident where                  did not support these decisions, and                     some tribes have raised concerns as to
                                                the subsistence use is based in whole or                argued that EPA did not have a                           whether a FCR of 175 g/day reasonably
                                                in part on tribal treaty and other                      scientific or legal basis to interpret                   reflects current unsuppressed
                                                reserved subsistence fishing rights. This               Washington’s designated uses to                          consumption rates of tribes within the
                                                is because if human health criteria are                 encompass subsistence fishing and to                     State of Washington, based on the best
                                                set at a level that assumes only                        treat the tribal population with treaty-                 currently available information. A FCR
                                                suppressed fish consumption, the                        reserved fishing rights as the target                    of 175 g/day approximates the 95th
                                                waters will only be protected to support                general population for protection under                  percentile consumption rate of surveyed
                                                that level of suppressed fish                           such use. For additional responses to                    tribal members from the CRITFC
                                                consumption and thus never fully                        these comments, see EPA’s Response to                    study 54 and includes anadromous fish,
                                                support—and potentially even may                        Comment document in the docket for                       which is reasonable given that these
                                                directly impair—the tribes’ legal right to              this rule.                                               marine species reside in Washington’s
                                                take fish for subsistence purposes.                                                                              nearshore (i.e., within three miles of the
                                                                                                        C. Washington-Specific Human Health
                                                Accordingly, where adequate data are                                                                             coast) waters, especially Puget Sound,
                                                                                                        Criteria Inputs
                                                available to clearly demonstrate what                                                                            and accumulate pollutants discharged to
                                                the current unsuppressed FCR is for the                 a. Fish Consumption Rate                                 these waters during a significant portion
                                                relevant target population, the selected                   In Washington there are 24 tribes with                of their lives. The CRITFC survey also
                                                FCR must reflect that value. In the                     treaty-reserved fishing rights, rights that              includes four tribes (three of which have
                                                absence of such data, states, tribes, and               encompass the right to fish for                          treaty-reserved rights in Washington,
                                                EPA could consider upper percentile                     subsistence purposes, and several local                  the most of any one contemporary FCR
                                                FCRs of local contemporary fish                         and regional FCR surveys and heritage                    survey in Washington) along the
                                                consumption surveys (such as the 95th                   tribal consumption reports with widely                   Columbia River in Washington, Idaho,
                                                or 99th percentile), heritage FCR data                  varying estimates of tribal FCRs in                      and Oregon. Given this, and also
                                                for the target population, and/or FCRs                  Washington (for tables of relevant FCRs,                 considering the variability in heritage
                                                that provide for a subsistence fishing                  see EPA’s Response to Comment                            and contemporary FCRs and the
                                                lifestyle. Consultation with tribes is                  document in the docket for this rule).                   uncertainty regarding suppression
                                                important to ensure that all data and                   Available heritage FCRs range from 401                   effects on current FCRs, the CRITFC
                                                information relevant to this issue are                  to 995 g/day, and contemporary survey                    survey provides scientifically sound
                                                considered.                                             FCRs range from 63 to 214 g/day (mean                    estimates of fish consumption for the
                                                   Although treaties do not cover all
                                                                                                        FCRs) and from 113 to 489 g/day (90th                    purpose of deriving a Washington
                                                waters in Washington, they cover the
                                                                                                        percentile FCRs). The discrepancy                        statewide FCR for the tribal target
                                                vast majority of the state’s waters.
                                                                                                        between contemporary and heritage                        general population.
                                                Additionally, where treaty and non-
                                                                                                        FCRs suggests that current FCRs for                         Additionally, Oregon, much of which
                                                treaty reserved rights apply on waters
                                                                                                        certain tribal consumers in Washington                   is downstream from Washington (or
                                                downstream of waters without reserved
                                                                                                        may be suppressed.52 53 It is currently                  cross-stream in the Columbia River
                                                fishing rights, upstream WQS must
                                                                                                        unclear how a contemporary fish                          where it forms the border between the
                                                provide for the attainment and
                                                                                                        consumption survey might                                 two states), used a FCR of 175 g/day to
                                                maintenance of downstream WQS in
                                                                                                        quantitatively account for suppression,                  derive statewide human health criteria,
                                                accordance with EPA’s regulations at 40
                                                CFR 131.10(b). Based on a GIS analysis                  resulting in estimates of current FCRs                   which EPA approved in 2011. Use of
                                                included in the docket for this final                   that are unsuppressed to the maximum                     this FCR to derive Washington’s criteria
                                                rulemaking, EPA concluded that greater                  degree practicable. There is no local                    will thus help ensure the attainment
                                                than 90 percent of waters in Washington                 survey of contemporary fish                              and maintenance of downstream WQS
                                                are covered by treaty rights and/or are                 consumption in Washington adjusted                       in Oregon.
                                                upstream of waters with such rights or                  specifically to account for suppression,                    Many commenters supported EPA’s
                                                waters in Oregon (see section III.C.a).                 and no survey is a clear representation                  selected FCR, as well as the Agency’s
                                                For any remaining waters in                             of current unsuppressed consumption                      position that it is important to consider
                                                Washington, where reserved rights do                                                                             suppression effects on the FCR in
                                                not apply and that are not upstream of
                                                                                                          52 The number of fish advisories and closures due      general, and necessary and appropriate
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                                                                                                        to contamination also suggest that contemporary          to do so where subsistence fishing is a
                                                waters with such rights or waters in                    FCRs may be suppressed due to concerns about
                                                Oregon, it would be administratively                    pollution. See Washington Department of Health,
                                                                                                                                                                 reserved right and encompassed by the
                                                burdensome to develop separate criteria                 Fish Consumption Advisories, available at http://        designated use of the waters. Some
                                                to apply to such a small subset of                      www.doh.wa.gov/CommunityandEnvironment/
                                                                                                        Food/Fish/Advisories.                                      54 Fish Consumption Survey of the Umatilla, Nez
                                                waters, and would be difficult to                         53 Heritage rates refer to the rates of fish intake    Perce, Yakama, and Warm Springs Tribes of the
                                                implement separate criteria with a                      consistent with traditional tribal practices, prior to   Columbia River Basin (Columbia River Inter-Tribal
                                                patchwork of protection among these                     contact with European settlers.                          Fish Commission (CRITFC), 1994).



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                                                                 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                              85427

                                                commenters expressed concern that 175                   population.55 In this action, as                      concern that EPA was suggesting that
                                                g/day was not high enough to reflect                    described above, tribes with treaty-                  Washington’s upstream criteria must be
                                                current or historical consumption rates                 reserved rights in Washington are the                 identical to Oregon’s downstream
                                                of all tribes in Washington. Many other                 target general population for the                     criteria and in doing so, acting
                                                commenters expressed the opposite                       purpose of deriving revised criteria to               inconsistently with its 2014 Frequently
                                                concern, that 175 g/day was                             protect the subsistence fishing uses of               Asked Questions document on
                                                unreasonably high in order to protect                   Washington’s waters. Because those                    downstream protection.56 For detailed
                                                Washington residents, and argued that                   tribes are the general population in this             responses to these comments, see EPA’s
                                                treaty-reserved rights do not confer the                case, EPA’s selection of a 10¥6 cancer                Response to Comment document in the
                                                right to eat fish at unsuppressed levels.               risk level for the tribal target general              docket for this rule.
                                                Some of those commenters also argued                    population is consistent with current
                                                                                                                                                              c. Relative Source Contribution
                                                that the CWA does not mention                           EPA guidance, specifically the 2000
                                                suppression. For detailed responses to                  Methodology.                                             EPA recommends using a RSC for
                                                these comments, see EPA’s Response to                      In addition, use of a cancer risk rate             non-carcinogens and nonlinear
                                                Comment document in the docket for                      of 10¥6 ensures that the resulting                    carcinogens to account for sources of
                                                this rule.                                              human health criteria for carcinogens                 exposure other than drinking water and
                                                                                                        protect the subsistence fishing                       consumption of inland and nearshore
                                                b. Cancer Risk Level                                    component of the designated use. Due to               fish and shellfish (see section II.C.d). In
                                                                                                        uncertainty regarding suppression                     2015, after evaluating information on
                                                   EPA derives final human health                       effects (see sections II.C, III.B, and                chemical uses, properties, occurrences,
                                                criteria for carcinogens in Washington                  III.C.a, and EPA’s Response to Comment                releases to the environment and
                                                using a cancer risk level of one in one                 document in the docket for this rule),                regulatory restrictions, EPA developed
                                                million (10¥6), based on Washington’s                   using a cancer risk level of 10¥6 along               chemical-specific RSCs for non-
                                                longstanding use of that cancer risk                    with a FCR of 175 g/day ensures that                  carcinogens and nonlinear carcinogens
                                                level, EPA guidance, tribal reserved                    tribal members with treaty-reserved                   ranging from 0.2 (20 percent) to 0.8 (80
                                                fishing rights, and downstream                          fishing rights will be protected at an                percent) following the Exposure
                                                protection requirements.                                acceptable risk level for the target                  Decision Tree approach described in
                                                   To derive final human health criteria                general population. Throughout tribal                 EPA’s 2000 Methodology.57 58 EPA
                                                for each state in the NTR, EPA selected                 consultation, the tribes generally                    proposed to use these same RSCs to
                                                a cancer risk level based on each state’s               supported 175 g/day as an acceptable                  derive human health criteria for
                                                policy or practice regarding what risk                  FCR for purposes of revising                          Washington, and where EPA did not
                                                level should be used when regulating                    Washington’s human health criteria at                 update the nationally recommended
                                                carcinogens in surface waters. In its                   this time, when accompanied by other                  criteria for certain pollutants in 2015,
                                                official comments on EPA’s proposed                     protective input parameters (e.g., a                  EPA proposed to use a RSC of 0.2 to
                                                NTR in 1992, Washington asked EPA to                    cancer risk level of 10¥6), to account for            derive human health criteria for those
                                                promulgate human health criteria using                  the uncertainty around an appropriate                 pollutants in Washington to ensure
                                                a cancer risk level of 10¥6, stating, ‘‘The             FCR value reflective of tribal                        protectiveness.
                                                State of Washington supports adoption                   subsistence fishing.                                     Several commenters supported EPA’s
                                                of a risk level of one in one million for                  Finally, as discussed in section III.C.a,          use of RSCs to account for other sources
                                                carcinogens. If EPA decides to                          many of Washington’s rivers are in the                of pollutant exposure. Several others
                                                promulgate a risk level below one in one                Columbia River Basin, upstream of                     disagreed, arguing that water quality
                                                million, the rule should specifically                   Oregon’s portion of the Columbia River.               criteria under the CWA cannot control
                                                address the issue of multiple                           Oregon’s criteria are based on a FCR of               or consider sources of exposure other
                                                contaminants so as to better control                    175 g/day and a cancer risk level of                  than from drinking water and eating fish
                                                overall site risks.’’ (57 FR 60848,                     10¥6. EPA’s decision to derive human                  and shellfish, so human health criteria
                                                December 22, 1992). Accordingly, in the                 health criteria for Washington using a                should not account for these sources.
                                                NTR, EPA used a cancer risk level of                    cancer risk level of 10¥6 along with a                Many of the commenters, in addition to
                                                10¥6 (one in one million) to derive                     FCR of 175 g/day helps ensure that                    criticizing the concept of RSCs as
                                                human health criteria for Washington.                   Washington’s criteria will ensure the                 overly-conservative, argued that EPA
                                                Subsequently, Washington adopted and                    attainment and maintenance of Oregon’s                was double-counting exposure to
                                                EPA approved a provision in the state’s                 downstream WQS as required by 40                      anadromous fish (which EPA considers
                                                WQS that reads: ‘‘Risk-based criteria for               CFR 131.10(b).                                        marine in the national dataset) by both
                                                carcinogenic substances shall be                           Many commenters supported EPA’s                    including them in the FCR and using
                                                selected such that the upper-bound                      selection of a 10¥6 cancer risk level, and            the pollutant-specific RSCs that EPA
                                                                                                        EPA’s rationale for doing so. Many other              pairs with an inland and nearshore-only
                                                excess cancer risk is less than or equal
                                                to one in a million’’ (WAC 173–201A–                    commenters disagreed and argued that
                                                240(6)). In Washington’s August 1, 2016                 deriving human health criteria for                      56 https://nepis.epa.gov/Exe/ZyPDF.cgi/

                                                                                                        Washington using a 10¥5 cancer risk                   P100LIJF.PDF?Dockey=P100LIJF.PDF.
                                                submittal, the cancer risk level is                                                                             57 USEPA. 2000. Methodology for Deriving

                                                identified in the new text and                          level is appropriate and consistent with              Ambient Water Quality Criteria for the Protection
                                                reformatted toxics criteria table at WAC                EPA guidance and past practice. Many                  of Human Health. U.S. Environmental Protection
                                                173–201A–240.                                           of these commenters stated that tribal                Agency, Office of Water, Washington, DC EPA–822–
                                                                                                        treaties did not confer rights to a                   B–00–004. https://www.epa.gov/wqc/human-
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                                                   Subsequent to promulgating the NTR,                                                                        health-water-quality-criteria.
                                                                                                        particular level of risk. Additionally,                 58 Final Updated Ambient Water Quality Criteria
                                                EPA issued its 2000 Methodology,                        some commenters supported EPA’s                       for the Protection of Human Health, (80 FR 36986,
                                                which states that when promulgating                     consideration of downstream WQS in                    June 29, 2015). See also: USEPA. 2015. Final 2015
                                                water quality criteria for states and                   Oregon when establishing the criteria                 Updated National Recommended Human Health
                                                tribes, EPA intends to use the 10¥6                                                                           Criteria. U.S. Environmental Protection Agency,
                                                                                                        upstream, while others expressed                      Office of Water, Washington, DC https://
                                                cancer risk level, which reflects an                                                                          www.epa.gov/wqc/human-health-water-quality-
                                                appropriate risk for the general                          55 EPA’s   2000 Methodology, pages 2–6.             criteria.



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                                                85428            Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                FCR in its 304(a) national recommended                  fish consumption in the RSC. This                     d. Body Weight
                                                human health criteria. Commenters                       approach assumes that the pollutant                     EPA calculates final human health
                                                argued that this is inconsistent with                   concentrations in anadromous fish are                 criteria for Washington using a body
                                                EPA’s guidance, which recommends                        the same as the pollutant concentrations              weight of 80 kg, which represents the
                                                that states adjust the RSC to reflect a                 in inland and nearshore fish, which is                average weight of a U.S. adult and is
                                                greater proportion of the RfD being                     the same assumption inherent in                       consistent with EPA’s 2015 updated
                                                attributed to water, fish and shellfish                 including multiple fish categories in the             national default body weight (see
                                                intake in instances where the FCR                       FCR for criteria calculation. This                    section II.C.c).61 Local tribal survey data
                                                includes freshwater, estuarine and all                  approach further assumes that the ratio               relevant to Washington are also
                                                marine fish consumption.59 For detailed                 of all fish to inland and nearshore fish              consistent with EPA’s national adult
                                                responses to the comments, see EPA’s                    from NHANES data approximates the                     body weight of 80 kg.62 Most
                                                Response to Comment document in the                     ratio of inland, nearshore, and                       commenters were silent on EPA’s
                                                docket for this rule.                                                                                         proposal to use a body weight of 80 kg
                                                   Additionally, after further evaluation               anadromous fish to just inland and
                                                                                                        nearshore fish from CRITFC data. At the               to calculate human health criteria for
                                                of the proposed revised human health                                                                          Washington. A few commenters were
                                                criteria for antimony, EPA determined                   90th percentile rate of consumption, the
                                                                                                        national adult consumption rate from                  concerned that 80 kg would not ensure
                                                that the existing 304(a) national                                                                             adequate protection of women and
                                                recommended criteria for antimony (last                 NHANES data for all fish is 53 g/day
                                                                                                        and 22 g/day for inland and nearshore-                children, and may not be representative
                                                updated in 2002) use a pollutant-                                                                             of all residents in Washington based on
                                                specific RSC of 0.4. EPA intended to                    only fish, or a ratio of 2.4. Applying this
                                                                                                        to a RSC of 0.2 yields 0.48, or 0.5                   limited local or regional data on body
                                                apply a 0.2 RSC as a protective                                                                               weight specific to Washington residents.
                                                approach only where pollutant-specific                  rounding to a single decimal place.
                                                                                                                                                              EPA understands these concerns, but
                                                RSCs were not already developed,                        Because the selected FCR includes some
                                                                                                                                                              decided that the survey on which EPA’s
                                                which is not the case for antimony.60                   but not all marine species, EPA decided               national default of 80 kg is based
                                                   While the selected FCR of 175 g/day                  to use this approach to adjust the RSC                provides the most comprehensive
                                                does not include all marine fish (e.g., it              values. However, EPA only adjusted                    dataset to establish a body weight value
                                                does not include consumption of                         RSC values to 0.5 for criteria                        for deriving statewide human health
                                                species such as swordfish, tuna, etc.),                 calculations previously using a RSC                   criteria for Washington, and is
                                                EPA acknowledges that the criteria as                   between 0.2 and 0.5.                                  consistent with the local tribal survey
                                                proposed may have double-counted
                                                                                                           There are important considerations in              data mentioned above. The data cited by
                                                potential exposure to some pollutants in
                                                                                                        assigning a RSC, such as the total                    commenters do not provide sufficient
                                                certain marine fish that are anadromous
                                                                                                        number of potential exposure routes                   evidence to come up with an alternative
                                                (e.g., salmon). Therefore, EPA reviewed
                                                                                                        from sources other than fish                          statewide body weight input parameter
                                                the RSCs in the proposed rule in light
                                                                                                        consumption, which compels caution in                 since the studies cited are limited in
                                                of EPA’s guidance, which includes both
                                                                                                        using this approach in all cases. As                  scope and pertain to specific
                                                the Exposure Decision Tree and
                                                                                                        such, EPA decided to retain RSC values                subpopulations. For detailed responses
                                                associated discussion in EPA’s 2000
                                                Methodology, as well as EPA’s                           of 0.5 and above, recognizing the                     to the comments, see EPA’s Response to
                                                recommendation to adjust the RSC                        compelling need to account for the other              Comment document in the docket for
                                                when the FCR includes freshwater,                       potential exposure sources, including                 this rule.
                                                estuarine, and all marine fish                          marine fish not accounted for in the                  e. Drinking Water Intake
                                                consumption. Arguably, EPA’s guidance                   FCR of 175 g/day, consistent with the                    EPA calculates final human health
                                                does not consider this exact scenario                   logic and procedures used in                          criteria for Washington using a drinking
                                                where the selected FCR includes some,                   establishing the national 304(a) criteria             water intake rate of 2.4 L/day, consistent
                                                but not all, species that EPA classifies                recommendations. The Exposure                         with EPA’s 2015 updated national
                                                as marine in the national NHANES                        Decision Tree in EPA’s 2000                           default drinking water intake rate (see
                                                dataset (and excludes some species that                 Methodology only recommends using a                   section II.C.c).63 Most commenters were
                                                EPA classifies as nearshore in the                      RSC above 0.5 when there are no
                                                national NHANES dataset, i.e.,                          significant known or potential uses/                     61 Final Updated Ambient Water Quality Criteria
                                                shellfish).                                             sources other than the source of concern              for the Protection of Human Health, (80 FR 36986,
                                                   One way to adjust the RSC values to                  (Box 7, Figure 4–1 in EPA’s 2000                      June 29, 2015). See also: USEPA. 2015. Final 2015
                                                account for inclusion of marine fish in                                                                       Updated National Recommended Human Health
                                                                                                        Methodology) or there are sufficient                  Criteria. U.S. Environmental Protection Agency,
                                                the FCR is to examine the ratio of the
                                                                                                        data available on each source to                      Office of Water, Washington, DC https://
                                                national data characterizing all fish                                                                         www.epa.gov/wqc/human-health-water-quality-
                                                                                                        characterize the exposure to those
                                                consumption rates versus inland and                                                                           criteria.
                                                nearshore-only fish consumption rates                   sources (Box 8C, Figure 4–1). Neither of                 62 USEPA Region 10. August 2007. Framework for

                                                derived from the NHANES dataset, and                    these conditions are met for most of the              Selecting and Using Tribal Fish and Shellfish
                                                apply this ratio to the proportion of the               pollutants in the final rule for                      Consumption Rates for Risk-Based Decision Making
                                                                                                        Washington. EPA is not adjusting the                  at CERCLA and RCRA Cleanup Sites in Puget
                                                RfD reserved for inland and nearshore                                                                         Sound and the Strait of Georgia. Appendix B.
                                                                                                        RSCs for pollutants that already have                 http://yosemite.epa.gov/r10/CLEANUP.NSF/
                                                  59 USEPA. January 2013. Human Health Ambient          national recommended RSCs greater                     7780249be8f251538825650f0070bd8b/
                                                Water Quality Criteria and Fish Consumption Rates:      than or equal to 0.5 (2–                              e12918970debc8e488256da6005c428e/$FILE/
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                                                Frequently Asked Questions. https://www.epa.gov/        Chloronaphthalene (0.8), Endrin (0.8),                Tribal%20Shellfish%20Framework.pdf.
                                                wqc/human-health-ambient-water-quality-criteria-                                                                 63 Final Updated Ambient Water Quality Criteria
                                                and-fish-consumption-rates-frequently-asked.            gamma-BHC/Lindane (0.5), and                          for the Protection of Human Health, (80 FR 36986,
                                                  60 http://nepis.epa.gov/Exe/                          methylmercury (2.7 × 10¥5 subtracted                  June 29, 2015). See also: USEPA. 2015. Final 2015
                                                ZyPDF.cgi?Dockey=20003IEI.txt See also: National        from the RfD, which equates to a RSC                  Updated National Recommended Human Health
                                                Primary Drinking Water Regulations-Synthetic                                                                  Criteria. U.S. Environmental Protection Agency,
                                                Organic Chemicals and Inorganic Chemicals;
                                                                                                        of approximately 0.73). See Table 1,                  Office of Water, Washington, DC https://
                                                National Primary Drinking Water Regulations             column B2 for a list of EPA’s final RSCs              www.epa.gov/wqc/human-health-water-quality-
                                                Implementation, 57 FR 31776, July 17, 1992.             by pollutant.                                         criteria.



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                                                                 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                               85429

                                                silent on or agreed with EPA’s proposal                 list of EPA’s final toxicity factors by               final bioaccumulation factors by
                                                to use a drinking water intake rate of 2.4              pollutant.                                            pollutant.
                                                L/day to calculate human health criteria                   In general, commenters were                           Many commenters supported EPA’s
                                                for Washington. However, two                            supportive of EPA using the latest and                choice to use the latest and most
                                                commenters stated this input was                        most scientifically defensible toxicity               scientifically defensible BAFs to derive
                                                unnecessary in human health criteria                    values to derive human health criteria                human health criteria for Washington,
                                                derivation. Since at least the 1980s, EPA               for Washington. Some commenters                       and to use BCFs only when BAFs were
                                                has included the drinking water                         expressed concern that where EPA did                  not available for a given pollutant. Other
                                                exposure pathway in the development                     not update its 304(a) national                        commenters asserted that BCFs are no
                                                of human health criteria in order to                    recommended human health criteria for                 less scientifically defensible than BAFs,
                                                protect water bodies with a drinking                    particular pollutants in 2015, the                    and that EPA did not provide sufficient
                                                water designated use. EPA also provides                 toxicity values from the existing 304(a)              information regarding how it developed
                                                the option of using organism-only                       criteria for those pollutants were no                 BAFs in 2015 for commenters to fully
                                                                                                        longer valid. In particular, those                    evaluate EPA’s proposed approach.
                                                human health criteria for water bodies
                                                                                                        commenters expressed concern about                       EPA’s 2000 Methodology
                                                where there is no drinking water use.                                                                         recommends use of BAFs that account
                                                One commenter stated that 2.4 L/day                     the CSFs for arsenic and PCBs, and the
                                                                                                        RfD for methylmercury, and argued that                for uptake of a contaminant from all
                                                was an underestimate, and expressed                                                                           sources by fish and shellfish, rather than
                                                concern that this value is not protective               EPA should not revise Washington’s
                                                                                                        criteria for those pollutants until                   BCFs that only account for uptake from
                                                of tribal members who consume more                                                                            the water column. EPA’s 2015 national
                                                water. EPA determined that it is                        toxicity factors are updated in the
                                                                                                                                                              recommended BAFs are based on peer-
                                                appropriate to use its 2015 final national              future. Unlike the situation with the
                                                                                                                                                              reviewed, publicly available data and
                                                default drinking water intake rate, since               toxicity factors for arsenic, dioxin and
                                                                                                                                                              were developed consistent with EPA’s
                                                it was adjusted pursuant to public                      thallium (see section III.A), there is not
                                                                                                                                                              2000 Methodology and its supporting
                                                comments after EPA issued the draft                     sufficient scientific uncertainty
                                                                                                                                                              documents. EPA provided the basis for
                                                national default rate of 3 L/day in 2014.               surrounding the CSF for PCBs or the
                                                                                                                                                              its 2015 BAFs in individual pollutant-
                                                EPA acknowledges the concerns about                     RfD for methylmercury to warrant
                                                                                                                                                              specific criteria documents. The final
                                                members of the target general                           delaying revision to Washington’s
                                                                                                                                                              human health criteria for Washington
                                                population who may consume larger                       human health criteria for these
                                                                                                                                                              are consistent with EPA’s 2000
                                                amounts of water, but EPA does not                      pollutants. For detailed responses to the             Methodology, which makes clear that
                                                have data (and did not receive any                      comments, see EPA’s Response to                       BAFs are a more scientifically
                                                                                                        Comment document in the docket for                    defensible representation of
                                                during the public comment period) with
                                                                                                        this rule.                                            bioaccumulation than BCFs. For
                                                which to calculate a Washington-
                                                specific drinking water intake rate. For                g. Pollutant-Specific Bioaccumulation                 detailed responses to the comments, see
                                                detailed responses to the comments, see                 Factors                                               EPA’s Response to Comment document
                                                EPA’s Response to Comment document                                                                            in the docket for this rule.
                                                                                                           For the 2015 national 304(a) human
                                                in the docket for this rule.                                                                                  D. Final Human Health Criteria for
                                                                                                        health criteria update, EPA estimated
                                                f. Pollutant-Specific Reference Doses                   chemical-specific BAFs using a                        Washington
                                                and Cancer Slope Factors                                framework for deriving national BAFs                    EPA finalizes 144 human health
                                                                                                        described in EPA’s 2000 Methodology.65                criteria for 74 different pollutants (72
                                                   As part of EPA’s 2015 updates to its                 Because the surveyed population upon                  organism-only criteria and 72 water-
                                                304(a) recommended human health                         which the 175 g/day FCR is based                      plus-organism criteria) to protect the
                                                criteria, EPA conducted a systematic                    consumed almost exclusively trophic                   applicable designated uses of
                                                search of eight peer-reviewed, publicly                 level four fish (i.e., predator fish                  Washington’s waters (see Table 1). The
                                                available sources to obtain the most                    species), EPA uses the trophic level four             water-plus-organism criteria in column
                                                current toxicity values for each                        BAF from the 2015 304(a) human health                 C1 and the methylmercury criterion in
                                                pollutant (RfDs for non-carcinogenic                    criteria updates in conjunction with the              column C2 of Table 1 are the applicable
                                                effects and CSFs for carcinogenic                       175 g/day FCR, in order to derive                     criteria for any waters that include the
                                                effects).64 EPA calculates final human                  protective criteria.66 Where in 2015,                 Domestic Water (domestic water supply)
                                                health criteria for Washington using the                EPA estimated BAFs from laboratory-                   use defined in Washington’s WQS
                                                same toxicity values that EPA used in                   measured BCFs and therefore derived a                 (WAC 173–201A–600). The organism-
                                                its 2015 304(a) criteria updates, to                    single pollutant-specific BAF for all                 only criteria in column C2 of Table 1
                                                ensure that the resulting criteria are                  trophic levels, EPA uses those single                 apply to waters that do not include the
                                                based on a sound scientific rationale.                  BAFs from the 2015 304(a) human                       Domestic Water (domestic water supply)
                                                Where EPA did not update criteria for                   health criteria updates. Where EPA’s                  use and that Washington defines at
                                                certain pollutants in 2015 and those                    existing 304(a) recommended human                     WAC 173–201A–600 and 173–201A–
                                                pollutants are included in this final                   health criteria for certain pollutants still          610 as the following: Fresh waters—
                                                rule, EPA uses the toxicity values that                 incorporate a BCF, and those pollutants               Harvesting (fish harvesting), and
                                                the Agency used the last time it updated                are included in this final rule, EPA uses             Recreational Uses; Marine waters—
                                                its 304(a) criteria for those pollutants as             those BCFs as the best available                      Shellfish Harvesting (shellfish—clam,
                                                the best available scientific information.              scientific information. See Table 1,                  oyster, and mussel—harvesting),
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                                                See Table 1, columns B1 and B3 for a                    columns B4 and B5 for a list of EPA’s                 Harvesting (salmonid and other fish
                                                  64 Final Updated Ambient Water Quality Criteria       www.epa.gov/wqc/human-health-water-quality-           B–00–004. https://www.epa.gov/wqc/human-
                                                for the Protection of Human Health, (80 FR 36986,       criteria.                                             health-water-quality-criteria.
                                                June 29, 2015). See also: USEPA. 2015. Final 2015         65 USEPA. 2000. Methodology for Deriving              66 Fish Consumption Survey of the Umatilla, Nez

                                                Updated National Recommended Human Health               Ambient Water Quality Criteria for the Protection     Perce, Yakama, and Warm Springs Tribes of the
                                                Criteria. U.S. Environmental Protection Agency,         of Human Health. U.S. Environmental Protection        Columbia River Basin (Columbia River Inter-Tribal
                                                Office of Water, Washington, DC https://                Agency, Office of Water, Washington, DC EPA–822–      Fish Commission (CRITFC), 1994)



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                                                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

                                                                                                                         Cancer                Relative
                                                                                                                      slope factor,                            Reference              Bio-accumulation               Bio-concentration               Water &                 Organisms
                                                                                                                                               source
                                                                     Chemical                              CAS No.        CSF                                  dose, RfD                    factor                         factor                   organisms                   only
                                                                                                                                             contribution,
                                                                                                                        (per mg/                               (mg/kg·d)                (L/kg tissue)                  (L/kg tissue)                  (μg/L)                   (μg/L)
                                                                                                                                               RSC (-)
                                                                                                                          kg·d)

                                                                                                                            (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) Ether *                      108601   ....................           0.50                  0.04                               10     ............................               400                        900
                                                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
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                                                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



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                                                                        Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                                                                                                            85431

                                                                                                       TABLE 1—HUMAN HEALTH CRITERIA FOR WASHINGTON—Continued
                                                                                     A                                                                                                  B                                                                                          C

                                                                                                                                   Cancer                Relative
                                                                                                                                slope factor,                            Reference              Bio-accumulation               Bio-concentration               Water &                 Organisms
                                                                                                                                                         source
                                                                      Chemical                               CAS No.                CSF                                  dose, RfD                    factor                         factor                   organisms                   only
                                                                                                                                                       contribution,
                                                                                                                                  (per mg/                               (mg/kg·d)                (L/kg tissue)                  (L/kg tissue)                  (μg/L)                   (μg/L)
                                                                                                                                                         RSC (-)
                                                                                                                                    kg·d)

                                                                                                                                      (B1)                 (B2)               (B3)                        (B4)                           (B5)                      (C1)                    (C2)

                                                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 (PCBs)                       ................                     2               -     ....................    ............................                    31,200              c 7E–06                    c 7E–06

                                                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                                                        Revisions to the Methodology for                                                   Although EPA revises and establishes
                                                                                                                                    Deriving Ambient Water Quality Criteria                                            new human health criteria for
                                                   These new and revised human health
                                                                                                                                    for the Protection of Human Health (65                                             Washington in this final rule,
                                                criteria apply for CWA purposes in
                                                                                                                                    FR 66444, November 3, 2000), EPA now                                               Washington continues to have the
                                                addition to any existing criteria already
                                                                                                                                    recommends harmonic mean flow be                                                   option to adopt and submit to EPA
                                                applicable to Washington’s waters,
                                                                                                                                    used to implement human health                                                     human health criteria for the pollutants
                                                including the state’s narrative toxics
                                                                                                                                    criteria for both carcinogens and non-                                             in this final rule, consistent with CWA
                                                criteria statement at WAC 173–201A–
                                                                                                                                    carcinogens.67 EPA received one                                                    section 303(c) and EPA’s implementing
                                                260(2)(a), and those human health
                                                                                                                                    comment on this provision, asking for                                              regulations at 40 CFR part 131.
                                                criteria that Washington submitted on
                                                                                                                                    clarification on whether this is                                                      In its September 14, 2015 proposed
                                                August 1, 2016, and EPA approved
                                                                                                                                    consistent with Washington’s current                                               rule, EPA proposed that if Washington
                                                concurrent with this final rule.
                                                                                                                                    permitting approach of using the 30Q5                                              adopted and submitted human health
                                                   EPA replicates in 40 CFR 131.45 the
                                                                                                                                    flow for non-carcinogens.68 In response,                                           criteria, and EPA approved those
                                                same general rules of applicability for
                                                                                                                                    Washington’s use of low flow statistics                                            criteria before finalizing its federal rule,
                                                human health criteria as in 40 CFR
                                                                                                                                    more stringent than the harmonic mean                                              EPA would not proceed with finalizing
                                                131.36(c), with one exception. For
                                                                                                                                    flow is consistent with EPA’s final rule.
                                                waters suitable for the establishment of                                                                                                                               those criteria and Washington’s
                                                                                                                                       Under the CWA, Congress gave states
                                                low flow return frequencies (i.e.,                                                                                                                                     approved criteria would be solely
                                                                                                                                    primary responsibility for developing
                                                streams and rivers), this final rule                                                                                                                                   applicable for CWA purposes. EPA did
                                                                                                                                    and adopting WQS for their navigable
                                                provides that Washington must not use                                                                                                                                  not receive any comments opposing this
                                                                                                                                    waters (CWA section 303(a)-(c)).
                                                a low flow value below which numeric                                                                                                                                   provision, thus EPA is proceeding with
                                                standards can be exceeded that is less                                                                                                                                 such an approach. In this final rule, EPA
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                                                                                                                                       67 See also USEPA. 2014. Water Quality
                                                stringent than the harmonic mean flow                                               Standards Handbook—Chapter 5: General Policies.                                    is withdrawing Washington from the
                                                (a long-term mean flow value calculated                                             U.S. Environmental Protection Agency. Office of                                    NTR at 40 CFR 131.36, and, with the
                                                by dividing the number of daily flows                                               Water. Washington, DC EPA–820–B–14–004.                                            exception of criteria for which EPA has
                                                analyzed by the sum of the reciprocals                                              https://www.epa.gov/wqs-tech/water-quality-                                        approved Washington’s criteria, EPA is
                                                                                                                                    standards-handbook.
                                                of those daily flows), so that the criteria                                            68 The 30Q5 flow is the lowest 30-day average                                   incorporating the Washington-specific
                                                are implemented to be protective of the                                             flow event expected to occur once every five years,                                criteria in this rule (as well as the
                                                applicable designated use. Per the                                                  on average (determined hydrologically).                                            existing NTR criteria for arsenic, dioxin


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                                                85432            Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                and thallium) into 40 CFR 131.45 so                     pollutant(s) or water quality                         final rule change, any of the flexibilities
                                                there is a single comprehensive set of                  parameter(s) that reflect the highest                 already afforded to Washington by
                                                federally promulgated criteria for                      attainable conditions during the term of              EPA’s regulations to modify or remove
                                                Washington. Therefore, the CWA-                         the WQS variances. WQS variances                      designated uses, adopt variances, issue
                                                effective numeric human health criteria                 adopted in accordance with 40 CFR part                compliance schedules, or establish site-
                                                in Washington consist of the federally                  131 allow states and authorized tribes to             specific criteria. These implementation
                                                promulgated criteria at 40 CFR 131.45                   address water quality challenges in a                 tools are important for making
                                                and those criteria that EPA approved at                 transparent and predictable way.                      incremental progress and allowing the
                                                WAC 173–201A–240 in Washington’s                        Variances help states and authorized                  time for adaptive management when
                                                August 1, 2016 submittal.                               tribes focus on making incremental                    designated uses and associated criteria
                                                   Additionally, in its September 14,                   progress in improving water quality,                  are difficult to attain. Washington may
                                                2015 proposed rule, EPA proposed that                   rather than pursuing a downgrade of the               continue to use any of these regulatory
                                                if Washington adopted and submitted                     underlying water quality goals through                flexibilities when implementing the
                                                human health criteria after EPA                         a designated use change, when the                     final federal human health criteria.
                                                finalized its rule, once EPA approved                   designated use is not attainable
                                                Washington’s WQS, the pollutant-                                                                              a. Designating Uses
                                                                                                        throughout the term of the variance due
                                                specific or site-specific EPA-approved                  to one of the factors listed in 40 CFR                   EPA’s final human health criteria
                                                criteria in Washington’s WQS would                      131.14. EPA’s regulations at 40 CFR                   apply to waters that Washington has
                                                become the solely effective criteria for                122.47 provide the requirements when                  designated for the following: Fresh
                                                CWA purposes and EPA’s promulgated                      states and authorized tribes wish to                  waters—Harvesting (fish harvesting),
                                                criteria for those pollutants or for that               include permit compliance schedules in                Domestic Water (domestic water
                                                site would no longer apply. A few                       their NPDES permits if dischargers need               supply), and Recreational Uses; Marine
                                                commenters supported this provision,                    additional time to meet their water                   waters—Shellfish Harvesting
                                                where Washington’s criteria for specific                quality-based limits based on the                     (shellfish—clam, oyster, and mussel—
                                                pollutants or sites become the only                     applicable WQS. EPA’s updated                         harvesting), Harvesting (salmonid and
                                                CWA-effective criteria upon EPA’s                       regulations at 40 CFR 131.15 require any              other fish harvesting, and crustacean
                                                approval, without any delay caused by                   state or authorized tribe wishing to use              and other shellfish—crabs, shrimp,
                                                EPA’s withdrawal of the corresponding                   permit compliance schedules to also                   scallops, etc.—harvesting), and
                                                federal criteria. A few other commenters                include provisions authorizing the use                Recreational Uses (see WAC 173–201A–
                                                did not support this provision, and                     of permit compliance schedules after                  600 and WAC 173–201A–610). If
                                                asked that EPA either delete the                        appropriate public involvement to                     Washington removes the Domestic
                                                provision, or make clear that criteria                  ensure that a decision to allow permit                Water use but retains any of the other
                                                adopted by the state would have to be                   compliance schedules derives from and                 above designated uses for any particular
                                                at least as stringent as the federal                    complies with the applicable WQS. (80                 waterbody affected by this final rule,
                                                criteria for EPA to approve and make                    FR 51022, August 21, 2015).                           and EPA finds that removal to be
                                                the state criteria effective for CWA                       40 CFR 131.10 specifies how states                 consistent with CWA section 303(c) and
                                                purposes. Upon further consideration of                 and authorized tribes establish, modify               EPA’s implementing regulations at 40
                                                comments received on its proposed rule,                 or remove designated uses for their                   CFR part 131, then the federal organism-
                                                EPA decided not to finalize this                        waters. 40 CFR 131.11 specifies the                   only criteria will apply in place of the
                                                provision. Pursuant to 40 CFR 131.21(c),                requirements for establishing criteria to             federal water-plus-organism criteria. If
                                                EPA’s federally promulgated WQS are                     protect designated uses, including                    Washington removes designated uses
                                                and will be applicable for purposes of                  criteria modified to reflect site-specific            such that none of the above uses apply
                                                the CWA until EPA withdraws those                       conditions. In the context of this                    to any particular waterbody affected by
                                                federally promulgated WQS. EPA would                    rulemaking, a site-specific criterion                 this final rule and adopts the highest
                                                undertake such a rulemaking to                          (SSC) is an alternative value to the                  attainable use, as defined by 40 CFR
                                                withdraw the federal criteria if and                    federal human health criteria that could              131.3(m), consistent with 40 CFR
                                                when Washington adopts and EPA                          be applied on a watershed, area-wide, or              131.10(g), and EPA finds that removal to
                                                approves corresponding criteria that                    waterbody-specific basis that meets the               be consistent with CWA section 303(c)
                                                meet the requirements of section 303(c)                 regulatory test of protecting the                     and EPA’s implementing regulations at
                                                of the CWA and EPA’s implementing                       designated use, being scientifically                  40 CFR part 131, then the federal human
                                                regulations at 40 CFR part 131.                         defensible, and ensuring the protection               health criteria will no longer apply to
                                                                                                        and maintenance of downstream WQS.                    that waterbody. Instead, any criteria
                                                F. Alternative Regulatory Approaches
                                                                                                        A SSC may be more or less stringent                   associated with the newly designated
                                                and Implementation Mechanisms
                                                                                                        than the otherwise applicable federal                 highest attainable use would apply to
                                                  Washington has considerable                           criterion. A SSC may be appropriate                   that waterbody.
                                                discretion to implement these revised                   when further scientific data and
                                                and new federal human health criteria                                                                         b. Variances and Compliance Schedules
                                                                                                        analyses can bring added precision to
                                                through various water quality control                   express the concentration of a particular                EPA’s final human health criteria
                                                programs including the NPDES                            pollutant that protects the human                     apply to use designations that
                                                program, which limits discharges to                     health-related designated use in a                    Washington has already established.
                                                waters except in compliance with a                      particular waterbody.                                 Concurrent with this final rule, EPA
                                                NPDES permit. EPA’s regulations at 40                      A few commenters supported EPA’s                   approved revisions to Washington’s
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                                                CFR 131.14 authorize states and                         acknowledgement of the flexibilities                  variance and compliance schedule
                                                authorized tribes to adopt WQS                          that Washington has available when                    authorizing provisions. Washington may
                                                variances to provide time to achieve the                implementing the final criteria in this               use its EPA-approved variance
                                                applicable WQS. 40 CFR part 131                         rule, while others commented that these               procedures (see WAC 173–201A–420) to
                                                defines WQS variances at 131.3(o) as                    tools allow Washington to delay or                    establish time-limited designated uses
                                                time-limited designated uses and                        avoid implementing the criteria. EPA                  and criteria to apply for the purposes
                                                supporting criteria for a specific                      did not propose to change, nor does this              specified in 40 CFR 131.14 as it pertains


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                                                                      Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                                                                    85433

                                                to federal criteria when adopting such                                      criteria in this final rule for the purpose                              into compliance with the revised
                                                variances. Washington has sufficient                                        of transparency and presents this                                        criteria; EPA did not fully evaluate the
                                                authority to use variances when                                             information reflecting the potential                                     potential for costs to nonpoint
                                                implementing the human health criteria                                      economic effects of the rule.                                            sources,69 such as agricultural runoff,
                                                as long as such variances are adopted                                          These WQS may serve as a basis for                                    that could be incurred under a TMDL
                                                consistent with 40 CFR 131.14, and                                          development of NPDES permit limits.                                      for this analysis, but did analyze the
                                                submitted to EPA for review under                                           Washington has NPDES permitting                                          administrative costs to the state of
                                                CWA section 303(c). Similarly,                                              authority, and retains considerable                                      preparing TMDLs for potentially
                                                Washington may use its EPA-approved                                         discretion in implementing standards.                                    incrementally impaired waters. Actual
                                                regulation authorizing the use of permit                                    EPA evaluated the potential costs to                                     costs of implementation of TMDLs is
                                                compliance schedules (see WAC 173–                                          NPDES dischargers associated with state                                  beyond the scope of this analysis.
                                                201A–510(4)), consistent with 40 CFR                                        implementation of EPA’s final criteria.
                                                131.15, to grant compliance schedules,                                                                                                               A. Identifying Affected Entities
                                                                                                                            This analysis is documented in Final
                                                as appropriate, for WQBELs based on                                         Economic Analysis for the Revision of                                       EPA identified 406 point source
                                                the federal criteria. These state                                           Certain Federal Water Quality Criteria                                   facilities that could ultimately be
                                                regulations are not affected by this final                                  Applicable to Washington, which can be                                   affected by this final rule. Of these
                                                rule.                                                                       found in the record for this rulemaking.                                 potentially affected facilities, 73 are
                                                c. Site-Specific Criteria                                                      Any NPDES-permitted facility that                                     major dischargers and 333 are minor
                                                   As discussed in section III.E, if                                        discharges pollutants for which the                                      dischargers. EPA did not include
                                                Washington adopts and EPA approves                                          revised human health criteria are more                                   general permit facilities in its analysis
                                                site-specific criteria that fully meet the                                  stringent than the applicable aquatic life                               because data for such facilities are
                                                requirements of section 303(c) of the                                       criteria (or for which human health                                      limited, and flows are usually
                                                CWA and EPA’s implementing                                                  criteria are the only applicable criteria)                               negligible. Of the potentially affected
                                                regulations at 40 CFR part 131, EPA will                                    could potentially incur compliance                                       facilities, EPA evaluated a sample of 17
                                                undertake a rulemaking to withdraw the                                      costs. The types of affected facilities                                  major facilities. Minor facilities are
                                                corresponding federal criteria.                                             could include industrial facilities and                                  unlikely to incur costs as a result of
                                                                                                                            POTWs discharging wastewater to                                          implementation of the rule, because
                                                IV. Economic Analysis                                                       surface waters (i.e., point sources). EPA                                minor facilities are typically those that
                                                  Under the CWA, water quality criteria                                     did not attribute compliance with water                                  do not discharge toxics in toxic amounts
                                                are set on the basis of the latest                                          quality-based effluent limitations                                       and discharge less than 1 million
                                                scientific knowledge. EPA is not                                            (WQBELs) reflective of existing federal                                  gallons per day (mgd). Although lower
                                                required under the CWA nor obligated                                        human health criteria applicable to                                      human health criteria could potentially
                                                under Executive Orders 12866 and                                            Washington (hereafter referred to as                                     change this categorization, EPA did not
                                                13563 to conduct an economic analysis                                       ‘‘baseline criteria’’) to the final rule.                                have effluent data on toxic pollutants to
                                                of the criteria. Costs cannot be                                            Once in compliance with WQBELs                                           evaluate minor facilities for this
                                                considered in establishing water quality                                    reflective of baseline criteria, EPA                                     analysis. Table 2 summarizes these
                                                criteria as part of WQS. Nonetheless,                                       expects that dischargers will continue to                                potentially affected facilities by type
                                                EPA conducted a cost analysis for the                                       use the same types of controls to come                                   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                                              baseline permit conditions, reasonable                                   would be needed above the baseline
                                                  EPA evaluated the two major                                               potential to exceed human health                                         level of controls are attributable to the
                                                municipal facilities with design flows                                      criteria based on the final rule, and                                    final rule.
                                                greater than 100 mgd and a large                                            potential to exceed projected effluent                                      EPA assumed that dischargers will
                                                industrial refinery, to attempt to capture                                  limitations based on the last three years                                pursue the least cost means of
                                                the facilities with the potential for the                                   of effluent monitoring data (if available).                              compliance with WQBELs. Incremental
                                                largest costs. For the remaining major                                      In instances of exceedances of projected                                 compliance actions attributable to the
                                                facilities, EPA evaluated a random                                          effluent limitations under the final                                     final rule may include pollution
                                                sample of facilities to represent                                           criteria, EPA determined the likely                                      prevention, end-of-pipe treatment, and
                                                discharger type and category. For all                                       compliance scenarios and costs. Only                                     alternative compliance mechanisms
                                                sample facilities, EPA evaluated existing                                   compliance actions and costs that                                        (e.g., variances). EPA annualized one-
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                                                  69 The CWA does not regulate nonpoint sources.                            pollutants of concern after dischargers have                             sediment) may be a source of ongoing loading.
                                                However, EPA recognizes that the state may require                          implemented controls to meet current WQS, total                          Atmospheric deposition may also contribute
                                                controls for nonpoint sources as part of potential                          maximum daily loads (TMDLs) for impaired waters,                         loadings of the pollutants of concern (e.g., mercury).
                                                incremental TMDLs. It is difficult to model and                             or other water quality improvement plans, are not                        EPA did not estimate sediment remediation costs,
                                                evaluate the potential cost impacts of this final rule                      available. Therefore, trying to determine which
                                                                                                                                                                                                     or air pollution controls costs, for this analysis
                                                to nonpoint sources because they are intermittent,                          sources would not achieve WQS based on the
                                                variable, and occur under hydrologic or climatic                            revised human health criteria after complying with                       because EPA did not have data on the contribution
                                                conditions associated with precipitation events.                            existing regulations and policies may not be                             of these sources, and because control costs for
                                                Also, data on instream and discharge levels of the                          possible. In addition, legacy contamination (e.g., in                    deposition may be covered by Clean Air Act rules.



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                                                85434            Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                time costs (capital costs and variance                  requirements, and thus different costs,               C. Regulatory Flexibility Act
                                                costs) over 20 years using a 3 percent                  for point sources.                                       I certify that this action will not have
                                                discount rate to obtain total annual costs                If the net increase in potential                    a significant economic impact on a
                                                per facility. For the random sample,                    impairments is any indication of the                  substantial number of small entities
                                                EPA extrapolated the annualized costs                   potential increase in the number of                   under the RFA. This action will not
                                                based on the sampling weight for each                   TMDLs, then the total administrative                  impose any requirements on small
                                                sample facility. To obtain an estimate of               costs for TMDL development could be                   entities. EPA has the authority to
                                                total costs to point sources, EPA added                 in the range of $2.7 million to $3.0                  promulgate WQS in any case where the
                                                the results for the certainty sample to                 million based on national average                     Administrator determines that a new or
                                                the extrapolated random sample costs.                   single-cause single-waterbody TMDL                    revised standard is necessary to meet
                                                C. Results                                              development costs from U.S. EPA (2001;                the requirements of the CWA. EPA-
                                                                                                        updated to 2014 dollars). However,                    promulgated standards are implemented
                                                   Based on the results for 17 sample                   these costs may be reduced if Ecology
                                                facilities across 8 industrial and                                                                            through various water quality control
                                                                                                        develops multi-cause or multi-                        programs including the NPDES
                                                municipal categories,70 EPA estimated a                 waterbody TMDLs. If these costs are
                                                total annual compliance cost of                                                                               program, which limits discharges to
                                                                                                        spread over 8 to 15 years, at a discount              navigable waters except in compliance
                                                approximately $126,000 to $150,000 for                  rate of 3 percent, the annualized costs
                                                all major dischargers in the state (using                                                                     with an NPDES permit. The CWA
                                                                                                        of developing TMDLs are $229,000 to                   requires that all NPDES permits include
                                                a 3 percent discount rate). Only five                   $422,000.
                                                facilities are estimated to incur                                                                             any limits on discharges that are
                                                                                                          Combining the potential facility
                                                pollution prevention program costs,                                                                           necessary to meet applicable WQS.
                                                                                                        compliance costs and TMDL
                                                while two facilities are expected to also                                                                     Thus, under the CWA, EPA’s
                                                                                                        administrative costs results in total
                                                incur costs of obtaining a variance. Most                                                                     promulgation of WQS establishes
                                                                                                        annual costs of $355,000 to $572,000, at
                                                of the facilities would not bear any cost.                                                                    standards that the state implements
                                                                                                        a 3 percent discount rate.
                                                The low end of the range reflects the                                                                         through the NPDES permit process. The
                                                assumption that the compliance actions                  V. Statutory and Executive Order                      state has discretion in developing
                                                (e.g., pollution prevention) will result in             Reviews                                               discharge limits, as needed to meet the
                                                compliance with projected effluent                                                                            standards. As a result of this action, the
                                                                                                        A. Executive Order 12866 (Regulatory
                                                limits, whereas the high scenario                                                                             State of Washington will need to ensure
                                                                                                        Planning and Review) and Executive
                                                reflects projected effluent limits not                                                                        that permits it issues include any
                                                                                                        Order 13563 (Improving Regulation and
                                                being met, and thus includes the                                                                              limitations on discharges necessary to
                                                                                                        Regulatory Review)
                                                estimated administrative cost of also                                                                         comply with the standards established
                                                obtaining a variance. All compliance                      It has been determined that this final              in the final rule. In doing so, the state
                                                costs are for industrial facilities, and are            rule is not a ‘‘significant regulatory                will have a number of choices
                                                attributable to the human health                        action’’ under the terms of Executive                 associated with permit writing. While
                                                criterion for methylmercury.                            Order 12866 (58 FR 51735, October 4,                  Washington’s implementation of the
                                                   If the revised criteria result in an                 1993) and is, therefore, not subject to               rule may ultimately result in new or
                                                incremental increase in impaired                        review under Executive Orders 12866                   revised permit conditions for some
                                                waters, resulting in the need for TMDL                  and 13563 (76 FR 3821, January 21,                    dischargers, including small entities,
                                                development, there could also be some                   2011). The final rule does not establish              EPA’s action, by itself, does not impose
                                                costs to nonpoint sources of pollution.                 any requirements directly applicable to               any of these requirements on small
                                                Using available ambient monitoring                      regulated entities or other sources of                entities; that is, these requirements are
                                                data, EPA compared pollutant                            toxic pollutants. However, these WQS                  not self-implementing.
                                                concentrations to the baseline and final                may serve as a basis for development of
                                                criteria, identifying waterbodies that                  NPDES permit limits. Washington has                   D. Unfunded Mandates Reform Act
                                                may be incrementally impaired (i.e.,                    NPDES permitting authority, and retains                  This action contains no federal
                                                impaired under the final criteria but not               considerable discretion in implementing               mandates under the provisions of Title
                                                under the baseline). For the parameters                 standards. In the spirit of Executive                 II of the Unfunded Mandates Reform
                                                and stations for which EPA had                          Order 12866, EPA evaluated the                        Act of 1995 (UMRA), 2 U.S.C. 1531–
                                                sufficient monitoring data available to                 potential costs to NPDES dischargers                  1538 for state, local, or tribal
                                                evaluate, there were 50 impairments                     associated with state implementation of               governments or the private sector. As
                                                under the baseline criteria and 124                     EPA’s final criteria. This analysis, Final            these water quality criteria are not self-
                                                under the final criteria, for a total of 74             Economic Analysis for the Revision of                 implementing, EPA’s action imposes no
                                                potential incremental impairments (or a                 Certain Federal Water Quality Criteria                enforceable duty on any state, local or
                                                148 percent increase relative to the                    Applicable to Washington, is                          tribal governments or the private sector.
                                                baseline; including for methylmercury,                  summarized in section IV of the                       Therefore, this action is not subject to
                                                PCBs, and DDT). This increase indicates                 preamble and is available in the docket.              the requirements of sections 202 or 205
                                                the potential for nonpoint sources to                                                                         of UMRA.
                                                bear some compliance costs, although                    B. Paperwork Reduction Act
                                                                                                                                                                 This action is also not subject to the
                                                data are not available to estimate the                    This action does not impose any                     requirements of section 203 of UMRA
                                                magnitude of these costs. The control of                direct new information collection                     because it contains no regulatory
                                                nonpoint sources such as in the context                 burden under the provisions of the                    requirements that could significantly or
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                                                of a TMDL could result in different                     Paperwork Reduction Act, 44 U.S.C.                    uniquely affect small governments.
                                                                                                        3501 et seq. Actions to implement these
                                                  70 Seven industrial categories (mining, food and      WQS could entail additional paperwork                 E. Executive Order 13132 (Federalism)
                                                kindred products, paper and allied products,            burden. Burden is defined at 5 CFR                      This action does not have federalism
                                                chemicals and allied products, petroleum refining
                                                and related industries, primary metal industries,
                                                                                                        1320.3(b). This action does not include               implications. It will not have substantial
                                                and transportation and public utilities (except         any information collection, reporting, or             direct effects on the states, on the
                                                POTWs)) and municipal POTWs.                            record-keeping requirements.                          relationship between the national


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                                                                 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                              85435

                                                government and the states, or on the                    have also met regularly since November                I. National Technology Transfer and
                                                distribution of power and                               2012 to discuss Washington’s human                    Advancement Act of 1995
                                                responsibilities among the various                      health criteria at both the tribal                       This final rulemaking does not
                                                levels of government. This rule does not                leadership level and technical staff                  involve technical standards.
                                                alter Washington’s considerable                         level. The tribes have repeatedly asked
                                                discretion in implementing these WQS,                   EPA to promulgate federal human                       J. Executive Order 12898 (Federal
                                                nor will it preclude Washington from                    health criteria for Washington if the                 Actions To Address Environmental
                                                adopting WQS in the future that EPA                     state did not do so in a timely and                   Justice in Minority Populations and
                                                concludes meet the requirements of the                                                                        Low-Income Populations)
                                                                                                        protective manner. At these meetings,
                                                CWA, which will eliminate the need for                                                                           This action will not have
                                                                                                        the tribes consistently emphasized that
                                                federal standards. Thus, Executive                                                                            disproportionately high and adverse
                                                                                                        the human health criteria should be
                                                Order 13132 does not apply to this                                                                            human health or environmental effects
                                                action.                                                 derived using at least a minimum FCR
                                                                                                        value of 175 g/day, a cancer risk level               on minority or low-income populations.
                                                F. Executive Order 13175 (Consultation                  of 10¥6, and the latest scientific                    Conversely, this action identifies and
                                                and Coordination With Indian Tribal                     information from EPA’s 304(a)                         ameliorates disproportionately high and
                                                Governments)                                            recommended criteria. EPA considered                  adverse human health effects on
                                                                                                        the input received during consultation                minority populations and low-income
                                                   This action has tribal implications.
                                                                                                                                                              populations in Washington. EPA
                                                However, it will neither impose                         with tribes when developing this final
                                                substantial direct compliance costs on                                                                        developed the human health criteria
                                                                                                        rule (see section III for additional
                                                federally recognized tribal governments,                                                                      included in this final rule specifically to
                                                                                                        discussion of how EPA considered tribal               protect Washington’s designated uses,
                                                nor preempt tribal law. In the State of                 input).
                                                Washington, there are 29 federally                                                                            using the most current science,
                                                                                                           In subsequent coordination with                    including local and regional information
                                                recognized Indian tribes. To date, nine
                                                of these Indian tribes have been                        tribes, EPA received a letter on August               on fish consumption. Applying these
                                                approved for TAS for CWA sections 303                   5, 2016, from the Northwest Indian                    criteria to waters in the State of
                                                and 401.71 Of these nine tribes, seven                  Fisheries Commission disagreeing with                 Washington will afford a greater level of
                                                have EPA-approved WQS in their                          EPA’s potential adjustments to the RSC                protection to both human health and the
                                                respective jurisdictions.72 This rule                   from the proposed rule issued on                      environment.
                                                could affect federally recognized Indian                September 14, 2015 to the final rule as               K. Congressional Review Act (CRA)
                                                tribes in Washington because the                        a result of public comments. The tribes
                                                                                                        expressed concern that less stringent                   This action is subject to the CRA, and
                                                numeric criteria for Washington will
                                                                                                        human health criteria as a result of the              EPA will submit a rule report to each
                                                apply to waters adjacent to (or upstream
                                                                                                                                                              House of the Congress and to the
                                                or downstream of) the tribal waters,                    RSC adjustment would result in lower
                                                where many of those tribes have treaty                                                                        Comptroller General of the United
                                                                                                        protection of designated uses and limit
                                                rights to take fish for their subsistence.                                                                    States. This action is not a ‘‘major rule’’
                                                                                                        the ability to exercise tribal treaty rights,         as defined by 5 U.S.C. 804(2).
                                                Additionally, there are ten federally                   especially in light of a FCR that
                                                recognized Indian tribes in the                         underestimates tribal consumption. EPA                List of Subjects in 40 CFR Part 131
                                                Columbia River Basin located in the                     considered this information carefully                   Environmental protection, Indians-
                                                states of Oregon and Idaho that this rule               before finalizing this rule, but for the              lands, Intergovernmental relations,
                                                could impact because their waters could                 reasons stated above, decided to adjust               Reporting and recordkeeping
                                                affect or be affected by the water quality              the RSC to account for inclusion of                   requirements, Water pollution control.
                                                of Washington’s downstream or
                                                                                                        some marine fish in the FCR. This                       Dated: November 15, 2016.
                                                upstream waters.
                                                   EPA consulted with federally                         results in protective criteria that account           Gina McCarthy,
                                                recognized tribal officials under EPA’s                 for other routes of exposure in addition              Administrator.
                                                Policy on Consultation and                              to drinking water and fish and shellfish
                                                                                                        from inland and nearshore waters and is                 For the reasons set forth in the
                                                Coordination with Indian Tribes early in
                                                                                                        consistent with EPA’s guidance.                       preamble, EPA amends 40 CFR part 131
                                                the process of developing this rule to
                                                                                                                                                              as follows:
                                                permit them to have meaningful and                      G. Executive Order 13045 (Protection of
                                                timely input into its development. In                   Children From Environmental Health                    PART 131—WATER QUALITY
                                                February and March 2015, EPA held                                                                             STANDARDS
                                                                                                        and Safety Risks)
                                                tribes-only technical staff and
                                                leadership consultation sessions to hear                  This rule is not subject to Executive               ■ 1. The authority citation for part 131
                                                their views and answer questions of all                 Order 13045, because it is not                        continues to read as follows:
                                                interested tribes on the proposed rule.                 economically significant as defined in                    Authority: 33 U.S.C. 1251 et seq.
                                                Representatives from approximately 23                   Executive Order 12866, and because the
                                                tribes and four tribal consortia                        environmental health or safety risks                  Subpart D—Federally Promulgated
                                                participated in two leadership meetings                                                                       Water Quality Standards
                                                                                                        addressed by this action do not present
                                                held in March 2015. EPA and tribes
                                                                                                        a disproportionate risk to children.                  § 131.36    [Amended]
                                                  71 http://water.epa.gov/scitech/swguidance/
                                                                                                        H. Executive Order 13211 (Actions That                ■ 2. In § 131.36, remove paragraph
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                                                standards/wqslibrary/approvtable.cfm.
                                                  72 http://yosemite.epa.gov/r10/water.nsf/
                                                                                                        Significantly Affect Energy Supply,                   (d)(14).
                                                34090d07b77d50bd88256b79006529e8/dd2a4                  Distribution, or Use)                                 ■ 3. Add § 131.45 to read as follows:
                                                df00fd7ae1a88256e0500680e86!OpenDocument.
                                                Note that this number does not include the                This action is not a ‘‘significant                  § 131.45 Revision of certain Federal water
                                                Confederated Tribes of the Colville Reservation,        energy action’’ because it is not likely to           quality criteria applicable to Washington.
                                                which has federally promulgated WQS from 1989.
                                                EPA is currently reviewing the Colville Tribe’s         have a significant adverse effect on the                (a) Scope. This section promulgates
                                                application for TAS.                                    supply, distribution, or use of energy.               human health criteria for priority toxic


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                                                85436                  Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                pollutants in surface waters in                                             (b) Criteria for priority toxic                                                  applicable human health criteria are
                                                Washington.                                                               pollutants in Washington. The                                                      shown in Table 1.
                                                                                                              TABLE 1—HUMAN HEALTH CRITERIA FOR WASHINGTON
                                                                                   A                                                                                          B                                                                                          C

                                                                                                                         Cancer                Relative
                                                                                                                      slope factor,                            Reference              Bio-accumulation               Bio-concentration               Water &                 Organisms
                                                                                                                                               source
                                                                     Chemical                              CAS No.        CSF                                  dose, RfD                    factor                         factor                   organisms                   only
                                                                                                                                             contribution,
                                                                                                                        (per mg/                               (mg/kg·d)                (L/kg tissue)                  (L/kg tissue)                  (μg/L)                   (μg/L)
                                                                                                                                               RSC (-)
                                                                                                                          kg·d)

                                                                                                                            (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) Ether *                      108601   ....................           0.50                  0.04                               10     ............................               400                        900
                                                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
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                                                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



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                                                                        Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                                                                                                            85437

                                                                                                       TABLE 1—HUMAN HEALTH CRITERIA FOR WASHINGTON—Continued
                                                                                     A                                                                                                  B                                                                                          C

                                                                                                                                   Cancer                Relative
                                                                                                                                slope factor,                            Reference              Bio-accumulation               Bio-concentration               Water &                 Organisms
                                                                                                                                                         source
                                                                      Chemical                               CAS No.                CSF                                  dose, RfD                    factor                         factor                   organisms                   only
                                                                                                                                                       contribution,
                                                                                                                                  (per mg/                               (mg/kg·d)                (L/kg tissue)                  (L/kg tissue)                  (μg/L)                   (μg/L)
                                                                                                                                                         RSC (-)
                                                                                                                                    kg·d)

                                                                                                                                      (B1)                 (B2)               (B3)                        (B4)                           (B5)                      (C1)                    (C2)

                                                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 (PCBs)                       ................                     2              -      ....................    ............................                    31,200              c 7E-06                    c 7E-06

                                                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                                           establishment of low flow return                                                     (B) Recreational uses;
                                                paragraph (b) of this section apply to                                              frequencies (i.e., streams and rivers).                                              (C) Shellfish harvesting: Shellfish
                                                waters with Washington’s designated                                                 Harmonic mean flow is a long-term                                                  harvest (Shellfish (clam, oyster, and
                                                uses cited in paragraph (d) of this                                                 mean flow value calculated by dividing                                             mussel) harvesting)
                                                section and apply concurrently with                                                 the number of daily flows analyzed by
                                                other applicable water quality criteria.                                            the sum of the reciprocals of those daily                                            Note to paragraph (d)(1): The source of
                                                   (2) The criteria established in this                                             flows.                                                                             these uses is Washington Administrative
                                                section are subject to Washington’s                                                    (iii) If the state does not have such a                                         Code 173–201A–600 for Fresh waters and
                                                general rules of applicability in the                                               low flow value for numeric criteria, then                                          173–201A–610 for Marine waters.
                                                same way and to the same extent as are                                              none will apply and the criteria in
                                                other federally promulgated and state-                                                                                                                                   (2) For Washington waters that
                                                                                                                                    paragraph (b) of this section herein
                                                adopted numeric criteria when applied                                                                                                                                  include the use classification of
                                                                                                                                    apply at all flows.
                                                to the same use classifications in                                                     (d) Applicable use designations. (1)                                            Domestic Water, the criteria in column
                                                paragraph (d) of this section.                                                      All waters in Washington assigned to                                               C1 and the methylmercury criterion in
                                                   (i) For all waters with mixing zone                                              the following use classifications are                                              column C2 of Table 1 in paragraph (b)
                                                regulations or implementation                                                       subject to the criteria identified in                                              of this section apply. For Washington
                                                procedures, the criteria apply at the                                               paragraph (d)(2) of this section:                                                  waters that include any of the following
                                                appropriate locations within or at the                                                 (i) Fresh waters—                                                               use classifications but do not include
                                                boundary of the mixing zones;                                                          (A) Miscellaneous uses: Harvesting                                              the use classification of Domestic Water,
                                                otherwise the criteria apply throughout                                             (Fish harvesting);                                                                 the criteria in column C2 of Table 1 in
                                                the waterbody including at the end of                                                  (B) Recreational uses;                                                          paragraph (b) of this section apply:
                                                any discharge pipe, conveyance or other                                                (C) Water supply uses: Domestic                                                 Harvesting (fresh and marine waters),
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                                                discharge point within the waterbody.                                               water (Domestic water supply);                                                     Recreational Uses (fresh and marine
                                                   (ii) The state must not use a low flow                                              (ii) Marine waters—                                                             waters), and Shellfish Harvesting.
                                                value below which numeric non-                                                         (A) Miscellaneous uses: Harvesting
                                                                                                                                                                                                                       [FR Doc. 2016–28424 Filed 11–25–16; 8:45 am]
                                                carcinogen and carcinogen human                                                     (Salmonid and other fish harvesting,
                                                health criteria can be exceeded that is                                             and crustacean and other shellfish                                                 BILLING CODE 6560–50–P
                                                less stringent than the harmonic mean                                               (crabs, shrimp, scallops, etc.)
                                                flow for waters suitable for the                                                    harvesting);


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Document Created: 2018-02-14 08:35:32
Document Modified: 2018-02-14 08:35:32
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis final rule is effective on December 28, 2016.
ContactErica Fleisig, Office of Water, Standards and Health Protection Division (4305T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460;
FR Citation81 FR 85417 
RIN Number2040-AF56
CFR AssociatedEnvironmental Protection; Indians-Lands; Intergovernmental Relations; Reporting and Recordkeeping Requirements and Water Pollution Control

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