Revision of Certain Federal Water Quality Criteria Applicable to Washington, 85417-85437 [2016-28424]
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Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the CAA; and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where EPA or an
Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the rule does not have
tribal implications as specified by
Executive Order 13175 (65 FR 67249,
November 9, 2000), nor will it impose
substantial direct costs on tribal
governments or preempt tribal law.
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
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copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
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the U.S. House of Representatives, and
the Comptroller General of the United
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This action is not a ‘‘major rule’’ as
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Under section 307(b)(1) of the CAA,
petitions for judicial review of this
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affect the finality of this action for the
purposes of judicial review nor does it
extend the time within which a petition
for judicial review may be filed, and
shall not postpone the effectiveness of
such rule or action. This action may not
be challenged later in proceedings to
enforce its requirements. See section
307(b)(2).
85417
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Nitrogen dioxide, Ozone, Reporting and
recordkeeping requirements, Volatile
organic compounds.
Dated: November 7, 2016.
Heather McTeer Toney,
Regional Administrator, Region 4.
40 CFR part 52 is amended as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart RR—Tennessee
2. In § 52.2220, the table in paragraph
(e) is amended by adding the entry
‘‘110(a)(1) and (2) Infrastructure
Requirements for the 2010 1-hour SO2
NAAQS’’ at the end of the table to read
as follows:
■
§ 52.2220
*
Identification of plan.
*
*
(e) * * *
*
*
EPA-APPROVED TENNESSEE NON-REGULATORY PROVISIONS
Applicable geographic or nonattainment area
State effective
date
EPA approval date
Explanation
*
Tennessee .............
*
03/13/2014
*
11/28/16, [insert
Federal Register
citation].
*
*
With the exception of interstate transport
requirements
of
section
110(a)(2)(D)(i)(I) and (II) (prongs 1, 2,
and 4).
Name of non-regulatory SIP provision
*
*
110 (a)(1) and (2) Infrastructure Requirements for the 2010 1-hour SO2
NAAQS.
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 131
[EPA–HQ–OW–2015–0174; FRL–9955–40–
OW]
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RIN 2040–AF56
Revision of Certain Federal Water
Quality Criteria Applicable to
Washington
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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On September 14, 2015, the
Environmental Protection Agency (EPA)
proposed revisions to the federal Clean
Water Act (CWA) human health criteria
applicable to waters under the State of
Washington’s jurisdiction to ensure that
the criteria are set at levels that will
adequately protect Washington
residents, including tribes with treatyreserved rights, from exposure to toxic
pollutants. EPA promulgated
Washington’s previous criteria for the
protection of human health in 1992 as
part of the National Toxics Rule (NTR)
(amended in 1999 for Polychlorinated
Biphenyls (PCBs)), using the Agency’s
recommended criteria values at the
time. EPA derived those previously
applicable criteria using a fish
consumption rate (FCR) of 6.5 grams per
SUMMARY:
[FR Doc. 2016–28429 Filed 11–25–16; 8:45 am]
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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.
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EPA is not finalizing criteria in this final
rule for those state-adopted criteria that
EPA approved, or for certain criteria
that EPA has determined involve
scientific uncertainty, as explained
below.
DATES: This final rule is effective on
December 28, 2016.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OW–2015–0174. All
documents in the docket are listed on
the https://www.regulations.gov Web
site. Although listed in the index, some
information is not publicly available,
e.g., CBI or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available electronically through https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Erica Fleisig, Office of Water, Standards
and Health Protection Division (4305T),
Environmental Protection Agency, 1200
Pennsylvania Avenue NW., Washington,
DC 20460; telephone number: (202)
566–1057; email address: fleisig.erica@
epa.gov.
SUPPLEMENTARY INFORMATION: This final
rule is organized as follows:
I. General Information
A. Does this action apply to me?
B. How did EPA develop this final rule?
II. Background
A. Statutory and Regulatory Background
B. EPA’s CWA 303(c) Action on
Washington’s Human Health Criteria
C. General Recommended Approach for
Deriving Human Health Criteria
III. Derivation of Human Health Criteria for
Washington
A. Scope of Pollutants and Waters Covered
by This Final Rule
B. Washington’s Designated Uses and
Tribal Reserved Fishing Rights
C. Washington-Specific Human Health
Criteria Inputs
D. Final Human Health Criteria for
Washington
E. Applicability of Criteria
F. Alternative Regulatory Approaches and
Implementation Mechanisms
IV. Economic Analysis
A. Identifying Affected Entities
B. Method for Estimating Costs
C. Results
V. Statutory and Executive Order Reviews
A. Executive Order 12866 (Regulatory
Planning and Review) and Executive
Order 13563 (Improving Regulation and
Regulatory Review)
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132 (Federalism)
F. Executive Order 13175 (Consultation
and Coordination With Indian Tribal
Governments)
G. Executive Order 13045 (Protection of
Children From Environmental Health
and Safety Risks)
H. Executive Order 13211 (Actions That
Significantly Affect Energy Supply,
Distribution, or Use)
I. National Technology Transfer and
Advancement Act of 1995
J. Executive Order 12898 (Federal Actions
To Address Environmental Justice in
Minority Populations and Low-Income
Populations)
K. Congressional Review Act (CRA)
I. General Information
A. Does this action apply to me?
Entities such as industries,
stormwater management districts, or
publicly owned treatment works
(POTWs) that discharge pollutants to
waters of the United States under the
State of Washington’s jurisdiction could
be indirectly affected by this
rulemaking, because federal water
quality standards (WQS) promulgated
by EPA are applicable to CWA
regulatory programs, such as National
Pollutant Discharge Elimination System
(NPDES) permitting. Citizens concerned
with water quality in Washington could
also be interested in this rulemaking.
Categories and entities that could
potentially be affected include the
following:
Category
Examples of potentially affected entities
Industry ...........................................
Municipalities ...................................
Industries discharging pollutants to waters of the United States in Washington.
Publicly owned treatment works or other facilities discharging pollutants to waters of the United States in
Washington.
Entities responsible for managing stormwater runoff in the State of Washington.
Stormwater Management Districts ..
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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
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September 14, 2015.1 On October 28,
2015, in response to stakeholder
requests,2 EPA extended the public
comment period for an additional 45
days.3 In addition, EPA held two virtual
public hearings on December 15th and
16th, 2015, to discuss the contents of
the proposed rule and accept verbal
public comments.
Over 60 organizations and individuals
submitted comments on a range of
1 See Revision of Certain Federal Water Quality
Criteria Applicable to Washington: Proposed Rule,
80 FR 55063, September 14, 2015.
2 EPA received requests from the Association of
Washington Business—Washington State’s Chamber
of Commerce, Washington Public Ports Association
(on behalf of the Association of Washington Cities
and the Washington State Association of Counties),
Western Wood Preservers Institute, ALCOA,
American Forest and Paper Association, McFarland
Cascade, Schnitzer Steel Industries, and
Weyerhaeuser.
3 See Extension of Public Comment Period for the
Revision of Certain Federal Water Quality Criteria
Applicable to Washington, 80 FR 65980, October
28, 2015.
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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
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Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations
interprets ‘‘fishable’’ uses to include, at
a minimum, designated uses providing
for the protection of aquatic
communities and human health related
to consumption of fish and shellfish.4
CWA section 303(c) (33 U.S.C.
1313(c)) directs states to adopt WQS for
their waters subject to the CWA. CWA
section 303(c)(2)(A) and EPA’s
implementing regulations at 40 CFR part
131 require, among other things, that a
state’s WQS specify appropriate
designated uses of the waters, and water
quality criteria that protect those uses.
EPA’s regulations at 40 CFR 131.11(a)(1)
provide that ‘‘[s]uch criteria must be
based on sound scientific rationale and
must contain sufficient parameters or
constituents to protect the designated
use. For waters with multiple use
designations, the criteria shall support
the most sensitive use.’’ In addition, 40
CFR 131.10(b) provides that ‘‘[i]n
designating uses of a water body and the
appropriate criteria for those uses, the
state shall take into consideration the
water quality standards of downstream
waters and ensure that its water quality
standards provide for the attainment
and maintenance of the water quality
standards of downstream waters.’’
States are required to review
applicable WQS at least once every
three years and, if appropriate, revise or
adopt new standards (CWA section
303(c)(1)). Any new or revised WQS
must be submitted to EPA for review
and approval or disapproval (CWA
section 303(c)(2)(A) and (c)(3)). If EPA
disapproves a state’s new or revised
WQS, the CWA provides the state 90
days to adopt a revised WQS that meets
CWA requirements, and if it fails to do
so, EPA shall promptly propose and
then within 90 days promulgate such
standard unless EPA approves a state
replacement WQS first (CWA section
303(c)(3) and (c)(4)(A)). CWA section
303(c)(4)(B) authorizes the
Administrator to determine that a new
or revised standard is needed to meet
CWA requirements. Upon making such
a determination, the CWA specifies that
EPA shall promptly propose, and then
within 90 days promulgate, any such
new or revised standard unless prior to
such promulgation, the state has
adopted a revised or new WQS that EPA
determines to be in accordance with the
CWA.
Under CWA section 304(a), EPA
periodically publishes criteria
recommendations for states to consider
when adopting water quality criteria for
4 USEPA. 2000. Memorandum #WQSP–00–03.
U.S. Environmental Protection Agency, Office of
Water, Washington, DC https://www.epa.gov/sites/
production/files/2015-01/documents/standardsshellfish.pdf.
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particular pollutants to protect the CWA
section 101(a)(2) goal uses. In 2015, EPA
updated its 304(a) recommended criteria
for human health for 94 pollutants.5
Where EPA has published
recommended criteria, states should
establish numeric water quality criteria
based on EPA’s CWA section 304(a)
criteria, section 304(a) criteria modified
to reflect site-specific conditions, or
other scientifically defensible methods
(40 CFR 131.11(b)(1)). In all cases
criteria must be sufficient to protect the
designated use and be based on sound
scientific rationale (40 CFR
131.11(a)(1)). CWA section 303(c)(2)(B)
requires states to adopt numeric criteria
for all toxic pollutants listed pursuant to
CWA section 307(a)(1) for which EPA
has published 304(a) criteria, as
necessary to support the states’
designated uses.
In 1992, EPA promulgated the NTR at
40 CFR 131.36, establishing chemicalspecific numeric criteria for 85 priority
toxic pollutants for 14 states and
territories (states), including
Washington, that were not in
compliance with the requirements of
CWA section 303(c)(2)(B). When states
covered by the NTR subsequently
adopted their own criteria for toxic
pollutants that EPA approved as
consistent with the CWA and EPA’s
implementing regulations, EPA
amended the NTR to remove those
criteria for those states.
B. EPA’s CWA 303(c) Action on
Washington’s Human Health Criteria
On September 14, 2015, EPA made a
CWA 303(c)(4)(B) determination that
new or revised WQS for the protection
of human health in Washington were
necessary to meet the requirements of
the CWA, and proposed revised human
health criteria for the state (see 80 FR
55063). At that time, Washington had
not yet adopted its own criteria for the
protection of human health.6 On August
1, 2016, Washington adopted and
submitted statewide human health
criteria and new and revised
implementation provisions. Concurrent
with this final rule, EPA approved 45
and disapproved 143 of Washington’s
human health criteria under CWA
303(c). EPA is finalizing 144 human
health criteria in this rule in accordance
5 Final Updated Ambient Water Quality Criteria
for the Protection of Human Health, (80 FR 36986,
June 29, 2015). See also: USEPA. 2015. Final 2015
Updated National Recommended Human Health
Criteria. U.S. Environmental Protection Agency,
Office of Water, Washington, DC https://
www.epa.gov/wqc/human-health-water-qualitycriteria.
6 Washington adopted criteria for the protection
of aquatic life from toxic pollutants at WAC 173–
201A–240.
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85419
with CWA section 303(c)(3) and (c)(4)
requirements.7 After the effective date of
this final rule, these federal criteria will
be in effect for CWA purposes along
with the human health criteria that
Washington adopted and EPA approved.
Several commenters provided
comments on the timing of EPA’s rule,
and the relationship between EPA’s
federal rulemaking and the state
rulemaking process. These comments
are now, for the most part, mooted by
EPA’s finalization of its federal rule and
action on the state’s submittal. For
additional responses to specific
comments, see EPA’s Response to
Comment document in the docket for
this rule.
C. General Recommended Approach for
Deriving Human Health Criteria
Human health criteria are designed to
minimize the risk of adverse cancer and
non-cancer effects occurring from
lifetime exposure to pollutants through
the ingestion of drinking water and
consumption of fish and shellfish
obtained from inland and nearshore
waters (by nearshore waters, EPA refers
to waters out to three miles from the
coast). EPA’s practice is to establish a
human health 304(a) recommended
criterion for both drinking water and
consumption of fish and shellfish from
inland and nearshore waters combined,
and a separate human health criterion
based only on ingestion of fish and
shellfish from inland and nearshore
waters. This latter criterion applies in
cases where the designated uses of a
waterbody include supporting fish and
shellfish for human consumption but
not drinking water supply sources (e.g.,
in non-potable estuarine waters).
The criteria are based on two types of
biological endpoints: (1) Carcinogenicity
and (2) systemic toxicity (i.e., all
adverse effects other than cancer). EPA
takes an integrated approach and
considers both cancer and non-cancer
effects when deriving human health
criteria. Where sufficient data are
available, EPA derives criteria using
7 EPA is finalizing a different number of human
health criteria (144) than it is disapproving (143) in
Washington’s 2016 submittal. Washington did not
adopt organism-only criteria for methylmercury or
water-plus-organism and organism-only criteria for
bis(2-chloro-1-methylethyl) ether. These are priority
pollutants listed pursuant to CWA section 307(a)(1)
for which EPA has 304(a) recommended criteria,
and, as such, CWA section 303(c)(2)(B) requires that
states adopt numeric criteria for these pollutants, as
necessary to support the states’ designated uses.
Therefore, EPA is including these three criteria in
this final rule for Washington. This final rule,
however, does not include revised water-plusorganism and organism-only criteria for arsenic, as
explained below in section III.A, even though EPA
is disapproving the arsenic criteria in Washington’s
submittal.
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both carcinogenic and non-carcinogenic
toxicity endpoints and recommends the
lower value. Human health criteria for
carcinogenic effects are calculated using
the following input parameters: Cancer
slope factor (CSF), cancer risk level,
body weight, drinking water intake rate,
fish consumption rate, and a
bioaccumulation factor(s). Human
health criteria for non-carcinogenic and
nonlinear carcinogenic effects are
calculated using a reference dose (RfD)
in place of a CSF and cancer risk level,
and a relative source contribution (RSC)
factor, which is intended to ensure that
an individual’s total exposure to a given
pollutant from all sources does not
exceed the RfD. Each of these inputs is
discussed in more detail below and in
EPA’s 2000 Human Health Methodology
(hereafter referred to as EPA’s ‘‘2000
Methodology’’).8
a. Cancer Risk Level
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EPA’s 304(a) national recommended
human health criteria are typically
based on the assumption that
carcinogenicity is a ‘‘non-threshold
phenomenon,’’ which means that there
are no ‘‘no-effect’’ levels, because even
extremely small doses are assumed to
cause a finite increase in the incidence
of cancer. Therefore, EPA calculates
304(a) human health criteria for
carcinogenic effects as pollutant
concentrations corresponding to lifetime
increases in the risk of developing
cancer.9 EPA calculates its 304(a)
human health criteria values at a 10¥6
(one in one million) cancer risk level
and recommends cancer risk levels of
10¥6 or 10¥5 (one in one hundred
thousand) for the general population.10
EPA notes that states and authorized
tribes can also choose a more stringent
risk level, such as 10¥7 (one in ten
million), when deriving human health
criteria.
8 USEPA. 2000. Methodology for Deriving
Ambient Water Quality Criteria for the Protection
of Human Health. U.S. Environmental Protection
Agency, Office of Water, Washington, DC EPA–822–
B–00–004. https://www.epa.gov/wqc/humanhealth-water-quality-criteria.
9 As noted above, EPA recommends the criterion
derived for non-carcinogenic effects if it is more
protective (lower) than that derived for carcinogenic
effects.
10 EPA’s 2000 Methodology also states: ‘‘Criteria
based on a 10¥5 risk level are acceptable for the
general population as long as states and authorized
tribes ensure that the risk to more highly exposed
subgroups (sport fishers or subsistence fishers) does
not exceed the 10¥4 level.’’ Since EPA is
establishing final criteria to protect a target general
population of tribes with reserved subsistence
fishing rights in Washington waters, the applicable
EPA-recommended cancer risk levels would relate
to that target general population, as opposed to the
general population of Washington residents overall.
See section III for additional discussion.
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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-adverseeffect level (LOAEL), or benchmark dose
can be obtained. Uncertainty factors are
applied to reflect the limitations of the
data. EPA’s Integrated Risk Information
System (IRIS) 11 was the primary source
of toxicity values (i.e., RfD and CSF) for
EPA’s 2015 updated 304(a) human
health criteria.12 For some pollutants,
however, more recent peer-reviewed
and publicly available toxicological data
were available from other EPA program
offices (e.g., Office of Pesticide
Programs, Office of Water, Office of
Land and Emergency Management),
other national and international
programs, and state programs.
c. Exposure Assumptions
EPA’s latest 304(a) national human
health criteria use a default drinking
water intake rate of 2.4 liters per day (L/
day) and default rate of 22 g/day for
11 USEPA. Integrated Risk Information System
(IRIS). U.S. Environmental Protection Agency,
Office of Research and Development, Washington,
DC www.epa.gov/iris.
12 Final Updated Ambient Water Quality Criteria
for the Protection of Human Health, (80 FR 36986,
June 29, 2015). See also: USEPA. 2015. Final 2015
Updated National Recommended Human Health
Criteria. U.S. Environmental Protection Agency,
Office of Water, Washington, DC https://
www.epa.gov/wqc/human-health-water-qualitycriteria.
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consumption of fish and shellfish from
inland and nearshore waters, multiplied
by pollutant-specific bioaccumulation
factors (BAFs) to account for the amount
of the pollutant in the edible portions of
the ingested species. EPA’s 2000
Methodology for deriving human health
criteria emphasizes using, when
possible, measured or estimated BAFs,
which account for chemical
accumulation in aquatic organisms from
all potential exposure routes.13 In the
2015 national 304(a) human health
criteria update, EPA primarily used
field-measured BAFs, and laboratorymeasured bioconcentration factors
(BCFs) with applicable food chain
multipliers available from peerreviewed, publicly available databases,
to develop national BAFs for three
trophic levels of fish. If this information
was not available, EPA selected octanolwater partition coefficients (Kow values)
from peer-reviewed sources for use in
calculating national BAFs.14
EPA’s national default drinking water
intake rate of 2.4 L/day represents the
per capita estimate of combined direct
and indirect community water ingestion
at the 90th percentile for adults ages 21
and older.15 EPA’s national default FCR
of 22 g/day represents the 90th
percentile consumption rate of fish and
shellfish from inland and nearshore
waters for the U.S. adult population 21
years of age and older, based on
National Health and Nutrition
Examination Survey (NHANES) data
from 2003 to 2010.16 17 EPA calculates
13 USEPA. 2000. Methodology for Deriving
Ambient Water Quality Criteria for the Protection
of Human Health. U.S. Environmental Protection
Agency, Office of Water, Washington, DC EPA–822–
B–00–004. https://www.epa.gov/wqc/humanhealth-water-quality-criteria.
14 Final Updated Ambient Water Quality Criteria
for the Protection of Human Health, (80 FR 36986,
June 29, 2015). See also: USEPA. 2015. Final 2015
Updated National Recommended Human Health
Criteria. U.S. Environmental Protection Agency,
Office of Water, Washington, DC https://
www.epa.gov/wqc/human-health-water-qualitycriteria.
15 USEPA. 2011. EPA Exposure Factors
Handbook. 2011 edition (EPA 600/R–090/052F).
https://cfpub.epa.gov/ncea/risk/
recordisplay.cfm?deid=236252.
16 USEPA. 2014. Estimated Fish Consumption
Rates for the U.S. Population and Selected
Subpopulations (NHANES 2003–2010). United
States Environmental Protection Agency,
Washington, DC EPA 820–R–14–002.
17 EPA’s national FCR is based on the total rate
of consumption of fish and shellfish from inland
and nearshore waters (including fish and shellfish
from local, commercial, aquaculture, interstate, and
international sources). This is consistent with a
principle that each state does its share to protect
people who consume fish and shellfish that
originate from multiple jurisdictions. USEPA.
January 2013. Human Health Ambient Water
Quality Criteria and Fish Consumption Rates:
Frequently Asked Questions. https://www.epa.gov/
wqc/human-health-ambient-water-quality-criteriaand-fish-consumption-rates-frequently-asked.
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human health criteria using a default
body weight of 80 kilograms (kg), the
average weight of a U.S. adult age 21
and older, based on NHANES data from
1999 to 2006.
Although EPA uses these default
values to calculate national 304(a)
recommended human health criteria,
EPA’s 2000 Methodology notes a
preference for the use of local data to
calculate human health criteria (e.g.,
locally derived FCRs, drinking water
intake rates and body weights, and
waterbody-specific bioaccumulation
rates) over national default values,
where data are sufficient to do so, to
better represent local conditions.18 It is
also important, where sufficient data are
available, to select a FCR that reflects
consumption that is not suppressed by
concerns about the safety of available
fish.19 20 Deriving human health criteria
using an unsuppressed FCR furthers the
restoration goals of the CWA and
ensures protection of human healthrelated designated uses (as pollutant
levels decrease, fish habitats are
restored, and fish availability increases
over time). See section III for additional
discussion regarding use of an
unsuppressed FCR to protect a
subsistence or sustenance fishing use,
especially where the subsistence or
sustenance use is based in whole or in
part on tribal treaty or other reserved
fishing rights.21
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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
18 USEPA. 2000. Methodology for Deriving
Ambient Water Quality Criteria for the Protection
of Human Health. U.S. Environmental Protection
Agency, Office of Water, Washington, DC EPA–822–
B–00–004. https://www.epa.gov/wqc/humanhealth-water-quality-criteria.
19 USEPA. January 2013. Human Health Ambient
Water Quality Criteria and Fish Consumption Rates:
Frequently Asked Questions. https://www.epa.gov/
wqc/human-health-ambient-water-quality-criteriaand-fish-consumption-rates-frequently-asked.
20 National Environmental Justice Advisory
Council, Fish Consumption and Environmental
Justice, p.44 (2002) available at https://
www.epa.gov/sites/production/files/2015-02/
documents/fish-consump-report_1102.pdf.
21 The term ‘‘subsistence’’ is coterminous with
‘‘sustenance’’ in this context. Hereafter, the
document uses the term ‘‘subsistence.’’
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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
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priority toxic pollutants such as arsenic
and dioxin. Given the scientific
uncertainty regarding aspects of the
science upon which the proposed
human health criteria for arsenic,
dioxin, and thallium were based, EPA is
withdrawing its proposal of revised
criteria for these three pollutants at this
time and leaving the existing criteria
from the NTR in effect for CWA
purposes.22 EPA did not update the
304(a) national recommended criteria
for these three pollutants in 2015. As
noted earlier, IRIS was the primary
source of toxicity values (i.e., RfD and
CSF) for EPA’s 2015 updated 304(a)
human health criteria. For thallium,
EPA’s IRIS database does not currently
contain an estimate of thallium’s
toxicity (i.e., a RfD).23 For dioxin, IRIS
does not currently contain a measure of
dioxin’s cancer-causing ability (i.e., a
CSF).24 Without such values, EPA has
concluded that further analysis is
necessary in order to promulgate
scientifically sound revised criteria for
these two pollutants. For arsenic, there
is uncertainty surrounding the
toxicological assessment with respect to
human health effects. EPA’s current
plan for addressing the arsenic issues is
described in the Assessment
Development Plan for the Integrated
Risk Information System (IRIS)
Toxicological Review of Inorganic
Arsenic (EPA/630/R–14/101, November
2015). EPA intends to reevaluate the
existing federal arsenic, dioxin and
thallium human health criteria for
Washington by 2018, with particular
consideration of any relevant toxicity
and bioaccumulation information.
This rule revises the criteria that EPA
promulgated for Washington in the NTR
(with the exception of criteria for
arsenic, dioxin, and thallium, and
criteria that EPA approved in
Washington’s August 1, 2016 submittal),
and establishes new human health
criteria for 8 additional chemicals for
which EPA now has 304(a)
recommended criteria (and for which
EPA did not approve Washington’s
submitted criteria): Selenium, Zinc, 1,2Trans-Dichloroethylene, Acenaphthene,
Butylbenzyl Phthalate, 2Chloronaphthalene, 1,1,1Trichloroethane, and 1,2,4Trichlorobenzene. In 2001, EPA
22 EPA is moving Washington’s existing arsenic,
dioxin and thallium criteria from the NTR into 40
CFR 131.45 to have one comprehensive human
health criteria rule for Washington.
23 https://cfpub.epa.gov/ncea/iris/index.cfm
?fuseaction=iris.showQuickView&substance_
nmbr=1012.
24 https://cfpub.epa.gov/ncea/iris/index.cfm
?fuseaction=iris.showQuickView&substance_
nmbr=1024.
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replaced its 304(a) recommended
human health criteria for total mercury
with a fish tissue-based human health
criterion for methylmercury.25
Washington did not include human
health criteria for mercury or
methylmercury in its August 1, 2016
submittal. Therefore, with this final
rule, EPA replaces the criteria for total
mercury that EPA promulgated for
Washington in the NTR with a
methylmercury fish tissue criterion,
based on EPA’s 2001 304(a)
recommendation but adjusted to
incorporate the 175 g/day FCR that EPA
used to derive revised human health
criteria in Washington, as well as EPA’s
2015 updated national default body
weight of 80 kg.
A few commenters expressed concern
that Washington would not have the
data or implementation guidance to
properly implement a fish tissue
criterion for methylmercury, and
requested that EPA leave the NTR total
mercury criteria in effect in Washington.
The fish tissue methylmercury criterion
reflects EPA’s 2000 Methodology, the
best available science, and supersedes
all previous 304(a) human health
mercury criteria recommendations
published by EPA (except for the waters
of the Great Lakes System), including
the 304(a) recommended criteria that
served as the basis for the total mercury
criteria that EPA promulgated for
Washington in the NTR. EPA
recommends a fish tissue water quality
criterion for methylmercury for many
reasons. A fish tissue water quality
criterion integrates spatial and temporal
complexity that occurs in aquatic
systems and affects methylmercury
bioaccumulation. For this pollutant, a
fish tissue criterion is more closely tied
to the goal of protecting human health
because it is based directly on the
dominant human exposure route for
methylmercury in the U.S., which is
consumption of fish and shellfish. The
concentration of methylmercury is also
generally easier to quantify in fish tissue
than in water and is less variable in fish
and shellfish tissue over the time
periods in which WQS are typically
implemented in water quality-based
controls, such as NPDES permits.
Finally, fish consumption advisories for
mercury are also based on the amount
of methylmercury in fish tissue.26 While
25 USEPA. 2001. Guidance for Implementing the
January 2001 Methylmercury Water Quality
Criterion. U.S. Environmental Protection Agency,
Office of Water, Washington, DC EPA–823–R–01–
001. https://www.epa.gov/wqc/guidanceimplementing-january-2001-methylmercury-waterquality-criterion.
26 While both water quality criteria and fish
consumption advisories are designed ultimately to
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the purpose of a fish advisory is
different from the purpose of a water
quality criterion, it will be helpful to the
public to have water quality criteria and
fish consumption advisories for
methylmercury expressed using the
same terms. In response to comments
regarding implementation of the
methylmercury criterion, in 2010, EPA
published the comprehensive Guidance
for Implementing the January 2001
Methylmercury Water Quality Criterion
(EPA 823–R–10–001), to aid states in
implementing the fish tissue-based
methylmercury water quality criterion.
EPA is confident that Washington will
be able to implement the fish tissue
criterion using the information
contained in that document, and EPA
remains available to offer assistance in
doing so. Thus there is no need or
requirement to leave the NTR total
mercury criteria in place in Washington.
This final rule does not change or
supersede any criteria that EPA
previously promulgated for other states
in the NTR, nor does it change any other
elements of the NTR such as EPA’s
original basis for promulgation. For
clarity in organization, EPA is
withdrawing Washington from the NTR
at 40 CFR 131.36 and incorporating the
Washington-specific criteria in this rule
(as well as the existing NTR criteria for
arsenic, dioxin and thallium) into 40
CFR 131.45 so there is a single
comprehensive set of federally
promulgated criteria for Washington.
This rule applies to waters under the
State of Washington’s jurisdiction, and
not to waters within Indian country,27
unless otherwise specified in federal
law. Some waters located within Indian
country already have CWA-effective
human health criteria, while others do
not.28 Several tribes are working with
EPA to either revise their existing CWAeffective WQS, or obtain treatment in a
similar manner as a state (TAS) status in
order to adopt CWA-effective WQS in
the near future. EPA will continue to
work closely with tribes in Washington
to ensure that they adopt human health
protect human health, they represent very different
values and goals. Water quality criteria express or
establish a desired condition and must protect the
designated use, such as subsistence fishing. Fish
consumption advisories start with existing levels of
fish contamination resulting from impaired water
quality, and provide advice to populations
consuming such fish on limiting levels of
consumption in order to reduce risk from
contamination.
27 See 18 U.S.C. 1151 for the definition of Indian
country.
28 Indian country waters with CWA-effective
WQS include those where (a) EPA has authorized
a tribe to adopt WQS under the CWA for its
reservation and the tribe has adopted standards that
EPA has approved, and (b) EPA has promulgated
federal WQS.
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criteria that are scientifically supported
and protective of designated uses, in
accordance with the CWA and EPA’s
regulations. In addition, on September
29, 2016, EPA published an Advanced
Notice of Proposed Rulemaking in the
Federal Register that seeks input on an
approach that involves EPA
promulgating baseline WQS for
reservations that currently have no
CWA-effective WQS, including such
reservations within the State of
Washington.29
B. Washington’s Designated Uses and
Tribal Reserved Fishing Rights
a. EPA’s Consideration of Tribal Treaty
Rights
Under the Supremacy Clause of the
U.S. Constitution, federal treaties have
the same legal force as federal statutes.30
As such, the provisions of federal
statutes should generally be read in
harmony with treaties where they both
apply. In certain instances, statutes may
contain provisions indicating that they
must be read in harmony with treaties.
Such is the case with the CWA, which
provides that the Act ‘‘shall not be
construed as . . . affecting or impairing
the provisions of any treaty of the
United States.’’ 31
In determining whether WQS satisfy
the CWA and EPA’s regulations, and
when setting criteria for the protection
of human health, it is necessary to
consider other applicable laws, such as
federal treaties (e.g., U.S. Treaties with
Indians). While treaties do not expand
EPA’s authority, they are binding on the
federal government. As a result, EPA
has an obligation to ensure that its
actions do not conflict with tribal treaty
rights.32 For the foregoing reasons, and
29 For more information, see: https://
www.epa.gov/wqs-tech/advance-notice-proposedrulemaking-federal-baseline-water-qualitystandards-indian.
30 U.S. Const. art. IV, § 2: The ‘‘Constitution . . .
of the United States . . . and all Treaties made, or
which shall be made, under the Authority of the
United States, shall be the supreme Law of the
Land; and the Judges in every State shall be bound
thereby, any Thing in the Constitution or Laws of
any State to the Contrary notwithstanding.’’
31 CWA Section 511, 33 U.S.C. 1371.
32 U.S. Const. art. IV, § 2; see United States v.
Forty-Three Gallons of Whiskey, 93 U.S. 188, 196
(1833) (recognizing that ‘‘the Constitution declares
a treaty to be the supreme law of the land,’’ and that
‘‘a treaty is to be regarded . . . as equivalent to an
act of the legislature’’) and Worcester v. Georgia, 31
U.S. 515, 594 (1832) (‘‘So long as . . . treaties exist,
having been formed within the sphere of the federal
powers, they must be respected and enforced by the
appropriate organs of the federal government.’’). See
also EPA policies on considering treaty rights:
Working Effectively With Tribal Governments:
Resource Guide at pp. 49–52, 53 (August 1998)
(explaining the key principles underlying the
application of Indian treaty rights, and noting that
‘‘[f]ederal, state, and local agencies need to refrain
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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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b. Treaty-Reserved Subsistence Fishing
Rights in Washington
The majority of waters under the
jurisdiction of the State of Washington
are subject to federal treaties with
tribes.33 There are eight Stevens-Palmer
Treaties relevant to the State of
Washington through which 24 tribes
reserved for themselves identical or
nearly identical fishing rights within the
boundaries of present-day Washington;
specifically, the treaty-reserved ‘‘right of
taking fish at usual and accustomed
places, in common with all citizens of
the Territory.’’ 34 The right to take fish
at usual and accustomed places extends
to lands formerly ceded by the tribes to
the U.S. as described in the treaties, as
well as to all places beyond the
boundaries of the ceded territories that
tribal members regularly used at treaty
time.35
The parties to the treaties all
recognized the importance of the fishing
right for the tribes’ subsistence,
ceremonial, as well as commercial
from taking actions that are not consistent with
tribal rights wherever they exist’’); Commemorating
the 30th Anniversary of the EPA’s Indian Policy,
Memorandum from Gina McCarthy to All EPA
Employees, p. 1 (December 1, 2014) (reiterating that
‘‘EPA must ensure that its actions do not conflict
with tribal treaty rights’’ and stating that ‘‘EPA
programs should be implemented to enhance the
protection of tribal treaty rights and treaty-covered
resources when we have the discretion to do so’’);
EPA Policy for the Administration of Environmental
Programs on Indian Reservations (November 8,
1984) (known as ‘‘EPA 1984 Indian Policy’’).
33 See https://wdfw.wa.gov/hunting/tribal/treaty_
history.html.
34 See e.g. Treaty with the Yakima art. 3, June 9,
1855, 12 Stat. 951. In United States v. Winans, 198
U.S. 371 (1905), the Supreme Court adopted a
‘‘reservation of rights’’ approach in interpreting the
Stevens Treaty with the Yakima Nation: ‘‘the treaty
was not a grant of rights to the Indians, but a grant
of rights from them—a reservation of those not
granted.’’ Id. at 381. In contrast, ‘‘off reservation
fishing by other citizens and residents of the state
is not a right but merely a privilege which may be
granted, limited or withdrawn by the state as the
interests of the state or the exercise of treaty fishing
rights may require.’’ U.S. v Washington, 384 F.
Supp. 312, 332 (W.D. Wash. 1974) aff’d 520 F.2d
676 (9th Cir. 1975), cert. denied 423 U.S. 1086
(1976).
35 See Seufert Bros. Co. v. U.S., 249 U.S. 194, 199
(1919). In U.S. v Washington, the court stated, citing
Seufert Bros. Co., ‘‘every fishing location where
members of a tribe customarily fished from time to
time at and before treaty times, however distant
from the then usual habitat of the tribe, and
whether or not other tribes then also fished in the
same waters, is a usual and accustomed ground or
station at which the treaty tribe reserved, and its
members presently have, the right to take fish.’’ 384
F. Supp. at 332.
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purposes.36 In U.S. v Washington, the
district court made detailed findings of
facts regarding the reserved fishing
right, including the importance of
subsistence fishing to the treaty tribes:
At the treaty negotiations, a primary
concern of the tribes, whose way of life was
so heavily dependent upon harvesting
anadromous fish, was that they have freedom
to move about to gather food, particularly
salmon, . . . at their usual and accustomed
fishing places. . . . Subsequent to the
execution of the treaties and in reliance
thereon, the members of the [treaty tribes
with reserved fishing rights in Washington]
have continued to fish for subsistence, sport,
and commercial purposes at their usual and
accustomed places. Such fishing provided
and still provides an important part of their
livelihood, subsistence and cultural identity.
The Indian cultural identification with
fishing is primarily dietary, related to the
subsistence fishery, and secondarily
associated with religious ceremonies and
commercial fishing.37
Relevant case law, including Supreme
Court precedents, unequivocally
confirms that the treaty-reserved right to
take fish includes the right to take fish
for subsistence purposes.38 Historical
and current evidence of tribal members’
36 For a thorough discussion on the treaty
negotiation and execution and meaning of the
reserved fishing right, see e.g., U.S. v Washington,
384 F. Supp. at 348–359 (containing finding of facts
regarding, inter alia, treaty status, pre-treaty role of
fishing among northwest Indians, treaty
background, negotiation and execution of the
treaties, and post-treaty Indian fishing); see also id.
at 340 (‘‘The right to fish for all species available
in the waters from which, for so many ages, their
ancestors derived most of their subsistence is the
single most highly cherished interest and concern
of the present members of plaintiff tribes, with rare
exceptions even among tribal members who
personally do not fish or derive therefrom any
substantial amount of their subsistence.’’); id. at 343
(‘‘The evidence shows beyond doubt that at treaty
time the opportunity to take fish for personal
subsistence and religious ceremonies was the single
matter of utmost concern to all treaty tribes and
their members.’’); and U.S. v. Washington, No. 13–
35474, 2016 U.S. App. LEXIS 11709, at *29 (9th Cir.
June 27, 2016) (‘‘The Indians reasonably understood
Governor Stevens to promise not only that they
would have access to their usual and accustomed
fishing places, but also that there would be fish
sufficient to sustain them.’’).
37 U.S. v Washington, 384 F. Supp. at 355–358
(internal citations to exhibits omitted).
38 See e.g., Washington v. Washington State
Commercial Passenger Fishing Vessel Ass’n, 443
U.S. 658, 678–679 (1979) (Because the Indians had
always exercised the right to meet their subsistence
and commercial needs by taking fish from treaty
area waters, they would be unlikely to perceive a
‘‘reservation’’ of that right as merely the chance,
shared with millions of other citizens, occasionally
to dip their nets into the territorial waters.
Moreover, the phrasing of the clause quite clearly
avoids placing each individual Indian on an equal
footing with each individual citizen of the State.’’);
U.S. v. Washington, 2016 U.S. App. LEXIS 11709
at *28 (Observing that to the Tribes, the Stevens
Treaties’ ‘‘principal purpose was to secure a means
of supporting themselves once the Treaties took
effect,’’ and to that end, ‘‘[s]almon were a central
concern.’’).
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exercise of the treaty-reserved
subsistence fishing right can be found in
heritage FCR reports and contemporary
FCR surveys (for tables of relevant FCRs,
see EPA’s Response to Comment
document in the docket for this rule).
As explained above, the StevensPalmer Treaties provide tribes the right
to exercise subsistence fishing practices
on waters throughout the State of
Washington. EPA concludes that the
purpose for which tribes reserved such
fishing rights through treaties with the
U.S. has important implications for
water quality regulation under the
CWA. Fundamentally, the tribes’ ability
to take fish for their subsistence
purposes under the treaties would be
substantially affected or impaired if it
were not supported by water quality
sufficient under the CWA to ensure that
tribal members can safely eat the fish for
their own subsistence.
Many areas where treaty-reserved
fishing rights are exercised cannot be
directly protected or regulated by tribal
governments to ensure adequate water
quality, and therefore the responsibility
falls to the federal government (and the
states) to ensure their protection. It is
therefore appropriate and necessary for
EPA (and states) to consider the tribal
reserved rights within the framework of
the CWA, to ensure water quality
protection for treaty-reserved
subsistence fishing rights. EPA’s
consideration of treaty-reserved fishing
rights within the framework of the CWA
leads to the conclusion, as described
below, that the human health fishing
uses for waters in Washington include
subsistence fishing, as informed by the
tribes’ legally protected right to
continue to take fish for subsistence
purposes.39
39 While EPA’s action is based on harmonizing
the requirements of the CWA with the terms of the
treaty-reserved subsistence fishing right, the action
also is consistent with federal Indian law principles
addressing subsidiary treaty rights. A written legal
opinion from the Solicitor of the U.S. Department
of Interior (DOI) to EPA analyzed whether tribal
reserved fishing rights include subsidiary rights to
sufficient water quality. Letter from Hilary C.
Tompkins, Solicitor, DOI, to Avi Garbow, General
Counsel, EPA, regarding Maine’s WQS and Tribal
Fishing Rights of Maine Tribes (January 30, 2015).
Although DOI’s legal opinion primarily involved an
analysis of fishing rights of tribes in Maine in
connection with EPA’s February 2, 2015 decision to
disapprove WQS applied to waters of Indian Lands
in Maine, its discussion of tribal fishing rights and
water quality has relevance to tribes with reserved
fishing rights in Washington. DOI’s legal opinion
identified several court decisions, including
Supreme Court decisions interpreting the reserved
fishing right in the Stevens Treaties, which have
held that fishing rights for tribes encompass
subsidiary rights that are necessary to render those
rights meaningful. In Washington v. Wash. State
Commercial Passenger Fishing Vessel Ass’n, the
United States Supreme Court held that tribes with
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c. Use(s) of the Water(s) in Question
Consistent with EPA’s September 14,
2015 proposed rule for Washington, in
order to effectuate and harmonize
treaty-reserved fishing rights with the
CWA, EPA has determined that such
rights must be appropriately considered
when determining which criteria are
sufficient to adequately protect
Washington’s designated uses. Looking
at the treaty-reserved subsistence fishing
right within the CWA water quality
framework, the first step is to examine
the use of the water(s) in question. The
CWA generally assigns to a state the
responsibility of determining the
designated uses of its waters (subject to
certain restrictions at 40 CFR 131.10),40
and in Washington the state’s
designated uses include fish and
shellfish harvesting.41 As explained
above, through treaties, tribes reserved
specific fishing rights in Washington’s
waters, including the right to take fish
from such waters for their subsistence.
In order to effectuate these rights in
harmony with the CWA, EPA has
interpreted the state’s EPA-approved
designated fish and shellfish harvesting
use to include or encompass a
reserved fishing rights are entitled to something
more tangible than ‘‘merely the chance . . .
occasionally to dip their nets into the territorial
seas.’’ 443 U.S. 658, 679 (1979). Consistent with this
reasoning, courts have held that treaty-reserved
fishing rights entail the right to access fishing
grounds and the right to water quantity sufficient
to support fish habitat. See e.g., United States v.
Winans, 198 U.S. 371, 384 (1905) (tribe must be
allowed to cross private property to access
traditional fishing ground); Seufert Bros. Co. v.
United States, 249 U.S. 194 (1919) (tribe entitled to
cross over and temporarily use any sites which they
were accustomed to using at treaty time, including
sites outside their ceded territories); United States
v. Adair, 723 F .2d 1394, 1409–10 (9th Cir. 1983)
(holding that the tribe’s fishing right implicitly
reserved sufficient waters to ‘‘secure to the Tribe a
continuation of its traditional . . . fishing lifestyle’’;
Colville Confederated Tribes v. Walton, 647 F.2d 42,
47–48 (9th Cir. 1981) (implying reservation of water
to preserve tribe’s replacement fishing grounds).
Consistent with these precedents, in June 2016 the
U.S. Court of Appeals for the Ninth Circuit affirmed
the district court’s finding that barrier culverts
constructed by the State of Washington obstructing
fish passage were in violation of tribal fishing rights
set forth in the Stevens Treaties, noting that ‘‘the
Tribes’ right of access to their usual and
accustomed fishing places would be worthless
without harvestable fish.’’ United States v.
Washington, 2016 U.S. App. LEXIS 11709 at *31.
The court also acknowledged that the fishing clause
of the Stevens Treaties could give rise to other
environmental obligations, but that those would
need to be addressed on a case-by-case basis
depending on the precise nature of the action. Id.
at *18–19. Consistent with this body of case law,
DOI’s legal opinion concludes that ‘‘fundamental,
longstanding tenets of federal Indian law support
the interpretation of tribal fishing rights to include
the right to sufficient water quality to effectuate the
fishing right.’’ DOI Letter at 10.
40 33 U.S.C. 1251(a)(2), 1313(c)(2)(A).
41 See WAC 173–201A–600 and WAC 173–201A–
610.
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subsistence fishing component based
on, and consistent with, the rights
reserved to the tribes through the
treaties. As discussed in more detail
below, EPA construes the CWA to
require that, when establishing WQS for
these waters, the tribal members must
be considered the target general
population for the purposes of setting
risk levels to protect the subsistence
fishing use.
d. Target General Population for
Deriving Criteria Protective of the Use(s)
Developing criteria to protect the fish
and shellfish harvesting use, which
includes subsistence fishing as informed
by reserved fishing rights, necessarily
involves identifying tribal members
with reserved fishing rights as the target
population for protection. EPA’s
conclusion to identify tribes as the
target population is based on EPA’s
CWA implementing regulations
requiring criteria to support the most
sensitive use (i.e., subsistence fishing)
and EPA’s 2000 Methodology
recommendation that priority be given
to identifying and protecting highly
exposed populations. Further, in order
to derive water quality criteria sufficient
under the CWA to ensure that the tribes’
treaty-reserved right to take fish for
subsistence purposes is not
substantially affected or impaired, it is
reasonable and appropriate to identify
tribes as the target general population
for protection, rather than a
subpopulation, and apply the 2000
Methodology’s recommendations on
exposure for the general population to
the tribal target population.
Per EPA’s regulations at 40 CFR
131.11(a)(1), water quality criteria must
contain sufficient parameters or
constituents to protect the designated
use, and for waters with multiple uses,
the criteria must support the most
sensitive use. In the case of
Washington’s human health-related
uses, the most sensitive use is fish and
shellfish harvesting, which, as
explained above, EPA has interpreted to
include or encompass a subsistence
fishing component based on, and
consistent with, the rights reserved to
the tribes through the treaties.
Developing water quality criteria to
protect the subsistence fishing
component of the fish or shellfish
harvesting use necessarily involves
identifying the population exercising
that use.
EPA’s decision to identify tribes as
the target population is further
supported by EPA guidance for
developing water quality criteria to
protect human health. As explained in
EPA’s 2000 Methodology, the choice of
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the particular population to protect is an
important decision to make when
setting human health criteria.42 EPA
recommends that states provide
adequate protection from adverse health
effects to the general population, as well
as to highly exposed populations, such
as recreational and subsistence fishers,
two distinct groups with FCRs that may
be greater than the general population.43
In fact, EPA’s 2000 Methodology
recommends considering how to protect
both susceptible and highly exposed
populations when setting criteria:
EPA recommends that priority be given to
identifying and adequately protecting the
most highly exposed population. Thus, if the
State or Tribe determines that a highly
exposed population is at greater risk and
would not be adequately protected by criteria
based on the general population, and by the
national 304(a) criteria in particular, EPA
recommends that the State or Tribe adopt
more stringent criteria using alternative
exposure assumptions.44
Therefore, consistent with the guidance,
EPA identifies the tribal population as
the target population for protection and
the subsistence fishing use must be the
focus of the risk assessment supporting
water quality criteria to adequately
protect that use. Deriving criteria
protective of the tribal target population
necessarily involves determining the
appropriate inputs for calculating
protective criteria for tribal subsistence
fishers, such as the FCR and cancer risk
level.
EPA’s approach in the 2000
Methodology, and its approach used for
deriving national 304(a) recommended
criteria, is for human health water
quality criteria to provide a high level
of protection for the general population
(for example, FCRs designed to
represent ‘‘the general population of fish
consumers,’’ or a cancer risk level that
‘‘reflects an appropriate risk for the
general population’’), while recognizing
that more highly exposed
‘‘subpopulations’’ may face greater
levels of risk.45 The 2000 Methodology
does not, however, speak to or envision
the unique situation of setting WQS that
cover areas where tribes have treatyreserved rights to practice subsistence
42 EPA’s
2000 Methodology, 2–1.
at 2–2.
44 EPA’s 2000 Methodology, 2–1—2. See also
EPA’s 2000 Methodology, 4–17 (‘‘When choosing
exposure factor values to include in the derivation
of a criterion for a given pollutant, EPA
recommends considering values that are relevant to
population(s) that is (are) most susceptible to that
pollutant. In addition, highly exposed populations
should be considered when setting criteria.’’).
45 See EPA’s 2000 Methodology, 2–6—7, 4–24—
25.
43 Id.
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fishing.46 Nevertheless, it is possible to
apply the general principles outlined in
the 2000 Methodology to this situation,
as informed by the treaties.
In light of the presence of the treatyreserved fishing rights in Washington,
interpreted by the U.S. Supreme Court
to encompass, among other things,
subsistence fishing, and EPA’s
interpretation of Washington’s fish and
shellfish harvesting use to include
subsistence fishing, it is reasonable and
appropriate to require that tribes with
such rights be considered as the target
general population for deriving criteria
protective of the use rather than a
sensitive subpopulation within the
overall population of Washington.
Treating tribes as the target general
population will help derive water
quality criteria sufficient under the
CWA to ensure that the tribes’ treatyreserved right to take fish for
subsistence purposes is not
substantially affected or impaired.
Therefore, the 2000 Methodology’s
recommendations on exposure for the
target general population can be applied
accordingly. EPA’s conclusion to treat
tribes as the target general population,
as opposed to a subpopulation, is
further supported by relevant case law
interpreting the treaty-reserved fishing
rights applicable in Washington;
specifically the phrase ‘‘in common
with all citizens of the territory.’’
Treating tribes as the target
population instead of a sensitive
subpopulation also impacts another
important input parameter used to
derive human health criteria, the cancer
risk level. For carcinogenic pollutants,
EPA’s 2000 Methodology recommends
that states protect the general
population to a level of incremental
cancer risk no greater than one in one
hundred thousand to one in one million
(1 × 10¥5 to 10¥6). For over 20 years,
Washington has used 10¥6 as the level
of risk that must be used to establish
human health criteria for carcinogenic
pollutants. EPA’s 2000 Methodology
indicates that if there are highly
exposed groups or subpopulations
within that target general population,
such as subsistence consumers, WQS
should protect those consumers to a
46 In response to comments on EPA’s 1998 draft
Human Health Methodology revisions, the Agency
responded: ‘‘As stated in the 1998 draft
Methodology revisions, ‘risk levels and criteria
need to be protective of tribal rights under federal
law (e.g., fishing, hunting, or gathering rights) that
are related to water quality.’ We believe the best
way to ensure that Tribal treaty and other rights
under Federal law are met, consistent with the
Federal trust responsibility, is to address these
issues at the time EPA reviews water quality
standards submissions.’’ (See 65 FR 66444, 66457
November 3, 2000).
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level of incremental risk no greater than
one in ten thousand (1 × 10¥4).47
However, where treaty-reserved tribal
fishing rights apply to particular waters,
it would be unreasonable to expose the
communities exercising those rights to
levels of risk above what would be
reasonable for the general population of
the state. See section III.C.b for more
information on cancer risk level.
e. Water Quality Criteria Sufficient To
Protect the Use(s)
The data used to determine the FCR
are critical to deriving criteria that will
protect the subsistence fishing portion
of the fish and shellfish harvesting
designated use. EPA provides a
recommended national default FCR for
the general population but strongly
recommends the use of local or regional
data, where available, over default
values.48 Further, as EPA explained in
its January 2013 Human Health
Ambient Water Quality Criteria and
Fish Consumption Rates: Frequently
Asked Questions, it is important to
avoid selecting a FCR that reflects
consumption that is suppressed due to
concerns about the safety of available
fish. Under certain circumstances, it
may also be relevant to look at the
availability of fish when considering
suppression effects on current FCRs.49
EPA maintains that it is important, as a
CWA goal, to avoid the suppression
effect that may occur when criteria are
derived using a FCR for a given target
population that reflects an artificially
diminished level of fish consumption
from an appropriate baseline level of
consumption for that population.50 To
47 2000
Methodology, 2–6.
2000 Methodology, 4–24—4–25 (‘‘EPA’s
first preference is that States and authorized Tribes
use the results from fish intake surveys of local
watersheds within the State or Tribal jurisdiction to
establish fish intake rates that are representative of
the defined populations being addressed for the
particular waterbody.’’)
49 As noted by the National Environmental Justice
Advisory Council in the 2002 publication Fish
Consumption and Environmental Justice, ‘‘a
suppression effect may arise when fish upon which
humans rely are no longer available in historical
quantities (and kinds), such that humans are unable
to catch and consume as much fish as they had or
would. Such depleted fisheries may result from a
variety of affronts, including an aquatic
environment that is contaminated, altered (due,
among other things, to the presence of dams),
overdrawn, and/or overfished. Were the fish not
depleted, these people would consume fish at more
robust baseline levels. . . . In the Pacific
Northwest, for example, compromised aquatic
ecosystems mean that fish are no longer available
for tribal members to take, as they are entitled to
do in exercise of their treaty rights.’’). National
Environmental Justice Advisory Council, Fish
Consumption and Environmental Justice, p.44, 46
(2002) available at https://www.epa.gov/sites/
production/files/2015–02/documents/fishconsump-report_1102.pdf.
50 See id. at 43.
48 EPA’s
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85425
use a FCR that is suppressed would not
result in criteria that actually protect a
fishing use because it would merely
reinforce the existing suppressed use, or
worse, set in motion a ‘‘downward
spiral’’ 51 of further reduction/
suppression of fish consumption due to
concerns about the safety of available
fish or depleted fisheries. The CWA is
meant not merely to maintain the status
quo, but to restore and maintain the
chemical, physical, and biological
integrity of the Nation’s waters.
Therefore, deriving criteria using an
unsuppressed FCR furthers the
restoration goals of the CWA and
ensures protection of human healthrelated designated uses (as pollutant
levels decrease, fish habitats are
restored, and fish availability increases
over time).
CWA section 303(c)(2)(A) requires
that water quality criteria be ‘‘based
upon’’ applicable designated uses, and
that such uses and criteria ‘‘shall be
such as to protect the public health or
welfare, enhance the quality of water
and serve the purposes of this [Act].’’
The ‘‘purposes of this [Act]’’ are in
section 101, and include, among other
things, ‘‘to restore and maintain the
chemical, physical, and biological
integrity of the Nation’s waters’’ and
‘‘water quality which provides for the
protection and propagation of fish,
shellfish, and wildlife and provides for
recreation in and on the water.’’ EPA’s
implementing water quality regulations
at 40 CFR 131.11 require water quality
criteria to be based on sound scientific
rationale and sufficient to protect the
designated use, regardless of whether
that use is currently being met. A
subsistence fishing designated use, by
definition, represents a level of fish
consumption that is adequate to provide
subsistence, regardless of whether such
consumption is occurring today. It is
entirely consistent with the CWA and
regulations for EPA to determine that to
protect the designated use, it is
necessary and appropriate to derive the
human health criteria using a fish
consumption rate that reflects a
subsistence level of consumption that is
not artificially suppressed as a result of
concerns about pollution or fish
contamination where such data are
available.
Any fish consumption rate used in
setting criteria to protect a subsistence
fishing use must allow for the
consumption of fish from local waters at
levels that could sustain and be
protective of members of the target
population practicing a subsistence
lifestyle. Water quality criteria derived
51 See
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using a FCR below a level that would be
adequate to sustain members of the
target population exercising a
subsistence use, such as tribal members
who have a history of subsistence
fishing in Washington, would not be
protective of that use. In this context,
use of an unsuppressed rate, where data
to determine that rate are available,
would ensure that the resulting criteria
are protective of the subsistence use.
The importance of relying on an
unsuppressed FCR, where data are
available, is especially evident where
the subsistence use is based in whole or
in part on tribal treaty and other
reserved subsistence fishing rights. This
is because if human health criteria are
set at a level that assumes only
suppressed fish consumption, the
waters will only be protected to support
that level of suppressed fish
consumption and thus never fully
support—and potentially even may
directly impair—the tribes’ legal right to
take fish for subsistence purposes.
Accordingly, where adequate data are
available to clearly demonstrate what
the current unsuppressed FCR is for the
relevant target population, the selected
FCR must reflect that value. In the
absence of such data, states, tribes, and
EPA could consider upper percentile
FCRs of local contemporary fish
consumption surveys (such as the 95th
or 99th percentile), heritage FCR data
for the target population, and/or FCRs
that provide for a subsistence fishing
lifestyle. Consultation with tribes is
important to ensure that all data and
information relevant to this issue are
considered.
Although treaties do not cover all
waters in Washington, they cover the
vast majority of the state’s waters.
Additionally, where treaty and nontreaty reserved rights apply on waters
downstream of waters without reserved
fishing rights, upstream WQS must
provide for the attainment and
maintenance of downstream WQS in
accordance with EPA’s regulations at 40
CFR 131.10(b). Based on a GIS analysis
included in the docket for this final
rulemaking, EPA concluded that greater
than 90 percent of waters in Washington
are covered by treaty rights and/or are
upstream of waters with such rights or
waters in Oregon (see section III.C.a).
For any remaining waters in
Washington, where reserved rights do
not apply and that are not upstream of
waters with such rights or waters in
Oregon, it would be administratively
burdensome to develop separate criteria
to apply to such a small subset of
waters, and would be difficult to
implement separate criteria with a
patchwork of protection among these
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areas when administering the WQS,
NPDES permitting, and other programs.
Therefore, EPA applies these final
criteria to all waters under Washington’s
jurisdiction.
Many commenters supported EPA’s
decisions to derive criteria protective of
the tribal population exercising their
treaty-reserved fishing rights in
Washington as the target general
population, and to apply the resulting
criteria to all waters under Washington’s
jurisdiction. Many other commenters
did not support these decisions, and
argued that EPA did not have a
scientific or legal basis to interpret
Washington’s designated uses to
encompass subsistence fishing and to
treat the tribal population with treatyreserved fishing rights as the target
general population for protection under
such use. For additional responses to
these comments, see EPA’s Response to
Comment document in the docket for
this rule.
C. Washington-Specific Human Health
Criteria Inputs
a. Fish Consumption Rate
In Washington there are 24 tribes with
treaty-reserved fishing rights, rights that
encompass the right to fish for
subsistence purposes, and several local
and regional FCR surveys and heritage
tribal consumption reports with widely
varying estimates of tribal FCRs in
Washington (for tables of relevant FCRs,
see EPA’s Response to Comment
document in the docket for this rule).
Available heritage FCRs range from 401
to 995 g/day, and contemporary survey
FCRs range from 63 to 214 g/day (mean
FCRs) and from 113 to 489 g/day (90th
percentile FCRs). The discrepancy
between contemporary and heritage
FCRs suggests that current FCRs for
certain tribal consumers in Washington
may be suppressed.52 53 It is currently
unclear how a contemporary fish
consumption survey might
quantitatively account for suppression,
resulting in estimates of current FCRs
that are unsuppressed to the maximum
degree practicable. There is no local
survey of contemporary fish
consumption in Washington adjusted
specifically to account for suppression,
and no survey is a clear representation
of current unsuppressed consumption
52 The number of fish advisories and closures due
to contamination also suggest that contemporary
FCRs may be suppressed due to concerns about
pollution. See Washington Department of Health,
Fish Consumption Advisories, available at https://
www.doh.wa.gov/CommunityandEnvironment/
Food/Fish/Advisories.
53 Heritage rates refer to the rates of fish intake
consistent with traditional tribal practices, prior to
contact with European settlers.
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for all tribes in Washington. Consistent
with the principles outlined above, EPA
considered the available, scientifically
sound fish consumption data for
Washington tribes and consulted with
tribal governments to select a FCR for
this final rulemaking.
The Washington tribes have generally
agreed that 175 g/day is acceptable for
deriving protective criteria at this time,
when accompanied by other protective
input parameters to calculate the
criteria. However, EPA recognizes that
some tribes have raised concerns as to
whether a FCR of 175 g/day reasonably
reflects current unsuppressed
consumption rates of tribes within the
State of Washington, based on the best
currently available information. A FCR
of 175 g/day approximates the 95th
percentile consumption rate of surveyed
tribal members from the CRITFC
study 54 and includes anadromous fish,
which is reasonable given that these
marine species reside in Washington’s
nearshore (i.e., within three miles of the
coast) waters, especially Puget Sound,
and accumulate pollutants discharged to
these waters during a significant portion
of their lives. The CRITFC survey also
includes four tribes (three of which have
treaty-reserved rights in Washington,
the most of any one contemporary FCR
survey in Washington) along the
Columbia River in Washington, Idaho,
and Oregon. Given this, and also
considering the variability in heritage
and contemporary FCRs and the
uncertainty regarding suppression
effects on current FCRs, the CRITFC
survey provides scientifically sound
estimates of fish consumption for the
purpose of deriving a Washington
statewide FCR for the tribal target
general population.
Additionally, Oregon, much of which
is downstream from Washington (or
cross-stream in the Columbia River
where it forms the border between the
two states), used a FCR of 175 g/day to
derive statewide human health criteria,
which EPA approved in 2011. Use of
this FCR to derive Washington’s criteria
will thus help ensure the attainment
and maintenance of downstream WQS
in Oregon.
Many commenters supported EPA’s
selected FCR, as well as the Agency’s
position that it is important to consider
suppression effects on the FCR in
general, and necessary and appropriate
to do so where subsistence fishing is a
reserved right and encompassed by the
designated use of the waters. Some
54 Fish Consumption Survey of the Umatilla, Nez
Perce, Yakama, and Warm Springs Tribes of the
Columbia River Basin (Columbia River Inter-Tribal
Fish Commission (CRITFC), 1994).
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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.
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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
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population.55 In this action, as
described above, tribes with treatyreserved rights in Washington are the
target general population for the
purpose of deriving revised criteria to
protect the subsistence fishing uses of
Washington’s waters. Because those
tribes are the general population in this
case, EPA’s selection of a 10¥6 cancer
risk level for the tribal target general
population is consistent with current
EPA guidance, specifically the 2000
Methodology.
In addition, use of a cancer risk rate
of 10¥6 ensures that the resulting
human health criteria for carcinogens
protect the subsistence fishing
component of the designated use. Due to
uncertainty regarding suppression
effects (see sections II.C, III.B, and
III.C.a, and EPA’s Response to Comment
document in the docket for this rule),
using a cancer risk level of 10¥6 along
with a FCR of 175 g/day ensures that
tribal members with treaty-reserved
fishing rights will be protected at an
acceptable risk level for the target
general population. Throughout tribal
consultation, the tribes generally
supported 175 g/day as an acceptable
FCR for purposes of revising
Washington’s human health criteria at
this time, when accompanied by other
protective input parameters (e.g., a
cancer risk level of 10¥6), to account for
the uncertainty around an appropriate
FCR value reflective of tribal
subsistence fishing.
Finally, as discussed in section III.C.a,
many of Washington’s rivers are in the
Columbia River Basin, upstream of
Oregon’s portion of the Columbia River.
Oregon’s criteria are based on a FCR of
175 g/day and a cancer risk level of
10¥6. EPA’s decision to derive human
health criteria for Washington using a
cancer risk level of 10¥6 along with a
FCR of 175 g/day helps ensure that
Washington’s criteria will ensure the
attainment and maintenance of Oregon’s
downstream WQS as required by 40
CFR 131.10(b).
Many commenters supported EPA’s
selection of a 10¥6 cancer risk level, and
EPA’s rationale for doing so. Many other
commenters disagreed and argued that
deriving human health criteria for
Washington using a 10¥5 cancer risk
level is appropriate and consistent with
EPA guidance and past practice. Many
of these commenters stated that tribal
treaties did not confer rights to a
particular level of risk. Additionally,
some commenters supported EPA’s
consideration of downstream WQS in
Oregon when establishing the criteria
upstream, while others expressed
55 EPA’s
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85427
concern that EPA was suggesting that
Washington’s upstream criteria must be
identical to Oregon’s downstream
criteria and in doing so, acting
inconsistently with its 2014 Frequently
Asked Questions document on
downstream protection.56 For detailed
responses to these comments, see EPA’s
Response to Comment document in the
docket for this rule.
c. Relative Source Contribution
EPA recommends using a RSC for
non-carcinogens and nonlinear
carcinogens to account for sources of
exposure other than drinking water and
consumption of inland and nearshore
fish and shellfish (see section II.C.d). In
2015, after evaluating information on
chemical uses, properties, occurrences,
releases to the environment and
regulatory restrictions, EPA developed
chemical-specific RSCs for noncarcinogens and nonlinear carcinogens
ranging from 0.2 (20 percent) to 0.8 (80
percent) following the Exposure
Decision Tree approach described in
EPA’s 2000 Methodology.57 58 EPA
proposed to use these same RSCs to
derive human health criteria for
Washington, and where EPA did not
update the nationally recommended
criteria for certain pollutants in 2015,
EPA proposed to use a RSC of 0.2 to
derive human health criteria for those
pollutants in Washington to ensure
protectiveness.
Several commenters supported EPA’s
use of RSCs to account for other sources
of pollutant exposure. Several others
disagreed, arguing that water quality
criteria under the CWA cannot control
or consider sources of exposure other
than from drinking water and eating fish
and shellfish, so human health criteria
should not account for these sources.
Many of the commenters, in addition to
criticizing the concept of RSCs as
overly-conservative, argued that EPA
was double-counting exposure to
anadromous fish (which EPA considers
marine in the national dataset) by both
including them in the FCR and using
the pollutant-specific RSCs that EPA
pairs with an inland and nearshore-only
56 https://nepis.epa.gov/Exe/ZyPDF.cgi/
P100LIJF.PDF?Dockey=P100LIJF.PDF.
57 USEPA. 2000. Methodology for Deriving
Ambient Water Quality Criteria for the Protection
of Human Health. U.S. Environmental Protection
Agency, Office of Water, Washington, DC EPA–822–
B–00–004. https://www.epa.gov/wqc/humanhealth-water-quality-criteria.
58 Final Updated Ambient Water Quality Criteria
for the Protection of Human Health, (80 FR 36986,
June 29, 2015). See also: USEPA. 2015. Final 2015
Updated National Recommended Human Health
Criteria. U.S. Environmental Protection Agency,
Office of Water, Washington, DC https://
www.epa.gov/wqc/human-health-water-qualitycriteria.
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mstockstill on DSK3G9T082PROD with RULES
FCR in its 304(a) national recommended
human health criteria. Commenters
argued that this is inconsistent with
EPA’s guidance, which recommends
that states adjust the RSC to reflect a
greater proportion of the RfD being
attributed to water, fish and shellfish
intake in instances where the FCR
includes freshwater, estuarine and all
marine fish consumption.59 For detailed
responses to the comments, see EPA’s
Response to Comment document in the
docket for this rule.
Additionally, after further evaluation
of the proposed revised human health
criteria for antimony, EPA determined
that the existing 304(a) national
recommended criteria for antimony (last
updated in 2002) use a pollutantspecific RSC of 0.4. EPA intended to
apply a 0.2 RSC as a protective
approach only where pollutant-specific
RSCs were not already developed,
which is not the case for antimony.60
While the selected FCR of 175 g/day
does not include all marine fish (e.g., it
does not include consumption of
species such as swordfish, tuna, etc.),
EPA acknowledges that the criteria as
proposed may have double-counted
potential exposure to some pollutants in
certain marine fish that are anadromous
(e.g., salmon). Therefore, EPA reviewed
the RSCs in the proposed rule in light
of EPA’s guidance, which includes both
the Exposure Decision Tree and
associated discussion in EPA’s 2000
Methodology, as well as EPA’s
recommendation to adjust the RSC
when the FCR includes freshwater,
estuarine, and all marine fish
consumption. Arguably, EPA’s guidance
does not consider this exact scenario
where the selected FCR includes some,
but not all, species that EPA classifies
as marine in the national NHANES
dataset (and excludes some species that
EPA classifies as nearshore in the
national NHANES dataset, i.e.,
shellfish).
One way to adjust the RSC values to
account for inclusion of marine fish in
the FCR is to examine the ratio of the
national data characterizing all fish
consumption rates versus inland and
nearshore-only fish consumption rates
derived from the NHANES dataset, and
apply this ratio to the proportion of the
RfD reserved for inland and nearshore
59 USEPA. January 2013. Human Health Ambient
Water Quality Criteria and Fish Consumption Rates:
Frequently Asked Questions. https://www.epa.gov/
wqc/human-health-ambient-water-quality-criteriaand-fish-consumption-rates-frequently-asked.
60 https://nepis.epa.gov/Exe/
ZyPDF.cgi?Dockey=20003IEI.txt See also: National
Primary Drinking Water Regulations-Synthetic
Organic Chemicals and Inorganic Chemicals;
National Primary Drinking Water Regulations
Implementation, 57 FR 31776, July 17, 1992.
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fish consumption in the RSC. This
approach assumes that the pollutant
concentrations in anadromous fish are
the same as the pollutant concentrations
in inland and nearshore fish, which is
the same assumption inherent in
including multiple fish categories in the
FCR for criteria calculation. This
approach further assumes that the ratio
of all fish to inland and nearshore fish
from NHANES data approximates the
ratio of inland, nearshore, and
anadromous fish to just inland and
nearshore fish from CRITFC data. At the
90th percentile rate of consumption, the
national adult consumption rate from
NHANES data for all fish is 53 g/day
and 22 g/day for inland and nearshoreonly fish, or a ratio of 2.4. Applying this
to a RSC of 0.2 yields 0.48, or 0.5
rounding to a single decimal place.
Because the selected FCR includes some
but not all marine species, EPA decided
to use this approach to adjust the RSC
values. However, EPA only adjusted
RSC values to 0.5 for criteria
calculations previously using a RSC
between 0.2 and 0.5.
There are important considerations in
assigning a RSC, such as the total
number of potential exposure routes
from sources other than fish
consumption, which compels caution in
using this approach in all cases. As
such, EPA decided to retain RSC values
of 0.5 and above, recognizing the
compelling need to account for the other
potential exposure sources, including
marine fish not accounted for in the
FCR of 175 g/day, consistent with the
logic and procedures used in
establishing the national 304(a) criteria
recommendations. The Exposure
Decision Tree in EPA’s 2000
Methodology only recommends using a
RSC above 0.5 when there are no
significant known or potential uses/
sources other than the source of concern
(Box 7, Figure 4–1 in EPA’s 2000
Methodology) or there are sufficient
data available on each source to
characterize the exposure to those
sources (Box 8C, Figure 4–1). Neither of
these conditions are met for most of the
pollutants in the final rule for
Washington. EPA is not adjusting the
RSCs for pollutants that already have
national recommended RSCs greater
than or equal to 0.5 (2–
Chloronaphthalene (0.8), Endrin (0.8),
gamma-BHC/Lindane (0.5), and
methylmercury (2.7 × 10¥5 subtracted
from the RfD, which equates to a RSC
of approximately 0.73). See Table 1,
column B2 for a list of EPA’s final RSCs
by pollutant.
PO 00000
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d. Body Weight
EPA calculates final human health
criteria for Washington using a body
weight of 80 kg, which represents the
average weight of a U.S. adult and is
consistent with EPA’s 2015 updated
national default body weight (see
section II.C.c).61 Local tribal survey data
relevant to Washington are also
consistent with EPA’s national adult
body weight of 80 kg.62 Most
commenters were silent on EPA’s
proposal to use a body weight of 80 kg
to calculate human health criteria for
Washington. A few commenters were
concerned that 80 kg would not ensure
adequate protection of women and
children, and may not be representative
of all residents in Washington based on
limited local or regional data on body
weight specific to Washington residents.
EPA understands these concerns, but
decided that the survey on which EPA’s
national default of 80 kg is based
provides the most comprehensive
dataset to establish a body weight value
for deriving statewide human health
criteria for Washington, and is
consistent with the local tribal survey
data mentioned above. The data cited by
commenters do not provide sufficient
evidence to come up with an alternative
statewide body weight input parameter
since the studies cited are limited in
scope and pertain to specific
subpopulations. For detailed responses
to the comments, see EPA’s Response to
Comment document in the docket for
this rule.
e. Drinking Water Intake
EPA calculates final human health
criteria for Washington using a drinking
water intake rate of 2.4 L/day, consistent
with EPA’s 2015 updated national
default drinking water intake rate (see
section II.C.c).63 Most commenters were
61 Final Updated Ambient Water Quality Criteria
for the Protection of Human Health, (80 FR 36986,
June 29, 2015). See also: USEPA. 2015. Final 2015
Updated National Recommended Human Health
Criteria. U.S. Environmental Protection Agency,
Office of Water, Washington, DC https://
www.epa.gov/wqc/human-health-water-qualitycriteria.
62 USEPA Region 10. August 2007. Framework for
Selecting and Using Tribal Fish and Shellfish
Consumption Rates for Risk-Based Decision Making
at CERCLA and RCRA Cleanup Sites in Puget
Sound and the Strait of Georgia. Appendix B.
https://yosemite.epa.gov/r10/CLEANUP.NSF/
7780249be8f251538825650f0070bd8b/
e12918970debc8e488256da6005c428e/$FILE/
Tribal%20Shellfish%20Framework.pdf.
63 Final Updated Ambient Water Quality Criteria
for the Protection of Human Health, (80 FR 36986,
June 29, 2015). See also: USEPA. 2015. Final 2015
Updated National Recommended Human Health
Criteria. U.S. Environmental Protection Agency,
Office of Water, Washington, DC https://
www.epa.gov/wqc/human-health-water-qualitycriteria.
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silent on or agreed with EPA’s proposal
to use a drinking water intake rate of 2.4
L/day to calculate human health criteria
for Washington. However, two
commenters stated this input was
unnecessary in human health criteria
derivation. Since at least the 1980s, EPA
has included the drinking water
exposure pathway in the development
of human health criteria in order to
protect water bodies with a drinking
water designated use. EPA also provides
the option of using organism-only
human health criteria for water bodies
where there is no drinking water use.
One commenter stated that 2.4 L/day
was an underestimate, and expressed
concern that this value is not protective
of tribal members who consume more
water. EPA determined that it is
appropriate to use its 2015 final national
default drinking water intake rate, since
it was adjusted pursuant to public
comments after EPA issued the draft
national default rate of 3 L/day in 2014.
EPA acknowledges the concerns about
members of the target general
population who may consume larger
amounts of water, but EPA does not
have data (and did not receive any
during the public comment period) with
which to calculate a Washingtonspecific drinking water intake rate. For
detailed responses to the comments, see
EPA’s Response to Comment document
in the docket for this rule.
g. Pollutant-Specific Bioaccumulation
Factors
As part of EPA’s 2015 updates to its
304(a) recommended human health
criteria, EPA conducted a systematic
search of eight peer-reviewed, publicly
available sources to obtain the most
current toxicity values for each
pollutant (RfDs for non-carcinogenic
effects and CSFs for carcinogenic
effects).64 EPA calculates final human
health criteria for Washington using the
same toxicity values that EPA used in
its 2015 304(a) criteria updates, to
ensure that the resulting criteria are
based on a sound scientific rationale.
Where EPA did not update criteria for
certain pollutants in 2015 and those
pollutants are included in this final
rule, EPA uses the toxicity values that
the Agency used the last time it updated
its 304(a) criteria for those pollutants as
the best available scientific information.
See Table 1, columns B1 and B3 for a
For the 2015 national 304(a) human
health criteria update, EPA estimated
chemical-specific BAFs using a
framework for deriving national BAFs
described in EPA’s 2000 Methodology.65
Because the surveyed population upon
which the 175 g/day FCR is based
consumed almost exclusively trophic
level four fish (i.e., predator fish
species), EPA uses the trophic level four
BAF from the 2015 304(a) human health
criteria updates in conjunction with the
175 g/day FCR, in order to derive
protective criteria.66 Where in 2015,
EPA estimated BAFs from laboratorymeasured BCFs and therefore derived a
single pollutant-specific BAF for all
trophic levels, EPA uses those single
BAFs from the 2015 304(a) human
health criteria updates. Where EPA’s
existing 304(a) recommended human
health criteria for certain pollutants still
incorporate a BCF, and those pollutants
are included in this final rule, EPA uses
those BCFs as the best available
scientific information. See Table 1,
columns B4 and B5 for a list of EPA’s
64 Final Updated Ambient Water Quality Criteria
for the Protection of Human Health, (80 FR 36986,
June 29, 2015). See also: USEPA. 2015. Final 2015
Updated National Recommended Human Health
Criteria. U.S. Environmental Protection Agency,
Office of Water, Washington, DC https://
www.epa.gov/wqc/human-health-water-qualitycriteria.
65 USEPA. 2000. Methodology for Deriving
Ambient Water Quality Criteria for the Protection
of Human Health. U.S. Environmental Protection
Agency, Office of Water, Washington, DC EPA–822–
f. Pollutant-Specific Reference Doses
and Cancer Slope Factors
mstockstill on DSK3G9T082PROD with RULES
list of EPA’s final toxicity factors by
pollutant.
In general, commenters were
supportive of EPA using the latest and
most scientifically defensible toxicity
values to derive human health criteria
for Washington. Some commenters
expressed concern that where EPA did
not update its 304(a) national
recommended human health criteria for
particular pollutants in 2015, the
toxicity values from the existing 304(a)
criteria for those pollutants were no
longer valid. In particular, those
commenters expressed concern about
the CSFs for arsenic and PCBs, and the
RfD for methylmercury, and argued that
EPA should not revise Washington’s
criteria for those pollutants until
toxicity factors are updated in the
future. Unlike the situation with the
toxicity factors for arsenic, dioxin and
thallium (see section III.A), there is not
sufficient scientific uncertainty
surrounding the CSF for PCBs or the
RfD for methylmercury to warrant
delaying revision to Washington’s
human health criteria for these
pollutants. For detailed responses to the
comments, see EPA’s Response to
Comment document in the docket for
this rule.
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85429
final bioaccumulation factors by
pollutant.
Many commenters supported EPA’s
choice to use the latest and most
scientifically defensible BAFs to derive
human health criteria for Washington,
and to use BCFs only when BAFs were
not available for a given pollutant. Other
commenters asserted that BCFs are no
less scientifically defensible than BAFs,
and that EPA did not provide sufficient
information regarding how it developed
BAFs in 2015 for commenters to fully
evaluate EPA’s proposed approach.
EPA’s 2000 Methodology
recommends use of BAFs that account
for uptake of a contaminant from all
sources by fish and shellfish, rather than
BCFs that only account for uptake from
the water column. EPA’s 2015 national
recommended BAFs are based on peerreviewed, publicly available data and
were developed consistent with EPA’s
2000 Methodology and its supporting
documents. EPA provided the basis for
its 2015 BAFs in individual pollutantspecific criteria documents. The final
human health criteria for Washington
are consistent with EPA’s 2000
Methodology, which makes clear that
BAFs are a more scientifically
defensible representation of
bioaccumulation than BCFs. For
detailed responses to the comments, see
EPA’s Response to Comment document
in the docket for this rule.
D. Final Human Health Criteria for
Washington
EPA finalizes 144 human health
criteria for 74 different pollutants (72
organism-only criteria and 72 waterplus-organism criteria) to protect the
applicable designated uses of
Washington’s waters (see Table 1). The
water-plus-organism criteria in column
C1 and the methylmercury criterion in
column C2 of Table 1 are the applicable
criteria for any waters that include the
Domestic Water (domestic water supply)
use defined in Washington’s WQS
(WAC 173–201A–600). The organismonly criteria in column C2 of Table 1
apply to waters that do not include the
Domestic Water (domestic water supply)
use and that Washington defines at
WAC 173–201A–600 and 173–201A–
610 as the following: Fresh waters—
Harvesting (fish harvesting), and
Recreational Uses; Marine waters—
Shellfish Harvesting (shellfish—clam,
oyster, and mussel—harvesting),
Harvesting (salmonid and other fish
B–00–004. https://www.epa.gov/wqc/humanhealth-water-quality-criteria.
66 Fish Consumption Survey of the Umatilla, Nez
Perce, Yakama, and Warm Springs Tribes of the
Columbia River Basin (Columbia River Inter-Tribal
Fish Commission (CRITFC), 1994)
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harvesting, and crustacean and other
shellfish—crabs, shrimp, scallops, etc.—
harvesting), and Recreational Uses.
TABLE 1—HUMAN HEALTH CRITERIA FOR WASHINGTON
A
B
C
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CAS No.
1. 1,1,1-4Trichloroethane ....................
2. 1,1,2,2-Tetrachloroethane ...............
3. 1,1,2-Trichloroethane ......................
4. 1,1-Dichloroethylene .......................
5. 1,2,4-Trichlorobenzene ...................
6. 1,2-Dichlorobenzene .......................
7. 1,2-Dichloroethane ..........................
8. 1,2-Dichloropropane ........................
9. 1,2-Diphenylhydrazine ....................
10. 1,2-Trans-Dichloroethylene ...........
11. 1,3-Dichlorobenzene .....................
12. 1,3-Dichloropropene ......................
13. 1,4-Dichlorobenzene .....................
14. 2,3,7,8–TCDD (Dioxin) ** ..............
15. 2,4,6-Trichlorophenol ....................
16. 2,4-Dichlorophenol ........................
17. 2,4-Dimethylphenol .......................
18. 2,4-Dinitrophenol ...........................
19. 2,4-Dinitrotoluene ..........................
20. 2-Chloronaphthalene .....................
21. 2-Chlorophenol ..............................
22. 2-Methyl-4,6-Dinitrophenol ............
23. 3,3′-Dichlorobenzidine ..................
24. 3-Methyl-4-Chlorophenol ...............
25. 4,4′-DDD .......................................
26. 4,4′-DDE .......................................
27. 4,4′-DDT ........................................
28. Acenaphthene ...............................
29. Acrolein .........................................
30. Acrylonitrile ....................................
31. Aldrin .............................................
32. alpha-BHC .....................................
33. alpha-Endosulfan ..........................
34. Anthracene ....................................
35. Antimony .......................................
36. Arsenic ** .......................................
37. Asbestos .......................................
38. Benzene ........................................
39. Benzidine ......................................
40. Benzo(a) Anthracene ....................
41. Benzo(a) Pyrene ...........................
42. Benzo(b) Fluoranthene .................
43. Benzo(k) Fluoranthene .................
44. beta-BHC ......................................
45. beta-Endosulfan ............................
46. Bis(2-Chloroethyl) Ether ................
47. Bis(2-Chloro-1-Methylethyl) Ether *
48. Bis(2-Ethylhexyl) Phthalate ...........
49. Bromoform ....................................
50. Butylbenzyl Phthalate ...................
51. Carbon Tetrachloride ....................
52. Chlordane ......................................
53. Chlorobenzene ..............................
54. Chlorodibromomethane .................
55. Chloroform ....................................
56. Chrysene .......................................
57. Copper ..........................................
58. Cyanide .........................................
59. Dibenzo(a,h) Anthracene ..............
60. Dichlorobromomethane .................
61. Dieldrin ..........................................
62. Diethyl Phthalate ...........................
63. Dimethyl Phthalate ........................
64. Di-n-Butyl Phthalate ......................
65. Endosulfan Sulfate ........................
66. Endrin ............................................
67. Endrin Aldehyde ............................
68. Ethylbenzene ................................
69. Fluoranthene .................................
70. Fluorene ........................................
71. gamma-BHC; Lindane ..................
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1746016
88062
120832
105679
51285
121142
91587
95578
534521
91941
59507
72548
72559
50293
83329
107028
107131
309002
319846
959988
120127
7440360
7440382
1332214
71432
92875
56553
50328
205992
207089
319857
33213659
111444
108601
117817
75252
85687
56235
57749
108907
124481
67663
218019
7440508
57125
53703
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60571
84662
131113
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Cancer
slope factor,
CSF
(per mg/
kg·d)
Relative
source
contribution,
RSC (-)
Reference
dose, RfD
(mg/kg·d)
Bio-accumulation
factor
(L/kg tissue)
Bio-concentration
factor
(L/kg tissue)
Water &
organisms
(μg/L)
Organisms
only
(μg/L)
(B1)
Chemical
(B2)
(B3)
(B4)
(B5)
(C1)
(C2)
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.80
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.80
0.50
0.50
0.50
0.50
2
....................
....................
0.05
....................
0.3
....................
....................
....................
0.02
0.002
....................
0.07
....................
....................
0.003
....................
0.002
....................
0.08
....................
0.0003
....................
....................
....................
....................
....................
0.06
....................
....................
....................
....................
0.006
0.3
0.0004
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
0.04
....................
....................
....................
....................
....................
0.02
....................
0.01
....................
....................
0.0006
....................
....................
....................
0.8
10
0.1
0.006
0.0003
....................
0.022
0.04
0.04
0.0047
10
8.4
8.9
2.6
430
82
1.9
............................
27
4.7
190
3.0
84
............................
............................
48
............................
4.4
............................
240
............................
10
............................
............................
240,000
3,100,000
1,100,000
510
............................
............................
650,000
1,500
200
610
............................
............................
............................
............................
............................
3,900
3,900
3,900
3,900
180
............................
............................
10
710
8.5
19,000
............................
60,000
22
5.3
3.8
3,900
............................
............................
3,900
4.8
410,000
920
4,000
2,900
140
46,000
............................
160
1,500
710
2,500
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
5,000
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
1
44
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
1
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
20,000
0.1
0.35
700
0.036
700
8.9
..................
0.01
200
2
0.22
200
1.3E–08
..................
10
..................
30
..................
100
..................
3
..................
..................
7.9E–06
8.8E–07
1.2E–06
30
..................
..................
4.1E–08
4.8E–05
6
100
6
a 0.018
..................
..................
..................
0.00016
1.6E–05
0.00016
0.0016
0.0013
..................
..................
400
0.045
4.6
0.013
..................
2.2E–05
100
0.60
100
0.016
..................
9
1.6E–05
0.73
7.0E–08
200
600
8
9
0.002
..................
29
6
10
0.43
50,000
0.3
0.90
4,000
0.037
800
73
........................
0.02
1,000
2
1.2
200
1.4E–08
........................
10
........................
100
........................
100
........................
7
........................
........................
7.9E–06
8.8E–07
1.2E–06
30
........................
........................
4.1E–08
4.8E–05
7
100
90
a 0.14
........................
........................
........................
0.00016
1.6E–05
0.00016
0.0016
0.0014
........................
........................
900
0.046
12
0.013
........................
2.2E–05
200
2.2
600
0.016
........................
100
1.6E–05
2.8
7.0E–08
200
600
8
........................
0.002
........................
31
6
10
0.43
Fmt 4700
Sfmt 4700
....................
0.2
0.057
....................
0.029
....................
0.0033
....................
0.8
....................
....................
0.122
....................
156,000
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
0.24
0.167
0.34
....................
....................
....................
17
6.3
....................
....................
....................
1.75
....................
....................
....................
0.73
7.3
0.73
0.073
1.8
....................
....................
....................
0.014
0.0045
0.0019
....................
0.35
....................
0.04
....................
0.0073
....................
....................
7.3
0.034
16
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
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Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations
TABLE 1—HUMAN HEALTH CRITERIA FOR WASHINGTON—Continued
A
B
C
72.
73.
74.
75.
76.
77.
78.
79.
80.
81.
82.
83.
84.
85.
86.
87.
88.
89.
90.
91.
92.
93.
94.
95.
96.
97.
98.
99.
CAS No.
Heptachlor .....................................
Heptachlor Epoxide .......................
Hexachlorobenzene ......................
Hexachlorobutadiene ....................
Hexachlorocyclopentadiene ..........
Hexachloroethane .........................
Indeno(1,2,3-cd) Pyrene ...............
Isophorone ....................................
Methyl Bromide .............................
Methylene Chloride .......................
Methylmercury ...............................
Nickel ............................................
Nitrobenzene .................................
N-Nitrosodimethylamine ................
N-Nitrosodi-n-Propylamine ............
N-Nitrosodiphenylamine ................
Pentachlorophenol (PCP) .............
Phenol ...........................................
Polychlorinated Biphenyls (PCBs)
Pyrene ...........................................
Selenium .......................................
Tetrachloroethylene ......................
Thallium ** .....................................
Toluene .........................................
Toxaphene ....................................
Trichloroethylene ...........................
Vinyl Chloride ................................
Zinc ...............................................
76448
1024573
118741
87683
77474
67721
193395
78591
74839
75092
22967926
7440020
98953
62759
621647
86306
87865
108952
................
129000
7782492
127184
7440280
108883
8001352
79016
75014
7440666
Relative
source
contribution,
RSC (-)
Reference
dose, RfD
(mg/kg·d)
Bio-accumulation
factor
(L/kg tissue)
Bio-concentration
factor
(L/kg tissue)
Water &
organisms
(μg/L)
Organisms
only
(μg/L)
(B1)
Chemical
Cancer
slope factor,
CSF
(per mg/
kg·d)
(B2)
(B3)
(B4)
(B5)
(C1)
(C2)
....................
....................
....................
....................
0.006
....................
....................
....................
0.02
....................
0.0001
0.02
0.002
....................
....................
....................
....................
0.6
....................
0.03
0.005
....................
0.000068
0.0097
....................
....................
....................
0.3
330,000
35,000
90,000
1,100
1,300
600
3,900
............................
1.4
1.6
............................
............................
3.1
............................
............................
............................
520
1.9
............................
860
............................
76
............................
17
............................
13
1.7
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
47
............................
............................
............................
............................
............................
............................
31,200
............................
4.8
............................
116
............................
............................
............................
............................
47
3.4E–07
2.4E–06
5.0E–06
0.01
1
0.02
0.00016
..................
300
10
..................
80
30
..................
..................
..................
0.002
9,000
c 7E–06
8
60
2.4
1.7
72
..................
0.3
..................
1,000
3.4E–07
2.4E–06
5.0E–06
0.01
1
0.02
0.00016
........................
........................
100
b 0.03 (mg/kg)
100
100
........................
........................
........................
0.002
70,000
c 7E–06
8
200
2.9
6.3
130
........................
0.7
0.18
1,000
4.1
5.5
1.02
0.04
....................
0.04
0.73
....................
....................
0.002
....................
....................
....................
....................
....................
....................
0.4
....................
2
....................
....................
0.0021
....................
....................
....................
0.05
1.5
....................
0.50
0.50
2.7E–05
0.50
0.50
0.50
0.50
0.50
0.50
0.50
a This
criterion refers to the inorganic form of arsenic only.
criterion is expressed as the fish tissue concentration of methylmercury (mg methylmercury/kg fish). See Water Quality Criterion for the Protection of Human
Health: Methylmercury (EPA–823–R–01–001, January 3, 2001) for how this value is calculated using the criterion equation in EPA’s 2000 Human Health Methodology
rearranged to solve for a protective concentration in fish tissue rather than in water.
c This criterion applies to total PCBs (e.g., the sum of all congener or isomer or homolog or Aroclor analyses).
* Bis(2-Chloro-1-Methylethyl) Ether was previously listed as Bis(2-Chloroisopropyl) Ether.
** These criteria were promulgated for Washington in the National Toxics Rule at 40 CFR 131.36, and are moved into 40 CFR 131.45 to have one comprehensive
human health criteria rule for Washington.
b This
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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
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Revisions to the Methodology for
Deriving Ambient Water Quality Criteria
for the Protection of Human Health (65
FR 66444, November 3, 2000), EPA now
recommends harmonic mean flow be
used to implement human health
criteria for both carcinogens and noncarcinogens.67 EPA received one
comment on this provision, asking for
clarification on whether this is
consistent with Washington’s current
permitting approach of using the 30Q5
flow for non-carcinogens.68 In response,
Washington’s use of low flow statistics
more stringent than the harmonic mean
flow is consistent with EPA’s final rule.
Under the CWA, Congress gave states
primary responsibility for developing
and adopting WQS for their navigable
waters (CWA section 303(a)-(c)).
67 See also USEPA. 2014. Water Quality
Standards Handbook—Chapter 5: General Policies.
U.S. Environmental Protection Agency. Office of
Water. Washington, DC EPA–820–B–14–004.
https://www.epa.gov/wqs-tech/water-qualitystandards-handbook.
68 The 30Q5 flow is the lowest 30-day average
flow event expected to occur once every five years,
on average (determined hydrologically).
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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
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and thallium) into 40 CFR 131.45 so
there is a single comprehensive set of
federally promulgated criteria for
Washington. Therefore, the CWAeffective numeric human health criteria
in Washington consist of the federally
promulgated criteria at 40 CFR 131.45
and those criteria that EPA approved at
WAC 173–201A–240 in Washington’s
August 1, 2016 submittal.
Additionally, in its September 14,
2015 proposed rule, EPA proposed that
if Washington adopted and submitted
human health criteria after EPA
finalized its rule, once EPA approved
Washington’s WQS, the pollutantspecific or site-specific EPA-approved
criteria in Washington’s WQS would
become the solely effective criteria for
CWA purposes and EPA’s promulgated
criteria for those pollutants or for that
site would no longer apply. A few
commenters supported this provision,
where Washington’s criteria for specific
pollutants or sites become the only
CWA-effective criteria upon EPA’s
approval, without any delay caused by
EPA’s withdrawal of the corresponding
federal criteria. A few other commenters
did not support this provision, and
asked that EPA either delete the
provision, or make clear that criteria
adopted by the state would have to be
at least as stringent as the federal
criteria for EPA to approve and make
the state criteria effective for CWA
purposes. Upon further consideration of
comments received on its proposed rule,
EPA decided not to finalize this
provision. Pursuant to 40 CFR 131.21(c),
EPA’s federally promulgated WQS are
and will be applicable for purposes of
the CWA until EPA withdraws those
federally promulgated WQS. EPA would
undertake such a rulemaking to
withdraw the federal criteria if and
when Washington adopts and EPA
approves corresponding criteria that
meet the requirements of section 303(c)
of the CWA and EPA’s implementing
regulations at 40 CFR part 131.
F. Alternative Regulatory Approaches
and Implementation Mechanisms
Washington has considerable
discretion to implement these revised
and new federal human health criteria
through various water quality control
programs including the NPDES
program, which limits discharges to
waters except in compliance with a
NPDES permit. EPA’s regulations at 40
CFR 131.14 authorize states and
authorized tribes to adopt WQS
variances to provide time to achieve the
applicable WQS. 40 CFR part 131
defines WQS variances at 131.3(o) as
time-limited designated uses and
supporting criteria for a specific
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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
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final rule change, any of the flexibilities
already afforded to Washington by
EPA’s regulations to modify or remove
designated uses, adopt variances, issue
compliance schedules, or establish sitespecific criteria. These implementation
tools are important for making
incremental progress and allowing the
time for adaptive management when
designated uses and associated criteria
are difficult to attain. Washington may
continue to use any of these regulatory
flexibilities when implementing the
final federal human health criteria.
a. Designating Uses
EPA’s final human health criteria
apply to waters that Washington has
designated for the following: Fresh
waters—Harvesting (fish harvesting),
Domestic Water (domestic water
supply), and Recreational Uses; Marine
waters—Shellfish Harvesting
(shellfish—clam, oyster, and mussel—
harvesting), Harvesting (salmonid and
other fish harvesting, and crustacean
and other shellfish—crabs, shrimp,
scallops, etc.—harvesting), and
Recreational Uses (see WAC 173–201A–
600 and WAC 173–201A–610). If
Washington removes the Domestic
Water use but retains any of the other
above designated uses for any particular
waterbody affected by this final rule,
and EPA finds that removal to be
consistent with CWA section 303(c) and
EPA’s implementing regulations at 40
CFR part 131, then the federal organismonly criteria will apply in place of the
federal water-plus-organism criteria. If
Washington removes designated uses
such that none of the above uses apply
to any particular waterbody affected by
this final rule and adopts the highest
attainable use, as defined by 40 CFR
131.3(m), consistent with 40 CFR
131.10(g), and EPA finds that removal to
be consistent with CWA section 303(c)
and EPA’s implementing regulations at
40 CFR part 131, then the federal human
health criteria will no longer apply to
that waterbody. Instead, any criteria
associated with the newly designated
highest attainable use would apply to
that waterbody.
b. Variances and Compliance Schedules
EPA’s final human health criteria
apply to use designations that
Washington has already established.
Concurrent with this final rule, EPA
approved revisions to Washington’s
variance and compliance schedule
authorizing provisions. Washington may
use its EPA-approved variance
procedures (see WAC 173–201A–420) to
establish time-limited designated uses
and criteria to apply for the purposes
specified in 40 CFR 131.14 as it pertains
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to federal criteria when adopting such
variances. Washington has sufficient
authority to use variances when
implementing the human health criteria
as long as such variances are adopted
consistent with 40 CFR 131.14, and
submitted to EPA for review under
CWA section 303(c). Similarly,
Washington may use its EPA-approved
regulation authorizing the use of permit
compliance schedules (see WAC 173–
201A–510(4)), consistent with 40 CFR
131.15, to grant compliance schedules,
as appropriate, for WQBELs based on
the federal criteria. These state
regulations are not affected by this final
rule.
c. Site-Specific Criteria
As discussed in section III.E, if
Washington adopts and EPA approves
site-specific criteria that fully meet the
requirements of section 303(c) of the
CWA and EPA’s implementing
regulations at 40 CFR part 131, EPA will
undertake a rulemaking to withdraw the
corresponding federal criteria.
IV. Economic Analysis
Under the CWA, water quality criteria
are set on the basis of the latest
scientific knowledge. EPA is not
required under the CWA nor obligated
under Executive Orders 12866 and
13563 to conduct an economic analysis
of the criteria. Costs cannot be
considered in establishing water quality
criteria as part of WQS. Nonetheless,
EPA conducted a cost analysis for the
criteria in this final rule for the purpose
of transparency and presents this
information reflecting the potential
economic effects of the rule.
These WQS may serve as a basis for
development of NPDES permit limits.
Washington has NPDES permitting
authority, and retains considerable
discretion in implementing standards.
EPA evaluated the potential costs to
NPDES dischargers associated with state
implementation of EPA’s final criteria.
This analysis is documented in Final
Economic Analysis for the Revision of
Certain Federal Water Quality Criteria
Applicable to Washington, which can be
found in the record for this rulemaking.
Any NPDES-permitted facility that
discharges pollutants for which the
revised human health criteria are more
stringent than the applicable aquatic life
criteria (or for which human health
criteria are the only applicable criteria)
could potentially incur compliance
costs. The types of affected facilities
could include industrial facilities and
POTWs discharging wastewater to
surface waters (i.e., point sources). EPA
did not attribute compliance with water
quality-based effluent limitations
(WQBELs) reflective of existing federal
human health criteria applicable to
Washington (hereafter referred to as
‘‘baseline criteria’’) to the final rule.
Once in compliance with WQBELs
reflective of baseline criteria, EPA
expects that dischargers will continue to
use the same types of controls to come
85433
into compliance with the revised
criteria; EPA did not fully evaluate the
potential for costs to nonpoint
sources,69 such as agricultural runoff,
that could be incurred under a TMDL
for this analysis, but did analyze the
administrative costs to the state of
preparing TMDLs for potentially
incrementally impaired waters. Actual
costs of implementation of TMDLs is
beyond the scope of this analysis.
A. Identifying Affected Entities
EPA identified 406 point source
facilities that could ultimately be
affected by this final rule. Of these
potentially affected facilities, 73 are
major dischargers and 333 are minor
dischargers. EPA did not include
general permit facilities in its analysis
because data for such facilities are
limited, and flows are usually
negligible. Of the potentially affected
facilities, EPA evaluated a sample of 17
major facilities. Minor facilities are
unlikely to incur costs as a result of
implementation of the rule, because
minor facilities are typically those that
do not discharge toxics in toxic amounts
and discharge less than 1 million
gallons per day (mgd). Although lower
human health criteria could potentially
change this categorization, EPA did not
have effluent data on toxic pollutants to
evaluate minor facilities for this
analysis. Table 2 summarizes these
potentially affected facilities by type
and category.
TABLE 2—POTENTIALLY AFFECTED FACILITIES
Category
Minor
Major
All
Municipal ......................................................................................................................................
Industrial ......................................................................................................................................
184
149
48
25
232
174
Total ......................................................................................................................................
333
73
406
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B. Method for Estimating Costs
EPA evaluated the two major
municipal facilities with design flows
greater than 100 mgd and a large
industrial refinery, to attempt to capture
the facilities with the potential for the
largest costs. For the remaining major
facilities, EPA evaluated a random
sample of facilities to represent
discharger type and category. For all
sample facilities, EPA evaluated existing
baseline permit conditions, reasonable
potential to exceed human health
criteria based on the final rule, and
potential to exceed projected effluent
limitations based on the last three years
of effluent monitoring data (if available).
In instances of exceedances of projected
effluent limitations under the final
criteria, EPA determined the likely
compliance scenarios and costs. Only
compliance actions and costs that
would be needed above the baseline
level of controls are attributable to the
final rule.
EPA assumed that dischargers will
pursue the least cost means of
compliance with WQBELs. Incremental
compliance actions attributable to the
final rule may include pollution
prevention, end-of-pipe treatment, and
alternative compliance mechanisms
(e.g., variances). EPA annualized one-
69 The CWA does not regulate nonpoint sources.
However, EPA recognizes that the state may require
controls for nonpoint sources as part of potential
incremental TMDLs. It is difficult to model and
evaluate the potential cost impacts of this final rule
to nonpoint sources because they are intermittent,
variable, and occur under hydrologic or climatic
conditions associated with precipitation events.
Also, data on instream and discharge levels of the
pollutants of concern after dischargers have
implemented controls to meet current WQS, total
maximum daily loads (TMDLs) for impaired waters,
or other water quality improvement plans, are not
available. Therefore, trying to determine which
sources would not achieve WQS based on the
revised human health criteria after complying with
existing regulations and policies may not be
possible. In addition, legacy contamination (e.g., in
sediment) may be a source of ongoing loading.
Atmospheric deposition may also contribute
loadings of the pollutants of concern (e.g., mercury).
EPA did not estimate sediment remediation costs,
or air pollution controls costs, for this analysis
because EPA did not have data on the contribution
of these sources, and because control costs for
deposition may be covered by Clean Air Act rules.
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time costs (capital costs and variance
costs) over 20 years using a 3 percent
discount rate to obtain total annual costs
per facility. For the random sample,
EPA extrapolated the annualized costs
based on the sampling weight for each
sample facility. To obtain an estimate of
total costs to point sources, EPA added
the results for the certainty sample to
the extrapolated random sample costs.
C. Results
Based on the results for 17 sample
facilities across 8 industrial and
municipal categories,70 EPA estimated a
total annual compliance cost of
approximately $126,000 to $150,000 for
all major dischargers in the state (using
a 3 percent discount rate). Only five
facilities are estimated to incur
pollution prevention program costs,
while two facilities are expected to also
incur costs of obtaining a variance. Most
of the facilities would not bear any cost.
The low end of the range reflects the
assumption that the compliance actions
(e.g., pollution prevention) will result in
compliance with projected effluent
limits, whereas the high scenario
reflects projected effluent limits not
being met, and thus includes the
estimated administrative cost of also
obtaining a variance. All compliance
costs are for industrial facilities, and are
attributable to the human health
criterion for methylmercury.
If the revised criteria result in an
incremental increase in impaired
waters, resulting in the need for TMDL
development, there could also be some
costs to nonpoint sources of pollution.
Using available ambient monitoring
data, EPA compared pollutant
concentrations to the baseline and final
criteria, identifying waterbodies that
may be incrementally impaired (i.e.,
impaired under the final criteria but not
under the baseline). For the parameters
and stations for which EPA had
sufficient monitoring data available to
evaluate, there were 50 impairments
under the baseline criteria and 124
under the final criteria, for a total of 74
potential incremental impairments (or a
148 percent increase relative to the
baseline; including for methylmercury,
PCBs, and DDT). This increase indicates
the potential for nonpoint sources to
bear some compliance costs, although
data are not available to estimate the
magnitude of these costs. The control of
nonpoint sources such as in the context
of a TMDL could result in different
70 Seven industrial categories (mining, food and
kindred products, paper and allied products,
chemicals and allied products, petroleum refining
and related industries, primary metal industries,
and transportation and public utilities (except
POTWs)) and municipal POTWs.
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requirements, and thus different costs,
for point sources.
If the net increase in potential
impairments is any indication of the
potential increase in the number of
TMDLs, then the total administrative
costs for TMDL development could be
in the range of $2.7 million to $3.0
million based on national average
single-cause single-waterbody TMDL
development costs from U.S. EPA (2001;
updated to 2014 dollars). However,
these costs may be reduced if Ecology
develops multi-cause or multiwaterbody TMDLs. If these costs are
spread over 8 to 15 years, at a discount
rate of 3 percent, the annualized costs
of developing TMDLs are $229,000 to
$422,000.
Combining the potential facility
compliance costs and TMDL
administrative costs results in total
annual costs of $355,000 to $572,000, at
a 3 percent discount rate.
V. Statutory and Executive Order
Reviews
A. Executive Order 12866 (Regulatory
Planning and Review) and Executive
Order 13563 (Improving Regulation and
Regulatory Review)
It has been determined that this final
rule is not a ‘‘significant regulatory
action’’ under the terms of Executive
Order 12866 (58 FR 51735, October 4,
1993) and is, therefore, not subject to
review under Executive Orders 12866
and 13563 (76 FR 3821, January 21,
2011). The final rule does not establish
any requirements directly applicable to
regulated entities or other sources of
toxic pollutants. However, these WQS
may serve as a basis for development of
NPDES permit limits. Washington has
NPDES permitting authority, and retains
considerable discretion in implementing
standards. In the spirit of Executive
Order 12866, EPA evaluated the
potential costs to NPDES dischargers
associated with state implementation of
EPA’s final criteria. This analysis, Final
Economic Analysis for the Revision of
Certain Federal Water Quality Criteria
Applicable to Washington, is
summarized in section IV of the
preamble and is available in the docket.
B. Paperwork Reduction Act
This action does not impose any
direct new information collection
burden under the provisions of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq. Actions to implement these
WQS could entail additional paperwork
burden. Burden is defined at 5 CFR
1320.3(b). This action does not include
any information collection, reporting, or
record-keeping requirements.
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C. Regulatory Flexibility Act
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA. This action will not
impose any requirements on small
entities. EPA has the authority to
promulgate WQS in any case where the
Administrator determines that a new or
revised standard is necessary to meet
the requirements of the CWA. EPApromulgated standards are implemented
through various water quality control
programs including the NPDES
program, which limits discharges to
navigable waters except in compliance
with an NPDES permit. The CWA
requires that all NPDES permits include
any limits on discharges that are
necessary to meet applicable WQS.
Thus, under the CWA, EPA’s
promulgation of WQS establishes
standards that the state implements
through the NPDES permit process. The
state has discretion in developing
discharge limits, as needed to meet the
standards. As a result of this action, the
State of Washington will need to ensure
that permits it issues include any
limitations on discharges necessary to
comply with the standards established
in the final rule. In doing so, the state
will have a number of choices
associated with permit writing. While
Washington’s implementation of the
rule may ultimately result in new or
revised permit conditions for some
dischargers, including small entities,
EPA’s action, by itself, does not impose
any of these requirements on small
entities; that is, these requirements are
not self-implementing.
D. Unfunded Mandates Reform Act
This action contains no federal
mandates under the provisions of Title
II of the Unfunded Mandates Reform
Act of 1995 (UMRA), 2 U.S.C. 1531–
1538 for state, local, or tribal
governments or the private sector. As
these water quality criteria are not selfimplementing, EPA’s action imposes no
enforceable duty on any state, local or
tribal governments or the private sector.
Therefore, this action is not subject to
the requirements of sections 202 or 205
of UMRA.
This action is also not subject to the
requirements of section 203 of UMRA
because it contains no regulatory
requirements that could significantly or
uniquely affect small governments.
E. Executive Order 13132 (Federalism)
This action does not have federalism
implications. It will not have substantial
direct effects on the states, on the
relationship between the national
E:\FR\FM\28NOR1.SGM
28NOR1
Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government. This rule does not
alter Washington’s considerable
discretion in implementing these WQS,
nor will it preclude Washington from
adopting WQS in the future that EPA
concludes meet the requirements of the
CWA, which will eliminate the need for
federal standards. Thus, Executive
Order 13132 does not apply to this
action.
mstockstill on DSK3G9T082PROD with RULES
F. Executive Order 13175 (Consultation
and Coordination With Indian Tribal
Governments)
This action has tribal implications.
However, it will neither impose
substantial direct compliance costs on
federally recognized tribal governments,
nor preempt tribal law. In the State of
Washington, there are 29 federally
recognized Indian tribes. To date, nine
of these Indian tribes have been
approved for TAS for CWA sections 303
and 401.71 Of these nine tribes, seven
have EPA-approved WQS in their
respective jurisdictions.72 This rule
could affect federally recognized Indian
tribes in Washington because the
numeric criteria for Washington will
apply to waters adjacent to (or upstream
or downstream of) the tribal waters,
where many of those tribes have treaty
rights to take fish for their subsistence.
Additionally, there are ten federally
recognized Indian tribes in the
Columbia River Basin located in the
states of Oregon and Idaho that this rule
could impact because their waters could
affect or be affected by the water quality
of Washington’s downstream or
upstream waters.
EPA consulted with federally
recognized tribal officials under EPA’s
Policy on Consultation and
Coordination with Indian Tribes early in
the process of developing this rule to
permit them to have meaningful and
timely input into its development. In
February and March 2015, EPA held
tribes-only technical staff and
leadership consultation sessions to hear
their views and answer questions of all
interested tribes on the proposed rule.
Representatives from approximately 23
tribes and four tribal consortia
participated in two leadership meetings
held in March 2015. EPA and tribes
71 https://water.epa.gov/scitech/swguidance/
standards/wqslibrary/approvtable.cfm.
72 https://yosemite.epa.gov/r10/water.nsf/
34090d07b77d50bd88256b79006529e8/dd2a4
df00fd7ae1a88256e0500680e86!OpenDocument.
Note that this number does not include the
Confederated Tribes of the Colville Reservation,
which has federally promulgated WQS from 1989.
EPA is currently reviewing the Colville Tribe’s
application for TAS.
VerDate Sep<11>2014
16:28 Nov 25, 2016
Jkt 241001
have also met regularly since November
2012 to discuss Washington’s human
health criteria at both the tribal
leadership level and technical staff
level. The tribes have repeatedly asked
EPA to promulgate federal human
health criteria for Washington if the
state did not do so in a timely and
protective manner. At these meetings,
the tribes consistently emphasized that
the human health criteria should be
derived using at least a minimum FCR
value of 175 g/day, a cancer risk level
of 10¥6, and the latest scientific
information from EPA’s 304(a)
recommended criteria. EPA considered
the input received during consultation
with tribes when developing this final
rule (see section III for additional
discussion of how EPA considered tribal
input).
In subsequent coordination with
tribes, EPA received a letter on August
5, 2016, from the Northwest Indian
Fisheries Commission disagreeing with
EPA’s potential adjustments to the RSC
from the proposed rule issued on
September 14, 2015 to the final rule as
a result of public comments. The tribes
expressed concern that less stringent
human health criteria as a result of the
RSC adjustment would result in lower
protection of designated uses and limit
the ability to exercise tribal treaty rights,
especially in light of a FCR that
underestimates tribal consumption. EPA
considered this information carefully
before finalizing this rule, but for the
reasons stated above, decided to adjust
the RSC to account for inclusion of
some marine fish in the FCR. This
results in protective criteria that account
for other routes of exposure in addition
to drinking water and fish and shellfish
from inland and nearshore waters and is
consistent with EPA’s guidance.
G. Executive Order 13045 (Protection of
Children From Environmental Health
and Safety Risks)
85435
I. National Technology Transfer and
Advancement Act of 1995
This final rulemaking does not
involve technical standards.
J. Executive Order 12898 (Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations)
This action will not have
disproportionately high and adverse
human health or environmental effects
on minority or low-income populations.
Conversely, this action identifies and
ameliorates disproportionately high and
adverse human health effects on
minority populations and low-income
populations in Washington. EPA
developed the human health criteria
included in this final rule specifically to
protect Washington’s designated uses,
using the most current science,
including local and regional information
on fish consumption. Applying these
criteria to waters in the State of
Washington will afford a greater level of
protection to both human health and the
environment.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and
EPA will submit a rule report to each
House of the Congress and to the
Comptroller General of the United
States. This action is not a ‘‘major rule’’
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 131
Environmental protection, Indianslands, Intergovernmental relations,
Reporting and recordkeeping
requirements, Water pollution control.
Dated: November 15, 2016.
Gina McCarthy,
Administrator.
For the reasons set forth in the
preamble, EPA amends 40 CFR part 131
as follows:
PART 131—WATER QUALITY
STANDARDS
1. The authority citation for part 131
continues to read as follows:
This rule is not subject to Executive
Order 13045, because it is not
economically significant as defined in
Executive Order 12866, and because the
environmental health or safety risks
addressed by this action do not present
a disproportionate risk to children.
■
H. Executive Order 13211 (Actions That
Significantly Affect Energy Supply,
Distribution, or Use)
■
This action is not a ‘‘significant
energy action’’ because it is not likely to
have a significant adverse effect on the
supply, distribution, or use of energy.
§ 131.45 Revision of certain Federal water
quality criteria applicable to Washington.
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
Authority: 33 U.S.C. 1251 et seq.
Subpart D—Federally Promulgated
Water Quality Standards
§ 131.36
[Amended]
2. In § 131.36, remove paragraph
(d)(14).
■ 3. Add § 131.45 to read as follows:
(a) Scope. This section promulgates
human health criteria for priority toxic
E:\FR\FM\28NOR1.SGM
28NOR1
85436
Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations
pollutants in surface waters in
Washington.
(b) Criteria for priority toxic
pollutants in Washington. The
applicable human health criteria are
shown in Table 1.
TABLE 1—HUMAN HEALTH CRITERIA FOR WASHINGTON
A
B
C
mstockstill on DSK3G9T082PROD with RULES
CAS No.
1. 1,1,1-Trichloroethane ......................
2. 1,1,2,2-Tetrachloroethane ...............
3. 1,1,2-Trichloroethane ......................
4. 1,1-Dichloroethylene .......................
5. 1,2,4-Trichlorobenzene ...................
6. 1,2-Dichlorobenzene .......................
7. 1,2-Dichloroethane ..........................
8. 1,2-Dichloropropane ........................
9. 1,2-Diphenylhydrazine ....................
10. 1,2-Trans-Dichloroethylene ...........
11. 1,3-Dichlorobenzene .....................
12. 1,3-Dichloropropene ......................
13. 1,4-Dichlorobenzene .....................
14. 2,3,7,8-TCDD (Dioxin) ** ...............
15. 2,4,6-Trichlorophenol ....................
16. 2,4-Dichlorophenol ........................
17. 2,4-Dimethylphenol .......................
18. 2,4-Dinitrophenol ...........................
19. 2,4-Dinitrotoluene ..........................
20. 2-Chloronaphthalene .....................
21. 2-Chlorophenol ..............................
22. 2-Methyl-4,6-Dinitrophenol ............
23. 3,3′-Dichlorobenzidine ..................
24. 3-Methyl-4-Chlorophenol ...............
25. 4,4′-DDD .......................................
26. 4,4′-DDE .......................................
27. 4,4′-DDT ........................................
28. Acenaphthene ...............................
29. Acrolein .........................................
30. Acrylonitrile ....................................
31. Aldrin .............................................
32. alpha-BHC .....................................
33. alpha-Endosulfan ..........................
34. Anthracene ....................................
35. Antimony .......................................
36. Arsenic ** .......................................
37. Asbestos .......................................
38. Benzene ........................................
39. Benzidine ......................................
40. Benzo(a) Anthracene ....................
41. Benzo(a) Pyrene ...........................
42. Benzo(b) Fluoranthene .................
43. Benzo(k) Fluoranthene .................
44. beta-BHC ......................................
45. beta-Endosulfan ............................
46. Bis(2-Chloroethyl) Ether ................
47. Bis(2-Chloro-1-Methylethyl) Ether *
48. Bis(2-Ethylhexyl) Phthalate ...........
49. Bromoform ....................................
50. Butylbenzyl Phthalate ...................
51. Carbon Tetrachloride ....................
52. Chlordane ......................................
53. Chlorobenzene ..............................
54. Chlorodibromomethane .................
55. Chloroform ....................................
56. Chrysene .......................................
57. Copper ..........................................
58. Cyanide .........................................
59. Dibenzo(a,h) Anthracene ..............
60. Dichlorobromomethane .................
61. Dieldrin ..........................................
62. Diethyl Phthalate ...........................
63. Dimethyl Phthalate ........................
64. Di-n-Butyl Phthalate ......................
65. Endosulfan Sulfate ........................
66. Endrin ............................................
67. Endrin Aldehyde ............................
68. Ethylbenzene ................................
69. Fluoranthene .................................
70. Fluorene ........................................
71. gamma-BHC; Lindane ..................
VerDate Sep<11>2014
16:28 Nov 25, 2016
71556
79345
79005
75354
120821
95501
107062
78875
122667
156605
541731
542756
106467
1746016
88062
120832
105679
51285
121142
91587
95578
534521
91941
59507
72548
72559
50293
83329
107028
107131
309002
319846
959988
120127
7440360
7440382
1332214
71432
92875
56553
50328
205992
207089
319857
33213659
111444
108601
117817
75252
85687
56235
57749
108907
124481
67663
218019
7440508
57125
53703
75274
60571
84662
131113
84742
1031078
72208
7421934
100414
206440
86737
58899
Jkt 241001
Cancer
slope factor,
CSF
(per mg/
kg·d)
Relative
source
contribution,
RSC (-)
Reference
dose, RfD
(mg/kg·d)
Bio-accumulation
factor
(L/kg tissue)
Bio-concentration
factor
(L/kg tissue)
Water &
organisms
(μg/L)
Organisms
only
(μg/L)
(B1)
Chemical
(B2)
(B3)
(B4)
(B5)
(C1)
(C2)
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.80
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.50
0.80
0.50
0.50
0.50
0.50
2
....................
....................
0.05
....................
0.3
....................
....................
....................
0.02
0.002
....................
0.07
....................
....................
0.003
....................
0.002
....................
0.08
....................
0.0003
....................
....................
....................
....................
....................
0.06
....................
....................
....................
....................
0.006
0.3
0.0004
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
0.04
....................
....................
....................
....................
....................
0.02
....................
0.01
....................
....................
0.0006
....................
....................
....................
0.8
10
0.1
0.006
0.0003
....................
0.022
0.04
0.04
0.0047
10
8.4
8.9
2.6
430
82
1.9
............................
27
4.7
190
3.0
84
............................
............................
48
............................
4.4
............................
240
............................
10
............................
............................
240,000
3,100,000
1,100,000
510
............................
............................
650,000
1,500
200
610
............................
............................
............................
............................
............................
3,900
3,900
3,900
3,900
180
............................
............................
10
710
8.5
19,000
............................
60,000
22
5.3
3.8
3,900
............................
............................
3,900
4.8
410,000
920
4,000
2,900
140
46,000
............................
160
1,500
710
2,500
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
5,000
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
1
44
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
1
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
20,000
0.1
0.35
700
0.036
700
8.9
..................
0.01
200
2
0.22
200
1.3E-08
..................
10
..................
30
..................
100
..................
3
..................
..................
7.9E-06
8.8E-07
1.2E-06
30
..................
..................
4.1E-08
4.8E-05
6
100
6
a 0.018
..................
..................
..................
0.00016
1.6E-05
0.00016
0.0016
0.0013
..................
..................
400
0.045
4.6
0.013
..................
2.2E-05
100
0.60
100
0.016
..................
9
1.6E-05
0.73
7.0E-08
200
600
8
9
0.002
..................
29
6
10
0.43
50,000
0.3
0.90
4,000
0.037
800
73
........................
0.02
1,000
2
1.2
200
1.4E-08
........................
10
........................
100
........................
100
........................
7
........................
........................
7.9E-06
8.8E-07
1.2E-06
30
........................
........................
4.1E-08
4.8E-05
7
100
90
a 0.14
........................
........................
........................
0.00016
1.6E-05
0.00016
0.0016
0.0014
........................
........................
900
0.046
12
0.013
........................
2.2E-05
200
2.2
600
0.016
........................
100
1.6E-05
2.8
7.0E-08
200
600
8
........................
0.002
........................
31
6
10
0.43
Fmt 4700
Sfmt 4700
....................
0.2
0.057
....................
0.029
....................
0.0033
....................
0.8
....................
....................
0.122
....................
156,000
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
0.24
0.167
0.34
....................
....................
....................
17
6.3
....................
....................
....................
1.75
....................
....................
....................
0.73
7.3
0.73
0.073
1.8
....................
....................
....................
0.014
0.0045
0.0019
....................
0.35
....................
0.04
....................
0.0073
....................
....................
7.3
0.034
16
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
PO 00000
Frm 00036
E:\FR\FM\28NOR1.SGM
28NOR1
85437
Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations
TABLE 1—HUMAN HEALTH CRITERIA FOR WASHINGTON—Continued
A
B
C
72.
73.
74.
75.
76.
77.
78.
79.
80.
81.
82.
83.
84.
85.
86.
87.
88.
89.
90.
91.
92.
93.
94.
95.
96.
97.
98.
99.
CAS No.
Heptachlor .....................................
Heptachlor Epoxide .......................
Hexachlorobenzene ......................
Hexachlorobutadiene ....................
Hexachlorocyclopentadiene ..........
Hexachloroethane .........................
Indeno(1,2,3-cd) Pyrene ...............
Isophorone ....................................
Methyl Bromide .............................
Methylene Chloride .......................
Methylmercury ...............................
Nickel ............................................
Nitrobenzene .................................
N-Nitrosodimethylamine ................
N-Nitrosodi-n-Propylamine ............
N-Nitrosodiphenylamine ................
Pentachlorophenol (PCP) .............
Phenol ...........................................
Polychlorinated Biphenyls (PCBs)
Pyrene ...........................................
Selenium .......................................
Tetrachloroethylene ......................
Thallium ** .....................................
Toluene .........................................
Toxaphene ....................................
Trichloroethylene ...........................
Vinyl Chloride ................................
Zinc ...............................................
76448
1024573
118741
87683
77474
67721
193395
78591
74839
75092
22967926
7440020
98953
62759
621647
86306
87865
108952
................
129000
7782492
127184
7440280
108883
8001352
79016
75014
7440666
Relative
source
contribution,
RSC (-)
Reference
dose, RfD
(mg/kg·d)
Bio-accumulation
factor
(L/kg tissue)
Bio-concentration
factor
(L/kg tissue)
Water &
organisms
(μg/L)
Organisms
only
(μg/L)
(B1)
Chemical
Cancer
slope factor,
CSF
(per mg/
kg·d)
(B2)
(B3)
(B4)
(B5)
(C1)
(C2)
....................
....................
....................
....................
0.006
....................
....................
....................
0.02
....................
0.0001
0.02
0.002
....................
....................
....................
....................
0.6
....................
0.03
0.005
....................
0.000068
0.0097
....................
....................
....................
0.3
330,000
35,000
90,000
1,100
1,300
600
3,900
............................
1.4
1.6
............................
............................
3.1
............................
............................
............................
520
1.9
............................
860
............................
76
............................
17
............................
13
1.7
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
47
............................
............................
............................
............................
............................
............................
31,200
............................
4.8
............................
116
............................
............................
............................
............................
47
3.4E-07
2.4E-06
5.0E-06
0.01
1
0.02
0.00016
..................
300
10
..................
80
30
..................
..................
..................
0.002
9,000
c 7E-06
8
60
2.4
1.7
72
..................
0.3
..................
1,000
3.4E-07
2.4E-06
5.0E-06
0.01
1
0.02
0.00016
........................
........................
100
b 0.03 (mg/kg)
100
100
........................
........................
........................
0.002
70,000
c 7E-06
8
200
2.9
6.3
130
........................
0.7
0.18
1,000
4.1
5.5
1.02
0.04
....................
0.04
0.73
....................
....................
0.002
....................
....................
....................
....................
....................
....................
0.4
....................
2
....................
....................
0.0021
....................
....................
....................
0.05
1.5
....................
0.50
0.50
2.7E-05
0.50
0.50
0.50
0.50
0.50
0.50
0.50
a This
criterion refers to the inorganic form of arsenic only.
criterion is expressed as the fish tissue concentration of methylmercury (mg methylmercury/kg fish). See Water Quality Criterion for the Protection of Human
Health: Methylmercury (EPA–823–R–01–001, January 3, 2001) for how this value is calculated using the criterion equation in EPA’s 2000 Human Health Methodology
rearranged to solve for a protective concentration in fish tissue rather than in water.
c This criterion applies to total PCBs (e.g., the sum of all congener or isomer or homolog or Aroclor analyses).
* Bis(2-Chloro-1-Methylethyl) Ether was previously listed as Bis(2-Chloroisopropyl) Ether.
** These criteria were promulgated for Washington in the National Toxics Rule at 40 CFR 131.36, and are moved into 40 CFR 131.45 to have one comprehensive
human health criteria rule for Washington.
mstockstill on DSK3G9T082PROD with RULES
b This
(c) Applicability. (1) The criteria in
paragraph (b) of this section apply to
waters with Washington’s designated
uses cited in paragraph (d) of this
section and apply concurrently with
other applicable water quality criteria.
(2) The criteria established in this
section are subject to Washington’s
general rules of applicability in the
same way and to the same extent as are
other federally promulgated and stateadopted numeric criteria when applied
to the same use classifications in
paragraph (d) of this section.
(i) For all waters with mixing zone
regulations or implementation
procedures, the criteria apply at the
appropriate locations within or at the
boundary of the mixing zones;
otherwise the criteria apply throughout
the waterbody including at the end of
any discharge pipe, conveyance or other
discharge point within the waterbody.
(ii) The state must not use a low flow
value below which numeric noncarcinogen and carcinogen human
health criteria can be exceeded that is
less stringent than the harmonic mean
flow for waters suitable for the
VerDate Sep<11>2014
16:28 Nov 25, 2016
Jkt 241001
establishment of low flow return
frequencies (i.e., streams and rivers).
Harmonic mean flow is a long-term
mean flow value calculated by dividing
the number of daily flows analyzed by
the sum of the reciprocals of those daily
flows.
(iii) If the state does not have such a
low flow value for numeric criteria, then
none will apply and the criteria in
paragraph (b) of this section herein
apply at all flows.
(d) Applicable use designations. (1)
All waters in Washington assigned to
the following use classifications are
subject to the criteria identified in
paragraph (d)(2) of this section:
(i) Fresh waters—
(A) Miscellaneous uses: Harvesting
(Fish harvesting);
(B) Recreational uses;
(C) Water supply uses: Domestic
water (Domestic water supply);
(ii) Marine waters—
(A) Miscellaneous uses: Harvesting
(Salmonid and other fish harvesting,
and crustacean and other shellfish
(crabs, shrimp, scallops, etc.)
harvesting);
PO 00000
Frm 00037
Fmt 4700
Sfmt 9990
(B) Recreational uses;
(C) Shellfish harvesting: Shellfish
harvest (Shellfish (clam, oyster, and
mussel) harvesting)
Note to paragraph (d)(1): The source of
these uses is Washington Administrative
Code 173–201A–600 for Fresh waters and
173–201A–610 for Marine waters.
(2) For Washington waters that
include the use classification of
Domestic Water, the criteria in column
C1 and the methylmercury criterion in
column C2 of Table 1 in paragraph (b)
of this section apply. For Washington
waters that include any of the following
use classifications but do not include
the use classification of Domestic Water,
the criteria in column C2 of Table 1 in
paragraph (b) of this section apply:
Harvesting (fresh and marine waters),
Recreational Uses (fresh and marine
waters), and Shellfish Harvesting.
[FR Doc. 2016–28424 Filed 11–25–16; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\28NOR1.SGM
28NOR1
Agencies
[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Rules and Regulations]
[Pages 85417-85437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28424]
-----------------------------------------------------------------------
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
https://www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available electronically through https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Erica Fleisig, Office of Water,
Standards and Health Protection Division (4305T), Environmental
Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460;
telephone number: (202) 566-1057; email address: fleisig.erica@epa.gov.
SUPPLEMENTARY INFORMATION: This final rule is organized as follows:
I. General Information
A. Does this action apply to me?
B. How did EPA develop this final rule?
II. Background
A. Statutory and Regulatory Background
B. EPA's CWA 303(c) Action on Washington's Human Health Criteria
C. General Recommended Approach for Deriving Human Health
Criteria
III. Derivation of Human Health Criteria for Washington
A. Scope of Pollutants and Waters Covered by This Final Rule
B. Washington's Designated Uses and Tribal Reserved Fishing
Rights
C. Washington-Specific Human Health Criteria Inputs
D. Final Human Health Criteria for Washington
E. Applicability of Criteria
F. Alternative Regulatory Approaches and Implementation
Mechanisms
IV. Economic Analysis
A. Identifying Affected Entities
B. Method for Estimating Costs
C. Results
V. Statutory and Executive Order Reviews
A. Executive Order 12866 (Regulatory Planning and Review) and
Executive Order 13563 (Improving Regulation and Regulatory Review)
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132 (Federalism)
F. Executive Order 13175 (Consultation and Coordination With
Indian Tribal Governments)
G. Executive Order 13045 (Protection of Children From
Environmental Health and Safety Risks)
H. Executive Order 13211 (Actions That Significantly Affect
Energy Supply, Distribution, or Use)
I. National Technology Transfer and Advancement Act of 1995
J. Executive Order 12898 (Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations)
K. Congressional Review Act (CRA)
I. General Information
A. Does this action apply to me?
Entities such as industries, stormwater management districts, or
publicly owned treatment works (POTWs) that discharge pollutants to
waters of the United States under the State of Washington's
jurisdiction could be indirectly affected by this rulemaking, because
federal water quality standards (WQS) promulgated by EPA are applicable
to CWA regulatory programs, such as National Pollutant Discharge
Elimination System (NPDES) permitting. Citizens concerned with water
quality in Washington could also be interested in this rulemaking.
Categories and entities that could potentially be affected include the
following:
------------------------------------------------------------------------
Examples of potentially affected
Category entities
------------------------------------------------------------------------
Industry.......................... Industries discharging pollutants to
waters of the United States in
Washington.
Municipalities.................... Publicly owned treatment works or
other facilities discharging
pollutants to waters of the United
States in Washington.
Stormwater Management Districts... Entities responsible for managing
stormwater runoff in the State of
Washington.
------------------------------------------------------------------------
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities that could be indirectly affected
by this action. Any parties or entities who depend upon or contribute
to the water quality of Washington's waters could be indirectly
affected by this rule. To determine whether your facility or activities
could be indirectly affected by this action, you should carefully
examine this rule. If you have questions regarding the applicability of
this action to a particular entity, consult the person listed in the
FOR FURTHER INFORMATION CONTACT section.
B. How did EPA develop this final rule?
In developing this final rule, EPA carefully considered the public
comments and feedback received from interested parties. EPA originally
provided a 60-day public comment period after publishing the proposed
rule in the Federal Register on September 14, 2015.\1\ On October 28,
2015, in response to stakeholder requests,\2\ EPA extended the public
comment period for an additional 45 days.\3\ In addition, EPA held two
virtual public hearings on December 15th and 16th, 2015, to discuss the
contents of the proposed rule and accept verbal public comments.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
CWA section 303(c) (33 U.S.C. 1313(c)) directs states to adopt WQS
for their waters subject to the CWA. CWA section 303(c)(2)(A) and EPA's
implementing regulations at 40 CFR part 131 require, among other
things, that a state's WQS specify appropriate designated uses of the
waters, and water quality criteria that protect those uses. EPA's
regulations at 40 CFR 131.11(a)(1) provide that ``[s]uch criteria must
be based on sound scientific rationale and must contain sufficient
parameters or constituents to protect the designated use. For waters
with multiple use designations, the criteria shall support the most
sensitive use.'' In addition, 40 CFR 131.10(b) provides that ``[i]n
designating uses of a water body and the appropriate criteria for those
uses, the state shall take into consideration the water quality
standards of downstream waters and ensure that its water quality
standards provide for the attainment and maintenance of the water
quality standards of downstream waters.''
States are required to review applicable WQS at least once every
three years and, if appropriate, revise or adopt new standards (CWA
section 303(c)(1)). Any new or revised WQS must be submitted to EPA for
review and approval or disapproval (CWA section 303(c)(2)(A) and
(c)(3)). If EPA disapproves a state's new or revised WQS, the CWA
provides the state 90 days to adopt a revised WQS that meets CWA
requirements, and if it fails to do so, EPA shall promptly propose and
then within 90 days promulgate such standard unless EPA approves a
state replacement WQS first (CWA section 303(c)(3) and (c)(4)(A)). CWA
section 303(c)(4)(B) authorizes the Administrator to determine that a
new or revised standard is needed to meet CWA requirements. Upon making
such a determination, the CWA specifies that EPA shall promptly
propose, and then within 90 days promulgate, any such new or revised
standard unless prior to such promulgation, the state has adopted a
revised or new WQS that EPA determines to be in accordance with the
CWA.
Under CWA section 304(a), EPA periodically publishes criteria
recommendations for states to consider when adopting water quality
criteria for particular pollutants to protect the CWA section 101(a)(2)
goal uses. In 2015, EPA updated its 304(a) recommended criteria for
human health for 94 pollutants.\5\ Where EPA has published recommended
criteria, states should establish numeric water quality criteria based
on EPA's CWA section 304(a) criteria, section 304(a) criteria modified
to reflect site-specific conditions, or other scientifically defensible
methods (40 CFR 131.11(b)(1)). In all cases criteria must be sufficient
to protect the designated use and be based on sound scientific
rationale (40 CFR 131.11(a)(1)). CWA section 303(c)(2)(B) requires
states to adopt numeric criteria for all toxic pollutants listed
pursuant to CWA section 307(a)(1) for which EPA has published 304(a)
criteria, as necessary to support the states' designated uses.
---------------------------------------------------------------------------
\5\ Final Updated Ambient Water Quality Criteria for the
Protection of Human Health, (80 FR 36986, June 29, 2015). See also:
USEPA. 2015. Final 2015 Updated National Recommended Human Health
Criteria. U.S. Environmental Protection Agency, Office of Water,
Washington, DC https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------
In 1992, EPA promulgated the NTR at 40 CFR 131.36, establishing
chemical-specific numeric criteria for 85 priority toxic pollutants for
14 states and territories (states), including Washington, that were not
in compliance with the requirements of CWA section 303(c)(2)(B). When
states covered by the NTR subsequently adopted their own criteria for
toxic pollutants that EPA approved as consistent with the CWA and EPA's
implementing regulations, EPA amended the NTR to remove those criteria
for those states.
B. EPA's CWA 303(c) Action on Washington's Human Health Criteria
On September 14, 2015, EPA made a CWA 303(c)(4)(B) determination
that new or revised WQS for the protection of human health in
Washington were necessary to meet the requirements of the CWA, and
proposed revised human health criteria for the state (see 80 FR 55063).
At that time, Washington had not yet adopted its own criteria for the
protection of human health.\6\ On August 1, 2016, Washington adopted
and submitted statewide human health criteria and new and revised
implementation provisions. Concurrent with this final rule, EPA
approved 45 and disapproved 143 of Washington's human health criteria
under CWA 303(c). EPA is finalizing 144 human health criteria in this
rule in accordance with CWA section 303(c)(3) and (c)(4)
requirements.\7\ After the effective date of this final rule, these
federal criteria will be in effect for CWA purposes along with the
human health criteria that Washington adopted and EPA approved.
---------------------------------------------------------------------------
\6\ Washington adopted criteria for the protection of aquatic
life from toxic pollutants at WAC 173-201A-240.
\7\ EPA is finalizing a different number of human health
criteria (144) than it is disapproving (143) in Washington's 2016
submittal. Washington did not adopt organism-only criteria for
methylmercury or water-plus-organism and organism-only criteria for
bis(2-chloro-1-methylethyl) ether. These are priority pollutants
listed pursuant to CWA section 307(a)(1) for which EPA has 304(a)
recommended criteria, and, as such, CWA section 303(c)(2)(B)
requires that states adopt numeric criteria for these pollutants, as
necessary to support the states' designated uses. Therefore, EPA is
including these three criteria in this final rule for Washington.
This final rule, however, does not include revised water-plus-
organism and organism-only criteria for arsenic, as explained below
in section III.A, even though EPA is disapproving the arsenic
criteria in Washington's submittal.
---------------------------------------------------------------------------
Several commenters provided comments on the timing of EPA's rule,
and the relationship between EPA's federal rulemaking and the state
rulemaking process. These comments are now, for the most part, mooted
by EPA's finalization of its federal rule and action on the state's
submittal. For additional responses to specific comments, see EPA's
Response to Comment document in the docket for this rule.
C. General Recommended Approach for Deriving Human Health Criteria
Human health criteria are designed to minimize the risk of adverse
cancer and non-cancer effects occurring from lifetime exposure to
pollutants through the ingestion of drinking water and consumption of
fish and shellfish obtained from inland and nearshore waters (by
nearshore waters, EPA refers to waters out to three miles from the
coast). EPA's practice is to establish a human health 304(a)
recommended criterion for both drinking water and consumption of fish
and shellfish from inland and nearshore waters combined, and a separate
human health criterion based only on ingestion of fish and shellfish
from inland and nearshore waters. This latter criterion applies in
cases where the designated uses of a waterbody include supporting fish
and shellfish for human consumption but not drinking water supply
sources (e.g., in non-potable estuarine waters).
The criteria are based on two types of biological endpoints: (1)
Carcinogenicity and (2) systemic toxicity (i.e., all adverse effects
other than cancer). EPA takes an integrated approach and considers both
cancer and non-cancer effects when deriving human health criteria.
Where sufficient data are available, EPA derives criteria using
[[Page 85420]]
both carcinogenic and non-carcinogenic toxicity endpoints and
recommends the lower value. Human health criteria for carcinogenic
effects are calculated using the following input parameters: Cancer
slope factor (CSF), cancer risk level, body weight, drinking water
intake rate, fish consumption rate, and a bioaccumulation factor(s).
Human health criteria for non-carcinogenic and nonlinear carcinogenic
effects are calculated using a reference dose (RfD) in place of a CSF
and cancer risk level, and a relative source contribution (RSC) factor,
which is intended to ensure that an individual's total exposure to a
given pollutant from all sources does not exceed the RfD. Each of these
inputs is discussed in more detail below and in EPA's 2000 Human Health
Methodology (hereafter referred to as EPA's ``2000 Methodology'').\8\
---------------------------------------------------------------------------
\8\ USEPA. 2000. Methodology for Deriving Ambient Water Quality
Criteria for the Protection of Human Health. U.S. Environmental
Protection Agency, Office of Water, Washington, DC EPA-822-B-00-004.
https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------
a. Cancer Risk Level
EPA's 304(a) national recommended human health criteria are
typically based on the assumption that carcinogenicity is a ``non-
threshold phenomenon,'' which means that there are no ``no-effect''
levels, because even extremely small doses are assumed to cause a
finite increase in the incidence of cancer. Therefore, EPA calculates
304(a) human health criteria for carcinogenic effects as pollutant
concentrations corresponding to lifetime increases in the risk of
developing cancer.\9\ EPA calculates its 304(a) human health criteria
values at a 10-6 (one in one million) cancer risk level and
recommends cancer risk levels of 10-6 or 10-5
(one in one hundred thousand) for the general population.\10\ EPA notes
that states and authorized tribes can also choose a more stringent risk
level, such as 10-7 (one in ten million), when deriving
human health criteria.
---------------------------------------------------------------------------
\9\ As noted above, EPA recommends the criterion derived for
non-carcinogenic effects if it is more protective (lower) than that
derived for carcinogenic effects.
\10\ EPA's 2000 Methodology also states: ``Criteria based on a
10-5 risk level are acceptable for the general population
as long as states and authorized tribes ensure that the risk to more
highly exposed subgroups (sport fishers or subsistence fishers) does
not exceed the 10-4 level.'' Since EPA is establishing
final criteria to protect a target general population of tribes with
reserved subsistence fishing rights in Washington waters, the
applicable EPA-recommended cancer risk levels would relate to that
target general population, as opposed to the general population of
Washington residents overall. See section III for additional
discussion.
---------------------------------------------------------------------------
If the pollutant is not considered to have the potential for
causing cancer in humans (i.e., systemic toxicants), EPA assumes that
the pollutant has a threshold (the RfD) below which a physiological
mechanism exists to avoid or overcome the adverse effects of the
pollutant.
b. Cancer Slope Factor and Reference Dose
A dose-response assessment is required to understand the
quantitative relationships between exposure to a pollutant and the
onset of human health effects. EPA evaluates dose-response
relationships derived from animal toxicity and human epidemiological
studies to derive dose-response metrics. For carcinogenic toxicological
effects, EPA uses an oral CSF to derive human health criteria. The oral
CSF is an upper bound, approximating a 95 percent confidence limit, on
the increased cancer risk from a lifetime oral exposure to a stressor.
For non-carcinogenic effects, EPA uses the RfD to calculate human
health criteria. A RfD is an estimate of a daily oral exposure of an
individual to a substance that is likely to be without an appreciable
risk of deleterious effects during a lifetime. A RfD is typically
derived from a laboratory animal dosing study in which a no-observed-
adverse-effect level (NOAEL), lowest-observed-adverse-effect level
(LOAEL), or benchmark dose can be obtained. Uncertainty factors are
applied to reflect the limitations of the data. EPA's Integrated Risk
Information System (IRIS) \11\ was the primary source of toxicity
values (i.e., RfD and CSF) for EPA's 2015 updated 304(a) human health
criteria.\12\ For some pollutants, however, more recent peer-reviewed
and publicly available toxicological data were available from other EPA
program offices (e.g., Office of Pesticide Programs, Office of Water,
Office of Land and Emergency Management), other national and
international programs, and state programs.
---------------------------------------------------------------------------
\11\ USEPA. Integrated Risk Information System (IRIS). U.S.
Environmental Protection Agency, Office of Research and Development,
Washington, DC www.epa.gov/iris.
\12\ Final Updated Ambient Water Quality Criteria for the
Protection of Human Health, (80 FR 36986, June 29, 2015). See also:
USEPA. 2015. Final 2015 Updated National Recommended Human Health
Criteria. U.S. Environmental Protection Agency, Office of Water,
Washington, DC https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------
c. Exposure Assumptions
EPA's latest 304(a) national human health criteria use a default
drinking water intake rate of 2.4 liters per day (L/day) and default
rate of 22 g/day for consumption of fish and shellfish from inland and
nearshore waters, multiplied by pollutant-specific bioaccumulation
factors (BAFs) to account for the amount of the pollutant in the edible
portions of the ingested species. EPA's 2000 Methodology for deriving
human health criteria emphasizes using, when possible, measured or
estimated BAFs, which account for chemical accumulation in aquatic
organisms from all potential exposure routes.\13\ In the 2015 national
304(a) human health criteria update, EPA primarily used field-measured
BAFs, and laboratory-measured bioconcentration factors (BCFs) with
applicable food chain multipliers available from peer-reviewed,
publicly available databases, to develop national BAFs for three
trophic levels of fish. If this information was not available, EPA
selected octanol-water partition coefficients (Kow values)
from peer-reviewed sources for use in calculating national BAFs.\14\
---------------------------------------------------------------------------
\13\ USEPA. 2000. Methodology for Deriving Ambient Water Quality
Criteria for the Protection of Human Health. U.S. Environmental
Protection Agency, Office of Water, Washington, DC EPA-822-B-00-004.
https://www.epa.gov/wqc/human-health-water-quality-criteria.
\14\ Final Updated Ambient Water Quality Criteria for the
Protection of Human Health, (80 FR 36986, June 29, 2015). See also:
USEPA. 2015. Final 2015 Updated National Recommended Human Health
Criteria. U.S. Environmental Protection Agency, Office of Water,
Washington, DC https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------
EPA's national default drinking water intake rate of 2.4 L/day
represents the per capita estimate of combined direct and indirect
community water ingestion at the 90th percentile for adults ages 21 and
older.\15\ EPA's national default FCR of 22 g/day represents the 90th
percentile consumption rate of fish and shellfish from inland and
nearshore waters for the U.S. adult population 21 years of age and
older, based on National Health and Nutrition Examination Survey
(NHANES) data from 2003 to 2010.16 17 EPA calculates
[[Page 85421]]
human health criteria using a default body weight of 80 kilograms (kg),
the average weight of a U.S. adult age 21 and older, based on NHANES
data from 1999 to 2006.
---------------------------------------------------------------------------
\15\ USEPA. 2011. EPA Exposure Factors Handbook. 2011 edition
(EPA 600/R-090/052F). https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=236252.
\16\ USEPA. 2014. Estimated Fish Consumption Rates for the U.S.
Population and Selected Subpopulations (NHANES 2003-2010). United
States Environmental Protection Agency, Washington, DC EPA 820-R-14-
002.
\17\ EPA's national FCR is based on the total rate of
consumption of fish and shellfish from inland and nearshore waters
(including fish and shellfish from local, commercial, aquaculture,
interstate, and international sources). This is consistent with a
principle that each state does its share to protect people who
consume fish and shellfish that originate from multiple
jurisdictions. USEPA. January 2013. Human Health Ambient Water
Quality Criteria and Fish Consumption Rates: Frequently Asked
Questions. https://www.epa.gov/wqc/human-health-ambient-water-quality-criteria-and-fish-consumption-rates-frequently-asked.
---------------------------------------------------------------------------
Although EPA uses these default values to calculate national 304(a)
recommended human health criteria, EPA's 2000 Methodology notes a
preference for the use of local data to calculate human health criteria
(e.g., locally derived FCRs, drinking water intake rates and body
weights, and waterbody-specific bioaccumulation rates) over national
default values, where data are sufficient to do so, to better represent
local conditions.\18\ It is also important, where sufficient data are
available, to select a FCR that reflects consumption that is not
suppressed by concerns about the safety of available
fish.19 20 Deriving human health criteria using an
unsuppressed FCR furthers the restoration goals of the CWA and ensures
protection of human health-related designated uses (as pollutant levels
decrease, fish habitats are restored, and fish availability increases
over time). See section III for additional discussion regarding use of
an unsuppressed FCR to protect a subsistence or sustenance fishing use,
especially where the subsistence or sustenance use is based in whole or
in part on tribal treaty or other reserved fishing rights.\21\
---------------------------------------------------------------------------
\18\ USEPA. 2000. Methodology for Deriving Ambient Water Quality
Criteria for the Protection of Human Health. U.S. Environmental
Protection Agency, Office of Water, Washington, DC EPA-822-B-00-004.
https://www.epa.gov/wqc/human-health-water-quality-criteria.
\19\ USEPA. January 2013. Human Health Ambient Water Quality
Criteria and Fish Consumption Rates: Frequently Asked Questions.
https://www.epa.gov/wqc/human-health-ambient-water-quality-criteria-and-fish-consumption-rates-frequently-asked.
\20\ National Environmental Justice Advisory Council, Fish
Consumption and Environmental Justice, p.44 (2002) available at
https://www.epa.gov/sites/production/files/2015-02/documents/fish-consump-report_1102.pdf.
\21\ The term ``subsistence'' is coterminous with ``sustenance''
in this context. Hereafter, the document uses the term
``subsistence.''
---------------------------------------------------------------------------
d. Relative Source Contribution
When deriving human health criteria for non-carcinogens and
nonlinear carcinogens, EPA recommends including a RSC factor to account
for sources of exposure other than drinking water and fish and
shellfish from inland and nearshore waters, so that the pollutant
effect threshold (i.e., RfD) is not apportioned to drinking water and
fish consumption alone. The rationale for this approach is that for
pollutants exhibiting threshold effects, the objective of the human
health criteria is to ensure that an individual's total exposure from
all sources does not exceed that threshold level. These other exposures
include exposure to a particular pollutant from ocean fish and
shellfish consumption (which is not included in EPA's default national
FCR), non-fish food consumption (e.g., fruits, vegetables, grains,
meats, poultry), dermal exposure, and inhalation exposure. EPA's
guidance includes a procedure for determining an appropriate RSC value
ranging from 0.2 to 0.8 for a given pollutant.
III. Derivation of Human Health Criteria for Washington
A. Scope of Pollutants and Waters Covered by This Final Rule
In 1992, EPA did not establish human health criteria in the NTR for
some priority toxic pollutants because, as stated in the preamble to
the final rule at 57 FR 60848, December 22, 1992, EPA had no 304(a)
recommendations for those pollutants at the time. EPA now has 304(a)
recommendations for 99 priority toxic pollutants listed pursuant to CWA
section 307(a)(1) (85 for which EPA established criteria in the NTR,
plus 14 additional pollutants).
After consideration of all comments received on EPA's proposed
rule, and EPA's CWA 303(c) action on Washington's submittal, EPA is
finalizing 144 new and revised Washington-specific criteria for
priority toxic pollutants in this rule. For arsenic, dioxin and
thallium, EPA is not revising Washington's existing criteria from the
NTR at this time, as explained below and in EPA's Response to Comments
document in the docket for the final rule. For those priority
pollutants for which EPA does not have 304(a) national recommended
criteria, and are therefore not included in Washington's submittal or
this final rule, EPA expects that Washington will continue to apply its
existing narrative toxics criterion in the state's WQS at WAC 173-201A-
260(2)(a).
Several commenters raised concerns about the scientific
defensibility of EPA's proposed human health criteria for arsenic, and
one commenter raised similar concerns about EPA's proposed criteria for
2,3,7,8-TCDD (dioxin). Additionally, after EPA proposed revised human
health criteria for thallium in Washington, EPA further evaluated the
scientific uncertainty around the appropriate RfD for thallium. EPA
carefully considered all of these comments and information regarding
these three pollutants, along with the comments that articulated it is
important for Washington to have protective numeric criteria in place
for priority toxic pollutants such as arsenic and dioxin. Given the
scientific uncertainty regarding aspects of the science upon which the
proposed human health criteria for arsenic, dioxin, and thallium were
based, EPA is withdrawing its proposal of revised criteria for these
three pollutants at this time and leaving the existing criteria from
the NTR in effect for CWA purposes.\22\ EPA did not update the 304(a)
national recommended criteria for these three pollutants in 2015. As
noted earlier, IRIS was the primary source of toxicity values (i.e.,
RfD and CSF) for EPA's 2015 updated 304(a) human health criteria. For
thallium, EPA's IRIS database does not currently contain an estimate of
thallium's toxicity (i.e., a RfD).\23\ For dioxin, IRIS does not
currently contain a measure of dioxin's cancer-causing ability (i.e., a
CSF).\24\ Without such values, EPA has concluded that further analysis
is necessary in order to promulgate scientifically sound revised
criteria for these two pollutants. For arsenic, there is uncertainty
surrounding the toxicological assessment with respect to human health
effects. EPA's current plan for addressing the arsenic issues is
described in the Assessment Development Plan for the Integrated Risk
Information System (IRIS) Toxicological Review of Inorganic Arsenic
(EPA/630/R-14/101, November 2015). EPA intends to reevaluate the
existing federal arsenic, dioxin and thallium human health criteria for
Washington by 2018, with particular consideration of any relevant
toxicity and bioaccumulation information.
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\22\ EPA is moving Washington's existing arsenic, dioxin and
thallium criteria from the NTR into 40 CFR 131.45 to have one
comprehensive human health criteria rule for Washington.
\23\ https://cfpub.epa.gov/ncea/iris/index.cfm?fuseaction=iris.showQuickView&substance_nmbr=1012.
\24\ https://cfpub.epa.gov/ncea/iris/index.cfm?fuseaction=iris.showQuickView&substance_nmbr=1024.
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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.
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A few commenters expressed concern that Washington would not have
the data or implementation guidance to properly implement a fish tissue
criterion for methylmercury, and requested that EPA leave the NTR total
mercury criteria in effect in Washington. The fish tissue methylmercury
criterion reflects EPA's 2000 Methodology, the best available science,
and supersedes all previous 304(a) human health mercury criteria
recommendations published by EPA (except for the waters of the Great
Lakes System), including the 304(a) recommended criteria that served as
the basis for the total mercury criteria that EPA promulgated for
Washington in the NTR. EPA recommends a fish tissue water quality
criterion for methylmercury for many reasons. A fish tissue water
quality criterion integrates spatial and temporal complexity that
occurs in aquatic systems and affects methylmercury bioaccumulation.
For this pollutant, a fish tissue criterion is more closely tied to the
goal of protecting human health because it is based directly on the
dominant human exposure route for methylmercury in the U.S., which is
consumption of fish and shellfish. The concentration of methylmercury
is also generally easier to quantify in fish tissue than in water and
is less variable in fish and shellfish tissue over the time periods in
which WQS are typically implemented in water quality-based controls,
such as NPDES permits. Finally, fish consumption advisories for mercury
are also based on the amount of methylmercury in fish tissue.\26\ While
the purpose of a fish advisory is different from the purpose of a water
quality criterion, it will be helpful to the public to have water
quality criteria and fish consumption advisories for methylmercury
expressed using the same terms. In response to comments regarding
implementation of the methylmercury criterion, in 2010, EPA published
the comprehensive Guidance for Implementing the January 2001
Methylmercury Water Quality Criterion (EPA 823-R-10-001), to aid states
in implementing the fish tissue-based methylmercury water quality
criterion. EPA is confident that Washington will be able to implement
the fish tissue criterion using the information contained in that
document, and EPA remains available to offer assistance in doing so.
Thus there is no need or requirement to leave the NTR total mercury
criteria in place in Washington.
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\26\ While both water quality criteria and fish consumption
advisories are designed ultimately to protect human health, they
represent very different values and goals. Water quality criteria
express or establish a desired condition and must protect the
designated use, such as subsistence fishing. Fish consumption
advisories start with existing levels of fish contamination
resulting from impaired water quality, and provide advice to
populations consuming such fish on limiting levels of consumption in
order to reduce risk from contamination.
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This final rule does not change or supersede any criteria that EPA
previously promulgated for other states in the NTR, nor does it change
any other elements of the NTR such as EPA's original basis for
promulgation. For clarity in organization, EPA is withdrawing
Washington from the NTR at 40 CFR 131.36 and incorporating the
Washington-specific criteria in this rule (as well as the existing NTR
criteria for arsenic, dioxin and thallium) into 40 CFR 131.45 so there
is a single comprehensive set of federally promulgated criteria for
Washington.
This rule applies to waters under the State of Washington's
jurisdiction, and not to waters within Indian country,\27\ unless
otherwise specified in federal law. Some waters located within Indian
country already have CWA-effective human health criteria, while others
do not.\28\ Several tribes are working with EPA to either revise their
existing CWA-effective WQS, or obtain treatment in a similar manner as
a state (TAS) status in order to adopt CWA-effective WQS in the near
future. EPA will continue to work closely with tribes in Washington to
ensure that they adopt human health criteria that are scientifically
supported and protective of designated uses, in accordance with the CWA
and EPA's regulations. In addition, on September 29, 2016, EPA
published an Advanced Notice of Proposed Rulemaking in the Federal
Register that seeks input on an approach that involves EPA promulgating
baseline WQS for reservations that currently have no CWA-effective WQS,
including such reservations within the State of Washington.\29\
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\27\ See 18 U.S.C. 1151 for the definition of Indian country.
\28\ Indian country waters with CWA-effective WQS include those
where (a) EPA has authorized a tribe to adopt WQS under the CWA for
its reservation and the tribe has adopted standards that EPA has
approved, and (b) EPA has promulgated federal WQS.
\29\ For more information, see: https://www.epa.gov/wqs-tech/advance-notice-proposed-rulemaking-federal-baseline-water-quality-standards-indian.
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B. Washington's Designated Uses and Tribal Reserved Fishing Rights
a. EPA's Consideration of Tribal Treaty Rights
Under the Supremacy Clause of the U.S. Constitution, federal
treaties have the same legal force as federal statutes.\30\ As such,
the provisions of federal statutes should generally be read in harmony
with treaties where they both apply. In certain instances, statutes may
contain provisions indicating that they must be read in harmony with
treaties. Such is the case with the CWA, which provides that the Act
``shall not be construed as . . . affecting or impairing the provisions
of any treaty of the United States.'' \31\
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\30\ U.S. Const. art. IV, Sec. 2: The ``Constitution . . . of
the United States . . . and all Treaties made, or which shall be
made, under the Authority of the United States, shall be the supreme
Law of the Land; and the Judges in every State shall be bound
thereby, any Thing in the Constitution or Laws of any State to the
Contrary notwithstanding.''
\31\ CWA Section 511, 33 U.S.C. 1371.
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In determining whether WQS satisfy the CWA and EPA's regulations,
and when setting criteria for the protection of human health, it is
necessary to consider other applicable laws, such as federal treaties
(e.g., U.S. Treaties with Indians). While treaties do not expand EPA's
authority, they are binding on the federal government. As a result, EPA
has an obligation to ensure that its actions do not conflict with
tribal treaty rights.\32\ For the foregoing reasons, and
[[Page 85423]]
as further explained below, it is therefore necessary and appropriate
to consider tribal treaties to ensure that EPA's actions under the CWA
are in harmony with such treaties. See also EPA's Response to Comment
document in the docket for this rule.
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\32\ U.S. Const. art. IV, Sec. 2; see United States v. Forty-
Three Gallons of Whiskey, 93 U.S. 188, 196 (1833) (recognizing that
``the Constitution declares a treaty to be the supreme law of the
land,'' and that ``a treaty is to be regarded . . . as equivalent to
an act of the legislature'') and Worcester v. Georgia, 31 U.S. 515,
594 (1832) (``So long as . . . treaties exist, having been formed
within the sphere of the federal powers, they must be respected and
enforced by the appropriate organs of the federal government.'').
See also EPA policies on considering treaty rights: Working
Effectively With Tribal Governments: Resource Guide at pp. 49-52, 53
(August 1998) (explaining the key principles underlying the
application of Indian treaty rights, and noting that ``[f]ederal,
state, and local agencies need to refrain from taking actions that
are not consistent with tribal rights wherever they exist'');
Commemorating the 30th Anniversary of the EPA's Indian Policy,
Memorandum from Gina McCarthy to All EPA Employees, p. 1 (December
1, 2014) (reiterating that ``EPA must ensure that its actions do not
conflict with tribal treaty rights'' and stating that ``EPA programs
should be implemented to enhance the protection of tribal treaty
rights and treaty-covered resources when we have the discretion to
do so''); EPA Policy for the Administration of Environmental
Programs on Indian Reservations (November 8, 1984) (known as ``EPA
1984 Indian Policy'').
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b. Treaty-Reserved Subsistence Fishing Rights in Washington
The majority of waters under the jurisdiction of the State of
Washington are subject to federal treaties with tribes.\33\ There are
eight Stevens-Palmer Treaties relevant to the State of Washington
through which 24 tribes reserved for themselves identical or nearly
identical fishing rights within the boundaries of present-day
Washington; specifically, the treaty-reserved ``right of taking fish at
usual and accustomed places, in common with all citizens of the
Territory.'' \34\ The right to take fish at usual and accustomed places
extends to lands formerly ceded by the tribes to the U.S. as described
in the treaties, as well as to all places beyond the boundaries of the
ceded territories that tribal members regularly used at treaty
time.\35\
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\33\ See https://wdfw.wa.gov/hunting/tribal/treaty_history.html.
\34\ See e.g. Treaty with the Yakima art. 3, June 9, 1855, 12
Stat. 951. In United States v. Winans, 198 U.S. 371 (1905), the
Supreme Court adopted a ``reservation of rights'' approach in
interpreting the Stevens Treaty with the Yakima Nation: ``the treaty
was not a grant of rights to the Indians, but a grant of rights from
them--a reservation of those not granted.'' Id. at 381. In contrast,
``off reservation fishing by other citizens and residents of the
state is not a right but merely a privilege which may be granted,
limited or withdrawn by the state as the interests of the state or
the exercise of treaty fishing rights may require.'' U.S. v
Washington, 384 F. Supp. 312, 332 (W.D. Wash. 1974) aff'd 520 F.2d
676 (9th Cir. 1975), cert. denied 423 U.S. 1086 (1976).
\35\ See Seufert Bros. Co. v. U.S., 249 U.S. 194, 199 (1919). In
U.S. v Washington, the court stated, citing Seufert Bros. Co.,
``every fishing location where members of a tribe customarily fished
from time to time at and before treaty times, however distant from
the then usual habitat of the tribe, and whether or not other tribes
then also fished in the same waters, is a usual and accustomed
ground or station at which the treaty tribe reserved, and its
members presently have, the right to take fish.'' 384 F. Supp. at
332.
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The parties to the treaties all recognized the importance of the
fishing right for the tribes' subsistence, ceremonial, as well as
commercial purposes.\36\ In U.S. v Washington, the district court made
detailed findings of facts regarding the reserved fishing right,
including the importance of subsistence fishing to the treaty tribes:
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\36\ For a thorough discussion on the treaty negotiation and
execution and meaning of the reserved fishing right, see e.g., U.S.
v Washington, 384 F. Supp. at 348-359 (containing finding of facts
regarding, inter alia, treaty status, pre-treaty role of fishing
among northwest Indians, treaty background, negotiation and
execution of the treaties, and post-treaty Indian fishing); see also
id. at 340 (``The right to fish for all species available in the
waters from which, for so many ages, their ancestors derived most of
their subsistence is the single most highly cherished interest and
concern of the present members of plaintiff tribes, with rare
exceptions even among tribal members who personally do not fish or
derive therefrom any substantial amount of their subsistence.'');
id. at 343 (``The evidence shows beyond doubt that at treaty time
the opportunity to take fish for personal subsistence and religious
ceremonies was the single matter of utmost concern to all treaty
tribes and their members.''); and U.S. v. Washington, No. 13-35474,
2016 U.S. App. LEXIS 11709, at *29 (9th Cir. June 27, 2016) (``The
Indians reasonably understood Governor Stevens to promise not only
that they would have access to their usual and accustomed fishing
places, but also that there would be fish sufficient to sustain
them.'').
At the treaty negotiations, a primary concern of the tribes,
whose way of life was so heavily dependent upon harvesting
anadromous fish, was that they have freedom to move about to gather
food, particularly salmon, . . . at their usual and accustomed
fishing places. . . . Subsequent to the execution of the treaties
and in reliance thereon, the members of the [treaty tribes with
reserved fishing rights in Washington] have continued to fish for
subsistence, sport, and commercial purposes at their usual and
accustomed places. Such fishing provided and still provides an
important part of their livelihood, subsistence and cultural
identity. The Indian cultural identification with fishing is
primarily dietary, related to the subsistence fishery, and
secondarily associated with religious ceremonies and commercial
fishing.\37\
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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).
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\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.'').
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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\
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\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:
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\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
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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.
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\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.
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\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 https://www.doh.wa.gov/CommunityandEnvironment/Food/Fish/Advisories.
\53\ Heritage rates refer to the rates of fish intake consistent
with traditional tribal practices, prior to contact with European
settlers.
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The Washington tribes have generally agreed that 175 g/day is
acceptable for deriving protective criteria at this time, when
accompanied by other protective input parameters to calculate the
criteria. However, EPA recognizes that some tribes have raised concerns
as to whether a FCR of 175 g/day reasonably reflects current
unsuppressed consumption rates of tribes within the State of
Washington, based on the best currently available information. A FCR of
175 g/day approximates the 95th percentile consumption rate of surveyed
tribal members from the CRITFC study \54\ and includes anadromous fish,
which is reasonable given that these marine species reside in
Washington's nearshore (i.e., within three miles of the coast) waters,
especially Puget Sound, and accumulate pollutants discharged to these
waters during a significant portion of their lives. The CRITFC survey
also includes four tribes (three of which have treaty-reserved rights
in Washington, the most of any one contemporary FCR survey in
Washington) along the Columbia River in Washington, Idaho, and Oregon.
Given this, and also considering the variability in heritage and
contemporary FCRs and the uncertainty regarding suppression effects on
current FCRs, the CRITFC survey provides scientifically sound estimates
of fish consumption for the purpose of deriving a Washington statewide
FCR for the tribal target general population.
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\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).
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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.
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\55\ EPA's 2000 Methodology, pages 2-6.
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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.
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\56\ https://nepis.epa.gov/Exe/ZyPDF.cgi/P100LIJF.PDF?Dockey=P100LIJF.PDF.
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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.
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\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.
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\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.
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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\
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\60\ https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=20003IEI.txt See
also: National Primary Drinking Water Regulations-Synthetic Organic
Chemicals and Inorganic Chemicals; National Primary Drinking Water
Regulations Implementation, 57 FR 31776, July 17, 1992.
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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.
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\61\ Final Updated Ambient Water Quality Criteria for the
Protection of Human Health, (80 FR 36986, June 29, 2015). See also:
USEPA. 2015. Final 2015 Updated National Recommended Human Health
Criteria. U.S. Environmental Protection Agency, Office of Water,
Washington, DC https://www.epa.gov/wqc/human-health-water-quality-criteria.
\62\ USEPA Region 10. August 2007. Framework for Selecting and
Using Tribal Fish and Shellfish Consumption Rates for Risk-Based
Decision Making at CERCLA and RCRA Cleanup Sites in Puget Sound and
the Strait of Georgia. Appendix B. https://yosemite.epa.gov/r10/
CLEANUP.NSF/7780249be8f251538825650f0070bd8b/
e12918970debc8e488256da6005c428e/$FILE/
Tribal%20Shellfish%20Framework.pdf.
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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.
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\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.
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\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.
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\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).
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Under the CWA, Congress gave states primary responsibility for
developing and adopting WQS for their navigable waters (CWA section
303(a)-(c)). Although EPA revises and establishes new human health
criteria for Washington in this final rule, Washington continues to
have the option to adopt and submit to EPA human health criteria for
the pollutants in this final rule, consistent with CWA section 303(c)
and EPA's implementing regulations at 40 CFR part 131.
In its September 14, 2015 proposed rule, EPA proposed that if
Washington adopted and submitted human health criteria, and EPA
approved those criteria before finalizing its federal rule, EPA would
not proceed with finalizing those criteria and Washington's approved
criteria would be solely applicable for CWA purposes. EPA did not
receive any comments opposing this provision, thus EPA is proceeding
with such an approach. In this final rule, EPA is withdrawing
Washington from the NTR at 40 CFR 131.36, and, with the exception of
criteria for which EPA has approved Washington's criteria, EPA is
incorporating the Washington-specific criteria in this rule (as well as
the existing NTR criteria for arsenic, dioxin
[[Page 85432]]
and thallium) into 40 CFR 131.45 so there is a single comprehensive set
of federally promulgated criteria for Washington. Therefore, the CWA-
effective numeric human health criteria in Washington consist of the
federally promulgated criteria at 40 CFR 131.45 and those criteria that
EPA approved at WAC 173-201A-240 in Washington's August 1, 2016
submittal.
Additionally, in its September 14, 2015 proposed rule, EPA proposed
that if Washington adopted and submitted human health criteria after
EPA finalized its rule, once EPA approved Washington's WQS, the
pollutant-specific or site-specific EPA-approved criteria in
Washington's WQS would become the solely effective criteria for CWA
purposes and EPA's promulgated criteria for those pollutants or for
that site would no longer apply. A few commenters supported this
provision, where Washington's criteria for specific pollutants or sites
become the only CWA-effective criteria upon EPA's approval, without any
delay caused by EPA's withdrawal of the corresponding federal criteria.
A few other commenters did not support this provision, and asked that
EPA either delete the provision, or make clear that criteria adopted by
the state would have to be at least as stringent as the federal
criteria for EPA to approve and make the state criteria effective for
CWA purposes. Upon further consideration of comments received on its
proposed rule, EPA decided not to finalize this provision. Pursuant to
40 CFR 131.21(c), EPA's federally promulgated WQS are and will be
applicable for purposes of the CWA until EPA withdraws those federally
promulgated WQS. EPA would undertake such a rulemaking to withdraw the
federal criteria if and when Washington adopts and EPA approves
corresponding criteria that meet the requirements of section 303(c) of
the CWA and EPA's implementing regulations at 40 CFR part 131.
F. Alternative Regulatory Approaches and Implementation Mechanisms
Washington has considerable discretion to implement these revised
and new federal human health criteria through various water quality
control programs including the NPDES program, which limits discharges
to waters except in compliance with a NPDES permit. EPA's regulations
at 40 CFR 131.14 authorize states and authorized tribes to adopt WQS
variances to provide time to achieve the applicable WQS. 40 CFR part
131 defines WQS variances at 131.3(o) as time-limited designated uses
and supporting criteria for a specific pollutant(s) or water quality
parameter(s) that reflect the highest attainable conditions during the
term of the WQS variances. WQS variances adopted in accordance with 40
CFR part 131 allow states and authorized tribes to address water
quality challenges in a transparent and predictable way. Variances help
states and authorized tribes focus on making incremental progress in
improving water quality, rather than pursuing a downgrade of the
underlying water quality goals through a designated use change, when
the designated use is not attainable throughout the term of the
variance due to one of the factors listed in 40 CFR 131.14. EPA's
regulations at 40 CFR 122.47 provide the requirements when states and
authorized tribes wish to include permit compliance schedules in their
NPDES permits if dischargers need additional time to meet their water
quality-based limits based on the applicable WQS. EPA's updated
regulations at 40 CFR 131.15 require any state or authorized tribe
wishing to use permit compliance schedules to also include provisions
authorizing the use of permit compliance schedules after appropriate
public involvement to ensure that a decision to allow permit compliance
schedules derives from and complies with the applicable WQS. (80 FR
51022, August 21, 2015).
40 CFR 131.10 specifies how states and authorized tribes establish,
modify or remove designated uses for their waters. 40 CFR 131.11
specifies the requirements for establishing criteria to protect
designated uses, including criteria modified to reflect site-specific
conditions. In the context of this rulemaking, a site-specific
criterion (SSC) is an alternative value to the federal human health
criteria that could be applied on a watershed, area-wide, or waterbody-
specific basis that meets the regulatory test of protecting the
designated use, being scientifically defensible, and ensuring the
protection and maintenance of downstream WQS. A SSC may be more or less
stringent than the otherwise applicable federal criterion. A SSC may be
appropriate when further scientific data and analyses can bring added
precision to express the concentration of a particular pollutant that
protects the human health-related designated use in a particular
waterbody.
A few commenters supported EPA's acknowledgement of the
flexibilities that Washington has available when implementing the final
criteria in this rule, while others commented that these tools allow
Washington to delay or avoid implementing the criteria. EPA did not
propose to change, nor does this final rule change, any of the
flexibilities already afforded to Washington by EPA's regulations to
modify or remove designated uses, adopt variances, issue compliance
schedules, or establish site-specific criteria. These implementation
tools are important for making incremental progress and allowing the
time for adaptive management when designated uses and associated
criteria are difficult to attain. Washington may continue to use any of
these regulatory flexibilities when implementing the final federal
human health criteria.
a. Designating Uses
EPA's final human health criteria apply to waters that Washington
has designated for the following: Fresh waters--Harvesting (fish
harvesting), Domestic Water (domestic water supply), and Recreational
Uses; Marine waters--Shellfish Harvesting (shellfish--clam, oyster, and
mussel--harvesting), Harvesting (salmonid and other fish harvesting,
and crustacean and other shellfish--crabs, shrimp, scallops, etc.--
harvesting), and Recreational Uses (see WAC 173-201A-600 and WAC 173-
201A-610). If Washington removes the Domestic Water use but retains any
of the other above designated uses for any particular waterbody
affected by this final rule, and EPA finds that removal to be
consistent with CWA section 303(c) and EPA's implementing regulations
at 40 CFR part 131, then the federal organism-only criteria will apply
in place of the federal water-plus-organism criteria. If Washington
removes designated uses such that none of the above uses apply to any
particular waterbody affected by this final rule and adopts the highest
attainable use, as defined by 40 CFR 131.3(m), consistent with 40 CFR
131.10(g), and EPA finds that removal to be consistent with CWA section
303(c) and EPA's implementing regulations at 40 CFR part 131, then the
federal human health criteria will no longer apply to that waterbody.
Instead, any criteria associated with the newly designated highest
attainable use would apply to that waterbody.
b. Variances and Compliance Schedules
EPA's final human health criteria apply to use designations that
Washington has already established. Concurrent with this final rule,
EPA approved revisions to Washington's variance and compliance schedule
authorizing provisions. Washington may use its EPA-approved variance
procedures (see WAC 173-201A-420) to establish time-limited designated
uses and criteria to apply for the purposes specified in 40 CFR 131.14
as it pertains
[[Page 85433]]
to federal criteria when adopting such variances. Washington has
sufficient authority to use variances when implementing the human
health criteria as long as such variances are adopted consistent with
40 CFR 131.14, and submitted to EPA for review under CWA section
303(c). Similarly, Washington may use its EPA-approved regulation
authorizing the use of permit compliance schedules (see WAC 173-201A-
510(4)), consistent with 40 CFR 131.15, to grant compliance schedules,
as appropriate, for WQBELs based on the federal criteria. These state
regulations are not affected by this final rule.
c. Site-Specific Criteria
As discussed in section III.E, if Washington adopts and EPA
approves site-specific criteria that fully meet the requirements of
section 303(c) of the CWA and EPA's implementing regulations at 40 CFR
part 131, EPA will undertake a rulemaking to withdraw the corresponding
federal criteria.
IV. Economic Analysis
Under the CWA, water quality criteria are set on the basis of the
latest scientific knowledge. EPA is not required under the CWA nor
obligated under Executive Orders 12866 and 13563 to conduct an economic
analysis of the criteria. Costs cannot be considered in establishing
water quality criteria as part of WQS. Nonetheless, EPA conducted a
cost analysis for the criteria in this final rule for the purpose of
transparency and presents this information reflecting the potential
economic effects of the rule.
These WQS may serve as a basis for development of NPDES permit
limits. Washington has NPDES permitting authority, and retains
considerable discretion in implementing standards. EPA evaluated the
potential costs to NPDES dischargers associated with state
implementation of EPA's final criteria. This analysis is documented in
Final Economic Analysis for the Revision of Certain Federal Water
Quality Criteria Applicable to Washington, which can be found in the
record for this rulemaking.
Any NPDES-permitted facility that discharges pollutants for which
the revised human health criteria are more stringent than the
applicable aquatic life criteria (or for which human health criteria
are the only applicable criteria) could potentially incur compliance
costs. The types of affected facilities could include industrial
facilities and POTWs discharging wastewater to surface waters (i.e.,
point sources). EPA did not attribute compliance with water quality-
based effluent limitations (WQBELs) reflective of existing federal
human health criteria applicable to Washington (hereafter referred to
as ``baseline criteria'') to the final rule. Once in compliance with
WQBELs reflective of baseline criteria, EPA expects that dischargers
will continue to use the same types of controls to come into compliance
with the revised criteria; EPA did not fully evaluate the potential for
costs to nonpoint sources,\69\ such as agricultural runoff, that could
be incurred under a TMDL for this analysis, but did analyze the
administrative costs to the state of preparing TMDLs for potentially
incrementally impaired waters. Actual costs of implementation of TMDLs
is beyond the scope of this analysis.
---------------------------------------------------------------------------
\69\ The CWA does not regulate nonpoint sources. However, EPA
recognizes that the state may require controls for nonpoint sources
as part of potential incremental TMDLs. It is difficult to model and
evaluate the potential cost impacts of this final rule to nonpoint
sources because they are intermittent, variable, and occur under
hydrologic or climatic conditions associated with precipitation
events. Also, data on instream and discharge levels of the
pollutants of concern after dischargers have implemented controls to
meet current WQS, total maximum daily loads (TMDLs) for impaired
waters, or other water quality improvement plans, are not available.
Therefore, trying to determine which sources would not achieve WQS
based on the revised human health criteria after complying with
existing regulations and policies may not be possible. In addition,
legacy contamination (e.g., in sediment) may be a source of ongoing
loading. Atmospheric deposition may also contribute loadings of the
pollutants of concern (e.g., mercury). EPA did not estimate sediment
remediation costs, or air pollution controls costs, for this
analysis because EPA did not have data on the contribution of these
sources, and because control costs for deposition may be covered by
Clean Air Act rules.
---------------------------------------------------------------------------
A. Identifying Affected Entities
EPA identified 406 point source facilities that could ultimately be
affected by this final rule. Of these potentially affected facilities,
73 are major dischargers and 333 are minor dischargers. EPA did not
include general permit facilities in its analysis because data for such
facilities are limited, and flows are usually negligible. Of the
potentially affected facilities, EPA evaluated a sample of 17 major
facilities. Minor facilities are unlikely to incur costs as a result of
implementation of the rule, because minor facilities are typically
those that do not discharge toxics in toxic amounts and discharge less
than 1 million gallons per day (mgd). Although lower human health
criteria could potentially change this categorization, EPA did not have
effluent data on toxic pollutants to evaluate minor facilities for this
analysis. Table 2 summarizes these potentially affected facilities by
type and category.
Table 2--Potentially Affected Facilities
----------------------------------------------------------------------------------------------------------------
Category Minor Major All
----------------------------------------------------------------------------------------------------------------
Municipal....................................................... 184 48 232
Industrial...................................................... 149 25 174
-----------------------------------------------
Total....................................................... 333 73 406
----------------------------------------------------------------------------------------------------------------
B. Method for Estimating Costs
EPA evaluated the two major municipal facilities with design flows
greater than 100 mgd and a large industrial refinery, to attempt to
capture the facilities with the potential for the largest costs. For
the remaining major facilities, EPA evaluated a random sample of
facilities to represent discharger type and category. For all sample
facilities, EPA evaluated existing baseline permit conditions,
reasonable potential to exceed human health criteria based on the final
rule, and potential to exceed projected effluent limitations based on
the last three years of effluent monitoring data (if available). In
instances of exceedances of projected effluent limitations under the
final criteria, EPA determined the likely compliance scenarios and
costs. Only compliance actions and costs that would be needed above the
baseline level of controls are attributable to the final rule.
EPA assumed that dischargers will pursue the least cost means of
compliance with WQBELs. Incremental compliance actions attributable to
the final rule may include pollution prevention, end-of-pipe treatment,
and alternative compliance mechanisms (e.g., variances). EPA annualized
one-
[[Page 85434]]
time costs (capital costs and variance costs) over 20 years using a 3
percent discount rate to obtain total annual costs per facility. For
the random sample, EPA extrapolated the annualized costs based on the
sampling weight for each sample facility. To obtain an estimate of
total costs to point sources, EPA added the results for the certainty
sample to the extrapolated random sample costs.
C. Results
Based on the results for 17 sample facilities across 8 industrial
and municipal categories,\70\ EPA estimated a total annual compliance
cost of approximately $126,000 to $150,000 for all major dischargers in
the state (using a 3 percent discount rate). Only five facilities are
estimated to incur pollution prevention program costs, while two
facilities are expected to also incur costs of obtaining a variance.
Most of the facilities would not bear any cost. The low end of the
range reflects the assumption that the compliance actions (e.g.,
pollution prevention) will result in compliance with projected effluent
limits, whereas the high scenario reflects projected effluent limits
not being met, and thus includes the estimated administrative cost of
also obtaining a variance. All compliance costs are for industrial
facilities, and are attributable to the human health criterion for
methylmercury.
---------------------------------------------------------------------------
\70\ Seven industrial categories (mining, food and kindred
products, paper and allied products, chemicals and allied products,
petroleum refining and related industries, primary metal industries,
and transportation and public utilities (except POTWs)) and
municipal POTWs.
---------------------------------------------------------------------------
If the revised criteria result in an incremental increase in
impaired waters, resulting in the need for TMDL development, there
could also be some costs to nonpoint sources of pollution. Using
available ambient monitoring data, EPA compared pollutant
concentrations to the baseline and final criteria, identifying
waterbodies that may be incrementally impaired (i.e., impaired under
the final criteria but not under the baseline). For the parameters and
stations for which EPA had sufficient monitoring data available to
evaluate, there were 50 impairments under the baseline criteria and 124
under the final criteria, for a total of 74 potential incremental
impairments (or a 148 percent increase relative to the baseline;
including for methylmercury, PCBs, and DDT). This increase indicates
the potential for nonpoint sources to bear some compliance costs,
although data are not available to estimate the magnitude of these
costs. The control of nonpoint sources such as in the context of a TMDL
could result in different requirements, and thus different costs, for
point sources.
If the net increase in potential impairments is any indication of
the potential increase in the number of TMDLs, then the total
administrative costs for TMDL development could be in the range of $2.7
million to $3.0 million based on national average single-cause single-
waterbody TMDL development costs from U.S. EPA (2001; updated to 2014
dollars). However, these costs may be reduced if Ecology develops
multi-cause or multi-waterbody TMDLs. If these costs are spread over 8
to 15 years, at a discount rate of 3 percent, the annualized costs of
developing TMDLs are $229,000 to $422,000.
Combining the potential facility compliance costs and TMDL
administrative costs results in total annual costs of $355,000 to
$572,000, at a 3 percent discount rate.
V. Statutory and Executive Order Reviews
A. Executive Order 12866 (Regulatory Planning and Review) and Executive
Order 13563 (Improving Regulation and Regulatory Review)
It has been determined that this final rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 (58 FR
51735, October 4, 1993) and is, therefore, not subject to review under
Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). The
final rule does not establish any requirements directly applicable to
regulated entities or other sources of toxic pollutants. However, these
WQS may serve as a basis for development of NPDES permit limits.
Washington has NPDES permitting authority, and retains considerable
discretion in implementing standards. In the spirit of Executive Order
12866, EPA evaluated the potential costs to NPDES dischargers
associated with state implementation of EPA's final criteria. This
analysis, Final Economic Analysis for the Revision of Certain Federal
Water Quality Criteria Applicable to Washington, is summarized in
section IV of the preamble and is available in the docket.
B. Paperwork Reduction Act
This action does not impose any direct new information collection
burden under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq. Actions to implement these WQS could entail additional
paperwork burden. Burden is defined at 5 CFR 1320.3(b). This action
does not include any information collection, reporting, or record-
keeping requirements.
C. Regulatory Flexibility Act
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities. EPA has the
authority to promulgate WQS in any case where the Administrator
determines that a new or revised standard is necessary to meet the
requirements of the CWA. EPA-promulgated standards are implemented
through various water quality control programs including the NPDES
program, which limits discharges to navigable waters except in
compliance with an NPDES permit. The CWA requires that all NPDES
permits include any limits on discharges that are necessary to meet
applicable WQS. Thus, under the CWA, EPA's promulgation of WQS
establishes standards that the state implements through the NPDES
permit process. The state has discretion in developing discharge
limits, as needed to meet the standards. As a result of this action,
the State of Washington will need to ensure that permits it issues
include any limitations on discharges necessary to comply with the
standards established in the final rule. In doing so, the state will
have a number of choices associated with permit writing. While
Washington's implementation of the rule may ultimately result in new or
revised permit conditions for some dischargers, including small
entities, EPA's action, by itself, does not impose any of these
requirements on small entities; that is, these requirements are not
self-implementing.
D. Unfunded Mandates Reform Act
This action contains no federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local, or tribal governments or the private
sector. As these water quality criteria are not self-implementing,
EPA's action imposes no enforceable duty on any state, local or tribal
governments or the private sector. Therefore, this action is not
subject to the requirements of sections 202 or 205 of UMRA.
This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that could
significantly or uniquely affect small governments.
E. Executive Order 13132 (Federalism)
This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national
[[Page 85435]]
government and the states, or on the distribution of power and
responsibilities among the various levels of government. This rule does
not alter Washington's considerable discretion in implementing these
WQS, nor will it preclude Washington from adopting WQS in the future
that EPA concludes meet the requirements of the CWA, which will
eliminate the need for federal standards. Thus, Executive Order 13132
does not apply to this action.
F. Executive Order 13175 (Consultation and Coordination With Indian
Tribal Governments)
This action has tribal implications. However, it will neither
impose substantial direct compliance costs on federally recognized
tribal governments, nor preempt tribal law. In the State of Washington,
there are 29 federally recognized Indian tribes. To date, nine of these
Indian tribes have been approved for TAS for CWA sections 303 and
401.\71\ Of these nine tribes, seven have EPA-approved WQS in their
respective jurisdictions.\72\ This rule could affect federally
recognized Indian tribes in Washington because the numeric criteria for
Washington will apply to waters adjacent to (or upstream or downstream
of) the tribal waters, where many of those tribes have treaty rights to
take fish for their subsistence. Additionally, there are ten federally
recognized Indian tribes in the Columbia River Basin located in the
states of Oregon and Idaho that this rule could impact because their
waters could affect or be affected by the water quality of Washington's
downstream or upstream waters.
---------------------------------------------------------------------------
\71\ https://water.epa.gov/scitech/swguidance/standards/wqslibrary/approvtable.cfm.
\72\ https://yosemite.epa.gov/r10/water.nsf/34090d07b77d50bd88256b79006529e8/dd2a4df00fd7ae1a88256e0500680e86!OpenDocument. Note that this number
does not include the Confederated Tribes of the Colville
Reservation, which has federally promulgated WQS from 1989. EPA is
currently reviewing the Colville Tribe's application for TAS.
---------------------------------------------------------------------------
EPA consulted with federally recognized tribal officials under
EPA's Policy on Consultation and Coordination with Indian Tribes early
in the process of developing this rule to permit them to have
meaningful and timely input into its development. In February and March
2015, EPA held tribes-only technical staff and leadership consultation
sessions to hear their views and answer questions of all interested
tribes on the proposed rule. Representatives from approximately 23
tribes and four tribal consortia participated in two leadership
meetings held in March 2015. EPA and tribes have also met regularly
since November 2012 to discuss Washington's human health criteria at
both the tribal leadership level and technical staff level. The tribes
have repeatedly asked EPA to promulgate federal human health criteria
for Washington if the state did not do so in a timely and protective
manner. At these meetings, the tribes consistently emphasized that the
human health criteria should be derived using at least a minimum FCR
value of 175 g/day, a cancer risk level of 10-6, and the
latest scientific information from EPA's 304(a) recommended criteria.
EPA considered the input received during consultation with tribes when
developing this final rule (see section III for additional discussion
of how EPA considered tribal input).
In subsequent coordination with tribes, EPA received a letter on
August 5, 2016, from the Northwest Indian Fisheries Commission
disagreeing with EPA's potential adjustments to the RSC from the
proposed rule issued on September 14, 2015 to the final rule as a
result of public comments. The tribes expressed concern that less
stringent human health criteria as a result of the RSC adjustment would
result in lower protection of designated uses and limit the ability to
exercise tribal treaty rights, especially in light of a FCR that
underestimates tribal consumption. EPA considered this information
carefully before finalizing this rule, but for the reasons stated
above, decided to adjust the RSC to account for inclusion of some
marine fish in the FCR. This results in protective criteria that
account for other routes of exposure in addition to drinking water and
fish and shellfish from inland and nearshore waters and is consistent
with EPA's guidance.
G. Executive Order 13045 (Protection of Children From Environmental
Health and Safety Risks)
This rule is not subject to Executive Order 13045, because it is
not economically significant as defined in Executive Order 12866, and
because the environmental health or safety risks addressed by this
action do not present a disproportionate risk to children.
H. Executive Order 13211 (Actions That Significantly Affect Energy
Supply, Distribution, or Use)
This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy.
I. National Technology Transfer and Advancement Act of 1995
This final rulemaking does not involve technical standards.
J. Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations)
This action will not have disproportionately high and adverse human
health or environmental effects on minority or low-income populations.
Conversely, this action identifies and ameliorates disproportionately
high and adverse human health effects on minority populations and low-
income populations in Washington. EPA developed the human health
criteria included in this final rule specifically to protect
Washington's designated uses, using the most current science, including
local and regional information on fish consumption. Applying these
criteria to waters in the State of Washington will afford a greater
level of protection to both human health and the environment.
K. Congressional Review Act (CRA)
This action is subject to the CRA, and EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 131
Environmental protection, Indians-lands, Intergovernmental
relations, Reporting and recordkeeping requirements, Water pollution
control.
Dated: November 15, 2016.
Gina McCarthy,
Administrator.
For the reasons set forth in the preamble, EPA amends 40 CFR part
131 as follows:
PART 131--WATER QUALITY STANDARDS
0
1. The authority citation for part 131 continues to read as follows:
Authority: 33 U.S.C. 1251 et seq.
Subpart D--Federally Promulgated Water Quality Standards
Sec. 131.36 [Amended]
0
2. In Sec. 131.36, remove paragraph (d)(14).
0
3. Add Sec. 131.45 to read as follows:
Sec. 131.45 Revision of certain Federal water quality criteria
applicable to Washington.
(a) Scope. This section promulgates human health criteria for
priority toxic
[[Page 85436]]
pollutants in surface waters in Washington.
(b) Criteria for priority toxic pollutants in Washington. The
applicable human health criteria are shown in Table 1.
Table 1--Human Health Criteria for Washington
--------------------------------------------------------------------------------------------------------------------------------------------------------
A B C
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cancer slope Relative Reference Bio- Water &
factor, CSF source dose, RfD Bio-accumulation concentration organisms Organisms only
Chemical CAS No. (per mg/ contribution, (mg/ factor (L/kg factor (L/kg ([micro]g/ ([micro]g/L)
kg[middot]d) RSC (-) kg[middot]d) tissue) tissue) L)
......... (B1) (B2) (B3) (B4) (B5) (C1) (C2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. 1,1,1-Trichloroethane.......... 71556 ............ 0.50 2 10 ................ 20,000 50,000
2. 1,1,2,2-Tetrachloroethane...... 79345 0.2 - ............ 8.4 ................ 0.1 0.3
3. 1,1,2-Trichloroethane.......... 79005 0.057 - ............ 8.9 ................ 0.35 0.90
4. 1,1-Dichloroethylene........... 75354 ............ 0.50 0.05 2.6 ................ 700 4,000
5. 1,2,4-Trichlorobenzene......... 120821 0.029 - ............ 430 ................ 0.036 0.037
6. 1,2-Dichlorobenzene............ 95501 ............ 0.50 0.3 82 ................ 700 800
7. 1,2-Dichloroethane............. 107062 0.0033 - ............ 1.9 ................ 8.9 73
8. 1,2-Dichloropropane............ 78875 ............ - ............ ................ ................ .......... ..............
9. 1,2-Diphenylhydrazine.......... 122667 0.8 - ............ 27 ................ 0.01 0.02
10. 1,2-Trans-Dichloroethylene.... 156605 ............ 0.50 0.02 4.7 ................ 200 1,000
11. 1,3-Dichlorobenzene........... 541731 ............ 0.50 0.002 190 ................ 2 2
12. 1,3-Dichloropropene........... 542756 0.122 - ............ 3.0 ................ 0.22 1.2
13. 1,4-Dichlorobenzene........... 106467 ............ 0.50 0.07 84 ................ 200 200
14. 2,3,7,8-TCDD (Dioxin) **...... 1746016 156,000 - ............ ................ 5,000 1.3E-08 1.4E-08
15. 2,4,6-Trichlorophenol......... 88062 ............ - ............ ................ ................ .......... ..............
16. 2,4-Dichlorophenol............ 120832 ............ 0.50 0.003 48 ................ 10 10
17. 2,4-Dimethylphenol............ 105679 ............ - ............ ................ ................ .......... ..............
18. 2,4-Dinitrophenol............. 51285 ............ 0.50 0.002 4.4 ................ 30 100
19. 2,4-Dinitrotoluene............ 121142 ............ - ............ ................ ................ .......... ..............
20. 2-Chloronaphthalene........... 91587 ............ 0.80 0.08 240 ................ 100 100
21. 2-Chlorophenol................ 95578 ............ - ............ ................ ................ .......... ..............
22. 2-Methyl-4,6-Dinitrophenol.... 534521 ............ 0.50 0.0003 10 ................ 3 7
23. 3,3'-Dichlorobenzidine........ 91941 ............ - ............ ................ ................ .......... ..............
24. 3-Methyl-4-Chlorophenol....... 59507 ............ - ............ ................ ................ .......... ..............
25. 4,4'-DDD...................... 72548 0.24 - ............ 240,000 ................ 7.9E-06 7.9E-06
26. 4,4'-DDE...................... 72559 0.167 - ............ 3,100,000 ................ 8.8E-07 8.8E-07
27. 4,4'-DDT...................... 50293 0.34 - ............ 1,100,000 ................ 1.2E-06 1.2E-06
28. Acenaphthene.................. 83329 ............ 0.50 0.06 510 ................ 30 30
29. Acrolein...................... 107028 ............ - ............ ................ ................ .......... ..............
30. Acrylonitrile................. 107131 ............ - ............ ................ ................ .......... ..............
31. Aldrin........................ 309002 17 - ............ 650,000 ................ 4.1E-08 4.1E-08
32. alpha-BHC..................... 319846 6.3 - ............ 1,500 ................ 4.8E-05 4.8E-05
33. alpha-Endosulfan.............. 959988 ............ 0.50 0.006 200 ................ 6 7
34. Anthracene.................... 120127 ............ 0.50 0.3 610 ................ 100 100
35. Antimony...................... 7440360 ............ 0.50 0.0004 ................ 1 6 90
36. Arsenic **.................... 7440382 1.75 - ............ ................ 44 \a\ 0.018 \a\ 0.14
37. Asbestos...................... 1332214 ............ - ............ ................ ................ .......... ..............
38. Benzene....................... 71432 ............ - ............ ................ ................ .......... ..............
39. Benzidine..................... 92875 ............ - ............ ................ ................ .......... ..............
40. Benzo(a) Anthracene........... 56553 0.73 - ............ 3,900 ................ 0.00016 0.00016
41. Benzo(a) Pyrene............... 50328 7.3 - ............ 3,900 ................ 1.6E-05 1.6E-05
42. Benzo(b) Fluoranthene......... 205992 0.73 - ............ 3,900 ................ 0.00016 0.00016
43. Benzo(k) Fluoranthene......... 207089 0.073 - ............ 3,900 ................ 0.0016 0.0016
44. beta-BHC...................... 319857 1.8 - ............ 180 ................ 0.0013 0.0014
45. beta-Endosulfan............... 33213659 ............ - ............ ................ ................ .......... ..............
46. Bis(2-Chloroethyl) Ether...... 111444 ............ - ............ ................ ................ .......... ..............
47. Bis(2-Chloro-1-Methylethyl) 108601 ............ 0.50 0.04 10 ................ 400 900
Ether *..........................
48. Bis(2-Ethylhexyl) Phthalate... 117817 0.014 - ............ 710 ................ 0.045 0.046
49. Bromoform..................... 75252 0.0045 - ............ 8.5 ................ 4.6 12
50. Butylbenzyl Phthalate......... 85687 0.0019 - ............ 19,000 ................ 0.013 0.013
51. Carbon Tetrachloride.......... 56235 ............ - ............ ................ ................ .......... ..............
52. Chlordane..................... 57749 0.35 - ............ 60,000 ................ 2.2E-05 2.2E-05
53. Chlorobenzene................. 108907 ............ 0.50 0.02 22 ................ 100 200
54. Chlorodibromomethane.......... 124481 0.04 - ............ 5.3 ................ 0.60 2.2
55. Chloroform.................... 67663 ............ 0.50 0.01 3.8 ................ 100 600
56. Chrysene...................... 218019 0.0073 - ............ 3,900 ................ 0.016 0.016
57. Copper........................ 7440508 ............ - ............ ................ ................ .......... ..............
58. Cyanide....................... 57125 ............ 0.50 0.0006 ................ 1 9 100
59. Dibenzo(a,h) Anthracene....... 53703 7.3 - ............ 3,900 ................ 1.6E-05 1.6E-05
60. Dichlorobromomethane.......... 75274 0.034 - ............ 4.8 ................ 0.73 2.8
61. Dieldrin...................... 60571 16 - ............ 410,000 ................ 7.0E-08 7.0E-08
62. Diethyl Phthalate............. 84662 ............ 0.50 0.8 920 ................ 200 200
63. Dimethyl Phthalate............ 131113 ............ 0.50 10 4,000 ................ 600 600
64. Di-n-Butyl Phthalate.......... 84742 ............ 0.50 0.1 2,900 ................ 8 8
65. Endosulfan Sulfate............ 1031078 ............ 0.50 0.006 140 ................ 9 ..............
66. Endrin........................ 72208 ............ 0.80 0.0003 46,000 ................ 0.002 0.002
67. Endrin Aldehyde............... 7421934 ............ - ............ ................ ................ .......... ..............
68. Ethylbenzene.................. 100414 ............ 0.50 0.022 160 ................ 29 31
69. Fluoranthene.................. 206440 ............ 0.50 0.04 1,500 ................ 6 6
70. Fluorene...................... 86737 ............ 0.50 0.04 710 ................ 10 10
71. gamma-BHC; Lindane............ 58899 ............ 0.50 0.0047 2,500 ................ 0.43 0.43
[[Page 85437]]
72. Heptachlor.................... 76448 4.1 - ............ 330,000 ................ 3.4E-07 3.4E-07
73. Heptachlor Epoxide............ 1024573 5.5 - ............ 35,000 ................ 2.4E-06 2.4E-06
74. Hexachlorobenzene............. 118741 1.02 - ............ 90,000 ................ 5.0E-06 5.0E-06
75. Hexachlorobutadiene........... 87683 0.04 - ............ 1,100 ................ 0.01 0.01
76. Hexachlorocyclopentadiene..... 77474 ............ 0.50 0.006 1,300 ................ 1 1
77. Hexachloroethane.............. 67721 0.04 - ............ 600 ................ 0.02 0.02
78. Indeno(1,2,3-cd) Pyrene....... 193395 0.73 - ............ 3,900 ................ 0.00016 0.00016
79. Isophorone.................... 78591 ............ - ............ ................ ................ .......... ..............
80. Methyl Bromide................ 74839 ............ 0.50 0.02 1.4 ................ 300 ..............
81. Methylene Chloride............ 75092 0.002 - ............ 1.6 ................ 10 100
82. Methylmercury................. 22967926 ............ 2.7E-05 0.0001 ................ ................ .......... \b\ 0.03 (mg/
kg)
83. Nickel........................ 7440020 ............ 0.50 0.02 ................ 47 80 100
84. Nitrobenzene.................. 98953 ............ 0.50 0.002 3.1 ................ 30 100
85. N-Nitrosodimethylamine........ 62759 ............ - ............ ................ ................ .......... ..............
86. N-Nitrosodi-n-Propylamine..... 621647 ............ - ............ ................ ................ .......... ..............
87. N-Nitrosodiphenylamine........ 86306 ............ - ............ ................ ................ .......... ..............
88. Pentachlorophenol (PCP)....... 87865 0.4 - ............ 520 ................ 0.002 0.002
89. Phenol........................ 108952 ............ 0.50 0.6 1.9 ................ 9,000 70,000
90. Polychlorinated Biphenyls ......... 2 - ............ ................ 31,200 \c\ 7E-06 \c\ 7E-06
(PCBs)...........................
91. Pyrene........................ 129000 ............ 0.50 0.03 860 ................ 8 8
92. Selenium...................... 7782492 ............ 0.50 0.005 ................ 4.8 60 200
93. Tetrachloroethylene........... 127184 0.0021 - ............ 76 ................ 2.4 2.9
94. Thallium **................... 7440280 ............ - 0.000068 ................ 116 1.7 6.3
95. Toluene....................... 108883 ............ 0.50 0.0097 17 ................ 72 130
96. Toxaphene..................... 8001352 ............ - ............ ................ ................ .......... ..............
97. Trichloroethylene............. 79016 0.05 - ............ 13 ................ 0.3 0.7
98. Vinyl Chloride................ 75014 1.5 - ............ 1.7 ................ .......... 0.18
99. Zinc.......................... 7440666 ............ 0.50 0.3 ................ 47 1,000 1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ This criterion refers to the inorganic form of arsenic only.
\b\ This criterion is expressed as the fish tissue concentration of methylmercury (mg methylmercury/kg fish). See Water Quality Criterion for the
Protection of Human Health: Methylmercury (EPA-823-R-01-001, January 3, 2001) for how this value is calculated using the criterion equation in EPA's
2000 Human Health Methodology rearranged to solve for a protective concentration in fish tissue rather than in water.
\c\ This criterion applies to total PCBs (e.g., the sum of all congener or isomer or homolog or Aroclor analyses).
* Bis(2-Chloro-1-Methylethyl) Ether was previously listed as Bis(2-Chloroisopropyl) Ether.
** These criteria were promulgated for Washington in the National Toxics Rule at 40 CFR 131.36, and are moved into 40 CFR 131.45 to have one
comprehensive human health criteria rule for Washington.
(c) Applicability. (1) The criteria in paragraph (b) of this
section apply to waters with Washington's designated uses cited in
paragraph (d) of this section and apply concurrently with other
applicable water quality criteria.
(2) The criteria established in this section are subject to
Washington's general rules of applicability in the same way and to the
same extent as are other federally promulgated and state-adopted
numeric criteria when applied to the same use classifications in
paragraph (d) of this section.
(i) For all waters with mixing zone regulations or implementation
procedures, the criteria apply at the appropriate locations within or
at the boundary of the mixing zones; otherwise the criteria apply
throughout the waterbody including at the end of any discharge pipe,
conveyance or other discharge point within the waterbody.
(ii) The state must not use a low flow value below which numeric
non-carcinogen and carcinogen human health criteria can be exceeded
that is less stringent than the harmonic mean flow for waters suitable
for the establishment of low flow return frequencies (i.e., streams and
rivers). Harmonic mean flow is a long-term mean flow value calculated
by dividing the number of daily flows analyzed by the sum of the
reciprocals of those daily flows.
(iii) If the state does not have such a low flow value for numeric
criteria, then none will apply and the criteria in paragraph (b) of
this section herein apply at all flows.
(d) Applicable use designations. (1) All waters in Washington
assigned to the following use classifications are subject to the
criteria identified in paragraph (d)(2) of this section:
(i) Fresh waters--
(A) Miscellaneous uses: Harvesting (Fish harvesting);
(B) Recreational uses;
(C) Water supply uses: Domestic water (Domestic water supply);
(ii) Marine waters--
(A) Miscellaneous uses: Harvesting (Salmonid and other fish
harvesting, and crustacean and other shellfish (crabs, shrimp,
scallops, etc.) harvesting);
(B) Recreational uses;
(C) Shellfish harvesting: Shellfish harvest (Shellfish (clam,
oyster, and mussel) harvesting)
Note to paragraph (d)(1): The source of these uses is
Washington Administrative Code 173-201A-600 for Fresh waters and
173-201A-610 for Marine waters.
(2) For Washington waters that include the use classification of
Domestic Water, the criteria in column C1 and the methylmercury
criterion in column C2 of Table 1 in paragraph (b) of this section
apply. For Washington waters that include any of the following use
classifications but do not include the use classification of Domestic
Water, the criteria in column C2 of Table 1 in paragraph (b) of this
section apply: Harvesting (fresh and marine waters), Recreational Uses
(fresh and marine waters), and Shellfish Harvesting.
[FR Doc. 2016-28424 Filed 11-25-16; 8:45 am]
BILLING CODE 6560-50-P