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Rule2022-25150

Restoring Protective Human Health Criteria in Washington

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Published

November 18, 2022

Effective

December 19, 2022

Issuing agencies

Environmental Protection Agency

Abstract

On April 1, 2022, the Environmental Protection Agency (EPA) determined that Washington's human health criteria (HHC) for certain pollutants were not protective of Washington's designated uses and were not based on sound scientific rationale and, accordingly, proposed to restore protective HHC for those pollutants in Washington's waters. EPA is finalizing protective and science-based Federal HHC in this final rule to protect Washington's waters, including waters where tribes hold treaty-reserved rights to fish.

Full Text

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<title>Federal Register, Volume 87 Issue 222 (Friday, November 18, 2022)</title>
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[Federal Register Volume 87, Number 222 (Friday, November 18, 2022)]
[Rules and Regulations]
[Pages 69183-69201]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-25150]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[EPA-HQ-OW-2015-0174; FRL-7253.1-02-OW]
RIN 2040-AG21

Restoring Protective Human Health Criteria in Washington

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: On April 1, 2022, the Environmental Protection Agency (EPA)
determined that Washington's human health criteria (HHC) for certain
pollutants were not protective of Washington's designated uses and were
not based on sound scientific rationale and, accordingly, proposed to
restore protective HHC for those pollutants in Washington's waters. EPA
is finalizing protective and science-based Federal HHC in this final
rule to protect Washington's waters, including waters where tribes hold
treaty-reserved rights to fish.

DATES: This final rule is effective on December 19, 2022.

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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> website. Although listed in the index, some
information is not publicly available, e.g., Confidential Business
Information 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

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: <a href="/cdn-cgi/l/email-protection#66000a030f150f014803140f05072603160748010910">[email&#160;protected]</a>.

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?

[[Page 69184]]

II. Background
A. Statutory and Regulatory Background
B. EPA's General Approach for Deriving Human Health Criteria
C. Prior EPA Actions Related to Washington's Human Health
Criteria
III. Derivation of Human Health Criteria for Washington
A. Scope of EPA's Final Rule
B. Washington-Specific Human Health Criteria Inputs
C. Final Human Health Criteria for Washington
D. Applicability
E. 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 (PRA)
C. Regulatory Flexibility Act (RFA)
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
H. Executive Order 13211: 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 that are subject to Clean Water Act (CWA) regulatory
programs such as industrial facilities, stormwater management
districts, or publicly owned treatment works (POTWs) that discharge
pollutants to surface waters of the United States under the State of
Washington's jurisdiction could be affected by this rulemaking because
the Federal water quality standards (WQS) promulgated by EPA are
applicable WQS for surface waters in Washington for CWA purposes.
Categories and entities that could potentially be affected by this
rulemaking include the following:

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Category Examples of potentially affected entities
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Industry..................... Industrial point sources discharging
pollutants to waters of the United
States in Washington.
Municipalities............... Publicly owned treatment works or similar
facilities discharging pollutants to
waters of the United States in
Washington.
Stormwater Management Entities responsible for managing
Districts. stormwater in the State of Washington.
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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. 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 provided a
60-day public comment period after publishing the proposed rulemaking
in the Federal Register on April 1, 2022.\1\ In addition, EPA held two
online public hearings on May 24 and 25, 2022, to discuss the contents
of the proposed rulemaking and accept verbal public comments.
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\1\ See Restoring Protective Human Health Criteria in
Washington: Proposed Rule, 87 FR 19046, April 1, 2022.
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Over 20 organizations and individuals submitted comments on a range
of issues. EPA also received over 300 letters from individuals
associated with a mass letter writing campaign. Some comments addressed
issues beyond the scope of the rulemaking, and thus EPA did not
consider them in finalizing this rule. In this preamble, EPA provides
summaries of certain comments received on aspects of the proposal that
generated the most commenter interest. For a complete summary of all
comments received and EPA's responses, 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.'' EPA interprets these CWA section 101(a)(2) goals to
include, at a minimum, designated uses providing for the protection of
aquatic communities and human health related to consumption of fish and
shellfish.\2\
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\2\ USEPA. 2000. Memorandum 1BWQSP-00-03. U.S. Environmental
Protection Agency, Office of Water, Washington, DC, <a href="https://www.epa.gov/sites/production/files/2015-01/documents/standards-shellfish.pdf">https://www.epa.gov/sites/production/files/2015-01/documents/standards-shellfish.pdf</a>.
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Consistent with the CWA, EPA's WQS program assigns to states and
authorized tribes the primary authority for adopting WQS.\3\ 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 designated use.''
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\3\ 33 U.S.C. 1313(a), (c).
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Under CWA section 304(a), EPA periodically publishes criteria
(including HHC) recommendations for states to consider when adopting
water quality criteria for particular pollutants to protect CWA section
101(a) goal uses. Where EPA has published recommended criteria, states
should establish numeric water quality criteria based on EPA's CWA
section 304(a) criteria recommendations, CWA section 304(a) criteria
recommendations modified to reflect site-specific conditions, or other
scientifically defensible methods (40 CFR 131.11(b)(1)).
After a state adopts a new or revised WQS, the state must submit it
to EPA for review and action in accordance with CWA section 303(c).\4\
If EPA determines that a state's new or revised WQS is not consistent
with the requirements of the Act, the state has 90 days to submit a
modified standard. If the state fails to adopt a revised WQS that EPA
approves, CWA section 303(c)(4)(A) requires EPA to propose and
promulgate a revised or new standard for the waters involved. In
addition, CWA section 303(c)(4)(B) grants the EPA Administrator
discretion

[[Page 69185]]

to determine ``that a revised or new standard is necessary to meet the
requirements of [the Act].'' \5\ After making such a determination,
known as an Administrator's Determination,\6\ the agency must
``promptly'' propose an appropriate WQS and finalize it within ninety
days unless the state adopts an acceptable standard in the interim.\7\
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\4\ 33 U.S.C. 1313(c)(2)(A), (c)(3).
\5\ Id. at (c)(4)(B).
\6\ 40 CFR 131.22(b)
\7\ 33 U.S.C. 1313(c)(4)(B).
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B. EPA's General Approach for Deriving Human Health Criteria

EPA's 2000 Methodology for Deriving Ambient Water Quality Criteria
for the Protection of Human Health \8\ (2000 Methodology) describes the
methods EPA uses when developing national CWA section 304(a)
recommended HHC and when promulgating Federal HHC. The 2000 Methodology
also serves as guidance to states and authorized tribes for developing
their own HHC. EPA's guidance informs, but does not dictate, EPA's
implementation of the applicable statutory and regulatory requirements
noted above. EPA's 2000 Methodology recommends that HHC be designed to
reduce 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/shellfish obtained from inland and nearshore
waters. Consistent with the 2000 Methodology, EPA's practice is to
establish a criterion for both drinking water ingestion and consumption
of fish/shellfish from inland and nearshore waters combined and a
separate criterion based on ingestion of fish/shellfish from inland and
nearshore waters alone. This latter criterion applies in cases where
the designated uses of a waterbody include supporting fish/shellfish
for human consumption but not drinking water supply sources (e.g., non-
potable estuarine waters).
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\8\ USEPA. 2000. Methodology for Deriving Ambient Water Quality
Criteria for the Protection of Human Health. U.S. Environmental
Protection Agency, Office of Water, Washington, DC EPA-822-B-00-004.
<a href="https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf">https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf</a>.
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Consistent with EPA's 2000 Methodology, EPA establishes HHC based
on two types of toxicological endpoints: (1) carcinogenicity; and (2)
noncancer toxicity (i.e., all adverse effects other than cancer). Where
sufficient data are available, EPA derives criteria using both
carcinogenic and non-carcinogenic toxicity endpoints and uses the lower
(i.e., more health-protective) value. EPA calculates HHC for
carcinogenic effects using the following input parameters: cancer slope
factor (CSF), cancer risk level (CRL), body weight, drinking water
intake rate, fish consumption rate (FCR), and a bioaccumulation
factor(s). EPA calculates HHC for both non-cancer and nonlinear
carcinogenic effects using a reference dose (RfD) and relative source
contribution (RSC) in place of a CSF and CRL (the remaining inputs are
the same for both toxicology endpoints). The RSC is applied to
apportion the RfD among the media and exposure routes of concern for a
particular chemical to ensure that an individual's total exposure from
all exposure sources does not exceed the RfD. Each of these inputs is
discussed in more detail in sections II.B.a through II.B.d of this
preamble and in EPA's 2000 Methodology.\9\
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\9\ Id.
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a. Cancer Risk Level
Consistent with the 2000 Methodology, EPA generally assumes, in the
absence of data to indicate otherwise, that carcinogens exhibit linear
``non-threshold'' dose-responses which means that there are no ``safe''
or ``no-effect'' levels. Therefore, EPA calculates HHC for carcinogenic
effects as pollutant concentrations corresponding to lifetime increases
in the risk of developing cancer. EPA calculates HHC values at a
10-6 (one in one million) CRL and recommends that states and
authorized tribes use CRLs of 10-6 or 10-5 (one
in one hundred thousand) when deriving HHC for the general
population.\10\ EPA notes that states and authorized tribes can also
choose a more health protective risk level, such as 10-7
(one in ten million), when deriving HHC.
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\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.''
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b. Cancer Slope Factor and Reference Dose
A dose-response assessment is required to understand the
quantitative relationships between exposure to a pollutant and adverse
health effects. EPA evaluates dose-response relationships based on the
available data from animal toxicity and human epidemiological studies
to derive dose-response metrics. For carcinogenic effects, EPA uses an
oral CSF to derive the HHC. 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 pollutant. For non-carcinogenic
effects, EPA uses the reference dose (RfD) to calculate the HHC. 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 often derived from a laboratory animal
toxicity multi-dose study from which a no-observed-adverse-effect level
(NOAEL), lowest-observed-adverse-effect level (LOAEL), or benchmark
dose level can be identified. However, human epidemiology studies can
also be used to derive a RfD. Uncertainty factors are applied to
account for gaps or deficiencies in the available data (e.g.,
differences in response among humans) for a chemical. For the majority
of EPA's latest (2015) updated national CWA section 304(a) recommended
HHC, EPA's Integrated Risk Information System (IRIS) \11\ was the
source of both cancer and noncancer toxicity values (i.e., RfD and
CSF).\12\ For some pollutants, EPA selected risk assessments produced
by other EPA program offices (e.g., Office of Pesticide Programs,
Office of Water, Office of Land and Emergency Management), other
national and international programs, and state programs.
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\11\ USEPA. Integrated Risk Information System (IRIS). U.S.
Environmental Protection Agency, Office of Research and Development,
Washington, DC <a href="http://www.epa.gov/iris">www.epa.gov/iris</a>.
\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, <a href="https://www.epa.gov/wqc/human-health-water-quality-criteria">https://www.epa.gov/wqc/human-health-water-quality-criteria</a>.
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c. Exposure Assumptions
EPA's exposure assumptions provide an overall level of protection
targeted at the high end of the general population, as stated in the
2000 Methodology. EPA selects a combination of high-end and central
tendency inputs to the criteria derivation equation and avoids ``double
counting'' of exposures and combining unlikely co-occurrences.
Consistent with the 2015 national CWA section 304(a) recommended HHC,
EPA uses a default drinking water intake rate of 2.4 liters per day (L/
day) and default rate of 22 grams per day (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 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

[[Page 69186]]

and older.\13\ EPA's national 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 Nutrient Examination Survey
(NHANES) data from 2003 to 2010.14 15 EPA calculates HHC
using a default body weight of 80 kilograms (kg), the average weight of
a U.S. adult age 21 and older, based on NHANES data from 1999 to 2006.
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\13\ USEPA. 2011. EPA Exposure Factors Handbook. 2011 edition
(EPA 600/R-090/052F). <a href="https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=236252">https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=236252</a>.
\14\ 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.
\15\ 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.
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Prior to publication of the 2000 Methodology, in which EPA began
recommending the use of BAFs to reflect the uptake of a contaminant
from all sources by fish and shellfish,\16\ EPA relied on
bioconcentration factors (BCFs) to estimate chemical accumulation of
waterborne chemicals by aquatic organisms. However, BCFs only account
for chemical accumulation in aquatic organisms through exposure to
chemicals in the water column. In 2000, EPA noted that ``there has been
a growing body of scientific knowledge that clearly supports the
observation that bioaccumulation and biomagnification occur and are
important exposure issues to consider for many highly hydrophobic
organic compounds and certain organometallics.'' For that reason, the
2000 Methodology observed that ``[f]or highly persistent and
bioaccumulative chemicals that are not easily metabolized, BCFs do not
reflect what the science indicates.'' \17\ Therefore, consistent with
the 2000 Methodology EPA uses, when data are available, measured or
estimated BAFs, which account for chemical accumulation in aquatic
organisms from all potential exposure routes, including, but not
limited to, food, sediment, and water.\18\ EPA uses separate BAFs for
each trophic level to account for potential biomagnification of
chemicals in aquatic food webs, as well as physiological differences
among organisms that may affect bioaccumulation.\19\
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\16\ 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.
<a href="https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf">https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf</a> at 5-4. (Explaining that
``[t]he 1980 Methodology for deriving 304(a) criteria for the
protection of human health emphasized the assessment of
bioconcentration (uptake from water only) through the use of the
BCF. . .The 2000 Human Health Methodology revisions contained in
this chapter emphasize the measurement of bioaccumulation (uptake
from water, sediment, and diet) through the use of the BAF.'').
\17\ 65 FR 66444 (November 3, 2000).
\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.
<a href="https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf">https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf</a>.
\19\ USEPA. 2003. Methodology for Deriving Ambient Water Quality
Criteria for the Protection of Human Health (2000). Technical
Support Document Volume 2: Development of National Bioaccumulation
Factors. U.S. Environmental Protection Agency, Office of Water,
Washington, DC EPA-822-B-03-030. <a href="https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf">https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf</a>.
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EPA derives national default BAFs, in part, as a resource for
states and authorized tribes with limited resources for deriving site-
specific BAFs.\20\ EPA's approach for developing national BAFs
represents the long-term average bioaccumulation potential of a
pollutant in aquatic organisms that are commonly consumed by humans
across the United States. In the 2015 national CWA section 304(a)
recommended HHC update, EPA relied on field-measured BAFs and
laboratory-measured BCFs available from peer-reviewed, publicly
available databases to develop national BAFs for three trophic levels
of fish.\21\ If this information was not available, EPA selected
octanol-water partition coefficients (K<INF>ow</INF> values) from
publicly available, published peer-reviewed sources for use in
calculating national BAFs. As an additional line of evidence, EPA
reported model-estimated BAFs for every chemical based on the
Estimation Program Interface (EPI) Suite to support the field-measured
or predicted BAFs.\22\
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\20\ 65 FR 66444 (November 3, 2000).
\21\ 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, <a href="https://www.epa.gov/wqc/human-health-water-quality-criteria">https://www.epa.gov/wqc/human-health-water-quality-criteria</a>.
\22\ Id.
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Although EPA uses national default exposure-related input values to
calculate national CWA section 304(a) recommended criteria, EPA's
methodology notes a preference for the use of local data, when
available, to calculate HHC (e.g., locally derived FCRs, drinking water
intake rates and body weights, and waterbody-specific bioaccumulation
rates) over national default values. Using local data helps ensure that
HHC represent local conditions.\23\ EPA also recommends, where
sufficient data are available, selecting an FCR that reflects
consumption that is not suppressed by fish availability or concerns
about the safety of available fish.\24\ Deriving criteria using an
unsuppressed FCR furthers the restoration goals of the CWA and ensures
protection of human health as pollutant levels decrease, fish habitats
are restored, and fish availability increases. Moreover, as explained
further below, selecting an FCR that reflects unsuppressed fish
consumption could be necessary where tribal treaty or other reserved
fishing rights apply. In such circumstances, if sufficient data
regarding unsuppressed fish consumption levels are unavailable or
inconclusive, states should consult with tribes when deciding which
fish consumption data should be used in selecting an FCR.
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\23\ 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.
<a href="https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf">https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf</a>.
\24\ 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) (NEJAC Fish
Consumption Report), available at <a href="https://www.epa.gov/sites/default/files/2015-02/documents/fish-consump-report_1102.pdf">https://www.epa.gov/sites/default/files/2015-02/documents/fish-consump-report_1102.pdf</a>.
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d. Relative Source Contribution
The inclusion of an RSC factor \25\ is important for protecting
public health. When deriving HHC for non-carcinogens and nonlinear
carcinogens, EPA includes an RSC factor to account for sources of
exposure other than drinking water and consumption of fish and
shellfish from inland and nearshore

[[Page 69187]]

waters. These other sources of exposure include but are not limited to
ocean fish 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. Using an RSC
ensures that the level of a chemical allowed by a water quality
criterion, when combined with other exposure sources, will not result
in exposures that exceed the RfD, thus helping to prevent adverse
health effects from aggregate exposure to a given chemical over a
person's lifetime. EPA's guidance \26\ includes an approach for
determining an appropriate RSC for a given pollutant ranging in value
from 0.2 to 0.8 to ensure that drinking water and fish consumption
alone are not apportioned the entirety of the RfD. This approach, known
as the Exposure Decision Tree, considers the adequacy of available
exposure data, levels of exposure, relevant sources/media of exposure,
and regulatory agendas. As explained below in section III.B.d of this
preamble, EPA made science-based adjustments to the application of the
RSC in this rulemaking to avoid ``double counting'' exposures.
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\25\ ``[RSC] defines the portion of the total exposure that
comes from ingestion of water and fish from the ambient water body
of interest. Other exposure information such as that from dietary,
inhalation, and dermal routes should be considered and accounted for
as part of the RSC human exposure analysis.'' <a href="https://www.epa.gov/wqs-tech/supplemental-module-human-health-ambient-water-quality-criteria">https://www.epa.gov/wqs-tech/supplemental-module-human-health-ambient-water-quality-criteria</a>.
\26\ Id.
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C. Prior EPA Actions Related to Washington's Human Health Criteria

In 1992, EPA promulgated the National Toxics Rule (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). Subsequently, when states covered by the NTR
adopted their own criteria for toxic pollutants that were consistent
with the CWA and EPA's implementing regulations, EPA amended the NTR to
remove those chemical-specific criteria for those states. In 2015,
Washington was one of the states that remained covered by the NTR.
On September 14, 2015, the EPA Administrator determined that
updated HHC for Washington were ``necessary'' pursuant to CWA section
303(c)(4)(B). EPA proposed HHC to protect the health of Washington
residents, including tribes with treaty-reserved rights to fish.\27\ In
that proposal, EPA explained that the majority of waters under
Washington's jurisdiction are subject to tribal treaty-reserved fishing
rights.\28\ To give effect to such rights in establishing revised WQS
for Washington waters, EPA determined that tribal treaty fishing rights
``appropriately must be considered when determining which criteria are
necessary to adequately protect Washington's fish and shellfish
harvesting designated uses.'' \29\ Specifically, EPA proposed to
consider the tribal populations exercising their legal right to harvest
and consume fish and shellfish as the general population for purposes
of deriving protective HHC. To this end, EPA proposed HHC based on an
FCR of 175 g/day and CRL of 10-6 to reflect consideration of
tribal treaty-reserved rights, as informed by consultation with the
tribes and fish consumption surveys of tribal members.\30\ In addition
to an FCR and CRL calculated to ensure protection of applicable tribal
treaty-reserved rights, EPA also utilized other inputs to derive the
proposed HHC based on the agency's latest scientific knowledge.
Specifically, EPA calculated the proposed HHC using the national
trophic level four BAFs and updated chemical-specific RSC values from
its June 2015 CWA section 304(a) recommended criteria updates.\31\
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\27\ 80 FR 55063 (September 14, 2015).
\28\ Id. at 55067.
\29\ Id.
\30\ Id. at 55067-68.
\31\ Id. at 55068-69.
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Before EPA finalized the proposed Federal criteria, the State of
Washington adopted HHC following an extensive public process and
submitted the updated HHC to EPA for review on August 1, 2016. The
updated HHC incorporated some of the new data and information from
EPA's June 2015 CWA section 304(a) criteria updates. Washington's HHC
were based on the same 175 g/day FCR and 10-6 CRL that EPA
used to derive the proposed Federal HHC, with the exception of the CRL
for polychlorinated biphenyls (PCBs).\32\ Although Washington used the
same FCR and CRL as EPA, Washington used BCFs instead of BAFs and used
an RSC of 1. The scientific inputs of BCFs and an RSC of 1 do not
reflect the latest scientific knowledge.
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\32\ For PCBs, Washington's criteria were based on a chemical-
specific CRL of 2.3 x 10-5.
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On November 15, 2016, EPA partially approved and partially
disapproved Washington's HHC.\33\ For the criteria that were
disapproved, EPA concurrently signed a final rule promulgating the
Federal criteria it had proposed in 2015.\34\ Like EPA's 2015 proposal,
the 2016 final rule articulated EPA's conclusion that it is necessary
and appropriate to consider tribal treaty-reserved rights within the
framework of the CWA and provided a discussion of the tribal treaties
relevant to the State of Washington and applicable case law.\35\ The
2016 final rule was informed by public comment that addressed both the
proposed criteria and EPA's consideration of tribal treaties, as well
as consultation with a number of federally recognized tribes.
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\33\ Letter from Dan D. Opalski, Director, EPA Region 10 Office
of Water and Watersheds to Maia Bellon, Director, Department of
Ecology, Re: EPA's Partial Approval/Partial Disapproval of
Washington's Human Health Water Quality Criteria and Implementation
Tools; Enclosure, Technical Support Document (November 15, 2016)
(2016 Partial Approval/Partial Disapproval).
\34\ 81 FR 85417 (November 28, 2016).
\35\ 81 FR 85422-27 (November 28, 2016).
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EPA's disapproval of Washington's HHC in 2016 was largely
predicated on Washington's use of input values that were not reflective
of sound scientific rationale. In its letter to the State, EPA
explained that the agency ``evaluated Washington's criteria values
against criteria that EPA determined would be protective of the State's
designated uses and scientifically defensible (e.g., based on
appropriate bioaccumulation factors (BAFs) and protective relative
source contribution (RSC) values of less than 1).'' \36\ EPA found that
Washington had not demonstrated that the majority of its criteria were
based on sound scientific rationale as required by the CWA and EPA's
implementing regulations.\37\ Specifically for PCBs, EPA found that
Washington had not provided adequate support or analysis to justify its
use of a chemical-specific CRL (2.3 x 10-5) that was less
stringent than the CRL used for all other pollutants, and did not
explain how the use of this CRL was protective of the State's
designated uses.\38\
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\36\ 2016 Partial Approval/Disapproval at 3.
\37\ Id. at 16-17.
\38\ Id. at 26 (Determining that Washington ``did not provide
adequate justification for using the Washington Department of Health
cancer risk level for this specific chemical and then adjusting that
cancer risk level so that the criteria would be equivalent to the
NTR criteria'' and ``did not demonstrate how the criteria were
derived using a cancer risk level that is based on scientifically
sound rationale and protective of applicable designated uses,
including the tribal subsistence fishing portion of the fish and
shellfish harvesting use as informed by treaty-reserved fishing
rights.'').
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With respect to the criteria that EPA approved, the agency also
explained that ``while the EPA carefully considers the scientific
defensibility and protectiveness of both the inputs used to derive
criteria and the resulting criteria values, it is ultimately on the
criteria values that the EPA takes approval or disapproval action under
CWA section 303(c).'' \39\ After evaluating Washington's criteria
against criteria using appropriate scientific inputs, EPA determined
that certain of Washington's criteria were as or more stringent than

[[Page 69188]]

scientifically defensible criteria that the EPA determined would be
protective of Washington's designated uses.\40\ Accordingly, EPA
approved those criteria.\41\
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\39\ Id. at 8.
\40\ Id.
\41\ Id.
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In a petition dated February 21, 2017, several regulated entities
requested that EPA reconsider its November 15, 2016, partial
disapproval and repeal its concurrent promulgated Federal criteria.\42\
Following the 2017 petition, Washington and several federally
recognized tribes with treaty-reserved fishing rights sent letters
urging EPA to deny the petition and to leave the federally promulgated
HHC in place.\43\
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\42\ Petition submitted by Northwest Pulp and Paper Association,
America Forest and Paper Association, Association of Washington
Business, Greater Spokane Incorporated, Treated Wood Council,
Western Wood Preservers Institute, Utility Water Act Group and the
Washington Farm Bureau.
\43\ EPA received letters from the Washington State Department
of Ecology, Washington State Attorney General, the Northwest Indian
Fisheries Commission, the Lower Elwha Klallam Tribe, the Nooksack
Indian Tribe, the Jamestown S'Klallam Tribe, and Earthjustice (on
behalf of the Pacific Coast Federation of Fishermen's Associations,
Institute for Fisheries Resources, and several Washington
Waterkeepers).
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Despite objections from the State and several tribes, on May 10,
2019, EPA granted the 2017 industry petition by reversing the agency's
prior partial disapproval to an approval of certain HHC (`2019
Reconsidered HHC') and subsequently issuing a final rule withdrawing
the federally promulgated criteria.\44\ EPA's May 10, 2019 approval
concluded that the State's reliance on scientific inputs that were not
reflective of the latest science was an appropriate risk-management
decision.\45\ The withdrawal of the Federal criteria went into effect
on June 12, 2020, and as of that date, the HHC submitted by Washington
on August 1, 2016 and approved by EPA on May 10, 2019 were in effect
for CWA purposes.
---------------------------------------------------------------------------

\44\ May 10, 2019 letter and enclosed Technical Support Document
from Chris Hladick, Regional Administrator, EPA Region 10, to Maia
Bellon, Director, Department of Ecology, Re: EPA's Reversal of the
November 15, 2016 Clean Water Act section 303(c) Partial Disapproval
of Washington's Human Health Water Quality Criteria and Decision to
Approve Washington's Criteria; Withdrawal of Certain Federal Water
Quality Criteria Applicable to Washington, 85 FR 28494 (May 13,
2020).
\45\ May 10, 2019 letter at pp. 8, 14-15.
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On June 6, 2019, the State of Washington filed a complaint
challenging the legality of EPA's May 2019 decision to reverse its
November 2016 partial disapproval.\46\ The Sauk-Suiattle Indian Tribe
and Quinault Indian Nation subsequently joined Washington's lawsuit as
plaintiff-intervenors. On June 6, 2020, following EPA's withdrawal of
the promulgated Federal HHC, another lawsuit was filed by the Makah
Indian Tribe, the Pacific Coast Federation of Fishermen's Associations,
and environmental groups challenging both EPA's withdrawal of the
federally promulgated HHC and its May 10, 2019 decision to reverse the
November 2016 partial disapproval.\47\ In September 2020, the
Plaintiffs in the case filed by the State of Washington amended their
complaints to also challenge EPA's rule withdrawing the Federal HHC.
---------------------------------------------------------------------------

\46\ State of Washington v. U.S. Envt'l Prot. Agency, No. 2:19-
cv-884-RAJ (W.D. Wash.).
\47\ Puget Soundkeeper Alliance et al. v. U.S. Envt'l Prot.
Agency, No. 2:20-cv-907-RAJ (W.D. Wash.).
---------------------------------------------------------------------------

Consistent with Executive Order 13990,\48\ in February 2021, EPA
sought and was granted an abeyance in both cases to conduct an initial
review to determine whether it intended to reconsider the challenged
actions. During this initial three-month abeyance, EPA decided to
reconsider the challenged actions. Based on its initial review of the
agency's prior actions, EPA sought a longer abeyance from the court,
expressing substantial concern that Washington's HHC may not be
adequately protective and may not be based on sound scientific
rationale. On July 6, 2021, the Court granted EPA an abeyance to
reconsider its prior actions and to propose protective HHC for
Washington and take final action on the proposal within 18 months. EPA
proposed protective HHC for Washington on April 1, 2022,\49\ and is now
finalizing protective HHC for Washington in this final rule.
---------------------------------------------------------------------------

\48\ 86 FR 7037 (January 25, 2021).
\49\ See Restoring Protective Human Health Criteria in
Washington: Proposed Rule, 87 FR 19046, April 1, 2022.
---------------------------------------------------------------------------

III. Derivation of Human Health Criteria for Washington

A. Scope of EPA's Final Rule

After consideration of all comments received on EPA's proposed
rulemaking, EPA is finalizing Federal criteria that supersede the 2019
Reconsidered HHC for CWA purposes.\50\ EPA's final rule does not change
or supersede the Federal HHC that EPA promulgated for arsenic,\51\
methylmercury, or bis (2-chloro-1-methylethyl) ether in 2016 and that
remain in place for CWA purposes, nor Washington's HHC that EPA
approved in 2016 and have remained in effect since that time. EPA's
final rule also does not change or supersede Washington's HHC for
dioxin and thallium that EPA approved in 2019. EPA had previously taken
no action on these two pollutants in 2016.
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\50\ See 40 CFR 131.21(c).
\51\ EPA promulgated arsenic HHC for Washington in the National
Toxics Rule of 1992. EPA's Federal rule in 2016 moved the arsenic
criteria from 40 CFR 131.36 to 40 CFR 131.45.
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Some commenters asked EPA to quickly take separate prompt action to
strengthen dioxin criteria and establish criteria for per- and
polyfluoroalkyl substances (PFAS) unless Washington addresses those
pollutants itself in a future State rulemaking. As noted in EPA's
Response to Comment document in the docket for this rule, such comments
are beyond the scope of this rulemaking.
Finally, certain commenters referred to EPA's prior actions related
to HHC for arsenic and mercury in Washington. EPA's proposed rulemaking
did not address those prior actions, which were based on the
administrative record before the agency at that time, nor did EPA
solicit comment on those actions. Therefore, such comments are also
beyond the scope of this rule.
The HHC in this final rule apply to surface waters under the State
of Washington's jurisdiction, and not to waters within Indian
country,\52\ unless otherwise specified in Federal law.
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\52\ See 18 U.S.C. 1151 for definition of Indian Country.
---------------------------------------------------------------------------

B. Washington-Specific Human Health Criteria Inputs

a. Fish Consumption Rate, Body Weight, Drinking Water Intake
EPA is finalizing HHC for Washington using the same FCR of 175 g/
day, body weight of 80 kg and drinking water intake rate of 2.4 L/day
that the agency proposed in its April 1, 2022, proposed rulemaking,\53\
which are the same values Washington used in 2016 \54\ and that EPA
used in its 2016 Federal rule.\55\ The comments addressing these input
values are briefly summarized below.
---------------------------------------------------------------------------

\53\ See Restoring Protective Human Health Criteria in
Washington: Proposed Rule, 87 FR 19046, April 1, 2022.
\54\ Department of Ecology. Washington State Water Quality
Standards: Human health criteria and implementation tools, Overview
of key decisions in rule amendment. August 2016. Ecology Publication
no. 16-10-025.
\55\ Revision of Certain Water Quality Standards Applicable to
Washington, 81 FR 85417 (November 28, 2016).
---------------------------------------------------------------------------

With respect to the FCR, some commenters asserted that protective
HHC should accurately account for the amount of fish people are eating,
and that EPA was right to propose HHC using an FCR of 175 g/day.
However, the same commenters state that 175 g/day is a compromise rate
and is therefore, not conservative because many communities in
Washington eat more than 175 g/day, even with suppressed fish stocks.
Those

[[Page 69189]]

commenters assert that 175 g/day is only acceptable if that rate is
paired with a CRL of one in one million (10-6) and the most
recent science for the other inputs.
Other commenters asserted that 175 g/day is an inappropriate FCR to
use to derive HHC in Washington, and/or that it should not be paired
with a 10-6 CRL. These commenters state that lower FCRs, or
greater CRLs of one in one hundred thousand (10-5) or one in
ten thousand (10-4), would be protective of all consumers in
Washington, including tribes. Some commenters characterized 175 g/day
as a high-biased estimate of fish consumption that is based on an
outdated survey method. Additionally, commenters assert that 175 g/day
is too high to use to derive HHC for Washington because it includes
consumption of fish that predominantly accumulate pollutants in waters
outside of Washington's jurisdiction (i.e., the open ocean). Commenters
state that EPA relies in part on an argument that fish consumption in
Washington is suppressed but assert that EPA has not provided
scientific evidence of such suppression or guidance on how to account
for suppression. These commenters state that there is no evidence of
lower fish stocks limiting consumption, and that fish availability
should not be a factor in setting HHC since those criteria do not
impact fish availability.
EPA reiterates its explanation in the proposed rulemaking that it
does not have new data or information suggesting a need to revisit the
inputs utilized in the 2016 rule.\56\ Thus, EPA is applying the same
rationale here as the agency articulated to support its use of those
inputs in the 2016 Federal rule. The agency has concluded that it is
important to keep these values consistent between the HHC in this rule
and the other HHC that this rule will not impact (i.e., the HHC that
Washington adopted and EPA approved in 2016, and the Federal HHC that
remain in place for arsenic, methylmercury, or bis (2-chloro-1-
methylethyl) ether), because these values are associated with the
population that the criteria are intended to protect and are not
pollutant-specific. For detailed responses to all comments received,
see EPA's Response to Comment document in the docket for this rule.
---------------------------------------------------------------------------

\56\ Id. at 85420; 85426-428.
---------------------------------------------------------------------------

b. Pollutant-Specific Reference Doses and Cancer Slope Factors
EPA is finalizing HHC for Washington using the same reference doses
and cancer slope factors that the agency proposed in its April 1, 2022,
proposed rulemaking,\57\ which are the same values Washington used in
2016 \58\ and that EPA used in its 2016 Federal rule.\59\ These are the
same toxicity values that EPA uses in its national CWA section 304(a)
recommended HHC. While there may be new toxicity information available
for certain pollutants that is not yet reflected in EPA's CWA section
304(a) national recommended HHC, such information has not yet been
reviewed through EPA's comprehensive CWA section 304(a) criteria
development process and therefore is not incorporated into this final
rule.\60\ See Table 1, columns B1 and B3 of this preamble for a list of
EPA's toxicity factors by pollutant.
---------------------------------------------------------------------------

\57\ See Restoring Protective Human Health Criteria in
Washington: Proposed Rule, 87 FR 19046, April 1, 2022.
\58\ Department of Ecology. Washington State Water Quality
Standards: Human health criteria and implementation tools, Overview
of key decisions in rule amendment. August 2016. Ecology Publication
no. 16-10-025.
\59\ Revision of Certain Water Quality Standards Applicable to
Washington, 81 FR 85417 (November 28, 2016).
\60\ For example, there are 7 polycyclic aromatic hydrocarbons
for which there is new toxicity information available since the
promulgation of the 2016 Federal rule. Because the CWA section
304(a) criteria development process can take several years, EPA is
not able to review this information and complete this rulemaking by
the end of the 18-month abeyance. Once EPA has developed updated CWA
section 304(a) criteria for these pollutants, the State may evaluate
its HHC for these pollutants (e.g., during a triennial review),
adopt new HHC based on the CWA section 304(a) updates, and submit
these HHC to EPA for review.
---------------------------------------------------------------------------

EPA only received comments on reference doses and cancer slope
factors in the context of specific pollutants, namely PCBs and mercury.
As noted above, comments on mercury are beyond the scope of this
rulemaking. For comments on PCBs, see below and EPA's Response to
Comment document in the docket for this rule.
c. Cancer Risk Level
EPA is finalizing HHC for Washington using the same CRL of
10-6 that the agency proposed in its April 1, 2022, proposed
rulemaking for all pollutants, including PCBs.\61\ This is the same CRL
Washington used in 2016 for all pollutants except for PCBs \62\ and
that EPA used in its 2016 Federal rule for all pollutants.\63\
---------------------------------------------------------------------------

\61\ See Restoring Protective Human Health Criteria in
Washington: Proposed Rule, 87 FR 19046, April 1, 2022.
\62\ Department of Ecology. Washington State Water Quality
Standards: Human health criteria and implementation tools, Overview
of key decisions in rule amendment. August 2016. Ecology Publication
no. 16-10-025.
\63\ Revision of Certain Water Quality Standards Applicable to
Washington, 81 FR 85417 (November 28, 2016).
---------------------------------------------------------------------------

EPA's selection of a 10-6 CRL is consistent with EPA's
2000 Methodology, which states that EPA intends to use the
10-6 level, which reflects an appropriate risk for the
general population, when promulgating water quality criteria for states
and tribes.\64\ Additionally, many of Washington's rivers are in the
Columbia River basin, upstream of Oregon's portion of the Columbia
River. Oregon's criteria for PCBs and other pollutants are based on an
FCR of 175 g/day and a CRL of 10-6. EPA's final Federal HHC
for Washington using a CRL of 10-6 along with an FCR of 175
g/day helps ensure that Washington's criteria will provide for the
attainment and maintenance of Oregon's downstream WQS as required by 40
CFR 131.10(b).
---------------------------------------------------------------------------

\64\ EPA 2000 Methodology, p. 2-6. The Methodology recommends
that states set human health criteria CRLs for the target general
population at either 10-5 or 10-6 (p. 2-6) and
also notes that states and authorized tribes can always choose a
more stringent risk level, such as 10-7 (p. 1-12).
---------------------------------------------------------------------------

As noted in EPA's 2016 final rule for Washington,\65\ several
tribes in Washington have treaty-reserved rights to fish on waters
throughout the State. Consistent with those rights, tribal members
catch and consume fish for their subsistence. EPA determined that a
10-6 CRL was appropriate independent of treaty rights, for
the reasons explained in this section and EPA's Response to Comment
document in the docket for this rule. Nonetheless, EPA's selection of a
10-6 CRL is protective of tribal members exercising their
legal right to harvest and consume fish and shellfish at subsistence
levels.\66\
---------------------------------------------------------------------------

\65\ 81 FR 85422-26 (November 28, 2016).
\66\ In 2016, tribes in Washington State generally viewed 175 g/
day as a compromise minimum consumption rate so long as it is
coupled with a CRL of 10-6. 2016 Partial Approval/
Disapproval p. 15.
---------------------------------------------------------------------------

Some commenters asserted that EPA's use of a CRL of 10-6
is consistent with EPA's guidance and national precedent. These
commenters agreed with EPA's proposal of HHC for PCBs based on a CRL of
10-6 paired with an FCR of 175 g/day and asserted that it
violates the CWA and civil rights to expose high fish consumers to a
higher cancer risk due to PCBs. Commenters stated that EPA did not show
why Washington's criteria that it previously disapproved in 2016 were
protective in 2019. Finally, commenters asserted that upstream
pollution impacts the Spokane Tribe's ability to safely exercise their
treaty reserved fishing rights and EPA's proposed PCB criteria are
closer to the Tribe's criteria and therefore more likely to provide for
downstream protection. Commenters also state that use of a CRL

[[Page 69190]]

of 10-6 to derive HHC for Washington addresses the potential
for synergistic toxicity from exposure to multiple toxins.
Other commenters asserted that EPA's use of a 10-6 CRL
is inconsistent with EPA's guidance and longstanding policy on
acceptable risk levels. These commenters stated that EPA accepts CRLs
of 10-6 or 10-5, provided the median FCR for
highly exposed populations is protected to a 10-4 risk
level, and pointed to prior EPA actions, including EPA's 2019 approval
of HHC in Idaho, 2011 HHC approval in Oregon, and EPA's Clean Water Act
national recommended 304(a) criteria that pair a 10-6 cancer
risk level with a general population fish consumption rate rather than
an FCR associated with high fish consumers. Some commenters
characterized a CRL of 10-4 as effectively zero risk to a
small population such as the tribal population in Washington. Other
commenters argued that the CRL is a choice for states to make and that
EPA was right to accept Washington's choice of a PCB-specific CRL in
2019 because Washington's 2016 PCB criteria strike a more appropriate
balance between cost and human health protection, and EPA's proposed
PCB criteria are not scientifically defensible or attainable with
currently available technology. Some commenters raised concerns that
EPA's proposed criteria are below analytical method quantitation limits
and therefore it is not clear how dischargers can comply with the
criteria and this could be misleading to the public. Some commenters
criticized EPA's cost estimates for the proposed rule, stating that
testing methodology may improve, such that dischargers will then be out
of compliance with permit limits, and stating that Washington is
unlikely to adopt WQS variances to provide dischargers with relief.
These commenters asserted that certain dischargers are already being
pushed by EPA to use an unapproved PCB test method as the basis to
design and install new treatment systems, and that EPA was wrong to
assume that PCBs are not likely to be found in the effluent from minor
facilities. Some commenters raised concerns that EPA and Washington
State allow for the continued release of PCBs into the environment
under the Toxic Substances Control Act, tribal and Federal hatchery
operations in Washington, and Washington's Model Toxics Control ACT,
which in turn puts an unfair burden on dischargers in Washington to
meet the proposed HHC for PCBs. Commenters also raised concerns that
EPA has not shared the latest science evaluating the toxicity of
inadvertently generated PCBs and there is ongoing scientific
uncertainty with EPA's proposed PCB criteria that EPA has not
sufficiently explained.
As noted above, in this final rule EPA is maintaining its proposed
CRL of 10-6, which Washington used in 2016 and EPA used in
its 2016 Federal rule for all pollutants. With respect to the comments
regarding utilizing that same CRL for PCBs, for the reasons that EPA
further explained in the proposed rulemaking, the agency has concluded
that Washington's PCB HHC are not protective of Washington's designated
uses because of Washington's selected chemical-specific CRL, which is
not based on a sound scientific rationale. For detailed responses to
all comments received, including those which reiterate prior comments
that EPA received on its 2015 proposed rulemaking for Washington and
previously responded to, such as comments about the intersection of the
CWA and the Toxic Substances Control Act with respect to PCBs, see
EPA's Response to Comment document in the docket for this rule.
d. Relative Source Contribution
EPA recommends using an 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.B.d of this preamble). In its 2015 304(a) criteria
recommendations, 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 Human Health Methodology.67 68
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\67\ 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.
<a href="https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf">https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf</a>.
\68\ 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 <a href="https://www.epa.gov/wqc/human-health-water-quality-criteria">https://www.epa.gov/wqc/human-health-water-quality-criteria</a>.
---------------------------------------------------------------------------

When EPA promulgated HHC for Washington in 2016, EPA adjusted RSC
values using a ratio of the national dataset characterizing all FCRs
versus inland and nearshore-only FCRs derived from the NHANES dataset.
EPA then applied this ratio to the proportion of the RfD reserved for
inland and nearshore fish consumption in the RSC, and used this
adjustment to account for double-counted potential exposure to certain
chemicals in certain anadromous fish species (e.g., salmon). This
approach involves the following assumptions:
<bullet> The pollutant concentrations in anadromous fish are the
same as those in inland and nearshore fish; and
<bullet> 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 Columbia River Inter-Tribal
Fish Commission (CRITFC) \69\ data (since CRITFC data were used to
derive the 175 g/day FCR).
---------------------------------------------------------------------------

\69\ Fish Consumption Survey of the Umatilla, Nez Perce, Yakama,
and Warm Springs Tribes of the Columbia River Basin (CRITFC 1994).
---------------------------------------------------------------------------

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
an RSC of 0.2 yields 0.48, or 0.5 rounding to a single decimal place.
Because the 175 g/day 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 an RSC between 0.2 and 0.5. Criteria derived using an RSC greater
than 0.5 remained unchanged. EPA is using these same 2016 RSCs to
derive HHC for Washington in this final rule, having no new data or
information to support revising RSCs. The inclusion of protective RSCs
in the development of HHC is a science-based decision that protects
human health by ensuring that a person's exposure to multiple sources
of a chemical is accounted for. See Table 1, column B2 of this preamble
for a list of EPA's RSCs by pollutant.
Some commenters asserted that use of an RSC of 1 is scientifically
indefensible and that returning to EPA's 2016 approach of using an RSC
equal to or less than 0.8 will ensure that the HHC consider other
potential exposures. Commenters stated that tribes are regularly
exposed to toxins through other routes of exposure in addition to fish
consumption, such as dermal exposure. Commenters agreed with EPA's
statement in the proposed rule that the choice of cancer risk level
(CRL) is irrelevant to the choice of RSC since these inputs are for
mutually exclusive

[[Page 69191]]

categories of pollutants (carcinogens vs. non-carcinogens).
Other commenters asserted that the RSC value is a discretionary
risk management decision and there is no regulatory requirement to
examine multiple exposure routes when developing HHC. Commenters also
stated that the criteria are only intended to protect for risks related
to surface water exposure, i.e., fish and water. Some commenters
asserted that it is arbitrary for EPA to use an RSC less than 1 when
the FCR includes all fish. Other commenters pointed to prior EPA
actions, including EPA's 2011 HHC approval in Oregon, and EPA's 2013
approval of HHC for the Spokane Tribe, to assert that EPA has approved
HHC that rely on an RSC of 1. Finally, some commenters state that EPA's
use of RSCs in the drinking water program under the Safe Drinking Water
Act (SDWA) is different than using them for WQS since SDWA allows for
consideration of cost in setting the final regulatory limits.
As explained in the proposed rulemaking, EPA determined that
Washington's use of an RSC value of 1 to derive HHC is not based on
sound scientific rationale as it apportioned the entire ``safe'' dose
of certain chemicals to drinking water and fish consumption, ignoring
other sources of those chemicals. While EPA acknowledges the comments
indicating that it has previously approved WQS where states and
authorized tribes utilized an RSC of 1 to develop certain HHC, in those
prior actions, EPA only approved HHC that used an RSC of 1 if EPA had
not yet updated its own corresponding national recommended 304(a)
criteria to reflect chemical-specific RSC values following the Exposure
Decision Tree approached described in the 2000 Methodology. Without
updated national recommended 304(a) criteria, states and tribes did not
yet have the benefit of EPA's thorough review of exposure information
that now exists since EPA updated its national HHC recommendations in
2015. Since the 2015 recommended HHC updates, EPA has encouraged all
states to consider the latest science reflected in EPA's 2015 HHC
recommendations during the triennial review of state WQS and update
their HHC to incorporate appropriate RSCs. For detailed responses to
all comments received, see EPA's Response to Comment document in the
docket for this rule.
e. Pollutant-Specific Bioaccumulation Factors
Where data are available, EPA uses BAFs to account for the uptake
and retention of waterborne chemicals by aquatic organisms from all
surrounding media and to ensure that resulting criteria are science-
based and protect designated uses for human health. Consistent with the
2016 Federal rule for Washington,\70\ EPA is finalizing HHC for
Washington by applying the trophic level four BAF from the 2015 CWA
section 304(a) recommended HHC updates in conjunction with the 175 g/
day FCR.\71\
---------------------------------------------------------------------------

\70\ Revision of Certain Water Quality Standards Applicable to
Washington, 81 FR 85417 (November 28, 2016).
\71\ 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 used the trophic level four BAF
from the 2015 CWA section 304(a) HHC updates in conjunction with the
175 g/day FCR, in order to derive protective criteria. See Fish
Consumption Survey of the Umatilla, Nez Perce, Yakama, and Warm
Springs Tribes of the Columbia River Basin (CRITFC 1994).
---------------------------------------------------------------------------

Some commenters asserted that the choice of BCFs versus BAFs is a
science-based rather than risk management decision, and that EPA is
appropriately following the science in applying BAFs in this rule.
These commenters asserted that BCFs undercount the amount of chemicals
in fish, and EPA disregarded science and its own guidance when it
approved BCF-based HHC in 2019.
Other commenters asserted that Washington's choice to use BCFs
rather than BAFs was a sound science policy choice. These commenters
asserted that BCFs are based on sound scientific principles and state
that EPA has previously approved HHC that rely on BCFs. Commenters
asserted that EPA's national recommended BAFs are just guidance, that
they overestimate bioaccumulation and therefore lead to overly
stringent HHC, and that they are insufficiently explained such that it
is not possible to determine if they are appropriate for Washington.
Some commenters asserted that both BAFs and BCFs are influenced by the
local environment (e.g., food web structure, water temperature,
dissolved carbon) and therefore cannot be based on a single set of
assumptions for all waters.
Regarding the comments supporting the use of BCFs, as explained in
the proposed rule, the use of BCFs rather than BAFs, where BAF data are
available, to calculate the HHC is inconsistent with sound scientific
rationale on the bioaccumulation of pollutants. EPA has considered the
comments received on its selected BAFs and reiterates its explanation
in the proposed rule that it does not have new data or information to
support an alternative to its 2016 decision to use the trophic level
four BAFs, given that the species commonly consumed in Washington are
trophic level four fish (e.g., salmon). For certain pollutants for
which science-based BAFs are not currently available, EPA is finalizing
HHC using the BCFs from its updated CWA section 304(a) recommended HHC
for those pollutants as the best available scientific information. See
Table 1, columns B4 and B5 of this preamble for a list of EPA's
bioaccumulation factors by pollutant. For detailed responses to all
comments received, see EPA's Response to Comment document in the docket
for this rule.

C. Final Human Health Criteria for Washington

EPA is finalizing 141 HHC for 72 different pollutants (70 organism-
only criteria and 71 water-plus-organism criteria) to protect the
applicable designated uses of Washington's waters (see Table 1 of this
preamble). The final HHC are the same criteria that EPA promulgated in
2016. The water-plus-organism criteria in column C1 of Table 1 of this
preamble, are the applicable criteria for any waters that include the
Domestic Water use (domestic water supply) defined in Washington's WQS
(WAC 173-201A-600). The organism-only criteria in column C2 of Table 1
of this preamble, are the applicable criteria for any waters that do
not include the Domestic Water use (domestic water supply) and that
Washington defines at WAC 173-201A-600 and 173-201A-610 as the
following:
<bullet> Fresh waters--Harvesting (fish harvesting), and
Recreational Uses;
<bullet> 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.
BILLING CODE 6560-50-P

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[GRAPHIC] [TIFF OMITTED] TR18NO22.711

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[GRAPHIC] [TIFF OMITTED] TR18NO22.712

BILLING CODE 6560-50-C

D. Applicability

Under the CWA, Congress gave states primary responsibility for
developing and adopting WQS for their navigable waters (CWA section
303(a)-(c)). Although EPA is finalizing revised HHC for Washington,
Washington continues to have the option to adopt and submit to EPA
newly revised HHC for the State's waters consistent with CWA section
303(c) and EPA's implementing regulations at 40 CFR part 131. If,
subsequent to this final rule, Washington adopts and submits revised
HHC, EPA's federally promulgated criteria will remain applicable for
purposes of the CWA until EPA withdraws the federally promulgated
criteria (40 CFR 131.21(c)). EPA would undertake such a rulemaking to
withdraw the Federal criteria if and when Washington adopts and EPA
approves corresponding State criteria that meet the requirements of
section 303(c) of the CWA and EPA's implementing regulations at 40 CFR
part 131.

E. Alternative Regulatory Approaches and Implementation Mechanisms

The Federal WQS regulation at 40 CFR part 131 provides several
tools that Washington has available to use at its discretion when
implementing or deciding how to implement these HHC. Among other
things, EPA's WQS regulation: (1) specifies how states and authorized
tribes establish, modify, or remove designated uses (40 CFR 131.10);
(2) specifies the requirements for establishing criteria to protect
designated uses, including criteria modified to reflect site-specific

[[Page 69194]]

conditions (40 CFR 131.11); (3) authorizes and provides a regulatory
framework for states and authorized tribes to adopt WQS variances where
it is not feasible to attain the applicable WQS at that time (40 CFR
131.14); and (4) allows states and authorized tribes to authorize the
use of compliance schedules in National Pollutant Discharge Elimination
System (NPDES) permits to meet water quality-based effluent limits
(WQBELs) derived from the applicable WQS (40 CFR 131.15). Each of these
approaches is discussed in more detail in the next sections. Whichever
approach a state pursues, however, all NPDES permits would need to
comply with EPA's regulations at 40 CFR 122.44(d)(1)(i).
a. Designated Uses
EPA's HHC apply to waters that Washington has designated for the
following:
<bullet> Fresh waters--Harvesting (fish harvesting), Domestic Water
(domestic water supply), and Recreational Uses;
<bullet> 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).
The Federal regulation at 40 CFR 131.10(g) provides requirements
for establishing, modifying, and removing designated uses when
attaining the use is not feasible based on one of the six factors
specified in the regulation. If Washington removes a use and adopts the
highest attainable use,\72\ the State must also adopt criteria to
protect the newly designated highest attainable use consistent with 40
CFR 131.11. It is possible that criteria other than the federally
promulgated criteria would protect the highest attainable use. If EPA
found removal or modification of the designated use and the adoption of
the highest attainable use and criteria to protect that use to be
consistent with CWA section 303(c) and the implementing regulation at
40 CFR part 131, the agency would approve the revised WQS. EPA would
then undertake a rulemaking to withdraw the corresponding Federal WQS
for the relevant water(s).
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\72\ If a state or authorized tribe adopts a new or revised WQS
based on a required use attainability analysis, then it must also
adopt the highest attainable use (40 CFR 131.10(g)). The highest
attainable use is the modified aquatic life, wildlife, or recreation
use that is both closest to the uses specified in section 101(a)(2)
of the CWA and attainable, based on the evaluation of the factor(s)
in 40 CFR 131.10(g) that preclude(s) attainment of the use and any
other information or analyses that were used to evaluate
attainability. There is no required highest attainable use where the
state demonstrates the relevant use specified in section 101(a)(2)
of the Act and sub-categories of such a use are not attainable (see
40 CFR 131.3(m)).
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b. WQS Variances
Washington's WQS provide authority to apply WQS variances when
implementing federally promulgated HHC, as long as such WQS variances
are adopted consistent with 40 CFR 131.14 and submitted to EPA for
review under CWA section 303(c). The Federal regulation at 40 CFR
131.3(o) defines a WQS variance as a time-limited designated use and
criterion, for a specific pollutant or water quality parameter, that
reflects the highest attainable condition during the term of the WQS
variance. A WQS variance may be appropriate if attaining the use and
criterion would not be feasible during the term of the WQS variance
because of one of the seven factors specified in 40 CFR
131.14(b)(2)(i)(A). These factors include a situation where NPDES
permit limits more stringent than technology-based controls would
result in substantial and widespread economic and social impact. WQS
variances adopted in accordance with 40 CFR 131.14 (including a public
hearing consistent with 40 CFR 25.5) provide a flexible but defined
pathway for states and authorized tribes to issue NPDES permits with
limits that are based on the highest attainable condition during the
term of the WQS variance. This allows dischargers to make water quality
improvements when the WQS is not immediately attainable but may be in
the future. When adopting a WQS variance, states and authorized tribes
specify the interim requirements of the WQS variance by identifying a
quantitative expression that reflects the highest attainable condition
(HAC) during the term of the WQS variance, establishing the term of the
WQS variance, and describing the pollutant control activities expected
to occur over the specified term of the WQS variance. WQS variances
provide a legal avenue by which NPDES permit limits can be written to
comply with the WQS variance rather than the underlying WQS for the
term of the WQS variance. If dischargers are still unable to meet the
WQBELs derived from the applicable WQS once a WQS variance term is
complete, the regulation allows the State to adopt a subsequent WQS
variance if it is adopted consistent with 40 CFR 131.14. EPA is
finalizing HHC that apply to use designations that Washington has
already established. Washington's WQS regulations currently include
provisions to use WQS variances when implementing criteria (see WA 173-
210A-420), as long as such WQS variances are adopted consistent with 40
CFR 131.14 and approved by EPA. Washington may use the State's EPA-
approved WQS variance procedures when adopting such WQS variances.
c. NPDES Permit Compliance Schedules
EPA's regulations at 40 CFR 122.47 and 131.15 address how
permitting authorities can use schedules for compliance with a limit in
the NPDES permit if the discharger needs additional time to undertake
actions like facility upgrades or operation changes to meet a WQBEL
based on the applicable WQS. EPA's regulation at 40 CFR 122.47 allows a
permitting authority to include a compliance schedule in the NPDES
permit, when appropriate and where authorized by the state, to provide
a discharger with additional time to meet a WQBEL implementing
applicable WQS. EPA's regulation at 40 CFR 131.15 requires that a state
that intends to allow the use of NPDES permit compliance schedules
adopt specific provisions authorizing their use and obtain EPA approval
under CWA section 303(c) to ensure that a decision to allow a permit
compliance schedule is transparent and allows for public input.\73\ EPA
has approved Washington's State law provision authorizing the use of
permit compliance schedules (see WAC-173-201A-510(4)), consistent with
40 CFR 131.15. Washington's compliance schedule authorizing provision
is not affected by this rule. Washington is authorized to grant permit
compliance schedules, as appropriate, based on the Federal HHC in
Washington, if such permit compliance schedules are consistent with
EPA's permitting regulation at 40 CFR 122.47.
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\73\ 80 FR 51022 (August 21, 2015).
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IV. Economic Analysis

EPA focused its economic analysis on the potential cost impacts to
current holders of individual NPDES permits (point sources) and the
costs the State of Washington may bear to develop Total Maximum Daily
Loads (TMDLs) for waters newly identified as impaired under CWA section
303(d) using the revised WQS. Costs might also arise to holders of
general permits \74\ should the State modify those permits in some
manner as a result of the revised WQS. Costs might also arise to
sectors whose operations are nonpoint sources of pollutants through
implementation of TMDLs or through other voluntary,

[[Page 69195]]

incentivized, or State-imposed controls. This rule does not directly
regulate nonpoint sources and under the CWA states are responsible for
the regulation of nonpoint sources. EPA recognizes that controls for
nonpoint sources may be part of future TMDLs, but any such future
decisions will be made by the State. Nonpoint sources are intermittent,
variable, and occur under hydrologic or climatic conditions associated
with precipitation events. Data to model and evaluate the potential
cost impacts associated with nonpoint sources were not available and
any estimate would be too uncertain to be informative. EPA also did not
estimate potential sediment remediation costs for this analysis.
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\74\ General permits typically focus on best management
practices.
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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 criteria. This analysis is documented in
``Economic Analysis for Restoring Protective Human Health Criteria in
Washington,'' which can be found in the record for this rule. Any
NPDES-permitted facility that discharges pollutants for which the
revised HHC are more stringent than the applicable aquatic life
criteria (or for which HHC 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).

A. Identifying Affected Entities

EPA identified 406 point source facilities that could ultimately be
affected by this 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 requirements typically focus on best
management practices. Of the potentially affected facilities, EPA
evaluated a sample of 18 major facilities. Minor facilities are less
likely to incur costs as a result of implementation of the rule because
of the reduced potential for significant presence of toxic pollutants
in their effluent. 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....................................................... 169 44 213
Industrial...................................................... 164 29 193
-----------------------------------------------
Total....................................................... 333 73 406
----------------------------------------------------------------------------------------------------------------

B. Method for Estimating Costs

EPA evaluated the two major municipal facilities with design flows
greater than 100 mgd and the largest industrial facility, 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 HHC based on the rulemaking, and
potential to exceed projected effluent limitations based on the last
three years of effluent monitoring data (if available). Only compliance
actions and costs that would be needed above the baseline level of
controls are attributable to the rulemaking.
EPA assumes that dischargers would pursue the least cost means of
compliance with WQBELs. Compliance actions attributable to the
rulemaking may include pollution prevention, end-of-pipe treatment, and
alternative compliance mechanisms (e.g., WQS variances). EPA annualizes
capital costs, including study (e.g., WQS variance) and program (e.g.,
pollution prevention) costs, over 20 years using discount rates of 3
percent and 7 percent to obtain total annual costs per facility. To
obtain an estimate of total costs to point sources, EPA extrapolates
the annualized costs for the random sample based on the flow volume for
the sample facilities and the flow volume for all facilities.

C. Results

Based on the results for 18 sample facilities across 10 industrial
and municipal categories,\75\ EPA did not identify any incremental
costs to any major point source discharges of process wastewater from
POTWs or industrial facilities attributable to EPA's criteria
revisions. This does not mean that EPA anticipates there would be no
costs to point sources over time to implement controls or modify
processes to meet future permit limits, only that available data do not
indicate the immediate need for the facilities evaluated. It would be
highly speculative to attempt to estimate potential costs either based
on the possibility of measuring pollutant levels at lower levels as a
result of future requirements or future technology, or based on changes
to facility operations or practices. Should the need to consider
advanced treatment or other substantial costs arise in the future,
there are mechanisms such as WQS variances in place which may consider
cost and feasibility in the application of protective criteria, and
alternative permit limits may be derived to avoid excessive costs. EPA
will work with the State of Washington and with stakeholders on a
continuing basis to assess the possibility of economically significant
future costs of compliance. If such costs arise, EPA will provide
guidance for applying alternative compliance mechanisms to minimize
costs.
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\75\ Ten industrial categories (coal mining, food and kindred
products, paper and allied products, chemicals and allied products,
petroleum refining and related industries, primary metal industries,
fabricated metal products, electric, gas and sanitary services, and
national security and international affairs) and municipal POTWs.
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One important contributing factor to examining point source costs
is the limitations of required analytical methods to measure chemical
concentrations in effluents. Nearly half of pollutant parameters
addressed in this rule have analytical quantitation limits that are
above both the criteria currently in place and EPA's criteria. PCBs are
a good example. The current criterion in place is 170 picograms per
liter (pg/L) and EPA's criterion is 7 pg/L. However, the State
identifies the analytical detection limit for effluent measurement as
65,000 pg/L as the means to evaluate compliance. EPA has completed a
multi-laboratory validation of a new analytical method for PCBs (method
1628) that has an average analytical quantitation limit for each PCB
congener of approximately 2,000

[[Page 69196]]

pg/L, which is a substantial improvement over the current regulatory
method, but still well above either the criterion currently in place or
EPA's criterion. As a general matter, analytical methods and
quantitation limits are subject to change over time. As such, it is
important that WQS reflect the necessary level of protection regardless
of contemporary limitations of analytical methods.
EPA also evaluated potential administrative costs to the State for
developing additional TMDLs under CWA section 303(d) for any waters
that are newly identified as impaired as a result of EPA's criteria.
Using available ambient monitoring data, EPA compared pollutant
concentrations to the baseline and revised criteria, identifying
waterbodies that may be incrementally impaired (i.e., impaired under
EPA's criteria but not under the baseline). EPA identified 32
impairments under the baseline criteria and 61 under the revised
criteria, resulting in 29 potential incremental impairments. The
estimated total annual costs for TMDL development range from $100,000
to $182,000, at a 3 percent discount rate, based on single-cause
single-waterbody TMDL development costs. Actual costs may be reduced if
the State develops multi-cause or multi-waterbody TMDLs.

V. Statutory and Executive Order Reviews

Additional information about these statutes and Executive orders
can be found at <a href="https://www.epa.gov/laws-regulations/laws-and-executive-orders">https://www.epa.gov/laws-regulations/laws-and-executive-orders</a>.

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

This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

This action does not impose any new information collection burden
under the PRA. While actions to implement these WQS could entail
additional paperwork burden, this action does not directly contain any
information collection, reporting, or record-keeping requirements. OMB
has previously approved the information collection activities contained
in the existing regulation at 40 CFR part 131 and has assigned OMB
control number 2040-0049.

C. Regulatory Flexibility Act (RFA)

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. Small
entities, such as small businesses or small governmental jurisdictions,
are not directly regulated by this rule. EPA-promulgated WQS are
implemented through various water quality control programs including
the NPDES program, which limits discharges to navigable waters except
in compliance with a NPDES permit. CWA section 301(b)(1)(C) and EPA's
implementing regulations at 40 CFR 122.44(d)(1) introductory text and
(d)(1)(i) provide that all NPDES permits shall 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. While the State has
discretion in developing discharge limits, as needed to meet the WQS,
those limits, per regulations at 40 CFR 122.44(d)(1)(i), ``must control
all pollutants or pollutant parameters (either conventional,
nonconventional, or toxic pollutants) which the Director determines are
or may be discharged at a level that will cause, have the reasonable
potential to cause, or contribute to an excursion above any [s]tate
water quality standard, including [s]tate narrative criteria for water
quality.'' 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 WQS established in this 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 (UMRA)

This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local, or tribal governments or the private sector.

E. Executive Order 13132: Federalism

Under the technical requirements of Executive Order 13132, the EPA
has determined that this rule may not have federalism implications but
believes that the consultation requirements of the Executive order have
been satisfied in any event. This rule does not alter Washington's
considerable discretion in implementing these WQS, nor does it preclude
Washington from adopting WQS that EPA concludes meet the requirements
of the CWA after promulgation of this final rule.

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. 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. Additionally, there are six
federally recognized Indian tribes in the Columbia River Basin located
in the States of Oregon and Idaho that this rule could affect because
their waters could affect or be affected by the water quality of
Washington's downstream or upstream waters.
EPA consulted with tribal governments under the EPA Policy on
Consultation and Coordination with Indian Tribes early in the process
of developing this regulation to ensure meaningful and timely input
into its development. In August 2021, EPA held coordination and
consultation sessions with tribal environmental staff and leadership to
share information, hear their views and answer questions on the
rulemaking. Representatives from 17 tribes and two tribal consortia
participated in two leadership meetings with EPA held in August 2021.
Additionally, EPA conducted tribal consultation and coordination
activities on the proposed rulemaking from March 29, 2022, through June
3, 2022. During these meetings, the tribes repeatedly asked EPA to
reinstate the 2016 Federal HHC for Washington, which EPA is doing in
this final rule.
A Summary of EPA's Consultation, Coordination, and Outreach with
Federally Recognized Tribes on the Restoration of Protective Human
Heath Criteria for Washington is available in the docket for this final
rule.

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

This action is not subject to Executive Order 13045 because it is
not economically significant as defined in

[[Page 69197]]

Executive Order 12866, and because the EPA does not believe the
environmental health or safety risks addressed by this action present a
disproportionate risk to children. This action's health and risk
assessments are contained in section II.B of this preamble, in which
EPA recommends that HHC be designed to reduce 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/shellfish obtained from inland and nearshore waters. EPA's HHC for
Washington are similarly based on reducing the chronic health effects
occuring from lifetime exposure and therefore are expected to be
protective of a person's exposure during both childhood and adult
years.

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

This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866. This
action establishes CWA HHC for waters under the State of Washington's
jurisdiction.

I. National Technology Transfer and Advancement Act of 1995

This rule does not involve technical standards.

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

EPA believes that this action does not have disproportionately high
and adverse human health or environmental effects on minority
populations, low-income populations and/or Indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The
documentation for this decision is contained below.
1. Introduction
EPA defines Environmental Justice (EJ) as the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation and enforcement of environmental laws, regulations and
policies.\76\ Three Executive orders (E.O. 12898,\77\ 13985,\78\ and
14008 \79\) advance EJ by calling on Federal agencies to identify and
address disproportionate impacts on historically underserved,
marginalized, and economically disadvantaged people. Additionally, EPA
has expressed a commitment to conducting EJ analyses for rulemakings as
described in the April 30, 2021, revisions to the Cross-State Air
Pollution Rule (CSAPR).\80\
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\76\ Fair treatment means that ``no group of people should bear
a disproportionate burden of environmental harms and risks,
including those resulting from the negative environmental
consequences of industrial, governmental and commercial operations
or programs and policies.'' Meaningful involvement occurs when ``(1)
potentially affected populations have an appropriate opportunity to
participate in decisions about a proposed activity [e.g.,
rulemaking] that will affect their environment and/or health; (2)
the public's contribution can influence [the EPA's rulemaking]
decision; (3) the concerns of all participants involved will be
considered in the decision-making process; and (4) [the EPA will]
seek out and facilitate the involvement of those potentially
affected.'' A potential EJ concern is defined as ``the actual or
potential lack of fair treatment or meaningful involvement of
minority populations, low-income populations, tribes, and tribal
peoples in the development, implementation and enforcement of
environmental laws, regulations and policies.'' See ``Guidance on
Considering Environmental Justice During the Development of an
Action,'' Environmental Protection Agency, <a href="http://www.epa.gov/environmentaljustice/guidanceconsidering-environmental-justice-duringdevelopment-action">www.epa.gov/environmentaljustice/guidanceconsidering-environmental-justice-duringdevelopment-action</a>. See also <a href="https://www.epa.gov/environmentaljustice">https://www.epa.gov/environmentaljustice</a>.
\77\ Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations. Available at
<a href="https://www.epa.gov/environmentaljustice/federal-actions-address-environmental-justice-minority-populations-and-low">https://www.epa.gov/environmentaljustice/federal-actions-address-environmental-justice-minority-populations-and-low</a>, accessed October
6, 2021.
\78\ Advancing Racial Equity and Support for Underserved
Communities Through the Federal Government (86 FR 7009, January 25,
2021). Available at <a href="https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government">https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government</a>, accessed
October 6, 2021.
\79\ Tackling the Climate Crisis at Home and Abroad (86 FR 7619,
February 1, 2021). Available at <a href="https://www.federalregister.gov/documents/2021/02/01/2021-02177/tackling-the-climate-crisis-at-home-and-abroad">https://www.federalregister.gov/documents/2021/02/01/2021-02177/tackling-the-climate-crisis-at-home-and-abroad</a>, accessed October 6, 2021.
\80\ 86 FR 23054, 23162 (April 30, 2021) (``Going forward, EPA
is committed to conducting environmental justice analysis for
rulemakings based on a framework similar to what is outlined here,
in addition to investigating ways to further weave environmental
justice into the fabric of the rulemaking process including through
enhanced meaningful engagement with environmental justice
communities.'').
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EPA believes that this rule is not expected to have
disproportionately high and adverse human health or environmental
effects on low-income populations, people of color, or tribal
populations, as specified in Executive Order 12898 (59 FR 7629,
February 16, 1994). In its economic impact analysis, EPA only estimates
administrative costs to the State of Washington to develop TMDLs and no
incremental costs to point source discharges based on available data,
as explained above in section IV of this preamble. Therefore, EPA does
not anticipate that this rule will impose any additional costs or other
negative impacts on tribes or other low income or disadvantaged
communities.
Instead, this action identifies and ameliorates disproportionately
high and adverse human health effects on tribal communities, people of
color and low-income populations in Washington by restoring HHC in
Washington that are based on sound scientific rationale and protect
high fish consumers.
Many groups in Washington, such as Asian, Pacific Islanders, and
subsistence and recreational tribal and non-tribal fishers consume
large amounts of fish and shellfish as part of traditionally influenced
diets.\81\ The 2019 Reconsidered HHC currently expose these high fish
consumers to greater risk from toxic pollutants because the criteria do
not accurately account for pollutant bioaccumulation into fish and
expose fish consumers to a greater risk of cancer from PCB exposure.
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\81\ Department of Ecology. Fish Consumption Rates: Technical
Support Document, A Review of Data and Information about Fish
Consumption in Washington, Version 2.0 Final. January 2013. Ecology
Publication No. 12-09-058, p.18. <a href="https://apps.ecology.wa.gov/publications/documents/1209058.pdf">https://apps.ecology.wa.gov/publications/documents/1209058.pdf</a>.
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Environmental impacts to tribes may be considered under the
category of EJ in recognition that tribes may at times be among the
disadvantaged communities disproportionately impacted by environmental
degradation. Where tribal communities are part of a larger non-tribal
community, many of the EJ considerations are very similar to those of
other disadvantaged groups. However, there is a very unique set of EJ
considerations for tribes, particularly in this context where tribes
are exercising their cultural practices and treaty-reserved rights
outside of their reservations on state waters.
While the overall impacts to communities with EJ concerns are
improved as a result of this rule, by relying on the fish consumption
rates based on tribal data, this rule helps ensure that tribal members,
in particular, and their treaty-protected activities and resources are
protected.\82\ Specifically, this rule establishes HHC based on an FCR
of 175 g/day reflective of regional tribal FCR survey data \83\ to
represent and protect higher fish consumers. In conjunction with the
FCR, the rule uses a CRL of 10-6 to

[[Page 69198]]

derive HHC for all cancer-causing pollutants, including PCBs, a rate
which is protective of tribal members exercising their legal right to
harvest and consume fish and shellfish at the 175 g/day level.
---------------------------------------------------------------------------

\82\ 80 FR 55063 (September 14, 2015) (``In Washington, many
tribes hold reserved rights to take fish for subsistence,
ceremonial, religious, and commercial purposes, including treaty-
reserved rights to fish at all usual and accustomed fishing grounds
and stations in waters under state jurisdiction, which cover the
majority of waters in the state. Such rights include not only a
right to take those fish, but necessarily include an attendant right
to not be exposed to unacceptable health risks by consuming those
fish.'').
\83\ Fish Consumption Survey of the Umatilla, Nez Perce, Yakama,
and Warm Springs Tribes of the Columbia River Basin (CRITFC 1994).
---------------------------------------------------------------------------

Central to working with tribes on their environmental issues and
opportunities is government to government consultation, which is
consistent with Executive Order 13175 (65 FR 67249, November 6, 2000).
To ensure that this rule considers the interests and perspective of
tribes, EPA engaged with tribes that may be affected by this action to
receive meaningful and timely input from tribal officials. See section
V.F of this preamble for a summary of tribal consultation.
In addition to Executive Orders 12898 and 13175, and in accordance
with Title VI of the Civil Rights Act of 1964, each Federal agency
shall ensure that all programs or activities receiving Federal
financial assistance that affect human health or the environment do not
directly, or through contractual or other arrangements, use criteria,
methods, or practices that discriminate on the basis of race, color, or
national origin. With that directive in mind, in August 2011 the
Environmental Justice Interagency Working Group established a Title VI
Committee to address the intersection of agencies' environmental
justice efforts with their Title VI enforcement and compliance
responsibilities. If Washington receives Federal funds for CWA
implementation, they are legally prohibited from discriminating on the
basis of race, color or national origin under Title VI when engaging in
CWA implementation activities. Additionally, and in compliance with
Executive Order 12898, EPA expects that Washington will consider
disproportionately high adverse human health and environmental effects
on minority and low-income populations when implementing this rule
under the CWA.

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.

Michael S. Regan,
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

0
2. Amend Sec. 131.45 by revising paragraph (b) to read as follows:

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

* * * * *
(b) Criteria for priority toxic pollutants in Washington. The
applicable human health criteria are shown in table 1 to this paragraph
(b).
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* * * * *
[FR Doc. 2022-25150 Filed 11-17-22; 8:45 am]
BILLING CODE 6560-50-C

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