[Federal Register Volume 87, Number 63 (Friday, April 1, 2022)]
[Proposed Rules]
[Pages 19046-19063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06879]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[EPA-HQ-OW-2015-0174; FRL-7253.1-01-OW]
RIN 2040-AG21


Restoring Protective Human Health Criteria in Washington

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) has determined that 
Washington's human health criteria (HHC) are not protective of 
Washington's designated uses and are not based on sound scientific 
rationale and, accordingly, is proposing to restore protective HHC for 
Washington's waters. EPA partially approved and partially disapproved 
Washington's HHC in November 2016, and simultaneously promulgated 
federal HHC based on sound scientific rationale. In May 2019, EPA 
reversed its November 2016 disapproval and approved Washington's HHC, 
and in June 2020 withdrew the 2016 HHC that EPA promulgated for 
Washington. Based on the best scientific information and analyses 
currently available, and consideration of these past decisions, EPA has 
concluded that Washington's existing HHC are not based on sound 
scientific rationale and are therefore not protective of the applicable 
designated uses in Washington. EPA is therefore proposing to reinstate 
the protective and science-based federal HHC that EPA withdrew in June 
2020 to protect Washington's waters, including waters where tribes hold 
treaty-reserved rights to fish.

DATES: Comments must be received on or before May 31, 2022. Public 
Hearing: EPA will hold two public hearings during the public comment 
period. Please refer to the SUPPLEMENTARY INFORMATION section for 
additional information on the public hearings.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OW-2015-0174, by any of the following methods:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov/ 
(our preferred method). Follow the online instructions for submitting 
comments.
    <bullet> Mail: U.S. Environmental Protection Agency, EPA Docket 
Center, Standards and Health Protection Division Docket, Mail Code 
28221T, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
    <bullet> Hand Delivery or Courier (by scheduled appointment only): 
EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution 
Avenue NW, Washington, DC 20004. The Docket Center's hours of 
operations are 8:30 a.m.-4:30 p.m., Monday-Friday (except Federal 
holidays).
    Instructions: All submissions received must include the Docket ID 
No. EPA-HQ-OW-2015-0174 for this rulemaking. Comments received may be 
posted without change to https://www.regulations.gov/, including any 
personal information provided. For detailed instructions on sending 
comments and additional information on the rulemaking process, see the 
``Public Participation'' heading of the SUPPLEMENTARY INFORMATION 
section of this document. Out of an abundance of caution for members of 
the public and our staff, the EPA Docket Center and Reading Room are 
open to the public by appointment only, to reduce the risk of 
transmitting COVID-19. Our Docket Center staff also continues to 
provide remote customer service via email, phone, and webform. Hand 
deliveries and couriers may be received by scheduled appointment only. 
For further information on EPA Docket Center services and the current 
status, please visit us online at https://www.epa.gov/dockets.
    EPA is offering two public hearings on this proposed rulemaking. 
Refer to the SUPPLEMENTARY INFORMATION section below for additional 
information.

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#23454f464a504a440d46514a4042634653420d444c55"><span class="__cf_email__" data-cfemail="086e646d617b616f266d7a616b69486d7869266f677e">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: This proposed rulemaking is organized as 
follows:
I. Public Participation
    A. Written Comments
    B. Public Hearings
II. General Information
    A. Does this action apply to me?
III. Background
    A. Statutory and Regulatory Background
    B. General Recommended Approach for Deriving Human Health 
Criteria
    C. Prior EPA Actions Related to Washington's Human Health 
Criteria
IV. Administrator's Determination That New or Revised HHC are 
Necessary for Washington
    A. Existing Criteria Are Not Protective of Designated Uses of 
Waters in the State of Washington
    B. Clean Water Act 303(c)(4)(B) Administrator's Determination
V. Derivation of Human Health Criteria for Washington
    A. Scope of EPA's Proposal
    B. Washington-Specific Human Health Criteria Inputs
    C. Proposed Human Health Criteria for Washington
    D. Applicability
    E. Alternative Regulatory Approaches and Implementation 
Mechanisms
VI. Economic Analysis
    A. Identifying Affected Entities
    B. Method for Estimating Costs to Point Sources
    C. Results
VII. 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

[[Page 19047]]

    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From 
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act of 1995
    J. Executive Order 12898: Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations

I. Public Participation

A. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2015-
0174, at https://www.regulations.gov (our preferred method), or the 
other methods identified in the ADDRESSES section. Once submitted, 
comments cannot be edited or removed from the docket. EPA may publish 
any comment received to its public docket. Do not submit to EPA's 
docket at https://www.regulations.gov any information you consider to 
be Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Multimedia submissions (audio, 
video, etc.) must be accompanied by a written comment. The written 
comment is considered the official comment and should include 
discussion of all points you wish to make. EPA will generally not 
consider comments or comment contents located outside of the primary 
submission (i.e., on the web, cloud, or other file sharing system). For 
additional submission methods, the full EPA public comment policy, 
information about CBI or multimedia submissions, and general guidance 
on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    Due to public health concerns related to COVID-19, the EPA Docket 
Center and Reading Room are open to the public by appointment only. Our 
Docket Center staff also continues to provide remote customer service 
via email, phone, and webform. Hand deliveries or couriers will be 
received by scheduled appointment only. For further information and 
updates on EPA Docket Center services, please visit us online at 
https://www.epa.gov/dockets.
    EPA continues to carefully and continuously monitor information 
from the Centers for Disease Control and Prevention (CDC), local area 
health departments, and our federal partners so that we can respond 
rapidly as conditions change regarding COVID-19.

B. Public Hearings

    Please note that because of current CDC recommendations, as well as 
state and local orders for social distancing to limit the spread of 
COVID-19, EPA cannot hold in-person public meetings at this time. EPA 
is offering two online public hearings so that interested parties may 
also provide oral comments on this proposed rulemaking. For more 
details on the online public hearings and to register to attend the 
hearings, please visit https://www.epa.gov/wqs-tech/federal-human-health-criteria-washington-state-waters.

II. 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) in this rulemaking, once 
finalized, will be the 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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                                      Examples of potentially affected
             Category                             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 Districts...  Entities responsible for managing
                                     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.

III. 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.\1\
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    \1\ USEPA. 2000. Memorandum 1BWQSP-00-03. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC. https://www.epa.gov/sites/production/files/2015-01/documents/standards-shellfish.pdf.
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    Consistent with the CWA, EPA's WQS program assigns to states and 
authorized tribes the primary authority for adopting WQS.\2\ 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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    \2\ 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

[[Page 19048]]

with CWA Section 303(c).\3\ 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 to determine ``that a revised or new 
standard is necessary to meet the requirements of [the Act].'' \4\ 
After making such a determination, known as an Administrator's 
Determination,\5\ the agency must ``promptly'' propose an appropriate 
WQS and finalize it within ninety days unless the state adopts an 
acceptable standard in the interim.\6\
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    \3\ 33 U.S.C. 1313(c)(2)(A), (c)(3).
    \4\ Id. at (c)(4)(B).
    \5\ 40 CFR 131.22(b)
    \6\ 33 U.S.C. 1313(c)(4)(B).
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B. General Recommended Approach for Deriving Human Health Criteria

    EPA's 2000 Methodology for Deriving Ambient Water Quality Criteria 
for the Protection of Human Health \7\ (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. 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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    \7\ USEPA. 2000. Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf.
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    As discussed in EPA's 2000 Methodology, EPA recommends basing HHC 
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 recommends the 
lower (i.e., more stringent) value. Under the 2000 Methodology, HHC for 
carcinogenic effects are calculated 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). HHC for both non-cancer and nonlinear 
carcinogenic effects are calculated using a reference dose (RfD) and 
relative source contribution (RSC) in place of a CSF and CRL. 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 III.B.a through 
III.B.d of this preamble and in EPA's 2000 Methodology.\8\
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    \8\ Id.
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a. Cancer Risk Level
    EPA's 2000 Methodology 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 CWA Section 304(a) national 
recommended HHC for carcinogenic effects as pollutant concentrations 
corresponding to lifetime increases in the risk of developing cancer. 
EPA calculates its CWA Section 304(a) national recommended HHC values 
at a 10<SUP>-</SUP>\6\ (one in one million) CRL and recommends CRLs of 
10<SUP>-</SUP>\6\ or 10<SUP>-</SUP>\5\ (one in one hundred thousand) 
for the general population.\9\ EPA notes that states and authorized 
tribes can also choose a more stringent risk level, such as 
10<SUP>-</SUP>\7\ (one in ten million), when deriving HHC.
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    \9\ EPA's 2000 Methodology also states: ``Criteria based on a 
10<SUP>-</SUP>\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<SUP>-</SUP>\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 CWA Section 304(a) national recommended 
HHC, EPA's Integrated Risk Information System (IRIS) \10\ was the 
source of both cancer and noncancer toxicity values (i.e., RfD and 
CSF).\11\ 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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    \10\ USEPA. Integrated Risk Information System (IRIS). U.S. 
Environmental Protection Agency, Office of Research and Development, 
Washington, DC. www.epa.gov/iris.
    \11\ Final Updated Ambient Water Quality Criteria for the 
Protection of Human Health, (80 FR 36986, June 29, 2015). See also: 
USEPA. 2015. Final 2015 Updated National Recommended Human Health 
Criteria. U.S. Environmental Protection Agency, Office of Water, 
Washington, DC. https://www.epa.gov/wqc/human-health-water-quality-criteria.
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c. Exposure Assumptions
    In the 2000 Methodology, EPA states that its assumptions ``afford 
an overall level of protection targeted at the high end of the general 
population.'' Toward this end, 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. Per EPA's latest CWA Section 304(a) national 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

[[Page 19049]]

at the 90th percentile for adults ages 21 and older.\12\ 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.<SUP>13 14</SUP> EPA calculates its CWA Section 304(a) national 
recommended 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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    \12\ USEPA. 2011. EPA Exposure Factors Handbook. 2011 edition 
(EPA 600/R-090/052F). http://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=236252.
    \13\ 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.
    \14\ 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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    One reason EPA has determined that a subset of Washington's 2016 
HHC are inadequate is due to their reliance on bioconcentration factors 
(BCFs) rather than BAFs. To provide background for our discussion 
below, the history of the agency's use of BCFs and BAFs is reviewed 
here. 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,\15\ 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 concluded that ``[f]or highly persistent and 
bioaccumulative chemicals that are not easily metabolized, BCFs do not 
reflect what the science indicates.'' \16\ EPA's 2000 Methodology 
emphasizes using, 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.\17\ This BAF-based approach includes separate 
procedures to be used according to the physicochemical properties of 
the chemical. Separate BAFs for each trophic level are derived to 
account for potential biomagnification of chemicals in aquatic food 
webs, as well as physiological differences among organisms that may 
affect bioaccumulation.\18\
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    \15\ USEPA. 2000. Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf 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.'').
    \16\ 65 FR 66444 November 3, 2000.
    \17\ USEPA. 2000. Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf.
    \18\ 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. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf.
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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.\19\ 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) 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.\20\ 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.\21\
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    \19\ 65 FR 66444 November 3, 2000.
    \20\ Final Updated Ambient Water Quality Criteria for the 
Protection of Human Health, (80 FR 36986, June 29, 2015). See also: 
USEPA. 2015. Final 2015 Updated National Recommended Human Health 
Criteria. U.S. Environmental Protection Agency, Office of Water, 
Washington, DC. https://www.epa.gov/wqc/human-health-water-quality-criteria.
    \21\ Id.
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    Although EPA uses national default exposure-related input values to 
calculate CWA Section 304(a) national 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.\22\ EPA also recommends, where 
sufficient data are available, selecting a FCR that reflects 
consumption that is not suppressed by fish availability or concerns 
about the safety of available fish.\23\ 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 a 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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    \22\ USEPA. 2000. Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf.
    \23\ 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 https://www.epa.gov/sites/default/files/2015-02/documents/fish-consump-report_1102.pdf.

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[[Page 19050]]

d. Relative Source Contribution
    The inclusion of an RSC factor \24\ is important for protecting 
public health. When deriving HHC for non-carcinogens and nonlinear 
carcinogens, EPA recommends including an RSC factor to account for 
sources of exposure other than drinking water and consumption of fish 
and shellfish from inland and nearshore waters. These other sources of 
exposure include 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 and helps prevent 
adverse health effects from exposure to a given chemical over a 
person's lifetime. EPA's guidance \25\ 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 V.B.d of this 
preamble, EPA made science-based adjustments to the application of the 
RSC in this proposed rulemaking to avoid ``double counting'' exposures. 
Washington's failure to make such adjustments is another reason for 
EPA's finding that its HHC are inadequate.
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    \24\ ``[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.'' https://www.epa.gov/wqs-tech/supplemental-module-human-health-ambient-water-quality-criteria.
    \25\ 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.\26\ In 
that proposal, EPA explained that the majority of waters under 
Washington's jurisdiction are subject to tribal treaty-reserved fishing 
rights.\27\ 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.'' \28\ 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 a 
FCR of 175 g/day and CRL of 10<SUP>-</SUP>\6\ to reflect consideration 
of tribal treaty-reserved rights, as informed by consultation with the 
tribes and fish consumption surveys of tribal members.\29\ In addition 
to a 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 science. 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) criteria updates.\30\ EPA's approach to deriving HHC using these 
inputs is described further in section III.B. of this preamble.
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    \26\ 80 FR 55,063 (September 14, 2015).
    \27\ Id. at 55,067.
    \28\ Id.
    \29\ Id. at 55,067-68.
    \30\ Id. at 55,068-69.
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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<SUP>-</SUP>\6\ CRL that EPA 
used to derive the proposed federal HHC, with the exception of the CRL 
for polychlorinated biphenyls (PCBs).\31\ Although Washington used the 
same FCR and CRL as EPA, because WA's HHC did not use BAFs and used an 
RSC of 1, the resulting HHC for the majority of pollutants were less 
stringent than the HHC in EPA's proposed rulemaking.
---------------------------------------------------------------------------

    \31\ For PCBs, Washington's criteria were based on a chemical-
specific CRL of 2.3 x 10<SUP>-</SUP>\5\.
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    On November 15, 2016, EPA partially approved and partially 
disapproved Washington's HHC.\32\ For the criteria that were 
disapproved, EPA concurrently signed a final rule promulgating the 
Federal criteria it had proposed in 2015.\33\ 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.\34\ 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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    \32\ 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).
    \33\ 81 FR 85417, November 28, 2016.
    \34\ 81 FR 85422-27, November 28, 2016.
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    As explained further in section IV.A of this preamble, EPA's 
disapproval of Washington's HHC 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).'' \35\ 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.\36\ 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

[[Page 19051]]

protective of the State's designated uses.\37\
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    \35\ 2016 Partial Approval/Disapproval at 3.
    \36\ Id. at 16-17.
    \37\ 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).'' \38\ 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 
scientifically defensible criteria that the EPA determined would be 
protective of Washington's designated uses.\39\ Accordingly, EPA 
approved those criteria.\40\
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    \38\ Id. at 8.
    \39\ Id.
    \40\ 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 promulgation of Federal 
criteria.\41\ 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.\42\
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    \41\ 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.
    \42\ 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).
---------------------------------------------------------------------------

    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 of certain HHC and subsequently issuing a 
final rule withdrawing the federally promulgated criteria.\43\ EPA's 
May 10, 2019 approval concluded that the State's reliance on scientific 
inputs that were no longer reflective of the latest science was an 
appropriate risk-management decision.\44\ The withdrawal of the federal 
rule 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.
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    \43\ 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).
    \44\ 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.\45\ 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.\46\ 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.
---------------------------------------------------------------------------

    \45\ State of Washington v. U.S. Envt'l Prot. Agency, No. 2:19-
cv-884-RAJ (W.D. Wash.).
    \46\ 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,\47\ 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.
---------------------------------------------------------------------------

    \47\ 86 FR 7037 (January 25, 2021).
---------------------------------------------------------------------------

IV. Administrator's Determination That New or Revised HHC are Necessary 
for Washington

    For the reasons explained below in section IV.A of this preamble, 
EPA has concluded that the Washington HHC that EPA disapproved in 2016 
and later approved in 2019 (the ``2019 Reconsidered HHC'') \48\ are not 
based on sound scientific rationale and are therefore not protective of 
the applicable designated uses in Washington. Accordingly, as set forth 
in section IV.B of this preamble, the Administrator has determined 
pursuant to CWA Section 303(c)(4)(B) that revised HHC are necessary. 
Pursuant to the authority of CWA Section 303(c)(4)(B), EPA is proposing 
new standards for Washington waters, as set forth in section V of this 
preamble.
---------------------------------------------------------------------------

    \48\ EPA disapproved 143 of Washington's HHC in 2016. In 2019, 
EPA reversed its disapproval of 141 of those HHC, leaving its 
disapproval of the two HHC for arsenic in place. This rule addresses 
the 141 HHC that EPA reversed its decision on in 2019.
---------------------------------------------------------------------------

    The agency's determination and its decision to issue the proposed 
rulemaking are based on application of the CWA and EPA's regulations to 
the facts before the agency at this time. In reaching the conclusions 
supporting these decisions, the agency has also carefully evaluated its 
2016 and 2019 actions on the State's criteria.

A. Existing Criteria Are Not Protective of Designated Uses of Waters in 
the State of Washington

    EPA has determined that the 2019 Reconsidered HHC do not protect 
designated uses because the input values on which they rely are not 
supported by a sound scientific rationale. We review each of those 
input values--namely an RSC value of 1, BCFs, and a CRL of 2.3 x 10\5\ 
for PCBs--in turn.
    1. RSC Value: Washington's use of an RSC value of 1 to derive HHC 
is not based on sound scientific rationale as it apportions the entire 
``safe'' dose of certain chemicals to drinking water and fish 
consumption, ignoring exposures to other sources of those chemicals. As 
discussed in section III.B above of this preamble, other sources of 
exposure include consumption of ocean fish and other foods (e.g., 
fruits, vegetables, grains, meats, poultry), dermal exposure, and 
inhalation exposure, and other routes. Washington's use of an RSC of 1 
to derive its criteria is based on the flawed assumption that 100% of 
human exposure to a pollutant is from fish and drinking water from 
waters that are subject to the State's WQS. Because humans are exposed 
to pollutants

[[Page 19052]]

through other sources of exposure, this assumption is scientifically 
unsound.
    EPA has considered the statements made by the agency in its 2019 
approval of Washington's HHC. In that approval, the agency concluded 
that the RSC value should be ``evaluated . . . in the context of the 
overall HHC package,'' noting that Washington used other 
``conservative'' inputs such as a FCR of 175 g/day and a 10\-6\ 
CRL.\49\ After careful review, the agency concludes that this rationale 
does not reasonably support the conclusion that the State's criteria 
protect the designated uses and are based on sound scientific 
rationale.
---------------------------------------------------------------------------

    \49\ May 10, 2019 letter at p. 19.
---------------------------------------------------------------------------

    First, the CRL utilized by the State is irrelevant to evaluating 
the reasonableness of the State's RSC because the CRL and RSC are 
inputs for derivation of criteria for mutually exclusive categories of 
pollutants: the CRL is an input for deriving criteria for carcinogens, 
whereas the RSC is an input for deriving criteria for non-carcinogens. 
Therefore, the CRL cannot offset or compensate for the health risk 
associated with the State's use of an RSC which assumes that 100% of 
human exposure to pollutants is from waters covered by the criteria.
    Second, while the State's use of a FCR of 175 g/day more accurately 
represented Washington fish consumers than the prior FCR of 6.5 g/day, 
that revision did not take into account risks associated with other 
routes of exposure. Given the lack of any other criteria derivation 
components that implicitly or explicitly account for other sources of 
exposure discussed above, the agency concludes that the State's use of 
an RSC which ignores other sources does not protect designated uses and 
is not based on sound scientific rationale.
    When Washington submitted its criteria in 2016, it asserted that 
its RSC choice was informed, in part, by the conclusion that the CWA 
has limited ability to control sources outside of its jurisdiction 
(i.e., in non-water media).\50\ The agency has considered the State's 
assertions and concludes that they do not support the conclusion that 
the State's criteria protect designated uses and are based on sound 
scientific rationale. First, as a factual matter, several of the other 
pollutant exposure routes that the RSC is intended to account for 
(e.g., dermal exposure, inhalation) are impacted by water quality.\51\ 
Second, and more fundamentally, EPA's longstanding approach to 
determining whether water quality criteria protect human health 
considers the totality of exposure which can contribute to adverse 
health effects. Even if the CWA does not provide a vehicle for 
addressing other sources of exposure, the protection of public health 
requires that those sources be accounted for when HHC are established. 
In the agency's judgment, this approach to deriving criteria is 
consistent with and advances the CWA's directive that WQS ``shall be as 
such to protect the public health or welfare'' (CWA Section 
303(c)(2)(A)).
---------------------------------------------------------------------------

    \50\ May 10, 2019 letter at pp. 16-17; see Department of 
Ecology. Washington State Water Quality: Human health criteria and 
implementation tools, Overview of key decisions in rule amendment. 
August 2016. Ecology Publication No. 16-10-025, p. 37. https://fortress.wa.gov/ecy/publications/documents/1610025.pdf (``The use of 
an RSC to compensate for sources of exposure outside the scope of 
the Clean Water Act when establishing HHC is a risk management 
decision that states need to carefully weigh. If the scope of the 
Clean Water Act is limited to addressing potential exposures from 
NPDES- or other Clean Water Act regulated discharges to surface 
water, it could be argued that an RSC of less than 1.0 
inappropriately expands of the scope of what the Clean Water Act 
would be expected to control.'').
    \51\ From p. 4-16 of the 2000 Methodology: ``A number of 
drinking water contaminants are volatile and thus diffuse from water 
into the air where they may be inhaled. In addition, drinking water 
is used for bathing and, thus, there is at least the possibility 
that some contaminants in water may be dermally absorbed. 
Volatilization may increase exposure via inhalation and decrease 
exposure via ingestion and dermal absorption. The net effect of 
volatilization and dermal absorption upon total exposure to volatile 
drinking water contaminants is unclear in some cases and varies from 
chemical to chemical. Dermal exposures are also important to 
consider for certain population groups, such as children and other 
groups with high soil contact.''
---------------------------------------------------------------------------

    Accordingly, since 2000, EPA has recognized the need to account for 
contributions from other sources to ensure protection of individuals 
whose exposure could be greater than indicated by currently available 
data about exposures from drinking water and freshwater and estuarine 
fish consumption. The 2000 Methodology recommends that states account 
for unknown sources of exposure and additional potential exposures to 
unknown levels from other sources, such as ocean fish consumption, food 
consumption other than fish, respiratory exposure, and/or dermal 
exposure. While states can and do make risk management choices in 
developing criteria, using an RSC value that allocates the entirety of 
exposure to a subset of specific pathways directly addressed in 
criteria derivation inappropriately disregards the risks from other 
exposure routes. In deriving water quality criteria to protect human 
health, an appropriate exercise of risk management discretion would be 
to make any necessary adjustments to the pollutant-specific RSCs to 
account for state-specific or pollutant-specific information about 
other exposure routes. EPA's 2019 decision reversing our 2016 
disapproval of a subset of Washington's HHC rested in part on a 
conclusion that the disapproval was based solely on Washington's 
failure to follow EPA's guidance in setting the RSC.\52\ To be clear, 
EPA's guidance informs, but does not dictate, EPA's implementation of 
applicable statutory and regulatory requirements. Regarding RSC, the 
guidance recognizes the indisputable fact that exposure to pollutants 
through routes other than fish consumption can contribute to adverse 
impacts on human health and therefore need to be considered to ensure 
that criteria are scientifically sound and protect designated uses, as 
required by EPA's regulations. EPA's determination in this respect 
rests on the fact that the State's RSC ignores entirely those other 
routes of exposure.
---------------------------------------------------------------------------

    \52\ For example, the 2019 decision states that the disapproval 
decision ``appears to treat the 304(a) recommendation to use an RSC 
range of 0.2-0.8 as a requirement'' and also relied on a Frequently 
Asked Questions document that ``does not have the force and effect 
of law.''
---------------------------------------------------------------------------

    As explained in section V below of this preamble, EPA followed the 
recommended approach in EPA's 2015 CWA Section 304(a) national 
recommended HHC to derive the water quality criteria in the proposed 
rulemaking, as well as in the final rule for Washington in 2016. We 
have applied pollutant-specific RSC values of less than or equal to 0.8 
for all non-carcinogens and nonlinear carcinogens.\53\ Attributing 80% 
or less of exposure to drinking water or fish consumption (i.e., using 
an RSC value less than or equal to 0.8) ensures that an individual's 
total exposure to a contaminant does not exceed the RfD of non-
carcinogenic and nonlinear carcinogenic chemicals.
---------------------------------------------------------------------------

    \53\ Final Updated Ambient Water Quality Criteria for the 
Protection of Human Health, (80 FR 36986, June 29, 2015). See also: 
USEPA. 2015. Final 2015 Updated National Recommended Human Health 
Criteria. U.S. Environmental Protection Agency, Office of Water, 
Washington, DC. https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------

    2. Use of Bioconcentration Factors (BCFs) instead of 
Bioaccumulation Factors (BAFs): Washington used BCFs rather than BAFs 
to calculate its HHC, despite the availability of data to derive BAFs 
and EPA's default recommended BAFs. 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. As 
noted in section III.B.c of this preamble, BAFs account for the 
multiple pathways for bioaccumulation of a contaminant in an

[[Page 19053]]

aquatic organism. BCFs only account for accumulation of a contaminant 
through water, whereas BAFs account for bioaccumulation through food, 
sediment, and water. As a result, the magnitude of bioaccumulation by 
aquatic organisms of certain chemicals can be substantially greater 
than the magnitude of bioconcentration absorbed solely from water. 
Using BCFs alone can therefore underestimate the extent of chemical 
accumulation in aquatic organisms, and can, in turn, affect human 
health through harmful exposure through fish and shellfish consumption. 
When data to derive BAFs are unavailable or inconclusive, it may be 
necessary to use BCFs to provide some approximation of pollutant uptake 
in aquatic organisms. Washington did have the data needed for the 
pollutants at issue here. Rather than use EPA's national recommended 
default BAFs or develop State-specific BAFs, Washington used decades-
old national default BCFs that were recommended prior to the 
development of its current national default recommended BAFs, which are 
available for states to use in the absence of local data. Thus, because 
the 2019 Reconsidered HHC are based on BCFs even where scientifically 
defensible BAFs are available, they are insufficiently protective of 
Washington's designated uses and therefore do not meet the requirements 
of the CWA.
    When EPA approved Washington's HHC in 2019, the agency acknowledged 
that Washington had spent several years engaging with stakeholders to 
develop its HHC. EPA's 2019 approval asserted that Washington ``was 
preparing to finalize its proposed HHC based on the EPA's prior 
recommended BCFs, not the new national default BAFs.'' \54\ Because of 
that timing, in 2019 EPA determined that Washington's failure to 
incorporate BAFs was not a reason for disapproval.
---------------------------------------------------------------------------

    \54\ May 10, 2019 letter at p. 16.
---------------------------------------------------------------------------

    EPA has determined that rationale was not well grounded then and 
should not apply now. As discussed above in section III.B.c. of this 
preamble, EPA began recommending the use of BAFs, rather than BCFs, in 
its 2000 Methodology, 15 years prior to its issuance of revised 
criteria recommendations in 2015. Furthermore, Washington was aware of 
the agency's scientific judgment that BAFs more accurately reflect the 
total uptake of a chemical.\55\ The 2015 CWA Section 304(a) 
recommendations included pollutant-specific national default BAFs for 
states and authorized tribes to rely on. Even in the absence of these 
national default BAFs, states could still develop their own BAFs 
following EPA's 2000 Methodology. Therefore, not only was Washington 
aware of the science supporting the importance of using BAFs, it also 
had the opportunity to develop its own BAFs prior to developing its 
revised HHC and sufficient notice of EPA's nationally recommended 
pollutant-specific default BAFs.
---------------------------------------------------------------------------

    \55\ Department of Ecology. Washington State Water Quality: 
Human health criteria and implementation tools, Overview of key 
decisions in rule amendment. August 2016. Ecology Publication No. 
16-10-025, pp. 46-49. https://fortress.wa.gov/ecy/publications/documents/1610025.pdf.
---------------------------------------------------------------------------

    In approving Washington's criteria relying on BCFs in 2019, EPA 
also emphasized consideration of the State's prerogative to make its 
own risk-management decisions. This rationale improperly accepted 
Washington's justifications for its use of BCFs as ``risk management'' 
decisions.\56\ Washington gave four reasons for using BCFs (1) BCFs are 
more closely related to the environmental media (water) that is 
regulated under the CWA; (2) BCFs do not include as many inputs and 
predictions based on national datasets that may not be reflective of 
Washington's waters; (3) BCFs have fewer inputs and less uncertainty; 
and (4) relying on BCFs alone is acceptable under the CWA for criteria 
development.\57\
---------------------------------------------------------------------------

    \56\ May 10, 2019 letter at p. 17.
    \57\ Department of Ecology. Washington State Water Quality: 
Human health criteria and implementation tools, Overview of key 
decisions in rule amendment. August 2016. Ecology Publication No. 
16-10-025, p. 56. https://fortress.wa.gov/ecy/publications/documents/1610025.pdf.
---------------------------------------------------------------------------

    These justifications are not risk management decisions. The first 
one ignores the fact that the other exposure pathways taken into 
account in a BAF--food consumed by aquatic organisms and sediment--are 
affected by water quality regulated under the CWA. The second 
justification disregards the fact that EPA's national default 
recommended BCFs from 1980 are no more reflective of Washington's 
waters than EPA's national default recommended BAFs from 2015. As for 
the third justification, accounting for more exposure pathways may 
increase the inputs in a BAF calculation, and therefore potentially 
increase uncertainty. But excluding known sources of chemical 
accumulation in aquatic organisms because additional inputs have the 
potential to introduce additional uncertainty is not scientifically 
supportable. The fourth justification mischaracterizes the use of BCFs. 
EPA used BCFs prior to 2000 but now only uses those BCFs when data to 
derive BAFs are unavailable or inconclusive. As noted above, while 
states have latitude to make risk management decisions in developing 
WQS, in doing so, that discretion does not go so far as to permit 
states to make decisions that are not consistent with EPA's regulations 
which require that criteria be based on sound scientific rationale (40 
CFR 131.11).
    3. PCB Cancer Risk Level (CRL): The State-adopted HHC for PCBs are 
not protective of Washington's designated uses because of the selected 
chemical-specific CRL, which is not based on a sound scientific 
rationale. Washington adopted HHC for PCBs of 0.00017 [micro]g/L for 
both ``water + organism'' and ``organism only'' based on a chemical-
specific CRL of 2.3 x 10<SUP>-</SUP>\5\. Washington's selected CRL of 
2.3 x 10<SUP>-</SUP>\5\ is akin to a cancer risk of approximately 1 in 
43,478, which is a greater risk than the 1 in 100,000 or 1 in 1,000,000 
CRLs which are commonly used by states and authorized tribes in their 
WQS. For all other pollutants except PCBs, Washington used a CRL of 1 
in 1,000,000 or 1 x 10<SUP>-</SUP>\6\. As explained below, Washington's 
criteria for PCBs do not protect designated uses and are not based on 
sound scientific rationale.
    First, Washington inappropriately links the stringency of its CRL 
with a value associated with its fish advisory program. In its 2016 
submittal, Washington explained that ``[t]he chemical-specific risk 
level for PCBs was chosen to be consistent with the level of risk/
hazard in the toxicity factor used by the [Washington Department of 
Health] in developing fish advisories.'' \58\ The toxicity value that 
the Washington Department of Health uses for fish advisories is an RfD 
for the non-cancer impacts of one particular mixture of PCBs. Fish 
advisory programs are not bound by the same statutory and regulatory 
obligations as WQS. Setting protective HHC for PCBs requires evaluating 
the carcinogenic effects of PCBs in addition to the non-cancer impacts, 
since PCBs are reasonably anticipated to be a human carcinogen.\59\ EPA 
has published a quantitative estimate of carcinogenic risk for 
PCBs.\60\ Relying on a risk level

[[Page 19054]]

associated solely with an RfD for non-cancer impacts used by the 
state's fish advisory program is thus not a sound scientific rationale 
for HHC that must protect against both carcinogenic and non-
carcinogenic adverse health effects. Additionally, fish advisories are 
intended to advise the public where current levels of pollution may 
result in designated uses not being met, whereas under EPA regulations, 
water quality criteria must be set at levels that ``protect'' the 
designated use (40 CFR 131.11(a)). Thus, criteria which are based in 
part on impaired water quality are not consistent with EPA's 
regulations.\61\
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    \58\ Department of Ecology. Washington State Water Quality: 
Human health criteria and implementation tools, Overview of key 
decisions in rule amendment. August 2016. Ecology Publication No. 
16-10-025, p. 67. https://fortress.wa.gov/ecy/publications/documents/1610025.pdf.
    \59\ U.S. Department of Health and Human Services (HHS). 
National Toxicology Program. 15th Report on Carcinogens. December 
21, 2021. https://ntp.niehs.nih.gov/whatwestudy/assessments/cancer/roc/index.html.
    \60\ https://iris.epa.gov/static/pdfs/0294_summary.pdf.
    \61\ While EPA has determined that fish advisories may be used 
in determining attainment of WQS, this is distinct from using such 
advisories in establishing WQS. See Letter from Geoffrey Grubbs, 
USEPA. 2000. (``EPA considers fish and shellfish tissue pollutant 
concentrations a scientifically defensible basis for determining 
attainment of water quality standards.'').
---------------------------------------------------------------------------

    Washington's choice of a less protective CRL for PCBs also cannot 
be reconciled with the particular characteristics of PCBs in the 
environment and the science underlying human exposure to PCBs. PCBs are 
a group of man-made compounds that are highly bioaccumulative in 
aquatic organisms and have high environmental persistence. Humans are 
exposed to PCBs through fish and shellfish consumption, and PCBs can 
accumulate in human tissue, causing adverse health effects. The primary 
source of exposure to PCBs is through high-fat foods \62\ such as 
higher trophic-level fish. Moreover, these higher trophic-level fish 
are a major component of a high fish consumers' diet in Washington. 
While there is no specific CRL mandated by EPA regulations, the 
selected CRL of 2.3 x 10<SUP>-</SUP>\5\ is over an order of magnitude 
greater than the CRL Washington uses for all other pollutants. Despite 
the particular risks present here, EPA has discerned no rationale 
related to health protection or risk management to support using a less 
protective pollutant specific CRL for this pollutant, which is of 
particular environmental concern, than is otherwise applicable for all 
other pollutants in the State (1 x 10<SUP>-</SUP>\6\ in Washington).
---------------------------------------------------------------------------

    \62\ https://www.atsdr.cdc.gov/csem/polychlorinated-biphenyls/what_routes.html.
---------------------------------------------------------------------------

    Finally, Washington's PCB criteria are based on an application of 
the HHC derivation equation that was outcome-determinative. Washington 
arrived at the PCB CRL by solving for what the CRL would be if the body 
weight and FCR inputs into the equation were updated and the desired 
end result was the NTR PCB criteria already in effect at the time. As 
noted above, Washington began with a CRL based on the level of risk/
hazard associated with that the State uses to develop fish advisories. 
When this CRL, paired with the updated body weight and FCR, resulted in 
criteria that were less stringent than the NTR PCB criteria, Washington 
then adjusted the CRL to maintain the NTR value.\63\
---------------------------------------------------------------------------

    \63\ Department of Ecology. Washington State Water Quality: 
Human health criteria and implementation tools, Overview of key 
decisions in rule amendment. August 2016. Ecology Publication No. 
16-10-025, p. 67. https://fortress.wa.gov/ecy/publications/documents/1610025.pdf.
---------------------------------------------------------------------------

    Thus, Washington's PCB criteria are the same as the PCB criteria in 
the NTR that EPA had determined in 2015 to be insufficient because they 
were based, in part, on a FCR of 6.5 g/day that EPA concluded was not 
representative of fish consumption in Washington, including consumption 
by tribes with reserved rights.\64\ While the State revised its FCR to 
175 g/day, its PCB-specific change to the CRL offset any additional 
health protection afforded by the FCR adjustment and therefore failed 
to remedy EPA's previous finding that the criteria did not adequately 
protect fish consumers in Washington. For the reasons above, EPA 
concludes that Washington's State-adopted HHC currently in effect for 
PCBs are not sufficient to protect Washington's designated uses and do 
not meet the requirements of the CWA.
---------------------------------------------------------------------------

    \64\ As described in EPA's 2016 final Washington WQS rule, 81 FR 
85422-26, numerous tribes in Washington have treaty-reserved rights 
to fish for their subsistence on waters throughout the State. EPA 
found that tribal members consume far greater quantities of fish in 
the exercise of those rights than the 6.5 g/day associated with the 
NTR PCB criteria, and accordingly found that those criteria were 
insufficiently protective. See 80 FR 55066.
---------------------------------------------------------------------------

B. Clean Water Act 303(c)(4)(B) Administrator's Determination

    Because the 2019 Reconsidered HHC, which are currently effective 
for CWA purposes in Washington, are not based on sound scientific 
rationale and are not protective of the applicable designated uses per 
the CWA and EPA's regulations at 40 CFR 131.11, EPA determines under 
CWA Section 303(c)(4)(B) that revised WQS for the protection of human 
health in Washington waters are necessary to meet the requirements of 
the CWA. EPA, therefore, proposes to revise these HHC for Washington in 
accordance with this CWA Section 303(c)(4)(B) Administrator's 
determination, as set forth in section V of this preamble. EPA's 
determination is not itself a final action, nor part of a final action, 
at this time. After consideration of comments on the proposed 
rulemaking, EPA will take final agency action on this proposed 
rulemaking. It is at that time that any change to the WQS applicable to 
Washington waters for CWA purposes would occur.

V. Derivation of Human Health Criteria for Washington

A. Scope of EPA's Proposal

    Based on the determination explained above, EPA is proposing 
Federal criteria that would supersede the 2019 Reconsidered HHC. EPA is 
not proposing to change or supersede the federal HHC that EPA 
promulgated for arsenic,\65\ 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.\66\
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    \65\ 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.
    \66\ EPA is not proposing to change or supersede Washington's 
HHC for dioxin and thallium that EPA approved in 2019. EPA had 
previously taken no action on these pollutants in 2016.
---------------------------------------------------------------------------

    The HHC in this proposed rulemaking would apply to surface waters 
under the State of Washington's jurisdiction, and not to waters within 
Indian country,\67\ unless otherwise specified in federal law.
---------------------------------------------------------------------------

    \67\ 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 proposes to derive 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 Washington used in 2016 \68\ and that EPA used in its 2016 federal 
rule.\69\ EPA does not have new data or information suggesting a need 
to revisit those choices at this time, and thus is applying the same 
rationale here as the agency articulated to support its use of those 
inputs in the 2016 federal rule.\70\ The agency believes 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-

[[Page 19055]]

methylethyl) ether), because these values are associated with the 
population that the criteria are intended to protect and are not 
pollutant-specific.
---------------------------------------------------------------------------

    \68\ 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.
    \69\ Revision of Certain Water Quality Standards Applicable to 
Washington, 81 FR 85417 (November 28, 2016).
    \70\ Id. at 85,420; 85,426-428.
---------------------------------------------------------------------------

b. Pollutant-Specific Reference Doses and Cancer Slope Factors
    EPA proposes to derive HHC for Washington using the same reference 
doses and cancer slope factors that Washington used in 2016 \71\ and 
that EPA used in its 2016 federal rule.\72\ These are the same toxicity 
values that EPA uses in its CWA Section 304(a) national 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 proposal.\73\ See 
Table 1, columns B1 and B3 for a list of EPA's proposed toxicity 
factors by pollutant.
---------------------------------------------------------------------------

    \71\ 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.
    \72\ Revision of Certain Water Quality Standards Applicable to 
Washington, 81 FR 85417 (November 28, 2016).
    \73\ 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.
---------------------------------------------------------------------------

c. Cancer Risk Level
    EPA proposes to derive HHC for Washington using the same CRL of 
10<SUP>-</SUP>\6\ that Washington used in 2016 \74\ and that EPA used 
in its 2016 federal rule \75\ for all pollutants, including PCBs.
---------------------------------------------------------------------------

    \74\ 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.
    \75\ Revision of Certain Water Quality Standards Applicable to 
Washington, 81 FR 85417 (November 28, 2016).
---------------------------------------------------------------------------

    EPA's selection of a 10<SUP>-</SUP>\6\ CRL is consistent with EPA's 
2000 Methodology, which states that EPA intends to use the 
10<SUP>-</SUP>\6\ level when promulgating water quality criteria for 
states and tribes, which reflects an appropriate risk for the general 
population.\76\ In addition, as noted above and in EPA's 2016 final 
rule for Washington,\77\ 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's selection of a 10<SUP>-</SUP>\6\ CRL is protective 
of tribal members exercising their legal right to harvest and consume 
fish and shellfish at subsistence levels.\78\
---------------------------------------------------------------------------

    \76\ EPA 2000 Methodology, p. 2-6. The Methodology recommends 
that states set human health criteria CRLs for the target general 
population at either 10<SUP>-</SUP>\5\ or 10<SUP>-</SUP>\6\ (p. 2-6) 
and also notes that states and authorized tribes can always choose a 
more stringent risk level, such as 10<SUP>-</SUP>\7\ (p. 1-12).
    \77\ 81 FR 85422-26.
    \78\ 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<SUP>-</SUP>\6\. 2016 Partial Approval/
Disapproval p. 15.
---------------------------------------------------------------------------

    Finally, 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 a FCR of 175 g/day 
and a CRL of 10<SUP>-</SUP>\6\. EPA's proposal to derive HHC for 
Washington using a CRL of 10<SUP>-</SUP>\6\ along with a 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).
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 III.B.d). In 2015, after evaluating information on chemical 
uses, properties, occurrences, releases to the environment and 
regulatory restrictions, EPA developed chemical-specific RSCs for non-
carcinogens and nonlinear carcinogens ranging from 0.2 (20 percent) to 
0.8 (80 percent) following the Exposure Decision Tree approach 
described in EPA's 2000 Human Health Methodology.<SUP>79 80</SUP>
---------------------------------------------------------------------------

    \79\ USEPA. 2000. Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health. U.S. Environmental 
Protection Agency, Office of Water, Washington, DC. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf.
    \80\ Final Updated Ambient Water Quality Criteria for the 
Protection of Human Health, (80 FR 36986, June 29, 2015). See also: 
USEPA. 2015. Final 2015 Updated National Recommended Human Health 
Criteria. U.S. Environmental Protection Agency, Office of Water, 
Washington, DC. https://www.epa.gov/wqc/human-health-water-quality-criteria.
---------------------------------------------------------------------------

    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. 
We then applied this ratio to the proportion of the RfD reserved for 
inland and nearshore fish consumption in the RSC. We 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) \81\ data (since CRITFC data were used to 
derive the 175 g/day FCR).
---------------------------------------------------------------------------

    \81\ 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 proposes to use these same 2016 RSCs 
to derive HHC for Washington in this rule, having no new data or 
information to suggest 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 for a list of 
EPA's proposed RSCs by pollutant.
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. As in the 2016 
federal rule for Washington,\82\

[[Page 19056]]

EPA proposes to apply the trophic level four BAF from the 2015 CWA 
Section 304(a) HHC updates in conjunction with the 175 g/day FCR.\83\ 
EPA has no new data or information to suggest an alternative to its 
2016 decision to use the trophic level four BAF, given that the species 
commonly consumed in Washington are trophic level four fish (e.g., 
salmon). Where science-based BAFs are not available at this time for 
certain pollutants, EPA proposes to use the BCFs that EPA used the last 
time it updated its CWA Section 304(a) recommended criteria for those 
pollutants as the best available scientific information. See Table 1, 
columns B4 and B5 for a list of EPA's proposed bioaccumulation factors 
by pollutant.
---------------------------------------------------------------------------

    \82\ Revision of Certain Water Quality Standards Applicable to 
Washington, 81 FR 85417 (November 28, 2016).
    \83\ 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 proposes to use 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).
---------------------------------------------------------------------------

C. Proposed Human Health Criteria for Washington

    EPA proposes 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). The proposed HHC 
are the same criteria that EPA promulgated in 2016. The water-plus-
organism criteria in column C1 of Table 1 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 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.
    EPA solicits comment on the criteria and the inputs EPA used to 
derive these criteria.

                                               Table 1--EPA Proposed Human Health Criteria for Washington
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      A                                                              B                                                     C
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Cancer slope     Relative      Reference                           Bio-          Water &
                                                factor, CSF      source       dose, RfD   Bio-accumulation    concentration    organisms  Organisms only
             Chemical                CAS No.     (per mg/    Contribution,      (mg/        factor (L/kg      factor  (L/kg   ([micro]g/    ([micro]g/L)
                                               kg[middot]d)     RSC (-)     kg[middot]d)       tissue)           tissue)          L)
                                    .........          (B1)          (B2)           (B3)              (B4)              (B5)        (C1)            (C2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. 1,1,1-Trichloroethane..........      71556  ............          0.50              2                10  ................      20,000          50,000
2. 1,1,2,2-Tetrachloroethane......      79345           0.2  .............  ............               8.4  ................         0.1             0.3
3. 1,1,2-Trichloroethane..........      79005         0.057  .............  ............               8.9  ................        0.35            0.90
4. 1,1-Dichloroethylene...........      75354  ............          0.50           0.05               2.6  ................         700           4,000
5. 1,2,4-Trichlorobenzene.........     120821         0.029  .............  ............               430  ................       0.036           0.037
6. 1,2-Dichlorobenzene............      95501  ............          0.50            0.3                82  ................         700             800
7. 1,2-Dichloroethane.............     107062        0.0033  .............  ............               1.9  ................         8.9              73
8. 1,2-Diphenylhydrazine..........     122667           0.8  .............  ............                27  ................        0.01            0.02
9. 1,2-Trans-Dichloroethylene.....     156605  ............          0.50           0.02               4.7  ................         200           1,000
10. 1,3-Dichlorobenzene...........     541731  ............          0.50          0.002               190  ................           2               2
11. 1,3-Dichloropropene...........     542756         0.122  .............  ............               3.0  ................        0.22             1.2
12. 1,4-Dichlorobenzene...........     106467  ............          0.50           0.07                84  ................         200             200
13. 2,4-Dichlorophenol............     120832  ............          0.50          0.003                48  ................          10              10
14. 2,4-Dinitrophenol.............      51285  ............          0.50          0.002               4.4  ................          30             100
15. 2-Chloronaphthalene...........      91587  ............          0.80           0.08               240  ................         100             100
16. 2-Methyl-4,6-Dinitrophenol....     534521  ............          0.50         0.0003                10  ................           3               7
17. 4,4'-DDD......................      72548          0.24  .............  ............           240,000  ................    7.9E-06.         7.9E-06
18. 4,4'-DDE......................      72559         0.167  .............  ............         3,100,000  ................     8.8E-07         8.8E-07
19. 4,4'-DDT......................      50293          0.34  .............  ............         1,100,000  ................     1.2E-06         1.2E-06
20. Acenaphthene..................      83329  ............          0.50           0.06               510  ................          30              30
21. Aldrin........................     309002            17  .............  ............           650,000  ................     4.1E-08         4.1E-08
22. alpha-BHC.....................     319846           6.3  .............  ............             1,500  ................     4.8E-05         4.8E-05
23. alpha-Endosulfan..............     959988  ............          0.50          0.006               200  ................           6               7
24. Anthracene....................     120127  ............          0.50            0.3               610  ................         100             100
25. Antimony......................    7440360  ............          0.50         0.0004  ................                 1           6              90
26. Benzo(a) Anthracene...........      56553          0.73  .............  ............             3,900  ................     0.00016         0.00016
27. Benzo(a) Pyrene...............      50328           7.3  .............  ............             3,900  ................     1.6E-05         1.6E-05
28. Benzo(b) Fluoranthene.........     205992          0.73  .............  ............             3,900  ................     0.00016         0.00016
29. Benzo(k) Fluoranthene.........     207089         0.073  .............  ............             3,900  ................      0.0016          0.0016
30. beta-BHC......................     319857           1.8  .............  ............               180  ................      0.0013          0.0014
31. Bis(2-Ethylhexyl) Phthalate...     117817         0.014  .............  ............               710  ................       0.045           0.046
32. Bromoform.....................      75252        0.0045  .............  ............               8.5  ................         4.6              12
33. Butylbenzyl Phthalate.........      85687        0.0019  .............  ............            19,000  ................       0.013           0.013
34. Chlordane.....................      57749          0.35  .............  ............            60,000  ................     2.2E-05         2.2E-05
35. Chlorobenzene.................     108907  ............          0.50           0.02                22  ................         100             200
36. Chlorodibromomethane..........     124481          0.04  .............  ............               5.3  ................        0.60             2.2
37. Chloroform....................      67663  ............          0.50           0.01               3.8  ................         100             600
38. Chrysene......................     218019        0.0073  .............  ............             3,900  ................       0.016           0.016
39. Cyanide.......................      57125  ............          0.50         0.0006  ................                 1           9             100
40. Dibenzo(a,h) Anthracene.......      53703           7.3  .............  ............             3,900  ................    1.6E-05.         1.6E-05
41. Dichlorobromomethane..........      75274         0.034  .............  ............               4.8  ................        0.73             2.8
42. Dieldrin......................      60571            16  .............  ............           410,000  ................     7.0E-08         7.0E-08
43. Diethyl Phthalate.............      84662  ............          0.50            0.8               920  ................         200             200
44. Dimethyl Phthalate............     131113  ............          0.50             10             4,000  ................         600             600

[[Page 19057]]

 
45. Di-n-Butyl Phthalate..........      84742  ............          0.50            0.1             2,900  ................           8               8
46. Endosulfan Sulfate............    1031078  ............          0.50          0.006               140  ................           9  ..............
47. Endrin........................      72208  ............          0.80         0.0003            46,000  ................       0.002           0.002
48. Ethylbenzene..................     100414  ............          0.50          0.022               160  ................          29              31
49. Fluoranthene..................     206440  ............          0.50           0.04             1,500  ................           6               6
50. Fluorene......................      86737  ............          0.50           0.04               710  ................          10              10
51. gamma-BHC; Lindane............      58899  ............          0.50         0.0047             2,500  ................        0.43            0.43
52. Heptachlor....................      76448           4.1  .............  ............           330,000  ................     3.4E-07         3.4E-07
53. Heptachlor Epoxide............    1024573           5.5  .............  ............            35,000  ................     2.4E-06         2.4E-06
54. Hexachlorobenzene.............     118741          1.02  .............  ............            90,000  ................     5.0E-06         5.0E-06
55. Hexachlorobutadiene...........      87683          0.04  .............  ............             1,100  ................        0.01            0.01
56. Hexachlorocyclopentadiene.....      77474  ............          0.50          0.006             1,300  ................           1               1
57. Hexachloroethane..............      67721          0.04  .............  ............               600  ................        0.02            0.02
58. Indeno(1,2,3-cd) Pyrene.......     193395          0.73  .............  ............             3,900  ................     0.00016         0.00016
59. Methyl Bromide................      74839  ............          0.50           0.02               1.4  ................         300  ..............
60. Methylene Chloride............      75092         0.002  .............  ............               1.6  ................          10             100
61. Nickel........................    7440020  ............          0.50           0.02  ................                47          80             100
62. Nitrobenzene..................      98953  ............          0.50          0.002               3.1  ................          30             100
63. Pentachlorophenol (PCP).......      87865           0.4  .............  ............               520  ................       0.002           0.002
64. Phenol........................     108952  ............          0.50            0.6               1.9  ................       9,000          70,000
65. Polychlorinated Biphenyls       .........             2  .............  ............  ................            31,200    \a\7E-06        \a\7E-06
 (PCBs)...........................
66. Pyrene........................     129000  ............          0.50           0.03               860  ................           8               8
67. Selenium......................    7782492  ............          0.50          0.005  ................               4.8          60             200
68. Tetrachloroethylene...........     127184        0.0021  .............  ............                76  ................         2.4             2.9
69. Toluene.......................     108883  ............          0.50         0.0097                17  ................          72             130
79. Trichloroethylene.............      79016          0.05  .............  ............                13  ................         0.3             0.7
71. Vinyl Chloride................      75014           1.5  .............  ............               1.7  ................  ..........            0.18
72. Zinc..........................    7440666  ............          0.50            0.3  ................                47       1,000           1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ This criterion applies to total PCBs (e.g., the sum of all congener or isomer or homolog or Aroclor analyses).

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 proposing revised HHC for Washington, 
Washington continues to have the option to adopt and submit to EPA 
revised HHC for the State's waters consistent with CWA Section 303(c) 
and EPA's implementing regulations at 40 CFR part 131. Consistent with 
CWA Section 303(c)(4), if Washington adopts and submits revised HHC and 
EPA approves such criteria before finalizing this proposed rulemaking, 
EPA would not proceed with the final rule for those waters and/or 
pollutants for which EPA approves Washington's criteria.
    If EPA finalizes this proposed rulemaking, and Washington 
subsequently adopts and submits new HHC, EPA's federally promulgated 
criteria will remain applicable for purposes of the CWA until EPA 
withdraws the federally promulgated criteria. EPA would undertake such 
a rulemaking to withdraw the Federal criteria if and when Washington 
adopts and EPA approves corresponding criteria that meet the 
requirements of Section 303(c) of the CWA and EPA's implementing 
regulations at 40 CFR part 131.

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, once finalized. 
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 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 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 proposed 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 in 
the regulation. If Washington removes a use and adopts the highest 
attainable use,\84\ the State must also

[[Page 19058]]

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 finds 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).
---------------------------------------------------------------------------

    \84\ 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)).
---------------------------------------------------------------------------

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 
proposing 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.\85\ EPA 
already 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.
---------------------------------------------------------------------------

    \85\ 80 FR 51022, August 21, 2015.
---------------------------------------------------------------------------

VI. 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 proposed WQS. Costs might also arise to holders of 
general permits \86\ should the State modify those permits in some 
manner as a result of the proposed WQS, once finalized. Costs might 
also arise to sectors whose operations are nonpoint sources of 
pollutants through implementation of TMDLs or through other voluntary, 
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.
---------------------------------------------------------------------------

    \86\ General permits typically focus on best management 
practices.
---------------------------------------------------------------------------

    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 proposed criteria. This analysis is documented 
in ``Economic Analysis for Water Quality Standards Applicable to the 
State of Washington,'' which can be found in the record for this 
rulemaking. 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

[[Page 19059]]

affected by this proposed rulemaking. 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 to Point Sources

    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 proposed 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 proposed rulemaking.
    EPA assumes that dischargers would pursue the least cost means of 
compliance with WQBELs. Compliance actions attributable to the proposed 
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,\87\ EPA did not identify any incremental 
costs to any major point source discharges of process wastewater from 
POTWs or industrial facilities attributable to the proposed 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 did 
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.
---------------------------------------------------------------------------

    \87\ 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.
---------------------------------------------------------------------------

    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 proposed rulemaking have analytical quantitation 
limits that are above both the criteria currently in place and the 
proposed criteria. PCBs are a good example. The current criterion in 
place is 170 picograms per liter (pg/L) and the proposed criterion is 7 
pg/L. However, the State identifies the analytical quantitation limit 
for effluent measurement as 500,000 pg/L. 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 pg/L, which is a substantial improvement over 
the current regulatory method, but still well above either the 
criterion currently in place or the proposed 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 the proposed 
criteria. Using available ambient monitoring data, EPA compared 
pollutant concentrations to the baseline and proposed criteria, 
identifying waterbodies that may be incrementally impaired (i.e., 
impaired under the proposed criteria but not under the baseline). EPA 
identified 36 impairments under the baseline criteria and 66 under the 
proposed criteria, resulting in 30 potential incremental impairments. 
The estimated total annual costs for TMDL development range from 
$98,000 to $179,000, 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.

VII. Statutory and Executive Order Reviews

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

    It has been determined that this proposed rulemaking is not a 
``significant regulatory action'' under the terms of Executive Order 
12866 (58 FR 51735, October 4, 1993) and is, therefore, not subject to 
review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 
2011).

[[Page 19060]]

B. Paperwork Reduction Act

    This action does not impose any new information collection burden 
under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et 
seq. OMB has previously approved the information collection activities 
contained in the existing regulations at 40 CFR part 131 and has 
assigned OMB control number 2040-0049.

C. Regulatory Flexibility Act

    I certify that this proposed rulemaking will not have a significant 
economic impact on a substantial number of small entities under the 
Regulatory Flexibility Act (RFA). Small entities, such as small 
businesses or small governmental jurisdictions, are not directly 
regulated by this rule. This proposed rulemaking will not impose any 
requirements on small entities.

D. Unfunded Mandates Reform Act

    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

    This action does not have federalism implications. It will not have 
substantial direct effects on the states, on the relationship between 
the national government and the states, or on the distribution of power 
and responsibilities among the various levels of government. This rule 
does not alter Washington's considerable discretion in implementing 
these WQS, nor would it preclude Washington from adopting WQS that EPA 
concludes meet the requirements of the CWA, either before or after 
promulgation of the final rule, which would eliminate the need for 
federal standards. Thus, Executive Order 13132 does not apply to this 
action.
    In the spirit of Executive Order 13132 and consistent with EPA 
policy to promote communications between EPA and state and local 
governments, EPA specifically solicits comments on this proposed action 
from state and local officials.

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, and because the proposed 
Washington criteria are informed by tribal reserved rights. 
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 officials under the EPA Policy on 
Consultation and Coordination with Indian Tribes early in the process 
of developing this regulation to permit them to have meaningful and 
timely input into its development. In August 2021, EPA held tribes-only 
technical staff and leadership consultation sessions to hear their 
views and answer questions of all interested tribes on the proposed 
rulemaking. Representatives from approximately 17 tribes and two tribal 
consortia participated in two leadership meetings held in August 2021. 
The tribes have repeatedly asked EPA to reinstate the 2016 federal HHC 
for Washington, which EPA is proposing to do in this rule. EPA 
considered the input received during consultation with tribes when 
developing this proposal.
    A Summary of EPA's Pre-Proposal Consultation, Coordination, and 
Outreach With Federally Recognized Tribes on Potential Restoration of 
Protective Human Heath Criteria for Washington is available in the 
docket for this proposal.

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

    This proposed rulemaking is not subject to Executive Order 13045 
because it is not economically significant as defined in Executive 
Order 12866, and because EPA does not believe the environmental health 
or safety risks addressed by this action present a disproportionate 
risk to children. As noted in section III.A of this preamble, 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 proposed 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.

I. National Technology Transfer and Advancement Act of 1995

    This proposed rulemaking does not involve technical standards.

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

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.\88\ Three Executive Orders (E.O. 12898,\89\ 13985 \90\ and 
14008 \91\) advance EJ by calling on federal agencies to identify and 
address disproportionate

[[Page 19061]]

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).\92\
---------------------------------------------------------------------------

    \88\ 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, www.epa.gov/environmentaljustice/guidanceconsidering-environmental-justice-duringdevelopment-action. See also https://www.epa.gov/environmentaljustice.
    \89\ Federal Actions to Address Environmental Justice in 
Minority Populations and Low-Income Populations. Available at 
https://www.epa.gov/environmentaljustice/federal-actions-address-environmental-justice-minority-populations-and-low, accessed October 
6, 2021.
    \90\ Advancing Racial Equity and Support for Underserved 
Communities Through the Federal Government. Available at https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government, accessed October 6, 2021.
    \91\ Tackling the Climate Crisis at Home and Abroad. Available 
at https://www.federalregister.gov/documents/2021/02/01/2021-02177/tackling-the-climate-crisis-at-home-and-abroad. Accessed October 6, 
2021.
    \92\ 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.'').
---------------------------------------------------------------------------

    EPA believes that this proposed rulemaking, if finalized, 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 VI 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 proposing to restore 
HHC in Washington that account for 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.\93\ 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 from water into 
fish and expose fish consumers to a greater risk of cancer from PCB 
exposure.
---------------------------------------------------------------------------

    \93\ 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. https://apps.ecology.wa.gov/publications/documents/1209058.pdf.
---------------------------------------------------------------------------

    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 reserved rights off 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.\94\ Specifically, this rule proposes to establish HHC based 
on a FCR of 175 g/day reflective of regional tribal FCR survey data 
\95\ to represent and protect higher fish consumers. Because a FCR of 
175 g/day is a compromise rate in the absence of conclusive data 
regarding unsuppressed fish consumption levels, the rule proposes to 
use a CRL of 10<SUP>-</SUP>\6\ to derive HHC for all cancer-causing 
pollutants, including PCBs, to ensure that the effective CRL for tribes 
exercising treaty rights to fish is no greater than 10<SUP>-</SUP>\5\.
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    \94\ 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.'').
    \95\ 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 proposed rulemaking considers the interests and 
perspective of tribes, we engaged with tribes that may be affected by 
this action to receive meaningful and timely input from tribal 
officials as we developed the proposal. See section VII.F 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 
rulemaking under the CWA.

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 proposes to amend 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 paragraph (b).

[[Page 19062]]



                                             Table 1 to Paragraph (b)--Human Health Criteria for Washington
--------------------------------------------------------------------------------------------------------------------------------------------------------
                     A                                                              B                                                      C
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                             Cancer slope                     Reference                           Bio-          Water &
                                              factor, CSF  Relative source    dose, RfD   Bio-accumulation    concentration    organisms  Organisms only
            Chemical               CAS No.     (per mg/     contribution,       (mg/        factor (L/kg      factor  (L/kg   ([micro]g/    ([micro]g/L)
                                             kg[middot]d)      RSC (-)      kg[middot]d)       tissue)           tissue)          L)
                                  .........          (B1)             (B2)          (B3)              (B4)              (B5)        (C1)            (C2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. 1,1,1-Trichloroethane........      71556  ............             0.50             2                10  ................      20,000          50,000
2. 1,1,2,2-Tetrachloroethane....      79345           0.2  ...............  ............               8.4  ................         0.1             0.3
3. 1,1,2-Trichloroethane........      79005         0.057  ...............  ............               8.9  ................        0.35            0.90
4. 1,1-Dichloroethylene.........      75354  ............             0.50          0.05               2.6  ................         700           4,000
5. 1,2,4-Trichlorobenzene.......     120821         0.029  ...............  ............               430  ................       0.036           0.037
6. 1,2-Dichlorobenzene..........      95501  ............             0.50           0.3                82  ................         700             800
7. 1,2-Dichloroethane...........     107062        0.0033  ...............  ............               1.9  ................         8.9              73
8. 1,2-Diphenylhydrazine........     122667           0.8  ...............  ............                27  ................        0.01            0.02
9. 1,2-Trans-Dichloroethylene...     156605  ............             0.50          0.02               4.7  ................         200           1,000
10. 1,3-Dichlorobenzene.........     541731  ............             0.50         0.002               190  ................           2               2
11. 1,3-Dichloropropene.........     542756         0.122  ...............  ............               3.0  ................        0.22             1.2
12. 1,4-Dichlorobenzene.........     106467  ............             0.50          0.07                84  ................         200             200
13. 2,4-Dichlorophenol..........     120832  ............             0.50         0.003                48  ................          10              10
14. 2,4-Dinitrophenol...........      51285  ............             0.50         0.002               4.4  ................          30             100
15. 2-Chloronaphthalene.........      91587  ............             0.80          0.08               240  ................         100             100
16. 2-Methyl-4,6-Dinitrophenol..     534521  ............             0.50        0.0003                10  ................           3               7
17. 4,4'-DDD....................      72548          0.24  ...............  ............           240,000  ................     7.9E-06         7.9E-06
18. 4,4'-DDE....................      72559         0.167  ...............  ............         3,100,000  ................     8.8E-07         8.8E-07
19. 4,4'-DDT....................      50293          0.34  ...............  ............         1,100,000  ................     1.2E-06         1.2E-06
20. Acenaphthene................      83329  ............             0.50          0.06               510  ................          30              30
21. Aldrin......................     309002            17  ...............  ............           650,000  ................     4.1E-08         4.1E-08
22. alpha-BHC...................     319846           6.3  ...............  ............             1,500  ................     4.8E-05         4.8E-05
23. alpha-Endosulfan............     959988  ............             0.50         0.006               200  ................           6               7
24. Anthracene..................     120127  ............             0.50           0.3               610  ................         100             100
25. Antimony....................    7440360  ............             0.50        0.0004  ................                 1           6              90
26. Arsenic *...................    7440382          1.75  ...............  ............  ................                44   \a\ 0.018        \a\ 0.14
27. Benzo(a) Anthracene.........      56553          0.73  ...............  ............             3,900  ................     0.00016         0.00016
28. Benzo(a) Pyrene.............      50328           7.3  ...............  ............             3,900  ................     1.6E-05         1.6E-05
29. Benzo(b) Fluoranthene.......     205992          0.73  ...............  ............             3,900  ................     0.00016         0.00016
30. Benzo(k) Fluoranthene.......     207089         0.073  ...............  ............             3,900  ................      0.0016          0.0016
31. beta-BHC....................     319857           1.8  ...............  ............               180  ................      0.0013          0.0014
32. Bis(2-Chloro-1-Methylethyl)      108601  ............             0.50          0.04                10  ................         400             900
 Ether **.......................
33. Bis(2-Ethylhexyl) Phthalate.     117817         0.014  ...............  ............               710  ................       0.045           0.046
34. Bromoform...................      75252        0.0045  ...............  ............               8.5  ................         4.6              12
35. Butylbenzyl Phthalate.......      85687        0.0019  ...............  ............            19,000  ................       0.013           0.013
36. Chlordane...................      57749          0.35  ...............  ............            60,000  ................     2.2E-05         2.2E-05
37. Chlorobenzene...............     108907  ............             0.50          0.02                22  ................         100             200
38. Chlorodibromomethane........     124481          0.04  ...............  ............               5.3  ................        0.60             2.2
39. Chloroform..................      67663  ............             0.50          0.01               3.8  ................         100             600
40. Chrysene....................     218019        0.0073  ...............  ............             3,900  ................       0.016           0.016
41. Cyanide.....................      57125  ............             0.50        0.0006  ................                 1           9             100
42. Dibenzo(a,h) Anthracene.....      53703           7.3  ...............  ............             3,900  ................     1.6E-05         1.6E-05
43. Dichlorobromomethane........      75274         0.034  ...............  ............               4.8  ................        0.73             2.8
44. Dieldrin....................      60571            16  ...............  ............           410,000  ................     7.0E-08         7.0E-08
45. Diethyl Phthalate...........      84662  ............             0.50           0.8               920  ................         200             200
46. Dimethyl Phthalate..........     131113  ............             0.50            10             4,000  ................         600             600
47. Di-n-Butyl Phthalate........      84742  ............             0.50           0.1             2,900  ................           8               8
48. Endosulfan Sulfate..........    1031078  ............             0.50         0.006               140  ................           9  ..............
49. Endrin......................      72208  ............             0.80        0.0003            46,000  ................       0.002           0.002
50. Ethylbenzene................     100414  ............             0.50         0.022               160  ................          29              31
51. Fluoranthene................     206440  ............             0.50          0.04             1,500  ................           6               6
52. Fluorene....................      86737  ............             0.50          0.04               710  ................          10              10
53. gamma-BHC; Lindane..........      58899  ............             0.50        0.0047             2,500  ................        0.43            0.43
54. Heptachlor..................      76448           4.1  ...............  ............           330,000  ................     3.4E-07         3.4E-07
55. Heptachlor Epoxide..........    1024573           5.5  ...............  ............            35,000  ................     2.4E-06         2.4E-06
56. Hexachlorobenzene...........     118741          1.02  ...............  ............            90,000  ................     5.0E-06         5.0E-06
57. Hexachlorobutadiene.........      87683          0.04  ...............  ............             1,100  ................        0.01            0.01
58. Hexachlorocyclopentadiene...      77474  ............             0.50         0.006             1,300  ................           1               1
59. Hexachloroethane............      67721          0.04  ...............  ............               600  ................        0.02            0.02
60. Indeno(1,2,3-cd) Pyrene.....     193395          0.73  ...............  ............             3,900  ................     0.00016         0.00016
61. Methyl Bromide..............      74839  ............             0.50          0.02               1.4  ................         300  ..............
62. Methylene Chloride..........      75092         0.002  ...............  ............               1.6  ................          10             100
63. Methylmercury...............   22967926  ............          2.7E-05        0.0001  ................  ................  ..........   \b\ 0.03 (mg/
                                                                                                                                                     kg)
64. Nickel......................    7440020  ............             0.50          0.02  ................                47          80             100
65. Nitrobenzene................      98953  ............             0.50         0.002               3.1  ................          30             100
66. Pentachlorophenol (PCP).....      87865           0.4  ...............  ............               520  ................       0.002           0.002
67. Phenol......................     108952  ............             0.50           0.6               1.9  ................       9,000          70,000
68. Polychlorinated Biphenyls     .........             2  ...............  ............  ................            31,200   \c\ 7E-06       \c\ 7E-06
 (PCBs).........................
69. Pyrene......................     129000  ............             0.50          0.03               860  ................           8               8
70. Selenium....................    7782492  ............             0.50         0.005  ................               4.8          60             200
71. Tetrachloroethylene.........     127184        0.0021  ...............  ............                76  ................         2.4             2.9
72. Toluene.....................     108883  ............             0.50        0.0097                17  ................          72             130

[[Page 19063]]

 
73. Trichloroethylene...........      79016          0.05  ...............  ............                13  ................         0.3             0.7
74. Vinyl Chloride..............      75014           1.5  ...............  ............               1.7  ................  ..........            0.18
75. Zinc........................    7440666  ............             0.50           0.3  ................                47       1,000           1,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ This criterion refers to the inorganic form of arsenic only.
\b\ This criterion is expressed as the fish tissue concentration of methylmercury (mg methylmercury/kg fish). See Water Quality Criterion for the
  Protection of Human Health: Methylmercury (EPA-823-R-01-001, January 3, 2001) for how this value is calculated using the criterion equation in EPA's
  2000 Human Health Methodology rearranged to solve for a protective concentration in fish tissue rather than in water.
\c\ This criterion applies to total PCBs (e.g., the sum of all congener or isomer or homolog or Aroclor analyses).
* These criteria were promulgated for Washington in the National Toxics Rule at 40 CFR 131.36, and are moved into 40 CFR 131.45 to have one
  comprehensive human health criteria rule for Washington.
** Bis(2-Chloro-1-Methylethyl) Ether was previously listed as Bis(2-Chloroisopropyl) Ether.

* * * * *
[FR Doc. 2022-06879 Filed 3-31-22; 8:45 am]
BILLING CODE 6560-50-P


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