
[Federal Register Volume 88, Number 235 (Friday, December 8, 2023)]
[Proposed Rules]
[Pages 85530-85553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26734]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[EPA-HQ-OW-2023-0378; FRL-10761-01-OW]
RIN 2040-AG31


Water Quality Standards To Protect Human Health in Florida

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) proposes to 
establish new and revised human health water quality criteria for 
certain pollutants in the state of Florida. On December 1, 2022, the 
EPA issued an Administrator's Determination that Florida's existing 
human health criteria (HHC) are not protective of Florida's designated 
uses and that additional HHC are needed for certain priority toxic 
pollutants for which Florida currently lacks any HHC. Accordingly, the 
EPA is proposing new and revised HHC to protect the human health 
designated uses of Florida's waters.

DATES: Comments must be received on or before February 6, 2024. Public 
Hearing: The 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-2023-0378, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/ 
(our preferred method). Follow the online instructions for submitting 
comments.
     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.
     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. to 4:30 p.m., Monday through Friday (except 
Federal holidays).
    Instructions: All submissions received must include the Docket ID 
No. EPA-HQ-OW-2023-0378 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. The 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 Weyer, Office of Water, 
Standards and Health Protection Division (4305T), Environmental 
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; 
telephone number: (202) 566-2793; email address: [email protected]. 
Additional information is also available online at https://www.epa.gov/wqs-tech/water-quality-standards-protect-human-health-florida.

SUPPLEMENTARY INFORMATION: This proposed rulemaking is organized as 
follows:

I. Public Participation
    A. Written Comments
    B. Participation in 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. History of Florida's Human Health Criteria
IV. Derivation of Human Health Criteria for Florida
    A. Scope of EPA's Proposal
    B. Tribal Reserved Rights Applicable to Florida's Waters
    C. Human Health Criteria Inputs
    D. Proposed Human Health Criteria for Florida
    E. Applicability
    F. Alternative Regulatory Approaches and Implementation 
Mechanisms
V. Economic Analysis
    A. Identifying Affected Entities
    B. Method for Estimating Costs
    C. Results
VI. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and 
Executive Order 14094: Modernizing Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From 
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act of 1995
    J. Executive Order 12898: Federal Actions To Address 
Environmental Justice in Minority Populations and Low-Income 
Populations and Executive Order 14096: Revitalizing our Nation's 
Commitment to Environmental Justice for All

I. Public Participation

A. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2023-
0378, 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. The EPA may 
publish any comment received to its public docket. Do not submit to the 
EPA's docket at https://www.regulations.gov any information you 
consider to be Confidential Business Information (CBI), Proprietary 
Business Information (PBI) 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. The EPA will generally not consider comments or comment

[[Page 85531]]

contents located outside of the primary submission (i.e., on the web, 
cloud, or other file sharing system). Please visit https://www.epa.gov/dockets/commenting-epa-dockets for additional submission methods; the 
full EPA public comment policy; information about CBI, PBI, or 
multimedia submissions; and general guidance on making effective 
comments.

B. Participation in Public Hearings

    The EPA is offering two online public hearings so that interested 
parties may 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/water-quality-standards-protect-human-health-florida. If, due to unforeseen 
circumstances, either of these public hearings are canceled or 
rescheduled, the EPA will provide an update on this website.

II. General Information

A. Does this action apply to me?

    Entities that discharge pollutants to surface waters under the 
state of Florida's jurisdiction--such as industrial facilities and 
municipalities that manage stormwater or separate sanitary sewer 
systems--could be indirectly 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 Florida for 
CWA purposes. Categories and entities that could potentially be 
affected by this rulemaking include the following:

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                                             Examples of potentially
                Category                        affected entities
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Industry...............................  Industrial point sources
                                          discharging pollutants to
                                          waters in Florida.
Municipalities, including those with     Publicly owned treatment works
 stormwater or separate sanitary sewer    or similar facilities
 system outfalls.                         responsible for managing
                                          stormwater or separate
                                          sanitary sewer systems that
                                          discharge pollutants to waters
                                          in Florida.
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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 a national goal of ``water 
quality which provides for the protection and propagation of fish, 
shellfish, and wildlife and provides for recreation in and on the 
water,'' wherever attainable. See also 40 CFR 131.2. The EPA interprets 
``fishable'' to mean that, at a minimum, the designated uses promote 
the protection of fish and shellfish communities and that, when caught, 
these can be safely consumed by humans.\1\
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    \1\ USEPA. (2000, October 24). Memorandum from Geoffrey Grubbs 
and Robert Wayland, #WQSP-00-03. https://www.epa.gov/sites/default/files/2015-01/documents/standards-shellfish.pdf.
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    Under the CWA, states have the primary responsibility for 
reviewing, establishing, and revising WQS applicable to their waters 
(CWA section 303(c)). WQS define the desired condition of a water body, 
in part, by designating the use or uses to be made of the water (40 CFR 
131.2 and 131.10) and by setting the numeric or narrative water quality 
criteria to protect those uses (40 CFR 131.2 and 131.11). There are two 
primary categories of water quality criteria: human health criteria 
(HHC) and aquatic life criteria. HHC protect designated uses such as 
public water supply, recreation, and fish and shellfish consumption. 
Aquatic life criteria protect designated uses such as survival, growth, 
and reproduction of fish, invertebrates, and other aquatic species. 
Water quality criteria ``must be based on sound scientific rationale 
and must contain sufficient parameters or constituents to protect the 
designated use. For waters with multiple use designations, the criteria 
shall support the most sensitive use'' (40 CFR 131.11(a)(1)).
    Section 304(a) of the CWA directs the EPA to periodically develop 
and publish recommended water quality criteria ``accurately reflecting 
the latest scientific knowledge'' on the effects of pollutants on human 
health and welfare, including effects on aquatic life, as well as 
information on those pollutants, including their concentration and 
dispersal and how pollutants affect receiving waters (CWA section 
304(a)(1)). Those recommendations are available to states for use in 
developing their own water quality criteria (CWA section 304(a)(3)). In 
2015, the EPA updated its CWA section 304(a) national recommended 
criteria for human health for 94 pollutants.\2\ When states establish 
criteria, the EPA's regulation at 40 CFR 131.11(b)(1) specifies that 
they should establish numeric criteria based on: (1) the EPA's CWA 
section 304(a) recommended criteria, (2) modified 304(a) recommended 
criteria that reflect site-specific conditions or (3) other 
scientifically defensible methods.
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    \2\ USEPA. 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. https://www.epa.gov/wqc/national-recommended-water-quality-criteria-human-health-criteria-table.
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    CWA section 303(c)(2)(B), added to the CWA in the 1987 amendments 
to the Act,\3\ requires states to adopt numeric criteria, where 
available, for all toxic pollutants listed pursuant to CWA section 
307(a)(1) (i.e., priority toxic pollutants \4\) for which the EPA has 
published CWA section 304(a) recommended criteria, the discharge or 
presence of which could reasonably be expected to interfere with the 
states' designated uses. As articulated in the EPA's December 12, 1988, 
Guidance for State Implementation of Water Quality Standards for CWA 
Section 303(c)(2)(B) (`1988 Guidance'), the EPA identified three 
options that states could use to meet the requirements of CWA section 
303(c)(2)(B).\5\ Option 1 is to adopt statewide numeric water quality 
criteria for all priority toxic pollutants for which the EPA has issued 
CWA section 304(a) recommendations, regardless of whether those 
pollutants are known to be present in a state's waters.\6\ Option 2 is 
to adopt chemical-specific numeric water quality criteria for those 
priority toxic pollutants for which the EPA has issued CWA section 
304(a) recommendations, and ``where the State determines based on 
available information that the pollutants are present or discharged and 
can reasonably be expected to interfere with

[[Page 85532]]

designated uses.'' \7\ Option 3 is to adopt a procedure to be applied 
to a narrative water quality standard to be used in calculating derived 
numeric criteria.\8\ In the 1992 National Toxics Rule, the EPA 
promulgated water quality criteria for priority toxic pollutants for 14 
states based on the Administrator's Determination that new or revised 
criteria were needed to bring those states into compliance with the 
requirements of CWA section 303(c)(2)(B).\9\
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    \3\ Water Quality Act Amendments of 1987, Public Law 100-4, 101 
Stat. 7.
    \4\ See 40 CFR part 423, Appendix A--126 Priority Pollutants.
    \5\ USEPA. (December 1988). Transmittal of Final ``Guidance for 
State Implementation for Water Quality Standards under CWA Section 
303(c)(2)(B),'' https://www.epa.gov/sites/production/files/2014-10/documents/cwa303c-hanmer-memo.pdf; see also USEPA. (1992, December 
22). Establishment of Numeric Criteria for Priority Toxic 
Pollutants, 57 FR 60848, 60853.
    \6\ Id.
    \7\ Id.
    \8\ Id.
    \9\ Id. at 60857.
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    States are required to hold a public hearing to review applicable 
WQS at least once every three years and, if appropriate, revise or 
adopt new standards (CWA section 303(c)(1); 40 CFR 131.20(a)). This 
includes adopting criteria for additional priority toxic pollutants and 
revising existing priority toxic pollutant criteria as appropriate 
based on new information.\10\ Any new or revised WQS must be submitted 
to the EPA for review and approval or disapproval (CWA section 
303(c)(2)(A) and (c)(3)). CWA section 303(c)(4)(B) independently 
authorizes the Administrator to determine that a new or revised 
standard is necessary to meet CWA requirements.
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    \10\ Id. at 60873 (Explaining that ``EPA expects to request 
States to continue to focus on adopting criteria for additional 
toxic pollutants and revising existing criteria in future triennial 
reviews which new information indicates is appropriate.'').
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    Finally, in exercising its CWA section 303(c) authority, the EPA 
has an obligation to ensure that its actions are consistent with 
treaties, statutes, and executive orders reflecting Tribal reserved 
rights. Tribal reserved rights to aquatic resources could be impaired 
by water quality levels that limit right holders' ability to utilize 
their rights.

B. General Recommended Approach for Deriving Human Health Criteria

    The EPA's 2000 Methodology for Deriving Ambient Water Quality 
Criteria for the Protection of Human Health \11\ (2000 Methodology) 
describes the methods the EPA uses when developing national CWA section 
304(a) recommended HHC and when promulgating Federal HHC. The 2000 
Methodology also serves as guidance to states and authorized Tribes for 
developing their own HHC. The EPA's 2000 Methodology informs, but does 
not dictate, the EPA's implementation of the applicable statutory and 
regulatory requirements noted above. The EPA's 2000 Methodology 
recommends that HHC be designed to reduce the risk of adverse cancer 
and non-cancer health effects occurring from lifetime exposure to 
pollutants through the ingestion of drinking water and consumption of 
fish/shellfish obtained from inland and nearshore waters. Consistent 
with the 2000 Methodology, the 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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    \11\ USEPA. (October 2000). Methodology for Deriving Ambient 
Water Quality Criteria for the Protection of Human Health. 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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    Consistent with the EPA's 2000 Methodology, the EPA establishes HHC 
based on two types of toxicological endpoint categories: (1) 
carcinogenicity; and (2) noncancer toxicity (i.e., all adverse effects 
other than cancer). Where sufficient data are available, the EPA 
derives criteria using both carcinogenic and non-carcinogenic toxicity 
endpoints and selects the lower (i.e., more health-protective) value 
for the HHC. The EPA calculates HHC for carcinogenic effects using the 
following input parameters: cancer slope factor (CSF), cancer risk 
level (CRL), body weight, drinking water intake rate, fish consumption 
rate (FCR), and a bioaccumulation factor(s). The EPA calculates HHC for 
both non-cancer and nonlinear carcinogenic effects using a reference 
dose (RfD) and relative source contribution (RSC) in place of a CSF and 
CRL (the remaining inputs are the same for both toxicology endpoints). 
The RSC is applied to apportion the RfD among the media and exposure 
routes of concern for a particular chemical to ensure that an 
individual's total or aggregate exposure from all exposure sources does 
not exceed the RfD.\12\ Each of these inputs is discussed in more 
detail in Sections III.B.1 through III.B.4 of this preamble and in the 
EPA's 2000 Methodology.\13\
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    \12\ While the FCR input is based on fish and shellfish from 
inland and nearshore waters, the RSC component accounts for other 
exposures where relevant, including from consumption of other 
species (e.g., reptiles, birds, marine fish). Alternatively, 
consumption of these other species could be included in the FCR 
input if data are available to determine the consumption rates and 
the associated bioaccumulation factor(s) for these other species. If 
the FCR includes additional species beyond fish and shellfish from 
inland and nearshore waters, EPA recommends that states adjust the 
RSC component accordingly.
    \13\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. 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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1. Cancer Risk Level
    Consistent with the 2000 Methodology, the EPA generally assumes, in 
the absence of data to indicate otherwise, that carcinogens exhibit 
linear ``non-threshold'' dose-responses which means that there are no 
``safe'' or ``no-effect'' levels. Therefore, the EPA calculates HHC for 
carcinogenic effects as pollutant concentrations corresponding to 
lifetime increases in the risk of developing cancer. The EPA calculates 
national recommended HHC using a CRL of 10-6 (one in one 
million) and recommends that states and authorized Tribes use CRLs of 
10-6 or 10-5 (one in one hundred thousand) when 
deriving HHC for the general population.\14\ The EPA notes that states 
and authorized Tribes can also choose a more health protective risk 
level, such as 10-7 (one in ten million), when deriving HHC.
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    \14\ The EPA's 2000 Methodology also states: ``Criteria based on 
a 10-5 risk level are acceptable for the general 
population as long as states and authorized tribes ensure that the 
risk to more highly exposed subgroups (sport fishers or subsistence 
fishers) does not exceed the 10-4 level.''
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2. Cancer Slope Factor and Reference Dose
    For carcinogenic effects, the 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, the EPA uses a 
chronic-duration oral 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. 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 the EPA's 2015 recommended 
304(a) HHC, the EPA's Integrated Risk Information

[[Page 85533]]

System (IRIS) \15\ was the source of both cancer and noncancer toxicity 
values (i.e., RfD and CSF).\16\ For some pollutants, the EPA selected 
risk assessments produced by other EPA program offices (e.g., Office of 
Pesticide Programs), other national and international programs, and 
state programs.
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    \15\ USEPA. Integrated Risk Information System (IRIS). https://www.epa.gov/iris.
    \16\ USEPA. 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. https://www.epa.gov/wqc/human-health-water-quality-criteria.
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3. Exposure Assumptions
    The EPA's general population default exposure assumptions provide 
an overall level of protection targeted at the high end of the general 
population, as stated in the 2000 Methodology. The EPA selects a 
combination of high-end and central tendency inputs to the criteria 
derivation equation. Consistent with the 2015 recommended 304(a) HHC, 
for the general population the 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.
    The EPA's national default drinking water intake rate of 2.4 L/day 
represents the per capita estimate of combined direct and indirect 
community water ingestion at the 90th percentile for adults ages 21 and 
older.\17\ The 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.\18\ The EPA's national default 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 health protective principle that each state does 
its share to protect people who consume fish and shellfish that 
originate from multiple jurisdictions.\19\ The EPA calculates 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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    \17\ USEPA. (2011). EPA Exposure Factors Handbook. 2011 edition. 
EPA 600/R-090/052F. https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=236252.
    \18\ USEPA. (2014). Estimated Fish Consumption Rates for the 
U.S. Population and Selected Subpopulations (NHANES 2003-2010). EPA 
820-R-14-002. https://www.epa.gov/sites/default/files/2015-01/documents/fish-consumption-rates-2014.pdf.
    \19\ USEPA. (2013). Human Health Ambient Water Quality Criteria 
and Fish Consumption Rates: Frequently Asked Questions. https://www.epa.gov/sites/default/files/2015-12/documents/hh-fish-consumption-faqs.pdf.
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    For subsistence fishers, EPA recommends a default FCR of 142 g/day 
in the absence of local data.\20\ This rate is the estimated 99th 
percentile FCR from the 1994-96 Continuing Survey of Food Intake by 
Individuals (CSFII) conducted by the U.S. Department of 
Agriculture.\21\ The EPA's 2000 Methodology noted that at the time, 142 
g/day was ``representative of average rates for highly exposed groups 
such as subsistence fishermen, specific ethnic groups, or other highly 
exposed people.'' \22\
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    \20\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf at 1-13.
    \21\ Jacobs, H.L., Kahn, H.D., Stralka, K.A., and Phan, D.B. 
(1998). Estimates of per capita fish consumption in the U.S. based 
on the continuing survey of food intake by individuals (CSFII). Risk 
Analysis: An International Journal 18(3).
    \22\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf at 4-27.
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    Prior to publication of the 2000 Methodology, in which the EPA 
began recommending the use of BAFs to reflect the uptake of a 
contaminant from all sources by fish and shellfish,\23\ the 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, the 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.'' \24\ For that reason, 
the EPA observed that ``[f]or highly persistent and bioaccumulative 
chemicals that are not easily metabolized, BCFs do not reflect what the 
science indicates.'' \25\ Therefore, consistent with the 2000 
Methodology, when data are available, the EPA uses measured or 
estimated BAFs. BAFs account for chemical accumulation in aquatic 
organisms from all potential exposure routes, including, but not 
limited to, food, sediment, and water.\26\ The EPA uses separate BAFs 
for each trophic level to account for potential biomagnification of 
chemicals in aquatic food webs, as well as physiological differences 
among organisms that may affect bioaccumulation.\27\
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    \23\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. 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.'').
    \24\ USEPA. Revisions to the Methodology for Deriving Ambient 
Water Quality Criteria for the Protection of Human Health (2002), 65 
FR 66444, 66475 (November 3, 2000).
    \25\ Id.
    \26\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf.
    \27\ 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. EPA-822-B-03-030. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000-volume2.pdf.
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    The EPA derives national default BAFs, in part, as a resource for 
states and authorized Tribes with limited resources for deriving site-
specific BAFs.\28\ The 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 recommended 304(a) HHC update, 
the 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.\29\ If this information 
was not available, the EPA selected octanol-water partition 
coefficients (Kow values; i.e., the ratio of a pollutant's 
solubility in fat vs. water)

[[Page 85534]]

from publicly available, published peer-reviewed sources for use in 
calculating national BAFs. As an additional line of evidence, the EPA 
reported model-estimated BAFs for every chemical to support the field-
measured or predicted BAFs.\30\
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    \28\ USEPA. Revisions to the Methodology for Deriving Ambient 
Water Quality Criteria for the Protection of Human Health (2002), 65 
FR 66444 (November 3, 2000).
    \29\ USEPA. 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. https://www.epa.gov/wqc/human-health-water-quality-criteria.
    \30\ Id.
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    Finally, although the EPA uses national default exposure-related 
input values to calculate national CWA section 304(a) recommended 
criteria, the EPA's methodology encourages states to use 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.\31\ Where sufficient 
data are available, selecting a FCR that reflects consumption that is 
unsuppressed by factors such as concerns about the safety of available 
fish furthers the restoration goals of the CWA and ensures protection 
of human health as pollutant levels decrease and fish habitats and 
populations are restored.\32\
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    \31\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf.
    \32\ 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.''). 
National Environmental Justice Advisory Council. (2002). Fish 
Consumption and Environmental Justice at 44, 46. https://www.epa.gov/sites/default/files/2015-02/documents/fish-consump-report_1102.pdf (``NEJAC Fish Consumption Report'').
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4. Relative Source Contribution
    The inclusion of an RSC \33\ is important for protecting public 
health from exposure to certain chemicals from multiple sources and 
routes. When deriving HHC for non-carcinogens and nonlinear 
carcinogens, the EPA recommends including an RSC 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 the 
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 (toxic threshold 
level) and helps prevent adverse health effects from exposure to a 
given chemical over a person's lifetime. The EPA's 2000 Methodology 
\34\ 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 noted in the EPA's January 2023, EPA Legal Tools to Advance 
Environmental Justice: Cumulative Impacts Addendum,\35\ the RSC is one 
way that the EPA considers aggregate chemical exposure to potentially 
affected communities, including communities with environmental justice 
concerns.
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    \33\ ``The RSC is the percentage of total exposure to a 
pollutant attributed to drinking water and eating fish and 
shellfish.'' USEPA. May 2023 Virtual WQS Academy: Human Health 
Ambient Water Quality Criteria. https://www.epa.gov/system/files/documents/2023-06/06_HumanHealthCriteri_Pres_VirtualWQSA_May2023_508c.pdf.
    \34\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf.
    \35\ USEPA. (2023). EPA Legal Tools to Advance Environmental 
Justice: Cumulative Impacts Addendum. Publication No.: 360R22002. 
https://www.epa.gov/system/files/documents/2022-12/bh508-Cumulative%20Impacts%20Addendum%20Final%202022-11-28.pdf.
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C. History of Florida's Human Health Criteria

1. Florida's Existing Human Health Criteria for Priority Toxic 
Pollutants
    Florida elected to comply with CWA section 303(c)(2)(B) by 
following Option 2 in the EPA's 1988 Guidance.\36\ In accordance with 
Option 2, in 1992 Florida adopted HHC for 43 priority toxic pollutants 
that it determined were present or discharged, and could reasonably be 
expected to interfere with designated uses, utilizing EPA-recommended 
procedures and science available at that time.\37\ Additionally, the 
EPA promulgated HHC for Florida for the priority toxic pollutant dioxin 
in its 1992 National Toxics Rule (40 CFR 131.36).
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    \36\ USEPA. (December 1988). Transmittal of Final ``Guidance for 
State Implementation for Water Quality Standards under CWA Section 
303(c)(2)(B).'' https://www.epa.gov/sites/production/files/2014-10/documents/cwa303c-hanmer-memo.pdf.
    \37\ USEPA. (1991). Amendments to the Water Quality Standards 
Regulation to Establish the Numeric Criteria for Priority Toxic 
Pollutants Necessary to Bring All States Into Compliance With 
Section 303(c)(2)(B), 56 FR 58420, November 19, 1991. https://www.epa.gov/sites/production/files/2015-06/documents/ntr-proposal-1991.pdf; see also USEPA. Establishment of Numeric Criteria for 
Priority Toxic Pollutants, 57 FR 60848, 60853 (December 22, 1992).
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    Florida's existing HHC apply to four classifications of waterbodies 
in the state with potable water supply and fish consumption uses 
(Chapter 62-302, Florida Administrative Code):

--Class I--Potable Water Supplies;
--Class II--Shellfish Propagation or Harvesting;
--Class III--Fish Consumption; Recreation, Propagation and Maintenance 
of a Healthy, Well-Balanced Population of Fish and Wildlife; or
--Class III--Limited--Fish Consumption; Recreation or Limited 
Recreation; and/or Propagation and Limited Maintenance of a Limited 
Population of Fish and Wildlife.

    In 1992, EPA recommended a national default FCR of 6.5 g/day, based 
on the average per-capita consumption rate of fish from inland and 
nearshore waters for the U.S. population, for states to consider 
inputting into their calculation of HHC. Florida used this national 
default 6.5 g/day FCR, which was not based on any Florida-specific 
data, to derive its HHC in 1992 and did not subsequently revise those 
HHC. As noted above in Section III.B.3. of this preamble, the EPA's 
national default FCR for the general U.S. adult population 21 years of 
age and older is now 22 g/day.
2. Florida's Actions To Reexamine Its Existing Human Health Criteria
    In accordance with CWA section 303(c)(1) and 40 CFR 131.20, Florida 
is required to review all of its applicable WQS, including its existing 
HHC, at least once every three years and, if appropriate, revise those 
WQS or adopt new WQS. This includes evaluating whether its existing HHC 
should be updated to account for more recent data on FCRs, and whether 
additional priority toxic pollutants are now present in or discharged 
to Florida's waters such that new HHC for those pollutants are 
warranted.\38\
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    \38\ See 40 CFR 131.20 (``State review and revision of water 
quality standards''); 40 CFR 131.11(a)(2) (``States must review 
water quality data and information on discharges to identify 
specific water bodies where toxic pollutants may be adversely 
affecting water quality or the attainment of the designated water 
use or where the levels of toxic pollutants are at a level to 
warrant concern and must adopt criteria for such toxic pollutants 
applicable to the water body sufficient to protect the designated 
use.'')

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[[Page 85535]]

    In 2016, Florida conducted a review of its criteria using updated 
science including updated FCRs based on state- and region-specific 
data.\39\ In particular, Florida found in 2016 that ``more recent fish 
consumption survey information indicates that consumption patterns have 
changed over time, necessitating a re-evaluation of the criteria.'' 
\40\ As an example, Florida cited a 1994 FCR study of Florida residents 
that ``suggested that Floridians eat significantly more fish than 
[EPA's 1992 national default FCR of 6.5 g/day].'' \41\ In addition, in 
response to public comments, in 2016 Florida evaluated the majority of 
the priority toxic pollutants for which the EPA has national 
recommendations, and documented the uses of each chemical, data on 
concentrations of each of the pollutants in Florida's waters and fish, 
and information on environmental releases of those pollutants in 
Florida and neighboring states.\42\ As a result of this review, Florida 
determined that new HHC for 36 priority toxic pollutants were 
warranted.\43\
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    \39\ Florida Department of Environmental Protection. (2016). 
Technical Support Document: Derivation of Human Health-Based 
Criteria and Risk Impact Statement. https://floridadep.gov/sites/default/files/HH_TSD.pdf. Note that Florida's 2016 Technical Support 
Document refers to 43 revised HHC and 39 new HHC; however, a small 
subset of the HHC in each of those groups were for non-priority 
toxic pollutants.
    \40\ Id.
    \41\ Id.
    \42\ Id. at 5-7.
    \43\ Id.
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    Florida's 2016 revised and new HHC were never finalized or 
submitted to the EPA. Then in 2018, Florida initiated a rulemaking to 
consider proposed revisions to its HHC, stating its intent to conduct a 
state-wide fish consumption survey ``to accurately determine the amount 
and types of fish commonly eaten by Floridians in advance of criteria 
development and adoption.'' \44\ However, the survey plans were 
disrupted and ultimately terminated.\45\
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    \44\ Florida Department of Environmental Protection. (February 
9, 2018). Notice of Development of Rulemaking: 62-302.530--Surface 
Water Quality Criteria. https://www.flrules.org/Gateway/View_notice.asp?id=20029450 (last accessed September 9, 2022).
    \45\ Florida Department of Environmental Protection. Fish 
Consumption Survey Project. https://floridadep.gov/dear/water-quality-standards/content/fish-consumption-survey-project (last 
accessed September 15, 2022).
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3. December 1, 2022, Administrator's Determination That Florida's 
Existing Health Criteria for Priority Toxic Pollutants Are Not 
Protective of Its Designated Uses
    Based on the information above, on December 1, 2022, the EPA issued 
an Administrator's Determination that new and revised HHC for Florida 
were necessary pursuant to CWA section 303(c)(4)(B).\46\ As the EPA 
stated in that determination, one of the primary deficiencies with 
Florida's existing HHC is their reliance on the EPA's national default 
FCR from 1992. As Florida has acknowledged, its existing HHC are based 
on an FCR that is far lower than national, regional or state-specific 
studies suggest Floridians consume.\47\ This finding is consistent with 
the EPA's 2014 analysis of NHANES data from 2003 to 2010, which 
indicates that the 90th percentile consumption rate of fish and 
shellfish from Florida's inland and nearshore waters ranges from 
approximately 22 g/day to 30 g/day.\48\ In 2016, Florida used these 
same data from the EPA's 2014 report \49\ as the basis for the FCRs to 
derive the HHC that the state ultimately did not finalize.\50\
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    \46\ Letter from Radhika Fox, Assistant Administrator of the EPA 
Office of Water, to Shawn Hamilton, Secretary of the Florida 
Department of Environmental Protection, Re: EPA's Administrator's 
Determination that new and revised water quality standards in 
Florida are necessary to satisfy the requirements of the CWA 
(December 1, 2022) (Administrator's Determination or Determination).
    \47\ Florida Department of Environmental Protection. (2016). 
Technical Support Document: Derivation of Human Health-Based 
Criteria and Risk Impact Statement. https://floridadep.gov/sites/default/files/HH_TSD.pdf at 2 (``At the time the criteria were first 
adopted, the U.S. EPA assumed fish consumption and surface water 
drinking rates of 6.5 g/day and 2.0 L/day, respectively. The HHC 
currently listed in Rule 62-302.530, F.A.C., were developed based on 
these point values. However, more recent fish consumption survey 
information indicates that consumption patterns have changed over 
time, necessitating a re-evaluation of the criteria.'').
    \48\ USEPA. (2014). Estimated Fish Consumption Rates for the 
U.S. Population and Selected Subpopulations (NHANES 2003-2010), EPA 
820-R-14-002. https://www.epa.gov/sites/default/files/2015-01/documents/fish-consumption-rates-2014.pdf.
    \49\ Id.
    \50\ Florida Department of Environmental Protection. (2016). 
Technical Support Document: Derivation of Human Health-Based 
Criteria and Risk Impact Statement. https://floridadep.gov/sites/default/files/HH_TSD.pdf.
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    Regarding new HHC, the EPA determined that Florida needs new HHC 
for 37 additional priority toxic pollutants. Available information 
included in the state's rulemaking record and other state actions 
related to priority toxic pollutants \51\ indicates that more of these 
pollutants are likely present in state waters than originally 
understood in 1992. As the EPA has explained, ``the criteria 
development and the standards programs are iterative,'' and states are 
expected to adopt ``criteria for additional toxic pollutants . . . 
which new information indicates is appropriate.'' \52\ These additional 
HHC are necessary in order to ensure that the state's designated uses 
are protected.
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    \51\ See Florida Department of Environmental Protection (October 
24, 2013). Final Report: Mercury TMDL for the State of Florida. 
https://floridadep.gov/sites/default/files/Mercury-TMDL.pdf.
    \52\ 57 FR 60848 at 60873, December 22, 1992.
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IV. Derivation of Human Health Criteria for Florida

A. Scope of EPA's Proposal

    In the process of developing this proposed rulemaking, the EPA 
concluded that there are instances where Florida's existing HHC for 
certain pollutants listed in EPA's December 1, 2022, Administrator's 
Determination are as stringent as or more stringent than the HHC the 
EPA found would be protective of the state's designated uses and based 
on sound scientific rationale, using the approaches and inputs outlined 
below. CWA section 510 (33 U.S.C. 1370) preserves the authority of 
states to adopt more stringent standards than otherwise required by the 
CWA, and, pursuant to 40 CFR 131.21(c), EPA-approved WQS remain in 
effect ``unless or until EPA has promulgated a more stringent water 
quality standard.'' (Emphasis added). Therefore, the EPA is not 
proposing Federal HHC where Florida's existing HHC are as stringent as 
or more stringent than the HHC that the EPA calculated using the 
approaches and inputs below, consistent with CWA requirements and the 
EPA's implementing regulations, specifically 40 CFR 131.11.
    As noted in Section III.C.1 of this preamble, the EPA promulgated 
HHC for Florida for the priority toxic pollutant dioxin in its 1992 
National Toxics Rule (40 CFR 131.36). For clarity in organization, the 
EPA is proposing to withdraw Florida from 40 CFR 131.36 and to 
incorporate Florida's CWA-effective dioxin criteria from the National 
Toxics Rule into this rulemaking so there would be a single 
comprehensive set of federally promulgated HHC for Florida. The EPA is 
not proposing to revise Florida's CWA-effective dioxin criteria from 
the National Toxics Rule; this proposal to move Florida's existing 
dioxin criteria into this rulemaking is purely administrative. The EPA 
did not determine in the agency's December 1,

[[Page 85536]]

2022, Administrator's Determination that revised dioxin HHC were needed 
in Florida and any substantive comments on HHC for dioxin in Florida 
would be outside the scope of this rulemaking.
    The final criteria resulting from this proposed rulemaking would 
supersede the state's corresponding HHC for these pollutants. The HHC 
in this proposed rulemaking, including the new Federal HHC for 
pollutants where Florida lacks any corresponding HHC, would apply to 
surface waters in the state of Florida, excluding waters within Indian 
country.\53\
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    \53\ See 18 U.S.C. 1151 for definition of Indian Country.
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B. Tribal Reserved Rights Applicable to Florida's Waters

    In accordance with EPA's 2016 Policy on Consultation and 
Coordination with Indian Tribes: Guidance for Discussing Tribal Treaty 
Rights,\54\ the EPA initiated consultation with Tribes that may be 
affected by this proposed rulemaking to seek information and 
recommendations about any Tribal reserved rights applicable to 
Florida's waters. Based on information shared with and reviewed by the 
EPA, and as set forth in the docket for this proposed rule, the agency 
understands that the two federally recognized Tribes in Florida--the 
Seminole Tribe of Florida and the Miccosukee Tribe of Indians of 
Florida--hold federally reserved rights to hunt, fish, and trap on a 
subsistence basis and for use in traditional Tribal ceremonials in Big 
Cypress National Preserve and Everglades National Park.\55\ The 
Miccosukee Tribe also has the right to hunt and fish for subsistence 
purposes and to take frogs for food and for commercial purposes in the 
lands it leases from the state of Florida within Water Conservation 
Area 3A (WCA-3A).\56\ The Seminole Tribe has the right to hunt, trap, 
fish and frog in the portions of WCA-3A that it transferred to the 
state of Florida pursuant to a 1987 agreement.\57\ The docket for this 
rulemaking includes copies of the Federal laws and other documents that 
reflect these reserved rights. It also includes a map depicting, as of 
the date of publication of this proposed rulemaking, the areas with 
reserved rights based on the relevant statutes and related documents 
provided by the Tribes, Tribal reservation and trust lands, and 
associated geographical information system (GIS) layers. The EPA 
requests comment on whether these maps accurately reflect the relevant 
reserved rights.
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    \54\ See USEPA. (2016). EPA Policy on Consultation and 
Coordination with Indian Tribes: Guidance for Discussing Tribal 
Treaty Rights. https://www.epa.gov/sites/default/files/2016-02/documents/tribal_treaty_rights_guidance_for_discussing_tribal_treaty_rights.pdf
.
    \55\ 16 U.S.C. 698(j); 16 U.S.C. 410(b). The Miccosukee Tribe of 
Indians of Florida was originally part of the Seminole Tribe, but 
the Tribes split due to disagreements over dealings with the United 
States government. See Miccosukee Tribe of Indians of Fla. v. United 
States, 716 F.3d 535, 545 n.21 (11th Cir. 2013). In 1957, the 
Seminole became a federally-recognized Tribe. In 1962, the Federal 
government distinguished between the Seminole and the Miccosukee 
Tribes, and granted the Miccosukee Federal recognition. Id. at 547. 
Therefore, references to the ``Seminole Indians'' in the Everglades 
National Park Enabling Act can be construed to also pertain to the 
present-day Miccosukee Tribe of Indians of Florida.
    \56\ 25 U.S.C. 1741 et seq. (``Florida Indian (Miccosukee) Land 
Claims Settlement Act'' or ``FILCSA''), Public Law 97-399, 96 Stat. 
2012 (1982).
    \57\ 25 U.S.C. 1772 et seq. (``Florida Indian (Seminole) Land 
Claims Settlement Act'' or ``SILCSA''), Public Law 100-228, 101 
Stat. 1556 (1987).
---------------------------------------------------------------------------

    As noted in Section III.B. of this preamble, HHC are designed to 
protect humans from lifetime exposure to pollutants through the 
ingestion of drinking water and consumption of fish/shellfish obtained 
from inland and nearshore waters. The RSC component accounts for 
sources of exposure other than drinking water and consumption of fish 
and shellfish from inland and nearshore waters (e.g., consumption of 
frogs and other foods, dermal and inhalation exposure, and other 
potential exposure sources/routes). The specific Tribal reserved rights 
that the EPA has concluded could be affected by this HHC rulemaking in 
Florida are the Seminole Tribe's and Miccosukee Tribe's reserved rights 
to fish for subsistence purposes and to take frogs for food. The EPA 
requests comment on this conclusion. While Florida has other types of 
criteria in place that are relevant to protection of the aquatic and 
aquatic-dependent resources that the Seminole Tribe and Miccosukee 
Tribe may hunt and trap pursuant to their reserved rights (e.g., 
amphibians, reptiles, birds, and mammals), those other types of 
criteria are not the subject of, nor are they affected by, this 
rulemaking. See Section IV.C.1. of this preamble for a discussion of 
how the EPA considered the Tribes' rights to fish for subsistence 
purposes and to take frogs for food in certain waters in Florida when 
selecting the FCR input to derive the proposed HHC in this rulemaking.

C. Human Health Criteria Inputs

1. Fish Consumption Rate
a. General Population Rate
    As discussed, both state-specific and national data show that fish 
consumption rates within the state have increased since Florida first 
established its existing HHC.\58\ For protection of the general 
population in all waters of the state except in those waters where the 
Seminole Tribe and Miccosukee Tribe have reserved rights to fish for 
their subsistence, EPA proposes to derive new and revised HHC for 
Florida using the national default FCR of 22 g/day (comprised of 8, 9 
and 5 g/day for consumption of trophic level 2, 3, and 4 fish, 
respectively).\59\ The selected FCR is based on consideration of the 
following information:

    \58\ Florida Department of Environmental Protection. (2016). 
Technical Support Document: Derivation of Human Health-Based 
Criteria and Risk Impact Statement. https://floridadep.gov/sites/default/files/HH_TSD.pdf.
    \59\ USEPA. (2014). Estimated Fish Consumption Rates for the 
U.S. Population and Selected Subpopulations (NHANES 2003-2010). EPA 
820-R-14-002. https://www.epa.gov/sites/default/files/2015-01/documents/fish-consumption-rates-2014.pdf.

 A 1994 state-specific study, Per Capita Fish and Shellfish 
Consumption in Florida \60\
---------------------------------------------------------------------------

    \60\ Degner et al. (1994). Per Capita Fish and Shellfish 
Consumption in Florida. Florida Agricultural Market Research Center, 
University of Florida.
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 The EPA's 2014 analysis of 2003-2010 NHANES data. \61\

    \61\ USEPA. (2014). Estimated Fish Consumption Rates for the 
U.S. Population and Selected Subpopulations (NHANES 2003-2010), EPA 
820-R-14-002. https://www.epa.gov/sites/default/files/2015-01/documents/fish-consumption-rates-2014.pdf.

    The only state-specific FCR study the EPA is aware of is a 1994 
study funded by the Florida Department of Environmental Protection 
(Florida DEP) and conducted by Dr. Robert Degner of the University of 
Florida.\62\ This study reported average FCRs ranging from 
approximately 20-60 g/day for different population groups in the state. 
While Florida used this comprehensive 1994 study to inform its 2016 
HHC, the state ultimately decided that it could not use it as the sole 
basis for determining a Florida-specific FCR, in large part because the 
1994 study had been superseded by newer data and study methodologies. 
The EPA has similarly concluded that it would be preferable to select a 
FCR based on newer data and methodologies and therefore is not 
proposing to use the 1994 study to calculate the HHC in this 
rulemaking. However, the EPA notes that its selected FCR of 22 g/day is 
within the range of FCRs from the 1994 study.
---------------------------------------------------------------------------

    \62\ Degner et al. (1994). Per Capita Fish and Shellfish 
Consumption in Florida. Florida Agricultural Market Research Center, 
University of Florida.
---------------------------------------------------------------------------

    As mentioned above, the EPA's national default general population 
FCR of 22 g/day represents the 90th

[[Page 85537]]

percentile consumption rate of fish and shellfish from inland and 
nearshore waters for the U.S. adult population 21 years of age and 
older and is based on the EPA's analysis of NHANES data from 2003 to 
2010.\63\ The EPA also analyzed the 2003-2010 NHANES data based on 
geographic areas in the U.S., four of which are relevant to the 
selection of a FCR for Florida.\64\ Each of these FCRs are based on the 
consumption of fish and shellfish from inland and nearshore waters for 
adults 21 years of age and older. The 90th percentile FCR for those 
living in the South is 26.3 g/day. The 90th percentile FCR for those 
living in the Atlantic Coast region--or coastal counties in the 16 
states that border the Atlantic Coast--is 30.8 g/day. The 90th 
percentile FCR for those living in the Gulf of Mexico Coast region--
those coastal counties in the five states that border the Gulf of 
Mexico--is 28.6 g/day. Finally, the 90th percentile FCR for those 
living in the Inland South region--the remaining non-coastal counties 
in the South--is 22.8 g/day. While each of these FCRs is likely 
representative of certain areas in Florida, the EPA concluded that they 
were not different enough from the EPA's national default FCR of 22 g/
day to warrant the increased uncertainty that these smaller geographic-
specific datasets would introduce.\65\ Therefore, the EPA is proposing 
to use the national default FCR of 22 g/day to calculate HHC in this 
rule to protect the general population in the state. The EPA requests 
comment on whether it should consider using one of the geographic-
specific FCRs to derive HHC for Florida, and if so, how the EPA should 
account for the smaller sample sizes and associated uncertainty.
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    \63\ USEPA. (2014). Estimated Fish Consumption Rates for the 
U.S. Population and Selected Subpopulations (NHANES 2003-2010), EPA 
820-R-14-002. https://www.epa.gov/sites/default/files/2015-01/documents/fish-consumption-rates-2014.pdf.
    \64\ See Id. p. 7-8 for which states comprise each region, based 
on the regions as defined by the U.S. Census Bureau.
    \65\ The 95% confidence interval increases as the sample size 
decreases. In all but one instance, the 95% confidence interval 
associated with the national default FCR (19.1-25.4 g/day) overlaps 
with the 95% confidence interval for the geographic regions relevant 
to Florida, suggesting that the geographic-specific FCRs may not be 
meaningfully different from the national default FCR: (South (21.6-
32 g/day), Atlantic (25.3-37.5 g/day), Gulf of Mexico (22.5-36.4) 
and Inland South (18.6-27.9).
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b. Subsistence Rate
    For protection of subsistence consumers in the geographic areas 
where the Seminole Tribe and Miccosukee Tribe have reserved rights to 
fish for subsistence purposes and to take frogs for food, the EPA 
proposes to derive new and revised HHC for Florida using the national 
default subsistence FCR of 142 g/day.\66\ The selected FCR is based on 
consideration of the following information, which the EPA discusses in 
turn below:
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    \66\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. UEPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf at 1-13. EPA proposes to 
apply the same ratios of trophic level-specific consumption to the 
142 g/day as to the 22 g/day. For the 142 g/day total consumption 
rate, the trophic level-specific consumption rates for trophic 
levels 2, 3, and 4 are 52, 58 and 32 g/day, respectively.

 A 2016 Seminole Tribe of Florida Tissue Contaminant Study for 
Big Cypress and Brighton Reservations \67\
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    \67\ USEPA. (2016). Seminole Tribe of Florida Tissue Contaminant 
Study for Big Cypress and Brighton Reservations. U.S. Environmental 
Protection Agency, Region 4, Science and Ecosystem Support Division. 
SESD Project ID #: 16-0380.
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 A 2017 Evaluation of Heritage Aquatic Species Consumption 
Rates for the Seminole Tribe of Florida \68\
---------------------------------------------------------------------------

    \68\ Ridolfi Environmental. (2017). Evaluation of Heritage 
Aquatic Species Consumption Rates, Seminole Tribe of Florida.
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 The EPA's 2000 default FCR for subsistence fishers \69\
---------------------------------------------------------------------------

    \69\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf.

    In 2016, EPA Region 4 published the report Seminole Tribe of 
Florida Tissue Contaminant Study for Big Cypress and Brighton 
Reservations, which had been requested by the Seminole Tribe.\70\ The 
study analyzed fish tissue samples from the Big Cypress and Brighton 
Reservations for toxic pollutants and, based on the level of toxins 
found, proposed species-specific meal frequencies that the Tribe could 
use to post fish consumption advisories. The study used a suggested 
meal size from the EPA's Guidance for Assessing Chemical Contaminant 
Data for Use in Fish Advisories, Volumes 1 and 2 (EPA 823-B-00-007 and 
008) of 227 g. However, the study does not identify a meal frequency to 
pair with the 227 g meal size and therefore the EPA could not determine 
an appropriate FCR from this study. The EPA requests comment on 
whether, as a potential alternative to the proposed default FCR of 142 
g/day, 227 g/day is an appropriate meal size for Tribal subsistence 
consumers in Florida, and if so, whether there are data and information 
to support a meal frequency, such as one or two meals per day, to 
associate with subsistence practices.
---------------------------------------------------------------------------

    \70\ USEPA. (2016). Seminole Tribe of Florida Tissue Contaminant 
Study for Big Cypress and Brighton Reservations. U.S. Environmental 
Protection Agency, Region 4, Science and Ecosystem Support Division. 
SESD Project ID #: 16-0380.
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    The 2017 Ridolfi, Inc. study Evaluation of Heritage Aquatic Species 
Consumption Rates for the Seminole Tribe of Florida identifies heritage 
consumption rates for the Seminole Tribe, based on a literature review 
of historical and ethnographic materials.\71\ A heritage rate is the 
amount of fish consumed prior to non-indigenous or modern sources of 
contamination and interference with the natural lifecycle of fish, in 
addition to changes in human society.\72\ While often thought of as a 
historic rate, heritage rates may be useful in establishing a 
subsistence consumption baseline (i.e., unsuppressed consumption level) 
in areas where Tribes have reserved rights to fish for subsistence 
(such as the case here for the two Tribes in Florida).\73\ The 2017 
Ridolfi, Inc. study estimated a heritage consumption rate of 800 g/day 
for freshwater fish, amphibians and reptiles, and a heritage 
consumption rate of 47 g/day for anadromous fish and marine shellfish.
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    \71\ Ridolfi Environmental. 2017. Evaluation of Heritage Aquatic 
Species Consumption Rates, Seminole Tribe of Florida.
    \72\ USEPA. (2016). Guidance for Conducting Fish Consumption 
Surveys. EPA-823B16002.
    \73\ Id.
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    The EPA is proposing to rely on the default subsistence FCR of 142 
g/day, rather than the heritage rates from the 2017 Ridolfi, Inc. 
study, for the following reasons. First, the 2017 Ridolfi, Inc. study 
focuses solely on historic consumption patterns, and does not contain 
information indicating that the heritage rates in the study are 
consistent with the Tribes' anticipated exercise of their subsistence 
rights moving forward.\74\ Namely, the EPA lacks information indicating 
that these heritage rates reflect the amount of aquatic species that 
the Tribes would actually consume in the absence of factors such as, 
for example, concerns

[[Page 85538]]

about water quality.\75\ Further, a relevant data point regarding the 
Tribes' anticipated future exercise of their rights is the FCR of 
either 17.5 g/day or 22 g/day used by the Tribes in their federally 
approved WQS applicable on their reservations.\76\ Based on information 
obtained through consultation and coordination with both Tribes, 
reflected in the docket for this rulemaking, the EPA does not have 
sufficient information to conclude that the heritage rates identified 
in the 2017 Ridolfi, Inc. study are representative of the anticipated 
exercise of those rights moving forward for both the Seminole Tribe and 
Miccosukee Tribe.
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    \74\ The Tribes' anticipated future exercise of those rights 
could be informed by the importance of fish consumption as a protein 
source as well as realistic potential consumption rates that reflect 
the modern-day availability of alternative protein sources and 
current lifestyles. For example, the EPA approved the Spokane 
Tribe's HHC based on a FCR of 865 g/day. This FCR maintains the 
caloric intake characteristic of a traditional subsistence lifestyle 
while accounting for the lesser quantity and diversity of fish 
currently available to the Tribe as a result of the construction of 
the Grand Coulee Dam. See U.S. EPA Region 10. (December 11, 2013). 
Technical Support Document for Action on the Revised Surface Water 
Quality Standards of the Spokane Tribe of Indians Submitted April 
2010.
    \75\ USEPA. (2016). Guidance for Conducting Fish Consumption 
Surveys. EPA-823B16002.
    \76\ The EPA understands that both Tribes are currently 
considering their plans for each of their next WQS triennial reviews 
and whether revisions to their on-reservation HHC, which are 
currently based on default FCRs that the EPA has recommended for the 
general population, would be warranted. On their own reservations, 
the Tribes are responsible for determining the criteria to protect 
their designated uses, based on a sound scientific rationale. If the 
Tribes were in the future to each develop an FCR to protect 
subsistence fishing on their reservations, such information could 
help inform a future revision to Florida's HHC in the geographic 
areas where the two Tribes have off-reservation reserved rights to 
fish for subsistence purposes and to take frogs for food.
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    Second, as noted in Section III.B.3. of this preamble, in the 2015 
national recommended 304(a) HHC, the EPA developed national BAFs for 
three trophic levels of fish.\77\ These BAFs reflect the uptake of each 
contaminant by fish and shellfish and would not be appropriate to use 
to reflect uptake by amphibians or reptiles. At this time, the EPA does 
not have available data to calculate BAFs for amphibians or reptiles 
for the pollutants of concern in this proposed rulemaking such that the 
agency could utilize the corresponding heritage consumption rates for 
amphibians and reptiles in the 2017 Ridolfi, Inc. study. The EPA 
concluded that its proposed HHC for the geographic areas where the 
Seminole Tribe and Miccosukee Tribe have reserved rights to fish on a 
subsistence basis are health protective because the agency applied an 
RSC of 0.2, which allows for 80% of a chemical's exposure to come from 
sources other than drinking water and inland and nearshore fish and 
shellfish. This health protective approach is consistent with the EPA's 
longstanding practice and peer reviewed 2000 Methodology.\78\
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    \77\ USEPA. 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. https://www.epa.gov/wqc/human-health-water-quality-criteria.
    \78\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. 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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    For these reasons, the EPA is not proposing to use the heritage 
consumption rates from the 2017 Ridolfi, Inc. study to calculate the 
HHC in this rulemaking. The EPA requests comment on whether, as a 
potential alternative to the proposed default FCR of 142 g/day, there 
are data and appropriate methodologies with which to re-evaluate the 
heritage rates based on the anticipated exercise of applicable tribal 
reserved rights moving forward where the two Tribes have reserved 
rights to fish for subsistence purposes and to take frogs for food.
    Finally, as noted above, the EPA's 2000 Methodology recommends a 
default FCR of 142 g/day for subsistence fishers, based on the 1994-
1996 Continuing Survey of Food Intake by Individuals conducted by the 
U.S. Department of Agriculture, in the absence of local data.\79\ Due 
to the lack of local fish consumption data to determine a current 
unsuppressed subsistence FCR, the EPA is proposing to use the default 
subsistence rate for the geographic areas where the Seminole Tribe and 
Miccosukee Tribe have reserved rights to fish for subsistence purposes 
and to take frogs for food. One way to evaluate the reasonableness of 
the default FCR of 142 g/day for application to subsistence rights is 
to consider the nutritional needs of those relying on fish and 
shellfish as a dietary staple. The Recommended Dietary Allowance (RDA) 
for protein intake for nutritional needs is 0.8 g per kg body weight 
per day.\80\ However, research suggests that a protein intake rate of 
1.0 g/kg/day may be more appropriate for older adults.\81\ This rate 
would also benefit individuals who are more physically active 
regardless of age.\82\ Using data for U.S. adults from NHANES for 2007-
2010, researchers found that the percentages of total protein intake 
derived from animal, dairy, and plant protein were 46%, 16%, and 30%, 
respectively (8% of intake could not be classified).\83\ The same study 
found that fish comprise 5% of (non-dairy) animal protein intake (2.5% 
of total protein intake). This puts the high-end of protein intake from 
all animal/dairy sources at 70% (assuming all unclassified protein 
intake is from animal sources). There may be many potential ways to 
determine an appropriate percent of protein from animal sources that 
come from fish as a staple food. A United Nations synthesis study 
highlighted that in certain parts of the world where fish protein is a 
crucial nutritional component and considered a staple, fish contributes 
(or exceeds) 50% of total animal protein intake.\84\ Considering that 
protein comprises approximately 20% of fish wet weight, \85\ then 
putting together the figures cited above yields a subsistence FCR of 
140 g/day (1 g/kg/day protein allowance * 80 kg body weight/20% protein 
content in fish * 70% of protein from all animal/dairy sources * 50% of 
animal protein from fish (for high consuming fish populations)). This 
example calculation provides additional support for using the default 
FCR for subsistence fishers of 142 g/day. Further support is provided 
by the Dietary Guidelines for Americans, which recommends adults 
consume 5-7 ounces of ``protein foods'' daily depending on total 
calorie intake.\86\ Since 142 grams equals 5 ounces, this level of fish 
consumption would reflect 70-100% of this recommendation, consistent 
with use of fish as a staple protein food.
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    \79\ Jacobs, H.L., Kahn, H.D., Stralka, K.A., and Phan, D.B. 
(1998). Estimates of per capita fish consumption in the U.S. based 
on the continuing survey of food intake by individuals (CSFII). Risk 
Analysis: An International Journal 18(3).
    \80\ Institute of Medicine. (2005). Dietary Reference Intakes 
for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, 
protein and amino acids. Washington (DC): National Academies Press.
    \81\ Richter, M., Baerlocher, K., Bauer, J.M., Elmadfa, I., 
Heseker, H., Leschik-Bonnet, E., Stangl, G., Volkert, D., Stehle, P. 
(2019). Revised Reference Values for the Intake of Protein. Annals 
of Nutrition and Metabolism 74(3):242-250.
    \82\ Hudson, J.L., Wang, Y., Bergia, I., R.E., Campbell, WW. 
(2020). Protein Intake Greater than the RDA Differentially 
Influences Whole-Body Lean Mass Responses to Purposeful Catabolic 
and Anabolic Stressors: A Systematic Review and Meta-analysis. 
Advances in Nutrition 11(3):548-558.
    \83\ Pasiakos, S.M., Agarwal, S., Lieberman, H.R., Fulgoni III, 
V.L. (2015). Sources and Amounts of Animal, Dairy, and Plant Protein 
Intake of US Adults in 2007-2010. Nutrients 7(8): 7058-7069.
    \84\ Food and Agriculture Organization of the United Nations 
(FAO). (2014). The state of world fisheries and aquaculture. 
Opportunities and challenges. Rome, Italy.
    \85\ Ahmed, I., Jan, K., Fatma, S., Dawood, M.A.O. (2022). 
Muscle proximate composition of various food fish species and their 
nutritional significance: A review. Journal of Animal Physiology and 
Animal Nutrition. Volume 106, Issue 3 (690-719).
    \86\ U.S. Department of Agriculture and U.S. Department of 
Health and Human Services. (December 2020). Dietary Guidelines for 
Americans, 2020-2025. https://www.dietaryguidelines.gov/sites/default/files/2021-03/Dietary_Guidelines_for_Americans-2020-2025.pdf 
at 96.
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    Additionally, the EPA evaluated whether 142 g/day is still 
representative of current consumption rates for highly exposed groups, 
as noted in the 2000 Methodology. Post-2000 consumption surveys of high 
fish consuming populations (e.g., Tribes and Asian Pacific Islanders) 
resulted in mean FCRs ranging from 18.6 g/day to 233 g/day

[[Page 85539]]

and 90th percentile FCRs ranging from 48.9 g/day to 528 g/day.\87\ 
Therefore, 142 g/day appears to still be representative of current 
consumption rates for certain highly exposed groups, albeit possibly on 
the low end. These data are for illustrative purposes only; the 
surveyed populations cited here are not local to Florida and these 
current consumption rates may be suppressed by fish availability or 
concerns about the safety of available fish.
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    \87\ Polissar, N.L., Salisbury, A., Ridolfi, C., Callahan, K., 
Neradilek, M., Hippe, D.S., and Beckley, W.H. (2016). A Fish 
Consumption Survey of the Nez Perce Tribe. The Mountain-Whisper-
Light Statistics, Pacific Market Research, Ridolfi, Inc. https://www.epa.gov/sites/production/files/2017-01/documents/fish-consumption-survey-nez-perce-dec2016.pdf; Polissar, N.L., Salisbury, 
A., Ridolfi, C., Callahan, K., Neradilek, M., Hippe, D.S., and W.H. 
Beckley. (2016). A Fish Consumption Survey of the Shoshone-Bannock 
Tribes. The Mountain-Whisper-Light Statistics, Pacific Market 
Research, Ridolfi, Inc. https://www.epa.gov/sites/production/files/2017-01/documents/fish-consumption-survey-shoshone-bannock-dec2016.pdf; Seldovia Village Tribe. (2013). Assessment of Cook 
Inlet Tribes Subsistence Consumption. Seldovia Village Tribe 
Environmental Department; Suquamish Tribe. (2000). Fish Consumption 
Survey of The Suquamish Indian Tribe of The Port Madison Indian 
Reservation, Puget Sound Region. Suquamish, W.A.; Sechena, R., Liao, 
S., Lorenzana, R., Nakano, C., Polissar, N., Fenske., R. (2003). 
Asian American and Pacific Islander seafood consumption--a 
community-based study in King County, Washington. J of Exposure 
Analysis and Environ Epidemiology. (13): 256-266; Lance, T.A., 
Brown, K., Drabek, K., Krueger, K., and S. Hales. (2019). Kodiak 
Tribes Seafood Consumption Assessment: Draft Final Report, Sun'aq 
Tribe of Kodiak, Kodiak, AK. https://sunaq.org/wp-content/uploads/2016/09/Kodiak-Tribes-Seafood-Consumption-Assessment-DRAFT-Final-Report-26Feb19-FINAL.pdf.
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2. Body Weight
    The EPA proposes to calculate new and revised HHC for Florida using 
a body weight of 80 kg. As noted above, this represents the average 
weight of a U.S. adult age 21 and older, based on NHANES data from 1999 
to 2006 (see Section III.B.3. of this preamble).
3. Drinking Water Intake
    The EPA proposes to calculate new and revised HHC for Florida using 
a drinking water intake rate of 2.4 L/day. In 2015, the EPA updated its 
national default drinking water intake rate to 2.4 L/day based on 
national survey data (see Section III.B.3. of this preamble). The EPA 
is not aware of any local data applicable to Florida that suggest a 
different rate.
4. Pollutant-Specific Reference Doses and Cancer Slope Factors
    As part of the EPA's 2015 updates to its 304(a) recommended HHC, 
the EPA conducted a systematic search of eight peer-reviewed, publicly 
available sources to obtain the most current toxicity values for each 
pollutant (RfDs for non-carcinogenic effects and CSFs for carcinogenic 
effect).\88\ The EPA proposes to calculate new and revised HHC for 
Florida using the same toxicity values that the EPA used in its 2015 
recommended 304(a) HHC update, to ensure that the resulting criteria 
are based on a similar, sound scientific rationale.\89\
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    \88\ USEPA. (June 29, 2015). Final Updated Ambient Water Quality 
Criteria for the Protection of Human Health, 80 FR 36986. See also 
USEPA. (2015). Final 2015 Updated National Recommended Human Health 
Criteria. https://www.epa.gov/wqc/national-recommended-water-quality-criteria-human-health-criteria-table.
    \89\ While there may be new toxicity information available for 
certain pollutants that is not yet reflected in the EPA's CWA 
section 304(a) national recommended HHC, such information has not 
yet been reviewed through the EPA's CWA section 304(a) criteria 
development process and therefore is not incorporated into this 
proposal. For example, there is new toxicity information available 
for benzo(a)pyrene, the index PAH used to derive the toxicity values 
for six other PAHs. The EPA is considering this new toxicity 
information. Once EPA has developed updated CWA section 304(a) 
criteria for these pollutants, the State should evaluate its HHC for 
these pollutants during its next triennial review. See 40 CFR 
131.20(a).
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    For benzene, the EPA's 2015 304(a) recommended HHC are presented as 
a range, based on a range of CSFs. In this rule, the EPA proposes to 
use the upper end of the range of CSFs to derive the HHC for benzene as 
the approach resulting in the most health-protective value. EPA 
requests comment on this decision.
    Where the EPA did not update criteria for certain pollutants in 
2015, the EPA proposes to use the toxicity values that the agency used 
the last time it updated its 304(a) criteria for those pollutants as 
the best available scientific information. For beryllium, where the EPA 
has no 304(a) recommended HHC,\90\ the EPA calculated draft HHC using 
the most recent toxicity value from IRIS, which is an RfD from 
1998.\91\ This is consistent with the approach that Florida was 
proposing to follow in 2016.\92\ When using the 1998 RfD for beryllium, 
in conjunction with the other inputs described above and below, the 
resulting HHC are less stringent than Florida's existing HHC for 
beryllium. Therefore, as noted above consistent with CWA section 510, 
EPA is not proposing Federal HHC for beryllium in this rule. See Table 
1 of this preamble, columns B1 and B3 for a list of pollutant-specific 
toxicity factors that the EPA proposes to use to calculate new and 
revised HHC for Florida. If the resulting draft HHC values are less 
stringent than Florida's existing HHC, those values are noted with an 
asterisk in Table 1 of this preamble and are excluded from the EPA's 
proposed HHC.
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    \90\ The EPA issued a recommended HHC for beryllium in 1980 
(USEPA. [October 1980]. Ambient Water Quality Criteria for 
Beryllium. EPA 440 5-80-024) but then withdrew that HHC 
recommendation in the 1992 National Toxics Rule (USEPA. [December 
1992]. Establishment of Numeric Criteria for Priority Toxic 
Pollutants, 57 FR 60848, December 22, 1992). The EPA cited the need 
to further evaluate whether beryllium in water could pose a 
carcinogenic risk to humans as the basis for the withdrawal. The EPA 
calculated the HHC for beryllium using the non-carcinogenic endpoint 
(i.e., the RfD) for the purposes of this rulemaking.
    \91\ USEPA. IRIS Assessments: Beryllium and compounds. https://iris.epa.gov/ChemicalLanding/&substance_nmbr=12 (last accessed July 
5, 2023).
    \92\ Florida Department of Environmental Protection. (2016). 
Technical Support Document: Derivation of Human Health-Based 
Criteria and Risk Impact Statement. https://floridadep.gov/sites/default/files/HH_TSD.pdf.
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5. Cancer Risk Level
    The EPA proposes to derive HHC for Florida using a CRL of 
10-6 for all pollutants and for all waters in the state, 
including waters where Tribes have reserved rights to fish on a 
subsistence basis. The EPA's selection of a 10-6 CRL is 
consistent with EPA's 2000 Methodology, which states that the EPA 
intends to use the 10-6 level when promulgating water 
quality criteria for states and Tribes.\93\ In addition, Florida's 
existing HHC are based on a 10-6 CRL.\94\
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    \93\ EPA 2000 Methodology, p. 2-6. The Methodology recommends 
that states set human health criteria CRLs for the target general 
population at either 10-5 or 10-6 (p. 2-6) and 
also notes that states and authorized tribes can always choose a 
more stringent risk level, such as 10-7 (p. 1-12).
    \94\ Florida Department of Environmental Protection. (2016). 
Technical Support Document: Derivation of Human Health-Based 
Criteria and Risk Impact Statement. https://floridadep.gov/sites/default/files/HH_TSD.pdf at 11.
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    Moreover, as noted above, the Miccosukee Tribe and Seminole Tribe 
have reserved rights to fish for subsistence in certain waters of the 
state. The EPA's selection of a 10-6 CRL ensures that Tribal 
members exercising their legal rights to harvest and consume fish and 
shellfish at subsistence levels are protected to the same risk level as 
the general population is protected in other state waters.
6. Relative Source Contribution
    When developing national recommended HHC, the EPA applies 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.4. of this preamble). 
In 2015, after evaluating information on chemical uses,

[[Page 85540]]

properties, occurrences, releases to the environment and regulatory 
restrictions, the 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 the EPA's 2000 Human Health Methodology.95 96 
For these pollutants, the EPA proposes to use the same RSCs to derive 
the HHC. For pollutants where the EPA did not update the 304(a) HHC in 
2015, the EPA proposes to use an RSC of 0.2 to derive HHC following the 
Exposure Decision Tree approach described in the EPA's 2000 
Methodology; this approach takes into consideration potential 
significant exposure sources to Floridians other than drinking water 
and inland and nearshore fish and shellfish and results in the most 
health protective HHC. In the case of antimony (for which the EPA did 
not update the 304(a) recommended HHC in 2015), EPA proposes to use an 
RSC of 0.4 consistent with the RSC value used the last time the agency 
updated this criterion.\97\
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    \95\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. EPA-822-B-00-
004. https://www.epa.gov/sites/default/files/2018-10/documents/methodology-wqc-protection-hh-2000.pdf.
    \96\ USEPA, 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. https://www.epa.gov/wqc/human-health-water-quality-criteria.
    \97\ USEPA. (2002). National Recommended Water Quality Criteria: 
2002 Human Health Criteria Calculation Matrix. EPA-822-R-02-012. 
https://water.epa.gov/scitech/swguidance/standards/upload/2002_12_30_criteria_wqctable_hh_calc_matrix.pdf.
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7. Pollutant-Specific Bioaccumulation Factors
    Where data are available, the 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. For the 
2015 recommended 304(a) HHC update, the EPA estimated chemical-specific 
BAFs for three different trophic levels of fish (levels 2 through 4), 
using a framework for deriving national BAFs described in EPA's 2000 
Methodology.\98\ The EPA proposes to use those BAFs to calculate the 
proposed HHC. Where BAFs are not available at this time for certain 
pollutants, the EPA proposes to use the bioconcentration factors (BCFs) 
that the EPA used the last time it updated its CWA section 304(a) 
recommended criteria for those pollutants as the best available 
scientific information. The EPA specifically invites comment on whether 
there are any robust, publicly available state-specific BAF data that 
the EPA should consider. See Table 1 of this preamble, columns B4 
through B7 for a list of EPA's proposed bioaccumulation factors by 
pollutant. As noted above, if the resulting draft HHC values are less 
stringent than Florida's existing HHC, those values are noted with an 
asterisk in Table 1 of this preamble and are excluded from the EPA's 
proposed HHC.
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    \98\ USEPA. (2000). Methodology for Deriving Ambient Water 
Quality Criteria for the Protection of Human Health. 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 mentioned above, the EPA no longer has 304(a) recommended HHC 
for beryllium after having withdrawn its 1980 beryllium 304(a) 
recommendations.\99\ However, the EPA is not aware of any science-based 
BAFs or even more recent BCFs to suggest that the BCF of 19 from the 
EPA's 1980 304(a) recommended criteria \100\ is not the best available 
scientific information for beryllium. A 1968 study by Chapman et al. 
reports a BCF of 100 for fish, but this study pre-dates the EPA's 1980 
criteria document.\101\ Additionally, the Agency for Toxic Substances 
and Disease Registry's January 2022 draft Toxicological Profile for 
Beryllium notes that beryllium does not bioconcentrate in aquatic 
organisms, and that the agency did not find evidence of beryllium 
bioaccumulation in the food chain of humans.\102\ Therefore, the EPA 
calculated draft HHC for beryllium using the BCF of 19 from the EPA's 
withdrawn 1980 304(a) recommended beryllium criteria document. This is 
consistent with the approach that Florida was proposing to follow in 
2016.\103\ When using this BCF for beryllium, in conjunction with the 
other inputs described above, the resulting draft HHC are less 
stringent than Florida's existing HHC for beryllium. Therefore, as 
noted above consistent with CWA section 510, the EPA is not proposing 
Federal HHC for beryllium in this rulemaking.
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    \99\ USEPA. (October 1980). Ambient Water Quality Criteria for 
Beryllium. EPA 440 5-80-024.
    \100\ Id.
    \101\ Chapman, W.H., Fisher, H.L. & Pratt, M.W. (1968). 
Concentration factors of chemical elements in edible aquatic 
organisms. Lawrence Radiation Laboratory.; Shigematsu et al. 
Spectrophotometric Determination of Beryllium in biomaterials and 
Natural Water. Eunseki Kagaku.
    \102\ ATSDR. (January 2022). Toxicological Profile for 
Beryllium. https://www.atsdr.cdc.gov/ToxProfiles/tp4.pdf.
    \103\ Florida Department of Environmental Protection. (2016). 
Technical Support Document: Derivation of Human Health-Based 
Criteria and Risk Impact Statement. https://floridadep.gov/sites/default/files/HH_TSD.pdf.
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D. Proposed Human Health Criteria for Florida

    The EPA proposes new HHC for 37 priority toxic pollutants and 
revised HHC for 36 priority toxic pollutants to protect the designated 
uses of Florida's waters (see Table 1 of this preamble).\104\ The 
criteria in columns C1 and C2 of Table 1 of this preamble apply to 
state waters where the Seminole Tribe and Miccosukee Tribe do not have 
reserved rights to fish on a subsistence basis. The criteria in columns 
D1 and D2 of Table 1 of this preamble apply to state waters where the 
Seminole Tribe and Miccosukee Tribe have reserved rights to fish on a 
subsistence basis. The water-plus-organism criteria in either column C1 
or D1 of Table 1 of this preamble are the applicable criteria for any 
waters that include the Class I use (potable water supplies) defined in 
Florida's WQS (Chapter 62-302, Florida Administrative Code). The 
organism-only criteria in either column C2 or D2 of Table 1 of this 
preamble are the applicable criteria for any waters that do not include 
the Class I use and that are defined at Chapter 62-302 of the Florida 
Administrative Code as the following:

    \104\ Table 1 of this preamble includes the 77 pollutants that 
EPA identified in its December 2022 Administrator's Determination as 
needing new or revised HHC. As explained further above (see Section 
IV.A. of this preamble), when EPA calculated the new and revised HHC 
for those 77 pollutants using a sound scientific rationale, 
including a revised FCR of either 22 g/day or 142 g/day, the 
resulting draft criteria that the agency found would be protective 
of the State's designated uses were in some cases less stringent 
than Florida's existing HHC. For four pollutants--1,1-
Dichloroethylene, Beryllium, Chrysene and Phenol--all four of the 
associated HHC were less stringent than Florida's existing HHC. EPA 
has included those pollutants in Table 1 here for clarity and 
transparency on the approach that the EPA followed, but not in the 
proposed regulatory text where the agency is not proposing any HHC 
associated with those pollutants.

--Class II--Shellfish Propagation or Harvesting;
--Class III--Fish Consumption; Recreation, Propagation and Maintenance 
of a Healthy, Well-Balanced Population of Fish and Wildlife; or
--Class III--Limited--Fish Consumption; Recreation or Limited 
Recreation; and/or Propagation and Limited Maintenance of a Limited 
Population of Fish and Wildlife.

    The EPA solicits comment on the criteria and the inputs the EPA 
used to derive these criteria.
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E. Applicability

    Under the CWA, Congress gave states primary responsibility for 
developing and adopting WQS for their navigable waters (CWA section 
303(a) through (c)). Although the EPA is proposing revised HHC for 
Florida, Florida continues to have the option to adopt and submit to 
the EPA revised HHC for the state's waters consistent with CWA section 
303(c) and the EPA's implementing regulations at 40 CFR part 131. 
Consistent with CWA section 303(c)(4), if Florida adopts and submits 
revised HHC and the EPA approves such criteria before finalizing this 
proposed rulemaking, the EPA would not proceed with the final rule for 
those waters and/or pollutants for which the EPA approves Florida's 
criteria.
    If the EPA finalizes this proposed rulemaking, and Florida 
subsequently adopts and submits new HHC, the EPA's federally 
promulgated criteria will remain applicable for purposes of the CWA 
until the EPA withdraws the federally promulgated criteria. The EPA 
would undertake such a rulemaking to withdraw the Federal criteria for 
those waters and/or pollutants if and when Florida adopts and the EPA 
approves corresponding criteria that meet the requirements of section 
303(c) of the CWA and EPA's implementing regulations at 40 CFR part 
131.

F. Alternative Regulatory Approaches and Implementation Mechanisms

    The Federal WQS regulation at 40 CFR part 131 provides several 
approaches that Florida may utilize, at its discretion, when 
implementing or deciding how to implement the final HHC resulting from 
this proposed rulemaking. Among other things, the EPA's WQS regulation: 
(1) 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); (2) specifies the requirements for adopting 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 designated 
use and criterion for a period of time (40 CFR 131.14); and (4) 
specifies how states and authorized Tribes adopt, revise, or remove 
designated uses (40 CFR 131.10). Each of these approaches is discussed 
in more detail in the next sections.
1. NPDES Permit Compliance Schedules
    The EPA's regulations at 40 CFR 122.47 and 131.15 address how 
permitting authorities can use schedules for compliance if the 
discharger needs additional time to undertake actions like facility 
upgrades or operation changes that will lead to compliance with the 
WQBEL based on the applicable WQS. The EPA's regulation at 40 CFR 
122.47 allows a permitting authority to include a compliance schedule 
in the NPDES permit, when appropriate as long as it requires compliance 
with the WQBEL as soon as possible and any schedule longer than 1 year 
includes interim requirements and the dates for their achievement. The 
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 the EPA's approval under 
CWA section 303(c) to ensure that a decision to allow a permit 
compliance schedule is transparent and allows for public input.\105\ 
Consistent with 40 CFR 131.15, Florida is authorized to grant permit 
compliance schedules to meet WQBELs based on the Federal HHC in 
Florida, if such permit compliance schedules are consistent with 40 CFR 
122.47.
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    \105\ 80 FR 51022 (August 21, 2015).
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2. Site-Specific Criteria
    The regulation at 40 CFR 131.11 specifies requirements for 
modifying water quality criteria to reflect site-specific conditions. 
In the context of this rulemaking, a site-specific criterion (SSC) is 
an alternative value to the Federal HHC that would be applied on an 
area-wide or water body-specific basis that meets the regulatory 
standard of protecting the designated uses, being based on sound 
science, and ensuring the protection and maintenance of downstream WQS. 
A SSC may be more or less stringent than the otherwise applicable 
Federal criterion. A SSC may be called for when further scientific data 
and analyses indicate that a different criterion may be needed to 
protect the human health designated uses in a particular water body or 
portion of a water body.
3. WQS Variances
    Florida could adopt and submit for the EPA's approval WQS 
variances, consistent with 40 CFR 131.14, to aid in implementation of 
the Federal HHC once promulgated. 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) but may be attainable in the future. These factors 
include where complying with NPDES permit limits more stringent than 
technology-based effluent limits would result in substantial and 
widespread economic and social impact. When adopting a WQS variance, 
states and authorized Tribes specify the interim requirements by 
identifying a quantifiable expression that reflects the highest 
attainable condition (HAC) during the term of the WQS variance, 
establishing the term of the WQS variance, and justifying the term by 
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. 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, thus allowing 
dischargers to make incremental water quality improvements. If 
dischargers are still unable to meet the WQBELs derived from the 
applicable designated use and criterion 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.
4. Designated Uses
    The EPA's proposed HHC apply to waters that Florida has designated 
for the following:
    [cir] Class I--Potable Water Supplies;
    [cir] Class II--Shellfish Propagation or Harvesting;
    [cir] Class III--Fish Consumption; Recreation, Propagation and 
Maintenance of a Healthy, Well-Balanced Population of Fish and 
Wildlife; or
    [cir] Class III--Limited--Fish Consumption; Recreation or Limited 
Recreation; and/or Propagation and Limited Maintenance of a Limited 
Population of Fish and Wildlife.
    The Federal regulation at 40 CFR 131.10 provides requirements for 
adopting, revising, and removing

[[Page 85545]]

designated uses related to HHC when attaining the use is not feasible 
based on one of the six factors specified in the regulation. If Florida 
removes the human health-related designated use to which the EPA is 
proposing this HHC to apply for any waters, the state must adopt the 
highest attainable human health-related use \106\ and criteria to 
protect the newly designated highest attainable use for those waters 
consistent with 40 CFR 131.11. It is possible that criteria other than 
the federally promulgated criteria would protect the highest attainable 
use. If the EPA were to find Florida's designated use revision to be 
consistent with CWA section 303(c) and the implementing regulation at 
40 CFR part 131, the agency would approve the revised WQS. The HHC 
promulgated here, once finalized, would not apply to those waters to 
which the human health-related use no longer applies upon the EPA's 
approval.
---------------------------------------------------------------------------

    \106\ 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)).
---------------------------------------------------------------------------

V. Economic Analysis

    The EPA focused its economic analysis on the potential cost impacts 
to current holders of individual NPDES permits and costs the state of 
Florida may bear to further assess waters identified as having 
exceedances and to develop Total Maximum Daily Loads (TMDLs) for waters 
newly identified as impaired under CWA section 303(d) using the 
proposed WQS. In its analysis of point sources, the EPA did not include 
facilities with individual permits for concentrated animal feeding 
operations or stormwater discharges or facilities covered under general 
permits. These permits typically focus on best management practices and 
relevant data for such facilities are limited. Costs might arise to 
facilities covered under these permits should the state modify the 
permits as a result of the final WQS. In addition, costs might arise to 
sectors with operations that include nonpoint sources of pollutants 
through implementation of TMDLs or through other voluntary, 
incentivized, or state-imposed controls. The proposed rulemaking does 
not directly regulate nonpoint sources, and under the CWA states are 
responsible for the regulation of nonpoint sources. The EPA recognizes 
that controls for nonpoint sources may be part of future TMDLs, but 
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.

A. Identifying Affected Entities

    Any HHC finalized as a result of this proposed rulemaking may serve 
as a basis for development of NPDES permit limits. Florida has NPDES 
permitting authority and retains considerable discretion in 
implementing WQS. The EPA evaluated the potential costs to NPDES 
dischargers associated with state implementation of the EPA's proposed 
HHC. This analysis is documented in ``Economic Analysis for Water 
Quality Standards Applicable to the State of Florida'' (Economic 
Analysis), which can be found in the record for this rulemaking. Any 
NPDES permitted facility that discharges pollutants for which the 
proposed HHC are more stringent than Florida's current criteria (or for 
which Florida has no currently applicable criteria) could potentially 
incur compliance costs. The types of affected facilities include 
sewerage systems and industrial facilities discharging wastewater to 
surface waters (i.e., point sources).
    The EPA identified 376 point source facilities that could be 
affected by this proposed rulemaking. Of these potentially affected 
facilities, 171 are major dischargers and 205 are minor dischargers. As 
noted, the EPA did not include concentrated animal feeding operations 
with individual permits, stormwater discharges with individual permits, 
or facilities covered under general permits in its analysis because of 
limited data for such facilities and permit requirements that typically 
focus on best management practices.
    Of the potentially affected facilities, the EPA evaluated a sample 
of 78 major facilities (38 wastewater treatment facilities categorized 
under Standard Industrial Classification (SIC) Code 4952 and 40 
facilities categorized under other SIC Codes). Most facilities 
categorized under SIC Code 4952 are publicly owned treatment works 
(POTWs), but some are privately owned. Minor facilities are less likely 
to monitor for proposed HHC parameters and 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. The EPA did not evaluate minor facilities for this analysis. 
Table 2 of this preamble summarizes these potentially affected 
facilities by type and category.

                Table 2--Potentially Affected Facilities
------------------------------------------------------------------------
             Category                 Minor        Major         All
------------------------------------------------------------------------
Sewerage Systems (SIC Code 4952).           76           92          168
Industrial (Other SIC Codes).....          129           79          208
                                  --------------------------------------
    Total........................          205          171          376
------------------------------------------------------------------------

B. Method for Estimating Costs

    The EPA selected a certainty sample consisting of the 6 facilities 
in SIC Code 4952 (Sewerage Systems) with design flows greater than 50 
million gallons per day (mgd) and the industrial facility with the 
largest reported flow (which was in SIC Code 4911--Electric Services) 
to capture the facilities with the potential for the largest costs. The 
EPA evaluated a stratified random sample of the remaining major 
facilities. For facilities in SIC Code 4952, EPA grouped facilities by 
design flow range and took a random sample of facilities from each 
group. The EPA grouped industrial facilities by SIC Code and took a 
random sample of industrial facilities by SIC Code grouping. For all 
sample facilities, the EPA evaluated existing baseline permit 
conditions, assessed whether the discharge would cause, have the 
reasonable potential to cause, or contribute to an exceedance of

[[Page 85546]]

the proposed HHC, and evaluated the potential to exceed projected 
effluent limitations derived from the proposed HHC based on the last 
five years of effluent monitoring data (if available). Only the costs 
of compliance actions above the level of controls needed to comply with 
existing Florida criteria are attributable to the proposed rulemaking.
    The EPA assumed that dischargers would pursue the least cost means 
of compliance with WQBELs derived from the proposed HHC. Compliance 
actions attributable to the proposed rulemaking may include one-time 
costs (e.g., conducting a mixing zone study, completing a treatment 
optimization study) or annualized costs (e.g., treatment modification, 
additional treatment). To determine annual costs for a specific 
facility, the EPA annualized capital costs over 20 years using discount 
rates of 3 percent and 7 percent and added incremental operation and 
maintenance costs to obtain total annual costs. To obtain an estimate 
of total costs to point sources, the EPA extrapolated both the one-time 
and annualized costs for the random sample based on the flow volume for 
the sample facilities in a facility group and the flow volume for 
facilities outside the sample for that facility group.
    The EPA also evaluated potential administrative costs to the state 
for additional water body assessment and for developing additional 
TMDLs under CWA section 303(d) for waters that may be newly identified 
as impaired as a result of the proposed HHC. Using available ambient 
monitoring data, the EPA compared pollutant concentrations to existing 
Florida criteria and the proposed HHC, identifying waterbodies that may 
be incrementally impaired (i.e., impaired under the proposed HHC but 
not under the existing Florida criteria). An exceedance of a criterion 
is sufficient to place an assessment unit (Waterbody Identification 
Number or WBID) on Florida's Planning List and allows Florida DEP to 
collect additional data and information to evaluate whether the water 
is impaired and a TMDL is needed for the WBID. The EPA considered any 
exceedance of the proposed HHC that did not also exceed Florida's 
current criteria a new exceedance. If the annual average concentration 
for a pollutant in a WBID exceeds the corresponding HHC, that WBID is 
placed on Florida's Impaired Waters Rule (IWR) Verified List and would 
require developing a TMDL. To calculate an annual average there must be 
a minimum of three samples in the year collected over a minimum of 
three quarters of the year. If these data requirements are not met, an 
annual average is not calculated.

C. Results

    Based on the results for the 78 sample facilities across SIC Code 
4952 and 11 industrial SIC code categories, the EPA estimated a range 
of total one-time and total annual costs to point sources as shown in 
Table 3.

                          Table 3--Estimated One-Time and Annual Costs to Point Sources
                                                 [2022 Dollars]
----------------------------------------------------------------------------------------------------------------
              Total estimated one-time cost                  Total estimated annual cost (20 years, 3 percent
---------------------------------------------------------                     discount rate)
                                                         -------------------------------------------------------
            Low                          High                         Low                        High
----------------------------------------------------------------------------------------------------------------
              $622,000                   $1,390,000                          $0                  $5,990,000
----------------------------------------------------------------------------------------------------------------

    The low end of the one-time cost range reflects an assumption that 
most facilities potentially impacted would be able to comply with 
revised effluent limitations or would conduct a mixing zone study and 
request a revised mixing zone in order to achieve compliance. The high 
end of the one-time cost range assumes that these facilities would 
conduct a study to determine how to optimize or modify existing 
treatment. For example, the estimated costs for most facilities in SIC 
Code 4952 are attributable to chlorodibromomethane, a disinfection 
byproduct. A potential one-time cost for these facilities would be a 
study to determine how to optimize existing chlorine disinfection 
processes or assess the feasibility of using an alternative 
disinfectant.
    The low end of the annual cost range reflects an assumption that 
one-time actions (e.g., mixing zone studies, process optimization) 
result in compliance with revised effluent limitations. The high end of 
the annual cost range assumes that facilities incur capital and 
operation and maintenance costs associated with installing and 
operating new or additional treatment. For example, for 
chlorodibromomethane the high end of the annual cost range assumes that 
some facilities replace chlorine disinfection with ultraviolet (UV) 
disinfection in order to comply with revised WQBELs derived from the 
proposed HHC.
    The EPA identified 65 instances of new exceedances in WBIDs under 
the proposed HHC, which would place the WBIDs and pollutants on 
Florida's Planning List. Of these 65 exceedances, an assessment of 
available annual average data indicated 45 potential incremental 
impairments, which could place these WBIDs and pollutants on Florida's 
IWR Verified List. To determine whether the remaining 20 WBIDs and 
pollutants would be placed on the IWR Verified List, Florida DEP staff 
would need to collect three additional samples from at least three 
different quarters of the same year. The EPA estimated the total costs 
associated with this determination, which include the cost of staff 
time to collect the samples, costs associated with travel (e.g., 
gasoline), the cost of shipping the samples to the Florida DEP's Bureau 
of Laboratories for analysis, and the cost of the laboratory analysis. 
The EPA also estimated a range for the total cost to develop TMDLs for 
the 45 WBIDs and pollutants potentially placed on Florida's IWR 
Verified List. These costs were based on single-cause single-waterbody 
TMDL development costs. Actual costs may be lower if the state develops 
multi-cause or multi-waterbody TMDLs. Table 4 of this preamble 
summarizes the administrative costs associated with additional 
assessment of waters on Florida's Planning List and TMDL development 
for waters potentially placed on the IWR Verified List.

[[Page 85547]]



                     Table 4--Estimated Total Costs Associated With Incremental Impairments
                                                 [2022 Dollars]
----------------------------------------------------------------------------------------------------------------
    Total additional assessment costs for WBIDs and      Total TMDL development costs for incrementally impaired
              pollutants on planning list                                         WBIDs
----------------------------------------------------------------------------------------------------------------
                                       $28,100                                       $1.99-2.14 million
----------------------------------------------------------------------------------------------------------------

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 14094: Modernizing Regulatory Review

    This action is not a significant regulatory action as defined in 
Executive Order 12866, as amended by Executive Order 14094, and was 
therefore not subject to a requirement for Executive Order 12866 
review.

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 action 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 Florida's considerable discretion in implementing these 
WQS, nor would it preclude Florida from adopting WQS that the 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 the EPA 
policy to promote communications between the EPA and state and local 
governments, the 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 Florida because the numeric 
criteria for Florida will apply to waters adjacent to Tribal waters and 
to waters where Tribes have reserved rights to fish for subsistence.
    The EPA consulted with Tribal governments under the EPA Policy on 
Consultation and Coordination with Indian Tribes early in the process 
of developing this regulation to ensure meaningful and timely input 
into its development. In March and May 2023, the EPA held consultation 
and coordination meetings with Tribal environmental staff and 
leadership to share information, hear their views and answer questions 
on the rulemaking.
    A Summary of Consultation, Coordination and Outreach with Federally 
Recognized Tribes on EPA's Proposed Water Quality Standards to Protect 
Human Health in Florida is available in the docket for this proposed 
rulemaking.

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

    Executive Order 13045 directs Federal agencies to include an 
evaluation of the health and safety effects of the planned regulation 
on children in Federal health and safety standards and explain why the 
regulation is preferable to potentially effective and reasonably 
feasible alternatives. This action is not subject to Executive Order 
13045 because it is not a significant regulatory action under section 
3(f)(1) of Executive Order 12866, and because the EPA does not believe 
the environmental health or safety risks addressed by this action 
present a disproportionate risk to children. As noted in Section III.B 
of this preamble, the 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. The EPA's proposed HHC for Florida are similarly based on 
reducing the chronic health effects occurring 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 and 
Executive Order 14096: Revitalizing our Nation's Commitment to 
Environmental Justice for All

    The EPA believes that the human health or environmental conditions 
that exist prior to this action result in or have the potential to 
result in disproportionate and adverse human health or environmental 
effects on communities with environmental justice concerns. Florida's 
current FCR of 6.5 g/day is far lower than national, regional or state-
specific studies suggest Floridians consume. In addition, Florida does 
not have HHC for certain priority toxic pollutants that are likely to 
be present in Florida's waters. As a result, Florida's HHC are not 
protective of Florida's designated uses. Many groups in Florida, such 
as subsistence and recreational Tribal and non-Tribal fishers, consume 
self-caught fish and

[[Page 85548]]

shellfish. Florida's current HHC expose these higher fish consumers to 
greater risk from toxic pollutants. Florida's low FCR and lack of HHC 
for additional priority toxic pollutants potentially present in the 
state's waters disproportionately affect these groups.
    The EPA believes that this action is likely to reduce existing 
disproportionate and adverse effects on communities with environmental 
justice concerns. Specifically, this rule would establish HHC based on 
a FCR of 142 g/day in areas where Tribes have reserved rights to fish 
for subsistence, which would help protect higher fish consumers, and it 
would increase the statewide FCR to 22 g/day in areas where Tribes do 
not have reserved rights to fish for subsistence, which would help 
protect the general population of fish consumers in the state. 
Additionally, it would establish new HHC for priority toxic pollutants 
for which there are currently no HHC. This will ensure that Florida's 
HHC protect all users of Florida's waters, including Tribes who engage 
in subsistence fishing where they have a reserved right to do so.
    To achieve the benefits associated with a final rule, the EPA 
recognizes that some facilities may need to add pollution control 
measures and incur additional compliance costs over time to meet any 
WQBELs needed to achieve the HHC. As discussed in Section V of this 
preamble, the EPA estimates that there are 376 point source facilities 
that could be affected by this proposed rulemaking. Due to the large 
number of potentially affected facilities and the time intensive nature 
of ascertaining potential costs for each individual facility, the EPA 
did not perform a facility-by-facility analysis of potential 
environmental justice impacts and instead only costed for a sample of 
facilities. To assess generally whether compliance costs would 
overburden any regions of the state, the EPA mapped the 376 point 
source facilities (see the Economic Analysis in the docket for this 
rule for more information). In mapping the facilities, the EPA did not 
find that the facilities were concentrated in such a way that 
particular regions of the state were likely to be financially 
overburdened by the rulemaking. The potentially affected facilities are 
spread across the state, though they tend to be concentrated in more 
populated areas. However, in more populous areas, costs can be shared 
more broadly across the larger population size.
    In addition, the EPA analyzed the potential environmental justice 
impacts on some of those facilities in the sample for which it 
estimated potential costs, in order to better understand the range of 
potential impacts to affected communities. The EPA finds that there is 
a considerable range of potential impacts. Many facilities are 
estimated to have no potential new costs (see Section V of this 
preamble). Others sampled had relatively low costs per household. For 
illustration, the Howard F. Curren Advanced Wastewater Treatment Plant 
treats all wastewater discharged to Tampa's collection system from both 
Tampa and surrounding suburbs.\107\ Using EJScreen, the EPA examined 
income levels and the unemployment rate in the area served. Some areas 
showed low environmental justice concerns (not low income and low 
unemployment rate), whereas other areas in the county had slightly 
higher environmental justice concerns (low income and higher 
unemployment). The EPA estimates that the facility could potentially 
incur annual costs of up to $559,317 per year.\108\ The facility serves 
over 100,000 customers,\109\ which could result in a per-customer cost 
of $5.59 per year, if costs are distributed evenly across all 
customers. This potentially modest increase in the per customer 
sewerage bill is unlikely to disproportionally impact low-income 
populations and/or communities with high unemployment rates.
---------------------------------------------------------------------------

    \107\ Tampa Wastewater Department, Howard F. Curren Advanced 
Wastewater Treatment Plant, https://www.tampa.gov/wastewater/info/advanced-wastewater-treatment-plant?utm_source=direct&utm_medium=alias&utm_campaign=tampagovnet 
(last accessed July 17, 2023).
    \108\ See the Economic Analysis for Water Quality Standards to 
Protect Human Health in Florida in the docket for this rulemaking.
    \109\ Tampa Wastewater Department, About Us--Wastewater, https://www.tampa.gov/wastewater/about-us (last accessed July 17, 2023).
---------------------------------------------------------------------------

    On the other end, some facilities have higher projected per-
household costs. The City of Bonifay's Waste Water Treatment Facility 
is projected to have annual costs of $221,253. Bonifay has 1110 
households,\110\ resulting in annual per-household costs of $199.68 per 
year, assuming that all costs are passed onto residential customers. 
According to EJScreen, Bonifay ranks between the 70th and 100th 
percentile--depending on the area of the City--in terms of the 
percentage of the population that is low income.\111\ Significant 
portions of Bonifay rank high in terms of the percentage of the 
population experiencing unemployment, as well. Such large costs, then, 
have the potential to disproportionately affect low-income households 
or people experiencing unemployment. However, actual impacts depend on 
a number of factors, including how the state implements the new 
criteria, how costs are financed, and how costs are distributed among 
rate-payers. States have wide latitude in how they implement the 
criteria, including the authority to adopt variances for those 
facilities for which meeting the standards would cause substantial and 
widespread economic and social impact. Some communities could apply for 
grants for such upgrades or the state may share part of the cost 
burden. In addition, the Bipartisan Infrastructure Law included $50 
billion in funding for infrastructure improvements to the Nation's 
wastewater and drinking water systems. Moreover, some municipalities 
have customer assistance programs \112\ or could implement progressive 
rate structures that reduce the cost burden on low-income 
households.\113\ Finally, the costs of any such upgrades must be 
balanced against the potential benefits of having access to cleaner 
water. The EPA seeks comment on potential environmental justice impacts 
of the rulemaking.
---------------------------------------------------------------------------

    \110\ U.S. Census, Bonifay City, Florida, https://data.census.gov/profile?g=160XX00US1207450 (last accessed July 24, 
2023).
    \111\ USEPA, the EPA's Environmental Justice Screening and 
Mapping Tool (EJScreen), https://ejscreen.epa.gov/mapper/ (last 
accessed July 24, 2023).
    \112\ Florida Commerce, Find Your Local Low-Income Household 
Water Assistance Program Provider for Help, https://www.floridajobs.org/community-planning-and-development/community-services/low-income-household-water-assistance-program/find-your-local-low-income-household-water-assistance-program-provider-for-help (last accessed July 28, 2023).
    \113\ USEPA. (February 2023). Clean Water Act Financial 
Capability Assessment Guidance, https://www.epa.gov/system/files/documents/2023-01/cwa-financial-capability-assessment-guidance.pdf.
---------------------------------------------------------------------------

    To ensure that this rulemaking considers the interests and 
perspective of Tribes, the EPA engaged with Tribes that may be affected 
by this action to receive meaningful and timely input from Tribal 
officials. See Section VI.F of this preamble for a summary of Tribal 
consultation.
    In addition to Executive Orders 12898 and 13175, and in accordance 
with Title VI of the Civil Rights Act of 1964, each Federal agency 
shall ensure that all programs or activities receiving Federal 
financial assistance that affect human health or the environment do not 
directly, or through contractual or other arrangements, use criteria, 
methods, or practices that discriminate on the basis of race, color, or 
national origin. With that directive in mind, in August 2011 the 
Environmental Justice Interagency Working Group established a Title VI 
Committee to address the intersection of agencies' environmental 
justice efforts with their Title VI enforcement and

[[Page 85549]]

compliance responsibilities. If Florida 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, the EPA expects that Florida will consider 
disproportionately high adverse human health and environmental effects 
on communities with environmental justice concerns when implementing 
this rule under the CWA.
    The information supporting this Executive Order review is contained 
in the above preamble, the document titled Summary of Consultation, 
Coordination and Outreach with Federally Recognized Tribes on EPA's 
Proposed Water Quality Standards to Protect Human Health in Florida and 
the Economic Analysis for this rule. The latter two documents can be 
found in the docket for this action.

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


Sec.  131.36  [Amended]

0
2. Amend Sec.  131.36 by removing and reserving paragraph (d)(6).
0
3. Add Sec.  131.XX to read as follows:


Sec.  131.XX  Water quality standards to protect human health in 
Florida.

    (a) Scope. This section promulgates human health criteria for 
priority toxic pollutants in surface waters in Florida.
    (b) Criteria for priority toxic pollutants in Florida. The 
applicable human health criteria are shown in Table 1 to Paragraph (b).
BILLING CODE 6560-50-P

[[Page 85550]]

[GRAPHIC] [TIFF OMITTED] TP08DE23.036


[[Page 85551]]


[GRAPHIC] [TIFF OMITTED] TP08DE23.037


[[Page 85552]]


[GRAPHIC] [TIFF OMITTED] TP08DE23.038

    (c) Applicability. (1) The criteria in paragraph (b) of this 
section apply to waters with Florida's designated uses cited in 
paragraph (d) of this section and apply concurrently with other 
applicable water quality criteria.

[[Page 85553]]

    (2) The criteria established in this section are subject to 
Florida's general rules of applicability in the same way and to the 
same extent as are other federally promulgated and state-adopted 
numeric criteria when applied to the same use classifications in 
paragraph (d) of this section.
    (i) For all waters with mixing zone regulations or implementation 
procedures, the criteria apply at the appropriate locations within or 
at the boundary of the mixing zones; otherwise the criteria apply 
throughout the waterbody including at the end of any discharge pipe, 
conveyance or other discharge point within the waterbody.
    (ii) When determining critical low flows, the state must not use a 
low flow value below which numeric non-carcinogen and carcinogen human 
health criteria can be exceeded that is less stringent than the 
harmonic mean flow for waters suitable for the establishment of low 
flow return frequencies (i.e., streams and rivers). Harmonic mean flow 
is a long-term mean flow value calculated by dividing the number of 
daily flows analyzed by the sum of the reciprocals of those daily 
flows.
    (iii) If the state does not have such a low flow value for numeric 
criteria, then none will apply and the criteria in paragraph (b) of 
this section herein apply at all flows.
    (d) Applicable use designations. (1) All waters in Florida assigned 
to the following use classifications are subject to the criteria 
identified in paragraph (d)(2) of this section:
    (i) Class I--Potable Water Supplies;
    (ii) Class II--Shellfish Propagation or Harvesting;
    (iii) Class III--Fish Consumption; Recreation, Propagation and 
Maintenance of a Healthy, Well-Balanced Population of Fish and 
Wildlife; or
    (iv) Class III--Limited--Fish Consumption; Recreation or Limited 
Recreation; and/or Propagation and Limited Maintenance of a Limited 
Population of Fish and Wildlife.
    (2) The criteria in columns C1 and C2 of Table 1 in paragraph (b) 
of this section apply to Florida waters where the Seminole Tribe and 
Miccosukee Tribe do not have reserved rights to fish on a subsistence 
basis. Where these waters include the use classification of Class I--
Potable Water Supplies, the criteria in column C1 of Table 1 in 
paragraph (b) of this section apply. Where these waters do not include 
the use classification of Class I--Potable Water Supplies, the criteria 
in column C2 of Table 1 in paragraph (b) of this section apply.
    (3) The criteria in columns D1 and D2 of Table 1 in paragraph (b) 
of this section apply to Florida waters where the Seminole Tribe and 
Miccosukee Tribe have reserved rights to fish on a subsistence basis. 
Where these waters include the use classification of Class I--Potable 
Water Supplies, the criteria in column D1 of Table 1 in paragraph (b) 
of this section apply. Where these waters do not include the use 
classification of Class I--Potable Water Supplies, the criteria in 
column D2 of Table 1 in paragraph (b) of this section apply.

[FR Doc. 2023-26734 Filed 12-7-23; 8:45 am]
BILLING CODE 6560-50-C


