[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
------------------------------------------------------------------------
Examples of potentially
Category affected entities
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.'').
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.''
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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'').
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.'')
---------------------------------------------------------------------------
[[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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\53\ See 18 U.S.C. 1151 for definition of Indian Country.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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:
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
BILLING CODE 6560-50-P
[[Page 85541]]
[GRAPHIC] [TIFF OMITTED] TP08DE23.033
[[Page 85542]]
[GRAPHIC] [TIFF OMITTED] TP08DE23.034
[[Page 85543]]
[GRAPHIC] [TIFF OMITTED] TP08DE23.035
[[Page 85544]]
BILLING CODE 6560-50-C
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.
---------------------------------------------------------------------------
\105\ 80 FR 51022 (August 21, 2015).
---------------------------------------------------------------------------
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