[Federal Register Volume 89, Number 247 (Thursday, December 26, 2024)]
[Notices]
[Pages 105041-105043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30637]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OW-2024-0454; FRL 12023-01-OW]
Draft National Recommended Ambient Water Quality Criteria for the
Protection of Human Health for Perfluorooctanoic Acid, Perfluorooctane
Sulfonic Acid, and Perfluorobutane Sulfonic Acid
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of draft Clean Water Act (CWA) national recommended
ambient water quality criteria (AWQC) for the protection of human
health for three per- and polyfluoroalkyl substances (PFAS)--
perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS),
and perfluorobutane sulfonic acid (PFBS)--for a 60-day public comment
period. The EPA has developed these draft PFAS national recommended
human health criteria (HHC) to reflect the latest scientific
information, consistent with current EPA guidance, methods, and
longstanding practice. When PFAS national recommended HHC are
finalized, they will provide information that States and Tribes may
consider when adopting water quality standards.
DATES: Comments must be received on or before February 24, 2025.
ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OW-2024-0454, by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
Email: [email protected]. Include Docket ID No. EPA-HQ-OW-
2024-0454 in the subject line of the message.
Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Water Docket, Mail Code 28221T, 1200 Pennsylvania Avenue NW,
Washington, DC 20460.
Hand Delivery or Courier: 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. for this document. 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, see the ``Public Participation'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Brandi Echols, Office of Water, Health
and Ecological Criteria Division (4304T), Environmental Protection
Agency, 1301 Constitution Ave. NW, Washington, DC 20460; telephone
number: (202) 566-2717; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Public Participation
A. How can I get copies of these documents and other related
information?
The EPA has established Docket ID No. EPA-HQ-OW-2024-0454 for three
draft PFAS human health criteria: ``Draft Human Health Ambient Water
Quality Criteria: Perfluorooctanoic Acid (PFOA) and Related Salts;''
``Draft Human Health Ambient Water Quality Criteria: Perfluorooctane
Sulfonic Acid (PFOS) and Related Salts;'' and ``Draft Human Health
Ambient Water Quality Criteria: Perfluorobutane Sulfonic Acid (PFBS)
and Related Salts.'' Publicly available docket materials are available
either electronically through https://www.regulations.gov or in hard
copy at the EPA Docket Center, WJC West Building, Room 3334, 1301
Constitution Ave. 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). For further information on the EPA Docket Center
services and the current status, see: https://www.epa.gov/dockets.
The three draft human health criteria documents can be accessed on
the EPA's website through the following link: https://www.epa.gov/wqc/human-health-water-quality-criteria-pfas
B. Written Comments
Submit your comments, identified by Docket ID No. EPA-HQ-OW-2024-
0454, 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
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.
C. What should I consider as I prepare my comments for the EPA?
In preparation for submitting comments to the EPA on this action,
please review the draft chemical-specific criteria documents the EPA is
publishing in the public docket for this action under Docket ID No.
EPA-HQ-OW-2024-0454. Provide the EPA with comments regarding scientific
views related to the draft national recommended water quality criteria
for protecting human health. Include any recommended references for
data and other scientific information to be considered by the EPA. To
ensure that the EPA can properly respond to comments, commenters should
cite the section(s) or chemical(s) in the draft criteria documents to
which each comment refers. Commenters should use a separate paragraph
for each issue discussed and submit any references cited in their
comments. If you submit an electronic comment, the EPA recommends that
you include your name and other contact information in the body of your
comment. Electronic files should avoid any form of encryption and
should be free of any defects or viruses.
II. Background
A. What are PFAS and what are PFOA, PFOS, and PFBS?
Per- and polyfluoroalkyl substances (PFAS) are a large class of
thousands of synthetic chemicals that have been in use in the United
States and around the world since the 1940s. The ability for PFAS to
withstand heat and repel water and stains makes them useful in a wide
variety of consumer, commercial, and industrial products, and in the
manufacturing of other products and chemicals. Current scientific
research and available evidence have shown the potential for harmful
human health effects after being exposed to some PFAS, even at very low
levels. PFAS' persistence and resistance to hydrolysis,
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photolysis, metabolism, and microbial degradation raise additional
concerns about human exposure and health effects.
The EPA has developed draft recommended criteria for three PFAS:
perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS),
and perfluorobutane sulfonic acid (PFBS). In the United States, most
production of PFOA and PFOS, along with other long-chain PFAS, has been
phased out and generally replaced by production of other PFAS. PFOA and
its precursors have been used in flame repellents, cosmetics, paints,
polishes, and processing aids used in the manufacture of nonstick
coatings on cookware. PFOS has been used in a variety of products
including surface treatments for soil and stain resistance, coating of
paper, and in specialized applications such as firefighting foams. PFBS
has been used as a replacement chemical for PFOS. Prior to its use as a
PFOS replacement, PFBS had been produced as a byproduct and was present
in consumer products as an impurity. Environmental releases of PFBS may
result directly from the production and use of PFBS itself, production
and use of PFBS-related substances for various applications, and/or
from the degradation of PFBS precursors (i.e., substances that may form
PFBS during use, as a waste, or in the environment). Adverse human
health effects associated with exposure to PFOA or PFOS include but are
not limited to effects on the liver, growth and development (e.g., low
birth weight), the immune system (e.g., reduced response to vaccines),
lipid levels (e.g., high cholesterol), as well as increased risk of
certain types of cancer. Adverse human health effects associated with
exposure to PFBS include but are not limited to thyroid, developmental,
and kidney effects.
B. What are the EPA's national recommended ambient water quality
criteria for the protection of human health?
Section 304(a)(1) of the CWA requires the EPA to develop, publish,
and, from time to time, revise criteria for protection of water quality
and human health that accurately reflect the latest scientific
knowledge. HHC developed under CWA section 304(a) are based solely on
data and scientific judgments on the relationship between pollutant
concentrations and human health effects. CWA section 304(a) criteria do
not reflect consideration of economic impacts or the technological
feasibility of meeting pollutant concentrations in ambient water. HHC
are scientifically derived numeric concentrations of a pollutant that
are expected to protect human health from the adverse effects of that
pollutant in ambient water. HHC are designed to minimize the risk of
adverse effects occurring to humans from chronic (lifetime) exposure to
substances through drinking water and eating fish and shellfish from
inland and nearshore waters.
Under the CWA and its implementing regulations, States and
authorized Tribes are required to adopt water quality criteria to
protect designated uses (e.g., public water supply, recreational use,
or industrial use). The recommended HHC provide scientific information
to States and authorized Tribes when they establish water quality
standards that ultimately provide a basis for assessing water body
health and controlling discharges of pollutants. For each contaminant,
the EPA derives two recommended HHC: one criterion is based on the
consumption of both water and freshwater/estuarine fish and shellfish
(collectively referred to as ``organisms''), and the other is based on
the consumption of organisms alone. The applicability of one criterion
over the other depends on the designated use of a particular water body
or water bodies (e.g., public water supply vs. fishable waters). The
EPA recommends applying the organism-only HHC to a water body where the
designated use includes supporting fishable uses under section 101(a)
of the CWA but not a drinking water supply source (e.g., non-potable
estuarine waters that support fish or shellfish for human consumption).
The EPA's national recommended water quality criteria are not
regulations, and they do not substitute for the CWA or regulations. The
EPA's recommended criteria do not impose legally binding requirements.
States and authorized Tribes have the discretion to adopt, where
appropriate, other scientifically defensible water quality criteria
that differ from the EPA's CWA section 304(a) national recommendations.
III. Overview of EPA's Draft Human Health Criteria for PFOA, PFOS, and
PFBS
The EPA is publishing draft national recommended HHC for PFOA,
PFOS, and PFBS, based on the latest scientific knowledge and following
the EPA's longstanding, peer reviewed methodology for deriving human
health criteria. See Methodology for Deriving Ambient Water Quality
Criteria for the Protection of Human Health (2000), EPA-822-B-00-004,
October 2000. HHC are developed using a mathematical equation that
includes information on human health toxicity (non-cancer and cancer
effects), exposure factors (specifically, fish consumption rates, body
weight and drinking water intake), bioaccumulation potential, and
consideration of potentially significant exposure sources beyond
drinking water and freshwater/estuarine fish and shellfish consumption
(e.g., other foods, dust, consumer products; termed ``relative source
contribution'').
The EPA derived the draft HHC using the latest scientific
information regarding human health toxicity and potential exposures via
drinking water and eating fish and shellfish from inland and nearshore
waters. Specifically, the EPA derived the draft HHC using final EPA
toxicity values (reference doses, cancer slope factors) for each of the
three PFAS, which have undergone external peer review and public
comment. To account for human exposure to these three individual PFAS
from the fish and shellfish consumption pathway, the EPA developed
draft bioaccumulation factors for freshwater and estuarine fish and
shellfish, according to longstanding Agency methods. Consistent with
past practice, the EPA derived the draft HHC using 90th percentile per
capita rates for fish and shellfish consumption and drinking water
ingestion, and a mean body weight for adults, all based on national
survey data. The EPA derived a relative source contribution for each
PFAS to ensure that a person's total exposure to each chemical does not
exceed its noncancer toxicity value (reference dose).
The draft national recommended HHC for the three PFAS are
summarized in table 1. Each of the draft criteria documents
transparently describes the human health toxicity and exposure
information that the EPA used to derive the HHC. Each draft criteria
document also provides an illustrative example to assist States and
Tribes in the consideration of water quality standards for PFAS
mixtures.
Table 1--Draft Human Health Criteria (HHC) for PFOA, PFOS, and PFBS
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Water +
Organism Organism
PFAS HHC (ng/ Only HHC
L) (ng/L)
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PFOA.............................................. 0.0009 0.00036
PFOS.............................................. 0.06 0.07
PFBS.............................................. 400 500
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IV. The EPA's Request for Comments and Next Steps
The EPA will consider the comments received, revise the criteria
documents, and prepare final national recommended HHC for PFOA, PFOS,
and PFBS that reflect EPA's consideration of those comments. The EPA
will announce the availability of the final national recommended HHC
for these three PFAS in the Federal Register. When final, these HHC
will provide information that States and Tribes may consider when
adopting water quality standards for PFOA, PFOS, and PFBS. The EPA
expects to develop additional HHC for PFAS as scientific information
becomes available.
Bruno Pigott,
Principal Deputy Assistant Administrator.
[FR Doc. 2024-30637 Filed 12-23-24; 8:45 am]
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