Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices 105041 

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. 

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: ow-docket@epa.gov. 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: 

Echols.Brandi@epa.gov. 

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/humanhealth-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 chemicalspecific 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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105042 Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices 

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., nonpotable 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 

PFAS 

Water + 

Organism 

HHC 

(ng/L) 

Organism 

Only 

HHC 

(ng/L) 

PFOA ........................ 0.0009 0.00036 

PFOS ........................ 0.06 0.07 

PFBS ........................ 400 500 


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Federal Register / Vol. 89, No. 247 / Thursday, December 26, 2024 / Notices 105043 

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] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OAR–2023–0129; FRL–12524– 

OMS–01] 

Agency Information Collection 

Activities; Submission to the Office of 

Management and Budget for Review 

and Approval; Comment Request; 

Consolidated Air Rule for the Synthetic 

Organic Chemical Manufacturing 

Industry (Renewal) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: The Environmental Protection 

Agency (EPA) has submitted an 

information collection request (ICR), 

Consolidated Air Rule for the Synthetic 

Organic Chemical Manufacturing 

Industry (EPA ICR Number 1854.14, 

OMB Control Number 2060–0443) to the 

Office of Management and Budget 

(OMB) for review and approval in 

accordance with the Paperwork 

Reduction Act. This is a proposed 

extension of the ICR, which is currently 

approved through December 31, 2024. 

Public comments were previously 

requested via the Federal Register on 

May 18, 2023 during a 60-day comment 

period. This notice allows for an 

additional 30 days for public comments. 

DATES: Comments may be submitted on 

or before January 27, 2025. 

ADDRESSES: Submit your comments, 

referencing Docket ID Number EPA– 

HQ–OAR–2023–0129, to EPA online 

using https://www.regulations.gov/ (our 

preferred method), by email to a-and-rdocket@epa.gov, or by mail to: EPA 

Docket Center, Environmental 

Protection Agency, Mail Code 28221T, 

1200 Pennsylvania Ave. NW, 

Washington, DC 20460. 

The EPA’s policy is that all comments 

received will be included in the public 

docket without change including any 

personal information provided, unless 

the comment includes profanity, threats, 

information claimed to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. 

Submit written comments and 

recommendations to OMB for the 

proposed information collection within 

30 days of publication of this notice to 

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

30-day Review—Open for Public 

Comments’’ or by using the search 

function. 

FOR FURTHER INFORMATION CONTACT: 

Muntasir Ali, Sector Policies and 

Program Division (D243–05), Office of 

Air Quality Planning and Standards, 

U.S. Environmental Protection Agency, 

Research Triangle Park, North Carolina 

27711; telephone number: (919) 541– 

0833; email address: ali.muntasir@

epa.gov. 

SUPPLEMENTARY INFORMATION: This is a 

request for approval of a new collection. 

An agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 

Supporting documents, which explain 

in detail the information that the EPA 

will be collecting, are available in the 

public docket for this ICR. The docket 

can be viewed online at https://

www.regulations.gov or in person at the 

EPA Docket Center, WJC West Building, 

Room 3334, 1301 Constitution Ave. NW, 

Washington, DC. The telephone number 

for the Docket Center is 202–566–1744. 

For additional information about EPA’s 

public docket, visit http://www.epa.gov/ 

dockets. 

Abstract: The Consolidated Federal 

Air Rule (CAR) for the Synthetic 

Organic Chemical Manufacturing 

Industry (SOCMI) (40 CFR part 65) was 

promulgated on December 14, 2000; and 

amended on August 27, 2007, November 

12, 2010, August 11, 2011, June 25, 

2013, and January 19, 2021. The CAR 

regulations are an optional compliance 

approach for new and existing SOCMI 

facilities that must comply with existing 

subparts in the Code of Federal 

Regulations (CFR). The CAR is a 

consolidation of major portions of 15 

different New Source Performance 

Standards (NSPS) and National 

Emission Standards for Hazardous Air 

Pollutants (NESHAP) pertaining to 

storage vessels, process vents, transfer 

racks, equipment leaks, and the general 

provisions for the three applicable parts 

(40 CFR parts 60, 61, and 63). These 

subparts are referred to as ‘‘referencing 

Subparts’’ because they have been 

amended to refer to the CAR as a 

compliance alternative. New facilities 

include those that commenced 

construction, modification or 

reconstruction after the date of proposal 

of the applicable referencing subpart(s). 

The referencing subparts include 40 

CFR part 60, subparts Ka, Kb, VV, VVa, 

DDD, III, NNN, and RRR; 40 CFR part 

61, subparts BB, Y, and V; 40 CFR part 

63, subparts F, G, H, and I. This ICR 

does not incorporate burden from 

recently proposed amendments to 

referencing subparts VV, VVa, III, NNN, 

RRR, F, G, H, or I (88 FR 25080) or 

subpart Kb (88 FR 68535). This 

information is being collected to assure 

compliance with 40 CFR part 65. 

Compliance with the CAR is a 

voluntary alternative. Sources may 

either continue to comply with existing 

applicable rules or may choose to 

comply with the consolidated rule. All 

existing sources must be in compliance 

with the requirements of the CAR and/ 

or its referencing Subparts within three 

years of the effective date (i.e., 

promulgation date) of the appropriate 

standard for the affected source. All new 

sources must be in compliance with the 

requirements of the CAR and/or its 

referencing Subparts upon startup or the 

promulgation date of standards for an 

affected source, whichever is later. 

In general, all the NSPS, NESHAP, 

CAR, and maximum achievable control 

technology (MACT) standards require 

initial notifications, performance tests, 

and periodic reports by the owners/ 

operators of the affected facilities. They 

are also required to maintain records of 

the occurrence and duration of any 

startup, shutdown, or malfunction in 

the operation of an affected facility or 

any period during which the monitoring 

system is inoperative. These 

notifications, reports, and records are 

essential in determining compliance, 

and are required of all affected facilities 

subject to these standards. 

Form Numbers: None. 

Respondents/affected entities: 

Synthetic organic chemical 

manufacturing facilities. 

Respondent’s obligation to respond: 

Mandatory (40 CFR part 60, subparts Ka, 

Kb, VV, VVa, DDD, III, NNN, and RRR; 

40 CFR part 61, subparts V, Y, and BB; 

and 40 CFR part 63, subparts F, G, H, 

and I; 40 CFR part 65). 


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