National Primary Drinking Water Regulations; Announcement of the Results of EPA's Fourth Review of Existing Drinking Water Standards, 59623-59645 [2024-15807]
Download as PDF
59623
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
EPA-APPROVED VIRGINIA REGULATIONS AND STATUTES
State citation
State effective
date
Title/subject
*
*
Explanation
[former SIP citation]
EPA approval date
*
*
*
*
*
*
*
9 VAC 5, Chapter 20 General Provisions
*
*
*
*
*
Part II Air Quality Programs
*
5–20–204 .........
*
Nonattainment Areas ......
*
*
*
2/15/23
*
*
*
*
7/23/2024, [Insert Federal Register Citation].
*
*
*
*
*
*
List of nonattainment areas revised to include Giles
County locality for the primary sulfur dioxide
standard.
*
AGENCY:
July 23, 2024.
EPA is not accepting public
comment on the review results.
FOR FURTHER INFORMATION CONTACT:
Samuel Hernandez, Environmental
Protection Agency, Office of Ground
Water and Drinking Water, Standards
and Risk Management Division, (Mail
Code 4607M), 1200 Pennsylvania
Avenue NW, Washington, DC 20460;
telephone number: (202) 564–1735;
email address: hernandez.samuel@
epa.gov.
SUPPLEMENTARY INFORMATION:
Abbreviations and acronyms: The
following acronyms and abbreviations
are used throughout this document.
The Safe Drinking Water Act
(SDWA) requires the U.S.
Environmental Protection Agency (EPA
or the agency) to conduct a review every
six years of existing national primary
drinking water regulations (NPDWRs)
and determine which, if any, are
appropriate for revision. The purpose of
the review, called the Six-Year Review,
is to evaluate available information for
regulated contaminants to determine if
any new information on health effects,
treatment technologies, analytical
methods, occurrence, exposure,
implementation, and/or other factors
provides a basis to support a regulatory
revision that would improve or
strengthen public health protection.
While EPA has recently completed
several significant revisions to existing
regulations and other regulatory
revisions are currently underway, based
on this periodic review of all NPDWRs,
there are no additional candidates for
regulatory revision at this time.
2,4-D—2,4-Dichlorophenoxyacetic acid
ADWR—Aircraft Drinking Water Rule
BAT—Best Available Technology
CFR—Code of Federal Regulations
CVOC—Carcinogenic Volatile Organic
Contaminant
CWS—Community Water System
DBCP—1,2-Dibromo-3-Chloropropane
DBP—Disinfection Byproduct
DEHA—Di(2-ethylhexyl)adipate
DEHP—Di(2-ethylhexyl)phthalate
EPA—U.S. Environmental Protection Agency
EQL—Estimated Quantitation Level
FBRR—Filter Backwash Recycling Rule
GWR—Ground Water Rule
HAA5—Haloacetic Acids (five) (sum of
monochloroacetic acid, dichloroacetic
acid, trichloroacetic acid,
monobromoacetic acid, and dibromoacetic
acid)
ICR—Information Collection Request
IRIS—Integrated Risk Information System
LT2—Long-Term 2 Enhanced Surface Water
Treatment Rule
MCLG—Maximum Contaminant Level Goal
MCL—Maximum Contaminant Level
MDBP—Microbial and Disinfection
Byproduct
MDL—Method Detection Limit
MRDLG—Maximum Residual Disinfectant
Level Goal
DATES:
[FR Doc. 2024–16121 Filed 7–22–24; 8:45 am]
ADDRESSES:
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 141
[EPA–HQ–OW–2023–0572; FRL 7946–01–
OW]
National Primary Drinking Water
Regulations; Announcement of the
Results of EPA’s Fourth Review of
Existing Drinking Water Standards
Environmental Protection
Agency (EPA).
ACTION: Results of regulatory review.
SUMMARY:
ddrumheller on DSK120RN23PROD with RULES1
*
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
PO 00000
Frm 00033
Fmt 4700
Sfmt 4700
*
*
MRDL—Maximum Residual Disinfectant
Level
MRL—Minimum Reporting Level
NAS—National Academy of Sciences
NCWS—Non-Community Water System
NDWAC—National Drinking Water Advisory
Council
NPDWR—National Primary Drinking Water
Regulations
NRC—National Research Council
NTP—National Toxicology Program
PCBs—Polychlorinated biphenyls
PCE—Tetrachloroethylene
PQL—Practical Quantitation Limit
PT—Proficiency Testing
PWS—Public Water System
RfD—Reference Dose
RSC—Relative Source Contribution
RTCR—Revised Total Coliform Rule
SDWA—Safe Drinking Water Act
SDWIS—Safe Drinking Water Information
System
SWTR—Surface Water Treatment Rule
TCDD—Tetrachlorodibenzo-p-dioxin
TCE—Trichloroethylene
TCR—Total Coliform Rule
TNCWS—Transient Non-Community Water
System
TTHM—Total Trihalomethanes (sum of four
THMs: chloroform,
bromodichloromethane,
dibromochloromethane, and bromoform)
TT—Treatment Technique
USGS—U.S. Geological Survey
Table of Contents
I. General Information
A. Does this action apply to me?
B. How can I get copies of this document
and other related information?
II. Statutory Requirements for the Six-Year
Review
III. Regulations Included in the Six-Year
Review 4
IV. EPA’s Protocol for Reviewing the
NPDWRs Included in This Action
A. What was EPA’s review process?
B. How did EPA conduct the review of the
NPDWRs?
1. Initial Review
2. Health Effects
E:\FR\FM\23JYR1.SGM
23JYR1
59624
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
ddrumheller on DSK120RN23PROD with RULES1
3. Analytical Feasibility
4. Occurrence and Exposure Analysis
5. Treatment Feasibility
6. Risk-Balancing
7. Other NPDWR Revisions
V. Results of EPA’s Review of NPDWRs
A. Overview of Six-Year Review 4 Results
B. Chemical Phase Rules/Radionuclides
Rules
1. Key Review Outcomes
2. Summary of Review Results
3. Select NPDWRs with New Information
Not Appropriate for Revision
C. Microbial Contaminants Regulations
VI. References
regulation shall be promulgated in
accordance with this section, except
that each revision shall maintain, or
provide for greater, protection of the
health of persons.’’
Pursuant to the 1996 SDWA
Amendments, EPA completed and
published the results of its first Six-Year
Review (Six-Year Review 1) on July 18,
2003 (68 FR 42908, USEPA, 2003), the
second Six-Year Review (Six-Year
Review 2) on March 29, 2010 (75 FR
15500, USEPA, 2010a) and the third
Six-Year Review (Six-Year Review 3) on
January 11, 2017 (82 FR 3518, USEPA,
I. General Information
2017a).
A. Does this action apply to me?
During the Six-Year Review 1, EPA
This action itself does not impose any identified the Total Coliform Rule (TCR)
requirements on individual people or
as a candidate for revision.1 In Six-Year
entities. Instead, it notifies interested
Review 2, EPA identified four NPDWRs
corresponding to acrylamide,
parties of EPA’s review of existing
epichlorohydrin, tetrachloroethylene
national primary drinking water
(PCE), and trichloroethylene (TCE) as
regulations (NPDWRs) and its
candidates for revision. In Six-Year
conclusions about which of these
Review 3, eight NPDWRs were listed as
NPDWRs may warrant regulatory
candidates for revision, including:
revisions at this time. The Six-Year
Review is not a final regulatory decision chlorite, Cryptosporidium (under
SWTRs), Giardia lamblia, haloacetic
to revise or not revise an NPDWR, but
acids (HAA5), heterotrophic bacteria,
rather a planning process that involves
Legionella, total trihalomethanes
more detailed analyses of factors
(TTHM), and viruses (under SWTRs).
relevant to deciding whether a
rulemaking to revise an NPDWR should EPA also announced that the NPDWRs
for acrylamide and epichlorohydrin
be initiated.
were no longer candidates for revision
B. How can I get copies of this document due to low opportunity for further
and other related information?
reduction of public health risk through
1. Docket. EPA has established a
regulatory revision (82 FR 3525, USEPA,
docket for this action under Docket ID
2017a).
In this document, EPA is announcing
No. EPA–HQ–OW–2023–0572. Publicly
the results of the fourth Six-Year Review
available docket materials are available
(Six-Year Review 4). EPA’s
electronically on www.regulations.gov
announcement of whether to identify an
or in hard copy at the EPA Docket
Center, WJC West Building, Room 3334, NPDWR as a candidate for revision
(pursuant to SDWA section 1412(b)(9))
1301 Constitution Ave. NW,
is not a regulatory decision. Instead,
Washington, DC. The Docket Center’s
hours of operations are 8:30 a.m. to 4:30 announcing that an NPDWR is a
candidate for revision formally initiates
p.m., Monday through Friday (except
a regulatory process that involves more
Federal Holidays). For further
detailed analyses of health effects,
information on the EPA Docket Center
analytical constraints, treatment
services and the current status see:
feasibility, occurrence, benefits, costs,
https://www.epa.gov/dockets.
2. Electronic Access. You may access
and other policy considerations relevant
this Federal Register document
to informing an NPDWR revision effort.
electronically from https://www.federal
The Six-Year Review results do not
register.gov.
obligate the agency to revise an NPDWR
if EPA determines during the regulatory
II. Statutory Requirements for the Sixprocess that revisions are no longer
Year Review
appropriate and discontinues further
Under the Safe Drinking Water Act
(SDWA), as amended in 1996, EPA must
1 The NPDWRs apply to specific contaminants/
parameters or groups of contaminants. Historically,
periodically review existing NPDWRs
and, if appropriate, revise them. Section when issuing new or revised standards for these
contaminants/parameters, EPA has often grouped
1412(b)(9) of the SDWA states: ‘‘The
the standards together in more general regulations,
Administrator shall, not less often than
such as the Total Coliform Rule, the Surface Water
Treatment Rule or the Phase V rules. In this action,
every six years, review and revise, as
however, for clarity, EPA discusses the drinking
appropriate, each national primary
water standards as they apply to each specific
drinking water regulation promulgated
regulated contaminant/parameter (or group of
under this title. Any revision of a
contaminants), not the more general regulation in
which the contaminant/parameter was regulated.
national primary drinking water
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
efforts to revise the NPDWR. Similarly,
when EPA announces that a particular
NPDWR has not been identified as a
candidate for revision it means that the
agency has concluded that it is not
appropriate for revision at this time
based on available information.
The criteria that EPA has applied to
help identify when an NPDWR might be
considered as a ‘‘candidate for revision’’
are, at a minimum, that the regulatory
revision presents a meaningful
opportunity to improve the level of
public health protection, and/or achieve
cost savings while maintaining or
improving the level of public health
protection.
III. Regulations Included in the SixYear Review 4
Table 1 of this document lists all 94
NPDWRs established to date. The table
also reports the maximum contaminant
level goal (MCLG) and, where
applicable, the maximum contaminant
level (MCL). The MCLG is ‘‘set at the
level at which no known or anticipated
adverse effects on the health of persons
occur and which allows an adequate
margin of safety’’ (SDWA section
1412(b)(4)). The MCL for each
applicable NPDWR, is the maximum
permissible level of a contaminant in
water delivered to any user of a public
water system (PWS) and generally ‘‘is as
close to the maximum contaminant
level goal as is feasible’’ (SDWA section
1412(b)(4)(B)). If it is not ‘‘economically
or technically feasible to ascertain the
level of the contaminant,’’ EPA can
require the use of a treatment technique
(TT) in lieu of establishing an MCL. The
treatment technique(s) must prevent
known or anticipated adverse health
effects ‘‘to the extent feasible’’ (SDWA
section 1412(b)(7)(A)).2 In the case of
disinfectants (e.g., chlorine,
chloramines, chlorine dioxide), the
values reported in the table are not
MCLGs and MCLs, but maximum
residual disinfectant level goals
(MRDLGs) and maximum residual
disinfectant levels (MRDLs).
2 Under limited circumstances, SDWA section
1412(b)(6)(A) gives the Administrator the discretion
to promulgate an MCL or TT that is less stringent
than the most protective feasible standard that
‘‘maximizes health risk reduction benefits at a cost
that is justified by the benefits.’’ Similarly, SDWA
section 1412(b)(5) authorizes the Administrator to
promulgate an MCL or TT that is less stringent than
the most protective feasible standard if the more
protective standard would increase the level of
other contaminants in drinking water or interfere
with the efficacy of treatment techniques or process
used for compliance with other NPDWRs. Under
those circumstances, EPA is to promulgate feasible
a MCL or TT rule to ‘‘minimize the oversall risk of
adverse health effects’’ while avoiding an increase
in health risks from other contaminants.
E:\FR\FM\23JYR1.SGM
23JYR1
59625
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
As part of the fourth Six-Year Review,
EPA did not consider information after
December 2021, unless otherwise noted.
EPA identified 15 NPDWRs for which
there has either been a recently
completed, an ongoing, or a pending
regulatory action. EPA did not conduct
a detailed review of these 15 NPDWRs
for the Six-Year Review 4. These
include the ongoing Lead & Copper
rulemaking activities and the potential
revisions 3 of the Microbial and
Disinfection Byproduct Rules (MDBP).
The MDBP effort contemplates potential
regulatory revisions for the NPDWRs
covering the following contaminants:
(Bromate, Chloramines, Chlorine
Dioxide, Chlorine, Chlorite,
Cryptosporidium, Giardia lamblia,
Haloacetic acids, Heterotrophic bacteria,
Legionella, Total Trihalomethanes,
Turbidity, & Viruses).
The EPA did not include in this SixYear Review cycle the recently
promulgated per-and polyfluoroalkyl
substances (PFAS) regulations.4 The
PFAS regulations, promulgated in April
2024, established 6 new NPDWRs. The
EPA anticipates that once the PFAS
regulations go into effect and sufficient
information regarding compliance
monitoring becomes available, those
NPDWRs will be subject to a more
detailed regulatory review under a
future Six-Year Review cycle. This
document describes the detailed review
of the remaining 73 NPDWRs. section IV
of this document describes the Six-Year
Review 4 protocol, and section V of this
document describes the review results.
Please see USEPA (2024a) for more
details.
ddrumheller on DSK120RN23PROD with RULES1
TABLE 1—LIST OF NPDWRS
Contaminants/parameters
MCLG
(mg/L) 1 3
MCL or TT
(mg/L) 2 3
Contaminants/parameters
MCLG
(mg/L) 1 3
Acrylamide ...........................................
Alachlor ................................................
Alpha/photon emitters ..........................
Antimony ..............................................
Arsenic .................................................
Asbestos ..............................................
Atrazine ................................................
Barium .................................................
Benzene ...............................................
0 ...........................
0 ...........................
0 (pCi/L) ...............
0.006 ....................
0 ...........................
7 (million fibers/L)
0.003 ....................
2 ...........................
0 ...........................
TT .........................
0.002 ....................
15 (pCi/L) .............
0.006 ....................
0.010 ....................
7 (million fibers/L)
0.003 ....................
2 ...........................
0.005 ....................
0 ...........................
0.7 ........................
n/a 5 ......................
0 ...........................
0 ...........................
n/a ........................
0 ...........................
0.05 ......................
10 (ppt) .................
TT.
0.7.
0.060.
0.0004.
0.0002.
TT.
0.001.
0.05.
10 (ppt).
Benzo[a]pyrene ....................................
Beryllium ..............................................
Beta/photon emitters ...........................
Bromate ...............................................
Cadmium .............................................
Carbofuran ...........................................
Carbon tetrachloride ............................
Chloramines (as Cl2) ...........................
Chlordane ............................................
Chlorine (as Cl2) ..................................
Chlorine dioxide (as ClO2) ...................
0 ...........................
0.004 ....................
0 (millirems/yr) ......
0 ...........................
0.005 ....................
0.04 ......................
0 ...........................
4 ...........................
0 ...........................
4 ...........................
0.8 ........................
0.0002 ..................
0.004 ....................
4 (millirems/yr) ......
0.010 ....................
0.005 ....................
0.04 ......................
0.005 ....................
4.0 ........................
0.002 ....................
4.0 ........................
0.8 ........................
0 ...........................
0 ...........................
0.0002 ..................
0.002 ....................
0.04 ......................
0.1 ........................
10 .........................
1 ...........................
0.2 ........................
0 ...........................
10 (ppt) .................
TT.
TT.
0.0002.
0.002.
0.04.
0.1.
10.
1.
0.2.
0.001.
10 (ppt).
Chlorite ................................................
Chromium (total) ..................................
Copper .................................................
Cryptosporidium ...................................
0.8 ........................
0.1 ........................
1.3 ........................
0 ...........................
1.0
0.1
TT
TT
0.2 ........................
0.07 ......................
0.2 ........................
0.4 ........................
0 ...........................
0 ...........................
0.6 ........................
0.2 ........................
0.07 ......................
0.2 ........................
0.4 ........................
0.006 ....................
0.0002 ..................
0.6 ........................
10 (ppt) .................
0 (ppt) ...................
0 (ppt) ...................
Hazard Index 12 of
1.
0.5 ........................
0 ...........................
0 (pCi/L) ...............
0.05 ......................
0.004 ....................
0.1 ........................
0 ...........................
10 (ppt).
4.0 (ppt).
4.0 (ppt).
Hazard Index of 1.
Cyanide (as free cyanide) ...................
2,4-Dichlorophenoxyacetic acid (2,4-D)
Dalapon ...............................................
Di(2-ethylhexyl)adipate (DEHA) ..........
Di(2-ethylhexyl)phthalate (DEHP) .......
1,2-Dibromo-3- chloropropane (DBCP)
1,2-Dichlorobenzene (oDichlorobenzene).
1,4-Dichlorobenzene (pDichlorobenzene).
1,2-Dichloroethane (ethylene dichloride).
1,1-Dichloroethylene ............................
cis-1,2-Dichloroethylene ......................
trans-1,2-Dichloroethylene ...................
Dichloromethane (methylene chloride)
1,2-Dichloropropane ............................
Dinoseb ................................................
Diquat ..................................................
E. coli ...................................................
Endothall ..............................................
Endrin ..................................................
Epichlorohydrin ....................................
Ethylbenzene .......................................
Ethylene dibromide (EDB) ...................
Fluoride ................................................
Giardia lamblia 4 ..................................
Glyphosate ...........................................
Haloacetic acids (HAA5) .....................
Heptachlor ...........................................
Heptachlor epoxide ..............................
Heterotrophic bacteria 6 .......................
Hexachlorobenzene .............................
Hexachlorocyclopentadiene .................
Hexafluoropropylene oxide dimer acid
(HFPO–DA).
Lead .....................................................
Legionella ............................................
Lindane ................................................
Mercury (inorganic) ..............................
Methoxychlor .......................................
Monochlorobenzene (Chlorobenzene)
Nitrate (as N) .......................................
Nitrite (as N) ........................................
Oxamyl (Vydate) ..................................
Pentachlorophenol ...............................
Perfluorohexane sulfonic acid
(PFHxS).
Perfluorononanoic acid (PFNA) ...........
Perfluorooctane sulfonic acid (PFOS)
Perfluorooctanoic acid (PFOA) ............
PFAS Mixture (HFPO–DA, PFBS,
PFHxS, & PFNA).
Picloram ...............................................
Polychlorinated biphenyls (PCBs) .......
Radium 226/228 (combined) ...............
Selenium ..............................................
Simazine ..............................................
Styrene ................................................
2,3,7,8-TCDD (Dioxin) .........................
0.075 ....................
0.075 ....................
Tetrachloroethylene .............................
0 ...........................
0.005.
0 ...........................
0.005 ....................
Thallium ...............................................
0.0005 ..................
0.002.
0.007 ....................
0.07 ......................
0.1 ........................
0 ...........................
0 ...........................
0.007 ....................
0.02 ......................
0 ...........................
0.1 ........................
0.002 ....................
0 ...........................
0.7 ........................
0 ...........................
4.0 ........................
0.007 ....................
0.07 ......................
0.1 ........................
0.005 ....................
0.005 ....................
0.007 ....................
0.02 ......................
MCL,10 TT 8 11 ......
0.1 ........................
0.002 ....................
TT .........................
0.7 ........................
0.00005 ................
4.0 ........................
Toluene ................................................
Total coliforms 7 8 .................................
Total Trihalomethanes (TTHM) ...........
Toxaphene ...........................................
2,4,5-TP (Silvex) ..................................
1,2,4-Trichlorobenzene ........................
1,1,1-Trichloroethane ...........................
1,1,2-Trichloroethane ...........................
Trichloroethylene .................................
Turbidity 6 .............................................
Uranium ...............................................
Vinyl Chloride ......................................
Viruses .................................................
Xylenes (total) ......................................
1 ...........................
n/a ........................
n/a 9 ......................
0 ...........................
0.05 ......................
0.07 ......................
0.2 ........................
0.003 ....................
0 ...........................
n/a ........................
0 ...........................
0 ...........................
0 ...........................
10 .........................
1.
TT.
0.080.
0.003.
0.05.
0.07.
0.2.
0.005.
0.005.
TT.
0.030.
0.002.
TT.
10.
........................
........................
.........................
.........................
MCL or TT
(mg/L) 2 3
0.5.
0.0005.
5 (pCi/L).
0.05.
0.004.
0.1.
3 ×10 ¥8.
1 MCLG: the maximum level of a contaminant in drinking water at which no known or anticipated adverse effect on the health of persons would occur, allowing an
adequate margin of safety. Maximum contaminant level goals are nonenforceable health goals.
3 Additional information can be found at https://
www.epa.gov/system/files/documents/2022-04/
mdbp-rule-revisions-charge-to-the-ndwac.pdf.
4 On April 26, 2024, the EPA promulgated legally
enforceable drinking water standards to address
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
PFAS known to occur individually and as mixtures
in drinking water (89 FR 32532). The NPDWRs sets
limits for five individual PFAS: (perfluorooctanoic
acid (PFOA), perfluorooctane sulfonic acid (PFOS),
perfluorohexane sulfonic acid (PFHxS), perfluorono
nanoic acid (PFNA), hexafluoropropylene oxide
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
dimer acid (HFPO–DA, commonly known as GenX
Chemicals)); and also established a limit for
mixtures of any two or more of the following four
PFAS: (PFNA, PFHxS, perfluorobutane sulfonic
acid (PFBS), and HFPO–DA).
E:\FR\FM\23JYR1.SGM
23JYR1
59626
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
2 MCL: the maximum level allowed of a contaminant in water which is delivered to any user of a public water system. TT: any action, process, or procedure required of the water system that leads to the reduction of the level of a contaminant in tap water that reaches the consumer.
3 Units are in milligrams per liter (mg/L) unless otherwise noted. Milligrams per liter are equivalent to parts per million. For chlorine, chloramines, and chlorine dioxide, values presented are MRDLG and MRDL.
4 The current preferred taxonomic name is Giardia duodenalis, with Giardia lamblia and Giardia intestinalis as synonymous names. However, Giardia lamblia was
the name used to establish the MCLG in 1989. Elsewhere in this document, this pathogen will be referred to as Giardia spp. or simply Giardia unless discussing information on an individual species.
5 There is no MCLG for all five haloacetic acids. MCLGs for some of the individual contaminants are: dichloroacetic acid (zero), trichloroacetic acid (0.02 mg/L), and
monochloroacetic acid (0.07 mg/L). Bromoacetic acid and dibromoacetic acid are regulated with this group but have no MCLGs.
6 Includes indicators that are used in lieu of direct measurements (e.g., of heterotrophic bacteria, turbidity).
7 The Aircraft Drinking Water Rule (ADWR) 40 CFR part 141 subpart X, promulgated October 19, 2009, covers total coliforms and E. coli.
8 Under the RTCR, a PWS is required to conduct an assessment if it exceeded any of the TT triggers identified in 40 CFR 141.859(a). It is also required to correct
any sanitary defects found through the assessment. 40 CFR 141.859(c).
9 There is no MCLG for total trihalomethanes (TTHM). MCLGs for some of the individual contaminants are: bromodichloromethane (zero), bromoform (zero),
dibromochloromethane (0.06 mg/L), and chloroform (0.07 mg/L).
10 A PWS is in compliance with the E. coli MCL unless any of the conditions identified under 40 CFR 141.63(c) occur.
11 Under the GWR in 40 CFR 141.402, a ground water system that does not provide at least 4-log treatment of viruses and has a distribution system RTCR sample
that tests positive for total coliform is required to conduct triggered source water monitoring to evaluate whether the total coliform presence in the distribution system
is due to fecal contamination in the ground water source. The system must monitor for one of three State-specified fecal indicators (i.e., E. coli, coliphage, or
enterococci).
12 The Hazard Index is an approach that EPA uses to determine the health concerns associated with mixtures of certain PFAS in finished drinking water. The Hazard Index is made up of a sum of fractions. Each fraction compares the level of each PFAS measured in the water to the associated health-based water
concentration.
IV. EPA’s Protocol for Reviewing the
NPDWRs Included in This Action
ddrumheller on DSK120RN23PROD with RULES1
A. What was EPA’s review process?
This section provides an overview of
the process EPA used to review the
NPDWRs discussed in this document.
The protocol document, ‘‘EPA Protocol
for the Fourth Review of Existing
National Primary Drinking Water
Regulations,’’ contains a detailed
description of the process the agency
used to review the NPDWRs (USEPA,
2024c). The foundation of this protocol
was developed for the Six-Year Review
1 based on the recommendations of the
National Drinking Water Advisory
Council (NDWAC, 2000) and has
undergone minor clarifications during
each Six-Year Review cycle (USEPA,
2024c). Figure 1 presents an overview of
the Six-Year Review protocol and the
possible review outcomes.
The objective of the Six-Year Review
process is to identify and prioritize
NPDWRs for possible regulatory
revision. The two major outcomes of the
detailed review are either (1) the
NPDWR is not appropriate for revision
and no action is necessary at this time
or (2) the NPDWR is a candidate for
revision.
The reasons why EPA might list an
NPDWR as ‘‘not appropriate for revision
at this time’’ could include:
• Recently completed, ongoing, or
pending regulatory action: The NPDWR
was recently completed, is being
reviewed under an ongoing action, or is
subject to a pending action.
• Ongoing or planned health effects
assessment: The contaminant or
contaminants regulated by the NPDWR
has an ongoing or planned health effects
assessment.
• No new information: EPA did not
identify any new relevant information
for the contaminant since the last SixYear Review that indicates changes to
the NPDWR may be appropriate.
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
• Data gaps/emerging information:
New information indicates a possible
change to the MCLG and/or MCL but
changes to the NPDWR are not
appropriate due to data gaps and
emerging information that needs to be
evaluated.
• Low priority and/or no meaningful
opportunity: New information indicates
a possible change to the MCLG and/or
MCL but changes to the NPDWR are not
appropriate at this time due to one or
more of the following reasons: (1)
possible changes present negligible
gains in public health protection; (2)
possible changes present limited
opportunity for cost savings while
maintaining the same or greater level of
health protection; and/or (3) possible
changes are a low priority because of
competing workload priorities, limited
return on the administrative costs
associated with rulemaking, and the
burden on states and the regulated
community associated with
implementing any regulatory change
that would result.
Alternatively, the reasons why an
NPDWR could be listed as a candidate
for revision are that the regulatory
revision presents a meaningful
opportunity to improve the level of
public health protection, and/or achieve
cost savings while maintaining or
improving the level of public health
protection.
Individual regulatory provisions that
are evaluated as part of the Six-Year
Review process include: MCLG, MCL,
MRDLG, MRDL, TT, best available
technology (BAT), and other
requirements, such as monitoring
requirements.
For example, the microbial
regulations include TT requirements
because no reliable, affordable, and
technically feasible method is available
to measure the microbial contaminants
covered by those regulations. These TT
requirements rely on the use of
indicators that can be measured in
PO 00000
Frm 00036
Fmt 4700
Sfmt 4700
drinking water, such as detection of
total coliforms as an indicator of a
potential pathway for pathogenic
contamination in the distribution
system. As part of the Six-Year Review
4, EPA evaluated new information
related to the use of those indicators to
determine if a meaningful opportunity
to improve the level of public health
protection exists. Results of EPA’s
review of the microbial regulations are
presented in section V of this document.
Basic Principles
EPA applied several basic principles
to the Six-Year Review process:
• The agency sought to avoid
redundant review efforts. Because EPA
has reviewed information for certain
NPDWRs as part of recently completed,
ongoing, or pending regulatory actions,
these NPDWRs were not subject to
detailed review under the Six-Year
Review process.
• The agency does not believe it is
appropriate to consider revisions to
NPDWRs for contaminants with an
ongoing or planned health effect
assessment where the MCL is set equal
to the MCLG or that were set at the level
at which health risk reduction benefits
were maximized at a cost justified by
the benefits in accordance with SDWA
section 1412(b)(6)(A)). This principle
stems from the fact that any new health
effects assessment may affect the MCL
via a change in the MCLG or the
assessment of the benefits associated
with the MCL. EPA notes that these
NPDWRs are not appropriate for
revision and no action is necessary if
the health effects assessment would not
be completed during the review cycle.
• In evaluating the potential for new
information to affect NPDWRs, EPA
assumed no change to existing policies
and procedures for developing
NPDWRs. For example, in determining
whether new information affected the
feasibility of analytical methods for a
contaminant, the agency assumed no
E:\FR\FM\23JYR1.SGM
23JYR1
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
change to current policies and
procedures for calculating practical
quantitation limits.
• EPA may consider whether there is
new public health risk information to
justify accelerating review and potential
revision of a particular NPDWR before
the next review cycle.
Procedures
EPA also applied the following
procedures in the review process:
• EPA considered new information
from health effects assessments that
were completed by the information
cutoff date. Assessments completed
after this cutoff date will be reviewed by
EPA during the next review cycle.
• During the review, EPA identified
areas where relevant information, which
is needed to determine whether a
revision to an NPDWR may be
appropriate, was either: inadequate,
59627
unavailable (i.e., data gaps), or
emerging. To the extent EPA is able to
fill data gaps or fully evaluate the
emerging information, the agency will
consider the information as part of the
next review cycle.
• Finally, EPA assured that the
scientific analyses supporting the
review were consistent with the
agency’s peer review policy (USEPA,
2015a).
Figure 1: Six-Year Review Protocol Overview and Review Outcomes
NPDWRs Under Review
NPDWRs reviewed in recent or ongoing action?
Yes
No
Health effects assessment (HEA) in process or
planned?*
Yes
No
i;
New information to suggest possible changes (i.e.,
to an MCLG, MCL, Treatment Technique and/or
other re
tory revisions)?
!Uncertain- emerging
infomtation
Outcome:
No action
at this time
Yes
i
!___
No
Data sufficient to support regulatory revision?
No
Yes
Meaningful opportunity for health risk reduction
for persons served by PWSs and/or cost savings
while maintaining/improving public health
protection?
Outcome:
Candidate
for Revision
ddrumheller on DSK120RN23PROD with RULES1
B. How did EPA conduct the review of
the NPDWRs?
The protocol for the Six-Year Review
4 is organized as a series of questions to
inform an assessment as to the
appropriateness of revising an NPDWR.
These questions are logically ordered
into a decision tree. This section
provides an overview of each of the
review elements that EPA considered
for each NPDWR during the Six-Year
Review 4, including the following:
initial review, health effects, analytical
feasibility, occurrence and exposure,
treatment feasibility, risk balancing, and
other NPDWR revisions. The final
review combines the findings from all
these review elements to recommend
whether an NPDWR is a candidate for
revision. Further information about the
review elements is described in the
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
*Contaminants with an HEA process that
have an MCL based on practical
quantitation limits and are greater than the
MCLG are passed to the next question to
evaluate the potential to revise the MCL.
protocol document (USEPA, 2024c). The
results of the Six-Year Review are
presented in section V of this document.
1. Initial Review
EPA’s initial review of all the
contaminants included in the Six-Year
Review 4 involved a simple
identification of the NPDWRs that have
either been recently completed or are
being reviewed in an ongoing or
pending action since the publication of
Six-Year Review 3. In addition, the
initial review also identified
contaminants with ongoing health
effects assessments that have an MCL
equal to the MCLG. Excluding such
contaminants from a more detailed
review in the Six-Year Review 4
prevents duplicative agency efforts.
PO 00000
Frm 00037
Fmt 4700
Sfmt 4700
2. Health Effects
The principal objectives of the health
effects review are to identify: (1)
contaminants for which a new health
effects assessment indicates that a
change in the MCLG might be
appropriate (e.g., because of a change in
cancer classification or a change in
reference dose (RfD)), and (2)
contaminants for which new health
effects information indicates a need to
initiate a new health effects assessment.
To meet the first objective, EPA
reviewed the results of health effects
assessments completed since
promulgation of each NPDWR. To meet
the second objective, the agency
conducted a systematic literature
search, to capture more recently
published peer-reviewed studies on
relevant health effects via the oral route
E:\FR\FM\23JYR1.SGM
23JYR1
ER23JY24.000
Yes
No
59628
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
of exposure for the general population
as well as sensitive subpopulations
including children. The results of the
literature search were used to survey the
health effects literature that has become
available since the previous review
cycle, identify any emerging issues for
a contaminant, and identify data gaps to
inform future health assessment
nominations.
ddrumheller on DSK120RN23PROD with RULES1
3. Analytical Feasibility
When establishing an NPDWR, EPA
identifies a practical quantitation limit
(PQL), which is the lowest achievable
level of analytical quantitation during
routine laboratory operating conditions
within specified limits of precision and
accuracy (50 FR 46880, USEPA, 1985).
EPA has a separate process in place to
approve new analytical methods for
drinking water contaminants; therefore,
review and approval of potential new
methods is outside the scope of the SixYear Review protocol. EPA recognizes,
however, that the approval and
adoption in recent years of new and/or
improved analytical methods may
enable laboratories to quantify
contaminants at lower levels than was
possible when NPDWRs were originally
promulgated. This ability of laboratories
to measure a contaminant at lower
levels could affect its PQL, the value at
which an MCL is set when it is limited
by analytical feasibility. Therefore, the
Six-Year Review process includes an
examination of whether there have been
changes in analytical feasibility that
could possibly change the PQL for the
subset of the NPDWRs that reach this
stage of the review.
To determine if changes in analytical
feasibility could possibly support
changes to PQLs, EPA relied primarily
on two approaches to develop estimated
quantitation levels (EQLs), which are
based on either (1) minimum reporting
levels (MRLs) obtained as part of the
Six-Year Review 4 Information
Collection Request (ICR), or (2) method
detection limits (MDLs) from EPAapproved laboratory protocols.
An MRL is the lowest level or
contaminant concentration that a
laboratory can reliably achieve within
specified limits of precision and
accuracy under routine laboratory
operating conditions using a given
method. The MRL values provide direct
evidence from actual monitoring results
about whether quantitation below the
PQL using current analytical methods is
feasible. An MDL is a measure of
analytical sensitivity, representing the
minimum reported concentration that
can be distinguished from blank results
with 99 percent confidence. MDLs have
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
been used in the past to derive PQLs for
regulated contaminants.
EPA used the EQL as a threshold for
occurrence analysis to help the agency
assess for a meaningful opportunity to
improve public health protection. It
should be noted, however, that the use
of an EQL does not necessarily indicate
the agency’s intention to promulgate a
revised MCL based on the new PQL.
Any change in the PQL for a
contaminant could be part of future
rulemaking efforts if EPA decides to
initiate a regulatory revision for the
contaminant.
4. Occurrence and Exposure Analysis
EPA conducted the occurrence and
exposure analysis in conjunction with
other review elements to determine if an
NPDWR revision would provide a
meaningful opportunity to improve
public health by:
• estimating the extent of
contaminant occurrence, i.e., the
number of PWSs in which contaminants
occur at levels of interest (health-effectsbased thresholds or analytical method
limits), and;
• evaluating the number of people
potentially exposed to contaminants at
these levels.
To evaluate national contaminant
occurrence under the Six-Year Review
4, EPA reviewed data from the Six-Year
Review 4 ICR database (SYR 4 ICR
database) and other relevant sources.
EPA collected SDWA compliance
monitoring data and treatment
technique information through use of an
ICR (84 FR 58381, USEPA, 2019). EPA
requested that states, as well as Tribes
and territories with primacy voluntarily
submit their compliance monitoring
data and treatment technique
information for regulated contaminants
in PWSs. Specifically, EPA requested
the submission of compliance
monitoring data, treatment technique
information, and related details
collected between January 2012 and
December 2019 for regulated
contaminants and related parameters
(e.g., water quality indicators). Forty-six
states plus 13 other jurisdictions
(Washington, DC, territories, and Tribes)
provided data. The assembled data
constitute the largest, most
comprehensive set of drinking water
compliance monitoring data and
treatment technique information ever
compiled and analyzed by EPA to
inform decision making, containing
almost 71 million analytical records
from approximately 140,000 PWSs,
serving approximately 301 million
people nationally. Through extensive
data management efforts, quality
assurance evaluations, and
PO 00000
Frm 00038
Fmt 4700
Sfmt 4700
communications with state data
management staff, EPA established the
SYR 4 ICR dataset (USEPA, 2019). The
number of states and PWSs represented
in the dataset varies across
contaminants because of variability in
state data submissions and contaminant
monitoring schedules. EPA considers
that these data are of sufficient quality
to inform an understanding of the
national occurrence of regulated
contaminants and related parameters.
Details of the data management and data
quality assurance evaluations are
available in the supporting document
(USEPA, 2024d). The resulting database
is available online on the Six-Year
Review website at https://www.epa.gov/
dwsixyearreview.
5. Treatment Feasibility
An NPDWR either identifies an MCL
or establishes enforceable TT
requirements. When promulgating an
MCL or enforceable treatment technique
requirements, to determine feasibility,
EPA identifies the best technology,
treatment techniques, and other means
which EPA finds, after examination for
efficacy under field conditions and not
solely under laboratory conditions, are
available (taking cost into
consideration). When promulgating an
MCL, EPA also lists the technology,
treatment techniques, or other means
which are feasible for purposes of
meeting the MCL. EPA reviews
treatment feasibility to ascertain if
available technologies meet BAT criteria
for a hypothetical more stringent MCL,
or if new information demonstrates an
opportunity to improve public health
protection through revision of an
NPDWR TT requirement.
To be a BAT, the treatment
technology must meet several criteria
such as having demonstrated consistent
removal of the target contaminant under
field conditions. Although treatment
feasibility and analytical feasibility are
considered together in evaluating the
technical feasibility requirement for an
MCL, historically, treatment feasibility
has not been a limiting factor for MCLs.
The result of this review element is a
determination of whether treatment
feasibility would pose a limitation to
revising an MCL or provide an
opportunity to revise the NPDWR TT
requirement.
6. Risk-Balancing
EPA reviews the risk-balancing
analysis underlying some NPDWRs to
examine how a potential regulatory
revision would address tradeoffs in risks
associated with different contaminants.
Under this review, EPA considers
whether a change to an MCL and/or TT
E:\FR\FM\23JYR1.SGM
23JYR1
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
will increase the public health risk
posed by one or more contaminants,
and, if so, the agency considers
revisions that will balance overall risks.
This review element is relevant only to
the NPDWRs included in the microbial
and disinfection byproduct (MDBP)
rules, which were promulgated to
address the need for risk-balancing
between microbial and disinfection
byproduct (DBP) requirements, and
among differing types of DBPs. NPDWRs
for microbials and disinfectants and
DBPs were not reviewed during SixYear Review 4 due to ongoing regulatory
action initiated by Six-Year Review 3.
7. Other NPDWR Revisions
In addition to possible revisions to
MCLGs, MCLs, and TTs, EPA evaluated
whether other revisions are needed to
other regulatory provisions in NPDWRs,
such as monitoring and system
reporting requirements. EPA focused
this review element on issues that were
not already being addressed through
alternative mechanisms, such as a
recently completed, ongoing, or pending
regulatory action. EPA also reviewed
implementation-related NPDWR
concerns that were ‘‘ready’’ for
rulemaking—that is, the problem to be
resolved had been clearly identified,
along with specific options to address
the problem that could be shown to
either clearly improve the level of
public health protection or represent a
meaningful opportunity for achieving
cost savings while maintaining the same
59629
level of public health protection. The
result of this review element is a
determination regarding whether EPA
should consider revisions to the
monitoring and/or reporting
requirements of an NPDWR.
V. Results of EPA’s Review of NPDWRs
A. Overview of Six-Year Review 4
Results
Table 2 of this document, lists the
results of EPA’s review of the 88
NPDWRs assessed during Six-Year
Review 4, along with the principal
rationale for the review outcomes. Table
2 includes the 15 NPDWRs that have
ongoing or pending regulatory actions.
TABLE 2—SUMMARY OF SIX-YEAR REVIEW 4 RESULTS
ddrumheller on DSK120RN23PROD with RULES1
Outcome
Regulated contaminants
Not Appropriate for Revision at this Time.
Recently completed, ongoing or pending regulatory
action.
Bromate ...............................................
Chloramines (as Cl2) ...........................
Chlorine Dioxide (as ClO2) ..................
Chlorine (as Cl2) ..................................
Chlorite .................................................
Copper .................................................
Cryptosporidium (IE, LT1) 1 .................
Giardia lamblia.
Haloacetic acids (HAA5).
Heterotrophic bacteria.
Lead.
Legionella.
Total Trihalomethanes (TTHM).
Turbidity.
Viruses (SWTR, IE, LT1).1
Not Appropriate for Revision at this Time.
Health effects assessment in process or contaminant
nominated for health assessment.
Alpha/photon emitters ..........................
Arsenic .................................................
Beta/photon emitters ............................
Chromium (total) ..................................
Ethylbenzene .......................................
Mercury (inorganic).
Polychlorinated biphenyls (PCBs).
Radium 226/228 (combined).
Uranium.
No new information, NPDWR remains appropriate
after review.
Asbestos ..............................................
Benzo(a)pyrene ...................................
Chlorobenzene .....................................
Dalapon ................................................
Di(2-ethylhexyl)adipate (DEHA) ...........
Di(2-ethylhexyl)phthalate (DEHP) ........
1,2-Dibromo-3-chloropropane (DBCP)
trans-1,2-Dichloroethylene.
Dinoseb.
E. coli.
Endrin.
Ethylene dibromide.
2,4,5-TP (Silvex).
New information, but no
revision recommended
because . . .
Low priority and/or no
meaningful opportunity.
Acrylamide ...........................................
Alachlor ................................................
Antimony ..............................................
Atrazine ................................................
Barium ..................................................
Benzene ...............................................
Beryllium ..............................................
Cadmium ..............................................
Carbofuran ...........................................
Carbon Tetrachloride ...........................
Chlordane ............................................
Cryptosporidium (LT2) 1 .......................
1,2-Dichlorobenzene ............................
1,4-Dichlorobenzene ............................
1,2-Dichloroethane ...............................
1,1-Dichloroethylene ............................
cis-1,2-Dichloroethylene ......................
Dichloromethane ..................................
2,4-Dichlorophenoxyacetic acid (2,4-D)
1,2-Dichoropropane .............................
Dioxin (2,3,7,8-TCDD) .........................
Diquat.
Endothall.
Epichlorohydrin.
Glyphosate.
Heptachlor.
Heptachlor Epoxide.
Hexachlorobenzene.
Hexachlorocyclopentadiene.
Lindane.
Methoxychlor.
Oxamyl (Vydate).
Pentachlorophenol.
Picloram.
Selenium.
Simazine.
Styrene.
Tetrachloroethylene (PCE).
Thallium.
1,2,4-Trichlorobenzene.
1,1,1-Trichloroethane.
1,1,2-Trichloroethane.
Toluene.
Total Coliform.
Toxaphene.
Trichloroethylene (TCE).
Vinyl Chloride.
Xylenes.
Emerging information
and/or data gaps.
Cyanide (as free cyanide) ...................
Fluoride.
Nitrate.
Nitrite.
Candidate for Revision .....
New information.
None.
1 Regulation
abbreviations: Aircraft Drinking Water Rule (ADWR), Ground Water Rule (GWR), Revised Total Coliform Rule (RTCR), Surface
Water Treatment Rule (SWTR), Interim Enhanced Surface Water Treatment Rule (IE), Long Term 1 Enhanced Surface Water Treatment Rule
(LT1), and Long Term 2 Enhanced Surface Water Treatment Rule (LT2).
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
E:\FR\FM\23JYR1.SGM
23JYR1
59630
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
EPA has identified no appropriate
candidates for revision at this time.
EPA’s Office of Ground Water and
Drinking Water is currently engaged in
several ongoing and potential regulatory
actions, in addition to being involved in
the efforts to successfully implement
recently promulgated rules including:
• Developing a proposal to revise the
Microbial and Disinfection By-Product
Rules, including eight NPDWRs listed as
candidates for revision in Six-Year
Review 3 (85 FR 61680, USEPA, 2020a).
• On December 6, 2023, EPA
published the proposed rule ‘‘National
Primary Drinking Water for Lead and
Copper: Improvements’’ (88 FR 84878,
USEPA, 2023a).
• In January 2024, EPA announced its
commitment to promulgate a National
Primary Drinking Water Regulation for
Perchlorate by May 2027.5
• On April 26, 2024, EPA published
the PFAS final rule ‘‘PFAS National
Primary Drinking Water Regulation’’ (89
FR 32532, USEPA, 2024a).
• On May 24, 2024, EPA published
the final rule ‘‘National Primary
Drinking Water Regulations: Consumer
Confidence Reports’’ (89 FR 45980,
USEPA, 2024b).
Therefore, when evaluating the
review results described in sections V.B
and V.C of this document, EPA also
considered competing workloads and
potential diversion of resources from
these other planned, ongoing, and
pending higher priority efforts within
the drinking water office.
B. Chemical Phase Rules/Radionuclides
Rules
The NPDWRs for chemical
contaminants, collectively called the
Phase Rules, were promulgated between
1987 and 1992, following the 1986
SDWA amendments. In December 2000,
EPA promulgated final radionuclide
regulations, which had been issued as
interim rules in July 1976.
1. Key Review Outcomes
EPA has decided that it is not
appropriate at this time to revise any of
the NPDWRs covered under the Phase
or Radionuclides Rules (Table 2 of this
document). These NPDWRs were
determined not to be candidates for
revision for one or more of the following
reasons:
• ongoing/pending regulatory action
warrants waiting for further review;
• no new information was identified
to suggest possible changes in MCLG/
MCL;
• new information did not present a
meaningful opportunity for health risk
reduction or cost savings while
maintaining/improving public health
protection;
• emerging information and/or data
gaps create substantial uncertainty.
In addition, EPA is announcing that
the NPDWRs for trichloroethylene (TCE)
and tetrachloroethylene (PCE) are no
longer candidates for revision at this
time. In March 2010, as an outcome of
the second cycle of Six-Year Review,
EPA listed the TCE and PCE NPDWRs
as candidates for revision (75 FR 15500,
USEPA, 2010a). TCE and PCE were not
reviewed under Six-Year Review 3
because regulatory revisions were being
considered as part of plans to address
regulated and unregulated Carcinogenic
Volatile Organic Contaminants (cVOCs)
in a group rule (75 FR 3525, January 21,
2010; 82 FR 3531, USEPA, 2017a).
However, after evaluating currently
available information for both of these
chemicals, the EPA concludes that these
NPDWRS are not appropriate for
revision at this time because minimal
reductions in health risks would be
associated with any revisions to these
regulations. Given resource limitations,
competing workload priorities, and
administrative costs and burden to
states to adopt any regulatory changes
associated with rulemakings, as well as
limited potential health benefits, these
NPDWRs are considered a low priority
and are no longer candidates for
revision at this time.
Section V.B.2 of this document
describes the results of the review
organized by each review element.
Section V.B.3 of this document includes
a description of the new information
gathered by EPA for select contaminants
that EPA determined are not candidates
for revision at this time due to emerging
information or data gaps or no
meaningful opportunity for health risk
reduction. The contaminants discussed
in detail in section V.B.3 of this
document are cyanide, fluoride, nitrate,
nitrite, TCE, and PCE.
Review results organized by
contaminant for the Chemical Phase and
Radionuclides Rules can be found in the
‘‘Chemical Contaminant Summaries for
the Fourth Six-Year Review of National
Primary Drinking Water Regulations’’
(USEPA, 2024e).
2. Summary of Review Results
Initial Review
After conducting the initial review, as
described in section IV.B.1 of this
document, EPA identified two chemical
contaminants (lead and copper) with
NPDWRs that were considered as part of
a recently completed action, and which
are also currently part of an ongoing or
pending regulatory action. EPA
published the Lead and Copper Rule
Revisions in January 2021 and
published the proposed Lead and
Copper Rule Improvements on
December 6, 2023. EPA did not evaluate
lead and copper in Six-Year Review 4
because such effort would be redundant
with these recent and ongoing
rulemakings. EPA also identified
contaminants with ongoing or planned
EPA health effects assessments. As of
December 31, 2021, nine chemical or
radiological contaminants reviewed had
ongoing or planned formal EPA health
effects assessments. Table 3 of this
document below lists the contaminants
with ongoing or planned EPA
assessments at the time of the Six-Year
Review 4 cutoff date and the current
status of those reviews. EPA did not
conduct a detailed review of these nine
chemical and radiological contaminants
under Six-Year Review 4.
ddrumheller on DSK120RN23PROD with RULES1
TABLE 3—SIX-YEAR REVIEW CHEMICAL/RADIOLOGICAL CONTAMINANTS WITH ONGOING OR PLANNED EPA HEALTH
ASSESSMENTS
Chemical/radionuclide
Status 1
Alpha/photon emitters ...........
EPA Office of Air and Radiation (OAR) is conducting a review of alpha and beta photon emitters. Additional information about this effort can be found at in the Federal Register (87 FR 15988, USEPA, 2022a) or at: https://sab.epa.gov/ords/sab/r/sab_apex/sab_
bkup/advisoryactivitydetail?p18_id=2616&clear=18&session=8694491614209.
Inorganic arsenic is being assessed by the EPA IRIS Program. The assessment status can be found at: https://iris.epa.gov/
ChemicalLanding/&substance_nmbr=278.
EPA/OAR is conducting a review of alpha and beta photon emitters. Additional information about this effort can be found at in the
Federal Register (87 FR 15988, USEPA, 2022a) or at: https://sab.epa.gov/ords/sab/r/sab_apex/sab_bkup/
advisoryactivitydetail?p18_id=2616&clear=18&session=8694491614209.
Arsenic ...................................
Beta/photon emitters .............
5 Additional information can be found at https://
www.epa.gov/sdwa/perchlorate-drinking-water.
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
E:\FR\FM\23JYR1.SGM
23JYR1
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
59631
TABLE 3—SIX-YEAR REVIEW CHEMICAL/RADIOLOGICAL CONTAMINANTS WITH ONGOING OR PLANNED EPA HEALTH
ASSESSMENTS—Continued
Status 1
Chemical/radionuclide
Chromium VI (as part of total
Cr).
Ethylbenzene .........................
Mercury ..................................
PCBs .....................................
Radium 226/228 ....................
Uranium .................................
Chromium VI is being assessed by the EPA IRIS Program. The assessment status can be found at: https://iris.epa.gov/
ChemicalLanding/&substance_nmbr=144.
Ethylbenzene is being assessed by the EPA IRIS Program. The assessment status can be found at: https://iris.epa.gov/
ChemicalLanding/&substance_nmbr=51.
Inorganic Mercury Salts is being assessed by the EPA IRIS Program. The Assessment status can be found at: https://iris.epa.gov/
ChemicalLanding/&substance_nmbr=1522.
PCBs are being assessed by the EPA IRIS Program. The assessment status can be found at: https://iris.epa.gov/ChemicalLanding/
&substance_nmbr=294.
EPA/OAR is conducting a review of radium. Additional information about this effort can be found at in the FEDERAL REGISTER (87 FR
15988, USEPA, 2022a) or at: https://sab.epa.gov/ords/sab/r/sab_apex/sab_bkup/advisoryactivitydetail?p18_
id=2616&clear=18&session=8694491614209.
Uranium is being assessed by the EPA IRIS Program. The assessment status can be found at: https://iris.epa.gov/ChemicalLanding/
&substance_nmbr=259.
1 Additional information on the status of EPA IRIS Program assessments can be found in the EPA IRIS Program Outlooks at https://www.epa.gov/iris/iris-programoutlook.
Regarding the ongoing health
assessment for Chromium VI
(hexavalent chromium), on October 20,
2022 the EPA published its draft ‘‘IRIS
Toxicological Review of Hexavalent
Chromium [Cr(IV)]’’ (87 FR 63774,
USEPA, 2022b). This draft health effects
assessment, which includes a
comprehensive evaluation of potential
health effects, preliminarily categorizes
hexavalent chromium as likely
carcinogenic to humans via the oral
exposure pathway. The final IRIS
assessment was not available as of the
publication of this document and for
consideration as part of Six-Year Review
4. When this human health assessment
is final, EPA will carefully review the
conclusions and consider all relevant
information to determine whether the
assessment by EPA, a more detailed
review was undertaken. Of the
chemicals that underwent a more
detailed review, EPA identified 29
contaminants for which an updated RfD
and/or the cancer risk assessment (from
oral exposure) or new relevant non-EPA
assessments might support a change to
the MCLG. These 29 chemicals were
further evaluated as part of the Six-Year
Review 4 to determine whether they
were candidates for regulatory revision.
Table 4 of this document lists the
chemicals with available new health
effects information and the sources of
the relevant new information. As shown
in this table, 15 chemical contaminants
have information that could support a
lower MCLG, and 14 contaminants have
new information that could support a
higher MCLG.
NPDWR for chromium is a candidate for
revision.
After the initial review was
completed, EPA identified 71 chemical
and radiological NPDWRs that were
appropriate for detailed review.
Health Effects
The principal objectives of the health
effects assessment review were to
identify: (1) contaminants for which a
new health effects assessment indicates
that a change in MCLG might be
appropriate (e.g., because of a change in
cancer classification or an RfD), and (2)
contaminants for which the agency has
identified new health effects
information suggesting a need to initiate
a new health effects assessment. For
chemicals that were not excluded due to
an ongoing or planned health effects
TABLE 4—CHEMICALS WITH NEW HEALTH ASSESSMENTS THAT COULD SUPPORT A CHANGE IN MCLG
Chemical
Relevant new assessment
15 Contaminants with Potential to Decrease the MCLG
ddrumheller on DSK120RN23PROD with RULES1
Antimony ...................................................................................................
Cadmium ..................................................................................................
Carbofuran ................................................................................................
Cyanide .....................................................................................................
cis-1,2-Dichloroethylene ...........................................................................
Endothall ...................................................................................................
Fluoride .....................................................................................................
Hexachlorocyclopentadiene ......................................................................
Methoxychlor ............................................................................................
Oxamyl ......................................................................................................
Selenium ...................................................................................................
Styrene .....................................................................................................
Toluene .....................................................................................................
1,2,4-Trichlorobenzene .............................................................................
Xylenes .....................................................................................................
CalEPA, 2016.
ATSDR, 2012.
USEPA OPP, 2008.
USEPA IRIS, 2010b.
USEPA IRIS, 2010c.
USEPA OPP, 2015b.
USEPA OW, 2010d.
USEPA IRIS, 2001.
CalEPA, 2010a.
USEPA OPP, 2017b.
ATSDR, 2003.
CalEPA, 2010b.
Health Canada, 2014.
USEPA PPRTV, 2009a.
Health Canada, 2014.
14 Contaminants with Potential to Increase the MCLG
Alachlor .....................................................................................................
Atrazine .....................................................................................................
Barium ......................................................................................................
Beryllium ...................................................................................................
2,4-Dichlorophenoxy-acetic acid (2,4-D) ..................................................
1,2-Dichlorobenzene .................................................................................
1,4-Dichlorobenzene .................................................................................
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
PO 00000
Frm 00041
Fmt 4700
USEPA OPP, 2007a.
USEPA OPP, 2018a.
USEPA IRIS, 2005.
USEPA IRIS, 1998.
USEPA OPP, 2017c.
ATSDR, 2006.
ATSDR, 2006.
Sfmt 4700
E:\FR\FM\23JYR1.SGM
23JYR1
59632
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
TABLE 4—CHEMICALS WITH NEW HEALTH ASSESSMENTS THAT COULD SUPPORT A CHANGE IN MCLG—Continued
Chemical
Relevant new assessment
1,1-Dichloroethylene .................................................................................
Diquat .......................................................................................................
Glyphosate ................................................................................................
Lindane .....................................................................................................
Picloram ....................................................................................................
Simazine ...................................................................................................
1,1,1-Trichloroethane ................................................................................
Details of the health effects
assessment review of the chemical and
radiological contaminants are
documented in the ‘‘Results of the
Health Effects Assessment for the
Fourth Six-Year Review of Existing
Chemical and Radionuclide National
Primary Drinking Water Standards’’
(USEPA, 2024f).
ddrumheller on DSK120RN23PROD with RULES1
Analytical Feasibility
EPA performed analytical feasibility
analyses for the contaminants that
reached this portion of the review.
These contaminants included the 15
chemical contaminants identified under
the health effects assessment review as
having potential for a lower MCLG. EPA
evaluated whether there were any
analytical limitations to lowering the
MCL to the potential MCLG. EPA also
evaluated an additional 22
contaminants with MCLs higher than
the current MCLGs due to analytical
limitations at the time of rule
promulgation. The document
‘‘Analytical Feasibility Support
Document for the Fourth Six-Year
Review of National Primary Drinking
Water Regulations: Chemical Phase and
Radionuclides Rules’’ (USEPA, 2024g)
describes the process EPA used to
evaluate whether changes in PQL are
possible in those instances where the
MCL may be limited by analytical
feasibility.
Table 5 of this document shows the
outcomes of EPA’s analytical feasibility
review for two general categories of
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
USEPA
USEPA
USEPA
USEPA
USEPA
USEPA
USEPA
IRIS, 2002.
OPP, 2020b.
OPP, 2017d.
OPP, 2004.
OPP, 2020c.
OPP, 2018b.
IRIS, 2007b.
drinking water contaminants: (1)
contaminants where health effects
assessments indicate potential for lower
MCLGs, and (2) contaminants where
existing MCLs were limited by
analytical feasibility at the time of
promulgation and new information
indicates a potential to reduce the PQL.
• A health effects assessment
indicates potential for lower MCLG. This
category includes the 15 contaminants
identified in the health effects review as
having potential for a lower MCLG. EPA
reviewed the available information to
determine if analytical feasibility could
limit the potential for MCL revisions.
The current PQL is not a limiting factor
for seven of the 15 contaminants
identified by the health effects review as
potential candidates for lower MCLGs
(cis-1,2-dichloroethylene, fluoride,
hexachlorocyclopentadiene, oxamyl,
selenium, toluene, and xylenes). For the
remaining eight contaminants, the
current PQL is higher than the potential
new MCLG, so EPA evaluated whether
there is an opportunity to lower the
PQL. The evaluations indicated that all
but one contaminant (antimony) have
potential for a lower PQL, although not
to the potential MCLG. Consequently,
analytical feasibility may limit potential
MCL revisions for the remaining seven
contaminants (Table 5 of this
document).
• Existing MCLs are based on
analytical feasibility. This category
includes 22 contaminants with existing
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
MCLs that are greater than the
associated MCLGs due to analytical
constraints at the time of rule
promulgation. Two of the contaminants
(thallium and 1,1,2-trichloroethane) are
non-carcinogenic and have a non-zero
MCLG, and the remaining 20
contaminants are carcinogens with
MCLGs equal to zero. EPA evaluated
whether the PQL could be lowered for
each of these contaminants. The
evaluations indicated that all but five
(benzo[a]pyrene, DBCP, DEHP, ethylene
dibromide, PCBs) of the 22
contaminants evaluated have potential
for a lower PQL (Table 5 of this
document).
Where analytical feasibility
evaluations indicated the potential for a
PQL reduction, Table 5 of this
document lists the type of data that
support this conclusion. The types of
data considered include laboratory
proficiency tests (PT), method detection
limits (MDL) from EPA-approved
methods, and minimum reporting level
(MRL) from the SYR 4 ICR dataset. The
methods to evaluate each of these data
types to identify potential to reduce
PQLs are described in the analytical
feasibility support document (USEPA,
2024g). Where the evaluations indicated
that the current PQL remained
appropriate, Table 5 shows of this
document ‘‘Data do not support PQL
reduction.’’ EPA found information
supporting potentially lower MCLs for
31 out of 37 contaminants evaluated.
E:\FR\FM\23JYR1.SGM
23JYR1
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
59633
TABLE 5—ANALYTICAL FEASIBILITY REASSESSMENT RESULTS
Current PQL
(μg/L)
Contaminant
Analytical feasibility reassessment result
(and source of new information) 1
15 Contaminants Identified Under the Health Effects Review as Having Potential for Lower MCLG
Antimony .....................................................................................
Cadmium .....................................................................................
Carbofuran ..................................................................................
Cis-1,2-dichloroethylene .............................................................
Cyanide .......................................................................................
Endothall .....................................................................................
Fluoride .......................................................................................
Hexachlorocyclopentadiene ........................................................
Methoxychlor ...............................................................................
Oxamyl ........................................................................................
Selenium .....................................................................................
Styrene ........................................................................................
Toluene .......................................................................................
Xylenes .......................................................................................
1,2,4-Trichlorobenzene ...............................................................
6
2
7
5
100
90
500
1
10
20
10
5
5
5
5
Data do not support PQL reduction.
PQL reduction supported (MDL, MRL).
PQL reduction supported (MDL).
PQL not limiting.
PQL reduction supported (MDL).
PQL reduction supported (MDL, MRL).
PQL not limiting.
PQL not limiting.
PQL reduction supported (MDL, MRL, PT).
PQL not limiting.
PQL not limiting.
PQL reduction supported (MDL, MRL, PT).
PQL not limiting.
PQL not limiting.
PQL reduction supported (MDL, MRL, PT).
22 Contaminants with MCLs Limited by Analytical Feasibility and Higher than MCLGs
Benzene ......................................................................................
Benzo[a]pyrene ...........................................................................
Carbon tetrachloride ...................................................................
Chlordane ....................................................................................
1,2-Dibromo-3-chloropropane (DBCP) .......................................
1,2-Dichloroethane ......................................................................
Dichloromethane .........................................................................
1,2-Dichloropropane ....................................................................
Di(2-ethylhexyl)phthalate (DEHP) ...............................................
Ethylene dibromide .....................................................................
Heptachlor ...................................................................................
Heptachlor epoxide .....................................................................
Hexachlorobenzene ....................................................................
Pentachlorophenol ......................................................................
PCBs ...........................................................................................
2,3,7,8-TCDD (dioxin) .................................................................
Tetrachloroethylene ....................................................................
Thallium .......................................................................................
Toxaphene ..................................................................................
1,1,2-Trichloroethane ..................................................................
Trichloroethylene .........................................................................
Vinyl chloride ...............................................................................
5
0.2
5
2
0.2
5
5
5
5
0.05
0.4
0.2
1
1
0.5
0.00003
5
2
3
5
5
2
PQL reduction supported (MDL, MRL, PT).
Data do not support PQL reduction.
PQL reduction supported (MDL, MRL, PT).
PQL reduction supported (MDL).
Data do not support PQL reduction.
PQL reduction supported (MDL, MRL, PT).
PQL reduction supported (MDL, MRL, PT).
PQL reduction supported (MDL, MRL, PT).
Data do not support PQL reduction.
Data do not support PQL reduction.
PQL reduction supported (MDL).
PQL reduction supported (MDL).
PQL reduction supported (MDL, MRL).
PQL reduction supported (MDL).
Data do not support PQL reduction.
PQL reduction supported (MRL).
PQL reduction supported (MDL, MRL).
PQL reduction supported (MRL).
PQL reduction supported (MRL, PT).
PQL reduction supported (MDL, MRL, PT).
PQL reduction supported (MDL, MRL, PT).
PQL reduction supported (MDL, MRL, PT).
1 The information source codes refer to the method detection limit (MDL), minimum reporting level (MRL), and proficiency testing (PT) data
analyses. See USEPA (2024g) for further information.
ddrumheller on DSK120RN23PROD with RULES1
Occurrence and Exposure
Using the SYR 4 ICR database, EPA
conducted an assessment to evaluate
national occurrence of regulated
contaminants and estimate the potential
population exposed to these
contaminants. The details of the current
chemical occurrence analysis are
documented in the ‘‘Analysis of
Regulated Contaminant Occurrence Data
from Public Water Systems in Support
of the Fourth Six-Year Review of
National Primary Drinking Water
Regulations: Chemical Phase Rules and
Radionuclides Rules’’ (USEPA, 2024h).
Based on quantitative benchmarks
which were identified in the health
effects and analytical feasibility
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
analyses, EPA conducted the occurrence
and exposure analysis for 31
contaminants.
This analysis shows that 27 of the 31
contaminants assessed rarely occur at
levels above the identified benchmark
(e.g., potential MCLG or PQL). For these
27 contaminants, monitoring results
only exceeded benchmarks in a very
small percentage (i.e., less than 0.5
percent) of systems, which serve a very
small percentage of the population,
indicating that revisions to NPDWRs are
unlikely to provide a meaningful
opportunity to improve public health
protection at the national level.
Therefore, these 27 contaminants were
not further considered as candidates for
regulatory revision. The other four
PO 00000
Frm 00043
Fmt 4700
Sfmt 4700
contaminants (cyanide, fluoride, TCE,
and PCE) occurred at rates ranging from
0.57 to 9.1 percent of systems within the
SYR 4 ICR dataset and 3.4 to 6.3 percent
of the population served by those
systems. Additional considerations for
cyanide, fluoride, TCE, and PCE are
discussed in section V.B.3 of this
document. Table 6 of this document
lists the numerical benchmarks used to
conduct the occurrence analysis, the
total number of systems with mean
concentrations exceeding a benchmark,
and the estimated population served by
those systems. These average
concentration-based evaluations are
intended to inform the Six-Year Review,
not to assess compliance with regulatory
standards.
E:\FR\FM\23JYR1.SGM
23JYR1
59634
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
TABLE 6—OCCURRENCE AND POTENTIAL EXPOSURE ANALYSIS FOR CHEMICAL NPDWRS
Current MCL
(ug/L)
Contaminant
Benchmark 1
(ug/L)
Number
(and percentage)
of systems with
a mean
concentration 2
higher than
benchmark
Population served
by systems with
a mean concentration
higher than
benchmark
(and percentage of
total population)
Contaminants Identified Under the Health Effects Review as Having Potential for Lower MCLG
Cadmium .......................................................................................................................
Carbofuran ....................................................................................................................
Cyanide .........................................................................................................................
cis-1,2-Dichloroethylene ................................................................................................
Endothall .......................................................................................................................
Fluoride 4 .......................................................................................................................
Hexachlorocyclopentadiene ..........................................................................................
Methoxychlor .................................................................................................................
Oxamyl ..........................................................................................................................
Selenium .......................................................................................................................
Styrene ..........................................................................................................................
Toluene .........................................................................................................................
1,2,4-Trichlorobenzene .................................................................................................
Xylenes (total) ...............................................................................................................
5
40
200
70
100
4,000
50
40
200
50
100
1,000
70
10,000
1
5
50
10
50
900
40
1
9
30
0.5
60
0.5
80
182
37
328
7
(0.36%)
(0.02%)
(0.85%)
(0.01%)
0
4,479 (9.05%)
0
1 (<0.01%)
3 7 (0.02%)
91 (0.18%)
89 (0.17%)
14 (0.03%)
15 (0.03%)
23 (0.05%)
430,823 (0.16%)
(0.02%)
8,134,220 (3.43%)
42,215 (0.02%)
0
17,058,830 (6.30%)
0
22,536 (0.01%)
3 52,677 (0.02%)
84,988 (0.03%)
27,473 (0.01%)
5,256 (<0.01%)
126,201 (0.05%)
34,728 (0.01%)
83 (0.16%)
90 (0.17%)
1 (<0.01%)
60 (0.11%)
215 (0.41%)
41 (0.08%)
1 (<0.01%)
3 (0.01%)
6 (0.02%)
0
7 (0.11%)
432 (0.83%)
71 (0.14%)
2 (0.01%)
2 (<0.01%)
297 (0.57%)
24 (0.05%)
319,633 (0.12%)
766,891 (0.28%)
240 (<0.01%)
181,041 (0.07%)
360,289 (0.13%)
34,800 (0.01%)
900 (<0.01%)
32,710 (0.01%)
17,278 (0.01%)
0
2,311 (<0.01%)
15,811,810 (5.76%)
57,541 (0.02%)
335 (<0.01%)
50 (<0.01%)
12,755,926 (4.65%)
307,275 (0.11%)
3 49,409
Contaminants with MCLs Higher than MCLGs (Limited by Analytical Feasibility)
Benzene ........................................................................................................................
Carbon tetrachloride ......................................................................................................
Chlordane ......................................................................................................................
1,2-Dichloroethane ........................................................................................................
Dichloromethane ...........................................................................................................
1,2-Dichloropropane ......................................................................................................
Heptachlor .....................................................................................................................
Heptachlor epoxide .......................................................................................................
Hexachlorobenzene ......................................................................................................
Pentachlorophenol ........................................................................................................
2,3,7,8-TCDD (dioxin) ...................................................................................................
Tetrachloroethylene (PCE) ............................................................................................
Thallium .........................................................................................................................
Toxaphene ....................................................................................................................
1,1,2-Trichloroethane ....................................................................................................
Trichloroethylene (TCE) ................................................................................................
Vinyl chloride .................................................................................................................
5
5
2
5
5
5
0.4
0.2
1
1
0.00003
5
2
3
5
5
2
0.5
0.5
1
0.5
0.5
0.5
0.1
0.1
0.1
0.9
0.000005
0.5
1
1
3
0.5
0.5
ddrumheller on DSK120RN23PROD with RULES1
1 Benchmark screening levels were set to either potential maximum contaminant level goals (MCLGs) or estimated quantitation levels (EQLs), depending on the
contaminant. For more information see USEPA (2024g).
2 Results are based on long-term means generated by substituting one-half the MRL for each non-detection record. For results based on substituting the value of
the full MRL or zero see USEPA (2024h).
3 Oxamyl and carbofuran have health endpoints associated with acute exposure and are not appropriate for long-term mean estimates. Results show the number of
systems with at least one detection exceeding the benchmark.
4 Estimates represent naturally occurring fluoride concentrations. Quality assurance steps were taken to exclude samples from fluoridated water systems. See
USEPA (2024i) for details.
In addition, EPA performed a source
water occurrence analysis for the 15
chemical contaminants in which
updated health effects assessments
indicated the possibility to increase (i.e.,
render less stringent) the MCLG values.
EPA conducted this analysis to assess
for meaningful opportunity to achieve
cost savings while maintaining or
improving the level of public health
protection. The data available to
characterize contaminant occurrence
was limited because a comprehensive
dataset to characterize drinking water
source quality is not available. Data
from the U.S. Geological Survey (USGS)
National Water Quality Assessment
program and the U.S. Department of
Agriculture Pesticide Data Program
water monitoring survey provide useful
insights into potential contaminant
occurrence in source water. The
analysis of the available contaminant
occurrence data for potential drinking
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
water sources indicated relatively low
contaminant occurrence in the
concentration ranges of interest, and
consequently, no meaningful
opportunity for system cost savings by
increasing the MCLG and MCL for these
15 contaminants. The results of this
analysis were documented in
‘‘Occurrence Analysis for Potential
Source Waters for the Fourth Six-Year
Review of National Primary Drinking
Water Regulations’’ (USEPA, 2024j).
Treatment Feasibility
Currently, all of the MCLs for
chemical and radiological contaminants
are either (1) set equal to the MCLGs, (2)
limited by analytical feasibility, or (3)
set at the level at which health risk
reduction benefits were maximized at a
cost justified by the benefits; none are
currently limited by treatment
feasibility. EPA considers treatment
feasibility after identifying
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
contaminants with the potential to
lower the MCLG/MCL that constitute a
meaningful opportunity to improve
public health. No such contaminants
were identified in the occurrence and
exposure analysis described above.
Treatment techniques were
promulgated for two of the chemical
and radiological contaminants that were
subject to a detailed review in Six-Year
Review 4. Acrylamide and
epichlorohydrin occur in drinking water
as treatment impurities and are
primarily introduced as residuals in
polymers and copolymers used for
water treatment. There are no
standardized analytical methods for
their measurement in water; instead of
sampling, water systems must certify to
the State in writing that they use
products meeting the specifications in
the NPDWR. To evaluate the potential to
revise the NPDWRs for these
contaminants, EPA obtained data from
E:\FR\FM\23JYR1.SGM
23JYR1
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
NSF on analyses for approval of
products against NSF/ANSI Standard
60, which are based on EPA’s
regulation. NSF certification data shows
that manufactured products contain
acrylamide and epichlorohydrin
impurity levels far below the current
regulatory standard. Specifically, the
mean residual acrylamide concentration
of certified products is one-fifth of the
current regulatory level and the 90th
percentile is one-half. There were no
samples with detections of residual
epichlorohydrin. The available data
indicates that the majority of tested
products already pose lower health risks
than required under the current TT, and
therefore, revisions are a low priority.
EPA is not listing acrylamide and
epichlorohydrin as candidates for
revision at this time. See USEPA
(2024k) for details.
Other Regulatory Revisions
In addition to possible revisions to
MCLGs, MCLs, and TTs, as a part of the
Six-Year Review 4, EPA considered
whether other regulatory revisions to
NPDWRs are needed to address
implementation issues, such as
revisions to monitoring and system
reporting requirements. EPA used the
protocol to evaluate which
implementation issues to consider
(USEPA, 2024c). EPA’s protocol focused
on items that were not already being
addressed, or had not yet been
addressed, through alternative
mechanisms (e.g., as a part of a recent
or ongoing rulemaking).
EPA compiled information on
implementation-related issues
associated with the Chemical Phase
Rules. EPA also identified unresolved
implementation issues and concerns
from previous Six-Year Reviews. The
complete list of implementation issues
related to the Phase and Radionuclides
Rules is presented in ‘‘Consideration of
Other Regulatory Revisions in Support
of the Fourth Six-Year Review of the
National Primary Drinking Water
59635
Regulations: Chemical Phase Rules and
Radionuclides Rules’’ (USEPA, 2024l).
The agency focused on the following
five implementation issues in the SixYear Review 4:
• Use of an alternative MCL for nitrate
in Noncommunity Water Systems
(NCWSs)
• Frequency of nitrate monitoring in
Transient Noncommunity Water
Systems (TNCWS)
• Frequency of nitrite monitoring
• Total nitrate-nitrogen plus nitritenitrogen MCL
• Total cyanide screening for free
cyanide
Table 7 of this document provides a
brief description of the five issues and
identified potential ways of addressing
them. Please see section V.B.3. of this
document for a discussion of these
contaminants and their review
outcomes. Please see USEPA (2024l) for
a more detailed description and
estimated scope of these issues.
TABLE 7—CHEMICAL RULE IMPLEMENTATION ISSUES IDENTIFIED THAT FALL WITHIN THE SCOPE OF AN NPDWR REVIEW
Implementation issue
Description of issue
Nitrate Alternative MCL in Non-community Water Systems.
EPA evaluated the possibility of removing or further restricting the options for some NCWSs to use
an alternative nitrate-nitrogen MCL of up to 20 mg/L. The nitrate-nitrogen MCL specified for PWSs
in 40 CFR 141.62 is 10 mg/L and is based on the critical health endpoint of methemoglobinemia
in children under six months of age. 40 CFR 141.11 provides States the discretion to use an alternative MCL of 20 mg/L for non-community water systems (NCWS). This alternative MCL is allowed under certain conditions—including that water would be unavailable to children under six
months of age.
Monitoring requirements for nitrate-nitrogen are specified in the introductory text to 40 CFR 141.23,
which states that ‘‘Non-transient, non-community water systems shall conduct monitoring to determine compliance with the maximum contaminant levels specified in § 141.62 in accordance with
this section. Transient, non-community water systems (TNCWS) shall conduct monitoring to determine compliance with the nitrate and nitrite MCL in §§ 141.11 and 141.62 (as appropriate) in accordance with this section.’’
Potential concerns with the current rule provisions were identified as:
• The alternative MCL does not address any nitrate-induced health concerns beyond
methemoglobinemia and
• While § 141.11 allows the use of the alternative MCL by all eligible NCWS, § 141.23 implies
that only TNCWS, a subcategory of NCWS, are eligible to use the alternative MCL.
To determine the scope of this issue, the agency reviewed state drinking water regulations and analyzed SYR 4 ICR nitrate compliance data and identified nominal application of the alternative nitrate MCL by NCWSs. In addition, the nitrate and nitrite human health assessments are currently
being evaluated by the EPA IRIS program. An updated assessment could inform the potential
health effects of nitrate exposure to levels between 10 and 20 mg/L on adult populations. EPA will
consider all available and updated human health assessments as it conducts future cycles of the
six-year review.
Currently, community water systems (CWSs) and NTNCWSs are required to monitor for nitrate quarterly if a sample is greater than or equal to 50 percent of the nitrate MCL (§ 141.23). TNCWSs are
required to monitor for nitrate annually (§ 141.23(d)(4)). In the preamble to the 1991 final Phase II
rule, the agency describes TNCWSs as being subject to the quarterly monitoring requirement stating that ‘‘EPA has decided to retain the 50 percent trigger for increased nitrate monitoring in the
case of nitrate and also to extend this requirement to TWSs’’ (56 FR 3566, USEPA, 1991).
EPA notes the conflict between the regulatory text and the preamble. To evaluate whether it may be
appropriate to revise the nitrate NPDWR, the agency analyzed compliance monitoring data collected under the SYR 4 ICR. EPA found that while the majority of TNCWSs that reported detections equal or greater than 50 percent of the nitrate MCL did not conduct quarterly monitoring
afterward, the number of these systems appears relatively small. Due to the limited scope of this
issue, EPA is not revising the monitoring requirements at this time but will consider monitoring requirements if NPDWRs are revised in the future.
ddrumheller on DSK120RN23PROD with RULES1
Nitrate Monitoring Frequency in Transient
Noncommunity Water Systems.
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
PO 00000
Frm 00045
Fmt 4700
Sfmt 4700
E:\FR\FM\23JYR1.SGM
23JYR1
59636
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
TABLE 7—CHEMICAL RULE IMPLEMENTATION ISSUES IDENTIFIED THAT FALL WITHIN THE SCOPE OF AN NPDWR REVIEW—
Continued
Implementation issue
Description of issue
Nitrite Monitoring Frequency .....................
According to 40 CFR 141.23(e)(1), all PWSs were required to monitor for nitrite once between January 1, 1993, and December 31, 1995. If this initial sample was less than 50 percent of the MCL
(10 mg/L), systems ‘‘shall monitor at the frequency specified by the State‘‘. Though the nitrite
monitoring frequency is not explicitly stated in the CFR, EPA’s guidance provides that this frequency should be at least once every 9-year compliance cycle (USEPA, 2020d). EPA is aware
that some States may not require systems to conduct routine nitrite monitoring when sample results are less than 50 percent of the MCL. Because sample results below the MCL are not reported to EPA, the scope of this issue is uncertain.
To address this uncertainty, EPA analyzed State regulations and nitrite compliance monitoring data
to characterize the frequency of nitrite monitoring. Results indicated that a majority of systems
monitored for nitrite at least once during the last 9-year compliance cycle (2011–2019). EPA intends to work with States to encourage more systems to sample for nitrite at least once during
each 9-year compliance cycle.
In 40 CFR 141.62, the MCL for nitrate is specified as 10 mg/L and the MCL for total nitrate and nitrite is also specified as 10 mg/L. Sampling and analytical requirements as specified in 40 CFR
141.23, however, only included nitrate and left total nitrate and nitrite monitoring up to the discretion of States. Using Safe Drinking Water Information System (SDWIS) compliance data, EPA is
aware that at least half of the States allow total nitrate/nitrite analysis to determine compliance
with the nitrate MCL.
To characterize monitoring practices for the nitrate MCL, the Agency analyzed Six-Year Review 4
compliance monitoring data for both nitrate and total nitrate/nitrite. This evaluation aims to serve
as a baseline to assess nitrate monitoring practices in the future, in response to the 2020 EPA
guidance outlining best practices when using total nitrate/nitrite analysis for monitoring compliance
with the nitrate MCL. EPA is not revising the monitoring requirements at this time but will consider
monitoring requirements in § 141.23 if NPDWRs are revised in the future, to incorporate best practices similar to those described in recent guidance (USEPA, 2020e).
Total Nitrate and Nitrite Analysis for Nitrate MCL Monitoring.
3. Select NPDWRs With New
Information Not Appropriate for
Revision
The NPDWRs discussed in this
section had new information identified,
but EPA has determined they are not
appropriate for revision at this time due
to: (1) data gaps or emerging information
that are necessary for EPA to evaluate as
part of a review or; (2) new information
that suggests low or no meaningful
opportunity to provide greater public
health protection. Examples of data gaps
and emerging information identified
during the review include an analytical
monitoring challenge, a compliance
reporting limitation, and an anticipated
health effects assessment being
developed by another U.S. Federal
Agency. Specific details about the data
gaps and emerging information
identified during the review for on
cyanide, fluoride, nitrate, nitrite, TCE,
and PCE are provided below.
ddrumheller on DSK120RN23PROD with RULES1
Cyanide
EPA published the current MCL and
MCLG of 0.2 mg/L (200 mg/L) for free
cyanide on July 17, 1992 (57 FR 31776,
USEPA, 1992). In 2010, EPA published
an IRIS assessment (USEPA, 2010b),
which identified a new reproductive
health effect endpoint that supports
decreasing the MCLG from 200 mg/L to
4 mg/L. Analytical feasibility
information identified in Six-Year
Review 3 and Six-Year Review 4
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
supports a PQL reduction to as low as
50 mg/L. In Six-Year Review 3, cyanide
was listed as ‘‘low priority’’ due to low
occurrence at levels below the current
MCL. Analysis of Six-Year Review 4
occurrence data identified greater
occurrence with 328 systems serving 8.1
million people with mean
concentrations above 50 mg/L (see Table
6 of this document). However,
occurrence was limited to few states
(USEPA, 2024h). EPA considered these
occurrence results and the potential for
a meaningful opportunity to improve
the level of public health protection.
Two analytical monitoring challenges
complicate interpretation of the
occurrence data. As described in section
V.B.2 of this document, an analytical
artifact created by ascorbic acid
pretreatment of drinking water samples,
which had been disinfected with
chloramines, can result in false
positives for free cyanide (USEPA,
2020f). An EPA guidance document
(USEPA, 2020f) identified solutions to
address this analytical challenge, but
the general awareness of the availability
of this guidance is uncertain. Second,
EPA is aware that some systems analyze
samples for total cyanide, and if the
results are lower than the MCL, these
systems report the total cyanide results
as free cyanide. Systems may achieve
cost savings by analyzing samples for
total cyanide; however, using results for
total cyanide instead of free cyanide
could potentially overestimate the
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
actual occurrence of free cyanide. Free
and total cyanide results cannot be
distinguished in the Six-Year Review 4
ICR dataset because the Safe Drinking
Water Information System (SDWIS)
State-version that many primacy
agencies use to manage SDWA
compliance monitoring data does not
have an analyte code for total cyanide.
Because the numerical benchmark used
for occurrence is significantly lower
than the current cyanide MCL, some of
the reported concentrations may be for
total cyanide. Therefore, the Six-Year
Review 4 occurrence analysis likely
overestimates free cyanide occurrence.
For these reasons, EPA does not believe
it is appropriate to list the cyanide
NPDWR as a candidate for revision at
this time. EPA intends to help address
these data gaps by continuing to
disseminate the 2020 guidance on
analytical methods for cyanide and may
consider an additional analyte code for
total cyanide in the SDWIS reporting
system. Further discussion of the
cyanide monitoring issues can be found
in USEPA (2024h).
Fluoride
EPA published the MCL and MCLG of
4.0 mg/L for fluoride on April 2, 1986
(51 FR 11396, USEPA, 1986) based on
the critical health endpoint of crippling
skeletal fluorosis. EPA also established
a secondary MCL/MCLG at 2.0 mg/L to
protect against cosmetically
objectionable dental fluorosis
E:\FR\FM\23JYR1.SGM
23JYR1
ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
(discoloration and/or pitting of teeth).
Certain drinking water systems may
choose to fluoridate finished water as a
public health protection measure for
reducing the incidence of cavities. The
U.S. Public Health Service (PHS)
recommendation for the optimal
community water fluoridation level is
0.7 mg/L (U.S. Department of Health
and Human Services, 2015). The
decision to fluoridate a community
water supply is made by the state or
local municipalities and is not required
by EPA or any other federal entity.
Fluoride is also added to various
consumer products, such as toothpaste
and mouthwash.
EPA has reviewed the NPDWR for
fluoride in prior Six-Year Reviews. As a
result of Six-Year Review 1, EPA
requested that the National Research
Council (NRC) of the National
Academies of Sciences (NAS) conduct a
review of the health and exposure data
on orally ingested fluoride. In 2006, the
NRC published the results of its review
and concluded that severe dental
fluorosis can be an adverse health effect
(NRC, 2006). The NRC report
recommended that EPA develop a doseresponse assessment for severe dental
fluorosis as the critical health endpoint
and update an assessment of fluoride
exposure from all sources.
In 2010, EPA published Dose
Response Analysis for Noncancer
Effects (USEPA, 2010d), which was
considered under Six-Year Review 3.
For more information, please see
Appendix C of the Six-Year Review 3
Health Effects Assessment for Existing
Chemical and Radionuclide National
Primary Drinking Water Regulations—
Summary Report (USEPA, 2016). In SixYear Review 3, EPA did not recommend
the fluoride NPDWR for revisions citing
limited agency resources, prioritization
of other contaminants, ongoing health
effects research, and other factors that
were anticipated to reduce the U.S.
population’s exposure to fluoride via
drinking water (82 FR 3531, USEPA,
2017a). In Six-Year Review 4, EPA again
considered the 2010 EPA assessment to
derive a lower potential MCLG of 0.9
mg/L. Review results are provided in
section V.B.2. of this document.
Available published literature on
other health effect categories including
neurotoxicity and behavior,
reproduction and development,
endocrine effects, and cancer were
reviewed in the EPA assessment
(USEPA, 2010d). However, based on the
review of the available literature at the
time, EPA determined that the data for
these other health effects associated
with fluoride exposure were insufficient
to support their selection as critical
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
effects for potential MCLG derivation
(USEPA, 2010d). EPA is aware of
ongoing efforts by the National
Toxicology Program (NTP) to conduct a
systematic review and meta-analysis of
the published literature on
developmental neurotoxicity for
fluoride. In May 2023, NTP released the
Draft ‘‘NTP Monograph on the State of
the Science Concerning Fluoride
Exposure and Neurodevelopmental and
Cognitive Health Effects: A Systematic
Review’’ (NTP, 2023); however, the NTP
systematic review and meta-analysis are
not health assessments that could be
used to directly inform the derivation of
a potential MCLG. Due to emerging
research published on developmental
neurotoxicity after fluoride exposure
coupled with competing workloads and
other ongoing high priority actions (see
section V.A of this document.), EPA has
decided that the fluoride NPDWR is not
a candidate for revision at this time. In
addition, the NTP has not made a final
decision about the report’s
developmental neurotoxicity systematic
review conclusions and has not formally
released a final report. Following
publication of the final NTP report, EPA
will consider the systematic review and
meta-analysis conclusions regarding
developmental neurotoxicity to inform
the agency’s future development of a
health effects assessment for fluoride.
See USEPA (2024f) Appendix B for
more information.
Nitrate and Nitrite
EPA published the MCLs and MCLGs
for nitrate (10 mg/L) and nitrite (1 mg/
L) based on the critical endpoint of
methemoglobinemia (blue baby
syndrome) on January 30, 1991 (56 FR
3526, USEPA, 1991). Nitrate and nitrite
were not reviewed in detail under SixYear Review 3 due to ongoing IRIS
assessments at that time. Although the
development of the IRIS assessment for
nitrate and nitrite was suspended in
December 2018, EPA has restarted
development of their health assessment
for nitrate and nitrite as indicated in the
October 2023 IRIS Program Outlook.
The agency recently released the
‘‘Protocol for the Nitrate and Nitrite IRIS
Assessment (Oral)’’ for public comment
on November 9, 2023 (88 FR 77310,
USEPA, 2023b). EPA plans to evaluate
whether a revision of the nitrate and
nitrite NPDWRs is appropriate, once the
final IRIS assessment is available.
Trichloroethylene (TCE) and
Tetrachloroethylene (PCE)
The NPDWR for TCE was published
on July 8, 1987 (52 FR 25690, USEPA,
1987) and the NPDWR for PCE was
published on January 30, 1991 (56 FR
PO 00000
Frm 00047
Fmt 4700
Sfmt 4700
59637
3526, USEPA, 1991). Both TCE and PCE
are classified as carcinogens and have
MCLGs and MCLs of zero and 5 mg/L,
respectively. The MCLs were based on
analytical feasibility at the time of rule
promulgation. TCE and PCE were both
listed as candidates for revision in SixYear Review 2, based on updated
analytical feasibility, treatment, and
occurrence information.
In 2011, EPA announced plans to
address a group of regulated and
unregulated carcinogenic volatile
organic contaminants (cVOCs) in a
single regulatory effort. The eight
regulated contaminants that were
evaluated for the cVOCs group
regulation included benzene, carbon
tetrachloride, 1,2-dichloroethane, 1,2dichloropropane, dichloromethane,
PCE, TCE, and vinyl chloride. In SixYear Review 3, these contaminants were
categorized under recent, ongoing, or
planned regulatory action and were not
reviewed. The cVOC group regulation
was not promulgated, as a result these
eight contaminants were reviewed again
during Six-Year Review 4. EPA has
determined that TCE and PCE are no
longer candidates for revision at this
time based on updated information.
In Six-Year Review 2, EPA assessed
analytical information that supported
reducing the PQL and evaluated
occurrence for TCE and PCE at 0.5 mg/
L. As shown in Tables 5 and 6 of this
document, EPA identified information
in Six-Year Review 4 that again
supported assessing occurrence at that
level. The average TCE concentration
exceeded 0.5 mg/L in 297 systems,
representing 0.57 percent of the systems
assessed nationwide and serving
approximately 13 million people.
Similarly, the average PCE
concentration exceeded 0.5 mg/L in 432
systems, which represent 0.83 percent
of the approximately 50,000 PWSs
assessed nationwide and serve
approximately 16 million people. These
occurrence results are consistent with
the Six-Year Review 2 estimates (75 FR
15500, March 29, 2010, USEPA, 2010a).
The most recent final IRIS
assessments for TCE (USEPA, 2011) and
PCE (USEPA, 2012) were completed
after the Six-Year Review 2 results were
published and have been selected as the
health assessments relevant to chronic
toxicity for TCE and PCE in Six-Year
Review 4 (USEPA, 2024f). The updated
IRIS assessments maintained the
classification of ‘‘carcinogenic to
humans,’’ and therefore do not support
a change to the MCLGs of zero for either
TCE or PCE. Based on the Six-Year
Review 4 occurrence estimates
described above, EPA considered if
there was a potential for an increase in
E:\FR\FM\23JYR1.SGM
23JYR1
59638
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
human health protection at the lower
identified level. To evaluate this
potential, EPA examined the cancer risk
level associated with the current MCLs
(5 mg/L) and the screening level (0.5 mg/
L) using updated occurrence and health
effects information from Six-Year
Review 4. The cancer risk levels at the
current MCLs for TCE and PCE are 1 ×
10¥5 (USEPA, 2011) and 3.0 × 10¥7
(USEPA, 2012), respectively. These
cancer risk levels correspond to excess
lifetime cancer cases of 10 and 0.3 cases
per million people, respectively. At the
screening level of 0.5 mg/L, the risk per
million people would be 1 case for TCE
and 0.03 cases for PCE. The implied
number of baseline cancer cases over a
70-year exposure period is unlikely to
exceed 120 total cases for TCE and 5
total cases for PCE. This corresponds to
annual averages of 1.7 and 0.07 cases for
TCE and PCE, respectively. This new
information identified since Six-Year
Review 2 indicates that revising the
MCLs for either TCE or PCE would
result in relatively small health risk
reductions among the exposed
population and would divert significant
resources from other planned and
ongoing work. Therefore, EPA has
determined that TCE and PCE are
considered ‘‘low priority’’ and are no
longer candidates for revision.
ddrumheller on DSK120RN23PROD with RULES1
C. Microbial Contaminants Regulations
As discussed in section III of this
document, the initial review branch of
the review protocol identifies NPDWRs
that have recently been recently
competed or are being reviewed in
ongoing or pending regulatory actions.
Excluding such contaminants from a
more detailed review in the Six-Year
Review 4 prevents duplicative Agency
efforts. Based on the initial review and
considering the ongoing rulemaking
activities for the Microbial and
Disinfection Byproduct Rules, EPA did
not perform a more detailed review for
the Surface Water Treatment Rule
(SWTR), the Interim Enhanced Surface
Water Treatment Rule (IESWTR), the
Long-Term 1 Enhanced Surface Water
Treatment Rule (LT1ESWTR), and the
Stage 1 and Stage 2 Disinfectants and
Disinfection Byproducts Rules. The
following microbial contaminant
regulations were subject to a more
detailed review for the Six-Year Review
4:
• Revised Total Coliform Rule (RTCR)
• Long Term 2 Enhanced Surface Water
Treatment Rule (LT2)
• Ground Water Rule (GWR)
• Aircraft Drinking Water Rule (ADWR)
• Filter Backwash Recycling Rule
(FBRR)
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
Background information on each of
the microbial contaminant regulations is
presented in the subsequent sections.
EPA is conducting its first detailed
review of the RTCR and the ADWR as
part of the Six-Year Review. The RTCR
and the ADWR were excluded from a
detailed review in Six Year Review 3
because they were promulgated in 2013
and 2009, respectively.
These microbial contaminants
regulations establish treatment
technique (TT) requirements in lieu of
MCLs, except in the RTCR, EPA also
established an MCL for Escherichia coli
(E. coli) and TT requirements for total
coliform. In accordance with the SixYear Review Protocol, during the sixyear review process, EPA assesses
whether new health risk, analytical
methods, or treatment information
indicate possible TT revision. For the
RTCR, the regulatory review determines
whether new information indicates
potential revision to the MCL for E. coli.
The elements of the RTCR, LT2, GWR,
and ADWR regulations that were
reviewed for Six-Year Review 4 were:
health effects, analytical feasibility,
occurrence and exposure, and treatment
feasibility. For the RTCR, LT2, GWR,
and ADWR regulations, the EPA did not
find any new relevant information as it
relates to analytical feasibility. For all
the other elements reviewed a summary
of the findings is included in the
subsequent sections. In addition,
detailed information about the review is
provided in the ‘‘Six-Year Review 4
Technical Support Document for
Microbial Contaminant Regulations’’
(USEPA, 2024m).
At this time, none of the reviewed
microbial contaminant rules are being
identified as a candidate for regulatory
revision.
1. Revised Total Coliform Rule
Background
EPA promulgated the Revised Total
Coliform Rule (RTCR), a revision to the
Total Coliform Rule, on February 13,
2013 (78 FR 10269, USEPA, 2013). The
Total Coliform Rule (TCR) was
promulgated on June 29, 1989 (54 FR
27544, USEPA, 1989). The purpose of
the revision was to increase public
health protection through the reduction
of potential entry pathways for fecal
contamination into distribution systems.
The TCR required all public water
systems (PWSs) to monitor for the
presence of total coliforms and
Escherichia coli (E. coli)) in the
distribution system at a frequency
dependent on the size (population
served by) of the system. Under the
TCR, a maximum contaminant level
PO 00000
Frm 00048
Fmt 4700
Sfmt 4700
(MCL) was established based on the
presence or absence of total coliforms
with the intent to address
contamination that could enter into
distribution systems. The RTCR revised
the TCR to eliminate the MCL for total
coliforms and established an MCLG and
MCL for E. coli of zero. The RTCR also
requires PWSs that have an indication
of coliform contamination (e.g., as a
result of total coliform positive samples,
E. coli MCL violations or performance
failure) to find and assess the problem,
identify sanitary defects and take
corrective action. There are two levels of
assessments (i.e., Level 1 and Level 2)
based on the severity or frequency of the
problem.
Summary of Review Results
Information available for national
occurrence and exposure indicates that
both routine total coliform and E. coli
positive rates have decreased after the
implementation of RTCR. EPA
concludes that no regulatory revisions
to the RTCR are appropriate at this time
based on the review of available
information.
Health Effects
Collier et al. (2021) estimated the
collective U.S. disease burden
attributable to over a dozen waterborne
illnesses from infectious pathogens
found in the distribution system
(vibriosis, campylobacteriosis,
cryptosporidiosis, giardiasis,
Legionnaire’s disease, salmonellosis,
shigellosis, infections by nontuberculous mycobacteria (NTM),
norovirus, Shiga-toxin-producing E.
coli, otitis externa, pneumonia, and
septicemia). These researchers
estimated the total disease burden at
approximately 7.15 million cases
annually, with an estimated 118,000
hospitalizations and 6,630 deaths. In
this analysis, waterborne disease is
understood to include gastrointestinal,
respiratory, and systemic disease
attributable to both drinking-water and
non-drinking-water exposure. From
further evaluation of this study’s cases,
Gerdes et al. (2023) determined 1.13
million of these illnesses were
attributable to drinking water.
According to the estimates presented in
these studies, the opportunistic
pathogens (Legionella, Nontuberculous
Mycobacteria (NTM), and
Pseudomonas) impose a greater public
health burden than the fecal pathogens.
Of the estimated 7.15 million infectious
waterborne illnesses in 2014 in the
United States, drinking water exposure
caused 40 percent of hospitalizations
and 50 percent of deaths.
E:\FR\FM\23JYR1.SGM
23JYR1
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
Occurrence and Exposure
To evaluate potential pathogenic
contamination in distribution systems
EPA analyzed national compliance
monitoring data from the SYR 4 ICR
dataset (USEPA, 2019. EPA assessed the
trends that may be associated with the
implementation of the RTCR and found
a statistically significant decline for
total coliform positive results from years
of 2014–2015 to 2018–2019 (i.e., before
and after the implementation of RTCR
respectively). The result suggests that
the presence of these indicator
organisms in the distribution system
was declining. The trend of declining
positive total coliform results was
observed across different types of public
water systems, water sources (ground
water versus surface water), and system
sizes (small versus large). With respect
to the fecal contamination indicator E.
coli, the observed decreasing trend was
not supported by a statistical test of
significance. EPA also found that the
absolute number of E. coli positives
were low, suggesting that the treatment
techniques are effective (USEPA,
2024m).
ddrumheller on DSK120RN23PROD with RULES1
Treatment Feasibility
In this section as part of Six-Year
Review process, EPA evaluated new
information about tools and treatment
techniques. Since the major treatment
technique requirements under the RTCR
are assessments followed by corrective
actions (if total coliform and/or E. coli
are detected), EPA evaluated the
effectiveness of such requirements by
comparing total coliform and E. coli
positive rates after completion of either
Level 1 or Level 2 assessments (USEPA,
2024m).
EPA found about an 80 percent
decrease in both routine total coliform
and E. coli positive rates, two months
after completion of RTCR assessments
for systems having a monthly
monitoring schedule.
These analytical results and newly
compiled information suggest that the
‘‘find and fix’’ approach prescribed
under the provisions of assessments and
corrective action within RTCR appears
to work as intended for reducing the
microbial occurrence in distribution
systems and may be improving public
health protection from microbial risks
(as indicated by a substantial drop of the
total coliform and E. coli positive rates
following completion of corrective
actions to respond to assessments).
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
2. Long Term 2 Enhanced Surface Water
Treatment Rule
Background
EPA promulgated the Long Term 2
Enhanced Surface Water Treatment
Rule, hereafter referred to as ‘‘LT2’’, on
January 5, 2006 (71 FR 654, USEPA,
2006a). The LT2 applies to all PWSs
that use surface water or ground water
under the direct influence of surface
water. The LT2 builds upon the
IESWTR and the LT1 by improving
control of microbial pathogens and by
focusing on systems with elevated
Cryptosporidium contamination risk.
The purposes of the LT2 are to protect
public health from illness arising from
exposure to Cryptosporidium and other
microbial pathogens in drinking water
and to prevent significant increases in
risks that might occur when systems
implement drinking water disinfection
byproduct rules.
Key provisions in the LT2 include:
source water monitoring for
Cryptosporidium (with a screening
procedure to reduce monitoring costs
for small systems); risk-targeted
Cryptosporidium treatment by filtered
systems with the highest source water
Cryptosporidium levels; inactivation of
Cryptosporidium by all unfiltered
systems; criteria for the use of
Cryptosporidium treatment and control
processes; and covering or treating
uncovered finished water storage
facilities.
The LT2 requires PWSs using surface
water or ground water under the direct
influence of surface water to monitor
their source waters for Cryptosporidium
and/or E. coli to identify additional
treatment requirements. PWSs must
monitor their source water (i.e., the
influent water entering the treatment
plant) over two different timeframes
(defined as Round 1 and Round 2) to
determine the occurrence of
Cryptosporidium. Monitoring results
determine the extent of
Cryptosporidium treatment
requirements under the LT2. According
to the LT2 rule requirements, all PWSs
were to complete Round 2 by 2021. To
reduce monitoring costs, small filtered
PWSs (serving fewer than 10,000
people) which initially monitor for E.
coli for one year as a screening analysis,
are required to monitor for
Cryptosporidium only if their E. coli
levels exceed specified trigger values.
Small filtered PWSs that exceed the E.
coli trigger, as well as small unfiltered
PWSs, must monitor for
Cryptosporidium for one or two years,
depending on the sampling frequency.
The LT2 also requires all unfiltered
PWSs to provide at least 2 to 3-log (i.e.,
PO 00000
Frm 00049
Fmt 4700
Sfmt 4700
59639
99 to 99.9 percent) inactivation of
Cryptosporidium. Further, under the
LT2, unfiltered PWSs must achieve their
overall inactivation requirements
(including Giardia lamblia and virus
inactivation as established by earlier
regulations) using a minimum of two
disinfectants.
Under the LT2, PWSs with uncovered
finished water reservoirs (UCFWR) must
either cover the storage facility or treat
the water leaving the storage facility to
achieve inactivation and/or removal of
4-log virus, 3-log Giardia lamblia and 2log Cryptosporidium using a protocol
approved by the state (USEPA, 2006a).
Most finished water reservoirs for
surface water systems are covered. All
PWSs with UCFWRs are under
administrative orders or compliance
agreements to cover or treat their
UCFWR.
Summary of Review Results
From a review of the literature on
Cryptosporidium health effects, EPA
concludes that there is no new health
information to suggest a need to modify
the LT2. In addition, EPA determined
that no regulatory revisions to the
microbial toolbox options are
appropriate at this time. During SixYear Review 4, EPA did not consider
disinfection profiling information since
EPA is evaluating overall filtration and
disinfection requirements in the SWTRs
as part of the on-going consideration of
potential revisions to the MDBP rules.
For more information regarding EPA’s
review of treatment feasibility see the
‘‘Six-Year Review 4 Technical Support
Document for Microbial Contaminant
Regulations’’ (USEPA, 2024m).
Health Effects
Since 1995, cryptosporidiosis has
been a nationally notifiable disease,
meaning healthcare providers and
laboratories that diagnose cases of
laboratory-confirmed cryptosporidiosis
are required to report cases to their local
or state health departments, which in
turn report the cases to CDC. Since
2012, there have been four reported
outbreaks of cryptosporidiosis from
public water systems to CDC. The four
outbreaks together resulted in a total of
201 recorded illnesses, 2
hospitalizations, and no deaths (CDC,
2022). Although cryptosporidiosis is a
nationally notifiable disease, additional
outbreaks may go unreported to CDC or
may have been recorded as of uncertain
causes. In addition, since CDC’s
National Outbreak Reporting System is
specifically focused on outbreaks, it
does not capture rates of endemic
disease of cryptosporidiosis from
drinking water.
E:\FR\FM\23JYR1.SGM
23JYR1
59640
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
ddrumheller on DSK120RN23PROD with RULES1
Occurrence and Exposure
Based on the LT2 source water
monitoring results, filtered systems
were classified in one of four risk
categories (Bins 1–4) to determine
additional treatment needed. Systems in
Bin 1 are not required to provide
additional Cryptosporidium treatment.
Systems in Bins 2–4 must achieve 1.0–
2.5 log of treatment (i.e., 90 to 99.7
percent reduction for Cryptosporidium)
over and above that provided by
conventional treatment, depending on
the Cryptosporidium concentrations.
Filtered PWSs must meet the additional
Cryptosporidium treatment
requirements in Bins 2, 3, or 4 by
selecting one or more technologies from
the microbial toolbox to ensure source
water protection and management, and/
or Cryptosporidium removal or
inactivation. All unfiltered water
systems must provide at least 99 or 99.9
percent (2 or 3-log) inactivation of
Cryptosporidium, depending on their
monitoring results. All filtered systems
that provide 5.5 log treatment for
Cryptosporidium are exempt from
monitoring and subsequent bin
classification.
Six years after the initial bin
classification following a first round of
monitoring, filtered systems were
required to conduct a second round of
monitoring. Round 2 monitoring began
in 2015. Round 2 monitoring was
implemented to understand year-to-year
variability for occurrence of
Cryptosporidium. The difference
observed between occurrence at the
time of the ICR Supplemental Surveys
and the LT2 Round 1 monitoring
indicates year-to-year variability
(USEPA, 2017a).
Limited occurrence data for
Cryptosporidium was available to EPA
in response to the SYR 4 ICR since
fewer than 1 percent of the
Cryptosporidium monitoring records
provided actual concentration levels
with units of oocysts/L; however, the
data about system binning for about 300
PWSs serving populations larger than
10,000 was provided. Those data
indicate that the percentage of PWSs
potentially moving to an ‘‘action bin’’
based on Round 2 monitoring would not
be substantially higher than the
percentage estimated based on modeling
conducted during the LT2 review
included as part of the Six-Year Review
3, thus suggesting no change to the
review decision made under Six-Year
Review 3.
Treatment Feasibility
The LT2 includes a variety of
treatment and control options,
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
collectively termed the ‘‘microbial
toolbox,’’ that PWSs can implement to
comply with the LT2’s additional
Cryptosporidium treatment
requirements. Most options in the
microbial toolbox carry prescribed
credits toward Cryptosporidium
treatment and control requirements. The
LT2 Toolbox Guidance Manual (USEPA,
2010e) provides guidance on how to
apply the toolbox options.
For the Six-Year Review 4, EPA
reviewed additional research into the
relationship between ultraviolet light
(UV) dose and log inactivation. Some
studies showed the same log
inactivation at UV doses lower than
those reported in previous EPA
guidance, and other studies showed log
inactivation at UV doses higher than
those contained in the guidance. Since
there is not a consensus of log
inactivation at levels significantly lower
than EPA prior published guidance,
EPA concludes that the new information
does not support changes to the UV
dose table.
EPA also reviewed new information
pertaining to technologies, which have
not been included in the existing LT2
toolbox guidance manual, and which
may be effective for the removal or
inactivation of protozoa including
Cryptosporidium. In addition, EPA also
reviewed new technologies that water
systems may be employing to improve
treatment performance for complying
with the MDBP rules, e.g., turbo
coagulation and powdered activated
carbon. Initiatives by states and EPA’s
Area Wide Optimization Program were
evaluated as well. EPA found that this
new information appears insufficient to
develop quantification criteria for
inactivation and removal credit for
Cryptosporidium.
3. Ground Water Rule
Background
EPA promulgated the Ground Water
Rule (GWR) in 2006 (71 FR 65574,
USEPA, 2006b) to provide protection
against microbial pathogens in PWSs
using ground water sources. The rule
establishes a risk-based approach to
target undisinfected ground water
systems that are vulnerable to fecal
contamination. In addition to the
protection provided by the RTCR and
GWR monitoring requirements, systems
that do not disinfect are also protected
by the sanitary survey provisions of the
GWR and the treatment technique
provisions of the RTCR.
The GWR required compliance
beginning December 1, 2009. Since the
triggered source water monitoring
provision was built upon the
PO 00000
Frm 00050
Fmt 4700
Sfmt 4700
compliance monitoring results of total
coliform and E. coli under the TCR and
later RTCR, implementation of the GWR
was not yet completed for the period of
time covered by the Six-Year Review 3
ICR (2006–2011). The RTCR was
promulgated in 2013 and became
effective on April 1, 2016. EPA expected
that implementation of the RTCR might
impact the percent of ground water
systems that would be triggered into
source water monitoring and taking any
corrective actions under the GWR.
Therefore, the effects of the GWR and
the RTCR implementation in addressing
vulnerable ground water systems were
not reviewed during the Six-Year
Review 3 process.
Summary of Review Results
The information considered during
this review suggest that microbial
pathogens have been detected in
untreated ground water samples which
show no presence of fecal indicators,
however these studies are limited in
quantity and the prevalence of endemic
disease from microbial contamination of
untreated ground water cannot be well
characterized with the available
information (USEPA, 2024m).
Additional and more robust studies are
needed to further understand the
magnitude of the issue. EPA concludes
that no regulatory revisions to the GWR
are appropriate at this time.
Health Effects
Waterborne pathogens can cause mild
to severe illnesses (Wallender et al.,
2014). These illnesses may include;
acute gastrointestinal illness (AGI) with
diarrhea, abdominal pain/discomfort,
nausea, vomiting, conjunctivitis, aseptic
meningitis, and hand-foot-and-mouth
disease. Infections from some
waterborne pathogens (e.g.,
Campylobacter) may cause long-term
implications, such as reactive arthritis,
Guillain-Barré syndrome, and irritable
bowel syndrome (Keithlin et al., 2014).
Other more severe illnesses include
hemolytic uremic syndrome (HUS)
(kidney failure), hepatitis, and bloody
diarrhea (WHO, 2004).
Some studies have indicated that
waterborne pathogens such as
adenovirus, enteroviruses, hepatitis A,
norovirus, rotavirus, Salmonella,
Giardia, Cryptosporidium, and Shigella
have been found in untreated ground
water samples (Borchardt et al., 2012;
Wallender et al., 2014; Stokdyk et al.,
2020).
Human enteric viruses have been
detected in drinking water free of
bacterial indicators, such as total
coliform. With total coliform detections
rates similar to the average rate for
E:\FR\FM\23JYR1.SGM
23JYR1
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
ddrumheller on DSK120RN23PROD with RULES1
undisinfected community PWSs in the
U.S, Borchardt et al. (2012) estimated a
six to 22 percent attributable risk for
enteric illness from viruses present in
the communities’ drinking water. In
another study, Burch et al. (2022) found
that noncommunity wells had higher
infection risk than community wells.
Burch et al. (2022) found the annual risk
was relatively high for all pathogens
combined in the study, while the
average daily doses for individual
pathogens were low, indicating that
significant risk results from sporadic
pathogen exposure. Studies by Fout et
al. (2017) and Stokdyk et al. (2020)
found that total coliform (and other
indicators like E. coli, somatic phage,
HF183, and Bacteroidales-like HumM2)
tend to have high specificity, meaning
that absence of the indicator provides
relatively strong assurance that water is
free of viral and other pathogens, but
also have low sensitivity, meaning that
presence of the indicator does not
necessarily predict presence of
pathogens.
Occurrence and Exposure
Similar to the RTCR, EPA examined
the national compliance monitoring
data collected for the Six-Year Review 4
to understand how total coliform and E.
coli, indicators of contamination
behaved before and after
implementation of the GWR, as well as
understanding how level of
contamination for high risk
undisinfected ground water systems
have changed.
As noted, GWR monitoring is based
on initial monitoring under the RTCR. If
a system has a positive total coliform
sample (based on routine coliform
monitoring under the RTCR), the system
must test that sample for the presence
of E. coli. Under the GWR, ground water
systems that do not provide at least 4log treatment of viruses and are notified
of a routine positive total coliform
sample collected under RTCR must
collect and analyze at least one source
water sample for E. coli or other fecal
indicators from each ground water
source (well) within 24 hours. If the
triggered source water sample has a
positive for E. coli the ground water
systems must take corrective action.
EPA conducted a distribution system
total coliform/E. coli data exploration
and analysis effort to identify findings
that could inform the risk reduction of
the fully implemented GWR, as well as
characterize high risk systems.
The national average total coliform
and E. coli rates (i.e., total number of
positives divided by total number of
samples) before and after
implementation of the GWR were
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
calculated using Six-Year Review 3 and
Six-Year Review 4 datasets. The
analytical results were grouped by
system sizes and disinfection status (i.e.,
disinfecting versus and undisinfected).
The period of analysis was from 2007–
2008 (before the GWR was
implemented) to 2014–2015 (after the
completed implementation of the first
round of sanitary surveys under the
GWR). The total coliform rates across
different system categories decreased,
suggesting that there may be less
pathogenic contamination pathways and
so potentially less microbial exposure,
corresponding to the period when the
GWR was being implemented. This
downward change is supported by a
statistical significance test. The
declining count of the fecal
contamination indicator, E. coli was not
supported by a test of statistical
significance. Yet numbers of E. coli
positives were consistently low, which
may indicate low exposure to fecal
contamination.
EPA performed a more specific
analysis using a statistical model
focused on the most vulnerable water
systems, the undisinfected ground water
systems. EPA conducted statistical
modeling focused on examination of
total coliform levels in small ground
water systems to account for their
infrequent sampling and relatively low
level of monitoring observations
compared to larger systems that monitor
more frequently.
There are approximately 45,000
undisinfected ground water systems
associated with total coliform records
collected and less than 1 percent
population among the population
served by the public community water
systems in the U.S. (based on SYR 4 ICR
data). Most undisinfected ground water
systems serve small permanent
populations or transient populations.
EPA found that the smallest systems
(serving a population fewer than 1,001)
have higher median total coliform rates
than undisinfected larger systems. In
addition, the analysis indicates that
median occurrence rates for many
undisinfected transient systems may
have fallen, from four to three percent
total coliform detection rate from 2011
to 2019. Another finding from the
statistical modeling is that the number
of non-community systems that have
high total coliform detections in the
systems serving fewer than 1,001 people
has remained roughly the same, about
7,000 undisinfected ground water
systems, when running a comparison
using Six-Year Review 3 and Six-Year
Review 4 ICR data with a threshold of
five percent rate of total coliform
positive detections, which is the
PO 00000
Frm 00051
Fmt 4700
Sfmt 4700
59641
threshold that triggers a Level 1
Assessment in the RTCR. For statistical
analysis of E. coli detection rates, there
was not sufficient data to make
estimates of averages and numbers of
systems exceeding high levels.
Two implications of these modelling
results should be noted as it relates to
estimating potential exposure and
occurrence. One is that the noncommunity systems serving fewer than
1,001 have total coliform positive rates
around two to four percent, while a
study of 14 community systems served
by untreated ground water in Wisconsin
found that a total coliform positive rate
of 2.3 percent was associated AGI
burden (Borchardt et al, 2012). EPA
concludes, however, that studies
indicating microbial disease burden at
total coliform positive levels found in
high-risk systems are limited in number
as mentioned in the Health Effects
section, as well as in geographic scope.
Another implication from the results of
this statistical analysis is that the
remaining systems with very high total
coliform rates could suggest compliance
challenges among small ground water
systems.
In addition to evaluating trends with
indicators under RTCR to evaluate
protection for vulnerable ground water
systems, EPA also considered the results
from the GWR requirement for triggered
source water sampling. The sample
results indicate that there is a small
percent of positive source water E. coli
detections ranging from 0.76 percent to
1.99 percent of E. coli samples for noncommunity systems which are primarily
undisinfected systems, and 250 out of
270 of source water E. coli detections
were associated with undisinfected
systems serving fewer than 500 people.
The other fecal indicators, coliphage
and enterococci were used very
infrequently, and data was insufficient
to evaluate. Low incidence of fecal
indicators may indicate low exposure to
fecal contamination among
undisinfected ground water systems.
Treatment Feasibility
Per treatment technique requirements
under the GWR, there are two scenarios
that trigger ground water systems to take
corrective actions: (1) positive results of
the triggered source water monitoring,
and (2) significant deficiencies found
during Sanitary Survey (EPA was not
able to assess sanitary surveys directly
given data limitations). EPA evaluated
whether treatment was improving under
the GWR by using the RTCR occurrence
analysis data to consider total coliform
rates before and after the GWR was
implemented.
E:\FR\FM\23JYR1.SGM
23JYR1
ddrumheller on DSK120RN23PROD with RULES1
59642
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
EPA developed a systematic approach
to identify disinfection status of ground
water systems for each of the years
included in the Six-Year Review ICR
datasets and found that the percentage
of ground water systems that were
disinfecting had increased consistently
from 2007–2008 (before the GWR was
implemented) to 2014–2015. This
finding of an increasing number of
systems disinfecting could be
attributable to systems taking corrective
actions to address positive results after
triggered source water monitoring. The
analytical results presented in the ‘‘SixYear Review 4 Technical Support
Document for Microbial Contaminant
Regulations’’ (USEPA, 2024m) also
indicate that disinfecting ground water
systems had substantially lower total
coliform positive rates than
undisinfected ground water systems. In
addition, EPA also observed that the
total coliform positive rates decreased
after completion of the first round of
sanitary surveys under the GWR among
ground water systems.
onboard drinking water, as well as selfinspections of each aircraft water system
and immediate notification of
passengers and crew when violations or
specific situations occur.
4. Aircraft Drinking Water Rule
Health Effects
Limited new literature is available on
the presence of microbial pathogens in
aircraft drinking water. Handschuh et al.
(2015) found that long-haul flights were
significantly poorer in terms of
microbial water quality than short haul
flights. A follow-up study by
Handschuh et al. (2017) demonstrated
that there is a diversity of
microorganisms within the aircraft
drinking water supply chain.
Other studies have also found
microbial contaminants present in
aircraft drinking water, including
Pseudomonas aeruginosa, enterococci,
clostridia, and Salmonella (WHO, 2009;
Schaeffer et al., 2012). Tracking an
illness back to contaminated water
served on an aircraft presents a
technical challenge. Most disease
incubation periods are longer than the
duration of a flight, and even if it is
possible to determine that a disease was
incurred in air travel, it may be difficult
to determine if the route of transmission
was from beverages, food, or close
proximity of people, and to determine
whether transmission happened on
board the aircraft or at an air terminal.
Background
EPA promulgated the Aircraft
Drinking Water Rule (ADWR) on
October 19, 2009 (74 FR 53590, USEPA,
2009b). The primary purpose of the
ADWR is to ensure that safe and reliable
drinking water is provided to aircraft
passengers and crew. This entails
providing air carriers with a feasible
way to comply with SDWA and
NPDWRs. The existing NPDWRs were
designed for traditional, stationary
public water systems not mobile aircraft
water systems that are operationally
different. For example, aircraft fly to
multiple destinations throughout the
course of any given day and may board
drinking water from sources at any of
these destinations. Aircraft board water
from airport watering points via
temporary connections. Aircraft
drinking water safety depends on a
number of factors including the quality
of the water that is boarded from these
multiple sources, the care used to board
the water, and the operation and
maintenance of the onboard water
system and the water transfer
equipment.
The ADWR’s provisions protect
against disease-causing microbiological
contaminants through the required
development and implementation of
aircraft water system operations and
maintenance plans. The ADWR’s
provisions include: routine disinfection
and flushing of the water system, air
carrier training requirements for key
personnel, and periodic sampling of the
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
Summary of Review Results
The ADWR is a unique rule within
the context of the SDWA. This rule
applies only to aircraft engaged in
interstate commerce with onboard
systems that provide water for human
consumption through pipes. These
aircraft water systems board finished
water for human consumption and
regularly serve an average of at least
twenty-five individuals daily, at least 60
days out of the year. Human
consumption includes water for
drinking, hand washing, food
preparation, and oral hygiene. From a
review of available technical
information within the scope of the
review, EPA concludes that there is no
new information to suggest that
regulatory revisions to the ADWR are
appropriate at this time.
Occurrence and Exposure
The Aircraft Reporting and
Compliance System (ARCS) is used to
facilitate the reporting of aircraft water
system data under the ADWR. Air
carriers subject to the ADWR must
report to EPA about their inventory of
aircraft water system fleet; the date the
operations and maintenance plan was
developed; the date the coliform
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
sampling plan was developed; the date
the aircraft water system sampling
plan(s) was incorporated into the
aircraft water system Operations and
Maintenance plan; the date the
Operations and Maintenance plan(s)
was incorporated into the U.S. Federal
Aviation Administration (FAA)
accepted air carrier Operation and
Maintenance program; the frequency for
routine disinfection and flushing, and
the corresponding routine total coliform
sampling frequency; and the date for
routine disinfection and flushing,
routine coliform sampling dates and
results, and corrective actions (when
applicable).
For Six-Year Review 4, EPA
downloaded and reviewed compliance
monitoring data available in ARCS as of
May 2021. Approximately 140,000
records of aircraft water systems
compliance monitoring data for total
coliform and E. coli samples were
available in ARCS from February 2011
through May 2021, including results
reported for more than 70 different
makes/models of aircraft. These results
were used to characterize the positivity
rates of total coliform and E. coli in
aircraft water systems on an annual
basis for the years that data were
available (2011–2021) and for the subset
of years 2012 through 2019. This
approach removes potentially
confounding considerations associated
with evaluating data for calendar year
2020 when a large number of aircraft
PWS were inactive due to COVID–19, as
well as years 2011 and 2021 for which
the ARCS data evaluated represents
partial years.
Monitoring data broken down by year
for the years 2012–2019 shows an
average annual total coliform positivity
rate of 5.46 percent, with a median of
5.63 percent, a minimum of 3.76 percent
and a maximum of 7.03 percent. The
total coliform positivity rate decreased
on an annual basis from 2012–2019. The
average E. coli positivity rate was 0.26
percent, and the median rate was also
0.26 percent, with a minimum of 0.17
percent and a maximum of 0.33 percent.
The E. coli positivity rate also decreased
on an annual basis.
Treatment Feasibility
Under the ADWR, air carriers
routinely disinfect and flush aircraft
water systems at the frequency
recommended by the water system
manufacturer or, if not specified by the
manufacturer, they may choose from
one of four options. If corrective
disinfection and flushing is chosen or
required, air carriers follow the
procedures in their O&M plans.
Unscheduled flight disruptions to
E:\FR\FM\23JYR1.SGM
23JYR1
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
perform corrective disinfection and
flushing can be minimized by shutting
off the water or preventing the flow of
water to the taps. Before allowing
unrestricted access to the aircraft water
system, a complete set of follow-up
samples must be collected and
submitted for analysis after the
disinfection and flushing event if
triggered by a total coliform-positive
sample and must be reported as total
coliform-negative if triggered by an E.
coli-positive sample. One study was
identified that examined the
effectiveness of disinfection and
flushing procedures to prevent coliform
persistence in aircraft water systems
(Szabo et al., 2019). That study showed
that coliforms were not persistent on the
aircraft plumbing surfaces, and
coliforms were not detected after
disinfection and flushing. However, it
noted an exception for the aerator
installed in the lavatory faucet which
was coliform positive after disinfection
with ozone and mixed oxidants;
disinfection with glycolic acid and
quaternary ammonia showed no
detectable coliforms on aerators after 30
minutes of soaking in the disinfectants.
Each aircraft water system must be
inspected by the air carrier at least every
5 years according to the procedures in
their O&M plans. At a minimum, the
self-inspection procedures for an aircraft
water system must include inspection of
the storage tank, distribution system,
supplemental treatment, fixtures,
valves, and backflow prevention
devices. Any deficiencies detected must
be addressed, and any deficiency that is
unresolved within 90 days of
identification of the deficiency must be
reported to EPA.
ddrumheller on DSK120RN23PROD with RULES1
5. Filter Backwash Recycling Rule
EPA promulgated the Filter Backwash
Recycling Rule (FBRR) on June 8, 2001
(66 FR 31086, USEPA, 2001a). The rule
aimed to increase public health
protection by addressing microbial
contaminant risks associated with filter
backwash recycling practices. The rule
required certain systems to return
recycled filter backwash water, sludge
thickener supernatant, and liquids from
dewatering processes to a location in the
system such that all filtration processes
of a system are employed, or at an
alternate location if approved by the
State. In addition, the rule required
systems that employ conventional
filtration or direct filtration to notify
States of their recycling practices by
June 8, 2004, and after then to keep and
retain records on file about their recycle
flows for subsequent review and
evaluation by the State. There are no
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
ongoing monitoring requirements
associated with the FBBR.
EPA reviewed available State data
collected under the ICR; however, the
EPA did not identify any new and
relevant information that would
indicate that revisions to the NPDWR at
this time are appropriate.
VI. References
ATSDR. 2003. Toxicological Profile for
Selenium. Atlanta, GA: U.S. Department
of Health and Human Services, Public
Health Service, Agency for Toxic
Substances and Disease Registry
(ATSDR). https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/2990677
ATSDR. 2006. Toxicological Profile for
Dichlorobenzenes. Atlanta, GA: U.S.
Department of Health and Human
Services, Public Health Service, Agency
for Toxic Substances and Disease
Registry (ATSDR). https://hero.epa.gov/
hero/index.cfm/reference/details/
reference_id/5160103
ATSDR. 2012. Toxicological Profile for
Cadmium. Atlanta (GA): U.S.
Department of Health and Human
Services, Public Health Service, Agency
for Toxic Substances and Disease
Registry (ATSDR). https://hero.epa.gov/
hero/index.cfm/reference/details/
reference_id/2509015
Borchardt, M.A., S.K. Spencer, B.A. Kieke,
Jr., E. Lambertini, and F.J. Loge. 2012.
Viruses in Nondisinfected Drinking
Water from Municipal Wells and
Community Incidence of Acute
Gastrointestinal Illness. Environmental
Health Perspectives, 120(9): 1272–1279.
Burch T.R., J.P. Stokdyk, N. Rice, A.C.
Anderson, J.F. Walsh, S.K. Spencer, A.D.
Firnstahl and M.A. Borchardt. 2022.
Statewide Quantitative Microbial Risk
Assessment for Waterborne Viruses,
Bacteria, and Protozoa in Public Water
Supply Wells in Minnesota.
Environmental Science & Technology.
56(10): 6315–6324.
CalEPA. 2010a. Public Health Goal for
Methoxychlor in Drinking Water. EPA–
HQ–OW–2016–0627–0033. Sacramento,
CA: California Environmental Protection
Agency (CalEPA), Office of
Environmental Health Hazard
Assessment. https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/10489852
CalEPA. 2010b. Public Health Goal for
Styrene in Drinking Water. Sacramento,
CA: California Environmental Protection
Agency (CalEPA), Office of
Environmental Health Hazard
Assessment. https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/10489854
CalEPA. 2016. Public Health Goal for
Antimony in Drinking Water: 2016
Update. Sacramento, CA: California
Environmental Protection Agency
(CalEPA), Office of Environmental
Health Hazard Assessment. https://
hero.epa.gov/hero/index.cfm/reference/
details/reference_id/10489864
PO 00000
Frm 00053
Fmt 4700
Sfmt 4700
59643
Centers for Disease Control and Prevention
(CDC). 2022. National Outbreak
Reporting System Dashboard. Atlanta,
Georgia: U.S. Department of Health and
Human Services, CDC. Accessed
November 2022. Available from URL:
wwwn.cdc.gov/norsdashboard.
Collier, S.A., L. Deng, E.A. Adam, K.M.
Benedict, E.M. Beshearse, A.J.
Blackstock, B.B Bruce, G. Derado, C.
Edens, K.E. Fullerton and J.W. Gargano.
2021. Estimate of burden and direct
healthcare cost of infectious waterborne
disease in the United States. Emerging
Infectious Diseases. 27(1): 140.
Fout, G.S., M.A. Borchardt, B.A. Kieke Jr.,
and M.R. Karim. 2017. Human virus and
microbial indicator occurrence in publicsupply groundwater systems: metaanalysis of 12 international studies.
Hydrogeology Journal. 25(4): 903.
Gerdes, M.E., S. Miko, J.M. Kunz, E.J.
Hannapel, M.C. Hlavsa, M.J. Hughes,
M.J. Stuckey, L.K.F. Watkins, J.R. Cope,
J.S. Yoder, V.R. Hill, and S.A. Collier.
2023. Estimating Waterborne Infectious
Disease Burden by Exposure Route,
United States, 2014. Emerging Infectious
Diseases. 29(7): 1357.
Health Canada. 2014. Guidelines for
Canadian Drinking Water Quality.
Guideline Technical Document. Toluene,
Ethylbenzene and Xylenes. Ottawa,
Ontario: Health Canada. https://
hero.epa.gov/hero/index.cfm/reference/
details/reference_id/3049488
Handschuh, H., J. O’Dwyer, and C.C. Adley.
2015. Bacteria that travel: the quality of
aircraft water. International Journal of
Environmental Research and Public
Health, 12(11): 13938–13955.
Handschuh, H., M.P. Ryan, J. O’Dwyer and C.
C. Adley. 2017. Assessment of the
bacterial diversity of aircraft water:
identification of the frequent fliers. PLoS
One, 12(1): e0170567.
Keithlin, J., J. Sargeant, M.K. Thomas, and A.
Fazil. 2014. Systematic review and metaanalysis of the proportion of
Campylobacter cases that develop
chronic sequelae. BMC Public Health 14:
1–19.
National Drinking Water Advisory
Committee (NDWAC). 2000.
Recommended Guidance for Review of
Existing National Primary Drinking
Water Regulations. November 2000.
National Research Council (NRC). 2006.
Fluoride in drinking-water: A Scientific
Review of EPA’s Standards. The National
Academies Press, Washington, DC.
National Toxicology Program (NTP). 2023.
NTP Board of Scientific Counselors
Working Group Report on the Draft State
of the Science Monograph and the Draft
Meta-Analysis Manuscript on Fluoride.
Research Triangle Park, NC: U.S.
Department of Health and Human
Services, National Institutes of Health,
National Institute of Environmental
Health Sciences, NTP.
Schaeffer, F., K. Tower, and A.S. Weissfeld.
2012. What’s Up with Aircraft Drinking
Water? Clinical Microbiology Newsletter,
34(2): 9–13.
Stokdyk J.P., A.D. Firnstahl, J.F. Walsh, S.K.
Spencer, J.R. de Lambert, A.C. Anderson,
E:\FR\FM\23JYR1.SGM
23JYR1
ddrumheller on DSK120RN23PROD with RULES1
59644
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
L.W. Rezania, B.A. Kieke Jr. and M.A.
Borchardt. 2020. Viral, bacterial, and
protozoan pathogens and fecal markers
in wells supplying groundwater to
public water systems in Minnesota, USA.
Water Research. 178: 115814.
Szabo, J.; M. Rodgers; J. Mistry; J. Steenbock;
and J. Hall. 2019. The effectiveness of
disinfection and flushing procedures to
prevent coliform persistence in aircraft
water systems. Water Supply. 19 (5):
1339–1346. https://doi.org/10.2166/
ws.2018.195.
U.S. Department of Health and Human
Services Federal Panel on Community
Water Fluoridation. 2015. U.S. Public
Health Service Recommendation for
Fluoride Concentration in Drinking
Water for the Prevention of Dental
Caries. Public Health Reports. 2015 Jul–
Aug; 130(4):318–31. doi: 10.1177/
003335491513000408.
USEPA. 1985. National Primary Drinking
Water Regulations; Volatile Synthetic
Organic Chemicals; Final Rule and
Proposed Rule. 50 FR 46880. November
13, 1985.
USEPA. 1986. National Primary and
Secondary Drinking Water Regulations;
Fluoride; Final Rule. 51 FR 11396. April
2, 1986.
USEPA. 1987. National Primary Drinking
Water Regulations; Synthetic Organic
Chemicals; Monitoring for Unregulated
Contaminants; Final Rule. 52 FR 25690.
July 8, 1987.
USEPA 1989. Drinking Water; National
Primary Drinking Water Regulations;
Total Coliforms (including Fecal
Coliforms and E. coli); Final Rule. 54 FR
27544. June 29, 1989.
USEPA. 1991. National Primary Drinking
Water Regulations-Synthetic Organic
Chemicals and Inorganic Chemicals;
Monitoring for Unregulated
Contaminants; National Primary
Drinking Water Regulations
Implementation; National Secondary
Drinking Water Regulations; Final Rule.
56 FR 3526. January 30, 1991.
USEPA. 1992. Drinking Water; National
Primary Drinking Water RegulationsSynthetic Organic Chemicals and
Inorganic Chemicals; National Primary
Drinking Water Regulations
Implementation. 57 FR 31776. July 17,
1992.
USEPA. 1998. Toxicological Review of
Beryllium and Compounds. EPA/635/R–
98/008. Washington, DC: U.S.
Environmental Protection Agency
(USEPA). https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/999207.
USEPA. 2001. Integrated Risk Information
System (IRIS) Chemical Assessment
Summary: Hexachlorocyclopentadiene.
Washington, DC: U.S. Environmental
Protection Agency (USEPA), Office of
Research and Development, National
Center for Environmental Assessment.
https://hero.epa.gov/hero/index.cfm/
reference/details/reference_id/10509468.
USEPA. 2001a. National Primary Drinking
Water Regulations: Filter Backwash
Recycling Rule. 66 FR 31086. June 8,
2001.
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
USEPA. 2002. IRIS Toxicological Review of
1,1-Dichloroethylene in Support of
Summary Information. EPA/635/R02/
002. Washington, DC: U.S.
Environmental Protection Agency
(USEPA), National Center for
Environmental Assessment, Office of
Research and Development. https://
hero.epa.gov/hero/index.cfm/reference/
details/reference_id/10721895.
USEPA. 2003. National Primary Drinking
Water Regulations; Announcement of
Completion of EPA’s Review of Existing
Drinking Water Standards. Notice. 68 FR
42908. July 18, 2003.
USEPA. 2004. Reregistration Eligibility
Decision (RED) for Lindane. Washington,
DC: U.S. Environmental Protection
Agency (USEPA), Office of Prevention,
Pesticides and Toxic Substances. https://
hero.epa.gov/hero/index.cfm/reference/
details/reference_id/10492448.
USEPA. 2005. Toxicological Review of
Barium and Compounds (CAS No. 7440–
39–3) in Support of Summary
Information on the Integrated Risk
Information System (IRIS) (Revised).
EPA/635/R–05/001. Washington, DC:
U.S. Environmental Protection Agency
(USEPA). https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/11311280.
USEPA. 2006a. National Primary Drinking
Water Regulations: Long-Term 2
Enhanced Surface Water Treatment Rule;
Final Rule. 71 FR 654. January 5, 2006.
USEPA. 2006b. National Primary Drinking
Water Regulations: Ground Water Rule;
Final Rule. 71 FR 65574. November 8,
2006.
USEPA. 2007a. Acetochlor/Alachlor: Revised
Cumulative Risk Assessment for the
Chloroacetanilides to Support the
Proposed New Uses on Alachlor and
Acetochlor. Washington, DC: U.S.
Environmental Protection Agency
(USEPA), Office of Prevention,
Pesticides, and Toxic Substances.
https://hero.epa.gov/hero/index.cfm/
reference/details/reference_id/10492629.
USEPA. 2007b. Toxicological Review of
1,1,1-Trichloroethane. EPA/635/R–03/
013. Washington, DC: U.S.
Environmental Protection Agency
(USEPA). https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/3004991.
USEPA. 2008. Carbofuran. HED Revised Risk
Assessment for the Notice of Intent to
Cancel (NOIC). EPA–HQ–OPP–2007–
1088–0034. Washington, DC: U.S.
Environmental Protection Agency
(USEPA), Office of Prevention,
Pesticides, and Toxic Substances.
https://hero.epa.gov/hero/index.cfm/
reference/details/reference_id/10494332.
USEPA. 2009a. Provisional Peer-Reviewed
Toxicity Values for 1,2,4Trichlorobenzene, CASRN 120–82–1.
EPA/690/R–09/065F. Cincinnati, OH:
U.S. Environmental Protection Agency
(USEPA), Office of Research and
Development, National Center for
Environmental Assessment, Superfund
Health Risk Technical Support Center.
https://hero.epa.gov/hero/index.cfm/
reference/details/reference_id/10255709.
PO 00000
Frm 00054
Fmt 4700
Sfmt 4700
USEPA. 2009b. National Primary Drinking
Water Regulations: Drinking Water
Regulations for Aircraft Public Water
Systems. 74 FR 53590. October 19, 2009.
USEPA. 2010a. National Primary Drinking
Water Regulations; Announcement of the
Results of EPA’s Review of Existing
Drinking Water Standards and Request
for Public Comment and/or Information
on Related Issues. 75 FR 15500. March
29, 2010.
USEPA. 2010b. Toxicological Review of
Hydrogen Cyanide and Cyanide Salts.
EPA/635/R–08/016F. Washington, DC:
U.S. Environmental Protection Agency
(USEPA). https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/723657.
U.S. EPA. 2010c. Integrated Risk Information
System (IRIS) Chemical Assessment
Summary: cis-1,2-Dichloroethylene,
CASRN 156–59–2. Washington, DC: U.S.
Environmental Protection Agency
(USEPA), Office of Research and
Development. https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/10493648.
USEPA. 2010d. Fluoride: Dose-Response
Analysis for Non-Cancer Effects. EPA/
820/R–10/019. Washington, DC: U.S.
Environmental Protection Agency
(USEPA), Office of Water. https://
hero.epa.gov/hero/index.cfm/reference/
details/reference_id/10493692.
USEPA. 2010e. Long Term 2 Enhanced
Surface Water Treatment Rule: Toolbox
Guidance Manual. EPA 815–R–09–016.
April 2010. https://www.epa.gov/
dwreginfo/long-term-2-enhancedsurface-water-treatment-rule-documents.
USEPA. 2011. Trichloroethylene; CASRN 79–
01–6. Integrated Risk Information System
(IRIS) Chemical Assessment Summary.
Last Revised September 28, 2011.
Retrieved from https://iris.epa.gov/
ChemicalLanding/&substance_
nmbr=199.
USEPA. 2012. Tetrachloroethylene
(Perchloroethylene); CASRN 127–18–4.
Integrated Risk Information System
(IRIS) Chemical Assessment Summary.
Last Revised February 10, 2012.
Retrieved from https://iris.epa.gov/
ChemicalLanding/&substance_
nmbr=106.
USEPA. 2013. National Primary Drinking
Water Regulations: Revisions to the Total
Coliform Rule; Final Rule. 78 FR 10269.
February 13, 2013.
USEPA. 2015a. Peer Review Handbook 4th
Edition. October 2015. Available online
at: https://www.epa.gov/sites/default/
files/2015-10/documents/epa_peer_
review_handbook_4th_edition_october_
2015.pdf.
USEPA. 2015b. Endothall: Human Health
Risk Assessment in Support of
Registration Review, and the Petition to
Re-Evaluate Tolerances for Livestock,
and Remove the Restriction that
Prohibits Livestock from Drinking
Treated Water. EPA–HQ–OPP–2015–
0591–0012. Washington, DC: U.S.
Environmental Protection Agency
(USEPA), Office of Chemical Safety and
Pollution Prevention, Health Effects
E:\FR\FM\23JYR1.SGM
23JYR1
ddrumheller on DSK120RN23PROD with RULES1
Federal Register / Vol. 89, No. 141 / Tuesday, July 23, 2024 / Rules and Regulations
Division. https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/10494329.
USEPA. 2016. Six-Year Review 3—Health
Effects Assessment for Existing Chemical
and Radionuclide National Primary
Drinking Water Regulations—Summary
Report. EPA 822–R–16–008.
USEPA. 2017a. National Primary Drinking
Water Regulations; Announcement of the
Results of EPA’s Review of Existing
Drinking Water Standards and Request
for Public Comment and/or Information
on Related Issues. 82 FR 3518. January
11, 2017.
USEPA. 2017b. Oxamyl Draft Human Health
Risk Assessment in Support of
Registration Review. Washington, DC:
U.S. Environmental Protection Agency
(USEPA), Office of Chemical Safety and
Pollution Prevention, Health Effects
Division. https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/10532947.
USEPA. 2017c. 2,4–D Revised Human Health
Risk Assessment for Registration Review.
Washington, DC: U.S. Environmental
Protection Agency (USEPA), Office of
Chemical Safety and Pollution
Prevention, Health Effects Division.
https://hero.epa.gov/hero/index.cfm/
reference/details/reference_id/10532862.
USEPA. 2017d. Glyphosate: Draft Human
Health Risk Assessment in Support of
Registration Review. EPA–HQ–OPP–
2009–0361–0068. Washington, DC: U.S.
Environmental Protection Agency
(USEPA), Office of Chemical Safety and
Pollution Prevention. https://hero.epa.
gov/hero/index.cfm/reference/details/
reference_id/10532909.
USEPA. 2018a. Draft Atrazine Human Health
Risk Assessment for Registration Review.
EPA–HQ–OPP–2013–0266–1256.
Washington, DC: U.S. Environmental
Protection Agency (USEPA). https://
hero.epa.gov/hero/index.cfm/reference/
details/reference_id/10533087.
USEPA. 2018b. Simazine: Human Health
Risk Assessment for Registration Review
and to Support the Registration of
Proposed Uses on Citrus Fruit (Crop
Group 10–10), Pome Fruit (Crop Group
11–10), Stone Fruit (Crop Group 12–12),
Tree Nuts (Crop Group 14–12), and
Tolerance Amendment for Almond
Hulls. Washington, DC: U.S.
Environmental Protection Agency
(USEPA), Office of Chemical Safety and
Pollution Prevention. https://hero.epa.
gov/hero/index.cfm/reference/details/
reference_id/10533123.
USEPA. 2019. Information Collection
Request Submitted to OMB for Review
and Approval; Comment Request;
Contaminant Occurrence Data in
Support of the EPA’s Fourth Six-Year
Review of National Primary Drinking
Water Regulations. 84 FR 58381. October
31, 2019.
USEPA. 2020a. Microbial Disinfection
Byproducts Rules: Public Meeting to
Inform Potential Rule Revisions. Notice.
85 FR 61680. September 30, 2020.
USEPA. 2020b. Diquat. Human Health Risk
Assessment for the Establishment Of A
VerDate Sep<11>2014
17:25 Jul 22, 2024
Jkt 262001
Tolerance Without U.S. Registration For
Residues in/on Crop Subgroup 6C Dried
Shelled Pea and Bean (Except Soybean).
EPA–HQ–OPP–2017–0291–0009.
Washington, DC: U.S. Environmental
Protection Agency (USEPA), Office of
Chemical Safety and Pollution
Prevention. https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/10533339.
USEPA. 2020c. Picloram Draft Human Health
Risk Assessment in Support of
Registration Review. Washington, DC:
U.S. Environmental Protection Agency
(USEPA), Office of Chemical Safety and
Pollution Prevention, Health Effects
Division. https://hero.epa.gov/hero/
index.cfm/reference/details/reference_
id/10533340.
USEPA. 2020d. ‘‘The Standardized
Monitoring Framework: A Quick
Reference Guide.’’ EPA 816–F–20–002.
May 2020. https://www.epa.gov/
dwreginfo/standardized-monitoringframework-quick-reference-guide.
USEPA. 2020e. Use of Total Nitrate and
Nitrite Analysis for Compliance
Determinations with the Nitrate
Maximum Contaminant Level (WSG
213). November 30, 2020. https://
www.epa.gov/sites/default/files/2021-01/
documents/wsg_213_nitrate_wsg_11-302020_signed_508-compliantfinal.pdf.
USEPA. 2020f. Clarification of Free and Total
Cyanide Analysis for Safe Drinking
Water Act (SDWA) Compliance Revision
1.0. EPA 815–B–20–004. June 2020.
USEPA. 2022a. Request for Nominations for
the Science Advisory Board
Radionuclide Cancer Risk Coefficients
Review Panel. 87 FR 15988. March 21,
2022.
USEPA. 2022b. Availability of the Draft IRIS
Toxicological Review of Hexavalent
Chromium. 87 FR 63774. October 10,
2022.
USEPA. 2023a. National Primary Drinking
Water Regulations for Lead and Copper:
Improvements (LCRI). 88 FR 84878.
December 6, 2023.
USEPA. 2023b. Availability of the Protocol
for the Nitrate and Nitrite IRIS
Assessment (Oral). 88 FR 77310.
November 9, 2023.
USEPA. 2024a. PFAS National Primary
Drinking Water Regulation. 89 FR 32532.
April 26, 2024.
USEPA. 2024b. National Primary Drinking
Water Regulations: Consumer
Confidence Report Rule Revisions. 89 FR
45980. May 24, 2024.
USEPA. 2024c. EPA Protocol for the Fourth
Review of Existing National Primary
Drinking Water Regulations. EPA 815–R–
24–018.
USEPA. 2024d. Data Management and
Quality Assurance/Quality Control
Process for the Fourth Six-Year Review
Information Collection Request Dataset.
EPA 815–R–24–017.
USEPA. 2024e. Chemical Contaminant
Summaries for the Fourth Six-Year
Review of Existing National Primary
Drinking Water Regulations. EPA 815–S–
24–002.
USEPA. 2024f. Results of the Health Effects
Assessment for the Fourth Six-Year
PO 00000
Frm 00055
Fmt 4700
Sfmt 4700
59645
Review of Existing Chemical and
Radionuclide National Primary Drinking
Water Standards. EPA 815–R–24–020.
USEPA. 2024g. Analytical Feasibility
Support Document for the Fourth SixYear Review of National Primary
Drinking Water Regulations. EPA 815–R–
24–015.
USEPA. 2024h. Analysis of Regulated
Contaminant Occurrence Data from
Public Water Systems in Support of the
Fourth Six-Year Review of National
Primary Drinking Water Regulations:
Chemical Phase and Radionuclides
Rules. EPA 815–R–24–014.
USEPA. 2024i. Review of Fluoride
Occurrence for the Fourth Six-Year
Review. EPA 815–R–24–021.
USEPA. 2024j. Occurrence Analysis for
Potential Source Waters for the Fourth
Six-Year Review of National Primary
Drinking Water Regulations. EPA 815–R–
24–019.
USEPA. 2024k. Support Document for the
Fourth Six-Year Review of Drinking
Water Regulations for Acrylamide and
Epichlorohydrin. EPA 815–R–24–023.
USEPA. 2024l. Consideration of Other
Regulatory Revisions in Support of the
Fourth Six-Year Review of the National
Primary Drinking Water Regulations:
Chemical Phase Rules and Radionuclides
Rule. EPA 815–R–24–016.
USEPA. 2024m. Six-Year Review 4 Technical
Support Document for Microbial
Contaminant Regulations. EPA 815–R–
24–022.
Wallender, E.K., E.C. Ailes, J.S. Yoder, V.A.
Roberts, and J.M. Brunkard. 2014.
Contributing factors to disease outbreaks
associated with untreated groundwater.
Ground Water. 52(6): 886–97.
World Health Organization (WHO). 2004.
Guidelines for Drinking-Water Quality,
Third Edition. Volume 1:
Recommendations. https://www.who.int/
publications/i/item/9789241547611.
WHO. 2009. Guide to hygiene and sanitation
in aviation, 3rd edition. https://www.
who.int/publications/i/item/97892415
47772.
Michael S. Regan,
Administrator.
[FR Doc. 2024–15807 Filed 7–22–24; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2023–0221; FRL–11818–01–
OCSPP]
Trichoderma Atroviride Strain AT10;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
SUMMARY:
E:\FR\FM\23JYR1.SGM
23JYR1
Agencies
[Federal Register Volume 89, Number 141 (Tuesday, July 23, 2024)]
[Rules and Regulations]
[Pages 59623-59645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15807]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 141
[EPA-HQ-OW-2023-0572; FRL 7946-01-OW]
National Primary Drinking Water Regulations; Announcement of the
Results of EPA's Fourth Review of Existing Drinking Water Standards
AGENCY: Environmental Protection Agency (EPA).
ACTION: Results of regulatory review.
-----------------------------------------------------------------------
SUMMARY: The Safe Drinking Water Act (SDWA) requires the U.S.
Environmental Protection Agency (EPA or the agency) to conduct a review
every six years of existing national primary drinking water regulations
(NPDWRs) and determine which, if any, are appropriate for revision. The
purpose of the review, called the Six-Year Review, is to evaluate
available information for regulated contaminants to determine if any
new information on health effects, treatment technologies, analytical
methods, occurrence, exposure, implementation, and/or other factors
provides a basis to support a regulatory revision that would improve or
strengthen public health protection. While EPA has recently completed
several significant revisions to existing regulations and other
regulatory revisions are currently underway, based on this periodic
review of all NPDWRs, there are no additional candidates for regulatory
revision at this time.
DATES: July 23, 2024.
ADDRESSES: EPA is not accepting public comment on the review results.
FOR FURTHER INFORMATION CONTACT: Samuel Hernandez, Environmental
Protection Agency, Office of Ground Water and Drinking Water, Standards
and Risk Management Division, (Mail Code 4607M), 1200 Pennsylvania
Avenue NW, Washington, DC 20460; telephone number: (202) 564-1735;
email address: [email protected].
SUPPLEMENTARY INFORMATION:
Abbreviations and acronyms: The following acronyms and
abbreviations are used throughout this document.
2,4-D--2,4-Dichlorophenoxyacetic acid
ADWR--Aircraft Drinking Water Rule
BAT--Best Available Technology
CFR--Code of Federal Regulations
CVOC--Carcinogenic Volatile Organic Contaminant
CWS--Community Water System
DBCP--1,2-Dibromo-3-Chloropropane
DBP--Disinfection Byproduct
DEHA--Di(2-ethylhexyl)adipate
DEHP--Di(2-ethylhexyl)phthalate
EPA--U.S. Environmental Protection Agency
EQL--Estimated Quantitation Level
FBRR--Filter Backwash Recycling Rule
GWR--Ground Water Rule
HAA5--Haloacetic Acids (five) (sum of monochloroacetic acid,
dichloroacetic acid, trichloroacetic acid, monobromoacetic acid, and
dibromoacetic acid)
ICR--Information Collection Request
IRIS--Integrated Risk Information System
LT2--Long-Term 2 Enhanced Surface Water Treatment Rule
MCLG--Maximum Contaminant Level Goal
MCL--Maximum Contaminant Level
MDBP--Microbial and Disinfection Byproduct
MDL--Method Detection Limit
MRDLG--Maximum Residual Disinfectant Level Goal
MRDL--Maximum Residual Disinfectant Level
MRL--Minimum Reporting Level
NAS--National Academy of Sciences
NCWS--Non-Community Water System
NDWAC--National Drinking Water Advisory Council
NPDWR--National Primary Drinking Water Regulations
NRC--National Research Council
NTP--National Toxicology Program
PCBs--Polychlorinated biphenyls
PCE--Tetrachloroethylene
PQL--Practical Quantitation Limit
PT--Proficiency Testing
PWS--Public Water System
RfD--Reference Dose
RSC--Relative Source Contribution
RTCR--Revised Total Coliform Rule
SDWA--Safe Drinking Water Act
SDWIS--Safe Drinking Water Information System
SWTR--Surface Water Treatment Rule
TCDD--Tetrachlorodibenzo-p-dioxin
TCE--Trichloroethylene
TCR--Total Coliform Rule
TNCWS--Transient Non-Community Water System
TTHM--Total Trihalomethanes (sum of four THMs: chloroform,
bromodichloromethane, dibromochloromethane, and bromoform)
TT--Treatment Technique
USGS--U.S. Geological Survey
Table of Contents
I. General Information
A. Does this action apply to me?
B. How can I get copies of this document and other related
information?
II. Statutory Requirements for the Six-Year Review
III. Regulations Included in the Six-Year Review 4
IV. EPA's Protocol for Reviewing the NPDWRs Included in This Action
A. What was EPA's review process?
B. How did EPA conduct the review of the NPDWRs?
1. Initial Review
2. Health Effects
[[Page 59624]]
3. Analytical Feasibility
4. Occurrence and Exposure Analysis
5. Treatment Feasibility
6. Risk-Balancing
7. Other NPDWR Revisions
V. Results of EPA's Review of NPDWRs
A. Overview of Six-Year Review 4 Results
B. Chemical Phase Rules/Radionuclides Rules
1. Key Review Outcomes
2. Summary of Review Results
3. Select NPDWRs with New Information Not Appropriate for
Revision
C. Microbial Contaminants Regulations
VI. References
I. General Information
A. Does this action apply to me?
This action itself does not impose any requirements on individual
people or entities. Instead, it notifies interested parties of EPA's
review of existing national primary drinking water regulations (NPDWRs)
and its conclusions about which of these NPDWRs may warrant regulatory
revisions at this time. The Six-Year Review is not a final regulatory
decision to revise or not revise an NPDWR, but rather a planning
process that involves more detailed analyses of factors relevant to
deciding whether a rulemaking to revise an NPDWR should be initiated.
B. How can I get copies of this document and other related information?
1. Docket. EPA has established a docket for this action under
Docket ID No. EPA-HQ-OW-2023-0572. Publicly available docket materials
are available electronically on www.regulations.gov or in hard copy at
the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution
Ave. NW, Washington, DC. 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.
2. Electronic Access. You may access this Federal Register document
electronically from https://www.federalregister.gov.
II. Statutory Requirements for the Six-Year Review
Under the Safe Drinking Water Act (SDWA), as amended in 1996, EPA
must periodically review existing NPDWRs and, if appropriate, revise
them. Section 1412(b)(9) of the SDWA states: ``The Administrator shall,
not less often than every six years, review and revise, as appropriate,
each national primary drinking water regulation promulgated under this
title. Any revision of a national primary drinking water regulation
shall be promulgated in accordance with this section, except that each
revision shall maintain, or provide for greater, protection of the
health of persons.''
Pursuant to the 1996 SDWA Amendments, EPA completed and published
the results of its first Six-Year Review (Six-Year Review 1) on July
18, 2003 (68 FR 42908, USEPA, 2003), the second Six-Year Review (Six-
Year Review 2) on March 29, 2010 (75 FR 15500, USEPA, 2010a) and the
third Six-Year Review (Six-Year Review 3) on January 11, 2017 (82 FR
3518, USEPA, 2017a).
During the Six-Year Review 1, EPA identified the Total Coliform
Rule (TCR) as a candidate for revision.\1\ In Six-Year Review 2, EPA
identified four NPDWRs corresponding to acrylamide, epichlorohydrin,
tetrachloroethylene (PCE), and trichloroethylene (TCE) as candidates
for revision. In Six-Year Review 3, eight NPDWRs were listed as
candidates for revision, including: chlorite, Cryptosporidium (under
SWTRs), Giardia lamblia, haloacetic acids (HAA5), heterotrophic
bacteria, Legionella, total trihalomethanes (TTHM), and viruses (under
SWTRs). EPA also announced that the NPDWRs for acrylamide and
epichlorohydrin were no longer candidates for revision due to low
opportunity for further reduction of public health risk through
regulatory revision (82 FR 3525, USEPA, 2017a).
---------------------------------------------------------------------------
\1\ The NPDWRs apply to specific contaminants/parameters or
groups of contaminants. Historically, when issuing new or revised
standards for these contaminants/parameters, EPA has often grouped
the standards together in more general regulations, such as the
Total Coliform Rule, the Surface Water Treatment Rule or the Phase V
rules. In this action, however, for clarity, EPA discusses the
drinking water standards as they apply to each specific regulated
contaminant/parameter (or group of contaminants), not the more
general regulation in which the contaminant/parameter was regulated.
---------------------------------------------------------------------------
In this document, EPA is announcing the results of the fourth Six-
Year Review (Six-Year Review 4). EPA's announcement of whether to
identify an NPDWR as a candidate for revision (pursuant to SDWA section
1412(b)(9)) is not a regulatory decision. Instead, announcing that an
NPDWR is a candidate for revision formally initiates a regulatory
process that involves more detailed analyses of health effects,
analytical constraints, treatment feasibility, occurrence, benefits,
costs, and other policy considerations relevant to informing an NPDWR
revision effort. The Six-Year Review results do not obligate the agency
to revise an NPDWR if EPA determines during the regulatory process that
revisions are no longer appropriate and discontinues further efforts to
revise the NPDWR. Similarly, when EPA announces that a particular NPDWR
has not been identified as a candidate for revision it means that the
agency has concluded that it is not appropriate for revision at this
time based on available information.
The criteria that EPA has applied to help identify when an NPDWR
might be considered as a ``candidate for revision'' are, at a minimum,
that the regulatory revision presents a meaningful opportunity to
improve the level of public health protection, and/or achieve cost
savings while maintaining or improving the level of public health
protection.
III. Regulations Included in the Six-Year Review 4
Table 1 of this document lists all 94 NPDWRs established to date.
The table also reports the maximum contaminant level goal (MCLG) and,
where applicable, the maximum contaminant level (MCL). The MCLG is
``set at the level at which no known or anticipated adverse effects on
the health of persons occur and which allows an adequate margin of
safety'' (SDWA section 1412(b)(4)). The MCL for each applicable NPDWR,
is the maximum permissible level of a contaminant in water delivered to
any user of a public water system (PWS) and generally ``is as close to
the maximum contaminant level goal as is feasible'' (SDWA section
1412(b)(4)(B)). If it is not ``economically or technically feasible to
ascertain the level of the contaminant,'' EPA can require the use of a
treatment technique (TT) in lieu of establishing an MCL. The treatment
technique(s) must prevent known or anticipated adverse health effects
``to the extent feasible'' (SDWA section 1412(b)(7)(A)).\2\ In the case
of disinfectants (e.g., chlorine, chloramines, chlorine dioxide), the
values reported in the table are not MCLGs and MCLs, but maximum
residual disinfectant level goals (MRDLGs) and maximum residual
disinfectant levels (MRDLs).
---------------------------------------------------------------------------
\2\ Under limited circumstances, SDWA section 1412(b)(6)(A)
gives the Administrator the discretion to promulgate an MCL or TT
that is less stringent than the most protective feasible standard
that ``maximizes health risk reduction benefits at a cost that is
justified by the benefits.'' Similarly, SDWA section 1412(b)(5)
authorizes the Administrator to promulgate an MCL or TT that is less
stringent than the most protective feasible standard if the more
protective standard would increase the level of other contaminants
in drinking water or interfere with the efficacy of treatment
techniques or process used for compliance with other NPDWRs. Under
those circumstances, EPA is to promulgate feasible a MCL or TT rule
to ``minimize the oversall risk of adverse health effects'' while
avoiding an increase in health risks from other contaminants.
---------------------------------------------------------------------------
[[Page 59625]]
As part of the fourth Six-Year Review, EPA did not consider
information after December 2021, unless otherwise noted. EPA identified
15 NPDWRs for which there has either been a recently completed, an
ongoing, or a pending regulatory action. EPA did not conduct a detailed
review of these 15 NPDWRs for the Six-Year Review 4. These include the
ongoing Lead & Copper rulemaking activities and the potential revisions
\3\ of the Microbial and Disinfection Byproduct Rules (MDBP). The MDBP
effort contemplates potential regulatory revisions for the NPDWRs
covering the following contaminants: (Bromate, Chloramines, Chlorine
Dioxide, Chlorine, Chlorite, Cryptosporidium, Giardia lamblia,
Haloacetic acids, Heterotrophic bacteria, Legionella, Total
Trihalomethanes, Turbidity, & Viruses).
---------------------------------------------------------------------------
\3\ Additional information can be found at https://www.epa.gov/system/files/documents/2022-04/mdbp-rule-revisions-charge-to-the-ndwac.pdf.
---------------------------------------------------------------------------
The EPA did not include in this Six-Year Review cycle the recently
promulgated per-and polyfluoroalkyl substances (PFAS) regulations.\4\
The PFAS regulations, promulgated in April 2024, established 6 new
NPDWRs. The EPA anticipates that once the PFAS regulations go into
effect and sufficient information regarding compliance monitoring
becomes available, those NPDWRs will be subject to a more detailed
regulatory review under a future Six-Year Review cycle. This document
describes the detailed review of the remaining 73 NPDWRs. section IV of
this document describes the Six-Year Review 4 protocol, and section V
of this document describes the review results. Please see USEPA (2024a)
for more details.
---------------------------------------------------------------------------
\4\ On April 26, 2024, the EPA promulgated legally enforceable
drinking water standards to address PFAS known to occur individually
and as mixtures in drinking water (89 FR 32532). The NPDWRs sets
limits for five individual PFAS: (perfluorooctanoic acid (PFOA),
perfluorooctane sulfonic acid (PFOS), perfluorohexane sulfonic acid
(PFHxS), perfluorononanoic acid (PFNA), hexafluoropropylene oxide
dimer acid (HFPO-DA, commonly known as GenX Chemicals)); and also
established a limit for mixtures of any two or more of the following
four PFAS: (PFNA, PFHxS, perfluorobutane sulfonic acid (PFBS), and
HFPO-DA).
Table 1--List of NPDWRs
--------------------------------------------------------------------------------------------------------------------------------------------------------
MCL or TT (mg/L) 2 3 Contaminants/ MCL or TT (mg/L) 2 3
Contaminants/parameters MCLG (mg/L) 1 3 parameters MCLG (mg/L) 1 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acrylamide...................... 0...................... TT..................... Giardia lamblia 0...................... TT.
\4\.
Alachlor........................ 0...................... 0.002.................. Glyphosate........ 0.7.................... 0.7.
Alpha/photon emitters........... 0 (pCi/L).............. 15 (pCi/L)............. Haloacetic acids n/a \5\................ 0.060.
(HAA5).
Antimony........................ 0.006.................. 0.006.................. Heptachlor........ 0...................... 0.0004.
Arsenic......................... 0...................... 0.010.................. Heptachlor epoxide 0...................... 0.0002.
Asbestos........................ 7 (million fibers/L)... 7 (million fibers/L)... Heterotrophic n/a.................... TT.
bacteria \6\.
Atrazine........................ 0.003.................. 0.003.................. Hexachlorobenzene. 0...................... 0.001.
Barium.......................... 2...................... 2...................... Hexachlorocyclopen 0.05................... 0.05.
tadiene.
Benzene......................... 0...................... 0.005.................. Hexafluoropropylen 10 (ppt)............... 10 (ppt).
e oxide dimer
acid (HFPO-DA).
Benzo[a]pyrene.................. 0...................... 0.0002................. Lead.............. 0...................... TT.
Beryllium....................... 0.004.................. 0.004.................. Legionella........ 0...................... TT.
Beta/photon emitters............ 0 (millirems/yr)....... 4 (millirems/yr)....... Lindane........... 0.0002................. 0.0002.
Bromate......................... 0...................... 0.010.................. Mercury 0.002.................. 0.002.
(inorganic).
Cadmium......................... 0.005.................. 0.005.................. Methoxychlor...... 0.04................... 0.04.
Carbofuran...................... 0.04................... 0.04................... Monochlorobenzene 0.1.................... 0.1.
(Chlorobenzene).
Carbon tetrachloride............ 0...................... 0.005.................. Nitrate (as N).... 10..................... 10.
Chloramines (as Cl2)............ 4...................... 4.0.................... Nitrite (as N).... 1...................... 1.
Chlordane....................... 0...................... 0.002.................. Oxamyl (Vydate)... 0.2.................... 0.2.
Chlorine (as Cl2)............... 4...................... 4.0.................... Pentachlorophenol. 0...................... 0.001.
Chlorine dioxide (as ClO2)...... 0.8.................... 0.8.................... Perfluorohexane 10 (ppt)............... 10 (ppt).
sulfonic acid
(PFHxS).
Chlorite........................ 0.8.................... 1.0.................... Perfluorononanoic 10 (ppt)............... 10 (ppt).
acid (PFNA).
Chromium (total)................ 0.1.................... 0.1.................... Perfluorooctane 0 (ppt)................ 4.0 (ppt).
sulfonic acid
(PFOS).
Copper.......................... 1.3.................... TT..................... Perfluorooctanoic 0 (ppt)................ 4.0 (ppt).
acid (PFOA).
Cryptosporidium................. 0...................... TT..................... PFAS Mixture (HFPO- Hazard Index \12\ of 1. Hazard Index of 1.
DA, PFBS, PFHxS,
& PFNA).
Cyanide (as free cyanide)....... 0.2.................... 0.2.................... Picloram.......... 0.5.................... 0.5.
2,4-Dichlorophenoxyacetic acid 0.07................... 0.07................... Polychlorinated 0...................... 0.0005.
(2,4-D). biphenyls (PCBs).
Dalapon......................... 0.2.................... 0.2.................... Radium 226/228 0 (pCi/L).............. 5 (pCi/L).
(combined).
Di(2-ethylhexyl)adipate (DEHA).. 0.4.................... 0.4.................... Selenium.......... 0.05................... 0.05.
Di(2-ethylhexyl)phthalate (DEHP) 0...................... 0.006.................. Simazine.......... 0.004.................. 0.004.
1,2-Dibromo-3- chloropropane 0...................... 0.0002................. Styrene........... 0.1.................... 0.1.
(DBCP).
1,2-Dichlorobenzene (o- 0.6.................... 0.6.................... 2,3,7,8-TCDD 0...................... 3 x10 -8.
Dichlorobenzene). (Dioxin).
1,4-Dichlorobenzene (p- 0.075.................. 0.075.................. Tetrachloroethylen 0...................... 0.005.
Dichlorobenzene). e.
1,2-Dichloroethane (ethylene 0...................... 0.005.................. Thallium.......... 0.0005................. 0.002.
dichloride).
1,1-Dichloroethylene............ 0.007.................. 0.007.................. Toluene........... 1...................... 1.
cis-1,2-Dichloroethylene........ 0.07................... 0.07................... Total coliforms 7 n/a.................... TT.
8.
trans-1,2-Dichloroethylene...... 0.1.................... 0.1.................... Total n/a \9\................ 0.080.
Trihalomethanes
(TTHM).
Dichloromethane (methylene 0...................... 0.005.................. Toxaphene......... 0...................... 0.003.
chloride).
1,2-Dichloropropane............. 0...................... 0.005.................. 2,4,5-TP (Silvex). 0.05................... 0.05.
Dinoseb......................... 0.007.................. 0.007.................. 1,2,4- 0.07................... 0.07.
Trichlorobenzene.
Diquat.......................... 0.02................... 0.02................... 1,1,1- 0.2.................... 0.2.
Trichloroethane.
E. coli......................... 0...................... MCL,\10\ TT 8 11....... 1,1,2- 0.003.................. 0.005.
Trichloroethane.
Endothall....................... 0.1.................... 0.1.................... Trichloroethylene. 0...................... 0.005.
Endrin.......................... 0.002.................. 0.002.................. Turbidity \6\..... n/a.................... TT.
Epichlorohydrin................. 0...................... TT..................... Uranium........... 0...................... 0.030.
Ethylbenzene.................... 0.7.................... 0.7.................... Vinyl Chloride.... 0...................... 0.002.
Ethylene dibromide (EDB)........ 0...................... 0.00005................ Viruses........... 0...................... TT.
Fluoride........................ 4.0.................... 4.0.................... Xylenes (total)... 10..................... 10.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ MCLG: the maximum level of a contaminant in drinking water at which no known or anticipated adverse effect on the health of persons would occur,
allowing an adequate margin of safety. Maximum contaminant level goals are nonenforceable health goals.
[[Page 59626]]
\2\ MCL: the maximum level allowed of a contaminant in water which is delivered to any user of a public water system. TT: any action, process, or
procedure required of the water system that leads to the reduction of the level of a contaminant in tap water that reaches the consumer.
\3\ Units are in milligrams per liter (mg/L) unless otherwise noted. Milligrams per liter are equivalent to parts per million. For chlorine,
chloramines, and chlorine dioxide, values presented are MRDLG and MRDL.
\4\ The current preferred taxonomic name is Giardia duodenalis, with Giardia lamblia and Giardia intestinalis as synonymous names. However, Giardia
lamblia was the name used to establish the MCLG in 1989. Elsewhere in this document, this pathogen will be referred to as Giardia spp. or simply
Giardia unless discussing information on an individual species.
\5\ There is no MCLG for all five haloacetic acids. MCLGs for some of the individual contaminants are: dichloroacetic acid (zero), trichloroacetic acid
(0.02 mg/L), and monochloroacetic acid (0.07 mg/L). Bromoacetic acid and dibromoacetic acid are regulated with this group but have no MCLGs.
\6\ Includes indicators that are used in lieu of direct measurements (e.g., of heterotrophic bacteria, turbidity).
\7\ The Aircraft Drinking Water Rule (ADWR) 40 CFR part 141 subpart X, promulgated October 19, 2009, covers total coliforms and E. coli.
\8\ Under the RTCR, a PWS is required to conduct an assessment if it exceeded any of the TT triggers identified in 40 CFR 141.859(a). It is also
required to correct any sanitary defects found through the assessment. 40 CFR 141.859(c).
\9\ There is no MCLG for total trihalomethanes (TTHM). MCLGs for some of the individual contaminants are: bromodichloromethane (zero), bromoform (zero),
dibromochloromethane (0.06 mg/L), and chloroform (0.07 mg/L).
\10\ A PWS is in compliance with the E. coli MCL unless any of the conditions identified under 40 CFR 141.63(c) occur.
\11\ Under the GWR in 40 CFR 141.402, a ground water system that does not provide at least 4-log treatment of viruses and has a distribution system RTCR
sample that tests positive for total coliform is required to conduct triggered source water monitoring to evaluate whether the total coliform presence
in the distribution system is due to fecal contamination in the ground water source. The system must monitor for one of three State-specified fecal
indicators (i.e., E. coli, coliphage, or enterococci).
\12\ The Hazard Index is an approach that EPA uses to determine the health concerns associated with mixtures of certain PFAS in finished drinking water.
The Hazard Index is made up of a sum of fractions. Each fraction compares the level of each PFAS measured in the water to the associated health-based
water concentration.
IV. EPA's Protocol for Reviewing the NPDWRs Included in This Action
A. What was EPA's review process?
This section provides an overview of the process EPA used to review
the NPDWRs discussed in this document. The protocol document, ``EPA
Protocol for the Fourth Review of Existing National Primary Drinking
Water Regulations,'' contains a detailed description of the process the
agency used to review the NPDWRs (USEPA, 2024c). The foundation of this
protocol was developed for the Six-Year Review 1 based on the
recommendations of the National Drinking Water Advisory Council (NDWAC,
2000) and has undergone minor clarifications during each Six-Year
Review cycle (USEPA, 2024c). Figure 1 presents an overview of the Six-
Year Review protocol and the possible review outcomes.
The objective of the Six-Year Review process is to identify and
prioritize NPDWRs for possible regulatory revision. The two major
outcomes of the detailed review are either (1) the NPDWR is not
appropriate for revision and no action is necessary at this time or (2)
the NPDWR is a candidate for revision.
The reasons why EPA might list an NPDWR as ``not appropriate for
revision at this time'' could include:
Recently completed, ongoing, or pending regulatory action:
The NPDWR was recently completed, is being reviewed under an ongoing
action, or is subject to a pending action.
Ongoing or planned health effects assessment: The
contaminant or contaminants regulated by the NPDWR has an ongoing or
planned health effects assessment.
No new information: EPA did not identify any new relevant
information for the contaminant since the last Six-Year Review that
indicates changes to the NPDWR may be appropriate.
Data gaps/emerging information: New information indicates
a possible change to the MCLG and/or MCL but changes to the NPDWR are
not appropriate due to data gaps and emerging information that needs to
be evaluated.
Low priority and/or no meaningful opportunity: New
information indicates a possible change to the MCLG and/or MCL but
changes to the NPDWR are not appropriate at this time due to one or
more of the following reasons: (1) possible changes present negligible
gains in public health protection; (2) possible changes present limited
opportunity for cost savings while maintaining the same or greater
level of health protection; and/or (3) possible changes are a low
priority because of competing workload priorities, limited return on
the administrative costs associated with rulemaking, and the burden on
states and the regulated community associated with implementing any
regulatory change that would result.
Alternatively, the reasons why an NPDWR could be listed as a
candidate for revision are that the regulatory revision presents a
meaningful opportunity to improve the level of public health
protection, and/or achieve cost savings while maintaining or improving
the level of public health protection.
Individual regulatory provisions that are evaluated as part of the
Six-Year Review process include: MCLG, MCL, MRDLG, MRDL, TT, best
available technology (BAT), and other requirements, such as monitoring
requirements.
For example, the microbial regulations include TT requirements
because no reliable, affordable, and technically feasible method is
available to measure the microbial contaminants covered by those
regulations. These TT requirements rely on the use of indicators that
can be measured in drinking water, such as detection of total coliforms
as an indicator of a potential pathway for pathogenic contamination in
the distribution system. As part of the Six-Year Review 4, EPA
evaluated new information related to the use of those indicators to
determine if a meaningful opportunity to improve the level of public
health protection exists. Results of EPA's review of the microbial
regulations are presented in section V of this document.
Basic Principles
EPA applied several basic principles to the Six-Year Review
process:
The agency sought to avoid redundant review efforts.
Because EPA has reviewed information for certain NPDWRs as part of
recently completed, ongoing, or pending regulatory actions, these
NPDWRs were not subject to detailed review under the Six-Year Review
process.
The agency does not believe it is appropriate to consider
revisions to NPDWRs for contaminants with an ongoing or planned health
effect assessment where the MCL is set equal to the MCLG or that were
set at the level at which health risk reduction benefits were maximized
at a cost justified by the benefits in accordance with SDWA section
1412(b)(6)(A)). This principle stems from the fact that any new health
effects assessment may affect the MCL via a change in the MCLG or the
assessment of the benefits associated with the MCL. EPA notes that
these NPDWRs are not appropriate for revision and no action is
necessary if the health effects assessment would not be completed
during the review cycle.
In evaluating the potential for new information to affect
NPDWRs, EPA assumed no change to existing policies and procedures for
developing NPDWRs. For example, in determining whether new information
affected the feasibility of analytical methods for a contaminant, the
agency assumed no
[[Page 59627]]
change to current policies and procedures for calculating practical
quantitation limits.
EPA may consider whether there is new public health risk
information to justify accelerating review and potential revision of a
particular NPDWR before the next review cycle.
Procedures
EPA also applied the following procedures in the review process:
EPA considered new information from health effects
assessments that were completed by the information cutoff date.
Assessments completed after this cutoff date will be reviewed by EPA
during the next review cycle.
During the review, EPA identified areas where relevant
information, which is needed to determine whether a revision to an
NPDWR may be appropriate, was either: inadequate, unavailable (i.e.,
data gaps), or emerging. To the extent EPA is able to fill data gaps or
fully evaluate the emerging information, the agency will consider the
information as part of the next review cycle.
Finally, EPA assured that the scientific analyses
supporting the review were consistent with the agency's peer review
policy (USEPA, 2015a).
[GRAPHIC] [TIFF OMITTED] TR23JY24.000
B. How did EPA conduct the review of the NPDWRs?
The protocol for the Six-Year Review 4 is organized as a series of
questions to inform an assessment as to the appropriateness of revising
an NPDWR. These questions are logically ordered into a decision tree.
This section provides an overview of each of the review elements that
EPA considered for each NPDWR during the Six-Year Review 4, including
the following: initial review, health effects, analytical feasibility,
occurrence and exposure, treatment feasibility, risk balancing, and
other NPDWR revisions. The final review combines the findings from all
these review elements to recommend whether an NPDWR is a candidate for
revision. Further information about the review elements is described in
the protocol document (USEPA, 2024c). The results of the Six-Year
Review are presented in section V of this document.
1. Initial Review
EPA's initial review of all the contaminants included in the Six-
Year Review 4 involved a simple identification of the NPDWRs that have
either been recently completed or are being reviewed in an ongoing or
pending action since the publication of Six-Year Review 3. In addition,
the initial review also identified contaminants with ongoing health
effects assessments that have an MCL equal to the MCLG. Excluding such
contaminants from a more detailed review in the Six-Year Review 4
prevents duplicative agency efforts.
2. Health Effects
The principal objectives of the health effects review are to
identify: (1) contaminants for which a new health effects assessment
indicates that a change in the MCLG might be appropriate (e.g., because
of a change in cancer classification or a change in reference dose
(RfD)), and (2) contaminants for which new health effects information
indicates a need to initiate a new health effects assessment.
To meet the first objective, EPA reviewed the results of health
effects assessments completed since promulgation of each NPDWR. To meet
the second objective, the agency conducted a systematic literature
search, to capture more recently published peer-reviewed studies on
relevant health effects via the oral route
[[Page 59628]]
of exposure for the general population as well as sensitive
subpopulations including children. The results of the literature search
were used to survey the health effects literature that has become
available since the previous review cycle, identify any emerging issues
for a contaminant, and identify data gaps to inform future health
assessment nominations.
3. Analytical Feasibility
When establishing an NPDWR, EPA identifies a practical quantitation
limit (PQL), which is the lowest achievable level of analytical
quantitation during routine laboratory operating conditions within
specified limits of precision and accuracy (50 FR 46880, USEPA, 1985).
EPA has a separate process in place to approve new analytical methods
for drinking water contaminants; therefore, review and approval of
potential new methods is outside the scope of the Six-Year Review
protocol. EPA recognizes, however, that the approval and adoption in
recent years of new and/or improved analytical methods may enable
laboratories to quantify contaminants at lower levels than was possible
when NPDWRs were originally promulgated. This ability of laboratories
to measure a contaminant at lower levels could affect its PQL, the
value at which an MCL is set when it is limited by analytical
feasibility. Therefore, the Six-Year Review process includes an
examination of whether there have been changes in analytical
feasibility that could possibly change the PQL for the subset of the
NPDWRs that reach this stage of the review.
To determine if changes in analytical feasibility could possibly
support changes to PQLs, EPA relied primarily on two approaches to
develop estimated quantitation levels (EQLs), which are based on either
(1) minimum reporting levels (MRLs) obtained as part of the Six-Year
Review 4 Information Collection Request (ICR), or (2) method detection
limits (MDLs) from EPA-approved laboratory protocols.
An MRL is the lowest level or contaminant concentration that a
laboratory can reliably achieve within specified limits of precision
and accuracy under routine laboratory operating conditions using a
given method. The MRL values provide direct evidence from actual
monitoring results about whether quantitation below the PQL using
current analytical methods is feasible. An MDL is a measure of
analytical sensitivity, representing the minimum reported concentration
that can be distinguished from blank results with 99 percent
confidence. MDLs have been used in the past to derive PQLs for
regulated contaminants.
EPA used the EQL as a threshold for occurrence analysis to help the
agency assess for a meaningful opportunity to improve public health
protection. It should be noted, however, that the use of an EQL does
not necessarily indicate the agency's intention to promulgate a revised
MCL based on the new PQL. Any change in the PQL for a contaminant could
be part of future rulemaking efforts if EPA decides to initiate a
regulatory revision for the contaminant.
4. Occurrence and Exposure Analysis
EPA conducted the occurrence and exposure analysis in conjunction
with other review elements to determine if an NPDWR revision would
provide a meaningful opportunity to improve public health by:
estimating the extent of contaminant occurrence, i.e., the
number of PWSs in which contaminants occur at levels of interest
(health-effects-based thresholds or analytical method limits), and;
evaluating the number of people potentially exposed to
contaminants at these levels.
To evaluate national contaminant occurrence under the Six-Year
Review 4, EPA reviewed data from the Six-Year Review 4 ICR database
(SYR 4 ICR database) and other relevant sources. EPA collected SDWA
compliance monitoring data and treatment technique information through
use of an ICR (84 FR 58381, USEPA, 2019). EPA requested that states, as
well as Tribes and territories with primacy voluntarily submit their
compliance monitoring data and treatment technique information for
regulated contaminants in PWSs. Specifically, EPA requested the
submission of compliance monitoring data, treatment technique
information, and related details collected between January 2012 and
December 2019 for regulated contaminants and related parameters (e.g.,
water quality indicators). Forty-six states plus 13 other jurisdictions
(Washington, DC, territories, and Tribes) provided data. The assembled
data constitute the largest, most comprehensive set of drinking water
compliance monitoring data and treatment technique information ever
compiled and analyzed by EPA to inform decision making, containing
almost 71 million analytical records from approximately 140,000 PWSs,
serving approximately 301 million people nationally. Through extensive
data management efforts, quality assurance evaluations, and
communications with state data management staff, EPA established the
SYR 4 ICR dataset (USEPA, 2019). The number of states and PWSs
represented in the dataset varies across contaminants because of
variability in state data submissions and contaminant monitoring
schedules. EPA considers that these data are of sufficient quality to
inform an understanding of the national occurrence of regulated
contaminants and related parameters. Details of the data management and
data quality assurance evaluations are available in the supporting
document (USEPA, 2024d). The resulting database is available online on
the Six-Year Review website at https://www.epa.gov/dwsixyearreview.
5. Treatment Feasibility
An NPDWR either identifies an MCL or establishes enforceable TT
requirements. When promulgating an MCL or enforceable treatment
technique requirements, to determine feasibility, EPA identifies the
best technology, treatment techniques, and other means which EPA finds,
after examination for efficacy under field conditions and not solely
under laboratory conditions, are available (taking cost into
consideration). When promulgating an MCL, EPA also lists the
technology, treatment techniques, or other means which are feasible for
purposes of meeting the MCL. EPA reviews treatment feasibility to
ascertain if available technologies meet BAT criteria for a
hypothetical more stringent MCL, or if new information demonstrates an
opportunity to improve public health protection through revision of an
NPDWR TT requirement.
To be a BAT, the treatment technology must meet several criteria
such as having demonstrated consistent removal of the target
contaminant under field conditions. Although treatment feasibility and
analytical feasibility are considered together in evaluating the
technical feasibility requirement for an MCL, historically, treatment
feasibility has not been a limiting factor for MCLs. The result of this
review element is a determination of whether treatment feasibility
would pose a limitation to revising an MCL or provide an opportunity to
revise the NPDWR TT requirement.
6. Risk-Balancing
EPA reviews the risk-balancing analysis underlying some NPDWRs to
examine how a potential regulatory revision would address tradeoffs in
risks associated with different contaminants. Under this review, EPA
considers whether a change to an MCL and/or TT
[[Page 59629]]
will increase the public health risk posed by one or more contaminants,
and, if so, the agency considers revisions that will balance overall
risks. This review element is relevant only to the NPDWRs included in
the microbial and disinfection byproduct (MDBP) rules, which were
promulgated to address the need for risk-balancing between microbial
and disinfection byproduct (DBP) requirements, and among differing
types of DBPs. NPDWRs for microbials and disinfectants and DBPs were
not reviewed during Six-Year Review 4 due to ongoing regulatory action
initiated by Six-Year Review 3.
7. Other NPDWR Revisions
In addition to possible revisions to MCLGs, MCLs, and TTs, EPA
evaluated whether other revisions are needed to other regulatory
provisions in NPDWRs, such as monitoring and system reporting
requirements. EPA focused this review element on issues that were not
already being addressed through alternative mechanisms, such as a
recently completed, ongoing, or pending regulatory action. EPA also
reviewed implementation-related NPDWR concerns that were ``ready'' for
rulemaking--that is, the problem to be resolved had been clearly
identified, along with specific options to address the problem that
could be shown to either clearly improve the level of public health
protection or represent a meaningful opportunity for achieving cost
savings while maintaining the same level of public health protection.
The result of this review element is a determination regarding whether
EPA should consider revisions to the monitoring and/or reporting
requirements of an NPDWR.
V. Results of EPA's Review of NPDWRs
A. Overview of Six-Year Review 4 Results
Table 2 of this document, lists the results of EPA's review of the
88 NPDWRs assessed during Six-Year Review 4, along with the principal
rationale for the review outcomes. Table 2 includes the 15 NPDWRs that
have ongoing or pending regulatory actions.
Table 2--Summary of Six-Year Review 4 Results
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Outcome Regulated contaminants
----------------------------------------------------------------------------------------------------------------
Not Appropriate for Revision at Recently completed, ongoing or pending Bromate........... Haloacetic acids
this Time. regulatory action. Chloramines (as (HAA5).
Cl2). Heterotrophic
Chlorine Dioxide bacteria.
(as ClO2). Lead.
Chlorine (as Cl2). Legionella.
Chlorite.......... Total
Copper............ Trihalomethanes
Cryptosporidium (TTHM).
(IE, LT1) \1\. Turbidity.
Giardia lamblia... Viruses (SWTR, IE,
LT1).\1\
----------------------------------------------------------------------------------------------------------------
Not Appropriate for Revision at Health effects assessment in process Alpha/photon Mercury
this Time. or contaminant nominated for health emitters. (inorganic).
assessment. Arsenic........... Polychlorinated
Beta/photon biphenyls (PCBs).
emitters. Radium 226/228
Chromium (total).. (combined).
Ethylbenzene...... Uranium.
-------------------------------------------------------------------------------
No new information, NPDWR remains Asbestos.......... trans-1,2-
appropriate after review. Benzo(a)pyrene.... Dichloroethylene.
Chlorobenzene..... Dinoseb.
Dalapon........... E. coli.
Di(2- Endrin.
ethylhexyl)adipat Ethylene
e (DEHA). dibromide.
Di(2- 2,4,5-TP (Silvex).
ethylhexyl)phthal
ate (DEHP).
1,2-Dibromo-3-
chloropropane
(DBCP).
-------------------------------------------------------------------------------
New information, Low priority and/ Acrylamide........ Heptachlor.
but no revision or no meaningful Alachlor.......... Heptachlor
recommended opportunity. Antimony.......... Epoxide.
because . . . Atrazine.......... Hexachlorobenzene.
Barium............ Hexachlorocyclopen
Benzene........... tadiene.
Lindane.
Methoxychlor.
Beryllium......... Oxamyl (Vydate).
Cadmium........... Pentachlorophenol.
Carbofuran........ Picloram.
Carbon Selenium.
Tetrachloride. Simazine.
Chlordane......... Styrene.
Cryptosporidium Tetrachloroethylen
(LT2) \1\. e (PCE).
1,2- Thallium.
Dichlorobenzene. 1,2,4-
1,4- Trichlorobenzene.
Dichlorobenzene. 1,1,1-
1,2-Dichloroethane Trichloroethane.
1,1- 1,1,2-
Dichloroethylene. Trichloroethane.
cis-1,2- Toluene.
Dichloroethylene.
Dichloromethane...
2,4- Total Coliform.
Dichlorophenoxyac Toxaphene.
etic acid (2,4-D). Trichloroethylene
1,2-Dichoropropane (TCE).
Dioxin (2,3,7,8- Vinyl Chloride.
TCDD). Xylenes.
Diquat............
Endothall.........
Epichlorohydrin...
Glyphosate........
-----------------------------------------------------------
Emerging Cyanide (as free Nitrate.
information and/ cyanide). Nitrite.
or data gaps. Fluoride..........
----------------------------------------------------------------------------------------------------------------
Candidate for Revision.......... New information.
None.
----------------------------------------------------------------------------------------------------------------
\1\ Regulation abbreviations: Aircraft Drinking Water Rule (ADWR), Ground Water Rule (GWR), Revised Total
Coliform Rule (RTCR), Surface Water Treatment Rule (SWTR), Interim Enhanced Surface Water Treatment Rule (IE),
Long Term 1 Enhanced Surface Water Treatment Rule (LT1), and Long Term 2 Enhanced Surface Water Treatment Rule
(LT2).
[[Page 59630]]
EPA has identified no appropriate candidates for revision at this
time.
EPA's Office of Ground Water and Drinking Water is currently
engaged in several ongoing and potential regulatory actions, in
addition to being involved in the efforts to successfully implement
recently promulgated rules including:
Developing a proposal to revise the Microbial and
Disinfection By-Product Rules, including eight NPDWRs listed as
candidates for revision in Six-Year Review 3 (85 FR 61680, USEPA,
2020a).
On December 6, 2023, EPA published the proposed rule
``National Primary Drinking Water for Lead and Copper: Improvements''
(88 FR 84878, USEPA, 2023a).
In January 2024, EPA announced its commitment to
promulgate a National Primary Drinking Water Regulation for Perchlorate
by May 2027.\5\
---------------------------------------------------------------------------
\5\ Additional information can be found at https://www.epa.gov/sdwa/perchlorate-drinking-water.
---------------------------------------------------------------------------
On April 26, 2024, EPA published the PFAS final rule
``PFAS National Primary Drinking Water Regulation'' (89 FR 32532,
USEPA, 2024a).
On May 24, 2024, EPA published the final rule ``National
Primary Drinking Water Regulations: Consumer Confidence Reports'' (89
FR 45980, USEPA, 2024b).
Therefore, when evaluating the review results described in sections
V.B and V.C of this document, EPA also considered competing workloads
and potential diversion of resources from these other planned, ongoing,
and pending higher priority efforts within the drinking water office.
B. Chemical Phase Rules/Radionuclides Rules
The NPDWRs for chemical contaminants, collectively called the Phase
Rules, were promulgated between 1987 and 1992, following the 1986 SDWA
amendments. In December 2000, EPA promulgated final radionuclide
regulations, which had been issued as interim rules in July 1976.
1. Key Review Outcomes
EPA has decided that it is not appropriate at this time to revise
any of the NPDWRs covered under the Phase or Radionuclides Rules (Table
2 of this document). These NPDWRs were determined not to be candidates
for revision for one or more of the following reasons:
ongoing/pending regulatory action warrants waiting for
further review;
no new information was identified to suggest possible
changes in MCLG/MCL;
new information did not present a meaningful opportunity
for health risk reduction or cost savings while maintaining/improving
public health protection;
emerging information and/or data gaps create substantial
uncertainty.
In addition, EPA is announcing that the NPDWRs for
trichloroethylene (TCE) and tetrachloroethylene (PCE) are no longer
candidates for revision at this time. In March 2010, as an outcome of
the second cycle of Six-Year Review, EPA listed the TCE and PCE NPDWRs
as candidates for revision (75 FR 15500, USEPA, 2010a). TCE and PCE
were not reviewed under Six-Year Review 3 because regulatory revisions
were being considered as part of plans to address regulated and
unregulated Carcinogenic Volatile Organic Contaminants (cVOCs) in a
group rule (75 FR 3525, January 21, 2010; 82 FR 3531, USEPA, 2017a).
However, after evaluating currently available information for both of
these chemicals, the EPA concludes that these NPDWRS are not
appropriate for revision at this time because minimal reductions in
health risks would be associated with any revisions to these
regulations. Given resource limitations, competing workload priorities,
and administrative costs and burden to states to adopt any regulatory
changes associated with rulemakings, as well as limited potential
health benefits, these NPDWRs are considered a low priority and are no
longer candidates for revision at this time.
Section V.B.2 of this document describes the results of the review
organized by each review element. Section V.B.3 of this document
includes a description of the new information gathered by EPA for
select contaminants that EPA determined are not candidates for revision
at this time due to emerging information or data gaps or no meaningful
opportunity for health risk reduction. The contaminants discussed in
detail in section V.B.3 of this document are cyanide, fluoride,
nitrate, nitrite, TCE, and PCE.
Review results organized by contaminant for the Chemical Phase and
Radionuclides Rules can be found in the ``Chemical Contaminant
Summaries for the Fourth Six-Year Review of National Primary Drinking
Water Regulations'' (USEPA, 2024e).
2. Summary of Review Results
Initial Review
After conducting the initial review, as described in section IV.B.1
of this document, EPA identified two chemical contaminants (lead and
copper) with NPDWRs that were considered as part of a recently
completed action, and which are also currently part of an ongoing or
pending regulatory action. EPA published the Lead and Copper Rule
Revisions in January 2021 and published the proposed Lead and Copper
Rule Improvements on December 6, 2023. EPA did not evaluate lead and
copper in Six-Year Review 4 because such effort would be redundant with
these recent and ongoing rulemakings. EPA also identified contaminants
with ongoing or planned EPA health effects assessments. As of December
31, 2021, nine chemical or radiological contaminants reviewed had
ongoing or planned formal EPA health effects assessments. Table 3 of
this document below lists the contaminants with ongoing or planned EPA
assessments at the time of the Six-Year Review 4 cutoff date and the
current status of those reviews. EPA did not conduct a detailed review
of these nine chemical and radiological contaminants under Six-Year
Review 4.
Table 3--Six-Year Review Chemical/Radiological Contaminants With Ongoing
or Planned EPA Health Assessments
------------------------------------------------------------------------
Chemical/radionuclide Status \1\
------------------------------------------------------------------------
Alpha/photon emitters......... EPA Office of Air and Radiation (OAR) is
conducting a review of alpha and beta
photon emitters. Additional information
about this effort can be found at in
the Federal Register (87 FR 15988,
USEPA, 2022a) or at: https://sab.epa.gov/ords/sab/r/sab_apex/sab_bkup/advisoryactivitydetail?p18_id=2616&clear=18&session=8694491614209.
Arsenic....................... Inorganic arsenic is being assessed by
the EPA IRIS Program. The assessment
status can be found at: https://iris.epa.gov/ChemicalLanding/&substance_nmbr=278.
Beta/photon emitters.......... EPA/OAR is conducting a review of alpha
and beta photon emitters. Additional
information about this effort can be
found at in the Federal Register (87 FR
15988, USEPA, 2022a) or at: https://sab.epa.gov/ords/sab/r/sab_apex/sab_bkup/advisoryactivitydetail?p18_id=2616&clear=18&session=8694491614209.
[[Page 59631]]
Chromium VI (as part of total Chromium VI is being assessed by the EPA
Cr). IRIS Program. The assessment status can
be found at: https://iris.epa.gov/ChemicalLanding/&substance_nmbr=144.
Ethylbenzene.................. Ethylbenzene is being assessed by the
EPA IRIS Program. The assessment status
can be found at: https://iris.epa.gov/ChemicalLanding/&substance_nmbr=51.
Mercury....................... Inorganic Mercury Salts is being
assessed by the EPA IRIS Program. The
Assessment status can be found at:
https://iris.epa.gov/ChemicalLanding/&substance_nmbr=1522.
PCBs.......................... PCBs are being assessed by the EPA IRIS
Program. The assessment status can be
found at: https://iris.epa.gov/ChemicalLanding/&substance_nmbr=294.
Radium 226/228................ EPA/OAR is conducting a review of
radium. Additional information about
this effort can be found at in the
Federal Register (87 FR 15988, USEPA,
2022a) or at: https://sab.epa.gov/ords/sab/r/sab_apex/sab_bkup/advisoryactivitydetail?p18_id=2616&clear=18&session=8694491614209.
Uranium....................... Uranium is being assessed by the EPA
IRIS Program. The assessment status can
be found at: https://iris.epa.gov/ChemicalLanding/&substance_nmbr=259.
------------------------------------------------------------------------
\1\ Additional information on the status of EPA IRIS Program assessments
can be found in the EPA IRIS Program Outlooks at https://www.epa.gov/iris/iris-program-outlook.
Regarding the ongoing health assessment for Chromium VI (hexavalent
chromium), on October 20, 2022 the EPA published its draft ``IRIS
Toxicological Review of Hexavalent Chromium [Cr(IV)]'' (87 FR 63774,
USEPA, 2022b). This draft health effects assessment, which includes a
comprehensive evaluation of potential health effects, preliminarily
categorizes hexavalent chromium as likely carcinogenic to humans via
the oral exposure pathway. The final IRIS assessment was not available
as of the publication of this document and for consideration as part of
Six-Year Review 4. When this human health assessment is final, EPA will
carefully review the conclusions and consider all relevant information
to determine whether the NPDWR for chromium is a candidate for
revision.
After the initial review was completed, EPA identified 71 chemical
and radiological NPDWRs that were appropriate for detailed review.
Health Effects
The principal objectives of the health effects assessment review
were to identify: (1) contaminants for which a new health effects
assessment indicates that a change in MCLG might be appropriate (e.g.,
because of a change in cancer classification or an RfD), and (2)
contaminants for which the agency has identified new health effects
information suggesting a need to initiate a new health effects
assessment. For chemicals that were not excluded due to an ongoing or
planned health effects assessment by EPA, a more detailed review was
undertaken. Of the chemicals that underwent a more detailed review, EPA
identified 29 contaminants for which an updated RfD and/or the cancer
risk assessment (from oral exposure) or new relevant non-EPA
assessments might support a change to the MCLG. These 29 chemicals were
further evaluated as part of the Six-Year Review 4 to determine whether
they were candidates for regulatory revision. Table 4 of this document
lists the chemicals with available new health effects information and
the sources of the relevant new information. As shown in this table, 15
chemical contaminants have information that could support a lower MCLG,
and 14 contaminants have new information that could support a higher
MCLG.
Table 4--Chemicals With New Health Assessments That Could Support a
Change in MCLG
------------------------------------------------------------------------
Chemical Relevant new assessment
------------------------------------------------------------------------
15 Contaminants with Potential to Decrease the MCLG
------------------------------------------------------------------------
Antimony............................... CalEPA, 2016.
Cadmium................................ ATSDR, 2012.
Carbofuran............................. USEPA OPP, 2008.
Cyanide................................ USEPA IRIS, 2010b.
cis-1,2-Dichloroethylene............... USEPA IRIS, 2010c.
Endothall.............................. USEPA OPP, 2015b.
Fluoride............................... USEPA OW, 2010d.
Hexachlorocyclopentadiene.............. USEPA IRIS, 2001.
Methoxychlor........................... CalEPA, 2010a.
Oxamyl................................. USEPA OPP, 2017b.
Selenium............................... ATSDR, 2003.
Styrene................................ CalEPA, 2010b.
Toluene................................ Health Canada, 2014.
1,2,4-Trichlorobenzene................. USEPA PPRTV, 2009a.
Xylenes................................ Health Canada, 2014.
------------------------------------------------------------------------
14 Contaminants with Potential to Increase the MCLG
------------------------------------------------------------------------
Alachlor............................... USEPA OPP, 2007a.
Atrazine............................... USEPA OPP, 2018a.
Barium................................. USEPA IRIS, 2005.
Beryllium.............................. USEPA IRIS, 1998.
2,4-Dichlorophenoxy-acetic acid (2,4-D) USEPA OPP, 2017c.
1,2-Dichlorobenzene.................... ATSDR, 2006.
1,4-Dichlorobenzene.................... ATSDR, 2006.
[[Page 59632]]
1,1-Dichloroethylene................... USEPA IRIS, 2002.
Diquat................................. USEPA OPP, 2020b.
Glyphosate............................. USEPA OPP, 2017d.
Lindane................................ USEPA OPP, 2004.
Picloram............................... USEPA OPP, 2020c.
Simazine............................... USEPA OPP, 2018b.
1,1,1-Trichloroethane.................. USEPA IRIS, 2007b.
------------------------------------------------------------------------
Details of the health effects assessment review of the chemical and
radiological contaminants are documented in the ``Results of the Health
Effects Assessment for the Fourth Six-Year Review of Existing Chemical
and Radionuclide National Primary Drinking Water Standards'' (USEPA,
2024f).
Analytical Feasibility
EPA performed analytical feasibility analyses for the contaminants
that reached this portion of the review. These contaminants included
the 15 chemical contaminants identified under the health effects
assessment review as having potential for a lower MCLG. EPA evaluated
whether there were any analytical limitations to lowering the MCL to
the potential MCLG. EPA also evaluated an additional 22 contaminants
with MCLs higher than the current MCLGs due to analytical limitations
at the time of rule promulgation. The document ``Analytical Feasibility
Support Document for the Fourth Six-Year Review of National Primary
Drinking Water Regulations: Chemical Phase and Radionuclides Rules''
(USEPA, 2024g) describes the process EPA used to evaluate whether
changes in PQL are possible in those instances where the MCL may be
limited by analytical feasibility.
Table 5 of this document shows the outcomes of EPA's analytical
feasibility review for two general categories of drinking water
contaminants: (1) contaminants where health effects assessments
indicate potential for lower MCLGs, and (2) contaminants where existing
MCLs were limited by analytical feasibility at the time of promulgation
and new information indicates a potential to reduce the PQL.
A health effects assessment indicates potential for lower
MCLG. This category includes the 15 contaminants identified in the
health effects review as having potential for a lower MCLG. EPA
reviewed the available information to determine if analytical
feasibility could limit the potential for MCL revisions. The current
PQL is not a limiting factor for seven of the 15 contaminants
identified by the health effects review as potential candidates for
lower MCLGs (cis-1,2-dichloroethylene, fluoride,
hexachlorocyclopentadiene, oxamyl, selenium, toluene, and xylenes). For
the remaining eight contaminants, the current PQL is higher than the
potential new MCLG, so EPA evaluated whether there is an opportunity to
lower the PQL. The evaluations indicated that all but one contaminant
(antimony) have potential for a lower PQL, although not to the
potential MCLG. Consequently, analytical feasibility may limit
potential MCL revisions for the remaining seven contaminants (Table 5
of this document).
Existing MCLs are based on analytical feasibility. This
category includes 22 contaminants with existing MCLs that are greater
than the associated MCLGs due to analytical constraints at the time of
rule promulgation. Two of the contaminants (thallium and 1,1,2-
trichloroethane) are non-carcinogenic and have a non-zero MCLG, and the
remaining 20 contaminants are carcinogens with MCLGs equal to zero. EPA
evaluated whether the PQL could be lowered for each of these
contaminants. The evaluations indicated that all but five
(benzo[a]pyrene, DBCP, DEHP, ethylene dibromide, PCBs) of the 22
contaminants evaluated have potential for a lower PQL (Table 5 of this
document).
Where analytical feasibility evaluations indicated the potential
for a PQL reduction, Table 5 of this document lists the type of data
that support this conclusion. The types of data considered include
laboratory proficiency tests (PT), method detection limits (MDL) from
EPA-approved methods, and minimum reporting level (MRL) from the SYR 4
ICR dataset. The methods to evaluate each of these data types to
identify potential to reduce PQLs are described in the analytical
feasibility support document (USEPA, 2024g). Where the evaluations
indicated that the current PQL remained appropriate, Table 5 shows of
this document ``Data do not support PQL reduction.'' EPA found
information supporting potentially lower MCLs for 31 out of 37
contaminants evaluated.
[[Page 59633]]
Table 5--Analytical Feasibility Reassessment Results
------------------------------------------------------------------------
Analytical feasibility
Current PQL reassessment result
Contaminant ([micro]g/L) (and source of new
information) \1\
------------------------------------------------------------------------
15 Contaminants Identified Under the Health Effects Review as Having
Potential for Lower MCLG
------------------------------------------------------------------------
Antimony....................... 6 Data do not support PQL
reduction.
Cadmium........................ 2 PQL reduction supported
(MDL, MRL).
Carbofuran..................... 7 PQL reduction supported
(MDL).
Cis-1,2-dichloroethylene....... 5 PQL not limiting.
Cyanide........................ 100 PQL reduction supported
(MDL).
Endothall...................... 90 PQL reduction supported
(MDL, MRL).
Fluoride....................... 500 PQL not limiting.
Hexachlorocyclopentadiene...... 1 PQL not limiting.
Methoxychlor................... 10 PQL reduction supported
(MDL, MRL, PT).
Oxamyl......................... 20 PQL not limiting.
Selenium....................... 10 PQL not limiting.
Styrene........................ 5 PQL reduction supported
(MDL, MRL, PT).
Toluene........................ 5 PQL not limiting.
Xylenes........................ 5 PQL not limiting.
1,2,4-Trichlorobenzene......... 5 PQL reduction supported
(MDL, MRL, PT).
------------------------------------------------------------------------
22 Contaminants with MCLs Limited by Analytical Feasibility and Higher
than MCLGs
------------------------------------------------------------------------
Benzene........................ 5 PQL reduction supported
(MDL, MRL, PT).
Benzo[a]pyrene................. 0.2 Data do not support PQL
reduction.
Carbon tetrachloride........... 5 PQL reduction supported
(MDL, MRL, PT).
Chlordane...................... 2 PQL reduction supported
(MDL).
1,2-Dibromo-3-chloropropane 0.2 Data do not support PQL
(DBCP). reduction.
1,2-Dichloroethane............. 5 PQL reduction supported
(MDL, MRL, PT).
Dichloromethane................ 5 PQL reduction supported
(MDL, MRL, PT).
1,2-Dichloropropane............ 5 PQL reduction supported
(MDL, MRL, PT).
Di(2-ethylhexyl)phthalate 5 Data do not support PQL
(DEHP). reduction.
Ethylene dibromide............. 0.05 Data do not support PQL
reduction.
Heptachlor..................... 0.4 PQL reduction supported
(MDL).
Heptachlor epoxide............. 0.2 PQL reduction supported
(MDL).
Hexachlorobenzene.............. 1 PQL reduction supported
(MDL, MRL).
Pentachlorophenol.............. 1 PQL reduction supported
(MDL).
PCBs........................... 0.5 Data do not support PQL
reduction.
2,3,7,8-TCDD (dioxin).......... 0.00003 PQL reduction supported
(MRL).
Tetrachloroethylene............ 5 PQL reduction supported
(MDL, MRL).
Thallium....................... 2 PQL reduction supported
(MRL).
Toxaphene...................... 3 PQL reduction supported
(MRL, PT).
1,1,2-Trichloroethane.......... 5 PQL reduction supported
(MDL, MRL, PT).
Trichloroethylene.............. 5 PQL reduction supported
(MDL, MRL, PT).
Vinyl chloride................. 2 PQL reduction supported
(MDL, MRL, PT).
------------------------------------------------------------------------
\1\ The information source codes refer to the method detection limit
(MDL), minimum reporting level (MRL), and proficiency testing (PT)
data analyses. See USEPA (2024g) for further information.
Occurrence and Exposure
Using the SYR 4 ICR database, EPA conducted an assessment to
evaluate national occurrence of regulated contaminants and estimate the
potential population exposed to these contaminants. The details of the
current chemical occurrence analysis are documented in the ``Analysis
of Regulated Contaminant Occurrence Data from Public Water Systems in
Support of the Fourth Six-Year Review of National Primary Drinking
Water Regulations: Chemical Phase Rules and Radionuclides Rules''
(USEPA, 2024h). Based on quantitative benchmarks which were identified
in the health effects and analytical feasibility analyses, EPA
conducted the occurrence and exposure analysis for 31 contaminants.
This analysis shows that 27 of the 31 contaminants assessed rarely
occur at levels above the identified benchmark (e.g., potential MCLG or
PQL). For these 27 contaminants, monitoring results only exceeded
benchmarks in a very small percentage (i.e., less than 0.5 percent) of
systems, which serve a very small percentage of the population,
indicating that revisions to NPDWRs are unlikely to provide a
meaningful opportunity to improve public health protection at the
national level. Therefore, these 27 contaminants were not further
considered as candidates for regulatory revision. The other four
contaminants (cyanide, fluoride, TCE, and PCE) occurred at rates
ranging from 0.57 to 9.1 percent of systems within the SYR 4 ICR
dataset and 3.4 to 6.3 percent of the population served by those
systems. Additional considerations for cyanide, fluoride, TCE, and PCE
are discussed in section V.B.3 of this document. Table 6 of this
document lists the numerical benchmarks used to conduct the occurrence
analysis, the total number of systems with mean concentrations
exceeding a benchmark, and the estimated population served by those
systems. These average concentration-based evaluations are intended to
inform the Six-Year Review, not to assess compliance with regulatory
standards.
[[Page 59634]]
Table 6--Occurrence and Potential Exposure Analysis for Chemical NPDWRs
----------------------------------------------------------------------------------------------------------------
Number (and Population served by
percentage) of systems with a mean
Current MCL Benchmark \1\ systems with a concentration higher
Contaminant (ug/L) (ug/L) mean concentration than benchmark (and
\2\ higher than percentage of total
benchmark population)
----------------------------------------------------------------------------------------------------------------
Contaminants Identified Under the Health Effects Review as Having Potential for Lower MCLG
----------------------------------------------------------------------------------------------------------------
Cadmium............................... 5 1 182 (0.36%) 430,823 (0.16%)
Carbofuran............................ 40 5 \3\ 7 (0.02%) \3\ 49,409 (0.02%)
Cyanide............................... 200 50 328 (0.85%) 8,134,220 (3.43%)
cis-1,2-Dichloroethylene.............. 70 10 7 (0.01%) 42,215 (0.02%)
Endothall............................. 100 50 0 0
Fluoride \4\.......................... 4,000 900 4,479 (9.05%) 17,058,830 (6.30%)
Hexachlorocyclopentadiene............. 50 40 0 0
Methoxychlor.......................... 40 1 1 (<0.01%) 22,536 (0.01%)
Oxamyl................................ 200 9 \3\ 7 (0.02%) \3\ 52,677 (0.02%)
Selenium.............................. 50 30 91 (0.18%) 84,988 (0.03%)
Styrene............................... 100 0.5 89 (0.17%) 27,473 (0.01%)
Toluene............................... 1,000 60 14 (0.03%) 5,256 (<0.01%)
1,2,4-Trichlorobenzene................ 70 0.5 15 (0.03%) 126,201 (0.05%)
Xylenes (total)....................... 10,000 80 23 (0.05%) 34,728 (0.01%)
----------------------------------------------------------------------------------------------------------------
Contaminants with MCLs Higher than MCLGs (Limited by Analytical Feasibility)
----------------------------------------------------------------------------------------------------------------
Benzene............................... 5 0.5 83 (0.16%) 319,633 (0.12%)
Carbon tetrachloride.................. 5 0.5 90 (0.17%) 766,891 (0.28%)
Chlordane............................. 2 1 1 (<0.01%) 240 (<0.01%)
1,2-Dichloroethane.................... 5 0.5 60 (0.11%) 181,041 (0.07%)
Dichloromethane....................... 5 0.5 215 (0.41%) 360,289 (0.13%)
1,2-Dichloropropane................... 5 0.5 41 (0.08%) 34,800 (0.01%)
Heptachlor............................ 0.4 0.1 1 (<0.01%) 900 (<0.01%)
Heptachlor epoxide.................... 0.2 0.1 3 (0.01%) 32,710 (0.01%)
Hexachlorobenzene..................... 1 0.1 6 (0.02%) 17,278 (0.01%)
Pentachlorophenol..................... 1 0.9 0 0
2,3,7,8-TCDD (dioxin)................. 0.00003 0.000005 7 (0.11%) 2,311 (<0.01%)
Tetrachloroethylene (PCE)............. 5 0.5 432 (0.83%) 15,811,810 (5.76%)
Thallium.............................. 2 1 71 (0.14%) 57,541 (0.02%)
Toxaphene............................. 3 1 2 (0.01%) 335 (<0.01%)
1,1,2-Trichloroethane................. 5 3 2 (<0.01%) 50 (<0.01%)
Trichloroethylene (TCE)............... 5 0.5 297 (0.57%) 12,755,926 (4.65%)
Vinyl chloride........................ 2 0.5 24 (0.05%) 307,275 (0.11%)
----------------------------------------------------------------------------------------------------------------
\1\ Benchmark screening levels were set to either potential maximum contaminant level goals (MCLGs) or estimated
quantitation levels (EQLs), depending on the contaminant. For more information see USEPA (2024g).
\2\ Results are based on long-term means generated by substituting one-half the MRL for each non-detection
record. For results based on substituting the value of the full MRL or zero see USEPA (2024h).
\3\ Oxamyl and carbofuran have health endpoints associated with acute exposure and are not appropriate for long-
term mean estimates. Results show the number of systems with at least one detection exceeding the benchmark.
\4\ Estimates represent naturally occurring fluoride concentrations. Quality assurance steps were taken to
exclude samples from fluoridated water systems. See USEPA (2024i) for details.
In addition, EPA performed a source water occurrence analysis for
the 15 chemical contaminants in which updated health effects
assessments indicated the possibility to increase (i.e., render less
stringent) the MCLG values. EPA conducted this analysis to assess for
meaningful opportunity to achieve cost savings while maintaining or
improving the level of public health protection. The data available to
characterize contaminant occurrence was limited because a comprehensive
dataset to characterize drinking water source quality is not available.
Data from the U.S. Geological Survey (USGS) National Water Quality
Assessment program and the U.S. Department of Agriculture Pesticide
Data Program water monitoring survey provide useful insights into
potential contaminant occurrence in source water. The analysis of the
available contaminant occurrence data for potential drinking water
sources indicated relatively low contaminant occurrence in the
concentration ranges of interest, and consequently, no meaningful
opportunity for system cost savings by increasing the MCLG and MCL for
these 15 contaminants. The results of this analysis were documented in
``Occurrence Analysis for Potential Source Waters for the Fourth Six-
Year Review of National Primary Drinking Water Regulations'' (USEPA,
2024j).
Treatment Feasibility
Currently, all of the MCLs for chemical and radiological
contaminants are either (1) set equal to the MCLGs, (2) limited by
analytical feasibility, or (3) set at the level at which health risk
reduction benefits were maximized at a cost justified by the benefits;
none are currently limited by treatment feasibility. EPA considers
treatment feasibility after identifying contaminants with the potential
to lower the MCLG/MCL that constitute a meaningful opportunity to
improve public health. No such contaminants were identified in the
occurrence and exposure analysis described above.
Treatment techniques were promulgated for two of the chemical and
radiological contaminants that were subject to a detailed review in
Six-Year Review 4. Acrylamide and epichlorohydrin occur in drinking
water as treatment impurities and are primarily introduced as residuals
in polymers and copolymers used for water treatment. There are no
standardized analytical methods for their measurement in water; instead
of sampling, water systems must certify to the State in writing that
they use products meeting the specifications in the NPDWR. To evaluate
the potential to revise the NPDWRs for these contaminants, EPA obtained
data from
[[Page 59635]]
NSF on analyses for approval of products against NSF/ANSI Standard 60,
which are based on EPA's regulation. NSF certification data shows that
manufactured products contain acrylamide and epichlorohydrin impurity
levels far below the current regulatory standard. Specifically, the
mean residual acrylamide concentration of certified products is one-
fifth of the current regulatory level and the 90th percentile is one-
half. There were no samples with detections of residual
epichlorohydrin. The available data indicates that the majority of
tested products already pose lower health risks than required under the
current TT, and therefore, revisions are a low priority. EPA is not
listing acrylamide and epichlorohydrin as candidates for revision at
this time. See USEPA (2024k) for details.
Other Regulatory Revisions
In addition to possible revisions to MCLGs, MCLs, and TTs, as a
part of the Six-Year Review 4, EPA considered whether other regulatory
revisions to NPDWRs are needed to address implementation issues, such
as revisions to monitoring and system reporting requirements. EPA used
the protocol to evaluate which implementation issues to consider
(USEPA, 2024c). EPA's protocol focused on items that were not already
being addressed, or had not yet been addressed, through alternative
mechanisms (e.g., as a part of a recent or ongoing rulemaking).
EPA compiled information on implementation-related issues
associated with the Chemical Phase Rules. EPA also identified
unresolved implementation issues and concerns from previous Six-Year
Reviews. The complete list of implementation issues related to the
Phase and Radionuclides Rules is presented in ``Consideration of Other
Regulatory Revisions in Support of the Fourth Six-Year Review of the
National Primary Drinking Water Regulations: Chemical Phase Rules and
Radionuclides Rules'' (USEPA, 2024l).
The agency focused on the following five implementation issues in
the Six-Year Review 4:
Use of an alternative MCL for nitrate in Noncommunity Water
Systems (NCWSs)
Frequency of nitrate monitoring in Transient Noncommunity
Water Systems (TNCWS)
Frequency of nitrite monitoring
Total nitrate-nitrogen plus nitrite-nitrogen MCL
Total cyanide screening for free cyanide
Table 7 of this document provides a brief description of the five
issues and identified potential ways of addressing them. Please see
section V.B.3. of this document for a discussion of these contaminants
and their review outcomes. Please see USEPA (2024l) for a more detailed
description and estimated scope of these issues.
Table 7--Chemical Rule Implementation Issues Identified That Fall Within
the Scope of an NPDWR Review
------------------------------------------------------------------------
Implementation issue Description of issue
------------------------------------------------------------------------
Nitrate Alternative MCL in Non-community Water EPA evaluated the
Systems. possibility of
removing or further
restricting the
options for some
NCWSs to use an
alternative nitrate-
nitrogen MCL of up
to 20 mg/L. The
nitrate-nitrogen
MCL specified for
PWSs in 40 CFR
141.62 is 10 mg/L
and is based on the
critical health
endpoint of
methemoglobinemia
in children under
six months of age.
40 CFR 141.11
provides States the
discretion to use
an alternative MCL
of 20 mg/L for non-
community water
systems (NCWS).
This alternative
MCL is allowed
under certain
conditions--includi
ng that water would
be unavailable to
children under six
months of age.
Monitoring
requirements for
nitrate-nitrogen
are specified in
the introductory
text to 40 CFR
141.23, which
states that ``Non-
transient, non-
community water
systems shall
conduct monitoring
to determine
compliance with the
maximum contaminant
levels specified in
Sec. 141.62 in
accordance with
this section.
Transient, non-
community water
systems (TNCWS)
shall conduct
monitoring to
determine
compliance with the
nitrate and nitrite
MCL in Sec. Sec.
141.11 and 141.62
(as appropriate) in
accordance with
this section.''
Potential concerns
with the current
rule provisions
were identified as:
The
alternative MCL
does not address
any nitrate-
induced health
concerns beyond
methemoglobinemi
a and
While
Sec. 141.11
allows the use
of the
alternative MCL
by all eligible
NCWS, Sec.
141.23 implies
that only TNCWS,
a subcategory of
NCWS, are
eligible to use
the alternative
MCL.
To determine the
scope of this
issue, the agency
reviewed state
drinking water
regulations and
analyzed SYR 4 ICR
nitrate compliance
data and identified
nominal application
of the alternative
nitrate MCL by
NCWSs. In addition,
the nitrate and
nitrite human
health assessments
are currently being
evaluated by the
EPA IRIS program.
An updated
assessment could
inform the
potential health
effects of nitrate
exposure to levels
between 10 and 20
mg/L on adult
populations. EPA
will consider all
available and
updated human
health assessments
as it conducts
future cycles of
the six-year
review.
Nitrate Monitoring Frequency in Transient Currently, community
Noncommunity Water Systems. water systems
(CWSs) and NTNCWSs
are required to
monitor for nitrate
quarterly if a
sample is greater
than or equal to 50
percent of the
nitrate MCL (Sec.
141.23). TNCWSs are
required to monitor
for nitrate
annually (Sec.
141.23(d)(4)). In
the preamble to the
1991 final Phase II
rule, the agency
describes TNCWSs as
being subject to
the quarterly
monitoring
requirement stating
that ``EPA has
decided to retain
the 50 percent
trigger for
increased nitrate
monitoring in the
case of nitrate and
also to extend this
requirement to
TWSs'' (56 FR 3566,
USEPA, 1991).
EPA notes the
conflict between
the regulatory text
and the preamble.
To evaluate whether
it may be
appropriate to
revise the nitrate
NPDWR, the agency
analyzed compliance
monitoring data
collected under the
SYR 4 ICR. EPA
found that while
the majority of
TNCWSs that
reported detections
equal or greater
than 50 percent of
the nitrate MCL did
not conduct
quarterly
monitoring
afterward, the
number of these
systems appears
relatively small.
Due to the limited
scope of this
issue, EPA is not
revising the
monitoring
requirements at
this time but will
consider monitoring
requirements if
NPDWRs are revised
in the future.
[[Page 59636]]
Nitrite Monitoring Frequency...................... According to 40 CFR
141.23(e)(1), all
PWSs were required
to monitor for
nitrite once
between January 1,
1993, and December
31, 1995. If this
initial sample was
less than 50
percent of the MCL
(10 mg/L), systems
``shall monitor at
the frequency
specified by the
State``. Though the
nitrite monitoring
frequency is not
explicitly stated
in the CFR, EPA's
guidance provides
that this frequency
should be at least
once every 9-year
compliance cycle
(USEPA, 2020d). EPA
is aware that some
States may not
require systems to
conduct routine
nitrite monitoring
when sample results
are less than 50
percent of the MCL.
Because sample
results below the
MCL are not
reported to EPA,
the scope of this
issue is uncertain.
To address this
uncertainty, EPA
analyzed State
regulations and
nitrite compliance
monitoring data to
characterize the
frequency of
nitrite monitoring.
Results indicated
that a majority of
systems monitored
for nitrite at
least once during
the last 9-year
compliance cycle
(2011-2019). EPA
intends to work
with States to
encourage more
systems to sample
for nitrite at
least once during
each 9-year
compliance cycle.
Total Nitrate and Nitrite Analysis for Nitrate MCL In 40 CFR 141.62,
Monitoring. the MCL for nitrate
is specified as 10
mg/L and the MCL
for total nitrate
and nitrite is also
specified as 10 mg/
L. Sampling and
analytical
requirements as
specified in 40 CFR
141.23, however,
only included
nitrate and left
total nitrate and
nitrite monitoring
up to the
discretion of
States. Using Safe
Drinking Water
Information System
(SDWIS) compliance
data, EPA is aware
that at least half
of the States allow
total nitrate/
nitrite analysis to
determine
compliance with the
nitrate MCL.
To characterize
monitoring
practices for the
nitrate MCL, the
Agency analyzed Six-
Year Review 4
compliance
monitoring data for
both nitrate and
total nitrate/
nitrite. This
evaluation aims to
serve as a baseline
to assess nitrate
monitoring
practices in the
future, in response
to the 2020 EPA
guidance outlining
best practices when
using total nitrate/
nitrite analysis
for monitoring
compliance with the
nitrate MCL. EPA is
not revising the
monitoring
requirements at
this time but will
consider monitoring
requirements in
Sec. 141.23 if
NPDWRs are revised
in the future, to
incorporate best
practices similar
to those described
in recent guidance
(USEPA, 2020e).
------------------------------------------------------------------------
3. Select NPDWRs With New Information Not Appropriate for Revision
The NPDWRs discussed in this section had new information
identified, but EPA has determined they are not appropriate for
revision at this time due to: (1) data gaps or emerging information
that are necessary for EPA to evaluate as part of a review or; (2) new
information that suggests low or no meaningful opportunity to provide
greater public health protection. Examples of data gaps and emerging
information identified during the review include an analytical
monitoring challenge, a compliance reporting limitation, and an
anticipated health effects assessment being developed by another U.S.
Federal Agency. Specific details about the data gaps and emerging
information identified during the review for on cyanide, fluoride,
nitrate, nitrite, TCE, and PCE are provided below.
Cyanide
EPA published the current MCL and MCLG of 0.2 mg/L (200 [micro]g/L)
for free cyanide on July 17, 1992 (57 FR 31776, USEPA, 1992). In 2010,
EPA published an IRIS assessment (USEPA, 2010b), which identified a new
reproductive health effect endpoint that supports decreasing the MCLG
from 200 [micro]g/L to 4 [micro]g/L. Analytical feasibility information
identified in Six-Year Review 3 and Six-Year Review 4 supports a PQL
reduction to as low as 50 [micro]g/L. In Six-Year Review 3, cyanide was
listed as ``low priority'' due to low occurrence at levels below the
current MCL. Analysis of Six-Year Review 4 occurrence data identified
greater occurrence with 328 systems serving 8.1 million people with
mean concentrations above 50 [micro]g/L (see Table 6 of this document).
However, occurrence was limited to few states (USEPA, 2024h). EPA
considered these occurrence results and the potential for a meaningful
opportunity to improve the level of public health protection.
Two analytical monitoring challenges complicate interpretation of
the occurrence data. As described in section V.B.2 of this document, an
analytical artifact created by ascorbic acid pretreatment of drinking
water samples, which had been disinfected with chloramines, can result
in false positives for free cyanide (USEPA, 2020f). An EPA guidance
document (USEPA, 2020f) identified solutions to address this analytical
challenge, but the general awareness of the availability of this
guidance is uncertain. Second, EPA is aware that some systems analyze
samples for total cyanide, and if the results are lower than the MCL,
these systems report the total cyanide results as free cyanide. Systems
may achieve cost savings by analyzing samples for total cyanide;
however, using results for total cyanide instead of free cyanide could
potentially overestimate the actual occurrence of free cyanide. Free
and total cyanide results cannot be distinguished in the Six-Year
Review 4 ICR dataset because the Safe Drinking Water Information System
(SDWIS) State-version that many primacy agencies use to manage SDWA
compliance monitoring data does not have an analyte code for total
cyanide. Because the numerical benchmark used for occurrence is
significantly lower than the current cyanide MCL, some of the reported
concentrations may be for total cyanide. Therefore, the Six-Year Review
4 occurrence analysis likely overestimates free cyanide occurrence. For
these reasons, EPA does not believe it is appropriate to list the
cyanide NPDWR as a candidate for revision at this time. EPA intends to
help address these data gaps by continuing to disseminate the 2020
guidance on analytical methods for cyanide and may consider an
additional analyte code for total cyanide in the SDWIS reporting
system. Further discussion of the cyanide monitoring issues can be
found in USEPA (2024h).
Fluoride
EPA published the MCL and MCLG of 4.0 mg/L for fluoride on April 2,
1986 (51 FR 11396, USEPA, 1986) based on the critical health endpoint
of crippling skeletal fluorosis. EPA also established a secondary MCL/
MCLG at 2.0 mg/L to protect against cosmetically objectionable dental
fluorosis
[[Page 59637]]
(discoloration and/or pitting of teeth). Certain drinking water systems
may choose to fluoridate finished water as a public health protection
measure for reducing the incidence of cavities. The U.S. Public Health
Service (PHS) recommendation for the optimal community water
fluoridation level is 0.7 mg/L (U.S. Department of Health and Human
Services, 2015). The decision to fluoridate a community water supply is
made by the state or local municipalities and is not required by EPA or
any other federal entity. Fluoride is also added to various consumer
products, such as toothpaste and mouthwash.
EPA has reviewed the NPDWR for fluoride in prior Six-Year Reviews.
As a result of Six-Year Review 1, EPA requested that the National
Research Council (NRC) of the National Academies of Sciences (NAS)
conduct a review of the health and exposure data on orally ingested
fluoride. In 2006, the NRC published the results of its review and
concluded that severe dental fluorosis can be an adverse health effect
(NRC, 2006). The NRC report recommended that EPA develop a dose-
response assessment for severe dental fluorosis as the critical health
endpoint and update an assessment of fluoride exposure from all
sources.
In 2010, EPA published Dose Response Analysis for Noncancer Effects
(USEPA, 2010d), which was considered under Six-Year Review 3. For more
information, please see Appendix C of the Six-Year Review 3 Health
Effects Assessment for Existing Chemical and Radionuclide National
Primary Drinking Water Regulations--Summary Report (USEPA, 2016). In
Six-Year Review 3, EPA did not recommend the fluoride NPDWR for
revisions citing limited agency resources, prioritization of other
contaminants, ongoing health effects research, and other factors that
were anticipated to reduce the U.S. population's exposure to fluoride
via drinking water (82 FR 3531, USEPA, 2017a). In Six-Year Review 4,
EPA again considered the 2010 EPA assessment to derive a lower
potential MCLG of 0.9 mg/L. Review results are provided in section
V.B.2. of this document.
Available published literature on other health effect categories
including neurotoxicity and behavior, reproduction and development,
endocrine effects, and cancer were reviewed in the EPA assessment
(USEPA, 2010d). However, based on the review of the available
literature at the time, EPA determined that the data for these other
health effects associated with fluoride exposure were insufficient to
support their selection as critical effects for potential MCLG
derivation (USEPA, 2010d). EPA is aware of ongoing efforts by the
National Toxicology Program (NTP) to conduct a systematic review and
meta-analysis of the published literature on developmental
neurotoxicity for fluoride. In May 2023, NTP released the Draft ``NTP
Monograph on the State of the Science Concerning Fluoride Exposure and
Neurodevelopmental and Cognitive Health Effects: A Systematic Review''
(NTP, 2023); however, the NTP systematic review and meta-analysis are
not health assessments that could be used to directly inform the
derivation of a potential MCLG. Due to emerging research published on
developmental neurotoxicity after fluoride exposure coupled with
competing workloads and other ongoing high priority actions (see
section V.A of this document.), EPA has decided that the fluoride NPDWR
is not a candidate for revision at this time. In addition, the NTP has
not made a final decision about the report's developmental
neurotoxicity systematic review conclusions and has not formally
released a final report. Following publication of the final NTP report,
EPA will consider the systematic review and meta-analysis conclusions
regarding developmental neurotoxicity to inform the agency's future
development of a health effects assessment for fluoride. See USEPA
(2024f) Appendix B for more information.
Nitrate and Nitrite
EPA published the MCLs and MCLGs for nitrate (10 mg/L) and nitrite
(1 mg/L) based on the critical endpoint of methemoglobinemia (blue baby
syndrome) on January 30, 1991 (56 FR 3526, USEPA, 1991). Nitrate and
nitrite were not reviewed in detail under Six-Year Review 3 due to
ongoing IRIS assessments at that time. Although the development of the
IRIS assessment for nitrate and nitrite was suspended in December 2018,
EPA has restarted development of their health assessment for nitrate
and nitrite as indicated in the October 2023 IRIS Program Outlook. The
agency recently released the ``Protocol for the Nitrate and Nitrite
IRIS Assessment (Oral)'' for public comment on November 9, 2023 (88 FR
77310, USEPA, 2023b). EPA plans to evaluate whether a revision of the
nitrate and nitrite NPDWRs is appropriate, once the final IRIS
assessment is available.
Trichloroethylene (TCE) and Tetrachloroethylene (PCE)
The NPDWR for TCE was published on July 8, 1987 (52 FR 25690,
USEPA, 1987) and the NPDWR for PCE was published on January 30, 1991
(56 FR 3526, USEPA, 1991). Both TCE and PCE are classified as
carcinogens and have MCLGs and MCLs of zero and 5 [micro]g/L,
respectively. The MCLs were based on analytical feasibility at the time
of rule promulgation. TCE and PCE were both listed as candidates for
revision in Six-Year Review 2, based on updated analytical feasibility,
treatment, and occurrence information.
In 2011, EPA announced plans to address a group of regulated and
unregulated carcinogenic volatile organic contaminants (cVOCs) in a
single regulatory effort. The eight regulated contaminants that were
evaluated for the cVOCs group regulation included benzene, carbon
tetrachloride, 1,2-dichloroethane, 1,2-dichloropropane,
dichloromethane, PCE, TCE, and vinyl chloride. In Six-Year Review 3,
these contaminants were categorized under recent, ongoing, or planned
regulatory action and were not reviewed. The cVOC group regulation was
not promulgated, as a result these eight contaminants were reviewed
again during Six-Year Review 4. EPA has determined that TCE and PCE are
no longer candidates for revision at this time based on updated
information.
In Six-Year Review 2, EPA assessed analytical information that
supported reducing the PQL and evaluated occurrence for TCE and PCE at
0.5 [micro]g/L. As shown in Tables 5 and 6 of this document, EPA
identified information in Six-Year Review 4 that again supported
assessing occurrence at that level. The average TCE concentration
exceeded 0.5 [micro]g/L in 297 systems, representing 0.57 percent of
the systems assessed nationwide and serving approximately 13 million
people. Similarly, the average PCE concentration exceeded 0.5 [micro]g/
L in 432 systems, which represent 0.83 percent of the approximately
50,000 PWSs assessed nationwide and serve approximately 16 million
people. These occurrence results are consistent with the Six-Year
Review 2 estimates (75 FR 15500, March 29, 2010, USEPA, 2010a).
The most recent final IRIS assessments for TCE (USEPA, 2011) and
PCE (USEPA, 2012) were completed after the Six-Year Review 2 results
were published and have been selected as the health assessments
relevant to chronic toxicity for TCE and PCE in Six-Year Review 4
(USEPA, 2024f). The updated IRIS assessments maintained the
classification of ``carcinogenic to humans,'' and therefore do not
support a change to the MCLGs of zero for either TCE or PCE. Based on
the Six-Year Review 4 occurrence estimates described above, EPA
considered if there was a potential for an increase in
[[Page 59638]]
human health protection at the lower identified level. To evaluate this
potential, EPA examined the cancer risk level associated with the
current MCLs (5 [micro]g/L) and the screening level (0.5 [micro]g/L)
using updated occurrence and health effects information from Six-Year
Review 4. The cancer risk levels at the current MCLs for TCE and PCE
are 1 x 10-5 (USEPA, 2011) and 3.0 x 10-7 (USEPA,
2012), respectively. These cancer risk levels correspond to excess
lifetime cancer cases of 10 and 0.3 cases per million people,
respectively. At the screening level of 0.5 [micro]g/L, the risk per
million people would be 1 case for TCE and 0.03 cases for PCE. The
implied number of baseline cancer cases over a 70-year exposure period
is unlikely to exceed 120 total cases for TCE and 5 total cases for
PCE. This corresponds to annual averages of 1.7 and 0.07 cases for TCE
and PCE, respectively. This new information identified since Six-Year
Review 2 indicates that revising the MCLs for either TCE or PCE would
result in relatively small health risk reductions among the exposed
population and would divert significant resources from other planned
and ongoing work. Therefore, EPA has determined that TCE and PCE are
considered ``low priority'' and are no longer candidates for revision.
C. Microbial Contaminants Regulations
As discussed in section III of this document, the initial review
branch of the review protocol identifies NPDWRs that have recently been
recently competed or are being reviewed in ongoing or pending
regulatory actions. Excluding such contaminants from a more detailed
review in the Six-Year Review 4 prevents duplicative Agency efforts.
Based on the initial review and considering the ongoing rulemaking
activities for the Microbial and Disinfection Byproduct Rules, EPA did
not perform a more detailed review for the Surface Water Treatment Rule
(SWTR), the Interim Enhanced Surface Water Treatment Rule (IESWTR), the
Long-Term 1 Enhanced Surface Water Treatment Rule (LT1ESWTR), and the
Stage 1 and Stage 2 Disinfectants and Disinfection Byproducts Rules.
The following microbial contaminant regulations were subject to a more
detailed review for the Six-Year Review 4:
Revised Total Coliform Rule (RTCR)
Long Term 2 Enhanced Surface Water Treatment Rule (LT2)
Ground Water Rule (GWR)
Aircraft Drinking Water Rule (ADWR)
Filter Backwash Recycling Rule (FBRR)
Background information on each of the microbial contaminant
regulations is presented in the subsequent sections. EPA is conducting
its first detailed review of the RTCR and the ADWR as part of the Six-
Year Review. The RTCR and the ADWR were excluded from a detailed review
in Six Year Review 3 because they were promulgated in 2013 and 2009,
respectively.
These microbial contaminants regulations establish treatment
technique (TT) requirements in lieu of MCLs, except in the RTCR, EPA
also established an MCL for Escherichia coli (E. coli) and TT
requirements for total coliform. In accordance with the Six-Year Review
Protocol, during the six-year review process, EPA assesses whether new
health risk, analytical methods, or treatment information indicate
possible TT revision. For the RTCR, the regulatory review determines
whether new information indicates potential revision to the MCL for E.
coli.
The elements of the RTCR, LT2, GWR, and ADWR regulations that were
reviewed for Six-Year Review 4 were: health effects, analytical
feasibility, occurrence and exposure, and treatment feasibility. For
the RTCR, LT2, GWR, and ADWR regulations, the EPA did not find any new
relevant information as it relates to analytical feasibility. For all
the other elements reviewed a summary of the findings is included in
the subsequent sections. In addition, detailed information about the
review is provided in the ``Six-Year Review 4 Technical Support
Document for Microbial Contaminant Regulations'' (USEPA, 2024m).
At this time, none of the reviewed microbial contaminant rules are
being identified as a candidate for regulatory revision.
1. Revised Total Coliform Rule
Background
EPA promulgated the Revised Total Coliform Rule (RTCR), a revision
to the Total Coliform Rule, on February 13, 2013 (78 FR 10269, USEPA,
2013). The Total Coliform Rule (TCR) was promulgated on June 29, 1989
(54 FR 27544, USEPA, 1989). The purpose of the revision was to increase
public health protection through the reduction of potential entry
pathways for fecal contamination into distribution systems. The TCR
required all public water systems (PWSs) to monitor for the presence of
total coliforms and Escherichia coli (E. coli)) in the distribution
system at a frequency dependent on the size (population served by) of
the system. Under the TCR, a maximum contaminant level (MCL) was
established based on the presence or absence of total coliforms with
the intent to address contamination that could enter into distribution
systems. The RTCR revised the TCR to eliminate the MCL for total
coliforms and established an MCLG and MCL for E. coli of zero. The RTCR
also requires PWSs that have an indication of coliform contamination
(e.g., as a result of total coliform positive samples, E. coli MCL
violations or performance failure) to find and assess the problem,
identify sanitary defects and take corrective action. There are two
levels of assessments (i.e., Level 1 and Level 2) based on the severity
or frequency of the problem.
Summary of Review Results
Information available for national occurrence and exposure
indicates that both routine total coliform and E. coli positive rates
have decreased after the implementation of RTCR. EPA concludes that no
regulatory revisions to the RTCR are appropriate at this time based on
the review of available information.
Health Effects
Collier et al. (2021) estimated the collective U.S. disease burden
attributable to over a dozen waterborne illnesses from infectious
pathogens found in the distribution system (vibriosis,
campylobacteriosis, cryptosporidiosis, giardiasis, Legionnaire's
disease, salmonellosis, shigellosis, infections by non-tuberculous
mycobacteria (NTM), norovirus, Shiga-toxin-producing E. coli, otitis
externa, pneumonia, and septicemia). These researchers estimated the
total disease burden at approximately 7.15 million cases annually, with
an estimated 118,000 hospitalizations and 6,630 deaths. In this
analysis, waterborne disease is understood to include gastrointestinal,
respiratory, and systemic disease attributable to both drinking-water
and non-drinking-water exposure. From further evaluation of this
study's cases, Gerdes et al. (2023) determined 1.13 million of these
illnesses were attributable to drinking water. According to the
estimates presented in these studies, the opportunistic pathogens
(Legionella, Nontuberculous Mycobacteria (NTM), and Pseudomonas) impose
a greater public health burden than the fecal pathogens. Of the
estimated 7.15 million infectious waterborne illnesses in 2014 in the
United States, drinking water exposure caused 40 percent of
hospitalizations and 50 percent of deaths.
[[Page 59639]]
Occurrence and Exposure
To evaluate potential pathogenic contamination in distribution
systems EPA analyzed national compliance monitoring data from the SYR 4
ICR dataset (USEPA, 2019. EPA assessed the trends that may be
associated with the implementation of the RTCR and found a
statistically significant decline for total coliform positive results
from years of 2014-2015 to 2018-2019 (i.e., before and after the
implementation of RTCR respectively). The result suggests that the
presence of these indicator organisms in the distribution system was
declining. The trend of declining positive total coliform results was
observed across different types of public water systems, water sources
(ground water versus surface water), and system sizes (small versus
large). With respect to the fecal contamination indicator E. coli, the
observed decreasing trend was not supported by a statistical test of
significance. EPA also found that the absolute number of E. coli
positives were low, suggesting that the treatment techniques are
effective (USEPA, 2024m).
Treatment Feasibility
In this section as part of Six-Year Review process, EPA evaluated
new information about tools and treatment techniques. Since the major
treatment technique requirements under the RTCR are assessments
followed by corrective actions (if total coliform and/or E. coli are
detected), EPA evaluated the effectiveness of such requirements by
comparing total coliform and E. coli positive rates after completion of
either Level 1 or Level 2 assessments (USEPA, 2024m).
EPA found about an 80 percent decrease in both routine total
coliform and E. coli positive rates, two months after completion of
RTCR assessments for systems having a monthly monitoring schedule.
These analytical results and newly compiled information suggest
that the ``find and fix'' approach prescribed under the provisions of
assessments and corrective action within RTCR appears to work as
intended for reducing the microbial occurrence in distribution systems
and may be improving public health protection from microbial risks (as
indicated by a substantial drop of the total coliform and E. coli
positive rates following completion of corrective actions to respond to
assessments).
2. Long Term 2 Enhanced Surface Water Treatment Rule
Background
EPA promulgated the Long Term 2 Enhanced Surface Water Treatment
Rule, hereafter referred to as ``LT2'', on January 5, 2006 (71 FR 654,
USEPA, 2006a). The LT2 applies to all PWSs that use surface water or
ground water under the direct influence of surface water. The LT2
builds upon the IESWTR and the LT1 by improving control of microbial
pathogens and by focusing on systems with elevated Cryptosporidium
contamination risk. The purposes of the LT2 are to protect public
health from illness arising from exposure to Cryptosporidium and other
microbial pathogens in drinking water and to prevent significant
increases in risks that might occur when systems implement drinking
water disinfection byproduct rules.
Key provisions in the LT2 include: source water monitoring for
Cryptosporidium (with a screening procedure to reduce monitoring costs
for small systems); risk-targeted Cryptosporidium treatment by filtered
systems with the highest source water Cryptosporidium levels;
inactivation of Cryptosporidium by all unfiltered systems; criteria for
the use of Cryptosporidium treatment and control processes; and
covering or treating uncovered finished water storage facilities.
The LT2 requires PWSs using surface water or ground water under the
direct influence of surface water to monitor their source waters for
Cryptosporidium and/or E. coli to identify additional treatment
requirements. PWSs must monitor their source water (i.e., the influent
water entering the treatment plant) over two different timeframes
(defined as Round 1 and Round 2) to determine the occurrence of
Cryptosporidium. Monitoring results determine the extent of
Cryptosporidium treatment requirements under the LT2. According to the
LT2 rule requirements, all PWSs were to complete Round 2 by 2021. To
reduce monitoring costs, small filtered PWSs (serving fewer than 10,000
people) which initially monitor for E. coli for one year as a screening
analysis, are required to monitor for Cryptosporidium only if their E.
coli levels exceed specified trigger values. Small filtered PWSs that
exceed the E. coli trigger, as well as small unfiltered PWSs, must
monitor for Cryptosporidium for one or two years, depending on the
sampling frequency. The LT2 also requires all unfiltered PWSs to
provide at least 2 to 3-log (i.e., 99 to 99.9 percent) inactivation of
Cryptosporidium. Further, under the LT2, unfiltered PWSs must achieve
their overall inactivation requirements (including Giardia lamblia and
virus inactivation as established by earlier regulations) using a
minimum of two disinfectants.
Under the LT2, PWSs with uncovered finished water reservoirs
(UCFWR) must either cover the storage facility or treat the water
leaving the storage facility to achieve inactivation and/or removal of
4-log virus, 3-log Giardia lamblia and 2-log Cryptosporidium using a
protocol approved by the state (USEPA, 2006a). Most finished water
reservoirs for surface water systems are covered. All PWSs with UCFWRs
are under administrative orders or compliance agreements to cover or
treat their UCFWR.
Summary of Review Results
From a review of the literature on Cryptosporidium health effects,
EPA concludes that there is no new health information to suggest a need
to modify the LT2. In addition, EPA determined that no regulatory
revisions to the microbial toolbox options are appropriate at this
time. During Six-Year Review 4, EPA did not consider disinfection
profiling information since EPA is evaluating overall filtration and
disinfection requirements in the SWTRs as part of the on-going
consideration of potential revisions to the MDBP rules. For more
information regarding EPA's review of treatment feasibility see the
``Six-Year Review 4 Technical Support Document for Microbial
Contaminant Regulations'' (USEPA, 2024m).
Health Effects
Since 1995, cryptosporidiosis has been a nationally notifiable
disease, meaning healthcare providers and laboratories that diagnose
cases of laboratory-confirmed cryptosporidiosis are required to report
cases to their local or state health departments, which in turn report
the cases to CDC. Since 2012, there have been four reported outbreaks
of cryptosporidiosis from public water systems to CDC. The four
outbreaks together resulted in a total of 201 recorded illnesses, 2
hospitalizations, and no deaths (CDC, 2022). Although cryptosporidiosis
is a nationally notifiable disease, additional outbreaks may go
unreported to CDC or may have been recorded as of uncertain causes. In
addition, since CDC's National Outbreak Reporting System is
specifically focused on outbreaks, it does not capture rates of endemic
disease of cryptosporidiosis from drinking water.
[[Page 59640]]
Occurrence and Exposure
Based on the LT2 source water monitoring results, filtered systems
were classified in one of four risk categories (Bins 1-4) to determine
additional treatment needed. Systems in Bin 1 are not required to
provide additional Cryptosporidium treatment. Systems in Bins 2-4 must
achieve 1.0-2.5 log of treatment (i.e., 90 to 99.7 percent reduction
for Cryptosporidium) over and above that provided by conventional
treatment, depending on the Cryptosporidium concentrations. Filtered
PWSs must meet the additional Cryptosporidium treatment requirements in
Bins 2, 3, or 4 by selecting one or more technologies from the
microbial toolbox to ensure source water protection and management,
and/or Cryptosporidium removal or inactivation. All unfiltered water
systems must provide at least 99 or 99.9 percent (2 or 3-log)
inactivation of Cryptosporidium, depending on their monitoring results.
All filtered systems that provide 5.5 log treatment for Cryptosporidium
are exempt from monitoring and subsequent bin classification.
Six years after the initial bin classification following a first
round of monitoring, filtered systems were required to conduct a second
round of monitoring. Round 2 monitoring began in 2015. Round 2
monitoring was implemented to understand year-to-year variability for
occurrence of Cryptosporidium. The difference observed between
occurrence at the time of the ICR Supplemental Surveys and the LT2
Round 1 monitoring indicates year-to-year variability (USEPA, 2017a).
Limited occurrence data for Cryptosporidium was available to EPA in
response to the SYR 4 ICR since fewer than 1 percent of the
Cryptosporidium monitoring records provided actual concentration levels
with units of oocysts/L; however, the data about system binning for
about 300 PWSs serving populations larger than 10,000 was provided.
Those data indicate that the percentage of PWSs potentially moving to
an ``action bin'' based on Round 2 monitoring would not be
substantially higher than the percentage estimated based on modeling
conducted during the LT2 review included as part of the Six-Year Review
3, thus suggesting no change to the review decision made under Six-Year
Review 3.
Treatment Feasibility
The LT2 includes a variety of treatment and control options,
collectively termed the ``microbial toolbox,'' that PWSs can implement
to comply with the LT2's additional Cryptosporidium treatment
requirements. Most options in the microbial toolbox carry prescribed
credits toward Cryptosporidium treatment and control requirements. The
LT2 Toolbox Guidance Manual (USEPA, 2010e) provides guidance on how to
apply the toolbox options.
For the Six-Year Review 4, EPA reviewed additional research into
the relationship between ultraviolet light (UV) dose and log
inactivation. Some studies showed the same log inactivation at UV doses
lower than those reported in previous EPA guidance, and other studies
showed log inactivation at UV doses higher than those contained in the
guidance. Since there is not a consensus of log inactivation at levels
significantly lower than EPA prior published guidance, EPA concludes
that the new information does not support changes to the UV dose table.
EPA also reviewed new information pertaining to technologies, which
have not been included in the existing LT2 toolbox guidance manual, and
which may be effective for the removal or inactivation of protozoa
including Cryptosporidium. In addition, EPA also reviewed new
technologies that water systems may be employing to improve treatment
performance for complying with the MDBP rules, e.g., turbo coagulation
and powdered activated carbon. Initiatives by states and EPA's Area
Wide Optimization Program were evaluated as well. EPA found that this
new information appears insufficient to develop quantification criteria
for inactivation and removal credit for Cryptosporidium.
3. Ground Water Rule
Background
EPA promulgated the Ground Water Rule (GWR) in 2006 (71 FR 65574,
USEPA, 2006b) to provide protection against microbial pathogens in PWSs
using ground water sources. The rule establishes a risk-based approach
to target undisinfected ground water systems that are vulnerable to
fecal contamination. In addition to the protection provided by the RTCR
and GWR monitoring requirements, systems that do not disinfect are also
protected by the sanitary survey provisions of the GWR and the
treatment technique provisions of the RTCR.
The GWR required compliance beginning December 1, 2009. Since the
triggered source water monitoring provision was built upon the
compliance monitoring results of total coliform and E. coli under the
TCR and later RTCR, implementation of the GWR was not yet completed for
the period of time covered by the Six-Year Review 3 ICR (2006-2011).
The RTCR was promulgated in 2013 and became effective on April 1, 2016.
EPA expected that implementation of the RTCR might impact the percent
of ground water systems that would be triggered into source water
monitoring and taking any corrective actions under the GWR. Therefore,
the effects of the GWR and the RTCR implementation in addressing
vulnerable ground water systems were not reviewed during the Six-Year
Review 3 process.
Summary of Review Results
The information considered during this review suggest that
microbial pathogens have been detected in untreated ground water
samples which show no presence of fecal indicators, however these
studies are limited in quantity and the prevalence of endemic disease
from microbial contamination of untreated ground water cannot be well
characterized with the available information (USEPA, 2024m). Additional
and more robust studies are needed to further understand the magnitude
of the issue. EPA concludes that no regulatory revisions to the GWR are
appropriate at this time.
Health Effects
Waterborne pathogens can cause mild to severe illnesses (Wallender
et al., 2014). These illnesses may include; acute gastrointestinal
illness (AGI) with diarrhea, abdominal pain/discomfort, nausea,
vomiting, conjunctivitis, aseptic meningitis, and hand-foot-and-mouth
disease. Infections from some waterborne pathogens (e.g.,
Campylobacter) may cause long-term implications, such as reactive
arthritis, Guillain-Barr[eacute] syndrome, and irritable bowel syndrome
(Keithlin et al., 2014). Other more severe illnesses include hemolytic
uremic syndrome (HUS) (kidney failure), hepatitis, and bloody diarrhea
(WHO, 2004).
Some studies have indicated that waterborne pathogens such as
adenovirus, enteroviruses, hepatitis A, norovirus, rotavirus,
Salmonella, Giardia, Cryptosporidium, and Shigella have been found in
untreated ground water samples (Borchardt et al., 2012; Wallender et
al., 2014; Stokdyk et al., 2020).
Human enteric viruses have been detected in drinking water free of
bacterial indicators, such as total coliform. With total coliform
detections rates similar to the average rate for
[[Page 59641]]
undisinfected community PWSs in the U.S, Borchardt et al. (2012)
estimated a six to 22 percent attributable risk for enteric illness
from viruses present in the communities' drinking water. In another
study, Burch et al. (2022) found that noncommunity wells had higher
infection risk than community wells. Burch et al. (2022) found the
annual risk was relatively high for all pathogens combined in the
study, while the average daily doses for individual pathogens were low,
indicating that significant risk results from sporadic pathogen
exposure. Studies by Fout et al. (2017) and Stokdyk et al. (2020) found
that total coliform (and other indicators like E. coli, somatic phage,
HF183, and Bacteroidales-like HumM2) tend to have high specificity,
meaning that absence of the indicator provides relatively strong
assurance that water is free of viral and other pathogens, but also
have low sensitivity, meaning that presence of the indicator does not
necessarily predict presence of pathogens.
Occurrence and Exposure
Similar to the RTCR, EPA examined the national compliance
monitoring data collected for the Six-Year Review 4 to understand how
total coliform and E. coli, indicators of contamination behaved before
and after implementation of the GWR, as well as understanding how level
of contamination for high risk undisinfected ground water systems have
changed.
As noted, GWR monitoring is based on initial monitoring under the
RTCR. If a system has a positive total coliform sample (based on
routine coliform monitoring under the RTCR), the system must test that
sample for the presence of E. coli. Under the GWR, ground water systems
that do not provide at least 4-log treatment of viruses and are
notified of a routine positive total coliform sample collected under
RTCR must collect and analyze at least one source water sample for E.
coli or other fecal indicators from each ground water source (well)
within 24 hours. If the triggered source water sample has a positive
for E. coli the ground water systems must take corrective action. EPA
conducted a distribution system total coliform/E. coli data exploration
and analysis effort to identify findings that could inform the risk
reduction of the fully implemented GWR, as well as characterize high
risk systems.
The national average total coliform and E. coli rates (i.e., total
number of positives divided by total number of samples) before and
after implementation of the GWR were calculated using Six-Year Review 3
and Six-Year Review 4 datasets. The analytical results were grouped by
system sizes and disinfection status (i.e., disinfecting versus and
undisinfected). The period of analysis was from 2007-2008 (before the
GWR was implemented) to 2014-2015 (after the completed implementation
of the first round of sanitary surveys under the GWR). The total
coliform rates across different system categories decreased, suggesting
that there may be less pathogenic contamination pathways and so
potentially less microbial exposure, corresponding to the period when
the GWR was being implemented. This downward change is supported by a
statistical significance test. The declining count of the fecal
contamination indicator, E. coli was not supported by a test of
statistical significance. Yet numbers of E. coli positives were
consistently low, which may indicate low exposure to fecal
contamination.
EPA performed a more specific analysis using a statistical model
focused on the most vulnerable water systems, the undisinfected ground
water systems. EPA conducted statistical modeling focused on
examination of total coliform levels in small ground water systems to
account for their infrequent sampling and relatively low level of
monitoring observations compared to larger systems that monitor more
frequently.
There are approximately 45,000 undisinfected ground water systems
associated with total coliform records collected and less than 1
percent population among the population served by the public community
water systems in the U.S. (based on SYR 4 ICR data). Most undisinfected
ground water systems serve small permanent populations or transient
populations.
EPA found that the smallest systems (serving a population fewer
than 1,001) have higher median total coliform rates than undisinfected
larger systems. In addition, the analysis indicates that median
occurrence rates for many undisinfected transient systems may have
fallen, from four to three percent total coliform detection rate from
2011 to 2019. Another finding from the statistical modeling is that the
number of non-community systems that have high total coliform
detections in the systems serving fewer than 1,001 people has remained
roughly the same, about 7,000 undisinfected ground water systems, when
running a comparison using Six-Year Review 3 and Six-Year Review 4 ICR
data with a threshold of five percent rate of total coliform positive
detections, which is the threshold that triggers a Level 1 Assessment
in the RTCR. For statistical analysis of E. coli detection rates, there
was not sufficient data to make estimates of averages and numbers of
systems exceeding high levels.
Two implications of these modelling results should be noted as it
relates to estimating potential exposure and occurrence. One is that
the non-community systems serving fewer than 1,001 have total coliform
positive rates around two to four percent, while a study of 14
community systems served by untreated ground water in Wisconsin found
that a total coliform positive rate of 2.3 percent was associated AGI
burden (Borchardt et al, 2012). EPA concludes, however, that studies
indicating microbial disease burden at total coliform positive levels
found in high-risk systems are limited in number as mentioned in the
Health Effects section, as well as in geographic scope. Another
implication from the results of this statistical analysis is that the
remaining systems with very high total coliform rates could suggest
compliance challenges among small ground water systems.
In addition to evaluating trends with indicators under RTCR to
evaluate protection for vulnerable ground water systems, EPA also
considered the results from the GWR requirement for triggered source
water sampling. The sample results indicate that there is a small
percent of positive source water E. coli detections ranging from 0.76
percent to 1.99 percent of E. coli samples for non-community systems
which are primarily undisinfected systems, and 250 out of 270 of source
water E. coli detections were associated with undisinfected systems
serving fewer than 500 people. The other fecal indicators, coliphage
and enterococci were used very infrequently, and data was insufficient
to evaluate. Low incidence of fecal indicators may indicate low
exposure to fecal contamination among undisinfected ground water
systems.
Treatment Feasibility
Per treatment technique requirements under the GWR, there are two
scenarios that trigger ground water systems to take corrective actions:
(1) positive results of the triggered source water monitoring, and (2)
significant deficiencies found during Sanitary Survey (EPA was not able
to assess sanitary surveys directly given data limitations). EPA
evaluated whether treatment was improving under the GWR by using the
RTCR occurrence analysis data to consider total coliform rates before
and after the GWR was implemented.
[[Page 59642]]
EPA developed a systematic approach to identify disinfection status
of ground water systems for each of the years included in the Six-Year
Review ICR datasets and found that the percentage of ground water
systems that were disinfecting had increased consistently from 2007-
2008 (before the GWR was implemented) to 2014-2015. This finding of an
increasing number of systems disinfecting could be attributable to
systems taking corrective actions to address positive results after
triggered source water monitoring. The analytical results presented in
the ``Six-Year Review 4 Technical Support Document for Microbial
Contaminant Regulations'' (USEPA, 2024m) also indicate that
disinfecting ground water systems had substantially lower total
coliform positive rates than undisinfected ground water systems. In
addition, EPA also observed that the total coliform positive rates
decreased after completion of the first round of sanitary surveys under
the GWR among ground water systems.
4. Aircraft Drinking Water Rule
Background
EPA promulgated the Aircraft Drinking Water Rule (ADWR) on October
19, 2009 (74 FR 53590, USEPA, 2009b). The primary purpose of the ADWR
is to ensure that safe and reliable drinking water is provided to
aircraft passengers and crew. This entails providing air carriers with
a feasible way to comply with SDWA and NPDWRs. The existing NPDWRs were
designed for traditional, stationary public water systems not mobile
aircraft water systems that are operationally different. For example,
aircraft fly to multiple destinations throughout the course of any
given day and may board drinking water from sources at any of these
destinations. Aircraft board water from airport watering points via
temporary connections. Aircraft drinking water safety depends on a
number of factors including the quality of the water that is boarded
from these multiple sources, the care used to board the water, and the
operation and maintenance of the onboard water system and the water
transfer equipment.
The ADWR's provisions protect against disease-causing
microbiological contaminants through the required development and
implementation of aircraft water system operations and maintenance
plans. The ADWR's provisions include: routine disinfection and flushing
of the water system, air carrier training requirements for key
personnel, and periodic sampling of the onboard drinking water, as well
as self-inspections of each aircraft water system and immediate
notification of passengers and crew when violations or specific
situations occur.
Summary of Review Results
The ADWR is a unique rule within the context of the SDWA. This rule
applies only to aircraft engaged in interstate commerce with onboard
systems that provide water for human consumption through pipes. These
aircraft water systems board finished water for human consumption and
regularly serve an average of at least twenty-five individuals daily,
at least 60 days out of the year. Human consumption includes water for
drinking, hand washing, food preparation, and oral hygiene. From a
review of available technical information within the scope of the
review, EPA concludes that there is no new information to suggest that
regulatory revisions to the ADWR are appropriate at this time.
Health Effects
Limited new literature is available on the presence of microbial
pathogens in aircraft drinking water. Handschuh et al. (2015) found
that long-haul flights were significantly poorer in terms of microbial
water quality than short haul flights. A follow-up study by Handschuh
et al. (2017) demonstrated that there is a diversity of microorganisms
within the aircraft drinking water supply chain.
Other studies have also found microbial contaminants present in
aircraft drinking water, including Pseudomonas aeruginosa, enterococci,
clostridia, and Salmonella (WHO, 2009; Schaeffer et al., 2012).
Tracking an illness back to contaminated water served on an aircraft
presents a technical challenge. Most disease incubation periods are
longer than the duration of a flight, and even if it is possible to
determine that a disease was incurred in air travel, it may be
difficult to determine if the route of transmission was from beverages,
food, or close proximity of people, and to determine whether
transmission happened on board the aircraft or at an air terminal.
Occurrence and Exposure
The Aircraft Reporting and Compliance System (ARCS) is used to
facilitate the reporting of aircraft water system data under the ADWR.
Air carriers subject to the ADWR must report to EPA about their
inventory of aircraft water system fleet; the date the operations and
maintenance plan was developed; the date the coliform sampling plan was
developed; the date the aircraft water system sampling plan(s) was
incorporated into the aircraft water system Operations and Maintenance
plan; the date the Operations and Maintenance plan(s) was incorporated
into the U.S. Federal Aviation Administration (FAA) accepted air
carrier Operation and Maintenance program; the frequency for routine
disinfection and flushing, and the corresponding routine total coliform
sampling frequency; and the date for routine disinfection and flushing,
routine coliform sampling dates and results, and corrective actions
(when applicable).
For Six-Year Review 4, EPA downloaded and reviewed compliance
monitoring data available in ARCS as of May 2021. Approximately 140,000
records of aircraft water systems compliance monitoring data for total
coliform and E. coli samples were available in ARCS from February 2011
through May 2021, including results reported for more than 70 different
makes/models of aircraft. These results were used to characterize the
positivity rates of total coliform and E. coli in aircraft water
systems on an annual basis for the years that data were available
(2011-2021) and for the subset of years 2012 through 2019. This
approach removes potentially confounding considerations associated with
evaluating data for calendar year 2020 when a large number of aircraft
PWS were inactive due to COVID-19, as well as years 2011 and 2021 for
which the ARCS data evaluated represents partial years.
Monitoring data broken down by year for the years 2012-2019 shows
an average annual total coliform positivity rate of 5.46 percent, with
a median of 5.63 percent, a minimum of 3.76 percent and a maximum of
7.03 percent. The total coliform positivity rate decreased on an annual
basis from 2012-2019. The average E. coli positivity rate was 0.26
percent, and the median rate was also 0.26 percent, with a minimum of
0.17 percent and a maximum of 0.33 percent. The E. coli positivity rate
also decreased on an annual basis.
Treatment Feasibility
Under the ADWR, air carriers routinely disinfect and flush aircraft
water systems at the frequency recommended by the water system
manufacturer or, if not specified by the manufacturer, they may choose
from one of four options. If corrective disinfection and flushing is
chosen or required, air carriers follow the procedures in their O&M
plans. Unscheduled flight disruptions to
[[Page 59643]]
perform corrective disinfection and flushing can be minimized by
shutting off the water or preventing the flow of water to the taps.
Before allowing unrestricted access to the aircraft water system, a
complete set of follow-up samples must be collected and submitted for
analysis after the disinfection and flushing event if triggered by a
total coliform-positive sample and must be reported as total coliform-
negative if triggered by an E. coli-positive sample. One study was
identified that examined the effectiveness of disinfection and flushing
procedures to prevent coliform persistence in aircraft water systems
(Szabo et al., 2019). That study showed that coliforms were not
persistent on the aircraft plumbing surfaces, and coliforms were not
detected after disinfection and flushing. However, it noted an
exception for the aerator installed in the lavatory faucet which was
coliform positive after disinfection with ozone and mixed oxidants;
disinfection with glycolic acid and quaternary ammonia showed no
detectable coliforms on aerators after 30 minutes of soaking in the
disinfectants.
Each aircraft water system must be inspected by the air carrier at
least every 5 years according to the procedures in their O&M plans. At
a minimum, the self-inspection procedures for an aircraft water system
must include inspection of the storage tank, distribution system,
supplemental treatment, fixtures, valves, and backflow prevention
devices. Any deficiencies detected must be addressed, and any
deficiency that is unresolved within 90 days of identification of the
deficiency must be reported to EPA.
5. Filter Backwash Recycling Rule
EPA promulgated the Filter Backwash Recycling Rule (FBRR) on June
8, 2001 (66 FR 31086, USEPA, 2001a). The rule aimed to increase public
health protection by addressing microbial contaminant risks associated
with filter backwash recycling practices. The rule required certain
systems to return recycled filter backwash water, sludge thickener
supernatant, and liquids from dewatering processes to a location in the
system such that all filtration processes of a system are employed, or
at an alternate location if approved by the State. In addition, the
rule required systems that employ conventional filtration or direct
filtration to notify States of their recycling practices by June 8,
2004, and after then to keep and retain records on file about their
recycle flows for subsequent review and evaluation by the State. There
are no ongoing monitoring requirements associated with the FBBR.
EPA reviewed available State data collected under the ICR; however,
the EPA did not identify any new and relevant information that would
indicate that revisions to the NPDWR at this time are appropriate.
VI. References
ATSDR. 2003. Toxicological Profile for Selenium. Atlanta, GA: U.S.
Department of Health and Human Services, Public Health Service,
Agency for Toxic Substances and Disease Registry (ATSDR). https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/2990677
ATSDR. 2006. Toxicological Profile for Dichlorobenzenes. Atlanta,
GA: U.S. Department of Health and Human Services, Public Health
Service, Agency for Toxic Substances and Disease Registry (ATSDR).
https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/5160103
ATSDR. 2012. Toxicological Profile for Cadmium. Atlanta (GA): U.S.
Department of Health and Human Services, Public Health Service,
Agency for Toxic Substances and Disease Registry (ATSDR). https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/2509015
Borchardt, M.A., S.K. Spencer, B.A. Kieke, Jr., E. Lambertini, and
F.J. Loge. 2012. Viruses in Nondisinfected Drinking Water from
Municipal Wells and Community Incidence of Acute Gastrointestinal
Illness. Environmental Health Perspectives, 120(9): 1272-1279.
Burch T.R., J.P. Stokdyk, N. Rice, A.C. Anderson, J.F. Walsh, S.K.
Spencer, A.D. Firnstahl and M.A. Borchardt. 2022. Statewide
Quantitative Microbial Risk Assessment for Waterborne Viruses,
Bacteria, and Protozoa in Public Water Supply Wells in Minnesota.
Environmental Science & Technology. 56(10): 6315-6324.
CalEPA. 2010a. Public Health Goal for Methoxychlor in Drinking
Water. EPA-HQ-OW-2016-0627-0033. Sacramento, CA: California
Environmental Protection Agency (CalEPA), Office of Environmental
Health Hazard Assessment. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10489852
CalEPA. 2010b. Public Health Goal for Styrene in Drinking Water.
Sacramento, CA: California Environmental Protection Agency (CalEPA),
Office of Environmental Health Hazard Assessment. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10489854
CalEPA. 2016. Public Health Goal for Antimony in Drinking Water:
2016 Update. Sacramento, CA: California Environmental Protection
Agency (CalEPA), Office of Environmental Health Hazard Assessment.
https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10489864
Centers for Disease Control and Prevention (CDC). 2022. National
Outbreak Reporting System Dashboard. Atlanta, Georgia: U.S.
Department of Health and Human Services, CDC. Accessed November
2022. Available from URL: wwwn.cdc.gov/norsdashboard.
Collier, S.A., L. Deng, E.A. Adam, K.M. Benedict, E.M. Beshearse,
A.J. Blackstock, B.B Bruce, G. Derado, C. Edens, K.E. Fullerton and
J.W. Gargano. 2021. Estimate of burden and direct healthcare cost of
infectious waterborne disease in the United States. Emerging
Infectious Diseases. 27(1): 140.
Fout, G.S., M.A. Borchardt, B.A. Kieke Jr., and M.R. Karim. 2017.
Human virus and microbial indicator occurrence in public-supply
groundwater systems: meta-analysis of 12 international studies.
Hydrogeology Journal. 25(4): 903.
Gerdes, M.E., S. Miko, J.M. Kunz, E.J. Hannapel, M.C. Hlavsa, M.J.
Hughes, M.J. Stuckey, L.K.F. Watkins, J.R. Cope, J.S. Yoder, V.R.
Hill, and S.A. Collier. 2023. Estimating Waterborne Infectious
Disease Burden by Exposure Route, United States, 2014. Emerging
Infectious Diseases. 29(7): 1357.
Health Canada. 2014. Guidelines for Canadian Drinking Water Quality.
Guideline Technical Document. Toluene, Ethylbenzene and Xylenes.
Ottawa, Ontario: Health Canada. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/3049488
Handschuh, H., J. O'Dwyer, and C.C. Adley. 2015. Bacteria that
travel: the quality of aircraft water. International Journal of
Environmental Research and Public Health, 12(11): 13938-13955.
Handschuh, H., M.P. Ryan, J. O'Dwyer and C. C. Adley. 2017.
Assessment of the bacterial diversity of aircraft water:
identification of the frequent fliers. PLoS One, 12(1): e0170567.
Keithlin, J., J. Sargeant, M.K. Thomas, and A. Fazil. 2014.
Systematic review and meta-analysis of the proportion of
Campylobacter cases that develop chronic sequelae. BMC Public Health
14: 1-19.
National Drinking Water Advisory Committee (NDWAC). 2000.
Recommended Guidance for Review of Existing National Primary
Drinking Water Regulations. November 2000.
National Research Council (NRC). 2006. Fluoride in drinking-water: A
Scientific Review of EPA's Standards. The National Academies Press,
Washington, DC.
National Toxicology Program (NTP). 2023. NTP Board of Scientific
Counselors Working Group Report on the Draft State of the Science
Monograph and the Draft Meta-Analysis Manuscript on Fluoride.
Research Triangle Park, NC: U.S. Department of Health and Human
Services, National Institutes of Health, National Institute of
Environmental Health Sciences, NTP.
Schaeffer, F., K. Tower, and A.S. Weissfeld. 2012. What's Up with
Aircraft Drinking Water? Clinical Microbiology Newsletter, 34(2): 9-
13.
Stokdyk J.P., A.D. Firnstahl, J.F. Walsh, S.K. Spencer, J.R. de
Lambert, A.C. Anderson,
[[Page 59644]]
L.W. Rezania, B.A. Kieke Jr. and M.A. Borchardt. 2020. Viral,
bacterial, and protozoan pathogens and fecal markers in wells
supplying groundwater to public water systems in Minnesota, USA.
Water Research. 178: 115814.
Szabo, J.; M. Rodgers; J. Mistry; J. Steenbock; and J. Hall. 2019.
The effectiveness of disinfection and flushing procedures to prevent
coliform persistence in aircraft water systems. Water Supply. 19
(5): 1339-1346. https://doi.org/10.2166/ws.2018.195.
U.S. Department of Health and Human Services Federal Panel on
Community Water Fluoridation. 2015. U.S. Public Health Service
Recommendation for Fluoride Concentration in Drinking Water for the
Prevention of Dental Caries. Public Health Reports. 2015 Jul-Aug;
130(4):318-31. doi: 10.1177/003335491513000408.
USEPA. 1985. National Primary Drinking Water Regulations; Volatile
Synthetic Organic Chemicals; Final Rule and Proposed Rule. 50 FR
46880. November 13, 1985.
USEPA. 1986. National Primary and Secondary Drinking Water
Regulations; Fluoride; Final Rule. 51 FR 11396. April 2, 1986.
USEPA. 1987. National Primary Drinking Water Regulations; Synthetic
Organic Chemicals; Monitoring for Unregulated Contaminants; Final
Rule. 52 FR 25690. July 8, 1987.
USEPA 1989. Drinking Water; National Primary Drinking Water
Regulations; Total Coliforms (including Fecal Coliforms and E.
coli); Final Rule. 54 FR 27544. June 29, 1989.
USEPA. 1991. National Primary Drinking Water Regulations-Synthetic
Organic Chemicals and Inorganic Chemicals; Monitoring for
Unregulated Contaminants; National Primary Drinking Water
Regulations Implementation; National Secondary Drinking Water
Regulations; Final Rule. 56 FR 3526. January 30, 1991.
USEPA. 1992. Drinking Water; National Primary Drinking Water
Regulations-Synthetic Organic Chemicals and Inorganic Chemicals;
National Primary Drinking Water Regulations Implementation. 57 FR
31776. July 17, 1992.
USEPA. 1998. Toxicological Review of Beryllium and Compounds. EPA/
635/R-98/008. Washington, DC: U.S. Environmental Protection Agency
(USEPA). https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/999207.
USEPA. 2001. Integrated Risk Information System (IRIS) Chemical
Assessment Summary: Hexachlorocyclopentadiene. Washington, DC: U.S.
Environmental Protection Agency (USEPA), Office of Research and
Development, National Center for Environmental Assessment. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10509468.
USEPA. 2001a. National Primary Drinking Water Regulations: Filter
Backwash Recycling Rule. 66 FR 31086. June 8, 2001.
USEPA. 2002. IRIS Toxicological Review of 1,1-Dichloroethylene in
Support of Summary Information. EPA/635/R02/002. Washington, DC:
U.S. Environmental Protection Agency (USEPA), National Center for
Environmental Assessment, Office of Research and Development.
https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10721895.
USEPA. 2003. National Primary Drinking Water Regulations;
Announcement of Completion of EPA's Review of Existing Drinking
Water Standards. Notice. 68 FR 42908. July 18, 2003.
USEPA. 2004. Reregistration Eligibility Decision (RED) for Lindane.
Washington, DC: U.S. Environmental Protection Agency (USEPA), Office
of Prevention, Pesticides and Toxic Substances. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10492448.
USEPA. 2005. Toxicological Review of Barium and Compounds (CAS No.
7440-39-3) in Support of Summary Information on the Integrated Risk
Information System (IRIS) (Revised). EPA/635/R-05/001. Washington,
DC: U.S. Environmental Protection Agency (USEPA). https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/11311280.
USEPA. 2006a. National Primary Drinking Water Regulations: Long-Term
2 Enhanced Surface Water Treatment Rule; Final Rule. 71 FR 654.
January 5, 2006.
USEPA. 2006b. National Primary Drinking Water Regulations: Ground
Water Rule; Final Rule. 71 FR 65574. November 8, 2006.
USEPA. 2007a. Acetochlor/Alachlor: Revised Cumulative Risk
Assessment for the Chloroacetanilides to Support the Proposed New
Uses on Alachlor and Acetochlor. Washington, DC: U.S. Environmental
Protection Agency (USEPA), Office of Prevention, Pesticides, and
Toxic Substances. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10492629.
USEPA. 2007b. Toxicological Review of 1,1,1-Trichloroethane. EPA/
635/R-03/013. Washington, DC: U.S. Environmental Protection Agency
(USEPA). https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/3004991.
USEPA. 2008. Carbofuran. HED Revised Risk Assessment for the Notice
of Intent to Cancel (NOIC). EPA-HQ-OPP-2007-1088-0034. Washington,
DC: U.S. Environmental Protection Agency (USEPA), Office of
Prevention, Pesticides, and Toxic Substances. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10494332.
USEPA. 2009a. Provisional Peer-Reviewed Toxicity Values for 1,2,4-
Trichlorobenzene, CASRN 120-82-1. EPA/690/R-09/065F. Cincinnati, OH:
U.S. Environmental Protection Agency (USEPA), Office of Research and
Development, National Center for Environmental Assessment, Superfund
Health Risk Technical Support Center. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10255709.
USEPA. 2009b. National Primary Drinking Water Regulations: Drinking
Water Regulations for Aircraft Public Water Systems. 74 FR 53590.
October 19, 2009.
USEPA. 2010a. National Primary Drinking Water Regulations;
Announcement of the Results of EPA's Review of Existing Drinking
Water Standards and Request for Public Comment and/or Information on
Related Issues. 75 FR 15500. March 29, 2010.
USEPA. 2010b. Toxicological Review of Hydrogen Cyanide and Cyanide
Salts. EPA/635/R-08/016F. Washington, DC: U.S. Environmental
Protection Agency (USEPA). https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/723657.
U.S. EPA. 2010c. Integrated Risk Information System (IRIS) Chemical
Assessment Summary: cis-1,2-Dichloroethylene, CASRN 156-59-2.
Washington, DC: U.S. Environmental Protection Agency (USEPA), Office
of Research and Development. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10493648.
USEPA. 2010d. Fluoride: Dose-Response Analysis for Non-Cancer
Effects. EPA/820/R-10/019. Washington, DC: U.S. Environmental
Protection Agency (USEPA), Office of Water. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10493692.
USEPA. 2010e. Long Term 2 Enhanced Surface Water Treatment Rule:
Toolbox Guidance Manual. EPA 815-R-09-016. April 2010. https://www.epa.gov/dwreginfo/long-term-2-enhanced-surface-water-treatment-rule-documents.
USEPA. 2011. Trichloroethylene; CASRN 79-01-6. Integrated Risk
Information System (IRIS) Chemical Assessment Summary. Last Revised
September 28, 2011. Retrieved from https://iris.epa.gov/ChemicalLanding/&substance_nmbr=199.
USEPA. 2012. Tetrachloroethylene (Perchloroethylene); CASRN 127-18-
4. Integrated Risk Information System (IRIS) Chemical Assessment
Summary. Last Revised February 10, 2012. Retrieved from https://iris.epa.gov/ChemicalLanding/&substance_nmbr=106.
USEPA. 2013. National Primary Drinking Water Regulations: Revisions
to the Total Coliform Rule; Final Rule. 78 FR 10269. February 13,
2013.
USEPA. 2015a. Peer Review Handbook 4th Edition. October 2015.
Available online at: https://www.epa.gov/sites/default/files/2015-10/documents/epa_peer_review_handbook_4th_edition_october_2015.pdf.
USEPA. 2015b. Endothall: Human Health Risk Assessment in Support of
Registration Review, and the Petition to Re-Evaluate Tolerances for
Livestock, and Remove the Restriction that Prohibits Livestock from
Drinking Treated Water. EPA-HQ-OPP-2015-0591-0012. Washington, DC:
U.S. Environmental Protection Agency (USEPA), Office of Chemical
Safety and Pollution Prevention, Health Effects
[[Page 59645]]
Division. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10494329.
USEPA. 2016. Six-Year Review 3--Health Effects Assessment for
Existing Chemical and Radionuclide National Primary Drinking Water
Regulations--Summary Report. EPA 822-R-16-008.
USEPA. 2017a. National Primary Drinking Water Regulations;
Announcement of the Results of EPA's Review of Existing Drinking
Water Standards and Request for Public Comment and/or Information on
Related Issues. 82 FR 3518. January 11, 2017.
USEPA. 2017b. Oxamyl Draft Human Health Risk Assessment in Support
of Registration Review. Washington, DC: U.S. Environmental
Protection Agency (USEPA), Office of Chemical Safety and Pollution
Prevention, Health Effects Division. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10532947.
USEPA. 2017c. 2,4-D Revised Human Health Risk Assessment for
Registration Review. Washington, DC: U.S. Environmental Protection
Agency (USEPA), Office of Chemical Safety and Pollution Prevention,
Health Effects Division. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10532862.
USEPA. 2017d. Glyphosate: Draft Human Health Risk Assessment in
Support of Registration Review. EPA-HQ-OPP-2009-0361-0068.
Washington, DC: U.S. Environmental Protection Agency (USEPA), Office
of Chemical Safety and Pollution Prevention. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10532909.
USEPA. 2018a. Draft Atrazine Human Health Risk Assessment for
Registration Review. EPA-HQ-OPP-2013-0266-1256. Washington, DC: U.S.
Environmental Protection Agency (USEPA). https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10533087.
USEPA. 2018b. Simazine: Human Health Risk Assessment for
Registration Review and to Support the Registration of Proposed Uses
on Citrus Fruit (Crop Group 10-10), Pome Fruit (Crop Group 11-10),
Stone Fruit (Crop Group 12-12), Tree Nuts (Crop Group 14-12), and
Tolerance Amendment for Almond Hulls. Washington, DC: U.S.
Environmental Protection Agency (USEPA), Office of Chemical Safety
and Pollution Prevention. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10533123.
USEPA. 2019. Information Collection Request Submitted to OMB for
Review and Approval; Comment Request; Contaminant Occurrence Data in
Support of the EPA's Fourth Six-Year Review of National Primary
Drinking Water Regulations. 84 FR 58381. October 31, 2019.
USEPA. 2020a. Microbial Disinfection Byproducts Rules: Public
Meeting to Inform Potential Rule Revisions. Notice. 85 FR 61680.
September 30, 2020.
USEPA. 2020b. Diquat. Human Health Risk Assessment for the
Establishment Of A Tolerance Without U.S. Registration For Residues
in/on Crop Subgroup 6C Dried Shelled Pea and Bean (Except Soybean).
EPA-HQ-OPP-2017-0291-0009. Washington, DC: U.S. Environmental
Protection Agency (USEPA), Office of Chemical Safety and Pollution
Prevention. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10533339.
USEPA. 2020c. Picloram Draft Human Health Risk Assessment in Support
of Registration Review. Washington, DC: U.S. Environmental
Protection Agency (USEPA), Office of Chemical Safety and Pollution
Prevention, Health Effects Division. https://hero.epa.gov/hero/index.cfm/reference/details/reference_id/10533340.
USEPA. 2020d. ``The Standardized Monitoring Framework: A Quick
Reference Guide.'' EPA 816-F-20-002. May 2020. https://www.epa.gov/dwreginfo/standardized-monitoring-framework-quick-reference-guide.
USEPA. 2020e. Use of Total Nitrate and Nitrite Analysis for
Compliance Determinations with the Nitrate Maximum Contaminant Level
(WSG 213). November 30, 2020. https://www.epa.gov/sites/default/files/2021-01/documents/wsg_213_nitrate_wsg_11-30-2020_signed_508-compliantfinal.pdf.
USEPA. 2020f. Clarification of Free and Total Cyanide Analysis for
Safe Drinking Water Act (SDWA) Compliance Revision 1.0. EPA 815-B-
20-004. June 2020.
USEPA. 2022a. Request for Nominations for the Science Advisory Board
Radionuclide Cancer Risk Coefficients Review Panel. 87 FR 15988.
March 21, 2022.
USEPA. 2022b. Availability of the Draft IRIS Toxicological Review of
Hexavalent Chromium. 87 FR 63774. October 10, 2022.
USEPA. 2023a. National Primary Drinking Water Regulations for Lead
and Copper: Improvements (LCRI). 88 FR 84878. December 6, 2023.
USEPA. 2023b. Availability of the Protocol for the Nitrate and
Nitrite IRIS Assessment (Oral). 88 FR 77310. November 9, 2023.
USEPA. 2024a. PFAS National Primary Drinking Water Regulation. 89 FR
32532. April 26, 2024.
USEPA. 2024b. National Primary Drinking Water Regulations: Consumer
Confidence Report Rule Revisions. 89 FR 45980. May 24, 2024.
USEPA. 2024c. EPA Protocol for the Fourth Review of Existing
National Primary Drinking Water Regulations. EPA 815-R-24-018.
USEPA. 2024d. Data Management and Quality Assurance/Quality Control
Process for the Fourth Six-Year Review Information Collection
Request Dataset. EPA 815-R-24-017.
USEPA. 2024e. Chemical Contaminant Summaries for the Fourth Six-Year
Review of Existing National Primary Drinking Water Regulations. EPA
815-S-24-002.
USEPA. 2024f. Results of the Health Effects Assessment for the
Fourth Six-Year Review of Existing Chemical and Radionuclide
National Primary Drinking Water Standards. EPA 815-R-24-020.
USEPA. 2024g. Analytical Feasibility Support Document for the Fourth
Six-Year Review of National Primary Drinking Water Regulations. EPA
815-R-24-015.
USEPA. 2024h. Analysis of Regulated Contaminant Occurrence Data from
Public Water Systems in Support of the Fourth Six-Year Review of
National Primary Drinking Water Regulations: Chemical Phase and
Radionuclides Rules. EPA 815-R-24-014.
USEPA. 2024i. Review of Fluoride Occurrence for the Fourth Six-Year
Review. EPA 815-R-24-021.
USEPA. 2024j. Occurrence Analysis for Potential Source Waters for
the Fourth Six-Year Review of National Primary Drinking Water
Regulations. EPA 815-R-24-019.
USEPA. 2024k. Support Document for the Fourth Six-Year Review of
Drinking Water Regulations for Acrylamide and Epichlorohydrin. EPA
815-R-24-023.
USEPA. 2024l. Consideration of Other Regulatory Revisions in Support
of the Fourth Six-Year Review of the National Primary Drinking Water
Regulations: Chemical Phase Rules and Radionuclides Rule. EPA 815-R-
24-016.
USEPA. 2024m. Six-Year Review 4 Technical Support Document for
Microbial Contaminant Regulations. EPA 815-R-24-022.
Wallender, E.K., E.C. Ailes, J.S. Yoder, V.A. Roberts, and J.M.
Brunkard. 2014. Contributing factors to disease outbreaks associated
with untreated groundwater. Ground Water. 52(6): 886-97.
World Health Organization (WHO). 2004. Guidelines for Drinking-Water
Quality, Third Edition. Volume 1: Recommendations. https://www.who.int/publications/i/item/9789241547611.
WHO. 2009. Guide to hygiene and sanitation in aviation, 3rd edition.
https://www.who.int/publications/i/item/9789241547772.
Michael S. Regan,
Administrator.
[FR Doc. 2024-15807 Filed 7-22-24; 8:45 am]
BILLING CODE 6560-50-P