Revisions to the Unregulated Contaminant Monitoring Regulation (UCMR 3) for Public Water Systems, 11713-11737 [2011-4641]
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Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Proposed Rules
payment only if means are authorized
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§ 26.23
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 141 and 142
Certification process.
[Docket No. OW–2009–0090; FRL–9274–2]
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(a) An appropriate State official may
request in writing that the Attorney
General determine whether the State
meets the requirements for certification
under § 26.22.
(b) Upon receipt of a State’s request
for certification, the Attorney General
will make the request publicly available
on the Internet (including any
supporting materials included in the
request) and publish a notice in the
Federal Register—
(1) Indicating that the State has
requested certification;
(2) Identifying the Internet address at
which the public may view the State’s
request for certification; and
(3) Soliciting public comment on the
request.
(c) The State’s request will be
reviewed by the Attorney General. The
review will include consideration of
timely public comments received in
response to the Federal Register notice
under paragraph (b) of this section. The
certification will be published in the
Federal Register if certification is
granted. The certification will include a
determination of the date the capital
counsel mechanism qualifying the State
for certification was established.
(d) A certification by the Attorney
General reflects the Attorney General’s
determination that the State capital
counsel mechanism reviewed under
paragraph (c) of this section satisfies 28
U.S.C. chapter 154’s requirements. A
State may request a new certification by
the Attorney General to ensure the
continued applicability of chapter 154
in cases in which State postconviction
proceedings occur after a change or
alleged change in the State’s certified
capital counsel mechanism. Changes in
a State’s capital counsel mechanism do
not affect the applicability of chapter
154 in any case in which a mechanism
certified by the Attorney General existed
throughout State postconviction
proceedings in the case.
Dated: February 25, 2011.
Eric H. Holder, Jr.,
Attorney General.
[FR Doc. 2011–4800 Filed 3–2–11; 8:45 am]
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Revisions to the Unregulated
Contaminant Monitoring Regulation
(UCMR 3) for Public Water Systems
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
The 1996 amendments to the
Safe Drinking Water Act (SDWA)
require that the United States
Environmental Protection Agency (EPA
or the Agency) establish criteria for a
program to monitor unregulated
contaminants and to publish a list of
contaminants to be monitored every five
years. This action meets the SDWA
requirement by proposing the design for
the third UCMR cycle (i.e., UCMR 3).
EPA is proposing six EPA-developed
analytical methods, and four equivalent
consensus organization-developed
methods to monitor for 28 new UCMR
chemical contaminants. In addition,
EPA proposes monitoring for two
viruses, for a total of 30 UCMR 3
contaminants. As envisioned, virus
analysis (along with related analysis for
pathogen indicators) would be
conducted in laboratories under EPA
contract. UCMR 3 provides EPA and
other interested parties with
scientifically valid data on the
occurrence of these contaminants in
drinking water, permitting the
assessment of the number of people
potentially being exposed and the levels
of that exposure. These data are the
primary source of occurrence and
exposure information the Agency uses
to determine whether to regulate these
contaminants. In addition, as part of an
Expedited Methods Update, this
proposed action also would amend
regulations concerning inorganic
chemical sampling and analytical
requirements. A minor editorial
correction to the table moves methods
from the ‘‘Other’’ column to the ‘‘ASTM’’
column, as it applies to the inorganic
chemical sampling and analytical
requirements. The UCMR program is not
affected by these changes.
DATES: Comments must be received on
or before May 2, 2011.
ADDRESSES: Submit your comments,
identified by Docket ID No. OW–2009–
0090, by one of the following methods:
• https://www.regulations.gov. Follow
the on-line instructions for submitting
comments.
SUMMARY:
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• E-mail: OW–Docket@epa.gov.
• Mail: Send three copies of your
comments and any enclosures to: Water
Docket, United States Environmental
Protection Agency, Mail Code 282211T,
1200 Pennsylvania Avenue, NW.,
Washington, DC 20460, Attention
Docket ID No. OW–2009–0090.
Commenters should use a separate
paragraph for each issue discussed. In
addition, please mail a copy of your
comments on the information collection
provisions to the Office of Information
and Regulatory Affairs, Office of
Management and Budget (OMB), Attn:
Desk Officer for EPA, 725 17th St., NW.,
Washington, DC 20503.
• Hand Delivery: Deliver your
comments to Water Docket, EPA Docket
Center, Environmental Protection
Agency, Room 3334, 1301 Constitution
Ave., NW., Washington, DC, Attention
Docket ID No. OW–2009–0090. Such
deliveries are only accepted during the
Docket’s normal hours of operation, and
special arrangements should be made
for deliveries of boxed information.
Instructions: Direct your comments to
Docket ID No. EPA–OW–2009–0090.
EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or e-mail. The
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through https://
www.regulations.gov your e-mail
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses.
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Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available either
electronically in https://
www.regulations.gov or in hard copy at
the Water Docket, EPA/DC, EPA West,
Room 3334, 1301 Constitution Avenue,
NW., Washington, DC. This Public
Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number for the Public Reading Room is
(202) 566–1744, and the Water Docket is
(202) 566–2426.
FOR FURTHER INFORMATION CONTACT:
David J. Munch, Technical Support
Center, Office of Ground Water and
Drinking Water, United States
Environmental Protection Agency,
Office of Water, 26 West Martin Luther
King Drive (MS 140), Cincinnati, OH
45268; telephone (513) 569–7843; or email at munch.dave@epa.gov; or Brenda
D. Parris, Technical Support Center,
Office of Ground Water and Drinking
Water, United States Environmental
Protection Agency, Office of Water, 26
West Martin Luther King Drive (MS
140), Cincinnati, Ohio 45268; telephone
(513) 569–7961; or e-mail at
parris.brenda@epa.gov. For general
information, contact the Safe Drinking
Water Hotline. Callers within the United
States may reach the Hotline at (800)
426–4791. The Hotline is open Monday
through Friday, excluding legal
holidays, from 10 a.m. to 4 p.m., Eastern
time. The Safe Drinking Water Hotline
may also be found on the Internet at:
https://water.epa.gov/aboutow/ogwdw/
hotline/.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
Entities regulated by this action are
public water systems (PWSs). All large
community and non-transient noncommunity water systems serving more
than 10,000 people would be required to
monitor. A community water system
(CWS) means a PWS which has at least
15 service connections used by yearround residents or regularly serves an
average of at least 25 year-round
residents. A non-transient noncommunity water system (NTNCWS)
means a PWS that is not a CWS and that
regularly serves at least 25 of the same
people over six months per year. Only
a nationally representative sample of
community and non-transient noncommunity systems serving 10,000 or
fewer people would be required to
Category
State, Local, & Tribal
Governments.
Industry ..........................
Municipalities ..................
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a NAICS
monitor for chemical analytes (see
USEPA, 2001 for a description of the
statistical approach for the nationally
representative sample). Transient noncommunity systems (i.e., systems that
do not regularly serve at least 25 of the
same people over six months per year)
would not be required to monitor for the
chemical analytes. However, transient
ground water systems serving 1,000 or
fewer would be subject to possible
selection for virus monitoring. If
selected, these systems would be
required to permit EPA to sample and
analyze for List 3 contaminants and
pathogen indicators. EPA would pay for
all sampling and analysis costs
associated with virus monitoring at
these small systems. States, Territories,
and Tribes with primary enforcement
responsibility (primacy) to administer
the regulatory program for PWSs under
the Safe Drinking Water Act (SDWA)
may participate in the implementation
of UCMR 3 through Partnership
Agreements (PAs) (see discussion of
PAs in section III.G. of today’s action:
‘‘What Is the States’ Role in the UCMR
Program?’’). These primacy agencies
may choose to conduct analyses to
measure for contaminants in water
samples collected for the UCMR 3;
however, the PWS remains responsible
for compliance. Regulated categories
and entities are identified in the
following table.
NAICS a
Examples of potentially regulated entities
States, local and Tribal governments that analyze water samples on behalf of public water systems
required to conduct such analysis; States, local and Tribal governments that directly operate community, transient and non-transient non-community water systems required to monitor.
Private operators of community and non-transient non-community water systems required to monitor.
Municipal operators of community and non-transient non-community water systems required to monitor.
924110
221310
924110
= North American Industry Classification System.
This table is not exhaustive, but rather
provides a guide for readers regarding
entities likely to be regulated by this
action. This table lists the types of
entities that EPA is now aware may
potentially be regulated by this action.
Other types of entities not listed in the
table could also be regulated. To
determine whether your facility is
regulated by this action, you should
carefully examine the definition of PWS
in § 141.2 of Title 40 of the Code of
Federal Regulations, and applicability
criteria in § 141.40(a)(1) and (2) of
today’s proposed action. If you have
questions regarding the applicability of
this action to a particular entity, consult
the persons listed in the preceding FOR
FURTHER INFORMATION CONTACT section.
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B. Copies of This Document and Other
Related Information
This document is available for
download at: https://
www.regulations.gov. For other related
information, see preceding discussion
on docket.
Abbreviations and Acronyms
μg/L Microgram per liter
ASDWA Association of State Drinking
Water Administrators
ASTM American Society for Testing
Materials
CBI Confidential Business Information
CCL Contaminant Candidate List
CFR Code of Federal Regulations
CWS Community water system
DSMRT Distribution system maximum
residence time
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EPA United States Environmental
Protection Agency
EPTDS Entry point to the distribution
system
FR Federal Register
GC/MS Gas Chromatography/Mass
Spectrometry
GWUDI Ground water under the direct
influence of surface water
HCFC–22 Chlorodifluoromethane
IC/MS Ion Chromatography/Mass
Spectrometry
ICR Information collection request
IHS Indian Health Service
LCMRL Lowest concentration minimum
reporting level
LC/MS/MS Liquid Chromatography/
Tandem Mass Spectrometry
LFSM Laboratory fortified sample matrix
LFSMD Laboratory fortified sample matrix
duplicate
MRL Minimum reporting level
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NAICS North American Industry
Classification System
NCOD National Drinking Water
Contaminant Occurrence Database
NPDWR National primary drinking water
regulation
NTNCWS Non-transient non-community
water system
NTTAA National Technology Transfer and
Advancement Act
OMB Office of Management and Budget
PA Partnership Agreement
PFBS Perfluorobutanesulfonic acid
PFHpA Perfluoroheptanoic acid
PFHxS Perfluorohexane sulfonic acid
PFNA Perfluorononanoic acid
PFOA Perfluorooctanoic acid
PFOS Perfluorooctane sulfonic acid
PT Proficiency testing
PWS Public water system
qPCR Quantitative polymerase chain
reaction
RFA Regulatory Flexibility Act
SM Standard Methods
SRF State Revolving Fund
SBA Small Business Administration
SDWA Safe Drinking Water Act
SDWIS/Fed Federal Safe Drinking Water
Information System
UCMR Unregulated Contaminant
Monitoring Regulation
UMRA Unfunded Mandates Reform Act of
1995
USEPA United States Environmental
Protection Agency
VOC Volatile Organic Compound
Table of Contents
I. General Information
A. Does this action apply to me?
B. Copies of This Document and Other
Related Information
II. Statutory Authority and Background
A. What is the statutory authority for this
action?
B. How does EPA meet these statutory
requirements?
C. How are the contaminant candidate list,
the National Contaminant Occurrence
Database, and the UCMR interrelated?
III. Requirements of the Unregulated
Contaminant Monitoring Program
A. What are the changes being proposed for
UCMR 3?
B. What priority contaminants were
selected for UCMR 3?
1. Twenty Eight Chemicals
2. Two Viruses
C. How Were minimum reporting levels
determined?
D. How would laboratories conduct UCMR
analyses?
E. What are the new applicability
considerations?
1. Applicability Based on Population
Served
2. Applicability for Transient Systems
F. UCMR 3 Timeline and Sampling Design
Considerations
1. UCMR 3 Reporting Considerations
2. Assessment Monitoring
3. Pre-Screen Testing
G. What is the states’ role in the UCMR
program?
IV. Cost of This Proposed Action
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory
Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation
and Coordination with Indian Tribal
Governments
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
H. Executive Order 13211: Actions that
Significantly Affect Energy Supply,
Distribution, or Use
I. National Technology Transfer and
Advancement Act
J. Executive Order 12898: Federal Actions
to Address Environmental Justice in
Minority Populations and Low-Income
Populations
VI. Public Involvement in Regulation
Development
VII. References
II. Statutory Authority and Background
A. What is the statutory authority for
this action?
Section 1445(a)(2) of the Safe
Drinking Water Act (SDWA), as
amended in 1996, requires that once
every five years, beginning in August
1999, the United States Environmental
Protection Agency (EPA) issue a new
list of no more than 30 unregulated
contaminants to be monitored by public
water systems (PWSs). It also requires
that EPA enter the monitoring data into
the Agency’s National Drinking Water
Contaminant Occurrence Database
(NCOD). EPA’s Unregulated
Contaminant Monitoring Regulation
(UCMR) program must ensure that only
a national representative sample of
PWSs serving 10,000 or fewer people
would be required to monitor. EPA must
vary the frequency and schedule for
monitoring based on the number of
persons served, the source of supply,
and the contaminants likely to be found.
B. How does EPA meet these statutory
requirements?
Today’s notice proposes 30
contaminants for monitoring during the
third five-year cycle, referred to as
‘‘UCMR 3.’’ These contaminants include:
28 chemicals using six analytical
methods and/or four equivalent
consensus organization-developed
methods, and two viruses using one
analytical method. EPA has developed a
proposed contaminant list (Exhibit 1)
and sampling design for UCMR 3 (2012–
2016) with input from both stakeholders
and an EPA–State working group.
EXHIBIT 1—PROPOSED CONTAMINANT LISTS
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List 1, Assessment Monitoring
17-b-estradiol
17-a-ethynylestradiol (ethinyl estradiol)
estriol
equilin
estrone
testosterone
4-androstene-3,17-dione
1,2,3-trichloropropane
1,3-butadiene
chloromethane (methyl chloride)
1,1-dichloroethane
n-propylbenzene
bromomethane (methyl bromide)
sec-butylbenzene
chlorodifluoromethane (HCFC–22)
bromochloromethane (Halon 1011)
1,4-dioxane
vanadium
molybdenum
cobalt
strontium
chlorate
perfluorooctane sulfonic acid (PFOS)
perfluorooctanoic acid (PFOA)
perfluorononanoic acid (PFNA)
perfluorohexane sulfonic acid (PFHxS)
perfluoroheptanoic acid (PFHpA)
perfluorobutanesulfonic acid (PFBS)
List 3, Pre-Screen Testing
enteroviruses
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EPA published the first list for the
Unregulated Contaminant Monitoring
Regulation cycle (i.e., UCMR 1) in the
Federal Register on September 17, 1999
(64 FR 50556), and the second list (i.e.,
UCMR 2) on January 4, 2007 (72 FR
367). The monitoring lists that were
applicable under UCMR 1 and 2 are
available at: https://water.epa.gov/
lawsregs/rulesregs/sdwa/ucmr/.
In UCMR 1, EPA established a threetiered approach for monitoring
contaminants based on the availability
of analytical methods. Assessment
Monitoring for List 1 contaminants
typically relies on analytical methods
that are in common use in drinking
water laboratories. Screening Survey
monitoring for List 2 contaminants
relies on newly developed analytical
methods that are not commonly used in
drinking water laboratories. Laboratory
capacity to perform List 2 analyses is
expected to be limited. Finally, UCMR
1 established the option of Pre-Screen
Testing for List 3 contaminants to
address contaminants with analytical
methods that are in an early stage of
development. The expectation was that
it would be used at a limited number of
systems determined to be most
vulnerable to the targeted contaminants.
For UCMR 2, EPA built on this
established structure, and instituted
some changes to the rule design. These
changes were based upon lessons
learned during UCMR 1. All large PWSs,
serving more than 10,000 people, and a
nationally representative selection of
800 small PWSs serving 10,000 or fewer
people monitored for List 1
contaminants. This monitoring was
conducted during a continuous 12month period during the January 2008
to December 2010 sampling time frame
(quarterly for surface water systems, and
twice, at 6-month intervals, for ground
water systems). Systems subject to
UCMR 2 included community water
systems (CWSs) and non-transient noncommunity water systems (NTNCWSs),
except those systems that purchase all
of their finished water from another
PWS.
EPA designed the Assessment
Monitoring sampling frame to ensure
that sample results would yield a high
level of confidence and a low margin of
error. The design for a nationally
representative sample of small systems
called for the sample to be stratified by
water source type (ground or surface
water), service size category, and State
(where each State is allocated a
minimum of two systems in its State
Monitoring Plan). With monitoring data
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from all large PWSs (a census of all large
systems) and a statistically
representative sample of 800 small
PWSs (for a total of over 4,000 systems),
UCMR1 and UCMR 2 Assessment
Monitoring provided sample data
suitable to characterize exposure, as
would UCMR 3. Twenty eight chemicals
are being proposed for Assessment
Monitoring under UCMR 3.
For the UCMR 2 Screening Survey,
monitoring for List 2 contaminants was
conducted by approximately 400 PWSs
serving more than 100,000 people (i.e.,
a census of all systems in this largest
size category), with a randomly selected
sample of 320 PWSs serving between
10,001 and 100,000 people, and 480
small PWSs serving 10,000 or fewer
people (EPA included additional PWSs
in the Screening Survey design under
UCMR 2—as compared to UCMR 1—to
increase the statistical power of the
sample). During UCMR 2, Screening
Survey systems were required to
monitor during a continuous 12-month
period during the time frame of January
2008 to December 2010 (quarterly for
surface water systems, and twice, at 6month intervals, for ground water
systems). With approximately 1,200
systems participating in the Screening
Survey, sufficient data were generated
to provide an overall national estimate
of population exposure. No List 2
Screening Survey monitoring is being
proposed under UCMR 3.
As under UCMR 1, no Pre-Screen
Testing was conducted during the
UCMR 2. However, in UCMR 3, two
viruses are proposed for Pre-Screen
monitoring.
EPA is proposing that UCMR 3
include: Assessment Monitoring for 28
chemicals; no Screening Survey; and,
Pre-Screen Testing for two viruses.
Other proposed changes between UCMR
2 and UCMR 3 are summarized in
section III.A. ‘‘What Are the Changes
Being Proposed for UCMR 3?’’, and
discussed in further detail throughout
today’s proposed rule preamble.
C. How are the contaminant candidate
list, the National Contaminant
Occurrence Database, and the UCMR
interrelated?
The 1996 amendments to SDWA
instituted the Contaminant Candidate
List (CCL) and UCMR programs to
provide information EPA needs to
determine which drinking water
contaminants have the greatest potential
to present a meaningful opportunity to
reduce health risk through a national
primary drinking water regulation
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(NPDWR). The CCL is the primary
mechanism for the identification of
contaminants that may require
regulation while UCMR provides EPA
with the data necessary to determine if
a contaminant occurs at a frequency and
concentration that would be a public
health concern. The CCL and UCMR are
coordinated parts of EPA’s risk
management process, and they support
each other. The UCMR sampling
program is limited by statute to 30
contaminants at one time, and was
designed in consideration of the
technical difficulty and expense of
analyzing up to 30 contaminants, as
well as their potential to occur in
treated drinking water at levels of public
health concern. The data collected
through the UCMR program are being
stored in the NCOD to: facilitate
analysis and review of contaminant
occurrence; guide the conduct of the
CCL process; and support the
Administrator’s determination whether
to regulate a contaminant in the interest
of protecting public health, as required
under SDWA section 1412 (b)(1).
Results of the UCMR 1 and 2 monitoring
can be viewed by the public at EPA’s
UCMR Web site: https://water.epa.gov/
lawsregs/rulesregs/sdwa/ucmr/data.cfm.
III. Requirements of the Unregulated
Contaminant Monitoring Program
A. What are the changes being proposed
for UCMR 3?
EPA developed, and is proposing in
today’s action, a slightly revised design
for UCMR 3 based on experience with
UCMR 1 and UCMR 2. EPA reviewed
various aspects of the UCMR 1 and 2
programs and identified several critical
changes that would improve
implementation. EPA’s proposed
approach and rationale for changes are
described in the following sections. Key
aspects of the UCMR program that
would remain the same include direct
implementation of the rule by EPA, the
design of Assessment Monitoring, and
EPA funding for the small system
testing. In addition to requesting
comment on the proposed list of
contaminants, EPA also requests
comment on: Monitoring based on retail
population; revised data elements; and
other changes between UCMR 2 and
UCMR 3 that are outlined in Exhibit 2.
Updates to Web addresses, applicability
dates, corrections of minor
typographical errors, and other minor
clerical edits are reflected in rule
language, but do not appear in Exhibit
2.
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EXHIBIT 2—NOTABLE CHANGES BEING PROPOSED FOR UCMR 3
Rule section
Description of change
Number
Title/description
141.35(a) and 141.40(a) .........
Population-based applicability
and related applicability
date.
141.35(c)(3)(ii) .........................
Demonstrating representative
ground water sampling locations.
141.35(c)(6)(ii) and
141.40(a)(5)(vi).
Reporting schedule ................
141.35(c)(6) and 141.35(d)(2)
Reporting monitoring results ..
141.35(e) .................................
Data elements ........................
141.40(a)(1) .............................
Applicability to transient systems.
141.40(a)(2)(ii)(C) and
141.40(a)(3).
Pre-Screen Testing viruses
and indicators.
141.40(a)(3) .............................
Analytes to be monitored and
related specifications.
141.40(a)(4)(i)(B) .....................
Sampling requirements—frequency.
141.40(a)(4)(i)(C) ....................
Location .................................
141.40(a)(5)(iii) ........................
Minimum Reporting Level
(MRL) definition.
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B. What priority contaminants were
selected for UCMR 3?
EPA used a stepwise prioritization
process to identify potential UCMR 3
contaminants. As a first step, the
Agency reviewed the recently
promulgated CCL 3 list and the ‘‘preCCL’’ contaminants considered in the
development of CCL 3. Under the CCL
3 process, the Agency considered the
best available data and information on
health effects and occurrence to
evaluate 7,500 unregulated
contaminants. The final CCL 3 is
comprised of 104 chemicals or chemical
groups and 12 microbiological
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Base applicability on retail population. Under UCMR 1 and
2, systems that purchased all of their water were not required to monitor. These systems would now be subject
to UCMR monitoring requirements. The new SDWIS/Fed
applicability date (i.e., the date used to determine which
systems are subject to monitoring) is also specified
Clarifies that when identifying a representative well, the well
must be one of the higher annual volume producing and
consistently active wells. Should this location go off-line,
an alternative location must be sampled.
Reduces time for labs to electronically report results (from
120 to 60 days); and for systems to review, approve, and
report data (from 60 to 30 days).
Requires small and large systems to report all data elements in Table 1 with each sample. Previously, only a
subset of the data elements were to be reported with
each sample.
Revises Table 1 of § 141.35 to:
• Add the zip code, optional zip code extension, and
zip codes served to Data Element 4—Sampling Point
Identification Code.
• Clarify and update the definition of Data Element 6—
Disinfectant Type.
Removes exemption for transient systems, which would
now be subject to monitoring for List 3 contaminants if
notified by EPA or State.
Systems participating in List 3 monitoring would be required
to allow EPA to monitor for enterovirus and norovirus and
collect specified pathogen indicators.
Revises Table 1 of this section to include: ............................
New list of 28 priority contaminants, with 6 EPA-developed and 4 consensus organization developed analytical methods, as well as new monitoring dates of
January 2013 through December 2015.
Specifies that schedules must be adjusted based on sample
point availability. Clarifies that sampling points within a
system may have different schedules.
Also, revises Table 2 of this section to include monitoring
requirements for microbiological contaminants for ground
water systems at a frequency of two times during a consecutive 12-month period.
Requires systems conducting Assessment Monitoring to collect metal and chlorate samples at distribution system
maximum residence time (DSMRT) sampling locations. If
these locations are not defined, requires PWS to collect
samples at locations that best represents the maximum
residence time in the distribution system.
Revises the definition of the MRL ..........................................
contaminants that were selected through
a data-driven process that considered
adverse health effects (potency and
severity) and occurrence (prevalence
and magnitude). The list includes
pesticides, biological toxins,
disinfection byproducts, chemicals used
in commerce, and waterborne pathogens
(74 FR 51850, October 8, 2009 (USEPA,
2009c)). EPA used CCL 3, along with
additional sources of information about
other emerging contaminants of
potential concern, to establish an initial
list of approximately 150 potential
UCMR 3 contaminants.
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Corresponding
preamble
section
III.E.
III.F.
III.F.
III.F.
III.F. and V.J.
III.E.
III.B. and III.F.
III.B. and III.F.
III.F.
III.F.
III.C.
The proposed contaminant list for
UCMR 3 was further pared down as
follows: (1) Contaminants with no
currently available methods, or methods
that would not be ready in time for
UCMR 3 monitoring were eliminated;
and, (2) those contaminants included in
UCMR 1 or UCMR 2 monitoring were
also eliminated from inclusion. This
narrowed list of fewer than 35 analytes
was further considered by an EPA and
State working group, and prioritized
using health effects data and other
critical endpoints, to arrive at a final
proposed list of 30 analytes listed in
Exhibit 3. Further information on this
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prioritization process, and on the health
effects and occurrence data EPA used to
select the chemical analytes proposed
for UCMR 3 are contained in ‘‘Possible
Contaminants for Inclusion on UCMR
3—Information Compendium’’ (USEPA,
2010d).
EPA has not included hexavalent
chromium (chromium-6) in the
proposed list of chemicals for UCMR 3
monitoring; however, EPA is aware of
potential concerns about chromium-6
occurrence in public water supplies.
EPA thus requests comment on whether
the Agency should include chromium-6
as one of the 30 contaminants for UCMR
3 Assessment Monitoring. EPA has
recently issued voluntary guidance to
water systems on monitoring for
chromium-6, including
recommendations regarding the use of a
modified version of EPA Method 218.6
for the analysis of samples and a
recommended reporting level of 0.06
ug/L (see https://water.epa.gov/drink/
info/chromium/guidance.cfm). If EPA
were to include chromium-6 in UCMR
3, the Agency would incorporate it into
Assessment Monitoring. Under this
approach, EPA would make chromium6 monitoring mandatory for all large
water systems and a subset of small
systems; see also Section III.F.2 for
further discussion of the Assessment
Monitoring approach. EPA requests
comments on what contaminant(s)
should be removed from the list of 30
UCMR 3 contaminants if chromium-6
were added, as well as comments
regarding the recommended and
alternative analytical method(s) and the
appropriate reporting level. EPA also
requests comments on whether total
chromium should also be measured
concurrent with chromium-6. Side-byside measurements may provide
valuable information on relative
occurrence and the utility of total
chromium monitoring as a surrogate for
chromium-6.
EPA compiled background
information for each of the 28 chemicals
being proposed for monitoring,
including: Source and use; health
effects; production and release;
occurrence in water; and persistence
and mobility (USEPA, 2010d). Health
effects, occurrence in water,
transmission and treatment information
were considered for the two viruses.
The primary source of this information
is CCL 3 (74 FR 51850, October 8, 2009
(USEPA, 2009c)). Where newer or
additional information was available
and for those proposed UCMR 3
contaminants that were not part of CCL
3, references are provided separately. In
addition, preliminary occurrence data
are included that were collected as part
of EPA’s second Six-Year Review of
NPDWRs (75 FR 15500, March 29, 2010
(USEPA, 2010b)).
EXHIBIT 3—30 PROPOSED UCMR 3 ANALYTES
7 Hormones using EPA Method 539 (LC/MS/MS) 1:
17-b-estradiol
17-a-ethynylestradiol (ethinyl estradiol)
estriol (16-a-hydroxy-17-b-estradiol)
estrone
testosterone
4-androstene-3,17-dione
equilin
9 Volatile Organic Compounds (VOC) using EPA Method 524.3 (GC/MS) 2:
1,2,3-trichloropropane
1,3-butadiene
chloromethane (methyl chloride)
1,1-dichloroethane
n-propylbenzene
bromomethane (methyl bromide)
sec-butylbenzene
chlorodifluoromethane (HCFC–22)
bromochloromethane (halon 1011)
Synthetic Organic Compound using EPA Method 522 (GC/MS) 3:
1,4-dioxane
4 Metals using EPA Method 200.8 (IC/MS) 4 or alternate SM 5 or ASTM Methods 6:
cobalt
molybdenum
strontium
vanadium
Oxyhalide Anion using EPA Method 300.1 (IC/Conductivity) 7 or alternate SM 8 or ASTM Methods 9:
chlorate
6 Perfluorinated Chemicals using EPA Method 537 (LC/MS/MS) 10:
perfluorooctane sulfonate (PFOS)
perfluorooctanoic acid (PFOA)
perfluorononanoic acid (PFNA)
perfluorohexane sulfonic acid (PFHxS)
perfluoroheptanoic acid (PFHpA)
perfluorobutane sulfonic acid (PFBS)
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2 Viruses (see Section III.B.7 for methods discussion): 11
enterovirus
1.
2.
3.
4.
5.
6.
7.
8.
9.
norovirus
EPA Method 539 (LC/MS/MS) (USEPA, 2010c)
EPA Method 524.3 (GC/MS) (USEPA, 2009a)
EPA Method 522 (GC/MS) (USEPA, 2008)
EPA Method 200.8 (ICP/MS) (USEPA, 1994)
SM 3125 (SM, 1997)
ASTM D5673–10 (ASTM, 2010)
EPA Method 300.1 (IC/Conductivity) (USEPA, 1997)
SM 4110D (SM, 1997)
ASTM D6581–08 (ASTM, 2008)
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10. EPA Method 537 (LC/MS/MS) (USEPA, 2009b)
11. Monitoring also includes sampling for pathogen indicators such as total coliforms, E.coli, bacteriophage, Enterococci and aerobic spores.
EPA would pay for all sampling and analysis costs associated with virus monitoring at these small systems.
1. Twenty-Eight Chemicals
EPA proposes monitoring for 28
chemicals in UCMR 3. Details of the
health effects and occurrence data EPA
used to make these selections are
contained in ‘‘Possible Contaminants for
Inclusion on UCMR 3—Information
Compendium’’ (USEPA, 2010d),
available at Docket ID No. OW–2009–
0090.
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2. Two Viruses
a. Enterovirus and Norovirus
EPA proposes to monitor for
enterovirus and norovirus in UCMR 3.
Both enterovirus and norovirus (a group
of viruses in the Caliciviruses family)
are listed on CCL3. They are proposed
for UCMR 3 monitoring because very
limited data are available (Francy et al.,
2004) on their occurrence in
undisinfected PWSs located in sensitive
hydrogeological areas. Of particular
concern are PWSs in areas with karst or
fractured bedrock, as well as in noncommunity water systems. Recent data
indicate that undisinfected ground
water systems with low total coliform
occurrence (and no Total Coliform Rule
violations) had significant viral
presence and disease manifestation
(Borchardt, 2008). This draft study
showed a statistically significant
correlation between viral qPCR
(quantitative polymerase chain reaction)
and self-reported acute gastrointestinal
illness. This indicates that qPCR can be
used as an indicator of relative
vulnerability and potential disease
incidence. Borchardt’s work showed a
viral occurrence of 9% for enterovirus
and 4% for norovirus in CWSs, almost
all of which were in aquifers not
considered sensitive. EPA proposes to
perform this monitoring as a Pre-Screen
Testing of targeted undisinfected ground
water systems located in karst or
fractured bedrock. The monitoring
would include CWSs, as well as nontransient and transient non-community
water systems. Monitoring would also
include sampling for pathogen
indicators such as total coliforms, E.coli,
bacteriophage, Enterococci and aerobic
spores.
The objectives of this monitoring are
to obtain information concerning the
occurrence of enterovirus and norovirus
for further evaluation, and to gain a
better understanding of the cooccurrence of pathogen indicators and
viruses.
Enterovirus would be monitored
using one method that has two detection
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assays. The first is a tissue culture assay
also used in the Information Collection
Rule survey conducted by EPA (USEPA,
1996), with one change; the 1 MDS filter
would be replaced with the
NanoCeram® filter, to significantly
reduce sampling cost. The NanoCeram®
filter has proven to be as effective as 1
MDS filter for the recovery of
enteroviruses (Karim et al., 2009) and
norovirus (Gibbons et al., 2010). The
second assay is the qPCR, which detects
the viral nucleic acid.
Norovirus would only be monitored
using qPCR, as there is no tissue culture
method available. Both norovirus and
enterovirus qPCR would be performed
as per the protocol in Lambertini et al.
(2008). The qPCR primers and probe for
GI Norovirus would be as referenced in
Jothikumar et al. (2005), while GII
Norovirus primers and probe would be
as referenced in Ando et al. (1995).
Primers and probe referenced in De
Leon et al. (1990) and Monpoeho et al.
(2000) would be used for enterovirus
qPCR.
A technical presentation describing
Borchardt’s work, and supporting EPA’s
rationale for including these viruses in
UCMR 3, is available through the
docket. EPA welcomes comments on the
Borchardt data and on the merits of the
proposed UCMR 3 monitoring. EPA
anticipates that a peer-reviewed journal
article describing the Borchardt work
will be published in advance of the
publication of the UCMR 3 final rule,
and is committed to conducting
appropriate peer review of the UCMR 3
virus data before any final regulatory
determination by the Agency.
C. How were minimum reporting levels
determined?
The quality of measurement
definition is based on a standard tool of
analytical chemistry, percent recovery
of a known amount of analyte added to
a reagent water sample (spiked blank).
The lowest concentration minimum
reporting level (LCMRL) is defined as
the lowest spiking concentration at
which recovery of between 50 and
150% is expected 99% of the time by a
single analyst.
The LCMRL is estimated using
sophisticated statistical procedures that
have been incorporated into an LCMRL
calculator tool that is available on EPA’s
Web site (https://water.epa.gov/scitech/
drinkingwater/labcert/
analyticalmethods_ogwdw.cfm). The
statistical tool estimates a probability
distribution for spike recovery as a
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function of spiking concentration. This
requires regression modeling that
estimates expected value and expected
variance for repeated measurements as
functions of spiking concentration.
Often this variance is an increasing
function of spiking level. In this case,
ordinary least squares regression is not
appropriate to estimate the expected
value function. Weighted least squares
is used with weights proportional to the
reciprocal of the expected variance,
multiplied by a weight (Tukey’s
biweight) that gives robustness against
outliers. The variance model is
estimated using a Generalized Linear
Model. To estimate these regressions, an
experimental design with replicate
spiking at multiple concentrations is
required. If the LCMRL estimate is
below the lowest non-blank spiking
concentration or above the highest
spiking concentration, another set of
blanks must be spiked so that the
LCMRL is bracketed by the lowest and
highest spike concentrations when the
LCMRL is re-estimated. The spiked
concentrations must be contained
within the instrument calibration curve
that is routinely used for each analyte.
The combined procedure provides a
robust estimator of the LCMRL and a
sophisticated and useful measure of
method capability.
MRL
In today’s action, EPA is proposing
revisions to the definition of the
minimum reporting level (MRL). The
proposed definition of the MRL reflects
improvements in the statistical
procedures for determining the LCMRL
and MRL. These improvements were
implemented by EPA to make the
models more robust, i.e., so that the
models can accommodate a wider range
of observed LCMRL data sets. The MRL
for an analyte measured by a specified
analytical method is designed to be an
estimate of an LCMRL that is
achievable, with 95% confidence, by a
capable analyst/laboratory at least 75%
of the time. Such a demonstration of
ability to reliably make quality
measurements at the MRL is intended to
achieve high quality across the nation’s
laboratories.
In UCMR 2, the MRL was established
by EPA by adding the mean of the
LCMRL determined according to the
procedure detailed in ‘‘Statistical
Protocol for the Determination of The
Single-Laboratory Lowest Concentration
Minimum Reporting Level (LCMRL) and
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Validation of the Minimum Reporting
Level (MRL)’’ (USEPA, 2004), (https://
www.epa.gov/ogwdw/methods/pdfs/
methods/methods_lcmrl.pdf) by the
primary and secondary laboratories
conducting the development and
validation of the analytical method to
three times the difference of the
LCMRLs. If LCMRL data from three or
more laboratories were available, the
MRL was established by EPA by adding
three times the standard deviation of the
LCMRLs to the mean of the LCMRLs.
In UCMR 3, EPA estimated the MRL
for an analyte/method by obtaining data
from several laboratories performing
corresponding LCMRL studies. These
data are used to construct an
approximation to the distribution that
would result from picking at random a
laboratory/analyst proficient in
performing the analytical method, and
having them perform an LCMRL study
and compute an LCMRL estimate. The
strategy for computing the MRL is twofold. First, for each LCMRL data set, a
distribution for repeated LCMRL
determinations by the same laboratory/
analyst is estimated by generating a
large number of simulated values using
a Bayesian bootstrap approach. Second,
these values are combined to create an
estimated overall distribution. If a result
from one of the laboratories is
significantly higher than that of other
laboratories, this value would be downweighted using a robust weight
function. The resulting weighted values
are used to construct a probability
distribution from which the MRL is
computed as the 95th percentile. EPA
requests comments regarding the
proposed definition of the MRL.
D. How would laboratories conduct
UCMR analyses?
As proposed, all laboratories
conducting analyses for UCMR 3 List 1
contaminants would need to receive
EPA approval to perform those analyses.
Laboratories seeking approval would be
required to provide EPA with data that
demonstrate their successful completion
of an initial demonstration of capability
as outlined in each method, verification
of successful performance at the MRLs
as specified in today’s action, and
successful participation in an EPA
Proficiency testing (PT) program for the
analytes of interest. On-site audits of
selected candidate laboratories may be
conducted. Details of the EPA laboratory
approval program are contained in the
technical manual titled: ‘‘UCMR 3
Laboratory Approval Requirements and
Information Document’’ (USEPA,
2010e). This document will be available
on the electronic docket at: https://
www.regulations.gov and will be
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provided to laboratories that register for
the laboratory approval program. In
addition, EPA may supply analytical
reference standards of known
concentrations for selected analytes to
participating/approved laboratories,
where such standards are not readily
available through commercial sources.
Laboratory Approval Process for UCMR
3
The proposed UCMR 3 laboratory
approval program is the same as that
employed in previous UCMR cycles. It
is designed to assess and confirm the
capability of laboratories to perform
analyses using the methods listed in
§ 141.40(a)(3), Table 1, of today’s
proposed rule. The UCMR 3 laboratory
approval process is designed to assess
whether laboratories meet the required
equipment, laboratory performance, and
data reporting criteria described in
today’s action. This evaluation program
is voluntary in that it only applies to
laboratories intending to analyze UCMR
3 samples. However, EPA would require
systems to use UCMR 3 approved
laboratories when conducting
monitoring for those analytes listed in
Table 1 of § 141.40(a)(3) of this
proposed rule. A list of laboratories
approved for UCMR 3 would be posted
to EPA’s UCMR Web site: https://
water.epa.gov/lawsregs/rulesregs/sdwa/
ucmr/ucmr3/labs.cfm. Laboratories are
encouraged to apply for UCMR 3
approvals as early as possible, as
schedules for large PWS sampling
would be completed soon after the final
rule is promulgated. The steps for the
laboratory approval process are listed in
the following paragraphs, a through f.
a. Request to Participate.
To request participation in the UCMR
3 laboratory approval process, the
laboratory must contact EPA.
Laboratories must send this request to:
UCMR 3 Laboratory Approval
Coordinator, USEPA, Technical Support
Center, 26 West Martin Luther King
Drive (MS 140), Cincinnati, OH 45268;
or e-mail at:
UCMR_Sampling_Coordinator@epa.gov.
EPA plans to begin accepting requests
for registration forms for the List 1
(Assessment Monitoring) methods
beginning March 3, 2011. EPA
anticipates that the final opportunity for
a laboratory to request the necessary
registration forms would be 90 days
after final rule publication, though
laboratories are encouraged to apply as
early as is practical after the publication
of today’s proposed rule.
b. Registration.
Each laboratory that wishes to
participate in UCMR 3 monitoring
would be required to complete a
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registration form. EPA expects this
registration information to include:
Laboratory name; mailing address;
shipping address; contact name; phone
number; fax number; e-mail address;
and a list of the UCMR 3 methods for
which the laboratory is seeking
approval. The purpose of the
registration step is to provide EPA with
the necessary contact information, and
ensure that each laboratory receives a
customized application package of
materials and instructions for the
methods that it plans to use.
c. Application Package.
When EPA receives the registration
information, a customized application
package would be sent to the laboratory
for completion. Information requested
in the application would include the
following: Initial demonstration of
capability data, including precision,
accuracy, and results of MRL studies,
information regarding analytical
equipment, proof of current drinking
water laboratory certification, and
example chromatograms for each
method under review.
The laboratory would be required to
confirm that it will post UCMR 3
monitoring results (on behalf of its PWS
clients) to EPA’s UCMR electronic data
reporting system.
d. EPA Review of Application
Package.
EPA would review the application
package and, if necessary, request
follow-up information. Satisfactory
completion of this portion of the process
would be required for the laboratory to
participate in the UCMR 3 Proficiency
Testing (PT) program.
e. Proficiency Testing.
A PT sample is a synthetic sample
containing a concentration of an analyte
that is known to EPA, but unknown to
the laboratory being tested. To complete
the initial laboratory approval process, a
laboratory would be expected to meet
specific acceptance criteria for the
analysis of a UCMR 3 PT sample(s) for
each method for which the laboratory is
seeking approval. EPA intends to offer
up to four opportunities for a laboratory
to successfully analyze the UCMR 3 PT
samples. Up to three of these studies
would be conducted prior to the
publication of the final rule, but at least
one study would be conducted after
publication of the final rule. This would
allow laboratories to complete their
portion of the laboratory approval
process prior to publication of the final
rule, and therefore, receive their
approval, immediately following the
publication of the final rule, or to wait
until the final rule is published before
completing the required laboratory
approval analyses. A laboratory only
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needs to pass one of the PT studies for
each analytical method for which they
are requesting approval. Laboratories
applying for UCMR 3 approval, and
laboratories conducting UCMR 3
analyses, may be subject to on-site
laboratory audits. No PT studies would
be conducted after the start of
monitoring; however, laboratory audits
would be ongoing throughout the entire
monitoring period of 2013–2015. Initial
laboratory approval would be
contingent upon successful completion
of a PT study. Continued laboratory
approval is contingent upon successful
completion of audits.
f. Written EPA Approval.
After steps ‘‘a’’ through ‘‘e’’ of the PT
approval process have been successfully
completed, EPA would send the
laboratory a letter listing the methods
for which approval is pending (if the PT
study and laboratory evaluation is
conducted prior to promulgation of the
final rule) or approval is granted (after
promulgation of the final rule).
Laboratories receiving a pending
approval may then be approved without
further action, following promulgation
of the final rule, or they may need to
take additional action, contingent upon
what changes are applied to the rule
between this proposal and promulgation
of the final rule.
E. What are the new applicability
considerations?
In section 141.40(a) of today’s
proposed rule changes, EPA is
proposing a new applicability date for
information in the SDWIS/Fed system
inventory. As proposed, the
determination of whether a PWS is
required to monitor under UCMR 3
would be based on the type of system
(e.g., community water system, nontransient non-community water system,
etc.), and its retail population served, as
indicated by SDWIS/Fed on December
31, 2010.
In addition, EPA is proposing two
changes to the applicability of UCMR 3
to PWSs. First, EPA proposes that
applicability be based on retail
population served. Whereas under
UCMR 1 and 2 systems that purchased
all of their water were not required to
monitor; these systems would now be
subject to UCMR monitoring
requirements. Second, under UCMR 1
and 2, transient systems were exempt
from monitoring. EPA’s proposed
changes would include transient
systems in the universe from which EPA
may select small PWSs for List 3
monitoring. Such systems would only
be included in UCMR 3 List 3
monitoring if they are notified by EPA
that they have been selected, and this
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monitoring would be done by EPA or its
contractor. All other applicability
criteria for UCMR 3 remain the same as
those under UCMR 2.
1. Applicability Based on Population
Served
Under UCMR 1, large PWSs were
defined as those systems that served a
population of more than 10,000 people
and small PWSs were those that served
10,000 or fewer people. While this
included the sum of the population
served by the combined distribution
system, this requirement was
occasionally misunderstood. For UCMR
2, EPA clarified the population
definition to include the sum of the
retail population served directly by the
PWS plus the population served by any
consecutive system(s), receiving all or
part of its finished water from that PWS.
As established in the Stage 2
Disinfectants and Disinfection
Byproducts Rule (68 FR 49548, August
18, 2003 (USEPA, 2003)), EPA defines a
‘‘consecutive system’’ as a PWS that
buys or otherwise receives some or all
of its finished water from one or more
wholesale system(s). Under the
population definition of UCMR 2,
systems that purchased all of their water
from other systems were not required to
monitor. EPA is proposing a change in
the definition of system population to
include only a system’s retail
population. UCMR 3 requirements for
systems would be based on their retail
population served as reported to
SDWIS/Fed as ‘‘Population Served’’ (i.e.,
wholesale or consecutive populations
are not included).
EPA is proposing that PWSs be
required to monitor for UCMR 3
contaminants, regardless of whether
they purchase any or all of their water
from another system. The population
definitions used for the previous
UCMRs created an inconsistency for
PWSs purchasing their water. If a PWS
purchased all of their water, they were
not required to monitor at all, and
systems that had no retail connections
did have to monitor. If a PWS purchased
some of their water, they were required
to monitor from their own sources as
well as their purchased source. The new
proposed definition would eliminate
this inconsistency. It would also
eliminate the requirements for systems
with no retail connections to monitor.
EPA is aware that PWSs that purchase
water evaluate their supply needs and
associated costs, and may make
adjustments during the UCMR
monitoring period. They have been
known to change wholesale suppliers or
switch sources that they can directly
access and treat for their retail
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11721
customers. The dynamic nature of
wholesale water supply is prompting
EPA to propose and solicit stakeholder
comment on establishing retail
population as a clearer measure for
determining applicability of the UCMR
3 requirements. Retail population is a
consistent factor for applicability
determination and evaluating the direct
sources (all entry points including
wholesale connections) would improve
data quality by directly assessing the
drinking water served to the respective
retail population. It is also difficult to
accurately determine the total
population served by each source of
water. For example, if PWS ‘‘A’’ buys all
of its water from three different PWSs
(‘‘B, C, D’’), it is unclear how to divide
PWS A’s retail population among the
three PWSs to determine the wholesale
populations for systems B, C, and D.
Under the previous UCMR
specifications, the total population of all
systems was added together, which
could lead to overestimating the
population served by each source of
water.
Moreover, a system’s population is
used to determine exposure estimates.
Because the retail population comprises
all of the people exposed to water from
a particular system, EPA would have a
clearer understanding of the number of
people exposed to a detected
contaminant. The proposed change to
the definition of population would
allow EPA to better estimate the total
population served by a water system
and ensures that exposure calculations
are more accurate.
PWSs are required to report their
retail population to the Safe Drinking
Water Information System-Federal
(SDWIS/Fed), so this population is
readily accessible to EPA when
determining which systems are required
to monitor for the UCMR 3. Using a
system’s retail population would also
make the list of PWSs subject to UCMR
more stable over the UCMR 3
monitoring period, and eliminate
another inconsistency in previous
UCMRs. In past UCMRs, if a PWS began
purchasing all of their water after the
applicability date, the PWS would still
have to monitor under UCMR. If,
however, a system began using its own
water sources after the UCMR
applicability date, the system would not
be required to begin monitoring under
UCMR. Using a system’s retail
population to determine whether a
system is subject to UCMR requirements
would eliminate this disparity.
Note that systems that purchase water
with multiple connections from the
same wholesaler would be permitted to
propose one representative connection
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from that wholesaler. PWSs would
choose a sampling location from among
the higher annual volume EPTDS
connections. If the connection selected
as the representative EPTDS was not
available for sampling, an alternate
representative connection would need
to be sampled.
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2. Applicability for Transient Systems
Under UCMR 1 and 2, Section
141.40(a)(1), transient non-community
water systems were specifically
exempted from UCMR monitoring. EPA
is proposing revisions that would allow
for certain transient systems to be
selected for Pre-Screen Testing for List
3 contaminants. Under UCMR 3, EPA is
proposing to conduct Pre-Screen Testing
for enterovirus and norovirus and
related pathogen indicators at targeted
undisinfected ground water systems that
serve 1,000 or fewer customers. EPA is
To minimize the impact of the rule on
small systems (those serving 10,000 or
fewer people), EPA would pay for the
sample kit preparation, sample shipping
fees, and analysis costs for these
systems. In addition, no small system
would be required to monitor for both
List 1 and List 3 contaminants. Large
systems (those serving more than 10,000
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proposing to include transient systems
among the possible targeted systems—
and to focus on viruses and not
chemicals at those systems—since
viruses are acute pathogens and
exposure through a one-time ingestion
(e.g., at a transient system) is of
potential health concern. EPA requests
comments regarding the inclusion of
transient systems in UCMR 3 Pre-Screen
Testing.
As proposed under 141.40(a)(1) and
141.40(a)(2)(ii)(C), if any system
(including transient systems) is notified
by EPA or their state that they have been
selected for Pre-Screen Testing the
system must permit EPA (at EPA’s
expense) to sample and analyze for List
3 contaminants, and pathogen
indicators, such as total coliform, E.
coli, bacteriophage, Enterococci, and
aerobic spores.
F. UCMR 3 Sampling Design and
Reporting Considerations
people) would pay for the cost of
shipping and laboratory testing.
changes related to new UCMR 3
analytes.
Demonstrating Representative Ground
Water Sampling Locations: As
established under UCMR 2, large
systems that use ground water sources
and have multiple EPTDSs can, with
prior approval, conduct monitoring at
representative entry point(s) rather than
1. UCMR 3 Reporting Considerations
EPA is proposing a few notable
changes to reporting requirements based
on lessons learned from UCMR 1 and
UCMR 2, as well as some necessary
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As proposed, PWSs and EPA would
conduct sampling and analysis for List
1 and List 3 contaminants at each PWS
during a 12 month period within the
2013 to 2015 timeframe. Preparation
would begin prior to 2013 and would
include coordination of laboratory
approval, selection of representative
samples of small systems, development
of State Monitoring Plans, establishment
of monitoring schedules, and
notification of participating PWSs. As
proposed, UCMR 3 would not include a
Screening Survey for List 2
contaminants. Exhibit 4 illustrates the
major activities that would take place in
preparation for and during
implementation of UCMR 3.
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at each EPTDS. To monitor at
representative EPTDSs, large systems
must meet the reporting criteria
specified in § 141.35(c)(3)(ii), and
receive approval from EPA or the State.
Today’s proposed changes to the rule
language clarify that when identifying a
representative well, the well must be
one of the higher annual volume
producing and consistently active wells.
In addition, should this location go offline, an alternative location must be
sampled.
Reporting Schedule: As under
previous UCMR cycles, large systems
would be responsible for reviewing,
approving, and submitting (i.e.,
‘‘reporting’’) monitoring results to EPA.
To help ensure that monitoring and
reporting is conducted as scheduled,
EPA is proposing that systems must
require their laboratories to post data to
the EPA’s electronic data reporting
system—Safe Drinking Water Accession
and Review System—within 60 days of
sample collection; and that large
systems must review, approve, and
submit the data to the State and EPA
within 30 days of when the laboratory
posts the data. These time frames are
specified in 141.35(c)(6)(ii) and
141.40(a)(5)(vi) and compare to 120
days, and 60 days, (respectively) that
were allowed under UCMR 1 and 2.
With the previous turn-around times, it
was sometimes difficult to ensure
compliance with established monitoring
schedules; these new turnaround times
would reduce the chance of scheduled
monitoring being missed or delayed. If
systems do not electronically approve
the laboratory data within 30 days of the
laboratory’s posting to EPA’s electronic
reporting system, the data would be
considered approved for EPA and State
review. EPA and the State would
conduct its quality control reviews of
the data after the system reports the
data. States would also be given at least
60 days for their quality control review.
After the EPA and State quality control
review, EPA would place the data in the
NCOD at the time of the next database
update, typically three to four times per
year. EPA requests comment on these
shortened reporting timeframes.
Changes to Data Elements and their
Reporting: EPA is proposing two
changes to the data elements listed in
Table 1 of 141.35(e). In addition, EPA is
proposing a related change that would
require systems to report all data
elements with each sample.
• Adding zip code, optional zip code
extension, and zip codes served to Data
Element 4—Sampling Point
Identification Code: This additional
location information is being requested
related to sampling points because
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current information identifying the
location of sampling points is limited.
Zip code of the sampling point would
assist with future vulnerability
assessments. Zip codes tying the
populations served to each sampling
point would assist with future
occurrence and exposure analyses.
• Clarifying and updating the
definition of Data Element 6—
Disinfectant Type: Under UCMR 2, Data
Element 6 was established to provide
information on ‘‘Disinfectant Residual
Type’’ as it related to distribution system
monitoring for nitrosamines (part of
Screening Survey monitoring). EPA is
proposing modification to the definition
of this data element to account for
changes to the analyte and monitoring
specifications between UCMR 2 and
UCMR 3. This revised definition lists
additional disinfectant types to
accommodate recent advances and
changes to disinfectant technologies
being used by water systems, and it
provides that this data element be
reported with all sample results.
• Reporting all data elements with
each sample: Under UCMR 2
Assessment Monitoring, systems were
required to report data elements 1
through 5 and 7 through 15. Data
Element 6 (Disinfectant Residual Type)
was only reported as required by
systems subject to the List 2 Screening
Survey monitoring of nitrosamines in
distribution systems. EPA is proposing
revisions to UCMR that would require
systems to report all data elements with
each sample (including Data Element 6
(Disinfectant Type)) since Assessment
Monitoring within the distribution
system is proposed and since the
information on disinfectant type would
be useful in the Agency’s evaluation of
results for chlorate and the metals on
List 1—Assessment Monitoring and
confirming no disinfection is applied at
systems subject to List 3—Pre-Screen
Testing.
2. Assessment Monitoring
As proposed, Assessment Monitoring
for List 1 contaminants would be
conducted from January 1, 2013 through
December 31, 2015 by all large systems
(those systems serving more than 10,000
people), and by a nationally
representative sample of 800 small
systems (those serving 10,000 people or
fewer). Other than these new monitoring
dates, there are no other changes to the
schedule and frequency of Assessment
Monitoring between UCMR 2 and
UCMR 3. Small systems would be
selected using the same type of
stratified, random selection process as
used in previous UCMRs. Samples
would be collected from the entry point
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to the distribution systems (EPTDSs).
Large ground water systems with
multiple EPTDSs would be permitted to
sample at representative sampling
locations for each ground water source
if those sites have been approved by
EPA or the State. In addition to EPTDS
monitoring, the four metals—cobalt,
molybdenum, vanadium, and
strontium—as well as chlorate, would
be sampled at one distribution system
sampling point per treatment plant (i.e.,
at the distribution system maximum
residence time (DSMRT)). If the
system’s treatment plant/water source is
subject to sampling requirements under
§ 141.132(b)(1) (the Stage 2 Disinfectants
and Disinfection Byproducts Rule),
samples for the metals and chlorate
must be collected at the DSMRT
sampling location(s) identified for that
rule. If a treatment plant/water source is
not subject to the sampling required in
40 CFR 141.132(b)(1), then the
distribution system samples must be
collected at a location that, in the
judgment of the PWS, represents the
maximum residence time in the
distribution system.
Chlorate is being monitored at both
the EPTDS and the DSMRT to determine
the magnitude of chorate increases in
the distribution system. The metals are
monitored at both locations to assess
any potential contribution from the
distribution system. EPA is requesting
comment on DSMRT sampling for the
metals and chlorate.
As under previous UCMR cycles,
samples at ground water locations
would be collected twice during a
designated consecutive 12-month
period. Samples at locations that are fed
in whole or part by a surface water or
ground water under the direct influence
of surface water (GWUDI) source would
be collected quarterly during a
designated consecutive 12-month
period. Large system schedules (year
and months of monitoring) would
initially be determined by EPA in
conjunction with the States (as
described in section III.G. of today’s
action) and these systems would have
an opportunity to modify this schedule.
In today’s proposed action, EPA has
incorporated clarifying revisions in
141.40(a)(4)(i)(B) to specify that large
system monitoring schedules must be
adjusted based on sample point
availability. If it is not possible for a
system to meet its specified sampling
schedule (if, for instance, a particular
sampling point is inactive during the
scheduled sampling timeframe), the
system must notify EPA to reschedule
their sampling. As under previous
UCMR cycles, the Agency would
continue to schedule and coordinate
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small system monitoring, working
closely with partnering States. State
monitoring plans would provide a
venue for States to review and revise the
initial sampling schedules that EPA
proposes (see discussion of State
monitoring plans in section III.G. of
today’s action: ‘‘What is the States’ Role
in the UCMR Program?’’). The 28
proposed List 1 contaminants to be
monitored under Assessment
Monitoring are listed in Exhibit 3, in
section III.B of today’s action.
3. Pre-Screen Testing
As proposed, sampling under the PreScreen Testing for List 3 contaminants
would be conducted from January 1,
2013 through December 31, 2015 by a
targeted sample of 800 PWSs serving
1,000 or fewer people. Sampling would
occur twice during a designated
consecutive 12-month period at each
PWS.
EPA proposes to monitor for
enterovirus and norovirus (as well as
associated pathogen indicators) in
UCMR 3. Both enterovirus and
norovirus are listed on CCL3. EPA
proposes to perform this monitoring
under Pre-Screen Testing at 800 targeted
undisinfected ground water wells from
systems serving 1,000 or fewer
customers that include CWSs,
NTNCWSs and transient noncommunity water systems. This
monitoring is proposed for systems that
serve 1,000 or fewer customers because
these smaller systems are the least likely
to be disinfected, and therefore, would
be most vulnerable to contamination
with viruses. The wells would be
selected from vulnerable areas such as
karst or fractured bedrock. Monitoring
would also include sampling for
pathogen indicators such as total
coliforms, E. coli, bacteriophage,
Enterococci, and aerobic spores. The
objectives of this monitoring are: (1) To
obtain occurrence information to
support regulatory determinations for
enterovirus and norovirus; (2) to gain a
better understanding of pathogen
indicator and viral co-occurrence; and,
(3) to gain more exposure/health risk
information on viruses and indicators.
A summary of the estimated number
of systems to monitor under each UCMR
3 component is listed in Exhibit 5.
EXHIBIT 5—SYSTEMS TO PARTICIPATE IN UCMR 3 MONITORING
System size (number of
people served)
Assessment monitoring for 28 List 1 chemicals
Pre-screen testing for two List 3 microbials 1
Total 2
National sample
Small Systems
25–10,000 .......................
800 randomly selected systems ..........................
800 selected undisinfected ground water wells
from systems serving 1,000 or fewer.
1,600
Large Systems 3
10,001 and over .............
All (4,200) .............................................................
0 ...........................................................................
4,200
Total ........................
5,000 ....................................................................
800 .......................................................................
5,800
srobinson on DSKHWCL6B1PROD with PROPOSALS
1 Sampling for List 3 contaminants to be conducted at 800 undisinfected wells, located in karst or fractured bedrock, in systems serving 1,000
or fewer customers. Monitoring also includes sampling for pathogen indicators: Total coliforms, E. coli, bacteriophage, Enterococci and aerobic
spores. EPA would pay for all sampling and analysis costs associated with virus and pathogen indicator monitoring at these small systems.
2 Total for small systems is additive because these systems would only be selected for one component of UCMR 3 sampling. Number is approximate.
3 Large system counts are approximate.
G. What is the States’ role in the UCMR
program?
Under UCMR 1 and UCMR 2, EPA
described implementation and oversight
activities that States could agree to
through a Partnership Agreement (PA)
process. Because the UCMR is a direct
implementation rule, State participation
is voluntary. Under UCMR 1, specific
activities for individual States were
identified in the rule language.
Beginning with UCMR 2, specific
activities for individual States are
identified and established exclusively
through the PAs, not through rule
language. UCMR 3 would maintain this
previously established process for
UCMR 2.
In compliance with SDWA section
1445(a)(2)(C)(i), the UCMR program
provides a role for States in developing
a representative monitoring plan for
small systems. This is important
because States/primacy agencies most
often have the best information about
PWSs in their State. Through PAs,
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States can help EPA implement the
UCMR program and help ensure that the
UCMR data used for future regulatory
determinations are of the highest quality
possible. EPA would continue to use the
previously established PA structure
during implementation of UCMR 3 to
address the following: The process for
review and revision of the state
monitoring plans; replacing and
updating system information; modifying
timing for monitoring, review and
approval of proposed representative
EPTDS; notification and instructions for
systems; and compliance assistance.
As established under UCMR 1 and 2,
state monitoring plans include tabular
listings of the systems that EPA selected
to conduct monitoring and the EPA
proposed date on which they are to be
sampled. Initial state monitoring plans
also include instructions to States for
revising and/or correcting the state
monitoring plans, including
modifications to sampling schedules for
small systems. EPA incorporates
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revisions from States, and returns the
final state monitoring plans to each
State.
IV. Cost of This Proposed Action
In today’s action, EPA proposes a new
set of contaminants for monitoring in
the third five-year UCMR monitoring
cycle. In addition, UCMR 3 incorporates
modifications to improve the rule
design. UCMR 3 Assessment Monitoring
(for List 1 contaminants) would be
conducted from January 2013 through
December 2015 by 800 systems serving
10,000 or fewer people, and by all
systems serving more than 10,000
people. Eight hundred small systems
would be randomly selected for List 1
monitoring. The Pre-Screen Testing for
List 3 contaminants would also be
conducted from January 2013 through
December 2015 in 800 undisinfected
ground water wells from systems
serving 1,000 or fewer persons. It is
assumed for this cost estimation that
one-third of systems would monitor
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during each of the three monitoring
years.
Labor costs pertain to systems, States,
and EPA. They include activities such
as reading the regulation, notifying
systems selected to participate, sample
collection, data review, reporting, and
recordkeeping. Non-labor costs would
be incurred primarily by EPA and by
large PWSs. They include the cost of
shipping samples to laboratories for
testing and the cost of the actual
laboratory analyses.
In today’s action, EPA proposes six
EPA developed analytical methods and
four equivalent consensus organization
developed methods to monitor for 28
new UCMR 3 chemical contaminants.
While the preamble to this proposed
rule also describes the analytical
methods that would be used for the
proposed virus monitoring, the proposal
does not address these methods.
Laboratory approval for virus
monitoring is not expected to be
necessary since all of the analyses for
the two viruses are expected to be
conducted in laboratories under EPA
contract and at EPA’s expense.
However, estimated system and EPA
costs are based on the analytical costs
for all UCMR 3 methods. With the
exception of Methods 200.8 and 300.1,
these methods are comparatively new
and would not coincide with other
compliance monitoring (i.e., no cost
savings for coincident monitoring can
be realized). Laboratory analysis and
shipping of samples account for
approximately 86% of the total national
cost for UCMR 3 implementation. These
costs are calculated as follows: The
number of systems, multiplied by the
number of sampling locations,
multiplied by the sampling frequency,
multiplied by the unit cost of laboratory
analysis. Under UCMR 3, for List 1
Assessment Monitoring, surface water
(and GWUDI) sampling points would be
monitored four times during the
applicable year of monitoring, and
ground water sample points would be
monitored twice during the applicable
year of monitoring. Systems would
monitor for the four metals—cobalt,
molybdenum, vanadium, and
strontium—as well as chlorate, at their
EPTDS sampling locations and at one
distribution system sampling point per
treatment plant (i.e., at the DSMRT).
Pre-Screen Testing systems would
monitor two times during the three-year
monitoring period (2013 through 2015)
at their EPTDS. EPA estimates of
laboratory fees are based on
consultations with national drinking
water laboratories and a review of the
costs of analytical methods similar to
those proposed in today’s action. The
cost of the Assessment Monitoring
analysis for the UCMR 3 chemicals is
estimated at $1,320 per sample set (at
the EPTDS); the cost of the Pre-Screen
analyses for viruses and related
pathogen indicators (i.e., total coliform,
E. coli, bacteriophage, Enterococci, and
aerobic spores) is estimated at $1,650
per sample set. Shipping estimates are
added to the calculated costs to derive
the total direct analytical non-labor
costs. Estimated shipping costs were
based on the average cost of shipping a
25-pound package.
In preparing the UCMR 3 information
collection request (ICR), EPA relied on
standard assumptions and data sources
used in the preparation of other
drinking water program ICRs. These
include the PWS inventory, number of
sampling points per system, and labor
rates. EPA expects that States would
incur only labor costs associated with
voluntary assistance with UCMR 3
implementation. State costs were
estimated using the relevant modules of
the State Resource Model that was
developed by the Association of State
Drinking Water Administrators
(ASDWA) in conjunction with EPA
(ASDWA, 2003) to help States forecast
resource needs. Model estimates were
adjusted to account for actual levels of
State participation under UCMR 2.
Because State participation would be
voluntary, level of effort would vary
across States and depend on their
individual agreements with EPA.
Over the UCMR implementation
period of 2012–2016, EPA estimates that
nationwide, the average annual cost of
UCMR 3 is approximately $14.9 million.
These total estimated annual costs
(labor and non-labor) are incurred as
follows:
Average annual cost (all
respondents (2012–16))
Respondent
Small Systems (25–10,000), including labor only, non-labor costs paid for by EPA .........................................................
Large Systems (10,001–100,000), including labor and non-labor costs ............................................................................
Very Large Systems (100,001 and greater), including labor and non-labor costs .............................................................
States, including labor costs related to implementation coordination .................................................................................
EPA, including labor for implementation, non-labor for small system testing ....................................................................
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Average Annual National Total ....................................................................................................................................
Additional details regarding EPA’s
cost assumptions and estimates can be
found in the ICR Number 2192.04
amendment prepared for this proposed
rule (Office of Management and Budget
(OMB) number 2040—NEW), which
presents estimated cost and burden for
the 2012–2014 period. Estimates of costs
over the entire third five-year UCMR
cycle of 2012–2016 are attached as an
appendix to the ICR. Copies of the ICR
and its amendment may be obtained
from the EPA public docket for this
proposed rule, which includes this ICR,
under Docket ID Number OW–2004–
0001.
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V. Statutory and Executive Order
Reviews
m
m
m
m
m
14.949 m
summarized in section IV of the
preamble of this proposed rule.
A. Executive Order 12866: Regulatory
Planning and Review
$0.049
8.75
2.1
0.75
3.3
B. Paperwork Reduction Act
Under Executive Order (EO) 12866
(58 FR 51735, October 4, 1993), this
action is a ‘‘significant regulatory
action.’’ Accordingly, EPA submitted
this action to the Office of Management
and Budget (OMB) for review under EO
12866 and any changes made in
response to OMB recommendations
have been documented in the docket for
this action.
In addition, EPA prepared an analysis
of the potential costs associated with
this action. This analysis is briefly
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The information collection
requirements in this proposed rule have
been submitted for approval to the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR)
document prepared by EPA has been
assigned EPA ICR number 2192.04.
The information to be collected under
today’s proposed rule fulfills the
statutory requirements of section
1445(a)(2) of SDWA, as amended in
1996. The data to be collected would
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describe the source of the water,
location, and test results for samples
taken from PWSs. The concentrations of
any identified UCMR contaminants
would be evaluated regarding health
effects and would be considered for
future regulation accordingly. Reporting
is mandatory. The data are not subject
to confidentiality protection.
The annual burden and cost estimates
described in this section are for the
implementation assumptions described
in section IV. Cost and Benefits of the
Rule, in today’s proposed action.
Respondents to the UCMR 3 would
include 1,600 small water systems (800
for Assessment Monitoring, and 800
wells for Pre-Screen Testing), the 4,191
large PWSs, and the 56 States and
Primacy agencies (5,047 total
respondents). The frequency of response
varies across respondents and years.
System costs (particularly laboratory
analytical costs) vary depending on the
number of sampling locations. For cost
estimations, it is assumed that systems
would conduct sampling evenly across
January 2013 through December 2015
(i.e., one-third of systems in each of the
3 consecutive 12-month periods).
Because the applicable ICR period is
2012–2014, there is one year of
monitoring activity (i.e., January
through December of 2015) that is not
captured in the ICR estimates.
Small systems (those serving 10,000
or fewer) that are selected for UCMR 3
monitoring would sample an average of
1.5 times per system (i.e., number of
responses per system) across the threeyear ICR period of 2012–2014. The
average burden per response for small
systems is estimated to be 3.0 hours.
Large systems (those serving 10,001 to
100,000 people) and very large systems
(those serving more than 100,000
people) would sample and report an
average of 2.7 and 3.7 times per system,
respectively, across the three-year ICR
period of 2012–2014. The average
burden per response for large and very
large systems is estimated to be 6.1 and
6.3 hours, respectively. States are
assumed to have an average of 1.0
response per year, related to
coordination with EPA and systems,
with an average burden per response of
184 hours. In aggregate, during the ICR
period of 2012–2014, the average
response (e.g., responses from systems
and States) is associated with a burden
of 8.3 hours, with a labor plus non-labor
cost of $2,714 per response.
The annual average per respondent
burden hours and costs for the ICR
period of 2012–2014 are: small
systems—1.5 hour burden at $34 for
labor; large systems—5.5 hours at $170
for labor, and $2,381 for analytical costs;
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very large systems—7.7 hours at $295
for labor, and $5,460 for analytical costs;
and States—233.4 hours at $13,992 for
labor. Annual average burden and cost
per respondent (including both systems
and States) is estimated to be 8.3 hours,
with a labor plus non-labor cost of
$1,985 per respondent (note that small
systems do not pay for testing costs, and
thus only incur labor costs). Burden is
defined at 5 CFR 1320.3(b).
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in 40
CFR are listed in 40 CFR part 9.
To comment on the Agency’s need for
this information, the accuracy of the
provided burden estimates, and any
suggested methods for minimizing
respondent burden, EPA has established
a public docket for this rule, which
includes this ICR, under Docket ID
number EPA–HQ–OW–2009–0090.
Submit any comments related to the ICR
to EPA and OMB. See ADDRESSES
section at the beginning of this notice
for where to submit comments to EPA.
Send comments to OMB at the Office of
Information and Regulatory Affairs,
Office of Management and Budget, 725
17th Street, NW., Washington, DC
20503, Attention: Desk Office for EPA.
Since OMB is required to make a
decision concerning the ICR between 30
and 60 days after March 3, 2011, a
comment to OMB is best assured of
having its full effect if OMB receives it
by April 4, 2011. The final rule will
respond to any OMB or public
comments on the information collection
requirements contained in this proposal.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
generally requires an agency to prepare
a regulatory flexibility analysis of any
rule subject to notice and comment
rulemaking requirements under the
Administrative Procedure Act or any
other statute unless the agency certifies
that the rule will not have a significant
economic impact on a substantial
number of small entities. Small entities
include small businesses, small
organizations, and small governmental
jurisdictions.
The RFA provides default definitions
for each type of small entity. Small
entities are defined as: (1) A small
business as defined by the Small
Business Administration’s (SBA)
regulations at 13 CFR 121.201; (2) a
small governmental jurisdiction that is a
government of a city, county, town,
school district or special district with a
population of less than 50,000; and (3)
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a small organization that is any ‘‘not-forprofit enterprise which is independently
owned and operated and is not
dominant in its field.’’ However, the
RFA also authorizes an agency to use
alternative definitions for each category
of small entity, ‘‘which are appropriate
to the activities of the agency’’ after
proposing the alternative definition(s) in
the Federal Register and taking
comment (5 U.S.C. 601(3)–(5)). In
addition, to establish an alternative
small business definition, agencies must
consult with SBA’s Chief Counsel for
Advocacy.
For purposes of assessing the impacts
of today’s proposed rule on small
entities, EPA considered small entities
to be PWSs serving 10,000 or fewer
people, because this is the system size
specified in SDWA as requiring special
consideration with respect to small
system flexibility. As required by the
RFA, EPA proposed using this
alternative definition in the Federal
Register, (63 FR 7606, February 13, 1998
(USEPA, 1998a)), requested public
comment, consulted with the SBA, and
finalized the alternative definition in
the Consumer Confidence Reports
rulemaking, (63 FR 44512, August 19,
1998 (USEPA, 1998b)). As stated in that
Final Rule, the alternative definition
would be applied to future drinking
water regulations, including this
regulation.
After considering the economic
impacts of today’s proposed rule on
small entities, I certify that this action
will not have a significant economic
impact on a substantial number of small
entities. The small entities directly
regulated by this proposed rule are
PWSs serving 10,000 or fewer people.
EPA has determined that the small
entities subject to the requirements of
this proposed rule are a subset of the
small PWSs (those serving 10,000 or
fewer people). The Agency has
determined that 1,600 small PWSs
(across Assessment Monitoring and PreScreen Testing), or approximately 3% of
small systems, would experience an
impact of less than 0.4% of revenues;
the remainder of small systems would
not be impacted.
Although this proposed rule will not
have a significant economic impact on
a substantial number of small entities,
EPA nonetheless has tried to reduce the
impact of this rule on small entities. To
ensure that this proposed rule will not
have a significant economic impact on
a substantial number of small entities,
EPA will assume all costs for analyses
of the samples and for shipping the
samples from these systems to the
laboratories contracted by EPA to
analyze UCMR 3 samples. EPA has set
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aside $2.0 million each year from the
State Revolving Fund (SRF) with its
authority to use SRF monies for the
purposes of implementing this
provision of SDWA. Thus, the costs to
these small systems will be limited to
the labor hours associated with
collecting a sample and preparing it for
shipping.
The Agency continues to be interested
in the potential impacts of the proposed
rule on small entities and welcomes
comments on issues related to such
impacts.
The evaluation of the overall impact
on small systems, summarized in the
preceding discussion, is further
described as follows. EPA analyzed the
impacts for privately-owned and
publicly-owned water systems
separately, due to the different
economic characteristics of these
ownership types, such as different rate
structures and profit goals. However, for
both publicly- and privately-owned
systems, EPA used the ‘‘revenue test,’’
which compares annual system costs
attributed to the rule to the system’s
annual revenues. Median revenue data
from the not yet published 2006
Community Water System Survey were
used for public and private water
systems. EPA assumes that the
distribution of the sample of
participating small systems will reflect
the proportions of publicly- and
privately-owned systems in the national
inventory. The estimated distribution of
the representative sample, categorized
by ownership type, source water, and
system size, is presented in Exhibit 6.
EXHIBIT 6—NUMBER OF PUBLICLY- AND PRIVATELY-OWNED SMALL SYSTEMS SUBJECT TO UCMR 3
System size (number of people served)
Publicly-owned
Privately-owned
Total
Ground Water
500 and under ...........................................................................................................
501 to 3,300 ...............................................................................................................
3,301 to 10,000 ..........................................................................................................
126
477
207
378
182
48
504
659
255
Subtotal GW .......................................................................................................
810
608
1,418
500 and under ...........................................................................................................
501 to 3,300 ...............................................................................................................
3,301 to 10,000 ..........................................................................................................
2
35
100
3
13
29
5
48
129
Subtotal SW ........................................................................................................
137
45
182
Total of Small Water Systems ....................................................................
947
653
1,600
Surface Water (and GWUDI)
The basis for the UCMR 3 RFA
certification for this proposed rule is as
follows: for the 1,600 small water
systems that would be affected, the
average annual costs for complying with
this rule represent less than 0.4% of
system revenues (the highest estimated
percentage is for ground water systems
serving 500 or fewer people, at 0.38% of
its median revenue). Exhibit 7 presents
the yearly costs to small systems, and to
EPA for the small system sampling
program, along with an illustration of
system participation for each year of the
UCMR 3 program.
EXHIBIT 7—EPA AND SYSTEMS COSTS FOR IMPLEMENTATION OF UCMR 3 AT SMALL SYSTEMS
Cost description
2012
2013
2014
2015
2016
Total
Costs to EPA for Small System Program (including Assessment Monitoring, and Pre-Screen Testing)
$0
$3,943,827 ................
$3,943,827 ................
$3,943,827 ................
$0
$11,831,481
$0
$245,121
$0
$12,076,599
Costs to Small Systems (including Assessment Monitoring, and Pre-Screen Testing):
$0
$81,707 .....................
$81,707 .....................
$81,707 .....................
Total Costs to EPA and Small Systems for UCMR 2:
$0
$4,025,533 ................
$4,025,533 ................
$4,025,533 ................
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System Monitoring Activity Timeline: 1
Assessment Monitoring.
Pre-Screen Testing.
1 Total
........................
1/3 PWSs Sample .....
1/3 PWSs Sample .....
1/3 PWSs Sample .....
........................
800
........................
1/3 PWSs Sample .....
1/3 PWSs Sample .....
1/3 PWSs Sample .....
........................
800
number of systems is 1,600. No small system conducts more than one type of monitoring study.
System costs are attributed to the
labor required for reading about their
requirements, monitoring, reporting,
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and record keeping. The estimated
average annual burden across the fiveyear UCMR 3 implementation period of
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2012–2016 is estimated to be 1.3 hours
at $31 per small system. Average annual
cost, in all cases, is less than 0.4% of
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system revenues. As required by the
SDWA, the Agency specifically
structured the rule to avoid significantly
affecting small entities by assuming all
costs for laboratory analyses, shipping,
and quality control for small entities. As
a result, EPA incurs the entirety of the
non-labor costs associated with UCMR 3
small system monitoring, or 98% of
total small system testing costs. Exhibits
8 and 9 present the estimated economic
impacts in the form of a revenue test for
publicly- and privately-owned systems.
EXHIBIT 8—UCMR 3 RELATIVE COST ANALYSIS FOR SMALL PUBLICLY-OWNED SYSTEMS (2012–2016)
Annual number of
systems impacted
System size (number of people served)
Average annual
hours per system
(2012–2016)
Average annual
cost per system
(2012–2016)
Revenue test 1
(percent)
Ground Water Systems
500 and under .......................................................................
501 to 3,300 ...........................................................................
3,301 to 10,000 ......................................................................
25
96
41
1.1
1.2
1.7
$22.63
26.84
43.71
0.07
0.02
0.01
1.8
1.9
2.0
38.06
41.99
51.02
0.07
0.02
0.005
Surface Water (and GWUDI) Systems
500 and under .......................................................................
501 to 3,300 ...........................................................................
3,301 to 10,000 ......................................................................
1
7
20
1 The Revenue Test was used to evaluate the economic impact of an information collection on small government entities (e.g., publicly-owned
systems); costs are presented as a percentage of median annual revenue in each size category.
EXHIBIT 9—UCMR 3 RELATIVE COST ANALYSIS FOR SMALL PRIVATELY-OWNED SYSTEMS (2012–2016)
Annual number of
systems impacted
System size (number of people served)
Average annual
hours per system
(2012–2016)
Average annual
cost per system
(2012–2016)
Revenue test 1
(percent)
Ground Water Systems
500 and under .......................................................................
501 to 3,300 ...........................................................................
3,301 to 10,000 ......................................................................
76
36
10
1.1
1.2
1.7
$22.63
26.84
43.71
0.38
0.02
0.004
1.8
1.9
2.0
38.06
41.99
51.02
0.11
0.02
0.005
Surface Water (and GWUDI) Systems
500 and under .......................................................................
501 to 3,300 ...........................................................................
3,301 to 10,000 ......................................................................
1
3
6
1 The ‘‘Revenue Test’’ was used to evaluate the economic impact of an information collection on small private entities (e.g., privately-owned
systems); costs are presented as a percentage of median annual revenue in each size category.
The Agency continues to be interested
in the potential impacts of the proposed
rule on small entities and welcomes
comments on issues related to such
impacts.
srobinson on DSKHWCL6B1PROD with PROPOSALS
D. Unfunded Mandates Reform Act
This rule does not contain a Federal
mandate that may result in expenditures
of $100 million or more for State, local,
and Tribal governments, in the
aggregate, or the private sector in any
one year. Total annual costs of today’s
proposed rule (across the
implementation period of 2012–2016),
for State, local, and Tribal governments
and the private sector, are estimated to
be $14.9 million, of which EPA would
pay $3.3 million, or approximately 22%.
Thus, this rule is not subject to the
requirements of sections 202 or 205 of
UMRA.
This rule is also not subject to the
requirements of section 203 of UMRA
because it contains no regulatory
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requirements that might significantly or
uniquely affect small governments. The
Agency expects to pay for the
reasonable costs of sample analysis for
the small PWSs required to monitor for
unregulated contaminants under this
proposed rule, including those owned
and operated by small governments. The
only costs that small systems would
incur are those attributed to collecting
the UCMR samples and packing them
for shipping to the laboratory (EPA
would pay for shipping). These costs are
minimal. They are not significant or
unique. Thus, today’s rule is not subject
to the requirements of UMRA section
203.
responsibilities among the various
levels of government, as specified in
Executive Order 13132. The cost to State
and local governments is minimal, and
the rule does not preempt State law.
Thus, Executive Order 13132 does not
apply to this action.
In the spirit of Executive Order 13132,
and consistent with EPA policy to
promote communications between EPA
and State and local governments, EPA
specifically solicits comment on the
proposed rule from State and local
officials.
E. Executive Order 13132: Federalism
Subject to the Executive Order 13175
(65 FR 67249, November 9, 2000) EPA
may not issue a regulation that has
Tribal implications, that imposes
substantial direct compliance costs, and
that is not required by statute, unless
the Federal government provides the
This proposed rule does not have
Federalism implications. It will not
have substantial direct effects on the
States, on the relationship between the
national government and the States, or
on the distribution of power and
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F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
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funds necessary to pay the direct
compliance costs incurred by Tribal
governments, or EPA consults with
Tribal officials early in the process of
developing the proposed regulation and
develops a Tribal summary impact
statement.
EPA has concluded that this action
will have Tribal implications. However,
it will neither impose substantial direct
compliance costs on Tribal
governments, nor preempt Tribal law.
As described previously, this proposed
rule requires monitoring by all large
systems (i.e., those serving more than
10,000 people); 17 Tribal water systems
have been identified as large systems
based on information in the SDWIS/Fed
water system inventory. EPA estimates
the average annual cost to each of these
large systems, over the five-year rule
period, to be less than $2,381. This cost
is based on a labor component
(associated with the collection of
samples) and a non-labor component
(associated with shipping and
laboratory fees) and represents less than
0.126% of average revenue/sales for
large systems. UCMR also requires
monitoring by a nationally
representative sample of small systems
(i.e., those serving 10,000 or fewer
people). EPA estimates that
approximately one percent of small
Tribal systems will be selected as a
nationally representative sample for
Assessment Monitoring. EPA estimates
the average annual cost over the fiveyear rule period to be $34. Such cost is
based on the labor associated with
collecting a sample and preparing it for
shipping and represents less than 0.4%
of average revenue/sales for small
systems. All other small-system
expenses (associated with shipping and
laboratory fees) are paid by EPA.
EPA consulted with Tribal officials
early in the process of developing the
UCMR program to permit them to have
meaningful and timely input into its
development. In developing the original
UCMR rule, EPA held stakeholder
meetings and prepared background
information for stakeholder review. EPA
sent requests for review of stakeholder
documents to nearly 400 Tribes, Tribal
organizations, and small systems
organizations to obtain their input.
Representatives from the Indian Health
Service (IHS) Sanitary Deficiency
System and Tribes were consulted
regarding decisions on rule design, the
design for the statistical selection of
small systems, and potential costs.
Tribes raised issues concerning the
selection of the nationally
representative sample of small systems,
particularly the manner in which Tribal
systems would be considered under the
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sample selection process. EPA
developed the sample frame for Tribal
systems and Alaska Native water
systems in response to those concerns.
EPA worked with the Tribes, Alaska
Natives, the IHS, and the States to
determine how to classify each Tribal
system for consideration in the
statistically-based selection of the
nationally representative sample of
small systems. As a result of those
discussions, small PWSs located in
Indian country in each of the EPA
Regions containing Indian country were
evaluated as part of a Tribal category
that receives selection consideration
comparable to that of small systems
outside of Indian country. Thus, Tribal
systems have the same probability of
being selected as other water systems in
the stratified selection process that
weighs systems by water source and size
class by population served. Today’s
proposed rule, addressing the third
UCMR period, maintains the basic
program design of UCMR 1 and 2, and
continues to build upon the structure of
this cyclical program. As part of the
development of this proposed rule, EPA
held a public stakeholder meeting on
April 7, 2010. This meeting was
announced to the public in a Federal
Register notice dated February 23, 2010
(75 FR 8063 (USEPA, 2010a)). Prior to
the meeting, background materials and
rule development information were sent
to specific stakeholders, including
representatives from the Indian Health
Service and the Native American Water
Association.
EPA specifically solicits additional
comment on this proposed action from
tribal officials.
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
This action is not subject to EO 13045
because it does not establish an
environmental standard intended to
mitigate health or safety risks and it is
not an economically significant
regulation pursuant to EO 12866.
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not a ‘‘significant energy
action’’ as defined in Executive Order
13211 (66 FR 28355 (May 22, 2001)),
because it is not likely to have a
significant adverse effect on the supply,
distribution, or use of energy. None of
the proposed UCMR requirements
involve actions that use a measurable
amount of energy.
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I. National Technology Transfer and
Advancement Act
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (‘‘NTTAA’’), Public Law
104–113 (15 U.S.C. 272 note) directs
EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus standards
bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations
when the Agency decides not to use
available and applicable voluntary
consensus standards.
This proposed rulemaking involves
technical standards. EPA proposes to
use the methods developed by the
Agency for the analysis of UCMR 3
contaminants. The Agency conducted a
search of potentially applicable
voluntary consensus standards and
identified three major voluntary
consensus method organizations whose
methods might be acceptable for
determinations under Unregulated
Contaminant Monitoring. These
organizations are Standard Methods,
Association of Analytical Communities
International, and American Society for
Testing and Materials. For the majority
of the parameters included in this
proposed action, EPA was unable to
identify methods from voluntary
consensus method organizations that
were applicable to the monitoring
required. However, EPA identified
acceptable consensus method
organization standards for the analysis
of vanadium, molybdenum, cobalt,
strontium and chlorate. Therefore, EPA
is proposing analytical methods
published by EPA, Standard Methods,
and American Society for Testing and
Materials for these analytes.
EPA welcomes comments on this
aspect of the proposed rulemaking and,
specifically, invites the public to
identify potentially-applicable
voluntary consensus standards and to
explain why such standards should be
used in this regulation.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order (EO) 12898 (59 FR
7629 (Feb. 16, 1994)) establishes Federal
executive policy on environmental
justice. Its main provision directs
Federal agencies, to the greatest extent
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srobinson on DSKHWCL6B1PROD with PROPOSALS
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States.
EPA has determined that this
proposed rule will not have
disproportionately high and adverse
human health or environmental effects
on minority or low-income populations
because it increases the level of
environmental protection for all affected
populations without having any
disproportionately high and adverse
human health or environmental effects
on any population, including any
minority or low-income population. By
seeking to identify unregulated
contaminants that may pose health risks
via drinking water from all PWSs,
UCMR furthers the protection of public
health for all citizens, including
minority and low-income populations
using public water supplies. UCMR uses
a statistically-derived set of systems for
the nationally representative sample
that is population-weighted within each
system size and source water category
so that any PWS within a category has
an equivalent likelihood of selection.
Additionally, EPA is proposing to
require additional reporting elements
that include U.S. Postal Service Zip
Codes for both the finished water entry
point(s) and the PWS’s service area.
EPA is soliciting comment on additional
actions the Agency could take to further
address environmental justice within
the UCMR program. EPA requests
stakeholder input on additional
reporting elements to consider to
support the Agency’s assessment of the
monitoring results. EPA also requests
comments regarding sampling and/or
modeling approaches, and the feasibility
and utility of applying these
approaches, to determine
disproportionate impacts on drinking
water quality at PWSs serving minority
and low-income populations.
VI. Public Involvement in Regulation
Development
EPA’s Office of Ground Water and
Drinking Water has developed a process
for stakeholder involvement in its
regulatory activities for the purpose of
providing early input to regulation
development. When designing and
developing the UCMR program, in the
late 1990s, EPA held meetings for
developing the CCL, establishing the
information requirements of the NCOD,
and selecting priority contaminants for
monitoring. During the initial
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development of the UCMR program,
stakeholders, including PWSs, States,
industry, and other organizations
attended meetings to discuss the UCMR.
Seventeen other meetings were held
specifically concerning UCMR
development. For a description of
public involvement activities related to
the first UCMR (UCMR 1), please see the
discussion in the September 17, 1999
UCMR Final Rule Federal Register at 64
FR 50556 (USEPA, 1999).
Specific to the development of UCMR
3, a stakeholder meeting was held on
April 7, 2010, in Washington, DC. There
were 22 attendees, representing State
agencies, laboratories, PWSs,
environmental groups, and drinking
water associations. The topics of
presentations and discussions included:
Status of UCMR 2; rationale for
developing a new list of potential
contaminants; analytical methods that
could be used in measuring these
contaminants; sampling design;
procedure for determining LCMRLs;
laboratory approval; and other potential
revisions based on lessons learned
during implementation of UCMR 1 and
UCMR 2 (see USEPA, 2010f for
presentation materials, and 2010g for
meeting notes).
EPA has established a public docket
for this rule, under Docket ID No. OW–
2009–0090. EPA is soliciting comments
on this proposed regulation. Please see
the summary section at the beginning of
this notice for instructions on
submitting comments.
VII. References
Ando, T., S.S. Monroe, J.R. Gentsch, Q. Jin,
D.C. Lewis, and R.I. Glass. 1995.
Detection and differentiation of
antigenically distinct small roundstructured viruses (Norwalk-like viruses)
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Needs, and Barriers. April 2003.
ASTM D5673–10. 2010. Standard Test
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Borchardt, M.A. 2008. Wisconsin Water And
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Study)—Part 1: Risk of Illness from
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Washington, DC, December 2–4, 2008.
De Leon, R., C. Shieh, R.S. Baric, and M.D.
Sobsey. 1990. Detection of enteroviruses
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chain reaction. P. 833–835. In Advances
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Francy, D.S., R.N. Bushon, J. Stopar, E.J.
Luzano, and G.S. Fout. 2004.
Environmental Factors and Chemical
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Gibbons, C.D., R.A. Rodriguez., L. Tallon,
M.D. Sobsey. 2010. Evaluation of
positively charged alumina nanofibre
cartridge filters for the primary
concentration of noroviruses,
adenoviruses and male-specific
coliphages from seawater. Journal of
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Jothikumar, N., J.A. Lowther, K.
Henshilwood, D.N. Lees, V.R. Hill, and
J. Vinje´. 2005. Rapid and sensitive
detection of noroviruses by using
TaqMan-based one-step reverse
transcription-PCR assays and application
to naturally contaminated shellfish
samples. Applied and Environmental
Microbiology. 71(4):1870–1875.
Karim, M.R., E.R. Rhodes, N. Brinkman, L.
Wymer, and G.S. Fout. 2009. New
electropositive filter for concentrating
enteroviruses and noroviruses from large
volumes of water. Applied and
Environmental Microbiology. 75(8):2393–
2399.
Lambertini, E., S.K. Spencer, P.D. Bertz, F.J.
Loge, B.A. Kieke, and M.A. Borchardt.
2008. Concentration of enteroviruses,
adenoviruses, and noroviruses from
drinking water by use of glass wool
filters. Applied and Environmental
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Monpoeho, S., A. Dehee, B. Mignotte, L.
Schwartzbrod, V. Marechal, J.C. Nicolas,
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S. Billaudel, and V. Ferre. 2000.
Quantification of enterovirus RNA in
sludge samples by single tube real-time
RT–PCR. BioTechniques. 29:88–95.
SM 3125. 1997. Metals by Inductively
Coupled Plasma/Mass Spectrometry.
Available for purchase on the Internet at
https://www.standardmethods.org/store/
ProductView.cfm?ProductID=211.
SM 4110D. 2000. Determination of Anions by
Ion Chromatography, Part D, IC
determination of oxyhalides and
bromide. Available for purchase on the
Internet at https://
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ProductView.cfm?ProductID=31.
USEPA. 1994. Method 200.8—Determination
of Trace Elements in Waters and Wastes
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by Inductively Coupled Plasma-Mass
Spectrometry. Revision 5.4. Available on
the Internet at https://www.nemi.gov/.
USEPA. 1996. Information Collection Rule
Microbial Laboratory Manual. Office of
Research and Development. April 1996.
EPA/600/R–95/178. Available on the
Internet at https://www.epa.gov/microbes/
online.html#icr.
USEPA. 1997. Method 300.1—Determination
of Inorganic Anions in Drinking Water by
Ion Chromatography. Revision 1.0.
Available on the Internet at https://
water.epa.gov/scitech/drinkingwater/
labcert/analyticalmethods_ogwdw.cfm.
USEPA. 1998a. 40 CFR Parts 141 and 142
National Primary Drinking Water
Regulations: Consumer Confidence;
Proposed Rule. Federal Register. Vol. 63,
No. 30, p. 7606, February 13, 1998.
USEPA. 1998b. 40 CFR Parts 141 and 142
National Primary Drinking Water
Regulation: Consumer Confidence
Reports; Final Rule. Federal Register.
Vol. 63, No. 160, p. 44512, August 19,
1998.
USEPA. 1999. Revisions to the Unregulated
Contaminant Monitoring Regulation for
Public Water Systems; Final Rule.
Federal Register. Vol. 64, No. 180, p.
50556, September 17, 1999.
USEPA. 2001. Statistical Design and Sample
Selection for the Unregulated
Contaminant Monitoring Regulation
(1999). EPA 815–R–01–004. August
2001.
USEPA. 2003. National Primary Drinking
Water Regulations: Stage 2 Disinfectants
and Disinfection Byproducts Rule;
National Primary and Secondary
Drinking Water Regulations: Approval of
Analytical Methods for Chemical
Contaminants. Federal Register. Vol. 68,
No. 159, p. 49547, August 18, 2003.
USEPA. 2004. Statistical Protocol for the
Determination of the Single-Laboratory
Lowest Concentration Minimum
Reporting Level (LCMRL) and Validation
of Laboratory Performance at or Below
the Minimum Reporting Level (MRL).
EPA 815–R–05–006. November 2004.
USEPA. 2007. Unregulated Contaminant
Monitoring Regulation (UCMR) for
Public Water Systems Revisions. Federal
Register. Vol. 72, No. 2, p. 367, January
4, 2007.
USEPA. 2008. Method 522—Determination of
1,4-Dioxane in Drinking Water by Solid
Phase Extraction (SPE) and Gas
Contaminant
Methodology 13
18. Nitrate ..........
Chromatography/Mass Spectrometry
(GC/MS) with Selected Ion Monitoring
(SIM). EPA/600/R–08/101. Version 1.0,
September 2008. Available on the
Internet at https://www.epa.gov/
nerlcwww/ordmeth.htm.
USEPA. 2009a. Method 524.3—Measurement
of Purgeable Organic Compounds in
Water by Capillary Column Gas
Chromatography/Mass Spectrometry.
EPA/815/B–09/009. Version 1.0, June
2009. Available on the Internet at https://
water.epa.gov/scitech/drinkingwater/
labcert/analyticalmethods_ogwdw.cfm.
USEPA. 2009b. Method 537—Determination
of Selected Perfluorinated Alkyl Acids in
Drinking Water by Solid Phase
Extraction and Liquid Chromatography/
Tandem Mass Spectrometry (LC/MS/
MS). EPA/600/R–08/092. Version 1.1,
September 2009. Available on the
Internet at https://www.epa.gov/
nerlcwww/ordmeth.htm.
USEPA. 2009c. Drinking Water Contaminant
Candidate List 3–Final. Federal Register.
Vol. 74, No. 194, p. 51850, October 8,
2009.
USEPA. 2010a. Stakeholder Meeting
Regarding Revisions to the Unregulated
Contaminant Monitoring Regulation.
Federal Register. Vol. 75, No. 35, p.
8063, February 23, 2010.
USEPA. 2010b. 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; Notice. Federal
Register. Vol. 75, No. 59, p. 15500,
March 29, 2010.
USEPA. 2010c. Method 539—Determination
of Hormones in Drinking Water by Solid
Phase Extraction (SPE) and Liquid
Chromatography Electrospray Ionization
Tandem Mass Spectrometry (LC–ESI–
MS/MS). Available on the Internet at
https://water.epa.gov/scitech/
drinkingwater/labcert/
analyticalmethods_ogwdw.cfm.
USEPA. 2010d. Possible Contaminants for
Inclusion on UCMR 3—Information
Compendium. EPA 815–B–10–002.
USEPA. 2010e. UCMR 3 Laboratory Approval
Requirements and Information
Document. Draft in process.
USEPA. 2010f. Stakeholder Meeting
Regarding Revisions to the Unregulated
Contaminant Monitoring Regulation—
Presentation Materials. April 7, 2010.
11731
USEPA. 2010g. Stakeholder Meeting
Regarding Revisions to the Unregulated
Contaminant Monitoring Regulation—
Meeting Notes. April 2010.
List of Subjects
40 CFR Part 141
Environmental protection, Chemicals,
Indians—lands, Intergovernmental
relations, Radiation protection,
Reporting and recordkeeping
requirements, Water supply.
40 CFR Part 142
Environmental protection,
Administrative practices and
procedures, Chemicals, Indian lands,
Radiation protection, Reporting and
recordkeeping requirements, Water
supply.
Dated: February 17, 2011.
Lisa P. Jackson,
Administrator.
For the reasons set out in the
preamble, Title 40, chapter 1 of the
Code of Federal Regulations is proposed
to be amended as follows:
PART 141—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
1. The authority citation for part 141
continues to read as follows:
Authority: 42 U.S.C. 300f, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–4,
300j–9, and 300j–11.
Subpart C—Monitoring and Analytical
Requirements
2. Section 141.23 is amended in the
table to paragraph (k)(1) by revising
entries 18, 19, and 20; and by removing
footnote 23.
The revisions read as follows:
§ 141.23 Inorganic chemical sampling and
analytical requirements.
*
*
*
*
*
(k) Inorganic analysis:
*
*
*
*
*
SM 4 (18th, 19th
ed.)
SM 4 (20th ed.)
*
D4327–97, 03
*
4110 B
*
4110 B
*
4110 B–00
6 353.2
D3867–90 A
D3867–90 B
D6508–00.
D4327–97, 03
4500–NO3-F
4500–NO3-D
4500–NO3-E
4500–NO3F–00
4500–NO3D–00
4500–NO3E–00
7 601
..........................
..........................
6 300.0
19 300.1
6 353.2
..........................
..........................
..........................
6 365.1
4500–NO3F
4500–NO3D
4500–NO3E
4110 B
4110 B
4110 B–00
8 B–1011
4500–NO3F
4500–NO3E
4500–NO2-B
4500–NO3-F
4500–NO3-E
4500–NO2-B
4500–NO3F–00
4500–NO3E–00
4500–NO2-B–00
4500–P F
4500–P F
*
*
Ion Chromatography ......................
EPA Method
*
6 300.0
ASTM 3
SM Online 22
Other
8 B–1011
srobinson on DSKHWCL6B1PROD with PROPOSALS
19 300.1
19. Nitrite ...........
Automated Cadmium Reduction ....
Ion Selective Electrode ..................
Manual Cadmium Reduction .........
Capillary Ion Electrophoresis .........
Ion Chromatography ......................
20. Ortho-phosphate.
Automated Cadmium Reduction ....
Manual Cadmium Reduction .........
Spectrophotometric ........................
Capillary Ion Electrophoresis .........
Colorimetric, Automated, Ascorbic
Acid.
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D3867–90 B
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Methodology 13
EPA Method
Colorimetric, ascorbic acid, single
reagent.
Colorimetric Phosphomolybdate;
Automated-segmented flow; ..........
Automated Discrete .......................
Ion Chromatography ......................
..........................
Contaminant
Capillary Ion Electrophoresis .........
*
*
*
*
*
srobinson on DSKHWCL6B1PROD with PROPOSALS
Book of ASTM Standards, 1994,
1996, 1999, or 2003, Vols. 11.01 and 11.02,
ASTM International; any year containing the
cited version of the method may be used. The
previous versions of D1688–95A, D1688–95C
(copper), D3559–95D (lead), D1293–95 (pH),
D1125–91A (conductivity) and D859–94
(silica) are also approved. These previous
versions D1688–90A, C; D3559–90D, D1293–
84, D1125–91A and D859–88, respectively
are located in the Annual Book of ASTM
Standards, 1994, Vol. 11.01. Copies may be
obtained from ASTM International, 100 Barr
Harbor Drive, West Conshohocken, PA
19428.
4 Standard Methods for the Examination of
Water and Wastewater, 18th edition (1992),
19th edition (1995) or 20th edition (1998).
American Public Health Association, 800 I
Street, NW., Washington, DC 20001–3710.
The cited methods published in any of these
three editions may be used, except that the
versions of 3111 B, 3111 D, 3113 B and 3114
B in the 20th edition may not be used.
5 Method I–2601–90, Methods for Analysis
by the U.S. Geological Survey National Water
Quality Laboratory—Determination of
Inorganic and Organic Constituents in Water
and Fluvial Sediment, Open File Report 93–
125, 1993; For Methods I–1030–85; I–1601–
85; I–1700–85; I–2598–85; I–2700–85; and I–
3300–85. See Techniques of Water Resources
Investigation of the U.S. Geological Survey,
Book 5, Chapter A–1, 3rd edition, 1989;
Available from Information Services, U.S.
Geological Survey, Federal Center, Box
25286, Denver, CO 80225–0425.
6 ‘‘Methods for the Determination of
Inorganic Substances in Environmental
Samples,’’ EPA/600/R–93/100, August 1993.
Available at NTIS, PB94–120821.
7 The procedure shall be done in
accordance with the Technical Bulletin 601
‘‘Standard Method of Test for Nitrate in
Drinking Water,’’ July 1994, PN 221890–001,
Analytical Technology, Inc. Copies may be
obtained from ATI Orion, 529 Main Street,
Boston, MA 02129.
8 Method B–1011. ‘‘Waters Test Method for
Determination of Nitrite/Nitrate in Water
Using Single Column Ion Chromatography,’’
August, 1987. Copies may be obtained from
Waters Corporation, Technical Services
Division, 34 Maple Street, Milford, MA
01757, Telephone: 508/482–2963, Fax: 508/
482–4056.
*
*
*
*
13 Because
MDLs reported in EPA Methods
200.7 and 200.9 were determined using a 2x
preconcentration step during sample
digestion, MDLs determined when samples
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SM 4 (20th ed.)
4500–P E
4500–P E
SM Online 22
Other
5 I–2601–90
5 I–2598–85
6 300.0
D4327–97, 03
19 300.1
..........................
D6508–00
*
3Annual
*
D515–88 A
SM 4 (18th, 19th
ed.)
5 I–1601–85
*
*
ASTM 3
*
4110 B
*
are analyzed by direct analysis (i.e., no
sample digestion) will be higher. For direct
analysis of cadmium and arsenic by Method
200.7, and arsenic by Method 3120 B, sample
preconcentration using pneumatic
nebulization may be required to achieve
lower detection limits. Preconcentration may
also be required for direct analysis of
antimony, lead, and thallium by Method
200.9; antimony and lead by Method 3113 B;
and lead by Method D3559–90D, unless
multiple in-furnace depositions are made.
*
*
*
*
*
for the Determination of
Organic and Inorganic Compounds in
Drinking Water,’’ Vol. 1, EPA 815–R–00–014,
August 2000. Available at NTIS, PB2000–
106981.
19 ‘‘Methods
*
*
*
*
*
22 Standard Methods Online are available
at https://www.standardmethods.org. The year
in which each method was approved by the
Standard Methods Committee is designated
by the last two digits in the method number.
The methods listed are the only online
versions that may be used.
3. Section 141.35 is amended as
follows:
a. In paragraph (a) by revising the
third sentence,
b. By revising paragraph (b)
introductory text,
c. In paragraph (b)(1) by revising the
third sentence,
d. In paragraph (b)(2) by revising the
second sentence,
e. In paragraph (c)(1) by removing
‘‘April 4, 2007’’ and adding in its place,
‘‘[DATE 90 DAYS AFTER DATE OF
PUBLICATION OF THE FINAL RULE],’’
f. In paragraph (c)(2) by removing
‘‘August 2, 2007’’ and adding in its
place, ‘‘[DATE 240 DAYS AFTER DATE
OF PUBLICATION OF THE FINAL
RULE],’’
g. In paragraph (c)(2) by revising the
last sentence,
h. In paragraph (c)(3)(i) by removing
‘‘May 4, 2007’’ and adding in its place,
‘‘[DATE 120 DAYS AFTER DATE OF
PUBLICATION OF THE FINAL RULE],’’
i. In paragraph (c)(3)(ii) by adding a
new second and third sentence,
j. In paragraph (c)(4) by removing
‘‘June 4, 2007’’ and adding in its place,
‘‘[DATE 150 DAYS AFTER DATE OF
PUBLICATION OF THE FINAL RULE],’’
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4110 B
Sfmt 4702
*
4110 B–00
*
k. In paragraph (c)(5)(i) by removing
the two instances of the date ‘‘August 2,
2007’’ and add in their place, ‘‘[DATE
240 DAYS AFTER DATE OF
PUBLICATION OF THE FINAL RULE],’’
l. By revising paragraph (c)(6)
introductory text,
m. By revising paragraph (c)(6)(ii),
n. By revising paragraph (d)(2), and
o. In the table to paragraph (e) by
revising entries 4 and 6.
The revisions and additions read as
follows:
§ 141.35 Reporting for unregulated
contaminant monitoring results.
(a) * * * For the purposes of this
section, PWS ‘‘population served’’ is the
retail population served directly by the
PWS as reported to the Federal Safe
Drinking Water Information System
(SDWIS/Fed).* * *
(b) Reporting by all systems. You must
meet the reporting requirements of this
paragraph if you meet the applicability
criteria in § 141.40(a)(1) and (2).
*
*
*
*
*
(1) * * * Information that must be
submitted using EPA’s electronic data
reporting system must be submitted
through: https://water.epa.gov/lawsregs/
rulesregs/sdwa/ucmr/ucmr3/
reporting.cfm. * * *
(2) * * * If you have received a letter
from EPA concerning your required
monitoring and your system does not
meet the applicability criteria for UCMR
established in § 141.40(a)(1) or (2), or if
a change occurs at your system that may
affect your requirements under UCMR
as defined in § 141.40(a)(3) through (5),
you must fax, mail, or e-mail a letter to
EPA, as specified in paragraph (b)(1) of
this section. * * *
*
*
*
*
*
(c) * * *
(2) * * * If this information changes,
you must report updates, including new
sources and sampling locations which
are put in use before or during the PWS’
UCMR sampling period, to EPA’s
electronic data reporting system within
30 days of the change.
*
*
*
*
*
(3) * * *
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(ii) * * * The proposed
representative well must be one of the
higher annual volume producing and
more consistently active wells in the
representative array. If that
representative well is not in use at the
scheduled sampling time, an alternative
representative well must be sampled.
* * *
*
*
*
*
*
(6) Reporting monitoring results. For
each sample, you must report all data
elements specified in Table 1 of
paragraph (e) of this section, using
EPA’s electronic data reporting system.
You also must report any changes,
relative to what is currently posted,
made to data elements 1 through 6 to
EPA, in writing, explaining the nature
and purpose of the proposed change, as
specified in paragraph (b)(1) of this
section.
*
*
*
*
*
(ii) Reporting schedule. You must
ensure that your laboratory posts the
data to EPA’s electronic data reporting
system within 60 days from the sample
collection date (sample collection must
occur as specified in § 141.40(a)(4)). You
have 30 days from when the laboratory
posts the data in EPA’s electronic data
reporting system to review, approve,
and submit the data to the State and
EPA, at the Web address specified in
paragraph (b)(1) of this section. If you
do not electronically approve and
submit the laboratory data to EPA
within 30 days of the laboratory’s
posting to EPA’s electronic reporting
system, the data will be considered
approved by you and available for State
and EPA review.
*
*
*
*
*
(d) * * *
(2) Reporting sampling information.
You must record all data elements listed
in Table 1 of paragraph (e) of this
section on each sample form and sample
bottle provided to you by the UCMR
Sampling Coordinator. You must send
this information as specified in the
instructions of your sampling kit, which
will include the due date and return
address. You must report any changes
made in data elements 1 through 6 by
mailing or e-mailing an explanation of
the nature and purpose of the proposed
change to EPA, as specified in
paragraph (b)(1) of this section.
(e) * * *
TABLE 1—UNREGULATED CONTAMINANT MONITORING REPORTING REQUIREMENTS
Data element
Definition
*
*
4. (a) Sampling Point Identification Code,
(b) Sampling Point Zip Code, (c) Optional Zip Code Extension, and (d) Zip
Codes Served.
*
*
*
*
*
(a) An identification code established by the State, or at the State’s discretion, by the PWS, that
uniquely identifies each sampling point. Each sampling code must be unique within each applicable
facility, for each applicable sampling location (i.e., entry point to the distribution system or distribution system sample at maximum residence time). The same identification code must be used to
represent the sampling location for all current and future UCMR monitoring.
(b) The U.S. Postal Service (USPS) ZIP code in which the sampling point is located, with format:
ZZZZZ.
(c) The optional Zip Code Extension in which the sampling point is located, with format: EEEE.
(d) Zip codes of all areas supplied with water from this sampling point, with format: ZZZZZ.
*
*
6. Disinfectant Type .................................
*
*
*
*
*
The disinfectant in use at the time of UCMR monitoring. To be reported by systems for each sampling point, with possible values including:
CLG = gaseous chlorine.
CLS = Sodium hypochlorite solution.
CLP = Potassium hypochlorite solution.
CAG = chloramine (gaseous chlorine).
CAS = chloramine (sodium hypochlorite solution).
CAP = chloramine (potassium hypochlorite solution).
CLD = chlorine dioxide.
GOS = Hypochlorite generated off site.
GIH = Hypochlorite generated at DW facility.
OTH = all other types of disinfectant (e.g. ozone).
NOD = no disinfectant used.
*
*
*
srobinson on DSKHWCL6B1PROD with PROPOSALS
Subpart E—Special Regulations,
Including Monitoring Regulations and
Prohibition on Lead Use
4. Section 141.40 is amended as
follows:
a. By revising paragraph (a)
introductory text,
b. By revising paragraph (a)(1),
c. By revising paragraph (a)(2)(i)
introductory text,
d. By revising paragraph (a)(2)(ii)
introductory text,
e. By revising paragraph (a)(2)(ii)(C),
f. By revising paragraph (a)(3),
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16:45 Mar 02, 2011
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*
*
g. In paragraph (a)(4)(i) introductory
text by removing ‘‘August 2, 2007’’ and
adding in its place, ‘‘[DATE 240 DAYS
AFTER DATE OF PUBLICATION OF
THE FINAL RULE],’’
h. By revising paragraph (a)(4)(i)(B),
i. By revising paragraph (a)(4)(i)(C),
j. In paragraph (a)(4)(i)(D) by
removing the last sentence,
k. By revising paragraph (a)(4)(ii)(G),
l. In paragraph (a)(5)(ii) by removing
‘‘April 4, 2007’’ and adding in its place,
‘‘[DATE 90 DAYS AFTER DATE OF
PUBLICATION OF THE FINAL RULE]’’
and by revising the last sentence,
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*
*
m. By revising paragraph (a)(5)(iii)
introductory text,
n. By revising paragraph
(a)(5)(iii)(A)(1),
o. By revising paragraph (a)(5)(iv), and
p. By revising paragraph (a)(5)(vi).
The revisions read as follows:
§ 141.40 Monitoring requirements for
unregulated contaminants.
(a) General applicability. This section
specifies the monitoring and quality
control requirements that must be
followed if you own or operate a public
water system (PWS) that is subject to the
Unregulated Contaminant Monitoring
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Regulation (UCMR), as specified in
paragraphs (a)(1) and (2) of this section.
In addition, this section specifies the
UCMR requirements for State and Tribal
participation. For the purposes of this
section, PWS ‘‘population served,’’
‘‘State,’’ ’’ PWS Official,’’ ‘‘PWS
Technical Contact,’’ and ‘‘finished
water’’ apply as defined in § 141.35(a).
The determination of whether a PWS is
required to monitor under this rule is
based on the type of system (e.g.,
community water system, non-transient
non-community water system, etc.), and
its retail population, as indicated by
SDWIS/Fed on December 31, 2010.
(1) Applicability to transient noncommunity systems. If you own or
operate a transient non-community
water system, you will have to monitor
for the contaminants specified on List 3
of Table 1, in paragraph (a)(3) of this
section if you are notified by your State
or EPA.
(2) * * *
(i) Large systems. If you own or
operate a retail PWS (other than a
transient non-community system) that
serves more than 10,000 people, you
must monitor according to the
specifications in this paragraph (a)(2)(i).
If you believe that your applicability
status is different than EPA has
specified in the notification letter that
you received, or if you are subject to
UCMR requirements and you have not
been notified by either EPA or your
State, you must report to EPA, as
specified in § 141.35(b)(2) or (c)(4).
*
*
*
*
*
(ii) Small systems. Small PWSs, as
defined in this paragraph, will not be
selected to monitor for any more than
one of the three monitoring lists
provided in Table 1, UCMR
Contaminant List, in paragraph (a)(3) of
this section. EPA will provide sample
containers, provide pre-paid air bills for
shipping the sampling materials,
conduct the laboratory analysis, and
report and review monitoring results for
all small systems selected to conduct
monitoring under paragraphs
(a)(2)(ii)(A) through (C) of this section.
If you own or operate a PWS that serves
10,000 or fewer people you must
monitor as follows:
*
*
*
*
*
(C) Pre-Screen Testing. You must
allow EPA or its representative to
collect samples to support monitoring
for the unregulated contaminants on
List 3 of Table 1, in paragraph (a)(3) of
this section, if you are notified by your
State or EPA that you are part of the
State Monitoring plan for Pre-Screen
Testing. In addition, you must permit
the collection of samples as necessary
for EPA to perform analysis for total
coliform, E. coli, bacteriophage,
Enterococci, and aerobic spores.
(3) Analytes to be monitored. Lists 1,
2, and 3 of unregulated contaminants
are provided in the following table:
TABLE 1—UCMR CONTAMINANT LIST
2—CAS
Registry No.
1—Contaminant
3—Analytical
methods a
4—Minimum
reporting level b
5—Sampling
location c
6—Period during which
monitoring to be
completed
List 1: Assessment Monitoring—Chemical Contaminants
Hormones
17-b-estradiol .......................................
17-a-ethynylestradiol ...........................
estriol ...................................................
equilin ..................................................
estrone .................................................
testosterone .........................................
4-androstene-3,17-dione .....................
50–28–2
57–63–6
50–27–1
474–86–2
53–16–7
58–22–0
63–05–8
EPA
EPA
EPA
EPA
EPA
EPA
EPA
539 d
539 d
539 d
539 d
539 d
539 d
539 d
.............
.............
.............
.............
.............
.............
.............
0.0004 μg/L ..........
0.0009 μg/L ..........
0.0008 μg/L ..........
0.004 μg/L ............
0.002 μg/L ............
0.0001 μg/L ..........
0.0003 μg/L ..........
EPTDS
EPTDS
EPTDS
EPTDS
EPTDS
EPDTS
EPTDS
.................
.................
.................
.................
.................
.................
.................
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
EPTDS
EPTDS
EPTDS
EPTDS
EPTDS
EPTDS
EPTDS
EPTDS
EPTDS
.................
.................
.................
.................
.................
.................
.................
.................
.................
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
0.07 μg/L ..............
EPTDS .................
1/1/2013–12/31/2015.
0.2 μg/L ................
EPTDS and
DSMRT.
1/1/2013–12/31/2015.
1. μg/L ..................
EPTDS and
DSMRT.
1/1/2013–12/31/2015.
1. μg/L ..................
EPTDS and
DSMRT.
1/1/2013–12/31/2015.
Volatile Organic Compounds
1,2,3-trichloropropane ..........................
1,3-butadiene .......................................
chloromethane .....................................
1,1-dichloroethane ...............................
n-propylbenzene ..................................
bromomethane .....................................
sec-butylbenzene .................................
chlorodifluoromethane (HCFC–22) ......
bromochloromethane (halon 1011) .....
96–18–4
106–99–0
74–87–3
75–34–3
103–65–1
74–83–9
135–98–8
75–45–6
74–97–5
EPA
EPA
EPA
EPA
EPA
EPA
EPA
EPA
EPA
524.3 e
524.3 e
524.3 e
524.3 e
524.3 e
524.3 e
524.3 e
524.3 e
524.3 e
..........
..........
..........
..........
..........
..........
..........
..........
..........
0.03 μg/L ..............
0.1 μg/L ................
0.2 μg/L ................
0.03 μg/L ..............
0.03 μg/L ..............
0.2 μg/L ................
0.04 μg/L ..............
0.08 μg/L ..............
0.06 μg/L ..............
Synthetic Organic Compound
1,4-dioxane ..........................................
123–91–1
EPA 522 f .............
Metals
srobinson on DSKHWCL6B1PROD with PROPOSALS
vanadium .............................................
7440–62–2
molybdenum ........................................
7439–98–7
cobalt ...................................................
7440–48–4
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EPA 200.8 ............
ASTM ...................
D5673–10 ............
SM 3125 g ............
EPA 200.8 ............
ASTM ...................
D5673–10 ............
SM 3125 g ............
EPA 200.8 ............
ASTM ...................
D5673–10 ............
SM 3125 g ............
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Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Proposed Rules
11735
TABLE 1—UCMR CONTAMINANT LIST—Continued
1—Contaminant
2—CAS
Registry No.
3—Analytical
methods a
4—Minimum
reporting level b
strontium ..............................................
7440–24–6
EPA 200.8 ............
ASTM ...................
D5673–10 ............
SM 3125 g ............
0.3 μg/L ................
5—Sampling
location c
6—Period during which
monitoring to be
completed
EPTDS and
DSMRT.
1/1/2013–12/31/2015.
EPTDS and
DSMRT.
1/1/2013–12/31/2015.
EPTDS
EPTDS
EPTDS
EPTDS
EPTDS
EPTDS
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
Oxyhalide Anion
Chlorate ...............................................
14866–68–3
EPA 300.1 ............
ASTM D ...............
6581–08 ...............
SM 4110D h ..........
20 μg/L .................
Perfluorinated Compounds
perfluorooctane sulfonic acid (PFOS)
perfluorooctanoic acid (PFOA) ............
perfluorononanoic acid (PFNA) ...........
perfluorohexane sulfonic acid (PFHxS)
perfluoroheptanoic acid (PFHpA) ........
perfluorobutanesulfonic acid (PFBS) ...
1763–23–1
335–67–1
375–95–1
355–46–4
375–85–9
375–73–5
EPA
EPA
EPA
EPA
EPA
EPA
537 i
537 i
537 i
537 i
537 i
537 i
.............
.............
.............
.............
.............
.............
0.04
0.02
0.02
0.03
0.01
0.09
μg/L
μg/L
μg/L
μg/L
μg/L
μg/L
..............
..............
..............
..............
..............
..............
.................
.................
.................
.................
.................
.................
List 2: Screening Survey
Reserved ..............................................
Reserved
Reserved ..............
Reserved ..............
Reserved ..............
Reserved.
List 3: Pre-Screen Testing—Microbiological Contaminants
srobinson on DSKHWCL6B1PROD with PROPOSALS
enteroviruses .......................................
noroviruses ..........................................
N/A
N/A
Column headings are:
1—Contaminant: the name of the
contaminant to be analyzed.
2—CAS (Chemical Abstract Service)
Registry Number or Identification
Number: a unique number identifying
the chemical contaminants.
3—Analytical Methods: method
numbers identifying the methods that
must be used to test the contaminants.
For List 3, analysis will only be
performed by laboratories under
contract to EPA.
4—Minimum Reporting Level: the
value and unit of measure at or above
which the concentration of the
contaminant must be measured using
the approved analytical methods. For
List 3, minimum reporting level is based
on volume of water filtered and PCR
amplification level.
5—Sampling Location: the locations
within a PWS at which samples must be
collected.
6—Period During Which Monitoring
to be Completed: the time period during
which the sampling and testing are to
occur for the indicated contaminant.
on how to obtain these documents can be
provided by the Safe Drinking Water Hotline
at (800) 426–4791. Documents may be
inspected at EPA’s Drinking Water Docket,
1301 Constitution Avenue, NW., EPA West,
Room 3334, Washington, DC 20460,
Telephone: (202) 566–2426; or at the
National Archives and Records
Administration (NARA). For information on
availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/Federal-register/cfr/
index.html. The version of the EPA methods
which you must follow for this Regulation
are listed in footnotes d through i as follows:
b The minimum reporting level (MRL) is
the minimum concentration of each analyte
that must be reported to EPA.
c Sampling must occur at entry points to
the distribution system (EPTDSs) after
treatment is applied that represent each nonemergency water source in routine use over
the 12-month period of monitoring. Systems
that purchase water with multiple
connections from the same wholesaler may
propose one representative connection from
that wholesaler. This representative EPTDS
sampling location must be one of the higher
annual volume connections. If the
connection selected as the representative
EPTDS is not available for sampling, an
alternate representative connection must be
sampled. See 40 CFR 141.35(c)(3) for an
explanation of the requirements related to
use of representative ground water EPTDSs.
Sampling for metals and chlorate at
disinfection byproduct distribution system
maximum residence time (DSMRT) sampling
locations as defined in 40 CFR
a The analytical procedures shall be
performed in accordance with the documents
associated with each method (per the
following footnotes). The incorporation by
reference of the following documents listed
in footnotes d–i was approved by the Director
of the Federal Register in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Information
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N/A .......................
N/A .......................
Frm 00052
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N/A .......................
N/A .......................
Sfmt 4702
EPTDS .................
EPTDS .................
1/1/2013–12/31/2015.
1/1/2013–12/31/2015.
141.132(b)(1)(i). If a treatment plant/water
source is not subject to the sampling required
in 40 CFR 141.132(b)(1), then the distribution
system samples for metals must be collected
at a location that the system determines
represents the maximum residence time in
the distribution system.
d EPA Method 539 ‘‘Determination of
Hormones in Drinking Water Using Liquid
Chromatography Tandem Mass
Spectrometry,’’ is available at https://
water.epa.gov/scitech/drinkingwater/labcert/
analyticalmethods_ogwdw.cfm.
e EPA Method 524.3 ‘‘Measurement of
Purgeable Organic Compounds in Water by
Capillary Column Gas Chromatography/Mass
Spectrometry,’’ Version 1.0, June 2009 is
available at https://water.epa.gov/scitech/
drinkingwater/labcert/
analyticalmethods_ogwdw.cfm.
f EPA Method 522 ‘‘Determination of 1,4–
Dioxane in Drinking Water by Solid Phase
Extraction (SPE) and Gas Chromatography/
Mass Spectrometry (GC/MS) with Selective
Ion Monitoring (SIM),’’ Version 1.0,
September 2008 is available at https://
www.epa.gov/nerlcwww/ordmeth.htm.
g EPA Method 200.8 ‘‘Determination of
Trace Elements in Waters and Wastes by
Inductively Coupled Plasma-Mass
Spectrometry,’’ Version 5.4, 1994 is available
at https://www.NEMI.gov.
ASTM D5673–10. Standard Test Method
for Elements in Water by Inductively
Coupled Plasma-Mass Spectrometry.
Available for purchase on the Internet at
https://www.astm.org/Standards/D5673.htm.
SM 3125. Metals by Inductively Coupled
Plasma/Mass Spectrometry (1997). Available
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for purchase on the Internet at https://
www.standardmethods.org/store/
ProductView.cfm?ProductID=211.
h EPA Method 300.1 ‘‘Determination of
Inorganic Anions in Drinking Water by Ion
Chromatography,’’ Revision 1.0, 1997 is
available at https://water.epa.gov/scitech/
drinkingwater/labcert/
analyticalmethods_ogwdw.cfm.
ASTM D6581–08. Standard Test Methods
for Bromate, Bromide, Chlorate, and Chlorite
in Drinking Water by Suppressed Ion
Chromatography. Available for purchase on
the Internet at https://www.astm.org/
Standards/D6581.htm.
SM 4110D. Determination of Anions by Ion
Chromatography, Part D, Ion
Chromatography Determination of
Oxyhalides and Bromide. Available for
purchase on the Internet at https://
www.standardmethods.org/store/
ProductView.cfm?ProductID=31.
i EPA Method 537 ‘‘Determination of
Selected Perfluorinated Alkyl Acids in
Drinking Water by Solid Phase Extraction
and Liquid Chromatography/Tandem Mass
Spectrometry,’’ Version 1.1, September 2009
is available at https://www.epa.gov/nerlcwww/
ordmeth.htm.
*
*
*
*
*
(4) * * *
(i) * * *
(B) Frequency. You must collect the
samples within the time frame and
according to the frequency specified by
contaminant type and water source type
for each sampling location, as specified
in Table 2, in this paragraph. For the
second or subsequent round of
sampling, if a sample location is nonoperational for more than one month
before and one month after the
scheduled sampling month (i.e., it is not
possible for you to sample within the
window specified in Table 2, in this
paragraph), you must notify EPA as
specified in § 141.35(c)(5) to reschedule
your sampling.
TABLE 2—MONITORING FREQUENCY BY CONTAMINANT AND WATER SOURCE TYPES
Contaminant type
Water source type
Time frame
Frequency
Chemical ....................
Surface water or ground water under the direct influence of surface
water (GWUDI) (includes all sampling locations for which some or
all of the water comes from a surface water or GWUDI source at
any time during the 12 month monitoring period).
Ground water ......................................................................................
12 months ...
You must monitor for 4 consecutive quarters. Sample events
must occur 3 months apart.
12 months ...
Ground water ......................................................................................
12 months ...
You must monitor twice in a consecutive
12-month
period.
Sample events must occur 5–7
months apart.
You must monitor twice in a consecutive
12-month
period.
Sample events must occur 5–7
months apart.
srobinson on DSKHWCL6B1PROD with PROPOSALS
Microbiological ...........
(C) Location. You must collect
samples for each List 1 Assessment
Monitoring contaminant, and, if
applicable, for each List 2 Screening
Survey, or List 3 Pre-Screen Testing
contaminant, as specified in Table 1, in
paragraph (a)(3) of this section. Samples
must be collected at each sample point
that is specified in column 5 and
footnote c of Table 1, in paragraph (a)(3)
of this section. If you are a ground water
system with multiple EPTDSs, and you
request and receive approval from EPA
or the State for sampling at
representative EPTDS(s), as specified in
§ 141.35(c)(3), you must collect your
samples from the approved
representative sampling location(s).
Systems conducting Assessment
Monitoring must also sample for metals
and chlorate at the disinfection
byproduct distribution system
maximum residence time (DSMRT)
sampling location(s) if they are subject
to sampling requirements in
§ 141.132(b)(1). If a treatment plant/
water source is not subject to the
sampling required in 40 CFR
141.132(b)(1), then the distribution
system samples must be collected at a
location that the system determines
represents the maximum residence time
in the distribution system.
(ii) * * *
*
*
*
*
*
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(G) Sampling forms. You must
completely fill out each of the sampling
forms and bottles sent to you by the
UCMR Sampling Coordinator, including
data elements listed in § 141.35(e) for
each sample, as specified in
§ 141.35(d)(2). You must sign and date
the sampling forms.
*
*
*
*
*
(5) * * *
*
*
*
*
*
(ii) * * * Correspondence must be
addressed to: UCMR Laboratory
Approval Coordinator, USEPA,
Technical Support Center, 26 West
Martin Luther King Drive, (MS 140),
Cincinnati, OH 45268; or e-mailed to
EPA at: UCMR_Sampling
_Coordinator@epa,gov.
(iii) Minimum Reporting Level. The
MRL is an estimate of the quantitation
limit that, with 95% confidence, is
achievable by a capable analyst/
laboratory at least 75% of the time.
Assuming good instrumentation and
experienced analysts, with 95%
confidence, an MRL is achievable by
75% of laboratories nationwide.
(A) * * *
(1) All laboratories performing
analysis under UCMR must demonstrate
that they are capable of meeting data
quality objectives (DQOs) at or below
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the MRL listed in Table 1, column 4, in
paragraph (a)(3) of this section.
*
*
*
*
*
(iv) Laboratory fortified sample matrix
and laboratory fortified sample matrix
duplicate. You must ensure that your
laboratory prepares and analyzes the
Laboratory Fortified Sample Matrix
(LFSM) sample for accuracy and
Laboratory Fortified Sample Matrix
Duplicate (LFSMD) samples for
precision to determine method accuracy
and precision for all contaminants in
Table 1, in paragraph (a)(3) of this
section. LFSM/LFSMD samples must be
prepared using a sample collected and
analyzed in accordance with UCMR
requirements and analyzed at a
frequency of 5% (or 1 LFSM/LFSMD set
per every 20 samples) or with each
sample batch, whichever is more
frequent. In addition, the LFSM/LFSMD
fortification concentrations must be
alternated between a low-level
fortification and mid-level fortification
approximately 50% of the time. (For
example: a set of 40 samples will
require preparation and analysis of 2
LFSM/LFSMD paired samples. The first
LFSM/LFSMD paired sample set must
be fortified at either the low-level or
mid-level, and the second LFSM/
LFSMD paired sample set must be
fortified with the other standard, either
the low-level or mid-level, whichever
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Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Proposed Rules
was not used for the initial LFSM/
LFSMD paired sample set.) The lowlevel LFSM/LFSMD fortification
concentration must be within ±50% of
the MRL for each contaminant (e.g., for
an MRL of 1 μg/L the acceptable
fortification levels must be between 0.5
μg/L and 1.5 μg/L). The mid-level
LFSM/LFSMD fortification
concentration must be within ±20% of
the mid-level calibration standard for
each contaminant, and should
represent, where possible and where the
laboratory has data from previously
analyzed samples, an approximate
average concentration observed in
previous analyses of that analyte. There
are no UCMR contaminant recovery
acceptance criteria specified for LFSM/
LFSMD analyses. All LFSM/LFSMD
data are to be reported.
*
*
*
*
*
(vi) Reporting. You must require your
laboratory to submit these data
electronically to the State and EPA
using EPA’s electronic data reporting
system, accessible at (https://
water.epa.gov/lawsregs/rulesregs/sdwa/
ucmr/ucmr3/reporting.cfm), within 60
days from the sample collection date.
You then have 30 days from when the
laboratory posts the data to review,
approve and submit the data to the State
and EPA, via EPA’s electronic data
reporting system. If you do not
electronically approve and submit the
laboratory data to EPA within 30 days
of the laboratories posting to EPA’s
electronic reporting system, the data
will be considered approved and
available for State and EPA review.
*
*
*
*
*
PART 142—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
IMPLEMENTATION
5. The authority citation for part 142
continues to read as follows:
Authority: 42 U.S.C. 300f, 300g–1, 300g–
2, 300g–3, 300g–4, 300g–5, 300g–6, 300j–4,
300j–9, and 300j–11.
srobinson on DSKHWCL6B1PROD with PROPOSALS
Subpart B—Primary Enforcement
Responsibility
6. Section 142.16 is amended as
follows:
a. In paragraph (j) introductory text by
removing ‘‘§ 141.40’’.
b. In paragraph (j)(1) by revising the
first sentence.
§ 142.16
Special primacy requirements.
*
*
*
*
*
(j) * * *
(1) If a State chooses to issue waivers
from the monitoring requirements in
§§ 141.23 and 141.24, the State shall
describe the procedures and criteria
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16:45 Mar 02, 2011
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which it will use to review waiver
applications and issue wavier
determinations. * * *
*
*
*
*
*
[FR Doc. 2011–4641 Filed 3–2–11; 8:45 am]
BILLING CODE 6560–50–P
11737
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 090225241–0561–02]
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[MB Docket No. 10–108; Report No. 2925]
Petition for Reconsideration of Action
of Rulemaking Proceeding
Federal Communications
Commission.
ACTION: Petition for reconsideration.
AGENCY:
In this document, a Petition
for Reconsideration (Petition) has been
filed in the Commission’s Rulemaking
proceeding listed in this document
(Table of Allotments, FM Broadcast
Stations (Pacific Junction, Iowa)).
DATES: Oppositions to the Petition must
be filed by March 18, 2011. Replies to
an opposition must be filed March 28,
2011.
ADDRESSES: Federal Communications
Commission, 445 12th Street, SW.,
Washington, DC.
FOR FURTHER INFORMATION CONTACT:
Andrew J. Rhodes, Media Bureau, (202)
418–2180.
SUPPLEMENTARY INFORMATION: This is a
summary of Commission’s document,
Report No. 2925, released February 7,
2011. The full text of this document is
available for viewing and copying in
Room CY–B402, 445 12th Street, SW.,
Washington, DC or may be purchased
from the Commission’s copy contractor,
Best Copy and Printing, Inc. (BCPI) (1–
800–378–3160). The Commission will
not send a copy of this Notice pursuant
to the Congressional Review Act, 5
U.S.C. 801(a)(1)(A), because this Notice
does not have an impact on any rules of
particular applicability.
This document is published pursuant
to 47 CFR 1.429(e). See 1.4(b)(1) of the
Commission’s rules (47 CFR 1.4(b)(1)).
Subject: In the Matter of Amendment
of Section 73.202(b), Table of
Allotments, FM Broadcast Stations
(Pacific Junction, Iowa) (MB Docket No.
10–108).
Number of Petitions Filed: 1.
SUMMARY:
Federal Communications Commission.
Bulah P. Wheeler,
Deputy Manager, Office of the Secretary,
Office of Managing Director.
[FR Doc. 2011–4687 Filed 3–2–11; 8:45 am]
BILLING CODE 6712–01–P
PO 00000
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RIN 0648–AX70
Fisheries of the Northeastern United
States; Monkfish; Amendment 5
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; amendment;
request for comments.
AGENCY:
NMFS proposes regulations to
implement measures in Amendment 5
to the Monkfish Fishery Management
Plan (Monkfish FMP). The New England
and Mid-Atlantic Fishery Management
Councils (Councils) developed
Amendment 5 to bring the Monkfish
FMP into compliance with the annual
catch limit (ACL) and accountability
measure (AM) requirements of the
Magnuson-Stevens Fishery
Conservation and Management Act
(Magnuson-Stevens Act). NMFS is
considering disapproving proposed
annual catch targets (ACT) that are not
consistent with the most recent
scientific advice. This proposed rule
also proposes three management
measures in Amendment 5 to promote
efficiency and reduce waste: Automatic
days-at-sea (DAS) adjustment for trip
limit overages; authorization to land
monkfish heads; and enable changes to
the Monkfish Research Set-Aside (RSA)
Program through framework adjustment,
and to bring the biological and
management reference points in the
Monkfish FMP into compliance with
recently revised National Standard 1
(NS1) Guidelines.
DATES: Public comments must be
received no later than 5 p.m., eastern
standard time, on April 4, 2011.
ADDRESSES: An environmental
assessment (EA) was prepared for
Amendment 5 that describes the
proposed action and other considered
alternatives, and provides a thorough
analysis of the impacts of the proposed
measures and alternatives. Copies of
Amendment 5, including the EA and the
Initial Regulatory Flexibility Analysis
(IRFA), are available on request from
Paul J. Howard, Executive Director, New
England Fishery Management Council
(Council), 50 Water Street,
Newburyport, MA 01950. These
documents are also available online at
https://www.nefmc.org.
SUMMARY:
E:\FR\FM\03MRP1.SGM
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Agencies
[Federal Register Volume 76, Number 42 (Thursday, March 3, 2011)]
[Proposed Rules]
[Pages 11713-11737]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4641]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 141 and 142
[Docket No. OW-2009-0090; FRL-9274-2]
RIN 2040-AF10
Revisions to the Unregulated Contaminant Monitoring Regulation
(UCMR 3) for Public Water Systems
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The 1996 amendments to the Safe Drinking Water Act (SDWA)
require that the United States Environmental Protection Agency (EPA or
the Agency) establish criteria for a program to monitor unregulated
contaminants and to publish a list of contaminants to be monitored
every five years. This action meets the SDWA requirement by proposing
the design for the third UCMR cycle (i.e., UCMR 3). EPA is proposing
six EPA-developed analytical methods, and four equivalent consensus
organization-developed methods to monitor for 28 new UCMR chemical
contaminants. In addition, EPA proposes monitoring for two viruses, for
a total of 30 UCMR 3 contaminants. As envisioned, virus analysis (along
with related analysis for pathogen indicators) would be conducted in
laboratories under EPA contract. UCMR 3 provides EPA and other
interested parties with scientifically valid data on the occurrence of
these contaminants in drinking water, permitting the assessment of the
number of people potentially being exposed and the levels of that
exposure. These data are the primary source of occurrence and exposure
information the Agency uses to determine whether to regulate these
contaminants. In addition, as part of an Expedited Methods Update, this
proposed action also would amend regulations concerning inorganic
chemical sampling and analytical requirements. A minor editorial
correction to the table moves methods from the ``Other'' column to the
``ASTM'' column, as it applies to the inorganic chemical sampling and
analytical requirements. The UCMR program is not affected by these
changes.
DATES: Comments must be received on or before May 2, 2011.
ADDRESSES: Submit your comments, identified by Docket ID No. OW-2009-
0090, by one of the following methods:
https://www.regulations.gov. Follow the on-line
instructions for submitting comments.
E-mail: OW-Docket@epa.gov.
Mail: Send three copies of your comments and any
enclosures to: Water Docket, United States Environmental Protection
Agency, Mail Code 282211T, 1200 Pennsylvania Avenue, NW., Washington,
DC 20460, Attention Docket ID No. OW-2009-0090. Commenters should use a
separate paragraph for each issue discussed. In addition, please mail a
copy of your comments on the information collection provisions to the
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), Attn: Desk Officer for EPA, 725 17th St., NW.,
Washington, DC 20503.
Hand Delivery: Deliver your comments to Water Docket, EPA
Docket Center, Environmental Protection Agency, Room 3334, 1301
Constitution Ave., NW., Washington, DC, Attention Docket ID No. OW-
2009-0090. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. EPA-OW-2009-
0090. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through https://www.regulations.gov or e-mail. The https://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through https://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
[[Page 11714]]
Docket: All documents in the docket are listed in the https://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in https://www.regulations.gov or in hard copy at the Water Docket, EPA/
DC, EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC.
This Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is (202) 566-1744, and the Water Docket is (202)
566-2426.
FOR FURTHER INFORMATION CONTACT: David J. Munch, Technical Support
Center, Office of Ground Water and Drinking Water, United States
Environmental Protection Agency, Office of Water, 26 West Martin Luther
King Drive (MS 140), Cincinnati, OH 45268; telephone (513) 569-7843; or
e-mail at munch.dave@epa.gov; or Brenda D. Parris, Technical Support
Center, Office of Ground Water and Drinking Water, United States
Environmental Protection Agency, Office of Water, 26 West Martin Luther
King Drive (MS 140), Cincinnati, Ohio 45268; telephone (513) 569-7961;
or e-mail at parris.brenda@epa.gov. For general information, contact
the Safe Drinking Water Hotline. Callers within the United States may
reach the Hotline at (800) 426-4791. The Hotline is open Monday through
Friday, excluding legal holidays, from 10 a.m. to 4 p.m., Eastern time.
The Safe Drinking Water Hotline may also be found on the Internet at:
https://water.epa.gov/aboutow/ogwdw/hotline/.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
Entities regulated by this action are public water systems (PWSs).
All large community and non-transient non-community water systems
serving more than 10,000 people would be required to monitor. A
community water system (CWS) means a PWS which has at least 15 service
connections used by year-round residents or regularly serves an average
of at least 25 year-round residents. A non-transient non-community
water system (NTNCWS) means a PWS that is not a CWS and that regularly
serves at least 25 of the same people over six months per year. Only a
nationally representative sample of community and non-transient non-
community systems serving 10,000 or fewer people would be required to
monitor for chemical analytes (see USEPA, 2001 for a description of the
statistical approach for the nationally representative sample).
Transient non-community systems (i.e., systems that do not regularly
serve at least 25 of the same people over six months per year) would
not be required to monitor for the chemical analytes. However,
transient ground water systems serving 1,000 or fewer would be subject
to possible selection for virus monitoring. If selected, these systems
would be required to permit EPA to sample and analyze for List 3
contaminants and pathogen indicators. EPA would pay for all sampling
and analysis costs associated with virus monitoring at these small
systems. States, Territories, and Tribes with primary enforcement
responsibility (primacy) to administer the regulatory program for PWSs
under the Safe Drinking Water Act (SDWA) may participate in the
implementation of UCMR 3 through Partnership Agreements (PAs) (see
discussion of PAs in section III.G. of today's action: ``What Is the
States' Role in the UCMR Program?''). These primacy agencies may choose
to conduct analyses to measure for contaminants in water samples
collected for the UCMR 3; however, the PWS remains responsible for
compliance. Regulated categories and entities are identified in the
following table.
----------------------------------------------------------------------------------------------------------------
Category Examples of potentially regulated entities NAICS \a\
----------------------------------------------------------------------------------------------------------------
State, Local, & Tribal Governments....... States, local and Tribal governments that analyze 924110
water samples on behalf of public water systems
required to conduct such analysis; States, local and
Tribal governments that directly operate community,
transient and non-transient non-community water
systems required to monitor.
Industry................................. Private operators of community and non-transient non- 221310
community water systems required to monitor.
Municipalities........................... Municipal operators of community and non-transient 924110
non-community water systems required to monitor.
----------------------------------------------------------------------------------------------------------------
\a\ NAICS = North American Industry Classification System.
This table is not exhaustive, but rather provides a guide for
readers regarding entities likely to be regulated by this action. This
table lists the types of entities that EPA is now aware may potentially
be regulated by this action. Other types of entities not listed in the
table could also be regulated. To determine whether your facility is
regulated by this action, you should carefully examine the definition
of PWS in Sec. 141.2 of Title 40 of the Code of Federal Regulations,
and applicability criteria in Sec. 141.40(a)(1) and (2) of today's
proposed action. If you have questions regarding the applicability of
this action to a particular entity, consult the persons listed in the
preceding FOR FURTHER INFORMATION CONTACT section.
B. Copies of This Document and Other Related Information
This document is available for download at: https://www.regulations.gov. For other related information, see preceding
discussion on docket.
Abbreviations and Acronyms
[micro]g/L Microgram per liter
ASDWA Association of State Drinking Water Administrators
ASTM American Society for Testing Materials
CBI Confidential Business Information
CCL Contaminant Candidate List
CFR Code of Federal Regulations
CWS Community water system
DSMRT Distribution system maximum residence time
EPA United States Environmental Protection Agency
EPTDS Entry point to the distribution system
FR Federal Register
GC/MS Gas Chromatography/Mass Spectrometry
GWUDI Ground water under the direct influence of surface water
HCFC-22 Chlorodifluoromethane
IC/MS Ion Chromatography/Mass Spectrometry
ICR Information collection request
IHS Indian Health Service
LCMRL Lowest concentration minimum reporting level
LC/MS/MS Liquid Chromatography/Tandem Mass Spectrometry
LFSM Laboratory fortified sample matrix
LFSMD Laboratory fortified sample matrix duplicate
MRL Minimum reporting level
[[Page 11715]]
NAICS North American Industry Classification System
NCOD National Drinking Water Contaminant Occurrence Database
NPDWR National primary drinking water regulation
NTNCWS Non-transient non-community water system
NTTAA National Technology Transfer and Advancement Act
OMB Office of Management and Budget
PA Partnership Agreement
PFBS Perfluorobutanesulfonic acid
PFHpA Perfluoroheptanoic acid
PFHxS Perfluorohexane sulfonic acid
PFNA Perfluorononanoic acid
PFOA Perfluorooctanoic acid
PFOS Perfluorooctane sulfonic acid
PT Proficiency testing
PWS Public water system
qPCR Quantitative polymerase chain reaction
RFA Regulatory Flexibility Act
SM Standard Methods
SRF State Revolving Fund
SBA Small Business Administration
SDWA Safe Drinking Water Act
SDWIS/Fed Federal Safe Drinking Water Information System
UCMR Unregulated Contaminant Monitoring Regulation
UMRA Unfunded Mandates Reform Act of 1995
USEPA United States Environmental Protection Agency
VOC Volatile Organic Compound
Table of Contents
I. General Information
A. Does this action apply to me?
B. Copies of This Document and Other Related Information
II. Statutory Authority and Background
A. What is the statutory authority for this action?
B. How does EPA meet these statutory requirements?
C. How are the contaminant candidate list, the National
Contaminant Occurrence Database, and the UCMR interrelated?
III. Requirements of the Unregulated Contaminant Monitoring Program
A. What are the changes being proposed for UCMR 3?
B. What priority contaminants were selected for UCMR 3?
1. Twenty Eight Chemicals
2. Two Viruses
C. How Were minimum reporting levels determined?
D. How would laboratories conduct UCMR analyses?
E. What are the new applicability considerations?
1. Applicability Based on Population Served
2. Applicability for Transient Systems
F. UCMR 3 Timeline and Sampling Design Considerations
1. UCMR 3 Reporting Considerations
2. Assessment Monitoring
3. Pre-Screen Testing
G. What is the states' role in the UCMR program?
IV. Cost of This Proposed Action
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
B. Paperwork Reduction Act
C. Regulatory Flexibility Act
D. Unfunded Mandates Reform Act
E. Executive Order 13132: Federalism
F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
H. Executive Order 13211: Actions that Significantly Affect
Energy Supply, Distribution, or Use
I. National Technology Transfer and Advancement Act
J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations
VI. Public Involvement in Regulation Development
VII. References
II. Statutory Authority and Background
A. What is the statutory authority for this action?
Section 1445(a)(2) of the Safe Drinking Water Act (SDWA), as
amended in 1996, requires that once every five years, beginning in
August 1999, the United States Environmental Protection Agency (EPA)
issue a new list of no more than 30 unregulated contaminants to be
monitored by public water systems (PWSs). It also requires that EPA
enter the monitoring data into the Agency's National Drinking Water
Contaminant Occurrence Database (NCOD). EPA's Unregulated Contaminant
Monitoring Regulation (UCMR) program must ensure that only a national
representative sample of PWSs serving 10,000 or fewer people would be
required to monitor. EPA must vary the frequency and schedule for
monitoring based on the number of persons served, the source of supply,
and the contaminants likely to be found.
B. How does EPA meet these statutory requirements?
Today's notice proposes 30 contaminants for monitoring during the
third five-year cycle, referred to as ``UCMR 3.'' These contaminants
include: 28 chemicals using six analytical methods and/or four
equivalent consensus organization-developed methods, and two viruses
using one analytical method. EPA has developed a proposed contaminant
list (Exhibit 1) and sampling design for UCMR 3 (2012-2016) with input
from both stakeholders and an EPA-State working group.
Exhibit 1--Proposed Contaminant Lists
------------------------------------------------------------------------
------------------------------------------------------------------------
List 1, Assessment Monitoring
------------------------------------------------------------------------
17-[beta]-estradiol chlorodifluoromethane (HCFC-22)
17-[alpha]-ethynylestradiol bromochloromethane (Halon 1011)
(ethinyl estradiol)
estriol 1,4-dioxane
equilin vanadium
estrone molybdenum
testosterone cobalt
4-androstene-3,17-dione strontium
1,2,3-trichloropropane chlorate
1,3-butadiene perfluorooctane sulfonic acid
(PFOS)
chloromethane (methyl chloride) perfluorooctanoic acid (PFOA)
1,1-dichloroethane perfluorononanoic acid (PFNA)
n-propylbenzene perfluorohexane sulfonic acid
(PFHxS)
bromomethane (methyl bromide) perfluoroheptanoic acid (PFHpA)
sec-butylbenzene perfluorobutanesulfonic acid (PFBS)
------------------------------------------------------------------------
List 3, Pre-Screen Testing
------------------------------------------------------------------------
enteroviruses noroviruses
------------------------------------------------------------------------
[[Page 11716]]
EPA published the first list for the Unregulated Contaminant
Monitoring Regulation cycle (i.e., UCMR 1) in the Federal Register on
September 17, 1999 (64 FR 50556), and the second list (i.e., UCMR 2) on
January 4, 2007 (72 FR 367). The monitoring lists that were applicable
under UCMR 1 and 2 are available at: https://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/.
In UCMR 1, EPA established a three-tiered approach for monitoring
contaminants based on the availability of analytical methods.
Assessment Monitoring for List 1 contaminants typically relies on
analytical methods that are in common use in drinking water
laboratories. Screening Survey monitoring for List 2 contaminants
relies on newly developed analytical methods that are not commonly used
in drinking water laboratories. Laboratory capacity to perform List 2
analyses is expected to be limited. Finally, UCMR 1 established the
option of Pre-Screen Testing for List 3 contaminants to address
contaminants with analytical methods that are in an early stage of
development. The expectation was that it would be used at a limited
number of systems determined to be most vulnerable to the targeted
contaminants.
For UCMR 2, EPA built on this established structure, and instituted
some changes to the rule design. These changes were based upon lessons
learned during UCMR 1. All large PWSs, serving more than 10,000 people,
and a nationally representative selection of 800 small PWSs serving
10,000 or fewer people monitored for List 1 contaminants. This
monitoring was conducted during a continuous 12-month period during the
January 2008 to December 2010 sampling time frame (quarterly for
surface water systems, and twice, at 6-month intervals, for ground
water systems). Systems subject to UCMR 2 included community water
systems (CWSs) and non-transient non-community water systems (NTNCWSs),
except those systems that purchase all of their finished water from
another PWS.
EPA designed the Assessment Monitoring sampling frame to ensure
that sample results would yield a high level of confidence and a low
margin of error. The design for a nationally representative sample of
small systems called for the sample to be stratified by water source
type (ground or surface water), service size category, and State (where
each State is allocated a minimum of two systems in its State
Monitoring Plan). With monitoring data from all large PWSs (a census of
all large systems) and a statistically representative sample of 800
small PWSs (for a total of over 4,000 systems), UCMR1 and UCMR 2
Assessment Monitoring provided sample data suitable to characterize
exposure, as would UCMR 3. Twenty eight chemicals are being proposed
for Assessment Monitoring under UCMR 3.
For the UCMR 2 Screening Survey, monitoring for List 2 contaminants
was conducted by approximately 400 PWSs serving more than 100,000
people (i.e., a census of all systems in this largest size category),
with a randomly selected sample of 320 PWSs serving between 10,001 and
100,000 people, and 480 small PWSs serving 10,000 or fewer people (EPA
included additional PWSs in the Screening Survey design under UCMR 2--
as compared to UCMR 1--to increase the statistical power of the
sample). During UCMR 2, Screening Survey systems were required to
monitor during a continuous 12-month period during the time frame of
January 2008 to December 2010 (quarterly for surface water systems, and
twice, at 6-month intervals, for ground water systems). With
approximately 1,200 systems participating in the Screening Survey,
sufficient data were generated to provide an overall national estimate
of population exposure. No List 2 Screening Survey monitoring is being
proposed under UCMR 3.
As under UCMR 1, no Pre-Screen Testing was conducted during the
UCMR 2. However, in UCMR 3, two viruses are proposed for Pre-Screen
monitoring.
EPA is proposing that UCMR 3 include: Assessment Monitoring for 28
chemicals; no Screening Survey; and, Pre-Screen Testing for two
viruses. Other proposed changes between UCMR 2 and UCMR 3 are
summarized in section III.A. ``What Are the Changes Being Proposed for
UCMR 3?'', and discussed in further detail throughout today's proposed
rule preamble.
C. How are the contaminant candidate list, the National Contaminant
Occurrence Database, and the UCMR interrelated?
The 1996 amendments to SDWA instituted the Contaminant Candidate
List (CCL) and UCMR programs to provide information EPA needs to
determine which drinking water contaminants have the greatest potential
to present a meaningful opportunity to reduce health risk through a
national primary drinking water regulation (NPDWR). The CCL is the
primary mechanism for the identification of contaminants that may
require regulation while UCMR provides EPA with the data necessary to
determine if a contaminant occurs at a frequency and concentration that
would be a public health concern. The CCL and UCMR are coordinated
parts of EPA's risk management process, and they support each other.
The UCMR sampling program is limited by statute to 30 contaminants at
one time, and was designed in consideration of the technical difficulty
and expense of analyzing up to 30 contaminants, as well as their
potential to occur in treated drinking water at levels of public health
concern. The data collected through the UCMR program are being stored
in the NCOD to: facilitate analysis and review of contaminant
occurrence; guide the conduct of the CCL process; and support the
Administrator's determination whether to regulate a contaminant in the
interest of protecting public health, as required under SDWA section
1412 (b)(1). Results of the UCMR 1 and 2 monitoring can be viewed by
the public at EPA's UCMR Web site: https://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/data.cfm.
III. Requirements of the Unregulated Contaminant Monitoring Program
A. What are the changes being proposed for UCMR 3?
EPA developed, and is proposing in today's action, a slightly
revised design for UCMR 3 based on experience with UCMR 1 and UCMR 2.
EPA reviewed various aspects of the UCMR 1 and 2 programs and
identified several critical changes that would improve implementation.
EPA's proposed approach and rationale for changes are described in the
following sections. Key aspects of the UCMR program that would remain
the same include direct implementation of the rule by EPA, the design
of Assessment Monitoring, and EPA funding for the small system testing.
In addition to requesting comment on the proposed list of contaminants,
EPA also requests comment on: Monitoring based on retail population;
revised data elements; and other changes between UCMR 2 and UCMR 3 that
are outlined in Exhibit 2. Updates to Web addresses, applicability
dates, corrections of minor typographical errors, and other minor
clerical edits are reflected in rule language, but do not appear in
Exhibit 2.
[[Page 11717]]
Exhibit 2--Notable Changes Being Proposed for UCMR 3
----------------------------------------------------------------------------------------------------------------
Rule section
----------------------------------------------------- Description of change Corresponding preamble
Number Title/description section
----------------------------------------------------------------------------------------------------------------
141.35(a) and 141.40(a)......... Population-based Base applicability on retail III.E.
applicability and population. Under UCMR 1 and 2,
related systems that purchased all of
applicability their water were not required to
date. monitor. These systems would now
be subject to UCMR monitoring
requirements. The new SDWIS/Fed
applicability date (i.e., the
date used to determine which
systems are subject to
monitoring) is also specified
141.35(c)(3)(ii)................ Demonstrating Clarifies that when identifying a III.F.
representative representative well, the well
ground water must be one of the higher annual
sampling volume producing and
locations. consistently active wells.
Should this location go off-
line, an alternative location
must be sampled.
141.35(c)(6)(ii) and Reporting schedule Reduces time for labs to III.F.
141.40(a)(5)(vi). electronically report results
(from 120 to 60 days); and for
systems to review, approve, and
report data (from 60 to 30 days).
141.35(c)(6) and 141.35(d)(2)... Reporting Requires small and large systems III.F.
monitoring to report all data elements in
results. Table 1 with each sample.
Previously, only a subset of the
data elements were to be
reported with each sample.
141.35(e)....................... Data elements..... Revises Table 1 of Sec. 141.35
to:
Add the zip code,
optional zip code extension,
and zip codes served to Data
Element 4--Sampling Point
Identification Code.
Clarify and update III.F. and V.J.
the definition of Data
Element 6--Disinfectant Type.
141.40(a)(1).................... Applicability to Removes exemption for transient III.E.
transient systems. systems, which would now be
subject to monitoring for List 3
contaminants if notified by EPA
or State.
141.40(a)(2)(ii)(C) and Pre-Screen Testing Systems participating in List 3 III.B. and III.F.
141.40(a)(3). viruses and monitoring would be required to
indicators. allow EPA to monitor for
enterovirus and norovirus and
collect specified pathogen
indicators.
141.40(a)(3).................... Analytes to be Revises Table 1 of this section III.B. and III.F.
monitored and to include:.
related New list of 28 priority
specifications. contaminants, with 6 EPA-
developed and 4 consensus
organization developed
analytical methods, as well as
new monitoring dates of January
2013 through December 2015.
141.40(a)(4)(i)(B).............. Sampling Specifies that schedules must be
requirements--fre adjusted based on sample point
quency. availability. Clarifies that
sampling points within a system
may have different schedules.
Also, revises Table 2 of this III.F.
section to include monitoring
requirements for microbiological
contaminants for ground water
systems at a frequency of two
times during a consecutive 12-
month period.
141.40(a)(4)(i)(C).............. Location.......... Requires systems conducting III.F.
Assessment Monitoring to collect
metal and chlorate samples at
distribution system maximum
residence time (DSMRT) sampling
locations. If these locations
are not defined, requires PWS to
collect samples at locations
that best represents the maximum
residence time in the
distribution system.
141.40(a)(5)(iii)............... Minimum Reporting Revises the definition of the MRL III.C.
Level (MRL)
definition.
----------------------------------------------------------------------------------------------------------------
B. What priority contaminants were selected for UCMR 3?
EPA used a stepwise prioritization process to identify potential
UCMR 3 contaminants. As a first step, the Agency reviewed the recently
promulgated CCL 3 list and the ``pre-CCL'' contaminants considered in
the development of CCL 3. Under the CCL 3 process, the Agency
considered the best available data and information on health effects
and occurrence to evaluate 7,500 unregulated contaminants. The final
CCL 3 is comprised of 104 chemicals or chemical groups and 12
microbiological contaminants that were selected through a data-driven
process that considered adverse health effects (potency and severity)
and occurrence (prevalence and magnitude). The list includes
pesticides, biological toxins, disinfection byproducts, chemicals used
in commerce, and waterborne pathogens (74 FR 51850, October 8, 2009
(USEPA, 2009c)). EPA used CCL 3, along with additional sources of
information about other emerging contaminants of potential concern, to
establish an initial list of approximately 150 potential UCMR 3
contaminants.
The proposed contaminant list for UCMR 3 was further pared down as
follows: (1) Contaminants with no currently available methods, or
methods that would not be ready in time for UCMR 3 monitoring were
eliminated; and, (2) those contaminants included in UCMR 1 or UCMR 2
monitoring were also eliminated from inclusion. This narrowed list of
fewer than 35 analytes was further considered by an EPA and State
working group, and prioritized using health effects data and other
critical endpoints, to arrive at a final proposed list of 30 analytes
listed in Exhibit 3. Further information on this
[[Page 11718]]
prioritization process, and on the health effects and occurrence data
EPA used to select the chemical analytes proposed for UCMR 3 are
contained in ``Possible Contaminants for Inclusion on UCMR 3--
Information Compendium'' (USEPA, 2010d).
EPA has not included hexavalent chromium (chromium-6) in the
proposed list of chemicals for UCMR 3 monitoring; however, EPA is aware
of potential concerns about chromium-6 occurrence in public water
supplies. EPA thus requests comment on whether the Agency should
include chromium-6 as one of the 30 contaminants for UCMR 3 Assessment
Monitoring. EPA has recently issued voluntary guidance to water systems
on monitoring for chromium-6, including recommendations regarding the
use of a modified version of EPA Method 218.6 for the analysis of
samples and a recommended reporting level of 0.06 ug/L (see https://water.epa.gov/drink/info/chromium/guidance.cfm). If EPA were to include
chromium-6 in UCMR 3, the Agency would incorporate it into Assessment
Monitoring. Under this approach, EPA would make chromium-6 monitoring
mandatory for all large water systems and a subset of small systems;
see also Section III.F.2 for further discussion of the Assessment
Monitoring approach. EPA requests comments on what contaminant(s)
should be removed from the list of 30 UCMR 3 contaminants if chromium-6
were added, as well as comments regarding the recommended and
alternative analytical method(s) and the appropriate reporting level.
EPA also requests comments on whether total chromium should also be
measured concurrent with chromium-6. Side-by-side measurements may
provide valuable information on relative occurrence and the utility of
total chromium monitoring as a surrogate for chromium-6.
EPA compiled background information for each of the 28 chemicals
being proposed for monitoring, including: Source and use; health
effects; production and release; occurrence in water; and persistence
and mobility (USEPA, 2010d). Health effects, occurrence in water,
transmission and treatment information were considered for the two
viruses. The primary source of this information is CCL 3 (74 FR 51850,
October 8, 2009 (USEPA, 2009c)). Where newer or additional information
was available and for those proposed UCMR 3 contaminants that were not
part of CCL 3, references are provided separately. In addition,
preliminary occurrence data are included that were collected as part of
EPA's second Six-Year Review of NPDWRs (75 FR 15500, March 29, 2010
(USEPA, 2010b)).
Exhibit 3--30 Proposed UCMR 3 Analytes
------------------------------------------------------------------------
------------------------------------------------------------------------
7 Hormones using EPA Method 539 (LC/MS/MS) \1\:
------------------------------------------------------------------------
17-[beta]-estradiol estrone
17-[alpha]-ethynylestradiol testosterone
(ethinyl estradiol)
estriol (16-[alpha]-hydroxy-17- 4-androstene-3,17-dione
[beta]-estradiol)
------------------------------------------------------------------------
equilin ...................................
------------------------------------------------------------------------
9 Volatile Organic Compounds (VOC) using EPA Method 524.3 (GC/MS) \2\:
------------------------------------------------------------------------
1,2,3-trichloropropane bromomethane (methyl bromide)
1,3-butadiene sec-butylbenzene
chloromethane (methyl chloride) chlorodifluoromethane (HCFC-22)
1,1-dichloroethane bromochloromethane (halon 1011)
n-propylbenzene ...................................
------------------------------------------------------------------------
Synthetic Organic Compound using EPA Method 522 (GC/MS) \3\:
------------------------------------------------------------------------
1,4-dioxane
------------------------------------------------------------------------
4 Metals using EPA Method 200.8 (IC/MS) \4\ or alternate SM \5\ or ASTM
Methods \6\:
------------------------------------------------------------------------
cobalt strontium
molybdenum vanadium
------------------------------------------------------------------------
Oxyhalide Anion using EPA Method 300.1 (IC/Conductivity) \7\ or
alternate SM \8\ or ASTM Methods \9\:
------------------------------------------------------------------------
chlorate
------------------------------------------------------------------------
6 Perfluorinated Chemicals using EPA Method 537 (LC/MS/MS) \10\:
------------------------------------------------------------------------
perfluorooctane sulfonate (PFOS) perfluorohexane sulfonic acid
(PFHxS)
perfluorooctanoic acid (PFOA) perfluoroheptanoic acid (PFHpA)
perfluorononanoic acid (PFNA) perfluorobutane sulfonic acid
(PFBS)
------------------------------------------------------------------------
2 Viruses (see Section III.B.7 for methods discussion): \11\
------------------------------------------------------------------------
enterovirus norovirus
------------------------------------------------------------------------
1. EPA Method 539 (LC/MS/MS) (USEPA, 2010c)
2. EPA Method 524.3 (GC/MS) (USEPA, 2009a)
3. EPA Method 522 (GC/MS) (USEPA, 2008)
4. EPA Method 200.8 (ICP/MS) (USEPA, 1994)
5. SM 3125 (SM, 1997)
6. ASTM D5673-10 (ASTM, 2010)
7. EPA Method 300.1 (IC/Conductivity) (USEPA, 1997)
8. SM 4110D (SM, 1997)
9. ASTM D6581-08 (ASTM, 2008)
[[Page 11719]]
10. EPA Method 537 (LC/MS/MS) (USEPA, 2009b)
11. Monitoring also includes sampling for pathogen indicators such as
total coliforms, E.coli, bacteriophage, Enterococci and aerobic
spores. EPA would pay for all sampling and analysis costs associated
with virus monitoring at these small systems.
1. Twenty-Eight Chemicals
EPA proposes monitoring for 28 chemicals in UCMR 3. Details of the
health effects and occurrence data EPA used to make these selections
are contained in ``Possible Contaminants for Inclusion on UCMR 3--
Information Compendium'' (USEPA, 2010d), available at Docket ID No. OW-
2009-0090.
2. Two Viruses
a. Enterovirus and Norovirus
EPA proposes to monitor for enterovirus and norovirus in UCMR 3.
Both enterovirus and norovirus (a group of viruses in the Caliciviruses
family) are listed on CCL3. They are proposed for UCMR 3 monitoring
because very limited data are available (Francy et al., 2004) on their
occurrence in undisinfected PWSs located in sensitive hydrogeological
areas. Of particular concern are PWSs in areas with karst or fractured
bedrock, as well as in non-community water systems. Recent data
indicate that undisinfected ground water systems with low total
coliform occurrence (and no Total Coliform Rule violations) had
significant viral presence and disease manifestation (Borchardt, 2008).
This draft study showed a statistically significant correlation between
viral qPCR (quantitative polymerase chain reaction) and self-reported
acute gastrointestinal illness. This indicates that qPCR can be used as
an indicator of relative vulnerability and potential disease incidence.
Borchardt's work showed a viral occurrence of 9% for enterovirus and 4%
for norovirus in CWSs, almost all of which were in aquifers not
considered sensitive. EPA proposes to perform this monitoring as a Pre-
Screen Testing of targeted undisinfected ground water systems located
in karst or fractured bedrock. The monitoring would include CWSs, as
well as non-transient and transient non-community water systems.
Monitoring would also include sampling for pathogen indicators such as
total coliforms, E.coli, bacteriophage, Enterococci and aerobic spores.
The objectives of this monitoring are to obtain information
concerning the occurrence of enterovirus and norovirus for further
evaluation, and to gain a better understanding of the co-occurrence of
pathogen indicators and viruses.
Enterovirus would be monitored using one method that has two
detection assays. The first is a tissue culture assay also used in the
Information Collection Rule survey conducted by EPA (USEPA, 1996), with
one change; the 1 MDS filter would be replaced with the
NanoCeram[supreg] filter, to significantly reduce sampling cost. The
NanoCeram[supreg] filter has proven to be as effective as 1 MDS filter
for the recovery of enteroviruses (Karim et al., 2009) and norovirus
(Gibbons et al., 2010). The second assay is the qPCR, which detects the
viral nucleic acid.
Norovirus would only be monitored using qPCR, as there is no tissue
culture method available. Both norovirus and enterovirus qPCR would be
performed as per the protocol in Lambertini et al. (2008). The qPCR
primers and probe for GI Norovirus would be as referenced in Jothikumar
et al. (2005), while GII Norovirus primers and probe would be as
referenced in Ando et al. (1995). Primers and probe referenced in De
Leon et al. (1990) and Monpoeho et al. (2000) would be used for
enterovirus qPCR.
A technical presentation describing Borchardt's work, and
supporting EPA's rationale for including these viruses in UCMR 3, is
available through the docket. EPA welcomes comments on the Borchardt
data and on the merits of the proposed UCMR 3 monitoring. EPA
anticipates that a peer-reviewed journal article describing the
Borchardt work will be published in advance of the publication of the
UCMR 3 final rule, and is committed to conducting appropriate peer
review of the UCMR 3 virus data before any final regulatory
determination by the Agency.
C. How were minimum reporting levels determined?
The quality of measurement definition is based on a standard tool
of analytical chemistry, percent recovery of a known amount of analyte
added to a reagent water sample (spiked blank). The lowest
concentration minimum reporting level (LCMRL) is defined as the lowest
spiking concentration at which recovery of between 50 and 150% is
expected 99% of the time by a single analyst.
The LCMRL is estimated using sophisticated statistical procedures
that have been incorporated into an LCMRL calculator tool that is
available on EPA's Web site (https://water.epa.gov/scitech/drinkingwater/labcert/analyticalmethods_ogwdw.cfm). The statistical
tool estimates a probability distribution for spike recovery as a
function of spiking concentration. This requires regression modeling
that estimates expected value and expected variance for repeated
measurements as functions of spiking concentration. Often this variance
is an increasing function of spiking level. In this case, ordinary
least squares regression is not appropriate to estimate the expected
value function. Weighted least squares is used with weights
proportional to the reciprocal of the expected variance, multiplied by
a weight (Tukey's biweight) that gives robustness against outliers. The
variance model is estimated using a Generalized Linear Model. To
estimate these regressions, an experimental design with replicate
spiking at multiple concentrations is required. If the LCMRL estimate
is below the lowest non-blank spiking concentration or above the
highest spiking concentration, another set of blanks must be spiked so
that the LCMRL is bracketed by the lowest and highest spike
concentrations when the LCMRL is re-estimated. The spiked
concentrations must be contained within the instrument calibration
curve that is routinely used for each analyte. The combined procedure
provides a robust estimator of the LCMRL and a sophisticated and useful
measure of method capability.
MRL
In today's action, EPA is proposing revisions to the definition of
the minimum reporting level (MRL). The proposed definition of the MRL
reflects improvements in the statistical procedures for determining the
LCMRL and MRL. These improvements were implemented by EPA to make the
models more robust, i.e., so that the models can accommodate a wider
range of observed LCMRL data sets. The MRL for an analyte measured by a
specified analytical method is designed to be an estimate of an LCMRL
that is achievable, with 95% confidence, by a capable analyst/
laboratory at least 75% of the time. Such a demonstration of ability to
reliably make quality measurements at the MRL is intended to achieve
high quality across the nation's laboratories.
In UCMR 2, the MRL was established by EPA by adding the mean of the
LCMRL determined according to the procedure detailed in ``Statistical
Protocol for the Determination of The Single-Laboratory Lowest
Concentration Minimum Reporting Level (LCMRL) and
[[Page 11720]]
Validation of the Minimum Reporting Level (MRL)'' (USEPA, 2004),
(https://www.epa.gov/ogwdw/methods/pdfs/methods/methods_lcmrl.pdf) by
the primary and secondary laboratories conducting the development and
validation of the analytical method to three times the difference of
the LCMRLs. If LCMRL data from three or more laboratories were
available, the MRL was established by EPA by adding three times the
standard deviation of the LCMRLs to the mean of the LCMRLs.
In UCMR 3, EPA estimated the MRL for an analyte/method by obtaining
data from several laboratories performing corresponding LCMRL studies.
These data are used to construct an approximation to the distribution
that would result from picking at random a laboratory/analyst
proficient in performing the analytical method, and having them perform
an LCMRL study and compute an LCMRL estimate. The strategy for
computing the MRL is two-fold. First, for each LCMRL data set, a
distribution for repeated LCMRL determinations by the same laboratory/
analyst is estimated by generating a large number of simulated values
using a Bayesian bootstrap approach. Second, these values are combined
to create an estimated overall distribution. If a result from one of
the laboratories is significantly higher than that of other
laboratories, this value would be down-weighted using a robust weight
function. The resulting weighted values are used to construct a
probability distribution from which the MRL is computed as the 95th
percentile. EPA requests comments regarding the proposed definition of
the MRL.
D. How would laboratories conduct UCMR analyses?
As proposed, all laboratories conducting analyses for UCMR 3 List 1
contaminants would need to receive EPA approval to perform those
analyses. Laboratories seeking approval would be required to provide
EPA with data that demonstrate their successful completion of an
initial demonstration of capability as outlined in each method,
verification of successful performance at the MRLs as specified in
today's action, and successful participation in an EPA Proficiency
testing (PT) program for the analytes of interest. On-site audits of
selected candidate laboratories may be conducted. Details of the EPA
laboratory approval program are contained in the technical manual
titled: ``UCMR 3 Laboratory Approval Requirements and Information
Document'' (USEPA, 2010e). This document will be available on the
electronic docket at: https://www.regulations.gov and will be provided
to laboratories that register for the laboratory approval program. In
addition, EPA may supply analytical reference standards of known
concentrations for selected analytes to participating/approved
laboratories, where such standards are not readily available through
commercial sources.
Laboratory Approval Process for UCMR 3
The proposed UCMR 3 laboratory approval program is the same as that
employed in previous UCMR cycles. It is designed to assess and confirm
the capability of laboratories to perform analyses using the methods
listed in Sec. 141.40(a)(3), Table 1, of today's proposed rule. The
UCMR 3 laboratory approval process is designed to assess whether
laboratories meet the required equipment, laboratory performance, and
data reporting criteria described in today's action. This evaluation
program is voluntary in that it only applies to laboratories intending
to analyze UCMR 3 samples. However, EPA would require systems to use
UCMR 3 approved laboratories when conducting monitoring for those
analytes listed in Table 1 of Sec. 141.40(a)(3) of this proposed rule.
A list of laboratories approved for UCMR 3 would be posted to EPA's
UCMR Web site: https://water.epa.gov/lawsregs/rulesregs/sdwa/ucmr/ucmr3/labs.cfm. Laboratories are encouraged to apply for UCMR 3 approvals as
early as possible, as schedules for large PWS sampling would be
completed soon after the final rule is promulgated. The steps for the
laboratory approval process are listed in the following paragraphs, a
through f.
a. Request to Participate.
To request participation in the UCMR 3 laboratory approval process,
the laboratory must contact EPA. Laboratories must send this request
to: UCMR 3 Laboratory Approval Coordinator, USEPA, Technical Support
Center, 26 West Martin Luther King Drive (MS 140), Cincinnati, OH
45268; or e-mail at: UCMR_Sampling_Coordinator@epa.gov. EPA plans to
begin accepting requests for registration forms for the List 1
(Assessment Monitoring) methods beginning March 3, 2011. EPA
anticipates that the final opportunity for a laboratory to request the
necessary registration forms would be 90 days after final rule
publication, though laboratories are encouraged to apply as early as is
practical after the publication of today's proposed rule.
b. Registration.
Each laboratory that wishes to participate in UCMR 3 monitoring
would be required to complete a registration form. EPA expects this
registration information to include: Laboratory name; mailing address;
shipping address; contact name; phone number; fax number; e-mail
address; and a list of the UCMR 3 methods for which the laboratory is
seeking approval. The purpose of the registration step is to provide
EPA with the necessary contact information, and ensure that each
laboratory receives a customized application package of materials and
instructions for the methods that it plans to use.
c. Application Package.
When EPA receives the registration information, a customized
application package would be sent to the laboratory for completion.
Information requested in the application would include the following:
Initial demonstration of capability data, including precision,
accuracy, and results of MRL studies, information regarding analytical
equipment, proof of current drinking water laboratory certification,
and example chromatograms for each method under review.
The laboratory would be required to confirm that it will post UCMR
3 monitoring results (on behalf of its PWS clients) to EPA's UCMR
electronic data reporting system.
d. EPA Review of Application Package.
EPA would review the application package and, if necessary, request
follow-up information. Satisfactory completion of this portion of the
process would be required for the laboratory to participate in the UCMR
3 Proficiency Testing (PT) program.
e. Proficiency Testing.
A PT sample is a synthetic sample containing a concentration of an
analyte that is known to EPA, but unknown to the laboratory being
tested. To complete the initial laboratory approval process, a
laboratory would be expected to meet specific acceptance criteria for
the analysis of a UCMR 3 PT sample(s) for each method for which the
laboratory is seeking approval. EPA intends to offer up to four
opportunities for a laboratory to successfully analyze the UCMR 3 PT
samples. Up to three of these studies would be conducted prior to the
publication of the final rule, but at least one study would be
conducted after publication of the final rule. This would allow
laboratories to complete their portion of the laboratory approval
process prior to publication of the final rule, and therefore, receive
their approval, immediately following the publication of the final
rule, or to wait until the final rule is published before completing
the required laboratory approval analyses. A laboratory only
[[Page 11721]]
needs to pass one of the PT studies for each analytical method for
which they are requesting approval. Laboratories applying for UCMR 3
approval, and laboratories conducting UCMR 3 analyses, may be subject
to on-site laboratory audits. No PT studies would be conducted after
the start of monitoring; however, laboratory audits would be ongoing
throughout the entire monitoring period of 2013-2015. Initial
laboratory approval would be contingent upon successful completion of a
PT study. Continued laboratory approval is contingent upon successful
completion of audits.
f. Written EPA Approval.
After steps ``a'' through ``e'' of the PT approval process have
been successfully completed, EPA would send the laboratory a letter
listing the methods for which approval is pending (if the PT study and
laboratory evaluation is conducted prior to promulgation of the final
rule) or approval is granted (after promulgation of the final rule).
Laboratories receiving a pending approval may then be approved without
further action, following promulgation of the final rule, or they may
need to take additional action, contingent upon what changes are
applied to the rule between this proposal and promulgation of the final
rule.
E. What are the new applicability considerations?
In section 141.40(a) of today's proposed rule changes, EPA is
proposing a new applicability date for information in the SDWIS/Fed
system inventory. As proposed, the determination of whether a PWS is
required to monitor under UCMR 3 would be based on the type of system
(e.g., community water system, non-transient non-community water
system, etc.), and its retail population served, as indicated by SDWIS/
Fed on December 31, 2010.
In addition, EPA is proposing two changes to the applicability of
UCMR 3 to PWSs. First, EPA proposes that applicability be based on
retail population served. Whereas under UCMR 1 and 2 systems that
purchased all of their water were not required to monitor; these
systems would now be subject to UCMR monitoring requirements. Second,
under UCMR 1 and 2, transient systems were exempt from monitoring.
EPA's proposed changes would include transient systems in the universe
from which EPA may select small PWSs for List 3 monitoring. Such
systems would only be included in UCMR 3 List 3 monitoring if they are
notified by EPA that they have been selected, and this monitoring would
be done by EPA or its contractor. All other applicability criteria for
UCMR 3 remain the same as those under UCMR 2.
1. Applicability Based on Population Served
Under UCMR 1, large PWSs were defined as those systems that served
a population of more than 10,000 people and small PWSs were those that
served 10,000 or fewer people. While this included the sum of the
population served by the combined distribution system, this requirement
was occasionally misunderstood. For UCMR 2, EPA clarified the
population definition to include the sum of the retail population
served directly by the PWS plus the population served by any
consecutive system(s), receiving all or part of its finished water from
that PWS. As established in the Stage 2 Disinfectants and Disinfection
Byproducts Rule (68 FR 49548, August 18, 2003 (USEPA, 2003)), EPA
defines a ``consecutive system'' as a PWS that buys or otherwise
receives some or all of its finished water from one or more wholesale
system(s). Under the population definition of UCMR 2, systems that
purchased all of their water from other systems were not required to
monitor. EPA is proposing a change in the definition of system
population to include only a system's retail population. UCMR 3
requirements for systems would be based on their retail population
served as reported to SDWIS/Fed as ``Population Served'' (i.e.,
wholesale or consecutive populations are not included).
EPA is proposing that PWSs be required to monitor for UCMR 3
contaminants, regardless of whether they purchase any or all of their
water from another system. The population definitions used for the
previous UCMRs created an inconsistency for PWSs purchasing their
water. If a PWS purchased all of their water, they were not required to
monitor at all, and systems that had no retail connections did have to
monitor. If a PWS purchased some of their water, they were required to
monitor from their own sources as well as their purchased source. The
new proposed definition would eliminate this inconsistency. It would
also eliminate the requirements for systems with no retail connections
to monitor. EPA is aware that PWSs that purchase water evaluate their
supply needs and associated costs, and may make adjustments during the
UCMR monitoring period. They have been known to change wholesale
suppliers or switch sources that they can directly access and treat for
their retail customers. The dynamic nature of wholesale water supply is
prompting EPA to propose and solicit stakeholder comment on
establishing retail population as a clearer measure for determining
applicability of the UCMR 3 requirements. Retail population is a
consistent factor for applicability determination and evaluating the
direct sources (all entry points including wholesale connections) would
improve data quality by directly assessing the drinking water served to
the respective retail population. It is also difficult to accurately
determine the total population served by each source of water. For
example, if PWS ``A'' buys all of its water from three different PWSs
(``B, C, D''), it is unclear how to divide PWS A's retail population
among the three PWSs to determine the wholesale populations for systems
B, C, and D. Under the previous UCMR specifications, the total
population of all systems was added together, which could lead to
overestimating the population served by each source of water.
Moreover, a system's population is used to determine exposure
estimates. Because the retail population comprises all of the people
exposed to water from a particular system, EPA would have a clearer
understanding of the number of people exposed to a detected
contaminant. The proposed change to the definition of population would
allow EPA to better estimate the total population served by a water
system and ensures that exposure calculations are more accurate.
PWSs are required to report their retail population to the Safe
Drinking Water Information System-Federal (SDWIS/Fed), so this
population is readily accessible to EPA when determining which systems
are required to monitor for the UCMR 3. Using a system's retail
population would also make the list of PWSs subject to UCMR more stable
over the UCMR 3 monitoring period, and eliminate another inconsistency
in previous UCMRs. In past UCMRs, if a PWS began purchasing all of
their water after the applicability date, the PWS would still have to
monitor under UCMR. If, however, a system began using its own water
sources after the UCMR applicability date, the system would not be
required to begin monitoring under UCMR. Using a system's retail
population to determine whether a system is subject to UCMR
requirements would eliminate this disparity.
Note that systems that purchase water with multiple connections
from the same wholesaler would be permitted to propose one
representative connection
[[Page 11722]]
from that wholesaler. PWSs would choose a sampling location from among
the higher annual volume EPTDS connections. If the connection selected
as the representative EPTDS was not available for sampling, an
alternate representative connection would need to be sampled.
2. Applicability for Transient Systems
Under UCMR 1 and 2, Section 141.40(a)(1), transient non-community
water systems were specifically exempted from UCMR monitoring. EPA is
proposing revisions that would allow for certain transient systems to
be selected for Pre-Screen Testing for List 3 contaminants. Under UCMR
3, EPA is proposing to conduct Pre-Screen Testing for enterovirus and
norovirus and related pathogen indicators at targeted undisinfected
ground water systems that serve 1,000 or fewer customers. EPA is
proposing to include transient systems among the possible targeted
systems--and to focus on viruses and not chemicals at those systems--
since viruses are acute pathogens and exposure through a one-time
ingestion (e.g., at a transient system) is of potential health concern.
EPA requests comments regarding the inclusion of transient systems in
UCMR 3 Pre-Screen Testing.
As proposed under 141.40(a)(1) and 141.40(a)(2)(ii)(C), if any
system (including transient systems) is notified by EPA or their state
that they have been selected for Pre-Screen Testing the system must
permit EPA (at EPA's expense) to sample and analyze for List 3
contaminants, and pathogen indicators, such as total coliform, E. coli,
bacteriophage, Enterococci, and aerobic spores.
F. UCMR