Unregulated Contaminant Monitoring Regulation (UCMR) for Public Water Systems Revisions, 368-398 [E6-22123]
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Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
40 CFR Parts 9, 141 and 142
[Docket No. OW–2004–0001; FRL–8261–7]
RIN 2040–AD93
Unregulated Contaminant Monitoring
Regulation (UCMR) for Public Water
Systems Revisions
AGENCY:
This final rule is effective on
February 5, 2007. For purposes of
judicial review, this rule is promulgated
as of 1 p.m. eastern time on January 4,
2007 as provided in 40 CFR 23.7. The
incorporation by reference of certain
publications listed in this rule is
approved by the Director of the Federal
Register as of February 5, 2007.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. OW–2004–0001. All documents in
the docket are listed in the index at
www.regulations.gov. Although listed
in the index, some information is not
publicly available, e.g., confidential
business information or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically at https://
www.regulations.gov or in hard copy at
the Water Docket, EPA/DC, EPA West,
Room 3334, 1301 Constitution Ave.,
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 this Public Reading Room is
(202) 566–1744, and the telephone
number for 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; e-mail
address munch.dave@epa.gov. For
general information, contact the Safe
Drinking Water Hotline. Callers within
DATES:
ENVIRONMENTAL PROTECTION
AGENCY
Environmental Protection
Agency.
Final rule.
ACTION:
SUMMARY: The Safe Drinking Water Act
(SDWA), as amended in 1996, requires
the United States Environmental
Protection Agency (EPA) to establish
criteria for a program to monitor
unregulated contaminants and to
publish a list of contaminants to be
monitored every five years. EPA
published the first set of contaminants
in 1999. This final regulation meets the
SDWA requirement by publishing the
next set of unregulated contaminants to
be monitored and the requirements for
such monitoring.
This final rule describes the design for
the second Unregulated Contaminant
Monitoring Regulation (UCMR) cycle
(i.e., UCMR 2) of 2007–2011. EPA is
requiring monitoring of 25 chemicals
using 5 different analytical methods.
UCMR 2 monitoring will occur during
2008–2010. Implementation of this final
rule will benefit the environment by
providing EPA and other interested
parties with scientifically valid data on
the occurrence of these contaminants in
drinking water, thereby permitting the
assessment of the population potentially
being exposed and the levels of that
exposure. These data are the primary
source of occurrence and exposure data
for the Agency to determine whether to
regulate these contaminants.
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.
SUPPLEMENTARY INFORMATION:
I. General Information
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 will be required to
monitor. A community water system
means a PWS which serves at least 15
service connections used by year-round
residents or regularly serves at least 25
year-round residents. Non-transient
non-community water system means a
PWS that is not a community water
system and that regularly serves at least
25 of the same people over 6 months per
year. Only a nationally representative
sample of community and non-transient
non-community systems serving 10,000
or fewer people will be required to
monitor. Transient non-community
systems (i.e., systems that do not
regularly serve at least 25 of the same
people over 6 months per year) will not
be required to monitor. States,
Territories, and Tribes that qualify for
treatment as a State for purposes of this
program, may participate in the
implementation of the second cycle of
the Unregulated Contaminant
Monitoring Regulation (i.e., UCMR 2)
through a Partnership Agreement. These
agencies may choose to conduct
analyses to measure for contaminants in
water samples collected for the UCMR
2, in which case they will be regulated
by this action.
Regulated categories and entities are
identified in the following table.
Category
Examples of potentially regulated entities
State, local, & tribal Governments ................................................
States, local and tribal governments that analyze water samples on behalf of PWSs required to conduct such analysis;
States, local and tribal governments that directly operate
community 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.
Industry ..........................................................................................
Municipalities .................................................................................
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a NAICS
NAICSa
924110
221310
924110
= North American Industry Classification System.
This table is not intended to be
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 could potentially be regulated by
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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
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of Federal Regulations, and applicability
criteria in § 141.40(a)(1) and (2) of this
final action. If you have questions
regarding the applicability of this action
to a particular entity, consult the person
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listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
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Abbreviations and Acronyms
HBB 2,2’,4,4’,5,5’-hexabromobiphenyl
µg/L Microgram per liter
ASDWA Association of State Drinking
Water Administrators
BDE–47 2,2’,4,4’-tetrabromodiphenyl
ether
BDE–99 2,2’,4,4’,5pentabromodiphenyl ether
BDE–100 2,2’,4,4’,6pentabromodiphenyl ether
BDE–153 2,2’,4,4’,5,5’hexabromodiphenyl ether
CCL Contaminant Candidate List
CFR Code of Federal Regulations
DBP Disinfection Byproduct
DBPR Stage 1 or Stage 2 Disinfectants
and Disinfection Byproducts Rule
DSMRT Distribution system maximum
residence time
DQO Data quality objective
DWSRF Drinking Water State
Revolving Fund
EPA United States Environmental
Protection Agency
EPTDS Entry point to the distribution
system
ESA Ethane sulfonic acid
FR Federal Register
GC Gas chromatography
GWUDI Ground water under the direct
influence of surface water
HAA5 Haloacetic acid 5 (5 HAAs
currently regulated)
HPLC High performance liquid
chromatography
HRPIR Half range prediction interval of
results
ICR Information collection request
IDC Initial demonstration of capability
IDSE Initial distribution system
evaluation
IHS Indian Health Service
LC Liquid chromatography
LCMRL Lowest concentration
minimum reporting level
LFSM Laboratory fortified sample
matrix
LFSMD Laboratory fortified sample
matrix duplicate
MCL Maximum contaminant level
MRL Minimum reporting level
MS Mass spectrometry
NAICS National American Industry
Classification System
NCOD National Drinking Water
Contaminant Occurrence Database
NDBA N-nitroso-di-n-butylamine
NDEA N-nitrosodiethylamine
NDMA N-nitrosodimethylamine
NDPA N-nitroso-di-n-propylamine
NMEA N-nitrosomethylethylamine
NPDWR National Primary Drinking
Water Regulation
NPYR N-nitrosopyrrolidine
NTTAA National Technology Transfer
and Advancement Act
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OA Oxanilic acid
OMB Office of Management and
Budget
PA Partnership agreement
PIR Prediction interval of results
PT Proficiency testing
PWS Public water system
PWSID Public water system
identification
QA Quality assurance
QC Quality control
RDX Hexahydro-1,3,5-trinitro-1,3,5triazine
RFA Regulatory Flexibility Act
RSD Relative standard deviation
SBA Small Business Administration
SDWA Safe Drinking Water Act
SDWARS Safe Drinking Water
Accession and Review System
SDWIS Safe Drinking Water
Information System
SPE Solid phase extraction
TNT 2,4,6-trinitrotoluene
TTHM Total trihalomethanes
UCMR Unregulated Contaminant
Monitoring Regulation
UMRA Unfunded Mandates Reform
Act of 1995
USEPA United States Environmental
Protection Agency
Table of Contents
I. General Information
Does This Action Apply to Me?
II. Statutory Authority and Background
A. What Is the Statutory Authority for
UCMR?
B. How Does EPA Meet These Statutory
Requirements?
III. Summary of This Rule
A. What Are the Major Changes between
the Proposed and Final Rule?
Exhibit 1: Changes to UCMR 2 between
Proposed and Final Rule
B. Which Water Systems Must Monitor?
1. This Rule
2. Summary of Major Comments
C. What Are the UCMR 2 Priority
Contaminants and Associated Methods?
1. List Compilation
Exhibit 2: Analytical Methods Approved
for UCMR 2 Monitoring
2. Acetanilide Pesticides, Degradation
Products, and Related Methods
3. Explosives and Related Methods
4. Perchlorate and Related Methods
5. Nitrosamines/NDMA and Related
Methods
6. Flame Retardants, Other Priority
Contaminants, and Related Methods
7. Triazines Chlorodegradates and Parent
Compounds
8. Other Compounds That Were
Considered
D. How Are Laboratories Approved for
UCMR 2 Monitoring?
1. This Rule
2. Summary of Major Comments
E. What Is A System’s Responsibility
Regarding the Use of Laboratories?
1. This Rule
2. Summary of Major Comments
F. What Specific Quality Control
Requirements Must Be Followed?
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1. Method Development Approach and
Method Defined Quality Control
2. Minimum Reporting Level
3. Lowest Concentration Minimum
Reporting Level
4. Laboratory Fortified Sample Matrix and
Laboratory Fortified Sample Matrix
Duplicate
G. When Are Samples Collected?
1. This Rule
2. Summary of Major Comments
H. Where Are Samples Collected?
1. Entry Points to the Distribution System
2. Distribution System Maximum
Residence Time
I. How Should Samples Be Collected?
1. This Rule
2. Summary of Major Comments
J. What Are the UCMR 2 Reporting
Requirements?
1. Information Required Prior to
Monitoring
2. Reporting of Required Data Elements
3. Reporting Process
4. Cross-Media Reporting and Data
Availability
K. What Constitutes a Violation Under
UCMR 2?
L. Technical Correction Rule Changes in
This Rule
1. Changes Pertaining to Aldicarb
Monitoring
2. Changes Pertaining to State Primacy
IV. State and Tribal Participation
A. Partnership Agreements
1. This Rule
2. Summary of Major Comments
B. Governors’ Petition and State-Wide
Waivers
V. Cost and Benefits of This Rule
VI. 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
K. Congressional Review Act
VII. Public Involvement in Regulation
Development
VIII. References
List of Exhibits
Exhibit 1: Changes to UCMR 2 between
Proposed and Final Rule
Exhibit 2: Analytical Methods Approved for
UCMR 2 Monitoring
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II. Statutory Authority and Background
A. What Is the Statutory Authority for
UCMR?
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) shall issue a
list of no more than 30 unregulated
contaminants to be monitored by public
water systems (PWSs), and that EPA
enter the monitoring data into the
National Drinking Water Contaminant
Occurrence Database (NCOD). EPA’s
UCMR program must ensure that only a
nationally representative sample of
PWSs serving 10,000 or fewer people
will be required to monitor; however,
there are no such restrictions on the
number of systems serving more than
10,000 people. EPA must vary the
frequency and schedule for monitoring
based on the number of people a system
serves, the source of supply, and the
contaminants likely to be found.
B. How Does EPA Meet These Statutory
Requirements?
To fulfill the initial SDWA
requirements, EPA published
‘‘Revisions to the Unregulated
Contaminant Monitoring Regulation for
Public Water Systems; Final Rule,’’ on
September 17, 1999 (64 FR 50556,
(USEPA, 1999)). Several supplemental
rules were published to establish
analytical methods and to provide
clarifications and refinements to the
initial rule: 65 FR 11372, March 2, 2000
(USEPA, 2000); 66 FR 2273, January 11,
2001 (USEPA, 2001a); and 67 FR 65888,
October 29, 2002 (USEPA, 2002b).
SDWA, as amended in 1996, requires
that at least once every five years EPA
identify a list of no more than 30
unregulated contaminants to be
monitored. This final action fulfills this
statutory obligation, identifying 25
priority contaminants for monitoring
using five analytical methods. EPA has
developed a contaminant list (Exhibit 2,
in Section III.C.1) and sampling design
for UCMR 2 (2007–2011) with input
from both stakeholders and an EPA
working group. This list is the same as
was presented in the proposed rule,
with one exception: perchlorate has
been removed from the UCMR 2
monitoring requirements (see Section
III.C. 4 for further discussion).
III. Summary of This Rule
A. What Are the Major Changes Between
the Proposed and Final Rule?
EPA published ‘‘Revisions to the
Unregulated Contaminant Monitoring
Regulation for Public Water Systems;
Proposed Rule,’’ on August 22, 2005 (70
FR 49094, (USEPA, 2005a)). EPA
received comments from 36 public
commenters.
In response to comments received and
further consideration, EPA removed
perchlorate from the list of
contaminants to be monitored for under
UCMR 2, and revised or clarified
requirements pertaining to system
applicability criteria, reporting,
monitoring, and quality control. In
addition, to accommodate PWS
preparation for rule implementation and
to provide additional assurance of
sufficient laboratory capacity, this rule
contains revised language that changes
the start of monitoring from July 2007 to
January 2008, such that the effective
monitoring period is now January 2008
through December 2010. Exhibit 1
provides a summary of these changes,
and a listing of the corresponding
preamble section, which provides a
more detailed discussion of the
revisions and related public comments.
Sections III.B–K summarize the different
aspects of this rule and the associated
major comments received in response to
the August 2005 proposed rule and their
impact, if any, on this rule.
This summary focuses on the changes
between the proposed and final rule,
and requirements with deadlines that
are triggered by the publication date of
this final rule. EPA has compiled a
document containing all public
comments and EPA’s responses entitled
‘‘UCMR 2 Categorized Public
Comments,’’ which can be obtained by
going to https://www.regulations.gov,
and searching for Docket ID No. OW–
2004–0001 under the advanced search
tab.
EXHIBIT 1.—CHANGES TO UCMR 2 BETWEEN PROPOSED AND FINAL RULE
Rule section
Description of change
Title/description
141.35(a) ........................................
General applicability .....................
141.35(c)(3)(i) ................................
Documenting ground water representative sampling locations.
141.35(c)(5) ...................................
PWS notification of EPA if sampling schedule cannot be met.
141.35(e) ........................................
Data Elements ..............................
141.40(a)(3) ...................................
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Number
Analytes to be monitored and
monitoring period.
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Defines ‘‘finished water’’ to clarify the definition of
‘‘population served’’.
Clarifies that approved representative well plans
from previous UCMR cycles can be submitted to
identify representative entry point(s).
Provides exception to notification requirement for
PWS with ground water sampling location that
can collect second sample sets within 5–7
months of the first sample set.
Revises Table 1 of § 141.35 to:
1. Clarify the definition of ‘‘Water Source Type’’ for
a sampling point.
2. Change the name of ‘‘Sampling Point Type Identification Code’’ to ‘‘Sampling Point Type Code’’
and distinguish this data element from ‘‘Sampling
Point Identification Code’’.
3. Clarify the definition for ‘‘Disinfectant Residual
Type’’.
Revises Table 1 of 141.40 to:
1. Change monitoring begin date to January 2008,
and Screening Survey monitoring period to coincide with Assessment Monitoring.
2. Delete perchlorate from table and associated
footnotes.
3. Revise minimum reporting levels to one significant figure.
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Corresponding
preamble section
III.B.
III.J.1.c.
III.J.1.d.
III.J.2.
III.G.
III.C.4.
III.F.2.
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EXHIBIT 1.—CHANGES TO UCMR 2 BETWEEN PROPOSED AND FINAL RULE—Continued
Rule section
Description of change
Number
Title/description
141.40(a)(4)(i)(A) ...........................
Monitoring schedules ....................
141.40(a)(4)(i)(B) ...........................
Frequency .....................................
141.40(a)(4)(i)(D) ...........................
Sampling Instructions ...................
141.40(a)(4)(i)(G) ...........................
141.40(a)(5)(i) ................................
Laboratory errors or sampling deviations.
Sample collection preservation ....
141.40(a)(5)(iii)(B)(2) .....................
Quality control requirements ........
141.40(a)(5)(iv) ..............................
Laboratory accuracy and precision.
141.40(a)(5)(v) ...............................
Detection confirmation for perchlorate.
B. Which Water Systems Must Monitor?
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1. This Rule
This rule requires that Assessment
Monitoring be conducted by all large
community and non-transient, noncommunity water systems serving more
than 10,000 people, and a nationally
representative sample of 800 small
water systems serving 10,000 or fewer
people. Transient non-community water
systems and those systems that
purchase all of their finished water from
another system are excluded from the
requirements of UCMR 2. Assessment
Monitoring is the largest in scope of the
three UCMR 2 monitoring components
(or tiers). Under Assessment
Monitoring, ‘‘List 1’’ contaminants, for
which standard analytical methods are
available, are monitored to assess
national occurrence in drinking water.
These are the priority contaminants for
which analytical method technologies
are well established.
The second tier of UCMR 2 is referred
to as ‘‘List 2’’ or Screening Survey
monitoring. List 2 contaminants are
those for which analytical methods have
been recently developed, and for which
the technologies are not widely used;
laboratory capacity, therefore, may be
insufficient to conduct the larger scale
Assessment Monitoring. The Screening
Survey will be conducted by
approximately 400 PWSs serving more
than 100,000 people (all systems in this
largest size category), by a randomly
selected sample of 320 PWSs serving
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Clarifies that EPA or the State will determine PWS
monitoring schedules.
1. Requires PWSs with ground water sampling locations that cannot collect their second samples
within 5–7 months of the first samples to contact
EPA.
2. Changes Table 2 to indicate that ground water
sample events must occur 5–7 months apart.
1. Clarifies that acetanilide parent and degradates
must be sampled at the same time and location.
2. Deletes reference to collection methods for perchlorate samples
Changes resampling deadline from within 14 days
to within 30 days.
Deletes reference to preservation methods for perchlorate samples.
Deletes additional quality control requirements for
perchlorate methods.
Changes method requirement to fortify the matrix
at the minimum reporting level (MRL) concentration to within ;+/¥50% vs. +/¥20%.
Deletes requirements in this section; and renumbers subsequent paragraphs accordingly.
between 10,001 and 100,000 people,
and by 480 small PWSs.
Pre-Screen Testing, the third tier of
UCMR monitoring that is designed for
priority ‘‘List 3’’ contaminants, whose
methods are very new or specialized, is
not required in this action, although
EPA is retaining the regulatory language
that supports Pre-Screen Testing
authority as part of the three-tiered
UCMR framework. If EPA ultimately
decides to include Pre-Screen Testing as
part of this or a future UCMR, EPA will
initiate a rulemaking action to propose
List 3 contaminants (and their
associated analytical methods) and to
solicit public comments.
This rule also defines ‘‘population
served’’ as ‘‘the number of people
served directly by the PWS’’ plus those
served ‘‘by any consecutive system
receiving all or part of its finished water
from that PWS.’’ To help clarify the
definition of population served, the
final regulation will also include the
definition of ‘‘finished water’’ that was
recently finalized as part of the ‘‘Stage
2 Disinfectants and Disinfection
Byproducts Rule’’ (71 FR 388, January 4,
2006 (USEPA, 2006a)) as follows:
‘‘Finished water is water that is
introduced into the distribution system
of a public water system and is intended
for distribution and consumption
without further treatment, except the
treatment necessary to maintain water
quality in the distribution system (e.g.,
booster disinfection, addition of
corrosion control chemicals).’’ This final
regulation also specifies the PWS
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Corresponding
preamble section
III.G. and
III.J.1.d.
III.G.
III.C.2; III.F.1;
and III.C.4.
III. I.
III.C.4.
III.C.4.
III.F.4.
III.C.4 and
III.F.1.
system’s water source and population
served, as of June 30, 2005, as the basis
for establishing a defined list of PWSs
that are subject to the rule requirements.
2. Summary of Major Comments
Comments included a
recommendation for EPA to define the
term ‘‘finished water’’ in EPA’s
definition of ‘‘population served,’’ and
support for the designation of the June
30, 2005, applicability date because it
would eliminate some of the confusion
that occurred under UCMR 1 and avoid
extra effort to keep monitoring plans
accurate and current. In response to
these comments, this final regulation
contains the definition of ‘‘finished
water’’ that was recently finalized as
part of the Stage 2 Disinfection
Byproducts Rule and retains the
proposed applicability date. EPA agrees
that the specific applicability date of
June 30, 2005, will help to streamline
the implementation process.
Other comments included
recommendations to publish the list of
systems that are subject to UCMR 2.
Such a list, including preliminary
schedules, is posted on the UCMR Web
page: https://www.epa.gov/safewater/
ucmr/ucmr2.
C. What Are the UCMR 2 Priority
Contaminants and Associated Methods?
1. List Compilation
a. This Rule
This rule specifies 25 contaminants
for monitoring, along with five EPA
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Methods for analysis as listed in Exhibit
2. EPA began with a list of over 200
contaminants, compiled from a variety
of different sources, including: UCMR 1
reserved contaminants; Candidate
Contaminant List 1 (CCL 1) ‘‘deferred
pesticides’’; CCL 1 suspected endocrine
disruptors; and other emerging
contaminants. The CCL is a list of
contaminants that are not subject to any
proposed or promulgated National
Primary Drinking Water Regulation
(NPDWR), are known or anticipated to
occur at PWSs, and may require
regulation under SDWA. The first CCL,
published in March 1998 (referred to as
‘‘CCL 1’’), identified 60 contaminants or
contaminant groups (63 FR 10274,
March 2, 1998 (USEPA, 1998b)) that
were divided into categories to
represent research and data needs for
each of the following: (1) Regulatory
determination priorities; (2) health
effects research priorities; (3) treatment
research priorities; (4) analytical
methods research priorities; and (5)
occurrence priorities. Through a multistepped review and prioritization
process (with relative health effects the
top priority), the UCMR analyte list was
narrowed and prioritized, as described
in the August 2005 proposed rule, and
26 contaminants were identified.
However, based on public comment and
further consideration, EPA has removed
the requirement for monitoring
perchlorate under the UCMR 2 program
(see Section III.C.4).
EXHIBIT 2.—ANALYTICAL METHODS APPROVED FOR UCMR 2 MONITORING
Analytical method 1
Contaminant
EPA Method 527 (SPE/GC/MS) .......................................
2,2′,4,4′-tetrabromodiphenyl ether (BDE–47) .................
EPA Method 529 (SPE/GC/MS) .......................................
2,2′,4,4′,5-pentabromodiphenyl ether (BDE–99).
2,2′,4,4′,5,5′-hexabromobiphenyl (HBB).
2,2′,4,4′,5,5′-hexabromodiphenyl ether (BDE–153).
2,2′,4,4′,6-pentabromodiphenyl ether (BDE–100).
Dimethoate.
Terbufos sulfone.
1,3-dinitrobenzene ...........................................................
EPA Method 521 (SPE/GC/CI/MS/MS) ............................
2,4,6-trinitrotoluene (TNT).
Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX).
N-nitrosodiethylamine (NDEA) ........................................
EPA Method 535 (SPE/LC/MS/MS) .................................
N-nitrosodimethylamine (NDMA).
N-nitroso-di-n-butylamine (NDBA).
N-nitroso-di-n-propylamine (NDPA).
N-nitrosomethylethylamine (NMEA).
N-nitrosopyrrolidine (NPYR).
Acetochlor ethane sulfonic acid (ESA) ...........................
EPA Method 525.2 (SPE/GC/MS) ....................................
Acetochlor oxanilic acid (OA).
Alachlor ESA.
Alachlor OA.
Metolachlor ESA.
Metolachlor OA.
Acetochlor .......................................................................
UCMR 2 ‘‘List’’
List 1, Assessment Monitoring: 7 contaminants.
List 1, Assessment Monitoring: 3 contaminants.
List 2, Screening Survey: 6
contaminants.
List 2, Screening Survey: 6
contaminants.
List 2, Screening Survey: 3
contaminants.
Alachlor.
Metolachlor.
Total of 25 UCMR 2 contaminants.
1 EPA Method 521: Determination of Nitrosamines in Drinking Water by Solid Phase Extraction and Capillary Column Gas Chromatography
with Large Volume Injection and Chemical Ionization Tandem Mass Spectrometry (MS/MS) (USEPA, 2004a).
EPA Method 525.2: Determination of Organic Compounds in Drinking Water by Liquid-Solid Extraction and Capillary Column Gas Chromatography/Mass Spectrometry (USEPA, 1995).
EPA Method 527: Determination of Selected Pesticides and Flame Retardants in Drinking Water by Solid Phase Extraction and Capillary Column Gas Chromatography/Mass Spectrometry (GC/MS) (USEPA, 2004b).
EPA Method 529: Determination of Explosives and Related Compounds in Drinking Water by Solid Phase Extraction and Capillary Column
Gas Chromatography/Mass Spectrometry (GC/MS) (USEPA, 2002a).
EPA Method 535, Revision 1.1: Measurement of Chloroacetanilide and Other Acetamide Herbicide Degradates in Drinking Water by Solid
Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) (USEPA, 2004c).
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b. Summary of Major Comments
Some commenters supported the
contaminant selection process in
general, but disagreed with EPA’s
criterion that pesticides must be
currently registered to be considered for
UCMR 2 because pesticides can persist
even after they are no longer in use. EPA
agrees that the issue of pesticides and
their degradates is an important one and
will consider, in future contaminant
selection processes, the commenters’
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concern about the requirement that
pesticides be registered. EPA did not
receive comments on its health effects
prioritization process.
Comments were received
recommending that EPA substantially
increase the number of UCMR 2
contaminants because of the large
number of contaminants that are
manufactured and sold in the United
States. Section 1445(a)(2)(B)(i) of SDWA
specifically limits the number of
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unregulated contaminants to 30 in each
UCMR five-year cycle. The UCMR 2 list
represents what EPA believes to be the
highest priority drinking water
contaminants for which monitoring
information is needed and obtainable.
Further comments indicated that EPA
needs to clarify the process for
prioritization of both UCMR and CCL
contaminants. In general, concern was
expressed that EPA did not sufficiently
explain the status of CCL research
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priorities, especially with respect to the
UCMR contaminant selection process.
In the August 2005 preamble to the
proposed rule, as well as in other past
Federal Register notifications, EPA has
explained in detail the connections
between the CCL and the UCMR
programs (https://www.epa.gov/
safewater/ucmr). The preamble to the
proposed UCMR 2 regulation presented
the logic behind the consideration of
potential analytes for the UCMR.
Section III ‘‘Requirements of the
Unregulated Contaminant Monitoring
Program’’ detailed all aspects of how
EPA selected the contaminants
proposed in this regulation with
subsections describing what priority
contaminants were selected for UCMR
2; a compilation of the initial list of
potential UCMR 2 candidates; how EPA
established priorities for UCMR 2; EPA’s
health effects prioritization approach;
and the specific information and
considerations that went into EPA’s
decisions on each analyte selected.
EPA has also been engaged in a multiyear process designed to create an
improved CCL process. This process
began after the first CCL was published
in 1998 and EPA expects the next CCL
(CCL 3) to reflect substantial progress in
implementing this new process. Because
the new CCL process was underway but
not yet completed in 2005, CCL 2
carried over the previous list and did
not reflect the changes EPA is expecting
to make in identifying contaminants for
possible regulation. EPA expects that
CCL 3 will reflect a more robust,
transparent, and systematic process to
identify priority contaminants in
drinking water that will form the
primary basis for future UCMR lists.
Before EPA can list a chemical
compound or microbiological parameter
on UCMR, adequate analytical methods
must be available. For some of the
chemicals (i.e., organotins, triazines and
algal toxins) and for all the
microbiological parameters listed on the
CCL, adequate analytical methods have
not yet been developed. EPA is actively
engaged in analytical method
development research for these
parameters both in-house and through
its various contracts and grant
mechanisms. EPA regularly publishes
journal articles and other reports on the
progress of all of these research
activities that are available for the
public to review.
2. Acetanilide Pesticides, Degradation
Products, and Related Methods
a. This Rule
Under this rule, the three highest-use
parent acetanilide compounds,
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acetochlor, alachlor, and metolachlor,
and their ESA and OA degradation
products are specified as List 2,
Screening Survey contaminants. The
final rule also specifies EPA Method
525.2 for analysis of the parent
compounds and EPA Method 535 for
analysis of the acetanilide degradates.
There were no changes between the
proposed and final rule language
regarding these priority contaminants
and their associated methods. However,
this rule contains revised language to
clarify that acetanilide parent and
degradation product sampling must be
conducted at the same time and same
location.
b. Summary of Major Comments
Some commenters did not agree with
EPA’s proposal to monitor the three
parent acetanilide compounds because
some water systems include these as
part of their regulated volatile organic
compound analyses using EPA Method
525.2. Another recommendation was
that no special certification for Method
525.2 be required, since many
laboratories are already approved to
conduct this analysis for regulated
contaminants. EPA is requiring
monitoring of these three parent
pesticides because it is essential that the
acetanilide parent and the degradation
products analysis be conducted using
samples collected in the same location
and at the same time to provide data on
their relative concentrations (i.e., to
establish relationships, if any, between
the two). In addition, because UCMR
requires only a sample of PWSs to
conduct monitoring, and the resulting
occurrence data is used to support EPA
decisions about whether to regulate a
contaminant to protect public health,
the quality of data collected, at
minimum reporting levels that are
considerably lower than those used for
compliance monitoring, is very
important. Therefore, the analyses must
meet even more stringent quality control
procedures than those used for other
national drinking water analyses, and
special approval of laboratories is
warranted for both EPA Method 535 and
525.2. These analyses are required as
part of the Screening Survey, and
therefore analytical costs to PWSs are
limited to approximately 720 large
systems (EPA is paying for the
analytical costs of small system
monitoring).
EPA agreed with recommendations in
public comment to require monitoring
for acetanilide parents and their
degradation products at the same
location and time to provide data on
their relative concentrations. The final
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373
regulation contains revised language to
include this requirement.
Finally, concern was expressed in
public comments that EPA may develop
a single maximum contaminant level
(MCL) for the parents plus their
degradates; commenters specifically
pointed out that different toxicity
endpoints may exist for parents and
degradates, and that a single MCL could
conflict with some state standards. EPA
has made no decision regarding whether
or how to regulate these compounds.
Such decisions are beyond the scope of
this rule.
3. Explosives and Related Methods
a. This Rule
Under this rule, EPA is requiring that
three explosives: Hexahydro-1,3,5trinitro-1,3,5-triazine (RDX), 1,3dinitrobenzene, and, 2,4,6trinitrotoluene (TNT) be monitored as
part of List 1, Assessment Monitoring.
The final rule also specifies EPA
Method 529 for analysis of these
compounds. There were no changes
between the proposed and final rule
language regarding these priority
contaminants and their associated
method.
b. Summary of Major Comments
Some commenters thought that other
contaminants may be more widespread
and should take priority over explosives
for testing. However, if monitoring for
explosives was required, the
commenters recommended that it be
limited to areas near munitions
facilities. The explosives have not yet
undergone a sufficiently widespread
occurrence study for EPA to be
confident that these contaminants are
only a concern near munitions facilities.
The decision to monitor for these
contaminants, versus others considered,
was driven by their potential health
effects through the process described
previously.
4. Perchlorate and Related Methods
a. This Rule
Under this rule, EPA has removed the
requirement for monitoring perchlorate
under the UCMR 2 program. All
references to perchlorate, its associated
methods, and specific quality control
requirements have been removed from
the final rule. As a result, the
requirements of § 141.40(a)(5)(v),
Detection Confirmation, were deleted,
and all subsequent sections have been
renumbered accordingly. The other rule
sections that were impacted by this
decision (with reference to perchlorate
or relevant analytical methods being
removed) are: § 141.40(a)(3)—Analytes
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to be monitored; § 141.40(a)(4)(i)(D)—
Sampling Instructions;
§ 141.40(a)(5)(i)—Sample collection/
preservation; and
§ 141.40(a)(5)(iii)(B)(2)—Quality control
requirements for validation of laboratory
performance at or below the MRL.
b. Summary of Major Comments
Approximately 75 percent of
commenters submitted comments on the
topic of perchlorate. The majority of the
commenters did not support an
additional round of perchlorate
monitoring, the most common reason
being the added cost of monitoring,
without the perceived potential for
gaining sufficient, new information.
Monitoring for perchlorate was
conducted during UCMR 1 in over 3,800
PWSs, with a minimum reporting level
of 4.0 micrograms per liter (µg/L). The
data collected during this survey
represents a statistically valid set of
high quality data that will inform EPA
on the occurrence and potential
exposure to perchlorate from public
drinking water supplies. EPA will
continue to evaluate these exposure data
along with other available information
(e.g., health effects) as the Agency
makes its regulatory determination.
Until that evaluation is complete, EPA
agrees with the commenters that it is not
clear that the Agency needs additional
information on the occurrence of
perchlorate in drinking water. As a
result, imposing additional perchlorate
monitoring costs on water systems is not
warranted at this time. Therefore, EPA
has removed the requirement for
monitoring perchlorate under the UCMR
2 program. If EPA later decides that
additional perchlorate monitoring is
warranted, the Agency will undertake
an appropriate rulemaking action.
5. Nitrosamines/NDMA and Related
Methods
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a. This Rule
This rule requires systems to monitor
for six nitrosamines as part of the List
2, Screening Survey. The final rule also
specifies EPA Method 521 for analysis
of these compounds. There were no
changes between the proposed and final
rule language regarding these priority
contaminants and their associated
method.
b. Summary of Major Comments
Some commenters thought that
nitrosamine sampling would be more
appropriately conducted as part of the
Stage 1 and Stage 2 DBPRs. EPA
disagrees with these comments for
several reasons. While in fact, to date,
the scientific literature identifies only
N-nitroso-dimethylamine (NDMA) and
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N-nitrosodiethylamine (NDEA) as
disinfection byproducts, the Screening
Survey for nitrosamines is designed to
aid in understanding the proportion of
nitrosamines, particularly NDMA, that
results from source water contamination
versus that which results from
disinfection. Also, the nitrosamines in
this regulation are all compounds
projected to have significant adverse
health effects. All of these compounds
are probable human carcinogens with
10¥6 cancer risk levels that are in the
low nanogram per liter range. These
compounds would be high priorities for
monitoring whether their occurrence is
the result of source water contamination
or disinfection.
Several commenters disagreed with
the use of Method 521, mostly because
of questions on the scope and extent of
interlaboratory testing and validation.
Commenters thought that methods that
are already being used by laboratories
should be allowed under UCMR.
Several commenters gave specific
suggestions as to which methods were
commonly in use that could be used for
UCMR monitoring.
The methods developed by EPA, for
this and other chemical methods needs
for the analysis of drinking water, were
subjected to a rigorous process that
included a series of testing, validation
studies and peer review, which went
beyond the proficiency testing or round
robin study of the alternative draft
unpublished methods suggested by the
commenters. Each individual procedure
of every method proposed by EPA was
subjected to rigorous testing for a
minimum of two years using
scientifically sound procedures. EPA’s
review of the suggested alternative draft
methods also identified technical
deficiencies that preclude their approval
for monitoring under UCMR 2.
6. Flame Retardants, Other Priority
Contaminants, and Related Methods
a. This Rule
Under this rule, EPA is requiring
monitoring for five flame retardants, as
well as terbufos sulfone and dimethoate,
as part of List 1, Assessment
Monitoring. The final rule also specifies
EPA Method 527 for analysis of these
compounds. There were no changes
between the proposed and final rule
language regarding these priority
contaminants and their associated
method.
b. Summary of Major Comments
Concern was raised through public
comment that only one citation was
provided in the proposed rule preamble
supporting the rationale for choosing
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this group of contaminants. Public
comment suggestions were made that
there may be other groups of
contaminants, such as endocrine
disruptors, that would be a better choice
than the flame retardants. EPA notes
that both Darnerud, 2001 and Hites,
2004 were cited in the preamble of the
proposed regulation as sources of the
statements concerning flame retardants.
There are however, many additional
articles in the scientific literature which
could have also been cited. In an article
entitled ‘‘An overview of brominated
flame retardants in the environment’’ by
Cynthia A. deWit, which was published
in Chemosphere, 46 (2002), the author
cites over 180 published articles on
flame retardants. In addition, three
published articles; T.E. Stoker,
‘‘Toxicology and Applied
Pharmacology’’, 207 (2005); T.A.
McDonald, ‘‘Chemosphere’’, 46 (2002);
and I.A.T.M. Meerts, ‘‘Environmental
Health Perspectives’’, 109 Vol. 4 (2001)
concern tests that have been performed
which support that the flame retardants
specified for monitoring in UCMR 2 are
endocrine disruptors.
7. Triazines Chlorodegradates and
Parent Compounds
a. This Rule
In the proposed rule preamble, EPA
solicited public comment regarding
three triazine chlorodegradates and
three of their parent compounds
because the Agency is conducting a
cumulative risk assessment for the
chlorodegradates as a group with
atrazine, simazine, and propazine.
While atrazine and simazine are already
regulated under NPDWRs, EPA was
considering UCMR monitoring for these
parent compounds concurrent with the
collection of UCMR data for their
degradation products to determine the
degree of correlation between the
occurrence of the parents and their
degrades. Though public comment was
requested, triazines were not officially
proposed for inclusion under UCMR 2
monitoring. There were no changes
between the proposed and final rule
language, and thus, the triazines are not
part of the UCMR 2 monitoring
requirements.
b. Summary of Major Comments
Commenter opinion varied regarding
inclusion of triazines in UCMR 2
monitoring. For those that supported
their inclusion, the primary reason was
health effects. One of these commenters
also recommended that cyanizine be
included in this contaminant group. Of
those who opposed including this
group, the following reasons were given:
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concern about laboratory capacity if two
similar analyses using liquid
chromatography/tandem mass
spectrometry (LC/MS/MS) were
required to be conducted in the same
time frame; concern regarding the status
of method development; the belief that
the manufacturer should pay for
occurrence testing; and the fact that
information on the parent compounds is
already available.
Although validation of a new triazine
method has been completed, EPA agrees
that requiring the use of two LC/MS/MS
methods in the same UCMR cycle could
present a laboratory capacity problem.
Due to these concerns, EPA has
concluded that triazine monitoring
should be postponed until a future cycle
of the UCMR.
8. Other Compounds That Were
Considered
a. This Rule
In identifying the target contaminants
for this rule, EPA began with a list of
over 200 contaminants, compiled from a
variety of different sources, including:
UCMR 1 reserved contaminants; CCL 1
deferred pesticides; CCL 1 suspected
endocrine disruptors; and other
emerging contaminants. Through a
multi-stepped review and prioritization
process, the list was narrowed and
prioritized. EPA’s final prioritization
was based on the available relative
health effects information for each
compound.
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b. Summary of Major Comments
EPA received comment encouraging
the Agency to include some endocrine
disruptors on the UCMR 2 contaminant
list. The initial list that EPA compiled
included several contaminants that were
identified as suspected endocrine
disruptors during CCL 1 development,
as well as others that are widely
suspected to be endocrine disruptors.
EPA used a multi-stepped review and
prioritization process to select 25
contaminants for monitoring from the
broader pool of 200 contaminants.
Several different health effects criteria
were used to prioritize contaminants in
addition to endocrine disruption, such
as cancer classification and toxicity.
Although some contaminants that are
considered endocrine disruptors are not
part of the final monitoring list, all five
flame retardants that are part of UCMR
2 are suspected endocrine disruptors. In
addition, EPA will consider these other
contaminants for monitoring in future
rounds of UCMR monitoring.
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D. How Are Laboratories Approved for
UCMR 2 Monitoring?
1. This Rule
The UCMR 2 laboratory approval
process is designed to assess whether
laboratories meet the required
equipment, laboratory performance, and
data reporting criteria. Laboratories
wishing to participate in UCMR 2 must
contact EPA to be considered. This rule
requires laboratories to complete and
submit their registration to EPA by April
4, 2007 (i.e., within 90 days of final rule
publication). To be approved to conduct
UCMR testing, this rule requires that the
laboratory be certified under § 141.28
for one or more compliance analyses;
demonstrate, for each analytical method
it plans to use for UCMR testing, that it
can meet the Initial Demonstration of
Capability (IDC) requirements and
successfully participate in the UCMR
Proficiency Testing (PT) Program; and
has the capability to post monitoring
data to EPA’s electronic reporting
system. Laboratories are encouraged to
apply for UCMR 2 approval as early as
possible. The steps for the laboratory
approval process are as follows:
a. Request To Participate
The laboratory must contact EPA
requesting to participate in the UCMR 2
laboratory approval process.
Laboratories must send this request to:
UCMR 2 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 began accepting participation
requests for the methods associated with
UCMR 2 (including List 1, Assessment
Monitoring, and List 2, Screening
Survey) following publication of the
proposed rule on August 22, 2005. The
laboratory must complete and submit
the necessary registration by April 4,
2007.
b. Registration
EPA will send each laboratory that
requests a registration package a list of
information that EPA will need to
process that application. This
registration information will provide
EPA with the basic information about
the candidate laboratory including:
Laboratory name; mailing address;
shipping address; contact name; phone
number; fax number; e-mail address;
and UCMR 2 methods for which the
laboratory is seeking approval. Thus, the
purpose of the registration step is to
ensure that EPA has all of the necessary
contact information and that each
laboratory receives a customized
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375
application package, which will include
materials and instructions for the
methods that it plans to use.
c. Application Package
When EPA receives the registration
information, an application package will
be sent to the laboratory for completion.
This application package will be
customized to address only those EPA
methods selected in the laboratory’s
registration. EPA may provide analytical
standards to be used when conducting
monitoring; however, laboratories will
be required to procure their own
standards, where commercially
available, to be used to complete the
application process. Information
requested in the application will
include:
• IDC data, including precision,
accuracy, and MRL studies;
• Information regarding analytical
equipment;
• Proof of current drinking water
laboratory certification; and
• Example chromatograms for each
method under review.
The laboratory must also confirm that
it will post UCMR 2 monitoring results
(on behalf of its PWS clients) to EPA’s
UCMR electronic data reporting system.
d. EPA Review of Application Package
EPA will review the application
package and, if necessary, request
follow-up information. Satisfactory
completion of this portion of the process
will allow the laboratory to participate
in the UCMR 2 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 must successfully analyze
UCMR 2 PT sample(s) for each method
for which the laboratory is seeking
approval. A laboratory must pass only
one PT for each of the UCMR 2
methods. Laboratories applying for
UCMR 2 approval, and laboratories
conducting UCMR 2 analyses, may be
subject to on-site laboratory audits. No
PT studies will be conducted after the
start of monitoring. Laboratories will not
be approved if they did not successfully
complete a PT study.
f. Written EPA Approval
After the first five steps (a–e, above)
have been successfully completed, EPA
will send the laboratory a letter listing
the methods for which approval is
granted. These letters will also include
a reminder that the laboratory may be
subject to on-site audits. A list of
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laboratories approved for UCMR 2 will
be posted to EPA’s UCMR Web site:
https://www.epa.gov/safewater/ucmr/
ucmr2/labs.html.
2. Summary of Major Comments
Several comments recommended that
EPA continue to oversee the laboratory
approval process and offer PTs
throughout the UCMR 2 period to
ensure that approved laboratories are
maintaining data quality. EPA notes that
the laboratory approval process is meant
to establish a list of laboratories that
have demonstrated their ability to
perform the Quality Assurance/Quality
Control (QA/QC) requirements for
UCMR 2 methods. EPA and its
supporting contractor will be assisting
candidate laboratories to achieve the
required proficiency during the
laboratory approval process. Once the
approvals are completed, EPA does not
intend to invest the resources to
maintain an ongoing laboratory
monitoring program. However, EPA will
continue to provide technical assistance
to laboratories that request it. In
addition, EPA will conduct a limited
number of on-site laboratory audits.
PWSs also have a role to play in data
quality. In selecting a laboratory for
conducting UCMR 2 analyses, the PWS
should consider the laboratory’s
commitment to data quality. As a
partner in the commitment to quality
data, the PWS should request and
review the QC data associated with their
UCMR 2 occurrence samples.
Public comments also expressed
concern that there may not be adequate
time for laboratories to receive
certification, resulting in reduced
laboratory capacity at the onset of
monitoring. Recommendations
included: Adjusting monitoring
schedules in instances of inadequate
laboratory capacity; conducting the
laboratory approval process prior to rule
promulgation; and extending the
deadline for laboratories to report
monitoring results. EPA began offering
the first round of preliminary laboratory
PTs in mid-2006. Additional rounds
were conducted before and are
scheduled to be conducted after
promulgation of the final regulation.
EPA is confident that sufficient
laboratory capacity will be available, but
will also closely evaluate the results of
these preliminary PTs.
In addition, this rule contains
language that revises the Screening
Survey and Assessment Monitoring time
frame to January 2008 through
December 2010. This revision extends
the start date of UCMR 2 monitoring by
6 months from the proposed July 2007
start date and allows the Screening
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Survey to be conducted across three
years as opposed to the two-year time
frame that was proposed. This will
allow PWSs more time for UCMR 2
planning and budgeting and provide
additional assurance of sufficient
laboratory capacity.
E. What Is A System’s Responsibility
Regarding the Use of Laboratories?
1. This Rule
Under this rule, systems selected to
participate in monitoring will be
required to use laboratories that are
approved by EPA for UCMR 2
monitoring (see Section III.D, above).
Large systems must ensure that the
laboratories conducting their analyses
meet UCMR 2 QC requirements and post
the data in EPA’s electronic data
reporting system within 120 days of the
sample collection date.
2. Summary of Major Comments
Several comments were received
regarding PWSs’ responsibility for
laboratory compliance with QC and
reporting requirements, indicating that
EPA should be responsible for ensuring
laboratory compliance, as a condition of
certification.
PWSs have always been responsible
for the quality of the results produced
by the laboratory they employ, whether
that monitoring was conducted in
support of UCMR 1 or compliance
monitoring under SDWA. Large PWSs
(serving greater than 10,000 people)
must ensure that their laboratories have
received appropriate EPA approvals to
conduct UCMR 2 methods and must
ensure that laboratories follow the
specific UCMR 2 QC requirements. EPA
recommends that laboratory
requirements be addressed in the
contractual language between the PWS
and laboratory. EPA’s UCMR Web site
at: https://www.epa.gov/safewater/ucmr/
ucmr2 provides informational materials
that PWSs can use to help them evaluate
their data. These materials include: a
laboratory approval manual, the
analytical methods (each of which
contain a table summarizing QC
requirements of that method), and a
general reference guide designed to help
PWSs develop laboratory contracts.
F. What Specific Quality Control
Requirements Must Be Followed?
1. Method Development Approach and
Method Defined Quality Control
a. This Rule
Under this rule, UCMR 2 analyses
will be conducted using five EPA
methods. This final rule revises several
aspects of the methods QC requirements
compared to those that were established
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under UCMR 1, including: revising the
definition of and procedures for MRL
detection limits (see Section III.F.2. for
more detail); and no longer requiring QC
samples because standards are generally
not available. The final rule language
also contains other revisions to QC
requirements that were necessary
because of the removal of perchlorate
from the final UCMR 2 monitoring list.
See Section III.C.4 for a listing of those
changes.
b. Summary of Major Comments
A few commenters were concerned
that the methods have not been properly
validated, potentially increasing costs if
repeat sampling is needed. These
commenters also believe that laboratory
capacity would be insufficient to
conduct all required monitoring.
As noted elsewhere, EPA is confident
that the analytical method validation
procedures that it has followed provide
the appropriate evaluation of analytical
methods and that the design of the
Assessment Monitoring and Screening
Surveys ensures that adequate
laboratory capacity will be available.
Moreover, as noted elsewhere, the final
rule extends the time frame for
Screening Survey monitoring from two
years (as originally proposed) to three
years, coinciding with Assessment
Monitoring. This extended timeframe
will further enable approved
laboratories to handle the analyses
associated with UCMR 2 monitoring.
EPA received comments disagreeing
with its proposal to no longer require
QC samples, arguing that this will
diminish the quality of the analyses,
and that companies that manufacture
QC standards will have them available
in 2006. A quality control sample, in
this context, is a primary dilution
standard of methods analytes that is
obtained from a source external to the
laboratory and different from the source
of calibration standards. Although EPA
agrees that the periodic measurement of
a QC sample is an important element of
standard laboratory quality control, it is
not feasible to require the use of QC
samples that do not currently exist and
may or may not exist in the future. In
addition, all laboratories will be
required to pass an EPA performance
study, which will help to assure the
quality of the calibration standards
being used. However, EPA is strongly
encouraging all UCMR laboratories to
analyze an independently prepared
quantitative standard on a quarterly
basis. If commercially prepared QC
standards are available, they should be
used. If not, laboratories should have a
second analyst prepare a separate set of
quantitative standards to serve as
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independent quality control checks of
the calibration standards being used by
the laboratory. EPA will continue to
require that UCMR laboratories analyze
a variety of other samples (i.e., duplicate
samples, laboratory fortified reagent and
matrix samples, etc.) designed to assess
the quality of their analyses, as specified
in each analytical method and in the
‘‘UCMR 2 Laboratory Approval Manual’’
(USEPA, 2004d).
2. Minimum Reporting Level
a. This Rule
Under this rule, all laboratories
certified to conduct UCMR analysis
must be able to demonstrate their ability
to detect each UCMR contaminant at the
specified MRL. MRLs represent an
estimate of the lowest concentration of
a compound that can be quantitatively
measured by a group of experienced
drinking water laboratories. Previously,
MRLs had been determined by
analytical laboratories using expert
professional judgment, but standard
criteria for MRL determinations had not
been established. For this rule, EPA has
revised the process for developing MRLs
as follows. The MRLs are now based on
Lowest Concentration Minimum
Reporting Levels (LCMRLs) which were
determined by each laboratory that
developed or subsequently tested the
methods. LCMRLs represent the lowest
concentration of a compound that can
be quantitatively determined in each
individual laboratory. In the interest of
greater consistency, EPA has developed
a statistical protocol for singlelaboratory determinations of LCMRLs,
using linear regression and prediction
intervals.
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b. Summary of Major Comments
Several comments were received
regarding the number of significant
figures associated with the MRLs. These
commenters wanted the number of
significant figures reduced. In
considering public comments, EPA
agrees that the MRLs should be reported
to one significant figure. The final
regulation contains revised language
reflecting that MRLs are rounded to one
significant figure.
Commenters also thought that having
a different MRL for each analyte may
lead to calibration errors. They
suggested revising the MRLs within
each method to achieve some
proportional relationship among the
MRLs. EPA does not agree with this
comment. The MRLs are based upon a
statistical analysis of the quantitation
levels achieved at multiple laboratories.
To adjust those to some proportional
level would be arbitrary.
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3. Lowest Concentration Minimum
Reporting Level
a. This Rule
EPA has developed a protocol for
developing MRLs based on LCMRLs
determined by each laboratory that
developed or subsequently tested the
methods listed in this action. For UCMR
1, EPA specified MRLs and a
requirement for recovery at the MRL so
that data quality was documented daily.
In the interest of greater consistency,
EPA developed a statistical protocol for
single-laboratory determinations of
LCMRLs using linear regression and
prediction intervals. This approach has
been evaluated through expert peer
review conducted in accordance with
the Agency’s formal peer review process
and through the performance of a pilotscale interlaboratory study. A free tool
for calculating the LCMRL was
developed and is available for download
on the Web: https://www.epa.gov/
safewater/methods/
sourcalt.html#Mlcmrl.
b. Summary of Major Comments
Some public commenters disagreed
with the 50–150 percent acceptance
criteria for MRLs, arguing that it exceeds
routinely accepted criteria, and
suggested instead to use ± 10–20
percent. EPA believes that these
commenters are referring to ± 10–20%
relative standard deviation (RSD) and
notes that the MRL verification
requirement is based on the three sigma
prediction interval being within 50–150
percent. EPA believes that the 50–150
percent criteria is in fact, a very
stringent requirement comparable to
that advocated by the commenters. As
an example, to meet the 50–150 percent
criteria for the 99 percent prediction
interval, as specified in
§ 141.40(a)(5)(iii), and assuming 100
percent accuracy, would require an RSD
of 13.5 percent. Since both precision
and accuracy are measured by this
criterion, any errors in accuracy would
serve to reduce the required RSD even
further, and make the precision criteria
more stringent.
Other comments expressed concern
that acceptance criteria were not
consistently applied, possibly leading to
inconsistencies in the precision and
accuracy of reported values. EPA agrees
that the LCMRL process, as specified in
the proposed regulation, does not apply
consistent acceptance criteria over the
analytical range of the test method. EPA
has always recognized that precision
and accuracy of analytical methods are
a function of concentration, and has
generally published differing acceptance
criteria for its methods in recognition of
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this fact. These concentration-based
criteria do not in any way represent a
change in policy, rather, recognition of
the reality of analytical measurements.
4. Laboratory Fortified Sample Matrix
and Laboratory Fortified Sample Matrix
Duplicate
a. This Rule
Under this rule, all participating
laboratories will be required to analyze
Laboratory Fortified Sample Matrix
(LFSM) samples for accuracy, and
Laboratory Fortified Sample Matrix
Duplicate (LFSMD) samples for
precision, for all UCMR 2 contaminants.
LFSM/LFSMD samples must be
prepared using a sample collected and
analyzed in accordance with UCMR 2
requirements and analyzed at a
frequency of 5 percent (or one 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 percent of the time.
The low-level LFSM/LFSMD
fortification concentration must be
within ± 50 percent of the MRL for each
contaminant, and the mid-level LFSM/
LFSMD fortification concentration must
be within ± 20 percent of the mid-level
calibration standard for each
contaminant. The low-level method
fortification level requirement of ± 50
percent represents a revision to the
proposed rule language based on public
comments that ± 20 percent was too
restrictive.
b. Summary of Major Comments
Some commenters expressed
concerned about the added expense of
extra bottles and the time needed to
coordinate with laboratories and other
utilities to ensure that the proper
number of LFSM/LFSMD samples will
be submitted. Although EPA has
changed the way that QC data will be
tracked, EPA has not changed the
number of sample bottles which need to
be collected. The requirement to fortify
at least one UCMR field sample per
analytical batch, and to report these data
to EPA, has not changed from UCMR 1.
The only change compared to UCMR 1
is in how the data are to be reported.
Previously, laboratories were required to
report the percent recoveries of each
analyte in the fortified field samples; in
UCMR 2 they are required to report the
analytical result and EPA will compute
the recoveries.
Other commenters suggested using
the same sample for duplicates instead
of a second sample and using more
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laboratory blanks to decrease cost. EPA
notes that data from laboratory blanks
and fortified matrix samples provide
very different information. Data from
fortified reagent water samples help the
data user understand how well the
laboratory is performing the analysis.
Fortified matrix samples are used to
determine if there are interfering
compounds in the matrix that preclude
accurate analysis and to assess the
precision and accuracy of the database
of field results. Since fortified reagent
water samples are not subject to the
same type of matrix interferences that
field samples are, data from reagent
water samples are not a scientifically
valid way to determine the precision
and accuracy of field data.
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G. When Are Samples Collected?
1. This Rule
To accommodate PWS preparation for
rule implementation and to provide
additional assurance of sufficient
laboratory capacity, this rule contains
revised language that changes the start
of monitoring from July 2007 to January
2008, such that the effective monitoring
period is now January 2008 through
December 2010. This rule also contains
language that revises the Screening
Survey time frame to match that of
Assessment Monitoring. Thus,
Screening Survey systems will be
scheduled to monitor during a
continuous 12-month period during
January 2008 through December 2010.
In addition, as under UCMR 1, ground
water sampling points must be
monitored twice in a consecutive
12-month period. However, to provide
PWSs with more flexibility, the final
rule contains revised language to allow
the second sampling event for ground
water sampling points to occur within
5–7 months of the first sampling event
instead of within 6 months, as
proposed. EPA will establish schedules
for all systems to ensure adequate
laboratory capacity for the analysis of
UCMR contaminants and to improve the
oversight of monitoring and data
reporting. EPA will use the State
Monitoring Plans to identify all systems
that will participate in the UCMR 2
program, and to identify the monitoring
schedule for each system.
This action also contains language
that clarifies the definition of a
sampling location’s source type. The
final rule language specifies that if any
percentage of the total water associated
with a sampling point originates either
from surface water or ground water
under the direct influence of surface
water (GWUDI) during the 12-month
monitoring period, then that source
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should be reported as ‘‘SW’’ or ‘‘GU’’ as
appropriate. These sampling points
must be monitored for four consecutive
quarters, with sample events occurring
three months apart (e.g., a system could
conduct monitoring in either: (1)
January, April, July, October; (2)
February, May, August, November; or
(3) March, June, September, December).
2. Summary of Major Comments
Many commenters did not support
EPA’s proposal to designate each PWS’s
month and year of monitoring,
expressing concern for budget and
scheduling, and some specific concerns
that the assigned schedule could
conflict with the Initial Distribution
System Evaluation (IDSE) that is
required under the Stage 2 DBPR.
Alternatives recommended by
commenters included: setting a
‘‘window’’ in which monitoring must be
completed; allowing systems to conduct
monitoring over the entire monitoring
period; and allowing systems to set their
own schedules. Some commenters
recommended that EPA change the
Screening Survey time frame to match
that of Assessment Monitoring; others
recommended delaying the start of the
Screening Survey by one year. Based on
its experience with UCMR 1, EPA has
determined that establishing a defined
schedule (month and year) for each
PWS is necessary. Under UCMR 1, EPA
did not establish Assessment
Monitoring schedules for large systems.
This resulted in delayed or incomplete
monitoring for a number of large
systems, leading to enforcement actions
that may have been avoided had
schedules been established. To help
PWSs with scheduling and to provide
additional assurance of laboratory
capacity, the final regulation contains
revised language that: (1) Changes the
monitoring period for UCMR 2 from July
2007 through June 2010 to January 2008
through December 2010; and (2) extends
the two-year monitoring period for the
List 2 Screening Survey contaminants to
three years, such that the Screening
Survey will coincide with the three-year
Assessment Monitoring period of
January 2008 through December 2010.
In addition, systems will have the
opportunity to change their sampling
schedules either through EPA’s
electronic data reporting system by
August 2, 2007, or after this date by fax,
mail, or e-mail request to EPA.
Some commenters indicated that
wells may not be operating continually
and therefore, some systems with
ground water sources will be unable to
meet EPA’s schedule. Some
recommended that EPA allow systems
to conduct the second sampling event
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within 5–7 months of the first sample,
as was done under UCMR 1. In response
to this recommendation, the final
regulation contains revised language
that extends the time frame for
collecting the second ground water
sample to 5–7 months following the
collection of the first round of samples.
For planning purposes, EPA will
initially schedule these sampling events
6 months apart. However, systems will
have the flexibility to sample within a
5–7 month window. Systems will be
required to notify EPA if they cannot
monitor within this 3-month window.
Refer to Section III.J.1.c for more detail
on the requirement for a water system
to notify EPA if it is unable to monitor
according to its assigned schedule.
H. Where Are Samples Collected?
1. Entry Points to the Distribution
System
a. This Rule
This rule establishes that all UCMR 2
samples will be collected at entry points
to the distribution system (EPTDSs), and
for nitrosamines, within the distribution
system, and eliminates the option of
source water monitoring (except for
source water that leaves the EPTDS
untreated).
b. Summary of Major Comments
Several commenters disagreed with
EPA’s proposal to eliminate monitoring
from ‘‘raw source water’’ samples.
Several reasons were given, including:
Cost savings through coordination with
compliance monitoring; raw water
samples would provide useful
information for determining which
water treatment technologies are needed
and potential human exposure; and EPA
allowed systems the option of sampling
raw water or EPTDS locations under
UCMR 1. Other alternatives suggested
were to allow systems with multiple
source water sampling locations to
collect a sample from the highest risk
source based on their Source Water
Assessments, and to require a portion of
large systems with surface water sources
to conduct raw water sampling under
Assessment Monitoring.
In response to these comments, EPA
notes that the UCMR design was
established in fulfillment of the 1996
SDWA Amendments (Section
1445(a)(2)), which states: ‘‘The
regulations shall require monitoring of
drinking water supplied by public water
systems * * *’’ The UCMR program
was designed to collect data that would
provide information for human
exposure study. This is best achieved by
conducting monitoring at the EPTDS as
opposed to a pre-treatment sampling
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site. However, to provide flexibility
during UCMR 1, systems were allowed
to collect ‘‘raw source water’’ samples in
those States where samples for regulated
contaminants were collected prior to
treatment. If a system detected any
contaminants above the MRL (and
treatment was subsequently applied),
monitoring at EPTDSs was subsequently
required. This created substantial
confusion and errant reporting during
UCMR 1; many systems did not fully
understand or comply with the
requirement to conduct the required
EPTDS monitoring following a raw
water detection. EPA anticipates that
this confusion would be even more
likely during UCMR 2 if raw water
monitoring was allowed because of the
anticipated occurrence rates for some
UCMR 2 analytes. Moreover, since
UCMR 2 methods are not used to
support regulated contaminant
monitoring, UCMR 2 samples cannot be
used to meet compliance monitoring
requirements.
2. Distribution System Maximum
Residence Time
a. This Rule
This rule requires systems that are
participating in the Screening Survey to
collect nitrosamine samples both at
EPTDSs and in the distribution system
to capture the occurrence of
nitrosamines as disinfection byproducts.
This rule requires systems to collect
their nitrosamine samples at their
distribution system maximum residence
time (DSMRT) location(s) for each
treatment plant/water source as defined
in the Stage 1 DBPR. Water systems that
do not have defined DSMRT sampling
points in the distribution system (e.g.,
systems that do not apply a chemical
disinfectant, wholesalers without retail
customers) will be required to collect
nitrosamine samples at EPTDSs only.
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b. Summary of Major Comments
EPA requested comment on whether
nitrosamines should be collected at both
EPTDSs and at the DSMRT for each
treatment plant/water source as defined
in Stage 1 DBPR. A few commenters
agreed that this monitoring should
occur at both sampling locations. Some
commenters disagreed with sampling
finished water, saying that EPA will be
unable to determine whether NDMA
occurs in the source or is formed as a
disinfection byproduct (DBP) without
raw water data or information on the
disinfection level at the time of sample
collection. In addition, commenters
pointed out that treatment can reduce
the concentration of some contaminants.
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EPA is requiring that nitrosamine
samples be collected at two locations to
allow the Agency to evaluate whether
exposure to nitrosamines is influenced
by the distribution system. Since the
nitrosamines may occur as source water
contaminants and/or DBPs, monitoring
at both the EPTDSs and DSMRTs will
provide EPA with the range of human
exposures to these contaminants in
drinking water. In addition, if a
nitrosamine is present as a result of
reactions with the disinfectant, the
concentration may increase the longer
the water is in contact with that
disinfectant. EPA plans to compare the
aggregated concentration data from the
two sample points to determine if there
is a significant difference in the
concentrations. This information will
assist EPA in determining an
appropriate sampling strategy if a
decision to regulate nitrosamines is
made after the UCMR 2 exposure
information is available. EPA will also
evaluate differences between systems
using free chlorine versus chloramines
to determine if the type of residual
disinfectant is associated with
nitrosamine levels.
EPA agrees that the UCMR 2 data will
not establish the source of nitrosamines,
if they are present in finished water.
However, the Agency does not agree
that raw water data would necessarily
establish the source of nitrosamine
contamination. Some coagulant aid
polymers used in drinking water
treatment have been implicated as
precursors of nitrosamines. The
inability to identify the source of the
contaminant is not limited to
nitrosamines; it extends to all UCMR 2
contaminants. The UCMR program was
designed to collect data that would
provide information for human
exposure study. This is best achieved by
conducting monitoring at the EPTDS as
opposed to a pre-treatment sampling
site because the treatment process can
influence the concentration present in
drinking water.
Several public comments were
received regarding the timing of UCMR
2 monitoring and the completion of
IDSEs. Commenters were concerned that
most systems have not begun their
IDSEs to identify the longest residence
time in their system, and thus, DSMRT
locations may not be available for
nitrosamine occurrence testing. During
UCMR 2 implementation, disinfecting
systems will conduct monitoring at the
Stage 1 DBPR distribution system
sampling locations. These locations
reflect the water system’s and Primary
Agency’s judgment concerning areas in
the distribution system that have the
‘‘oldest’’ water (i.e., those locations with
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the greatest distribution system
maximum residence times or DSMRT).
Under the Stage 2 DBPR, systems will
be required to conduct IDSEs to
determine locations with representative
high total trihalomethanes (TTHM) and
haloacetic acids (HAA5) concentrations.
EPA agrees that new information
collected during the IDSE study may
result in the water system no longer
using the Stage 1 DSMRT sampling
locations because other areas of the
distribution system may have higher
concentrations of TTHM or HAA5.
However, EPA believes it is still
appropriate to use the Stage 1 DSMRT
sample locations for the UCMR 2
monitoring because it is premature to
link nitrosamine occurrence levels to
TTHM and HAA5 levels. In addition, no
water system is required to conduct
Stage 2 compliance monitoring until
2012, long after UCMR 2 monitoring is
complete.
I. How Should Samples Be Collected?
1. This Rule
This rule includes clarifying language
that acetanilide parent compounds and
their degradates must be collected at the
same time and sampling location
(§ 141.40(a)(4)(i)(D)). Refer to Section
III.C.2 for a more detailed discussion of
comments pertaining to acetanilides.
This rule also revises system resampling
requirements related to laboratory errors
or sampling deviations
(§ 141.40(a)(4)(i)(G)). Previously,
systems were required to resample
within 14 days of becoming aware of a
sampling or laboratory error. Systems
will now have 30 days to collect the
resample. This rule also retains the
instruction that sample collection and
shipping take place Monday–Thursday
to ensure that samples arrive at the
laboratory at the required temperature.
2. Summary of Major Comments
EPA agreed with comments that
recommended acetanilide parent and
the degradation products analysis be
conducted using samples collected in
the same location, and at the same time,
to provide data on their relative
concentrations. The final regulation
contains revised language to specify that
acetanilide parent and degradation
product sampling be conducted at the
same time and at the same site.
Several public comments were
received indicating that a resampling
period of 14 days is too short. Some
made recommendations for extending
the period to within 30 days of receiving
written notification that a laboratory
error had occurred or after the system
determines that a sampling error has
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occurred. Others recommended up to
two months. In response to these
comments, EPA has included revisions
to the final regulation requiring
resampling to occur within 30 days of
being informed or becoming aware of
the sampling or laboratory error.
Extending the resampling period
beyond 30 days would result in a large
number of resamples being collected in
the next quarterly monitoring period.
J. What Are the UCMR 2 Reporting
Requirements?
1. Information Required Prior to
Monitoring
a. Contact Information
This rule finalizes the proposed
requirement for water systems to report
contact information (i.e., the name,
affiliation, mailing address, phone
number, fax number, and e-mail address
of the PWS Technical Contact and PWS
Official) to EPA. Large systems (those
serving 10,000 or more people) must
submit this information by April 4, 2007
using EPA’s electronic data reporting
system. Small systems, or States (if
acting on their behalf) must submit this
information within 90 days of receiving
a letter from EPA that requests contact
information. EPA did not receive any
comments regarding these requirements.
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b. Sampling Location and Inventory
Information
i. This Rule
This rule finalizes the proposed
requirement for large PWSs to provide
inventory information for each of their
required sampling locations by August
2, 2007 (i.e., within 210 days of final
rule publication) using EPA’s electronic
reporting system. For each sampling
location, or for each approved
representative sampling location, large
systems must submit the following:
public water system identification
(PWSID) code; PWS facility
identification code; sampling point
identification code; sampling point type
code; and sampling location water type.
Any changes to these data must be
reported to EPA’s electronic reporting
system within 30 days of the change.
Section III.J.3.b of this action includes a
more detailed discussion of EPA’s
electronic reporting system.
ii. Summary of major comments
Some commenters recommended that
existing inventory information from the
Safe Drinking Water Accession and
Review System (SDWARS) or other
databases, such as EPA’s Safe Drinking
Water Information System (SDWIS), be
used to pre-populate the database for
UCMR 2 to reduce some of the burden
on water systems. EPA will use the large
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system inventory that is currently stored
in SDWARS 1 as much as possible, and
supplement that with new entry point
facilities from SDWIS, as well as new
information provided by the State.
PWSs will be responsible for verifying,
correcting, and updating inventory
information. PWSs will identify the
facilities/sample points that are required
to be sampled (i.e., all EPTDSs or
approved representative EPTDSs
sampling points, as well as applicable
DSMRT sampling points). PWSs that are
required to monitor in the distribution
system will have the opportunity in
SDWARS to associate the distribution
system sample point with an entry
point.
c. Proposals for Representative
Sampling Locations
i. This Rule
Under this action, some large systems
that have multiple ground water
EPTDSs can request approval to monitor
at representative entry point(s) rather
than at each EPTDS. Large PWSs can
submit either documentation of
alternate EPTDS sampling locations that
were approved by the State or EPA for
UCMR 1 or Phase II/V monitoring, or a
proposal for sampling at representative
EPTDS(s), with supporting
documentation to demonstrate that any
EPTDS selected as representative of the
ground water supplied from multiple
wells is associated with an individual
well that draws from the same aquifer
as the multiple wells (i.e., those being
represented).
ii. Summary of Major Comments
Many commenters agreed with EPA’s
proposal to allow ground water systems
to use representative entry points. Some
indicated that EPA should allow more
flexibility in the type of data used to
support the selection of representative
EPTDSs. In particular, some
commenters suggested that EPA allow
any previously approved representative
monitoring plans used for UCMR 1
(including those approved by EPA) as
appropriate documentation.
Commenters also indicated that some
systems may need more than 210 days
after the publication date to prepare a
representative well proposal and that
EPA should extend this deadline.
In response to comments, the final
regulation contains revised language to
allow PWSs to submit documentation of
a representative well plan approved in
previous UCMR cycles
(§ 141.35(c)(3)(i)). However, EPA is not
revising the rule language that lists
examples of the types of information a
PWS may submit to demonstrate the
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representativeness of a well
(§ 141.35(c)(3)(ii)). The situation and
available data will vary too widely from
PWS to PWS for EPA to specify the
exact data that are necessary. Further,
EPA believes that the time frame for
submitting representative proposals is
reasonable and notes that systems were
made aware of this opportunity shortly
after the publication of the proposed
rule.
d. Reporting/Coordination of
Monitoring Schedules for Large Systems
i. This Rule
Under UCMR 2, EPA will establish
monitoring schedules for all
participating systems. Large systems
have until August 2, 2007 (i.e., 210 days
from the publication of this final rule)
to revise their schedule using the EPA
electronic data reporting system. After
August 2, 2007, if a large PWS cannot
sample according to the required
schedule, the PWS Official must fax,
mail, or e-mail a request to EPA
explaining the reason samples cannot be
taken according to the assigned
schedule and requesting an alternative
schedule. This rule also contains
revised language clarifying that the
second set of samples from ground
water sources may be collected any time
within 5–7 months of the first sampling
event without the PWS being required
to notify EPA.
ii. Summary of Major Comments
Some commenters recommended that
the 210-day deadline for submitting a
revised monitoring schedule be
removed and systems be allowed to
conduct monitoring at any time during
the entire three-year time frame.
Commenters indicated that the deadline
would limit a water system’s ability to
coordinate its monitoring schedule with
a contract laboratory’s analytical
capacity, and would result in an
increased likelihood of monitoring and
reporting violations due to operational
failures beyond the water system’s
control. As discussed in Section III.J.1.d
of this preamble, EPA will establish a
defined schedule (month and year) for
each PWS. During the 210-day period
following publication of the final
regulation (i.e., August 2, 2007), a PWS
can simply revise its schedule using the
EPA electronic data reporting system.
Barring a serious problem with large
numbers of PWSs wanting to change
their scheduled monitoring to the same
time frame, EPA will honor all of these
requests. After August 2, 2007, a PWS
may request that its schedule be
changed; however, unlike the first 210day period, the PWS will need to
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explain its rationale for the requested
change. Budgetary issues or well
closings are examples of problems that
will be considered legitimate reasons for
schedule changes. A system is subject to
its original assigned sampling schedule
or its modified schedule established
prior to August 2, 2007 via EPA’s
electronic data reporting system, unless
and until it receives notification from
EPA specifying a new schedule.
To help PWSs with scheduling and to
provide additional assurance of
laboratory capacity, the final regulation
contains revised language that:
(1)Changes the monitoring period for
UCMR 2 from July 2007 through June
2010 to January 2008 through December
2010; and (2) extends the two-year
monitoring period for the List 2
Screening Survey contaminants to three
years, such that the Screening Survey
will coincide with the three-year
Assessment Monitoring period of
January 2008 through December 2010.
In addition, because of the logistical
issues associated with sampling for
UCMR 2 (e.g., seasonal operation of
some wells), the final regulation also
contains revised language that extends
the time frame for collecting the second
ground water sample to 5–7 months
following the collection of the first
round of samples. This will allow
systems that have multiple sampling
points to schedule the second sampling
event across the 5–7 month window.
However, for planning purposes, EPA
will preliminarily schedule these
sampling events 6 months apart.
e. Notice regarding applicability or
inability to meet sampling schedule
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i. This Rule
This rule includes system reporting
requirements to ensure communication
between PWSs and EPA regarding rule
applicability and compliance. These
requirements include: reporting changes
in system status or other factors that
affect a system’s requirements under the
rule (e.g., a system believes it does not
meet the applicability criteria for
UCMR); notifying EPA if a system
believes it is subject to UCMR
requirements but has not been notified
by either EPA or the State regarding
requirements; and reporting to EPA if a
system cannot sample according to its
assigned schedule. The final regulation
at § 141.35(c)(5) contains revised
language to clarify that systems
collecting samples from ground water
sources can collect their second set of
samples within the 5–7 months of the
first sampling event.
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ii. Summary of Major Comments
Some commenters suggested that EPA
develop a list of acceptable reasons for
not monitoring from a source to
eliminate the need for systems to notify
EPA. EPA believes that it is impractical
to develop an exhaustive list. It is
important that EPA be notified of any
reason that a scheduled sampling event
will be missed to allow for effective
coordination of compliance assistance
and enforcement actions.
2. Reporting of Required Data Elements
a. This Rule
This rule specifies 15 data elements in
§ 141.35(e), Table 1, to be reported with
UCMR 2 sample test results. In this
table, EPA is providing clarifying
language to the following four data
elements: Water Source Type (data
element #3); Sampling Point
Identification Code (data element #4);
Sampling Point Type Code (data
element #5); and Disinfectant Residual
Type (data element #6). EPA received
comments on Sample Analysis Type
(data element #11) and Sample Event
Code (data element #15) but did not
revise these data elements in this action.
b. Summary of Major Comments
Comments were received questioning
whether systems would be required to
report source water changes that occur
throughout the 12-month monitoring
period or only those that occur between
sampling events. To simplify UCMR 2
reporting, the definition of ‘‘Water
Source Type’’ (data element #3)
contains revised language specifying
that if any percentage of the total water
associated with that sampling point
originates either from surface water or
GWUDI source during the 12-month
monitoring period, then that source
should be reported as ‘‘SW’’ or ‘‘GU’’ as
appropriate. If a sampling point is
served by both a surface water and
GWUDI source during the 12-month
monitoring period, then that source
should be reported as SW (i.e., SW takes
precedence over GU in the hierarchy of
source water reporting). The only time
that a source is to be considered ground
water is if 100 percent of the water
associated with that sampling point is
from a ground water source during the
entire 12-month monitoring period. By
defining a sampling point source over
the entire 12-month monitoring period,
many instances where a system would
otherwise need to report a change in its
source to EPA will be eliminated.
Some commenters indicated that
definitions for Sampling Point
Identification Code (data element #4),
and Sampling Point Type Identification
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381
Code (data element #5), seem
redundant. In response to comments,
the final regulation contains revised
language changing the name of data
element #5 to ‘‘Sampling Point Type
Code’’ and clarifying the definitions of
these two data elements.
Some commenters recommended that
EPA clarify the definition of
‘‘Disinfectant Residual Type’’ (data
element #6) because some systems may
periodically use an alternate
disinfectant. EPA’s intent in the
proposed rule language was that PWSs
would report the type of disinfectant
used at the time of each specific
sampling event. In response to this
comment, the final rule contains revised
language to Table 1 of § 141.35(e) to
clarify this point.
Some commenters expressed concern
that EPA will create inconsistencies in
water system and laboratory databases
by retaining the name ‘‘Sample
Analyses Type’’ from UCMR 1 but
changing the codes associated with it.
EPA revised the codes associated with
this data element (#11) to better reflect
the type of sample collected. The values
that laboratories used previously proved
to be problematic, since laboratories did
not have enough information about the
PWS’s treatment systems or sample
locations to assign the correct sample
analysis type. Instead, EPA proposed
and is finalizing in this rule codes that
will provide EPA with QC information
at the field sample level and with
information about which UCMR field
sample was fortified.
3. Reporting Process
a. Where to Report
This rule specifies in § 141.35(b)(1)
the Web address for information that
must be submitted electronically as:
https://www.epa.gov/safewater/ucmr/
ucmr2/reporting.html. This paragraph of
the final rule also specifies that
supporting documentation can be
submitted to: UCMR Sampling
Coordinator, USEPA, Technical Support
Center, 26 West Martin Luther King
Drive (MS 140), Cincinnati, OH 45268;
or by e-mail at
UCMR_Sampling_Coordinator@epa.gov;
or by fax at (513) 569–7191. EPA did not
receive any comments related to this
aspect of the rule.
b. Electronic Reporting System
i. This Rule
EPA’s electronic data reporting
system—called SDWARS, which can be
accessed on the Web at: https://
www.epa.gov/safewater/ucmr/ucmr2/
reporting.html—is the primary portal for
PWSs and laboratories to submit contact
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and inventory information to EPA. The
UCMR program requires that all
monitoring results and associated data
elements be reported using this system.
There were no changes between the
proposed and final rule language
regarding this data reporting system.
The data review and approval process is
discussed in Section III.J.3.c.
ii. Summary of Major Comments
EPA received several
recommendations to provide more
information and guidance related to
PWS and laboratory use of its electronic
data reporting system. In addition,
several commenters requested that EPA
pre-populate the UCMR 2 database with
contact and inventory information that
was collected under UCMR 1, or that it
be easily accessible through EPA’s
SDWIS database.
EPA is not pre-populating the
SDWARS 2 database with PWS contact
information for two reasons. First, the
data that EPA currently has on file are
several years old and EPA is aware that
many changes in contact information
are necessary. Second, EPA will use a
PWS’s entry of this information into
SDWARS to confirm that the system has
successfully set up its SDWARS
account. However, EPA will upload all
inventory information that it has
available (i.e., PWS identification code;
PWS facility identification code;
sampling point identification code;
sampling point type code; and sampling
location water type). PWSs will be
responsible for verifying, correcting, and
updating inventory information, as
needed. In addition, EPA is finalizing
the specific process for the upload of
monitoring results and will release the
details of the process and upload files
as far ahead of the start of monitoring as
possible.
Some comments were received
expressing concern about the stability of
the UCMR 1/SDWARS 1 database,
claiming that data was lost which
caused unnecessary notices of violation
to be issued. Comments suggested that
reminder letters/notices for compliance
assistance would be more effective.
Other comments were received
suggesting that, to minimize confusion,
PWSs have the option to report using
the process they already use to report to
their States, and States would then
report to EPA.
EPA is not aware of any cases in
which SDWARS lost data. In general,
where data appeared to be lost, closer
review revealed other reasons for the
problem, including various situations
that resulted in data that was not
officially ‘‘approved’’ or data transfer
errors by laboratories that caused
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SDWARS to reject all or parts of files.
When developing UCMR 1 and the
overall UCMR program, EPA was
concerned about the problem of
transcription errors in data reporting.
Therefore, EPA designed SDWARS such
that the originator (i.e., the laboratory
that performed the analysis) was
responsible for entering the data into the
database.
c. Data Review and Approval Process/
Timeline
i. This Rule
This rule requires large systems to
ensure that their laboratory posts the
data in EPA’s electronic data reporting
system (https://www.epa.gov/safewater/
ucmr/ucmr2/reporting.html) within 120
days from the sample collection date.
Large systems then have 60 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 via the EPA
electronic reporting system. If systems
do not take action on the data within 60
days of the laboratory’s posting to the
electronic reporting system, the data
will be considered approved by the
system, and available for EPA review,
and subsequent public release.
Because EPA pays for and organizes
the small system testing program, the
review and approval steps for small
systems differ. Small systems are only
required to record system and sample
location information on the sampling
forms and bottles that are sent to them
by the UCMR Sampling Coordinator.
Procedures for submitting this
information will be specified in the
instructions sent to the system. Small
systems are not required to review
monitoring results, although they will
be given a 60-day opportunity to review
such results prior to their results being
posted to the publicly available Web
site.
ii. Summary of Major Comments
Several commenters expressed that
PWSs could not be held responsible for
laboratory compliance with the UCMR 2
reporting requirements. Section
141.35(c)(6)(ii) specifies that PWSs must
ensure that their laboratories post the
required data to the electronic database
within 120 days of sampling. PWSs
have the responsibility to require that
their laboratory meets this reporting
deadline and PWSs are ultimately
responsible for ensuring the quality of
their data.
Regarding compliance with review
and approval timelines, commenters
also were concerned that unnecessary
enforcement notices were issued during
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UCMR 1 often because PWSs had not
correctly processed and approved data
through SDWARS. Several commenters
recommended that reminder notices
would help to ensure reporting
compliance during UCMR 2 and reduce
the need for enforcement actions. Other
commenters were concerned about
laboratory capacity and the ability of a
limited number of approved laboratories
to successfully conduct analyses and
reporting within the required time
frames.
EPA is currently in the final stages of
developing the SDWARS electronic data
entry system for entry of UCMR 2
monitoring results and is including an
automatic e-mail system that will alert
PWSs that data was entered by the
laboratory, thereby reminding PWSs
that they need to review and approve
their monitoring data.
4. Cross-Media Reporting and Data
Availability
a. Cross-Media Electronic Reporting
The reporting required under this
final rule is consistent with the
requirements of the October 13, 2005,
regulation, ‘‘Cross-Media Electronic
Reporting’’ (70 FR 59847, (USEPA,
2005b)).
b. Data Availability
The data collected through the UCMR
program is being stored in NCOD to
facilitate analysis and review of
contaminant occurrence; to guide the
conduct of the CCL process; and to
support the Administrator’s
determination to regulate a contaminant
in the interest of protecting public
health, as required under SDWA Section
1412(b)(1). Results of the UCMR 1
monitoring can be viewed by the public
at EPA’s UCMR Web site: https://
www.epa.gov/safewater/ucmr/
data.html.
K. What Constitutes a Violation Under
UCMR 2?
Under this rule, EPA will finalize the
definitions for monitoring and reporting
violations as proposed. A monitoring
violation under UCMR 2 is defined as:
‘‘Any failure to monitor in accordance
with §§ 141.40(a)(3)–(5) is a monitoring
violation.’’ A reporting violation is
defined as: ‘‘Any failure to report in
accordance with § 141.35 is a reporting
violation.’’ EPA did not receive any
comments related to these violation
definitions.
L. Technical Correction Rule Changes in
This Rule
This rule includes two technical
corrections pertaining to: Aldicarb
monitoring and State primacy.
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1. Changes Pertaining to Aldicarb
Monitoring
IV. State and Tribal Participation
When EPA published ‘‘Revisions to
the Unregulated Contaminant
Monitoring Regulation for Public Water
Systems; Final Rule,’’ on September 17,
1999 (64 FR 50556, (USEPA, 1999)), two
references to § 141.40 in § 141.24
became obsolete, but were not corrected
in the 1999 rule. EPA is correcting this
technical error by revising the
references to requirements for
monitoring for aldicarb, aldicarb
sulfone, and aldicarb sulfoxide in
§ 141.24(h) and § 141.24(h)(7)(v). EPA
suspended monitoring for these
regulated contaminants in a 1992
Federal Register notice (57 FR 22178,
May 27, 1992 (USEPA, 1992)), and there
are no monitoring requirements for
these contaminants under UCMR.
1. This Rule
Under UCMR 2, States may continue
to have a role in rule implementation
through Partnership Agreements (PAs).
Because specific activities for individual
States are identified and established
through the PAs, not through rule
language, this rule does not contain
reference to PAs.
A. Partnership Agreements
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2. Changes Pertaining to State Primacy
Section 553 of the Administrative
Procedure Act, 5 U.S.C. 553(b)(B),
provides that, when an agency for good
cause finds that notice and public
procedure are impracticable,
unnecessary or contrary to the public
interest, the agency may issue a rule
without providing prior notice and an
opportunity for public comment. In
today’s final rule, EPA is removing the
reference to § 141.40 in § 142.16(e), a
portion in the Code of Federal
Regulations (CFR) that enumerates the
sections of the CRF subject to State
primacy. The reference was first
removed on September 17, 1999 (64 FR
50556, (USEPA, 1999)), when EPA
published ‘‘Revisions to the
Unregulated Contaminant Monitoring
Regulation for Public Water Systems;
Final Rule.’’ However, in EPA’s
subsequent publication of the ‘‘Arsenic
and Clarifications to Compliance and
New Source Contaminants Monitoring
Final Rule’’ (66 FR 6975, January 22,
2001, (USEPA, 2001b)), the Agency
inadvertently reinserted the reference to
§ 141.40 in § 142.16(e). EPA has
determined that there is good cause for
making this rule change final without
prior proposal and opportunity for
comment because removal of this
reference was the product of a prior
notice-and-comment rulemaking, (see
64 FR 50556, (USEPA, 1999)) and
because the reference to UCMR
monitoring is erroneous and no longer
has any substantive effect. Thus, notice
and public procedure are unnecessary.
EPA finds that this constitutes ‘‘good
cause’’ under 5 U.S.C. 553(b)(B). For the
same reasons, EPA is making this rule
change effective upon publication.
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2. Summary of Major Comments
Comments received regarding State
participation in UCMR 2
included:Recommendations that nonpartnering States have an opportunity to
review State Monitoring Plans; concerns
regarding State resources to help
implement UCMR 2; and the need for
more guidance from EPA regarding PAs,
including the need for a template for the
sampling protocols for States to use as
the basis for their water system
notification. EPA sent the draft State
Monitoring Plans to all States prior to
the negotiation of PAs. All States that
agreed to partner with EPA were asked
to review and provide any needed
revisions to the draft plan. Each State
could agree to accept additional
responsibilities as documented through
each State’s final PA with EPA. In
addition, EPA will provide States with
guidance and templates for small system
instructions.
B. Governors’ Petition and State-Wide
Waivers
This rule retains the UCMR 1
language that, consistent with SDWA,
allows a minimum of seven State
Governors to petition EPA to add
contaminants to the UCMR Contaminant
list. This rule also retains the UCMR 1
language that allows States to waive
monitoring requirements with EPA
approval and under very limited
conditions. EPA did not receive any
comments on either of these topics.
V. Cost and Benefits of This Rule
In this rule, EPA finalized a new set
of contaminants for monitoring in the
second five-year UCMR cycle of 2007—
2011. UCMR 2 Assessment Monitoring
(for List 1 contaminants) will be
conducted from January 2008 through
December 2010 by 800 systems serving
10,000 or fewer, and by all systems
serving more than 10,000 people. The
Screening Survey for List 2
contaminants will also be conducted
from January 2008 through December
2010 by 800 systems serving 100,000 or
fewer, and all systems serving more
than 100,000 (approximately 400
systems). Small systems (those serving
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383
10,000 or fewer people) will not be
subject to more than one component of
UCMR 2 monitoring. For cost estimation
purposes, EPA assumes that one-third of
systems will monitor during each of the
three monitoring years (2008–2010).
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 will 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 this rule, EPA specified five
analytical methods to monitor for 25
new UCMR contaminants. Estimated
system and EPA costs are based on the
projected analytical costs for these
methods. With the exception of Method
525.2, these methods are comparatively
new and will not coincide with other
compliance monitoring (e.g., no cost
savings for coincident monitoring can
be realized). Laboratory analysis and
shipping of samples account for
approximately 71 percent of the
national cost for UCMR 2
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
cost of laboratory analysis. Under
UCMR 2, surface water (and GWUDI)
sampling points will be monitored four
times during the applicable year of
monitoring, and ground water sampling
points will be monitored twice during
the applicable year of monitoring.
Screening Survey systems that are
required to monitor for DBPs will be
required to sample for nitrosamines at
one distribution system sampling point
per treatment plant (i.e., at the DSMRT),
as well as their EPTDS sampling
locations.
Following publication of the proposed
rule, and EPA’s initial cost and burden
estimates, EPA received several costrelated public comments. Several public
commenters felt that EPA’s estimates of
cost and burden (e.g., laboratory,
shipping fees and estimated labor
burden) to PWSs were too low.
During the proposed rule and
Information Collection Requirement
(ICR) development, EPA estimated
laboratory fees based on consultations
with several national drinking water
laboratories and based on costs of
similar analytical methods. In response
to comments, EPA revisited the
estimates of UCMR 2 method pricing.
EPA approached three additional
national drinking water laboratories
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(different than those consulted
previously) and requested pricing
estimates for UCMR 2 methods. EPA
averaged the pricing estimates from the
laboratories that were consulted into the
cost estimates. EPA also revisited key
shipping company pricing lists to
ensure that shipping cost assumptions
were as accurate as possible.
With respect to per system burden
estimates, EPA notes that all burden
estimates represent average burden
hours, which include surface water
systems that may have very few
sampling points, and thus lower
sampling burden, as well as those
systems with higher numbers of
sampling points that would therefore
have greater sampling activity labor
burden. Moreover, a system’s burden is
primarily incurred during its one year of
required UCMR monitoring (between
January 2008 and December 2010).
However, in compliance with the
requirements of the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.),
these cost and burden estimates are
presented as an average over the
applicable three-year ICR period (2007–
2009). Small systems (those serving
10,000 or fewer people) will have the
lowest burden not only because of the
relative smaller size of their
infrastructure, but also because these
systems will receive a great deal of
direct assistance from EPA and/or their
State.
EPA estimates of laboratory fees are
based on the average cost determined
through consultations with national
drinking water laboratories, unit costs
are as follows:
Assessment Monitoring (List 1):
EPA Method 527 (for 7 contaminants) ............................
EPA Method 529 (for 3 contaminants) ............................
$220
Total List 1 .......................
435
Screening Survey (List 2):
EPA Method 521 (for 6 contaminants) ............................
EPA Method 535 (for 6 contaminants) ............................
EPA Method 525.2 (for 3 contaminants) ............................
Total List 2 .......................
215
310
370
190
870
Shipping is 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 15-pound package overnight,
plus a ground shipment cost of the
empty package which is sent to the
PWSs prior to their required sampling.
In preparing the UCMR 2 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 will incur
only labor costs associated with UCMR
2 implementation. State costs were
estimated using the relevant modules of
the State Resource Model that was
recently 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 1.
Because State participation is
determined through the PAs, level of
effort will vary across States and depend
on their individual agreements with
EPA.
Over the UCMR 2 cycle of 2007–2011,
EPA estimates that nationwide, the
average annual cost of UCMR 2 is
approximately $8.87 million. These
total estimated annual costs and total
estimated costs (labor and non-labor) are
incurred as follows:
Average
annual cost for
all respondents
(2007–2011)
Respondent
Small Systems serving 25—10,000, including labor only (non-labor costs are paid for by EPA) .........................
Large Systems serving 10,001—100,000, including labor and non-labor costs ....................................................
Large Systems serving 100,001 and greater, including labor and non-labor costs ...............................................
States, including labor costs related to implementation coordination .....................................................................
EPA, including labor for implementation coordination and non-labor for small system testing .............................
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National Total ...................................................................................................................................................
Additional details regarding EPA’s
cost assumptions and estimates can be
found in the ICR Number 2192.01
amendment prepared for the final rule
(OMB number 2040–0270), which
presents estimated cost and burden for
the 2007–2009 monitoring period.
Estimates of costs over the entire second
five-year UCMR cycle of 2007–2011 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 rule, which includes this
ICR, under Docket ID Number OW–
2004–0001.
VI. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review
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.
B. Paperwork Reduction Act
OMB has approved the information
collection requirements contained in
this rule under the provisions of the
Paperwork Reduction Act, 44 U.S.C.
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$0.06
3.84
1.91
0.49
2.57
Total
estimated
costs for all respondents
(2007–2011)
m
m
m
m
m
$0.30
19.20
9.55
2.45
12.85
8.87 m
44.35
3501 et seq. and has assigned OMB
control number 2040–0270.
The information to be collected under
this rule fulfills the statutory
requirements of Section 1445(a)(2) of
SDWA, as amended in 1996. The data
to be collected will describe the source
of the water, location, and test results
for samples taken from PWSs. The
concentrations of any identified UCMR
contaminants will be evaluated with
respect to health effects and those
contaminants will be considered for
future regulation accordingly. Reporting
is mandatory. The data are not subject
to confidentiality protection.
The annual burden and cost estimates
described below are for the
implementation assumptions described
in Section V, Cost and Benefits of the
Rule, of this action. Respondents to the
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UCMR 2 will include 1,280 small water
systems (those serving 10,000 or fewer
people; 800 for Assessment Monitoring
and 480 for Screening Survey
monitoring), the 3,633 large PWSs
(those serving more than 10,000 people),
and the 56 States and primacy agencies
(4,969 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. Cost estimates assumes that
most Assessment Monitoring and
Screening Survey systems will conduct
sampling evenly across the January
2008–December 2010 monitoring period
(i.e., one-third in each of the three
consecutive 12-month periods). Because
the applicable ICR period is 2007–2009,
only two years of core monitoring
activity are captured in the ICR
estimates. Some rule preparation,
including reporting of contact and
inventory information, will occur
during 2007.
Small systems (those serving 10,000
or fewer) that are selected for UCMR 2
monitoring will sample an average of
1.8 times per system (i.e., number of
responses per system) across the threeyear ICR period of 2007–2009. The
average burden per response for small
systems is estimated to be 3.5 hours.
Large systems serving 10,001 to 100,000
people and large systems serving more
than 100,000 people will sample and
report an average of 2.0 and 2.4 times
per system, respectively, across the
three-year ICR period of 2007–2009. The
average burdens per response for these
two categories of large systems are
estimated to be 9.8 and 15.2 hours,
respectively. The larger burden per
response for the largest systems reflects
the fact that these systems typically
have more sampling locations. 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
203.2 hours. In aggregate, during the ICR
period of 2007–2009, the average
response (including responses from both
systems and States) is associated with a
burden of 12.1 hours, with a labor plus
non-labor cost of $2,170 per response.
The annual average per respondent
burden hours and costs for the ICR
period of 2007–2009 are: small
systems—2.1 hour burden at $57 for
labor; large systems serving 10,001 to
100,000—6.6 hours at $197 for labor,
and $1,651 for analytical costs; large
systems serving more than 100,000—
12.1 hours at $431 for labor, and $4,840
for analytical costs; and States—203.2
hours at $11,107 for labor. Annual
average burden and cost per respondent
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(including both systems and States) is
estimated to be 8.1 hours, with a labor
plus non-labor cost of $1,456 per
respondent. Note that small systems do
not pay for testing costs, so they only
incur labor costs. The total annual
burden for the ICR reporting period of
2007–2009 is 40,386 hours (with a labor
cost of $1.51 million); the total annual
analytical cost is $5.73 million.
The Agency estimates the annual
burden to EPA for UCMR program
activities during the ICR years of 2007–
2009 to be approximately 9,533 hours,
at an annual labor cost of $0.66 million.
EPA’s annual non-labor costs are
estimated to be $2.3 million. EPA’s nonlabor costs are primarily attributed to
the cost of sample analysis for small
systems (analysis is just under 90
percent of non-labor cost).
Burden means the total time, effort, or
financial resources expended by persons
to generate, maintain, retain, or disclose
or provide information to or for a
Federal agency. This includes the time
needed to review instructions; develop,
acquire, install, and utilize technology
and systems for the purposes of
collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements; train personnel to be able
to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
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. In
addition, EPA is amending the table in
40 CFR part 9 of currently approved
OMB control numbers for various
regulations to list the regulatory
citations for the information
requirements contained in this final
rule.
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
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385
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)
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 this final 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 7605, 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 44511, August 19,
1998 (USEPA, 1998c)). As stated in that
Final Rule, the alternative definition is
applied to this regulation as well.
After considering the economic
impacts of this final 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 final rule are a subset of small
community and non-transient noncommunity PWSs serving 10,000 or
fewer people. We have determined that
the 1,280 small PWSs required to
participate in either the Assessment
Monitoring or Screening Survey
components of UCMR 2 will experience
an average cost of $43 per year; the
remainder of small systems are not
subject to this final rule.
Although this final 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. As
required by SDWA, the Agency
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specifically structured the rule to avoid
significantly affecting small entities by
assuming all costs for laboratory
analyses, shipping, and QC for small
entities. As a result, EPA incurs the
entirety of the non-labor costs
associated with UCMR 2 small system
monitoring. With its authority to use
monies from the Drinking Water State
Revolving Fund (DWSRF) for the
purposes of implementing this
provision of SDWA, EPA has set aside
$2.0 million each year to apply towards
these costs. Small system costs are
limited to the additional labor required
for reading about their requirements,
monitoring, reporting, and
recordkeeping. The estimated average
annual burden across the five-year
UCMR 2 cycle of 2007–2011 is
estimated to be 1.5 hours at $43 per
small system. These costs for small
systems are discussed in Section 6(a)(i)
of the ICR document, available on the
EPA public docket for this rule, under
Docket ID Number OW–2004–0001 at
https://www.regulations.gov.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Public
Law 104–4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State, local,
and Tribal governments and the private
sector. Under section 202 of the UMRA,
EPA generally must prepare a written
statement, including a cost-benefit
analysis, for proposed and final rules
with ‘‘Federal mandates’’ that may
result in expenditures to State, local,
and Tribal governments, in the
aggregate, or to the private sector, of
$100 million or more in any one year.
Before promulgating an EPA rule for
which a written statement is needed,
section 205 of the UMRA generally
requires EPA to identify and consider a
reasonable number of regulatory
alternatives and adopt the least costly,
most cost-effective, or least burdensome
alternative that achieves the objectives
of the rule. The provisions of section
205 do not apply when they are
inconsistent with applicable law.
Moreover, section 205 allows EPA to
adopt an alternative other than the least
costly, most cost-effective, or least
burdensome alternative if the
Administrator publishes with the final
rule an explanation of why that
alternative was not adopted. Before EPA
establishes any regulatory requirements
that may significantly or uniquely affect
small governments, including Tribal
governments, it must have developed
under section 203 of the UMRA a small
government agency plan. The plan must
provide for notifying potentially
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affected small governments, enabling
officials of affected small governments
to have meaningful and timely input in
the development of EPA regulatory
proposals with significant Federal
intergovernmental mandates, and
informing, educating, and advising
small governments on compliance with
the regulatory requirements.
EPA has determined that 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 this final rule (across the
UCMR 2 cycle of 2007–2011), for State,
local, and Tribal governments and the
private sector, are estimated to be $8.86
million, of which EPA will pay $2.57
million, or approximately 29 percent.
Thus, this rule is not subject to the
requirements of sections 202 and 205 of
the UMRA.
EPA has determined that this rule
contains no regulatory requirements that
might significantly or uniquely affect
small governments. The Agency will
pay for the reasonable costs of sample
analysis for the small PWSs required to
monitor for unregulated contaminants
under this final rule, including those
owned and operated by small
governments. The only costs that small
systems will incur are those attributed
to collecting the UCMR samples and
packing them for shipping to the
laboratory (EPA will pay for shipping).
These costs are minimal. They are not
significant or unique. Thus, this rule is
not subject to the requirements of
UMRA section 203.
E. Executive Order 13132: Federalism
Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999), requires EPA to develop an
accountable process to ensure
‘‘meaningful and timely input by State
and local officials in the development of
regulatory policies that have federalism
implications.’’ ‘‘Policies that have
federalism implications’’ is defined in
the Executive Order to include
regulations that have ‘‘substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’
This final 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
responsibilities among the various
levels of government, as specified in
Executive Order 13132.
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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 rule. In the spirit of Executive
Order 13132, and consistent with EPA
policy to promote communications
between EPA and State and local
governments, EPA specifically solicited
comment on the proposed rule from
State and local officials.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
Executive Order 13175, entitled
‘‘Consultation and Coordination with
Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), requires EPA
to develop an accountable process to
ensure ‘‘meaningful and timely input by
tribal officials in the development of
regulatory policies that have tribal
implications.’’
This final rule does not have Tribal
implications, as specified in Executive
Order 13175. It will neither impose
substantial direct compliance costs on
Tribal governments, nor preempt Tribal
law. This final rule 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 part
of such sample. EPA estimates the
average annual cost over the five-year
rule period to be $43, based on the labor
associated with collecting a sample and
preparing it for shipping. 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, 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
sample selection process. EPA
developed the sample frame for Tribal
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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 that are 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.
EPA also held a public stakeholder
meeting on October 23, 2003. This
meeting was announced to the public in
a Federal Register notice dated
September 11, 2003. Prior to the
meeting, background materials and rule
development information were sent to
specific stakeholders, including
representatives from the IHS and the
Native American Water Association.
As described previously, this final
rule requires monitoring by all large
systems serving more than 10,000
people. Ten Tribal water systems have
been identified as large systems. EPA
estimates the average annual cost for
each large system over the five-year rule
period to be less than $1,200. Such cost
is based on a labor component
(associated with the collection of
samples) and a non-labor component
(associated with shipping and
laboratory fees).
This final rule, addressing the second
UCMR period, maintains the basic
program design of the original UCMR,
building upon the structure established
by the original rule for this cyclical
program. The primary changes include:
(1) Improving the design of the
Screening Survey for List 2
contaminants to increase the statistical
strength of the sampling results; (2)
updating the lists of contaminants to be
monitored and the analytical methods
approved to conduct that monitoring;
(3) revising the ‘‘data elements’’
required to be reported; and (4) revising
the implementation of the monitoring
program to reflect ‘‘lessons learned’’
during UCMR 1.
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
Executive Order 13045, ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
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April 23, 1997), applies to any rule that:
(1) is determined to be ‘‘economically
significant’’ as defined under Executive
Order 12866, and (2) concerns an
environmental health or safety risk that
EPA has reason to believe may have a
disproportionate effect on children. If
the regulatory action meets both criteria,
the Agency must evaluate the
environmental health or safety effects of
the planned rule on children, and
explain why the planned regulation is
preferable to other potentially effective
and reasonably feasible alternatives
considered by the Agency.
This final rule is not subject to the
Executive Order because it is not
economically significant as defined in
Executive Order 12866, and because the
Agency does not have reason to believe
the environmental health or safety risks
addressed by this action present a
disproportionate risk to children.
This final rule is part of the Agency’s
overall strategy for deciding whether to
regulate the contaminants identified on
the CCL (63 FR 10274, March 2, 1998
(USEPA, 1998b)). The purpose of this
final rule is to ensure that EPA has data
on the occurrence of contaminants on
the CCL where those data are lacking.
EPA is also taking steps to ensure that
the Agency will have data on the health
effects of these contaminants on
children through its research program.
The Agency will use these data (both
contaminant occurrence and health
effects) to help decide whether or not to
regulate any of these contaminants.
However, given EPA’s interest in
protecting children’s health, as part of
the original provisions in UCMR 1,
allowing State Governors to petition
EPA to add contaminants to the UCMR
Contaminant List, EPA requests
Governors to include any information
that might be available regarding
disproportional risks to the health or
safety of children. Such information
will help inform EPA’s decisionmaking
regarding the UCMR contaminant list.
H. Executive Order 13211: Actions That
Significantly Affect Energy Supply,
Distribution, or Use
This rule is not a ‘‘significant energy
action’’ as defined in Executive Order
13211, ‘‘Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use’’ (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.
The frequency of required monitoring
and testing in this rulemaking does not
rise to the level of significant cost to
drinking water utilities. Therefore, we
have concluded that this rule is not
likely to have any adverse energy costs.
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I. National Technology Transfer and
Advancement Act
As noted in the proposed rule,
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (‘‘NTTAA’’), Public Law No.
104–113, 12(d) (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. The NTTAA directs EPA to
provide Congress, through OMB,
explanations when the Agency decides
not to use available and applicable
voluntary consensus standards.
This rulemaking involves technical
standards. Therefore, the Agency
conducted a search to identify
potentially applicable voluntary
consensus standards. However, we
identified no such standards, and none
were brought to our attention in
comments. Therefore, EPA has decided
to use the methods development that
the Agency conducted (described in
Section III.C), which was necessary to
establish acceptable methods for the
determination of these UCMR 2
parameters.
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order 12898, ‘‘Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations’’ (February 11,
1994), focuses Federal attention on the
environmental and human health
conditions of minority and low-income
populations with the goal of achieving
environmental protection for all
communities.
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. Using a
statistically-derived set of systems for
the nationally representative sample
that is population-weighted within each
system size category in each State, the
final rule ensures that no group within
the population is under-represented.
K. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
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Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A Major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2). This rule
will be effective February 5, 2007.
VII. 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
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 UCMR, please see the discussion in
the September 1999 UCMR Final Rule
Federal Register at 64 FR 50556
(USEPA, 1999).
Specific to the development of UCMR
2, a stakeholder meeting was held on
October 29, 2003, in Washington, DC.
There were 25 attendees, representing
State agencies, Federal agencies,
laboratories, PWSs, and drinking water
associations. The topics of presentations
and discussions included: Rationale for
selecting a new list of proposed
contaminants; analytical methods to be
used in measuring these contaminants;
sampling design, particularly for the
Screening Survey monitoring; procedure
for determining LCMRLs; validation of
laboratory performance at or below the
MRL; revisions to data elements; and
other proposed revisions based on
lessons learned during implementation
of UCMR 1.
In addition to public involvement
during program and proposed rule
development, EPA received comments
from 36 public commenters. EPA’s
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responses to these comments are
summarized in Sections III, IV and V of
this preamble. EPA has compiled a
document containing all public
comments and EPA’s responses entitled:
‘‘UCMR 2 Categorized Public
Comments,’’ (USEPA, 2006b) which can
be obtained by going to https://
www.regulations.gov and searching for
Docket ID No. OW–2004–0001 under
the advanced search tab.
VIII. References
Association of State Drinking Water
Administrators (ASDWA). 2003. Public
Health Protection Threatened by Inadequate
Resources for State Drinking Water
Programs—An Analysis of State Drinking
Water Programs Resources, Needs, and
Barriers. April 2003. Available on the
Internet at: https://www.asdwa.org/.
Darnerud, P.O., G.S. Erickson, T.
Johannesson, P.B. Larson, and M.
Viluksela. 2001. Polybrominated
Diphenyl Ethers: Occurrence, Dietary
Exposure, and Toxicology.
Environmental Health Perspectives
Supplements. Vol. 109, No. S1. Available
on the Internet at: https://
ehp.niehs.nih.gov/members/2001/suppl1/49–68darnerud/darnerud-full.html. de
Wit, C.A. February 2002. An overview of
brominated flame retardants in the
environment. Chemosphere. 46(5):583–
624.
Hites, R. 2004. Polybrominated Diphenyl
Ethers in the Environment and in People:
A Meta-Analysis of Concentration.
Environmental Science and Technology.
Vol. 38, No. 4. pp. 945–956.
McDonald, T.A. February 2002. A
perspective on the potential health risks
of PBDEs. Chemosphere. 46(5):745–55.
Meerts, I.A., Letcher, R.J., Hoving, S., Marsh,
G., Bergman, A., Lemmen, J.G., van der
Burg, B., and A. Brouwer. April 2001. In
vitro estrogenicity of polybrominated
diphenyl ethers, hydroxylated PDBEs,
and polybrominated bisphenol A
compounds. Environmental Health
Perspective. 109(4):399–407.
Stoker, T.E., Cooper, R.L., Lambright, C.S.,
Wilson, V.S., Furr, J., and L.E. Gray.
August 2005. In vivo and in vitro antiandrogenic effects of DE–71, a
commercial polybrominated diphenyl
ether (PBDE) mixture. Toxicology and
Applied Pharmacology. 207(1):78–88.
United States Environmental Protection
Agency (USEPA). 1992. National Primary
Drinking Water Regulations; Aldicarb,
Aldicarb Sulfoxide, and Aldicarb
Sulfone; Notice of postponement of
certain provisions of final rule. Federal
Register. Vol. 57, No. 102. p. 22178, May
27, 1992.
USEPA. 1995. Method 525.2—Determination
of Organic Compounds in Drinking
Water by Liquid-Solid Extraction and
Capillary Column Gas Chromatography/
Mass Spectrometry. Revision 2.0, 1995 is
available on the Internet at: https://
www.NEMI.gov.
USEPA. 1998a. National Primary Drinking
Water Regulations: Consumer
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Confidence Reports; Final Rule. Federal
Register. Vol. 63, No. 30. p. 7605,
February 13, 1998.
USEPA. 1998b. Announcement of the
Drinking Water Contaminant Candidate
List; Notice. Federal Register. Vol. 63,
No. 40. p. 10274, March 2, 1998.
USEPA. 1998c. National Primary Drinking
Water Regulations: Consumer
Confidence Reports. Federal Register.
Vol. 63, No. 160. p. 44511, 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. 2000. Unregulated Contaminant
Monitoring Regulation for Public Water
Systems: Analytical Methods for
Perchlorate and Acetochlor;
Announcement of Laboratory Approval
and Performance Testing (PT) Program
for the Analysis of Perchlorate; Final
Rule and Proposed Rule. Federal
Register. Vol. 65, No. 42. p. 11372,
March 2, 2000.
USEPA. 2001a. Unregulated Contaminant
Monitoring Regulation for Public Water
Systems; Analytical Methods for List 2
Contaminants; Clarifications to the
Unregulated Contaminant Monitoring
Regulation. Federal Register. Vol. 66,
No. 8. p. 2273, January 11, 2001.
USEPA. 2001b. National Primary Drinking
Water Regulations; Arsenic and
Clarifications to Compliance and New
Source Contaminants Monitoring.
Federal Register. Vol. 66, No. 14. p.
6975, January 22, 2001.
USEPA. 2002a. EPA Method 529—
Determination of Explosives and Related
Compounds in Drinking Water by Solid
Phase Extraction and Capillary Column
Gas Chromatography/Mass Spectrometry
(GC/MS). Available on the Internet at:
https://www.epa.gov/nerlcwww/
ordmeth.htm.
USEPA. 2002b. Unregulated Contaminant
Monitoring Regulation: Approval of
Analytical Method for Aeromonas;
National Primary and Secondary
Drinking Water Regulations: Approval of
Analytical Methods for Chemical and
Microbiological Contaminants. Federal
Register. Vol. 67, No. 209. p. 65888,
October 29, 2002.
USEPA. 2004a. EPA Method 521—
Determination of Nitrosamines in
Drinking Water by Solid Phase
Extraction and Capillary Column Gas
Chromatography with Large Volume
Injection and Chemical Ionization
Tandem Mass Spectrometry (MS/MS).
Revision 1.0, April 2005 is available on
the Internet at: https://www.epa.gov/
nerlcwww/ordmeth.htm.
USEPA. 2004b. EPA Method 527—
Determination of Selected Pesticides and
Flame Retardants in Drinking Water by
Solid Phase Extraction and Capillary
Column Gas Chromatography/Mass
Spectrometry (GC/MS). EPA 815–R–05–
005. April 2005. Available on the
Internet at: https://www.epa.gov/
safewater/methods/sourcalt.html.
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USEPA. 2004c. EPA Method 535,
Measurement of Chloroacetanilide and
Other Acetamide Herbicide Degradates
in Drinking Water by Solid Phase
Extraction and Liquid Chromatography/
Tandem Mass Spectrometry (LC/MS/
MS). Version 1.1, April 2005 is available
on the Internet at: https://www.epa.gov/
nerlcwww/ordmeth.htm.
USEPA. 2004d. UCMR 2 Laboratory
Approval Manual. Available upon
request as detailed at: https://
www.epa.gov/safewater/ucmr/ucmr2/
index.html.
USEPA. 2005a. Unregulated Contaminant
Monitoring Regulation (UCMR) for
Public Water Systems Revisions;
Proposed Rule. Federal Register. Vol. 70,
No. 161. p. 49093, August 22, 2005.
USEPA. 2005b. Cross Media Electronic
Reporting. Federal Register. Vol. 70, No.
197. p. 59847, October 13, 2005.
USEPA. 2006a. National Primary Drinking
Water Regulations: Stage 2 Disinfectants
and Disinfection Byproducts Rule; Final
Rule. Federal Register. Vol. 71 No. 2. p.
388, January 4, 2006.
USEPA. 2006b. UCMR 2 Categorized Public
Comments. Available on the Internet at:
https://www.epa.gov/safewater/ucmr/
ucmr2/.
List of Subjects
40 CFR Part 9
Reporting and recordkeeping
requirements.
40 CFR Part 141
Environmental protection, Chemicals,
Incorporation by reference, Indianslands, Intergovernmental relations,
Radiation protection, Reporting and
recordkeeping requirements, Water
supply.
40 CFR Part 142
Analytical methods, Chemicals,
Environmental Protection,
Administrative practice and procedure,
Chemicals, Indians-lands, Radiation
Protection, Reporting and recordkeeping
requirements, Water supply.
Dated: December 20, 2006.
Stephen L. Johnson,
Administrator.
For the reasons set out in the
preamble, title 40, chapter 1 of the Code
of Federal Regulations is amended as
follows:
I
PART 9—OMB APPROVALS UNDER
THE PAPERWORK REDUCTION ACT
1. The authority citation for part 9
continues to read as follows:
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I
Authority: 7 U.S.C. 135 et seq., 136–136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345(d) and
(e); 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971–1975 Comp. p. 973; 42 U.S.C. 241,
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242b, 243, 246, 300f, 300g, 300g–1, 300g–2,
300g–3, 300g–4, 300g–5, 300g–6, 300j–1,
300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,
6901–6992k, 7401–7671q, 7542, 9601–9657,
11023, 11048.
389
§ 141.35 Reporting for unregulated
contaminant monitoring results.
(a) General applicability. This section
applies to any owner or operator of a
public water system (PWS) required to
monitor for unregulated contaminants
I 2. Section 9.1 is amended by revising
under § 141.40(a); such owner or
the entries for ‘‘141.35’’ and ‘‘141.40’’ to operator is referred to as ‘‘you.’’ This
read as follows:
section specifies the information that
§ 9.1 OMB approvals under the Paperwork must be reported to EPA prior to the
commencement of monitoring and
Reduction Act.
describes the process for reporting
*
*
*
*
*
monitoring results to EPA. For the
purposes of this section, PWS
OMB Control
40 CFR Citation
‘‘population served’’ includes the sum
No.
of the retail population served directly
by the PWS plus the population served
*
*
*
*
*
by any consecutive system(s) receiving
National Primary Drinking Water Regulations
all or part of its finished water from that
PWS. For purposes of this section, the
*
*
*
*
*
term ‘‘finished’’ means water that is
141.35 ...................................
2040–0270 introduced into the distribution system
141.40 ...................................
2040–0270
of a PWS and is intended for
distribution and consumption without
*
*
*
*
*
further treatment, except the treatment
necessary to maintain water quality in
PART 141—NATIONAL PRIMARY
the distribution system (e.g., booster
DRINKING WATER REGULATIONS
disinfection, addition of corrosion
control chemicals). For purposes of this
I 3. The authority citation for part 141
section, the term ‘‘State’’ refers to the
continues to read as follows:
State or Tribal government entity that
Authority: 42 U.S.C. 300f, 300g–1, 300g–2,
has jurisdiction over your PWS even if
300g–3, 300g–4, 300g–5, 300g–6, 300j–4,
that government does not have primary
300j–9, and 300j–11.
enforcement responsibility for PWSs
under the Safe Drinking Water Act. For
Subpart C—[Amended]
purposes of this section, the term ‘‘PWS
Official’’ refers to the person at your
I 4. Section 141.24 is amended by
PWS who is able to function as the
revising paragraph (h) introductory text, official spokesperson for the system’s
removing footnote 7 of paragraph (h)
Unregulated Contaminant Monitoring
introductory text, and by revising
Regulation (UCMR) activities; and the
paragraph (h)(7)(v) to read as follows:
term ‘‘PWS Technical Contact’’ refers to
§ 141.24 Organic chemicals, sampling and the person at your PWS who is
responsible for the technical aspects of
analytical requirements.
your UCMR activities, such as details
*
*
*
*
*
concerning sampling and reporting.
(h) Analysis of the contaminants
(b) Reporting by all systems. You must
listed in § 141.61(c) for the purposes of
meet the reporting requirements of this
determining compliance with the
paragraph if you meet the applicability
maximum contaminant level shall be
criteria in § 141.40(a)(2).
conducted as follows, with the
(1) Where to submit UCMR reporting
exception that no monitoring is required requirement information. Some of your
for aldicarb, aldicarb sulfoxide or
reporting requirements are to be
aldicarb sulfone:
fulfilled electronically, and others by
mail. Information that must be
*
*
*
*
*
submitted using EPA’s electronic data
(7) * * *
reporting system must be submitted
(v) If the monitoring results in
through: https://www.epa.gov/safewater/
detection of one or more of certain
ucmr/ucmr2/reporting.html.
related contaminants (heptachlor and
Documentation that is required to be
heptachlor epoxide), then subsequent
mailed can be submitted either: To
monitoring shall analyze for all related
UCMR Sampling Coordinator, USEPA,
contaminants.
Technical Support Center, 26 West
Martin Luther King Drive (MS 140),
*
*
*
*
*
Cincinnati, OH 45268; or by e-mail at
Subpart D—[Amended]
UCMR_Sampling_Coordinator@epa.gov;
or by fax at (513) 569–7191. In addition,
I 5. Section 141.35 is revised to read as
you must notify the public of the
follows:
availability of unregulated contaminant
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Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
monitoring data as provided in Subpart
Q (Public Notification) of this part (40
CFR 141.207). Community Water
Systems that detect unregulated
contaminants under this monitoring
must also address such detections as
part of their Consumer Confidence
Reports, as provided in Subpart O of
this part (40 CFR 141.151).
(2) Contacting EPA if your system
does not meet applicability criteria or
has a status change. 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)(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. The letter must be from your
PWS Official and must include an
explanation as to why the UCMR
requirements are not applicable to your
PWS, or have changed for your PWS,
along with the appropriate contact
information. EPA will make an
applicability determination based on
your letter and in consultation with the
State when necessary. You are subject to
UCMR requirements unless and until
you receive a letter from EPA agreeing
that you do not meet the applicability
criteria.
(c) Reporting by large systems. If you
serve a population of more than 10,000
people, and meet the applicability
criteria in § 141.40(a)(2)(i), you must
meet the reporting requirements in
paragraphs (c)(1) through (8) of this
section.
(1) Contact information. You must
provide contact information by April 4,
2007, and provide updates within 30
days if this information changes. The
contact information must be submitted
using EPA’s electronic data reporting
system, as specified in paragraph (b)(1)
of this section, and include the name,
affiliation, mailing address, phone
number, fax number, and e-mail address
for your PWS Technical Contact and
your PWS Official.
(2) Sampling location and inventory
information. You must provide your
sampling location and inventory
information by August 2, 2007 using
EPA’s electronic data reporting system.
You must submit the following
information for each sampling location,
or for each approved representative
sampling location (as specified in
paragraph (c)(3) of this section regarding
representative sampling locations): PWS
identification (PWSID) code; PWS
facility identification code; water source
type, sampling point identification
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code; and sampling point type code; ( as
defined in Table 1, paragraph (e) of this
section). If this information changes,
you must report updates to EPA’s
electronic data reporting system within
30 days of the change.
(3) Proposed ground water
representative sampling locations. Some
systems that use ground water as a
source and have multiple entry points to
the distribution system (EPTDSs) may
propose monitoring at representative
entry point(s), rather than monitor at
every EPTDS, as follows:
(i) Qualifications. Large PWSs that
have EPA- or State-approved alternate
EPTDS sampling locations from a
previous UCMR cycle, or as provided
for under §§ 141.23(a)(1), 141.24(f)(1), or
141.24(h)(1), may submit a copy of
documentation from their State or EPA
that approves their alternative sampling
plan for EPTDSs. PWSs that do not have
an approved alternative EPTDS
sampling plan may submit a proposal to
sample at representative EPTDS(s)
rather than at each individual EPTDS if:
They use ground water as a source; all
of their well sources have either the
same treatment or no treatment; and
they have multiple EPTDSs from the
same source, such as an aquifer. You
must submit a copy of the existing
alternate EPTDS sampling plan or your
representative well proposal, as
appropriate, by May 4, 2007, as
specified in paragraph (b)(1) of this
section.
(ii) Demonstration. If you are
submitting a proposal to sample at
representative EPTDS(s) rather than at
each individual EPTDS, you must
demonstrate that any EPTDS that you
select as representative of the ground
water you supply from multiple wells is
associated with a well that draws from
the same aquifer as the wells it will
represent. You must submit the
following information for each proposed
representative sampling location:
PWSID Code, PWS Facility
Identification Code, and Sampling Point
Identification Code (as defined in Table
1, paragraph (e) of this section). You
must also include documentation to
support your proposal that the specified
wells are representative of other wells.
This documentation can include
system-maintained well logs or
construction drawings indicating that
the representative well(s) is/are at a
representative depth, and details of well
casings and grouting; data
demonstrating relative homogeneity of
water quality constituents (e.g., pH,
dissolved oxygen, conductivity, iron,
manganese) in samples drawn from each
well; and data showing that your wells
are located in a limited geographic area
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(e.g., all wells within a 0.5 mile radius)
and/or, if available, the hydrogeologic
data indicating the time of travel
separating the representative well from
each of the individual wells it
represents (e.g., all wells within a fiveyear time of travel delineation). Your
proposal must be sent in writing to EPA,
as specified in paragraph (b)(1) of this
section. You must also provide a copy
of this information to the State, unless
otherwise directed by the State.
Information about the actual or potential
occurrence or non-occurrence of
contaminants in an individual well, or
a well’s vulnerability to contamination,
must not be used as a basis for selecting
a representative well.
(iii) Approval. EPA or the State (as
specified in the Partnership Agreement
reached between the State and EPA)
will review your proposal, coordinate
any necessary changes with you, and
approve the final list of EPTDSs where
you will be required to monitor. Your
plan will not be final until you receive
written approval from EPA or the State.
(4) Contacting EPA if your PWS has
not been notified of requirements. If you
believe you are subject to UCMR
requirements, as defined in
§ 141.40(a)(1) and (2)(i), and you have
not been notified by either EPA or your
State by June 4, 2007, you must send a
letter to EPA, as specified in paragraph
(b)(1) of this section. The letter must be
from your PWS Official and must
include an explanation as to why the
UCMR requirements are applicable to
your system along with the appropriate
contact information. A copy of the letter
must also be submitted to the State, as
directed by the State. EPA will make an
applicability determination based on
your letter, and in consultation with the
State when necessary, and will notify
you regarding your applicability status
and required sampling schedule.
However, if your PWS meets the
applicability criteria specified in
§ 141.40(a)(2)(i), you are subject to the
UCMR monitoring and reporting
requirements, regardless of whether you
have been notified by the State or EPA.
(5) Notifying EPA if your PWS cannot
sample according to schedule.
(i) General rescheduling notification
requirements. Large systems may
change their Assessment Monitoring
(List 1) or Screening Survey (List 2)
schedule up to August 2, 2007 using
EPA’s electronic data reporting system,
as specified in paragraph (b)(1) of this
section. After these dates have passed,
if your PWS cannot sample according to
your assigned sampling schedule (e.g.,
because of budget constraints, or if a
sampling location will be closed during
the scheduled month of monitoring),
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you must fax, mail, or e-mail a letter to
EPA, as specified in paragraph (b)(1) of
this section, prior to the scheduled
sampling date. You must include an
explanation of why the samples cannot
be taken according to the assigned
schedule and the alternative schedule
you are requesting. You are subject to
your assigned UCMR sampling schedule
or the schedule that you revised on or
before August 2, 2007, unless and until
you receive a letter from EPA specifying
a new schedule.
(ii) Exceptions to the rescheduling
notification requirements. For ground
water sampling, if the second round of
sampling will be completed five to
seven months after the first sampling
event, as specified in Table 2 of
§ 141.40(a)(4)(i)(B), no notification to
EPA is required. If any ground water
sampling location will be nonoperational for more than one month
before and one month after the month
in which the second sampling event is
scheduled (i.e., it is not possible for you
to sample within the five to seven
month window), you must notify EPA,
as specified in paragraph (b)(1) of this
section, explaining why the schedule
cannot be met. You must comply with
any modified schedule provided by
EPA.
(6) Reporting monitoring results. For
each sample, you must report the
information specified in Table 1 of
paragraph (e) of this section, using
EPA’s electronic data reporting system,
as follows. If you are conducting
Assessment Monitoring, you must
include data elements 1 through 5, and
7 through 15 in paragraph (e) of this
section; and if you are conducting
Screening Survey monitoring, you must
include elements 1 through 15. You also
must report any changes 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.
(i) Electronic reporting system. You
are responsible for ensuring that the
laboratory conducting the analysis of
your unregulated contaminant
monitoring samples (your laboratory)
posts the analytical results to EPA’s
electronic reporting system. You are
also responsible for reviewing,
approving, and submitting those results
to EPA.
(ii) Reporting schedule. You must
ensure that your laboratory posts the
data to EPA’s electronic data reporting
system within 120 days from the sample
collection date (sample collection must
occur as specified in § 141.40(a)(4)). You
have 60 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 take action on the data within 60
days of the laboratory’s posting to the
electronic reporting system, the data
will be considered approved by you,
and available for EPA and State review.
(7) Only one set of results accepted. If
you report more than one set of valid
results for the same sampling location
and the same sampling event (for
example, because you have had more
than one laboratory analyze replicate
samples collected under § 141.40(a)(5),
or because you have collected multiple
samples during a single monitoring
event at the same sampling location),
EPA will use the highest of the reported
values as the official result.
(8) No reporting of previously
collected data. You cannot report
previously collected data to meet the
testing and reporting requirements for
the contaminants listed in
§ 141.40(a)(3). All analyses must be
performed by laboratories approved by
EPA to perform UCMR analyses using
the analytical methods specified in
Table 1 of § 141.40(a)(3) and using
samples collected according to
§ 141.40(a)(4). Such requirements
preclude the possibility of
‘‘grandfathering’’ previously collected
data.
391
(d) Reporting by small systems. If you
serve a population of 10,000 or fewer
people, and you are notified that you
have been selected for UCMR
monitoring, your reporting requirements
will be specified within the materials
that EPA sends you, including a request
for contact information, and a request
for information associated with the
sampling kit.
(1) Contact information. EPA will
send you a notice requesting contact
information for key individuals at your
system, including name, affiliation,
mailing address, phone number, fax
number, and e-mail address. These
individuals include your PWS
Technical Contact and your PWS
Official. You are required to provide
this information within 90 days of
receiving the notice from EPA as
specified in paragraph (b)(1) of this
section. If this information changes, you
also must provide updates within 30
days of the change, as specified in
paragraph (b)(1) of this section.
(2) Reporting sampling information.
You must record 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, as follows: If you are
conducting Assessment Monitoring, you
must include elements 1 through 5, and
7; if you are conducting Screening
Survey, you must include elements 1
through 7. 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) Data elements. Table 1 defines the
data elements that must be provided
with UCMR sample results.
TABLE 1.—UNREGULATED CONTAMINANT MONITORING REPORTING REQUIREMENTS
Data element
Definition
1. Public Water System Identification (PWSID) Code .......
The code used to identify each PWS. The code begins with the standard 2-character
postal State abbreviation or Region code; the remaining 7 numbers are unique to
each PWS in the State. The same identification code must be used to represent the
PWS identification for all current and future UCMR monitoring.
An identification code established by the State or, at the State’s discretion, by the
PWS, following the format of a 5-digit number unique within each PWS for each applicable facility (i.e., for each source of water, treatment plant, distribution system, or
any other facility associated with water treatment or delivery). The same identification
code must be used to represent the facility for all current and future UCMR monitoring.
The type of source water that supplies a water system facility. Systems must report
one of the following codes for each sampling location:
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2. Public Water System Facility Identification Code ..........
3. Water Source Type ........................................................
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TABLE 1.—UNREGULATED CONTAMINANT MONITORING REPORTING REQUIREMENTS—Continued
Data element
Definition
4. Sampling Point Identification Code ................................
5. Sampling Point Type Code ............................................
6. Disinfectant Residual Type ............................................
7. Sample Collection Date .................................................
8. Sample Identification Code ............................................
9. Contaminant ...................................................................
10. Analytical Method Code ...............................................
11. Sample Analysis Type .................................................
12. Analytical Results—Sign ..............................................
13. Analytical Result—Value ..............................................
14. Laboratory Identification Code .....................................
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15. Sample Event Code .....................................................
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SW = surface water (to be reported for water facilities that are served all or in
part by a surface water source at any time during the twelve-month period).
GW = ground water (to be reported for water facilities that are served entirely by
a ground water source).
GU = ground water under the direct influence of surface water (to be reported
for water facilities that are served all or in part by ground water under the direct
influence of surface water at any time during the twelve-month sampling period),
and are not served at all by surface water during this period.
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.
A code that identifies the location of the sampling point as either:
EP = entry point to the distribution system.
MR = distribution system sample at maximum residence time.
The type of disinfectant in use at the time of UCMR sampling to maintain a residual
in the distribution system for each Screening Survey sampling point. To be reported
by systems required to conduct Screening Survey monitoring. Systems must report
using the following codes for each Screening Survey sampling location (i.e., EP,
MR):
CL = chlorine
CA = chloramine
OT = all other types of disinfectant (e.g., chlorine dioxide)
ND = no disinfectant used.
The date the sample is collected, reported as 4-digit year, 2-digit month, and 2-digit
day.
An alphanumeric value up to 30 characters assigned by the laboratory to uniquely
identify containers, or groups of containers, containing water samples collected at the
same sampling location for the same sampling date.
The unregulated contaminant for which the sample is being analyzed.
The identification code of the analytical method used.
The type of sample collected and/or prepared, as well as the fortification level. Permitted values include:
FS = field sample; sample collected and submitted for analysis under this rule.
LFSM = laboratory fortified sample matrix; a UCMR field sample with a known
amount of the contaminant of interest added.
LFSMD = laboratory fortified sample matrix duplicate; duplicate of the laboratory
fortified sample matrix.
CF = concentration fortified; reported with sample analysis types LFSM and
LFSMD, the concentration of a known contaminant added to a field sample.
A value indicating whether the sample analysis result was:
(<) ‘‘less than’’ means the contaminant was not detected, or was detected at a
level below the Minimum Reporting Level.
(=) ‘‘equal to’’ means the contaminant was detected at the level reported in ‘‘Analytical Result—Value.’’
The actual numeric value of the analytical results for: field samples; laboratory fortified matrix samples; laboratory fortified sample matrix duplicates; and concentration
fortified.
The code, assigned by EPA, used to identify each laboratory. The code begins with
the standard two-character State postal abbreviation; the remaining five numbers are
unique to each laboratory in the State.
A code assigned by the PWS for each sample event. This will associate samples
with the PWS monitoring plan to allow EPA to track compliance and completeness.
Systems must assign the following codes:
SE1 = represents samples collected to meet the UCMR monitoring requirement
for the first sampling period (all source types).
SE2 = represents samples collected to meet the UCMR monitoring requirement
for the second sampling period (all source types).
SE3 = represents samples collected to meet the UCMR monitoring requirement
for the third sampling period (surface water and ground water under the direct
influence of surface water (GWUDI) sources only).
SE4 = represents samples collected to meet the UCMR monitoring requirement
for the fourth sampling period (surface water and GWUDI sources only).
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Subpart E—[Amended]
4. Section 141.40 is revised to read as
follows:
I
§ 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
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.);
whether the system purchases all of its
water, as finished water, from another
system; and its population served as of
June 30, 2005.
(1) Applicability to transient noncommunity systems. If you own or
operate a transient non-community
water system, you do not have to
monitor that system for unregulated
contaminants.
(2) Applicability to community water
systems and non-transient noncommunity water systems.
(i) Large systems. If you own or
operate a wholesale or retail PWS (other
than a transient non-community system)
that serves more than 10,000 people,
and do not purchase your entire water
supply as finished water from another
PWS, 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).
(A) Assessment Monitoring. You must
monitor for the unregulated
contaminants on List 1 of Table 1,
UCMR Contaminant List, in paragraph
(a)(3) of this section. If you serve a
population of more than 10,000 people,
you are required to perform this
monitoring regardless of whether you
have been notified by the State or EPA.
(B) Screening Survey. You must
monitor for the unregulated
contaminants on List 2 (Screening
Survey) of Table 1, as specified in
paragraph (a)(3) of this section, if your
system serves 10,001 to 100,000 people
and you are notified by EPA or your
State that you are part of the State
Monitoring Plan for Screening Survey
testing. If your system serves more than
100,000 people, you are required to
conduct this Screening Survey testing
regardless of whether you have been
notified by the State or EPA.
(C) Pre-Screen Testing. You must
monitor for the unregulated
contaminants on List 3 of Table 1, in
paragraph (a)(3) of this section, if
notified by your State or EPA that you
are part of the Pre-Screen Testing.
(ii) Small systems. Small PWSs, as
defined in this paragraph, will not be
393
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 (other than
a transient system) that serves 10,000 or
fewer people and do not purchase your
entire water supply from another PWS,
you must monitor as follows:
(A) Assessment Monitoring. You must
monitor for the unregulated
contaminants on List 1 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 Assessment Monitoring.
(B) Screening Survey. You must
monitor for the unregulated
contaminants on List 2 of Table 1, in
paragraph (a)(3) of this section, if
notified by your State or EPA that you
are part of the State Monitoring Plan for
the Screening Survey.
(C) Pre-Screen Testing. You must
monitor 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.
(3) Analytes to be monitored. Lists 1,
2, and 3 of unregulated contaminants
are provided in the following table:
TABLE 1.—UCMR CONTAMINANT LIST
[List 1: Assessment Monitoring Chemical Contaminants]
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Dimethoate .............................................
Terbufos sulfone .....................................
2,2′,4,4′-tetrabromodiphenyl
ether
(BDE–47).
2,2′,4,4′,5-pentabromodiphenyl
ether
(BDE–99).
2,2′,4,4′,5,5′-hexabromobiphenyl (HBB)
2,2′,4,4′,5,5′-hexabromodiphenyl ether
(BDE–153).
2,2′,4,4′,6-pentabromodiphenyl
ether
(BDE–100).
1,3-dinitrobenzene ..................................
2,4,6-trinitrotoluene (TNT) ......................
Hexahydro-1,3,5-trinitro-1,3,5-triazine
(RDX).
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6—Period during which
monitoring to be completed
3—Analytical methods a
4—Minimum
reporting
level b
5—Sampling location c
60–51–5
56070–16–7
5436–43–1
EPA 527 d ...
EPA 527 d ...
EPA 527 d ...
0.7 µg/L ......
0.4 µg/L ......
0.3 µg/L ......
EPTDS ...............................
EPTDS ...............................
EPTDS ...............................
1/1/2008–12/31/2010
1/1/2008–12/31/2010
1/1/2008–12/31/2010
60348–60–9
EPA 527 d ...
0.9 µg/L ......
EPTDS ...............................
1/1/2008–12/31/2010
59080–40–9
68631–49–2
EPA 527 d ...
EPA 527 d ...
0.7 µg/L ......
0.8 µg/L ......
EPTDS ...............................
EPTDS ...............................
1/1/2008–12/31/2010
1/1/2008–12/31/2010
189084–64–8
EPA 527 d ...
0.5 µg/L ......
EPTDS ...............................
1/1/2008–12/31/2010
99–65–0
118–96–7
121–82–4
EPA 529 e ...
EPA 529 e ...
EPA 529 e ...
0.8 µg/L ......
0.8 µg/L ......
1 µg/L .........
EPTDS ...............................
EPTDS ...............................
EPTDS ...............................
1/1/2008–12/31/2010
1/1/2008–12/31/2010
1/1/2008–12/31/2010
2—CAS registry number
1—Contaminant
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TABLE 1.—UCMR CONTAMINANT LIST
[List 2: Screening Survey Chemical Contaminants
2—CAS registry number
1—Contaminant
3—Analytical methods a
4—Minimum
reporting
level b
5—Sampling location c
6—Period during which
monitoring to be completed
Acetanilide Pesticide Degradation Products
Acetochlor ESA ......................................
Acetochlor OA ........................................
Alachlor ESA ..........................................
Alachlor OA ............................................
Metolachlor ESA .....................................
Metolachlor OA .......................................
187022–11–3
184992–44–4
142363–53–9
171262–17–2
171118–09–5
152019–73–3
EPA
EPA
EPA
EPA
EPA
EPA
535 f
535 f
535 f
535 f
535 f
535 f
...
...
...
...
...
...
1
2
1
2
1
2
µg/L
µg/L
µg/L
µg/L
µg/L
µg/L
.........
.........
.........
.........
.........
.........
EPTDS
EPTDS
EPTDS
EPTDS
EPTDS
EPTDS
...............................
...............................
...............................
...............................
...............................
...............................
1/1/2008–12/31/2010
1/1/2008–12/31/2010
1/1/2008–12/31/2010
1/1/2008–12/31/2010
1/1/2008–12/31/2010
1/1/2008–12/31/2010
EPTDS ...............................
EPTDS ...............................
EPTDS ...............................
1/1/2008–12/31/2010
1/1/2008–12/31/2010
1/1/2008–12/31/2010
DSMRT and EPTDS .........
DSMRT and EPTDS .........
DSMRT and EPTDS .........
DSMRT and EPTDS .........
DSMRT and EPTDS .........
DSMRT and EPTDS .........
Reserved i ..........................
1/1/2008–12/31/2010
1/1/2008–12/31/2010
1/1/2008–12/31/2010
1/1/2008–12/31/2010
1/1/2008–12/31/2010
1/1/2008–12/31/2010
Reserved i
Acetanilide Pesticide Parent Compounds
Acetochlor ...............................................
Alachlor ...................................................
Metolachlor .............................................
34256–82–1
15972–60–8
51218–45–2
EPA 525.2 g
EPA 525.2 g
EPA 525.2 g
2 µg/L .........
2 µg/L .........
1 µg/L .........
Nitrosamines
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N-nitrosodiethylamine (NDEA) ...............
N-nitroso-dimethylamine (NDMA) ..........
N-nitroso-di-n-butylamine (NDBA) ..........
N-nitroso-di-n-propylamine (NDPA) .......
N-nitroso-methylethylamine (NMEA) ......
N-nitrosopyrrolidine (NPYR) ...................
Reserved i ...............................................
55–18–5
62–75–9
924–16–3
621–64–7
10595–95–6
930–55–2
Reserved i
EPA 521 h
EPA 521 h
EPA 521 h
EPA 521 h
EPA 521 h
EPA 521 h
Reserved i
...
...
...
...
...
...
...
0.005 µg/L ..
0.002 µg/L ..
0.004 µg/L ..
0.007 µg/L ..
0.003 µg/L ..
0.002 µg/L ..
Reserved i ...
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.
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.
5—Sampling Location: The locations within a PWS at which samples must be collected.
6—Period During Which Monitoring to Be Completed: The dates during which the sampling and testing are to occur for the indicated contaminant.
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—h was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Information 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
B102, 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/.
a The version of the EPA methods which you must follow for this Regulation are listed in d—h as follows.
b The Minimum Reporting Level (MRL) was established by EPA by adding the mean of the Lowest Concentration Minimum Reporting Levels
(LCMRL) determined according to the procedure detailed in ‘‘Statistical Protocol for the Determination of The Single-Laboratory Lowest Concentration Minimum Reporting Level (LCMRL) and Validation of the Minimum Reporting Level (MRL)’’ 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. Note that EPA Method 525.2 was developed prior to UCMR 2, hence the LCMRLs were not determined for analytes determined by
this method.
c Sampling must occur at entry points to the distribution system (EPTDSs) after treatment is applied that represent each non-emergency water
source in routine use over the 12-month period of monitoring. See 40 CFR 141.35(c)(3) for an explanation of the requirements related to use of
representative EPTDSs. Sampling for nitrosamines on List 2 must also occur at the disinfection byproduct distribution system maximum residence time (DSMRT) sampling locations as defined in 40 CFR 141.132(b)(1)(i) and at EPTDS sampling locations. If a treatment plant/water
source is not subject to the sampling required in 40 CFR 141.132(b)(1), then the samples for nitrosamines must be collected only at the EPTDS
location(s).
d EPA Method 527 ‘‘Determination of Selected Pesticides and Flame Retardants in Drinking Water by Solid Phase Extraction and Capillary
Column Gas Chromatography/Mass Spectrometry (GC/MS),’’ Revision 1.0, April 2005 is available at https://www.epa.gov/safewater/methods/
sourcalt.html.
e EPA Method 529 ‘‘Determination of Explosives and Related Compounds in Drinking Water by Solid Phase Extraction and Capillary Column
Gas Chromatography/Mass Spectrometry (GC/MS),’’ Revision 1.0, September 2002 is available at https://www.epa.gov/nerlcwww/ordmeth.htm.
f EPA Method 535 ‘‘ Measurement of Chloroacetanilide and Other Acetamide Herbicide Degradates in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS),’’ Version 1.1, April 2005 is available at https://www.epa.gov/nerlcwww/
ordmeth.htm.
g EPA Method 525.2 ‘‘Determination of Organic Compounds in Drinking Water by Liquid-Solid Extraction and Capillary Column Gas Chromatography/Mass Spectrometry,’’ Revision 2.0, 1995 is available at https://www.NEMI.gov.
h EPA Method 521 ‘‘Determination of Nitrosamines in Drinking Water by Solid Phase Extraction and Capillary Column Gas Chromatography
with Large Volume Injection and Chemical Ionization Tandem Mass Spectrometry (MS/MS),’’ Version 1.0, September 2004 is available at https://
www.epa.gov/nerlcwww/ordmeth.htm.
i To be determined at a later time.
(4) Sampling requirements.
(i) Large systems. If you serve more
than 10,000 people and meet the UCMR
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applicability criteria specified in
paragraph (a)(2)(i) of this section, you
must comply with the requirements
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specified in paragraphs (a)(4)(i)(A)
through (I) of this section. Your samples
must be collected according to the
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schedule that you are assigned by EPA
or your State, or the schedule that you
revised using EPA’s electronic data
reporting system on or before August 2,
2007. Your schedule must follow both
the timing and frequency of monitoring
specified in Tables 1 and 2 of this
section.
(A) Monitoring period. You must
collect the samples in one continuous
12-month period for List 1 Assessment
Monitoring, and, if applicable, for List 2
Screening Survey, or List 3 Pre-Screen
Testing, during the time frame indicated
in column 6 of Table 1, in paragraph
(a)(3) of this section. EPA or your State
will specify the month(s) and year(s) in
which your monitoring must occur. As
specified in § 141.35(c)(5), you must
contact EPA if you believe you cannot
conduct monitoring according to your
schedule.
(B) Frequency. You must collect the
samples within the time frame and
according to the frequency specified by
contaminant type and water source type
395
for each sampling location, as specified
in Table 2, in this paragraph, with the
following exception. For the second
round of ground water sampling, if a
sample location is non-operational 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 five to seven month
window specified the Table 2, in this
paragraph), you must notify EPA as
specified in § 141.35(c)(5).
TABLE 2.—MONITORING FREQUENCY BY CONTAMINANT AND WATER SOURCE TYPES
Water source type
Time frame
Frequency
Chemical ..............................................
mstockstill on PROD1PC61 with RULES2
Contaminant type
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 ......................
You must monitor twice
in a consecutive 12month period. Sample
events must occur 5–
7 months apart.
(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 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 Screening Survey
monitoring must also sample for
nitrosamines 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).
(D) Sampling instructions. For each
List 1 Assessment Monitoring
contaminant, and, if applicable, for each
List 2 Screening Survey, or List 3 PreScreen Testing contaminant, you must
follow the sampling procedure for the
method specified in column 3 of Table
1, in paragraph (a)(3) of this section. In
addition, you must not composite (that
is, combine, mix, or blend) the samples;
you must collect and preserve each
sample separately. Samples collected for
the analysis of Acetanilide ‘‘parent’’
pesticides and their degradation
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products (Methods 525.2 and 535) must
be collected at the same sampling point,
at the same time.
(E) Sample collection and shipping
time. If you must ship the samples for
analysis, you must collect the samples
early enough in the day to allow
adequate time to send the samples for
overnight delivery to the laboratory.
You should not collect samples on
Friday, Saturday, or Sunday because
sampling on these days may not allow
samples to be shipped and received at
the laboratory at the required
temperature, unless you have made
special arrangements with your
laboratory to receive the samples.
(F) Analytical methods. For each
contaminant, you must use the
respective analytical methods for List 1,
and, if applicable, for List 2, or List 3
that are specified in column 3 of Table
1, in paragraph (a)(3) of this section;
report values at or above the minimum
reporting levels for List 1, and, if
applicable, for List 2 Screening Survey,
or List 3 Pre-Screen Testing, that are
specified in column 4 of Table 1, in
paragraph (a)(3) of this section; and
conduct the quality control procedures
specified in paragraph (a)(5) of this
section.
(G) Laboratory errors or sampling
deviations. If the laboratory data do not
meet the required QC criteria, as
specified in paragraph (a)(5) of this
section, or you do not follow the
required sampling procedures, as
specified in paragraphs (a)(4) of this
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section, you must resample within 30
days of being informed or becoming
aware of these facts. This resampling is
not for the purpose of confirming
previous results, but to correct the
sampling or laboratory error. All
systems must report the results obtained
from the first sampling for each
sampling period, except for cases of
sampling or laboratory errors. For the
purposes of this rule, no samples are to
be recollected for the purposes of
confirming the results observed in a
previous sampling.
(H) Analysis. For the List 1
contaminants, and, if applicable, List 2
Screening Survey, or List 3 Pre-Screen
Testing contaminants, identified in
Table 1, paragraph (a)(3) of this section,
you must arrange for testing by a
laboratory that has been approved by
EPA according to requirements in
paragraph (a)(5)(ii) of this section.
(I) Review and reporting of results.
After you have received the laboratory
results, you must review, approve, and
submit the system information, and
sample collection data and test results.
You must report the results as provided
in § 141.35(c)(6).
(ii) Small systems. If you serve 10,000
or fewer people and are notified that
you are part of the State Monitoring
Plan for Assessment Monitoring,
Screening Survey or Pre-Screen
monitoring, you must comply with the
requirements specified in paragraphs
(a)(4)(i)(A) through (H) of this section. If
EPA or the State informs you that they
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Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
will be collecting your UCMR samples,
you must assist them in identifying the
appropriate sampling locations and in
collecting the samples.
(A) Monitoring period and frequency.
You must collect samples at the times
specified for you by the State or EPA.
Your schedule must follow both the
timing of monitoring specified in Table
1, List 1, and, if applicable, List 2, or
List 3, and the frequency of monitoring
in Table 2 of this section.
(B) Location. You must collect
samples at the locations specified for
you by the State or EPA.
(C) Sample kits. You must store and
maintain the sample collection kits sent
to you by the UCMR Sampling
Coordinator in accordance with the kit’s
instructions. The sample kit will
include all necessary containers,
packing materials and cold packs,
instructions for collecting the sample
and sample treatment (such as
dechlorination or preservation), report
forms for each sample, contact name
and telephone number for the
laboratory, and a prepaid return
shipping docket and return address
label. If any of the materials listed in the
kit’s instructions are not included in the
kit or arrive damaged, you must notify
the UCMR Sampling Coordinator who
sent you the sample collection kits.
(D) Sampling instructions. You must
comply with the instructions sent to you
by the State or EPA concerning the use
of containers, collection (how to fill the
sample bottle), dechlorination and/or
preservation, and sealing and
preparation of sample and shipping
containers for shipment. You must not
composite (that is, combine, mix, or
blend) the samples. You also must
collect, preserve, and test each sample
separately. You must also comply with
the instructions sent to you by the
UCMR Sampling Coordinator
concerning the handling of sample
containers for specific contaminants.
(E) Sampling deviations. If you do not
collect a sample according to the
instructions provided to you for a listed
contaminant, you must report the
deviation within 7 days of the
scheduled monitoring on the sample
reporting form, as specified in
§ 141.35(d)(2). You must resample
following instructions that you will be
sent from the UCMR Sampling
Coordinator or State. A copy of the form
must be sent to the laboratory with the
recollected samples, and to the UCMR
Sampling Coordinator.
(F) Duplicate samples. EPA will select
a subset of systems in the State
Monitoring Plan that must collect
duplicate samples for quality control. If
your system is selected, you will receive
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two sample kits for an individual
sampling location that you must use.
You must use the same sampling
protocols for both sets of samples,
following the instructions in the
duplicate sample kit.
(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. If you are conducting
Assessment Monitoring, you must
include elements 1 through 5, and 7;
and if you are conducting Screening
Survey, you must include elements 1
through 7. You must sign and date the
sampling forms.
(H) Sample collection and shipping.
You must collect the samples early
enough in the day to allow adequate
time to send the samples for overnight
delivery to the laboratory. You should
not collect samples on Friday, Saturday,
or Sunday because sampling on these
days may not allow samples to be
shipped and received at the laboratory
at the required temperature unless you
have made special arrangements with
EPA for the laboratory to receive the
samples. Once you have collected the
samples and completely filled in the
sampling forms, you must send the
samples and the sampling forms to the
laboratory designated on the air bill.
(5) Quality control requirements. If
your system serves more than 10,000
people, you must ensure that the quality
control requirements listed below are
met during your sampling procedures
and by the laboratory conducting your
analyses. You must also ensure that all
method quality control procedures and
all UCMR quality control procedures are
followed.
(i) Sample collection/preservation.
You must follow the sample collection
and preservation requirements for the
specified method for each of the
contaminants in Table 1, in paragraph
(a)(3) of this section. These
requirements specify sample containers,
collection, dechlorination, preservation,
storage, sample holding time, and
extract storage and/or holding time that
you must assure that the laboratory
follow.
(ii) Laboratory approval for Lists 1,
List 2 and List 3. To be approved to
conduct UCMR testing, the laboratory
must be certified under § 141.28 for one
or more compliance analyses;
demonstrate for each analytical method
it plans to use for UCMR testing that it
can meet the Initial Demonstration of
Capability (IDC) requirements detailed
in the analytical methods specified in
column 3 of Table 1, in paragraph (a)(3)
of this section; and successfully
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participate in the UCMR Proficiency
Testing (PT) Program administered by
EPA for each analytical method it plans
to use for UCMR testing. UCMR
laboratory approval decisions will be
granted on an individual method basis
for the methods listed in column 3 of
Table 1 in paragraph (a)(3) of this
section for List 1, List 2, and List 3
contaminants. Laboratory approval is
contingent upon the capability of the
laboratory to post monitoring data to the
EPA electronic data reporting system.
To participate in the UCMR Laboratory
Approval Program, the laboratory must
complete and submit the necessary
registration forms by April 4, 2007.
Correspondence must be addressed to:
UCMR 2 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 the lowest analyte concentration
for which future recovery is predicted to
fall, with high confidence (at least 99%),
between 50% and 150% recovery.
(A) Validation of laboratory
performance. Your laboratory must be
capable of quantifying each contaminant
listed in Table 1, at or below the MRL
specified in column 4 of Table 1, in
paragraph (a)(3) of this section. You
must ensure that the laboratory
completes and has on file and available
for your inspection, records of two
distinct procedures. First, your
laboratory must have conducted an IDC
involving replicate analyses at or below
the MRL as described in this paragraph.
Second, for each day that UCMR
analyses are conducted by your
laboratory, a validation of its ability to
quantify each contaminant, at or below
the MRL specified in column 4 of Table
1, in paragraph (a)(3) of this section,
following the procedure listed in
paragraph (a)(5)(iii)(B) of this section,
must be performed. The procedure for
initial validation of laboratory
performance at or below the MRL is as
follows:
(1) All laboratories using EPA
drinking water methods under UCMR
must demonstrate that they are capable
of meeting data quality objectives
(DQOs) at or below the MRL listed in
Table 1, column 4, in paragraph (a)(3) of
this section.
(2) The MRL, or any concentration
below the MRL, at which performance
is being evaluated, must be contained
within the range of calibration. The
calibration curve regression model and
the range of calibration levels that are
used in these performance validation
steps must be used in all routine sample
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analyses used to comply with this
regulation. Only straight line or
quadratic regression models are
allowed. The use of either weighted or
unweighted models is permitted. The
use of cubic regression models is not
permitted.
(3) Replicate analyses of at least seven
(7) fortified samples in reagent water
must be performed at or below the MRL
for each analyte, and must be processed
through the entire method procedure
(i.e., including extraction, where
applicable, and with all preservatives).
Equation 1
Where:
t is the Student’s t value with df degrees of
freedom and confidence level (1–a),
s is the sample standard deviation of n
replicate samples fortified at the MRL,
n is the number of replicates.
(5) The values needed to calculate the
PIR using Equation 1 are: Number of
replicates (n); Student’s t value with a
two-sided 99% confidence level for n
number of replicates; the average (mean)
of at least seven replicates; and the
sample standard deviation. Factor 1 is
referred to as the Half Range PIR
(HRPIR).
(4) A prediction interval of results
(PIR), which is based on the estimated
arithmetic mean of analytical results
and the estimated sample standard
deviation of measurement results, must
be determined by Equation 1:
PIR = Mean ± s × t ( df , 1− α / 2 ) × 1 +
HR PIR = s × t ( df , 1− α / 2 ) × 1 +
1
n
For a certain number of replicates and
for a certain confidence level in
Student’s t, this factor
1
n
constant factor (C) for replicate sample
numbers 7 through 10 with a confidence
level of 99% for Student’s t.
(6) The HRPIR is calculated by
Equation 2:
Equation 2
1
C = t ( df , 1− α / 2 ) × 1 +
n
is constant, and can be tabulated
according to replicate number and
confidence level for the Student’s t.
Table 3 in this paragraph lists the
397
HR PIR = s × C
(7) The PIR is calculated by Equation
3:
Equation 3
PIR = Mean ± HR PIR
TABLE 3.—THE CONSTANT FACTOR (C) TO BE MULTIPLIED BY THE STANDARD DEVIATION TO DETERMINE THE HALF
RANGE INTERVAL OF THE PIR (STUDENT’S t 99% CONFIDENCE LEVEL) a
Replicates
Degrees of freedom
Constant factor (C) to be multiplied by the
standard
deviation
7
6
3.963
8
7
3.711
9
8
3.536
10
9
3.409
a The
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ER04JA07.004
ER04JA07.003
for each analyte must be converted to a
percent recovery, and if the recovery is
within 50%–150% (inclusive), the daily
performance of the laboratory has been
validated. The results for any analyte for
which 50%–150% recovery cannot be
demonstrated during the daily check are
not valid. Laboratories may elect to rerun the daily performance check sample
if the performance for any analyte or
analytes cannot be validated. If
performance is validated for these
analytes, the laboratory performance is
considered validated. Alternatively, the
laboratory may re-calibrate and repeat
the performance validation process for
all analytes.
(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
ER04JA07.002
(1) You must ensure that the
calibration curve regression model and
that the range of calibration levels that
are used in these performance
validation steps are used in future
routine sample analysis. Only straight
line or quadratic regression models are
allowed. The use of either weighted or
unweighted models is permitted. The
use of cubic regression models is not
permitted.
(2) You must ensure, once your
laboratory has performed an IDC as
specified in each analytical method
(demonstrating that DQOs are met at or
below an MRL), that a daily
performance check is performed for
each analyte and method. A single
laboratory blank, fortified at or below
the MRL for each analyte, must be
processed through the entire method
procedure. The measured concentration
ER04JA07.001
(8) The lower and upper result limits
of the PIR must be converted to percent
recovery of the concentration being
tested. To pass criteria at a certain level,
the PIR lower recovery limits cannot be
lower than the lower recovery limits of
the QC interval (50%), and the PIR
upper recovery limits cannot be greater
than the upper recovery limits of the QC
interval (150%). When either of the PIR
recovery limits falls outside of either
bound of the QC interval of recovery
(higher than 150% or less than 50%),
laboratory performance is not validated
at the concentration evaluated. If the
PIR limits are contained within both
bounds of the QC interval, laboratory
performance is validated for that
analyte.
(B) Quality control requirements for
validation of laboratory performance at
or below the MRL.
ER04JA07.000
mstockstill on PROD1PC61 with RULES2
critical t-value for a two-sided 99% confidence interval is equivalent to the critical t-value for a one-sided 99.5% confidence interval, due
to the symmetry of the t-distribution. PIR = Prediction Interval of Results.
398
Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules and Regulations
mstockstill on PROD1PC61 with RULES2
(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 2
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 sets. The first set must be
fortified at either the low-level or midlevel, and the second set must be
fortified with the other standard, either
the low-level or mid-level, whichever
was not used for the initial LFSM/
LFSMD set.) The low-level 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 acceptance criteria specified for
LFSM/LFSMD analyses. All LFSM/
LFSMD data are to be reported.
(v) Method defined quality control.
You must ensure that your laboratory
performs Laboratory Fortified Blanks
and Laboratory Performance Checks, as
appropriate to the method’s
requirements, for those methods listed
in Table 1, column 3, in paragraph (a)(3)
of this section. Each method specifies
acceptance criteria for these QC checks.
(vi) Reporting. You must ensure that
your laboratory reports the analytical
results and other data, with the required
data listed in Table 1, in § 141.35(e).
You must require your laboratory to
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submit these data electronically to the
State and EPA using EPA’s electronic
data reporting system, accessible at
(https://www.epa.gov/safewater/ucmr/
ucmr2/reporting.html), within 120 days
from the sample collection date. You
then have 60 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 60 days
of the laboratory’s posting to EPA’s
electronic reporting system, the data
will be considered approved and final
for State and EPA review.
(6) Violation of this rule.
(i) Monitoring violations. Any failure
to monitor in accordance with
§ 141.40(a)(3)–(5) is a monitoring
violation.
(ii) Reporting violations. Any failure
to report in accordance with § 141.35 is
a reporting violation.
(b) Petitions and Waivers by States.
(1) Governors’ petition for additional
contaminants. The Safe Drinking Water
Act allows Governors of seven (7) or
more States to petition the EPA
Administrator to add one or more
contaminants to the UCMR Contaminant
List in paragraph (a)(3) of this section.
The petition must clearly identify the
reason(s) for adding the contaminant(s)
to the monitoring list, including the
potential risk to public health,
particularly any information that might
be available regarding disproportional
risks to the health and safety of
children, the expected occurrence
documented by any available data, any
analytical methods known or proposed
to be used to test for the contaminant(s),
and any other information that could
assist the Administrator in determining
which contaminants present the greatest
public health concern and should,
therefore, be included on the UCMR
Contaminant List in paragraph (a)(3) of
this section.
(2) State-wide waivers. A State can
waive monitoring requirements only
with EPA approval and under very
limited conditions. Conditions and
procedures for obtaining a waiver are as
follows:
(i) Application. A State may apply to
EPA for a State-wide waiver from the
PO 00000
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unregulated contaminant monitoring
requirements for PWSs serving more
than 10,000 people. To apply for such
a waiver, the State must submit an
application to EPA that includes the
following information: The list of
contaminants on the UCMR
Contaminant List for which a waiver is
requested, along with documentation for
each contaminant in the request
demonstrating that the contaminants or
their parent compounds do not occur
naturally in the State, and certifying that
during the past 15 years they have not
been used, applied, stored, disposed of,
released, or detected in the source
waters or distribution systems in the
State.
(ii) Approval. EPA will review State
applications and notify the State
whether it accepts or rejects the request.
The State must receive written approval
from EPA before issuing a State-wide
waiver.
PART 142—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
IMPLEMENTATION
6. The authority citation for part 142
continues to read as follows:
I
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 B—[Amended]
7. Section 142.16 is amended by
revising paragraph (e) introductory text
to read as follows:
I
§ 142.16
Special primacy requirements.
*
*
*
*
*
(e) An application for approval of a
State program revision which adopts the
requirements specified in §§ 141.11,
141.23, 141.24, 141.32, 141.61, and
141.62 for a newly regulated
contaminant must contain the following
(in addition to the general primacy
requirements enumerated elsewhere in
this part, including the requirement that
State regulations be at least as stringent
as the Federal requirements):
*
*
*
*
*
[FR Doc. E6–22123 Filed 1–3–07; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Rules and Regulations]
[Pages 368-398]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-22123]
[[Page 367]]
-----------------------------------------------------------------------
Part II
Environmental Protection Agency
-----------------------------------------------------------------------
40 CFR Parts 9, 141, and 142
Unregulated Contaminant Monitoring Regulation (UCMR) for Public Water
Systems Revisions; Final Rule
Federal Register / Vol. 72, No. 2 / Thursday, January 4, 2007 / Rules
and Regulations
[[Page 368]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9, 141 and 142
[Docket No. OW-2004-0001; FRL-8261-7]
RIN 2040-AD93
Unregulated Contaminant Monitoring Regulation (UCMR) for Public
Water Systems Revisions
AGENCY: Environmental Protection Agency.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Safe Drinking Water Act (SDWA), as amended in 1996,
requires the United States Environmental Protection Agency (EPA) to
establish criteria for a program to monitor unregulated contaminants
and to publish a list of contaminants to be monitored every five years.
EPA published the first set of contaminants in 1999. This final
regulation meets the SDWA requirement by publishing the next set of
unregulated contaminants to be monitored and the requirements for such
monitoring.
This final rule describes the design for the second Unregulated
Contaminant Monitoring Regulation (UCMR) cycle (i.e., UCMR 2) of 2007-
2011. EPA is requiring monitoring of 25 chemicals using 5 different
analytical methods. UCMR 2 monitoring will occur during 2008-2010.
Implementation of this final rule will benefit the environment by
providing EPA and other interested parties with scientifically valid
data on the occurrence of these contaminants in drinking water, thereby
permitting the assessment of the population potentially being exposed
and the levels of that exposure. These data are the primary source of
occurrence and exposure data for the Agency to determine whether to
regulate these contaminants.
DATES: This final rule is effective on February 5, 2007. For purposes
of judicial review, this rule is promulgated as of 1 p.m. eastern time
on January 4, 2007 as provided in 40 CFR 23.7. The incorporation by
reference of certain publications listed in this rule is approved by
the Director of the Federal Register as of February 5, 2007.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. OW-2004-0001. All documents in the docket are listed in the index
at www.regulations.gov. Although listed in the index, some information
is not publicly available, e.g., confidential business information or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
at https://www.regulations.gov or in hard copy at the Water Docket, EPA/
DC, EPA West, Room 3334, 1301 Constitution Ave., 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 this
Public Reading Room is (202) 566-1744, and the telephone number for 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; e-
mail address munch.dave@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.
SUPPLEMENTARY INFORMATION:
I. General Information
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 will be required to monitor. A
community water system means a PWS which serves at least 15 service
connections used by year-round residents or regularly serves at least
25 year-round residents. Non-transient non-community water system means
a PWS that is not a community water system and that regularly serves at
least 25 of the same people over 6 months per year. Only a nationally
representative sample of community and non-transient non-community
systems serving 10,000 or fewer people will be required to monitor.
Transient non-community systems (i.e., systems that do not regularly
serve at least 25 of the same people over 6 months per year) will not
be required to monitor. States, Territories, and Tribes that qualify
for treatment as a State for purposes of this program, may participate
in the implementation of the second cycle of the Unregulated
Contaminant Monitoring Regulation (i.e., UCMR 2) through a Partnership
Agreement. These agencies may choose to conduct analyses to measure for
contaminants in water samples collected for the UCMR 2, in which case
they will be regulated by this action.
Regulated categories and entities are identified in the following
table.
------------------------------------------------------------------------
Examples of potentially
Category regulated entities NAICS\a\
------------------------------------------------------------------------
State, local, & tribal States, local and tribal 924110
Governments. governments that
analyze water samples
on behalf of PWSs
required to conduct
such analysis; States,
local and tribal
governments that
directly operate
community and non-
transient non-community
water systems required
to monitor.
Industry......................... Private operators of 221310
community and non-
transient non-community
water systems required
to monitor.
Municipalities................... Municipal operators of 924110
community and non-
transient non-community
water systems required
to monitor.
------------------------------------------------------------------------
\a\ NAICS = North American Industry Classification System.
This table is not intended to be 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
could 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 this final action. If you have questions regarding the applicability
of this action to a particular entity, consult the person
[[Page 369]]
listed in the preceding FOR FURTHER INFORMATION CONTACT section.
Abbreviations and Acronyms
HBB 2,2',4,4',5,5'-hexabromobiphenyl
[mu]g/L Microgram per liter
ASDWA Association of State Drinking Water Administrators
BDE-47 2,2',4,4'-tetrabromodiphenyl ether
BDE-99 2,2',4,4',5-pentabromodiphenyl ether
BDE-100 2,2',4,4',6-pentabromodiphenyl ether
BDE-153 2,2',4,4',5,5'-hexabromodiphenyl ether
CCL Contaminant Candidate List
CFR Code of Federal Regulations
DBP Disinfection Byproduct
DBPR Stage 1 or Stage 2 Disinfectants and Disinfection Byproducts Rule
DSMRT Distribution system maximum residence time
DQO Data quality objective
DWSRF Drinking Water State Revolving Fund
EPA United States Environmental Protection Agency
EPTDS Entry point to the distribution system
ESA Ethane sulfonic acid
FR Federal Register
GC Gas chromatography
GWUDI Ground water under the direct influence of surface water
HAA5 Haloacetic acid 5 (5 HAAs currently regulated)
HPLC High performance liquid chromatography
HRPIR Half range prediction interval of results
ICR Information collection request
IDC Initial demonstration of capability
IDSE Initial distribution system evaluation
IHS Indian Health Service
LC Liquid chromatography
LCMRL Lowest concentration minimum reporting level
LFSM Laboratory fortified sample matrix
LFSMD Laboratory fortified sample matrix duplicate
MCL Maximum contaminant level
MRL Minimum reporting level
MS Mass spectrometry
NAICS National American Industry Classification System
NCOD National Drinking Water Contaminant Occurrence Database
NDBA N-nitroso-di-n-butylamine
NDEA N-nitrosodiethylamine
NDMA N-nitrosodimethylamine
NDPA N-nitroso-di-n-propylamine
NMEA N-nitrosomethylethylamine
NPDWR National Primary Drinking Water Regulation
NPYR N-nitrosopyrrolidine
NTTAA National Technology Transfer and Advancement Act
OA Oxanilic acid
OMB Office of Management and Budget
PA Partnership agreement
PIR Prediction interval of results
PT Proficiency testing
PWS Public water system
PWSID Public water system identification
QA Quality assurance
QC Quality control
RDX Hexahydro-1,3,5-trinitro-1,3,5-triazine
RFA Regulatory Flexibility Act
RSD Relative standard deviation
SBA Small Business Administration
SDWA Safe Drinking Water Act
SDWARS Safe Drinking Water Accession and Review System
SDWIS Safe Drinking Water Information System
SPE Solid phase extraction
TNT 2,4,6-trinitrotoluene
TTHM Total trihalomethanes
UCMR Unregulated Contaminant Monitoring Regulation
UMRA Unfunded Mandates Reform Act of 1995
USEPA United States Environmental Protection Agency
Table of Contents
I. General Information
Does This Action Apply to Me?
II. Statutory Authority and Background
A. What Is the Statutory Authority for UCMR?
B. How Does EPA Meet These Statutory Requirements?
III. Summary of This Rule
A. What Are the Major Changes between the Proposed and Final
Rule?
Exhibit 1: Changes to UCMR 2 between Proposed and Final Rule
B. Which Water Systems Must Monitor?
1. This Rule
2. Summary of Major Comments
C. What Are the UCMR 2 Priority Contaminants and Associated
Methods?
1. List Compilation
Exhibit 2: Analytical Methods Approved for UCMR 2 Monitoring
2. Acetanilide Pesticides, Degradation Products, and Related
Methods
3. Explosives and Related Methods
4. Perchlorate and Related Methods
5. Nitrosamines/NDMA and Related Methods
6. Flame Retardants, Other Priority Contaminants, and Related
Methods
7. Triazines Chlorodegradates and Parent Compounds
8. Other Compounds That Were Considered
D. How Are Laboratories Approved for UCMR 2 Monitoring?
1. This Rule
2. Summary of Major Comments
E. What Is A System's Responsibility Regarding the Use of
Laboratories?
1. This Rule
2. Summary of Major Comments
F. What Specific Quality Control Requirements Must Be Followed?
1. Method Development Approach and Method Defined Quality
Control
2. Minimum Reporting Level
3. Lowest Concentration Minimum Reporting Level
4. Laboratory Fortified Sample Matrix and Laboratory Fortified
Sample Matrix Duplicate
G. When Are Samples Collected?
1. This Rule
2. Summary of Major Comments
H. Where Are Samples Collected?
1. Entry Points to the Distribution System
2. Distribution System Maximum Residence Time
I. How Should Samples Be Collected?
1. This Rule
2. Summary of Major Comments
J. What Are the UCMR 2 Reporting Requirements?
1. Information Required Prior to Monitoring
2. Reporting of Required Data Elements
3. Reporting Process
4. Cross-Media Reporting and Data Availability
K. What Constitutes a Violation Under UCMR 2?
L. Technical Correction Rule Changes in This Rule
1. Changes Pertaining to Aldicarb Monitoring
2. Changes Pertaining to State Primacy
IV. State and Tribal Participation
A. Partnership Agreements
1. This Rule
2. Summary of Major Comments
B. Governors' Petition and State-Wide Waivers
V. Cost and Benefits of This Rule
VI. 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
K. Congressional Review Act
VII. Public Involvement in Regulation Development
VIII. References
List of Exhibits
Exhibit 1: Changes to UCMR 2 between Proposed and Final Rule
Exhibit 2: Analytical Methods Approved for UCMR 2 Monitoring
[[Page 370]]
II. Statutory Authority and Background
A. What Is the Statutory Authority for UCMR?
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)
shall issue a list of no more than 30 unregulated contaminants to be
monitored by public water systems (PWSs), and that EPA enter the
monitoring data into the National Drinking Water Contaminant Occurrence
Database (NCOD). EPA's UCMR program must ensure that only a nationally
representative sample of PWSs serving 10,000 or fewer people will be
required to monitor; however, there are no such restrictions on the
number of systems serving more than 10,000 people. EPA must vary the
frequency and schedule for monitoring based on the number of people a
system serves, the source of supply, and the contaminants likely to be
found.
B. How Does EPA Meet These Statutory Requirements?
To fulfill the initial SDWA requirements, EPA published ``Revisions
to the Unregulated Contaminant Monitoring Regulation for Public Water
Systems; Final Rule,'' on September 17, 1999 (64 FR 50556, (USEPA,
1999)). Several supplemental rules were published to establish
analytical methods and to provide clarifications and refinements to the
initial rule: 65 FR 11372, March 2, 2000 (USEPA, 2000); 66 FR 2273,
January 11, 2001 (USEPA, 2001a); and 67 FR 65888, October 29, 2002
(USEPA, 2002b). SDWA, as amended in 1996, requires that at least once
every five years EPA identify a list of no more than 30 unregulated
contaminants to be monitored. This final action fulfills this statutory
obligation, identifying 25 priority contaminants for monitoring using
five analytical methods. EPA has developed a contaminant list (Exhibit
2, in Section III.C.1) and sampling design for UCMR 2 (2007-2011) with
input from both stakeholders and an EPA working group. This list is the
same as was presented in the proposed rule, with one exception:
perchlorate has been removed from the UCMR 2 monitoring requirements
(see Section III.C. 4 for further discussion).
III. Summary of This Rule
A. What Are the Major Changes Between the Proposed and Final Rule?
EPA published ``Revisions to the Unregulated Contaminant Monitoring
Regulation for Public Water Systems; Proposed Rule,'' on August 22,
2005 (70 FR 49094, (USEPA, 2005a)). EPA received comments from 36
public commenters.
In response to comments received and further consideration, EPA
removed perchlorate from the list of contaminants to be monitored for
under UCMR 2, and revised or clarified requirements pertaining to
system applicability criteria, reporting, monitoring, and quality
control. In addition, to accommodate PWS preparation for rule
implementation and to provide additional assurance of sufficient
laboratory capacity, this rule contains revised language that changes
the start of monitoring from July 2007 to January 2008, such that the
effective monitoring period is now January 2008 through December 2010.
Exhibit 1 provides a summary of these changes, and a listing of the
corresponding preamble section, which provides a more detailed
discussion of the revisions and related public comments. Sections
III.B-K summarize the different aspects of this rule and the associated
major comments received in response to the August 2005 proposed rule
and their impact, if any, on this rule.
This summary focuses on the changes between the proposed and final
rule, and requirements with deadlines that are triggered by the
publication date of this final rule. EPA has compiled a document
containing all public comments and EPA's responses entitled ``UCMR 2
Categorized Public Comments,'' which can be obtained by going to http:/
/www.regulations.gov, and searching for Docket ID No. OW-2004-0001
under the advanced search tab.
Exhibit 1.--Changes to UCMR 2 between Proposed and Final Rule
----------------------------------------------------------------------------------------------------------------
Rule section
--------------------------------------------------------------- Description of change Corresponding preamble
Number Title/description section
----------------------------------------------------------------------------------------------------------------
141.35(a)............................ General applicability.. Defines ``finished III.B.
water'' to clarify the
definition of
``population served''.
141.35(c)(3)(i)...................... Documenting ground Clarifies that approved III.J.1.c.
water representative representative well
sampling locations. plans from previous
UCMR cycles can be
submitted to identify
representative entry
point(s).
141.35(c)(5)......................... PWS notification of EPA Provides exception to III.J.1.d.
if sampling schedule notification
cannot be met. requirement for PWS
with ground water
sampling location that
can collect second
sample sets within 5-7
months of the first
sample set.
141.35(e)............................ Data Elements.......... Revises Table 1 of Sec. III.J.2.
141.35 to:
1. Clarify the
definition of ``Water
Source Type'' for a
sampling point..
2. Change the name of
``Sampling Point Type
Identification Code''
to ``Sampling Point
Type Code'' and
distinguish this data
element from
``Sampling Point
Identification Code''..
3. Clarify the
definition for
``Disinfectant
Residual Type''..
141.40(a)(3)......................... Analytes to be Revises Table 1 of III.G.
monitored and 141.40 to: III.C.4.
monitoring period. 1. Change monitoring III.F.2.
begin date to January
2008, and Screening
Survey monitoring
period to coincide
with Assessment
Monitoring..
2. Delete perchlorate
from table and
associated footnotes..
3. Revise minimum
reporting levels to
one significant
figure..
[[Page 371]]
141.40(a)(4)(i)(A)................... Monitoring schedules... Clarifies that EPA or III.G. and III.J.1.d.
the State will
determine PWS
monitoring schedules.
141.40(a)(4)(i)(B)................... Frequency.............. 1. Requires PWSs with III.G.
ground water sampling
locations that cannot
collect their second
samples within 5-7
months of the first
samples to contact EPA.
2. Changes Table 2 to
indicate that ground
water sample events
must occur 5-7 months
apart..
141.40(a)(4)(i)(D)................... Sampling Instructions.. 1. Clarifies that III.C.2; III.F.1; and
acetanilide parent and III.C.4.
degradates must be
sampled at the same
time and location.
2. Deletes reference to
collection methods for
perchlorate samples.
141.40(a)(4)(i)(G)................... Laboratory errors or Changes resampling III. I.
sampling deviations. deadline from within
14 days to within 30
days.
141.40(a)(5)(i)...................... Sample collection Deletes reference to III.C.4.
preservation. preservation methods
for perchlorate
samples.
141.40(a)(5)(iii)(B)(2).............. Quality control Deletes additional III.C.4.
requirements. quality control
requirements for
perchlorate methods.
141.40(a)(5)(iv)..................... Laboratory accuracy and Changes method III.F.4.
precision. requirement to fortify
the matrix at the
minimum reporting
level (MRL)
concentration to
within ;+/-50% vs. +/-
20%.
141.40(a)(5)(v)...................... Detection confirmation Deletes requirements in III.C.4 and III.F.1.
for perchlorate. this section; and
renumbers subsequent
paragraphs accordingly.
----------------------------------------------------------------------------------------------------------------
B. Which Water Systems Must Monitor?
1. This Rule
This rule requires that Assessment Monitoring be conducted by all
large community and non-transient, non-community water systems serving
more than 10,000 people, and a nationally representative sample of 800
small water systems serving 10,000 or fewer people. Transient non-
community water systems and those systems that purchase all of their
finished water from another system are excluded from the requirements
of UCMR 2. Assessment Monitoring is the largest in scope of the three
UCMR 2 monitoring components (or tiers). Under Assessment Monitoring,
``List 1'' contaminants, for which standard analytical methods are
available, are monitored to assess national occurrence in drinking
water. These are the priority contaminants for which analytical method
technologies are well established.
The second tier of UCMR 2 is referred to as ``List 2'' or Screening
Survey monitoring. List 2 contaminants are those for which analytical
methods have been recently developed, and for which the technologies
are not widely used; laboratory capacity, therefore, may be
insufficient to conduct the larger scale Assessment Monitoring. The
Screening Survey will be conducted by approximately 400 PWSs serving
more than 100,000 people (all systems in this largest size category),
by a randomly selected sample of 320 PWSs serving between 10,001 and
100,000 people, and by 480 small PWSs.
Pre-Screen Testing, the third tier of UCMR monitoring that is
designed for priority ``List 3'' contaminants, whose methods are very
new or specialized, is not required in this action, although EPA is
retaining the regulatory language that supports Pre-Screen Testing
authority as part of the three-tiered UCMR framework. If EPA ultimately
decides to include Pre-Screen Testing as part of this or a future UCMR,
EPA will initiate a rulemaking action to propose List 3 contaminants
(and their associated analytical methods) and to solicit public
comments.
This rule also defines ``population served'' as ``the number of
people served directly by the PWS'' plus those served ``by any
consecutive system receiving all or part of its finished water from
that PWS.'' To help clarify the definition of population served, the
final regulation will also include the definition of ``finished water''
that was recently finalized as part of the ``Stage 2 Disinfectants and
Disinfection Byproducts Rule'' (71 FR 388, January 4, 2006 (USEPA,
2006a)) as follows: ``Finished water is water that is introduced into
the distribution system of a public water system and is intended for
distribution and consumption without further treatment, except the
treatment necessary to maintain water quality in the distribution
system (e.g., booster disinfection, addition of corrosion control
chemicals).'' This final regulation also specifies the PWS system's
water source and population served, as of June 30, 2005, as the basis
for establishing a defined list of PWSs that are subject to the rule
requirements.
2. Summary of Major Comments
Comments included a recommendation for EPA to define the term
``finished water'' in EPA's definition of ``population served,'' and
support for the designation of the June 30, 2005, applicability date
because it would eliminate some of the confusion that occurred under
UCMR 1 and avoid extra effort to keep monitoring plans accurate and
current. In response to these comments, this final regulation contains
the definition of ``finished water'' that was recently finalized as
part of the Stage 2 Disinfection Byproducts Rule and retains the
proposed applicability date. EPA agrees that the specific applicability
date of June 30, 2005, will help to streamline the implementation
process.
Other comments included recommendations to publish the list of
systems that are subject to UCMR 2. Such a list, including preliminary
schedules, is posted on the UCMR Web page: https://www.epa.gov/
safewater/ucmr/ucmr2.
C. What Are the UCMR 2 Priority Contaminants and Associated Methods?
1. List Compilation
a. This Rule
This rule specifies 25 contaminants for monitoring, along with five
EPA
[[Page 372]]
Methods for analysis as listed in Exhibit 2. EPA began with a list of
over 200 contaminants, compiled from a variety of different sources,
including: UCMR 1 reserved contaminants; Candidate Contaminant List 1
(CCL 1) ``deferred pesticides''; CCL 1 suspected endocrine disruptors;
and other emerging contaminants. The CCL is a list of contaminants that
are not subject to any proposed or promulgated National Primary
Drinking Water Regulation (NPDWR), are known or anticipated to occur at
PWSs, and may require regulation under SDWA. The first CCL, published
in March 1998 (referred to as ``CCL 1''), identified 60 contaminants or
contaminant groups (63 FR 10274, March 2, 1998 (USEPA, 1998b)) that
were divided into categories to represent research and data needs for
each of the following: (1) Regulatory determination priorities; (2)
health effects research priorities; (3) treatment research priorities;
(4) analytical methods research priorities; and (5) occurrence
priorities. Through a multi-stepped review and prioritization process
(with relative health effects the top priority), the UCMR analyte list
was narrowed and prioritized, as described in the August 2005 proposed
rule, and 26 contaminants were identified. However, based on public
comment and further consideration, EPA has removed the requirement for
monitoring perchlorate under the UCMR 2 program (see Section III.C.4).
Exhibit 2.--Analytical Methods Approved for UCMR 2 Monitoring
------------------------------------------------------------------------
Analytical method \1\ Contaminant UCMR 2 ``List''
------------------------------------------------------------------------
EPA Method 527 (SPE/GC/MS).... 2,2',4,4'- List 1,
tetrabromodiphenyl Assessment
ether (BDE-47). Monitoring: 7
contaminants.
2,2',4,4',5-
pentabromodiphenyl
ether (BDE-99).
2,2',4,4',5,5'-
hexabromobiphenyl
(HBB).
2,2',4,4',5,5'-
hexabromodiphenyl
ether (BDE-153).
2,2',4,4',6-
pentabromodiphenyl
ether (BDE-100).
Dimethoate............
Terbufos sulfone......
EPA Method 529 (SPE/GC/MS).... 1,3-dinitrobenzene.... List 1,
Assessment
Monitoring: 3
contaminants.
2,4,6-trinitrotoluene
(TNT).
Hexahydro-1,3,5-
trinitro-1,3,5-
triazine (RDX).
EPA Method 521 (SPE/GC/CI/MS/ N-nitrosodiethylamine List 2,
MS). (NDEA). Screening
Survey: 6
contaminants.
N-nitrosodimethylamine
(NDMA).
N-nitroso-di-n-
butylamine (NDBA).
N-nitroso-di-n-
propylamine (NDPA).
N-
nitrosomethylethylami
ne (NMEA).
N-nitrosopyrrolidine
(NPYR).
EPA Method 535 (SPE/LC/MS/MS). Acetochlor ethane List 2,
sulfonic acid (ESA). Screening
Survey: 6
contaminants.
Acetochlor oxanilic
acid (OA).
Alachlor ESA..........
Alachlor OA...........
Metolachlor ESA.......
Metolachlor OA........
EPA Method 525.2 (SPE/GC/MS).. Acetochlor............ List 2,
Screening
Survey: 3
contaminants.
Alachlor..............
Metolachlor...........
Total of 25 UCMR 2
contaminants .
------------------------------------------------------------------------
\1\ EPA Method 521: Determination of Nitrosamines in Drinking Water by
Solid Phase Extraction and Capillary Column Gas Chromatography with
Large Volume Injection and Chemical Ionization Tandem Mass
Spectrometry (MS/MS) (USEPA, 2004a).
EPA Method 525.2: Determination of Organic Compounds in Drinking Water
by Liquid-Solid Extraction and Capillary Column Gas Chromatography/
Mass Spectrometry (USEPA, 1995).
EPA Method 527: Determination of Selected Pesticides and Flame
Retardants in Drinking Water by Solid Phase Extraction and Capillary
Column Gas Chromatography/Mass Spectrometry (GC/MS) (USEPA, 2004b).
EPA Method 529: Determination of Explosives and Related Compounds in
Drinking Water by Solid Phase Extraction and Capillary Column Gas
Chromatography/Mass Spectrometry (GC/MS) (USEPA, 2002a).
EPA Method 535, Revision 1.1: Measurement of Chloroacetanilide and Other
Acetamide Herbicide Degradates in Drinking Water by Solid Phase
Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/
MS) (USEPA, 2004c).
b. Summary of Major Comments
Some commenters supported the contaminant selection process in
general, but disagreed with EPA's criterion that pesticides must be
currently registered to be considered for UCMR 2 because pesticides can
persist even after they are no longer in use. EPA agrees that the issue
of pesticides and their degradates is an important one and will
consider, in future contaminant selection processes, the commenters'
concern about the requirement that pesticides be registered. EPA did
not receive comments on its health effects prioritization process.
Comments were received recommending that EPA substantially increase
the number of UCMR 2 contaminants because of the large number of
contaminants that are manufactured and sold in the United States.
Section 1445(a)(2)(B)(i) of SDWA specifically limits the number of
unregulated contaminants to 30 in each UCMR five-year cycle. The UCMR 2
list represents what EPA believes to be the highest priority drinking
water contaminants for which monitoring information is needed and
obtainable.
Further comments indicated that EPA needs to clarify the process
for prioritization of both UCMR and CCL contaminants. In general,
concern was expressed that EPA did not sufficiently explain the status
of CCL research
[[Page 373]]
priorities, especially with respect to the UCMR contaminant selection
process.
In the August 2005 preamble to the proposed rule, as well as in
other past Federal Register notifications, EPA has explained in detail
the connections between the CCL and the UCMR programs (https://
www.epa.gov/safewater/ucmr). The preamble to the proposed UCMR 2
regulation presented the logic behind the consideration of potential
analytes for the UCMR. Section III ``Requirements of the Unregulated
Contaminant Monitoring Program'' detailed all aspects of how EPA
selected the contaminants proposed in this regulation with subsections
describing what priority contaminants were selected for UCMR 2; a
compilation of the initial list of potential UCMR 2 candidates; how EPA
established priorities for UCMR 2; EPA's health effects prioritization
approach; and the specific information and considerations that went
into EPA's decisions on each analyte selected.
EPA has also been engaged in a multi-year process designed to
create an improved CCL process. This process began after the first CCL
was published in 1998 and EPA expects the next CCL (CCL 3) to reflect
substantial progress in implementing this new process. Because the new
CCL process was underway but not yet completed in 2005, CCL 2 carried
over the previous list and did not reflect the changes EPA is expecting
to make in identifying contaminants for possible regulation. EPA
expects that CCL 3 will reflect a more robust, transparent, and
systematic process to identify priority contaminants in drinking water
that will form the primary basis for future UCMR lists.
Before EPA can list a chemical compound or microbiological
parameter on UCMR, adequate analytical methods must be available. For
some of the chemicals (i.e., organotins, triazines and algal toxins)
and for all the microbiological parameters listed on the CCL, adequate
analytical methods have not yet been developed. EPA is actively engaged
in analytical method development research for these parameters both in-
house and through its various contracts and grant mechanisms. EPA
regularly publishes journal articles and other reports on the progress
of all of these research activities that are available for the public
to review.
2. Acetanilide Pesticides, Degradation Products, and Related Methods
a. This Rule
Under this rule, the three highest-use parent acetanilide
compounds, acetochlor, alachlor, and metolachlor, and their ESA and OA
degradation products are specified as List 2, Screening Survey
contaminants. The final rule also specifies EPA Method 525.2 for
analysis of the parent compounds and EPA Method 535 for analysis of the
acetanilide degradates. There were no changes between the proposed and
final rule language regarding these priority contaminants and their
associated methods. However, this rule contains revised language to
clarify that acetanilide parent and degradation product sampling must
be conducted at the same time and same location.
b. Summary of Major Comments
Some commenters did not agree with EPA's proposal to monitor the
three parent acetanilide compounds because some water systems include
these as part of their regulated volatile organic compound analyses
using EPA Method 525.2. Another recommendation was that no special
certification for Method 525.2 be required, since many laboratories are
already approved to conduct this analysis for regulated contaminants.
EPA is requiring monitoring of these three parent pesticides because it
is essential that the acetanilide parent and the degradation products
analysis be conducted using samples collected in the same location and
at the same time to provide data on their relative concentrations
(i.e., to establish relationships, if any, between the two). In
addition, because UCMR requires only a sample of PWSs to conduct
monitoring, and the resulting occurrence data is used to support EPA
decisions about whether to regulate a contaminant to protect public
health, the quality of data collected, at minimum reporting levels that
are considerably lower than those used for compliance monitoring, is
very important. Therefore, the analyses must meet even more stringent
quality control procedures than those used for other national drinking
water analyses, and special approval of laboratories is warranted for
both EPA Method 535 and 525.2. These analyses are required as part of
the Screening Survey, and therefore analytical costs to PWSs are
limited to approximately 720 large systems (EPA is paying for the
analytical costs of small system monitoring).
EPA agreed with recommendations in public comment to require
monitoring for acetanilide parents and their degradation products at
the same location and time to provide data on their relative
concentrations. The final regulation contains revised language to
include this requirement.
Finally, concern was expressed in public comments that EPA may
develop a single maximum contaminant level (MCL) for the parents plus
their degradates; commenters specifically pointed out that different
toxicity endpoints may exist for parents and degradates, and that a
single MCL could conflict with some state standards. EPA has made no
decision regarding whether or how to regulate these compounds. Such
decisions are beyond the scope of this rule.
3. Explosives and Related Methods
a. This Rule
Under this rule, EPA is requiring that three explosives: Hexahydro-
1,3,5-trinitro-1,3,5-triazine (RDX), 1,3-dinitrobenzene, and, 2,4,6-
trinitrotoluene (TNT) be monitored as part of List 1, Assessment
Monitoring. The final rule also specifies EPA Method 529 for analysis
of these compounds. There were no changes between the proposed and
final rule language regarding these priority contaminants and their
associated method.
b. Summary of Major Comments
Some commenters thought that other contaminants may be more
widespread and should take priority over explosives for testing.
However, if monitoring for explosives was required, the commenters
recommended that it be limited to areas near munitions facilities. The
explosives have not yet undergone a sufficiently widespread occurrence
study for EPA to be confident that these contaminants are only a
concern near munitions facilities. The decision to monitor for these
contaminants, versus others considered, was driven by their potential
health effects through the process described previously.
4. Perchlorate and Related Methods
a. This Rule
Under this rule, EPA has removed the requirement for monitoring
perchlorate under the UCMR 2 program. All references to perchlorate,
its associated methods, and specific quality control requirements have
been removed from the final rule. As a result, the requirements of
Sec. 141.40(a)(5)(v), Detection Confirmation, were deleted, and all
subsequent sections have been renumbered accordingly. The other rule
sections that were impacted by this decision (with reference to
perchlorate or relevant analytical methods being removed) are: Sec.
141.40(a)(3)--Analytes
[[Page 374]]
to be monitored; Sec. 141.40(a)(4)(i)(D)--Sampling Instructions; Sec.
141.40(a)(5)(i)--Sample collection/preservation; and Sec.
141.40(a)(5)(iii)(B)(2)--Quality control requirements for validation of
laboratory performance at or below the MRL.
b. Summary of Major Comments
Approximately 75 percent of commenters submitted comments on the
topic of perchlorate. The majority of the commenters did not support an
additional round of perchlorate monitoring, the most common reason
being the added cost of monitoring, without the perceived potential for
gaining sufficient, new information.
Monitoring for perchlorate was conducted during UCMR 1 in over
3,800 PWSs, with a minimum reporting level of 4.0 micrograms per liter
([mu]g/L). The data collected during this survey represents a
statistically valid set of high quality data that will inform EPA on
the occurrence and potential exposure to perchlorate from public
drinking water supplies. EPA will continue to evaluate these exposure
data along with other available information (e.g., health effects) as
the Agency makes its regulatory determination. Until that evaluation is
complete, EPA agrees with the commenters that it is not clear that the
Agency needs additional information on the occurrence of perchlorate in
drinking water. As a result, imposing additional perchlorate monitoring
costs on water systems is not warranted at this time. Therefore, EPA
has removed the requirement for monitoring perchlorate under the UCMR 2
program. If EPA later decides that additional perchlorate monitoring is
warranted, the Agency will undertake an appropriate rulemaking action.
5. Nitrosamines/NDMA and Related Methods
a. This Rule
This rule requires systems to monitor for six nitrosamines as part
of the List 2, Screening Survey. The final rule also specifies EPA
Method 521 for analysis of these compounds. There were no changes
between the proposed and final rule language regarding these priority
contaminants and their associated method.
b. Summary of Major Comments
Some commenters thought that nitrosamine sampling would be more
appropriately conducted as part of the Stage 1 and Stage 2 DBPRs. EPA
disagrees with these comments for several reasons. While in fact, to
date, the scientific literature identifies only N-nitroso-dimethylamine
(NDMA) and N-nitrosodiethylamine (NDEA) as disinfection byproducts, the
Screening Survey for nitrosamines is designed to aid in understanding
the proportion of nitrosamines, particularly NDMA, that results from
source water contamination versus that which results from disinfection.
Also, the nitrosamines in this regulation are all compounds projected
to have significant adverse health effects. All of these compounds are
probable human carcinogens with 10-\6\ cancer risk levels
that are in the low nanogram per liter range. These compounds would be
high priorities for monitoring whether their occurrence is the result
of source water contamination or disinfection.
Several commenters disagreed with the use of Method 521, mostly
because of questions on the scope and extent of interlaboratory testing
and validation. Commenters thought that methods that are already being
used by laboratories should be allowed under UCMR. Several commenters
gave specific suggestions as to which methods were commonly in use that
could be used for UCMR monitoring.
The methods developed by EPA, for this and other chemical methods
needs for the analysis of drinking water, were subjected to a rigorous
process that included a series of testing, validation studies and peer
review, which went beyond the proficiency testing or round robin study
of the alternative draft unpublished methods suggested by the
commenters. Each individual procedure of every method proposed by EPA
was subjected to rigorous testing for a minimum of two years using
scientifically sound procedures. EPA's review of the suggested
alternative draft methods also identified technical deficiencies that
preclude their approval for monitoring under UCMR 2.
6. Flame Retardants, Other Priority Contaminants, and Related Methods
a. This Rule
Under this rule, EPA is requiring monitoring for five flame
retardants, as well as terbufos sulfone and dimethoate, as part of List
1, Assessment Monitoring. The final rule also specifies EPA Method 527
for analysis of these compounds. There were no changes between the
proposed and final rule language regarding these priority contaminants
and their associated method.
b. Summary of Major Comments
Concern was raised through public comment that only one citation
was provided in the proposed rule preamble supporting the rationale for
choosing this group of contaminants. Public comment suggestions were
made that there may be other groups of contaminants, such as endocrine
disruptors, that would be a better choice than the flame retardants.
EPA notes that both Darnerud, 2001 and Hites, 2004 were cited in the
preamble of the proposed regulation as sources of the statements
concerning flame retardants. There are however, many additional
articles in the scientific literature which could have also been cited.
In an article entitled ``An overview of brominated flame retardants in
the environment'' by Cynthia A. deWit, which was published in
Chemosphere, 46 (2002), the author cites over 180 published articles on
flame retardants. In addition, three published articles; T.E. Stoker,
``Toxicology and Applied Pharmacology'', 207 (2005); T.A. McDonald,
``Chemosphere'', 46 (2002); and I.A.T.M. Meerts, ``Environmental Health
Perspectives'', 109 Vol. 4 (2001) concern tests that have been
performed which support that the flame retardants specified for
monitoring in UCMR 2 are endocrine disruptors.
7. Triazines Chlorodegradates and Parent Compounds
a. This Rule
In the proposed rule preamble, EPA solicited public comment
regarding three triazine chlorodegradates and three of their parent
compounds because the Agency is conducting a cumulative risk assessment
for the chlorodegradates as a group with atrazine, simazine, and
propazine. While atrazine and simazine are already regulated under
NPDWRs, EPA was considering UCMR monitoring for these parent compounds
concurrent with the collection of UCMR data for their degradation
products to determine the degree of correlation between the occurrence
of the parents and their degrades. Though public comment was requested,
triazines were not officially proposed for inclusion under UCMR 2
monitoring. There were no changes between the proposed and final rule
language, and thus, the triazines are not part of the UCMR 2 monitoring
requirements.
b. Summary of Major Comments
Commenter opinion varied regarding inclusion of triazines in UCMR 2
monitoring. For those that supported their inclusion, the primary
reason was health effects. One of these commenters also recommended
that cyanizine be included in this contaminant group. Of those who
opposed including this group, the following reasons were given:
[[Page 375]]
concern about laboratory capacity if two similar analyses using liquid
chromatography/tandem mass spectrometry (LC/MS/MS) were required to be
conducted in the same time frame; concern regarding the status of
method development; the belief that the manufacturer should pay for
occurrence testing; and the fact that information on the parent
compounds is already available.
Although validation of a new triazine method has been completed,
EPA agrees that requiring the use of two LC/MS/MS methods in the same
UCMR cycle could present a laboratory capacity problem. Due to these
concerns, EPA has concluded that triazine monitoring should be
postponed until a future cycle of the UCMR.
8. Other Compounds That Were Considered
a. This Rule
In identifying the target contaminants for this rule, EPA began
with a list of over 200 contaminants, compiled from a variety of
different sources, including: UCMR 1 reserved contaminants; CCL 1
deferred pesticides; CCL 1 suspected endocrine disruptors; and other
emerging contaminants. Through a multi-stepped review and
prioritization process, the list was narrowed and prioritized. EPA's
final prioritization was based on the available relative health effects
information for each compound.
b. Summary of Major Comments
EPA received comment encouraging the Agency to include some
endocrine disruptors on the UCMR 2 contaminant list. The initial list
that EPA compiled included several contaminants that were identified as
suspected endocrine disruptors during CCL 1 development, as well as
others that are widely suspected to be endocrine disruptors. EPA used a
multi-stepped review and prioritization process to select 25
contaminants for monitoring from the broader pool of 200 contaminants.
Several different health effects criteria were used to prioritize
contaminants in addition to endocrine disruption, such as cancer
classification and toxicity. Although some contaminants that are
considered endocrine disruptors are not part of the final monitoring
list, all five flame retardants that are part of UCMR 2 are suspected
endocrine disruptors. In addition, EPA will consider these other
contaminants for monitoring in future rounds of UCMR monitoring.
D. How Are Laboratories Approved for UCMR 2 Monitoring?
1. This Rule
The UCMR 2 laboratory approval process is designed to assess
whether laboratories meet the required equipment, laboratory
performance, and data reporting criteria. Laboratories wishing to
participate in UCMR 2 must contact EPA to be considered. This rule
requires laboratories to complete and submit their registration to EPA
by April 4, 2007 (i.e., within 90 days of final rule publication). To
be approved to conduct UCMR testing, this rule requires that the
laboratory be certified under Sec. 141.28 for one or more compliance
analyses; demonstrate, for each analytical method it plans to use for
UCMR testing, that it can meet the Initial Demonstration of Capability
(IDC) requirements and successfully participate in the UCMR Proficiency
Testing (PT) Program; and has the capability to post monitoring data to
EPA's electronic reporting system. Laboratories are encouraged to apply
for UCMR 2 approval as early as possible. The steps for the laboratory
approval process are as follows:
a. Request To Participate
The laboratory must contact EPA requesting to participate in the
UCMR 2 laboratory approval process. Laboratories must send this request
to: UCMR 2 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 began
accepting participation requests for the methods associated with UCMR 2
(including List 1, Assessment Monitoring, and List 2, Screening Survey)
following publication of the proposed rule on August 22, 2005. The
laboratory must complete and submit the necessary registration by April
4, 2007.
b. Registration
EPA will send each laboratory that requests a registration package
a list of information that EPA will need to process that application.
This registration information will provide EPA with the basic
information about the candidate laboratory including: Laboratory name;
mailing address; shipping address; contact name; phone number; fax
number; e-mail address; and UCMR 2 methods for which the laboratory is
seeking approval. Thus, the purpose of the registration step is to
ensure that EPA has all of the necessary contact information and that
each laboratory receives a customized application package, which will
include materials and instructions for the methods that it plans to
use.
c. Application Package
When EPA receives the registration information, an application
package will be sent to the laboratory for completion. This application
package will be customized to address only those EPA methods selected
in the laboratory's registration. EPA may provide analytical standards
to be used when conducting monitoring; however, laboratories will be
required to procure their own standards, where commercially available,
to be used to complete the application process. Information requested
in the application will include:
IDC data, including precision, accuracy, and MRL studies;
Information regarding analytical equipment;
Proof of current drinking water laboratory certification;
and
Example chromatograms for each method under review.
The laboratory must also confirm that it will post UCMR 2
monitoring results (on behalf of its PWS clients) to EPA's UCMR
electronic data reporting system.
d. EPA Review of Application Package
EPA will review the application package and, if necessary, request
follow-up information. Satisfactory completion of this portion of the
process will allow the laboratory to participate in the UCMR 2 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 must successfully analyze UCMR 2 PT sample(s) for each
method for which the laboratory is seeking approval. A laboratory must
pass only one PT for each of the UCMR 2 methods. Laboratories applying
for UCMR 2 approval, and laboratories conducting UCMR 2 analyses, may
be subject to on-site laboratory audits. No PT studies will be
conducted after the start of monitoring. Laboratories will not be
approved if they did not successfully complete a PT study.
f. Written EPA Approval
After the first five steps (a-e, above) have been successfully
completed, EPA will send the laboratory a letter listing the methods
for which approval is granted. These letters will also include a
reminder that the laboratory may be subject to on-site audits. A list
of
[[Page 376]]
laboratories approved for UCMR 2 will be posted to EPA's UCMR Web site:
https://www.epa.gov/safewater/ucmr/ucmr2/labs.html.
2. Summary of Major Comments
Several comments recommended that EPA continue to oversee the
laboratory approval process and offer PTs throughout the UCMR 2 period
to ensure that approved laboratories are maintaining data quality. EPA
notes that the laboratory approval process is meant to establish a list
of laboratories that have demonstrated their ability to perform the
Quality Assurance/Quality Control (QA/QC) requirements for UCMR 2
methods. EPA and its supporting contractor will be assisting candidate
laboratories to achieve the required proficiency during the laboratory
approval process. Once the approvals are completed, EPA does not intend
to invest the resources to maintain an ongoing laboratory monitoring
program. However, EPA will continue to provide technical assistance to
laboratories that request it. In addition, EPA will conduct a limited
number of on-site laboratory audits. PWSs also have a role to play in
data quality. In selecting a laboratory for conducting UCMR 2 analyses,
the PWS should consider the laboratory's commitment to data quality. As
a partner in the commitment to quality data, the PWS should request and
review the QC data associated with their UCMR 2 occurrence samples.
Public comments also expressed concern that there may not be
adequate time for laboratories to receive certification, resulting in
reduced laboratory capacity at the onset of monitoring. Recommendations
included: Adjusting monitoring schedules in instances of inadequate
laboratory capacity; conducting the laboratory approval process prior
to rule promulgation; and extending the deadline for laboratories to
report monitoring results. EPA began offering the first round of
preliminary laboratory PTs in mid-2006. Additional rounds were
conducted before and are scheduled to be conducted after promulgation
of the final regulation. EPA is confident that sufficient laboratory
capacity will be available, but will also closely evaluate the results
of these preliminary PTs.
In addition, this rule contains language that revises the Screening
Survey and Assessment Monitoring time frame to January 2008 through
December 2010. This revision extends the start date of UCMR 2
monitoring by 6 months from the proposed July 2007 start date and
allows the Screening Survey to be conducted across three years as
opposed to the two-year time frame that was proposed. This will allow
PWSs more time for UCMR 2 planning and budgeting and provide additional
assurance of sufficient laboratory capacity.
E. What Is A System's Responsibility Regarding the Use of Laboratories?
1. This Rule
Under this rule, systems selected to participate in monitoring will
be required to use laboratories that are approved by EPA for UCMR 2
monitoring (see Section III.D, above). Large systems must ensure that
the laboratories conducting their analyses meet UCMR 2 QC requirements
and post the data in EPA's electronic data reporting system within 120
days of the sample collection date.
2. Summary of Major Comments
Several comments were received regarding PWSs' responsibility for
laboratory compliance with QC and reporting requirements, indicating
that EPA should be responsible for ensuring laboratory compliance, as a
condition of certification.
PWSs have always been responsible for the quality of the results
produced by the laboratory they employ, whether that monitoring was
conducted in support of UCMR 1 or compliance monitoring under SDWA.
Large PWSs (serving greater than 10,000 people) must ensure that their
laboratories have received appropriate EPA approvals to conduct UCMR 2
methods and must ensure that laboratories follow the specific UCMR 2 QC
requirements. EPA recommends that laboratory requirements be addressed
in the contractual language between the PWS and laboratory. EPA's UCMR
Web site at: https://www.epa.gov/safewater/ucmr/ucmr2 provides
informational materials that PWSs can use to help them evaluate their
data. These materials include: a laboratory approval manual, the
analytical methods (each of which contain a table summarizing QC
requirements of that method), and a general reference guide designed to
help PWSs develop laboratory contracts.
F. What Specific Quality Control Requirements Must Be Followed?
1. Method Development Approach and Method Defined Quality