[Federal Register Volume 70, Number 161 (Monday, August 22, 2005)]
[Proposed Rules]
[Pages 49094-49138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16385]
[[Page 49093]]
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Part IV
Environmental Protection Agency
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40 CFR Part 141
Unregulated Contaminant Monitoring Regulation (UCMR) for Public Water
Systems Revisions; Proposed Rule
Federal Register / Vol. 70, No. 161 / Monday, August 22, 2005 /
Proposed Rules
[[Page 49094]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 141
[Docket No. OW-2004-0001; FRL-7954-8]
RIN 2040-AD93
Unregulated Contaminant Monitoring Regulation (UCMR) for Public
Water Systems Revisions
AGENCY: Environmental Protection Agency.
ACTION: Proposed rule.
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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 such a list for the first Unregulated Contaminant
Monitoring Regulation cycle (i.e., UCMR 1) and a revised approach for
UCMR implementation in the Federal Register dated September 17, 1999.
UCMR 1 established a three-tiered approach for monitoring contaminants
based on the availability of analytical methods and laboratory capacity
considerations. Today's proposed regulation meets the SDWA requirement
to publish a listing of unregulated contaminants every five years.
Today's action proposes the design for the second UCMR cycle. EPA
is proposing to require monitoring of 26 chemicals using nine different
analytical methods. UCMR 2 monitoring is proposed to occur during 2007-
2011.This proposed action builds on the established structure of UCMR 1
and proposes some changes to the rule design. The primary changes to
UCMR 1 include: Redesign of the Screening Survey for List 2
contaminants to increase the statistical strength of the sampling
results by incorporating additional PWSs; updates to the lists of
contaminants to be monitored and the analytical methods approved to
conduct that monitoring; revisions to the ``data elements'' required to
be reported; and some revisions to the implementation of the monitoring
program to reflect ``lessons learned'' during UCMR 1. A systematic
procedure for the determination of a Minimum Reporting Level (MRL) is
also being proposed.
Implementation of today's proposed action would benefit the
environment by providing EPA and other interested parties with
scientifically valid data on the occurrence of these contaminants in
drinking water, 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: Written comments must be postmarked by midnight, delivered by
hand, or electronically mailed on or before October 21, 2005.
ADDRESSES: Submit your comments, identified by Docket ID No. OW-2004-
0001, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Agency Web site: http://www.epa.gov/edocket. EDOCKET,
EPA's electronic public docket and comment system, is EPA's preferred
method for receiving comments. Follow the on-line instructions for
submitting comments.
E-mail: [email protected].
Mail: Send three copies of your comments and any
enclosures to: Water Docket, United States Environmental Protection
Agency, Mail Code 4101T, 1200 Pennsylvania Avenue, NW., Washington, DC
20460, Attention Docket ID No. OW-2004-0001. Commenters should use a
separate paragraph for each issue discussed. In addition, please mail a
copy of your comments on the information collection provisions to the
Office of Information and Regulatory Affairs, Office of Management and
Budget (OMB), Attn: Desk Officer for EPA, 725 17th St., NW.,
Washington, DC 20503.
Hand Delivery: Deliver your comments to Water Docket, EPA
Docket Center, Environmental Protection Agency, Room B102, 1301
Constitution Ave., NW., Washington, DC, Attention Docket ID No. OW-
2004-0001. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. OW-2004-0001.
EPA's policy is that all comments received will be included in the
public docket without change and may be made available online at http://www.epa.gov/edocket, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through EDOCKET, http://www.regulations.gov, or e-mail. The EPA EDOCKET and the http://www.regulations.gov Web sites are ``anonymous access'' systems, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through EDOCKET or http://www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit
EDOCKET on-line or see the Federal Register of May 31, 2002 (67 FR
38102 (USEPA, 2002c)).
Docket: All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket. Although listed in the index, some
information is not publicly available, i.e., CBI 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 in EDOCKET or in hard
copy at the Water Docket, EPA/DC, EPA West, Room B102, 1301
Constitution Avenue, NW., Washington, DC. This Public Reading Room is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the Water Docket is (202) 566-2426.
FOR FURTHER INFORMATION CONTACT: Gregory Carroll, 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) 569-7948; or
e-mail at [email protected]. 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 9 a.m. to 5 p.m. eastern time.
SUPPLEMENTARY INFORMATION:
[[Page 49095]]
I. General Information
A. Does This Action Apply to Me?
Entities regulated by this action are public water systems (PWSs).
All large community and non-transient non-community water systems
serving more than 10,000 people 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 with primary
enforcement responsibility (primacy) to administer the regulatory
program for PWSs under the Safe Drinking Water Act (SDWA) may
participate in the implementation of the second cycle of the
Unregulated Contaminant Monitoring Regulation (i.e., UCMR 2) through a
Partnership Agreement. These Primacy 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.
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Examples of potentially
Category regulated entities NAICS \a\
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State, local, & tribal States, local and tribal 924110
governments. governments that
analyze water samples
on behalf of public
water systems required
to conduct such
analysis; states, local
and tribal governments
that directly operate
community 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.
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\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 the EPA is now
aware may potentially be regulated by this action. Other types of
entities not listed in the table could also be regulated. To determine
whether your facility is regulated by this action, you should carefully
examine the definition of PWS in Sec. 141.2 of Title 40 of the Code of
Federal Regulations, and applicability criteria in Sec. 141.40(a)(1)
and (2) of today's proposed action. If you have questions regarding the
applicability of this action to a particular entity, consult the person
listed in the preceding FOR FURTHER INFORMATION CONTACT section.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting Confidential Business Information
Do not submit this information to EPA through EDOCKET, http://www.regulations.gov, or e-mail. Clearly mark the part or all of the
information that you claim to be confidential business information
(CBI). For CBI information in a disk or CD-ROM that you mail to EPA,
mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for Preparing Your Comments
When submitting comments, remember to:
Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
Describe any assumptions and provide any technical
information and/or data that you used.
If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
Provide specific examples to illustrate your concerns, and
suggest alternatives.
Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
Make sure to submit your comments by the comment period
deadline identified.
Abbreviations and Acronyms
245-HBB 2,2',4,4',5,5'-hexabromobiphenyl
[mu]g/L Microgram per liter
ADI Acceptable daily intake
ASDWA Association of State Drinking Water Administrators
ATSDR Agency for Toxic Substances and Disease Registry
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
CBI Confidential Business Information
CCL Contaminant Candidate List
CF Concentration fortified
CFR Code of Federal Regulations
CWS Community water system
DBP Disinfection Byproduct
DBPR Stage 1 Disinfection Byproducts Rule
DEA Desethylatrazine
DACT Diaminochlorotriazine or Desethyldesisopropylatrazine.
DIA Desisopropylatrazine
DQO Data quality objective
DSMRT Distribution system maximum residence time
EPA United States Environmental Protection Agency
EPTDS Entry point to the distribution system
ESA Ethane sulfonic acid
FACA Federal Advisory Committee Act
FR Federal Register
FS Field sample
g/kg Gram per kilogram
GWUDI Ground water under the direct influence of surface water
HRPIR Half range prediction interval of results
HSDB Hazardous Substances Database
[[Page 49096]]
IARC International Agency for Research on Cancer
ICR Information collection request
IDC Initial demonstration of capability
IRIS Integrated Risk Information System
LCMRL Lowest concentration minimum reporting level
LD50 Median lethal dose
LFSM Laboratory fortified sample matrix
LFSMD Laboratory fortified sample matrix duplicate
MCL Maximum contaminant level mg/kg Milligram per kilogram
mg/kg/day Milligram per kilogram per day mg/L Milligram per liter
MRL Minimum reporting level
NCOD National Drinking Water Contaminant Occurrence Database
NDBA N-nitroso-di-n-butylamine
NDEA N-nitroso-diethylamine
NDMA N-nitroso-dimethylamine
NDPA N-nitroso-di-n-propylamine
NMEA N-nitroso-methylethylamine
NPDWR National Primary Drinking Water Regulation
NPYR N-nitroso-pyrrolidine
NTNCWS Non-transient non-community water system
NTTAA National Technology Transfer and Advancement Act
OA Oxanilic acid
OMB Office of Management and Budget
ORD Office of Research and Development
PA Partnership agreement
PBB Polybrominated biphenyls
PBDE Polybrominated diphenyl ethers pH Negative log of the hydrogen ion
concentration
PIR Prediction interval of results
PT Proficiency testing
PWS Public water system
PWSID Public water system identification
QC Quality control
RDX Hexahydro-1,3,5-trinitro-1,3,5-triazine
RED Reregistration Eligibility Decision
RFA Regulatory Flexibility Act
RfD Reference dose
RPD Relative percent difference
SBA Small Business Administration
SDWA Safe Drinking Water Act
SRF State Revolving Fund
TBBPA Tetrabromobisphenol A
TDI Tolerable daily intake
TNT 2,4,6-trinitrotoluene
TRI Toxics Release Inventory
UCMR Unregulated Contaminant Monitoring Regulation
UMRA Unfunded Mandates Reform Act of 1995
USGS United States Geological Survey
USEPA United States Environmental Protection Agency
Table of Contents
I. General Information
A. Does This Action Apply to Me?
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting Confidential Business Information
2. Tips for Preparing Your Comments
II. Statutory Authority and Background
A. What Is the Statutory Authority for UCMR?
B. How Does EPA Meet These Statutory Requirements?
C. How Are the Contaminant Candidate List, the National
Contaminant Occurrence Database, and the UCMR Interrelated?
III. Requirements of the Unregulated Contaminant Monitoring Program
A. What Priority Contaminants Were Selected for UCMR 2?
1. Compilation of Initial List of UCMR 2 Candidates
2. Establishing Priorities for UCMR 2
a. Health Effects Prioritization Approach.
b. Selections Based on UCMR 1 Reserved Contaminants List.
i. Alachlor ethane sulfonic acid (ESA) and Other Degradation
Products of Acetanilide Pesticides--List 2.
ii. Explosives--List 1.
c. Selections from UCMR 1 Contaminants List.
d. Selection of Emerging Contaminants.
i. Nitrosamines--List 2.
ii. Others Identified in CCL 1 Process and Recent Reviews of
Information on Emerging Contaminants--List 1.
3. Other Considerations in Selecting Contaminants
a. Triazine Chlorodegradates and Parent Compounds.
b. Other Contaminants Considered.
B. What Analytical Methods Will Be Used for Monitoring?
C. How Were These Analytical Methods Developed?
D. How Were Minimum Reporting Levels Determined?
E. How Will Laboratories Conduct UCMR Analyses?
1. Laboratory Approval Process for UCMR 2
a. Request to Participate.
b. Registration.
c. Application Package.
d. EPA Review of Application Package.
e. Proficiency Testing.
f. Written EPA Approval.
2. Quality Control Requirements
F. How Are Systems Selected for UCMR Monitoring?
1. How Are Systems Selected for Assessment Monitoring?
a. Original Assessment Monitoring Statistical Approach for UCMR
1.
b. Proposed Assessment Monitoring Statistical Approach for UCMR
2.
2. How Are Systems Selected for the Screening Survey?
a. Original Screening Survey Statistical Approach for UCMR 1.
b. Proposed Screening Survey Statistical Approach for UCMR 2.
3. What Is UCMR Pre-Screen Testing?
4. What Are the Other Applicability Considerations?
a. New Applicability Date.
b. Notice Regarding Changes to Applicability Required.
c. Definition of System Population.
G. When Must Monitoring Be Conducted?
1. Timing of Monitoring
2. Individual PWS Monitoring Schedules
H. Where Are Samples Collected?
I. What Is the States' Role in the UCMR Program?
1. State Participation in Partnership Agreements (PAs)
2. Activities To Be Included in the UCMR 2 PAs
a. Review and Revision of the Initial State Monitoring Plan.
b. Review and Approval of PWS Proposed Representative EPTDS.
c. Notification and Instructions for Systems.
3. What If States Do Not Participate in a PA?
J. What Are the Data Reporting Requirements?
1. What Information Is Required Prior to Monitoring?
a. Contact Information.
b. Sampling Location and Inventory Information.
c. Proposals for Ground Water Representative Sampling Locations.
2. When Must Monitoring Results Be Reported?
a. Large Systems.
b. Small Systems.
3. What Data Elements Are Required with the Monitoring Results?
a. New Data Elements.
b. Unchanged Data Elements.
c. Modified Data Elements.
d. Data Elements No Longer Reported.
K. Time Line of UCMR Activities
1. Assessment Monitoring
2. Screening Survey
IV. Cost and Benefits of Today's Proposed Action
V. Technical Corrections
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
VII. Public Involvement in Regulation Development
VIII. References
PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS
Sec. 141.24 Organic chemical, sampling and analytical requirements.
[[Page 49097]]
Sec. 141.35 Reporting for unregulated contaminant monitoring.
(a) General applicability.
(b) Reporting by all systems.
(1) Where to submit UCMR reporting requirement information.
(2) Contacting EPA if your system does not meet applicability
criteria or has status change.
(c) Reporting by large systems.
(1) Contact information.
(2) Sampling location and inventory information.
(3) Proposed ground water representative sampling locations.
(i) Qualifications.
(ii) Demonstration.
(iii) Approval.
(4) Contacting EPA if your PWS has not been notified of
requirements.
(5) Notifying EPA if your PWS cannot sample according to
schedule.
(6) Reporting monitoring results.
(i) Electronic reporting system.
(ii) Reporting schedule.
(7) Only one set of results accepted.
(8) No reporting of previously collected data.
(d) Reporting by small systems.
(1) Contact information.
(2) Reporting sampling information.
(e) Data elements.
Sec. 141.40 Monitoring requirements for unregulated contaminants.
(a) General applicability.
(1) Applicability to transient non-community systems.
(2) Applicability to community water systems and non-transient
non-community water systems.
(i) Large systems.
(ii) Small systems.
(3) Analytes to be monitored.
(4) Sampling requirements.
(i) Large systems.
(ii) Small systems.
(5) Quality control requirements.
(i) Sample collection/preservation.
(ii) Laboratory approval for Lists 1 and 2.
(iii) Minimum Reporting Level.
(iv) Laboratory fortified sample matrix and laboratory fortified
sample matrix duplicate.
(v) Detection Confirmation.
(vi) Method defined quality control.
(vii) Reporting.
(6) Violation of this rule.
(i) Monitoring violations.
(ii) Reporting violations.
(b) Requirements for State and Tribal participation.
(1) Governors' petition for additional contaminants.
(2) State-wide waivers.
(i) Application.
(ii) Approval.
List of Exhibits and Tables
Preamble
Exhibit 1: Proposed Contaminant List and Sampling Design
Exhibit 2: Summary of Proposed Major Changes to UCMR 1
Exhibit 3: Median Lethal Dose and Corresponding Toxicity Ranking
Exhibit 4: Comparison of Acetanilide Herbicides Use
Exhibit 5: Analytes Included in the Explosives Method (EPA 529)
Exhibit 6: Analytical Methods Proposed for UCMR 2 Monitoring
Exhibit 7: Approximate Sample Allocation for Assessment Monitoring:
Expected Number of Systems Selected by System Size and Water Source
Exhibit 8: UCMR 1 Design Allocation of Systems for Screening
Surveys, by Size Category
Exhibit 9: Allocation of Systems for Screening Survey, List 2
Contaminants
Exhibit 10: Time Line of UCMR Activities
Exhibit 11: Systems To Participate in UCMR 2 Monitoring
Exhibit 12: Number of Publicly- and Privately-Owned Systems Subject
to UCMR 2
Exhibit 13: EPA and Small Systems Costs for Implementation UCMR 2
Exhibit 14: UCMR 2 Relative Cost Analysis for Publicly-Owned Systems
(2007-2011)
Exhibit 15: UCMR 2 Relative Cost Analysis for Privately-Owned
Systems (2007-2011)
Sec. 141.35
Table 1. Unregulated Contaminant Monitoring Reporting Requirements
Sec. 141.40
Table 1. UCMR Contaminant List
Table 2. Monitoring Frequency by Contaminant and Water Source Types
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)
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)
issue a new list of no more than 30 unregulated contaminants to be
monitored by PWSs, and that EPA enter the monitoring data into a
national contaminant occurrence database. EPA's UCMR program must
ensure that only a national representative sample of public water
systems (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 systems served, 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,
1999c)). 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, 2000a); 66 FR 2273,
January 11, 2001 (USEPA, 2001a); and 67 FR 65888, October 29, 2002
(USEPA, 2002d).\1\ 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. Today's action fulfills this
statutory obligation, identifying 26 priority contaminants for
monitoring using nine proposed analytical methods. To comply with SDWA,
EPA has developed a proposed contaminant list (Exhibit 1) and sampling
design for UCMR 2 (2007-2011) with input from both stakeholders and an
EPA working group.
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\1\ Additional technical corrections to the rule, as well as
adjustments to the initial reporting process, were published
including: May 16, 2001 (66 FR 27215 (USEPA, 2001b)); September 4,
2001 (66 FR 46221 (USEPA, 2001d)); and March 12, 2002 (67 FR 11043
(USEPA, 2002b)). In total, these rules and revisions constitute the
``UCMR 1.'' This amendment to establish new contaminants for
monitoring during the second five-year cycle is referred to as
``UCMR 2.''
Exhibit 1.--Proposed Contaminant List and Sampling Design
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List 1. Assessment Monitoring
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1,3-dinitrobenzene........................ 2,4,6-trinitrotoluene (TNT).
2,2',4,4'-tetrabromodiphenyl ether (BDE- Dimethoate.
47).
2,2',4,4',5-pentabromodiphenyl ether (BDE- Hexahydro-1,3,5-trinitro-
99). 1,3,5-triazine (RDX).
2,2',4,4',5,5'-hexabromobiphenyl (245-HBB) Terbufos sulfone.
2,2',4,4',5,5'-hexabromodiphenyl ether Perchlorate.
(BDE-153).
[[Page 49098]]
2,2',4,4',6-pentabromodiphenyl ether (BDE- ............................
100).
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List 2. Screening Survey
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Acetochlor................................ Metolachlor OA.
Acetochlor ESA............................ N-nitroso-diethylamine
(NDEA).
Acetochlor OA............................. N-nitroso-dimethylamine
(NDMA).
Alachlor.................................. N-nitroso-di-n-butylamine
(NDBA).
Alachlor ESA.............................. N-nitroso-di-n-propylamine
(NDPA).
Alachlor OA............................... N-nitroso-methylethylamine
(NMEA).
Metolachlor............................... N-nitroso-pyrrolidine
(NPYR).
Metolachlor ESA........................... ............................
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The UCMR for the first cycle of monitoring (i.e., UCMR 1)
established a three-tiered approach for monitoring contaminants based
on the availability of analytical methods. Assessment Monitoring
contaminants on List 1 (UCMR 1) could be analyzed using analytical
methods that were in common use in drinking water laboratories.
Screening Survey contaminants on List 2 (UCMR 1) could only be analyzed
using newly developed analytical methods that were not in common use in
drinking water laboratories. Laboratory capacity to perform these
analyses was therefore limited. No analytical methods were available to
monitor for the Pre-Screen Survey contaminants on List 3 (UCMR 1),
although the regulation allowed for the possibility of such methods
becoming available during the cycle.
EPA has developed the design for the second UCMR cycle (i.e., UCMR
2). EPA is building upon the established structure of UCMR 1, and
proposing some changes to the rule design, based upon lessons learned
during the UCMR 1 cycle. The design of UCMR 2 is summarized below,
including a discussion of the changes proposed for UCMR 2, and the
reasons for those proposed changes.
Assessment Monitoring (i.e., List 1) 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. EPA is proposing that Assessment
Monitoring be required for all large water systems (those serving more
than 10,000 people), and for a nationally representative sample of 800
small water systems (those serving 10,000 or fewer people), during a
continuous 12-month period during July 2007 through June 2010 quarterly
for surface water systems, and twice, at 6-month intervals for ground
water systems). Systems subject to UCMR 2 include community water
systems (CWSs) and non-transient non-community water systems (NTNCWSs),
except those systems that purchase all of their finished water from
another PWS.
EPA designed the sampling frame for the national sample of small
systems to ensure that UCMR 2 sampling results would yield a high level
of confidence and a low margin of error. To attain the representative
sample, EPA is proposing that small systems be stratified by water
source type (ground or surface water), service size category, and State
(each allocated a minimum of two systems). With monitoring data from
all large PWSs (a census of all 3,110 large systems) and a
statistically representative sample of 800 small PWSs (for a total of
approximately 3,910 systems), List 1 Assessment Monitoring provides
sample data suitable for national population exposure assessments.
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 and, therefore, laboratory capacity may be
insufficient to conduct the larger scale Assessment Monitoring. EPA is
proposing that a Screening Survey be conducted by approximately 320
PWSs serving more than 100,000 people (i.e., 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.
Screening Survey systems will be required to monitor during a
continuous 12-month period during July 2007 through June 2009 quarterly
for surface water systems, and twice, at 6-month intervals, for ground
water systems). With a total of over 1,100 systems participating in the
Screening Survey, sufficient data will be generated to provide an
overall national estimate of population exposure.
The third tier of UCMR 2 is called Pre-Screen Testing. Pre-Screen
Testing is envisioned for use with methods that are in the early stages
of development, and/or methods that are very specialized or limited in
applicability. It is designed to be conducted by up to 200 PWSs that
would be identified by State agencies as vulnerable to the List 3
contaminants. This would be a targeted sampling to assess occurrence in
the most vulnerable settings, and could help to guide the next steps
for contaminant evaluation and methods development. EPA is not
proposing any Pre-Screen Testing in today's action.
C. How Are the Contaminant Candidate List, the National Contaminant
Occurrence Database, and the UCMR Interrelated?
The UCMR program was developed in coordination with the Contaminant
Candidate List (CCL) and the National Drinking Water Contaminant
Occurrence Database (NCOD). 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. The data collected through the UCMR program is being stored
in the 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
[[Page 49099]]
viewed by the public at EPA's UCMR Web site: http://www.epa.gov/safewater/ucmr/data.html. The second CCL was published in February 2005
and carried over many of the unregulated contaminants from CCL 1, for
which research is ongoing (70 FR 9071, February 24, 2005 (USEPA, 2005).
III. Requirements of the Unregulated Contaminant Monitoring Program
EPA has developed, and is proposing in today's action, a revised
design for UCMR 2 based on experience with UCMR 1. In addition to
requesting comments on the list of UCMR 2 contaminants, EPA is also
requesting comments on the Agency's specification of minimum reporting
levels (MRLs) and the procedure to establish them. Other changes for
which EPA is requesting comment include modifications or clarifications
to the systems required to monitor, the timing and location of
monitoring, and the reporting process. Today's proposed modifications
to the rule also incorporate lessons learned during the course of UCMR
1 implementation. Throughout UCMR 1, EPA worked with States, regulated
PWSs, and analytical laboratories in addressing implementation and
regulatory requirements. EPA reviewed various aspects of the UCMR 1
program and identified several critical changes that will improve
implementation. The specific approach that EPA is proposing for UCMR 2,
along with the rationale for any changes, is described in this section.
Exhibit 2 provides a list of the substantive changes to UCMR 1
being proposed in today's action. EPA invites the public to comment on
these changes to the UCMR program. Instructions for submission of
public comments are provided in the ADDRESSES section of this preamble.
Key aspects of the UCMR program that remain the same include direct
implementation of the rule by EPA, the design of Assessment Monitoring,
and EPA funding for the small system testing (i.e., for those systems
serving 10,000 or fewer people).
Although EPA is republishing the entire text of 40 CFR 141.35 and
40 CFR 141.40 of today's action for readability purposes, EPA is not
reproposing for public comment aspects of the rule that are unchanged
from the 1999 UCMR 1. The unchanged aspects of UCMR 1 include: (1) The
design of Assessment Monitoring (for List 1 contaminants), except for
the elimination of Index Systems, and Pre-Screen Testing (for List 3
contaminants); (2) the frequency of sampling; (3) the requirement to
resample when a sampling error occurs; (4) use of the largest
concentration when duplicate samples are reported; (5) the requirements
for laboratories to enter monitoring data, and large PWSs to approve
and submit data using EPA's electronic data reporting system; (6)
reporting of PWS contacts; (7) the definition of violations; (8) the
opportunity for State and Tribes to enter into Partnership Agreements;
(9) the Governors' petition process; and (10) the State-wide waiver
provision. EPA is not seeking, and will not respond to comments on
parts of the UCMR that are unchanged under today's action.
Exhibit 2.--Summary of Proposed Major Changes to UCMR 1
------------------------------------------------------------------------
Change Preamble Rule
------------------------------------------------------------------------
New list of 26 priority Contaminants: Sec.
contaminants, and 9 analytical III.A.; 141.40(a)(3).
methods. Analytical
Methods: III.B.;
III.C.
Modified laboratory approval III.E.1........... Sec.
program. 141.40(a)(5)(ii)-
(vi).
QC requirements: Detection limit III.E.2........... Sec. Sec.
would be replaced by MRL; No 141.40(a)(5)(iii)
longer required to analyze a -(v).
field reagent blank or QC
sample.
Changes in timing for posting III.E.2; III.J.2.. Sec.
and approval of monitoring data. 141.35(c)(6)(ii);
Sec.
141.40(a)(5)(vii)
.
Elimination of Index systems.... III.F.1.b......... Sec.
141.40(a)(2)(ii)(
C).
More systems to monitor for III.F.2........... Sec.
Screening Survey. 141.40(a)(2)(i)(B
); Sec.
141.40(a)(2)(ii)(
B).
Screening Survey monitoring to III.F.2.b; III.K.2 Sec.
be conducted across 2 years. 141.40(a)(3).
Establishment of date for rule III.F.4........... Sec. 141.35(a);
applicability; Clarification of Sec. 141.40(a).
system population definition.
Large systems must submit III.J.1.a......... Sec.
contact and sampling location 141.35(b)(1).
information.
Large system monitoring will be III.G.2........... Sec.
scheduled by EPA with allowance 141.35(c)(5);
for systems to change schedule Sec.
if needed. 141.40(a)(4)(i).
All samples collected at EPTDSs; III.H; III.J.1.b.. Monitor at EPTDS
nitorsamines samples for PWSs and DSMRT
subject to Stage 1 D/DBP Rule locations: Sec.
collected at DSMRT and EPTDS 141.40(a)(3);
locations; Representative EPTDS Sec.
proposals by PWSs with multiple 141.40(a)(4)(i)(C
ground water EPTDSs. ); Sec.
141.40(a)(4)(ii)(
B).
EPTDS proposal:
Sec.
141.35(c)(3).
Changes to data elements........ III.J.3........... Sec. 141.35(e).
------------------------------------------------------------------------
Acronyms: QC = quality control; MRL = minimum reporting level; PWS =
public water system; EPTDS = entry point to the distribution system; D/
DBP Rule = Stage 1 Disinfectant/Disinfection Byproducts Rule; DSMRT =
distribution system maximum residence time; UCMR = Unregulated
Contaminant Monitoring Regulation.
A. What Priority Contaminants Were Selected for UCMR 2?
1. Compilation of Initial List of UCMR 2 Candidates
With public health protection as its top priority, EPA has drawn
upon several different sources in developing the proposed UCMR 2
contaminant list. In the early stages of list development, EPA began by
identifying a broad list of over 200 contaminants. This information and
rationale was first presented at a public stakeholder meeting held on
October 29, 2003, within a draft discussion document titled: ``UCMR 2:
Contaminant Selection Rationale'' (USEPA, 2003e). The following sources
were used to identify potential UCMR 2 contaminants:
UCMR 1 ``reserved'' contaminants (CCL 1 occurrence
priorities): Includes those contaminants identified as priorities in
the September 1999 UCMR (64 FR 50556 (USEPA, 1999c)), but reserved for
later monitoring because methods were not yet available. By design,
most of the UCMR 1 contaminants were selected from the list of CCL 1
contaminants that required the
[[Page 49100]]
collection of additional occurrence data and for which analytical
methods were available (63 FR 10274 (USEPA, 1998b)).
Other UCMR 1 contaminants: Includes several contaminants
that were monitored under UCMR 1 and were identified as potential UCMR
2 priorities because Screening Survey results indicate the need for
more information, or because improved analytical methods for these
contaminants have been developed since the last cycle.
CCL 1 ``deferred pesticides'': Includes a list of priority
pesticides ranked by chemical properties, occurrence, and use that EPA
identified. EPA decided to ``defer'' certain pesticides for later
consideration pending further evaluation of these pesticides to
determine if they occur at levels of health concern (62 FR 52194,
October 6, 1997 (USEPA, 1997)). EPA plans to consider the deferred
pesticides in the context of an improved approach for selecting
contaminants for future CCLs. This will enable the Agency to consider
these contaminants in a consistent, reproducible manner with a wide
range of other contaminants.
CCL 1 suspected endocrine disruptors: Includes a list of
chemicals that were suspected of having adverse effects on endocrine
function (62 FR 52194, October 6, 1997 (USEPA, 1997)) that EPA
identified during the development of CCL 1. For certain suspected
endocrine disruptors for which little information was available, EPA
decided to wait for further study to reconsider these contaminants in
the future. As with pesticides, EPA believes that suspected endocrine
disruptors should be considered in the context of an improved approach
for selecting contaminants for future CCLs. This enables the Agency to
use a more refined and improved approach in evaluating these
contaminants.
Other emerging contaminants: Includes additional
contaminants of concern based on current research on occurrence and
relative health effects risk factors, and whether the contaminants
could be identified by analytical methods used in measuring other
priority UCMR contaminants.
2. Establishing Priorities for UCMR 2
Of the 200-plus contaminants initially identified, EPA retained
only those contaminants that met the following criteria: (1) Pesticides
on the list must be currently registered for use in the United States;
(2) all contaminants must have an analytical reference standard (pure
compound) available; and (3) the analytical method must be available.
Based on these criteria, the list was reduced to approximately 127
contaminants.
EPA further prioritized this list of contaminants as follows. The
relative health effects screening was considered as part of EPA's
identification of contaminants for monitoring under UCMR 2 (the
relative effects screening and prioritization process is discussed and
explained in next section). Through this prioritization process, 26
contaminants have been identified for UCMR 2 monitoring. At the current
time, EPA does not expect to add contaminants to reach the statutory
maximum of 30 contaminants. However, if other emerging contaminant(s)
advance in importance during the first part of UCMR 2 monitoring, EPA
will consider an amendment that would add up to four additional
contaminants for monitoring in a later phase of the cycle. The
remainder of this section discusses the specific selection of
contaminants that EPA is proposing for UCMR 2 monitoring.
a. Health Effects Prioritization Approach. In identifying
contaminants for monitoring under the UCMR program, potential human
health effects are an important consideration. Therefore, after
compiling a broad list of potential UCMR contaminants, EPA's next step
was to develop a process to prioritize these contaminants by estimating
their relative adverse health effects. EPA first collected existing
health effects information, including Reference Dose (RfD), Tolerable
Daily Intake (TDI), Acceptable Daily Intake (ADI), Cancer Unit Risk,
Cancer Classification, and Median Lethal Dose (LD50). Using
this information, EPA developed a screening system to rank contaminants
into high, medium, and low relative priorities.
In developing the relative rankings, EPA recognized two tiers of
data for the assessment of non-cancer toxicity, based on applicability
to human health effects: (1) RfD (and its equivalents); and (2)
LD50. The RfD and equivalent measures such as TDI and ADI
are doses that are expected to have no measurable health effects on the
human population, including sensitive populations. These levels are
based on expert judgment of the available research data. The
LD50, on the other hand, is the result of observation of
effects in experimental studies (i.e., the concentration at which 50%
of experimental animals die) and has not been extrapolated for
application to human populations. Many compounds have measured
LD50 values, but significantly fewer have calculated RfDs.
In prioritizing compounds for inclusion in UCMR, EPA refers to RfD (and
equivalent data) as ``potency data'', while LD50 data are
referred to as ``toxicity data.''
As with the two tiers of data for non-cancer toxic effects, cancer
information is analogously divided into two tiers. The higher tier of
data, known as ``Unit Risk,'' represents the risk of developing cancer
from a given drinking water concentration. The second tier of data, the
``Cancer Classification,'' categorizes the likelihood of a compound
contributing to the human cancer burden and is a purely qualitative
measure. Thus, it is generally less informative than Unit Risk data.
RfDs were typically obtained from EPA's Integrated Risk Information
System (IRIS) or the Office of Pesticide Programs' Reregistration
Eligibility Decisions (REDs). The ADIs were typically identified
through the International Programme on Chemical Safety or the European
Agency for the Evaluation of Medicinal Products Web sites. TDIs were
identified through World Health Organization and the Netherlands
Institute of Health Sciences sources. If an RfD or equivalent could not
be identified, attempts were made to obtain an oral LD50 or
other relevant information from sources such as the Hazardous
Substances Database (HSDB) and primary literature. Cancer Unit Risk
information was typically obtained from IRIS or REDs, while cancer
classifications were found in IRIS, REDs, and from the International
Agency for Research on Cancer (IARC).
To develop a ranking for each contaminant, compounds with potency
data were assigned values from 1 to 10 based on equations derived
empirically from the distribution of RfDs for the compounds listed on
IRIS. Details concerning the derivations of these equations are
contained in a support document titled ``Estimating Potency Scores: An
Exercise'' (USEPA, 2004h). Contaminant prioritization estimates were
discussed at a public stakeholder meeting held on October 29, 2003; the
estimates are contained in an additional support document titled:
``UCMR 2: Contaminant Selection Rationale'' (USEPA, 2003e). One
equation was derived for RfD and equivalent data, and one for cancer
Unit Risk data. The distribution of RfD values was log-normally
distributed, and the following equation was used to score compounds:
Non-cancer risk = 10-(rounded log10 RfD + 7)
To score compounds on a relative scale of 1 to 10, EPA examined the
distribution of unit risks for the compounds found in the ``2002
Drinking Water Standards and Health
[[Page 49101]]
Advisories'' (USEPA, 2002a), and used the following equation:
Cancer Risk = 10-((rounded log10 10-\4\ cancer
risk) + 6)
Contaminants with resulting scores from each of these equations of 1-3
were considered relatively lower priority, those with scores of 4-6
were considered of medium relative priority, and scores of 7-10 were
considered to be of high relative priority. In the case of compounds
for which both cancer and non-cancer data were available, the data
associated with the highest relative score were used for
prioritization.
Compounds with toxicity data were ranked by a separate system based
on LD50, and this ranking was modified by cancer
classification where possible. Exhibit 3 summarizes the criteria that
were used to rank compounds by LD50.
Exhibit 3.--Median Lethal Dose and Corresponding Toxicity Ranking
------------------------------------------------------------------------
Relative toxicity ranking LD50 data
------------------------------------------------------------------------
Very High................................. <=1 mg/kg \1\
High...................................... >1 mg/kg- <=50 mg/kg
Moderate.................................. >50 mg/kg- <=500 mg/kg
Slight.................................... >500 mg/kg- <=5 g/kg \2\
------------------------------------------------------------------------
\1\ mg/kg = milligram per kilogram.
\2\ g/kg = gram per kilogram.
Additionally, if a chemical meeting the ``slight'' criteria was
also noted as ``possibly carcinogenic to humans'' (Group 2B), the
chemical was moved up one level to ``moderate.'' For example,
2,2',4,4',5,5'-hexabromobiphenyl toxicity should be categorized as
slight based on an identified oral LD50 in rats of 21,500
milligrams per kilogram (mg/kg). However, because IARC categorized this
chemical as ``possibly carcinogenic to humans,'' it now is categorized
as moderate.
b. Selections Based on UCMR 1 Reserved Contaminants List. One of
EPA's priorities for UCMR 2 is to monitor for contaminants that were
identified as priorities for monitoring during UCMR 1, but were
``reserved'' because analytical methods were not available at the time.
Applying these criteria, two UCMR 1 ``reserved'' contaminants are
priorities for UCMR 2: alachlor ethane sulfonic acid (alachlor ESA)
(and other acetanilide pesticide degradation products) and hexahydro-
1,3,5-trinitro-1,3,5-triazine (RDX), an explosive. The first is a
contaminant group that is comprised of multiple contaminants, as
further discussed in this section. Both alachlor ESA (and other
degradation products of acetanilide pesticides) and RDX were included
on UCMR 1, List 2, but because the required analytical methods were not
available in time for UCMR 1 monitoring they were listed as
``reserved.''
i. Alachlor ethane sulfonic acid (ESA) and Other Degradation
Products of Acetanilide Pesticides--List 2.
Based on the rationale provided below, EPA is proposing that the
following six degradation products of acetanilide pesticides and their
parent compounds be part of the UCMR 2, List 2, Screening Survey
monitoring:
Acetochlor
Acetochlor ESA
Acetochlor OA
Alachlor
Alachlor ESA
Alachlor OA
Metolachlor
Metolachlor ESA
Metolachlor OA
The proposed List 2 analytes include the ethane sulfonic acid (ESA)
and oxanilic acid (OA) degradation products of the three highest-use
parent acetanilide compounds: metolachlor, alachlor, and acetochlor
(see Exhibit 4). In addition, EPA is proposing that List 2 include the
parent compounds, acetochlor, alachlor and metolachlor, because one
possible option for regulating these compounds and their degradates
would be to establish maximum contaminant levels (MCLs) for the total
of each parent plus its respective metabolites.
There are a number of reasons why EPA has prioritized alachlor ESA
(and other degradation products of acetanilide pesticides) for
inclusion in UCMR 2 monitoring. This group of acetanilide degradation
products was originally listed under the CCL 1 occurrence priorities
and then included as part of UCMR 1, List 2 as ``reserved''; thus the
group is a top priority for UCMR 2 monitoring. In addition, ambient
water monitoring data indicate that occurrence of the acetanilide
degradation products (ESA and OA) is more widespread than that of the
parent compounds.
Inclusion of the parent acetanilides on List 2 monitoring will
potentially allow EPA to learn more about the extent of decomposition
of the parent compounds, and about levels of co-occurrence of the
parents and their degradation products. The parent acetanilides are
widely used herbicides applied for weed control on corn, soybean, and
other crops (see Exhibit 4). Acetochlor and metolachlor were both
included on the final CCL 1 priority list. Acetochlor was identified as
a CCL 1 occurrence priority, and was monitored under UCMR 1, List 1,
Assessment Monitoring. Metolachlor and its degradation products were
identified in the list of candidates for regulatory determination under
the CCL 1 prioritization process. However, EPA has since determined
that available health effects and occurrence information were
insufficient to support a regulatory determination.
Health effects studies have shown that chronic oral exposure to
parent acetanilide herbicides may have effects such as increased
salivation, decreased body weight, cellular/kidney/testicular
pathology, enlarged liver, and anemia in animal subjects (USEPA,
2003d). RfDs established by EPA for these parent herbicides are 0.01
milligrams per kilograms per day (mg/kg/day) for alachlor, 0.02 mg/kg/
day for acetochlor, and 0.15 mg/kg/day for metolachlor (USEPA, 2003d).
Based on animal studies, the carcinogenic potentials of the parent
acetanilide herbicides in humans are estimated to be: acetochlor and
metolachlor, ``possible carcinogen'' (59 FR 13654, March 23, 1994
(USEPA, 1994); 61 FR 10681, March 15, 1996 (USEPA, 1996a); and USEPA,
2003d); and alachlor, ``probable carcinogen'' (USEPA, 2004a). The NPDWR
for alachlor includes an maximum contaminant level goal of zero (due to
classification as a probable carcinogen) and an MCL of 0.002 milligrams
per liter (mg/L). EPA notes that alachlor is currently regulated under
the National Primary Drinking Water Standards. EPA is proposing the
collection of alachlor occurrence data in UCMR 2 concurrent with the
collection of data for the alachlor degradation products to determine
the degree of correlation between the parent compound and degradate
occurrence.
[[Page 49102]]
Exhibit 4.--Comparison of Acetanilide Herbicides Use \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
~1991-1995 ~1995-1998
~Early 1990s ~1992 annual ~1997 annual annual use annual use
Compound Year annual use use (million lb use (million lb (million lb (million lb
registered (million lb a.i.) -NCFAP a.i.) -NCFAP a.i.) -USGS a.i.) -USGS
a.i.) -EPA \2\ \3\ \4\ \4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Metolachlor....................................... 1976 59 59.4 67.3 57.9 66.9
(1987-1993)
Alachlor.......................................... 1969 29.3-44.6 51.6 15.2 25.7 15.1
(1993-1995)
Acetochlor........................................ 1994 -- -- 32.6 23.8 32.6
Propachlor........................................ 1964 2.1 4.3 0.9 3.9 0.9
(1987-1996)
Dimethenamid...................................... 1993 -- -- 6.0 2.6 6.0
Flufenacet........................................ 1998 -- -- -- -- --
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ ``--'' = substance not in use; a.i. = active ingredient.
\2\ EPA: http://cfpub.epa.gov/oppref/rereg/status.cfm?show=rereg.
\3\ National Center for Food and Agricultural Policy (NCFAP): http://www.ncfap.org/.
\4\ United States Geological Survey (USGS), national maps: http://ca.water.usgs.gov/pnsp/.
Note: Based on use amounts, EPA is proposing to monitor for the ESA and OA degradates of the three highest-use parent compounds: acetochlor, alachlor,
and metolachlor. In addition, EPA is proposing to monitor for acetochlor, alachlor, and metolachlor.
ii. Explosives--List 1.
Based on the rationale provided below, EPA is proposing that the
following three explosives compounds be part of the UCMR 2, List 1,
Assessment Monitoring:
Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX)
2,4,6-trinitrotoluene (TNT)
1,3-dinitrobenzene
RDX was a CCL 1 occurrence priority and was included on UCMR 1,
List 2 as ``reserved,'' because analytical methods were not available
in time for rule implementation. EPA has since developed a method for
determining explosives in drinking water, thus allowing RDX to be
included under UCMR 2 monitoring. RDX is absorbed by oral, dermal, and
inhalation routes, and has been documented to cause central nervous
system effects such as seizures, disorientation, nausea, restlessness,
and lethargy. In addition, temporary anemia and leukocytosis after
ingestion of RDX has been observed (ATSDR, 1995b). EPA has derived a
chronic oral RfD for RDX of 0.0003 mg/kg/day, based on prostate
inflammation observed in rats in a two-year feeding study (USEPA,
2003d), and has classified RDX as a possible human carcinogen (Group
C), based on adenomas and carcinomas in female mice (USEPA, 2003d).
The ``explosives'' method can also be used to measure
concentrations of at least 13 other contaminants in the same compound
class (see Exhibit 5). A few that can be detected by this method were
already monitored under UCMR 1 (nitrobenzene, 2,4-dinitrotoluene, and
2,6-dinitrotoluene). Of the remaining contaminants analyzed with the
explosives method, the two with the highest relative health risk
rankings are 2,4,6-trinitrotoluene (TNT) (possible carcinogen) and 1,3-
dinitrobenzene (high relative health risk ranking). TNT and 1,3-
dinitrobenzene were also identified during the CCL 1 development
process on the working group's initial list of chemical contaminants
considered during the development of the draft CCL (62 FR 52194 at
52201, October 6, 1997 (USEPA, 1997)).
TNT has been detected in surface and ground water samples that were
collected near munitions facilities (ATSDR, 1995c). TNT typically co-
occurs with RDX (Burrows, 1982). EPA has classified TNT as a possible
human carcinogen (Group C) based on urinary bladder papilloma and
carcinoma observed in female rats and activity observed in Salmonella,
with and without metabolic activation (USEPA, 2003d). Based on TNT's
co-occurrence with RDX and its possible carcinogenicity, EPA is
proposing to include TNT for monitoring under UCMR 2.
1,3-dinitrobenzene is the only one of the explosive contaminants
considered for UCMR 2 to have been assigned a ``high'' relative health
risk ranking. The major clinical manifestations of oral exposure to
1,3-dinitrobenzene are hematologic, neurologic, endocrine, and
reproductive (ATSDR, 1995a). EPA has derived a chronic oral RfD for
this compound of 0.0001 mg/kg/day, based on increased weight of the
spleen (USEPA, 2003d). EPA believes that a likely route of exposure to
this compound is ingestion of contaminated drinking water (ATSDR,
1995a). Though no nationwide survey of occurrence has been conducted,
local water and soil studies provide some indication of 1,3-
dinitrobenzene occurrence in water. This compound has been detected in
water and soil at some Army ammunition plants, including detection in
ground water samples collected at an ammunition plant in Louisiana at
concentrations ranging from 1.2 to 195 micrograms per liter ([mu]g/L)
(ATSDR, 1995a). It has also been found in 12 of the 1,397 hazardous
waste sites on the National Priorities List; however, the total number
of sites tested for 1,3-dinitrobenzene is unknown (ATSDR, 1995a). In a
survey of ground water at 32 military installations, Walsh and
colleagues (USEPA, 1999a) detected 1,3-dinitrobenzene in 13 percent of
the 812 samples analyzed, with maximum concentrations of 8.7 [mu]g/L
and a median concentration of 0.78 [mu]g/L. As the most toxic of the
remaining explosives, EPA believes that 1,3-dinitrobenzene should be
included for monitoring under UCMR 2.
Exhibit 5.--Analytes Included in the Explosives Method (EPA 529)
------------------------------------------------------------------------
Relative health
Status Analyte rank \1\
------------------------------------------------------------------------
To be monitored under UCMR 2, hexahydro-1,3,5- M(C)
List 1. trinitro-1,3,5- M(C)
triazine (RDX). H
2,4,6-trinitrotoluene
(TNT).
1,3-dinitrobenzene...
[[Page 49103]]
Not Listed on CCL 1 and Not 1,3,5-trinitrobenzene M
included on UCMR 2. 2,4,6- M
trinitrophenylmethyl L(S)
nitramine (Tetryl). L(S)
2-amino-4,6- na
dinitrotoluene. M(M)
2-nitrotoluene....... L(S)
3,5-dinitroaniline... L(S)
3-nitrotoluene.......
4-amino-2,6-
dinitrotoluene.
4-nitrotoluene.......
Listed on CCL 1 and Monitored 2,4-dinitrotoluene... M
under UCMR 1. 2,6-dinitrotoluene... M
nitrobenzene......... M
------------------------------------------------------------------------
\1\ Relative Health Effects Rankings include: H = high priority based on
potency data (RfD or equivalent); M = medium priority based on potency
data (RfD or equivalent); M(C) = medium priority based on potency data
(cancer unit risk); M(M) = medium priority based on toxicity data
(contaminants with Moderate (M) toxicity are contained in this
category); L(S) = low priority based on toxicity data (contaminants
with Slight (S) toxicity are contained in this category); (na) = not
available.
c. Selections from UCMR 1 Contaminants List. Perchlorate, the salts
of which have a number of industrial applications, is primarily used in
the form of ammonium perchlorate, an oxidizer in solid fuels that are
used to power rockets, missiles, and fireworks. In 1997, a method was
developed which greatly lowered the method reporting limit (MRL) for
perchlorate from approximately 400 [mu]g/L, down to 4 [mu]g/L.
Subsequent monitoring found perchlorate in ground water and drinking
water at and above this level. Perchlorate was listed on EPA's CCL 1
out of concern for its occurrence and possible health effects and was
monitored under UCMR 1 Assessment Monitoring using Method 314.0 (USEPA,
1999e), with a MRL of 4 [mu]g/L.
EPA has improved the measurement capabilities of the perchlorate
methods. Recently developed methods (EPA Method 314.1 (USEPA, 2004b);
EPA Method 331.0 (USEPA, 2004c); and EPA Method 332.0 (USEPA, 2004d))
would allow collection of occurrence data with a substantially lower
reporting level than that specified during UCMR 1. In addition, since
publication of Method 314.0, new instrumentation has been made
commercially available that can, using this method, achieve the MRL of
0.57 [mu]g/L while meeting all of the quality control criteria of the
method. Since Method 314.0 permits flexibility in the eluent,
chromatographic column, and suppressor that are used, this new
instrumentation is allowed within the scope of the method. In this
notice, EPA will refer to Method 314.0 using this new instrumentation,
which can achieve the lower MRL as ``Method 314.0 enhanced.'' EPA
estimates that the average cost per sample for the new methods will be
about $150, compared to $75 per sample using the original Method 314.0.
The National Academy of Sciences (NAS) has recently completed a
review of available perchlorate health effects research. Perchlorate
can affect thyroid function because it is an ion that competitively
inhibits the transport of iodide into the thyroid. EPA has adopted the
NAS recommended reference dose of 0.0007 mg/kg per day, which
translates into a drinking water concentration of 24.5 [mu]g/L,
assuming a 70 kg body weight and 2 liters per day consumption. This
assumes, however, that 100% of exposure comes from drinking water. An
important step for EPA in considering whether to regulate perchlorate
in drinking water is to determine what portion of perchlorate exposure
may come from food and other sources and what portion from drinking
water (referred to as relative source contribution or RSC). A higher
exposure from food would mean a lower exposure from drinking water that
would still be consistent with the NAS recommended reference dose.
EPA is considering whether to collect additional data on drinking
water occurrence for perchlorate and if so, what method(s) and MRL
should be required. The Agency already has substantial occurrence data
for perchlorate from UCMR 1 using the original Method 314.0, which
allowed for measurement of perchlorate at concentrations down to 4
[mu]g/L. However, to inform future decisions regarding perchlorate, EPA
sees advantages to gathering additional data on perchlorate using the
newer methods. This additional information would provide a more
complete understanding of perchlorate's occurrence in drinking water.
For large systems, the new monitoring data would supplement data
already collected by these systems under UCMR 1, while for small
systems, a different random sample would be monitored. Further,
additional data at lower reporting levels could inform EPA's cost
estimates for a potential regulation by identifying drinking water
systems that may want, as a practical matter, to target a somewhat
lower level than the MCL in their control strategies. Finally, EPA
believes the new methods are more reliable and respond to comments
about the potential for false positives in the original Method 314.0.
At the same time, EPA recognizes that there are costs associated with
this additional monitoring, most of which would be incurred by drinking
water utilities and their customers. The cost of an additional round of
monitoring using the original method 314.0, with an MRL of 4 [mu]g/L,
would have been about half of the cost associated with the new methods
and lower MRL. EPA estimates the total cost for a second round of
perchlorate monitoring using the new methods to be $4.4 million over
five years, of which about $4 million would be incurred by large
drinking water utilities (an average of $1,200 per utility serving
10,000 persons or more), and $434,000 would be paid by EPA to analyze
samples for small systems. EPA requests comment on its proposal to
include perchlorate on the UCMR 2 list and on the appropriate methods
and reporting level.
d. Selection of Emerging Contaminants. Ongoing research has
identified other emerging contaminants that EPA believes are important
to include on the UCMR 2 Contaminant List.
i. Nitrosamines--List 2.
EPA is proposing to include the following six nitrosamines on the
UCMR 2, List 2, Screening Survey:
N-nitroso-diethylamine (NDEA)
N-nitroso-dimethylamine (NDMA)
N-nitroso-di-n-butylamine (NDBA)
N-nitroso-di-n-propylamine (NDPA)
[[Page 49104]]
N-nitroso-methylethylamine (NMEA)
N-nitroso-pyrrolidine (NPYR)
These six compounds are all considered by EPA to be probable human
carcinogens, and have been assigned high relative health effects
rankings (USEPA, 2003d). Animal studies provide evidence that many
nitrosamines, including all of those being proposed for UCMR 2, target
the liver when ingested orally. Nitrosamines also produce carcinogenic
effects in the esophagus, lung, nasal cavity, stomach, and elsewhere
when administered to animal subjects in drinking water; and many
nitrosamines target the liver when ingested orally (USEPA, 2003d).
Nitrosamines are produced in small amounts for research purposes, and
can form as intermediates and byproducts in chemical synthesis and the
manufacture of rubber, leather, and plastics. Four of the six proposed
nitrosamines (all except N-nitroso-methylethylamine and N-nitroso-
pyrrolidine) are listed on the Toxics Release Inventory (TRI),\2\ which
requires reporting of releases to the environment and other waste
management data. Nitrosamines can also form spontaneously in the
environment by the reaction of precursor amines with nitrosating agents
(nitrate and related compounds), or by the action of nitrate-reducing
bacteria. Common foods such as bacon and malt beverages can contain
nitrosamines, and there is evidence that nitrosamines can form in the
upper gastrointestinal tract (ATSDR, 1989). One nitrosamine, N-nitroso-
dimethylamine (NDMA), has been shown to form in chlorinated or
chloraminated water as a disinfection byproduct (DBP) (Choi et al.,
2002; Choi and Valentine, 2002a and 2002b; Mitch and Sedlak, 2002).
---------------------------------------------------------------------------
\2\ The Toxics Release Inventory (TRI) is a publicly available
EPA database that contains information on toxic chemical releases
and other waste management activities reported annually by certain
covered industry groups as well as Federal facilities. This
inventory was established under the Emergency Planning and Community
Right-to-Know Act of 1986 and expanded by the Pollution Prevention
Act of 1990. Generally, reporting is required for facilities in
covered industries with more than 10 full-time employees that
annually manufacture or process more than 25,000 pounds, or use more
than 10,000 pounds of a toxic chemical. More information is
available at the TRI Program Web site at: http://www.epa.gov/tri.
---------------------------------------------------------------------------
No nationwide data are available on nitrosamine occurrence in
United States waters. However, other studies give an indication of
likely occurrence. Since 1998, a number of NDMA detections have been
reported in California ground water (CAEPA, 2002) and finished drinking
water (CADHS, 2002) above the State's action level of 0.01 [mu]g/L. The
American Water Works Association Research Foundation recently
collaborated with the Water Environment Research Foundation to fund a
study on NDMA occurrence and behavior in raw, treated, and recycled
water; however, the final report is not yet available.
Given evidence of the toxic nature of nitrosamines, and their
potential occurrence in the environment (particularly NDMA in drinking
water as a DBP), EPA proposes to include these six contaminants on the
UCMR 2 list to learn more about their occurrence in drinking water.
ii. Others Identified in CCL 1 Process and Recent Reviews of
Information on Emerging Contaminants--List 1.
The following additional contaminants are proposed for UCMR 2, List
1, Assessment Monitoring based on evaluation of CCL 1 lists and methods
research.
Dimethoate
Terbufos sulfone
Five flame retardants
Four polybrominated diphenyl ethers:
2,2',4,4'-tetrabromodiphenyl ether (BDE-47)
2,2',4,4',5-pentabromodiphenyl ether (BDE-99)
2,2',4,4',5,5'-hexabromodiphenyl ether (BDE-153)
2,2',4,4',6-pentabromodiphenyl ether (BDE-100)
One polybrominated biphenyl:
2,2',4,4',5,5'-hexabromobiphenyl (245-HBB)
There are a variety of reasons these contaminants are being
proposed for monitoring under UCMR 2. Terbufos sulfone was identified
through the CCL 1 development process as a deferred pesticide.
Dimethoate and the flame retardants are other contaminants that can be
measured by the same analytical method that is proposed for terbufos
sulfone. Terbufos sulfone and dimethoate have both been assigned
``high'' relative health effects rankings. Flame retardants are being
proposed by EPA for UCMR monitoring because of recent concern that
these have become widely occurring environmental contaminants (Darnerud
et al., 2001).
Although little is known regarding the health effects of terbufos
sulfone, EPA has established an RfD of 0.00005 mg/kg/day for the parent
compound, terbufos, based on a no observable adverse effect level for
plasma cholinesterase inhibition (USEPA, 1999b). Terbufos was monitored
under UCMR 1. Similar to the acetanilide degradates, however, EPA is
concerned that terbufos sulfone will be found more commonly in the
environment than its parent compound, based on the rapid decomposition
of the parent compound. Such rapid decomposition combined with concern
regarding the health effects of the parent compound terbufos justify
determining the occurrence of terbufos sulfone in drinking water.
The method EPA proposes for the analysis of terbufos sulfone can
measure many other contaminants (over 40). However, EPA used relative
health effects information to identify the highest priorities and to
comply with the statutory limit of 30 contaminants per UCMR monitoring
cycle. Of the remaining compounds that could be measured using gas
chromatography/mass spectrometry (GC/MS), the technology used in Method
527, dimethoate is being proposed for UCMR 2 monitoring because it
received a ``high'' ranking in EPA's health effects screening (USEPA,
2004h). Dimethoate is a TRI chemical that is produced for use on cotton
and other field crops, orchard crops, vegetable crops, in forestry, and
residential uses (USEPA, 1999f).
Dimethoate is rapidly absorbed, metabolized, and eliminated in rats
by oral or intravenous routes of administration (USEPA, 1999d). This
compound is a cholinesterase inhibitor and exerts its major toxic
effects through overstimulation of the nervous system (USEPA, 2003a).
Health effects include headache, weakness, coma, and death from
respiratory failure (HSDB, 1986). Dimethoate has been classified as a
``possible human carcinogen'' and EPA has established an RfD for this
compound of 0.0002 mg/kg/day (USEPA, 2003d). No national data is
available on the occurrence of dimethoate in waters of the United
States; however, two local studies provide an indication of limited
occurrence (USEPA, 1999f).
Synthetic flame retardants are among the other contaminants that
are measured by EPA Method 527. Flame retardants, such as
polybrominated diphenyl ethers (PBDEs) and polybrominated biphenyls
(PBBs), are added to plastics used in a variety of consumer products
such as computer monitors, televisions, textiles, and plastic foams.
Production of PBBs ended in 1976 in the United States following an
incident of significant agricultural contamination in 1973, but PBDEs
are still produced and used in the United States. Flame retardants have
been measured at low levels in air, sediments, animals, and food and
are believed to be widely occurring in the environment (Darnerud et
al., 2001). Recent data also indicate that total levels of flame
retardants are rapidly
[[Page 49105]]
increasing and that most people are exposed to low levels of these
contaminants (Hites, 2004). Findings from animal studies suggest
thyroid and liver effects, as well as possible reduced immune system
function and neurobehavioral alteration (ATSDR, 2002).
3. Other Considerations in Selecting Contaminants
EPA has identified nine analytical methods and 26 priority
contaminants for UCMR 2 monitoring. EPA considered many more
contaminants and methods for UCMR 2. Some of these contaminants were
given strong consideration but were not included as part of the
proposed UCMR 2, as discussed in the following section.
a. Triazine Chlorodegradates and Parent Compounds. While they are
not part of today's proposal, EPA invites comments on the possibility
of UCMR 2 monitoring for three triazine chlorodegradates and three of
their parent compounds, as follows:
Desethylatrazine (DEA)
Desisopropylatrazine (DIA)
Diaminochlorotriazine (DACT) \3\
Atrazine
Simazine
Propazine
---------------------------------------------------------------------------
\3\ Another commonly used name for DACT is
desthyldesisopropylatrazine.
---------------------------------------------------------------------------
EPA is interested in these chlorodegradates and three parent
compounds because the Agency is conducting a cumulative risk assessment
for the chlorodegradates as a group with atrazine, simazine and
propazine. The ``triazines and degradation products of triazines'' are
also CCL 1 contaminants.
Atrazine and simazine are regulated contaminants with MCLs of 3
[mu]g/L and 4 [mu]g/L, respectively. Propazine was a cancelled
pesticide based on its contamination of ground water but was
reintroduced for greenhouse uses only (it is now used on container
grown ornamentals in greenhouses); however, EPA is currently evaluating
a proposal to use propazine for the control of broadleaf weeds and
annual grasses in sorghum, a use previously listed on labels, but
voluntarily removed prior to 1990. Propazine was identified through the
CCL 1 development process as a deferred pesticide. A fourth triazine,
cyanazine, is not being addressed since its production and use were
phased out between 1996 and 2002.
Atrazine, simazine and propazine metabolize into various
chlorodegradation products of which Desethylatrazine (DEA),
Desisopropylatrazine (DIA), and Diaminochlorotriazine (DACT) are the
most significant. Atrazine forms all three of these chlorodegradates;
whereas, simazine, a diethyl analogue of atrazine, degrades to DIA and
DACT, and propazine, a diisopropyl analogue of atrazine, degrades to
DACT and DEA (Scribner et al., 2000). In addition, ambient water
monitoring data indicate that concentrations of these chlorodegradates
in water may be equal to, or even exceed, concentrations of atrazine
(and other parent compounds) (Scribner et al., 2000). While atrazine
and simazine are already regulated under the National Primary Drinking
Water Standards, EPA is 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 degradation products.
EPA is currently developing a liquid chromatography/tandem mass
spectrometry (LC/MS/MS) method to analyze the parent triazines and
these chlorodegradates and expects that method to be available within
the next year. Depending on method development progress, EPA's further
assessment of the relative health effects of triazine degradates, and
comments received pursuant to today's proposed regulation, EPA may
consider adding triazines and degradates to the Screening Survey for
UCMR 2. Because only 30 analytes can be monitored during any one cycle
of the UCMR program, EPA recognizes that the addition of the triazines
and degradates to the Screening Survey may require the elimination of
other contaminants from UCMR 2. Contaminants that EPA is considering in
this regard may include one or more of the acetanilide pesticides or
degradation products (see section III.A.2.b.i), which are also measured
using an LC/MS/MS method. EPA invites comments on whether the
concurrent use of two similar methods may strain laboratory capacity.
b. Other Contaminants Considered. EPA had originally identified
over 200 contaminants as potential UCMR 2 priorities. Many were
eliminated based on specific criteria, as discussed in section III.A.2
of this action (including the requirements that pesticides must be
registered, reference standards must be available, and the analytical
method must be available to include in this proposed action). Those
eliminated or deferred due to other considerations are worthy of
further mention because of particular public interest. These
contaminants, and the reasons for their exclusion from today's proposed
action, include:
Aeromonas: The UCMR 1 Screening Survey for Aeromonas
indicates that it warrants further evaluation. Data analyzed thus far
have identified Aeromonas at the genus level. Identification and
analysis of pathogenic strains for some of the small system samples is
underway but have not been completed as of the publication of this
proposed action. EPA believes that it is premature to propose
additional monitoring for Aeromonas. The evaluation of the speciation
of the isolates collected during UCMR 1, and the development of a more
routine and affordable species-specific method will support future
monitoring, if deemed appropriate.
Cyanotoxins: While extensive analytical methods
development was conducted for one class of cyanobacteria toxins,
microcystins, in preparation for UCMR 2, adequate accuracy in surface
waters with total organic carbon levels of 2 mg/L and higher has not
yet been demonstrated. Two other cyanotoxins--anatoxin A, and
cylindrospermopsin--were included in the initial method development.
However, these were not compatible with the microcystin method being
developed, and other analytical methods will not be available in time
for UCMR 2 monitoring. Therefore, none of the cyanobacteria toxins are
being proposed for monitoring at this time. However, further analytical
methods development is continuing.
Diuron: EPA considered whether Diuron would be a good
candidate to include in UCMR 2 Assessment Monitoring. Interim
monitoring results from the UCMR 1 Screening Survey have shown only one
detection of Diuron. Because this suggests very low occurrence in
drinking water, and because other contaminants are of greater relative
health effects concern, Diuron was not established as a priority
contaminant for UCMR 2 monitoring.
Ethylene thiourea: While extensive analytical methods
development was conducted for ethylene thiourea in preparation for UCMR
2, reproducible recoveries have not yet been demonstrated. Therefore,
ethylene thiourea is not being proposed for monitoring at this time.
However, further analytical methods development is continuing.
Mirex and TBBPA: Mirex was considered for UCMR 2
monitoring and was found to have a ``high'' relative health effects
ranking. Though it can be measured using the GC/MS method, Mirex has
not been used or produced in the United States since 1978. For this
[[Page 49106]]
reason, EPA has not included Mirex on the list of UCMR 2 priorities. In
addition, tetrabromobisphenol A (TBBPA), a brominated flame retardant,
was initially considered for inclusion on the list of contaminants to
be measured using GC/MS, EPA Method 527. However, TBBPA was found to be
incompatible with this method, and is therefore not included on the
list of UCMR 2 priorities.
B. What Analytical Methods Will Be Used for Monitoring?
The analytical methods that are being proposed for use in UCMR 2
and the contaminants that they measure are listed in Exhibit 6. EPA has
conducted both literature searches, as well as searches of available
consensus method organizations' publications for additional analytical
methods that could be used to support this monitoring. No such
additional methods were identified that meet the requirements of this
proposed action. All of the analytical methods proposed use either mass
spectrometry or tandem mass spectrometry (i.e., MS/MS) for the
detection of the analytes, with the exception of EPA Methods 314.0
enhanced and 314.1 (USEPA, 1999e and USEPA, 2004b, respectively).
EPA is proposing that all positive occurrences of perchlorate
(i.e., those at or above the MRL of 0.57 [mu]g/L), determined using the
Methods 314.0 enhanced or 314.1, must be confirmed through the use of a
second chromatographic column, as detailed in Method 314.1, or by MS or
MS/MS, using EPA Methods 331.0 or 332.0 (USEPA, 2004c and USEPA, 2004d,
respectively). EPA requests comment on the level at which positive
occurrences of perchlorate must be confirmed.
By design of the UCMR program, UCMR contaminants measured by
analytical techniques that are commonly available are assigned to List
1, Assessment Monitoring (EPA Methods 314.0 enhanced, 314.1, 331.0,
332.0, 527, and 529). While most of these are newly developed
analytical methods, the techniques they employ are in common use by
drinking water laboratories. These methods are assigned to Assessment
Monitoring because this is the largest component of UCMR, with
monitoring conducted by a sample of 800 systems serving 10,000 or fewer
people, and all systems serving more than 10,000 people (approximately
3,200 systems).
UCMR contaminants that are measured by analytical methods that have
been recently developed and use techniques that are not commonly used
in drinking water analyses are assigned to the List 2, Screening
Survey. These less common methods are generally more appropriate for
the Screening Survey because fewer laboratories will be capable of
conducting such analyses, and the smaller scale monitoring under the
Screening Survey should reduce potential laboratory capacity issues.
However, in order to monitor for the parent compounds of the
acetanilide degradates, Method 525.2, which is commonly used for
regulated monitoring, is also being included for List 2 monitoring.
During the Screening Survey, a sample of 800 systems serving 100,000 or
fewer people and all (approximately 320) systems serving more than
100,000 people would monitor. Exhibit 6, summarizes the UCMR 2 methods
and associated contaminants.
Exhibit 6.--Analytical Methods Proposed for UCMR 2 Monitoring
------------------------------------------------------------------------
Analytical method \1\ Contaminant UCMR 2 List
------------------------------------------------------------------------
EPA Method 314.0 enhanced Perchlorate......... List 1, Assessment
(IC/Conductivity). Monitoring: 1
contaminant.
EPA Method 314.1 (IC/
Conductivity)
EPA Method 331.0 (LC/MS or
LC/MS/MS)
EPA Method 332.0 (IC/MS or
IC/MS/MS)
EPA Method 527 (SPE/GC/MS).. 2,2',4,4'-
tetrabromodiphenyl
ether (BDE-47).
2,2',4,4',5-
pentabromodiphenyl
ether (BDE-99).
2,2',4,4',5,5'-
hexabromobiphenyl
(245-HBB).
.................... List 1, Assessment
Monitoring: 7
contaminants.
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
2,4,6- Monitoring: 3
trinitrotoluene contaminants.
(TNT).
Hexahydro-1,3,5-
trinitro-1,3,5-
triazine (RDX).
EPA Method 521 (SPE/GC/CI/MS/ N-nitroso- List 2, Screening
MS). diethylamine (NDEA). Survey: 6
N-nitroso- contaminants.
dimethylamine
(NDMA).
N-nitroso-di-n-
butylamine (NDBA).
N-nitroso-di-n-
propylamine (NDPA).
N-nitroso-
methylethylamine
(NMEA).
N-nitroso-
pyrrolidine (NPYR).
EPA Method 535 (SPE/HPLC/MS/ Acetochlor ESA...... List 2, Screening
MS). Acetochlor OA....... Survey: 6
Alachlor ESA........ contaminants.
Alachlor OA.........
Metolachlor ESA.....
Metolachlor OA......
EPA Method 525.2 (SPE/GC/MS) Acetochlor.......... List 2, Screening
Alachlor............ Survey: 3
Metolachlor......... contaminants.
[[Page 49107]]
Total of 26 UCMR 2
contaminants
------------------------------------------------------------------------
\1\ EPA Method 314.0: Determination of Perchlorate in Drinking Water
Using Ion Chromatography (USEPA, 1999e). Note: Since Method 314.0 was
published in 1999 to support UCMR 1 monitoring at an MRL of 4.0 [mu]g/
L, new instrumentation has been made commercially available from
Metrohm Peak that can, using this method, achieve the MRL of 0.57
[mu]g/L as called for by this proposed regulation, while meeting all
of the quality control criteria of the method. Because enhanced Method
314.0 permits flexibility in the eluent, chromatographic column, and
suppressor that are used, this new instrumentation would be permitted
within the scope of the original method. Therefore, enhanced Method
314.0 is being proposed for use in this regulation.
EPA Method 314.1: Determination of Perchlorate in Drinking Water Using
Inline Column Concentration/Matrix Elimination Ion Chromatography with
Suppressed Conductivity Detection (USEPA, 2004b).
EPA Method 331.0: Determination of Perchlorate in Drinking Water by
Liquid Chromatography Electrospray Ionization Mass Spectrometry
(USEPA, 2004c)
EPA Method 332.0: Determination of Perchlorate in Drinking Water Using
Ion Chromatography with Suppressed Conductivity and Electrospray
Ionization Mass Spectrometry (USEPA, 2004d).
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, 2004e).
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, 2004f).
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, 2003c).
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, 2004g).
C. How Were These Analytical Methods Developed?
EPA developed the proposed analytical methods at two laboratories
in Cincinnati, Ohio: The Office of Water, Office of Ground Water and
Drinking Water's Technical Support Center and the Office of Research
and Development, National Exposure Research Laboratory's Chemical
Exposure Research Branch. Additional methods development support was
provided by: The Dionex Corporation, Sunnyvale, California; Metrohm
Peak, Houston, Texas; Office of Research and Development's Ground Water
and Ecosystems Restoration Division, Ada, Oklahoma; and EPA's Region 1,
New England Laboratory, Chelmsford, Massachusetts.
Extensive method testing was performed for each of the analytical
methods developed for this proposed action. Each step of each method
was tested for robustness and to evaluate the amount of user
flexibility that could be permitted for that step. Additional details
concerning this testing, beyond that included in each method, are
contained in methods research reports. These reports are available for
each newly developed method being proposed in the docket for this
action. However, no such report is available for Method 314.0, which
was developed for UCMR 1, or for Method 525.2, which was developed in
1995. Wherever feasible, EPA permitted the maximum user flexibility
commensurate with maintaining data quality. In addition, each method
was tested in a second or, for some methods, a third laboratory. These
second and third laboratory studies were designed to test the precision
and accuracy of each method in reagent water and in different drinking
water matrices, as well as the ease of use of the method and the
clarity of the written instructions of the method. Reports containing
the data developed during these second and third laboratory studies are
also available in reports included in the docket for this action for
each newly developed method being proposed. Similar data was generated
in to support the proposed action of Method 314.0. These data are also
included in the docket for review.
The methods developed for UCMR 2 analyses were peer reviewed in
accordance with the Agency's peer review guidelines detailed in the
``Science Policy Council Handbook, Peer Review'' (USEPA, 2000b).
Methods 314.0 and 525.2, which were developed prior to 2000, were peer
reviewed using similar criteria.
D. How Were Minimum Reporting Levels Determined?
Minimum Reporting Levels (MRLs) represent an estimate of the lowest
concentration of a compound that can be quantitatively measured by a
group of experienced drinking water laboratories. EPA is proposing that
all laboratories providing UCMR 2 analysis be required to demonstrate
their ability to measure each compound at the MRL proposed for that
compound in Sec. 141.40(a)(3) of today's action. EPA has developed a
protocol for developing MRLs based on Lowest Concentration MRLs
(LCMRLs) that were determined by each laboratory that developed or
subsequently tested the methods listed in today's action. LCMRLs
represent the lowest concentration of a compound that can be
quantitatively determined in each individual laboratory. EPA invites
comments on the LCMRL/MRL approach and notes that in a related action,
EPA's Office of Water is about to begin an evaluation of a wide range
of detection and quantitation approaches under the Federal Advisory
Committee Act (FACA) process. EPA expects to consider the comments and
feedback from this FACA process to the extent possible in the
development of the UCMR 2 final rule.
MRLs have previously been determined by analytical laboratories
using expert professional judgement, but standard criteria for MRL
determination have not been established. In both the Information
Collection Rule (61 FR 24354, May 14, 1996 (USEPA, 1996b)) and 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 has developed a statistical protocol for single-
laboratory determinations of LCMRLs using linear regression and
prediction intervals. This approach, described in detail in the report
titled ``Statistical Protocol for the Determination of the Single-
Laboratory Lowest Concentration Minimum Reporting Level (LCMRL) and
Validation of the Minimum Reporting Level (MRL)'' (USEPA, 2004j), has
been evaluated through expert peer review conducted in accordance with
the Agency's formal peer review process and through the performance of
a pilot-scale interlaboratory study. The
[[Page 49108]]
proposed protocol is available to the public, and can be found at:
http://www.epa.gov/safewater/methods/sourcalt.html.
Details of this pilot-scale interlaboratory study are contained in
a report titled ``Evaluation of the Lowest Concentration Minimum
Reporting Level (LCMRL) and the Minimum Reporting Level (MRL) Primary
Analyte Analysis'' (USEPA, 2004i). An evaluation of the procedures used
in this proposed action, and other tested procedures to determine MRLs
from LCMRLs, are detailed in Chapter 4 of the report. The guidelines
and procedures for using LCMRLs in establishing MRLs for UCMR 2 are
described later in this section.
As proposed, the MRL would be the lowest analyte concentration that
meets Data Quality Objectives (DQOs) as presented in Sec. 141.40(a)(5)
of today's proposed rule, and represents the lowest concentration for
which future recovery is predicted to fall, with high confidence (99
percent), between 50 percent and 150 percent. MRLs would be applicable
to all laboratories that perform the analysis of drinking water samples
as part of UCMR 2. All UCMR 2 laboratories would be required to
validate their performance at or below the MRLs before initiating any
analyses. This proposal does not require that measurements observed at
concentrations below the MRL be reported. In other programs, such
reporting may be appropriate. The appropriateness of reporting
measurements below the MRL, is generally dependent upon the objectives
of a study and is not addressed in this proposed action.
To determine the MRLs listed in today's action, each laboratory
that conducted the primary analytical method development, or second or
third laboratory studies, determined LCMRLs as detailed in the
statistical protocol (USEPA, 2004g). The mean of these LCMRL values was
calculated for each analyte. In cases where data from three or more
laboratories were available, three times the standard deviation of the
LCMRLs was added to the mean of the LCMRLs, to establish the MRL. In
cases where data from two laboratories were available, three times the
difference of the LCMRLs was added to the mean of the LCMRLs. In
statistical theory (Chebyshev's Inequality), three standard deviations
around the mean incorporates the vast majority (at least 88.9 percent)
of the data points. In the case where there are only two laboratories,
the difference serves as a surrogate for the standard deviation due to
the uncertainty in the estimate of the standard deviation with only two
data points. The MRL for each analyte was determined by then rounding
this number to two significant digits.
Note that Method 525.2 was published before the LCMRL protocol was
developed. Therefore, no LCMRL data are available for the analytes
being determined using this method. The MRLs for acetochlor, alachlor,
and metolachlor were determined using the same procedure used in UCMR
1, i.e., multiplication of the highest individual laboratory method
detection limit in the method by a factor of 10. Note also that there
is a single MRL for perchlorate, although there are four methods
approved for UCMR analyses. The value of 0.57 [mu]g/L is a mid-range
value (and the MRL determined for Method 332.0) that is easily
achievable for Methods 314.1, 331.0, and 332.0; and slightly more
difficult to achieve using Method 314.0.
LCMRLs were calculated by selected laboratories during analytical
method development. There is no requirement for laboratories that are
analyzing samples under the UCMR to determine LCMRLs. The procedure for
LCMRL determination includes the following:
Calibration curve analysis;
Replicate sample analysis requirements;
Linear regression procedures; and
Outlier evaluation.
The validation of laboratory performance at or below the MRL would
be required to be performed by all laboratories that analyze samples
under UCMR 2. Validation would consist of two procedures:
As part of the Initial Demonstration of Capability (IDC)
for each analytical method, each laboratory would need to process seven
replicate samples, spiked at or below the MRL, through the entire
method procedure (i.e., including extraction and with all
preservatives, where applicable). This step would need to be performed
for each analyte. Laboratories would be required to demonstrate that,
based on the results of the seven replicates, their predicted range of
results will fall, with 99 percent confidence, within 50 percent to 150
percent recovery, inclusive.
During sample analysis, laboratories would need to run a
daily check sample to demonstrate that, at or below the MRL for each
analyte, the measured recovery is within 50 percent to 150 percent,
inclusive. The results for any analyte for which 50 percent to 150
percent recovery cannot be demonstrated during the daily check would
not be valid. Laboratories may elect to re-run the daily performance
check sample if the performance for any analyte or analytes cannot be
validated. If the performance for these analytes is validated, then the
laboratory performance would be considered validated. If not, or as an
alternative to analysis of a second check sample, the laboratory may
re-calibrate and repeat the performance validation process for all
analytes.
Further details regarding these procedures are available through
EPA's UCMR Web site (http://www.epa.gov/safewater/ucmr/ucmr2/index.html) in a document titled ``UCMR 2 Laboratory Approval
Requirements and Information Document'' (USEPA, 2004k).
E. How Will Laboratories Conduct UCMR Analyses?
All laboratories conducting analyses under this regulation must be
approved by EPA to perform those analyses. Laboratories seeking
approval must provide EPA with data that demonstrates their successful
completion of an IDC as outlined in each method, verification of
successful performance at the MRLs as specified in today's action, and
successful participation in an EPA Proficiency Testing (PT) program for
the analytes of interest. On-site audits of selected candidate
laboratories may be conducted. Details of the EPA laboratory approval
program are contained in the technical manual titled: ``UCMR 2
Laboratory Approval Requirements and Information Document'' (USEPA,
2004k). This document will be available on the electronic docket at:
http://www.epa.gov/edocket/; or through EPA's UCMR Web site: http://www.epa.gov/safewater/ucmr/ucmr2/index.html. In addition, EPA may
supply analytical reference standards for selected analytes to
participating/approved laboratories.
1. Laboratory Approval Process for UCMR 2
The UCMR 2 laboratory approval program is designed to assess and
confirm the capability of laboratories to perform analyses using the
methods listed in Table 1 of today's proposed rule, in Sec.
141.40(a)(3). With the exception of EPA Method 525.2, the UCMR 2
methods do not currently have an established certification program.
Applicant laboratories that are already approved by their State or
primacy entity to conduct drinking water analyses using Method 525.2
will still need to perform the UCMR approval steps, including the
related PT evaluation. The UCMR 2 laboratory approval process is
designed to assess whether laboratories meet the required equipment,
laboratory performance, and
[[Page 49109]]
data reporting criteria described in today's action. This evaluation
program is voluntary in that it only applies to laboratories intending
to analyze UCMR 2 drinking water samples. However, EPA will require
systems to use UCMR 2-approved laboratories when conducting monitoring
for those analytes listed in Table 1 of Sec. 141.40(a)(3) of this
rule. A list of laboratories approved for UCMR 2 will be posted to
EPA's UCMR Web site: http://www.epa.gov/safewater/ucmr/ucmr2/labs.html.
Laboratories are encouraged to apply for UCMR 2 approvals as early as
possible, as schedules for large PWS sampling will be completed soon
after the final rule is promulgated. 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: [email protected]. EPA will begin accepting requests for
registration forms for the methods associated with the UCMR Contaminant
List (including List 1, Assessment Monitoring, and List 2, Screening
Survey) beginning August 22, 2005. The laboratory must request the
necessary registration forms within 90 days after final rule
publication.
b. Registration. EPA will send each laboratory that requests
registration forms to conduct UCMR 2 analysis 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: 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 that 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
information. 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. EPA intends to offer up to four opportunities for a
laboratory to successfully analyze the UCMR 2 PT samples. Up to three
of these studies will be conducted prior to the publication of the
final rule, but at least one study will be conducted after publication
of the final rule. When a laboratory passes a PT for one of the UCMR 2
methods, EPA will not send a PT sample for that method in later PT
opportunities. 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. No laboratories will be approved that did not successfully
complete a PT study.
f. Written EPA Approval. After the first five steps (a. through e.)
have been successfully completed, EPA will send the laboratory a letter
listing the methods for which approval is pending (if the PT study and
laboratory evaluation is conducted prior to promulgation of the final
rule) or approval is granted (after promulgation of the final rule).
Laboratories receiving a pending approval may be automatically approved
following promulgation of the final rule, or they may need to repeat
all or part of the approval process, contingent upon what changes are
applied to the rule between proposal of the draft rule and promulgation
of the final rule. These letters will also include a reminder that the
laboratory may be subject to on-site audits.
2. Quality Control Requirements
For UCMR 2, EPA has made several changes to the quality control
requirements, which were previously located in Sec. 141.40, Appendix
A. The quality control steps in Appendix A information will be moved to
Sec. 141.40(a)(5). Requirements related to MRLs and to laboratory
approvals will be incorporated into this section of the proposed rule,
and are discussed in sections III.D and III.E.1, respectively. Changes
related to the quality control requirements include:
The language regarding Detection Limits will be replaced
with the requirement to validate each laboratory's performance at or
below the MRL. Since UCMR 1 was promulgated, EPA has developed new MRL
and LCMRL procedures. The MRL procedures are now described in Sec.
141.40(a)(5). Guidelines and procedures for using LCMRLs in
establishing MRLs for UCMR 2 are described in this preamble, and in a
document entitled: ``Statistical Protocol for the Determination of the
Single-Laboratory Lowest Concentration Minimum Reporting Level (LCMRL)
and Validation of the Minimum Reporting Level (MRL)'' (USEPA, 2004j).
The calibration step will be changed to remove the
requirement for acceptance ranges for each analytical method. Because
all of the methods approved for UCMR 2 monitoring specify calibration
acceptance criteria, it is not necessary to specify criteria in this
rule.
The requirement to analyze a field reagent blank (Reagent
Blank Analysis) will be removed because the analysis of a field reagent
blank is not required in any of the methods proposed for UCMR 2. None
of the analytes being proposed are sufficiently hydrophobic or volatile
enough for there to be a serious concern about sample contamination
during shipping.
The requirement to analyze Quality Control Samples will be
removed since they are not available for the majority of the analytes
contained in this rule.
The terms Matrix Spike and Matrix Spike Duplicate will be
replaced with Laboratory Fortified Sample Matrix and Laboratory
Fortified Sample Matrix Duplicate, respectively, to be consistent with
the terms specified in the data
[[Page 49110]]
elements table in Sec. 141.35(e) of today's proposed action.
The language to describe Internal Standard Calibration
will be modified to more clearly describe the requirements.
The requirements regarding the Method Performance Test
will not be changed.
The requirements related to Detection Confirmation will be
revised to be consistent with the methods being approved in this rule.
Analytical results for perchlorate determined to be at or above the MRL
using Methods 314.0 and 314.1 are required to be confirmed by a second
chromatographic column, or by confirmation using Method 331.0 or 332.0,
before being reported. Alternatively, the primary analysis of
perchlorate may be conducted using either Method 331.0 or 332.0.
Reporting requirements will be clarified and modified such
that laboratories will be required to report their data to EPA's
electronic data reporting system (http://www.epa.gov/safewater/ucmr/ucmr2/reporting.html) within 120 days of sample collection. PWSs have
60 days from the laboratory posting to review, approve, and submit the
data to the State and EPA via the electronic reporting system. After 60
days from the laboratory's posting, if the PWS has not approved and
submitted the data, the data will be considered approved and final for
EPA review.
No changes will be made to the requirements related to Sample
Collection and Preservation other than the addition of the requirement
for laboratories using Method 314.0 for the analysis of perchlorate to
preserve their samples as required in the other approved perchlorate
analysis methods. In addition, the requirements concerning Method
Defined Quality Control will not be changed.
F. How Are Systems Selected for UCMR Monitoring?
1. How Are Systems Selected for Assessment Monitoring?
a. Original Assessment Monitoring Statistical Approach for UCMR 1.
Under UCMR 1, Assessment Monitoring was specified to be conducted by
all large CWSs and NTNCWSs serving more than 10,000 people (e.g., a
census of large systems, totaling approximately 3,100), and by a
statistically representative sample of 800 small systems (systems
serving 10,000 or fewer people). The large size of the stratified
random sample allowed for a high level of confidence in the resulting
monitoring data and low error or uncertainty within the sample. The
List 1 contaminants monitored under Assessment Monitoring are the
priority contaminants for which analytical methods have already been
developed.
EPA identified DQOs for the representative sample of small systems
to include the following: data must provide unbiased national exposure
estimates; and margins of error must be kept to 1 percent
with 99 percent confidence for CWSs and 2.5 percent with 95
percent confidence for NTNCWSs. Use of a standard statistical design
formula to estimate the minimum sample size and an assumed estimated
occurrence of approximately 1 percent resulted in a minimum sample size
of 659 systems. The sample size was then adjusted upwards to account
for additional DQOs. Furthermore, the sample was stratified across
system size, water source, and type to account for differences in
vulnerability, differential occurrence, and management capacity, as
outlined below.
The small system representative sample was designed to account for
different system sizes, types of systems, sources of water supply,
contaminants likely to be found, and geographic location (e.g.,
States), as outlined in SDWA section 1445(a)(2)(A). The sample was
stratified considering the proportion of the population served by CWSs
and NTNCWSs by water source type (i.e., ground or surface water) and
system size category (i.e., serves 25 to 500 people, 501 to 3,300
people, and 3,301 to 10,000 people) within the water source type. This
stratification allowed EPA to account for different exposure risks of
contaminant occurrence that may be related to the differential
vulnerability of water sources and differing management and financial
capacity that can vary across system types and sizes.
EPA also allocated the selection of small systems across all the
States and territories to account for differences in spatial
vulnerability and contaminant occurrence and made adjustments to ensure
equity in participation. Because contaminant exposure assessment was a
primary goal of UCMR 1, EPA began with a base design that allocated
systems to States in proportion to the population served. This
population-weighted allocation leads to the best estimates of national
exposure. However, this approach, when strictly applied, assigns small
numbers of systems, or even zero systems, to the smallest States and
territories. To ensure the sample was fully representative of the
nation and to provide equity across States for involvement in the UCMR,
EPA adjusted the population-based design to include at least two
systems from each State and territory in the United States (with the
exception of Guam, which had only one PWS that qualified). Small Tribal
water systems in each of the 10 EPA Regions were grouped into a single
category for the representative sample. Thus, the Tribal category was
equivalent to a ``State'' for the statistical selection process, which
ensured that Tribal systems would be selected. Exhibit 7 summarizes the
system allocation across system sizes and water sources, including the
adjustment for a minimum of two systems per State.
Exhibit 7.--Approximate Sample Allocation for Assessment Monitoring: Expected Number of Systems Selected by
System Size and Water Source \1\
----------------------------------------------------------------------------------------------------------------
Surface water
Size category Ground water (and GWUDI) Total
systems systems \2\
----------------------------------------------------------------------------------------------------------------
500 and Under................................................... 103 57 160
501 to 3,300.................................................... 250 50 300
3,301 to 10,000................................................. 230 110 340
-----------------
Total................................................... 583 217 800
----------------------------------------------------------------------------------------------------------------
\1\ For more information see ``Statistical Design and Sample Selection for UCMR 1'' (USEPA, 2001c).
\2\ GWUDI = ground water under the influence of surface water.
[[Page 49111]]
To provide an improved understanding of contaminants and conditions
affecting small systems in UCMR 1, EPA selected 30 small PWSs from the
systems in State Monitoring Plans as ``Index Systems'' at which
contaminants would be monitored every year during the five-year cycle.
EPA conducted the sampling and testing for the Index Systems. At the
time of sampling, EPA also gathered other data to characterize the
environmental setting affecting the system including precipitation,
land and water resource use, and environmental data (such as soil type
and geology).
The details of the design are included in ``Statistical Design and
Sample Selection for the UCMR 1'' (USEPA, 2001c). The design of UCMR 1
was subjected to peer review and improved by recommendations of the
peer reviewers, as well as from suggestions made during the public
comment and response process in developing UCMR 1.
b. Proposed Assessment Monitoring Statistical Approach for UCMR 2.
EPA proposes to maintain the same basic statistical design for its UCMR
2 national representative sample of 800 small systems and to continue
with a census of large water systems for Assessment Monitoring. EPA
believes that the combination of a nationally representative sample of
small systems and a census of large systems provides a powerful tool
for assessing contaminant occurrence in PWSs, and believes that this is
the most effective and accurate survey approach, as long as methods,
laboratory capacity, and cost issues allow for its implementation.
EPA is proposing to eliminate Index System monitoring at small
systems under UCMR 2 based on the lack of contaminant occurrence
observed at Index Systems monitored in UCMR 1.
2. How Are Systems Selected for the Screening Survey?
a. Original Screening Survey Statistical Approach for UCMR 1. The
Screening Survey tier of UCMR 1 was designed as a statistical sample to
assess contaminant occurrence in PWSs. However, because of the small
number of systems, the resulting data were only designed to be used for
national estimates. Individual strata had too large a variance to
provide meaningful estimates. The Screening Survey, List 2 contaminants
were those for which uncommon analytical methods were used. To ensure
there was enough laboratory capacity to conduct these new, specialized
analyses, the Screening Survey sample size was limited to 300 systems
(120 large and 180 small PWSs). Screening Survey results from UCMR 1
were generally expected to provide only enough information for EPA to
determine whether a contaminant should be elevated to future Assessment
Monitoring because at low occurrence there would be considerable
uncertainty. Only at a relatively high level of occurrence could a
contaminant be moved directly to regulatory determination using the
UCMR 1 Screening Survey data.
The Screening Survey sample of systems was randomly selected from
the Assessment Monitoring sample pool to allow systems some efficiency
in conducting sampling for both tiers of monitoring. Screening Surveys
and Assessment Monitoring were scheduled to coincide for those small
system systems selected for both. By design, large Screening Survey
systems were selected from the pool of all large systems, as all were
required to conduct Assessment Monitoring. However, there were
difficulties with the sample selection for small systems because the
sample pool was small. During either of the two UCMR 1 Screening Survey
years, the sample pool was restricted to one-third of the Assessment
Monitoring systems (approximately 267). Thus, the Screening Survey
sample of 180 small systems represented approximately 67 percent of the
available sample pool in a given year.
In general, the smaller sample size of the Screening Surveys is
associated with higher margins of error and lower confidence in
estimating contaminant occurrence (compared to the larger Assessment
Monitoring sample). Although the sample as a whole can provide
nationally representative estimates, sample results cannot be
subdivided to be representative of individual strata, as they can be
with the larger Assessment Monitoring sample. In addition, uncertainty
is high for low occurrence contaminants. The samples for each Screening
Survey under UCMR 1 were allocated across five system size categories,
as well as across ground water and surface water (and ground water
under the direct influence of surface water (GWUDI)) systems, to
provide coverage of differences in vulnerability that may exist. See
Exhibit 8 for the sample allocation across system size and source water
categories. Each size category was given equal importance with 60
systems selected from each size category, and with the selected systems
distributed evenly between surface water and ground water systems
wherever possible (i.e., 30 ground water and 30 surface water systems
were targeted to be selected to monitor for each Screening Survey).
However, when there were not enough systems in a given size/source
category, systems were allocated to the other source within that same
size category. This was the case for small systems because of the
restricted sample pool. This resulted in a uniform sample allocation
across all size categories, with 180 small systems and 120 large
systems in each of the two Screening Surveys. This distribution was
used to provide a balance between population served and the number of
systems. A sampling scheme weighted by population cannot include many
small and very small systems; a scheme weighted by the number of
systems served can include too many small systems at the expense of
large systems (USEPA, 2001c).
Exhibit 8.--UCMR 1 Design Allocation of Systems for Screening Surveys, by Size Category
----------------------------------------------------------------------------------------------------------------
Surface water
Size category Ground water (and GWUDI) Total
systems \1\ systems \2\
----------------------------------------------------------------------------------------------------------------
Sample of Small Systems (serving 10,000 or fewer people)
----------------------------------------------------------------------------------------------------------------
500 and Under................................................... 30 30 60
501 to 3,300.................................................... 30 30 60
3,301 to 10,000................................................. 30 30 60
Subtotal Small Systems...................................... 90 90 180
-----------------------------------------------------------------
Large Systems (serving more than 10,000 people)
----------------------------------------------------------------------------------------------------------------
10,001 to 50,000................................................ 30 30 60
50,001 and over................................................. 30 30 60
[[Page 49112]]
Subtotal Large Systems...................................... 60 60 120
-----------------
Total................................................... 150 150 300
----------------------------------------------------------------------------------------------------------------
\1\ Includes systems with all of their water supplied by a ground water source.
\2\ Includes systems with all or part of their source water supplied by surface water or GWUDI.
b. Proposed Screening Survey Statistical Approach for UCMR 2. To
increase the statistical strength of the Screening Survey sample, EPA
proposes to include additional PWSs in the Screening Survey under UCMR
2. The sample size will be increased in two ways to ensure the data can
be used to support regulatory determinations and rule development, if
warranted. Thus, if a contaminant of concern is found to occur with
some significance during the Screening Survey, EPA may choose not to
conduct Assessment Monitoring and move to make a regulatory
determination based on these data to protect public health more
quickly.
The proposed new Screening Survey design also accounts for possible
laboratory capacity issues related to the use of uncommon methods. The
Screening Survey will be conducted across two years, rather than the
one-year implementation period that was established under UCMR 1.
Spreading the monitoring across two years will reduce the burden on the
limited number of laboratories that will be capable of using these
uncommon methods. In today's proposed rule, only one Screening Survey
list is included, as compared to UCMR 1, in which separate Screening
Survey lists were issued for chemical and microbial monitoring. As
shown in the UCMR 2 time line in section III.K, Exhibit 10, EPA has
left open the possibility of a second Screening Survey later in the
UCMR 2 monitoring cycle, if necessary.
The proposed design increases confidence in the sampling results in
two ways. First, the Screening Survey would use a larger stratified
random sample of approximately 800 systems (compared to 300 under UCMR
1), allocated across five strata for systems serving 100,000 or fewer
people. The sample size is derived from the same rationale as that for
Assessment Monitoring, but the sample frame is expanded to include
large systems serving between 10,001 and 100,000 people. Second, the
Screening Survey will include a census of the largest PWSs, those
serving more than 100,000 people (322 systems), referred to within this
section as ``very large'' systems. Using a census of these very large
systems will minimize the possibility of missing contaminant occurrence
at the systems that serve the largest portion of the population, while
keeping the number of systems required to conduct the Screening Survey
relatively small. No small systems (those serving 10,000 or fewer
people) will be selected to participate in more than one component of
UCMR 2 (i.e., will monitor for only Assessment Monitoring or the
Screening Survey).
The sample of 800 systems serving 100,000 or fewer people will be
divided uniformly among 10 strata (as used in past Screening Surveys
under UCMR 1; see Exhibit 8). With the census of the systems serving
100,001 people or more (approximately 322), plus the sample of 800
systems, 1,122 water systems will monitor for the Screening Survey
under UCMR 2.
Exhibit 9.--Allocation of Systems for Screening Survey, List 2 Contaminants
----------------------------------------------------------------------------------------------------------------
Total systems
Size category Ground water Surface water (including
systems \1\ GWUDI) \2\
----------------------------------------------------------------------------------------------------------------
Sample of Small Systems (serving 10,000 or fewer people)
----------------------------------------------------------------------------------------------------------------
50 and under.................................................... 80 80 160
501 to 3,300.................................................... 80 80 160
3,301 to 10,000................................................. 80 80 160
-----------------
Subtotal Small Systems Sample............................... 240 240 480
-----------------------------------------------------------------
Sample of Large Systems (serving 10,001 to 100,000 people)
----------------------------------------------------------------------------------------------------------------
10,001 to 50,000................................................ 80 80 160
50,001 to 100,000............................................... 80 80 160
-----------------
Subtotal Large Systems Sample............................... 160 160 320
-----------------------------------------------------------------
Census of Very Large Systems (serving greater than 100,000 people)
----------------------------------------------------------------------------------------------------------------
100,001 and over................................................ 61 261 322
-----------------
Grand Total............................................. 461 661 1,122
----------------------------------------------------------------------------------------------------------------
\1\Includes systems with all of their water supplied by a ground water source.
\2\Includes systems with all or part of their source water supplied by surface water or GWUDI.
[[Page 49113]]
3. What Is UCMR Pre-Screen Testing?
The third tier of UCMR 1, Pre-Screen Testing, was envisioned for
use with methods that were in the early stages of development, and/or
methods that were very specialized or limited in applicability. It was
to be conducted by up to 200 PWSs that would be identified by State
agencies as vulnerable to the List 3 contaminants. This testing would
be a targeted sampling to assess occurrence in the most vulnerable
settings, and could help to guide the next steps for contaminant
evaluation as well as methods development. Although no Pre-Screen
Testing has been scheduled to date, nor has any been proposed in this
action, the Pre-Screen Testing design could still be a useful way to
monitor for emerging contaminants with highly technical, specialized
methods. Therefore, the rule retains the language related to Pre-Screen
Testing that was part of the original rule.
4. What Are the Other Applicability Considerations?
Applicability criteria for UCMR 2 remain similar to those under
UCMR 1. The survey design for the Screening Survey is slightly
different than that under UCMR 1, as described in section III.F.2.
Specific UCMR 2 applicability criteria are described in Sec. Sec.
141.40(a)(1) and (2) of today's proposed action. Notable changes or
clarifications to the applicability criteria include the establishment
of a clear date for rule applicability; a requirement to notify EPA in
the case of changes to applicability; and clarification regarding the
definition of system population, as follows:
a. New Applicability Date. The applicability requirements for PWSs
under UCMR 1 provided distinct criteria (e.g., system size, water
source, etc.) which helped determine whether a system could be subject
to UCMR monitoring requirements. However, a specific date was not
prescribed in the UCMR 1 regulation to establish a cutoff date by which
systems did or did not fit these criteria. This created uncertainty
defining applicability over the course of the three-year monitoring
period (2001-2003). EPA is proposing in Sec. 141.40(a) to establish
the UCMR 2 applicability criterion that includes a specific
applicability date of June 30, 2005, at which point a defined list of
PWSs will be established as subject to the rule requirements.
b. Notice Regarding Changes to Applicability Required. The proposed
rule also includes an allowance for adjustments to a system's
applicability status through reporting requirements in Sec.
141.35(b)(2). During the course of UCMR 2 implementation, if a change
occurs at a system that affects UCMR applicability or specific
monitoring requirements (such as a change of source water, or closure
of a sampling location), the system can send a letter to EPA explaining
the changes and requesting appropriate changes to its monitoring
requirements. However, to ensure that a system does not mistakenly
discontinue monitoring, today's proposed action specifies that the
system must continue to monitor according to established requirements
until it receives written approval from EPA to change its requirements.
EPA will address these requests on a case-by-case basis.
c. Definition of System Population. Under UCMR 1, large PWSs were
defined as those systems that served a population of more than 10,000
individuals and small PWSs were those that served 10,000 or fewer
people. While this included the sum of the population served by the
combined distribution system this requirement was occasionally
misunderstood. In today's proposed action EPA has explained more
clearly that ``population served'' is the sum of the retail population
served directly by the PWS plus the population served by any
consecutive system(s) receiving all or part of its finished water from
that PWS. As was established in the proposed Stage 2 Disinfectants and
Disinfection Byproducts Rule (68 FR 49547, August 18, 2003 (USEPA,
2003b)) EPA defines a ``consecutive system'' as a public water system
that buys or otherwise receives some or all of its finished water from
one or more wholesale systems.
G. When Must Monitoring Be Conducted?
1. Timing of Monitoring
The timing of monitoring is a critical aspect of UCMR
implementation. Similar to UCMR 1, the UCMR 2 program will have two
components: Assessment Monitoring for List 1 contaminants, to be
conducted July 2007-June 2010; and the Screening Survey for List 2
contaminants, to be conducted July 2007-June 2009.
For each component of UCMR 2, participating systems will collect
samples as follows:
Surface water sampling locations (including all sampling
locations for which some or all of the water comes from a surface water
or GWUDI source) will be sampled four times, three months apart, during
a continuous 12-month period. These locations must be sampled in either
the first, second, or third month of four consecutive quarters.
Therefore, a system could conduct monitoring in either: (1) January,
April, July, October; (2) February, May, August, November; or (3)
March, June, September, December.
Ground water sampling locations (including only those
sampling locations at which all of the water comes from a ground water
source) will be sampled two times, for six months apart, during a
continuous 12-month period.
The specific days of the week for sample collection and shipping
are limited to ensure sample quality. Under both UCMR 1 and today's
proposed UCMR 2, systems cannot collect samples on Friday, Saturday, or
Sunday. The reason stated within the UCMR 1 language was that samples
needed to be shipped and received at the laboratory within 30 hours of
sampling to accommodate requirements for the sampling of
microbiological parameters, as well as to assure that the samples were
received within the required temperature range. A 30-hour turn-around
time is sometimes not possible to achieve and there are no
microbiological parameters included in this action. Therefore today's
action proposes to replace the 30-hour turn-around time with the
requirement that samples be shipped and received at the laboratory at
the required temperature to maintain sample quality.
2. Individual PWS Monitoring Schedules
Based on lessons learned during UCMR 1 implementation, EPA intends
to establish schedules for large system monitoring to ensure adequate
laboratory capacity for the analysis of UCMR contaminants, and to
improve the oversight of monitoring and data reporting. Under UCMR 1,
EPA specified the year and months in which small systems would monitor,
for both Assessment Monitoring and the Screening Surveys, to ensure
coverage related to spatial and temporal monitoring, and to enable
scheduling of laboratory analyses and shipping of sampling materials
(all of which EPA paid for). However, schedules for large systems only
specified a particular year for Screening Surveys. For Assessment
Monitoring, large systems could select their year and months of
monitoring, within a three-year window. Large systems were not required
to notify EPA of their Assessment Monitoring schedule, and many opted
to conduct monitoring during the last possible year, which created some
implementation problems. EPA was not able to project
[[Page 49114]]
the numbers of PWSs or identify the individual PWSs that had failed to
comply with the UCMR 1 requirements until well into the final
monitoring year, making compliance assistance more difficult. Greater
scheduling flexibility was believed justified for UCMR 1 because the
majority of the approved UCMR 1 analytical methods were also approved
for established compliance monitoring. This flexibility allowed for
possible cost savings on laboratory fees and sample collection burden.
In contrast, UCMR 2 methods are not appropriate for compliance
monitoring (with the exception of Method 525.2, which has been added to
allow for the monitoring of both the acetanilide degradates, and the
parent compounds).
EPA will use the State Monitoring Plans \4\ to identify all small
and large systems that will participate in the UCMR program, and to
identify the monitoring schedule for each system. More specifically,
EPA will send each State an initial State Monitoring Plan that lists
all small and large systems that are subject to the UCMR requirements,
and an initial schedule for sampling (year and months) for each system.
In the initial State Monitoring Plans for each State, approximately
one-third of the PWSs will be scheduled to conduct Assessment
Monitoring in each continuous 12-month period during July 2007 through
June 2010 and approximately one-half of the PWSs will be scheduled to
conduct the Screening Survey in each continuous 12-month period during
July 2007 through June 2009. States that enter into Partnership
Agreements (PAs) with EPA will have the option to review and revise PWS
monitoring schedules as part of their modifications to the State
Monitoring Plans.
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\4\ Under UCMR 1, initial State Monitoring Plans included
tabular listings of the small systems selected to conduct Assessment
Monitoring and listings of all systems (small and large) selected to
conduct Screening Survey monitoring. Initial State Monitoring Plans
also included instructions to States for revising and/or correcting
their State Monitoring Plans, including modifications to sampling
schedules for small systems. EPA incorporated revisions from States
and returned the final State Monitoring Plans to each State.
---------------------------------------------------------------------------
EPA will incorporate State revisions to the final State Monitoring
Plans, including the sampling schedule revisions, if system
participation is allocated approximately evenly across the years of
monitoring. PWSs will be notified of their schedules by either EPA or
the State, as determined through PAs (see section III.I of today's
action for discussion of PAs). Large PWSs that meet the UCMR 2
applicability criteria will be required to conduct UCMR 2 Assessment
Monitoring, regardless of whether they are notified of a sampling
schedule by EPA or the State.
Large systems will have 210 days from the publication of the final
rule to revise their schedule using the EPA electronic data reporting
system. Following this 210-day period, if a large PWS cannot sample
according to the required schedule (e.g., if a sampling location is
closed for more than 15 days before and after the scheduled
monitoring), the PWS must send a letter to EPA explaining the reason
samples cannot be taken according to the assigned schedule, and
requesting an alternative schedule, either: (1) To UCMR Sampling
Coordinator, USEPA, Technical Support Center, 26 West Martin Luther
King Drive (MS 140), Cincinnati, OH 45268; or (2) by e-mail at [email protected].
H. Where Are Samples Collected?
For UCMR 2 monitoring, EPA proposes that all Assessment Monitoring
sampling locations be entry points to the distribution system (EPTDSs).
Under UCMR 1, ``raw source water'' sampling was allowed (if required by
the State for compliance monitoring of regulated contaminants).
However, if a system monitoring its source water detected any
contaminants above the MRL concentration during UCMR 1 (and treatment
was subsequently applied), the system was required to initiate
monitoring at EPTDSs. EPA proposes to eliminate the option of source
water monitoring under UCMR 2 (except for source water that leaves the
EPTDS untreated) because:
This created confusion and errant reporting for systems
during UCMR 1; and
The methods being proposed for UCMR 2 are generally not
applicable to regulated contaminant monitoring, with the exception of
Method 525.2; thus, UCMR 2 samples cannot be used to meet regulatory
requirements, and no savings can be realized through use of multi-
analyte methods that coincide with those for regulated contaminants.
EPA is proposing that the List 2 Screening Survey sampling
locations be a combination of EPTDSs and distribution system sampling
points. Monitoring for all the List 2 contaminants would be conducted
at EPTDS sampling points. In addition to the EPTDS sampling location,
monitoring for the nitrosamines would also be conducted at a sampling
point location in the distribution system in order to capture the
occurrence of NDMA as a disinfection byproduct (DBP). Both free
chlorine and chloramines have been shown to form NDMA, but the rate of
formation is slow, making it likely that NDMA concentrations will
increase in the distribution system (Mitch and Sedlak, 2002). Thus, EPA
is proposing that systems use their Stage 1 Disinfection Byproduct Rule
(DBPR) maximum residence time sampling locations for the collection of
distribution system samples for nitrosamine analyses. Systems with
multiple treatment plants or sources of disinfected water will have a
distribution system maximum residence time (DSMRT) sampling point
associated with each plant/water source as defined in the Stage 1 DBPR
(Sec. 141.132(b)(1)(i)). However, for some of the water systems that
are required to conduct Screening Survey monitoring, the DSMRT sampling
location may not be previously defined. Water systems that do not apply
a chemical disinfectant, and wholesalers who do not have retail
customers may not have defined DSMRT sampling points in the
distribution system. For those cases, EPA is proposing that the
nitrosamine samples be collected only at EPTDSs. EPA is requesting
comment on whether or not nitrosamine samples should be collected at
both the DSMRT sampling location and the EPTDS location or only at the
DSMRT sampling location.
EPA is also proposing language to allow large systems that use
ground water sources and have multiple EPTDSs to conduct monitoring at
representative entry point(s) rather than at each EPTDS. Many systems
with multiple ground water EPTDSs suggested to EPA during UCMR 1 that
these wells are often representative of the same source of ground water
(e.g., because they come from the same aquifer in the same well field).
To monitor at representative EPTDSs, systems must meet the criteria
specified in Sec. 141.35(c)(3), and receive approval from EPA or the
State (refer to section III.J.1 for a discussion of the criteria and
necessary documentation).
I. What Is the States' Role in the UCMR Program?
Under UCMR 2, EPA is clarifying States' potential role in rule
implementation. EPA will narrow the optional activities under
Partnership Agreements (PAs), formerly referred to as ``Memoranda of
Agreement,'' so that implementation responsibilities will be clearer.
Under UCMR 1, EPA included regulatory language that described some
implementation and oversight activities that States could agree to
through the PA process. However, because the UCMR is a direct
implementation rule, State participation is voluntary. Specific
activities for individual States are
[[Page 49115]]
identified and established through the PAs, not through rule language.
Thus to streamline the language for UCMR 2, EPA has deleted this non-
rule language. EPA has retained the language related to the Governors'
petition process (see Sec. 141.40(b)(1)), and the State-wide waiver
provision (see Sec. 141.40(b)(2)).
One new responsibility under the PAs that States may choose to
accept will be the review and approval of proposals for representative
EPTDSs that are submitted by ground water systems. In addition, EPA
will expand the State Monitoring Plans to include all PWSs that are
subject to UCMR (as compared to UCMR 1 State Monitoring Plans, which
included just those selected for the statistical samples). These
changes are described further below.
1. State Participation in Partnership Agreements (PAs)
The statute provides a role for States in developing a
representative monitoring plan for small systems (SDWA section
1445(a)(2)(C)(i)). In addition, States/Primacy agencies most often have
the best information about PWSs in their State. Through PAs, States can
help EPA implement the UCMR program and help ensure that the UCMR data
used for future regulatory determinations will be of the highest
quality possible. During UCMR 1 implementation, State assistance with
implementation was critical to the success of the program and was
greatly appreciated by the Agency. EPA would like to continue to build
upon these partnerships by soliciting participation from the States
through the PA vehicle for UCMR 2. However, under UCMR 2, EPA plans to
simplify the PAs. The UCMR 1 PA was complex, with 43 assistance tasks
that States could perform or defer to EPA to act on.
2. Activities To Be Included in the UCMR 2 PAs
The PA activity list under UCMR 2 is substantially shorter than
that under UCMR 1 and will include a list of key activities for
partnering States to perform, as discussed in this section. All States
that agree to partner with EPA will be asked to review and provide any
needed revisions to the State Monitoring Plan. Each State may agree to
accept additional responsibilities as documented through each State's
final PA with EPA. The primary potential State activities are discussed
in sections a through c below. In addition, States that have assumed
full partnership responsibilities may assist systems with their
monitoring and reporting requirements, though the systems are
ultimately responsible for compliance with their UCMR requirements.
a. Review and Revision of the Initial State Monitoring Plan. EPA
will send each State an initial State Monitoring Plan that will
identify the statistically selected systems for Assessment Monitoring
and Screening Survey monitoring, and all other large systems that are
subject to UCMR 2 requirements and applicability criteria (see
discussion of UCMR 2 system selection in section III.F of today's
action). For the statistically selected systems, EPA will provide a
list of similar replacement systems from which States can select to
replace systems that may not have been appropriately specified in the
initial plan. If the State agrees to partner with EPA, the State will
be asked to notify EPA that it either accepts the State Monitoring Plan
as is, or provide a written request with proposed modifications to the
plan. Specific timing of the State Monitoring Plan coordination will be
addressed in the PAs. State modifications can include any or all of the
following allowed changes:
Replace or update information on systems. A State can
modify its State Monitoring Plan by removing systems that have
closed, merged, or are purchasing all of their water from another
system. If a State believes there are other reasons for removal from
the initial plan, it will be asked to identify those systems, and
provide an explanation for removal, in the request to modify the
initial plan. If a State believes there are large systems (those
serving more than 10,000 people) within their State that have not
been included on the list of Assessment Monitoring systems, the
State will be asked to identify those systems, and provide an
explanation for their inclusion in the request to modify the initial
plan. Information about the actual or potential occurrence or non-
occurrence of contaminants at a system, or a system's vulnerability
to contamination cannot be used as a basis for removal from or
addition to the plan. For the set of statistically selected systems,
a State will be asked to replace any system it removes with systems
from the replacement list, selecting replacements in the order they
are listed.
Modify the timing of monitoring for systems. A State
may also modify the plan by recommending changes to the timing of
monitoring for any system by selecting an alternative schedule (year
and months) within the years specified for Assessment Monitoring or
the Screening Survey. One reason a State may chose to modify the
timing for system sampling could be to coordinate monitoring with
regulated contaminant compliance monitoring. As long as system
participation is allocated approximately evenly across the years of
monitoring, the schedule can be modified for any system in the
initial plan.
b. Review and Approval of PWS Proposed Representative EPTDS. As
discussed in section III.H, some large systems that use ground water as
a source and have multiple EPTDSs may propose monitoring at
representative entry point(s) rather than at each EPTDS. Large PWSs
that have State-approved alternate EPTDS sampling locations, as
provided for under Sec. Sec. 141.23(a)(1), 141.24(f)(1), and
141.24(h)(1), may submit a copy of documentation from their State 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 an EPTDS
for each well within a well field (resulting in multiple EPTDSs from
the same source, such as an aquifer). The existing approval
documentation from the State or the representative well proposal, as
appropriate, must be submitted to the UCMR Sampling Coordinator within
120 days after publication of the final UCMR 2 regulation. EPA or the
State will review the proposal, coordinate any necessary changes with
the system, and approve the final list of EPTDSs where the system will
be required to monitor. No plan will be final until the system receives
written approval from EPA or the State.
c. Notification and Instructions for Systems. If a State agrees to
notify their systems, then within 30 days of receiving their final
State Monitoring Plan, the State will be asked to notify all systems in
that final plan of their monitoring and reporting requirements under
UCMR, including sampling schedules. In addition, for each small system
in the plan (i.e., those serving 10,000 or fewer people), the State
will be asked to provide instructions on location, frequency, timing of
sampling, use of sampling equipment, and handling and shipment of
samples based on these regulations. EPA will provide States with
guidance and templates for these small system instructions. States that
perform the sampling or change the arrangements for the monitoring at
the small systems in the plan will be asked to address these
alternative monitoring arrangements in their PAs.
As part of the agreement to conduct system notification, partnering
States will be asked to provide an electronic listing of all PWSs that
have been notified within 30 days of that notification. The list should
be e-mailed
[[Page 49116]]
in flat file or standard spreadsheet format (such as Microsoft[reg]
Excel) to: [email protected], and should include the
PWS identification (PWSID) code and the date notification was sent to
each system. A representative sample of the notice letter should also
be included.
3. What If States Do Not Participate in a PA?
Although EPA encourages each State to participate in a PA, States
can choose not to enter into this agreement with EPA. In this event,
the initial State Monitoring Plan that EPA sends the State will become
the final State Monitoring Plan for that State and EPA will manage all
UCMR-related activities, coordinating directly with affected PWSs in
that State.
J. What Are the Data Reporting Requirements?
Under the current unregulated contaminant monitoring program,
reporting requirements exist at Sec. 141.35. Today's proposed action
modifies those requirements to make reported results most useful for
sound scientific analyses of the occurrence of unregulated
contaminants. The proposed UCMR program identifies 15 data elements in
Sec. 141.35(e), Table 1, that must be reported with unregulated
contaminant sample test results. Large systems conducting Assessment
Monitoring must include data elements 1 through 5, and 7 through 15
with each sample result. Large systems conducting Screening Survey must
include elements 1 through 15 with each result. Small systems must
record key data elements on each sample form and bottle. Small systems
conducting Assessment Monitoring must include elements 1 through 5, and
7; and those conducting Screening Survey must include elements 1
through 7. With today's proposed changes to Table 1 in Sec. 141.35(e),
some of the reporting requirements will remain the same, a few are
clarified, some have been removed, and three new additional data
elements are being proposed. A minor change that has been applied to
many of the data elements is a change in nomenclature from
``identification numbers'' to ``identification codes'' to allow for the
instances when alphanumeric identifiers are necessary.
Other additions and clarifications to Sec. 141.35 are proposed for
reporting that is required prior to and during monitoring. The purpose
of these changes is to establish clear, enforceable locations and time
frames for each system's UCMR monitoring, and to ensure that other
critical rule-related information is communicated to EPA, such as
changes to a system's applicability under the rule.
Requirements in today's proposed action that are intended to ensure
communication regarding rule applicability and compliance include
reporting of changes in system status or other factors that affect a
system's requirements under the rule (such as if a system believes it
does not meet the applicability criteria for UCMR); reporting to EPA if
a system believes it is subject to UCMR requirements, yet 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 (e.g., budget constraints, unavailability of sampling location
during scheduled month of monitoring).
Requirements and restrictions in today's proposed action related to
reporting of monitoring data are as follows: Systems cannot report
previously collected sampling data (because compliance with UCMR 2
requires the use of uncommon analytical methods, most of which have
been developed specifically for UCMR 2 contaminants); and systems
reporting more than one set of results for the same sampling location
and event will have the highest of the reported values as the official
result.
EPA is proposing through today's action that large systems report
contact information, sampling location inventory information, and
monitoring results to EPA's electronic data reporting system: http://www.epa.gov/safewater/ucmr/ucmr2/reporting.html. Today's proposed
action also specifies that communications requiring written
explanations or copies of documentation be sent either: (1) To UCMR
Sampling Coordinator, USEPA, Technical Support Center, 26 West Martin
Luther King Drive (MS 140), Cincinnati, OH 45268; or (2) by e-mail at
[email protected]. This information may be entered by
the PWS, their State, laboratory, or other representative of the PWS;
however, the PWSs is ultimately responsible for compliance with this
requirement.
1. What Information Is Required Prior To Monitoring?
a. Contact Information. As with UCMR 1, large systems are required
to report contact information to EPA. Today's proposed action clarifies
that this information must be sent within 90 days of final rule
publication, and specifies that the information must be submitted to
EPA's electronic data reporting system. Today's proposed action also
specifies that for small systems, EPA will send a letter requesting
specific contact information. Those small systems, or the partnered
State, must fill in the required information and return it within 90
days of receiving the request.
b. Sampling Location and Inventory Information. EPA is proposing
that large PWSs provide inventory information for each applicable
sampling location. This information must be reported through EPA's
electronic reporting system within 210 days of final rule publication.
For each sampling location, or for each approved representative
sampling location (see the following section, III.J.1.c for information
about representative sampling locations), large PWSs must submit the
following information: PWSID code; PWS facility identification code;
sampling point identification code; sampling point type identification
code; and sampling location water type.
In addition, large systems that are required to conduct Screening
Survey monitoring must also report the disinfectant(s) used to maintain
a residual in the distribution system for each distribution system
sampling location (see section III.J.3.a for discussion of these
reporting elements). All systems serving more than 10,000 people must
ensure that the information concerning the disinfectants used, are
submitted along with the sample results.
c. Proposals for Ground Water Representative Sampling Locations.
Some large systems that use ground water as a source and have multiple
EPTDSs may propose monitoring at representative entry point(s) rather
than at each EPTDS. Large PWSs that have State-approved alternate EPTDS
sampling locations, as provided for under Sec. Sec. 141.23(a)(1),
141.24(f)(1), and 141.24(h)(1), may submit a copy of documentation from
their State 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 an EPTDS for each well within a well field (resulting in
multiple EPTDSs from the same source, such as an aquifer). The existing
approval documentation from the State or the representative well
proposal, as appropriate, must be submitted to the UCMR Sampling
Coordinator within 120 days after publication of the final UCMR 2
regulation. EPA or the State will review the proposal, coordinate any
[[Page 49117]]
necessary changes with the system, and approve the final list of EPTDSs
where the system will be required to monitor. No plan will be final
until the system receives written approval from EPA or the State.
The proposal must 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). For each
representative sampling location in the proposal, systems must include
the following information: PWSID, facility identification code, and
sampling point identification code. In addition, the proposal must
include supporting documentation, which can include system-maintained
well logs or construction drawings indicating comparable depths
(relative to elevation datum) of screened intervals 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 the
wells are located in a limited geographic area (e.g., all wells within
a 0.5 mile radius) and/or, if available, the hydrogeologic data
indicating time of travel separating the representative well from each
of the individual wells it represents (e.g., all wells within a five-
year time of travel delineation).
2. When Must Monitoring Results Be Reported?
a. Large Systems. Today's proposed action establishes the timing of
large system review and approval of monitoring data, as follows:
Systems must ensure that their laboratory posts the data in EPA's
electronic data reporting system (http://www.epa.gov/safewater/ucmr/ucmr2/reporting.html) within 120 days from the sample collection date;
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,
prior to public release.
b. Small Systems. Because EPA pays for and organizes the small
system testing program, the review and approval step for small systems
differs. Under today's proposed action, small systems would only be
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 will
not be 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.
3. What Data Elements Are Required With the Monitoring Results?
a. New Data Elements. EPA is proposing to add three new data
elements: Water Source Type, Disinfectant Type, and Sample Event Code.
Each is discussed in more detail as follows:
Water Source Type: A system's water source type dictates
the monitoring frequency (i.e., monitoring is conducted during four
consecutive quarters for surface water/GWUDI sampling locations and
twice during the monitoring year for ground water sampling locations).
Reporting of this data element will help EPA ensure that systems are
collecting samples at the required frequency. Systems are required to
report either of the following codes for each sampling location:
--SW = surface water (to be reported if the sampling location is served
all or in part by a surface water source);
--GW = ground water (to be reported if the sampling location is served
entirely by a ground water source); and
--GU = GWUDI (to be reported for water facilities that are served all
or in part by ground water under the direct influence of surface
water).
Disinfectant Residual Type: This data element will
identify the type of disinfectant used to maintain a residual in the
distribution system. The nitrosamine, NDMA (one of the Screening Survey
contaminants), has been shown to form in chlorinated or chloraminated
water as a DBP. Thus, EPA is interested in identifying the type of
disinfectant used to maintain a disinfection residual in the
distribution system, including whether a disinfectant residual is
applied. Reporting of this data element only applies to those systems
that are subject to Screening Survey monitoring. These systems will be
required to verify that each of the disinfectant code(s) that indicate
the type or types of treatment used to maintain a disinfectant residual
in the distribution system be reported for each Screening Survey
sampling location, as follows:
--CL = chlorine;
--CA = chloramine;
--OT = all other types of disinfectant (e.g., chlorine dioxide); and
--ND = no disinfectant used.
Sample Event Code: This code will provide EPA with a
unique identifier to associate reported field sample analytical results
with a sampling event and, thus, allow the Agency to track whether
scheduled monitoring has been completed. Using this code, PWSs will be
required to keep EPA informed of any problems with their monitoring
schedule for any given sampling event. For example, if resampling was
needed due to problems with laboratory analyses, the system must inform
EPA of which scheduled sampling event was being fulfilled by the
results of the (unscheduled) resampling by using the Sample Event Code.
b. Unchanged Data Elements. There will be no changes to the
reporting requirements for the following data elements: Public Water
System Identification (PWSID) code, Sample Collection Date, Analytical
Method Code, and Analytical Results--Sign.
c. Modified Data Elements. The following data reporting elements
have been modified.
Public Water System Facility Identification Code--Sampling
Point Identification Code and Sampling Point Type Identification:
During UCMR 1, Public Water System Facility Identification Code--
Sampling Point Identification Code, and Sampling Point Type
Identification were all contained in the same data element. EPA is
proposing to separate these into three individual data elements, and to
clarify the meaning of each, with changes that include:
--for Public Water System Facility Identification Code, a shorter,
clearer definition, with length of the code specified as five digits;
--for Sample Point Identification Code, a revised definition which
specifies that the same identification code must be used consistently
for all current and future unregulated contaminant monitoring to
represent the UCMR sampling location; and
--for Sampling Point Type Identification Code, a limitation for UCMR 2
to ``EP'' for entry point to the distribution system and ``MR'' for
Stage 1 DBPR maximum residence time in distribution system because
sampling under UCMR 2 will be limited to those two sampling locations.
Eliminating codes for other sampling point types is intended to reduce
confusion.
Sample Identification Code: The size of the Sample
Identification Code
[[Page 49118]]
has been expanded to include an alphanumeric value of up to 30
characters (formerly capped at 15) assigned by the laboratory. The
sample identification code will uniquely identify containers, or groups
of containers, which hold the water samples collected at the same PWS/
facility/sampling location during the same sample collection date. This
proposed action clarifies that the sample identification code must be
unique to the sampling event within a PWS for each laboratory. A
laboratory may not use the same sample identification code for more
than one sampling event.
Contaminant/Parameter: Because there are no water quality
parameters being monitored in this proposed regulation, the
Contaminant/Parameter data element is being revised to remove
``Parameter'' from the data element name, and the definition is being
revised to reflect this change.
Analytical Result--Value: Because the requirement to
report the MRL is being removed, the definition of Analytical Result--
Value is being revised to remove the requirement to report the MRL when
the analytical result is less than the MRL.
Sample Analysis Type: Sample Analysis Type is proposed to
be revised to better reflect the type of sample collected. Previously,
this data element could have four values: RFS (raw field sample), RDS
(raw duplicate sample), TFS (treated field sample), or TDS (treated
duplicate sample). These values were reported by the laboratory, which
proved to be problematic, since the laboratory did not possess enough
knowledge about the PWS treatment system or the location from which the
sample was taken to be able to properly assign the correct sample
analysis type. EPA is proposing to change the reporting requirements
such that laboratories will be able to better define the sample
analysis type with the following:
--FS = Field Sample, collected to fulfill the UCMR monitoring
requirements;
--LFSM = Laboratory Fortified Sample Matrix, UCMR field sample with a
known amount of the contaminant of interest added, associated with
precision and accuracy;
--LFSMD = Laboratory Fortified Sample Matrix Duplicate, duplicate of
the laboratory fortified sample matrix; and
--CF = Concentration Fortified, the concentration of a known
contaminant added to a field sample.
This change will allow EPA to collect quality control information at
the FS level instead of a laboratory batch level, and will allow EPA to
know which UCMR FS was fortified. One UCMR FS should be fortified in
duplicate within each analytical batch containing a UCMR sample. EPA
will calculate precision and accuracy of the aggregate UCMR 2
monitoring data using the individual quality control data reported by
systems.
Laboratory Identification Code: This data element was
formerly part of the Sample Batch Identification Code. Since batch
identification is being eliminated, Laboratory Identification Code is
being kept as a stand-alone data element. The value will be an EPA-
assigned laboratory identification code.
d. Data Elements No Longer Reported. EPA is proposing to no longer
use the following eight data elements: Analytical Result--Unit of
Measure; Minimum Reporting Level (MRL); MRL Unit of Measure; Sample
Batch Identification Code; Analytical Precision; Analytical Accuracy;
and Presence/Absence.
Analytical Result--Unit of Measure, Minimum Reporting
Level (MRL), and MRL Unit of Measure: Each of these data elements are
predefined by today's proposed action. All laboratories analyzing UCMR
samples will use the same MRL and unit of measure for UCMR analyses.
EPA's electronic data reporting system will be populated with the
correct values for MRL and unit of measure, so there is no need to
report these data elements.
Sample Batch Identification Code, Analytical Precision,
and Analytical Accuracy: These data elements are related to laboratory
quality control information and laboratory batches. To simplify
reporting, EPA is removing requirements to report batches. With the
removal of batches, the reporting of associated quality control data
such as accuracy and precision will change. Accuracy and precision will
be automatically calculated by the data system as follows:
--Precision: Analytical precision will be calculated from reported
results for LFSM and LFSMD. Precision is the degree of agreement
between two repeated measurements and is monitored through the use of
duplicate fortified samples. For purposes of the UCMR, analytical
precision is defined as the relative percent difference (RPD) between
spiked duplicates analyzed in the same batch of samples as the
analytical result. Precision is calculated as RPD between fortified
matrix duplicates using:
RPD = [(X1 - X2) / {(X1 +
X2)/ 2{time} ] x 100
Where:
X1 is the measured concentration of the LFSM; and
X2 is the measured concentration of the LFSMD.
--Accuracy: Analytical accuracy will be calculated from reported
results for FS, LFSM, and CF. For purposes of the UCMR, analytical
accuracy is defined as the percent recovery of the contaminant in the
LFSM analyzed in the same analytical batch as the associated FS result
and calculated using:
% recovery = [(concentration found in fortified sample - concentration
found in sample)/ concentration fortified] x 100.
Presence/Absence: This previously reserved data element
was removed from the required list, as there are no analyses currently
proposed on UCMR 2 that would require a presence/absence indicator.
K. Time Line of UCMR Activities
Monitoring under UCMR 2 is scheduled for July 2007 through June
2010. Preparation will begin prior to 2007 and will include
coordination of laboratory approval, selection of representative
samples of systems, development of State Monitoring Plans, and
notification of participating PWSs. Assessment Monitoring for List 1
contaminants will be conducted from July 2007 through June 2010. The
Screening Survey for List 2 contaminants will be conducted from July
2007 through June 2009. Exhibit 10 illustrates the major activities
that will take place in preparation for and during implementation of
UCMR 2.
BILLING CODE 6560-50-P
[[Page 49119]]
[GRAPHIC] [TIFF OMITTED] TP22AU05.003
BILLING CODE 6560-50-C
[[Page 49120]]
To minimize the impact of the rule on small systems (those serving
10,000 or fewer people), EPA will pay for the sample kit preparation,
sample shipping fees, and analysis costs for these systems. In
addition, no small system will be required to monitor for more than one
monitoring list of UCMR 2. Large systems (those serving more than
10,000 people) will pay for the cost of shipping and laboratory
testing. Large systems will be responsible for reviewing, approving,
and submitting (i.e., ``reporting'') monitoring results to EPA. Large
systems have 60 days from when the laboratory posts the data to then
review, approve, and submit the data to the State and EPA, via EPA's
electronic data reporting system. If they do not electronically approve
the laboratory data within 60 days of the laboratory's posting to EPA's
electronic reporting system, the data will be considered approved and
final for EPA review. EPA and the State will conduct its quality
control review of the data for 60 days after the system reports the
data. This will also allow for quality control review by States. After
the quality control review, EPA will place the data in the national
NCOD at the time of the next database update.
1. Assessment Monitoring
Assessment Monitoring for List 1 contaminants will conducted from
July 2007 through June 2010 by all large systems (those systems serving
more than 10,000 people), and by a nationally representative sample of
800 small systems (those serving 10,000 people or fewer). Samples will
be collected from EPTDSs. However, as clarified in today's proposed
action, large ground water systems with multiple EPTDSs may be
permitted to sample at representative sampling locations for each
ground water source, as long as those sites have been approved by EPA
or the State. Samples at ground water locations will be collected twice
during a designated consecutive 12-month period. Samples at locations
that are fed in whole or part by a surface water or GWUDI source will
be collected quarterly during a designated consecutive 12-month period.
Large system schedules (year and months of monitoring) will be
determined by EPA in conjunction with the States (as described in
section III.G.2 of today's action). The Agency will schedule and
coordinate small system monitoring, working closely with partnering
States. State Monitoring Plans will provide a venue for States to
review and revise the initial sampling schedules that EPA proposes. The
11 proposed List 1 contaminants to be monitored under Assessment
Monitoring are:
1,3-dinitrobenzene
2,2',4,4'-tetrabromodiphenyl ether (BDE-47)
2,2',4,4',5-pentabromodiphenyl ether (BDE-99)
2,2',4,4',5,5'-hexabromobiphenyl (245-HBB)
2,2',4,4',5,5'-hexabromodiphenyl ether (BDE-153)
2,2',4,4',6-pentabromodiphenyl ether (BDE-100)
2,4,6-trinitrotoluene (TNT)
Dimethoate
Hexahydro-1,3,5-trinitro-1,3,5-triazine (RDX)
Perchlorate
Terbufos sulfone
2. Screening Survey
Sampling under the Screening Survey for List 2 contaminants will be
conducted from July 2007 through June 2009 by all PWSs serving more
than 100,000 people, and by a stratified random sample of 800 PWSs
serving 100,000 or fewer people. Samples collected at EPTDSs will be
analyzed for the 15 contaminants listed below. Because the nitrosamine
NDMA can be formed in chlorinated or chloraminated water as a DBP, the
concentration may increase as the water travels through the
distribution system (Mitch and Sedlak, 2002). Thus, EPA proposes an
additional sampling location for the nitrosamines at the DSMRT sampling
point defined under the Stage 1 DBPR for each treatment plant that is
required to sample for DBPs. For plants that are not required to
monitor for DBPs either because the water is not chemically disinfected
or because the water is sold directly to another water system, the
sampling location for the nitrosamines will be at the EPTDS; no DSMRT
sample will be required. Samples at ground water locations will be
collected twice during a designated consecutive 12-month period.
Samples at locations that are fed in whole or part by a surface water
or GWUDI source will be collected quarterly during a designated
consecutive 12-month period. The 15 proposed List 2 contaminants to be
monitored under the Screening Survey are:
Acetochlor
Acetochlor ESA
Acetochlor OA
Alachlor
Alachlor ESA
Alachlor OA
Metolachlor
Metolachlor ESA
Metolachlor OA
N-nitroso-diethylamine (NDEA)
N-nitroso-dimethylamine (NDMA)
N-nitroso-di-n-butylamine (NDBA)
N-nitroso-di-n-propylamine (NDPA)
N-nitroso-methylethylamine (NMEA)
N-nitroso-pyrrolidine (NPYR)
A summary of the estimated number of systems to monitor under each
UCMR 2 component is listed in Exhibit 11.
Exhibit 11.-- Systems To Participate in UCMR 2 Monitoring
----------------------------------------------------------------------------------------------------------------
Assessment monitoring Screening survey Pre-screen
--------------------------------------------------- testing
System size ----------------- Total \2\
List 1 (July 2007-June 2010) List 2 (July 2007- List 3 (TBD
June 2009) \1\)
----------------------------------------------------------------------------------------------------------------
Small Systems:
25-10,000.................. 800 selected systems......... 480 selected TBD............ 1,280
systems
(different than
those for List 1).
Large Systems:
10,001-100,000............. All (~2,788)................. 320 selected TBD............ ~2,788
systems.
100,001 and over........... All (~322)................... All (~322)........ TBD............ ~322
--------------------------------
Total.................. ~3,910....................... ~1,122............ TBD............ ~4,390
----------------------------------------------------------------------------------------------------------------
\1\ TBD = To be determined
\2\ Totals are not additive for large systems because all large systems conduct Assessment Monitoring, and a
subset of these will also conduct Screening Survey monitoring.
[[Page 49121]]
IV. Cost and Benefits of Today's Proposed Action
In today's action, EPA proposes a new set of contaminants for
monitoring in the second five-year UCMR monitoring cycle. In addition,
UCMR 2 makes some modifications to the rule design. UCMR 2 Assessment
Monitoring (for List 1 contaminants) will be conducted from July 2007
through June 2010 by 800 systems serving 10,000 or fewer, and by all
systems serving more than 10,000 people. It is assumed for this cost
estimation that one-third of systems will monitor during each of the
three Assessment Monitoring years. The Screening Survey for List 2
contaminants will be conducted from July 2007 through June 2009 by 800
systems serving 100,000 or fewer, and all systems serving more than
100,000 (approximately 320 systems). Small systems (those serving
10,000 or fewer people) will not be subject to more than one component
of UCMR 2 monitoring.
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 record
keeping. 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 today's action, EPA proposes nine analytical methods to monitor
for 26 new UCMR contaminants (including four method options for
perchlorate). Estimated system and EPA costs are based on the
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 73 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.
EPA estimates of laboratory fees are based on consultations with
national drinking water laboratories and the costs of analytical
methods similar to those proposed in today's action, unit costs are as
follows:
------------------------------------------------------------------------
------------------------------------------------------------------------
Assessment Monitoring (List 1):
GC/MS (for 7 contaminants)................................... $225
Perchlorate (for 1 contaminant).............................. 150
Explosives (for 3 contaminants).............................. 225
------
Total.................................................... 600
Screening Survey (List 2):
Nitrosamines (for 6 contaminants)............................ 300
Acetanilide degradates (for 6 contaminants).................. 350
Acetanilide parents (for 3 contaminants)..................... 125
------
Total.................................................... 775
------------------------------------------------------------------------
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 of a 15-pound package.
Additional changes to the rule are expected to affect costs to
small systems as compared to costs under UCMR 1.
There will be no ``Index System'' component to the UCMR 2
program. Under UCMR 1, samples were taken from a group of 30 small
Index Systems during all five years of the monitoring cycle to assess
any trends in temporal occurrence, other data variability, or program
problems. Based on its experience with UCMR 1, EPA is not proposing
Index System monitoring for UCMR 2.
Small systems will only be involved in one component of
monitoring during the five-year cycle. Since there will be a greater
number of systems involved in the program, less monitoring will be
required of each participating system, thus reducing the average cost
per small system.
In preparing the UCMR 2 information collection request (ICR), EPA
relied on standard assumptions and data sources used in the preparation
of other drinking water program ICRs. These include the PWS inventory,
number of sampling points per system, and labor rates. EPA expects that
States 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 implementation period of 2007-2011, EPA estimates
that nationwide, the average annual cost of UCMR 2 is approximately
$8.42 million. These total estimated annual costs (labor and non-labor)
are incurred as follows:
------------------------------------------------------------------------
Average annual
cost for all
Respondent respondents
(2007-2011)
(millions)
------------------------------------------------------------------------
Small Systems (25-10,000), including labor only (non- $0.05
labor costs are paid for by EPA)....................
Large Systems (10,001-100,000), including labor and 4.03
non-labor costs.....................................
Very Large Systems (100,001 and greater), including 1.53
labor and non-labor costs...........................
[[Page 49122]]
States, including labor costs related to 0.49
implementation coordination.........................
EPA, including labor for implementation coordination 2.32
and non-labor for small system testing..............
======================================================
Under Executive Order 12866, [58 FR 51735, (October
4, 1993)] the Agency must determine whether a
regulatory action is ``significant'' and therefore
subject to Office of Management and Budget (OMB)
review and the requirements of the Executive Order.
The Order defines ``significant regulatory action''
as one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100
million or more or adversely affect in a material
way the economy, a sector of the economy,
productivity, competition, jobs, the environment,
public health or safety, or State, local, or Tribal
governments or communities;
(2) Create a serious inconsistency or otherwise
interfere with an action taken or planned by another
agency;
(3) Materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs or
the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of
legal mandates, the President's priorities, or the
principles set forth in the Executive Order.
It has been determined that this rule is not a
``significant regulatory action'' under the terms of
Executive Order 12866 and is therefore not subject
to OMB review.
The information collection requirements in this
proposed rule have been submitted for approval to
the OMB under the Paperwork Reduction Act, 44 U.S.C.
3501 et seq. The ICR document prepared by EPA has
been assigned EPA ICR number of 2192.01.
The information to be collected under today's
proposed rule fulfills the statutory requirements of
section 1445(a)(2) of SDWA, as amended in 1996. The
data to be collected 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 regarding health
effects and 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 IV, Cost and Benefits of the Rule, of
today's proposed action. Respondents to the UCMR 2
will include 1,280 small water systems (800 for
Assessment Monitoring, and 480 for Screening Survey
monitoring), the 3,110 large PWSs, and the 56 States
and Primacy agencies (4,446 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. Most Assessment Monitoring
systems will conduct sampling evenly across July
2007-June 2010 (i.e., one-third in each of the 3
consecutive 12-month periods). Because the
applicable ICR period is 2007-2009, there is one-
half year of Assessment Monitoring activity (i.e.,
January through June of 2010) that is not captured
in the ICR estimates.
Small systems (those serving 10,000 or fewer) that
are selected for UCMR 2 monitoring will sample an
average of 2.2 times per system (i.e., number of
responses per system) across the three-year ICR
period of 2007-2009. The average burden per response
for small systems is estimated to be 3.1 hours.
Large systems (those serving 10,001 to 100,000
people) and very large systems (those serving more
than 100,000 people) will sample and report an
average of 2.5 and 3.6 times per system,
respectively, across the three-year ICR period of
2007-2009. The average burden per response for large
and very large systems are estimated to be 8.9 and
12.9 hours, respectively. The larger burden per
response for the very large systems reflects the
fact that these systems typically have more sampling
locations than large systems. 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 (e.g., responses from systems and States)
is associated with a burden of 10.7 hours, with a
labor plus non-labor cost of $1,609 per response.
The annual average per respondent burden hours and
costs for the ICR period of 2007-2009 are: Small
systems--2.3 hour burden at $57 for labor; large
systems--7.5 hours at $204 for labor, and $1,894 for
analytical costs; very large systems--15.6 hours at
$512 for labor, and $7,392 for analytical costs; and
States--203.2 hours at $11,107 for labor. Annual
average burden and cost per respondent (including
both systems and States) is estimated to be 9.02
hours, with a labor plus non-labor cost of $1,355
per respondent (note that small systems do not pay
for testing costs, so they only incur labor costs).
The Agency estimates the annual burden to EPA for
proposed UCMR program activities during the ICR
years of 2007-2009 to be approximately 9,533 hours,
at an annual labor cost of $0.60 million. EPA's
annual non-labor costs
[[Page 49123]]
are estimated to be $2.8 million. EPA's non-labor costs are primarily
labor cost).Burden means the total time, effort, or
financial resources expended by persons to generate,
maintain, retain, 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.
To comment on the Agency's need for this information,
the accuracy of the provided burden estimates, and
any suggested methods for minimizing respondent
burden, including the use of automated collection
techniques, EPA has established a public docket for
this rule, which includes this ICR, under Docket ID
No. OW-2004-0001. Submit any comments related to the
ICR for this proposed rule to EPA and OMB. See
ADDRESSES section at the beginning of this action
for where to submit comments to EPA. Send comments
to OMB at the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th
Street, NW., Washington, DC 20503, Attention: Desk
Office for EPA. Since OMB is required to make a
decision concerning the ICR between 30 and 60 days
after August 22, 2005, a comment to OMB is best
assured of having its full effect if OMB receives it
by September 21, 2005. The final rule will respond
to any OMB or public comments on the information
collection requirements contained in this proposed
action.
The Regulatory Flexibility Act (RFA) generally
requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the
Administrative Procedure Act or any other statute
unless the agency certifies that the rule will not
have a significant economic impact on a substantial
number of small entities. Small entities include
small businesses, small organizations, and small
governmental jurisdictions.
The RFA provides default definitions for each type of
small entity. Small entities are defined as: (1) A
small business as defined by the Small Business
Administration's (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that
is a government of a city, county, town, school
district or special district with a population of
less than 50,000; and (3) a small organization that
is any ``not-for-profit enterprise which is
independently owned and operated and is not dominant
in its field.'' However, the RFA also authorizes an
agency to use alternative definitions for each
category of small entity, ``which are appropriate to
the activities of the agency'' after proposing the
alternative definition(s) in the Federal Register
and taking comment 5 U.S.C. 601(3)-(5). In addition,
to establish an alternative small business
definition, agencies must consult with SBA's Chief
Counsel for Advocacy.
For purposes of assessing the impacts of today's
proposed rule on small entities, EPA considered
small entities to be PWSs serving 10,000 or fewer
people, because this is the system size specified in
SDWA as requiring special consideration with respect
to small system flexibility. As required by the RFA,
EPA proposed using this alternative definition in
the Federal Register, (63 FR 7605, February 13, 1998
(USEPA, 1998a)), requested public comment, consulted
with the Small Business Administration (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 would be applied to
this regulation as well.
After considering the economic impacts of today's
proposed rule on small entities, I certify that this
action will not have a significant economic impact
on a substantial number of small entities. The small
entities directly regulated by this proposed rule
are PWSs serving 10,000 or fewer people. EPA has
determined that the small entities subject to the
requirements of this proposed rule are a subset of
the small PWSs (those serving 10,000 or fewer
people). The Agency has determined that 1,280 small
PWSs (across Assessment Monitoring and the Screening
Survey), or approximately 2 percent of small
systems, will experience an impact of less than 0.6
percent of revenues/sales; the remainder of systems
will not be impacted.
Although this proposed rule will not have a
significant economic impact on a substantial number
of small entities, EPA nonetheless has tried to
reduce the impact of this rule on small entities. To
ensure that this proposed rule will not have a
significant economic impact on a substantial number
of small entities, EPA will assume all costs for
analyses of the samples and for shipping the samples
from these systems to the laboratories contracted by
EPA to analyze UCMR 2 samples. EPA has set aside
$2.0 million each year from the State Revolving Fund
(SRF) with its authority to use SRF monies for the
purposes of implementing this provision of SDWA.
Thus, the costs to these small systems will be
limited to the labor hours associated with
collecting a sample and preparing it for shipping.
The Agency continues to be interested in the
potential impacts of the proposed rule on small
entities and welcomes comments on issues related to
such impacts.
The evaluation of the overall impact on small
systems, summarized in the preceding discussion, is
further described as follows. EPA analyzed the
impacts for privately-owned and publicly-owned water
systems separately, due to the different economic
characteristics of these ownership types. For
publicly-owned systems, EPA used the ``revenue
test,'' which compares annual system costs
attributed to the rule to the system's annual
revenues. EPA used a ``sales test'' for privately-
owned systems, which involves the analogous
comparison of UCMR-related costs to a privately-
owned system's sales. EPA assumes that the
distribution of the sample of participating small
systems will reflect the proportions of publicly-
and privately-owned systems in the national
inventory. The estimated distribution of the
representative sample, categorized by ownership
type, source water, and system size, is presented
below in Exhibit 12.
[[Page 49124]]
Ground Water
------------------------------------------------------------------------
500 and under........................................ 102
501 to 3,300......................................... 179
3,301 to 10,000...................................... 95
------------------
Subtotal GW...................................... 376
------------------------------------------------------
Surface Water (and GWUDI)
------------------------------------------------------------------------
500 and under........................................ 48
501 to 3,300......................................... 95
3,301 to 10,000...................................... 87
------------------
Subtotal SW...................................... 230
==================
Total of Small Water Systems................. 606
------------------------------------------------------------------------
The basis for the UCMR 2 RFA certification for this proposed rule
is as follows: For the 1,280 small water systems that will be affected,
the average annual costs for complying with this rule represent less
than 0.6 percent of system revenues or sales (the highest estimated
percentage is for surface water/GWUDI systems serving 500 or fewer
people, at 0.53 percent of its median sales). Exhibit 13 presents the
yearly costs to small systems, and to EPA for the small system sampling
program, along with an illustration of system participation for each
year of the UCMR 2 program.
Exhibit 13.--EPA and Small Systems Costs for Implementation UCMR 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost description 2007 2008 2009 2010 2011 Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs to EPA for Small System Program (including Assessment Monitoring, and the Screening Survey)
--------------------------------------------------------------------------------------------------------------------------------------------------------
$1,747,951 $3,495,903 $2,278,325 $530,374 $0 $8,052,553
---------------------------------------
Costs to Small Systems (including Assessment Monitoring, and the Screening Survey)
--------------------------------------------------------------------------------------------------------------------------------------------------------
$122,838 $56,789 $37,731 $9,337 $0 $226,695
---------------------------------------
Total Costs to EPA and Small Systems for UCMR 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
$1,870,789 $3,552,692 $2,316,056 $539,711 $0 $8,279,248
--------------------------------------------------------------------------------------------------------------------------------------------------------
System Monitoring Activity Time Line \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Assessment Monitoring........ \1/3\ PWSs Sample.......... \1/3\ PWSs Sample......... \1/3\ PWSs Sample......... ................. 800
Screening Survey............. \1/2\ PWSs Sample.......... \1/2\ PWSs Sample......... .......................... ................. 480
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total number of systems is 1,280. No small system conducts both Assessment Monitoring and Screening Survey.
System costs are attributed to the additional labor required for
reading about their requirements, monitoring, reporting, and record
keeping. The estimated average annual burden across the five-year UCMR
2 implementation period of 2007-2011 is estimated to be 1.4 hours at
$35 per small system. Average annual cost, in all cases, is less than
0.6 percent of system revenues/sales. As required by the SDWA, the
Agency specifically structured the rule to avoid significantly
affecting small entities by assuming all costs for laboratory analyses,
shipping, and quality control for small entities. As a result, EPA
incurs the entirety of the non-labor costs associated with UCMR 2 small
system monitoring, or 97 percent of small system testing costs.
Exhibits 14 and 15 present the estimated economic impacts in the form
of a revenue test for publicly-owned systems and a sales test for
privately-owned systems, respectively.
[[Page 49125]]
Exhibit 14.--UCMR 2 Relative Cost Analysis for Publicly-Owned Systems (2007-2011)
----------------------------------------------------------------------------------------------------------------
Average
Annual annual Average ``Revenue
System size number of hours per annual cost Test'' \1\
systems system per system (percent)
impacted (2007-2011) (2007-2011)
----------------------------------------------------------------------------------------------------------------
Ground Water Systems
----------------------------------------------------------------------------------------------------------------
500 and under............................................... 20 1.1 $26.38 0.11
501 to 3,300................................................ 36 1.3 33.43 0.02
3,301 to 10,000............................................. 19 1.8 46.50 0.01
-------------------------------------------------------------
Surface Water (and GWUDI) Systems
----------------------------------------------------------------------------------------------------------------
500 and under............................................... 9 2.0 47.45 0.20
501 to 3,300................................................ 19 2.0 50.63 0.04
3,301 to 10,000............................................. 17 2.2 58.46 0.01
----------------------------------------------------------------------------------------------------------------
\1\ The ``Revenue Test'' was used to evaluate the economic impact of an information collection on small
government entities (e.g., publicly-owned systems); costs are presented as a percentage of median annual
revenue in each size category.
Exhibit 15.--UCMR 2 Relative Cost Analysis for Privately-Owned Systems (2007-2011)
----------------------------------------------------------------------------------------------------------------
Average annual Average annual
Annual number hours per cost per ``Sales Test''
System size of systems system (2007- system (2007- 1 (percent)
impacted 2011) 2011)
----------------------------------------------------------------------------------------------------------------
Ground Water Systems
----------------------------------------------------------------------------------------------------------------
500 and under................................... 105 1.1 $26.38 0.30
501 to 3,300.................................... 12 1.3 33.43 0.02
3,301 to 10,000................................. 4 1.8 46.50 .01
-------------------------------------------------
Surface Water (and GWUDI) Systems
----------------------------------------------------------------------------------------------------------------
500 and under................................... 11 2.0 47.45 0.53
501 to 3,300.................................... 1 2.0 50.63 0.03
3,301 to 10,000................................. 1 2.2 58.46 0.01
----------------------------------------------------------------------------------------------------------------
1 The ``Sales Test'' was used to evaluate the economic impact of an information collection on small private
entities (e.g., privately-owned systems); costs are presented as a percentage of median annual sales in each
size category.
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
1 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 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 today's proposed rule
(across the implementation period of 2007-2011), for State, local, and
Tribal governments and the private sector, are estimated to be $8.42
million, of which EPA will pay $2.32 million, or approximately 28
percent. Thus, today's 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 proposed 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, today's
rule is not subject to the requirements of UMRA section 203.
[[Page 49126]]
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 proposed rule does not have Federalism implications. It will
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132.
The cost to State and local governments is minimal, and the rule
does not preempt State law. Thus, Executive Order 13132 does not apply
to this 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 solicits 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.''
EPA has concluded that this proposed rule will have Tribal
implications. However, it will neither impose substantial direct
compliance costs on Tribal governments, nor preempt Tribal law. As
described previously, this proposed rule requires monitoring by all
large systems (i.e., those serving more than 10,000 people); one Tribal
water system (the Navajo Tribal Utility Authority) has been identified
as a large system. This proposal 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.
With regard to the single large Tribal system, EPA estimates the
average annual cost for a large system over the five-year rule period
to be less than $1,500. 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) and represents less than
0.05 percent of average revenue/sales for large systems.
With regard to small Tribal systems that may be selected as part of
the nationally representative sample, EPA estimates the average annual
cost over the five-year rule period to be $35. Such cost is based on
the labor associated with collecting a sample and preparing it for
shipping and represents less than 0.6 percent of average revenue/sales
for small systems. All other small-system expenses (associated with
shipping and laboratory fees) are paid by EPA.
EPA consulted with Tribal officials early in the process of
developing the UCMR program to permit them to have meaningful and
timely input into its development. In developing the original UCMR
rule, EPA held stakeholder meetings and prepared background information
for stakeholder review. EPA sent requests for review of stakeholder
documents to nearly 400 Tribes, Tribal organizations, and small systems
organizations to obtain their input. Representatives from the Indian
Health Service (IHS) Sanitary Deficiency System (SDS) 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 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.
Today's proposed rule, addressing the next 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.
As part of the development of this proposed rule, EPA 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
Indian Health Service and the Native American Water Association.
EPA specifically solicits additional comment on this proposed rule
from Tribal officials.
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, 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 proposed 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 today's
proposed 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
[[Page 49127]]
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.
This proposed 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. However, given EPA's interest in
protecting children's health, as part of the provisions in the rule
allowing State Governors to petition EPA to add contaminants to the
UCMR Contaminant List, EPA is specifically asking Governors to include
any information that might be available regarding disproportional risks
to the health or safety of children. Such information would help inform
EPA's decision making regarding the UCMR Contaminant List.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, Section 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 proposed rulemaking involves technical standards. Therefore,
the Agency conducted a search to identify potentially applicable
voluntary consensus standards. In preparing this proposed action, EPA
searched for consensus methods published by the three major voluntary
consensus method organizations, Standard Methods, Association of
Analytical Communities International, and American Society for Testing
and Materials, that would be acceptable for compliance determinations
under SDWA for the Unregulated Contaminant Monitoring List. However,
EPA identified no such standards. For those parameters included in this
proposed action, EPA was unable to use methods from either EPA or
voluntary consensus method organizations that were applicable to the
monitoring required. Therefore, EPA proposes to use the methods
development that the Agency conducted (described in section III.B),
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 proposed rule ensures that no group within the
population is under-represented.
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, 1999c).
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.
VIII. References
Agency for Toxic Substances and Disease Registry (ATSDR). 1989.
Toxicological Profile for N-Nitrosodimethylamine. Atlanta, GA:
Agency for Toxic Substances and Disease Registry, Public Health
Service, U.S. Department of Health and Human Services. Available on
the Internet at: http://www.atsdr.cdc.gov/toxprofiles/tp141.pdf.
ATSDR. 1995a. Toxicological Profile for 1,3-Dinitrobenzene and
1,3,5-Trinitrobenzene. Available on the Internet at: http://www.atsdr.cdc.gov/toxprofiles/tp74.html.
ATSDR. 1995b. Toxicological Profile for RDX. Available on the
Internet at: http://www.atsdr.cdc.gov/toxprofiles/tp78.html.
ATSDR. 1995c. Toxicological Profile for 2,4,6-Trinitrotoluene.
Available on the Internet at: http://www.atsdr.cdc.gov/toxprofiles/tp81.html.
ATSDR. 2002. Toxicological Profile for Polybrominated Biphenyls
and Polybrominated Diphenyl Ethers (PBBs AND PBDEs)--Draft for
Public Comment. September 2002. Available on the Internet at: http://www.atsdr.cdc.gov/toxprofiles/tp68.html.
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: http://www.asdwa.org/.
Burrows, W. D. 1982. Tertiary treatment of effluent from Holston
AAP industrial liquid waste treatment facility I. Batch carbon
adsorption studies: TNT, RDX, HMX, TAX, and SEX. Technical Report
8207. Document no. ADA121244. U.S. Army Armament Research and
Development Command, NJ.
California Department of Health Services (CADHS). 2002. Studies
on the Occurrence of NDMA in Drinking Water. Available on the
Internet at: http://www.dhs.ca.gov/ps/ddwem/chemicals/NDMA/studies.htm.
[[Page 49128]]
California Environmental Protection Agency (CAEPA). 2002. Draft
Groundwater Information Sheet: N-Nitrosodimethylamine (NDMA).
Prepared By: John Borkovitch, R.G., Revised: October 23, 2002.
Available on the Internet at: http://www.swrcb.ca.gov/gama/docs/ndma_oct2002_rev3.pdf.
Choi, J., S.E. Duirk, and R.L. Valentine. 2002. Mechanistic
studies of N-nitrosodimethylamine (NDMA) formation in chlorinated
drinking water. Journal of Environmental Monitoring. Vol. 4, No. 2.
pp. 249-52.
Choi, J., and R.L. Valentine. 2002a. Formation of N-
nitrosodimethylamine (NDMA) from reaction of monochloramine: a new
disinfection by-product. Water Research. Vol. 36, No. 4. pp. 817-
824.
Choi, J., and R.L. Valentine. 2002b. A kinetic model of N-
nitrosodimethylamine (NDMA) formation during water chlorination/
chloramination. Water Science and Technology. Vol. 46, No. 3. pp.
65-71.
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: http://ehp.niehs.nih.gov/members/2001/suppl-1/49-68darnerud/darnerud-full.html.
Hazardous Substances Database (HSDB). 1986. Complete Record for
Dimethoate. Available on the Internet at: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB.
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.
Mitch, W.A., and D.L. Sedlak. 2002. Formation of N-
Nitrosodimethylamine (NDMA) from Dimethylamine during
Chloramination. Environmental Science and Technology. Vol. 36, No.
4. pp. 588-595.
Scribner, E.A., E.M. Thurman, and L.R. Zimmerman. 2000.
``Analysis of Selected Herbicide Metabolites in Surface and Ground
Water of the United States.'' Kolpin, D.W. (ed.), Special Issue:
Fate and Transport of Agricultural Chemicals in the Mississippi
River Basin: Science of the Total Environment. 248(2,3):159-168.
Available on the Internet at: http://ks.water.usgs.gov/Kansas/pubs/reports/wrir.99-4018B.toxicss2.pdf.
USEPA. 1994. Pesticide Tolerances for Acetochlor; Rules and
Regulations. Federal Register. Vol. 59, No. 56. p. 13654, March 23,
1994.
USEPA. 1995. Method 525.2--Determination of Organic Compounds in
Drinking Water by Liquid-Solid Extraction and Capillary Column Gas
Chromatography/Mass Spectrometry. Available on the Internet at:
http://www.NEMI.gov.
USEPA. 1996a. Pesticide Tolerances for Dimethenamid. Federal
Register. Vol. 61, No. 52. p. 10681, March 15, 1996.
USEPA. 1996b. National Primary Drinking Water Regulations:
Monitoring Requirements for Public Drinking Water Supplies:
Cryptosporidium, Giardia, Viruses, Disinfection Byproducts, Water
Treatment Plant Data and Other Information Requirements. Federal
Register. Vol. 61, No. 94. p. 24354, May 14, 1996.
USEPA. 1997. Announcement of the Draft Drinking Water
Contaminant Candidate List; Notice. Federal Register. Vol. 62, No.
193. p. 52194, October 6, 1997.
USEPA. 1998a. National Primary Drinking Water Regulations:
Consumer 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. 1999a. Federal Facilities Forum Issue: Field Sampling and
Selecting On-site Analytical Methods for Explosives in Water. Office
of Research and Development, Office of Solid Waste and Emergency
Response. Prepared by A.B. Crickett, H.D. Craig, and T.F. Jenkins.
EPA 600-S-99-002. May 1999. Available on the Internet at: http://www.epa.gov/tio/tsp/download/water.pdf.
USEPA. 1999b. Human Health Risk Assessment: Terbufos. Office of
Prevention, Pesticides and Toxic Substances. September 2, 1999.
Available on the Internet at: http://www.epa.gov/pesticides/op/terbufos/_revrisk.pdf.
USEPA. 1999c. 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. 1999d. Dimethoate Revised Risk Assessment. Office of
Prevention, Pesticides and Toxic Substances. December 16, 1999.
Available on the Internet at: http://www.epa.gov/pesticides/op/dimethoate/hedrra.pdf.
USEPA. 1999e. EPA Method 314.0--Determination of Perchlorate in
Drinking Water Using Ion Chromatography. Available on the Internet
at: http://www.epa.gov/safewater/methods/sourcalt.html.
USEPA. 1999f. Revised Chapter for Dimethoate RED. Available on
the Internet at: http://www.epa.gov/pesticides/op/dimethoate/efedrra.pdf.
USEPA. 2000a. 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. 2000b. Science Policy Council Handbook, Peer Review. EPA
100-B-00-001. December 2000. Available on the Internet at: http://epa.gov/osa/spc/htm/rchandbk.pdf.
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. Unregulated Contaminant Monitoring Regulation for
Public Water Systems; Analytical Methods of List 2 Contaminants;
Clarifications to the Unregulated Contaminant Monitoring Regulation;
Correction. Federal Register. Vol. 66, No. 95. p. 27215, May 16,
2001.
USEPA. 2001c. Statistical Design and Sample Selection for the
UCMR 1. EPA 815-R-01-004. August 2001. Available on the Internet at:
http://www.epa.gov/safewater/ucmr/ucmr1/pdfs/guidance_ucmr1_statistical_design.pdf.
USEPA. 2001d. Unregulated Contaminant Monitoring Regulation for
Public Water Systems; Amendment to the List 2 Rule and Partial Delay
of Reporting of Monitoring Results. Federal Register. Vol. 66, No.
171. p. 46221, September 4, 2001.
USEPA. 2002a. 2002 Edition of the Drinking Water Standards and
Health Advisories. EPA 822-R-02-038.
USEPA. 2002b. Unregulated Contaminant Monitoring Regulation for
Public Water Systems; Establishment of Reporting Date. Federal
Register. Vol. 67, No. 48. p. 11043, March 12, 2002.
USEPA. 2002c. EPA Dockets; EPA's New Electronic Public Docket
and Comment System; Notice of Availability. Federal Register. Vol.
67, No. 105. p. 38102, May 31, 2002.
USEPA. 2002d. 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. 2003a. Dimethoate Summary. Office of Prevention,
Pesticides and Toxic Substances. Last updated January 6, 2003.
Available on the Internet at: http://www.epa.gov/pesticides/op/dimethoate/dimethsumm.htm.
USEPA. 2003b. National Primary Drinking Water Regulations: Stage
2 Disinfectants and Disinfection Byproducts Rule; National Primary
and Secondary Drinking Water Regulations: Approval of Analytical
Methods for Chemical Contaminants; Proposed Rule. Federal Register.
Vol. 68, No. 159. p. 49547, August 18, 2003.
USEPA. 2003c. 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: http://www.epa.gov/nerlcwww/ordmeth.htm.
USEPA. 2003d. USEPA Integrated Risk Information System.
Available on the Internet at: http://www.epa.gov/iris/index.html.
Accessed for the following contaminants: Acetochlor--CASRN 34256-82-
1; Alachlor--CASRN 15972-60-8; Dimethoate--CASRN 60-51-5; m-
Dinitrobenzene--CASRN 99-65-0; Hexahydro-1,3,5-trinitro-1,3,5-
triazine (RDX)--CASRN 121-82-4; Metolachlor--CASRN 51218-45-2; N-
Nitrosodimethylamine--CASRN 62-75-9; and, 2,4,6-Trinitrotoluene
(TNT)--CASRN 118-96-7.
USEPA. 2003e. UCMR 2: Contaminant Selection Rationale. Draft
background documentation presented at the UCMR 2
[[Page 49129]]
stakeholder meeting, held on October 29, 2003 in Washington, DC.
USEPA. 2004a. 2004 Edition of the Drinking Water Standards and
Health Advisories. EPA 822-R-04-005.
USEPA. 2004b. EPA Method 314.1--Determination of Perchlorate in
Drinking Water Using Inline Column Concentration/Matrix Elimination
Ion Chromatography with Suppressed Conductivity Detection. Available
on the Internet at: http://www.epa.gov/safewater/methods/sourcalt.html.
USEPA. 2004c. EPA Method 331.0--Determination of Perchlorate in
Drinking Water by Liquid Chromatography Electrospray Ionization Mass
Spectrometry. EPA 815-R-05-007. January 2005. Available on the
Internet at: http://www.epa.gov/safewater/methods/sourcalt.html.
USEPA. 2004d. EPA Method 332.0--Determination of Perchlorate in
Drinking Water Using Ion Chromatography with Suppressed Conductivity
and Electrospray Ionization Mass Spectrometry. Available on the
Internet at: http://www.epa.gov/nerlcwww/ordmeth.htm.
USEPA. 2004e. 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). Available on the Internet at:
http://www.epa.gov/nerlcwww/ordmeth.htm.
USEPA. 2004f. 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:
http://www.epa.gov/safewater/methods/sourcalt.html.
USEPA. 2004g. 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). Available on the Internet at:
http://www.epa.gov/nerlcwww/ordmeth.htm.
USEPA. 2004h. Estimating Potency Scores: An Exercise. Office of
Science and Technology, Health and Ecological Criteria Division.
Draft, June 29, 2004.
USEPA. 2004i. Evaluation of the Lowest Concentration Minimum
Reporting Level (LCMRL) and the Minimum Reporting Level (MRL)
Primary Analyte Analysis. October 2004.
USEPA. 2004j. Statistical Protocol for the Determination of the
Single-Laboratory Lowest Concentration Minimum Reporting Level
(LCMRL) and Validation of the Minimum Reporting Level (MRL). EPA
815-R-05-006.
USEPA. 2004k. UCMR 2 Laboratory Approval Requirement and
Information Document. Available on the Internet at: http://www.epa.gov/safewater/ucmr/ucmr2/index.html.
USEPA. 2005. Drinking Water Candidate Contaminant List 2; Final
Notice. Federal Register. Vol. 70, No. 36. p. 9071, February 24,
2005.
List of Subjects in 40 CFR Part 141
Environmental protection, Chemicals, Indians-lands,
Intergovernmental relations, Radiation protection, Reporting and record
keeping requirements, Water supply.
Dated: August 12, 2005.
Stephen L. Johnson,
Administrator.
For the reasons set out in the preamble, title 40, chapter 1 of the
Code of Federal Regulations is proposed to be amended as follows:
PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS
1. The authority citation for part 141 continues to read as
follows:
Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.
Subpart C--[Amended]
2. Section 141.24 is amended by revising paragraphs (h)
introductory text and (h)(7)(v) to read as follows:
Sec. 141.24 Organic chemical, sampling and analytical requirements.
* * * * *
(h) Analysis of the contaminants listed in Sec. 141.61(c) for the
purposes of determining compliance with the maximum contaminant level
shall be conducted as follows:
* * * * *
(7) * * *
(v) If the monitoring results in detection of one or more of
certain related contaminants (heptachlor and heptachlor epoxide), then
subsequent monitoring shall analyze for all related contaminants.
* * * * *
Subpart D--[Amended]
3. Section 141.35 is revised to read as follows:
Sec. 141.35 Reporting for unregulated contaminant monitoring.
(a) General applicability. This section applies to any owner or
operator of a public water system (PWS) required to monitor for
unregulated contaminants under Sec. 141.40(a): Such owner or operator
is referred to as ``you.'' This section specifies the information that
must be reported to EPA prior to the commencement of monitoring, and
describes the process for reporting monitoring results to EPA. For the
purposes of this section, PWS ``population served'' includes the sum of
the retail population served directly by the PWS plus the population
served by any consecutive system(s) receiving all or part of its
finished water from that PWS. For purposes of this section, the term
``State'' refers to the State or Tribal government entity that has
jurisdiction over your PWS even if that government does not have
primary enforcement responsibility for PWSs under the Safe Drinking
Water Act. For purposes of this section, the term ``PWS Official''
refers to the person at your PWS who is able to function as the
official spokesperson for the system's Unregulated Contaminant
Monitoring Regulation (UCMR) activities; and the term ``PWS Technical
Contact'' refers to the person at your PWS who is responsible for the
technical aspects of your UCMR activities, such as details concerning
sampling and reporting.
(b) Reporting by all systems. You must meet the reporting
requirements of this paragraph if you meet the applicability criteria
in Sec. 141.40(a)(1) and (2).
(1) Where to submit UCMR reporting requirement information. Some of
your reporting requirements are to be fulfilled electronically, and
others by mail. Information that must be submitted using EPA's
electronic data reporting system can be accessed through: http://www.epa.gov/safewater/ucmr/ucmr2/reporting.html. Documentation that is
required to be mailed can be submitted either: to UCMR Sampling
Coordinator, USEPA, Technical Support Center, 26 West Martin Luther
King Drive (MS 140), Cincinnati, OH 45268; or by e-mail at [email protected]; or by fax at (513) 569-7191. In
addition, you must notify the public of the monitoring results as
provided in Subpart O (Consumer Confidence Reports) and Subpart Q
(Public Notification) of this part.
(2) Contacting EPA if your system does not meet applicability
criteria or has 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 Sec. 141.40(a)(1) and
(2), or if a change occurs at your system that may affect your
requirements under UCMR as defined in Sec. 141.40(a)(3)-(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. If you meet the applicability
[[Page 49130]]
requirements specified in Sec. 141.40(a)(1) and (2), you are subject
to UCMR requirements until or unless 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 Sec.
141.40(a)(1) and (2)(i), you must meet the reporting requirements in
paragraph (c)(1) through (8) of this section.
(1) Contact information. You must provide contact information by
[DATE 90 DAYS AFTER PUBLICATION OF THE FINAL RULE], 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 [DATE 210 DAYS
AFTER PUBLICATION OF THE FINAL RULE] 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; sampling point identification code;
sampling point type identification code; sampling location water type,
which are 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 State-approved alternate
EPTDS sampling locations, as provided for under Sec. Sec.
141.23(a)(1), 141.24(f)(1), and 141.24(h)(1), may submit a copy of
documentation from their State 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 an EPTDS for each well within a well
field (resulting in 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
[INSERT DATE 120 DAYS AFTER PUBLICATION OF THE FINAL RULE].
(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 comparable depths (relative to
elevation datum) of screened intervals, 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 (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
five-year 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 Sec. 141.40(a)(1) and (2)(i), and you have not been
notified by either EPA or your State by [DATE 150 DAYS AFTER
PUBLICATION OF THE FINAL RULE], 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 Sec. 141.40(a)(1) and (2)(i), you
are subject to the UCMR monitoring and reporting requirements,
regardless of whether or not you have been notified by the State or
EPA.
(5) Notifying EPA if your PWS cannot sample according to schedule.
You may change you Assessment Monitoring (List 1) or Screening Survey
(List 2) schedule up to [DATE 210 DAYS AFTER PUBLICATION OF THE FINAL
RULE] 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 scheduled month of monitoring), 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 requesting an alternative schedule. You are subject to your
assigned UCMR sampling schedule or the schedule that you revised on or
before [DATE 210 DAYS AFTER PUBLICATION OF THE FINAL RULE], until and
unless you receive a letter from EPA specifying a new schedule.
(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. If you are conducting
Assessment Monitoring, you must include data elements 1 through 5, and
7 through 15;
[[Page 49131]]
and if you are conducting Screening Survey, 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 unregulated contaminant analysis 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 in EPA's electronic data reporting system within 120 days from
the sample collection date (sample collection must occur as specified
in Sec. 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 Sec.
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 Sec. 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
Sec. 141.40(a)(3) and using samples collected according to the
approved monitoring plan. Such requirements preclude the possibility of
``grandfathering'' previously collected data.
(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. If this information changes, you
also must provide updates within 30 days of the change.
(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 your UCMR Sampling Coordinator. 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 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 The code used to identify each PWS. The
Identification (PWSID) Code. 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.
2. Public Water System An identification code established by the
Facility Identification Code. 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 identification for all current
and future UCMR monitoring.
3. Water Source Type......... The type of source water that supplies a
water system facility. Systems must
report one of the following codes for
each sampling location:
SW = surface water (to be reported for
water facilities that are served all or
in part by a surface water source).
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).
4. Sampling Point An identification code established by the
Identification Code. State, or at the State's discretion, by
the PWS, 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.
5. Sampling Point Type An identification code corresponding to
Identification Code. the location of the sampling point.
EP = entry point to the distribution
system.
MR = distribution system sample at
maximum residence time.
6. Disinfectant Residual Type The type of disinfectant used 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
[[Page 49132]]
CA = chloramine
OT = all other types of disinfectant
(e.g., chlorine dioxide)
ND = no disinfectant used.
7. Sample Collection Date.... The date the sample is collected,
reported as 4-digit year, 2-digit month,
and 2-digit day.
8. Sample Identification Code 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.
9. Contaminant............... The unregulated contaminant for which the
sample is being analyzed.
10. Analytical Method Code... The identification code of the analytical
method used.
11. Sample Analysis Type..... 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.
12. Analytical Results--Sign. 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.''
13. Analytical Result--Value. The actual numeric value of the analysis
for chemical and microbiological results
for: field samples; laboratory fortified
matrix samples; laboratory fortified
sample matrix duplicates; and
concentration fortified.
14. Laboratory Identification The code, assigned by EPA, used to
Code. identify each laboratory. The code
begins with the standard two-character
State postal abbreviation; the remaining
5 numbers are unique to each laboratory
in the State.
15. Sample Event Code........ 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 GWUDI sources only).
SE4 = represents samples collected to
meet the UCMR monitoring requirement for
the fourth sampling period (surface
water and GWUDI sources only).
------------------------------------------------------------------------
Subpart E--[Amended]
4. Section 141.40 is revised to read as follows:
Sec. 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 are 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'', and ``PWS Technical Contact'' are as defined in Sec.
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 or not
the system purchases all of its water from another system; and its
population served as of June 30, 2005.
(1) Applicability to transient non-community 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 non-
community 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. 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 Sec. 141.35(b)(1) and
(2), respectively.
(A) Assessment Monitoring. You must monitor for the unregulated
contaminants on List 1 of Table 1, Unregulated Contaminant Monitoring
Regulation (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 or not 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 or not you have
been notified by the State or EPA.
[[Page 49133]]
(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 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
6--Period during
1--Contaminant 2--CAS registry 3--Analytical methods 4--Minimum reporting 5--Sampling location which monitoring to
number a level b c be completed
--------------------------------------------------------------------------------------------------------------------------------------------------------
LIST 1: ASSESSMENT MONITORING CHEMICAL CONTAMINANTS
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Dimethoate...................... 60-51-5............... EPA 527 d............. 0.71 [mu]g/L......... EPTDS................ 7/1/2007-6/31/2010.
2. Terbufos sulfone................ 56070-16-7............ EPA 527 d............. 0.44 [mu]g/L......... EPTDS................ 7/1/2007-6/31/2010.
3. 2,2',4,4'-tetrabromodiphenyl 5436-43-1............. EPA 527 d............. 0.33 [mu]g/L......... EPTDS................ 7/1/2007-6/31/2010.
ether (BDE-47).
4. 2,2',4,4',5-pentabromodiphenyl 60348-60-9............ EPA 527 d............. 0.92 [mu]g/L......... EPTDS................ 7/1/2007-6/31/2010.
ether (BDE-99).
5. 2,2',4,4',5,5'-hexabromobiphenyl 59080-40-9............ EPA 527 d............. 0.72 [mu]g/L......... EPTDS................ 7/1/2007-6/31/2010.
(245-HBB).
6. 2,2',4,4',5,5'-hexabromodiphenyl 68631-49-2............ EPA 527 d............. 0.85 [mu]g/L......... EPTDS................ 7/1/2007-6/31/2010.
ether (BDE-153).
7. 2,2',4,4',6-pentabromodiphenyl 189084-64-8........... EPA 527 d............. 0.52 [mu]g/L......... EPTDS................ 7/1/2007-6/31/2010.
ether (BDE-100).
8. 1,3-dinitrobenzene.............. 99-65-0............... EPA 529 e............. 0.76 [mu]g/L......... EPTDS................ 7/1/2007-6/31/2010.
9. 2,4,6-trinitrotoluene (TNT)..... 118-96-7.............. EPA 529 e............. 0.78 [mu]g/L......... EPTDS................ 7/1/2007-6/31/2010.
10. Hexahydro-1,3,5-trinitro-1,3,5- 121-82-4.............. EPA 529 e............. 1.2 [mu]g/L.......... EPTDS................ 7/1/2007-6/31/2010.
triazine (RDX).
11. Perchlorate.................... 14797-73-0............ EPA 314.0 f, g........ 0.57 [mu]g/L......... EPTDS................ 7/1/2007-6/31/2010.
...................... EPA 314.1 h........... ..................... .....................
...................... EPA 331.0 i........... ..................... .....................
...................... EPA 332.0 j........... ..................... .....................
------------------------------------
LIST 2: SCREENING SURVEY CHEMICAL CONTAMINANTS
Acetanilide Pesticide Degradation Products
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Acetochlor ESA.................. 187022-11-3........... EPA 535 k............. 1.4 [mu]g/L.......... EPTDS................ 7/1/2007-6/31/2009.
2. Acetochlor OA................... 184992-44-4........... EPA 535 k............. 1.5 [mu]g/L.......... EPTDS................ 7/1/2007-6/31/2009.
3. Alachlor ESA.................... 142363-53-9........... EPA 535 k............. 1.0 [mu]g/L.......... EPTDS................ 7/1/2007-6/31/2009.
4. Alachlor OA..................... 171262-17-2........... EPA 535 k............. 1.6 [mu]g/L.......... EPTDS................ 7/1/2007-6/31/2009.
5. Metolaclor ESA.................. 171118-09-5........... EPA 535 k............. 1.1 [mu]g/L.......... EPTDS................ 7/1/2007-6/31/2009.
6. Metolachlor OA.................. 152019-73-3........... EPA 535 k............. 1.5 [mu]g/L.......... EPTDS................ 7/1/2007-6/31/2009.
------------------------------------
Acetanilide Pesticide Parent Compounds
--------------------------------------------------------------------------------------------------------------------------------------------------------
7. Acetochlor...................... 34256-82-1............ EPA l................. 2.0 [mu]g/L.......... EPTDS................ 7/1/2007-6/31/2009.
8. Alachlor........................ 15972-60-8............ EPA l................. 1.6 [mu]g/L.......... EPTDS................ 7/1/2007-6/31/2009.
9. Metolachlor..................... 51218-45-2............ EPA l................. 1.0 [mu]g/L.......... EPTDS................ 7/1/2007-6/31/2009.
------------------------------------
Nitrosamines
--------------------------------------------------------------------------------------------------------------------------------------------------------
10. N-nitroso-diethylamine (NDEA).. 55-18-5............... EPA 521 m............. 0.0046 [mu]g/L....... DSMRT and EPTDS...... 7/1/2007-6/31/2009.
[[Page 49134]]
11. N-nitroso-dimethylamine (NDMA). 62-75-9............... EPA 521 m............. 0.0024 [mu]g/L....... DSMRT and EPTDS...... 7/1/2007-6/31/2009.
12. N-nitroso-di-n-butylamine 924-16-3.............. EPA 521 m............. 0.0035 [mu]g/L....... DSMRT and EPTDS...... 7/1/2007-6/31/2009.
(NDBA).
13. N-nitroso-di-n-propylamine 621-64-7.............. EPA 521 m............. 0.0072 [mu]g/L....... DSMRT amd EPTDS...... 7/1/2007- 6/31/2009.
(NDPA).
14. N-nitroso-methylethylamine 10595-95-6............ EPA 521 m............. 0.0034 [mu]g/L....... DSMRT and EPTDS...... 7/1/2007-6/31/2009.
(NMEA).
15. N-nitroso-pyrrolidine (NPYR)... 930-55-2.............. EPA 521 m............. 0.0022 [mu]g/L....... DSMRT and EPTDS...... 7/1/2007-6/31/2009.
------------------------------------
LIST 3: PRE-SCREEN TESTING TO BE SAMPLED AFTER NOTICE OF ANALYTICAL METHODS AVAILABILITY
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. Reserved n...................... Reserved n............ Reserved n............ Reserved n........... Reserved n........... Reserved.n
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 years 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-m 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 Arcives and Records Administration (NARA). For information on availability of this material at NARA, call 202-741-6030,
or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations_html.
a The version of the EPA methods which you must follow for this Regulation are listed in d-m 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 Methods 314.0 and 525.2
were developed prior to UCMR 2, hence the LCMRLs were not determined for analytes determined by these methods.
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 EPTDSs 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.
EPA Method 527 d ``Determination of Selected Pesticides and Flame Retardants in Drinking Water by Solid Phase Extraction and Capillary Column Gas
Chromatography/Mass Spectrometry (GC/MS)'' is available at http://www.epa.gov/safewater/methods/sourcalt.html.
EPA Method 529 e ``Determination of Explosives and Related Compounds in Drinking Water by Solid Phase Extraction and Capillary Column Gas Chromatography/
Mass Spectrometry (GC/MS)'' is available at http://www.epa.gov/nerlcwww/ordmeth.htm.
EPA Method 314.0 f ``Determination of Perchlorate in Drinking Water Using Ion Chromatography'' is available
at http://www.epa.gov/safewater/methods/sourcalt.html.
g All perchlorate samples must be collected using the sterile technique required in Methods 314.1, 331.0, or 332.0.
h EPA Method 314.1 ``Determination of Perchlorate in Drinking Water Using Inline Column Concentration/Matrix Elimination Ion Chromatography with
Suppressed Conductivity Detection'' is available
at http://www.epa.gov/safewater/methods/sourcalt.html.
i EPA Method 331.0 ``Determination of Perchlorate in Drinking Water by Liquid Chromatography Electrospray Ionization Mass Spectrometry'' is available at
http://www.epa.gov/safewater/methods/sourcalt.html.
j EPA Method 332.0 ``Determination of Perchlorate in Drinking Water Using Ion Chromatography with Suppressed Conductivity and Electrospray Ionization
Mass Spectrometry'' is available at http://www.epa.gov/nerlcwww/ordmeth.htm.
k 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)'' is available at http://www.epa.gov/nerlcwww/ordmeth.htm.
l EPA Method 525.2 ``Determination of Organic Compounds in Drinking Water by Liquid-Solid Extraction and Capillary Column Gas Chromatography/Mass
Spectrometry'' is available at http://www.NEMI.gov.
m EPA Method 521 ``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)'' is available at http://www.epa.gov/nerlcwww/ordmeth.htm.
n 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 applicability criteria specified in paragraph (a)(2)(i) of
this section, you must comply with the requirements specified in
paragraphs (a)(4)(i)(A) through (I) of this section. Your samples must
be collected according to the 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 [DATE 210 DAYS AFTER PUBLICATION OF
THE FINAL RULE]. Your schedule must
[[Page 49135]]
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. As specified in Sec. 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 for each sampling location, as specified in Table 2, in
paragraph (a)(4)(i)(B).
Table 2.--Monitoring Frequency by Contaminant and Water Source Types
----------------------------------------------------------------------------------------------------------------
Time frame
Contaminant type Water source type (months) Frequency
----------------------------------------------------------------------------------------------------------------
Chemical............................. Surface water or ground water 12 You must monitor for 4
under the direct influence consecutive quarters. Sample
of surface water (GWUDI) events must occur 3 months
(includes all sampling apart.
locations for which some or
all of the water comes from
a surface water or GWUDI
source).
Ground water................. 12 You must monitor twice in a
consecutive 12-month period.
Sample events must occur 6
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 that table. 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 Sec. 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 Sec. 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 Pre-Screen 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, preserve, and
test each sample separately. If you are using EPA Method 314.0 for
analysis of perchlorate, you must collect the samples using the sterile
techniques that are described in any 1 of the other 3 perchlorate
methods, as specified in Table 1, in paragraph (a)(3) of this section.
(E) Sample collection and shipping time. If you must ship the
samples for testing, 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
analytical methods for List 1, and, if applicable, for List 2, 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 an error occurs
either at the laboratory which precludes its reporting of valid data,
or in sampling for a listed contaminant, you must resample within 14
days of observing the occurrence of the error using the procedures
specified for the method. (This resampling is not for confirmation
sampling, but to correct the sampling or laboratory error.)
(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 Sec. 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 will be
collecting your UCMR samples, you must assist them in identifying the
appropriate sampling locations and in taking 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, 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
[[Page 49136]]
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 Sec. 141.35(d)(2). A copy of
the form must be sent to the laboratory with the samples, and to the
UCMR Sampling Coordinator. You must resample following instructions
that you will be sent from the UCMR Sampling Coordinator or State.
(F) Duplicate samples. EPA will select systems in the State
Monitoring Plan that must collect duplicate samples for quality
control. If your system is selected, you will receive 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 Sec. 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. If you are using EPA Method 314.0 for analysis of perchlorate,
you must collect the samples using the sterile techniques that are
described in any 1 of the other 3 perchlorate methods, as specified 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 and 2. To be approved to
conduct UCMR testing, the laboratory must 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 specified in
column 3 of Table 1, in paragraph (a)(3) of this section; and
successfully 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 [INSERT DATE 90 DAYS AFTER PUBLICATION OF THE
FINAL RULE]. 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
[email protected].
(iii) Minimum Reporting Level. The Minimum Reporting Level (MRL) is
the lowest analyte concentration for which future recovery is predicted
to fall, with high confidence (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 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 is used in these performance validation steps
must be used in all routine sample 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 are 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).
(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:
[[Page 49137]]
[GRAPHIC] [TIFF OMITTED] TP22AU05.004
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). For a certain
number of replicates and for a certain confidence level in Student's t,
this factor 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 constant factor (C) for replicate sample numbers 7
through 10 with a confidence level of 99% for Student's t.
[GRAPHIC] [TIFF OMITTED] TP22AU05.005
(6) The HRPIR is calculated by Equation 2:
[GRAPHIC] [TIFF OMITTED] TP22AU05.006
(7) The PIR is calculated by Equation 3:
[GRAPHIC] [TIFF OMITTED] TP22AU05.007
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]1
------------------------------------------------------------------------
Constant factor (C) to be
Replicates Degrees of multiplied by the standard
freedom deviation
------------------------------------------------------------------------
7............................ 6 3.963
8............................ 7 3.711
9............................ 8 3.536
10........................... 9 3.409
------------------------------------------------------------------------
1 The 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.
(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 quality control (QC) interval (50%),
and the PIR upper recovery limits cannot be greater than the upper
recovery limits of the QC interval (150%). When the PIR recovery limits
fall 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.
(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.
(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 sample, spiked at or below the MRL for
each analyte, must be processed through the entire method procedure.
The measured concentration 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 re-run
the daily performance check sample if the performance for any analyte
or analytes cannot be validated. If performance is validated for these
analytes, then the laboratory performance is considered validated.
Alternatively, the laboratory may re-calibrate and repeat the
performance validation process for all analytes. Laboratories
performing perchlorate analyses using EPA Method 314.0 must, in
addition to the quality control specified in that method, successfully
monitor the Laboratory Synthetic Sample Matrix Blank and the MRL
Laboratory Fortified Synthetic Sample Matrix, as specified in Section
9.3.2 and 9.3.4 of EPA Method 314.1, prior to analysis of samples. The
MRL Laboratory Fortified Synthetic Sample Matrix is intended as a daily
MRL check and only must be run once per analysis batch.
(iv) Laboratory fortified sample matrix and laboratory fortified
sample matrix duplicate. You must ensure that your laboratory prepares
and analyzes the Laboratory Fortified Sample Matrix (LFSM) sample for
accuracy and Laboratory Fortified Sample Matrix Duplicate (LFSMD)
samples for precision to determine method accuracy and precision for
all contaminants in Table 1, in paragraph (a)(3) of this section. LFSM/
LFSMD samples must be prepared using a sample collected and analyzed in
accordance with UCMR 2 requirements and analyzed at a
[[Page 49138]]
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 mid-level, 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 20% of the MRL
for each contaminant (e.g., for an MRL of 1.0 [mu]g/L the acceptable
fortification levels must be between 0.80 [mu]g/L and 1.2 [mu]g/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) Detection Confirmation. Results greater than or equal to the
MRLs specified in column 4 of Table 1 in paragraph (a)(3) of this
section, that are obtained using Methods 314.0 or 314.1, must be
confirmed before being reported. Results using these methods must be
confirmed by Methods 331.0 or 332.0 or by second column confirmation as
detailed in Method 314.1. If confirmation is being performed using the
second column specified in Method 314.1, the laboratory must use one of
the following confirming techniques: perform single point calibration
of the second chromatographic column for confirmation purposes only as
long as the calibration standard is at a concentration within 50% of the concentration determined by the initial analysis; or
perform a three (3) point calibration with single point daily
calibration verification of the second chromatographic column
regardless of whether that verification standard concentration is
within 50% of sample response. However, this calibration
must bracket the concentration of the contaminant observed. The
concentration obtained for the primary column must be reported; if the
concentration observed on the primary column is within 2 times the MRL
and the quantitation of both columns is within 50%, or if
the concentration observed on the primary column is greater than 2
times the MRL and the quantitation of both columns is within 30%. If the quantitation obtained from both columns is not within
50% and the concentration observed on the primary column is
within 2 times the MRL, or if the quantitation obtained from both
columns is not within 30% and the concentration observed on
the primary column greater than 2 times the MRL, the result is to be
reported as ``not reported due to matrix interference,'' as specified
in Table 1, in Sec. 141.35(e). If confirmation is being performed
using either Method 331.0 or 332.0, then the laboratory must report the
Method 331.0 or 332.0 result.
(vi) 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.
(vii) Reporting. You must ensure that the laboratory you use
reports the analytical results and other data, with the required data
listed in Table 1, in Sec. 141.35(e). You must require your laboratory
to submit these data electronically to the State and EPA using EPA's
electronic data reporting system (http://www.epa.gov/safewater/ucmr/ucmr2/reporting.html) within 120 days from the sample collection date.
You have 60 days from when the laboratory posts the data to then
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 EPA review.
(6) Violation of this rule--
(i) Monitoring violations. Any failure to monitor in accordance
with Sec. 141.40(a)(3)-(5) is a monitoring violation.
(ii) Reporting violations. Any failure to report in accordance with
Sec. 141.35 is a reporting violation.
(b) Requirements for State and Tribal participation--
(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. You 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. You may apply to EPA for a State-wide waiver from
the unregulated contaminant monitoring requirements for PWSs serving
more than 10,000 people. To apply for such a waiver, you must submit an
application to EPA that includes the following information: the list of
contaminants on the UCMR Contaminant List for which you request a
waiver, along with documentation for each contaminant in your request
demonstrating that the contaminants or their parent compounds do not
occur naturally in your 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 your State.
(ii) Approval. EPA will review your application and notify you
whether it accepts or rejects your request. You must receive written
approval from EPA before issuing a State-wide waiver.
[FR Doc. 05-16385 Filed 8-19-05; 8:45 am]
BILLING CODE 6560-50-P