Friday
September 17, 1999
Part II
Environmental
Protection Agency
40 CFR Parts 9, 141 and 142
Revisions to the Unregulated
Contaminant Monitoring Regulation for
Public Water Systems; Final Rule
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50556 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
* • ,|» » ., «ii
40 CFR Parts 9,141 and 142
,. ,;• ,' i.. •" .' niii1'"" i i 1
[FRL-6433-1J
RIN204O-AD15
Revisions to the Unregulated
Contaminant Monitoring Regulation for
Public Water Systems
AGENCY; Environmental Protection
Agency.
ACTION: Final rule.
SUMMARY: The Safe Drinking Water Act
(SDWA), as amended in 1996, requires
the U.S. Environmental Protection
Agency (EPA) to establish criteria for a
program to monitor unregulated
contaminants and, by August 6, 1999, to
publish a list of contaminants to be
monitored. To conform to the
Amendments, today EPA is
promulgating the Unregulated
Contaminant Monitoring Regulation
(UCMRJ for Public Water Systems
(PWSs), which revises substantially the
existing regulations for unregulated
contaminant monitoring.
This final rule includes a list of
contaminants to be monitored,
procedures for selecting a representative
nationwide sample of small PWSs that
will be required to monitor, the
frequency and schedule for monitoring,
the sampling points, the approved
analytical methods to be used, and
procedures for entering the monitoring
data in the National Drinking Water
Contaminant Occurrence Database
(NCOD), as required under section 1445
Of SDWA, as amended. The data in the
database will be used to identify
contaminants on the Drinking Water
Contaminant Candidate List (CCL), to
support the Administrator's
determination of whether or not to
develop drinking water standards for a
particular contaminant, and to develop
standards for the contaminants that the
Administrator selects.
DATES: Effective Date: The final rule is
effective January 1, 2001.
For purposes of judicial review, this
final rule is promulgated as on 1 p.m.
Eastern time on October 1,1999 as
provided in 40 CFR 23.7.
The incorporation by reference of the
publications listed in today's rule is
approved by the Director of the Federal
Register as of January 1, 2001.
ADDRESSES: Documents relevant to this
action are available for inspection from
9 a.m. to 4 p.m. Monday through Friday,
excluding legal holidays, at the Water
Docket, East Tower Basement, U.S. EPA,
401 M Street, SW, Washington DC. For
access to docket pocket No. W-98-02)
materials, please call (202) 260-3027
between 9 a.m. and 3:30 p.m, Eastern
Time, Monday through Friday, to
schedule an appointment. A reasonable
fee may be charged for copying.
FOR FURTHER INFORMATION CONTACT:
Charles Job, Standards and Risk
Management Division, Office of Ground
Water and Drinking Water (MC-4607),
U.S. Environmental Protection Agency,
401 M Street, SW, Washington, D.C.
20460, (202) 260-7084. General
information may also be obtained from
the EPA 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 federal holidays, from
9:00 a.m. to 5:30 p.m. Eastern Time.
SUPPLEMENTARY INFORMATION:
Regional Contacts
I. Jane Downing, JFK Federal Bldg., Room
2203, Boston, MA 02203. Phone: 617-
918-1571.
n. Bruce Kiselica, 290 Broadway, Room 2432,
New York, NY 10007-1866. Phone: 212-
637-3879.
m. Michelle Hoover, 1650 Arch Street,
Philadelphia, PA 19103-2029. Phone:
215-814-5258.
IV. Janine Morris, 345 Courtland Street, NE,
Atlanta, GA 30365. Phone: 404-562-
9480.
V. Thomas Poleck, 77 West Jackson Blvd.,
Chicago, IL 60604-3507. Phone: 312-
886-2407.
VI. Larry Wright, 1445 Ross Avenue, Dallas,
TX 75202. Phone: 214-665-7150.
VH. Stan Calow, 726 Minnesota Ave., Kansas
City, KS 66101. Phone: 913-551-7410.
VHI. Rod Glebe, One Denver Place, 999 18th
Street, Suite 500, Denver, CO 80202.
Phone: 303-312-6627.
K. Bruce Macler, 75 Hawthorne Street, San
Francisco, CA 94105. Phone: 415-744-
1884.
X. Gene Taylor, 1200 Sixth Avenue, Seattle,
WA 98101. Phone: 206-553-1389.
Abbreviations and Acronyms Used in
the Preamble and Final Rule
2,4-DNT—2,4-dinitrotoluene
2,6-DNT—2,6-dinitrotoluene
4,4'-DDE—4,4'-dichloro dichlorophenyl
ethylene, a degradation product of DDT
Alachlor ESA—alachlor ethanesulfonic acid,
a degradation product of alachlor
AOAC—Association of Official Analytical
Chemists
APHA—American Public Health Association
ASDWA—Association of State Drinking
Water Administrators
ASTM—American Society for Testing and
Materials
BGM—Buffalo Green Monkey cells, a specific
cell line used to grow viruses
CAS—Chemical Abstract Service
CASRN—Chemical Abstract Service Registry
Number
CCL—Contaminant Candidate List
CCR—Consumer Confidence Reports
., , . . •
CERCLA—Comprehensive Environmental
Response, Compensation & Liability Act
CFR—Code of Federal Regulations
CFU—colony forming unit
CFU/mL—colony forming units per milliliter
CWS—community water system
DCPA—dimethyl tetrachloroterephthalate,
chemical name of the herbicide dacthal
DCPA mono- and di-acid degradates—
degradation products of DCPA
DDE—dichloro dichlorophenyl ethylene, a
degradation product of DDT
DDT—dichloro diphenyl trichloroethane, a
general insecticide
DNA—deoxyribonucleic acid
EDL—estimated detection limit
EPA—Environmental Protection Agency
EPTC—s-ethyl-dipropylthiocarbamate, an
herbicide
EPTDS—Entry Point to the Distribution
System
ESA—ethanesulfonic acid, a degradation
product of alachlor
FACA—Federal Advisory Committee Act
FTE—full-time equivalent
GC—gas chromatography, a laboratory
method
GLI method—Great Lakes Instruments
method
GW—ground water
GWUDI—ground water under the direct
influence (of surface water)
HPLC—high performance liquid
chromatography, a laboratory method
ICR—Information Collection Request/Rule
ERF A—initial regulatory flexibility analysis
IMS—immunomagnetic separation
IRIS—Integrated Risk Information System
IS—internal standard
LLE—liquid/liquid extraction, a laboratory
method
MAC—Mycobacterium avium complex
MOA—Memorandum of Agreement
MCL—maximum contaminant level
MDL—method detection limit
MRL—minimum reporting level
MS—mass spectrometry, a laboratory method
MSD—sample matrix spike duplicate
MTBE—methyl-tertiary-butyl-ether, a
gasoline additive
NAWQA—National Water Quality
Assessment Program
NCOD—National Drinking Water
Contaminant Occurrence Database
NDWAC—National Drinking Water Advisory
Council
NERL—National Environmental Research
Laboratory
NFS—National Pesticide Survey
NTIS—National Technical Information
Service
NTNCWS—non-transient non-community
water system
NTTAA—National Technology Transfer and
Advancement Act
OGWDW—Office of Ground Water and
Drinking Water
OMB—Office of Management and Budget
PAH—Poly-aromatic hydrocarbon
PB—particle beam
PBMS—Performance-Based Measurement
System
pCi/L—picocuries per liter
PCR—polymerase chain reaction
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Federal Register/Vol. 64. No. ISO/Friday, September 17, 1999/Rules and Regulations 50557
2">Pb_Lead-210 (also Pb-210), a lead isotope
and radionuclide; part of the uranium
decay series
ziopo—Polonium-210 (also Po-210), a
polonium isotope and radionuclide; part
of the uranium decay series
PWS—Public Water System
PWSF—Public Water System Facility
QA—quality assurance
QC—quality control
KDX—royal demolition explosive,
hexahydro-l,3,5-trinitro-l,3,5-triazine
RFA—Regulatory Flexibility Act
RPD—relative percent difference
RSD—relative standard deviation
SBREFA—Small Business Regulatory
Enforcement Fairness Act
SD—standard deviation
SDWA—Safe Drinking Water Act
SDWIS—Safe Drinking Water Information
System
SDWIS FED—the Federal Safe Drinking
Water Information System
SM—Standard Methods
SMF—Standard Compliance Monitoring
Framework
SMS—sample matrix spike
SOC—synthetic organic compound
SPE—solid phase extraction, a laboratory
method
SRF—State Revolving Fund
STORET—Storage and Retrieval System
SW—surface water
TBD—to be determined
TNCWS—transient non-community water
system
UCMR—Unregulated Contaminant
Monitoring Regulation/Rule
UCM—Unregulated Contaminant Monitoring
UMRA—Unfunded Mandates Reform Act of
1995
USEPA—United States Environmental
Protection Agency
UV—ultraviolet
VOC—volatile organic compound
Hg/L—micrograms per liter
Preamble Outline
I. Statutory Authority
n. Major Program Revisions
HI. Regulatory Background
IV. Process of Preparing the Final Rule
V. Concise Description of Today's Action
A. Which Systems Must Monitor
B. System Monitoring Requirements
C. System Reporting Requirements
. . D. State and Tribal Participation
VI. Final Changes in the Unregulated
Contaminant Monitoring Program
A. Revised List of Unregulated
Contaminants to be Monitored
1. Criteria for Selecting Contaminants for
the UCMR
(a) Revising the UCMR (1999) List
(b) Regulatory Approach for the UCMR
(1999) List
(c) Analytical Methods Applicable to the
UCMR (1999) List
(i) Chemical Analytical Methods
(ii) Microbiological Analytical Methods
2. List of Contaminants To Be Monitored
(a) Final UCMR (1999) List
(b) Number of Contaminants on the UCMR
(1999) List
B. Public Water Systems Subject to the
UCMR
C. Type of Monitoring Required of Public
Water Systems Based on Listing Group
1. Assessment Monitoring
2. Screening Survey
3. Pre-Screen Testing
D. Monitoring Requirements Under the
Final UCMR
1. Monitoring Frequency
(a) Systems Serving More Than 10,000
Persons
(i) Chemical Contaminants.
(ii) Microbiological Contaminants.
(b) Systems Serving 10,000 or Fewer
Persons
2. Monitoring Time for Vulnerable Period
3. Monitoring Location
(a) Chemical Contaminants
(b) Microbiological Contaminants
4. Quality Control Procedures for Sampling
and Testing
5. Monitoring of Routinely Tested Water
Quality Parameters
6. Relation to Compliance Monitoring
Requirements
7. Previous Monitoring of the
Contaminants on the Final UCMR (1999)
List
E. Waivers
1. Waivers for Systems Serving More than
10,000 Persons
2. Waivers for Small Systems in State Plans
F. Representative Sample of Systems
Serving 10,000 or Fewer Persons
1. System Size
2. System Type
(a) Public Water System Monitoring
(b) Nontransient Non-Community Water
Systems
(c) Transient Non-Community Systems
3. Geographic Location
4. Likelihood of Finding Contaminants
5. State Plans for the Representative
Sample
(a) Representative State Plans
(b) Systems Selected for Pre-Screen Testing
(c) Tribal Water Systems
(d) "Index" Systems
(e) Other State Data
G. Reporting of Monitoring Results
1. Reporting Requirements (Data Elements)
2. Reporting to the Primacy Agency
3. Timing of Reporting
4. Method of Reporting
5. Public Notification of Availability of
Results
VH. Section-by-Section Analysis of Public
Comment and EPA Response
A. Section 141.35—Reporting of
Unregulated Contaminant Monitoring
Results
1. Does this reporting apply to me?
2. To whom must I report?
3. When do I report monitoring results?
4. What information must I report?
5. How must I report this information?
6. Can the laboratory to which I send
samples report the results for me?
7. Can I report previously collected data to
meet the testing and reporting
requirements for the contaminants in
§141.40(a)(3)?
B, § 141.40—Monitoring Requirements for
Unregulated Contaminants
1. Requirements for Owners and Operators
of Public Water Systems
(a) Do I have to monitor for unregulated
contaminants?
(b) How would I be selected for the
monitoring under the State Monitoring
Plan, the screening survey, or the pre-
screen testing?
(c) For which contaminants must I
monitor?
(d) What general monitoring requirements
must I follow for List 1 monitoring?
(e) What specific sampling and quality
control requirements must I follow for
monitoring of List 1 contaminants?
(i) All systems
(ii) Large systems
(A) Timeframe
(B) Frequency
(C) Location
(D) Sampling instructions
(E) Testing and analytical methods
(F) Sampling deviations
(G) Testing
(iii) Small systems that are part of the State
• Monitoring Plan
(A) Frequency
(B) Location
(C) Sampling deviations
(D) Sample kits
(E) Sampling instructions
(F) Duplicate samples
(G) Sampling forms
(H) Sample submission
(f) What additional requirements must I
follow if my system is selected as an
Index system?
(g) What must I do if my system is selected
for the Screening Survey or Pre-Screen .
Testing?
(h) What is a violation of this rule?
2. Requirements for State and Tribal
Participation
(a) How can I as the director of a State or
Tribal drinking water program
participate in unregulated contaminant
monitoring, including the State
Monitoring Plan for small systems, and
the Screening Survey and Pre-Screen
Testing of all systems?
(b) What if I decide not to enter into an
MOA?
(c) Can I add contaminants to the
Unregulated Contaminant Monitoring
List?
(d) Can I waive monitoring requirements?
C. Appendix A—Quality Control
Requirements for Testing All Samples
Collected
D. § 142.15—Reports by States
E. § 142.16—Special primacy requirements
VIII. General Issues From Public Comment
and EPA Response
A. Data Quality
B. EPA Funding for Small System Testing
C. Lab Certification
D. Research
E. Regulation Format
F. Voluntary Data Submittal
IX. Other Changes Related to the Regulation
A. Implementation of the Rule
1. Setting an Effective Date.
2. Analytical Methods for the Testing
Program.
3. Testing Program for Large Systems.
4. Testing Program for Small Systems.
5. Continued Development of Analytical
•Methods.
6. Determining the Representative National
Sample and State Monitoring Plans.
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50558 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
7. Specifying the Vulnerable Monitoring
Period.
8. Conducting the Sampling.
9. Establishing Sampling Points.
10. Large Systems.
11. Systems in State Monitoring Plans.
12. Screening Survey.
13. Pje-Screen Testing.
14. testing.
15. Reporting Requirements.
16, Record Keeping.
17. Previously Collected Data.
18. Modifying the Monitoring List.
B. Implementation in Indian Country
C. Performance-based Measurement
System
X. Guidance Manuals
XI Costs and Benefits of the Rule
A. Program Cost Estimates
1. Assumptions: Assessment Monitoring
2. Estimated Average Annual Cost for 5-
Year Program: Assessment Monitoring
Only
B. Estimated Net Costs
C, Benefits
Xfl. Administrative Requirements
A. Executive Order 12866—Regulatory
Planning and Review
B. Executive Order 13045—Protection of
Children From Environmental Health
Risks and Safety Risks
C. Unfunded Mandates Reform Act
D. Paperwork Reduction Act
E. Regulatory Flexibility Act
1. Full Assessment Monitoring
Implementation Scenario
2. Limited Implementation Scenario
F. National Technology Transfer and
Advancement Act
G. Executive Order 12898—Federal
Actions to Address Environmental
Justice in Minority Populations and Low-
Income Populations
H. Federalism Executive Orders
I. Executive Order 13084—Consultation
and Coordination with Indian Tribal
Governments
J. Congressional Review Act
Xin. Public Involvement in Regulation
Development
XIV. References
Potentially Regulated Entities
The regulated entities are public
water systems. All large community and
non-transient non-community water
systems serving more than 10,000
persons are required to monitor. A
community water system (CWS) means
a public water system 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
(NTNCWS) means a public water system
that is not a community water system
and that regularly serves at least 25 of
the same persons over 6 months per
year. Only a national representative
sample of community and non-transient
non-community systems serving 10,000
or fewer persons would be required to
monitor. Transient non-community
systems (i.e., systems that do not
regularly serve at least 25 of the same
persons over six months per year)
would not be required to monitor.
States, Territories, and Tribes, with
primacy to administer the regulatory
program for public water systems under
the Safe Drinking Water Act sometimes
conduct analyses to measure for
contaminants in water samples and are
regulated by this action. Categories and
entities potentially regulated by this
action include the following:
Category
Examples of potentially regulated entities
SIC
State, Territorial and Tribal Governments
Industry
Municipalities.
States, Territories, and Tribes that analyze water samples on behalf of public water
systems required to conduct such analysis; States, Territories, and Tribes that
themselves operate community and non-transient non-community water systems
required to monitor.
Private operators of community and non-transient non-community water systems re-
quired to monitor.
Municipal operators of community and non-transient non-community water systems
required to monitor.
9511
4941
9511
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
regulated by this action. This table lists
the types of entities that EPA is now
aware of that could potentially be
regulated by this action. Other types of
entities not listed in the table could also
be regulated. 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.
I. Statutory Authority
SDWA section 1445 (a) (2). as amended
In 1996, requires EPA to establish
criteria for a program to monitor
unregulated contaminants and to
publish, by August 6,1999, a list of
contaminants to be monitored. To meet
these requirements, today's rule EPA
substantially revises the existing
Unregulated Contaminant Monitoring
(UCM) Program, which is codified at 40
CFR 141.40. This final rule revises the
regulations at 40 CFR 9.1, 141.35.
141,40,142.16 and deletes and reserves
142.15(c)(3). The rule covers: (1) the
frequency and schedule for monitoring,
based on PWS size, water source, and
likelihood of finding contaminants; (2) a
new, shorter list of contaminants for
which systems will monitor; (3)
procedures for selecting and monitoring
a nationally representative sample of
small PWSs (those serving 10,000 or
fewer persons), and; (4) procedures for
entering the monitoring data in the
National Drinking Water Contaminant
Occurrence DataBase (NCOD), as
required under section 1445.
EL Major Program Revisions
Since its inception in 1988, the UCM
Program has collected occurrence data
to help EPA determine which
contaminants EPA should regulate
based on contaminant concentrations in
PWSs and the contaminants' adverse
health effects levels. Today's rule is
designed to improve and enhance this
program in several important ways:
(1) A statistical approach to select
only 800 representative systems for
monitoring from the national total of
65,600 small systems reduces the
monitoring burden of the water supply
industry; the burden on small systems is
significantly further reduced in that
EPA will pay for virtually all of the
costs associated with monitoring for the
small systems that are part of the
representative sample;
(2) A smaller number of contaminants
to be monitored also reduces the testing
and reporting burden of the water
industry overall;
(3) The required information to be
reported about each contaminant has
been refined to improve the data quality
for regulatory decisions; and
(4) Direct reporting of data for
regulatory determination and
development from systems to EPA
reduces State reporting burden, and the
opportunity for electronic reporting
reduces the potential for data entry and
submission.
A three-tier monitoring approach
allows monitoring to start promptly for
contaminants with approved analytical
methods, while accommodating the
need to delay implementation for
contaminants needing further methods
development. The rule also allows use
of a State-EP A Memorandum of
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Federal Register/Vol. 64. No. ISO/Friday, September 17, 1999/Rules and Regulations 50559
Agreement, providing direct
implementation in each State rather
than implementation through primacy
revisions, to address the three-tiered
approach of the UCMR.
This program is a cornerstone of the
"sound science" approach to future
drinking water regulations, which is a
goal of the 1996 SDWA Amendments.
Data generated by this final rule will be
used to: (1) evaluate and prioritize
contaminants on the Contaminant
Candidate List (CCL) and refine the
CCL; (2) support the Administrator's
determination of whether to regulate a
contaminant under the drinking water
program; and, (3) support the
development of drinking water
regulations.
In a related, cost-savings action, EPA
published a Direct Final Rule (64 FR
1494) on January 8, 1999, suspending
the monitoring requirements in effect
for small systems serving 10,000 or
fewer persons. The third round of
monitoring by small systems under the
existing list of unregulated
contaminants would have overlapped
with the monitoring required under this
final rule. The Direct Final Rule saved
small systems and States the cost of
unnecessary monitoring. EPA believes it
obtained sufficient data from the
previous monitoring rounds to make
decisions concerning the occurrence of
the unregulated contaminants on its
prior monitoring list for these systems.
Large systems were not included in this
Direct Final Rule since they had already
begun the third round of monitoring in
January 1998. This large system
monitoring will provide confirming
information on the occurrence of those
contaminants. However, this final
regulation cancels further monitoring by
large systems for the existing list of
contaminants effective January 1, 2001.
Until that date, large systems must
continue to monitor for the 48
contaminants listed in 40 CFR 141.40
(and also listed in Table 1 of "Revisions
to the Unregulated Contaminant
Monitoring Regulation for Public Water
Systems," Federal Register, vol. 64, no.
83, April 30, 1999, p. 23401 (64 FR
23401)).
HI. Regulatory Background
The requirements for unregulated
contaminant monitoring were first
established by the 1986 SDWA
Amendments. Under this law, EPA
implemented the drinking water
standards in phases, with each phase
having a set of contaminants for which
maximum contaminant levels in
drinking water were established. The
phases also included unregulated
contaminants for which more
information was needed before
decisions could be made regarding
regulation of the contaminants. EPA
included unregulated contaminant
monitoring requirements in the Phase I
chemical regulation, under 40 CFR
141.40(a)-(e). The Phase H regulation
later superceded the Phase I rule, and
some of the Phase I unregulated •
contaminants became regulated under
Phase n. Additional contaminants were
also added to the list of unregulated
contaminants. The Phase V chemical
regulation further modified the list of
contaminants, as additional unregulated
contaminants became regulated.
The basic monitoring and reporting
requirements for unregulated
contaminants were the same under the
Phase I, Phase H, and Phase V
regulations. PWSs were required to
report their monitoring results to the
primacy agencies (either the State or
EPA), with States, in turn, reporting to
EPA. Only systems serving fewer than
150 service connections were exempt
from monitoring—provided they made
their facilities available for monitoring
by the States. Repeat monitoring was
required every 5 years.
Section 125 of the 1996 SDWA
Amendments substantially revised
unregulated contaminant monitoring
program. The new program includes: (1)
a new list of contaminants (i.e., the
Unregulated Contaminant Monitoring
Regulation (UCMR) (1999) List; (2) a
representative sample of PWSs serving
10,000 or fewer persons to monitor; (3)
placement of the monitoring data in the
NCOD, and; (4) notification of
consumers that the monitoring results
are available.
The 1996 amendments limit the
number of contaminants to be
monitored on the UCMR list to a
maximum of 30. The amendments
specify that only a representative
sample of small systems are required to
monitor, and that EPA must pay the
reasonable costs of analyzing the
samples taken by those systems. EPA
will use the data generated by this
monitoring effort in the development of
future drinking water regulations.
Today's final rul? will completely
replace the requirements of the existing
rule on the final rule's effective date of
January 1, 2001. The existing
requirements of 40 CFR 141.35 and
141.40 still apply to large systems
serving more than 10,000 persons,
(since their third round of monitoring
had begun in January 1998) until
January 1, 2001, as noted above in II.
Major Program Revisions.
IV. Process of Preparing the Final Rule
EPA has been developing the final
revisions to the Unregulated
Contaminant Monitoring Regulation
(UCMR) for public water systems since
1997. In December, 1997, EPA's UCMR
development workgroup held a
stakeholders meeting to obtain input
from the public on major issues and
options affecting the program and
emanating from the Safe Drinking Water
Act, as amended in 1996. EPA held a
second stakeholders meeting in May
1998, on options under serious
consideration for the UCMR. EPA
engaged eleven external expert
reviewers from March 1 through April
22, 1999 to examine and comment on
the technical aspects of the proposed
rule. These technical reviewers
evaluated and commented on the
chemical and microbiological
contaminant analytical methods and
reporting requirements, the statistical
approach for the representative sample
of small systems, and the sampling and
monitoring approach. The comments of
the technical reviewers were available
to the public through the official docket
and on the Internet through EPA's
Office of Ground Water and Drinking
Water electronic homepage.
EPA published the proposed rule in
the Federal Register on April 30. 1999,
for public comment. The comment
period closed on June 14, with
submissions from 39 commenters
meeting the deadline and addressing all
major aspects of the proposed
regulation. EPA received one hundred
sixteen comments after the public
comment period closed, principally
concerning the inclusion of perchlorate
on the UCMR monitoring list. EPA
considered and addressed all comments
in the process of developing this final
regulation.
V. Concise Description of Today's
Action
A. Which Systems Must Monitor
Owners and operators of community
and non-transient noncommunify water
systems must monitor for unregulated
contaminants if they serve more than
10,000 persons or if they are part of the
representative sample of small systems
serving 10,000 or fewer persons that
will be randomly selected to monitor for
these contaminants. Transient systems
are not required to monitor for
unregulated contaminants. Only
purchased water systems that are
identified by EPA or the State to sample
at locations of low disinfectant residual
or longest residence time are required to
monitor for distribution system
contaminants.
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50560 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
i; I!
B. System Monitoring Requirements
The contaminants included in this
action are: 2,4-dinitrotpluene, 2,6-
dinitrotoluene, DCPA mono acid
degradate, DCPA di acid degradate, 4,4'-
DDE, EPTC, molinate, MTBE,
nitrobenzene, terbacil, acetochlor, and
perchlorate. Systems must also analyze
for water quality parameters including,
for chemical contaminants: pH; and for
microbiological contaminants: pH,
temperature, turbidity, free disinfectant
residual and total disinfectant residual.
Surface water systems must monitor
during four consecutive quarters.
Ground water systems must monitor
two times five to seven months apart.
One sampling event for surface and
ground water systems must be during
the vulnerable time of May 1 to July 31,
or during an alternate vulnerable time
selected by the State. Monitoring must
be conducted at the entry point to the
distribution system, or at other sampling
locations previously specified by the
State for compliance monitoring, for
sampling points representative of each
principal, non-emergency water source
in use over the one year of monitoring.
Large and small systems must monitor
according to the quality control
procedures described. Laboratories that
are certified to use the indicated
methods for the contaminants listed are
automatically certified to analyze for
unregulated contaminants. Small
systems that are part of the
representative sample which become
part of State Monitoring Plans must
follow instructions given them for
unregulated contaminant sampling and
shipment to the designated laboratory.
C. System Reporting Requirements
After testing for the contaminants on
the monitoring list, the systems must
report the results electronically to, or in
an alternate format previously arranged
With, EPA within 30 days following the
month they receive the results. EPA will
.report the results for the small systems
that are selected to be part of the State
Monitoring Plans. EPA will hold the
data for 60 days to allow for quality
control review by systems and States
before placing the data in the National
Drinking Water Contaminant
Occurrence Database.
Data required to be reported include:
Public Water System (PWS)
Identification Number; Sample
Identification Number; Sample
Collection Date; Contaminant/
parameter, Analytical Results—Sign;
Analytical Result—Value; Analytical
Result—Unit of Measure; Analytical
Method Number; Public Water System
Facility Identification Number—Source,
Treatment Plant and Sampling Point;
Sample Analysis Type; Detection Level;
Detection Level Unit of Measure; Batch
Identification Number; Spiking
Concentration; Analytical Precision;
Analytical Accuracy; Presence/Absence.
A system can have a laboratory report
the results for it, but the system retains
the responsibility for reporting. A
system can report previously collected
data as long as the data meet the
requirements specified in 40 CFR
141.40(a) (3), (4), (5) and Appendix A
and include the applicable water quality
parameters and data listed previously
that are required to be reported.
D. State and Tribal Participation
States and Tribes can enter into a
Memorandum of Agreement (MOA)
with the EPA concerning the
implementation of the monitoring
program. The MOA must address the
following: accepting or modifying the
State Monitoring Plan for small systems,
determining an alternate vulnerable
time, modifying the timing of
monitoring, identifying sampling points
for small systems, notifying small and
large systems of their monitoring
responsibilities, and providing
instructions to systems. A State can
remove a system from the State
Monitoring Plan, after EPA review, as
long as removal is not based on prior
information on the occurrence or non-
occurrence of contaminants at the
system or the vulnerability of the system
to the contaminants. States can decide •
not to participate in an MOA, in which
case the EPA will establish a State
Monitoring Plan. The governors of seven
or more States can petition EPA to add
contaminants to the monitoring list.
States can apply to EPA to waive
monitoring for large systems if they can
demonstrate that the contaminants for
which a monitoring waiver is sought
have not occurred in the State in the
past 15 years.
VI. Final Changes in the Unregulated
Contaminant Monitoring Program
A. Revised List of Unregulated
Contaminants To Be Monitored
1. Criteria for Selecting Contaminants
fortheUCMR
(a) Revising the UCMR (1999) List
Section 1445(a)(2)(B) requires EPA to
list not more than 30 unregulated
contaminants to be monitored by public
water systems. EPA used the 1998
Contaminant Candidate List (CCL),
established under section 1412(b)(l)(B)
of SDWA, as the primary basis for
selecting contaminants for future
monitoring under the UCMR.
/• •• ":, I •' . i •'• „" / ' ::• i
Development of the CCL is discussed in
the preamble to the proposed rule at 64
FR 23402. EPA believes, and nearly all
public commenters addressing the use
of the CCL as the basis for the UCMR
List indicated, that the CCL process
already uses the best available
information on contaminants of concern
and emerging contaminants that may
need regulation. SDWA section 1445
(a) (2) (B) (ii) provides for the governors of
seven or more States to petition the
Agency to add contaminants to the
UCMR List. This petition process allows
for the flexibility to include
contaminants that are emerging as
concerns between the five-year listing
cycles.
The CCL lists 26 chemical and 8
microbiological contaminants as
occurrence priorities because additional
data on their occurrence in drinking
water are needed to help decide
whether they should be regulated. The
proposed rule did not address the two
contaminants identified in the
preparation of the CCL as highly
localized in occurrence: perchlorate and
RDX (hexahydro-l,3,5-trinitro-l,3,5-
triazine). EPA now has information
indicating that the occurrence of these
contaminants is more widespread than
. originally thought. In response to this
information, some of which was
provided in public comments, EPA has
added perchlorate and RDX to the final
UCMR (1999) List. Perchlorate was
added to the UCMR (1999) List because
EPA feels that there is enough
information on its occurrence in public
water systems to warrant its inclusion in
a national monitoring program. Since it
was not included on the proposed
UCMR (1999) List, EPA did not take
comment on its analytical method,
minimum reporting level, or sampling
location. EPA is currently engaged in
final validation of an analytical method
for perchlorate. This validation is
important because earlier analytical
methods did not make adjustments for
interferences from sulfate and chloride,
thus reducing or eliminating detected
concentrations. EPA feels that with this
validation, the analytical method should
be sufficiently ready for monitoring, and
thus EPA has included perchlorate on
the UCMR List 1. EPA plans to publish,
for public comment, the analytical
method, minimum reporting level, and
sampling location for perchlorate
shortly after the promulgation of this
final rule. RDX now appears on UCMR
(1999) List 2, indicating that additional
information is available, and initial
monitoring of occurrence in public
water systems should occur but that its
method needs further refinement.
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Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations 50501
Additionally, based on technical peer
review and public comments, EPA
moved Aeromonas from UCMR (1999)
List 1 to UCMR (1999) List 2 in Table
1, because its analytical method is not
expected to be validated until 2000 or
2001. Also, in response to public
comments that the Agency include as
many contaminants that could be tested
under the same multi-analyte method as
possible in Assessment Monitoring, EPA
moved acetochlor to List 1 from List 2.
This action is based on information that
only minor refinements are needed in
the method and those can be resolved
before the effective date of today's rule.
As a result, the analytical method is
reserved until the details of the method
are resolved. EPA plans to publish a
revision to this final rule to approve an
analytical method for acetochlor shortly
after this rule's promulgation. EPA will
likely publish a joint request for public
comment on the analytical methods for
perchlorate and acetochlor. EPA intends
to approve and publish the methods as
early as possible to allow monitoring to
begin on January 1, 2001, and to allow
for the reporting of any data obtained
prior to January 1, 2001 to meet the
requirements of this final Rule.
For the remaining contaminants on
the CCL Occurrence Priorities List, EPA
has evaluated the availability of
analytical methods published by EPA or
voluntary consensus standards
organizations, such as the American
Society for Testing and Materials
(ASTM) and Standard Methods (SM). In
addition, EPA prioritized analytical
methods development activities for
those compounds and microorganisms
for which suitable analytical methods
are not currently available. As listed in
List 1 of Table 1, EPA identified 10 of
the 12 listed chemical contaminants for
which analytical methods are now
available. UCMR (1999) List 1
contaminants are those for which
monitoring is required under today's
Rule, with the added note that
analytical methods have yet to be
approved for perchlorate and
acetochlor. UCMR (1999) List 2 of Table
1 lists 16 contaminants for which
analytical methods are being refined: 14
chemical contaminants, Aeromonas (a
microorganism), and polonium-210
(discussed in Table 1). UCMR (1999)
List 3 of Table 1 identifies seven
microbiological contaminants and lead-
210 for which analytical methods are
being researched. Monitoring for
contaminants on UCMR (1999) Lists 2
and 3 is not required until EPA
promulgates revisions to this rule to
specify analytical methods and related
sampling requirements for them.
EPA requested comment on the
addition to the UCMR (1999) List of two
naturally occurring radionuclides with
health concerns at low levels, lead-210
(pb-210), and polonium-210 (po-210).
Both nuclides are in the uranium decay
series, which also includes radium-226
and radon-222, Lead-210, with a half-
life of 22 years, and one of its
degradates, polonium-210, with a half-
life of 138 days, have been found in
drinking water. EPA is aware of the
occurrence of these contaminants in
shallow aquifers in Florida (Harada, et
al., 1989; Upchurch, 1991), and in at
least two other States. Because of
potential occurrence, consequent health
risks, and in response to public
comments, EPA has added polonium-
210 and lead-210 to the UCMR (1999)
List and has placed them on Lists 2 and
3 respectively.
(b) Regulatory Approach for the UCMR
(1999) List
EPA establishes in § 141.40(a)(3) that
the contaminants listed in Lists 1-3
comprise the UCMR (1999) List,
categorized based on the availability of
analytical methods. UCMR (1999) List 1
is the basis for Assessment Monitoring.
Assessment Monitoring will occur at all
2,774 large community and non-
transient non-community public water
systems serving more than 10,000
persons and at a representative sample
of approximately 800 systems serving
10,000 or fewer persons identified in
State Monitoring Plans. UCMR (1999)
List 2 will be the basis for two Screening
Surveys of approximately 300 systems
each, statistically selected from those
systems required to conduct Assessment
Monitoring. UCMR (1999) List 3 will be
used for Pre-Screen Testing at up to 200
systems selected because of their
potential vulnerability to the specific
contaminants. This monitoring
approach is described in detail under
Section VI.C, "Type of Monitoring
Required of Public Water Systems Based
on Listing Group." Assessment
Monitoring (and associated "Index
system" monitoring) is the only
monitoring that would be required by
today's action. This includes
contaminants for which EPA expects to
have developed analytical methods
before implementation: perchlorate and
acetochlor.
For contaminants on UCMR (1999)
List 2 for which analytical methods are
developed by the time of initial
monitoring in 2001, EPA will amend
this rule to require the first Screening
Survey to be conducted at selected
systems. For those contaminants on List
2 and List 3 that do not have well
developed methods by the time of initial
monitoring in 2001, EPA will issue a
revision to this regulation to activate
monitoring for them at the time when
the methods are considered
implementable, up to the limit of 30
contaminants to be monitored within
the five-year contaminant listing cycle.
Monitoring for those contaminants will
then begin at a date specified in that
prospective regulation. Therefore,
monitoring of contaminants on UCMR
(1999) Lists 2 and 3 is not required by
today's action! Monitoring of these
contaminants will only occur when EPA
publishes a revision to this regulation
specifying the analytical methods to be
used and the period during which
monitoring is to be completed.
(c) Analytical Methods Applicable to
the UCMR (1999) List
The UCMR (1999) List development
process focuses primarily on the
availability of analytical methods for the
listed contaminants and the level of
information available for them at the
time of its development. The discussion
below highlights analytical method
considerations in listing the
contaminants for monitoring. Only the
contaminants identified on UCMR
(1999) List 1, will be monitored as a
result of today's action, with the
exceptions of perchlorate and
acetochlor, for which analytical
methods have yet to be approved.
Contaminants on UCMR (1999) Lists 2
and 3 are included on the final UCMR
(1999) List, but will not be activated for
monitoring until EPA proposes and
promulgates analytical methods that can
be used to reliably measure their
occurrence in drinking water. At that
time, EPA will propose regulations for
the monitoring of UCMR (1999) List 2
and 3 contaminants.
(i) Chemical Analytical Methods
The ability to correctly identify a
chemical contaminant is directly related
to the type of chemical and the
analytical method used. Compounds
such as disinfection byproducts are far
less likely to be misidentified than
pesticides because they are typically
present at relatively high concentrations
in disinfected waters, while pesticides
are much less likely to occur, or occur
at lower concentrations. The analytical
method selected will determine the
accuracy of the qualitative
identification. In general, the most
reliable qualitative identifications will
come from methods that use mass
spectral data for contaminant
identification. However, these methods
are typically less sensitive than methods
that rely on less selective detectors.
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50562 Federal Register/Vol. 64, No. ISO/Friday. September 17, 1999/Rules and Regulations
Before EPA establishes a Maximum
Contaminant Level (MCL), the Agency
relies on an analytical method suitable
for routine monitoring. It is likely that
analytical methods in general use by
laboratories performing drinking water
analyses may not exist for some of the
final compounds to be measured in the
UCMR program. Complex analytical
methods or methods requiring special
handling often require more
experienced laboratories than the
laboratories performing routine
Compliance monitoring. Even when
analytical methods that are in general
use by analytical laboratories are
available, limiting the analyses to a
small number of laboratories operating
under strict quality control
requirements improves the precision
and accuracy of the analyses, thereby
Increasing the usefulness of the data.
The option favored by many
stakeholders for conducting the
chemical laboratory analyses and made
final today by EPA is the following:
For PWSs serving more than 10,000
people, the PWS is responsible for
sample collection and analyses for
Assessment Monitoring. This
monitoring may be conducted at the
,1
same time as the required compliance
monitoring, to the extent possible. For
Assessment Monitoring, however, EPA
requires in § 141.40(a)(3) and § 141.40
Appendix A, quality control procedures
for both sampling and testing to ensure
that the data collected under this
regulation are of sufficient quality to
meet the requirements of the related
regulatory decisions. Thus, today's
action specifies the analytical methods
and procedures to be used in obtaining
these data. The sampling and associated
quality control requirements cover time
frame, frequency, sample collection and
submission, and review and reporting of
results. The laboratory analytical quality
control requirements address the use of
a certified laboratory, sample collection/
preservation, analytical methods,
method detection limits, calibration,
quality control samples, method
performance tests, detection
confirmation, and reporting. PWSs
serving 10,000 or fewer persons must
send their Assessment Monitoring
samples to laboratories designated by
EPA, since the Agency must pay for the
reasonable costs of testing.
The purpose of the quality control
requirements is to ensure that, since
EPA will only be able to obtain results
from 3,574 systems (2,774 large systems
and a representative sample of 800
systems from 65,600 systems serving
10,000 or fewer persons), the Agency
obtains the most reliable data possible.
EPA is specifying the use of certain
analytical methods that are currently
available for monitoring (see Table 3,
UCMR (1999) List, column 3). While
these methods are routinely used by
commercial and public water system
laboratories (including some that are
currently used for compliance
monitoring), they have not been
routinely used for the contaminants on
the UCMR (1999) List. Note that, as
shown in § 141.40(a)(3), Table 1,
methods other than those that EPA has
developed may be approved for use, but
quality control procedures must also be
followed, as specified in § 141.40(a)(3),
(4) and (5), and Appendix A.
For the compounds included in this
regulation, the following summary,
Table 1, Status of Analytical Methods
for Chemical Contaminants on the
UCMR (1999) List, presents a brief
overview of methods availability for
each chemical contaminant.
II
TABLE i.—STATUS OF ANALYTICAL METHODS FOR CHEMICAL CONTAMINANTS ON THE UCMR (1999) LIST
CAS No.
Analytical methods
Status of availability
UCMR (1999) List 1—Chemical Contaminant
i""
2,4-dinitrotoluone
2,6-o'WtrotoIuene
4.4'-DDE
Aostochlor !
DCPA dj acid degradate
DCPA mono acid degradate ...
, I
EPTC
Molinats
MTBE
" ' ' ""
Nitrobenzena
PH. :
"
121 14-2
606-20-2
72-55-9
34256-82-1
2136-79-0
887-54-7
759-94-4
2212-67-1
1634-04-4
98-95-3
EPA 525 2 ..
EPA 525.2
EPA 508
EPA 508.1
EPA 525.2
D5812-96
AOAC 990.06
In validation process
EPA 515.1
EPA 515.2
D5317-93
AOAC 992.32
EPA 515.1
EPA 515.2
D5317-93
AOAC 992.32
EPA 507
EPA 525.2
D5475-93
AOAC 991.07
EPA 507
EPA 525.2
D5475-93
AOAC 991.07
EPA 524.2
D5790-95
SM621 OD
SM6200B
EPA 524.2
D5790-95
SM621 OD
SM6200B
Method is adequate for monitoring
Method is adequate for monitoring
Methods are adequate for monitoring
EPA anticipates that this compound can be a
scope of EPA Method 525.2.
No method is available to measure the mono
forms separately All of the approved methods
mono and di acid forms
No method is available to measure the mono
forms separately. All of the approved methods
mono and di acid forms
Methods are adequate for monitoring
Methods are adequate for monitoring
Methods are adequate for monitoring
Methods are adequate for monitoring
dded to the
and di acid
identify total
and di acid
identify total
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Federal Register/Vol. 64. No. ISO/Friday. September 17, 1999/Rules and Regulations 5O5G3
TABLE 1.—STATUS OF ANALYTICAL METHODS FOR CHEMICAL CONTAMINANTS ON THE UCMR (1999) LIST—Continued
Perchlorate
Terbaoil
UCMR (1999) List 2—
Chemical Contaminant
1 ,2-diphenylhydrazine
2,4,6-trichlorophenol
2,4-dichlorophenol
2,4-dinitrophenol
2-methylphenol
Alachlor ESA and degradation
byproducts of acetaniiide
pesticides.
Diazinon .-.
Disulfoton
Diuron
Fonofos ::;....
Linuron
PoIonium-210 (2">pO)
CAS No.
14797-73-0
5902-51-2
122-66-7
88-06-2
120-83-2
51-28-5
95-^8-7
333-41-5
298-04-4
330-54-1
944-22-9
330-55-2
13981-52-7
Analytical methods
In validation process
EPA 507
EPA 525.2
D5475-93
AOAC 991.07
In development
In development
In development .
In development
In development
To be determined
In development
In development
In development
In development
In development
In development
Status of availability
EPA is currently conducting analytical methods development
to support the analyses of perchlorate. This new method
will be based on the currently available ion chroma-
tography methods, but will include a criteria detailing when
a laboratory must perform a sample clean-up procedure to
minimize the impact of elevated concentrations of chloride,
sulfate or other dissolved solids.
Methods are adequate for monitoring.
Some methods evaluated but inadequate for monitoring. Pri-
ority for analytical method development. EPA anticipates
that contaminant will be added to the scope of EPA Meth-
od 525.2.
EPA Method 552 evaluated but subject to false positives
from interferences of the derivitized byproduct of the con-
taminant. EPA anticipates that contaminant will be included
in a new SPE/GC/MS method currently under develop-
ment.
EPA Method 552 evaluated but subject to quantitative uncer-
tainty due to inadequate derivatizat'on of the contaminant.
EPA anticipates that contaminant will be included in a new
SPE/GC/MS method currently under development.
Some methods evaluated but inadequate for monitoring. EPA
anticipates that contaminant will be included in a new SPE/
GC/MS method currently under development.
Some methods evaluated but inadequate for monitoring. EPA
anticipates that contaminant will be included in a new SPE/
GC/MS method currently under development.
EPA is evaluating which specific contaminants will be in-
cluded within this group of compounds. Analytical methods
will be determined for the targeted contaminants.
Diazinon is listed as a contaminant in several EPA and vol-
untary consensus standard organization methods but it is
subject to rapid aqueous degradation. Preservation re-
search currently being conducted to develop a preserva-
tion technique that would permit adding this compound to
EPA Method 525.2.
Disulfoton is listed as a contaminant in several EPA and vol-
untary consensus standard organization methods but it is
subject to rapid aqueous degradation. Preservation re-
search currently being conducted to develop a preserva-
tion technique that would permit adding this compound to
EPA Method 525.2.
While this compound is included in the scope of NPS Method
4 (LLE/HLPC/UV) and EPA Method 553 (SPE/HPLC/MS),
these methods are not adequate for this monitoring. EPA
anticipates that this compound can be included in a new
SPE/HPLC/UV method currently being developed.
Fonofos is listed as a contaminant in several EPA and vol-
untary consensus standard organization methods but it is
subject to rapid aqueous .degradation. Preservation re-
search is currently being conducted to develop a preserva-
tion technique that would permit adding this compound to
EPA Method 525.2.
While this compound is included in the scope of NPS Method
4 (LLE/HLPC/UV) and EPA Method 553 (SPE/HPLC/MS),
these methods are not adequate for this monitoring. EPA
anticipates that this compound can be included in a new
SPE/HPLC/UV method currently being developed.
Radiochemistrv laboratorv cansoitv is limited
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50564 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
.
TABLE 1.—STATUS OF ANALYTICAL METHODS FOR CHEMICAL CONTAMINANTS ON THE UCMR (1999) LIST—Continued
CAS No.
Analytical methods
Status of availability
prometon
1610-18-0
In development
RDX
Terbufos
121-82-4
13071-79-9
In development
In development
UCMR (1999) List 3—
Chemical Contaminant
Lead-2f 6 (iiopb) .1
14255-04-0
In development
Prometon is listed as a contaminant in several EPA and vol-
untary consensus standard organization methods but it is
subject to rapid aqueous degradation in non-acidified sam-
ples and is not readily extracted in acidified samples. Pres-
ervation research is currently being conducted to add neu-
tralizing the pH of acidified samples just prior to extraction.
This would permit adding this compound to EPA Method
525.2.
No EPA or consensus methods organization analytical meth-
ods for the analysis of RDX in water are currently avail-
able.
Terbufos is listed as a contaminant in several EPA and vol-
untary consensus standard organization methods but it is
subject to rapid aqueous degradation. Preservation re-
search is currently being conducted to develop a preserva-
tion technique that would permit adding this compound to
EPA Method 525.2.
Method is time-consuming and expensive. Radiochemistry
laboratory capacity is limited.
(il) Microbiological Analytical Methods
The discussion of data quality for
chemical analytical methods also
applies to microbiological testing when
analytical methods are developed for
CCL microorganisms. When
microorganisms were proposed for the
CCL, ElPA recognized that analytical
methods were not well developed for
the majority of them. Because of the lack
of available analytical methods, some of
the CCL microorganisms were grouped
either into one category wnere
information was available about
methodologies indicating a need to
further refine them, or another category
where more research, including research
on detection methods and occurrence,
Was needed. At the present time, and
based on technical peer review and
public comment, Aeromonas is the only
one of the microorganisms for which
more occurrence data are needed that
also has an analytical method likely to
be sufficiendy developed for monitoring
in time for implementation of the
Screening Surveys. Three other
microorganisms have methods available,
but are in need of further methods
development. These microorganisms
(Cyanobacteria, Echoviruses, and
Coxsackieviruses) may be candidates for
the Screening Surveys if methods
development proceeds expeditiously
(§ 141.40(a)(3), Table 1, List 2), but are
currendy identified for Pre-Screen
Testing (Table 1, List 3). The remaining
four microorganisms currently lack
satisfactory methods and will be
evaluated for Pre-Screen Testing.
Several microorganisms on the CCL
are actually groups of microorganism
taxa. In some cases, the taxa have so
many members that, given the limited
resources available for UCMR
monitoring, EPA may have to prioritize
which strains, species, or serotypes are
the most important to consider and
target those for monitoring or further
study. Decisions will have to be made
on the basis of health risk, disinfection
resistance, occurrence in water, and
other factors. To address the need to
prioritize which microorganisms should
be targeted for monitoring, EPA's Office
of Research and Development is
assisting the Office of Ground Water and
Drinking Water in establishing a
research program for health effects,
treatment, and analytical methods.
T4BLE 2.—STATUS OF ANALYTICAL METHODS FOR MICROBIOLOGICAL CONTAMINANTS ON THE UCMR (1999) LIST
Availability of analytical method
Status of availability
Ust 2—Microbiological Contaminant
Aeromonas
Ust 3—Microbiological Contaminant
Cyanobacteria (blue-green algae,
olher freshwater algae and their
toxins).
Echoviruses
Analytical method likely to be
available for monitoring.
Methods available but not stand-
ardized.
Methods available but not stand-
ardized.
Current modification and evaluation of a published membrane filtra-
tion method (Havelaar et al., 1987) indicates that this method will
be suitable for the monitoring program.
Methods are available for counting Cyanobacteria but new, standard-
ized methods are needed for direct counts of targeted species with
filtration methods or a counting chamber. Standardized analytical
methods are also needed to detect the more important
cyanobacterial toxins.
Echoviruses can be cultured on BGM cells and detected by the ICR
method but require supplemental methods such as serological typ-
ing to distinguish echoviruses from other viruses. Cost of cell cul-
ture assays plus serotyping can be high. RT/PCR methods are
• subject to interferences and do not demonstrate infectivity. Com-
bined cell culture and PCR, which demonstrates infectivity, may be
considered.
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Federal Register/Vol. 64. No. 180/Friday, September 17, 1999/Rules and Regulations 50565
TABLE 2.—STATUS OF ANALYTICAL METHODS FOR MICROBIOLOGICAL CONTAMINANTS ON THE UCMR (1999) LIST—
Continued
Availability of analytical method
Status of availability
Coxsackieviruses
Methods available but not stand-
ardized.
Helicobacter pylori.
No suitable method currently
available.
Microsporidia
No suitable method currently
available.
Adenovi ruses
Caliciviruses.
No suitable method currently
available.
No suitable method currently
available.
Group B Coxsackieviruses are easy to grow in tissue culture but
group A coxsackievirus detection in cell culture is variable.
Culturable Coxsackieviruses can be detected with the ICR method
but serological typing is needed to distinguish Coxsackieviruses
from other viruses. RT/PCR methods are subject to interferences
and do not demonstrate infectivity. New, standardized methods are
needed. Combined cell culture and PCR methods may be consid-
ered.
Helicobacter pylon;\s difficult to cultivate because of its slow growth
rate and the need for a low oxygen environment. No selective me-
dium exists that will discriminate H. pylori from background bac-
teria. A culture-based method that demonstrates viability is pre-
ferred. Methods are needed for selective growth and identification.
IMS has been used to concentrate Helicobacter pylori. Methods
using PCR alone have been used but have not been validated by
EPA. In general, PCR methods are not preferred due to inter-
ferences and their inability to demonstrate viability. A combined
cultural and molecular method may be considered.
No methods are available for the monitoring of the two species of
human microsporidia which may have a waterborne route of trans-
mission [Enterocytpzoon bienuesi and Encephalitozoon (formerly
Septata) intestinali^. Spores could possibly be detected by meth-
ods similar to those being developed for Cryptosporidium parvum.
Potential methods may utilize water filtration, clean-up with IMS,
and detection using microscopy with either fluorescent antibody or
gene probe procedures. Provided that procedures are validated by
EPA, reverse-transcriptase (RT)—PCR techniques may be consid-
ered for monitoring, although PCR methods in general are not pre-
ferred at this time due to interferences and their inability to dem-
onstrate viability. Due to the small size of microsporidia, problems
could be encountered during filtration.
Adenoviruses serotypes 1 to 39 and 42 to 47 can be grown in tissue
culture but enteric adenoviruses 40 to 41 are difficult to grow. Sev-
eral selective tissue culture methods and detection methods have
been reported. A selective, standardized method is needed for
monitoring. PCR methods are not preferred, as they are subject to
interferences and do not demonstrate infectivity. A combined cell
culture and PCR method may be considered.
No tissue culture methods exist for the two genogroups of
caliciviruses on the CCL (the Norwalk-like and the Snow Mountain-
like agents). No sensitive or fully developed detection methods
exist. PCR methods are not preferred, as they are subject to inter-
ferences and do not demonstrate infectivity. A combined cell cul-
ture and PCR method may be considered if a suitable cell line is
found.
2. List of Contaminants To Be
Monitored
(a) Final UCMR (1999) List
Section 141.40 (a) (3) Table 1,
Unregulated Contaminant Monitoring
Regulation (1999) List, presents EPA's
list of unregulated contaminants for
monitoring under Section
1445(a)(2)(B)(i) of the 1996
Amendments for the first five-year
listing cycle. The monitoring program
for these contaminants is a three-tiered
approach based on the availability of
information about each contaminant
and the availability of analytical
methods for each contaminant. This
approach is described in Section C.,
Type of Monitoring Required of Public
Water Systems Based on Listing Group.
The final monitoring program divides
the listed unregulated contaminants into
three lists: List 1, for which Assessment
Monitoring will be required, List 2,
designated for the Screening Surveys;
and List 3, designated for Pre-Screen
Testing. Today's final regulation only
requires Assessment Monitoring for
UCMR (1999) List 1 contaminants
beginning on January 1, 2001, with the
exceptions of perchlorate and
acetochlor, for which analytical
methods have not yet been approved
(but are planned to have monitoring
begin on that date, also, after
rulemaking to specify their analytical
methods). The monitoring for
contaminants on Lists 2 and 3 will only
be required after EPA promulgates
further rules.
Technical peer review and public
comments strongly supported the three-
tier approach of the UCMR program. As
a result, EPA requires in today's action
Assessment Monitoring for the
contaminants on UCMR (1999) List 1,
because analytical methods for these
contaminants currently exist or will
shortly be validated. EPA will shortly
publish a request for public comment on
a revision to this final rule to implement
the analytical methods and other
sampling requirements for perchlorate
and acetochlor. Also, by future
rulemaking, EPA plans to implement
the Screening Survey (List 2) monitoring
in groups of contaminants, rather than
one contaminant at a time, to minimize
sampling and testing costs since some of
the contaminants may be tested by the
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50566 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
same method. EPA intends to take a
similar approach with the contaminants
on List 3. the Pre-Screen Testing. EPA
plans to require, through future
rulemaking, Pre-Screen Testing for
contaminants for which EPA determines
that new analytical methods can
measure their existence in locations
where they are most likely to be found.
All analytical methods for contaminants
on Lists 2 and 3 would be peer
reviewed, following EPA's policy for
peer review, before the Agency proposes
regulations which would require public
Water systems to monitor for them.
In § 141.40 (a) (3), Table 1, UCMR
(1999) List 1 contaminants, for
Assessment Monitoring, are chemical
contaminants for which analytical
methods capable of generating the
quantity and quality of data required
under the UCMR are currently available,
or expected to be available shortly after
today's final rule. Monitoring for these
contaminants is required under today's
final UCMR, with the exceptions of
perchlorate and acetochlor, as noted.
UCMR (1999) List 2 contaminants (14
organic chemicals, one radiochemical
and one microorganism), for the
Screening Surveys, are those for which
EPA is currently refining analytical
methods. Development of these methods
should be sufficient for Screening
Surveys to be conducted in the first
three years of the listing cycle, but may
occur in the later years of the cycle.
These contaminants are characterized in
today's final rule at § I41.40(a)(3), Table
1, Unregulated Contaminant Monitoring
Regulation (1999) List, List 2.
UCMR (1999) List 3 contaminants
(seven microbiological contaminants or
contaminant groups and one inorganic
chemical), for Pre-Screen Testing, are
those for which EPA has begun or
shortly will begin analytical methods
development, but completion of those
efforts is not expected prior to the
Assessment Monitoring required under
implementation of this regulation.
Instead, these contaminants will be
tested for in Pre-Screen Testing. These
contaminants are listed in today's final
rule at § 141.40(a)(3) as Table 1.
Unregulated Contaminant Monitoring
List, List 3.
Tables 3 and 4, in IV.A,l.(c),
Analytical Methods Applicable to the
UCMR (1999) List, present a summary of
the status of the methods for all the
Contaminants on this list.
EPA believes that th'is three-tiered
approach to the UCMR, which was
recommended by stakeholders, reflects a
balance between the implementability
of current analytical methods and the
need to obtain data in time frames that
are useful for responding to concerns
about the contaminants identified.
(b) Number of Contaminants on the
UCMR (1999) List
Thirty-six contaminants are on
today's final UCMR (1999) List. SDWA
Section 1445 (a)(2)(B)(i) states that in
August 1999 and every five years
thereafter "the Administrator shall issue
a list of * * * not more than 30
unregulated contaminants to be
monitored by public water systems and
to be included in the national drinking
water occurrence data base * * *" EPA
interprets this to mean that the UCMR
list may contain more than 30
contaminants, as long as monitoring is
not required for more than 30
contaminants during a five-year listing
cycle. Public comments were split on
whether the monitoring list should have
more than 30 contaminants. EPA
believes that maintaining a monitoring
list with more than 30 contaminants,
while requiring monitoring for no more
than 30, is responsive to public
concerns about contaminants in
drinking water. This interpretation and
approach also supports EPA's efforts to
respond to and encourage analytical
methods development for emerging
contaminants.
Any PWS may voluntarily submit
data to EPA, including data for
contaminants that a PWS may monitor
that are on the UCMR (1999) List of 36
contaminants, but that are not on the
final list of 30 contaminants actually
required for UCMR monitoring. EPA is
preparing a guidance document
specifying the procedures for future
voluntary submission of such data to the
National Drinking Water Contaminant
Occurrence Database (NCOD).
B. Public Water Systems Subject to the
UCMR
The monitoring in this final rule
focuses ultimately on determination of,
on a national basis, the occurrence or
likely occurrence of contaminants in
drinking water delivered by community
water systems (CWS) and non-transient
non-community water systems
(NTNCWS). For regulatory purposes,
public water systems are categorized as
"community water systems," or "non-
community water systems." Community
water systems (CWSs) are specifically
defined as "public water systems which
serve at least 15 service connections
used by year-round residents or
regularly serve at least 25 year-round
residents." (40 CFR 141.2) A "non-
community water system" means any
other public water system. Non-
community water systems include
nontranisent non-community water
systems (NTNCWSs) and transient non-
community water systems. Non-
community water systems are available
to serve the public, but are not used on
a year-round basis in most cases. Non-
transient systems regularly serve at least
25 of the same persons over six months
per year (e.g., schools). Transient
systems do not regularly serve at least
25 of the same persons over six months
per year. Additionally, some community
water systems purchase all or part of
their water supply from other water
systems. Purchased water systems may
be at the end of a distribution system
from the water system selling the water.
One of the factors considered in
establishing the UCMR program is the
number of persons served fay a system.
With respect to size, about 2,774 large
systems (each serving more than 10,000
persons) provide drinking water to
about 80 percent of the U.S. population
served by public water systems. Under
today's final regulation, all large
systems will be required to monitor the
unregulated contaminants specified in
§ 141.40(a)(3), List 1 of Table 1, UCMR
(1999) List, with the exception of
perchlorate and acetochlor for which
analytical methods have not been
promulgated. In response to public
comment on purchased water systems
representing the end of a distribution
system, purchased water systems are
also included in this monitoring
requirement for microbiological
contaminants that occur primarily in
distribution systems with maximum
residence times or low disinfectant
residuals which may allow
microorganisms that have human health
effects to survive and reproduce.
Section 1445 (a) (2) (A) requires that the
UCMR ensure that only a representative
sample of systems serving 10,000 or
fewer persons (small systems) monitor
for unregulated contaminants. Small
community water systems and small
non-transient, non-community water
systems total 65,636 systems. From this
total number of small systems, EPA will
select a national representative sample
of 800 small systems. EPA is excluding
transient non-community systems from
UCMR requirements. The variation in
the 97,000 transient systems would be
difficult to reflect in a national
representative sample and would be
very costly to monitor. Furthermore,
projecting contaminant exposure results
from such systems would be complex
and inconclusive because of the
transient nature of the population that
uses them. The results from the very
small community and non-transient
non-community systems (NTNCWS) can
be extrapolated to the transient non-
community systems. Public comments
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supported not including these systems
in the representative sample. One
commenter suggested that transient
systems be the subject of a special
survey since they may be a pathway of
exposure for a specific segment of the
population. At this time, EPA is not
planning any special surveys of
transient systems because they are such
a large and diffuse category and it is
difficult to compile and evaluate
population exposure information for
this category of water systems.
EPA will pay for the reasonable costs
of monitoring by the small systems
selected for the representative sample,
as long as the systems are part of a State
Monitoring Plan. The EPA will select
systems to monitor through the use of a
random number generator according to
a national representative sample
selection plan developed primarily on
the basis of population served by PWSs
in each State. This detailed selection
plan is necessary to ensure that the
sample is statistically valid and
representative of all small water systems
nationally. This plan is also necessary
because EPA typically has the least
information about these systems and
needs a consistent base of data for
regulation development. EPA will use a
national sample of approximately 800
systems serving 10,000 or fewer persons
which the EPA will statistically draw
from all small CWSs and NTNCWSs
nationally. Section F, "Representative
Sample of Systems Serving 10,000 or
Fewer Persons," provides the details of
the sample selection plan, including the
sample size. The number of systems
selected within each size category of
systems will be based on the proportion
of population served by that size
category. System selection will be
further allocated across water source
type and distributed across all states.
The State-based component of this
national representative sample, called a
State Monitoring Plan (or State Plan),
will include the list of systems
statistically selected for UCMR
monitoring. Other state responsibilities
will be defined in the Memorandum of
Agreement issued between the States
and EPA. The State can review, and
modify if necessary, the list of systems
in the State Plan. The resulting State
Plans will then be part of a national
sample framework, providing the
representative national sample requisite
to drawing national conclusions for
contaminant exposure.
To provide a more capable
understanding of contaminants and
conditions affecting small systems, and
to provide additional quality assurance,
EPA will randomly select up to 30 small
public water systems from the systems
in State Monitoring Plans as "Index"
systems. Index systems must monitor
every year during the five year UCMR
listing cycle. These systems will also be
required to report information on
system operating conditions (such as
water source, pumping rates, and
environmental setting). This
information will assist EPA in more
fully evaluating small system operations
and future regulations of small systems.
EPA will conduct the sampling and
testing for Index systems. At the time of
sampling, EPA will also gather other
system information to characterize the
environmental setting affecting the
system including precipitation, land
and water resource use, and
environmental factors (such as soil type
and geology).
Also, up to 150 additional small
systems might be selected for the Pre-
Screen Testing. The systems for the Pre-
Screen Testing will be selected on the
basis of their representativeness of
systems most vulnerable to the
particular UCMR (1999) List 3
contaminants for which methods have
been refined. The statistical selection of
the 800 systems for the national
representative sample may not include
the systems determined to be most
vulnerable to these contaminants,
hence; the States and EPA may need to
select additional systems for this
targeted testing.
External expert peer review and
public comments supported the
statistical approach described to select
small systems for the national
representative sample and State
Monitoring Plans.
C. Type of Monitoring Required of
Public Water Systems Based on Listing
Group
At the UCMR Stakeholders Meeting
on June 3-4, 1998, a diverse group of
stakeholders suggested that the UCMR
Program be developed through a
progression of monitoring levels based
on contaminant group characteristics.
These characteristics reflect current
information about both the occurrence
of and method availability for the
contaminants. Occurrence information
and methods availability will determine
which phase, or tier, of monitoring the
contaminants will be placed. Both EPA
and stakeholders are also concerned
about contaminants that may be
"emerging" as contaminants of concern.
These emerging contaminants have not
been monitored before, but have the
potential to be found near or in drinking
water supplies or recently have been
identified as potential health problems.
It is not likely that there exists approved
EPA analytical methods for the
"emerging contaminants of concern".
Typically, "research" analytical
methods are used to detect such
emerging contaminants and may be
expensive. EPA will have to either
develop an approved method for
inclusion in a regulatory approach, or
perhaps substitute a regulatory
approach with a study using a single
laboratory and a "research" analytical •
method. The resources needed to
develop an approved analytical method
will face competing resource demands
for other contaminants on the CCL that
also require analytical method
development. In recognition of these
considerations, as described above, the
final rule incorporates an approach with
three monitoring levels, or tiers, referred
to as "Assessment Monitoring,"
"Screening Survey," and "Pre-Screen
Testing".
1. Assessment Monitoring
The first type of monitoring in the
three-tiered monitoring program of
today's rule pertains to the group of
contaminants for which analytical
methods are currently available and are
specified in § 141.40(a)(3), Table 1,
UCMR (1999) List 1, Assessment
Monitoring Importantly, these
contaminants are ones for which initial
data for PWSs indicate that the
contaminants occur in at least two
States or ten public water systems and
should be monitored to assess national
occurrence through the UCMR. Based
on today's rule, all contaminants in
§ 141.40(a)(3). Table 1, List 1 must be
monitored in the Assessment
Monitoring tier of the UCMR Program,
except perchlorate and acetochlor, for
which analytical methods are soon to be
finalized.
In § 141.40, EPA indicates that each
system must conduct UCMR
"Assessment Monitoring" of List 1
contaminants for a twelve-month period
in the first three years (i.e., 2001
through 2003) of a five-year UCMR
contaminant listing cycle (i.e., 2001
through 2005). Large systems must
complete this monitoring in any twelve-
month period within the years 2001 to
2003. Small systems in State Monitoring
Plans must complete the monitoring
according to the scheduled monitoring
identified in those plans within the
period of 2001 to 2003. Section F,
"Representative Sample of Systems
Serving 10,000 or fewer persons,"
describes in detail the selection of the
subset of small systems required to
monitor. The State could specify in the
State Monitoring Plans a schedule that
would correlate with compliance
monitoring. This arrangement should
enable systems to complete UCMR
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50568 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
sampling coincident with their
compliance monitoring for regulated
contaminants during one of the years
wtiep compliance monitoring is
required. However, EPA recognizes that
some large systems may not be required
to monitor for any regulated
contaminants during the five-year
UCMR listing cycle. In that case, such
large systems could monitor for the
unregulated contaminants during any
twelve-month period within the three
years they choose. This approach, as
originally proposed, is responsive to
public comments that UCMR
monitoring be able to be conducted in
conjunction with compliance
monitoring.
EPA is requiring that surface water
systems monitor for four consecutive
quarters in the designated, or, in the
case of large systems, selected,
monitoring year, and that ground water
systems monitor two times
approximately five to seven months
apart in their monitoring year. Under
Assessment Monitoring, systems serving
more than 10,000 persons must conduct
and pay for their own sample collection
and testing. Small systems included in
State Monitoring Plans must collect the
samples with EPA-supplied equipment
and send the samples to EPA-specified
laboratories. EPA will pay for the testing
and reporting. Although the laboratory
may report the information directly to
EPA and provide a copy to the State, the
system still has final reporting
responsibility to ensure that results are
reported to EPA and copied to the State.
Frequency and location of monitoring
ire discussed in section D, "Monitoring
Requirements under the Final UCMR."
"' ' , ' nl I » . Ill
2. Screening Surveys
The contaminants that EPA is
considering for the Screening Survey are
listed in § 141.40(a)(3), Table 1, List 2.
These contaminants are those for which
analytical methods are under
development and for which EPA has
less occurrence data than for the
contaminants on List 1. The purpose of
the Screening Survey is to analyze for
contaminants where the use of newly
developed, non-routine analytical
methods are required. To do this and
still maintain adequate quality of the
occurrence data, EPA wUl use only a
select, controlled group of laboratories.
In addition, the Screening Survey
approach might allow EPA to maximize
scientifically-defensible occurrence data
for emerging contaminants of concern
more quickly than could be obtained
through a more standard unregulated
contaminant monitoring effort. The
Screening Survey could, for example, be
useful where questions concerning
whether a contaminant of concern is in
fact occurring in drinking water and the
range of concentration of that
occurrence. The Screening Survey is
also intended to allow EPA to screen
contaminants to see if they occur at high
frequencies or concentrations that
justify inclusion in future unregulated
contaminant Assessment Monitoring or
at sufficiently low frequencies that do
not require further monitoring, but
allow the Agency to evaluate standard
development.
The contaminants in UCMR (1999)
List 2 will be monitored by a smaller,
statistically selected sample from all
(large and small) community and non-
transient non-community water systems
(about 300 systems total). These systems
will be selected through a random
number generator. Systems will not
have to initiate Screening Surveys until
after EPA promulgates requirements for
Screening Surveys. The sample size
needed for estimating frequencies of
contaminant occurrence are smaller if
the actual occurrence frequencies are
close to 0 or. to 100 percent. When a
contaminant is consistently present or
consistently absent it requires fewer
samples to determine its frequency with
adequate statistical confidence than if it
occurs about half the time. Only 300
PWSs are needed to determine if a
contaminant is present 5 percent of the
time or less frequently, at a 99 percent
confidence level and with a 3 percent
margin of error. (The same criteria
require 1,844 samples when the
frequency could be any number.) If the
contaminant occurrence findings are
above the thresholds established for the
Screening Survey, EPA will include the
contaminant in the next Assessment
Monitoring round (projected to begin in
2006) of the UCMR Program. The
statistical threshold for positive results
from this monitoring to determine if
further monitoring is warranted might
be 1 to 2 percent of systems with
detections. If the contaminant
occurrence were under the threshold,
then no further testing would be
required, and the contaminant may be
removed from the list in a future UCM
rulemaking. EPA requested public
comment on whether the statistical
threshold of 1 to 2 percent of systems
is adequate to make a determination that
further Assessment Monitoring should
be conducted to determine the extent of
contaminant occurrence, and, if not,
what percent should be used as the
threshold for such a determination. One
commenter suggested that EPA should
use a threshold of 3 to 5 percent, but did
not provide any rationale. EPA believes
that 1 to 2 percent is consistent with the
approach that this monitoring is a
Screening Survey to determine whether
the contaminant(s) are occurring in any
public water system. One to 2 percent
occurrence is equal to 3 to 6 systems for
the sample, but statistically this can be
extrapolated to 600 to 1,200 systems out
of all small systems that may have an
occurrence of the contaminants. For a
sample size of 300, occurrence of a
contaminant on the monitoring list in
any system would indicate that the
contaminant occurs at a frequency
greater than 0 (zero). Therefore, EPA
should give further consideration to the
occurrence and concentration of such a
contaminant and may evaluate the
extent of its occurrence nationally. EPA
considers this extent of occurrence to be
significant and to warrant more
extensive monitoring, perhaps even
through Assessment Monitoring.
Another commenter indicated that EPA
should evaluate other factors and not
just the extent of occurrence before
deciding to regulate a contaminant. EPA
agrees with this comment and will
continue to evaluate other factors.
The anticipated analytical methods
that might be used for Screening
Surveys are identified in § 141.40(a)(3),
Table 1, List 2, as "Analytical
Methods." These methods are being
refined for the particular contaminants
on List 2 and are not expected to be
ready for use in an Assessment
Monitoring program. Therefore, as
analytical methods are developed for
groups of contaminants on List 2, EPA
will propose a rule modification for
public comment and will promulgate
analytical methods, minimum reporting
levels and the location and timeframe
for sampling for each contaminant.
Additionally, EPA requested public
comment on two potential outcomes
from the Screening Survey: (1) if the
contaminant is observed at very few or
no PWSs (i.e., less than the threshold of
1 to 2 percent of systems), then the
contaminant may be dropped from the
UCMR (1999) List 2 and no further
monitoring for it will occur; and, (2) if
the contaminant is observed extensively
(i.e., in a higher percentage of PWSs,
such as 5 to 10 percent) and EPA has
health effects data for the contaminant
that indicate a significant concern, then
that specific contaminant may move
directly to the regulation development
stage. In these cases, there may be no
Assessment Monitoring tier of
monitoring activity to provide
additional occurrence data for that
contaminant. One commenter expressed
concern that EPA would move directly
to regulation development after
obtaining results from Screening
Surveys for a contaminant and stated
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that EPA should move the contaminant
up to Assessment Monitoring before
taking any action. EPA believes that an
occurrence of a contaminant in 5 or 10
percent of systems, for example, in the
screening survey may be sufficient to
determine whether or not to initiate
regulation development. EPA may
decide that it needs more information,
in which case, EPA could move the
contaminant to Assessment Monitoring
(List 1) for more extensive monitoring to
inform the regulatory process, but this
may not always be necessary.
With respect to funding the Screening
Survey, EPA will pay for the testing and
reporting (as described in Preamble
section V.G., Reporting of Monitoring
Results) for systems serving 10,000 or
fewer persons. Systems serving 10,000
or fewer persons will be responsible for
sample collection and preparing the
samples for shipment. EPA will pay for
the shipment of these samples to an
EPA-designated laboratory for testing
and for reporting of monitoring results
to EPA, with a copy to the State.
For large systems serving more than
10,000 persons, EPA requested public
comment on whether it should set
performance standards and allow
systems to conduct their own laboratory
analyses in compliance with the
standards, or should approve a limited
but sufficient number of laboratories to
do lab analyses for large systems,
providing for quality control across a
manageable number of laboratories
while allowing competitive pricing of
services. Most commenters, including
water system operators, favored EPA
approval of a limited number of
laboratories, but noted that a sufficient
number of laboratories were needed so
that competitive pricing would be
available.
EPA expects the Screening Surveys
will occur one or two times during the
five-year listing cycle of 2001 through
2005. EPA expects that this Screening
Survey monitoring will occur for groups
•of contaminants, rather than for one
contaminant at a time, depending on
when the different methods are
promulgated and the timing of their
promulgation. Systems selected for the
Screening Surveys will monitor at the
same frequency as for contaminants
under Assessment Monitoring. Should
approval and implementation of the
analytical method for a particular
contaminant become delayed, the
contaminant might be moved into the
category of Pre-Screen Testing,
described next.
3. Pre-Screen Testing
The third tier of the final monitoring
program is "Pre-Screen Testing", which
will be conducted for contaminants
with analytical methods that are in an
early stage of development and at
systems that are determined to be most
vulnerable to the occurrence of
contaminants on the Pre-Screen Testing
list. Pre-Screen Testing means sampling,
testing, and reporting of the listed
contaminants that have newly emerged
as drinking water concerns and, in most
cases, for which methods are in an early
stage of development. Pre-Screen
Testing will be performed to determine
whether a listed contaminant occurs in
sufficient frequency in the most
vulnerable systems or sampling
locations to warrant its being included
in future Assessment Monitoring or
Screening Surveys. Pre-Screen Testing
will only be required after additional
rulemaking.
EPA will select a limited number of
systems (up to 200) to conduct Pre-
Screen Testing, possibly using a random
number generator, selected from up to
25 of the most vulnerable systems
identified by each State, or by EPA if a
State decides not to participate in the
Pre-Screen Testing system selection
process. Up to 200 systems, a smaller
sample size than under the Screening
Survey or-Assessment Monitoring, are
considered sufficient for this type of
monitoring because monitoring will
occur at systems determined to be
vulnerable to occurrence of the
contaminants, based on the
characteristics of the contaminants,
system operation, climatic conditions, .
and land and water resource use. This
monitoring is to determine whether the
contaminant can be found in any public
water system under most likely
occurrence conditions specific to the
contaminant. This tier of monitoring is
not designed to determine the extent of
occurrence. A portion (e.g., 100 to 150)
of these 200 systems may be a different
subset of small systems serving 10,000
or fewer persons than those selected for
the national representative sample. The
reason for this different subset is that
States should identify the systems that
are representative of the most
vulnerable conditions for the
contaminants specified for Pre-Screen
Testing. These most vulnerable systems
may not be those conducting
Assessment Monitoring or the Screening
Survey. It is possible, though, that some
overlap of systems doing Assessment
Monitoring and those selected for Pre-
Screen Testing could occur.
Under Pre-Screen Testing, EPA will
designate or approve a laboratory or
laboratories to conduct sample analysis.
The reason for this testing approach is
that the analytical methods expected to
be used will be emerging from research
development, and most laboratories will
not have any experience with them. For
these laboratories to utilize the new
methods could involve extensive
investment in equipment and training.
Rather than requiring this investment
for contaminants which have uncertain
occurrence in public water systems,
EPA will develop and promulgate
appropriate methods. EPA will also
require that these methods be used by
designated or approved laboratories.
Pre-Screen Testing analysis is
conducted at systems most likely to
have the contaminants to determine
whether further action is warranted and
additional method development is
needed.
Under this approach, once EPA has
developed methods and promulgated
the rule to test for List 3 contaminants,
it will request States to identify at least
5 and not more than 25 systems (based
on the population served by PWSs in
each State) most vulnerable to the listed
contaminants. States will select these
systems from all community and non-
transient non-community systems of all
sizes. Selection criteria for these
systems include States' determination of
systems most vulnerable to the specified
contaminants and numbers of systems
per State based on the population
served in each size category of system.
The States will send the list of systems,
any modification of their State
Monitoring Plans, and the reasons for
their list and modifications (considering
the characteristics of the contaminants,
precipitation, system operation, and
environmental conditions) to the EPA.
EPA will select up to 200 PWSs
nationwide, from the pool of State-
identified vulnerable systems, that must
submit samples of the specified
contaminants. Some small systems
selected may not be part of the national
representative sample of 800 small
systems selected for Assessment
Monitoring. Hence, some small systems
may only be required to sample for Pre-
Screen Testing. States or EPA will
provide instructions to the systems for
the necessary sampling and subsequent
shipping to the EPA laboratory. At this
time, EPA believes that the
contaminants for which Pre-Screen
Testing will likely be required are those
listed in the final rule at § 141.40(a)(3)
Table 1, List 3. Sampling and testing
done for Pre-Screen Testing will most
likely be required in the later years of
the five-year UCMR listing cycle. This
approach will assist EPA in refining the
methods for these contaminants. If EPA
finds any substantial frequency of
occurrence of Pre-Screen Testing
contaminants, the contaminants could
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50570 Federal Register/Vol. 64, No. 180/Friday, September 17, 1999/Rules and Regulations
become part of either the Screening
Survey or part of Assessment
Monitoring in future UCMR lists. Since
the methods for these contaminants will
have to be applied under highly
controlled analytical conditions, EPA
will pay for the shipping and analyses
of these samples for small systems
selected to participate. Large systems
will pay for the shipping and testing of
samples at EPA approved laboratories.
Public comments requested that EPA
provide guidance on the selection of
"most vulnerable" systems and on
reporting requirements for Pre-Screen
Testing, EPA plans to provide this
guidance during the years 2001 and
2002, and obtain public comment before
the guidance is final.
D, Monitoring Requirements Under the
Final
1. Monitoring Frequency
(a) Systems Serving More Than 10,000
Persons
(i) Chemical Contaminants.
The number of persons served affects
exposure to contaminants and resources
necessary to monitor. The final UCMR
program requires large systems serving
more than 10,000 persons to monitor at
each entry point to the distribution
system, or other representative
compliance monitoring location
specified by the State, whether or not
the system applies treatment. If a system
applies treatment, then it must monitor
after treatment. In response to public
comment, EPA modified the rule to
allow alternative sampling points to be
used: sampling points identified by the
State for compliance monitoring under
40 CFR 141.24(0(1), (2). and (3), and/or
source (raw) water sampling points, if
the State uses source water monitoring
as a more stringent monitoring
requirement. If monitoring at source
(raw) water sampling points indicates
detection of any of the contaminants on
the monitoring list, then the system in
most cases will be required to shift its
unregulated contaminant monitoring to
the entry point to the distribution
system. These flexibilities in the
sampling location should enable
systems arid States to coordinate
compliance and unregulated
contaminant monitoring more
extensively.
The law requires EPA to consider the
source of water relative to unregulated
contaminant monitoring requirements
(SDWASection 1445(a)(2)(A)). Over the
twelve-month period of monitoring, the
regulation requires that systems sample
from all entry points to the distribution
system, or other sampling points
specified, representing all principal,
non-emergency sources of water used
over the monitoring period. Surface
water-supplied systems will monitor
each of these points every three months
for a twelve-month period and ground
water-supplied systems will monitor
each of these points two times five to
seven months apart within a twelve-
month period. Today's final monitoring
frequency for surface water systems is
the same as in the previous program.
For ground water systems, the two
sampling events must be approximately
six months apart, increasing the
frequency from one sample in five years
under the previous program to two. The
reasons for this increase are that while
ground water typically moves slowly,
one sample is insufficient to
characterize water quality at any
particular location and will not provide
evidence of any changes over a longer
period of time. Furthermore, some
ground water environments transmit
water more rapidly, potentially resulting
in changes in water quality over shorter
timeframes. From a statistical
standpoint, one sample is not
representative and will not allow the
data to be used for exposure assessment
which uses an average annual value.
This frequency applied to the average of
6.2 entry points to the distribution
system for systems serving more than
10,000 persons will provide sufficient
data for an adequate statistical analysis
of the varied conditions in which these
systems are located.
One of the monitoring events for both
surface water and ground water systems
must occur at the most vulnerable time
of year for the PWS. The rationale for
this approach is that it provides data
representing potential variation in
contaminant concentration over the
course of a year. This potential variation
in concentration is necessary to evaluate
exposure related to contaminant
occurrence. Some systems perform
compliance monitoring on a quarterly
basis and can collect UCMR samples
coincident with their compliance
samples, and therefore provide data on
the range of variation. Other systems
may only conduct compliance
monitoring once every third year and
will therefore have to collect additional
samples under the UCMR. While one
UCMR sample could be collected
coincident with this compliance
sample, EPA is requiring for ground
water-supplied systems to take a second
sample five to seven months later. This
requirement will provide the necessary
data on seasonal variation over a year to
allow consistent exposure assessments
to be done with a range of
concentrations. Stakeholders supported
this option. EPA originally proposed
that the second sample be collected
exactly six months later. State
commenters indicated a need to provide
flexibility to accommodate changes in
monitoring schedules. Therefore, EPA
modified the regulation to allow
monitoring five to seven months before
or after the initial vulnerable period
sampling event.
(ii) Microbiological Contaminants
For microbiological contaminants, the
sampling frequency will be two times
within one year, with samples collected
each time at two different locations after
treatment in the distribution system: a
site representative of water in the
distribution system received by the
general population that the system
serves and a site in the distribution
system representing the maximum
residence time or lowest disinfectant
residual, depending on the contaminant.
The frequency should capture the most
vulnerable time as well as a time five to
seven months later to provide an
average exposure. Furthermore,
precipitation patterns may be a major
factor in contaminant occurrence. Thus,
frequency of sampling should be
tailored to the most vulnerable times
because increased seasonal precipitation
may cany these contaminants at higher
concentrations than other times during
the year.
(b) Systems Serving 10,000 or Fewer
Persons
The final rule states that
approximately one third of the small
systems (serving 10,000 or fewer
persons) selected through the
representative sample, be sampled each
year over a three-year period at the
frequencies indicated in Section D,
"Monitoring Requirements Under the
Final UCMR" (l)(a) above. This allows
a relatively even submission of samples
to be managed and tested by the EPA
laboratory. EPA will pay for the
reasonable costs of monitoring (i.e.,
containers, shipping, testing and
reporting) for this representative sample
of systems, including Assessment
Monitoring, Screening Survey, and Pre-
Screen Testing, and will conduct the
analyses at its designated laboratories.
EPA, therefore will need to be able to
manage the number of samples being
received at any time to closely
correspond to the analytical capacity of
its laboratories. Some public
commenters suggested that sampling for
microbiological contaminants not occur
at the maximum residence time in the
distribution system, but at the point of
lowest disinfectant residual, since the
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Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations 50571
monitoring of concern is for
effectiveness of treatment and booster
disinfection stations that may be in use
in long distribution lines. In response,
EPA added another sampling point at
the "lowest disinfectant residual" in the
distribution system. However, EPA
maintained the original sampling point
location of "maximum residence time"
because, given potential chemical
degradation over long periods of time in
a distribution system, such as for
disinfection byproducts, the location of
maximum residence time can often be
the location of lowest disinfectant
residual and, therefore, highest
likelihood of microbiological
contaminants.
Public comments also addressed the
flexibility in monitoring schedules to
allow for unforeseen events or factors in
field sampling. Specifically, States
asked that system sampling schedules
allow for sampling over a month within
a quarter, rather than exactly three
months later. EPA modified the final
rule to allow sampling by small and
large surface water systems to occur
within the same month in each quarter
and for small and large ground water
systems, to occur any time five to seven
months before or after the initially
selected month within the vulnerable
time.
2. Monitoring Time for Vulnerable
Period
Water quality studies and monitoring
throughout the United States have
clearly shown that contaminant
occurrence and/or concentration vary
over time, both seasonally as well as
•from year to year. The seasonally of
occurrence, or period of peak
concentration of contaminants,
commonly varies with seasonal changes
in the hydrologic cycle in relation to the
source of contaminants and their fate
and transport characteristics.
Particularly for land-applied or land-
disposed contaminants, the increased
flux of water mobilizes the
contaminants and moves them into
surface or ground water flow systems.
For the most vulnerable of water
systems, such as surface waters,
unconfined shallow ground water and
karst flow systems, for example, higher
levels of contaminant concentrations
typically occur during annual runoff
and recharge periods. For much of the
United States, east of the Rocky
Mountains, many studies have shown
that the season of greatest vulnerability
for contaminant occurrence is the late-
spring, early-summer runoff-recharge
period, particularly for contaminants
such as pesticides and nitrate (e.g.,
Larson et al., 1997; Barbash and Resek,
1996; Hallberg, 1989a,b). For deeper,
more confined ground water systems,
defining vulnerable periods is much
more difficult. The exact flow path and
time of travel are much greater and more
complex and are dependent upon many
factors unique to a particular well and
aquifer setting (e.g., Hallberg and
Keeney, 1993). There is no generality
that can be applied to these latter
settings.
Because occurrence may vary
seasonally, it is important to try to
capture these vulnerable periods in a
one-time survey of contaminant
occurrence such as the UCMR.
Statistical studies of sampling strategies
in surface water (e.g., Battaglin and Hay,
1996) have shown that incorporating
sampling during spring and early
summer runoff periods provides a more
accurate representation of annual
occurrence than random quarterly
sampling (that can avoid these months).
Ground water studies (e.g., Pinsky et al.,
1997) suggest that the more vulnerable
ground water settings also show peaks
during these periods. The default
vulnerable period for sampling for the
UCMR has been designated to coincide
with this period of peak vulnerability
for much of the United States: one
sample must be collected during May,
June, or July, unless the State has better
information to designate another period.
Also, for surface waters, three additional
samples will be collected throughout
the year, and for ground water systems,
one additional sample will be collected
five to seven months before or after the
vulnerable time. This additional
sampling will also capture the winter
recharge and runoff period that may be
more vulnerable in the western coastal
regions or warmer southern climates for
some contaminants. In the case of some
deeper ground water systems, States or
systems may have additional knowledge
of seasonal vulnerability patterns, in
which case the State can designate an
alternative period for sampling.
Public comments generally supported
monitoring in a vulnerable time, but
desired flexibility in establishing the
time and frequency. The rule already
provided flexibility in selecting a time
within the May to July period for a
sampling event. However, because the
statistical approach requires
consistency, today's rule enables a State
to determine the alternate vulnerable
time for monitoring, rather than each
system using its own criteria for
choosing a vulnerable time. With
respect to frequency, the statistical
approach requires that systems monitor
with the same frequency so that a
national frequency distribution can be
developed. This precludes the State or
a system from establishing its own
monitoring frequency.
Two commenters indicated that
pumping rate and not hydrologic factors
accounted for variations in contaminant
concentration, with higher pumping
rates coinciding with higher
concentrations. No specific data were
offered in support of these comments.
EPA believes that many factors may
account for higher contaminant
concentrations during certain seasons.
While pumping rate may be a factor,
hydrologic factors are documented as
having a significant influence in
concentrations of pesticides and other
contaminants, as noted previously. A
State may use pumping rates as a basis
for designating an alternative vulnerable
time if determined appropriate.
3. Monitoring Location
In § 141.40(a)(3), today's action
identifies entry points to the
distribution system (EPTDS) after any
treatment, or the sampling points
specified by the State for compliance
monitoring under 40 CFR 141.24(f)(l),
(2), and (3), representative of each
principal, non-emergency water source
in use over the twelve-month period of
Assessment Monitoring, as the sampling
locations for List 1 contaminants. Also,
two sites in the distribution system (a
site representative of water in the
distribution system received by the
general population that the system
serves and a site in the distribution
system representing the maximum
residence time or the lowest disinfectant
residual) are designated for
microbiological or distribution system
contaminants. Sampling at entry points
to the distribution system after any
treatment follows the existing regulatory
approach for currently regulated
contaminants and provides data for
exposure assessment.
(a) Chemical Contaminants
The chemicals in this final rule
(UCMR (1999) List 1) are all compounds
that can enter a public water supply
from the external environment (in
contrast to disinfection byproducts, for
example). The monitoring location is at
the entry point to the distribution
system after treatment, representative of
each principal non-emergency source of
water in use over the twelve-month
monitoring period, which will ensure a
nationally consistent data set and will
provide consistent data for exposure
assessment. In response to State and
water system commenters, EPA also
provided flexibility in the final rule to
allow sampling of source (raw) water
sampling points. However, if a listed
contaminant is detected through source
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50572 Federal Register/Vol. 64, No. 180/Friday, September 17, 1999/Rules and Regulations
water sampling and testing, then the
monitoring location must be shifted to
the entry point to the distribution
system (unless there is no treatment)
and follow the monitoring frequency
specified in the rule for the contaminant
and water source type.
(b) Microbiological Contaminants
The sampling locations for
microbiological contaminants are
different from those for chemical
contaminants because the most likely
locations with microbiological
contaminants may be in the distribution
System, or, for some systems, in source
water. Two sampling locations were
considered! in the development of this
regulation and are included in the
reporting requirements under 40 CFR
141.35(d}. No microbiological
contaminant is on List 1 for Assessment
Monitoring so the two sampling points
are not now required. When
microbiological contaminant monitoring
is required, one of the samples will be
at the site below a representative entry
point to the distribution system that is
used for taking total coliform samples;
this sample will represent general
exposure. The second sample will be in
the distribution system that has the
maximum residence time or lowest
disinfectant residual, representing the
extreme exposure of the population at
this point in the distribution system.
These sampling points were suggested
by stakeholders. EPA will consider
activating these sampling points for
microbiological contaminants when
their analytical methods are determined
to be ready for Assessment Monitoring,
Screening Survey or Pre-Screen Testing
through separate rulemaking. Over the
twelve-month period of monitoring,
systems Would sample at locations
representing each principal, non-
emergency source of water used over the
monitoring period, to the extent
possible. One commenter suggested that
distribution system samples be taken at
sites used for sampling total
trihaloniethanes CTTHMs). EPA will
consider TTHM sites when it proposes
methods for microbiological
cbniamlriahts or other contaminants
likely to occur in distribution systems.
Currently, it is not possible to assess
whether or not all of the microbiological
contaminants (including those on List 3)
are likely to be found at any one
sampling location, or that one sampling
location is best to potentially identify all
microbiological contaminants. The
occurrence data needs may differ for
different contaminants. Different
portions of the water supply and
distribution system may be more likely
locations of particular microbiological
contaminants/occurrences. Therefore,
the sampling location for each
microbiological contaminant may need
to be contaminant-specific and related
to the likelihood of occurrence.
As a result, for the microbiological
contaminants on Lists 2 and 3 of the
rule today, EPA has not identified a
sampling location or locations. For some
of the microbiological contaminants,
source water may be the most
appropriate sampling location. EPA will
specify sampling locations at the time
public comment is requested on the
specific monitoring requirements for
microbiological contaminants.
4. Quality Control Procedures for
Sampling and Testing
To assure that the data collected
under this final regulation are of
sufficient quality to meet the
requirements of its intended uses, EPA
is requiring the use of the analytical
methods and procedures in
§ 141.40(a)(3), (4), and (5) and Appendix
A for monitoring. Also, additional
guidance for quality control and
analytical confirmation are specified in
the "UCMR Analytical Methods and
Quality Control Manual", available by
the time this rule is published. This
final regulation covers quality control
steps for all sampling and testing under
this program. Today's final rule requires
that all monitored systems follow these
methods and procedures in organizing
and conducting their UCMR sampling
and testing. Systems must also ensure
that the laboratories they use to analyze
samples use these approved methods
and procedures. The specific quality
control requirements addressed in
§ 141.40(a)(3), (4) and (5) and Appendix
A of the final rule include: sample
collection/preservation; sample
transport; sample and sample extract
holding time and storage; sample
analyses/quality control requirements,
including quality control (QC)
requirements, calibration, calibration
verification, laboratory reagent (method)
blank, quality control sample, laboratory
duplicates, sample matrix spike and
matrix spike duplicate, internal
standard, surrogate standard, method
detection limit determination, minimum
reporting level; confirmation; and
reporting requirements. EPA believes
that specifying the quality control
requirements for UCMR sampling and
testing will enable the Agency to have
a high degree of confidence in
determining the extent and range of
concentrations for the contaminants on
the UCMR (1999) List, since they are not
regularly tested for nationally.
5. Monitoring of Routinely Tested Water
Quality Parameters
In addition to the contaminants to be
monitored, several chemical and
physical parameters are important
indicators of water quality and may
contribute to the likelihood of
contaminants being found in drinking
water. EPA requested public comment
on whether it should require the
monitoring and reporting of these
routinely tested parameters, usually
associated with water quality analyses,
to provide for a more thorough scientific
understanding of the occurrence of
unregulated contaminants. These
chemical and physical parameters are
not added to the UCMR (1999) List
because they are not contaminants, but
rather they provide supplementary data
about the sample results which will
facilitate their interpretation and use in
regulatory decisions. Public comments
indicated that for some systems and
States, these chemical and physical
parameters are routinely tested for, and
in others, they are not. One commenter
stated that temperature and pH were
important for chemical contaminant
occurrence and degradation. Another
commenter indicated that analyzing for
these water quality parameters is
essential to managing his system's
water. In response, EPA has revised the
rule to require that for organic and
inorganic chemical samples, pH be
reported for the sampling event of each
sampling point. Since no supporting
information was provided, EPA
determined that while temperature may
be important for microorganisms, it is
not expected to affect the results for
chemical contaminants because the
storage and transit temperature
requirements in the approved methods
will minimize the loss of target
contaminants due to any physical,
chemical or biological processes. For
microbiological contaminants,
temperature, pH, free disinfectant
residual, and total disinfectant residual
must be reported. These required water
quality parameters are listed in § 141.40
(a)(4)(i) Table 2, Water Quality
Parameters To Be Monitored With
UCMR Contaminants. These water
quality parameters must be reported as
analytical results along with other
results and data elements.
6. Relation to Compliance Monitoring
Requirements
Currently, compliance monitoring for
regulated contaminants is coordinated
on a three-year cycle. All public water
systems that are required to monitor for
specific contaminants a minimum of
one year out of every three, six, or nine
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Federal Register/Vol. 64, No. 180/Friday. September 17, 1999/Rules and Regulations 50573
years, depending on the contaminant
and its occurrence in the system. The
existing unregulated contaminant
monitoring requirements and the final
revised UCMR require monitoring
during one year out of every five years.
EPA provides flexibility in this final
UCMR so that public water systems: (a)
only have to monitor for unregulated
contaminants during one twelve-month
period every five years (unless the State,
at its discretion, determines that PWSs
should conduct more frequent
monitoring); (b) can use previously
State-specified compliance sampling
points, including source water sampling
points; and (c) choose a sampling time
within quarters or three-month periods
specified in the rule. Hence, the
compliance monitoring and the UCMR
monitoring can be coordinated, to the
extent practical, by conducting UCMR
monitoring during a coincident year
during which compliance monitoring is
required. The years within which the
unregulated contaminant monitoring are
required to occur are specified in
§ 141.40(a)(3), Table 1, Unregulated
Contaminant Monitoring List, column 6.
7. Previous Monitoring of the
Contaminants on the Final UCMR
(1999) List
Some PWSs may already have
monitored for or want to monitor before
the rule's effective date of January 1,
2001, for some of the contaminants
identified on the final UCMR (1999) List
because of local or State concerns about
the possibility of those contaminants
occurring in drinking water. At the time
of proposal, EPA was concerned about
allowing systems to report monitoring
results for samples taken and tested
prior to promulgation of the UCMR.
EPA was concerned that such results
might not be comparable to results
obtained under this revised UCMR
Program because of differences in
sampling and analytical protocols, as
well as the sampling schedule. Other
factors thought to compound the
problem of comparability included: (1)
monitoring methods may have changed
or improved; (2) water quality changes
over time; and, (3) today's action
requires reporting of a net increase of
seven additional data elements, which
will allow various, consistent
comparisons to be made and data to be
aggregated nationally based on current
sound-science and quality assurance/
quality control consistency. However,
EPA received comments recommending
that previously collected data should be
accepted for the unregulated
contaminants on the monitoring list as
long as they meet all the requirements
of this final rule. In response, EPA
reevaluated the circumstances under
which previously collected (also
referred to as "grandfathered" or
"grandparented") data could be
accepted, given the statistical and
quality assurance/quality control
requirements of the UCMR Program.
EPA has modified the regulation to
allow previously collected data to be
reported, as long as the data meet the
sampling, testing and reporting
requirements specified in 40 CFR
141.35(d) and 141.40(a)(3), (4), (5) and
Appendix A. This change will allow for
early monitoring and reporting for
MTBE, as long as it meets the
requirements of the UCMR. By doing so,
EPA is responding to one of the
recommendations of the Blue Ribbon
Panel on Oxygenates in Gasoline, a
panel appointed by EPA Administrator
Browner, to evaluate the issues posed by
the use of MTBE in gasoline. This
recommendation consisted of
accelerating the implementation of the
UCMR, by allowing systems to sample
for MTBE prior to the implementation
date of January 1, 2001.
E. Waivers
1. Waivers for Systems Serving More
Than 10,000 Persons
Section 1445(a)(2)(F) of SDWA allows
a State to obtain a waiver of UCMR
monitoring for specific contaminants if
the State demonstrates that the UCMR
listing criteria do not apply in that State.
These criteria are:
(a) the criteria for listing a
contaminant in the occurrence priorities
list in the CCL or the regulatory process
identifying contaminant occurrence in
two or more States; and
(b) whether an analytical method
exists for the contaminant.
When a State makes such a
demonstration for a waiver of a specific
contaminant on the monitoring list, EPA
may waive monitoring for that
contaminant in that State for large
systems (serving more than 10,000
persons) only.
Stakeholders indicated that waiver
requirements should be sufficiently
stringent to obtain the most
representative national data possible,
including non-detections of
contaminants on the UCMR (1999) List.
Since only the UCMR listing criteria in
(a) are relevant to a State-specific waiver
and based on stakeholders' concern that
the waiver be narrowly applied, EPA is
requiring that this waiver be applied
only where the State can demonstrate
that the contaminant has not been used,
applied, stored, disposed, released, or
detected in the source waters or
distribution systems in, the State in the
past 15 years and that the contaminant
does not occur naturally (such as growth
in a system or air deposition) in the
State. Source Water Assessments
provided for under Sections 1453 and
1428(b) of SDWA may be used as the
basis for these waivers if the
assessments specifically address the
contaminants) on the UCMR List for
which a waiver is sought. Table 3, Uses
and Environmental Sources of
Contaminants for the Monitoring List,
presents the uses and sources of the
contaminants included for the final
UCMR (1999) List. A State can apply for
a waiver from monitoring for specific
contaminants, but must receive EPA
approval to waive the monitoring.
While some chemical contaminants
may only be discharged into the
environment in regional or local areas,
microbiological contaminants may be
ubiquitous. However, previous
monitoring results over time may
provide information useful to waiver
determinations for microbiological
contaminants.
Public comments on system-specific
waivers ranged from not allowing
waivers for any systems to providing
waiver procedures for individual
systems. EPA decided that such waivers
are not provided by the statute and
would be generally inconsistent with
the nature of a program that relies on
nationally representative data.
Detections and non-detections are
equally important in deciding whether
to regulate a contaminant. If waivers are
given to systems not expected to have
occurrence of a particular contaminant
or group of contaminants, then the
resulting data set will be biased toward
systems having detections, potentially
contributing to an incorrect conclusion
about contaminant occurrence and
regulation. EPA did not change the rule
to allow other circumstances under
which contaminant monitoring waivers
could be given.
2. Waivers for Small Systems in State
Plans
EPA is not allowing waivers to be
granted for small systems serving 10,000
or fewer persons in State Plans for the
national representative sample.
Stakeholders also supported this
position. The systems in State Plans will
be statistically selected with the
assumption that all systems in a
particular size category and water
source type have an equal probability of
being selected. Non-detections are just
as important as detections of
contaminants for national analysis.
Waiving contaminants to be monitored
in certain States not expecting to have
such contaminants biases the
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50574 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
representative sample toward
detections. Selecting the small systems
to be included in the State Monitoring
Plans for the representative sample
through a statistical process effectively
waives ninety-seven percent of the
systems from the final monitoring
requirements (based on using 99 percent
confidence level with three percent
allowable error). Therefore, EPA
rejected waivers for systems serving
fewer than 10,000 persons because this
approach is contradictory to obtaining a
scientifically sound data set that
provides the basis for a scientific
statistical analysis. The rule was not
changed in this regard.
TABLE 3.—USES AND ENVIRONMENTAL SOURCES OF CONTAMINANTS FOR THE MONITORING LIST
Contaminant name
CASRN
Use or environmental source
Proposed Chemical Contaminants
1,2-diphenyihydrazine
2-methyl-phenol
2,4-dlchtorophenol
2,4-dlnitrophenol
2,4-dlnftrotoIuene .
2,4,6-trichlorophenol
2,6-dinitrotoiuene
Acatochjor
Alachtor ESA
DCPA di-add dcgradate
DCPA mono-acid degradate
DDE
Dtazlnon
Disuifotoh
Diuron
EPTC
Fonofos
Lead-210 (Pb-210)
Unuron
Molinate
MTBE
Nitrobenzene
Perchlorate
Potonium-210 (Po-210)
Prometon
RDX
Terbacil
Terbufos
122-66-7
95-48-7
120-83-2
51-28-5
121 14—2
88-06-2
606-20-2
34256-82-1
2136-79-0
887-54—7
72-55-9
333-41-5
298-04-4
330-54—1
759-94-4
944-22-9
14255-04-0
330_55_2
2212-67-1
1634-04-4
98-95-3
14797-73-0
13981-52-7
1610-18-0
121-82-4
5902-51-2
13071 79-9
Used in the production of benzidine and anti-inflammatory drugs
Released in automobils and diesel exhaust coal tar and petroleum refining and
wood pulping.
Chemical intermediate in herbicide production
Released from mines metal and petroleum plants
By-product of fossil fuel burning used as bactericide and wood/glue preservative
Used as mixture with 2 4-DNT (similar uses)
Herbicide used with cabbage citrus coffee and corn crops
Degradation product of alachlor an herbicide used with com bean peanut and
soybean crops to control grasses and weeds.
Degradation product of DCPA an herbicide used on grasses and weeds with fruit
and vegetable crops.
Degradation product of DCPA an herbicide used on grasses and weeds with fruit
and vegetable crops.
Degradation product of DDT a general insecticide "
Insecticide used with rice fruit vineyards and com crops
Insecticide used'with cereal cotton tobacco and potato crops
Herbicide used on grasses in orchards and wheat crops
Herbicide used on annual grasses weeds in potatoes and corn
Soil insecticide used on worms and centipedes
Part of the uranium decay series naturally occurring
Herbicide used with com soybean cotton and wheat crops
Selective herbicide used with rice controls watergrass
Octane enhancer in unleaded gasoline
Used in the production of aniline which is used to make dyes herbicides and
drugs.
Oxygen additive in solid fuel propellant for rockets missiles and fireworks
Part of the uranium decay series naturally occurring
Herbicide used on annual and perennial weeds and grasses
Used in explosives; ammunition plants
Herbicide used with sugarcane alfalfa and some fruit etc
Insecticide used with com sugar beet and grain sorghum crops
Microbiological Contaminants
Adenoviruses
Acrcmonas
Cyartobacteria (Blue-green algae), other
freshwater algae and their toxins.
Ca!sciviruses
Coxsackieviruses
Eehoviruses
fMcobacterpylori .".
Mferosporldia
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Fecal sources; hand to mouth transmission.
Present in all freshwater and brackish water.
Bloom in surface water bodies; produce toxins.
Contaminated food and water, raw shellfish.
Fecal sources; hand to mouth transmission.
Fecal sources; hand to mouth transmission.
Fecal sources; hand to mouth transmission.
Occur in rivers, ponds, lakes, and unfiltered water.
F. Representative Sample of Systems
Serving 10,000 or Fewer Persons
As required by section 1445 (a) (2) (A)
and (Cj, the regulation requires that only
a representative sample of public water
systems serving 10,000 or fewer persons
must monitor for unregulated
contaminants. As previously explained,
only community and non-transient non-
" community systems are required to
monitor for unregulated contaminants
under this action. Therefore, the
representative sample will include only
community and non-transient non-
community systems serving 10,000 or
fewer persons. The representative
sample must be of sufficient size to
gather the necessary information on
occurrence of unregulated contaminants
to determine whether or not to regulate
them, while not burdening every water
system with the expense of monitoring.
The number of systems selected within
each of three size ranges of small
systems will be based on the proportion
of the State's population served by
systems in that size range. (An example
appears in Section 5.(a), "State Plans for
the Representative Sample".) The small
systems in the national representative
sample will be selected using a stratified
random sampling process. This process
will utilize a random number generator
to choose a statistically determined
number of systems in each State,
considering the proportion of the
population served by CWSs and
NTNCWSs by water source type (i.e.,
ground or surface water) and system
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Federal Register/Vol. 64. No. ISO/Friday, September 17, 1999/Rules and Regulations 5O575
size category (i.e., 25 to 500 persons,
501 to 3,300, and 3,301 to 10,000)
within the water source type. The
regulation stipulates that the national
representative sample is the basis for the
State Monitoring Plan in each state. The
use of this statistical approach is
designed to take into account different
system sizes, types of systems, the
source of supply, contaminants likely to
be found, and geographic location. EPA
believes that the statistical process for
selecting systems to monitor must yield
data that are sufficient to answer
questions about occurrence of
contaminants on a national scale for use
in exposure assessments and technology
evaluations of alternative treatments at
a PWS and in its watershed. These data
should also be sufficient to answer
questions on a broad multi-state scale,
such as systems classified by size or
source of water, particularly when
combined with data for the 2,774 large
systems.
Under this action, small system
monitoring will be too sparse to answer
questions about occurrence at the scale
of a single State. The number of systems
required for evaluation of occurrence in
a single State is far greater than, and
thus more costly than, those needed for
the broader national evaluations
required under the Act to determine
whether or not to regulate a
contaminant and to assist in developing
future drinking water regulations.
1. System Size
Based on statistics reported in the
Safe Drinking Water Information System
(SDWIS) database, the following
numbers of systems (1997 data) by size
will approximate the universe from
which a representative sample of
systems serving 10,000 or fewer people
will be taken for the national
representative sample plan. These
system size categories are used in other
statutory and regulatory
characterizations of systems, and are
applied under the existing rule for
unregulated contaminant monitoring for
the scheduling of sampling. The
relevant system and population
information (1997) for systems serving
10,000 or fewer persons is:
No. of people served in PWS size range
25-500 .
501-3,300
3,301-10,000
Total .'.
No. of PWSs
in size range
48,100
14,126
3,410
65,636
Population served nationally
CWS
5,249,577
19,918,106
25,236,059
50,403,742
NTNCWS
2,379,034
2,724,728
401,579
5,505,341
Considering all community water
systems and nontransient non-
community water systems that do not
purchase their water supplies, 65,636
PWSs are in the size range for small
systems as defined in Section 1445. In
response to public comments that
indicated the appropriateness of
including purchased water systems,
EPA revised this rule to cover systems
purchasing water from other systems if
their distribution systems are the
locations of the maximum residence
time or lowest disinfectant residual in
relation to the combined water seller-
purchaser distribution system.
Purchased water systems will not be
required to monitor for contaminants for
which the sampling location is specified
as the entry point to the distribution
system because they could bias results
by potentially causing double counting
of contaminant occurrence.
2. System Type
(a) Public Water System Monitoring
Under today's action, all public water
systems serving 10,000 or fewer
persons, except transient non-
community systems, will be considered
for monitoring, but only a subset will be
selected for the national representative
sample. Purchased water systems will
be excluded from UCMR monitoring for
contaminants where the sampling point
is identified as the entry point to the
distribution system. Public water
systems owned and/or operated on
Tribal lands by Tribes will have the
same probability of being selected for
the national representative sample as
any other system in its water source-
system size category. EPA will identify
the size of the representative sample
and the specific systems required to
monitor and send the list of systems to
the States for review and inclusion in
State Monitoring Plans (discussed in
Section V. F. 5).
(b) Nontransient Non-Community Water
Systems
Nontransient non-community water
systems (NTNCWSs) represent schools,
hospitals and other facilities in
communities that serve the resident
population but have their own water
supply systems. Approximately 20,000
systems of this type exist in the United
States. Today's final regulation at
§ 141.40(a)(l)(iii) includes NTNCWSs as
a separate type of water system to be
included in the representative sample
for monitoring. Typically, these systems
are closely associated with a local
resident population and may be a
significant source of water consumed by
that population over a lifetime. The
selection of NTNCWSs will use the
same statistical process as for CWSs,
with systems grouped within a State by
water source type and size category.
NTNCWSs are considered separately to
avoid double-counting the population
served when conducting exposure
assessments of both small CWSs and
NTNCWSs, while allowing weighting of
lifetime water consumption by system
type.
(c) Transient Non-Community Systems
Transient non-community water
systems represent systems providing
drinking water to transient populations
such as at a restaurant in a rural location
or a highway roadside rest area. About
97,000 of these systems exist in. the
United States; their location and type
are highly variable. It will be difficult to
extrapolate exposure from monitoring
results, given the very short-term nature
of the systems' use by individuals who
may not be in the area for more than a
few hours or days. Because of problems
with implementation and cost for
sampling such a large and highly
variable set of typically very small
systems, EPA has excluded transient
systems from all unregulated
contaminant monitoring requirements
in this final rule. In this regard, this
action is consistent with the current
UCMR Program. Four of the five public
commenters addressing transient
systems supported exclusion of
transient systems from requirements for
unregulated contaminant monitoring.
3. Geographic Location
SDWA Section 1445 specifies that
State plans should consider "geographic'
location" when selecting a
representative sample. This is
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50576 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
accomplished at the broadest level by
selecting systems from each State.
However, within a State, the sources of
water may not be evenly distributed
across that State, especially surface
waters. Cities transfer wafer across
watershed boundaries, or move water
from one State to another. To best
represent water being consumed by
individuals, EPA defines "geographic
location" in the representative sample
for the final rule today as the location
of the source of water, rather than as an
even distribution of points across the
State. For example, if 40 percent of the
people in a State obtain their water from
one water source type (e.g., surface
water), 40 percent of the systems
selected for the representative state
sample should be from that source type,
even if this results in points unevenly
distributed across the State. This
distribution should be accommodated
by allocating systems based on the
population served nationally and in
each State stratified by water source and
system size category.
I, Likelihood of Finding Contaminants
Section 1445(a)(2)(A) requires that the
UCMR Program take into account the
likelihood of finding a contaminant in
establishing variable monitoring
requirements for systems. The final rule
allows the UCMR Program to focus on
monitoring for contaminants that are
expected to be found nationally or
within several regions of the United
States. Therefore, the expectation of
finding the contaminants nationally is
fundamental to the approach of the
representative sample and its statistical
method of selection. The '"likelihood of
finding contaminants" factor is
accommodated by the step-wise three-
tiered approach of Pre-Screen Testing,
Screening Survey and Assessment
Monitoring.
'it ' • .1' , "
5. State Plans for the Representative
Sample
, '".j ;!;' ' ' jj t ""I"
As discussed previously, Section 1445
(a)(2)(C) allows States to develop State
Monitoring Plans (also referred to as
"State Plans") to assess the occurrence
pf unregulated contaminants for small
systems In the State. EPA believes that
the development of State Plans is
affected by two other considerations: (i)
die State plans must fit together into a
national representative sample so that it
is, in fact, nationally "representative,"
and (ii) EPA will pay for the reasonable
costs of testing and laboratory analysis
necessary to carry out monitoring at
State Plans, pursuant to Section
1445(a)(2)(C)(U).
(a) Representative State Plans
To have representativeness at the
national level while at the same time
allowing each State to develop a "State
Plan," the testing for which EPA will
fund, the Agency will take the following
approach. Based on a statistical random
selection process applied to all CWSs
and NTNCWSs nationally using the
average population served by systems
and water source type (surface or
ground water to ensure geographic
coverage) within service-size categories
(25-500, 501-3,300, 3,301-10,000
persons), EPA will select at least twice
as many CWSs and NTNCWSs as
required for the national representative
sample. EPA will use a random number
generator to select these systems. These
systems will be divided into an "initial
plan" list and a "replacement list" to
allow for replacement of systems on the
list with systems from the replacement
list, by States. The representative
sample will be allocated on a State
basis, and then stratified by water
source type and then by service size
category within each water source type.
EPA will use the percentages of the
populations served in each water
source-system size category to further
allocate the systems in each State. The
"initial plan" list of systems will
identify those systems tentatively
selected by EPA for each State. To
establish a State Plan for small system
monitoring, a State may enter into a
Memorandum of Agreement (MO A)
with EPA to take a partnership role in
the development and implementation of
the State Plan. By agreeing to participate
in the process for the State plan through
the MOA, the State must accept the
EPA-selected systems on the "initial
plan" as its plan, or review the list to
determine which systems should be
removed from the list because of such
factors as closure, merger, or water
purchase arrangement and submit a
modified plan. The State must replace
the system(s) they remove from the list
with the water system(s) from the
"replacement list" in the order the
systems are listed in the replacement
list, thus creating a "modified plan."
The State, in either case, must inform
the EPA of the State's choice of plan
(i.e., "initial" plan or "modified" plan)
along with reasons for removing and
replacing systems on the "initial plan"
within 60 days of receiving the "initial
plan." If the State decides not to enter
into an MOA with EPA for the State
Plan process, then the EPA will consult
with the State before the State adopts
the "initial plan" as its State Plan. In a
State with an MOA, the State Plan will
include a process for the State to inform
the public water systems of their
responsibility to monitor and report
results, their vulnerable time period,
other monitoring times, sampling
instructions, and of their participation
in the screening survey and pre-screen
testing. The EPA will inform systems of
their inclusion in the representative
sample if the State chooses not to enter
into an MOA for the State Plan. This
approach ensures a nationally
representative set of systems and allows
a State flexibility to modify EPA's
"initial plan" with minimal burden.
EPA will develop and provide initial
plans to States and Tribes in the first
half of year 2000 to allow sufficient time
for State/Tribal review and
modification, and for informing systems
selected for the State Plans.
Statistical Approach. Under today's
action, the representative sample of
small public water systems will be
composed of a subset of systems which,
in the aggregate, represent the public
water systems of the three small system
size categories within the United States.
Within a State, public water systems
will need to be selected so that the
proportion of persons served by the
systems sampled is as close as possible
to the proportion of persons served by
that system size category within each
water source type for that State. The
portion of the national representative
sample within a State's boundaries will
become that State's Monitoring Plan,
after review and possible adjustment by
the State, and then EPA review.
For the small systems considered, a
representative sample size of
approximately 800 systems will provide
a confidence level of 99 percent with an
allowable error of plus or minus 1
percent. This number of systems is
statistically derived to allow population
weighting for exposure assessment.
Because of population weighting in the
selection of the representative sample,
systems are a surrogate for the number
of people being monitored for
unregulated contaminants in their
drinking water. Since population
exposure assessment is the principal use
of the data in the regulation
development process, the quantity of
interest is the fraction of people
exposed, rather than the fraction of
systems affected. However, the law
requires measuring contaminant
occurrence at systems and it is more
efficient to measure at systems. So the
population weighted plan allows EPA to
recognize systems providing drinking
water to their service population as a
surrogate for people. When the goal is
exposure assessment, then a population
weighted sampling plan for systems is
optimal. The results can also be used to
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Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations 50577
estimate the number of systems affected,
although the selected population
weighted plan is not optimal for this
purpose.
The results will also be useful for
analysis of contaminant occurrence at
small systems in national analyses by
water source and system size categories
or strata, with a confidence level of 95
percent and a one percent margin of
error. EPA will allocate systems to each
State, water source type and system size
category by: (1) estimating the
population served by all small CWSs in
each State, (2) dividing this population
into the population served in each water
source type-system size combination to
derive a percentage, and (3) multiplying
the percentage by the number of small
systems in the State, with the result
being the number of systems allocated
to each water source-system size
category. This allocation is a statistical
stratification of systems by water source
type and system size category. The
approach ensures that each State has
systems allocated to it for its State Plan.
To accomplish this allocation of systems
to each State, EPA will add a sufficient
number of small CWSs and NTNCWSs
to the statistically derived number for
the representative sample to allow each
State to have a plan that will then fit
into the national representative sample,
with each State having at least two
systems. Once monitored, the results of
the representative sample of small
systems will then be combined with
large system results in an overall
national analysis of contaminant
occurrence in systems. EPA believes
that this sample size will provide an
adequate level of confidence,
considering size, type (community and
non-transient non-community water
systems), geographic location (State),
and water source. EPA also believes that
this approach provides sufficient
information for the decision processes
drawing on UCMR monitoring data for
systems serving 10,000 or fewer
persons, while keeping testing costs at
a manageable level. This number of
systems should be sufficient to
statistically evaluate whether a
contaminant occurs in a specified
proportion, such as 2 or 3 percent of the
population (using systems as a
surrogate). This number of systems,
confidence level and allowable error
will enable EPA to: (1) evaluate the
statistical significance of contaminant
occurrence with low frequency and (2)
compute the percent of systems for
occurrence nationally, combining the
results of both small and large systems.
Further rationale for using a small
number of systems and small allowable
error (confidence interval) in calculating
the number of systems to be included in
the representative sample is provided in
the monitoring results from previous
unregulated contaminant monitoring
under the existing program. EPA has
results from over 28,000 systems from
the unregulated contaminant monitoring
. activities of 1988 to 1992 (the first
round of unregulated contaminant
monitoring under the existing program)
that indicate that of the 34 contaminants
required to be monitored at that time, 30
occurred at less than 2 percent of
systems and, of those, 27 occurred at
less than 1 percent of systems. Ten of
these contaminants were selected for the
Contaminant Candidate List "Regulatory
Priorities" (see 64 FR 23403) and all of
the ten contaminants occurred at less
than 2 percent of systems and eight, at
less than 1 percent.,Of the eight
contaminants occurring at less than one
percent of systems, four have health
effects values within the concentration
range of contaminant occurrence
(bromomethane [a pesticide], 1,3-
dichloropropene [a pesticide],
hexachlorobutadiene [a solvent], and
1,1,2,2-tetrachloroethane [asolvent]),
and consequently may be considered for
future regulation. These data point at
the need to focus at the low end of
occurrence. Using a small allowable
error minimizes the chance of EPA
incorrectly deciding whether or not to
regulate a contaminant based on
occurrence. Once EPA evaluates health
effects data, contaminant occurrence
among States and systems, contaminant
sources, treatment technologies, and
other relevant information, the small
allowable error allows EPA to make
regulatory determinations with a high
degree of confidence.
If, based on prior information (e.g.,
from a Screening Survey or Pre-screen
Testing), EPA determines that the listed
contaminants occur in a different
percent of systems at a different
statistical confidence level and/or
allowable error providing scientifically
defensible monitoring results, then EPA
may apply a different likely percent of
systems, confidence level, and/or
allowable error to determine a smaller
representative sample size. The
statistical approach for specifying the
number of systems by water source type
(ground water, surface water or ground
water under the direct influence of
surface water) and systems size is as
follows:
The number of systems, n, required in
the representative sample is determined
by the allowable error (±d) around the
estimate for p, the proportion of systems
(a population-weighted surrogate for
people) which exceed a criteria (e.g.,
detection level) of interest. Based on the
binomial distribution in statistics, the
number of systems n which must be
sampled for a likely proportion p of
people (systems as a surrogate) with
contaminant occurrence within the
allowable error dwith confidence (I—a)
is approximately:
(D-
The number of systems to be sampled,
n, does not depend on the total number
of systems available. The number from
the standard normal distribution, z, is
obtained from a table of the standard
normal distribution, representing a
collection of data following a "bell-
shaped curve" which have a
(standardized) mean of zero and
standard deviation of one. The
significance level, a, is the chance of the
statistical interval of interest not
containing the true value of the number
being estimated, which, in this case, is
the percent of systems where
contaminants of concern on the UCMR
List occur. The true value for the
percentage of systems where
contaminants of concern occur can only
be known if all systems are sampled,
which is not a possibility since Section
1445 (a) (2) (A) requires that only a
representative subset of small systems
be required to monitor for unregulated
contaminants. Using this equation (1),
the matrix below presents the required
sample sizes for several values of
allowable error margins and confidence
levels. For the national representative
sample, an allowable error of ±0.01 at a
confidence level of 99 percent and a
likely proportion of systems with
contaminant occurrence of 1 percent
was chosen. The possibilities for sample
size, confidence level and allowable
error considered in developing this
approach are:
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50578 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
*: SAMPLE SIZES FROM A UNIVERSE OF 65,600 SYSTEMS BASED ON: CONFIDENCE LEVEL
• ;-,! p ,;;;,;; - \ • '_ " ' __ ; , •• t • • '• [, , ;• .„!;,;.. ,;,
Confidence Level (1-a)
90% :.
95%
99% ..... .,..,..!.. '....'.
d, Allowable Error
.03
30
42
73
.02
67
95
165
.01
266
380
659
.005
1,065
1,521
2,636
EPA believes that a representative
sample size of 659 systems to be
sufficient to draw conclusions about
contaminant occurrence for small
systems, based on 99 percent (.99)
confidence level, ± a 1 percent (.01)
allowable margin of error (confidence
interval), and target percent of
contaminant occurrence in 1 percent of
systems; EPA chose a confidence level
of 99 percent because it wanted high
confidence that the true proportion was
included in its sample results. A 5
percent chance that the window of error
did noj include the true proportion was
considered too large, given the amount
of money invested in monitoring and
regulatory decisions. Based on the
monitoring program, a 1 percent risk
(100-§9 percent confidence) that EPA
missed the target was more acceptable.
A small allowable error (narrow
confidence interval), such as ±1 percent
(±0.01), is important for evaluating the
expected low percentages of
contaminant occurrence in systems
because EPA wants to be able to
determine when the monitoring results
show that the percent of systems is
distinguishable from zero or some other
small value close to zero. Determining
this outcome will help EPA decide
which contaminants should receive
primary focus for possible regulation
after the results are evaluated with
health effects data.
To further consider the implications
of the table above, suppose that after
sampling these 659 systems, the
proportion p which equaled or exceeded
a detection level was 4 percent (0.04).
The estimate of the true (unknown)
proportion will be 0.04±0.02, or 4 to 6
percent. This interval has a 99 percent
likelihood of containing the true
proportion of systems having an
occurrence of the contaminant of
concern. There is a 1 percent (0.01)
chance (a) that the true proportion is
outside this estimated interval. A larger
allowable error, d, (e.g., 3 percent)
results in a wider estimate window.
Knowing only that the proportion is
somewhere within a window of 6
percent (e.g., between 1 and 7 percent)
was top large a window of error if the
percent of systems having occurrence of
the UCMR (1999) List contaminants is
less than 3 percent, which may be
possible based on information from
previous unregulated contaminant
monitoring. In such a situation, it will
be difficult to determine whether the
percent of systems with contaminant
occurrence was significantly different
than zero or some small number.
For the purposes of data
interpretation in the future, EPA has
determined that, rather than using the
normal approximation to the binomial
distribution, the Agency should use the
Wilson score interval method
(Newcombe, 1998) which results in a
confidence interval around the estimate
of the percent of systems with
contaminant occurrence which is
narrower on the left or "zero" side of
the estimate and wider on the right side
of the estimate. One advantage to this
interval is that it does not include zero
whenever the estimated exposure is
non-zero.
Additionally, EPA will increase the
representative sample size of CWSs to
721 to increase the statistical power of
the smallest system category. EPA will
also add 79 systems to the NTNCWS
sample size (using the same approach of
applying the percentage of population
served by NTNCWSs in each State to
derive the number of systems allocated
to each State). A total of 800 CWSs and
NTNCWSs are included as the national
representative sample. This allocation
facilitates assigning systems to each
State in the representative sample,
allowing each State to have at least two
systems.
Technical peer review of the
statistical approach found it to be sound
for the purposes of estimating
contaminant occurrence to assess
population exposure to the
contaminants from Assessment
Monitoring. Both internal and external
peer review indicated the possibility of
using another statistical method (such
as the Poisson approximation to the
binomial distribution or Wilson score
interval method) to derive the number
of systems in the national representative
sample and to interpret the data at a
given confidence level and error once
they are reported. Additionally, the
public commenters supported the
statistical approach for deriving and
implementing the national
representative sample of small systems.
The representative sample of 721
small CWSs and 79 NTNCWSs will be
disaggregated to the State level, and
stratified by water source type (ground
water or surface water) and system size
(the three size categories of 25-500,
501-3,300, and 3,301-10,000 persons).
The stratification by State, water source
type and system size is described in the
following example.
Example. To determine the number of
PWSs (CWSs and NTNCWSs) randomly
selected for unregulated contaminant
monitoring as part of the national
representative sample, the following
figures are used as the starting point and
are approximations for the purposes of
example only:
US population: 265,000,000
US population served by small PWSs
serving <, 10,000 persons: 50,000,000
State A's population served by small
PWSs serving 10,000 or fewer persons
equals 1,251,340 persons, which
divided by 50,000,000 persons served
nationally by small water systems
equals 2.5 percent, or the percent of
State A's population served by small
systems of the national population
served by small systems. Multiplying
2.5 percent (0.025) times the 659
systems nationally equals 16.48,
rounded to 16, which is the number of
small systems allocated to State A for its
representative sample. Mathematically,
this can be expressed as:
1,251,340 persons in State A ,,,.„ . , . TT _ .. . _
x659 systems in sample for U.S.= 16 systems in State A s sample
50.000,000 persons in U.S.
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Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations 50579
State A's population served .by small
PWSs supplied by surface water (SW) or
ground water under the direct influence
of surface water (GWUDI) equals
449,920 persons.
State A's population served by small
PWSs supplied by ground water (GW)
equals 801,420 persons.
For each water source type (surface or
ground water), the population served by
small systems is further divided into the
size category. The next step is to divide
the population in each size category by
the population served by small systems
in State A (1,251,340 persons), and then
multiply that result fay the number of
small systems allocated to State A (18
systems), to obtain the number of
systems in that size category for the
water source type that will be in the
State Plan (identified below as "State
Plan Allocation"). For each water source
type, the example results for State A are:
SW/GWUDI SYSTEMS IN STATE A
[Numbers of systems rounded to nearest whole number]
System size (persons served)
10,000-3,301
3,300-501
500-25
Total ,
Population served by size category
.... 281 ,200 persons
154,660 persons
14,060 persons
Number of
persons
served in
state A
— 1 251 340 x
1 251 340 x
1 251 340 x
Systems al-
located to
state A
16
1fi
1fi
State plan
allocation
— 4.
_ 0
n
GW SYSTEMS IN STATE A
[Numbers of systems rounded to nearest whole number]
System size (persons served)
Population served by size category
Number of
persons
served in
state A
Systems al-
located to
state A
State plan
allocation
10,000-3,301
3,300-500 ....
500-25
421,800 persons
239,020 persons
140,600 persons
1,251,340 x
1,251,340 x
1,251,340 x
16
16
16
Total
10 sys-
tems
The total of 6 surface water and 10
ground water systems equals 16
systems, the number to State A's Plan.
The replacement list of systems will
also be developed and provided at this
.level of detail.
Sampling Plan. The sampling plan
that EPA is considering is outlined here.
As shown in the first matrix of
confidence levels, the overall
confidence level is established at 99
percent (0.99). The small water systems
were allocated on the basis of
population served, except in the very
small strata, which EPA supplemented
to bring the statistical inferential ability
up to 95 percent in all cells of the
confidence level matrix.
System Size Category
Very Small (25-500 persons)
Small (501-3,300 persons)
Medium (3,300-10,000 persons)
All System Categories
Desired Confidence Levels by Source Type
Ground Water
0.95
0.95
0.95
0.95
Surface Water
0.95
0.95
0.95
0.95
All Sources
0.95
0.95
0.95
0.99
SAMPLING PLAN
System Size Category
Very Small (25—500 persons)
Small (501—3,300 persons)
Medium (3,300-10,000 persons)
All System Categories Subtotal
NTNCWS Subtotal
Total
Planned national water system allocation by
source type •
Ground water
67
186
189
442
Surface water
64
74
141
279
All sources
131
260
330
721
79
800
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50580 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
Both the very small ground water and
Surface water systems categories
contained too few systems to have a
confidence level of 95, percent. The very
small ground water category needed 6
additional systems and the very small
surface, water category needed 56
systernl to bring them up to the 95
percenf confidence level. These
numbers of systems will be allocated to
each State based on the number of
persons served in each subcategory
within the State. (Note that die example
presented above did not reflect an
additional allocation to the "very small"
strata for surface or ground water
systems for State A. Such an outcome
Would result because State A had a low
number of people in this category
relative to other States and^ would not be
ailocateci an additional system in this
plan.)
EPA has prepared a background
document titled "National
Representative Sample of Small Public
Water Systems: Statistical Design and
State Plans for the Unregulated
Contaminant Monitoring Regulation" to
describe in more detail this selection
process and its relation to the State
Plans. The background document is
available by calling the EPA Safe
Drinking Water Hotline at (800) 426-
4791, or by viewing it on EPA's Internet
Homepage for the Office of Ground
Water and Drinking Water
(www.epa.gov/safewater).
EPA asked for public comment on
whether it should consider using a
targeted approach for selecting systems
in the national representative sample
based on prior knowledge of
contaminant use or occurrence, system
operation or other locational
Information, rather than this stratified
random selection approach. Internal and
external peer reviewers and public
commenters agreed that a targeted
approach would bias the national
results.
Several aspects of potential bias are of
concern to EPA: (1) prior information on
targeted use of a contaminant may not
be perfect which may lead to missing
the target zone; (2) targeting leads to
biased results that would be expected to
have a larger percentage of detections.
potentially overstating occurrence of the
contaminant; (3) targeting areas of
known or expected contaminant use or
occurrence for monitoring does not
provide a representative national
picture of occurrence, because both
detections and nondetections of
contaminants are equally important in
determining national occurrence in the
decision process of whether or not to
regulate a contaminant; and (4) targeting
areas of known or expected use or
occurrence does not take into account
that surface waters can carry the
contaminant out of the targeted area.
The State Monitoring Plans will also
include a representative sample of small
systems that will be combined with a set
of randomly selected large systems for
Screening Survey monitoring of UCMR
(1999) List 2 contaminants. The number
of small systems, selected through the
same statistical process from the
systems used to conduct Assessment
Monitoring, will be smaller (perhaps
150 to 200 systems out of a total number
of about 300 small and large systems)
because the purpose of the Screening
Survey is to test for contaminant
presence in systems rather than testing
for concentrations in an established
percentage (such as 2 or 3 percent) of
systems, as is the case for Assessment
Monitoring. If a contaminant occurs in
a small percent (e.g., 0.5 percent) of
systems, then the contaminant will be
considered to occur at a level that will
indicate that it should be included in
the next round of Assessment
Monitoring.
EPA needs to balance the number of
systems included in the national
representative sample required for
statistical validity with the cost of
paying for the testing. EPA believes that
the final rule's approach balances the
number of systems to be tested with the
cost and also balances a nationally
representative sample with the
allowance for State plans. The final
approach also relieves States from
having to develop the statistical design
and specify the systems to be
monitored.
(b) Systems Selected for Pre-Screen
Testing
If a State enters into an MO A with
EPA, it can participate in the Pre-Screen
Testing program. States must specify
from 5 up to 25 systems as the systems
most vulnerable to the contaminants on
UCMR (1999) List 3. EPA will determine
the number of systems to be selected in
any State based on the population
served by CWSs and NTNCWSs in a
State. The States must modify their
State Plans to identify the small systems
selected for Pre-Screen Testing and
notify the EPA of their addition to those
Plans.
(c) Tribal Water Systems
Public water systems serving less than
10,000 persons that are located on
Tribal lands in Indian country will be
treated as an individual stratum for the
representative sample. The stratified
random selection process described
previously allocates systems within
water source and size category by
population served. A PWS in Indian
country will have the same probability
of being selected as any other water
system in another State based on the
proportion of the population served by
water source and system size category.
Because no State has jurisdiction over
such systems, EPA will consult with the
appropriate tribal government
concerning whether any initially
selected system should be replaced due
to merger, closure, or purchase of water
from another system. The resulting set
of systems will be the "State Plan" for
Indian country.
Public comments relative to Tribal
water systems requested that Tribal
systems be specified through a stratified
random selection process like the other
systems in the national representative
sample to avoid biasing the results. EPA
agrees and plans to identify Tribal
systems through the same stratified
random selection process that is applied
to the other systems.
(d) "Index" Systems
EPA generally has less information
about systems serving 10,000 or fewer
persons than about systems serving
more than 10,000 persons. This lack of
information on these systems and their
operation affects EPA's ability to tailor
regulations to systems of this size. To
provide an improved understanding of
small systems, EPA will select up to 30
small public water systems as "Index"
systems and EPA will conduct
Assessment Monitoring at these systems
during each of the five years for which
the UCMR List and national
representative sample must be
established. EPA is requiring more
frequent monitoring from these systems
than the systems selected for
Assessment Monitoring. Index systems
must be selected from the systems
designated in State Monitoring Plans
using a random number generator. EPA
will pay for this monitoring, including
provision of sample equipment,
shipment of samples, testing, and
reporting. EPA will help Index systems
collect samples by sending a field
technician to each Index system to
obtain the samples. Index system
sampling is being conducted to: ensure
sample collection quality for the 30
systems; provide information of
temporal variation encountered during
the monitoring cycle; and better
understand the needs of small public
water systems in future regulations. The
Index system sampling program is
designed to ensure that future
regulations better reflect the conditions
under which small systems operate.
Owners/operators of Index systems are
required to assist EPA in identifying
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Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations 50581
appropriate sampling locations and
provide information on wells and
intakes in use at the time of sampling,
well casing and screen depth (if known)
for those wells, and the pumping rates
of each well or intake at the time of
sampling. The monitoring results for the
Index systems will be used to
characterize the UCMR results to other
small systems in the national
representative sample with this
frequency and for this additional
information. EPA or its representative
will also collect information on
precipitation, land use and other
environmental factors (e.g., soils and
geology) to provide the Agency with
information on other conditions
potentially affecting drinking water
quality of small systems. This Index
system monitoring will facilitate
extrapolation of Assessment Monitoring
results nationally for systems of this
size. A description of the selection
process for Index systems using a
random number generator will be
presented in the background document,
noted above, titled "National
Representative Sample of Small Public
Water Systems: Statistical Design and
State Plans for the Unregulated
Contaminant Monitoring Regulation."
Public comments received concerning
Index systems were generally
supportive of the approach to provide
additional information to tailor future
regulations to small systems.
(e) Other State Data
Some States may sample and test
additional systems beyond those
included in the State Monitoring Plan.
Any additional systems sampled by
States should not be combined with
those of the State Monitoring Plan for
the purpose of computing national
estimates of contamination. While
providing useful information for
protecting the health of persons using
drinking water from these systems, this
additional data will bias the results of
the national representative sample if
included. However, if the State wants to
report the results of such monitoring,
EPA could receive the data through the
Safe Drinking Water Information System
(SDWIS) for input to the NCOD. EPA
plans to develop acceptance criteria to
allow such data to be placed in the
NCOD. Public comments supported
EPA's position that any data from
additional systems not in the State
Monitoring Plan should not be
combined with data from the
representative sample of small systems
because it would bias the national
results.
G. Reporting of Monitoring Results
Today's final regulation replaces the
reporting requirements at 40 CFR 141.35
to make the reported occurrence results
more useful for sound scientific
analyses.
1. Reporting Requirements (Data
Elements)
UCMR data are one of four types of
data that will potentially be reported to
the NCOD as required by Section
1445(g). The other types of data that
may be included in the NCOD are: (1)
regulated contaminant occurrence data
below the maximum contaminant level
(MCL) but above the minimum reporting
level (MRL) (a regulation may be
developed to obtain this data during
2000); (2) source water monitoring data;
and (3) other data from special studies
and research. Since these data will come
from varying sources, they may have
different reporting requirements. The
PWS data from unregulated
contaminant monitoring may have the
smallest number of data elements to be
reported because of the greater level of
control over the quality of the data
through the laboratory certification
programs and the monitoring and
quality control requirements in the final
rule today.
EPA engaged in an extensive process
of stakeholder and technical review
when developing the NCOD to identify
information reporting requirements that
allow data from different sources to be
adequately evaluated, compared, and
interpreted. The NCOD information
requirements process identified
additional data elements that must be
considered for UCMR reporting with
unregulated contaminant sample test
results. These data elements are
especially important because many of
the contaminants may not be routinely
tested for and will need sample test data
quality indicators to assist in
interpreting the results. These
additional data elements for the
unregulated contaminants, and the
reasons EPA adds them to the previous
reporting requirements in this rule, are
explained briefly in the following table.
EPA requested public comment on these
additional reporting requirements
identified in Table 4, Final Additional
Data Elements for the UCMR. The only
comments EPA received, other than
support for the additional data elements
to be reported, were to clarify Minimum
Reporting Level and Method Detection
Level reporting and their difference
from Instrument Detection Level and
Estimated Detection Level and to use
"presence/absence" for microbiological
contaminants only. A technical peer
reviewer also suggested that spiking
concentration be added to the reporting
requirements to allow evaluation of the
methods being used, since the methods
are still being refined. The reader is
referred to the document titled, "Public
Comment and Response Summary" for
the Unregulated Contaminant
Monitoring Regulation for a discussion
of these comments. The complete list of
data elements for the UCMR appears in
the rule at § 141.35(d), Table 1.
TABLE 4.—FINAL ADDITIONAL DATA ELEMENTS FOR THE UCMR
Final data element
Definition
Reason for reporting
Public Water System Facility Identifica-
tion Number—Source, Treatment Plant
and Sampling Point.
An identification number established by the State,
or, at the State's discretion, the PWS, that is
unique to the system for an intake for each
source of water, a treatment plant and a sam-
pling point. Within each PWS, each intake,
treatment plant and sampling point must re-
ceive a unique identification number, including,
for intake; surface water intake, ground water
well or wellfield centroid; and including, for
sampling point; entry points to the distribution
system, wellhead (or wellfield), intake, or loca-
tions within the distribution system. The same
identification number must be used consistently
throughout the history of unregulated contami-
nant monitoring to represent the facility.
Identify source water, treatment plant and sam-
pling location for use in evaluating contaminant
source controls in regulation development. The
source intake/well identification number can be
related to latitude and longitude for use in geo-
graphic analysis of land use, soils, geology and
precipitation for alternative treatment and con-
trol analysis. Treatment plant identification
number can be related to treatment information
for that plant to use in analysis of alternative
treatments. Sampling point identification num-
ber will allow the sample test result to be con-
sistently associated with the same sample lo-
cation over time for trend analysis.
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50582 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
TABLE 4.—FINAL ADDITIONAL DATA ELEMENTS FOR THE UCMR—Continued
Rnal data element
Definition
Reason for reporting
Sample Analysis Type
Detection Level
Detection Level Unit of Measure
Batch Identification Number
Spiking Concentration,
Analytical Precision
Analytical Accuracy.
Presence/Absence
The type of sample collected. Permitted values
include: (a) Reid Sample—sample collected
and submitted for analysis under this rule, (b)
Batch Spike/Spike Duplicate Samples—Sam-
ples associated with a batch for calculating an-
alytical precision and accuracy. A batch is a
collection of 22 samples analyzed together, of
which two are the spike and spike duplicate
samples, that are tested for analyte concentra-
tions.
"Detection level" refers to the detection limit ap-
plied to both the method and equipment. De-
tection limits are the lowest concentration of a
target contaminant that a given method or
piece of equipment can reliably ascertain and
report as greater than zero (i.e., Instrument
Detection Limit, Method Detection Limit, Esti-
mated Detection Limit).
The unit of measure to express the concentra-
tion, count, or other value of a contaminant
level for the detection level reported.
(e.g., ug/L, colony forming units/mL (CFU/mL),
etc.).
A unique number assigned by the laboratory ana-
lyzing samples to a specific batch of samples.
The number comprises 9 digits for the labora-
tory identification number, 4 digits for the year,
2 digits for the month, 2 digits for the day, and
2 digits for the batch of samples.
The concentration of method analytes added to a
sample to be analyzed for calculating analytical
precision and accuracy.
For purposes of the UCMR, Analytical Precision
is defined as the relative percent difference
(RPD) between spiked matrix duplicates. The
RPD for the spiked matrix duplicates analyzed
in the same batch of samples as the analytical
result being reported is to be entered in this
field. Precision is calculated as RPD between
spiked matrix duplicates using, RPD =
[(Xi -X2) / {(Xi + X2)/2}] x 100.
For the purposes of the UCMR, accuracy is de-
fined as the percent recovery of the contami-
nant in the spiked matrix sample analyzed in
the same analytical batch as the sample result
being reported and calculated using;.
% recovery = [(amt. found in Spiked sample—
amt. found in sample) / amt. spiked] x 100.
Chemicals: Presence—a response was produced
by the analysis (i.e., greater than or equal to
the MDL but less than the MRL)/Absence—no
response was produced by the analysis (i.e.,
less than the MDL).
Micmbiologicals: Presence—indicates a response
was produced by the analysis/Absence—indi-
cates no response was produced by the anal-
ysis.
Indicates field and spiked sample to ensure that
the sample test result is used for the appro-
priate analysis (e.g., contaminant concentration
trends, sample test performance, etc.).
Indicates lowest quantifiable measurement level
applied through the method to the sample to
allow comparison with other sample test re-
sults.
Indicates the reporting unit for the detection limit.
Allows calculation and comparison of precision
and accuracy among batches of samples and
association of precision and accuracy with
each sample in a batch to sort results based
on data quality.
Allows calculation of precision and accuracy for a
batch of samples and an evaluation of the
method.
Indicates variability among laboratory results as
measured by testing replicate field or duplicate
spiked samples, and is a key measure of sam-
ple test performance.
Indicates whether test results are within a group
of measurements corresponding to the true
value of the results, and is a key measure of
sample test performance.
Chemicals: Indicates results that do not have a
quantifiable value and whether, for a positive
result, the chemical concentration is between
the MRL and the MDL to allow more thorough
assessment of the method's capability to iden-
tify the contaminant.
Microbiologicals: Allows measure under condi-
tions and for microorganisms that are not able
to be counted.
Note that EPA deleted "composite"
from the proposed set of data elements
since the final rule does not allow
compositing. Since this program is
designed to measure actual occurrence
of contaminants, compositing (the
combining of samples from several
sampling points of a water system) will
dilute concentrations of cpntaminants to
be measured. Stakeholders supported
the deletion of compositing, and
believed it to be contrary to the
objectives of the UCMR. No public
comments were received on this subject.
Also note that "Public Water System
Facility Source Intake Identification
Number" must currently'be reported
under existing reporting requirements
for SDWIS under 40 CFR 142.15(b)(l). '
The UCMR will expand this
requirement to include the unique
identification numbers for treatment
plant and sampling point, which may
not change over time. EPA is not
requiring, through today's action, the
reporting of treatment data (treatment
objectives and processes) since these
data are already required to be reported
by January 1, 2000, for all systems. (Safe
Drinking Water Information System
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Federal Register/Vol. 64. No. ISO/Friday, September 17, 1999/Rules and Regulations 50583
FACT SHEET, Revised Inventory
Reporting Requirements, June 1998)
The rationale for including these data
elements is that EPA needs the detailed
information concerning the sample test,
location, and treatment that will allow
the results to be used in making a
determination of whether or not to
regulate the contaminant and to develop
regulations. The specific reasons are
identified in Table 4. To avoid duplicate
and costly resampling efforts, EPA
believes that systems should obtain and
report the most complete information
the first time a sample is tested.
The information requirements process
for development of the NCOD identified
technical questions that need to be
answered in the regulatory process that
the UCMR is to support. These data
elements are associated with these
questions. While the list of data
elements will increase by five (from 12
to 17) in today's final UCMR (as
compared to the existing UCMR),
reporting them the first time precludes
the need to obtain the information
through another process. Because the
1996 SDWA Amendments expanded the
determinations and types of analyses
that need to be conducted to develop a
rule, including these data elements is
responsive to the new regulatory
environment in which drinking water
regulations must be developed.
These new data elements will not be
a major burden for a PWS. Only four of
the elements must be supplied by the
PWS: the PWS ID; the Facility ID; the
sample number; and sample collection
date. All other elements can be supplied
by the laboratory.
States commented that EPA should
not require system inventory data if
those data are required under another
reporting arrangement in 40 CFR
142.15(b)(l). As a result, EPA modified
this final rule eliminating inventory
data elements that are required for other
reporting. Today's rule requires that
.Public Water System Facility ID be
reported. Coupled with the PWS ID, the
facility ID can be linked to sampling site
information and locational data
necessary for thorough analyses of the
data.
As explained earlier, EPA also
requires owners/operators of Index
systems that are part of State Plans for
the national representative sample to
provide data concerning well casing,
screen depths and pumping rates at
each well or intake at the time of
monitoring. This reporting will allow
EPA to tailor regulations to systems
serving 10,000 or fewer persons by
relating sample test results to conditions
that affect capture of contaminants by
ground water and surface water
supplied systems.
2. Reporting to the Primacy Agency
Today's rule changes reporting
relationships for unregulated
contaminant monitoring data. The
statute requires that the results be
reported to the primary enforcement (or
"primacy") authority for the system.
Many States and systems raised
questions about the necessity and utility
of requiring State primacy for the
UCMR. In response to these comments,
EPA has decided to directly implement
the UCMR, while allowing States to
participate in State Plan review and
implementation through MOAs rather
than through State primacy. Some States
noted that UCMR data will primarily be
used by EPA to make regulatory
determinations, and that such data are
not required by the State to assess
compliance for public health. The States
however, need these data for their
program records and implementation. In
response to these comments, EPA is not
requiring the State to report the data,
but is requiring the PWS to report the
data electronically to EPA, unless
otherwise arranged, with a copy to the
State. EPA will issue guidance on the
process of reporting to EPA
electronically or in other formats and
providing a copy of the results to the
State. Since EPA is paying for small
systems' testing and reporting, the
Agency will set up an electronic
reporting system for these systems that
are required to report. EPA will report
the data to the States for these small
systems. EPA will hold the data of small
and large systems for 60 days to allow
systems and States to review the data
before placing the data in the NCOD, as
required by SDWA. EPA encourages
States to review the data as time allows
because their review is critical to
identifying drinking water quality issues
that may not be obvious at the national
level. This review provides an
additional level of data quality control
before EPA uses the data in regulatory
decisions.
3. Timing of Reporting
In response to public comments from
States and systems requesting more time
to report these data, EPA modified the
rule at § 141.35(c) to require large PWSs
to report their monitoring results within
thirty days, rather than ten days, after
the month in which they receive the
results from the laboratory. This
requirement provides additional time
for systems to review the UCMR results
before reporting them to EPA.
4. Method of Reporting
SDWA Section 1445 (a)(2)(D) states
that each PWS that monitors for
unregulated contaminants must provide
the monitoring results to the primacy
authority for the system. Today's final
rule requires electronic reporting by
PWSs to EPA, while providing a copy of
the results to the State (§ 141.35(e)). The
rule also allows EPA to specify another
method for reporting by a PWS, if
necessary. Public commenters
supported allowing an alternate
reporting method for PWSs if they could
not report electronically. Note that EPA
will pay for the testing and laboratory
analysis of samples for small systems in
State Monitoring Plans. Since EPA plans
to establish electronic recordkeeping of
the results from systems in State Plans,
electronic reporting for these systems
will be done through the assistance of
EPA. EPA might consider specifying
another method for reporting when a
system serving over 10,000 persons has
not developed the capability to report
electronic results. However, most
laboratories have this capability and
could probably provide this service for
the PWS.
5. Public Notification of Availability of
Results
SDWA Section 1445 (a)(2)(E) requires
notification of the results of the UCMR
program to be made available to persons
served by the system. The results of
UCMR monitoring for CWSs will be
reported through annual Consumer
Confidence Reports (CCR), as required
by § 141.153 (d). For NTNCWSs, UCMR
monitoring results will be reported
according to requirements of the revised
public notification rule as proposed
May 13, 1999 at-64 FR 25963. Failure to
monitor for unregulated contaminants
required through the UCMR will also be
reportable under the public notification
rule.
The results that will be reported
through the CCR and public notification
rules should be based on the same
monitoring data that the States will
receive under the UCMR and will be
required to be reported to the NCOD.
Information in the NCOD will be
available to the public.
VIL Section-by-Section Analysis of
Public Comment and EPA Response
This portion of the preamble is
devoted to highlighting major changes
in the specific sections and paragraphs
of the revisions to the Unregulated
Contaminant Monitoring Regulation,
including 40 CFR 141.35, 141.40,
142.15(c), and 142.16, in the order that
they appear in the Code of Federal
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, ','• •• ill, <;*l " • , • . ' ' • - ", : , .' .'*.• ' ••;", ,i{liti '. v „ ! . " ,,:.,,'
50584 Federal Register/Vol. 64, No. 180/Friday, September 17, 1999/Rules and Regulations
i i
Regulations and are promulgated here as
ft fijial rule today. The details of the peer
rfeview and public comments and EPA's
responses can be found in two
background documents: External Peer
Reviews of the Unregulated
Contaminant Monitoring Regulation,
and Public Comment and Response
Summary for the Unregulated
Contaminant Monitoring Regulation.
A. Section 141.35—Reporting of
Unregulated Contaminant Monitoring
Results
1. Does this reporting apply to me?
This paragraph notes that § 141.35
applies to the owner or operator of any
PWS required to monitor for
unregulated contaminants under
§ 141.40. Exceptions to the reporting
requirements are also noted. The
majority of comments received on this
topic suggested that water systems using
purchased water should be required to
monitor for contaminants occurring in
distribution lines, such as
microbiological contaminants. Like the
proposed rule, today's final rule states
that small systems serving 10,000 or
fewer persons need not report their
results to EPA because EPA will pay
and arrange for testing and reporting of
the results. To improve the logical flow
of the rule, EPA moved this exception
io this paragraph from the paragraph
Immediately below it.
In response to these comments, EPA
has modified this section, noting that
water systems that purchase all of their
water will be included in the UCMR for
contaminants haying distribution
System sampling points, including
points of maximum residence time or
points of lowest disinfectant residual.
A few commenters suggested it was
Inappropriate for only the small systems
selected as part of the national
representative sample to report UCMR
results and not other small systems. In
response, EPA notes that Section
1445(a) (2) (D) of the SDWA states that all
systems required to conduct
unregulated contaminant monitoring
must report the results. Because only a
nationally representative sample of
small systems will be required to
monitor under the UCMR, only those
systems will have to report the results.
2. To whom must I report?
This section explains the reporting
requirements for systems that will
monitor for unregulated contaminants.
Underjx>day's rule, a system must
report the results of unregulated
contaminant monitoring to EPA and
provide a copy to the State. This is a
change from the proposal and is based
on EPA's decision, in response to public
comment, to implement this rule
through MOAs with State agencies
rather than through the primacy
process. EPA will hold the data for 60
days to allow systems and States time to
conduct a quality control review before
entering the data into the NCOD. This
is discussed in more detail in IX.A.
Implementation of the Rule. The system
also must notify the public of the
monitoring results as provided in
Subpart O (Consumer Confidence
Reports) and proposed Subpart Q
(Public Notification) of this part.
Even though small systems do not
report their results because EPA will do
that for them, small systems must still
comply with the public notification
requirements for these results.
3. When do I report monitoring results?
This section specifies that a PWS
must report the results of unregulated
contaminant monitoring within thirty
days following the month in which they
receive the results from the laboratory.
Today's final rule is slightly different
from that of the proposed rule. Rather
than reporting within 10 days of
receiving monitoring results, it extends
the deadline for reporting results to
thirty days after the month in which the
results are received from the laboratory.
This change provides more time for the
system to review the data before
reporting. This is in response to
comments received indicating that the
requirement that systems report results
within 10 days after receiving results
from the laboratory is too short a period.
Additionally, commenters were
concerned with adequate time to review
and understand the data before
reporting them to EPA. Also, as noted
previously, EPA will wait 60 days
before placing the data in the National
Drinking Water Contaminant
Occurrence Database (NCOD) to allow
additional time for systems, States and
EPA to ensure quality control of the
data.
Consistent with the decision to not
require States to adopt this rule as part
of primacy, EPA has also clarified that
EPA, not the State primacy agency, will
specify the required monitoring period.
A commenter was concerned with the
costs associated with reporting UCMR
results quarterly and requested that
PWSs be allowed to report data in an
annual batch. EPA is maintaining the
requirement of quarterly reporting
because EPA does not believe that
annual reporting would allow EPA to
use the data as input to the next round
of the CCL and UCMR lists, which is a
principal objective of the rule. Also,
large PWSs already report quarterly.
Additionally, EPA plans to evaluate the
data early to determine whether
modifications are needed in the
analytical methods.
4. What information must I report?
This section lists and defines the data
elements that must be reported. In
addition to analytical results and quality
control, EPA is requiring information on
the PWS from which the analyzed
sample was taken.
Today's rule modifies somewhat the
unregulated contaminant monitoring
reporting requirements in the proposed
rule (Table 8 of "Revisions to the
Unregulated Contaminant Monitoring
Regulation for Public Water Systems,"
Federal Register, vol. 64, no. 83, April
30, 1999, pages 23426 to 23428) and
reorders the sample data elements. For
example, for microbiological
monitoring, future requirements may
specify either a sampling point in the
distribution system that has the
maximum residence time or, under
today's rule, the lowest disinfectant
residual, in response to comments
concerning systems using disinfectant
booster stations where the disinfectant
residual is low. These sampling point
types were added to the data element
listing.. Questions were raised as to how
the UCMR would accommodate water
systems that have mixed sources (i.e.,
use blended/mixed surface water and
ground water). In response, the data
element. Water Source Type, will be
modified in the Safe Drinking Water
Information System (SDWIS) Inventory
Reporting Requirements to address this
issue: the valid choices for this data
element will include purchased/non-
purchased blended/mixed water. See 40
CFR 141.35(d) Table 1 of the rule for
more information.
Sample collection date must be
reported as 4-digit year, 2-digit month,
and 2-digit day under the final rule to
ensure year 2000 compliance, and to
refine date records, as suggested by peer
reviewers. Also added to the sample
data elements is a sample batch
identification number, which is
assigned by the laboratory to each batch
of samples analyzed with the spike and
spike duplicate sample at the spiking
concentration to allow analysis of
method performance. The list of
permitted sample analysis types is
reduced to field sample and batch
spike/spike duplicate since these will be
the only required sample types reported
for unregulated contaminant
monitoring.
During the public comment period, a
comment was received suggesting that
inventory data elements should be
provided officially by the States through
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Federal Register/Vol. 64. No. ISO/Friday. September 17, 1999/Rules and Regulations 50583
the inventory data reporting process,
rather than by systems with their
sample results. EPA agrees that
inventory data elements are already
reported by a different mechanism.
Therefore, EPA has removed the data
elements that are or will be included in
the Safe Drinking Water Information
System (SDWIS) Inventory Reporting
Requirements: sampling point type,
water source type, public water system
facility type, latitude of the public water
system facility for source and treatment
plant, and longitude of the public water
system facility for source and treatment
plant. This change in data elements
under today's rule provides for the
revision or addition in inventory data
reporting for the data elements not
included in the rule to address:
(A) for sampling point type, an
expansion of allowable choices to
include: raw/untreated water, finished
water from treatment system, finished/
treated water from entry point to the
distribution system after treatment,
finished/treated water from within the
distribution system, finished/treated
water from the distribution system at
the location of maximum residence time
or lowest disinfectant residual, finished/
treated water from the distribution
system at the location of lowest
disinfectant residual, finished/treated
water from household/drinking water
tap, finished/treated water from
unknown location, and other finished/
treated water;
(B) for water source type, to include
allowable choices of: surface water from
a stream or purchased surface water
from a stream, surface water from a lake
or reservoir, or purchased surface water
from a lake or reservoir, ground water
under the direct influence of surface
water or purchased ground water under
the direct influence of surface water,
ground water or purchased ground
water, and blended/mixed surface water
and ground water, or purchased
blended/mixed surface water and
ground water;
(C) for public water system facility
type, to include, for the purposes of
UCMR, the allowable choices of: intake
(for surface water sources), well or
wellfield (for ground water sources),
treatment plant, sampling point, entry
point to distribution system, reservoir,
booster station, and unknown;
(D) latitude of the public water system
facility for source and treatment plant;
and
(E) longitude of the public water
system facility for source and treatment
plant. Additionally, the SDWIS
inventory reporting requirements will
address associating the PWS facility
identification number of any sampling
point with the PWS facility
identification number of its respective
treatment plant. Furthermore, the reason
that the latitude and longitude of the
treatment plant should be reported is to
allow the association of other data, such
as health effects information, with a
point closest to the affected population,
since the ultimate use of the UCMR data
is for input to exposure assessment in
determining whether or not to regulate
a contaminant.
Comments were received suggesting
that EPA include the maximum
reporting level (MRL) in the data
elements. It is not necessary to include
the MRL in the data elements because
the MRL is specified in the rule in
§ 141.40(a)(3) Table 1. The rule wording
is clarified so that a particular
laboratory having the capability for
reliable lower detection may report
concentrations below the MRL.
Some commenters had concerns about
the inclusion of a presence/absence data
element. For microbiological
contaminants, this data element may be
needed because analytical methods do
not always allow for quantification of
the target organism in the sample and
may only allow for a qualitative
response, i.e., presence or absence. For
chemical contaminants it can be used
for reporting the detection of chemical
contaminants below the MRL but above
the MDL.
5. How must I report this information?
This section explains that the
unregulated contaminant monitoring
results must be reported in electronic or
in another format specified by EPA,
such as a template on paper that can be
scanned and entered into the NCOD
electronically.
A question was raised as to how EPA
will be able to accept electronic data
from diverse laboratory information
systems at the many laboratories that
may be reporting data. It was also
suggested that EPA work with States
and water suppliers to develop formats
to make electronic submission easier.
EPA is considering the development of
software that may be downloaded from
the EPA website to enable systems and
their laboratories to electronically report
data. This may be the same electronic
data form that allows PWSs to report
data to NCOD/SDWIS.
Some commenters indicated that the
State should have the option to specify
an alternate reporting method,
particularly with respect to small
systems. It was also suggested that EPA
should write the rule so as not to
preclude reporting directly to States and
EPA from the laboratories for small
systems, as well as for large systems.
The laboratory, whether EPA-approved
or an EPA-designated (i.e., contract)
laboratory, could report to systems,
States, and EPA. As noted previously,
EPA will report the data for small
systems.
As noted, the final rule is modified to
require systems to report to EPA. EPA
will require electronic reporting, unless
some other format must be used for a
particular system. This situation may be
established in consultation with the
State and described in subsequent
guidance that EPA will prepare on the
UCMR reporting process.
One commenter also expressed the
need for an electronic legal equivalency
of a signed hard copy of a laboratory
report. Since there is no requirement for
electronic reporting of a signed
laboratory report, EPA will not require
an electronic legal equivalency. Systems
may want a signed hard copy for their .
own records.
6. Can the laboratory to which I send
samples report the results for me?
This section states that a laboratory
can report the sample results, so long as
it provides the system with a copy for
review and record keeping.
The Agency was asked to clarify that
it is the responsibility of the PWS
owner/operator to report data to EPA,
even if the laboratory reports the results.
In response to comments, the rule
wording has been clarified to stress that
the PWS is responsible for reporting
information and ensuring that the
laboratory provides the results to EPA
and the State.
7. Can I report previously collected data
to meet the testing and reporting
requirements for the contaminants in
§141.40(a)(3)?
This paragraph was added in response
to many comments received requesting
a provision for systems to report
relevant unregulated contaminant data
collected before implementation of
today's rule, in lieu of allowing only
UCMR data collected after the rule's
effective date. The general consensus
was that some large systems may
already have monitored for or want to
monitor before 2001 for these
contaminants, especially if it fits within
their monitoring cycle. This paragraph
specifies that, as long as systems meet
the requirements specified in
§ 141.40(a)(3), (4), (5) and Appendix A
for monitoring and in § 141.35 (d) for
reporting, the data collected before the
effective date of this rule can be
submitted to meet the testing and
reporting requirements for the
contaminants in § 141.40(a)(3).
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50586 federal Register/Vol. 64, No. 180/Friday, September 17, 1999/Rules and Regulations
B. Section 141.40—Monitoring
.Requirements for Unregulated
Contaminants
1. Requirements for Owners and
Operators of Public Water Systems
(a) Do I have to monitor for unregulated
contaminants?
This section eliminates unregulated
contaminant monitoring requirements
for owners and operators of transient,
non-community water systems. It also
specifies the monitoring requirements
for large systems that do and do not
purchase their entire water supply from
another system and for small systems
selected for the program that do and do
not purchase their entire water supply
from other systems.
Today's rule describes specific
monitoring requirements for large and
small systems that purchase their entire
water Supply from other systems. This
is in response to the many commenters
who indicated that PWSs using
purchased water should be included in
the UCMJR for microbiological
contaminants, or other- contaminants
that may arise in the distribution
system. As a result, EPA modified the
rule to require that water systems that
purchase all of their water will be
included in the UCMR for contaminants
having distribution system sampling
points.
(b) How would I be selected for the
monitoring under the State Monitoring
Plan, the screening survey, or the pre-
screen testing?
This section is basically unchanged
from the proposed rule since
commenters broadly supported the 3-
tier approach to the monitoring
program. It explains that only a
representative sample of small systems,
randomly selected by EPA. will be
required to conduct assessment
monitoring for unregulated
contaminants as part of a State
Monitoring Plan. A subset of these
systems will be randomly selected as
Index systems and required to submit
additional information. Each State will
have the opportunity to modify the list
of selected systems.
(c) For which contaminants must I
monitor?
The Unregulated Contaminant
Monitoring List is presented in this
section. It comprises List 1, the
chemical contaminants to be monitored
under Assessment Monitoring; List 2,
the chemical and microbiological
contaminants to be monitored under the
Screening Survey; and List 3, the
chemical and microbiological
contaminants to be monitored under
Pre-Screen Testing.
In response to many comments,
today's rule makes changes in the
contaminant lists as presented in the
proposed rule. For List 1, the chemicals
perchlorate and acetochlor are added
and the microbiological contaminant
Aeromonas is removed and moved to
List 2. The analytical methods for
perchlorate and acetochlor are reserved.
The methods are expected to be ready
in the near future, at which time, a rule
revision will be published for comment
and promulgated to ensure these
contaminants can be monitored on or
before January 2001. Nitrobenzene, also
on List 1, has an approved method, but
it requires careful implementation.
Acetochlor (now on List 1) is removed
from List 2, and RDX and the
radionuclide polonium-210 are added to
List 2. The sampling locations for List
1 and 2 contaminants are Entry Points
to the Distribution System (EPTDS),
except for Aeromonas and polonium-
210, for which the sampling points are
reserved until the methods are further
validated and promulgated. The
radionuclide lead-210 is added to List 3.
Sampling locations for the
radionuclides and microogranisms are
reserved, as are the dates for the period
during which monitoring must be
completed. These dates will be
determined at a later time. To activate
monitoring for the contaminants on
Lists 2 and 3, the methods and related
sampling requirements must be
specified in future rulemaking revising
this regulation.
Many commenters indicated that it
would be premature to include
Aeromonas on List 1 since the specified
method has not been sufficiently field
tested. It was also suggested that the
rule should be clear about its focus on
Aeromonas the genus, not the species A.
hydrophila.
In response, EPA has moved
Aeromonas to List 2. The CCL specifies
Aeromonas hydrophila; however, the
proposed analytical method identifies to
the level of the Aeromonas hydrophila
complex, which is a group of about 7 to
12 Aeromonas species. To identify to
the species level would increase the cost
and complexity of the analysis and,
given funding considerations, would
limit the size of the Aeromonas
monitoring program that could be done.
Given the cost of the analyses and how
frequently Aeromonas has been found
in previous finished water surveys, a
panel of EPA scientists'(CCL
Microbiology Meeting, Cincinnati, OH,
July 9, 1998) agreed that identifying to
the Aeromonas hydrophila complex
(rather than the species) level was
adequate for the purpose of the UCMR.
A final method has not yet been written
for Aeromonas. The current draft
analytical method for Aeromonas, draft
EPA Method 1602, does not include
verification tests since a final decision
on the inclusion of verification tests into
the method will be made after method
validation studies. Since the method
validation studies have not been
completed, EPA has placed Aeromonas
on List 2, to be monitored after the
method is ready.
In response to over 100 public
comments and peer review
considerations addressing the inclusion
of perchlorate in the UCMR, EPA has
added it to List 1. EPA did not originally
propose monitoring for perchlorate
under this portion of the regulation
based on three general concerns: its
apparent local/regional, rather than
nationwide, occurrence at the time EPA
assembled the monitoring list; current
analytical methods do not adequately
address potential interferences from
chloride, sulfate or other dissolved
solids; and no laboratories are certified
for performing analyses using the
methods for perchlorate. Based on many
comments that showed perchlorate
occurrence in many locations around
the nation, EPA placed perchlorate on
List 1. The analytical method for
perchlorate is listed as "reserved" in the
UCMR pending imminent conclusion of
EPA refinement and review of the
analytical method. Since EPA did not
initially include a perchlorate analytical
method in the proposal to this
regulation, it will be necessary for EPA
to issue an additional regulation to
formally propose and promulgate a
perchlorate analytical method prior to
initiating monitoring for perchlorate
under the UCMR.
Therefore, following promulgation of
the UCMR (including the "reserved"
perchlorate method reference), EPA will
be proposing a new regulation
specifying both the approved analytical
method for the analyses of perchlorate,
and the implementation of a laboratory
approval system, where labs are
certified to test for perchlorate. EPA is
currently conducting analytical methods
development to support the analyses of
perchlorate. This new method will be
based on the currently available ion
chromatpgraphy methods, but will
include a criteria detailing when a
laboratory must perform a sample clean-
up procedure to minimize the impact of
elevated concentrations of chloride,
sulfate or other dissolved solids. The
laboratory approval system will be
based upon previous certification of the
laboratory for the analyses of
compliance monitoring samples using
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Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations 50587
either EPA Method 300.0 or 300.1, and
the successful analyses of a perchlorate
performance evaluation sample.
EPA asked for comment on and a few
commenters recommended the addition
of RDX (hexahydro-1,3,5-trinitro-1,3,5-
triazine) to the UCMR. In response, EPA
has placed RDX on List 2, as its method
needs further refinement. EPA will
propose and promulgate an analytical
method for RDX prior to requiring
monitoring for RDX under the UCMR.
EPA also received comments
suggesting that it move acetochlor, 2,4-
dichlorophenol and 2,4,6-
trichlorophenol from List 2 to List 1,
and require systems to use EPA Method
525.2 to analyze for acetochlor and
either a new SPE/GC/MS method
modified for EPA Method 525.2 or a
modified EPA Method 552 to analyze
for the phenols. EPA has moved
acetochlor to List 1, since the analysis
of acetochlor using EPA Method 525.2
is expected to be approved prior to
UCMR implementation. The evaluation
of the use of EPA Method 525.2 will be
finalized after acetochlor preservation
studies have been completed. EPA will
propose and promulgate an analytical
method, likely EPA Method 525.2, for
acetochlor prior to requiring monitoring
for acetochlor under the UCMR.
EPA did not move 2,4-dichlorophenol
and 2,4,6-trichlorophenol to List 1 since
the progress of method development for
these contaminants is not equivalent to
that of acetochlor. EPA has. determined
that the phenols are not compatible with
EPA Method 525.2 and expects to
require a separate SPE/GC/MS method
currently under development. A
modification to EPA Method 552 was
also suggested. The suggested
diazomethane modification to EPA
Method 552 is not an option permitted
in Method 552 as an EPA approved
method and must be evaluated,
reviewed and approved before allowing
it to be used as an EPA method.
As noted in this comment,
dichlorophenol and 2,4,6-
trichlorophenol can only be analyzed
using method 552, when the
diazomethane used is sufficiently
strong. This does not lead to the type of
reproducibility needed to approve this
method in a variety of analytical
laboratories that may produce
diazomethane of varying strengths. If
the diazomethane is not as strong as that
indicated in this comment, the recovery
of dichlorophenol can drop to 10%. In
addition, 2,4,6-trichlorophenol is
subject to interferences caused by the
derivatization product of 2,4-
dichlorophenol, regardless of the
strength of the diazomethane. Method
552 is not approved for the analyses of
any other UCMR analytes. Therefore,
use of Method 552 for these 2
compounds would then require the
laboratory to use a separate method for
the analyses of the other phenols
included in the UCMR. Instead of
requiring 2 methods for these analyses,
EPA is currently conducting the method
development necessary to provide a
solid phase extraction GC/MS method,
that does not require derivatization, for
the analyses of all of the phenols
included in the UCMR as well as other
phenols not currently listed. This will
provide a single solid phase extraction,
GC/MS method for the analyses of aU of
the phenols included in the UCMR.
Therefore, 2,4-dichlorophenol and 2,4,6-
trichlorophenol will remain on List 2.
As suggested by several commenters,
EPA has added polonium-210 and lead-
210 to the UCMR Lists. New
information indicates that methods for
these contaminants may be easier to
conduct than originally envisioned.
However, EPA research and an external
expert reviewer with experience with
radionuclides note that the currently
available methods for lead-210 and
polonium-210 may be very time
consuming and will require an
experienced analyst. There are also
significant laboratory capacity and
capability concerns. Few, if any,
laboratories currently performing
compliance drinking water
radiochemistry have any experience
with polonium-210 or particularly lead-
210. The method for lead-210, in
particular, needs further refinement.
Therefore, EPA has added polonium-
210 to List 2 and lead-210 to List 3.
Before requiring monitoring for these
contaminants, EPA will need to address
issues related to radionuclide laboratory
capacity and certification.
The recommendation was also made
that the Agency add EPA Method 502.2
for the measurement of MTBE. Several
public comments suggested that EPA
Method 502.2 was reliable, and that if
it is not added, then there could be
added burden on PWSs using GC
methods. EPA considered the
commenters concerns; however, the
Agency is not allowing the use of EPA
Method 502.2 for MTBE. MTBE is not
included in EPA Method 502.2 because
MTBE cannot be reliably measured by
either of the detectors used in the
method, and its stability has not been
tested using the preservatives listed in
that method.
Some commenters also suggested the
use of EPA 525.2 for nitrobenzene since
they have problems using the methods
listed in this regulation. Nitrobenzene
will remain on List 1 with EPA Method
524.2, and voluntary consensus
standard methods D5790-95 and
SM6210D being approved for its
analysis. However, the commenters are
correct that some laboratories have had
problems measuring nitrobenzene using
these methods. When laboratories do
not use the three stage trap listed in the
method, nitrobenzene cannot be
detected at reasonable concentrations in
either standards or samples. Since they
will therefore clearly fail the quality
control requirements of the method,
data will only be generated by
laboratories that can provide useful data
based on full method implementation.
While the data provided by a
commenter and confirmed by current
EPA methods development research
demonstrate that nitrobenzene can be
analyzed using EPA Method 525.2, the
preservation of nitrobenzene using
Method 525.2 conditions has not been
demonstrated. The methods
development research .needed to
determine that nitrobenzene can be
preserved using the sampling
procedures specified in EPA Method
525.2 is currently being conducted. If
nitrobenzene is compatible with this
method's preservation requirements,
then EPA will propose and promulgate
an analytical method for nitrobenzene
prior to requiring monitoring for
nitrobenzene.
As for the use of EPA Method 525.2
for the analyses of nitrobenzene,
research recently conducted in the
OGWDW laboratory clearly indicated
that nitrobenzene cannot be accurately
analyzed using Method 525.2.
Recoveries of nitrobenzene were less
then 10% when samples were extracted
using the conditions specified in
method 525.2. In conversations with the
laboratory submitting this comment,
EPA was informed that the data
submitted in this comment was not
developed using the procedures
specified in EPA Method 525.2. In
addition, no analyte stability data is
available for the storage of nitrobenzene
in samples preserved as specified in
method 525.2 or in extracts generated
using method 525.2. Therefore, EPA
Method 525.2 will not be approved for
the analyses of nitrobenzene.
One commenter suggested that EPA
Method 632 is a simple method with
adequate sensitivity for measuring
diuron and linuron. EPA Method 632 is
a modification of the National Pesticide
Survey Method 4, which EPA has found
is not reliable for diuron and linuron.
One commenter requested that an
HPLC method that can measure each of
the two DCPA acid degradates
separately be approved for their
analyses. However, this method was
published in a journal not by EPA or
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50588 Federal Reg*ster/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
any of the consensus methods
organizations. This method, to the best
of EPA's knowledge, is only being used
in a limited number of laboratories and
therefore has not had the level of
validation necessary for use in this type
of occurrence data gathering effort. In
addition, since the methods that were
approved measure the two DCPA
degradates as a single analyte,
approving a method that measures them
differently would cause concern about
data reporting and interpretation.
(d) What general monitoring
requirements must I follow for List 1
monitoring?
This section specifies what is
generally required of all systems
participating in Assessment Monitoring.
It also details additional monitoring
Requirements unique to large and to
small systems.
Several commenters expressed
support for collecting routine water
quality parameters (WQPs) and agreed
that WQPs provide useful information
and a solid framework within which to
explain and understand monitoring
results, especially for microbiological
contamlpants. Several did not believe
that reporting or testing of WQPs is
necessary, noting that WQPs are not
routinely collected for all systems, and
expressing particular concern that small
ground water systems without treatment
do not collect information on chlorine
residuals.
Water quality parameters are
important for microbiological
contaminants and may affect
degradation of chemical contaminants.
However, EPA is limiting the set of
additional parameters, in response to
comments. EPA is requiring reporting of
additional parameters, as appropriate to
the contaminant type, including pH,
turbidity, temperature, and free and
total disinfectant residuals. In addition,
today's rule specifies the contaminant
type and EPA Method, Standard
Method, or other voluntary consensus
standard that may be used to measure
these parameters. Small ground water
systems that do not disinfect would
have no residuals to measure or report,
so this will not be a burden.
Furthermore, for small systems serving
lO.OuO or fewer persons, EPA will pay
for the testing of these water quality
parameters as part of the testing
program for unregulated contaminants.
The monitoring requirements for large
systems remain unchanged from the
proposed rule. Text covering small
systems has been clarified (1) to indicate
that the, State may inform small systems
of sampling arrangements other than
those listed in this section, (2) that EPA-
designated laboratories will provide
sampling equipment, and (3) the EPA
will specify sample collection times.
It was suggested that the Agency use
total trihalpmethane (TTHM)
monitoring sites for the microbiological
contaminants. In general, commenters
requested that more explicit
designations be given for
microbiological sampling sites. EPA has
noted that it expects that system specific
sites of normal and maximum residence
time and normal and lowest chlorine
residual will be designated when
revisions to this final rule are made for
contaminants of concern in distribution
systems. These sites have been
designated for other rules, related to
total coliform and total trihalomethane/
disinfectant byproduct sampling.
Further, EPA will propose and
promulgate appropriate monitoring sites
for microbiological contaminants prior
to requiring monitoring for Aeromonas
and other contaminants of interest in
distribution systems. The TTHM
monitoring sites may be appropriate
and, if so, will be included in the future
rulemaking.
(e) What specific sampling and quality
control requirements must I follow for
monitoring of List 1 contaminants?
This section details the requirements
for all systems, including sample
collection, shipping time and reviewing
and reporting results. It also prohibits
compositing samples. Also provided in
this section are requirements unique to
large and small PWSs that are part of the
State Monitoring Plan.
Today's text has been clarified to
indicate that the State or EPA may
inform all systems of sampling
arrangements other than those specified
in the rule. Other changes from the
proposed rule related to large systems
include clarifications on the frequency
of sampling for chemical and
microbiological contaminants
conducted by surface water and ground
water systems, as well as expanded
information on sampling locations.
Regarding small systems that are part
of a State Monitoring Plan, today's rule
notes that the State or EPA may inform
the system of sampling arrangements
other than those specified in the
proposed rule. It also notes that EPA's
laboratory will send additional
instructions for sampling if the first
sampling event was not properly
conducted.
(i) All systems
Overall requirements for all systems
relative to (A) sample collection and
shipping time, (B) no compositing of
samples, and (C) review and reporting of
results were not changed from the
proposed to final rule.
(ii) Large systems
Specific sampling requirements for
large systems are in this section.
(A) Timeframe
One commenter indicated that EPA
should adapt the UCMR process to the
3-year compliance monitoring cycle.
The rule already states that coordination
with the 3-year compliance monitoring
cycle is appropriate.
(B) Frequency
Many commenters were concerned
that requiring ground water samples 6
months apart was not flexible enough to
accommodate other monitoring
schedules. Several commenters also
suggested that systems using
groundwater only be required to collect
one sample per year because ground
water systems do not vary much in
water quality.
EPA has modified the rule to provide
flexibility to the system to pick one of
the three months in the vulnerable time
and then one of three months 5 to 7
months earlier or later than the
vulnerable time. This schedule should
preserve the longer time between
ground water samples desired for
calculating an average annual
concentration for exposure assessment.
EPA will maintain the two samples
for ground water systems. Ground water
systems encompass a wide range of
conditions and many utilize unconfined
settings that do exhibit temporal
variability. To assess exposure from a
one-year sampling activity, most experts
EPA consulted and most stakeholders
agreed that the program must try to
capture the range of contaminant
concentrations that occur to ensure
representativeness of the results over
time nationally. Two samples are the
minimum to estimate an average
exposure; one sample will be targeted
toward the season of elevated
concentrations (the vulnerable
monitoring time). Many experts and
reviewers suggested more frequent
sampling, but the current design was
deemed a reasonable compromise
between data needs and burden. The
UCMR frequency adds one additional
sample over five years for a ground
water site, not one every year. While
some systems may not exhibit much
variability, and some deep systems may
not exhibit any synthetic contaminants,
the UCMR must include the full range
of water system conditions to develop
an accurate estimate of national
occurrence and exposure. Additionally,
with the UCMR monitoring being
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Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations 50589
coordinated with compliance
monitoring (to the extent possible),
approximately one-third of systems
affected by the rule will monitor each
year. Therefore, UCMR Assessment
Monitoring is expected to be conducted
over a range of hydrologic patterns.
This wide range of ground water
conditions also effects the nature of
vulnerable periods. Some ground water
systems show clear seasonal patterns,
some show different scale of variability,
and some show no variations (for some
types of contaminants). For these new
contaminants, EPA set a default
vulnerable period (May, June, or July)
that would fit the majority of vulnerable
seasonal patterns around the United
States. Expert technical reviewers and
stakeholders concurred with this period.
However, the State can specify a
different period, based on their
knowledge of local conditions. EPA
decided not to allow systems to
establish vulnerable periods because of
the need for national consistency to
support a sound statistical approach.
Allowing each system to establish a
vulnerable time would introduce
significant variability in the program
implementation, contrary to the
consistency basis of the statistical
approach for an unbiased sample. EPA
decided that flexibility at the State level
to select an alternate vulnerable
monitoring time was the maximum
allowable variability that should be
incorporated into the implementation of
the program.
(C) Location
A few commenters suggested that EPA
allow source water monitoring,
particularly in States where source
water monitoring is used as a more
stringent location for compliance
monitoring. In related comments, the
Agency was asked to provide further
information about entry points to the
distribution system (EPTDS),
particularly with respect to groundwater
systems with multiple wellhead and/or
using multiple aquifers, suggesting that
representative samples might be
collected instead of from every entry
point.
The sampling location for chemical
contaminants is given on List 1 as the
EPTDS and is now further defined to
include the compliance monitoring
point specified by the State or EPA
under 40 CFR Part 141. In implementing
compliance monitoring, the States and
EPA have made determinations of
where representative samples are
collected, and this rule will incorporate
these determinations and be consistent
with ongoing monitoring. However, if
the compliance monitoring point
specified by the State is a source (raw)
water site, and a UCMR contaminant is
detected, then sampling must be
conducted at the EPTDS unless the State
or EPA determines that no treatment or
processing was in place that would
affect the measurement of the
contaminants. In that case, the
additional sampling at the EPTDS
would not be required.
(D) Sampling instructions
This section did not change and EPA
did not receive any comments on it.
(E) Testing and analytical methods
Several commenters raised questions
about the process for laboratory
certification under the rule. As noted in
the rule, laboratories are automatically
certified for the analysis of UCMR
chemicals if they are already certified to
conduct compliance monitoring for a
chemical included in the same method
being approved for UCMR analysis.
Since the Standard Methods, ASTM,
and AOAC methods approved in the
UCMR use the same technology as the
EPA method listed for the same analyte,
laboratories certified for compliance
monitoring using the EPA method may
also use any of these methods approved
for the same analyte. As the method to
be used for the analysis of perchlorate
will be based upon the currently
available single analyte methods for the
analysis of perchlorate, EPA will need
to conduct a performance evaluation
study of labs to approve them for
perchlorate monitoring before January
2001. Details of this approval system
will be included in a public notice and
comment period prior to conducting
approval for perchlorate analysis.
(F) Sampling deviations
This section did not change and EPA
did not receive any comments on it.
(G) Testing
This section did not change and EPA
did not receive any comments on it.
(iii) Small systems that are part of the
State Monitoring Plan
In the Preamble of the proposed rule,
EPA asked for public comment on
whether a random selection of small
systems across the nation was
appropriate for a representative sample
of small systems or a targeted sampling
approach based on prior information
about contaminant occurrence or use
should be applied. Most commenters,
and particularly expert'technical
reviewers, addressing this issue
supported the random selection of
systems as an unbiased, scientifically
sound approach.
EPA determined after consulting
statisticians inside and outside EPA that
a targeted approach would increase
sampling errors unless the sample size
is increased. A random sample is
necessary to provide small system data
roughly equivalent to large system data.
Further stratification could introduce
non-random sampling errors unless the
sample size is increased. Targeted
monitoring may also miss the target area
if little is known about the actual
location of use of a contaminant or if the
contaminant is used beyond the
specified target area. Additionally,
surface waters will carry contaminants
beyond the target area to surface water
supplied drinking water systems
downstream that need to be considered
for UCMR monitoring. Also, targeting
would be very difficult with the number
of contaminants the UCMR is designed
to measure. Finally, stratified sampling
also requires extensive knowledge about
a variety of factors beyond the fate and
transport of a contaminant in the
environment.
(A) Frequency
Comments and EPA response were
addressed under (ii) Large Systems,
above.
(B) Location
Comments and EPA response were
addressed under (ii) Large Systems,
above.
(C) Sampling deviations
State commenters asked about
resampling if sampling errors occurred.
EPA modified this paragraph to include
provisions for resampling using
additional instructions from the State or
EPA.
(D) Sample kits
No comments were received on this
section. It is unchanged.
(E) Sampling instructions
States indicated that some flexibility
was needed within a month's timeframe
to accommodate changes in sampling
schedules that could not be accounted
for up-front. In response, EPA changed
the specifications. The State Plan will
specify the year and day, plus or minus
2 weeks, to allow flexibility and/or to
account for changes related to the
State's determination of an alternate
vulnerable sampling period. The State
may pick another year and day to
coincide with compliance monitoring.
(F) Duplicate samples
No comments were received on this
section. It is unchanged.
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5059Q Federal Re|ister/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
(G) Sampling forms
No comments were received on this
section. It is unchanged.
(H) Sample submission
At least ten States expressed concerns
about the ability of small system owner/
operators to properly collect samples for
UCMR requirements, which would,
therefore, affect the quality of the UCMR
results. These States suggested that they
could collect UCMR samples for
systems in the State Monitoring Plans
since, in most States, the number of
small systems would be limited, and
some of them already conduct
compliance field sampling for small
systems.
The rule allows for States to sample.
States can address field sampling in
their Memorandum of Agreement
between the State and EPA. EPA would
welcome the assistance of States in
collecting samples from small systems
to ensure high quality data for future
decisions concerning whether or not to
regulate unregulated contaminants.
(f) What additional requirements must I
follow if my system is selected as an
Index system?
This section explains that systems
selected as Index systems must help
EPA or the State identify appropriate
sampling locations and provide
information on the wells and intakes
that are in use at the time of sampling,
on well casing and screen depths (if
Jcnown) for those wells, and the
pumping rate of each well or intake at
the time of sampling. However, EPA
will provide field technical support to
collect samples at index systems and
assist the systems with compilation of
this information, as well as reporting
these data.
Comments were supportive and no
substantive changes were made to this
section.
(g) What must I do if my system is
selected for the Screening Survey or Pre-
Screen Testing?
This section explains what is required
of large and small systems selected to
participate in the Screening Survey or in
Pre-Screen Testing. Today's rule notes
that large systems must report test
results to States and EPA. EPA will be
developing guidance for this reporting
process.
(h) What is a violation of this rule?
EPA added a new §141.40(a)(8) that
clarifies violations of this rule. This
clarification will help public water
systems understand the consequences of
fi failure to monitor. The changes state
that any failure to monitor or report will
be a monitoring or reporting violation.
2. Requirements for State and Tribal
Participation
(a) How can I as the director of a State
or Tribal drinking water program
participate in unregulated contaminant
monitoring, including the State
Monitoring Plan for small systems, and
the Screening Survey and Pre-Screen
Testing of all systems?
Today's final rule incorporates a
variety of changes from the proposed
rule in response to public comments.
Many comments were received
requesting that EPA directly implement
the UCMR, rather than require States to
obtain primacy. In response to these
comments, adoption of this rule is no
longer a condition of maintaining PWS
primacy. EPA will proceed with direct
implementation. However, EPA
recognizes the important role of the
States in this program and has modified
the rule to encourage States and EPA to
enter into Memoranda of Agreement
(MOA) to facilitate State participation
and implementation. EPA also
recognizes that, in the absence of the
option for an MOA, the three-tier
monitoring approach of the UCMR
would require States to apply for
primacy revisions under this program
three separate times (separately for each
of the three lists) over five years;
moreover, the primacy application
period extends beyond the start of
monitoring for each of the three tiers.
Through the MOA, EPA and the State
may also address other aspects of this
final rule's implementation, including
compliance tracking and enforcement.
This section explains that the director
of a State or Tribal drinking water
program can complete an MOA with
EPA that describes the State's or Tribe's
activities in accepting or modifying the
initial monitoring plan, determining an
alternative vulnerable time for
sampling, modifying the timing of
monitoring, identifying sampling points
for small systems, notifying large and
small systems of their monitoring
responsibilities, providing instructions
to systems that are part of the State
Monitoring Plan, and participating in
the Screening Survey and Pre-Screen
Testing.
Regarding the initial plan, EPA will
specify the small systems, rather than
just their number, and the year and day
plus or minus two weeks—rather than
the week, month, and year in the
proposed rule—that each small system
must monitor for List 1 contaminants. A
State can request that a system which
purchases all its water from another
system, as clarified in today's rule, be
removed from the initial monitoring list,
except if it is required to monitor for
contaminants in the distribution system.
Public comments also suggested that
States be allowed to remove systems
from the monitoring list for justifiable
and compelling reasons. States may
remove systems from the plan if the
systems have closed, merged, or
purchase all of their water from another
system. However, in response to
comments, purchased water systems
may be selected to monitor
contaminants in the distribution system,
since purchased water systems tend to
have locations furthest from the
treatment plant. In these cases, they
would be added to the plan as sampling
points in the distribution system for the
systems first selected. In a change from
the proposed rule, States may now
remove systems from the list for other
reasons, subject to review by EPA, as
long as the decision to remove systems
from the list is not based on
contaminant occurrence, non-
occurrence, or potential vulnerability of
a system to a contaminant. Not
removing systems based on prior or
presumed information about
contaminants preserves the statistical
.principle of an unbiased sample.
A State must explain in the State Plan
sent to EPA why it believes a system
should be removed, but the final
decision rests with EPA, as EPA is
responsible for ensuring the integrity of
the national representative sample.
Systems are expected to monitor
between May 1 and July 31, as the
default vulnerable period, but today's
rule allows a State to determine if there
is a different period when any of the
small systems in the initial plan, or any
of the large systems that must monitor,
are more vulnerable to contamination. If
so, a State must notify the affected
systems of when they are to take
samples. If a State changes the
vulnerable time for monitoring, the rule
now indicates, in response to
comments, that the State should also
consider that the effects on modifying
the timing of monitoring. The States
would notify EPA of their determination
through the submission of their revised
Plan to EPA.
The proposed rule required States to
provide EPA with plans for notifying
each PWS selected in the initial or
modified monitoring plan of their
responsibilities and to provide them
with instructions for monitoring. Under
today's rule, establishing the State role
of informing systems of their
responsibilities is part of the State-EPA
MOA.
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Federal Register/Vol. 64, No. 180/Friday, September 17, 1999/Rules and Regulations 5O591
As was the case under the proposed
rule, a State entering an MOA with EPA
must provide instructions to systems
that are part of the State Monitoring
Plan implementation; EPA will provide
guidance on the instructions. Today's
final rule adds new language requiring
a State to inform EPA at least 6 months
before the first monitoring is to occur if
the State plans to do the sampling or to
make alternative arrangements for the
sampling at systems in the plan. The
State also must address the alternative
monitoring arrangements in the MOA
with EPA. These alternative monitoring
arrangements could include the State
sampling at small systems, a change
from, but not precluded in, the
proposed rule.
Today's rule enables States, through a
State-EPA MOA, to participate in
Screening Survey monitoring by small
systems as well as large systems. To
participate, a State must review its State
Monitoring Plan to ensure that no
systems have closed, merged, or
purchase water from other systems
(unless the system is to conduct
microbiological monitoring) and then
make any necessary changes. States also
must notify selected systems of the
Screening Survey requirements.
Under today's rule, States may
participate in Pre-Screen Testing in two
ways. First, within 60 days of receiving
EPA's letter concerning the initiation of
Pre-Screen Testing for specific
contaminants, a participating State must
identify between 5 and 25 systems
determined to be representative of the
systems most vulnerable to the List 3
contaminants. Second, if Pre-Screen
Testing is part of the MOA, a State now
must notify each selected system's
owner or operator of the Pre-Screen
Testing requirements.
Today's rule also notes that if a State
decides not to prepare an MOA with
EPA to develop the State Monitoring
Plan for small systems, the initial plan
provided by EPA will become the State
Monitoring Plan for a State or Tribe.
Under the proposed rule, the initial plan
became the State plan if a State did not
accept the initial plan or submit a
request to EPA to modify the initial plan
within 60 days.
A commenter raised concerns about
whether Tribal systems would be
selected in a random manner to avoid
bias toward selecting vulnerable
systems. EPA will select Tribal systems
at random. The rule treats Tribal
systems the same as other systems with
equal probability of selection.
A commenter was concerned about
who would inform systems of their
responsibility to monitor. As noted
above, the State still plays a critical role
in the successful implementation of the
program, including informing the
systems. If the State elects not to enter
into an MOA, EPA will inform systems
of their responsibilities.
Several commenters asked whether
States should review List 2 systems in
the representative sample at a later date
to check the status of the systems prior
to the Screening Survey. A provision
has been made for later State review of
List 2 systems in the State Plan to check
system status that may have changed
since the initial review.
(b) What if I decide not to enter into an
MOA?
This is a new section not included in
the proposed rule, although it responds
to the previous recognition in the
proposed rule that a State may not
desire to engage in the process of
preparing a State Monitoring Plan. This
section indicates that EPA will carry out
the functions that the State could have
conducted.
(c) Can I add contaminants to the
Unregulated Contaminant Monitoring
List?
This section explains how seven or
more State governors can petition the
EPA Administrator to add one or more
contaminants to the Unregulated
Contaminant Monitoring List.
Except for the numbering of this
subsection, it is unchanged from the
proposed rule.
(d) Can I waive monitoring
requirements?
This section explains that monitoring
requirements can be waived only with
EPA approval and only under very
limited conditions.
Except for the numbering of this
subsection, it is unchanged from the
proposed rule.
A few commenters inquired as to
whether EPA would allow individual
systems to be waived from monitoring.
The statute only provides for State-wide
waivers.
C. Appendix A—Quality Control
Requirements for Testing AH Samples
Collected Under §141.40
This appendix specifies the
requirements that a system must follow
to control the quality of samples
collected and submitted under § 141.40.
Areas covered are sample collection/
preservation, method detection limit,
calibration, reagent blank analysis,
quality control sample, matrix spike and
duplicate, internal standard calibration,
method performance test, detection
confirmation, and reporting.
In response to public comments, a few
minor technical modifications have
been made to the Appendix, modifying
specifications for calibration, matrix
spikes and matrix spike duplicates, and
the number of significant digits
specified for MRLs.
D. Section 142.15—Reports by States
Section 142.15(c)(3) is replaced in its
entirety by the term "Reserved" in
today's final regulation because States
will not go through a primacy revision
process but may be reviewing the data
for quality control purposes before EPA
places them in the NCOD. The wording
in the proposed rule is, therefore, not
included.
E. Section 142.16—Special Primacy
Requirements
Section 142.16(e) is revised to delete
references to § 141.40 that are no longer
relevant.
VET. General Issues From Public
Comment and EPA Response
Several additional issues were raised
during the technical peer review and
public comment processes. They are
summarized and addressed next.
A. Data Quality
One commenter indicated that data
quality objectives should determine
confidence bounds for occurrence and
exposure estimates and that resulting
DQOs should be maintained for all
system sizes. Many data quality
specifications, such as confidence levels
for the representative sample, are
presented in F., Representative sample
of systems serving 10,000 persons or
fewer. EPA will publish other Data
Quality Objectives for the UCMR in the
Quality Assurance Project Plan for the
program.
Commenters indicated that EPA
should give balanced attention to both
false negatives and false positives in
establishing analytical methods and
quality control procedures for the
contaminants on the UCMR List. The
Agency has evaluated analytical
methods developed by both EPA and
other voluntary consensus standards
organizations that publish analytical
methods, such as Standard Methods and
the American Society for Testing and
Materials. The Agency has not approved
analytical methods published only in
analytical journals or methods that use
techniques that cannot routinely be
used by all drinking water analysis
laboratories (e.g., acid, base/neutral
fractionation, or packed column gas
chromatography). Because control of
"false negatives" is essential to the
quality of the data collected under this
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50592 Federal Register/Vol. 64. No. ISO/Friday, September 17, 1999/Rules and Regulations
final regulation, documentation of the
contaminants' stability under the
sample anil extract holding conditions
specified in the analytical method were
also evaluated.
B. EPA Funding for Small System
Testing
Commenters were concerned about
small system testing for which EPA is to
pay the costs. They suggested that if
there is reduced funding, then EPA
should reduce the list, sampling
frequency or number of systems
sampled. EPA currently has sufficient
funds for this rule. If for some reason,
funds are reduced, EPA will consider a
range of options to respond to this
circumstance, but in all cases would
ensure that the rule would not impose
a significant economic impact on small
entities.
C. Lab Certification
liii y,, ' , ; ' -
Commenters were concerned that EPA
heeds to identify steps and procedures
necessary to maintain certification for
unregulated contaminant analysis and
clarify how States are to certify
laboratories in time for implementation
of the rule. EPA will maintain the
process for laboratory certification as it
is. The rule provides an automatic
certification of laboratories that are
certified for the same methods applied
to at least one other contaminant. No
separate certification is required under
the current UCMR.
D. Research
Commenters indicated that EPA
should commit research funds for
Aeromonas and preservation process
studies. EPA is developing a detailed
research agenda with its Office of
Research and Development in support
of the contaminants on the CCL.
E. Regulation Format
Some State commenters indicated that
they may not be able to incorporate this
regulation by reference because it is in
question-and-answer format. EPA is no
longer requiring States to have primacy
to implement the UCMR, so the States
will not have to incorporate the UCMR
into their regulations. However, States
will still be able to participate in the
State Monitoring Plan as specified in a
Memorandum of Agreement between
the State and EPA.
F. Voluntary Data Submittal
One commenter indicated that EPA
should encourage voluntary source
water data if standardized methods were
utilized to substantiate treatment needs.
EPA will pursue obtaining data from
other reliable sources since additional
data will help inform decision
processes. Source water data are
available from other agencies.
IX. Other Changes Related to the
Regulation
A. Implementation of the Rule
Implementation issues addressed in
today's final rule include setting an
effective date, instituting a
memorandum of agreement (MO A)
process with interested States;
establishing the laboratory testing
program; continuing research on
methods development; determining the
representative national sample and
associated State Plans; conducting the
sampling, analysis, and reporting; and
allowing previously collected
monitoring data. The UCMR program, as
revised by today's final rule, is
illustrated in Figure 1, "Unregulated
Contaminant Monitoring Approach." A
critical part of this program is funding
the testing of samples from the national
representative sample of small systems.
BILLING CODE 6560-50-P
jj 3;
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Federal Register/Vol. 64. No. ISO/Friday. September 17, 1999/Rules and Regulations 50593
EPA UCMR
List
up to 30
contaminants
Assessment Monitoring
List 1 (1999) Contaminants
Quarterly for surface water
systems and 2 times 6
months apart for ground
water systems for 1 year,
during 2001-2003
All 2,800 large
systems
Representative
Sample of small
systems (800 of
65,600) identified
by EPA
Two Screening Surveys for
List 2 (1999) Contaminants
300 statistically selected
systems in each of 2 years
(2002 and 2003); same
frequency as Assessment
Monitoring
Pre-Screen Testing
List 3 (1999) Contaminants
up to 200 most vulnerable
systems, 2 times during 2004
7 or more Governors may petition EPA to
add contaminants to list
State may apply
to EPA for
contaminant
monitoring
waiver
State-EPA
MOA for
Implementation
State
Monitoring Plan
for
Representative
Sample
EPA Pays
for Small
Systems in Plan
and in Pre-
Screen Testing
EPA may
waive
electronic
reporting for
PWS
PWS
Reporting
Electronically
17 Data
Elements
Public
Notification,
Consumer
Confidence
Report
Figure 1
Unregulated Contaminant
Monitoring Approach
EPA
National
Contaminant
Occurrence
Database/
SDWIS-FED
State
BILLING CODE 6560-50-C
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50594 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
1. Setting an Effective Date
EPA has testing methods which are
expected to give reliable and
reproducible results for 10 of the
List to be tested for under Assessment
Monitoring. These methods are widely
used in the drinking water industry,
although not necessarily for the listed
contaminants. Testing for these
contaminants, and other information
about them, will help EPA determine
whether to regulate them. Results of the
UCMR testing should be available before
the nexj revision of the CCL. in
February 2003. Additionally, prior to
initiation of the monitoring resulting
from this rule, EPA must establish
laboratory analysis contracts with
laboratories that will do the testing and
associated activities (inducting setting
up a database and electronic reporting
process) establish Memoranda of
Agreement with States to implement the
rule, and develop the national
representative sample and send each
State its allocation for review.
Therefore, EPA has set January 1, 2001,
as the effective date of the UCMR
program, approximately 16 months from
the promulgation of this final rule.
Shortly after this rule is promulgated,
EPA will issue another rulemaking for
public comment to add methods for
perchlorate and acetochlor which were
not previously on List 1. This action
will allow these contaminants to be
tested in 2001 and may allow data
collected prior to the effective date to be
used to meet the requirements of this
final rule.
The 16-month period will enable
States to enter into MOAs with EPA to
provide support for the implementation
of this final rule, to review the initial
State Monitoring Plans, and to inform
small PWSs of their selection and their
responsibilities for monitoring. EPA will
use this time to establish its laboratory
program to test samples from small
systems. Analytical methods are already
in use for the contaminants to be tested
for under Assessment Monitoring, so 16
months should be sufficient for
laboratories that serve large systems to '
organize and implement the testing
program, especially given the assistance
provided by the methods and quality
control manual. EPA is working to
ensure that the manual and the
contaminant occurrence reporting
guidance documents are available to
allow the program's implementation at
that time. The requirements for small
systems and the sampling and quality
control procedures for all systems are
specified in § 141.40(a)(3), (4), and (5)
and in Appendix A. Figure 2 shows the
timing of the major components and
activities supporting the UCMR
program.
BILLING CODE 6560-50-P
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; IP
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Federal Register/Vol. 64. No. 180/Friday. September 17, 1999/Rules and Regulations 50595
1999 2000 2001 2002 2003 2004
2005
UCMR (1999): IMPLEMENTATION ACTIVITIES
UCMR Issued:
Guidance
Available
Representative
Sample selected
bv EPA
National
Contaminant
Occurrence
Database
Operational
State MOAs
and State
Plans
Developed:
InfoimPWSs
Assessment Monitoring:
List 1 (1999) Contaminants
All 2,774 Large and 800 Small PWSs
EPA Contract
Laboratories
Operational
Index System Monitoring
"Up to 30 Small PWSs (2001-2005)"
Screening Surveys:
List 2 (1999) Contaminants
2 Groups of 300 Large and Small PWSs
Screening Survey
Group 2
(2001 or 2002)
Pre-Screening Testing:
States Specify
Vulnerable Systems
Screening Survey
Group 2
(2003 or 2004)
Pre-Screen Testing:
List 3 (1999)
Contaminants
Up to 200 Large
and Small PWSs
(2003 or 2004)
Analyze Results
'and Data Quality'
Next »
Candidate
Contaminant
List Issued
i
Next UCMR
List Issued
Figure 2
Implementation Timeline of
UCMR (1999) and Related Activities
BILLING CODE 6560-50-C
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50596 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
2. Analytical Methods for the Testing
Program
The required methods are identified
in todayks rule at § 141.40(a)(3), Table 1,
"Assessment Monitoring." Additional
sampling and quality control
requirements can be found in
§ 141.40(a)(4) and (5) and in Appendix
A. Large systems are required to follow
the methods and procedures in
§141.40(a)(3), (4). (5) and Appendix A.
Laboratories that test samples from
small systems will also have to comply
with§141.40(a)(3). (4), (5), and
Appendix A.
EPA has prepared guidance
documents to help large systems
organize and conduct their unregulated
contaminant testing programs. The
Agency's draft sampling guidance,
"UCMR Guidance for Operators of
Systems Serving 10,000 or Fewer
Persons" provides details on sampling
requirements. The Agency's
''Unregulated Contaminant Monitoring
Regulation Analytical Methods and
Quality Control Manual" provides
detailed guidance on specific method
requirements related to the unregulated
contaminants on the monitoring list and
on quality control for all testing under
this program.
3. Testing Program for Large Systems
Implementation of today's rule will
result to Assessment Monitoring for List
I contaminants only (including
perchlorate and acetochlor, for which
methods will be addressed in a separate
rulemaking shortly). Analytical methods
are in use for these contaminants, and
EPA plans to review laboratories'
procedures for their testing during
Assessment Monitoring because of this
program's stringent data-quality
requirements.
The Agency anticipates that the
contaminants on List 2, for the
Screening Survey, may be monitored
during the 5-year listing cycle through
a separate rulemaking. EPA will select
a statistically valid random sample of
about 150 large systems to provide
samples to a limited number of EPA-
approved laboratories. The Agency's
approval will depend on a variety of
factors, including its evaluation of (1)
laboratory capability, (2) test results of
blind samples, (3) experience with
similar methodologies, (4) willingness
to accept samples from any PWS
required to monitor under this
regulation, and (5) provision of the
testing for List 2 (and List 3)
contaminants at a reasonable cost to
large systems required to monitor.
Large systems selected for the
Screening Survey (or Pre-Screen Testing
for List 3 contaminants) will be notified
by the State or EPA before the dates
established for collecting and
submitting samples to determine the
presence of contaminants on List 2. For
List 2 and 3 contaminants, large systems
must send samples to laboratories
approved by EPA.
4. Testing Program for Small Systems
Based on a competitive selection
process, EPA will designate one to five
laboratories that will test Assessment
Monitoring samples from approximately
800 small systems in the State
Monitoring Plans and, from the index
systems, over the program's 5-year
cycle. The laboratories will need to be
able to provide all necessary sampling
equipment to these systems, complete
yet easy-to-follow instructions on the
equipment's use, and appropriate
sample preservation and testing
services. They also will have to report
electronically the test results to EPA
and, in an alternate format specified by
EPA if necessary, the PWSs, and'
provide a copy to the States, according
to the reporting requirements of today's
rule.
EPA will review and evaluate
laboratory procedures to ensure that
sufficient testing and data quality
standards are met. Today's requirements
and the final "UCMR Analytical
Methods and Quality Control Manual"
would be part of the testing contracts
that EPA expects to sign with the
selected laboratories.
Once a future rule is finalized to
implement the Screening Survey for List
2 contaminants, EPA will select a
statistically valid random sample of 150
small systems to provide samples
during the two to three years in the
middle of the 5-year cycle. The
laboratories that test for List 1
contaminants for small systems will also
test for contaminants on List 2.
5. Continued Development of Analytical
Methods
EPA has yet to establish analytical
methods for List 2 and List 3
contaminants that can be used widely
and at reasonable cost. The Agency is
establishing, through its Office of
Research and Development, a research
program to identify such methods. As
analytical methods for the List 2 and
List 3 contaminants are developed, EPA
will propose and promulgate them as a
revision to today's rule and solicit
public comments on them. In addition
to specifying the analytical methods to
be used, these future revisions will
establish sampling locations, minimum
reporting levels applicable to the
contaminants, and the dates sampling is
to occur.
6. Determining the Representative
National Sample and State Monitoring
Plans
EPA requires only a representative
sample of up to 800 small systems to
monitor for the presence of unregulated
contaminants in their drinking water.
No later than 6 months prior to the start
of Assessment Monitoring, EPA will
identify, through a statistical selection
process using a random number
generator, up to 800 small systems (from
approximately 65,600 community and
non-transient non-community water
systems) and at least 800 alternate
systems in case replacements are
needed. Each system will have an
approximately equal chance of being
selected based on its source water type
(ground water or surface water) and size
category (25 to 500, 501 to 3,300, or
3,301 to 10,000 persons served). EPA
will notify each State, tribe, and
territory of the selected systems or the
systems themselves (i.e., the initial State
Monitoring Plan) and the alternates
within its jurisdiction.
Each State, tribe and territory can
enter into a Memorandum of Agreement
(MOA) with EPA to participate in the
monitoring program, which will include
development and implementation of the
State Monitoring Plan. Each State, Tribe,
and Territory will have 60 days to
review its initial plan and (1) accept the
plan as its State Monitoring Plan and
inform EPA of that; (2) propose to EPA
deletions from and additions to the
initial plan, and explain the reasons for
the changes, in order to create the State
Monitoring Plan; or (3) choose not to
participate in an MOA to develop the
State Monitoring Plan, in which case,
the initial plan sent to the State will
become the final State Monitoring Plan.
A State, Tribe, or Territory that
chooses option 1 or 2 must also inform
EPA of how and when it will notify the
selected systems of their responsibilities
for monitoring, along with any
necessary modifications to the timing of
sampling related to vulnerable period
determinations or to coordinate with
compliance monitoring, at the State's
discretion. A State may also choose an
alternative "most vulnerable time" for
its systems to sample if systems are
most vulnerable to contamination by
unregulated contaminants during a
period other than May through July, as
specified in today's rule. States that
choose option 3 may still elect to notify
the selected systems and provide the
necessary information about their
monitoring responsibilities as long as
EPA is notified 6 months prior to the
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Federal Register/Vol. 64. No. 180/Friday, September 17, 1999/Rules and Regulations 50597
first unregulated contaminant
monitoring.
The systems randomly chosen by EPA
to be index systems will also be
specified in each State's initial plan.
Any required replacements for the index
systems will come from a list of
randomly selected alternates included
in the plan. EPA expects to provide,
through the laboratories selected to test
for unregulated contaminants,
contractor support in collecting,
shipping, and testing samples and in
gathering additional information to
support these index systems.
The Agency's procedures for selecting
index systems is described in a
technical document, "National
Representative Sample and State Plans
for Unregulated Contaminant
Monitoring at Public Water Systems
Serving 10,000 or Fewer Persons."
Although monitoring for List 2
contaminants is not required by today's
rule, EPA will provide with the initial
State Monitoring Plans a list of systems
that would monitor for List 2
contaminants once a future rule
implementing the Screening Survey is
promulgated. The Agency will select
randomly about 180 small systems and
120 large systems when it prepares the
initial plans. States will review these
systems at the same time they review
their initial plans. EPA believes that the
analytical methods for List 2
contaminants will be ready for use
during the first 3 years of the 5-year
listing cycle and that the Screening
Survey will be undertaken during that
period.
For the Pre-Screen Testing, each State
may specify 5 to 25 systems that are
representative of systems most
vulnerable to the contaminants on List
3. EPA will determine the exact number
of systems to be selected in each State
based on the population served by
community and non-transient non-
community water systems. Each State
must add to its monitoring plan any
small systems selected for Pre-Screen
Testing and will notify EPA of their
addition.
7. Specifying the Vulnerable Monitoring
Period
Each State may modify the vulnerable
monitoring period specified in
§ 141.40(a) (5) (ii) (B) for a single system,
a group of systems, or all systems
selected to perform monitoring. In
changing the vulnerable period, the
State may consider environmental,
precipitation, and system-specific
factors. For small systems in the State
Monitoring Plan, changes in the
vulnerable time must be included in the
Plan.
8. Conducting the Sampling
All selected systems must monitor for
the unregulated contaminants on List 1
and should coordinate, at State
discretion and to the extent practical,
with their compliance monitoring
schedule for regulated chemicals. For
small systems in State Monitoring Plans,
States may also select an alternative
year and day, plus or minus two weeks,
within the 3 year monitoring time frame
for Assessment Monitoring as long as
approximately one-third of the systems
in the State Monitoring Plan monitor in
each year of the 3 year period. Surface
water-supplied systems must monitor
for chemical contaminants every 3
months during a 12-month period, and
ground water-supplied systems must
monitor for them once approximately
every 6 months during a 12-month
period of every 5-year testing cycle
beginning in the years indicated in
column 6 of UCMR Table 1, List 1,
§ 141.40(a)(3). One sample must be
taken at each post-treatment distribution
system entry point or other
representative sampling point
designated by the State for compliance
monitoring under 40 CFR 141.24(f)
representing all principal, non-
emergency water sources in use during
the 12-month period, or at each
distribution sampling point, during May
to July unless the State identifies a
period when one, some, or all of its
systems are more vulnerable to
contamination by List 1 chemicals.
For microbiological contaminants, a
PWS must monitor at a site in the
distribution system that represents the
water supplied to the system's
customers and at a site in the
distribution system that has the
maximum residence time or lowest
disinfectant residual, depending on the
contaminant. This also would apply to
PWS that purchase their water supply
from another system. One set of samples
must be taken during the system's most
vulnerable time, defined as May 1
through July 31 in today's final rule, or
at a time designated by the State as the
must vulnerable period, and another set
of samples must be taken approximately
5-7 months before or after.
The 5-year unregulated contaminant
listing cycle can be coordinated with the
3-year compliance monitoring schedule
by starting the next 5-year monitoring
round in January 2001 and taking UCM
samples when compliance sampling is
performed, regardless of where the 3-
year cycle is in a particular State.
Sampling in the rest of the State would
occur during the next 2 years, following
the State's compliance monitoring
schedule. Even though a system is not
sampled for regulated contaminants
during the 5-year UCMR listing cycle, it
may be required to monitor for
unregulated contaminants during that
time.
9. Establishing Sampling Points
Today's rule specifies that sampling
must be done at entry points to the
distribution system, or at sampling
points designated by the State to be
representative compliance monitoring
sites under 40 CFR 141.24 (f)(l), (2), or
(3). For systems that are required to
monitor source (raw) water for
compliance purposes, the UCMR
program accommodates these
compliance sites in the following way:
If sampling and testing at source water
compliance sampling points results in
detection of any UCMR List 1
contaminants, then Assessment
Monitoring must shift to entry points to
the distribution system for unregulated
contaminants unless there is no
treatment.
10. Large Systems
For Assessment Monitoring, large
systems will follow the sampling
requirements in § 141.40. They are
explained further in the draft methods
and quality control manual.
11. Systems in State Monitoring Plans
EPA's "UCMR Guidance for Operators
of Public Water Systems Serving 10,000
or Fewer Persons" explains the
responsibilities of PWSs that are part of
the representative sample and State
Monitoring Plan. It also explains further
the requirements for operators of small
systems, which are found at
§141.40(a)(3), (4), (5) and Appendix A,
and addresses sampling including
frequency and location, receipt and use
of sampling equipment, shipping
samples to laboratories, reviewing the
results, and reporting. States can use the
guidance to give monitoring schedules
and instructions to systems when
informing them of their responsibility to
participate in the representative sample
and State Monitoring Plan.
Small systems that are part of a State
Monitoring Plan must sample at the
locations specified in the regulation,
similar to the other systems described
previously. EPA will inform the
competitively selected laboratories
about which systems are included in the
State Monitoring Plans and should
therefore receive sampling equipment.
Ten percent of the systems in the
State Monitoring Plans will be randomly
selected to collect duplicate samples for
quality control purposes. These samples
will be collected using the same
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50598 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
Except for publishing the List 3
ntamlnants as part of the revised
procedures as those for the first sample
collectlpn.
12. Screening Survey
The Screening Survey is not part of
today's rule. Today's rule only
publishes the UCMR (1999) List 2
contaminants that systems will monitor
'.. I ',: ; ], for once the necessary analytical
1 _!'- ""'* '(Methods' are "developed, peer reviewed,
proposed, arid promulgated. When the
methods are ready, EPA will issue a rule
requiring large and small PWSs to
collect water samples and submit them
for testing to determine the presence of
specified contaminants. EPA will pay
|pr the shipping and testing of samples
collected by small systems in State
Monitoring Plans.
13. Pre-Screen Testing
,: j Excei
contaminants as part
UCMR |l 999) list, Pre-Screen Testing is
not part of today's rule. Once analytical
methods for these contaminants are
developed, peer reviewed, proposed and
promulgated. EPA will promulgate a
rule specifying the sample locations and
dates, analytical methods to be used,
ahd minimum reporting levels.
Pre-S.creen Testing will be a limited
sampling ""'arid testing effort, conducted
under controlled conditions. EPA will
ask States to identify, within 90 days of
the request, 5 to 25 large and small
systenis Vulnerable to List 3
contaminants so that EPA will have a
national sejt of up to 200 systems to
collect sampies. The Agency intends to
use the results of this testing to
determine whether a more
representative monitoring effort should
be made through Assessment
Monitoring of a Screening Survey.
Although the samples will come from
the most vulnerable systems in the
country'and not from a statistically
Valid, randomly selected group of
%stems'EPA could decide to regulate
one or more of the List 3 contaminants
if monitoring and other available
information shows a clear and present
threat to public health.
Persons taking samples to be tested
for certain contaminants may require
specific training and skills to ensure the
integrity of the samples. In such cases,
EPA may contract for sampling services,
and the PWS owner/operator would be
required only to provide access to the
sampling locations.
The Agency will pay for shipping and
testing samples from small systems
participating in the Pre-Screen Testing.
EPA will forward testing results for
review by the PWSs and States before
posting them on the NCOD where the
public can access them. Large systems
will pay for sampling, shipping, and
testing at EPA-approved laboratories,
arid they will report the results to EPA
and provide a copy to the State. EPA
will enter the data into the NCOD.
14. Testing
As explained previously, EPA has
prepared a methods and quality control
manual for taking samples and
analyzing them for contaminants on the
monitoring list. The manual covers the
requirements found in § 141.40(a)(3),
(4), and (5) and Appendix A. EPA will
make the manual available to systems,
States and other interested parties in
hard copy and on the Internet.
Laboratories testing for unregulated
contaminants at the request of PWSs
will need to follow the requirements of
§ 141.40 and Appendix A. EPA plans to
establish a program to review methods
implementation and performance of the
participating laboratories.
For small PWSs in State Monitoring
Plans, EPA will identify through
competitive bids one to five laboratories
that will test their water samples for the
presence of unregulated contaminants.
The Agency is doing this so it can pay
for the testing of samples from small
PWSs. Later this year, EPA will seek
bids from laboratories that wish to be
considered for this effort. The first
samples are expected to be available for
testing after January 1, 2001.
For large systems required to test for
contaminants on Lists 2 and 3, EPA will
open a process to approve on a
competitive basis, a limited number of
laboratories for these analyses. This
approval process will occur as EPA
specifies methods for Lists 2 and 3
contaminants.
15. Reporting Requirements
The results of contaminant testing
will have to be reported along with the
17 data elements identified in today's
rule. Inventory data about systems
(including PWS facility identification
numbers allowing association of
treatment plants to sampling points, and
latitude and longitude of treatment
plants) reported by States will be
addressed separately in Safe Drinking
Water Information System Inventory
Reporting Requirements. PWSs are
responsible for reporting electronically
to EPA, unless EPA specifies alternative
reporting requirements, such as a
standard paper form that can be
electronically scanned to make the data
available in electronic format for
computer storage, retrieval, and use.
The PWSs must also provide a copy of
the results to their States.
Small systems listed in State
Monitoring Plans and large systems will
have to report five data elements to the
laboratory testing its samples: PWS
identification number; PWS facility
identification number for source (intake,
well or wellfield), treatment plant, and
sampling points; water source type;
sample identification number; and
sample collection date. The remaining
data elements will be provided by the
laboratory. If systems have not
previously reported PWS facility
identification number for sources,
treatment plants and sampling points
prior to their first UCMR report, then
they must do so at the time of the first
report. This information must be
reported so that each sampling point
used for UCMR sampling must be able
to be associated with its treatment
plant(s) and source (s) in use at the time
the sampling occurred.
For systems demonstrating that they
are not able to report electronically, EPA
may specify an alternative reporting
format that will allow EPA to enter the
system's data into the National Drinking
Water Contaminant Occurrence
Database. EPA will use the
"Unregulated Contaminant Monitoring
Reporting Guidance" to guide the
development of this alternative
reporting format.
16. Record Keeping
Today's rule does not change PWSs'
responsibility for keeping records of
data from unregulated contaminant
monitoring, which are presented in
§141.33, for PWSs.
17. Previously Collected Data
Public water systems that have
previously collected data on List 1 may
submit this information. However, this
data must meet the specific testing and
reporting requirements as described in
today's final rule.
18. Modifying the Monitoring List
As required under SDWA Section
1445, EPA will modify the Unregulated
Contaminant Monitoring List, Table 1,
every 5 years to include the
contaminants of greatest concern at that
time. If EPA still requires additional
data for some previously listed
contaminants, they may remain on the
list. Within each 5-year listing cycle,
EPA will also modify the monitoring list
to include the analytical methods for
Lists 2 and 3 contaminants and their
related sampling requirements. These
modifications will occur through future
rulemaking, with opportunity for public
comment.
Funding for Testing of Samples for
Systems in State Monitoring Plans and
for Pre-Screen Testing. EPA will pay the
cost of testing samples taken from small
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Federal Register/Vol. 64. No. 180/Friday. September 17, 1999/Rules and Regulations 50599
systems pursuant to a State Monitoring
Plan. These payments will be made
directly to EPA-approved laboratories
that meet the requirements of
§ 141.40(a)(3), (4), (5), and Appendix A.
which are further described in the
methods and quality control manual.
The Agency expects to minimize costs
of testing and take advantage of
economies of scale through this
approach, rather than reimbursing 800
systems for analytical costs at up to 800
different laboratories. Administrative
costs will be less with this approach and
contracted testing costs for a larger
volume of samples should be less.
Two funding sources are available to
pay for testing of these small system
samples to carry out the provisions of
SDWA Section 1445(a)(2)(C). Since FY
1998, EPA has been required to reserve
annually $2 million from funds
appropriated for the Drinking Water
State Revolving Fund (DWSRF) to pay
for unregulated contaminant testing.
SDWA Section 1445(a)(2)(H) authorizes
$10 million each year through FY 2003
to carry out all aspects of the UCMR
program, including paying to test
samples from small systems under State
Monitoring Plans. Currently, $2 million
from the DWSRF set-aside for FY 1998
and FY 1999 are available to support
unregulated contaminant monitoring for
small systems. EPA will use this set-
aside in future years to pay for this
testing and for the testing of samples
drawn from small systems participating
in the Screening Survey and Pre-Screen
Testing. If funding for the UCMR
program changes, however, EPA will
need to consider how to accommodate
reduced funding. The Agency could, for
example, recalculate the representative
sample size to a lower confidence level
commensurate with available resources.
B. Implementation in Indian Country
Several provisions of this rule apply
to State governments, and this preamble
section clarifies how they will apply in
Indian country.
As explained earlier, EPA intends to
include all small systems in Indian
country in a single, separate group. Like
small systems in each State, small
systems anywhere in Indian country
may be selected at random to participate
in the UCM program. EPA will not,
however, notify the State of the systems
selected and allow the State to select
alternatives for systems that have
closed, merged, or that purchase their
water from other systems. Instead, EPA
will contact the appropriate tribal
governments for that purpose. The
resulting group of systems will compose
the single "State Plan" for Indian
country. The EPA will notify selected
systems of their UCMR responsibilities.
Tribes with "treatment as a State"
status may enter into an MOA with EPA
to provide support in implementing the
UCMR for small systems monitoring
plans. For systems on tribal lands of
Tribes not having "treatment as a State"
status, EPA will serve as the point of
contact with the system and will
implement the UCMR with the tribe. In
either case, the steps of implementation
would be the same as those described
previously.
C. Performance-based Measurement
System
EPA's Office of Water plans to
implement a performance-based
measurement system (PBMS) that would
allow the option of using either
performance criteria or reference
methods in its drinking water regulatory
programs, removing the requirement
that only EPA-specified and approved
analytical methods be used in SDWA
regulatory programs. The requirement to
use approved methods for SDWA
regulatory programs would, however, be
maintained for certain method-defined
analytes (e.g., Total Coliform and
asbestos), and for data gathering
prospective to regulation, such as the
contaminant monitoring in this rule.
As noted above, many of the
contaminants of interest for the
Unregulated Contaminant Monitoring
(UCM) program can be classified as
"emerging" and thus do not have
existing performance criteria or
reference methods. In addition to
collecting information about
contaminant occurrence, the UCM
program will enable the development of
reference methods and performance
criteria. UCM testing will provide data
to assist the Agency in developing
performance criteria that would be
proposed with the MCL, monitoring
requirements, etc. for an analyte. For
these reasons, the Agency is specifying
the method to be used for UCM testing.
Once, however, a contaminant proceeds
to regulation development as an
NPDWR, EPA expects to have sufficient
data and method development
information to be able to propose both
performance criteria and a validated
reference method, either of which could
be used for compliance monitoring of
the contaminant.
X. Guidance Manuals
EPA will provide a guidance manual
to further explain the quality control
measures that laboratories will need to
perform for all unregulated contaminant
monitoring. For systems that are part of
State Plans for representative samples,
the sampling guidance, "UCMR
Guidance for Operators of Public Water
Systems Serving 10,000 or Fewer
Persons", will be available. Commenters
asked for additional time to review the
guidances for implementing this
regulation. EPA will provide additional
time for review and comment on the
guidances: (1) UCMR Guidance for
Operators of Public Water Systems
Serving 10,000 or Fewer Persons; (2)
UCMR Integrated Guidance; (3) UCMR
Reporting Guidance; (4) Contaminant
Selection, Methods, and Sampling:
Technical Background Information for
the UCMR. The guidance and manual
"UCMR Analytical Methods and Quality
Control Manual" and "National
Representative Sample of Small Public
Water Systems: Statistical Design and
State Plans for the UCMR" will be
available through the EPA Safe Drinking
Water Hotline at 800-426-4791, or
through EPA's Office of Ground Water
and Drinking Water Homepage at
www.epa.gov/safewater at the time of
promulgation of this rule. EPA would
apply these same testing and quality
control procedures to the samples of all
monitored systems. These final
procedures are discussed in more detail
in Section D. "Monitoring Requirements
Under the Final UCMR".
XI. Costs and Benefits of the Rule
A. Program Cost Estimates
Today's final rule requires that only
Assessment Monitoring for List 1
contaminants (12 chemical
contaminants) be conducted over a 3-
year period by all 2,774 large PWSs and
a randomly selected representative
sample of 800 small systems.
Perchlorate and acetochlor monitoring
will be activated under List 1 shortly
after today's rule, by a separate
regulation that will add the methods for
those contaminants. Monitoring for
contaminants on Lists 2 and 3 will wait
until EPA promulgates rules to initiate
the Screening Survey and Pre-Screen
Testing.
Labor costs pertain to systems, State
primacy agencies, and EPA. They
include activities such as reading the
regulation, notifying systems selected to
participate, sample collection, reporting,
record keeping, and data analysis.
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. The Agency also will incur
non-labor costs in procuring services to
conduct quality assurance surveys at
contract laboratories and in collecting
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50600 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules' and Regulations
samples at a select number of Index
systems.
Laboratory analysis accounts for
almost 70 percent of the national cost
for a program such as this one. These
costs generally are calculated as follows:
the number of systems multiplied by the
number of sampling points is multiplied
by the sampling frequency and then
multiplied by the cost of laboratory
analysis. (This calculation is repeated
for each separate analytical method).
Shipping is added to the calculated
costs to derive the total direct analytical
;,, non-labor coste. Instead of assuming
that large systems wiffi pay trie full
analytical costs for Assessment
Monitoring, EPA assumes they will pay
smaller "incremental" analytical costs
bWause UCMR mordtoring will coincide
with ongoing Phase fiTV compliance
monitoring. In some cases, UCMR
analyses use the laboratory analytical
piethpds required for ongoing
Compliance monitoring. Therefore,
when unregulated contaminant
monitoring and Phase DYV monitoring
are conducted concurrently, only
incremental fees are charged for the
analysis of additional UCMR
tompdiinds. Of course, if analyzing
samples for some unregulated
contaminants requires testing methods
that are not currently in use, no cost
savings can be realized. Note that, since
the methods for perchlorate and
Scetochlor have a "Reserved" status in
this rule promulgation, costs for these
contaminants will be estimated when
the rule revisions for these methods are
published.
The details of EPA's cost assumptions
and estimates can be found in the
Information Collection Request (ICR)
prepared for this rule (ICR No. 1882.01).
\vhich presents estimated costs and
burden for the 1999-2001 period. It was
lent to the Office of Management and
Budget (OMB) on April 15.1999. A
background cost document, "Burden
and Cost Calculation for the
Unregulated Contaminant Monitoring
feegulation," is attached as an appendix
to the IgR. It presents the total and the
estimated annual cost and burden for
the final rule's first 5-year cycle (from
2001 to 2005). Some of the costs EPA
estimated are associated with program
start-up and may not recur in future
monitoring cycles. Although some of
these start-up costs might be incurred
before 2001, they are included and
averagea as part of the 5-year program
costs to simplify the calculations;
systems will incur costs only during the
5-year monitoring cycle. Copies of the
ICR may be obtained from Sandy Farmer
by mail at: Office of Policy Regulatory
Information Division; U.S.
Environmental Protection Agency
(2137); 401 M St., S.W.; Washington, DC
20460, by email at:
farmer.sandy@epa.gov, or by calling:
(202) 260-2740. A copy may also be
downloaded from the Internet at: http:/
/www.epa.gov/icr.
In preparing the UCMR ICR, EPA
relied on standard assumptions and data
sources used in the preparation of other
drinking water program ICRs. These
include the public water system
inventory, number of entry points per
system, and labor rates. To estimate the
labor burden for State and some system
activities, the Agency used its standard
State Resource Model, which is
documented in the Resource Analysis
Computer Program for State Drinking
Water Agencies (January 1993). Other
assumptions are discussed next.
1. Assumptions: Assessment Monitoring
EPA's estimated cost of Assessment
Monitoring is based on the following
assumptions:
• Surface water systems will sample
4 times during 1 year and ground water
systems will sample twice during 1 year
in the 5-year UCMR program cycle.
• EPA will pay the testing costs for
the representative sample of 800 small
systems, which will be performed by
selected laboratories.
• Large systems will pay for their
own testing, which will be performed by
laboratories of their choice (in
accordance with UCMR program quality
control requirements).
• All systems will, to the extent
practical, conduct their chemical
sampling along with their standard
compliance monitoring to reduce labor
burden and analytical costs where
possible.
In addition, various quality assurance
and quality control measures (e.g., 10
percent duplicate samples from the
representative systems) will be in effect.
Water samples also will be taken from
a group of 30 small "Index systems" (a
subset of the national representative
sample of small systems) during all 5
years of the monitoring cycle to assess
any trends in temporal occurrence,
other data variability, or program
problems.
2. Estimated Average Annual Cost for 5--
Year Program: Assessment Monitoring
Only
EPA estimates that the average annual
cost of nationwide Assessment
Monitoring is approximately $8.4
million, as follows:
• EPA: $3.1 million, including $2.0
million in testing costs for small
systems.
• States: $461,500.
• Small systems: $16,440.
• Large systems: $4.8 million.
The estimated average annual cost
(labor plus non-labor) is approximately
$21 per participating small system and
$1,735 per large system.
These average annual costs do not
represent the peak costs expected to be
encountered during program
implementation. Most of the
monitoring, and hence most of the costs,
are expected to occur over a 3-year
period, allowing for follow-up work and
data review, reporting, and analysis.
EPA's peak year costs (during the 3 core
years of Assessment Monitoring
primarily for the representative sample)
are estimated to be $3.6 million for
Assessment Monitoring. Peak year costs
for large systems are projected to be
about $8.0 million for Assessment
Monitoring.
B. Estimated Net Costs
EPA estimated the UCMR program's
net cost by comparing the new program
costs, with the estimated costs of the
unrevised program (i.e., the baseline
costs). The standard labor rates and
activities used to estimate the new
program costs were also used to
determine the baseline costs, and the
same water inventory numbers were
used for the comparison. A simplifying
assumption with respect to the
baseline'that all systems serving more
than 500 persons monitor during the
sa'me 5-year interval—was also made.
The Agency also had to address
several differences between the two
programs. The regulation replaced by
today's rule did not require systems
serving 150 or fewer service connections
to monitor for unregulated contaminants
unless requested to do so by the State.
Data in the drinking water program
information system suggest that State
required about one-third of the systems
serving 500 or fewer people to monitor;
thus one-third of systems serving 150 or
fewer service connections were
included in EPA's baseline estimates.
Another significant difference
between the previous program and the
new one is the list of contaminants for
which monitoring is required. The
previous regulations required
monitoring for 48 chemicals included in
Table 1 of the Proposed Rule Preamble
(64 FR 23401). (Although monitoring for
14 of the chemicals was discretionary,
their associated costs were derived from
the analytical method required for the
other unregulated contaminants and the
regulated volatile organic compounds
[VOCs]. Consequently, they do not make
a substantive difference in the cost
estimates.) Although the previous
program required monitoring for more
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Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations .50603
contaminants than does the program
implemented by today's final rule,
monitoring requirements of the previous
UCMR program were derived from
fewer analytical methods, and all were
derived from standard methods used for
routine compliance samples. Hence, the
analytical costs were relatively lower.
Given' the above assumptions and full
implementation over 5 years, the
revised UCMR program will save small
drinking water systems an estimated
$35.8 million over the estimated
baseline. The annual costs for each
small system participating in
unregulated contaminant monitoring are
reduced an estimated $190. Small
systems will realize this saving because,
unlike the previous program, the new
program does not require any of them to
pay for the analysis of water samples to
determine the presence of unregulated
contaminants. Only small systems
chosen for the representative national
sample will incur any costs, and they
will be labor costs only.
Under the UCMR Assessment
Monitoring program, large systems will
face a $10.2 million increase in costs,
primarily from the increase in
laboratory analytical costs. Average
annual large system costs are estimated
to increase by approximately $730
under the new UCMR program.
EPA estimated the baseline costs to
the States at $7.5 million over the 2001-
2005 monitoring cycle, plus year 2000
start-up costs. Total estimated saving to
States under the revised UCMR program
is an estimated $5.2 million. This saving
will be primarily in labor costs because
the States will have oversight
interactions with only 800 small water
systems, far fewer than previously were
involved in unregulated contaminant
monitoring.
EPA estimated that it would have cost
the Agency $1.9 million to run the
previous monitoring program over the
2001-2005 monitoring period, plus
start-up costs. The Agency's costs are
estimated to almost double under the
revised Assessment Monitoring program
primarily because it will fund sample
shipment and analysis for small
systems.
The cost reductions also can be
attributed to the "Suspension of
Unregulated Contaminant Monitoring
Requirements for Small Public Water
Systems (Direct Final Rule)," which was
published in the Federal Register on
January 8, 1999. It suspended the
requirement for small systems to
perform another round of monitoring for
unregulated contaminants because it
would have overlapped with the revised
UCMR program. Approximately two-
thirds of the systems between 3,300 and
10,000 persons will save the cost of
monitoring in 1999 and 2000 by the
action of the Direct Final Rule, resulting
in a savings of about $5.3 million for
these systems.
C. Benefits
Today's rule significantly reduces
burden, especially for small water
systems. The original UCMR program,
initiated in 1988, required all
community water systems (CWSs) to
monitor for 48 contaminants. States
could waive the requirement for systems
serving 150 or fewer service
connections, although these systems
had to be available for monitoring under
the regulation. Analysis of the first
round of data, from 1988 to 1993,
indicates that well over 25,000 PWSs
were involved in the original
monitoring program. The revised
program will involve only 3,574 to
3,724 systems: 2,774 large systems and
up to 800 small systems.
The systems that will be regulated
under today's rule will monitor for
fewer contaminants than was the case
under the original UCMR program. EPA
will pay the small systems' costs of
testing, keeping their burden to a
minimum and limiting it to collecting
the samples and contacting a shipping
service to pick them up for delivery to
a laboratory. The Agency also will
manage the laboratory testing program
for these systems, minimizing the time
they interact with the laboratories. The
laboratories contracted by EPA to
perform the analyses also will provide
electronic reporting services for small
systems that lack this capability.
Consequently, the costs borne by the
selected 800 systems will be
substantially reduced under the revised
program.
Regarding the full UCMR program,
cost savings can be attributed to the use
of a small sample of small and large
systems in the Screening Surveys and
Pre-Screen Testing. The two Screening
Surveys of 300 systems each and the
Pre-Screen Testing of up to 200 systems
will allow statistically valid, targeted
approaches to be applied to emerging
contaminants. These early screening
efforts will help EPA determine whether
contaminants are already in public
water systems and whether they should
be monitored for in the subsequent 5-
year monitoring cycle. This approach—
rather than requiring Assessment
Monitoring for all 30 contaminants at all
monitored systems—is projected to save
large water systems and EPA more than
$50 million in annual Assessment
Monitoring costs.
State burden also will be reduced. A
substantial portion of State burden
depends on the number of systems that
a State must manage. Although the
revised UCMR program introduces some
new elements, fewer systems are
involved so State oversight activity (e.g.,
system notification and record keeping)
will be reduced.
Today's final rule increases the
number of data elements that must be
reported from 12 to 17. These data must
be reported with each sample to make
the monitoring data more useful for
analysis. However, the additional
burden on systems is minimal, because
most of the data elements will be
reported to EPA by laboratories which
already routinely record many of them.
The long-term benefits of the revised
UCMR program are:
• Contaminants whose occurrence in
drinking or source water is not
widespread will be identified early,
which will enable evaluations and
decisions to minimize further the
monitoring and resources that would
otherwise be committed to those
contaminants.
• Contaminants whose occurrence in
drinking water is widespread will
trigger additional research on health
effects and treatment as soon as
practical to protect the health of
sensitive persons.
• The use of a representative sample
of small systems (which comprise the
majority of PWSs) can provide a
scientifically sound, statistically valid
data set that can be used for improved
analysis and program decisions at
reduced cost.
XII. Administrative Requirements
A. Executive Order 12866—Regulatory
Planning and Review
Under Executive Order 12866 (58 FR
51735, October 4, 1993), the Agency
must determine whether a regulatory
action is "significant" and therefore
subject to 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
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50602 Federal Register/Vol. 64. No. ISO/Friday, September 17, 1999/Rules and Regulations
(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.
B. Executive Order 13045—Protection of
Children From Environmental Health
Risks and Safety Risks
Executive Order i36457"Protection of
Children from Environmental Health
Risks and Safety Risks" (62 FR19885,
April 23,1997). applies to any rule that
(l) is determined to be "economically
significant" as defined under E.O. 12866
and (2) concerns an environmental
health or safety risk that EPA has reason
to believe may have a disproportionate
effect ojj 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 jule is not subject to E.O. 13045
because it is not "economically
significant*' as defined under E.O.
12866. Further. EPA interprets E.O.
13045 as applying only to those
regulatory actions that are based on
health or safety risks, such that the
analysis required under section 5-501 of
the Order has the potential to influence
the regulation. This final rule is not
^ubject to E.O. 13045 because it does not
establish an environmental standard
Intended to mitigate health or safety
risks. For the most part, this rule
establishes procedures for monitoring of
unregulated contaminants on the
Agency's CCL. Given EPA's interest in
protecting children's health, however,
as part of the provisions in the rule
allowing State governors and Indian
•tribes to petition EPA to add
contaminants to the Unregulated
Contaminant Monitoring List, EPA asks
them specifically 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 future lists.
This final rule is part of the Agency's
overall strategy for deciding whether to
regulate the contaminants on the CCL
(63 FR 10273). Its purpose is to ensure
that EPA has data on the occurrence of
contaminants on the CCL where those
data are lacking. EPA is also taking steps
to ensure that the Agency will have data
on the health effects of these
contaminants on children through its
research program. The Agency will use
these occurrence and health effects data
to decide whether to regulate any of
these contaminants.
C. Unfunded Mandates Reform Act
Title H of the Unfunded Mandates
Reform Act of 1995 (UMRA), Pub L.
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 UMRA section 202, EPA
generally must prepare a written
statement, including a cost-benefit
analysis, for proposed and final rules
with "Federal mandates" that may
result in expenditures to State, local,
and tribal governments, in the aggregate,
or to the private sector, of $100 million
or more in any one year. Before
promulgating a rule for which a written
statement is needed, UMRA section 205
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 UMRA section 203 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
for the private sector in any one year.
Total annual costs of today's rule for
State, local, and Tribal governments and
the private sector, are estimated to be
$7.3 million, of which EPA will pay
$2.0 million, or 27 percent. Thus,
today's rule is not subject to the
requirements of UMRA sections 202 and
205.
EPA has determined that this rule
contains no regulatory requirements that
might significantly or uniquely affect
small governments because EPA will
pay for the reasonable costs of sample
testing for the small PWSs required to
sample and test for unregulated
contaminants under this rule, including
those owned and operated by small
governments. The only costs that small
systems will pay are the costs attributed
to (1) the labor associated with reading
the regulations, guidance, and
instructions to implement the
monitoring requirements, (2) collecting
the samples and packing them for
shipping to the laboratory (EPA will pay
for shipping), and (3) reporting and
record keeping. These costs are not
significant. Thus, today's rule is not
subject to the requirements of UMRA
section 203.
D. Paperwork Reduction Act
The Office of Management and Budget
(OMB) has approved the information
collection requirements contained in
this rule under the provisions of the
Paperwork Reduction Act, 44 U.S.C.
3501 etseq. and has assigned OMB
control number 2040-0208. An
Information Collection Request (ICR)
document which presents estimated
costs and burdens for the 1999-2001
period has been prepared by EPA (ICR
No. 1882.02). A background cost
document, "Burden and Cost
Calculations for the Unregulated
Contaminant Monitoring Regulation," is
attached as an appendix to the ICR and
presents the estimated costs and
burdens for the first 5-year cycle of the
final rule. A copy of these may be
obtained from Sandy Farmer by mail at
OP Regulatory Information Division;
U.S. Environmental Protection Agency
(2137); 401 M St., S.W.; Washington, DC
20460; by email at:
farmer.sandy@epa.gov; or by calling:
(202) 260-2740. A copy may also be
downloaded from the Internet at:
http://www.epa.gov/icr.
The information to be collected under
today's rule is to fulfill the statutory
requirements of section 1445 (a) (2) of the
Safe Drinking Water Act, as amended in
1996. The data to be collected will
describe the source 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 regulations
accordingly. Reporting is mandatory.
The data are not subject to
confidentiality protection.
Burden is defined as the total time,
effort, or financial resources expended
by persons to generate, maintain, retain,
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Federal Register/Vol. 64. No. 180/Friday, September 17, 1999/Rules and Regulations 50603
or disclose or provide information to or
for a Federal agency. This includes the
time needed to review instructions;
develop, acquire, install, and use
technology and systems to collect,
validate, verify, process, maintain,
disclose, and provide 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.
The annual burden and cost estimates
described below are for the
implementation assumptions put forth
in this Rule, which includes only the
Assessment Monitoring component of
the UCMR Program. For Assessment
Monitoring, the respondents are 800
small water systems (in the national
representative sample of systems
serving 10,000 or fewer people), 2,774
large public water systems, and 56
States and primacy agents (3,630 total
respondents). The frequency of response
varies across respondents and years.
System costs (particularly laboratory
analytical costs) vary depending on the
number of entry or sampling points.
For the three-year ICR period 1999-
2001, small systems will sample and
report an average of 2.7 times for the
entire period. The burden for small
systems is estimated to be an average of
1.5 hours annually per system, with an
annual cost of $31. Large systems will
sample and report an average of 2.9
times for the entire period, and are
estimated to have a 3.3 hour per system
annual burden, with a labor cost of $93
per year. Non-labor costs per year for
these systems is estimated at $2,798 per
system. On average, States are assumed
to report quarterly during each UCMR
implementation year. It is estimated that
each State will incur 141 hours of
burden per year, with an annual labor
cost of $5,647 for the ICR period 1999-
2001. Non-labor costs for States were
assumed to be minimal, with 10 percent
of the States incurring a one-time
$25,000 contractor cost for the optional
upgrading of their drinking water
databases; an average of $833 per year
per State for the ICR period. In
aggregate, the average respondent (i.e.,
small systems, large systems, and the
States) incurs an average annual burden
of 9.0 hours and a labor plus non-labor
cost of $2,400. Because the actual
implementation period of the UCMR
does not begin until 2001, most of the
costs presented here occur during that
year. Average annual costs reflect the
fact that the UCMR program
implementation only overlaps with one
of the three ICR years (1999-2001).
The burden and cost per response for
the three ICR years for Assessment
Monitoring are estimated to be 1.7 hour
burden at $35 per response for small
systems; 3.4 hours at $95 for labor and
$2,847 in analytical costs for large
systems; and 52.9 hours at $2,116 for
labor for States. In aggregate, the average
response (i.e., responses from small
systems, large systems, and the States)
is associated with a burden of 8.7 hours,
with a labor plus non-labor cost of
$2,213 per response over the three-year
ICR period.
Over the ICR period, the Agency is
estimated to incur an annual burden of
9,150 hours, with an average annual
cost for labor of $366,000. Non-labor
costs for EPA, which are primarily
comprised of the analytical and
shipping costs for representative set of
small systems, and other contractor
costs, are estimated at $1.3 million per
year over the period 1999-2001. Non-
labor costs are primarily attributed to
the cost of sample testing for small
systems.
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 on its ICR. The OMB
control numbers for EPA's regulations
are listed in 40 CFR Part 9 and 48 CFR
Chapter 15. EPAls amending the table
in 40 CFR Part 9 of currently approved
ICR control numbers issued by OMB for
various regulations to list the
information requirements contained in
the final rule.
E. Regulatory Flexibility Act
Under the Regulatory Flexibility Act
(RFA), 5 U.S.C. 601 et seq., as amended
by the Small Business Regulatory
Enforcement Fairness Act (SBREFA),
EPA generally is required to conduct a
regulatory flexibility analysis describing
the impact of the regulatory action on
small entities as part of rulemaking.
However, under section 605 (b) of the
RFA, if EPA certifies that the rule will
not have a significant economic impact
on a substantial number of small
entities, the Agency is not required to
prepare a regulatory flexibility analysis.
Pursuant to RFA section 605(b), 5 U.S.C.
605 (b) and for the reasons set forth
below, I certify that this rule will not
have a significant economic impact on
a substantial number of small entities.
For purposes of RFA analyses for
SDWA rulemakings, the Agency defines
small entities as systems serving 10,000
or fewer customers because this is the
size of system specified in SDWA as
requiring special consideration with
respect to small system flexibility. This
alternative definition was established
for all drinking water rules in the
Consumer Confidence Reports
rulemaking (63 FR 44511-44536
[August 19, 1998]). EPA also consulted
with the Small Business Administration
about the alternative definition as it
relates to small businesses. For further
information on the establishment of this
definition of small entities, see the
referenced Federal Register notice.
EPA has determined that the UCMR
will affect small water utilities, since it
is applicable to a subset of small
community and non-transient
noncommunity water systems.
However, the affected systems are
limited to a representative sample of
approximately 800 small PWSs, or 1.2
percent of systems serving 10,000 or
fewer persons. These systems will be
required to conduct monitoring, as
specified in the UCMR (i.e., collect and
prepare samples for shipping), EPA will
assume all costs for testing of the
samples and for shipping the samples
from these systems to certified
laboratories throughout the United
States. EPA has set aside $2 million
from the DWSRF in Fiscal Years 1998
and 1999, and plans to do so into the
future with its authority to set aside
DWSRF monies to implement this
SDWA provision.
EPA has estimated the impact of
today's rule and concludes that the rule
will not have a significant economic
impact on a substantial number of small
entities. The rationale for this
conclusion is that EPA plans to pay the
full costs of shipping and testing
samples for small systems and does not
plan, under any scenario, to ask systems
to pay these costs. (The costs to these
systems will be limited to the labor
hours associated with collecting a
sample and preparing it for shipping.)
EPA evaluated the cost to small
entities under two scenarios. Under
either scenario, EPA will assume the
cost of shipping and testing samples for
small systems. The "full
implementation" scenario assumes full
funding from the DWSRF set-aside
through the year 2005, with the full
Assessment Monitoring program being
implemented. The "limited
implementation" scenario assumes that
EPA will pay for testing with the funds
already set aside for this program.
Under either scenario, this rule will not
have a significant economic impact on
a substantial number of small entities,
and EPA certifies that fact. Cost
summaries for both scenarios are
provided below.
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50604 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
1, Full Assessment jyionitoring
Implementation Scenario
EPA analyzed separately the impact
prii small privately and publicly owned
water systems because of the different
^cbnonilc characteristics of these
ownership types. For publicly owned
systems, EPA used the "revenue test,"
which compares a system's annual costs
attributed to the rule with 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
national representative sample of 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 Table 5.
„ 1,4
TABLE 5.—NUMBER OF PUBLICLY AND PRIVATELY OWNED SYSTEMS To PARTICIPATE IN ASSESSMENT MONITORING
"
'"' , 'W' > W % :".,. ' •, 'V '• '!"
Size category
Ground Water Systems:
500 and under
501 to 3,300
3,301 to 10,000
Subtotal
i( Surface 'water Systems:
§00 ""and" ""under
501(63300 . ....
3,301 to 10,000
Subtotal
Total
Publicly owned systems
Non-index
systems
20
146
144
310
18
51
106
175
485
Index systems
1
6
7
14
0
2
5
7
21
Privately owned systems
Non-index
systems
76
67
40
183
49
23
30
102
285
Index systems
2
3
2
7
0
1
1
2
9
Total— all
systems
99
222
193
514
67
77
142
286
800
;!••; "f11! ,
'! V i
ir;
certification under full Assessment
Monitoring program implementation is
as follows: the average annual
compliance costs of the rule represent
less than 1 percent of revenues/sales for
the 800 small water systems that will be
affected. The EPA estimates that EPA
and system costs for implementing
small system sampling for the full
LfcMR Assessment Monitoring program
(2001-2005) will be approximately
$10.2 million. Since the Agency
specifically structured the rule to avoid
significantly affecting a substantial
number of small entities by assuming all
costs for laboratory analyses, shipping,
and quality control for small entities,
EPA costs comprise approximately 99
percent ($10.1 million) of the total costs.
ONtote that EPA's contribution to the
small system program is assumed to
include all small system analytical and
shipping costs, as well as all non-labor
program support costs.) Table 6 presents
the annual costs to small systems and to
EPA for the small system sampling
program, along with the number of
participating small systems during each
of the 5 years of the program.
TABLE 6.—EPA COSTS FOR SMALL SYSTEMS UNDER FULL IMPLEMENTATION OF UCMR ASSESSMENT MONITORING
., 1, \ , , .Cost description 1
Costs to, EPA for Small System Program: quality
assurance, ongoing coordination, data anal-
ysis, analytical costs, shipping costs, and
costs for contractor site visits to small Index
systems2
Costs to Small Systems: additional labor for
monitoring or monitoring assistance
Total Costs to EPA and Small
Systems for UCMR "."1.
Number gf Systems to be Monitoring each Yean
Non-Index and Index in 2001-2003, Index
;;,:, bnJy in 2004-20053
Public "...
Private
Total
2001
$3,317,970
26,796
3,924,769
182
104
286
2002
$2,647,790
25,840
2,993,810
182
104
286
2003
$2,617,790
25,840
3,053,630
182
104
286
2004
i
$856,890
1,861
1,338,752
107
81
188
2005
$648,440
1,861
1,150,297
21
9
30
Total
$10,088,880
82,198
10,171,078
533
267
800
i'. *
1 AM = Assessment Monitoring.
8 EPA POSJS during the year 2001 include some start-up costs that may actually be incurred during the year 2000.
''Toted number "of systems is 800. All 30 Index systems sample during each year 2001-2005. One-third of Non-Index systems sample during
each year from 2001-2003. The rows do not add across, because the same 30 Index systems sample during every year of 5-year implementa-
tion cycle.
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Federal Register/Vol. 64. No. 180/Friday. September 17, 1999/Rules and Regulations 50605
System costs are attributed to the
labor required for reading State
notification letters, monitoring,
reporting, and record keeping.
Assuming that systems will efficiently
conduct UCMR sampling (e.g.,
coincident with other required
monitoring when feasible), the
estimated average annual per system
labor burden for full Assessment
Monitoring implementation will be $17
(0.8 hours) for ground water systems
and $27 (1.3 hours) for surface water
systems. In total, ground water and
surface water systems average 1.0 hours
of burden per year with an average
annual cost of $21. Average annual cost,
in all cases, is less than 0.2 percent of
system revenues/sales. Therefore, as
stated previously, the Administrator
certifies that this rule, as funded by
EPA, will not have a significant
economic impact on small entities.
Tables 7a and 7b below present the
estimated economic impacts in the form
of revenue/sales tests for publicly and
privately owned systems.
TABLE 7a.—UCMR FULL ASSESSMENT MONITORING IMPLEMENTATION SCENARIO: ANALYSIS FOR PUBLICLY-OWNED
SYSTEMS (2001-2005)
System size
Annual number of
systems affected 1
Number
Percent of
US total
Average annual hours
per system
(2001-2005)
Non-index
Index
Average annual cost per
system
Non-index
Index
"Revenue test"2
(percent)
Non-index
Index
Ground Water Systems
500 and under
501 to 3,300
3,301 to 10,000
4.8
35.4
35.8
0.01
0.29
1 49
06
07
09
20
-28
36
$903
10 12
2402
$28 28
39 88
10080
005
001
001
0 17
004
002
Surface Water Systems
500 and under
501 to 3,300
3,301 to 10,000
3.5
12.2
25.9
0.18
0.67
258
1 1
1 2
1 2
00
42
40
1639
1803
3324
000
6090
112 00
006
001
0 00
000
003
002
1 Calculated as Vs of the Non-Index sample, plus all Index systems for each year from 2001-2005; actual sampling for Non-Index systems
takes place over three years, while that of Index systems occurs over each of five years.
2The "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.
TABLE 7b.—UCMR FULL ASSESSMENT MONITORING IMPLEMENTATION SCENARIO: ANALYSIS FOR PRIVATELY-OWNED
SYSTEMS (2001-2005)
System size
Annual number of
systems affected 1
Number
Percent of
US total
Average annual hours
per system
(2001-2005)
Non-index
Index
Average anr
sys
Non-index
lual cost per
tern
2005) 1
Index
"Sales test"2
(percent)
Non-index
Index
Ground Water Systems
500 and under
501 to 3,300
3,301 to 10,000
17.6
16.2
10.1
0.04
0.13
0.42
0.6
0.7
09
20
28
36
$903
10 12
2402
$2828
39 88
10080
006
001
000
0 18
004
002
Surface Water Systems
500 and under
501 to 3 300
3,301 to 10,000 .".
97
56
7.3
051
031
0.72
1 1
1 2
1 2
0 0
42
40
16 39
18 03
3324
0 00
60 90
11200
0 07
0 01
001
000
004
002
1 Calculated as Vs of the Non-Index sample, plus all Index systems for each year from 2001-2005; actual sampling for Non-Index systems
takes place over three years, while that of Index systems occurs over each of five years.
2The "Sales Test" was used to evaluate the economic impact of an information collection on small private entities (e.g., privately-owned sys-
tems); costs are presented as a percentage of median annual sales in each size category.
2. Limited Implementation Scenario
Despite the expected $2 million
annual budget, EPA recognizes that
funding levels vary from year to year
and thus the Agency cannot guarantee
the precise amount that will ultimately
be available to implement its UCMR
Assessment Monitoring Program
(although a considerable portion of
those funds are currently on hand). If an
amount commensurate with funding the
optimal UCMR Assessment Monitoring
Program (in terms of numbers of small
systems sampled and numbers of
contaminants analyzed) is not available,
the Agency will adjust the UCMR
program to accommodate the available
funds. This adjustment may necessitate
use of fewer sample sites, testing for
fewer contaminants, or both.
Although the Agency considers the
scenario of no additional funding to be
unlikely, EPA also evaluated the
scenario of "current funds only" for
purposes of this RFA analysis. In this
"current available funds" scenario EPA
would receive no funding for small
system testing beyond the $4 million set
aside from the DWSRF in FY 1998 and
FY 1999. EPA anticipates funding this
program such that no small system
would incur testing costs, as intended in
the legislation. Small systems would be
responsible only for taking the sample.
By analyzing the small system impact
under this scenario, EPA can
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:f I
5060Q FederalRegister/Vol. 64, No. 180/Friday, September 17, 1999/Rules and Regulations
demonstrate that, regardless of funding
levels, the pCMR will not have a
significant economic impact on a
substantial number of small entities.
Given the flexibility of the proposed
rule, EPA can ensure scientifically
defensible results, balanced with
available funding.
In the optimal program, the sample of
800 systems is derived by applying a 99
percent confidence level, with 1 percent
error tolerance. To accommodate a $4
million budget, the representative
sample of small systems would be
Deduced to approximately 400 systems.
Although this smaller sample would be
less rigorous than the anticipated
sample of 800 systems, the sample error
would still remain within plus or minus
5 percent. These 400 systems would
Incur only labor costs for collecting and
.. . .. >
packing the samples, while EPA would
pay to ship and test these samples.
With the currently available $4
million, EPA will be able to fund
approximately 50 percent of the
planned Assessment Monitoring
program for small systems. To estimate
the costs under this scenario, EPA
assumed that only the Assessment
Monitoring component of the UCMR
would be implemented and that the
smaller representative sample would be
allocated across system size categories
in the same proportions as those in the
sample of 800 systems, with 10 of these
systems being Index sites, as seen in
Table 8. Finally, for the cost analysis of
this current funds scenario, EPA
assumed that the national representative
sample will reflect the proportions of
publicly and privately owned systems
in the national inventory of public water
systems.1 Because EPA's statistical
approach uses a random selection
process for systems in the national
representative sample, publicly-and
privately-owned systems should be
selected in the same proportions for that
sample as they occur in the set of all
community and non-transient non-
community water systems in the nation.
The Agency is concerned that a
reduced sample size will reduce the
statistical likelihood that the observed
contaminant occurrence levels will be
representative of actual occurrence
across the nation. Because of this, the
Agency will actively pursue funding for
the full program described in this
Preamble.
Table 8.—Number of Publicly- and Privately-Owned Systems To Participate in Assessment Monitoring, for Limited
Funding Program1
I 'I, ' , I ' P :i ; :„„! , i,
"', ' . : I - ,111
Size category
Ground iyater Systems:
500 and under
501 to 3,300 '..
3,301 to 10,000 ...
Subtotal ground water systems
•' i " " :; ., "I' -I'l' ' " 'j '• • !
Surface Water Systems:
500 and under
501 to 3,300
3,301 to 10,000 ..I. '..
Subtotal surface water systems
Total „: ;....".
Publicly-owned systems
Non-index
systems
10
75
73
158
9
26
54
89
247
Index systems
0
2
2
4
0
1
2
3
7
Privately-owned systems
Non-index
systems
39
34
21
94
24
12
15
51
145
Index systems
1
1
1
3
0
0
0
0
3
Total— all
systems
50
112
97
259
33
39
71
143
402
1 The Limited Funding Program assumes that the only funds available to run the program are those that are currently in hand—$4 million of set
aside funds from Federal pssaj Years 1998, and 1999. This is a "worst case" funding scenario.
Under the limited fjinding scenario,
EPA's costs for Assessment Monitoring
would be incurred primarily from 2001
to 2003. Systems are assumed to sample
during 1 year of the 3-year period, with
one-third of systems sampling during
each year. However, Index Systems are
assumed to monitor during each of the
I
three Assessment Monitoring years. The
distribution of costs to EPA and small
systems over the entire 5 years is
presented in Table 9.
; ,"" I ,| , , .. ,,, ' ; 'jij,
TABLE 9.—EPA dosTS FOR SMALL SYSTEMS—LIMITED' $4 MiLLioN PROGRAM
' I
Cost description
> . •• . t; : , 'jn •.-.•}., : .; " i.:
Costs to EPA for Assessment Monitoring Pro-
gram: Quality assurance, ongoing coordina-
tion, data analysis, shipping costs, testing
costs, reporting and analysis costs, and costs
;'* | ^ ;i for"conjractqr site visits to "Index" systems ....
Costs tq "Small" "Systems (Assessment Moni-
toring}: Including additional labor for moni-
toring or monitoring assistance
2001
$1,367,947
13,162
2002
$1,082,342
11,527
2003
$1,082,342
11,527
2004
$280,422
0
2005
$186,948
0
Total
$4,000,000
36,216
I'll
r'ill'
1 Publicly- and privately-owneS systems
allocations are estimated using data from the 1995
Community Water System Survey. Publicly-owned
systems are those that are owned by a city, town,
township, village, municipal government, State or
federal government, or any other publicly-owned or
operated system. Privately-owned systems include
those owned by private investors or homeowners'
associations.
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Federal Register/Vol. 64. No. ISO/Friday. September 17. 1999/Rules and Regulations 50607
TABLE 9.—EPA COSTS FOR SMALL SYSTEMS—LIMITED $4 MILLION PROGRAM—Continued
Cost description
Total Costs to EPA and Small Systems
for Assessment Monitoring
Number of Systems each Yean Assessment
Monitoring and Index Systems in 2001-
2003:1
Public
Private
Total
2001
1 381 109
89
51
140
2002
1 093 869
89
51
140
2003
1 093 869
RQ
51
140
2004
yon 400
2005
E 1 flfi Q/lft
Total
A riQft 01 C
1Aft
1 Rows do not add across because the 10 Index systems sample during each year 2001-2003. One-third of Non-Index systems sample during
each year from 2001-2003. a
Under this limited $4 million
program, EPA's costs represent
approximately 98 percent of the
national cost for the small system
sampling program. As in full UCMR
implementation, small system costs are
attributed to the additional labor
required for reading State letters,
monitoring, reporting, and record
keeping. It is estimated that under a
limited program of Assessment
Monitoring only the average annual per
system labor burden will be $14 (0.7
hours) for ground water systems and
$25 (1.2 hours) for surface water
systems. In total, ground water and
surface water systems average 0.9 hours
of burden per year, with an average
annual cost of $ 18.
Through revenue and sales tests,
determinations of economic impact are
presented in Tables lOa and lOb
respectively. Under this limited $4
million program, systems will be subject
to less required monitoring than in the
full UCMR program. For both full
Assessment Monitoring implementation
and the limited funding scenario,
average annual cost is in all cases lower
than 1 percent of annual sales/revenues.
Thus, even in this worst case, limited
implementation scenario, EPA certifies
that today's final rule would not impose
a significant economic impact on small
entities.
TABLE 10a.—UCMR LIMITED IMPLEMENTATION SCENARIO: ANALYSIS FOR PUBLICLY-OWNED SYSTEMS (2001-2005)
System size
Annual number of
systems affected 1
Number
Percent of
US total
Average annual hours
per system
(2001-2005)
Non-index
Index
Average annual cost per
system
(2001-2005)
Non-index
Index
"Revenue test"2
(percent)
Non-Index
Index
Ground Water Systems
500 and under
501 to 3,300
3,301 to 10 000 ...
2 1
16.2
16 1
000
0 13
0 67
0 6
06
0 8
1 3
1 5
9 ft
n AH
Surface Water Systems
500 and under
501 to 3,300
3,301 to 10,000
1 7
5.6
11.8
009
031
1 17
1 •)
1 2
1 1
0 0
2 6
25
1S 4.1
1707
31 35
n nn
^R 9R
70 56
n n^
n m
0 00
n nn
n 09
n ni
1 Calculated as Vs of publicly-owned Non-Index sample, plus all public Index systems for each year from 2001-2003; actual sampling for Non-
Index takes place over 3 years, Index in each of 3 years.
2The "Revenue Test" was used to evaluate the economic impact of an information collection on small governments (e.g., publicly owned sys-
tems); costs are presented as a percentage of median annual revenue in each size category.
TABLE 10b.—UCMR Limited Implementation Scenario: Analysis for Privately-Owned Systems (2001-2005)
System size
Annual number of
systems affected 1
Number
Percent of
US total
Average annual hours
per system
f9nm onnc\
Non-index
Index
Average annual cost per
system
Non-index
Index
"Revenue test" 2
(percent)
Non-index
Index
Ground Water Systems
500 and under
501 to 3,300
3,301 to 10,000
8.2
74
4.5
002
006
0 19
06
0 6
08
1 3
1 5
20
$806
9 15
22 16
$18 71
22 19
57 12
0 05
0 01
0 00
0 12
n 09
0 01
Surface Water Systems
500 and under
501 to 3.300
48
2.5
0.25
0.14
1 1
1.2
0 0
2.6
1541
17 f)7
0 00
3R9R
n ny
nn-i
n nn
n na
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50608 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
. | ~
TABLE 10b.—UCMR Limited Implementation Scenario: Analysis for Privately-Owned Systems (2001-2005)—
Continued
System size
i ' '•! „ 'mil
asoi to 10.000 .'. 1.......
Annual number of
systems affected 1
Number
3.3
Percent of
US total
0.33
Average annual hours
per system
(2001-2005)
Non-index
1.1
Index
2.5
Average annual cost per
system
(2001-2005)
Non-index
31.35
Index
70.56
"Revenue test"2
(percent)
Non-index
0.01
Index
0.01
i Calculated as Vfe of the Non-Index sample, plus all Index systems for each year from 2001-2005; actual sampling for Non-Index systems
takes place over 3 years, while that of Index systems occurs during each of 3 years.
*The "Sales Test" was used to evaluate the economic impact of an information collection on small private entities (e.g., privately owned sys-
tems); costs are presented as a percentage of median annual sales in each size category.
' i,
i I;
1,1 ;•
•'in
F. National Technology Transfer and
Advancement Act
As noted in the proposed rule.
Section 12(d) of the National
Technology Transfer and Advancement
Act (NTTAA), Pub. L. No. 104-113,
S 12(d) (15 U.S.C. 272 note) directs EPA
to use voluntary consensus standards in
Its regulatory activities unless to do so
W^uld bg inconsistent wtth 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
iiandards bodies. The NTTAA directs
EPA to provide Congress, through OMB,
explanations when the Agency decides
riot to use available and applicable
voluntary consensus standards.
This rjilemaking involves technical
standards. EPA has decided to use
consensus methods published by the
three major voluntary consensus
method organizations—Standard
Methods, AOAC International, and
American Society for Testing and
Materials (ASTM)—that would be
acceptable for compliance
determinations under SDWA for the
UCMR (1999) List 1. The voluntary
consensus methods found are listed in
S 141.40(a)(3), Table 1. List 1. For the
Assessment Monitoring portion of the
final rule, EPA is approving the use of
all of the non-EPA analytical methods
adopted by these voluntary consensus
groups that are applicable to the
analyses of these unregulated
contaminants when used in conjunction
with the required quality-control
practices specified in the rule.
A, few public comments suggested the
updating of consensus methods
approved in Table 1, List 1, or an
additional method to consider. To that
end, the Agency updated the consensus
methods listed to include those
Identified in the most current (20tti)
edition of"Standard Methods (SM). SM
6200B, from the 20th edition, is also
approved for volatile analysis; SM
6210D remains on the list but only
appears in previous editions. A
commeriter suggested use of SM 6640
for DCPA mono and di acids for List 1;
however, this method does not address
hydrolysis, a critical step in the analyses
of this contaminant, so EPA is nor
including it on the list.
EPA conducted a search to identify
potentially applicable voluntary
consensus standards for chemical and
microbiological parameters included in
Lists 2 and 3 of this rule. EPA identified
and listed in the proposal some general
methods specifications that the Agency
believes may potentially be used to
reliably detect some of the contaminants
on List 2. However, EPA was unable to
find either an EPA or voluntary
consensus method applicable to the
monitoring required and none were
brought to our attention in comments on
the proposed rule. Commenters
suggested EPA also approve EPA
Method 632 for linuron and diuron,
which does not include confirmation or
preservation steps; and EPA Method 552
for the phenols, which has low
recoveries and interferences among the
compounds. For these reasons, EPA has
not included these EPA methods for the
respective contaminants. No other
voluntary consensus standards were
brought to the Agency's attention in
comments on the proposed rule. EPA is
developing acceptable methods to
determine the presence of the
contaminants on Lists 2 and 3, and will
take additional public comment when
the rules are proposed for monitoring of
List 2 and 3 contaminants.
G. 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, the
unregulated contaminant monitoring
regulation 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 national representative sample that
is population-weighted within each
system size category allocated across
States, the final rule ensures that no
group within the population is under
represented.
H. Federalism Executive Orders
Under Executive Order 12875, EPA
may not issue a regulation that is not
required by statute and that creates a
mandate upon a State, local, or tribal
government, unless the Federal
government provides the funds
necessary to pay the direct compliance
costs incurred by those governments, or
EPA consults with those governments. If
EPA complies by consulting, Executive
Order 12875 requires EPA to provide to
OMB with a description of the extent of
EPA's prior consultation with
representatives of affected State, local,
and tribal governments; the nature of
their concerns; any written
communications from the governments;
and a statement supporting the need to
issue the regulation. In addition,
Executive Order 12875 requires EPA to
develop an effective process permitting
elected officials and other
representatives of State, local, and tribal
governments "to provide meaningful
and timely input in the development of
regulatory proposals containing
significant unfunded mandates."
EPA has concluded that today's rule
will create a mandate on local
governments that own or operate PWSs
and that the Federal government will
not provide the funds necessary to pay
all of the direct costs incurred by these
governments in complying with the
mandate. However, EPA will pay for the
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Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations 5OGO9
sample testing costs of small systems
and has budgeted funds to do so.
In developing this rule, EPA
consulted with State, local, and tribal
governments to enable them to provide
meaningful and timely input in the
development of this rule. Prior to the
publication of the proposed rule, EPA
received input through its public
stakeholder process, by conducting
public meetings and through targeted
mailings. Additionally, EPA received
input through its public comment
process from 22 States, 13 public water
systems and local water agencies, and
130 other commenters, including non-
profit organizations, associations,
industry, and individuals. EPA also sent
out nearly 400 targeted mailings directly
to 360 Tribes, Tribal organizations, and
small water system organizations to
ensure that they were informed of the
proposed rule's publication and had an
opportunity to comment. The principal
concerns raised were that: (1) States did
not want to go through the primacy
process; (2) EPA should include
perchlorate on the monitoring list; (3)
EPA should use multi-analyte methods
to the extent possible for testing; and (4)
EPA should allow previous monitoring
data for some of the contaminants on
the list. In response to these principal
concerns, EPA changed the
implementation steps for the regulation
from primacy revisions to a
Memorandum of Agreement with States.
Perchlorate is now on UCMR List 1
(1999) for early monitoring. EPA
incorporated as many additional
contaminants in List 1 using multi-
analyte methods as possible, specifically
moving acetochlor from List 2 to List I.
Systems can submit previously
collected data to meet the UCMR, as
long as the requirements for sampling,
testing and reporting are met.
Finally, while there is a new
executive order on federalism,
Executive Order 13132, it will not go
into effect until November 3, 1999. In
the interim, under the current Executive
Order 12612 on federalism, this rule
does not have a substantial direct effect
upon States, upon the relationship
between the national government and
the States, or upon the distribution of
power and responsibilities among the
various levels of government. The final
rule allows States to decide whether
they want to enter a Memorandum of
Agreement (MOA) with EPA to
implement the monitoring program. If
they decide not to enter into an MOA,
then EPA will directly implement the
monitoring program, since the data are
for the purposes of deciding which
contaminants to regulate in the future at
the Federal level and will not have a
direct effect on public health protection
under current drinking water standards
implemented by States.
I. Executive Order 13084—Consultation
and Coordination with Indian Tribal
Governments
Under Executive Order 13084, EPA
may not issue a regulation that is not
required by statute, that significantly or
uniquely affects the communities of
Indian Tribal governments, and that
imposes substantial direct compliance
costs on those communities, unless the
Federal government provides the funds
necessary to pay the direct compliance
costs incurred by the Tribal
governments, or EPA consults with
those governments. If EPA complies by
consulting, Executive Order 13084
requires EPA to provide to OMB, in a
separately identified section of the
preamble to the rule, a description of
the extent of EPA's prior consultation
with representatives of affected Tribal
governments, a summary of the nature
of their concerns, and a statement
supporting the need to issue the
regulation. In addition, Executive Order
13084 requires EPA to develop an
effective process permitting elected
officials and other representatives of
Indian Tribal governments "to provide
meaningful and timely input in the
development of regulatory policies on
matters that significantly or uniquely
affect their communities.''
Today's rule does not significantly or
uniquely affect the communities of
Indian Tribal governments. Only one
Tribal water system serves more than
10,000 persons. All the other Tribal
water systems serve 10,000 or fewer
persons, and in today's rule have an
equal probability of being selected in
the national representative sample of
small systems, for which EPA will pay
the costs of unregulated contaminant
testing. Thus, these Tribal water systems
will be treated the same as water
systems of a State and the impact of the
rule on them will not be significant.
This rule will not impose substantial
direct compliance costs on such
communities either because, with the
exception of the one large Tribal water
system, the Federal government will
provide most of the funds necessary to
pay the direct costs incurred by tribal
governments in complying with the
rule. Accordingly, the requirements of
section 3(b) of Executive Order 13084
do not apply to this rule. Nevertheless,
in developing this rule, EPA consulted
with representatives of Tribal
governments pursuant to both Executive
Order 12875 and Executive Order
13084. The extent of EPA's consultation,
the nature of the governments' concerns,
and EPA's position supporting the need
for this rule, are discussed in the
preamble section that addresses
compliance with Executive Order '
12875. Tribes were consulted and raised
issues concerning the utility of a
targeted, rather than a representative
random, sampling approach and the
applicability of "treatment as a State"
under the final rule.
/. Concessional Review Act
The Congressional Review Act, 5
U.S.C. §801 etseq., as added by the
Small Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a "major rule" as
defined by U.S.C. § 804(2). This rule
will be effective January 1, 2001.
XTTT. 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 to provide early
input to regulation development.
Activities related to the UCMR included
meetings for developing the CCL and
the information requirements of the
NCOD, as well as specific meetings
focused on revising the UCMR
monitoring list. During the development
of the UCMR, stakeholders from a wide
range of public and private entities
provided key perspectives.
Representatives from public water
systems, States, industry, and other
organizations attended two stakeholder
meetings to discuss options directly
related to the UCMR. An additional 17
meetings were held with stakeholders
and the public concerning issues related
to the UCMR. In total, 21 State health
and environmental agencies, 5 water
systems, 6 water associations, 6 health
associations, 5 industrial associations, 4
environmental organizations, 4
community and consumer
organizations, 29 companies, and 7
federal agency offices participated in
meetings that were instrumental in the
development of today's final rule.
As noted previously, the CCL
identifies contaminants for which EPA
-------
50610 F?der£|l Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
may taie regulatory action and for
which EPA needs additional data. The
UCMR list contains contaminants for
Which additional data are needed before
EPA can determine their regulatory
status. The meetings to develop the CCL
included stakeholder meetings to
discuss the list broadly and meetings
focused on particular issues conducted
through the National Drinking Water
Advisory Council's (NDWAC) Working
Group on Occurrence and Contaminant
Selection, as follows:
• December 2-3. 1996 Stakeholders
Meeting!
• April 3-4,1997 NDWAC Working
Group.
« June 23.1997 NDWAC Working
Group.
• July 17,1997 NDWAC Working
Group.
• January 7.1998 NDWAC
Conference Call.
These meetings resulted in the
Drinking Water Contaminant Candidate
List (63 FR 10274, March 2,1998). The
cpnlaminante in today's rule for
unregulated contaminant monitoring are
taken in large part from the CCL
"Occurrence Priorities."
The ISfCOD development activities
Included 10 public meetings on
Information requirements that should be
considered for inclusion in the database.
These meetings were held between
October 1997 and February 1998. The
i&ofk of the NCOD development team is
incorporated as the reporting
requirements for sample testing in
today's unregulated contaminant
monitoring regulation. Several
documents concerning the NCOD
development which were used in the
public meetings are:
• Options for the National Drinking
Water Contaminant Occurrence Data
Base, Background Document (Working
Draft), EPA 815-D-97-001, May 1997.
• National Drinking Water
Contaminant Occurrence Data Base—
Development Strategy, Background
Document (Working Draft), EPA 815-D-
97-005, December 1997.
• Options for Design of the National
Drinking Water Contaminant
Occurrence Data Base. Background
Document (Working D'raft), EPA 815-D-
98-00 IT January 1998.
EPA held its first stakeholder meeting
to discuss options for the development
of the IJnregulated Contaminant
Monitoring Regulation on December 2
and 3,1997, in Washington, DC. A
variety of stakeholders attended that
meeting, including representatives of
jPWSs. States, industry, health and
laboratory organizations, and the public.
EPA prepared a background document
for the meeting. Options for Developing
the Unregulated Contaminant
Monitoring Regulation (Working Draft),
EPA 815-P-97-003, November 1997. A
summary of the meeting is also
available. EPA held a second
stakeholders meeting on June 3 and 4,
1998 to obtain input from interested
parties on significant issues evolving
from drafting the regulation, which
needed further public input. The
Agency prepared a public review
document for that meeting, Background
Information and Draft Annotated
Outline for a Proposed Unregulated
Contaminant Monitoring Regulation,
Background Document, (Working Draft),
May 1998. A meeting summary also is
available. EPA also sent special requests
for review of stakeholder documents to
more than 360 Tribes (exclusive of the
Alaskan native villages) and to small
systems organizations to obtain their
input.
In all, EPA held 17 public meetings
with stakeholders and interested parties
related directly or closely to the final
Unregulated Contaminant Monitoring
Regulation. Additionally, EPA received
39 comments by the public comment
date of June 14, 1999, from a range of
the public, including individuals, water
systems, States, environmental
organizations, and associations. EPA
also received 121 comments after the
comment period, primarily from
individuals concerned with perchlorate
being on the Monitoring List.
XIV. References
Barbash, J.E., and E.A. Resek. 1996.
Pesticides in Ground Water, volume two of
the series Pesticides in the Hydrologic
System. Ann Arbor Press, Inc., Chelsea,
Michigan.
Battaglin, W., and Hay, L. 1996. Effects of
sampling strategies on estimates of annual
mean herbicide concentrations in
Midwestern rivers. Environmental Science
and Technology, v. 30, p. 889-896.
Hallberg, G. 1989a. Pesticide pollution of
groundwater in the humid United States; In
Bouwer, H., and Bowman, R.S., eds., Effect
of Agriculture on Groundwater. Agriculture,
Ecosystems, and Environment, v. 26, p. 299-
367.
Hallberg, G.R. 1989b. Nitrate in
groundwater in the United States, In Follett,
R.F., ed., Nitrogen Management and
Groundwater Protection; Chapter 3, p. 35-74.
Elsevier Sci. Pub., Amsterdam, The
Netherlands.
Hallberg. G., and D. Keeney. 1993. Nitrate.
In Alley, W.A., Regional Ground-Water
Quality; Chapter 2, p. 297-322. Van Nostrand
Reinhold, New York, NY.
Harada, Koh, W.C. Burnett, P.A. LaRock,
and J.B. Co wart. 1989. Polonium in Florida
groundwater and its possible relationship to
the sulfur cycle and bacteria. Geochemica et
Cosmochimica Acta, v. 53, pp. 143-150.
Havelaar, A.H., M. During and J.F.
Versteegh. 1987. Ampicillin-dextrin agar
medium for the enumeration of Aeromonas
species in water by membrane filtration.
Journal of Applied Bacteriology. 62(3) :279-
287.
Larson, S.J., P.D. Capel, and M.S.
Majewski. 1997. Pesticides in Surface Waters,
volume three of the series Pesticides in the
Hydrologic System. Ann Arbor Press, Inc.,
Chelsea, Michigan.
Newcombe, R.G. 1998. Two-Confidence
Intervals for the Single Proportion:
Comparison of Seven Methods. Statistics in
Medicine, vol. 17, p. 857-872.
Pinsky, P., M. Lorber, K. Johnson, B. Kross,
L. Burmeister, A. Wilkins, and G. Hallberg.
1997. A study of the temporal variability of
atrazine in private well water. Environmental
Monitoring and Assessment, v. 47, p. 197-
221.
Upchurch, S.B. 1991. Radiochemistry of
Uranium-Series Isotopes in Groundwater.
Florida Institute of Phosphate Research
(Report No. 05-022-092).
List of Subjects
40CFRPart9
Environmental protection, Reporting
and recordkeeping requirements.
40 CFR Part 141
Environmental protection, Analytical
methods, Chemicals, Incorporation by
Reference, Intergovernmental relations,
Microorganisms, Monitoring, Water
supply.
40 CFR Part 142
Environmental protection. Analytical
methods, Chemicals, Intergovernmental
relations, Microorganisms, Monitoring,
Water supply.
Dated: August 30, 1999.
Carol M. Browner,
Administrator.
For the reasons set out in the
preamble, title 40 Chapter I of the Code
of Federal Regulations is amended as
follows:
PART 9—OMB APPROVALS UNDER
THE PAPERWORK REDUCTION ACT
1. The authority citation for part 9
continues to read as follows:
Authority: 7 U.S.C. 135 etseq., 136-136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671;
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 etseq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345(d) and
(e); 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g-l, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, SOOj-l,
300J-2, 300J-3, 300J-4, 300J-9, 1857 etseq.,
6901-6992K, 7401-7671q, 7542, 9601-9657,
11023, 11048.
2. Section 9.1 is amended by
removing the entry for "141.33-141.35";
revising the entry for "141.40"; and by
adding in numerical order under the
indicated heading new entries "141.33-
141.34" and "141.35" to read as follows:
-------
Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations 50B11
§ 9.1 OMB approvals under the Paperwork
Reduction Act
40 CFR Citation
OMB control
No.
National Primary Drinking Water
Regulations
141.33-141.34 2040-0090
141.35 2040-0208
141.40 2040-0208
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-l, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, 300J-4,
300J-9, and300j-ll.
2. Section 141.35 is revised to read as
follows:
§ 141.35 Reporting of unregulated
contaminant monitoring results.
(a) Does this reporting apply to me?
(1) This section applies to any owner or
operator of a public water system
required to monitor for unregulated
contaminants under § 141.40. This
section requires you to report the results
of this monitoring.
(2) Exception. You do not need to
report results if you are a system serving
a population of 10,000 or less, since
EPA will arrange for testing and
reporting of the results. However, you
will still need to comply with consumer
confidence reporting and public
notification requirements for these
results.
(b) To whom must I report? You must
report the results of unregulated
contaminant monitoring to EPA and
provide a copy to the State. You must
also notify the public of the monitoring
results as provided in Subpart O
(Consumer Confidence Reports) and
Subpart Q (Public Notification) of this
part.
(c) When must I report monitoring
results? You must report the results of
unregulated contaminant monitoring
within thirty (30) days following the
month in which you received the results
from the laboratory . EPA will place the
data in the national drinking water
contaminant occurrence database sixty
(60) days after you report the data to
allow for quality control review by
systems and States.
(d) What information must I report?
You must report the information
specified in the following table for each
sample, and for each spiked sample and
spike duplicate sample analyzed for
quality control purposes and associated
with each sample and its sample batch:
TABLE 1.—UNREGULATED CONTAMINANT MONITORING REPORTING REQUIREMENTS
Data element
Definition
1. Public Water System (PWS) Identification
Number.
2. Public Water System Facility Identification
Number—Source, Treatment Plant, and Sam-
pling Point.
3. Sample Collection Date
4. Sample Identification Number
5. Contaminant/Parameter.,
6. Analytical Results—Sign
7. Analytical Result—Value
8. Analytical Result—Unit of Measure ,
9. Analytical Method Number
10. Sample Analysis Type
11. Sample Batch Identification Number
12. Detection Level
13. Detection Level Unit of Measure
The code used to identify each PWS. The code begins with the standard two-character postal
State abbreviation; the remaining seven characters are unique to each PWS.
An identification number established by the State, or, at the State's discretion, the PWS, that
is unique to the system for an intake for each source of water, a treatment plant and a sam-
pling point. Within each PWS, each intake, treatment plant and sampling point must receive
a unique identification number, including, for intake; surface water intake, ground water well
or wellfield centroid; and including, for sampling point; entry points to the distribution system,
wellhead, intake, locations within the distribution system, or other representative sampling
point specified by the State. The same identification number must be used consistently
throughout the history of unregulated contaminant monitoring to represent the facility.
The date the sample is collected reported as 4-digit year, 2-digit month, and 2-digit day.
A numeric value assigned by the PWS or laboratory to uniquely identify a specific sampling
occurrence.
The unregulated contaminant or water quality parameter for which the sample is being ana-
lyzed.
An alphanumeric value indicating whether the sample analysis result was:
(a) (<) "less than" means the contaminant was not detected or was detected at a level "less
than" the MRL.
(b) (=) "equal to" means the contaminant was detected at a level "equal to" the value reported
in "Analytical Result—Value."
The actual numeric value of the analysis for chemical and microbiological results, or the min-
imum reporting level (MRL) if the analytical result is less than the specified contaminant's
MRL
The unit of measurement for the analytical results reported, [e.g., micrograms per liter, (ng/L);
colony-forming units per milliliter, (CFU/mL), etc.]
The identification number of the analytical method used.
The type of sample collected. Permitted values include:
(a) Reid Sample—sample collected and submitted for analysis under this rule.
(b) Batch Spike/Spike Duplicate—Samples associated with a batch used for calculating analyt-
ical precision and accuracy. A batch is defined as the set of field samples plus one spiked
sample and one spiked duplicate sample analyzed for contaminant concentrations
A number assigned by the laboratory to the batch of samples analyzed with the spiked sample
(at the spiking concentration reported), to be reported as 9-digit laboratory number (as-
signed by the State or EPA), 4-digit year, 2-digit month, 2-digit day and 2-digit batch num-
ber.
"Detection level" refers to the detection limit applied to both the method and equipment. De-
tection limit is the lowest concentration of a target contaminant that a given method or piece
of equipment can reliably ascertain and report as greater than zero ( e.g., Instrument Detec-
tion Limit, Method Detection Limit, or Estimated Detection Limit).
The unit of measure to express the concentration, count, or other value of a contaminant level
for the detection level reported.
(e.g., p.g/L, colony forming units/mL (CFU/mL), etc.)
-------
f is:
unit
.. .
50612 Federal Register/Vol. 64, No. 180/Friday, September 17, 1999/Rules and Regulations
TABLE |:—UNREGULATED CONTAMINANT MONITORING REPORTING REQUIREMENTS—Continued
Data element
Definition
14. Analytical Precision
15. Analytical Accuracy
16. Spiking Concentration
17. Presence/Absence .....'.
Precision is the degree of agreement among a set of repeated measurements and is mon-
itored through the use of replicate samples or measurements. For purposes of the Unregu-
lated Contaminant Monitoring Regulation (UCMR), Analytical Precision is defined as the rel-
ative percent difference (RPD) between spiked matrix duplicates. The RPD for the spiked
matrix duplicates analyzed in the same batch of samples as the analytical result being re-
ported is to be entered in this field. Precision is calculated as Relative Percent Difference
(RPD) between spiked matrix duplicates using,
RPD = [(Xi-X2) / (Xt + X2)/a] x 100
Accuracy describes how close a result is to the true value measured through the use of
spikes, standards, surrogates or performance evaluation samples. For purposes of unregu-
lated contaminant monitoring, accuracy is defined as the percent recovery of the contami-
nant in the spiked matrix sample analyzed in the same analytical batch as the sample result
being reported and calculated using;
% recovery = [(amt. found in spiked sample—amt. found in sample) / amt. spiked] x 100
The concentration of method analytes added to a sample to be analyzed for calculating analyt-
ical precision and accuracy where the value reported use the same unit of measure reported
for Analytical Results
Chemicals: Presence—a response was produced by the analysis (i.e., greater than or equal to
the MDL but less than the MRL)/Absence—no response was produced by the analysis (i.e.,
less than the MDL).
Microbiologtcals: Presence—indicates a response was produced by the analysis /Absence—in-
dicates no response was produced by the analysis.
(e) How must f report this
information? You must report this
information in the electronic or other
format specified by EPA.
(f) Can the laboratory to which I send
samples report the results for me? Yes,
as long as the laboratory sends you a
copy for review and recordkeeping.
jioweve£, you are responsible for the
reporting of this information and
insuring that the laboratory reports
these results to EPA, with a copy to the
State, on time.
(g) Can /report previously collected
data to i^eet the testing and reporting
requirements for the contaminants
listed in § 14L40(a)(3)?Yes, as long as
the data, meet the specific requirements
of § I4i.40(a)(3), (4), (5), and Appendix
A of § 14 1 .40 and you report the data
with the information specified in
paragraph (d) of this section.
3. Section 141,40 is revised to read as
follows:
,„ :, tffti ' ''' i nl ..... p'f i, ' " iiiit:1 i .. ' • , t' -'IN
§141.40 Monitoring requirements for
Unregulated contaminants.
(a) Requirements for owners and
operators of public water systems. (1) Do
I have to monitor for unregulated
(i) Transient systems. If you own or
djDerate a transient non:comrriuhity
water system, you do not have to
iirjonitor for unregulated contaminants.
(li) Large systems not purchasing their
entire water supply from another
system, tf you own or operate a
wholesale or retail public water system
(other than a transient system) that
serves more than 10,000 persons, as
determined by the State, and do not
purchase your entire water supply from
another public water system, you must
monitor as follows:
(A) You must monitor for the
unregulated contaminants on List 1 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999)'List, in
paragraph (a) (3) of this section.
(B) You must monitor for the
unregulated contaminants on List 2 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, if
notified by your State or EPA that you
are part of the Screening Surveys.
(C) You must monitor for the
unregulated contaminants on List 3 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, if
notified by your State or EPA that you
are part of the Pre-Screen Testing.
(iii) Large systems purchasing their
entire water supply from another
'system. If you own or operate a public
water system (other than a transient
system) that serves more than 10,000
persons and purchase your entire water
supply from a wholesale public water
system, you must monitor as follows:
(A) You must monitor for the
unregulated contaminants on List 1 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, that
have a "sampling location" indicated as
"distribution system".
(B) You must monitor for the
unregulated contaminants on List 2 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, that
have a "sampling location" indicated as
"distribution system" if notified by your
State or EPA that you are part of the
Screening Surveys.
(C) You must monitor for the
unregulated contaminants on List 3 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, that
have a "sampling location" indicated as
"distribution system" if notified by your
State or EPA that you are part of the Pre-
Screen Testing.
(iv) Small systems not purchasing
their entire water supply from another
system. If you own or operate a public
water system (other than a transient
system) that serves 10,000 or fewer
persons and do not purchase your entire
water supply from another public water
system, you must monitor as follows:
(A) You must monitor for the
unregulated contaminants on List 1 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, 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 small systems.
(B) You must monitor for the
unregulated contaminants on List 2 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, if you
are notified by your State or EPA that
you are part of the Screening Surveys.
(C) You must monitor for the
unregulated contaminants on List 3 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, if you
are notified by your State or EPA that
you are part of the Pre-Screen Testing.
(v) Small systems purchasing their
entire water supply from another
-------
Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations 50613
system. If you own or operate a public
water system (other than a transient
system) that serves 10,000 or fewer
persons and purchase your entire water
supply from a wholesale public water
system, you must monitor as follows:
(A) You must monitor for the
unregulated contaminants on List 1 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, that
have a "sampling location" indicated as
"distribution system" if you are notified
by your State or EPA that you are part
of the State Monitoring Plan for small
systems.
(B) You must monitor for the
unregulated contaminants on List 2 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, that
have a "sampling location" indicated as
"distribution system" if you are notified
by your State or EPA that you are part
of the Screening Surveys.
(C) You must monitor for the
unregulated contaminants on List 3 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, that
have a "sampling location" indicated as
"distribution system" if you are notified
by your State or EPA that you are part
of the Pre-Screen Testing.
(2) How would I be selected for the
monitoring under the State Monitoring
Plan, the Screening Surveys, or the Pre-
Screen Testing? (i) State Monitoring
Plan. Only a representative sample of
small systems must monitor for
unregulated contaminants. EPA will
select a national representative sample
of small public water systems in each
State through the use of a random
number generator. Selection will be
weighted by population served within
each system water source type (surface
or ground water) and system size
category (systems serving 25-500, 501-
3,300, and 3,301-10,000 persons). EPA
may allocate additional systems to water
source types or system size categories to
increase the statistical inferential ability
for those categories. EPA will also select
a small group of systems to be "Index
systems." Systems selected as Index
systems are required to provide
information about their site and
operation that will serve to allow
extrapolation of their results to other
systems of similar size, rather than
collecting detailed information at every
small system. Each State will have the
opportunity to make some modifications
to the list of small systems that EPA
selects. You will be notified by the State
or EPA if your system is part of the final
State Monitoring Plan.
(ii) Screening Surveys. The purpose of
the Screening Surveys is to determine
the occurrence of contaminants in
drinking water or sources of drinking
water for which analytical methods
have recently been developed for
unregulated contaminant monitoring.
EPA will select up to 300 systems to
participate in each survey by using a
random number generator. You will be
notified by the State or EPA if your
system is selected for monitoring under
the Screening Surveys.
(iii) Pre-screen Testing. The purpose
of Pre-Screen Testing is to determine the
occurrence of contaminants for which
EPA needs to evaluate new analytical
methods in locations where the
contaminants are most likely to be
found. EPA will select up to 200
systems to participate in this testing
after considering the characteristics of
the contaminants, precipitation, system'
operation, and environmental
conditions. You will be notified by the
State or EPA that your system has been
selected for monitoring under the Pre-
Screen Testing program.
(3) For which contaminants must I
monitor? Lists 1, 2 and 3 of unregulated
contaminants are listed in the following
table:
TABLE 1.—UNREGULATED CONTAMINANT MONITORING REGULATION (1999) LIST
List 1—Assessment Monitoring Chemical Contaminants
1 -Contaminant
2,4-dinitrotoluene
2,6-dinitrotoluene
Acetochlor
DCPA mono-acid
degradate.
DCPA di-acid
degradate.
4,4'-DDE
EPTC
Molinate
MTBE
2-CAS registry num-
ber
121-14-2
606-20-2
34256-82 1
887-54-7
2136-79-0
72-55-9
2212-67-1
1634-04-4
3-Analytical methods
EPA 525.2"
EPA 525.2" . ..
Reserved m
EPA 515.1»
EPA 51 5.2"
D5317-93"
AOAC 992.32-=
EPA 51 5.1" ,
EPA 515.2"
D5317-93"
AOAC 992.32 =
EPA 508"
EPA 508.1 "
EPA 525.2"
D5812-96"
AOAC 990.06 =
EPA 507"
EPA 525.2"
D5475-93"
AOAC 991 .07=
EPA 507"
EPA 525.2"
D5475-93"
AOAC 991 .07=
EPA 524.2"
D5790-95"
SM 621 ODd
SM 6200B"
4-Minimum reporting
level
2 uq/L=
2 uo/L0
Reserved m
1 uq/L0
1 UQ/LC
0.8 u.q/Le
1 ua/Lo
0.9 uq/Lc
5 UQ/L&
5-Sampling location
EPTDS f
EPTDS f
EPTDS f
EPTDS f
EPTDS f
EPTDS f
EPTDS f
EPTDS f
EPTDS f
6-Period during which
monitoring to be com-
pleted
2001—2003
2001—2003
2001—2003
2001-2003
2001-2003
2001 2003
2001 2003
2001-2003
2001-2003
-------
!, inil1" Hi,, IE, i|i|i mi1" NIIII,,"''!!!' ',"
1 I1 lij,' .
50614 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
r
*,'!
V i" ; i,"i'
i, „"; J ,
;,if :l." '
TABLE 1.—UNREGULATED CONTAMINANT MONITORING REGULATION (1999) LIST—Continued
List 1—Assessment Monitoring Chemical Contaminants
' " ' ' • "r ; „•!'
1 •Contaminant
I '" '. "\ -"I;,;:, ,':.,f, ,j
''"Nitrobenzene '...«
Perchtorate
Torbacil
2-CAS registry num-
ber
98-95-3
14797-73-0
5902-51-2
3-Analytical methods
EPA 524.2 a
D5790-95"
SM6210D«"
SM6200Bd
Reserved m
EPA 507 »
EPA 525.2«
D5475-93»
AOAC991.07"
4-Minimum reporting
level
10 nq/Ls
Reserved m
2 uq/Lc
5-Sampling location
EPTDSf
EPTDS f
EPTDSf .
6-Period during which
monitoring to be com-
pleted
2001-2003
2001—2003
2001—2003
List 2—Screening Survey Chemical Contaminants
To Be Sampled After Notice of Analytical Methods Availability
1 -Contaminant
i ,2-df pheoylhydrazine
t-rnotnyl-prisnol
4-dlchlbfbphehol
2,4-dinitrophenol
2|4,6-trichlor6phenol ...
^achtorESA
Dtalnon
Disulfoton
Diuron ,..
Fonofos
LJnuron ,.
Potbniurn-210
Profusion
Terbufos
RDX
2-CAS registry num-
ber
122-6&-7
95-48-7
120-83-2
51-28-5
88-06-2
TBD»>
333-41-5
298-04-4
330-54--I
944-22-9
330-55-2
13981-52-7
1610-18-0
13071-79-9
121-82-4
3-Analytical methods
EPA 525.2*
SPE/GC/MS1
SPE/GC/MS1 . ...
SPE/GC/MS1
SPE/GC/MS i
TBD1"
EPA 525 2 k
EPA 525.2''
SPE/HPLC/ UVi
EPA 525.2'
SPE/HPLC/UVJ
Reserved11
EPA 525.2''
EPA 525.2 k
Reserved11
4-Minimum reporting
level
Reserved11
Reserved11
Reserved h
Reserved11 .
Reserved11
Reserved*1
Reserved11
Reserved11
Reserved h
Reserved11
Reserved11
Reserved11
Reserved11
Reserved11
Reserved11
5-Sampling location
EPTDSf
EPTDSf
EPTDS f
EPTDS*
EPTDSf- .
EPTDSf
EPTDS f
EPTDSf
EPTDS f
EPTDSf .-
EPTDS f
Reserved*
EPTDSf
EPTDSf
EPTDSf
6-Period during which
monitoring to be com-
pleted
Reserved h
Reserved ^
Reserved h
Reserved ^
Reserved h
Reserved h
Reserved h
Reserved ^
Reserved h
Reserved h
Reserved h
Reserved h
Reserved h
Reserved h
Reserved
List 2^7Screening Survey Microbiological Contaminants
To Be Sampled After Notice of Analytical Methods Availability
1-Contam!nant
lil1:"':,,! „ <
A®romorias
2-ldentification num-
ber
Reserved11
3-Analytical methods
Reserved11
4-Minimum reporting
level
Reserved11
5-Sampling location
Reserved*
6-Period during which
monitoring to be com-
pleted
Reserved
f:f' i !",„' !!i
List S^Pre-Screen Testing Radionuclides
To Be Sampled After Notice of Analytical Methods Availability
1 -Contaminant
Lead-210
2-CAS registry num-
ber
14255-04-0
3-Analytical methods
Reserved11
4-Minimum reporting
level
Reserved11
5-Sampling location
Reserved11
6-Period during which
monitoring to be com-
pleted
Reserved
-------
Federal Register/Vol. 64. No. 180/Friday, September 17, 1999/Rules and Regulations 50615
List 3—Pre-Screen Testing Microorganisms
To Be Sampled After Notice of Analytical Methods Availability
1 -Contaminant
Cyanobacteria (blue-
green algae, other
freshwater algae
and their toxins).
Echoviruses
Coxsackieviruses
Helicobacter pylori
Microsporidia
Calciviruses
Adenoviruses
2-ldentification num-
ber
Reserved*
Reserved*
Reserved*
Reserved*
Reserved*
Reserved*
Reserved*
3-Analytical methods
Reserved*
Reserved*
Reserved*
Reserved*
Reserved*
Reserved*
Reserved*
4-Minimum reporting
level
Reserved*
Reserved*
Reserved* . .
Reserved *
Reserved *
Reserved *
Reserved*
5-Sampling location
Reserved *
Reserved *
Reserved *
Reserved *
Reserved *
Reserved *
Reserved*
6-Period during which
monitoring to be com-
pleted
Reserved h
Reserved h
Column headings are:
1-Chemical or microbiological contaminant: the name of the contaminants to be analyzed.
2-CAS (Chemical Abstract Service Number) Registry No. 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 or density of the contaminant must be meas-
ured using the Approved Analytical Methods.
5-Sampling Location: the locations within a PWS at which samples must be collected.
6-Years During Which Monitoring to Be Completed: The years during which the sampling and testing are to occur for the indicated contami-
nant.
The procedures shall be done in accordance with the documents listed below. The incorporation by reference of the following documents listed
in footnotes b-d was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the doc-
uments may be obtained from the sources listed below. Information regarding obtaining these documents can be obtained from the Safe Drinking
Water Hotline at 800-426-4791. Documents may be inspected at EPA's Drinking Water Docket, 401 M Street, SW., Washington, DC 20460
(Telephone: 202-260-3027); or at the Office of Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC.
"The version of the EPA methods which you must follow for this Rule are listed at 40 CFR 141.24 (e).
b Annual Book of ASTM Standards, 1996 and 1998, Vol. 11.02, American Society for Testing and Materials. Method D5812-96 is located in
the Annual Book of ASTM Standards, 1998, Vol. 11.02. Methods D5790-95, D5475-93, and D5317-93 are located in the Annual Book of ASTM
Standards, 1996 and 1998, Vol 11.02. Copies may be obtained from the American Society for Testing and Materials, 100 Barr Harbor Drive,
West Cqnshohocken, PA 19428.
b Official Methods of Analysis of AOAC (Association of Official Analytical Chemist) International, Sixteenth Edition, 4th Revision, 1998, Volume
I, AOAC International, First Union National Bank Lockbox, PO Box 75198, Baltimore, MD 21275-5198.1-800-379-2622.
dSM 6210 D is only found in the 18th and 19th editions of Standard Methods for the Examination of Water and Wastewater, 1992 and 1995,
American Public Health Association; either edition may be used. SM 6200 B is only found in the 20th edition of Standard Methods for the Exam-
ination of Water and Wastewater, 1998. Copies may be obtained from the American Public Health Association, 1015 Fifteenth Street NW, Wash-
ington, DC 20005.
<= Minimum Reporting Level determined by multiplying by 10 the least sensitive method's minimum detection limit (MDL=standard deviation
times the Student's T value for 99% confidence level with n-1 degrees of freedom), or when available, multiplying by 5 the least sensitive meth-
od's estimated detection limit (where the EDL equals the concentration of compound yielding approximately a 5 to 1 signal to noise ratio or the
calculated MDL, whichever is greater).
fEntry Points to the Distribution System (EPTDS), After Treatment, representing each non-emergency water source in routine use over the
twelve-month period of monitoring; sampling must occur at the EPTDS, unless the State has specified other sampling points that are used for
compliance monitoring 40 CFR 141.24 (f)(1), (2), and (3). See 40 CFR 141.40(a)(5)(ii)(C) for a complete explanation of requirements, including
the use of source (raw) water sampling points.
s Minimum Reporting Levels (MRL) for Volatile Organic Compounds (VOC) determined by multiplying either the published Method Detection
Limit (MDL) or 0.5 ug/L times 10, whichever is greater. The MDL of 0.5 p.g/L (0.0005 mg/L) was selected to conform to VOC MDL requirements
of 40 CFR 141.24(f)(17)(i)(E).
*To be Determined at a later time
1 Compound currently not listed as a contaminant in this method.
j Methods development currently in progress to develop a solid phase extraction/high performance liquid chromatography/ultraviolet method for
the determination of this compound.
k Compound listed as being a contaminant using EPA Method 525.2; however, adequate sample preservation is not available. Preservation
studies currently being conducted to develop adequate sample preservation.
1 Methods development currently in progress to develop a solid phase extraction/gas chromatography/mass spectrometry method for the deter-
mination of this compound.
m If not determined by regulation by December 31, 2000, this contaminant will become part of List 2.
(4) What general requirements must I
follow for monitoring List 1
contaminants? (i) All systems. You
must:
(A) Collect samples of the listed
contaminants in accordance with
paragraph (a) (5) of this section and
Appendix A of this section and any
other specific instructions provided to
you by the State or EPA,
(B) Analyze the additional parameters
specified below in Table 2. "Water
Quality Parameters to be Monitored
with UCMR Contaminants" for each
relevant contaminant type. You must
analyze the parameters for each
sampling event of each sampling point,
using the method indicated, and report
using the data elements 1 through 10 in
Table 1, § 141.35(d), Unregulated
Contaminant Monitoring Reporting
Requirements;
(C) Review the laboratory testing
results to ensure reliability; and
(D) Report the results as specified in
§141.35.
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50616 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
TABLE 2.—WATE? QUALITY PARAMETERS To BE MONITORED WITH UCMR CONTAMINANTS
' 41 ,i I,,'!': • , " ! "|M . . '' • V ''" ' ' • '" '"i' '"'" 'III I' '!' ' , I I" ; '
PsiBITlGtSf
pH „..
Turbidity
Temperature
Free Disinfectant Residual
Total Disinfectant Residual
111 1 ,L U
li, "' 'llf ' "i.ii , 1 illilli
Chemical;
Microbiological
Microbiological
Microbiological
Microbiological
Microbiological
EPA method
2 150 1
2 150 2
4,5-) 80 1
Methodology
Standard methods 1
4500-H + B
2130 B*
2550
4500-CI D
4500-CI F
4500-CI G
4500-CI H
4500-ClO2 D
4500-CIO2 E
4500-O3 B
4500-CI D
4500-CI E*
4500-CI F
4500-CI G"
4500-CI I
Other
AQTM ni9Q^— R4.3
ASTM D1 293-95 3
f^l 1 MothnH 946
AQTM n -i pgQ— QR 3
ASTM D 1253— 86 3
The procedures shall be done in accordance with the documents listed below. The incorporation by reference of the following documents was
approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the documents may be ob-
tained Irpjn the sources listed below. Information regarding obtaining these documents can be obtained from the Safe Drinking Water Hotline at
800-426^4791, Dpcurngnjs may be inspected at EPA's Drinking Water Docket, 401 M Street, SW., Washington, DC 20460 (Telephone: 202-
260-3027); or at the Office of Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC.
1The 18th and 19th Editions of Standard Methods for the Examination of Water and Wastewater, 1992 and 1995. Methods 2130 B; 2550-
4500-CI D, E, F, G, H, I; 4500-CIO2 D, E; 4500-H + B; and 4500-O3 B in the 20th edition Standard Methods for the Examination of Water and
Wastewater, 1998, American Public Health Association, 1015 Fifteenth St. NW, Washington D.C., 20005.
2 Methods 150.1 and 150.2 ire available from US EPA, NERL, 26 W. Martin Luther King Dr., Cincinnati, Ohio 45268. The identical methods
are also in "Methods for Chemical Analysis of Water and Wastes," EPA-600/4-79-020, March 1983, available from the National Technical Infor-
mation Service (NTIS), U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, Virginia 22161, PB84-128677. (Note: NTIS toll-free
Bomber is 800-553-6847.)
*Anmj$i Book of ASTM Standards, Editions 1994 and 1996,Volumes 11.01, American Society for Testing and Materials, 100 Barr Harbor
Drive, West Conshohocken, PA 19428. Version D1293-84 is located in the Annual Book of ASTM Standards, 1994, Volumes 11.01. Version
D1293-95 is located in the AnnualBook_of ASTM Standards, 1996, Volumes 11.01.
4 "Technical Notes on Drinking Water," EPA-600/R-94-173, October 1994, Available at NTIS, PB95-104766.
8 "Methods for the Determination of Inorganic Substances in Environmental Samples," EPA-600/R-93-100, August 1993. Available at NTIS,
PB94-121811
«GU Method 2, 'Turbidity," November 2,1992, Great Lakes Instruments Inc., 8855 North 55th St., Milwaukee, Wisconsin 53223.
(H) Large systems. In addition to
paragraph (a) (4) (i) of this section, you
"8 ! i "iftist arrange for testing of the samples
jfccording to the methods specified for
each contaminant in Table 1,
Unregulated Contaminant Monitoring
Regulation (1999) List, in paragraph
(a) (3) of this section, and in Appendix
A of this section.
(Ui) Small systems. Unless directed
.Otherwisej>y the State or EPA, in
addition to paragraph (a)(4)(i) of this
section 'you must:
»• (A) Properly receive, store, maintain
a|id use the sampling equipment sent to
you from the laboratory designated by
(B) Sample at the times specified by
$e State or the EPA;
(C) Collect and pack samples in
accordance with the instructions sent to
you by the laboratory designated by
,=: 'I,,!'1, EPA: and
(D) Send the samples to the laboratory
designated by EPA.
(5) What specific sampling and
quality control requirements must I
follow for monitoring of List 1
contaminants? (i) All systems. Unless
the State or EPA informs you of other
sampling arrangements, you must
comply with the following
requirements:
(A) 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
since some samples must be processed
at the laboratory within 30 hours of
collection. You must not collect samples
on Friday, Saturday or Sunday because
sampling on these days would not allow
samples to be shipped and received at
the laboratory within 30 hours.
(B) No compositing of samples. You
must not composite (that is, combine,
mix or blend) the samples. You must
collect, preserve and test each sample
separately.
(C) Review and reporting of results.
After you have received the laboratory
results, you must review and confirm
the system information and data
regarding sample collection and test
results. You must report the results as
provided in §141.35.
(ii) Large systems. In addition to
paragraph (a) (5) (i) of this section, you
must comply with the following:
(A) Timeframe. You must collect the
samples in one twelve-month period
during the years indicated in column 6
of Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List.
(B) Frequency. You must collect the
samples within the timeframe and
according to the following frequency
specified by contaminant type and
water source type:
'I1
i" a,'i
ii , a
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Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations 50617
TABLE 3.—MONITORING FREQUENCY BY CONTAMINANT AND WATER SOURCE TYPES
Contaminant type .
Chemical
Microbiological
Water source type
Surface water
Ground water
Surface and ground water
Timeframe
Twelve (12) months
Twelve (12) months
Twelve (12) months
Frequency
Four Quarterly samples taken as follows* Select either
the first, second, or third month of a quarter and
sample in that same month of each of four (4) con-
secutive quarters a to ensure that one of those sam-
pling events occurs during the vulnerable time.b
Two (2) times in a year taken as follows* Sample dur-
ing one (1) month of the vulnerable time" and dur-
ing one (1) month five (5) to seven (7) months ear-
lier or later.0
Two (2) times in a year taken as follows* Sample dur-
ing one (1) month of the vulnerable timeb and dur-
ing one (1) month five (5) to seven (7) months ear-
lier or later.0
a "Select either the first, second, or third month of a quarter and sample in that same month of each of four (4) consecutive quarters" means
that you must monitor during each of the four (4) months of either: January, April, July, October; or February, May, August, November; or March,
June, September, December.
b "Vulnerable time" means May 1 through July 31, unless the State or EPA informs you that it has selected a different time period for sampling
as your system's vulnerable time.
c "Sample during one (1) month of the vulnerable time and during one (1) month five (5) to seven (7) months earlier or later" means, for exam-
ple, that if you select May as your 'Vulnerable time" month to sample, then one (1) month five (5) to seven (7) months earlier would be either
October, November or December of the preceding year, and one (1) month five (5) to seven (7) months later would be either, October, Novem-
ber, or December of the same year.
(C) Location. You must collect
samples at the location specified for
each listed contaminant in column 5 of
the Table 1, UCMR (1999) List, in
paragraph (a) (3) of this section. The
sampling location for chemical
contaminants must be the entry point to
the distribution system or the
compliance monitoring point specified
by the State or EPA under 40 CFR
141.24(fJ(l), (2), and (3). If the
compliance monitoring point as
specified by the State is for source (raw)
water and any of the contaminants in
paragraph (a) (3) of this section are
detected, then you must also sample at
the entry point to the distribution
system at the frequency indicated in
paragraph (a)(5)(ii)(B) of this section
with the following exception: If the
State or EPA determines that sampling
at the entry point to the distribution
system is unnecessary because no
treatment was instituted between the
source water and the distribution
system that would affect measurement
of the contaminants listed in paragraph
(a) (3) of this section, then you do not
have to sample at the entry point to the
distribution system.
(D) Sampling instructions. You must
follow the sampling procedure for the
method specified in column 3 of List 1
of Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, for each
contaminant.
(E) Testing and analytical methods.
For each listed contaminant, you must
use the analytical method specified in
column 3 of List 1 of Table 1,
Unregulated Contaminant Monitoring
Regulation (1999) List, in paragraph
(a) (3) of this section, the minimum
reporting levels in column 4 of List 1 of
Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, and the
quality control procedures specified in
Appendix A of this section.
(F) Sampling deviations. If you do not
collect a sample according to the
procedures specified for a listed
contaminant, you must resample within
14 days of observing the occurrence of
the error (which may include
notification from the laboratory that you
must resample) following the
procedures specified for the method.
(This resampling is not for confirmation
sampling but to correct the sampling
error.)
(G) Testing. You must arrange for the
testing of the contaminants by a
laboratory certified under § 141.28 for
compliance analysis using the EPA
analytical methods listed in column 3
for each contaminant in Table 1,
Unregulated Contaminant Monitoring
Regulation (1999) List, in paragraph
(a) (3) of this section, whether you use
the EPA analytical methods or non-EPA
methods listed in Table 1.
(iii) Small systems that are part of the
State Monitoring Plan. Unless directed
otherwise by the State or EPA, in
addition to paragraph (a) (5) (i) of this
section, you must comply with the
following:
(A) Timeframe and frequency. You
must collect samples at the times
specified for you by the State or EPA,
within the timeframe specified in
paragraph (a) (5) (ii) (A) of this section
and according to the frequency specified
in paragraph (a) (5) (ii)(B) of this section
for the contaminant type and water
source type.
(B) Location. You must collect
samples at the locations specified for
you by the State or EPA.
(C) Sampling deviations. If you do not
collect a sample according to the
instructions provided to you for a listed
contaminant, then you must report the
deviation on the sample reporting form
that you send to the laboratory with the
samples. You must resample following
instructions that you will be sent from
EPA's designated laboratory or the State.
(D) Sample kits. You must store and
maintain the sample collection kits sent
to you by EPA's designated laboratory in
a secure place until used for sampling.
You should read the instructions for
each kit when you receive it. If
indicated in the kit's instructions, you
must freeze the cold packs. 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 or
arrive damaged, you must notify EPA's
designated laboratory which sent you
the sample collection kits.
(E) 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 preparing
the sample and shipping containers for
-------
50618 Federal Register/Vol. 64, No. ISO/Friday, September 17, 1999/Rules and Regulations
shipment. You must also comply with
the instructions sent to you by EPA's
designated laboratory concerning the
handling of sample containers for
specific contaminants.
(F| Duplicate samples. EPA will select
syste'mS In the State Monitoring Plan
that milst collect duplicate samples for
quality control. If your system is
Selected, you will receive two sample
kits that you must use. You must use the
Same sampling protocols for both sets of
Camples, following the instructions in
the duplicate sample kit.
(G) Sampling forms. You must
completely fill out the sampling forms
sent to you by the laboratory, including
|he data ejemente 1 through 6 listed in
§ l4i.35(d) for each sample. You must
sign and date the sampling forms.
(H) Sample submission. Once you
have, cqUected the samples and
completely filled in the sampling forms,
you must send the samples and the
sampling forms to the laboratory
designated in your instructions.
(6) What additional requirements
must I follow if my system is selected as
an Index system? If your system is
selected as an Index system in the State
Monitoring Plan, you must assist the
State or EPA in identifying appropriate
sampling locations and provide
information on which wejls and intakes
are in use at the, time of sampling, well
casing and screen depths (if known) for
jthose vigils, and the pumping rate of
each well or intake at the time of
sampl
tat must I do if my system is
Fre-Screen Testing? (i) Large systems. If
your syslem serves over 10,000 persons,
you must collect and arrange for testing
of the contaminants in List 2 and List 3
Qf Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, in
accordance with the requirements set
out in paragraphs (a) (4) and (5) of this
section. You must send the samples to
one of die laboratories designated by
EPA in your notification. You must
report the test results to EPA, and
provide a copy to the State, as specified
in 40 CFR 141.35.
(ii) Small systems. If your system
serves 10,000 or fewer persons, you
must collect samples in accordance with
the instr^ctlpns gent tp you by the State
or EPA. or. if informed by the State or
EPA that the State or EPA will collect
tlie sample, you must assist the State or
EPA in identifying the appropriate
sampling locations and in taking the
samples. EPA will report the test results
to you and the State.
(8) What is a violation of this Rule? (i)
Any failure to monitor in accordance
with § 141.40(a) (3) through (7) and
Appendix A is a monitoring violation.
(ii) Any failure to report in accordance
with § 141.35 is a reporting violation.
(b) Requirements for State and Tribal
Participation. (1) How can I, as the
director of a State or Tribal drinking
water program, participate in
unregulated contaminant monitoring,
including Assessment Monitoring
(which includes the State Monitoring
Plan for small systems), the Screening
Surveys, and Pre-Screen Testing of all
systems? You can enter into a
Memorandum of Agreement (MO A)
with the EPA that describes your State's
or Tribe's activities to:
(i) Accept or modify the initial plan.
EPA will first specify the systems
serving 10,000 or fewer persons by
water source and size in an initial State
Monitoring Plan for each State using a
random number generator. EPA will
also generate a replacement list of
systems for systems that may not have
been correcdy specified on the initial
plan. This initial State Monitoring Plan
will also indicate the year and day, plus
or minus two (2) weeks from the day,
that each system must monitor for the
contaminants in List 1 of Table 1 of this
section, Unregulated Contaminant
Monitoring Regulation (1999) List. EPA
will provide you with the initial
monitoring plan for your State or Tribe,
including systems to be Index systems
and those systems to be part of the
Screening Surveys. Within sixty (60)
days of receiving your State's initial
plan, you may notify EPA that you
either accept it as your State Monitoring
Plan or request to modify the initial
plan by removing systems that have
closed, merged or are purchasing water
from another system and replacing them
with other systems. Any purchased
water system associated with a non-
purchased water system must be added
to the State Monitoring Plan if the State
determines that its distribution line is
the location of the maximum residence
time or lowest disinfectant residual of
the combined distribution system. In
this case, the purchased water system
must monitor for the contaminants for
which the "distribution system" is
identified as the point of "maximum
residence time" or "lowest disinfectant
residual," depending on the
contaminant, and not the community
water system selling water to it. You
must replace any systems you removed
from the initial plan with systems from
the replacement list in the order they
are listed. Your request to modify the
initial plan must include the modified
plan and the reasons for the removal
and replacement of systems. If you
believe that there are reasons other than
those previously listed for removing and
replacing one or more other systems
from the initial plan, you may include
those systems and their replacement
systems in your request to modify the
initial plan. EPA will review your
request to modify your State's initial
plan. Please note that information about
the actual or potential occurrence or
non-occurrence of contaminants at a
system or a system's vulnerability to
contamination is not a basis for removal
from or addition to the plan.
(ii) Determine an alternate vulnerable
time. Within 60 days of receiving the
initial State Monitoring Plan, you may
also determine that the most vulnerable
time of the year for any or all of the
systems in the plan, and for any of the
large systems that must monitor, is some
period other than May 1 through July
31. If you make this determination, you
must modify the initial plan to indicate
the alternate vulnerable time and to
which systems the alternate vulnerable
time applies. EPA will review these
determinations when you submit your
request to modify your State's initial
monitoring plan to the EPA. You must
notify the small system(s) in your final
State Monitoring Plan and the large
system(s) of the most vulnerable time(s)
of the year that you have specified for
them to sample for one of their sampling
events. You must notify them at least 90
days before their first unregulated
contaminant sampling is to occur. You
may need to consider the timing of
monitoring in paragraph (b)(l)(iii) of
this section.
(iii) Modify the timing of monitoring.
Widiin sixty (60) days of receiving the
initial plan, you may also modify the
plan by selecting an alternative year and
day, plus or minus two (2) weeks,
within the years specified in column 6,
List 1 of Table 1, Unregulated
Contaminant Monitoring Regulation
(1999) List, in paragraph (a) (3) of this
section, for monitoring for each system
in the initial plan as long as
approximately one-third of the systems
in the State Plan monitor in each of the
three (3) years listed. This monitoring
may be coordinated with regulated
contaminant compliance monitoring at
your discretion. You must send the
modified plan to EPA.
(iv) Identify alternate sampling points
for small systems in the State
Monitoring Plan. All systems are
required to monitor for the
contaminants at the sampling locations
specified in column 5, List 1 of Table 1,
Unregulated Contaminant Monitoring
Regulation (1999) List, in paragraph
(a) (3) of this section, unless the State
specifies an alternate compliance
sampling point as the sampling location.
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Federal Register/Vol. 64, No. 180/Friday, September 17, 1999/Rules and Regulations 50B19
If the compliance sampling points for
the small systems in the State
Monitoring Plan are different than those
specified in paragraph (a) (3) of this
section, then you must indicate these
sampling points in the plan. These
alternative sampling points must allow
proper sampling and testing for the
unregulated contaminants.
(v) Notify small and large systems of
their monitoring responsibilities. You
must provide notification to systems in
the plan and, where appropriate, the
large systems, at least ninety (90) days
before sampling must occur.
(vi) Provide instructions to systems
that are part of the final State
Monitoring Plan. You must send a
monitoring schedule to each system
listed in the State Monitoring Plan and
instructions on location, frequency,
timing of sampling, use of sampling
equipment, and handling and shipment
of samples based on these regulations.
EPA will provide you with guidance for
these instructions. If you perform the
sampling or make alternative
arrangements for the sampling at the
systems in the plan, you must inform
EPA at least six (6) months before the
first monitoring is to occur and address
the alternative monitoring arrangements
in the MOA.
(vii) Participate in monitoring for the
Screening Surveys for small and large
systems. Within 120 days prior to
sampling, EPA will notify you which
systems have been selected to
participate in the Screening Surveys, the
sampling dates, the designated
laboratory for testing, and instructions
for sampling. You must review the small
systems that EPA selected for the State
Monitoring Plan to ensure that the
systems are not closed, merged or
purchasing water from another system
(unless the system is to conduct
microbiological contaminant
monitoring), and then make any
replacements in the plan, as described
in paragraph (b) (1) (i) of this section.
You must notify the selected systems in
your State of these Screening Surveys
requirements. You must provide the
necessary Screening Surveys
information to the selected systems at
least ninety (90) days prior to the
sampling date.
(viii) Participate in monitoring for
Pre-Screen Testing for small and large
systems. You can participate in Pre-
Screen Testing in two ways.
(A) First, within ninety (90) days of
EPA's letter to you concerning initiation
of Pre-Screen Testing for specific
contaminants, you can identify from
five (5) up to twenty-five (25) systems in
your State that you determine to be
representative of the most vulnerable
systems to these contaminants, modify
your State Monitoring Plan to include
these most vulnerable systems if any
serve 10,000 or fewer persons, and
notify EPA of the addition of these
systems to the State Plan. These systems
must be selected from all community
and non-transient noncommunity water
systems. EPA will use the State-
identified vulnerable systems to select
up to 200 systems nationally to be
monitored considering the
characteristics of the contaminants,
precipitation, system operation, and
environmental conditions.
(B) Second, within 120 days prior to
sampling, EPA will notify you which
systems have been selected, sampling
dates, the designated laboratory for
testing of samples for systems serving
10,000 or fewer persons and approved
laboratories for systems serving more
than 10,000 persons, and instructions
for sampling. You must notify the
owners or operators of the selected
systems in your State of these Pre-
Screen Testing requirements. At least
ninety (90) days prior to the sampling
date, you must provide the necessary
Pre-Screen Testing information to the
owners or operators of the selected
systems and then inform EPA that you
took this action to allow sufficient time
for EPA to ensure laboratory readiness.
(ix) Revise system's treatment plant
location(s) to include latitude and
longitude. For reporting to the Safe
Drinking Water Information System,
EPA already requires reporting of either
the latitude and longitude or the street
address for the treatment plant location.
If the State enters into an MOA, the
State must report each system's
treatment plant location(s) as latitude
and longitude (in addition to street
address, if previously reported) by the
time of the system's reporting of
Assessment Monitoring results to the
National Drinking Water Contaminant
Occurrence Database.
(2) What if I decide not to participate
in an MOA? If you decide not to enter
into an MOA with EPA to develop the
State Monitoring Plan for small systems,
the initial monitoring plan that EPA
sent you will become the final State
Monitoring Plan for your State or Tribe.
In that case, you may still notify each
public water system of its selection for
the plan and instructions for monitoring
as long as you notify EPA that you will
be undertaking this responsibility at
least six (6) months prior to the first
unregulated contaminant monitoring.
(3) Can I add contaminants to the
Unregulated Contaminant Monitoring
List? Yes, the SDWA allows Governors
of seven (7) or more States to petition
the EPA Administrator to add one or
more contaminants to the Unregulated
Contaminant Monitoring Regulation
(1999) List, in paragraph (a) (3) of this
section. The petition must clearly
identify the reason(s) for adding the
contaminants) to the monitoring list in
paragraph (a) (3) of this section,
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 Unregulated
Contaminant Monitoring Regulation
(1999) List, in paragraph (a) (3) of this
section.
(4) Can I waive monitoring
requirements? Only with EPA approval
and under very limited conditions.
Conditions and procedures for obtaining
the only type of waiver available under
these regulations are as follows:
(i) Application. You may apply to
EPA for a State-wide waiver from the
unregulated contaminant monitoring
requirements for public water systems
serving more than 10,000 persons. To
apply for such a waiver, you must
submit an application to EPA that
includes the following information:
(A) the list of contaminants on the
Unregulated Contaminant Monitoring
List for which you request a waiver, and
(B) documentation for each
contaminant in your request
demonstrating that the contaminants
have not been used, applied, stored,
disposed of, released, naturally present
or detected in the source waters or
distribution systems in your State
during the past 15 years, and that it does
not occur naturally in your State.
(ii) Approval. EPA will notify you if
EPA agrees to waive monitoring
requirements.
Appendix A to § 141.40—Quality Control
Requirements for Testing All Samples
Collected
Your system must ensure that the quality
control requirements listed below for testing
of samples collected and submitted under
§ 141.40 are followed:
(1) Sample Collection/Preservation. Follow
the sample collection and preservation
requirements for the specified method for
each of the contaminants in Table 1, UCMR
(1999) List, 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
the laboratory must follow.
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50620 Federal Register/Vol. 64. No. 180/Friday, September 17, 1999 / Rules and Regulations
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(2) Method Detection Limit. Calculate the
laboratory method detection limit (MDLs) for
each contaminant in Table 1, Unregulated
Contaminant Monitoring Regulation (1999)
List, of paragraph (a) (3) of this section using
the appropriate specified method according
to procedures in 40 CFR Part 136, Appendix
B with the exception that the contaminant
concentration us.ed to fortify reagent water
must be less than or equal to the minimum
reporting level (MRL) for the contaminants as
specified in column 4, Table 1, UCMR (1999)
List, in paragraph (a) (3) of this section. The
p"":";,, ^palculated MDLjs equal to the standard
deviation times the Student's T value for
I,,, ; ,$9% confidence level with, n-1 degrees of
freedom. (The MDL must be less than or
1,, ..'I'equal to one-half of the 'MRL.)
(3) Calibration. Follow the initial
calibration requirements as specified in the
method utilized. Calibration must be verified
initially with a low-level standard at a
, concentjatipn at or below the MRL for each
'contaminant. Perform a continuing
.' •(' calibration ver^cation'fo|lqw|ng every 10th
sample. The calibration verification must be
performed by alternating low-level and mid-
level calibration standards. The low-level
standard Is defined as a concentration at or
|l b^elow the MRL with an'apce'ptance range"of
±40%. The mid-level standard is in the
i, ,": middle of the calibration range with an
acceptance 'range' of;±20%.
(4) Reagent Blank Analysis. Analyze one
laboratory reagent (method) blank per sample
" let/batch,,that is tteated.exactly as a sample.
„ ' ;„ jhe maximum,,,,allowable,,background
i" •*": epricentfStion is, one-half=of the MRL for all
contaminants. A field reagent blank is
jrequired only for EPA Method 524.2 (or
equivalent listed methods, D5790.95,
SM6210D, and SM6200B).
(5) Quality Control Sample. Obtain a
quality control sample from an external
source to check laboratory performance at
least once each quarter.
(6) Matrix Spike and Duplicate. Prepare
and analyze the sample matrix spike (SMS)
for accuracy and matrix spike duplicate
(MSD) samples for precision to determine
method accuracy and precision for all
contaminants in Table 1, Unregulated
Contaminant Monitoring Regulation (1999)
List, in paragraph (a) (3) of this section. SMS/
MSD samples must be prepared and analyzed
at a frequency of 5% (or one SMS/MSD set
'"""iif'jpc'r e'very' 20 samples) or with each sample
batch whichever is more frequent. In
''!'. "laditipn, the,,SMS/TvCp_spike concentrations
j ' w!',must ^.alternated" between, a low-level spike
',_ " iBfid'VnicMevel spike approximately 50% of
ine timef (For example: a set of 40 samples
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will require preparation and analysis of two
SMS/MSD sets. The first set must be spiked
at either the low-level or mid level, and the
second set must be spiked with the other
standard, either the low-level or mid-level,
whichever was not used for the initial SMS/
MSD set). The low-level SMS/MSD spike
concentration must be within ±20% of the
MRL for each contaminant. The mid-level
SMS/MSD spike concentration must be
within ±20% of the mid-level calibration
standard for each contaminant, and should
represent, where possible, an approximate
average concentration observed in previous
analyses of that analyte. The spiking
concentrations must be reported in the same
units of measure as the analytical results.
(7) Internal Standard Calibration. As
appropriate to a method's requirements to be
used, test and obtain an internal standard for
the methods for each chemical contaminant
in Table 1, Unregulated Contaminant
Monitoring Regulation (1999) List, in
paragraph (a) (3) of this section, a pure.
contaminant of known concentration, for
calibration and quantitation purposes. The
methods specify the percent recovery or
response that you must obtain for acceptance.
(8) Method Performance Test. As
appropriate to a method's requirements, test
for surrogate compounds, a pure contaminant
unlikely to be found in any sample, to be
used to monitor method performance. The
methods specify the percent recovery that
you must obtain for acceptance.
(9) Detection Confirmation. Confirm any
chemical contaminant detected above the
MRL by gas chromatographic/mass
spectrometric (GC/MS) methods. If testing
resulted in first analyzing the sample extracts
via specified gas chromatographic methods,
an initial confirmation by a second column
dissimilar to the primary column may be
performed. If the contaminant detection is
confirmed by the secondary column, then the
contaminant must be reconfirmed by GC/MS
using three (3) specified ion peaks for
contaminant identification. Use one of the
following confirming techniques: perform
single point calibration of the GC/MS system
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 GC/MS
system regardless of whether that verification
standard concentration is within ± 50% of
sample response. If GC/MS analysis confirms
the initial contaminant detection, report
results determined from the initial analysis.
(10) Reporting. Report the analytical results
and other data, with the required data listed
in 40 CFR 141.35, Table 1. Report this data
electronically to EPA, unless EPA specifies
otherwise, and provide a copy to the State.
Systems must coordinate with their
laboratories for electronic reporting to EPA to
ensure proper formatting and timely data
submission.
PART 142— NATIONAL PRIMARY
DRINKING WATER REGULATIONS
IMPLEMENTATION
1. The authority citation for part 142
continues to read as follows:
Authority: 42 U.S.C. 300f, 300g-l, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, SOOj-4,
300j-9, and300j-ll.
§142.15 [Amended]
2. Section 142.15 is amended by
removing and reserving paragraph (c)(3).
3. Section 142.16 is amended by
revising paragraphs (e) introductory
text, (e)(l) introductory text, and
(e) (1) (i) (C) to read as follows:
§ 1 42.1 6 Special primacy requirements.
*****
(e) An application for approval of a
State program revision which adopts the
requirements specified in §§ 1 4 1 . 1 1 ,
141.23, 141.24, 141.32, 141.61 and
141.62 must contain the following (in
addition to the general primacy
requirements enumerated elsewhere in
this part, including the requirement that
State regulations be at least as stringent
as the federal requirements) :
(1) If a State chooses to issue waivers
from the monitoring requirements in
§§ 141.23 and 141.24, the State shall
describe the procedures and criteria
which it will use to review waiver
applications and issue waiver
determinations.
(i) * * *
(C) The State decision criteria,
including the factors that will be
considered in deciding to grant or deny
waivers. The decision criteria must
include the factors specified in
§§ 141.24(f)(8) and 141.24(h)(6).
*****
[FRDoc. 99-23030 Filed 9-3-99; 12:35 pm]
BILLING CODE 6560-5D-P
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