[Federal Register Volume 65, Number 42 (Thursday, March 2, 2000)]
[Rules and Regulations]
[Pages 11373-11385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4761]
[[Page 11371]]
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Part II
Environmental Protection Agency
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40 CFR Part 141
Unregulated Contaminant Monitoring Regulation for Public Water Systems:
Analytical Methods for Perchlorate and Acetochlor; Announcement of
Laboratory Approval and Performance Testing (PT) Program for the
Analysis of Perchlorate; Final Rule and Proposed Rul
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e
Federal Register/Vol. 42 , No. 65 /Thursday, March 2, 2000/Rules and
Regulations
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 141
[FRL-6544-6 ]
Unregulated Contaminant Monitoring Regulation for Public Water
Systems; Analytical Methods for Perchlorate and Acetochlor;
Announcement of Laboratory Approval and Performance Testing (PT)
Program for the Analysis of Perchlorate
AGENCY: Environmental Protection Agency.
ACTION: Direct final rule.
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SUMMARY: The Safe Drinking Water Act (SDWA), as amended in 1996,
requires the U.S. Environmental Protection Agency to establish criteria
for a program to monitor unregulated contaminants and to publish a list
of contaminants to be monitored. In fulfillment of this requirement,
EPA published the Revisions to the Unregulated Contaminant Monitoring
Rule (UCMR) on September 17, 1999 (64 FR 50556), which included a list
of contaminants to be monitored.
Both perchlorate and acetochlor were placed on the UCMR (1999) List
1, Assessment Monitoring, with the method listed as ``Reserved''
pending imminent conclusion of EPA refinement and review of the
analytical methods for perchlorate and acetochlor. EPA is taking direct
final action on this rule. This rule specifies the approved analytical
methods for measurement of perchlorate and acetochlor in drinking water
and includes notice to all laboratories interested in supporting
perchlorate monitoring of the laboratory approval requirements,
including participation in a perchlorate Performance Testing (PT)
Program. The rule also includes minor technical changes to correct or
clarify the rule published on September 17, 1999.
DATES: This rule is effective on January 1, 2001, without further
notice, unless EPA receives adverse comment by April 3, 2000. If EPA
receives such comment we will publish a timely withdrawal in the
Federal Register and inform the public that the rule will not take
effect.
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.
For judicial review purposes, this final rule is promulgated as of
1:00 p.m. (Eastern time) on March 16, 2000, as provided in 40 CFR 23.7.
Any laboratory interested in conducting perchlorate monitoring must
participate in the Performance Testing (PT) Program and should submit a
request letter to EPA, received at the EPA by March 31, 2000. EPA will
not be able to consider any letters received after this date. Any
interested laboratory which does not meet this deadline or fails to
successfully pass the initial PT study and would still like to support
this monitoring, will need to submit a request letter by October 6,
2000 in order to be eligible for a second PT study.
ADDRESSES: Send written comments to the Comment Clerk, docket number W-
99-19, Water Docket (MC 4101), U.S. EPA, 401 M Street, SW, Washington
DC, 20460. Please submit an original and three copies of your comments
and enclosures (including references). The full record for this
document has been established under docket number W-99-19 and includes
supporting documentation as well as printed, paper versions of
electronic comments. The full record is 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 (Docket No. W-99-19) 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. Laboratories interested in supporting
perchlorate monitoring must send a request letter to: Daniel P.
Hautman, Perchlorate PT Program Coordinator, MLK 140, U.S. EPA, 26 W.
Martin Luther King Dr., Cincinnati, OH 45268.
FOR FURTHER INFORMATION CONTACT: Rachel Sakata, Standards and Risk
Management Division, U.S. Environmental Protection Agency, 401 M Street
(MC 4607), Washington DC 20460, (202) 260-2527. For technical
information regarding the methods, contact David Munch, Technical
Support Center, U.S. Environmental Protection Agency, 26 W. Martin
Luther King Dr., Cincinnati OH, 45268, (513) 569-7843.
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: For copies of EPA Method 314.0,
``Determination of Perchlorate in Drinking Water Using Ion
Chromatography,'' contact the EPA Safe Drinking Water Hotline within
the United States at (800) 426-4791 (Hours are Monday through Friday,
excluding federal holidays, from 9:00 a.m. to 5:30 p.m. Eastern Time).
Alternately, the method can be assessed and downloaded directly on-line
at www.epa.gov/safewater/methods/sourcalt.html.
Abbreviations and Acronyms Used in the Preamble and Final Rule
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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.
ASTM...................................... American Society for Testing
and Materials.
CAS....................................... Chemical Abstract Service.
CASRN..................................... Chemical Abstract Service
Registry Number.
CCL....................................... Contaminant Candidate List.
CFR....................................... Code of Federal Regulations.
CWS....................................... community water system.
DCPA...................................... dimethyl
tetrachloroterephthalate,
chemical name of the
herbicide dacthal.
DCPA mono- and di-acid degradates......... degradation products of
DCPA.
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.
FSIS...................................... federalism summary impact
statement.
IC........................................ ion chromatography.
ICR....................................... Information Collection Rule.
MCL....................................... maximum contaminant level.
MCT....................................... Matrix Conductivity
Threshold.
MDL....................................... method detection limit.
MRL....................................... minimum reporting level.
MS........................................ sample matrix spike.
MSD....................................... sample matrix spike
duplicate.
NCOD...................................... National Drinking Water
Contaminant Occurrence
Database.
NTNCWS.................................... non-transient non-community
water system.
NTTAA..................................... National Technology Transfer
and Advancement Act.
OGWDW..................................... Office of Ground Water and
Drinking Water.
[[Page 11373]]
OMB....................................... Office of Management and
Budget.
PBMS...................................... Performance-based
Measurement System.
PWS....................................... Public Water System.
QA........................................ quality assurance.
QC........................................ quality control.
RFA....................................... Regulatory Flexibility Act.
SBREFA.................................... Small Business Regulatory
Enforcement Fairness Act.
SDWA...................................... Safe Drinking Water Act.
SM........................................ Standard Methods.
SOP....................................... standard operating
procedure.
TDS....................................... total dissolved solid.
UCMR...................................... Unregulated Contaminant
Monitoring Regulation/Rule.
UCM....................................... Unregulated Contaminant
Monitoring.
UMRA...................................... Unfunded Mandates Reform Act
of 1995.
USEPA..................................... United States Environmental
Protection Agency.
VOC....................................... volatile organic compound.
ug/L...................................... micrograms per liter.
uS/cm..................................... microsiemens per centimeter.
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Preamble Outline
I. Regulatory Background
II. Explanation of Today's Action
A. Relation to the UCMR Published in September 1999
B. Systems Affected by This Rule
C. Analytical Methods
1. Perchlorate
2. Acetochlor
3. Quality Control and Analytical Confirmation
D. Peer Review
1. Perchlorate
2. Acetochlor
E. Laboratory Approval and Certification
1. Perchlorate
2. Acetochlor
F. Implementation
G. Performance-based Measurement System
III. Technical Changes and Clarification to Sec. 141.40
A. Change to Sec. 141.40 (a)(5)(ii)(C)
B. Change to Sec. 141.40 (a)(5)(ii)(G)
C. Change to Sec. 141.40 (a)(5)(iii)(G)
D. Change to Sec. 141.40 (b)(1)(i)
E. Change to Sec. 141.40 (b)(1)(vii)
F. Clarification of Monitoring for DCPA Mono and Di-Acid
Degradate
IV. Cost and Benefits of the Rule
V. 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 (RFA), as amended by the Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5
U.S.C. 601 et.seq.
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. Executive Order 13132--Federalism
I. Executive Order 13084--Consultation and Coordination with
Indian Tribal Governments
J. Administrative Procedure Act
K. Congressional Review Act
VI. Public Involvement in Regulation Development
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 under the revised UCMR. A
community water system (CWS) is a public water system which serves at
least 15 service connections used by year-round residents or regularly
serve 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 are required to monitor for perchlorate and
acetochlor. Transient non-community systems, which are systems that do
not regularly serve at least 25 of the same persons over six months per
year, are not 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:
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Category Examples of potentially regulated entities SIC
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State, Territorial, and Tribal governments........................... States, territorial and tribal governments that analyze water 9511
samples on behalf of public water systems required to conduct such
analysis; States, Territorial and tribal governments that
themselves operate community and non-transient non-community water
systems required to monitor.
Industry............................................................. Private operators of community and non-transient non-community water 4941
systems required to monitor.
Municipalities....................................................... Municipal operators of community and non-transient non-community 9511
water systems required to monitor.
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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. To determine
whether your facility is regulated by this action, you should carefully
examine the applicability criteria in Sec. 141.40 of the revised
Unregulated Contaminant Monitoring Rule, published September 17, 1999
in 64 FR 50556. If you have questions regarding the applicability of
this action to a particular entity, consult the first person listed in
the preceding FOR FURTHER INFORMATION CONTACT section.
I. Regulatory Background
SDWA section 1445 (a)(2), as amended in 1996, requires EPA to
establish criteria for a program to monitor unregulated contaminants
and to publish a list of contaminants to be monitored. To meet these
requirements, EPA published the Revisions to the Unregulated
Contaminant Monitoring Regulation (UCMR) for Public Water Systems on
September 17, 1999, (64 FR 50556) which substantially revised the
previous Unregulated Contaminant Monitoring (UCM) Program, codified at
40 CFR 141.40. The UCMR revised the regulations at 40 CFR 141.35,
141.40, 142.16 and deleted and reserved 142.15(c)(3). The UCMR covered:
(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, referred to as the UCMR
(1999) List; (3) procedures for selecting and monitoring a nationally
representative sample of small PWSs (those serving
[[Page 11374]]
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. This final rule
included a list of contaminants which must be monitored beginning
January 2001 to obtain data on contaminants occurring or likely to
occur in the drinking water of public water systems.
Perchlorate and acetochlor were included on the UCMR (1999) List 1,
with their analytical methods listed as ``reserved'', pending the
imminent conclusion of EPA refinement and review of the analytical
methods and implementation of a laboratory approval for perchlorate and
validation studies for acetochlor. Today's rule amends the 1999 UCMR to
specify methods for monitoring of perchlorate and acetochlor. Today's
rule also contains several technical corrections to the September 1999
rule.
II. Explanation of Today's Action
Today's action promulgates analytical methods for measurement of
perchlorate and acetochlor in drinking water, contaminants which were
placed on the UCMR (1999) List 1.
A. Relation to the UCMR Published in September 1999
The final UCMR, published on September 17, 1999, consisted of many
program elements designed to enhance and improve the unregulated
contaminant monitoring program in several important ways. The rule
specifies (1) which systems must monitor, including a statistical
approach to select a representative sample of small public water
systems; (2) a list of contaminants for which systems must monitor; (3)
the monitoring time, frequency, and location of sampling; (4) methods
to be used for analyzing the contaminants; (5) reporting requirements;
and (6) State and Tribal participation concerning the implementation of
the monitoring program.
EPA divided the list of contaminants for which systems must monitor
into three separate lists based on the availability of analytical
methods. List 1, Assessment Monitoring, consisted of 12 contaminants
for which analytical methods were available at the time the rule was
promulgated, with the exception of perchlorate and acetochlor. List 2,
Screening Survey, consisted of 16 contaminants for which analytical
methods are expected to be developed by the time of initial monitoring
in 2001. List 3, Pre-Screen Testing, consisted of 8 contaminants for
which analytical methods research is being conducted. Only the
contaminants on List 1 must be monitored 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. EPA believed that this three-
tiered approach to the UCMR, which was recommended by stakeholders,
reflected 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.
Although methods were not available at the time of publication,
perchlorate and acetochlor were both included on List 1, Assessment
Monitoring, because EPA was engaged in the final validation of their
analytical methods. EPA felt that, with the validation, the analytical
methods would be sufficiently ready for monitoring by 2001. Therefore,
these contaminants were added to List 1, Assessment Monitoring. Today's
rule publishes the analytical methods, minimum reporting levels, and
sampling locations for perchlorate and acetochlor. This rule will
enable monitoring of these contaminants to begin with all the other
List 1, Assessment Monitoring contaminants in 2001.
As required in the September 1999 UCMR, surface water systems will
monitor for perchlorate and acetochlor quarterly for one year and
ground water systems will monitor twice in one year. Assessment
Monitoring must be done within the three years of 2001 to 2003, which
will allow coordination with the three-year compliance monitoring cycle
for regulated contaminants. One of these quarterly or semiannual
sampling events must occur in the most vulnerable period of May through
July, or an alternate vulnerable period designated by the State, to
ensure monitoring of elevated contaminant concentrations.
B. Systems Affected by This Rule
The UCMR states that monitoring in the rule focuses on the
occurrence or likely occurrence of contaminants in drinking water of
community and non-transient, non-community water systems. For
regulatory purposes, public water systems are categorized as
``community water systems'' or ``non-community water systems''.
Community water systems 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 non-transient non-
community water systems and transient non-community water systems. Non-
transient non-community systems are those that regularly serve at least
25 of the same persons over 6 months per year (e.g., schools,
industrial buildings). Transient systems are all other non-community
systems, which typically serve a transient population such as
restaurants or hotels. In the September 1999 UCMR, EPA excluded
transient water systems from this monitoring. 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. The results
from the very small community and non-transient non-community systems
can be extrapolated to the transient non-community systems.
With respect to size, about 2,800 large systems (defined here as
those serving more than 10,000 persons) provide drinking water to about
80 percent of the US population served by public water systems. The
SDWA does not provide for EPA funding of this monitoring. Under the
UCMR program all large systems will be required to monitor for
unregulated contaminants. Only a representative sample of systems
serving 10,000 persons or fewer will be required to monitor for
unregulated contaminants. SDWA requires EPA to pay for the reasonable
testing costs for the representative sample of small systems.
C. Analytical Methods
1. Perchlorate. In today's rule, EPA is amending the September 1999
UCMR to include EPA Method 314.0 ``Determination of Perchlorate in
Drinking Water Using Ion Chromatography, Revision 1 (November 1999)''
for the analysis of perchlorate. In this method, perchlorate is
separated and measured, using a system comprised of an ion
chromatographic pump, sample injection valve, guard column, analytical
column, suppressor device, and conductivity detector. This method
recommends an ion chromatography (IC) column and analytical conditions
which were determined to be the most effective for the widest array of
sample matrices.
The development of Method 314.0 included investigations into the
performance of alternate 4 millimeter IC guard and analytical separator
columns which are specified for the IC analysis of perchlorate
specified by the California Department of Health Services and also by
Dionex
[[Page 11375]]
Corporation. These alternate guard /separator columns included the
Dionex AG5/AS5 and the Dionex AG11/AS11, respectively. The AG5/AS5 is
currently specified in the standard operating procedure (SOP) for the
IC analysis of perchlorate written by the State of California,
Department of Health Services. The AG5/AS5 is a hydrophilic analytical
column which was developed several years ago for higher valence anions
such as tripolyphosphate and trimetaphosphate as well as polarizable
anions such as iodide, thiocyanate and thiosulfate. The AG11/AS11 is
used by several commercial laboratories conducting IC analysis for
perchlorate and is recognized by California as an acceptable alternate
to the AG5/AS5. A multi-laboratory validation study included both of
these analytical columns and indicated comparable results could be
attained. In the Agency's studies, both the AG5/AS5 and the AG11/AS11
performed well for reagent water and simulated drinking water samples
with low to moderate common anion levels, such as sulfate, chloride and
carbonate, but as these levels increased, performance began to diminish
for both columns. The more recently developed AG16/AS16 columns could
tolerate much higher levels of these anions and are therefore
recommended in Method 314.0 as the columns of choice although alternate
columns such as the AS5 and AS11 are permitted to be used.
The Agency's primary reason for publishing Method 314.0 instead of
simply approving the published SOPs was the impact of high
concentrations of total dissolved solids (TDS); primarily sulfate,
carbonate, and chloride on the accuracy of perchlorate determinations.
Neither the California Department of Health Services nor the Dionex
Corporation method incorporate a quality control element to assess the
impact of high concentrations of TDS. Sample matrices with high
concentrations of common anions such as chloride, sulfate and carbonate
can make the analysis problematic by destabilizing the baseline in the
retention time window for perchlorate. This is evidenced by observing a
protracted tailing following the initial elution of the more weakly
retained anions which extends into the perchlorate retention time
window. These common anion levels can be indirectly assessed by
monitoring the conductivity of the matrix. Consequently, Method 314.0
specifies that all sample matrices must be monitored for conductivity
prior to analysis. When the laboratory determined Matrix Conductivity
Threshold (MCT) is exceeded, procedures incorporating sample dilution
and/or pretreatment must be performed.
The columns and conditions identified in Method 314.0 are
recommended since they bear the highest tolerance for the very highest
levels of common inorganic anions interference; however, use of the
columns and conditions recommended in other ion chromatographic methods
for the analyses of perchlorate are also permitted as long as they meet
the performance criteria specified in Method 314.0.
In addition to recommending the AG16/AS16 column used in Method
314.0, the primary advantages of Method 314.0 are the requirements
associated with determining the matrix conductivity threshold (MCT) and
reducing the impact of TDS on the accuracy of perchlorate
determinations. The MCT is the highest permitted conductance of an
unknown sample matrix, measured prior to conducting the analysis, which
is used to determine when sample matrix dilution or pretreatment is
required. The conductance of a sample matrix is proportional to the
common anions present in the matrix (which contribute to the TDS level)
which can greatly affect the integrity of this analysis. The MCT is
dependent upon the chromatographic column used, its age and condition,
the instruments used, and the analyst. Consequently, this threshold is
not method defined and must be determined by the individual analytical
laboratory during the initial demonstration of capability and confirmed
in each analysis batch using an instrument performance check solution.
At EPA's laboratory the MCTs determined varied from approximately 3000
microsiemens per centimeter (uS/cm) for the AS5 and AS11 columns to
approximately 6000 uS/cm for the AS16 column. Instructions on how to
determine a laboratory's MCT are included in EPA Method 314.
Both pretreatment cartridges and, in some cases, sample dilution
can be effective as a means to eliminate or minimize the impact of
certain matrix interferences. With any proposed pretreatment, Method
314.0 specifies that the analyst must verify that the target analyte is
not affected by monitoring recovery after pretreatment and that no
background contaminants are introduced by the pretreatment. Use of
advanced analytical separator column technology which employs higher
capacity anion exchange resins, such as the AG16/AS16 which is
recommended in Method 314.0, greatly reduces the need for these
cartridges.
2. Acetochlor. Several commenters on the proposed UCMR revisions
asserted that acetochlor could be reliably measured using EPA Method
525.2. At the time that EPA issued the final UCMR, EPA did not have
available the laboratory data necessary to support those assertions. In
addition, no data were available concerning the sample and extract
storage stability of acetochlor when stored under the preservation
conditions specified in EPA Method 525.2. Since that time, EPA has
obtained those data necessary to support approval of EPA Method 525.2
for the analysis of acetochlor. Today's rule, therefore, amends the
September 1999 UCMR to specify this method for acetochlor analysis.
3. Quality Control and Analytical Confirmation. Additional guidance
for quality control and analytical confirmation are specified in a
supplement to the ``Supplement to UCMR Analytical Methods and Quality
Control Manual'', available by the time this rule is published.
D. Peer Review
EPA conducted two separate peer reviews, one for the perchlorate
method and the other to determine if acetochlor could be added to EPA
Method 525.2. The results of the peer review are summarized here:
1. Perchlorate. The peer review for EPA Method 314.0 was conducted
in early November 1999 by three experts, external to the EPA and
familiar with perchlorate issues, occurrence, and monitoring. All three
peer reviewers concluded the method was ``acceptable after minor
revision''. The majority of comments were editorial, requiring either
typographical editing or further text clarification and explanation.
All reviewers provided either verbal or written support for including
the MCT as a quality control parameter used to monitor matrix
conductance as it relates to reducing interference problems associated
with high TDS levels.
2. Acetochlor. In November 1999, EPA provided peer reviewers with a
memorandum titled ``Documentation of Agency Decisions Concerning the
Analyses of Acetochlor in the Unregulated Contaminant Monitoring
Regulation''. This memorandum detailed the minimum detection level,
precision and accuracy, analyte stability, and current health effects
information that was used in the decision to approve EPA Method 525.2
for the analysis of acetochlor in the UCMR, and to set the Minimum
Reporting Level (MRL) at 2 ug/L. This
[[Page 11376]]
memorandum was reviewed by three methods experts external to the
Agency, with one reviewer representing a State and the other two
reviewers representing drinking water utilities. All three were
supportive of the Agency's decision to approve EPA Method 525.2 for the
analysis of acetochlor, and with the decision to set the MRL at 2 ug/L.
Reports of these peer reviews and our responses to their comments
are in the docket referred to above under ADDRESSES.
E. Laboratory Approval and Certification
1. Perchlorate. In order to allow data on perchlorate occurrence in
PWSs that were obtained prior to January 2001 to be grandparented, the
data must meet the reporting requirements of the UCMR which include the
successful completion of the perchlorate PT Program by a laboratory
approved to perform the original analyses. Approximately 2,800 large
PWSs that serve more than 10,000 persons will be required to monitor
for perchlorate using an approved laboratory. For the small PWSs
serving 10,000 or fewer persons, EPA will contract with an approved
laboratory for perchlorate laboratory analysis.
Since this rule specifies the approved analytical method for
analyses of perchlorate and is a new method which includes matrix
specific quality control criteria, laboratories must go through a
separate approval process to test for perchlorate. Laboratories
certified under 40 CFR 141.28 for compliance analysis using the EPA
analytical methods specified in the UCMR (1999) List, whether the
laboratory uses EPA or non-EPA analytical methods on the List, are
automatically certified to do analyses of UCMR List 1 contaminants
using the listed methods for which it is certified, with the exception
of perchlorate.
Those laboratories interested in performing perchlorate testing
must be previously certified (by the primacy agency in the State where
the laboratory is located) to conduct laboratory analysis supporting
regulatory compliance monitoring of drinking water for any inorganic
anion using an approved ion chromatographic method (such as nitrate
analysis by EPA Method 300.0). In addition, the laboratory must
successfully complete the perchlorate Performance Testing (PT) Program.
This PT Program involves a blind control study, using a test sample
with an unknown value.
Any laboratory, wishing to participate in the perchlorate PT
Program and obtain approval, must submit a letter requesting this
information to EPA, received no later than March 31, 2000. Any
interested laboratory which does not meet this deadline or fails to
successfully pass this initial PT study and still wishes to support
this monitoring, will need to submit a request letter by October 6,
2000 in order to be eligible for a second PT study. EPA will not be
able to consider any laboratory request letters received after October
6, 2000 and does not intend to conduct any additional PT studies. Any
laboratory gaining approval in the first PT study will not be required
to participate in the second PT study. These will be the only two PT
studies offered for laboratories wishing to gain approval to conduct
perchlorate analysis in support of UCMR assessment monitoring. Any
laboratory which does not request participation by October 6, 2000 and
fails to pass either of these two PT studies will not be approved to
support this perchlorate monitoring. The submitted request letter must
be signed by the laboratory manager with a statement that the
laboratory is currently certified, by the primacy agency in which the
laboratory is located, to perform drinking water compliance monitoring
using an approved ion chromatographic method. A copy of the letter or
certificate issued by the State or primacy agency detailing this
certification must also be submitted. Details pertaining to laboratory
certification can be found on-line at www.epa.gov/OGWDW/labcint.html.
A laboratory's request letter must include the following
information:
(1) Laboratory Name.
(2) Complete Laboratory Mailing Address.
(3) Ion chromatography analytical method the laboratory is
certified to perform.
(4) A copy of the letter or certificate issued by the State or
primacy agency which issued the certification to the laboratory.
(5) Contact Person.
(6) Contact Phone, FAX, and e-mail (if available).
The letter should be mailed to: Perchlorate PT Program Coordinator,
U.S.EPA, MLK 140, 26 W. Martin Luther King Dr., Cincinnati, Ohio
45268.
To participate successfully in this program the laboratory will
also need to become proficient in the application of U.S. EPA Method
314.0, ``Determination of Perchlorate in Drinking Water Using Ion
Chromatography''. Laboratories must follow the procedure as well as all
the QC protocols prescribed in the method. To obtain a copy of EPA
Method 314.0, contact the Safe Drinking Water Hotline at 1-800-426-4791
or access an electronic copy of the method directly on-line at
www.epa.gov/safewater/methods/sourcalt.html.
Upon successful completion of the perchlorate PT Program, EPA will
provide each successful laboratory with an approval letter identifying
the laboratory by name and the approval date. This letter may then be
presented to any Public Water System (PWS) as evidence of laboratory
approval for perchlorate analysis supporting the UCMR. Laboratory
approval is retained as long as the laboratory maintains certification
by the State or primacy agency in which the laboratory is located, to
perform drinking water compliance monitoring using an approved ion
chromatographic method. If a laboratory maintains this certification,
the laboratory approval for perchlorate analysis supporting the UCMR
will be limited to the time period beginning on the date specified in
the EPA issued approval letter and extending through January 28, 2004.
Additionally, EPA will establish a website indicating which
laboratories are approved to conduct perchlorate monitoring.
2. Acetochlor. No performance testing sample analyses are required
for laboratory approval for the analysis of acetochlor under the UCMR.
All laboratories currently certified to perform drinking water
compliance monitoring using EPA Method 525.2 are automatically approved
to perform acetochlor analysis in the UCMR.
F. Implementation
Implementation of this rule will allow monitoring for perchlorate
and acetochlor using the specified methods in this rule. Systems will
follow the monitoring requirements described in the September 1999 UCMR
at the designated sampling location four times a year for surface water
systems, or two times six months apart for ground water systems, with
one of the sampling times during the May-July vulnerable time, or an
alternate vulnerable period specified by the State.
G. 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
[[Page 11377]]
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 a National Primary Drinking Water Regulation, 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.
III. Technical Changes and Clarification to Sec. 141.40
After reviewing the UCMR subsequent to its publication in the
Federal Register on September 17, 1999, EPA found five changes that
should be made to correct or clarify the wording of the regulation.
These changes are at Sec. 141.40 (a)(5)(ii)(C), (a)(5)(iii)(G),
(b)(1)(i), and (b)(1)(vii) and described here.
A. Change to Sec. 141.40 (a)(5)(ii)(C)
This paragraph describes the location at which unregulated
contaminant monitoring is to occur. However, the paragraph provides an
exception where a State determines that no treatment is instituted
between the source water and the distribution system that would affect
measurement of the contaminants listed in Sec. 141.40 (a)(3). EPA is
correcting this provision to delete redundant wording that does not
help to clarify the exception.
B. Change to Sec. 141.40 (a)(5)(ii)(G)
This paragraph describes the requirements for testing of the
contaminants listed in Sec. 141.40 (a)(3) by a certified laboratory.
This paragraph states that laboratories certified to conduct compliance
analysis using EPA analytical methods in column 3, Sec. 141.40 (a)(3),
may conduct analyses for the UCMR contaminants. EPA is adding a
paragraph to address laboratory approval to analyze for perchlorate in
drinking water samples.
C. Change to Sec. 141.40 (a)(5)(iii)(G)
This paragraph specifies that sampling forms must be completed by
owners or operators of small systems conducting the sampling for
unregulated contaminants before sending the results to the EPA
designated laboratory. The data elements that the owner or operator
must complete are incorrectly specified as 1 through 6. The rule
corrects the language to identify the data elements to be 1 through 4:
Public Water System Identification Number; Public Water System Facility
Identification Number--Source, Treatment Plant, and Sampling Point;
Sample Collection Date; and Sample Identification Number.
The rule also corrects the reporting for small systems to include
data elements 5 through 10 if water quality parameters are required to
be reported from the field. These parameters include: Contaminant/
Parameter; Analytical Results-sign; Analytical Results-Value;
Analytical Result-Unit of Measure; Analytical Method Number; and Sample
Analysis Type. This clarification makes this section consistent with
Sec. 141.40 (a)(4)(i)(B) which applies to all systems analyzing for
water quality parameters.
D. Change to Sec. 141.40 (b)(1)(i)
This paragraph describes the process for States and Tribes to
accept or modify the State Monitoring Plans for small systems. The
paragraph incorrectly refers to ``distribution line.'' This reference
should be to a ``distribution system'' to be consistent with other
sections of and the intent of the rule.
E. Change to Sec. 141.40 (b)(1)(vii)
This paragraph describes the process for a State or Tribe to
participate in monitoring for the Screening Surveys for small and large
systems. This paragraph contains an exclusion for systems purchasing
water (unless the system is to conduct microbiological contaminant
monitoring)[emphasis added]. The intent of the exception identified in
the parenthetical phrase ``unless the system is to conduct
microbiological monitoring'' was to address any contaminants for which
the distribution system should be the appropriate location for
monitoring, not just microbiological contaminants. The reference to
microbiological contaminant monitoring is an artifact of a previous
draft of the rule which was not corrected. Today's rule provides the
intended wording and allows the exclusion of certain systems ``(unless
the system is to conduct monitoring for a contaminant with the sampling
location specified as the ``distribution system'').''
F. Clarification of Monitoring for DCPA Mono and Di-Acid Degradate
In the September 17, 1999, Federal Register (64 FR 50556), EPA
included as separate contaminants both DCPA mono-acid and DCPA di-acid
degradates on the UCMR (1999) Monitoring List. As noted in the ``UCMR
Analytical Methods and Quality Control Manual,'' August 1999, all of
the approved methods identify total mono and di-acid forms as a single
analytical result. None of the approved methods allow for the
identification and quantification of the individual acids. To provide
for the consistent reporting of results and to avoid confusion, EPA is
specifying in Table 1 of Sec. 141.40 (UCMR List 1, 1999) that the
single analytical result obtained from these methods should be reported
as total DCPA mono- and di-acid degradates.
IV. Cost and Benefits of the Rule
Today's amendment to the UCMR (64 FR 50555) adds methods for
monitoring perchlorate and acetochlor to the UCMR (1999) List 1. These
contaminants will be collected as part of the Assessment Monitoring
component of the UCMR program. Perchlorate and acetochlor were part of
the original UCMR (1999) List 1 contaminants, but were withheld from
the September 1999 Final Rule pending finalization of their analytical
methods. As described elsewhere in this Preamble, Assessment Monitoring
will be conducted over a 3-year period from 2001 to 2003 by all 2,774
large PWSs and a randomly selected representative sample of 800 small
systems.
Since perchlorate and acetochlor will be analyzed by laboratories
using water samples that are collected at the same time as the other 10
Assessment Monitoring contaminants, there are no additional labor costs
related to today's addition of these contaminants. Systems will only be
required to collect one additional sample for perchlorate analysis at
the same sampling point where they are collecting the other Assessment
Monitoring samples. No measurable added labor burden is associated with
filling one more sample bottle. Additional non-labor costs are solely
attributed to the laboratory fees/costs associated with analyzing
samples for these contaminants. These costs will only be incurred by
EPA and by large PWSs. No additional shipping costs will be incurred,
since the weight of one sample bottle will not increase the shipment
pricing category.
[[Page 11378]]
EPA assumes that no additional costs will be incurred for analysis
of acetochlor, since this contaminant will be analyzed under method
525.2, along with 2,4-dinitrotoluene and 2,6-dinitrotoluene. EPA
estimates that the average laboratory fee/cost for perchlorate
analysis, using the ion chromotography Method 314.0 will be $60 per
sample. The additional costs for laboratory analysis are calculated as
follows: the product of the number of systems and the number of entry
or sampling points is multiplied by the sampling frequency and then
multiplied by the cost of analysis.
The details of EPA's cost assumptions and estimates for Assessment
Monitoring contaminants, with the exception of perchlorate and
acetochlor, can be found in the Information Collection Request (ICR)
previously prepared for the UCMR (OMB number 2040-0208), which presents
estimated cost and burden for the 1999-2001 period. The Office of
Management and Budget (OMB) approved the ICR on June 30, 1999. An
inventory correction worksheet (ICW) was prepared for this rule to
address the hours and dollars associated with monitoring and analyzing
for perchlorate and acetochlor. Copies of the ICR 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: [email protected], or by calling: (202) 260-
2740. For technical information regarding the ICR, please contact Chuck
Job, U.S. Environmental Protection Agency, (4607); 401 M St., S.W.;
Washington DC 20460, by email at: [email protected], or by calling
(202) 260-7084. A copy may also be downloaded from the Internet at:
http:
//www.epa.gov/icr.
In preparing the UCMR ICR and the ICW, 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 below.
Over the UCMR implementation period of 2001 through 2005, EPA
estimates that the average annual cost of the nationwide addition of
perchlorate and acetochlor to Assessment Monitoring is approximately
$560,700, as follows:
1. EPA: $70,200, exclusively for the additional testing costs for
small systems.
2. States: $0.
3. Small systems: $0.
4. Large systems: $490,500.
The estimated average annual cost is approximately $177 per large
system.
V. 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
(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 13045, ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), applies
to any rule that (1) is determined to be ``economically significant''
as defined under Executive Order 12866 and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
This Rule is not subject to Executive Order 13045 because it is not
``economically significant'' as defined under Executive Order 12866.
Further, this rule is not subject to Executive Order 13045 because it
does not establish an environmental standard intended to mitigate
health or safety risks. This rule makes purely clarifying changes to
the September 1999 UCMR and establishes analytical test methods for
measurement of the unregulated contaminants perchlorate and acetochlor.
However, this Rule is part of the Agency's overall strategy for
deciding whether to regulate the contaminants under the Safe Drinking
Water Act (see discussion of the Contaminant Candidate List (CCL) at 63
FR 10273). Its purpose is to ensure that EPA obtains data on the
occurrence of contaminants on the CCL--specifically perchlorate and
acetochlor--where those data are currently 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 these contaminants.
C. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under 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
[[Page 11379]]
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 today's 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
(across the implementation period of 2001-2005), for State, local, and
tribal governments and the private sector, are estimated to be
$560,700, of which EPA will pay $70,200, or approximately 12 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. Small systems will incur minimal additional labor or
non-labor costs as a result of this rule, since laboratory analysis of
perchlorate and acetochlor will be conducted using samples that systems
were already collecting under the September 1999 UCMR. 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 et seq. and
has assigned OMB control number 2040-0208. As part of the September
1999 UCMR, the information to be collected under today's Rule fulfills
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
regulation accordingly. Reporting is mandatory. The data are not
subject to confidentiality protection.
For a discussion of the costs for the full monitoring program from
2001 through 2005, please refer to Section V., ``Costs and Benefits of
the Rule'' in the preamble. EPA has an approved ICR for the 10 UCMR
Assessment Monitoring contaminants and is in the process of processing
the ICW for the addition of perchlorate and acetochlor methods to the
UCMR. This discussion focuses on the estimated costs during the ICR
period of 1999-2001.
The cost estimates described below for the additional contaminants,
perchlorate and acetochlor, are solely attributed to additional
laboratory fees/costs. No additional labor or hour burden will be
incurred because of the addition of these contaminants to the UCMR
(1999) List 1. For Assessment Monitoring, the respondents are the 800
small water systems (in the national representative sample of systems
serving 10,000 or fewer people), the 2,774 large public water systems,
and the 56 States and primacy agents (3,630 total respondents). The
frequency of response varies across respondents and years. However,
there are no additional responses associated with this rule amendment,
and thus no additional hour burden for any respondents. Minimal
additional costs will be incurred by small systems or States. Large
systems and EPA will incur the additional laboratory fees/costs for the
analysis of perchlorate and acetochlor. For the three year ICR period
only, each large system respondent will incur an annual average
additional cost of $295. This was calculated by the average cost per
system over three years. [E.g., ($884 per large system) divided by
three years]. The additional cost for perchlorate and acetochlor is
estimated to be $300 per response by a large system. This is calculated
by the average cost per system over the three years [E.g., ($884 per
large system) divided by the average number of responses per system
over the entire three year period (2.9 per large system)].
EPA will incur no additional labor or hour costs for implementation
of today's rule. EPA's annual non-labor costs (for the ICR period 1999-
2001) are estimated to be $36,400 for the analysis of small system
perchlorate and acetochlor Assessment Monitoring samples. Non-labor
costs are solely attributed to the cost of sample testing for the 800
small systems.
Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and aintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.
E. Regulatory Flexibility Act (RFA), as amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et
seq.
The RFA generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations, and small
governmental jurisdictions.
The RFA provides default definitions for each type of small entity.
It also authorizes an agency to use alternative definitions for each
category of small entity, ``which are appropriate to the activities of
the agency'' after proposing the alternative definition(s) in the
Federal Register and taking comment. 5 U.S.C. 601(3)-(5). In addition
to the above, to establish an alternative small business definition,
agencies must consult with SBA's Chief Counsel for Advocacy.
For purposes of assessing the impacts of today's rule on all three
categories of small entities, EPA considered small entities to be
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. In accordance with the RFA
requirements, EPA proposed using this alternative definition for all
three categories of small entities in the Federal Register, (63 FR
7605, February 13, 1998) requested public comment, consulted with SBA
regarding the alternative definition as it relates to small
[[Page 11380]]
businesses, and finalized the alternative definition in the Consumer
Confidence Reports rulemaking, (63 FR 44511, August 19,1998). As stated
in that final rule, the alternative definition would be applied to this
regulation as well.
For the UCMR, published on September 17, 1999, EPA analyzed
separately the impact on small privately and publicly owned water
systems because of the different economic 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 1.
Table 1.--Number of Publicly and Privately Owned Systems To Participate in Assessment Monitoring
[Including perchlorate and acetochlor]
----------------------------------------------------------------------------------------------------------------
Publicly owned systems Privately owned
------------------------ systems
Size category ------------------------ Total--All
Non-index Index Non-index Index systems
systems systems systems systems
----------------------------------------------------------------------------------------------------------------
Ground Water Systems
----------------------------------------------------------------------------------------------------------------
500 and under....................................... 20 1 76 2 99
501 to 3,300........................................ 146 6 67 3 222
3,301 to 10,000..................................... 144 7 40 2 193
================================================================================================================
Subtotal ground................................. 310 14 183 7 514
----------------------------------------------------------------------------------------------------------------
Surface Water Systems
----------------------------------------------------------------------------------------------------------------
500 and under....................................... 18 0 49 0 67
----------------------------------------------------------------------------------------------------------------
501 to 3,300........................................ 51 2 23 1 77
3,301 to 10,000..................................... 106 5 30 1 142
Subtotal surface................................ 175 7 102 2 286
----------------------------------------------------------------------------------------------------------------
Total......................................... 485 21 285 9 800
----------------------------------------------------------------------------------------------------------------
The basis for the UCMR RFA certification for today's rule, which
adds perchlorate and acetochlor to the Assessment Monitoring program,
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 small
system costs for adding perchlorate and acetochlor to the Assessment
Monitoring program (2001-2005) will be approximately $350,890. Since
the Agency specifically structured the rule to avoid significantly
affecting small entities by assuming all costs for laboratory analyses,
shipping, and quality control for small entities, EPA incurs the
entirety of the costs associated with adding methods for monitoring
perchlorate and acetochlor to the Assessment Monitoring list. Table 2
presents the annual costs 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. The table also illustrates that no additional
costs are incurred by the small systems.
Table 2.--EPA Costs for Small Systems for the Addition of Perchlorate and Acetochlor Methods to UCMR Assessment
Monitoring
----------------------------------------------------------------------------------------------------------------
Cost description 2001 2002 2003 2004 2005 Total
----------------------------------------------------------------------------------------------------------------
Total Costs to EPA for Small System Sampling of Perchlorate and Acetochlor: analytical costs
----------------------------------------------------------------------------------------------------------------
$109,150 $109,150 $109,150 $11,720 $11,720 $350,890
----------------------------------------------------------------------------------------------------------------
Costs to Small Systems: no additional labor or non-labor costs incurred
----------------------------------------------------------------------------------------------------------------
$0 $0 $0 $0 $0 $0
----------------------------------------------------------------------------------------------------------------
Total Costs to EPA and Small Systems for UCMR
----------------------------------------------------------------------------------------------------------------
$109,150 $109,150 $109,150 $11,720 $11,720 $350,890
----------------------------------------------------------------------------------------------------------------
Number of Systems to be conducting Assessment Monitoring each Year (thus collecting perchlorate and acetochlor
samples): Non-Index and Index in 2001-2003, Index only in 2004-20051
----------------------------------------------------------------------------------------------------------------
Public............................ 182 182 182 107 21 533
----------------------------------------------------------------------------------------------------------------
Private........................... 104 104 104 81 9 267
Total......................... 286 286 286 188 30 800
----------------------------------------------------------------------------------------------------------------
1Total number of systems is 800. All 30 Index systems sample during each year 2001-005. 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 implementation cycle.
[[Page 11381]]
After considering the economic impacts of today's direct final rule
on small entities, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
EPA has determined that the addition of perchlorate and acetochlor to
the UCMR data collection will not affect small water utilities. The
rationale for this conclusion is that those 800 small PWSs that will
participate in Assessment Monitoring will not be required to conduct
additional activities related to this rule. Further, EPA will assume
all additional costs for testing of the samples for small systems. We
have therefore concluded that today's final rule will impose no
regulatory burden for small entities. Also, the minor amendments to the
UCMR are purely for clarification or correction, and do not impose any
costs.
F. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law No. 104-113, Section 12(d) (15 U.S.C.
272 note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
EPA searched for but did not find any voluntary consensus standards
for the measurement of acetochlor or perchlorate. Analytical methods
for perchlorate have been published by the California Department of
Health and by Dionex Corporation, however neither of these methods
incorporates a quality control element which assesses the impact of
high concentrations of total dissolved solids (TDS), frequently present
in water samples. The presence of these high TDS in samples can result
in inaccurate quantitation of perchlorate or may even mask its
presence. Therefore, EPA developed EPA Method 314.0 for the analysis of
perchlorate which incorporates a quality control element that both
identifies the presence of high concentrations of TDS and provides a
mechanism to reduce their concentrations, thereby permitting accurate
quantitation of perchlorate. In addition, EPA's Method 314.0 permits
the use of both the California Department of Health and the Dionex
procedures within its scope; therefore, laboratories currently using
either of these procedures can convert to using EPA Method 314.0 simply
by adopting the quality control element specified in EPA Method 314.0
without needing to change any other aspects of their analyses.
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, this regulation furthers the protection
of public health for all citizens, including minority and low-income
populations using public water supplies.
H. Executive Order 13132--Federalism
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999) requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
Under section 6 of Executive Order 13132, EPA may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or EPA
consults with State and local officials early in the process of
developing the proposed regulation. EPA also may not issue a regulation
that has federalism implications and that preempts State law unless the
Agency consults with State and local officials early in the process of
developing the proposed regulation.
This final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. This rule merely specifies the
analytical methods approved for the measurement of perchlorate and
acetochlor in drinking water, thereby allowing these contaminants to be
included in the UCMR Assessment Monitoring program and makes other
minor corrections to the September UCMR. Thus, the requirements of
section 6 of the Executive Order do not apply to this rule.
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 nor does it impose substantial
direct compliance costs on them. 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.
[[Page 11382]]
This rule will not impose substantial direct compliance costs on
such communities 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.
J. Administrative Procedure Act
EPA is publishing this methods rule without prior proposal because
it views this as a noncontroversial amendment and anticipates no
adverse comment. While developing these methods, EPA worked closely
with those people involved in similar work or developing similar
methods. For perchlorate, Method 314.0 is an adaptation of the current
methods available to test for perchlorate, but with additional QC
requirements. For the UCMR, public comment indicated that EPA Method
525.2 could perform analyses for acetochlor. However, elsewhere in this
issue of the Federal Register, EPA is publishing a separate document
that will serve as the proposal for the Unregulated Contaminant
Monitoring Regulation for Public Water Systems; Analytical Methods for
Perchlorate and Acetochlor if adverse comments are filed. This rule
will be effective on January 1, 2001, without further notice unless EPA
receives adverse comment by April 3, 2000. If EPA receives adverse
comment, we will publish a timely withdrawal in the Federal Register
informing the public that the rule will not take effect. EPA will
address all public comments in a subsequent final rule based on the
proposed rule. EPA will not institute a second comment period on this
action. Any parties interested in commenting must do so at this time.
Finally, the minor amendments made to the September 1999 UCMR in
today's rule are purely clarifying changes and thus public comment is
unnecessary under the Administrative Procedure Act. 5 U.S.C.
553(b)(3)(B).
K. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., 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.
VI. Public Involvement in Regulation Development
EPA's Office of Ground Water and Drinking Water has developed a
process for stakeholder involvement in its regulatory activities to
provide early input to regulation development. Today's rule amends the
September 1999 UCMR, by establishing the method requirements for
perchlorate and acetochlor. At the time of UCMR publication--September
1999--the methods for these contaminants were still under review by the
EPA. For a description of public involvement activities please see the
discussion at 64 FR 50556.
List of Subjects in 40 CFR Part 141
Environmental protection, Chemicals, Incorporation by reference,
Indian-lands, Intergovernmental relations, Reporting and recordkeeping
requirements, Water supply.
Dated: February 23, 2000.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, title 40, chapter I of
Code of Federal Regulations, are amended as follows.
PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS
1. The authority citation for part 141 continues to read as
follows:
Authority: 42 U.S.C. 300f, 300g-l, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.
2. Effective January 1, 2001 Sec. 141.40 as revised on 9/17/99 (64
FR 50556) and effective January 1, 2001 is further amended by:
a. Revising Table 1, List 1, in paragraph (a)(3) and revising the
column heading notations and footnotes at the end of paragraph (a)(3);
b. Revising paragraphs (a)(5)(ii)(C) and (a)(5)(ii)(G);
c. Revising paragraph (a)(5)(iii)(G);
d. Revising paragraph (b)(1)(i); and
e. Revising paragraph (b)(1)(vii).
The Revisions read as follows:
Sec. 141.40 Monitoring requirements for unregulated contaminants.
(a) * * *
(3) * * *
[[Page 11383]]
Table 1.--Unregulated Contaminant Monitoring Regulation (1999) List
[List 1--Assessment Monitoring Chemical Contaminants]
----------------------------------------------------------------------------------------------------------------
6--Period
during
2--CAS 3--Analytical 4--Minimum 5--Sampling which
1--Contaminant registry methods reporting location monitoring
number level to be
completed
----------------------------------------------------------------------------------------------------------------
2,4-dinitrotoluene..................... 121-14-2 EPA 525.2a 2 ug/Le EPTDSf 2001-2003
2,6-dinitrotoluene..................... 606-20-2 EPA 525.2a 2 ug/Le EPTDSf 2001-2003
Acetochlor............................. 34256-82-1 EPA 525.2a 2 ug/Lo EPTDSf 2001-2003
DCPA mono-acid degradaten.............. 887-54-7 EPA 515.1a 1 ug/Le EPTDSf 2001-2003
EPA 515.2a
D5317-93b
AOAC 992.32c
DCPA di-acid degradaten................ 2136-79-0 EPA 515.1a 1 ug/Le EPTDSf 2001-2003
EPA 515.2a
D5317-93b
AOAC 992.32c
4,4'-DDE............................... 72-55-9 EPA 508a 0.8 ug/Le EPTDSf 2001-2003
EPA 508.1a
EPA 525.2a
D5812-96b
AOAC 990.06c
EPTC................................... 759-94-4 EPA 507a 1 ug/Le EPTDSf 2001-2003
EPA 525.2a
D5475-93b
AOAC 991.07c
Molinate............................... 2212-67-1 EPA 507a 0.9 ug/Le EPTDSf 2001-2003
EPA 525.2a
D5475-93b
AOAC 991.07c
MTBE................................... 1634-04-4 EPA 524.2a 5 ug/Lg EPTDSf 2001-2003
D5790-95b
SM 6210Dd
SM 6200Bd
Nitrobenzene........................... 98-95-3 EPA 524.2a 10 ug/Lg EPTDSf 2001-2003
D5790-95b
SM6210Dd
SM6200Bd
Perchlorate............................ 14797-73-0 EPA 314.0 4 ug/Lo EPTDSf 2001-2003
Terbacil............................... 5902-51-2 EPA 507a 2 ug/Le EPTDSf 2001-2003
EPA 525.2a
D5475-93b
AOAC 991.07c
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
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 measured 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 contaminant.
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 and m 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 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.
aThe version of the EPA methods which you must follow for this Rule are listed at Sec. 141.24 (e).
bAnnual 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 Conshohocken, PA 19428.
cOfficial 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.
[[Page 11384]]
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
Examination of Water and Wastewater, 1998. Copies may be obtained from
the American Public Health Association, 1015 Fifteenth Street NW,
Washington, DC 20005.
eMinimum 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 method'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.
gMinimum 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 ug/L (0.0005 mg/L) was selected to conform to VOC MDL
requirements of 40 CFR 141.24(f)(17(E).
hTo be Determined at a later time.
iCompound currently not listed as a contaminant in this
method. Methods development currently being conducted in an attempt to
add it to the scope of this method.
jMethods development currently in progress to develop a
solid phase extraction/high performance liquid chromatography/
ultraviolet method for the determination of this compound.
kCompound 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.
lMethods development currently in progress to develop a
solid phase extraction /gas chromatography /mass spectrometry method
for the determination of this compound.
mMethod 314.0, ``Determination of Perchlorate in Drinking
Water Using Ion Chromatography,'' Revision 1.0, EPA 815-B-99-003,
November 1999. Available by requesting a copy from the EPA Safe
Drinking Water Hotline within the United States at (800) 426-4791
(Hours are Monday through Friday, excluding federal holidays, from 9:00
a.m. to 5:30 p.m. Eastern Time). Alternately, the method can be
assessed and downloaded directly on-line at www.epa.gov/safewater/methods/sourcalt.html.
nThe approved methods do not allow for the identification
and quantification of the individual acids, the single analytical
result obtained should be reported as total DCPA mono- and di-acid
degradates.
oMRL was established at a concentration, which is at least
1/4th the lowest known adverse health concentration, at which
acceptable precision and accuracy has been demonstrated in spiked
matrix samples.
* * * * *
(5) * * *
(ii) * * *
(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 (f)(1), (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 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.
* * * * *
(G) Testing. Except as provided in paragraph (a)(5)(ii)(G)(2) of
this section for new methods, you must arrange for the testing of the
contaminants by a laboratory certified under Sec. 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.
(1) Laboratory certification for previously approved methods used
for the UCMR. Laboratories are automatically certified for the analysis
of UCMR contaminants if they are already certified to conduct
compliance monitoring for a contaminant included in the same method
being approved for UCMR analysis.
(2) Laboratory approval for new methods used for the UCMR. To
receive approval to conduct analyses for perchlorate, you must be
certified to conduct compliance monitoring using an approved ion
chromatographic method as listed in Sec. 141.28 and you must analyze
and successfully pass the Performance Testing (PT) Program administered
by EPA.
(iii) * * *
(G) Sampling forms. You must completely fill out the sampling forms
sent to you by the laboratory, including the data elements 1 through 4
listed in Sec. 141.35(d) for each sample. If EPA requests that you
conduct field analysis of water quality parameters specified in
paragraph (a)(4)(i)(B) of this section, you must also complete the
sampling form to include the information for data elements 5 through 10
listed in Sec. 141.35(d) for each sample. You must sign and date the
sampling forms.
* * * * *
(b) * * *
(1) * * *
[[Page 11385]]
(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 correctly 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
system 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.
* * * * *
(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 monitoring for a contaminant with the sampling
location specified as ``distribution system''), 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.
* * * * *
[FR Doc. 00-4761 Filed 3-1-00; 8:45 am]
BILLING CODE 6560-50-P