Expedited Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe Drinking Water Act; Analysis and Sampling Procedures, 31616-31633 [E8-12198]
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Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Rules and Regulations
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Dated: May 12, 2008.
Bharat Mathur,
Acting Regional Administrator, Region 5.
List of Subjects in 40 CFR Part 52
Subpart Y—Minnesota
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Lead.
I
For the reasons stated in the preamble,
part 52, chapter I, of title 40 of the Code
of Federal Regulations is amended as
follows:
I
PART 52—[AMENDED]
1. The authority citation for part 52
continues to read as follows:
I
Authority: 42 U.S.C. 7401 et seq.
2. In § 52.1220 the table in paragraph
(e) is amended by adding an entry for
‘‘Lead Maintenance Plan’’ to read as
follows:
§ 52.1220
*
Identification of plan.
*
*
(e) * * *
*
*
EPA-APPROVED MINNESOTA NONREGULATORY PROVISIONS
Name of nonregulatory
SIP provision
*
Lead Maintenance
Plan.
*
*
*
*
Dakota County ............................................... 11/18/2002 and 11/19/
2007.
*
*
*
*
*
*
*
*
[FR Doc. E8–12240 Filed 6–2–08; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 141
[EPA–HQ–OW–2006–0958; FRL–8573–7]
Expedited Approval of Alternative Test
Procedures for the Analysis of
Contaminants Under the Safe Drinking
Water Act; Analysis and Sampling
Procedures
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
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publication in the Federal Register. EPA
is using this streamlined authority to
make 99 additional methods available
for analyzing drinking water samples
required by regulation. This expedited
approach provides public water
systems, laboratories, and primary
agencies with more timely access to new
measurement techniques and greater
flexibility in the selection of analytical
methods, thereby reducing monitoring
costs while maintaining public health
protection.
DATES:
This action is effective June 3,
2008.
Patricia Snyder Fair, Technical Support
Center, Office of Ground Water and
Drinking Water (MS 140),
Environmental Protection Agency, 26
West Martin Luther King Drive,
Cincinnati, OH 45268; telephone
number: (513) 569–7937; e-mail address:
fair.pat@epa.gov.
SUPPLEMENTARY INFORMATION:
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EPA approved date
Comments
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8/4/2008, [Insert page
number where the
document begins].
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Maintenance plan update.
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FOR FURTHER INFORMATION CONTACT:
SUMMARY: This action announces the
Environmental Protection Agency’s
(EPA’s) approval of alternative testing
methods for use in measuring the levels
of contaminants in drinking water and
determining compliance with national
primary drinking water regulations. The
Safe Drinking Water Act (SDWA)
authorizes EPA to approve the use of
alternative testing methods through
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effective date
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I. General Information
A. Does This Action Apply to Me?
Public water systems are the regulated
entities required to measure
contaminants in drinking water
samples. In addition, EPA Regions as
well as States and Tribal governments
with authority to administer the
regulatory program for public water
systems under SDWA may also measure
contaminants in water samples. When
EPA sets a monitoring requirement in its
national primary drinking water
regulations for a given contaminant, the
Agency also establishes in the
regulations standardized test procedures
for analysis of the contaminant. This
action makes alternative testing
methods available for particular
drinking water contaminants beyond the
testing methods currently established in
the regulations. Starting today, public
water systems required to test water
samples have a choice of using either a
test procedure already established in the
existing regulations or an alternative test
procedure that has been approved in
this action (or that is approved in
similar future actions). Categories and
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entities that may ultimately be affected
by this action include:
Category
State, Local, & Tribal Governments.
Industry ......................................
Municipalities ..............................
1 North
States, local and tribal governments that analyze water samples on behalf of public water systems required to conduct such analysis; States, local and tribal governments that themselves
operate community and non-transient non-community water systems required to monitor.
Private operators of community and non-transient non-community water systems required to
monitor.
Municipal operators of community and non-transient non-community water systems required to
monitor.
924110
221310
924110
American Industry Classification System.
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. This table lists
the types of entities that EPA is now
aware could potentially be affected by
this action. Other types of entities not
listed in the table could also be
impacted. To determine whether your
facility is affected by this action, you
should carefully examine the
applicability language at 40 CFR 141.2
(definition of public water system). If
you have questions regarding the
applicability of this action to a
particular entity, consult the person
listed in the preceding FOR FURTHER
INFORMATION CONTACT section.
B. How Can I Get Copies of This
Document and Other Related
Information?
1. Docket. EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OW–2006–0958. Publicly
available docket materials are available
either electronically through https://
www.regulations.gov or in hard copy at
the Water Docket in the EPA Docket
Center, (EPA/DC) EPA West, Room
3334, 1301 Constitution Ave., NW.,
Washington, DC. Copyrighted materials
are available only in hard copy. The
EPA Docket Center Public Reading
Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number
for the Public Reading Room is (202)
566–1744, and the telephone number for
the Water Docket is (202) 566–2426.
2. Electronic Access. You may access
this Federal Register document
electronically through the EPA Internet
under the Federal Register listings at
https://www.epa.gov/fedrgstr/.
Abbreviations and Acronyms Used in
This Action
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NAICS 1
Examples of potentially regulated entities
APHA: American Public Health Association
ASDWA: Association of State Drinking Water
Administrators
ATP: Alternate Test Procedure
AVICP-AES: Axially Viewed Inductively
Coupled Plasma-Atomic Emission
Spectrometry
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CFR: Code of Federal Regulations
EPA: Environmental Protection Agency
FEM: Forum on Environmental
Measurements
GWR: Ground Water Rule
HPLC: High-Performance Liquid
Chromatography
ITS: Industrial Test Systems, Inc.
LT2ESWTR: Long Term 2 Enhanced Surface
Water Treatment Rule
NEMI: National Environmental Method Index
SDWA: Safe Drinking Water Act
VCSB: Voluntary Consensus Standard Body
Table of Contents
I. General Information
A. Does This Action Apply to Me?
B. How Can I Get Copies Of This Document
and Other Related Information?
II. Background
A. What Is the Purpose of This Action?
B. What is the Basis for This Action?
C. Solicited Comments
D. Additional Comments
III. Summary of Approvals
A. Methods from Voluntary Consensus
Standard Bodies (VCSB)
B. Methods developed by EPA
C. Methods developed by Vendors
IV. Statutory and Executive Order Reviews
V. References
II. Background
A. What Is the Purpose of This Action?
In this action, EPA is approving 99
analytical methods for determining
contaminant concentrations in samples
collected under SDWA. Regulated
parties who are required to sample and
monitor may do so by using either the
testing methods already established in
existing regulations or the alternative
testing methods being approved in this
action. The new methods are listed in
Appendix A to Subpart C in 40 CFR 141
and on EPA’s drinking water methods
Web site at https://www.epa.gov/
safewater/methods/expedited.html. A
hard copy of the list of methods is also
available by calling the Safe Drinking
Water Hotline at (800) 426–4791.
B. What Is the Basis for This Action?
When EPA determines that an
alternative analytical method is
‘‘equally effective’’ (i.e., as effective as a
method that has already been
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promulgated in the regulations), SDWA
allows EPA to approve the use of the
alternative method through publication
in the Federal Register. See section
1401(1) of SDWA. EPA is using this
streamlined approval authority today to
make 99 additional methods available
for determining contaminant
concentrations in samples collected
under SDWA. EPA has determined that,
for each contaminant or group of
contaminants listed below, the
additional testing methods being
approved in this action are equally as
effective as one or more of the testing
methods already established in the
regulations for those contaminants.
Section 1401(1) states that the newly
approved methods ‘‘shall be treated as
an alternative for public water systems
to the quality control and testing
procedures listed in the regulation.’’
Accordingly, this action makes these
additional (and optional) 99 analytical
methods legally available for meeting
monitoring requirements.
This action does not add regulatory
language, but does, for informational
purposes, add an appendix to the
regulations at 40 CFR part 141 that lists
the newly approved methods.
Accordingly, while this action is not a
rule, it is adding CFR text and therefore
is being published in the ‘‘Final Rules’’
section of this Federal Register.
EPA described this expedited
methods approval process in an April
10, 2007, Federal Register notice (72 FR
17902) (USEPA 2007a) and announced
its intent to begin using the process.
EPA also solicited public comments on
some of the implementation aspects of
the process. EPA received comments
from seven States, two water systems,
the Association of Public Health
Laboratories, the Association of State
Drinking Water Administrators
(ASDWA), American Water Works
Association, a commercial vendor, a
manufacturing company, and an
anonymous person. The comments were
very supportive of the new approval
process. A summary of the most
significant public comments is
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presented in Section II.C and D. The
public docket for this action includes
the Agency’s complete response to
comments (USEPA, 2008).
C. Solicited Comments
1. Location of the comprehensive list
of methods approved under the
expedited process. In the April 10, 2007,
Federal Register notice (72 FR 17902)
(USEPA 2007a), EPA suggested three
potential places for listing all of the
alternative methods that EPA has
approved using this expedited process.
Public comments supported the use of
all three approaches (i.e., publishing as
an appendix in the Code of Federal
Regulations (CFR), posting on the EPA
Web site, and making available from a
designated Agency contact). The
National Environmental Method Index
(NEMI) was mentioned as an additional
mechanism for making the list available.
EPA is providing the list in all of the
suggested locations. First, this action
adds Appendix A to Subpart C of Part
141 (titled ‘‘Alternative Testing Methods
Approved for Analyses Under the Safe
Drinking Water Act’’) to the CFR. The
appendix provides the States with a
reference they can cite in their
regulations, as was requested by
ASDWA and others. EPA intends to
update the appendix each time
additional methods are approved using
the expedited process.
The EPA drinking water methods Web
site contains a new page that focuses on
the expedited methods approval process
https://www.epa.gov/safewater/methods/
expedited.html. The page contains a
link that allows users to download a
copy of the list of methods approved
using this process. The revision date
and reference to the CFR citation are
included on the list. Hard copies of the
list are also available from the Safe
Drinking Water Hotline.
EPA will continue to provide the
managers of NEMI with the information
needed to incorporate newly approved
methods into the NEMI database. EPA
methods are available for download
from the NEMI Web site (https://
www.nemi.gov) and information is
provided on the sources of any methods
that must be purchased.
2. Type of information included with
expedited approval decisions published
in the Federal Register. Almost
everyone who commented requested
that EPA provide information beyond a
listing of methods and the regulations to
which the methods apply. A summary
of the method, the method citation, and
the source for obtaining the method
were of greatest interest. EPA is
including the method citation and
source in the footnote section of the
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table that lists methods approved under
the expedited process. This format
ensures that the information is always
available with the list. EPA plans to
provide a summary of each new method
as part of the discussion in the Federal
Register that approves the method,
unless the method is an updated version
of a previously approved method (e.g.,
published in an earlier edition of
Standard Methods for the Analysis of
Water and Wastewater). In the latter
case, the original method will have
already been described. The approvals
are effective on the date of publication
in the Federal Register.
EPA intends to provide additional
information concerning the method
approval as part of the supporting
material in the docket for each action
that approves additional, alternative
methods using the expedited process. A
copy of each method being approved
will be included in the docket for the
action. Additional information will
generally include:
• The Alternative Test Procedures
(ATP) summary report for methods
evaluated under the ATP process;
• EPA method development report for
EPA methods (summary of experiments
conducted during method
development);
• A description of changes to the
original method for modified methods;
and
• Rationale for approval including:
• Summary of the performance
characteristics that relate to approval;
• Detection limits and/or minimum
reporting levels (MRLs) when they are a
regulatory requirement; and
• Benefits provided by the new
method.
In some cases, EPA may have already
promulgated more than one analytical
method for a particular contaminant. In
considering a new method for approval,
EPA may find that the new method has
performance characteristics that fall
within the range of more than one of the
existing promulgated methods. In those
cases, EPA may approve the new
method under the expedited process by
comparing its effectiveness to the group
of existing promulgated methods rather
than by reference to a single existing
method.
3. Amending regulatory text to
describe where the list of methods
approved using the expedited process is
found. Most commenters indicated it
would be helpful if the methods tables
in the regulations include a reference to
the list of additional, alternative
methods approved under the expedited
process. The commenters provided
mixed reactions to adding the same
information at 40 CFR 141.27. EPA is
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considering adding the requested
references to the CFR text as part of a
future regulatory action.
Some commenters wanted EPA to
publish a comprehensive list of all
approved drinking water methods. A
few suggested that EPA incorporate the
alternative methods approved under the
expedited method approval process into
the regulations when the methods tables
are updated.
EPA understands the desire to have
all methods listed together. As a result,
EPA is revising the drinking water
methods Web site (https://www.epa.gov/
safewater/methods/methods.html) to
address this request. The user will be
able to download comprehensive lists
organized by regulation/monitoring
requirement (e.g., Ground Water Rule,
Unregulated Contaminant Monitoring
Rule, Organic Contaminant Monitoring,
etc.). Each list will include the drinking
water methods authorized in the
regulation and the alternative methods
approved via the expedited process. The
revision date and CFR citations will be
included on each list. EPA believes that
making the comprehensive lists
available on the Internet provides more
timely access to the information in the
requested format than amending the
methods tables in the regulations would
provide.
4. Format of the table that lists
methods approved using the expedited
approval process. Most commenters
indicated the table format presented in
the April 10, 2007, Federal Register
notice (72 FR 17902) (USEPA 2007a) is
acceptable. One commenter suggested
that the contaminants be listed
alphabetically in the first column of the
table in order to be consistent with the
methods tables in the regulation, while
also providing a listing of all methods
for a single contaminant together. The
commenter also requested that the table
be completely updated each time new
approvals are made instead of
appending new approvals to the end of
the table.
EPA is incorporating several of the
suggestions into the final table format.
The table is organized by contaminant
in order to improve stakeholder access
to the information. The table is divided
into sections so that the format mimics
the methods tables in 40 CFR 141 and
143. In future expedited method
approval actions, EPA will also
incorporate new methods into the table
rather than appending them onto the
end in order to maintain the format.
Appendix A to Subpart C of Part 141
contains the same type of information as
was presented in the April 10, 2007,
notice. Additional information
regarding the newly approved,
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alternative methods is included in the
Federal Register preamble and in the
docket as part of the background
information concerning the approvals.
In the future, if EPA withdraws
approval for a method that was
approved via the expedited process, the
Agency intends to update the table at
Appendix A to Subpart C of Part 141 to
reflect both the approval and
withdrawal dates for the method in
question.
5. State implementation of methods
approved under the expedited process.
States’ approaches to allowing use of
methods approved under the expedited
process will vary. Some States will need
to incorporate the expedited process
into their regulations while other States
may allow the use of the methods as
soon as laboratories become certified to
use them. Some State certification
programs are able to adopt methods as
soon as EPA approves them. This
variability in implementation
approaches means some States will be
able to adopt methods approved under
the expedited process more quickly than
other States. Although this variability
was mentioned in the comments, this
situation is not unique to methods
approved using the expedited process; it
is also a factor for methods approved via
rulemaking.
One approach that EPA is using to
assist States is to add an appendix in the
CFR that lists all alternative methods
approved using the expedited process.
States can cite this appendix (Appendix
A to Subpart C in 40 CFR 141) when
they update their regulations.
EPA is also making a copy of the
appendix available on a Web page
https://www.epa.gov/safewater/methods/
expedited.html. Some States may be
able to cite the URL as a source for
alternative methods approved under the
expedited process.
Some States requested early access to
information about methods that are
under consideration for approval in
order to provide more time to adopt
EPA-approved methods. EPA will
consider this request as it implements
the expedited process. Early sharing of
information with States would give
them additional time to prepare for
adopting new analytical methods after
they are published in the Federal
Register.
State adoption of alternative methods
approved under the expedited process is
optional. States may choose to allow
only a more limited set of methods to
be used for compliance. States that
choose to allow the alternative methods
approved through this expedited
process will be consistent with the
requirement that States must have
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programs at least as stringent as the
Federal drinking water program in order
to have primary enforcement
responsibility for the drinking water
program.
When the regulation requires that the
laboratory be certified to perform
analyses of samples for a specific
contaminant, then this requirement
extends to the use of methods approved
through the expedited process. This
means the States that choose to allow
these alternative methods will need to
develop certification criteria, train
auditors, and evaluate laboratory
capabilities for using the newly
approved methods. EPA expects that
State certification programs will
incorporate methods approved using the
expedited process into their programs in
the same manner as methods that are
approved using rulemaking. If the
method is an updated version or a slight
modification of a previously approved
method, then an abbreviated
certification process may be applicable.
The approval of methods, whether
under rulemaking or the expedited
approach, presents similar challenges to
the Agency and the States. The approval
decisions must be conveyed to the
appropriate persons within the States.
EPA plans to disseminate information
concerning future method approvals
using several approaches. A copy of the
Federal Register action will be sent to
the State drinking water certification
and program offices. The Safe Drinking
Water Hotline will have information
concerning the approvals and
information will be posted on EPA’s
drinking water methods Web page.
Withdrawal of method approval is a
rare event under the regulatory process
and EPA expects its occurrence under
the expedited process will also be very
limited. Methods will generally be
withdrawn using the same process as
was used for their approval. Methods
approved via the expedited process will
generally be withdrawn using the
expedited process; methods approved
under rulemaking will be withdrawn
using rulemaking. Soliciting public
comment through a rule proposal and
issuing a final rule after taking those
comments into consideration provides
the States with time to withdraw the
methods from their programs. In order
to provide a comparable timeframe
under the expedited process, EPA plans
to consult with the States prior to
establishing effective dates for
withdrawal of methods under the
expedited process. It is important that
the effective date provide time for the
States to implement withdrawal, so that
States will not be in a position of
allowing methods that were
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disapproved by EPA. The appendix in
the CFR will reflect both the approval
and withdrawal dates for any method
that is withdrawn using the expedited
process. Citing both dates will eliminate
any confusion as to when/whether a
method approval is in effect.
D. Additional Comments
The April 10, 2007, Federal Register
notice solicited comments on the
process used by EPA to announce the
approval of alternative methods to the
methods listed in regulation. EPA also
received comments that are indirectly
related to the expedited method
approval process. Brief discussions of
the major topics are presented below.
All of the comments and the Agency’s
response to comments (USEPA 2008)
are available in the docket for this
action.
1. EPA evaluation process. The
expedited approval process allows EPA
to approve methods more quickly and
commenters support more timely
approval of methods. However,
shortening the approval process raised
the question about whether EPA is
changing the way that it evaluates
methods prior to issuing approval
decisions. Some commenters asked that
EPA maintain its high standards for
evaluating methods. Other commenters
provided recommendations for changing
the review process in order to both
streamline and strengthen it.
The evaluation process is separate
from the expedited approval process.
EPA is open to improving our
evaluation process and to making the
process as transparent as possible. EPA
appreciates the suggestions and will
consider them with any future
evaluation of potential improvements to
the ATP program. EPA notes that some
of the requested changes are already
included in our current evaluation
protocol. For example, minor
modifications to existing methods
generally do not require extensive data
submissions in order to demonstrate
acceptable method performance.
2. Prioritization of method
evaluations. EPA recognizes that the
ability to approve methods more quickly
may result in an increase in the number
of methods that are submitted to EPA
for evaluation. It was suggested that
EPA prioritize method reviews so that
methods that provide the greatest
benefit are evaluated first. EPA agrees
with this approach and intends to give
new methods that provide significant
advantages over currently approved
methods higher priority in the review
process. Improvements may be in areas
such as waste minimization, reduced
analysis time, cost reduction, increased
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method flexibility, introduction of an
innovative technology, etc.
Implementation of this approach means
that new methods will not necessarily
be reviewed/approved in the order in
which they are submitted to the Agency.
3. Public comment as part of the
method approval process. EPA
understands the desire for the public to
have an opportunity to comment on
methods approved under the expedited
approval process. However, introducing
a comment period on these alternative
methods is not consistent with the
expedited process intended by
Congress; as a result, EPA does not
generally plan to solicit comment on
these alternative method approval
decisions.
The purpose of this alternative
procedure is to identify and allow the
use of methods that are equally as
effective as methods already approved
in prior regulations. As a result, the
benchmark for these alternatives has
already been provided through noticeand-comment rulemaking on the
original method(s). In addition, this
expedited approval process simply
provides a broader set of compliance
opportunities for water systems. Finally,
EPA expects to use the expedited
process only for those alternative
methods that are clearly equally
effective relative to methods already
approved through regulation and that
have performance that has been fully
evaluated and well documented, as
discussed below.
EPA methods undergo peer review
prior to publication. The experimental
results obtained during method
development are usually summarized in
a report that is included in the docket
when the method is approved. The EPA
method development research is often
published in a peer reviewed journal. In
addition, new chemical and
radiochemical methods developed by
EPA are evaluated according to Agency
guidance adopted by the EPA Forum on
Environmental Measurements (FEM).
(USEPA 2005, 2006a) The method
validation principles are based on
current, international approaches and
guidelines for intralaboratory (single
laboratory) and interlaboratory (multiple
laboratory) method validation studies.
The Agency is developing similar
guidance for validation of
microbiological methods and that
guidance will be adopted when it
becomes available.
EPA plans to extend the use of the
FEM guidance to methods that are
reviewed under the ATP program. EPA
encourages method developers to
consult with the ATP coordinator
during the development of their ATP
study plans so that the experimental
designs incorporate the appropriate
tests. EPA intends to work with method
developers during this consultation
process to be sure that their ATP study
plans address the principles outlined in
the validation guidance. In addition,
EPA plans to solicit external scientific
review for ATP methods that involve
new technology. The docket will
contain the ATP study summary report
and the external scientific review
comments in order to document the
basis for EPA’s approval decision. If the
method developer submits confidential
business information as part of the ATP
review process, the information will not
be included in the docket.
Generally-accepted validation
principles are usually followed for
methods that are developed by
Voluntary Consensus Standard Bodies
(VCSBs), such as Standard Methods and
ASTM, International. When a new
method is adopted by a VCSB, EPA
reviews the data generated during
development and validation to verify
the method is suitable for analyzing
drinking water samples. EPA plans to
use the expedited method approval
process for methods that perform as
well as the regulatory methods. The
supporting data that EPA uses to make
the approval determination will be
placed in the docket so that the
information is publically available.
In unique cases in which EPA
believes public comment is warranted
prior to approval, EPA may solicit
comment through a notice and then
issue its decision on approving the
alternative method after taking the
comments into consideration.
4. Methods recommended for
approval. In the April 10, 2007, Federal
Register notice (72 FR 17902) (USEPA
2007a), EPA included two examples of
methods that were being considered for
approval using the expedited approval
process. Commenters supported the
approval of these methods (i.e., EPA
Method 200.5 and Standard Method
6610–04). They also recommended
additional methods for consideration.
EPA has enough information to make
approval determinations for many of the
methods that were listed in the public
comments. In those cases, EPA is
approving them as part of this action.
Additional approval decisions are
pending submission of data that will
allow EPA to further compare the new
methods’ performance to that obtained
by the regulatory methods.
III. Summary of Approvals
EPA is approving 99 methods, 85 of
which are identical to previously
approved methods from earlier
publications and 14 of which represent
new or modified methods. EPA notes
that the approval for all of these
methods, including the 85 ‘‘identical’’
methods previously required a noticeand-comment rulemaking action.
A. Methods From Voluntary Consensus
Standard Bodies (VCSB)
1. Standard Methods. EPA approved
73 methods in ‘‘Standard Methods
Online’’ as part of a ‘‘Methods Update
Rule’’ issued on March 12, 2007 (72 FR
11200) (USEPA 2007b). Identical
versions of these methods are also
published in the 21st edition of
Standard Methods for the Analysis of
Water and Wastewater (Walker and
Wendelken 2007). EPA recognizes that
some States and laboratories prefer the
hardcopy version to the electronic
version that was previously approved.
Since the 21st edition versions of these
methods are equally effective relative to
the online versions, EPA is approving
the 73 methods from the 21st edition in
this action. The 21st edition (APHA
2006) can be purchased from American
Public Health Association (APHA), 800
I Street, NW., Washington, DC 20001–
3710.
Six methods were published in
‘‘Standard Methods Online’’ too late to
be included in the March 12, 2007,
Methods Update Rule. These methods
are also included in the 21st edition of
Standard Methods for the Analysis of
Water and Wastewater (APHA 2006).
Four of the methods are unchanged and
the other two updated methods reflect
minor editorial changes to the versions
published in the 20th edition of
Standard Methods which are approved
at 40 CFR 141.23 and 143.4 (Fair 2008a).
EPA is approving the following methods
because they are equally effective
relative to the currently approved
versions:
SM (21st ed)
(APHA 2006)
Standard methods online
Contaminant
4500–P E .........................
4500–P F .........................
4500–P E–99 (APHA 1999) ....................................
4500–P F–99 (APHA 1999) ....................................
Orthophosphate ......................
Orthophosphate ......................
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40 CFR 141.23(k)(1).
40 CFR 141.23(k)(1).
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SM (21st ed)
(APHA 2006)
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4500–SO4¥2
4500–SO4¥2
4500–SO4¥2
4500–SO4¥2
C ................
D ................
E ................
F .................
Standard methods online
4500–SO4¥2 C–97 (APHA 1997a) .........................
4500–SO4¥2 D–97 (APHA 1997a) .........................
4500–SO4¥2 E–97 (APHA 1997a) .........................
4500–SO4¥2 F–97 (APHA 1997a) ..........................
The 21st edition can be obtained from
APHA, 800 I Street, NW., Washington,
DC 20001–3710 and the Online methods
can be purchased at https://
www.standardmethods.org.
The November 8, 2006, Ground Water
Rule (GWR) (71 FR 65653) (USEPA
2006b) approved Colilert and Colisure
media (Standard Method 9223 B, 20th
Edition) for determining the presence of
E. coli. Those two E. coli media, along
with a third medium, Colilert-18 (all
part of SM 9223B), were listed in Table
IV–1 of the preamble as being approved
in the rule. However, due to a
publication oversight, the Colilert-18
methodology was omitted in the table at
40 CFR 141.402(c)(2). EPA is using this
expedited approval action to correct the
inconsistency between the preamble
and rule language and clarify the status
of Colilert-18 as an approved
methodology. Colilert-18, as described
in Standard Method 9223 B and
published in the 20th edition of
Standard Methods for the Analysis of
Water and Wastewater (APHA 1998), is
equally as effective as the previously
promulgated Colilert and Colisure
media in Standard Method 9223 B (page
65593 of the GWR preamble, USEPA
2006c) and is therefore approved in this
action. Accordingly, EPA is adding the
Colilert-18 methodology to the list of
approved methods in Appendix A to
Subpart C of Part 141.
Identical versions of Standard Method
9223 B are published in the 20th and
21st editions of Standard Methods for
the Analysis of Water and Wastewater
and in ‘‘Standard Methods Online’’ (Fair
2008a). Because the methods from all
three sources are equally effective, EPA
is approving the 21st edition and the
1997 online version of Method 9223 B
for the Colilert, Colisure, and Colilert-18
methodologies. These newer versions
are equally effective relative to the
methods cited at 40 CFR 141.402(c)(2).
The 21st edition of Standard Methods
(APHA 2006) can be obtained from
APHA, 800 I Street, NW., Washington,
DC 20001–3710 and Standard Method
9223 B–97 (APHA 1997b) can be
purchased at https://
www.standardmethods.org.
EPA approved Standard Method 9230
B in the 20th edition of Standard
Methods for the Analysis of Water and
Wastewater as one of the methods for
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....................................
....................................
....................................
determining Enterococci under the GWR
(71 FR 65653) (USEPA 2006b). The
online version of this method (9230 B–
04) is identical to the version published
in the 20th edition (Fair 2008a). EPA is
approving Standard Method 9230 B–04
(APHA 2004b) for Enterococci
detection, because it is equally effective
relative to the methods cited at
141.402(c)(2). The online method can be
purchased at https://
www.standardmethods.org.
The January 5, 2006, Long Term 2
Enhanced Surface Water Treatment Rule
(LT2ESWTR) (71 FR 654) (USEPA
2006c) established source water
monitoring requirements for E. coli. It
approved the same methods for E. coli
that are approved for ambient water
monitoring under 40 CFR 136.3. The
preamble in the LT2ESWTR proposal
(68 FR 47640, August 11, 2003) (USEPA
2003a) listed the E. coli methods in the
same format as they were presented in
the proposed Guidelines Establishing
Test Procedures for the Analysis of
Pollutants; Analytical Methods for
Biological Pollutants in Ambient Water
(66 FR 45811, August 30, 2001) (USEPA
2001a). Two membrane filter methods
(Standard Methods 9222 B and 9222 D)
used in conjunction with Standard
Method 9222 G to enumerate E. coli
were listed in both proposals. When the
final Guidelines Establishing Test
Procedures for the Analysis of
Pollutants; Analytical Methods for
Biological Pollutants in Ambient Water
(68 FR 43272, July 21, 2003) (USEPA
2003b) was published, the methods
table at 40 CFR 136.3 was published in
a different format from the proposal.
Standard Method 9222 D/9222 G was
listed as two step membrane filtration in
the table of approved methods and
footnote 19 in the table indicated other
membrane filter procedures could be
used prior to Standard Method 9222 G.
Since Standard Method 9222 D is not
explicitly listed in the final rule, there
is some confusion as to whether
Standard Method 9222 D is acceptable
for the membrane filtration step. The
July 21, 2003, preamble (USEPA 2003b)
stated that the final rule was
promulgating the test methods
described in the proposed rule, and
there was no reason presented to
exclude Standard Method 9222 D
published in the 20th edition of
31621
40
40
40
40
CFR
CFR
CFR
CFR
143.4(b).
143.4(b).
143.4(b).
143.4(b).
Standard Methods for the Analysis of
Water and Wastewater (APHA 1998) as
an approved method. Therefore, EPA is
using this expedited method approval
process to clarify that Standard Method
9222 D in combination with 9222 G is
approved for enumerating E. coli under
the LT2ESWTR. Standard Method 9222
D/9222 G is equally as effective as other
promulgated methods for enumerating
E. coli (USEPA 2001a). Accordingly,
EPA is adding Standard Method 9222 D/
9222 G published in the 20th edition of
Standard Methods for the Analysis of
Water and Wastewater (APHA 1998) to
the list of approved methods in
Appendix A to Subpart C of Part 141.
The April 10, 2007, Federal Register
notice (72 FR 17902) (USEPA 2007a)
listed Standard Method 6610–04 (APHA
2004a) as a potential candidate for
approval under the expedited approval
process. This new Standard Method
uses high-performance liquid
chromatography (HPLC) with postcolumn derivatization and fluorescence
detection to determine carbamate
pesticide concentrations in drinking
water. After the addition of a surrogate
compound and filtration, water samples
are injected directly onto an HPLC and
separated by use of a gradient and a C18
column. The 11 carbamate pesticides
that are analyzed by this method are
generally classified as phenyl and oxime
carbamates and have an N-methyl group
in common. After chromatographic
separation, the compounds are
hydrolyzed with 0.05N sodium
hydroxide at 80 to 95 °C, yielding a
methyl amine which is then reacted
with o-phthalaldehyde and 2mercaptoethanol to form a highly
fluorescent isoindole that is detected
instrumentally. The method is
applicable to carbofuran and oxamyl,
which are regulated in drinking water.
The method uses the same chemistry
and quality control criteria as EPA
Method 531.2 (USEPA 2001b), which is
approved for analyzing compliance
samples for carbofuran and oxamyl (40
CFR 141.24(e)(1)). EPA is approving
Standard Method 6610–04 (APHA
2004a) for the analysis of compliance
samples for carbofuran and oxamyl,
because it is equally effective relative to
EPA Method 531.2 (Fair 2008a). EPA is
also approving the identical version of
Standard Method 6610 that is published
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in the 21st edition of Standard Methods
for the Analysis of Water and
Wastewater (APHA 2006). EPA
recognizes that this method may be used
to determine concentrations of
additional compounds for which there
are no Federal monitoring requirements.
2. ASTM International. EPA
compared new versions of six ASTM
methods to the most recent versions of
those methods cited in 40 CFR 141 and
143. The new versions included changes
such as:
• More detailed quality control
sections (D 512–04 B and D 1179–04 B);
• Additional choices in equipment or
reagents (D 859–05, D 1179–04 B, and
D 2036–06 A and B);
• More stringent reagent water
specifications (D 512–04 B and D 859–
05);
• Additional instructions for
handling interferences (D 2036–06 A
and B);
• Modifications to allow analysis of
additional types of samples (D 5673–
05); and
• Editorial changes in all methods
(changes in references, reorganization,
corrections of errors).
Data generated using the new
methods are comparable to data
obtained using the previous versions
because the chemistry and samplehandling protocols are unchanged. The
new versions are equally effective
relative to the version cited in
regulation. (Fair, 2008a) Thus, EPA is
approving the use of these six ASTM
methods:
ASTM method
Contaminant
D512–04 B (ASTM International 2004a) ........................................................
D859–05 (ASTM International 2005a) ...........................................................
D1179–04 B (ASTM International 2004b) ......................................................
D2036–06 A (ASTM International 2006) ........................................................
D2036–06 B (ASTM International 2006) ........................................................
D5673–05 (ASTM International 2005b) .........................................................
Chloride .............................................
Silica ..................................................
Fluoride ..............................................
Cyanide ..............................................
Cyanide ..............................................
Uranium .............................................
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The ASTM methods are available from
ASTM International, 100 Barr Harbor
Drive, West Conshohocken, PA 19428–
2959 or https://www.astm.org.
B. Methods Developed by EPA
1. EPA Method 200.5, Revision 4.2.
EPA described this method as a
candidate for approval under the
expedited approval program in the April
10, 2007, Federal Register notice (72 FR
17902) (USEPA 2007a). Commenters
were universally supportive of method
approval.
EPA Method 200.5 (USEPA 2003c)
uses axially viewed inductively coupled
plasma-atomic emission spectrometry
(AVICP–AES) to determine
concentrations of 22 trace elements and
contaminants in drinking water. The
method involves the following steps:
• Sample digestion;
• Volume reduction to provide a 2X
concentration; and
• Multi-elemental determinations by
axially viewed inductively coupled
plasma-atomic emission spectrometry
(AVICP–AES) using sequential or
simultaneous instruments. The
instruments measure characteristic
atomic-line emission spectra by optical
spectrometry.
Approved methods for 19 of the EPA
Method 200.5 analytes are listed at 40
CFR 141.23(k)(1) and 40 CFR 143.4. The
performance characteristics of EPA
Method 200.5, Revision 4.2 were
compared to the characteristics of the
methods listed at 40 CFR 141.23(k)(1)
for antimony, arsenic, barium,
beryllium, cadmium, calcium,
chromium, copper, lead, magnesium,
nickel, selenium, silica, and sodium.
The performance characteristics of EPA
Method 200.5, Revision 4.2 were
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compared to the characteristics of the
methods listed at 40 CFR 143.4 for
aluminum, iron, manganese, silver, and
zinc (Fair 2008b). Since EPA Method
200.5 is equally effective relative to the
methods already promulgated in the
regulations, EPA is approving it for
determining aluminum, antimony,
arsenic, barium, beryllium, cadmium,
calcium, chromium, copper, iron, lead,
magnesium, manganese, nickel,
selenium, silica, silver, sodium, and
zinc concentrations in drinking water to
comply with 40 CFR 141.23 and 143.4.
EPA Method 200.5, Revision 4.2
(USEPA 2003c) can be accessed and
downloaded directly on-line at https://
www.epa.gov/nerlcwww/ordmeth.htm.
C. Methods Developed by Vendors
1. Method D99–003, Revision 3.0. If
approved by the State, 40 CFR
141.74(a)(2) allows the use of DPD
colorimetric test kits to determine
disinfectant residuals. Evaluation of the
free chlorine test strip method, Method
D99–003 (Industrial Test Systems, Inc.
2003), under the ATP program
demonstrated performance
characteristics similar to those obtained
using DPD colorimetric test kits. As a
result, the March 12, 2007, Methods
Update Rule (72 FR 11200) (USEPA
2007b) added language at 40 CFR
141.74(a)(2) to allow the use of Method
D99–003 developed by Industrial Test
Systems, Inc. (ITS) to determine free
chlorine residuals in drinking water, if
approved by the State. This approval
was specified for systems monitoring
under the requirements of 40 CFR 141
Subpart H.
In a similar manner, 40 CFR
141.131(c)(2) allows the State to
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40
40
40
40
40
40
CFR
CFR
CFR
CFR
CFR
CFR
143.4(b).
141.23(k)(1).
141.23(k)(1).
141.23(k)(1).
141.23(k)(1).
141.25(a).
approve the use of DPD colorimetric test
kits for monitoring requirements
specified at 40 CFR 141.132(c)(1). The
free chlorine test strip method is not
listed. As noted, however, evaluation of
the chlorine test strip method has
demonstrated performance
characteristics similar to those obtained
using DPD colorimetric test kits.
Accordingly, the chlorine test strip
method is an equally effective
methodology, and there is no technical
reason to withhold approval under one
rule while allowing its use under a
separate regulation. Therefore, EPA is
using this action to approve the use of
Method D99–003 (ITS 2003) to meet free
chlorine residual monitoring
requirements specified at 40 CFR
141.132(c)(1), if approved by the State.
Method D99–003, Revision 3.0, titled
‘‘Free Chlorine Species (HOCl¥ and
OCl¥) by Test Strip,’’ November 21,
2003, is available from Industrial Test
Systems, Inc., 1875 Langston St., Rock
Hill, SC 29730. The ATP report on this
method is contained in the docket for
the March 12, 2007, Methods Update
Rule.
IV. Statutory and Executive Order
Reviews
As noted above, under the terms of
SDWA Section 1401(1), this streamlined
method approval action is not a rule.
Accordingly, the Congressional Review
Act, 5 U.S.C. 801 et seq., as added by
the Small Business Regulatory
Enforcement Fairness Act of 1996, does
not apply because this action is not a
rule for purposes of 5 U.S.C. 804(3).
Similarly, this action is not subject to
the Regulatory Flexibility Act because it
is not subject to notice and comment
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requirements under the Administrative
Procedure Act or any other statute. In
addition, because this approval action is
not a rule but simply makes alternative
(optional) testing methods available for
monitoring under SDWA, EPA has
concluded that other statutes and
executive orders generally applicable to
rulemaking do not apply to this
approved action.
V. References
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APHA. 1997a. Standard Method 4500–
SO4¥2–97. Sulfate. Approved by Standard
Methods Committee 1997. Standard Methods
Online. (Available at https://
www.standardmethods.org.).
APHA. 1997b. Standard Method 9223 B–
97. Enzyme Substrate Coliform Test.
Approved by Standard Methods Committee
1997. Standard Methods Online. (Available
at https://www.standardmethods.org.).
APHA. 1998. Twentieth Edition of
Standard Methods for the Examination of
Water and Wastewater, American Public
Health Association, 800 I Street, NW,
Washington, DC 20001–3710.
APHA. 1999. Standard Method 4500–P–99.
Phosphorus. Approved by Standard Methods
Committee 1999. Standard Methods Online.
(Available at https://
www.standardmethods.org.)
APHA. 2004a. Standard Method 6610–04.
Carbamate Pesticides—High-Performance
Liquid Chromatographic Method. Approved
by Standard Methods Committee 2004.
Standard Methods Online. (Available at
https://www.standardmethods.org.)
APHA. 2004b. Standard Method 9230 B–
04. Fecal Enterococcus/Streptococcus
Groups—Multiple-Tube Technique.
Approved by Standard Methods Committee
2004. Standard Methods Online. (Available
at https://www.standardmethods.org.)
APHA. 2006. Twenty-first Edition of
Standard Methods for the Examination of
Water and Wastewater, American Public
Health Association, 800 I Street, NW.,
Washington, DC 20001–3710.
ASTM International. 2004a. Method D
512–04 B. Standard Test Method for Chloride
Ion in Water by Silver Nitrate Titration.
ASTM International, 100 Barr Harbor Drive,
West Conshohocken, PA 19428–2959.
(https://www.astm.org)
ASTM International. 2004b. Method D
1179–04B. Standard Test Method for
Fluoride Ion in Water by Ion Selective
Electrode. ASTM International, 100 Barr
Harbor Drive, West Conshohocken, PA
19428–2959. (https://www.astm.org)
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ASTM International. 2005a. Method D
859–05. Standard Test Method for Silica in
Water. ASTM International, 100 Barr Harbor
Drive, West Conshohocken, PA 19428–2959.
(https://www.astm.org)
ASTM International. 2005b. Method D
5673–05. Standard Test Method for Elements
in Water by Inductively Coupled PlasmaMass Spectrometry. ASTM International, 100
Barr Harbor Drive, West Conshohocken, PA
19428–2959. (https://www.astm.org)
ASTM International. 2006. Method D
2036–06. Standard Test Method for Cyanides
in Water. ASTM International, 100 Barr
Harbor Drive, West Conshohocken, PA
19428–2959. (https://www.astm.org)
Fair, P., 2008a. Memo to the record
describing basis for approving methods from
Standard Methods and ASTM International.
April 2008.
Fair, P., 2008b. Memo to the record
describing basis for approving EPA Method
200.5. April 2008.
Industrial Test Systems, Inc. 2003. Method
D99–003. Free Chlorine Species (HOCl
and OCl ) by Test Strip, Revision 3.0,
November 21, 2003. Industrial Test Systems,
Inc., 1875 Langston St., Rock Hill, SC 29730.
USEPA. 2001a. Guidelines Establishing
Test Procedures for the Analysis of
Pollutants; Analytical Methods for Biological
Pollutants in Ambient Water; Proposed Rule.
66 FR 45811. August 30, 2001.
USEPA. 2001b. EPA Method 531.2.
Measurement of N-methylcarbamoyloximes
and N-methylcarbamates in Water by Direct
Aqueous Injection HPLC with Postcolumn
Derivatization. Revision 1.0. EPA 815–B–01–
002 (Available at https://www.epa.gov/
safewater/methods/sourcalt.html.)
USEPA. 2003a. National Primary Drinking
Water Regulations: Long Term 2 Enhanced
Surface Water Treatment Rule; Proposed
Rule. 68 FR 47640. August 11, 2003.
USEPA. 2003b. Guidelines Establishing
Test Procedures for the Analysis of
Pollutants; Analytical Methods for Biological
Pollutants in Ambient Water; Final Rule. 68
FR 43272. July 21, 2003.
USEPA. 2003c. EPA Method 200.5.
Determination of Trace Elements in Drinking
Water by Axially Viewed Inductively
Coupled Plasma-Atomic Emission
Spectrometry. Revision 4.2. EPA/600/R–06/
115. (Available at https://www.epa.gov/
nerlcwww/ordmeth.htm.)
USEPA. 2005. Validation and Peer Review
of U.S. Environmental Protection Agency
Chemical Methods of Analysis, FEM
Document Number 2005–01, October 2005.
USEPA. 2006a. Validation and Peer Review
of U.S. Environmental Protection Agency
Radiochemical Methods of Analysis, FEM
Document Number 2006–01, August 2006.
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USEPA. 2006b. National Primary Drinking
Water Regulations: Ground Water Rule. 71
FR 65574. November 8, 2006.
USEPA. 2006c. National Primary Drinking
Water Regulations: Long Term 2 Enhanced
Surface Water Treatment Rule; Final Rule. 71
FR 654. January 5, 2006.
USEPA. 2007a. Expedited Approval of Test
Procedures for the Analysis of Contaminants
Under the Safe Drinking Water Act; Analysis
and Sampling Procedures. 72 FR 17902.
April 10, 2007.
USEPA. 2007b. Guidelines Establishing
Test Procedures for the Analysis of Pollutants
Under the Clean Water Act; National Primary
Drinking Water Regulations; and National
Secondary Drinking Water Regulations;
Analysis and Sampling Procedures; Final
Rule. 72 FR 11200. March 12, 2007.
USEPA. 2008. Response to Comments
Document for Expedited Approval of Test
Procedures for the Analysis of Contaminants
Under the Safe Drinking Water Act; Analysis
and Sampling Procedures (72 FR 17902.
April 10, 2007). May 2008.
Walker, L. and Wendelken, S., 2007. Letter
to S. Posavec, Standard Methods Manager,
April 11, 2007.
List of Subjects in 40 CFR Part 141
Environmental protection, Chemicals,
Indians-lands, Intergovernmental
relations, Radiation protection,
Reporting and recordkeeping
requirements, Water supply.
Dated: May 20, 2008.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
For the reasons stated in the preamble,
40 CFR part 141 is amended as follows:
I
PART 141—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
1. The authority citation for part 141
continues to read as follows:
I
Authority: 42 U.S.C. 300f, 300g–1, 300j–4,
and 300j–9.
2. Subpart C is amended by adding
Appendix A to read as follows:
I
Appendix A to Subpart C of Part 141—
Alternative Testing Methods Approved
for Analyses Under the Safe Drinking
Water Act.
Only the editions stated in the following
table are approved.
BILLING CODE 6560–50–P
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[FR Doc. E8–12198 Filed 6–2–08; 8:45 am]
]]>Agencies
[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Rules and Regulations]
[Pages 31616-31633]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12198]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 141
[EPA-HQ-OW-2006-0958; FRL-8573-7]
Expedited Approval of Alternative Test Procedures for the
Analysis of Contaminants Under the Safe Drinking Water Act; Analysis
and Sampling Procedures
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This action announces the Environmental Protection Agency's
(EPA's) approval of alternative testing methods for use in measuring
the levels of contaminants in drinking water and determining compliance
with national primary drinking water regulations. The Safe Drinking
Water Act (SDWA) authorizes EPA to approve the use of alternative
testing methods through publication in the Federal Register. EPA is
using this streamlined authority to make 99 additional methods
available for analyzing drinking water samples required by regulation.
This expedited approach provides public water systems, laboratories,
and primary agencies with more timely access to new measurement
techniques and greater flexibility in the selection of analytical
methods, thereby reducing monitoring costs while maintaining public
health protection.
DATES: This action is effective June 3, 2008.
FOR FURTHER INFORMATION CONTACT: Patricia Snyder Fair, Technical
Support Center, Office of Ground Water and Drinking Water (MS 140),
Environmental Protection Agency, 26 West Martin Luther King Drive,
Cincinnati, OH 45268; telephone number: (513) 569-7937; e-mail address:
fair.pat@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
Public water systems are the regulated entities required to measure
contaminants in drinking water samples. In addition, EPA Regions as
well as States and Tribal governments with authority to administer the
regulatory program for public water systems under SDWA may also measure
contaminants in water samples. When EPA sets a monitoring requirement
in its national primary drinking water regulations for a given
contaminant, the Agency also establishes in the regulations
standardized test procedures for analysis of the contaminant. This
action makes alternative testing methods available for particular
drinking water contaminants beyond the testing methods currently
established in the regulations. Starting today, public water systems
required to test water samples have a choice of using either a test
procedure already established in the existing regulations or an
alternative test procedure that has been approved in this action (or
that is approved in similar future actions). Categories and
[[Page 31617]]
entities that may ultimately be affected by this action include:
----------------------------------------------------------------------------------------------------------------
Category Examples of potentially regulated entities NAICS \1\
----------------------------------------------------------------------------------------------------------------
State, Local, & Tribal Governments.............. States, local and tribal governments that analyze 924110
water samples on behalf of public water systems
required to conduct such analysis; States, local
and tribal governments that themselves operate
community and non-transient non-community water
systems required to monitor.
Industry........................................ Private operators of community and non-transient 221310
non-community water systems required to monitor.
Municipalities.................................. Municipal operators of community and non- 924110
transient non-community water systems required
to monitor.
----------------------------------------------------------------------------------------------------------------
\1\ North American Industry Classification System.
This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. This table lists the types of entities that EPA is now aware
could potentially be affected by this action. Other types of entities
not listed in the table could also be impacted. To determine whether
your facility is affected by this action, you should carefully examine
the applicability language at 40 CFR 141.2 (definition of public water
system). If you have questions regarding the applicability of this
action to a particular entity, consult the person listed in the
preceding FOR FURTHER INFORMATION CONTACT section.
B. How Can I Get Copies of This Document and Other Related Information?
1. Docket. EPA has established a docket for this action under
Docket ID No. EPA-HQ-OW-2006-0958. Publicly available docket materials
are available either electronically through https://www.regulations.gov
or in hard copy at the Water Docket in the EPA Docket Center, (EPA/DC)
EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC.
Copyrighted materials are available only in hard copy. The EPA Docket
Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is (202) 566-1744, and the telephone number for the
Water Docket is (202) 566-2426.
2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the Federal Register
listings at https://www.epa.gov/fedrgstr/.
Abbreviations and Acronyms Used in This Action
APHA: American Public Health Association
ASDWA: Association of State Drinking Water Administrators
ATP: Alternate Test Procedure
AVICP-AES: Axially Viewed Inductively Coupled Plasma-Atomic Emission
Spectrometry
CFR: Code of Federal Regulations
EPA: Environmental Protection Agency
FEM: Forum on Environmental Measurements
GWR: Ground Water Rule
HPLC: High-Performance Liquid Chromatography
ITS: Industrial Test Systems, Inc.
LT2ESWTR: Long Term 2 Enhanced Surface Water Treatment Rule
NEMI: National Environmental Method Index
SDWA: Safe Drinking Water Act
VCSB: Voluntary Consensus Standard Body
Table of Contents
I. General Information
A. Does This Action Apply to Me?
B. How Can I Get Copies Of This Document and Other Related
Information?
II. Background
A. What Is the Purpose of This Action?
B. What is the Basis for This Action?
C. Solicited Comments
D. Additional Comments
III. Summary of Approvals
A. Methods from Voluntary Consensus Standard Bodies (VCSB)
B. Methods developed by EPA
C. Methods developed by Vendors
IV. Statutory and Executive Order Reviews
V. References
II. Background
A. What Is the Purpose of This Action?
In this action, EPA is approving 99 analytical methods for
determining contaminant concentrations in samples collected under SDWA.
Regulated parties who are required to sample and monitor may do so by
using either the testing methods already established in existing
regulations or the alternative testing methods being approved in this
action. The new methods are listed in Appendix A to Subpart C in 40 CFR
141 and on EPA's drinking water methods Web site at https://www.epa.gov/
safewater/methods/expedited.html. A hard copy of the list of methods is
also available by calling the Safe Drinking Water Hotline at (800) 426-
4791.
B. What Is the Basis for This Action?
When EPA determines that an alternative analytical method is
``equally effective'' (i.e., as effective as a method that has already
been promulgated in the regulations), SDWA allows EPA to approve the
use of the alternative method through publication in the Federal
Register. See section 1401(1) of SDWA. EPA is using this streamlined
approval authority today to make 99 additional methods available for
determining contaminant concentrations in samples collected under SDWA.
EPA has determined that, for each contaminant or group of contaminants
listed below, the additional testing methods being approved in this
action are equally as effective as one or more of the testing methods
already established in the regulations for those contaminants. Section
1401(1) states that the newly approved methods ``shall be treated as an
alternative for public water systems to the quality control and testing
procedures listed in the regulation.'' Accordingly, this action makes
these additional (and optional) 99 analytical methods legally available
for meeting monitoring requirements.
This action does not add regulatory language, but does, for
informational purposes, add an appendix to the regulations at 40 CFR
part 141 that lists the newly approved methods. Accordingly, while this
action is not a rule, it is adding CFR text and therefore is being
published in the ``Final Rules'' section of this Federal Register.
EPA described this expedited methods approval process in an April
10, 2007, Federal Register notice (72 FR 17902) (USEPA 2007a) and
announced its intent to begin using the process. EPA also solicited
public comments on some of the implementation aspects of the process.
EPA received comments from seven States, two water systems, the
Association of Public Health Laboratories, the Association of State
Drinking Water Administrators (ASDWA), American Water Works
Association, a commercial vendor, a manufacturing company, and an
anonymous person. The comments were very supportive of the new approval
process. A summary of the most significant public comments is
[[Page 31618]]
presented in Section II.C and D. The public docket for this action
includes the Agency's complete response to comments (USEPA, 2008).
C. Solicited Comments
1. Location of the comprehensive list of methods approved under the
expedited process. In the April 10, 2007, Federal Register notice (72
FR 17902) (USEPA 2007a), EPA suggested three potential places for
listing all of the alternative methods that EPA has approved using this
expedited process. Public comments supported the use of all three
approaches (i.e., publishing as an appendix in the Code of Federal
Regulations (CFR), posting on the EPA Web site, and making available
from a designated Agency contact). The National Environmental Method
Index (NEMI) was mentioned as an additional mechanism for making the
list available.
EPA is providing the list in all of the suggested locations. First,
this action adds Appendix A to Subpart C of Part 141 (titled
``Alternative Testing Methods Approved for Analyses Under the Safe
Drinking Water Act'') to the CFR. The appendix provides the States with
a reference they can cite in their regulations, as was requested by
ASDWA and others. EPA intends to update the appendix each time
additional methods are approved using the expedited process.
The EPA drinking water methods Web site contains a new page that
focuses on the expedited methods approval process https://www.epa.gov/
safewater/methods/expedited.html. The page contains a link that allows
users to download a copy of the list of methods approved using this
process. The revision date and reference to the CFR citation are
included on the list. Hard copies of the list are also available from
the Safe Drinking Water Hotline.
EPA will continue to provide the managers of NEMI with the
information needed to incorporate newly approved methods into the NEMI
database. EPA methods are available for download from the NEMI Web site
(https://www.nemi.gov) and information is provided on the sources of any
methods that must be purchased.
2. Type of information included with expedited approval decisions
published in the Federal Register. Almost everyone who commented
requested that EPA provide information beyond a listing of methods and
the regulations to which the methods apply. A summary of the method,
the method citation, and the source for obtaining the method were of
greatest interest. EPA is including the method citation and source in
the footnote section of the table that lists methods approved under the
expedited process. This format ensures that the information is always
available with the list. EPA plans to provide a summary of each new
method as part of the discussion in the Federal Register that approves
the method, unless the method is an updated version of a previously
approved method (e.g., published in an earlier edition of Standard
Methods for the Analysis of Water and Wastewater). In the latter case,
the original method will have already been described. The approvals are
effective on the date of publication in the Federal Register.
EPA intends to provide additional information concerning the method
approval as part of the supporting material in the docket for each
action that approves additional, alternative methods using the
expedited process. A copy of each method being approved will be
included in the docket for the action. Additional information will
generally include:
The Alternative Test Procedures (ATP) summary report for
methods evaluated under the ATP process;
EPA method development report for EPA methods (summary of
experiments conducted during method development);
A description of changes to the original method for
modified methods; and
Rationale for approval including:
Summary of the performance characteristics that relate to
approval;
Detection limits and/or minimum reporting levels (MRLs)
when they are a regulatory requirement; and
Benefits provided by the new method.
In some cases, EPA may have already promulgated more than one
analytical method for a particular contaminant. In considering a new
method for approval, EPA may find that the new method has performance
characteristics that fall within the range of more than one of the
existing promulgated methods. In those cases, EPA may approve the new
method under the expedited process by comparing its effectiveness to
the group of existing promulgated methods rather than by reference to a
single existing method.
3. Amending regulatory text to describe where the list of methods
approved using the expedited process is found. Most commenters
indicated it would be helpful if the methods tables in the regulations
include a reference to the list of additional, alternative methods
approved under the expedited process. The commenters provided mixed
reactions to adding the same information at 40 CFR 141.27. EPA is
considering adding the requested references to the CFR text as part of
a future regulatory action.
Some commenters wanted EPA to publish a comprehensive list of all
approved drinking water methods. A few suggested that EPA incorporate
the alternative methods approved under the expedited method approval
process into the regulations when the methods tables are updated.
EPA understands the desire to have all methods listed together. As
a result, EPA is revising the drinking water methods Web site (https://
www.epa.gov/safewater/methods/methods.html) to address this request.
The user will be able to download comprehensive lists organized by
regulation/monitoring requirement (e.g., Ground Water Rule, Unregulated
Contaminant Monitoring Rule, Organic Contaminant Monitoring, etc.).
Each list will include the drinking water methods authorized in the
regulation and the alternative methods approved via the expedited
process. The revision date and CFR citations will be included on each
list. EPA believes that making the comprehensive lists available on the
Internet provides more timely access to the information in the
requested format than amending the methods tables in the regulations
would provide.
4. Format of the table that lists methods approved using the
expedited approval process. Most commenters indicated the table format
presented in the April 10, 2007, Federal Register notice (72 FR 17902)
(USEPA 2007a) is acceptable. One commenter suggested that the
contaminants be listed alphabetically in the first column of the table
in order to be consistent with the methods tables in the regulation,
while also providing a listing of all methods for a single contaminant
together. The commenter also requested that the table be completely
updated each time new approvals are made instead of appending new
approvals to the end of the table.
EPA is incorporating several of the suggestions into the final
table format. The table is organized by contaminant in order to improve
stakeholder access to the information. The table is divided into
sections so that the format mimics the methods tables in 40 CFR 141 and
143. In future expedited method approval actions, EPA will also
incorporate new methods into the table rather than appending them onto
the end in order to maintain the format.
Appendix A to Subpart C of Part 141 contains the same type of
information as was presented in the April 10, 2007, notice. Additional
information regarding the newly approved,
[[Page 31619]]
alternative methods is included in the Federal Register preamble and in
the docket as part of the background information concerning the
approvals.
In the future, if EPA withdraws approval for a method that was
approved via the expedited process, the Agency intends to update the
table at Appendix A to Subpart C of Part 141 to reflect both the
approval and withdrawal dates for the method in question.
5. State implementation of methods approved under the expedited
process. States' approaches to allowing use of methods approved under
the expedited process will vary. Some States will need to incorporate
the expedited process into their regulations while other States may
allow the use of the methods as soon as laboratories become certified
to use them. Some State certification programs are able to adopt
methods as soon as EPA approves them. This variability in
implementation approaches means some States will be able to adopt
methods approved under the expedited process more quickly than other
States. Although this variability was mentioned in the comments, this
situation is not unique to methods approved using the expedited
process; it is also a factor for methods approved via rulemaking.
One approach that EPA is using to assist States is to add an
appendix in the CFR that lists all alternative methods approved using
the expedited process. States can cite this appendix (Appendix A to
Subpart C in 40 CFR 141) when they update their regulations.
EPA is also making a copy of the appendix available on a Web page
https://www.epa.gov/safewater/methods/expedited.html. Some States may be
able to cite the URL as a source for alternative methods approved under
the expedited process.
Some States requested early access to information about methods
that are under consideration for approval in order to provide more time
to adopt EPA-approved methods. EPA will consider this request as it
implements the expedited process. Early sharing of information with
States would give them additional time to prepare for adopting new
analytical methods after they are published in the Federal Register.
State adoption of alternative methods approved under the expedited
process is optional. States may choose to allow only a more limited set
of methods to be used for compliance. States that choose to allow the
alternative methods approved through this expedited process will be
consistent with the requirement that States must have programs at least
as stringent as the Federal drinking water program in order to have
primary enforcement responsibility for the drinking water program.
When the regulation requires that the laboratory be certified to
perform analyses of samples for a specific contaminant, then this
requirement extends to the use of methods approved through the
expedited process. This means the States that choose to allow these
alternative methods will need to develop certification criteria, train
auditors, and evaluate laboratory capabilities for using the newly
approved methods. EPA expects that State certification programs will
incorporate methods approved using the expedited process into their
programs in the same manner as methods that are approved using
rulemaking. If the method is an updated version or a slight
modification of a previously approved method, then an abbreviated
certification process may be applicable.
The approval of methods, whether under rulemaking or the expedited
approach, presents similar challenges to the Agency and the States. The
approval decisions must be conveyed to the appropriate persons within
the States. EPA plans to disseminate information concerning future
method approvals using several approaches. A copy of the Federal
Register action will be sent to the State drinking water certification
and program offices. The Safe Drinking Water Hotline will have
information concerning the approvals and information will be posted on
EPA's drinking water methods Web page.
Withdrawal of method approval is a rare event under the regulatory
process and EPA expects its occurrence under the expedited process will
also be very limited. Methods will generally be withdrawn using the
same process as was used for their approval. Methods approved via the
expedited process will generally be withdrawn using the expedited
process; methods approved under rulemaking will be withdrawn using
rulemaking. Soliciting public comment through a rule proposal and
issuing a final rule after taking those comments into consideration
provides the States with time to withdraw the methods from their
programs. In order to provide a comparable timeframe under the
expedited process, EPA plans to consult with the States prior to
establishing effective dates for withdrawal of methods under the
expedited process. It is important that the effective date provide time
for the States to implement withdrawal, so that States will not be in a
position of allowing methods that were disapproved by EPA. The appendix
in the CFR will reflect both the approval and withdrawal dates for any
method that is withdrawn using the expedited process. Citing both dates
will eliminate any confusion as to when/whether a method approval is in
effect.
D. Additional Comments
The April 10, 2007, Federal Register notice solicited comments on
the process used by EPA to announce the approval of alternative methods
to the methods listed in regulation. EPA also received comments that
are indirectly related to the expedited method approval process. Brief
discussions of the major topics are presented below. All of the
comments and the Agency's response to comments (USEPA 2008) are
available in the docket for this action.
1. EPA evaluation process. The expedited approval process allows
EPA to approve methods more quickly and commenters support more timely
approval of methods. However, shortening the approval process raised
the question about whether EPA is changing the way that it evaluates
methods prior to issuing approval decisions. Some commenters asked that
EPA maintain its high standards for evaluating methods. Other
commenters provided recommendations for changing the review process in
order to both streamline and strengthen it.
The evaluation process is separate from the expedited approval
process. EPA is open to improving our evaluation process and to making
the process as transparent as possible. EPA appreciates the suggestions
and will consider them with any future evaluation of potential
improvements to the ATP program. EPA notes that some of the requested
changes are already included in our current evaluation protocol. For
example, minor modifications to existing methods generally do not
require extensive data submissions in order to demonstrate acceptable
method performance.
2. Prioritization of method evaluations. EPA recognizes that the
ability to approve methods more quickly may result in an increase in
the number of methods that are submitted to EPA for evaluation. It was
suggested that EPA prioritize method reviews so that methods that
provide the greatest benefit are evaluated first. EPA agrees with this
approach and intends to give new methods that provide significant
advantages over currently approved methods higher priority in the
review process. Improvements may be in areas such as waste
minimization, reduced analysis time, cost reduction, increased
[[Page 31620]]
method flexibility, introduction of an innovative technology, etc.
Implementation of this approach means that new methods will not
necessarily be reviewed/approved in the order in which they are
submitted to the Agency.
3. Public comment as part of the method approval process. EPA
understands the desire for the public to have an opportunity to comment
on methods approved under the expedited approval process. However,
introducing a comment period on these alternative methods is not
consistent with the expedited process intended by Congress; as a
result, EPA does not generally plan to solicit comment on these
alternative method approval decisions.
The purpose of this alternative procedure is to identify and allow
the use of methods that are equally as effective as methods already
approved in prior regulations. As a result, the benchmark for these
alternatives has already been provided through notice-and-comment
rulemaking on the original method(s). In addition, this expedited
approval process simply provides a broader set of compliance
opportunities for water systems. Finally, EPA expects to use the
expedited process only for those alternative methods that are clearly
equally effective relative to methods already approved through
regulation and that have performance that has been fully evaluated and
well documented, as discussed below.
EPA methods undergo peer review prior to publication. The
experimental results obtained during method development are usually
summarized in a report that is included in the docket when the method
is approved. The EPA method development research is often published in
a peer reviewed journal. In addition, new chemical and radiochemical
methods developed by EPA are evaluated according to Agency guidance
adopted by the EPA Forum on Environmental Measurements (FEM). (USEPA
2005, 2006a) The method validation principles are based on current,
international approaches and guidelines for intralaboratory (single
laboratory) and interlaboratory (multiple laboratory) method validation
studies. The Agency is developing similar guidance for validation of
microbiological methods and that guidance will be adopted when it
becomes available.
EPA plans to extend the use of the FEM guidance to methods that are
reviewed under the ATP program. EPA encourages method developers to
consult with the ATP coordinator during the development of their ATP
study plans so that the experimental designs incorporate the
appropriate tests. EPA intends to work with method developers during
this consultation process to be sure that their ATP study plans address
the principles outlined in the validation guidance. In addition, EPA
plans to solicit external scientific review for ATP methods that
involve new technology. The docket will contain the ATP study summary
report and the external scientific review comments in order to document
the basis for EPA's approval decision. If the method developer submits
confidential business information as part of the ATP review process,
the information will not be included in the docket.
Generally-accepted validation principles are usually followed for
methods that are developed by Voluntary Consensus Standard Bodies
(VCSBs), such as Standard Methods and ASTM, International. When a new
method is adopted by a VCSB, EPA reviews the data generated during
development and validation to verify the method is suitable for
analyzing drinking water samples. EPA plans to use the expedited method
approval process for methods that perform as well as the regulatory
methods. The supporting data that EPA uses to make the approval
determination will be placed in the docket so that the information is
publically available.
In unique cases in which EPA believes public comment is warranted
prior to approval, EPA may solicit comment through a notice and then
issue its decision on approving the alternative method after taking the
comments into consideration.
4. Methods recommended for approval. In the April 10, 2007, Federal
Register notice (72 FR 17902) (USEPA 2007a), EPA included two examples
of methods that were being considered for approval using the expedited
approval process. Commenters supported the approval of these methods
(i.e., EPA Method 200.5 and Standard Method 6610-04). They also
recommended additional methods for consideration.
EPA has enough information to make approval determinations for many
of the methods that were listed in the public comments. In those cases,
EPA is approving them as part of this action. Additional approval
decisions are pending submission of data that will allow EPA to further
compare the new methods' performance to that obtained by the regulatory
methods.
III. Summary of Approvals
EPA is approving 99 methods, 85 of which are identical to
previously approved methods from earlier publications and 14 of which
represent new or modified methods. EPA notes that the approval for all
of these methods, including the 85 ``identical'' methods previously
required a notice-and-comment rulemaking action.
A. Methods From Voluntary Consensus Standard Bodies (VCSB)
1. Standard Methods. EPA approved 73 methods in ``Standard Methods
Online'' as part of a ``Methods Update Rule'' issued on March 12, 2007
(72 FR 11200) (USEPA 2007b). Identical versions of these methods are
also published in the 21st edition of Standard Methods for the Analysis
of Water and Wastewater (Walker and Wendelken 2007). EPA recognizes
that some States and laboratories prefer the hardcopy version to the
electronic version that was previously approved. Since the 21st edition
versions of these methods are equally effective relative to the online
versions, EPA is approving the 73 methods from the 21st edition in this
action. The 21st edition (APHA 2006) can be purchased from American
Public Health Association (APHA), 800 I Street, NW., Washington, DC
20001-3710.
Six methods were published in ``Standard Methods Online'' too late
to be included in the March 12, 2007, Methods Update Rule. These
methods are also included in the 21st edition of Standard Methods for
the Analysis of Water and Wastewater (APHA 2006). Four of the methods
are unchanged and the other two updated methods reflect minor editorial
changes to the versions published in the 20th edition of Standard
Methods which are approved at 40 CFR 141.23 and 143.4 (Fair 2008a). EPA
is approving the following methods because they are equally effective
relative to the currently approved versions:
----------------------------------------------------------------------------------------------------------------
SM (21st ed) (APHA 2006) Standard methods online Contaminant Regulation
----------------------------------------------------------------------------------------------------------------
4500-P E........................... 4500-P E-99 (APHA 1999).... Orthophosphate........ 40 CFR 141.23(k)(1).
4500-P F........................... 4500-P F-99 (APHA 1999).... Orthophosphate........ 40 CFR 141.23(k)(1).
[[Page 31621]]
4500-SO4-\2\ C..................... 4500-SO4-\2\ C-97 (APHA Sulfate............... 40 CFR 143.4(b).
1997a).
4500-SO4-\2\ D..................... 4500-SO4-\2\ D-97 (APHA Sulfate............... 40 CFR 143.4(b).
1997a).
4500-SO4-\2\ E..................... 4500-SO4-\2\ E-97 (APHA Sulfate............... 40 CFR 143.4(b).
1997a).
4500-SO4-\2\ F..................... 4500-SO4-2 F-97 (APHA Sulfate............... 40 CFR 143.4(b).
1997a).
----------------------------------------------------------------------------------------------------------------
The 21st edition can be obtained from APHA, 800 I Street, NW.,
Washington, DC 20001-3710 and the Online methods can be purchased at
https://www.standardmethods.org.
The November 8, 2006, Ground Water Rule (GWR) (71 FR 65653) (USEPA
2006b) approved Colilert and Colisure media (Standard Method 9223 B,
20th Edition) for determining the presence of E. coli. Those two E.
coli media, along with a third medium, Colilert-18 (all part of SM
9223B), were listed in Table IV-1 of the preamble as being approved in
the rule. However, due to a publication oversight, the Colilert-18
methodology was omitted in the table at 40 CFR 141.402(c)(2). EPA is
using this expedited approval action to correct the inconsistency
between the preamble and rule language and clarify the status of
Colilert-18 as an approved methodology. Colilert-18, as described in
Standard Method 9223 B and published in the 20th edition of Standard
Methods for the Analysis of Water and Wastewater (APHA 1998), is
equally as effective as the previously promulgated Colilert and
Colisure media in Standard Method 9223 B (page 65593 of the GWR
preamble, USEPA 2006c) and is therefore approved in this action.
Accordingly, EPA is adding the Colilert-18 methodology to the list of
approved methods in Appendix A to Subpart C of Part 141.
Identical versions of Standard Method 9223 B are published in the
20th and 21st editions of Standard Methods for the Analysis of Water
and Wastewater and in ``Standard Methods Online'' (Fair 2008a). Because
the methods from all three sources are equally effective, EPA is
approving the 21st edition and the 1997 online version of Method 9223 B
for the Colilert, Colisure, and Colilert-18 methodologies. These newer
versions are equally effective relative to the methods cited at 40 CFR
141.402(c)(2). The 21st edition of Standard Methods (APHA 2006) can be
obtained from APHA, 800 I Street, NW., Washington, DC 20001-3710 and
Standard Method 9223 B-97 (APHA 1997b) can be purchased at https://
www.standardmethods.org.
EPA approved Standard Method 9230 B in the 20th edition of Standard
Methods for the Analysis of Water and Wastewater as one of the methods
for determining Enterococci under the GWR (71 FR 65653) (USEPA 2006b).
The online version of this method (9230 B-04) is identical to the
version published in the 20th edition (Fair 2008a). EPA is approving
Standard Method 9230 B-04 (APHA 2004b) for Enterococci detection,
because it is equally effective relative to the methods cited at
141.402(c)(2). The online method can be purchased at https://
www.standardmethods.org.
The January 5, 2006, Long Term 2 Enhanced Surface Water Treatment
Rule (LT2ESWTR) (71 FR 654) (USEPA 2006c) established source water
monitoring requirements for E. coli. It approved the same methods for
E. coli that are approved for ambient water monitoring under 40 CFR
136.3. The preamble in the LT2ESWTR proposal (68 FR 47640, August 11,
2003) (USEPA 2003a) listed the E. coli methods in the same format as
they were presented in the proposed Guidelines Establishing Test
Procedures for the Analysis of Pollutants; Analytical Methods for
Biological Pollutants in Ambient Water (66 FR 45811, August 30, 2001)
(USEPA 2001a). Two membrane filter methods (Standard Methods 9222 B and
9222 D) used in conjunction with Standard Method 9222 G to enumerate E.
coli were listed in both proposals. When the final Guidelines
Establishing Test Procedures for the Analysis of Pollutants; Analytical
Methods for Biological Pollutants in Ambient Water (68 FR 43272, July
21, 2003) (USEPA 2003b) was published, the methods table at 40 CFR
136.3 was published in a different format from the proposal. Standard
Method 9222 D/9222 G was listed as two step membrane filtration in the
table of approved methods and footnote 19 in the table indicated other
membrane filter procedures could be used prior to Standard Method 9222
G. Since Standard Method 9222 D is not explicitly listed in the final
rule, there is some confusion as to whether Standard Method 9222 D is
acceptable for the membrane filtration step. The July 21, 2003,
preamble (USEPA 2003b) stated that the final rule was promulgating the
test methods described in the proposed rule, and there was no reason
presented to exclude Standard Method 9222 D published in the 20th
edition of Standard Methods for the Analysis of Water and Wastewater
(APHA 1998) as an approved method. Therefore, EPA is using this
expedited method approval process to clarify that Standard Method 9222
D in combination with 9222 G is approved for enumerating E. coli under
the LT2ESWTR. Standard Method 9222 D/9222 G is equally as effective as
other promulgated methods for enumerating E. coli (USEPA 2001a).
Accordingly, EPA is adding Standard Method 9222 D/9222 G published in
the 20th edition of Standard Methods for the Analysis of Water and
Wastewater (APHA 1998) to the list of approved methods in Appendix A to
Subpart C of Part 141.
The April 10, 2007, Federal Register notice (72 FR 17902) (USEPA
2007a) listed Standard Method 6610-04 (APHA 2004a) as a potential
candidate for approval under the expedited approval process. This new
Standard Method uses high-performance liquid chromatography (HPLC) with
post-column derivatization and fluorescence detection to determine
carbamate pesticide concentrations in drinking water. After the
addition of a surrogate compound and filtration, water samples are
injected directly onto an HPLC and separated by use of a gradient and a
C18 column. The 11 carbamate pesticides that are analyzed by this
method are generally classified as phenyl and oxime carbamates and have
an N-methyl group in common. After chromatographic separation, the
compounds are hydrolyzed with 0.05N sodium hydroxide at 80 to 95
[deg]C, yielding a methyl amine which is then reacted with o-
phthalaldehyde and 2-mercaptoethanol to form a highly fluorescent
isoindole that is detected instrumentally. The method is applicable to
carbofuran and oxamyl, which are regulated in drinking water. The
method uses the same chemistry and quality control criteria as EPA
Method 531.2 (USEPA 2001b), which is approved for analyzing compliance
samples for carbofuran and oxamyl (40 CFR 141.24(e)(1)). EPA is
approving Standard Method 6610-04 (APHA 2004a) for the analysis of
compliance samples for carbofuran and oxamyl, because it is equally
effective relative to EPA Method 531.2 (Fair 2008a). EPA is also
approving the identical version of Standard Method 6610 that is
published
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in the 21st edition of Standard Methods for the Analysis of Water and
Wastewater (APHA 2006). EPA recognizes that this method may be used to
determine concentrations of additional compounds for which there are no
Federal monitoring requirements.
2. ASTM International. EPA compared new versions of six ASTM
methods to the most recent versions of those methods cited in 40 CFR
141 and 143. The new versions included changes such as:
More detailed quality control sections (D 512-04 B and D
1179-04 B);
Additional choices in equipment or reagents (D 859-05, D
1179-04 B, and D 2036-06 A and B);
More stringent reagent water specifications (D 512-04 B
and D 859-05);
Additional instructions for handling interferences (D
2036-06 A and B);
Modifications to allow analysis of additional types of
samples (D 5673-05); and
Editorial changes in all methods (changes in references,
reorganization, corrections of errors).
Data generated using the new methods are comparable to data
obtained using the previous versions because the chemistry and sample-
handling protocols are unchanged. The new versions are equally
effective relative to the version cited in regulation. (Fair, 2008a)
Thus, EPA is approving the use of these six ASTM methods:
----------------------------------------------------------------------------------------------------------------
ASTM method Contaminant Regulation
----------------------------------------------------------------------------------------------------------------
D512-04 B (ASTM International 2004a)... Chloride.................. 40 CFR 143.4(b).
D859-05 (ASTM International 2005a)..... Silica.................... 40 CFR 141.23(k)(1).
D1179-04 B (ASTM International 2004b).. Fluoride.................. 40 CFR 141.23(k)(1).
D2036-06 A (ASTM International 2006)... Cyanide................... 40 CFR 141.23(k)(1).
D2036-06 B (ASTM International 2006)... Cyanide................... 40 CFR 141.23(k)(1).
D5673-05 (ASTM International 2005b).... Uranium................... 40 CFR 141.25(a).
----------------------------------------------------------------------------------------------------------------
The ASTM methods are available from ASTM International, 100 Barr Harbor
Drive, West Conshohocken, PA 19428-2959 or https://www.astm.org.
B. Methods Developed by EPA
1. EPA Method 200.5, Revision 4.2. EPA described this method as a
candidate for approval under the expedited approval program in the
April 10, 2007, Federal Register notice (72 FR 17902) (USEPA 2007a).
Commenters were universally supportive of method approval.
EPA Method 200.5 (USEPA 2003c) uses axially viewed inductively
coupled plasma-atomic emission spectrometry (AVICP-AES) to determine
concentrations of 22 trace elements and contaminants in drinking water.
The method involves the following steps:
Sample digestion;
Volume reduction to provide a 2X concentration; and
Multi-elemental determinations by axially viewed
inductively coupled plasma-atomic emission spectrometry (AVICP-AES)
using sequential or simultaneous instruments. The instruments measure
characteristic atomic-line emission spectra by optical spectrometry.
Approved methods for 19 of the EPA Method 200.5 analytes are listed
at 40 CFR 141.23(k)(1) and 40 CFR 143.4. The performance
characteristics of EPA Method 200.5, Revision 4.2 were compared to the
characteristics of the methods listed at 40 CFR 141.23(k)(1) for
antimony, arsenic, barium, beryllium, cadmium, calcium, chromium,
copper, lead, magnesium, nickel, selenium, silica, and sodium. The
performance characteristics of EPA Method 200.5, Revision 4.2 were
compared to the characteristics of the methods listed at 40 CFR 143.4
for aluminum, iron, manganese, silver, and zinc (Fair 2008b). Since EPA
Method 200.5 is equally effective relative to the methods already
promulgated in the regulations, EPA is approving it for determining
aluminum, antimony, arsenic, barium, beryllium, cadmium, calcium,
chromium, copper, iron, lead, magnesium, manganese, nickel, selenium,
silica, silver, sodium, and zinc concentrations in drinking water to
comply with 40 CFR 141.23 and 143.4.
EPA Method 200.5, Revision 4.2 (USEPA 2003c) can be accessed and
downloaded directly on-line at https://www.epa.gov/nerlcwww/ordmeth.htm.
C. Methods Developed by Vendors
1. Method D99-003, Revision 3.0. If approved by the State, 40 CFR
141.74(a)(2) allows the use of DPD colorimetric test kits to determine
disinfectant residuals. Evaluation of the free chlorine test strip
method, Method D99-003 (Industrial Test Systems, Inc. 2003), under the
ATP program demonstrated performance characteristics similar to those
obtained using DPD colorimetric test kits. As a result, the March 12,
2007, Methods Update Rule (72 FR 11200) (USEPA 2007b) added language at
40 CFR 141.74(a)(2) to allow the use of Method D99-003 developed by
Industrial Test Systems, Inc. (ITS) to determine free chlorine
residuals in drinking water, if approved by the State. This approval
was specified for systems monitoring under the requirements of 40 CFR
141 Subpart H.
In a similar manner, 40 CFR 141.131(c)(2) allows the State to
approve the use of DPD colorimetric test kits for monitoring
requirements specified at 40 CFR 141.132(c)(1). The free chlorine test
strip method is not listed. As noted, however, evaluation of the
chlorine test strip method has demonstrated performance characteristics
similar to those obtained using DPD colorimetric test kits.
Accordingly, the chlorine test strip method is an equally effective
methodology, and there is no technical reason to withhold approval
under one rule while allowing its use under a separate regulation.
Therefore, EPA is using this action to approve the use of Method D99-
003 (ITS 2003) to meet free chlorine residual monitoring requirements
specified at 40 CFR 141.132(c)(1), if approved by the State.
Method D99-003, Revision 3.0, titled ``Free Chlorine Species
(HOCl- and OCl-) by Test Strip,'' November 21,
2003, is available from Industrial Test Systems, Inc., 1875 Langston
St., Rock Hill, SC 29730. The ATP report on this method is contained in
the docket for the March 12, 2007, Methods Update Rule.
IV. Statutory and Executive Order Reviews
As noted above, under the terms of SDWA Section 1401(1), this
streamlined method approval action is not a rule. Accordingly, the
Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement Fairness Act of 1996, does not apply
because this action is not a rule for purposes of 5 U.S.C. 804(3).
Similarly, this action is not subject to the Regulatory Flexibility Act
because it is not subject to notice and comment
[[Page 31623]]
requirements under the Administrative Procedure Act or any other
statute. In addition, because this approval action is not a rule but
simply makes alternative (optional) testing methods available for
monitoring under SDWA, EPA has concluded that other statutes and
executive orders generally applicable to rulemaking do not apply to
this approved action.
V. References
APHA. 1997a. Standard Method 4500-SO4-\2\-
97. Sulfate. Approved by Standard Methods Committee 1997. Standard
Methods Online. (Available at https://www.standardmethods.org.).
APHA. 1997b. Standard Method 9223 B-97. Enzyme Substrate
Coliform Test. Approved by Standard Methods Committee 1997. Standard
Methods Online. (Available at https://www.standardmethods.org.).
APHA. 1998. Twentieth Edition of Standard Methods for the
Examination of Water and Wastewater, American Public Health
Association, 800 I Street, NW, Washington, DC 20001-3710.
APHA. 1999. Standard Method 4500-P-99. Phosphorus. Approved by
Standard Methods Committee 1999. Standard Methods Online. (Available
at https://www.standardmethods.org.)
APHA. 2004a. Standard Method 6610-04. Carbamate Pesticides--
High-Performance Liquid Chromatographic Method. Approved by Standard
Methods Committee 2004. Standard Methods Online. (Available at
https://www.standardmethods.org.)
APHA. 2004b. Standard Method 9230 B-04. Fecal Enterococcus/
Streptococcus Groups--Multiple-Tube Technique. Approved by Standard
Methods Committee 2004. Standard Methods Online. (Available at
https://www.standardmethods.org.)
APHA. 2006. Twenty-first Edition of Standard Methods for the
Examination of Water and Wastewater, American Public Health
Association, 800 I Street, NW., Washington, DC 20001-3710.
ASTM International. 2004a. Method D 512-04 B. Standard Test
Method for Chloride Ion in Water by Silver Nitrate Titration. ASTM
International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-
2959. (https://www.astm.org)
ASTM International. 2004b. Method D 1179-04B. Standard Test
Method for Fluoride Ion in Water by Ion Selective Electrode. ASTM
International, 100 Barr Harbor Drive, West Conshohocken, PA 19428-
2959. (https://www.astm.org)
ASTM International. 2005a. Method D 859-05. Standard Test Method
for Silica in Water. ASTM International, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. (https://www.astm.org)
ASTM International. 2005b. Method D 5673-05. Standard Test
Method for Elements in Water by Inductively Coupled Plasma-Mass
Spectrometry. ASTM International, 100 Barr Harbor Drive, West
Conshohocken, PA 19428-2959. (https://www.astm.org)
ASTM International. 2006. Method D 2036-06. Standard Test Method
for Cyanides in Water. ASTM International, 100 Barr Harbor Drive,
West Conshohocken, PA 19428-2959. (https://www.astm.org)
Fair, P., 2008a. Memo to the record describing basis for
approving methods from Standard Methods and ASTM International.
April 2008.
Fair, P., 2008b. Memo to the record describing basis for
approving EPA Method 200.5. April 2008.
Industrial Test Systems, Inc. 2003. Method D99-003. Free
Chlorine Species (HOCl\-\ and OCl\-\) by Test Strip, Revision 3.0,
November 21, 2003. Industrial Test Systems, Inc., 1875 Langston St.,
Rock Hill, SC 29730.
USEPA. 2001a. Guidelines Establishing Test Procedures for the
Analysis of Pollutants; Analytical Methods for Biological Pollutants
in Ambient Water; Proposed Rule. 66 FR 45811. August 30, 2001.
USEPA. 2001b. EPA Method 531.2. Measurement of N-
methylcarbamoyloximes and N-methylcarbamates in Water by Direct
Aqueous Injection HPLC with Postcolumn Derivatization. Revision 1.0.
EPA 815-B-01-002 (Available at https://www.epa.gov/safewater/methods/
sourcalt.html.)
USEPA. 2003a. National Primary Drinking Water Regulations: Long
Term 2 Enhanced Surface Water Treatment Rule; Proposed Rule. 68 FR
47640. August 11, 2003.
USEPA. 2003b. Guidelines Establishing Test Procedures for the
Analysis of Pollutants; Analytical Methods for Biological Pollutants
in Ambient Water; Final Rule. 68 FR 43272. July 21, 2003.
USEPA. 2003c. EPA Method 200.5. Determination of Trace Elements
in Drinking Water by Axially Viewed Inductively Coupled Plasma-
Atomic Emission Spectrometry. Revision 4.2. EPA/600/R-06/115.
(Available at https://www.epa.gov/nerlcwww/ordmeth.htm.)
USEPA. 2005. Validation and Peer Review of U.S. Environmental
Protection Agency Chemical Methods of Analysis, FEM Document Number
2005-01, October 2005.
USEPA. 2006a. Validation and Peer Review of U.S. Environmental
Protection Agency Radiochemical Methods of Analysis, FEM Document
Number 2006-01, August 2006.
USEPA. 2006b. National Primary Drinking Water Regulations:
Ground Water Rule. 71 FR 65574. November 8, 2006.
USEPA. 2006c. National Primary Drinking Water Regulations: Long
Term 2 Enhanced Surface Water Treatment Rule; Final Rule. 71 FR 654.
January 5, 2006.
USEPA. 2007a. Expedited Approval of Test Procedures for the
Analysis of Contaminants Under the Safe Drinking Water Act; Analysis
and Sampling Procedures. 72 FR 17902. April 10, 2007.
USEPA. 2007b. Guidelines Establishing Test Procedures for the
Analysis of Pollutants Under the Clean Water Act; National Primary
Drinking Water Regulations; and National Secondary Drinking Water
Regulations; Analysis and Sampling Procedures; Final Rule. 72 FR
11200. March 12, 2007.
USEPA. 2008. Response to Comments Document for Expedited
Approval of Test Procedures for the Analysis of Contaminants Under
the Safe Drinking Water Act; Analysis and Sampling Procedures (72 FR
17902. April 10, 2007). May 2008.
Walker, L. and Wendelken, S., 2007. Letter to S. Posavec,
Standard Methods Manager, April 11, 2007.
List of Subjects in 40 CFR Part 141
Environmental protection, Chemicals, Indians-lands,
Intergovernmental relations, Radiation protection, Reporting and
recordkeeping requirements, Water supply.
Dated: May 20, 2008.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
0
For the reasons stated in the preamble, 40 CFR part 141 is amended as
follows:
PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS
0
1. The authority citation for part 141 continues to read as follows:
Authority: 42 U.S.C. 300f, 300g-1, 300j-4, and 300j-9.
0
2. Subpart C is amended by adding Appendix A to read as follows:
Appendix A to Subpart C of Part 141--Alternative Testing Methods
Approved for Analyses Under the Safe Drinking Water Act.
Only the editions stated in the following table are approved.
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