[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Rules and Regulations]
[Pages 31616-31633]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12198]
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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.
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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:
[email protected].
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:
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Category Examples of potentially regulated entities NAICS \1\
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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.
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\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 http://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 http://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 http://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 http://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
(http://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 (http://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
http://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:
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SM (21st ed) (APHA 2006) Standard methods online Contaminant Regulation
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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).
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The 21st edition can be obtained from APHA, 800 I Street, NW.,
Washington, DC 20001-3710 and the Online methods can be purchased at
http://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 http://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 http://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 http://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 http://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 http://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 http://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 http://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
http://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
http://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. (http://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. (http://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. (http://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. (http://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. (http://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 http://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 http://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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