Expedited Approval of Test Procedures for the Analysis of Contaminants
Under the Safe Drinking Water Act; Analysis and Sampling Procedures
[Federal Register: April 10, 2007 (Volume 72, Number 68)]
[Notices]
[Page 17902-17907]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ap07-75]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OW-2006-0958; FRL-8297-2]
Expedited Approval of Test Procedures for the Analysis of Contaminants
Under the Safe Drinking Water Act; Analysis and Sampling Procedures
AGENCY: Environmental Protection Agency.
ACTION: Notice.
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SUMMARY: This action announces the Environmental Protection Agency's
(EPA's) intent to implement an expedited process for approving
alternative testing methods for existing regulations for drinking water
contaminants. The Safe Drinking Water Act (SDWA) authorizes EPA to
approve the use of alternative testing methods through publication of a
notice in the Federal Register instead of through rulemaking
procedures. EPA plans to use this streamlined authority to make
additional methods available for analyzing drinking water compliance
and unregulated contaminant monitoring samples. This expedited approach
will provide public water systems, laboratories, and primacy 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.
This notice requests comments on implementation aspects of the
expedited method approval process.
DATES: Comments must be received on or before June 11, 2007.
ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2006-0958, by one of the following methods:
? http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
? E-mail: OW-Docket@epa.gov.
? Fax: (202) 566-1749.
? Mail: Water Docket, Environmental Protection Agency,
Mailcode: 4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2006-
0958. All comments received will be included in the public docket
without change and may be made available online at http://www.regulations.gov,
including any personal information provided, unless the comment
includes information claimed to be Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Do not submit information that you consider to be CBI or otherwise
protected through http://www.regulations.gov or e-mail. The
http://www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through http://www.regulations.gov, your
e-mail address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm. For additional
instructions on submitting comments, go to Section I.B of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Water Docket, EPA/DC, EPA
West, Room 3334, 1301 Constitution Ave., NW., Washington DC. The 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.
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?
This action itself does not impose any requirements on anyone.
Instead, it notifies interested parties of EPA's intent to implement an
expedited approval process for alternative testing procedures used to
measure contaminants in drinking water and seeks comments on options
for implementing the process.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit confidential business information
to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or
all of the information that you claim to be CBI. For CBI information in
a disk or CD ROM that you mail to EPA, mark the outside of the disk or
CD ROM as CBI and then identify electronically within the disk or CD
ROM the specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for Preparing Your Comments. Your comments will be most
helpful if you remember to:
? Identify the action by docket number and other identifying
information (subject heading, Federal Register date and page number).
? Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
? Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
? Describe any assumptions and provide any technical
information and/or data that you used.
? If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
? Provide specific examples to illustrate your concerns, and
suggest alternatives.
[[Page 17903]]
? Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
3. Timing. You must submit your comments by the comment period
deadline identified above (see DATES).
Abbreviations and Acronyms Used in the Notice
ATP: Alternate Test Procedure
CFR: Code of Federal Regulations
EPA: Environmental Protection Agency
MCL: Maximum Contaminant Level
NPDWR: National Primary Drinking Water Regulations
NSDWR: National Secondary Drinking Water Regulations
SDWA: Safe Drinking Water Act
UCMR: Unregulated Contaminant Monitoring Regulations
U.S.C.: United States Code
VCSB: Voluntary Consensus Standard Body
Table of Contents
I. General Information
A. Does This Action Apply to Me?
B. What Should I Consider as I Prepare My Comments for EPA?
II. Background
A. What Is the Purpose of This Notice?
B. Statutory Background
C. How Does EPA Currently Approve Testing Methods for Drinking
Water Contaminants?
III. Expedited Method Approval
A. What Is Expedited Method Approval?
B. Why Is EPA Implementing the Expedited Method Approval Process?
C. Will EPA Use This Process to Approve All New Methods?
D. Will EPA Also Use the New Expedited Process To Approve
Alternative Methods for National Secondary Drinking Water
Regulations and Unregulated Contaminants?
E. Will EPA Use This Process To Withdraw Approval for Methods?
F. How Often Will Methods Be Approved Using the Expedited Process?
G. How Will I Know When a Method Is Approved Using the Expedited
Process?
H. Will There Be a Comprehensive List of All Methods Approved
Using the Expedited Process?
I. Will a Regulation Tell Me Where To Find the Comprehensive
List of Methods Approved Using the Expedited Process?
J. Will Regulatory Authorities Accept the Data Generated Using
Methods Approved by the Expedited Approach?
K. Where Can I Find Copies of the Methods Approved by This Process?
L. Must My Laboratory Be Certified to Use these Methods?
M. Are Any Particular Methods Currently Under Consideration for
Approval Using the Expedited Process?
IV. Request for Comment
V. References
II. Background
This section provides the purpose of this action, a brief statutory
background on approval of testing methods for drinking water
contaminants, and a description of how EPA currently approves drinking
water testing methods.
A. What Is the Purpose of This Notice?
This action explains the expedited process that EPA plans to
implement for the approval of testing methods for drinking water
contaminants and seeks comments on specific aspects of the process.
B. Statutory Background
Analytical methods are approved by EPA to support three types of
drinking water monitoring. Under the Safe Drinking Water Act (SDWA),
EPA promulgates national primary drinking water regulations (NPDWRs)
that specify maximum contaminant levels (MCLs) or treatment techniques
for drinking water contaminants (SDWA section 1412 (42 U.S.C. 300g-1)).
The NPDWRs apply to public water systems pursuant to SDWA section
1401(1)(A) (42 U.S.C. 300f(1)(A)). The NPDWRs include analytical
testing methods that are used to measure compliance. Per SDWA section
1401(1)(D), NPDWRs include ``* * * criteria and procedures to assure a
supply of drinking water which dependably complies with such maximum
contaminant levels; including accepted methods for quality control and
testing procedures * * *'' (42 U.S.C. 300f(1)(D)). In addition, SDWA
section 1445(a)(1) authorizes the Administrator to establish
regulations for monitoring to help determine whether persons are acting
in compliance with the requirements of SDWA (42 U.S.C. 300j-4). EPA's
promulgation of analytical methods for NPDWRs is authorized under these
sections of SDWA as well as the general rulemaking authority in SDWA
section 1450(a) (42 U.S.C. 300j-9(a)).
SDWA also authorizes EPA to promulgate national secondary drinking
water regulations (NSDWRs) for contaminants in drinking water that
primarily affect the aesthetic qualities relating to the public
acceptance of drinking water (SDWA section 1412 (42 U.S.C. 300g-1)).
These regulations are not Federally enforceable but are guidelines for
the States (40 CFR 143.1). The NSDWRs also include analytical
techniques for determining compliance with the regulations (40 CFR
143.4). EPA's promulgation of analytical methods for NSDWRs is
authorized under general rulemaking authority in SDWA section 1450(a)
(42 U.S.C. 300j-9(a)).
Section 1445(a)(2) of the Act gives EPA discretion in setting the
process for approving analytical methods for unregulated contaminant
monitoring. For consistency with the procedures for NPDWRs, EPA
includes analytical methods in the unregulated contaminant monitoring
regulations (UCMRs).
In the 1996 Amendments to SDWA, Section 1401(1) states the
following: ``At any time after promulgation of a regulation referred to
in this paragraph, the Administrator may add equally effective quality
control and testing procedures by guidance published in the Federal
Register. Such procedures shall be treated as an alternative for public
water systems to the quality control and testing procedures listed in
the regulation.'' By this action, EPA is stating that it plans to use
this authority to develop an expedited process for establishing
alternative testing methods for previously promulgated methods. Under
this approach, EPA will publish a notice in the Federal Register rather
than using a notice-and-comment rulemaking process to approve the use
of alternative testing methods for existing regulations.
C. How Does EPA Currently Approve Testing Methods for Drinking Water
Contaminants?
When EPA establishes a monitoring requirement for a drinking water
contaminant, the Agency also specifies at least one reference
analytical method that can be used to determine the contaminant's
concentration in drinking water. Public water systems must currently
use a testing method listed in the regulation when performing analyses
of samples to demonstrate compliance or for use in unregulated
contaminant monitoring.
Methods that are incorporated into the regulation are approved
through a rulemaking process. In general, this means that EPA publishes
a proposed rule, citing the method along with a discussion of how the
method can be used to analyze samples. The method is proposed for
approval in conjunction with monitoring requirements for one or more
specific contaminants. EPA solicits public comment. After consideration
of the comments, EPA decides whether to approve the method. If the
method is deemed suitable, it is included in a final rule. The method
is not approved for analysis of compliance or UCMR samples until it is
referenced in a final rule.
EPA examines the performance characteristics of methods prior to
proposing them in a regulation. In order for a method to be considered
for approval, EPA generally requires that it meet a number of criteria,
including the following:
[[Page 17904]]
? It must be applicable to routine analyses of samples.
? The method must be suitable for measuring the drinking
water contaminant in the concentration range of interest.
? The accuracy and precision of the method must be such that
data can be used to demonstrate compliance with the MCL or meet UCMR
monitoring objectives in a wide variety of drinking water matrices.
? The method should include instructions for all aspects of
the analysis from sample collection to data reporting.
? Appropriate quality control criteria should be
incorporated so that acceptable method performance is demonstrated
during the analysis of samples.
EPA attempts to approve multiple analytical methods for each
contaminant in order to provide public water systems with flexibility
in meeting their compliance or unregulated contaminant monitoring
requirements. EPA also incorporates as much flexibility as is practical
into reference methods that EPA develops itself. Subsequent to the
establishment of monitoring requirements, EPA continues to evaluate
additional analytical methods as they become available. New methods may
be submitted to EPA through the Alternate Test Procedure (ATP) program
or from Voluntary Consensus Standard Bodies (VCSBs) such as Standard
Methods or ASTM International. Additional methods may also be developed
by EPA or EPA may revise existing methods to incorporate improvements
in technology, minimize use of hazardous solvents, or reduce the cost
of the analysis. To date, when new or revised testing methods were
deemed suitable for analyzing compliance or UCMR samples, EPA approved
them through the rulemaking process (i.e., by soliciting public
comments through a rule proposal and issuing a final rule after taking
those comments into consideration). EPA periodically issues method
update rules in order to approve additional testing methods.
III. Expedited Method Approval
A. What Is Expedited Method Approval?
Section 1401(1)(D) of SDWA, as amended in 1996, authorizes EPA to
approve alternative testing methods outside the normal notice-and-
comment rulemaking process. To use this expedited process, EPA must
already have promulgated at least one analytical testing method for the
contaminant in question through the normal rulemaking process. Once EPA
has approved one testing method through the rulemaking process, section
1401(1)(D) allows EPA to approve additional (alternative) testing
methods for the same contaminant through an expedited process that
simply involves publishing the alternative method in the Federal
Register. To use this expedited process, EPA must first find that the
alternative testing method is ``equally effective'' as the method that
was approved through rulemaking.
EPA will examine the performance characteristics of each new method
being considered for approval using the expedited process in the same
manner as is currently used when promulgating a method by regulation.
The method will be evaluated on the basis of its selectivity, bias,
precision, quantitation range and detection characteristics. In
general, quality control procedures and criteria must be available to
provide an on-going demonstration of method performance during the
analysis of samples.
After a method is demonstrated to be suitable for analyzing
compliance or unregulated contaminant monitoring samples for a specific
contaminant, and EPA deems it to be ``equally effective'' as the
originally promulgated method, EPA will publish a notice in the Federal
Register to announce that determination. Because the rulemaking process
will not be used, the alternative method will not be cited in the
drinking water regulations (which are contained at 40 CFR Part 141).
Only the originally promulgated method will continue to be cited in
that manner. However, alternative methods approved using the expedited
process will be fully available to public water systems for compliance
or unregulated contaminant monitoring and reporting to the same extent
as the methods that were approved through the normal rulemaking process.
B. Why Is EPA Implementing the Expedited Method Approval Process?
EPA encourages the development of new measurement technologies and
the improvement of traditional analytical techniques. These advances
often result in benefits such as shorter analysis times, minimized use
of solvents, greater specificity in the analytical results, or more
robust analytical procedures that are less prone to quality control
failures. The benefits can lead to more cost effective monitoring.
The expedited method approval process will improve EPA's ability to
make new technologies and improved analytical techniques available in a
timely manner. Under the current process, after a method is shown to be
suitable for analyzing drinking water compliance or unregulated
contaminant monitoring samples, it cannot be used for that purpose
until the rulemaking process is completed. The traditional rulemaking
process in some cases can take two to three or more years to complete.
This means the method is not available for monitoring for several
years. Under the expedited process described in this notice, the method
will be available as soon as EPA publishes a Federal Register notice
announcing that the method can be used for analyzing drinking water
compliance or UCMR samples. EPA anticipates most alternative methods
will be approved in this manner within six to eight months after they
are determined to be applicable to the analysis of compliance or UCMR
samples.
C. Will EPA Use This Process To Approve All New Methods?
As stated above, EPA will use the expedited methods approval
process only to approve additional testing methods for contaminants for
which EPA has already promulgated regulations, including at least one
analytical method.
EPA anticipates that the expedited process will be the primary
mechanism used to approve additional testing methods. EPA expects to
use this process to approve new or revised methods from sources such as:
? VCSBs, such as Standard Methods or ASTM International;
? Vendors who have submitted new technologies or methods to
the ATP program; and
? EPA or other governmental organizations.
There may be instances in which EPA will seek public comment prior
to approving a new or revised method because additional information is
needed. In those cases, EPA will consider whether to still approve the
new or revised method through the expedited process described in this
notice or use the normal rulemaking process.
D. Will EPA Also Use the New Expedited Process To Approve Alternative
Methods for National Secondary Drinking Water Regulations and
Unregulated Contaminants?
Yes. In addition to using the expedited process with respect to
NPDWRs, EPA plans to use the expedited process to approve additional
test methods for national secondary drinking water regulations and
unregulated contaminants as well. In both cases, there will need to be
at least one test method that EPA has already
[[Page 17905]]
specified and promulgated by regulation, and EPA will approve the
alternative methods only upon finding that they are equally as
effective as the specified method.
National secondary drinking water regulations, which are contained
in 40 CFR Part 143, are not enforceable but are intended as guidelines
for States. Analytical methods are specified in these guidelines at 40
CFR 143.4. EPA will use the expedited process to add any alternative
methods that are equally as effective as the methods set forth in the
guidelines.
For unregulated contaminants, under the authority of Section
1445(a)(2) of SDWA, EPA promulgates regulations that specify monitoring
requirements, including analytical methods. See 40 CFR 141.40. Section
1445(a) gives EPA discretion in setting the process for approving
analytical methods for the unregulated contaminants. For consistency
with the procedures for NPDWRs, and given Congress's clear intent to
expedite the process for adding analytical methods as new methods
become available, EPA intends to use these expedited procedures to add
methods for the unregulated contaminants as well.
E. Will EPA Use This Process To Withdraw Approval for Methods?
Under certain conditions, it may be necessary for EPA to withdraw
approval of a testing method. For example, if an MCL is lowered to
better protect public health, a method that was suitable for
demonstrating compliance with the higher MCL may no longer have the
necessary sensitivity. There may also be instances in which an approved
method becomes obsolete because it uses hazardous reagents or fails to
meet the performance characteristics of other approved methods.
EPA will not use the expedited process described in this notice to
withdraw approval of any method that EPA originally approved through
the rulemaking process. In that case, EPA will again use the rulemaking
process to withdraw approval for such testing methods when necessary.
However, the new process will be used to withdraw approval of any
method that was initially approved using the expedited process. EPA
will withdraw approval of such a method by publishing a Federal
Register notice describing EPA's rationale for the withdrawal and
stipulating an effective date for the action.
F. How Often Will Methods Be Approved Using the Expedited Process?
EPA intends to use the expedited approval process in such a manner
that methods are approved as soon as possible after they are determined
to be suitable for analyzing drinking water compliance or UCMR samples.
The frequency will depend on the number of methods that are awaiting
approval and the urgency for that approval. For example, EPA may
approve a single method using this process if exercising the expedited
method could significantly benefit the public by reducing monitoring
costs while maintaining data quality. Currently, EPA expects that the
process will be implemented at least annually and that it will normally
involve approval of multiple methods.
G. How Will I Know When a Method Is Approved Using the Expedited Process?
EPA will publish a notice in the Federal Register to announce the
expedited method approvals. At a minimum, the notice will list the new
method(s) being approved, the contaminant(s) for which each method
approval is granted, a reference to the regulation that cites the
reference method(s) for each contaminant, and information concerning
where a copy of each method can be obtained.
EPA is also considering whether additional information should be
included in the Federal Register notice. When EPA proposes approval of
new methods using the regulatory process, the preamble to the proposed
rule usually contains a brief description of the method, a summary of
the method performance characteristics, and a discussion of the basis
for the approval(s). The information is presented to better inform the
reader so that public comment can be obtained. Under the expedited
process, EPA does not anticipate publishing this particular
information. However, EPA is using this Federal Register notice to
solicit comment on the type of information that would be useful to the
public and regulated entities when new methods are approved using the
expedited process.
H. Will There Be a Comprehensive List of All Methods Approved Using the
Expedited Process?
EPA plans to maintain a comprehensive list of methods approved
through the expedited process. The public availability of the list is
one of the subjects EPA is soliciting comment on in this notice. EPA
anticipates that State agencies, public water systems, and laboratories
will want access to a comprehensive list to simplify the tracking of
method approvals listed in multiple Federal Register notices.
EPA is requesting input on whether a comprehensive list should be
provided and if so, the mechanism for making it available. One option
would be to list the methods in the Code of Federal Regulations (CFR)
as an appendix to the drinking water regulations. A revised hard copy
edition of the CFR is printed once per year, but it is continually
updated electronically throughout the year and is available to the
public through the Internet at http://ecfr.gpoaccess.gov. So, while the
CFR hard copy would generally contain an up-to-date list of methods, it
would not show methods that have been added since the previous
published update.
A second option would be to list the methods on an EPA Web site.
EPA would update the Web page each time a new method is approved. Under
this option, the Federal Register notice would list the new method
approvals and refer the public to the Web site for a complete listing
of methods approved under the expedited process. The Web site could
either show the list or provide a link for downloading a fact sheet
with the list in an electronic format.
A third option would be to make the list available through the Safe
Drinking Water Hotline or through an Agency designated contact for
those who do not have Internet access.
A fourth option would combine some or all of the above approaches
by listing the methods in an appendix to the CFR, on the Internet, and/
or in a fact sheet available from the Agency.
I. Will a Regulation Tell Me Where To Find the Comprehensive List of
Methods Approved Using the Expedited Process?
The current regulations at 40 CFR Parts 141 and 143 do not contain
any information about where methods approved using the expedited
process would be listed. EPA does not plan to immediately change the
regulatory text when the expedited method approval process is
implemented. If it would be helpful to add a cross-referencing
statement in the NPDWRs, NSDWRs, and/or UCMRs, referring to a list of
the methods approved using the expedited process so that regulated
entities and the public could more easily find the information, EPA may
consider such a change to the regulations in future actions.
One option would be to add a paragraph at 40 CFR 141.27, since this
section deals with approval of alternate analytical techniques. The
paragraph
[[Page 17906]]
might state, ``The methods listed in (location of list, per Section
III.H, inserted here) may be used as alternatives to the methods listed
in the NPDWRs, NSDWRs, and UCMR.''
A second option would be to add a footnote to each table of
approved methods in the NPDWRs, NSDWRs and/or UCMR (i.e., 40 CFR
141.21(f)(3), 141.23(k)(1), 141.24(e), 141.25(a), 141.40, 141.74(a)(1),
141.131(b), (c), and (d) and 143.3(b)).
EPA is requesting comment on whether adding the location of the
comprehensive list to future regulatory text is warranted, and if so,
where that information should be added.
J. Will Regulatory Authorities Accept the Data Generated Using Methods
Approved by the Expedited Approach?
In States, territories, and tribes in which EPA has primacy (which
includes Wyoming, the District of Columbia, and all Indian lands except
the Navajo), when EPA approves an alternative analytical method through
the expedited process, a facility will generally be able to use either
that new method or the originally promulgated method to meet its
regulatory requirements for compliance or unregulated contaminant
monitoring and reporting (although there may be State or local
restrictions). Note that if a laboratory chooses to use a method approved
under the expedited process, it must adhere to the written procedures
described in the method and meet all the quality control criteria that
are specified, just as it would for a method approved via regulation.
Where the State, territory or tribe has primacy (which, for States
and territories, is in most cases), it is up to the State, territory,
or tribe to decide whether to allow the use of alternative analytical
methods that have been approved by EPA and, if allowed, the process for
adopting those new methods within its own program. Since these
decisions will vary from State to State, facilities will need to be
aware of their Primacy Agency's own requirements prior to using an
alternative method that EPA has approved under the expedited method
approval process. Primacy Agencies are invited to provide comment on
how methods approved under this new procedure will be implemented in
their programs and if there are concerns that EPA can address when
implementing this new approval process (in order to simplify or
expedite Primacy Agency acceptance of the alternative methods).
K. Where Can I Find Copies of the Methods Approved by This Process?
The Federal Register notice announcing the approval of methods
under the expedited process will include information concerning where
the complete methods can be obtained. This information will also be
included with the comprehensive list of methods approved under the
expedited process.
A docket will be created each time EPA announces approval of
methods under the expedited process and a copy of each method will be
placed in the docket. All documents in the docket will be listed in the
http://www.regulations.gov index. Publicly available docket materials,
excluding copyrighted materials, will be available electronically in
http://www.regulations.gov and in hard copy at the Water Docket.
Copyrighted materials will only be available in hard copy at the Water
Docket.
L. Must My Laboratory Be Certified to Use These Methods?
If the originally promulgated regulation requires that the
laboratory be certified to perform analyses of compliance samples for a
specific contaminant, then EPA plans to extend this requirement to use
of methods approved through the expedited process. Similarly, if a
``party approved by the State'' is specified in the regulation, then
EPA plans to extend this requirement to use of the alternative method.
M. Are Any Particular Methods Currently Under Consideration for
Approval Using the Expedited Process?
In an effort to assist the public in understanding the expedited
approval process, EPA is providing two examples of methods that are
being considered for approval using this process. Approval is not being
granted in this notice, but EPA anticipates approving them when the
process is ultimately implemented. They are included herein so that the
public can comment on the format of the listing and the type of
information presented on each method.
1. EPA Method 200.5, Revision 4.2. Determination of Trace Elements in
Drinking Water by Axially Viewed Inductively Coupled Plasma-Atomic
Emission Spectrometry (USEPA, 2003)
Axially viewed inductively coupled plasma-atomic emission
spectrometry can be used to determine concentrations of several trace
elements and water matrix elements in drinking water. 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 the
same contaminants. Based on this evaluation, EPA expects that it will
be able to deem this method to be equally effective as the promulgated
methods for determining antimony, arsenic, barium, beryllium, cadmium,
chromium, copper, lead, and selenium concentrations. Therefore, EPA
anticipates approving this method when the Expedited Approval Process
is implemented in a future Federal Register notice (but again, EPA is
not approving this method today).
EPA Method 200.5, Revision 4.2, can be accessed and downloaded
directly on-line at http://www.epa.gov/nerlcwww/ordmeth.htm.
2. Standard Method 6610-04. High-Performance Liquid Chromatographic
Method for Carbamate Pesticides (APHA, 2004)
High-performance liquid chromatography with post-column
derivatization and fluorescence detection can be used to determine the
concentrations of carbamate pesticides in drinking water. Standard
Method 6610-04 is based on EPA Method 531.2 (USEPA, 2001), which is
approved for analyzing compliance samples for carbofuran and oxamyl (40
CFR 141.24(e)(1)). Therefore, EPA expects that it will be able to deem
Standard Method 6610-04 to be equally effective as the promulgated
method for determining carbofuran and oxamyl concentrations in
compliance samples. Thus, EPA anticipates approving this method when
the Expedited Approval Process is implemented in a future Federal
Register notice (but again, EPA is not approving this method today).
Standard Method 6610 B-04 is available at
http://www.standardmethods.org. 
Alternative Analytical Methods Under Consideration for Approval Using the Expedited Approval Process
----------------------------------------------------------------------------------------------------------------
Alternate method (being Alternate Citation for methods approved by
considered for approval) methodology Contaminant regulation
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EPA Method 200.5, Revision 4.2 AVICP-AES \2\....... Antimony............ 40 CFR 141.23(k)(1)
\1\.
EPA Method 200.5, Revision 4.2... AVICP-AES........... Arsenic............. 40 CFR 141.23(k)(1)
[[Page 17907]]
EPA Method 200.5, Revision 4.2... AVICP-AES........... Barium.............. 40 CFR 141.23(k)(1)
EPA Method 200.5, Revision 4.2... AVICP-AES........... Beryllium........... 40 CFR 141.23(k)(1)
EPA Method 200.5, Revision 4.2... AVICP-AES........... Cadmium............. 40 CFR 141.23(k)(1)
EPA Method 200.5, Revision 4.2... AVICP-AES........... Calcium............. 40 CFR 141.23(k)(1)
EPA Method 200.5, Revision 4.2... AVICP-AES........... Chromium............ 40 CFR 141.23(k)(1)
EPA Method 200.5, Revision 4.2... AVICP-AES........... Copper.............. 40 CFR 141.23(k)(1)
EPA Method 200.5, Revision 4.2... AVICP-AES........... Lead................ 40 CFR 141.23(k)(1)
EPA Method 200.5, Revision 4.2... AVICP-AES........... Magnesium........... 40 CFR 141.23(k)(1)
EPA Method 200.5, Revision 4.2... AVICP-AES........... Selenium............ 40 CFR 141.23(k)(1)
EPA Method 200.5, Revision 4.2... AVICP-AES........... Silica.............. 40 CFR 141.23(k)(1)
EPA Method 200.5, Revision 4.2... AVICP-AES........... Sodium.............. 40 CFR 141.23(k)(1)
Standard Method 6610-04 \3\...... HPLC\4\............. Carbofuran.......... 40 CFR 141.23(k)(1)
Standard Method 6610-04.......... HPLC................ Oxamyl.............. 40 CFR 141.23(k)(1)
----------------------------------------------------------------------------------------------------------------
\1\ EPA Method 200.5, Revision 4.2, ``Determination of Trace Elements in Drinking Water by Axially Viewed
Inductively Coupled Plasma-Atomic Emission Spectrometry,'' USEPA, October 2003, EPA/600/R-06/115 can be
accessed and downloaded directly on-line at http://www.epa.gov/nerlcwww/ordmeth.htm.
\2\ Axially viewed inductively coupled plasma-atomic emission spectrometry (AVICP-AES).
\3\ Carbamate Pesticides--High-Performance Liquid Chromatographic Method. The Standard Method Online version
that is approved is indicated by the last two digits in the method number which is the year of approval by the
Standard Methods Committee. Standard Methods Online is available at http://www.standardmethods.org.
\4\ High-performance liquid chromatography (HPLC) in conjunction with a post-column derivatization system and a
fluorescence detector.
IV. Request for Comment
EPA seeks comments on several aspects in the implementation of the
expedited methods approval process. The information and comments
submitted in response to this notice will be considered in determining
the final details of the implementation process.
Specifically, EPA seeks comments on the following:
1. EPA requests comment on whether a comprehensive list of methods
approved under the expedited process should be publicly maintained. If
such a list is desirable, then how should EPA make it available?
? As an appendix in the CFR;
? On an EPA Web page;
? As a table or fact sheet available from an EPA designated contact;
? Using a combination of these approaches or other suggestions.
2. EPA requests comment on the type of information that should be
included in the Federal Register notice when new method approvals are
published using the expedited process. Is a list of the methods being
approved sufficient or should the notice include additional
information? If additional information is suggested, please indicate
the types of information that are desirable and why.
3. EPA requests comment concerning the usefulness of amending
future regulatory text to describe where a list of methods approved
using the expedited process can be obtained. If such a change is
desired, should a reference to the list be included:
? With each methods table;
? In 40 CFR 141.27 under Alternate Test Methods.
? Is there a better suggestion?
4. EPA requests comment on the format of the table that lists
methods approved using the expedited approval process. Does the example
provided in this notice provide enough information in a usable format
or are there better suggestions for listing the information?
5. EPA invites Primacy Agencies to comment on how methods approved
under this new procedure will be implemented in their programs and if
there are concerns that EPA can address when implementing this new
approval process (in order to simplify or expedite Primacy Agency
acceptance of the alternative methods).
V. References
American Public Health Association (APHA). 2004. Standard Method
6610-04. Carbamate Pesticides--High-Performance Liquid Chromatographic
Method. Standard Methods Online. (Available at
http://www.standardmethods.org.) USEPA. 2001. 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. 2003. 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.)
Dated: March 30, 2007.
Benjamin H. Grumbles,
Assistant Administrator, Office of Water.
[FR Doc. E7-6726 Filed 4-9-07; 8:45 am]
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