Document ID: EPA-HQ-OW-2006-0958-0001
Agency: epa
Document Type: Notice
Title: Expedited Approval of Test Procedures for the Analysis of Contaminants Under the Safe Drinking Water Act; Analysis and Sampling Procedures
Posted Date: 2007-04-10T04:00Z

[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
----------------------------------------------------------------------------------------------------------------
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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