EPA
United States
Environmental Protection
Agency
Office of Water 4303
EPA-821-F-01-002
January 2001
Sheet
Office of Water Approval Program for New
and Alternate Test Procedures
Summary
EPA is responsible for approving methods for data gathering and compliance monitoring under the Clean
Water Act and Safe Drinking Water Act. As part of this responsibility, the EPA Office of Water (OW)
maintains a program for organizations outside of EPA to apply for approval of new and alternate test
procedures. Historically, the program has been cumbersome and hard to use, but OW has made several
changes to reduce application requirements and speed up the approval process. OW believes that these
changes will encourage the development of innovative technologies for measuring regulated analytes in
wastewater and drinking water.
Background
The Clean Water Act and Safe Drinking Water Act
require EPA to approve methods for determining
regulated analytes in wastewater and drinking
water. EPA-approved methods are listed in the
Code of Federal Regulations at 40 CFR part 136
for wastewater and at 40 CFR part 141 for
drinking water.
Must I always use an EPA-approved method?
As an option to using EPA-approved methods, you
may apply for approval of a new method or
alternate test procedure (ATP) through the EPA
Office of Water's (OW's) methods approval
program. The ultimate goal of the program is to
encourage the development and approval of new
methods and ATPs that:
• improve method performance
• overcome matrix interferences
reduce test complexity and costs
• reduce the amount of hazardous materials
used or produced in the laboratory
• increase the protection of human health and
the environment
As part of EPA's efforts to implement a
performance-based measurement system (PBMS)
in monitoring programs, OW has made the
methods approval program more accessible by
standardizing and reducing application
requirements, and speeding up the approval
process for both new methods and ATPs. When
PBMS is finalized, you will have additional method
approval options.
What is the difference between a new
method and an ATP?
In general, an ATP uses the same
"determinative technique" (i.e., measurement
technology or test species) as that used in an
EPA-approved method, whereas a new
method uses a determinative technique that is
different from that used in an EPA-approved
method.
How do I prepare an application?
You must document and validate your method
according to the appropriate EPA protocol. The
following protocols are available from OW:
• Protocol for EPA Approval of Alternate Test
Procedures for Organic and Inorganic
Analytes in Wastewater and Drinking Water
Protocol for EPA Approval of New Methods
for Organic and Inorganic Analytes in
Wastewater and Drinking Water
• Protocol for EPA Approval of New or
Alternate Test Procedures for Whole
Effluent Toxicity
These protocols specify validation requirements
that are based on the intended use of the
proposed method. For example, EPA has fewer
validation requirements for a method that is
intended for use in a single laboratory (limited
use) than for a method that will be used
nationwide (nationwide use). In most cases,
the protocols significantly reduce the number of
analyses necessary to validate a method.
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At this time, OW has developed protocols only for
organic and inorganic analytes and whole effluent
toxicity. For other classes of analytes, we strongly
encourage you to contact OW for guidance. OW
will apply the concepts introduced in the above
protocols on a case-by-case basis until additional
protocols are developed.
Where can I get the protocols?
You can download the protocols from the Internet
at http://www.epa.gov/OST/programs.html. For
hardcopies of the protocols, contact the
contractor-operated Sample Control Center at
(703)461-2100.
Where do I submit my application?
Submit limited-use applications to the EPA Region
in which the discharge occurs. Limited-use
applications apply only to wastewater methods.
All drinking water applications must be for
nationwide use. A list of Regional contacts is
provided at the end of this fact sheet.
Submit nationwide-use applications and all
drinking water applications to:
William Telliard, Director
Analytical Methods Staff (4303)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, DC 20460
How does the approval process work?
After submittal to EPA, your application will
pass through a two-stage methods approval
process:
(1) Within OW, the Analytical Methods Staff
(AMS) will track, review, and recommend
approval or disapproval of your application.
For drinking water applications, the Office of
Ground Water and Drinking Water also will
review and recommend approval or
disapproval.
(2) If your application is recommended for
approval, OW will forward it to the final
approval authority.
For limited-use applications, the
appropriate Regional Administrator will
provide a letter of approval.
For nationwide-use applications, the
EPA Administrator will provide approval
through formal rulemaking. After
rulemaking, your method will be listed in
the Code of Federal Regulations as an
approved method.
What is the time table for approving an
application?
For limited-use applications, OW will
recommend approval or disapproval of your
application within 30 days of receipt of a
complete package.* The Regional
Administrator will send you a letter of approval
or disapproval within 60 days of the
recommendation date. (See Figure 1)
Figure 1 - Method Approval Process
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Acronyms:
DW=Drinking Water
LU=Limited-use
NW=Nationwide-use
RA=Regional Administrator
WW=Wastewater
OW
recommends
approval
or
disapproval
J
Approx. 1 year
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For nationwide-use applications, OW will
recommend approval or disapproval or your
application within 90 days of receipt of a complete
package.* Formal rulemaking to list your method
in the Code of Federal Regulations will take up to
an additional year. (See Figure 1)
* OW will consider your application complete
when it contains all elements specified in the
methods approval protocol.
Where can I get help or check on the status of
my application?
For wastewater methods, contact:
Dr. Maria Gomez-Taylor
USEPA Office of Water
Analytical Methods Staff (4303)
401 M Street, S.W.
Washington, D.C. 20460
(202)260-1639
E-mail: gomez-taylor.maria@epa.gov
For drinking water methods, contact:
Dr. Herbert J. Brass
USEPA Office of Water
Technical Support Center (140)
26 Martin Luther King Drive
Cincinnati, Ohio 45268
(513)569-7936
E-mail: brass.herb@epa.gov
For general information or status, you also may
contact the contractor-operated Sample Control
Center at (703) 461-2100.
Regional Contacts
Region 1
Arthur Clark
USEPA Region 1
EQA
60 Westview Street
Lexington, MA 02173
Region 2
Linda M. Mauel
USEPA Region 2
Division of Science and Monitoring
2890 Woodbridge Avenue (MS-220)
Building 10
Edison, NJ 08837-3679
Region 3
Charles Jones
USEPA Region 3
Environmental Assessment and Protection
Division
1650 Arch Street, 3ES-10
Philadelphia, PA 19103-2029
Region 4
Wayne Turnbull
USEPA Region 4
Science & Ecosystems Support Division
980 College Station Road
Athens, GA 30605-2720
Region 5
Kenneth Gunter
USEPA Region 5
77 W. Jackson Blvd.,WT-15J
Chicago, IL 60604
Region 6
David Stockton
USEPA Region 6 Laboratory
Houston Branch
10625 Fallstone Road (6MD-HI)
Houston, TX 77099
Region 7
Doug Brune
USEPA Region 7
901 N. 5th Street
Kansas City, KS 66101
Region 8
Tony Medrano
Regional Quality Assurance Officer
USEPA Region 8
999 18th Street - Suite 500 (8TMS-Q)
Denver, CO 80202-2466
Region 9
Roseanne Sakamoto
USEPA Region 9
75 Hawthorne Street, PMD-3
San Francisco, CA 94105
Region 10
Bruce Woods
USEPA Region 10
200 Sixth Avenue, OEA-095
Seattle, WA 98101
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