UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
I WASHINGTON, D,C, 20460
OFFICE OF tMe ADMINISTRATOR
* -i OA irt«* SCIENCE ADVISORY BOARD
April 30, 1993
EPA-SAB-DWC-COM-93-002
Honorable Carol M. Browner
Administrator
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Subject: Science Advisory Board's Commentary on "Requirements
for Nationwide Approval of New and Optionally Revised
Methods for Inorganic and Organic Analyses in National
Primary Drinking Water Regulations Monitoring"
Dear Ms. Browner:
On April 19, 1993, the Drinking Water Committee of EPA's Science Advisory
Board (SAB) received a briefing concerning the "Requirements for Nationwide
Approval of New and Optionally Revised Methods for Inorganic and Organic
Analyses in National Primary Drinking Water Regulations Monitoring" (Revision
1.1, dated 4/14/93), This document was prepared by the Office of Research and
Development and is often identified as the "Alternative Testing Procedxo-e
Protocol" (ATP). The Office of Groundwater and Drinking Water (OGWDW) had
requested input from the SAB on this document kte last year, and the Drinking
Water Committee had received an earlier version (Eevision 1.0, dated 7/7/92)
before its meeting of February 1993, but had not been able to discuss it at that
time. The overview of the ATP provided to the Committee included: a historical
background of the activities of the Environmental Monitoring Systems Lab
(EMSLrCincinnati) with regard to water testing methods; a description of the
two-tiered system in the ATP; general requirements of the application; and
EMSL-Gincinnatf s evaluation procedure. The Drinking Water Committee has
decided on its own initiative to provide this commentary on the ATP.
From 1978 to-date, a total of 1250 alternative testing procedures were received
by the US EPA under the mechanism promulgated in Section 141.27 of Title 40 of
the Code of Federal Regulations (CFR). For drinking water, a total of 320
procedures have been approved, one hundred forty-four of them for nationwide use
and 176 for limited use. Eighty-eight percent of these 320 were for chemical
procedures.
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The US EPA is proposing to repeal this regulation and establish, in its place,
a two-tiered system for rapid nationwide adoption of new and revised analytical
methods for drinking water. The first tier is for any new method, significantly
revised method, or a new application of a currently approved method. The second
tier will cover optional minor modifications of an approved method.
The following are our findings and recommendations with regard to the
ATP:
a) The ATP requires the use of 10 drinking water sources (6 surface and
4 groundwater). This number is too small to adequately represent
the nation's diversity in water quality and treatment conditions.
There should be guidance as to the range of water qualities to be
sampled and less emphasis based on the samples representing 10
regions of the country. The water quality variables should include
pH, TOG (Total Organic Carbon), alkalinity, and TOX (Total Organic
Halides), similar to those currently under consideration in the
Regulatory Negotiation process for Disinfectants and Disinfection by-
Products. For example, TOGs ranging from concentrations below
2mg/L to concentrations above 8 mg/L should be included. TOX
ranging from 50 to 500 ug/L should be used when appropriate to
challenge the proposed method.
b) The ATP suggests testing methods at four concentrations. This
number may be inappropriate in certain cases. The concentrations
should include a level that is five times the method detection limit
(MDL), a level that is two times the maximum contaminant level
(MOD and additional levels that take into account the dynamic range
on a case-by-case basis.
c) We are not clear how the ATP program may impact other methods-
developing organizations (e.g., joint APHA/AWWA/WEF, ASTM).
d) During the briefing, the possibility of performance-based standards for
analytical methods was discussed, although changes along these Hues
are not currently under consideration for the proposed two-tiered
ATP process. Developments along this line would have some
potential advantages and we encourage them. However, we are
concerned about the practical application of this approach across a
wide variety of methods for an increasingly complex group of
chemicals. Caution should be exercised in approving laboratory
methods with detection capabilities very near the MCL, because then-
use may result in loss of valuable monitoring data at levels below the
MCL, with little savings in cost or efficiency.
In general, facilitation of the ATP process should encourage the development
and use of procedures which serve to improve the efficiency and reduce the cost of
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contaminant analysis. We request, however, that the scientific merits of any
changes to a performance-based standard approach be provided to the Committee
with appropriate time for a detailed review of the approach and its potential
impact on the industry.
The SAB appreciates the opportunity to assist and provide suggestions on
issues such as these, which can eventually permit better monitoring strategies to
be adopted by the Agency, and we look forward to your response to the comments
contained in this letter.
Sincerely,
Dr. ^Raymond C. Loehr, Chair
Executive Committee
Science Advisory Board
Ray,
Drinking Water CoiMuttee
Science Advisory Board
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NOTICE
This report has been written as a part of the activities of the Science Advisory
Board, a public advisory group providing extramural scientific information and
advice to the Administrator and other officials of the Environmental Protection
Agency, The Board is structured to provide balanced, expert assessment of
scientific matters related to problems facing the Agency. This report has not been
reviewed for approval by the Agency and, hence, the contents of this report do not
necessarily represent the views and policies of the Environmental Protection
Agency, nor of other agencies in the Executive Branch of the Federal government,
nor does mention of trade names or commercial products constitute a
recommendation for use.
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ENV1EONMENTM, PROTECTION AGENCY
SCIENCE ADVISORY BOARD
DRINKING WATER COMMITTEE
Commentary on Alternative Testing Protocol Procedure (ATP)
CHAIBMAM
Dr. Verne A Bay, Medical Research Laboratory, Pfizer Inc., Groton,
Connecticut
MEMBERS
Dr. Richard J. BuU, College of Pharmacy, Washington State University,
Pullman, Washington
Dr. Gary P, Carlson, Department of Pharmacology and Toxicology, School of
Pharmacy, Purdue University, West Lafayette, Indiana
Dr. Keith E. Cams, East Bay Municipal Utility District, Oakland, California
Dr. Lenore S. Clesceri, Rensselaer Polytechnic Institute, Materials Research
Center, Troy, New York
Dr. Ramon G, Lee, American Water Works Service Company, Voorhees, New
Jersey
Dr. Edo D. PeUizzari, Research Triangle Institute, Research Triangle Park,
North Carolina
Dr. Mark D, Sdbsey, Department of Environmental Sciences and Engineering,
School of Public Health, University of North Carolina, Chapel Hill, North
Carolina
Dr. James M. Symons, Department of Civil and Environmental Engineering,
University of Houston, Houston, Texas
3QRY BOARD STAFF
Mr. Manuel R. Gomez, Designated Federal Official, Science Advisory Board
(A-101F), ILS. EPA, 401 M Street, SW, Washington, DC 20460
Mrs. Marcy Joly, Staff Secretary, Drinking Water Committee, Science
Advisory Board (A-101F), U.S. EPA, 401 M Street, SW, Washington, DC
20460
'•M*
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Deputy Administrator
Assistant Administrators
EPA Regional Administrators
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Director, Office of Ground Water and Drinking Water
Director, Office of Science and Technology
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Director, Environmental Monitoring and Assessment Program
Environmental Monitoring Management Council
Director, Risk Assessment Forum
EPA Headquarters Library
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ENVIRONMENTAL PROTECTION AGENCY
SCIENCE ADVISORY BOARD
DRINKING WATER COMMITTEE
Commentary on Alternative Testing Protocol Procedure (ATP)
CHAIRMAN
Dr. Verne A. Bay, Medical Research Laboratory, Pfizer Inc., Groton,
Connecticut
MTCMTfflRS
Dr. Richard J. Bull, College of Pharmacy, Washington State University,
Pullman, Washington
Dr. Gary P. Carlson, Department of Pharmacology and Toxicology, School of
Pharmacy, Purdue University, West Lafayette, Indiana
Dr. Keith E. Cams, East Bay Municipal Utility District, Oakland, California
Dr. Lenore S. Cleseeri, Kensselaer Polytechnic Institute, Materials Research
Center, Troy, New York
Dr. Ramon G. Lee, American Water Works Service Company, Voorhees, New
Jersey
Dr. Edo D. Peffizzari, Eesearch Triangle Institute, Eesearch Triangle Park,
North Carolina
Dr. Mark D. Sobsey, Department of Environmental Sciences and Engineering,
School of Public Health, University of North Carolina, Chapel Hill, North
Carolina
Dr. James M, Symons, Department of Civil and Environmental Engineering,
University of Houston, Houston, Texas
SCIENCE ADVISORY BOARD STAFF
Mr. Manuel R. Gomez, Designated Federal Official, Science Advisory Board
(A-101F), U.S. EPA, 401 M Street, SW, Washington, DC 20460
Mrs. Marcy Jolly, Staff Secretary, Drinking Water Committee, Science
Advisory Board (A-101F), U.S. EPA, 401 M Street, SW, Washington, DC
20460
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Distribution List
Administrator
Deputy Administrator
Assistant Administrators
BPA Regional Administrators
EPA Laboratory Directors
Director, Office of Ground Water and Drinking Water
Director, Office of Science and Technology
Office of Modeling, Monitoring Systems, and Quality Assurance
Director, Environmental Monitoring and Assessment Program
Environmental Monitoring Management Council
Director, Risk Assessment Forum
EPA Headquarters Library
EPA Regional Libraries
EPA Laboratory Libraries
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