[Federal Register: March 12, 2003 (Volume 68, Number 48)]
[Proposed Rules]
[Page 11791-11793]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12mr03-20]
[[Page 11791]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 136
[FRL-7462-9]
Technical Support Document for the Assessment of Detection and
Quantitation Concepts
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of document availability and public comment period.
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SUMMARY: Today's action announces the availability of a recent
assessment of detection and quantitation procedures used by EPA to
determine the sensitivity of analytical (test) methods under EPA's
Clean Water Act (CWA). EPA's method detection limit (MDL) and minimum
level of quantitation (ML) are used to define test sensitivity under
the CWA. The MDL is used to determine the lowest concentration at which
a substance is detected or is ``present'' in a sample. The ML appears
in many EPA methods and has been used to describe the lowest
concentration of a substance that gives a recognizable signal, or as a
quantitation limit. The Assessment Document includes an evaluation of
the MDL and ML procedures and alternative approaches for defining test
sensitivity. This Assessment Document has been peer-reviewed and is now
available for public review and comment.
DATES: Comments must be postmarked, delivered by hand, or
electronically mailed on or before July 10, 2003. Comments provided
electronically will be considered timely if they are submitted
electronically by 11:59 p.m. Eastern Time on July 10, 2003.
ADDRESSES: Comments may be submitted by mail to Water Docket, U.S.
Environmental Protection Agency (4101T), 1200 Pennsylvania Avenue NW.,
Washington DC 20460, or electronically through EPA Dockets at http://
www.epa.gov/edocket/
, Attention Docket ID No. OW-2003-0003. See Unit C
www.epa.gov/edocket/, Attention Docket ID No. OW-2003-0003. See Unit C
of the SUPPLEMENTARY INFORMATION section for additional ways to submit
comments and more detailed instructions.
FOR FURTHER INFORMATION CONTACT: William Telliard; Engineering and
Analysis Division (4303T); Office of Science and Technology; Office of
Water; U.S. Environmental Protection Agency; Ariel Rios Building; 1200
Pennsylvania Avenue NW., Washington, DC 20460, or call (202) 566-1061
or e-mail at telliard.william@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. How Can I Get Copies of This Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under Docket ID No. OW-2003-0003. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
The official public docket is the collection of materials that is
available for public viewing at the Water Docket in the EPA Docket
Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave., NW.,
Washington, DC. The EPA Docket Center is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is (202) 566-1744, and the telephone
number for the Water Docket is (202) 566-2426.
2. Electronic Access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. An electronic version of the
listings at http://www.epa.gov/fedrgstr/. An electronic version of the
public docket is available through EPA's electronic public docket and
comment system, EPA Dockets. You may use EPA Dockets at http://
www.epa.gov/edocket/
to submit or view public comments, to access the
www.epa.gov/edocket/ to submit or view public comments, to access the
index listing of the contents of the official public docket, and to
access those documents in the public docket that are available
electronically. Once in the system, select ``search,'' then key in the
appropriate docket identification number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the docket
facility identified in I.A.1.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the Docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
B. How and to Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket identification number in the subject line on the
first page of your comment. Please ensure that your comments are
submitted within the specified comment period. Comments received after
the close of the comment period will be marked ``late.'' EPA is not
required to consider these late comments. However, late comments may be
considered if time permits.
1. Electronically. If you submit an electronic comment as
prescribed below, EPA recommends that you include your name, mailing
address, and an e-mail address or other contact information in the body
of your comment. Also include this contact information on the outside
of any disk or CD ROM you submit, and in any cover letter accompanying
the disk or CD ROM. This ensures that you can be identified as the
submitter of the comment and allows EPA to contact you in case EPA
cannot read your comment due to technical difficulties or needs further
information on the substance of your comment. EPA's policy is that EPA
will not edit your comment, and any identifying or contact information
provided in the body of a comment will be included as part of the
comment that is placed in the official public docket, and made
available in EPA's electronic public docket. 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.
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i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/
edocket
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in Docket ID No.
OW-2003-0003. The system is an ``anonymous access'' system, which means
EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by electronic mail (e-mail) to OW-
docket@epa.gov Attention Docket ID No. OW-2003-0003. In contrast to
EPA's electronic public docket, EPA's e-mail system is not an
``anonymous access'' system. If you send an e-mail comment directly to
the Docket without going through EPA's electronic public docket, EPA's
e-mail system automatically captures your e-mail address. E-mail
addresses that are automatically captured by EPA's e-mail system are
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in I.B.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By Mail. Send an original and three copies of your comments to:
Water Docket, Environmental Protection Agency, Mailcode: 4101T, 1200
Pennsylvania Ave., NW., Washington, DC, 20460, Attention Docket ID No.
OW-2003-0003.
3. By Hand Delivery or Courier. Deliver your comments to EPA Docket
Center (EPA/DC), EPA West, Room B102, 1301 Constitution Avenue, NW.,
Washington, DC, Attention Docket ID No. OW-2003-0003. Such deliveries
are only accepted during the Docket's normal hours of operation as
identified in I.A.1.
C. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
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 CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any 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 and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person identified in the FOR FURTHER INFORMATION CONTACT section.
D. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide any technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period
deadline.
8. Ensure proper receipt by EPA by identifying the appropriate
docket identification number in the subject line on the first page of
your response. It would also be helpful if you provided the name, date,
and Federal Register citation related to your comments.
II. Summary of EPA's Assessment
EPA completed an assessment for determining the sensitivity of
analytical test methods (i.e., procedures for determining detection and
quantitation) and their application to Clean Water Act (CWA) programs.
The assessment examines the method detection limit (MDL) and minimum
level of quantitation (ML) procedures currently used by the Agency for
determining test sensitivity for CWA applications. It also considers
alternative concepts and procedures. EPA conducted the assessment to
partially fulfill certain provisions of a settlement agreement with the
Alliance of Automobile Manufacturers, et al., which is discussed
further below.
On June 8, 1999, EPA published a final rule adding EPA Method 1631,
Revision B: Mercury in Water by Oxidation, Purge and Trap, and Cold
Vapor Atomic Fluorescence Spectrometry (Method 1631) to the
``Guidelines Establishing Test Procedures for the Analysis of
Pollutants'' under section 304(h) of the Clean Water Act. Following
promulgation, the Alliance of Automobile Manufacturers, the Chemical
Manufacturers Association, and the Utility Water Act Group
(``Petitioners'') and the American Forest and Paper Association
(``Intervenor'') filed a lawsuit challenging the method. The challenge
addressed specific aspects of EPA Method 1631 as well as the general
procedures used to establish the method detection limit (MDL) and
minimum level of quantitation (ML) specified in the method. On October
19, 2000, EPA entered into a settlement agreement with the Petitioners
and Intervenor (Alliance of Automobile Manufacturers, et al. v. EPA,
No. 99-1420 (D.C. Cir.); the ``settlement agreement'').
Clause 6 of the settlement agreement provides for EPA to assess
existing Agency and alternative procedures for determining detection
and quantitation limits under the Clean Water Act and to sign a notice
for publication in the Federal Register on or before February 28, 2003,
inviting comment on the assessment. The settlement agreement further
provides for EPA to submit its assessment to formal peer review by
experts in the fields of analytical chemistry and in the statistical
aspects of analytical data interpretation. EPA drafted an Assessment
Document describing the issues associated with the assessment process,
the detection and quantitation concepts and procedures evaluated, the
criteria used for the evaluation, the evaluation results, and the
conclusions of the assessment. EPA then conducted a peer review of the
draft Assessment Document in August 2002. As stipulated in the
settlement agreement, EPA provided the draft Assessment Document to the
Petitioners and Intervenor for concurrent review and comment in August
2002.
Following peer review, EPA revised the Assessment Document to
incorporate peer review comments. The revised assessment is contained
in a document titled, ``Technical Support Document for the Assessment
of Detection and Quantitation Concepts'' (EPA 821- R-03-005, February,
2003), or ``Assessment Document.'' The
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Assessment Document, the peer review comments, and comments from the
Petitioners and Intervenor are available in the docket for this notice.
The purpose of this notice is specifically to request comment on the
Assessment Document.
Elsewhere in today's Federal Register, the Agency is proposing
revisions to the MDL definition and procedure codified at 40 CFR part
136, Appendix B, and is also proposing to add a definition of the ML at
40 CFR 136.2. The proposed revisions are based on the findings from the
assessment and are fully discussed in the proposed rule. To comment on
these proposed revisions, readers are referred to the Proposed Rules
section of today's Federal Register for the Guidelines Establishing
Test Procedures for the Analysis of Pollutants; Procedures for
Detection and Quantitation.
The settlement agreement stipulates that EPA's assessment of
concepts and procedures for detection and quantitation be submitted for
public review and comment for a period of no less than 120 days. The
settlement agreement also requires EPA to sign a final notice taking
action on the assessment on or before September 30, 2004. By this
notice, EPA invites the public to comment on the Assessment Document.
The public comment period is open for 120 days and will close on July
10, 2003.
After EPA considers public comments, it will publish a notice
taking final action on the assessment by September 30, 2004.
Dated: February 28, 2003.
Christine Todd Whitman,
Administrator.
[FR Doc. 03-5711 Filed 3-11-03; 8:45 am]
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