[Federal Register Volume 68, Number 48 (Wednesday, March 12, 2003)]
[Proposed Rules]
[Pages 11791-11793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5711]



[[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 
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 [email protected].

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 
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 
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 [email protected] 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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