[Federal Register Volume 69, Number 215 (Monday, November 8, 2004)]
[Proposed Rules]
[Pages 64707-64710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24823]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 136

[OW-2003-0002; FRL-7834-9]
RIN 2040-AD53


Guidelines Establishing Test Procedures for the Analysis of 
Pollutants; Procedures for Detection and Quantitation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; withdrawal.

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SUMMARY: On March 12, 2003, EPA published a document in the Federal 
Register that proposed revisions to the regulations for the definition 
and procedure for EPA's method detection limit (MDL). The document also 
proposed to add to these regulations a definition of minimum level of 
quantitation (ML) and a procedure for developing it. The proposed rule 
requested comment on the revisions and additions. The MDL and ML are 
used to characterize the capabilities of analytical test procedures 
applied under the Clean Water Act (CWA). The proposed revisions were 
based on EPA's 2003 assessment of approaches to determining detection 
and quantitation capabilities of analytical methods.
    Today's document withdraws the proposed revisions. The proposed 
revisions were disfavored by the vast majority of commenters on the 
March 2003 proposed rule, and the Agency has determined that these 
proposed revisions do not represent the most effective way to address 
the public's and EPA's concerns regarding approaches to, and use of, 
detection and quantitation values. The Agency believes, preliminarily, 
that new approaches submitted in comments to the proposed rule might 
better address the issues EPA sought to address in its proposed 
revisions and that these new approaches warrant further consideration 
and refinement. Hence, EPA plans to work with stakeholders to evaluate 
one or more approaches to detection and quantitation that will satisfy 
the needs of programs, regulations, and initiatives at the Federal 
level for use of detection and quantitation procedures, and to revise 
its existing procedures, as appropriate.

DATES: For judicial review purposes, this action is considered issued 
as of November 8, 2004. Under section 509(b)(1) of the Clean Water Act, 
judicial review of the Administrator's action regarding guidelines 
establishing test procedures for analysis of pollutants can only be had 
by filing a petition for review in the United States Court of Appeals 
within 120 days after the decision is considered issued for purposes of 
judicial review. Under 40 CFR 23.12, if within ten days of the issuance 
date of this action for purposes of judicial review EPA's General 
Counsel receives two or more petitions filed in two or more United 
States Courts of Appeals, the General Counsel will notify the United 
States Judicial Panel of Multidistrict Litigation of all petitions 
received within the ten day period.

ADDRESSES: The docket for today's action is available for public 
inspection under Docket ID No. OW-2003-0002 at the Water Docket in the 
EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution 
Ave., NW., Washington, DC.

FOR FURTHER INFORMATION CONTACT: William A. 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:

[[Page 64708]]

I. General Information

A. What Entities Are Potentially Interested in This Action?

    Because EPA is withdrawing proposed regulatory changes, this action 
should not have any concrete effects on any entity. Various groups may, 
however, be interested in today's decision. EPA regions, as well as 
States, Territories and Tribes authorized to implement the National 
Pollutant Discharge Elimination System (NPDES) program, issue permits 
that comply with the technology-based and water quality-based 
requirements of the Clean Water Act (CWA). In doing so, NPDES 
permitting authorities, including authorized States, Territories, and 
Tribes, make a number of discretionary choices associated with permit 
writing, including the selection of pollutants to be measured and, in 
many cases, limited in permits. If EPA has ``approved'' standardized 
testing procedures under 40 CFR part 136 for the measurement of a given 
pollutant, the NPDES permit must require such analysis to be done in 
accordance with one of the approved testing procedures or an approved 
alternate test procedure. Many of the testing procedures approved by 
EPA include a specification for detection and quantitation levels that 
laboratories can be expected to achieve. Therefore, entities with NPDES 
permits may be interested in EPA's withdrawal of the proposed revisions 
to the detection and quantitation procedures. In addition, States, 
Territories and Tribes must use the standardized testing procedures and 
achieve the associated detection and quantitation levels when providing 
certification of Federal licenses under Clean Water Act section 401. 
Categories and entities that may be interested in today's decision 
include:

------------------------------------------------------------------------
                                             Examples of potentially
                Category                       interested entities
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State, Territorial, and Indian Tribal    States, Territories, and Tribes
 Governments.                             authorized to administer the
                                          NPDES permitting program;
                                          States, Territories, and
                                          Tribes providing certification
                                          under Clean Water Act section
                                          401.
Industry...............................  Facilities that must conduct
                                          monitoring to comply with
                                          NPDES permits.
Public.................................  Individuals and groups that
                                          follow, comment on, or
                                          otherwise participate in NPDES
                                          permit proceedings.
Municipalities.........................  POTWs that must conduct
                                          monitoring to comply with
                                          NPDES permits.
Environmental Laboratories.............  Public or private laboratories
                                          that conduct compliance-
                                          monitoring analyses for NPDES
                                          permits.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be interested in this 
decision. This table lists the types of entities that EPA believes may 
potentially be interested in this decision. Other types of entities not 
listed in the table may also be interested. If you have questions 
regarding the applicability of this action to a particular entity, 
consult the person listed in the preceding FOR FURTHER INFORMATION 
CONTACT section.

B. How Can I Get Copies of This Document and Other Related Information?

    1. Docket. We have established an official public docket for this 
document under Docket ID No. OW-2003-0002. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, the March 12, 2003, document, and other 
supporting information related to this action. Information claimed as 
CBI and other information whose disclosure is restricted by statute, or 
which is not included in the official public docket, will not be 
available for public viewing in EPA's public docket. 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 20460. 
This Docket Facility 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. To view docket materials, please call 
ahead to schedule an appointment. Every user is entitled to copy 266 
pages per day before incurring a charge. The Docket may charge 15 cents 
for each page over the 266-page limit plus an administrative fee of 
$25.00.
    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 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. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, or which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
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.B.1.

C. What Other Information Is Available To Support This Action?

    You can obtain electronic copies of this document as well as copies 
of major supporting documents at EPA Dockets at http://www.epa.gov/edocket/ and http://www.epa.gov/waterscience.

II. Legal Authority

    This action withdraws EPA's March 12, 2003, proposed revisions to 
40 CFR part 136 and the proposed addition to 40 CFR part 136.2. We take 
this action pursuant to sections 301(a), 304(h), and 501(a) of the 
Clean Water Act, 33 U.S.C. 1311(a), 1314(h) and 1361(a).

III. Background

A. Test Procedures Used for Clean Water Act Programs

    EPA proposes and promulgates test procedures at 40 CFR part 136 in 
accordance with section 304(h) of the CWA, which requires that the EPA 
Administrator ``promulgate guidelines establishing test procedures for 
the analysis of pollutants'' to be monitored and regulated under the 
National Pollutant Discharge Elimination System (NPDES). Test 
procedures are also known as analytical methods. EPA draws the 
analytical methods from a variety of sources, including methods 
developed by commercial vendors, EPA, and other government agencies, as 
well as methods from voluntary consensus

[[Page 64709]]

standards bodies (VCSBs) such as the American Public Health Association 
(APHA), the Water Environment Federation (WEF), and the American Water 
Works Association (AWWA), which jointly publish Standard Methods for 
the Examination of Water and Wastewater, the Association of Official 
Analytical Chemists (AOAC-International); and the American Society for 
Testing and Materials (ASTM International). An analytical method 
promulgated by EPA under CWA section 304(h) is considered approved by 
EPA for purposes of EPA's NPDES permitting regulations.
    Among considerations for approval of an analytical method at 40 CFR 
part 136 are the demonstrated performance characteristics of precision, 
bias, and sensitivity (i.e., detection and quantitation). EPA generally 
evaluates each of these characteristics to determine if the analytical 
method will yield results at concentrations of concern that are 
reliable enough to meet Agency needs for permitting and compliance 
monitoring under the CWA. Detection and quantitation limits have been 
the most controversial of these characteristics, particularly among 
members of the regulated community.

B. Settlement Agreement

    Following promulgation of a new EPA analytical method at 40 CFR 
part 136 on June 8, 1999 (64 FR 30417), 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. 
This lawsuit challenged specific aspects of the analytical method and 
the procedures used to establish method detection limits (MDLs) and 
minimum levels of quantitation (MLs) in all chemical analytical methods 
under the CWA. 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'').
    Under the settlement agreement, EPA agreed to assess the procedures 
currently used by the Agency for determining detection and quantitation 
limits, as well as consider alternate procedures. EPA agreed to sign a 
notice for publication in the Federal Register on or before February 
28, 2003, and to invite public comment on its assessment. The 
settlement agreement also stated that EPA may propose modifications to 
the existing procedures for detection and quantitation. EPA signed the 
notice by the agreed date and, on March 12, 2003 (68 FR 11791), 
published a notice announcing the availability of its assessment. The 
document was entitled Technical Support Document for the Assessment of 
Detection and Quantitation Approaches (EPA-821-R-03-005, February 
2003). In a separate document on the same day, EPA proposed revisions 
to the Agency's existing MDL procedure at 40 CFR part 136 (68 FR 
11770). EPA provided a 120-day public comment period on both documents, 
and reopened the comment period for an additional 30 days, in response 
to requests from the Petitioners. Today's document announces EPA's 
final action withdrawing the revisions to 40 CFR part 136 that were 
proposed on March 12, 2003.
    Under the settlement agreement, as amended, EPA also agreed to sign 
a notice taking final action on the assessment described above on or 
before November 1, 2004. In a separate Federal Register notice, EPA is 
also announcing the availability of a revised assessment document that 
addresses comments and procedures submitted in response to the 2003 
assessment.

IV. Summary of Proposed Rule

    In the March 2003 proposed rule, EPA proposed to revise certain 
aspects of the existing procedure for determining the MDL in 40 CFR 
part 136, appendix B (Definition and Procedure for the Determination of 
the Method Detection Limit). EPA also requested comment on whether to 
add a definition of quantitation limit to part 136, and whether to add 
a procedure for determining the ML to appendix B. Details of the 
proposed revisions are presented and discussed in section VII of the 
March 2003 proposed rule, and include: (1) Proposed revisions to the 
definition of the MDL; (2) proposed technical revisions to the MDL 
procedure; (3) proposed clarifications and other minor editorial 
changes to the MDL procedure codified in part 136; and (4) a proposed 
definition of quantitation limit (ML) and a proposed procedure to 
calculate the ML.
    In section VII.E of the preamble to the March 2003 proposed rule, 
EPA explained that the Agency continues to approve analytical methods 
from organizations that do not necessarily use EPA's MDL and ML 
procedures. EPA also recognized that there are alternative detection 
and quantitation approaches that may be used by method developers to 
determine analytical method sensitivity, and noted that the Agency 
includes analytical methods at 40 CFR part 136 that employ alternative 
approaches. In the preamble to the proposed rule, EPA specifically 
stated that ``the use of detection and quantitation approaches from 
voluntary consensus standards bodies and other organizations is 
encouraged under the National Technology Transfer and Advancement 
Act.'' EPA also included in the proposed revisions to appendix B the 
statement that ``an alternative procedure may be used (e.g., from a 
voluntary consensus standards body) to establish the sensitivity of an 
analytical method, provided the resulting detection limit meets the 
sensitivity needs for the specific application.''

V. Summary of Major Comments

    EPA received more than one hundred comment letters raising issues, 
concerns or suggestions on the proposed rule. EPA received comments 
from 23 laboratories, 31 wastewater treatment plants, three Federal 
agencies, 11 State and county agencies, 23 industrial firms, three 
instrument manufacturers, 19 trade organizations, four consultants, 
eight individuals, and one law firm representing the Petitioners. A 
summary of public comments and EPA's responses are included in the 
Response to Comments document, which is in the official public docket 
supporting this action.
    Although a few commenters suggested that EPA adopt the revisions as 
proposed, most commenters noted that the proposed modifications are 
minor and do not attempt to make the fundamental changes that these 
commenters believe would be more appropriate. For example, some 
commenters stated that EPA's proposed MDL revisions do not sufficiently 
account for all sources of routine inter- and intra-laboratory 
variability. Many of these commenters expressed support for concepts 
that were included with comments submitted by the U.S. Geological 
Survey and the American Council of Independent Laboratories. Other 
commenters suggested that EPA adopt detection and quantitation 
procedures published by ASTM International's Committee D19 on Water 
(i.e., interlaboratory detection and quantitation estimates, known by 
the acronyms IDE and IQE.)
    Commenters also questioned the appropriateness of the MDL and ML 
for all of the different uses for which the MDL and ML are employed in 
Clean Water Act programs. Commenters asserted that a single procedure 
is not appropriate for determining detection or quantitation limits 
that can appropriately support all CWA uses, such as a start-up test in 
a single laboratory, a value characterizing a given analytical method, 
a benchmark

[[Page 64710]]

for approval of a method modification or alternate test procedure, and 
a reporting or compliance limit. Several commenters stated that EPA, 
permit holders, and laboratories would be better served if detection 
and quantitation were determined through approaches quite different 
from those proposed.
    Some commenters encouraged EPA to allow use of alternative 
procedures for determining detection and quantitation levels. Some 
commenters suggested that, like EPA's MDL and ML, other available 
concepts fall short of providing optimal procedures. For example, 
comments submitted by some laboratories indicated that the proposal 
submitted by the Inter-industry Analytical Group, which was discussed 
in the preamble to the March 2003 proposed rule, would be useful only 
during initial phases of method development, but not as a routine 
laboratory tool to assess lab performance. Other commenters noted that 
the IDE and IQE procedures published by ASTM's D19 committee, which 
were discussed in the 2003 assessment of detection and quantitation 
approaches, also are intended only for interlaboratory use and are not 
appropriate for use in a single laboratory.
    Other commenters recommended that EPA contact the editorial 
committees of voluntary consensus standards bodies to begin a process 
of developing detection and quantitation procedures. Several commenters 
requested that EPA reconsider the proposal and work with stakeholders 
to devise an approach that meets the Agency's needs, rather than 
proceeding with the proposed revisions to the MDL.
    In response to these comments, EPA has decided to withdraw the 
proposed rule and has initiated a process to work with stakeholders on 
revisions to MDL and ML procedures. See Potential Stakeholder Process 
for Detection and Quantitation Procedures, 69 FR 55547, September 15, 
2004.

VI. Decision To Withdraw Proposal

    In today's action, EPA is withdrawing the March 12, 2003, proposal 
to revise the MDL definition and procedure and to add a definition and 
procedure for determining the ML. EPA has decided to withdraw these 
proposed revisions because the Agency has concluded that approaches 
other than those set forth in the 2003 proposal have the potential for 
addressing concerns regarding development and use of detection and 
quantitation limits, and that those approaches warrant further 
consideration and refinement. The Agency generally sees merit in 
comments suggesting that EPA should continue to work collaboratively 
with stakeholders on these issues. EPA also notes that the comments 
generally disfavored the proposed revisions, and that there is no 
agreement among critics of the existing MDL and ML procedures about 
what changes should be adopted by the Agency for use in CWA programs.

VII. Effect of Today's Action on Existing MDL Procedure

    EPA plans to explore alternative concepts and approaches submitted 
in response to the two March 2003 Federal Register documents. These 
comments included sometimes detailed alternative approaches or other 
revisions to current EPA detection and quantitation procedures. EPA 
intends to further evaluate issues and detection and quantitation 
approaches suggested by commenters, and to solicit additional 
stakeholder input through consultations. The Agency believes that the 
body of public comment on the proposed rule provides a strong starting 
point for a continued collaborative consultation with stakeholders 
representing constituencies such as citizens, environmental 
organizations, permit writers, regulators and regulated industries. In 
a Federal Register notice published on September 15, 2004 (69 FR 
55547), EPA announced that a neutral party is seeking a broad group of 
stakeholders willing to work together to define and address concerns 
about the way detection and quantitation values are calculated and used 
to support CWA programs. Such a process, if feasible, could begin as 
early as December 2004.
    The existing MDL procedure has been in place since 1984. Individual 
MDLs and MLs are included in many EPA-approved methods at 40 CFR part 
136, and have provided laboratories and data users with limits for 
evaluating results of analytical measurements or analytical method 
selection. Although several commenters expressed concern with a number 
of technical and applicability issues regarding EPA's current MDL and 
ML procedures (and EPA finds merit in this concern), other commenters 
supported their continued use because, in their experience, the MDL and 
ML values published in many of the approved EPA methods have served 
acceptably as default detection and quantitation levels for permits. By 
today's action, EPA leaves the existing MDL procedure unchanged while 
it further considers the concerns raised by commenters.

VIII. Statutory and Executive Order Reviews

    Today's action does not constitute a rule under section 551 of the 
Administrative Procedure Act, 5 U.S.C. 551. Hence, requirements of 
other regulatory statutes and Executive Orders that generally apply to 
rulemakings (e.g., the Unfunded Mandate Reform Act) do not apply to 
this action.

    Dated: November 1, 2004.
Michael O. Leavitt,
Administrator.
[FR Doc. 04-24823 Filed 11-5-04; 8:45 am]
BILLING CODE 6560-50-P