[Federal Register: November 8, 2004 (Volume 69, Number 215)]
[Proposed Rules]
[Page 64707-64710]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08no04-24]
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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 telliard.william@epa.gov.
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:
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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.
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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