[Federal Register Volume 62, Number 123 (Thursday, June 26, 1997)]
[Proposed Rules]
[Pages 34574-34599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16735]
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_______________________________________________________________________
Part V
Environmental Protection Agency
_______________________________________________________________________
40 CFR Parts 136 and 141
Guidelines Establishing Test Procedures for the Analysis of Pollutants
and National Primary Drinking Water Regulations; Flexibility in
Existing Test Procedures and Streamlined Proposal of New Test
Procedures; Correction, Announcement of Meetings, and Extension of
Comment; Proposed Rule
Federal Register / Vol. 62, No. 123 / Thursday, June 26, 1997 /
Proposed Rules
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 136 and 141
[FRL-5848-3]
RIN 2040-AC93
Guidelines Establishing Test Procedures for the Analysis of
Pollutants and National Primary Drinking Water Regulations; Flexibility
in Existing Test Procedures and Streamlined Proposal of New Test
Procedures; Correction, Announcement of Meetings, and Extension of
Comment Period
AGENCY: Environmental Protection Agency (EPA).
ACTION: Correction, Announcement of Meetings, and Extension of Comment
Period.
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SUMMARY: EPA is correcting minor errors in the preamble and regulatory
language of its proposed rule to streamline EPA's water methods
approval program, which appeared in the Federal Register on March 28,
1997 (62 FR 14976).
EPA also announces two public meetings on the proposed rule and
extends the comment period from March 28, 1997 to August 1, 1997.
DATES: EPA will conduct two public meetings on streamlining EPA's water
methods approval programs. The first of these meetings will be held on
Thursday, July 17, 1997, in Chicago, Illinois, from 9:00 a.m. to 12:30
p.m. The second of the two meetings will be held on August 1, 1997, in
Dallas, Texas, from 9:00 a.m. to 1:00 p.m. Registration for the
meetings will begin at 8:00 a.m. Public comments regarding the
streamlining proposed rule will be accepted until August 1, 1997.
ADDRESSES: Send written comments to the Streamlining Methods Docket
Clerk, Ben J. Honaker, Water Docket (MC-4101), USEPA, 401 M Street SW,
Washington, DC 20460. The July 17, 1997, meeting will be held at the
Hotel Inter-Continental Chicago located at 505 North Michigan Avenue,
Chicago, Illinois. The August 1, 1997, meeting will be held at the
Wyndham Anatole Hotel-Dallas located at 2201 Stemmons Freeway, Dallas,
Texas.
FOR FURTHER INFORMATION CONTACT: Questions concerning this comment can
be directed to Marion Thompson by phone at (202)260-7117 or by
facsimile at (202)260-7185.
SUPPLEMENTARY INFORMATION:
Background
On March 28, 1997, EPA proposed an initiative to streamline its
water methods approval program (62 FR 14976) (Streamlining Initiative).
The purpose of the Streamlining Initiative is to expand method
flexibility and expedite the method approval process for wastewater and
drinking water methods approved at 40 Code of Federal Regulations (CFR)
parts 136 and 141. This initiative would support a performance-based
approach to environmental measurements under the Clean Water Act and
Safe Drinking Water Act through use of quality control criteria in EPA-
designated reference methods as the baseline standards of method
performance. The initiative would encourage introduction of innovative
technologies and involvement of stakeholders in the method development
process by expediting Agency processes when external organizations
develop and submit for approval new analytical methods. The goal of
streamlining is to facilitate early introduction of new and innovative
technologies that may reduce costs, overcome analytical difficulties,
improve laboratory safety, and enhance data quality, while reducing the
regulatory burden imposed by prescriptive methods.
The Streamlining Initiative was first outlined in a notice in 60 FR
47325 (September 12, 1995). Between September 1995 and July 1996, EPA
held four public meetings to gather input on the Streamlining
Initiative. The suggestions from these meetings were used in refining
the Streamlining Initiative prior to its proposal. The Streamlining
Initiative includes the following elements: standardized quality
control tests in all methods, designation of reference methods that
contain QC acceptance criteria for all standard QC tests, increased
flexibility to modify reference methods without seeking prior EPA
approval provided that the applicant demonstrates method equivalency, a
tiered strategy for validating methods based on their intended use, a
standard method format, suggested standard data elements for reporting,
an amended process for non-EPA organizations to submit new methods for
approval, and more rapid approval procedures.
Extension of Comment Period
EPA is extending the time for receipt of comments until August 1,
1997 to accommodate the two public meetings announced in this notice.
Verbal comments will be accepted at these two public meetings only. All
other comments must be written.
All comments received by August 1, 1997 and submitted in accordance
with these instructions and the instructions in the Notice of Proposed
Rulemaking will be entered into the public record and considered by EPA
before promulgation of the final rule.
Corrections to Proposed Rule Tables
This document corrects three tables that appeared in the
Identification of Test Procedures section of the proposed rule. Several
of the values in the ``Recovery,'' ``Precision,'' ``Spiking Conc,''
``IPR Recovery-Low,'' ``IPR Recovery-High,'' ``OPR Recovery-Low,''
``OPR Recovery-High,'' ``MS/MSD Recovery-Low,'' ``MS/MSD Recovery-
High,'' ``ML Value,'' and ``ML Calc'' columns of Table 1F that appears
on page 15011 of the proposed rule are incorrect. Several of the values
in the ``Recovery,'' ``Precision,'' ``Spiking Conc,'' ``IPR Recovery-
Low,'' ``IPR Recovery-High,'' ``OPR Recovery-Low,'' ``OPR Recovery-
High,'' ``MS/MSD Recovery-Low,'' and ``MS/MSD Recovery-High'' columns
of the table titled, ``Standardized QC and QC Acceptance Criteria for
Methods in 40 CFR 141.23(k)(1),'' that appears on page 15046 of the
proposed rule also are incorrect. This notice provides end notes to
Table 1F that appears on page 15011 of the proposed rule, and the table
titled, ``Standardized QC and QC Acceptance Criteria for Methods in 40
CFR 141.23(k)(1),'' that appears on page 15046 of the proposed rule.
These end notes, which were inadvertently omitted in the proposed rule,
clarify the source of the quality control (QC) criteria that appear in
these tables.
Entries 8 through 11 were inadvertently omitted from the version of
Table 141.40(n)(11) that appears on page 15049 of the proposed rule.
Meeting Arrangements
Arrangements for the public meetings on the streamlining proposed
rule are being coordinated by DynCorp, Inc. For information on
registration, contact Cindy Simbanin, 300 N. Lee Street, Suite 500,
Alexandria, VA 22314. Phone: 703/519-1386; facsimile: 703/684-0610.
Hotel reservations for the meeting on July 17,1997, may be made by
contacting the Hotel Inter-Continental Chicago at 312/944-4100. The
hotel address is 505 North Michigan Avenue, Chicago, Illinois 60611.
When making reservations, specify that you are affiliated with the
``EPA PFPR Workshop'' (the EPA Pesticide Formulating, Packaging and
Repackaging Workshop). Hotel reservations for the meeting on August 1,
1997, may be made by contacting the Wyndham Anatole Hotel-Dallas at
214/748-1200. The hotel address is 2201
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Stemmons Freeway, Dallas, Texas 75207. Guest rates are $84.00,
including tax. Reservations must be made by June 30, 1997. When making
reservations, you must specify that you are affiliated with ``NELAC''
(the National Environmental Laboratory Accreditation Committee) to
qualify for the quoted rate. Accommodations are limited for both
meetings, so please make your reservations early.
Agenda Topics
The purpose of the public meetings in Chicago and Dallas is to
present and discuss EPA's proposed approach to streamlining its water
methods approval program. Each meeting will consist of a brief overview
of the Streamlining Initiative, followed by comments and questions.
The following topics will be addressed at the public meetings:
Increasing flexibility to modify approved methods to
facilitate use of innovative technologies.
Designating reference methods that contain QC acceptance
criteria to support determination of method equivalency when method
modifications are used.
Tiered strategy for validating new methods and method
modifications based on intended use of the method.
Streamlining the method proposal and promulgation process
in order to take advantage of emerging analytical technologies in a
timely manner.
Dated: June 20, 1997.
Robert Perciasepe,
Assistant Administrator for Water.
The following corrections are made in FRL-5800-2, Guidelines
Establishing Test Procedures for the Analysis of Pollutants and
National Primary Drinking Water Regulations; Flexibility in Existing
Test Procedures and Streamlined Proposal of New Test Procedures, which
was published in the Federal Register on March 28, 1997 (62 FR 14976).
1. On page 15011, Table 1F is corrected to read as follows:
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Table 1F Note:
The QC acceptance criteria given in Table 1F were developed from
data published in the following sources. For Method 200.7,
promulgated at 40 CFR Part 136, Appendix C, QC acceptance criteria
were developed using the regression equations at the end of the
method. The concentration given in the Spike Conc column is the
concentration at which the QC acceptance criteria were calculated.
For calculating the precision criterion, the overall standard
deviation (S) was used (not the single-analyst standard deviation
(SR)). For the remaining 200-series metals methods, QC acceptance
criteria were developed from the regression equations in 40 CFR Part
136, Appendix D, where available; otherwise, from performance data
published at the end of each method in Methods for Chemical Analysis
of Water and Wastes (MCAWW; EPA 600/4-79-020; NTIS PB-123677). For
methods other than Method 200.7 and the 200-series metals methods,
data published at the end of each method in MCAWW were used, if
available; otherwise default QC acceptance criteria, as described
below, were used.
The databases used to develop regression equations for Method
200.7 and the 200-series metals methods were not readily available.
Therefore, QC acceptance criteria were calculated using the
procedures given in the Streamlining Guide. Where interlaboratory
data were available, these data were used and the QC limits were
calculated as follows:
IPR lower recovery limit = average-2 x interlab sd
IPR upper recovery limit = average + 2 x interlab sd
IPR precision limit = 2 x sd
OPR and MS/MSD lower limit = average recovery -2.2 x interlab sd
OPR and MS/MSD upper limit = average recovery + 2.2 x interlab sd
Where interlaboratory data were not available but single-laboratory
data were available, the single-laboratory data were used and the QC
limits were calculated as follows:
IPR lower recovery limit = average -5.3 x interlab sd
IPR upper recovery limit = average + 5.3 x interlab sd
IPR precision limit = 3.0 x sd
OPR/MS/MSD lower recovery limit = average -6.0 x interlab sd
OPR/MS/MSD upper recovery limit = average + 6.0 x interlab sd
The multipliers include interlaboratory/single laboratory allowances
and are explained in the Streamlining Guide.
Where neither interlaboratory nor single-laboratory data were
available, default values of 100 percent recovery and 10 percent RSD
were used and the QC limits were calculated assuming single
laboratory data. This resulted in the following default values:
IPR lower recovery limit: 47%
IPR upper recovery limit: 153%
IPR precision limit: 30% RSD
OPR/MS/MSD lower recovery limit: 40%
OPR/MS/MSD upper recovery limit: 160%
Minimum levels were set to the level listed in the method (ML,
low end of the range, sensitivity, or other level, as noted) or, if
an MDL was available, were calculated by multiplying the MDL by 3.18
and rounding to the number nearest to 1, 2, or 5 x 10n, where n is
an integer.
2. On page 15046, the table titled, ``Standardized QC and QC
Acceptance Criteria for Methods in 40 CFR 141.23(k)(1)'' is corrected
to read as follows:
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Note to Table ``Standardized QC and QC Acceptance Criteria for Methods
in 40 CFR 141.23(k)(1)''
The QC acceptance criteria given in this table were developed
from data published in the following sources. For Method 200.7,
incorporated by reference into 40 CFR 141.23(k)(1), QC acceptance
criteria were developed using the regression equations in Table 9 at
the end of the method and published in Table 4 of Method 200.7 at 40
CFR 136, Appendix C. The concentration given in the Spike Conc
column is the concentration at which the QC acceptance criteria were
calculated. For calculating the precision criterion, the overall
standard deviation (S) was used (not the single-analyst standard
deviation (SR)). For the remaining 200-series metals methods, QC
acceptance criteria were developed from data in a table either at
the end of the method, as referenced in the table, or from
performance data published at the end of each method in Methods for
Chemical Analysis of Water and Wastes (MCAWW; EPA 600/4-79-020; NTIS
PB-123677). For methods other than Method 200.7 and the 200-series
metals methods, data published at the end of each method were used,
if available; otherwise default QC acceptance criteria, as described
below, were used.
The databases used to develop regression equations for Method
200.7 and the 200-series metals methods were not readily available.
Therefore, QC acceptance criteria were calculated using the
procedures given in the Streamlining Guide. Where interlaboratory
data were available, these data were used and the QC limits were
calculated as follows:
IPR lower recovery limit = average -2 x interlab sd
IPR upper recovery limit = average + 2 x interlab sd
IPR precision limit = 2 x sd
OPR and MS/MSD lower limit = average recovery -2.2 x interlab sd
OPR and MS/MSD upper limit = average recovery + 2.2 x interlab sd
Where interlaboratory data were not available but single-laboratory
data were available, the single-laboratory data were used and the QC
limits were calculated as follows:
IPR lower recovery limit = average -6.0 x interlab sd
IPR upper recovery limit = average + 6.0 x interlab sd
IPR precision limit = 3.0 x sd
OPR/MS/MSD lower recovery limit = average -6.0 x interlab sd
OPR/MS/MSD upper recovery limit = average + 6.0 x interlab sd
The multipliers include interlaboratory/single-laboratory allowances
and are explained in the Streamlining Guide.
Where neither interlaboratory nor single-laboratory data were
available, default values of 100 percent recovery and either 5 or 10
percent RSD were used and the QC limits were calculated assuming
single laboratory data. This resulted in the following default
values:
IPR lower recovery limit: 47%
IPR upper recovery limit: 153%
IPR precision limit: 30% RSD
OPR/MS/MSD lower recovery limit: 40%
OPR/MS/MSD upper recovery limit: 160%
Minimum levels were set by setting the ML to the low end of the
range listed in the method or, if an MDL was available, by
multiplying the MDL by 3.18 and rounding to the number nearest to 1,
2, or 5 x 10n, where n is an integer.
3. On page 15049, Table 141.40(n)(11) is corrected to read as
follows:
Table 141.40(n)(11)
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Other approved methods
------------------------------------------------------
Parameter/ Methodology Reference Standard
method EPA methods Other
18th ed.\1\
----------------------------------------------------------------------------------------------------------------
1. aldicarb
HPLC/Fl.............................. 531.1 ........................... 6610 ...........
2. aldicarb sulfone
HPLC/Fl.............................. 531.1 ........................... 6610 ...........
3. aldicarb sulfoxide
HPLC/Fl.............................. 531.1 ........................... 6610 ...........
4. aldrin
GC/ECD............................... 508.1 505, 508 ........... ...........
GC/MS................................ 525.2 ........................... ........... ...........
5. butachlor
GC/MS................................ 525.2 ........................... ........... ...........
GC/NPD............................... 507 ........................... ........... ...........
6. carbaryl
HPLC/Fl.............................. 531.1 ........................... 6610 ...........
7. dicamba
GC/ECD............................... 515.2 515.1 ........... ...........
HPLC................................. 555 ........................... ........... ...........
8. dieldrin
GC/ECD............................... 508.1 505, 508 ........... ...........
HPLC................................. 525.2 ........................... ........... ...........
9. 3-hydroxycarbofuran
HPLC/Fl.............................. 531.1 ........................... 6610 ...........
10. methomyl
HPLC/Fl.............................. 531.1 ........................... 6610 ...........
11. metolachlor
GC/ECD............................... 508.1 ........................... ........... ...........
GC/MS................................ 525.2 ........................... ........... ...........
GC/NPD............................... 507 ........................... ........... ...........
12. metribuzin
GC/ECD............................... 508.1 ........................... ........... ...........
GC/MS................................ 525.2 ........................... ........... ...........
GC/NPD............................... 507 ........................... ........... ...........
13. propachlor
GC/ECD............................... 508.1 508 ........... ...........
GC/MS................................ 525.2 ........................... ........... ...........
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Note: The following acronyms are used in this table:
ECD Electron Capture Detector
Fl Fluorescence
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GC Gas Chromatography
GC/MS Gas Chromatography/Mass Spectrometry
HPLC High Performance Liquid Chromatography
NPD Nitrogen Phosphorous Detector
UV Ultraviolet Detector
[FR Doc. 97-16735 Filed 6-25-97; 8:45 am]
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