[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)                                              
----------------------------------------------------------------------------------------------------------------
                                                                           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  ...........................  ...........  ...........
----------------------------------------------------------------------------------------------------------------
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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