[Federal Register Volume 60, Number 176 (Tuesday, September 12, 1995)]
[Proposed Rules]
[Pages 47325-47334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-22608]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 136

[FRL-5294-6]


A Public Meeting and Availability of Documents on Streamlining 
Approval of Analytical Methods at 40 CFR Part 136 and Flexibility in 
Existing Test Methods

AGENCY: U.S. Environmental Protection Agency (EPA).

ACTION: Notice of meeting and availability of documents.

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SUMMARY: The Office of Science and Technology within EPA's Office of 
Water is conducting a public meeting on approaches to streamlining the 
proposal and promulgation of analytical methods at 40 CFR Part 136 
under Section 304(h) of the Clean Water Act and increasing flexibility 
in existing 40 CFR Part 136 test methods. In this public meeting, EPA 
intends to discuss (1) procedures for streamlining the promulgation of 
new analytical methods under 40 CFR Part 136; (2) measures to provide 
increased flexibility for use of emerging technologies in analytical 
methods already promulgated at 40 CFR Part 136; (3) establishment of 
standardized quality control (QC) for analytical methods, including 
standardized procedures for development of QC acceptance criteria from 
single and interlaboratory data; (4) establishment of standardized data 
elements for reporting analytical results; (5) withdrawal of outdated 
methods; and (6) establishment of criteria by which the wastewater 
methods promulgated at 40 CFR Part 136 can be harmonized with other EPA 
program methods and with industry and association methods. The purpose 
of this notice is to provide information regarding the public meeting 
agenda, to make available documents concerning the Agency's 
streamlining effort, and to discuss the information and documents 
provided with this notice. This notice is not an advanced notice of 
proposed rulemaking, but is intended only to apprise persons of 
discussion topics at upcoming public meetings. Nothing in this document 
is intended to have regulatory effect or to initiate any rulemaking 
process. Where the document discusses existing regulatory 
interpretations, such interpretations are guidance only and not 
themselves binding on EPA, State regulatory agencies, or the public to 
the extent they are inconsistent with the underlying regulations.

DATES: The public meeting on streamlining will be held Thursday, 
September 28, 1995, from 9:00 a.m. to 5:30 p.m.

ADDRESSES: The public meeting on streamlining will be held at the 
Federal Building in Seattle, Washington. See Supplementary Information 
for further details.
    The documents made available with this notice can be obtained from 
Marion Thompson, Mail Code 4303, 401 M Street, S.W., Washington, DC 
20460. Phone: (202) 260-7117. Facsimile: (202) 260-7185.

FOR FURTHER INFORMATION CONTACT: Questions concerning this notice can 
be directed to Marion Thompson by phone at (202) 260-7117 or by 
facsimile at (202) 260-7185.

SUPPLEMENTARY INFORMATION: Arrangements for the public meeting are 
being coordinated by DynCorp EENSP. For information on registration, 
contact Cindy Simbanin, 300 N. Lee Street, Suite 500, Alexandria, VA 
22314. Phone: (703) 519-1386. Facsimile: (703) 684-0610. Space is 
limited and reservations are being taken on a first come, first served 
basis. No fees will be charged to attend. Hotel reservations may be 
made by contacting the Crowne Plaza Hotel in Seattle at (800) 521-2762. 
Guest rates are $83 single and $106 double occupancy, including tax. 
Reservations must be made by 9/8/95, and you must specify that you are 
attending the EPA Workshop to qualify for the group rate. 
Accommodations are limited, so please make your reservations early.

I. Background

    Section 304(h) of the Clean Water Act (CWA) requires the EPA 
Administrator to promulgate guidelines establishing test procedures for 
data gathering and monitoring under the Act. These test procedures 
(analytical methods) are promulgated at 40 CFR Part 136. EPA uses these 
analytical methods to support development of effluent guidelines 
promulgated at 40 CFR Parts 400-499. These procedures we also used to 
establish compliance with National Pollutant Discharge Elimination 
System 

[[Page 47326]]
(NPDES) permits and for other purposes.

A. 40 CFR Part 136 Methods

    Until April of 1995, proposal and promulgation of analytical 
methods for wastewater at 40 CFR Part 136 had been the responsibility 
of EPA's Office of Research and Development (ORD), specifically, the 
Environmental Monitoring Systems Laboratory in Cincinnati, Ohio (EMSL-
Ci). In April of 1995, EPA restructured its research laboratories and 
transferred responsibility for proposal and promulgation of analytical 
methods for wastewater to the Engineering and Analysis Division (EAD) 
within the Office of Water's (OW's) Office of Science and Technology 
(OST).
    One objective in implementing transfer of the 304(h) program was to 
better serve the needs of the regulated community, State and Regional 
permitting authorities, and environmental laboratories, by centralizing 
the methods overall responsibility for effluent guidelines methods and 
associated compliance monitoring methods into a single office. This 
centralization of responsibility should allow EPA to better respond to 
the needs of these communities by expediting the current method 
modification and approval process. Specific goals for streamlining the 
program are to:
    (1) Decrease the time and Agency resources required to approve new 
analytical techniques and improved methods,
    (2) Provide for an increase in the number of methods that are 
approved for use each year,
    (3) Increase participation of outside organizations in the method 
development process, and
    (4) Improve overall program quality.
    In order to achieve these goals, EPA is considering development of 
a 304(h) program framework that is based on the following key elements:
     Increased flexibility to modify approved methods,
     Standardized QA/QC protocols to be required for all new 
methods,
     Standardized procedures for generating QC acceptance 
criteria,
     Standardized procedures for validating methods at minimal 
expense,
     A standardized method format,
     Standardized procedures for submitting methods to EPA for 
approval,
     Standardized processes for reviewing and approving 
methods, and
     Increased stakeholder involvement in 304(h) program 
implementation.

B. Public Meetings

    EPA plans to conduct at least three public meetings, the public 
meeting announced in this notice and two others to be announced 
separately, to solicit input and recommendations concerning the 304(h) 
streamlining initiative. In addition, EPA is soliciting support and 
expertise from each of the groups that have developed methods already 
approved for use under the 304(h) program. These groups include the 
AOAC-International (formerly the Association of Official Analytical 
Chemists), the American Society for Testing and Materials (ASTM), the 
American Public Health Association (APHA), the Water Environment 
Federation (WEF), the U.S. Geological Survey (USGS), and the American 
Water Works Association (AWWA). Many of these groups can offer valuable 
insight concerning problems with the current program and recommended 
areas of improvement. Also, some of these groups have developed or are 
developing standardized procedures for the areas listed above. In these 
instances, EPA plans to build upon the experience and efforts of those 
organizations. For example, the method validation procedures described 
later in this notice are based on the standardized method validation 
protocols developed by AOAC-International and ASTM and are adapted as 
necessary to meet EPA's regulatory objectives.

C. Increased Flexibility in the 304(h) Program
    In developing its preliminary plans for improvement of the 304(h) 
program, EPA concluded that the success of the program would depend on 
its ability to reflect the latest advances in analytical technology. 
This, in turn, would require that the program be efficient and flexible 
enough to encourage the development of new methods and technology by 
organizations outside of EPA. Specifically, the program must provide:
     A well-defined QC/QA program that is stringent enough to 
meet compliance monitoring objectives associated with the program but 
flexible enough to be applied to a wide variety of analytical 
procedures,
     A well-defined system of classifying new techniques as 
either new methods or as modifications to existing methods,
     A flexible framework in which already approved methods can 
be modified, and
     The flexibility to modify processes for submitting new 
methods based on lessons learned.
    Advantages of increased program flexibility are expected to be 
shared widely by EPA, by purveyors of new technology, and by 
permittees, permit writers, and analytical laboratories. In addition, 
this inherent method flexibility, along with a well-defined program for 
developing and approving new methods, will provide research 
laboratories, instrument vendors, and equipment manufacturers with 
incentives for developing new analytical techniques. This, in turn, 
will provide permittees and permit writers with greater flexibility in 
selecting analytical methods that yield improved performance in 
specific discharge situations.
    Finally, a more flexible program is consistent with this 
Administration's Environmental Technology Initiative. The initiative, 
which was announced by President Clinton in February 1993, is intended 
to accelerate environmental technological innovation as a means of 
strengthening America's economy and creating jobs while enhancing 
environmental protection. EPA believes that the incentives provided by 
a more flexible program will spur the development of new technologies, 
and with it new jobs. In addition, EPA anticipates that the use of new 
technologies may lower the cost of environmental measurements, thereby 
reducing costs of environmental compliance for industries and 
municipalities.
    In seeking increased program flexibility, EPA has sought to develop 
a strategy that balances the advantages described above against 
concerns that results produced with new technologies may not be 
equivalent to results produced by the approved 40 CFR Part 136 methods. 
The core of this strategy is a well-defined QA/QC program that can 
apply to all approved methods and method modifications.
    The remainder of this notice outlines a framework in which the key 
elements listed above can be implemented to meet EPA's streamlining 
objectives. This framework will be discussed at the public meetings on 
streamlining. Section II describes OST's vision for increased 
flexibility within the 304(h) program itself and for increased 
flexibility within specific methods approved under the program. Section 
II also describes the standardized QC framework on which this program 
and method flexibility is based and outlines requirements necessary to 
document equivalency of alternate techniques used in the program. 
Section III describes procedures that can be used to develop acceptance 
criteria for the standardized QC tests outlined in 

[[Page 47327]]
Section II. Section IV describes standardized procedures for submitting 
new methods, including a standardized format for documenting new 
methods, standardized procedures for validating new methods, and 
standardized procedures for submitting validated methods to EPA for 
approval.

II. Method Flexibility

    On October 26, 1984, EPA addressed the flexibility allowed in the 
wastewater methods with the promulgation of a major set of methods at 
40 CFR Part 136 Appendix A for determination of organic analytes (49 FR 
43234). In that promulgation, EPA stated that flexibility would be 
allowed in certain parts of the analytical methods, provided that 
equivalency could be demonstrated. This notice describes a methods 
system in which greater flexibility is allowed.

A. Interpretations of Flexibility

    EPA has received several requests for interpretation of the 
flexibility allowed by the 40 CFR Part 136 methods, and EPA's Office of 
Research and Development (ORD) and Office of Science and Technology 
(OST) have provided technical interpretations of these requests. 
Interpretations made to date are provided in a document titled 
Technical Interpretation of Method Flexibility that is made available 
with this notice. These interpretations further clarify the flexibility 
of the 40 CFR Part 136 methods given in the 1984 final rule (49 FR 
43234).

B. Alternate Methods

    The current means by which organizations may seek approval of 
alternate methods is described at 40 CFR Sections 136.4 and 136.5. If 
an alternate method is to be applied to a specific discharge, section 
136.4 requires the person submitting the request to file a limited 
approval application with the Administrator of the EPA Region in which 
the discharge occurs. If permission is sought to use the alternate 
method for nationwide use, a nationwide approval application must be 
filed with the Director of EMSL-Ci. In most instances, Regional 
Administrators have deferred decisions concerning limited approval to 
the Director of EMSL-Ci. To support its approval process, EMSL-Ci 
developed extensive requirements for the data needed to demonstrate 
that an alternate method produces results that are equal to or better 
than results produced by the approved method. This alternate test 
procedure (ATP) process has worked well for persons willing to invest 
the resources required. EPA seeks a public discussion of whether the 
ATP process should be continued, particularly in the context of the 
adoption of the streamlining process contemplated by this notice.
    In contrast to continuing the ATP process, EPA has received 
numerous comments at its technical symposia and in other venues that 
the ATP process is cumbersome, and that the data gathering required is 
much more extensive than is necessary to demonstrate that a simple 
method modification does not materially affect the results produced by 
that method. Against this view, many permitting agencies interpret the 
words in an analytical method very literally and allow no changes 
whatsoever. In many cases, narrow interpretation may be justified, in 
that the permitting authority may have experienced situations in which 
certain unscrupulous dischargers or laboratories have taken shortcuts 
that ultimately compromised the analytical results produced. If this 
compromise results in compliance with a permit limit when use of the 
approved, unmodified method would result in noncompliance, a narrow, 
restrictive interpretation would be justified.
    EPA now intends to describe the conditions under which minor method 
modifications would be allowed and would be considered within the scope 
of a method. One approach to this issue is described below and will be 
discussed during the public meetings announced in this notice. There 
may be other approaches. Therefore, EPA seeks input from the public, 
particularly from the regulating and regulated communities, as to the 
workable set of conditions under which method modifications should be 
allowed.

C. Front-End Method Modifications

    For purposes of the public meetings, EPA plans to consider changes 
to all but the determinative step in an analytical method as being 
within the scope of that method. The determinative step is the 
physical/chemical process by which the actual measurement is made. For 
most methods, the determinative step is an instrumental determination. 
Titration, colorimetry, inductively coupled plasma atomic emission 
spectroscopy (ICP/AES), high resolution gas chromatography combined 
with high resolution mass spectrometry (HRGC/HRMS), and reading a color 
change in an immunoassay are all examples of the determinative step.
    All ``front-end'' devices and processes employed prior to the 
determinative step, including sampling, sample extraction/digestion, 
sample cleanup, and sample introduction, are not considered to be part 
of the determinative step. In addition, changes to data processing and 
other techniques that occur after the determinative technique rarely 
impact data reliability.
    One objective of providing flexibility to modify approved methods 
is intended to allow laboratories a means by which to reduce the 
generation of laboratory wastes without having to undergo elaborate 
comparison studies and a time-consuming approval process. The front-end 
flexibility described in this notice is based on an in-house laboratory 
comparison of QC sample results generated using the modified method. 
Once the laboratory has successfully demonstrated that the modified 
method is comparable to the approved 40 CFR Part 136 method (Reference 
Method), the laboratory would be able to implement the changes 
immediately. Section II.E. of this notice outlines procedures that may 
be required to demonstrate method comparability.
1. Examples of Determinative Techniques
    As described above, a method that uses a different determinative 
technique would be either a modification of another, existing, EPA-
approved method or is a new method. The factors to be considered in 
establishing that the determinative technique is the same as that in an 
existing method are (1) the physical/chemical nature of the measurement 
process and (2) the specificity of the measurement for the analyte(s) 
of interest. If either or both of these factors are different from an 
existing method for the analyte(s) of interest, the determinative step 
is not the same and the procedure would not be considered to be a new 
method.
    For example, the use of a horizontal torch in an ICP is not a 
different determinative technique because neither the physical/chemical 
process nor the specificity of the measurement is changed. Similarly, 
the use of a magnetic sector in place of a quadrupole in a low 
resolution mass spectrometer (LRMS) is not a change in the 
determinative technique because neither the physical/chemical process 
nor the specificity of measurement is changed. On the other hand, the 
addition of a mass spectrometer to the ICP results would be a change in 
both the physical/chemical process and the specificity, and use of a 
high resolution mass spectrometer in place of the LRMS results in a 
change in specificity, even though the physical/chemical nature of the 
process is not changed.
    Further, and as one of EPA's internal reviewers has pointed out, 
the determinative technique may be the 

[[Page 47328]]
least variable part of the entire analytical process. Therefore, 
although this notice provides one approach to flexibility in which the 
determinative process would be fixed, EPA seeks to discuss how this 
flexibility could be quantified and controlled to allow use of 
alternate determinative techniques without compromising the specificity 
of a method for the analyte(s) of interest and without making the 
flexibility so broad that the method protocol becomes meaningless.
2. List of Candidate Front-End Techniques
    This use of the physical/chemical nature and specificity of the 
determinative technique to describe fundamental method changes would 
result in the conclusion that all analytical processes that occur prior 
to the determinative technique and that do not adversely affect method 
performance could be considered within the scope of a method. To 
facilitate an understanding of such front-end techniques that could be 
considered within the scope of existing 40 CFR Part 136 methods, EPA 
has compiled a list titled Front-end Techniques that are Candidates for 
Method Modification Under EPA's Method Flexibility Overture. This list, 
which is based on a review of methods promulgated at 40 CFR Part 136 
and on discussions of some of these techniques at technical symposia 
and with instrument vendors and other suppliers of analytical 
equipment, is made available with this notice. EPA emphasizes that this 
would not be a list of approved techniques, nor would this list be all-
inclusive. The list is merely intended to provide examples of the types 
of procedural modifications that may fall within the flexibility of 
approved methods. Presently, substitution of these techniques in a 
method approved for use under 40 CFR Part 136 is allowed only when 
these techniques are listed in the approved method or under the 
conditions described in the document titled Technical Interpretation of 
Method Flexibility that is also made available with this notice.
3. Cautions That All Techniques May Not Produce Equivalent Results
    EPA wishes to emphasize that not all techniques may produce results 
equivalent to the techniques employed in the 40 CFR Part 136 methods. 
This is particularly true for ``method-defined'' analytes. A method-
defined analyte is one in which the analytical result obtained depends 
totally on how the measurement is made. Therefore, changes to specific 
analytical protocols have the potential of changing the numerical value 
of the results for a given sample. For example, the conventional 
pollutant ``oil and grease'' (40 CFR 401.16) is defined by the exact 
procedure used. In attempting to find a solvent to replace Freon-113 
for the determination of oil and grease, EPA has found that no solvent 
produces results exactly equivalent to the results produced by Freon-
113 on the range of environmental samples tested. Extreme care must 
therefore be exercised in making changes to the analytical techniques 
used in the determination of these method-defined analytes.
    Even for analytes that are not method-defined, differing analytical 
techniques can produce varying results. Examples of techniques that 
have come to EPA's attention are differences produced by separatory 
funnel and continuous liquid-liquid extractors in the extraction of 
phenolic compounds by EPA Method 625 and with other methods in which 
phenolic compounds are determined. Similarly, EPA has observed 
differences produced by separatory funnel and stir-bar extraction 
techniques for certain pulp mill wastewaters using Method 1653 and 
differences produced by batch versus column adsorption techniques for 
certain pulp mill wastewaters using Method 1650.
    One possible solution to this problem would be to require that each 
modified method be used to analyze a matrix spike/matrix spike 
duplicate pair on each dissimilar matrix. Another possible solution is 
to require testing of each modified method on each and every specific 
discharge to which the modified method is to be applied. EPA employed 
this philosophy in the development of Method 1664 for the determination 
of oil and grease. Method 1664 would require demonstration of 
equivalency using analytical standards spiked into reagent water and 
testing of the specific discharge unless the concentration of oil and 
grease in the discharge is not detectable.
    Finally, it has been suggested that it is necessary to define 
methods by the extraction/digestion procedure and the determinative 
step in order to ensure that results produced through a modified method 
are truly comparable. For example, it has been suggested that without 
this stricter definition of methods, total metals digestions could be 
omitted and still yield acceptable recoveries of metals from spiked 
samples. One possible solution to this problem would be to modify the 
QC requirements to require spiking of various forms of target analytes, 
as appropriate to the method. For example, laboratories testing for 
total metals would be required to include organic, inorganic, highly 
soluble, and relatively insoluble species of the metals of interest in 
their spike solutions when demonstrating method equivalency. Another 
possible solution would be to simply limit the flexibility outlined 
above and in the document entitled Front-end Techniques that are 
Candidates for Method Modification Under EPA's Method Flexibility 
Overture by omitting all techniques associated with sample extraction 
or digestion.

D. Standardized Quality Control

    In order to establish that a front-end change will not degrade 
method performance, a reference against which the change is made would 
be needed. For the purposes of the public meetings, the reference would 
be the method promulgated at 40 CFR Part 136. The definitive test 
criteria against which performance of the front-end modification would 
be assessed would be the QC acceptance criteria in the promulgated 
method. For those methods that do not contain QC acceptance criteria, 
these criteria would be developed using performance data in the 
promulgated 40 CFR Part 136 method. See the discussion in Section III 
of this notice on how EPA would establish these criteria.
    The QC acceptance criteria would be based on the standardized 
quality control (QC) described below. This standardized QC includes QC 
tests that can be used to demonstrate that a front-end change would not 
adversely affect method performance. EPA would like to apply this 
standardized QC to all methods to be proposed at 40 CFR Part 136 in the 
future. EPA would also like to apply this standardized QC to all 
applicable methods and analytes that are already approved for use at 40 
CFR Part 136. Applicability includes all chemical analytical methods, 
and, with some modification, many of the radiological methods and 
physical methods. EPA is in the process of developing corresponding QC 
requirements for determining the equivalence of toxicity testing 
procedures and may include this corresponding QC in a subsequent notice 
or proposal.
1. Standardized QC in the 40 CFR Part 136 Methods
    The standardized QC program envisioned by EPA would be based on the 
QC program detailed in Section 8 of each method published at 40 CFR 
136, Appendix A. For the purpose of providing a solid foundation on 
which to build the method and program 

[[Page 47329]]
flexibility described in this notice, EPA has updated and expanded the 
standardized QC that is detailed in these methods to ensure reliable 
measurements. The expanded and updated standardized QC that EPA plans 
to use would be as follows:
     Initial calibration--a minimum of five concentrations of 
analytical standards for the analyte(s) of interest, one near the 
method detection limit (MDL; 40 CFR 136, Appendix B), and one near the 
upper end of the calibration range. The nature of the calibration 
function allowable is specified in the method or, in the absence of 
such specifications, can be developed from performance data using the 
procedures outlined in Section III of this notice. Examples of the 
calibration function include: linear through the origin, linear not 
through the origin, or quadratic through or not through the origin. 
Calibration functions higher than second order (quadratic) would not be 
allowed. Limits on the calibration function are also specified in the 
method or, in the absence of such specifications, can be developed from 
performance data. For example, if linearity through the origin is used, 
some limit on the linear fit should be stated. In the Appendix A 
methods, this limit is specified as the percent relative standard 
deviation of the response factor or calibration factor. Laboratories 
seeking to exercise the front-end method flexibility described in this 
notice would be required to meet all initial calibration acceptance 
criteria when using the modified technique.
     Calibration verification--periodic verification that 
instrument performance has not changed significantly. This verification 
is based on time (e.g., a working day or 12-hour shift) or on the 
number of samples analyzed (e.g., after every 10th sample). QC 
acceptance criteria are given in the approved method or can be 
developed for each analyte using the procedures outlined in Section III 
of this notice. Laboratories seeking to exercise the front-end method 
flexibility described in this notice would be required to meet these QC 
acceptance criteria when using alternate front-end techniques. Most 
methods approved under this program specify corrective action that the 
analyst is to take when calibration is not verified, e.g., that all 
samples analyzed since the last verified calibration must be 
reanalyzed, or that the surrogate and matrix spike recoveries should be 
used to determine if results for a given sample are valid. Under the 
standardized QC program envisioned by EPA, this required action to 
would be extended to all methods already approved for use at 40 CFR 
Part 136 and to all new methods submitted for approval.
     Initial demonstration of laboratory capability--analysis 
of four reagent water samples spiked with the analyte(s) of interest 
and carried through the entire analytical process. This test is 
performed by the laboratory before it utilizes the method for analysis 
of actual field samples. In the 1600 series methods, this test is 
termed the ``initial precision and recovery'' (IPR) test. In other 
venues, it has been termed the ``start-up'' test. All four reagent 
water samples used in the test are spiked with the same solution, but 
the concentration of target analytes in the spike solution may vary 
between one and five times the lowest concentration used to establish 
the initial calibration curve. Laboratory performance is assessed in 
terms of the average percent recovery and the standard deviation of 
recovery. QC acceptance criteria for each analyte and consequences of 
failing the IPR test are given in the 40 CFR 136, Appendix A methods. 
For other methods, the procedures outlined in Section III of this 
notice can be used to develop QC acceptance criteria. Under the 
standardized QC program envisioned by EPA, corrective action required 
for failing to meet these criteria would be to correct the problem and 
repeat the test prior to the analysis of field samples. Laboratories 
seeking to exercise the front-end flexibility described in this notice 
would be required to produce acceptable IPR test results using the 
modified method technique.
     Analysis of blanks--either periodically or with each 
sample batch. The period or batch size is defined in each method. QC 
acceptance criteria are given in each method or can be developed for 
the concentration or amount of analyte allowed in the blank. Under the 
standardized QC program envisioned by EPA, the consequence of failing 
to meet the acceptance criteria will be to identify and eliminate the 
source of contamination and reanalyze the sample batch with which the 
blank is associated. Laboratories seeking to exercise the front-end 
method flexibility outlined in this notice must be capable of producing 
acceptable blanks when using the alternate techniques.
     Analysis of a matrix spike (MS) and matrix spike duplicate 
(MSD)--the analytes of interest are spiked into splits of an actual 
field sample, and the recovery of the analytes is used to assess method 
performance on that sample matrix. (For isotope dilution analyses, the 
MS/MSD analyses are not required because every sample is spiked.) QC 
acceptance criteria for spike recovery and for the relative percent 
difference (RPD) in results between the MS/MSD pair are given in the 
methods. In the absence of such specifications, recovery and RPD 
acceptance criteria can be developed from performance data using the 
procedures outlined in Section III of this notice. Unless otherwise 
stated in the approved method, EPA envisions that the normal 
consequence of failing the MS/MSD test will be to reanalyze the sample 
batch with which the MS/MSD are associated. Laboratories seeking to 
exercise the front-end flexibility described in this notice would be 
required to analyze an MS/MSD pair on each new matrix. If results of 
these MS/MSD analyses fail to meet the acceptance criteria, the 
laboratory would be required to conduct more extensive studies of the 
modified method on that matrix.
     Ongoing demonstration of laboratory capability--analysis 
of a single reagent water sample spiked with the analyte(s) of 
interest. This sample is carried through the entire analytical process 
to demonstrate that the laboratory is in control and to allow 
separation of laboratory performance from method performance on the 
sample matrix. In the 40 CFR 136, Appendix A methods, this sample is 
referred to as a ``quality control check sample.'' In other venues, 
this analysis has been termed the ``ongoing precision and recovery'' 
(OPR) analysis, the ``laboratory control sample'' (LCS), and the 
``laboratory-fortified blank'' (LFB). QC acceptance criteria for each 
analyte in this sample are given the approved method, or in the absence 
of such criteria, can be developed from performance data using the 
procedures described in Section III of this document. Unless otherwise 
stated in the approved method, EPA envisions that the consequence of 
failing the OPR test will be to reanalyze the sample batch with which 
the OPR is associated.
     Method detection limit (MDL)--nearly all of the 40 CFR 
136, Appendix A methods contain MDLs, although few of the methods 
explicitly require laboratories to demonstrate their ability to achieve 
these MDLs. Methods recently published by OST and by ORD, however, have 
required laboratories to demonstrate their ability to achieve specified 
MDL objectives. Under the standardized QC program envisioned by EPA, 
MDLs would be used as an indicator of method performance. MDLs, or the 
embodiment of some other detection limit concept, should be developed 
for each analyte in each method, and each laboratory that intends to 
practice a method should be 

[[Page 47330]]
required to demonstrate that the MDL(s) or equivalent detection limit 
concept can be achieved prior to practice of the method. As envisioned 
by EPA in the system contemplated by this notice, this requirement 
would apply to the analytes of interest only.
     Analysis of a reference sample from a source external to 
the laboratory--the most common reference sample is a Standard 
Reference Material from the National Institute of Standards and 
Technology (NIST). The reference sample and the period for its use are 
specified in each method. EPA is considering setting acceptance 
criteria for standard reference materials to be within some percentage 
of the true value based on the variability of measurement for that 
analyte. One possible indicator of that variability is the relative 
standard deviation calculation for the initial precision and recovery 
samples. Corrective action to be taken when the acceptance criteria are 
not met should involve identifying the samples affected, determining 
the amount of the effect, and if the effect is significant, determining 
the impact of the effect on the environmental samples analyzed and 
advising the affected parties.
2. Standardized QC in Other Method-Developing Organizations
    During the last several years, EPA has worked closely with ASTM 
toward the development of standardized QC for incorporation into ASTM 
methods. One product of this effort is a draft document entitled 
Standard Practice for Writing Quality Control Specifications for Test 
Methods for Organic Constituents, which has been approved by the ASTM 
Committee D-19 on Water. This document, which is made available with 
this notice, requires standardized QC in all future editions of organic 
methods and describes how criteria are to be calculated from the 
results of an interlaboratory method validation study. The main 
difference between the QC requirements outlined in this document and 
those produced today is the lack of an ASTM requirement to determine 
MDLs.
    EPA has also worked closely with the Environmental Quality 
Committee of AOAC-International to standardize and collaboratively test 
methods that contain comparable QC requirements and performance-based 
QC criteria. More recently, EPA has begun working with the American 
Public Health Association, American Water Works Association, and Water 
Environment Federation toward standardization of QC to be used for 
methods published in Standard Methods for the Examination of Water and 
Wastewater and promulgated at 40 CFR Part 136. Similarly, EPA has begun 
working more closely the U.S. Geological Survey (USGS) toward 
standardization of QC for USGS methods promulgated at 40 CFR Part 136.
    EPA plans to continue efforts with these organizations to advance 
the universal adoption of standardized QC that would facilitate rapid 
proposal of methods produced by these organizations at 40 CFR Part 136. 
Further, if the methods developed by these organizations meet or exceed 
the needs of the Agency, EPA would rely on these organizations as 
primary method developers and could focus its own efforts on 
specialized methods or on esoteric methods needed to support regulation 
development or compliance monitoring.

E. Requirements for Documenting Front-End Method Equivalency

    Under the program envisioned by EPA, flexibility in existing 
methods will apply to any change in one or more front-end devices and 
processes as long as these changes do not adversely affect method 
performance. In exercising this flexibility, laboratories will be 
required to demonstrate and document that the changes implemented will 
produce results that are comparable to or better than those produced by 
the Reference Method.
    Demonstration that the method will meet or exceed the performance 
of the Reference Method and/or regulatory goals requires laboratories 
to perform the applicable QC tests outlined in Section II.D.1 of this 
notice and meet the applicable QC acceptance criteria associated with 
each test. Laboratories that exercise the flexibility offered by this 
program will be required to maintain all equivalency documentation on 
file and submit it to their clients (data users) upon request. 
Permittees that exercise the flexibility offered by this program will 
be responsible for ensuring that equivalency has been demonstrated by 
their in-house or contract laboratories and for ensuring that 
documentation can be provided to permitting authorities upon request.
    At a minimum, documentation of method equivalency will include all 
raw results and summary data generated for each of the QC elements 
required. Alternatively, laboratories, permittees, or permitting 
authorities may elect to utilize the checklist provided and described 
in a document titled Methods Considered Within the Scope of Existing 
Wastewater Methods Under the EMMC Performance-based Methods System 
(EMMC PBMS Guidance), made available with this notice.
    Minimum data elements that EPA believes must be retained on file 
(and made available on request) to demonstrate equivalency are as 
follows.
    1. The organization and method number for the modified 40 CFR Part 
136 method (Reference Method) used for the measurement.
    2. A detailed narrative discussing the modification(s) to the 
Reference Method. This narrative should provide (1) a detailed 
description of the changes made to the Reference Method, (2) the 
reasons for the change, (3) the supporting logic behind the technical 
approach to the change, and (4) the result of the change. The narrative 
should be written by an analytical chemist and written in terms that 
another analytical chemist can understand.
    3. A summary level report or data reporting forms listing the 
pollutants, along with their CAS Registry numbers, for which the 
modifications were made.
    4. A summary of all quality control results required by the 
Reference Method. These results include, but are not limited to, the 
following:
     Method-specific instrument tuning.
     Calibration.
     Calibration verification.
     Initial precision and recovery.
     Ongoing precision and recovery.
     Matrix spike and matrix spike duplicate results.
     Surrogate recoveries.
     Internal standard recoveries.
     Labeled compound recoveries.
     Method of standard additions.
     Spectral interference checks.
     Serial dilutions.
     Blank results.
     Quality control charts and limits.
     MDL study results.
    Specific QC results vary according to the Reference Method and the 
instrument used in the determinative step. For example, labeled 
compound recoveries are associated only with methods that are based on 
isotope-dilution techniques, and spectral interference checks are 
typically associated with ICP-AES analyses.
    5. Raw data that will allow an independent reviewer to verify each 
determination and calculation performed by the laboratory.
    This verification should consist of tracing the instrument output 
(peak height, area, emission intensity, or other signal intensity) to 
the final result reported. Raw data are method and instrument specific 
and may include, but are not limited to the following:
     Sample numbers or other identifiers used by the both the 
permittee and the laboratory. 

[[Page 47331]]

     Sample preparation (extraction/digestion) dates.
     Analysis dates and times.
     Sequence of analyses or run logs.
     Sample weight or volume.
     Extract volume prior to each cleanup step.
     Extract volume after each cleanup step.
     Final extract volume prior to injection.
     Digestion volume.
     Titration volume.
     Percent solids or percent moisture.
     Matrix modifiers.
     Dilution data, differentiating between dilution of a 
sample and dilution of an extract or digestate.
     Instrument (make, model, revision, modifications) and 
operating conditions.
     Sample introduction system (ultrasonic nebulizer, hydride 
generator, flow injection system, etc.).
     Column conditions (manufacturer, length and diameter, 
stationary phase, solid support, film thickness, chelating or ion 
exchange resin, etc.).
     Analysis conditions (char/ashing temperatures, temperature 
programs, incident rf power, flow rates, plasma viewing height, etc.).
     Detectors (type, wavelength, slit, analytical mass 
monitored, etc.).
     Chromatograms, ion current profiles, bar graph spectra, 
library search results.
     Background correction scheme.
     Quantitation reports, data system outputs, and other data 
to link the raw data to the results reported. (Where these data are 
edited manually, explanations of why manual intervention was necessary 
must be included).
     Direct instrument readouts; i.e., strip charts, mass 
spectra, printer tapes, etc., and other data to support the final 
results.
     Laboratory bench sheets and copies of all pertinent 
logbook pages for all sample preparation and cleanup steps, and for all 
other parts of the determination.
    The raw data required should be provided for all calibrations, 
verifications, blanks, matrix spikes and duplicates, and other QC 
analyses required by the Reference Method as well as any field samples 
analyzed by the method. Data should be organized so that an analytical 
chemist can clearly understand how the analyses were performed.
    6. Example calculations that will allow the data reviewer to 
determine how the laboratory used the raw data to arrive at the final 
results.
    Useful examples include both detected compounds and undetected 
compounds. If the laboratory or the method employs a standardized 
reporting level for undetected compounds, this should be made clear in 
the example, as should adjustments for sample volume, dry weight 
(solids only), etc.
    7. For GC/MS and other instruments involving data systems, the 
permittee should be prepared to submit raw data on magnetic tape or 
disk, upon request by the regulatory authority.
    8. The names, titles, addresses, and telephone numbers of the 
analysts who performed the analyses and of the quality control officer 
who will verify the analyses.
    If data are collected by a contract laboratory, the permittee will 
be responsible for ensuring that all of the requirements in the methods 
are met by the contract laboratory and that all data listed above are 
provided.

III. Development of QC Acceptance Criteria

    Few of methods promulgated at 40 CFR Part 136 contain QC acceptance 
criteria for all of the standardized QC elements outlined in this 
notice. (The notable exceptions are the methods published at 40 CFR 
136, Appendix A.) As described above, however, QC acceptance criteria 
are the principle means by which a front-end method modification can be 
judged to provide results equivalent to or better than results produced 
by the Reference Method. For those methods that do not contain QC 
acceptance criteria, EPA plans to employ one of three sources of data 
for developing these criteria. These sources are (1) interlaboratory 
study data contained in the promulgated 40 CFR Part 136 analytical 
method, if available, (2) water supply (WS) and water pollution (WP) 
study data, or (3) single-laboratory data contained in the promulgated 
analytical method. In explanation, WS and WP study data result from 
laboratory performance evaluations conducted periodically by EPA's 
National Environmental Research Laboratory at Cincinnati (NERL-Ci, 
formerly EMSL-Ci). By following the statistical techniques described 
below and detailed in the accompanying supporting document, these WS 
and WP data, or the performance data contained in an existing 
analytical method promulgated at 40 CFR Part 136, can be used to 
establish QC acceptance criteria.
    As of the date of publishing this notice, EPA has not developed a 
means for developing QC acceptance criteria for a method for which EPA 
has neither WS/WP study data nor performance data, and until such means 
are developed, EPA will not allow modification of promulgated 40 CFR 
Part 136 methods for which these data are not available. Although EPA 
has not surveyed all methods promulgated at 40 CFR Part 136, the Agency 
believes that the number of methods that (1) do not contain QC 
acceptance criteria, (2) are not covered by the WS/WP studies, or (3) 
do not contain performance data, is small. EPA seeks a public 
discussion of how to establish QC acceptance criteria when data on 
which to base these criteria are not available.

A. Development of QC Acceptance Criteria From Interlaboratory Study 
Data
    ASTM and AOAC-International have published extensive literature on 
the statistical treatment of data for interlaboratory collaborative 
testing of analytical methods, including ``ASTM D-2777'' and Guidelines 
for Collaborative Study Procedure to Validate Characteristics of a 
Method of Analysis, JAOAC 72 No. 4, 1989. EPA's Office of Research and 
Development (ORD) and Office of Science and Technology (OST) have used 
the ASTM and AOAC-International statistical procedures to produce QC 
acceptance criteria for analytical methods published by their offices. 
The specific embodiment of the procedures as used by OST are given in 
an OST document titled Development of QC Acceptance Criteria, made 
available with this notice. EPA plans to work with AOAC-International 
and ASTM to conform these procedures as much as is practicable.

B. Development of QC Acceptance Criteria From WS/WP Study Data

    EPA is considering use of WS/WP study data to establish QC 
acceptance criteria for an analytical method for which these criteria 
have not been developed. The procedures used will be the same or 
similar to those in ASTM D-2777 and detailed in the Development of QC 
Acceptance Criteria document referenced above. EPA envisions that this 
development will be conducted internally by EPA on an as-needed basis 
for methods, and that the acceptance criteria will then be proposed for 
promulgation at 40 CFR Part 136.

C. Development of QC Acceptance Criteria From Method Performance Data

    Although few of the methods promulgated at 40 CFR Part 136 have QC 
acceptance criteria, most of these methods do contain performance data. 
Usually, these data reflect method performance in a single laboratory. 
Using the procedure given in the 

[[Page 47332]]
document titled Development of QC Acceptance Criteria, these 
performance data can be used to establish QC performance criteria. 
Basically, this procedure uses the recovery and standard deviation of 
recovery to establish the QC acceptance criteria, with an additional 
allowance for interlaboratory variability where applicable. Exact 
details of these procedures are given in the Development of QC 
Acceptance Criteria document that is made available with this notice.

IV. Submission of New Methods

    The process EPA envisions for submission of new methods encompasses 
the elements described in this notice. These elements are as follows:
     The method would be written using the guidelines and 
format described in Section IV.A.,
     The method would incorporate the standardized QC elements 
described in Section II.E.,
     QC acceptance criteria would be included in the method as 
described in Section III, and
     The method would be validated for single-use, single-
industry use, or nationwide use, as described in Section IV.B.

A. Standardized Method Format

    Made available with this notice is a document titled Guidelines and 
Format for Methods to be Proposed at 40 CFR Part 136. This document is 
a further development of the Guidelines and Format for EMSL-Cincinnati 
Methods (EPA-600/8-83-020) produced by EMSL-Ci in 1983. In turn, the 
Guidelines and Format for EMSL-Ci Methods was based on the ASTM's Form 
and Style for ASTM Standards, 5th ed., June 1980 (13-000001-80). The 
Guidelines and Format for Methods to be Proposed at 40 CFR Part 136 
incorporates several important aspects of the information presented in 
this notice. It also incorporates the analytical methods format 
prescribed by EPA's Environmental Monitoring Management Council (EMMC). 
The EMMC format is directed at standardizing all Agency analytical 
methods.
    For new methods submitted under the program discussed in this 
notice, a guideline and format from another organization may be used 
provided it is standardized and contains the same elements specified in 
this document. For example, the method format documents from the APHA, 
AWWA, and WEF for Standard Methods for Examination of Water and 
Wastewater, and from ASTM, AOAC-International, and USGS are acceptable 
because these formats are documented and routinely followed by these 
organizations. Methods produced or approved by organizations that allow 
random formats would be required to be revised into a standardized 
format before submission for proposal at 40 CFR Part 136. This 
requirement would preclude confusion in methods.

B. Method Validation

    For purposes of the streamlining contemplated by this notice, EPA 
presents a tiered approach to validation of new methods. This approach 
consists of three tiers, dependent on the intended application of the 
new method. The tiers are single use, use within a given industry, and 
nationwide use, and the levels of validation required for new or 
alternate methods are consistent with these uses. As discussed above, 
only those methods that contain a new or alternate determinative 
technique would be required to undergo method validation studies.
1. Tier I--Validation of Single-Use Methods
    A single-use method would be applicable to a single discharge. 
Validation would be on that discharge and the method would be 
applicable to that discharge only. EPA believes that this tier would 
codify the present flexibility understood to be permitted in monitoring 
by encouraging permitting authorities and individual dischargers to 
determine unusual analytes of regulatory concern and to overcome matrix 
interferences. Method validation would consist of running four 
replicate tests in a single laboratory to establish single-laboratory 
performance data and applying the procedures given in the document 
titled Development of QC Acceptance Criteria to establish QC acceptance 
criteria for the method from the single-laboratory data.
2. Tier II--Validation of Single-Industry Methods
    This tier would be applicable to discharges in a given industry by 
industrial category or subcategory. Categorical effluent guidelines 
limitations are promulgated at 40 CFR Parts 400-505. Method validation 
would consist of running tests of a minimum of one sample from a waste 
stream from three different facilities in three separate laboratories 
(a total of nine analyses) to establish laboratory performance data for 
the QC tests specified in this notice. These performance data would 
then be used to establish QC acceptance criteria using the document 
titled Development of QC Acceptance Criteria.
3. Tier III--Validation of Methods for Nationwide Use
    Nationwide-use methods would be validated in one of two ways: (1) A 
classical interlaboratory study would be performed using study designs 
such as those used by EPA in past studies or by AOAC-International or 
ASTM and QC acceptance criteria would be developed using the 
traditional variance components analysis, or (2) a study design that 
attempts to include all variance components could be used. For example, 
QC acceptance criteria could be developed by running tests in waste 
streams from a minimum of nine industrial categories in nine separate 
laboratories (a total of nine analyses). One of the nine waste streams 
would be required to be from a publicly owned treatment works (POTW) to 
ensure coverage of this industrial category. Although the individual 
variance components would not be known, the overall variance could be 
estimated from the study. The advantage of this second approach is that 
the number of tests, and therefore the cost, is minimized. Further 
details of the use of these two approaches is given in the Development 
of QC Acceptance Criteria document made available with this notice. EPA 
seeks a public discussion of the utility of these two approaches.
    In order to implement this tiered approach, it is likely that a new 
table or tables would be published in 40 CFR Part 136 to define the 
level of validation and use for a method as well as the specific 
discharge and industrial category for methods that would be proposed 
and promulgated at Tiers I and II.
    As with the other aspects of this notice, EPA seeks a public 
discussion of this tiered approach and suggestions for other approaches 
that may be more efficient or less cumbersome. EPA is particularly 
interested in learning from the regulated community if this approach 
would aid in reducing monitoring costs and of overcoming matrix 
interferences. EPA is also particularly interested in learning if this 
approach would be cumbersome for permitting authorities to administer.

C. Submission Process

    Under the system contemplated by this notice, new methods and 
methods manuals would be submitted to the Office of Science and 
Technology (OST) which would coordinate proposal of the method(s) under 
40 CFR Part 136. The steps involved in developing and preparing a 
method for proposal are 

[[Page 47333]]
outlined below. It should be stressed that the preparer should 
communicate closely with OST throughout this process to ensure that the 
method will be suitable for proposal at the end of the process.
1. Determination That Method Is New
    The preparer should first determine whether the method is a new 
method or a modification of an existing method under the Agency's 
method flexibility initiative. The following sources should be 
consulted in making this determination:
     The FR/CFR reference that implements the system 
contemplated by this notice [citation].
     Technical Interpretation of Method Flexibility.
     Front-End Techniques that are Candidates for Method 
Modification under EPA's Method Flexibility Overture.
     Methods Considered Within the Scope of Existing Wastewater 
Methods Under the EMMC Performance-based Methods System.
2. Method Development
    Once it has been determined that a new method is warranted, the 
method should be developed and documented using the following sources.
     Guidelines and Format for methods to be proposed at 40 CFR 
Part 136.
     Development of QC Acceptance Criteria.
     The FR/CFR reference that implements the system 
contemplated by this notice [citation]--Standardized Quality Control.
3. Preliminary Method Submission
    Once the method has been written according to a standardized 
format, the preparer would document plans to validate the method, 
including a schedule. Section IV.B. Method Validation, should be 
consulted in planning for appropriate method validation.
4. Method Validation
    After writing and initial testing, the preparer would proceed with 
method validation according to the documented plans. Based on data from 
the validation study, the method may need to be modified and a further 
validation study may be required. After completing the validation 
study(ies), the preparer would write a detailed validation report. EPA 
may, at a later date, develop the format and requirements for such a 
report.
5. Preparation of Draft Preamble
    Once the method has been properly validated and the method and 
validation report are ready for submission, the preparer would develop 
a draft preamble for proposal of the method at 40 CFR Part 136. If the 
system contemplated by this notice is found to be desirable, a template 
for the draft preamble could be provided by EPA to assist the preparer.
6. Submission of Final Method, Validation Report, and Draft Preamble
    The final method, validation report, and draft preamble would be 
sent to EPA. EPA would review these documents and communicate with the 
preparer regarding questions and to clarify any outstanding issues. EPA 
would then finalize the preamble, include the appropriate documents in 
the docket, and submit a proposal for inclusion of the method in 40 CFR 
Part 136 to the Federal Register for public comment.
7. Submission of Proprietary Methods or Methods Containing Proprietary 
Equipment or Substances
    Under several statutes, EPA is prohibited from releasing materials 
marked as confidential business information (CBI) and has treated 
analytical methods as CBI when so marked. The Agency believes that the 
objective of promulgating analytical methods is for the full enjoyment 
by the public in making determinations of pollutants in the 
environment. Therefore, EPA believes that proprietary methods should 
not be included in part 136. However, EPA believes that proprietary 
equipment or substances used in methods should be maintained as 
confidential. For example, the liquid phases in gas chromatographic 
columns are usually known by their confidential name, such as DB-1, 
SPB-octyl, and Dexsil, although EPA also believes that the nature of 
proprietary equipment and substances eventually becomes known. EPA 
seeks a public discussion of whether or not confidential methods should 
be promulgated at 40 CFR Part 136, and whether the practice of 
including proprietary equipment and substances in methods should be 
continued, or if EPA should require identification of these equipment 
and substances.
V. Harmonization of Methods

A. Harmonization of 40 CFR Part 136 Methods With Other EPA Methods

    The methods required for NPDES compliance monitoring are the 40 CFR 
Part 136 Methods. Although there are many similarities between the 
technical details of methods from other EPA programs and in other 
methods, it has not been acceptable to date to use another method for 
NPDES monitoring in place of a 40 CFR Part 136 Method. For instance, 
methods from the Office of Solid Waste SW-846 manual have not been 
acceptable. However, with the flexibility discussed in this notice, 
other methods may be permitted, provided that the requirements given in 
the method and discussed in this notice and its supporting documents 
are met. This includes the requirement that the determinative step and 
specificity are equivalent, and that the performance of the method is 
equal to or better than the performance of the Reference Method. The 
Reference Method must be a 40 CFR Part 136 method. The other methods 
can be EPA methods, methods from other organizations, or methods 
developed by a laboratory or other organization.
    In addition to the allowance for use of other methods, if the 
requirements described in this notice are followed both in letter and 
in spirit, methods from several of EPA's analytical programs can be 
fused into a single method acceptable for use in compliance monitoring 
under the wastewater program and under the EMMC PBMS. For example, 
using the checklist described in this notice and detailed in the 
document titled Methods Considered Within the Scope of Existing 
Wastewater Methods Under the EMMC Performance-based Methods System 
(EMMC PBMS Guidance), and the analyte lists and QC acceptance criteria 
in the methods to be fused, EPA Superfund Contract Laboratory Program 
(CLP) Method OLM02.0, EPA Office of Groundwater and Drinking Water 
(OGWDW) Method 524.2, and Office of Solid Waste SW-846 Method 8260 can 
be made acceptable for use in the wastewater program as a front-end 
modification of Method 624.
    The process consists of using the capillary column specified in 
methods OLM02.0, 524.2, and 8260; testing for all analytes listed in 
all methods, performing all performance tests in all methods; and 
meeting the most stringent of the QC acceptance criteria for each test 
in all methods. For acceptance in the wastewater program under this 
notice, it would be necessary to perform the standardized QC described 
above and meet the QC acceptance criteria in Method 624. In addition, 
and while operating under Method 624, it would be necessary to spike 
all analytes listed in the permit, and not just the subset of analytes 
required as the matrix spike in the CLP method. The spike would 
therefore be specific to the discharge. Alternatively, all analytes 
listed in Method 624 could be spiked. Further, if the spiked 

[[Page 47334]]
analytes are not recovered in the normal range (as specified in the QC 
acceptance criteria in Method 624), it would be necessary to analyze 
the QC check sample given in Method 624 to demonstrate that a matrix 
effect had or had not occurred, and that the laboratory was in control. 
All other performance requirements in Method 624 would also need to be 
met and the checklists in the EMMC PBMS Guidance would need to be 
completed to document the use of a front-end modification of Method 
624.

B. Standardization of Methods Across Agency Programs

    Under the auspices of EPA's EMMC, the various program offices are 
working to arrive at a single method that transcends Agency programs 
for the most commonly used methods. The first method being studied is a 
method for determination of volatile organics by purge and trap gas 
chromatography/ mass spectrometry (GC/MS). If agreement between the 
program offices can be reached, this method will encompass the analyte 
lists and quality control requirements in EPA's Drinking Water, 
Wastewater, Solid Waste, and Remedial programs. Several possible 
approaches to the development of analyte lists and QC requirements for 
consolidated methods are being discussed within the Agency. One 
possible approach is to examine the QC specifications required by each 
program and include the most stringent requirements in the consolidated 
methods. Another possible approach is to re-develop analyte lists and 
QC specifications for the integrated methods; this approach would 
necessitate interlaboratory studies that could require extensive Agency 
resources. EPA seeks a public discussion concerning approaches towards 
integration of Agency methods.

VI. Other Streamlining Issues

A. Standardized Data Elements for Reporting

    EPA is also considering standardized data elements for reporting, 
with an eye toward reporting of results on magnetic media and via 
electronic means. In certain of its programs, EPA has been accepting 
analytical data on magnetic media in precisely defined formats for more 
than 10 years. However, a more generalized format may have broader use. 
One such format is the Department of Energy Electronic Data Deliverable 
Master Specification (DEEMS). EPA seeks a public discussion as to 
whether the Agency should further pursue electronic formats for 
reporting data generated using the 40 CFR Part 136 methods.
B. Withdrawal of Outdated Methods

    EPA is also considering withdrawal of methods that the Agency 
believes are obsolete or are no longer used. For example, 40 CFR 136, 
Table ID, footnote 3 references methods published in 1978 that include 
thin-layer chromatography (TLC) methods. EPA believes that TLC methods 
have been outdated by gas chromatography and high performance liquid 
chromatograph methods for the analytes to which the methods published 
in 1978 are applied. EPA is therefore considering a careful examination 
of Tables 1A through 1E of Part 136 for obsolete or outdated methods, 
and proposing removal of those methods for which newer methods are 
available.

C. Incorporation by Reference

    It is EPA's intention to reduce the number of pages published in 
the Federal Register and the Code of Federal Regulations by 
incorporating proposed and promulgated methods, respectively, by 
reference. The approach is intended to reduce the expense of 
publication in the FR and CFR. EPA also believes that publication in 
these documents is unnecessary because analytical methods are esoteric 
in nature and, therefore, not of interest to the general public. In 
place of publication in the FR and CFR, copies of the methods would be 
made available through such outlets as the Government Printing Office, 
the EPA Water Resource Center, the National Technical Information 
Service, and through meetings such as the Pittsburgh Conference, the 
annual meeting of the Water Environment Federation, and EPA's 
Conference on Analysis of Pollutants in the Environment held annually 
in Norfolk, Virginia. EPA is also exploring distribution of the full 
text of the proposed and promulgated 40 CFR Part 136 methods on-line.
    Consistent with this approach, EPA would also withdraw the 40 CFR 
136 Appendix A methods from the CFR and would incorporate these methods 
by reference, thus reducing the number of pages of material published 
annually in the CFR by more than 240.
    EPA will discuss this removal of methods from publication in the FR 
and CFR, the use of the Internet for distribution of methods, and other 
avenues of distribution that could be used to make methods more 
accessible to interested parties.

VII. Discussion of Information Contained in This Notice

    EPA is particularly interested in eliciting constructive discussion 
that will allow the Agency to incorporate flexibility into existing 
methods and streamline proposal and promulgation of new methods under 
40 CFR Part 136. On the other hand, EPA is interested in compelling 
reasons why such a program may not work, even with extensive built-in 
controls to assure that the results produced by modified or new 
analytical methods are reliable. At this juncture, the floor should be 
considered open for discussion. EPA looks forward to working with all 
interested and concerned parties to produce an improved system for 
methods approval under the 304(h) program.

    Dated: September 1, 1995.
Tudor T. Davies,
Director, Office of Science and Technology.
[FR Doc. 95-22608 Filed 9-11-95; 8:45 am]
BILLING CODE 6560-50-P