United States Office of Air Quality
Environmental Protection Planning and Standards
Agency Research Tnangle Pa'k NC 2771 1
EPA-450/3-84-006
March 1984
Air
Methods 6 and 7
Quality Assurance
and Quality Control
Revisions —
Summary of
Comments and
Responses
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EPA-450/3-84-006
Methods 6 and 7 Quality Assurance
and Quality Control Revisions —
Summary of Comments and Responses
Emission Standards and Engineering Division
U.S. ENVIRONMENTAL PROTECTION AGENCY
Office of Air and Radiation
Office of Air Quality Planning and Standards
Research Triangle Park, North Carolina 27711
March 1984
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This report has been reviewed by the Emission Standards and Engineering Division of the Office of Air Quality
Planning and Standards, EPA, and approved for publication. Mention of trade names or commercial products is not
intended to constitute endorsement or recommendation for use. Copies of this report are available through the
Library Services Office (MD-35), U.S. Environmental Protection Agency, Research Triangle Park, N.C. 27711, or
from National Technical Information Services, 5285 Port Royal Road, Springfield, Virginia 22161.
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TABLE OF CONTENTS
Page
Chapter 1. INTRODUCTION 1
Chapter 2. SUMMARY OF CHANGES SINCE PROPOSAL 2
Chapter 3. SUMMARY OF PUBLIC COMMENTS AND RESPONSES 3
Table 1. LIST OF COMMENTERS 19
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CHAPTER 1
INTRODUCTION
On March 30, 1983, the U.S. Environmental Protection Agency (EPA)
published "Quality Assurance and Quality Control Revisions to Methods 6 and
7," in the Federal Register (48 FR 13388). These revisions will require
source testers to analyze audit samples when making compliance determi-
nations in order to assess their analytical accuracy. These revisions were
proposed under the authority of Sections 111, 114, and 301(a) of the Clean
Air Act, as amended.
Public comments were solicited at the time of proposal. An invitation
to request a public hearing was issued to provide interested persons the
opportunity for oral presentation of data, views, or arguments concerning
the proposed revisions, but no person desired to make an oral presentation.
The public comment period was from March 30, 1983, to June 13, 1983.
Letters concerning issues relative to the proposed revisions were
received from 15 commenters. A detailed discussion of these comments and
responses is summarized in this document. The summary of comments and
responses serves as the basis for the revisions which have been made
between proposal and promulgation.
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CHAPTER 2
SUMMARY OF CHANGES SINCE PROPOSAL
Method 6
1. Section 3.3.6. The audit sample set will not include a known
sample. The tester is requested to notify the quality assurance (QA)
office or the appropriate enforcement agency at least 30 days prior to the
test date to allow sufficient time for sample del i very-
2. Section 4.4. EPA's Source Branch is listed as one source of known
quality control samples. A single audit per 30-day period for the same
enforcement agency is allowed, and the proposed provision for quarterly
audits when samples are analyzed frequently has been dropped. The
analyst's name is to be included when reporting audit and compliance results,
If a reanalysis is required, the initial and reanalysis audit values are to
be reported.
3. Section 6.4. The equation for calculating the relative error for
the QA audit samples is included.
Method 7
The changes for Method 7 are the same as listed for Method 6 except
for Section 6.4.
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CHAPTER 3
SUMMARY OF COMMENTS AND RESPONSES
QUALITY ASSURANCE AND QUALITY CONTROL REVISIONS
TO METHODS 6 AND 7
1. D-l, D-5, D-14
Comment: We support the proposed additions which appear to be
both adequate and reasonable. Although they may require additional
work and expense, the resultant benefits should justify it. The
proposed measures will provide greater uniformity and confidence to
the analytical results, and the improved scientific data base should
also enhance decision making during the development of future standards.
Response: No response necessary.
2. D-4
Comment: Some regulating agencies already require audit analysis
for compliance testing, monitor certification, and for data to be used
for background studies. We suggest that audit analysis be required for
compliance determinations and that the Administrator have the option
of requiring audits for other tests.
Response: Audit analysis as a part of monitor certification and for
data to be used for background studies is an allowable option, and in some
cases, may be required by the Administrator. The Agency, however, does
not have the authority to make this mandatory in all cases.
3. D-4
Comment: It is not clear what criteria should be used for
determining if audit samples are required only on a quarterly basis.
We have had the experience where testing contractors have assured us
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that they participate in and pass the quarterly audits yet still do
not analyze the audit samples within the specified range on the first
try. We do not desire to be overly burdensome on the QA aspect, but
we feel that there is a definite need for the audit samples, or a
well-defined method of determining the analytical accuracy of the
laboratory.
Response: The quarterly auditing allowance for analyses performed
on a frequent basis has been changed. The revised requirement is to
analyze audit samples at least once per month. This discourages the
use of 3 month-old analytical reagents as allowed in the quarterly
audit and also eliminates the need to perform an audit with each set of
compliance samples if samples are analyzed on a. frequent basis.
4. D-ll
Comment: In general, we agree with the need for QA in source
emission data that are obtained to demonstrate compliance with emission
standards. However, we feel the requirements should be based upon
sound statistical analysis of available data, and this does not appear
to be the case with this proposal. The likely impact of the proposed
rule can be determined by examining the 1977 through 1980 Environmental
Protection Agency (EPA) inter!aboratory data. If the proposed 5 percent
criterion for S02 were used, anywhere from 8 to 42 percent of the
laboratories would have had unacceptable performance. If the proposed
10 percent were used for NOX, between 27 and 70 percent of the
laboratories would have failed the test. There is also a strong
indication that samples of lower concentration were more likely to be
found unacceptable than those of higher concentration.
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It is suggested that, initially, the EPA audit samples be used to
identify sources of error in the Methods 6 and 7 analyses and
calculations. Once these are identified, a guideline document should
be prepared to assist analysts performing these analyses. Then, accuracy
criteria for the two methods can be developed and implemented.
Response: The rationale and data used to support the proposed rule
are listed in the background information report that was announced in
the preamble to the regulations. The report is based upon previous EPA
inter!aboratory audit surveys. The survey data were studied to
determine the sources of tester errors and to find some indications of
laboratory capabilities. The sources of correctable errors (e.g.,
analytical biases, calculation, and reporting errors) were identified
and corrected, and the data were reanalyzed. The resultant figures
showed that 95 percent of the laboratory tests for S02 were within
5 percent, and 86 percent of the tests for NOX were within 10 percent
of the true values. The audit samples will not be prepared in low
concentrations.
5. D-6
Comment: The proposed acceptance levels, within 5 percent for
S02 and 10 percent for N02, are more restrictive than the respective
7 and 20 percent levels recommended by the EPA QA Handbook for Air
Pollution Measurement Systems (Redbook). The Redbook values are based
on interlaboratory performance surveys for reference Methods 6 and 7.
If a more recent interlaboratory survey has been performed and the
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results justify the stricter tolerances, the data should be presented
for review. If the data are not available, the stricter tolerances are
not justifiabl e.
Response: See the response to Comment 4. The background
information report shows that by eliminating correctable mistakes,
much of the error margin is eliminated.
6. D-12
Comment: Notwithstanding brief mention of a background document,
the proposal does not indicate the existence of a data base that
demonstrates the need for or reasonableness of additional QA
requirements. The given justification is that "the current regulation
includes only limited QA requirements and as a" result of this proposed
regulation, the quality of compliance data will improve." Regulation
should not be founded on such a generalized, unsupported statement but
upon statistically sound and representative data.
Response: See the response to Comment 4. The analytical errors
revealed in the inter!aboratory survey indicate the need to have an
auditing requirement.
7. 0-2
Comment: The rulemaking ignores the logistic problems that will
be created with a one-on-one audit requirement, especially for control
agencies conducting numerous tests.
a. How will EPA guarantee delivery of the audit samples?
b. Will EPA ensure that the concentrations are within the
analytical range of the samples?
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c. Can it ensure a different audit concentration for each
request?
d. Can EPA guarantee fast delivery of audit samples? Our
regulations require analysis within 48 hours of sample collection.
Response: EPA will be able to respond if notified soon after a
decision has been made to perform a compliance test. The quality
assurance revisions will have instructions to notify the EPA Quality
Assurance Management Office 30 days prior to the actual test.
Since the compliance sample concentrations have to fall within the
calibration range of the standards for Method 7 and within the titration
volume range for Method 6, the audit sample concentrations will be
within these analytical ranges. Coordination within the auditing
program will assure that sources receive different audits on different
requests.
8. D-7
Comment: Laboratories performing Methods 6 and 7 analyses
should be required to participate in the semiannual EPA inter!aboratory
surveys to evaluate their analytical procedures and personnel. Perhaps,
certain standards of performance on their work should be specified. The
survey offers enough time for submittal of results to allow freedom in
scheduling the analysis to coincide with compliance tests.
Response: The semiannual interlaboratory survey will be modified to
place primary emphasis on the new auditing program. Standards of performance
are specified in the new requirements which evaluate analytical procedures
and personnel.
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9. D-9
Comment: The proposed rule apparently ignores the ongoing EPA
interlaboratory audit program for Methods 6 and 7 which is done
semi annually. Since this program is underway, we feel that it is
redundant and unnecessary to add a second program requiring more
frequent audits. More frequent audit analyses should only be
required in those cases where the ongoing interlaboratory program
points out a deficiency in a laboratory's quality control program.
Response: See the response to Comment 8. Participation in the
interlaboratory auditing program gave laboratories an indication of
their relative analytical performance but did not identify or eliminate
inaccuracies experienced on an actual test due to using different or
inexperienced personnel, mistakes in the standards preparation,
calculations, reporting, etc. There is a need to audit each compliance
test whenever there is a change in the analyst, analytical reagents, or
analytical system to maximize the accuracy of the determined results.
A more frequent auditing program than the current EPA interlaboratory
survey is needed.
10. D-6
Comment: The EPA Redbook recommends the appropriate enforcement
agency should provide the audit samples after notification of intent to
demonstrate compliance by the source. This recommendation allows the
Agency the option to distribute the audit samples to the sources of
unproven analytical abilities and minimize the workload of both the
Agency and the source.
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If QA procedures are to be added, they should allow for the
continued discretion of the Agency in requiring the audit in contrast
to forcing the source to perform the audit regardless of the known
analytical abilities of that source.
Response: All testers should be audited to detect possible errors
in their analytical technique. Even laboratories of proven ability
occasionally experience oversights that affect the results of compliance
analyses.
11. D-13
Comment: We suggest that a voluntary audit program be developed
that allows interested parties to run compliance samples on a
predetermined schedule. Any interested laboratory could be audited by
the Agency and be supplied with written confirmation of the audit
results. In this manner an owner or operator could know the
qualifications of a contractor prior to the issuance of a contract, the
Agency would be assured of the laboratory results, and the documented
record of the QA program and compliance testing will be preserved.
Response: See the response to Comment 9. A voluntary auditing
program that would make known the qualifications of contractors for
the source operator to evaluate would be weakened and its importance
lessened by the number of laboratories that opt to abstain from
participation.
12. D-10
Comment: We have very serious reservations regarding both the
necessity and practicability for analyzing audit samples at least
once each quarter for all compliance determinations. In view of the
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finite resources of both EPA and industry, it is strongly recommended.
that sample auditing for critical or suspect compliance determinations
only be considered.
Response: See the responses to Comments 5 and 9. In view of the
need for improved analytical performance as indicated by past
interlaboratory audit surveys, we feel the small increase in resources
that will be experienced will be justified by the increased reliability
of the compliance results.
13. D-8
Comment: The proposed rules impose an additional level of
regulation. The rules state the Administrator may choose to use
compliance test results to determine the compliance or noncompliance
status of the affected facility regardless of the audit sample results;
and he may waive reanalysis if the audit analysis fails. Therefore,
the rationale for the need to have QA regulations is missing.
Reputable analytical facilities have and continually update their
QA procedures. The proposed requirements are limited in nature and
probably less comprehensive than existing laboratory QA procedures.
Response: Administrator discretion comes into play in only two
cases: when the test shows the source is substantially below the
standard, but the audit is marginally failed; and when the source is
substantially above the standard, but the audit is marginally failed.
In each case, the application of a correction factor would not change
the compliance or noncompliance status of the source. Acceptance of
the test results in each case is allowed because compliance or
noncompl iance is clearly shown and would not be affected by the
additional error above that normally allowed.
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14. D-8
Comment: The proposed rules do not provide recourse if the
analyses are not within the specified boundaries. There needs to be a
mechanism for a laboratory to resolve any differences in analytical
results without necessarily performing a reanalysis.
Response: The mechanism for resolving analytical differences
will depend upon the source of error. If the standards were incorrectly
made, a new set would have to be prepared and the samples reanalyzed. If
only a calculation error is made, then data correction without reanalysis
would correct the problem. It is recommended that a known quality
control sample be analyzed prior to the audit and compliance samples to
optimize the system accuracy and precision.
15. D-13
Comment: Administrator discretion in accepting failed audit
results is wholly inconsistent with accepted QA practice. It is not
known whether the data will be used as submitted or a correction factor
developed from the audit results. If the Agency has determined that 5
percent is the maximum allowable error, all associated data with such
an error should be invalidated with no exceptions and no corrections.
The results should not be left to the arbitrary discretion of an
individual.
Response: See the response to Comment 13. The data will be used
as submitted without applying a correction factor.
16. D-5, D-14
Comment: The proposed audit would not guarantee the accuracy of
emission data since the evaluation is on the analysis and not on the
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sampling portion. Although the proposed additions are a step in the
right direction, it would be hetter to have a procedure to evaluate both
the sampling and analysis, even though this would not be ideal because
of possible matrix or interference effects in the actual source
samp! es.
Response: We agree. However, the Agency's experience in auditing
the sampling procedure (using gas cylinders) has found this approach
to be impractical, expensive, and the benefits received would not
justify the effort required to perform it. If a simple auditing technique
can be developed, EPA will consider such an audit in the future.
17. D-2, D-9
Comment: An audit per set of compliance-samp! es is over-
regulation. The proposed quarterly exemption only covers repetitive
testing at a given source. Most control agencies will have a central
laboratory and will use different personnel and analytical systems.
The NOX analyses are very time consuming, and a team of chemists may
be routinely assigned to analyze the samples so they can be completed
in a timely manner. The requirement that only one person analyze NOX
samples (Paragraph 4.4) could delay the preparation of the compliance
test report past deadlines now set by the States and EPA. The proposal
should be amended to allow more than one person to analyze the samples.
Any analytical variations would be checked by quality control
procedures currently incorporated in EPA methods (e.g., equipment
calibrations, duplicate testing and analysis, and inter!aboratory
testing). Furthermore, since the "oneness" rationale is not and should
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not apply to the sample collection phase, it should not be mandated for
the analyst and analytical equipment phase.
Response: See the response to Comment 3. The intention of the
rule is not to restrict the analysis to one person but to ensure that
all parties involved in the analysis of the compliance samples likewise
take part in the analysis of the audits. The names of all persons
participating in the audit analysis are to be included in the report
that is submitted to the appropriate enforcement agency.
18. D-6
Comment: The requirement to analyze two unknown samples as well
as a known sample prior to the analysis is redundant. Each component
of the analysis is either checked for impurities or standardized
against a primary standard.
Response: The QA audit is an overall check of the method's quality
control. These quality control checks in the methods are beneficial but do
not guarantee accuracy. Standardization against primary standards is
subject to such inaccuracies as weighing errors, dilution errors,
calculation errors, etc.; the QA audit will detect such errors. Analysis
of the known sample is optional.
19. D-15
Comment: We oppose the proposed rule because it will increase the
cost of conducting a compliance test considerably and will put the smaller
stack sampling firms at a competitive disadvantage. These firms may be
.forced to discontinue the testing services because they will not be
able to absorb the additional cost and remain competitive. In our
opinion, the benefit gained by the improved QA does not justify the
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increased cost. Both methods.currently provide for adequate
standardization of reagents and provide detailed analytical procedures
that should yield acceptable results with an acceptable degree of
accuracy.
Response: See the responses to Comments 12 and 18. The increased
cost associated with implementing QA requirements should not be
substantial enough to give larger firms a competitive advantage.
20. D-8, D-12
Comment: One-concern of the proposed rule is cost. The first
time cost to analyze the audit samples would not be significant since
analysis would be done with the compliance samples. However, costs
may be very significant if reanalysis is necessary due to audit samples
of poor quality, failure to acquire audit samples when needed, or a
subsequent determination that the specifications are unduly stringent.
Moreover, there is no evidence in the proposal that EPA considered
compliance retesting costs to any extent in the determination of
economic impact.
Response: The background information report shows that a very
high percentage of representative laboratories are capable of analyzing
EPA-prepared audit samples and passing the proposed acceptance levels
once correctable mistakes have been eliminated. Past experience also
indicates that increased familiarity with the methods (especially
Method 7) tends to increase operator accuracy. The known quality control
sample will point out deficiencies in the analysis which can be corrected
and eliminated for subsequent tests. Laboratories employing qualified
personnel and good quality control procedures will incur little additional
expense due to reanalysis.
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21. D-7
Comment: We are concerned about the delay that would be caused
by repeating the entire analysis procedure if audit results fall
outside the acceptable range. The delay due to reordering, receiving,
and finally reanalyzing the audit samples could impede laboratory
routine and delay report submittal which, in some instances, is
required within 30 days. The entire procedure is cumbersome and
counterproductive to lab efficiency.
Response: The entire procedure should increase lab efficiency
and accuracy since analysis error will be kept within an acceptable
level. Each S02 and NOX audit vial contains enough solution for at least
two duplicate tests, so reordering samples for reanalysis should
not be necessary. In the event a reanalysis is required, retesting can
be avoided by saving the remainder of the samples for reanalysis.
22. D-7
Comment: Rather than performing an analysis on unknown samples,
it may be more beneficial to analyze EPA-supplied specimens of known
concentration prior to running compliance test samples. If necessary,
require that results of the standards analysis be included with the
compliance test report. In this way, mistakes can be immediately
identified and resolved before continuing further.
Response: Known samples are available from EPA and can be used
for that purpose. The incentive to maximize accuracy by a tester would
be lessened if analysis of the known were required instead of the blind
audit. It would be easiest to resolve mistakes by reporting the audit
results by telephone. In this manner, mistakes will be immediately
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known and can be resolved before writing the test report and having to
wait for a reply.
23. D-2
Comment: A single audit check per quarter should be adequate.
Individual precision checks should be accomplished by requiring that
the known concentration be analyzed with each set of compliance samples
collected during the quarter.
Response: See the responses to Comments 3 and 22.
24. D-8
Comment: The proposed rules do not address the origin, quality,
or nature of the audit samples. This is an important concern if a
laboratory's performance is being assessed based on these samples.
A reference standard for preparation of the audit samples should be
cited.
Response: The audit samples are to be obtained from EPA as detailed
in Sections 3.3.6 for Method 6 and 3.3.9 for Method 7.
25. D-3, D-6
Comment: We object to the requirement that only EPA-derived
audit samples be accepted when making compliance analyses. We
propose that internally-generated standards be allowed in lieu of
the EPA standards. The practice of analyzing standards is routinely
followed in good laboratories with good QA procedures. These
laboratories should be allowed to continue such practices without the
added workload of EPA audit samples.
In addition, the potential exists for error in the audit sample
preparation or in documenting the actual audit concentrations.
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Response: See the response to Comment 18. The potential for
errors in preparation and documentation of actual concentrations would
be compounded if each laboratory were allowed to generate its own audit
samples. Any error in an EPA-derived audit would be rapidly detected
since many laboratories will be analyzing them. To ensure fairness in
meeting the audit accuracy levels, a single source of samples is needed
to serve as a reference for all laboratories.
26. D-13
Comment: A serious concern is that the audit sample results
can only be obtained if the audit and set of compliance results are
telephoned to the Agency, presumably by the contractor. It is
unthinkable to use telephone communication for compliance determinations
as the Agency proposes.
Response: Reporting the audit results by telephone is an option
and not a requirement. Submission of a written test report is still
mandatory in this case. The allowance for telephone communication
enables the tester to determine at an early stage whether the audit is
passed and hence the compliance data acceptable, or whether the audit
is failed, and a reanalysis is necessary. Determination of the audit
status before the test report is written and before the audit and
compliance samples have aged substantially would eliminate much of the
unnecessary work and expense created if it is determined at a later
date that a reanalysis is needed.
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27. D-2, D-ll
Comment: In Method 6, Section 6.4 is lacking the relative error
equation for the QA audits.
Response: This addition has been made.
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Table 1. LIST OF COMMENTERS
Docket Number A-80-57
Document Number
IV-D-1
IV-D-2
IV-D-3
IV-D-4
IV-D-5
Commenter/Affi 1 i ati on
Dick Serdoz, Air Quality Officer
State of Nevada Dept. of
Conservation and Natural Resources
Division of Environmental Protection
Carson City, Nevada 89710.
Chief
Services and
Ben A. Brodovicz,
Div. of Technical
Monitoring
Commonwealth of Pennsylvania
Dept. of Environmental Resources
Post Office Box 2063
Harrisburg, Pennsylvania 17120
Thomas A. Lowe, Manager
Analytical Research
Kaiser Aluminum and Chemical
Center for Technology
Post Office Box 877
Pleasanton, California 94566
Corp.
Charles S. Krick, Environmental
Engineer
State of Delaware Dept. of Natural
Resources and Environmental Control
Division of Environmental Control
Edward Tatnall Building
Dover, Delaware 19901.
Charles D. Mai loch, Director
Regulatory Management, Air
Environmental Policy Staff
Monsanto Company
800 N. Lindbergh Boulevard
St. Louis, Missouri 63166.
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Table 1. LIST OF COMMENTERS
Docket Number A-80-57
(Continued)
Document Number
IV-D-6
IV-D-7
IV-D-8
IV-D-9
IV-D-10
IV-D-11
Commenter/Affi 1 i ati on
Douglas G. Mercer, Superintendent
Environmental Programs
Texas Gulf Chemicals Co.
Post Office Box 48
Aurora, North Carolina 27806
J.M. Reinke, Manager
Survey and Evaluation
Stationary Source Environmental
Control Office
Ford Motor Company
One Parklane Boulevard
Dearborn, Michigan 48126
Roger D. Dodds, Air Quality Engineer
Environmental Dept.
Wisconsin Electric Power Co.
231 W. Michigan
Post Office Box 2046
Milwaukee, Wisconsin 53201
Robert L. Pearson, Administrator
Environmental Affairs
Public Service Company of Colorado
Post Office Box 840
Denver, Colorado 80201
V.C. Eissler, Vice President
North American Production
Conoco, Inc.
Post Office Box 2197
Houston, Texas 77252
Ashok K. Jain, Manager
Engineering Projects Research
National Council of the Paper
Industry for Air and Stream
Improvement
Southern Regional Center
Post Office Box 14483
Gainesville. Florida 32604
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Table 1. LIST OF COMMENTERS
Docket Number A-80-57
(Continued)
Document Number
IV-D-12
IV-D-13
IV-D-14
IV-D-15
Commenter/Affiliation
T.C. Owen, Director
Corporate Office of Environmental
Affairs
Union Camp Corporation
Post Office Box 1391
Savannah, Georgia 31402
Wayne T. Swallow, Supervisor
Regulatory and Environmental
Monitoring
Public Service Indiana
Plainfield, Indiana 46168
Theodore L. Kinne, Director
Construction and Operations
Interstate Natural Gas Association
of America
1660 L Street, N.W.
Washington, D.C. 20036
Herman A. Fritschen, General Manager
Safety and Environmental Services
Cities Service Company
Box 300
Tulsa, Oklahoma 74102
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TECHNICAL REPORT DATA
(Please read Instructions on the reverse before completing)
1. REPORT NO.
EPA-450/3-34-006
3. RECIPIENT'S ACCESSION NO.
4. TITLE AND SUBTITLE
Quality Assurance and Quality Control Revisions to
Methods 6 and 7
5. REPORT DATE
March 1984
6. PERFORMING ORGANIZATION CODE
7. AUTHOR(S)
8. PERFORMING ORGANIZATION REPORT NO.
Emission Standards and Engeneerinq Division
9. PERFORMING ORGANIZATION NAME AND ADDRESS
Emission Measurement Branch (MD-19)
Emission Standards and Engineering Division
U.S. Environmental Protection Agency
Research Triangle Park, North Carolina 27711
10. PROGRAM ELEMENT NO.
11, CONTRACT/GRANT NO.
rj. SPONSORING AGENCY NAME AND ADDRESS
13. TYPE OF RE PORT AN D PERIOD COVERED
DAA for Air Quality Planning and Standards (MD-10)
Office of Air, Noise, and Radiation
U.S. Environmental Protection Agency
Research Triangle Park, North Carolina 27711
14. SPONSORING AGENCY CODE
EPA/200/04
.UI-PLEMENTARY NOTES
!u ABSTRACT
This document addresses the public comments submitted after proposal of the
rulemaking in the Federal Register. Changes made to this rulemaking as a result
of these comments are included. This document serves as the basis for the revisions
which have been made to the rulemaking between proposal and promulgation.
KEY WORDS AND DOCUMENT ANALYSIS
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b.lOENTlFlERS/OPEN ENDED TERMS
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Unclassified
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