Summary of Comments and Responses on 

Restructuring of the Stationary

Source Audit Program

Prepared August 2010

Proposed in the Federal Register on

June 16, 2009
(This page included to provide for two sided copying)
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TABLE OF CONTENTS

Section No. Page

1.0 Summary 1

2.0 List of Commenters 2

3.0 Public Comments and Responses 4

Supportive Comments

EPA should rely on accreditation program instead of audit program

Alternatives to Restructuring the Audit Program

Test data bias with respect to the audit program

Terms need defining or clarifying

. Audit sample failure and non-compliance

Reporting period

Choosing correct concentration for an audit sample

EPA cost estimate is not accurate

Should set a limit on the cost of audit samples

ICR cost estimates are incomplete

Requiring same analyst and analytical system for sample analysis

When are audit samples required

Audit sample availability

Setting acceptance limits 

Audit samples should not apply to instrumental methods

Notice and comment procedure

Field analysis of audit samples 

Audit sample matrix

Audit results reporting and availability

External QA program
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No justification for program

Consistency

Ordering audit samples

EPA maintain list of Audit providers

EPA’s 2003 study on quality gas cylinder samples

Audit requirements in methods

EPA’s proposal is premature 

Audit samples should be delivered to lab

Audit samples on test site during testing 

VCSB standard does not meet EPA’s needs

Gas audit samples entry point

TNI’s finalized standards in the EPA final rule
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1.0 SUMMARY

On June 16, 2009, the U.S. Environmental Protection Agency (EPA) proposed 

Restructuring of the Stationary Source Audit Program (SSAP). This action proposed 

amendments to the General Provisions to allow accredited providers to supply stationary sources 

with audit samples from the accredited providers instead of from EPA as is the current practice. 

This document outlines the criteria an accredited provider program must meet for the samples to 

be acceptable.

Requirements pertaining to the audit samples have all been moved to the General 

Provisions and have been removed from the test methods because the current language in the test 

methods regarding audit samples is inconsistent from method to method. Therefore deleting all 

references to audit samples in the test methods eliminates any possible confusion and 

inconsistencies. Under this proposed amendment, the requirement to use an audit sample during 

a compliance test will apply to all test methods for which commercially available audits exists.
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2.0 LIST OF COMMENTERS

Item Number in 

OAR-2008-0531 Commenter and Affiliation

0007

0008

0009

0010

0011

0012

0013

0014

0015

0016

0017

0018

Arlene Bell

Delta Air Quality Services, Inc.

Filipa Rio

Alliance of Automobile Manufactures 

Jerry Parr

The NELAC Institute

Michael Klein

New Jersey DEP

Scoot S. Slocum

Weston Solutions, Inc.

Maria Friedman

The NELAC Institute and

TestAmerica

Eileen C. Moran

Regional Air Pollution Control Agency

John Piotrowski

Packaging Corporation of America

Melvin E. Keener, Ph.D.

Coalition of Responsible Waste Incineration 

Robert D. Bessette

Council of Industrial Boiler Owners

Alabama Department of Environmental

Management

Brian Mader

3M Company
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2.0 LIST OF COMMENTERS

Item Number in 

OAR-2008-0531 Commenter and Affiliation

0019

0020

Jim Griffin

American Chemistry Council

Leslie Sue Ritts

0021

0022

0023

0024

0026

0027

0028

The National Environmental Development 

Association’s Clean Air Project

Stationary Source Expert Committee

The NELAC Institute

Jay Hudson, PE

Santee Cooper

Russell A. Woznaik

Dow Chemical Company

Lauren Friedman

Hunton & Williams, LLP

Ashok K. Jain

National Council for Air and Stream

Improvement, Inc.

Michael A. Palazzolo

Alcoa

Paul R. Jann

Dupont Engineering
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3.0 PUBLIC COMMENTS AND RESPONSES

Supportive Comments

1. Comment: This is a good change since a lot of testing that should have had audits 

now will. Audits can save facilities and testers money by identifying problems with their testing 

program. By identifying the problems this may salvage a poor test that is sufficient enough to 

show compliance after all the rest of the test information is reviewed. In time this will mean 

better testing and this should work to lower the cost for all involved. (0021)

Response: No response is necessary.

2. Comment: The commenter strongly supports EPA's decision to privatize the 

stationary source audit program (SSAP). The commenter currently witnesses 100 percent of the 

stationary source tests in their jurisdiction and requests numerous audits samples from EPA 

annually. In their experience, audits are crucial to verify the accuracy of the source test results. 

(0013)

Response: No response is necessary.

EPA should rely on accreditation program instead of audit program

3. Comment: The audit program is not needed because there are accreditation programs 

that certify laboratories and assess their analytical proficiency and accuracy. The proposed audit 

program duplicates the existing accreditation process. (0015, 0016, 0018, 0019, 0023, 0028)

Response: An accreditation program serves a different purpose than an audit program. 

An accreditation program looks to see if the laboratory has the capabilities to conduct the 

analysis in question. The audit program is an event driven program that looks to see at a 

particular time that the combination of equipment and analyzer is able to analyze the sample 

within an acceptable range. Analyzing the audit samples at the same time as the field samples 

using the same equipment and analyst give the compliance authority and the regulated 

community more confidence in the test results.

4. Comment: EPA should exempt NELAC accredited laboratories from the requirement 

to analyze audit samples under the proposed program. (0027)

Response: See response to Comment 3.

5. Comment: The audit program should be applied to the testing bodies or laboratories 

as part of an accreditation program instead of a compliance program and therefore have no 

bearing on the compliance status of the source. (0008, 0014, 0022)

Response: See response to Comment 3

6. Comment: EPA should conduct a proficiency testing program instead of an audit 

program in which source testing companies and analytical laboratories periodically analyze a
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sample. The commenters defined periodic as every year or every 2-3 years. One commenter 

suggested EPA maintain a list of testing consultants that passed the proficiency testing sample. 

(0008, 0018)

Response: A proficiency testing program serves a different purpose than an audit 

program. A proficiency testing program looks to see if the laboratory has the capabilities to 

conduct the analysis in question on a periodic basis. The audit program is an event driven 

program that looks to see at a particular time that the combination of equipment and analyzer is 

able to analyze the sample within an acceptable range. Analyzing the audit samples at the same 

time as the field samples using the same equipment and analyst gives the regulator and the 

regulated community more confidence in the test results.

Alternatives to Restructuring the Audit Program

7. Comment: EPA should maintain its current oversight responsibility for reference 

method development, sample audit and proficiency programs rather than relinquish it to third 

parties to ensure consistency and quality control. (0008)

Response: This rule does not in anyway change EPA’s responsibilities with respect to

reference method development. This rule only concerns the SSAP. EPA believes that the 

criteria outlined in the rule concerning what is required for an audit sample, an accredited audit 

sample provider (AASP), and an accredited audit sample provider accreditor (AASPA) ensures 

consistency and quality control.

8. Comment: EPA should keep handling the audit program. Many test consultants are 

unhappy about the proposed rule because it adds another step for the test consultants and their 

customers. The current program already contains sufficient Quality Assurance/Quality Control 

(QA/QC) parameters relative to what is proposed in the rule. (0018, 0021)

Response: It was not EPA’s intent when we proposed this rule to imply that the current 

audit program did not have sufficient QA/QC parameters but to allow the private sector to supply 

the audit samples. Since the audit samples are used to help validate the compliance results, EPA 

believes it should be the facilities’ responsibility to obtain the audit samples.

9. Comment: EPA needs to have oversight/authority over the audit sample providers 

instead of turning it over to a voluntary consensus organization. One commenter stated that 

“EPA should retain responsibility for selecting audit sample providers, approving audit samples 

and establishing sample “true values” if the results of audit sample analyses are to remain a 

legally enforceable component of compliance testing and source compliance with Federal and 

State regulations.” (0022, 0027)

Response: EPA retains oversight authority over all parties who have information that 

may be required by EPA to fully assess the proper implementation of the Clean Air Act (CAA). 

Section 114 of the Act gives EPA the authority to require the production of information, test 

results and answers to questions EPA may ask. EPA does not believe that it is necessary to

directly approve or provide audit samples in order to ensure integrity in this program.
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We do not believe it is necessary to develop a program to certify audit providers when 

there are already Voluntary Consensus Standard Bodies (VCSBs) in existence that have the 

capabilities to develop such a program with the input from a wide variety of stakeholders.

10. Comments: We recommend that if EPA is going to rely on private suppliers of audit 

samples, it should continue its current program and consider developing a procedure for charging 

user fees. (0026)

Response: The reason for the restructuring is not money. As we stated in the preamble, 

previously there were no private entities who supplied stationary source audit samples so EPA 

provided them but now there are private sources for these types of samples. Also EPA is not 

legally allowed to charge for the samples. If EPA were to charge a fee, it would be a violation of 

the Miscellaneous Receipts statue, 331 U.S.C. §3302(b) in addition to being an unlawful 

augmentation of EPA’s Congressional appropriation.

11. Comment: EPA should certify audit providers who provide the audit samples at cost 

to stationary source testing companies. (0020)

Response: EPA does not believe it makes sense to develop a program to certify audit 

providers when there are already VCSBs in existence who have the capabilities to develop such a 

program with the input from a wide variety of stakeholders. Also, EPA is not legally allowed to 

charge for the samples. It would be a violation of the Miscellaneous Receipts statue, 331 U.S.C. 

§3302(b) in addition to being an unlawful augmentation of EPA’s Congressional appropriation.

12. Comment: If EPA is unable to provide the audit samples on a gratis basis then EPA 

should provide the audit samples at a reasonable fee as part of existing protocol approval 

procedures. (0020)

Response: See response to Comment 10.

13. Comment: EPA should identify by rule the kind of samples it believes are necessary. 

If those samples could be produced cost-effectively by private providers then a simple 

requirement that sources purchase them should be sufficient to stimulate the market instead of 

restructuring the audit program. (0024)

Response: EPA is basically doing that in the rule except adding some criteria that the 

private providers must meet as a means to ensure consistency and quality in the audit samples 

and clarifying some inconsistencies. The use of the term “restructuring” seems to be confusing 

some people and giving them the idea that we are making major conceptual changes to the audit 

program which we are not doing. The fundamental audit requirements are the same as they have 

been for many years, the only real change is that EPA will not be providing the samples. 

14. Comment: If EPA’s reason for the rule is to address inconsistencies in the current 

general provisions concerning the use or availability of audit samples then EPA could address 

these aspects in the general provisions without a complete restructuring of the program. (0024)
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Response: See response to Comment 13. 

15. Comment: EPA should revise its proposal to remove references to specifications and 

organizations that do not currently exist and simply allow sources to obtain audit samples from 

private providers identified by EPA as providing acceptable samples. EPA can propose 

requirements to obtain samples from accredited providers in the future if and when the details of 

such an accreditation program are available to include in a rulemaking proposal. (0024)

Response: In accordance with 5 CFR 2635.702(c)(1) and (2), EPA cannot endorse any 

products, services or enterprises except: in furtherance of statutory authority to promote 

products, services or enterprises, or as a result of documentation of compliance with Agency

requirements or standards or the result of recognition for achievement given under an agency

program of recognition for accomplishment in support of the Agency's mission. This is not one 

of those cases.

16. Comment: EPA should expand and strengthen the current program in ways that 

would result in properly trained stack testing consultants and laboratory personnel instead of 

restructuring the audit program. (0008, 0026)

Response: The purpose of the audit program is to check the ability of a tester/analyst in 

combinations with the equipment to measure/analyze the emissions from a compliance test, not 

to train testers and analyst. It is the responsibility of the testing firm and laboratory to make sure 

their employees are properly trained.

Test data bias with respect to the audit program

17. Comment: The commenter noted that by definition a performance audit is intended 

to provide a measure of test data bias. The commenter stated that this program is presumably

intended as an audit of emissions sampling and analysis that would include the sampling 

technique, sample handling, sample preparation, and sample analysis accounting for the 

measurement biases relative to all steps of the process, however this is not clear in the proposed 

rule. Please clarify the intent of the performance audit. (0015)

Response: Most of the current audit samples only evaluate the analysis portion of the 

method. We believe that in the future restructured program more audits will assess the effect of 

sampling and handling because we defined blind audit sample as follows: “A blind audit sample 

is a sample whose value is known only to the sample provider and is not revealed to the tested 

facility until after they report the measured value of the audit sample. For pollutants that exist in 

the gas phase at ambient temperature, the audit sample shall consist of an appropriate 

concentration of the pollutant in air or nitrogen that will be introduced into the sampling system 

of the test method at or near the same entry point as a sample from the emission source.”

Terms need defining or clarifying

18. Comment: Rule needs to define “commercially available”. (0027)
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Response: EPA agrees that “commercially available” needs to be defined. The final rule 

was revised to state that an audit is commercially available when there are two or more sources 

for obtaining the audit. EPA is requiring two or more sources for audit samples to better ensure 

a competitive environment for setting audit sample prices and to minimize the potential for 

having a single audit sample provider from controlling the cost of audit samples.

19. Comment: Rule needs to define “true value”. The commenter assumes the term 

“true value” includes an expected value and some acceptable range of variability around the 

expected value but is concerned that multiple entities may have different interpretations of the 

term. (0027)

Response: “True value” is the spiked/expected value of the audit. The AASP must 

provide a separate value for the acceptance range.

20. Comment: Rule needs to clarify what types of “compliance test” are required to use 

audits. It is not clear if EPA intends to limit it to EPA tests for EPA purposes or if a local 

regulator could expand the audit requirements to similar test methods and programs. (0007)

Response: The audits are required for compliance tests that use the EPA test methods 

found in 40 CFR Parts 51, 60, 61, and 63 unless otherwise noted in the rule. An audit sample is 

required if a State or local compliance authority cites an EPA test method from Parts 51, 60, 61, 

or 63 to determine compliance with a rule approved into the State Implementation Plan or for 

enforcement purposes. An audit sample would be optional if the test is primarily for 

informational purposes and not required by a compliance authority.

21. Comment: The term “performance audit” (PA) should be revised to include the field

collection of audit samples. It should read “The PAs consist of blind audit samples supplied by

an AASP and collected and analyzed when intended for collection or simply analyzed when not 

intended for collection, during the performance test in order to provide a measure of test data 

bias.” (0021)

Response: EPA’s intent was to include sampling and analysis in the definition of 

performance audit. The definition in the final rule was revised to state that if gaseous audits are 

available then they must be collected by the field sampling system during the compliance test 

just as the compliance samples are collected.

Audit sample failure and non-compliance

22. Comment: The audit samples should not be use as evidence of non-compliance. 

The audit sample results should be used as a tool to assess the usability of the results for 

compliance purposes not the sole reason for finding a facility in non-compliance when the 

emission test may demonstrate compliance. (0014, 0015, 0020, 0022, 0023, 0026, 0027)

Response: The audit sample results can and should be used to assess the usability of the 

stack test results for compliance purposes, but those audit sample results can and should, as 

appropriate, also be used to establish non-compliance. Sources may present whatever credible 
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evidence they have to compliance officials indicating whether or not the audit sample results 

have a significant bearing on the compliance test results.

23. Comment: It is inappropriate to place compliance responsibility of a failed audit on 

the owner or operator of a source when a failure could be caused by a variety of factors, such as 

improper preparation or handling of the audit sample. (0008, 0018, 0019)

Response: While in some circumstances, the evidence would suggest that the owner or 

operator of a source is not the proper party to identify as the defendant in an enforcement action

(such as cases of improper sample dilution), there are other circumstances where this would be 

entirely appropriate (such as cases where both the audit sample and stack sample results indicate 

non-compliance with regulatory standards). Therefore, EPA must allow for that possibility

among the options. All parties who may have contributed to violations should be held 

responsible.

24. Comment: EPA should provide clear guidance in the final rule about the 

interpretation and resolution of audit sample results. The commenter gave the example of a test 

program for which the audit sample is slightly outside the acceptance criteria and the emission 

test results are twenty-five percent of the compliance limit. Clearly, outlying audit sample 

results require case-by-case determination reflecting the input of the source, the source testing 

firm, the laboratory, and the regulatory agency. (0011)

Response: EPA will make case-by-case determinations in every case before deciding to 

assess liability against any party or parties.

25. Comment: The final rule should provide a means to appeal or question a retest or 

compliance action as the result of a failed audit. EPA should provide oversight authority to 

referee such situations while one commenter suggested a procedure to require the audit sample 

be reanalyzed by the AASP. (0016, 0026, 0028)

Response: Audit samples are not the only criterion use to evaluate the quality of the test 

data; therefore, we do not expect disputes to be common. EPA believes that disputes involving 

failed audits can be negotiated by the parties.

26. Comment: Delays in obtaining audit samples due to problems with the AASP could 

result in a failure to successfully complete the required source test within the specified time. 

(0026)

Response: All parties must make the appropriate efforts to ensure that all requirements 

are satisfied on time as required. Where samples are simply not available or delayed due to 

problems in the system, compliance difficulties should be discussed with state or EPA officials 

to determine the best course of action.

27. Comment: The proposed rule does not allow flexibility for the case where the Audit 

Sample Provider(s) cannot, for whatever reason, provide the owner/operator an audit sample in 

sufficient time to meet the applicable compliance test deadline. The proposed rule unreasonably 
10

creates a legal obligation or liability for which the source owner/operator would have no control. 

We therefore request that EPA revise the proposed rule to waive the requirement for audit 

sample analysis if a) the source owner/operator requests the audit sample from an Audit Sample 

Provider no later than 30 days prior to the test date and b) if the Audit sample provider fails to 

provide the samples to the owner/operator in time to analyze the sample during the performance 

test. This language is fully consistent with language already promulgated in Section 63.7(c)(4)(i) 

and (iii), except currently the request for samples must be made to the responsible enforcement 

agency. (0020, 0027)

Response: Owners and operators should plan in advance to meet their obligations. If 

they contact the Audit Sample Provider and it is determined that more than 30 days’ advance 

notice is needed, then arrangements should be made to give sufficient advanced notice. By

eliminating EPA from the service of providing the audit samples, EPA hopes that private parties 

will do a better job of providing audit samples, to the benefit of all parties.

Reporting period

28. Comment: Reporting schedules in the final rule should be modified to include an 

additional 15 days for reporting and a tolling period of 90 days if additional testing or retesting is 

required as a result of a failed audit sample. The basic procedures and the retesting procedures 

may interfere with meeting 30 day requirements for supplying QA/QC’ed data to the compliance 

authorities. (0020)

Response: Since the purpose of an audit sample is to support the credibility of a 

particular test result, it is important that the pass/fail result of the audit sample be included in the 

final test report. By privatizing the audit program, facilities will be able to get audit results 

directly from the AASPs which will be much quicker then obtaining them from the compliance 

authorities as in the past. Since the procedure for obtaining audit results will now be quicker, the 

final rule does not include additional time to submit a final report.

29. Comment: Additional time may be needed to obtain information on how all the audit 

sample faired compared to the acceptance criteria before completing and submitting the final 

report. (0008)

Response: See the response to Comment 28.

30. Comment: EPA should delete the requirement for the final repot to include the 

pass/fail result. A second option is to delete the proposed requirement to submit “a summary of 

the emission test results” at the time when the audit sample results are initially reported to the 

compliance authority and the audit sample provider. Additional reporting steps will directly

prevent owners/operators from meeting their compliance report deadlines and/or create an 

unnecessary condition where enforcement negotiations for additional reporting time is needed 

for many compliance test. (0027)

Response: See the response to Comment 28.

Choosing correct concentration for an audit sample
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31. Comment: There is a risk that the audit samples will fail because they may not be in 

the same concentration range as the actual samples and therefore would be out of the calibration 

range of the method. EPA should consider this in the final rule. (0018)

Response: EPA does not believe this is an issue because a test sample can also turn out 

to be in a concentration range outside of the calibration range and laboratories must take steps to 

deal with the issue. 

32. Comment: The proposal does not provide for regulator input into the supplied audit 

concentration levels. This is critical. Currently, regulators request audit concentrations based on 

what they believe is applicable for a given test program. While the proposal specifies that the 

source provide an estimate of the pollutant concentration(s), there is no regulatory confirmation, 

nor the option for the regulator to make specific requests based on the needs for the given test 

program. (0010)

Response: EPA agrees that the compliance authority should have the opportunity for 

input into the supplied audit concentration level. The rule was revised to require that an 

acceptable criteria document provides the opportunity for the compliance authority to comment 

on the supplied audit concentration levels.

33. Comment: Section 60.8(g)(1) states: “When ordering an audit sample, the source 

operator, or representative shall give the sample provider an estimate for the concentration of 

each pollutant that is emitted by the source and the name, address, and phone number of the 

compliance authority.” This requirement will cause confusion because a source may or may not 

know the concentration of the pollutant of concern. Since EPA’s interest is in ensuring that the 

emission standards are being met, the requirement should be to provide information on the 

standard the facility has to meet and the concentration that would be expected in the stack gases 

if the emissions equaled the permitted level. The sample provider can then supply an audit 

sample that is within the target range for the specific pollutant. (0026)

Response: EPA agrees that the facility could provide information based on the facility 

standard or permit level instead of exact stack emissions. The sentence was revised to read 

“When ordering an audit sample, the source operator, or representative shall give the sample 

provider an estimate for the concentration of each pollutant that is emitted by the source or the 

estimated concentration of each pollutant based on the permitted level and the name, address, 

and phone number of the compliance authority.”

34. Comment: One sentence reads, “When ordering an audit sample, the source owner, 

operator, or representative shall give the sample provider an estimate for the concentration of 

each pollutant that is emitted by the source and the name, address, and phone number of the 

compliance authority.” After this sentence, EPA should insert the sentence, "The owner, 

operator, or representative shall provide the compliance authority with evidence for approximate 

ranges of expected concentrations of each pollutant to be tested." We have found that sources 

and their representatives usually provide such estimates with little or no evidence. Unless 

required, they have often not been willing to get the evidence from past tests or tests of similar 

emissions equipment. (0021)
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Response: The rule language requires them to provide such information to the audit 

sample provider. If the facility does not know the emission concentrations of interest then they

can provide information based on the permitted level. See response to Comment 33 for revised 

language allowing the information based on permitted levels.

35. Comment: When ordering an audit sample, the source owner, operator, or 

representative shall give the sample provider an estimate for the concentration of each pollutant 

that is emitted by the source...” For a given pollutant sampling time may vary from test to test. 

Instead of providing an estimate of pollutants emitted, the information provided to the AASP 

should be the estimated concentration of the pollutant collected. (0021)

Response: We believe that it is sufficient for the source owner, operator, or 

representative to give the sample provider an estimate for the concentration of each pollutant that 

is emitted by the source. The sample provider can use the estimated concentration along with the 

minimum sample volume to calculate the expected sample concentration.

EPA cost estimate is not accurate

36. Comment: The EPA cost estimates for audit samples are low. The cost will be 

more than the EPA’s estimate of approximately 1% of a source test. One commenter cited an 

example where a NELAC Proficiency Test (PT) sample initially cost $150 and quickly increased 

to over $900 for just a standard SO2 gas audit sample. (0010, 0011, 0016, 0028)

Response: The commenter did not present any evidence to support this cost and we were 

not able to substantiate the claim. According to discussions with the Executive Director of The 

NELAC Institute (TNI), the current cost range of SO2 PT samples is approximately $95 to $108 

and we expect the cost for the SO2 audit samples to be about the same because they are made 

exactly the same only used for different purposes. The cost estimates discussed in the proposed 

rulemaking are based on the last ten years that EPA has operated the program.

37. Comment: EPA needs to provide other means to get samples that will be affordable 

if the proposed means is too expensive. However EPA must not allow such an alternative to 

enable cheaper alternatives to remove enough customers that accredited providers of audit 

samples become less feasible and prices for sample from accredited providers get even higher. 

(0021)

Response: EPA looked at several different scenarios for privatizing the SSAP and 

believes the use of AASPs is the best means to ensure consistently high quality audit samples. 

EPA is willing to consider other ideas when presented with a detailed proposal.

38. Comment: EPA underestimated the cost of the audit program because they did not 

take into account the future usage rate which will be significantly more if audit sampling is 

required for all compliance testing. (0008)

Response: The cost estimates discussed in the proposed rulemaking are based on the last 

ten years that EPA has operated the program taking usage rates into account. Audit samples 

have been required for compliance testing for many years. It would be difficult if not impossible 
13

for EPA to try and guess how much if any additional demand there will be for the program. 

Even if the demand for samples increases, we still believe the cost of the samples will be 

approximately 1% of the total cost of the compliance test.

39. Comment: EPA significantly underestimated the cost of the audit program because 

EPA did not include the analytical fees associated with the audit. (0008, 0011, 0014, 0015, 

0016, 0020, 0028)

Response: The analytical fees are not a new cost. Facilities have always been required to 

pay for the analysis of the audit samples even under the current program where EPA has 

provided the audit samples free of charge. Therefore EPA does not believe it is appropriate to 

add analytical fees to the estimated cost for the program.

Should set a limit on the cost of audit samples

40. Comment: EPA must also administer and control the cost of blind audit samples and 

establish a maximum upper bound cost for each type of blind audit sample. Suggested caps are: 

$250 for gas samples, $400 for liquid samples, and $600 for metal and PBT samples. (0016, 

0028)

Response: EPA does not have the authority to set the prices that a private company can 

charge for their products.

ICR cost estimates are incomplete

41. Comment: EPA’s cost estimates and the Information Collection Request (ICR) are 

woefully incomplete. EPA’s estimate should include the total costs and burdens imposed on 

sources and the agency by the proposed new SSAP, not just the cost incurred by the AASP to 

report the true value of the audit sample. The burden estimate should include, among other 

things, the cost to sources of purchasing audit samples, analyzing (and in some cases 

reanalyzing) audit samples, reporting audit sample results and other information, developing and 

implementing the other aspects of the proposed “external QA program,” and participating 

initially and every two years thereafter in the proposed VCSB “public process” to ensure that 

criteria developed by those organizations are reasonable. The burden estimate also should 

include the cost to EPA of reviewing and approving proposed “written technical criteria 

documents” and otherwise participating in the process.

EPA’s suggestion that it’s ICR is limited to that one task because it is the only “new” 

requirement under the proposed restructuring is misplaced. EPA could only lawfully limit its 

estimate to this new requirement if the other burdens already were covered under an approved 

ICR for the period in question. But, as far as UARG can tell, EPA has never submitted, let alone 

received approval of, another ICR related to the SSAP. As a result, EPA cannot exclude those 

costs nor can EPA exclude the additional costs associated with its proposed expansion of the 

program. (0024)

Response: The ICR estimate of burden includes the estimated cost for the AASP to 
14

report the results of the audit to the compliance authority. In addition, the ICR has been revised 

to include the cost of the audit sample since in the past the audit samples were free. The cost of 

the requirement to analyze (and in some cases reanalyze) audit samples and reporting audit 

sample results has already been taken into account in past ICRs for each emission limit under the 

New Source Performance Standards which contained a burden estimate for reporting emission 

testing results to demonstrate compliance with emission limits. EPA believes that not all 

compliance tests that should be audited are being audited under the current program. We believe 

under the restructured program the rate of compliance with the audit requirement will be higher; 

therefore, we have revised the ICR to reflect the fact that more audit samples will be purchased. 

The final rule does not require anyone to participate in the VCSB “public process” and therefore, 

the cost of participating was not included in the ICR.

Requiring same analyst and analytical system for sample analysis

42. Comment: We are concerned about the proposed requirement that the audit sample 

must be analyzed by the same analyst using the same analytical reagents and analytical system as 

the compliance samples. We anticipate that the off-site laboratory will have a number of 

different analysts using the same type of equipment. For example, there may be several gas 

chromatograph/mass spectrometry instruments in a particular lab. All of these instruments are 

calibrated and certified. For all practical purposes, it does not matter which of these instruments 

are used to analyze an individual sample. All should give the same answer. (0015, 0023)

Response: While EPA agrees that identical instruments calibrated by the same reagents 

should give the same answer within repeatability limits, EPA also believes that it is important to 

limit all sources of imprecision and; therefore, the audits should be analyzed using the same 

analyst and the same analytical system as the compliance test samples.

43. Comment: The requirement that the audit sample must be analyzed by the same

analyst using the same analytical reagents and analytical system as the compliance samples” 

should be expanded to specify analyzing them with the batch of compliance samples in the same 

batch and, if they are collected in the field, to collect them with the same person(s), using the 

same reagents and collection system. An example could be, “The audit sample must be 

collected, if it is an audit sample collection, and analyzed with the compliance samples by the 

same persons using the same field and analytical reagents, sampling and analytical systems, and 

procedures as for the compliance samples. Collection with the compliance samples means at the 

same location immediately before, after, during, or between test runs collecting compliance 

samples.” If field testers use different sampling trains to collect compliance samples during 

different test runs, the question could arise how to fulfill this requirement, aside from collecting 

the sample with all the trains and analyzing the samples from the different trains separately or as 

a composite. This appears to be the best practice. If there is a defect or contaminant in one train, 

the audit will not detect it unless it uses that train to collect the audit sample. (0021)

Response: The final rule was revised to clarify how field audits should be collected when 

the audit sample is designed to check the sampling system. The final rule requires that field 

audits must be collected using the same field testing person who collected the field samples 

using one of the field sampling systems that was used to collect the compliance samples. If 
15

multiple sampling systems were used, the rule does not require that each sampling train used 

during the field test be used to collect an audit sample. The revised rule also requires that the 

audit samples must be analyzed at the same time as the test samples unless the compliance 

authority waives this requirement.

44. Comment: We have concerns with EPA’s premise in it’s fact sheet that suggest audit 

samples must be analyzed alongside test samples in order for the regulatory agency to approve 

the compliance results. This approach could create uncertain and invalid source test results. 

(0008)

Response: EPA does not understand how analyzing the audit sample along side the test 

samples could create uncertain and invalid source test results. The audit samples contain the 

same pollutants in the same matrix as the source test samples and should be analyzed in the same 

manner as the sources test samples. 

When are audit samples required?

45. Comment: It makes more sense for the company and the compliance authority to 

discuss the need for an audit sample on a case-by-case basis instead of EPA making it mandatory

for each individual test. (0019, 0023)

Response: The requirement for an audit sample is nothing new. Current regulations 

require audit samples if they are available and we do not see a need to change this requirement. 

We believe that the program should be administered consistently across the Nation and the only 

way to do that is to require the tester to include an audit sample with all compliance tests using 

methods for which audits are available. The compliance authority can always waive the 

requirement to include an audit sample for a specific compliance test if they believe the audit 

sample is not necessary.

46. Comment: EPA's proposed regulatory text is not clear with respect to how many 

audit samples may be required during a given performance test. If the same method is used and 

same pollutant is sampled, only one audit sample should be necessary for the entire set of 

samples collected during a test program. EPA should clarify in the final rule to require one audit 

sample per method per testing activity regardless of the number of individual test runs. (0010, 

0011, 0023, 0027)

Response: EPA agrees that only one audit sample per method used during a performance 

test is needed so long as all pollutants measures using that method are covered by the audit 

sample. We have clarified this in the final rule.

47. Comment: Requirement to analyze audit samples should be limited to no more than 

three performance tests (i.e., three test methods per performance test). Otherwise an authority

could require audit samples for every pollutant, every run, and every test condition, going well 

beyond the spot check on accuracy of the performance test that EPA envisions. (0016, 0028)
16

Response: EPA does not agree that the audit samples should be limited to no more than 

three performance tests although we did clarify in the rule that only one audit sample per method 

used during a performance test is needed so long as all pollutants measures using that method are 

covered by the audit sample.

48. Comment: We hope that it is EPA's intent for delegated agencies to also have some 

discretion over the audit program implementation since it will be included in the reference 

method language. We foresee specific problems when facilities are performing multiple test 

methods and are required to obtain audit samples for each method. We recommend that state 

and local agencies be permitted to have discretion in determining how many audit samples are 

required for each testing situation. (0013)

Response: This rule in no way changes a delegated agency’s discretion in implementing 

the audit program as it currently stands. We did clarify in the rule that only one audit sample per 

method used during a performance test is needed so long as all pollutants measures using that 

method are covered by the audit sample.

Audit sample availability

49. Comment: Timing for checking on availability of a specific pollutant audit sample 

does not mesh with the 60 day requirement to submit a test protocol for approval by the 

permitting authority. Cut-off date for sources to locate and incorporate audit sample 

requirements into a performance test plan must be at least 3 months prior to submitting the test 

protocol to their permitting authority. (0016, 0028)

Response: There is no requirement under the amended SSAP program to submit a test 

protocol for approval by the compliance authority. If a source chooses to voluntarily prepare and 

submit a test protocol, the protocol could incorporate audit sample requirements that would have

to be met only if an audit sample became available 60 days prior to the scheduled test date.

50. Comment: The restructured audit program must have a mandatory requirement that 

there will be more than one provider of each type of audit sample (gas, liquid, metal) in order to 

have healthy competitive pricing and alternative sourcing. Program requirements for a specific 

type of audit sample should not be effective until after clear demonstration of at least two 

qualified U.S. sources for the type of auditsample. (0016, 0023, 0026)

Response: EPA agrees that there needs to be at least two sources of an audit samples 

before it is considered commercially available. Also see response to comment 18.

51. Comment: If audit samples are ultimately required for each test, we suggest that 

each test plan should clearly indicate how the facility intends to comply with this requirement 

during the test event. There would be no need to specify which AASP will provide the audits. 

Conditional language in the approved plan could protect a facility from unexpected 

unavailability of an audit sample. For example: Audit samples will be provided for the following 

test methods [list of methods] provided such audits are available from an accredited provider. In 

the event audit samples are not available for one or more test methods from an accredited 
17

provider, the Permittee will notify the Administrator within 60 days of testing that a method 

audit sample is not available for one or more methods from an accredited provider and no audit 

sample will be provided for the subject method in accordance with [insert regulatory citation]. 

(0015)

Response: Except for the existing rules in Part 63, there is not requirement for a test 

plan. Sources may choose to submit a test plan under Parts 51, 60 and 61. Whether the test plan 

submitted is required or not, EPA agrees that test plans do not need to specify which AASP will 

provide the audit samples, so long as AASPs being considered are listed in the plan.

52. Comment: EPA presumes that there will be AASPs or Accredited Proficiency Test 

Sample Providers willing to get in the business of supplying the necessary audits for all 

applicable methods. What if this is not the case for some or all of the methods? Are there plans 

for a transition period if there is a delay in getting Providers accredited? If audit materials 

become unavailable, an important quality assurance tool of the Regulators will be lost. (0010)

Response: We anticipate that audit samples will be available for most if not all the 

methods for which EPA currently provides audit samples. We know that TNI is currently

developing criteria documents and accreditation standards to produce audit standards 

(www.nelac-institute.org/standards.php) so we know there is interest in the private sector. We 

believe there will be an accredited audit program in the future. Therefore, we do not believe that 

there is a need for a transition period during which EPA would continue to provide audit samples 

until an AASP is approved. Again, if an audit sample is not available, there is no requirement 

for use of an audit sample.

53. Comment: The proposal does not deal with kinds of audit samples that accredited 

providers choose not to provide. They will not provide samples that cannot be sold for a profit. 

The EPA should add to the rule allowance of other ways to obtain samples when they are not 

available through accredited providers. (0021)

Response: EPA cannot require an AASP to provide all types of audit samples. EPA 

looked at several different scenarios for privatizing the SSAP and believes the use of AASPs is 

the best to ensure consistent high quality audit samples. EPA is willing to consider other ideas 

when presented with a detailed proposal. 

54. Comment: The EPA document uses language such as “if available” and “if no gas 

phase audit samples are available” which indicates that it is anticipated that audit samples may

not be available, and that it is unclear which audit samples would need to be performed with each 

method. (0007)

Response: EPA believes audit samples will not be available for all methods for which 

audit samples could be applicable as is with the current program therefore the phrase “if 

available.” is used. It would not be reasonable to require audit samples knowing some may not

be available for purchase. The only method that currently has a gas audit sample is Method 25 

and we do not foresee any other gas audit samples in the near future. We will post on the EPA 
18

web site listed in the rule what audit samples are available and in what format (gas, filter, etc.) 

they are available.

55. Comment: Under EPA’s proposed new SSAP, notice of availability of audit samples 

would be the sole means of determining whether a test method requires use of an audit sample. 

All test methods would require audit samples unless EPA’s website does not identify a provider 

60 days before the test. Sources would have to check EPA’s website prior to every performance 

test to determine whether a new requirement might apply. We object to this use of the 

availability criterion. Whether an audit sample is required should be based on a determination, 

made after notice and comment rulemaking, that analysis of an audit sample is appropriate for a 

particular test method and not on whether EPA determines that a sample is “available” 60 days 

before a test. to promulgate the provision as proposed, EPA would have to explain why analysis 

of audit samples is appropriate for all existing and future test methods in Parts 51, 60, 61, and 63, 

once EPA determines that an audit sample “is available” from a private provider. EPA has not 

done that. (0024)

Response: As previously discussed in this rulemaking, EPA believes that the use of audit 

samples is appropriate and provides an important tool in compliance testing for all test methods 

in Parts 51, 60, 61 and 63. EPA has not been presented with adequate evidence to the contrary in 

this rulemaking. Therefore, EPA continues to believe that audit samples are a useful tool. EPA 

disagrees with the commenter that availability of a new audit sample creates a new requirement. 

Under this rulemaking, all test methods require audit samples, except where a sample is not 

available. A new audit sample becomes available once there are two providers willing to supply 

the audit sample. The criteria for accredited sample providers have been outlined in this 

rulemaking for notice and comment.

56. Comment: PT samples should not be used in place of audit samples, unless PT 

Providers follow the Provider requirements and be accepted as an Audit Sample Provider by a 

Provider Accreditor, as set forth in the Standards defined by the VCSB they are using. There are 

many differences between Audit Sample and PT Sample standards with respect to ordering,

reporting, and analyte concentration ranges, to name a few. If audit sample protocols are not 

followed, the usefulness of the data may be diminished. Additionally, if PT Providers can 

participate in the audit sample program without having to comply with the same standards as 

Audit Sample Providers, there will be no incentive for PT Providers to become Audit Sample 

Providers. (0012)

Response: We agree with this comment. The rule has been revised to remove the option 

of using PT samples in place of audit samples if audit samples are not available.

57. Comment: Gaseous sample audits: We perform numerous test programs for gaseous 

components (NOx, CO, SO2, HC). We have been concerned with the lack of availability of audit 

samples currently, and would like more detail regarding the type and availability of audit 

samples proposed for gaseous measurements. (0007)
19

Response: Currently the only gas audit sample available is for Method 25 and we do not

foresee any other gas audit samples in the near future. We will post on the EPA website listed in 

the rule what audit samples are available and in what format (gas, filter, etc.) they are available.

58. Comment: The EPA should not allow sources to forgo using an audit sample if the 

EPA fails to identify a provider on its website 60 days before a scheduled test. The EPA should 

limit its informational obligations to informing users how to find information about approved 

audit-sample programs and leave the job of identifying providers and which samples are 

available to these programs. (0021)

Response: It takes time to plan and prepare for a source test. We do not want a source to 

be cited for a violation because an audit sample becomes available a short time before the 

compliance test. We also do not want sources and testing firms to spend time everyday looking 

for available audit samples. Therefore, we believe the final rule needs to provide a 60 day time 

frame so that sources can properly plan a compliance test. In addition, listing the available audits 

on our website not only benefits the sources but also the compliance authorities. The list 

provides one location for them to see what is available otherwise they too would have to 

constantly contact providers for information on available audits.

Setting acceptance limits

59. Comment: EPA is relying too much on voluntary consensus organizations to do the 

job of enhancing data quality. A VCSB should not write standards with regulatory compliance 

implications without EPA first establishing the acceptability criteria or defining how the 

acceptability criteria should be established. For example, prior to sending out audit samples, an 

organization needs to conduct interlaboratory tests to determine the acceptable error range. EPA 

needs to define its minimum requirements to set regulatory limits and not leave it up to voluntary

consensus organizations to define the acceptable level of performance for compliance purposes. 

(0026)

Response: We agree that EPA needs to define minimum requirements for how the 

acceptance criteria should be determined in the final rule. The final rule has been revised to 

specify that acceptance criteria must be based on results from the analysis of audit test samples 

analyzed by qualified laboratories using the method that is being audited. The final rule requires 

that acceptance limits must be set so that 90 percent of qualified laboratories would produce 

results within the acceptance limits for 95 percent of all future audits. This acceptance criterion 

is consistent with the general goal that EPA established for the program it operated in the past.

60. Comment: The rule should assign responsibility for planning and carrying out 

research, development, review, maintenance, and improvement of the specifications for audit 

samples for each test method to the VCSB overseeing accrediting of audit-sample providers. 

The proposed rule assigns this responsibility to each provider separately. (0021)

Response: EPA does not believe the proposed rule assigns research, development, 

maintenance or improvement to anyone specifically. The proposed rule does state that the audit 

sample providers in consultation with the VCSB should periodically review the acceptance 
20

criteria for each audit sample. Since EPA is defining “commercially available” as at least two 

sources it would be inadvisable for one provider to work alone, not to mention that the providers 

must be accredited to provide each individual sample and the criteria for accreditation must be 

approved under the umbrella of the VCSB. This means that the procedure and requirements 

must be reviewed and approved by the VCSB.

61. Comment: “Evaluating the acceptance limits of samples at least once every two 

years to determine in consultation with the VCSB if they should be changed.” The purpose of 

the audit program is to evaluate data quality for tests used to determine compliance with 

governmental regulations. The rule should require that agencies with compliance authority have 

a significant role in determining the acceptance limits of the audit samples. (0021)

Response: Although EPA thinks it is a good idea for compliance authorities to 

participate in standard development process, we do not have the authority to require other 

agencies to participate in VCSB. EPA retains the authority to adopt additional regulatory criteria 

through rulemaking for the audit program if it is determined in the future it is needed.

62. Comment: EPA proposes to eliminate provisions in existing test methods that 

identify the criteria for determining acceptability of the PA sample result. Instead, the rule 

would state only that an audit sample fails if it does not produce “an acceptable result.” 

Proposed §60.8(g). Acceptability of results would be determined, not by rule (or even by EPA), 

but by the AASP or APTSP “in cooperation with” some “VCSB.”. Like the existing test 

methods, and §63.7(c), the proposed rule would specifically allow the regulatory authority to use 

the sample results to determine the compliance status of the source. Proposed §§60.8(g) and 

60.8(g)(2)(vi). EPA’s proposal to allow third party organizations to unilaterally establish (and 

periodically revise) the acceptance criteria for audit sample results, and therefore, the compliance 

status of sources, is unlawful. Sources are entitled to notice and opportunity for comment on 

revisions to the standards that establish their compliance. To the extent EPA believes that the 

current criteria for acceptability are no longer appropriate, EPA must explain why and propose 

new criteria. If a VCSB in the future establishes criteria for acceptability of audit results for 

particular test methods that the Agency deems appropriate, EPA can conduct a future rulemaking 

to propose incorporation of those criteria rather than develop its own. The opportunity to 

participate in a future proceeding by some VCSB is not a lawful substitute for a rulemaking 

proceeding on a determination of acceptability by EPA. (0024)

Response: EPA is not allowing third party organizations to determine the compliance 

status of sources. Third parties are simply providing audit samples. These samples are not used 

to determine compliance or even revise standards. They are quality assurance tools that may be 

used by the compliance authority as evidence of compliance or non-compliance. All audit 

sample providers are required to meet certain criteria in order to provide samples. These criteria 

have been provided for notice and comment.

63. Comment: We have concerns regarding EPA’s proposal for AASPs, TNI’s standard 

for PT providers contains inappropriate criteria for development and adoption of acceptance 

criteria. Specifically, the TNI standard provides a group of TNI appointed members (called the 

TNI PT Board) sole, and apparently unlimited, authority to develop acceptance criteria, which 
21

then are simply published in Tables on the TNI website and applied by PT providers. See, e.g., 

Volume 3, sections 6.3.1, 10.2.1, and 10.3.1. Contrary to EPA’s proposed criterion in 

§60.8(g)(2)(vi), this particular standard does not appear to provide for review of, or vote by the 

TNI membership on, audit sample acceptance criteria, let alone require consensus on them. As a 

result, the standard not only allows establishment of acceptance criteria that could be critical to a 

source’s compliance without rulemaking, it provides for their establishment without any public 

participation. Thus, even if these TNI standards are relevant to the proposed new SSAP, they

should not be incorporated unless that unlawful aspect of the standards is removed or revised. 

(0024)

Response: See response for comment 59.

64. Comment: EPA must address regulatory, or even peer-reviewed criteria, established 

by the proposed rule for determining the “true value” and/or acceptable range for the audit 

sample results, which under the proposal apparently would be left up to either the third-party 

AASP or the fourth party audit sample provider accreditation. The proposal also does not 

indicate for the respective Reference Methods, what the QA/QC objective is for the audit sample. 

The proposal is deficient without delineation and a basis for establishing such a standard. 

Further, we submit that the proposal also should address means for assuring that audit samples 

are properly analyzed or prepared or handled during shipping as well as “ownership” of the 

sample once received, a critical element in reporting and further analysis if there is audit sample 

failure. (0020)

Response: The criteria for determining the true value and acceptance limit are not 

determined by the AASP or the audit sample provider accreditor (ASPA) but by the VCB. The 

technical criteria documents specify how the samples are to be prepared, analyzed and shipped. 

It is the responsibility of the ASPA to check the AASPs to make sure they are complying with 

the criteria document procedures. The criteria documents are approved in advance by EPA. The 

audit samples are owned by the facility once they are received.

Audit samples should not apply to instrumental methods

65. Comment: EPA has not explained how a test method PA would apply to 

instrumental test methods, to test methods involving human observers (i.e., Methods 9 and 22), 

or to any of the other test methods that currently do not include audit sample requirements. The 

instrumental test methods already include QA requirements and specifications for accuracy of 

the required calibration gases, and EPA never suggested in any of the recent revisions that use of 

blind audit samples should be required for those methods. For calibration style reference 

method, it is both duplicative and unnecessary to add a step to the current audit sample analysis 

process. (0008, 0024)

Response: We agree that it is not necessary to require audit samples for those test 

methods that use instruments that measure pollutants in the stack gas taken directly from the 

source. These methods include Method 3C, 6C, 7E, 10, 20, 25A, 318, 320, and 321. These 

methods already have sufficient calibration and quality assurance requirements that would make 

an additional audit sample redundant. We believe that Method 18 also has sufficient quality 
22

assurance measures that make an audit sample unnecessary. This method requires that the tester 

perform a recovery study through the entire sampling system to demonstrate that the combined 

sampling and analytical system is capable of measuring the target pollutant within specified 

limits. The measured results are then corrected to account for the empirically determined 

recovery. We believe that for this method an audit sample would not add significant additional 

information about the quality of the measured results. We have revised the final rule to 

specifically exempt Methods 3C, 6C, 7E, 9, 10, 18 20, 22, 25A, 303, 318, 320, and 321 from the 

requirement to have an audit sample. We also agree that Methods 9, 22, and 303 do not need 

audit samples. These are all methods for determining visible emissions by observation and, 

therefore, there is not practical way to audit them. The final rule has been revised to exempt 

these methods from the audit sample requirement.

66. Comment: We question the need to conduct audits on routine test such as SO2, NOx, 

VOC and others since these tests require the use of certified standards to calibrate and validate 

results. Mandating audits samples for any and all routine testing performed under the qualifying 

air programs is redundant and unnecessary. (0014)

Response: See the response to Comment 65. We agree that Methods 6C, 7E and 25A 

which are the methods that measure SO2, NOx, and VOC using certified calibration gas standards 

do not require audit samples. We have revised the final rule to exempt those methods from the 

general requirement to include audit samples.

Notice and comment procedure

67. Comment: EPA’s proposal, and in particular its proposed use of VCSBs, has many

problems. First, EPA’s proposal turns the requirements of the “National Technology Transfer 

and Advancement Act of 1995” (NTTAA) (Public Law 104-113) on its head. The NTTAA 

requires EPA (and other federal agencies) to use standards already adopted by VCSBs, where 

appropriate, rather than developing their own government-unique standards, and to participate in 

the development of such standards to help ensure their usefulness in government applications. It 

does not authorize EPA to adopt Voluntary Consensus Body (VCB) standards that do not 

currently exist, to adopt rules that condition sources’ compliance with Federal regulations on a 

VCSB’s adoption of standards, or to require regulated sources to participate in future VCSB 

proceedings in order to protect their interests.

EPA’s own regulations regarding incorporation of standards by reference prohibit 

incorporation of future standards. See, e.g., 40 C.F.R. §51.3. EPA’s proposal of a rule 

specifically designed to allow EPA to approve and incorporate by reference future VCB 

standards is an unlawful circumvention of notice and comment procedures, and of limitations on 

incorporation by reference. EPA’s proposed rule is no more lawful than a rule authorizing the 

Administrator to incorporate by reference without further rulemaking any future voluntary 

consensus standard EPA deems appropriate. (0024)

Response: The NTTAA only requires agencies to use VCS in regulatory actions when 

VCSs are available. There are no current standards adopted by VCSBs for audit samples. We 

are allowing VCSBs to develop standards for audit samples and allowing these standards to be 
23

used for government applications. These audit samples are not used to determine compliance. 

They are quality assurance tools used during compliance testing to assist in determining the 

accuracy of the compliance testing. The final rule does not condition a source’s compliance with 

Federal regulations on a VCSB’s adoption of standards. If audit samples do not exist for a 

particular compliance test, an audit sample is not required. There is also no requirement that 

sources participate in future VCSB proceedings. Sources may participate, but there is no 

requirement.

On the second point, we did not circumvent notice and comment procedures. The final 

rule establishes minimum requirements for the audit samples, the AASPs and the AASPA. We 

have proposed these criteria for notice and comment. Although audit samples may be produced 

in the future, the only audit samples that we will accept are those that meet the substantive 

requirements of this rule. Accordingly, all commenters have had a full opportunity to discuss 

their concerns with the requirements set for audit samples by this rule.

68. Comment: We understand through our own research that EPA approached TNI more 

than a year ago regarding the development of standards that could be used to privatize the SSAP 

in a manner similar to what EPA now proposes. In July 2008, TNI developed, and for a full year 

EPA staff participated on, a committee for the express purpose of “developing TNI consensus 

standards that enable the externalization of EPA’s SSAP.” We assume EPA hoped that TNI 

would be able to adopt standards consistent with the criteria EPA now proposes for the AASP 

and ASPA “written technical criteria documents” in time for EPA to simply propose that those 

adopted TNI standards be incorporated by reference. That did not happen. TNI had not even 

completed the voting process on the TNI “Stationary Source Audit Sample” (SSAS) 

Committee’s draft standards when EPA issued its proposal. As a result, EPA moved forward 

with a proposal that, without even identifying TNI or the draft SSAP standards, appears 

specifically designed to preauthorize EPA to approve and incorporate by reference those 

standards if they are adopted by TNI. Rather than discuss the TNI standards in the rulemaking, 

EPA asked the public to “identify potentially-applicable VCS” and explain why they should be 

used in EPA’s rule. To the extent EPA was suggesting by its solicitation that it might 

incorporate into the final rule standards, like the TNI standards, identified by commenters, we 

object. Although the Agency has some discretion to alter its final rule in response to comments, 

these standards are not an insignificant part of the proposal. They are the entire reason for it. 

EPA cannot revise its final rule to incorporate such an important element without identifying and 

soliciting comment on it. (0024)

Response: See response to Comment 67.

69. Comment: To the extent EPA wants to adopt the TNI SSAS Committee standards, if 

and when they are finalized, EPA will need to develop a new rulemaking proposal that names 

those standards, describes any relevant issues raised by those standards, and describes the extent 

to which those standards have resulted in the availability of sufficient AASPs and ASPAs to 

implement EPA’s proposed program. We, specifically, request that any such proposal include in 

the docket a copy of the tally of votes by the TNI membership on the proposed TNI SSAS 

standards, a copy of any negative votes received, and a description of how those votes were 

resolved. In our experience, many standards adopted by VCSB do not generate significant 
24

comment among the VCSB membership and may be developed and adopted by a very small 

group of individuals with a fairly narrow range of interest. For this reason, adoption by a VCSB 

is not itself a substitute for rulemaking. VCSB standards must be incorporated through 

rulemaking before their terms can be imposed on regulated sources. (0024)

Response: EPA does not believe that VCSB standards must be incorporated through 

rulemaking. EPA has established regulatory criteria for VCSBs. EPA will only approve a 

VCSB criteria document if it meets all of the requirements in the rule. The NPRM for this 

rulemaking provides for comment on those criteria.

70. Comment: We object to EPA’s incorporation of the two existing TNI standards 

addressing PT providers. EPA has not sufficiently explained how these standards, which address 

development and evaluation of PT samples used to evaluate laboratories seeking accreditation, 

would apply to the SSAP EPA proposes. Incorporation simply to provide an “example” of a 

standard that meets EPA’s criteria is not appropriate. (0024)

Response: EPA provided the TNI standards addressing PT providers as an example of a 

criteria document that meets EPA’s regulatory criteria for audit sample providers. The standards 

will not be incorporated into the rulemaking.

71. Comment: The Clean Air Act requires that the revision of any standard of 

performance under sections 111 and 112 of the Act require rulemaking. See §307 (1)(B), 42 

U.S.C. §7607(1)(B). This includes procedures for measuring compliance with standards and 

includes changes to methods for determining compliance. Although the proposed rule discusses 

third-party field sampling and laboratory accreditation procedures, details on these procedures 

are not part of the rulemaking. EPA proposes in the future to post a list of purveyors, but does 

not set forth procedures for certifying these providers. The NPRM does propose to incorporate a 

number of voluntary consensus standards; however, it is not clear how these standards will be 

applied, monitored or certified. We do not believe that working under voluntary consensus 

standards that are not part of a regulatory procedure is sufficient to provide the requisite 

oversight or assurances that are required as part of a regulated performance testing requirement. 

Such procedures themselves require rulemaking under law. (0020)

Response: This rulemaking does not change procedures for measuring compliance with 

standards or change methods for determining compliance. Audit samples are being used just as 

they were used in the past. They are not used to measure compliance with standards. As 

discussed previously, audit samples are used with compliance tests as a quality assurance tool.

Field analysis of audit samples 

72. Comment: The proposed changes to the Appendix M to Part 51 and the General 

provisions (60.8, 61.13, and 63.7) contain the following regulatory text for field testing: "If the 

method being audited is a method that allows the samples to be analyzed in the field and tester 

plans to analyze the samples in the field, the tester may analyze the audit samples prior to 

collecting the emission samples provided a representative of the compliance authority is present 

at the testing site". The rule should allow the owner/operator to obtain a waiver from the 
25

requirement to have the compliance authority present at the testing site on a case-by-case basis. 

It may not be practical for a representative from the compliance authority to be on-site for every

one of these audit analyses. (0015, 0023)

Response: We agree that it may not be practical in all cases for a representative of the 

compliance authority to be present when an audit sample is analyzed in the field, so we are 

revising the final rule to allow the owner/operator to obtain a waiver from the compliance 

authority for the requirement to have the compliance authority present at the testing site.

73. Comment: Is it reasonable to expect that a regulatory agency person will show up 

prior to the actual stack test just to watch the analysis of an audit sample? If that is not the case, 

will the results of the audit test be acceptable to all the parties? (0026)

Response: See the response to Comment 72.

74. Comment: EPA proposes to specifically allow reporting of audit sample test results 

prior to collecting emission samples. Proposed §60.8(g)(1). However, if “the method” allows 

samples to be analyzed in the field and the tester plans to do that, EPA proposes to allow analysis

of the audit samples “prior to collecting the emissions samples” only, if a representative of the 

compliance authority “is present at the testing site.” Id. EPA does not provide any explanation 

for this provision and we do not understand it. First, we assume EPA is referring to methods that 

allow analysis of emissions samples in the field. We also assume that by “testing site,” EPA is 

referring to the emissions source being tested. We do not understand, however, why the 

presence of a state, local, or EPA observer during source testing is necessary to authorize 

analysis of audit samples prior to source testing. We also believe that conditioning validity of 

testing on the presence of a regulatory observer is not reasonable, given that sources have no 

control over whether or not an observer shows up. In short, EPA also needs to better explain this 

aspect of the proposal. (0024)

Response: See the response to Comment 72.

75. Comment: We believe that the proposal to restrict when the tester may analyze an 

audit in the field is unnecessary (74 FR 28456). The proposed rule requires the use of blind audit 

samples so it is unclear why the agency apparently presumes that the tester (or owner/operator) 

would somehow “cheat” in determining the audit sample concentration. This provision should 

be deleted. (0027)

Response: See the response to Comment 72.

Audit sample matrix

76. Comment: There are no requirements regarding method interferents that may or may

not be added to the audit sample to make it reflective of the source being tested. The proposal 

only speaks of gaseous audits in air or nitrogen, or audits in the same matrix (undefined) 

produced after sample recovery, either of which might not be representative of stack samples. 
26

Some Providers may decide to include interferents, while others may not. This, among other 

things, leads to concerns regarding the consistency of audits between Providers. (0010)

Response: The term sample matrix was not intended to imply that the audit samples were 

to be prepared in a manner that would duplicate an emission gas stream. The term matrix was 

only used in conjunction with those samples that did not consist of the pollutant in the gas phase 

in air. The term matrix was used to indicate that if a method collected the pollutant in an 

aqueous solution, then the audit sample should consist of the pollutant in an aqueous solution. 

The EPA believes that preparing audit samples in a matrix that would include interferents that 

might or might not be present in the stack is too complex to be workable and is not requiring that 

interferents be included in the audit samples.

77. Comment: The EPA must specifically require any acceptable audit-sample program 

to strive to include in audit samples realistic interferences that may be present in emissions 

tested. The audit sample must audit the measurement of analyte concentrations in emissions as 

realistically as is feasible, including the challenges that may make measurements of field samples 

less accurate than measurements of clean lab samples. This applies to audit samples in any

container and matrix. The proposal does not interpret “matrix.” It seems to mean only the 

largest components of emission samples. (0021)

Response: See the response to Comment # 76.

78. Comment: The desire to have audits in the sample matrix is troubling. The provider 

is not necessarily going to know what to mimic, and a difference might give you misleading 

thoughts about the sample validity. Audit samples are better kept clean and analyzed as an 

'absolute' measure of the lab's accuracy in analyzing/measuring the compounds per the 

method(s). (0021)

Response: See the response to Comment # 76.

Audit results reporting and availability 

79. Comment: EPA should share the results of the audit program with the affected 

community. The commenter believes the data collected over the yeas would be helpful in 

identifying problem area and developing programs to address them. (0026)

Response: Under the current audit system, we cannot release the true value of the audit 

samples because it could compromise the integrity of the audit system. The current supply of 

data can be release to the affected community when the EPA is no longer sending out samples 

and all outstanding sample results have been reported.

80. Comment: We believe the regulatory agency should be provided a copy of the audit 

results at the time of shipment from the sample provider. Many times having the results prior to 

sample analysis helps generate more accurate data and minimizes problems. (0017)
27

Response: EPA believes that this would be beneficial, but should not be mandatory.

Since we did not provide the compliance authorities with the actual concentrations under the 

current audit program it is hard to justify making it mandatory.

81. Comment: Section 60.8(g)(1) states: “If the method being audited is a method that 

allows the samples to be analyzed in the field and the tester plans to analyze the samples in the 

field, the tester may analyze the audit samples prior to collecting the emission samples provided 

a representative of the compliance authority is present at the testing site. The source owner, 

operator, or representative may report the results of the audit sample to the compliance authority 

and report the results of the audit sample to the AASP or the APTSP prior to collecting any

emission samples.” It seems to us that if the results of the audit are available prior to conducting 

the emission tests, the facility should be provided with information on the pass/fail status of the 

audit test results prior to carrying out the source test. This would avoid unnecessary testing and 

waste of resources when the ability of the testing outfit is in question. (0026)

Response: EPA agrees with the commnenter and there is nothing in the rule to prevent

this scenario.

82. Comment: Section 60.8(g)(3)(vii) requires AASPs or APTSPs to maintain “a 

database, accessible to the compliance authorities, of results from the audit that shall include the 

name of the facility tested, the date on which the compliance test was conducted, the name of the 

company that analyzed the compliance samples including the audit sample, the measured result 

for the audit sample, the true value of the audit sample, the acceptance range for the measured 

value, and whether the testing company passed or failed the audit.”

It is our view that the results being discussed are being obtained as a part of an EPA 

regulation and should be available to the public. Keeping this information secret from source 

operators is inappropriate. The language in this section should be changed to read as follows: 

“Maintaining a database, accessible to the public and the compliance authorities, of results from 

the audit that shall include the name of the facility tested, the date on which the compliance test 

was conducted, the name of the company that analyzed the compliance samples including the 

audit sample, the measured result for the audit sample, the true value of the audit sample, the 

acceptance range for the measured value, and whether the testing company passed or failed the 

audit.” (0026)

Response: EPA disagrees that this information is being keep secret from the source 

owner or the public. The source owner will receive a report from the AASP with all the 

information pertaining to their audit(s). Giving sources full access to the database would 

compromise the audit program since true values of audit samples could be know a head of time.

83. Comment: The results shall include ... the measured result for the audit sample, the 

true value of the audit sample...” Only pass/fail should be reported. The samples are to be 

unknowns; if the audit samples are supplied in a limited number of concentrations then, over 

time, revealing the true value will comprise the unknown status of the audit sample. (0021)
28

Response: EPA agrees that the sample’s true value needs to remain blind to the sources and 

laboratories at least until the values are reported. The rule has been revised to state that only

pass/fail results will be reported unless the AASP ensures that no laboratory receives the same 

sample twice.

84. Comment: The audit sample provider would be under no compliance (or contractual) 

obligation to provide a quick turnaround on the audit results, so significant delay could occur 

during this step, depending on the audit sample provider’s availability. We believe EPA would 

need to add a regulatory provision requiring the audit sample provider to send out the results of 

the audit within 7 calendar days. (0027)

Response: EPA agrees that it is important that the AASPs provide a quick turnaround of 

the audit results. The final rule will include a criterion that AASPs submit the results in a timely

manner. The AASPs and the sources may decide a more specific time frame.

85. Comment: EPA’s proposed reporting requirements are overly complicated and 

duplicative. Sources conducting “performance test” already are required by rule to report the 

results of those test to the appropriate regulatory agency. See, e.g., 40 C.F.R. §§60.8(a), and 

60.51Da. To the extent analysis of an audit sample is required for a particular test method, the 

results of the source’s analysis (including whether the result passed or failed the acceptance 

criteria) should be included in that report. EPA provides no justification for requiring separate 

reporting of audit sample results or their acceptability to the regulatory agency or the sample 

provider. Once the sample analysis is complete, sources should be able to communicate with 

audit sample providers directly to learn the true value of the sample and calculate the pass/fail 

result to be included in the performance test report that is sent to the regulatory authority. We 

can think of no reason why the regulatory authority would need (or want) to receive results prior 

to that time. We also object to a rule that suggests the audit sample providers could provide 

audit sample results to a regulatory agency before providing them to the source that purchased 

the sample.

If EPA has specific reasons for the content and timing of the reporting provisions it 

proposes, EPA needs to explain those reasons and solicit comment on them. Otherwise, EPA 

should revise its proposal to include in the general provisions a requirement that all of the 

information necessary to document the results of the audit sample analysis required in a 

particular test method be included in the final “performance test” report submitted to the 

regulatory authority (0024)

Response: The requirement to report the audit sample results to the compliance authority

prior to the final test report is to insure the integrity of the audit system. The compliance 

authority must know the testers results for the audit system prior to the tester receiving the true 

value of the audit sample from the provider to prevent possible misrepresentation of the results 

of the audit or compliance test.

86. Comment: We are concerned there may be a fundamental flaw in the proposed plan 

that may have an impact on cost and/or program administration. Current PT providers that will 

be AASPs go to great lengths to ensure that true values are not known to the laboratory. PT
29

programs are typically administered to cover discreet periods of time with a single set of samples 

issued to a laboratory for analysis and reporting. The participating laboratories report the results 

back to the PT providers where performance is evaluated. If audit samples are to be submitted by

a facility with each compliance test or test event, it is highly likely that a laboratory will receive 

the same audit sample from the same AASP more than once, especially during periods when 

many permitted facilities are conducting HWC compliance testing test every 2.5 years while

others test annually. This could compromise the program’s integrity, especially if results are 

made available in a timely manner to the Permittee as the Permittee would want. If the AASPs 

must prepare and provide a different audit sample for every compliance test, this will certainly

drive the cost of the audit samples up. (0015)

Response: EPA agrees that the sample’s true value needs to remain blind to the sources 

and laboratories at least until the values are reported. The rule has been revised to state that only

pass/fail results will be reported unless the AASP ensures that no laboratory receives the same 

sample twice.

External QA program

87. Comment: In its restructuring of the SSAP, EPA proposes to replace the audit 

sample requirements in existing test methods with a requirement in the general provisions of 

Parts 60, 61, 63, and 51, Appendix M, that each “performance test” include an “external QA 

program” including, at a minimum, a test method “performance audit (PA)” during the 

performance test. Thus the Part 60 program would no longer be limited to specific test methods, 

but instead would apply to any “performance test” and would require something more than 

analysis of audit samples. EPA does not explain what other requirements might exist for the 

“external QA program,” other than the proposed requirement that it “may also” include “systems 

audits,” which the proposed rule describes using the same vague language in §63.7(c)(2)(iii). 

UARG objects to EPA’s proposal to remove the audit sample requirements from individual test 

methods and objects to the requirement to develop something called an “external QA program” 

for each performance test. (0024)

Response: The only mandatory requirement under the restructured audit program is to 

include an audit sample with each compliance test. EPA has revised the final rule to make this 

clear.

No justification for program

88. Comment: EPA did not provide a justification for continuing the current program or 

expanding the program. Three commenters believe that the emergence of private providers is an 

insufficient rational for the rulemaking. (0014, 0019, 0020, 0024, 0026)

Response: We disagree. The emergence of private providers is one reason for changing 

the audit program. We discussed other reasons for privatizing the audit program in the Notice of 

Proposed Rule Making. Also, we believe allowing private companies to provide audit samples 

will 1) insure a wider range of audit sample concentrations that will better match the working 

range of the methods, 2) provide a more efficient and responsive system for supplying the 
30

required samples, 3) insure greater transparency in the operation of the audit program, 4) produce 

higher quality audit samples, and 5) insure a more stable supply of samples.

89. Comment: EPA’s proposed privatization of the SSAP is designed to transfer the 

Agency’s obligations with respect to the SSAP to private parties who would then fund what 

previously were EPA regulatory activities (like establishing future audit sample requirements 

and criteria), UARG questions whether the restructuring might be an unlawful augmentation of 

EPA’s Congressional appropriation and a violation of the Miscellaneous Receipts statute, 31 

U.S.C. §3302(b). If EPA’s goal is simply to pass to sources the cost of purchasing audit 

samples, that goal can be achieved without a total privatization of the program. (0024)

Response: The reason for the restructuring is not budgetary. As we stated in the 

preamble, there previously were no private entities who supplied stationary source audit samples 

so EPA provided them. But now there are private sources for these types of samples. EPA is not 

under any statutory requirement to provide audit samples and therefore does not believe it is 

appropriate to do so when private providers are available. EPA does not believe the program, as 

structured, violates the Miscellaneous Receipts Act.

90. Comment: The proposal to restructure the stationary source audit process would 

significantly increase source owners’ and operators’ testing costs and time periods for data 

collection without a discernable improvement in data quality. (0019)

Response: See response to Comment 38 with respect to testing costs. EPA does not see 

how this rule changes the time periods for data collection from what it is today. In fact, the time 

it takes for a facility or laboratory to learn if it passed the audit may be shorter than the time to 

go through a compliance authority. 

Consistency

91. Comment: Although the proposed rule does not suggest that in-house source testing 

firms would be relieved from compliance with the requirements of a source audit program, the 

audit program should be administered consistently regardless of the affiliation or size of the 

testing firm and that in-house testing groups should not be exempted. (0011)

Response: EPA agrees that the program should be administered consistently. The 

proposed rule does not relieve any facility from the requirement of using audit samples during 

stationary source compliance testing regardless of the size or affiliation of the testing firm or 

laboratory.

92. Comment: As a national source testing firm, we must conform to or comply with a 

patchwork of programs, all of which have the stated purpose of "improving emission test data 

quality.” Accordingly, we encourage EPA to use this opportunity to advance data quality 

programs that are consistent for all source test programs and have applicability in all 

jurisdictions. (0011)
31

Response: EPA has different programs because they have their own separate needs and 

issues whether it be different media, different measurement levels or different data quality needs 

and therefore, it is not possible to make all the programs consistent in how they evaluate 

emission data.

93. Comment: On page 38, "Part 60 - Standards of Performance for New Stationary

Sources", Section 60.8(g)(1) states in part "...the owner, operator, or representative may report 

the results of the audit sample to the compliance authority and report the results of the audit 

sample to the AASP or the APTSP prior to collecting any emission samples." On page 30, 

"Appendix M to Part 51-Recommended Test Methods for State Implementation Plans", Section 

4a, and elsewhere repeated in the proposed rule (pages 65 and 79) state in part: "...the owner, 

operator, or representative may report the results of the audit sample to the compliance authority 

and then report the results of the audit sample to the AASP or the APTSP prior to collecting any

emission samples." (emphasis added). Note the statement in Part 51 has the additional word 

"then," which could be interpreted to mean that the results could be reported to the AASP or 

APTSP at some later time after reporting to the compliance authority, whereas the statement in 

Part 60 could be interpreted to mean that the results should be reported to the compliance 

authority and to the AASP or APTSP at the same time. The statement in Part 51 should be 

amended to remove the word "then" to correspond with the statement in Part 60. (0012)

Response: EPA agrees that the two statements should be consistent. The final rule has 

been revised so all parts require that the audit sample results be reported to the compliance 

authority and the audit sample provider at the same time.

94. Comment: EPA needs to revise the NESHAP General provisions for consistency

with the proposed audit restructuring program. Provisions in 63.7(4)(i) state that “audit materials 

may be obtained by contacting the appropriate EPA Regional Office or responsible enforcement 

authority.” This language conflicts with the proposed rule if audit samples are to be obtained 

from an Audit sample provider. (0027)

Response: EPA agrees and the final rule has been revised to correct the inconsistency.

Ordering audit samples

95. Comment: It is not clear who is responsible for obtaining the audit samples. The 

proposed rule allows the source or an agent for the source to request the audit sample for a 

source test. It is unclear to the requesters what exactly that means. What type of documentation 

would be needed by the agent to demonstrate to the AASP that it is indeed an agent for the 

source? (0008, 0011)

Response: This provision was intended to allow the source owner or someone designated 

by the owner such as a member of a source testing firm to request the audit sample. The agent 

would need to work with the AASP to provide any documentation necessary to satisfy the AASP 

that they were an agent acting for the source.
32

96. Comment: We believe there should be a time-frame for the source to order audits 

and the regulatory agency should be notified when an audit was ordered. (0017)

Response: The final rule has been revised to provide the compliance authority input into 

the audit concentration range which in itself provides the compliance authority notification of an 

audit order. We believe the time frame for ordering audit samples is between the source owner,

compliance authority and the AASP, not an issue to be covered by this rule.

EPA maintain list of Audit providers

97. Comment: If the affected source owners seek the lowest cost AASPs, then there 

could be audit sample shortages, unforeseeable variations in costs, audit quality issues, and. last 

minute failures in AASPs supplying audit samples. We encourage EPA to consider the 

substantial effort and expense that both the regulated source and the AETB must undertake in 

"preparation for a test, only to find at the last minute that the audit material offered by an AASP 

is unavailable as offered or advertised. Clearly, an AASP that fails to deliver audit material as 

offered or promised must be flagged or removed from the list that EPA proposes to post. (0011)

Response: We intend to monitor the progress of this new system of supplying audit 

samples to ensure that it works as anticipated. We trust that most AASPs will deliver on their 

contracts, as most businesses want repeat customers.

98. Comment: The rule needs to include a requirement on the part of EPA to maintain 

an online data base of the current AASP-certified providers. The data base serves to 

communicate which providers are current relative to certification status and the types of samples 

provided. The web site location of the database needs to be included in the text of the rule. 

(0015, 0023)

Response: EPA does not believe a regulatory requirement is necessary and EPA will 

keep the website updated and accurate.

EPA’s 2003 study on quality gas cylinder samples

99. Comment: Reliance on voluntary consensus requirements for accreditation of audit 

samples does little to improve the reliability of compliance testing, and may threaten the quality

of the testing itself without additional procedures for qualifying and auditing private entities. 

This makes the EPA proposal arbitrary and unreasonable. As proof of this contention, as part of 

a 2003 study, EPA performed an audit of 42 source-level, tri-blend, EPA Protocol calibration gas 

cylinders from a total of 14 major gas vendors nationwide. The cylinders contain blends of SO2, 

NO, and CO2 in a N2 balance. The gas concentrations are (1) 50 ppm SO2, 50 ppm NO, and 5% 

CO2; (2) 500 ppm SO2, 400 ppm NO, and 12% CO2; and (3) 1000 ppm SO2, 900 ppm NO, and 

18% CO2. The cylinders were purchased by a third party so that the gas vendors did not know 

that EPA was analyzing the cylinders. The purpose of the audit was to help vendors improve gas 

quality, and to help calibration gas buyers identify good gas vendors. The overall failure rate 

was 11% on a gas component basis, and 57% on a vendor basis. No additional evidence of the 
33

availability or the quality or calibration of private vendor audit samples has been offered to 

refute EPA’s own study. (0020)

Response: This study is not relevant to the proposed restructuring of the audit program. 

The gas vendors surveyed in this study were not accredited to produce EPA protocol calibration 

gases because the protocol gas program does not require accreditation and were not subject to 

any third party verification. The restructured audit program requires that providers be accredited 

and that recurring third party verification of the quality of the audit samples be produced.

Audit requirements in methods

100. Comment: Although UARG objects to the proposed expansion of the SSAP to 

include some other undefined QA program, and the disassociation of the audit sample 

requirement from individual test methods, UARG would not oppose a requirement in the general 

provisions to comply with audit sample requirements “where contained in an individual test 

method,” or to a general provision addressing other details of audit sample analysis requirements 

(such as where and when to send audit sample results), where applicable. Defining and 

codifying those aspects of the program that are consistent among all test methods would be an 

appropriate use of the general provisions. In short, EPA should revise its proposal to retain audit 

sample requirements and acceptance criteria in individual test methods involving manual 

analysis of samples, and to limit the proposed addition to the general preamble to those 

implementation details that currently are not defined or are not defined consistently. (0024)

Response: There is already a requirement in 40 CFR Part 63 to use audit samples for all 

test methods, so we think that this an appropriate amendment to the general provisions of Parts 

51, 60, and 61. We have specifically exempted those test methods for which audit samples are 

not appropriate.

EPA’s proposal is premature 

101. Comment: To our knowledge, there are no existing third party accrediting bodies 

for audit sample providers, and therefore there are no AASPs from which to obtain audit samples 

under this proposed rule. For this reason, EPA’s proposal is premature at best. EPA cannot 

propose a program that requires source compliance when none of the structure required for its 

implementation exists. It is not sufficient for EPA to simply propose a framework and then to 

develop the details of the program after the opportunity for notice and comment has passed. 

(0024)

Response: As stated previously, an audit sample is required with compliance testing only 

when a sample is available, except where exempted in the regulations. EPA is permitted to 

develop regulatory criteria for approval of criteria documents from audit sample providers and 

did this in the proposed rule which provided an opportunity for notice and comment. These are 

not “details of the program” to be determined at a later date. If an audit sample provider’s 

criteria document meets the regulatory criteria, it will be approved and the sample provider may

provide samples for sources conducting compliance tests.
34

Audit samples should be delivered to lab

102. Comment: A more efficient method is for a plant site to order the required audit 

samples and have the provider ship the samples directly to an off-site external lab. Since the 

program does not address the act of sample collection, there is little to no value in having the 

audit samples shipped to the plant site. In addition, transporting a blind audit sample in and out 

of a petrochemical facility may cause transportation complications. In many cases, 

transportation regulations require the identification of the chemicals present along with 

concentrations and hazards. Thus, the AASP would be required to identify the chemicals present 

and indicate in a general fashion the approximate concentration of the various chemicals that are 

present in the blind audit sample. (0015, 0023)

Response: The EPA audit program allowed analytical audit samples to be shipped 

directly to the laboratory if requested by the compliance authority. We do not see any problem 

with that option unless it is an audit sample that is intended to be collected out in the field. 

Those types of audit samples must be collected in the field and sent to the laboratory with the 

stack samples.

Audit samples on test site during testing 

103. Comment: The audits should be required to be at the test site during testing, then 

handled, stored, packaged and shipped with the stack samples, unless the Compliance authority

waives this requirement. (0010)

Response: See response to Comment 102

VCSB standard does not meet EPA’s needs

104. Comment: The entire proposal is short on detail. Presumably this will be addressed 

through EPA's approval of Accrediting Bodies, where EPA would specify additional details. 

Will it? A VCSB may be able to agree to standards, but what if those standards do not serve the 

needs of EPA or other Regulators? The Regulators most interested in the audit program may not 

have the time to be involved in every VCSB that decides to write standards. (0010)

Response: We believe that any program that meets the minimum criteria specified in the 

final rule will meet the needs of the EPA and other compliance agencies. The criteria in the final 

rule ensure that any program that is developed by the private sector and approved by EPA will be 

equivalent to EPA’s current audit program.

Gas audit samples entry point

105. Comment: Section 60.8(g) states: “For pollutants that exist in the gas phase at 

ambient temperature, the audit sample shall consist of an appropriate concentration of the 

pollutant in air or nitrogen that can be introduced into the sampling system of the test method at 

the same entry point as a sample from the emission source.” In source gas sampling work, 

calibration gases as well as audit gases are introduced in the probe such that they pass through 
35

most of the probe tube and all filters and other components of the sampling system. However, it 

is not always practical to introduce the calibration gas at the same entry point as the source gas. 

We recommend changing the above wording in Section 60.8(g) to the following: “For pollutants 

that exist in the gas phase at ambient temperature, the audit sample shall consist of an 

appropriate concentration of the pollutant in air or nitrogen that can be introduced into the 

sampling system of the test method at or near the same entry point as a sample from the emission 

source.” (0026)

Response: EPA agrees that it may not always be practical to introduce the calibration gas 

at the same entry point as the source gas. EPA has revised the final rule to allow introduction of 

the audit sample “at or near” the entry point for the sample from the emission source.

TNI’s finalized standards in the EPA final rule

106. Comment: In the June 16 proposed rule, the Agency referenced some existing 

consensus standards developed by TNI for the accreditation of PT providers and the analysis of 

PT samples. The recently formed TNI Stationary Source Audit Sample (SSAS) Expert 

Committee has developed three new TNI standards for EPA’s SSAP. These new standards 

address the overall roles and responsibilities of the entities that participate in the SSAP, the 

specific responsibilities of SSAS providers, and the specific responsibilities of provider 

accreditors. In accordance with the TNI Procedures Governing Standards Development, these 

standards are expected to be final on or around August 11, 2009, after the comment period for 

this proposed rule closes. TNI requests the Agency consider the new TNI standards as it moves 

forward with this regulation. (0009)

Response: EPA will determine whether the TNI standards meet EPA’s regulatory criteria 

when they are completed and submitted to EPA for approval after EPA’s rule is promulgated.