Document ID: EPA-HQ-OECA-2006-0931-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-05-11T04:00Z

Information Collection Request for

Performance Evaluation Studies of Water and Wastewater Laboratories 

April 2007

Prepared by:

U. S. Environmental Protection Agency

Office of Enforcement and Compliance Assurance

Office of Compliance

Agriculture Division

Laboratory Data Integrity Branch

1200 Pennsylvania Ave., NW

Washington, D.C.  20460TABLE OF CONTENTS

  TOC \h \z \t "H1,1,H2,2,TOC1,1"    HYPERLINK \l "_Toc162925261"  1
IDENTIFICATION OF THE INFORMATION COLLECTION	  PAGEREF _Toc162925261 \h 
1  

  HYPERLINK \l "_Toc162925262"  1(a)	Title and Number of the Information
Collection	  PAGEREF _Toc162925262 \h  1  

  HYPERLINK \l "_Toc162925263"  1(b)	Short Characterization	  PAGEREF
_Toc162925263 \h  1  

  HYPERLINK \l "_Toc162925264"  2	NEED FOR AND USE OF THE COLLECTION	 
PAGEREF _Toc162925264 \h  3  

  HYPERLINK \l "_Toc162925265"  2(a)	Need/Authority for the Collection	 
PAGEREF _Toc162925265 \h  3  

  HYPERLINK \l "_Toc162925266"  2(b)	Practical Utility/Users of the Data
  PAGEREF _Toc162925266 \h  3  

  HYPERLINK \l "_Toc162925267"  3	NONDUPLICATION, CONSULTATIONS, AND
OTHER COLLECTION CRITERIA	  PAGEREF _Toc162925267 \h  4  

  HYPERLINK \l "_Toc162925268"  3(a)	Non-duplication	  PAGEREF
_Toc162925268 \h  4  

  HYPERLINK \l "_Toc162925269"  3(b)	Public Notice Required Prior to ICR
Submission to OMB	  PAGEREF _Toc162925269 \h  4  

  HYPERLINK \l "_Toc162925270"  3(c)	Consultations	  PAGEREF
_Toc162925270 \h  4  

  HYPERLINK \l "_Toc162925271"  3(d)	Effects of Less Frequent Collection
  PAGEREF _Toc162925271 \h  5  

  HYPERLINK \l "_Toc162925272"  3(e)	General Guidelines	  PAGEREF
_Toc162925272 \h  5  

  HYPERLINK \l "_Toc162925273"  3(f)	Confidentiality	  PAGEREF
_Toc162925273 \h  6  

  HYPERLINK \l "_Toc162925274"  3(g)	Sensitive Questions	  PAGEREF
_Toc162925274 \h  6  

  HYPERLINK \l "_Toc162925275"  4	THE RESPONDENTS AND THE INFORMATION
REQUESTED	  PAGEREF _Toc162925275 \h  7  

  HYPERLINK \l "_Toc162925276"  4(a)	Respondents and NAICS/SIC Codes	 
PAGEREF _Toc162925276 \h  7  

  HYPERLINK \l "_Toc162925277"  4(b)	Information Needed	  PAGEREF
_Toc162925277 \h  7  

  HYPERLINK \l "_Toc162925278"  5	THE INFORMATION COLLECTED – AGENCY
ACTIVITIES, COLLECTION METHODOLOGY AND INFORMATION MANAGEMENT	  PAGEREF
_Toc162925278 \h  9  

  HYPERLINK \l "_Toc162925279"  5(a)	Agency Activities	  PAGEREF
_Toc162925279 \h  9  

  HYPERLINK \l "_Toc162925280"  5(b)	Collection Methodology and
Management	  PAGEREF _Toc162925280 \h  9  

  HYPERLINK \l "_Toc162925281"  5(c)	Small Entity Flexibility	  PAGEREF
_Toc162925281 \h  9  

  HYPERLINK \l "_Toc162925282"  5(d)	Collection Schedule	  PAGEREF
_Toc162925282 \h  9  

  HYPERLINK \l "_Toc162925283"  6	ESTIMATING THE BURDEN AND COST OF THE
COLLECTION	  PAGEREF _Toc162925283 \h  10  

  HYPERLINK \l "_Toc162925284"  6(a)	Estimating Respondent Burden	 
PAGEREF _Toc162925284 \h  10  

  HYPERLINK \l "_Toc162925285"  6(b)	Estimating Respondent Costs	 
PAGEREF _Toc162925285 \h  11  

  HYPERLINK \l "_Toc162925286"  6(c)	Estimating Agency Burden and Costs	
 PAGEREF _Toc162925286 \h  13  

  HYPERLINK \l "_Toc162925287"  6(d)	Estimating the Respondent Universe
and Total Burden and Costs	  PAGEREF _Toc162925287 \h  13  

  HYPERLINK \l "_Toc162925288"  6(e)	Bottom Line Burden Hours and Cost
Tables	  PAGEREF _Toc162925288 \h  14  

  HYPERLINK \l "_Toc162925289"  6(f)	Reasons for Change in Burden	 
PAGEREF _Toc162925289 \h  14  

  HYPERLINK \l "_Toc162925290"  6(g)	Burden Statement	  PAGEREF
_Toc162925290 \h  15  

  HYPERLINK \l "_Toc162925291"  APPENDIX A: LIST OF CHEMISTRY &
MICROBIOLOGY ANALYTES AND WET TEST METHODS	  PAGEREF _Toc162925291 \h 
16  

  HYPERLINK \l "_Toc162925292"  APPENDIX B: LIST OF TOP CHEMISTRY &
MICROBIOLOGY ANALYTES AND WET TEST METHODS AND TIMES FOR ANALYZING	 
PAGEREF _Toc162925292 \h  18  

 

1	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title and Number of the Information Collection  TC "1(a)	Title and
Number of the Information Collection" \f C \l "2"   

Performance Evaluation Studies of Water and Wastewater Laboratories. OMB
Control No. 2080-0021, ICR No. 0234.09.

1(b)	Short Characterization  TC "1(b)	Short Characterization" \f C \l
"2"  

This is a request for a new Information Collection Request (ICR) to
support the collection of Proficiency Testing (PT) data to test the
performance of laboratories that conduct discharge analyses. The
expiring ICR (Performance Evaluation Studies of Water and Wastewater
Laboratories (OMB Control No. 2080-0021, EPA ICR No. 0234.08)) included
water quality studies:  Discharge Monitoring Report – Quality
Assurance Study Program (DMRQA), Water Pollution (WP) and Water Supply
(WS) studies.   The WP study has been discontinued and the WS study is
being addressed in a separate ICR.  This ICR refers only to DMR-QA. 
Therefore, the figures for burdens only support DMR-QA.  EPA is
requesting a standard three-year clearance for this ICR.  

Chemical monitoring data for drinking water and wastewater are submitted
from a variety of laboratories to the United States Environmental
Protection Agency (EPA) every year.  These results must be relied on by
EPA, as they form the primary basis for its regulatory decisions.  In
order to provide an objective demonstration that these laboratories are
submitting reliable information, the subject Performance Evaluation (PE)
studies were developed.  Participation in the Discharge Monitoring
Report - Quality Assurance (DMR-QA) studies is mandatory for major
wastewater dischargers and select minor dischargers under the National
Pollutant Discharge Elimination System (NPDES) permit.  Major
dischargers are defined as facilities that discharge at least 1 million
gallons of waste water per day and also those facility(s) servicing at
least 10,000 homes.  Minor dischargers are selected to monitor select
analytes/toxics discharged by the facility.

EPA originally administered the preparation of test standards for all
three programs as part of the Agency’s mandate to assure the quality
of environmental monitoring data. Currently, preparation, distribution
and grading of the test standards for the previously mentioned programs
have been privatized to lessen EPA’s burden in carrying out this
mandate.  Private sector companies, known as Proficiency Testing (PT)
providers, manufacture and distribute test samples to the contract and
in-house laboratories.  The laboratories submit their analytical results
to the PT providers for evaluation.  The PT providers evaluate the
submitted data and send the graded results to the NPDES permit holder
(permittee), who will review the results and forward the data to their
designated certifying/enforcement authorities.  Providers also send
electronic copies of the graded results to the designated
certifying/enforcement authorities and to EPA.  These graded results
include the names and addresses of the laboratories, the analytes that
were tested, the concentration of the analyte, and the acceptance
criteria and evaluations. 

EPA is required to conduct this ICR analysis because more than nine
non-Federal entities will be asked to respond to these data requests. 
Because state agencies use the resulting data for their own laboratory
certification/enforcement programs, and are not reporting any
information from the PT studies to EPA, they do not incur any burden
under this ICR.  In addition, cost and burden to PT Providers are not
considered in this ICR because the vendor costs associated with this
program are accounted for in the pricing of their standards (i.e., the
costs incurred by the Providers is factored into the cost of the PT
standards).

The total annual burden and labor costs incurred by the 7516 permittees
associated with this ICR are estimated to be 47,351 hours and $2,494,260
per year over the 3-year ICR period (2007 – 2009), or 6.3 hours and
$332 per year per respondent.  Respondent labor costs are linked with
the time it takes to read and understand the annual DMR-QA announcement
sent by EPA, plan activities, analyze PT standards, report information
to the PT providers, and maintain records.  Respondent operation and
maintenance (O&M) costs are associated with purchasing the PT standards.
 No costs or burdens to PT Providers or state agencies are associated
with this ICR.



2	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection  TC "2(a)	Need/Authority for the
Collection" \f C \l "2"  

Laboratory Performance Evaluation (PE) studies are designed to fulfill
the need to monitor the quality of analytical data for select critical
analytes within major point-source discharge samples.  Results from the
PE studies over time have generally shown a slow but regular improvement
in average performance by the laboratories producing the monitored data.
 By helping laboratories identify and correct analytical problems, the
PE studies are also responsible for documented improvement in this data.

Public Law 92-500, the Federal Water Pollution Control Act Amendments of
1972, and the related regulations in 40 CFR part 136, required extensive
analysis of water and wastewater samples by EPA, state, local government
and private laboratories, to maintain ambient water quality and control
point-source discharges.  These monitoring requirements were continued
in the Clean Water Act of 1987 § 308(a) (Federal Water Pollution
Control Act, Public Law 100-4, 33 U.S.C. § 1318).  EPA bases many
important decisions upon this data.  The data quality depends heavily
upon the availability of capable laboratory analysis at all levels and
reliability must be ensured.

2(b)	Practical Utility/Users of the Data  TC "2(b)	Practical
Utility/Users of the Data" \f C \l "2"   

States and laboratory personnel will use the results of these studies to
identify problems associated with laboratory analysis and substandard
facility discharges.  This will improve the quality of water data in
critical monitoring areas and the quality of facility discharge returned
to the environment.  These studies have demonstrated that problems exist
and arise periodically with all dischargers and water testing
laboratories; without future studies, many such problems will go
unrecognized and unresolved.  Results from the DMR-QA studies are used
to highlight NPDES facilities and laboratories with apparent analytical
problems that should be inspected on-site by state regulatory personnel.
 Results from the PT studies are used by State personnel as a major part
of the basis for certifying laboratories to produce required regulatory
data and as a base for potential regulatory enforcement.  

3	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a)	Non-duplication  TC "3(a)	Non-duplication" \f C \l "2"   

The DMR-QA accepts data and results from any of the other federally
sponsored water quality programs, such as the WP program, generated
within the DMR-QA performance dates.  The DMR-QA study commences on June
2nd, or the next business day, and concludes on the last Friday of
August of each year.  Duplication of efforts is being eliminated.  

	

3(b)	Public Notice Required Prior to ICR Submission to OMB  TC "3(b)
Public Notice Required Prior to ICR Submission to OMB" \f C \l "2"  

In compliance with the Paperwork Reduction Act, a notice of this
Information Collection Request ICR was published in the Federal Register
on January 3, 2007 (72 FR 130), with a correction published on January
22, 2007 (72 FR 2684).  This correction was due to an incorrect title on
the first Federal Register notice, which read “National Pollution
Discharge Elimination System (NPDES).  Modification and Variance
Requests” when it should have been “Performance Evaluation Studies
on Water and Wastewater Laboratories”

3(c)	Consultations

The DMR-QA has been administered by the EPA for over 26 years.  The
Office of Research and Development initiated and administered the
program until the responsibility was assigned to Office of Enforcement
and Compliance Assurance (OECA).  OECA will consider any comments
received and make appropriate adjustments to the program.  All eight PT
providers are accredited by the American Association for Laboratory
Accreditation (A2LA).  

A2LA is a nonprofit, non-governmental, public service, membership
society.  The mission of A2LA is to provide comprehensive services in
laboratory accreditation and laboratory-related training. 

The list of PT providers is available at   HYPERLINK
"http://a2la.org/dirsearchnew/nelacptproviders.cfm" 
http://a2la.org/dirsearchnew/nelacptproviders.cfm .  

One anonymous public comment was received which stated that the burden
estimates for a wastewater facility and the cost of obtaining samples
was underestimated.  In order to get more information from the regulated
public, a few permittees who are active in the DMR-QA program were
queried.  EPA randomly selected 8 permittees to provide additional
information for consideration.  Sixteen permittees were randomly
selected to be the pool for the 8 chosen to respond to the ICR request
for more information on the regulated public's burden to participate in
the annual DMR-QA study.

Tabs of paper were made, each labeled with one of the states/territories
participating in the DMR-QA.

These tabs of paper, each with a separate state, were mixed up in a hat.
 Two people were arbitrarily requested to retrieve 8 tabs each from the
hat.  

The list of active respondents to DMR-QA Study 26 was then scrolled
through rapidly until one of the 16 selected states/territories was
showing.  One of the permit numbers showing on the screen was randomly
selected.  

The retrieved permit numbers were numbered 1-16 and were sent to a third
person.  One of the first 2 people picked 8 numbers between 1 and 16 to
determine which facilities would be asked to assess the time needed to
complete the DMR-QA studies.

EPA received 2 comments from the 8 that were contacted.  One respondent
agreed with our estimates for time and cost burdens.  The other
respondent agreed with the time burden estimates but suggested adding to
the capital costs, the costs of buying test kits and standards, which
typically cost about $248.    

One permittee wished to remain anonymous.  The other permittee who was
contacted and responded to our inquiry is:

Eric Dodson

Permits & Analysis Manager

Environmental Department, City of Logan, UT

Phone:  (435) 716-9797

EPA also contacted all eight PT Providers; four responded, all wish to
remain anonymous.  They were questioned concerning how many permittees
and in-house/contract laboratories utilized their standards.  The
information submitted was converted into a ratio of laboratories to
permittees.  The ratio is necessary to compute the average, since
multiple permittees may use the same contract laboratory while other
permittees use their own in-house laboratory.  EPA has no way of
differentiating in-house and contract laboratories, so the term
“laboratory” will be taken to mean both in-house and contract
laboratory for this ICR.    

Not all of the PT Providers responded to our inquiry about the ratio of
laboratories to permittees, so EPA cannot determine whether a respondent
(permittee) used more than one provider, or if they used more than one
laboratory to report the results.  From the information received from
the four PT Providers, EPA estimated an average of 1.58 laboratories
(both in-house and contract) did work for 1 permittee, or a ratio of
0.633 permittee per in-house/contract laboratory.  

Furthermore, in order to distinguish Whole Effluent Toxicity (WET)
testing from chemistry and microbiology, the providers were asked how
many in-house and contract laboratories do WET testing.  The average
came to 4.77% of all labs.  This means that even though WET tests
require more time to do, the impact will be low among the permittees
since the percentage of labs doing WET tests is very low.  

PT Providers were also asked to give their input on the estimate for
time burdens as well as the fees which labs need to pay for samples
provided by the PT Providers.  An average was obtained of $260 per lab. 
It must be kept in mind that this is the cost that in-house and contract
laboratories pay, and this is passed onto the permittee.  Therefore, if
a lab is contracted by several permittees, then EPA considers that the
$260 will be distributed evenly among the permittees.  However, if a
permittee employs an in-house laboratory, the permittee is burdened with
the entire cost of obtaining samples ($260) as well as the labor costs
of the laboratory.  Since the ratio of in-house and contract
laboratories is unknown, an average was obtained for all laboratories.  

3(d)	Effects of Less Frequent Collection  TC "3(d)	Effects of Less
Frequent Collection" \f C \l "2"  

The current frequency for the DMR-QA is judged to be the minimum needed
to assess the accuracy of data production required by discharge permits.
 Laboratories producing data in a specific program are expected to
demonstrate adequate analytical proficiency once each year for each
analyte they test routinely.  Several water quality PE studies are
offered each year.   This allows the permittee to use its test results
to satisfy requirement in more than one water quality program. 
Collecting water quality data less than once per year to measure the
accuracy of laboratory work would potentially delay corrective actions
required by the permittee and therefore compromise discharge water
quality.  

3(e)	General Guidelines

This ICR was prepared in accordance with the October 2001 version of the
ICR Handbook developed by EPA's Office of Environmental Information,
Office of Information Collection, Collection Strategies Division.  The
ICR Handbook provides the most current instructions for ICR preparation
to ensure compliance with the 1995 Paperwork Reduction Act (PRA)
Amendments and OMB's implementing guidelines. 

EPA believes participation in these studies is a reasonable requirement
for all laboratories routinely producing data for environmental water
regulation.  Any public health data on drinking waters, ambient waters
or effluents under regulation deserve the minimal quality assurance
check that these studies represent.

3(f)	Confidentiality  TC "3(f)	Confidentiality" \f C \l "2"  

This information collection does not require respondents to disclose
confidential information. 

3(g)	Sensitive Questions  TC "3(g)	Sensitive Questions" \f C \l "2"  

No questions of a sensitive nature are included in any of the
information collection requirements outlined in this ICR.

4	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents and NAICS/SIC Codes   TC "4(a)	Respondents and
NAICS/SIC Codes" \f C \l "2"  

Respondents in DMR-QA studies are NPDES permittees designated by the EPA
region or state with permitting responsibility and the laboratories
doing chemical/microbiological analysis and whole-effluent toxicity
testing for these major dischargers.  These respondents are most likely
from the following SIC Codes:

2011 - through 3999 - Manufacturers

4941 - Water supply systems

4952 - Sewerage systems

8734 - Water testing laboratories

4(b)	Information Needed

4(b)(i)   Data Items

In all laboratory PE studies, the data result from analyses of synthetic
samples that contain known amounts of specific compounds, usually
dissolved in reagent water.  In DMR-QA studies, the compounds are those
of primary interest with regard to the monitoring requirements in the
NPDES permits.  All studies also collect sufficient data to properly
identify and characterize the respondents.  Each respondent reports only
data for that portion of the study analytes for which they wish to be
certified or as directed by the responsible regulatory official.

4(b)(ii)  Respondent Activities  TC "4(b)(ii)	Respondent Activities" \f
C \l "3"  

The primary burden involves analyzing and reporting results for relevant
study samples according to instructions. Based on current historical
studies, 7,516 respondents participated in certification studies.    

The DMR-QA program requires 7,516 permittees to submit results annually.
 A percentage of these permittees do all the work onsite themselves,
using in-house laboratories. All the other permittees contract at least
some of the analysis to a commercial lab(s).  The commercial lab may do
work for many permittees; the DMR-QA results would then be sent to these
permittees.  Therefore, there are fewer labs than permittees.  However,
EPA does not have data on how many in-house labs and contract labs are
used.  Furthermore, EPA does not track how many laboratories
participated in one or more studies or how many permittees participated
in only chemistry and microbiology and those that also participated in
WET testing.  EPA is estimating the “maximum” impact of the DMR-QA
program on the regulated community.  EPA will assume that all 7,516
permittees will fulfill requirements for the top 10 chemistry &
microbiology analytes and the top 10 WET test methods.  This is a
conservative estimate on the high end because not all permittees do WET
testing.  

To provide an estimate of respondent burden, EPA assumes that a total of
4,757 in-house and contract laboratories will do work for the permittees
in the PT studies each year during the ICR period of 2007 – 2009. 
This number was reached by using a ratio of 1.58 in-house/contract
laboratories per permittee, based on data procured by 4 PT Providers who
were willing to share information (out of a total of 8 PT Providers). 
However, EPA cannot verify these numbers.  Some laboratories are assumed
to participate in one or both of these studies (chemistry & microbiology
and WET).  Based on information from the 4 PT Providers, EPA determined
that an average of 4.77% of all laboratories participate in WET
analyses, or 227 laboratories.  

EPA is not estimating the burden for the PT Providers, because this
burden is internalized in the cost of obtaining PE samples from the PT
Providers.  

Respondents (permittees) will participate in the following activities: 

Read Instructions: Each of the 7,516 respondents will read the
instructions provided by EPA.  

Plan Activities:  Each of the 7,516 respondents will incur burden to
plan activities associated with the PT studies.

Analyze Chemistry and Microbiology Analytes:  EPA assumes that all 7,516
respondents will participate in the PT studies for microbiology, trace
metals, demands, minerals, nutrients, and miscellaneous analytes as
required by respondents’ permits.  EPA assumes that 4,757 in-house and
contract laboratories will do the work for the 7,516 permittees.   

Analyze WET:  EPA assumes that all 7,516 permittees will participate in
the PT studies for WET.  It is assumed that 227 in-house and contract
laboratories will do the work for the 7,516 permittees.  

Report Results:  Each of the 7,516 respondents will incur burden to
report its study results to the PT provider.  

Maintain Records:  Each of the 7,516 respondents will incur burden to
maintain records associated with the PT study.

5	THE INFORMATION COLLECTED – AGENCY ACTIVITIES, COLLECTION
METHODOLOGY AND INFORMATION MANAGEMENT

5(a)	Agency Activities  TC "5(a)	Agency Activities" \f C \l "2"  

EPA has reduced its activity related to this information collection to
that of providing general guidance and oversight for the PT Providers
and the participating laboratories on an as needed basis.

5(b)	Collection Methodology and Management  TC "5(b)	Collection
Methodology and Management" \f C \l "2"  

EPA will notify the permittee of their requirement to participate in the
relevant PE program annually.  The permittee’s in-house or contract
laboratory will then select an accredited private PT Provider to provide
them with the appropriate samples.  The testing facility will then send
the analysis data of these samples to the PT Provider.  The permittee
will use the form approved by OMB to report DMR-QA results.  This form
will be available in two formats: a hard copy that will be part of the
announcement which is mailed annually and an online PDF form, available
on the EPA website.  This PDF form can be filled out and then printed
for submission.  The PT Provider will send evaluations of the submitted
data back to the permittee and the designated certifying/enforcement
authority. PT Providers will also send summary data in electronic form
to EPA for archiving.

	

5(c)	Small Entity Flexibility  TC "5(c)	Small Entity Flexibility" \f C
\l "2"   

The major requirement under Small Business Regulatory Enforcement
Fairness Act (SBREFA) is a regulatory flexibility analysis of all rules
that have a "significant economic impact on a substantial number of
small entities."  Since this data request is not part of a rule, this
ICR is not subject to SBREFA.  

5(d)	Collection Schedule  TC "5(d)	Collection Schedule" \f C \l "2"  

EPA determines the requirements for the frequency that a permittee must
demonstrate proficiency by passing a PE study. The study typically
starts on or around 2 June and ends on or around 31 August.  The
participating permittees’ in-house/contract laboratories demonstrate
their proficiency by passing a PE study conducted by an accredited PT
Provider for a fee. The PT Provider must submit the results of each
study to the state and EPA regional coordinator, as well as the EPA
National Coordinator.   

	

In summary: each participating in-house or contract laboratory must
report test results to the PT Provider once a year. The PT Provider must
electronically submit the results of all studies they conduct to
participating permittees and state and EPA regional coordinators.
Participating permittees must re-qualify for each analyte it reports one
year from the last certification that it received.

6	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

This section describes the estimated average annual burden and costs for
the information collection activities for PT studies that will be
conducted by laboratories.  For this data submission, PT providers and
state agencies and EPA have no burden and costs; this is discussed
further in Section 6(a).  The Agency's burden and cost estimates are
outlined in Section 6(c).

To estimate the costs, EPA made assumptions about the burden associated
with activities that would likely be needed to fulfill the request.  EPA
emphasizes that the per-respondent estimates represent the average
burden and cost over the 3-year period covered by this ICR (2007-2009). 
Some respondents may incur higher costs and some will fall below the
average.  A “worst-case” scenario is being used:  the assumption is
made that all respondents perform all the tests included in this
analysis.  As a result, the time burden may be a bit on the higher end. 

Burden and costs are not distinguished by categorized entities (state
and local government, and commercial permittees) because EPA currently
does not track this information.  EPA’s best estimate is that from the
total of 7,516 permittees, there are 3,591 state and local government
facilities and 3,925 commercial facilities

6(a)	Estimating Respondent Burden  TC "6(a)	Estimating Respondent
Burden" \f C \l "2"   

The average annual respondent burden (in labor hours) for permittees is
shown in Table 6.1.  PT Providers conduct the studies, removing this
burden from EPA.  Participating laboratories receive samples from the PT
Provider, return test results to the PT Providers and the PT Providers
evaluate the data and send reports to the laboratories, the state
accrediting authorities and EPA.  The total burden on the laboratories
is 47,351 hours, with an average of 6.3 hours per respondent (47,351
total hours divided by 7,516 permittees). This estimate includes burden
for participating laboratories to read instructions, plan activities,
analyze samples, submit data to the PT vendors, and maintain records.  

EPA assumes that the respondent burden will be divided among three labor
categories:  manager, chemist, and records clerk.  The labor associated
with each of the ICR activities are discussed in more detail below. 

Read Instructions:  EPA assumes that each of the 7,516 respondents will
require 0.5 hour to read the instructions provided by EPA.  The burden
will be evenly divided between a manager and chemist.

Plan Activities:  EPA assumes that the manager of each laboratory will
require 0.5 hours to plan activities associated with the PT studies. The
burden will be divided between a manager and chemist.

Analyze Chemistry and Microbiology Analytes:  A total of 7,516
permittees are expected to use a total of 4,756 laboratories (a ratio of
1.58 labs for every permittee).  Analysis is assumed to require
approximately 1.8 hours to analyze PT standards for the top 10 analytes.
 All hours will be incurred by a chemist.  See Appendix B for these
tests and the estimated time for an analysis.  

Analyze WET:  A biologist or project manager constructs the test
chambers and records organism mortality (morbidity) of test organisms
while a chemist analyzes the water chemistry.  Biologists and chemists
are assumed to require 2.4 hours to analyze PT standards for WET.  It is
assumed that 227 laboratories do this work for all 7,516 permittees.    

Report Results:  EPA assumes that each of the 7,516 respondents will
require 1.0 hours to report the results of the study to the PT Provider.
 The burden will be divided between a manager and records clerk. 

Maintain Records:  EPA assumes that a records clerk in each of the 7,516
laboratories will require 0.1 hours to maintain the files from the PT
study.

 

6(b)	Estimating Respondent Costs  TC "6(b)	Estimating Respondent Costs"
\f C \l "2"   

Table 6.2 shows the annual average costs for laboratories over the
3-year ICR period.  Average annual labor costs for all 7,516 permittees
are estimated to be $1,254,120.  Average annual O&M costs are estimated
to be $1,240,140.  EPA estimates each laboratory will incur an annual
average labor plus non-labor cost of $332 for this data collection
effort. (see Table 6.2).

6(b)(i)   Respondent Labor	

The labor cost was arrived at by estimating the amount of labor required
to participate on an annual basis in the DMR-QA study.  Labor costs are
based on information provided by the U.S. Department of Labor
Statistics, May 2005, National Industry Specific Occupational Employment
and Wage Estimate. The labor categories include a manager at an hourly
rate of $52.09, a data entry clerical person at an hourly rate of
$12.71, and a skilled technician or chemist to conduct the measurements
at an hourly rate of $23.65.  These values were adjusted for inflation
using the U.S. Department of Labor Bureau of Labor Statistics’s CPI
calculator (  HYPERLINK "http://data.bls.gov/cgi-bin/cpicalc.pl" 
http://data.bls.gov/cgi-bin/cpicalc.pl ).  Table 6.2 lists the estimated
burden and costs for labor related to each activity.  The annual
respondent labor cost, for all 7,516 respondents is estimated to be
$1,254,120 for 47,351 hours.  

	

6(b)(ii)   Respondent Operation and Maintenance Costs 

Operation and Maintenance (O&M) costs for laboratories include all costs
related to providing personnel with the space, equipment and materials
necessary to perform the tasks required by this ICR.  Since laboratories
are driven by their compliance monitoring requirements to purchase the
analytical instrumentation and computers and not by this ICR, no capital
costs can be considered associated to this ICR. Only the costs
associated with purchasing the PT standards is appropriate for
consideration in this category.   

Permittees may participate in the PT studies for some or all of the
chemistry, microbiology analytes and WET test methods (refer to Appendix
A for a list of chemistry and microbiology analytes and WET test
methods).  The cost of the PE samples varies with the costs for the
analytes, microbiological and WET testing required for each calendar
year. This is complicated by the fact that the participants in any given
study need not analyze all of the samples available for that study, only
the ones that are required by their permits. EPA determined a cost of
$260 per laboratory based on feedback from PT Providers who did an
analysis of the average cost of buying PE samples.  

Because EPA does not have sufficient information to estimate how many
analytes are contained in the PT samples sent to each laboratory, EPA
has estimated a "worst case" scenario by assuming that a single PT
sample contains standards for the top ten analytes for chemistry and
microbiology and the top 10 WET test methods, based on information from
the PT Providers.  Therefore, laboratories participating in the
chemistry and microbiology PT study are assumed to receive and run
analyses for 10 analytes.  Similarly, those participating in the PT
study for WET would receive samples for each of 10 WET test methods. 
EPA estimates the costs of obtaining PT samples to be $260 per
laboratory and $165 per permittee (respondent).  Average annual O&M
costs (fees for PE samples) for the respondents is estimated to be
$1,240,140.

 

6(b)(iii)   Capital/Startup Operating and Maintenance (O&M) Costs 

There are no Capital/Startup costs associated with this information
collection.  The annual Operating and Maintenance costs associated with
this ICR are estimated to be $165 per respondent. 

6(c)	Estimating Agency Burden and Costs  TC "6(c)	Estimating Agency
Burden and Costs" \f C \l "2"   

Since EPA’s role has been reduced to an advisory level only, there is
no longer any burden to the Agency, other than the time required to put
together the annual announcement and printing and mailing costs of the
annual announcement.  On average, 7,900 announcements are printed
annually, to send out to permittees, PT Providers, state and regional
coordinators as well as spare copies.  These annual burdens are
approximated below:

Maintaining records of active participants in the program:  520 hours (3
months)

Putting together the annual announcement and answering questions:  480
hours (40 hours/month)

Cost of printing 7,900 announcements:  $8736.00

Cost of mailing announcements:  $6,538.92

Total annual burden and cost to EPA:  1000 hours and $15,274.92

6(d)	Estimating the Respondent Universe and Total Burden and Costs  TC
"6(d)	Estimating the Respondent Universe and Total Burden and Costs" \f
C \l "2"   

The only respondents for this ICR are permittees.  They may use contract
laboratories to perform the work, but the burden is considered to be
upon the permittees, since they bear the costs of labor and operations &
maintenance.  As itemized in section 6(b), the annual respondent burden
is 6.3 hours and $332 per participant.  The total annual respondent
burden is 47,351 hours and $2,494,260 for 7,516 participants. Currently,
there are 8 PT Providers.  PT Providers’ burdens are not assessed in
this ICR because their cost burden for this ICR is part of the estimated
PE sample cost burden for the laboratories.  Burden and costs to EPA is
minimal, being limited to the drafting of the annual announcement and
printing/mailing costs, which come to a total of 1000 hours and
$15,274.92 on an annual basis.  

6(e)	Bottom Line Burden Hours and Cost Tables  TC "6(e)	Bottom Line
Burden Hours and Cost Tables" \f C \l "2"   

The bottom line burden hours and costs for this ICR are shown in Table
6.3.  This includes the burden and costs to the 7,516 laboratories that
are affected by this ICR.

 

6(f)	Reasons for Change in Burden	

There is an overall decrease of 10,679 respondents, of decrease of
132,984 hours, and a decrease $2,109,860 in the total costs currently
identified in the OMB Inventory of Approved ICRs.  

This change is primarily due to a program change that has produced a
decrease in estimates.  This renewal ICR does not include the burden
estimates for the WS and WP programs, only the DMR-QA program.  The WS
and WP programs are being covered elsewhere and/or are no longer part of
this ICR submission.  This resulted in a program change of -139,770
hours and -$2,382,913.

Some of this decrease was offset by adjustment increases due to
increased participation in the DMR-QA PE study.  Participation in the
DMR-QA PE study has increased from an estimated average of 6,489 to
7,516  since the last renewal of this ICR, while the list of average
analytes done by the average respondent was increased to include WET
test methods which were not included in the previous ICR.  This has
resulted in a increase adjustment of 1,027 respondents, 6,786 hours and
$273,053.

Labor and Operation & Maintenance costs were updated since the previous
renewal of this ICR.

The average cost of obtaining PE samples from the PT Providers was added
to this ICR to reflect the fact that respondents (permittees) have to
incur the burden of paying this cost passed on from the PT Providers. 

	

6(g)	Burden Statement	

The average annual respondent burden for each permittee is estimated to
be 6.3 hours per response.  This estimate includes the total time,
effort, or financial resources expended by permittees to gather and
report information, and develop and maintain record.  

Burden Statement:  The reporting burden for data collections included in
this ICR is detailed above.  The total annual respondent burden (for
years 2007 - 2009) imposed by these collections is estimated to be
47,351 hours, or 6.3 hours per respondent per year.  Estimates include
time for reading instructions, planning activities, analyzing standards,
reporting results, and maintaining records.

Burden means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide
information to or for a Federal agency.  This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.  An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.  The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9 and 48 CFR Chapter 15.   

To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID No.
EPA-HQ-OECA-2006-0931, which is available for   SEQ CHAPTER \h \r 1
online viewing at   HYPERLINK "http://www.regulations.gov" 
www.regulations.gov ,   SEQ CHAPTER \h \r 1 or in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Ave., NW, Washington, DC.  The EPA/DC
Public Reading Room   SEQ CHAPTER \h \r 1 is open from 8 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is 202-566-1744, and the telephone number
for the Enforcement and Compliance Docket is 202-566-0226.  

Use EPA’s electronic docket and comment system at   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov , to submit or view
public comments, access the index listing of the contents of the docket,
and to access those documents in the docket that are available
electronically.  Once in the system, select “docket search,” then
key in the docket ID number identified above.   Please note that EPA’s
policy is that public comments, whether submitted electronically or in
paper, will be made available for public viewing at   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov   as EPA receives them
and without change, unless the comment contains copyrighted material,
CBI, or other information whose public disclosure is restricted by
statute.    SEQ CHAPTER \h \r 1 For further information about the
electronic docket, go to   HYPERLINK "http://www.regulations.gov" 
www.regulations.gov .  Also, you can send comments by mail to the Office
of Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for
EPA.  Please include the EPA Docket ID No. EPA-HQ-OECA-2006-0931 and OMB
control number 2080-0021 in any correspondence. 

APPENDIX   SEQ APPENDIX \* ALPHABETIC  A : LIST OF CHEMISTRY &
MICROBIOLOGY ANALYTES AND WET TEST METHODS

 

 APPENDIX B: LIST OF TOP CHEMISTRY & MICROBIOLOGY ANALYTES AND WET TEST
METHODS AND TIMES FOR ANALYZING

 

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