Document ID: EPA-HQ-ORD-2009-0114-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-09-17T04:00Z

SUPPORTING STATEMENT

QUESTIONNAIRE FOR DRINKING WATER UTILITIES PARTICIPATING IN EMERGING
CONTAMINANT SAMPLING PROGRAM

INFORMATION COLLECTION REQUEST SUPPORTING 

U.S. ENVIRONMENTAL PROTECTION AGENCY

SEPTEMBER 2009

PART A OF THE SUPPORTING STATEMENT

1. 	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a) 	Title of the Information Collection

Questionnaire for Drinking Water Utilities Participating In Emerging
Contaminant Sampling Program (New)

1(b) 	Short Characterization/ Abstract

	This Information Collection Request (ICR) package requests the Office
of Management and Budget (OMB) to review and approve the U.S.
Environmental Protection Agency’s (EPA’s) Office of Research and
Development survey titled “Questionnaire For Drinking Water Utilities
Participating In Emerging Contaminant Sampling Program”.  

	Improvements in analytical chemistry instrumentation have allowed
scientists to detect trace amounts of chemicals that are commonly used
in homes in the environment.   These so-called “emerging
contaminants” are chemicals, such as pharmaceuticals, personal care
products, detergents and even endogenous hormones, which are either
excreted from or washed off the body, and enter the wastewater treatment
system.  Wastewater treatment is not designed to specifically remove
these chemicals, so a portion of the chemicals remain in wastewater
treatment plant (WWTP) effluents.  WWTP effluents are commonly released
into surface waters.  Natural processes such as photolysis, sorption,
volatilization, degradation, and simple dilution further attenuate the
concentrations of emerging contaminants.   However, if a Drinking Water
Treatment Plant (DWTP) intake is located downstream of a WWTP effluent
outfall, there is a potential for these chemicals to be present in
finished drinking water.    

	The EPA’s Office of Research and Development, in collaboration with
the U.S. Geological Survey (USGS), is conducting a sampling program at
up to 50 DWTPs to determine the presence of these emerging contaminants
in both the source water and finished drinking water.  To better
interpret the results of the sampling program, detailed information
concerning the operation of the DWTP at the time of sampling is
required.  This information can only be gathered through a questionnaire
that is completed concurrent to the collection event.  The questionnaire
will collect information on the following:

The population served by the DWTP;

The source water, potential sources of pollution and current hydraulic
conditions;

Detailed treatment steps used by the DWTP, including parameters such as
pumpage at sampling, disinfectants used, and distribution system
information;

Detailed water quality parameters at the time of sampling.

	The DWTPs involved in this project will ship samples of their source
water and finished water to the EPA and USGS laboratories.  All sampling
supplies and paid shipping vouchers will be provided to the DWTPs.  The
samples will be analyzed by the EPA and USGS for a suite of
approximately 200 emerging chemical and microbial contaminants.  A
detailed listing of the analytes, as well as the methods to be used can
be found in public docket for this ICR under Docket ID No.
EPA-HQ-ORD-2009-0114, which is available for   SEQ CHAPTER \h \r 1
online viewing at www.regulations.gov,   SEQ CHAPTER \h \r 1 or in
person viewing at the Research and Development Docket in the EPA Docket
Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW,
Washington, DC. 

	This project is not designed to provide a statistical representation of
the source and finished waters in the United States.   The sampling is
intentionally skewed to DWTPs that have known or strongly suspected
sources of wastewater in their drinking water source water, in an
attempt to determine the upper bounds of chemical detection frequency
and concentration.  This data can then be considered when designing
future sampling events which are designed to be statistically
representative of the DWTP population.

	The EPA will distribute the questionnaire to the DWTPs at the time of
sampling along with the sampling supplies.  The EPA estimates the total
respondent burdens and costs associated with completing the
questionnaire are approximately 1000 hours and $29,485.  The cost
estimate includes operational costs of photocopying and mailing the
completed questionnaire to the EPA ($250) if the DWTP chooses not to
submit the form electronically.  There are no capital costs associated
with the survey.  Additional details on burden can be found in Section
6.  An overview of the burden is provided below:

Estimated number of potential respondents: 50

Frequency of response: One-time

Estimated total number of responses for each respondent: One

Estimated total annual burden hours: 1000

Average burden hours per respondent: 20 

Average cost per respondent: $589.70 ($29,485)

2. 	NEED FOR AND USE OF THE INFORMATION COLLECTION

2(a) 	Need/Authority for the Information Collection

	

	The Safe Drinking Water Act, as amended in 1996, authorizes the EPA to
establish health-based standards limiting the concentration of natural
and man-made contaminants in drinking water.  The questionnaire that is
being reviewed in this package supports a screening sampling project
which will analyze drinking water samples collected across the United
States for a suite of approximately 200 emerging contaminants.  The
results of this study will help the EPA’s Office of Research and
Development advise the EPA’s Office of Water determine which chemicals
(if any) should be considered for future regulation in drinking water.  

2(b) 	Practical Utility/Users of the Data

	The EPA plans to use a survey questionnaire to solicit detailed
information from DWTPs participating in an emerging contaminants
sampling project.  The EPA will use this information to help interpret
the data collected during the water sampling program.  

3. 	NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION EFFORTS

3(a) 	Non duplication

	The National Exposure Research Laboratory of the EPA’s Office of
Research and Development has made every reasonable attempt to ensure
that the questionnaire does not request information available through
less burdensome mechanisms.  Many DWTPs maintain information on the
treatment technologies in use in their utility on a website or in their
annual consumer confidence reports (CCRs).  However, there is no
consistency between utilities on the detail of information available
through these mechanisms.  In addition, concerns over homeland security
have caused some information (such as drinking water intake locations
and their proximity to wastewater effluent outfalls) to be publically
unavailable.  The information gathered in the questionnaire will provide
consistent information across all DWTPs studied in this project.  There
is some overlap between questions asked during the pre-questionnaire
telephone survey and on the questionnaire itself.  The telephone survey
will be used to solicit participation in the study, as well as gather
cursory information about each DWTP.  The burden of the minimal
repetition between the telephone survey and the questionnaire is
outweighed by the value of having all pertinent information captured in
the single questionnaire response.  

3(b) 	Public Notice Required Prior to ICR Submission to OMB

Publication of the Federal Register Notice

	The EPA published a Federal Register notice (74 FR 15966) announcing
the Agency’s intent to submit a request for a new Information
Collection Rule (ICR) to conduct a survey of drinking water utilities
participating in a research project.  In addition to the announcement,
the Federal Register notice solicited comments to the draft
questionnaire that will be given to participants.  A copy of the notice
is included in Attachment A.

Public Response to Federal Register Notice

	The EPA received three comments on the initial Federal Register notice
(FRN; 74 FR 15966).  The FRN solicited comments as to the paperwork
burden imposed on drinking water utilities participating in a future
EPA/USGS sampling project as required by the Paperwork Reduction Act
(PRA; 44 U.S.C. 3501 et seq.); all the of comments received included
detailed remarks outside the scope and intent of the specific request
addressing specifics details of the sampling project itself.  While
these comments are not germane to the PRA burden, we appreciate the
constructive components of these remarks and address them in this
response.   All of the letters presented similar concerns, so the
comments have been aggregated in this response.  The comments are
separated by commenter, and are visually set off from the responses by
italics.

Collective Comment 1:  Scope, Format, and Use of Questionnaire 

Commenter A.   AMWA is also concerned about the use of the study
questionnaire responses together with paired source and finished water
samples “to help interpret the data collected during the water
sampling program.” The proposed questionnaire appears to be aimed at
collecting information that could be used to draw conclusions about
treatability as opposed to occurrence. AMWA believes that such
conclusions would be inappropriate given the limited number of samples
to be collected and the fact that only one paired sample (essentially
two grab samples) will be collected.

	Commenter B.  Similarly, the information collection request encompasses
data items like: population served, detailed description of the
treatment provided, blending practices, and the number and types of
upstream outfalls. The docket does not provide a rationale for why these
data are being collected, nor does it suggest how this information might
be of value to any existing or proposed regulatory program at EPA.

Commenter C.  The Potomac Partnership’s Metro Utility Committee
believes that the survey questionnaire is inadequate for interpreting
the results of the sampling program for a number of reasons.  Part B of
the questionnaire asks for information on wastewater and industrial
discharges within 25 miles upstream of an intake which seems to be an
arbitrary distance.  A better approach would be to define the area of
interest for this information (watershed, time-of-travel, source water
assessment area, etc.) or explain why a certain distance is significant.
 

The ICR announcement and questionnaire seem to emphasize wastewater
treatment plants as the primary source of emerging contaminants although
there are others sources of these compounds such as agribusinesses. 
While there is a general question in Part B of the questionnaire about
whether source water is impacted by agrichemicals, EPA should also
consult GIS coverages of land use/cover (crops, golf courses, utility
right-of-ways, etc.) and animal feeding operations to help assess these
impacts.  Part B also asks for data on previous emerging contaminant
analyses.  This should be clarified to ask about unpublished or internal
data so that utilities do not have to spend time reporting data that is
available in published studies or databases from government agencies.  

The questionnaire should not just be submitted electronically, but
should be provided as an editable document (a pdf where you can type in
responses) to make it easier to complete and return.

Response to Collective Comment 1

	

	As federal employees, the investigators involved in this project must
follow the PRA when collecting information from more than nine
respondents.  Gaining Information Collection Rule (ICR) clearance is a
long process (estimated to take nine months).  The questionnaire was
designed to capture all information we considered necessary to later
interpret the analytical data, in order to avoid having to go through a
second ICR clearance process to ask subsequent follow-up questions. 
Engineers within the EPA were consulted to ensure we asked relevant
questions about the treatment processes used in the drinking water
treatment plants (DWTPs).  Questions concerning population,
disinfectant, etc are included in the questionnaire document the
diversity of populations and processes within the DWTPs involved in the
study.  The majority of the emerging contaminants in this study (see
Comment / Response 4, below) are primarily introduced into the
environment through household wastewater, be it through a municipal
WWTP, or on-site wastewater treatment. To better qualitatively evaluate
the impact of drinking water treatment on pharmaceuticals and other
contaminants in wastewater effluents, the study will be intentionally
skewed towards facilities whose sources are known to be impacted by
upstream discharges of human waste, thereby increasing the potential for
detection in the source water.  Thus, documenting local knowledge of
waste sources potentially impacting each DWTP is important.  

In preparing a list of candidate sites, the investigators on this
project are working with their regional colleagues in the USGS and EPA
to assess background information such as livestock production and land
use, as well as obtain information on recent and on-going sampling
studies being conducted at the DWTPs.  

In many cases, the data that is reported by utilities to the EPA is held
as confidential business information by the unit it is reported to, and
is not available to the investigators in this project in a timely
manner.  We do not ask for the data to be formatted in any particular
way, just to recapitulate what they have already prepared.  We would not
expect this to be a difficult item, in terms of time or burden, to
fulfill.  

The questionnaire posted in the docket was generated using the default
Federal Docket Management System pdf generator.  The participating
utilities will be given a pdf they will be able to fill out
electronically, as well as a paper copy on which they can hand write the
information.  We prefer the electronic submission, but will accept
either.

Collective Comment 2:  Freedom of Information Act 

Commenter A.   Drinking water utilities are very concerned that the
limited information developed as a result of this information collection
could be obtained via a Freedom of Information Act (FoIA) request and be
misinterpreted. The data reported out of context could be very difficult
for the utilities to explain to the media and the public.

Commenter C. The Supporting Statement for the questionnaire includes a
provision for confidentiality of the utility.  However, this is not
explicitly included in the Federal Register Notice.  This should be
included in the final notice to allay concerns over public relations
issues based on the result of a single sample.

Response to Collective Comment 2

As this project is a federal work product, it is subject to Freedom of
Information Act (FOIA) requests from the public.  We plan to inform the
DWTPs at the outset that while we intend to preserve their anonymity to
the best of our ability, a FOIA is a possibility.  Prior to publication
of the data in a peer reviewed journal and/or EPA/USGS data reports, we
will give all DWTPs a copy of their analytical data, and provide them
the opportunity to comment on the manuscript(s) that will be generated. 
As with all studies, once the data is published we cannot control how
the data is used or misused by others.  We are doing all we can to
ensure that our publication(s) fairly and accurately summarize the data.
 

Collective Comment 3: Utility Burden Cost Estimates

Commenter A.   Finally, the cost estimates reflect industry wide
averages, which can be influenced by system size. Cost estimates should
be modified to reflect costs in those size utilities likely to
participate. Given that larger utilities will probably be most likely to
volunteer for a study like this one, the basis for this effort’s cost
estimates should be based on larger utilities.

Response to Collective Comment 3

We are unsure if this comment is implying the cost estimates are too
high or too low.  We were only able to find one source of salary data,
which was the median annual salaries reported by the American Water
Works Association (  HYPERLINK
"http://www.awwa.org/careercenter/resources/docs/JobDescriptions.cfm" 
http://www.awwa.org/careercenter/resources/docs/JobDescriptions.cfm ). 
In a previous study of nine DWTPs, we were able to partner with
utilities ranging in size from those producing less than 1 million
gallons per day (MGD) to more than 90 MGD, serving populations ranging
from 12,000 to 1.2 million.  For this study, we hope to obtain a similar
range of production size and sophistication, so we think the median
salaries are applicable. 

The cost estimates have been adjusted to include initial phone
interviews that will be used to finalize the candidate list.  The times
allotted for each activity have also been increased to hopefully
over-estimate the burden on the DWTP respondents.	

Collective Comment 4: Specific Analytes and Methods Used During Project

Commenter A.   There is no list of “emerging contaminants” to be
sampled or laboratory methods to be used.

Collecting occurrence information without standard sampling and
analytical methods is risky at best. If the analytical methods used for
this effort do not ultimately qualify as an agency approved method, will
the data be of use to the agency for future policymaking?

Although USGS and EPA staff indicated that the study design includes
rigorous quality assurance and quality control, this information is not
provided in the docket.

Commenter B.   As drafted, the information collection activity targets
“emerging contaminants.” The docket for this information collection
request does not include a description of the sampling or analytical
method(s) or target analytes that the effort would obtain. Absent a
clear understanding of what analytes are being measured, it is difficult
to determine if occurrence data are relevant to EPA’s activity under
the SDWA, Clean Water Act (CWA), or other regulatory programs. 

Response to Collective Comment 4

We are currently planning on using a suite of chemical and
microbiological methods to analyze the water samples collected in this
project for over 200 analytes, including:

117 prescription and nonprescription pharmaceuticals and their
metabolites

17 perfluorinated compounds

13 industrial chemicals

11 fragrances

9 polycyclic aromatic hydrocarbons

8 hormones 

8 pesticides

7 detergent related chemicals

7 household chemicals

4 plant and animal sterols

3 phosphorous based flame retardants

1 nanomaterial

5 bacteria 

3 fungi

2 protozoa

2 viruses

Included as Attachment B in the public docket for this ICR (No.
EPA-HQ-ORD-2009-0114) is a bibliography of the published analytical
methods that will be used on this project, as well as a listing of the
analytes that are contained in those methods.  Several methods are still
in the development process; the analytes listed in those methods are not
specifically included in the listing as some chemicals may be found to
be unsuitable, and will subsequently never be reported.

For this project, we have incorporated a very high level of quality
control and quality assurance samples to ensure we will be collecting
accurate and defensible analytical data.  For the chemical methods, all
samples will be collected in triplicate; one sample will be analyzed as
the primary sample, the second as a duplicate, and the third will be
spiked with the analytes to evaluate matrix interferences.  In addition,
a sample of certified laboratory water from the same lot will be shipped
to each location as a field blank.  The utilities will be instructed to
decant the laboratory water into sample bottles, to mimic any
contamination that may come from the personnel during sampling.  To aid
in comparability, all methods will use the same method of evaluating
their lowest level of detection- either the EPA method detection limit
(MDL; U.S. Environmental Protection Agency, 2005, Guidelines
establishing test procedures for the analysis of pollutants (App. B,
Part 136, Definition and procedures for the determination of the method
detection limit): U.S. Code of Federal Regulations, Title 40, revised as
of July 1, 2005, p. 319–322.), or the newer EPA Lowest Concentration
Minimum Reporting Level (LCMRL).  The MDL estimates a detection limit
based upon a method’s precision, while the LCMRL estimates a detection
limit based upon the precision and accuracy of a method, but requires
four times as many samples to calculate.  In all, considering the
duplicate sample, matrix spike, field blank, laboratory blanks and
spikes ran with every batch of samples, and the MDL or LCMRL samples,
well over 70% of the samples analyzed as part of this project will be
used for quality control purposes.

Fifty of the over 200 chemicals that will be measured in this project
are analytes in two (35 compounds), three (13), or four (2) analytical
methods.  The overlap between methods will provide another check on the
performance of the methods, and will give greater certainty to the
resulting concentration data. 

Methods used for drinking water regulatory purposes meet a stricter
requirement for ruggedness than methods typically published in the
literature.  The regulatory method development process typically
evaluates different extraction materials and analytical columns from
multiple vendors, focuses on wide ranges of pH and carbon content,
evaluates different de-chlorination agents and biocides, and conducts
extended (28 day) holding time studies.  Once the method is developed,
it is evaluated by two to four other laboratories to ensure the written
procedure is clear, and the method able to be successfully performed by
other analysts.  Any analyte that will be under consideration for
regulation must go through this development process, regardless of the
number of existing methods currently present in the literature. 
However, the methods used in this project could potentially be used as
starting point for the drinking water regulatory method development
process.

Collective Comment 5: Utility of the Data to the EPA 

Commenter A.   In speaking with USGS and EPA staff overseeing the study,
it is AMWA’s understanding that the results of the study will be used
to inform EPA’s Office of Water in selection of contaminants for the
Unregulated Contaminant Monitoring Rule (UCMR) or Contaminant Candidate
List (CCL). The information collection activity’s supporting statement
says that the results of the study will help EPA “determine which
chemicals should be considered for future regulation in drinking
water.” However, there is nothing in the docket about the study design
or rationale or how the study might be used to inform policy. 

AMWA supports the UCMR and CCL processes. There are many required
elements for a contaminant to make the UCRM list and/or the CCL. The
criteria that a contaminant must meet to make the list are extensive.
AMWA recommends that additional work be performed to develop this study
so that it better fits within the construct of existing regulatory
programs under the Safe Drinking Water Act, as well as programs under
the Clean Water Act. As currently constructed, AMWA believes that the
proposed data collection would mislead EPA’s effort for identifying
and prioritizing contaminants that should be further evaluated. The
following comments provide additional concerns about the proposed study
and suggestions for its improvement.

In summary, AMWA believes that the study as described in the Federal
Register notice is inadequately defined in the docket. As a result, the
study could mislead EPA’s effort for identifying and prioritizing
chemicals to be further evaluated. AMWA recommends that EPA provide
additional information in the docket describing the study hypothesis,
design, sampling and analytical methods, and purpose. AMWA also believes
that the study is potentially misdirected toward characterizing diluted
drinking water supplies instead of characterizing more concentrated
contaminant sources. This should be reconsidered and a rationale
described in the revised notice and docket. In addition, AMWA recommends
that this study build upon currently published data or studies currently
underway by others. In light of these concerns, AMWA suggests that this
study is insufficient to provide information of practical utility or
necessity for the “proper performance of the functions of the
Agency.” Once these issues have been addressed, another request for
comment should be issued before proceeding with the study.

Commenter B.   AWWA’s primary concerns are with respect to the first
three of these questions. The information provided in the docket
indicate that roughly 50 water systems will be provided a questionnaire
and that those same utilities will provide water samples for the
analysis of an unknown list of contaminants. EPA’s Safe Drinking Water
Information System (SDWIS) indicates that there are more than 51,970
community water systems (CWS) and an additional 102,865 non-community
water systems (NCWSs). More than 11,670 CWSs rely on surface water
supplies. Given the large number of water systems, it is not clear that
a sample design based on 50 locations would “have practical
utility.” It is worthwhile to note that EPA has a much more robust
sampling mechanism under the Safe Drinking Water Act (SDWA) known as the
Unregulated Contaminants Monitoring Rule (UCMR). EPA has successfully
used the UCMR mechanism to collect data from all systems serving greater
than 10,000 people and from a statistically valid sample of smaller CWSs
to guide federal drinking water policy development.

	

Response to Collective Comment 5

The commenter is correct that there are criteria the Agency has
established to consider contaminants that may require regulation as it
implements the Contaminant Candidate List (CCL) or Unregulated
Contaminant Monitoring Rule (UCMR).  The EPA’s Office of Water
(EPA-OW) evaluates and identifies which chemicals should be considered
for regulation in drinking water in the United States. The results
produced in this study will be one part of a comprehensive evaluation of
chemical occurrence data collected to help EPA “determine which
chemicals should be considered for future regulation in drinking
water.”

The EPA is required to publish, every five years, a list of contaminants
(1) that are currently unregulated, (2) that are known or anticipated to
occur in public water systems, and (3) which may require regulation
under the Safe Drinking Water Act (SDWA). That list is the CCL.    

EPA evaluates both health effects and occurrence information to identify
a broad universe of contaminants and select contaminants for inclusion
on the CCL.  The Agency considers chemicals whose properties, occurrence
in water supplies, and environmental chemistry indicate that they meet
the three criteria discussed above.   The Agency interprets the
criterion that contaminants are known or anticipated to occur in public
water systems broadly.  In evaluating this criterion, EPA considers not
only public water system monitoring data from the UCMR, but also data on
ambient concentrations in surface and ground waters, and releases to the
environment (e.g., Toxics Release Inventory).  The Agency anticipates
that results from this survey will provide additional valuable
information to consider for future CCLs.  While such data may not
establish that contaminants are known to occur in public water systems
at a national level, EPA believes these data will be sufficient to
anticipate that contaminants may occur in public water systems.  The
Agency will use these and other data to evaluate and consider potential
candidate contaminants for inclusion on the CCL.  Once contaminants have
been placed on the CCL, EPA identifies if there are any additional data
needs, including occurrence data, to determine if a regulation should be
developed.

The commenters are correct that EPA-OW can monitor for unregulated
contaminants under the UCMR.   The UCMR is unparalleled in terms of
gathering a statistically representative sampling of drinking water in
the United States; however, it is limited to a 30 contaminant maximum.
Under the UCMR, EPA may require monitoring of up to 30 potential
drinking water contaminants, during each 5 year UCMR cycle.  The UCMR
program is currently designed to assign contaminants to one of three
different levels of monitoring, based upon the cost of performing the
analysis, the availability of analytical methods, and the capacity of
the commercial laboratory system to perform these analyses. All public
water systems (PWSs) serving more than 10,000 people and 800
representative PWSs serving 10,000 or fewer people are required to
conduct the first level of monitoring, known as “Assessment
Monitoring.”  All large PWSs serving more than 100,000 people, 320
large representative PWSs serving 10,001 to 100,000 people, and 480
small representative PWSs serving 10,000 or fewer people are required to
conduct the second level of monitoring known as the “Screening
Survey”.  The third level of monitoring is reserved for those
contaminants which require monitoring using very expensive or very
limited use analytical technologies.   To fully evaluate the 200
chemical and microbial contaminants included in this project through
UCMR monitoring would be highly impractical; given the 30-contaminant
maximum and the 5-year UCMR cycle, it would take seven UCMR cycles over
the course of 35 years.   The Agency anticipates that the results of
this study will provide additional information on analytic methods and
the occurrence of PPCP chemicals in drinking water to help identify
contaminants for consideration under future UCMRs .  

We concur that this project will not have the statistical strength to
singly quantify removal percentages by the different treatment
techniques used at the DWTPs.  However, the results of this study will
provide qualitative information for EPA and the research community at
large to design more comprehensive studies to demonstrate whether
advanced treatment increases the removal efficacy for these compounds,
as compared to conventional treatment.

Since the publication of a series of articles by the Associated Press
discussing the presence of pharmaceuticals in the environment and in
drinking water, the American public, as well as Congress, have become
more aware of the topic and have raised questions about the presence and
human health impact of these compound in drinking water.  There are
currently two bills which have passed in the House of Representatives
and have been referred to Senate committees for deliberation.  The
National Water Research and Development Initiative Act of 2009 directs
federal agencies to collaborate on water quality issues including:

H.R. 1115, § 2(d)(19): Improvement of understanding of the impacts from
chemical impairments, including contaminants of emerging concern, such
as endocrine disrupting compounds, pharmaceuticals, and personal care
products, on water supply and quality.

The second bill, the Water Quality Investment Act of 2009, is directed
toward amending the Federal Water Pollution Control Act (33 U.S.C. 1251
et seq.), includes the following mandates for the EPA:

H.R. 1262, Title VI § 6001: Presence of Pharmaceuticals and Personal
Care Products in Waters of the United States.

Section 104 [of the Federal Water Pollution Control Act] (33 U.S.C.
1254) is amended by adding at the end the following:

‘(w) Presence of Pharmaceuticals and Personal Care Products in Waters
of the United States-

‘(1) Study- The Administrator, in consultation with appropriate
Federal agencies (including the National Institute of Environmental
Health Sciences), shall conduct a study on the presence of
pharmaceuticals and personal care products (in this subsection referred
to as ‘PPCPs’) in the waters of the United States.

‘(2) Contents- In conducting the study under paragraph (1), the
Administrator shall--

‘(A) identify PPCPs that have been detected in the waters of the
United States and the levels at which such PPCPs have been detected;

‘(B) identify the sources of PPCPs in the waters of the United States,
including point sources and nonpoint sources of PPCP contamination; and

‘(C) identify methods to control, limit, treat, or prevent PPCPs in
the waters of the United States.

‘(3) Report- Not later than 12 months after the date of enactment of
this subsection, the Administrator shall submit to Congress a report on
the results of the study conducted under this subsection, including the
potential effects of PPCPs in the waters of the United States on human
health and aquatic wildlife.

‘(4) Pharmaceuticals And Personal Care Products Defined- In this
subsection, the terms ‘pharmaceuticals and personal care products’
and ‘PPCPs’ mean products used by individuals for personal health or
cosmetic reasons or used to enhance growth or health of livestock.’.

Of the over 200 analytes in this project, 125 are pharmaceutical related
chemicals (pharmaceuticals, pharmaceutical metabolites or hormones). 
EPA personnel are currently compiling a review of studies conducted in
the United States and published between 2001 and January 2009 that
measured pharmaceutical related chemicals in wastewater, surface water,
and ground water (Kostich et al, in preparation).   In the literature
review, 110 pharmaceutical based chemicals were analytes in at least one
study.  Fifty-six of the 125 pharmaceutical based compounds in this
study overlap with those found in the literature review; over 60 of the
pharmaceuticals in our study have no reported occurrence information in
ground, surface, and waste-water in the United States.  An even smaller
number of chemicals have been measured in finished drinking water, and
chemical occurrence data are needed to assess the potential of effects
to human health, as outlined above.   If passed, H.R. 1262 provides a
very narrow window of time to produce a report on the occurrence of
pharmaceuticals in the nation’s waters, this study will be a valuable
asset to provide the most comprehensive, timely report possible.

Before commencing, this project was reviewed by panel consisting of two
independent reviewers from academia, two from the EPA-OW and one from
EPA Region IX and was found to be of use to the Agency.

Collective Comment 6: Data on Emerging Contaminants in Peer-Reviewed
Literature

Commenter A.   In recent years there have been many studies published in
the scientific literature concerning the occurrence of pharmaceuticals
and other emerging contaminants in the water environment. AMWA
recommends that the EPA include in the docket documentation about how
this study will advance the current body of knowledge and be useful for
the mission of the agency. If EPA plans to use the occurrence data to
build upon work that has already been done or build a database of
emerging contaminants, then this information should be conveyed.

The Water Research Foundation has a strategic initiative focusing on
various aspects of Endocrine Disrupting Compounds / Pharmaceuticals and
Personal Care Products (EDC/PPCP). Two projects in this initiative could
have an impact on EPA’s proposed work. One is a laboratory round robin
to determine commercial laboratory capabilities. The second is the
development and execution of a statistically based monitoring program
looking at a variety of EDC/PPCP inputs to the watershed.

Commenter B.   AWWA’s member utilities, EPA, the Water Research
Foundation, and numerous other entities are engaged in research on the
potential health effects and occurrence of an extraordinary list of
manmade and naturally occurring compounds. At present, the breadth of
that research is so large as to virtually preclude meaningful progress
toward federal risk management policy determinations. We urge that this
information collection effort (EPA ICR No. 2346.01) not proceed until
such time as an experimental design that offers a strong contribution to
EPA’s information needs can be clearly articulated and supported. In
our view, such a study must have clearly articulated hypotheses which
will be tested, demonstrate adequate statistical power to support its
conclusions, and data collection using methods of known precision and
accuracy. In reviewing the available data on “emerging contaminants”
the key data that would be most useful at this time is not additional
occurrence data, but whether there is any human toxicological relevance
at observed environmental concentrations.

	

Commenter C. The proposed plan appears to ignore extensive data that has
been collected over the past few years on the occurrence of emerging
contaminants by various organizations including some federal agencies.
Some, if not most, of those data collection efforts include more than
single event sampling and could provide more useful data.  Some of this
information is already available from EPA’s own databases, USGS
publications and possibly, source water assessment reports.

Response to Collective Comment 6

We disagree with the comments that there is sufficient information in
the scientific literature concerning the occurrence of emerging
contaminants, particularly pharmaceuticals, in the finished drinking
water of the United States.  While research has been conducted to
determine that such compounds can be present in finished drinking water,
much is yet to be understood in terms of fully documenting the full
range of chemicals present in source and finished drinking water, the
composition of complex mixtures of contaminants potentially present,
determining the effects of drinking water treatment, and understanding
important factors contributing to such contamination.

The USGS has published several studies related to drinking water
(Stackelberg et al., 2004, 2007; Focazio et al., 2008) documenting that
a wide range of emerging contaminants (including pharmaceuticals) are
present in source water and survive drinking water treatment.    Ye et
al (2007) sampled 24 antibiotics at three DWTPs, detecting six of them
at least once in the finished water.  Benotti et al (2009) has published
the most comprehensive study in the United States to date, targeting 51
compounds in 19 DWTPs; twenty of these chemicals, including nine
pharmaceuticals, were detected at least once in finished water.  In the
Associated Press’ series of articles on pharmaceuticals in drinking
water published in 2008, 34 out of 62 major metropolitan areas in the
United States have not tested their water for a single pharmaceutical. 
Clearly there is a deficit in the determination of occurrence of these
compounds in finished drinking water.

The EPA/USGS research of drinking water across the United States will be
targeting over 200 chemicals, more than 170 of which were not analytes
in the Benotti et al study.  One of the concerns with emerging
contaminants is not the presence of individual compounds, but the
potential effects of simultaneous exposure to complex mixtures of a wide
ranging of chemicals.  The comprehensive suite of chemicals analyzed in
concurrently collected samples will begin the process of identifying
what plurality of chemicals can exist in finished water.  

In October 2007, the American Water Works Research Foundation (now
renamed the Water Research Foundation (WRF)) convened a workshop to
prioritize research needs for pharmaceuticals and EDCs (  HYPERLINK
"http://www.waterresearchfoundation.org/research/TopicsAndProjects/Resou
rces/ResearchPlan/EDCStrategicInitiative/EDCWorkshopReport.pdf" 
http://www.waterresearchfoundation.org/research/TopicsAndProjects/Resour
ces/ResearchPlan/EDCStrategicInitiative/EDCWorkshopReport.pdf ).  More
than 30 experts  from the drinking water industry, academia, consulting
firms, and government in the field of pharmaceutical and EDC research
submitted  41 projects to be considered for future research; of these,
28 were fleshed out as potential projects to be funded by WRF.  A
project similar in scope to the EPA/USGS sampling program,
“Characterization of Source Water Quality, Finished Water Quality and
Treatment Process Effectiveness” was rated highest of the eight
projects Source Water Protection and Occurrence Focus Area, and was
overall ranked seventh out of the 28 projects.

The WRF project on analytical method inter-comparability was one of the
other 27 projects nominated at the 2007 workshop.   The round robin
project was nominated at the workshop by one of the PIs involved in the
EPA/USGS sampling project, and who is currently a member of the project
advisory committee.  As mentioned in the Response to Comment 4, this
project will also generate valuable information on interlaboratory
method comparability.   While this study will not have the same breadth
of participants as the WRF project, the uniformity in QA/QC parameters
the EPA/USGS study as well as the number of overlapping analytes (50)
will provide information that complements the WRF project.  As a team,
we are interested in the results of the WRF projects, and will monitor
the literature for their results.

Collective Comment 7:  Sampling Design 

Commenter A.   The Federal Register notice states that emerging
contaminants (ECs) “are chemicals… which are excreted from or washed
off the body and enter the wastewater treatment system.” This
statement is inaccurate, as many of the ECs of concern in our watersheds
are generated by other sources, such as agricultural business. AMWA also
suggests that the study include source water characterization at sites
considered to be point sources for these compounds. By the time many of
these contaminants reach drinking water intakes, their concentrations
have been attenuated by dilution, making them difficult to detect.
Characterizing point source discharges before they are diluted by the
receiving water is important information that can be used by EPA’s
water program in implementing the watershed approach framework.

Commenter B.   AWWA’s primary concerns are with respect to the first
three of these questions. The information provided in the docket
indicate that roughly 50 water systems will be provided a questionnaire
and that those same utilities will provide water samples for the
analysis of an unknown list of contaminants. EPA’s Safe Drinking Water
Information System (SDWIS) indicates that there are more than 51,970
community water systems (CWS) and an additional 102,865 non-community
water systems (NCWSs). More than 11,670 CWSs rely on surface water
supplies. Given the large number of water systems, it is not clear that
a sample design based on 50 locations would “have practical
utility.” It is worthwhile to note that EPA has a much more robust
sampling mechanism under the Safe Drinking Water Act (SDWA) known as the
Unregulated Contaminants Monitoring Rule (UCMR). EPA has successfully
used the UCMR mechanism to collect data from all systems serving greater
than 10,000 people and from a statistically valid sample of smaller CWSs
to guide federal drinking water policy development.

The available information suggests that a single influent and a single
finished water sample will be taken to characterize each participating
water treatment plant. If the agency anticipates utilizing the survey
data in combination with the measured occurrence data, then it seems
implausible that that the limited number of observations and the small
number of sample locations will support a meaningful analysis. Many
samples at each sample location would be needed to account for
differences in observed values due to the variability resulting from the
analytical method, elapsed time, and treatment processes. Indeed, if it
is the researcher’s intent to characterize treatment efficacy, then
typically pilot plant testing offers a much more robust experimental
design. Though, in both experimental approaches a much larger number of
samples is required to address inherent sources of variability.

Commenter C.  Furthermore, the study design implied by the ICR (a
one-time sampling event of source and treated water at each of 50
drinking water treatment plants - DWTPs) is not adequate to meet the
intended goal of using the results to advise the EPA in determination of
chemicals to consider for future regulation.  We do not believe that 50
samples from volunteer water utilities (not selected through any sort of
stratified random sampling) will adequately characterize emerging
contaminant occurrence in any sort of meaningful way.  This approach
assumes that DWTPs deal with steady-state conditions and it also ignores
seasonal and analytical variability.  More frequent sampling for a year
(monthly?) at fewer sites is suggested as an alternative.

The Metro Utility Committee also has problems with the study’s
proposed use of paired (raw and finished water) sampling and a detailed
questionnaire/survey at each utility for EPA “to help interpret the
data collected during the water sampling program.”  The questionnaire
appears to be aimed at collecting information that could be used to draw
conclusions about treatability, as opposed to occurrence. Such
conclusions, we believe, would be inappropriate, given the limited
number of samples to be collected.

Consider the example of a contaminant that is detected in the source,
but not finished water, in a single paired sampling event.  This result
could be due to the treatment process removing or transforming the
contaminant.  It could also be due to fluctuating source water
contaminant concentrations and imperfect sampling timing. Or it could be
due to irreproducible analytical variability near the analytical
method’s detection limit (which is common when sampling for trace
contaminants).  Likewise, a contaminant that occurs in the finished
water but not the source water could have been a trace byproduct created
during treatment or contributed by treatment chemicals, or again, an
artifact of sample timing and source water contaminant level
fluctuations.  It could also be due to the cleaner finished-water matrix
allowing for improved detection.

Response to Collective Comment 7

The phrase “emerging contaminants” is an overarching term with no
formally established definition.  For this project, we are focused on
chemicals that are commonly used in households, and have defined
emerging contaminants as such.

We concede that the fact that this project will only involve sampling at
a minute percentage of the DWTPs in the United States.  The funding
needed to conduct a sampling exercise on the scale of the UCMR orders of
magnitude greater than available for this project.  Should the
legislation discussed in the response to Collective Comment 4 provide an
additional influx of funding for this project, we will increase the
number of sampling locations, as well as the number of target analytes. 
In designing this project, however, we have consciously made design
decisions to produce what was felt to be the most useful study possible
given the funding available.

As discussed in the response to Collective Comment 4, we have devoted a
large percentage of our budget to the analysis of QA/QC samples,
resulting in the generation of strongly defensible data.

It was decided that the project would be better served by maximizing the
number of DWTPs rather than repeated samplings at fewer utilities. 
However, up to five of the nine DWTPs mentioned in the response to
Collective Comment 3 will be re-sampled in this project.  While only 83
of the 205 analytes in this study were measured in the previous study,
this provides some information on the annual variability emerging
contaminants in source and finished waters.

As mentioned in the response to Collective Comment 1, the sampling
network is biased towards DWTPs that have a known or suspected
wastewater source in their drinking water resource.  Again, as funding
is limited, it was felt that the attention should be focused at the
upper boundary (worst case scenario) of potential detections and
concentrations in source and finished drinking water. DWTPs that draw
their source water from aquifers containing older water or have no
immediate waste source in their drinking water resource should be very
minimally impacted by the chemicals in this study. 

As noted above in the response to Collective Comment 5, the results
produced in this study will be one part of a comprehensive evaluation of
chemical occurrence data collected to evaluate whether a chemical should
be considered for evaluation under the CCL or UCMR.  Before any compound
would be considered for regulation in drinking water, they would be
thoroughly vetted through the CCL and UCMR processes. 

Statistical comparisons of source and finished water for individual
compounds will only be performed on the sample set as a whole, using
nonparametric statistical tests, such as the Wilcoxon paired sample
test.

 EPA Action Resulting from Public Comment

	In response to the comments received to the first Federal Register
Notice, we have made the following changes to the ICR package:

Section 1(b), Short Characterization/ Abstract, has been modified to
include more details about the sampling project that is associated with
this information collection.

Section 6, Estimating the Burden and Cost of the Collection, has been
revised to include an initial phone interview, as well as to allow more
time to complete the questionnaire.

A file listing the methods that will be used on this project, as well as
the analytes of interest, has been included as Attachment B in the
supporting material in the docket. 

3(c) 	Consultations

	A smaller sampling project used an earlier draft of this questionnaire
in 2007.  The submissions of the nine respondents from that earlier
study were used to modify the questionnaire into its current form.

3(d) 	Effects of Less Frequent Collection

	This ICR is a one time only data collection activity for the
respondents.

3(e) 	General Guidelines

	

	The information gathered will be in accordance to the EPA’s
Guidelines for Ensuring and Maximizing the Quality, Objectivity,
Utility, and Integrity of Information Disseminated by the Environmental
Protection Agency.  These guidelines were developed by the EPA to comply
with the Office of Management and Budget Guidelines (67 FR 8451,
February 22, 2002).	

3(f) 	Confidentiality 

	The finished questionnaires will not contain any data that should be
considered as confidential business information. The questionnaires will
be collected and maintained by a single principal investigator.  Every
DWTP will be assigned a number (such as DWTP 1) to maintain anonymity in
data presentations and publications.  The DWTPs participating in the
study will be given a copy of the manuscripts generated during the study
prior to their publication.

3(g) 	Sensitive Questions

	No sensitive questions pertaining to a personal nature will be asked in
the questionnaire.

4. 	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a) 	Respondents

	

The respondents for this study will be a maximum of 50 DWTPs operating
in the U.S. and U.S. territories.

4(b) 	Information Requested

	

(i) Data Items

	The questionnaire and phone survey used in this study are attached as
Attachments C and D.  The data to be collected fall into four different
categories: 1) utility contact information; 2) utility geographic and
demographic information; 3) utility treatment information and 4) general
water quality parameters already monitored by the utility at time of
sampling.  

(ii) Respondent Activities

	Prior to selection, each DWTP will participate in a phone interview to
determine if the facility is an acceptable candidate for the project. 
Once selected, each respondent will receive an electronic copy of the
questionnaire when they are notified that sampling supplies have been
shipped to their location.  Included with the sampling supplies will be
a second hard copy of the questionnaire.  Detailed instructions will be
provided on how to collect and package samples of the DWTP’s source
and finished water.  The questionnaire should be completed concurrent
with sampling.  The current water quality parameters requested in Part D
of the questionnaire are routinely monitored by DWTPs.  The geographic,
demographic and treatment information should be historical information
the utility has in their records.  Respondents may complete and submit
the questionnaire either electronically or by mail, with the electronic
submission preferred.

5.	THE INFORMATION COLLECTED- AGENCY ACTIVITIES, COLLECTION METHODOLOGY,
AND INFORMATION MANAGEMENT

5(a)	Agency Activities

	The EPA’s Office of Research and Development will be responsible for
administering the questionnaire, answering respondent questions,
reviewing respondent answers, and analyzing and storing the data.

5(b) 	Collection Methodology and Information Management

	Each participating DWTP will receive both an electronic and hard copy
of the questionnaire.  The DWTP can complete the questionnaire by
legibly handwriting or typing the responses in the spaces provided, or
they may use the electronic version.  The questionnaires may be returned
via first class mail or e-mail, with electronic submissions preferred.

	EPA will include an e-mail address and phone number in the instructions
that respondents can use to request assistance in completing the
questionnaire. Using these assistance methods enables the respondents to
receive a timely response to any inquiries that they may have. E-mail
and telephone communication will also reduce any misinterpretations of
the questionnaire and thus decrease the burden of follow-up phone calls
and letters to the respondents. 

Upon receipt of completed questionnaires, EPA will review the
questionnaires for completeness.

5(c) 	Small Entity Flexibilty

	Many, if not most, of the DWTPs that will be respondents to this ICR
can be classified as small businesses under the Small Business
Administration’s size standards. The EPA has taken several steps to
minimize the burden of responding to this questionnaire for all
respondents, including small businesses.  The questions are phrased with
commonly used terminology, and examples of the type of answers that are
requested are given.  Questions of a similar nature are arranged
together to facilitate review of pertinent records.

5(d)	Collection Schedule

	After OMB approval, between one and three respondents will be contacted
each week, and they will each have two weeks to return the
questionnaire.  Therefore, collection is expected to require a maximum
of 365 days. 

6. 	ESTIMATING THE BURDEN AND COST OF THE COLLECTION 

6(a)  	Estimating Respondent Burden

	Based on discussions with the respondents to previous questionnaires,
it is estimated that each utility will spend an average of 19 hours
completing the questionnaire.  In addition, there will be a 1 hour phone
pre-interview to explain the project to the DWTPs, inquire about some
general information about the DWTPs to determine if they would be
acceptable candidates for the project, as well as to ascertain if the
DWTPs would want to participate in the study.  This burden will likely
be spread among several labor categories, both managerial and technical.
 The Agency estimated the required response time for each labor category
in Table 1.  The overall project burden is expected to be 1000 hours.

TABLE 1.  ESTIMATED ANNUAL RESPONDENT BURDENS AND COSTS

Respondent Job Category	Median Annual Salary	Calculated Hourly Salary
Per Site

Burden Hours	Per Site Cost	Estimated Number of Respondents	Overall
Project Burden Hours	Overall Project Cost

Operations and Maintenance Executive	$83,317	$40.06	2	$80.12	50	100
$4,006

Water Operations Manager	$61,373	$29.51	8	$236.08	50	400	$11,804

Water Quality/ Laboratory Manager	$56,877	$27.35	10	$273.50	50	500
$13,675

Total

	20	$589.70

1000	$29,485

6(b)	Estimating Respondent Costs

(i) Estimating Labor Costs	

Hourly salaries for each of the job categories expected to be impacted
by this questionnaire were calculated using median annual salaries
reported by the American Water Works Association (  HYPERLINK
"http://www.awwa.org/careercenter/resources/docs/JobDescriptions.cfm" 
http://www.awwa.org/careercenter/resources/docs/JobDescriptions.cfm  
Accessed March 4, 2009).  These salaries are presented in Table 1. 
Using this data, costs are estimated to be $589.70 per location,
resulting in an overall project cost of $29,485.

(ii) Estimating Capital and Operations and Maintenance Costs

	The EPA is not requiring the purchase of any equipment or machinery to
respond to the questionnaire, therefore capital costs are not expected. 
Operation and maintenance costs include only photocopying and postage
for completed questionnaires.

(iii) Capital/ Start-up and Operations and Maintenance Costs

	No capital or start-up costs should be associated with this project. 
The operation and maintenance costs will only be incurred by utilities
that choose not to respond electronically.  The EPA estimates copying
charges of $1.00 and first class postage of $4.00 to return the
questionnaire.  This results in a total cost of $250 for all 50
respondents.

(iv) Annualizing Capital Costs 

	The EPA estimates that there will be no capital costs associated with
responding to the questionnaire.

6(c)	Estimating Agency Burden and Cost

	Table 2 presents an estimate of the burdens and costs that the Agency
will incur to prepare and administer the questionnaire, as well as
interpret the data generated during the project.  EPA salary costs are
based on an average GS 13 salary in Cincinnati, OH (  HYPERLINK
"http://www.opm.gov/oca/09tables/html/cin_h.asp" 
http://www.opm.gov/oca/09tables/html/cin_h.asp   Accessed March 4,
2009).

TABLE 2. ESTIMATED AGENCY BURDENS AND COSTS

Agency Activity	Burden Hours	Cost

(Assuming median rate of $45/ hour)

Prepare and format questionnaire

	10	$450

Publish notice of anticipated ICR in Federal Register and respond to
generated comments

	40	$1,800

Plan logistics and coordination

	500	$22,500

Identify and recruit utilities

	150	$6,750

Interagency agreement package preparation and submission

	30	$1,350

Quality assurance and quality control

	50	$2,250

Data interpretation and report preparation

	1000	$45,000

Totals	1780	$80,100

6(d) 	Estimating Respondent Universe and Total Burden and Costs

	The EPA expects to receive a maximum of 50 completed questionnaires. 
The total burden expected is 1000 hours, and the total labor and
operations and maintenance cost of 	$29,735 for all respondents.

6(e) 	Bottom Line Burden Hours and Costs

	Table 3 summarizes the total burdens and costs that the participating
DWTPs and the Agency will incur as a result of the information
collection.

TABLE 3. TOTAL ESTIMATED RESPONDANT AND AGENCY BURDEN AND COST SUMMARY

	Number of Respondents	Total Burden Hours	Total Labor Cost	Total
Operations and Maintenance Costs	Total Cost

DWTPs	50	1000	$29,485	$250	$29,735

EPA

1780	$80,100	0	$80,100

6(f)	Burden Statement

The EPA estimates that the total burden to the 50 DWTP operators for
responding to the questionnaire will be approximately 1000 hours, or
$29,735 (including labor and operations and maintenance costs). The EPA
estimates that there will be no start-up or capital costs associated
with completing and returning the questionnaire.

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 to collect, validate, and verify information, process and
maintain information, and disclose and provide information; adjust the
existing ways to comply with any previously applicable instructions and
requirements; train personnel 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,
the EPA has established a public docket for this ICR under Docket ID No.
EPA-HQ-ORD-2009-0114, which is available for public viewing at the
Research and Development Docket in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301 Constitution Ave., NW, Washington, DC.  The EPA
Docket Center Public Reading Room is open from 8:30 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
Research and Development Docket is 202-566-1752. An electronic version
of the public docket is available through   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov . Use
Regulations.gov to view and submit public comments, access the index
listing of the contents of the public docket, and to access those
documents in the public docket that are available electronically. Once
in the system, select “Advanced Search,” then key in the Docket ID
number identified above. Also, you can send comments to the Office of
Information and Regulatory Affairs, Office of Management and Budget, 725
17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for
EPA. Please include the EPA Docket ID No. (EPA-HQ-ORD-2009-0114) and OMB
control number (2080-NEW) in any correspondence.



PART B OF THE SUPPORTING STATEMENT

1. 	SURVEY OBJECTIVES AND KEY VARIABLES

1(a)	Survey Objectives

	This survey is designed to collect background and treatment information
from a small subset of the United States’ drinking water treatment
plants (DWTPs).  These DWTPs will potentially be participating in a
joint EPA/USGS research project to analyze source and finished drinking
water for a suite of chemical and microbial contaminants.  Survey
responses will be used to select DWTPs that will participate in the
sampling study, as well as provide operational information about the
DWTP that will permit interpretation of the analytical results and
comparison of locations.  

1(b)	Key Variables

	The information collected from the DWTPs will be gathered in three
segments: 1) a preliminary screening phone call, 2) the main
questionnaire, and 3) a detailing of the physical/ chemical properties
of the water samples at the time of collection.  For each of these
activities, the key variables are:

Screening Phone Call

Willingness to participate in the study

Ability to perform the required water sample collection activities

Abbreviated description of treatment process

Questionnaire

Information about the watershed the DWTP draws from, including sources
of wastewater and agricultural practices that may impact water quality
and current hydraulic conditions

Broad scale information on the population the DWTP serves

Detailed information on the treatment process, including parameters such
as pumpage at sampling, disinfectants used, and the distribution system 

 Sample Collection sheet

Time and date of collection

Common water quality parameters (which the DWTPs are already required to
monitor)

	These variables serve to document the qualitative characteristics of
each utility and will be used to better interpret the analytical data.

1(c)	Statistical Approach

	A statistical approach was not selected for this survey.  There are
over 160,000 entities in the United States that are subject to the Safe
Drinking Water Act.  In this study, we have the resources available to
analyze samples from a maximum of 50 locations, or approximately
0.031 % of total number of water providers.   As explained in the
response to Collective Comment 5 in Part A of the Supporting Statement,
the EPA can use the Unregulated Contaminant Monitoring Regulation (UCMR)
to gather a statistically representative sampling of DWTPs; however,
they can only monitor a maximum of 30 contaminants every five years. 
This study will be analyzing the water for over 200 contaminants.  The
water concentration data collected in this study may help the EPA’s
Office of Water choose the chemicals for consideration in future UCMRs.

	Although this project has a limited number of samples and is
intentionally biased towards those locations that have known or
suspected wastewater contributions in the source water, we will maximize
the diversity of the locations chosen to participate.  A preliminary
list of candidate DWTPs has been drafted and were selected to be diverse
in terms of geography, treatment technology, DWTP size, and population
served.

1(d)	Feasibility

	

	The questions asked of the DWTPs concerning the treatment performed at
their utility will require very little effort to compile.  For those
questions concerning the source watershed that the DWTP may find
slightly more difficult to answer, the questionnaire text prompts the
utility to supply additional contacts that may be able to better answer
the question.  

	If possible, the survey will be given to the DWTP and returned
electronically; if hard copies are required to be sent and returned, the
financial burden is minimal.  The funds required for the analysis have
already been acquired and committed.

	The survey will have to be completed just prior to or concurrently with
the water sampling at the DWTP.  If a utility cannot commit to filing
the paperwork at the time of sampling, they will not be included in the
study.

2.	SURVEY DESIGN

2(a)	Target Population and Coverage

	To assess the upper boundaries of concentrations of emerging
contaminants in source and finished drinking water in the United States,
we have targeted DWTPs that have known or suspected sources of
wastewater in their source water catchment.  

2(b)	Sample Design

(i) 	Sampling Frame	

		The DWTPs selected for the study will be drawn from a master list of
candidate facilities complied by the EPA and USGS project leads.  The
master list was assembled from a variety of sources including: 1) a EPA
document that lists communities with a high percentage of wastewater in
their source water (EPA-600/2-80-044); 2) locations sampled in previous
EPA and USGS studies known to contain contaminants; 3) nominations by
USGS and EPA field and regional personnel; 4) DWTPs that heard about the
project and volunteered; and 5) DWTPs mentioned in an Associated Press
report that had no emerging contaminant data.

(ii)	Sample Size

		As currently planned and funded, a maximum of 50 DWTPs will be sampled
in this study.  The majority of the costs associated with this study
will be spent on analyzing the water samples.  Even though the sample
design is biased towards locations that should have the chemicals we are
interested in studying, the concentrations are still expected to be very
low, typically in the parts-per-trillion range.  To provide the most
defensible data set possible, we chose to increase the number of quality
control samples that will be collected as part of the project, at a cost
of having fewer locations sampled.  For this project, for every primary
sample analyzed, a duplicate and a matrix spike sample will also be
analyzed.  Additionally, blank samples will be analyzed from every
location to monitor sampling contamination.  In all, over 70 % of the
samples analyzed in this project will be for quality control purposes.  

(iii)	Stratification Variables

		There are no stratification variables used for this project.

(iv)	Sampling Methods

		This project is not designed to be representative of the DWTP
community as a whole; it is intentionally biased to locations with known
sources of wastewater in its source water, with the specific purpose of
maximally characterizing potential wastewater impacts on source waters. 
Therefore, the nonrandom method of site selection is appropriate.

(v)	Multi-Stage Sampling

		This survey depends on the voluntary participation of DWTPs. 
Utilities contacted for the initial screening phone survey may choose
not to participate in the full study, or we may discover information
that would make them ineligible for this study.  Therefore, this study
will have two stages, 1) the screening phone survey and 2) the full
questionnaire.  For both stages, the sample design described above in
sections 2.b.i through 2.b.iv will apply.

2(c)		Precision Requirements

(i)	Precision Targets

	This project is not designed to provide a statistical projection to the
population of DWTPs at large.  Therefore, a target for precision is not
appropriate.

(ii)	Non-sampling Error

		The responses gathered in this survey are specific to each DWTP. 
Since this project is not designed to provide information on the
population as a whole, non-responses will not bias the results.

(iii)	Questionnaire Design

	The questionnaire used in this study is attached as Attachment C.  The
data to be collected fall into four different categories: Part A)
utility contact information; Part B) utility geographic and demographic
information; Part C) utility treatment information; and Part D) general
water quality parameters already monitored by the utility at time of
sampling.  Parts B through D will be used to determine why some
contaminants may be present in the source or finished water of one DWTP
but not another.  For example, the variation in detection could result
from differences in the composition of waste sources in the source
watershed, or differences in the treatment technologies used.  The
concentration of the analytes in this study can be influenced by the
physical or chemical water quality parameters requested in Part D; this
information is necessary to make meaningful comparisons between
locations.

	Most of the information supplied by the DWTPs will be very site
specific.  Therefore, the open-ended question format was an appropriate
choice for the majority of the questions.

	

3	PRETESTS AND PILOT TESTS

	This project is the second in a two phase project.  In Phase I,
conducted in 2007, nine DWTPs were sampled; all participants were given
an earlier version of this questionnaire.   Based on requests for
clarification from the Phase I DWTPs, the text of the questions were
modified.  The layout was also redesigned to facilitate both electronic
and hand-written responses.  

4	COLLECTION METHODS AND FOLLOW-UP

4(a)	Collection Methods

		

	Collection of information from the DWTPs is expected to include both
telephone interviews and completion of the questionnaire.  The contact
with the DWTPs is expected to follow the following scenario:

A candidate DWTP will be called, and in a short (5 minute) conversation,
the project will be briefly described.  If the DWTP is interested in
participating in the study, a contact e-mail or postal address will be
requested so that a fact sheet about the project, a listing of the
analytes that will be studied, and information about the methods to be
used can be sent.  An appointment for a more detailed call will also be
made.

In the second call, the entire EPA and USGS project team will
participate.  This call will give the DWTP an opportunity to ask
specific questions about the project.  It also gives the project team
the ability to evaluate the capability of the DWTP to collect the
requested samples, as well as find out general information about the
utility (for example, what disinfectant is used, but not the dosage or
anecdotal information about the watershed).  During this call, we will
notify the DWTPs that while we intend to maintain the anonymity of each
location during sampling, this project is a federal work product, and
therefore subject to freedom of information act (FOIA) requests.  At
this point, both the DWTP and the project team will determine if a
location will be included in the project.  Information from both the
first and second calls will be recorded on the Pre-questionnaire
telephone survey, provided as Attachment D.

The DWTP and project team will agree on a date for sample collection. 
The questionnaire will be sent to the utility in advance of the
collection.  Parts A though C can be completed in the week before
sampling; Part D should be filled out on the day of sampling.  The
completed form will be submitted with the samples to the EPA.

4(b)	Survey Response and Follow-up

	Due to the site selection process used for this project, a 100 %
response rate is expected.  The completed questionnaire will be reviewed
by the EPA and USGS project leads.  If any of the responses are unclear,
the DWTP will be contacted either by e-mail or telephone for
clarification.  

5	ANALYZING AND REPORTING SURVEY RESULTS

5(a)	Data Preparation

Due to the small number of sites sampled, and the variety of expected
answers, the questionnaires will be maintained as separate entities, and
not entered into a database.   However, an overview table will be
complied for use in data reports.  This table will likely consolidate
the following information: anonymous site identifier, source water type
(surface or ground water), source water level at sampling (high, low or
average), population served, pumpage at sampling maximum pumpage,
disinfectant, disinfectant dose, disinfectant residual, overview of
treatment steps and overall plant residence time.

5(b)	Analysis

	At the completion of the entire program, a joint USGS and EPA data
report will be produced that summarizes all of the contaminant
information collected in the study.  Several manuscripts interpreting
the results of the study will also be produced for publication in
peer-reviewed scientific journals.  These manuscripts may or may not use
the utility information collected as a part of this request to assist in
the data interpretation.  The participating DWTPs will each receive a
copy of the manuscripts, and will be permitted to provide comments prior
to submission for publication.

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