  SEQ CHAPTER \h \r 1 ICR SUPPORTING STATEMENT

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	TITLE AND NUMBER OF THE INFORMATION COLLECTION

National Water Quality Inventory Reports (Renewal).

EPA ICR No. 1560.08

	1(b)	SHORT CHARACTERIZATION

Section 303(d) of the Clean Water Act requires States to identify and
rank waters which cannot meet water quality standards (WQS) following
the implementation of technology-based controls.  Under Section 303(d),
States are also required to establish total maximum daily loads (TMDLs)
for listed waters not meeting standards as a result of pollutant
discharges.  In developing the Section 303(d) lists, States are required
to consider various sources of water-quality related data and
information, including the Section 305(b) State water quality reports.
The State Section 305(b) reports contain information on the extent of
water quality degradation, the pollutants and sources affecting water
quality, and State progress in controlling water pollution.

EPA’s Assessment and Watershed Protection Division (AWPD) works with
its Regional counterparts to review and approve or disapprove State
Section 303(d) lists and TMDLs from 56 respondents (the 50 States, the
District of Columbia, and the five Territories).  Section 303(d)
specifically requires States to develop lists and TMDLs “from time to
time” and EPA to review and approve or disapprove the lists and the
TMDLs.  EPA also collects State 305(b) reports from 59 respondents (the
50 States, the District of Columbia, five Territories, and 3 River Basin
commissions).

The Office of Management and Budget (OMB) previously approved
information collection authority for the submission of State 305(b)
reports under 40 CFR 130.10(a) of the EPA Water Quality Management
Standards under OMB Number 2040-0071 (ICR Number 1560.1). In 1992, OMB
approved an addendum to ICR 1560.1 clarifying the burden associated with
preparing State 303(d) lists of waters for inclusion in the 305(b)
reports.  OMB reapproved the ICR for the period 1993 -1995, 1996 - 1998,
1999 - 2003, and 2003-2007.

The agency encourages integration of reporting for 305(b) and 303(d)
into one report.  EPA has published guidance in 2001 for the 2002
reports; revised the guidance in 2003 for the 2004 reports (“Guidance
for 2004 Assessment, Listing and Reporting Requirements Pursuant to
Sections 303(d) and 305(b) of the Clean Water Act,” July 21, 2003);
and issued revised guidance for the 2006 reports on July 29, 2005
(“Guidance for 2006 Assessment, Listing, and Reporting Requirements
Pursuant to Sections 305(b), 303(d), and 314 of the Clean Water Act.”)
 EPA also issued updated guidance for the 2008 reports (“Information
concerning 2008 Sections 305(b), 303(d), and 314 Integrated Reporting
and Listing Decisions”) on October 12, 2006.

Since 2002, the Agency has encouraged States to combine the information
required by Section 303(d) and 305(b) in an “Integrated Report” and
to array the information among five specific categories of waters.
However, although the Agency recommends integration, throughout the bulk
of this supporting statement the 305(b) and 303(d) reports are discussed
separately to provide consistency with earlier information requests.

This Supporting Statement requests reapproval of current, ongoing
activities related to 305(b) and 303(d) reporting and TMDL development
for the period of December 1, 2007 through

November 30, 2010.

During the period covered by this ICR renewal, ongoing current
activities include:

respondents will complete their 2008 305(b) reports and 2008 303(d)
lists;

respondents will complete their 2010 305(b) reports and 2010 303(d)
lists;

respondents will transmit annual electronic updates of their 305(b)
databases in 2008 through 2010; and

respondents will continue to develop TMDLs according to their
established schedules;

EPA will update electronic state data on the Web;

EPA will prepare biennial Reports to Congress, post them on the Web, and
transmit them to Congress’

EPA will review TMDL submissions from respondents.

2.	NEED FOR AND USE OF THE COLLECTION

2(a)	NEED/AUTHORITY FOR THE COLLECTION

Section 303(d) of the CWA establishes the total maximum daily load
(TMDL) process to provide for more stringent water-quality based
controls when required controls are inadequate to achieve State water
quality standards. States must identify waters that do not or are not
expected to meet applicable water quality standards solely through the
implementation of technology based controls. These waters are referred
to as water-quality limited waters.

“(d)(1)(A)	Each State shall identify those waters within its
boundaries for which the effluent limitations required by section
301(b)(1)(A) and section 301(b)(1)(B) are not stringent enough to
implement any water quality standard applicable to such waters.  The
State shall establish a priority ranking for such waters, taking into
account the severity of the pollution and the uses to be made of such
waters.

           (B)	Each State shall identify those waters or parts thereof
within its boundaries for which controls on thermal discharges under
section 301 are not stringent enough to assure protection and
propagation of a balanced indigenous population of shellfish, fish, and
wildlife.

           (C)	Each State shall establish for the waters identified in
paragraph (1)(A) of this subsection, and in accordance with the priority
ranking, the total maximum daily load, for those pollutants which the
Administrator identifies under section 304(a)(2) as suitable for
calculation.  Such load shall be established at a level necessary to
implement the applicable water quality standards with seasonal
variations and a margin of safety which takes into account any lack of
knowledge concerning the relationship between effluent limitations and
water quality.

           (D)	Each State shall estimate for the waters identified in
paragraph (1)(B) of this subsection the total maximum daily thermal load
required to assure protection and propagation of a balanced, indigenous
population of shellfish, fish, and wildlife...”

Section 303(d)(2) requires States to submit the lists of water-quality
limited waters and associated TMDLs to the EPA “from time to time.”

“(2)	Each State shall submit to the Administrator, from time to time,
with the first submission not later than one hundred and eighty days
after the date of publication of the first identification of pollutants
under section 304(a)(2)(D), for his approval the waters identified and
the loads established under paragraphs (1)(A), (1)(B), (1)(C), and
(1)(D) of this subsection...”

 EPA’s Water Quality Planning and Management regulation (40 CFR 130)
defines “from time to time” as a biennial reporting requirement for
submitting prioritized lists of water-quality limited waters still
requiring TMDLs.  (Note that the regulatory revisions pertain
exclusively to 303(d) lists of waters requiring TMDLs and do not require
biennial submittals of TMDLs.) The regulations also specify that the
State submittals under Section 303(d) coincide with State submittals
under Section 305(b).

TMDLs are required for 303(d)-listed waters when other Federal, State
and local controls will not lead to the achievement of water quality
standards. TMDLs provide a rational method for weighing competing water
quality concerns and developing an integrated strategy for point and
nonpoint sources. TMDLs encourage a holistic view of water quality
problems considering all contributions to stream water quality and
provides a method to allocate those contributions so that water quality
standards will be met.

Section 305(b)(1) requires States to prepare and submit a biennial water
quality assessment report:

“(1)	Each State shall prepare and submit to the Administrator by April
1, 1975, and shall bring up to date by April 1, 1976, and biennially
thereafter, a report which shall include -

(A)	a description of the water quality of all navigable waters in such
State during the preceding year, with appropriate supplemental
descriptions as shall be required to take into account seasonal, tidal,
and other variations, correlated with the quality of water required by
the objective of this Act (as identified by the Administrator pursuant
to criteria published under section 304(a) of this Act) and the water
quality described in subparagraph (B) of this paragraph;

(B)	an analysis of the extent to which all navigable waters of such
State provide for the protection and propagation of a balanced
population of shellfish, fish, and wildlife, and allow recreational
activities in and on the water;

(C)	an analysis of the extent to which the elimination of the discharge
of pollutants and a level of water quality which provides for the
protection and propagation of a balanced population of shellfish, fish,
and wildlife and allows recreational activities in and on the water,
have been or will be achieved by the requirements of this Act, together
with recommendations as to additional action necessary to achieve such
objectives and for what waters such additional action is necessary;

(D)	an estimate of (i) the environmental impact, (ii) the economic and
social costs necessary to achieve the objective of this Act in such
State, (iii) the economic and social benefits of such achievement, and
(iv) an estimate of the date of such achievement; and

(E)	a description of the nature and extent of nonpoint sources of
pollutants and recommendations as to the programs which must be
undertaken to control each category of such sources, including an
estimate of the costs of implementing such programs.”

Under Section 314(a)(2), States must incorporate their Clean Lakes
Report into the 305(b) reports.  Section 314(a)(1) specifies the
contents of the Clean Lakes Reports:

“(1)  State program requirements.  – Each State on a biennial basis
shall prepare and submit to the Administrator for his approval  –

(A)	an identification and classification according to eutrophic
condition of all publicly owned lakes in such State;

(B)	a description of the procedures, processes, and methods (including
land use requirements) to control sources of pollution of such lakes;

(C)	a description of the methods and procedures, in conjunction with
appropriate Federal agencies, to restore the quality of such lakes;

(D)	methods and procedures to mitigate the harmful effects of high
acidity, including innovative methods of neutralizing and restoring
buffering capacity of lakes and methods of removing from lakes toxic
metals and other toxic substances mobilized by acidity;

(E)	a list and description of those publicly owned lakes in such State
for which uses are known to be impaired, including those lakes which are
known not to meet applicable water quality standards or which require
implementation of control programs to maintain compliance with
applicable standards and those lakes in which water quality has
deteriorated as a result of high acidity that may reasonably be due to
acid deposition; and

(F)	an assessment of the status and trends of water quality in lakes in
such State, including but not limited to, the nature and extent of
pollution loading from point and nonpoint sources and the extent to
which the use of lakes is impaired as a result of such pollution,
particularly with respect to toxic pollution.

(2)	Submission as Part 305(b)(1) Report. –  The information required
under paragraph (1) shall be included in the report required under
section 305(b)(1) of this Act, beginning with the report required under
such section by April 1, 1988.”

Section 106(e) requires States to include information on monitoring
activities implemented to evaluate the quality of surface waters and
ground water in the 305(b) reports:

“(e)  Beginning in fiscal year 1974 the Administrator shall not make
any grant under this section to any State which has not provided or is
not carrying out as a part of its program

(1) the establishment and operation of the appropriate devices, methods,
systems, and procedures necessary to monitor, and to compile and analyze
data on (including classification according to eutrophic condition), the
quality of navigable waters and to the extent practicable, ground waters
including biological monitoring; and provision for annually updating
such data and including it in the report required under section 305 of
this Act;”

	2(b) USE / USERS OF THE DATA

The 305(b) reporting process is an essential component of the EPA water
pollution control program.  EPA’s Monitoring Branch of the Assessment
and Watershed Protection Division (AWPD) uses the State reports as the
principal information source for assessing nationwide water quality, the
progress made in maintaining and restoring water quality, and the extent
of remaining water pollution problems.  AWPD prepares the National Water
Quality Inventory Report to Congress and evaluates impacts of EPA’s
water pollution control programs with the information and data supplied
in the State 305(b) reports and the Assessment Database (ADB).  The
Office of Water uses the Report to Congress to target persistent and
emerging water quality problems with new initiatives and to improve or
eliminate ineffective programs.

The Watershed Branch of AWPD uses the information submitted under
Section 314 to evaluate the status of lake water quality in reports
issued by the Section 314 Clean Lakes Program.

In addition to AWPD, several branches within EPA utilize the ADB
database.  EPA Regional permit enforcement branches have used the ADB to
verify that State NPDES (National Pollutant Discharge Elimination
System) permits address causes and sources of pollution in degraded
waters.  Others, such as the Great Lakes Task Force, can use the ADB
database to summarize water pollution information by interstate and
interregional hydrological units.  Other agencies, including the
National Oceanic and Atmospheric Administration (NOAA) and the U.S.
Department of Agriculture, have used ADB data to summarize the extent of
water quality problems in coastal waters and the national extent of
watersheds impaired by agricultural nonpoint sources.  Also, the
respondents use the ADB and other assessment databases in their water
quality management programs to identify problem areas, track progress in
pollution control, and to set priorities.

The Watershed Branch of AWPD uses the information submitted under
Section 303(d) to track State progress in preparing TMDLs for
water-quality limited waters still requiring TMDLs. Consistent with the
requirements of Section 303(d), the Watershed Branch of AWPD and its
Regional counterparts review the Section 303(d) lists submitted by the
States to review whether they comply with the requirements of the
statute and EPA’s regulations and reflect an accurate State-by-State
accounting of waters not meeting water quality standards (WQS) after the
application of technology-based controls. Also as required by Section
303(d), EPA reviews TMDLs developed and submitted by the States to
determine their technical sufficiency and whether they otherwise comply
with the requirements of Section 303(d) and the EPA regulations.

3.	THE RESPONDENTS AND THE INFORMATION REQUESTED

3(a)	RESPONDENTS / NAICS CODES

The respondent community for 305(b) reporting consists of 50 States, the
District of Columbia, 5 Territories (Puerto Rico, the Virgin Islands,
Guam, American Samoa, and the Northern Mariana Islands), and 3 River
Basin Commissions.  The Ohio River Valley Sanitation Commission, the
Delaware River Basin Commission, and the Interstate Sanitation
Commission have jurisdiction over basins that lie in multiple States for
the purposes of 305(b) reporting only.  The NAICS code for respondents
is 92411 (Administration of Environmental Quality Programs: Air and
Water Resources and Solid Waste Management).  Tribes are not required to
submit 305(b) reports. However, to meet the needs of Tribes at all
levels of development, EPA has prepared Guidance that presents the basic
steps a Tribe should take to collect the water quality information it
needs to make effective decisions about its program, its goals, and its
future directions.  Tribal water quality monitoring and reporting
activities are covered under the Section 106 Tribal Grants Program and
not included in the burden estimates for this ICR.

The respondent community for 303(d) activities consists of 50 States,
the District of Columbia, and 5 Territories (Puerto Rico, the Virgin
Islands, Guam, American Samoa, and the Northern Mariana Islands).2  The
NAICS code for respondents is 92411 (Administration of Environmental
Quality Programs: Air and Water Resources and Solid Waste Management).
Although Indian Tribes can be authorized to meet 303(d) requirements,
none are currently authorized nor have applied for authorization.
Further, very few Tribes have established water quality standards.
Therefore, we assume that there would no burden to Indian Tribes over
the period covered by this ICR for 303(d) activities.

In summary, there are 56 respondents for 303(d) activities (including
TMDL development activities) and 59 respondents for 305(b) reporting (56
respondents, plus 3 River Basins with only 305(b) reporting
requirements).

3(b)	INFORMATION REQUESTED

	(i)	Data Items

The 305(b) report can serve as an “umbrella” to encompass a broad
range of information and data on water quality required by the CWA.  The
respondents will report on the following items in their 305(b) reports
(the CWA section requiring each item is highlighted in brackets):

1.	A description of the State’s water quality [Section 305(b)(1)(A)].
Respondents will include both narrative descriptions and numerical
summary tables for this item, as specified in EPA’s Guidance for 2004
Assessment, Listing and Reporting Requirements Pursuant to Sections
303(d) and 305(b) of the Clean Water Act” July 21, 2003.  EPA requests
that the States describe water quality in terms of the support of
beneficial uses (e.g., aquatic life use, swimming use, drinking water
supply use).  CWA Section 303(c) requires States to designate standards
(comprised of beneficial uses paired with criteria for attaining each
use) to all navigable waters of the State.  Each beneficial use has its
own criteria for defining the degree of support (i.e., whether the water
is fully supporting  a beneficial use or impaired for that use).  For
example, a State aquatic life criterion for selenium might be “no
greater than a concentration of 20 micrograms per liter" while the
drinking water criterion for selenium might be "no greater than 50
micrograms per liter.”  In this State, a water with consistent
selenium concentrations of 40 micrograms per liter could fully support
the drinking water use but not the aquatic life use.

		2.	An analysis of attainment of the CWA fishable and swimmable goals
[Section 305(b)(1)(B)].  The fishable goal strives for the protection
and propagation of a balanced population of shellfish, fish and wildlife
in the nation’s navigable waters.  The swimmable goal seeks water
quality that can support safe recreational use in and on the nation’s
waters.  To minimize duplication of effort, EPA requests that States
define attainment of the CWA fishable and swimmable goals in terms of
support of beneficial uses.  As a result, States can satisfy CWA goal
reporting requirements while describing beneficial use support.

		3.	Recommendations of additional actions needed to achieve the
fishable and swimmable goals of the CWA, and a list of the waters where
additional actions are needed [Section 305(b)(1)(C)].  EPA requests that
States define waters needing additional action as those waters partially
supporting, not supporting, or unable to attain their beneficial uses.
To identify additional actions needed to meet the goals of the CWA, EPA
requests that the States identify and list the pollutants causing less
than full support of beneficial uses (e.g., dissolved oxygen, pH,
temperature, toxic contaminants), and the sources of pollutants causing
less than full support (e.g., municipal point sources, combined sewer
overflows, agricultural runoff, urban runoff).

		4.	An estimate of the environmental impact, the benefits and economic
and social costs of achieving the CWA goals in the State, and an
estimate of the date when the State will achieve the goals [Section
305(b)(1)(D)].  The EPA recognizes that this information may not be
readily available due to the complexities of the analyses involved.
Therefore, respondents provide information (to the extent possible) on
the costs of pollution control activities, capital investment in
municipal and industrial facilities (including the costs of operating
these facilities), and the costs of administering State and local water
pollution control activities.  Respondents also provide, if possible,
information on the beneficial actions taken to maintain or improve water
quality conditions.

		5.	A description of nonpoint sources of pollutants degrading water
quality and recommendations for controlling each nonpoint source
category [Section 305(b)(1)(E)].  To minimize burden, EPA suggests that
States address this requirement by updating the nonpoint source
assessment reports required under Section 319 of the CWA.

		6.	A list of water-quality limited waters needing TMDLs [Section
303(d)(1)].  States are required to establish a priority ranking for
these waters taking into account the severity of the pollution problems
and the designated uses of each water.  In conformance with the CWA,
States apply individual approaches to assign priority to the order in
which TMDLs will be established for each identified water and targeted
for development during a specific period of time.

		7.	A list of publicly-owned lakes ranked by trophic status and a list
of significant publicly-owned lakes with impaired water quality,
including lakes affected by high acidity [Sections 314(a)(1)(A) and
314(a)(1)(E)].  Summary statistics on impaired and threatened lakes can
be reported separately or in conjunction with information on beneficial
use support for navigable waters described under item 1 above.

		8.	A description of methods implemented to control sources of
pollution and restore water quality in publicly-owned lakes [Sections
314(a)(1)(B) and 314(a)(1)(C)].

		9.	A description of methods to mitigate high acidity in lakes [Section
314(a)(1)(D)].

		10.	An assessment of the status and trends of lake water quality
[Section 314(a)(1)(F)].

		11.	A description of groundwater quality (in narrative and
quantitative form) [Section 106(e)].

		12.	A description of State monitoring programs designed to evaluate
surface water quality and groundwater quality [Section 106(e)].

					13.	Annual electronic datasets containing information for each
assessed water used to prepare the summary information in the items 1,
2, 3, 5, and 7 above.  These can be ADB datasets or datasets in a format
that EPA can convert electronically to ADB.

In accordance with Section 303(d)(1), States submit to EPA for review
and approval/disapproval action a list of waters not attaining standards
after the application of technology-based controls. The statute requires
States to establish a priority ranking for these waters taking into
account the severity of the pollution problems and the designated uses
of each water.  In conformance with the CWA, States apply individual
approaches to assign priority to the order in which TMDLs will be
established for each identified water.

In accordance with Section 303(d)(2), States establish TMDLs for waters
not meeting water quality standards as a result of pollutant discharges.
A TMDL is a written, quantitative assessment of water quality problems
and contributing pollutant sources. It specifies the amount that
pollutant loadings need to be reduced for the water to attain water
quality standards and allocates pollutant load reductions among sources
in a watershed. Section 303(d) requires States to submit TMDLs to EPA
for review and approval/disapproval action.

	(ii)	Respondent Activities

During the period covered by this ICR renewal, the three respondents
with only 305(b) reporting requirements will complete their 2008 305(b)
reports and their 2010 305(b) reports.  The remaining 56 respondents
will complete their 2008 305(b) reports; their 2008 303(d) lists; their
2010 305(b) reports; and their 2010 303(d) lists, preferably in an
integrated report.  During this period, all 59 respondents will also
transmit annual electronic updates of their 305(b) databases in 2008
through 2010.  The 56 respondents with 303(d) responsibility will
continue to develop TMDLs according to their established schedules.  The
specific activities that respondents undertake as part of their 305(b)
and 303(d) programs are derived from an ongoing project among EPA,
States and other interested stakeholders to develop a tool for
estimating the States’ resource needs for State water quality
management programs.  This project has developed the State Water Quality
Management Workload Model (SWQMWM), which estimates and sums the
workload involved in more than one hundred activities or tasks
comprising a State water quality management program. For the purposes of
305(b) and 303(d) activities, EPA assumes that all respondents
(including territories and river basins) are adequately represented by
the level of needs reported by States in the SWQMWM.  According to the
SWQMWM, the States will carry out the following activities or tasks to
meet the 305(b) and 303(d) reporting requirements.  In general,
respondents have conducted each of these reporting and record keeping
activities for past 305(b) and 303(d) reporting cycles and thus have
staff and procedures in place to continue their 305(b) and 303(d)
reporting  programs.

Activities for 56 Respondents with Both 305(b) and 303(d)
Responsibility:

		1. 	Review Regulations and Guidance for CWA 305(b) and CWA 303(d).

2. 	Plan and Coordinate Data Acquisition and Compile and Screen Data for
Assessments.  Specific activities include: planning data acquisition
strategy; issuing solicitation for data from other agencies,
universities, the public, etc.; developing data screening programs;
gathering and compiling appropriate data; and determining the
availability of sufficient data.

3. 	Develop and Submit Complete 305(b) Report and Respond to EPA
Comments. Specific activities include:  internal circulation, review,
and revision of all aspects of the report prior to submission to EPA and
information regarding the ability of each individual water (including
rivers and streams, lakes, estuaries, wetlands, and coastal and marine
waters) to meet its designated use.

4.  	Develop, Review, and Update 303(d) Assessment Methodology.

5.  	Prepare 303(d) List.  Specific activities include:  identifying
waters (including wetlands and coastal and marine waters), establishing
priorities, and determining schedules and targets.

6.  	Conduct Public Participation Required for the 303(d) list.
Specific activities include:  issuing public notice(s) and developing
responses to public comments on the list, priorities, and schedules.

7.  	Submit 303(d) List to EPA and Respond to EPA Comments.

8.  	Prepare Annual Electronic Updates.  This activity includes
inputting geo-referenced assessment findings into the Assessment
Database (or a compatible format) and submitting that database to EPA on
an annual basis.

Activities for 3 Respondents with 305(b) Responsibility Only:

1. 	Review Regulations and Guidance for CWA 305(b) and CWA 303(d).

2. 	Plan and Coordinate Data Acquisition and Compile and Screen Data for
Assessments.  Specific activities include: planning data acquisition
strategy; issuing solicitation for data from other agencies,
universities, the public, etc.; developing data screening programs;
gathering and compiling appropriate data; and determining the
availability of sufficient data.

3. 	Develop and Submit Complete 305(b) Report and Respond to EPA
Comments. Specific activities include:  internal circulation, review,
and revision of all aspects of the report prior to submission to EPA and
 information regarding the ability of each individual water (including
rivers and streams, lakes, estuaries, wetlands, and coastal and marine
waters) to meet its designated use.

8.  	Prepare Annual Electronic Updates.  This activity includes
inputting geo-referenced assessment findings into the Assessment
Database (or a compatible format) and submitting that database to EPA on
an annual basis.

An additional activity not included in the SWQMWM involves an enhanced
assessment of the benefits and costs of achieving water quality goals.
The program requires that the 305(b) biennial water quality reports
include an estimate of the environmental impact, the benefits and
economic and social costs of achieving the CWA goals in the State, and
an estimate of the date when the State will achieve the goals. In
previous ICRs, EPA has recognized that this information may not be
readily available due to the complexities of the analysis involved.
Therefore, respondents provide information (to the extent possible) on
the costs of pollution control activities, capital investment in
municipal and industrial facilities (including the cost of operating
these facilities), and the costs of administering State and local water
pollution control activities. Respondents also provide, if possible,
information on the beneficial actions taken to maintain or improve water
quality conditions. As a Term of Clearance for a previous ICR (1560.05),
OMB required that an estimate be made of the burden that would be
associated with all States estimating costs and benefits for achieving
WQS.  These activities have not yet been implemented pending revisions
to the program; they are included in this ICR.  Thus, this ICR estimates
the burden to the Agency of providing respondents with data, methods,
templates and workshops for use in estimating costs and benefits
(consistent with Section 305(b)(1)(D)), and the burden to all 59
respondents of applying this guidance to improve their  estimates.

In addition, 56 respondents with 303(d) responsibilities will conduct
activities associated with TMDL development.  The activities associated
with TMDL development have been analyzed in detail as part of the EPA
draft report, The National Costs to Develop TMDLs (Draft Report):
Support Document #1 (July 31, 2001).  These activities have been adapted
for the current ICR as detailed in Appendix C.  As described in Appendix
C, respondents will engage in the following activities to develop a TMDL
under the current 303(d) program.

1. 	Watershed characterization.  Compile available information, create
database or electronic files, review available information, and select
the technical approach.

2. 	Modeling and analysis.  Select final model, model setup and
calibration.  Evaluate existing conditions.

3. 	Allocation analysis.  Evaluate allocation scenarios and select final
allocation.

4. 	Development of TMDL document for public review.  Prepare technical
report documenting analysis and assumptions.  Document the TMDL (i.e.,
Waste Load Allocation (WLA), Load Allocation (LA), loading capacity,
margin of safety, seasonality).  Prepare administrative record.

5. 	Public outreach.  Public meetings and dissemination of information
prior to TMDL submittal.

6. 	Formal public participation. Announcement of TMDL and formal public
meeting.

7. 	Tracking, planning, legal support, etc.  Miscellaneous tasks needed
to support TMDL development.

The burden associated with these tasks under the program is estimated in
this ICR for the total number of TMDLs that may be submitted during the
period covered by this ICR.

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

	4(a)	AGENCY ACTIVITIES

		1.	Revise the Integrated Reporting guidance document for distribution
to the respondents. The guidance document provides essential
instructions to the respondents on the organization, format, and content
of the integrated 305(b)/303(d) reports. The guidance encourages the
States to submit information in a consistent format which enables EPA to
extract and summarize State information for the Report to Congress.
EPA’s most recent guidance document covers Integrated Reports due in
2008.

		2.	Prepare the National Water Quality Inventory Report to Congress.
AWPD will biennially consolidate the water quality assessment
information contained in the state Integrated Reports and electronic
updates into the Report to Congress.

		3.	Review the draft 305(b) reports.   EPA Headquarters staff and
Regional 305(b) Coordinators will review the draft submittals
biennially. The 303(d) lists of waters needing TMDLs will be forwarded
to the Regional 303(d) Coordinators for review.

4.	Review the final 305(b) reports.   Headquarters and Regional
personnel review the final 305(b) reports and electronic updates
biennially.

		5.	Review the annual electronic updates.   Headquarters and Regional
personnel review the electronic updates of State databases for data
quality and completeness and provide feedback to the States, and
incorporate these data into the national ADB files.  The national ADB
files will be used in preparation of the Reports to Congress.

		6.	Provide assistance to the States in implementing the ADB indexing.
EPA has provided technical support to States and other respondents for
implementing 305(b) assessment databases for over 12 years.  Initially,
the States needed extensive assistance to utilize the ADB database. In
1998, EPA upgraded the ADB to a user-friendly format and developed
on-screen tutorials, thereby reducing the need for direct user-support.
EPA is dedicated to upgrading the ADB to address needs specified by ADB
users and the IR guidance.  Since 1994, EPA also has provided technical
support to States for linking their 305(b) databases to the EPA Reach
File.  This support enables States to generate maps and do other spatial
analyses (e.g., summarize data at the watershed and reach level).  EPA
will continue this support, although at a reduced level as many States
have fully linked their 305(b) databases to the EPA Reach File.

		7.	Maintain the ADB database.  Maintenance activities include
preparation of user manuals; running quality control checks on
respondent datasets, and programming improvements to the ADB.  Other
activities include transferring electronic updates of State databases
into the national ADB files.  These national ADB files will be used in
preparation of the Reports to Congress to document types and locations
of water quality impairment and will be available to the public via the
Web.

8.	Prepare 303(d) guidance.

9.	Provide technical assistance to States for 303(d) listing.

10.	Review draft 303(d) lists.

11.	Review final 303(d) lists and resolve disapprovals.

In conformance with OMB’s Terms of Clearance for the current approved
ICR, this ICR includes the additional burden to the Agency associated
with developing guidance for States to use in estimating for their
305(b) biennial water quality reports, the benefits and economic and
social costs of achieving the CWA goals in the State.

With regard to TMDL submitted to EPA for approval: EPA must review and
act on the TMDL submissions within 30 days of the State submission and,
if it disapproves a State TMDL, EPA must issue a TMDL for the State
within 30 days of its disapproval.

	4(b)	COLLECTION METHODOLOGY AND MANAGEMENT

The respondents will submit their 305(b) and 303(d) reports in either
hard copy or electronic formats. The respondents will also submit their
use support information and 303(d) lists in a ADB-compatible format. EPA
developed the ADB to reduce the respondent burden associated with
summarizing use support information. The ADB also automates national
summaries needed to prepare the Report to Congress. The respondents may
submit their water-specific information by computerized data transfer or
by submitting their data on diskette to the Regional ADB Coordinator.

The States submit the Section 303(d) lists and priority rankings to the
EPA Regions. The Regions review the State submissions and then issue a
decision document approving or disapproving the State list. If EPA
disapproves a State list, it must issue a public notice identifying the
waters it is proposing to add to the State list.  In addition, States
must submit each completed TMDL to the EPA Regions for review and
action. If EPA disapproves the State submission, it must establish the
TMDL for the State.

The public can obtain a copy of the Report to Congress from the AWPD in
the EPA Office of Water or view it on the web at   HYPERLINK
"http://www.epa.gov/305b"  www.epa.gov/305b .  The public can obtain a
copy of the state 305(b) reports from the state websites, state contacts
or from the EPA Regional 305(b) Coordinators.

	4(c)	SMALL ENTITY FLEXIBILITY

This section is not applicable because the respondents are States and
Territories which are not small businesses or organizations as defined
by the Regulatory Flexibility Act, 5 U.S.C. Sections 601 (3) and (4).

	4(d)	COLLECTION SCHEDULE

	April 2008		States, Territories, and Commissions submit 2008 Integrated
305(b) and 303(d) reports to EPA and transmit annual electronic updates.

			April 2009	Respondents transmit interim annual electronic updates.

	December 2009	EPA submits the 2008 Water Quality Inventory Report to
Congress to OMB for approval

April 2010	States, Territories, and Commissions submit 2010 Integrated
305(b) and 303(d) reports to EPA and transmit annual electronic updates.

Ongoing	TMDL development and review

States are required to develop TMDLs consistent with the State schedule
and submit the TMDLs to EPA for review and approval/disapproval action.

5.	NONDUPLICATION, CONSULTATIONS. AND OTHER COLLECTION CRITERIA

	5(a)	NONDUPLICATION

The State 305(b) reports are the only direct vehicle for transmitting
water quality information between the States and EPA.  Although other
programs generate raw water quality data, the 305(b) reports are the
only information collection mechanism for obtaining beneficial use
support assessments.  Without the State 305(b) reports, EPA could not
report to Congress on national attainment of beneficial uses, as
required in the CWA.

The Section 303(d) lists are the only State-by-State public accounting
and ranking of waters not meeting water quality standards after the
application of technology-based controls. Under Section 303(d), States
must submit the Section 303(d) lists to EPA for review and
approval/disapproval action. TMDLs are a unique and valuable tool that
quantifies the maximum amount of a pollutant that a water can absorb and
still meet water quality standards. They specify the amount that
pollutant loadings need to be reduced for the water to attain water
quality standards and allocate pollutant load reductions among sources
in a watershed. Section 303(d) also requires EPA to review and approve
or disapprove State-submitted TMDLs.

5(b)	PUBLIC NOTICE REQUIRED PRIOR TO ICR SUBMISSION TO OMB

On July 31, 2007, a Federal Register notice (FRL 8447-9) required under
5 CFR 1320.8(d), solicited comments on this collection of information.
No comments were received.

	5(c)	CONSULTATIONS

EPA annually conducts a number of workshops with technical and
managerial state and territorial representatives around the country on
the use of the Assessment Database and the development of refinements
and updates based on the latest Integrated Reporting guidance.  Input
from states and territories is solicited at these workshops and on
regularly scheduled conference calls.  EPA is also in frequent contact
with state IR coordinators regarding approval/disapproval of 303(d)
lists and uploading/review/approval of IR data to the Assessment
Database.

EPA distributes the draft IR guidance to all respondents for comment
before issuing final guidance. EPA also solicits comments on the draft
guidance from other Federal agencies, both within and beyond EPA.

	5(d)	EFFECTS OF LESS FREQUENT COLLECTION

The biennial frequency of the collection is mandated by Section
305(b)(1) of the CWA. Section 305(b) originally required respondents to
submit water quality reports on an annual basis. In 1977, the annual
requirement was amended to a biennial requirement in the CWA.  EPA has
determined that abbreviated reporting for hard-copy 305(b) reports,
combined with annual electronic reporting using respondent databases,
will meet the CWA reporting requirements while reducing burden to
respondents.  The biennial period with annual electronic reporting
ensures that information needed for analysis and water program decisions
is reasonably current, yet abbreviated reporting requirements provides
respondents with sufficient time to prepare the reports.  Less frequent
collection would result in a declining level of State and EPA water
quality analyses because they would be based on outdated information.

	5(e)	GENERAL GUIDELINES

The proposed activities (i.e., collection of the State 305(b) reports
and 303(d) lists, preparation of the summary Report to Congress,
development and review of TMDLs, and preparation of the 305(b) guidance
document) do not include any information collection activities that
exceed Paperwork Reduction Act-imposed guidelines.

Information is not collected more often than quarterly.

Responses are not required in less than 30 days.

Respondents are not required to submit more than one original and two
copies of any document.

The collection does not provide for renumeration of respondents.

The collection does not require records to be kept for more than three
years.

The collection is not in conjunction with a statistical survey.

Provisions for small businesses and other small entities are
appropriate.

Confidentiality is protected.

The collection does not require submission of information in a format
other than that in which it is customarily maintained.

Regarding recordkeeping, EPA considers it appropriate that respondents
keep copies of their 305(b) reports and annual electronic updates for a
period of 3 years from the date they are transmitted to EPA.

5(f)	CONFIDENTIALITY AND SENSITIVE QUESTIONS

	(i)	Confidentiality

Information collected through the proposed activities is not
confidential because all respondents are State agencies, Territorial
agencies, Tribes, and public commissions working entirely in a public
forum.

		(ii)	Sensitive Questions

The proposed information collection activities do not request
information of a sensitive nature from the State respondents.

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a)	ESTIMATING RESPONDENT BURDEN

For current 305(b) and 303(d) reporting activities, the primary source
used in estimating burden is the State Water Quality Management Workload
Model (SWQMWM), which estimates and sums the workload involved in more
than one hundred activities or tasks comprising a State water quality
management program.  The SWQMWM was developed in 2002; the workload
burden estimates it generated remain applicable today.

The SWQMWM was designed to allow a State to enter its own values for
workload to be accomplished, FTE hours required to perform tasks, and
the average State salary per FTE hour.  Roughly half of the States used
the model to develop their own estimate of their program “needs.”
Twenty States used the model comprehensively, estimating their
task-by-task needs for performing all activities.  According to the
report on the model, “Though only one-third of States have submitted
data, these States provide a representative cross-section of State water
quality programs.  Participating States include large, medium, and small
States; have a great deal of geographic diversity; and face a wide
spectrum of water quality issues.”3 For this analysis, we use the
average “need” for a given task, estimated across these 20 States,
as our estimate for the burden required for a typical respondent to
perform this task.

Based on estimates derived from SWQMWM inputs, the average annual burden
per respondent for the 3 respondents that only have 305(b)
responsibility only is 2,969 hours.  The current burden for the 56
respondents with both 305(b) and 303(d) responsibilities is 6,491 hours
for both 305(b) and 303(d) reporting activities.  Worksheet 1 displays a
summary of the burden estimates and Appendix B provides details of the
calculations.

The SWQMWM does not include need estimates for one activity, an enhanced
assessment of the benefits and costs of achieving water quality goals.
The additional burden for respondents to assess the costs and benefits
of achieving water quality standards depends on the level of detail and
sophistication that the respondents choose to provide as well as factors
such as the number of impaired waters, the diversity of water resources,
and the intensity of use of those resources. Appendix B details the
estimate of the burden associated with the enhanced benefit cost
analysis, resulting in an average increase in respondent burden of 690
hours annually.

Thus, the total annual reporting burden for the 3 respondents with
305(b) responsibilities only is estimated at 3,659 hours (2,969 + 690).
The total annual reporting burden for the 56 respondents with both
305(b) and 303(d) responsibilities is 7,181 hours (6,491 + 690).  The
total annual burden for 305(b) and 303(d) reporting activities for all
respondents is 413,113 hours (3 @ 3,659 hours + 56 @ 7,181 hours).

We use a separate analysis to estimate the burden associated with
current TMDL development because the number and pace of TMDL development
varies greatly from State to State so that average responses in the
SWQMWM were thought to be inappropriate.  Instead, information from The
National Costs to Develop TMDLs (Draft Report): Support Document #1 is
updated to reflect current TMDL schedules.  Based on estimates of the
number of TMDLs per year (4,000), the total average current burden
associated with developing TMDLs under the current 303(d) program is
estimated to be 59,409 hours per respondent for the 56 respondents with
303(d) responsibility, and the total annual burden for all 56
respondents is estimated to be 3,326,904 hours.

Therefore, the total annual reporting burden for the 3 respondents with
305(b) responsibilities only is estimated at 10,977 hours (3@3659).  The
total annual reporting burden for the other 56 respondents with both
305(b) and 303(d) including TMDL development responsibilities is
3,729,040 (56@7181 + 56@59,409).  Finally, the total annual burden for
305(b) and 303(d) reporting activities for all respondents is 3,740,017
(10,977 + 3,729,040).

	6(b) ESTIMATING RESPONDENT COSTS

To estimate respondent costs, we applied an updated, average fully
loaded cost per hour to the burden estimates in Worksheet 1.  As part of
the SWQMWM development, States indicated the default value for a fully
loaded labor rate for a “typical” or “average” State.  This
fully loaded hourly labor rate represents the total cost for obtaining
an hour’s worth of work, and includes: direct salary paid, paid or
accrued vacation, paid or accrued sick leave, cost of other fringe
benefits (e.g., health, pension, etc.), general training, indirect
expenses such as professional support (e.g., clerical, accounting,
supervisory, etc.), office space, utilities, telephone service,
equipment (e.g., fax machines, basic computing needs such as hardware
and software, etc.), etc.. This rate does not include the costs
associated with computer maintenance, support or periodic upgrades of
hardware or software. Updating the original SWQMWM calculations, the
“typical” loaded labor rate identified as of November 2002 as $41.53
per hour. For 2007, we updated the default labor rate to reflect the
current time period by a factor of 1.1454 to derive a typical fully
loaded labor rate of $47.55 per hour.  This value is used to estimate
respondent costs in Worksheet 2.

The average annual cost to each respondent for current 305(b) and 303(d)
reporting (including the enhanced benefit cost activities) is estimated
to be $341,457 for the 56 respondents with 305(b) and 303(d)
responsibilities.  The average annual cost to the 3 respondents with
305(b) responsibility is $173,986.  The total annual cost imposed on all
59 respondents is estimated to be $19,643,523.

Average annual respondent costs for current TMDL development is
estimated at $2,824,898 per respondent for the 56 respondents with
303(d) responsibilities, and $158,194,285 for all 56 respondents
(Worksheet 2).

Therefore the total annual cost for all respondents is $177,837,808.

	6(c) ESTIMATING AGENCY BURDEN AND COST

Agency burden estimates are presented in Worksheet 3 and Agency cost
estimates are presented in Worksheet 4. The derivation of these
estimates is explained in detail in Appendix B.  The burden estimates
are based on AWPD’s prior experience in developing 305(b) and 303(d)
guidance, preparing the Report to Congress, providing technical support
to respondents, maintaining the ADB, and reviewing and
approving/disapproving 303(d) lists and TMDL submissions. The hourly
cost estimates were calculated for a technical federal position, Grade
10 Step 7 effective as of January 2007 ($24.58 per hour). The total
costs are based upon an overhead rate of 110 percent.  The average
annual Agency burden for 305(b) and 303(d) reporting activities is
estimated at 9,089 hours at a cost of $605,969.

The cost of the Agency’s additional burden to develop new guidance
required by States to improve their estimates of the benefits and costs
of achieving WQS is estimated at approximately $327,885 which would be
incurred during 2008 through 2010. Over the 3-year period of this ICR,
the annual cost would be $109,295 which translates into a burden of
2,117 hours annually.

The annual average Agency burden and costs for TMDL review is 11,200
hours and $578,144.

	6(d) BOTTOM LINE BURDEN HOURS AND COSTS / MASTER TABLE

	(i) Respondent Tally

		Annual Burden	3,740,017 hours per year

		Annual Costs 	$177,837,808 per year

	(ii) Agency Tally

		Annual Burden	22,406 hours per year

		Annual Costs 	$1,184,113 per year

	6(e) REASONS FOR CHANGE IN BURDEN

Changes in Burden for 305(b) and 303(d) reporting:  The total annual
respondent hour burden for 303(d) and 305(b) reporting has not changed
from ICR 1560.07.  In general, using the SWQMWM responses may result in
an overestimate of respondent burden because the responses represent
estimates of State need to fulfill program activities, rather than
actual spending.

Changes in Burden for TMDL development: The total annual respondent hour
burden associated with TMDL development has not changed from ICR
1560.07.

In short, the only changes associated with 303(d)/305(b) reporting and
TMDL development have been in cost due to rising wage rates from 2003 to
2007.

	6(f) BURDEN STATEMENT

Respondent reporting burden for this collection of information is
estimated to average 66,590 hours per year per respondent for the 56
respondents with both 305(b) and 303(d) responsibilities for existing
305(b) and 303(d) reporting activities and TMDL development activities.
The average burden for the 3 respondents with 305(b) responsibilities
only is estimated at 3,659 hours per year for 305(b) reporting
activities.  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 which have
subsequently changed; 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-OW-2003-0026, which is available for public viewing at the Water
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 Water Docket is (202)
566-2426.  An electronic version of the public docket is available
through http://www.regulations.gov.  Use www.regulations.gov to submit
or view 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 “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, DC 20503,
Attention: Desk Office for EPA.  Please include the EPA Docket ID No.
EPA-HQ-OW-2003-0026 and OMB Control Number 2040-0071 in any
correspondence.

PART B:   COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

	This section is not applicable because no statistical procedures are
employed for the information collection.Worksheet 1:  Burden Estimates
for Individual Respondents

	Burden by Year (Hours)	3-Year	Annual Average

Respondent Activities	Year 1

(10/07-9/08)	Year 2

(10/08-9/09)	Year 3

(10/09-9/10)	Total

 (10/07 – 9/10)	Total	Per Respondent

305(b) and 303(d) Reporting Activities

	Existing Program Activities

1.    Review regs and guidance	7,434 	7,434	7,434	22,302	7,434	126

2.    Plan and coordinate data acquisition	65,490 	65,490	65,490	196,470
65,490	1,110

3.    Develop/submit 305(b) report and respond to comments	83,013
83,013	83,013	249,039	83,013	1,407

4.    Develop, review and update 303(d) listing methodology	46,536
46,536	46,536	139,608	46,536	831

5.    Prepare 303(d) list 	123,648 	123,648	123,648	370,944	123,648
2,208

6.    Required public outreach for 303(d) list	14,840 	14,840	14,840
44,520	14,840	265

7.    Submission of 303(d) list and response to EPA comments	12,208
12,208	12,208	36,624	12,208	218

8.    Prepare annual electronic updates	19,234 	19,234	19,234	57,702
19,234	326

9.    Implement enhanced benefit cost of WQS	40,710	40,710	40,710
122,130	40,710	690

Total for 305(b) and 303(d) Reporting Activities		413,113	413,113
413,113	1,239,339	413,113	7,181

TMDL Activities

	Existing Program Activities

TMDL Development Activities	3,326,904	3,326,904	3,326,904	9,980,712
3,326,904	59,409

Total for TMDL Activities

		3,326,904	3,326,904	3,326,904	9,980,712	3,326,904	59,409

Total Burden for Existing Program Activities	3,740,017	3,740,017
3,740,017	11,220,051	3,740,017	66,590

	Note: The 3 respondents with 305(b) responsibilities only engage in
reporting activities numbered 1, 2, 3, 8, and 9.

Worksheet 2: Cost Estimates for Individual Respondents (based on a
loaded hourly rate of $47.55)

 	 	 	 	Burden by Year	 	 	Annual Average

Respondent Activities	(10/07-9/08)

Year 1	(10/08-9/09)

Year 2	(10/09-9/10)

Year 3	3-Year

Total	Total	Per Respondent

305(b) and 303(d) Reporting Activities

 	Existing Program

1.    Review regs and guidance	 $         353,487 	 $       353,487 	 $
     353,487 	 $       1,060,460 	 $         353,487 	 $          5,991

2.    Plan and coordinate data acquisition	 $      3,114,050 	 $
3,114,050 	 $    3,114,050 	 $       9,342,149 	 $      3,114,050 	 $
    52,781

3.    Develop/submit 305(b) report and respond to comments	 $
3,947,268 	 $    3,947,268 	 $    3,947,268 	 $     11,841,804 	 $
3,947,268 	 $        66,903

4.    Develop, review and update 303(d) listing methodology	 $
2,212,787 	 $    2,212,787 	 $    2,212,787 	 $       6,638,360 	 $
2,212,787 	 $        39,514

5.    Prepare 303(d) list 	 $      5,879,462 	 $    5,879,462 	 $
5,879,462 	 $     17,638,387 	 $      5,879,462 	 $      104,990

6.A. Required public outreach for 303(d) list	 $         705,642 	 $
  705,642 	 $       705,642 	 $       2,116,926 	 $         705,642 	 $
      12,601

7.    Submission of 303(d) list and response to EPA comments	 $
580,490 	 $       580,490 	 $       580,490 	 $       1,741,471 	 $
   580,490 	 $        10,366

8.    Prepare annual electronic updates	 $         914,577 	 $
914,577 	 $       914,577 	 $       2,743,730 	 $         914,577 	 $
    15,501

9.     Implement improved benefit cost analysis	 $      1,935,761 	 $
1,935,761 	 $    1,935,761 	 $       5,807,282 	 $      1,935,761 	 $
    32,810

Subtotal	 $    19,643,523 	 $  19,643,523 	 $  19,643,523 	 $
58,930,569 	 $    19,643,523 	 $      341,457

Total for 305(b) and 303(d) Reporting Activities	$19,643,523	$19,643,523
$19,643,523	$58,930,569	$19,643,523	$341,457

TMDL Activities

 	Existing Program

TMDL Development Activities	 $  158,194,285 	 $158,194,285
$158,194,285 	 $   474,582,856 	 $  158,194,285 	 $   2,824,898

Total for TMDL Activities	 $  158,194,285 	 $158,194,285 	 $158,194,285
 $   474,582,856 	 $  158,194,285 	 $   2,824,898

Total Burden for Existing Program Activities	 $  177,837,808
$177,837,808 	 $177,837,808 	 $   533,513,425 	 $  177,837,808 	 $
3,166,355

Note: The 3 respondents with 305(b) responsibilities only engage in
reporting activities numbered 1, 2, 3, 8, and 9.

Worksheet 3: Estimates of Agency Burden

	Burden by Year (Hours)	3-Year	Annual Average

Respondent Activities	Year 1

(10/07-9/08)	Year 2

(10/08-9/09)	Year 3

(10/09-9/10)	Total

 (10/07-9/10)	Total	Per Respondent

305(b) and 303(d) Reporting Activities

1.   Write 305(b) guidance	40	40	40	120	40	N/A

2.   Prepare Report to Congress	2,080 	2,080	2,080	6,240	2,080	N/A

3.   Review draft 305(b) reports	590 	590	590	1,770	590	N/A

4.   Review final 305(b) reports	177	177	177	531	177	N/A

5.   Review annual electronic updates of State databases	800 	800	800
2,400	800	N/A

6.   Assist States with ADB indexing	3,328 	3,328	3,328	9,984	3,328	N/A

7.   Maintain national ADB database	1,040 	1,040	1,040	3,120	1,040	N/A

8.   Prepare 303(d) guidance	62 	62	62	186	62	N/A

9.  Provide technical assistance to States for 303(d)	236 	236	236	708
236	N/A

10.  Review draft 303(d) lists	236 	236	236	708	236	N/A

11.  Review final 303(d) lists and resolve disapprovals	500 	500	500
1,500	500	N/A

12.  Guidance on enhanced benefit cost analysis	2,117	2,117	2,117	6,352
2,117	N/A

Total for 305(b) and 303(d) Reporting Activities			11,206	11,206	11,206
33,619	11,206	N/A

TMDL Activities

Review TMDLs and send notices to States	11,200	11,200	11,200	33,600
11,200	N/A

Total for TMDL Activities	11,200	11,200	11,200	33,600	11,200	N/A

Total Burden for Existing Program Activities		22,406	22,406	22,406
67,219	22,406	N/A

Worksheet 4: Estimates of Agency Cost (Based on an Average Loaded Hourly
Rate of $51.62)

Estimates of Agency Cost

 	 	 	 	 	 	 	Annual Average

Respondent Activities	(10/07-9-08)

Year 1	(10/08-9/09)

Year 2	(10/09-9/10)

Year 3	3-Year

Total	Total	Per Respondent

305(b) and 303(d) Reporting Activities

 	Existing Program

1.   Write 305(b) guidance	 $          2,065 	 $           2,065 	 $
   2,065 	 $          6,194 	 $         2,065 	N/A

2.   Prepare Report to Congress	 $     134,870 	 $       134,870 	 $
134,870 	 $     404,609 	 $     134,870 	N/A

3.   Review draft 305(b) reports	 $       30,456 	 $         30,456 	 $
    30,456 	 $       91,367 	 $       30,456 	N/A

4.   Review final 305(b) reports	 $          9,137 	 $           9,137
$        9,137 	 $       27,410 	 $         9,137 	N/A

5.   Review annual eletronic updates of State databases	 $       41,296
 $         41,296 	 $      41,296 	 $     123,888 	 $       41,296 	N/A

6.   Assist States with WBS indexing	 $     171,791 	 $       171,791
$    171,791 	 $     515,374 	 $     171,791 	N/A

7.   Maintain national WBS database	 $       53,685 	 $         53,685
$      53,685 	 $     161,054 	 $       53,685 	N/A

8.   Prepare 303(d) guidance	 $          3,200 	 $           3,200 	 $
     3,200 	 $          9,601 	 $         3,200 	N/A

9.  Provide technical assistance to States for 303(d)	 $       12,182
$         12,182 	 $      12,182 	 $       36,547 	 $       12,182 	N/A

10.  Review draft 303(d) lists	 $       12,182 	 $         12,182 	 $
  12,182 	 $       36,547 	 $       12,182 	N/A

11.  Review final 303(d) lists and resolve disapprovals	 $       25,810
 $         25,810 	 $      25,810 	 $       77,430 	 $       25,810 	N/A

12.  Enhanced benefit cost analysis	 $     109,295 	 $       109,295 	 $
   109,295 	 $     327,885 	 $     109,295 	N/A

Subtotal	 $     605,969 	 $       605,969 	 $    605,969 	 $  1,817,908
 $     605,969 	N/A

Total for 305(b) and 303(d) Reporting Activities	 $     605,969 	 $
 605,969 	 $    605,969 	 $  1,817,908 	 $     605,969 	N/A

TMDL Activities

 	Existing Program

Review TMDLs and send notices to States	 $     578,144 	 $       578,144
	 $    578,144 	 $  1,734,432 	 $     578,144 	N/A

Total for TMDL Activities	 $     578,144 	 $       578,144 	 $
578,144 	 $  1,734,432 	 $     578,144 	N/A

Total Agency Burden for All Activities	 $  1,184,113 	 $   1,184,113
$1,184,113 	 $  3,552,340 	 $ 1,184,113 	N/A

APPENDIX A: LANGUAGE OF THE CLEAN WATER ACT

Section 303(d)

(1)(A)	Each State shall identify those waters within its boundaries for
which the effluent limitations required by section 301(b)(1)(A) and
section 301(b)(1)(B) are not stringent enough to implement any water
quality standard applicable to such waters.  The State shall establish a
priority ranking for such waters, taking into account the severity of
the pollution and the uses to be made of such waters.

(B)	Each State shall identify those waters or parts thereof within its
boundaries for which controls on thermal discharges under section 301
are not stringent enough to assure protection and propagation of a
balanced indigenous population of shellfish, fish, and wildlife.

C)	Each State shall establish for the waters identified in paragraph
(1)(A) of this subsection, and in accordance with the priority ranking,
the total maximum daily load, for those pollutants which the
Administrator identifies under section 304(a)(2) as suitable for
calculation.  Such load shall be established at a level necessary to
implement the applicable water quality standards with seasonal
variations and a margin of safety which takes into account any lack of
knowledge concerning the relationship between effluent limitations and
water quality.

(D)	Each State shall estimate for the waters identified in paragraph
(1)(B) of this subsection the total maximum daily thermal load required
to assure protection and propagation of a balanced, indigenous
population of shellfish, fish, and wildlife...

(2)	Each State shall submit to the Administrator, from time to time,
with the first submission not later than one hundred and eighty days
after the date of publication of the first identification of pollutants
under section 304(a)(2)(D), for his approval the waters identified and
the loads established under paragraphs (1)(A), (1)(B), (1)(C), and
(1)(D) of this subsection..

Section 305(b):

(1)	Each State shall prepare and submit to the Administrator by April 1,
1975, and shall bring up to date by April 1, 1976, and biennially
thereafter, a report which shall include -

(A)	a description of the water quality of all navigable waters in such
State during the preceding year, with appropriate supplemental
descriptions as shall be required to take into account seasonal, tidal,
and other variations, correlated with the quality of water required by
the objective of this Act (as identified by the Administrator pursuant
to criteria published under section 304(a) of this Act) and the water
quality described in subparagraph (B) of this paragraph;

(B)	an analysis of the extent to which all navigable waters of such
State provide for the protection and propagation of a balanced
population of shellfish, fish, and wildlife, and allow recreational
activities in and on the water;

(C)	an analysis of the extent to which the elimination of the discharge
of pollutants and a level of water quality which provides for the
protection and propagation of a balanced population of shellfish, fish,
and wildlife and allows recreational activities in and on the water,
have been or will be achieved by the requirements of this Act, together
with recommendations as to additional action necessary to achieve such
objectives and for what waters such additional action is necessary;

(D)	an estimate of (i) the environmental impact, (ii) the economic and
social costs necessary to achieve the objective of this Act in such
State, (iii) the economic and social benefits of such achievement, and
(iv) an estimate of the date of such achievement; and

(E)	a description of the nature and extent of nonpoint sources of
pollutants and recommendations as to the programs which must be
undertaken to control each category of such sources, including an
estimate of the costs of implementing such programs.”

Section 314(a):

(1)	State program requirements.  – Each State on a biennial basis
shall prepare and submit to the Administrator for his approval  –

(A)	an identification and classification according to eutrophic
condition of all publicly owned lakes in such State;

(B)	a description of the procedures, processes, and methods (including
land use requirements) to control sources of pollution of such lakes;

(C)	a description of the methods and procedures, in conjunction with
appropriate Federal agencies, to restore the quality of such lakes;

(D)	methods and procedures to mitigate the harmful effects of high
acidity, including innovative methods of neutralizing and restoring
buffering capacity of lakes and methods of removing from lakes toxic
metals and other toxic substances mobilized by acidity;

(E)	a list and description of those publicly owned lakes in such State
for which uses are known to be impaired, including those lakes which are
known not to meet applicable water quality standards or which require
implementation of control programs to maintain compliance with
applicable standards and those lakes in which water quality has
deteriorated as a result of high acidity that may reasonably be due to
acid deposition; and

(F)	an assessment of the status and trends of water quality in lakes in
such State, including but not limited to, the nature and extent of
pollution loading from point and nonpoint sources and the extent to
which the use of lakes is impaired as a result of such pollution,
particularly with respect to toxic pollution.

(2)	Submission as Part 305(b)(1) Report. –  The information required
under paragraph (1) shall be included in the report required under
section 305(b)(1) of this Act, beginning with the report required under
such section by April 1, 1988.

Section 106:

(e)	Beginning in fiscal year 1974 the Administrator shall not make any
grant under this section to any State which has not provided or is not
carrying out as a part of its program –

(1)  the establishment and operation of the appropriate devices,
methods, systems, and procedures necessary to monitor, and to compile
and analyze data on (including classification according to eutrophic
condition), the quality of navigable waters and to the extent
practicable, ground waters including biological monitoring; and
provision for annually updating such data and including it in the report
required under section 305 of this Act;”

APPENDIX B: DERIVATION OF REPORTING BURDEN ESTIMATES

B.1 Respondent Burden Estimates for 305(b) and 303(d) Reporting
Activities

	For current 305(b) and 303(d) reporting activities, the primary source
we use in estimating burden for tasks to be performed by States is the
State Water Quality Management Workload Model (SWQMWM), which estimates
and sums the workload involved in more than one hundred activities or
tasks comprising a State water quality management program.

	The SWQMWM is designed to allow a State to enter its own values for
workload to be accomplished, FTE hours required to perform tasks, and
the average State salary per FTE hour.  Roughly half of the States
entered their own data and used the model to develop their own estimate
of their program “needs”.  Twenty States used the model
comprehensively, estimating their task-by-task needs for performing all
activities.  These 20 States appear to comprise a representative
cross-section of all States in terms of geography and size of their
water programs.  For this analysis, we use the average “need” for a
given task, estimated across these 20 States, as our estimate for the
burden required for a typical State to perform this task

	The following table summarizes the average of the annual need reported
by the 20 States in the SWQMWM.

Exhibit B-1 Average of Annual Need from SWQMWM for 305(b) and 303(d)
Reporting Activities

Activity	FTE-hrs/

Year/respondent	# of Respondents	Total Annual Burden

1.    Review regs and guidance for 305(b) & 303(d)	126	59	7,434

2.    Plan and coordinate data acquisition and compile and screen data
for assessments	1,110	59	65,490

3.    Development and submission of complete 305(b) report and response
to EPA comments	1,407	59	83,013

4.    Develop, review and update 303(d) listing and de-listing
methodology	831	56	46,536

5.    Prepare 303(d) list (includes identifying waters, setting
priorities, and schedules)	2,208	56	123,648

6.    Required public outreach for 303(d) list	265	56	14,840

7.    Submission of 303(d) list to EPA and response to EPA comments	218
56	12,208

8.    Prepare annual electronic updates	326	59	19,234

	Note: The 3 respondents with 305(b) reporting responsibilities only
engage in activities numbered 1, 2, 3, and 8.

 B.2 Respondent Burden Estimates for Implementing Enhanced Benefit Cost
Analysis of Meeting Water Quality Standards

	Section 305(b)(1)(D) of the CWA requires States in their biennial water
quality assessment to estimate the benefits and costs of achieving water
quality standards by estimating:

“i. the environmental impact,

ii. the economic and social costs necessary to achieve the objective of
this Act in such State,

iii. the economic and social benefits of such achievement and

iv. an estimate of the date of such achievement.”

	In previous ICRs, EPA recognized that this information may not be
readily available due to the complexities of the analyses involved.
Therefore, respondents provide information (to the extent possible) on
the costs of pollution control activities, capital investment in
municipal and industrial facilities (including the cost of operating
these facilities), and the costs of administering State and local water
pollution control activities. Respondents also provide, if possible,
information on the beneficial actions taken to maintain or improve water
quality conditions. States have provided varying degrees of information
in their biennial reports regarding the costs and benefits of achieving
WQS.

	As a Term of Clearance for the ICR covering the period March, 1999
through April 2003 (ICR Number 1560.05), OMB required that an estimate
be made of the burden associated with estimating benefits and costs
assuming that the Agency would provide additional guidance to States to
assist them in preparing the analyses. ICR Number 1560.07 included the
burden associated with the enhanced benefit cost analysis.
Uncertainties surrounding the 305(b) and 303(d) programs have made it
impractical to implement the enhanced benefit cost analysis for the 2004
or 2006 reports.  These activities may take place within future
reporting cycles as program uncertainties are resolved.

	The effort for benefits analysis for specific States depends on several
factors, including the number of impaired waters, differences in the
physical characteristics of these waters, differences in aquatic habitat
types, designated uses, and recreational importance as well the quality
of existing information about these waters. For a small state with a
small number of the 303(d) listed waters, low intensity of water-based
recreation, and nonexistent or negligible commercial fishing/shell
fishing, the cost of benefits assessment at the state and watershed
levels may not be very different. States with diverse water resources
and intensive uses of these resources (i.e., intensive water-based
recreation) such as coastal states are likely to incur larger costs due
to complexity of the benefits analysis. The level of effort associated
with developing estimates at the State level of the benefits of
attaining WQS are detailed in Exhibit B-1. As shown in the exhibit, the
Agency estimates that the range the burden associated with estimating
benefits at the State level ranges from 432 to 1,224 hours. Whether
States undertake Level 1, 2 or 3 analyses depends on the State policy
and on the complexity of the State’s watershed situations. Most
coastal watersheds and those Great Lakes watersheds would be more likely
to involve Level 3 analyses, while inland watersheds would be more
likely to be adequately addressed by Level 1 and 2 analyses.

Exhibit B-2  Hours of Effort to Estimate at the State Level the Benefits
of Attaining WQS

at 3 Levels of Difficulty

Task	Level 1	Level 2	Level 3

	Low	High	Low	High	Low	High

1. Characterize affected watersheds	96	120	128	144	160	192

2. Water quality modeling and analysis	64	80	96	112	128	144

3. Assess ecological improvements	32	48	56	64	64	72

Assess recreational improvements	32	40	56	64	72	88

Assess changes in nearby property values	16	24	32	40	48	56

Assess avoided cost of water treatment	24	32	48	64	64	80

Assess other economic productivity benefits	24	32	40	48	40	48

Assess human health benefits	16	24	32	40	40	48

4. Calibrate to local conditions*	---	---	---	---	160	192

5. Report writing	72	80	88	96	120	144

6. Contingency @ 15% **	56	72	88	104	136	160

Subtotal for Range	432	552	664	776	1,032	1,224

*interviews or pilot studies **Provision for additional data collection,
analysis, review, etc.

	We assume for this ICR that States will undertake efforts to estimate
costs that are similar to the efforts that they apply to estimate
benefits, amounting to an additional 432 to 1,224 hours.

	Therefore, the total burden per State associated is estimated to range
from 864 to 2,448 hours for the first report that will contain the
enhanced benefit cost analysis. The effort associated with the enhanced
benefit cost analysis will be considerably less for subsequent reports,
estimated to be only 25% of the effort associated with the initial
analysis (from 216 to 612 hours).

	For the period of this ICR, we assume that the full effort is incurred.
 Therefore, the total effort over the period of this ICR ranges from
1080 to 3060 hours per respondent. Annualizing over the three years
results in 360 to 1,020 hours annually per respondent. To estimate the
national cost, we assume that the average for the range represents the
typical level of analysis across all the 59 respondents for the purpose
of estimating a national burden, resulting in an average annual burden
of 690 hours.

 B.3 Agency Burden Estimates for 305(b) and 303(d) Reporting Activities

	 The Agency burden estimates associated with 303(d) and 305(b)
reporting activities are based on AWPD’s prior experience in
developing 305(b) and 303(d) guidance, preparing the Report to Congress,
providing technical support to respondents, maintaining the ADB, and
reviewing and approving/disapproving 303(d) lists and TMDL submissions.
Exhibit B-3 provides the basis for the estimates of Agency burden by
subtask.

Exhibit B-3. Agency Burden for 305(b) and 303(d) Reporting Activities

Activity	Total Annual Burden	Derivation

1.   Write 305(b) guidance	40	Reduction in hours because guidance is
complete and only minor revisions are anticipated

2.   Prepare Report to Congress	2,080	Plus $27,500 for printing &
mailing Report to Congress

3.   Review draft 305(b) reports	590	10 hours per submittal for 59
submittals

4.   Review final 305(b) reports	177	3 hours per submittal for 59
submittals

5.   Review annual electronic updates of State databases	800	Based on
recent experience

6.   Assist States with ADB indexing	3,328	4160 hours reduced by 20% to
take into account decreasing workload as more States complete indexing

7.   Maintain national ADB database	1,040	Based on recent experience

8.   Prepare 303(d) guidance	62	Based on recent experience

9.  Provide technical assistance to States for 303(d)	236	4 hours per
respondent per year for 59 respondents

10.  Review draft 303(d) lists	236	8 hours per respondent every 2 years
for 59 respondents

11.  Review final 303(d) lists and resolve disapprovals	500	Based on
recent experience

 B.4 Agency Burden Estimates for Enhanced Benefit Cost Analysis of Water
Quality Standards

	The Agency will develop guidance for the States that will assist them
in improving their benefit cost analyses, while minimizing the
additional burden of doing so. The Agency plans to target the guidance
so that can be applied by a mid-level analyst.

The guidance for performing benefits analysis will likely:

include a list of data elements required to conduct a benefits analysis,
and include suggested sources and techniques for each,

present the results of a meta-analysis of existing valuation studies,
with recommended values for different water body types, expected changes
in water quality, and categories of benefits,

discuss how and when to apply different values, will provide default
values where there is no basis or need to tailor the estimates to
location-specific characteristics, and will describe circumstances in
which it is important to develop location-specific estimates, and

include a user-friendly spreadsheet model that implements the proffered
analysis, and makes it easy to substitute use-selected values to tailor
the model to specific States and to conduct sensitivity analyses to
address key uncertainties.

	The guidance for preparing cost analysis will provide information
regarding cost, including data sources, default values and worksheets.

	The Agency anticipates that States will have the opportunity to
participate in the review of draft guidance materials to help ensure
that the guidance and the tools it provides are useful and practical
from the States’ perspective. If appropriate, the Agency may provide
additional training materials and/or workshops to further assist States
in using the guidance.

	The Agency estimates that the cost of providing this additional
guidance would be $327,885. Over the three year period of the ICR, the
annual cost would be $109,295 which translates into a burden of 2,117
hours annually (at the fully loaded hourly rate of $51.62 as discussed
in 6(c)).

B.5 Agency Burden Estimates for Reviewing TMDLs

	To estimate the Agency burden associated with reviewing TMDLs, we
assume that on average about 4,000 TMDLs per year will be submitted to
EPA over the three-year period of the ICR as a result of consent decrees
and state submitted schedules. We also assume that about half of these
TMDLs (2000) will be submitted in packages of about 10 or more
substantially similar TMDLs. Clusters of similar TMDLs can be reviewed
in an average of 1 hour, amounting to a total of 2,000 hours annually.
For non-clustered TMDLs, it is anticipated that a disapproval (perhaps
occurring 15% of the time for the remaining 2,000 TMDLs – i.e., 300
TMDLs) will require about 1 day (8 hours) of effort amounting to 2400
hours annually; and an approval (perhaps occurring 85% of the time for
the remaining 2000 TMDLs – i.e., 1,700 TMDLs) will require about ½
day (4 hours) of effort amounting to 6,800 hours annually.  Altogether,
the annual burden is estimated to be 11,200 hours.

     2 The combination of the 50 States, the District of Columbia, and 5
Territories (Puerto Rico, the Virgin Islands, Guam, American Samoa, and
the Northern Mariana Islands) are collectively referred to as “the
States” in this document.

     3 The Cadmus Group, Inc., State Water Quality Management Resource
Analysis: Interim Report on Results, prepared for the State Water
Quality Management Resource Analysis Task Force, December 2001.

     4 Consumer Price Index, Nov. 2002:181.5; Consumer Price Index,
August 2007: 207.9.  (207.9/181.5= 1.145).

October 3, 2007

October 3, 2007

  PAGE   2

October 3, 2007

  PAGE   10

October 3, 2007

  PAGE   21

  PAGE   24

  PAGE   28

A-  PAGE   3

B-  PAGE   5

C-  PAGE   1


[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80938-80940]
[FR Doc No: 2011-33156]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0954; FRL-9611-6]

Human Studies Review Board; Notification of a Public Meeting

AGENCY: U.S. Environmental Protection Agency.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The EPA Office of the Science Advisor announces a public
meeting of the Human Studies Review Board to advise the Agency on the
EPA scientific and ethical reviews of research with human subjects.

DATES: This public meeting will be held on January 26, 2012, from
approximately 9 a.m. to approximately 5:30 p.m. Eastern Time. Comments
may

be submitted on or before Thursday, January 19, 2012.

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2011-0954, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the online
instructions for submitting comments.
    Email<EMAIL_ADDRESS>    Mail: The EPA Docket Center EPA/DC, ORD Docket, Mail code: 28221T,
1200 Pennsylvania Avenue NW., Washington, DC 20460.
    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA
Headquarters Library, Room Number 3334 in the EPA West Building, at
1301 Constitution Avenue NW., Washington, DC 20460. The hours of
operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through
Friday, excluding federal holidays. Please call<PHONE_NUMBER> or email
the ORD Docket at<EMAIL_ADDRESS>for instructions. Updates to
Public Reading Room access are available on the Web site http://www.epa.gov/epahome/dockets.htm.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0954. The Agency's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information or other information the
disclosure of which is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to the EPA without
going through http://www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, the EPA recommends that you include your
name and other contact information in the body of your comment and with
any electronic storage media you submit. If the EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, the EPA may not be able to consider your comment.
Electronic files should avoid the use of special characters, any form
of encryption, and be free of any defects or viruses.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to
receive further information should contact Jim Downing at telephone
number<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>or Lu-Ann Kleibacker on telephone number (202) 564-
7189; fax<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
mailing address Environmental Protection Agency, Office of the Science
Advisor Mail code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC
20460. General information concerning the EPA HSRB can be found on the
EPA Web site at http://www.epa.gov/osa/hsrb/.

SUPPLEMENTARY INFORMATION:
    Location: The meeting will be held at the EPA Conference Center--
Lobby Level, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA 22202.
    Meeting access: Seating at the meeting will be on a first-come
basis. To request accommodation of a disability, please contact the
persons listed under FOR FURTHER INFORMATION CONTACT at least ten
business days prior to the meeting using the information under FOR
FURTHER INFORMATION CONTACT, so that appropriate arrangements can be
made.
    Procedures for providing public input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in Section
I, ``Public Meeting'' under subsection D. ``How May I Participate in
this Meeting?'' of this notice.

I. Public Meeting

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by the EPA,
or to persons who are, or may be required to conduct testing of
chemical substances under the Federal Food, Drug, and Cosmetic Act or
the Federal Insecticide, Fungicide, and Rodenticide Act. This notice
might also be of special interest to participants of studies involving
human subjects, or representatives of study participants or experts on
community engagement. Since many entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult Jim
Downing or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION
CONTACT.

B. How can I access electronic copies of this document and other
related information?

    In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, Public Reading Room. The EPA/DC Public Reading Room is located in
the EPA Headquarters Library, Room Number 3334 in the EPA West
Building, at 1301 Constitution Avenue NW., Washington, DC 20460. The
hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday
through Friday, excluding federal holidays. Please call<PHONE_NUMBER>
or email the ORD Docket at<EMAIL_ADDRESS>for instructions. Updates
to Public Reading Room access are available on the Web site (http://www.epa.gov/epahome/dockets.htm).
    The Agency's position paper(s), charge/questions to the HSRB, and
the meeting agenda will be available by the first week of January 2012.
In addition, the Agency may provide additional background documents as
the materials become available. You may obtain electronic copies of
these documents, and certain other related documents that might be
available electronically, from the regulations.gov Web site and the EPA
HSRB Web site at http://www.epa.gov/osa/hsrb/. For questions on
document availability, or if you do not have access to the Internet,
consult either Jim Downing or Lu-Ann Kleibacker listed under FOR
FURTHER INFORMATION CONTACT.

C. What should I consider as I prepare my comments for the EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.

    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data that you
used to support your views.
    4. Provide specific examples to illustrate your concerns and
suggest alternatives.
    5. To ensure proper receipt by the EPA, be sure to identify the
Docket ID number assigned to this action in the subject line on the
first page of your response. You may also provide the name, date, and
Federal Register citation.

D. How may I participate in this meeting?

    You may participate in this meeting by following the instructions
in this section. To ensure proper receipt by the EPA, it is imperative
that you identify Docket ID number EPA-HQ-ORD-2011-0954 in the subject
line on the first page of your request.
    1. Oral comments. Requests to present oral comments will be
accepted up to Thursday, January 19, 2012. To the extent that time
permits, interested persons who have not pre-registered may be
permitted by the Chair of the HSRB to present oral comments at the
meeting. Each individual or group wishing to make brief oral comments
to the HSRB is strongly advised to submit their request (preferably via
email) to Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER
INFORMATION CONTACT no later than noon, Eastern Time, Thursday, January
19, 2012, in order to be included on the meeting agenda and to provide
sufficient time for the HSRB Chair and HSRB Designated Federal Official
to review the meeting agenda to provide an appropriate public comment
period. The request should identify the name of the individual making
the presentation and the organization (if any) the individual will
represent. Oral comments before the HSRB are generally limited to five
minutes per individual or organization. Please note that this includes
all individuals appearing either as part of, or on behalf of, an
organization. While it is our intent to hear a full range of oral
comments on the science and ethics issues under discussion, it is not
our intent to permit organizations to expand the time limitations by
having numerous individuals sign up separately to speak on their
behalf. If additional time is available, further public comments may be
possible.
    2. Written comments. Submit your written comments prior to the
meeting. For the Board to have the best opportunity to review and
consider your comments as it deliberates on its report, you should
submit your comments at least five business days prior to the beginning
of this meeting. If you submit comments after this date, those comments
will be provided to the Board members, but you should recognize that
the HSRB members may not have adequate time to consider those comments
prior to making a decision. Thus, if you plan to submit written
comments, the agency strongly encourages you to submit such comments no
later than noon, Eastern Time, Thursday, January 19, 2012. You should
submit your comments using the instructions in Section I., under
subsection C., ``What Should I Consider as I Prepare My Comments for
the EPA?'' In addition, the agency also requests that persons
submitting comments directly to the docket also provide a copy of their
comments to Jim Downing or Lu-Ann Kleibacker listed under FOR FURTHER
INFORMATION CONTACT. There is no limit on the length of written
comments for consideration by the HSRB.

E. Background

    The HSRB is a Federal advisory committee operating in accordance
with the Federal Advisory Committee Act 5 U.S.C. App.2 Sec.  9. The
HSRB provides advice, information, and recommendations to the EPA on
issues related to scientific and ethical aspects of human subjects
research. The major objectives of the HSRB are to provide advice and
recommendations on: (1) Research proposals and protocols; (2) reports
of completed research with human subjects; and (3) how to strengthen
EPA's programs for protection of human subjects of research. The HSRB
reports to the EPA Administrator through the Agency's Science Advisor.
    1. Topics for discussion. At its meeting on January 26, 2012, the
EPA's Human Studies Review Board will consider scientific and ethical
issues surrounding these topics:
    a. A new scenario design and associated protocol from the
Agricultural Handler Exposure Task Force describing proposed research
to measure dermal and inhalation exposure to workers who mix, load, and
apply liquid pesticides with powered handgun equipment. The Agency
requests the advice of the HSRB concerning whether, if it is revised as
suggested in the EPA's review and if it is performed as described, this
research is likely to generate scientifically reliable data, useful for
assessing the exposure of those who mix, load, and apply liquid
pesticides with powered handgun equipment, and to meet the applicable
requirements of 40 CFR part 26, subparts K and L.
    b. The report of a completed scenario monograph and study report
from the Antimicrobial Exposure Assessment Task Force II in which the
dermal and inhalation exposure of professional janitorial workers was
monitored as they applied a liquid antimicrobial pesticide product for
indoor surface disinfecting using a pressurized aerosol can. The EPA
seeks the advice of the HSRB on the scientific soundness of this
completed research and on its appropriateness for use in estimating the
exposure of professional janitorial workers who apply liquid
antimicrobial pesticide products to indoor surfaces using pressurized
aerosol cans, and on whether available information supports a
determination that the study was conducted in substantial compliance
with subparts K and L of 40 CFR part 26.
    2. Meeting minutes and reports. Minutes of the meeting, summarizing
the matters discussed and recommendations, if any, made by the advisory
committee regarding such matters, will be released within 90 calendar
days of the meeting. Such minutes will be available at http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition,
information regarding the Board's final meeting report, will be found
at http://www.epa.gov/osa/hsrb/ or from the person listed under FOR
FURTHER INFORMATION CONTACT.

    Dated: December 19, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-33156 Filed 12-23-11; 8:45 am]
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