NOTE:  This draft supporting statement for the First Federal Register
Notice (December 2008) uses the estimates for the current approved
Information Collection (EPA ICR Number 0138.08).  EPA will revise the
estimates prior to OMB submission with the Second Federal Register
Notice. The public will have a second opportunity to comment at that
time.

THE INFORMATION COLLECTION REQUEST (ICR)

SUPPORTING STATEMENT

FOR THE 301(h) PROGRAM

Modification of Secondary Treatment Requirements for Discharges Into
Marine Waters, EPA ICR Number 0138.0809, OMB Control Number 2040-0088

April 2005December 2008

A.	JUSTIFICATION

1.	Need for Information Collection

As described below in more detail, the 301(h) program involves
collecting information from two sources: 1) the municipal wastewater
treatment facility, commonly called a publicly owned treatment works
(POTW) and 2) the State in which the POTW is located.  The POTW seeking
to obtain a 301(h) waiver provides application, monitoring, and toxic
control program information.  The State provides State determination and
State certification information.  The statutory and regulatory
authorities for these two aspects of the section 301(h) program are
discussed in the following sections.

Statutory Authority

The Clean Water Act (CWA) requires that POTWs achieve compliance with
uniform technology-based standards of secondary treatment.  These
standards describe the minimum level of effluent quality attainable by
secondary treatment.  Section 301(h) of the CWA provides that POTWs that
discharge into certain marine waters specified in the section may apply
for and obtain a waiver from secondary treatment requirements for
conventional pollutants (Biochemical oxygen demand(BOD, Suspended
solids(SS, pH(a measure of acidity or alkalinity) if particular
regulatory criteria are met.  According to this section, such a waiver
must be issued by the Administrator of the U.S. Environmental Protection
Agency (EPA) with the concurrence of the State.  The section also
established an application deadline of December 31, 1982, for eligible
POTWs choosing to apply.  The POTW receiving a 301(h) waiver benefits
since it reduces costs of construction as well as operation and
maintenance.  The Ocean Pollution Reduction Act of 1994 provided an
opportunity for one additional POTW to reapply for a 301(h) waiver by
April 1995.

Section 301(h) lists nine criteria that an applicant must satisfy to
ensure that any proposed less-than-secondary discharge does not
adversely affect the marine receiving water(s ecosystem or beneficial
uses.  To obtain a section 301(h) waiver, a POTW must demonstrate that
it meets the following criteria:

1)	An applicable water quality standard exists for the pollutant for
which the modification is requested.

2)	The modified discharge, alone or in combination with pollutants from
other sources, will not interfere with attaining or maintaining water
quality that protects water supplies, biota, and recreational uses.

3)	The POTW has a monitoring program to measure the discharge(s effects
on the receiving waters and biota.

4)	The modified discharge will not result in additional requirements on
any other point or nonpoint sources.

5)	All pretreatment requirements will be enforced.

6)	Special requirements for pollutants for which no pretreatment
standards exist will be met.

7)	A program to eliminate the entrance of toxic pollutants from
nonindustrial sources will be established.

8)	There will be no new or increased discharges during the term of the
permit.

9)	The discharge has received at least primary or equivalent treatment
and meets water quality criteria established under section 304(a)(1) of
the CWA.

Once a 301(h) permit is issued, the POTW must monitor the effects of its
discharge and establish both a monitoring program and a toxics control
program for nonindustrial and industrial sources as specified in Numbers
3, 5, 6, and 7 above.

Numbers 6 and 9 of the above criteria were added to the original
provisions of section 301(h).  They correspond to sections 303(c) and
(d), respectively, of the Water Quality Act (WQA) and amend section
301(h) of the CWA.  The WQA (Public Law 100-4) was passed February 4,
1987.  WQA section 303(c) requires each 301(h) waiver applicant serving
a population of over 50,000 to make two demonstrations: 1) to
demonstrate that, with respect to any toxic pollutant introduced from an
industrial source for which there is an applicable pretreatment
requirement in effect, sources introducing waste into the POTW are in
compliance with all applicable pretreatment requirements; and 2) to
demonstrate that the POTW has in effect a pretreatment program which, in
combination with the  treatment processes, removes the same amount of
such pollutant as if the POTW has secondary treatment and no
pretreatment program exists for such pollutant.  Section 303(d) of the
WQA states that, at the time the waiver becomes effective, 301(h) waiver
applicants must be discharging effluent that has received at
least-primary or equivalent treatment and meets water quality criteria
after initial mixing.

The State in which the discharge originates is responsible for
determining compliance with two of the nine criteria listed above(Number
1, which states that an applicable water quality standard must exist,
and Number 4, which states that the discharge must not result in
additional requirements for any other point or nonpoint sources.  The
State is the best entity to evaluate these criteria because compliance
with state law and impacts on other State sources are matters of State
responsibility.  In addition, section 301(h) provides that EPA may not
approve a 301(h) modification if the State does not concur with the
modification.

Another section of the CWA also relates to State activities.  Section
401(a)(1) of the Act requires that States certify that all EPA-issued
permits meet all State laws, including State water quality standards. 
This certification is relevant to 301(h) modified permits because the
authority to make 301(h) decisions has not been delegated to the states.
 Every permit with 301(h) modification is issued either by EPA alone or
jointly by the State and EPA, in the case of States delegated authority
to implement the National Pollutant Discharge Elimination System (NPDES)
program.  If the State does not concur with a 301(h) waiver, or if the
State denies certification under section 401 of the CWA, EPA may not
issue a permit.  Concurrence with a 301(h) decision takes the form of
the 401(a)(1) certification.  Combining these two requirements ensures
that any effort expended in concurring with a 301(h) requirement will
not be repeated in preparing a 401(a)(1) certification.

Regulatory Authority

Regulations implementing section 301(h) of the CWA were originally
promulgated by EPA on June 15, 1979, and revised on June 8, 1982, and
November 26, 1982.  Revisions to these 1982 regulations were published
on August 9, 1994, to respond to changes required by the WQA.  This
supporting statement incorporates the requirements of these revisions to
the 301(h) regulations.

The 301(h) regulations, 40 CFR Part 125, Subpart G, incorporate the nine
301(h) criteria listed previously and specify the way in which a POTW
that wants to obtain a variance from secondary treatment requirements
can demonstrate that its less-than-secondary discharge complies with
these criteria.  The regulations establish requirements for
applications, for monitoring and toxics control programs, and for State
determinations of compliance with the two criteria of the CWA discussed
in the previous section.  The regulations mandating collection of State
certification information are contained in 40 CFR 124.53 and 124.54.

Program Status and Information Needs

As indicated above, the application deadline for 301(h) waivers has
passed; EPA received 208 applications by the 1982 deadline.  The
application received pursuant to the Ocean Pollution Reduction Act of
1994 is for a POTW that previously withdrew from the 301(h) program. 
Table 1 lists the POTWs that currently have waivers or have decisions
pending.



	TABLE 1.  STATUS OF POTWs AS OF AUGUST 2005

Current 301(h) Waiver Recipients



Name	

State	





EPA REGION I

Bayville Village

Boothbay Harbor

Bucksport

Eastport

Eastport/Quoddy

Jonesport

Lubec

Milbridge

Newton Highlands (Squirrel Is)

North Haven

Northport Village (Belfast)

Searsport

Winterport

Gloucester

Gosnold

Portsmouth

EPA REGION II

Aguadilla

Arecibo

Bayamon/Puerto Nuevo

Carolina

EPA REGION IX

Tafuna (Pago Pago)

Utulei

Goleta

Morro Bay

San Diego (Pt. Loma)*

Honouliuli (Honolulu)

Sand Island (Honolulu)

Agana

Agat

Northern District (Dededo)

EPA REGION X

Anchorage

Haines

Ketchikan

Pelican

Petersburg

Sitka

Skagway

Whittier

Wrangell	

ME

ME

ME

ME

ME

ME

ME

ME

ME

ME

ME

ME

ME

MA

MA

NH

PR

PR

PR

PR

AS

AS

CA

CA

CA

HI

HI

GU

GU

GU

AK

AK

AK

AK

AK

AK

AK

AK

AK	

 

 



Total = 39

*San Diego reapplied for a 301(h) waiver in April 1995, pursuant to
Ocean Pollution Reduction Act of 1994.  San Diego (Pt. Loma) was in the
original universe of 208 applicants for a 301(h) waiver, and withdrew
its application.  It is listed here to reflect its current status.

	

	TABLE 1 (continued)

301(h) Applications Pending Final Decision



Name	

State	





EPA REGION I

Stonington

EPA REGION II

Ponce

	

ME

PR

	





	

	



Total = 2

At this time in the 301(h) program evolution, EPA has obtained most of
the information it needs from POTWs to make decisions on waiver
applications.  However, application information from POTWs is still
needed in two situations: 1) when that POTW elects to submit a revised
application and 2) when a 301(h) permit is nearing its expiration date
and the permittee desires to renew its permit.  EPA also needs two types
of information from the States for these revised and renewed 301(h)
permit applications: 1) determinations on whether a proposed 301(h)
discharge meets State water quality standards and whether the discharge
will result in additional treatment requirements for another point
source and 2) a 401(a)(1) certification before EPA can issue a draft
modified NPDES permit under the 301(h) program.

Based on the status of the program and the associated statutory and
regulatory requirements, EPA needs six types of information to conduct
the 301(h) program during the 3-year term of the Information Collection
Request (ICR): 1) application revision information; 2) permit reissuance
information; 3) monitoring program information; 4) toxics control
program information; 5) State determination information; and 6) State
certification information.  Table 2 summarizes information needs of the
301(h) program and the regulatory requirements that mandate the
collection of this information.



TABLE 2.  INFORMATION COLLECTION ACTIVITIES FOR THE 301(h) PROGRAM

	Activity	

	Regulatory Authority



Application Revision	

40 CFR 125.59(d), (f) and (g)



Permit Reissuance	

40 CFR 125.59 (c), (f) and (g)



Monitoring Program	

40 CFR 125.68(c) and (d)

40 CFR 125.63(b), (c), and (d)



Toxics Control Program	

40 CFR 125.66



State Determination	

40 CFR 125.61(b)(2) and 125.64(b)



State Certification	

40 CFR 124.53 and 124.54



	





The status of the 301(h) program drives the relative emphases on types
and amounts of information needed by the EPA from the POTWs and States. 
Much of the information EPA needs at this time is ongoing information
about the monitoring and toxics control programs from all 301(h)
permittees.  The Agency(s need for application revision information will
be reduced as decisions are made on the pending and tentative decision
applications, while the need for updated information for permit renewals
will continue to have importance as the 301(h) permits reach their
expiration dates.

EPA(s need for the six types of information is explained in more detail
below.

Application Revision Information

Section 125.59(d) of 40 CFR allows a POTW to revise its application one
time only, following a tentative decision by EPA to deny the waiver
request.  In its application revision, the POTW usually corrects
deficiencies and changes proposed treatment levels as well as outfall
and diffuser locations.  The application revision is a voluntary
submission for the applicant.  In addition, 40 CFR Section 125.59(g)
allows applicants that are authorized or requested to submit additional
information to submit a revised application where the information
supports changes in proposed treatment levels and/or outfall location
and diffuser design.  EPA needs this information to evaluate revised
applications and to determine whether the modified discharge will ensure
receiving water quality, biological habitats, and beneficial uses of the
receiving waters.

Permit Reissuance Information

When permits with 301(h) waivers reach their expiration dates, EPA must
have updated information on the discharge to determine whether the
301(h) criteria are still being met and whether the 301(h) variance
should be reissued.  Under 40 CFR 125.59(f), each 301(h) permittee is
required to submit an application for a new section 301(h) modified
permit within 180 days of the existing permit(s expiration date; 40 CFR
Part 125.59(c) lists the information required for a modified permit. 
The information that EPA needs to determine whether the POTW(s
reapplication meets the section 301(h) criteria previously listed is
outlined in the questionnaire attached to 40 CFR Part 125, Subpart G. 
The questionnaire is similar to the two used by POTWs for their original
applications.

The revisions to 40 CFR Part 125 covered by this supporting statement
include revisions to the two questionnaires.  The main change is that
originally two questionnaires were used(one for small POTWs
(contributing population less than 50,000 people and average dry weather
flows less than 5 million gallons per day [mgd]) and the other
questionnaire for large POTWs (contributing populations more than 50,000
people and average dry weather flows greater than 5 mgd). The current
regulations now contain one questionnaire.  The breakdown of information
required of small and large POTWs is the same in the merged
questionnaire as in the previous separate questionnaire for small and
large POTWs.  Although the two questionnaires have been merged, small
POTWs are not required to submit all the information required of large
POTWs.

Monitoring and Toxics Control Program Information

Once a waiver has been granted, EPA must continue to assess whether the
discharge is meeting the criteria listed on pages 2 and 3 and that the
receiving water quality, biological habitats, and beneficial uses are
protected.  To do this, EPA needs monitoring information furnished by
the permittee.  According to 40 CFR 125.68(d), any permit issued with a
301(h) variance must contain the monitoring requirements of 40 CFR
125.63(b), (c), and (d) for biomonitoring, water quality criteria and
standards monitoring, and effluent monitoring, respectively.  Section
125.68(d) also requires reporting at the frequency specified in the
monitoring program.  In addition to monitoring information, EPA needs
information on the toxics control program to ensure that the permittee
is minimizing industrial and nonindustrial toxic pollutant and pesticide
discharges into the treatment works (40 CFR 125.66).

State Determination Information

For revised or renewed 301(h) permit applications, EPA also needs a
State determination.  The State determines whether all State laws
(including water quality standards) are met to ensure that receiving
water quality, biological habitats, and beneficial uses of the receiving
waters are protected.  Additionally, the State must determine if the
applicant(s discharge will result in additional treatment, pollution
control, or any other requirement for any other point or nonpoint
sources.  This process allows the State(s views to be taken into account
when EPA reviews the 301(h) application and develops permit conditions. 
As mentioned previously, the State is the best source for this
information because it is aware of State laws and on combined effects of
discharges in the State.

State Certification Information

For revised and renewed 301(h) permit applications, EPA also needs the
401(a)(1) information to ensure that all State laws are met by any
permit it issues with a 301(h) modification and that the State accepts
all the permit conditions.  This information is the vehicle by which the
State can exercise its authority to concur with or deny a 301(h)
decision made by the EPA Regional Office.

2.  Description and Practical Utility of the Information Collection
Activity

EPA Headquarters and the EPA Regional Offices use the information
collected under this information collection request to conduct various
activities in the 301(h) program.  The six collection activities covered
by this ICR are listed in Table 3 along with a description of the
respondents and the frequency of the collection.  The following
describes each of the six information collection activities and
highlights:

Respondents;

Processes and techniques used to obtain the information;

How and by whom the information is used; and

Flow of the information(where it is submitted, filed, etc.

Permit Reissuance Information

The first two types of information collection covered by this ICR are
used in the application process.  Permit reissuance information is
submitted by 301(h) permittees nearing the expiration date of their
permits.  The permittee must submit an application for a renewed section
301(h) permit 180 days prior to the expiration of its existing permit. 
Each POTW must submit a new application questionnaire (which may
reference previous submittals to the extent they are relevant and not
out of date), along with any other NPDES permit application information
required by the Region.  The data requested by the questionnaire consist
of general information on the treatment system, the effluent, the
receiving water characteristics, the biological conditions in the
receiving waters, and the State and Federal laws that affect the
discharge.  The questionnaire also provides a framework to assess the
effects of the discharge and requests appropriate data for these
analyses.  In addition, data are requested on physical characteristics
of the discharge, compliance with applicable water quality standards,
existence of pretreatment standards or secondary or equivalent levels of
treatment for toxic pollutants from industrial sources, impact on public
water supplies, biological impact of the discharge, effects on other
point and nonpoint sources, and the proposed monitoring and toxics
control programs.

	TABLE 3.  301(h) PROGRAM INFORMATION COLLECTION ACTIVITIES, RESPONDENT
DESCRIPTIONS, AND FREQUENCY

	Activity	

	Respondents	

	Frequency



Permit Reissuance	

Any 301(h) permittee nearing expiration date of permit.	

Once every 5 years beginning with permit issuance.



Application Revision	

Original 301(h) waiver applicants that have not yet received a final
decision.	

One time.



Monitoring Program	

All 301(h) permittees.	

Varies case-by-case as individual permit specifies.



Toxics Control Program	

All 301(h) permittees.	

Varies case-by-case.



State Determination	

States in which POTWs with draft 301(h) permits are located.	

Once every 5 years beginning with permit issuance. 



State Certification	

States in which POTWs with draft 301(h) permits are located.	

Same as above regarding permit reissuance.



Many of the required data are available to the POTW from the studies and
monitoring performed during the life of the permit, from implementation
of toxics control and pretreatment programs, and from initial studies
performed for the original waiver application.  To obtain reapplication
information, the POTW can review existing data on monitoring, treatment
plant operation, and pretreatment and toxics control, and, if necessary,
conduct new studies of the receiving waters, the discharge, and the
impacts of the discharge on receiving waters.

EPA uses the information to determine whether the criteria of section
301(h) (as amended by WQA Section 303) are being met and whether the
receiving water quality, biological habitats, and beneficial uses will
be protected.  For the initial waiver applications, EPA conducted very
involved technical evaluations.  The Agency expects that similar but
reduced effort will be required to evaluate the permit reissuance
information.  Once EPA makes a decision regarding the reapplication for
a waiver, it uses the data provided by the POTW to develop permit
conditions and specify the monitoring program that will be incorporated
in the NPDES permit.  EPA specifies the parameters to be measured,
techniques to be used, and frequency of

monitoring.  In addition, EPA uses the data to make recommendations for
the toxics control and pretreatment programs.

Permit reissuance information is submitted to the appropriate EPA
Regional Offices, where it is evaluated.  These data are then filed at
the Regional Office and can be retrieved as required.

Application Revision Information

The second type of information used in the application process is the
application revision information.  These data are submitted once by any
original applicant for a 301(h) waiver that has received a tentative
decision when the applicant desires to revise its original application. 
Revisions of the proposed treatment levels and/or outfall and diffuser
location and design, and data to correct any deficiencies can be
included in the revised application.  This one-time-opportunity is
generally used by POTWs that have received tentative denials of the
301(h) waiver.  Two POTWs currently have applications with pending
waiver decisions.  Applicants authorized or asked to submit additional
information under 40 CFR 125.59(g) may also submit a revised application
where that information supports changes in proposed treatment levels
and/or outfall location and diffuser design.

As with the first type of information, these data are used by the EPA
Regional Office to determine whether the revised proposed discharge
meets the criteria specified under section 301(h).  If the criteria are
met, EPA may issue a decision to approve the waiver.  The application
revision information is also used to make decisions on the monitoring
and toxics programs requirements and is then filed and retained by the
EPA Regional Office.

Monitoring and Toxics Control Program Information

The next two information collection elements(monitoring and toxics
control program data(are used by EPA in the ongoing administration of
the 301(h) program.  The type and frequency of information submitted
varies among the POTWs, depending on their particular circumstances. 
POTWs may be required to conduct biological, water quality, and effluent
monitoring.  Certain small POTWs may be required to conduct only
periodic surveys of the biological communities most likely to be
affected by the discharge and may not need to provide the
bioaccumulation, sediment sampling, and fisheries data required of
larger POTWs.  Monitoring data are used by the EPA Region to evaluate
the continuing impact of the modified discharge on the marine biota, to
evaluate continuing compliance with applicable water quality standards
and/or criteria, to measure the toxic substances and pesticides in the
effluent, and to assess compliance with permit requirements.  These data
are also used to evaluate the continued effectiveness of the toxics
control program.

All monitoring data are submitted by the POTW to the EPA Regional
Office.  These data are stored in the Ocean Data Evaluation System
(ODES), described in section 3, and can be easily retrieved, or stored
in the new STORET Office of Water Storage and Retrieval System or an
equivalent database, and analyzed, as determined by the EPA Regional
Office.

The toxics control program information includes any information EPA can
use to determine whether the POTW is implementing effective industrial
and nonindustrial toxics control programs.  POTWs must develop a public
education program for nonindustrial source control and submit this
program to EPA within 18 months of the modification approval. 
Additional and continued information associated with this program may
also be required.

State Determination Information

The final two types of information collection covered by this ICR, State
determinations and State certifications, are collected and submitted by
States, not POTWs as in the first four activities.  The State
determination is used in the application process.  Applicants for 301(h)
waivers must submit with their application revision or reapplication two
determinations signed by the appropriate State or interstate agency of
the State where the discharge originates: 1) a determination that the
modified discharge will comply with State law including water quality
standards and 2) a determination indicating whether the applicant(s
discharge will result in additional treatment, pollution control, or
other requirements for any other point or nonpoint sources.  Both
determinations must outline the reasons for the conclusions reached in
the State determination.  Therefore, the respondents of this information
collection are the States in which a proposed 301(h) discharge
originates.

The appropriate State agency or department has the background
information available to make these determinations.  For the first
determination, the State needs to identify and interpret the applicable
State requirements and then evaluate the application data as they relate
to these standards, using applicable analytical techniques.  For the
second determination, the State must review information contained in
State files or databases and employ appropriate technical evaluations to
determine the effects of the proposed discharge on other sources.

The State submits this determination information to the applicant,
which, in turn, submits the information to the Regional Administrator. 
The information is reviewed and filed at the Region along with other
301(h) application information.  The State determinations must be
received by the EPA Regional Office no later than 90 days after the
application, reapplication, or application revision is submitted to EPA.
 EPA will not begin review of a 301(h) application revision unless it
has received favorable determinations from the State.  If the State
submits an unfavorable determination, the State is deemed not to concur
with the proposed variance.  Consequently, if the State provides an
unfavorable determination, EPA must deny the application without further
review.  If the determination is favorable, EPA uses the information to
assess the State(s position on these issues and to incorporate the
State(s views when deciding on both a variance application and a draft
permit.  In addition, EPA uses this information to explain the State(s
reasoning to any applicants that challenge the State(s position.

State Certification Information

The last type of information under this ICR, the 401(a) certification,
is used after the 301(h) application process is complete, during the
permit issuance process.  Certification information is submitted only if
EPA tentatively approves the 301(h) waiver application and has prepared
a draft permit incorporating a 301(h) waiver.  The certification is
required for both the original draft permit with a 301(h) variance and
each subsequent, or reissued, permit containing such a variance.  When
an EPA Regional Administrator issues a tentative approval on a 301(h)
variance, he or she forwards the decision to the State and specifies a
reasonable time (not more than 60 days) for the State to submit the
certification.  If the State does not submit the certification by this
time, the State is deemed to have concurred with the variance.

The State certification must contain the following information:

Any additional or more stringent conditions than the draft permit
necessary to ensure compliance with applicable CWA sections 208(e), 301,
302, 303, 306, and 307 and with appropriate requirements of State law. 
If the State finds that more stringent conditions are necessary, it must
cite the CWA or State law references on which the condition is based.

  A statement of the extent to which each condition of the draft permit
can be made less stringent without violating the requirements of State
law, including water quality standards.

The State must review the appropriate State laws and CWA sections in
reference to the particular conditions in the draft permit.  To obtain
the information for the certification, the State uses the information it
derived from preparing its determination of compliance with State laws
and water quality standards.  It uses appropriate technical evaluations
to obtain the other information required for the certification.  The
background data that the State needs to prepare the certification should
be available in State files, and the State should be familiar with the
analytical techniques it must use.  In addition, the State has available
all background information and calculations that EPA used to make the
301(h) waiver decision and to establish permit conditions.  This
information is particularly useful to the State in reviewing very
complex permits and in assessing aspects of the draft permit and the
301(h) modification for which it does not have extensive experience.  In
these situations, the State has the benefit of EPA(s expertise and
technical evaluation.

The EPA Regional Office uses the information contained in the State
certification to ensure that the State concurs with any 301(h)
modifications it has approved and to ensure that the conditions in the
draft and final permits meet, and will continue to meet, all State laws
and water quality standards.  The certification is also used by EPA to
ensure a State is fully aware of all permit conditions imposed on a
discharger in that State and that all permit conditions are workable for
the State.  In addition, EPA uses the information to make any necessary
revisions to the draft permit before issuing a final permit.

The 401(a)(1) certification is submitted to the EPA Regional Office
within the time specified by EPA.  The information is used by EPA in
developing the final permit and is filed at the Regional Office with all
the permit application data for that POTW.

3.	Use of Improved Information Technology to Minimize Burden

EPA has developed a user-friendly computer system for the 301(h)
program, the Ocean Data Evaluation System (ODES).  It has been used by
both POTWs and EPA to store and analyze marine environmental data.  EPA
has recently developed a new user-friendly STORET (STOrage and
RETrieval) system for water quality data. STORET is the standard data
storage system within EPA(s Office of Water.  The new STORET system
provides access for POTWs to submit data directly to the STORET system. 
Regional Offices have developed equivalent databases. A POTW can use
ODES to prepare information that EPA requires for the 301(h) program
such as impact assessment and evaluation, monitoring program designs,
and statistical analysis and modeling of marine and estuarine data.  EPA
can use ODES to store data, primarily monitoring data, provided under
the 301(h) program by POTWs; for national environmental assessments,
impact assessments, and evaluations; and for permit compliance
determinations.  There are other statistical analytical packages
available that can be used for data analysis as determined by the EPA
Regional Office.  Improvements in monitoring technology also afford
advantages to acquire measurements of important environmental parameters
electronically.  These data are more easily collected, managed and can
be imported with fewer errors, and with less time and effort for
storage, retrieval, analysis and reporting.

The State determinations and State certifications, however, must be made
on a case-by-case basis.  No particular format for the response is
required, and the response does not involve repetitive reporting or
frequent updating.

4.	Nonduplication

Section 301(h) requires a case-by-case demonstration of compliance with
criteria in that section, thereby minimizing the potential for
duplication of information collection.  EPA has taken additional
precautions.  As described below, the regulations are designed so that
applicants can use available information to the maximum extent.  Also,
EPA is coordinating information requests among related programs.  For
example, the Ocean Discharge Criteria, 40 CFR Part 125, Subpart M,
promulgated under the authority of CWA section 403(c), presume that
section 301(h) permittees comply with the criteria for ocean dischargers
(i.e., do not cause unreasonable degradation to the marine environment)
for those pollutants to which the waiver applies.  In addition, section
301(h) applicants who are also grantees in EPA(s construction grants
program provide information under the construction program regulations
(40 CFR Part 35), rather than under the Section 301(h) regulations.

In terms of the State(s Nonduplication effort, determination
information is requested from the State because it is the best and only
source of such information.  This type of information is not requested
by other Federal agencies or EPA offices because it relates specifically
to the 301(h) program.  The office preparing the ICR, the Office of
Wetlands, Oceans and Watersheds (OWOW), is the only EPA office involved
in the 301(h) program.

5.	Consideration of Alternatives

The criteria and legislative history of section 301(h) clearly indicate
that variance applications must be based on site-specific information
regarding the treatment system discharge characteristics, receiving
water quality and biological habitats, beneficial uses, oceanographic
characteristics, pretreatment program and standards, and impacts of the
modified discharges on water quality, biota, and beneficial uses.  EPA
has considered carefully the possible availability of information
collected for other purposes (e.g., water quality management planning,
permitting, pretreatment enforcement and research).  However, none of
these other sources, individually, is sufficient to enable EPA to
determine compliance with section 301(h) criteria for permit reissuance
applications, and revised applications.  Collectively, these sources may
be sufficient for many POTWs preparing reapplications when organized in
response to the application questionnaire.  In fact, EPA believes most
small applicants are able to complete the application questionnaire
using information from a variety of existing sources.  Still, it is
expected that some small applicants and most large applicants will need
to collect more data to demonstrate compliance with certain statutory
criteria for reapplications, and revised applications.

In such cases, the regulations encourage applicants to submit plans of
study to EPA for consultation before collecting additional field data. 
This kind of structured communication ensures that available information
is used to the maximum relevant extent and additional data needs, if
any, are provided in a cost-effective and timely way.  The project plan
approach is intended to ensure that an applicant’s(s limited time and
resources will be used only for additional data collection that is
essential for making a decision on its application revision and permit
reissuance applications.

The State(s decision must be made on a case-by-case basis in order to
consider the particular circumstances of each 301(h) application and
draft permit.  The State is the best and only source for the
determinations because it is most familiar with the information and is
most likely to have the information available to submit to EPA.

6.	Minimizing the Burden for Small Applicants

The section 301(h) regulations and application questionnaire (40 CFR
Part 125, Subpart G) are designed to simplify application requirements
for all applicants and to reduce the cost burden for small applicants. 
Small applicants are defined in the regulations as municipalities having
POTW service populations of less than 50,000 or discharge design flows
of less than 5 mgd.  EPA(s evaluation of applications showed that most
small applicants are able to complete the application questionnaire
using available information on their wastewater treatment system,
outfall configuration, discharge characteristics, receiving water
quality, biological habitats, oceanographic characteristics, and
beneficial uses.  Hence, for most small applicants, the cost of permit
reissuance application and application revision is minimized.  Also,
small applicants have the flexibility to design ongoing biological,
water quality, and discharge monitoring programs that are cost-effective
for their individual circumstances.  Finally, small applicants do not
have the burden of substantial elements of the requirements for
development and implementation of toxics control programs if they
certify that there are no known or suspected sources of toxics or
associated water quality or biological problems.  Therefore, EPA
believes that the costs to small section 301(h) applicants and small
section 301(h) permittees are minimized by the regulations and
questionnaire while compliance with section 301(h) criteria is ensured.

7.	Consideration of Less Frequent Collection

Application revision information is submitted once and is submitted only
if the POTW elects to revise its original application.  Reapplication
information is submitted every 5 years as the permit expires. 
Similarly, the State determination information and State certification
information is submitted one time for each revised or renewed permit
application, and draft permit.  Therefore, frequency of collection is
not an issue for these four categories of information collection.

The frequency of collection for monitoring and toxics program
information is determined on a case-by-case basis.  The information is
collected as frequently as is necessary to conduct the 301(h) program;
frequency can be minimized because the requirement is developed for each
respondent based on its particular circumstances.

8.	General Requirements

This ICR meets the requirements contained in 5 CFR 1320.5(d)(2).

9.	Consultations

Lines of communication with the respondents are kept open, and
respondents have numerous opportunities to comment to EPA, States, or
EPA(s contractor(s) concerning the information collection activities of
the 301(h) program.  EPA generally has a contractor prepare the
Technical Review Reports for 301(h) applications.

In addition, comments were formally requested in the Federal Register
(56 FR 2814, January 24, 1991) on the proposed revised 301(h)
regulations that included the information collection requirements
covered by a previous ICR, and again upon publication of the revised
regulations on August 9, 1994 (59 FR 40642), covered in the February
1996 ICR.  No comments were received.

In addition, as part of the process to prepare and submit the previous
and this current information collection request to OMB, EPA solicited
comments on the information request, required by 5 CFR 1320.8(d) (63 FR
71112, December 23, 1998; 67 FR 71245 January 3, 2002; and 70 FR 35082
June 16, 2005).  EPA received no comments.

10.  Confidentiality

The information covered by this ICR involves treatment plant operating
data, effects of POTWs( discharges on marine environments, and States(
viewpoints on issues concerning effects of POTWs( discharges on marine
environments.  None of this information is confidential; thus
confidentiality is not an issue.

11.  Sensitive Questions

No information of a sensitive nature is requested by this ICR.

12.  Cost to the Government and to the Respondents

The review costs to the Federal government and preparation costs to the
respondents (both POTWs and States) for the six information collection
activities covered under this ICR are summarized in Tables A-1 and A-2
of the appendix.  For respondents, the labor hour burden used in these
cost estimates is derived under the next item, Section 13.  For the
Federal government burden hour estimates used in computing the estimated
costs in Table A-1 are summarized in Table A-3 of the appendix.  These
burden hour estimates for the Federal government address decisions on
applications, review of State determinations and State certifications,
and evaluating the adequacy of permittee monitoring and toxics control
programs.

13.  Estimation of Respondent Burden

This section describes how the burden to respondents of the six 301(h)
information collection activities is estimated.  The burden is divided
into two categories: 1) POTW respondent burden and 2) State respondent
burden.  For the six information collection activities, the burden
estimate is dependent upon the size of the POTW applying for a section
301(h) variance.  Small POTWs, defined by EPA as those with flows of
less than 5 mgd and/or those that serve a population of less than 50,000
people, have reduced burdens in responding to each information
requirement. Correspondingly, it is less burdensome for States to make
determinations and certifications for these small POTWs than for large
POTWs with flows greater than 5 mgd and serving populations larger than
50,000 people.  The burden to POTWs is also not evenly distributed over
the years covered by this ICR because of changes in the program status
and associated information needs.

Annual, total, and average burdens and number of respondents for each
of the six information activities are compiled on Table A-4 of the
appendix.  Individual tables for each of the six information collection
activities are summarized on Tables A-6, A-7, A-8, A-10 and A-11 of the
appendix.  POTW respondents to these activities must complete five
general tasks:

1)	Read instructions supplied by EPA and contained in the regulations.

2)	Plan activities(determine what data are required and what must be
done to obtain the data.

3)	Create information using field surveys and other techniques.

4)	Gather information through literature searches, interviews, and
analyses of field survey and monitoring data.

5)	Complete permit reissuance application and transmit to EPA.

The effort required to complete these activities for permit
reapplication and application revision is estimated in Table A-5 of the
appendix.  The estimates in this table are based on EPA(s experience in
evaluating numerous original applications and application revisions.  It
is assumed that preparation of reapplications will require less effort
than preparation of original applications.  In addition, in breaking
down the estimates of effort for small and large applicants, it is
assumed that little or no field work is performed by small POTWs and
that a field study is conducted by each large POTW.

For application revision and reapplication, the number of respondents
and total burden hours for the 3 years covered by this ICR are presented
in Tables A-6 and A-7 of the appendix, respectively.  The number of POTW
respondents for each year varies depending on the program status and the
associated information needs, such as how many 301(h) permits are
nearing their expiration dates.  These numbers are projected by EPA
based on applicable program data and program experience.

The burden estimates for the monitoring program and for the toxics
control program are presented in Table A-8 of the appendix.  The
monitoring program effort estimates are for typical small and large
permittees and include the design and execution of necessary field
studies plus analyses and report writing.  EPA has estimated the burden
based on experience plus estimates from consulting firms contacted for
this purpose.  The toxics control program estimates are also for typical
small and large permittees and include estimates for developing and
implementing nonindustrial source control programs.

The burdens for State determinations and State certifications
activities are summarized in Tables A-9, A-10, and A-11 of the appendix.
 Respondents to these activities must complete four general tasks: 1)
identify applicable State requirements; 2) analyze material; 3) review
accuracy; and 4) report information.  For example, in deciding whether
the discharge will comply with State law, the State needs to identify
and interpret applicable State requirements.  The State would then
review the application data, which contain information on effluent and
ambient water quality characteristics, in order to consider the validity
of the data and select appropriate data points and conditions under
which compliance will be determined.  In addition, the State may wish to
review information contained in State files in order to check or verify
the applicant(s data.  Following this, the State would select the
technical evaluations it wishes to employ and apply them to the data
selected.  Finally, the State would check the accuracy of its approach
and calculations, and submit its determinations.

EPA realizes that the State burden will vary, depending on the
complexity of the issues raised by a particular application.  A State
determination and certification of an applicant with a large discharge
from multiple pollutant sources may take more time to review than an
application from a small POTW.  EPA(s past experiences have involved a
wide range of extremes from relatively simple to complex applications,
and this experience has been considered in developing typical burdens. 
In addition, EPA has not specified in detail the nature of the States(
submissions, nor has EPA required the States to follow certain review
procedures.  As a result, the burden will also vary depending on the
level of effort and review procedures that the State chooses to adopt in
reaching its concurrence decision.  The burden in providing 401
certification under 40 CFR Part 124 similarly draws on Agency experience
and reflects the fact that the work done by the State in making its
determinations under 40 CFR Part 125 will not be duplicated at the 401
certification stage.  The effort required to complete these activities
is estimated in Table A-9 of the appendix.  The numbers of respondents
and burden hours for State determinations and State certifications for
the 3 years covered by this ICR are presented in Tables A-10 and A-11 of
the appendix.  The average annual burdens for all six information
collection activities are summarized in Table A-12 of the appendix.

14.  Reasons for Change in Burden

Since the last ICR was submitted, the universe of POTWs in the 301(h)
program and subject to the 301(h) information requirements has
decreased.  This is because a POTW has withdrawn from the program. 
There are also changes in the distribution of the burden over the 3
years covered by this ICR because of changes in program status and
information needs.  As a result, information requirements and the total
burden hours in the current ICR are reduced.  Table A-13 of the appendix
explains the reasons for the changes.  The average annual burden
estimate for this ICR is 61377 hours.

15.  Scheduling

This information collection activity does not involve a survey.

16.  Standard Industrial Classification (SIC)

The SIC number for POTWs (sewerage systems) is 4952, and the SIC number
for State governments is 9511.

17.  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 652 hours per response for POTWs
and 86 hours per response for States.  Burden means the total time,
effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a Federal
agency.  This includes the time needed to review instructions; develop,
acquire, install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.  An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a
currently valid OMB control number.  The OMB control numbers for EPA's
regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.  

Send comments on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including through the use of automated collection
techniques to the Director, Office of Information Collection, Collection
Strategies Division (2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue, NW, Washington, D.C. 20460; and to the Office of
Information and Regulatory Affairs, Office of Management and Budget, 725
17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. 
Include the EPA ICR number and OMB control number in any correspondence.

B.  COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

This information collection activity does not employ statistical
methods.



	APPENDIX

See docket attachment 1--ICRtables_301h clean final 2005f for Draft
Supporting Statement tables

Draft for public review with First federal Register Notice—Has not
been submitted to OMB December 2008 Submitted to OMB with Second Federal
Register Notice 

Draft for public review with First federal Register Notice—Has not
been submitted to OMB December 2008

Submitted to OMB with Second Federal Register Notice 

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Draft for public review with First federal Register Notice—Has not
been submitted to OMB December 2008

Submitted to OMB with Second Federal Register NoticeDraft for public
review with First Federal Register Notice(Has not been submitted to OMB
April 2005

