INFORMATION COLLECTION REQUEST (ICR)

SUPPORTING STATEMENT

FOR THE 301(h) PROGRAM

Modification of Secondary Treatment Requirements for Discharges into
Marine Waters, EPA ICR Number 0138.09, OMB Control Number 2040-0088

April 2009

  TOC \o "1-3" \h \z \u  

  HYPERLINK \l "_Toc228870458"  1. Identification of the Information
Collection	  PAGEREF _Toc228870458 \h  3  

  HYPERLINK \l "_Toc228870459"  1(a) Title of the Information Collection
  PAGEREF _Toc228870459 \h  3  

  HYPERLINK \l "_Toc228870460"  1(b) Short Characterization/Abstract	 
PAGEREF _Toc228870460 \h  3  

  HYPERLINK \l "_Toc228870461"  2. Need for and use of the Collection	 
PAGEREF _Toc228870461 \h  3  

  HYPERLINK \l "_Toc228870462"  2(a) Need/Authority for the Collection	 
PAGEREF _Toc228870462 \h  3  

  HYPERLINK \l "_Toc228870463"  2(b) Practical Utility/Users of the Data
  PAGEREF _Toc228870463 \h  5  

  HYPERLINK \l "_Toc228870464"  3. Non duplication, Consultations, and
Other Collection Criteria	  PAGEREF _Toc228870464 \h  5  

  HYPERLINK \l "_Toc228870465"  3(a) Non duplication	  PAGEREF
_Toc228870465 \h  5  

  HYPERLINK \l "_Toc228870466"  3(b) Public Notice Required Prior to ICR
submission to OMB	  PAGEREF _Toc228870466 \h  6  

  HYPERLINK \l "_Toc228870467"  3(c) Consultations	  PAGEREF
_Toc228870467 \h  6  

  HYPERLINK \l "_Toc228870468"  3(d) Effects of Less Frequent Collection
  PAGEREF _Toc228870468 \h  6  

  HYPERLINK \l "_Toc228870469"  3(e) General Guidelines	  PAGEREF
_Toc228870469 \h  6  

  HYPERLINK \l "_Toc228870470"  3(f) Confidentiality	  PAGEREF
_Toc228870470 \h  7  

  HYPERLINK \l "_Toc228870471"  3(g) Sensitive Questions	  PAGEREF
_Toc228870471 \h  7  

  HYPERLINK \l "_Toc228870472"  4. The Respondents and the Information
Requested	  PAGEREF _Toc228870472 \h  7  

  HYPERLINK \l "_Toc228870473"  4(a) Respondents/NAICS Codes	  PAGEREF
_Toc228870473 \h  7  

  HYPERLINK \l "_Toc228870474"  4(b) Information Requested	  PAGEREF
_Toc228870474 \h  9  

  HYPERLINK \l "_Toc228870475"  (i) Data items, including record keeping
requirements; Respondent Activities	  PAGEREF _Toc228870475 \h  9  

  HYPERLINK \l "_Toc228870476"  5. The Information Collected–Agency
Activities, Collection Methodology, and Information Management	  PAGEREF
_Toc228870476 \h  14  

  HYPERLINK \l "_Toc228870477"  5(a) Agency Activities	  PAGEREF
_Toc228870477 \h  14  

  HYPERLINK \l "_Toc228870478"  5(b) Collection Methodology and
Management	  PAGEREF _Toc228870478 \h  14  

  HYPERLINK \l "_Toc228870479"  5(c) Small Entity Flexibility	  PAGEREF
_Toc228870479 \h  15  

  HYPERLINK \l "_Toc228870480"  5(d) Collection Schedule	  PAGEREF
_Toc228870480 \h  15  

  HYPERLINK \l "_Toc228870481"  6. Estimating The Burden and Cost of the
Collection	  PAGEREF _Toc228870481 \h  15  

  HYPERLINK \l "_Toc228870482"  6(a) Estimating Respondent Burden	 
PAGEREF _Toc228870482 \h  15  

  HYPERLINK \l "_Toc228870483"  6(b) Estimating Respondent Costs	 
PAGEREF _Toc228870483 \h  16  

  HYPERLINK \l "_Toc228870484"  (i) Estimating Labor Costs	  PAGEREF
_Toc228870484 \h  17  

  HYPERLINK \l "_Toc228870485"  (ii) Estimating Capital and Operations
and Maintenance Costs	  PAGEREF _Toc228870485 \h  17  

  HYPERLINK \l "_Toc228870486"  6(c) Estimating Agency Burden and Cost	 
PAGEREF _Toc228870486 \h  17  

  HYPERLINK \l "_Toc228870487"  6(d) Estimating the Respondent Universe
and Total Burden and Costs	  PAGEREF _Toc228870487 \h  17  

  HYPERLINK \l "_Toc228870488"  6(e) Bottom Line Burden Hours and Cost
Tables	  PAGEREF _Toc228870488 \h  17  

  HYPERLINK \l "_Toc228870489"  6(f) Reasons for Change in Burden	 
PAGEREF _Toc228870489 \h  18  

  HYPERLINK \l "_Toc228870490"  6(g) Burden Statement	  PAGEREF
_Toc228870490 \h  19  

 

1.  tc "Introduction to Part A " \l 2 Identification of the Information
Collection

	1(a) Title of the Information Collection

Modification of Secondary Treatment Requirements for Discharges into
Marine Waters, EPA ICR Number 0138.09, OMB Control Number 2040-0088

	1(b) Short Characterization/Abstract

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

2. Need for and use of the Collection

	2(a) Need/Authority for the Collection

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, and 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 non-point 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
non-industrial 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 non-industrial 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 on February 4,
1987.  WQA section 303(c) requires each 301(h) waiver applicant serving
a population of over 50,000 persons 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 non-point 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.

	2(b) Practical Utility/Users of the Data

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 and filed.

3. Non duplication, Consultations, and Other Collection Criteria

	3(a) Non duplication

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 Non-duplication 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 EPA office coordinating
the 301(h) program.

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. 
EPA has also developed an extensive, comprehensive set of technical
monitoring guidance to aid POTWs in the efficient planning, design and
conduct of field data collection.  This kind of structured communication
ensures that available information is used to the maximum 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 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.

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

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.),
EPA requested comment from the public on this ICR through a Federal
Register notice published on December 29, 2008 (73 FR 79467). EPA
received one comment on this current information collection request that
did not address the substance of this ICR.  Response:  The change of
Presidential administrations and timing of EPA's actions to renew the
expiring information collection request are purely coincidental.  Under
the Paperwork Reduction Act, approval of EPA's information collection
request is scheduled to expire on May 31, 2009.  EPA begins the
regulatory processes for timely renewal of expiring information
collection requests, including prior notice and opportunity for public
comment, in advance of such expirations and in the normal course of
Agency business.  EPA does so in order to assure the opportunity for
timely renewal in order that continuous Agency operations affected by
the information collection can proceed without interruption.

	3(c) 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; 70 FR 35082,
June 16, 2005; and 73 FR 79467, December 29, 2008).  EPA received no
comments on any previous ICRs.  

	3(d) Effects of Less Frequent Collection

Application revision information is submitted once and 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 necessary to conduct the 301(h) program;
frequency can be minimized because the requirement is developed for each
respondent based on its particular circumstances.

	3(e) General Guidelines

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

	3(f) 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.

3(g) Sensitive Questions

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

4. The Respondents and the Information Requested

	4(a) Respondents/NAICS Codes

Respondents are those municipalities that currently have section 301(h)
waivers from secondary treatment, have applied for a renewal of a
section 301(h) waiver, and the States within which these municipalities
are located. The SIC number for POTWs (sewerage systems) is 22132, and
the SIC number for State governments is 92411.

As indicated previously, 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 APRIL 2009

Current 301(h) Waiver Recipients



Name	

State	





EPA REGION I

Bayville Village

Bucksport

Eastport

Eastport/Quoddy

Jonesport

Lubec

Milbridge

Newton Highlands (Squirrel Is)

North Haven

Northport Village (Belfast)

Searsport

Winterport

Gloucester

Gosnold

EPA REGION II

Aguadilla

Arecibo

Bayamon/Puerto Nuevo

Carolina

Ponce

EPA REGION IX

Tafuna (Pago Pago)

Utulei

Goleta

Morro Bay

San Diego (Pt. Loma)*

Honouliuli (Honolulu)

Sand Island (Honolulu)

Agana

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

MA

MA

PR

PR

PR

PR

PR

AS

AS

CA

CA

CA

HI

HI

GU

GU

AK

AK

AK

AK

AK

AK

AK

AK

AK	

 

 



Total = 37

*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.

	4(b) Information Requested

		(i) Data items, including record keeping requirements; Respondent
Activities

	

Program Status and Information Needs

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 three-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 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 greater
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 non-industrial 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 non-point
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.

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 that 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 non-point 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 five 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 five 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 to 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.  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 and can be easily retrieved, or stored
and analyzed in the new STORET Office of Water Storage and Retrieval
System or an equivalent database, described in Section 3, 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 non-industrial toxics control programs.  POTWs must develop a public
education program for non-industrial 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 non-point 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 that
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 must be 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.

5. The Information Collected–Agency Activities, Collection
Methodology, and Information Management

	5(a) Agency Activities

	Agency activities are discussed in conjunction with the respondent
activities in section 4(b)(i) above.

	5(b) Collection Methodology and Management

EPA 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 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 these databases 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 these databases 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.

	5(c) Small Entity Flexibility

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 persons 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.

	5(d) Collection Schedule

Application revision information is submitted once and 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. The frequency of collection for monitoring and toxics
program information is determined on a case-by-case basis.

6. Estimating the Burden and Cost of the Collection

	6(a) Estimating 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 three 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 non-industrial 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 three 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.

	6(b) Estimating Respondent Costs

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.  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.

		(i) Estimating Labor Costs

	Detailed estimates for labor costs are shown in Table A-2 of the
appendix. The average annual labor cost is $1,456,507 for to POTWs and
$46,763 for States. Total annual labor costs are thus estimated to be
$1,503,270.

		(ii) Estimating Capital and Operations and Maintenance Costs

	There are no Capital or Operations and Maintenance costs associated
with maintaining a Section 301(h) waiver.

	

	6(c) Estimating Agency Burden and Cost

	Detailed estimates for cost and burden to the EPA are shown in Tables
A-1 and A-3, respectively. The total annual cost is $483,101 and the
total annual burden is 9,993

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

	There are 37 POTWs and 8 States who will respond during the three-year
period of this ICR. Total burden and costs are detailed in the attached
tables and copied in the following section. The total annual burden to
states and POTWs is 59,370 hours and $1,503,270.

	6(e) Bottom Line Burden Hours and Cost Tables

TABLE A-12.  SUMMARY TABLEa

Respondent/Activity	Number of Respondents/Responses	Hours per Responseb
Average Annual Burden

POTWs	 



Application Revision	3	853	2,559

Reapplication	7	566	3,963

Monitoring Program	37	754	27,888

Toxics Control Program	37	627	23,200

TOTAL: POTWs	37	 	57,610

STATES	 



Determinations	10	132	1,320

Certifications	10	44	440

TOTAL: STATES	8	 	1,760

TOTAL:  POTWs AND STATES	45	 	59,370

aAverage of 3 years divided by 3.



	 b Hours per response were calculated by dividing the average annual
burden by the number of respondents.  Values have been rounded to the
nearest hour. 



	

TABLE A-2.  COST TO POTW AND STATE RESPONDENTS

Activity	 Average Annual Burden Hours 	Hourly Cost	 	Average Annual
Cost

COST TO POTW RESPONDENTS

Application Revision	     2,559 	$72.22	a	$184,811

Reapplication	     3,963 	$72.22	a	$286,208

Monitoring Program	   27,888 	$19.29	b	$537,960

Toxics Control Program	   23,200 	$19.29	b	$447,528

TOTAL	   57,610 

	$1,456,507

COST TO STATE RESPONDENTS



 

Determination	1,320	26.57	c	$35,072

Certification	440	26.57	c	$11,691

TOTAL	     1,760 	 	 	$46,763

TOTAL POTW AND STATE RESPONDENTS	   59,370 	 	 	$1,503,270

aIt is assumed that much of the reapplication and additional information
is prepared by a contractor with specialized expertise and equipment. 
It is further assumed that the salary level of a contractor working on
the 301(h) program is 15 percent higher than that of a GS-9, Step 10,
$65,531, or $75,361/year.  Thus, based on 2,080 working hours/year, the
average hourly salary of a contractor is $36.11/hour.  Assuming 100
percent overhead costs for the private sector, the labor cost for
contractors is $72.22/hour.  (Hourly rate based on 2009 DC-B salary rate
table.)

bIt is assumed that the salary level of a typical local government
employee working on the 301(h) program is a GS-5, Step 4, or $36,596. 
Based on 2,080 working hours/year, the average hourly salary of a local
employee is $17.54/hour.  Assuming 10 percent overhead costs, the labor
cost for local government employees is $19.29/hour.  (Hourly rate based
on 2009 DC-B salary rate table.)

cIt is assumed that the salary level of a typical State government
employee working on the 301(h) program is a GS-9, Step 1, or
$50,408/year.  Based on 2,080 working hours/year, the average hourly
salary of a State government employee is $24.15/hour.  Assuming 10
percent overhead costs, the labor cost for State government employees is
$26.57/hour.  (Hourly rate based on 2009 DC-B salary rate table.)

	

6(f) 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 three POTWs have withdrawn from the program,
and one POTW was denied a waiver renewal.  Also, there is one fewer
State respondent.  There are also changes in the distribution of the
burden over the three years covered by this ICR because of changes in
program status and information needs.  As a result, the total burden in
the current ICR has been reduced by 2,007 hours.  Table A-13 of the
appendix explains the reasons for the changes. 

	6(g) Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 686 hours per response for POTWs
and 88 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.  

	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 Number
EPA-HQ-OW-2003-0033, which is available for online viewing at
www.regulations.gov, or in person viewing at the Water Docket in the EPA
Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue,
NW, Washington, D.C.  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 at
www.regulations.gov.  This site can be used 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.  When 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, D.C. 20503, Attention: Desk
Officer for EPA.  Please include the EPA Docket ID Number
EPA-HQ-OW-2003-0033 and OMB Control Number 2040-0088 in any
correspondence.

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