Supporting Statement and Tables to be Revised for 2014 ICR Renewal

Submitted with First Federal Register Notice for ICR Renewal 09/24/2013

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

Formatted: Font color: Red
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1. Identification of the Information Collection ..............................................................................................................3

1(a) Title of the Information Collection ....................................................................................................................3

1(b) Short Characterization/Abstract.........................................................................................................................3

2. Need for and use of the Collection ............................................................................................................................3

2(a) Need/Authority for the Collection......................................................................................................................3

2(b) Practical Utility/Users of the Data .....................................................................................................................5

3. Non duplication, Consultations, and Other Collection Criteria .................................................................................5

3(a) Non duplication..................................................................................................................................................5

3(b) Public Notice Required Prior to ICR submission to OMB.................................................................................6

3(c) Consultations......................................................................................................................................................6

3(d) Effects of Less Frequent Collection ...................................................................................................................6

3(e) General Guidelines.............................................................................................................................................6

3(f) Confidentiality ....................................................................................................................................................7

3(g) Sensitive Questions............................................................................................................................................7

4. The Respondents and the Information Requested .....................................................................................................7

4(a) Respondents/NAICS Codes ...............................................................................................................................7

4(b) Information Requested.......................................................................................................................................9

(i) Data items, including record keeping requirements; Respondent Activities.....................................................9

5. The Information Collected–Agency Activities, Collection Methodology, and Information Management..............14

5(a) Agency Activities.............................................................................................................................................14

5(b) Collection Methodology and Management......................................................................................................14

5(c) Small Entity Flexibility ....................................................................................................................................15

5(d) Collection Schedule .........................................................................................................................................15

6. Estimating The Burden and Cost of the Collection .................................................................................................15

6(a) Estimating Respondent Burden ........................................................................................................................15

6(b) Estimating Respondent Costs...........................................................................................................................16

(i) Estimating Labor Costs...................................................................................................................................17

(ii) Estimating Capital and Operations and Maintenance Costs ..........................................................................17

6(c) Estimating Agency Burden and Cost ...............................................................................................................17

6(d) Estimating the Respondent Universe and Total Burden and Costs..................................................................17

6(e) Bottom Line Burden Hours and Cost Tables....................................................................................................17

6(f) Reasons for Change in Burden .........................................................................................................................18

6(g) Burden Statement.............................................................................................................................................19
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1. 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-thansecondary 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.
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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 
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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 
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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).
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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.
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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
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*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 
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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.
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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.
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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.
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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.
14

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.
15

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.
16

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 nonindustrial source control programs.

The burdens for State determinations and State certifications activities are summarized in Tables A-9, A10, 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 
17

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

a

Average 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. 
18

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

a

It 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.)

b

It 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.)

c

It 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 
19

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.