0138ss11-2018 2nd FR 301h-Supporting Statement

Submitted to OMB with Second Federal Register Notice-2018

INFORMATION COLLECTION REQUEST (ICR)
SUPPORTING STATEMENT
FOR THE 301(h) PROGRAM
Modification of Secondary Treatment Requirements for Discharges into Marine Waters,
EPA ICR Number 0138.11, OMB Control Number 2040-0088

JUNE 2017

Submitted to OMB with Second Federal Register Notice-2018

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 ...................................................................................................................7
3(e) General Guidelines .............................................................................................................................................7
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 .............. 15
5(a) Agency Activities ............................................................................................................................................. 15
5(b) Collection Methodology and Management ...................................................................................................... 15
5(c) Small Entity Flexibility .................................................................................................................................... 16
5(d) Collection Schedule ......................................................................................................................................... 16
6. Estimating The Burden and Cost of the Collection ................................................................................................. 16
6(a) Estimating Respondent Burden ........................................................................................................................ 16
6(b) Estimating Respondent Costs ........................................................................................................................... 18
(i) Estimating Labor Costs ................................................................................................................................... 18
(ii) Estimating Capital and Operations and Maintenance Costs .......................................................................... 18
6(c) Estimating Agency Burden and Cost ............................................................................................................... 18
6(d) Estimating the Respondent Universe and Total Burden and Costs .................................................................. 18
6(e) Bottom Line Burden Hours and Cost Tables.................................................................................................... 18
6(f) Reasons for Change in Burden ......................................................................................................................... 20
6(g) Burden Statement ............................................................................................................................................. 20

2

Submitted to OMB with Second Federal Register Notice-2018

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 0138.11,
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.
3

Submitted to OMB with Second Federal Register Notice-2018

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

4

Submitted to OMB with Second Federal Register Notice-2018

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
5

Submitted to OMB with Second Federal Register Notice-2018

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 June 29,2017, (82 FR 29545). EPA
received only one comment, which was submitted by an anonymous commenter urging that there should be no
change to marine sanctuary laws and noting that a marine sanctuary protects waters and wildlife. EPA responds that
the proposed ICR would not affect marine sanctuaries or protections afforded by marine sanctuaries, but instead
addressed the information burdens associated with applications for renewal of permits authorizing discharges from
publicly owned treatment works into ocean waters with limits that protect water quality, but at levels above the
technology-based levels otherwise applicable under the Clean Water Act. EPA did not receive other comments
relevant to the information burden associated with the ICR and did not make any changes to the proposal based on
the public comments. The Clean Water Act directs EPA to administer the 301(h) program based on a facility-byfacility, site-specific analysis for each application. EPA takes into account the quality of the receiving waters and
hydrodynamic conditions, the outfall location and design, the volumes, and quality of the discharge, among other
factors. This analysis and evaluation by its nature requires more than limited information common to all facilities
discharging pursuant to 301(h) modified permits, each of which discharges pursuant to different permit terms
reflecting the modifications that are appropriate for each such permittee.

3(c) Consultations
Lines of communication with the small known universe of 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.
EPA solicited comments on the information collection request during initial rule promulgation as well as
during each renewal of the ICR over the past two decades, and as such the current estimates are well established. As
6

Submitted to OMB with Second Federal Register Notice-2018

noted above, EPA received only one comment during the most recent that did not address the substantive content of
the ICR.

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.

7

Submitted to OMB with Second Federal Register Notice-2018

TABLE 1. STATUS OF POTWs AS OF MARCH 2017
Current 301(h) Waiver Recipients
Name

State

EPA REGION I
Bayville Village
Eastport
Eastport/Quoddy
Lubec
North Haven
Northport Village (Belfast)
Searsport
Stonington
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)*

ME
ME
ME
ME
ME
ME
ME
ME
MA
PR
PR
PR
PR
PR
AS
AS
CA
CA
CA

EPA REGION X
Anchorage
Haines
Ketchikan
Pelican
Petersburg
Sitka
Skagway
Whittier
Wrangell

AK
AK
AK
AK
AK
AK
AK
AK
AK

Total = 28

8

Submitted to OMB with Second Federal Register Notice-2018

*San Diego reapplied for a 301(h) modified permit 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

9

Submitted to OMB with Second Federal Register Notice-2018

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
10

Submitted to OMB with Second Federal Register Notice-2018

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 (Reapplication)

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

Once every five years beginning
with permit issuance.

Application Revision

301(h) waiver renewal 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.

11

Submitted to OMB with Second Federal Register Notice-2018

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.
Applicants approved for 301(h) renewal submit permit reissuance information 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
12

Submitted to OMB with Second Federal Register Notice-2018

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 follow-on systems, or an equivalent database, described in Section 3, as determined by the EPA Regional Office.

13

Submitted to OMB with Second Federal Register Notice-2018

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.
14

Submitted to OMB with Second Federal Register Notice-2018

•

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
developed a 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 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.
15

Submitted to OMB with Second Federal Register Notice-2018

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:
16

Submitted to OMB with Second Federal Register Notice-2018

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 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
17

Submitted to OMB with Second Federal Register Notice-2018

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.
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
$1,074,925 for POTWs and $37,210 for States. Total annual labor costs are thus estimated to be $1,112,135.

(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 $368,939 and the total annual burden is 6,968 hours.

6(d) Estimating the Respondent Universe and Total Burden and Costs
There are 28 POTWs and 6 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 40,040 hours and $1,112,135.

6(e) Bottom Line Burden Hours and Cost Tables

18

Submitted to OMB with Second Federal Register Notice-2018

TABLE A-12. SUMMARY TABLEa

Respondent/Activity

Average
Annual
Burden

Number of
Respondents/Responses

Hours per
Responseb

2
6
28
28

896
440
686
540

1791
2641
19,208
15,120
38,760

8
8

120
40

6

960
320
1280

34

40,040

POTWs
Application Revision
Reapplication
Monitoring Program
Toxics Control Program
TOTAL: POTWs
STATES
Determinations
Certifications
TOTAL: STATES
TOTAL: POTWs AND
STATES

28

a

Average of 3 years divided by 3.
Hours per response were
calculated by dividing the average
annual burden by the number of
respondents. Values have been
rounded to the nearest hour.
b

TABLE A-2. COST TO POTW AND STATE
Average
Annual
Burden
Hours

Activity
COST TO POTW RESPONDENTS
Application Revision
Reapplication
Monitoring Program
Toxics Control Program
TOTAL
COST TO STATE RESPONDENTS
19

1,791
2,641
19,208
15,120
38,760

Average
Annual
Costs

Hourly
Costs

a

$79.03
a
$79.03
b
$21.11
b
$21.11

$141,543
$208,718
$405,481
$319,183
$1,074,925

Submitted to OMB with Second Federal Register Notice-2018

Determination
Certification
TOTAL

960
320
1,280

TOTAL POTW AND STATE
RESPONDENTS

40,040

c

29.07
c
29.07

$27,907
$9,302
$37,210

$1,112,135

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, $71,467, or $82,187/year. Thus, based on
2,080 working hours/year, the average hourly salary of a contractor is $39.51/hour. Assuming 100 percent
overhead costs for the private sector, the labor cost for contractors is $79.03/hour. (Hourly rate based on 2017
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 $39,911. Based on 2,080 working hours/year, the average hourly salary of a local employee is
$19.19/hour. Assuming 10 percent overhead costs, the labor cost for local government employees is
$21.11hour. (Hourly rate based on 2017 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 $54,972/year. Based on 2,080 working hours/year, the average hourly salary of a State
government employee is $26.43/hour. Assuming 10 percent overhead costs, the labor cost for State
government employees is $29.07/hour. (Hourly rate based on 2017 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, or been
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 9,624 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 606 hours per response for POTWs and 80 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), WJC West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C. The EPA Docket
20

Submitted to OMB with Second Federal Register Notice-2018

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 at [email protected]. Please include the EPA
Docket ID Number EPA-HQ-OW-2003-0033 and OMB Control Number 2040-0088 in any correspondence.

21