1895ss04

1895ss04.pdf

Microbial Rules (Renewal)

OMB: 2040-0205

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Draft Information
Collection Request for the
Microbial Rules

TABLE OF CONTENTS
1
1(a)
1(b)
2
2(a)
2(b)
3
3(a)
3(b)
3(c)
3(d)
3(e)
3(f)
3(g)
4
4(a)
4(b)
5
5(a)
5(b)
5(c)
5(d)
6
6(a)
6(b)
6(c)
6(d)
6(e)
6(f)
6(g)

IDENTIFICATION OF THE INFORMATION COLLECTION........................... 1
Title and Number of the Information Collection.................................................... 1
Short Characterization ............................................................................................ 1
NEED FOR AND USE OF THE COLLECTION.................................................. 3
Need/Authority for the Collection.......................................................................... 3
Use/Users of the Data ............................................................................................. 9
NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION
CRITERIA ............................................................................................................ 10
Non-duplication .................................................................................................... 10
Public Notice Required Prior to ICR Submission to OMB .................................. 10
Consultations ........................................................................................................ 10
Effects of Less Frequent Collection ..................................................................... 12
General Guidelines ............................................................................................... 12
Confidentiality ...................................................................................................... 12
Sensitive Questions .............................................................................................. 12
RESPONDENTS AND INFORMATION REQUESTED ................................... 13
Respondents/NAICS Codes.................................................................................. 13
Information Requested ......................................................................................... 13
INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT.......................... 38
Agency Activities ................................................................................................. 38
Collection Methodology and Management .......................................................... 40
Small Entity Flexibility ........................................................................................ 41
Collection Schedule.............................................................................................. 43
ESTIMATING BURDEN AND COST OF COLLECTION................................ 44
Respondent Burden............................................................................................... 45
Respondent Costs ................................................................................................. 49
Agency Burden and Costs .................................................................................... 51
Estimating Respondent Universe and Total Burden and Costs............................ 51
Bottom Line Burden Hours and Costs.................................................................. 52
Reasons for Change in Burden ............................................................................. 53
Burden Statement ................................................................................................. 58

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APPENDICES
Appendix A. Federal Register Notice Soliciting Comments on Information Collection
Requests
Appendix B. Surface Water Treatment Rule Spreadsheets
Appendix C. Total Coliform Rule Spreadsheets
Appendix D. Interim Enhanced Surface Water Treatment Rule Spreadsheets
Appendix E. Long Term 1 Enhanced Surface Water Treatment Rule Spreadsheets
Appendix F.

Long Term 2 Enhanced Surface Water Treatment Rule Spreadsheets

Appendix G. Ground Water Rule Spreadsheets

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LIST OF EXHIBITS
Exhibit 1: Structure of OGWDW ICRs ................................................................................... 6
Exhibit 2: PWS Recordkeeping and Reporting Requirements .............................................. 14
Exhibit 3: Primacy Agency Recordkeeping and Reporting Requirements............................ 19
Exhibit 4: EPA Requirements................................................................................................ 39
Exhibit 5: Collection Schedule .............................................................................................. 43
Exhibit 6: Annual PWS Burden and Cost, October 1, 2008 – September 30, 2011.............. 51
Exhibit 7: Annual Primacy Agency Burden and Cost, October 1, 2008 –
September 30, 2011 .............................................................................................. 51
Exhibit 8: Bottom Line Annual Burden and Cost, October 1, 2008 –
September 30, 2011 .............................................................................................. 53
Exhibit 9: Summary of Changes in Annual Burden (Includes PWS and Primacy Agency
Burden) ................................................................................................................. 54
Exhibit 10: Restructuring Adjustments to the Annual Burden Inventory for the Microbial
Rules ICR (Includes PWS and Primacy Agency Burden) .................................... 55
Exhibit 12: Adjustments to Primacy Agency Burden from Previous ICR Estimates............. 57
Exhibit 13: Adjustments to Annual Burden Carried Forward from Previous ICR
Estimates (Includes PWS and Primacy Agency Burden) ..................................... 58

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iii

LIST OF FIGURES
Figure 1:

Structure of OGWDW ICRs

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ACRONYMS
CCP
CCR
CDC
CFE
CFR
CPE
CT
CWS
CWSS
DBPR
DDBP/Chem/Rads
DWSRF
EPA
ESWTR
FBRR
FR
FTE
GWR
GWUDI
HAA5
HPC
ICR
IESWTR
IFA
LT1ESWTR
LT2ESWTR
MCL
MCLG
NAICS
NCWS
NPDWRs
NTNCWS
NTU
O&M
OGWDW
OMB
PN
PRA
PWS
PWSS
RegNeg
RIA
RFA
SBARP
SBREFA
SCADA
SDWA
SDWIS

Composite Correction Program
Consumer Confidence Report
Centers for Disease Control and Prevention
Combined Filter Effluent
Code of Federal Regulations
Comprehensive Performance Evaluation
Contact Time
Community Water System
Community Water System Survey
Disinfectants and Disinfection Byproducts Rule
Disinfectants and Disinfection Byproducts, Chemical, and
Radionuclides
Drinking Water State Revolving Fund
Environmental Protection Agency
Enhanced Surface Water Treatment Rule
Filter Backwash Recycling Rule
Federal Register
Full Time Equivalent
Ground Water Rule
Ground Water Under the Direct Influence of Surface Water
Haloacetic Acids
Heterotrophic Plate Count
Information Collection Request
Interim Enhanced Surface Water Treatment Rule
Individual Filter Assessment
Long Term 1 Enhanced Surface Water Treatment Rule
Long Term 2 Enhanced Surface Water Treatment Rule
Maximum Contaminant Level
Maximum Contaminant Level Goal
North American Industry Classification System
Noncommunity Water System
National Primary Drinking Water Regulations
Nontransient Noncommunity Water System
Nephelometric Turbidity Unit
Operation and Maintenance
Office of Ground Water and Drinking Water
Office of Management and Budget
Public Notification
Paperwork Reduction Act
Public Water System
Public Water System Supervision
Regulatory Negotiation
Regulatory Impact Analysis
Regulatory Flexibility Analysis
Small Business Advocacy Review Panel
Small Business Regulatory Enforcement Fairness Act
Supervisory Control and Data Acquisition
Safe Drinking Water Act
Safe Drinking Water Information System

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SER
SOC
SNC
SWAP
SWTR
TCR
TTHM
UIC
V&Es

Small Entity Representative
Standard Occupational Classification
Significant Non-Compliance
Source Water Assessment Program
Surface Water Treatment Rule
Total Coliform Rule
Total Trihalomethanes
Underground Injection Program
Variances and Exceptions

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Microbial Rules ICR

September 2008

IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)

Title and Number of the Information Collection
Title: Information Collection Request for the Microbial Rules

1(b)

OMB Control Number:

2040-0205

EPA Tracking Number:

1895.04

Short Characterization

The Office of Ground Water and Drinking Water (OGWDW) at the U.S. Environmental
Protection Agency (EPA or the Agency) is responsible for developing National Primary
Drinking Water Regulations (NPDWRs) as mandated by the Safe Drinking Water Act (SDWA).
Section 1412 of the SDWA requires EPA to establish NPDWRs for contaminants that may
adversely impact human health. The Act further requires EPA to monitor and enforce these
regulations to ensure that the nation’s drinking water dependably complies with the maximum
contaminant levels (MCLs) stipulated in the Code of Federal Regulations (CFR), 40 CFR Part
141, Subpart B.
Section 1445 of the SDWA stipulates that every drinking water supplier must conduct
monitoring, maintain records, and provide such information as is needed for EPA to implement
its monitoring and enforcement responsibilities with respect to the Act. State1 governments—in
those states that have assumed primary enforcement responsibility (primacy) for public water
systems (PWSs) under SDWA Section 1413—ensure that PWSs are complying with these
monitoring requirements. As part of the Public Water System Supervision (PWSS) Program, the
OGWDW uses the Safe Drinking Water Information System (SDWIS) to record some of the data
collected as a result of NPDWR requirements. SDWIS is a database management system that
assists EPA in tracking and interpreting monitoring data and other program-related data. These
data assist EPA in fulfilling its SDWA obligations.
This Information Collection Request (ICR) was prepared in accordance with the
November 2005 version of EPA’s Guide to Writing Information Collection Requests Under the
Paperwork Reduction Act (PRA) of 1995 (or “ICR Handbook”) prepared by EPA’s Office of
Environmental Information, Office of Information Collection, Collection Strategies Division.
The ICR Handbook provides the most current instructions for ICR preparation to ensure
compliance with the 1995 PRA amendments and the Office of Management and Budget’s
(OMB’s) implementing guidelines.

Throughout this document, the terms “State” or “states” are used to refer to all types of primacy agencies. There
are currently 57 primacy agencies, including the 50 States, the District of Columbia, U.S. territories (Puerto Rico,
U.S. Virgin Islands, Guam, American Samoa, and Northern Marianas), and Navajo Nation. Though Wyoming and
the District of Columbia do not have primacy, the EPA burden for these activities is counted as primacy agency
burden.

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Microbial Rules ICR

September 2008

This ICR examines PWS, primacy agency, and EPA burden and costs for recordkeeping
and reporting required in support of microbial contaminant-associated rulemakings. These rules
include the following—
1)
2)
3)
4)
5)
6)
7)

Surface Water Treatment Rule (SWTR)2
Total Coliform Rule (TCR)
Interim Enhanced Surface Water Treatment Rule (IESWTR)
Filter Backwash Recycling Rule (FBRR)
Long Term 1 Enhanced Surface Water Treatment Rule (LT1ESWTR)
Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR)3
Ground Water Rule (GWR)4

This ICR estimates burden and costs for October 1, 2008, and September 30, 2011, for
the rules above. It updates the burden and cost estimates provided in the Microbial Rules ICR
dated November 2004, which expires on September 30, 2008. This ICR includes burden for the
GWR only for the period after October 31, 2009. GWR burden incurred prior to this date is
addressed in the stand-alone ICR for that rule. The burden and cost estimates for each rule are
discussed in greater detail in Section 6 of this document.
Continuing costs and burden for several existing drinking water regulations are evaluated
in this ICR. The total annual burden associated with this ICR is estimated to be approximately
10.7 million hours per year. The total annual cost associated with this ICR is estimated to be
approximately $554.0 million. The distribution of annual burden between PWSs and primacy
agencies is approximately 8.5 million hours and 2.1 million hours, respectively. The distribution
of annual costs between PWSs and primacy agencies is approximately $462.1 million and $91.9
million, respectively. There is no Agency burden or cost for this ICR. Section 6 and Appendices
B through H detail these burden and cost calculations.
The approximate annual operation and maintenance (O&M) and capital costs are $197.2
million ($110.6 million for O&M and $86.6 million for capital). This represents the “cost
burden” as reported in the OMB inventory. Note that these costs are for PWSs only; primacy
agencies do not have capital or O&M costs associated with the Microbial Rules.
The total number of respondents for this ICR is 155,750; 57 of these respondents are
primacy agencies and the balance are existing PWSs (155,693). The total annual number of
responses for these respondents is 12.1 million (10.1 million for PWSs and 2.0 million for
primacy agencies).

This Microbial Rules ICR includes all SWTR components except disinfectant residual monitoring and associated
activities, which are included in the Disinfectants and Disinfection Byproducts, Chemical, and Radionuclides
(DDBP/Chem/Rads) Rules ICR (see section 4(b)(i)).
3

The burden for this rule was previously addressed in stand-alone ICR OMB #2040-0266. It is being incorporated
into the Microbial Rules ICR for the first time.
4

The burden for this rule was previously addressed in stand-alone ICR OMB #2040-0271. It is being incorporated
into the Microbial Rules ICR for the first time.
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Microbial Rules ICR

NEED FOR AND USE OF THE COLLECTION

2(a)

Need/Authority for the Collection

September 2008

This section identifies the regulatory or statutory authority for the information collection
activities covered in this ICR and describes why EPA needs the information. Section 4 contains
a summary of the major recordkeeping and reporting requirements for rules covered by this ICR.
The Microbial Rules ICR includes the following rules addressing microbial
contaminants—
1)
2)
3)
4)
5)
6)
7)

Surface Water Treatment Rule
Total Coliform Rule
Interim Enhanced Surface Water Treatment Rule
Filter Backwash Recycling Rule
Long Term 1 Enhanced Surface Water Treatment Rule
Long Term 2 Enhanced Surface Water Treatment Rule
Ground Water Rule

As EPA publishes new regulations, EPA will amend the appropriate ICR to include the
new rules.
For a graphical depiction of the structure of the OGWDW ICRs, see Figure 1. A
complete itemization of the activities included in the three primary ICRs, as well as other
drinking water program ICRs, is included as Exhibit 1.
The information collected under this ICR is required by EPA to carry out its monitoring
and enforcement responsibilities under SDWA. Without comprehensive, up-to-date information
on chemical contaminants present in drinking water, the Agency would not be able to meet the
SDWA statutory requirements.
§ 1401 of the SDWA requires that—
there must be criteria and standards to assure a supply of drinking water which dependably
complies with such maximum contaminant levels; including quality control and testing
procedures to insure compliance with such levels and to insure proper operation and
maintenance of the system...
Further, §1445 of the SDWA requires that—
every person who is a supplier of water shall establish and maintain such records, make such
reports, conduct such monitoring, and provide such information as the Administrator may
reasonably require by regulation to assist him in establishing regulations, in determining
whether such person has acted or is in compliance with this title...

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Microbial Rules ICR

September 2008

In addition, §1401(1)(d) of the SDWA 1986 Amendments defines NPDWRs to include
“criteria and procedures to assure a supply of drinking water which dependably complies with
such maximum contaminant levels; including accepted methods for quality control and testing
procedures ...” This section authorizes EPA to require systems and laboratories to use Agencyapproved methods and quality assurance criteria for collecting and analyzing water samples.

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Microbial Rules ICR

September 2008

Figure 1. Structure of OGWDW ICRs
Microbial Rules ICR

PWSS Program ICR

UIC Program ICR

2040-0205

2040-0090

2040-0042

FBRR

TCR

State
Primacy
Activities

IESWTR

SWTR

CCRs

Cap Dev

Class V

LT1

GWR

Op Cert

Tribal Op
Cert

Constructed
Conveyances

Florida
Class I

Proficiency
Testing

V&E’s

UIC Program

LT2

UCMR 2
2040-0270

DDBP/Chem/Rads Rules ICR
2040-0204

Chems

Arsenic

LCR

Rads

LCR
STR

Stage 1

Stage 2

ADWR

Lab QA
2040-0246

Bioterrorism
2040-0253

DW SRF
2040-0185

Needs Survey
2040-0251

SWAP
2040-0197

Green = Activities remain as in current
ICR
Blue = Activities moving out of standalone ICRs
Purple = Future rule to be addressed in
stand-alone ICR
DDBP/Chem/Rads Rules ICR includes
disinfectant residual monitoring under SWTR

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Microbial Rules ICR

September 2008

Exhibit 1: Structure of OGWDW ICRs
Currently covered

To be covered in the future

PWSS Program ICR (2040-0090)
Consumer Confidence Reports (CCRs)
Proficiency Testing
Variances & Exemptions
The Capacity Development Program
General State Primacy Activities
Public Notification (PN)
Operator Certification Guidelines and Expense
Reimbursement Grants Program
Tribal Operator Certification
Constructed Conveyances
Microbial Rules ICR (2040-0205)
Surface Water Treatment Rule, except disinfectant
residual monitoring and associated activities5
Total Coliform Rule
Interim Enhanced Surface Water Treatment Rule
(IESWTR)
Filter Backwash Recycling Rule
Long Term 1 Enhanced Surface Water Treatment
Rule (LT1ESWTR)
Long Term 2 Enhanced Surface Water Treatment
Rule (LT2ESWTR)
Ground Water Rule
Disinfectants/Disinfection Byproducts, Chemical, and Radionuclides Rules ICR (2040-0204)
Stage 1 Disinfectants and Disinfection Byproducts
Radon
Rule
Disinfectant Residual Monitoring and associated
activities under the SWTR
Stage 2 DBPR
Chemical Phase Rules
Radionuclides Rule
Arsenic Rule
Lead and Copper Rule
Source Water Assessment Program (SWAP) ICR (2040-0197)
SWAP
Underground Injection Control (UIC) Program ICR (2040-0042)
UIC Base Program Activities

Florida Class I Rule

Class V Rule

Disinfectant residual monitoring and associated activities are included in the DDBP/Chem/Rads Rules ICR.
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6

Microbial Rules ICR

Currently covered

September 2008

To be covered in the future

Drinking Water State Revolving Fund (DWSRF) Program ICR (2040-0185)
Drinking Water State Revolving Fund Program
Drinking Water Infrastructure Needs Survey ICR (2040-0251)
2007 Needs Survey
Title VI of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002:
Drinking Water Security and Safety ICR (2040-0253)
Vulnerability Assessments and Emergency
Response Plans for community water systems
(CWSs).

Surface Water Treatment Rule

The 1986 SDWA Amendments required EPA to propose and promulgate a NPDWR
specifying criteria under which filtration would be required as a treatment technique for public
water systems supplied by surface water sources (Section 1412 (b)(7)(C)(i)). In promulgating
this regulation and setting the criteria, EPA was required to consider source water quality;
protection afforded by watershed management programs; treatment techniques, such as
disinfection practices and length of water storage; and other factors relevant to protection of
health. The requirements for the SWTR included in this ICR help EPA promote public health
through proper operation of filtration techniques. Additional SWTR requirements, such as
monitoring and watershed control programs, promote protection of public health in the absence
of filtration.
2)

Total Coliform Rule

The 1986 SDWA Amendments required EPA to publish maximum contaminant level
goals (MCLGs) and promulgate NPDWRs for the 83 contaminants listed in the Advance Notice
of Proposed Rulemaking at 47 FR 45502 (March 4, 1982) and 48 FR 45502 (October 5, 1983).
EPA believes that promulgation of this regulation complied with the statutory requirements for
regulating total coliforms in all PWSs.
3)

Interim Enhanced Surface Water Treatment Rule

SDWA Section 1412(b)(2)(c) requires EPA to promulgate an Interim Enhanced Surface
Water Treatment Rule. The IESWTR sets the first drinking water standards to control
Cryptosporidium in large systems.
4)

Filter Backwash Recycling Rule

SDWA was amended in August 1996, resulting in the addition of new sections that
establish new drinking water requirements. SDWA Section 1412(b)(14) requires the
Administrator to promulgate a regulation to govern the recycling of filter backwash water within
the treatment process of a PWS. The FBRR satisfies this regulatory requirement.
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Microbial Rules ICR

September 2008

Long Term 1 Enhanced Surface Water Treatment Rule

SDWA Section 1412(b)(2)(C) established a number of regulatory deadlines, including
two stages of the Enhanced Surface Water Treatment Rule (ESWTR). The LT1ESWTR is part
of the first stage of the ESWTR. The LT1ESWTR strengthens the standards previously
established under the SWTR and applies the standards set for Cryptosporidium in the IESWTR
to small systems.
6)

Long Term 2 Enhanced Surface Water Treatment Rule

The final LT2ESWTR was promulgated January 5, 2006. Implementation schedules vary
by system size, but burden will include the following:
•
•

•
•
•

Monitoring for E. coli and/or Cryptosporidium (usually monthly but biweekly for
some small systems).
PWSs must calculate a bin classification based on the monitoring results. This
classification will be used to determine treatment requirements. Not all systems
will calculate bin classification during the period covered by the revised ICR.
PWSs must cover any uncovered finished water reservoirs or else provide further
treatment and must develop a plan for doing so.
PWSs that intend to make a significant change in their disinfection practice must
develop a disinfection profile and benchmark for Giardia and viruses.
States will review monitoring results and assist with and review bin
classifications. They will also review documentation associated with covering or
treating uncovered finished water reservoirs and with changing disinfection.
Ground Water Rule

The 1996 SDWA amendments required the Administrator to publish a national drinking
water regulation requiring disinfection of ground water as necessary. The GWR sets conditions
where disinfection of ground water is considered necessary. The final GWR was promulgated
November 8, 2006. Burden will include the following:
•
•

•

•
•
•

Ground water systems providing 4-log treatment of viruses must begin
compliance monitoring to demonstrate treatment effectiveness.
Ground water systems for which the state has identified a significant deficiency
(during a sanitary survey) and systems that have confirmed fecal contamination of
their source waters must comply with the treatment technique requirements and
any associated reporting requirements.
Ground water systems that do not provide 4-log treatment of viruses must conduct
triggered source water monitoring if the system tests positive for total coliform in
the distribution system under the TCR.
Ground water systems will prepare for and participate in sanitary surveys.
States will conduct sanitary surveys of ground water systems.
States will track and file monitoring results and review any additional reporting
required.

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Microbial Rules ICR

2(b)

September 2008

Use/Users of the Data

The information described in Section 4 of this ICR will be collected by EPA and made
available to the public upon request, as required by the Freedom of Information Act (40 CFR
Chapter 1 Part 2). In some cases, SDWA requires that the information be provided to the public
or the primacy agency. Primary users of the data collected under this ICR are OGWDW, PWS
managers, and primacy agencies, which include State regulators, Indian Tribes, and, in some
instances, EPA Regional Administrators. Other users include the following—
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•

Staff from other EPA programs (such as Superfund, the Resource Conservation
and Recovery Act, and the Office of Enforcement and Compliance Assurance)
Federal Emergency Management Administration
Centers for Disease Control and Prevention (CDC)
Military bases
Farmers Home Administration
Department of Interior
Department of Housing and Urban Development
U.S. Army Corps of Engineers
White House Task Forces
American Water Works Association (AWWA)
Association of Metropolitan Water Agencies (AMWA)
National Rural Water Association (NRWA)
National Association of Water Companies (NAWC)
Association of State Drinking Water Administrators (ASDWA)
Natural Resources Defense Council
Consumers Federation of America
News organizations

Primacy agencies maintain records compiled from PWS respondents (§142.14) and can
use these records to track PWS monitoring, compliance violations, and enforcement activities.
The primacy agency can also track schedules for PWSs trying to achieve compliance. Primacy
agencies also report the number of violations, which will help them to target systems for
compliance and take the necessary remedial action.
Primacy agencies report information on PWS violations to SDWIS. This Federal
information system allows EPA and States to store and retrieve information over time. Trends in
compliance data can be evaluated at the system, State, and national program levels. Usually,
these data are used by the Agency for maintaining oversight and to support Federal enforcement
actions in cases where States fail to enforce.

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Microbial Rules ICR

September 2008

3
NON-DUPLICATION, CONSULTATIONS, AND OTHER
COLLECTION CRITERIA
3(a)

Non-duplication

EPA has made an effort to ensure that the data collection efforts associated with this ICR
are not duplicated. EPA consulted with State environmental programs, other Federal agencies
(such as the CDC), and regulated entities (such as PWSs and their representative trade
associations). To the best of EPA's knowledge, data currently required by the SDWA (and its
implementing regulations codified at 40 CFR Parts 141 and 142) are not available from any other
source.
3(b)

Public Notice Required Prior to ICR Submission to OMB

To comply with the 1995 Amendments to the PRA, EPA solicited public comment on
this ICR for a 60-day period before it was submitted to OMB. Specifically, EPA published a
notice in the Federal Register requesting comment on the estimated respondent burden and other
aspects of this ICR (Appendix A). EPA did not receive any comments during the 60-day
comment period.
3(c)

Consultations

Throughout the development and implementation of various microbial regulations,
OGWDW has held numerous meetings with interested stakeholders, including State and EPA
Regional personnel and PWS representatives, to identify the value and ease of collecting
information needed to fulfill SDWA obligations. As a standard regulatory development practice
to promote public involvement, EPA formally solicits public comment on proposed drinking
water rules. Before any rule is finalized, EPA logs and evaluates all written comments on
proposed rules. Additionally, EPA usually holds public meetings during which any interested
party may provide oral testimony for Agency consideration. Such meetings are typically
announced in the Federal Register (FR) notice accompanying the proposed rule.
In the initial phases of program development, or to confirm assumptions on which rules
or guidelines are based, EPA often augments formal meetings with other workshops or meetings
to gather information. The following are specific examples of meetings and other consultations
held by EPA to address the regulations contained in this ICR—
•
•

•
•

In 1985, EPA held a workshop to discuss options for regulating microbial
contaminants.
In 1985, the Federal Register presented a discussion on the need for mandatory
filtration and disinfection of surface water. This FR notice also requested public
comment on the subject.
A FR notice was published on May 6, 1988, to discuss additional alternatives for
the proposed SWTR.
The TCR was published on June 29, 1989. The 1989 TCR was reviewed as part
of the six-year review of drinking water standards. EPA published its preliminary
revise/do not revise decisions in the FR to request public comment (67 FR 1902919090). EPA received and reviewed comments from 44 commenters. EPA held a

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Microbial Rules ICR

•

•
•
•

•
•

September 2008

stakeholder meeting on May 30, 2002 to discuss the results of these preliminary
findings.
In 1992, EPA instituted a formal regulation negotiation (RegNeg) process to
discuss proposed amendments to the SDWA with potentially affected parties (57
FR 53866; Nov. 13, 1992). This RegNeg Committee included representatives
from water utilities and other industries, State public health and regulatory
agencies, environmental groups, consumer groups, and EPA. The RegNeg
Committee agreed that EPA should propose three rules: Information Collection
Rule (finalized in 1996), a staged Enhanced Surface Water Treatment Rule, and a
staged Disinfectants and Disinfection Byproducts Rule.
A microbial contaminants and disinfection byproducts advisory committee,
formed under the authority of the Federal Advisory Committees Act, convened in
1997 to review the data and assumptions used to support the 1994 proposed
changes to the SWTR and data that had subsequently been collected. In July
1997, participants signed an agreement in principle, outlining the Committee’s
recommendations to EPA on the major components of the IESWTR and Stage 1
DBPR.
Between March and December 1997, the Small System Data Needs Working
Group held six meetings to discuss availability of water quality and financial data
for small systems.
Twenty-four small entity representatives (SERs) were invited to participate in a
teleconference to discuss the FBRR and LT1ESWTR on April 28, 1998. Of the
24 invited SERs, 15 participated in the teleconference.
On August 21, 1998, a Small Business Advocacy Review Panel (SBARP) met to
discuss the proposed FBRR and LT1ESWTR. Two additional meetings of the
SBARP were held between August 21 and October 19, 1998.
In September 1998, the SBARP distributed information on regulatory approaches
and costs to the SERs for review and comment.
The SBARP and SERs participated in a joint teleconference on September 25,
1998.
A Stage 2 Microbial Disinfectants and Disinfection Byproducts (M-DBP)
Advisory Committee was formed under the authority of the Federal Advisory
Committees Act. The committee represented a broad cross section of
organizations and convened 14 times between March 1999 and February 2000.
EPA held 3 meetings with representatives of small entities and one meeting with
tribal representatives to discuss LT2ESWTR.
In December 1997, EPA held a preliminary meeting on the GWR. After the
initial meeting, five meetings were held throughout the country. Early
involvement meetings were also held with State regulators. EPA also received
input from small system operators.

As part of the revision of the Microbial Rules ICR, in early 2008 EPA consulted with
representatives of PWSs and States regarding the accuracy of EPA’s burden estimates. The
groups consulted were NAWC, NRWA, AWWA, AMWA, and ASDWA. NAWC deferred to
AMWA’s and AWWA’s comments, and NRWA did not submit any comments on the microbial
rules. AWWA submitted written comments but did not provide revised estimates. AMWA and
ASDWA both submitted revised burden estimates. EPA incorporated the input received into the
models that estimate the burden for each rule addressed in this ICR. The end of each appendix to
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Microbial Rules ICR

September 2008

the ICR contains a table summarizing EPA’s previous and revised burden estimates for the
relevant rule.
Since the regulations covered by this ICR are not new, the typical consultations,
workshops, and meetings held for proposed rules were not held immediately prior to the
development of this document.
3(d)

Effects of Less Frequent Collection

EPA has considered a wide range of alternatives for frequency of data collection. Where
possible, EPA has chosen to require the least frequent collection that remains consistent with
overall public health protection objectives. If data are collected less frequently, the primacy
agency may not identify in a timely fashion significant contaminant concentrations which might
threaten the health and safety of drinking water consumers.
For some microbial contaminant regulations, the primacy agency has discretion in
adjusting the monitoring schedules. Monitoring schedules vary based on the number of people
served by a system, contaminants likely to be found, and source of raw water supply. The
monitoring frequency design also considers that the number of people served affects exposure to
contaminants, as well as the resources available to undertake monitoring activity. Monitoring
frequencies have been carefully devised based on the following factors—
•
•
•
•
•
•

3(e)

Data quality needed for a representative sample.
Precision and accuracy needed from the representative sample.
Number of people served by the system.
Source of the supply (e.g., surface water or ground water).
Contaminants likely to be found.
Historical variability in contaminant occurrence.

General Guidelines

This ICR was prepared in accordance with the November 2005 ICR Handbook prepared
by EPA’s Office of Environmental Information, Office of Information Collection, Collection
Strategies Division. The ICR Handbook provides the most current instructions for ICR
preparation to ensure compliance with the 1995 PRA amendments and OMB’s implementing
guidelines.
3(f)

Confidentiality
No confidential information will be collected as a result of this ICR.

3(g)

Sensitive Questions
No information of a sensitive nature will be collected as a result of this ICR.

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Microbial Rules ICR

September 2008

RESPONDENTS AND INFORMATION REQUESTED

4(a)

Respondents/NAICS Codes

Data associated with this ICR are collected and maintained at the PWS, State, and
Federal levels. Respondents include—
•
•

Owners/operators of PWSs, who must report to the primacy agency.
Primacy agencies, which must report to EPA Headquarters.

The North American Industry Classification System (NAICS) code for PWSs is 22131.
The NAICS code for State agencies that include drinking water programs is 92411
(Administration of Air and Water Resources and Solid Waste Management Programs) or 92312
(Administration of Public Health Programs). Ancillary systems (i.e., those that supplement the
function of other establishments like factories, power plants, mobile home parks, etc.) cannot be
categorized in a single NAICS code. For ancillary systems, the NAICS code is that of the
primary establishment or industry.
4(b)

Information Requested

Exhibits 2 and 3 summarize the respondent information collection requirements covered
by the Microbial Rules ICR. These requirements are also discussed below.

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September 2008

Exhibit 2: PWS Recordkeeping and Reporting Requirements
Requirement
Regulatory Citation
General Requirements (apply to all regulations)
Reporting
Except where a different period is specified
in an individual drinking water regulation,
PWSs are required to submit the following
to the State:
Results of any test measurement or
analysis required in 40 CFR Part 141.
Failure to comply with any NPDWR.

40 CFR 141.31(a)
40 CFR 141.31(b) and
(c)

Frequency/Retention

At the end of the required
monitoring period
As necessary, unless State lab
performs analysis and reports
results to State
As requested by the State

Copies of records required to be
40 CFR 141.31(e)
maintained under 141.33 and/or copies of
documents that the State is entitled to
under Section 1445 of SDWA or State law.
Recordkeeping
Except where a different period is specified
in an individual drinking water regulation,
PWSs are required to retain the following
information:
Records of bacteriological or chemical
40 CFR 141.33(a)
5 years for bacteriological data;
analyses and related information.
10 years for chemical data
Records of actions taken by the PWS to
40 CFR 141.33(b)
3 years after last action taken
correct violations of NPDWRs.
related to the violation
Copies of any written reports, summaries,
40 CFR 141.33(c)
10 years
or communications relating to sanitary
surveys.
Records concerning a variance or
40 CFR 141.33(d)
5 years following the expiration of
exemption granted.
the variance or exemption
SWTR (all requirements except those regarding disinfection residual monitoring)
Unfiltered Systems – Reporting
Report source water quality information to
40 CFR 141.75(a)(1)(i) Monthly
the State for each month the system
through (ix)
serves water to the public.
Report to the State a summary of PWS
40 CFR 141.75(a)(3)
Annually
compliance with all watershed control
program requirements.
Report to the State on the on-site
40 CFR 141.75(a)(4)
Annually
inspection conducted during that year.
Any waterborne disease outbreak
40 CFR 141.75(a)(5)(i) As necessary, as soon as
potentially attributable to that water system
possible but not later than end of
must be reported to the State.
the next business day.
Any time turbidity exceeds 5 Nephelometric 40 CFR 141.75(a)(5)(ii) As necessary, as soon as
Turbidity Units (NTU) the PWS must inform
practical but no later than 24
the State.
hours after learning of the
exceedance.
Filtered Systems – Reporting
Report to the State turbidity measurements 40 CFR 141.75(b)(1)(i) Monthly
and associated information for each month through (iii)
the system serves water to the public.
Any time turbidity exceeds 5 NTU the PWS 40 CFR 141.75(b)(3)(ii) As necessary, as soon as
must inform the State.
practical but no later than 24
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Microbial Rules ICR

September 2008

Requirement

Regulatory Citation

Any waterborne disease outbreak
potentially attributable to that water system
must be reported to the State.
TCR
Reporting
Prepare written sample siting plan for State
review.
Notify the State if fecal coliforms or E. coli
are present.

40 CFR 141.75(b)(3)(i)

40 CFR 141.21(a)(1)

As necessary

40 CFR 141.21(e)(1)

As necessary, by end of the day
in which system receives results,
or if state office is closed, by end
of next business day.
As necessary, by end of next
business day.
As necessary, within 10 days
after discovering the violation.

Report to the State any exceedance of the
40 CFR 141.21(g)(1)
MCL for total coliforms.
Report to the State any failure to comply
40 CFR 141.21(g)(2)
with coliform monitoring requirements.
Recordkeeping
Subject to general requirements as listed above.
IESWTR
Disinfection profiling - Recordkeeping
A PWS must retain disinfection profile data 40 CFR 141.172(b)(6)
in graphic form, as a spreadsheet, or in
some other format acceptable to the State
for review as part of sanitary surveys
conducted by the State.
Disinfection benchmarking - Reporting
A PWS must submit information to the
40 CFR 141.172(c)(4)
State as part of the required consultation
process when making significant changes
to disinfection practices.
Filtration - Reporting
A PWS using alternative filtration
40 CFR 141.173(b)
technologies must demonstrate to the
State that the system achieves required
removal/inactivation.
A PWS must report combined filter effluent 40 CFR 141.175(a)(1)
turbidity levels for each month that the
through (3)
system serves water to the public.
A PWS must report that it has conducted
40 CFR 141.175(b)
individual filter turbidity monitoring for each
month that the system serves water to the
public.
If certain measurement thresholds are
40 CFR 141.175(b)(1)
exceeded, a PWS must report individual
through (4)
filter turbidity measurements for each
month that the system serves water to the
public.
Following certain exceedances, a PWS
40 CFR 141.175(b)(1)
must report to the State the reason for the
and (2)
exceedance or that is has produced a filter
profile.
Following certain exceedances, a PWS
40 CFR 141.175(b)(3)
must report to the State that it has
conducted a filter self-assessment.
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Frequency/Retention
hours after learning of the
exceedance.
As necessary, as soon as
possible but not later than end of
the next business day.

As necessary

Monthly

As necessary

Microbial Rules ICR

Requirement
Following certain exceedances, a PWS
must submit to the State a comprehensive
performance evaluation (CPE).
If certain measurement thresholds are
exceeded, systems must inform the State.
Filtration - Recordkeeping
Systems must maintain the results of
individual filter turbidity monitoring.
FBRR
Recordkeeping
Collect and retain on file the following
recycle flow information for review and
evaluation by the State: 1) Copy of the
recycle notification and information
previously submitted to the State; 2) List of
all recycle flows and the frequency with
which they are returned; 3) Average and
maximum backwash flow rate through the
filters and the average and maximum
duration of the filter backwash process in
minutes; 4) Typical filter run length and a
written summary of how filter run length is
determined; 5) The type of treatment
provided for the recycle flow; and 6) Data
on the physical dimensions of the
equalization and/or treatment units, typical
and maximum hydraulic loading rates, type
of treatment chemicals used and average
dose and frequency of use, and frequency
at which solids are removed, if applicable.
LT1ESWTR
Reporting
Report the total number and percentage of
combined filter effluent (CFE) turbidity
measurements that exceeded their 95th
percentile turbidity limit. Report the turbidity
levels for measurements that exceed their
maximum turbidity limit.
Systems must report that they have
conducted individual filter turbidity
monitoring. If a system exceeds 1.0 NTU
in two consecutive measurements the
system must include the filter number,
date, turbidity values, and reason for the
exceedance at the end of the month.
If a self-assessment is required, the system
must report the date that it was triggered
and the date that it was completed.
If a CPE is required, the system must
report that the CPE is required and the
date that it was triggered.
If a CPE is required, the system must
submit a copy of the completed CPE
report.
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September 2008

Regulatory Citation
40 CFR 141.175(b)(4)

Frequency/Retention
As necessary

40 CFR 141.175(c)(1)
and (2)

As necessary, as soon as
possible but no later than the end
of the next business day.

40 CFR 141.175(b)

3 years

40 CFR 141.76(d)(1)
through (6), 141.33

10 years

40 CFR 141.550141.553

Monthly

40 CFR 141.560141.564

Monthly

40 CFR 141.560141.564

As necessary.

40 CFR 141.560141.564

As necessary.

40 CFR 141.560141.564

As necessary within 120 days
after the CPE was triggered
16

Microbial Rules ICR

Requirement
Report a description of the proposed
change in disinfection, the system’s
disinfection profile for Giardia lamblia (and,
if necessary, viruses) and disinfection
benchmark, and an analysis of how the
proposed change will affect the current
levels of disinfection.
Recordkeeping
Records of CFE turbidity monitoring
measurements.
Records of individual filter turbidity
monitoring measurements.
Records of disinfection profiles (including
raw data and analysis).
Records of disinfection benchmarking
(including raw data and analysis).
LT2ESWTR
Reporting
Results of E. coli and Cryptosporidium (and
turbidity, if applicable) source water
monitoring
Bin classification (or mean Cryptosporidium
level for unfiltered systems)
Use of uncovered finished water reservoirs
and a schedule for covering or disinfecting
them.
Systems installing technology must
demonstrate compliance with technology
based criteria.
Systems changing disinfection practices
must develop a disinfection profile and
benchmark for Giardia and viruses
Sampling schedule

Recordkeeping
Records of sample results for
Cryptosporidium, E. coli and turbidity.
Systems changing technologies must
complete a disinfection profile for Giardia
and viruses.
Results of treatment monitoring associated
with microbial toolbox and with UCFWRs
Notification that systems will not conduct
source water monitoring due to having 5log treatment in place
GWR
Reporting
A PWS conducting compliance monitoring
must notify the State any time the system
fails to meet any State-specified
requirements including, but not limited to,
minimum residual disinfectant
concentration, membrane operating criteria
or membrane integrity, and alternative
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September 2008

Regulatory Citation
40 CFR 141.540141.544

Frequency/Retention
As necessary

40 CFR 141.550141.553
40 CFR 141.560141.564
40 CFR 141.530141.536
40 CFR 141.540141.544

At least 3 years

40 CFR 141.706(a)

Monthly while monitoring is
required

40 CFR 141.710(e)(1)(e)(2), 141.712
40 CFR 141.714(b)

6 months after source water
monitoring is complete
One time, by April 1, 2008.

40 CFR 141.715

Varies

40 CFR 141.708141.709

As necessary

40 CFR 141.702

Once prior to initial monitoring
and once during second round of
monitoring

40 CFR 141.706

At least 3 years

40 CFR 141.708

At least 3 years

40 CFR 141.722

At least 3 years

40 CFR 141.722

At least 3 years

40 CFR 141.405(a)

As soon as possible but no later
than the close of the next
business day.

At least 3 years
Indefinitely
Indefinitely

Microbial Rules ICR

Requirement
treatment operating criteria, if operation in
accordance with the criteria or
requirements is not restored within 4 hours.
After completing any corrective action, a
PWS must notify the State of completion of
the corrective action
If a PWS with a positive TCR sample does
not conduct source water monitoring, the
system must provide documentation to the
State that it met the State criteria for
avoiding monitoring.
Recordkeeping
Records of corrective actions
Reports of public notification
Documentation of records of decisions and
records of invalidation of fecal indicatorpositive ground water source samples.
For consecutive systems, documentation of
notification to the wholesale system(s) of
total-coliform positive samples that are not
invalidated
Records of the State-specified minimum
disinfectant residual
Records of the lowest daily residual
disinfectant concentration and records of
the date and duration of any failure to
maintain the State-prescribed minimum
residual disinfectant concentration for a
period of more than 4 hours
Records of State-specified compliance
requirements of membrane filtration and of
parameters specified by the State for
State-approved alternative treatment and
records of the date and duration of any
failure to meet the membrane operating,
membrane integrity, or alternative
treatment operating requirements for more
than 4 hours

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September 2008

Regulatory Citation

Frequency/Retention

40 CFR 141.405(a)

Within 30 days.

40 CFR 141.405(a)

Within 30 days

40 CFR 141.405(b)
40 CFR 141.405(b)
40 CFR 141.405(b)

At least 10 years
At least 3 years
At least 5 years

40 CFR 141.405(b)

At least 5 years

40 CFR 141.405(b)

At least 10 years

40 CFR 141.405(b)

At least 5 years

40 CFR 141.405(b)

At least 5 years

Microbial Rules ICR

September 2008

Exhibit 3
Primacy Agency Recordkeeping
and Reporting Requirements
Requirement

Regulatory Citation

Minimum Frequency/
Retention Period

General Requirements (apply to all regulations)
Reporting
Submit reports to the Administrator
40 CFR 142.15(a)(1) and
Quarterly
containing new violations by PWS and
(2)
new enforcement actions by States that
occurred during the previous quarter.
Recordkeeping
Maintain records of tests, measurements,
40 CFR 142.14(a)
Varies (not less than one year)
analyses, decisions, and determinations
performed on each PWS to determine
compliance with applicable provisions of
State primary drinking water regulations.
Retain files, which shall include for each
40 CFR 142.14(d)(2) and
12 years
PWS in the State reports of sanitary
(3)
surveys, records of any State approvals,
and records of any enforcement actions.
SWTR (all requirements except those regarding disinfection residual monitoring)
Reporting
A list identifying the name, PWS
40 CFR 142.15(c)(1)(i)(A)
As necessary
identification number and date of the
determination for each PWS that the State
has determined is not required to provide
filtration treatment.
A list identifying the name and PWS
40 CFR 142.15(c)(1)(i)(B)
As necessary
identification number of each PWS that
the State has determined has no means
of having a sample transported and
analyzed for heterotrophic plate count
(HPC) by a certified laboratory under the
requisite time and temperature conditions
and is providing adequate disinfection in
the distribution system.
Notification of any determination that a
40 CFR 142.15(c)(1)(ii)
As necessary within 60 days of
PWS is not required to provide filtration
the end of the calendar quarter
treatment.
Recordkeeping
Records of microbiological analyses.
40 CFR 142.14(a)(1)
1 year
Records of microbiological analyses of
40 CFR 142.14(a)(2)
1 year
repeat or special samples.
Records of turbidity measurements.
40 CFR 142.14(a)(3)
1 year
Records of decisions made on a system40 CFR 142.14(a)(4)(ii)
Varies
by-system and case-by-case basis under
provisions of part 141, subpart H, subpart
P, or subpart T must be made in writing
and kept at the State.

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Microbial Rules ICR

Requirement
Records of any decision to allow a PWS
to substitute a turbidity limit, sample at
alternate locations, use continuous
monitoring (for unfiltered systems), or
reduce sampling or reporting.
Records of any decision that a violation of
the total coliform MCL was not caused by
a deficiency in treatment of the source
water.
Records of any decision that total coliform
monitoring otherwise required because
the turbidity of the source water exceeds 1
NTU is not feasible, except that if such
decision allows a system to avoid
monitoring without receiving State
approval in each instance.
Records of any decision that a public
water system’s watershed control program
meets the requirements of 141.71(b)(2).
Records of any decision that an individual
is a qualified operator for a PWS using a
surface water source or a ground water
source under the direct influence of
surface water
Records of any decision that a party other
than the State is approved by the State to
conduct on-site inspections.
Records of any decision that an unfiltered
PWS has been identified as the source of
a waterborne disease outbreak, and, if
applicable, that it has been modified
sufficiently to prevent another such
occurrence. A copy of the decision must
be provided to the system.
Records of any decision that certain
interim disinfection requirements are
necessary for an unfiltered PWS for which
the State has determined that filtration is
necessary, and a list of those
requirements. A copy of the requirements
must be provided to the system.
Records of any decision that automatic
shut-off of delivery of water to the
distribution system of an unfiltered PWS
would cause an unreasonable risk to
health or interfere with fire protection.

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September 2008

Regulatory Citation
40 CFR
142.14(a)(4)(ii)(A)(1)
through (5),(7),(8)

Minimum Frequency/
Retention Period
40 years or until 1 year after the
decision is reversed or revised

40 CFR
142.14(a)(4)(ii)(B)(3)

One year after the decision is
made

40 CFR
142.14(a)(4)(ii)(B)(4)

One year after the decision is
made

40 CFR
142.14(a)(4)(ii)(C)(3)

Until the next decision is
available and filed

40 CFR
142.14(a)(4)(ii)(C)(4)

Until the qualification is
withdrawn

40 CFR
142.14(a)(4)(ii)(C)(5)

Until the decision is withdrawn

40 CFR
142.14(a)(4)(ii)(C)(6)

Until filtration treatment is
installed

40 CFR
142.14(a)(4)(ii)(C)(7)

Until filtration treatment is
installed

40 CFR
142.14(a)(4)(ii)(C)(8)

Until rescinded

Microbial Rules ICR

Requirement

September 2008

Regulatory Citation

Records of any decision that a PWS may
use alternative filtration technology
because they consistently achieve 99.9
percent removal and/or inactivation of
Giardia lamblia cysts and 99.99 percent
removal and/or inactivation of viruses. A
copy of the decision must be provided to
the PWS.
Records of any decision that a system
using a ground water source is under the
direct influence of surface water.
Records of any determination that a PWS
supplied by a surface water source or a
ground water source under the direct
influence of surface water is not required
to provide filtration treatment. A copy of
the determination must be provided to the
system.
Records of analysis for other than
microbiological contaminants (including
total coliform, fecal coliform, and
heterotrophic plate count), residual
disinfectant concentration, other
parameters necessary to determine
disinfection effectiveness.
Special Primacy Requirements
An application for approval of a State
program revision that adopts 40 CFR part
141, subpart H Filtration and Disinfection.
TCR
Reporting
Reports to the Administrator containing a
list of PWSs that the State is allowing to
monitor less frequently than once per
month for CWSs or less frequently than
once per quarter for Noncommunity Water
Systems (NCWSs).
Recordkeeping
Records of microbiological analyses.
Records of microbiological analyses of
repeat or special samples.

40 CFR
142.14(a)(4)(ii)(C)(11)

Records of any decision to waive the 24hour time limit for collecting repeat
samples after a total coliform-positive
routine sample.
Records of any decision to allow a system
to waive the requirement for five routine
samples the month following a total
coliform-positive sample.
Records of any decision to invalidate a
total coliform-positive sample.
Records of any decision to reduce the
total coliform monitoring frequency for
certain CWSs to less than once per
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Minimum Frequency/
Retention Period
Until the decision is reversed or
revised

40 CFR
142.14(a)(4)(ii)(C)(14)

40 years

40 CFR
142.14(a)(4)(ii)(C)(14)(iii)

40 years or until withdrawn,
whichever is earlier

40 CFR 142.14(a)(6)

12 years

40 CFR 142.16(b)

One time

40 CFR 142.15(c)(2)

One time; update as needed

40 CFR 142.14(a)(1)
40 CFR 142.14(a)(2)

1 year
1 year

40 CFR 142.14(a)(5)(i)(A)

5 years

40 CFR 142.14(a)(5)(i)(B)

5 years

40 CFR 142.14(a)(5)(i)(C)

5 years

40 CFR 142.14(a)(5)(ii)(A)

Retain in such a manner that a
system’s current status may be
determined
21

Microbial Rules ICR

Requirement

September 2008

Regulatory Citation

month. A copy of the reduced frequency
decision must be provided to the system.
Records of any decision to reduce the
40 CFR 142.14(a)(5)(ii)(B)
total coliform monitoring frequency for
certain NCWSs to less than once per
quarter. A copy of the reduced frequency
decision must be provided to the system.
Records of any decision to reduce the
40 CFR 142.14(a)(5)(ii)(C)
total coliform monitoring frequency for
certain NCWSs during any month the
system serves 1,000 persons or fewer. A
copy of the reduced frequency must be
provided to the system.
Records of any decision to waive the 2440 CFR 142.14(a)(5)(ii)(D)
hour limit for taking a total coliform sample
for PWSs that do not practice filtration in
accordance with part 141, subpart H, and
that measure a source water turbidity level
exceeding 1 NTU near the first service
connection.
Records of any decision that certain
40 CFR 142.14(a)(5)(ii)(E)
NCWSs may reduce the frequency of their
sanitary survey to less than once every
five years and what that frequency is. A
copy of the reduced frequency decision
must be provided to the system.
A list of agents other than the State, if
40 CFR 142.14(a)(5)(ii)(F)
any, approved by the State to conduct
sanitary surveys.
Records of any decision to allow a PWS
40 CFR 142.14(a)(5)(ii)(G)
to forgo fecal coliform or E. coli testing on
a total coliform-positive sample if that
system assumes that the total coliformpositive sample is fecal coliform-positive
or E. coli-positive.
IESWTR
Reporting
A list of subpart H systems that have had
40 CFR 142.15(c)(5)
a sanitary survey completed during the
previous year and an annual evaluation of
the State’s program for conducting
sanitary surveys.
Recordkeeping
Records of microbiological analyses.
40 CFR 142.14(a)(1)
Records of microbiological analyses of
40 CFR 142.14(a)(2)
repeat or special samples.
Records of turbidity measurements.
40 CFR 142.14(a)(3)
Records of decisions made on a system40 CFR 142.14(a)(4)(ii)
by-system and case-by-case basis under
provisions of part 141, subpart H, subpart
P, or subpart T.
Records of systems consulting with the
40 CFR 142.14(a)(7)(i)
State concerning a significant modification
to their disinfection practice (including the
status of the consultation).
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Minimum Frequency/
Retention Period

Retain in such a manner that a
system’s current status may be
determined

Retain in such a manner that a
system’s current status may be
determined
Retain in such a manner that a
system’s current status may be
determined

Annually

1 year
1 year
1 year
As necessary

As necessary

Microbial Rules ICR

Requirement

September 2008

Regulatory Citation

Records of decisions that a system using
40 CFR 142.14(a)(7)(ii)
alternative filtration technologies can
consistently achieve a 2-log (99 percent)
removal of Cryptosporidium oocysts, as
well as the required levels of removal
and/or inactivation of Giardia and viruses
for systems using alternative filtration
technologies.
Records of systems required to conduct a 40 CFR 142.14(a)(7)(iii)
filter self-assessment, CPE or composite
correction program (CCP).
FBRR
Reporting
Subject to general requirements as listed above.
Recordkeeping
Records of any decisions made to
40 CFR
approve alternate recycle locations
142.14(a)(4)(ii)(A)(9)
LT1ESWTR
Reporting
Subject to general requirements as listed above.
Recordkeeping
Records of turbidity measurements.
40 CFR 142.14(a)(3)
Records of disinfectant residual
40 CFR 142.14(a)(4)(i)
measurements and other parameters
necessary to document disinfection
effectiveness.
Records of decisions made on a system40 CFR 142.14(a)(4)(ii)
by-system and case-by-case basis under
provisions of part 141, subpart H, subpart
P, or subpart T.
Records of systems consulting with the
40 CFR 142.14(a)(7)(i)
State concerning a significant modification
to their disinfection practice (including the
status of the consultation).
Records of decisions that a system using
40 CFR 142.14(a)(7)(ii)
alternative filtration technologies can
consistently achieve a 2-log (99 percent)
removal of Cryptosporidium oocysts, as
well as the required levels of removal
and/or inactivation of Giardia and viruses
for systems using alternative filtration
technologies.
Records of those systems required to
40 CFR 142.14(a)(7)(iii)
conduct a filter self-assessment, CPE or
CCP.
LT2ESWTR
Reporting
The bin classification after the initial and
40 CFR 142.15(c)(6)
after the second round of source water
monitoring for each filtered system
Any change in treatment requirements for 40 CFR 142.15(c)(6)
these systems due to watershed
assessment during sanitary surveys
The determination of whether the mean
40 CFR 142.15(c)(6)
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Minimum Frequency/
Retention Period
As necessary, kept until decision
is reversed or revised.

As necessary

40 years or until 1 year after
decision is reversed or revised

Not less than one year
Not less than one year

As necessary

After each round of monitoring

As necessary
23

Microbial Rules ICR

Requirement

September 2008

Regulatory Citation

Cryptosporidium level is greater than 0.01
oocysts/L both after the initial and after
the second round of source water
monitoring for each unfiltered system
Recordkeeping
Results of Cryptosporidium and E. coli
40 CFR 142.14(a)(9)
source water monitoring
Bin classification after the first and second 40 CFR 142.14(a)(9)
round of monitoring
Any change in treatment requirements for 40 CFR 142.14(a)(9)
filtered systems due to watershed
assessment during sanitary surveys
The determination of whether the mean
40 CFR 142.14(a)(9)
Cryptosporidium level is greater than 0.01
oocysts/L after the initial and after the
second round of source water monitoring
for each unfiltered system
The treatment processes or control
40 CFR 142.14(a)(9)
measures that systems use to meet their
Cryptosporidium treatment requirements
A list of systems required to cover or treat 40 CFR 142.14(a)(9)
the effluent of an uncovered finished
water storage facility
GWR
Reporting
The month and year in which the most
40 CFR 142.15(c)(7)
recent sanitary survey was completed or,
for a State that used a phased review
process, the date the last element of the
applicable eight elements was evaluated
for each ground water system
The date the system completed the
40 CFR 142.15(c)(7)
corrective action
All ground water systems providing at
40 CFR 142.15(c)(7)
least 4-log treatment of viruses (using
inactivation, removal, or a State-approved
combination of 4-log virus inactivation and
removal) before or at the first customer for
any ground water source(s).
Recordkeeping
Records of written notices of significant
40 CFR 142.14(d)(17)
deficiencies
Records of corrective action plans,
40 CFR 142.14(d)(17)
schedule approvals, and State-specified
interim measures
Records of confirmations that a significant 40 CFR 142.14(d)(17)
deficiency has been corrected or the fecal
contamination in the ground water source
has been addressed
Records of State determinations and
40 CFR 142.14(d)(17)
records of ground water system’s
documentation for not conducting
triggered source water monitoring
Records of invalidations of fecal indicator- 40 CFR 142.14(d)(17)
positive ground water source samples
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Minimum Frequency/
Retention Period

As necessary
As necessary
As necessary

As necessary

As necessary
As necessary

At least 12 years
At least 12 years

At least 12 years

At least 12 years
24

Microbial Rules ICR

Requirement
Records of State approvals of source
water monitoring plans
Records of notices of the minimum
residual disinfections concentration (when
using chemical disinfection) needed to
achieve at least 4-log virus inactivation
before or at the first customer
Records of notices of the State-specified
monitoring and compliance requirements
(when using membrane filtration or
alternative treatment) needed to achieve
at least 4-log treatment of viruses (using
inactivation, removal, or a State-approved
combination of 4-log inactivation and
removal) before or at the first customer
Records of written notices from the
ground water system that it provides at
least 4-log treatment of viruses (using
inactivation, removal, or a State-approved
combination of 4-log virus inactivation and
removal) before or at the first customer for
each ground water source
Records of written determinations that the
ground water system may discontinue 4log treatment of viruses (using
inactivation, removal, or a State-approved
combination of 4-log inactivation and
removal)

September 2008

Regulatory Citation
40 CFR 142.14(d)(17)

Minimum Frequency/
Retention Period
At least 12 years

40 CFR 142.14(d)(17)

At least 12 years

40 CFR 142.14(d)(17)

At least 12 years

40 CFR 142.14(d)(17)

At least 12 years

40 CFR 142.14(d)(17)

At least 12 years

4(b)(i) Data Items
Surface Water Treatment Rule6

Provisions of the SWTR require the following data to be collected by PWSs—
•
•
•
•
•
•
•

Source water coliform data for unfiltered systems.
Turbidity data for filtered and unfiltered systems.
Residual disinfectant concentrations for filtered and unfiltered systems. (This
requirement is addressed under the DDBP/Chems/Rads ICR.)
Annual summaries of watershed control programs for unfiltered systems.
Annual reports summarizing the results of on-site inspections for unfiltered
systems.
A report to the primacy agency within 48 hours following attribution of any
waterborne disease outbreak in filtered and unfiltered systems.

Includes all rule components except disinfectant residual monitoring and associated activities, which are included
in the DDBP/Chem/Rads Rules ICR (see footnote 2 for more information). All remaining SWTR requirements are
included in this Microbial Rules ICR.

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Microbial Rules ICR

September 2008

In addition, primacy agencies must submit special reports as specified in
§142(15)(c). These reports include—
•
•
•
•

List of PWSs not required to provide filtration.
List of PWSs not required to analyze for HPC.
Notification of determination that a PWS is not required to provide
filtration.
Total Coliform Rule

The TCR requires PWSs to collect and report presence or absence of coliform bacteria
(as total coliform) in the distribution system and data on the presence or absence of E. coli or
fecal coliform. Primacy agencies must maintain results of sanitary surveys conducted under
TCR.
In addition, primacy agencies must submit special reports as specified in §142(15)(c) and
must maintain records as specified in §142(14)(a)(5). These reports include lists of PWSs that
have received permission for reduced monitoring or monitoring waivers and the effective dates
of these waivers.
3)

Interim Enhanced Surface Water Treatment Rule

EPA must balance the health risks from microbial organisms (such as Giardia lamblia
and Cryptosporidium) against risks from compounds formed during water disinfection. The
Interim Enhanced Surface Water Treatment Rule (IESWTR) and Stage 1 Disinfectants and
Disinfection Byproducts Rule (DBPR), which were promulgated concurrently, address complex
and interrelated drinking water issues. The IESWTR requires individual filter monitoring and
modifies the turbidity levels specified in the SWTR.
Under the IESWTR, PWSs must report the following—
•
•

•
•
•
•
•
•

List of PWSs not required to provide filtration.
The total number of combined filter effluent (CFE) turbidity measurements that
exceeded their 95th percentile turbidity limit and the number of measurements
that exceed their maximum turbidity limit.
That they have conducted individual filter turbidity monitoring, including the
dates, filter number, and turbidities of any measurements that exceed 1.0 NTU.
Reports of exceptions to turbidity performance for individual filters.
If a self-assessment is required, the system must report the date that it was
triggered and the date that it was completed.
If a comprehensive performance evaluation (CPE) is required, the system must
report that the CPE is required and the date that it was triggered.
If a CPE is required, the system must submit a copy of the completed CPE report.
When those systems that are required to develop a disinfection profile plan a
significant change in disinfection practice, they must submit the profile, along
with an analysis of how the proposed change will affect the current disinfection
benchmark to the State for review.

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Microbial Rules ICR

September 2008

The IESWTR requires PWSs to keep the following records—
•

Individual filter turbidity measurements.

The IESWTR (in §142.14) requires primacy agencies to maintain the following items—
•
•
•
•

•
•

Records of turbidity measurements for individual filters.
Records of disinfectant residual measurements and other parameters necessary to
document disinfection effectiveness.
A list of systems consulting with the State to modify their disinfection practices.
A record of State decisions regarding the use of alternative filtration technologies
that have demonstrated 99 percent removal of Cryptosporidium oocysts by
specific water systems.
Records of any other system-by-system and case-by-case decisions made by the
State under provisions of Section 141, subpart H or subpart P or subpart T.
Records of those systems required to perform filter self-assessments, CPEs, or
composite correction program (CCP).

Additionally, the primacy agency must report the following (per §142.15)—
•
•

Subpart H7 systems that have had a sanitary survey in the last year.
Evaluation of the State’s program for conducting sanitary surveys for all Subpart
H systems.
Filter Backwash Recycling Rule

Under the FBRR, PWSs should already have reported the following, but they must keep
records of the reported information on file—
•
•
•
•
•
•
•

Recycle notification, which includes plant schematic, recycle flow, and plant
flow.
List of all recycle flows and the frequency with which they are returned.
Average and maximum backwash flow rates through the filters.
Average and maximum duration of the filter backwash process.
Typical filter run length and a written summary of how filter run length is
determined.
Type of treatment provided for the recycle flow.
Data on the physical dimensions of the equalization and/or treatment units, typical
and maximum hydraulic loading rates, type of treatment chemicals used, average
dose of treatment chemicals, frequency of treatment chemical use, and frequency
at which solids are removed, if applicable.
Primacy agencies must maintain records of decisions regarding alternate recycle
locations at PWSs.

Subpart H systems include all PWSs using surface water or ground water under the direct influence of surface
water (GWUDI) as a source (40 CFR §141.2).
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27

Microbial Rules ICR

September 2008

Long Term 1 Enhanced Surface Water Treatment Rule

Under LT1ESWTR, PWSs must report the following—
•

•
•

•
•
•
•

•

The total number of CFE turbidity measurements that exceeded their 95th
percentile turbidity limit and the number of measurements that exceed their
maximum turbidity limit.
That they have conducted individual filter turbidity monitoring, including the
dates, filter number, and turbidities of any measurements that exceeded 1.0 NTU.
If a system exceeds 1.0 NTU in two consecutive measurements the system must
include the filter number, date, time, and reason for the exceedance at the end of
the month.
Reports of exceptions to turbidity performance for individual filters.
If a self-assessment is required, the system must report the date that it was
triggered and the date that it was completed.
If a CPE is required, the system must report that the CPE is required and the date
that it was triggered.
If a CPE is required, the system must submit a copy of the completed CPE report.
Results of optional monitoring that show total trihalomethane (TTHM) levels
<0.064 mg/L and haloacetic acid (HAA5) levels <0.048 mg/L (only if the system
wishes to forgo profiling) or report that disinfection profiling has begun.
A description of the proposed change in disinfection, the system’s disinfection
profile for Giardia lamblia (and, if necessary, viruses) and disinfection
benchmark, and an analysis of how the proposed change will affect the current
levels of disinfection.

The PWS recordkeeping requirements under the rule include—
•
•
•

Records of individual filter turbidity measurements.
Records of disinfection profiles.
Records of benchmarking.

Currently, States are subject to the general reporting requirements under 40 CFR, Section
142.15. There are no additional reporting requirements under this rule.
The additional State recordkeeping requirements under LT1ESWTR include—
•
•
•
•
•
•
•
•
•

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Microbial Rules ICR

•
•

September 2008

Records of those systems required to perform filter self-assessments, CPE, or
CCP.
Long Term 2 Enhanced Surface Water Treatment Rule

PWSs must submit the following information—
Sampling schedule, including sampling location(s) and planned dates for source water
sampling (for initial and second round monitoring).
For systems that filter and serve 10,000 or more (part of this activity occurred during the
previous ICR clearance period):
•

Monthly E. coli and Cryptosporidium monitoring results, to be taken over a period of
2 years, plus two matrix spike samples for Cryptosporidium.

•

Monthly turbidity monitoring results (sampled concurrently with Cryptosporidium
and E. coli).
For small systems (serving fewer than 10,000 people) that filter:

•

Biweekly E. coli monitoring results, to be taken over a period of 1 year. (Part of this
monitoring occurred during the previous ICR clearance period.)

•

If system exceeds the Cryptosporidium monitoring trigger based on E. coli
monitoring results, then 24 Cryptosporidium samples, plus two matrix spike samples
for Cryptosporidium.

For unfiltered systems, 24 Cryptosporidium samples over a period of 2 years for large
systems and 1 or 2 years for small systems, plus two matrix spike samples for Cryptosporidium
(some of this monitoring occurred during the previous ICR clearance period.)
For filtered systems, bin classifications must be reported to the State. All unfiltered
systems must report their mean Cryptosporidium levels to the State.
For systems with uncovered finished water reservoirs (UCFWRs), a schedule to cover the
reservoir or disinfect the reservoir effluent (this was completed in the previous ICR clearance
period).
PWSs of all sizes that propose to make a significant change to their disinfection practice
will complete disinfection profiles and benchmarks for Giardia lamblia and viruses and report
these, along with a description of the proposed change in disinfection practice and an analysis of
how the proposed change will affect the current level of disinfection (some of this burden will
occur outside the ICR clearance period).

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Microbial Rules ICR

September 2008

PWSs of all sizes that install new technology as a result of their bin classifications or
choose to disinfect the effluent from an UCFWR will be required to demonstrate compliance
with certain criteria for each technology. (This reporting will occur outside the ICR clearance
period).
PWSs must keep all monitoring data collected under the LT2ESWTR on file for 3 years.
These data must be available for review during sanitary surveys.
States will be required to maintain the following data—
•
•

Results of initial and reassessment source water monitoring for small systems
Initial bin classifications for each filtered system and mean Cryptosporidium level for
each unfiltered system
Records of toolbox treatment technologies that systems choose to meet their
treatment technique requirements, plus any changes in toolbox treatment
technologies, including all documentation necessary to demonstrate compliance with
required design and implementation criteria for receiving log credit for toolbox
options
Any changes to initial bin classifications based on watershed assessment during
sanitary surveys
Records of technologies employed by unfiltered systems to meet virus, Giardia, and
Cryptosporidium inactivation requirements
List of systems required to cover or treat effluent of an UCFWR

•

•
•
•

States must report the following to EPA—
•

Initial bin classification for each filtered system and any changes in bin
classifications. Mean Cryptosporidium level for each unfiltered system.
Any finding that a system is not meeting its required Cryptosporidium treatment
level.

•

Ground Water Rule

PWSs must report or provide the following additional information (40 CFR 141.405)(a)—
C

Failure to meet any State-specified requirements including minimum residual
disinfectant concentration, membrane operating criteria or membrane integrity, and
alternative treatment operating criteria, if operation in accordance with the criteria or
requirements is not restored within 4 hours.

Completion of corrective action (within 30 days of completion)

Documentation to the State within 30 days of a total coliform-positive sample that a
PWS met the State criteria that exempt the system from source water monitoring
requirements.

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Microbial Rules ICR

September 2008

PWSs must keep records of the following (40 CFR 141.405)(b)—
C
C
C
C
C

Documentation of corrective actions
Documentation of notice to the public
Documentation of records of decisions and records of invalidation of fecal indicatorpositive ground water source samples
For consecutive systems, documentation of notification to the wholesale system(s) of
total-coliform positive samples that are not invalidated
For systems, including wholesale systems, that are required to perform compliance
monitoring, the following additional requirements include:
o Records of the State-specified minimum disinfectant residual
o Records of the lowest daily residual disinfectant concentration and records of
the date and duration of any failure to maintain the State-prescribed minimum
residual disinfectant concentration for a period of more than 4 hours
o Records of State-specified compliance requirements of membrane filtration
and of parameters specified by the State for State-approved alternative
treatment and records of the date and duration of any failure to meet the
membrane operating, membrane integrity, or alternative treatment operating
requirements for more than 4 hours

For records kept by the States, the additional requirements include (40 CFR 142.14)(d)(17):
•
•
•
•
•
•
•

•

Records of written notices of significant deficiencies.
Records of corrective action plans, schedule approvals, and State-specified
interim measures.
Records of confirmations that a significant deficiency has been corrected or the
fecal contamination in the ground water source has been addressed.
Records of State determinations and records of ground water system’s
documentation for not conducting triggered source water monitoring.
Records of invalidations of fecal indicator-positive ground water source samples.
Records of State approvals of source water monitoring plans.
Records of notices of the minimum residual disinfections concentration (when
using chemical disinfection) needed to achieve at least 4-log virus inactivation
before or at the first customer.
Records of notices of the State-specified monitoring and compliance requirements
(when using membrane filtration or alternative treatment) needed to achieve at
least 4-log treatment of viruses (using inactivation, removal, or a State-approved
combination of 4-log inactivation and removal) before or at the first customer.
Records of written notices from the ground water system that it provides at least
4-log treatment of viruses (using inactivation, removal, or a State-approved
combination of 4-log virus inactivation and removal) before or at the first
customer for each ground water source.
Records of written determinations that the ground water system may discontinue
4-log treatment of viruses (using inactivation, removal, or a State-approved
combination of 4-log inactivation and removal).

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Microbial Rules ICR

September 2008

Additionally, the State must report the following (40 CFR 142.15):
•

•
•

The month and year in which the most recent sanitary survey was completed or,
for a State that used a phased review process, the date the last element of the
applicable eight elements was evaluated for each ground water system.
The date the system completed the corrective action.
All ground water systems providing at least 4-log treatment of viruses (using
inactivation, removal, or a State-approved combination of 4-log virus inactivation
and removal) before or at the first customer for any ground water source(s).

4(b)(ii) Respondent Activities
PWSs and primacy agencies must complete the activities described in the sections below.
Public Water Systems
In general, each PWS is involved in the following collection activities—
•
•
•
•

Gathering information.
Processing, compiling, and reviewing the information collected.
Submitting reports and other documents.
Recording and maintaining the information.

For this ICR, these activities are necessary to complete monitoring, reporting, and
recordkeeping requirements associated with microbial contaminant-related regulations.
1)

Surface Water Treatment Rule

Requirements for reporting under the SWTR are separated into those for systems that use
filtration treatment and those for systems that do not use filtration treatment. The reporting
requirements for these types of PWSs are summarized in the paragraphs below.
Unfiltered Systems
•
•
•

•

Monitor and report information on the results of source water monitoring for total
or fecal coliform and turbidity.
Submit this information each month that the system is in operation.
Summarize fecal or total coliform monitoring by including the number of total or
fecal coliform samples collected; the values obtained for each measurement; the
number of results less than 20/100 milliliters (ml) for fecal coliform or less than
100/100 ml for total coliform during the month; the cumulative number of fecal
or total coliform results obtained since the start of the six consecutive month
compliance period; and the percent of samples less than the respective
performance standard for the six-month compliance period.
Summarize turbidity information to include values obtained for each
measurement of CFE; the value and date of each measurement that exceeded five
NTUs; and when the system informed its customers to boil their water.

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Microbial Rules ICR

•

September 2008

Monitor and report disinfectant residual levels (this requirement is addressed
under the DBP/Chem/Rads ICR).

Filtered Systems
•

•

Monitor and report to the State on a monthly basis information regarding CFE
turbidity. Turbidity reporting requirements vary according to the filtration
technology used.
Monitor and report disinfectant residual levels (this requirement is addressed
under the DBP/Chem/Rads ICR).
Total Coliform Rule

PWSs must conduct the following activities to comply with the TCR—
•
•
•
•
•

Collect water samples at specified intervals, as defined in the Federal or State
regulations.
Collect monitoring data on the presence of total coliform bacteria in the
distribution system.
Collect data on the presence or absence of E. coli or fecal coliform, following a
positive routine total coliform sample.
Report laboratory results and violations to the State at frequencies required by
Federal and State regulations.
Interim Enhanced Surface Water Treatment Rule

The IESWTR only applies to systems serving at least 10,000 people using surface water
or GWUDI; these PWSs are required to do the following—
•
•
•
•
•

Conduct continuous monitoring of individual filter turbidity for each filter in the
system.
Report individual filter turbidity monitoring results to the State at frequencies
specified in the Federal regulations.
Report exceptions to the State in cases where the monitoring shows
exceedances of specific turbidity levels.
Perform a filter profile, filter assessment, or a CPE if warranted.
Provide a CPE report to the State if necessary.
Filter Backwash Recycling Rule

•

The rule requires all PWSs to collect and retain on file recycle
flow information for review and evaluation by the State beginning June 8, 2004
(40 CFR, Section 141.76(d)).

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Microbial Rules ICR

September 2008

Long Term 1 Enhanced Surface Water Treatment Rule

Under the LT1ESWTR, PWSs are required to do the following—
•
Conduct continuous monitoring of individual filter turbidity for each filter in the
system.
•
Record individual filter turbidimeter readings at the specified intervals.
•
Report individual filter turbidity monitoring results to the State at frequencies
specified in the Federal regulations.
•
Report exceptions to the primacy agency in cases where the monitoring shows
exceedances of specific turbidity levels.
•
Perform a filter profile, filter assessment, or a CPE if warranted.
•
Provide a CPE report to the State if necessary.
•
Develop a disinfection benchmark, if necessary.
•
Consult with the State before making significant changes to disinfection practices.
6)

Long Term 2 Enhanced Surface Water Treatment Rule

Under the LT2ESWTR systems are required to do the following—
•
Monitor source water for E. coli and Cryptosporidium and calculate a treatment
bin classification based on monitoring results (some systems completed
monitoring and bin classification during the previous ICR clearance period).
Filtered systems serving less than 10,000 people may monitor for E. coli as a
trigger instead. These systems will only sample for Cryptosporidium if their E.
coli results exceed certain levels.
•
Install additional treatment if monitoring results trigger a system into a bin
classification requiring additional treatment for Cryptosporidium and report on
compliance with the requirements for the treatment installed.
•
Prepare disinfection benchmarking reports for Giardia and viruses if disinfection
is changed.
•
Submit a plan for covering or disinfecting any UCFWRs (this activity was
completed during the previous ICR clearance period).
•
Keep all monitoring data on file for 3 years.
7)

Ground Water Rule
Under the GWR, systems are required to do the following—
•
Undergo a sanitary survey, compiling records and accompanying the State or third
party conducting the survey.
•
Conduct triggered source water monitoring if the system tests positive for total
coliform in the distribution system under TCR, for systems not providing 4-log
inactivation of viruses. Under triggered monitoring requirements (40 CFR
141.402 ) a system must collect at least one source water sample and have that
sample tested for a fecal indicator (E. coli, enterococci, or coliphage) specified by
the State. If a system detects the State-specified fecal indicator at its source, then
the system must take five additional samples within 24 hours unless the State
determines that corrective action must be taken immediately.

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Microbial Rules ICR

•
•

September 2008

Conduct source water assessment monitoring for fecal indicators if required to do
so by the state.
Comply with treatment technique requirements and any associated reporting
requirements if the State identifies a significant deficiency during a sanitary
survey or the system has confirmed fecal contamination of their source water.
Monitor disinfectant residual for compliance, for systems providing disinfection
to achieve 4-log inactivation of viruses.
Maintain records of GWR information listed in section 4(b)(i).

Primacy Agencies
In general, primacy agencies conduct the following activities with regard to reporting and
recordkeeping—
•
•
•
•
•
•
•

Maintain an inventory of PWSs.
Compile results of analyses of drinking water samples.
Analyze and review PWS data.
Make determinations concerning PWSs.
Track PWS compliance.
List systems not in compliance with drinking water standards.
Recordkeeping such as maintaining State approval of plans and specifications,
enforcement activities, and variances and exemptions (V&E) for each PWS.

By conducting these activities, primacy agencies are able to evaluate PWS performance
and to identify PWS needs and problem areas. They also identify enforcement targets and
systems requiring remedial action. In addition, States serve as respondents when reporting
compliance data to the Federal government. Some of these activities are covered in the PWSS
Program ICR as general primacy activities. Therefore, only microbial contaminant-specific
recordkeeping activities have been included in this Microbial Rules ICR.
1)

Surface Water Treatment Rule

The SWTR states that primacy agencies must conduct the following—
•
•
•
•

Collect and maintain information submitted by PWSs.
Record which systems using surface water are required to provide filtration and
which are not. These records must be kept indefinitely.
Submit a special report to the EPA Administrator listing PWSs that are not
required to filter.
Retain the results of microbiological contaminant analyses of source water
samples in the same manner as other microbiological contaminant analytical
results.

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Microbial Rules ICR

September 2008

Total Coliform Rule

Primacy agencies are required by the TCR to conduct the following activities—
•
•
•
•

Analyze monitoring results and identify systems not in compliance with either
MCLs (or performance criteria) or monitoring and reporting frequencies.
Provide in writing permission for reduced monitoring or monitoring waivers;
maintain for five years.
Submit to the EPA Administrator a special report that lists PWSs that have
received permission to reduce monitoring requirements.
Collect and maintain data regarding the results of sanitary surveys conducted
under the TCR.
Interim Enhanced Surface Water Treatment Rule

Primacy agencies are required to maintain records of State verification activities and each
determination made and to report to EPA in accordance with State reporting requirements. In
addition, primacy agencies ensure that PWSs are implementing IESWTR properly. To meet
these responsibilities, States are involved in the following additional activities—
•
•
•
•
•

Review individual filter turbidity monitoring data.
Conducting CPEs for PWSs.
Conducting sanitary surveys.
Consulting with PWSs on changes in disinfection practice.
Conducting follow-up inspections.
Filter Backwash Recycling Rule

For the FBRR, primacy agencies incur a recordkeeping requirement for maintaining data
submitted by conventional and direct filtration PWSs that recycle. Primacy agencies must also
maintain written approval for all PWSs with alternate recycle locations.
5)

Long Term 1 Enhanced Surface Water Treatment Rule

Primacy agencies have the responsibility for ensuring the implementation of the
LT1ESWTR (40 CFR, Section 142.16). EPA anticipates that States will be involved in the
following activities—
•
•
•
•

Consulting with PWSs on changes in disinfection practice.
Conducting CPEs for PWSs (if requested).
Conducting follow-up inspections.
Compliance tracking for turbidity

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Microbial Rules ICR

September 2008

Long Term 2 Enhanced Surface Water Treatment Rule

Primacy agencies have the responsibility for ensuring the implementation of the
LT2ESWTR. This will include the following activities—
•
•
•
•
•
•
•
•
•
•
•

Obtaining primacy (this activity was completed in the previous ICR clearance
period)
Maintaining and updating the data management system
Reviewing small system sampling schedules and sampling locations
Maintaining E. coli and Cryptosporidium monitoring data from small systems
Responding to systems’ inquiries
Reviewing and approving schedules for covering or treating UCFWRs
Reviewing and approving bin classifications
Reviewing disinfection profiles and benchmarks
Reviewing and, in some cases, approving processes to meet bin treatment
requirements
Reporting the information required in section 4(b)(i)
Keeping records of the information in section 4(b)(i)
Ground Water Rule

States will need to perform the following tasks:
•
•
•

Obtain primacy (this activity is assumed to have been completed during the
previous ICR clearance period)
Perform sanitary surveys, and reporting and recordkeeping requirements
associated with performing sanitary surveys
Tracking and filing monitoring results and reviewing any additional reporting

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Microbial Rules ICR

September 2008

5
INFORMATION COLLECTED -- AGENCY ACTIVITIES,
COLLECTION METHODOLOGY, AND INFORMATION
MANAGEMENT
5(a)

Agency Activities

As part of its supervisory responsibility, EPA maintains SDWIS and evaluates SDWIS
data to determine system compliance. Agency personnel also reformat, distribute, and store
these data for a number of uses, including responding to Congressional and public inquiries.
EPA also oversees its Regional and State programs, provides technical assistance, and develops
policies designed to ensure consistent program implementation. EPA officials serve as
respondents when testifying to Congress on the PWSS Program or in the courts for enforcement
actions.
Burden and costs for the activities are addressed in the PWSS Program ICR (OMB No.
2040-0090). Section 5(a) of the PWSS Program ICR contains additional detail regarding the
activities supported by the collection of SDWIS data described above.
In addition to these activities, the Agency will also assume the activities performed by the
State in those States and territories that do not have primacy. Specifically, the Agency will be
involved in the following activities related to microbial contaminant regulations—
•
•
•
•
•
•
•
•

Mobilization, planning, and implementation.
Training PWS and consultant staff.
Analyzing and reviewing PWS data.
Making determinations concerning PWSs.
Conducting CPEs and sanitary surveys.
Meeting with PWSs about changes in recycling practices.
Compliance tracking.
Recordkeeping.

Burden and costs for these activities are accounted for under the primacy agency burden
(see Section 6). EPA Regional offices also conduct general primacy activities in States and
territories that do not have primacy. This burden is addressed in the PWSS ICR and is included
in the general primacy burden for primacy agencies.

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September 2008

Exhibit 4
EPA Requirements
Requirement
Regulatory Citation
General Requirements (apply to all regulations)
For States and other entities for which the
40 CFR 142.14 and 142.15
Agency maintains primacy, the Agency must
maintain the records and perform the reporting
activities required of States. (This burden is
addressed under primacy agency burden.)
Review State request for approval of a program 40 CFR 142.12(d)(3)
revision and notify State of determination
regarding request.
SWTR
Publish a notice of any proposed
40 CFR 142.80(b)
comprehensive review of State decisions to
determine if PWSs must provide filtration.
Notify each State affected by the results of a
40 CFR 142.80(c)
comprehensive review.
Make the results of comprehensive reviews
40 CFR 142.80(c)
available to the public.
Notify the State if periodic reviews or other
40 CFR 142.81(a)
available information indicate that the State has
abused its discretion in applying the criteria for
avoiding filtration or that the State has failed to
prescribe compliance schedules for PWSs that
must provide filtration.
Notify the State that a public hearing will be held 40 CFR 142.81(b)
on the notice provisions.
Publish a notice of the public hearing in the
40 CFR 142.81(c)
Federal Register and in a newspaper of general
circulation in the involved State.
TCR
Subject to general requirements as listed above.
IESWTR
Subject to general requirements as listed above
FBRR
Subject to general requirements as listed above.
LT1ESWTR
Subject to general requirements as listed above.
Publish a notice of any proposed
40 CFR 142.80(b)
comprehensive review of State decisions to
determine if PWSs must provide filtration.
Notify each State affected by the results of a
40 CFR 142.80(c)
comprehensive review.
Make the results of comprehensive reviews
40 CFR 142.80(c)
available to the public.
Notify the State if periodic reviews or other
40 CFR 142.81(a)
available information indicate that the State has
abused its discretion in applying the criteria for
avoiding filtration or that the State has failed to
prescribe compliance schedules for PWSs that
must provide filtration.
Notify the State that a public hearing will be held 40 CFR 142.81(b)
on the notice provisions.
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Frequency
As necessary

One time, as
necessary

As necessary

As reviews are
completed
As reviews are
completed
As necessary

As necessary
As necessary

As necessary

As reviews are
completed
As reviews are
completed
As necessary

As necessary

Microbial Rules ICR

Requirement
Publish a notice of the public hearing in the
Federal Register and in a newspaper of general
circulation in the involved State.
LT2ESWTR
Subject to general requirements as listed above.
Approving laboratories
Collecting and managing sampling location
descriptions, sampling schedules, and
monitoring data submitted by medium and large
systems.
GWR
Subject to general requirements as listed above.

5(b)

September 2008

Regulatory Citation
40 CFR 142.81(c)

Frequency
As necessary

40 CFR 141.705
40 CFR 141.702(a),
141.703(f), 141.706(b)

As necessary
As necessary

Collection Methodology and Management

Primacy agencies must report data to EPA on a quarterly basis. These data include any
new data and revisions or corrections to existing data. This information is maintained in
SDWIS, which contains the following—
•
•
•
•

Inventory data for each PWS
Violations
Enforcement actions and some follow-up activity
Variances and exemptions

Primacy agencies transmit SDWIS data to EPA both manually and electronically. In the
District of Columbia, Wyoming, and Indian Lands (except for the Navajo Nation, which has
primacy), results of system samples are sent directly to the EPA Region. Virtually all SDWIS
data are reported electronically by the primacy agency.
SDWIS data support a number of rule implementation and program management
activities, which include the following—
•

Tracking the status of PWSs that are in significant non-compliance (SNC). This
information is provided to the Office of Enforcement and Compliance Assurance,
as part of the reporting for enforcement and compliance assurance priorities.
These data provide senior management with information on trends in drinking
water enforcement.

•

Supporting data verification. EPA Regions undertake an extensive review of
SDWIS data—the primary purposes of which is to assess the quality of data and
recommend any necessary changes in collection or reporting methodologies.

•

Promoting consistent national program implementation. The process of data
verification provides insights into the primacy agency’s interpretation of
regulations. Such information supports fair and consistent SDWA
implementation and enforcement.

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September 2008

All costs for rule-related data management activities are addressed in the PWSS Program
ICR (OMB No. 2040-0090). Section 5(b) of the PWSS Program ICR contains additional detail
regarding the activities supported by the collection of SDWIS data described above.
5(c)

Small Entity Flexibility

In developing this ICR, EPA considered the requirement of the Small Business
Regulatory Enforcement Fairness Act (SBREFA) to minimize the burden of information
collections on small entities. Small entities include “small businesses,” “small organizations”
and “small government jurisdictions.” These terms are defined below.8
•

A small business is any business that is independently owned and operated and
not dominant in its field as defined by the Small Business Administration
regulations under Section 3 of the Small Business Act.

•

A small organization is any non-profit enterprise that is independently owned and
operated and not dominant in its field.

•

A small governmental jurisdiction is the government of a city, county, town,
township, village, school district or special district that has a population of fewer
than 50,000. This definition may also include Indian Tribes.

The major requirement under SBREFA is a regulatory flexibility analysis (RFA) of all
rules that have a “significant economic impact on a substantial number of small entities.” Since
this ICR is not currently associated with new rules, it is not currently subject to the SBREFA.
Throughout the 1992–1993 negotiated rulemaking process for the Stage 1 DBPR and the
IESWTR and the July 1994 proposals for these rules, a small PWS was defined as a system
serving fewer than 10,000 people. This definition reflects the original 1979 standard for
TTHMs, which applied only to systems serving at least 10,000 people. The definition thus
recognizes that the baseline conditions from which systems serving fewer than 10,000 people
would approach disinfection byproduct control and simultaneous control of microbial pathogens
would be different than those for systems serving 10,000 or more people. Subsequent to the
1994 proposals, EPA defined a “small business” (for purposes of RFAs in drinking water
regulations) as a PWS serving 10,000 or fewer people. This definition is consistent with the
approach used herein and in the 1996 Congressional amendments to SDWA.
EPA has made significant efforts to minimize the burden for all respondents, particularly
for small entities. In setting both MCLs and monitoring requirements, EPA has been able to
minimize burden for small entities as detailed below.

These definitions were taken from §601 of the Regulatory Flexibility Act.
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Microbial Rules ICR

September 2008

Surface Water Treatment Rule

Only a small percentage of small systems use surface water supplies; therefore, this rule
does not have a significant economic impact on a substantial number of small entities. Since
system size is the key determinant of the monitoring frequency requirements of the SWTR,
systems serving fewer than 3,300 people will have the least stringent monitoring requirements.
EPA will allow a reduction in the frequency of turbidity monitoring from six samples per
day to one sample per day for systems using slow sand filtration treatment or other eligible
technologies. Systems serving fewer than 500 people may also reduce sampling to once per day
regardless of filtration type.
2)

Total Coliform Rule

The number of required coliform samples varies directly with system size. Specifically,
for (CWSs), the number of samples range from a minimum of one sample per month for systems
serving fewer than 1,000 people to 480 samples per month for those serving 3,960,001 or more
people. This requirement is codified at 40 CFR §141.21(a). Generally, quarterly monitoring
must be conducted at noncommunity water systems (NCWSs) using ground water only serving
1,000 or fewer people. As provided for in §141.21(a)(3)(i), however, the primacy agency may
reduce the quarterly monitoring frequency as a result of a sanitary survey.
3)

Interim Enhanced Surface Water Treatment Rule

Except for sanitary survey requirements, which are carried out by the primacy agency,
the IESWTR only applies to systems serving at least 10,000 people. Accordingly, the rule does
not have a significant impact on small entities.
4)

Filter Backwash Recycling Rule

The FBRR applies to both large and small systems. Therefore, the rule will have an
effect on small entities. Accordingly, as part of the economic analysis for the rule, EPA certified
that this rule would not have a significant impact on a substantial number of small systems. As a
result, an RFA was not required.
5)

Long Term 1 Enhanced Surface Water Treatment Rule

The LT1ESWTR applies only to subpart H systems serving less than 10,000 people. The
rule will, therefore, have an effect on small entities. After considering the economic impacts of
the rule on small entities, EPA certified that this action would not have a significant economic
impact on a substantial number of small entities. The Agency determined that less than one
percent of small entities will experience an impact of less than one percent of their annual
revenues or expenditures. No affected small governmental jurisdictions are expected to incur
annual costs exceeding three percent of their annual revenue. Accordingly, an RFA was not
required.

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Microbial Rules ICR

September 2008

Long Term 2 Enhanced Surface Water Treatment Rule

The LT2ESWTR allows small systems to monitor for E. coli instead of Cryptosporidium.
The analysis for E. coli is much less expensive than Cryptosporidium. Small systems are only
required to monitor for Cryptosporidium if E. coli concentrations are above a trigger value. In
addition, systems with at least 2 years worth of historical Cryptosporidium data may use that data
instead of performing new monitoring.
7)

Ground Water Rule

The GWR was developed in consultation with the Small Business Advocacy Review
Panel. Several of the panel’s recommendations were incorporated into the rule. These
recommendations include:
•
•

5(d)

Risk targeted approach – only those systems most at risk are required to monitor
or provide corrections.
Using coliform monitoring instead of more expensive viral monitoring – the rule
requires preliminary monitoring for coliform. Only if coliform monitoring is
positive is monitoring of other organisms required.

Collection Schedule

The collection schedules for each rule are summarized below. Additional information
may be obtained by consulting the individual rules for specific collection schedules.
Exhibit 5
Collection Schedule
Rule

Collection Commencement Year

SWTR

1991/1993 (depending on filtration status)

TCR

1991 – coliform monitoring
1994 – sanitary surveys for CWSs, 1999 for
NCWSs
2002 – turbidity monitoring
2002/2004 - sanitary surveys (depending on size
and source type)
2005 – turbidity monitoring
2004 – recordkeeping
2006 – Cryptosporidium and E. coli monitoring first
round (depends on system size; all sampling
completed by 2011)
2010 – disinfection profiling (depends on system
size)
2012 – reporting for compliance with new
technologies
2015 – second round of Cryptosporidium and E.
coli monitoring
2009 – sanitary survey, triggered monitoring,
corrective action plans, compliance monitoring

IESWTR

LT1ESWTR
FBRR
LT2ESWTR

GWR

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Microbial Rules ICR

September 2008

ESTIMATING BURDEN AND COST OF COLLECTION

This section estimates the burden and cost to PWSs and primacy agencies for complying
with drinking water information requirements associated with microbial contaminant
rulemakings. These include the following—
Surface Water Treatment Rule9
Total Coliform Rule
Interim Enhanced Surface Water Treatment Rule
Filter Backwash Recycling Rule
Long Term 1 Enhanced Surface Water Treatment Rule
Long Term 2 Enhanced Surface Water Treatment Rule
Ground Water Rule

1)
2)
3)
4)
5)
6)
7)

This ICR updates the annual burdens and costs associated with these rulemakings for the
three-year ICR period of late 2008 through 2011. This section also discusses the assumptions
used to estimate cost and burden and describes the change in annual burden, as compared with
the current OMB annual burden inventory.
EPA is committed to accurately characterizing the burden and costs of rules it
promulgates. Consequently, EPA has refined some of the assumptions for calculating the burden
and costs associated with implementing the drinking water regulations contained in this ICR. For
this update, many assumptions were revised based on program changes and well-documented
changes in some data. To provide a comparable basis on which to calculate the requirements
addressed by the Microbial Rules ICR, and to address inconsistencies, EPA applied uniform
assumptions to all rules. The categories of assumptions are listed below.
•

•
•
•

Labor rates—for PWSs, the $2006 labor rate of $17.87 was obtained from the
Bureau of Labor Statistics (BLS) and inflated to $2007 using the Employee Cost
Index (ECI). An overhead rate of 60 percent was applied, resulting in an hourly
rate of $30.72 (see Section 6(b)). For States, the $2006 labor rate of $24.92 was
obtained from the Bureau of Labor Statistics (BLS) and inflated to $2007 using
the Employee Cost Index (ECI). An overhead rate of 60 percent was applied,
resulting in an hourly rate of $42.80 (see Section 6(b)).
PWS inventory figures from the most recent frozen SDWIS database pull
(October 2007).
Number of entry points—data from the 2000 Community Water System Survey
(CWSS).
Number of plants—data from the 2000 CWSS.

In addition, EPA revised some of the estimates of burden for particular activities (e.g., sampling,
developing reports) to reflect consultations with representatives of PWSs and States (see section
3(c).

Includes all rule components except disinfectant residual monitoring and associated activities, which are included
in the DDBP/Chem/Rads Rules ICR (see footnotes 3 and 6 for more information).
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44

Microbial Rules ICR

6(a)

September 2008

Respondent Burden
6(a)(i) Burden to Public Water Systems

The annual PWS burden for late 2008 through late 2011 is estimated to be approximately
8.52 million hours. Exhibit 6 (after Section 6(b)) shows the breakdown of the annual burden
hours on a rule-specific basis. Wherever possible, activity-level burden assumptions were
carried forward from previous ICRs. However, if updated data were available (e.g., system
inventories), the most recent data were used in burden calculations. Appendices B through G
show the assumptions and detailed burden calculations for each rule. The following further
describes the bases for the burden estimates for each rule.
1)

Surface Water Treatment Rule

Activities associated with the SWTR account for 0.78 million annual burden hours per
year. The assumptions used to calculate the SWTR burden are based largely on assumptions
carried forward from the 2004 Microbial Rules ICR. This ICR includes burden estimates for all
components of the SWTR except disinfectant residual monitoring and associated activities,
which are included in the Disinfectants and Disinfection Byproducts, Chemical, and
Radionuclides (DDBP/Chem/Rads) Rule ICR. For unfiltered systems, burden estimates include
raw water sampling for coliform, on-site inspections, watershed management, and raw water
turbidity monitoring. The burden for filtered systems includes only finished water turbidity
monitoring. Section 6(f) describes the reasons for changes between the burden reported in the
2004 Microbial Rules ICR and this ICR. Detailed burden and cost calculations for the SWTR
are provided in Appendix B.
2)

Total Coliform Rule

Activities associated with the TCR account for a burden of 3.46 million hours per year.
The burden estimates include routine total coliform monitoring and repeat sampling for E. coli or
fecal coliform. The assumptions used to calculate the TCR burden are based largely on
assumptions carried forward from the 2004 Microbial Rules ICR. Section 6(f) describes the
reasons for changes between the burden reported in the 2004 Microbial Rules ICR and this ICR.
Appendix C summarizes the assumptions used to calculate the TCR burden and provides the
detailed burden and cost calculations.
3)

Interim Enhanced Surface Water Treatment Rule

Activities associated with IESWTR account for a burden of 3.88 million hours per year.
Included in this burden are combined and individual filter turbidity monitoring, turbidity
exceptions reporting, and conducting individual filter assessments (IFAs). The assumptions used
to calculate the IESWTR burden are based largely on the assumptions carried forward from the
2004 Microbial Rules ICR. Reasons for changes in burden between the 2004 Microbial Rules
ICR and this ICR are summarized in Section 6(f). Detailed information about assumptions,
burden, and calculations are provided in Appendix D.

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Microbial Rules ICR

September 2008

Filter Backwash Recycling Rule

No burden is estimated for PWSs for this rule. Currently, the rule requires PWSs to
maintain records on recycle flow. The burden associated with this recordkeeping is assumed to
be negligible.
5)

Long Term 1 Enhanced Surface Water Treatment Rule

Activities associated with the LT1ESWTR account for a burden of 0.16 million hours per
year. The burden estimates for PWSs include turbidity exceptions reporting and turbidity
monitoring. The assumptions used to calculate the LT1ESWTR burden are based largely on the
assumptions carried forward from the 2004 Microbial Rules ICR. Reasons for changes in burden
between the 2004 Microbial Rules ICR and this ICR are summarized in Section 6(f). Detailed
information about assumptions, burden, and calculations are provided in Appendix E.
6)

Long Term 2 Enhanced Surface Water Treatment Rule

Activities associated with the LT2ESWTR account for a burden of 0.066 million hours
per year. The burden estimates include monitoring for E. coli and/or Cryptosporidium for
medium and small systems (large systems have completed the initial round of monitoring). In
addition, the burden estimates for PWSs include calculation of a bin classification based on the
monitoring results. Not all systems will calculate bin classification during the period covered by
the revised ICR. PWS burden estimates also account for some of the burden associated with
developing disinfection profiles and benchmarks. Reporting and recordkeeping burden from
covering or providing further treatment to any uncovered finished water reservoirs is assumed to
have been completed during the previous ICR clearance period.
The stand-alone LT2ESWTR ICR expires October 31, 2008. Burden and costs associated
with the LT2ESWTR and incurred after October 2008 are incorporated into the Microbial Rules
ICR. Appendix F summarizes the assumptions used to calculate the LT2ESWTR burden and
provides the detailed burden and cost calculations.
7)

Ground Water Rule

Activities associated with the GWR account for a burden of 0.18 million hours per year.
For ground water systems providing 4-log treatment of viruses, the burden estimates include
compliance monitoring to demonstrate treatment effectiveness and associated reporting,
including reports of disinfection failure. In addition, burden estimates for developing corrective
action plans are included. For ground water systems that do not provide 4-log treatment of
viruses, PWS burden estimates also account for burden associated with conducting triggered
source water monitoring if the system tests positive for total coliform in the distribution system
under the TCR, including the burden for initially notifying the State that the system provides
disinfection. PWS burden also includes the burden associated with sanitary surveys.
The stand-alone GWR ICR expires October 31, 2009. Burden and costs associated with
the GWR and incurred after October 2009 are incorporated into the Microbial Rules ICR.
Appendix G summarizes the assumptions used to calculate the GWR burden and provides the
detailed burden and cost calculations.
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Microbial Rules ICR

September 2008

6(a)(ii) Burden to Primacy Agencies
The annual burden for primacy agencies for late 2008 through late 2011 is estimated to
be approximately 2.15 million hours. Exhibit 7 (at the end of Section 6(b)) shows the annual
burden hours on a rule-specific basis. Many other primacy agency activities, such as compliance
assurance and data management, cannot be divided among specific rules and are included in the
PWSS Program ICR as general primacy activities. The bases for burden estimates included in
this ICR are detailed below.
1)

Surface Water Treatment Rule

The annual State burden for the SWTR is expected to be 0.18 million hours. All of this
burden is associated with review of finished water turbidity monitoring results. Estimates for
primacy agency burden for the SWTR are based on assumptions carried forward from the 2004
Microbial Rules ICR. Detailed calculations for burden and cost are shown in Appendix B.
2)

Total Coliform Rule

For primacy agencies, the annual burden associated with the TCR is estimated to be
approximately 0.59 million hours. This reflects burden to monitor TCR-related activities such as
reviewing routine coliform reports, E. coli and fecal coliform reports, and additional routine
sampling reports. Additionally, sanitary survey burden for ground water systems for year 1 of
this ICR period is included here. Sanitary survey burden for years 2 and 3 is included under the
GWR (see App. G). Sanitary survey burden for surface water systems is included under
IESWTR. Estimates for primacy agency burden for the TCR are based on assumptions carried
forward from the 2004 Microbial Rules ICR. Appendix C shows detailed burden and cost
calculations.
3)

Interim Enhanced Surface Water Treatment Rule

Primacy agencies are expected to expend 0.90 million annual burden hours implementing
requirements of the IESWTR. The assumptions used to calculate the IESWTR burden are based
largely on assumptions carried forward from the 2004 Microbial Rules ICR. The burden
includes estimates for review of turbidity monitoring results and exceptions reports.
Additionally, States conduct CPEs and sanitary surveys for all surface water systems. Detailed
cost and burden calculations are included in Appendix D.
4)

Filter Backwash Recycling Rule

No burden is estimated for States for this rule. The burden associated with the
recordkeeping requirements in this rule is assumed to be negligible.

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Microbial Rules ICR

September 2008

Long Term 1 Enhanced Surface Water Treatment Rule

The annual State burden for the LT1ESWTR is expected to be 0.14 million hours. The
assumptions used to calculate the LT1ESWTR burden are based largely on assumptions carried
forward from 2004 Microbial Rules ICR. The burden includes estimates for compliance tracking
and recordkeeping of turbidity monitoring for small systems, and review of turbidity monitoring
and turbidity exceptions reports. Additionally, States conduct turbidity exceptions reporting,
which includes CPEs and annual exception reports for systems serving 10,000 people or fewer.
Detailed calculations for burden and cost are shown in Appendix E.
6)

Long Term 2 Enhanced Surface Water Treatment Rule

The annual State burden for the LT2ESWTR is expected to be 0.044 million hours. The
assumptions used to calculate the LT2ESWTR burden are based largely on assumptions carried
forward from the LT2ESWTR ICR. State burden includes reviewing monitoring results and
assisting with and reviewing bin classifications. States will also review disinfection profiles and
benchmarks for systems that significantly change their disinfection practices. States are assumed
to have already completed startup and reviewing documentation associated with covering or
treating UCFWRs.
The stand-alone LT2ESWTR ICR expires October 31, 2008. Burden and costs associated
with the LT2ESWTR and incurred after October 2008 are incorporated into the Microbial Rules
ICR. Appendix F summarizes the assumptions used to calculate the LT2ESWTR burden and
provides the detailed burden and cost calculations.
7)

Ground Water Rule

The annual State burden for the GWR is expected to be 0.29 million hours. The
assumptions used to calculate the GWR burden are based largely on assumptions carried forward
from the GWR ICR. The burden includes that associated with performing sanitary surveys, as
well as burden to review initial compliance monitoring notification and compliance monitoring
reports submitted by PWSs. In addition, States will ensure PWSs are complying with treatment
technique requirements and any associated reporting requirements. For ground water systems
that do not provide 4-log treatment of viruses, State burden estimates also account for review of
triggered source water monitoring results. Lastly, the burden includes administrative activities
such as recordkeeping, staff training, and technical assistance to PWSs.
The stand-alone GWR ICR expires October 31, 2009. Burden and costs associated with
the GWR and incurred after October 2009 are incorporated into the Microbial Rules ICR.
Appendix G summarizes the assumptions used to calculate the GWR burden and provides the
detailed burden and cost calculations.

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Microbial Rules ICR

6(b)

September 2008

Respondent Costs
6(b)(i) Cost to Public Water Systems

Exhibit 6 shows the annual costs for PWSs over the three-year ICR period. Annual costs
are estimated at approximately $462.1 million, which consists of $265.0 million in labor costs,
$110.6 million in Operation and Maintenance (O&M) costs, and $86.6 million in capital costs.
PWS labor costs are based on the number of burden hours times the average hourly wage
rate, including overhead. The average hourly wage rate is the rate quoted by the Bureau of
Labor Statistics for Standard Occupational Classification (SOC) Code 51-8031, “Local
Government—Water and Liquid Waste Treatment Plant and System Operators.” The quoted
rate was $17.87 in 2006 dollars (see http://stats.bls.gov). For consistency, this rate has been
inflated to December 2007 dollars using the Employment Cost Index. In addition, 60 percent
overhead was assumed, bringing the loaded, inflated rate to $30.72 in December 2007 dollars.
In addition to the labor costs, there are O&M costs associated with the SWTR, TCR,
IESWTR, LT1ESWTR, LT2ESWTR, and GWR. For the SWTR, these O&M costs reflect nonlabor costs associated with coliform analyses (unfiltered systems) and turbidity analyses
(unfiltered and filtered systems). Coliform analysis O&M costs are based on analysis costs as
listed in the proposed Aircraft Drinking Water Rule (proposed in fall 2007). Turbidity analysis
O&M costs are based on vendor quotes regarding calibration materials needed to perform
turbidity analyses. TCR O&M costs reflect non-labor costs associated with coliform and E. coli
analysis. IESWTR O&M costs reflect non-labor costs associated with turbidity analysis for
individual filters. For the IESWTR, turbidity analysis costs are based on O&M cost equations
for operating an integrated Supervisory Control and Data Acquisition (SCADA) system. These
cost equations are carried forward from the IESWTR Regulatory Impact Analysis (RIA).
LT1ESWTR O&M costs also reflect non-labor costs associated with turbidity analysis for
individual filters. LT2ESWTR O&M costs reflect non-labor costs associated with
Cryptosporidium and E. coli laboratory analysis. GWR O&M costs reflect non-labor costs
associated with compliance (disinfection) monitoring (maintenance costs, monthly reagents,
charts, and recorder pens).
The SWTR, IESWTR, and LT1ESWTR also include capital costs for turbidity
monitoring equipment. For these rules, capital costs are estimated based on vendor estimates and
costing equations for in-line and bench-top turbidimeters, or SCADA systems needed to comply
with turbidity monitoring requirements. Capital costs are annualized based on the replacement
period for turbidity analysis equipment (estimated to be 7 years). The GWR includes capital
costs for chlorine monitoring equipment (chlorine analyzer, power cord, and chart recorder).
Further detail on the O&M and capital costs for the SWTR, TCR, IESWTR,
LT1ESWTR, LT2ESWTR, and GWR can be found in Appendices B, C, D, E, F, and G
respectively.

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Microbial Rules ICR

September 2008

6(b)(ii) Cost to Primacy Agencies
Exhibit 7 shows that the annual costs to primacy agencies are estimated at approximately
$91.9 million in labor costs. The labor costs are based on the SOC Code 19-2041, “State
Government - Environmental Scientists and Specialists, Including Health,” an average full time
equivalent (FTE) cost of $89,024, including overhead, which equates to approximately $42.80
per hour.10
There are no O&M or capital costs for primacy agencies under this ICR.

According to the ICR Handbook, an employee works an average of 2,080 hours in one year.
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Microbial Rules ICR

September 2008

Exhibit 6
Annual PWS Burden and Cost
October 1, 2008 – September 30, 2011
Cost

Activity
SWTR
TCR
IESWTR
LT1ESWTR
LT2ESWTR
GWR

Annual Burden
Hours
776,724
3,464,341
3,875,847
162,290
66,406

Annual Labor
Cost ($K)

176,399
8,522,006

TOTAL

Annual O&M Cost Annual Capital Total Annual Cost
($K)
Cost ($K)
($K)

$23,859
$106,415
$119,055
$4,985
$2,078

$1,308
$77,457
$13,766
$3,270
$14,610

$549
N/A
$83,298
$2,629
N/A

$25,716
$183,872
$216,120
$10,885
$16,688

Annual Responses
5,343,860
973,454
3,417,506
4,018
83,756

$8,574
$264,967

$149
$110,561

$125
$86,602

$8,847
$462,129

274,772
10,097,366

Note: Detail may not add exactly to totals due to rounding.

Exhibit 7
Annual Primacy Agency Burden and Cost
October 1, 2008 – September 30, 2011
Cost

Activity
SWTR
TCR
IESWTR
LT1ESWTR
LT2ESWTR
GWR
TOTAL

Annual Burden
Hours
183,216
591,019
897,456
141,732
43,844

Annual Labor
Cost ($K)
$7,841
$25,295
$38,410
$6,066
$1,877

290,642
2,147,910

$12,427
$91,916

Annual
Annual O&M
Capital Cost Total Annual Cost
Cost ($K)
($K)
($K)
N/A
N/A
$7,841
N/A
N/A
$25,295
N/A
N/A
$38,410
N/A
N/A
$6,066
N/A
N/A
$1,877
N/A
N/A

N/A
N/A

Annual Responses
22,700
1,877,510
66,211
4,018
256

$12,427
$91,916

38,439
2,009,135

Note: Detail may not add exactly to totals due to rounding.

6(c)

Agency Burden and Costs

Burden and costs to the Federal government are incurred by EPA’s drinking water
program at Headquarters and EPA Regions to assist primacy agencies in implementing drinking
water regulations. EPA burden and costs for on-going general activities for all EPA drinking
water regulations (not just those listed in this ICR) are accounted for under the PWSS Program
ICR. Burden and costs included in the PWSS Program ICR cover all cross-cutting (non-rule
specific) regulatory activities associated with compliance tracking, regulatory enforcement, and
rule development activities. There are no rule-specific activities expected for EPA under any of
the rules covered by this ICR.
6(d)

Estimating Respondent Universe and Total Burden and Costs

Respondents for this ICR include PWSs and primacy agencies. This ICR estimates that
the number of PWS respondents is 155,693 existing PWSs. All PWSs are not necessarily subject
to each of the information collection requirements contained in this ICR. Each rule associated
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Microbial Rules ICR

September 2008

with this ICR identifies the types of PWSs that are subject to that particular requirement. The
numbers, by type of PWSs affected for each rule, are identified in the appendices.
In addition to the PWS respondents, this ICR assumes 57 primacy agencies (50 States
plus the District of Columbia, U.S. Territories, and Indian Nations)11. Therefore, the total
number of respondents is 155,750. The total costs and burden for these respondents are
summarized in Exhibits 6 and 7.
6(e)

Bottom Line Burden Hours and Costs

The bottom line burden hours and costs for this ICR are presented in Exhibit 8. The total
annual respondent burden associated with this ICR, which includes burden for PWSs and
primacy agencies, is estimated to be approximately 10.7 million hours. The corresponding total
annual respondent costs are estimated to be $554.0 million. The annual capital and O&M costs
are approximately $197.2 million.

For several of these entities, primacy activities are actually implemented by EPA Regional offices. However, as a
simplifying assumption, they are included with the States for respondent calculations under this ICR.
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52

Microbial Rules ICR

September 2008

Exhibit 8
Bottom Line Annual Burden and Cost
October 1, 2008 – September 30, 2011
Annual Number of Respondents

155,750
155,693

(=)
(+)

57
Total Annual Responses

12,106,501
10,097,366

(=)
(+)

2,009,135
Number of Responses per Respondent

(=)

12,106,501

(/)

Hours per Response

Annual O&M and Capital Cost ($K)1

Total Annual Respondent Cost ($K)

Total Annual Hours (resp. plus
Agency)
Total Annual Cost ($K) (resp. plus
Agency)

10,669,916
8,522,006
2,147,910
0.88
10,669,916
12,106,501
$197,162
$110,561
$86,602
$554,045
$462,129
$91,916

PWS responses (see Exhibit 6)
Primacy agency responses (see Exhibit 7)

77.7
155,750

Total Annual Respondent Hours

Existing PWSs
Primacy agencies

Total annual responses from above
Total number of respondents from above

(=)
(+)

PWS hours (see Exhibit 6)
Primacy agency hours (see Exhibit 7)

(=)
(/)
(=)
(+)
(=)
(+)

10,669,916
10,669,916
0

(=)
(+)

$554,045
$554,045
$0

(=)
(+)

Total annual respondent hours from above
Total annual responses from above
Total O&M costs (see Exhibit 6)
Total capital costs (see Exhibit 6)
For PWSs (see Exhibit 6)
For primacy agencies (see Exhibit 7)
Total annual respondent hours from above
Total EPA hours
Total annual respondent cost from above
Total EPA cost

Note: Detail may not add exactly to totals due to rounding.
1

No Primacy Agency capital or O&M costs are incurred, see Exhibit 7.

6(f)

Reasons for Change in Burden

This section presents the change in burden and explains the reasons for the change in
burden. The discussion is divided into two parts—
•

Section 6(f)(i) summarizes the burden adjustments made (by addition of new
Rules) since the 2004 Microbial Rules ICR (see Exhibit 10).

•

Section 6(f)(ii) summarizes burden adjustments to each Rule since the 2004
Microbial Rules ICR (see Exhibits 11 through 13).

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Microbial Rules ICR

September 2008

Exhibit 9 summarizes how each of these changes affects the overall burden inventory for
the Microbial Rules ICR.
Exhibit 9
Summary of Changes in Annual Burden
(Includes PWS and Primacy Agency Burden)
Type of Change

Burden Estimated in the 2004
Microbial Rules ICR
Restructuring Adjustments–see
Section 6(f)(i)
Other Adjustments to Burden–see
Section 6(f)(ii)

Burden (hours)

Running Total

8,624,865

526,559

9,151,424

1,518,492

10,669,916

Comment
This burden serves as the baseline for the 2008
Microbial Rules ICR.

Burden for LT2 and GWR is now included in
this ICR.
Burden for which EPA seeks approval in this
ICR.

Note: Detail may not add exactly to totals due to rounding.

6(f)(i) Restructuring Adjustments
Several restructuring adjustments have been made to consolidate the burden for each of
the regulations being incorporated into the Microbial Rules ICR. These adjustments are
discussed below and summarized in Exhibit 10.
•

Burden associated with the LT2ESWTR. The final LT2ESWTR was
promulgated January 5, 2006. The stand-alone LT2ESWTR ICR expires on
October 31, 2008. Burden and costs associated with the LT2ESWTR and
incurred after October 2008 are incorporated into the Microbial Rules ICR.

•

Burden associated with the GWR. The final GWR was promulgated November 8,
2006. The stand-alone GWR ICR expires on October 31, 2009. Burden and costs
associated with the GWR and incurred after October 2009 are incorporated into
the Microbial Rules ICR.

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Microbial Rules ICR

September 2008

Exhibit 10
Restructuring Adjustments to the Annual Burden
Inventory for the Microbial Rules ICR
(Includes PWS and Primacy Agency Burden)
Action

Annual Burden Hours

N/A

8,624,865

Brief Explanation
Inventory for the 2004 Microbial Rules ICR carried forward as the baseline for 2008
Microbial Rules ICR (includes PWS, State, and EPA burden). Current opening
inventory for the 2008 Microbial Rules ICR.

Add

141,295

This represents the current LT2 burden inventory. This inventory is being moved
from the LT2 ICR (OMB 2040-0266) into the 2008 Microbial Rules ICR.

Add
Total

385,264
9,151,424

This represents the current GWR burden inventory. This inventory is being moved
from the GWR ICR (OMB 2040-0271) into the 2008 Microbial Rules ICR.
Microbial Rules ICR inventory based on current burden inventories.

Note: Detail may not add exactly to totals due to rounding.

6(f)(ii) Other Burden Adjustments
Changes in calculated burden are a result of updating relevant baseline information for
each rule with the most current and accurate information available (e.g., PWS inventories) and
updating labor rates to $2007. Where appropriate, estimated violation, waiver, and other
associated rates have also been updated to reflect current information on rule compliance.
Burden also may have changed as a result of consultation with water industry representatives.
Lastly, burden may have changed due to changes in rule requirements. Exhibits 11 and 12
summarize reasons for these changes and quantify the changes by rule. Burden adjustments
associated with PWS activities resulted in a burden increase of 1,348,453 hours and are detailed
in Exhibit 11. Burden adjustments for primacy agencies result in an increase of 170,039 hours
per year, as shown in Exhibit 12.

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Microbial Rules ICR

September 2008

Exhibit 11
Adjustments to PWS Burden from Previous ICR Estimates

Activity

SWTR

Previous Annual
Burden Estimate
(hours) 2005 - 2007

327,924

2008 - 2011
Annual Burden
Esimate

776,724

TCR

2,336,629

3,464,341

IESWTR

3,885,791

3,875,847

Change in
Burden

Reason for Change in Burden
The change in burden is attributable to the use of updated system
inventories and labor rates, as well as the incorporation of burden
consultation results used to calculate burden for unfiltered systems to
conduct raw water coliform sampling, on-site inspections, watershed
448,800 management, and raw water turbidity monitoring.

The change in burden results from updated system inventories, labor rates,
incorporation of burden consultation results used to calculate burden for
systems to continue routine total coliform sampling and reporting, repeat
E. coli or fecal coliform sampling and reporting, and additional routine
sampling as necessary. Additionally, coliform violation rates used to
calculate repeat and additional monitoring burden have been updated based
1,127,712 on SDWIS data from the FY07Q03 frozen database.
The change in burden is attributable to the use of updated system
inventories and labor rates, as well as the incorporation of burden
consultation results used to calculate burden for turbidity monitoring (for
large systems), submitting monthly turbidity exception reports, and
conducting individual filter assessments if the filter has turbidity levels
(9,944) greater than 1.0 NTU.

586

LT1ESWTR

314,978

162,290

LT2ESWTR

47,401

66,406

Existing PWSs should have completed requirements associated with
changing the recycle return location no later than 2006. New PWSs will
design their plants to meet the return location requirements. The burden
(586) going forward is expected to be negligible.
The change in burden results from updated system inventories, labor rates,
and incorporation of burden consultation results used to calculate burden
for turbidity monitoring for small systems, turbidity exceptions reporting,
and the removal of disinfection benchmarking burden associated with
PWSs serving 500 or fewer people, as they have completed disinfection
(152,688) benchmarking.
This represents the current LT2 annual PWS burden estimate. This burden
is being moved from the LT2 ICR (OMB 2040-0266) into the 2008
Microbial Rules ICR. 2008 - 2011 burden estimate reflects changes in rule
19,005 requirements and incorporates burden consultation results.

260,244

176,399

This represents the current GWR annual PWS burden estimate. This
burden is being moved from the GWR ICR (OMB 2040-0271) into the
2008 Microbial Rules ICR. 2008 - 2011 burden estimate reflects changes
(83,845) in rule requirements and incorporates burden consultation results.

7,173,553

8,522,006

FBRR

GWR
TOTAL

1,348,453 Adjusted PWS Burden.

Note: Detail may not add exactly to total due to independent rounding.

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Microbial Rules ICR

September 2008

Exhibit 12
Adjustments to Primacy Agency Burden from Previous ICR Estimates

Activity

SWTR

TCR

IESWTR

Previous Annual Burden
Estimate (hours) 2005 2007

Change in
Burden

2008 - 2011 Annual
Burden Esimate

89,385

183,216

792,428

591,019

622,805

897,456

363

LT1ESWTR

253,976

141,732

LT2ESWTR

93,894

43,844

125,020
1,977,871

290,642
2,147,910

FBRR

GWR
TOTAL

Reason for Change in Burden
The change in burden is attributable to the use of updated system inventories and
labor rates, as well as the incorporation of burden consultation results used to
93,831 calculate primacy agency burden associated with the review of PWS data.
The change in burden results from updated system inventories, labor rates,
incorporation of burden consultation results used to calculate burden for primacy
agencies to review routine total coliform reports, repeat E. coli or fecal coliform
reports, and additional routine sampling reports. Additionally, violation rates have
been updated based on SDWIS data from the FY07Q03 frozen database. Sanitary
survey burden for years 2 and 3 is accounted for under the GWR, and is no longer
(201,409) included under TCR.
The change in burden is attributable to the use of updated system inventories and
labor rates, as well as the incorporation of burden consultation results used to
calculate burden for reviewing monitoring results from turbidity monitoring (for
large systems), reviewing monthly turbidity exception reports, reviewing individual
filter assessments, conducting comprehensive performance evaluations, and
274,651 conducting sanitary surveys.
States have completed the review and recordkeeping associated with the FBRR. The
(363) burden going forward is expected to be negligible.
The change in burden results from updated system inventories, labor rates, and
incorporation of burden consultation results used to calculate burden for the primacy
agency to oversee turbidity monitoring for small systems and turbidity exceptions
reporting. Primacy agency burden associated with disinfection benchmarking by
PWSs serving 500 or fewer people has been completed, and is therefore no longer
(112,244) included here.
This represents the current LT2 annual State burden estimate. This burden is being
moved from the LT2 ICR (OMB 2040-0266) into the 2008 Microbial Rules ICR.
2008 - 2011 burden estimate reflects changes in rule requirements and incorporates
(50,050) burden consultation results.
This represents the current GWR annual State burden estimate. This burden is being
moved from the GWR ICR (OMB 2040-0271) into the 2008 Microbial Rules ICR.
2008 - 2011 burden estimate reflects changes in rule requirements and incorporates
165,622 burden consultation results.
170,039 Adjusted Primacy Agency Burden

Note: Detail may not add exactly to totals due to rounding.

Exhibit 13 shows the effects of these adjustments on the bottom line burden. Adding
1,348,453 hours to account for adjustments to PWS burden and adding 170,039 hours to account
for adjustments to primacy agency burden yields 10,669,916 hours.

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Microbial Rules ICR

September 2008

Exhibit 13
Adjustments to Annual Burden Carried Forward from Previous ICR Estimates
(Includes PWS and Primacy Agency Burden)
Action

Annual Burden Hours

None

9,151,424

Brief Explanation
2004 Microbial Rules ICR inventory based on current burden inventories (see Exhibit
10).

Add

1,348,453

Adjustment to the PWS burden carried forward from previous ICRs (see Exhibit 11).

Add
Total

170,039
10,669,916

Adjustment to the primacy agency burden carried forward from previous ICRs (see
Exhibit 12).
Hours requested in 2008 Microbial Rules ICR (see Exhibit 9).

Note: Detail may not add exactly to totals due to rounding.

6(g)

Burden Statement

The public reporting burden for collections included in this ICR is detailed in Exhibit 13
above. The annual respondent burden is estimated to average approximately 10.67 million hours,
of which 8.52 million hours are attributable to PWSs and 2.15 million hours to primacy agencies
(numbers may not add due to rounding. These estimates include time for gathering information
as well as developing and maintaining records.
Burden means the total time, effort, or financial resources expended by people to
generate, maintain, retain, 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 request for information collection unless
it displays a currently valid OMB control number. The OMB control numbers for EPA’s
regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.
To comment on the Agency's need for this information, the accuracy of the provided
burden estimates, and any suggested methods for minimizing respondent burden, including the
use of automated collection techniques, EPA has established a public docket for this ICR under
Docket ID No. EPA-HQ-OW-2008-0438, which is available for public viewing at the Water
Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102, 1301 Constitution Ave.,
NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the room
is (202) 566-1744, and the telephone number for the Water Docket is (202) 566-2426. An
electronic version of the public docket is available through EPA Dockets (EDOCKET) at
http://www.epa.gov/edocket. Use EDOCKET to submit or view public comments, to access the
index listing of the contents of the public docket, and to access those documents in the public
docket that are available electronically. Once in the system, select “search,” then key in the
docket ID number identified above. Also, you can send comments to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington,
DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. (EPA-HQOW-2008-0438) and the OMB Control No. (2040-0205) in any correspondence.
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File Type	application/pdf
File Title	Microsoft Word - MicrobialsICR_Septv2.doc
Author	mnataraja
File Modified	2008-11-10
File Created	2008-09-17