                        SUPPORTING STATEMENT FOR EPA's
                     INFORMATION COLLECTION REQUEST (ICR)
PFAS NATIONAL PRIMARY DRINKING WATER REGULATION UNDER THE SAFE DRINKING WATER ACT

                                  Prepared by

                        Environmental Protection Agency
                   Office of Groundwater and Drinking Water
                               Washington, D.C.

                           Draft for Public Comment
                                  March 2023

            SUPPORTING STATEMENT FOR THE COLLECTION OF INFORMATION
         FOR EPA's PFAS NATIONAL PRIMARY DRINKING WATER REGULATION

EPA ICR No. 2732.01
ICR OMB Control No. 2040-NEW
ICR Title: Implementation of EPA's PFAS National Primary Drinking Water Regulation

Introduction
This document supports EPA's compliance with requirements of the Paperwork Reduction Act for the implementation of EPA's PFAS National Primary Drinking Water Regulation (NPDWR). The purposes of the Paperwork Reduction Act of 1980 (PRA) (P. L. 96-511) and implementing regulations (44 U.S.C. Chapter 35) are to: 1) minimize the federal paperwork burden for small businesses, state and local governments, and other individuals; 2) minimize the Federal government's cost of collecting, maintaining, using, and disseminating information; and 3) maximize the usefulness of information collected by federal agencies.
This Information Collection Request (ICR), "PFAS National Primary Drinking Water Regulation," is made by EPA's Office of Groundwater and Drinking Water in the Office of Water, EPA Headquarters. The proposed information collection activities are accomplished by the least burdensome and least costly means and are not duplicated by other sources.
EPA administers the Safe Drinking Water Act (SDWA), as amended. SDWA was originally passed by Congress in 1974 to protect public health by regulating the nation's public drinking water supply. The law was amended in 1986 and 1996 and requires many actions to protect drinking water and its sources -- rivers, lakes, reservoirs, springs, and ground water wells. (SDWA does not regulate private wells which serve fewer than 25 individuals.) SDWA authorizes the United States Environmental Protection Agency (US EPA) to set national health-based standards for drinking water to protect against both naturally-occurring and man-made contaminants that may be found in drinking water. US EPA, states, and water systems then work together to make sure that these standards are met. The collections of information described in this document derive from EPA's authorities under and responsibilities in implementing SDWA.
The monitoring information collected as a result of the proposed rule should allow primacy agencies and EPA to determine appropriate requirements for specific systems and evaluate compliance with the proposed rule. For the first three-year period following rule promulgation, the major information requirements concern primacy agency activities to implement the rule including adopting the NPDWR into state regulations, providing training to state and PWS employees, updating their monitoring data systems, and reviewing system monitoring data and other requests. Compliance actions for drinking water systems (including monitoring, administration, and treatment costs) would not begin until after three years due to the proposed effective date of this rule.

Organization of Information Collection Request Statement
This document follows the format for ICR outlined in the Information Collection Review Handbook (Office of Management and Budget, 1989) and the Instructions for Standard Form 83 (revised version dated September 1983). No exceptions to this format are taken. EPA's Information Resources Management Policy Manual (July 1987), Regulation Development in EPA (September 1992), and EPA's Instructions for Preparing Information Collection Requests (June 1992) also guided the development of this document.

Supporting Statement
  Part A.  Part A of the supporting statement provides a detailed discussion of the need, use, costs, and methodology of the information collection.  Part A is organized into the following subsections:
Table of Contents
I.	Identification of the Information Collection	3
A.	Title of the Information Collection	3
B.	Short Characterization/Abstract	3
II.	Need for and use of the Collection	4
A.	Need/Authority for the Collection	4
B.	Practical Utility/Users of the Data	6
III.	Non duplication, Consultations, and Other Collection Criteria	7
A.	Non duplication	7
B.	Public Notice Required Prior to ICR submission to OMB	7
C.	Consultations	8
D.	Effects of Less Frequent Collection	14
E.	General Guidelines	16
F.	Confidentiality	17
G.	Sensitive Questions	17
IV.	The Respondents and the Information Requested	17
A.	Respondents/SIC Codes	17
B.	Information Requested	18
V.	The Information Collected - Agency Activities, Collection Methodology, and Information Management	20
A.	Agency Activities	20
B.	Collection Methodology and Management	21
C.	Small Entity Flexibility	21
D.	Collection Schedule	22
VI.	Estimating the Burden and Cost of the Collection	24
A.	Estimating Respondent Burden	25
B.	Estimating Agency Burden and Cost	33
C.      Estimating the Total Respondent Universe and Total Burden and Costs	34
D.	Bottom Line Burden Hours and Cost Tables	35
E.	Reasons for Change in Burden	37
F.	Burden Statement	37
APPENDIX A: SDWA Sections that Provide Authority for the Collection	40

Identification of the Information Collection
Title of the Information Collection
TITLE: Information Collection Request for the Proposed PFAS National Primary Drinking Water Regulation
EPA ICR Number: 2732.01
OMB Control Number: 2040-AG18
Short Characterization/Abstract
EPA is proposing Maximum Contaminant Level Goals (MCLGs) for perfluorooctanesulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) at zero and the enforceable Maximum Contaminant Level (MCL) at 0.0000040 mg/L or 4.0 parts per trillion (ppt) for each of these contaminants. Additionally, EPA is requesting public comment on preliminary positive regulatory determinations for hexafluoropropoylene oxide dimer acid (HFPO-DA) and its ammonium salt (also known as "GenX Chemicals"), perfluorobutane sulfonic acid (PFBS), perfluorononanoic acid (PFNA) and perfluorohexane sulfonic acid (PFHxS) and is proposing to regulate these additional per- and polyfluoroalkyl substances (PFAS) compounds through a Hazard Index (HI) approach. EPA is proposing to set the MCLG as a HI of 1.0 (unitless) and the enforceable MCL equal to the MCLG.
Water systems include federal, state, tribal, and local governmental entities as well as private entities. States (and tribes) that have been granted primary enforcement authority (i.e., primacy) for the enforcement of National Primary Drinking Water Regulations (NPDWRs) are responsible for overseeing rule implementation by systems within their jurisdiction. In instances where a state or tribe does not have primacy, EPA Region is the primacy agency. Systems demonstrate compliance through reporting the analytical results of collected samples and other information to the state. Systems use these data to demonstrate compliance, assess treatment options, operate and maintain installed treatment, and communicate water quality information to consumers served by the system. Primacy agencies utilize the data to determine compliance and designate treatment to be installed and enforceable operating parameters.
Under the Safe Drinking Water Act (SDWA), new regulations generally become effective three years after promulgation. The burden and cost estimates represent those activities that EPA expects would occur in this initial three-year period. During this period, systems and primacy agencies would perform the initial, one-time activities related to rule review and primacy requirements and conduct initial compliance activities related to the proposed PFAS NPDWR. Because several implementation activities do not begin during the initial three-year period, this Information Collection Request (ICR) does not include burden and costs for activities that are required during full rule implementation.

Need for and use of the Collection
 Need/Authority for the Collection
Section 1412(b)(1)(A) of the Safe Drinking Water Act (SDWA) requires EPA to establish NPDWRs for a contaminant where the Administrator determines that the contaminant: (1) may have an adverse effect on the health of persons; (2) is known to occur or there is a substantial likelihood that the contaminant will occur in public water systems (PWSs) with a frequency and at levels of public health concern; and (3) where in the sole judgment of the Administrator, regulation of such contaminant presents a meaningful opportunity for health risk reduction for persons served by PWSs.
EPA needs comprehensive and current information on PFAS occurrence to ensure any promulgated PFAS regulation mitigates risk of harmful exposure to PFAS in drinking water. Data collected in this ICR may also help to inform potential future updates and changes to this PFAS NPDWR, if appropriate.
For such regulations, Section 1401(1)(D) of SDWA requires that "criteria and procedures to assure a supply of drinking water which dependably complies with such maximum contaminant levels [or treatment techniques promulgated in lieu of a maximum contaminant level]; including accepted methods for quality control and testing procedures to insure compliance with such levels and to insure proper operation and maintenance of the system..." Furthermore, Section 1445(a)(1)(A) of SDWA requires that "[e]very person who is subject to any requirement of this subchapter or who is a grantee, 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 the Administrator in establishing regulations under this subchapter, in determining whether such person has acted or is acting in compliance with this subchapter..." In addition, Section 1413(a)(3) of SDWA requires primacy agencies to "keep such records and make such reports...as the Administrator may require by regulation."
The sections from SDWA 1996 Amendments, discussed above, are included as Appendix A to this document.
Practical Utility/Users of the Data
Primary users of the data collected under this ICR are water systems and their customers,  primacy agencies, and EPA. The information collected by EPA is available to the public,    via EPA's website (https://www.epa.gov/ground-water-and-drinking-water/safe-drinking-water-information-system-sdwis-federal-reporting) or by requesting the data under the Freedom of Information Act (FOIA; 40 CFR, Chapter 1, Part 2). Other organizations and individuals that may utilize the data include the following:
 Individual consumers, realtors, potential homebuyers, homeowners, households, and other members of the public
 News organizations
 Staff from other EPA programs (such as Superfund, the Resource Conservation and Recovery Act (RCRA), and the Office of Enforcement and Compliance Assurance (OECA))
 The Federal Emergency Management Administration (FEMA)
 Centers for Disease Control and Prevention (CDC)
 Military bases
 Farmers Home Administration (FmHA)
 Department of Interior
 Department of Housing and Urban Development (HUD)
 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)
 Environmental Council of the States (ECOS)
 Natural Resources Defense Council (NRDC)
 Rural Community Assistance Partnership (RCAP)
 Consumers Federation of America (CFA).

Non duplication, Consultations, and Other Collection Criteria
 Non duplication
EPA has consulted with other federal agencies, state agencies, small business entities (i.e., operators of small PWSs), PWSs, and tribal organizations to ensure non-duplication of this information collection. To the best of the Agency's knowledge, data required under this ICR for this proposed PFAS NPDWR are not available from any other source.
Public Notice Required Prior to ICR submission to OMB
To comply with the 1995 Amendments to the Paperwork Reduction Act (PRA), the Agency will     solicit public comment on this draft ICR during a 30-day public comment period coinciding with the comment period for the proposed rule. In the Federal Register notice for the proposed rule, EPA will request comment on the estimated respondent burden and other aspects of this information collection. Comments received will be considered by the Agency and used to adjust the burden and costs estimates presented in the final ICR prior to submission to the Office of Management and Budget (OMB).
Consultations
To help shape the development of the proposed PFAS NPDWR, EPA engaged with multiple stakeholders representing a wide range of expertise. The sections below describe these stakeholder engagement activities for the proposed NPDWR. Summaries from these stakeholder engagements and consultations are available in the docket for the proposed rule under EPA-HQ-OW-2022-0114 at https://www.regulations.gov. These consultations and engagements include:
Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations
Consistent with the Agency's Technical Guidance for Assessing Environmental Justice in Regulatory Analysis ( https://www.epa.gov/environmentaljustice/technical-guidance-assessing-environmental-justice-regulatory-analysis, EPA conducted an environmental justice (EJ) analysis to assess the demographic distribution of baseline PFAS drinking water exposure and impacts anticipated to result from the proposed PFAS NPDWR. EPA believes that the proposed rule does not have disproportionately high and adverse human health or environmental effects on minority populations, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The proposed rule is anticipated to increase the level of public health protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority population.
Additionally, on March 2, 2022, and April 5, 2022, EPA held public stakeholder meetings related to EJ and the development of the proposed NPDWR. The meetings provided an opportunity for EPA to share information and for communities to offer input on EJ considerations related to the development of the proposed rule. During the meeting and in subsequent written comments EPA received public comment on topics including establishing an MCL for PFAS, affordability of PFAS abatement options, limiting industrial discharge of PFAS, and EPA's relationship with community groups. For more information on the EJ stakeholder meetings, please refer to the Environmental Justice Considerations for the Development of the Proposed PFAS Drinking Water Regulation Public Meeting Summary for each of the meeting dates in the public docket at https://www.regulations.gov/docket/EPA-HQ-OW-2022-0114. Additionally, the written public comments are included within the public docket.
Regulatory Flexibility Act
Under section 609(b) of the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), EPA convened a Small Business Advocacy Review (SBAR) Panel to obtain advice and recommendations from small entity representatives (SERs) that potentially would be subject to the rule's requirements. On May 24, 2022, EPA's Small Business Advocacy Chairperson convened the Panel, which consisted of the Chairperson, the Director of the Standards and Risk Management Division within EPA's Office of Ground Water and Drinking Water, the Administrator of the Office of Information and Regulatory Affairs within OMB, and the Chief Counsel for Advocacy of the Small Business Administration (SBA). Prior to convening the Panel, EPA conducted outreach with SERs that will potentially be affected by this regulation and solicited comments from them. Additionally, after the Panel was convened, the Panel provided additional information to the SERs and requested their input. In light of the SERs' comments, the Panel considered the regulatory flexibility issues and elements of the initial regulatory flexibility analysis (IRFA) specified by RFA/SBREFA and developed the findings and discussion summarized in the SBAR report. The report was finalized on August 1, 2022 and transmitted to EPA Administrator for consideration. A copy of the full SBAR Panel report is available in the rulemaking docket. Additional details on small entity flexibilities can be found in the rulemaking docket.
Unfunded Mandates Reform Act
This action contains a Federal mandate under Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538 that may result in expenditures of $100 million or more for state, local, and tribal governments, in the aggregate, or the private sector in any one year. Accordingly, EPA has prepared a written statement required under section 202 of UMRA. The statement is included in the docket for this action (see Chapter 9 of the Economic Analysis for the Proposed PFAS NPDWR).
Consistent with the intergovernmental consultation provisions of UMRA section 204, EPA consulted with governmental entities affected by this rule. EPA describes the government-to-government dialogue and comments from state, local, and tribal governments in section XV.E Executive Order 13132: Federalism and section XV.F Executive Order 13175: Consultation and Coordination with Indian Tribal Governments of the Federal Register Notice for this rulemaking action.Consistent with UMRA section 205, EPA identified and analyzed a reasonable number of regulatory alternatives to determine the regulatory requirements in the proposed PFAS NPDWR.
This action may significantly or uniquely affect small governments. EPA consulted with small governments concerning the regulatory requirements that might significantly or uniquely affect them.
Executive Order 13132: Federalism
EPA has concluded that this action has Federalism implications, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it imposes substantial direct compliance costs on state or local governments. EPA consulted with state and local governments early in the process of developing the proposed action to allow them to provide meaningful and timely input into its development. EPA held a Federalism consultation on February 24, 2022. EPA invited the following national organizations representing State and local elected officials to a virtual meeting on February 24, 2022: The National Governors' Association, the National Conference of State Legislatures, the Council of State Governments, the National League of Cities, the U.S. Conference of Mayors, the National Association of Counties, the International City/County Management Association, the National Association of Towns and Townships, the County Executives of America, and the Environmental Council of States. Additionally, EPA invited ASDWA, AMWA, NRWA, AWWA, the American Public Works Association (APWA), the Western Governors' Association (WGA), and other organizations to participate in the meeting. In addition to input received during the meeting, EPA provided an opportunity to receive written input within 60 days after the initial meeting. A summary report of the views expressed during Federalism consultations is available in the Docket (EPA - HQ - OW - 2022 - 0114).
In addition to the Federalism consultation, regarding state engagement more specifically, EPA notes there were multiple meetings held by the Association of State Drinking Water Administrators where EPA gathered input from state officials related to the considerations for the development of the proposed rule.
Executive Order 13175: Consultation and Coordination with Indian Tribal Governments
EPA has concluded that this proposed rule has Tribal implications, because it will impose direct compliance costs on Tribal governments, and the federal government will not provide funds necessary to pay those direct compliance costs. However, EPA notes that the federal government will provide a potential source of funds necessary to offset some of those direct compliance costs through the Bipartisan Infrastructure Law (BIL).
EPA has identified 998 PWSs serving tribal communities, 84 of which are federally owned. EPA estimates that tribal governments will incur public water system compliance costs of $5 million per year attributable to monitoring, treatment or non-treatment actions to reduce PFAS in drinking water, and administrative costs, and that these estimated impacts will not fall evenly across all tribal systems. The proposed PFAS NPDWR does offer regulatory relief by providing flexibilities for all water systems to potentially utilize pre-existing monitoring data in lieu of initial monitoring requirements and for groundwater CWSs and NTNCWSs serving 10,000 or fewer to reduce initial monitoring from quarterly monitoring during a consecutive 12-month period to only monitoring twice during a consecutive 12-month period. These flexibilities may result in implementation cost savings for many tribal systems since 98 percent of tribal CWSs and 94 percent of NTNCWs serve 10,000 or fewer people.
Accordingly, EPA provides the following Tribal summary impact statement as required by section 5(b) of Executive Order 13175. Consistent with EPA Policy on Consultation and Coordination with Indian Tribes (May 4, 2011), EPA consulted with Tribal officials and their representatives early in the process of developing this proposed regulation to permit them to have meaningful and timely input into its development. EPA conducted consultation with Indian Tribes beginning on February 7, 2022, and ending on April 16, 2022. The consultation included two national webinars with interested tribes on February 23, 2022, and March 8, 2022, where EPA provided proposed rulemaking information and requested input. A total of approximately 35 tribal representatives participated in the two webinars. Updates on the consultation process were provided to the National Tribal Water Council and EPA Region 6's Regional Tribal Operations Committee upon request at regularly scheduled monthly meetings during the consultation process. Additionally, EPA received written comments from the following Tribes and Tribal organizations: Little Traverse Bay Bands of Odawa Indians, Sault Ste. Marie Tribe of Chippewa Indians, and National Tribal Water Council. A summary report of the webinars and views expressed during the consultation is available in the Docket (EPA-HQ-OW-2022-0114).
Consultations with the Science Advisory Board, National Drinking Water Advisory Council, and the Secretary of Health and Human Services
In accordance with sections 1412(d) and 1412(e) of SDWA, the Agency consulted with the National Drinking Water Advisory Council (NDWAC or the Council); the Secretary of Health and Human Services; and with the EPA Science Advisory Board (SAB).
The SAB PFAS Review Panel met virtually via a video meeting platform on December 16, 2021, and then at three (3) subsequent meetings on January 4, 6 and 7, 2022 to deliberate on the Agency's charge questions. Another virtual meeting was held on May 3, 2022, to discuss their draft report. Oral and written public comments were considered throughout the advisory process. EPA sought guidance from the EPA SAB on how best to consider and interpret life stage information, epidemiological and biomonitoring data, the Agency's physiologically-based pharmacokinetic (PBPK) analyses, and the totality of PFAS health information to derive a MCLG for PFOA and PFOS, combined toxicity framework, and cardiovascular disease. The documents sent to SAB were EPA's Proposed Approaches to the Derivation of a Draft Maximum Contaminant Level Goal for Perfluorooctanoic Acid (PFOA) (CASRN 335-67-1) in Drinking Water; EPA's Proposed Approaches to the Derivation of a Draft Maximum Contaminant Level Goal for Perfluorooctane Sulfonic Acid (PFOS) (CASRN 1763-23-1) in Drinking Water; EPA's Draft Framework for Estimating Noncancer Health Risks Associated with Mixtures of Per- and Polyfluoroalkyl Substances (PFAS); and EPA's Analysis of Cardiovascular Disease Risk Reduction as a Result of Reduced PFOA and PFOS Exposure in Drinking Water. On May 3 and July 20, 2022, EPA received input from SAB, summarized in the report, SAB Advice on Approaches to Derive a Maximum Contaminant Level Goals for Perfluorooctanoic acid (PFOA), Perfluorooctanesulfonic acid (PFOS), Combined Toxicity Framework, and Cardiovascular Disease Risk Reduction (SAB, 2022i). The final SAB consensus report was transmitted to EPA on August 22[nd], 2022.
The Agency consulted with NDWAC during the Council's April 19, 2022, virtual meeting. A summary of the NDWAC recommendations is available in the National Drinking Water Advisory Council, Fall 2022 Meeting Summary Report (NDWAC, 2022 https://www.federalregister.gov/documents/2022/03/29/2022-06576/meeting-of-the-national-drinking-water-advisory-council) and the docket for this proposed rule. EPA carefully considered NDWAC recommendations during the development of a proposed drinking water rule for PFAS, including PFOA and PFOS.
On September 28[th], 2022, EPA consulted with the Department of Health and Human Services (HHS). EPA provided information to HHS officials on the draft proposed NPDWR and considered HHS input as part of the interagency review.
Effects of Less Frequent Collection
EPA considered a wide range of alternatives for frequency of collection that could still allow the Agency to meet its statutory requirements and overall objectives. EPA is taking comment on the initial and compliance monitoring schedules that would protect public health without imposing excessive burdens of systems and primacy agencies. The collection schedule proposed here is believed to meet this balance. Less frequent data collection may not be sufficient to ensure that system annual average concentrations of regulated PFAS are in compliance with the proposed MCLs.
Monitoring frequencies account for statutory requirements, which specify that monitoring be varied based on the number of people served by a PWS, contaminants likely to be found, and source of water supply. The monitoring frequency design also considers that the number of people served affects exposure to contaminants and considers resources available to undertake monitoring activity. The collection frequencies in this rule are discussed further in Section V.D of this ICR supporting statement. Monitoring frequencies have been carefully devised based on the following factors:
Data quality needed for a representative sample;
Precision and accuracy needed from the representative sample;
Number of people served by the PWS;
Source of the supply (e.g., surface water or ground water);
Likelihood of finding contaminants; and
Temporal variability in occurrence.
This proposed PFAS NPDWR puts in place a framework that sets individual MCLs for PFOA and PFOS. It also sets an MCL according to a Hazard Index approach for PFNA, PFHxS, PFBS, and GenX Chemicals.
This proposed rule designates an initial monitoring period in which systems will submit quarterly monitoring data. Groundwater systems serving a population of 10,000 or fewer, are only required to submit two quarterly samples for initial monitoring. Previously acquired data may be accepted to meet the initial monitoring requirements.
After the initial monitoring period, this proposed rule establishes a trigger level. Systems that do not exceed the trigger level will monitor every three years (one or two samples per three-year period, depending on system size). Systems that exceed the trigger level will be required to monitor quarterly for regulated PFAS.
More detailed information on monitoring schedules can be found in Section V.D of this ICR supporting statement.
General Guidelines
This ICR was completed in accordance with the October 2009 version of "EPA's Guide to Writing Information Collection Requests Under the Paperwork Reduction Act of 1995" (hereafter, the "ICR Handbook"). The ICR Handbook was prepared by EPA's Office of Environmental Information, 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.
This collection complies with all OMB guidelines for information collection activities. Specifically, the respondents are not required to:
Prepare a written response to a collection of information in fewer than 30 days after receipt of a request.
Submit more than an original and two copies of any document.
Retain records, other than health, medical, government contract, grant-in-aid. or tax records, for more than three years.
Participate in a statistical survey that is not designed to produce data that can be generalized to the universe of the study.
Use a statistical data classification that has not been reviewed and approved by OMB.
Receive a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use.
Submit proprietary, trade secret, or other confidential information unless EPA can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.
Confidentiality
 This information collection does not require respondents to disclose confidential information.
Sensitive Questions
 No questions of a sensitive nature are included in any of the information collection requirements outlined in this ICR.

The Respondents and the Information Requested
 Respondents/SIC 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 their primacy agency.
Primacy agencies, and EPA Regions that act as primacy agencies for states, territories, and tribal lands that do not have primacy.
The North American Industry Classification System (NAICS) code for privately owned PWSs is 22131. The NAICS codes for state agencies that include drinking water programs are 92411 (Administration of Air and Water Resources and Solid Waste Management Programs) or 92312 (Administration of Public Health Programs). Ancillary systems (systems where providing water is ancillary to a primary business, e.g., mobile home parks) cannot be categorized in a single NAICS code. For ancillary systems, the NAICS code is that of the primary establishment or industry.
Information Requested
 Data items, including record keeping requirements
   The PFAS which will be included for regulation in the proposed rule are:
Perfluorooctanesulfonic acid (PFOS)
Perfluorooctanoic acid (PFOA)
Perfluorononanoic acid (PFNA)
Perfluorohexanesulfonic acid (PFHxS)
Perfluorobutanesulfonic acid (PFBS)
Hexafluoropropylene oxide dimer acid and its ammonium salt, (HFPO-DA, also known as GenX Chemicals)
The following table summarizes the information that PWSs must report to the primacy agency. All PWSs must electronically report that information with their sample results.
Systems required to sample must report to the State according to the timeframes and provisions of §141.31. Systems must report the information specified in the following table:
If you are a ...
You must report...
System monitoring for regulated PFAS under the requirements of § 141.XX(b) on a quarterly basis
1. The number of samples taken during the last quarter
2. The location, date, and result of each sample taken during the last quarter
3. The running annual average at each sampling point of all samples taken in the last four quarters
4. Whether, based on § 141.XX, the MCL was violated.
5. Whether, based on § 141.XX, the trigger level was met or exceeded.
System monitoring for regulated PFAS under the requirements of § 141.XX(b) less frequently than quarterly
1. The location, date, and result of each sample taken during the last monitoring period
2. The running annual average at each sampling point of all samples taken in the last twelve months
3. Whether, based on § 141.XX, the trigger level was met or exceeded.

 Respondent Activities
Respondents include both PWSs and States. State and PWS activities are discussed in sections VI.A(1) and VI.A(2), respectively.
Primacy Agency Activities
EPA anticipates Primacy Agencies will be involved in the following activities for the first three years after publication of the final rule:
Startup activities  -  read and understand the rule, adopt regulatory change, and provide internal and system staff with training and technical assistance;
Review the initial monitoring event results, including confirmation sample results for MCL exceedances; and
Review the results of ongoing compliance monitoring from systems.
Public Water System Activities
EPA anticipates systems will be involved in the following activities for the first three years after publication of the final rule:
Startup activities  -  read and understand the rule and attend initial training from the primacy agency;
Conduct initial monitoring including confirmation sampling for MCL exceedances; and
Conduct ongoing compliance, as needed
The Information Collected - Agency Activities, Collection Methodology, and Information Management
 Agency Activities
 The Agency is responsible for promulgating and overseeing the implementation of the proposed PFAS regulation. The Agency is involved in the following activities that assist primacy agencies in implementing the modifications:
Develop the regulation.
Respond to questions on the regulations.
The Agency will also conduct primacy activities in states, tribes, and territories that do not have primacy.
Collection Methodology and Management
 The data generated as a result of this proposed regulation will be integrated in the existing quarterly Safe Drinking Water Information System (SDWIS) reporting process. The collection methodology and management of SDWIS is described in the ICR entitled Public Water System Supervision Program (OMB control number 2040-0090; EPA ID 0270.46).
Small Entity Flexibility
The RFA of 1980, amended by the SBREFA of 1996, requires regulators to assess the effects of regulations on small entities including businesses, nonprofit organizations, and governments. RFA/SBREFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities (SISNOSE). Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of the proposed rule on small entities, EPA considered small entities to be systems serving 10,000 people or fewer. This is the cut-off level specified by Congress in the SDWA 1996 Amendments for small system flexibility provisions. As required by the RFA, EPA proposed using this alternative definition in the Federal Register (FR) (63 FR 7620, February 13, 1998), requested public comment, consulted with the SBA, and finalized the alternative definition in the Agency's Consumer Confidence Reports regulation (U.S. EPA, 1998b, 63 FR 44524, August 19, 1998). As stated in that Final Rule, the alternative definition would be applied for all future drinking water regulations. An SBAR Panel (or Panel) was convened to review the planned proposed rulemaking on the Proposed PFAS NPDWR. The panel consulted with and reported on the comments of SERs and made findings on issues related to elements of an IRFA under section 603 of the RFA. Detailed information on the overall panel process can be found in the panel report titled, Final Report of the Small Business Advocacy Review Panel on EPA's Planned Proposed Rule Per- and Polyfluoroalkyl Substances National Primary Drinking Water Regulation and can be found in the rulemaking docket EPA-HQ-OW-2022-0114.For a detailed description of the regulatory requirements under the proposed PFAS regulation see § 141.XX.d of the proposed Code of Federal Regulations (CFR) amendments. Under the proposed rule requirements, PWSs subject to the rule are required to conduct initial monitoring or demonstrate recent, previously collected monitoring data to determine the level of PFAS in their water system. The proposed NPDWR includes a provision, made available to PWSs of all sizes, including CWSs and NTNCWs serving 10,000 or fewer people, to use previously collected monitoring data that meets criteria specified in § 141.XX.c.2.v. of proposed CFR amendments. Based on initial monitoring results, systems will be required to conduct ongoing monitoring at least every three years (triennially) or as often as four times per year (quarterly). EPA is also requesting public comment on whether and under what criteria to allow the use of monitoring waivers in the final rule. EPA has included a provision in the proposed NPDWR in which groundwater systems serving a population of 10,000 or fewer may collect two quarterly samples over a one-year period for the purpose of initial monitoring, rather than collecting four quarterly samples.
Collection Schedule
EPA is proposing requiring CWS and NTNCWSs to monitor for certain PFAS. The Agency is proposing that monitoring frequency for a PWS is dependent on previous monitoring results, among other things. EPA is proposing that all surface water systems and groundwater systems serving greater than 10,000 are initially required to monitor quarterly within a 12-month period for PFAS. To provide additional flexibilities for small groundwater systems, EPA is also proposing and taking comment on a modification to the Standardized Monitoring Framework (SMF) for synthetic organic contaminants (SOCs) in that groundwater systems serving 10,000 or fewer are initially required to only monitor twice within a 12-month period for PFAS. In this proposal, all systems would be allowed to use previously acquired monitoring data to satisfy the initial monitoring requirements. EPA is also proposing that based upon the monitoring results, States would be able to reduce monitoring frequency for a system to once or twice every three years (depending on system size) if the State concludes that the system is reliably and consistently below the MCL, defined below. EPA is also proposing that water systems will conduct compliance monitoring to demonstrate that finished drinking water is below the MCLs for regulated PFAS. Under this proposal, PWSs must show the state that the contaminant is not present in the drinking water supply or, if present, is reliably and consistently below the proposed MCLs for PFAS. For compliance monitoring purposes described above, EPA is proposing a rule trigger level of one-third the MCL (0.0000013 mg/L or 1.3 ppt for PFOA and PFOS) or HI < 0.33 for HI PFAS (PFHxS, GenX Chemicals, PFNA, and PFBS as the highest concentration at which a contaminant may be judged to be "reliably and consistently" below the proposed MCLs for PFAS. As such, EPA is proposing to include the "rule trigger level" describe the circumstances in which water systems may be eligible for reduced monitoring for PFOA and PFOS in which the rule Trigger Level is set at one-third of the MCLs for regulated PFAS, i.e., 0.0000013 mg/L or 1.3 ppt for PFOA and PFOS, or at a HI of 0.33 for PFAS regulated by the HI (PFHxS, GenX Chemicals, PFNA, and PFBS). This rule trigger level determines whether a system may be considered to be "reliably and consistently" below the MCL. For those systems reliably and consistently below the MCLs, they must monitor according to the following schedule:
Systems that do not detect regulated PFAS in their systems above the rule trigger level (1.3 ppt), and that serve 3,300 or fewer customers will be required to analyze one sample per three-year compliance period.
Systems that do not detect regulated PFAS in their systems above the rule trigger level (1.3 ppt), and that serve a population of greater than 3,300 will be required to analyze samples in two consecutive quarters during each three-year compliance period.
PFAS Concentration
System Size (population served)
Compliance Monitoring Frequency
PFOA or PFOS <= 1.3 ppt or
HI <= 0.33
<= 3,300
Once every three years

> 3,300
Twice every three years, in two consecutive quarters

PFOA or PFOS > 1.3 ppt or
HI > 0.33
All regulated systems
Quarterly

Estimating the Burden and Cost of the Collection
If a water system is not reliably and consistently below the MCLs for regulated PFASit will be required to monitor quarterly at each entry point to the distribution system for regulated PFAS consistent with 40 CFR 141.24(g). Systems monitoring less frequently than quarterly whose sample result exceeds the rule trigger level defined by CFR 141.21(g) must also begin quarterly sampling. The state may allow the system to return to the reduced monitoring frequency when the state determines that the system is reliably and consistently below the MCL. However, states cannot determinate that the system is reliably and consistently below the MCL until at least one year of quarterly monitoring has occurred.  As part of this proposal, EPA is requesting public comment on the granting of monitoring waivers. Waivers are currently included in the monitoring schedule. Estimating the Burden and Cost of the Collection
 Estimating Respondent Burden
The PRA 44 U.S.C. 3501 et seq., requires EPA to estimate the burden, as defined in 5 CFR 1320.3(b), on PWSs and Primacy Agencies of complying with the rule. The information collected as a result of the proposed rule should allow Primacy Agencies and EPA to determine appropriate requirements for specific systems and evaluate compliance with the proposed rule. Burden is defined at 5 CFR 1320.3(b) and means the total time, effort, and financial resources required to generate, maintain, retain, disclose, or provide information to or for a federal agency. The burden includes the time needed to conduct Primacy Agency and system activities during the first three years after promulgation, as described below. In general, burden hours are calculated by:
Determining the activities that PWSs and States would complete to comply with the activity (as described in section IV.B(2));
Estimating the number of hours per activity (as described in section VI.A for systems and VI.B for States);
Estimating the number of respondents per activity; and,
Multiplying the hours per activity by the number of respondents for that activity.
 Public Water System Activities
This section summarizes the costs of the proposed rule for the following PWS activities:
Startup activities  -  read and understand the rule and attend initial training from the primacy agency;
Conduct initial monitoring including confirmation sampling for MCL exceedances; and
Conduct ongoing compliance, as needed.
PWS Implementation Administration Costs
EPA estimated costs associated with one-time actions to begin implementation of the rule including reading and understanding the rule and attending training provided by primacy agencies. EPA assumes that systems will conduct these activities during years one through three of the period of analysis. Table 1 lists the data elements and corresponding values associated with calculating the costs of these one-time implementation administration actions.
Table 1:Implementation Administration Costs (2021$)
Data element description
Data element value
The labor rate per hour for systems
$35.48 (systems <=3,300)
$37.84 (systems 3,301-10,000)
$39.94 (systems 10,001-50,000)
$41.70 (systems 50,001-100,000)
$48.74 (systems >100,000)
The average hours per system to read and adopt the rule
4 hours per system
The average hours per system to attend one-time training provided by primacy agencies
16 hours per system (systems <=3,300)
32 hours per system (systems >3,300)

PWS Monitoring Costs
As Table 1 shows, systems will collect quarterly samples at each entry point during the initial year of implementation, with the number of samples collected in each monitoring period varying by system size. Systems that have a detection will analyze the field reagent blank samples collected at the same time as the monitoring sample. Systems that have an MCL exceedance will collect one additional sample from the relevant entry point to confirm the results. The initial monitoring results determine which SMF sampling frequency a system will follow for the remaining two years of the implementation monitoring period (USEPA, 2004).
Table 2: Overview of Sampling Requirements per System Entry Point in the First Three Years
Initial Monitoring System Size Category
Initial 12-Month Monitoring Period
Long-Term Monitoring System Size Category
Long-Term Monitoring[a]: PFAS Detection < 1.3 ppt (PFOA or PFOS) or HI < 0.33
Long-Term Monitoring[a]: PFAS Detection >= 1.3 ppt (PFOA or PFOS) or HI >=0.33
<= 10,000
Surface Water: 1 sample every quarter
<= 3,300
1 triennial sample
1 sample every quarter

Ground Water: 1 sample every 6-month period

>10,000
Surface Water and Ground Water: 1 sample every quarter
>3,300
2 triennial samples
(1 sample in two consecutive quarters)
1 sample every quarter

Abbreviations: HI  -  health index; PFAS  -  per-and polyfluoroalkyl substances.
Notes:
[a] EPA used the following thresholds to distinguish whether PFAS concentrations are reliably and consistently below the MCL: PFOA and PFOS  -  one-third the MCL for each option; PFHxS  -  one-third the health benchmark of 9.0 ppt or 3.0 ppt because EPA lacks nationally representative occurrence data for the other PFAS in the HI.

For all systems, the activities associated with the sample collection in the initial 12-month monitoring period are the labor burden and cost for the sample collection and analysis, as well as a review of the sample results. Table 3 presents the data needs associated with the implementation monitoring period. The cost per entry point for each sampling activity is the product of the hourly labor cost and the hours plus the laboratory analysis cost. The laboratory analysis cost will include the additional field blank cost when occurrence values exceed method detection limits. The total cost is the sum of per-entry point costs.
Table 3: Sampling Costs (2021$)
Data Element Description
Data Element Value
Data Element Source
The labor rate per hour for systems
$35.48 (systems <=3,300)
$37.84 (systems 3,301-10,000)
$39.94 (systems 10,001-50,000)
$41.70 (systems 50,001-100,000)
$48.74 (systems >100,000)
WBS Technical Labor Cost
The number of samples per entry point per monitoring round for the initial monitoring in Year 1
2 samples (Ground Water systems <=10,000)
4 samples (all other systems)a
Proposed rule
The number of samples per entry point per long-term monitoring year for entry points that exceed the triennial monitoring threshold
4 samples (all systems)
Proposed rule
The number of samples per entry point per long-term monitoring round for  entry points that meet the triennial threshold
1 sample (systems <=3,300)
2 samples (systems >3,300)
Proposed rule
The hours per sample to travel to sampling locations, collect samples, record any additional information, submit samples to a laboratory, and review results
1 hour
UCMR5 ICR (EPA-HQ-OW-2020-0530-00141)
The laboratory analysis cost per sample for EPA Method 533
$376
UCMR5 ICR (EPA-HQ-OW-2020-0530-0141)
The laboratory analysis cost per sample for EPA Method 537.1
$302
UCMR5 ICR (EPA-HQ-OW-2020-0530-0141)
The laboratory analysis cost per sample for field reagent blank under EPA Method 533
$327[b]

The laboratory analysis cost per sample for the field reagent blank under EPA Method 537.1
$266[b]

Abbreviations: EPA  -  Environmental Protection Agency; Ground Water  -  ground water ICR; UCMR) Unregulated Contaminant Monitoring Rule); WBS (work breakdown structure).
Note:
[a] Systems greater than 3,300 will rely on UCMR5 data and a subset of other systems will rely on data in the State PFAS Monitoring Database.
[b] This incremental sample cost applies to all samples that exceed method detection limits. EPA used the Method 537.1 detection limits to apply this cost because Method 533 does not include detection limits
The estimates of total responses, burden, and cost for system activities is provided in Table 4.
Table 4: Total Burden, Costs, and Responses for Each Required Activity Item
Burden
(hours)
Costs (Million $2021)
Responses
System startup activities
 1,485
$52.8
 133,060
Systems collect initial samples
 1,127
$39.0
 218,557
Systems collect quarterly samples
 956
$35.2
 190,274
System subtotal
 3,568
$127.0
 541,891

 Primacy Agency Activities
This section summarizes the costs of the proposed rule for the following primacy agency activities:
Startup activities  -  read and understand the rule, adopt regulatory change, and provide internal and system staff with training and technical assistance;
Review the initial monitoring event results, including confirmation sample results for MCL exceedances; and
Review the results of ongoing compliance monitoring from systems.
Certain primary agency burdens are incurred in response to action taken by PWSs; for instance, the cost to primacy agencies of reviewing sample results depends on the number of samples taken at each entry point by each system under an agency's jurisdiction. Table 5 presents the data elements and corresponding values associated with calculating primacy Agency costs.
Table 5: Primacy Agency Costs (2021$)
Data element description
Data element value
The labor rate per hour for primacy agencies [a]
$58.14
The average hours per primacy Agency to read and understand the rule, as well as adopt regulatory requirements
416 hours per primacy Agency
The average hours per primacy Agency to provide initial training and technical assistance to systems
2,080 hours per primacy Agency
The average hours per primacy Agency to provide initial training to internal staff
250 hours per primacy Agency
The average hours per primacy Agency to report annually to EPA information under 40 CFR 142.15 regarding violations, variances and exemptions, enforcement actions and general operations of State public water supply programs
0[b]
The hours per sample for a primacy Agency to review sample results
1 hour
a. State employee wage rate of $33.91 from National Occupational Employment and Wage Estimates, United States, BLS SOC Code 19-2041, "State Government, excluding schools and hospitals - Environmental Scientists and Specialists, Including Health," hourly mean wage rate. May 2020 data (published in March 2021): https://www.bls.gov/oes/current/oes192041.htm. Wages are loaded using a factor of 62.2 from the BLS Employer Costs for Employee Compensation report, Table 3, March 2020. Percent of total compensation - Wages and Salaries - All Workers - State and Local Government Workers (https://www.bls.gov/news.release/archives/ecec_06182020.pdf). See worksheet BLS Table 3. The final loaded wage is adjusted for inflation.
b. EPA assumes that the proposed PFAS rule will have no discernable incremental burden for quarterly or annual reports to SDWIS/Fed.

The estimates of total responses, burden, and cost for primacy agency activities is provided in Table 6.
Table 6:. Total Burden, Costs, and Responses for Each Required Activity
Item
Burden
(thousand hours)
Costs (Million $2021)
Responses
Primacy agency startup activities
 154
$8.7
 168
Primacy agency review initial monitoring data
 73
$4.1
 160,370
Primacy agency review annual and quarterly samples
 48
$2.7
 95,137
Primacy agency subtotal
 274
 15.6
 255,675

Estimating Agency Burden and Cost
Information-related activities that may be undertaken by both EPA headquarters and regional offices include reviewing, interpreting and explaining the new regulations to primacy agencies that ask for guidance. For example, during the implementation process, EPA headquarters or regions might be asked for explanations or interpretations of the intent of the new regulations. However, the additional burden and costs incurred by EPA's drinking water program at headquarters and regional offices to assist primacy agencies in implementing drinking water regulations are already included in existing ICRs. EPA burden and costs for on-going regulatory development and support activities for all EPA drinking water regulations are accounted for under the PWS Supervision Program ICR (OMB control number 2040-0090, EPA ID 1895.10). This proposed rule does not create any additional Agency burden beyond that which is already described in the PWS Supervision Program ICR.
Estimating the Total Respondent Universe and Total Burden and Costs
For the first three years after publication of the rule in the Federal Register, information requirements apply to an average of 38,089 respondents annually, including 38,033 PWSs and 56 Primacy Agencies. The burden associated with the proposed rule over the three years covered by the ICR is 3.8 million hours, for an average of 1.3 million hours per year. The total cost over the three-year period is $142.6 million, for an average of $47.5 million per year (simple average over three years). The average burden per response (i.e., the amount of time needed for each activity that requires a collection of information) is 6.6 hours for PWSs and 1.1 hours for primacy agencies; the average cost per response is $234.41 for PWSs and $60.89 for primacy agencies. The collection requirements are mandatory under SDWA (42 U.S.C. 300g-7). Details on the calculation of the proposed rule information collection burden and costs can be found in the Section VI.A of this ICR supporting statement for the proposed rule and Chapter 5 of the Economic Analysis.
Bottom Line Burden Hours and Cost Tables
For the first three years after publication of the rule in the Federal Register, information requirements apply to an average of 38,089 respondents annually, including 38,033 PWSs and 56 Primacy Agencies. The burden associated with the proposed rule over the three years covered by the ICR is 3.8 million hours, for an average of 1.3 million hours per year. The total cost over the three-year period is $142.6 million, for an average of $47.5 million per year (simple average over three years). The average burden per response (i.e., the amount of time needed for each activity that requires a collection of information) is 6.6 hours for PWSs and 1.1 hours for primacy agencies; the average cost per response is $234.41 for PWSs and $60.89 for primacy agencies. The collection requirements are mandatory under SDWA (42 U.S.C. 300g-7). A summary of the average annual burden and costs of the collection is presented in Table 7. The burdens and costs reflect labor and laboratory analysis costs.
Table 7: Total Burden, Costs, and Responses for Each Required Activity
Item
Burden
(thousand hours)
Costs (Million $2021)
Responses
System startup activities
 1,485
$52.8
 133,060
Systems collect initial samples
 1,127
$39.0
 218,557
Systems collect quarterly samples
 956
$35.2
 190,274
System subtotal
 3,568
127.0
 541,891
Primacy agency startup activities
 154
$8.7
 168
Primacy agency review initial monitoring data
 73
$4.1
 160,370
Primacy agency review quarterly samples
 48
$2.7
 95,137
Primacy agency subtotal
 274
 15.6
 255,675
Combined systems and primacy agency
 3,842
 142.6
 797,566
Note: Detail may not add to totals because of independent rounding.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
As part of the Federal Register notice on the proposed rule, EPA will solicit comments on this information collection and the estimates in this ICR. EPA will solicit comments on specific aspects of the proposed information collection, as described below:
          EPA's need for this information.
          The accuracy of the provided burden estimates.
          Any suggested methods for minimizing respondent burden.
Comments should be directed to Docket ID Number EPA-HQ-OW-2022-0114.
The Agency Tally
As noted in section VI.C, the EPA burden and costs for on-going regulatory development and support activities for all EPA drinking water regulations are accounted for under the PWS Supervision Program ICR. Therefore, this proposed rule does not create any additional Agency burden beyond that which is already described in the latest version of the PWS Supervision Program ICR (OMB control number 2040-0090, EPA ID 1895.10).
2. Variations in the Annual Bottom Line
EPA assumes the rule implementation and startup activities will take place in the first year, while initial monitoring collection and review will be distributed uniformly over the first three years.
Reasons for Change in Burden
       The proposed PFAS NPDWR is intended to protect public health through the reduction of PFAS exposure in drinking water. EPA needs comprehensive and current information on PFAS exposure and associated enforcement activities to implement its program oversight and enforcement responsibilities mandated by SDWA. Primacy agencies need the information to identify significant contaminant concentrations that might threaten the health and safety of drinking water consumers in a timely fashion.
Burden Statement
For the first three years after publication of the rule in the Federal Register, information requirements apply to an average of 38,089 respondents annually, including 38,033 PWSs and 56 Primacy Agencies. The burden associated with the proposed rule over the three years covered by the ICR is 3.8 million hours, for an average of 1.3 million hours per year. The total cost over the three-year period is $142.6 million, for an average of $47.5 million per year (simple average over three years). The average burden per response (i.e., the amount of time needed for each activity that requires a collection of information) is 6.6 hours for PWSs and 1.1 hours for primacy agencies; the average cost per response is $234.41 for PWSs and $60.89 for primacy agencies. The collection requirements are mandatory under SDWA (42 U.S.C. 300g-7). A summary of the average annual burden and costs of the collection is presented in Table 7. These burden and cost estimates represent those activities that EPA expects would occur in the initial three-year period. During this period, systems and primacy agencies would perform the initial, one-time activities related to rule review and primacy requirements. Because implementation does not begin during the initial three-year period, this ICR does not include burden and costs for activities that are required during full rule implementation (e.g., primacy agencies reporting data to SDWIS and water systems reporting tap sampling, other monitoring results and regulatory milestones).
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 Number EPA-HQ-OW-2022-0114, which is available for online viewing at www.regulations.gov. This site can be used 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. When in the system, select     "search," then key in the Docket ID Number identified above. Comments can also be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number (EPA-HQ-OW-2022-0114) and the OMB Control Number 2040-AG18 in any correspondence.

APPENDIX A: SDWA Sections that Provide Authority for the Collection

Section 1401. For purposes of this title:
(1) The term "primary drinking water regulation" means a regulation which-
 contains 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 to insure compliance with such levels and to insure proper operation and maintenance of the system, and requirements as to (i) the minimum quality of water which may be taken into the system and (ii) siting for new facilities for public water systems. At any time after promulgation of a regulation referred to in this paragraph, the Administrator may add equally effective quality control and testing procedures by guidance published in the Federal Register. Such procedures shall be treated as an alternative for public water systems to the quality control and testing procedures listed in the regulation.
Section 1413(a)(1) of SDWA allows EPA to grant a state primary enforcement responsibility ("primacy") for NPDWRs when EPA has determined that the state has, among other things, adopted regulations that are no less stringent than EPA's (42 U.S.C. § 300g-2(a)(1)). To obtain primacy for this rule, states must adopt comparable regulations within two years of EPA's promulgation of the final rule, unless EPA grants the state a two-year extension. 40 CFR 142.12(b). State primacy requires, among other things, adequate enforcement (including monitoring and inspections) and reporting. EPA must approve or deny state primacy applications within 90 days of submission to EPA (42 U.S.C. § 300g-2(b)(2)). In some cases, a state submitting revisions to adopt an NPDWR has interim primary enforcement authority for the new regulation while EPA's decision on the revision is pending (42 U.S.C. § 300g-2(c)).
Section 1413(a) For purposes of this title, a state has primary enforcement responsibility for public water systems during any period for which the Administration determines (pursuant to regulations under subsection (b)) that such state-
 has adopted drinking water regulations that are no less stringent than the national primary drinking water regulations promulgated by the Administrator under subsections (a) and (b) of section 1412 not later than 2 years after the date on which the regulations are promulgated by the Administrator, except that the Administrator may provide for an extension of not more than 2 years if, after submission and review of appropriate, adequate documentation from the state, the Administrator determines that the extension is necessary and justified;
 has adopted and is implementing adequate procedures for the enforcement of such state regulations, including conducting such monitoring and making such inspections as the Administrator may require by regulation;
 will keep such records and make such reports with respect to its activities under paragraphs
(1) and (2) as the Administrator may require by regulation.
Section 1445(a) of SDWA authorizes the Administrator to establish monitoring, recordkeeping, and reporting regulations, to assist the Administrator in establishing regulations under SDWA, determining compliance with SDWA, and in advising the public of the risks of unregulated contaminants (42 U.S.C. § 300j-4(a)). In requiring a PWS to monitor under Section 1445(a), the Administrator may take into consideration the water system size and the contaminants likely to be found in the system's drinking water (42 U.S.C. § 300j-4(a)).
Section 1445(a)(1)(C) of SDWA provides that "every person who is subject to a national primary drinking water regulation" under section 1412 must provide such information as the Administrator may reasonably require to assist the Administrator in establishing regulations under section 1412 (42 U.S.C § 300j-4(a)(1)(C)).
Section 1445 (a)(1)(A) Every person who is subject to any requirement of this title or who is a grantee, 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 the Administrator in establishing regulations under this title, in determining whether such person has acted or is acting in compliance with this title, in administering any program of financial assistance under this title, in evaluating the health risks of unregulated contaminants, or in advising the public of such risks. In requiring a public water system to monitor under this subsection, the Administrator may take into consideration the system size and the contaminants likely to be found in the system's drinking water.
 Every person who is subject to a national primary drinking water regulation under section 1412 shall provide such information as the Administrator may reasonably require, after consultation with the state in which such person is located if such state has primary enforcement responsibility for public water systems, on a case-by-case basis, to determine whether such person has acted or is acting in compliance with this title.
 Every person who is subject to a national primary drinking water regulation under section 1412 shall provide such information as the Administrator may reasonably require to assist the Administrator in establishing regulations under section 1412 of this title, after consultation with primacy agencies and suppliers of water. The Administrator may not require under this subparagraph the installation of treatment equipment or process changes, the testing of treatment technology, or the analysis or processing of monitoring samples, except where the Administrator provides the funding for such activities. Before exercising this authority, the Administrator shall first seek to obtain the information by voluntary submission.
 The Administrator shall not later than 2 years after the date of enactment of this subparagraph, after consultation with public health experts, representatives of the general public, and officials of state and local governments, review the monitoring requirements for not fewer than 12 contaminants identified by the Administrator, and promulgate any necessary modifications.
Section 1450 of SDWA authorizes the Administrator to prescribe such regulations as are necessary or appropriate to carry out his or her functions under the Act (42 U.S.C § 300j-9).


[Federal Register Volume 88, Number 219 (Wednesday, November 15, 2023)]
[Notices]
[Pages 78371-78372]
[FR Doc No: 2023-25100]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0806]

Advisory Committee; Nonprescription Drugs Advisory Committee;
Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Nonprescription Drugs Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the
Nonprescription Drugs Advisory Committee for an additional 2 years
beyond the charter expiration date. The new charter will be in effect
until the August 27, 2025, expiration date.

DATES: Authority for the Nonprescription Drugs Advisory Committee will
expire on August 27, 2025, unless the Commissioner formally determines
that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Moon Hee Choi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Nonprescription
Drugs Advisory Committee (the Committee). The Committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner. The Committee advises the Commissioner or designee
in discharging responsibilities as they relate to helping to ensure
safe and effective drugs for human use and, as required, any other
product for which FDA has regulatory responsibility.
    The Committee reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (nonprescription) human
drug products, or any other FDA-regulated product, for use in the
treatment of a broad spectrum of human symptoms and diseases and
advises the Commissioner either on the promulgation of monographs
establishing conditions under which these drugs are generally
recognized as safe and effective and not misbranded or on the approval
of new drug applications for such drugs. The Committee serves as a
forum for the exchange of views regarding the prescription and
nonprescription status, including switches from one status to another,
of these various drug products and combinations thereof. The Committee
may also conduct peer

review of agency sponsored intramural and extramural scientific
biomedical programs in support of FDA's mission and regulatory
responsibilities.
    The Committee shall consist of 10 voting members including the
Chair. Members and the Chair are selected by the Commissioner or
designee from among authorities knowledgeable in the fields of internal
medicine, family practice, clinical toxicology, clinical pharmacology,
pharmacy, dentistry, and related specialties. Members will be invited
to serve for overlapping terms of up to 4 years. Non-Federal members of
this committee will serve as Special Government Employees,
representatives, or Ex-Officio members. Federal members will serve as
Regular Government Employees, or Ex-Officios. The core of voting
members may include one technically qualified member, selected by the
Commissioner or designee, who is identified with consumer interests and
is recommended by either a consortium of consumer-oriented
organizations or other interested persons. In addition to the voting
members, the Committee may include one non-voting representative member
who is identified with industry interests. There may also be an
alternate industry representative.
    Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/nonprescription-drugs-advisory-committee/nonprescription-drugs-advisory-committee-charter or by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact
that no change has been made to the Committee name or description of
duties, no amendment will be made to 21 CFR 14.100.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: November 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25100 Filed 11-14-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 43 (Friday, March 4, 2011)]
[Notices]
[Pages 12220-12221]
[FR Doc No: 2011-4952]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Petition for Exemption From the Federal Motor Vehicle Motor Theft
Prevention Standard; Jaguar Land Rover

AGENCY: National Highway Traffic Safety Administration, Department of
Transportation (DOT).

ACTION: Grant of petition for exemption.

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SUMMARY: This document grants in full the petition of Jaguar Land Rover
North America's, (Land Rover) petition for an exemption of the Range
Rover Evoque vehicle line in accordance with 49 CFR part 543, Exemption
from the Theft Prevention Standard. This petition is granted because
the agency has determined that the antitheft device to be placed on the
line as standard equipment is likely to be as effective in reducing and
deterring motor vehicle theft as compliance with the parts-marking
requirements of the Theft Prevention Standard (49 CFR part 541).

DATES: The exemption granted by this notice is effective beginning with
the 2012 model year.

FOR FURTHER INFORMATION CONTACT: Ms. Carlita Ballard, Office of
International Policy, Fuel Economy and Consumer Programs, NHTSA, W43-
439, 1200 New Jersey Avenue, SE., Washington, DC 20590. Ms. Ballard's
phone number is<PHONE_NUMBER>. Her fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a petition dated November 22, 2010, Land
Rover requested an exemption from the parts-marking requirements of the
theft prevention standard (49 CFR Part 541) for the Range Rover Evoque
vehicle line beginning with MY 2012. The petition has been filed
pursuant to 49 CFR part 543, Exemption from Vehicle Theft Prevention
Standard, based on the installation of an antitheft device as standard
equipment for the entire vehicle line.
    Under Sec.  543.5(a), a manufacturer may petition NHTSA to grant an
exemption for one vehicle line per model year. In its petition, Land
Rover provided a detailed description and diagram of the identity,
design, and location of the components of the antitheft device for the
Range Rover Evoque vehicle line. Land Rover stated that the Range Rover
Evoque vehicles will be equipped with a passive, transponder based,
electronic engine immobilizer antitheft device as standard equipment
beginning with the 2012 model year. Key components of its antitheft
device will include a power train module, instrument cluster, body
control module, remote frequency receive immobilizer antenna unit,
smart key, door control units and a perimeter alarm system. The
immobilizer device is automatically immobilized when the Smart Key is
removed from the vehicle. Land Rover stated that the Smart Key is
programmed and synchronized to the vehicle by means of a unique
identification code key and a secret code key which is randomly
generated and unique to each vehicle. Additionally, Land Rover states
that its antitheft device will include an audible and visual perimeter
alarm system as standard equipment that can be armed manually or
programmed to arm automatically with the Smart Key. If the hood,
luggage compartment, or doors are opened during an unauthorized entry,
the vehicle siren alarm will sound and the exterior lights will flash.
    Land Rover stated that there are three methods of vehicle operation
and engine start: (1) Pulling the driver's door handle with correct
Smart Key authentication, and pressing the ignition start button; (2)
unlocking the vehicle with the Smart Key unlock button; and (3) using
the emergency key blade.
    In addressing the specific content requirements of 543.6, Land
Rover provided information on the reliability and durability of its
proposed device. To ensure reliability and durability of the device,
Land Rover conducted tests based on its own specified standards. Land
Rover provided a detailed list of the tests conducted (i.e.,
temperature and humidity cycling, high and low temperature cycling,
mechanical shock, random vibration, thermal stress/shock tests,
material resistance tests, dry heat, dust and fluid ingress tests).
Land Rover stated that it believes that its device is reliable and
durable because it complied with specified requirements for each test.
Additionally, Land Rover stated that the vehicle's key recognition
sequence includes in excess of a billion code combinations with
encrypted data that is secure against copying. The coded data transfer
between modules also use a unique secure identifier, random number and
secure public algorithm.
    Land Rover stated that since the Range Rover Evoque is a new
vehicle line, there is no data from a previous generation vehicle to
compare theft rate data, although, it stated, the immobilizer in the
Range Rover Evoque is substantially similar to the antitheft device
installed on the MY 2010 Jaguar XJ vehicle line that was previously
granted an exemption by the agency on November 16, 2009. Land Rover
stated that based on 2006-2008 MY theft data information published by
NHTSA, Land Rover vehicles equipped with immobilizers had theft rates
that were below the median. Land Rover also stated that the immobilizer
in the Range Rover Evoque line is no less effective than devices NHTSA
has already granted full exemptions (i.e., Jaguar XK and XJ).
Additionally, Land Rover submitted a Highway Loss Data Institute news
release (July 19, 2000) showing an approximate 50% reduction in theft
for vehicles installed with an immobilizer device.
    Based on the evidence submitted by Land Rover, the agency believes
that the antitheft device for the Range Rover Evoque vehicle line is
likely to be as effective in reducing and deterring motor vehicle theft
as compliance with

the parts-marking requirements of the Theft Prevention Standard (49 CFR
541).
    Pursuant to 49 U.S.C. 33106 and 49 CFR 543.7(b), the agency grants
a petition for exemption from the parts-marking requirements of Part
541, either in whole or in part, if it determines that, based upon
substantial evidence, the standard equipment antitheft device is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of Part 541. The agency
finds that Land Rover has provided adequate reasons for its belief that
the antitheft device for the Range Rover Evoque vehicle line is likely
to be as effective in reducing and deterring motor vehicle theft as
compliance with the parts-marking requirements of the Theft Prevention
Standard (49 CFR part 541). This conclusion is based on the information
Land Rover provided about its device.
    The agency concludes that the device will provide the five types of
performance listed in Sec.  543.6(a)(3): Promoting activation;
attracting attention to the efforts of an unauthorized person to enter
or move a vehicle by means other than a key; preventing defeat or
circumvention of the device by unauthorized persons; preventing
operation of the vehicle by unauthorized entrants; and ensuring the
reliability and durability of the device.
    For the foregoing reasons, the agency hereby grants in full Land
Rover's petition for exemption for the Range Rover Evoque vehicle line
from the parts-marking requirements of 49 CFR part 541. The agency
notes that 49 CFR part 541, Appendix A-1, identifies those lines that
are exempted from the Theft Prevention Standard for a given model year.
49 CFR 543.7(f) contains publication requirements incident to the
disposition of all Part 543 petitions. Advanced listing, including the
release of future product nameplates, the beginning model year for
which the petition is granted and a general description of the anti-
theft device is necessary in order to notify law enforcement agencies
of new vehicle lines exempted from the parts marking requirements of
the Theft Prevention Standard.
    If Land Rover decides not to use the exemption for this line, it
should formally notify the agency. If such a decision is made, the line
must be fully marked according to the requirements under 49 CFR 541.5
and 541.6 (marking of major component parts and replacement parts).
    NHTSA notes that if Land Rover wishes in the future to modify the
device on which this exemption is based, the company may have to submit
a petition to modify the exemption. Part 543.7(d) states that a Part
543 exemption applies only to vehicles that belong to a line exempted
under this part and equipped with the antitheft device on which the
line's exemption is based. Further, Sec.  543.9(c)(2) provides for the
submission of petitions ``to modify an exemption to permit the use of
an antitheft device similar to but differing from the one specified in
that exemption.''
    The agency wishes to minimize the administrative burden that Sec.
543.9(c)(2) could place on exempted vehicle manufacturers and itself.
The agency did not intend in drafting Part 543 to require the
submission of a modification petition for every change to the
components or design of an antitheft device. The significance of many
such changes could be de minimis. Therefore, NHTSA suggests that if the
manufacturer contemplates making any changes, the effects of which
might be characterized as de minimis, it should consult the agency
before preparing and submitting a petition to modify.

    Authority: 49 U.S.C. 33106; delegation of authority at 49 CFR
1.50.

    Issued on: March 1, 2011.
Joseph S. Carra,
Acting Associate Administrator for Rulemaking.
[FR Doc. 2011-4952 Filed 3-3-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 82, Number 158 (Thursday, August 17, 2017)]
[Notices]
[Page 39118]
[FR Doc No: 2017-17390]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-480-000]

Florida Gas Transmission Company, LLC; Notice of Request Under
Blanket Authorization

    Take notice that on August 2, 2017, Florida Gas Transmission
Company, LLC (Florida Gas), 1300 Main Street, Houston, Texas 77002,
filed in the above referenced Docket, a prior notice request pursuant
to sections 157.205, 157.208, and 157.216 of the Commission's
regulations under the Natural Gas Act (NGA) for authorization to
abandon approximately 6.7 miles of the 8-inch-diameter Rinker Lateral,
associated measurement and regulation station, and appurtenant
facilities, all located in Miami-Dade County, Florida (Rinker
Facilities Abandonment Project), all as more fully set forth in the
application which is on file with the Commission and open to public
inspection.
    The filing may also be viewed on the web at http://www.ferc.gov
using the eLibrary link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this prior notice request should be
directed to Blair Lichtenwalter, Senior Director of Certificates,
Florida Gas Transmission Company, LLC, 1300 Main St., Houston, Texas,
77002, or call<PHONE_NUMBER>, or fax<PHONE_NUMBER>, or via email
<EMAIL_ADDRESS>    Specifically, Florida Gas proposes to abandon in place the Rinker
Lateral, which originates downstream of Lateral Line Valve (LLV) 20-90B
at Mile Post 914.0 on Florida Gas's mainline and the Rinker Measurement
and Regulation Station located at Rinker Portland Cement Corp's plant.
Florida Gas also proposes to abandon by removal LLV 20-90B. Florida Gas
states that Rinker Lateral and facilities have not been used to provide
interruptible or firm transportation in over two years. Florida Gas
further states that proposed abandonment would eliminate additional
capital and/or operating expenditures which could potentially result in
an increased net operating loss for Florida Gas as time goes on.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the Natural Gas Act (NGA) (18 CFR 157.205) file a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for protest. If a protest is filed and not
withdrawn within 30 days after the time allowed for filing a protest,
the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the e-Filing link.

    Dated: August 11, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-17390 Filed 8-16-17; 8:45 am]
BILLING CODE P6717-01-P