SUPPORTING STATEMENT FOR THE 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 Final Rule
December 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. 2040-0307
ICR Title: Implementation of the EPA’s PFAS National Primary Drinking Water Regulation
This document supports the EPA’s compliance with requirements of the Paperwork Reduction Act for the implementation of the 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 the EPA’s Office of Groundwater and Drinking Water in the Office of Water, EPA Headquarters. The information collection activities are accomplished by the least burdensome and least costly means and are not duplicated by other sources.
The 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 standards to protect against both naturally occurring and man-made contaminants that may be found in drinking water. The US EPA, states, and water systems then work together to make sure that these standards are met. The collection of information described in this document derive from the EPAs’ authorities under and responsibilities in implementing SDWA.
The monitoring information collected as a result of the final rule should allow primacy agencies and the EPA to determine appropriate requirements for specific systems and evaluate compliance with the rule. For the first three-year period following rule promulgation, the major information requirements concern primacy agency activities to implement the rule which include 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. Certain compliance actions for drinking water systems, specifically initial monitoring, would be completed during the three years following rule promulgation. Other compliance actions for drinking water systems (including ongoing compliance monitoring, administration, and treatment costs) would not begin until after three to five years due to the compliance 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. The 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 7
A. Title of the Information Collection 7
B. Short Characterization/Abstract 7
II. Need for and use of the Collection 9
A. Need/Authority for the Collection 9
B. Practical Utility/Users of the Data 10
III. Non duplication, Consultations, and Other Collection Criteria 11
A. Non duplication 11
B. Public Notice Required Prior to ICR submission to OMB 11
C. Consultations 12
D. Effects of Less Frequent Collection 20
E. General Guidelines 21
F. Confidentiality 22
G. Sensitive Questions 22
IV. The Respondents and the Information Requested 23
A. Respondents/SIC Codes 23
B. Information Requested 23
V. The Information Collected–Agency Activities, Collection Methodology, and Information Management 25
A. Agency Activities 25
B. Collection Methodology and Management 26
C. Small Entity Flexibility 26
D. Collection Schedule 27
VI. Estimating the Burden and Cost of the Collection 29
A. Estimating Respondent Burden 30
B. Estimating Agency Burden and Cost 37
C. Estimating the Total Respondent Universe and Total Burden and Costs 38
D. Bottom Line Burden Hours and Cost Tables 38
E. Reasons for Change in Burden 40
F. Burden Statement 40
APPENDIX A: SDWA Sections that Provide Authority for the Collection 43
TITLE: Information Collection Request for the Final PFAS National Primary Drinking Water Regulation
EPA ICR Number: 2732.01
OMB Control Number: 2040-0307
The EPA is promulgating 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, the EPA is finalizing individual regulatory determinations to regulate PFHxS, HFPO-DA (also known as and referred to as “GenX Chemicals” in this notice), and PFNA, and is promulgating individual MCLG and MCLs for PFHxS, HFPO-DA and PFNA at 0.00001 mg/L or 10 ppt each. Finally, the EPA is finalizing a regulatory determination for mixtures of PFHxS, HFPO-DA, PFNA and PFBS due to their co-occurrence and potential for dose additive health concerns when present as a mixture in drinking water. As such and concurrent with this final determination, the EPA is finalizing a Hazard Index (HI) of 1 as the MCLG and enforceable MCL to address any mixture containing two or more of PFHxS, HFPO-DA, PFNA and PFBS where they co-occur in drinking water.
Water systems1 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 agency2. 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 the 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 final PFAS NPDWR as described above. 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, such as including ongoing compliance monitoring, administration, and treatment costs.
Section 1412(b)(1)(A) of the Safe Drinking Water Act (SDWA) requires the 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.
The 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 ensure 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.
Primary users of the data collected under this ICR are water systems and their customers, primacy agencies, and the EPA. The information collected by the EPA is available to the public, via the 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).
The 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 final PFAS NPDWR are not available from any other source.
To comply with the 1995 Amendments to the Paperwork Reduction Act (PRA), the Agency will solicit public comment on this final 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, the EPA requested comment on the estimated respondent burden and other aspects of this information collection. Comments received were 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).
To help shape the development of the proposed and final PFAS NPDWR, the EPA engaged with multiple stakeholders representing a wide range of expertise and conducted a total of 6 consultations. The sections below describe these stakeholder engagement activities for the proposed and final 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
Executive Order 12898 (59 FR 7629, February 16, 1994) directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice (EJ) part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color and/or Indigenous peoples) 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), the EPA conducted an EJ analysis to assess the demographic distribution of baseline PFAS drinking water exposure and impacts anticipated to result from the final PFAS NPDWR. The EPA believes that the human health or environmental conditions that exist prior to this action result in or have the potential to result in disproportionate and adverse human health or environmental effects on people of color, low-income populations and/or Indigenous peoples. Additionally, the EPA believes that this action is likely to reduce existing disproportionate and adverse effects on people of color, low-income populations and/or Indigenous peoples. The information supporting this Executive Order review is contained in Chapter 8 of USEPA (2023j) and Appendix M of USEPA (2023i) and is available in the public docket for this action. This documentation includes additional detail on the methodology, results, and conclusions of the EPA’s EJ analysis.
Additionally, on March 2, 2022, and April 5, 2022, the EPA held public stakeholder meetings related to EJ and the development of the proposed NPDWR. The meetings provided an opportunity for the 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 the EPA received public comment on topics including establishing an MCL for PFAS, affordability of PFAS abatement options, limiting industrial discharge of PFAS, and the 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.
Under section 603 and 609(b) of the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), the 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, the EPA’s Small Business Advocacy Chairperson convened the Panel, which consisted of the Chairperson, the Director of the Standards and Risk Management Division within the 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, the 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 the EPA Administrator for consideration. As required by section 604 of the RFA, the EPA prepared a final regulatory flexibility analysis (FRFA) for this action. The FRFA addresses the issues raised by public comments on the IRFA for the proposed rule. The complete FRFA is available for review in Section 9.3 of the Economic Analysis in the docket.
This action contains a Federal mandate under 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, the EPA has prepared a written statement required under section 202 of UMRA that is included in the docket for this action (see Chapter 9 of the EA for the Final PFAS NPDWR) and briefly summarized here.
Consistent with UMRA section 205, the EPA identified and analyzed a reasonable number of regulatory alternatives to determine the MCL requirement in the final rule. See section XII of this preamble and Chapter 9 of the EA for the Final PFAS NPDWR (USEPA, 2024j) for alternative options that were considered.
Consistent with the intergovernmental consultation provisions of UMRA section 204, the EPA consulted with governmental entities affected by this rule. The EPA describes the government-to-government dialogue and comments from state, local, and tribal governments in section XIII.E. EO 13132: Federalism and section XIII.F. EO 13175: Consultation and Coordination with Indian Tribal Governments of the final NPDWR.
This action may significantly or uniquely affect small governments. The EPA consulted with small governments concerning the regulatory requirements that might significantly or uniquely affect them.
Executive Order 13132: Federalism
The EPA has concluded that this action has federalism implications because it imposes substantial direct compliance costs on state or local governments, and the Federal government will not provide the funds necessary to pay those costs. However, the EPA notes that the Federal government will provide a potential source of funds necessary to offset some of those direct compliance costs through the BIL. The EPA estimates that the net change in primacy agency related cost for state, local, and tribal governments in the aggregate to be $5 million (3 percent discount rate) or $7 million (7 percent discount rate). The 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. The EPA held a Federalism consultation on February 24, 2022. The 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, The 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, the 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). The EPA also received public comments from some of these organizations during the public comment period following the rule proposal. These individual organization comments are available in the Docket.
In addition to the Federalism consultation, regarding state engagement more specifically, the EPA notes there were multiple meetings held by the Association of State Drinking Water Administrators where the EPA gathered input from state officials related to the considerations for the development of the NPDWR.
Executive Order 13175: Consultation and Coordination with Indian Tribal Governments
The EPA has concluded that this final 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, the 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).
The EPA has identified 998 PWSs serving tribal communities, 84 of which are federally owned. The EPA estimates that tribal governments will incur public water system compliance costs of $6.8 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 final 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, the EPA provides the following Tribal summary impact statement as required by section 5(b) of EO 13175. Consistent with the EPA Policy on Consultation and Coordination with Indian Tribes (May 4, 2011), the 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. The 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 the 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 the EPA Region 6’s Regional Tribal Operations Committee upon request at regularly scheduled monthly meetings during the consultation process. Additionally, the 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). As required by section 7(a) of the EO, the EPA's Tribal Official has certified that the requirements of the EO have been met in a meaningful and timely manner. A copy of the certification is included in the docket for this action.
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. The 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, the 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 the EPA on August 22nd, 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 the proposed rule. A consultation with the NDWAC was additionally held on August 8, 2023, on the final PFAS NPDWR. The EPA carefully considered NDWAC recommendations during the development of a final drinking water rule for PFAS, including PFOA and PFOS.
On September 28th, 2022, the EPA consulted with the Department of Health and Human Services (HHS). The EPA provided information to HHS officials on the draft proposed NPDWR and considered HHS input as part of the interagency review. On November 2, 2023, the EPA consulted with HHS on the final rule. The EPA received and considered comments from the HHS for both the proposed and final rules through the interagency review process described in section XIII.A of the final NPDWR.
The 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. The EPA took 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 is believed to meet this balance and, informed by monitoring results, offers different monitoring frequencies based on regulated PFAS contamination risk. Less frequent data collection may not be sufficient to ensure that system concentrations of regulated PFAS are in compliance with the final MCLs.
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 final PFAS NPDWR puts in place a framework that sets individual MCLs for PFOA, PFOS, PFHxS, PFNA and HFPO-DA. It also sets an MCL according to a Hazard Index approach for mixtures of PFNA, PFHxS, PFBS, and GenX Chemicals.
This final 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 at each EPTDS. All surface water systems and groundwater systems serving greater than 10,000 are required to submit four quarterly samples for initial monitoring at each EPTDS. Previously acquired data may be accepted to meet the initial monitoring requirements.
Monitoring schedules under the final rule are determined at each individual EPTDS; therefore, a system may have different EPTDS on different long-term monitoring schedules. After the initial monitoring period, the final NPDWR establishes trigger levels for the determination of long-term compliance monitoring frequency.
More detailed information on monitoring schedules can be found in Section V.D of this ICR supporting statement.
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 the 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 the EPA can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.
This information collection does not require respondents to disclose confidential information.
No questions of a sensitive nature are included in any of the information collection requirements outlined in this ICR.
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 the 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.
The PFAS which will be included for regulation in the final 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 § 141.902(b)(1) on a quarterly basis |
1. All sample results, including the location, number of samples taken at each location, date, and concentrations reported. 2. Whether a trigger level, defined in § 141.902(a)(5), was met or exceeded in any samples. |
System monitoring for regulated PFAS under the requirements of § 141.902(b)(1) less frequently than quarterly |
1. All sample results, including the location, number of samples taken at each location, date, and concentrations reported. 2. Whether a trigger level, defined in § 141.902(a)(5), was met or exceeded in any samples.
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Respondents include both PWSs and States. State and PWS activities are discussed in sections VI.A(1) and VI.A(2), respectively.
The 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; and
Review the initial monitoring event results, including confirmation sample results for MCL exceedances.
The 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; and
Conduct initial monitoring including confirmation sampling for MCL exceedances.
The Agency is responsible for promulgating and overseeing the implementation of the final 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.
The data generated as a result of this final 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).
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 rule on small entities, the 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, the 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 the 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 final PFAS regulation, see Subpart Z of the proposed Code of Federal Regulations (CFR) amendments. Under the final rule requirements, PWSs subject to the rule are required to conduct initial monitoring or demonstrate recent, previously collected monitoring data to determine the levels of regulated PFAS in their water system. The final 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 § 141.902 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). Following quarterly monitoring, systems may be able conduct annual monitoring for sampling locations after four consecutive quarterly samples are determined to all be reliably and consistently below the MCLs. The EPA has included a provision in the final 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.
The EPA is requiring CWS and NTNCWSs to monitor for certain PFAS. The Agency is requiring that the monitoring frequency for each EPTDS at a PWS is dependent on previous monitoring results, among other things. Monitoring schedules under the final rule are determined at each individual EPTDS within a system; therefore, a system may have different EPTDS on different long-term monitoring schedules. The EPA is requiring all surface water systems and groundwater systems serving greater than 10,000 to initially monitor quarterly within a 12-month period for regulated PFAS at each EPTDS. To provide additional flexibilities for small groundwater systems, the EPA is also finalizing 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 regulated PFAS at EPTDS. All systems would be allowed to use previously acquired monitoring data to satisfy some or all of the initial monitoring requirements.
Based upon the initial monitoring results, States would be able to reduce long-term monitoring frequency for EPTDS within a system to once every three years if the State concludes that the system is below the rule trigger levels, defined below. All other EPTDS with initial monitoring results at or above the rule trigger levels, are required to conduct quarterly monitoring immediately following initial monitoring.
Systems will conduct long-term compliance monitoring to demonstrate that finished drinking water is below the MCLs for regulated PFAS. Under the final rule, PWSs must show the state that the contaminant is not present in the drinking water supply or, if present, is below the rule trigger levels and/or reliably and consistently below the MCLs for regulated PFAS. For compliance monitoring purposes described above, the EPA is setting a rule trigger level of one-half the MCLs (0.0000020 mg/L or 2.0 ppt for PFOA and PFOS and 0.00001 mg/L or 10 ppt for PFHxS, HFPO-DA, and PFNA) or HI < 0.5 for HI PFAS (PFHxS, GenX Chemicals, PFNA, and PFBS) as the highest concentration at which a contaminant may be eligible for reduced triennial monitoring. Each water system is required to conduct compliance monitoring at each EPTDS below the rule trigger according to the following schedule:
Systems are required to analyze one sample for all regulated PFAS per three-year compliance period at each EPTDS where the water system does not detect regulated PFAS at or above the rule trigger level (2.0 ppt for PFOA and PFOS, 5 ppt for PFHxS, HFPO-DA and PFNA, and 0.5 for the HI PFAS (PFHxS, HFPO-DA, PFNA, and PFBS))
EPTDS on triennial monitoring schedule with any results above the rule trigger levels are required to initiate quarterly monitoring.
All other EPTDS with any results at or above the rule trigger levels, are required to conduct quarterly monitoring. If following at least four quarterly samples over the period of one year, the state determines that the EPTDS is reliably and consistently below the MCL, the EPTDS is eligible to reduce to annual monitoring. After a system on annual monitoring collects three consecutive yearly samples at the EPTDS with all sample results below the rule trigger level, the EPTDS is eligible to further reduce to triennial monitoring.
If a water system is not reliably and consistently below the MCL for regulated PFAS it will be required to monitor quarterly at each entry to the distribution system for regulated PFAS consistent with 40 CFR 141.902. If a water system is not below rule trigger levels for regulated PFAS it will be required to monitor quarterly at each entry point to the distribution system for regulated PFAS for at least a period of one year. The state may allow the system to reduce monitoring frequency to annually when the state determines that the system is reliably and consistently below the MCL; however, states cannot determine that the system is reliably and consistently below the MCL until at least one year of quarterly monitoring has occurred demonstrating all sample results are below the MCL. Systems monitoring every three years whose sample result exceeds the rule trigger level defined by CFR 141.902(a)(5) must also begin quarterly sampling. As part of the final rule, waivers are not included in the monitoring schedule.
The PRA 44 U.S.C. 3501 et seq., requires the 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 the 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.
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
The 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. The 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 (2022$)
Data element description |
Data element value |
The labor rate per hour for systems |
$36.43 (systems ≤3,300) $38.84 (systems 3,301-10,000) $41.00 (systems 10,001-50,000) $42.81 (systems 50,001-100,000) $50.03 (systems >100,000) |
The average hours per system to read and adopt the rule |
4 hours per system |
The average hours per system to attend one-time training provided by primacy agencies |
16 hours per system (systems ≤3,300) 32 hours per system (systems >3,300)
|
As Table 2 shows, Systems will collect quarterly samples at each entry point during the first year of implementation, with the number of samples collected in each monitoring period varying by system size. Systems that have a detection will analyze the field reagent blank samples collected at the same time as the monitoring sample. Systems that have an MCL exceedance will collect one additional sample from the relevant entry point to confirm the results. The initial monitoring results determine which SMF sampling frequency a system will follow for the remaining two years of the implementation monitoring period (USEPA, 2004).
Table 2: Overview of Sampling Requirements per System Entry Point in the First Three Years
Initial Monitoring System Size Category |
Initial 12-Month Monitoring Period |
≤ 10,000 |
Surface Water: 1 sample every quarter |
Ground Water: 1 sample every 6-month period |
|
>10,000 |
Surface Water and Ground Water: 1 sample every quarter |
Abbreviations: HI – Hazard index; PFAS – per-and polyfluoroalkyl substances.
For all systems, the activities associated with the sample collection in the initial 12-month monitoring period are the labor burden and cost for the sample collection and analysis, as well as a review of the sample results. Table 3 presents the data needs associated with the implementation monitoring period. The cost per entry point for each sampling activity is the product of the hourly labor cost and the hours plus the laboratory analysis cost. The laboratory analysis cost will include the additional field blank cost when occurrence values exceed the MCL. The total cost is the sum of per-entry point costs.
Table 3: Sampling Costs (2022$)
Data Element Description |
Data Element Value |
Data Element Source |
The labor rate per hour for systems |
$36.43 (systems ≤3,300) $38.84 (systems 3,301-10,000) $41.00 (systems 10,001-50,000) $42.81 (systems 50,001-100,000) $50.03 (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 |
Final 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 537.1 |
$309 |
UCMR5 ICR (EPA-HQ-OW-2020-0530-0141) |
The laboratory analysis cost per sample for the field reagent blank under EPA Method 537.1 |
$273b |
UCMR5 |
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. The 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
Activity |
Burden (thousand hours) |
Costs (Million $2022) |
Responses |
System startup activities |
1,485 |
$55.5 |
133,060 |
Systems collect initial samples |
1,007 |
$36.7 |
373,103 |
System subtotal |
2,492 |
$92.2 |
506,163 |
This section summarizes the costs of the proposed rule for the following primacy agency activities:
Startup activities – read and understand the rule, adopt regulatory change, and provide internal and system staff with training and technical assistance; and
Review the initial monitoring event results, including confirmation sample results for MCL exceedances.
Certain primary agency burdens are incurred in response to action taken by PWSs; for instance, the cost to primacy agencies of reviewing sample results depends on the number of samples taken at each entry point by each system under an agency’s jurisdiction. Table 5 presents the data elements and corresponding values associated with calculating primacy Agency costs.
Table 5: Primacy Agency Costs (2022$)
Data element description |
Data element value |
The labor rate per hour for primacy agencies a |
$59.69 |
The average hours per primacy Agency to read and understand the rule, as well as adopt regulatory requirements, and train internal staff. |
4,320 hours per primacy agency |
The average hours per primacy Agency to provide initial training and technical assistance to systems |
1,500 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 |
0b |
The hours per sample for a primacy Agency to review sample results |
1 hour |
a. The EPA Lead and Copper Rule Revisions Economic Analysis (2020). The final loaded wage is adjusted for inflation.
b. The 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 $2022) |
Responses |
Primacy agency startup activities |
326 |
$19.5 |
112 |
Primacy agency review initial monitoring data |
73 |
$4.4 |
165,641 |
Primacy agency subtotal |
399 |
$23.8 |
165,753 |
Information-related activities that may be undertaken by both the 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, the 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 the 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. The EPA burden and costs for on-going regulatory development and support activities for all the EPA drinking water regulations are accounted for under the PWS Supervision Program ICR (OMB control number 2040-0090, EPA ID 1895.10). The EPA acts as the primacy agency for PWSs in Wyoming, DC, and also for many tribal PWSs. The total cost to the EPA to review initial monitoring data from these PWSs over the first three years of the proposed rule covered by the ICR is $282,269. This cost, and associated burden, is included in the primacy agency burden estimate in Table 6.
For the first three years after publication of the rule in the Federal Register, information requirements apply to an average of 33,594 respondents annually, including 33,538 PWSs and 56 Primacy Agencies. The burden associated with the proposed rule over the three years covered by the ICR is 2.9 million hours, for an average of 963,780 hours per year. The total cost over the three-year period is $116 million, for an average of $39 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 4.9 hours for PWSs and 2.4 hours for primacy agencies; the average cost per response is $182 for PWSs and $144 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.
A summary of the total burden 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 $2022) |
Responses |
System startup activities |
1,485 |
$55.5 |
133,060 |
Systems collect initial samples |
1,007 |
$36.7 |
373,103 |
System subtotal |
2,492 |
$92.2 |
506,163 |
Primacy agency startup activities |
326 |
$19.5 |
112 |
Primacy agency review initial monitoring data |
73 |
$4.4 |
165,641 |
Primacy agency subtotal |
399 |
$23.8 |
165,753 |
Combined systems and primacy agency |
2,891 |
$116.0 |
671,915 |
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 the EPA’s regulations in 40 CFR are listed in 40 CFR part 9.
As part of the Federal Register notice on the proposed rule, the EPA will solicit comments on this information collection and the estimates in this ICR. The EPA will solicit comments on specific aspects of the proposed information collection, as described below:
The 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 the 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).
The 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.
The final PFAS NPDWR is intended to protect public health through the reduction of PFAS exposure in drinking water. The 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.
For the first three years after publication of the rule in the Federal Register, information requirements apply to an average of 33,594 respondents annually, including 33,538 PWSs and 56 Primacy Agencies. The burden associated with the proposed rule over the three years covered by the ICR is 2.9 million hours, for an average of 963,780 hours per year. The total cost over the three-year period is $116 million, for an average of $39 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 4.9 hours for PWSs and 2.4 hours for primacy agencies; the average cost per response is $182 for PWSs and $144 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 the 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 the 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, the 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 the EPA. Please include the EPA Docket ID Number (EPA-HQ-OW-2022-0114) and the OMB Control Number 2040-0307 in any correspondence.
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 ensure compliance with such levels and to ensure 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 the EPA to grant a state primary enforcement responsibility (“primacy”) for NPDWRs when the EPA has determined that the state has, among other things, adopted regulations that are no less stringent than the 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 the EPA’s promulgation of the final rule, unless the 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. The EPA must approve or deny state primacy applications within 90 days of submission to the 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 the 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).
1 Community water systems (CWSs) are public water systems (PWSs) that have at least 15 service connections used by year-round residents or regularly serve at least 25 year-round residents. Non-transient non-community water systems (NTNCWSs) are PWSs that are not CWSs but regularly serve at least 25 of the same persons over six months a year. Throughout the rest of this document, the reference to water systems, systems, utilities, and PWSs include only these two types of PWS.
2 Throughout the rest of this document, the term primacy agency refers to a state, territory, or federally recognized tribe that has been granted primacy with respect to the NPDWRs or the appropriate EPA Region (where the state, territory, or tribe does not have primacy).
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | George Gardenier |
| File Modified | 0000-00-00 |
| File Created | 2024-11-16 |