2563ss03

ICR SUPPORTING STATEMENT

1. Identification of the Information Collection

1 (a) Title: Use of Lead Free Pipes, Fittings, Fixtures, Solder, and Flux for Drinking Water

OMB NO. 2040-0299

EPA ICR NO. 2563.02

1 (b) Short Characterization/Abstract

The Reduction of Lead in Drinking Water Act of 2011 (RLDWA, the Act) modified the technical definition of “lead free” by lowering the maximum lead content of pipes, fittings, and fixtures from 8% to 0.25% and introduced greater complexity to calculating lead free by requiring that level be met based on a weighted average of wetted surfaces. The Act also created exemptions for certain plumbing products from pre-existing lead free requirements. The final rule establishes product certification requirements for products intended for potable use applications in public water systems and residential or non-residential facilities to demonstrate compliance with the lead free requirements. EPA expects that these requirements for lead content in plumbing materials used in new installations and repairs will result in fewer sources of lead in drinking water and, consequently, will reduce adverse health effects associated with exposure to lead in drinking water. Manufacturers with 10 or more employees or importers entering products purchased from or manufactured by manufacturers with 10 or more employees must demonstrate compliance with the lead free definition by obtaining third party certification by an American National Standards Institute (ANSI) accredited, third party certification body. Firms with fewer than 10 employees can use a third party certification body or self-certify that their products conform to the Safe Drinking Water Act’s (SDWA) lead free requirements. This self-certification option also extends to custom fabricated products regardless of a manufacturer’s number of employees. This rule imposes a burden on states to enforce the statutory provisions in SDWA Section 1417(a)(1), which cross references updated statutory definition of lead free within the meaning of SDWA Section 1417(d) according to the 2011 Reduction of Lead in Drinking Water Act and the 2013 Community Fire Safety Act.

2. Need for and Use of the Collection

2 (a) Need/Authority for the Collection

EPA made changes to existing regulations to protect the public from lead in plumbing materials used in public water systems or residential or non-residential facilities providing water for human consumption based on the Reduction of Lead in Drinking Water Act of 2011 (RLDWA) and the Community Fire Safety Act of 2013 (CFSA). Section 1417 of the Safe Drinking Water Act (SDWA) prohibits the use and introduction into commerce of certain plumbing products that are not lead free. The RLDWA amended Section 1417 of the SDWA to revise the definition of “lead- free” to: (1) lower the allowable maximum lead content from 8.0 percent to a weighted average of 0.25 percent of the wetted surfaces of pipes, fittings, and fixtures; and (2) specify a required method for calculating lead content. In addition, the RLDWA created exemptions from the prohibitions in Section 1417 (also referred to as “lead-free requirements”) for plumbing products that are used exclusively for nonpotable services as well as for other specified products. The CFSA further amended Section 1417 to exempt fire hydrants from these requirements.

EPA established new requirements for manufacturers to certify compliance with the lead free requirements in Section 1417 of the SDWA. These certification requirements are intended to help ensure that only lead free plumbing products are used in repairs and new installations of potable use applications and, consequently, will reduce adverse health effects associated with exposure to lead in drinking water. EPA is also identifying specific products that are exempt from the lead free requirements based on EPA’s interpretation of the statutory exemptions. This clarification of the exemptions will decrease potential burden for manufacturers of certain products.

This rule imposes a burden on states to enforce the statutory provisions in SDWA Section 1417(a)(1), which cross references updated statutory definition of lead free within the meaning of SDWA Section 1417(d) according to the 2011 Reduction of Lead in Drinking Water Act and the 2013 Community Fire Safety Act.

The final rule contains a provision allowing the Administrator or his or her authorized representative to request and be provided with information deemed necessary to determine whether a person has acted or is acting in compliance with Section 1417 of SDWA or the rule. This includes information related to product certification. For costing purposes, for the rule’s economic analysis, EPA has assumed an average of 10 such requests per year. This burden is factored into primacy agency burden.

2 (b) Practical Utility/Users of the Data

The general public as well as plumbers and persons (who build or repair public water systems) will be the primary users of the data, to identify safe, lead free plumbing products used for conveying drinking water. In finalizing the rule requirements, EPA considered feedback from stakeholders, who expressed confusion over which plumbing products are safe for use with drinking water. The rule includes a requirement that manufacturers obtain a third party certification for products subject to the lead free requirements. The intent of the certification is not only to ensure that the lead content of these potable use products comply with the RLDWA lead free standard but to ensure that the public has access to reliable information. This will allow the public to make informed decisions on the products they use for drinking water applications.

All manufacturers taking advantage of the self-certification are required to at a minimum, post a certificate of conformity online or distribute it by other means with the product. Manufacturers that are required to obtain third party certification are likely to identify a product’s certification status directly on the product and/or on the package labeling. Both options will provide the public and professional installers with information necessary to determine that the products they are purchasing or installing are safe for potable use application and comply with the use prohibition in statute for the installation of products that are not lead free in drinking water supply systems and plumbing.

3. Non Duplication, Consultations, and Other Collection Criteria

3(a) Non duplication

There are currently no federal requirements to make information on lead content of plumbing products available to the public, including plumbers, installers, and do-it-yourselfers. The rule relies heavily on current, voluntary certification standards that already have a significant level of adoption among manufacturers of plumbing materials and water system components. Using this approach, duplication is avoided and rule costs on the regulated community are contained. Primary rule costs and burden are associated with the firms that are not currently utilizing the voluntary standard.

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

EPA submitted the ICR revision for “Use of Lead Free Pipes, Fittings, Fixtures, Solder, and Flux for Drinking Water” on July 11, 2023, in the Federal Register (88 FR 131). The final rule’s preamble provides a summary of the estimated impacts of the regulation, consistent with the Paperwork Reduction Act and referenced the ICR information contained in the docket for the proposed rule. EPA requested comment on the ICR information presented in the proposal.

Public Comments and Agency Response:

EPA did not receive public comments concerning the proposed ICR renewal.

3(c) Consultations

EPA conducted consultations with the American Foundry Society (AFS), Plumbing Manufacturers International (PMI), and the Association of State Drinking Water Administrators (ASDWA) during July 2023. The consultation did not result in any changes to the proposed ICR revisions.

3(d) Effects of Less Frequent Collection

EPA considered alternative frequencies of record retention for certified products, and ultimately chose to utilize a frequency that considers the maximum length of time a product certification is considered valid by third party certification bodies (already voluntarily used by some firms). EPA may request case-specific information from regulated firms. EPA projected future costs based on 10 such case-by-case requests per year. EPA estimates there are 2,193 manufacturing firms impacted by the rule, and information to be submitted to EPA in any single year is expected to average less than 0.5% of the total number of firms.

3(e) General Guidelines

With one exception, this information collection complies with the conditions set out in 5 CFR 1320.5(d)(2). The one provision requiring special justification (concerning a five-year records retention requirement) is discussed in section 3d above.

3(f) Confidentiality

Information related to a product’s certification status will be held by the individual domestic manufacturing firm or by the importer entering products purchased from or manufactured by a manufacturer. Since this information will not be provided to EPA except on a case-by-case basis upon request, there will be no need for measures to provide for confidentiality except as follows: If compliance with the statute or rule provisions requires investigation, the rule contains a provision allowing the Administrator or his or her authorized representative to request and be provided with information deemed necessary to determine whether a person has acted or is acting in compliance with Section 1417 of SDWA or the final rule. This includes information related to product certification. The frequency and need for requesting such case-specific information cannot be known in advance. For costing purposes, EPA has assumed an average of 10 such requests per year. The handling of such information requested will be consistent with EPA’s confidentiality regulations (at 40 CFR 2.201 et. seq.).

3(g) Sensitive Questions

This information collection activity does not involve any sensitive questions.

4. Respondents and Information Requested

4(a) Respondents/SIC Codes

The following North American Industry Classification System (NAICS) Codes are impacted by this ICR during the 3-year period.

NAICS Code	Description
326122	Plastics Pipe and Pipe Fitting Manufacturing
332911	Industrial Valve Manufacturing
332913	Plumbing Fixture Fitting and Trim Manufacturing
332919	Other Metal Valve and Pipe Fitting Manufacturing
332996	Fabricated Pipe and Pipe Fitting Manufacturing
332999	All Other Miscellaneous Fabricated Metal Product Manufacturing
333318	Other Commercial and Service Industry Machinery Manufacturing
333415	Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing
333911	Pump and Pumping Equipment Manufacturing
333999	All Other Miscellaneous General Purpose Machinery Manufacturing
334514	Totalizing Fluid Meter and Counting Device Manufacturing
335222	Household Refrigerator and Home Freezer Manufacturing
335228	Other Major Household Appliance Manufacturing
339991	Gasket, Packing, and Sealing Device Manufacturing

4(b) Information Requested

1. Data items, including record keeping requirements

The final rule requires manufacturers or importers to maintain documentation to substantiate product certification for at least five years from the date of the last sale of the product by the manufacturer or importer. Specific to third party certification, the manufacturer or importer must keep records for all products certified by an accredited third party certification body that include, at a minimum, documentation of certification and dates of certification and expiration. This documentation must be provided upon request to the Administrator as specified in § 143.20(b).

For self-certified products, manufacturers or importers must maintain, at a primary place of business within the United States, certificates of conformity and sufficient documentation to confirm that products meet the lead free requirements of the final rule. Sufficient documentation may include: detailed schematic drawings of the products indicating dimensions, calculations of the weighted average lead content of the product, lead content of materials used in manufacture, and other documentation used in verifying the lead content of a plumbing device. This documentation and certificates of conformity must be provided upon request to the Administrator as specified in § 143.20(b) and must be maintained for at least five years after the last sale of the product by the manufacturer or importer.

Firms will be renewing product certification and record keeping during the three years of this ICR. Primacy agencies are required to enforce certification requirements during this ICR period.

2. Respondent Activities

For the period covered by this ICR (the three years of this ICR period), manufacturers will incur burden to conduct the following rule compliance activities:

• Obtaining certification of products from an accredited third party certification body to document compliance with the lead free requirements as set forth in the SDWA.

• Maintaining records associated with the initial certification (conducted by an accredited third party certification body) that potable use products meet the requirements of NSF/ANSI Standard 372.

• Preparing the initial certificate of conformity and maintaining records for potable use products that are self-certified by the manufacturer as being lead free.

5. Agency Activities, Methods, and Information Management

5(a) Agency Activities

EPA’s burden for ad hoc information requests is assumed to be negligible.

5(b) Collection Methodology and Management

Any individual entity’s submittal of case-specific information, in response to EPA’s request, will be maintained in files of the Agency’s Office of Compliance and Enforcement, consistent with Federal record retention requirements.

5(c) Small Entity Flexibility

EPA has determined that 1,976 out of 2,193 plumbing product manufacturers potentially subject to this final rule meet the small business definitions. EPA’s analysis of projected impacts on small entities is described in detail in section VII (Economic Impacts) of the final rule Federal Register notice. EPA projects that none of the 1,976 affected small entities would experience an impact of costs exceeding 1 percent of revenue and no small entities would incur compliance costs exceeding 3 percent of revenue. Details of this analysis are presented in Chapter 6 of the Final Rule Technical Support Document, available in the docket, for the final rule.

5(d) Collection Schedule

During the period covered by this ICR, no collection activities by EPA are anticipated.

5. Estimating Burden and Cost

6(a) Estimating Primacy Burden and Costs

Read, Understand, and Adopt the Rule

Table 1 illustrates the one-time burden to read, understand, and adopt the rule. It assumes each of 57 non-federal primacy agency needs an average of 275.5 hours to read, understand and adopt the rule. Labor rate is from the Bureau of Labor Statistics (BLS) for 2022 for environmental scientists and specialists loaded with a 1.6 overhead factor. Total cost is labor rate multiplied by total hours.

Table 1: One-time Burden on Primacy Agencies to Read, Understand and Adopt Rule

Primacy Agencies	57
Hours per Agency	275.5
Labor Rate	$64.48/hour
Total Hours=Primacy agencies * hours per agency	15,704
Total Cost= Labor Rate * Total Hours	$1,012,562

Table 2 illustrates annual burden for primacy agencies to implement and enforce the standard. This assumes implementation and enforcement burden will consist of a reference to relevant state code (assumed to be negligible burden) and one hour per sanitary survey conducted per system. Each community water system (CWS) requires a sanitary survey once every three years, and each non-community water system (NCWS) requires a sanitary survey every five years. Labor rate is from the BLS for environmental scientists and specialists loaded with a 1.6 overhead factor. Annual burden is therefore 1 hour multiplied by the number of CWS from the SDWIS-Fed Data warehouse for 2023q1 (49,665) divided by 3 (=16,555), plus one hour times the number of NCWS (102,885) divided by 5 (=20,577). Total annual cost is labor rate multiplied by annual burden (Table 2).

Table 2: Annual Primacy Agency Confirmation to Enforce and Implement SDWA Section 1417(a)(1)

CWS Confirmation of Compliance, Adjusted Annual burden based on Sanitary Survey Frequency Requirement (A)	16,555
NCWS Confirmation of Compliance, Adjusted Annual burden based on Sanitary Survey Frequency Requirement (B)	20,577
Labor Rate (C)	$64.48/hour
Annual Burden Hours (D)=A+B	37,132
Total Annual Cost (E)=C*D	$2,394,246

6(b) Estimating Manufacturer Burden and Costs

Product Recertification

In developing estimates of burden and costs, EPA estimated the number of entities impacted to be 2,193 manufacturers of products (intended for potable water use), who must comply with the rule’s recertification requirements. They manufacture an estimated 5,137 product types, with three product families per product type. EPA estimates 38% of these products require annual recertification at manufacturers with fewer than 100 employees, and 10% at manufacturers with 100 or more employees. EPA assumes manufacturers with fewer than 10 employees with self-certify at 16 hours per produce family, while manufacturers with 10 or more employees with use third party certification at 8 hours per produce family. This burden is summarized in Table 3.

Table 3: Annual Manufacturer Recertification Burden

Manufacturer Size (no. of employees)	Number of Manufactured Product Types	Number of Families / Manufactured Product Type	Percent that Require Recertification	Unit Burden for Recordkeeping (hour/product family)	Total Burden (hours)
<10	2,003	3	38%	16	36,062
10-99	1,700	3	38%	8	15,300
100-499	822	3	10%	8	1,973
≥ 500	611	3	10%	8	1,467
Total	5,137				54,820

Manufacturer costs were derived as follows (displayed in table 4 below). Labor rate is from the BLS for Computer Control Programmers and Operators loaded with a 1.6 overhead factor. Unit cost for third party recertification was estimated at $3,200 per product family during initial rule writing and was used to develop total costs for third party recertification.

Table 4: Annual Manufacturer Recertification Burden

Manufacturer Size (no. of employees)	Labor Rate ($/hour)	Labor Cost for Annual Record Keeping ($/product family/yr)	Unit Cost for 3rd Party to Annually Recertify to NSF 372 ($/product family)	Total O&M Annual Third Party Recertification Cost	Total Costs for Annual Recertification ($)
<10	$35.35	1,274,882	0	0	1,274,882
10-99	$35.35	540,894	3,200	6,119,959	6,660,853
100-499	$35.35	69,761	3,200	789,313	859,074
≥ 500	$35.35	51,874	3,200	586,925	638,799
Total		1,937,410		7,496,197	9,433,607

Capital/Start-up Costs

There are no capital start-up costs related to this ICR.

6(c) Estimating Agency Burden and Cost

EPA burden for this ICR is limited to ad-hoc requests and is assumed to be negligible.

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

Respondents for this ICR include 2,193 manufacturers producing potable water pipes, fittings, or fixtures or sourcing such products from foreign manufacturers and 57 primacy agencies. Total labor burden is 127,100 hours for primacy agencies, and 164,460 for manufacturers over the three-year ICR period. Total cost is $8.2 million for primacy agencies and $28.3 million for manufacturers. Estimated average annual burden is 97,186 hours. Average annual cost is $12.2 million.

6(e) Bottom Line Burden Hours and Cost Table

Total Respondents	Total Burden (Hours)	Total Labor Costs (in millions)	Total Renewal Costs (O&M, in millions)	Total Costs (in millions)
2,250	418,660	14.0	22.5	36.5

6(f) Reasons for Change in Burden

This ICR renewal assumed manufacturers have complied with initial rule requirements and are responsible for recertifications and recordkeeping, while primacy agencies are responsible for developing and implementing oversight plans.

6(g) Burden Statement

The estimated average annual burden per-response for this ICR is 62.0 hours (418,660 total burden hours divided by 2250 responses at divided by three-year ICR period). Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information; processing and maintaining information; disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number EPA-HQ-OW-2015-0680, which is available for online viewing at www.regulations.gov, or in person viewing at the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is (202) 566-1744, and the telephone number for the Water Docket is (202) 566-2426. An electronic version of the public docket is available at www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When in the system, select “search,” then key in the Docket ID Number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA-HQ-OW-2015-0680 and OMB Control Number 2040-0299 in any correspondence.