[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Rules and Regulations]
[Pages 54235-54259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16869]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 141 and 143

[EPA-HQ-OW-2015-0680; FRL-10012-43-OW]
RIN 2040-AF55


Use of Lead Free Pipes, Fittings, Fixtures, Solder, and Flux for 
Drinking Water

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is finalizing 
changes to existing regulations to protect the public from lead in 
plumbing materials used in public water systems or residential or 
nonresidential facilities providing water for human consumption. The 
changes in this rule codify aspects of the Reduction of Lead in 
Drinking Water Act of 2011 (RLDWA) and the Community Fire Safety Act of 
2013 (CFSA). The RLDWA amended section 1417 of the Safe Drinking Water 
Act (SDWA), which prohibits the use and introduction into commerce of 
certain plumbing products that are not ``lead free.'' The RLDWA revised 
the definition of lead free to lower the allowable maximum lead content 
of plumbing products; and established a statutory method for 
calculating lead content. EPA is also establishing new requirements for 
manufacturers or importers that introduce into commerce products that 
must meet lead free requirements to certify such products as being in 
compliance with the lead free requirements in Section 1417 of the SDWA, 
as well as other changes to existing regulations to assist in 
implementation of Section 1417 of the SDWA, as amended. 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. The SUPPLEMENTARY 
INFORMATION section details EPA's changes to existing regulations as 
authorized under the SDWA as amended.

[[Page 54236]]


DATES: This final rule is effective on October 1, 2020. The compliance 
date for the product certification requirements in 40 CFR 143.19 is 
September 1, 2023. For purposes of judicial review, this rule is 
promulgated as of September 1, 2020.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. EPA-HQ-OW-2015-0680. All documents in the docket are listed on the 
https://www.regulations.gov website. Although listed in the index, some 
information is not publicly available, e.g., confidential business 
information (CBI) or other information whose disclosure is restricted 
by statute. Certain other material, such as copyrighted material, is 
not placed on the internet and will be publicly available only in hard 
copy form. This material can be viewed at the Water Docket in the EPA 
Docket Center, EPA/DC, EPA West William Jefferson Clinton Bldg., Room 
3334, 1301 Constitution Ave. NW, Washington, DC. The 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 Public Reading 
Room is 202-566-1744, and the telephone number for the Water Docket is 
202-566-2426. Publicly available docket materials are available 
electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Russ Perkinson, telephone number: 202-
564-4901; email address: [email protected], Office of Ground Water 
and Drinking Water, Standards and Risk Management Division (4607), 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460. Additional information may also be obtained from the 
following website: https://www.epa.gov/dwstandardsregulations/use-lead-free-pipes-fittings-fixtures-solder-and-flux-drinking-water.

SUPPLEMENTARY INFORMATION:

Abbreviations and Acronyms

AFS--American Foundry Society
ANSI--American National Standards Institute
CBI--Confidential Business Information
CFR--Code of Federal Regulations
CFSA--Community Fire Safety Act of 2013
FAQs--Frequently Asked Questions
NAICS--North American Industry Classification System
NSF--NSF International
O&M--Operations and Maintenance
PMI--Plumbing Manufacturers International
RFA--Regulatory Flexibility Act
RLDWA--Reduction of Lead in Drinking Water Act of 2011
SDWA--Safe Drinking Water Act
SIC--Standard Industrial Classification
UL--Underwriters Laboratories

Table of Contents

I. General Information
    A. Does this action apply to me?
    B. What action is EPA taking?
    C. What is EPA's authority for taking this action?
    D. What are the incremental costs and benefits of this action?
II. Background
III. Summary of Data Used
    A. Characterization of the Affected Industry
    B. Determining Baseline Industry Practices and Potential Costs 
of Compliance
IV. Final Rule
    A. Applicability and Scope
    B. No Labeling Requirement for Potable Use Products
    C. Exemptions
    D. Product Certification
    E. Other Regulatory Requirements and Clarifications
    F. Implementation Schedule
V. Costs
    A. Initial Administrative and Initial Implementation Costs
    B. Labeling Potable Use Products
    C. Product Certification
    D. Response to EPA Data Request Costs
VI. Economic Impact Analysis
    A. Annualized Social Costs Estimates
    B. Economic Impacts--Cost-to-Revenue Analysis
VII. Benefits
VIII. Statutory and Executive Orders Review
IX. References

I. General Information

    The United States has made tremendous progress in lowering 
children's blood lead levels. As a result of multiple federal laws and 
regulations, including the 1973 phase-out of lead in automobile 
gasoline, the 1978 federal regulation banning lead paint for 
residential and consumer use, the 1991 Lead and Copper Rule (LCR), and 
the 1995 ban on lead in solder in food cans, the median concentration 
of lead in the blood of children aged 1 to 5 years dropped from 15 
micrograms per deciliter in 1976-1980 to 0.7 micrograms per deciliter 
in 2013-2014, a decrease of 95 percent.
    Although childhood blood lead levels have been substantially 
reduced as a result of these actions, some children are still exposed 
to high levels of lead. Sources of lead include lead-based paint, 
drinking water, and soil contaminated by historical sources. The 
Federal Action Plan (Action Plan) to Reduce Childhood Lead Exposures 
and Associated Health Impacts, issued by the President's Task Force on 
Environmental Health Risks and Safety Risks to Children, December 2018, 
provides a blueprint for reducing further lead exposure and associated 
harm through collaboration among federal agencies with a range of 
stakeholders, including States, Tribes, and local communities, along 
with businesses, property owners, and parents. The Task Force comprises 
17 federal departments and offices, including the Department of Health 
and Human Services (HHS) and the Department of Housing and Urban 
Development.
    Through the Action Plan, EPA is committed to reducing lead 
exposures from multiple sources, including paint, ambient air, and soil 
and dust contamination, especially exposures of sources to children who 
are among the most vulnerable to the effects of lead. EPA is also 
focused on conducting critical research and improving public awareness 
by consolidating and streamlining federal messaging.
    To reduce exposure to lead through drinking water, the Action Plan 
highlights several key actions, including EPA's commitment to updating 
the Lead and Copper Rule, making regulatory changes in this final rule 
to protect the public from lead in plumbing materials, and assisting 
schools and childcare centers with the existing 3Ts approach (Training, 
Testing and Taking Action) for lead in drinking water. The Action Plan 
also highlights EPA's continued support to States and communities by 
providing funding opportunities through the Drinking Water State 
Revolving Fund and the Water Infrastructure Finance and Innovation Act 
loan program for updating and replacing drinking water infrastructure. 
For more information about the Federal Lead Action Plan, see https://www.epa.gov/sites/production/files/2018-12/documents/fedactionplan_lead_final.pdf.
    The Reduction of Lead in Drinking Water Act of 2011 (RLDWA) amended 
section 1417 of the Safe Drinking Water Act (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 of the SDWA 
(these prohibitions are 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 Community Fire Safety Act 
of 2013 (CFSA) further amended section 1417 of the SDWA to exempt fire 
hydrants from these requirements.

A. Does this action apply to me?

    The statutory prohibitions on use and introduction into commerce of 
certain products that are not lead free, which

[[Page 54237]]

are codified by this final rule, apply to any ``person'' as defined in 
the SDWA. This final rule applies to any person who would introduce 
plumbing products into commerce, such as manufacturers, importers, 
wholesalers, distributors, re-sellers, and retailers. It also applies 
to any person who would use plumbing products in the installation or 
repair of a public water system, such as an installation contractor, or 
in a residential or nonresidential facility providing water for human 
consumption, such as a plumber. If you have questions regarding the 
applicability of this action to a particular entity, consult the person 
listed in the FOR FURTHER INFORMATION CONTACT section.

B. What action is EPA taking?

    EPA is codifying revisions to the SDWA's prohibition on use and 
introduction into commerce of certain products that are not lead free 
(hereafter referred to as the SDWA lead prohibitions). The SDWA lead 
prohibitions, first enacted in 1986, were amended in 1996, and most 
recently in the RLDWA and the Community Fire Safety Act of 2013 (CFSA). 
This codification will further assure consistent implementation and 
enforcement of the SDWA lead prohibitions on use and introduction into 
commerce of certain products that are not lead free. EPA is also 
establishing requirements to certify plumbing products introduced into 
commerce to help ensure that only lead free pipes, fittings, and 
fixtures are used in repairs and new installations of a public water 
system or in a residential or nonresidential facility providing water 
for human consumption (i.e., potable use applications).
    The SDWA, section 1417(a)(1), prohibits the use of any pipe, any 
pipe or plumbing fitting or fixture, any solder, or any flux in the 
installation or repair of any public water system, or any plumbing in a 
residential or nonresidential facility providing water for human 
consumption that is not ``lead free'' as defined in section 1417(d). 
Section 1417(a)(3) of the SDWA further provides that ``it shall be 
unlawful (A) for any person to introduce into commerce any pipe, or any 
pipe or plumbing fitting or fixture, that is not lead free, except for 
a pipe that is used in manufacturing or industrial processing; (B) for 
any person engaged in the business of selling plumbing supplies, except 
manufacturers, to sell solder or flux that is not lead free; or (C) for 
any person to introduce into commerce any solder or flux that is not 
lead free unless the solder or flux bears a prominent label stating 
that it is illegal to use the solder or flux in the installation or 
repair of any plumbing providing water for human consumption.''
    The 2011 RLDWA revised section 1417 to redefine lead free in SDWA 
section 1417(d) to (1) lower the maximum lead content from 8.0 percent 
to a weighted average of 0.25 percent of the wetted surfaces of pipes, 
fittings, and fixtures; (2) specify a required method for the 
calculation of lead content; and (3) eliminate the requirement that 
lead free products be in compliance with voluntary standards 
established in accordance with the SDWA, section 1417(e), for leaching 
of lead from new plumbing fittings and fixtures. In addition, the RLDWA 
created two categories of exemptions from the prohibitions on the use 
or introduction into commerce for (1) ``pipes, pipe fittings, plumbing 
fittings, or fixtures, including backflow preventers, that are used 
exclusively for nonpotable services such as manufacturing, industrial 
processing, irrigation, outdoor watering, or any other uses where the 
water is not anticipated to be used for human consumption''; and (2) 
``toilets, bidets, urinals, fill valves, flushometer valves, tub 
fillers, shower valves, service saddles, or water distribution main 
gate valves that are 2 inches in diameter or larger.'' (SDWA, sections 
1417(a)(4)(A) and (B)). The CFSA further amended section 1417(a)(4)(B) 
of the SDWA to add fire hydrants to the list of excluded devices. By 
this regulation, EPA is identifying several additional types of 
products (e.g., clothes washing machines) that are exempt from the lead 
free requirements, which will decrease burden for manufacturers without 
endangering public health and safety.
    In addition to codifying the revised requirements under RLDWA and 
CFSA, EPA is establishing regulations for product certification and 
information collection to help ensure consistent implementation and 
enforcement of the SDWA lead prohibitions. The final rule does not 
require the marking and labeling of lead free pipes, fittings, or 
fixtures as EPA had initially proposed. Having reviewed public comments 
on this issue, EPA has reconsidered the matter, and EPA anticipates 
that the final rule's certification provisions, combined with the 
widespread practice of voluntary labeling by firms that obtain third 
party certification, will likely result in the marketing of many 
potable use plumbing products in a way that communicates the lead free 
status of the products to the purchaser without the burden of 
regulatory requirements to do so.
    EPA expects that this final rule 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.

C. What is EPA's authority for taking this action?

    EPA's authority for this final rule is the Safe Drinking Water Act, 
42 U.S.C. 300f et seq. including sections 1417, 1445, 1450, and 1461 of 
the SDWA, 42 U.S.C. 300j-6, 300j-4, 300j-9, and 300j-21. The SDWA, 
section 1450, authorizes EPA Administrator to ``prescribe such 
regulations as are necessary or appropriate to carry out his 
functions'' under the SDWA. EPA's current regulations (40 CFR 141.43) 
codify parts of section 1417 of the SDWA, but they do not reflect the 
current version of section 1417, as amended by the RLDWA and the CFSA, 
or the introduction into commerce prohibitions, which were established 
in the 1996 amendments to the SDWA. This final rule amends those 
regulations to reflect current law. In addition, EPA is adopting 
additional regulatory provisions to aid in the implementation and 
enforcement of the requirements of the SDWA, section 1417, and to 
identify additional products as exempt.

D. What are the incremental costs and benefits of this action?

    EPA conducted an incremental compliance cost analysis of this final 
rule. For detail on the cost analysis see sections V and VI of this 
preamble. The Final Rule Technical Support Document (USEPA, 2020) 
prepared for this final rule is available in the docket for this rule. 
It contains the detailed economic analysis for this rule including the 
description of the cost assessment. EPA did not quantify or monetize 
benefits for this final rule, but a qualitative discussion of the 
benefits attributable to this final rule can be found in section VII of 
this preamble and in the Final Rule Technical Support Document.
    Total annualized costs for this final rule range from $7 million 
discounted at three percent to $12 million discounted at seven percent. 
These costs include administrative requirement costs, third party and 
self-certification costs, and the costs of responding to EPA data 
requests.
    This final rule will help ensure that only lead free plumbing 
products and components of public water systems are used in repairs and 
new installations in potable use applications. The benefits of this 
final rule are the resulting incremental reduction in exposure to

[[Page 54238]]

lead in drinking water. The 2013 Integrated Science Assessment for Lead 
(USEPA, 2013) and the U.S. Department of Health and Human Services' 
National Toxicology Program Monograph on Health Effects of Low-Level 
Lead (National Toxicology Program, 2012) have examined the health 
effects of lead. In these documents, lead has been associated with 
adverse cardiovascular effects (both morbidity and mortality effects), 
renal effects, reproductive effects, immunological effects, 
neurological effects, and cancer.

II. Background

    Lead can be introduced into drinking water by corrosion of plumbing 
products and components of public water systems (pipes, pipe and 
plumbing fittings, and fixtures, solder, and flux). The greatest risk 
associated with lead exposure is to infants, young children, and 
pregnant women. Scientists have linked lead exposure to lowered IQ in 
children, as compared with children exposed to lower levels of lead.
    In 1986, Congress amended the SDWA to prohibit the use of pipes, 
solder, or flux that are not ``lead free'' in the installation or 
repair of public water systems or plumbing in facilities providing 
water for human consumption. In doing so, Congress intended ``to 
eliminate the future use of lead in water supply distribution 
systems.'' H.R. Rep. No. 99-575 (1986) (Conf. Rep.) as reprinted in 
1986 U.S.C.A.A.N. 1592, 1602. At the time, the SDWA defined lead free 
as solder and flux having no more than 0.2 percent lead, and defined 
lead free pipes as having no more than 8.0 percent lead.
    In 1996, Congress further amended the SDWA to clarify that its 
``lead free'' prohibition on the use of pipes, solder, and flux also 
applies to pipe fittings, plumbing fittings, and fixtures (referred to 
in this document as ``fittings and fixtures''). The goal of the 
legislation was described similarly to the purpose articulated in the 
1986 legislative history: ``The focus of these changes is to prevent 
the contamination of the drinking water supply by lead that has leached 
from pipes, faucets, and other fixtures incidental to the delivery of 
potable water. It is the intent of the Committee that the terms pipe 
and plumbing fittings, and fixtures in the legislation are in reference 
to drinking water applications.'' H.R. Rep. 104-632(I), at 39, as 
reprinted in 1996 U.S.C.A.A.N.1366, 1402. The 1996 amendments also 
revised the definition of lead free to require new plumbing fittings 
and fixtures be in compliance with a lead leaching standard established 
in accordance with section 1417(e) of the SDWA.
    The 1996 amendments also made it unlawful for any person to 
introduce into commerce any pipe, pipe or plumbing fitting, or fixture 
that is not lead free, except for a pipe that is used in manufacturing 
or industrial processing. As amended in 1996 SDWA section 
1417(a)(3)(B), prohibits ``any person engaged in the business of 
selling plumbing supplies, except manufacturers, to sell solder or flux 
that is not lead free,'' and SDWA section 1417(a)(3)(C), makes it 
unlawful ``for any person to introduce into commerce any solder or flux 
that is not lead free unless the solder or flux bears a prominent label 
stating that it is illegal to use the solder or flux in the 
installation or repair of any plumbing of water for human 
consumption.''
    In 2011, Congress enacted the RLDWA. It revised the definition of 
lead free by lowering the allowable maximum lead content from 8.0 
percent to a weighted average of 0.25 percent of the wetted surfaces of 
plumbing products. It also revised the definition of lead free to 
include a statutory method for the calculation of lead content. 
Additionally, the RLDWA revised the definition of lead free to remove 
the requirement that new plumbing fittings and fixtures be in 
compliance with standards established in accordance with the SDWA, 
section 1417(e), for the leaching of lead from new plumbing fittings, 
and fixtures.
    The RLDWA also established two new categories of exemptions from 
the prohibitions on the use or introduction into commerce of pipes, 
pipe fittings, plumbing fittings or fixtures, solder or flux not 
meeting the statutory definition of lead free. One exemption is for 
pipes, pipe fittings, plumbing fittings, or fixtures, including 
backflow preventers, that are used exclusively for nonpotable services, 
such as manufacturing, industrial processing, irrigation, outdoor 
watering, or any other uses where the water is not anticipated to be 
used for human consumption (SDWA, section 1417(a)(4)(A)). A second 
exemption was established for toilets, bidets, urinals, fill valves, 
flushometer valves, tub fillers, shower valves, service saddles, or 
water distribution main gate valves that are 2 inches in diameter or 
larger (SDWA, section 1417(a)(4)(B)). The RLDWA established a 
prospective effective date of January 4, 2014, which provided a 3-year 
timeframe for affected parties to transition to the new requirements. 
The CFSA further amended SDWA section 1417, to exempt fire hydrants 
from the prohibitions otherwise applicable under that section.
    In anticipation of these changes taking effect, EPA released the 
``Summary of the Reduction of Lead Drinking Water Act and Frequently 
Asked Questions'' to help the public, including manufacturers, 
retailers, plumbers, and consumers in understanding the changes to the 
law (USEPA, 2013a). In this Frequently Asked Questions (FAQ) document, 
EPA stated its intention to further evaluate and refine topics in the 
FAQ and other issues in a future rulemaking.
    On January 17, 2017, EPA published in the Federal Register a 
proposed rulemaking--``Use of Lead Free Pipes, Fittings, Fixtures, 
Solder and Flux for Drinking Water'' (USEPA, 2017, 82 FR 4805). The 
proposed rulemaking contained several major provisions. EPA proposed to 
codify various statutory provisions, including the definition of lead 
free; the prohibition on introducing into commerce pipes, fittings, or 
fixtures that are not lead free; and the prohibition on the use of any 
such products in the installation or repair of any public water system 
or any plumbing in a residential or nonresidential facility providing 
water for human consumption. EPA also proposed labeling requirements to 
differentiate plumbing materials that are required to meet the lead 
free requirements from those that are exempt from the requirements. In 
addition, EPA proposed requirements that lead free products would need 
to be certified by an American National Standard Institute (ANSI) 
accredited third party certification body, unless they are made by 
manufacturers having fewer than 100 employees, in which case they could 
be self-certified as lead free. Other provisions were included in the 
proposal to aid in implementation, such as defining certain terms used 
in the statute or the proposed regulation and provisions to ensure 
compliance.
    In the Federal Register publication for the proposed rulemaking 
(USEPA, 2017, 82 FR 4805 (January 17, 2017)), EPA requested comments on 
a number of specific questions concerning provisions in the proposal 
and possible alternative provisions or criteria. In response to 
requests from the public, EPA extended the 90-day public comment period 
by an additional 30 days; the comment period closed on May 17, 2017 (82 
FR 17406, April 11, 2017). EPA received 25,858 comment submissions, of 
which 25,751 were identical or nearly identical because they were 
submitted as part of a mass mailing public comment campaign (5,212 of 
the 25,751 comments included

[[Page 54239]]

unique statements in addition to the identical comment). A detailed 
listing of public comments received and EPA's responses to comments are 
available in Docket ID EPA-HQ-OW-2015-0680 at https://www.regulations.gov.

III. Summary of Data Used

    This final rule is supported by a number of documents. The 
Technical Support Document and additional records are available in the 
public record for this final rule under Docket ID No. EPA-HQ-OW-2015-
0680 at https://www.regulations.gov.

A. Characterization of the Affected Industry

    EPA used a number of data sources in the characterization of the 
plumbing manufacturing industry. GMP Research, Inc., provided a report 
to EPA in 2014, which included data on the total number of both potable 
and nonpotable plumbing products sold in 2013, distributed across 40 
product subcategories, and the market share of the leading suppliers by 
each product subcategory that may be subject to EPA's final rule. These 
data were supplemented with information from various additional 
sources. Dun & Bradstreet data were obtained for those firms that were 
identified by the North American Industry Classification System (NAICS) 
and Standard Industrial Classification (SIC) code classifications as 
potentially producing products that would be affected by the final 
rule. Additional data for plumbing manufacturers and fabricators were 
obtained from ThomasNet, a comprehensive, online database that provides 
information on manufacturing firms in the United States. EPA also used 
NSF International's Certified Drinking Water System Components 
database, which provides a list of manufacturers who use NSF to certify 
their products to NSF/ANSI Standard 61, including the subset of 
products that are certified to Annex G of that standard to reflect the 
0.25 percent lead content limit, which was later established as a new 
NSF/ANSI Standard 372. Additional information was gathered from the 
website of the Plumbing Manufacturers International (PMI), a plumbing 
industry trade association. EPA used data on the number of employees 
and annual receipts for firms from the U.S. Census Bureau's Statistics 
of U.S. Businesses. Information used in the development of industry 
production growth was obtained from both the GMP Research, Inc., report 
and projections on United States housing growth from IHS Global 
Insight. These data sources are referenced in the Final Rule Technical 
Support Document and other supporting documents available in Docket ID 
No. EPA-HQ-OW-2015-0680 at https://www.regulations.gov.

B. Determining Baseline Industry Practices and Potential Costs of 
Compliance

    EPA conducted calls with representatives of both the PMI and the 
American Foundry Society (AFS) industry associations and held a 
stakeholder webinar in 2015 to obtain information on current practices 
within the plumbing parts manufacturing industry in regard to labeling 
of product packages, marking of the plumbing products themselves, and 
the technical feasibility and costs associated with making changes to 
product labeling and marking. Additionally, PMI and AFS provided 
information to EPA on product identification methods, including the 
estimated percentage of products that currently include lead free 
identification and general cost information for modifications to 
package labeling and product marking. Information on the feasibility 
and time requirements for changing production molds in response to 
potential regulatory requirements was also discussed, along with 
plumbing product inventory turnover rates. The trade associations also 
provided information on the use and costs of third party certification 
in the industry.
    In addition, EPA obtained data from various independent and 
geographically diverse tool and dye firms on the cost of mold 
modifications. EPA also contacted suppliers to obtain capital equipment 
and operations and maintenance (O&M) costs to allow the Agency to 
estimate the economic impact of potential new labeling requirements 
under the rule. EPA also contacted the eight firms currently accredited 
to certify plumbing components for compliance with NSF/ANSI Standard 
372, to obtain information on the cost of certification and the 
technical process for testing and certifying products to meet the 
standard. These calls with PMI and AFS and other data sources are 
referenced in the Final Rule Technical Support Document and other 
supporting documents available under Docket ID No. EPA-HQ-OW-2015-0680 
at https://www.regulations.gov.

IV. Final Rule

    This section includes a summary of the requirements of this final 
rule, the significant changes from the proposed rulemaking, and the 
rationale for those changes. A detailed listing of public comments 
received and EPA's responses to comments are available in Docket ID 
EPA-HQ-OW-2015-0680 at https://www.regulations.gov.

A. Applicability and Scope

1. Final Rule Requirements:
    This final rule amends the Code of Federal Regulations (CFR) at 40 
CFR part 143 by retitling it as Other Drinking Water Regulations; 
creating a subpart A, to consist of the existing National Secondary 
Drinking Water Regulations; and creating a Subpart B, Use of Lead Free 
Pipes, Fittings, Fixtures, Solder, and Flux for Drinking Water, 
pursuant to, inter alia, sections 1417, 1461, and 1450 of the SDWA. EPA 
has included a Scope/Applicability section in subpart B as 40 CFR 
143.10 of this final rule. Subpart B states that ``[t]his subpart 
establishes regulations pertaining to pipes, pipe or plumbing fittings, 
or fixtures, solder, or flux pursuant to, inter alia, section 1417 and 
1461 of the SDWA (42 U.S.C. 300g-6 and 300j-21). It applies to any 
person who introduces these products into commerce, such as 
manufacturers, importers, wholesalers, distributors, re-sellers, and 
retailers. It also applies to any person who uses these products in the 
installation or repair of a public water system or a residential or 
nonresidential facility providing water for potable uses.'' The product 
certification requirements in 40 CFR 143.19 for lead free pipes, 
fittings, and fixtures in this final rule apply to manufacturers and 
importers. The terms ``manufacturer'' and ``importer'' are defined in 
40 CFR 143.11. A manufacturer is defined as a person or entity who: 
Processes or makes a product; or has products processed or made under a 
contractual arrangement for distribution. An importer is any person who 
introduces into commerce any pipe, fitting, fixture, solder or flux 
entering the United States; or any ``importer'' as defined in 19 CFR 
101.1; or both. EPA does not consider plumbers or entities that design 
and build public water systems to be manufacturers of pipes, fittings, 
and fixtures, but rather as persons who use or assemble pipes, 
fittings, and fixtures in the installation or repair of a public water 
system or a residential or nonresidential facility providing water for 
potable uses. This final rule requires that new or replacement pipes, 
pipe or plumbing fittings, or fixtures, solder and flux used in 
providing water for potable uses must be lead free, except for certain 
exemptions.
    There are six components of the definition of ``lead free'' in 40 
CFR 143.12(a) through (f) of this final rule, based on the statutory 
definitions of lead free in sections 1417 and 1461 of

[[Page 54240]]

the SDWA. In 40 CFR 143.12(a), EPA specifies the maximum allowable lead 
content as follows: (1) Not containing more than 0.2 percent lead when 
used with respect to solder and flux; and (2) Not more than a weighted 
average of 0.25 percent lead when used with respect to the wetted 
surfaces of pipes, pipe fittings, plumbing fittings, and fixtures. In 
40 CFR 143.12(b), this final rule includes the statutorily prescribed 
calculation of the weighted average lead content. In 40 CFR 143.12(c) 
and (d), EPA specifies how to use the required calculation method when 
a coating or liner is used in manufacturing a product. (This final rule 
defines the terms ``coating'' and ``liner'' in 40 CFR 143.11.) 
Similarly, in 40 CFR 143.12(e), EPA specifies how to calculate lead 
content if a fixture consists of any media (e.g., activated carbon, ion 
exchange resin) contained in filters.
    In 40 CFR 143.12(f) of the final rule, EPA defines ``lead free'' 
for drinking water coolers. In addition to meeting the weighted average 
of 0.25 percent lead when used with respect to wetted surfaces, 
additional limits specific to drinking water coolers are placed on 
their storage tanks and individual parts or components, consistent with 
the definition of ``lead free,'' and applicable to drinking water 
coolers in section 1461(2) of the SDWA. This final rule addresses this 
requirement in 40 CFR 143.12(f) as follows: In addition to the 
definitions of ``lead free'' in 40 CFR 143.12(a) through (e), no 
drinking water cooler which contains any solder, flux, or storage tank 
interior surface, which may come into contact with drinking water is 
lead free if the solder, flux, or storage tank interior surface 
contains more than 0.2 percent lead. Drinking water coolers must be 
manufactured such that each individual part or component that may come 
in contact with drinking water shall not contain more than 8 percent 
lead while still meeting the maximum 0.25 percent weighted average lead 
content of the wetted surfaces of the entire product.
    As with all pipes, fittings, or fixtures, this final rule does not 
require the removal and replacement of existing drinking water coolers 
that do not meet the maximum 0.25 percent weighted average lead content 
of the wetted surfaces of the entire product. However, this final rule 
does require that if any new drinking water coolers are installed, or 
if existing drinking water coolers are removed and replaced, with a new 
or replacement device, the new and replacement products must meet the 
requirements of this final rule.
2. Changes From Proposed Rule and Rationale
    Some public commenters requested that EPA clarify that this final 
rule encompasses products such as those used in municipal drinking 
water distribution and plumbing products that convey drinking water. 
EPA added a new section, 40 CFR 143.10 Applicability and Scope, to this 
final rule to provide a brief description of the rule and to whom it 
applies. The statutory prohibition on the use or introduction into 
commerce of pipes, pipe and plumbing fittings, fixtures, solder and 
flux that are not lead free, and the corresponding requirements 
described in this final rule applies to any person. ``Person'' is 
defined under the SDWA to include individuals; corporations; companies; 
associations; partnerships; municipalities; or State, Federal, or 
Tribal agencies. The statutory ban on selling solder and flux that are 
not lead free applies only to ``any person engaged in the business of 
selling plumbing supplies.'' The use prohibition applies only to use in 
the ``installation or repair'' of: (1) Any public water system; or (2) 
any plumbing in a residential or nonresidential facility or location 
providing water for human consumption.
    Section 143.12(e) was added to this final rule to exclude media in 
filters, such as activated carbon, from the calculation used to 
determine the wetted surface area of the entire product. This change 
was made because such filter media should not contain lead, yet the 
surface area of the filter media would be very large and could be 
difficult to determine; therefore, including it in the calculation of 
the weighted average of the lead content of the product would allow 
other components in the product to contain high levels of lead while 
still meeting the definition of lead free.
    EPA requested comment concerning whether a specific provision 
needed to be included in this final rule to define ``lead free'' for 
drinking water coolers because of the different definitions in sections 
1417 and 1461 of the SDWA. EPA received several public comments about 
this issue, most of which supported the inclusion of a specific 
provision pertaining to drinking water coolers. This final rule 
includes 40 CFR 143.12(f) to address the specific treatment of drinking 
water coolers under the SDWA. Section 1461 of the SDWA defines lead 
free with respect to drinking water coolers to mean that ``each part or 
component of the cooler which may come into contact with drinking water 
contains not more than 8 percent lead except that no drinking water 
cooler that contains any solder, flux or storage tank interior surface 
that may come into contact with drinking water shall be considered lead 
free if the solder, flux, or storage tank interior surface contains 
more than 0.2 percent lead.'' The SDWA, section 1461(2), also 
authorizes the Administrator to establish more stringent requirements 
for treating any part or component of a drinking water cooler as lead 
free ``whenever he determines that any such part may constitute an 
important source of lead in drinking water.'' A drinking water cooler 
is a ``fixture'' under this final rule and as that term is generally 
understood; and, therefore, subject to the definition of lead free in 
the SDWA, section 1417. The ``parts or components'' in drinking water 
coolers constitute an important source of lead in drinking water 
coolers. Accordingly, this final rule defines ``lead free'' for 
drinking water coolers to give effect to both statutory definitions of 
lead free. In practice, drinking water coolers need to comply with the 
most restrictive of the requirements in sections 1417 and 1461 of the 
SDWA. For clarity and consistency with statutory requirements, EPA 
addressed the requirements of the SDWA, section 1461, in this final 
rule by including regulatory text in 40 CFR 143.12(f). If the section 
1461 requirements were not incorporated into this rule, a drinking 
water cooler could potentially have a small part with lead content that 
is much greater than 8 percent as long as the weighted average lead 
content of wetted surfaces of the whole device did not exceed 0.25 
percent lead. The effect of this change in the rule is to further 
reduce potential public exposure to lead from any new or replacement 
drinking water coolers.
    Based on public comment, this final rule includes a minor 
correction to address concerns with placement of the rule in 40 CFR 
part 143 as it relates to the mandatory nature of this rule. The 
National Secondary Drinking Water Regulations that are currently 
already in 40 CFR part 143 are not federally enforceable as stated in 
existing 40 CFR 143.1. This final rule revises 40 CFR part 143 to 
designate the National Secondary Drinking Water Regulations as subpart 
A of part 141 and the lead free requirements in this rule as subpart B. 
Therefore, EPA also revised the statement about non-enforceability in 
40 CFR 143.1, to clarify it only pertains to the National Secondary 
Drinking Water Regulations by removing ``part'' and

[[Page 54241]]

replacing it with ``subpart'' in the first sentence of the paragraph.

B. No Labeling Requirement for Potable Use Products

1. Final Rule Requirements
    This final rule does not require any marking or labeling of lead 
free pipes, fittings, or fixtures on products or packages. However, EPA 
continues to recommend marking and labeling of lead free products and 
packages to indicate compliance with the SDWA, section 1417.
2. Changes From Proposed Rule and Rationale
    EPA proposed to require that all lead free products be labeled on 
the package, container or tag, as well as marked directly on the 
product, unless the product is too small for a legible marking. EPA did 
not propose a specific phrase to be required on products or packages, 
but rather a performance standard--that each package, and each product 
(unless the product is too small), clearly convey to users that the 
product is in compliance with the lead free requirements of the SDWA.
    EPA is not requiring any lead free labeling or marking of potable 
products in this final rule. Several commenters made the point that 
labeling is not necessary if third party certification is required, 
because the certification itself provides adequate assurance of 
compliance and, therefore, the cost of labeling is not worth any 
incremental benefits of labeling a product that has been verified as 
lead free. EPA found that many manufacturers already utilize a 
combination of product marking and/or package labeling to indicate that 
the product has been certified to be lead free for marketing reasons 
and to demonstrate that the products can be used in compliance with 
State and local plumbing codes. EPA anticipates that this final rule's 
certification provisions, combined with the widespread practice of 
voluntary labeling by firms that obtain third party certification, will 
likely result in the marketing of many potable use plumbing products in 
a way that communicates the lead free status of the product to the 
purchaser without the burden of regulatory requirements to do so. 
Accordingly, the final rule does not require the marking and labeling 
of lead free pipes, fittings, or fixtures.

C. Exemptions

1. Used Exclusively for Nonpotable Services
a. Final Rule Requirements
    The RLDWA established two new categories of exemption from the lead 
free requirements. One category exempts pipes, pipe fittings, plumbing 
fittings, or fixtures that are ``used exclusively for nonpotable 
services such as manufacturing, industrial processing, irrigation, 
outdoor watering, or any other uses where the water is not anticipated 
to be used for human consumption.'' EPA has also provided examples of 
products that could be considered as ``used exclusively for nonpotable 
services'' in 40 CFR 143.16(a). The second exemption category consists 
of specifically named product classes. These specifically listed exempt 
products are codified in this final rule and discussed in section 
IV.C.2. of this preamble.
b. Changes From Proposed Rule and Rationale
    EPA has removed the definition of ``used exclusively for nonpotable 
services'' that was contained in the proposed rulemaking. The proposed 
regulation had defined the term ``used exclusively for nonpotable 
services'' by specifying two ways to meet this exemption: (1) The 
product is incapable of use in potable services (e.g., is physically 
incompatible with other products that would be needed to convey water 
for potable uses); or (2) The product is clearly labeled, on the 
product, package, container, or tag with a phrase such as ``Not for use 
with water for human consumption'' or another phrase that conveys the 
same meaning in plain language. In the final rule, as opposed to 
defining the term ``used exclusively for nonpotable services,'' EPA has 
provided examples of products that could be considered as ``used 
exclusively for nonpotable services'' in 40 CFR 143.16(a).
    EPA received numerous comments on the proposed definition with a 
very wide range of perspectives, examples of which are summarized in 
this section. Some commenters supported the definition as proposed, 
with some stating the requirement is critical to human health. Some 
commenters requested EPA remove the option of qualifying for the 
exemption through labeling products with a warning, and instead require 
such products be made physically incompatible with potable water 
plumbing. Other commenters stated that many fittings and components, 
such as automotive parts and HVAC valves, are physically compatible 
with potable use plumbing products because the pipe threads are 
compatible and that to extend the labeling requirement to anything 
which could be made to fit onto a potable use plumbing product would 
drastically increase the rule cost to many manufacturing sectors. Other 
commenters contended that EPA has no authority to regulate non-potable 
use products or that such a requirement was beyond the intent of the 
SDWA. EPA's proposed option to allow the use of labeling to qualify for 
the ``used exclusively for nonpotable services'' exemption was not a 
requirement to label exempt products; it was an option EPA proposed be 
made available to manufacturers that elected to use it in order to 
establish that pipes, fittings, and fixtures intended, designed and 
marketed for use in nonpotable services or in applications other than 
delivery of water products would be considered ``used exclusively for 
nonpotable services'' and therefore exempt from the prohibitions. It 
would have been within EPA's authority to finalize such a requirement 
in order to clarify the meaning of the exemption for regulated 
entities. However, due to the numerous and widely differing 
perspectives and reasons expressed by commenters, it became clear that 
the definition could be interpreted to be both over-inclusive and 
under-inclusive. Therefore, in the final rule EPA is not including a 
definition of ``used exclusively for nonpotable services'' but EPA is 
providing examples of products that could be eligible for the 
exemption. These examples are not intended to create binding criteria 
for eligibility (or ineligibility) for the exemption. Therefore, EPA 
will continue to rely on manufacturers and importers, in the first 
instance, to determine which products are ``used exclusively for 
nonpotable services.'' Because any person, including a manufacturer or 
importer, could be subject to enforcement if the person introduces into 
commerce non-lead free products that could be used in potable services, 
it is in such person's interest to make accurate determinations about 
the potential use of their products in order to maintain compliance 
with the SDWA. As previously discussed, EPA recognizes that situations 
exist in which a particular product's primary use in most circumstances 
is expected to be for nonpotable use, but in which the same product may 
be anticipated to be used for potable use in some circumstances. 
Examples may include hose bibs and yard hydrants. The primary use of 
these products in most situations is likely outdoor watering and 
irrigation. However, they are sometimes observed to be installed and in 
use as a source of potable water for cooking and drinking, such as in 
campgrounds and RV parks. If used for cooking or drinking, the products 
are not used exclusively for nonpotable services. To

[[Page 54242]]

protect public health, EPA advises that manufacturers exercise caution 
in anticipating how a product that is introduced into commerce may be 
used in various circumstances. Likewise, EPA advises caution in 
anticipating product usage by persons involved in the installation or 
repair of any public water system, or of any plumbing in a residential 
or nonresidential facility providing water for human consumption. For 
non-lead free products that are very similar in form to, and that may 
be confused with, lead free potable use counterparts, EPA recommends 
that manufacturers, importers, and other suppliers either reformulate 
the product to be lead free or clearly label the non-lead free product 
with a phrase such as ``Not for use with water for human consumption.''
2. Specifically Listed Exempt Products
a. Final Rule Requirements
    This final rule codifies the statutory exemption for specific 
products by name in the SDWA, section 1417(a)(4)(B), to include 
toilets, bidets, urinals, fill valves, flushometer valves, tub fillers, 
fire hydrants, shower valves, service saddles, and water distribution 
main gate valves that are 2 inches in diameter or larger. In addition 
to the specific plumbing devices excluded in the SDWA, the final rule 
is also excluding clothes washing machines, emergency drench showers, 
emergency face wash equipment, eyewash devices, fire suppression 
sprinklers, steam capable clothes dryers, and sump pumps because these 
products are not designed or used for any potable application as 
potable uses as defined for this final rule. These products do not 
provide water for human ingestion. The Use Prohibitions in 40 CFR 
143.13 or the Introduction into Commerce Prohibitions in 40 CFR 143.15 
do not apply to these specifically exempted products; therefore, these 
exempt products do not need to meet the definition of lead free in 40 
CFR 143.12, and manufacturers and importers of these products do not 
need to meet the certification provisions in 40 CFR 143.19.
b. Changes From Proposed Rule and Rationale
    For the specific product exemptions listed in 40 CFR 143.16(b) and 
(c), EPA retained the exempted products listed in the proposed 
rulemaking either because they are explicitly identified as exempt in 
statute or because the product is not used for any potable purpose. In 
this final rule, EPA added two product categories to the list of exempt 
products as follows: ``emergency face wash equipment'' and ``steam 
capable clothes dryers.''
    Emergency face wash equipment may be combined with eyewash devices, 
and neither the equipment nor the devices are used for a potable 
purpose that involves the ingestion of water. Steam capable clothes 
dryers, like clothes washing machines, are used for laundering 
clothing; they are not used for the ingestion of water, and, therefore, 
are not used for any potable purpose as defined in this final rule.
    EPA is clarifying in this final rule that exempt products do not 
need to comply with the certification provisions of 40 CFR 143.19. Such 
products either (A) are not potable use products or (B) are 
specifically exempted by the RLDWA.

D. Product Certification

1. Final Rule Requirements
    The final rule establishes certification requirements for 
manufacturers and importers to demonstrate that the maximum lead 
content of the wetted surfaces of their plumbing products (i.e., pipes, 
fittings, and fixtures) does not exceed a weighted average of 0.25 
percent using the method for the calculation of lead content specified 
in this final rule. This final rule requires manufacturers with 10 or 
more employees, and importers entering products purchased from or 
manufactured by manufacturers with 10 or more employees, to obtain 
third party certification by an ANSI accredited third party 
certification body to demonstrate that, with some exceptions, any pipe, 
pipe or plumbing fitting or fixture introduced into commerce meets the 
definition of lead free. This final rule requires manufacturers with 
fewer than 10 employees, and importers entering products purchased from 
or manufactured by manufacturers with fewer than 10 employees, to 
demonstrate compliance either through third party certification by an 
ANSI accredited certification body or through self-certification as 
described later in this section. This final rule also requires 
manufacturers of all sizes and importers entering goods manufactured by 
or purchased from entities of all sizes to certify custom fabricated 
products either through an ANSI accredited certification body or 
through self-certification as described later in this section. A 
requirement for recordkeeping pertaining to product certification is 
described in section IV.E.2. of this preamble.
    Third party certified plumbing materials in covered plumbing 
projects are currently required for certain products under model 
plumbing codes, which are often adopted in whole or in part by States 
or municipalities. The most recent version of the single most widely 
adopted model plumbing code, the 2018 International Plumbing Code 
(published in 2017), requires pipe, pipe fittings, joints, valves, 
faucets, and fixture fittings used to supply water for drinking or 
cooking purposes to comply with the NSF/ANSI 372 standard for lead 
content. To meet the NSF/ANSI 372 standard, a product needs to be 
evaluated by an ANSI accredited third party certification body. These 
bodies are independent organizations that test a product, review a 
product's manufacturing process, and determine whether the product 
complies with specific standards for safety, quality, sustainability, 
or performance (e.g., NSF/ANSI 372 standard for lead content). ANSI 
accredited third party certification bodies currently include NSF 
International, CSA Group, ICC Evaluation Services, International 
Association of Plumbing and Mechanical Officials Research & Testing 
(IAPMO R&T), Intertek Testing Services, Truesdail Laboratories, 
Underwriters Laboratories, and the Water Quality Association.
    For manufacturers with fewer than 10 employees and importers 
entering products manufactured by or purchased from manufacturers with 
fewer than 10 employees, this final rule provides the flexibility of 
allowing these entities to demonstrate product compliance either by 
using an ANSI accredited third party certification body or by self-
certification of the products. Firms with fewer than 10 employees are 
more likely to operate on a limited scale with a lower volume of 
production, including those that serve only local or regional markets, 
which would make third party certification not as cost effective as it 
is for larger firms; the cost of certification per unit produced could 
be much higher.
    Therefore, this final rule provides the option for firms with fewer 
than 10 employees to self-certify their products. Those eligible 
manufacturers that opt for the self-certification are required to 
develop a ``certificate of conformity'' to attest that products meet 
the lead free requirements. A similar concept is currently in use for 
certain products regulated by the Federal Communications Commission and 
the Consumer Products Safety Commission.
    For manufacturers and importers eligible for self-certification, 
this final rule requires the certificate of conformity to be posted to 
a website with continuing public access in the

[[Page 54243]]

United States, unless it is distributed by other means (e.g., 
electronically or in hard copy) with the product through the 
distribution channel for final delivery to the end use installer of the 
product.
    The certificate of conformity is required to include the following 
information: Contact information for the manufacturer and any importer, 
a listing of products, statements attesting that the products meet the 
lead free requirements and that the manufacturer's or importer's 
eligibility to self-certify the product is consistent with the 
regulation (e.g., the manufacturer has fewer than 10 employees or the 
product is custom fabricated), a statement indicating how the 
manufacturer or importer verified conformance, and signatory 
information. The statement indicating how the manufacturer or importer 
verified conformance could be a brief overview of the general 
methodology employed, such as: laboratory testing using X-ray 
fluorescence, other specific technologies, or confirmation (by some 
method described in the statement) that all source materials used in 
manufacture were less than 0.25 percent lead. EPA anticipates that 
firms will develop the certificate of conformity to work best with 
their individual circumstances. For example, a manufacturer may list 
multiple product numbers or models on a certificate of conformity for 
use with all products within a similar product family, provided that 
all of the similar products meet the lead free requirements.
    EPA anticipates that some firms having fewer than 10 employees will 
utilize third party certification rather than self-certification in 
cases where a large quantity of a specific product is produced. Some 
firms will do so because many State and local plumbing codes require 
the use of third party certified plumbing products in projects covered 
by the codes.
    This final rule also requires firms that expand to 10 or more 
employees to obtain third party certification within 12 months, to 
allow a reasonable transition time for obtaining third party 
certification of products. Third party certification should be easily 
attainable in such situations without the need to modify or reformulate 
products if the products were accurately self-certified as lead free.
    The certification requirement will help ensure that only lead free 
plumbing materials are introduced into commerce or used in new 
installations or repairs of any public water system or any plumbing in 
a facility providing water for human consumption. The third party 
certification requirement leverages the resources of the third party 
certification bodies as well as manufacturers to help parties in the 
supply chain ensure that they are not violating the requirements of the 
RLDWA when they introduce the product into commerce or use it in new 
installations or repairs. Increasing the number of products that are 
third party certified will provide small businesses such as plumbers 
and builders better assurance that they are complying with the federal 
requirements to use lead free plumbing products. The self-certification 
requirement, which is applicable to manufacturers with fewer than 10 
employees or for custom fabricated products, also helps to ensure that 
products sold by those smaller manufacturers or those products that are 
custom fabricated are lead free without imposing a significant burden 
on the smallest manufacturers.
    This final rule also allows any manufacturer of custom fabricated 
products to opt for self-certification for custom fabricated products. 
EPA has defined ``custom fabricated product'' in 40 CFR 143.11. For 
custom fabricated products, EPA anticipates that firms may develop and 
use a certificate of conformity that covers a range of products within 
a product family, provided that all the products meet the lead free 
requirements.
    This final rule includes three exclusions from the certification 
requirement for those products required to be lead free: (A) Product 
components of assembled pipes, fittings, or fixtures do not need to be 
individually certified if the entire product in its final assembled 
form is lead free certified; (B) direct replacement parts for 
previously installed lead free certified products do not need to be 
individually certified if the weighted average lead content of the 
wetted surface area for the part does not exceed the weighted average 
lead content of the original part; and (C) dishwashers.
2. Changes From Proposed Rule and Rationale
    In the proposed rulemaking, EPA proposed certification requirements 
for manufacturers and importers to demonstrate that the maximum lead 
content of the wetted surfaces of their plumbing products do not exceed 
a weighted average of 0.25 percent, using the method for the 
calculation of lead content established in the statute. For products 
that are required to meet the SDWA section 1417 lead free requirements, 
EPA proposed to require manufacturers with 100 or more employees or 
importers sourcing products from or representing manufacturers with 100 
or more employees to demonstrate compliance with the lead free 
definition by obtaining third party certification by an ANSI accredited 
third party certification body. EPA proposed to require manufacturers 
with fewer than 100 employees, or importers sourcing products from or 
representing foreign manufacturers with fewer than 100 employees, to 
demonstrate compliance either through third party certification by an 
ANSI accredited certification body or through self-certification as 
described later in this section. As evidenced by California's product 
testing program, there has been significant noncompliance with 
California's definition of lead free, which was the basis of the RLDWA 
lead free definition (CalEPA, 2013). A third party certification 
requirement leverages the resources of the third party certifiers as 
well as the supply chain to help the market police itself and assure 
compliance. This final rule also lowers the maximum number of employees 
allowed for a manufacturer or importer to self-certify products to 
apply to manufacturers with fewer than 10 employees, and importers 
entering products purchased from or manufactured by manufacturers with 
fewer than 10 employees.
    EPA made this change after taking into consideration issues raised 
in public comments regarding both the proposed requirements for 
labeling and marking (pertaining to section IV.B of this preamble) and 
the proposed requirements for self-certification. After careful review 
of comments, EPA determined that the objectives achieved through 
labeling and marking can more effectively be achieved through requiring 
more widespread use of third party product certification. EPA proposed 
labeling and marking requirements with the intent of clearly conveying 
to users that a product is in compliance with the lead free 
requirements of the SDWA. However, the third party certification 
requirement assures users in the supply chain that they are not 
violating the requirements of the RLDWA when they introduce a product 
into commerce or use it in new installations or repairs. Thus, the 
final rule does not require any marking or labeling of lead free pipes, 
fittings, or fixtures on products or packages. Rather, this objective 
of the rule is achieved by relying more heavily on third party 
certification.
    EPA is ensuring that there will not be a significant impact on 
small entities by allowing the self-certification option for firms with 
fewer than 10 employees or for any custom fabricated product.

[[Page 54244]]

Reducing the employee threshold for self-certification from less than 
100 employees in the proposed rulemaking to less than 10 employees in 
the final rule, will reduce the number of self-certified products in 
the market. EPA chose this cut-point to avoid imposing a burden on the 
smallest firms that would be disproportionate to the incremental 
benefits of third party certification as compared to self-
certification. The employee threshold of 100 would have allowed a much 
larger share of the market to avoid third party certification, reducing 
the benefits of a widely applicable regulatory requirement for third 
party certification. Increasing the number of products that are third 
party certified will provide small businesses such as plumbers and 
builders better assurance that they are complying with the federal 
requirements to use lead free plumbing products. The self-certification 
requirement, which is applicable to manufacturers with fewer than 10 
employees or for custom fabricated products, also helps to ensure that 
products sold by those smaller manufacturers or those products that are 
custom fabricated are lead free without imposing a significant burden 
on the smallest manufacturers.
    EPA received a number of comments supporting a requirement for 
third party certification of products and opposing any provisions 
allowing for self-certification. The comments opposing any self-
certification were submitted from a wide range of sources (e.g., 
plumbing manufacturing industry representatives, public water system 
interests, consumer advocacy groups, and individuals). Many of these 
comments object to the use of manufacturer size or employee numbers as 
a criterion for self-certification for various reasons. Many of these 
comments state that because many plumbing codes require the use of 
third party certified products, many firms with less than 100 employees 
presumably already have their products certified by a third party in 
order to be in conformance with plumbing codes and sell in these areas. 
For example, the most recent version of the model plumbing code, the 
2018 International Plumbing Code, requires pipe, pipe fittings, joints, 
valves, faucets, and fixture fittings used to supply water for drinking 
or cooking purposes to comply with the NSF/ANSI 372 standard for lead 
content. As a result, products sold in States or municipalities that 
have adopted such a model plumbing code are likely to be certified, 
regardless of the size of the firm.
    Some commenters stated that small businesses that had already 
committed to third party certification of their products would be 
harmed by competitors that undercut prices by self-certifying products. 
Other comments expressed concern that a small entity exemption from 
third party certification could lead to abuse by over-seas providers 
that already present a more challenging category of manufacturer for 
regulators to monitor and that this could harm U.S. manufacturers. 
Thus, those commenters believe that there is no need to allow firms 
having fewer than 100 employees to self-certify their products and that 
doing so would create unfair market conditions and the introduction of 
products that are not lead free.
    Some commenters addressing the proposed product label and marking 
requirements, indicated that EPA should not require product labeling or 
marking, but rather should rely more heavily on third party 
certification to implement the intent of the rule. Several commenters 
made the point that labeling is not necessary if third party 
certification is required, because the certification itself provides 
adequate assurance of compliance and, therefore, the cost of labeling 
is not worth any incremental benefits of labeling a product that has 
been verified as lead free. One comment states opposition to any use of 
self-certification but indicates that if EPA nevertheless allows self-
certification in some cases, it should do so at a lower employee 
threshold to reduce the volume of products eligible to be self-
certified. This commenter asserts that as proposed, almost one fifth of 
the total volume of products produced would be eligible to be self-
certified. In contrast, very few comments requested that self-
certification be allowed for any firm and only one comment suggested a 
higher employee threshold level be specified. Of the very few comments 
that cited a need for self-certification, almost all suggested the use 
of criteria such as product characteristics (e.g., product complexity 
or type of material) rather than employee numbers to determine 
eligibility.
    In making this change to the size of the firms that are eligible 
for self-certification from firms with fewer than 100 employees to 
firms with fewer than 10 employees, EPA has considered these comments 
and has also sought to avoid significant burdens upon the smallest 
plumbing manufacturers, those with less than 10 employees. EPA made 
this decision in tandem with the decision to not require the marking 
and labeling of lead free pipes, fittings, or fixtures as EPA had 
initially proposed. EPA anticipates that the certification provisions 
in the final rule, which increase the volume of third party certified 
products, combined with the widespread practice of voluntary labeling 
by firms that obtain third party certification, will likely result in 
the marketing of more potable use plumbing products in a way that 
communicates the lead free status of the product to the purchaser 
without the burden of regulatory requirements for labeling.
    EPA analyzed the costs of requiring third party certification for 
all firms regardless of the number of employees. Based on this analysis 
of the costs, EPA determined that requiring third party certification 
for all manufacturers would have resulted in a significant impact upon 
a substantial number of small manufacturers. Therefore, EPA is not 
requiring third party certification for all size firms. EPA 
specifically requested comment on the appropriate break point for 
number of employees, e.g., based on other categories of Census Bureau's 
Statistics of U.S. Business, for allowing self-certification. Census 
Bureau statistics include firm size categories for less than the 
following number of employees: 500, 100, 20, 10, and 5. EPA evaluated 
each of these potential firm size category break points. A summary of 
this analysis is included in the Final Rule Technical Support Document, 
Section 6.4 (USEPA, 2020). Based on this cost analysis, EPA determined 
that the most appropriate break point for self-certification 
eligibility is firms having fewer than 10 employees, which avoids 
significant impacts on small manufacturers.
    Manufacturers having fewer than 10 employees often may serve only 
local or regional markets and are more likely to operate on a limited 
scale with a low product volume per firm, reducing the cost 
effectiveness of third party certification. EPA determined that the use 
of this break point would not be expected to result in significant cost 
impacts--i.e., costs exceeding 1 percent of revenues for any small 
businesses. In comparing this impact to that of the proposed 
rulemaking, EPA found that the proposed rulemaking would have impacted 
29 small entities (2% of the total number of small entities) with costs 
exceeding 1 percent of revenues, whereas the final rule is expected to 
impact no small entities (0% of small entities) with costs exceeding 1 
percent of revenues. Note that the 1 percent of revenue threshold is 
based on EPA's Regulatory Flexibility Act guidance and represents a 
revenue level that if exceeded could result in a significant impact on 
a small business. However, if

[[Page 54245]]

third party certification had been required for all firms regardless of 
the number of employees, and assuming no product marking or labeling 
were required, EPA projected that 37 percent of small businesses would 
have been impacted with costs exceeding 1 percent of revenues. EPA 
estimated that manufacturers of covered products having fewer than 10 
employees account for 39 percent (representing 855 manufacturers) of 
the total number of such manufacturers (2,193 manufacturers), but only 
produce 1 to 2 percent of the total volume of products. In contrast, 
EPA estimated that manufacturers of covered products having fewer than 
100 employees account for 72% of the total number of such manufacturers 
and produce an estimated 5 to 18 percent of total product volume. EPA 
did not find that the economic impacts on firms with fewer than 10 
employees would justify the incremental benefits of third party 
certification for the estimated 1 to 2 percent volume of covered 
products produced by these firms. EPA determined that, for these firms, 
the option to self-certify in the final rule is effective in assuring 
lead free products are produced, because many of the firms with fewer 
than 10 employees may operate in limited local or regional markets, may 
be custom fabricators, or may be assemblers of products made from 
certified components.
    This final rule includes the addition of a provision specifying 
that any manufacturer or importer, regardless of employee numbers, is 
eligible to self-certify custom fabricated products rather than 
obtaining certification from an accredited third party certification 
body. For clarity, a definition of ``custom fabricated product'' is 
included in 40 CFR 143.11 of this final rule. EPA requested comment in 
the proposal concerning whether self-certification should be allowed as 
an option based on whether a product is mass produced or custom 
fabricated. EPA received one comment stating that self-certification 
should be allowed for custom fabricated products and that custom 
fabrication should be defined. In evaluating the comment, EPA 
determined that third party certification for custom fabricated 
products is impractical because obtaining the certification could take 
significant time and custom fabricated products are often needed for 
repairs when there is no existing product available for use. Moreover, 
third party certification for custom fabricated products is not as cost 
effective as it is for mass produced products; the cost per unit 
produced would almost certainly be much higher for custom fabricated 
products. Therefore, the final rule allows self-certification for any 
custom fabricated product (that meets the definition of such a product 
defined in this final rule) regardless of the firm's number of 
employees.
    In the proposed rulemaking, manufacturers and importers using the 
self-certification process would have been required to post the 
certificate of conformity on a website with continuing public access in 
the United States. In this final rule, manufacturers and importers may 
elect to distribute an electronic or hard copy version of the 
certificate of conformity through the distribution channel for final 
delivery to the end use installer of the product if it is not posted to 
a website. EPA has provided this flexibility in the final regulation to 
firms with fewer than 10 employees, because EPA determined that some 
firms with fewer than 10 employees do not maintain a website. For 
administrative ease, the final rule provides this flexibility to all 
manufacturers and importers who use the self-certification process for 
custom fabricated products as well. In addition, providing a copy of 
the certificate of conformity to end use installers is also an 
effective means of communicating the lead free status of a product to 
all the parties in the supply chain. A public comment requested the 
need for EPA to specify a transition period for entities that may 
expand their number of employees to greater than the level allowable to 
self-certify products, and therefore would be no longer eligible for 
self-certification of non-custom fabricated products. Based on the 
comment, EPA included a provision in 40 CFR 143.19(c)(1) to provide for 
a 12 month transition period of time.
    Three provisions were added to this final rule to allow certain 
exclusions from the certification requirement for those products 
required to be lead free. These products excluded from certification 
requirements include: (A) Product components of assembled pipes, 
fittings, or fixtures do not need to be individually certified if the 
entire product in its final assembled form is lead free certified; (B) 
direct replacement parts for previously installed lead free certified 
products do not need to be individually certified if the weighted 
average lead content of wetted surface area for the part does not 
exceed the weighted average lead content of the original part; and (C) 
dishwashers.
    EPA added the first two provisions in response to comments that the 
RLDWA recognizes the concept of area weighted average lead content, 
and, therefore, that the third party certification requirements apply 
only to the entire final end use product assembly and not individual 
sub-components, including any repair parts or repair kits. EPA agrees 
with commenters that the method for calculating lead content in the 
statutory definition of lead free contemplates that an assembled 
product could satisfy the requirement even if some components of the 
assembled product would exceed the maximum weighted average lead 
content of 0.25 percent if they were evaluated separately. Similarly, 
EPA agrees with commenters that certification of direct replacement 
parts for previously installed lead free certified products is 
unnecessary, provided that the lead content of the wetted area for the 
replacement part does not exceed such lead content of the original 
part. EPA has added the third provision excluding dishwashers from 
certification requirements based on consideration of information 
provided in public comment. In the proposal, EPA solicited comment on 
the product certification provisions of the proposed rulemaking and 
asked if any product certification should be required. A commenter 
opposed mandatory third party/self-certification requirements, stating 
they were unnecessary for home appliances, including dishwashers. The 
commenter provided information from manufacturers representing about 
80% of the dishwashers shipped in 2013. EPA had examined this 
information previously and concluded that ``dishwashers as a class 
appear to easily meet the definition of lead free (a weighted average 
of 0.25%)'' for wetted surfaces. The commenter also stated that the 
water film remaining on dishes at the end of the rinse cycle of a 
dishwashing machine is minimal. The commenter argued that the 
information provided should support an exemption from the requirements 
of the rule. After considering this information, EPA has determined 
that certification is not warranted to confirm that dishwashers are in 
compliance with the lead free requirements of the Reduction of Lead in 
Drinking Water Act. In view of the information previously submitted to 
EPA in 2013 about component materials used and the comparative surface 
areas of the components in dishwashers, the Agency has determined that 
it is not necessary for a manufacturer to undertake a certification 
process to demonstrate that these devices meet the lead free 
requirements. EPA also notes that exposure to water remaining on items 
cleaned in a dishwasher is relatively low in comparison to other

[[Page 54246]]

potable use products. EPA agrees with the commenter that the water film 
remaining on dishes at the end of the rinse cycle of a dishwashing 
machine is minimal and reduces the risk of exposure to lead resulting 
from water remaining on washed items that may be ingested. In addition, 
due to the large surface area of low-lead components (e.g., the plastic 
or stainless steel tub), it is unlikely for dishwashers to exceed the 
RLDWA lead limit compared with other potable use product types. Even if 
other component parts, such as fittings, were to contain lead, these 
components have a minor surface area compared with the wetted surface 
of the entire dishwasher device, which is consistent with the 
conclusion noted above that dishwashers as a class appear to easily 
meet the maximum weighted average lead content threshold of 0.25 
percent. Therefore, the final rule provides an exclusion from product 
certification requirements for dishwashers.
    EPA contacted eight ANSI accredited certification bodies prior to 
publication of the proposed rulemaking to obtain estimated cost for 
certifying products to ANSI/NSF Standard 372 and to obtain information 
on any time limits on the validity of the certification before renewal 
would be required by the certifying bodies. As EPA explained in the 
proposed rulemaking, while the period of time before the expiration of 
a certificate varies among certification bodies, the longest period of 
time is five years (USEPA, 2017; 82 FR 4817, January 17, 2017). 
Accordingly, EPA chose the minimum document retention time of five 
years from the date of last sale so as to be consistent with the 
maximum effective duration time for a third party product 
certification.

E. Other Regulatory Requirements and Clarifications

1. Definitions
a. Final Rule Requirements
    To clarify the requirements, set forth in the RLDWA and this final 
rule, EPA defined terms in 40 CFR 143.11 such as ``pipes,'' 
``fittings,'' ``fixtures,'' ``solder,'' ``flux,'' and several 
subcategories of these components, which are terms used in the statute, 
but are not defined within section 1417 of the SDWA. EPA included these 
and other definitions to provide clarity to provisions of this final 
rule. Other terms defined in this final rule include: ``accredited 
third party certification body,'' ``Administrator,'' ``affiliated,'' 
``alloy,'' ``coating,'' ``custom fabricated product,'' ``drinking water 
cooler,'' ``importer,'' ``introduce into commerce,'' ``lead free,'' 
``liner,'' ``manufacturer,'' ``nonpotable services,'' ``person,'' 
``pipe fitting,'' ``plumbing fitting,'' ``point-of-use treatment 
device,'' ``potable uses,'' ``product,'' ``public water system,'' 
United States,'' and ``water distribution main.'' EPA defines 
``product'' to mean a pipe, fitting, or fixture. This term was defined 
to reduce the number of repetitive references to pipes, fittings, and 
fixtures that would otherwise be necessary throughout this final rule. 
For similar reasons of conciseness, EPA defined ``fitting'' to mean a 
pipe fitting or plumbing fitting.
    By removing section 1417(d)(3) from the definition of lead free in 
the 2011 amendments to the SDWA, Congress eliminated distinctions 
between ``pipes,'' ``pipe fittings,'' ``plumbing fittings,'' and 
``plumbing fixtures.'' As a general matter, EPA finds that Congress 
intended that the prohibitions in Section 1417 broadly apply to pipes 
and plumbing materials that may provide water for human consumption 
with the goal of minimizing or eliminating lead in the wetted surfaces 
of these conveyances, thus reducing exposures to lead in tap water. 
Therefore, in the case of the definitions of ``fixture,'' ``pipe 
fitting,'' and ``plumbing fitting,'' this final rule contains broad 
working definitions that also include illustrative examples of these 
plumbing and water system products. EPA included some plumbing 
appliances or devices, such as drinking water coolers, water heaters, 
and water pumps, as examples in the definition of ``fixture.'' EPA did 
so because these products are often used in systems that supply potable 
water. These examples in the definitions are not intended to limit or 
exclude other types of pipes, fittings, or fixtures that are not 
specifically listed.
b. Changes From Proposed Rule and Rationale
    Additional definitions were added to this final rule for clarity. 
These definitions included ``point of use treatment device'' and 
``public water system,'' because these terms are defined in 40 CFR part 
141, where this final rule was previously located, but would not 
otherwise be defined in 40 CFR part 143, subpart B.
    ``Water meters'' were added to the list of example products 
included in the definition of ``fixture'' to clarify that these in-line 
devices comprising numerous internal parts are required to meet the 
definition of lead free in their assembled form, and that it is not the 
case that each individual component contained therein must meet lead 
free requirements. EPA revised the definition of ``nonpotable 
services'' (``all uses of water that are not potable uses'') to refer 
to ``all product uses and applications that are not potable uses'' 
because some nonpotable uses of the products do not involve the use of 
water. Based on public comment, the definition of ``pipe'' was expanded 
to include permanently attached end fittings, which EPA finds is a 
common product form. The definition of ``pipe fitting'' was amended to 
remove washers as one of several examples of those products. Washers 
may be components of plumbing fittings, or fixtures, but EPA does not 
consider individual washers to be pipe fittings. Manifolds were added 
to the definition of ``plumbing fitting'' because these products are 
becoming more commonplace as a means to control directional flow of 
potable water in homes and other buildings. In calculating the ``wetted 
surface area of the product,'' surfaces that are not exposed to liquid 
water, such as those surfaces in refrigerator ice dispensers, would not 
be ``wetted'' and, therefore, should not be considered in the 
calculation. In addition, because ice is either cubed or crushed, there 
is limited contact between the surface of the ice and the surface of 
the cubed or crushed ice as it sits in the bin or passes through the 
discharge chute. Including ice bins and ice discharge chutes in the 
calculation of the wetted surface area of combination ice and water 
dispensers would dilute the calculated wetted average lead content of 
the other components that are ``wetted'' and, therefore, are more 
likely to be a source of lead.
    In 40 CFR 143.11, a definition of ``custom fabricated product'' was 
added to this final rule to clarify the products for which self-
certification is an option for manufacturers and importers described in 
40 CFR 143.19, Required Certification of Products.
    In 40 CFR 143.11, the definition of ``importer'' was modified to 
mean any person who introduces into commerce any pipe, any pipe or 
plumbing fitting or fixture, or any solder or flux entering the United 
States; or any ``importer'' as defined in 19 CFR 101.1; or both. This 
change from the definition in proposed rulemaking was made to harmonize 
the definition of this final rule with that included in 19 CFR 101.1 by 
cross referencing it. That definition in Title 19 is as follows: 
``Importer'' means the person primarily liable for the payment of any 
duties on the merchandise, or an authorized agent acting on his behalf. 
The importer may be:
    (1) The consignee, or
    (2) The importer of record, or
    (3) The actual owner of the merchandise, if an actual owner's

[[Page 54247]]

declaration and superseding bond has been filed in accordance with 40 
CFR 141.20 of this chapter, or
    (4) The transferee of the merchandise, if the right to withdraw 
merchandise in a bonded warehouse has been transferred in accordance 
with subpart C of part 144 of this chapter.
2. Recordkeeping Provisions
a. Final Rule Requirements
    This 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. The manufacturer or importer must keep records for all 
products certified by an accredited third party certification body, 
which include, at a minimum, documentation of certification, of dates 
of certification, and of expiration. This documentation must be 
provided upon request to the Administrator as specified in 40 CFR 
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 this subpart. Sufficient 
documentation may include detailed schematic drawings of the products 
(indicating dimensions), records of calculations of the weighted 
average lead content of the product, documentation of the lead content 
of materials used in the manufacture of the product, 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 40 CFR 143.20(b) and must 
be maintained for at least five years after the last sale of the 
product by the manufacturer or importer.
b. Changes From Proposed Rule and Rationale
    The proposed rulemaking would have required manufacturers or 
importers of certified products to maintain documentation to 
substantiate product certification for an unspecified length of time. 
In this final rule, EPA is requiring manufacturers and importers to 
maintain such documentation for at least five years from the date of 
the last sale of the product by the manufacturer or importer (in 
response to comments requesting that EPA specify a time limit for 
document retention because it could otherwise be interpreted to be an 
on-going, continuous requirement). EPA contacted the eight ANSI 
accredited certification bodies prior to publication of the proposed 
rulemaking to obtain estimated cost for certifying products to ANSI/NSF 
Standard 372 and to obtain information on any time limits on the 
validity of the certification before renewal would be required by the 
certifying bodies. As EPA explained in the proposed rulemaking, while 
the period of time before the expiration of a certificate varies among 
certification bodies, the longest period of time is five years. (USEPA, 
2017; 82 FR 4817, January 17, 2017). Accordingly, EPA chose the minimum 
document retention time of five years from the date of last sale to be 
consistent with the maximum effective duration time for a third party 
product certification.
3. Compliance Provisions
a. Final Rule Requirements
    To effectively enforce the lead free requirements of the SDWA and 
the regulatory provisions, this final rule provides EPA with the 
ability to obtain, on a case-by-case basis, certain compliance-related 
information from manufacturers, importers, wholesalers, and retailers 
and others subject to SDWA section 1417, such as information related to 
the calculation of the weighted average of wetted surfaces, schematics 
of fittings/fixtures, and certification documentation. This final rule 
contains a provision in 40 CFR 143.20(b) providing the EPA 
Administrator with explicit authority to request such information on a 
case-by-case basis and a requirement for entities to provide the 
information requested to the Administrator. This provision is based on 
the statutory authority contained in section 1445(a)(1) of the SDWA. 
This final rule also includes a provision in 40 CFR 143.20(a) 
indicating that noncompliance with the SDWA or this subpart may be 
subject to enforcement. Enforcement actions may include seeking 
injunctive or declaratory relief and civil penalties or criminal 
penalties. This provision is based on authorities including section 
1414 of the SDWA and section 1001 of Title 18.
b. Changes From Proposed Rule and Rationale
    Clarification changes were made to the language in 40 CFR 143.20 of 
the proposed rulemaking to further specify that enforcement actions may 
also seek declaratory relief in addition to injunctive relief. These 
provisions will help EPA to effectively enforce the requirements of 
SDWA section 1417 and of this final rule.
4. State Enforcement of Use Prohibitions
a. Final Rule Requirements
    This final rule contains language in 40 CFR 143.14 to clarify that 
SDWA section 1417(b)'s direction for States to enforce the use 
prohibition on pipe, pipe fittings, or fixtures, any solder, or any 
flux that are not lead free is a condition of receiving a full Public 
Water System Supervision (PWSS) grant allocation. Under the SDWA, 
section 1417(b)(1), the State enforcement provision applies only to the 
use prohibition in section 1417(a)(1); it does not apply to the 
introduction into commerce prohibition in section 1417(a)(3) of the 
SDWA, nor does it apply to the final rule requirements for product 
certification.
b. Changes From Proposed Rule and Rationale
    No changes were made in 40 CFR 143.14 from the proposed rulemaking. 
The regulatory provision is based on the statutory direction in section 
1417(b) of the SDWA for States to enforce the statutory use prohibition 
through State or local plumbing codes or such other means as the State 
may determine to be appropriate. Similar regulatory language in current 
40 CFR 141.43 is being replaced by this final rule.
5. Removal of Lead Leaching Standard From Definition of Lead Free
a. Final Rule Requirements
    The final rule does not include a requirement for certification of 
plumbing fittings and fixtures to a lead leaching standard.
b. Changes From Proposed Rule and Rationale
    No changes were made to the proposed rulemaking. Many comments were 
received requesting that EPA require the lead leaching standard and 
associated certification requirements that were incorporated into the 
definition of lead free in section 1417(d) of the SDWA, prior to the 
amendment by the 2011 RLDWA. These comments were made in a mass public 
comment campaign submitted by 24,751 signatories as well as in some 
other individual comments, including two submitted by members of 
Congress. Some commenters suggested that EPA should require products to 
be certified to the NSF/ANSI 61 Standard to address lead leaching.
    The 2011 RLDWA revised section 1417 to redefine lead free in SDWA 
section 1417(d) to lower the maximum lead content from 8.0 percent to a 
weighted average of 0.25 percent of the wetted surfaces of plumbing 
products; established a statutory method for the

[[Page 54248]]

calculation of lead content; and eliminated the requirement that 
plumbing fittings and fixtures be in compliance with voluntary 
standards established in accordance with SDWA section 1417(e) for 
leaching of lead from new plumbing fittings and fixtures. While EPA 
supports the industry's voluntary use of a lead leaching standard and 
certification to that standard, a requirement for plumbing fittings and 
fixtures to be in compliance with it is not necessary or appropriate to 
implement section 1417 of the SDWA, because the requirement was 
specifically eliminated in the 2011 RLDWA.

F. Implementation Schedule

1. Final Rule Requirements
    The RLDWA, including the revised definition of lead free, has been 
in effect since January 4, 2014. See the DATES section of this document 
for effective and compliance dates for this final rule.
2. Changes From Proposed Rule and Rationale
    No change was made to the compliance date for the rule's 
certification requirement. The proposed compliance date for labeling 
requirements was removed because EPA is not finalizing those 
requirements.

V. Costs

    The primary cost estimate for this rule calculated according to the 
E.O. 13771 accounting standards--that is, as an annualized value over a 
perpetual time horizon, in 2016$, discounted to its 2016-equivalent 
using a 7% discount rate is $7.1 million. The quantitative cost 
estimates in the Final Rule Technical Support Document (USEPA, 2020) 
primarily focus on the discretionarily-imposed costs, and thus reflect 
a post-statute baseline. Because this rule codifies the RLDWA's 
statutory requirements, assessment relative to a pre-statute is also 
appropriate (and required by OMB Circular A-4). In analyses such as 
this one, in which impacts are assessed relative to multiple baselines, 
it is important to compare costs relative to the same baseline. EPA 
lacked data to conduct a quantitative pre-statutory baseline of costs 
but has included a qualitative discussion of the pre-statutory baseline 
in the Technical Support Document.
    Based on state and industry action prior to the RLDWA and economic 
theory, EPA's best estimate of the pre-statutory baseline (the world in 
the absence of the Federal RLDWA) is that states across the nation 
would have continued to implement their own lead-free standards, and 
industry would have made the decision to manufacture and market a 
single lead-free line of product meeting these state standards, if 
possible. There is also the possibility that these state standards 
might have varied leading to a patchwork of lead-free standards that 
would have been costly to comply with. Therefore, the most likely 
outcome of the self-implementing portions of the statute that created a 
single national standard, and in turn those components repeated in this 
rule, was a reduction in production costs due to increased conformity 
in lead free requirements.
    EPA collected data from public sources and private data vendors to 
develop the estimated rule costs to plumbing manufacturing firms. 
Annual production of potable use products is 1.3 billion units.
    There are 2,193 firms producing plumbing products impacted by this 
final rule, which are spread across 14 NAICS codes. Table V.1 
summarizes information for the segment of the industry that produces 
potable use products. Table V.1 also breaks down production into 
product subcategories and provides EPA's estimated annual production 
values for each subcategory, the NAICS code assigned to the 
subcategory, and the number of manufacturers in the subcategory.

 Table V.1--Product Subcategories, Production, NAICS and Number of Manufacturers EPA Identified for Potable Use
                                                    Products
----------------------------------------------------------------------------------------------------------------
                                                                  Units produced                     Number of
          Product category                   Product name            annually        NAICS for     manufacturers
                                                                      (2013)          product       for product
----------------------------------------------------------------------------------------------------------------
Pipe and Fittings..................  Copper Tube (<4'' in            233,049,645          332996             213
                                      diameter).
                                     PEX Pipe (<4'' in diameter)     348,583,587          326122              27
                                     CPVC Pipe (<4'' in              148,219,048          326122              48
                                      diameter).
                                     Copper Fittings (<4'' in         93,219,858          332913             119
                                      diameter).
                                     Brass Fittings (<4'' in          80,026,241          332913             523
                                      diameter).
                                     PEX Fittings (<4'' in            99,620,061          332913              47
                                      diameter).
                                     CPVC Pipe Fittings (<4'' in      59,287,619          332913              63
                                      diameter).
                                     Small and Mid-Diameter PVC       58,257,345          326122             143
                                      Pipe.
                                     PVC Pipe Fittings..........      14,927,862          332913             103
Faucets and Mixers.................  Kitchen and Bar Faucet            8,531,915          332913              74
                                      Market.
                                     Lavatory Faucet............      18,635,258          332913              74
Kitchen Sinks and Accessories......  Kitchen Sink...............       4,730,496          332999              24
                                     Sink Strainer..............      11,036,332          332999              24
Residential Water Filtration         Point-of-entry Residential        1,236,699          333318             713
 Products.                            Water Filtration Market.            72,857          333318             694
                                     Point-of-use Countertop
                                      Water Filtration Market.
                                     Point-of-use Under the Sink         261,702          333318             704
                                      Water Filtration Market.
                                     Point-of-use Faucet Mount         1,707,194          333318             694
                                      Water Filtration Market.
Stop Valves, Stainless Steel         Stop Valve Market..........       9,455,319          332911              23
 Braided Hoses, Inline Valves.       Stainless Steel Braided           9,424,559          333999             204
                                      Hose Market.                    30,597,771          332919             204
                                     Residential Inline Valve
                                      Market.
Water Heaters and Boilers..........  Combi Boiler Market........          55,527          333999              15
                                     Residential Gas Tankless            410,831          335228              20
                                      Water Heater Market.
                                     Residential Gas Storage           4,338,506          335228              11
                                      Water Heaters.
                                     Residential Electric              4,061,277          335228              11
                                      Storage Water Heaters.
                                     Residential Indirect Fired          133,647          335228              10
                                      Water Heater Market.
                                     Residential Electric                276,398          335228              19
                                      Tankless Water Heater
                                      Market.
                                     Residential Solar Storage            21,819          335228              42
                                      Water Heater Market.
                                     Residential Oil Water                31,692          335228               1
                                      Heaters.
                                     Commercial Gas Storage               89,706          335228              11
                                      Water Heater Market.

[[Page 54249]]

 
                                     Commercial Electric Storage          70,071          335228              15
                                      Water Heater Market.
Water Coolers/Drinking Fountains/    Water Cooler/Drinking               557,244          333415               5
 Bubblers.                            Fountain/Bubbler Market.
Household Appliances...............  Refrigerators with Water          4,540,527          335222               7
                                      Dispenser/Ice Making
                                      Machinery.
                                     Dishwasher Market..........       5,537,416          335228               5
                                     Water Softener Market......       3,444,782          333318              98
Household & Commercial Appliances..  Coffee Makers..............         234,247          333318              40
Other..............................  Aerator....................      27,167,173          332913               3
                                     Backflow preventers/Vacuum           32,202          332913              11
                                      Breakers.
                                     Gaskets/O-rings............       5,433,435          339991              13
                                     Pumps......................       1,808,369          333911              19
                                     Water Meters/End Point            7,053,100          334514              68
                                      Meters.
----------------------------------------------------------------------------------------------------------------
Source: Final Rule Technical Support Document, Exhibits 3-3 and 3-9 (USEPA, 2020).

    EPA developed cost estimates for the final rule along with three 
additional regulatory alternatives. The four alternatives that were 
considered are presented in Table V.2. Alternative C is the regulatory 
option selected for the final rule. The Final Rule Technical Support 
Document (USEPA, 2020) provides more detailed information on the 
costing methodology and a discussion of the uncertainties and 
limitations of this assessment.

     Table V.2--Comparison of Final Rule to Alternatives Considered
------------------------------------------------------------------------
   Alternatives considered                    Description
------------------------------------------------------------------------
A............................   Product marking and package
                                labeling for potable use products.
                                Third party certification
                                required for all firms.
B: Proposed Rule.............   Product marking and package
                                labeling for potable use products.
                                Self-certification or third
                                party certification for <100 Employees.
                                Third party certification only
                                for >=100 Employees.
C: FINAL RULE................   No required product marking, no
                                required package labeling for potable
                                use products.
                                Self-certification or third
                                party certification for <10 Employees
                                and for custom fabricated products.
                                Third party certification only
                                for >=10 Employees (unless custom
                                fabricated product).
D............................   Product marking or package
                                labeling for potable use products.
                                Third party certification or
                                self-certification for all firms.
------------------------------------------------------------------------

A. Initial Administrative and Initial Implementation Costs

    The analysis for initial administrative and implementation costs 
was conducted at the level of the manufacturing firm. For the final 
rule, EPA estimated that it would take each firm an average of 8 hours 
to read and understand the rule. This time estimate, when multiplied by 
an average labor rate of $71.72 and the number of firms affected by the 
rule (2,193), results in a total cost of $1.26 million, which was then 
annualized at 3 percent and 7 percent discount rates.
    Table V.3 provides the initial rule implementation annualized cost 
ranges by firm size category. The values were discounted at both the 3 
and 7 percent rates over the 25-year period of analysis. Annual total 
initial implementation costs range from $0.07 to $0.11 million.

 Table V.3--Final Rule Initial Administrative and Initial Implementation
                      Annualized Costs, in Millions
                                 [2014$]
------------------------------------------------------------------------
                                           Read and understand the rule
                                                 and initial rule
                                                  implementation
  Manufacturer size based on number of   -------------------------------
                employees                          Discount rate
                                         -------------------------------
                                                3%              7%
------------------------------------------------------------------------
<10.....................................          $0.027          $0.039
10-99...................................           0.023           0.033
100-499.................................           0.011           0.016
>=500...................................           0.008           0.012
All Sizes...............................           0.070           0.101
------------------------------------------------------------------------
Source: Final Rule Technical Support Document, Exhibit 4-5 (USEPA,
  2020).


[[Page 54250]]

B. Labeling Potable Use Products

    The final rule does not require any product marking or package 
labeling of potable use products to indicate lead free status; 
therefore, there is no cost for marking or labeling. EPA did consider 
alternative options that would have required product marking or package 
labeling or both. Table V.4 provides a summary of product labeling 
costs for this final rule with the other alternatives that were 
considered for comparative purposes for the various regulatory options 
that EPA considered. Since the final rule has no labeling costs, the 
methodology for estimating these costs for various alternatives is not 
provided in this document. However, it is included in the Technical 
Support Document for the Proposed Rule (USEPA, 2016) available in the 
docket for this rule.

 Table V.4--Total Annualized Present Value Costs for Lead Free Labeling
    of Potable Use Products on Product and Package for Final Rule and
                    Alternatives Considered, Millions
                                 [2014$]
------------------------------------------------------------------------
                                            3% Discount     7% Discount
                                              rate in         rate in
         Alternatives considered             millions        millions
                                              (2014$)         (2014$)
------------------------------------------------------------------------
A: Product and package messaging........     $8.69-10.34    $11.32-13.60
B: Product and package messaging........      8.69-10.34     11.32-13.60
C: FINAL RULE:
    No product messaging; No package                   0               0
     messaging..........................
D: Product or package messaging.........       1.17-1.28       1.14-1.26
------------------------------------------------------------------------
Source: Proposed Rule Technical Support Document, Exhibits 4-13a and 4-
  13b (USEPA, 2016).

C. Product Certification

    To develop total compliance costs for third party certification, 
EPA had to determine the regulatory baseline. This baseline represents 
the current industry practice with regard to third party certification. 
EPA compiled information on plumbing manufacturers' use of third party 
certification by reviewing current State laws requiring certification 
for NSF Standards 61 and 372; reviewing the International and Uniform 
Plumbing Codes; contacting the two primary industry trade groups, PMI 
and AFS; and acquiring information from industry third party 
certifiers. Based on the collected information, EPA assumed that 90 
percent of manufacturers with 100 or more employees already use an 
accredited third party agency to certify that their products are lead 
free. As with potable use product labeling, third party certification 
costs are a major driver of overall cost to manufacturers; therefore, 
EPA developed lower and upper bound cost scenarios based on baseline 
compliance assumptions for firms having less than 100 employees. Fifty 
to 75 percent of plumbing manufacturers having fewer than 100 employees 
are assumed to use third party certification bodies. Table V.5 
summarizes the third party certification baseline assumptions EPA used 
in the development of regulatory costs. Under all regulatory 
alternatives considered, certification costs would be attributable to 
only those manufacturers that do not already use these third party 
certification bodies.

Table V.5--Estimated Percentage of Manufacturers That Do Not Already Use
                    Third Party Certification Bodies
------------------------------------------------------------------------
                                            Percentage of manufacturers
                                             that currently do not use
                                           third party certifying bodies
                                            and to which certification
 Manufacturer size (number of employees)         costs would apply
                                         -------------------------------
                                            Lower bound     Upper bound
                                                (%)             (%)
------------------------------------------------------------------------
<10.....................................              25              50
10-99...................................              25              50
100-499.................................              10              10
>=500...................................              10              10
------------------------------------------------------------------------
Source: Final Rule Technical Support Document, Exhibit 4-6 (USEPA,
  2020).

    Third party certifying firms usually conduct the certification 
process according to product families. For NSF/ANSI Standard 372, 
products of the same material formulation and similar configuration are 
considered one product family. Thus, certifying costs were developed on 
a product family basis. EPA estimated that each firm produces an 
average of three product families based on an assessment of firm 
website data for manufacturers across all potable use product 
subcategories.
    Certification costs can be broken down into initial assessment and 
testing costs and annual renewal costs. Most of the accredited, third 
party certification bodies offer an annual renewal based on an audit 
process for a set number of years after the initial certification year. 
To derive initial and renewal certification unit costs, EPA contacted 
the eight ANSI accredited, third party certification bodies to obtain 
estimated costs for certifying products to ANSI/NSF Standard 372. The 
certification bodies were asked to provide estimates for four 
representative product categories (faucets, fittings, valves, and 
pipes), which are intended to represent the range in complexity of 
plumbing products.
    Four certification bodies provided quotes of sufficient specificity 
or comparable scope to be used in

[[Page 54251]]

estimating initial certification costs. Costs varied based on the 
product type and certifying body. EPA used the average of these quotes 
across firms and product types to derive a composite estimated cost of 
$6,000 for an initial certification of a single product family. Five of 
the eight certification bodies provided estimates for annually renewing 
the third party certification to NSF/ANSI Standard 372. Costs varied 
based on the product type and certification body. One of the responding 
certification bodies required re-certification annually. The other four 
certification bodies require renewal on a less frequent basis, the 
longest being every five years. EPA determined a 5-year cost stream for 
each of the third party certifiers and computed a per product family 
average annual renewal cost of $3,200. In addition to the certifiers' 
fees, EPA assumed a $224 annualized cost for recordkeeping on the part 
of the plumbing manufacturing firms.
    The final rule and Alternatives B and D allow for some firms to 
self-certify to comply with the lead free requirements. EPA estimated 
that each manufacturer would require 40 hours of labor to initially 
develop the certificate of conformity (the rule requirement for the 
certificate of conformity can be found in section IV.D of this 
preamble), which certifies a product family as being compliant with the 
lead free requirements. The unit cost per product family is $1,122. The 
labor burden for the annual renewal of the self-certification per 
product family is estimated to be 16 hours. This time is used to update 
the certificate of conformity and to perform recordkeeping activities. 
This means that the unit cost of annual self-recertification is $449 
per product family for the final rule, as well as for Alternatives A 
and D.
    Table V.6 provides EPA's estimated total annual cost ranges for 
potable use product certification requirements of the final rule and 
other alternatives that were considered. Unit certification costs were 
multiplied by the number of firms and average number of product 
families. The final rule requires third party certification for firms 
with 10 or more employees and gives the option of self-certification to 
firms with fewer than 10 employees. Annualized certification cost for 
the final rule ranges from $6.67 million to $12.24 million. EPA did not 
assess any cost savings to firms that would no longer choose to have 
products third party certified because EPA assumed that firms that were 
already having their products third party certified would continue 
doing so after rule implementation.

  Table V.6--Total Annualized Present Value Costs for Demonstration of
   Compliance Requirements for Final Rule and Alternatives Considered,
                                Millions
                                 [2014$]
------------------------------------------------------------------------
                                            3% Discount     7% Discount
                                              rate in         rate in
         Alternatives considered             millions        millions
                                              (2014$)         (2014$)
------------------------------------------------------------------------
A: Third party certification only.......   $11.20-$20.90   $11.56-$21.58
B: Proposed Rule Third party for >=100;        2.82-4.14       2.93-4.31
 Choice of self-certification for <100..
C: FINAL RULE Third party for >=10;           6.66-11.82      6.89-12.23
 Choice of self-certification for <10
 and for custom fabricated products.....
D: Third party certification or self-          1.52-2.84       1.59-2.98
 certification..........................
------------------------------------------------------------------------
Source: Final Rule Technical Support Document, Exhibits 4-12a and 4-12b
  (USEPA, 2020).
Note: Under Alternatives B, C, and D, all manufacturers eligible for
  self-certification are assumed to select the less costly choice of
  self-certification.

D. Response to EPA Data Request Costs

    Under all four of the final regulatory alternatives that were 
considered, manufacturers will be required to respond to EPA's requests 
for product information (see section IV.E.2 of this preamble for a 
detailed description of the data request provision). EPA assumed that 
firms would spend an average of 20 hours responding to each data 
request, resulting in a unit cost of approximately $1,400. As part of 
the cost assessment, EPA multiplied the per unit cost by 10 unique data 
requests per year, starting in the fourth year after promulgation of 
the final rule and continuing over the 25-year period of analysis. 
Seventy percent of requests would be to firms with 500 or more 
employees, 20 percent of requests would be to firms with 100 to 499 
employees, 5 percent of requests would be to firms with 10 to 99 
employees, and firms with fewer than 10 employees would receive the 
remaining 5 percent. This breakdown of requests between firm size 
categories roughly corresponds to the proportion of total products 
produced by firms in each of the size categories. Table V.7 shows the 
total annualized costs of EPA data request responses by firm size 
category. Total data request costs range from approximately $12,400 a 
year discounted at 3 percent to about $11,900 a year when discounted at 
7 percent.

 Table V.7--Total Annualized Present Value Costs for Responding to Data
                          Requests, in Millions
                                 [2014$]
------------------------------------------------------------------------
  Manufacturer size based on number of      3% Discount     7% Discount
                employees                      rate            rate
------------------------------------------------------------------------
<99.....................................         $0.0006         $0.0006
100-499.................................          0.0025          0.0024
>=500...................................          0.0087          0.0083
All Sizes...............................          0.0124          0.0119
------------------------------------------------------------------------
Source: Final Rule Technical Support Document, Exhibit 4-14 (USEPA,
  2020).


[[Page 54252]]

VI. Economic Impact Analysis

    EPA assessed the social costs and the projected economic impacts of 
the final rule and the other regulatory alternatives that were 
considered. This section provides an overview of the methodology that 
EPA used to assess the social costs and the economic impacts of the 
final rule and summarizes the results of these analyses. The Final Rule 
Technical Support Document (USEPA, 2020), which is available in the 
docket, provides more details on these analyses, including discussions 
of uncertainties and limitations.

A. Annualized Social Costs Estimates

    EPA estimated the total annualized social costs to plumbing 
manufacturers by summing the final rule and regulatory alternatives' 
component costs, which include administrative requirement costs, the 
cost to potable use product manufacturers for both labeling on the 
product and on the product's packaging, third party and self-
certification costs, and the costs of responding to EPA data requests. 
EPA annualized the stream of future costs using both the 3 percent (the 
social discount rate) and 7 percent (opportunity cost of capital) 
discount rates. EPA annualized one-time costs over the period of 
analysis, 25 years. Capital and O&M costs recurring not on an annual 
basis were annualized over a specific useful life, implementation, and/
or event recurrence period (e.g., 10 years for mold modifications), 
using discount rates of 3 and 7 percent. EPA added up the annualized 
capital, initial one-time costs, and the annual and non-annual portion 
of O&M costs to derive total annualized compliance costs, where all 
costs are expressed on an equivalent constantly recurring annual cost 
basis.
    Table VI.1 presents the total annualized compliance costs of the 
final rule and regulatory alternatives that were considered. As shown 
in the table, total annualized compliance costs for the final rule are 
estimated to range between $7 million to $12 million. Estimated 
annualized costs for other alternatives considered ranged from $3 
million and $36 million for Alternatives D and A, respectively.

      Table VI.1--Total Annualized Social Costs for Final Rule and
                         Alternatives Considered
                            [Millions, 2014$]
------------------------------------------------------------------------
                                            3% Discount     7% Discount
        Alternatives considered 1              rate            rate
------------------------------------------------------------------------
A: Label product and packaging; third        $20.1-$31.6     $23.1-$35.5
 party certification for all
 manufacturers..........................
B: Proposed Rule: Label product and            11.8-14.8       14.5-18.3
 packaging; third party certification
 for manufacturers >=100 employees and
 third party or self-certification for
 those <100.............................
C: FINAL RULE: No labeling product or           6.7-11.9        7.0-12.3
 package; third party certification for
 manufacturers >=10 employees and third
 party or self-certification for those
 <10 and for custom fabricated products.
D: Label product or packaging; third             2.9-4.5         3.0-4.6
 party or self-certification for all
 manufacturers..........................
------------------------------------------------------------------------
Source: Final Rule Technical Support Document, Exhibit 4-16 (USEPA,
  2020).
1 Table includes annualized costs for rule implementation, certification
  of potable use products, and EPA requests for data. Lead-related
  messaging for potable use products and products eligible for the
  ``used exclusively'' exemption that was in the proposed rule is
  included in Alternatives A, B, and D only, but not applicable for the
  final rule C.

B. Economic Impacts--Cost-to-Revenue Analysis

    To provide an assessment of the impact of the rule on manufacturing 
firms, EPA used a cost-to-revenue analysis. The cost-to-revenue 
analysis compares the total annualized compliance cost of each 
regulatory alternative considered with the revenue of the impacted 
entities. This same analysis is also used under the Regulatory 
Flexibility Act (RFA) to determine whether a rule has the potential to 
have a significant impact on a substantial number of small entities.
    To conduct the cost-to-revenue test, EPA developed a list of 2,193 
manufacturers that participate in the production of specific types of 
products that are principally used for potable use and those that might 
not be used exclusively for nonpotable services. These firms were 
assigned to a NAICS code based on the type of product they manufacture. 
Firm size distributional information, based on number of employees, 
available from the U.S. Census Bureau's Statistics of U.S. Businesses 
for the year 2012 was then used to parse the number of entities in each 
NAICS code into a number of small business and large firm categories. 
In this way, EPA derived the number of firms in each of the 14 NAICS 
codes broken down by the seven employee size categories each (i.e., 0-
4, 5-9, 10-19, 20-99, 100-499, 500+ to the Small Business 
Administration (SBA) small business threshold, and large firms above 
the SBA threshold). Computation of total average firm cost under each 
of the NAICS/employee entity size categories was developed by applying 
the estimated unit fixed and variable costs to each regulatory 
alternative considered. To calculate total average variable costs for 
each size category, unit variable costs must be adjusted by the units 
produced and firms producing in each of the NAICS/employee size 
categories. To determine the number of units produced per NAICS/
employee size category, EPA used information from the U.S. Census 
Bureau's Statistics of U.S. Businesses. The Census Bureau does not 
provide units produced for each of the NAICS employee size categories, 
so EPA used the percent of firm receipts by size category as a proxy. 
The approximated units per size category were then divided by the 
estimated number of entities in the category (derivation of the number 
of entities per NAICS/employee size category was previously described) 
giving average units produced per firm. Average units per firm for each 
size category was multiplied by unit variable cost to get total 
variable cost for each NAICS/employees size category. The Census does 
not provide revenue values by NAICS and employee sizes; consequently, 
EPA used data on total annual receipts (assuming receipts is an 
unbiased estimator) by NAICS/employee size categories as a close 
(although more conservative) approximation of revenue. The total 
receipts information was divided by the number of firms per category to 
approximate average revenue.
    EPA then compared the computed average annual costs with the 
average revenue for each of the NAICS/employee size categories. If 
average cost exceeded revenue by 1 percent, all firms assigned to that 
category were assumed to incur impacts. Likewise, if average annual 
cost exceeded revenue by 3 percent in a NAICS/employee size category, 
all entities in that category

[[Page 54253]]

were assumed to be impacted at the 3 percent level. Impacted firms were 
summed across NAICS codes and employee size categories to assess the 
total impact to the industry.
    Table VI.2 summarizes the cost-to-revenue analysis results for the 
final rule as compared with the three other regulatory alternatives 
that were considered. The table shows only the largest impact scenarios 
analyzed, based on upper bound compliance cost estimates and a 7 
percent discount rate. For the lower bound cost and 3 percent 
discounted impact results, see the Final Rule Technical Support 
Document (USEPA, 2020). For the final rule (which includes rule 
implementation costs, third party certification costs for firms with 10 
or more employees and third party or self-certification costs for firms 
with fewer than 10 employees, and data request costs), EPA estimates 
that all plumbing manufacturing firms subject to the regulations will 
incur annualized costs amounting to less than 1 percent of revenue. No 
small manufacturers had impacts between 1 and 3 percent of revenue. The 
analysis of the final rule also found that no large entity had impacts 
between 1 and 3 percent of revenue.

                       Table VI.2--Summary of Cost-to-Revenue Economic Impact Analysis for Final Rule and Alternatives Considered
                                [Upper bound scenario, small entities 7% discount rate, large entities 3% discount rate]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Small entities (7% discount rate)            Large entities (3% discount rate)
                                                               -----------------------------------------------------------------------------------------
       Alternatives considered              Description 1                Count 2              Percentage              Count 2              Percentage
                                                               -----------------------------------------------------------------------------------------
                                                                 Total     >=1%     >=3%     >=1%     >=3%    Total     >=1%     >=3%     >=1%     >=3%
--------------------------------------------------------------------------------------------------------------------------------------------------------
A....................................  Product and Package        1,976      783       27       40        1      217        0        0      0.0      0.0
                                        Costs for Potable,
                                        Product or Package
                                        Costs for ``Used
                                        Exclusively'' Exempt
                                        Product, 3rd Party
                                        Cert for all
                                        manufacturers.
Proposed Rule B......................  Product and Package        1,976       29        0        2        0      217        0        0      0.0      0.0
                                        Costs for Potable,
                                        Product or Package
                                        Costs for ``Used
                                        Exclusively'' Exempt
                                        Product, 3rd Party
                                        Cert for >=100
                                        employees, Self or 3rd
                                        Party Cert for <100
                                        employees.
FINAL RULE C.........................  No Product or Package      1,976        0        0      0.0      0.0      217        0        0      0.0      0.0
                                        Costs, 3rd Party Cert
                                        for >=10 employees,
                                        Self or 3rd Party Cert
                                        <10 employees and
                                        custom fabricated
                                        products.
D....................................  Product or Package         1,976        0        0      0.0      0.0      217        0        0      0.0      0.0
                                        Costs for Potable,
                                        Product or Package
                                        Costs for ``Used
                                        Exclusively'' Exempt
                                        Product, Self or 3rd
                                        Party Cert for all
                                        manufacturers.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Final Rule Technical Support Document, Exhibit 6-7 (USEPA, 2020).
1 All alternatives considered also include implementation and data request costs. For Alternatives B and C, EPA assumes that manufacturers <100
  employees or <10 employees, respectively, choose the least-cost option of self-certification. For Alternative D, EPA assumes all manufacturers pick
  the least cost option of self-certification. In addition, for Alternative D, EPA assumes manufacturers choose the least cost option for labeling,
  which is usually package labeling except when the products do not have packaging.
2 Counts of impacted entities are rounded up to 1 if they fall between 0 and 1.

VII. Benefits

    EPA did not quantify the expected reduction in adverse health 
effects associated with the final regulation nor with the enactment of 
the RLDWA. The adoption of lead free plumbing materials likely occurred 
as a result of plumbing manufacturing industry response to requirements 
enacted in some states as early as 2006 (see the Final Rule Technical 
Support Document for more discussion). The changes made by plumbing 
manufacturers to reduce lead content of plumbing materials likely 
resulted in much greater lead exposure reductions than this regulation. 
EPA believes that there will be benefits of the final regulations from

[[Page 54254]]

the improved implementation of the requirements of the RLDWA and 
greater consistency in assuring that plumbing products are lead free, 
which will minimize the likelihood that non-lead free products would be 
sold or used for potable use applications. This improved implementation 
and consistency in conformity may result in some reductions to drinking 
water lead ingestion, however EPA cannot estimate the magnitude of 
those reductions. EPA qualitatively assessed the health effects 
associated with reductions in lead ingestion using two main sources: 
(1) The EPA ``Integrated Science Assessment for Lead'' (USEPA, 2013b); 
and (2) the National Toxicity Program's Monograph on Health Effects of 
Low-level Lead (USHHS, 2012). These two sources have both documented 
the association between lead and adverse cardiovascular effects, renal 
effects, reproductive effects, immunological effects, neurological 
effects, and cancer. EPA's Integrated Risk Information System (IRIS) 
Chemical Assessment Summary provides additional health effects 
information on lead (USEPA, 2004). For a more detailed explanation of 
the health effects associated with lead for children and adults see 
Chapter 5 and Appendix C of the Technical Support Document for the 
Final Rule (USEPA, 2020).

VIII. Statutory and Executive Orders Review

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is a significant regulatory action that was submitted 
to the Office of Management and Budget (OMB) for review because it 
raises novel legal or policy issues. Any changes made in response to 
OMB recommendations have been documented in the docket. The EPA 
prepared an economic analysis of the potential costs and benefits 
associated with this action. The economic analysis is included in the 
``Technical Support Document for the Final Rule: Use of Lead Free 
Pipes, Fittings, Fixtures, Solder, and Flux for Drinking Water,'' which 
is available in Docket ID No. EPA-HQ-OW-2015-0680, and is briefly 
summarized in section V of this preamble.

B. Executive Order 13771: Reducing Regulations and Controlling 
Regulatory Costs

    This action is considered an Executive Order 13771 regulatory 
action. Details on the estimated costs of this final rule can be found 
in EPA's analysis of the potential costs and benefits associated with 
this action in sections V through VII of this preamble and in the 
Technical Support Document for the Final Rule.

C. Paperwork Reduction Act (PRA)

    The information collection activities in this final rule have been 
submitted for approval to the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act (PRA). The Information Collection 
Request (ICR) document that EPA prepared has been assigned EPA ICR 
number. 2040-NEW. You can find a copy of the ICR in the docket for this 
rule, and it is briefly summarized in this section. The information 
collection requirements are not enforceable until OMB approves them.
    The PRA requires EPA to estimate the burden on manufacturers 
complying with the final rule. For the first three years after 
publication of the final rule in the Federal Register, manufacturers 
will incur burdens to conduct the following rule compliance activities:
     Reading and understanding the rule requirements.
     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 record costs 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.
    Respondents/affected entities: The respondents include 
manufacturers and importers entering products purchased from or 
manufactured by manufacturers of plumbing products for potable use.
    Respondent's obligation to respond: Mandatory (Safe Drinking Water 
Act Section, 42 U.S.C. 300f et seq.)
    Estimated number of respondents: 2,193 firms.
    Frequency of response: Once for obtaining initial third party or 
self-certification activities to indicate that a product meets the lead 
free requirements and occasionally, as needed, for EPA requests for 
information.
    Total estimated burden: Estimates for average annual burden ranges 
from 42,990 to 77,838 hours (per year). Burden is defined at 5 CFR 
1320.3(b).
    Total estimated cost: Estimates for average annual costs range from 
$6.69 million to $11.58 million (per year) and include $5.23 to $9.14 
million in annualized capital or operation and maintenance.
    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. When OMB approves 
this ICR, EPA will announce the approval in the Federal Register and 
publish a technical amendment to 40 CFR part 9 to display the OMB 
control number for the approved information collection activities in 
this final rule.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA. The 
small entities subject to the requirements of this action are the 
manufacturing firms involved in the production of pipe, pipe or 
plumbing fitting or fixture, flux or solder, which are utilized in 
public water systems, or any plumbing in a residential or 
nonresidential facility or location that provides water for human 
consumption, and that meet the SBA's size standards for small 
businesses. Firms providing these types of plumbing products span 
fourteen different North American Industrial Classification System 
(NAICS) categories. The SBA small business definitions used in the 
analysis of this final rule vary across NAICS categories and range from 
firms with fewer than 500 employees to firms with fewer than 1,250 
employees (See Table VIII.1).

       Table VIII.1--SBA Small Entity Size Standards by NAICS Code
------------------------------------------------------------------------
                                                             SBA size
                       NAICS code                            standard
------------------------------------------------------------------------
326122..................................................             750
332911..................................................             750
332913..................................................            1000
332919..................................................             750
332996..................................................             500
332999..................................................             750
333318..................................................            1000
333415..................................................            1250
333911..................................................             750
333999..................................................             500
334514..................................................             750
335222..................................................            1250
335228..................................................            1000
339991..................................................             500
------------------------------------------------------------------------

    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

[[Page 54255]]

entities is described in detail in section VI.B (Economic Impacts) of 
this preamble. 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.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. The final rule 
places no federal mandates on State, local, or Tribal governments. The 
mandated annual cost to the private sector is estimated to be between 
$6.7 and $12.3 million and the highest single year nominal cost is 
$15.4 million, which is below the $100 million UMRA threshold.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have Tribal implications as specified in 
Executive Order 13175. It would not have substantial direct effects on 
Tribal governments, on the relationship between the federal government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the federal government and Indian Tribes. This final rule 
contains no federal mandates for Tribal governments and does not impose 
any enforceable duties on Tribal governments. Thus, Executive Order 
13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental 
Health & Safety Risks

    EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that concern environmental health or safety risks 
that EPA has reason to believe may be disproportionately affect 
children, per the definition of ``covered regulatory action'' in 
section 2-202 of the Executive Order. This action is not subject to 
Executive Order 13045 because it implements specific standards 
established by Congress in statute. While Executive Order 13045 does 
not apply, EPA does anticipate that the product certification 
requirements associated with this final rule will limit the use of 
leaded plumbing products, thereby reducing the exposure of children to 
lead in drinking water.

I. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This action is not a ``significant energy action'' because it is 
not likely to have a significant adverse effect on the supply, 
distribution, or use of energy. This rule implements statutory 
requirements for lead content limits of pipes, fittings, and fixtures 
for installation or repair of public water systems and plumbing that 
supplies potable water and provides for verification of lead content. 
The lead content of these manufactured materials would not have a 
significant impact on the supply, distribution, or use of energy

J. National Technology Transfer and Advancement Act (NTTAA)

    This action involves technical standards. EPA is establishing a 
requirement that can be satisfied, depending on the size of the 
regulated entity or whether products are custom fabricated or not, 
either by self-certifying compliance with the SDWA lead prohibition or 
by achieving a voluntary standard that mirrors the SDWA requirements, 
such as the NSF/ANSI 372 standard. While EPA is not specifying a 
technical standard under this final rule, EPA is establishing the use 
of several technical standards that meet the new definition of lead 
free as a means of demonstrating compliance with this rule.

K. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    EPA has determined that this action does not have 
disproportionately high and adverse human health or environmental 
effects on minority populations, low-income populations, or indigenous 
peoples as described in Executive Order 12898 (59 FR 7629, February 16, 
1994), because this action does not establish any specific regulatory 
requirements that would affect these communities. Instead, it is a 
final rule that codifies existing requirements set forth by Congress 
regarding the allowable levels of lead in plumbing products, and 
includes additional provisions intended to aid in the implementation of 
those requirements.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and EPA will submit a rule 
report to each House of Congress and to the Comptroller General of the 
United States. This action is not a ``major rule'' as defined in 5 
U.S.C. 804(2). 2018.

IX. References

2018 International Plumbing Code, 2017. International Code Council, 
Inc. Chapter 6. August 2017. Available for viewing on the internet 
at: https://codes.iccsafe.org/content/IPC2018/chapter-6-water-supply-and-distribution
CalEPA (California Environmental Protection Agency). 2013. 2011 
Report of Lead in Plumbing Sampling. Second Annual Report. February 
2013. Available on the internet at: https://dtsc.ca.gov/wp-content/uploads/sites/31/2017/05/LIP-FEB2013.pdf
National Toxicity Program, 2012. Monograph on Health Effects of Low-
level Lead. U.S. Department of Health and Human Services. June 2012. 
Available on the internet at: https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf
USEPA, 2004. Integrated Risk Information System (IRIS) Chemical 
Assessment Summary for Lead and Compounds (inorganic); CASRN 7439-
92-1. 2004. Available on the internet at https://cfpub.epa.gov/ncea/iris/iris_documents/documents/subst/0277_summary.pdf
USEPA, 2013a. Summary of the Reduction of Lead in Drinking Water Act 
and Frequently Asked Questions. December 2013. Available on the 
internet at regulations.gov: https://www.regulations.gov/document?D=EPA-HQ-OW-2015-0680-0250
USEPA, 2013b. Final Report: Integrated Science Assessment for Lead. 
EPA 600-R-10-075F. June 2013. Available on the internet at: https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=255721
USEPA, 2016. Technical Support Document for the Proposed Rule: Use 
of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking 
Water. EPA 815-R-16-009. December 2016.
USEPA, 2017. Use of Lead Free Pipes, Fittings, Fixtures, Solder and 
Flux for Drinking Water--Proposed Rule. Federal Register. Vol. 82, 
No. 10. P. 4805. January 17, 2017.
USEPA, 2020. Technical Support Document for the Final Rule: Use of 
Lead Free Pipes, Fittings, Fixtures, Solder, and Flux for Drinking 
Water. EPA 810-R-20-001. June 2020.

List of Subjects

40 CFR Part 141

    Environmental protection, Chemicals, Indian--lands, 
Intergovernmental

[[Page 54256]]

relations, Radiation protection, Reporting and recordkeeping 
requirements, Water supply.

40 CFR Part 143

    Environmental protection, Chemicals, Indian--lands, Water supply.

Andrew Wheeler,
Administrator.

    For the reasons set forth in the preamble, the EPA amends 40 CFR 
parts 141 and 143 as follows:

PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS

0
1. The authority citation for part 141 continues to read as follows:

    Authority:  42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 
300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.


0
2. Revise the heading for Subpart E to read as follows:

Subpart E--Special Regulations, Including Monitoring


Sec.  141.43   [Removed]

0
3. Remove Sec.  141.43.

PART 143--OTHER SAFE DRINKING WATER ACT REGULATIONS

0
4. The authority citation for part 143 continues to read as follows:

    Authority:  42 U.S.C. 300f et seq.

0
5. Revise the heading for part 143 as set forth above.


Sec. Sec.  143.1 through 143.4   [Designated as subpart A]

0
6. Designate Sec. Sec.  143.1 through 143.4 as subpart A, and add a 
heading for newly designated subpart A to read as follows:

Subpart A--National Secondary Drinking Water Regulations


Sec.  143.1   [Amended]

0
7. Amend Sec.  143.1 by removing the text ``part'', and adding in its 
place ``subpart'', by removing the text ``These regulations'', and 
adding its place ``The regulations in this subpart'', and removing 
``The regulations'' and adding its place ``The regulations in this 
subpart''.


Sec. Sec.  143.5 through 143.9   [Added and Reserved]

0
9. Add and reserve Sec. Sec.  143.5 through 143.9.

0
10. Add subpart B, consisting of Sec. Sec.  143.10 through 143.20, to 
read as follows:
Subpart B--Use of Lead Free Pipes, Fittings, Fixtures, Solder, and Flux 
for Drinking Water
Sec.
143.10 Applicability and Scope.
143.11 Definitions.
143.12 Definition of lead free and calculation methodology.
143.13 Use prohibitions.
143.14 State enforcement of use prohibitions.
143.15 Introduction into commerce prohibitions.
143.16 Exemptions.
143.17 Reserved.
143.18 Required labeling of solder and flux that is not lead free.
143.19 Required certification of products.
143.20 Compliance provisions.

Subpart B--Use of Lead Free Pipes, Fittings, Fixtures, Solder, and 
Flux for Drinking Water


Sec.  143.10   Applicability and Scope.

    (a) This subpart establishes regulations pertaining to pipes, pipe 
or plumbing fittings, or fixtures, solder and flux, pursuant to, inter 
alia, sections 1417 and 1461 of the Safe Drinking Water Act (42 U.S.C. 
300g-6 and 300j-21). It applies to any person who introduces these 
products into commerce, such as manufacturers, importers, wholesalers, 
distributors, re-sellers, and retailers. It also applies to any person 
who uses these products in the installation or repair of:
    (1) A public water system; or
    (2) A residential or nonresidential facility providing water for 
human consumption.
    (b) Reserved.


Sec.  143.11   Definitions.

    The following definitions apply to this subpart:
    Accredited third party certification body means those bodies that 
are accredited by the American National Standards Institute (ANSI) to 
provide product certification to meet the lead free requirements of not 
more than a weighted average of 0.25 percent lead content when used 
with respect to the wetted surfaces, consistent with section 1417 of 
the Safe Drinking Water Act and Sec.  143.12, such as certification to 
the NSF/ANSI 372 standard.
    Administrator means the Administrator of the U.S. Environmental 
Protection Agency or his or her authorized representative.
    Affiliated means a person or entity that directly or indirectly 
through one or more intermediaries, controls or is controlled by, or is 
under common control with, the person or entity specified. Affiliated 
persons or entities include but are not limited to: A parent company 
and all wholly or partially owned subsidiaries of a parent company, or 
two or more corporations or family partnerships that have overlap in 
ownership or control.
    Alloy means a substance composed of two or more metals or of a 
metal and a nonmetal.
    Coating means a thin layer of material such as paint, epoxy, zinc 
galvanization, or other material usually applied by spraying or in 
liquid form to coat internal surfaces of pipes, fittings, or fixtures.
    Custom fabricated product means a product that:
    (1) Is manufactured on a case-by-case basis to accommodate the 
unique needs of a single customer;
    (2) Does not have a Universal Product Code (UPC) assigned to the 
product;
    (3) Is not stocked by and is not available through inventory from a 
manufacturer, importer, wholesaler, distributor, retailer, or other 
source for distribution; and
    (4) Is not cataloged in print or on the internet with a specific 
item number or code.
    Drinking water cooler means any mechanical device, affixed to 
drinking water supply plumbing, which actively cools water for human 
consumption.
    Fitting means a pipe fitting or plumbing fitting.
    Fixture means a receptacle or device that is connected to a water 
supply system or discharges to a drainage system or both. Fixtures used 
for potable uses shall include but are not limited to:
    (1) Drinking water coolers, drinking water fountains, drinking 
water bottle fillers, dishwashers;
    (2) Plumbed in devices, such as point-of-use treatment devices, 
coffee makers, and refrigerator ice and water dispensers; and
    (3) Water heaters, water meters, water pumps, and water tanks, 
unless such fixtures are not used for potable uses.
    Flux means a substance used for helping to melt or join metals such 
as by removal of oxides and other coatings or residues from the metals 
before joining by using solder or other means.
    Importer means any person who introduces into commerce any pipe, 
any pipe or plumbing fitting or fixture, or any solder or flux entering 
the United States; or any ``importer'' as defined in 19 CFR 101.1; or 
both.
    Introduce into commerce or introduction into commerce means the 
sale or distribution of products or offering products for sale or 
distribution in the United States.
    Liner means a rigid lining such as a plastic or copper sleeve that 
is:

[[Page 54257]]

    (1) Sealed with a permanent barrier to exclude lead-bearing 
surfaces from water contact; and
    (2) Of sufficient thickness and otherwise having physical 
properties necessary to prevent erosion and cracking for the expected 
useful life of the product.
    Manufacturer means a person or entity who:
    (1) Processes or makes a product; or
    (2) Has products processed or made under a contractual arrangement 
for distribution, using the person's or entity's brand name or 
trademark.
    Nonpotable services means all product uses and applications that 
are not potable uses.
    Person means an individual; corporation; company; association; 
partnership; municipality; or State, federal, or Tribal agency 
(including officers, employees, and agents of any corporation, company, 
association, municipality, State, Tribal, or federal agency).
    Pipe means a conduit, conductor, tubing, or hose and may also 
include permanently attached end fittings.
    Pipe fitting means any piece (such as a coupling, elbow, or gasket) 
used for connecting pipe lengths together or to connect other plumbing 
pieces together or to change direction.
    Plumbing fitting means a plumbing component that controls the 
volume and/or directional flow of water, such as kitchen faucets, 
bathroom lavatory faucets, manifolds, and valves.
    Point-of-use treatment device means point-of-use treatment device 
as defined in Sec.  141.2 of this chapter.
    Potable uses, for purposes only of this subpart, means services or 
applications that provide water for human ingestion, such as for 
drinking, cooking, food preparation, dishwashing, teeth brushing, or 
maintaining oral hygiene.
    Product means a pipe, fitting, or fixture.
    Public water system means a public water system as defined in Sec.  
141.2 of this chapter.
    Solder means a type of metal that is used to join metal parts such 
as sections of pipe, without melting the existing metal in the parts to 
be joined. Solder is usually sold or distributed in the form of wire 
rolls or bars.
    State means state as defined in Sec.  142.2 of this chapter.
    United States includes its commonwealths, districts, States, 
Tribes, and Territories.
    Water distribution main means a pipe, typically found under or 
adjacent to a roadway, that supplies water to buildings via service 
lines.


Sec.  143.12   Definition of lead free and calculation methodology.

    (a) ``Lead free'' for the purposes of this subpart means:
    (1) Not containing more than 0.2 percent lead when used with 
respect to solder and flux; and
    (2) Not more than a weighted average of 0.25 percent lead when used 
with respect to the wetted surfaces of pipes, pipe fittings, plumbing 
fittings, and fixtures.
    (b) The weighted average lead content of a pipe, pipe fitting, 
plumbing fitting, or fixture is calculated by using the following 
formula: For each wetted component, the percentage of lead in the 
component is multiplied by the ratio of the wetted surface area of that 
component to the total wetted surface area of the entire product to 
arrive at the weighted percentage of lead of the component. The 
weighted percentage of lead of each wetted component is added together, 
and the sum of these weighted percentages constitutes the weighted 
average lead content of the product. The lead content of the material 
used to produce wetted components is used to determine compliance with 
paragraph (a)(2) of this section. For lead content of materials that 
are provided as a range, the maximum content of the range must be used.
    (c) If a coating, as defined in Sec.  143.11, is applied to the 
internal surfaces of a pipe, fitting or fixture component, the maximum 
lead content of both the coating and the alloy must be used to 
calculate the lead content of the component.
    (d) If a liner, as defined in Sec.  143.11, is manufactured into a 
pipe, fitting or fixture, the maximum lead content of the liner must be 
used to calculate the lead content of the component.
    (e) If a fixture contains any media (e.g., activated carbon, ion 
exchange resin) contained in filters, the media are not to be used in 
determining the ``total wetted surface area of the entire product'' in 
paragraph (b) of this section.
    (f) In addition to the definitions of ``lead free'' in paragraphs 
(a) through (e) of this section, no drinking water cooler, which 
contains any solder, flux, or storage tank interior surface, which may 
come into contact with drinking water, is lead free if the solder, 
flux, or storage tank interior surface contains more than 0.2 percent 
lead. Drinking water coolers must be manufactured such that each 
individual part or component that may come in contact with drinking 
water shall not contain more than 8 percent lead while still meeting 
the maximum 0.25 percent weighted average lead content of the wetted 
surfaces of the entire product.


Sec.  143.13   Use prohibitions.

    (a) No person may use any pipe, any pipe or plumbing fitting or 
fixture, any solder or any flux that is not lead free as defined in 
Sec.  143.12 in the installation or repair of:
    (1) Any public water system; or
    (2) Any plumbing in a residential or nonresidential facility 
providing water for human consumption.
    (b) Paragraph (a) of this section shall not apply to leaded joints 
necessary for the repair of cast iron pipes.


Sec.  143.14   State enforcement of use prohibitions.

    As a condition of receiving a full allotment of Public Water System 
Supervision grants under section 1443(a) of the Safe Drinking Water 
Act, States must enforce the requirements of section 1417(a)(1) of the 
Safe Drinking Water Act and Sec.  143.13 through State or local 
plumbing codes, or such other means of enforcement as the State may 
determine to be appropriate.


Sec.  143.15   Introduction into commerce prohibitions.

    (a) No person may introduce into commerce any pipe, or any pipe or 
plumbing fitting or fixture, that is not lead free, except for a pipe 
that is used in manufacturing or industrial processing;
    (b) No person engaged in the business of selling plumbing supplies 
in the United States, except manufacturers, may sell solder or flux 
that is not lead free; and
    (c) No person may introduce into commerce any solder or flux that 
is not lead free, unless the solder or flux bears a prominent label 
stating that it is illegal to use the solder or flux in the 
installation or repair of any plumbing providing water for human 
consumption.


Sec.  143.16   Exemptions.

    The prohibitions in Sec. Sec.  143.13 and 143.15 and the product 
certification requirements in Sec.  143.19 shall not apply to the 
products listed in paragraphs (a) through (c) of this section:
    (a) Pipes, pipe fittings, plumbing fittings, or fixtures, including 
backflow preventers, that are used exclusively for nonpotable services 
such as manufacturing, industrial processing, irrigation, outdoor 
watering, or any other uses where the water is not anticipated to be 
used for human consumption. Additional products that could be ``used 
exclusively for nonpotable services'' include:

[[Page 54258]]

    (1) Products that are clearly labeled, on the product, package, or 
tag with a phrase such as: ``Not for use with water for human 
consumption'' or another phrase that conveys the same meaning in plain 
language;
    (2) Products that are incapable of use in potable services (e.g., 
physically incompatible) with other products that would be needed to 
convey water for potable uses; or
    (3) Products that are plainly identifiable and marketed as being 
solely for a use other than the conveyance of water (these other uses 
include conveyance of air, chemicals other than water, hydraulic 
fluids, refrigerants, gasses, or other non-water fluids).
    (b) Toilets, bidets, urinals, fill valves, flushometer valves, tub 
fillers, shower valves, fire hydrants, service saddles, and water 
distribution main gate valves (provided that such valves are 2 inches 
in diameter or larger).
    (c) Clothes washing machines, emergency drench showers, emergency 
face wash equipment, eyewash devices, fire suppression sprinklers, 
steam capable clothes dryers, and sump pumps.


Sec.  143.17   [Reserved]


Sec.  143.18   Required labeling of solder and flux that is not lead 
free.

    Solder and flux that is not ``lead free'' as defined in Sec.  
143.12(a)(1) must bear a prominent label stating that it is illegal to 
use the solder or flux in the installation or repair of any plumbing 
providing water for human consumption.


Sec.  143.19   Required certification of products.

    (a) Manufacturers or importers that introduce into commerce 
products that must meet the lead free requirements of section 1417 of 
the Safe Drinking Water Act and Sec.  143.12 must ensure, except as 
provided in paragraphs (a)(1) through (3) of this section, that the 
products are certified to be in compliance as specified in paragraphs 
(b) and (c) of this section by September 1, 2023, or prior to product 
introduction into commerce, whichever occurs later. Such manufacturers 
or importers must maintain documentation to substantiate the 
certification for at least 5 years from the date of the last sale of 
the product by the manufacturer or importer.
    (1) Product components of assembled pipes, fittings, or fixtures do 
not need to be individually certified if the entire product in its 
final assembled form is lead free certified.
    (2) Direct replacement parts for previously installed lead free 
certified products do not need to be individually certified if the 
weighted average lead content of wetted surface area for the part does 
not exceed such lead content of the original part.
    (3) Dishwashers do not need to be certified.
    (b) Certification of products must be obtained by manufacturers or 
importers from an accredited third party certification body, except as 
provided in paragraph (c) of this section. 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, of dates of certification, and of expiration. This 
documentation must be provided upon request to the Administrator as 
specified in Sec.  143.20(b).
    (c) Products may be self-certified by manufacturers or importers as 
provided in paragraph (c)(1) or (c)(2) of this section. Such 
manufacturers or importers electing to self-certify products must 
comply with paragraphs (d) through (g) of this section.
    (1) Manufacturers having fewer than 10 employees, or importers 
entering products purchased from or manufactured by manufacturers 
having fewer than 10 employees, may elect to self-certify products in 
lieu of obtaining certification from an accredited third party 
certification body. The number of employees includes any persons 
employed by the manufacturer and any of its affiliated entities. The 
number of employees must be calculated by averaging the number of 
persons employed, regardless of part-time, full-time, or temporary 
status, by an entity and all of its affiliated entities for each pay 
period over the entity's latest 12 calendar months or averaged over the 
number of months in existence if less than 12 months. Any such firms 
that subsequently expand employment to 10 or more employees, based on 
the most recent 12-month average number of persons employed, are no 
longer eligible to self-certify products and must obtain third party 
certification within 12 months of having 10 or more employees.
    (2) Manufacturers or importers may elect to self-certify any custom 
fabricated product in lieu of obtaining certification from an ANSI 
accredited third party certification body, regardless of the number of 
persons employed by the manufacturer.
    (d) In order for eligible manufacturers or importers to self-
certify products, such manufacturers or importers must attest that 
products are in compliance with the definition of ``lead free'' in 
Sec.  143.12 by developing and maintaining a ``certificate of 
conformity.'' The certificate of conformity must be:
    (1) Signed by a responsible corporate officer; a general partner or 
proprietor; or an authorized representative of a responsible corporate 
officer, general partner, or proprietor; and
    (2) Posted to a website with continuing public access in the United 
States, unless it is distributed by other means (e.g., electronically 
or in hard copy) with the product through the distribution channel for 
final delivery to the end use installer of the product.
    (e) The certificate of conformity must be in English and include:
    (1) Contact information for the manufacturer or importer to 
include:
    (i) The entity or proprietor name;
    (ii) Street and mailing addresses;
    (iii) Phone number; and
    (iv) Email address;
    (2) For products imported into the United States, the contact 
information must also be included for the manufacturer;
    (3) A brief listing of the products to include, when applicable, 
unique identifying information such as model names and numbers;
    (4) A statement attesting that the products meet the lead free 
requirements of the Safe Drinking Water Act and 40 CFR part 143, 
subpart B, and also that the manufacturer or importer is eligible to 
self-certify the product consistent with this regulation;
    (5) A statement indicating how the manufacturer or importer 
verified conformance with the Safe Drinking Water Act and 40 CFR part 
143, subpart B; and
    (6) The signature, date, name, and position of the signatory; and, 
if the signatory is an authorized representative of a responsible 
corporate officer, a general partner, or a proprietor, the name and 
position of the officer, partner, or proprietor.
    (f) Manufacturers or importers that self-certify products 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 this subpart. Sufficient 
documentation may include detailed schematic drawings of the products 
indicating dimensions, records of calculations of the weighted average 
lead content of the product, documentation of the 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 Sec.  143.20(b) and must be maintained

[[Page 54259]]

for at least five (5) years after the last sale of the product by the 
manufacturer or importer.
    (g) The certificate of conformity and documentation must be 
completed prior to a product's introduction into commerce.


Sec.  143.20   Compliance provisions.

    (a) Noncompliance with the Safe Drinking Water Act or this subpart 
may be subject to enforcement. Enforcement actions may include seeking 
injunctive or declaratory relief, civil penalties, or criminal 
penalties.
    (b) The Administrator may, on a case-by-case basis, request any 
information, such as records deemed necessary to determine whether a 
person has acted or is acting in compliance with section 1417 of the 
Safe Drinking Water Act and this subpart. Information, such as records 
requested, must be provided to the Administrator at a time and in a 
format as may be reasonably determined by the Administrator.

[FR Doc. 2020-16869 Filed 8-31-20; 8:45 am]
BILLING CODE 6560-50-P