[Federal Register Volume 85, Number 170 (Tuesday, September 1, 2020)]
[Rules and Regulations]
[Pages 54235-54259]
[FR Doc No: 2020-16869]

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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.

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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.

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<PHONE_NUMBER>, 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_ADDRESS>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

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

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

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

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

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

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

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.

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

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

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

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

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.

                                     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).

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

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).

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

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