[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Proposed Rules]
[Pages 4805-4825]
[FR Doc No: 2017-00743]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 141 and 143

[EPA-HQ-OW-2015-0680; FRL-9958-23-OW]
RIN 2040-AF55

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) proposes to make
conforming changes to existing drinking water regulations based on the
Reduction of Lead in Drinking Water Act of 2011 (RLDWA) and the
Community Fire Safety Act of 2013 (CFSA). Section 1417 of the Safe
Drinking Water Act (SDWA) prohibits the use and introduction into
commerce of certain plumbing products that are not lead free. The RLDWA
revised the definition of lead free to lower the allowable maximum lead
content from 8.0 percent to a weighted average of 0.25 percent of the
wetted surfaces of plumbing products and established a statutory method
for calculating lead content. In addition, the RLDWA created exemptions
from the lead free requirements for plumbing products that are used
exclusively for nonpotable services as well as for other specified
products. The CFSA further amended section 1417 to exempt fire hydrants
from these requirements.
    EPA proposes to establish new requirements to assure that
individuals purchasing, installing or inspecting potable water systems
can identify lead free plumbing materials. Specifically, EPA proposes
to establish labeling requirements to differentiate plumbing products
that meet the lead free requirements from those that are exempt from
the lead free requirements and to require manufacturers to certify
compliance with the lead free requirements. These proposed requirements
would reduce inadvertent use of non-lead free plumbing products in
potable use applications and, consequently, reduce exposure to lead in
drinking water and associated adverse health effects.

DATES: Comments must be received on or before April 17, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2015-0680, to the Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or withdrawn. EPA
may publish any comment received to its public docket. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. EPA will generally not consider comments or comment contents
located outside of the primary submission (i.e., on the web, cloud, or
other file sharing system).
    For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

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.

SUPPLEMENTARY INFORMATION:

Abbreviations and Acronyms

AFS--American Foundries Society
ANSI--American National Standards Institute
CFSA--Community Fire Safety Act of 2013
CFR--Code of Federal Regulations
FAQs--Frequently Asked Questions
O&M--Operations and Maintenance
NAICS--North American Industry Classification System
NSF--NSF International
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 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. Proposed Regulatory Provisions
    A. Scope/Applicability of Proposed Rule
    B. Labeling of Potable Use Products
    C. Exempt Products
    D. Product Certification
    E. Other Regulatory Requirements and Clarifications
    F. Implementation
V. Costs
    A. Initial Administrative and Initial Implementation Costs
    B. Labeling Potable Use Products
    C. Labeling Products Eligible for the ``Used Exclusively''
Exemption
    D. Product Certification
    E. Response to EPA Data Request Costs
    F. Other Regulatory Requirements and Clarifications
VI. Economic Impacts Analysis
    A. Annualized Social Costs Estimates
    B. Economic Impacts--Cost-to-Revenue Analysis
VII. Benefits
VIII. Statutory and Executive Orders Reviews
IX. References

I. General Information

A. Does this action apply to me?

    The statutory prohibitions on use and introduction into commerce of
certain products that are not lead free codified by this rule apply to
``any person'' as defined in the Safe Drinking Water Act (SDWA). This
rule implementing those provisions applies to any person who would
introduce plumbing products into commerce, such as manufacturers,
importers, wholesalers, distributors, re-sellers, retailers, and to any
person who would use plumbing products in a public water system or in a
residential or non-residential facility providing water for human
consumption. 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 proposing this regulation to codify revisions to the SDWA
prohibition on use and introduction into commerce of certain products
that are not lead free (hereafter termed the SDWA lead prohibitions) as
enacted in the Reduction of Lead in Drinking Water Act of 2011 (RLDWA)
and the Community Fire Safety Act of 2013 (CFSA). EPA is also proposing
requirements to certify and label plumbing products introduced into
commerce to assure they are lead free.
    SDWA 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 non-residential facility providing water for human
consumption, that is not lead free'' as defined in section 1417(d).
Section 1417(a)(3) 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 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 lead free products be in
compliance with voluntary standards established in accordance with SDWA
1417(e) for leaching of lead from new plumbing fittings and fixtures.
In addition, the RLDWA created exemptions in SDWA section 1417(a)(4)
from the prohibitions on the use or introduction into commerce 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 1417(a)(4)(A)), as well as 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
1417(a)(4)(B)). The CFSA further amended section 1417 to exempt fire
hydrants.
    In addition to codifying the revised requirements under RLDWA and
CFSA, EPA is proposing product certification requirements and data
gathering authorities to ensure consistent implementation and
enforcement of the SDWA lead prohibition, as well as new labeling
requirements to assure that individuals purchasing, installing or
inspecting potable water systems can identify lead free plumbing
materials. Specifically, EPA proposes to establish labeling
requirements to differentiate plumbing products that meet the lead free
requirements from those that are exempt from the lead free requirements
and to require manufacturers to certify compliance with the lead free
requirements. These proposed requirements would reduce inadvertent use
of non-lead free plumbing products in potable use applications and,
consequently, reduce exposure to lead in drinking water and associated
adverse health effects.
    The goals of these proposed regulatory provisions are to limit
accidental lead exposure by clearly identifying those products to be
used or not used for potable services; and to ensure that plumbing
products that are identified as lead free for use in potable services
meet the requirements of the SDWA lead prohibition.

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

    EPA's authority for this proposed rule is sections 1417, 1445 and
1450 of the SDWA, 42 U.S.C. 300j-6, 300j-4, and 300j-9. SDWA section
1417 authorizes the EPA Administrator to ``prescribe such regulations
as are necessary or appropriate to carry out his/her functions under
this subchapter.'' 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. This proposed rule would amend those
regulations to reflect the current law. In addition, because the RLDWA
created exemptions from the use prohibition in section 1417(a)(1) and
the introduction into commerce prohibition in section 1417(a)(3), EPA
proposes additional regulations to aid in the implementation and
enforcement of these prohibitions.

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

    EPA conducted an incremental compliance cost analysis of this
proposed rule. For detail on the cost analysis see sections V and VI of
this notice. The Technical Support Document (USEPA, 2016) prepared for
this proposed rule and available in the docket for this proposed rule
contains the detailed description of the cost assessment. EPA did not
conduct a quantified and monetized benefits analysis, but a qualitative
discussion of the benefits attributable to this rule can be found in
section VII and in the Technical Support Document.
    Total annualized costs for the proposed rule range from $12 million
discounted at three percent to $18 million discounted at seven percent.
These costs include administrative requirement costs, the cost to
potable use product manufacturers for both labeling on the product and
on the product's packaging, the cost to manufacturers employing the
``used exclusively'' exemption for package labeling indicating non-
potable uses, third party and self-certification costs and the costs of
responding to EPA data requests.
    The proposed rule would reduce inadvertent use of non-lead free
plumbing products in potable use applications and, as a result, would
reduce exposure to lead in drinking water. The benefits of this
proposed rule would be the resulting incremental reduction in the
adverse health effects of low doses of lead, which include adverse
neurological, cardiovascular, renal, reproductive, developmental,
immunological and carcinogenic effects.

II. Background

    Lead can be introduced into drinking water by corrosion of plumbing
products (pipes, pipe and plumbing fittings and fixtures, solder, and
flux). Lead exposure causes damage to the brain and kidneys, and can
interfere with the production of red blood cells that carry oxygen to
all parts of the body. The greatest risk associated with lead exposure
is to infants, young children and pregnant women. Scientists have
linked the effects of lead on the brain with lowered IQ in children.
    In 1986, Congress amended the SDWA to prohibit the use of pipes,
solder or flux that are not ``lead free'' in public water systems or
plumbing in facilities providing water for human consumption. At the
time, lead free was defined as solder and flux with no more than 0.2
percent lead and pipes with no more than 8.0 percent lead.
    In 1996, Congress further amended the SDWA to prohibit the use of
pipe and plumbing fittings and fixtures that are not lead free in the
installation and repair of any public water system or plumbing in a
facility providing water for human consumption. The 1996 amendments
also required lead free plumbing fittings and fixtures (endpoint
devices) to be in compliance with a lead leaching standard established
in accordance with section 1417(e).
    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, and
eliminated the requirement that lead free products be in compliance
with standards established in accordance with SDWA section 1417(e) for
leaching of lead from new plumbing fittings and fixtures.
    The 2011 RLDWA also established two types of exemptions from the
section 1417 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 non-potable 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 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
1417(a)(4)(B)). The RLDWA established a prospective effective date of
January 4, 2014, which provided a three-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 provided a
summary of the requirements of the lead ban provisions in SDWA section
1417 and answers to frequently asked questions (FAQs) related to the
amendments to assist manufacturers, retailers, plumbers and consumers
in understanding the changes to the law (USEPA, 2013a). In this FAQ
document, EPA stated its intention to further evaluate and refine the
issues raised in the FAQ in a future rulemaking.

III. Summary of Data Used

A. Characterization of the Affected Industry

    A number of data sources were used 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 non-potable 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 proposed rule.
These data were supplemented with information from a number of
additional sources. Dun & Bradstreet data were obtained for those firms
that were identified by North American Industry Classification System
(NAICS) and Standard Industrial Classification (SIC) code
classifications as potentially producing plumbing products that would
be affected by the proposed 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. Additional
information was gathered from the Plumbing Manufacturers International
(PMI) Web site, 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. The Technical
Support Document (USEPA, 2016) contains more information and data
sources used and is available in the docket.

B. Determining Baseline Industry Practices and Potential Costs of
Compliance

    EPA conducted calls with representatives of both the PMI and the
American Foundries Society (AFS) industry associations and held a
stakeholder webinar in 2015 in order to obtain information on current
practice 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, the two
industry associations 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, data were obtained from a number of independent
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 proposed rule. EPA also contacted the eight firms currently
accredited to certify plumbing components for compliance with NSF/ANSI
Standard 372, for information on the cost of certification and the
technical process for testing and certifying products as meeting the
standard.

IV. Proposed Regulatory Provisions

A. Scope/Applicability of Proposed Rule

    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
proposal would apply 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 is 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 any public water system or any plumbing
in a residential or nonresidential facility or location that provides
water for human consumption.
    EPA solicits comments on all aspects of the proposed approach set
forth in this notice. EPA specifically solicits comments, information
and data on the following topics:
    1. In order to clarify the requirements, set forth in the RLDWA and
this proposal, EPA defined terms, 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 the proposed rule. EPA
requests comment concerning the appropriateness of these definitions
and any additional terms that should be defined, specifically terms
describing exempt products included in section 1417(a)(4)(B) of the
SDWA (e.g., water distribution main gate valve).
    2. 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 no more
than 8 percent lead'' except that any solder, flux or storage tank
interior surface may not contain more than 0.2 percent lead. 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 also a ``fixture'' under section 1417 of the
SDWA; and, therefore, subject to the definition of lead free in section
1417. To give effect to both provisions, in practice, drinking water
coolers would need to comply with the most restrictive of the
requirements in sections 1417 and 1461 of the SDWA. For clarity, EPA
could consider addressing the requirements of section 1461 in the final
rule by inserting language such as: ``In addition to the definitions of
``lead-free'' in Sec.  143.12(a)(1) and (2), 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.'' Should EPA consider adding such a
provision to the rule?
    3. The regulatory modifications in this proposal are designed, in
part, to make the requirements set forth in section 1417 of the SDWA
clearer and easier to implement and enforce in a consistent manner. Are
additional clarifications needed to improve the regulation? If so, what
specific clarifications are needed?

B. Labeling Potable Use Products

    EPA evaluated several options concerning labeling of products that
comply with the definition of lead free, including a requirement to
label a product's packaging, physically marking a product, or a
combination of both. EPA found that many manufacturers already utilize
a combination of package and product labeling to inform product users
that the products comply with the RLDWA and several similar state laws.
In an effort to reduce consumer confusion and establish a consistent
labeling scheme for these products, EPA proposes 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 (in a type approximately 8 point to 14 point
depending on the method of marking and roughness of product surface).
Direct product marking to indicate lead free status will assist
building inspectors in verifying that installations are in compliance
with plumbing codes and allow for identification of products if they
become separated from packaging prior to installation. Separation from

packaging is likely to occur when used products are salvaged and sold
or reused. After a product has been installed, a marking on the product
itself will aid inspectors in identifying products that are lead free.
In the long term, product marking to indicate lead free status will
help the metals recycling industry segregate scrap materials that may
be used to produce future products with low lead content.
    This proposal provides that products that are too small to be
marked on the product would be exempt from product marking, but would
still need to comply with package, container or tag labeling. Also,
when marking a product directly, the manufacturer should, to the extent
practical, locate the marking in an area where it would be visible
after installation. For those products where visual aesthetics is a
factor in marketing and selling the product, the manufacturer may
locate the marking in a manner that will not negatively impact the
design.
    EPA is not proposing a specific phrase be required on products or
packages, but rather a performance standard that the phrase clearly
conveys to users that the product is in compliance with the lead free
requirements of the SDWA. The proposed regulation would include these
examples of acceptable phrases for packaging: ``This product conforms
to the lead free requirements of the SDWA,'' or ``Lead Free.'' Examples
of acceptable product markings include: ``Lead Free,'' ``LF,'' or
appropriate third party certification markings such as NSF/ANSI 372.
    The requirements EPA proposes for lead free products will ensure
that purchasers of plumbing products do not inadvertently use products
that are not lead free, or re-introduce them into commerce for potable
applications (e.g., in the case of a distributor, wholesale supplier,
retailer). In addition to the package and product labeling requirement
set forth in this proposal, EPA also considered requiring that either
the product be marked or the package be labeled, but not both. While
this option would decrease the costs and burden on the manufacturer
responsible for labeling and marking, EPA is concerned that this option
may not provide consumers and others (such as building inspectors) with
the information needed to determine that a product is lead free after
its initial purchase and installation. If a product is removed from its
packaging and stored prior to installation, or if a regulatory body is
looking for confirmation after installation that the product meets the
lead free requirements, the package labeling would likely be
insufficient. Similarly, labeling of a product that is sold in an
unlabeled package could also lead to the inadvertent installation of
products that did not meet the new definition of lead free for potable
purposes. For those reasons, labels on both the package and product are
more appropriate (unless the product is too small for a label).
    EPA solicits comments on all aspects of the proposed approach set
forth above. In addition, EPA specifically solicits comments,
information and data on the following topics:
    1. Whether the rule should require the specific phrase ``lead
free'' on package labeling and product markings rather than allowing
some discretion in the use of phrases.
    2. Whether an alternative specific phrase should be required for
product and package labeling and, if so, what phrase.
    3. If a specific phrase such as ``lead free'' were required, what
period of time should be allowed for a transition period to enable
manufacturers to modify their product and packaging to incorporate such
phrase?
    4. If products were required to use a specific phrase such as
``lead free,'' whether that specific phrase should be required on both
the package label and product marking or whether an abbreviated message
should instead be allowed on the product.
    5. Whether the rule should allow for either package labeling or
product marking rather than package labeling and product marking.
    6. Whether the rule should require any package labeling or product
marking.

C. Exempt Products

    As a result of the exemptions created by the RLDWA, there will be
plumbing products in the marketplace that are not required to meet the
definition of lead free in section 1417(d) of the SDWA. Therefore,
without appropriate labeling, there is a risk that non-lead free
products will be inadvertently used in potable water applications or
re-introduced into commerce for potable applications. There are several
points along the distribution chain where EPA anticipates a non-lead
free product could be mistakenly identified as a lead free product,
including the initial sale of the product and at the time of
installation.
    Prior to the RLDWA, all plumbing devices were required to contain
less than 8.0 percent lead, and certain endpoint devices (e.g.,
faucets) were required to meet additional standards for lead leaching.
The exemptions created in the RLDWA allow for certain pipes, fittings
and fixtures to be sold with no limit to the amount of lead they
contain.
    One of the exemptions allows the use and introduction into commerce
of pipes, fittings and fixtures that are used exclusively for
nonpotable services. EPA has determined that a plumbing product that is
physically incompatible with potable drinking water systems, rendering
it impossible to be used for potable service, qualifies for this
exemption.
    In addition, EPA also proposes a second option for manufacturers to
demonstrate that their product is ``used exclusively'' for nonpotable
services and therefore eligible for this exemption (hereafter referred
to in this notice as the ``used exclusively'' exemption). As EPA
explained in the RLDWA FAQs, EPA would generally consider pipes,
fittings or fixtures to be used exclusively for nonpotable services if
they are marketed and sold for use in nonpotable services, and
prominently and clearly labeled as illegal for use in potable services
and not anticipated for use with water for human consumption. This
proposal would codify that interpretation of this exemption by allowing
the use of a package label (or the product marking for those products
sold without an external package) clearly identifying the product as
not for use with water for human consumption. A package label, combined
with the labeling requirements for products that must meet the lead
free requirements (i.e., package labeling and product marking described
in section VI.B of this document and described in Sec.  143.17 of this
proposed rule), should provide consumers with sufficient information to
determine which plumbing products are designed for use with potable
water systems; thus significantly reducing the likelihood of improperly
installing a non-lead free product.
    The products specifically listed as exempt in SDWA section
1417(a)(4)(B) would not be subject to these labeling requirements or
any of the other requirements of this proposal. These products are
exempt from the requirements of this proposal: Toilets, bidets,
urinals, fill valves, flushometer valves, tub fillers, fire hydrants,
shower valves, service saddles or water distribution main gate valves
that are 2 inches in diameter or larger.
    In addition to the specific plumbing devices excluded in the SDWA,
EPA is also proposing to exclude clothes washing machines, fire
suppression sprinklers, eyewash devices, sump pumps and emergency
drench showers, because EPA is not aware of any potable use for these
specific products.

    EPA solicits comments on all aspects of the proposed approach set
forth above. EPA specifically solicits comments, information and data
on the following topics:
    1. This proposal includes two methods of qualifying for the ``used
exclusively for non-potable exemption:'' (a) the product is physically
incompatible with potable water systems, or (b) the packaging is
clearly labeled that it is not for use for water for human consumption.
Are the criteria listed above appropriate for qualifying for the ``used
exclusively'' exemption or are there different or additional criteria
that EPA should consider?
    2. Is there any reason EPA should not extend the used exclusively
for non-potable services exemption to plumbing products that are
physically compatible with drinking water systems?
    3. Will labeling the packaging of pipes, fittings or fixtures as
not for use for water for human consumption be sufficient to inform
consumers of the appropriate use of the product?
    4. In addition to the specific plumbing devices excluded in the
SDWA, EPA is also proposing to exclude clothes washing machines, fire
suppression sprinklers, eyewash devices, sump pumps and emergency
drench showers. EPA is not aware of a potable use for these devices, or
of a potable use product that they could be confused with; and as such,
requiring a label to qualify for the ``used exclusively'' exemption
could be redundant and unnecessary for those devices. Is EPA's
assumption about the lack of a potable use for these specific plumbing
devices appropriate?
    5. Are there other specific plumbing devices for which there are no
potable uses, nor a potable use product they could be confused with
that should be added to the list of excluded products?
    6. EPA is proposing to retain the exemption for leaded joints used
in the repair of cast iron pipes. EPA interprets the introduction into
commerce provision as not prohibiting the sale or distribution of lead
which may be used to form leaded joints used in the repair of cast iron
pipes. Congress did not remove the statutory exemption for these types
of repairs in section 1417(a)(1)(B) in either the 1996 or the 2011
amendments to section 1417 of the SDWA. Therefore, EPA believes that
Congress intended to continue to allow the use of leaded joints
necessary for the repair of cast iron pipes. EPA is seeking comment on
this interpretation of section 1417(a)(1)(B).

D. Product Certification

    EPA is proposing certification requirements for manufacturers and
importers to demonstrate 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 by either third party certification bodies
or self-certification. For products that are required to meet Section
1417's lead free requirements, EPA proposes to require manufacturers
with 100 or more employees or importers representing foreign
manufacturers with 100 or more employees to demonstrate compliance with
the lead free definition by obtaining third party certification by an
American National Standards Institute (ANSI) accredited third party
certification body. EPA proposes to require manufacturers with fewer
than 100 employees or importers 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 below.
    Third party certification is currently required for certain
products in widely adopted model plumbing codes. The most recent
version of the single most widely adopted model plumbing code requires
pipe, pipe fittings, joints, values, 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 must be evaluated by an ANSI accredited third party
certification body. These are independent organizations that test a
product, review a product's manufacturing process and determine that
the product complies with specific standards for safety, quality,
sustainability or performance (i.e., 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 Water Quality Association.
    For manufacturers with fewer than 100 employees and importers
sourcing products from or representing foreign manufacturers with fewer
than 100 employees, the proposed rule provides the flexibility of
allowing these entities to demonstrate product compliance by either
using an ANSI accredited third party certification body or by self-
certification of the products. EPA estimated that manufacturers of
covered products having fewer than 100 employees account for 72 percent
of the total number of such manufacturers, but only produce 5 to 18
percent of the total volume of products. Small manufacturers that opt
for the self-certification option would be required to develop a
``certificate of conformity,'' also known as a declaration 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 or importers electing to self-certify products,
the proposed rule would require the manufacturer to post the
certificate of conformity on a Web page with continuing public access
in the United States.
    As proposed, the certificate of conformity would be required to
include: 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 (i.e., manufacturer has fewer than 100 employees), 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 that
all source materials used in manufacture were confirmed to be less than
0.25 percent lead. This proposal would require manufacturers or
importers using self-certification to maintain sufficient documentation
to confirm that products meet the lead free requirements.
    The proposed certification requirements will further reduce the
likelihood that non-lead free products will either intentionally or
inadvertently be placed into commerce or used in the repair or
installation of any public water system or any plumbing in a facility
providing water for human consumption. In addition, the labeling and
the certification requirements will assist in the enforcement of the
SDWA section 1417(a)(3) prohibition of the introduction into commerce
of pipes, pipe or plumbing fittings or fixtures that are not lead free.
A third party certification requirement leverages the

resources of the third party certifiers as well as the supply chain to
help the market meet the requirements of RDLWA. The self-certification
requirement, which is applicable to manufacturers with fewer than 100
employees, while not as rigorous as a requirement to obtain third party
certification, nonetheless provides an additional assurance that
products sold by those smaller manufacturers are lead free.
    As an alternative to the proposed product certification
requirements previously described, EPA considered requiring all
manufacturers to obtain third party certification for products required
to meet the lead free requirements. A uniform third party certification
requirement would result in a level playing field for all manufacturers
and would also make the marketplace consistent when a consumer is
shopping for pipes, fittings or fixtures. EPA is not proposing this
option because we are concerned about the economic impacts of a
mandatory third-party certification requirement on manufacturers with
fewer than 100 employees. Some of these manufacturers likely produce or
fabricate small quantities of products that may be custom-made for a
single specific use with a customer. A requirement for third party
certification in these instances may be impractical and costly per unit
produced. For those reasons, EPA chose the approach described in this
proposal.
    EPA also considered the option of allowing all manufacturers the
option of electing third party certification or self-certification for
their various products. This option would allow maximum flexibility for
manufacturers and would likely limit financial impacts to firms that
currently do not get their products independently certified. EPA opted
not to propose this approach because we found that (currently) the most
widely used model plumbing codes require many products to be third
party certified, and that there already exists a high level of adoption
of third party standards in the plumbing industry. Additionally,
requiring all but the smallest firms to certify their products using
third party certification bodies would ensure that the vast majority of
products sold in the marketplace are independently verified as lead
free.
    EPA solicits comments on this aspect of the proposed rule,
including EPA's rationale as described in this preamble. In addition,
EPA specifically solicits comments, information and data on the
following topics:
    1. Should third party certification be required of U.S.
manufacturers regardless of the number of employees?
    2. Should U.S. manufacturers have the option of conducting either
third party certification or self-certification for products they
produce?
    3. Is there a need for some manufacturers to have a self-
certification option?
    4. Should third party certification be required of importers of
foreign manufactured plumbing materials regardless of the number of
employees at the foreign manufacturer?
    5. Is there a more appropriate break point (e.g., fewer than 20
employees, fewer than 500 employees based on other categories of Census
Bureau's Statistics of U.S. Businesses) for allowing self-
certification?
    6. Conversely, should all importers of foreign manufactured
plumbing products be eligible for self-certification?
    7. Is the definition of importer in Sec.  143.11 of this proposed
rule adequate to ensure compliance with the proposed requirements?
    8. Are there more appropriate criteria for requiring third party
certification for manufacturers based on classes of products that EPA
should evaluate, such as more complicated multi-component devices (for
example, valves, faucets, pumps, water coolers, etc.), but allowing an
option of self-certification for simple single component plumbing
pieces (for example, elbow joint, gasket, pipe, etc.); or
alternatively, based on whether a product is mass produced or custom
fabricated?
    9. Should self-certification be allowed for all products made by
any manufacturer if the product is composed of a single material such
as pure copper?
    10. For self-certification, is the requirement for a ``certificate
of conformity'' and its proposed content appropriate, or should there
be another process for self-certification or is there other content for
the ``certificate of conformity'' that would be more appropriate?
    11. Should any product certification be required?

E. Other Regulatory Requirements and Clarifications

1. Compliance Information Authority
    In order to effectively enforce the lead free requirements of the
SDWA and the proposed implementing regulations, EPA needs the ability
to obtain, if necessary 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, certification documentation,
purchases/sales dates, and examples of lead free product and/or package
messaging. This proposed rule contains a provision 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
statutory authority contained in section 1445 of the SDWA.
2. State Enforcement of Use Prohibitions
    EPA is proposing language in Sec.  143.14 to codify in regulation
that the SDWA 1417(b) requirement 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 grant allocation. Under SDWA 1417(b)(1), the state
enforcement provision only applies 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 would it apply to
the proposed requirements for labeling and certification.

F. Implementation

    The revised definition of lead free has been in effect since
January 4, 2014, as per the RLDWA and the CFSA. EPA is proposing that
labeling and the product certification requirements contained within
this proposal will be in effect three years from the date the final
regulation is published, consistent with the three-year time period
provided under the RLDWA and CFSA. EPA is also proposing that all other
provisions are effective 30 days after the date the final regulation is
published, because those provisions merely codify statutory provisions
already in effect.
    EPA solicits comments on all aspects of the proposed implementation
period for this proposed rule. EPA specifically requests comments,
information and data on whether three years is an appropriate timeframe
to achieve compliance with the proposed labeling and certification
requirements, or is a different timeframe more appropriate? Is there a
need for a different effective date for any other provisions of the
rule?

V. Costs

    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 and products eligible for the ``used
exclusively'' exemption is 1.3 billion units and 500 million units,
respectively. There are 2,193 firms producing plumbing products
impacted by this proposed 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.2 summarizes the data for the
segment of the industry that produces products eligible for the ``used
exclusively'' exemption. Both tables break production into product
subcategories and provide EPA's estimated annual production values, the
NAICS code assigned 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
----------------------------------------------------------------------------------------------------------------
                                                                                Number of
        Product category                Product name         Units produced       NAICS for       manufacturers
                                                            annually  (2013)       product         for product
----------------------------------------------------------------------------------------------------------------
Pipe and Fittings...............  Copper Tube (<4'' in           233,049,645            332996               213
                                   diameter).
                                  PEX Pipe (<4'' in              348,583,587            326122                27
                                   diameter).
                                  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''        59,287,619            332913                63
                                   in diameter).
                                  Small and Mid-Diameter          58,257,345            326122               143
                                   PVC 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                   1,236,699            333318               713
 Products.                         Residential Water
                                   Filtration Market.
                                  Point-of-use Counter Top            72,857            333318               694
                                   Water Filtration Market.
                                  Point-of-use Under the             261,702            333318               704
                                   Sink Water Filtration
                                   Market.
                                  Point-of-use Faucet              1,707,194            333318               694
                                   Mount 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.
                                  Residential Inline Valve        30,597,771            332919               204
                                   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               133,647            335228                10
                                   Fired Water Heater
                                   Market.
                                  Residential Electric               276,398            335228                19
                                   Tankless Water Heater
                                   Market.
                                  Residential Solar                   21,819            335228                42
                                   Storage Water Heater
                                   Market.
                                  Residential Oil Water               31,692            335228                 1
                                   Heaters.
                                  Commercial Gas Storage              89,706            335228                11
                                   Water Heater Market.
                                  Commercial Electric                 70,071            335228                15
                                   Storage 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            Coffee Makers...........           234,247            333318                40
 Appliances.
Other...........................  Aerator.................        27,167,173            332913                 3
                                  Backflow preventers/                32,202            332913                11
                                   Vacuum 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: Technical Support Document, Exhibits 3-3 and 3-11 (USEPA, 2016).

   Table V.2--Product Subcategories, Production, NAICS and Number of Manufacturers EPA Identified for Products
                                 Eligible for the ``Used Exclusively'' Exemption
----------------------------------------------------------------------------------------------------------------
                                                                                Number of
        Product category                Product name         Units produced       NAICS for       manufacturers
                                                             annually (2013)       product         for product
----------------------------------------------------------------------------------------------------------------
Pipe and Fittings...............  Copper Tube (<4'' in            81,033,435            332996               213
                                   diameter).
Pipe and Fittings Faucets and     PEX Pipe (<4'' in               59,116,515            326122                27
 Mixers.                           diameter).

                                  CPVC Pipe (<4'' in              39,876,190            326122                48
                                   diameter).
                                  Copper Fittings (<4'' in        32,413,374            332913               119
                                   diameter).
                                  Brass Fittings (<4'' in         27,825,836            332913               523
                                   diameter).
                                  PEX Fittings (<4'' in           16,894,630            332913                47
                                   diameter).
                                  CPVC Pipe Fittings (<4''        15,950,476            332913                63
                                   in diameter).
                                  Small and Mid-Diameter          68,389,058            326122               143
                                   PVC Pipe.
                                  PVC Pipe Fittings.......        35,048,024            332913               103
                                  Laundry Faucet..........         1,122,594            332913                72
Stop Valves, Stainless Steel      Stop Valve Market.......        62,175,887            332911                23
 Braided Hoses, Inline Valves.
Stop Valves, Stainless Steel      Stainless Steel Braided        106,928,024            333999               204
 Braided Hoses, Inline Valves,     Hose Market.                    1,122,594            332913                 3
 Other.                           Aerator.................
Other...........................  Backflow preventers/                79,265            332913                11
                                   Vacuum Breakers.
                                  Gaskets/O-rings.........           224,519            339991                13
                                  Pumps...................            21,914            333911                19
----------------------------------------------------------------------------------------------------------------
Source: Technical Support Document, Exhibits 3-6 and 3-12 (USEPA, 2016).

    EPA developed cost estimates for this proposed rule along with two
additional regulatory alternatives EPA considered in the development of
the proposal. All three regulatory options contain estimates for
initial administrative and implementation costs, costs to modify their
product and/or package messaging, third party or self-certification
costs, and response to data request costs. The three options are
presented in Table V.3. Option B is the regulatory option selected for
this proposal. The Technical Support Document (USEPA, 2016) provides
more detailed information on the costing methodology and a discussion
of the uncertainties and limitations of this assessment.

                      Table V.3--Regulatory Options
------------------------------------------------------------------------
               Option                         Option description
------------------------------------------------------------------------
A..................................   Product labels and package
                                      marking for potable use products.
                                      Third party certification
                                      required for all firms.
B..................................   Product labels and package
                                      marking for potable use products.
                                      Self-certification or
                                      third party certification for <100
                                      Employees; Third party
                                      certification only for >=100
                                      Employees.
C..................................   Product labels or package
                                      marking 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. These costs do
not vary by regulatory option. EPA estimated that it would take each
firm an average of 8 hours to read and understand the rule once
promulgated. This time estimate when multiplied by an average labor
rate of $71.72 and the number of firms affected by the rule, 2,193,
gives a total cost of $1.26 million.
    EPA also estimated the cost to manufacturing firms that would have
to redesign their product and/or package messaging to include lead-
related information. To calculate the cost of package and product
messaging redesign, EPA first estimated the total number of product
types across 46 product subcategories. A total of 5,705 product types
were identified. EPA estimated a percent range of firms that would be
required to redesign their product and package in order to comply with
this proposed rule. Firms with greater than 500 employees are estimated
to redesign 10 percent of product and package messaging. Manufacturers
with fewer than 500 employees are assumed to redesign between 25 and 50
percent of their product and package messaging. Redesign was estimated
to require 5 hours of labor multiplied by the number of products,
giving a total costs range between $0.24 and $0.47 million.
    Table V.4 summarizes, by size category, the initial rule
implementation annualized cost ranges. 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 $0.08 to $0.14
million.

                             Table V.4--Rule Initial Administrative and Initial Implementation Annualized Costs, in Millions
                                                                         [2014$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Read and understand the rule       Messaging design change       Initial rule implementation
                                                         ----------------------------------------------------------------              cost
                                                                   Discount rate                   Discount rate         -------------------------------
          Manufacturer size (no. of employees)           ----------------------------------------------------------------          Discount rate
                                                                                -------------------------------
                                                                3%              7%              3%              7%              3%              7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
<100....................................................          $0.051          $0.073    $0.011-0.021     $0.015-0.03    $0.061-0.072    $0.088-0.103
100-499.................................................           0.001           0.016     0.002-0.005     0.003-0.007     0.014-0.016     0.020-0.023
>=500...................................................           0.008           0.012     0.001-0.001     0.001-0.001     0.009-0.009     0.013-0.013
All Sizes...............................................            0.07           0.101     0.014-0.027      0.02-0.038     0.084-0.097     0.121-0.139
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Technical Support Document, Exhibits 4-7a and 4-7b (USEPA, 2016).

B. Labeling Potable Use Products

    In order to estimate the potential cost of this proposed rule and
the two alternative regulatory scenarios presented in this proposed
rule preamble, EPA collected information on current labeling practices
to set the regulatory baseline. EPA developed three baseline scenarios
characterizing the proportion of firms by size category that either
currently have lead free labeling (meeting the requirements of this
proposed rule), have product messaging not related to lead free
requirements, or have no product messaging. These three scenarios
capture the uncertainty surrounding EPA's understanding of current
industry labeling practices. Table V.5 presents preexisting labeling
assumptions that represent the lower bound for regulatory cost
estimates. Table V.6 shows a possible lower level baseline of product
labeling. This table represents the upper bound for rule cost estimate.
Across both lower and upper bound scenarios, EPA has made the
conservative assumption that 5 percent of all firms have no messaging
on product or package. Also common across the scenarios, is the concept
that firms with greater numbers of employees have larger production
totals and serve larger market areas and, therefore, will have a higher
probability of selling in markets that already require lead content
labeling on product and package. The upper bound scenario assumes
manufacturers with fewer than 500 employees mark products with lead
content messaging 50 percent of the time, while in the lower bound
scenario, those same firms label 75 percent of products with lead
content messaging. Also, firms in the upper bound scenario with less
than 100 employees mark 50 percent of their packaging with lead content
labeling. The lower bound assumes that firms with fewer than 100
employees label 75 percent of packaging with lead content information.

                               Table V.5--Estimated Percentage of Potable Use Products With and Without Existing Messaging
                                                                      [Lower bound]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Percent with lead-content         Percent with existing         Percent with no messaging
                                                                     messaging            messaging but not lead-related   (incur total messaging costs)
                                                         --------------------------------    (incur partial messaging    -------------------------------
        Manufacturer size  (number of employees)                                                      costs)
                                                              Product         Package    --------------------------------     Product         Package
                                                                                Product         Package
--------------------------------------------------------------------------------------------------------------------------------------------------------
<100....................................................              75              75              20              20               5               5
100-499.................................................              75              90              20               5               5               5
>=500...................................................              90              90               5               5               5               5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Technical Support Document, Exhibit 4-8a (USEPA, 2016).

                               Table V.6--Estimated Percentage of Potable Use Products With and Without Existing Messaging
                                                                      [Upper bound]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Percent with lead-content         Percent with existing         Percent with no messaging
                                                                     messaging            messaging but not lead-related   (incur total messaging costs)
                                                         --------------------------------    (incur partial messaging    -------------------------------
        Manufacturer size  (number of employees)                                                      costs)
                                                              Product         Package    --------------------------------     Product         Package
                                                                                Product         Package
--------------------------------------------------------------------------------------------------------------------------------------------------------
<100....................................................              50              50              45              45               5               5
100-499.................................................              50              90              45               5               5               5
>=500...................................................              90              90               5               5               5               5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Technical Support Document, Exhibit 4-8b (USEPA, 2016).

    Using the assumptions on current industry messaging practices
detailed in Tables V.5 and V.6, EPA applied its unit compliance
technology costs for both product and package labeling in the following
way: (1) Firms that currently have lead content messaging on both
product and package are assumed to have no labeling costs in this
regulatory analysis; (2) manufacturers that currently mark their
product and/or package with some messaging (e.g., company name and
marketing materials, a description of how the product is used,
installation instructions or other certification and identification
information) were assigned a partial cost to implement the requirements
of this proposed rule; and (3) firms assumed to have no product
labeling on package or product received full capital and O&M

costs as part of the regulatory assessment of costs.
    Under regulatory options requiring lead free marking on potable use
products, EPA assigned to each of the 40 identified product
subcategories one of three compliance technologies: Printing on product
(e.g., copper or plastic pipe), modification of production molds and
patterns through the use of electric diode machining (e.g., brass
fittings), or attaching a tag with wire or another non adhesive method
(e.g., water heaters).\1\
---------------------------------------------------------------------------

    \1\ Small products like gaskets and o-rings are assumed to be
bagged with lead free messaging.
---------------------------------------------------------------------------

    For regulatory costing scenarios that required lead free labeling
on product packages, EPA (again) assigned one of three compliance
technologies to each of the 40 potable use product categories. The
compliance technologies are printing on product box (e.g., faucets),
printing on product bag (e.g., copper and brass fittings), or adhesive
label (e.g., braided steel hose).\2\
---------------------------------------------------------------------------

    \2\ Products that are not sold with packaging like pipe are
assumed to comply by printing on product.
---------------------------------------------------------------------------

    Unit capital and O&M costs for each of the six compliance
technologies were derived with information collected from both the PMI
and AFS trade associations and information from tool and die firms,
product packaging vendors, and printing equipment suppliers.
    Table V.7 provides EPA's estimated total annual cost ranges for
potable use product lead free messaging on product and/or package for
the three options considered as part of the regulatory analysis. For
Options A and B, costs include labeling on both the product and package
and range from $8.69 to $13.60 million (2014$) dollars annually. For
Option C, which gives producers the choice to label the product or
package, EPA assumed that impacted firms would choose the lower cost
package labeling alternative; therefore, annual costs range from $1.14
to $1.28 million dollars.

 Table V.7--Total Annualized Present Value Costs for Lead Free Labeling
        of Potable Use Products on Product and Package, Millions
                                 [2014$]
------------------------------------------------------------------------
                                   3% Discount rate    7% Discount rate
             Option                   in millions         in millions
                                        (2014$)             (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: Product or package messaging.           1.17-1.28           1.14-1.26
------------------------------------------------------------------------
Source: Technical Support Document, Exhibits 4-13a and 4-13b (USEPA,
  2016).

C. Labeling of Products Eligible for the ``Used Exclusively'' Exemption

    As discussed in section IV.C, EPA has included an additional means
of qualifying for the ``used exclusively'' exemption.
    The proposed provision to label products to establish that the
products are ``used exclusively'' in nonpotable services provides a
less costly option to persons introducing the product into commerce. If
the proposed regulations limited the availability of the ``used
exclusively'' exemption to products that are physically incompatible
with potable water systems, then persons introducing non-potable water
plumbing products into commerce that are physically compatible and
capable of being connected to systems providing water for human
consumption would be required to assure that these products meet the
lead free requirements. Alternatively, they could or redesign their
products to make them physical incompatible with potable water systems.
EPA anticipates that the costs associated with designing and applying a
label are likely to be less than the costs associated with
reformulating the alloy and overhauling the manufacturing processes
associated with meeting the ``lead free'' requirements. Therefore, this
optional compliance alternative will not result in increased costs or
burden, and will result in a cost savings for those manufacturers who
elect to take advantage of this proposed optional exemption mechanism.
    There are six product subcategories that are both physically
compatible with potable use applications and would meet the lead
content limit of 0.25 percent of wetted surfaces to be considered lead
free. In order to develop costs for this requirement EPA first
determined the baseline current industry practices when it comes to
labeling products eligible for the ``used exclusively'' exemption and
their packaging. Table V.8 shows the lower bound percentage of products
by firm size category that currently use lead content messaging,
messaging of some kind (e.g., marks, serial numbers, installation
instructions), and have no labeling on product or packaging. Table V.9
details the upper bound baseline assumed percentages for labeling by
firm size for products eligible for the ``used exclusively'' exemption.

               Table V.8--Estimated Percentage of Products Eligible for ``Used Exclusively'' Exemption With and Without Existing Messaging
                                                                      [Lower bound]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Percent with lead-related         Percent with existing         Percent with no messaging
                                                                     messaging            messaging but not lead-related   (incur total messaging costs)
                                                         --------------------------------    (incur partial messaging    -------------------------------
         Manufacturer size (number of employees)                                                      costs)
                                                            Product (%)     Package (%)  --------------------------------   Product (%)     Package (%)
                                                                                Product (%)     Package (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
<100....................................................              50              50              45              45               5               5
100-499.................................................              75              75              20              20               5               5

>=500...................................................              75              75              20              20               5               5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Technical Support Document, Exhibit 4-14a (USEPA, 2016).

               Table V.9--Estimated Percentage of Products Eligible for ``Used Exclusively'' Exemption With and Without Existing Messaging
                                                                      [Upper bound]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Percent with lead-related         Percent with existing         Percent with no messaging
                                                                     messaging            messaging but not lead-related   (incur total messaging costs)
                                                         --------------------------------    (incur partial messaging    -------------------------------
         Manufacturer size (number of employees)                                                      costs)
                                                            Product (%)     Package (%)  --------------------------------   Product (%)     Package (%)
                                                                                Product (%)     Package (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
<100....................................................              25              25              70              70               5               5
100-499.................................................              50              50              45              45               5               5
>=500...................................................              50              50              45              45               5               5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Technical Support Document, Exhibit 4-14b (USEPA, 2016).

    EPA assumed manufacturers of products eligible for the ``used
exclusively'' exemption that currently do not have lead-related
information on their product would use the same compliance technologies
that would be used for the labeling of potable use products and
packages. For labeling on the product, EPA assigned each of the
subcategories as either the printing on product or the mold
modification compliance technology.\3\ Also, for package compliance,
EPA assigned the print on bag compliance technology. Under the ``used
exclusively'' exempt package marking requirements, piping products are
required to be printed directly on the product since they are generally
not packaged.
---------------------------------------------------------------------------

    \3\ Small products like gaskets and o-rings are assumed to be
bagged with lead free messaging.
---------------------------------------------------------------------------

    EPA used the same unit cost information that was developed for the
potable use labeling requirements. Table V.10 details, by size
category, the regulatory annual total cost ranges for labeling those
products eligible for the ``used exclusively'' exemption not for
potable use applications. This cost component does not vary by
regulatory option. Annual total cost for labeling products that are not
for potable use range from $0.14 to $0.22 million.

   Exhibit V.10--Total Annualized Present Value Costs for Lead-Related
Messaging on Products Eligible for the ``Used Exclusively'' Exemption on
                      Package or Product, Millions
                                 [2014$]
------------------------------------------------------------------------
                                   3% Discount rate    7% Discount rate
  Manufacturer size (number of        in millions         in millions
           employees)                   (2014$)             (2014$)
------------------------------------------------------------------------
<100............................         $0.03-$0.03         $0.02-$0.03
100-499.........................           0.01-0.01           0.01-0.01
>=500...........................           0.11-0.17           0.10-0.16
                                 ---------------------------------------
    Total Cost..................           0.15-0.22           0.14-0.20
------------------------------------------------------------------------
Source: Technical Support Document, Exhibit 4-17 (USEPA, 2016), Rule
  Component All Sizes worksheet.

D. Product Certification

    In order 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 collected information on use of third party
certification by plumbing manufacturers by reviewing current state laws
requiring certification for NSF Standard 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 (e.g., NSF International, CSA Group,
UL, etc.). Based on the collected information, EPA assumed that 90
percent of manufacturers with 100 or greater 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 chose to develop 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 certifiers. Table V.11 summarizes the third party
certification baseline assumptions EPA used in the development of
regulatory costs. Under all regulatory options, certification costs
would only be attributable to those manufacturers that do not already
use these third party certification bodies.

  Table V.11--Estimated Percentage of Manufacturers That Do Not Already
                  Use Third Party Certification Bodies
------------------------------------------------------------------------
                                     Percentage of manufacturers that
                                     currently do not use third party
  Manufacturer size (number of        certifying bodies and to which
           employees)                 certification costs would apply
                                 ---------------------------------------
                                   Lower  bound (%)    Upper  bound (%)
------------------------------------------------------------------------
<100............................                  25                  50
100-499.........................                  10                  10
>=500...........................                  10                  10
------------------------------------------------------------------------
Source: Technical Support Document, Exhibit 4-18 (USEPA, 2016).

    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 Web
site data for manufacturers across all potable use product
subcategories.
    Certification costs can be broken 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.
In order 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 certifiers 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. None of the firms provided quotes for all four product lines.
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
Standard 372. Costs varied based on the product type and certification
body. One of the responding certifiers requires re-certification
annually. The other four certification bodies require renewal on a less
frequent basis, the longest being every five years. EPA determined a
five-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.
    Both the preferred proposed rule Option B and Option C allow for
some firms to self-certify compliance with lead free requirements. EPA
estimated that each manufacturer would require 40 hours of labor to
initially develop the certificate of conformity (the requirement of 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. These hours are used to
update the certificate of conformity and perform recordkeeping
activities. This means the unit cost of annual self-recertification is
$449 per product family.
    Table V.12 provides EPA's estimated total annual cost ranges for
potable use product certification requirements of this proposed rule
and other options that were considered. Unit certification costs were
multiplied by the number of firms and average number of product
families. Option A's cost range of $11.20 to $21.58 million reflects a
third party certification requirement for all regulated firms. Option
B, the proposed option, requires third party certification for firms
with 100 or more employees and gives the option of self-certification
to firms with fewer than 100 employees. Annual costs for Option B range
from $2.82 to $4.31 million. The analysis of Option C assumes that all
firms, when given the less costly self-certification choice, will opt
for that compliance path. Therefore, the annual costs that range from
$1.52 to $2.98 million reported here are for all firms conducting self-
certifications. EPA did not assess any cost savings to firms that would
no longer choose to have products third party certified.

  Table V.12--Total Annualized Present Value Costs for Demonstration of
                    Compliance Requirements, Millions
                                 [2014$]
------------------------------------------------------------------------
                                   3% Discount rate    7% Discount rate
             Option                   in millions         in millions
                                        (2014$)             (2014$)
------------------------------------------------------------------------
A: Third party certification           $11.20-$20.90       $11.56-$21.58
 only...........................
B: Third party for >=100; Choice           2.82-4.14           2.93-4.31
 of self-certification for <100
 (Proposed Rule)................
C: Third party certification or            1.52-2.84           1.59-2.98
 self-certification.............
------------------------------------------------------------------------
Source: Technical Support Document, Exhibits 4-23a and 4-23b (USEPA,
  2016).
Note: Under Option C, all manufacturers are assumed to select the less
  costly choice of self-certification.

E. Response to EPA Data Request Costs

    Under all three of the proposed regulatory options, plumbing
manufacturers will be required to respond to EPA's requests for product
information (See section IV.E.1.a 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 $1,434. 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, and firms with fewer than 100 employees would
receive the remaining 10 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.13
shows the total annualized cost of EPA data request response 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.13--Total Annualized Present Value Costs for Responding to Data
                          Requests, in Millions
                                 [2014$]
------------------------------------------------------------------------
  Manufacturer size (number of
           employees)              3% Discount rate    7% Discount rate
------------------------------------------------------------------------
<100............................             $0.0012             $0.0012
100-499.........................              0.0025              0.0024
>=500...........................              0.0087              0.0083
All Sizes.......................              0.0124              0.0119
------------------------------------------------------------------------
Source: Technical Support Document, Exhibit 4-25 (USEPA, 2016).

VI. Economic Impacts Analysis

    EPA assessed the social costs and the projected economic impacts of
the three regulatory options described in this proposal. This section
provides an overview of the methodology EPA used to assess the social
costs and the economic impacts of this proposed rule and summarizes the
results of these analyses. The Technical Support Document (USEPA,
2016), 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 rule's 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, the cost to manufacturers of products eligible for the
``used exclusively'' exemption for package labeling indicating non-
compliance with lead free requirements, 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 on other than an
annual basis were annualized over a specific useful life,
implementation, and/or event recurrence period (i.e., 10 years for mold
modifications), using rates of 3 and 7 percent. EPA added the
annualized capital, initial one-time costs, and the non-annual portion
of O&M costs to annual 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
regulatory options. As shown in the table, total annualized compliance
costs range between $3 million and $36 million for Options C and A,
respectively, with the proposed option (Option B) estimated to have
annualized costs of $12 million to $18 million.

                Table VI.1--Total Annualized Social Costs
                            [Millions, 2014$]
------------------------------------------------------------------------
      Regulatory option \1\        3% Discount rate    7% Discount rate
------------------------------------------------------------------------
A: Label product and packaging/          $20.1-$31.6         $23.1-$35.5
 third party certification......
B: (Proposed Rule): Label                  11.8-14.8           14.5-18.3
 product and packaging/third
 party certification for
 manufacturers >=100 employees
 and third party or self-
 certification for others.......

C: Label product or packaging/               2.9-4.5             3.0-4.6
 third party or self-
 certification..................
------------------------------------------------------------------------
Source: Technical Support Document, Exhibit 4-27 (USEPA, 2016).
\1\ Table includes annualized costs for rule implementation,
  certification of potable use products, lead-related messaging for
  potable use products and products eligible for the ``used
  exclusively'' exemption, and EPA requests for data.

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

    To provide an assessment of the impact of the rule on plumbing
manufacturing firms, EPA used a cost-to-revenue analysis. The cost-to-
revenue analysis compares the total annualized compliance cost of each
regulatory option with the revenue of the impacted entities. This same
analysis is also used under the Regulatory Flexibility Act (RFA) to
determine if a rule has the potential to have a significant impact on a
substantial number of small entities.
    In order to conduct the cost-to-revenue test, EPA developed a list
of 2,193 manufacturers that participate in the production of specific
types of plumbing products for both potable use and those eligible for
the ``used exclusively'' exemption. These firms were assigned to a
NAICS code, based on the type of plumbing 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, the number of firms in each of the 14 NAICS codes having
seven employee size categories each (e.g., 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) was derived.
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 option. In order 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, so 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 to 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 are assumed to be impacted at the 3 percent level.
Impacted firms are 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
three main regulatory options. The table only shows the largest impact
scenarios analyzed, based on upper bound compliance cost estimates, and
using a 7 percent discount rate. For the lower bound cost and 3 percent
discounted impact results see the Technical Support Document (USEPA,
2016). Under Option B, which represents this proposed rule (which
includes costs for rule implementation, potable use labeling costs for
both package and product, labeling of products eligible for the ``used
exclusively'' exemption that do not meet lead free requirements, third
party certification cost for firms with 100 or more employees and third
party or self-certification costs for firm with fewer than 100
employees, and data request costs), EPA estimates that the vast
majority of plumbing manufacturing firms subject to the regulations
will incur annualized costs amounting to less than 1 percent of revenue
(2163 firms, or 98.6 percent of the total 2,193 manufacturers). A total
of 29 firms (2 percent of small firms) had impacts between 1 and 3
percent of revenue, and no small manufacturers had impacts above 3
percent, given the costs estimated for Option B. The analysis of Option
B also found that 1 large entity (0.5 percent of large firms) had
impacts between 1 and 3 percent of revenue, and no large firms were
impacted at the 3 percent revenue threshold.

                         Table VI.2--Summary of Cost-to-Revenue Economic Impact Analysis
            [Upper bound scenario, small entities 7% discount rate, large entities 3% discount rate]
----------------------------------------------------------------------------------------------------------------
                                     Small entities (7% discount rate)       Large entities (3% discount rate)
                                 -------------------------------------------------------------------------------
   Option     Option description         Count \2\          Percentage           Count \2\          Percentage
                      \1\        -------------------------------------------------------------------------------
                                   Total   >=1%    >=3%    >=1%    >=3%    Total   >=1%    >=3%    >=1%    >=3%
----------------------------------------------------------------------------------------------------------------
A...........  Product and          1,976     783      27      40       1     217       1       0     0.5     0.0
               Package Costs for
               Potable Product
               or Package Costs
               for ``Used
               Exclusively''
               Exempt Product,
               3rd Party Cert
               for all
               manufacturers.
B...........  Product and          1,976      29       0       2       0     217       1       0     0.5     0.0
               Package Costs for
               Potable Product
               or Package Costs
               for ``Used
               Exclusively''
               Exempt Product,
               3rd Party Cert
               for >=100
               employees, Self
               or 3rd Party Cert
               for <100
               employees.
C...........  Product or Package   1,976       0       0     0.0     0.0     217       0       0     0.0     0.0
               Costs for Potable
               Product or
               Package Costs for
               ``Used
               Exclusively''
               Exempt Product,
               Self or 3rd Party
               Cert for all
               manufacturers.
----------------------------------------------------------------------------------------------------------------
Source: Technical Support Document, Exhibit 6-7 (USEPA, 2016).
\1\ All options also include implementation and data request costs. For Option B, EPA assumes that manufacturers
  <100 employees choose the least cost option of self-certification. For Option C, EPA assumes all manufacturers
  pick the least cost option of self-certification. In addition, for Option C, EPA assumes manufacturers choose
  the least cost option for labeling, which is usually package labeling except when the products do not have
  packaging.
\2\ Counts of impacted entities are rounded up to 1 if they fall between 0 and 1.

    EPA solicits comments on the economic analysis for this proposed
rule, including EPA's cost analysis and benefits assessment as
described in this preamble and the Technical Support Document (USEPA,
2016) for this proposed rule. Comments are most helpful when
accompanied by specific examples or supporting data.

VII. Benefits

    EPA did not quantify the expected change in health endpoints for
this proposed regulation. EPA assessed the health effects associated
with reductions in lead ingestion qualitatively using two main sources:
(1) The EPA ``Integrated Science Assessment for Lead'' (USEPA, 2013b);
and (2) the National Toxicity Program's Monograph on Health Effects of
Low-level Lead (USHHS, 2012).
    A wealth of information exists on the adverse health effects
associated with lead exposure. When ingested, lead is distributed
throughout the body and can affect many organ systems. Lead is a highly
toxic contaminant that can cause adverse neurological, cardiovascular,
renal, reproductive, developmental, immunological and carcinogenic
effects. The neurological effects are particularly pronounced in
children; however, recent studies in the public health literature have
found that a wide spectrum of adverse health outcomes can occur in
people of all ages. In 2013, the U.S. Burden of Diseases Collaborators
identified lead as one of the top 15 mortality risk factors (and top 10
cardiovascular risk factors) in the country. In addition, a level of
lead exposure below which adverse effects do not occur has not been
identified. This suggests that further declines in lead exposure below
current-day levels could still yield meaningful benefits in the U.S.
population, and the reduction in lead exposures from this proposed rule
would result in fewer adverse health outcomes and, in turn, decrease
societal costs of treatment. Chapter 5 of the Technical Support
Document (USEPA, 2016) for this proposed rule contains additional
detailed information on the potential health impacts of lead on both
children and adults.

VIII. Statutory and Executive Orders Reviews

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

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this proposed rule have
been submitted for approval to the Office of Management and Budget
(OMB) under the PRA. The Information Collection Request (ICR) document
that EPA prepared has been assigned EPA ICR No. 2563.01. You can find a
copy of the ICR in the docket for this rule, and it is briefly
summarized here.
    The PRA requires EPA to estimate the burden on manufacturers and
primacy agencies of complying with the proposed rule. The information
collected as a result of this proposed rule should allow EPA to
determine appropriate requirements for specific manufacturers and
evaluate compliance with the proposed rule. For the first three years
after publication of the final rule in the Federal Register,
manufacturers will incur burden to conduct the following rule
compliance activities:
     Obtaining certification of products from an accredited
third party certification body to document compliance with the lead
free requirements as set forth in the SDWA.
     Maintaining record costs associated with the initial
certification (conducted by an accredited third party certification
body) that potable use products meet the requirements of NSF/ANSI
Standard 372.
     Preparing the initial certificate of conformity and
maintaining records for potable use products that are self-certified by
the manufacturer as being lead free.
    Respondents/affected entities: The respondents include
manufacturers of plumbing products intended for potable use and
manufacturers of some plumbing products eligible for the ``used
exclusively'' exemption that are physically compatible with potable use
products. States and local governments are not impacted by the rule.
For the first three years after publication of the

final rule, EPA is not anticipated to incur any reporting or
recordkeeping burden for implementation activities and ensuring
compliance.
    Respondent's obligation to respond: Compliance with the final
rulemaking regulatory requirements would be mandatory. The authority
for these requirements comes from EPA's authority for this proposed
rule is section 1450 of the SDWA, 42 U.S.C. 300j-9. It authorizes the
EPA Administrator to ``prescribe such regulations as are necessary or
appropriate to carry out his/her functions under this subchapter.''
    Estimated number of respondents: EPA estimates that 2,193 firms
will be affected by the proposed requirements of this regulation.
    Frequency of response: The requirements of this proposed rule that
occur once during the three year ICR period include: Obtaining initial
third-party certification or self-certify activities to indicate that a
product meets the lead free requirements. Ongoing costs include the
third party annual renewal fees, and for all firms annual recordkeeping
costs for third party or self-certification. The rule requirement to
respond to EPA requests for information is on an ad hoc basis (however,
this information collection is not anticipated to occur during the
three-year period covered by this ICR).
    Total estimated burden: Total three-year burden to manufacturers is
estimated to be 162,582 to 318,276 hours, therefore the average annual
burden number ranges from 54,194 to 106,092 hours. EPA estimated a
range of burden (and costs) based on a lower and upper bound estimate
of manufacturers that already include product and/or package lead free
messaging that comply with the proposed rule requirements, as well as
manufacturers that currently use a third party certifying agency.
Burden is defined at 5 CFR 1320.3(b).
    Total estimated cost: The total costs over the three-year period
are between $8.5 and $12.9 million, or an average of $2.8 to $4.3
million per year.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.
    Submit your comments on EPA's need for this information, the
accuracy of the provided burden estimates and any suggested methods for
minimizing respondent burden to EPA using the docket identified at the
beginning of this rule. You may also send your ICR-related comments to
OMB's Office of Information and Regulatory Affairs via email to
<EMAIL_ADDRESS>Attention: Desk Officer for the EPA. Since
OMB is required to make a decision concerning the ICR between 30 and 60
days after receipt, OMB must receive comments no later than February
16, 2017. EPA will respond to any ICR-related comments in the final
rule.

C. Regulatory Flexibility Act (RFA)

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

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

    EPA has determined that 1,976 plumbing product manufacturers out of
2,193 plumbing product manufacturers potentially subject to this
proposal meet the small business definitions. EPA's analysis of
projected impacts on small entities is described in detail in section
VII (Economic Impacts). EPA projects less than 2 percent of the 1,976
affected small entities may experience an impact of costs exceeding 1
percent of revenue and no small entities would incur compliance costs
exceeding 3 percent of revenue. Details of this analysis are presented
in Chapter 6 of the Technical Support Document, available in the
docket, for the proposed rule.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The proposed rule
places no federal mandates on state, local, or tribal governments. The
mandated annual cost to the private sector is estimated to be between
$11.8 and $18.3 million and the highest single year nominal cost is
$53.4 million which is below the $100 million UMRA threshold.

E. Executive Order 13132: Federalism

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

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

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

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

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it implements specific standards
established by Congress in statute. While the executive order does not
apply, EPA does anticipate that the labeling requirements associated
with

this proposal will limit the inadvertent use of leaded plumbing
products, thereby reducing exposure of children to lead in drinking
water.

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

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

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

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

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

IX. References

USHHS, 2012. National Toxicity Program Monograph on Health Effects
of Low-level Lead. U.S. Department of Health and Human Services.
June 2012. Available on the Internet at: https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf.
USEPA, 2013a. Summary of the Reduction of Lead in Drinking Water Act
and Frequently Asked Questions. December 2013. Available on the
Internet at: https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=P100M5DB.txt.
USEPA, 2013b. Final Report: Integrated Science Assessment for Lead.
EPA 600-R-10-075F. June 2013. Available on the Internet at: https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=255721.
USEPA, 2016. Technical Support Document for the Proposed Rule: Use
of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking
Water. EPA 815-R-16-009. December 2016.

List of Subjects

40 CFR Part 141

    Environmental protection, Chemicals, Indian--lands,
Intergovernmental relations, Radiation protection, Reporting and
recordkeeping requirements, Water supply.

40 CFR Part 143

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

    Dated: January 4, 2017.
Gina McCarthy,
Administrator.

    For the reasons set forth in the preamble, EPA proposes to amend
title 40 chapter I of the Code of Federal Regulations parts 141 and 143
as follows:

PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS

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

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

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

Subpart E--Special Regulations, Including Monitoring

Sec.  141.43   [Removed]

0
3. Remove Sec.  141.43.

PART 143--NATIONAL SECONDARY DRINKING WATER REGULATIONS

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

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

0
5. Revise the part heading for part 143 to read as follows:

PART 143--OTHER SAFE DRINKING WATER ACT REGULATIONS

0
6. Add subpart A to read as follows:

Subpart A--National Secondary Drinking Water Regulations

0
7. Redesignate Sec. Sec.  143.1 through 143.4 as subpart A.

Sec. Sec.  143.5-143.10   [Reserved]

0
8. Reserve Sec. Sec.  143.5 through 143.10.
0
9. Add subpart B to read as follows:
Subpart B--Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux
for Drinking Water
Sec.
143.11 Definitions.
143.12 Definition of lead free and calculation methodology.
143.13 Use prohibitions.
143.14 State enforcement of use prohibitions.
143.15 Introduction into commerce prohibitions.
143.16 Exempt uses and labeling of certain exempt use products.
143.17 Required labeling of products that must meet lead free
requirements.
143.18 Required labeling of solder and flux that is not lead free.
143.19 Required certification of products.
143.20 Compliance provisions.

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

Sec.  143.11   Definitions.

    The following definitions apply to this subpart:
    Accredited third party certification body means those bodies that
are accredited by the American National Standards Institute (ANSI) to
provide product certification to meet the lead free requirements of not
more than a weighted average of 0.25 percent lead content when used
with respect to the wetted surfaces, consistent with section 1417 of
the Safe Drinking Water Act and Sec.  143.12, such as certification to
the NSF/ANSI 372 standard.
    Administrator means the Administrator of the U.S. Environmental
Protection Agency or his or her authorized representative.
    Affiliated means a person or entity that directly or indirectly
through one or more intermediaries, controls or is controlled by, or is
under common control with, the person or entity specified. Affiliated
persons or entities include, but are not limited to: A parent company
and all wholly or partially owned subsidiaries of a parent company, or
two or more corporations or family partnerships that have overlap in
ownership or control.
    Alloy means a substance composed of two or more metals or of a
metal and a nonmetal.
    Coating means a thin layer of material such as paint, epoxy, zinc
galvanization, or other material usually applied by spraying or in
liquid form to coat internal surfaces of pipes, fittings or fixtures.
    Drinking water cooler means any mechanical device affixed to
drinking water supply plumbing which actively cools water for human
consumption.

    Fitting means a pipe fitting or plumbing fitting.
    Fixture means a receptacle or device that is connected to a water
supply system or discharges to a drainage system or both. Fixtures used
for potable uses shall include, but are not limited to: (1) Drinking
water coolers, drinking water fountains, drinking water bottle fillers,
dishwashers; (2) plumbed in devices such as point-of-use water
treatment devices, coffee makers, and refrigerator ice and water
dispensers; and (3) water heaters, water pumps, and water tanks, unless
such fixtures are not used for potable uses.
    Flux means a substance used for helping to melt or join metals such
as by removal of oxides and other coatings or residues from the metals
before joining by using solder or other means.
    Importer means any person who introduces into commerce any pipe,
any pipe or plumbing fitting or fixture, or any solder or flux that is
manufactured by a firm located outside of the United States.
    Introduce into commerce or introduction into commerce means the
sale or distribution of products, or offering products for sale or
distribution in the United States.
    Liner means a rigid lining such as a plastic or copper sleeve that
is: (1) Sealed with a permanent barrier to exclude lead-bearing
surfaces from water contact; and (2) of sufficient thickness and having
physical properties necessary to prevent erosion and cracking for the
expected useful life of the product.
    Manufacturer means a person or entity who: (1) Processes or makes a
product; or (2) has products processed or made under a contractual
arrangement for distribution using their brand name or trademark.
    Nonpotable services means all uses of water that are not potable
uses.
    Person means an individual; corporation; company; association;
partnership; municipality; or state, federal, or tribal agency
(including officers, employees, and agents of any corporation, company,
association, municipality, state, tribal, or federal agency).
    Pipe means a conduit or conductor, tubing or hose.
    Pipe fitting means any piece (such as a coupling, elbow, washer, or
gasket) used for connecting pipe lengths together or to connect other
plumbing pieces together or to change direction.
    Plumbing fitting means a plumbing component that controls the
volume and/or directional flow of water, such as kitchen faucets,
bathroom lavatory faucets, and valves.
    Potable uses means services or applications that provide water for
human ingestion such as for drinking, cooking, food preparation,
dishwashing, teeth brushing, or maintaining oral hygiene.
    Product means a pipe, fitting, fixture.
    Solder means a type of metal that is used to join metal parts such
as sections of pipe, without melting the existing metal in the parts to
be joined. Solder is usually sold or distributed in the form of wire
rolls or bars.
    United States includes its commonwealths, districts, states,
tribes, and territories.
    Water distribution main means a pipe, typically found under or
adjacent to a roadway that supplies water to buildings via service
lines.

Sec.  143.12   Definition of lead free and calculation methodology.

    (a) ``Lead free'' for the purposes of this subpart means:
    (1) Not containing more than 0.2 percent lead when used with
respect to solder and flux; and
    (2) Not more than a weighted average of 0.25 percent lead when used
with respect to the wetted surfaces of pipes, pipe fittings, plumbing
fittings, and fixtures.
    (b) The weighted average lead content of a pipe, pipe fitting,
plumbing fitting, or fixture is calculated by using the following
formula: For each wetted component, the percentage of lead in the
component is multiplied by the ratio of the wetted surface area of that
component to the total wetted surface area of the entire product to
arrive at the weighted percentage of lead of the component. The
weighted percentage of lead of each wetted component is added together,