Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking Water, 4805-4825 [2017-00743]
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Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
the nature of the preventive control and
its role in the facility’s food safety
system, the facility must conduct
activities that include environmental
monitoring, for an environmental
pathogen or for an appropriate indicator
organism, if contamination of an RTE
food with an environmental pathogen is
a hazard requiring a preventive control,
by collecting and testing environmental
samples (§ 117.165(a)(3)). The revised
draft guidance includes
recommendations for controls to
significantly minimize or prevent L.
monocytogenes in RTE foods, for
sanitation controls to eliminate L.
monocytogenes from the food
production environment, and for
environmental monitoring as
verification of sanitation controls.
II. Paperwork Reduction Act of 1995
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The revised draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501–3520). The
collections of information in part 117
have been approved under OMB Control
No. 0910–0751.
FDA tentatively concludes that the
revised draft guidance also contains
proposed information collection
provisions that are subject to review by
OMB under the PRA but are not
included in the information collection
approved under OMB Control No. 0910–
0751. ‘‘Collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, we will publish a 60-day
notice on the proposed collection of
information in a future issue of the
Federal Register.
III. Electronic Access
Persons with access to the Internet
may obtain the revised draft guidance at
either https://www.fda.gov/
FoodGuidances or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
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IV. References
The following references are on
display at the Division of Dockets
Management (see ADDRESSES) and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also
available electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. FDA. 2015. Food Advisory Committee
Meeting, Charge and Questions. Topic:
Addressing Listeria monocytogenes in
Ready-To-Eat Foods, December 7–8,
2015. Available at https://www.fda.gov/
downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/
FoodAdvisoryCommittee/
UCM472842.pdf.
2. FDA. 2015. Food Advisory Committee
(FAC) Recommendations. Topic:
Addressing Listeria monocytogenes in
Ready-To-Eat Foods, December 7–8,
2015. Available at https://www.fda.gov/
downloads/AdvisoryCommittees/
CommitteesMeetingMaterials/
FoodAdvisoryCommittee/
UCM476521.pdf.
Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00819 Filed 1–13–17; 8:45 am]
BILLING CODE 4164–01–P
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
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
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
SUMMARY:
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4805
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: https://
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
https://www2.epa.gov/dockets/
commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT: Russ
Perkinson, telephone number: 202–564–
4901; email address: perkinson.russ@
epa.gov, Office of Ground Water and
Drinking Water, Standards and Risk
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Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
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
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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
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would introduce plumbing products
into commerce, such as manufacturers,
importers, wholesalers, distributors, resellers, 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
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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
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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.
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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
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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,
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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
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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
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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
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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
§ 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
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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.
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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 reintroduced 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
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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 § 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.
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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 nonpotable 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).
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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
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party certification body or by selfcertification 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 selfcertification 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
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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 selfcertification 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:
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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 selfcertification 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 selfcertification?
7. Is the definition of importer in
§ 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,
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4811
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 § 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
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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
Units produced
annually
(2013)
NAICS for
product
Number of
manufacturers
for product
Product category
Product name
Pipe and Fittings .................
Copper Tube (<4″ in diameter) ......................................
PEX Pipe (<4″ in diameter) ............................................
CPVC Pipe (<4″ in diameter) .........................................
Copper Fittings (<4″ in diameter) ...................................
Brass Fittings (<4″ in diameter) .....................................
PEX Fittings (<4″ in diameter) .......................................
CPVC Pipe Fittings (<4″ in diameter) ............................
Small and Mid-Diameter PVC Pipe ................................
PVC Pipe Fittings ...........................................................
Kitchen and Bar Faucet Market .....................................
Lavatory Faucet ..............................................................
Kitchen Sink ...................................................................
233,049,645
348,583,587
148,219,048
93,219,858
80,026,241
99,620,061
59,287,619
58,257,345
14,927,862
8,531,915
18,635,258
4,730,496
332996
326122
326122
332913
332913
332913
332913
326122
332913
332913
332913
332999
213
27
48
119
523
47
63
143
103
74
74
24
Sink Strainer ...................................................................
Point-of-entry Residential Water Filtration Market .........
11,036,332
1,236,699
332999
333318
24
713
Point-of-use Counter Top Water Filtration Market .........
Point-of-use Under the Sink Water Filtration Market .....
Point-of-use Faucet Mount Water Filtration Market .......
Stop Valve Market ..........................................................
.........................................................................................
72,857
261,702
1,707,194
9,455,319
............................
333318
333318
333318
332911
............................
694
704
694
23
............................
Stainless Steel Braided Hose Market ............................
Residential Inline Valve Market ......................................
Combi Boiler Market .......................................................
Residential Gas Tankless Water Heater Market ...........
Residential Gas Storage Water Heaters ........................
Residential Electric Storage Water Heaters ..................
Residential Indirect Fired Water Heater Market ............
Residential Electric Tankless Water Heater Market ......
Residential Solar Storage Water Heater Market ...........
Residential Oil Water Heaters ........................................
Commercial Gas Storage Water Heater Market ............
Commercial Electric Storage Water Heater Market .......
Water Cooler/Drinking Fountain/Bubbler Market ...........
9,424,559
30,597,771
55,527
410,831
4,338,506
4,061,277
133,647
276,398
21,819
31,692
89,706
70,071
557,244
333999
332919
333999
335228
335228
335228
335228
335228
335228
335228
335228
335228
333415
204
204
15
20
11
11
10
19
42
1
11
15
5
Refrigerators with Water Dispenser/Ice Making Machinery.
Dishwasher Market .........................................................
Water Softener Market ...................................................
Coffee Makers ................................................................
4,540,527
335222
7
5,537,416
3,444,782
234,247
335228
333318
333318
5
98
40
Aerator ............................................................................
Backflow preventers/Vacuum Breakers .........................
Gaskets/O-rings ..............................................................
Pumps ............................................................................
Water Meters/End Point Meters .....................................
27,167,173
32,202
5,433,435
1,808,369
7,053,100
332913
332913
339991
333911
334514
3
11
13
19
68
Faucets and Mixers ............
Kitchen Sinks and Accessories.
Residential Water Filtration
Products.
Stop Valves, Stainless Steel
Braided Hoses, Inline
Valves.
Water Heaters and Boilers
Water Coolers/Drinking
Fountains/Bubblers.
Household Appliances ........
Household & Commercial
Appliances.
Other ...................................
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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
Units produced
annually
(2013)
Product category
Product name
Pipe and Fittings .................
Pipe and Fittings Faucets
and Mixers.
Copper Tube (<4″ in diameter) ......................................
PEX Pipe (<4″ in diameter) ............................................
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NAICS for
product
81,033,435
59,116,515
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326122
Number of
manufacturers
for product
213
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TABLE V.2—PRODUCT SUBCATEGORIES, PRODUCTION, NAICS AND NUMBER OF MANUFACTURERS EPA IDENTIFIED FOR
PRODUCTS ELIGIBLE FOR THE ‘‘USED EXCLUSIVELY’’ EXEMPTION—Continued
Product category
Units produced
annually
(2013)
Product name
Stop Valves, Stainless Steel
Braided Hoses, Inline
Valves.
Stop Valves, Stainless Steel
Braided Hoses, Inline
Valves, Other.
Other ...................................
NAICS for
product
Number of
manufacturers
for product
CPVC Pipe (<4″ in diameter) .........................................
Copper Fittings (<4″ in diameter) ...................................
Brass Fittings (<4″ in diameter) .....................................
PEX Fittings (<4″ in diameter) .......................................
CPVC Pipe Fittings (<4″ in diameter) ............................
Small and Mid-Diameter PVC Pipe ................................
PVC Pipe Fittings ...........................................................
Laundry Faucet ..............................................................
Stop Valve Market ..........................................................
39,876,190
32,413,374
27,825,836
16,894,630
15,950,476
68,389,058
35,048,024
1,122,594
62,175,887
326122
332913
332913
332913
332913
326122
332913
332913
332911
48
119
523
47
63
143
103
72
23
Stainless Steel Braided Hose Market ............................
Aerator ............................................................................
106,928,024
1,122,594
333999
332913
204
3
Backflow preventers/Vacuum Breakers .........................
Gaskets/O-rings ..............................................................
Pumps ............................................................................
79,265
224,519
21,914
332913
339991
333911
11
13
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
A ......................................
B ......................................
C .....................................
Option description
•
•
•
•
•
•
Product labels and package marking for potable use products.
Third party certification required for all firms.
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.
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
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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.
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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
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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 $0.14 million.
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TABLE V.4—RULE INITIAL ADMINISTRATIVE AND INITIAL IMPLEMENTATION ANNUALIZED COSTS, IN MILLIONS
[2014$]
Read and understand the rule
Messaging design change
Initial rule implementation cost
Discount rate
Discount rate
Discount rate
Manufacturer size (no. of employees)
3%
<100 .........................................................
100–499 ...................................................
≥500 .........................................................
All Sizes ...................................................
7%
$0.051
0.001
0.008
0.07
3%
$0.073
0.016
0.012
0.101
7%
$0.011–0.021
0.002–0.005
0.001–0.001
0.014–0.027
3%
$0.015–0.03
0.003–0.007
0.001–0.001
0.02–0.038
7%
$0.061–0.072
0.014–0.016
0.009–0.009
0.084–0.097
$0.088–0.103
0.020–0.023
0.013–0.013
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 existing messaging
but not lead-related
(incur partial messaging costs)
Percent with lead-content
messaging
Manufacturer size
(number of employees)
Product
<100 .........................................................
100–499 ...................................................
≥500 .........................................................
Package
75
75
90
Product
75
90
90
Package
20
20
5
Percent with no messaging
(incur total messaging costs)
Product
20
5
5
Package
5
5
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 existing messaging
but not lead-related
(incur partial messaging costs)
Percent with lead-content
messaging
Manufacturer size
(number of employees)
Product
<100 .........................................................
100–499 ...................................................
≥500 .........................................................
Package
50
50
90
Product
50
90
90
Package
45
45
5
Percent with no messaging
(incur total messaging costs)
Product
45
5
5
Package
5
5
5
5
5
5
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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
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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
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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
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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
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
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
in millions
(2014$)
Option
A: Product and package messaging .......................................................................................................
B: Product and package messaging .......................................................................................................
C: Product or package messaging ..........................................................................................................
7% Discount rate
in millions
(2014$)
$8.69–10.34
8.69–10.34
1.17–1.28
$11.32–13.60
11.32–13.60
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
messaging
sradovich on DSK3GMQ082PROD with PROPOSALS
Manufacturer size
(number of employees)
Product
(%)
<100 .........................................................
100–499 ...................................................
1 Small products like gaskets and o-rings are
assumed to be bagged with lead free messaging.
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Percent with existing messaging
but not lead-related
(incur partial messaging costs)
Package
(%)
50
75
Product
(%)
50
75
Product
(%)
Package
(%)
45
20
45
20
2 Products that are not sold with packaging like
pipe are assumed to comply by printing on product.
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Percent with no messaging
(incur total messaging costs)
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(%)
5
5
5
5
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TABLE V.8—ESTIMATED PERCENTAGE OF PRODUCTS ELIGIBLE FOR ‘‘USED EXCLUSIVELY’’ EXEMPTION WITH AND WITHOUT
EXISTING MESSAGING—Continued
[Lower bound]
Percent with lead-related
messaging
Manufacturer size
(number of employees)
Product
(%)
≥500 .........................................................
Percent with existing messaging
but not lead-related
(incur partial messaging costs)
Package
(%)
75
Product
(%)
75
Percent with no messaging
(incur total messaging costs)
Product
(%)
Package
(%)
20
20
Package
(%)
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
messaging
Manufacturer size
(number of employees)
Product
(%)
<100 .........................................................
100–499 ...................................................
≥500 .........................................................
Percent with existing messaging
but not lead-related
(incur partial messaging costs)
Package
(%)
25
50
50
Product
(%)
25
50
50
Percent with no messaging
(incur total messaging costs)
Product
(%)
Package
(%)
70
45
45
70
45
45
Package
(%)
5
5
5
5
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.
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
in millions
(2014$)
Manufacturer size
(number of employees)
7% Discount rate
in millions
(2014$)
<100 .........................................................................................................................................................
100–499 ...................................................................................................................................................
≥500 .........................................................................................................................................................
$0.03–$0.03
0.01–0.01
0.11–0.17
$0.02–$0.03
0.01–0.01
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.
sradovich on DSK3GMQ082PROD with PROPOSALS
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
3 Small products like gaskets and o-rings are
assumed to be bagged with lead free messaging.
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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,
4817
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
certifying bodies and to which
certification costs would apply
Manufacturer size
(number of employees)
Lower
bound (%)
<100 .........................................................................................................................................................
100–499 ...................................................................................................................................................
≥500 .........................................................................................................................................................
Upper
bound (%)
25
10
10
50
10
10
Source: Technical Support Document, Exhibit 4–18 (USEPA, 2016).
sradovich on DSK3GMQ082PROD with PROPOSALS
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
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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 recertification annually. The other four
certification bodies require renewal on a
less frequent basis, the longest being
every five years. EPA determined a fiveyear 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
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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 $2.98 million
reported here are for all firms
conducting self-certifications. EPA did
not assess any cost savings to firms that
would no longer choose to have
products third party certified.
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TABLE V.12—TOTAL ANNUALIZED PRESENT VALUE COSTS FOR DEMONSTRATION OF COMPLIANCE REQUIREMENTS,
MILLIONS
[2014$]
3% Discount rate
in millions
(2014$)
Option
A: Third party certification only ................................................................................................................
B: Third party for ≥100; Choice of self-certification for <100 (Proposed Rule) ......................................
C: Third party certification or self-certification .........................................................................................
$11.20–$20.90
2.82–4.14
1.52–2.84
7% Discount rate
in millions
(2014$)
$11.56–$21.58
2.93–4.31
1.59–2.98
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
<100 .........................................................................................................................................................
100–499 ...................................................................................................................................................
≥500 .........................................................................................................................................................
All Sizes ...................................................................................................................................................
$0.0012
0.0025
0.0087
0.0124
7% Discount rate
$0.0012
0.0024
0.0083
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.
sradovich on DSK3GMQ082PROD with PROPOSALS
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 noncompliance 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
A: Label product and packaging/third party certification .........................................................................
B: (Proposed Rule): Label product and packaging/third party certification for manufacturers ≥100 employees and third party or self-certification for others .........................................................................
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7% Discount rate
$20.1–$31.6
$23.1–$35.5
11.8–14.8
14.5–18.3
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TABLE VI.1—TOTAL ANNUALIZED SOCIAL COSTS—Continued
[Millions, 2014$]
Regulatory option 1
3% Discount rate
C: Label product or packaging/third party or self-certification ................................................................
2.9–4.5
7% Discount rate
3.0–4.6
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
sradovich on DSK3GMQ082PROD with PROPOSALS
To provide an assessment of the
impact of the rule on plumbing
manufacturing firms, EPA used a costto-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-torevenue 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
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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
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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-torevenue 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.
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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)
Option description 1
Option
Count 2
Total
A ........
B ........
C ........
Product and Package Costs for Potable Product
or Package Costs for ‘‘Used Exclusively’’ Exempt Product, 3rd Party Cert for all manufacturers.
Product and 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.
Product or Package Costs for Potable Product or
Package Costs for ‘‘Used Exclusively’’ Exempt
Product, Self or 3rd Party Cert for all manufacturers.
≥1%
Large entities
(3% discount rate)
Count 2
Percentage
≥3%
≥1%
≥3%
Total
≥1%
Percentage
≥3%
≥1%
≥3%
1,976
783
27
40
1
217
1
0
0.5
0.0
1,976
29
0
2
0
217
1
0
0.5
0.0
1,976
0
0
0.0
0.0
217
0
0
0.0
0.0
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.
sradovich on DSK3GMQ082PROD with PROPOSALS
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
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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.
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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 selfcertified 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
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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 thirdparty 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 threeyear 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 ICRrelated comments to OMB’s Office of
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Information and Regulatory Affairs via
email to OIRA_submission@
omb.eop.gov, 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
standard
NAICS code
326122
332911
332913
332919
332996
332999
333318
333415
333911
333999
334514
335222
335228
339991
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
750
750
1000
750
500
750
1000
1250
750
500
750
1250
1000
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
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4821
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
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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.
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:
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
PART 141—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
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.
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.
1. The authority citation for part 141
continues to read as follows:
■
sradovich on DSK3GMQ082PROD with PROPOSALS
§ 141.43
■
[Removed]
3. Remove § 141.43.
PART 143—NATIONAL SECONDARY
DRINKING WATER REGULATIONS
4. The authority citation for part 143
continues to read as follows:
■
Authority: 42 U.S.C. 300f et seq.
5. Revise the part heading for part 143
to read as follows:
USHHS, 2012. National Toxicity Program
Monograph on Health Effects of Lowlevel 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.
17:33 Jan 13, 2017
Subpart E—Special Regulations,
Including Monitoring
■
IX. References
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2. Revise the subpart heading for
subpart E to read as follows:
■
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PART 143—OTHER SAFE DRINKING
WATER ACT REGULATIONS
■
6. Add subpart A to read as follows:
Subpart A—National Secondary
Drinking Water Regulations
7. Redesignate §§ 143.1 through 143.4
as subpart A.
■
§§ 143.5–143.10
■
[Reserved]
8. Reserve §§ 143.5 through 143.10.
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■
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
§ 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
§ 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.
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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.
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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.
§ 143.12 Definition of lead free and
calculation methodology.
(a) ‘‘Lead free’’ for the purposes of this
subpart means:
(1) Not containing more than 0.2
percent lead when used with respect to
solder and flux; and
(2) Not more than a weighted average
of 0.25 percent lead when used with
respect to the wetted surfaces of pipes,
pipe fittings, plumbing fittings, and
fixtures.
(b) The weighted average lead content
of a pipe, pipe fitting, plumbing fitting,
or fixture is calculated by using the
following formula: For each wetted
component, the percentage of lead in
the component is multiplied by the ratio
of the wetted surface area of that
component to the total wetted surface
area of the entire product to arrive at the
weighted percentage of lead of the
component. The weighted percentage of
lead of each wetted component is added
together, and the sum of these weighted
percentages constitutes the weighted
average lead content of the product. The
lead content of the material used to
produce wetted components is used to
determine compliance with paragraph
(a)(2) of this section. For lead content of
materials that are provided as a range,
the maximum content of the range must
be used.
(c) If a coating, as defined in § 143.11,
is applied to the internal surfaces of a
pipe, fitting or fixture component, the
maximum lead content of both the
coating and the alloy must be used to
calculate the lead content of the
component.
(d) If a liner, as defined in § 143.11,
is manufactured into a pipe, fitting or
fixture, the maximum lead content of
the liner must be used to calculate the
lead content of the component.
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§ 143.13
4823
Use prohibitions.
(a) No person may use any pipe, any
pipe or plumbing fitting or fixture, any
solder or any flux that is not lead free
as defined in § 143.12 in the installation
or repair of:
(1) Any public water system; or
(2) Any plumbing in a residential or
nonresidential facility providing water
for human consumption.
(b) Paragraph (a) of this section shall
not apply to leaded joints necessary for
the repair of cast iron pipes.
§ 143.14 State enforcement of use
prohibitions.
As a condition of receiving a full
allotment of Public Water System
Supervision grants under section
1443(a) of the Safe Drinking Water Act,
states must enforce the requirements of
section 1417(a)(1) of Safe Drinking
Water Act and § 143.13 through state or
local plumbing codes, or such other
means of enforcement as the state may
determine to be appropriate.
§ 143.15 Introduction into commerce
prohibitions.
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 in
the United States, except manufacturers,
to sell solder or flux that is not lead free;
and
(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.
§ 143.16 Exempt uses and labeling of
certain exempt use products.
The prohibitions in §§ 143.13 and
143.15 shall not apply to the products
listed in paragraphs (a) through (c) of
this section:
(a) Pipes, pipe fittings, plumbing
fittings, or fixtures, including backflow
preventers, that are used exclusively for
nonpotable services such as
manufacturing, industrial processing,
irrigation, outdoor watering, or any
other uses where the water is not
anticipated to be used for human
consumption. For the purposes of this
subpart, ‘‘used exclusively for
nonpotable services’’ means:
(1) The product is incapable of use in
potable services (e.g., physically
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Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
incompatible with other products that
would be needed to convey water for
potable uses); or
(2) The product is clearly labeled, on
the product, package, container, or tag
with a phrase such as: ‘‘Not for use with
water for human consumption’’ or
another phrase that conveys the same
meaning in plain language.
(b) Toilets, bidets, urinals, fill valves,
flushometer valves, tub fillers, shower
valves, fire hydrants, service saddles,
water distribution main gate valves that
are 2 inches in diameter or larger.
(c) Clothes washing machines, fire
suppression sprinklers, eyewash
devices, sump pumps, and emergency
drench showers.
sradovich on DSK3GMQ082PROD with PROPOSALS
§ 143.17 Required labeling of products
that must meet lead free requirements.
(a) Persons that introduce into
commerce products that must meet the
lead free requirements of section
1417(a)(3)(A) of the Safe Drinking Water
Act and § 143.12 must label such
products to indicate that it is in
compliance with those requirements.
Such labeling must occur by [DATE 3
YEARS AFTER PUBLICATION OF
FINAL RULE IN THE Federal Register]
or prior to introduction into commerce,
whichever occurs later.
(b) Labeling or marking as specified in
paragraph (a) of this section must be in
accordance with paragraphs (b)(1),
(b)(2), and (c) of this section:
(1) Packaged, containerized or tagged
products must be labeled or marked on
the package, container, or tag with a
phrase such as: ‘‘Conforms with the lead
free requirements of the federal Safe
Drinking Water Act,’’ ‘‘Lead Free,’’ or
similar terms that clearly convey to
users that the product is in compliance
with the applicable requirements.
Products that are not packaged,
containerized or tagged are only
required to be marked consistent with
requirements in paragraph (b)(2) of this
section. Shrink wrapping of bulk
products solely for the purpose of
shipping or storage does not constitute
being packaged, containerized, or
tagged.
(2) Products must be directly marked
by physically stamping, forging, or
printing with indelible ink, except as
provided in (b)(2)(i) or (b)(2)(ii) of this
section. The marking must clearly
convey to consumers that the product is
lead free, such as ‘‘Lead Free,’’ ‘‘LF,’’ or
certification marks. If the marking is
‘‘LF’’ or another abbreviation, symbol or
acronym, the product package,
container, or tag must associate that
marking with a phrase such as ‘‘lead
free’’ or ‘‘meets lead free requirements.’’
Product markings should be located
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17:33 Jan 13, 2017
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where they are visible after product
installation when practical.
(i) If the product is too small for a
legible marking in a type face ranging
from approximately 8 point to 14 point
depending on the method of marking
and roughness of product surface, only
a product package, container or tag must
be labeled or marked.
(ii) If the visible marking on installed
products will adversely impact the
visual appeal to consumers of the
finished product, the product may be
marked in a location not visible after
installation.
(c) For products certified by
accredited third party certification
bodies, labeling or marking on the
product, package, container, tag or some
combination of these locations must
include:
(1) The logo or name of the
certification body as specified by the
specific certification body; and
(2) The specific certification body’s
required identifier text to convey lead
free or low lead content.
§ 143.18 Required labeling of solder and
flux that is not lead-free.
Solder and flux that is not ‘‘lead free’’
as defined in § 143.12(a)(1) must bear a
prominent label stating that it is illegal
to use the solder or flux in the
installation or repair of any plumbing
providing water for human
consumption.
§ 143.19 Required certification of
products.
(a) Manufacturers or importers that
introduce into commerce products that
must meet the lead free requirements of
section 1417 of the Safe Drinking Water
Act and § 143.12 must ensure that the
products are certified to be in
compliance as specified in paragraphs
(b) and (c) of this section by [DATE 3
YEARS AFTER PUBLICATION OF
FINAL RULE IN THE Federal Register]
or prior to product introduction into
commerce, whichever occurs later. Such
manufacturers or importers must
maintain documentation to substantiate
the certification.
(b) Certification of products must be
obtained by manufacturers or importers
from an accredited third party
certification body, except as provided in
paragraph (c) of this section.
(1) Products certified by an accredited
third party certification body must be
labeled or marked as specified in
§ 143.17(c).
(2) The manufacturer or importers
must keep records for all products
certified by an accredited third party
certification body that include at a
minimum: Documentation of
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Frm 00027
Fmt 4702
Sfmt 4702
certification, dates of certification and
expiration. This documentation must be
provided upon request to the
Administrator as specified in
§ 143.20(b).
(c) Manufacturers having fewer than
100 employees or importers sourcing
products from or representing
manufacturers having fewer than 100
employees may elect to self-certify
products in lieu of obtaining
certification from an accredited third
party certification body. The number of
employees includes any persons
employed by the manufacturer and any
of its affiliated entities. The number of
employees must be calculated by
averaging the number of persons
employed, regardless of part-time, fulltime or temporary status by an entity
and all of its affiliated entities for each
pay period over the entity’s latest 12
calendar months, or averaged over the
number of months in existence if less
than 12 months. Such manufacturers or
importers electing to self-certify
products must comply with paragraphs
(d) through (g) of this section.
(d) In order for eligible manufacturers
or importers to self-certify products,
such manufacturers or importers must
attest that products are in compliance
by developing and maintaining a
‘‘certificate of conformity.’’ The
certificate of conformity must be:
(1) Signed by a responsible corporate
officer, a general partner or proprietor,
or an authorized representative of a
responsible corporate officer, general
partner or proprietor; and
(2) Posted to a Web page with
continuing public access in the United
States.
(e) The certificate of conformity must
be in English and include:
(1) Contact information for the
manufacturer or importer to include:
(i) The entity or proprietor name,
(ii) Street and mailing addresses,
(iii) Phone number, and
(iv) Email address.
For products imported into the United
States, the contact information must
also be included for the manufacturer;
(2) A brief listing of the products to
include, when applicable, unique
identifying information such as model
names and numbers;
(3) A statement attesting that the
products meet the lead free
requirements of the Safe Drinking Water
Act and 40 CFR part 143, subpart B and
also that the manufacturer or importer is
eligible to self-certify the product
consistent with this regulation;
(4) A statement indicating how the
manufacturer or importer verified
conformance with the Safe Drinking
E:\FR\FM\17JAP1.SGM
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Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
Water Act and 40 CFR part 143, subpart
B; and
(5) The signature, date, name and
position of the signatory; and if the
signatory is an authorized representative
of a responsible corporate officer, a
general partner or proprietor, the name
and position of the responsible
corporate officer, a general partner or
proprietor.
(f) Manufacturers or importers that
self-certify products must maintain, at a
primary place of business within the
United States, certificates of conformity
and sufficient documentation to confirm
that products meet the lead free
requirements of this subpart. Sufficient
documentation may include: Detailed
schematic drawings of the products
indicating dimensions, calculations of
the weighted average lead content of the
product, lead content of materials used
in manufacture and other
documentation used in verifying the
lead content of a plumbing device. This
documentation and certificates of
conformity must be provided upon
request to the Administrator as specified
in § 143.20(b).
(g) The certificate of conformity and
documentation must be completed prior
to a product’s introduction into
commerce.
§ 143.20
Compliance provisions.
(a) Noncompliance with the Safe
Drinking Water Act or this subpart may
be subject to enforcement. Enforcement
actions may include seeking injunctive
relief, civil or criminal penalties.
(b) The Administrator may, on a caseby-case basis, request any information
deemed necessary to determine whether
a person has acted or is acting in
compliance with section 1417 of the
Safe Drinking Water Act and this
subpart. Such information requested
must be provided to the Administrator
at a time and in a format as may be
reasonably determined by the
Administrator.
[FR Doc. 2017–00743 Filed 1–13–17; 8:45 am]
BILLING CODE 6560–50–P
ACTION:
Proposed rule.
SUPPLEMENTARY INFORMATION:
As required under section
6(b)(1) of the Toxic Substances Control
Act (TSCA), EPA is proposing to
establish a risk-based screening process
and criteria that EPA will use to identify
chemical substances as either HighPriority Substances for risk evaluation,
or Low-Priority Substances for which
risk evaluations are not warranted at the
time. The proposed rule describes the
processes for identifying potential
candidates for prioritization, selecting a
candidate, screening that candidate
against certain criteria, formally
initiating the prioritization process,
providing opportunities for public
comment, and proposing and finalizing
designations of priority. Prioritization is
the initial step in a new process of
existing chemical substance review and
risk management activity established
under recent amendments to TSCA.
DATES: Comments must be received on
or before March 20, 2017.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2016–0636, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
ENVIRONMENTAL PROTECTION
AGENCY
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40 CFR Part 702
[EPA–HQ–OPPT–2016–0636; FRL–9957–74]
RIN 2070–AK23
Procedures for Prioritization of
Chemicals for Risk Evaluation Under
the Toxic Substances Control Act
Environmental Protection
Agency (EPA).
AGENCY:
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17:33 Jan 13, 2017
Jkt 241001
For technical information contact:
Ryan Schmit, Immediate Office, Office
of Chemical Safety and Pollution
Prevention, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–0610; email address:
schmit.ryan@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
PO 00000
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4825
I. Executive Summary
A. Does this action apply to me?
This proposed rule does not propose
to establish any requirements on
persons or entities outside of the
Agency. This action may, however, be of
interest to entities that are or may
manufacture or import a chemical
substance regulated under TSCA (e.g.,
entities identified under North
American Industrial Classification
System (NAICS) codes 325 and 324110).
Since other entities may also be
interested, the Agency has not
attempted to describe all the specific
entities and corresponding NAICS codes
for entities that may be interested in or
affected by this action.
B. What action is the agency taking?
EPA is proposing to establish the
internal processes and criteria by which
EPA will identify chemical substances
as either High-Priority Substances for
risk evaluation, or Low-Priority
Substances for which risk evaluations
are not warranted at the time.
C. Why is the agency taking this action?
This rulemaking is required by TSCA
section 6(b)(1)(A). Prioritization of
chemical substances for further
evaluation will ensure that the Agency’s
limited resources are conserved for
those chemical substances most likely to
present risks, thereby furthering EPA’s
overall mission to protect health and the
environment.
D. What is the agency’s authority for
taking this action?
EPA is proposing this rule pursuant to
the authority in TSCA section 6(b), 15
U.S.C. 2605(b). See also the discussion
in Units II.A and B.
E. What are the estimated incremental
impacts of this action?
This is a proposed rule that would
establish the processes by which EPA
intends to designate chemical
substances as either High or LowPriority Substances for risk evaluation.
It would not establish any requirements
on persons or entities outside of the
Agency. EPA did not, therefore, estimate
potential incremental impacts from this
action.
F. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
E:\FR\FM\17JAP1.SGM
17JAP1
]]>Agencies
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Proposed Rules]
[Pages 4805-4825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00743]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://www2.epa.gov/dockets/commenting-epa-dockets.
FOR FURTHER INFORMATION CONTACT: Russ Perkinson, telephone number:
202-564-4901; email address: perkinson.russ@epa.gov, Office of Ground
Water and Drinking Water, Standards and Risk
[[Page 4806]]
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
[[Page 4807]]
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
[[Page 4808]]
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
[[Page 4809]]
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.
[[Page 4810]]
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
[[Page 4811]]
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
[[Page 4812]]
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).
[[Page 4813]]
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 $0.14
million.
[[Page 4814]]
Table V.4--Rule Initial Administrative and Initial Implementation Annualized Costs, in Millions
[2014$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
[[Page 4815]]
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
[[Page 4816]]
>=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
[[Page 4817]]
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 $2.98 million reported here are for all firms conducting self-
certifications. EPA did not assess any cost savings to firms that would
no longer choose to have products third party certified.
[[Page 4818]]
Table V.12--Total Annualized Present Value Costs for Demonstration of
Compliance Requirements, Millions
[2014$]
------------------------------------------------------------------------
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.......
[[Page 4819]]
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.
[[Page 4820]]
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
[[Page 4821]]
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
OIRA_submission@omb.eop.gov, 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
[[Page 4822]]
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.
[[Page 4823]]
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,
and the sum of these weighted percentages constitutes the weighted
average lead content of the product. The lead content of the material
used to produce wetted components is used to determine compliance with
paragraph (a)(2) of this section. For lead content of materials that
are provided as a range, the maximum content of the range must be used.
(c) If a coating, as defined in Sec. 143.11, is applied to the
internal surfaces of a pipe, fitting or fixture component, the maximum
lead content of both the coating and the alloy must be used to
calculate the lead content of the component.
(d) If a liner, as defined in Sec. 143.11, is manufactured into a
pipe, fitting or fixture, the maximum lead content of the liner must be
used to calculate the lead content of the component.
Sec. 143.13 Use prohibitions.
(a) No person may use any pipe, any pipe or plumbing fitting or
fixture, any solder or any flux that is not lead free as defined in
Sec. 143.12 in the installation or repair of:
(1) Any public water system; or
(2) Any plumbing in a residential or nonresidential facility
providing water for human consumption.
(b) Paragraph (a) of this section shall not apply to leaded joints
necessary for the repair of cast iron pipes.
Sec. 143.14 State enforcement of use prohibitions.
As a condition of receiving a full allotment of Public Water System
Supervision grants under section 1443(a) of the Safe Drinking Water
Act, states must enforce the requirements of section 1417(a)(1) of Safe
Drinking Water Act and Sec. 143.13 through state or local plumbing
codes, or such other means of enforcement as the state may determine to
be appropriate.
Sec. 143.15 Introduction into commerce prohibitions.
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 in the United States, except manufacturers, to sell solder or
flux that is not lead free; and
(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.
Sec. 143.16 Exempt uses and labeling of certain exempt use products.
The prohibitions in Sec. Sec. 143.13 and 143.15 shall not apply to
the products listed in paragraphs (a) through (c) of this section:
(a) Pipes, pipe fittings, plumbing fittings, or fixtures, including
backflow preventers, that are used exclusively for nonpotable services
such as manufacturing, industrial processing, irrigation, outdoor
watering, or any other uses where the water is not anticipated to be
used for human consumption. For the purposes of this subpart, ``used
exclusively for nonpotable services'' means:
(1) The product is incapable of use in potable services (e.g.,
physically
[[Page 4824]]
incompatible with other products that would be needed to convey water
for potable uses); or
(2) The product is clearly labeled, on the product, package,
container, or tag with a phrase such as: ``Not for use with water for
human consumption'' or another phrase that conveys the same meaning in
plain language.
(b) Toilets, bidets, urinals, fill valves, flushometer valves, tub
fillers, shower valves, fire hydrants, service saddles, water
distribution main gate valves that are 2 inches in diameter or larger.
(c) Clothes washing machines, fire suppression sprinklers, eyewash
devices, sump pumps, and emergency drench showers.
Sec. 143.17 Required labeling of products that must meet lead free
requirements.
(a) Persons that introduce into commerce products that must meet
the lead free requirements of section 1417(a)(3)(A) of the Safe
Drinking Water Act and Sec. 143.12 must label such products to
indicate that it is in compliance with those requirements. Such
labeling must occur by [DATE 3 YEARS AFTER PUBLICATION OF FINAL RULE IN
THE Federal Register] or prior to introduction into commerce, whichever
occurs later.
(b) Labeling or marking as specified in paragraph (a) of this
section must be in accordance with paragraphs (b)(1), (b)(2), and (c)
of this section:
(1) Packaged, containerized or tagged products must be labeled or
marked on the package, container, or tag with a phrase such as:
``Conforms with the lead free requirements of the federal Safe Drinking
Water Act,'' ``Lead Free,'' or similar terms that clearly convey to
users that the product is in compliance with the applicable
requirements. Products that are not packaged, containerized or tagged
are only required to be marked consistent with requirements in
paragraph (b)(2) of this section. Shrink wrapping of bulk products
solely for the purpose of shipping or storage does not constitute being
packaged, containerized, or tagged.
(2) Products must be directly marked by physically stamping,
forging, or printing with indelible ink, except as provided in
(b)(2)(i) or (b)(2)(ii) of this section. The marking must clearly
convey to consumers that the product is lead free, such as ``Lead
Free,'' ``LF,'' or certification marks. If the marking is ``LF'' or
another abbreviation, symbol or acronym, the product package,
container, or tag must associate that marking with a phrase such as
``lead free'' or ``meets lead free requirements.'' Product markings
should be located where they are visible after product installation
when practical.
(i) If the product is too small for a legible marking in a type
face ranging from approximately 8 point to 14 point depending on the
method of marking and roughness of product surface, only a product
package, container or tag must be labeled or marked.
(ii) If the visible marking on installed products will adversely
impact the visual appeal to consumers of the finished product, the
product may be marked in a location not visible after installation.
(c) For products certified by accredited third party certification
bodies, labeling or marking on the product, package, container, tag or
some combination of these locations must include:
(1) The logo or name of the certification body as specified by the
specific certification body; and
(2) The specific certification body's required identifier text to
convey lead free or low lead content.
Sec. 143.18 Required labeling of solder and flux that is not lead-
free.
Solder and flux that is not ``lead free'' as defined in Sec.
143.12(a)(1) must bear a prominent label stating that it is illegal to
use the solder or flux in the installation or repair of any plumbing
providing water for human consumption.
Sec. 143.19 Required certification of products.
(a) Manufacturers or importers that introduce into commerce
products that must meet the lead free requirements of section 1417 of
the Safe Drinking Water Act and Sec. 143.12 must ensure that the
products are certified to be in compliance as specified in paragraphs
(b) and (c) of this section by [DATE 3 YEARS AFTER PUBLICATION OF FINAL
RULE IN THE Federal Register] or prior to product introduction into
commerce, whichever occurs later. Such manufacturers or importers must
maintain documentation to substantiate the certification.
(b) Certification of products must be obtained by manufacturers or
importers from an accredited third party certification body, except as
provided in paragraph (c) of this section.
(1) Products certified by an accredited third party certification
body must be labeled or marked as specified in Sec. 143.17(c).
(2) The manufacturer or importers must keep records for all
products certified by an accredited third party certification body that
include at a minimum: Documentation of certification, dates of
certification and expiration. This documentation must be provided upon
request to the Administrator as specified in Sec. 143.20(b).
(c) Manufacturers having fewer than 100 employees or importers
sourcing products from or representing manufacturers having fewer than
100 employees may elect to self-certify products in lieu of obtaining
certification from an accredited third party certification body. The
number of employees includes any persons employed by the manufacturer
and any of its affiliated entities. The number of employees must be
calculated by averaging the number of persons employed, regardless of
part-time, full-time or temporary status by an entity and all of its
affiliated entities for each pay period over the entity's latest 12
calendar months, or averaged over the number of months in existence if
less than 12 months. Such manufacturers or importers electing to self-
certify products must comply with paragraphs (d) through (g) of this
section.
(d) In order for eligible manufacturers or importers to self-
certify products, such manufacturers or importers must attest that
products are in compliance by developing and maintaining a
``certificate of conformity.'' The certificate of conformity must be:
(1) Signed by a responsible corporate officer, a general partner or
proprietor, or an authorized representative of a responsible corporate
officer, general partner or proprietor; and
(2) Posted to a Web page with continuing public access in the
United States.
(e) The certificate of conformity must be in English and include:
(1) Contact information for the manufacturer or importer to
include:
(i) The entity or proprietor name,
(ii) Street and mailing addresses,
(iii) Phone number, and
(iv) Email address.
For products imported into the United States, the contact
information must also be included for the manufacturer;
(2) A brief listing of the products to include, when applicable,
unique identifying information such as model names and numbers;
(3) A statement attesting that the products meet the lead free
requirements of the Safe Drinking Water Act and 40 CFR part 143,
subpart B and also that the manufacturer or importer is eligible to
self-certify the product consistent with this regulation;
(4) A statement indicating how the manufacturer or importer
verified conformance with the Safe Drinking
[[Page 4825]]
Water Act and 40 CFR part 143, subpart B; and
(5) The signature, date, name and position of the signatory; and if
the signatory is an authorized representative of a responsible
corporate officer, a general partner or proprietor, the name and
position of the responsible corporate officer, a general partner or
proprietor.
(f) Manufacturers or importers that self-certify products must
maintain, at a primary place of business within the United States,
certificates of conformity and sufficient documentation to confirm that
products meet the lead free requirements of this subpart. Sufficient
documentation may include: Detailed schematic drawings of the products
indicating dimensions, calculations of the weighted average lead
content of the product, lead content of materials used in manufacture
and other documentation used in verifying the lead content of a
plumbing device. This documentation and certificates of conformity must
be provided upon request to the Administrator as specified in Sec.
143.20(b).
(g) The certificate of conformity and documentation must be
completed prior to a product's introduction into commerce.
Sec. 143.20 Compliance provisions.
(a) Noncompliance with the Safe Drinking Water Act or this subpart
may be subject to enforcement. Enforcement actions may include seeking
injunctive relief, civil or criminal penalties.
(b) The Administrator may, on a case-by-case basis, request any
information deemed necessary to determine whether a person has acted or
is acting in compliance with section 1417 of the Safe Drinking Water
Act and this subpart. Such information requested must be provided to
the Administrator at a time and in a format as may be reasonably
determined by the Administrator.
[FR Doc. 2017-00743 Filed 1-13-17; 8:45 am]
BILLING CODE 6560-50-P
