Rule2024-25070
Reconsideration of the Dust-Lead Hazard Standards and Dust-Lead Post-Abatement Clearance Levels
Primary source
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Published
November 12, 2024
Effective
January 13, 2025
Issuing agencies
Environmental Protection Agency
Abstract
As part of EPA's high-priority efforts to reduce childhood lead exposure, and in accordance with a U.S. Court of Appeals for the Ninth Circuit 2021 opinion, EPA is finalizing its proposal to lower the dust-lead hazard standards to any reportable level as analyzed by a laboratory recognized by EPA's National Lead Laboratory Accreditation Program (NLLAP). EPA's lead-based paint (LBP) regulations do not compel property owners or occupants to evaluate their property for LBP hazards or to take control actions, but if a LBP activity such as an abatement is performed, then EPA's regulations set requirements for doing so. EPA is also finalizing changes to lower the post-abatement dust-lead clearance levels to 5 micrograms per square foot ([micro]g/ft\2\), 40 [micro]g/ft\2\, and 100 [micro]g/ft\2\ for floors, window sills and troughs respectively, the current levels in New York City. Due to feedback from public comments, EPA is also finalizing changes to the nomenclature to adopt the terms dust-lead reportable levels (DLRL) and dust-lead action levels (DLAL). Given the decoupling of the action levels from the reportable levels, EPA is finalizing revisions to the definition of abatement so that the recommendation for action based on dust-lead applies when dust-lead loadings are at or above the action levels, rather than the hazard standards, as has been the case historically. The dust-lead hazard standards will be described as DLRL moving forward (i.e., after publication of this final rule) and the dust-lead clearance levels will be described as DLAL. Additionally, EPA is finalizing several other amendments, including revising the definition of target housing to conform with the statute.
Full Text
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[Federal Register Volume 89, Number 218 (Tuesday, November 12, 2024)]
[Rules and Regulations]
[Pages 89416-89461]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-25070]
[[Page 89415]]
Vol. 89
Tuesday,
No. 218
November 12, 2024
Part IV
Environmental Protection Agency
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40 CFR Part 745
Reconsideration of the Dust-Lead Hazard Standards and Dust-Lead Post-
Abatement Clearance Levels; Final Rule
Federal Register / Vol. 89, No. 218 / Tuesday, November 12, 2024 /
Rules and Regulations
[[Page 89416]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 745
[EPA-HQ-OPPT-2023-0231; FRL-8524-02-OCSPP]
RIN 2070-AK91
Reconsideration of the Dust-Lead Hazard Standards and Dust-Lead
Post-Abatement Clearance Levels
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: As part of EPA's high-priority efforts to reduce childhood
lead exposure, and in accordance with a U.S. Court of Appeals for the
Ninth Circuit 2021 opinion, EPA is finalizing its proposal to lower the
dust-lead hazard standards to any reportable level as analyzed by a
laboratory recognized by EPA's National Lead Laboratory Accreditation
Program (NLLAP). EPA's lead-based paint (LBP) regulations do not compel
property owners or occupants to evaluate their property for LBP hazards
or to take control actions, but if a LBP activity such as an abatement
is performed, then EPA's regulations set requirements for doing so. EPA
is also finalizing changes to lower the post-abatement dust-lead
clearance levels to 5 micrograms per square foot ([micro]g/ft\2\), 40
[micro]g/ft\2\, and 100 [micro]g/ft\2\ for floors, window sills and
troughs respectively, the current levels in New York City. Due to
feedback from public comments, EPA is also finalizing changes to the
nomenclature to adopt the terms dust-lead reportable levels (DLRL) and
dust-lead action levels (DLAL). Given the decoupling of the action
levels from the reportable levels, EPA is finalizing revisions to the
definition of abatement so that the recommendation for action based on
dust-lead applies when dust-lead loadings are at or above the action
levels, rather than the hazard standards, as has been the case
historically. The dust-lead hazard standards will be described as DLRL
moving forward (i.e., after publication of this final rule) and the
dust-lead clearance levels will be described as DLAL. Additionally, EPA
is finalizing several other amendments, including revising the
definition of target housing to conform with the statute.
DATES: This final rule is effective January 13, 2025. The incorporation
by reference of certain material listed in this rule is approved by the
Director of the Federal Register as of January 13, 2025.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2023-0231, is available online
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For technical information: Claire Brisse, Existing Chemicals Risk
Management Division (7404M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 564-9004; email address:
<a href="/cdn-cgi/l/email-protection#f496869d878791da9798959d8691b4918495da939b82"><span class="__cf_email__" data-cfemail="aeccdcc7ddddcb80cdc2cfc7dccbeecbdecf80c9c1d8">[email protected]</span></a>.
For general information on lead: The National Lead Information
Center, 422 South Clinton Avenue, Rochester, NY 14620; telephone
number: (800) 424-LEAD [5323]; online form: <a href="https://www.epa.gov/lead/forms/lead-hotline-national-lead-information-center">https://www.epa.gov/lead/forms/lead-hotline-national-lead-information-center</a>.
For general information on TSCA: The TSCA Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#2e7a7d6d6f0366415a4247404b6e4b5e4f00494158"><span class="__cf_email__" data-cfemail="6a3e39292b4722051e0603040f2a0f1a0b440d051c">[email protected]</span></a>.
For hearing- or speech-impaired assistance: Persons may reach the
telephone numbers for the contacts through TTY by calling the toll-free
Federal Communications Commission's Telecommunications Relay Service at
711.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be affected by this action if you conduct LBP activities in
accordance with 40 CFR 745.227; if you operate a training program
required to be accredited under 40 CFR 745.225; if you are a firm or
individual who must be certified to conduct LBP activities or
renovations in accordance with 40 CFR 745.226; or if you own, manage,
and/or conduct abatement, rehabilitations or maintenance activities in
most pre-1978 housing that is covered by a Federal housing assistance
program in accordance with 24 CFR part 35. You may also be impacted by
this rule if you administer the LBP activities program in States,
territories, or Tribes that are authorized by EPA to operate their own
lead abatement programs (40 CFR part 745, subpart Q) (see Unit V.A. for
more information). You may also be affected by this action if you
operate a laboratory that is recognized by EPA's National Lead
Laboratory Accreditation Program in accordance with 40 CFR 745.90,
745.223, 745.227, and 745.327. You may also be affected by this action,
in accordance with 40 CFR 745.107 and 24 CFR 35.88, as the seller or
lessor of target housing, which is most pre-1978 housing. See 40 CFR
745.103 and 24 CFR 35.86. You may also be affected by this action if
you are a resident of target housing, even if you would not be subject
to the requirements of this action. Due to the change in the definition
of ``target housing,'' you may also be affected if you are a firm or
individual who must be certified to perform renovations in target
housing or child-occupied facilities (COFs) in accordance with 40 CFR
part 745, subpart E.
The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Affected entities may include:
<bullet> Building construction (NAICS code 236) (e.g., single-
family housing construction, multi-family housing construction,
residential remodelers).
<bullet> Specialty trade contractors (NAICS code 238) (e.g.,
plumbing, heating, and air-conditioning contractors, painting, and wall
covering contractors, electrical contractors, finish carpentry
contractors, drywall and insulation contractors, siding contractors,
tile and terrazzo contractors, glass, and glazing contractors).
<bullet> Real estate (NAICS code 531) (e.g., lessors of residential
buildings and dwellings, residential property managers, and property
owners, as well as those property owners that receive assistance
through Federal housing programs).
<bullet> Child day care services (NAICS code 624410).
<bullet> Elementary and secondary schools (NAICS code 611110)
(e.g., elementary schools with kindergarten classrooms).
<bullet> Other technical and trade schools (NAICS code 611519)
(e.g., training providers).
<bullet> Engineering services (NAICS code 541330) and building
inspection services (NAICS code 541350) (e.g., dust sampling
technicians).
<bullet> Lead abatement professionals (NAICS code 562910) (e.g.,
firms and supervisors engaged in LBP activities).
<bullet> Testing laboratories (NAICS code 541380) (e.g., those
laboratories that analyze dust wipe samples for lead).
<bullet> Federal agencies that own residential property (NAICS
codes 92511, 92811).
If you have questions regarding the applicability of this action to
a particular entity, consult the regulations
[[Page 89417]]
or contact the technical information person listed in the FOR FURTHER
INFORMATION CONTACT section.
B. What is the Agency's authority for taking this action?
EPA is finalizing this rule under the authority of sections 401,
402, 403, 404, and 406 of the Toxic Substances Control Act (TSCA), 15
U.S.C. 2601 et seq., as amended by Title X of the Housing and Community
Development Act of 1992 (also known as the Residential Lead-Based Paint
Hazard Reduction Act of 1992 or ``Title X'') (Pub. L. 102-550) (Ref. 1)
and section 237(c) of Title II of Division K of the Consolidated
Appropriations Act, 2017 (Pub. L. 115-31, 131 Stat. 789), as well as
sections 1004 and 1018 of Title X (42 U.S.C. 4851b, 4852d), as amended
by section 237(b) of Title II of Division K of the Consolidated
Appropriations Act, 2017.
TSCA section 403 (15 U.S.C. 2683) mandates EPA to identify LBP
hazards for purposes of administering Title X and TSCA Title IV. Under
TSCA section 401, LBP hazards are defined as conditions of LBP and
lead-contaminated dust and soil that ``would result in adverse human
health effects,'' (15 U.S.C. 2681(10)) and lead-contaminated dust is
defined as ``surface dust in residential dwellings'' that contains lead
in excess of levels determined ``to pose a threat of adverse health
effects . . .'' (15 U.S.C. 2681(11)). EPA has referred to the dust-lead
portion of the LBP hazards as the dust-lead hazard standards. As
explained in Unit IV.A. of this final rule, going forward EPA is also
describing these as the dust-lead reportable levels in order to better
connote their purpose under the revisions. In this document, EPA has
endeavored to use the term dust-lead hazard standards or DLHS to
describe the standards in place prior to this final rule and the term
dust-lead reportable levels or DLRL to describe the standards in place
going forward.
TSCA section 402 (15 U.S.C. 2682) directs EPA to regulate LBP
activities, which include risk assessments, inspections, and
abatements. TSCA section 401 (15 U.S.C. 2681) defines abatements as
``measures designed to permanently eliminate lead-based paint hazards''
and the term includes ``all . . . cleanup . . . and post[-]abatement
clearance testing activities'' (15 U.S.C. 2681(1)). EPA has referred to
the dust-lead level to be achieved after the post-abatement clearance
activities as the dust-lead clearance levels. As explained in Unit
IV.A. of this final rule, going forward EPA is also describing these as
the dust-lead action levels in order to better connote their purpose
under the revisions. In this document, EPA has endeavored to use the
term dust-lead clearance level or DLCL to describe the standards in
place prior to this final rule and the term dust-lead action levels or
DLAL to describe the standards in place going forward.
EPA's statutory authority for setting the hazard standards is laid
out differently in Title X and TSCA Title IV than its authority for
regulating clearance activities. In contrast to the grant of authority
for setting hazard standards, EPA is directed, in promulgating the LBP
activities regulations (including the DLAL), to ``tak[e] into account
reliability, effectiveness, and safety'' (15 U.S.C. 2682(a)(1)).
Pertaining to the other amendments presented in Unit IV.G. of this
preamble, TSCA section 406 (15 U.S.C. 2686) requires EPA, in
consultation with the Secretary of the U.S. Department of Housing and
Urban Development (HUD) and with the Secretary of the U.S. Department
of Health and Human Services (HHS) to ``publish, and from time to time
revise, a lead hazard information pamphlet to be used in connection
with this subchapter and section 4852d of title 42.'' TSCA section 406
(15 U.S.C. 2686) also requires EPA's regulations to require any person
performing for compensation a renovation of target housing to provide
the pamphlet to the owner and occupant prior to commencing the
renovation. Additionally, section 1018 of Title X (42 U.S.C. 4852d)
mandates that the Lead Warning Statement to be provided in contracts
for the purchase or sale of target housing include, among other
language, the following text: ``. . . The seller of any interest in
residential real property is required to provide the buyer with any
information on lead-based paint hazards from risk assessments or
inspections in the seller's possession and notify the buyer of any
known lead-based paint hazards.'' TSCA section 401 (15 U.S.C. 2681(17))
and section 1004 of Title X (42 U.S.C. 4851b), as amended by section
237(b) and (c) of Title II of Division K of the Consolidated
Appropriations Act, 2017 (Pub. L. 115-31, 131 Stat. 789), define target
housing as ``any housing constructed prior to 1978, except housing for
the elderly or persons with disabilities or any 0-bedroom dwelling
(unless any child who is less than 6 years of age resides or is
expected to reside in such housing) . . .'' In this context, ``housing
for the elderly'' refers to retirement communities or similar types of
housing reserved for households composed of one or more persons 62
years of age or more at the time of initial occupancy (40 CFR 745.103).
Note that HUD's Lead Safe Housing Rule (LSHR) caveats its definition of
``housing for the elderly'' at 24 CFR 35.110 to rely on an age other
than 62 years ``if recognized as elderly by a specific Federal housing
assistance program.''
C. What action is the Agency taking?
In 2019, EPA promulgated a final rule to lower the DLHS to 10
[mu]g/ft\2\ for floors and 100 [mu]g/ft\2\ for window sills (the 2019
Final Rule) (Ref. 2). In 2021, EPA promulgated a final rule to lower
the DLCL to 10 [mu]g/ft\2\ for floors and 100 [mu]g/ft\2\ for window
sills (the 2021 Final Rule) (Ref. 3). The 2019 Final Rule and the 2021
Final Rule continued a long-standing practice of setting the same
levels for the DLHS and the DLCL and basing those levels in part on
consideration of factors such as laboratory capacity and capabilities.
On August 1, 2023, EPA proposed revisions in keeping with an opinion
issued by the U.S. Court of Appeals for the Ninth Circuit (the Court)
in 2021 (described in Unit I.D.) that instructed EPA to consider only
health factors when setting the DLHS (described as DLRL moving forward)
and that EPA must continue to consider non-health factors (e.g.,
laboratory capabilities/capacity, and achievability after an abatement)
when setting the DLCL (described as DLAL moving forward). Note that due
to feedback from public comments, EPA is finalizing the previously
mentioned changes to the nomenclature, from DLHS to dust-lead
reportable level and from DLCL to dust-lead action level (see Unit
IV.A., for more discussion on this terminology change).
EPA is finalizing the proposed changes to the DLRL from 10 [mu]g/
ft\2\ for floors and 100 [mu]g/ft\2\ for window sills, as established
in the 2019 Final Rule, to any reportable level of dust-lead analyzed
by a NLLAP-recognized laboratory. The DLRL is not a static level set by
EPA but rather the numerically reportable level as analyzed by a NLLAP-
recognized laboratory. The approach represents a shift in the LBP
activities program to a more inclusive DLRL, which will identify dust-
lead hazards in the context of TSCA Title IV as any reportable level of
dust-lead in target housing and child-occupied facilities and will not
distinguish based on health risks posed. Additional discussion on DLRL
can be found in Unit IV.B.
Additionally, EPA is finalizing a reduction of 50% or more in the
values set by the 2021 Final Rule to the proposed alternative DLAL,
from 10 [mu]g/ft\2\ to 5 [mu]g/ft\2\ for dust-lead for floors,
[[Page 89418]]
from 100 [mu]g/ft\2\ to 40 [mu]g/ft\2\ dust-lead for window sills and
from 400 [mu]g/ft\2\ to 100 [mu]g/ft\2\ dust-lead for window troughs.
The reportable level for floors and window sills will not be the same
as the action level for floors and window sills (i.e., the standards
will be decoupled), acknowledging the different statutory direction
that Congress provided EPA with respect to each. As a result, EPA is
also finalizing the proposed amendment to the LBP activities
regulations' definition of abatement to be any measure or set of
measures designed to eliminate LBP hazards, in the case of dust-lead
hazards, to a level below the final DLAL; thus modifying the trigger so
that the recommendation for action applies when dust-lead loadings are
at or above the dust-lead action levels, rather than the hazard
standards (described as dust-lead reportable levels moving forward), as
has been the case historically. Note that EPA's LBP regulations do not
automatically compel property owners or occupants to evaluate their
property for LBP hazards or to take control actions, but if a LBP
activity such as an abatement is performed, then EPA's regulations set
requirements that must be met while doing so. EPA is also finalizing a
requirement to include an additional statement in the final abatement
reports that States that LBP hazards (particularly dust-lead hazards)
remain after an abatement if post-abatement testing has found that
reportable levels remain below the action levels. See Unit IV.E., and
Unit IV.F. for additional information on these programmatic changes.
EPA is also finalizing several other amendments to 40 CFR part 745,
subparts E (Residential Property Renovation), F (Disclosure of Known
Lead-Based Paint and/or Lead-Based Paint Hazards Upon Sale or Lease of
Residential Property), and L (Lead-Based Paint Activities), including:
conforming changes to the definition of ``target housing;'' conforming
the age requirements throughout the LBP regulations to under six years
old; requiring that application payments, applications, and notices be
submitted electronically; updating the Disclosure Rule warning
statement (Ref. 4); correcting an incorrect reference to the lead-
hazard control pamphlet; deleting obsolete regulatory text where
language is out of date or no longer applicable; and adding
incorporations by reference of two voluntary consensus standards
already included in a relevant definition.
D. Why is the Agency taking this action?
Lead exposure has the potential to impact individuals of all ages,
but it is especially harmful to young children because the developing
brain can be particularly sensitive to environmental contaminants
(Refs. 5 and 6). Because of this, reducing childhood lead exposure is a
priority for both EPA and the Federal government. In December 2018, the
President's Task Force on Environmental Health Risks and Safety Risks
to Children released the Federal Action Plan to Reduce Childhood Lead
Exposures and Associated Health Impacts (Federal Lead Action Plan)
(Ref. 7) to enhance the Federal government's efforts to identify and
reduce lead exposure while ensuring children impacted by such exposure
are getting the support and care they need to prevent or mitigate any
associated health effects. The Federal Lead Action Plan is helping
Federal agencies to work strategically and collaboratively to reduce
exposure to lead and improve children's health. On October 27, 2022,
EPA released the Strategy to Reduce Lead Exposures and Disparities in
U.S. Communities (EPA Lead Strategy). The EPA Lead Strategy lays out
Agency and governmentwide approaches to strengthen public health
protections, address legacy lead contamination for communities with the
greatest exposures and promote environmental justice. It describes how
the Agency will utilize the full suite of EPA authorities, expertise,
and resources to continue to reduce lead exposure. This final rule,
which revises the DLRL and the DLAL, among other regulatory changes, is
an action that EPA committed to undertake in the EPA Lead Strategy
(Ref. 8).
In 2019, EPA re-evaluated the DLHS (described as DLRL moving
forward) (Ref. 2). Based on that evaluation, the final rule revised the
DLHS from 40 [mu]g/ft\2\ and 250 [mu]g/ft\2\ to 10 [mu]g/ft\2\ and 100
[mu]g/ft\2\ for floors and window sills, respectively. However, public
health advocates filed a lawsuit in the U.S. Court of Appeals for the
Ninth Circuit seeking judicial review of the 2019 Final Rule as
insufficiently protective. On May 14, 2021, the Court issued its
opinion on the 2019 Final Rule. The Court held that ``the 2019 Rule
lowers the lead hazard level but not to a level sufficient to protect
health as Congress has directed, because the EPA has looked to factors
in addition to health.'' A Cmty. Voice v. U.S. Env't Prot. Agency, 997
F.3d 983, 992 (9th Cir. 2021). The remedy the Court granted was a
remand without vacatur of the lowered standard, and the Court
instructed EPA to consider only health factors when setting the DLHS
(Ref. 9). The 2023 Proposed Rule was issued to reconsider the DLHS and
DLCL in light of the 2021 Court Opinion, which directed EPA to
``reconsider the DLHS . . . [and] the dust-lead clearance levels . . .
in the same proceeding'' and affirmed that EPA must consider non-health
factors when setting the DLCL (described as DLAL moving forward). A
Cmty. Voice, 997 F.3d at 995. This 2021 Court Opinion led EPA to
undertake a major shift from its approach in the 2019 and 2021 final
rules to the LBP activities program because the Court found that EPA
did not have the authority, when setting the DLHS, to consider non-
health factors. Consistent with the 2021 Court Opinion and based on the
Agency's careful review of the public comments received on the
proposal, EPA is finalizing the DLRL in this rulemaking as proposed,
based on only health considerations, as well as finalizing the proposed
alternative DLAL, based on a variety of factors. See Unit IV. for more
information on the final revisions to the DLRL and DLAL.
E. What are the estimated incremental impacts of this action?
EPA has prepared an Economic Analysis (EA), which is available in
the docket, of the potential incremental impacts associated with this
rulemaking (Ref. 10). The analysis focused specifically on the subset
of target housing and child-occupied facilities affected by this rule.
Although the DLHS and DLCL do not compel specific actions under the LBP
Activities Rule to address identified LBP hazards, the DLHS and DLCL
are directly cross-referenced in certain requirements mandated by HUD
in the housing subject to HUD's LSHR. As such, the analysis estimates
incremental costs and benefits for two categories of events: (1) where
dust-wipe testing occurs to comply with HUD's Lead-Safe Housing Rule;
and (2) where dust wipe testing occurs in response to blood lead
testing that detects a blood lead level (BLL) above State or Federal
action levels. The following is a brief outline of the estimated
incremental impacts of this rulemaking.
1. Benefits
This rule will result in reduced exposure to lead, yielding
benefits to residents of pre-1978 housing from avoided adverse health
effects. Using a 2% discount rate, the annualized benefits of improved
cognitive function in children (quantified using the effect of avoided
IQ decreases on lifetime earnings) are estimated to be $831 million to
$3.1 billion per year; the
[[Page 89419]]
annualized benefits of reduced cases of attention deficit hyperactivity
disorder (ADHD) in children are estimated to be $129 million to $274
million per year; and the annualized benefits of reduced cases of
cardiovascular mortality in adults are estimated to be $614 million to
$6.9 billion per year. The total annualized quantified benefits for all
health endpoints are estimated to range from $1.6 billion to $10.3
billion per year. EPA also analyzed the effect of mothers' exposures to
lead on the risk of low birthweight in their infants, but the analysis
found that the resulting changes in infant birthweight could not be
monetized using EPA's cost-of-illness approach. Nevertheless, the
increases in birth weights from this rule, however small, may still
reduce initial birth-related costs and hospitalization costs incurred
by mothers.
These benefits calculations are sensitive to the range in the
estimated number of lead hazard reduction events triggered by children
with tested BLLs above State action thresholds or the Centers for
Disease Control and Prevention (CDC) blood lead reference value (BLRV)
of 3.5 micrograms per deciliter ([micro]g/dL). The wide range is driven
largely by uncertainty about the BLLs at which action might be taken,
since in many States the action level is currently higher than the
Federal blood lead reference value. The benefit estimates are also
sensitive to the concentration response function used to estimate the
number of reduced cases of premature cardiovascular mortality in
adults, and the assumed rate of soil and dust ingestion by adults. EPA
undertook a rigorous process to identify concentration response
functions to quantify benefits. This included reviewing all available
studies which could be used to develop quantitative relationships
between changes in lead exposure and/or changes in blood lead levels
and changes in health endpoints. EPA evaluated the studies for quality
and potential biases. EPA then developed a separate report for each
health endpoint. In addition to the quality review findings, each
report provides quantitative estimates, based on the identified
functions, of potential changes in the health endpoint and was reviewed
by EPA experts and/or externally peer reviewed. For the analysis of
this final rule EPA has relied on concentration response functions for
four quantified health endpoints that have been extensively reviewed by
the agency and in the case of reductions in IQ losses, low birth weight
and cardiovascular disease premature mortality, externally peer
reviewed. Also, the approach used for IQ has been used in multiple
prior rulemakings and undergone SAB review. EPA will consider updates
to the benefits estimation methodologies and peer review as appropriate
and as new information becomes available in the future.
Additionally, there may be benefits that are unquantified. These
additional benefits might include avoided adverse health effects,
including reduced post-natal growth, delayed puberty, and decreased
kidney function in children, cancer, and impacts on reproductive
function and outcomes in adults.
2. Costs
This rule is estimated to result in quantified costs of $207
million to $348 million per year. These costs are expected to accrue to
landlords, owners and operators of child-occupied facilities,
residential remodelers, and abatement firms. Real estate agents and
brokers may incur negligible costs related to the target housing
definition amendment. The cost calculations are highly sensitive to the
range in the estimated number of lead hazard reduction events triggered
by children with higher BLLs. In the events affected by this rule,
incremental costs can be incurred for specialized cleaning used to
reduce dust-lead loadings (i.e., quantity of lead per unit of surface
area) to below the action levels. In some instances, floors will also
be sealed, overlaid, or replaced, or window sills will be sealed or
repainted. Additional costs may result from the retesting of dust-lead
levels. Additional potential impacts to HUD programs and their
beneficiaries are discussed in Unit V.
3. Small Entity Impacts
This rule will directly impact approximately 18,000 small
businesses of which 85% to 86% have cost impacts less than 1% of
revenues, 12% to 13% have impacts between 1% and 3%, and 2% have
impacts greater than 3% of revenues. These small entities include
landlords, owners and operators of child-occupied facilities,
residential remodelers, abatement firms, and real estate agents and
brokers.
4. Environmental Justice
EPA is finalizing this rulemaking under TSCA Title IV, as explained
in Unit I.B. This rule would address lead exposure, as discussed
throughout this preamble. EPA prepared an Economic Analysis for this
rulemaking that assessed whether there are disproportionate effects to
communities from lead exposure. EPA identified an existing concern:
children living in communities with environmental justice concerns have
significantly higher BLLs than other children (Ref. 11). This rule
addresses health concerns for all affected communities, including those
identified with environmental justice concerns. As identified in EPA's
Economic Analysis, the rule is expected to affect housing units
receiving Federal assistance under HUD's LSHR and housing units with a
child with a BLL above the Federal BLRV, or above a State, or local
blood lead action level. Because, in general, only lower income
households are eligible to receive Federal housing assistance, the
occupants of housing subject to the LSHR (and thus benefitting from the
regulation) are considered an overburdened community. Additional
details on any identified disproportionate impacts to communities with
environmental justice concerns are contained in Unit IX.J. of this
preamble and Section 8.6 of the Economic Analysis.
5. Children's Environmental Health
Consistent with Executive Order 13045, EPA evaluated the health and
safety effects of this action on children. Children are
disproportionately impacted by lead exposure. Children can have greater
exposures than adults because they crawl on floors and often put their
hands and other objects (that can have lead from dust on them) into
their mouths and are more susceptible than adults to adverse health
effects associated with lead exposure due to their rapid anatomical
growth and physiological differences in lead uptake and metabolism.
This rule protects children from these disproportionate environmental
health risks.
This action is also subject to EPA's Policy on Children's Health
(<a href="https://www.epa.gov/children/childrens-health-policy-and-plan">https://www.epa.gov/children/childrens-health-policy-and-plan</a>) because
the rule has considerations for human health and early life exposures.
Accordingly, EPA has evaluated the environmental health or safety
effects of dust-lead exposure on children. The results of this
evaluation are contained in the EA and the Technical Support Document
(TSD), where the health impacts of lead exposure on children are
discussed more fully (Refs. 10 and 12). The documents referenced in
this unit are available in the public docket for this action.
A primary purpose of this rule is to reduce exposure to dust-lead
hazards in target housing where children reside and in child-occupied
facilities. EPA's analysis indicates that there will be approximately
178,000 to 326,000 children under age six per year affected
[[Page 89420]]
by the rule, and 83,000 to 158,000 children between the ages of six and
fifteen per year (Ref. 10). Using a 2% discount rate, the total
annualized quantified benefits for children's health endpoints
(improved cognitive function and reduced cases of ADHD) are estimated
to range from $960 million to $3.4 billion per year.
6. Effects on State, Local, and Tribal Governments
EPA has concluded that this action has federalism implications
because of the potential effects on certain public housing authorities.
These compliance costs result from application of EPA's standards in
HUD's LSHR. While some HUD funding for LBP projects exists, the Federal
government may not provide the funds necessary to pay the entirety of
the costs. As described in Section 8.8 of the EA (Ref. 10), the costs
to public housing authorities that include State, local, and Tribal
governments--estimated at $27 million per year--cover additional lead
hazard reduction activities, cleaning, and dust-lead testing to ensure
that public housing units are in compliance with the LSHR. State and
local governments may provide additional funding to pay for some of
these costs. EPA also estimates annual compliance costs of
approximately $850,000 per year to public school districts that operate
a child-occupied facility built before 1978. Additionally, States that
have authorized LBP activities programs must demonstrate that they meet
any new requirements imposed by this rulemaking and are at least as
protective as the levels at 40 CFR 745.65 and 40 CFR 745.227. However,
authorized States are under no obligation to continue to administer the
LBP activities program, and if they do not wish to adopt the new DLRL
and DLAL they can relinquish their authorization. In the absence of a
State authorization, EPA will administer these requirements. EPA
provides a federalism summary impact statement, which is found in Unit
IX.E.
This action contains a Federal mandate under the Unfunded Mandates
Reform Act (UMRA), 2 U.S.C. 1531-1538, that may result in expenditures
of $183 million or more in 2023 dollars ($100 million or more in 1995
dollars, adjusted for inflation) for State, local, and Tribal
governments, in the aggregate, or the private sector in any one year.
Accordingly, EPA has prepared a written statement as required under
section 202 of UMRA, which is summarized in Unit IX.D. and included in
the public docket (Ref. 13). This action is not subject to the
requirements of section 203 of UMRA because it contains no regulatory
requirements that exceed the inflation-adjusted cost significance
threshold or uniquely affect small governments.
This action will not have substantial direct effects (as specified
in Executive Order 13175) on one or more federally recognized Indian
Tribes. This action neither creates an obligation for Tribes to
administer LBP activities programs nor alters EPA's authority to
administer these programs.
Additionally, this rule would not have any significant or unique
effects on small governments. See Unit IX. for more information on the
executive orders.
II. Background
A. Health Effects of Lead
Lead exposure has the potential to impact individuals of all ages,
but it is especially harmful to young children because the developing
brain can be particularly sensitive to environmental contaminants
(Refs. 5, 6, 14). Ingestion of lead-contaminated dust is a major
contributor to BLLs in children, particularly to those who reside in
homes built prior to 1978 (Refs. 13 and 15). Throughout early
childhood, floor dust contamination is a source of lead exposure with
the potential to affect children's BLLs (Ref. 16). Infants, toddlers,
and other young children are more highly exposed to lead through dust
on floors and other surfaces at home and in child care facilities than
older children and adults because they crawl on floors and often put
their hands and other objects that can have lead from dust on them into
their mouths. This is the main pathway of exposure to lead for young
children (Ref. 5).
Lead exposure in young children can cause neurocognitive
decrements, such as reduction in intelligence as measured by IQ.
Depending on the exposure and other factors, the effect may persist
into adolescence and adulthood (Refs. 5, 6 and 16). In children, lead
exposure can also cause adverse developmental, neurobehavioral,
hematological, and immunological effects (Refs. 5, 6, and 14). In
adults, lead exposure can cause adverse cardiovascular, hematological,
renal, neurocognitive, psychopathological, immunological, and
reproductive effects (Refs. 5, 6, and 14). Lead is also classified as
``reasonably anticipated'' to be a human carcinogen by the National
Toxicology Program (NTP) (Ref. 17) and EPA has concluded that lead
exposure has a ``likely causal'' relationship with carcinogenesis (Ref.
5). In addition to the risk of harmful effects posed to the mother,
lead can be transferred to the fetus during pregnancy with increased
risk of adverse effects on the developing fetus (Refs. 5 and 14). Given
young children's disproportionate exposure to dust-lead in target
housing, this rulemaking principally considers their exposure and
associated adverse health effects, although dust-lead exposure and
adverse health effects in adolescents and adults are also considered
when estimating the rule's benefits (Ref. 10).
Currently available scientific information informs EPA's
understanding of the relationships between exposures to dust-lead,
BLLs, and adverse human health effects. These relationships are
summarized in the Integrated Science Assessment (ISA) for Lead,
finalized in January 2024 (known as the 2024 Lead ISA) (Ref. 5), and
the Agency for Toxic Substances and Disease Registry (ATSDR)
Toxicological Profile for Lead, which was released by the Department of
Health and Human Services in August 2020 (``ATSDR Tox Profile for
Lead'') (Ref. 6). The 2024 Lead ISA is a synthesis and evaluation of
scientific information on the health and environmental effects of lead,
including cognitive function decrements in children (Ref. 5). The 2024
Lead ISA, as well as NIEHS' 2012 NTP monograph on lead, summarize the
scientific evidence regarding potential health effects associated with
low-level lead exposure and also note uncertainties in the data (Refs.
5 and 14). Based on the epidemiological studies and the evidence
available, EPA stated in the 2024 ISA that blood-lead-associated
effects on children's cognition as measured by IQ were observed in
groups of children with mean BLLs as low as 2 [micro]g/dL, and further
that that ``the collective body of epidemiologic studies provides no
evidence of a threshold for cognitive effects in children across the
range of BLLs examined.'' This body of evidence includes studies which
found effects on children's cognition in some groups of children with
prenatal and early childhood blood lead or concurrent blood lead in the
range of <1 to 10 [mu]g/dL (Ref. 5).
For further information regarding lead and its health effects, see
the TSD for this rulemaking and the 2024 ISA for lead (Refs. 5 and 12).
B. Federal Actions To Reduce Lead Exposures
Title X of the Housing and Community Development Act (also known as
the Residential Lead-Based Paint Hazard Reduction Act of 1992 or
``Title X''), codified primarily at 42
[[Page 89421]]
U.S.C. 4822 and 4851 et seq. (Ref. 1), was a Federal response to the
national crisis of childhood lead exposure and assigned
responsibilities to Federal agencies with the overall goal of
developing a ``national strategy to build the infrastructure necessary
to eliminate lead-based paint hazards in all housing as expeditiously
as possible'' (42 U.S.C. 4851(a)(1)). Subtitle B of Title X (106 Stat.
3912 through 3924), addressing lead exposure reduction, added Title IV
to TSCA (codified at 15 U.S.C. 2681 et seq.) (Ref. 18).
Since the establishment of Title X, EPA and HUD have promulgated
both joint and separate regulatory actions in an effort to eliminate
LBP hazards. Those actions include requirements for disclosure of known
LBP or any known LBP hazards (Ref. 4), training and certification
requirements for contractors performing LBP activities (Ref. 19), the
establishment in 2001 of standards that identify lead-based paint
hazards and post-abatement clearance levels (i.e., the DLHS and DLCL)
(in the rule entitled, ``Identification of Dangerous Levels of Lead,''
see 66 FR 1206, January 5, 2001 (FRL-6763-5), also known as the 2001
LBP Hazards Rule) (Refs. 2, 3 and 20), regulations covering renovation
or remodeling activities (Refs. 21, 22 and 23), provisions for
interested States, territories, and Tribes to apply for and receive
authorization to administer their own LBP Activities and renovation,
repair and painting (RRP) programs, and requirements to control LBP and
LBP hazards in federally assisted target housing (Ref. 24). Additional
description of and background on Federal actions to reduce lead
exposure can be found in the 2021 Final Rule (Ref. 3).
In addition, the Federal Lead Action Plan, which was written by the
President's Task Force on Environmental Health Risks and Safety Risks
to Children, consisting of 17 Federal departments and offices, states:
``Lead exposure to children can result from multiple sources and can
cause irreversible and life-long health effects. No safe blood lead
level in children has been identified'' (Refs. 7 and 25). The Agency
has also developed an EPA Lead Strategy to lay out an all-of-EPA plan
to strengthen public health protections and address legacy lead
contamination for communities with the greatest exposures and promote
environmental justice (<a href="https://www.epa.gov/lead/final-strategy-reduce-lead-exposures-and-disparities-us-communities">https://www.epa.gov/lead/final-strategy-reduce-lead-exposures-and-disparities-us-communities</a>). EPA plans to continue
its work to equitably protect people of all races, ethnic groups,
income levels, disabilities, and life stages, including young children
and pregnant women, who are the most vulnerable to the toxic effects of
lead. The actions in this final rule are part of those efforts, as
dust-lead from lead-based paint remains one of the leading causes of
lead exposure in the United States (Ref. 8).
C. Applicability and Uses of DLRL and DLAL
The reportable level and action level reconsidered in this
regulation support EPA's LBP activities program (i.e., inspections,
risk assessments, and abatements) (codified at 40 CFR part 745, subpart
L), which applies to target housing (i.e., most pre-1978 housing) and
COFs (pre-1978 properties where children under 6 years of age spend a
significant amount of time such as daycare centers and kindergartens).
The statutory definition of target housing was amended by Congress in
2017, and EPA is making the necessary conforming regulatory changes,
including finalizing the age to under 6 years of age, in this
rulemaking; see Unit IV.F.1. for more information. Apart from COFs, no
other public or commercial buildings are covered by this proposal.
The DLRL and DLAL are incorporated into requirements for risk
assessment and post-abatement work. When conducted, LBP activities must
be performed by a certified individual or firm (40 CFR 745.220) in
accordance with the work practices outlined in the 1996 LBP Activities
Rule (40 CFR 745.227). EPA administers the LBP activities program only
where States (including the District of Columbia and the Commonwealth
of Puerto Rico), territories, or Tribes are not authorized by EPA to
operate their own lead abatement programs (see 40 CFR part 745, subpart
Q). Currently the States in which the LBP program is administered by
EPA are Alaska, Arizona, Florida, Idaho, Montana, Nevada, New Mexico,
New York, South Carolina, South Dakota, and Wyoming. EPA also
administers the LBP program in the territories of American Samoa, Guam,
Northern Marianas, and the U.S. Virgin Islands, as well as most Tribal
Lands. All other States have EPA-authorized LBP programs. Additionally,
the Cherokee Nation, Upper Sioux Community, Lower Sioux Indian
Community, and the Bois Forte Band of Chippewa have EPA-authorized LBP
programs, which ultimately must be at least as protective of human
health and the environment as EPA's program and provide adequate
enforcement (this rule's impact on authorized programs is discussed
briefly in Unit V.A.).
1. Dust-Lead Reportable Levels
The DLRL support and implement major provisions of TSCA Title IV
and provide the basis for risk assessors to determine whether dust-lead
hazards are present during a risk assessment or a lead hazard screen. A
risk assessment, where dust wipe testing occurs, may be required by the
LSHR in certain circumstances (e.g., for certain properties receiving
Federal assistance) or by other laws or regulations where dust-lead
testing occurs in response to the discovery of a child with a BLL that
exceeds a Federal, State, or local threshold, or in a situation to
comply with State or local requirements. Additional information on the
LSHR and the subparts which require risk assessment are discussed in
the EA (Ref. 10). The objective of a risk assessment is to determine,
and then report, the existence, nature, severity, and location of LBP
hazards in residential dwellings and COFs through an on-site
investigation, which includes both a visual assessment and a collection
of environmental samples. The visual inspection for a risk assessment
includes an examination to determine the existence of deteriorated
(e.g., cracking, flaking, chipping, peeling) LBP or other potential
sources of LBP hazards. The environmental samples include, among other
things, dust wipe samples (taken using documented methodologies as
defined in 40 CFR 745.227(a)(3)) from floors and window sills. Those
samples are required to be analyzed by a laboratory that is recognized
under NLLAP, which is an EPA program that defines the minimum standards
that laboratories must meet to attain EPA recognition as an accredited
testing laboratory (the standards for the program are laid out in the
Laboratory Quality Standards for Recognition) (Ref. 26). A risk
assessor compares the results of the dust wipe samples to the
applicable hazard standard (currently the DLHS and, upon implementation
of this final rule, the DLRL). If the dust-lead loadings from the
samples are at or above the applicable standard, then a dust-lead
hazard is present (40 CFR 745.227(d)).
Ultimately, the risk assessor prepares a risk assessment report for
the property owner or manager, which lists any LBP hazards (including a
dust-lead hazard) that were found and includes any recommendations for
next steps, such as acceptable options for controlling the hazards via
interim controls and/or abatement. These options are intended to allow
the property owner to make an informed decision about what actions to
take to protect the health of current and
[[Page 89422]]
future residents. Under EPA's rule, a risk assessment or risk
assessment report does not compel or require action; rather it simply
provides property owners with recommendations as appropriate (40 CFR
745.227(d)). However, HUD and some State or local governments may
require action depending on whether a LBP hazard is present; see Unit
V. for more information on the impacts of this final rule.
A lead hazard screen also includes a visual inspection and
collection of environmental samples, although it is not as
comprehensive as a risk assessment nor conducted as often. A lead
hazard screen may be used to determine if a full risk assessment is
necessary. During a lead hazard screen, a risk assessor checks for
deteriorated LBP and collects two composite dust samples (in
residential dwellings), one from floors and one from window sills (more
composite dust samples are required in multi-family dwellings or COFs).
Samples are taken using documented methodologies. The risk assessor
prepares a lead hazard screen report but is not required to include
determinations about the LBP hazards or recommendations for interim
controls and/or abatement but could include information on whether a
follow-up risk assessment is warranted (40 CFR 745.227(c)).
Both risk assessments and lead hazard screens can only be performed
by risk assessors certified according to the procedures in 40 CFR
745.226.
2. Dust-Lead Action Levels
The DLAL are incorporated into the post-abatement work practices
outlined in the LBP Activities Rule and represent ``the amount of lead
in dust on a surface following completion of an abatement activity''
(40 CFR 745.227, 745.223) (Ref. 19). TSCA section 401 defines
abatements as ``measures designed to permanently eliminate lead-based
paint hazards'' (15 U.S.C. 2681(1)), while interim controls are
``designed to temporarily reduce human exposure or likely exposure to
lead-based paint hazards'' (40 CFR 745.83 and 745.223). Abatement and/
or interim controls could be recommended in a risk assessment report to
inform the property owner about potential future action(s) they could
take. After an abatement is complete (40 CFR 745.227(e)(8)) and after
interim control work above HUD's de minimis level of paint disturbance,
under HUD's Lead Safe Housing Rule is complete (24 CFR 35.1340(b)), a
risk assessor or inspector determines whether there are any ``visible
amounts of dust, debris or residue,'' which need to be removed before
dust-wipe sampling takes place (40 CFR 745.227(e)(8)). Once the area is
free of visible dust, debris, and residue, and one hour or more after
final post-abatement cleaning ceases, sampling for dust-lead (via dust
wipe samples) can take place and will be conducted ``using documented
methodologies that incorporate adequate quality control procedures''
(40 CFR 745.227(e)(8)). Only a properly trained and certified risk
assessor or inspector can conduct clearance sampling. An NLLAP-
recognized laboratory must analyze the dust wipe samples and a risk
assessor or inspector must compare the results from window sills,
floors, and window troughs to the appropriate DLAL.
Every post-abatement sample must test below the DLAL in order to
fulfill the post-abatement work practices of the LBP Activities Rule.
If a single sample is equal to or greater than the corresponding DLAL,
then the abatement fails to be successfully completed and the
components represented by the failing sample must be recleaned and
retested (40 CFR 745.227(e)(8)). After all dust wipe samples show dust-
lead loadings below the DLAL, an abatement report is prepared (in
accordance with the requirements in 40 CFR 745.227(e)(10)), copies of
any reports required under the LBP Activities Rule are provided to the
building owner (and to potential lessees and purchasers under the LBP
Disclosure Rule by those building owners or their agents), and all
required records are retained by the abatement firm or by the
individuals who developed each report for no fewer than three years (40
CFR 745.227(i)).
D. Limitations of DLRL and DLAL
The DLRL are intended to identify dust-lead hazards during risk
assessments, while the DLAL are part of post-abatement work practices.
Both regulatory values have several key limitations. Since the DLRL and
DLAL were established and revised for the purposes of Title X and TSCA
Title IV only, they do not apply to housing and COFs built during or
after 1978, nor do they apply to pre-1978 housing that does not meet
the definition of target housing (40 CFR 745.61 and 745.223). If one
chooses to apply the DLRL or the DLAL to situations beyond the scope of
Title X and TSCA Title IV, care must be taken to ensure that the action
taken in such settings is appropriate, and that the action is adequate
to provide any necessary protection for children or other individuals
exposed.
These standards cannot be used to identify that housing is free
from all risks from exposure to lead including but not limited to dust-
lead, soil-lead, or lead in drinking water, as risks are dependent on
many factors. For instance, the physical condition of a property that
contains LBP may change over time, resulting in an increase in risk.
Plus, EPA's DLRL do not require the owners of properties covered by
this rule to evaluate their properties for the presence of dust-lead
hazards, nor to take action if dust-lead hazards are identified
(although these standards can be incorporated into certain requirements
mandated by State, Tribal and local governments, as well as other
Federal agencies). Additionally, consistent with the 2021 Court Opinion
that instructed EPA to consider only health factors when setting the
DLHS (described as DLRL moving forward) and affirmed that EPA must
consider other factors (i.e., reliability, effectiveness, and safety)
when setting the DLCL (described as DLAL moving forward), EPA is
finalizing the DLAL as greater than the DLRL based on EPA's
consideration of other factors (e.g., laboratory capabilities/capacity,
and achievability after an abatement). As a result and given the change
in the definition of abatement discussed in Unit IV.E. of this
preamble, there may be dust-lead remaining that meets the definition of
a LBP hazard after an abatement is considered complete, due to dust-
lead levels that are reportable but are less than the DLAL. Also, as
has been the case historically, achieving the DLAL after an abatement
does not mean that the home is lead safe or is free from all exposure
to lead, including from other media such as soil-lead or lead in
drinking water. EPA will continue coordinating with other Federal
agencies to encourage best practices for owners and occupants of post-
abatement properties to conduct ongoing maintenance that will help to
continue to lower dust-lead levels, as well as working collectively
among the Agency's offices to reduce overall lead exposure through all
pathways.
E. Litigation Overview
As previously discussed, EPA revised the DLHS to 10 [mu]g/ft\2\ for
floors and 100 [mu]g/ft\2\ for window sills in a final rule in July
2019 (Ref. 2). On May 14, 2021, in response to a Petition for Review
that was filed shortly after the final rule was published, the Court
remanded the 2019 Final Rule without vacatur and directed EPA to
revisit it in conjunction with a reconsideration of the DLCL (Ref. 9).
In its opinion accompanying the remand, the Court instructed EPA to
consider only health factors when setting the DLHS (described by EPA as
DLRL
[[Page 89423]]
moving forward) and affirmed that EPA must continue to consider non-
health factors when setting the DLCL (described by EPA as DLAL moving
forward). Specifically, the 2021 Court Opinion held that EPA's 2019
Final Rule ``looked to other factors, including feasibility and
efficacy,'' when setting the DLHS, instead of ``set[ting] the hazard
standards at the point at which the level [of] dust-lead creates
hazards to human health'' A Cmty. Voice, 997 F.3d at 989 and 990. The
Court also held that ``TSCA [Title] IV gives the EPA latitude to
consider `reliability, effectiveness, and safety' '' when promulgating
regulations ``[w]ith respect to implementation, including abatement,''
thus enabling consideration of practicability when setting the DLCL.
Id. at 995. The Court explained that ``[t]his is in line with the
overall statutory scheme that differentiates between identification of
hazards and implementation of remedial measures.'' Id. The Court also
explained elsewhere in the 2021 Court Opinion that, if an agency relies
on uncertainty for regulatory action or inaction, the agency must
``provide reasons why uncertainty justifies their actions'' Id. at 993.
Consistent with the 2021 Court Opinion, EPA is finalizing revisions to
the DLRL in this rulemaking based only on health considerations.
In addition, the Court held that EPA violated TSCA Title IV by
leaving the soil-lead hazard standards (SLHS) at the values set in
2001, reasoning that EPA had an ongoing duty to update the standards.
The SLHS identify lead-contaminated soil at target housing and pre-1978
COFs that would result in adverse human health effects. Soils that
contain lead at levels determined to be hazardous to human health are
considered contaminated. Lead inspectors, risk assessors, and abatement
professionals use the SLHS to determine if soil-lead hazards are
present and to inform options for reducing risk, such as during the
risk assessment process. Due to resource considerations and to act as
expeditiously as possible to revise the DLRL and DLAL, EPA will address
the SLHS in a separate rulemaking. (For more background on resource
constraints under TSCA, please see Congressional testimony from EPA
leadership (Refs. 27, 28, 29, 30 and 31)). EPA listed this SLHS
rulemaking in the Spring 2024 Unified Agenda of Regulatory and
Deregulatory Actions under RIN 2070-AL12 as a long-term action,
indicating the Agency's commitment to meet the statutory requirement of
addressing the SLHS revision but indicating that the Agency does not
expect to propose this action in the 12 months following the agenda
entry (Ref. 32). EPA has, however, initiated work on the SLHS
rulemaking and is continuing to allocate additional resources to it as
this reconsideration rulemaking is finalized. The Agency also intends
to build off of the technical analysis utilized for this rulemaking for
the SLHS rulemaking, mirroring where possible so as to reduce resource
constraints and considerations. EPA plans to issue a proposed SLHS
rulemaking in 2026.
The Court also held that, to be consistent with its health-only
interpretation of a LBP hazard (i.e., soil, dust), the definition of
LBP must ``encompass all levels of lead in paint that lead to adverse
human health effects.'' A Cmty. Voice, 997 F.3d at 992. The Court
stated that ``EPA ha[d] not explained why uncertainty justifies its
decision to leave the definition of lead-paint as-is.'' Id. at 993. The
Court also noted that much knowledge has been gained since Congress
adopted the 1992 definition and that the U.S. Consumer Product Safety
Commission (CPSC) has adopted a regulation that bans the production of
paint with lead content of over 0.009 percent by weight. The CPSC
standard, however, applies to new paint while TSCA is concerned with
the hazards posed by existing paint in pre-1978 structures and
different information and considerations are relevant in that context.
The definition of LBP (1.0 milligrams per square centimeter or more
than 0.5 percent by weight) is incorporated throughout the LBP
regulations of both EPA and HUD, and application of this definition is
central to how LBP programs function. In the 2019 Final Rule, EPA
discussed the Agency's need for more information to establish a
statistically valid causal relationship between concentrations of lead
at low levels in paint and dust lead loadings that cause lead exposure.
Additionally, information is still needed to quantify the direct
ingestion of paint through consumption of paint chips or through
teething on painted surfaces. Finally, it is important to understand
how capabilities among various LBP testing technologies would be
affected under a possible revision to the definition, such as field
portable X-ray fluorescence devices (XRFs), which are the primary tools
for lead inspections and risk assessments. They are calibrated to the
current definition of LBP, and so EPA needs to fully understand the
repercussions such a revision to the definition may have on these
portable field technologies to ensure the technological feasibility.
On November 1 and 2, 2023, EPA and HUD held a virtual public
workshop to hear stakeholder perspectives on specific topics related to
detection of and exposure to potential lead hazards from existing
residential LBP and to obtain additional information needed to address
data gaps related to the definition of LBP that were outlined in the
2019 Final Rule. This virtual workshop was held over two days and
gathered critical input on innovative methods to address LBP and reduce
lead exposure across the United States.
In preparation for the LBP technical workshop, the Agency performed
a literature review for sources relevant to the definition of LBP,
consulted other Federal agencies, and refreshed materials that were
developed for the 2019 rulemaking. While the data gaps did not change
since the 2019 rule, they were refined to add further specificity,
which allowed for a more targeted scope for both continued
investigation and for the technical workshop held in November 2023. The
more specific data gaps that EPA continues to investigate include
empirical data on the relationship between low levels of lead in paint
and dust-lead, as well as data on the common exposure scenarios that
may inform this relationship (for example, dust-lead generation during
a renovation scenario versus slowly deteriorating paint). Currently the
available empirical data and modeling approaches for estimating the
relationship between lead content in on-the-wall paint and lead in
related environmental media, including dust, are applicable at or above
the current LBP definition. EPA believes that to use the available
empirical data and modeling approaches to estimate dust-lead loadings
at low levels of lead in paint (particularly levels that are lower than
the current definition by an order of magnitude or more) will introduce
significant uncertainty to any estimations. Data and models applicable
to lower levels of lead in paint are needed to develop an approach to
estimate dust-lead from low levels of lead in paint, which will allow
EPA to estimate incremental blood lead changes and associated health
effect changes that may occur due to low levels of lead in paint. For
the ingestion exposure pathway, EPA is exploring possible modeling
solutions as well as seeking quantitative measures of ingestion and
exposure (such as data on duration and frequency of consumption, and
common paint chip characteristics). Studies on this subject have
documented this behavior as a risk factor for exposure to
[[Page 89424]]
lead from LBP; however, the studies have not provided quantitative
estimates of paint ingestion, which are needed to quantify exposure.
Lastly, EPA continues to investigate constraints to the field
measurement options for low levels of lead in paint. Different
technologies have different limitations in accuracy, processing time,
detection limits, accessibility, and destructiveness among other
factors. These practical considerations are important to consider in
understanding how a change in the definition may affect the ability of
the regulated community to use certain technologies, potentially
impacting the residents of target housing and occupants of COFs. On top
of these data gaps and as outlined in the document Definition of Lead-
Based Paint Considerations from May 2019 (Ref. 33), EPA is exploring
the relationship between the two different units used in the current
definition (milligram per square centimeter and percent by weight) to
inform whether and, if so, how to develop a conversion between the two.
The search for relevant information to develop the conversion and
exploration of the uncertainty involved with such a conversion is
underway.
The presenters at the workshop covered a wide range of topics. One
of the most prominent discussions, covered by several presentations,
was the potential and limitations of extending current technologies
(particularly the XRF analyzer) to thresholds at or below the current
definition, as well as the reliability of the analyzer's lead detection
estimates in general. Also discussed extensively were the capabilities
of other testing methods, strategies to use these methods alongside XRF
testing, and the impact on test kits of lowering the definition of LBP.
The challenge of characterizing the relationship between mass-per-mass
and mass-per-surface area definitions of LBP was also examined, with
one speaker presenting a regression analysis to derive an overall
relationship between the two.
Other topics discussed during the workshop included trends in
childhood lead exposure the capability of community outreach and
involvement in assisting to address the LBP problem, and to some extent
the relationship between lead in paint and dust-lead. On the latter
point, however, the relationship between low levels of lead in paint
and levels of lead in dust-lead was not examined in depth. Nor was the
impact of paint condition, maintenance, age, and other factors. The
ingestion pathway was also not examined. EPA and HUD continue to
process the information gathered and the status of the data gaps that
remain. Also, EPA and HUD hope to gain additional insight from a wider
audience via public comments on the workshop's docket, which was open
until June 30, 2024.
Similar to the SLHS rulemaking, due to resource considerations and
EPA's interest in acting as expeditiously as possible to revise the
DLRL and DLAL and to hold the aforementioned LBP technical workshop,
EPA will address the definition of lead-based paint in a separate
rulemaking. EPA has listed this rulemaking on the definition of LBP in
the Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions
under RIN 2070-AL11 as a long-term action, indicating the Agency's
commitment to meet the statutory requirement of addressing the
definition of LBP revision but that the Agency does not expect to
propose this action in the 12 months following the agenda entry (Ref.
34).
Rulemakings such as those necessary for revisions to SLHS and the
definition of LBP are complex, highly resource-intensive activities. A
rulemaking's development generally entails scientific, economic, legal,
and other technical analyses. For many rulemakings, this includes
research and data gathering, which itself can sometimes necessitate
exercising other information collection tools and following appropriate
procedural requirements (e.g., Paperwork Reduction Act). To develop a
rulemaking, EPA also often consults with governments and key
stakeholders. Federal law may require such consultations based on
anticipated regulatory impacts (e.g., the Unfunded Mandates Reform Act
and the Regulatory Flexibility Act). Additionally, various executive
orders may also require the Agency to engage in such consultations.
A rulemaking package often requires the development of complex
supporting documents including an EA and a TSD, similar to those
included alongside this reconsideration rulemaking (Refs. 10 and 12). A
complete TSD includes several components that may require internal and
external stakeholder dialogue and scientific peer review, including
model and input data revisions, health and exposure metrics of
interest, environmental fate and exposure mechanisms for either soil or
the definition of LBP, characterization of uncertainties in modeling,
and literature reviews (which have not been done for soil since before
the 2001 LBP Rule was finalized). If existing models and analytical
methods are insufficient to conduct the analysis to support the
rulemaking, then they must be developed as part of the technical work
done in support of the rulemaking effort. Developing new models can
take a considerable length of time and novel analyses may require peer-
review, further extending the rulemaking timeline. The magnitude and
effort of an SLHS TSD would mirror previous DLHS and DLCL TSDs (and the
TSD for this rule); see the technical documents prepared in support of
the 2019 Final Rule, the 2021 Final Rule, or this reconsideration
rulemaking (Refs. 12, 35, and 36).
An EA includes various components such as a description of the need
for Federal regulation; a profile of affected industries and
populations; an overview of existing Federal, State and local
regulations; a specification of the baseline state of the world and
estimate of the number of events affected by the regulation; thorough
analysis on the consequences of regulatory policy being considered and
how regulated entities will respond; quantification and monetization of
the regulation's costs, benefits, and net benefits; a description of
unquantified or qualitative benefits; and an assessment of uncertainty
surrounding estimates. An EA also includes various additional analyses
related to statutory compliance and executive orders, including but not
limited to small business impacts, unfunded State, local, or Tribal
mandates, paperwork reduction, environmental justice, protection of
children, federalism, coordination with Tribal governments, and energy
effects. A rulemaking also involves developing Federal Register
documents to present, generally, the preamble to and regulatory text of
the proposed and final rule. Such published documents reflect the
culmination of the development and review of the complex supporting
documents and the resulting decision-making, which includes internal
steps at the Agency to reach officewide agreement, as well as external
to the Agency, such as holding potential public consultations,
completing interagency review and convening a Small Business Advocacy
Review Panel, as necessary. These processes can also take many months
or years. The proposed and final rules also present statutory and
executive order review analyses.
The current rulemaking on the DLRL and DLAL is one more step toward
complete implementation of TSCA Title IV. Given the complications for
the SLHS and the definition of LBP discussed earlier in this section,
EPA does not believe that either the SLHS or the definition of LBP
could have been reconsidered on this current
[[Page 89425]]
rulemaking's timeline. Instead, EPA will reconsider the SLHS and the
definition of LBP as important next steps. Courts ``have recognized
that, under the `pragmatic' one-step-at-a-time doctrine, `agencies have
great discretion to treat a problem partially' and `regulat[e] in a
piecemeal fashion.' '' Transportation Div. of the Int'l Ass'n of Sheet
Metal, Air, Rail & Transportation Workers v. Fed. R.R. Admin., 10 F.4th
869, 875 (D.C. Cir. 2021) (quoting Ctr. for Biological Diversity v.
EPA, 722 F.3d 401, 409-10 (D.C. Cir. 2013)); cf. Massachusetts v. EPA,
549 U.S. 497, 524 (2007) (recognizing that ``[a]gencies, like
legislatures, do not generally resolve massive problems in one fell
regulatory swoop''). EPA intends to conduct rulemakings on the SLHS and
the definition of LBP, as identified in the Spring 2024 Unified Agenda
of Regulatory and Deregulatory Actions, to address the issues
identified by the Ninth Circuit in its May 2021 opinion (Refs. 9, 32
and 34).
F. Public Comments Summary
The proposed rule provided a 60-day public comment period, which
ended on October 2, 2023. EPA received a total of 21,309 comments in
docket number EPA-HQ-OPPT-2023-0231. This included 393 unique comments
that were submitted as well as the transcript from a public webinar
that EPA held on the proposed rule on August 23, 2023, where numerous
public comments were received verbally. The majority of the 21,309
comments were submitted as part of five mass mail campaigns (two that
expressed support for the proposed rule and three that did not). One of
the supportive mass mail campaigns accounted for roughly 20,723 or 97%
of the total number of comments. Comments were received from private
citizens, landlords, State/local governments (including State health
departments), potentially affected lead-based paint businesses, lead
laboratories, trade associations, non-governmental organizations and
environmental and public health advocacy groups.
Numerous commenters supported EPA's proposed ``greater than zero''
approach to revising the DLHS (described as DLRL moving forward)
codified as ``any reportable level'' based on their view that there is
no safe level of lead exposure (e.g., two commenters pointed to a
``voluminous body of recent research [that] documents unequivocally
that no level of lead exposure is safe for a fetus or young child'').
Public commenters also supported the proposed approach for a variety of
related reasons, such as making the public more aware of the risk dust-
lead may pose, preventing more children from lead poisoning, and
emphasizing the importance of cleaning. Commenters also noted their
view that prevention is the best solution to lead exposure in children,
and that due to neurological and cognitive development, children are
particularly susceptible to these impacts. (Note that interventions
that are implemented before there is evidence of a disease or injury
are defined as primary preventions by CDC (Ref. 37)).
For the proposed approach there were several key concerns, raised
predominately by lead-based paint professionals, laboratories and trade
associations, that fall into several general categories: concerns over
dust-lead source and that the DLRL would fall below background levels
of dust-lead; laboratory concerns including that a laboratory's
reportable level can vary considerably between establishments; impacts
this DLRL would have on existing housing stock, particularly affordable
housing; the cost of implementation; concerns over decoupling DLRL from
DLAL; and possible liability issues and confusion within the public and
regulated community due to leaving a hazard behind after an abatement
is considered complete. For more information on the rationale of the
final DLRL approach of ``any reportable level'' see Unit IV.B.
Multiple commenters, predominately advocacy organizations,
supported EPA's proposed DLCL (described as DLAL moving forward) of 3
[micro]g/ft\2\, 20 [micro]g/ft\2\, and 25 [micro]g/ft\2\, for floors,
window sills and window troughs, respectively, in order to protect
children from lead exposure. EPA also received numerous public comments
opposing the reduction in the DLAL, and requests that the values remain
at the current levels of 10 [micro]g/ft\2\, 100 [micro]g/ft\2\, and 400
[micro]g/ft\2\, for floors, window sills and window troughs. A few
commenters also supported the proposed alternative DLAL of 5 [micro]g/
ft\2\, 40 [micro]g/ft\2\, and 100 [micro]g/ft\2\, for floors, window
sills and window troughs. The concerns public commenters highlighted
were related to laboratory technology shifts, costs, turnaround times,
laboratory capacity, and the practicability/achievability of the lower
levels of 3 [micro]g/ft\2\, 20 [micro]g/ft\2\, and 25 [micro]g/ft\2\.
EPA received several comments during the public comment period from
a variety of organizations including industry, environmental and public
health advocacy organizations, among others, requesting that EPA revise
the terminology of the standards (specifically the terms of DLHS and
DLCL) in order to better communicate to the public their purpose and to
reduce confusion. Another concern raised by numerous public commenters
was the confusion created by the messaging of ``greater than zero''
(which was the terminology used to describe ``any reportable level'' in
the proposed rule). Under this final rule the term ``greater than
zero'' is being replaced with ``any reportable level'' in the preamble
and within any implementation materials that accompany this final rule.
For more information on the terminology changes see Unit IV.A.
In this preamble, EPA has responded to the major comments relevant
to this final rule. In addition, the more comprehensive version of
EPA's response to comments related to this final action, including
comments not mentioned in this preamble, can be found in the Response
to Comments document that accompanies this rulemaking (Ref. 38).
III. Technical Analyses
In its evaluation of options for reconsidering the DLRL and DLAL,
EPA estimated children's BLL and associated IQ decrements expected to
result from lead exposures with each option. These estimates provide
the means to quantitatively compare risk posed to young children by
exposure to the dust-lead loading levels analyzed. EPA also estimated
BLL in adolescents and adults for the various dust-lead loading levels,
and associated risk of ADHD diagnosis, cardiovascular mortality risk,
and changes in low birthweight, to inform the benefits analysis
accompanying this rule. The TSD (Ref. 12) and EA (Ref. 10) accompanying
this rulemaking provide the complete analyses and associated estimates
of expected impacts of the candidate DLRL and DLAL options on BLLs of
exposed children, adolescents, and adults in target housing and
associated changes in occurrence of adverse health impacts. See Unit
IV. on the rationale for the revisions to DLRL and DLAL.
The TSD uses both mechanistic and empirical models to predict
possible BLLs in children that reside in target housing and are exposed
to homogenous candidate values for dust-lead levels (e.g., candidate
options for the DLRL or DLAL); the TSD also probabilistically accounts
for variation in children's BLLs due to other sources of lead exposure
and differences in biological response to lead exposure. The first
approach uses mechanistic modeling of lead exposure and uptake that
takes into account age-specific ingestion rates, activity patterns, and
background exposures. Specifically, the mechanistic
[[Page 89426]]
blood lead modeling for children in this rulemaking reflects the
application of an extensively peer-reviewed model (the Stochastic Human
Exposure and Dose Simulation--Integrated Exposure Uptake Biokinetic
model coded in R, referred to as R-SHEDS-Pb) using updated data sources
and tailored to the dust-lead target housing scenario, described in
depth in appendix E of the TSD. The empirical approach used data that
includes co-reported dust-lead and BLL measurements in the homes of
children; these dust-lead and BLL data are used to develop an empirical
relationship to estimate BLLs for each candidate dust-lead level.
Estimates derived from the two approaches (mechanistic and empirical)
are compared; and similarity between the results increased confidence
in the estimates of the relationship between dust-lead loadings and BLL
(Section 9.3 of the TSD, Ref. 12). The various components of the model
and input parameters used for children in this rulemaking have been the
subject of multiple Science Advisory Board Reviews, workshops and
publications in the peer reviewed literature focused on dust-lead
(Refs. 15, 39, 40, 41, 42, and 43).
The mechanistic blood lead modeling for adolescents and adults in
this rulemaking was performed using an extensively peer-reviewed model
(the All-Ages Lead Model, referred to as AALM) using updated data
sources tailored to the dust-lead target housing scenario as was done
for children using R-SHEDS-Pb (See section 4 and appendix F of the
TSD). The TSD uses AALM version 3.0 to predict possible BLLs in
adolescents and adults that reside in target housing and are exposed to
dust-lead loadings at the candidate DLRL and DLAL. This model takes
into account age-specific ingestion rates and background exposures
(Section 4.2.1 of the TSD) (Ref. 12). The various components of the
AALM version 2.0 model and input parameters have been the subject of a
Science Advisory Board review (Ref. 44) and the AALM version 3.0 model
been used to support recent EPA guidance and rulemakings (Ref. 45 and
46).
Detailed discussion of the limitations and uncertainties in blood
lead modeling at the low dust-lead exposures and associated BLLs
considered for this rulemaking can be found in Sections 13.3.1 and
13.3.2 of the TSD (Ref. 12). Integrated Exposure Uptake Biokinetic
Model for Lead in Children (IEUBK) version 2.0, as a standalone
biokinetic model, was evaluated for performance in groups of children
for which the geometric mean BLL is as low as 2.3 [micro]g/dL (Ref.
47). Mean estimated BLLs for groups of children at some of the lowest
levels of dust lead exposure modeled for this rulemaking were lower
than this value (between 0.81 and 1.12 [micro]g/dL depending upon age)
and are outside the range for which the underlying biokinetic model
(IEUBK) has been evaluated. In order to address this lack of model
evaluation at BLLs of interest, EPA conducted an evaluation of the R-
SHEDS-Pb model used in this analysis with a dataset for which the
geometric mean BLL in children aged 1 to 2 years old is 1.09 [micro]g/
dL. This evaluation found BLL estimates for 1- to 2-year-old children
from the R-SHEDS-Pb model agreed well with the reference dataset at low
percentiles, at the median, and at the 95th percentile. See table 13-2
and appendix D in the TSD (Ref. 12). AALM version 3.0 was validated
against a panel of datasets including pharmacokinetic data from dosing
studies in adults (Ref. 48), biomonitoring data including longitudinal
studies of lead workers (Refs. 49, 50), and biokinetic studies in
infants with estimated lead intakes (Refs. 51, 52). Additionally, AALM
version 3.0 was evaluated at relatively low exposures and associated
BLLs (~1 [micro]g/dL) against the IEUBK predictions for children at
birth until age 7 and the predictions were found to compare well, with
a 5% discrepancy (0.07 [micro]g/dL) between the two models at age 2 for
a 10 [micro]g/day continuous lead dose (See Figure 13-1 in the TSD).
In contrast to the TSD, which estimates the health risk and
exposure associated with dust-lead loading candidates for a
hypothetical population of children in target housing without
consideration to how many children are actually affected by the rule,
the EA estimates benefits that accrue to only the subpopulation that
would be impacted by the final rule's revisions. Rather than assuming
all households living in target housing are impacted by the regulatory
change, the EA instead estimates benefits solely for instances when
dust-lead levels would be tested. These instances of dust wipe testing
are henceforth referred to as ``triggering events.'' For the
subpopulation of individuals who are affected by these events, the EA
estimates quantified benefits from avoided lead-associated IQ
decrements, avoided cases of ADHD or cardiovascular mortality, and
changes in birthweight. The EA uses real world data to characterize:
(1) variability in the housing stock that is affected; (2) how surface-
by-surface dust-lead loadings change due to the DLRL/DLAL; (3) the
number of individuals living in affected housing units; and (4)
resultant changes in BLLs and IQ decrement, ADHD, low birthweight, and
cardiovascular mortality risk that are expected. In modeling the
relationships between dust-lead loadings and BLL/IQ, the EA presents
results based on both the empirical and mechanistic approaches laid out
in the TSD. EPA considered several methods to quantitatively represent
the relationship between BLL and IQ for BLLs below the lowest lifetime
average BLL (1.47 [micro]g/dL) in the set of epidemiologic studies
which the BLL-IQ concentration-response equations were based upon, and
a range of IQ decrement estimates based on the methods considered are
presented in the TSD and EA (see TSD section 6 and EA Section 6.4). The
IQ decrement estimates presented in Unit IV. and in Section 12 of the
TSD were derived using a linearization method, which resulted in the
highest estimates of IQ decrements.
Both the TSD and the EA present estimated changes in BLL and
associated changes in health effects (IQ decrement, ADHD, low
birthweight, and cardiovascular mortality risk). However, these
estimates represent populations of exposed individuals characterized in
differing ways. The TSD presents the expected response for a
hypothetical dust-lead exposure, accounting for varying sources of
background exposure (e.g., food, soil, water) and biological
variability. The EA estimates expected responses to triggering events,
recognizing that exposures at the higher end of the distribution of
hypothetical conditions in the TSD are not realized in all target
residences because dust-lead levels across target housing are generally
lower than the current hazard standards and clearance levels (10
[micro]g/ft\2\ and 100 [micro]g/ft\2\ on floors and window sills
respectively) (Ref. 53) and existing abatements/interim controls
typically overshoot the current clearance levels considerably (Ref.
54). Thus, the distributions of BLLs and health effects estimated in
the TSD represent the impact of individuals' exposures to hypothetical
dust-lead levels while the EA estimates distributions of BLLs and
health effects across individuals living in housing that is directly
impacted by this rule. The analyses that EPA developed and presented
for young children in the TSD and EA for this rule were specifically
designed to estimate BLLs and associated risk of effects on IQ that
might accrue to the population of interest (i.e., children living in
pre-1978 housing). EPA notes that its different program offices
estimate exposures for different populations, different media,
[[Page 89427]]
and under different statutory requirements and thus different models or
parameters may be a better fit for their purposes. Accordingly, the
approach and modeling parameters chosen for this rulemaking should not
necessarily be construed as appropriate for, or consistent with, those
of other EPA programs or those of other Federal agencies.
Public comments were received on the TSD and EA accompanying the
proposed rule. EPA's responses are included in Sections 9 and 10 of the
Response to Comments filed under docket number EPA-HQ-OPPT-2023-0231.
IV. Final Rule
As explained in Unit II.E., the 2021 Court Opinion of the U.S.
Court of Appeals for the Ninth Circuit held that EPA must reconsider
the DLHS in conjunction with the DLCL (described by EPA as DLRL and
DLAL moving forward) (Ref. 9). EPA carefully considered all public
comments related to the proposed rule and is finalizing a nomenclature
change from the terminology of DLHS and DLCL, to the dust-lead
reportable level (abbreviated as DLRL) and the dust-lead action level
(abbreviated DLAL), as well as revisions to lower both standards. In
this final rule, EPA is revising the DLHS from 10 [micro]g/ft\2\ and
100 [micro]g/ft\2\ for floors and window sills to a non-static DLRL
represented by any reportable level of dust-lead as analyzed by an
NLLAP-recognized laboratory. Lowering the DLRL (independent of the DLAL
revisions) provides the regulatory benefit of additional disclosure of
LBP hazards in target housing and COFs. This results in an estimated
increase in individuals who are aware of the presence of dust-lead and
the various actions that can be taken to minimize dust-lead hazards and
take actions to protect themselves from exposure (even if LBP is not
present). See Unit IV.B. for additional information describing the
final DLRL of ``any reportable level.''
EPA is also finalizing revisions to the DLCL from 10 [micro]g/
ft\2\, 100 [micro]g/ft\2\ and 400 [micro]g/ft\2\ for floors, window
sills, and troughs to a DLAL of 5 [micro]g/ft\2\, 40 [micro]g/ft\2\,
and 100 [micro]g/ft\2\, which are the current DLCL in New York City
(NYC). See Unit IV.C. for additional information describing the final
DLAL.
A. Nomenclature Changes
EPA received several comments during the public comment period from
a variety of organizations including industry, environmental and public
health advocacy organizations, a local health department, the Attorneys
General of several States and the District of Columbia, and a lead-
based paint professional, suggesting EPA revise the terminology of DLHS
and DLCL in order to better communicate to the public the purpose of
the standards and to reduce confusion. Commenters highlighted that
removing the use of ``hazard'' would be beneficial since it could imply
that immediate action is needed or create confusion within the public
when no action is recommended. Commenters also emphasized that changing
the use of ``clearance'' could avoid any misconception that after an
abatement no hazards remain. One commenter even noted that because this
rule is shifting how the standards have worked together historically
(i.e., decoupling the hazard standards and clearance levels for floors
and sills), it may be helpful to both the public and the regulated
community to make this shift even more transparent with a terminology
change. Another commenter noted that EPA should consider how these
terms are used in other Federal and State regulations.
EPA received recommendations for new terminology for both
standards, including dust-lead hazard level, disclosure level, lead
dust disclosure level, contamination level, or lead-contaminated dust
goal for the DLHS and action level or dust-lead action level for the
DLCL, among other suggestions. EPA is finalizing a nomenclature change
from the term DLHS to dust-lead reportable level (abbreviated DLRL) and
from the term DLCL to dust-lead action level (abbreviated DLAL). The
new term DLAL received the most support by public commenters, with the
largest number of requests, whereas EPA believes DLRL captures the
essence of the suggestion from the public commenters but avoids any
confusion with the already well-established Disclosure Rule or
disclosure program.
While this exact terminology was not in the proposed rulemaking,
EPA recognizes the value of these changes and agrees with commenters
that the new terminology more clearly communicates the intention of the
standards to the public and the regulated community. EPA believes this
updated nomenclature aligns better and more intuitively with the
operational function of the amendments EPA had proposed and is
finalizing in this action. For example, the new terminology makes it
clear that if a dust-lead loading falls below the DLAL but above the
DLRL, that dust-lead is still present in the environment, but that the
levels are below those prioritized for action. To implement this
nomenclature change, EPA is adding a definition of ``action levels'' in
40 CFR 745.223 to replace ``clearance levels'' and making other minor,
conforming amendments in phrasing of the regulations. The term DLAL
also emphasizes its new role, as the trigger for the recommendation for
action due to the changes to the definition of abatement for dust-lead
hazards (see Unit IV.E. for more information on the revisions to the
definition of abatement). Ultimately, when the regulated community
clears a project after an abatement, it would be to below the action
levels. EPA intends any continuing use of the ``clearance'' term in the
abatement context to describe such efforts (i.e., achieving loadings
below the action level). EPA also appreciates that the reportable
terminology in particular aligns with the regulatory definition that is
being finalized of ``any reportable level.'' Note that within EPA's
regulatory landscape, dust-lead levels that are at or above the DLRL
are still considered a LBP hazard, specifically a dust-lead hazard. EPA
believes that messaging to the public and regulated community should
revolve around explaining that any dust-lead levels at or above DLRL
are above the level at which the LBP community must report a hazard on
a risk assessment report, but that EPA recommends action only when
levels are above the DLAL. Language around a reportable level should
still clearly communicate that a dust-lead hazard is still present.
Another concern raised by numerous public commenters was the
confusion caused by the messaging of ``greater than zero'' (which was
the terminology used to describe ``any reportable level'' in the
proposed rule). In this final rule the terminology ``greater than
zero'' is being replaced with ``any reportable level'' in the preamble
and within any implementation materials that accompany this final rule.
EPA agrees with the public that the concept of GTZ is confusing as it
implies that if one has dust-lead loadings below any reportable level
then there is zero or no dust-lead present. EPA wants to avoid this
misconception and will refer to what was previously ``greater than
zero'' as the ``any reportable level'' approach to avoid any further
confusion.
A more comprehensive version of EPA's response on these
communication and nomenclature comments can be found in Section 5 of
the Response to Comments document that accompanies this final rule
(Ref. 38).
B. Dust-Lead Reportable Level Approach
In the 2001 LBP Hazards Rule EPA discussed the dilemma the Agency
[[Page 89428]]
faced when establishing a dust-lead hazard standard, especially the
challenges associated with choosing ``which [BLLs] are truly
hazardous'' and how to interpret the statutory criteria from TSCA
section 401 (i.e., ``would result in adverse human health effects'' (15
U.S.C. 2681(10)) given the uncertainties that existed (Ref. 20). As a
result, historically EPA took a pragmatic approach to setting the DLHS
(described moving forward as the DLRL) and focused on the potential for
risk reduction, cost-benefit balancing and other relevant factors,
establishing the standards at 40 [micro]g/ft\2\ and 250 [micro]g/ft\2\
for floors and sills, respectively. The Agency did not establish a DLHS
(described moving forward as the DLRL) for troughs as it found that
window sills and troughs were highly correlated and concluded that
testing both surfaces would not improve a risk assessor's ability to
characterize risk.
Building off the precedent established in 2001, the 2019 Final Rule
``evaluated the relationship between dust-lead levels and children's
health, and . . . the application of those standards in lead risk
reduction programs.'' In addition, when establishing the 2019
standards, EPA also assessed laboratory capabilities, resources for
addressing LBP hazards and consistency across the Federal government
(Ref. 2). At that time EPA reasonably believed it had the discretion to
set the DLHS (described as DLRL moving forward) based on both risk
reduction and whether the standards were achievable, especially given
the existing programs in place to reduce LBP hazards and revised the
standards to 10 [micro]g/ft\2\ and 100 [micro]g/ft\2\ for floors and
sills, respectively (Ref. 2).
Ultimately, the 2021 Court Opinion, which is discussed in Unit
II.E., led EPA to undertake a major shift in its approach to
residential LBP hazard control and the LBP activities program because
the Court found that EPA did not have the authority, when setting the
DLHS, to consider non-health factors (e.g., laboratory capabilities,
resources for addressing LBP hazards, consistency across the Federal
government, or cost-benefit balancing). Consistent with the 2021 Court
Opinion, EPA proposed revisions to the DLHS (described as DLRL moving
forward) in August 2023 and is finalizing those changes in this
rulemaking based only on health considerations (Ref. 55). EPA intends
health-only considerations in this context to refer to the effects of
lead on health after exposure to dust-lead loadings, considering the
statutory definition's focus on ``any condition that causes exposure to
lead from lead-contaminated dust . . . that would result in adverse
human health effects'' (15 U.S.C. 2681(10)). These health-only
considerations do not include broader public health concerns (such as
health trade-offs and policy impacts on Federally assisted housing).
See Unit IV.B.1.d. for more discussion on public health considerations
and public feedback.
1. Rationale for Selecting the Final DLRL
EPA is finalizing a non-static DLRL that is any reportable level of
dust-lead for floors and window sills as analyzed by an NLLAP-
recognized laboratory. Setting a DLRL for floors and window sills only
is consistent with current practice and regulatory history, which has
not included a hazard standard or reportable level specifically for
troughs.
Given the statutory language in TSCA section 401 that defines what
a ``LBP hazard'' is (i.e., as conditions of LBP and lead-contaminated
dust and soil that ``would result in adverse human health effects''),
EPA believes that it cannot set the DLRL at zero because zero exposure
to dust-lead loadings would not cause adverse health effects. EPA is
not attempting to establish a safe level of dust-lead as, at this time,
no BLL threshold at which no adverse effects occur in children has been
identified (Ref. 5, 56), and EPA did not identify a level of dust-lead
exposure at which there is no effect on BLL. The standard being
established--``any reportable level''--is an appropriate non-zero DLRL
and is based on dust-lead related health factors only. It was developed
in accordance with the 2021 Court Opinion by taking into consideration
the exposure modeling data outlined in TSD and the current state of the
science on the health effects of lead exposure. The final DLRL approach
represents a shift in the LBP activities program to a more inclusive
and protective standard, compared with the 2019 levels. The DLRL
approach will be inclusive of any reportable level of dust-lead and
will not distinguish based on health risk posed.
EPA received public comments on the ``any reportable level''
approach to the DLRL, which are discussed in more depth in Unit
IV.B.1.d. Additionally, two other approaches were also considered for
revising the DLRL, including a numeric standard based entirely on the
modeling data laid out in the TSD (summarized in TSD table 2-2), and an
approach that would use the background dust-lead levels of housing
built in or after 1978 (called post-1977 background); both are briefly
discussed in Unit IV.B.2.
a. DLRL and the LQSR Action Level
The DLRL is being finalized as any reportable level as analyzed by
an NLLAP-accredited laboratory. ``Reportable level'' had not previously
been defined in EPA's regulations at 40 CFR part 745 or EPA's current
guidance for NLLAP-recognized laboratories, titled Laboratory Quality
Standards for Recognition (or LQSR 4.0). EPA is finalizing the
definition of ``reportable level'' as proposed to mean the lowest
analyte concentration (or amount) that does not contain a ``less than''
qualifier and that is reported with confidence for a specific method by
an NLLAP-recognized laboratory. In other words, EPA interprets ``any
reportable level'' of dust-lead to be any level greater than or equal
to the lowest value a laboratory can reliably report to a client or the
regulated community, and a report of zero concentration is not
permitted under the LQSR. For target housing or a COF to achieve no
dust-lead hazard, an NLLAP-recognized laboratory would need to provide
a result that was less than (<) their reporting limit. Any numeric
value that is above an NLLAP-recognized laboratory's reporting limit
would be considered a dust-lead hazard and would need to be disclosed
as such, for example, on a risk assessment report prepared by a
certified risk assessor.
In terms of the standards being finalized in this rule and their
impact on laboratories, given that the DLRL is a non-static value, the
DLAL, rather than the DLRL, would be considered the ``action level'' as
described in the LQSR 4.0, as well as for when a risk assessor would
recommend an abatement (see Unit IV.E. for more information on EPA's
revisions to the definition of abatement). Under the LQSR 4.0, NLLAP-
recognized laboratories that analyze dust wipe samples for lead must
show that they can achieve a quantitation limit ``equal to or less than
. . . 80% of the lowest action level [i.e., regulatory limit] for dust
wipe samples''; this is a shift from LQSR 3.0 where it was 50% (Refs.
26 and 57). The quantitation limit must also be ``at least 1.6 times
but no greater than 10 times the method detection limit'' (Ref. 26).
Thus, EPA's minimum standards for testing will rely on the numerical
DLAL of 5 [mu]g/ft\2\, 40 [mu]g/ft\2\, and 100 [mu]g/ft\2\ for floors,
window sills and window troughs to establish the quantitation limit
that any laboratory (that wishes to maintain or obtain NLLAP
recognition) must be able to demonstrate (Ref. 26). The DLRL of ``any
reportable level'' is considered distinct from the DLAL and not to
affect the quantitation limit under the LQSR. Based on these minimum
[[Page 89429]]
standards for NLLAP-recognized laboratories and previous laboratory
stakeholder input, EPA expects that the lowest reportable level will be
equivalent to the laboratory's quantitation limit. Note that only
laboratories that are NLLAP accredited can perform dust-wipe testing
for lead under the existing regulations at 40 CFR part 745.
EPA received public comments raising concerns that the DLRL is non-
static and would change among laboratories depending given technology
sensitivity, conditions etc. Commenters, including an NLLAP accrediting
body, requested that the area wiped, instrumentation and/or method
detection limit be defined to provide more consistency. EPA fully
acknowledges that the reportable level under the final DLRL will
potentially vary from laboratory to laboratory due to different
capabilities. EPA believes establishing a DLRL based on the
capabilities of individual laboratories is a strength of the final DLRL
because it allows room for improvement and the possibility of getting
as low as reliably reportable depending on the sensitivity of the
technology--in turn allowing the regulated community to be able to
disclose lower levels. This will also limit the need for future
revisions to the DLRL, unless there is a compelling reason to, such as
a threshold for adverse effects being identified. Note that the trigger
for the recommendation of work has been shifted to the DLAL (rather
than the DLHS, described as DLRL moving forward, as has been the case
historically). See Unit IV.F. for more information on the change to the
definition of abatement.
While EPA understands the request for some form of minimum
laboratory requirements, EPA disfavors requiring laboratories to use a
specific type of technology for analysis, as that will limit some
laboratories who have or would like to have more sensitive
capabilities. Note that EPA does include standards that act as an upper
bound within EPA's LQSR 4.0 as discussed previously (e.g., every
laboratory must have a quantitation limit equal to or less than 80% of
the action level for each surface of interest, such as floors, window
sills and troughs), among other standards, which effectively function
to promote consistency between laboratories. For dust-wipe testing of
floors, EPA does recommend that LBP professionals wipe at least two
square feet as needed to help the NLLAP-recognized laboratory achieve
the LQSR's standard for the quantitation limit. Similarly, HUD already
recommends using at least two square feet for LBP professionals
conducting dust-lead testing of floors (in circumstances where needed
for laboratory capabilities) for HUD's current dust-lead action levels
for its Lead Hazard Reduction grant programs (Ref. 58). EPA also
recommends that LBP professionals document the sample size in order to
inform the NLLAP-recognized laboratory either through already
established practices or the Chain of Custody form. EPA does note that
there may be laboratories with more sensitive technology that can meet
the LQSR minimum standards without testing two square feet on floors.
Overall EPA disagrees that the types of specifications requested by
some commenters are required for the DLRL to work as intended. EPA
recommends, if there are concerns, that the regulated community work
directly with laboratories. Understanding the laboratory's reporting
limits and attaining consistent levels across larger projects is
possible for the regulated community through contracts (i.e.,
arrangements incorporated into the project to use either the same
laboratory or those with the same reporting values and technology), and
through understanding various laboratories' reporting limits. EPA
acknowledges the potential challenges of inconsistency that may arise
from the final DLRL, but EPA does not believe this can be considered
when setting the DLRL or that it outweighs the benefit of additional
disclosures to the public that will result from this approach.
b. No Threshold Has Been Identified
According to TSCA Title IV, EPA should identify the level of dust-
lead exposure that ``would result in adverse human health effects'' as
a type of LBP hazard (15 U.S.C. 2681(10)). Any reportable level of lead
in dust is a more protective approach compared with the current
regulatory landscape. Any reportable level of lead in dust also
acknowledges the current state of scientific evidence. Based on the
epidemiological evidence available, EPA observed in the 2013 and 2024
Integrated Science Assessments that there is no evidence of a threshold
below which there are no harmful effects on cognition from lead
exposure (Refs. 5 and 56). Depending on the exposure and other factors,
effects on IQ associated with childhood lead exposure may persist into
adolescence and adulthood (Refs. 5 and 6). EPA also favored such an
approach for the DLRL under TSCA Title IV in part because a more
protective approach to DLRL, such as any reportable level, aligns with
the Congressional purpose for disclosure elsewhere under Title X
(notably, as implemented in the Lead Disclosure Rule) and because
Congress used the word ``hazard'' in the ``lead-based paint hazard''
term, even though the definition uses more risk-like language by
introducing consideration of the level of exposure that would result in
adverse health effects.
The EPA 2024 Lead ISA stated that effects of lead exposure on
children's cognition were best substantiated to occur in study
populations with mean BLLs between 2 and 8 [micro]g/dL and noted that,
extending the evidence described in the 2013 Lead ISA, associations
with effects on cognition were also observed in groups with mean BLLs
below 2 [micro]g/dL (though not all studies with mean BLL below 2
[micro]g/dL reported positive associations between BLL and IQ
decrements). Further, despite there being some uncertainty in
epidemiological studies on lead exposure and BLLs (especially for older
children and adults), the 2024 ISA stated that ``the collective body of
epidemiologic studies provides no evidence of a threshold for cognitive
effects in children across the range of BLLs examined.'' This body of
evidence includes studies which found effects on children's cognition
in some groups of children with prenatal and early childhood blood lead
or concurrent blood lead in the range of <1 to 10 [mu]g/dL. (Ref. 5).
This statement was based on a synthesis of the extensive literature
examining the relationship between BLL and cognitive function,
including a landmark pooled cohort study by Lanphear et al. (Refs. 59
and 60), the results of which have been confirmed by repeated re-
analysis (Refs. 61 and 62). The 2024 ISA's statement on a threshold for
cognitive function decrements in children is consistent with the 2013
ISA (Refs. 5 and 56), despite the evaluation of over 10 years of
additional scientific evidence. The Federal Lead Action Plan, developed
by the President's Task Force on Environmental Health Risks and Safety
Risks to Children, which is comprised of 17 Federal departments and
offices, states that ``no safe blood lead level in children has been
identified.'' (Ref. 7). Further, the analysis that supports this rule
examined the 95th percentile of children's modeled BLLs and the
associated IQ losses (Ref. 12), which for all options considered is at
or above the group mean BLLs for which IQ loss is observed in the
literature examined in the ISA (Ref. 5 and 12).
EPA understands the limitations of the epidemiological analyses of
BLL and children's IQ and the heterogeneity observed in scientific
studies evaluating
[[Page 89430]]
groups with mean BLLs below 2 [micro]g/dL, and acknowledges that a
threshold could exist that is currently unidentified; but ultimately in
its assessment of the available scientific research findings in the
2024 ISA for lead, the Agency observed that ``the collective body of
epidemiologic studies provides no evidence of a threshold for cognitive
effects in children across the range of BLLs examined.'' This body of
evidence includes studies which found effects on children's cognition
in some groups of children with prenatal and early childhood blood lead
or concurrent blood lead in the range of <1 to 10 [mu]g/dL (Ref. 5).
EPA continues to acknowledge the aforementioned uncertainties and notes
that science is constantly evolving and, as additional data become
available (e.g., exposure and health impacts), then EPA may undertake a
new rulemaking to propose changing the standards in the future to
reflect any new data or information about an acceptable threshold of
effects on cognition in children.
Additionally, the CDC acknowledges that ``[s]cientific evidence
suggests that there is no known safe [BLL], because even small amounts
of lead can be harmful to a child's developing brain'' (Ref. 63). When
the original DLHS and DLCL were proposed and finalized in 1998 and 2001
the CDC had set a ``level of concern'' for children's BLL at >=10
[micro]g/dL (Refs. 64 and 65). In 1991, when that level was established
as a level that should prompt public health actions, the CDC
concurrently recognized that a BLL of 10 [micro]g/dL did not define a
threshold for the harmful effects of lead (Ref. 64). One goal for the
level was that ``all lead poisoning prevention activities should be to
reduce children's BLLs below 10 [micro]g/dL'' (Ref. 64). Accordingly,
in the 1998 proposal EPA stated that, ``[a]lthough the scientific
community has not been able to identify a threshold of exposure below
which adverse health effects do not occur, the evidence of health
effects below 10 [micro]g/dL is not sufficiently strong to warrant
concern'' (Ref. 66). In the final rule in 2001, EPA determined the
lowest candidate DLHS by using a 1 to 5% probability of an individual
child developing a BLL of 10 [mu]g/dL (Ref. 20).
In the 2019 Final Rule, EPA recognized that ``[a]lthough health
risks to young children decrease with decreasing dust-lead levels, no
non-zero lead level, including background levels, can be shown to
eliminate health risk entirely.'' At that time, EPA also recognized the
CDC's 2012 decision to discontinue its use of a 10 [micro]g/dL blood
lead ``level of concern'' and to introduce a population-based blood
lead reference value (BLRV) to identify children exposed to more lead
than most other children in the United States (Ref. 67). The BLRV
represents the 97.5th percentile of the U.S. population BLL
distribution in children ages 1 to 5 from the National Health and
Nutrition Examination Surveys (NHANES). This means that by definition
2.5 percent of children ages 1 to 5 in the NHANES survey have a BLL
greater than the BLRV. This metric was established in part because ``no
safe blood lead level in children ha[d] been identified,'' (Ref. 67).
In 2012 the BLRV was 5 [micro]g/dL, based on young children's BLL in
the 2007-2010 NHANES, and in 2021 it was lowered to 3.5 [micro]g/dL
based on the children's lower BLLs observed in the 2015-2018 NHANES
(Ref. 65). The BLRV is not based on a health endpoint, but rather is a
statistical point in the distribution of children's BLLs in the United
States used as a policy tool to identify children who have higher
levels of lead in their blood compared with most children.
Establishing a health-based only standard for DLRL, as well as DLAL
that considers other factors (i.e., taking into account reliability,
effectiveness, and safety), is similar to EPA's implementation of some
other programs governing lead exposure. For example, under the Safe
Drinking Water Act (SDWA), EPA is required to establish a maximum
contaminant level goal (MCLG) at a level at which, in the
Administrator's judgment, ``no known or anticipated adverse effects on
the health of persons occur and which allows an adequate margin of
safety.'' SDWA section 1412(b)(4). EPA established a health based MCLG
of zero for lead in drinking water. National Primary Drinking Water
Regulations include either an enforceable maximum contaminant level
(MCL) or treatment technique requirements, EPA can set a treatment
technique requirement in lieu of an MCL if ``it is not economically or
technologically feasible to ascertain the level of the contaminant.''
SDWA section 1412(b)(7)(A). In addition to the MCLG, EPA established
treatment technique requirements for lead taking into account several
factors (56 FR 26460). Unlike many other drinking water contaminants,
lead is generally not present in source water but enters drinking water
from corrosion of plumbing materials that contain lead including lead
service lines and premise plumbing. Occurrence of lead in drinking
water is variable within a system and across systems due to factors
such as the amount of lead in any individual site's plumbing, physical
and chemical characteristics of the water, and consumer use patterns.
Additionally, sources of lead can be beyond the control of the water
system to replace, such as premise plumbing. Water systems can adjust
or add treatment to control the corrosivity of the water to reduce lead
leaching from lead pipes and premise plumbing. EPA is required to
consider technical feasibility and costs when establishing the
treatment technique. Under EPA's treatment technique rule for lead in
drinking water, EPA established a non-health-based action level that,
if exceeded, requires water systems to take actions to reduce elevated
levels of lead in drinking water.
c. Modeling Discussion and Results
The Technical Support Document estimated BLL and IQ decrements
(among other health endpoints, see Unit III. for more information) in
children exposed to hypothetical dust-lead loading values (i.e., it
evaluated the estimated impacts of exact dust-lead exposures). These
estimates for BLLs of children exposed to the DLRL dust-lead loadings
were evaluated for children at each age up to age six, including age
two (generally, age two is the age of greatest modeled exposure), and
lead-related reduction in IQ at age six was estimated from the lifetime
average BLL (average of BLLs across the period prior to age six). This
approach is consistent with the study from which the BLL concentration-
IQ response function was drawn. This study related IQ quantified at
about six years of age to each child's lifetime average BLLs (based on
blood lead measurements taken from six months up to age of the IQ test
(Refs. 59 and 60). In the following discussion towards the end of this
section, both the model results for two-year BLL and the estimates of
IQ change at six years are represented, and EPA refers to them as the
results for ``young children'' for brevity.
Ultimately, the results from the TSD show that as dust-lead levels
in housing decrease below the current standard (i.e., 10 [micro]g/ft\2\
and 100 [micro]g/ft\2\ for floors and window sills), so do children's
BLL and IQ decrement from lead exposure, which supports the final
approach of any reportable level and the concept of disclosure. These
values are estimated to help EPA analyze the impacts of this rulemaking
on the health (i.e., IQ decrement, which is a measure of cognitive
function) and dust-lead exposure of the population in question (i.e.,
young children in pre-1978 buildings and COFs), as well as to inform a
costs and benefits analysis in the EA. Two other approaches to
[[Page 89431]]
revising the DLHS (described as DLRL moving forward) and their dust-
lead loading candidates were considered and were both discussed in
depth in the 2023 Proposed Rule and evaluated in the TSD. See Unit
IV.B.2. for more information.
When choosing health or exposure metrics to evaluate the DLRL
approaches based on the TSD results, the Agency considered three
factors: (1) the CDC's BLRV (which is a not a health-based end point
but rather is a statistical measure of relative exposure); (2)
responsiveness to feedback received previously from various scientific
bodies; and (3) Agency precedent. The TSD considers BLL and IQ changes
in two ways: relative to aggregate/total lead exposure (which includes
exposure from other media: soil, diet, water, and air in addition to
dust) and relative to incremental/dust-only lead exposure (Ref. 12).
For example, in 2001 the lowest DLHS candidate was identified by using
a 1 to 5% probability of an individual child developing a BLL of 10
[mu]g/dL (Ref. 20), which represented total BLL, inclusive of exposure
to lead through other media.
In the TSD analyses for this final rule, EPA compared BLL in young
children, with an emphasis on 2-year-old children because this is the
age of greatest modeled exposure, from aggregate or total exposure from
all media (i.e., dust, soil, diet, water, and air) to the CDC BLRV of
3.5 [mu]g/dL. This BLL value is not health based and does not represent
a toxicity threshold (and is subject to change over time, since the CDC
BLRV changes as the BLLs in the population change); however, CDC
explains that it can still be used as a tool to ``(1) help determine
whether medical or environmental follow-up actions should be initiated
for an individual child and (2) prioritize communities with the most
need for primary prevention of exposure and evaluate the effectiveness
of prevention efforts'' (Ref. 65). Importantly, even at zero dust-lead
(which again is not a candidate of interest but is being used for
comparison and informational purposes only), children are estimated to
have a 5.7% probability of exceeding the BLRV given the impact of
background lead exposures from other media (e.g., soil, diet, water,
and air) (Ref. 12).
Table 1--Percent Exceedance Values for Zero Dust-Lead, Age: 2-Year-Old (30 Months)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Probability
-------------------------------------------------------------------
Approach Floor ([micro]g/ Sill ([micro]g/ Dust only BLL Dust only BLL
ft[sup2]) ft[sup2]) Total BLL >3.5 Total BLL >5 >1 [micro]g/dL >2.5 [micro]g/
[micro]g/dL (%) [micro]g/dL (%) (%) dL (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Zero \1\.......................................... 0 0 5.7 2.2 0.0 0.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The exceedance values for zero dust-lead are provided for comparison with the DLRL candidates; it is not a candidate value and is for informational
purposes only.
In 2011, EPA's Scientific Advisory Board (SAB) and in 2012 the
Children's Health Protection Advisory Committee (CHPAC) both expressed
support for an incremental BLL approach that focuses on dust-lead
exposure only. In 2011 SAB reviewed EPA's Approach for Developing Lead
Dust Hazard Standards for Residences (November 2010 Draft) and Approach
for Developing Lead Dust Hazard Standards for Public and Commercial
Buildings (November 2010 Draft) and provided feedback that there are
several key advantages to the incremental approach (e.g., reducing
uncertainty from estimating exposures from other media) and provided
that a change in BLL ``of 1 or 2 [mu]g/dL at the 90th percentile''
could be an example of a target risk level. Similarly, CHPAC expressed
support for using an incremental approach and preferred levels such
that an adverse change in BLL is ``no greater than 1 or 2.5 [micro]g/
dL'' (Ref. 68).
As a result, EPA also estimated what dust-lead levels (considering
only the dust-lead component in the multi-media exposure modeling)
would result in incremental BLL change ranging between 1 and 2.5 [mu]g/
dL based on exposure assumptions described in the TSD (Ref. 12).
For this reconsideration rulemaking the Agency considered the
estimated total/aggregate IQ change (i.e., the estimated total or
aggregate IQ change from modeled BLL including all modeled sources of
lead exposure) at age six and compared it to a threshold of 1 to 2
points. IQ changes due to background exposures to lead in other media
(e.g., soil, diet, water, and air) are estimated to already have a
48.7% probability to exceed 2 points for children in target housing
without also considering additional dust-lead exposure (Ref. 12).
Table 2--Percent Exceedance Values for Zero Dust-Lead, Age: 6-Year-Old (72 Months)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Probability
-------------------------------------------------------------------
Approach Floor ([micro]g/ Sill ([micro]g/ Total IQ Total IQ Dust only IQ Dust only IQ
ft[sup2]) ft[sup2]) decrement >1pt decrement >2pt decrement >1pt decrement >2pt
(%) (%) (%) (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Zero \1\.......................................... 0 0 88.9 48.7 0.0 0.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The exceedance values for zero dust-lead are provided for comparison with the DLRL candidates; it is not a candidate value and is for informational
purposes only.
In addition to total/aggregate IQ change, EPA determined BLLs that
were estimated to result in an incremental loss of 1 to 2 IQ points
from exposure to only dust-lead (i.e., exclusive of lead in other media
such as soil, diet, water, and air). This metric is explicitly health-
based, in that it is an estimated health effect. There is EPA
precedence for using the metric of an incremental change in IQ with a
range of values of 1 to 2 points to inform national standards
decisions. This includes the 2008 and 2016 decisions on the primary
national ambient air quality standard (NAAQS) for lead, which was
informed by consideration of air-related IQ decrement estimates based
on an evidence-based framework, with a focus on the at-risk
subpopulation of children living near sources who are likely to be
[[Page 89432]]
most highly exposed to air-related lead (Ref. 69). In their review of
various technical documents supporting both the 2008 and 2016 NAAQS
reviews, the Clean Air Scientific Advisory Committee (CASAC) supported
using an incremental 1-to-2-point IQ decrement approach for
consideration during development of the air standard (Refs. 69 and 70).
When modeling the ``any reportable level'' approach in the TSD to
compare to these health and exposure metrics of interest (as discussed
previously), EPA used estimated dust-lead loadings ranging from 0.8 to
2.0 [micro]g/ft\2\ for floors and 0.8 to 4.3 [micro]g/ft\2\ for window
sills. These are estimated values for an any reportable level DLRL
paired with both the proposed DLAL (3 [mu]g/ft\2\, 20 [mu]g/ft\2\, and
25 [mu]g/ft\2\ for floors, window sills, and window troughs
respectively) and the proposed alternative DLAL (5 [mu]g/ft\2\, 40
[mu]g/ft\2\, and 100 [mu]g/ft\2\ for floors, window sills and window
troughs respectively, which is being finalized in this rulemaking).
These estimated dust-lead loadings account for the lower reporting
thresholds that EPA estimates laboratories will realistically attain
under this rule. EPA collected information on real-world laboratory
reporting limits from stakeholder outreach conversations. These any
reportable level values listed in this unit are based on the average of
reporting limits (which can vary across laboratories) that currently
report numeric dust wipe loadings at levels 80% of the DLAL options.
For the details of these calculations, see Section 2.4.6 of the EA
(Ref. 10). Once again, EPA also used a hypothetical dust-lead loading
value of zero, for comparison purposes only, to better understand the
estimated impact that lead exposure from other matrices is expected to
have on a young child without any dust-lead exposure.
The dust-lead reportable level will be used as a tool to identify
when there are LBP hazards, particularly dust-lead hazards present, and
to disclose those hazards to the individuals who requested the work.
EPA's analysis for the final DLRL (any reportable level partnered with
the final DLAL of 5 [mu]g/ft2 and 40 [mu]g/ft2 for floors and window
sills) shows that after implementation of this standard, young children
in target housing are estimated to have a 9.8% probability of exceeding
an incremental BLL of 1 [mu]g/dL (tables 12-2 and 12-3 in the TSD). In
contrast, under the 2019 DLHS of 10 [mu]g/ft2 and 100 [mu]g/ft2, such
children would have a 36.7% probability of exceeding that BLL.
When evaluating the final DLRL of any reportable level partnered
with the final DLAL of 5 [mu]g/ft\2\ and 40 [mu]g/ft\2\ for floors and
window sills by its impact on the metric of total BLL, the modeling
includes exposure from other media such as soil, diet, water, and air.
Importantly, even at zero dust-lead, 2-year-old children in target
housing are estimated to have a 5.7% probability of exceeding the BLRV
given the impact of these other exposures. This is because children who
reside in target housing (built before 1978) have higher exposures to
lead in soil and water relative to the overall population of US
children (Ref. 71). However, the TSD modeling results did show that for
any reportable level approach partnered with the final DLAL, there was
a 10% probability of exposed 2-year-old children's BLL exceeding the
CDC BLRV given their likely exposures to other sources of lead, an
increase of 4.3% from the 5.7% probability at zero dust-lead and a
reduction from the 2019 DLHS levels of 18%.
Table 3--Percent Exceedance Values for DLRL Candidates, Age: 2-Year-Old (30 Months)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Probability
Floor ---------------------------------------------------------------
Approach ([micro]g/ Sill ([micro]g/ Total BLL >3.5 Total BLL >5 Dust only BLL Dust only BLL
ft[sup2]) ft[sup2]) [micro]g/dL [micro]g/dL >1 [micro]g/dL >2.5 [micro]g/
(%) (%) (%) dL (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Zero \1\................................................ 0 0 5.7 2.2 0.0 0.0
ARL With 3/20 DLAL...................................... 0.8 0.8 8.4 3.0 4.2 0.2
ARL With 5/40 DLAL...................................... 2.0 4.3 10.0 3.8 9.8 0.9
Current Standard........................................ 10 100 18.0 7.5 36.7 6.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The exceedance values for zero dust-lead are provided for comparison with the DLRL candidates; it is not a candidate value and is for informational
purposes only.
DLRL candidates with the any reportable level approach are also
estimated to be associated with a considerable reduction in the percent
exceedance values for the lowest IQ decrements when compared with the
current DLHS of 10/100 [mu]g/ft\2\ for floors and window sills. Any
reportable level partnered with the final DLAL option (5 [mu]g/ft\2\,
40 [mu]g/ft\2\) is estimated to have an 8.4% probability of greater
than 2 points of IQ decrement associated with dust-exposure, keeping
the percentage of exceedance of 2 points of IQ decrement below 10%
probability compared with the previous 2019 DLHS of 37.9%.
Table 4--Percent Exceedance Values for DLHS Candidates, Age: 6-Year-Old (72 Months)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Probability
Floor ---------------------------------------------------------------
Approach ([micro]g/ Sill ([micro]g/ Total IQ Total IQ Dust only IQ Dust only IQ
ft[sup2]) ft[sup2]) decrement >1pt decrement >2pt decrement >1pt decrement >2pt
(%) (%) (%) (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Zero \1\................................................ 0 0 88.9 48.7 0.0 0.0
ARL With 3/20 DLAL...................................... 0.8 0.8 96.4 71.0 20.3 2.7
ARL With 5/40 DLAL...................................... 2.0 4.3 97.7 78.0 39.2 8.4
Current Standard........................................ 10 100 99.4 90.3 75.8 37.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The exceedance values for zero dust-lead are provided for comparison with the DLRL candidates; it is not a candidate value and is for informational
purposes only.
[[Page 89433]]
d. Public Comment Input
EPA received a number of comments during the public comment period
that supported the proposed DLHS approach (described as DLRL moving
forward) of ``any reportable level'' based on their view that there is
no safe level of lead exposure. Multiple commenters also emphasized the
dangers of lead exposure and were supportive as the DLRL will make the
public and the regulated community aware of the risk lead dust may
pose. Comments were also received expressing a lack of support for any
reportable level, highlighting several primary concerns: that this
approach would lead to larger public health impacts, create housing
instability, encompass background levels of lead or lead sources that
are not from lead-based paint, that the level would vary or be
inconsistent from laboratory to laboratory, concerns over liability,
and the impacts that an increase in costs would have.
EPA's responsibility when revising the DLRL (which is being done in
accordance with the May 2021 Court Opinion and EPA's statutory
authority) is to identify ``any condition that causes exposure to lead
from lead-contaminated dust . . . that would result in adverse human
health effects'' (emphasis added) (15 U.S.C. 2681(10)). These health-
only considerations do not include broader public health concerns and
are specifically focused on the health impacts of dust-lead exposure,
without consideration of housing instability, source of the lead in the
dust, cost, etc. In 2019 when EPA originally revised the DLHS, the
Agency did so based on other factors such as risk management,
consistency across the U.S. government, and laboratory capacity and
capability, among other reasons. The 2021 Court opinion clearly
explained that EPA must reconsider the 2019 DLHS and do so using
health-only factors.
Firstly, EPA agrees with public commenters about the importance of
the availability of affordable housing in the United States and wants
to highlight actions this Administration has taken on this issue, such
as the May 2022 Housing Supply Action Plan which was last updated in
July 2023 with actions to further lower housing costs and boost supply
(Refs. 72 and 73). Access to secure housing is an important social
determinant of health (Ref. 74). Research finds negative health effects
resulting from three key mechanisms of housing insecurity: lack of
housing affordability leading to stress and material deprivation (Refs.
75, 76, 77 and 78), lack of housing stability (Refs. 79, 80, 81, 82 and
83), and lack of safe and adequate housing (Refs. 84, 85, 86, 87 and
88). EPA does not want to negatively impact the availability of housing
stock with this final rulemaking nor disincentivize participation in
any Federal programs and plans to work closely with HUD to try to help
mitigate any such consequences. See Unit V.B. for more information on
the implications of this rulemaking on HUD programs.
Secondly, EPA acknowledges that lead is naturally occurring and
that it is impossible to entirely remove lead from nature. EPA
acknowledges that background concentrations of dust-lead could be
higher than any reportable level as analyzed by an NLLAP-recognized
laboratory, depending on the sensitivity of the dust-wipe sampling
technology being used and the background levels themselves. However, in
EPA's 2001 LBP Hazards Rule establishing the original dust-lead
standards, including the DLHS and DLCL (described as DLRL and DLAL
moving forward), EPA explained that the Agency would not exclude from
coverage under TSCA Title IV certain dust or soil based on its lead
source due to both statutory and technical reasons. The 2001 Response
to Comment Document (that accompanies the 2001 LBP Hazards Rule)
rightly pointed out that the definitions of ``lead-contaminated soil''
and ``lead-contaminated dust'' from TSCA section 401 do not include
mention of lead-paint or any reference to paint as the source of lead
in dust or soil. Additionally, the definition of a ``lead-based paint
hazard'' lists exposure to lead from lead-contaminated dust and soil as
sources of lead contamination separate from--and not explicitly linked
to--lead-contaminated paint. The 2001 Response to Comment Document
continues that in addition to soil, paint and dust being defined
separately and distinctly in the statute, TSCA section 403 directs EPA
to ``promulgate regulations which shall identify, for the purposes of
[TSCA Title IV] and the Residential Lead-Based Paint Hazard Reduction
Act of 1992, lead-based paint hazards, lead-contaminated dust, and
lead-contaminated soil'' (15 U.S.C. 2683). If the definitions for lead-
contaminated dust and soil were meant to include only lead from paint,
it would not be necessary to list them separately in TSCA section 403.
EPA ultimately concluded, based on the ``breadth of the definition for
lead-contaminated dust and soil taken together with the structures of
both Title X and TSCA demonstrate that the lead source in lead-
contaminated dust and soil covered by these statutes is not limited to
lead from paint.'' For the full discussion, see the 2001 response to
comments document (Ref. 89).
Separately, EPA also pointed out in the 2001 response to comments
document the complexity of identifying a method for distinguishing the
risks based on different types of lead (i.e., from different sources).
It is not possible to determine easily and with good precision what
element of lead in dust or soil is from what specific source or
building component. EPA concluded at the time that ``there is a
distinct absence of a scientific method to determine conclusively that
the source of lead in dust or soil is not paint on a routine basis.''
EPA believes that this conclusion has not changed, and while there are
some studies that involve stable isotope ratios (see 2001 response to
comments document for more information), those are not a viable
solution for the LBP activities program which includes numerous
properties that fall under the definition of target housing and COFs,
with risk assessments and testing happening across the United States on
a routine basis.
Note that the U.S. Court of Appeals for the District of Columbia
Circuit upheld this interpretation pertaining to source apportionment
in 2002 in Nat'l Multi Housing Council v. EPA, 292 F.3d 232 (D.C. Cir.
2002). Based on the epidemiological evidence available, EPA observed in
the 2013 and 2024 Integrated Science Assessments that there is no
evidence of a threshold below which there are no harmful effects on
cognition from lead exposure, (Refs. 5 and 56), and that conclusion is
not impacted by the source of that lead exposure. EPA is also unaware
of any information that points to different health effects based on
different types of dust-lead (i.e., dust-lead from soil vs. dust-lead
from household paint).
Thirdly, EPA agrees with the commenters that the final DLRL
(previously referred to as DLHS) will potentially vary from laboratory
to laboratory. EPA sees this as a strength of the final DLRL: that
there is room for improvement and the possibility of getting as low as
reliably reportable depending on the sensitivity of the technology,
which in turn allows the regulated community to be able to disclose
lower levels. In addition, EPA sets the minimum standards laboratories
need to meet, outlined in the latest LQSR version 4.0. Therefore, EPA
feels the potential for variability that the commenters are raising is
limited and any variability would be below the 80%
[[Page 89434]]
of the lowest action level for dust wipe samples per specific surface
area (i.e., equal to or less than 4 [micro]g/ft\2\ for floors, 32
[micro]g/ft\2\ for window sills and 80 [micro]g/ft\2\ for troughs).
This will also reduce the need to revise the DLRL, unless there is a
compelling reason to, such as a threshold for adverse effects being
identified. EPA also notes that it has previously adopted and continues
to apply an analogous concept in the disclosure program (40 CFR part
745, subpart F and 24 CFR part 35, subpart A), where disclosable
records and reports have included any information regarding LBP or LBP
hazards, including dust-lead levels below the DLHS (described as DLRL
moving forward). As laboratory testing protocols have improved, so has
the quality of the information in the records and reports based on such
testing, which are ultimately provided to the home/building owner or
lessee.
EPA points the regulated community to other changes being finalized
in the rulemaking, such as the definition of abatement and the
nomenclature change, which will adjust the terminology used for the
standards. EPA is finalizing a change in the definition of abatement
that results in the recommendation for action being shifted to the DLAL
(rather than the DLHS, described as DLRL moving forward, as has been
the case historically). The DLAL is being finalized as 5 [micro]g/
ft\2\, 40 [micro]g/ft\2\ and 100 [micro]g/ft\2\ for floors, window
sills, and window troughs. EPA also recommends that all local, Federal
and authorized programs make similar changes, to change their trigger
for recommending action, for the same reasons EPA has explained that
this rulemaking adopts such changes. EPA believes this change will also
alleviate some of the concerns surrounding laboratory inconsistency if
the recommendation for action hinges off of the DLAL rather than the
DLRL. See Unit IV.A. and Unit IV.E. for more information on these
amendments.
Additionally, due to feedback from public comments (see Section 5
of the response to comments document that accompanies this final rule
for more information), EPA is also finalizing changes to the
nomenclature of DLHS and DLCL, to dust-lead reportable level and dust-
lead action level (abbreviated DLRL and DLAL). EPA believes these
revisions will better communicate to the public the purpose of the
standards and to reduce confusion. EPA believes these changes will also
help address some of the commenters' concerns about potential liability
for LBP professionals or landlords from allowing dust-lead hazards to
remain.
A more comprehensive version of EPA's responses on all of these
issues can be found in the response to comments document that
accompanies this rulemaking (Ref. 38).
2. Other Approaches EPA Considered in the Proposed Rule
EPA considered two other approaches for revising the DLHS
(described as DLRL moving forward): a ``numeric standard'' approach and
a ``post-1977 background'' approach. Both approaches were discussed in
depth in the proposed rule, which also included requests for comment.
All three approaches (i.e., any reportable level, numeric standard, and
post-1977 background) would take different analytical paths to revising
the DLRL based only on health considerations. EPA is finalizing any
reportable level, see Unit IV.B.1. for more information; however, the
other two approaches EPA considered are summarized briefly elsewhere in
this unit (Unit.IV.B.2.). See the 2023 Proposed Rule for more detailed
information (Ref. 55).
The ``numeric standard'' approach would have been based on the
probability of exceedance of one or more IQ or BLL metrics as
determined by the Agency, meaning that the Agency would establish a
DLRL with a rationale based solely on the interpretation of the TSD
results and using a selected metric. To do this, the Agency would need
to establish a health or exposure metric of interest (i.e., target BLL
or IQ change) that would be acceptably protective of human health, such
as the metrics used in the TSD and described in Unit IV.B.1.c. Within
the TSD and for the 2023 Proposed Rule, EPA evaluated several numeric
DLRL candidates that the Agency thought were appropriate given the
health and exposure metrics of interest and the uncertainty of the
model at low loading values. The numeric DLRL candidates discussed in
the proposed rule were 1/10 [mu]g/ft\2\ (i.e., 1 [mu]g/ft\2\ for floors
and 10 [mu]g/ft\2\ for sills), 2/20 [mu]g/ft\2\, 3/30 [mu]g/ft\2\, and
5/40 [mu]g/ft\2\ and those values were compared with the specified BLL
and IQ metrics to estimate the probability of exceeding the BLL or IQ
targets.
In 2001 and 2019, EPA expressed the challenges of meeting the
statutory criterion for defining a LBP hazard (15 U.S.C. 2681(10))
because it requires EPA to choose a cutoff for when unacceptable risk
exists. EPA noted in 2001, even if the science and environmental-lead
prevalence data were perfect, there would likely be no agreement on the
level, or certainty, of risk that is envisioned in the phrase ``would
result in adverse human health effects.'' Thus, EPA explained that it
``would not be appropriate to base a [LBP] hazard standard on any
specific probability of exceeding any specific [BLL].'' (Refs. 2 and
20).
For this numeric approach the Agency would need to establish a
health or exposure metric of interest (i.e., target BLL or IQ change)
that would be acceptably protective of human health. Under this numeric
standard approach, EPA planned to use the threshold of 5% probability
of exceedance for a child from the population of interest (i.e., young
children living in pre-1978 housing and COFs). This is similar to the 1
to 5% probability that was used in 2001 for the lowest DLHS candidate
(Ref. 20). However, EPA ultimately continues to agree with the
challenges that were highlighted in 2001 and 2019, and the complexity
with identifying a cutoff of risk or specific IQ/BLL metrics of
interest that would be acceptable for purposes of setting the DLRL.
Accordingly, EPA continues to favor the ``any reportable level''
approach.
EPA also considered and requested comment on the ``post-1977''
background approach that would use the average background dust-lead
levels of housing built in 1978 and beyond as the DLRL. This approach
would align target housing dust-lead levels with dust-lead levels in
housing built after lead-based paint was banned. In 1978, the CPSC
banned lead in paint and similar surface-coating materials for consumer
use in excess of 0.06% and revised the level in 2009 to 0.009%
following the Consumer Product Safety Improvement Act of 2008 (Pub. L.
110-314). As a result of CPSC's 1978 lead paint ban, the focus of EPA's
LBP activities program is target housing, which includes most pre-1978
housing and COFs. This approach would result in lowering the DLRL to
the dust-lead background levels of housing built after 1977 (known as
``post-1977 background''), which are presumably not from paint on the
house in question containing more than 0.06% lead.
Post-1977 background dust-lead values were calculated from a
weighted geometric mean of the dust-lead loadings from the American
Healthy Homes Survey II and were found to be 0.2 [micro]g/ft\2\ for
floors and 0.8 [micro]g/ft\2\ for window sills (Refs. 10 and 53).
Setting the DLRL at the post-1977 background dust-lead levels would
allow EPA to focus on dust-lead hazards above what is expected in
housing without LBP (i.e., after CPSC established a maximum level of
lead in paint for consumer products, including home paints).
Establishing DLRL for target housing and COFs in this way, using post-
1977 background
[[Page 89435]]
dust-lead levels, would address disparities in the dust-lead levels
that children in target housing may be exposed to and the corresponding
disparate health risks. This approach would also align with the focus
of Title X on lead hazards in housing constructed before 1978. However,
there are questions about whether the post-1977 background approach
would directly address the 2021 Court Opinion as the ``any reportable
level'' approach does.
See the 2023 Proposed Rule for more detailed information about
these two approaches, including a description of their estimated
modeling results, such as BLL/IQ decrement impacts (Ref. 55). EPA did
not receive significant public comment for either of these approaches
and given the 2021 Court Opinion remanding the DLHS for reconsideration
based only on health factors, the results of the analysis in the TSD,
and the lack of a discernible threshold in the evidence for the
association of blood lead with harmful effects on cognition in young
children, EPA is finalizing revisions to the 2019 DLHS to any
reportable level of lead analyzed by an NLLAP-recognized laboratory, as
proposed.
C. Dust-Lead Action Level Approach
TSCA Title IV granted EPA the authority to regulate LBP activities,
and to take into account reliability, effectiveness, and safety (15
U.S.C. 2682(a)(1)) when setting those regulations (including the DLAL).
While considering those three criteria, the 2001 LBP Hazards Rule
modified the work practice standards to include DLCL (described as DLAL
moving forward), which ``are used to evaluate the effectiveness of
cleaning following an abatement'' (Ref. 20). In both the 2001 LBP
Hazards Rule and the 2021 Final Rule, the DLCL were finalized as the
same value as the DLHS (described as DLRL moving forward) for floors
and window sills. When originally established, EPA considered the DLCL
in the broader context of Title X, and selected DLCL that were
compatible with a ``workable framework for lead-based paint hazard
evaluation and reduction.'' EPA chose DLCL that were consistent with
the DLHS in part to ensure they were ``as easy as possible to
understand and implement'' (Ref. 66). At that time EPA established the
DLCL and the DLHS at 40 [mu]g/ft\2\ and 250 [mu]g/ft\2\ for floors and
window sills, with a separate DLCL of 400 [mu]g/ft\2\ for troughs.
In 2021 the DLCL set by EPA continued to mirror the DLHS as it had
done historically, as the Agency explained that it wanted to update the
DLCL to achievable levels that would demonstrate elimination of dust-
lead hazards under the 2019 DLHS of 10 [mu]g/ft\2\ for floors and 100
[mu]g/ft\2\ for window sills. The 2021 updates to the DLCL restored
consistency between the DLCL and DLHS, which had been lowered in 2019
without a corresponding amendment to the DLCL. Previous public comments
received on the 2018 DLHS proposal and 2020 DLCL proposal favored
lowering the DLCL to be consistent with the DLHS (Refs. 90 and 91). As
a result, in 2021 EPA finalized DLCL of 10 [mu]g/ft\2\ for floors and
100 [mu]g/ft\2\ for window sills (the same levels as the DLHS), and
``EPA considered the achievability of these levels, how the lower dust-
lead loadings can be reliably detected by laboratories, the
effectiveness of these levels, and consistency with the revised 2019
standards and across the Federal Government'' (Ref. 3).
The 2021 Court Opinion affirmed that ``TSCA [Title] IV gives the
EPA latitude to consider `reliability, effectiveness, and safety'''
when promulgating regulations ``[w]ith respect to implementation,
including abatement.'' A Cmty. Voice, 997 F.3d at 995 (Ref. 9). This
would include the DLCL/DLAL as they represent part of post-abatement
work practices. The Court continued by emphasizing that this gives EPA
more discretion when setting the DLCL because they are relevant to the
implementation of remedial measures, rather than the identification of
a hazard (i.e., DLHS/DLRL). The Court analogized this dichotomy to
other environmental statutory schemes (see also Unit IV.B.1.b. for
EPA's discussion of the SDWA). The Court also held that the DLCL and
DLHS are directly related and must be reconsidered together. Yet the
Court recognized the difference in statutory authority and
considerations (see Unit IV.B. for more information on DLRL, previously
referred to as DLHS).
In accordance with the 2021 Court Opinion, EPA is finalizing
revisions to the DLAL (previously referred to as the DLCL) in the same
proceeding as the reconsideration of the 2019 DLHS (described as DLRL
moving forward). Given the Court's direction for the considerations for
how to revise the DLHS and DLCL and similar to what was proposed in
2023, EPA is finalizing dust-lead action levels that are decoupled from
the dust-lead reportable levels (see Unit I.B. and C. for more
background on decoupling). EPA evaluated the 2021 DLCL in accordance
with the statute and is finalizing revisions to lower the levels to the
alternative option that was proposed in 2023, from 10 [micro]g/ft\2\,
100 [micro]g/ft\2\ and 400 [micro]g/ft\2\ for floors, window sills, and
troughs, respectively, to 5 [micro]g/ft\2\, 40 [micro]g/ft\2\, and 100
[micro]g/ft\2\ and is finalizing a change in the terminology to DLAL.
1. Rationale for Selecting the Final DLAL
EPA is finalizing the DLAL given the statutory criteria of
reliability, effectiveness, and safety, based on consideration of HUD's
Lead Hazard Control Clearance Survey (LHCCS), an evaluation of
laboratory capabilities and capacity, the potential for risk reduction
compared to the 2021 DLCL by lowering exposure to dust-lead, resource
considerations and the Agency's careful review of the public comments
received on the proposal. EPA chose 5 [mu]g/ft\2\, 40 [mu]g/ft\2\, and
100 [mu]g/ft\2\ for floors, window sills and window troughs,
respectively, as the DLAL based on these consideration as well as high
confidence that these standards can be successfully implemented, as
shown by the use of these clearance levels currently in NYC. Another
consideration supporting the choice of these DLAL is to avoid
potentially spreading the limited resources for LBP hazard mitigation
so broadly that they may be diverted from scenarios that present the
greatest risk.
a. Lead Hazard Control Clearance Survey.
EPA collaborated with HUD to develop the 2015 LHCCS. The survey
aimed to examine whether HUD's Office of Lead Hazard Control and
Healthy Homes (OLHCHH) Lead Hazard Control (LHC) grantees could achieve
DLCL (described as DLAL moving forward) below the standards in place at
that time (i.e., below 40 [micro]g/ft\2\, 250 [micro]g/ft\2\ and 400
[micro]g/ft\2\ for floors, window sills and troughs, respectively). LHC
work performed by the grantees must be conducted by LBP certified
individuals. Since most of the LHC grantees use commercial firms in
their area, HUD OLHCHH believes that the grantees are conducting a
large percentage of these activities and are therefore representative
of the regulated community.
98 LHC grantees completed the 2015 survey, giving HUD information
from housing units in which lead hazard control activities took place
from 2010 through 2012, for a total dataset of 1,552 housing units
including 7,211 floor samples and 4,893 window sill samples (Ref. 54).
The data were analyzed to determine the percentage of samples cleared
at or below specific values. Numerical modeling was performed to
estimate loadings that fell below laboratory detection limits. For more
information on how that analysis was
[[Page 89436]]
conducted please see appendix D of the EA (Ref. 10). Since the 2015
LHCCS report was published, to the Agency's knowledge, there has not
been any data or source of information of this magnitude in terms of
clearance samples alongside the details of the process, including the
number of tests performed (with results) and the type of additional
work or cleaning performed. EPA found this 2015 LHCCS report still
relevant and recent enough to provide meaningful input to inform this
reconsideration rulemaking.
EPA's analysis of the LHCCS data indicates that 72% of samples from
2010 to 2012 showed dust-lead levels at or below 5 [mu]g/ft\2\ for
floors, 88% were at or below 40 [mu]g/ft\2\ for window sills, and 93%
were at or below 100 [mu]g/ft\2\ for window troughs. As a result, EPA
believes that the final DLAL of 5 [micro]g/ft\2\ for floors, 40
[micro]g/ft\2\ for window sills and 100 [micro]g/ft\2\ for troughs are
achievable by LBP professionals, especially since the survey
respondents were only required to achieve clearance below the 2001 DLCL
at that time (40 [micro]g/ft\2\ for floors, 250 [micro]g/ft\2\ window
sills, and 400 [mu]g/ft\2\ for window troughs). It is possible that the
percentage of samples achieving clearance may be even higher today, due
to the 2021 revision of the DLCL to 10 [micro]g/ft\2\ for floors and
100 [micro]g/ft\2\ for window sills, meaning clearance has had to be
achieved at these lower levels or below, since that time. As a result,
EPA has high confidence that the 5 [micro]g/ft\2\, 40 [micro]g/ft\2\,
and 100 [micro]g/ft\2\ for floors, window sills, and window troughs
DLAL option is achievable by LBP professionals, considering reliability
and effectiveness.
b. Laboratory Capabilities for DLAL
In order to better understand how laboratory capabilities would be
impacted by the proposed DLAL (previously referred to as DLCL) of 3
[mu]g/ft\2\, 20 [mu]g/ft\2\, and 25 [mu]g/ft\2\ for floors, window
sills and troughs, respectively, and the final DLAL of 5 [mu]g/ft\2\,
40 [mu]g/ft\2\, and 100 [mu]g/ft\2\, EPA spoke with eighteen NLLAP-
recognized laboratories, nine prior to the 2023 Proposed Rule and nine
after the public comment period was complete (Refs. 92, 93, 94, 95, 96,
97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108 and 109). EPA
wanted to collect additional information from NLLAP-recognized
laboratories about their dust-wipe programs, especially given that a
non-static DLRL would shift the LQSR ``action level'' to the DLAL (see
Unit IV.B.1.a. for more information). As explained in the proposal, EPA
was interested in information from laboratories who had high dust wipe
testing capacity and laboratories that had both a flame atomic
absorption spectroscopy (FAAS) and the more sensitive laboratory
instruments such as inductively coupled plasma atomic emission
spectroscopy (ICP-AES) (also referred to as inductively coupled plasma
optical emission spectroscopy or ICP-OES) or an inductively coupled
plasma mass spectroscopy (ICP-MS). The Agency wanted additional
background on ICP instruments and their use for dust wipe testing in
general. After the public comment period, EPA wanted to continue
building on the outreach that had been previously performed and further
refine the Agency's understanding of the threshold for FAAS technology
in terms of a lower limit of sensitivity by meeting with nine
additional laboratories (eighteen total) and physically touring one
location (Ref. 101, 102, 103, 104, 105, 106, 107, 108 and 109). Among
the laboratories EPA spoke to in 2022, 2023 and 2024, 14 were
accredited to use FAAS, 10 were accredited to use ICP-AES, and 2 were
accredited to use ICP-MS to analyze dust wipe samples for lead, some
being accredited for multiple types of technology. Seventeen of the
eighteen laboratories provide commercial testing services, four of
which are among the largest U.S. lead laboratories by dust wipe test
volume. For additional details about the laboratory capabilities, see
Section 2.4 in the EA that accompanies this rulemaking (Ref. 10).
FAAS has been the most popular choice for lead dust wipe testing
for some time due in part to its low purchase price and operating cost,
speed, and ease of use. Over two-thirds of laboratories recognized
under the NLLAP for lead dust wipe testing currently use FAAS, and over
half of these NLLAP laboratories rely solely on FAAS (Ref. 10). The
laboratories using ICP-AES for dust-wipes tested an order of magnitude
fewer dust-wipe samples than laboratories using FAAS. Some of the
laboratories accredited for both types of instruments only use their
ICP instrument for wipes being analyzed for multiple metals for
industrial hygiene analyses or analysis of air or water samples instead
of for dust-wipes related to EPA's lead-based paint activities rule
(Refs. 97, 101, 104, 107, 108). One laboratory that uses both FAAS and
ICP-AES indicated that it used FAAS for 95% of the samples tested and
ICP-AES for only 5% (Ref. 98). Another laboratory that uses both FAAS
and ICP-AES stated that it used the ICP-AES instrument to test
approximately 20 dust-wipes per year, out of 34,000 to 36,000 lead
dust-wipes that it analyzes each year (Ref. 104).
The information received from the laboratory outreach that was
performed in preparation for the proposed rule indicated that if
finalized as proposed, ICP-AES would likely become the instrument
standard for dust wipe testing for lead at the NLLAP laboratories, as
FAAS instruments were not reported to consistently meet the
quantitation limits associated with the proposed DLCL. ICP-AES
instruments can detect lead at lower levels than FAAS instruments, but
ICP-AES instruments are more expensive to purchase, have higher
operating costs for consumable supplies, require a more experienced
technician to operate, and need more time for sample preparation,
analysis, and quality control requirements than FAAS instruments.
Laboratories raised several concerns about switching to ICP
instruments, including the reduction in the throughput rate, the need
for multiple instruments and staff to operate them, higher prices,
delayed turnaround times, and concerns over maintaining the current
sample volume. For example, one laboratory EPA spoke to estimated that
they would have to purchase three to six new instruments, hire several
highly qualified technicians, and run the laboratory on shifts over 24
hours to meet current demand for dust wipe tests conducted solely by
ICP (Ref. 96). Several laboratories questioned whether they would keep
dust-wipe testing in their portfolio if EPA finalized the levels from
the 2023 Proposed Rule (Refs. 96, 98, 103, 107).
This shift in instrumentation that would have been needed as a
result of the clearance levels in the proposed rule would increase both
cost per sample as well as turnaround time. Dust wipe testing by ICP-
AES is approximately two to four times more expensive per sample than
testing by FAAS (Refs. 96, 98, 100, 104, 108). Laboratories also
mentioned that a substantial portion of their dust-wipe testing clients
request results in one day or less (in some cases in as little as
several hours) following a lead hazard reduction activity, so that
residents can quickly reoccupy their homes (Refs. 95, 101, 103). Some
of the laboratories using FAAS indicated that they offered turnaround
times as short as several hours (Refs. 96, 104, 107). Several
laboratories doubted the feasibility of providing same-day or next-day
turnarounds at sufficient volume should they switch to ICP technology
(Refs. 96, 98, 104, 108). Longer turnaround times would delay when
individuals who temporarily
[[Page 89437]]
moved out can reoccupy their homes, requiring them to spend more time
in temporary accommodations (Ref. 91) which can increase the costs of
lead hazard reduction activities, thus potentially reducing the number
of abatements and interim control that would be funded.
EPA found that several laboratories forecast that dust-wipe test
volumes will continue to grow over the next decade even in the absence
of this rule (Refs. 96, 97 and 102). First, a growing proportion of
laboratories' dust-wipe testing business comes from landlords who need
to comply with municipal housing regulations set by States or
localities. Laboratories expect similar regulations to be enacted in
the coming years, increasing demand for dust-wipe testing for clearance
(Ref. 97). Second, in recent years laboratories have received an
increased volume of test samples generated by disaster recovery
programs. When there is a natural disaster (such as a major flood) that
requires clean-up and re-construction of pre-1978 housing, laboratories
can receive an unexpected spike in dust-wipe tests. Laboratories
pointed out that the increasing rate of disaster-related demand spikes
may overwhelm their capacity if only ICP can be used for dust-wipe
testing.
Finally, laboratories also expressed concern that increases in
costs for activities such as testing, cleaning, and temporary
accommodations due to the dust-lead levels EPA originally proposed
would reduce the number of housing units where lead hazards would be
addressed, in part because State and local municipalities often have a
fixed budget for their housing and health programs (Refs. 96 and 108).
The laboratories felt that the 2023 Proposed Rule could have the
unintended result of exposing more individuals to elevated dust-lead
levels for a longer period of time (Refs. 108 and 109). Given the
information gathered via EPA's outreach to laboratories, EPA is
concerned that setting action levels too low would deter participation
in lead-hazard control programs and activities that require dust-wipe
testing or cause a market failure that does not allow the current
volume of testing to continue.
EPA is finalizing a DLAL of 5 [mu]g/ft\2\, 40 [mu]g/ft\2\, and 100
[mu]g/ft\2\ for floors, window sills and troughs. EPA has increased
confidence that, relative to the proposed 2023 DLCL (i.e., 3 [mu]g/
ft\2\, 20 [mu]g/ft\2\, and 25 [mu]g/ft\2\), laboratories can
numerically quantify dust-lead levels of 5 [mu]g/wipe with FAAS
technology and attain a quantitation limit of equal to or less than 80%
of the final DLAL (i.e., 4 [mu]g/ft\2\, 32 [mu]g/ft\2\, and 80 [mu]g/
ft\2\) for floors, window sills and troughs. EPA believes that the
final DLAL, rather than the proposed 2023 DLCL, partnered with the
changes incorporated into LQSR 4.0, allows NLLAP-recognized
laboratories to continue using FAAS technology. This would mitigate any
unintended reductions in dust wipe capacity (e.g., throughput time,
cost, labor, etc.) due to having to switch to more sensitive technology
such as ICP-AES. While some NLLAP-recognized laboratories may opt for
more sensitive technologies, EPA does not foresee any concerns
reporting to 5 [mu]g/ft\2\, 40 [mu]g/ft\2\, and 100 [mu]g/ft\2\ even
for those surfaces with a smaller area such as on window sills or
troughs if laboratories successfully attain a regulatory limit of 5
[mu]g/ft\2\.
c. Final DLAL Modeling Results
EPA must understand the estimated health impacts of dust-lead
exposure when selecting a DLAL that is reliable, effective, and safe,
as well as to help inform the economic analysis. The TSD that
accompanies this rule includes an evaluation of dust-lead loadings,
specifically the 2021 DLCL of 10 [mu]g/ft\2\ and 100 [mu]g/ft\2\ for
floors and window sills, the proposed DLAL of 3 [mu]g/ft\2\ and 20
[mu]g/ft\2\ for floors and window sills and the final DLAL of 5 [mu]g/
ft\2\ and 40 [mu]g/ft\2\ for floors and window sills, compared to
estimated BLL and IQ decrements. The unique dust-lead contribution to
exposure from window troughs has not been distinguished from window
sills given the strong correlation between dust-lead loadings on the
two surface types, the lack of data on access to window troughs and
window sills by children, and the paired impacts in window sills and
window troughs from intervention studies addressing lead paint in
window trim and casings. Further discussion on exposure to window
troughs can be found in the TSD in appendix C. As a result, exposure to
window trough dust-lead and resultant benefits from a lowered DLAL for
troughs is not calculated separately for this rulemaking. The TSD also
describes modeling of dust-lead exposures at the specific DLAL options
for window sills and floors only and estimates of both BLLs that were
evaluated for children at each age up to age six, including age two
(generally, this is the age of greatest modeled exposure), and lead-
related reduction in IQ at age six was estimated from the lifetime
average BLL (average of BLLs across the period prior to age six). See
Unit IV.B.1.c. for more specific information on which BLL and IQ
decrements were chosen for comparison, and Unit III. for more details
on estimated potential impacts from dust-lead exposures analyzed in the
TSD. Tables 5 and 6 represent the percent exceedance of highlighted
metrics at dust-lead loadings corresponding to the 2021 DLCL (10 [mu]g/
ft\2\ and 100 [mu]g/ft\2\ for floors and window sills), the final DLAL
(5 [mu]g/ft\2\ and 40 [mu]g/ft\2\ for floors and window sills) and zero
(for comparison purposes only).
The final DLAL of 5 [mu]g/ft\2\, 40 [mu]g/ft\2\, and 100 [mu]g/
ft\2\ for floors, window sills and troughs represents a 50% or more
reduction of dust-lead left on a surface following the completion of an
abatement, when compared to the 2021 DLCL (10 [mu]g/ft\2\, 100 [mu]g/
ft\2\, and 400 [mu]g/ft\2\). As a result, DLAL of 5 [mu]g/ft\2\, 40
[mu]g/ft\2\, and 100 [mu]g/ft\2\ would be beneficial to maintaining
lower children's BLLs and protecting against associated health outcomes
such as decreased IQ. The modeling results provided in the TSD show
that 2-year-old children in pre-1978 housing exposed to dust-lead
loadings of 5 [mu]g/ft\2\ for floors and 40 [mu]g/ft\2\ for window
sills would have an estimated 13.9% probability of exceeding a total
BLL of 3.5 [mu]g/dL (CDC's BLRV). Total BLL includes exposure from
other media such as soil, diet, water, and air; even at zero dust-lead,
2-year-old children would still have a 5.7% probability of exceeding
the CDC's BLRV from these other sources. The 13.9% probability of
exceeding the BLRV is significantly lower than the 18.0% probability of
exceedance of the BLRV when exposed to the current DLCL of 10 [mu]g/
ft\2\ for floors and 100 [mu]g/ft\2\ on window sills (see table 5).
When considering dust-lead exposure only (not including other
estimated lead exposures from soil, diet, water, and air), 2-year-old
children in pre-1978 housing exposed to the final DLAL of 5 [mu]g/
ft\2\, 40 [mu]g/ft\2\, and 100 [mu]g/ft\2\ would have a 3.2 to 23.0%
probability of exceeding a BLL of 1 to 2.5 [mu]g/dL based on the
modeled results. The final DLAL is also estimated to be associated with
a 22.4% probability of exceeding 2 points of IQ decrement in 6-year-old
children. As with total BLL, this is a considerable reduction from the
37.9% chance of exceeding 2 points of IQ decrement for 6-year-old
children living in target housing who are exposed the current DLCL
(table 6). Overall, the modeling within the TSD indicated that the 5
[mu]g/ft\2\, 40 [mu]g/ft\2\, and 100 [mu]g/ft\2\ DLCL for floors,
window sills and troughs represents a substantial reduction in risk
from the current clearance levels of 10 [mu]g/ft\2\, 100 [mu]g/ft\2\,
and 400 [mu]g/ft\2\ for floors, window sills, and window troughs.
[[Page 89438]]
Table 5--Percent Exceedance Values for the Final DLAL Candidate, Age: 2-Year-Old (30 months)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Probability
---------------------------------------------------------------
Approach Floor ([mu]g/ Sill ([mu]g/ Total BLL > Dust Only BLL Dust Only BLL
ft\2\) ft\2\) 3.5 [mu]g/dL Total BLL > 5 > 1 [mu]g/dL > 2.5 [mu]g/
(%) [mu]g/dL (%) (%) dL (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Zero \1\................................................ 0 0 5.7 2.2 0.0 0.0
5/40 DLAL............................................... 5 40 13.9 5.5 23.0 3.2
Current Standard........................................ 10 100 18.0 7.5 36.7 6.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The exceedance values for zero dust-lead are provided for comparison with the DLRL candidates; it is not a candidate value and is for informational
purposes only.
Table 6--Percent Exceedance Values for the Final DLAL Candidate, Age: 6-Year-Old (72 Months)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Probability
---------------------------------------------------------------
Approach Floor ([mu]g/ Sill ([mu]g/ Total IQ Total IQ Dust Only IQ Dust Only IQ
ft\2\) ft\2\) Decrement > Decrement > Decrement > Decrement >
1pt (%) 2pt (%) 1pt (%) 2pt (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Zero \1\................................................ 0 0 88.9 48.7 0.0 0.0
5/40 DLAL............................................... 5 40 98.8 85.1 62.7 22.4
Current Standard........................................ 10 100 99.4 90.3 75.8 37.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The exceedance values for zero dust-lead are provided for comparison with the DLRL candidates; it is not a candidate value and is for informational
purposes only.
These estimates represent post-abatement exposure at the exact
dust-lead loadings of the final DLAL, but levels below those values
must be achieved in order for an abatement to be considered complete.
The subpopulation of children affected by this rule (i.e., children
with pre-abatement dust-lead exposures above the action level)
experience pre-abatement dust lead loadings that are in the upper
percentiles of children living in target housing (Ref. 71). As a
result, it is likely that actual exceedances among the full population
of children in target housing (i.e., not only those who are affected by
this rule, but all children who reside in housing constructed before
1978) are lower than what is represented in the TSD for the
subpopulation affected by this rule. In contrast to the TSD, which
estimates the health risk and exposure associated with dust-lead
loading candidates for a hypothetical population of children in target
housing without consideration to how many children are actually
affected by the rule, the EA estimates benefits that accrue to only the
subpopulation that would be impacted by the DLRL and DLAL revisions.
See the Technical Support Document and Economic Analysis that accompany
this rulemaking for more information (Refs. 10 and 12).
d. New York City
Between 2019 and 2021 NYC Department of Health and Mental Hygiene
lowered their lead dust clearance and lead dust hazard risk assessment
testing standards twice. NYC lowered their standards for floors, window
sills and window wells (i.e., troughs), respectively, from 40 [mu]g/
ft\2\, 250 [mu]g/ft\2\, and 400 [mu]g/ft\2\ to 10 [mu]g/ft\2\, 50
[mu]g/ft\2\, and 100 [mu]g/ft\2\ in 2019 (effective June 12, 2019) and
again to 5 [mu]g/ft\2\, 40 [mu]g/ft\2\, 100 [mu]g/ft\2\ in 2021
(effective June 1, 2021) (Refs. 110 and 111). The Agency spoke to the
New York City Department of Health and Mental Hygiene and received
feedback during the development of the proposed rule that although
there was a transitionary period that lasted several months and had
various challenges, overall, the regulated community was able to adjust
and comply with the new lower standards (Ref. 112). EPA believes that
NYC's experience supports considering the final DLAL of 5 [mu]g/ft\2\,
40 [mu]g/ft\2\, 100 [mu]g/ft\2\ for floors, window sills and window
troughs to be effective and reliable.
e. Public Comment Input
EPA received a number of comments during the public comment period
that supported the proposed DLCL approach (described as DLAL moving
forward) of 3 [mu]g/ft\2\, 20 [mu]g/ft\2\, and 25 [mu]g/ft\2\ for
floors, window sills and troughs, respectively, on the grounds that
lowering the levels will further protect children from lead exposure. A
mass mail campaign, which consisted of a coalition of 76 organizations
and twelve individuals affirmed that the proposed levels promoted the
greatest safety for those living in target housing, ensuring remedial
measures meaningfully reduce the amount of dust-lead that remains in
homes and child care facilities. Multiple comments were also received
expressing a lack of support for the proposed DLCL (described as DLAL
moving forward). Many commenters requested that the levels remain at
the current 2021 values of 10 [mu]g/ft\2\, 100 [mu]g/ft\2\, and 400
[mu]g/ft\2\ for floors, window sills, and window troughs, respectively.
Several commenters also requested the alternative DLCL of 5 [mu]g/
ft\2\, 40 [mu]g/ft\2\, and 100 [mu]g/ft\2\ for floors, window sills,
and window troughs rather than the proposed levels. Of those comments
that expressed opposition to the proposed DLCL, the concerns were
focused around a reduction of laboratory capacity (due to needing to
switch to an ICP, which is more sensitive technology), the lack of
adequate surface area for both window sill and trough sampling, the
potential for this being a deterrent within the industry from
performing LBP activities due to an increase in cost, burden,
complexity, and a reduction in contractor availability.
Firstly, in response to the support for the proposed DLCL, EPA
agrees and acknowledges that according to the results from the
technical support document, as dust-lead levels in housing dust-lead
levels in housing decrease below the current DLCL (i.e., 10 [mu]g/
ft\2\, 100 [mu]g/ft\2\, and 400 [mu]g/ft\2\ for floors, window sills,
and window troughs), children's BLLs and associated IQ decrements from
lead exposure are also expected to decrease. As a result, a lower DLAL
is assumed to be more protective at a particular site than one that
results in higher dust-lead loadings. However, based on the public
feedback and the response to the 2023 Proposed Rule, as well as
laboratory outreach, (see Unit IV.C.1.b. ``Laboratory capabilities
[[Page 89439]]
for DLAL'' for more information), EPA is concerned that if the DLAL
were set too low, limited resources for LBP mitigation would be
distributed more broadly, diverting them from the most vulnerable
communities or situations that present more serious risks to those that
present lower risks. EPA is also concerned that increased costs due to
the proposed DLCL could result in less LBP work taking place overall.
EPA's analysis indicates that the final rule's approach to the DLAL is
the most cost-effective option analyzed for both the cost per lost IQ
point avoided and the cost per ADHD case avoided, as explained in
Section 7 of the UMRA Statement. These two benefit types accrue to the
most sensitive population affected by this final rule (i.e., children).
Assuming limited resources for LBP mitigation, achieving these benefits
more cost effectively would result in more lost IQ points avoided and
more ADHD cases avoided. Additionally, EPA believes that access to
housing is also an important social determinant of health and research
finds negative health effects resulting from a lack of safe and
adequate housing. Due to the public comments received, EPA has concerns
that the proposed DLCL could unintentionally contribute to housing
insecurity and longer turnaround times for post-abatement testing,
which could impact access.
Secondly, safety is only one aspect of the statutory authority for
reconsidering the DLAL (i.e., reliability, effectiveness and safety).
In particular, the Ninth Circuit affirmed that when reconsidering the
clearance levels ``we must give effect to Congress's clear intent for
EPA to consider both health and nonrisk factors.'' Cmty. Voice, 997
F.3d at 995. As a result, the DLAL is not a solely health-based
standard; rather it also considers what cleanup after an abatement is
adequately reliable and effective. EPA agrees with commenters that the
2023 proposed DLCL of 3 [mu]g/ft\2\, 20 [mu]g/ft\2\, and 25 [mu]g/ft\2\
for floors, window sills, and window troughs respectively, partnered
with the revisions in LQSR 4.0 would not present a problem, in terms of
testing sensitivity, for laboratories using ICP-AES/OES. However, the
majority of laboratories recognized under the NLLAP for lead dust wipe
testing currently favor the less sensitive FAAS. EPA continues to
believe that if the Agency finalized the DLCL as proposed, then ICP-AES
would likely become the instrument standard for dust wipe testing for
lead at the NLLAP laboratories. As a result, numerous public comments
were received expressing concern over this switch; FAAS has been the
most popular choice for lead dust wipe testing for some time due in
part to its low purchase price and operating cost, speed, and ease of
use. During the laboratory outreach that was performed for rule
development, laboratories raised several concerns about switching to
ICP instruments, the reduction in the throughput rate, the need for
multiple instruments and staff to operate them, higher prices, delayed
turnaround times, and concerns over maintaining the current sample
volume. See Unit IV.C.1.b. for more discussion surrounding laboratory
capabilities and capacity. Ultimately, due to public comments received,
laboratory outreach and concerns raised about the reliability and
effectiveness of the lower proposed DLCL, EPA is finalizing the
alternative values of 5 [mu]g/ft\2\, 40 [mu]g/ft\2\, and 100 [mu]g/
ft\2\ for floors, window sills, and window troughs respectively. EPA
does not want to create a program that raises significant feasibility
concerns, or that inadvertently reduces the number of abatement jobs
that the regulated community is able to perform (due to a dilution of
intervention resources), thus potentially impacting families and
children and resulting in less of an overall reduction in dust-lead.
A more comprehensive version of EPA's responses on all of these
issues can be found in the response to comments document that
accompanies this rulemaking (Ref. 38).
2. Other Approach EPA Considered in the Proposed Rule
In 2023 EPA proposed to revise the 2021 DLCL from 10 [mu]g/ft\2\,
100 [mu]g/ft\2\ and 400 [mu]g/ft\2\ for floors, window sills, and
troughs to 3 [mu]g/ft\2\, 20 [mu]g/ft\2\, and 25 [mu]g/ft\2\, and
requested comment on an alternative DLCL option of 5 [mu]g/ft\2\, 40
[mu]g/ft\2\, and 100 [mu]g/ft\2\. According to the 2015 LHCCS report,
64% of the 2010 to 2012 samples showed dust-lead levels at or below 3
[mu]g/ft\2\ for floors, 64% were at or below 20 [mu]g/ft\2\ for window
sills, and 64% were at or below 25 [mu]g/ft\2\ for window troughs. As a
result, approximately 64% of samples from the LHCCS data had dust-lead
levels at or below the primary DLCL option of 3 [mu]g/ft\2\ for floors,
20 [mu]g/ft\2\ for window sills and 25 [mu]g/ft\2\ for troughs, which
EPA thought was achievable, especially since the survey respondents
were only required to achieve clearance below the 2001 DLCL at that
time (40 [mu]g/ft\2\, 250 [mu]g/ft\2\, and 400 [mu]g/ft\2\ for floors,
window sills and troughs, respectively). However, given the concerns
highlighted by public commenters and during laboratory outreach, EPA is
finalizing the alternative DLCL option of 5 [mu]g/ft\2\, 40 [mu]g/
ft\2\, and 100 [mu]g/ft\2\ along with the terminology change to DLAL.
See the 2023 Proposed Rule for more detailed discussion about the
proposed DLCL (Ref. 55).
D. Cross Reference With HUD Regulations
EPA is finalizing modifications to 40 CFR 745.227(h) to clarify
that the final DLAL would differ from the final DLRL, and that the
Agency does not intend to compel LBP professionals to reduce dust-lead
loadings all the way below the DLRL, just to below the DLAL. EPA is
interested in alleviating any potential regulatory confusion
surrounding clearance to the DLAL. HUD's LSHR clearance regulations at
24 CFR 35.1340(d), which apply to both abatement and interim control
and paint stabilization activities above HUD's de minimis amount of
disturbance of paint known or presumed to be lead-based paint at 24 CFR
35.1350(d), currently refer to 24 CFR 35.1320(b)(2). HUD's regulations
at 24 CFR 35.1320(b)(2) in turn cross-references EPA's regulations at
40 CFR 745.227(h), which currently discusses EPA's DLHS (described by
EPA as DLRL moving forward) but not EPA's DLCL (described by EPA as
DLAL moving forward). See Unit III.A.3.f the 2019 Final Rule for
additional background on this topic (Ref. 2). As explained earlier in
this preamble, prompted by analysis conducted following the 2021 Court
Opinion, EPA is finalizing a DLRL that is no longer the same value as
the DLAL. As a result, EPA is amending the language at 40 CFR
745.227(h), so it is clear when referenced by the LSHR, that EPA does
not intend to compel clearance below the DLRL, but below the DLAL,
whether in federally assisted housing or not.
In the course of reviewing this amendment to 40 CFR 745.227(h), EPA
realized that the regulation at 40 CFR 745.227(h)(2)(i) inadvertently
refers to ``dust hazard levels identified in [40 CFR] 745.227(b).'' 40
CFR 745.227(b) actually addresses how to conduct an inspection and does
not address dust hazard levels. Based on its context and the parallel
language in 40 CFR 745.65(a)(1), the cross-reference in 40 CFR
745.227(h)(2)(i) was intended to refer to 40 CFR 745.65(b), which does
identify what constitutes a dust-lead hazard. EPA has updated the
cross-reference accordingly in order to remove any ambiguity.
E. Definition of Abatement
EPA is finalizing amendments to the definition of abatement in
EPA's LBP activities regulations, specifically for dust-lead hazards,
and thus modifying
[[Page 89440]]
the trigger for when EPA recommends an abatement. This change is a key
element of the final rulemaking and is intended to align with the
decoupling of the DLRL and DLAL, ultimately focusing the impacted
entities' resources (e.g., HUD, city, State) on the situations that
present the most risk while still identifying and disclosing lower
levels of concern. EPA has narrowly focused the amendments on the
portions of the definition that address dust-lead. The abatement
definition still applies unchanged with respect to paint-lead and soil-
lead. TSCA section 401(1) defines an abatement as ``any set of measures
designed to permanently eliminate lead-based paint hazards in
accordance with standards established by the Administrator under [TSCA
Title IV]'' and includes ``the removal of lead-based paint and lead-
contaminated dust, the permanent containment or encapsulation of lead-
based paint . . . and all preparation, cleanup, disposal, and post-
abatement clearance testing activities associated with such measures.''
EPA included a definition of abatement, which closely resembles the
statutory language, within the LBP activities regulations at 40 CFR
745.223. An abatement under the LBP activities regulations (40 CFR
745.223) is described as ``any measure or set of measures designed to
permanently eliminate lead-based paint hazards'' and specifically
includes ``projects resulting in permanent elimination of lead-based
paint hazards . . .''.
The 2021 Court Opinion stated that ``TSCA [Title] IV gives the EPA
latitude to consider `reliability, effectiveness, and safety''' when
promulgating regulations ``[w]ith respect to implementation, including
abatement'' (Ref. 9). In addition, the statutory definition of
abatement in TSCA section 401(1) specifically references the
elimination of hazards ``in accordance with standards established by
the Administrator under [TSCA Title IV].'' Hence, in considering
revising the DLAL as part of TSCA section 402's ``standards for
performing [LBP] activities,'' EPA must and has considered whether
reliability, effectiveness and safety support changing the regulatory
definition of abatement. Given that under this statutory scheme EPA
only intends to compel post-abatement clearance to the final DLAL, the
Agency is also changing the regulatory definition of abatement so that
the recommendation for action applies when dust-lead loadings are at or
above the DLAL (which continues to incorporate non-health-based factors
such as reliability), rather than at or above the hazard standards,
described as DLRL moving forward, as has been the case historically
(but which, going forward in accordance with the 2021 Court Opinion,
can no longer incorporate non-health-based factors such as
reliability). This revision is necessary due to the decoupling of the
DLRL from the DLAL and EPA's desire to avoid situations where
abatements are designed to eliminate dust-lead levels to the DLRL and
are unable to do so in a reliable and effective manner. Otherwise, EPA
would be recommending an abatement if dust-lead levels are between the
DLRL and the DLAL, even though such an abatement would only need to
attain dust-lead loadings below the DLAL. Also, where an abatement is
conducted, a cyclical pattern could result, where an abatement could
successfully pass clearance below the DLAL but an abatement would still
have been recommended by EPA if dust-lead levels were at or above the
DLRL. Thus, EPA is revising the regulatory definition to require that
abatements eliminate dust-lead hazards to below the DLAL to ensure that
successful abatements can be considered complete in accordance with
this rule's updated standards. Relatedly, as explained in Unit IV.F.,
EPA is proposing amendments to the abatement report to help protect
from exposure even after the abatement is complete.
An additional benefit to modifying the trigger for when EPA
recommends an abatement is that it allows the regulated community to
focus resources on situations that present more risk. As discussed in
the 2001 and 2019 final rules, an important concern for EPA is having
the resources for LBP hazard mitigation distributed so broadly that
they may be diverted from situations that present the greatest risk.
As a result, EPA is changing the regulatory definition of abatement
to permanently eliminate dust-lead hazards to below the DLAL. EPA
concludes that this amendment to the regulatory definition most
appropriately applies the statutory definition in the context of this
rule, where the statute requires EPA to consider reliability,
effectiveness, and safety for purposes of EPA's TSCA section 402 LBP
activities regulations (including the DLAL). Furthermore, as noted
earlier in this section, the statutory definition of abatement in TSCA
section 401 states that the set of measures covered by the term are to
be ``in accordance with the standards established by the
Administrator'' under TSCA Title IV, which refers to the ``standards
for performing [LBP] activities'' as what EPA's TSCA section 402
regulations shall contain. Thus, EPA has concluded that the amended
regulatory definition most appropriately implements the statutory
instruction that abatement measures be ``in accordance with'' this
rule's updated section 402 standards (notably, the revised DLAL). Note
that nothing in this rulemaking changes the fact that owners of
properties covered by the LBP Activities Rule are not compelled to
evaluate their properties for the presence of dust-lead hazards, nor
compelled by EPA to take action (such as an abatement) if dust-lead
hazards are identified at or above the DLAL, although HUD and some
State or local governments may require action.
F. Abatement Report
As explained in Units IV.A., B. and C., EPA is finalizing a
nomenclature change to the terminology for the standards, and lowering
the current DLRL to any reportable level as analyzed by an NLLAP-
recognized laboratory. Additionally, EPA is finalizing the DLAL to 5
[mu]g/ft\2\, 40 [mu]g/ft\2\, and 100 [mu]g/ft\2\ for floors, window
sills and troughs, respectively. The DLRL identify when pre-1978
housing or a COF has a dust-lead hazard present. Given this decoupling
of the floor and sill values, it is likely that once a project passes
clearance and the abatement can be considered complete, there could
still be dust-lead hazards present due to the DLRL being any reportable
level. The Agency realizes the challenge this creates for the regulated
community and, to keep dust-lead levels down and mitigate exposure, EPA
is proposing to amend the requirements for what needs to be included in
an abatement report.
After the completion of an abatement, the certified supervisor or
project designer is required to develop a report. The list of what
needs to be included in the abatement report is described at 40 CFR
745.227(e)(10), and consists of elements such as the start and
completion dates of the abatement, information about the risk assessor
or inspector conducting the sampling, any post-abatement dust-lead
testing and soil analyses, etc. EPA is modifying 40 CFR 745.227(e)(10)
to include a requirement to add specific language into each abatement
report, when dust-lead levels are between the DLRL and the DLAL. That
language refers the public to a useful reference titled ``Protect Your
Family From Lead in Your Home'' and acknowledges that LBP hazards
(particularly dust-lead hazards) could remain after an abatement. The
goal of including this language in an abatement report is to
[[Page 89441]]
ensure that occupants are provided with information about actions they
can take to minimize dust-lead hazards and protect themselves from
exposure even after an abatement is complete.
The certified firm (or individual who prepared the report) must
keep the abatement reports for at least 3 years and must provide a copy
to the individual or entity who ``contracted for its services'' (40 CFR
745.227(i)).
G. Other Amendments
In order to conform the regulations to a statutory change, make
several other amendments to improve efficiency of the program and make
several regulatory text corrections, EPA is finalizing the amendments
to 40 CFR part 745, subparts E (Residential Property Renovation), F
(Disclosure of Known Lead-Based Paint and/or Lead-Based Paint Hazards
Upon Sale or Lease of Residential Property), and L (Lead-Based Paint
Activities).
1. Definition of Target Housing
EPA is finalizing changes to the definition of target housing in 40
CFR 745.103 and 40 CFR 745.223 to align with the statutory changes made
in 2017 and is making conforming edits to language in 40 CFR 745.223
and 40 CFR 745.227. Target housing defines which housing is subject to
EPA's LBP rules. Within section 237(a) through (c) of Title II of
Division K of the Consolidated Appropriations Act, 2017 (Pub. L. 115-
31, 131 Stat. 788 and 789), Congress amended HUD and EPA's statutory
definitions of target housing to include 0-bedroom dwellings if a child
less than 6 years of age resides or is expected to reside in such
housing (42 U.S.C. 4822(e); 42 U.S.C. 4851(b)(27); 15 U.S.C. 2681(17)).
The change to the definition of target housing in 40 CFR 745.103 and 40
CFR 745.223 conforms to the statutory language by defining target
housing as any housing constructed prior to 1978, except housing for
older adults or persons with disabilities or any 0-bedroom dwelling
(unless any child who is less than 6 years of age resides or is
expected to reside in such housing). For consistency, EPA is also
finalizing revisions to the definition of living area in 40 CFR 745.223
to change the age from 6 and under to less than 6 years of age.
Similarly, language describing the age of children in 40 CFR
745.227(c)(2)(i), (c)(2)(iv), (c)(2)(v), (d)(3), (d)(5), and (d)(6)(ii)
was updated from 6 years of age and under to under age 6 to conform to
the statutory language as amended.
In the course of reviewing this amendment to 40 CFR
745.227(c)(2)(v), EPA realized that the regulation inadvertently refers
to a paragraph (c)(1)(iii) of the section when no such provision
exists. Based on its context, this cross-reference in paragraph
(c)(2)(v) was intended to refer to the floor and window samples
required by the immediately preceding provision (i.e., paragraph
(c)(2)(iv)). EPA has updated the cross-reference accordingly in order
to remove any ambiguity.
2. Definition of Child-Occupied Facility (COF) and Living Areas
EPA is finalizing revisions to the definition of COF in 40 CFR
745.223 and related regulatory language in 40 CFR 745.227 to establish
consistency throughout the LBP regulations. The LBP Activities
regulations define COFs as buildings or portions of buildings,
constructed prior to 1978, in which the same child regularly visits on
at least two different days within any given week, with their visits
lasting at least 3 hours with combined visits of at least 6 hours, and
combined annual visits lasting at least 60 hours. COFs may include, but
are not limited to, day-care centers, preschools and kindergarten
classrooms. Living areas are defined as any area of a residential
dwelling used by one or more children, which includes, but is not
limited to, living rooms, kitchen areas, dens, play rooms, and
children's bedrooms. Currently, the definition of COF at 40 CFR 745.223
identifies children impacted by the LBP Activities regulations as age 6
and under, while the definition of COF in the RRP regulations at 40 CFR
745.83 identifies children impacted by the RRP regulations as under 6
years of age. In order to establish consistency in age throughout the
LBP regulations, including with the definition of target housing and
the RRP regulations' definition of COF, EPA is finalizing the change to
the language in the definition of COF in 40 CFR 745.223 to less than 6
years of age. Language describing the age of children in
[…truncated; see source link]Indexed from Federal Register on November 12, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.