Review of the Dust-Lead Hazard Standards and the Definition of Lead-Based Paint, 32632-32648 [2019-14024]
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Federal Register / Vol. 84, No. 131 / Tuesday, July 9, 2019 / Rules and Regulations
EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus bodies. The
NTTAA directs the EPA to provide
Congress, through OMB, explanations
when the Federal agency decides not to
use available and applicable voluntary
consensus standards. This authorization
does not involve technical standards.
Therefore, the EPA is not considering
the use of any voluntary consensus
standards.
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
10. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
Executive Order 12898 (59 FR 7629,
February 16, 1994) establishes Federal
executive policy on environmental
justice. Its main provision directs
Federal agencies, to the greatest extent
practicable and permitted by law, to
make environmental justice part of their
mission by identifying and addressing,
as appropriate, disproportionately high
and adverse human health or
environmental effects of their programs,
policies, and activities on minority
populations and low-income
populations in the United States. The
EPA has determined that this final
authorization will not have
disproportionately high and adverse
human health or environmental effects
on minority or low-income populations.
This final authorization does not affect
the level of protection provided to
human health or the environment
because this document authorizes preexisting State rules which are equivalent
to and no less stringent than existing
Federal requirements.
Dated: June 13, 2019.
Michelle Pirzadeh,
Deputy Regional Administrator, EPA Region
10.
11. The Congressional Review Act, 5
U.S.C. 801–808
The Congressional Review Act, 5
U.S.C. 801–808, generally provides that
before a rule may take effect, the agency
promulgating the rule must submit a
rule report, which includes a copy of
the rule, to each House of the Congress
and to the Comptroller General of the
United States. The EPA will submit a
report containing this document and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication in the Federal Register. A
major rule cannot take effect until 60
days after it is published in the Federal
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List of Subjects in 40 CFR Part 271
Environmental protection,
Administrative practice and procedure,
Confidential business information,
Hazardous materials transportation,
Hazardous waste, Indians-lands,
Intergovernmental relations, Penalties,
Reporting and recordkeeping
requirements.
Authority
This final action is issued under the
authority of sections 1006, 2002(a),
3006, and 3024 of the Solid Waste
Disposal Act, as amended, 42 U.S.C.
6905, 6912(a), 6926, and 6939g.
[FR Doc. 2019–14019 Filed 7–8–19; 8:45 am]
BILLING CODE 6560–50–P
Constitution Ave. NW, Washington, DC.
The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPPT
Docket is (202) 566–0280. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: John
Yowell, National Program Chemicals
Division, Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460–0001; telephone
number: 202–564–1213; email address:
yowell.john@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
ENVIRONMENTAL PROTECTION
AGENCY
I. Executive Summary
40 CFR Part 745
A. Does this action apply to me?
[EPA–HQ–OPPT–2018–0166; FRL–9995–49]
You may be potentially 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 in
accordance with 40 CFR 745.226, or if
you conduct rehabilitations in
accordance with 24 CFR part 35. You
may also be affected by this action if
you operate a laboratory that is
recognized by EPA’s National Lead
Laboratory Accreditation Program
(NLLAP) in accordance with 40 CFR
745.90, 745.223, 745.227, 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. For further information
regarding the authorization status of
states, territories, and tribes, contact the
National Lead Information Center at
1–800–424–LEAD (5323). 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. Potentially affected
entities may include:
• Building construction (NAICS code
236), e.g., single-family housing
construction, multi-family housing
construction, residential remodelers.
RIN 2070–AJ82
Review of the Dust-Lead Hazard
Standards and the Definition of LeadBased Paint
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
Addressing childhood lead
exposure is a priority for EPA. As part
of EPA’s efforts to reduce childhood
lead exposure, EPA evaluated the
current dust-lead hazard standards
(DLHS) and the definition of lead-based
paint (LBP). Based on this evaluation,
this final rule revises the DLHS from 40
mg/ft2 and 250 mg/ft2 to 10 mg/ft2 and 100
mg/ft2 on floors and window sills,
respectively. EPA is also finalizing its
proposal to make no change to the
definition of LBP because insufficient
information exists to support such a
change at this time.
DATES: This final rule is effective
January 6, 2020.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2018–0166, is
available at https://www.regulations.gov
or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket),
Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
SUMMARY:
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• 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.
• Real estate (NAICS code 531), e.g.,
lessors of residential buildings and
dwellings, residential property
managers.
• Child day care services (NAICS
code 624410).
• Elementary and secondary schools
(NAICS code 611110), e.g., elementary
schools with kindergarten classrooms.
• Other technical and trade schools
(NAICS code 611519), e.g., training
providers.
• Engineering services (NAICS code
541330) and building inspection
services (NAICS code 541350), e.g., dust
sampling technicians.
• Lead abatement professionals
(NAICS code 562910), e.g., firms and
supervisors engaged in LBP activities.
• Testing laboratories (NAICS code
541380) that analyze dust wipe samples
for lead.
• Federal agencies that own
residential property (NAICS code 92511,
92811).
• Property owners, and property
owners that receive assistance through
federal housing programs (NAICS code
531110, 531311).
B. What is the Agency’s authority for
taking this action?
EPA is finalizing this rule under
sections 401, 402, 403, and 404 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). 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
(15 U.S.C. 2681), LBP hazards are
defined as conditions of LBP and leadcontaminated dust and soil that ‘‘would
result in adverse human health effects,’’
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. . . .’’ As defined
in TSCA section 401 (15 U.S.C. 2681(9)),
LBP means paint or other surface
coatings that contain lead in excess of
1.0 milligrams per centimeter squared or
0.5 percent by weight or (1) in the case
of paint or other surface coatings on
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target housing, such lower level as may
be established by HUD, as defined in 42
U.S.C. 4822(c), or (2) in the case of any
other paint or surface coatings, such
other level as may be established by
EPA.
The amendments to the regulations on
LBP activities are promulgated pursuant
to TSCA section 402 (15 U.S.C 2682).
The amendments to the regulations on
the authorization of state and tribal
Programs are finalized pursuant to
TSCA section 404 (15 U.S.C. 2684).
This final rule is being issued in
compliance with the December 27, 2017
decision (‘‘Opinion’’) of the Ninth
Circuit Court of Appeals, and the
subsequent March 26, 2018 order that
directed the EPA ‘‘to issue a proposed
rule within ninety (90) days from the
filed date of this order,’’ and to
‘‘promulgate the final rule within one
year after the promulgation of the
proposed rule’’ (Refs. 2 and 3).
C. What action is the Agency taking?
EPA established DLHS of 40 mg/ft2 for
floors and 250 mg/ft2 for window sills in
a final rule entitled, ‘‘Identification of
Dangerous Levels of Lead,’’ also known
as the 2001 LBP Hazards Rule (Ref. 4).
On July 2, 2018, EPA proposed to
amend the DLHS and to make no change
to the definition of LBP (Ref. 5). EPA is
finalizing its proposal to lower the
DLHS set by the LBP Hazards Rule from
40 mg/ft2 to 10 mg/ft2 for floors, and from
250 mg/ft2 to 100 mg/ft2 for window sills.
EPA and HUD adopted the statutory
definition of LBP in a joint final rule
entitled, ‘‘Requirements for Disclosure
of Known Lead-Based Paint and/or
Lead-Based Paint Hazards in Housing,’’
also known as the Disclosure Rule (Ref.
6). EPA is finalizing its proposal to
make no change to the current
definition of LBP because, as further
explained in Unit III.B, insufficient
information exists to support such a
change at this time.
D. Why is the Agency taking this action?
Reducing childhood lead exposure is
an EPA priority, and EPA continues to
collaborate with our federal partners to
reduce lead exposures and to explore
ways to strengthen our relationships
and partnerships with states, tribes, and
localities. 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 (Lead Action Plan) (Ref. 7)
which will enhance the federal
government’s efforts to identify and
reduce lead exposure while ensuring
children impacted by such exposure are
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getting the support and care they need.
The Lead Action Plan will help federal
agencies work strategically and
collaboratively to reduce exposure to
lead and improve children’s health.
This final rule is a component of EPA’s
prioritizing the important issue of
childhood lead exposure because dust is
a significant exposure route for young
children because of their mouthing
behavior and proximity to the floor.
In the 2001 LBP Hazards Rule under
TSCA section 403, EPA modeled the
health implications of various dust-lead
loadings and analyzed those values
against issues of practicality to
determine the appropriate standards, in
accordance with the statute. At that
time, the Centers for Disease Control
and Prevention (CDC) identified a test
result of 10 mg/dL of lead in blood or
higher in children as a ‘‘level of
concern’’. Based on the available
science at the time, EPA explained that
health effects at blood lead levels (BLLs)
lower than 10 mg/dL were ‘‘less well
substantiated.’’ Further, the Agency
acknowledged that the standards were
‘‘based on the best science available to
the Agency,’’ and if new data were to
become available, EPA would ‘‘consider
changing the standards to reflect these
data.’’ (Ref. 4)
New data have become available since
the 2001 LBP Hazards Rule that
indicates that health risks exist at lower
BLLs than previously recognized. The
CDC now considers that no safe BLL in
children has been identified (Ref. 8), is
no longer using the term ‘‘level of
concern,’’ and is instead using the blood
lead reference value (BLRV) to identify
children who have been exposed to lead
and who should undergo case
management (especially assessment of
sources of lead in their environment and
follow up BLL testing) (Ref. 8). The
BLRV is based on the 97.5th percentile
of the U.S. population distribution of
BLLs in children ages 1–5 from the
2007–2008 and 2009–2010 National
Health and Nutrition Examination
Surveys (Ref. 9).
Current best available science, which,
as indicated above, has evolved
considerably since 2001, informs EPA’s
understanding of the relationship
between exposures to dust-lead
loadings, blood lead levels, and risk of
adverse human health effects. This is
summarized in the Integrated Science
Assessment for Lead, (‘‘Lead ISA’’) (Ref.
10), which EPA released in June 2013,
and the National Toxicology Program
(NTP) Monograph on Health Effects of
Low-Level Lead, which was released by
the Department of Health and Human
Services in June 2012 (Ref. 11). The
Lead ISA is a synthesis and evaluation
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of scientific information on the health
and environmental effects of lead,
including health effects of BLLs lower
than 10 mg/dL. These effects include
cognitive function decrements in
children (Ref. 10).
The NTP, in 2012, completed an
evaluation of existing scientific
literature to summarize the scientific
evidence regarding potential health
effects associated with low-level lead
exposure as indicated by BLLs less than
10 mg/dL. The evaluation specifically
focused on the life stage (childhood,
adulthood) associated with these
potential health effects, as well as on
epidemiological evidence at BLLs less
than 10 mg/dL, because health effects at
higher BLLs are well-established. The
NTP concluded that there is sufficient
evidence for risk of adverse health
effects in children and adults at BLLs
less than 10 mg/dL, and less than 5 mg/
dL as well. In children, there is
sufficient evidence that BLLs less than
5 mg/dL are associated with increased
diagnoses of attention-related behavioral
problems, greater incidence of problem
behaviors, and decreased cognitive
performance. There is limited evidence
that BLLs less than 5 mg/dL are
associated with delayed puberty and
decreased kidney function in children
12 years of age and older. Additionally,
the NTP concluded that there is
sufficient evidence that BLLs less than
10 mg/dL are associated with delayed
puberty, decreased hearing, and reduced
post-natal growth (Ref. 11).
Furthermore, the Children’s Health
Protection Advisory Committee
(CHPAC), a Federal Advisory
Committee for EPA, has recommended
‘‘that EPA, in coordination with HUD,
make strengthening the Lead-Based
Paint Hazards Standards for paint, dust,
and soil one of its highest priorities in
the efforts to reduce children’s blood
lead levels.’’ (Refs. 12 and 13).
Based on EPA’s evaluation of the best
available science, the Agency’s careful
review of public comments received on
the proposal, as well as consideration of
the potential for risk reduction,
including whether such actions are
achievable, EPA is finalizing its
proposal to revise the DLHS to 10 mg/
ft2 for floors and 100 mg/ft2 for window
sills. This final action is informed by the
achievability of these standards in
relation to their application in lead risk
reduction programs, whether lower
dust-lead loadings can be reliably
detected by laboratories, resources for
addressing LBP hazards, and
consistency across the federal
government.
EPA did not propose to change postabatement clearance levels in 40 CFR
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part 745, subpart L. In this regard, EPA
believes it has reasonably focused this
rulemaking on the DLHS and the
definition of LBP, which are the two
actions EPA agreed to undertake in
response to the 2009 citizen petition.
They were also the two actions
expressly addressed in the Ninth Circuit
Court of Appeals Opinion discussed
above. Nonetheless, while this final rule
does not address clearance levels, EPA
appreciates the points raised by
commenters about the relationship
between the DLHS and clearance levels
and EPA has initiated action on this
issue under a separate rulemaking,
entitled ‘‘Review of Post-Abatement
Clearance Levels for Dust-lead’’ (RIN
2070–AK50), as noted in the Spring
2019 Unified Agenda of Regulatory and
Deregulatory Actions. The Spring 2019
Unified Agenda also presents EPA’s
anticipated publication timelines for the
rulemaking that will address the
clearance levels.
To update the dust-lead clearance
levels, EPA must take a number of steps
including health, exposure, and
economic analyses. An analysis
estimating the health implications of
possible revisions of applicable dustlead clearance levels will be conducted,
taking into account factors such as the
locations where clearance samples are
collected for each of the various
candidate clearance levels under
consideration. An economic analysis of
candidate dust-lead clearance levels
will be conducted for purposes of
evaluating the potential costs and
benefits of possible revisions to the
clearance levels. EPA’s economic
analysis will involve establishing a
baseline lead hazard profile for facilities
affected by the rule based on knowledge
of any applicable existing rules and
standards and levels of compliance with
those rules and standards. Candidate
clearance levels will then need to be
analyzed with reference to this baseline.
For this purpose, economic modeling
will be performed to link each candidate
clearance level to the associated
scenario of health endpoints and their
associated aggregated ‘‘benefit’’
valuations for the whole affected
population. On the cost side, using
assumptions about the scope of
interventions, scenarios will be
developed to measure aggregate costs of
compliance for each candidate clearance
level. In addition, the economic analysis
is required in order to comply with the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1531–1538), and the Congressional
Review Act (CRA) (5 U.S.C. 801 et seq.).
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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. 14). The analysis focused
specifically on the subset of target
housing and child-occupied facilities
affected by this rule. The analysis
estimates incremental costs and benefits
for two categories of events: (1) Where
dust-lead testing occurs to comply with
HUD’s Lead-Safe Housing Rule and (2)
where dust-lead testing occurs in
response to testing that detects an
elevated blood lead level in a child. The
following is a brief outline of the
estimated incremental impacts of this
rulemaking.
• Benefits. This rule would reduce
exposure to lead, resulting in benefits
from avoided adverse health effects. For
the subset of adverse health effects
where the results were quantified, the
estimated annualized benefits are $268
million to $2.3 billion per year using a
3% discount rate, and $58 million to
$509 million using a 7% discount rate.
These benefits calculations are highly
sensitive to the discount rate used and
to the range in the estimated number of
lead hazard reduction events triggered
by the blood lead levels in children who
have had their blood lead levels tested.
With respect to the latter, the wide
range is driven by uncertainty about
specifics of state and local regulations
and about the blood lead levels at which
action might be taken. There are
additional unquantified benefits due to
other avoided adverse health effects in
children, including attention-related
behavioral problems, greater incidence
of problem behaviors, decreased
cognitive performance, reduced postnatal growth, delayed puberty and
decreased kidney function (Ref. 11).
• Costs. This rule is estimated to
result in costs of $32 million to $117
million per year using either a 3% or
7% discount rate. The cost calculations
are highly sensitive to the range in the
estimated number of lead hazard
reduction events triggered by children
with elevated blood lead levels.
• Small entity impacts. This rule
would impact approximately 15,400
small businesses of which 96% have
cost impacts less than 1% of revenues,
4% have impacts between 1% and 3%,
and less than 1% have impacts greater
than 3% of revenues.
• Environmental Justice and
Protection of Children. This rule would
increase the level of environmental
protection for all affected populations
without having any disproportionately
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high and adverse human health or
environmental effects on any
population, including any minority or
low-income population or children.
• Effects on State, local, and Tribal
governments. The rule would not have
any significant or unique effects on
small governments, or federalism or
tribal implications.
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F. Children’s Environmental Health
Lead exposure has the potential to
impact individuals of all ages, but it is
especially harmful to young children
(Refs. 15, 16 and 17). Exposure to lead
is associated with increased risk of a
number of adverse health effects in
children, including decreased cognitive
performance, greater incidence of
problem behaviors, and increased
diagnoses of attention-related behavioral
problems (Ref. 11). Furthermore, floor
dust in homes and child-care facilities
is a significant route of exposure for
children given their mouthing behavior
and proximity to the floor. Therefore,
the environmental health or safety risk
addressed by this action may have a
disproportionate effect on children (Ref.
18).
Consistent with the Agency’s Policy
on Evaluating Health Risks to Children,
EPA has evaluated the health effects in
children of decreased lead exposure.
EPA prepared a Technical Support
Document (TSD) for this rulemaking
which models the risk of adverse health
effects associated with dust-lead
exposures at 19 potential candidate
standards for dust-lead levels (Ref. 18).
It is important to note that the model
and input parameters have been the
subject of multiple Science Advisory
Board Reviews, workshops and
publications in the peer reviewed
literature. The TSD shows that health
risks to young children decrease with
decreasing dust-lead levels but that no
non-zero lead level, including
background levels, can be shown to
eliminate health risk entirely.
Therefore, EPA considered additional
factors beyond health effects when
selecting a new standard, including
achievability of the standards in lead
risk reduction programs, whether lower
dust-lead loadings can be reliably
detected by laboratories, resources for
addressing LBP hazards, and
consistency across the federal
government. Additional information on
EPA’s evaluation can be found in Unit
III.A.2 of this preamble. On the basis of
all these factors (including health
effects), EPA is finalizing its proposal to
lower the DLHS set by the LBP Hazards
Rule to 10 mg/ft2 for floors and 100 mg/
ft2 for window sills.
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II. Background
A. Health Effects
Lead exposure has the potential to
impact individuals of all ages, but it is
especially harmful to young children
(Refs. 15, 16 and 17). Ingestion of leadcontaminated soil and dust is a major
contributor to BLLs in children,
particularly those who reside in homes
built prior to 1978 (Refs. 19 and 20).
Infants and young children can be more
highly exposed to lead through floor
dust at home and in child-care facilities
because they often put their hands and
other objects that can have lead from
dust or soil on them into their mouths
(Ref. 17). As mentioned elsewhere in
this final rule, data evaluated by the
NTP demonstrates that there is
sufficient evidence to conclude that
there are adverse health effects
associated with low-level lead exposure;
there is sufficient evidence that, in
children, BLLs less than 5 mg/dL are
associated with increased diagnoses of
attention-related behavioral problems,
greater incidence of problem behaviors,
and decreased cognitive performance
(Ref. 11). For further information about
health effects and lead exposure, see the
Lead ISA (Ref. 10).
B. Federal Actions To Reduce Lead
Exposures
In 1992, Congress enacted 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) (Ref.
1) in an effort to eliminate LBP hazards.
Section 1018 of Title X required EPA
and HUD to promulgate joint
regulations for disclosure of any known
LBP or any known LBP hazards in target
housing offered for sale or lease (known
as the Disclosure Rule) (Ref. 6). (‘‘Target
housing’’ is defined in section 401(17)
of TSCA, 15 U.S.C. 2681(17)). On March
6, 1996, the Disclosure Rule was
codified at 40 CFR part 745, subpart F,
and requires information disclosure
activities before a purchaser or lessee is
obligated under a contract to purchase
or lease target housing. Title X amended
TSCA to add a new subchapter entitled
‘‘Title IV—Lead Exposure Reduction.’’
As defined in TSCA section 401 (15
U.S.C. 2681(9)), LBP means paint or
other surface coatings that contain lead
in excess of 1.0 milligrams per
centimeter squared or 0.5 percent by
weight or (1) in the case of paint or
other surface coatings on target housing,
such lower level as may be established
by HUD, as defined in 42 U.S.C. 4822(c),
or (2) in the case of any other paint or
surface coatings, such other level as may
be established by EPA.
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This definition was codified as part of
the Disclosure Rule (Ref. 6) at 40 CFR
part 745, subpart F, and as part of the
LBP Activities Rule (Ref. 21) at 40 CFR
part 745, subpart L. TSCA section 402(a)
directs EPA to promulgate regulations
covering LBP activities to ensure
persons performing these activities are
properly trained, that training programs
are accredited, and that contractors
performing these activities are certified.
On August 29, 1996, EPA published
final regulations under TSCA section
402(a) that govern LBP inspections, risk
assessments, and abatements in target
housing and child occupied facilities
(COFs) (also referred to as the LBP
Activities Rule, codified at 40 CFR part
745, subpart L) (Ref. 21). The definition
of ‘‘child-occupied facility’’ is codified
at 40 CFR 745.223 for purposes of LBP
activities. Regulations promulgated
under TSCA section 402(a) contain
standards for performing LBP activities,
taking into account reliability,
effectiveness, and safety.
TSCA section 402(c)(3) directs EPA to
promulgate regulations covering
renovation or remodeling activities in
target housing, public buildings
constructed before 1978, and
commercial buildings that create LBP
hazards. EPA promulgated final
regulations for target housing and COFs
in the Lead Renovation, Repair and
Painting Rule, under TSCA section
402(c)(3) on April 22, 2008 (also
referred to as the RRP Rule, codified at
40 CFR part 745, subpart E) (Ref. 22).
The rule was amended in 2010 (75 FR
24802) (Ref. 23) to eliminate a provision
for contractors to opt-out of prescribed
work practices and in 2011 (76 FR
47918) (Ref. 24) to affirm the work
practice requirements for cleaning
verification of renovated or repaired
spaces, among other things. For further
information regarding lead and its
health effects, and federal actions taken
to eliminate LBP hazards in housing, see
the background section of the RRP Rule.
TSCA section 403 is a related
authority to carry out responsibilities for
addressing LBP hazards under the
Disclosure and LBP Activities Rules.
Section 403 required EPA to promulgate
regulations that ‘‘identify . . . leadbased paint hazards, lead-contaminated
dust, and lead-contaminated soil’’ for
purposes of TSCA Title IV and the
Residential Lead-Based Paint Hazard
Reduction Act of 1992. LBP hazards,
under TSCA section 401, are defined as
conditions of LBP and leadcontaminated dust and soil that ‘‘would
result’’ in adverse human health effects
(15 U.S.C. 2681(10)). TSCA section 401
defines lead-contaminated dust as
‘‘surface dust in residential dwellings’’
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that contains lead in excess of levels
determined ‘‘to pose a threat of adverse
health effects’’ (15 U.S.C. 2681(11)). The
standards established in today’s final
rule under TSCA section 403 are used
to calibrate activities carried out under
TSCA section 402. As such, the utility
of these standards should be considered
in the context of the activities to which
they are applied.
Pursuant to TSCA section 404,
provisions were made for interested
states, territories, and tribes to apply for
and receive authorization to administer
their own LBP Activities and RRP
programs. Requirements applicable to
state, territorial, and tribal programs are
codified in 40 CFR part 745, subpart Q.
As stated elsewhere in this document,
EPA’s regulations are intended to
reduce exposures and to identify and
mitigate hazardous levels of lead.
Authorized programs must be ‘‘at least
as protective of human health and the
environment as the corresponding
federal program,’’ and must provide for
‘‘adequate enforcement.’’ See 40 CFR
745.324(e)(2).
HUD’s Lead Safe Housing Rule
(LSHR) is codified in 24 CFR 35,
subparts B through R. The LSHR
implements sections 1012 and 1013 of
Title X. Under Title X, HUD has specific
authority to control LBP and LBP
hazards in federally-assisted target
housing (including COFs that are part of
an assisted target housing property
covered by the LSHR, because they are
part of the common area of the
property). The LSHR aims in part to
ensure that federally-owned or
federally-assisted target housing is free
of LBP hazards (Ref. 25). Under the
LSHR, when a child under age six (6)
with an elevated blood lead level (EBLL)
is identified, the ‘‘designated party’’
and/or the housing owner shall
undertake certain actions.
HUD amended the LSHR in 2017,
lowering its standard for identifying
children with EBLLs from 20 mg/dL to
5 mg/dL, aligning its standard with
CDC’s BLRV. The amendments also
included revising HUD’s
‘‘Environmental Investigation Blood
Lead Level’’ (EIBLL) to the EBLL,
changing the level of investigation
required for a housing unit of a child
with an EBLL to an ‘‘environmental
investigation’’ and adding a requirement
for testing in other covered units when
a child is identified in a multiunit
property. HUD may revisit and revise
the agency’s EBLL via the notice and
comment process, as provided by the
definition of EBLL in the amended rule,
if it is appropriate to do so in order to
align with future changes to the blood
lead level at which CDC’s BLRV
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recommends that an environmental
intervention be conducted. (Ref. 25).
C. Applicability and Uses of the DLHS
The DLHS reviewed in this regulation
support the Lead-based Paint Activities
and Disclosure programs, and apply to
target housing (i.e., most pre-1978
housing) and COFs (pre-1978 nonresidential properties where children
under the age of 6 spend a significant
amount of time such as daycare centers
and kindergartens). Apart from COFs,
no other public and commercial
buildings are covered by this final rule.
For further background on the types of
buildings to which lead program rules
apply, refer to the proposed and final
LBP Hazards Rule (Ref. 4).
Within the scope of Title X, the DLHS
support and implement major
provisions of the statute. They were
incorporated into the requirements and
risk assessment work practice standards
in the LBP Activities Rule. The
relationship between post-abatement
clearance and the DLHS is discussed in
further detail elsewhere in this final
rule. The DLHS provide the basis for
risk assessors to determine whether
dust-lead hazards are present. A risk
assessment may be required where dustlead testing occurs to comply with the
LSHR or where dust-lead testing occurs
in response to discovery of a child with
a blood lead level exceeding a federal or
state threshold.
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. If LBP hazards are found,
the risk assessor will also identify
acceptable options for controlling the
hazards in each property. These options
should allow the property owner to
make an informed decision about what
actions should be taken to protect the
health of current and future residents.
Risk assessments can only be performed
by certified risk assessors.
The risk assessment entails both a
visual assessment and collection of
environmental samples. The
environmental samples include, among
other things, dust samples from floors
and window sills which are sent to a
laboratory recognized by EPA’s National
Lead Laboratory Accreditation Program
(NLLAP), as discussed in section III.A.2
for analysis for lead. When the lab
results are received, the risk assessor
compares them to the DLHS. If the dustlead loadings from the samples are at or
above the applicable DLHS, then a dustlead hazard is present. Any LBP hazards
found are listed in a report prepared for
the property owner by the risk assessor.
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For the Disclosure Rule under section
1018 of Title X (42 U.S.C. 4852d), EPA
and HUD jointly developed regulations
requiring a seller or lessor of most pre1978 housing to disclose the presence of
any known LBP and LBP hazards to the
purchaser or lessee (24 CFR part 35,
subpart A; 40 CFR part 745, subpart F).
Under these regulations, the seller or
lessor also must provide the purchaser
or lessee any available records or reports
‘‘pertaining to’’ LBP, LBP hazards
and/or any lead hazard evaluation
reports available to the seller or lessor
(40 CFR 745.107(a)(4) and 24 CFR
35.88(a)(4)). Accordingly, if a seller or
lessor has a report showing lead is
present in levels that would not
constitute a hazard, that report must
also be disclosed. Thus, disclosure is
required under section 1018 even if dust
and soil levels are less than the
applicable LBP hazard standard. EPA
notes, however, that with respect only
to leases of target housing, disclosure is
not required in the limited circumstance
where the housing has been found to be
LBP free by a certified inspector (24 CFR
35.82; 40 CFR 745.101).
D. Limitations of the DLHS
The DLHS are intended to identify
dust-lead hazards when LBP risk
assessments are performed. These
standards, as were those established in
2001, are for the purposes of Title X and
TSCA Title IV, and therefore they do not
apply to housing and COFs built during
or after 1978, nor do they apply to pre1978 housing that does not meet the
definition of target housing. See 40 CFR
745.61. These standards cannot be used
to identify housing that is free from
risks from exposure to lead, 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 increased risk
of exposure. If one chooses to apply the
DLHS to situations beyond the scope of
Title X, care must be taken to ensure
that the action taken in such settings is
appropriate to the circumstances
presented in that situation, and that the
action is adequate to provide any
necessary protection for children
exposed.
The DLHS do not require the owners
of properties covered by this final rule
to evaluate their properties for the
presence of dust-lead hazards, or to take
action if dust-lead hazards are
identified. Although these regulations
do not compel specific actions to
address identified LBP hazards, these
standards are incorporated into certain
requirements mandated by state, federal,
tribal, and local governments. An
important concern for EPA is that if the
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DLHS were set too low, the resources for
LBP hazard mitigation would be
distributed more broadly, diverting
them from situations that present more
serious risks. However, EPA does not
believe that the levels in this final rule
constrict these programs, considering
the demonstrated achievability of these
levels (Ref. 26). As such, these standards
are appropriate for incorporation into
the various assessment and LBP hazard
control activities to which they apply.
E. Administrative Petition and Litigation
On August 10, 2009, EPA received an
administrative petition from several
environmental and public health
advocacy groups requesting that EPA
amend regulations issued under Title IV
of TSCA (Ref. 27). The petitioners
requested that EPA lower the Agency’s
DLHS issued pursuant to section 403 of
TSCA, and the dust-lead clearance
levels issued pursuant to section 402 of
TSCA, from 40 mg/ft2 to 10 mg/ft2 or less
for floors, and from 250 mg/ft2 to 100 mg/
ft2 or less for window sills; and to lower
the definition of LBP pursuant to
section 401 of TSCA from 1 mg/cm2 and
0.5 percent by weight, to 0.06 percent by
weight with a corresponding reduction
in units of mg/cm2.
On October 22, 2009, EPA responded
to this petition pursuant to section
553(e) of the Administrative Procedure
Act (5 U.S.C. 553(e)) (EPA 2009) (Ref.
28). EPA agreed to commence an
appropriate proceeding on the DLHS
and the definition of LBP in response to
the petition, but stated that it did not
commit to a particular schedule or to a
particular outcome.
In August 2016, administrative
petitioners—joined by additional citizen
groups—filed a petition for writ of
mandamus in the Ninth Circuit Court of
Appeals, seeking a court order finding
that EPA had unreasonably delayed in
promulgating a rule to update the DLHS
and the definition of LBP under TSCA
and directing EPA to promulgate a
proposed rule within 90 days, and to
finalize a rule within six months. On
December 27, 2017, a panel majority of
the Ninth Circuit granted the writ of
mandamus and ordered that EPA (1)
issue a proposed rule within ninety
days of the date the decision becomes
final and (2) issue a final rule one year
thereafter (Ref. 2). On March 26, 2018,
the Panel granted EPA’s Motion for
Clarification, specifying that the
proposed rule was due ninety days from
the date of that order (Ref. 3). On June
22, 2018, the EPA Administrator signed
and EPA announced its proposed rule to
lower the DLHS to 10 mg/ft2 for floors
and 100 mg/ft2 for window sills and to
make no change to the definition of
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lead-based paint due to a lack of
sufficient information to support such a
change. (Ref. 29). The proposed rule was
published in the July 2, 2018 edition of
the Federal Register.
EPA is issuing this final rule in
compliance with the Court’s order.
Notably, the Court’s majority decision
suggested that EPA had already
determined that amending these
regulations was necessary pursuant to
TSCA (15 U.S.C. 2687). However, EPA
stated in its 2009 petition response that
‘‘the current hazard standards may not
be sufficiently protective’’ (Ref. 28)
(emphasis added). With regard to the
definition of LBP, EPA had not even
opined that the definition may not be
sufficiently protective. Rather,
throughout the litigation, EPA
maintained that it would consider
whether revision of the definition was
appropriate. Also, the sufficiency of the
standards was not at issue, as this
mandamus petition was about timing,
not substance and EPA had not
previously conducted the analyses
required to reach a conclusion under the
statutory standard. It was not until EPA
conducted its own analyses—during
this rulemaking process—that it was in
a position to express the conclusions
that are set forward in this final rule.
F. Public Comments Summary
The proposed rule provided a 45-day
public comment period, ending on
August 16, 2018. EPA received 67
comments during the public comment
period. After the close of the public
comment period, EPA received an
additional 13,376 comments nearly all
of which were submitted as part of a
mass mail campaign. Comments were
received from private citizens, state
governments, potentially affected
businesses, academics, trade
associations, and environmental and
public health advocacy groups. Many
commenters, including states, LBP
businesses, lead poisoning prevention
advocacy groups, individuals, and
academics, supported revising the DLHS
as proposed. A number of commenters
suggested that EPA should promulgate
DLHS lower than the proposed levels at
10 mg/ft2 for floors, and 100 mg/ft2 for
window sills. Several commenters
specifically suggested that EPA should
revise the DLHS for floors to 5 mg/ft2,
and/or 40 mg/ft2 for window sills. One
commenter suggested that EPA should
revise the DLHS only if the clearance
levels are revised as well. Other
commenters suggested that EPA either
not revise the DLHS or revise them to
levels higher than those in today’s final
rule. Another commenter expressed
concern with a DLHS of 10 mg/ft2 for
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floors, contending that this would
increase the cost of the HUD Lead
Hazard Control (LHC) grant program
due to an increase in clearance failures.
Several commenters sought clarity in
terms of how a potential revision to the
DLHS would affect LBP-related
activities that had already taken place or
were in the process of conducting lead
hazard control activities. 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 can be found in the
Response to Comments document (Ref.
30).
III. Final Rule
EPA carefully considered all public
comments related to the proposal. EPA
is finalizing its proposal to lower the
DLHS for floors from 40 mg/ft2 to 10 mg/
ft2 and its proposal to lower the DLHS
for window sills from 250 mg/ft2 to 100
mg/ft2.
This rule finalizes EPA’s proposal to
make no change to the definition of LBP
because insufficient information exists
to support such a change at this time.
A. Dust-Lead Hazard Standards
1. Approach for reviewing the dustlead hazard standards. As EPA
explained in the 2001 LBP Hazards Rule
(Ref. 4) (66 FR 1206, 1207), one of the
underlying principles of Title X is to
move the focus of public and private
sector decision makers away from the
mere presence of LBP, to the presence
of LBP hazards, for which more
substantive action should be undertaken
to control exposures, especially to
young children. Since there are many
sources of lead exposure (e.g. air, water,
diet, background levels of lead), and
since, under TSCA Title IV, EPA may
only account for risks associated with
paint, dust and soil, EPA continues to
believe that non-zero LBP hazard
standards are appropriate.
In the 2001 LBP Hazards Rule, EPA
explained the issues and inherent
discretion involved when the
Administrator identifies LBP hazards
(i.e., those conditions that cause
exposure to lead ‘‘that would result in
adverse human health effects as
established by the Administrator under
this subchapter’’ (TSCA section
401(10))). Of particular note, EPA
explained that the challenge to the
Agency is how to deal with the statutory
criterion, ‘‘would result in adverse
human health effects.’’ This is
especially problematic because the
statutory mandated activity that requires
EPA to choose a cutoff for when this
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risk exists does not lend itself to a
straightforward empirical analysis that
provides bright lines for decision
makers. 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, it would not be
appropriate to base a lead-based paint
hazard standard on any specific
probability of exceeding any specific
blood-lead level. (Ref. 4).
As further explained in that 2001 LBP
Hazards Rule, EPA first determined the
lowest candidate DLHS by using a 1–5%
probability of an individual child
developing a BLL of 10 mg/dL. EPA then
took a pragmatic approach by looking at
numerous factors affected by the
candidate standards and prioritized
protection from the greatest lead risks so
as not to dilute intervention resources.
To develop the DLHS proposal in
2018 (Ref. 5), EPA evaluated the
relationship between dust-lead levels
and children’s health, and considered
the achievability of the DLHS given the
relationship between standards
established under TSCA section 403 and
the application of those standards in
lead risk reduction programs.
Additional factors that the Agency
considered include whether lower dustlead loadings can be reliably detected by
laboratories, resources for addressing
LBP hazards, and consistency across the
federal government.
The TSD presents models to
determine the risk of adverse health
effects associated with dust-lead
exposures at 19 levels (Ref. 18). Section
6.4 of the TSD summarizes the results
of the metrics of interest, including the
probability that an individual exposed
to each potential candidate standard
would have a BLL above 5 mg/dL.
Consistent with the establishment of
the 2001 DLHS, EPA believes national
standards are still an appropriate
regulatory approach because they
facilitate implementation and decrease
uncertainty within the regulated
community. Furthermore, national
standards are appropriate because
legacy lead paint remains in homes in
most, if not all, parts of the country. For
further information, see the LBP
Hazards Rule (Ref. 4).
Based on the language of sections 401,
402, and 403 of TSCA and the purposes
of Title X and its legislative history,
EPA continues to believe that it is a
reasonable exercise of its discretion to
set hazard standards based on
consideration of the potential for risk
reduction, including whether such
actions are achievable, and with
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consideration given to the existing
programs aimed at achieving such
reductions. This final rule revising the
DLHS to 10 mg/ft2 for floors and 100 mg/
ft2 for window sills is informed by the
achievability of these standards in
relation to their application in lead risk
reduction programs, whether lower
dust-lead loadings can be reliably
detected by laboratories, resources for
addressing LBP hazards, and
consistency across the federal
government. In this final rule, the
Administrator is exercising his
Congressionally delegated function to
identify LBP hazards, which the statute
defines as those conditions that cause
exposure to lead ‘‘that would result in
adverse human health effects as
established by the Administrator,’’ in
light of the data and associated
uncertainties and the statutory purpose
of targeting intervention resources
towards protection against the greatest
lead risks.
EPA’s hazard standards should not be
considered in isolation, but must be
contemplated along with the Agency’s
actions to address lead in other media.
It is anticipated that this final rule,
especially in conjunction with other
federal actions, will result in better
health outcomes for children. As
described in the DLHS proposal in 2018
(Ref. 5), scientific advances made since
the promulgation of the 2001 rule
clearly demonstrate that exposure to
low levels of lead result in adverse
health effects. Moreover, since CDC has
stated that no safe level of lead in blood
has been identified, the reductions in
children’s BLLs as a result of this rule
will help reduce the risk of adverse
cognitive and developmental effects in
children.
2. Selection of final DLHS. Reducing
childhood lead exposure is an EPA
priority, and today’s final rule is one
component of EPA’s broad effort to
reduce children’s exposure to lead.
While no safe level of lead in blood has
been identified (Ref. 8), the reductions
in children’s blood-lead levels resulting
from this rule are expected to reduce the
risk of adverse cognitive and
developmental effects in children.
TSCA Section 403 required EPA to
promulgate regulations that ‘‘identify
. . . lead-based paint hazards, leadcontaminated dust, and leadcontaminated soil’’ for purposes of
TSCA Title IV and the Residential LeadBased Paint Hazard Reduction Act of
1992. LBP hazards, under TSCA section
401, 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)).
TSCA section 401 defines lead-
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contaminated dust 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)).
In selecting the DLHS, EPA gave
significant weight to health outcomes
identified in the TSD. As the TSD
shows, health risks to young children
decrease with decreasing dust-lead
levels; incremental decreases to BLL
and adverse health effects are seen at all
points below the original DLHS
established in 2001. Although 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. Therefore, it is appropriate for
EPA to consider factors beyond health
effects when selecting new standards.
Additional factors that the Agency
considered include achievability of the
standards in lead risk reduction
programs, whether lower dust-lead
loadings can be reliably detected by
laboratories, resources for addressing
LBP hazards, and consistency across the
federal government.
EPA is concerned that if DLHS were
set too low, the limited resources for
hazard mitigation would be distributed
more broadly, diverting them from
vulnerable communities or situations
that present more serious risks to those
that present lower risks. As described in
the Key Federal Programs to Reduce
Childhood Lead Exposures and
Eliminate Associated Health Impacts
document, as well as the Lead Action
Plan, national data suggest disparities
persist among and within communities
due to factors such as race, ethnicity,
and income (Ref. 20). In 2013–2016, the
95th percentile BLL of children ages 1
to 5 years in families with incomes
below poverty level was 3.0 mg/dL
(median is 0.9 mg/dL,) and among those
in families at or above the poverty level
it was 2.1 mg/dL (median is 0.7 mg/dL),
a difference that is statistically
significant. In 2011–2016, 2.2% of
children in families below the poverty
level had a BLL at or above 5 mg/dL,
compared to 0.6% of children in
families at or above the poverty level, a
difference that is statistically significant.
The 97.5th percentile in 2013–2016 is
3.3 mg/dL, a slight decrease from the
value for 2011–2014 (Ref. 31).
As noted earlier in the preamble, EPA
continues to believe that it is a
reasonable exercise of its discretion to
set hazard standards based on
consideration of the potential for risk
reduction, including whether such
actions are achievable, and with
consideration given to the existing
programs aimed at achieving such
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reductions. Additional factors that the
Agency considered include whether
lower dust-lead loadings can be reliably
detected by laboratories, resources for
addressing LBP hazards, and
consistency across the federal
government. As discussed in Units I.D.
and II.A.2. of the proposal, EPA worked
with HUD’s Office of Lead Hazard
Control and Healthy Homes (OLHCHH)
to survey the office’s LHC grantees to
assess the achievability of candidate
DLHS (Ref. 26). Survey results showed
that reductions in dust-lead levels to 10
mg/ft2 on floors and to 100 mg/ft2 on
window sills were shown to be
technically achievable using existing
cleaning practices, even though, at the
time, the reductions had to be just down
to 40 and 250 mg/ft2, respectively. As
explained in the survey’s final report,
testing results were collected from 1,552
housing units treated by 98 grantees,
and included 7,211 floor and 4,893
window sill dust samples. The data
were analyzed to determine the
percentage of samples with dust-lead
loadings at or below various levels. For
floors, 72% of samples showed dustlead levels at or below 5 mg/ft2, 85%
were at or below 10 mg/ft2, 90% were at
or below 15 mg/ft2, and 94% were at or
below 20 mg/ft2. For window sills, 87%
of samples showed dust-lead levels at or
below 40 mg/ft2, 91% were at or below
60 mg/ft2, 96% were at or below 80 mg/
ft2, and 97% were at or below 100 mg/
ft2 (Ref. 26). This final rule revising the
DLHS to 10 mg/ft2 for floors and 100 mg/
ft2 for window sills is informed by the
achievability of these standards in
relation to their application in lead risk
reduction programs. These standards
will complement other federal actions
aimed at reducing lead exposures for all
children. EPA also believes that the
standards will continue to inform where
intervention resources should be
directed for children with higher
exposures. These are the lowest levels
that EPA believes are reliably achievable
using existing lead-hazard control
practices and that are aligned with the
clearance levels required under certain
HUD grant programs. As such, these
levels provide greater uniformity across
the federal government than other
options suggested by commenters and
provide consistency for the regulated
and public health communities.
EPA received a number of comments
during the public comment period
suggesting that EPA promulgate DLHS
lower than the proposed levels at 10 mg/
ft2 for floors and 100 mg/ft2 for window
sills. Several commenters specifically
suggested DLHS for floors at 5 mg/ft2,
and/or 40 mg/ft2 for window sills. In the
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TSD, EPA models the risk of adverse
health effects associated with dust-lead
exposures at differing potential
candidate standards (19 options) in
children living in pre-1940 and pre1978 housing, as well as associated
potential health effects in this
subpopulation. As explained in the
EPA’s proposal and section 3.2.3 of the
TSD, floors have a larger impact on
children’s exposure to dust lead than
sills because they take up more square
footage of the housing unit and children
spend more of their time in contact with
the floor rather than the sills.
Consequently, candidate standards that
reduce floor dust-lead loadings more
than sill dust-lead loadings have the
biggest impact on exposure because of
the greater likelihood and magnitude of
children’s exposure to floor dust-lead.
For example, a candidate standard of 40
mg/ft2 for floors and 100 mg/ft2 for
window sills is likely to be less effective
than a standard of 10 or 20 mg/ft2 for
floors and 250 mg/ft2 for window sills.
In addition, at least one study
suggests that dust-lead may
reaccumulate after LHC activities,
especially when cleaning and interim
controls are used, and therefore DLHS
levels lower than 100 mg/ft2 for window
sills (e.g., 40 mg/ft2) may not be
maintained over time, and would
therefore render a lower DLHS to be a
less effective indication of what
property owners and residents can do to
achieve a reduction in lead exposure
(Ref. 32).The study shows that after
cleaning the geometric mean dust-lead
level was 45 mg/ft2 and the median dustlead level was 57 mg/ft2, both of which
are slightly above commenters’
suggested window sill dust-lead level of
40 mg/ft2. But from six months through
six years post-intervention, the window
sill dust-lead levels were well above this
level. At six months the geometric mean
dust level was 105 mg/ft2 and the
median was 104 mg/ft2, which is much
closer to a DLHS for window sills at 100
mg/ft2, rather than 40 mg/ft2. These
results call into question whether
window sill levels at or below 40 mg/ft2
can be maintained over time with
routine cleaning practices, particularly
interim controls. These inconsistencies,
along with the other concerns discussed
in this preamble, are why EPA has
declined to select a lower DLHS for
window sills as suggested by the
commenters.
Dust sampling is a critical element of
the lead-based paint program because it
is how members of the public learn
whether dust-lead hazards are present
in their homes and properties. Dust
sampling is conducted by wiping a
representative surface of known area
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with a wet wipe and sending the wipe
to a laboratory for analysis. The
laboratory that conducts the analysis
must be recognized by EPA’s NLLAP.
See TSCA section 405(b), 15 U.S.C.
2685(b); 40 CFR 745.90(c)(1); 40 CFR
745.223; 40 CFR 745.227(f); 40 CFR
745.327(c). EPA’s NLLAP defines the
minimum requirements and abilities
that a laboratory must meet to attain
EPA recognition as an accredited lead
testing laboratory in the Laboratory
Quality System Requirements (LQSR)
(Ref. 33).
Several commenters expressed
concern about laboratories’ ability to
meet lower limits resulting from a
revision to the DLHS, and one
commenter went further to recommend
that EPA thoroughly examine
laboratories’ ability to accurately
measure at lower levels. Several
commenters specifically requested
DLHS for floors at 5 mg/ft2 and/or 40 mg/
ft2 for window sills. EPA agrees that a
thorough understanding of laboratories’
ability to meet lower LQSR limits as a
result of revised DLHS is important,
especially in consideration of
commenters’ suggestions for lower
DLHS than were proposed and finalized
in this rule. As indicated in the
proposed rule (Ref. 5), EPA continues to
believe in the importance of being able
to assess whether the dust-lead loadings
reflected in the revised DLHS can be
reliably measured by laboratories. If
NLLAP-recognized laboratories were
unable to demonstrate meeting the
LQSR requirements, then stakeholders
would be unable to use those
laboratories in conducting activities
required by EPA’s LBP program. Those
laboratories would either take actions to
meet the lower LQSR limits or
discontinue analysis of lead dust wipe
samples from their portfolio of services.
If too many laboratories were to
discontinue lead dust wipe analysis
from their portfolios, it could be
problematic for the regulated
community that conducts the sampling
(as well as residents, property owners,
and other stakeholders), in the form of
increased cost of analysis per sample,
increased waiting periods that make
testing for dust-lead hazards untenable,
or a combination of both. As the number
of NLLAP-recognized labs decrease, the
potential for risk reduction is
diminished.
In order to obtain a better
understanding of laboratories’
capabilities and capacity for dust wipe
analysis, EPA conducted
teleconferences with two accrediting
organizations (Refs. 34; 35; and 36), five
federally funded laboratories (Refs. 37;
38; 39; 40; and 41), and nine state or
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privately funded laboratories (Refs. 42;
43; 44; 45; 46; 47; 48; 49; and 50). The
clientele of the two accrediting
organizations represent 99% of the
laboratories recognized by NLLAP for
dust-lead testing. Fourteen
teleconferences with NLLAP-recognized
laboratories represent approximately
13% of the NLLAP-recognized
laboratories, and one of the privately
funded laboratory contacts with whom
EPA spoke is a parent company of
sixteen (or approximately 15%) NLLAPrecognized laboratories (Ref. 45). EPA
believes the accrediting organizations
and laboratories with which
teleconferences were held are
representative of NLLAP-recognized
laboratories. These teleconferences
further informed the discussion below,
which examines laboratory
requirements and laboratories’ ability to
meet those requirements, various
approaches by which laboratories can
meet the lower LQSR limits, and how
the viability of those approaches
changes according to the DLHS in this
final rule and why revised DLHS below
those levels would impair the potential
for risk reduction.
EPA established NLLAP to recognize
laboratories that demonstrate the ability
to accurately analyze paint chips, dust,
or soil samples for lead. NLLAPrecognized laboratories must follow
EPA’s LQSR which identifies the limits
laboratories must achieve (Ref. 33). All
NLLAP-recognized laboratories are
required to demonstrate they can
achieve a quantitation limit and a
method detection limit (Ref. 33), and
accrediting organizations must use the
LQSR when evaluating laboratories
performing environmental testing
activities under NLLAP. A quantitation
limit, also known as a reporting limit
(Ref. 5) or minimum reporting limit
(Ref. 51), is the minimum level or
quantity of lead ‘‘that can be quantified
to a specified accuracy.’’ (Ref. 33) A
method detection limit is ‘‘[t]he
minimum concentration of [lead] that
. . . has a 99% probability of being
identified, qualitatively or
quantitatively measured, and reported
to be greater than zero.’’ (Ref. 33)
NLLAP-recognized laboratories that
analyze dust wipe samples for lead must
show they can achieve a quantitation
limit ‘‘equal to or less than . . . 50% of
the lowest action level [i.e., regulatory
limit] for dust wipe samples.’’ (Ref. 33)
The quantitation limit must also be ‘‘at
least 2 times but no greater than 10
times the method detection limit.’’ (Ref.
33) When this final rule becomes
effective, the ‘‘lowest action level for
dust wipe samples’’ will be the DLHS
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for floors at 10 mg/ft2. Therefore, as a
result of this rulemaking, laboratories
that wish to maintain or obtain NLLAP
recognition must be able to demonstrate
a quantitation limit equal to or less than
5 mg/ft2, and a method detection limit
no less than 0.5 mg/ft2 and no greater
than 2.5 mg/ft2.
In the proposed rule, EPA requested
comment on the achievability of lower
standards, including the ability of
laboratories to accurately test to lower
levels, in part to gain information on
how the rule would affect the status of
NLLAP-recognized laboratories. One
commenter claimed that EPA found that
the proposed DLHS are ‘‘detectable
among the labs used by’’ the HUD
grantees that are already subject to the
lower levels. Another commenter
asserted that ‘‘100% of the labs that
conduct lead tests are already equipped
to test lead dust with lower standards
than [are] currently being used.’’ EPA
agrees that the final DLHS are
achievable by HUD LHC grantees but
disagrees with the commenter’s
assertion that ‘‘100% of the labs that
conduct lead tests are already equipped
to test’’ for dust-lead at lower dust-lead
levels than the previous DLHS. As
mentioned in the proposed rule, HUD’s
policy guidance revision has already
required its OLHCHH’s LHC grantees to
use clearance levels of 10 mg/ft2 for
floors and 100 mg/ft2 for window sills
when conducting LHC activities (Ref.
51). Therefore, 100% of the laboratories
used by these grantees were using
laboratories with a reporting limit equal
to or less than 5 mg/ft2. Although this
means that ‘‘there is no technological
barrier to reducing the current standard
to the’’ revised DLHS, and the
laboratories used by the grantees are
able to do so (Ref. 5), it does not mean
that all of the NLLAP-recognized
laboratories are already able to meet the
lower LQSR limits associated with the
revised DLHS. Based on EPA’s
additional research, the agency believes
a little less than half of NLLAPrecognized laboratories are already able
to meet the lower LQSR limits
associated with the revised DLHS. In
addition, the other laboratories that
wish to maintain or obtain NLLAP
recognition will need to take actions to
meet the lower LQSR limits as a result
of this rulemaking (Ref. 14). EPA also
notes that if the DLHS were revised to
levels lower than this final rule, the
Agency is not confident based on
available data that the laboratories used
by the HUD grantees could meet the
lower LQSR limits.
There are a number of approaches by
which laboratories can meet the lower
LQSR limits. These approaches, in order
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of increasing burden for doing so
(including financial, time, and
personnel resources), are: Instruct their
customers to increase the wipe area;
modify sample preparation and revise
accreditation; or acquire new
instrumentation, modify sample
preparation, and revise accreditation.
Through EPA’s research on laboratories’
capability and capacity, EPA believes
that most if not all of the laboratories
that will need to take actions to meet the
lower LQSR limits will be able to do so
by instructing customers to increase the
wipe area, modifying the sample
preparation and revising accreditation,
or executing some combination of those
approaches with a revised DLHS at 10
mg/ft2 for floors and 100 mg/ft2 for
window sills (Ref. 14).
However, if EPA were to revise the
DLHS to levels lower than the levels in
this final rule, the viability of those less
burdensome approaches diminishes
sharply. With DLHS levels suggested by
commenters at 5 mg/ft2 for floors, EPA
estimates that a little over 40% of the
NLLAP-recognized laboratories would
either have to acquire new
instrumentation, modify sample
preparation, and revise accreditation, or
discontinue dust wipe analysis for lead
from their portfolio (Ref. 14). As further
explained in the following paragraphs,
EPA is concerned that laboratories that
are faced with the decision of whether
to meet lower LQSR limits may end up
discontinuing dust wipe analysis for
lead from their business models. This
diminished capacity for laboratories that
perform dust wipe analysis could in
turn be problematic for the regulated
community that conducts the sampling,
either in the form of increased cost of
analysis per sample, increased waiting
periods that make testing for dust-lead
hazards untenable, or a combination of
both. As the number of NLLAPrecognized labs decrease, this could
inadvertently put more children at risk
of prolonged lead exposure.
Increasing the wipe area is a less
burdensome, acceptable way that many
laboratories can meet the lower LQSR
limits associated with revisions to the
DLHS in this final rule of 10 mg/ft2 for
floors and 100 mg/ft2 for window sills.
Dust wipes are typically used to sample
a floor area of 1 ft2 (Ref. 52). Increasing
the wipe area will increase the amount
of lead collected, making it more likely
that the dust wipe sample will be
measurable above the new quantitation
limit without incurring additional
expense. Some laboratories have
indicated that they are able to test such
samples by instructing their customers
to wipe an area of 2 ft2 (Ref. 14). In
addition, several commenters relayed
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that samples have been taken using a 2
ft2 wipe area, and some laboratories
have indicated that this is how they are
meeting the HUD grant policy
requirements. The commenters declare
that a laboratory using less sensitive
instrumentation will have difficulty
meeting the lower requirements
associated with the revised DLHS
without the expansion of the wipe area.
Commenters also note there have not
been any problems reported by HUD
grantees concerning the increased wipe
area. Additionally, using a 2 ft2 wipe
area satisfies EPA’s LQSR limits. A
laboratory that modifies its sample
preparation or instrumentation for dust
wipe analysis would have to incur the
additional burden of modifying or
acquiring a new accreditation (Ref. 36),
but an increase in the wipe area does
not necessarily alter the sample
preparation or instrumentation.
Therefore, a laboratory that only
requires increased wipe areas may not
incur that additional burden. EPA
agrees with the commenters that
expanding the wipe area to 2 ft2 can be
an acceptable way for laboratories to
meet the lower requirements associated
with revisions to the DLHS in this final
rule.
There are several potential issues,
however, with expanding the sampling
area to 4 ft2 (Refs. 35 and 44). First,
although one laboratory EPA contacted
felt that it would be able to use its
currently less sensitive instrumentation
by instructing its customers to wipe a 4
ft2 area (Ref. 45), there was no
consensus among the laboratories with
whom EPA spoke as to whether it is
practical to increase the sampling area
to 4 ft2 in order to demonstrate
compliance with the LQSR if the DLHS
for floors was decreased to 5 mg/ft2 (Ref.
14). The larger wipe area could interfere
with the effectiveness of the sampling
method and cause problems with
preparation procedures and laboratory
instrumentation (Ref. 14). Therefore,
EPA does not believe that increasing the
wipe area to 4 ft2 would be a good
approach for laboratories faced with the
decision of how to meet the lower LQSR
limits with less sensitive
instrumentation, for a DLHS level lower
than 10 mg/ft2 for floors.
In addition, in some cases, window
sills do not have enough surface area to
allow for a sampling area that is large
enough to collect a sufficient amount of
dust-lead to meet all laboratories’
quantitation limits with their existing
analytical equipment.
Thus, EPA believes that setting the
DLHS at 10 mg/ft2 for floors and 100 mg/
ft2 for window sills is the best way to
maintain the current number of NLLAP-
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recognized laboratories by ensuring the
requirements can be implemented,
which in turn helps to maximize the
potential of this rule for continued risk
reduction.
With DLHS at 10 mg/ft2 for floors,
laboratories that are not able to meet the
LQSR limits by simply increasing the
wipe area, due to their own variable
processes and equipment, should be
able to do so by modifying the sample
preparation and revising their
accreditation to meet new testing limits.
There are several potential changes
laboratories can make to modify their
sample preparation that might allow a
laboratory to lower its quantitation limit
and method detection limit while using
the same analytical instrumentation. To
analyze dust wipe samples, laboratories
take the dust wipe, heat it in a solution,
and then analyze that solution for lead.
Hence, increasing the concentration of
lead in the digestate will facilitate
achieving measurements above the
quantitation limit without acquiring
new instrumentation. This can be
accomplished by reducing the final
volume by using a higher acid
concentration or evaporating the
digestate and thereby the final
concentration of lead for analysis.
Additionally, laboratories may be able
to use different equipment for heating
the solution that would allow use of a
lower volume of the digestate.
Laboratories that institute these
modifications would not need to start
from scratch with an entirely new
accreditation, but would have to modify
their existing accreditation to maintain
NLLAP recognition. However, these
modifications to sample preparation
have their limits. Several of the
laboratories that EPA talked to indicated
that these modifications would become
less viable if the DLHS were to decrease
below the levels in this final rule.
If the DLHS were set to levels lower
than 10 mg/ft2 for floors and 100 mg/ft2
for window sills, EPA believes that an
increasing number of the laboratories
that need to take actions to meet the
lower LQSR limits will have to use a
different type of analytical instrument
that is more sensitive, especially if the
DLHS were set to 5 mg/ft2 for floors and
40 mg/ft2 for window sills, as some
commenters requested. The majority of
the laboratories that would have to use
a different type of analytical instrument
would have to purchase new
instrumentation and revise their
accreditation. This accreditation
revision would likely have to include an
on-site inspection from an accreditation
body (Ref. 36). One commenter
mentioned that if new instrumentation
were required, such an upgrade could
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32641
cost between $80,000–$250,000, ‘‘not
including many consumable materials
and retrofitting the laboratory for the
equipment.’’ EPA agrees with the
commenter that the expense of new
instrumentation can be significant, and
notes that from its own research, the
time required to purchase the new
equipment, have it installed, run
validation studies, optimize the
methods and train personnel on its use,
and then to revise the accreditation with
an on-site inspection can be quite
disruptive to a laboratory’s operations.
This is especially true for smaller
laboratories with more limited
resources. As more laboratories
conclude that they must acquire new
instrumentation and revise their
accreditation with an on-site inspection,
the likelihood of more laboratories
discontinuing dust wipe analysis from
their portfolios increases.
After the promulgation of this final
rule lowering the DLHS, laboratories
that need to take actions to meet the
lower LQSR limits will have to take
time to review their situation, determine
the changes they need to make, decide
whether they want to continue in the
NLLAP program, and select among the
approaches previously described. For
DLHS lower than 10 mg/ft2 for floors, the
number of laboratories that would need
to acquire new instrumentation, modify
sample preparation, and revise their
accreditation with an on-site inspection
increases, which would take the most
time and resources to accomplish.
Laboratories that are faced with the
decision to either take these actions or
discontinue dust wipe analysis for lead
from their portfolios, are much more
likely to discontinue the analysis from
their portfolios if they cannot simply
increase the wipe area or modify their
sample preparation. Based on EPA’s
research on laboratories’ capabilities
and capacity, EPA believes more
laboratories may discontinue dust wipe
analysis for lead from their portfolios if
the DLHS were set lower than in this
final rule. For these reasons, in addition
to those discussed earlier in section
III.A.(2), EPA believes it is within its
discretion to set the DLHS at 10 mg/ft2
for floors and 100 mg/ft2 for window
sills in consideration of the potential for
risk reduction, including whether such
actions are achievable in relation to
their application in lead risk reduction
programs.
3. Effect of this change on EPA and
HUD Programs. a. EPA Risk
Assessments. As stated earlier in this
preamble, EPA’s risk assessment work
practice standards provide the basis for
risk assessors to determine whether LBP
hazards are present in target housing
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and COFs. As part of a risk assessment,
dust samples are taken from floors and
window sills to determine if dust-lead
levels exceed the DLHS. Results of the
sampling, among other things, are
documented in a risk assessment report
which is required under the LBP
Activities Rule (Ref. 21). In addition to
the sampling results, the report must
describe the location and severity of any
dust-lead hazards found and describe
interim controls or abatement measures
needed to address the hazards. Under
the LBP Activities Rule, risk assessors
will compare dust sampling results for
floors and window sills to the new,
lower DLHS from this rule. Sampling
results above the new hazard standard
will indicate that a dust-lead hazard is
present on the surfaces tested. EPA
expects that this will result in more
hazards being identified in a portion of
target housing and COFs that undergo
risk assessments. The final rule does not
change any other risk assessment
requirements.
b. EPA-HUD Disclosure Rule. Under
the Disclosure Rule (Ref. 6), prospective
sellers and lessors of target housing
must provide purchasers and renters
with a federally approved lead hazard
information pamphlet and disclose
known LBP and/or LBP hazards. The
information disclosure activities are
required before a purchaser or renter is
obligated under a contract to purchase
or lease target housing. Records or
reports pertaining to LBP or LBP
hazards must be disclosed, including
results from dust sampling regardless of
whether the level of dust-lead is below
the hazard standard. For this reason, the
lower dust-lead hazard standard will
not result in more information being
disclosed because property owners
would already be disclosing results that
show dust-lead below the original DLHS
of 40 mg/ft2 on floors or below 250 mg/
ft2 on window sills. However, a lower
dust-lead hazard standard may prompt
a different response on the lead
disclosure form, i.e., that a lead-based
paint hazard is present rather than not,
which will occur when a dust-lead level
is below the original standard but at or
above the standard in this final rule.
c. Renovation, Repair and Painting
(RRP) Rule. To avoid confusion about
the applicability of this final rule, EPA
notes that revising the DLHS will not
trigger new requirements under the
existing RRP Rule. The existing RRP
work practices are required where LBP
is present (or assumed to be present),
and are not predicated on dust-lead
loadings exceeding the hazard
standards. The existing RRP regulations
do not require dust sampling prior to or
at the conclusion of a renovation and,
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therefore, will not be directly affected
by this change to the DLHS.
d. HUD Requirements for Federallyassisted or Federally-owned housing.
Under sections 1012 and 1013 of Title
X, HUD established LBP hazard
notification, evaluation, and reduction
requirements for certain pre-1978 HUDassisted and federally-owned target
housing, known as the Lead Safe
Housing Rule (LSHR). See 24 CFR part
35, subparts B through R. The programs
covered by these requirements range
from supportive housing services to
foreclosed HUD-insured single-family
insured housing to public housing. For
programs where hazard evaluation is
required, the DLHS provide criteria to
risk assessors for identifying LBP
hazards in residences covered by these
programs. For programs that require
abatement of LBP hazards, the DLHS are
used to identify residences that contain
dust-lead hazards as part of determining
where abatement will be necessary.
e. HUD Guidelines. The HUD
Guidelines for the Evaluation and
Control of Lead-Based Paint Hazards in
Housing were developed in 1995 under
section 1017 of Title X. They provide
detailed, comprehensive, technical
information on how to identify LBP
hazards in residential housing and
COFs, and how to control such hazards
safely and efficiently. The Guidelines
were revised in 2012 to incorporate new
information, technological advances,
and new federal regulations, including
EPA’s LBP hazard standards. Based on
EPA’s changes in this final rule, HUD
plans to revise Chapter 5 of the
Guidelines on risk assessment and
reevaluation and Chapter 15 on
clearance based on those changes.
f. LSHR Clearance Requirements.
While this final rule does not change the
clearance levels under EPA’s
regulations, it will have the effect of
changing the clearance levels that apply
to hazard reduction activities under
HUD’s LSHR. The LSHR requires certain
hazard reduction activities to be
performed in certain federally-owned
and assisted target housing including
abatements, interim controls, paint
stabilization, and ongoing LBP
maintenance. Hazard reduction
activities are required in this housing
when LBP hazards are identified or
when maintenance or rehabilitation
activities disturb paint known or
presumed to be LBP. The LSHR’s
clearance regulations, 24 CFR 35.1340,
specify requirements for clearance of
these projects (when they disturb more
than de minimis amounts of known or
presumed lead-based painted surfaces,
as defined in 24 CFR 35.1350(d)),
including a visual assessment, dust
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sampling, submission of samples for
analysis for lead in dust, interpretation
of sampling results, and preparation of
a report. Clearance testing of abatements
and non-abatements is required by 24
CFR 35.1340(a) and (b), respectively.
The LSHR’s clearance regulations
cross-reference regulatory provisions to
establish clearance levels for abatements
that are different than those for nonabatement activities. The LSHR
clearance regulations for both
abatements and non-abatement
activities, at 24 CFR 35.1340(d), crossreference the standards, at 24 CFR
35.1320(b), to be used by risk assessors
for conducting clearance; in turn, the
standards at 24 CFR 35.1320(b) crossreference EPA’s DLHS at 40 CFR
745.227(h). In addition, the LSHR
clearance regulations for abatements, at
24 CFR 35.1340(a), which set forth that
clearance must be performed in
accordance with EPA regulations, crossreference EPA’s clearance standards for
abatements at 40 CFR 745.227(e).
Because the EPA’s DLHS and dust-lead
clearance standards for abatements were
the same, cross-referencing different
EPA regulatory provisions, at 40 CFR
745.227(e) and (h), had no effect on
hazard reduction activities under the
LSHR.
The LSHR clearance regulations for
non-abatement activities, at 24 CFR
35.1340(b) do not cross-reference EPA’s
clearance standards at 40 CFR
745.227(e). Only EPA’s DLHS at 40 CFR
745.227(h) are referenced at 24 CFR
1340(d) as the clearance standards for
non-abatement activities, because EPA
does not have its own clearance
standards for them. Accordingly, as
explained in the proposed rule, nonabatement activities under the LSHR
must be cleared using the EPA’s DLHS
when this final rule becomes effective.
EPA’s LBP activities regulations on
work practice requirements, at 40 CFR
745.65(d), specify that clearance
requirements applicable to LBP hazard
evaluation and hazard reduction
activities are found in both the LSHR, at
24 CFR part 35, subpart R, and EPA
regulations at 40 CFR part 745, subpart
L. For abatements covered by both
agencies’ regulations, the LSHR
regulations, at 24 CFR 35.145 and
35.1340(a), require clearance levels
following abatement of LBP or LBP
hazards to be at least as protective as
EPA’s clearance levels for abatements at
40 CFR 745.227(e).
This final rule revises the DLHS from
40 mg/ft2 and 250 mg/ft2 to 10 mg/ft2 and
100 mg/ft2 on floors and window sills,
respectively. As a result of this final
action, EPA’s DLHS will be lower than
EPA’s clearance standards for
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abatements, and according to HUD,
abatements under HUD’s LSHR will be
cleared using the EPA’s DLHS.
g. Effects of a Revision on Previous
LBP-related Activities. Since the DLHS
do not compel specific actions,
revisions to the DLHS would not in and
of themselves retroactively compel
actions. Inspection reports and risk
assessments describe conditions at a
specific time. A report that indicates no
presence of LBP and/or a LBP hazard
should not imply the absence of those
conditions in perpetuity. In addition,
this rulemaking by itself does not
impose retroactive requirements to
regulated entities that have previously
complied with the disclosure rule. A
seller or lessor must properly disclose
any available records or reports
pertaining to LBP, LBP hazards and/or
any lead hazard evaluative reports
‘‘before the purchaser or lessee is
obligated under any contract to
purchase or lease target housing that is
not otherwise an exempt transaction
pursuant to § 745.101’’ (40 CFR
745.107). The seller or lessor is not
required to disclose reports or records
that may be created in the future, after
the close of that transaction, in
perpetuity. Additionally, any LBP-free
certification that was issued by a
certified inspector, based on the
previous DLHS, and was issued before
the effective date of this rulemaking, is
still valid going forward and may
continue to be used for exemption to the
disclosure rule. However, the DLHS are
incorporated into requirements
mandated by state, federal, tribal, and
other programs that may require actions
based on the revised DLHS. Those other
authorities may want to consider
guidance or other communications with
their regulated communities, so those
entities understand how to comply with
the various programs that reference the
DLHS. A more comprehensive version
of EPA’s response on these issues can be
found in section 2.c. of the response to
comments document. (Ref. 30).
B. The Definition of Lead-Based Paint
As noted in the preamble, EPA has
neither opined nor concluded that the
definition of LBP may not be
sufficiently protective. In response to
the administrative petition (Ref. 28) and
throughout the litigation, EPA
maintained that it necessarily would
first consider whether revision to the
definition of LBP was appropriate. In
the proposed rule, EPA requested
comment on making no change to the
definition of LBP.
The definition of LBP is incorporated
throughout EPA’s LBP regulations, and
application of this definition is central
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to how EPA’s LBP program functions.
EPA believes that accounting for
feasibility and health effects would be
appropriate when considering a
revision. Given the current, significant
data gaps presented below and the new
approaches that would need to be
devised to address them, EPA continues
to lack sufficient information to
conclude that the current definition
requires revision or to support any
specific proposed change to the
definition of LBP. Some commenters in
support of changing the definition of
LBP discussed paint itself as a hazard,
advocating for analysis separate and
distinct from the causal relationship
between LBP and dust-lead hazards.
One commenter declared that, given
examples of an independent paint-lead
hazard, the current definition is ‘‘clearly
inadequate.’’ EPA reviewed these
comments and has expanded the
discussion of data gaps elsewhere in the
preamble to include direct ingestion of
paint. EPA did not receive any data
during the public comment period to
further inform whether a revision to the
current definition of LBP is warranted
or even possible at this time.
Evaluating whether revising the
definition of LBP is appropriate requires
analyzing levels of lead in paint that are
lower than what was examined
previously by EPA and other federal
agencies. In the proposal, EPA requested
any new available data or analyses of
the relationship among levels of lead in
paint, dust and risk of adverse health
effects. Although some commenters
supported updating the definition of
LBP and/or said that the current level is
inadequate, EPA did not receive data or
analyses that would further inform
whether a revision to the definition is
warranted at this time. More
information is needed to establish a
statistically valid causal relationship
between concentrations of lead in paint
(lower than the current definition) and
dust-lead loadings which 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 technology would
be affected under a possible revision to
the definition.
1. Relationship among lead in paint,
environmental conditions, and
exposure. EPA would need to further
explore the availability and application
of statistical modeling approaches that
establish robust linkages between the
concentration of lead in paint below the
current definition and dust-lead on
floors before EPA could develop a
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technically supportable proposal to
revise the definition of LBP based on
this route of exposure. To that end, EPA
is coordinating with HUD to evaluate
available data and approaches. Efforts
suggest that most available empirical
data and modeling approaches are only
applicable at or above the current LBP
definition (0.5% and 1 mg/cm2). The
highest dust-lead loadings from LBP are
expected to be a result of paint removal
activities during renovation. During
renovation, LBP may be disturbed and
abraded, leading to elevated dust-lead
loading available for incidental
ingestion. EPA developed a model to
estimate lead-based dust loadings from
renovation activities in various
renovation scenarios in 2014 and a
similar model was developed in 2011 by
Cox et al. However, the underlying data
that supported EPA’s 2014 model for
LBP was EPA’s 2007 dust study, which
included concentrations of lead in paint
ranging from 0.8% to 13% by weight.
The data that supported Cox et al. 2011
ranged from 0.7 to 13.2 mg/cm2
(converted to approximately 0.6% to
31% by weight) of lead in paint (Refs.
53; 54; and 55). Given that the range of
concentrations that support these
models are well above the petitioners’
requested concentration of lead in paint,
there would be significant uncertainty
associated with using these models to
make predictions regarding lead in paint
at concentrations an order of magnitude
below the current definition.
In an attempt to address this
uncertainty and build a modeling
approach, EPA conducted a literature
search for studies that co-report lead
concentrations in paint and dust in
order to identify available data (Ref. 53).
Among other things, EPA looked to the
literature to establish statistically valid
associations between low
concentrations of LBP and lead in dust,
but was unable to find sufficient
information to estimate concentrations
of lead in household dust from paint
concentrations below 0.8% by weight.
Thus, EPA still needs to consider
generation of new data, since, as
discussed elsewhere in this document,
EPA believes there is significant
uncertainty associated with estimating
dust-lead loadings for levels of lead in
paint up to an order of magnitude lower
than levels in the current definition
using the existing models (Ref. 53), Cox
et al. (Ref. 54). Such data is needed for
EPA to develop an approach to estimate
dust-lead from lower levels of lead in
paint so that EPA could estimate
incremental blood lead changes and
associated health effects changes as
described in the existing dust-lead
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approach. This may involve conducting
laboratory or field studies to
characterize the relationship between
LBP and dust-lead at lower levels of
lead in paint (<0.5%) (Ref. 53).
2. Quantify exposure from direct paint
ingestion. EPA would need to
understand and develop an approach for
estimating the amount of direct paint
consumption and subsequent exposure
by children before EPA could develop a
technically supportable proposal to
revise the definition of LBP based on
ingestion of paint chips and direct
teething of painted surfaces. Past studies
have documented pica behavior as a risk
factor for exposure to lead from LBP,
however these studies have not
provided a quantitative estimate of paint
ingestion. Epidemiological studies
generally rely on caregiver observations
to classify whether a child has ever been
known to consume paint chips. As
described further in the Definition of
Lead-Based Paint Considerations (Ref.
53), past studies estimate that a fraction
of young children are known to have
directly ingested paint, and published
case studies of individual children
provide radiographic evidence of paint
chip ingestion. However, neither
provide quantitative estimates of the
amount of LBP ingested over time by
children, information which is needed
to quantify exposure.
3. Feasibility. In the proposal, EPA
requested any new available data on the
technical feasibility of a revised
definition of LBP. EPA lacks sufficient
information to support a change to the
definition of LBP with respect to
feasibility. Significant data gaps prevent
the Agency from evaluating and
subsequently determining that a change
to the existing definition is warranted.
EPA did not receive any comments with
substantive information about whether
portable field technologies utilized in
EPA’s LBP Activities and RRP programs,
as well as HUD’s LSHR, perform reliably
at significantly lower concentrations of
lead in paint.
Portable X-ray fluorescence (XRF)
LBP analyzers are the primary analytical
method for inspections and risk
assessments in housing because they
can be used to quickly, nondestructively and inexpensively
determine if LBP is present on many
surfaces. These measurements do not
require destructive sampling or paint
removal. Renovation firms may also hire
inspectors or risk assessors to conduct
XRF testing to identify the presence of
LBP. When using XRF technology, the
instrument exposes the substrate being
tested to electromagnetic radiation in
the form of X-rays or gamma radiation.
In response to radiation, the lead
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present in the substrate emits energy at
a fixed and characteristic level. The
emission is called ‘‘X-Ray
Fluorescence,’’ or XRF (Ref. 52).
XRF Performance Characteristic
Sheets (PCS) have been developed by
HUD and/or EPA for most commercially
available XRF analyzers (XRFs). In order
to comport with the HUD Guidelines for
the Evaluation and Control of LeadBased Paint Hazards in Housing, an XRF
instrument that is used for testing paint
in target housing or pre-1978 COFs must
have a HUD-issued XRF PCS. XRFs
must be used in accordance with the
manufacturer’s instructions and the
PCS. The PCS contains information
about XRF readings taken on specific
substrates, calibration check tolerances,
interpretation of XRF readings, and
other aspects of the model’s
performance. For every XRF analyzer
evaluated by EPA and/or HUD, the PCS
defines acceptable operating
specifications and procedures. The
ranges where XRF results are positive,
negative or inconclusive for LBP, the
calibration check tolerances, and other
important information needed to ensure
accurate results are also included in the
PCS. An inspector and risk assessor
must follow the XRF PCS for all LBP
activities, and only devices with a
posted PCS may be used for LBP
inspections and risk assessments (Ref.
52).
XRF analyzers and their
corresponding PCS sheets were
developed to be calibrated with the
current definition of LBP. Therefore,
these instruments would need to be reevaluated to determine the capabilities
of each instrument model available in
the market to meet a potentially revised
definition of LBP, and the
corresponding PCS would need to be
amended accordingly. If, as a result of
a revised definition of LBP, the use of
XRFs suddenly became unavailable, the
effectiveness of the LBP activities
programs would be severely harmed.
Since these instruments are the primary
analytical method for inspections and
risk assessments performed pursuant to
the LBP activities regulations, EPA
would need to understand how a
potential revision to the definition of
LBP would affect the ability of the
regulated community to use this
technology.
When conducting renovations,
contractors must determine whether or
not their project will involve LBP, and
thus fall under the scope of the RRP
regulations under 40 CFR part 745,
subpart E, or in certain jurisdictions,
authorized state and Indian tribal
programs under subpart Q (see Unit
III.C). Under the RRP rule, renovators
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have the flexibility to choose among
four strategies: Use (1) a lead test kit, (2)
an XRF instrument, (3) paint chip
sampling to indicate whether LBP is
present; or (4) assume that LBP is
present and follow all the work-practice
requirements. For those using lead test
kits, only test kits recognized by the
EPA can be used for this purpose. EPArecognized lead test kits used for the
RRP program were evaluated through
EPA’s Environmental Technology
Verification (ETV) Program or by the
National Institute of Standards and
Technology. ETV was a public-private
partnership between EPA and nonprofit
testing and evaluation organizations that
verified the performance of innovative
technologies. ETV evaluated the
reliability of the technology used for onsite testing of LBP at the regulated level,
under controlled conditions in a
laboratory. ETV ended operations in
early 2014. EPA would need to evaluate
lead test kits using ETV-equivalent
testing for a potential revision of the
definition of LBP. This would allow
EPA to evaluate the reliability of test
kits for testing LBP under controlled
conditions at levels lower than the
current LBP definition, so contractors
could continue to use this important
tool in compliance with the RRP
regulations.
The regulated community uses XRF
analyzers for inspections and risk
assessments and uses lead test kits to
determine the presence of LBP during
renovations. In consideration of any
potential revised definition of LBP, EPA
would need to fully understand the
repercussions of such a revision on
these portable field technologies in
order to ensure the technological
feasibility of any new revision. The
methods EPA would need to employ to
do so would involve complex processes
that include evaluating the potential
ability of XRF analyzers to detect LBP
at lower levels than the current
definition, the ability to recalibrate
performance characteristic sheets for
each available model of XRF analyzer,
and re-evaluating lead test kits under
controlled conditions in a laboratory.
EPA currently lacks sufficient
information to support such an
undertaking.
C. State Authorization
Pursuant to TSCA section 404, a
provision was made for interested
states, territories and tribes to apply for
and receive authorization to administer
their own LBP activities programs, as
long as their programs are at least as
protective of human health and the
environment as the Agency’s program
and provides adequate enforcement.
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The regulations applicable to state,
territorial and tribal programs are
codified at 40 CFR part 745, subpart Q.
As part of the authorization process,
states, territories and tribes must
demonstrate to EPA that they meet the
requirements of the LBP Activities Rule.
Over time, the Agency may make
changes to these requirements. To
address the changes in this final rule
and future changes to the LBP Activities
Rule, the Agency is requiring states,
territories and tribes to demonstrate that
they meet any new requirements
imposed by this rulemaking in order to
maintain or obtain authorization. Under
this requirement, authorized states,
territories and tribes have up to two
years to demonstrate that their programs
include any new requirements that EPA
promulgates. A state, territory or tribe
must indicate that it meets the
requirements of the LBP Activities
program in its application for
authorization or, if already authorized,
in a report it must submit in accordance
with 40 CFR 745.324(h) no later than
two years after the effective date of the
new requirements. If an application for
authorization has been submitted but
not yet approved, the state, territory or
tribe must demonstrate that it meets the
new requirements by either amending
its application, or in a report it submits
under 40 CFR 745.324(h) no later than
two years after the effective date of the
new requirements. The Agency believes
that this requirement allows sufficient
time for states, territories and tribes to
demonstrate that their programs contain
requirements at least as protective as
any new requirements that EPA may
promulgate.
D. Effective Date
EPA has considered the impacts of the
revised DLHS on NLLAP-recognized
laboratories. This rule will become
effective on January 6, 2020 in order to
provide a reasonable amount of time for
NLLAP-recognized laboratories to take
actions to meet the lower LQSR limits
so they can continue providing dust
wipe testing services to the regulated
community at the time the rule becomes
effective.
In order to obtain a better
understanding of laboratories’ capability
and capacity for dust wipe analysis,
EPA conducted teleconferences with
two accrediting organizations (Refs. 34;
35; and 36), five federally funded
laboratories (Refs. 37; 38; 39; 40; and
41), and nine state or privately funded
laboratories (Refs. 42; 43; 44; 45; 46; 47;
48; 49; and 50). Based on these
conversations, EPA estimated that over
half of accredited laboratories would
have to take actions to meet the lower
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LQSR limits. They can accomplish this
by asking their customers to increase the
wipe area sampled and/or revising their
operating procedures, validating the
changes, and revising their accreditation
accordingly. Such actions can take
months to complete. EPA therefore
believes that the effective date provides
needed flexibility for laboratories while
ensuring that the revised DLHS become
effective in a timely manner.
IV. References
The following is a listing of the
documents that are specifically
referenced in this document. The docket
includes these documents and other
information considered by EPA,
including documents that are referenced
within the documents that are included
in the docket, even if the referenced
document is not physically located in
the docket. For assistance in locating
these other documents, please consult
the technical person listed under FOR
FURTHER INFORMATION CONTACT.
1. Public Law 102–550, Title X—Housing and
Community Development Act, enacted
October 28, 1992 (also known as the
Residential Lead-Based Paint Hazard
Reduction Act of 1992 or ‘‘Title X’’) (42
U.S.C. 4851 et seq.).
2. U.S. Court of Appeals for the Ninth
Circuit. A Community Voice v. EPA, No.
16–72816, Opinion. December 27, 2017.
3. U.S. Court of Appeals for the Ninth
Circuit. A Community Voice v. EPA, No.
16–72816, Order. March 26, 2018.
4. EPA. Lead; Identification of Dangerous
Levels of Lead; Final Rule. Federal
Register (66 FR 1206, January 5, 2001)
(FRL–6763–5).
5. EPA. Review of the Dust-Lead Hazard
Standards and the Definition of LeadBased Paint; Proposed Rule. Federal
Register (83 FR 30889, July 2, 2018)
(FRL–9976–04).
6. HUD, EPA. Lead; Requirements for
Disclosure of Known Lead-Based Paint
and/or Lead-Based Paint Hazards in
Housing; Final Rule. Federal Register
(61 FR 9064, March 6, 1996) (FRL–5347–
9).
7. President’s Task Force on Environmental
Health Risks and Safety Risks to
Children. Federal Action Plan to Reduce
Childhood Lead Exposures and
Associated Health Impacts. December
2018. https://www.epa.gov/lead/federalaction-plan-reduce-childhood-leadexposure.
8. CDC. CDC Response to Advisory
Committee on Childhood Lead Poisoning
Prevention Recommendations in ‘‘Low
Level Lead Exposure Harms Children: A
Renewed Call of Primary Prevention.’’
June 7, 2012. https://www.cdc.gov/nceh/
lead/acclpp/cdc_response_lead_
exposure_recs.pdf.
9. CDC. Blood Lead Levels in Children Aged
1–5 Years—United States, 1999–2010.
CDC Morbidity and Mortality Weekly
Report, Vol. 62 No. 13, April 5, 2013.
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https://www.cdc.gov/mmwr/pdf/wk/
mm6213.pdf.
10. EPA. Integrated Science Assessment (ISA)
for Lead (Final Report, Jul 2013). U.S.
EPA, Washington, DC, EPA/600/R–10/
075F, 2013. https://cfpub.epa.gov/ncea/
isa/recordisplay.cfm?deid=255721.
11. HHS, National Toxicology Program. NTP
Monograph on Health Effects of LowLevel Lead. National Institute of
Environmental Health Sciences,
Research Triangle Park, NC. NIH Pub.
No. 12–5996. ISSN 2330–1279. June 13,
2012. https://ntp.niehs.nih.gov/ntp/ohat/
lead/final/monographhealtheffects
lowlevellead_newissn_508.pdf.
12. Children’s Health Protection Advisory
Committee (CHPAC). Letter to Lisa P.
Jackson RE: Childhood Lead Poisoning
Prevention. March 29, 2012. https://
www.epa.gov/sites/production/files/
2015-10/documents/chpac_lead_letter_
2012_03_29.pdf.
13. CHPAC. Letter to Scott Pruitt RE: Highest
Priorities for Childhood Lead Exposure
Prevention. March 24, 2017. https://
www.epa.gov/sites/production/files/
2017-04/documents/2017.03.24_chpac_
lead_hazard_reduction_letter.pdf.
14. EPA, Office of Pollution Prevention and
Toxics. Economic Analysis of the Final
Rule to Revise the TSCA Dust-Lead
Hazard Standards. June 2019.
15. CDC. Lead Poisoning in Children
(February 2011). https://www.cdc.gov/
healthcommunication/toolstemplates/
entertainmented/tips/LeadPoisoning
Children.html.
16. Agency for Toxic Substances and Disease
Registry, Division of Toxicology and
Human Health Sciences. Lead—
ToxFAQsTM CAS # 7439–92–1, August
2007. https://www.atsdr.cdc.gov/toxfaqs/
tfacts13.pdf.
17. EPA. Exposure Factors Handbook
Chapter 5 (Update): Soil and Dust
Ingestion. U.S. EPA Office of Research
and Development, Washington, DC,
EPA/600/R–17/384F, 2017. https://
cfpub.epa.gov/ncea/risk/recordisplay.
cfm?deid=236252.
18. EPA, Office of Pollution Prevention and
Toxics. Technical Support Document for
Residential Dust-lead Hazard Standards
Rulemaking Approach taken to Estimate
Blood Lead Levels and Effects from
Exposures to Dust-lead. June 2019.
19. Zartarian, V., Xue, J., Tornero-Velez, R.,
& Brown, J. Children’s Lead Exposure: A
Multimedia Modeling Analysis to Guide
Public Health Decision-Making.
Environmental Health Perspectives,
125(9), 097009–097009. September 12,
2017. https://doi.org/10.1289/EHP1605.
20. President’s Task Force on Environmental
Health Risks and Safety Risks to
Children. Key Federal Programs to
Reduce Childhood Lead Exposures and
Eliminate Associated Health Impacts.
November 2016. https://
ptfceh.niehs.nih.gov/features/assets/
files/key_federal_programs_to_reduce_
childhood_lead_exposures_and_
eliminate_associated_health_
impactspresidents_508.pdf.
21. EPA. Lead; Requirements for Lead-Based
Paint Activities in Target Housing and
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Child-Occupied Facilities; Final Rule.
Federal Register (61 FR 45778, August
29, 1996) (FRL–5389–9).
22. EPA. Lead; Renovation, Repair, and
Painting Program; Final Rule. Federal
Register (73 FR 21692, April 22, 2008)
(FRL–8355–7).
23. EPA. Lead; Amendment to the Opt-Out
and Recordkeeping Provisions in the
Renovation, Repair, and Painting
Program; Final Rule. Federal Register
(75 FR 24802, May 6, 2010) (FRL–8823–
7).
24. EPA. Lead; Clearance and Clearance
Testing Requirements for the
Renovation, Repair, and Painting
Program; Final Rule. Federal Register
(76 FR 47918, August 5, 2011) (FRL–
8881–8).
25. HUD. Requirements for Notification,
Evaluation and Reduction of Lead-Based
Paint Hazards in Federally Owned
Residential Property and Housing
Receiving Federal Assistance; Response
to Elevated Blood Lead Levels; Final
Rule. Federal Register (82 FR 4151,
January 13, 2017) (FR–5816–F–02).
26. HUD, Office of Lead Hazard Control and
Healthy Homes. Lead Hazard Control
Clearance Survey. Final Report. October
2015. https://www.hud.gov/sites/
documents/CLEARANCESURVEY_
24OCT15.PDF.
27. Sierra Club et al. Letter to Lisa Jackson
RE: Citizen Petition to EPA Regarding
the Paint and Dust Lead Standards.
August 10, 2009. https://www.epa.gov/
sites/production/files/2015-10/
documents/epa_lead_standards_
petition_final.pdf.
28. EPA. Letter in response to citizen petition
under section 553(e) of the
Administrative Procedure Act (5 U.S.C.
553(e)). October 22, 2009.
29. EPA. News Releases from Headquarters:
Chemical Safety and Pollution
Prevention (OCSPP). EPA Proposes
Strengthening the Dust-Lead Hazard
Standards to Reduce Exposures to
Children. June 22, 2018. https://
www.epa.gov/newsreleases/epaproposes-strengthening-dust-leadhazard-standards-reduce-exposureschildren.
30. EPA. Review of The Dust-Lead Hazard
Standards and the Definition of LeadBased Paint. Response to Public
Comments. June 2019.
31. CDC, National Center for Health
Statistics. National Health and Nutrition
Examination Survey: Questionnaires,
Datasets, and Related Documentation.
https://wwwn.cdc.gov/nchs/nhanes/
Default.aspx. Accessed March 22, 2019.
32. Wilson, J., et al. Evaluation of HUDfunded lead hazard control treatments at
6 years post-intervention. 102
Environmental Research 237–248. June
5, 2006. https://
pdfs.semanticscholar.org/8742/
4e5649d22b93d9b1265
178e118716d5147fa.pdf.
33. EPA. EPA National Lead Laboratory
Accreditation Program. Laboratory
Quality System Requirements (LQSR),
Revision 3.0. November 5, 2007. https://
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www.epa.gov/lead/national-leadlaboratory-accreditation-programlaboratory-quality-system-requirementsrevision.
34. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and A2LA. September 21, 2018.
35. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and American Industrial Hygiene
Association. September 4, 2018.
36. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and American Industrial Hygiene
Association. September 26, 2018.
37. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and Lawrence Livermore National
Laboratory. October 11, 2018.
38. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and Navy & Marine Corp Public
Health Center. October 30, 2018.
39. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and Navy Environmental &
Preventative Medicine, Unit 2 CIHL.
October 31, 2018.
40. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and Norfolk Naval Shipyard,
Environmental Chemistry Laboratory.
October 25, 2018.
41. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and US Army Public Health Center,
Aberdeen Proving Ground. October 18,
2018.
42. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and ACT Environmental Services,
Inc. November 15, 2018.
43. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and Atlas Environmental
Laboratory. November 6, 2018.
44. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and Eastern Analytical Services,
Inc. November 6, 2018.
45. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and EMSL Analytical, Inc. October
24, 2018.
46. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and Fiberquant Analytical Services.
November 5, 2018.
47. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and Forensic Analytical
Laboratories, Inc. October 23, 2018.
48. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and QuanTEM Laboratories.
November 13, 2018.
49. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and R. J. Lee Group, Inc. October 24,
2018.
50. EPA, Office of Pollution Prevention and
Toxics. Summary of discussion between
EPA and University of Iowa Hygienic
Laboratory. November 1, 2018.
51. HUD, Office of Lead Hazard Control and
Healthy Homes. Revised Dust-Lead
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Action Levels for Risk Assessment and
Clearance. OLHCHH Policy Guidance
2017–01 Rev 1. February 16, 2017.
https://www.hud.gov/sites/documents/
LeadDustLevels_rev1.pdf.
52. HUD, Office of Lead Hazard Control and
Healthy Homes. Guidelines for the
Evaluation and Control of Lead-Based
Paint Hazards in Housing. Second
Edition, July 2012. https://www.hud.gov/
program_offices/healthy_homes/lbp/
hudguidelines.
53. EPA, Office of Pollution Prevention and
Toxics. Definition of Lead-Based Paint
Considerations. June 2019.
54. Cox et al. Improving the Confidence Level
in Lead Clearance Examination Results
through Modifications to Dust Sampling
Protocols. Journal of ASTM
International, Vol. 8, No. 8. 2011.
55. EPA, Office of Pollution Prevention and
Toxics. Revised Final Report on
Characterization of Dust Lead Levels
After Renovation, Repair, and Painting
Activities. November 13, 2007. https://
www.epa.gov/lead/revised-final-reportcharacterization-dust-lead-levels-afterrenovation-repair-and-painting.
V. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is an economically
significant regulatory action that was
submitted to the Office of Management
and Budget (OMB) for review under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011). Any changes made in
response to OMB recommendations
have been documented in the docket.
The Agency prepared an analysis of the
potential costs and benefits associated
with this action, which is available in
the docket (Ref. 14).
B. Executive Order 13771: Reducing
Regulations and Controlling Regulatory
Costs
This action is considered an
Executive Order 13771 regulatory action
(82 FR 9339, February 3, 2017). Details
on the estimated costs of this final rule
can be found in EPA’s analysis of the
potential costs and benefits associated
with this action.
C. Paperwork Reduction Act (PRA)
This action does not directly impose
an information collection burden under
the PRA, 44 U.S.C. 3501 et seq. Under
24 CFR part 35, subpart A, and 40 CFR
part 745, subpart F, sellers and lessors
must already provide purchasers or
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Federal Register / Vol. 84, No. 131 / Tuesday, July 9, 2019 / Rules and Regulations
lessees any available records or reports
‘‘pertaining to’’ LBP, LBP hazards and/
or any lead hazard evaluative reports
available to the seller or lessor.
Accordingly, a seller or lessor must
disclose any reports showing dust-lead
levels, regardless of the value. Thus, this
action would not result in additional
disclosures. Because there are no new
information collection requirements to
consider under the proposed rule, or
any changes to the existing
requirements that might impact existing
information collection request burden
estimates, additional OMB review and
approval under the PRA is not
necessary.
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D. Regulatory Flexibility Act (RFA)
I certify that this action will not have
a significant economic impact on a
substantial number of small entities
under the RFA, 5 U.S.C. 601 et seq. In
making this determination, the impact
of concern is any significant adverse
economic impact on small entities. The
small entities subject to the
requirements of this action are small
businesses that are landlords who may
incur costs for lead hazard reduction
measures in compliance with the HUD
Lead Safe Housing Rule (LSHR);
residential remodelers (who may incur
costs associated with additional
cleaning and sealing in houses
undergoing rehabilitation subject to the
HUD LSHR); and abatement firms (who
may also incur costs associated with
additional cleaning and sealing under
the LSHR). The Agency has determined
that approximately 15,000 small
businesses would be subject to this rule,
of which 96% have cost impacts less
than 1% of revenues, 4% have impacts
between 1% and 3% of revenues, and
less than 1% have impacts greater than
3% of revenues. Details of the analysis
of the potential costs and benefits
associated with this action are presented
in EPA’s Economic Analysis, which is
available in the docket (Ref. 14).
The rule sets health-based hazard
standards for dust lead loadings on
floors and window sills. The DLHS do
not require the owners of properties
covered by this final rule to evaluate
their properties for the presence of dustlead hazards, or to take action if dustlead hazards are identified. Although
these regulations do not compel specific
actions to address identified LBP
hazards, these standards are directly
incorporated by reference into certain
requirements mandated by HUD in
housing subject to the LSHR. Aside from
the HUD regulations, this rule does not
impose new federal requirements on
small entities.
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EPA’s Economic Analysis estimates
potential costs for activities in two types
of target housing—those subject to the
HUD LSHR and those where a child
with a blood lead level exceeding a
federal or state threshold lives. The
analysis presents low and high
scenarios for the number of housing
units where a child with a blood lead
level exceeding a federal or state
threshold lives. For the low scenario,
environmental investigations are
assumed to be conducted when a child’s
blood lead level exceeds the threshold
set by that child’s state. These
thresholds vary from 5 mg/dL to 20 mg/
dL, depending on the state. For the high
scenario, environmental investigations
are assumed to be conducted when a
child’s blood lead level exceeds the
CDC’s reference level of 5 mg/dL.
In order to estimate the broader
potential impacts of the rule, EPA
assumed that environmental
investigations triggered by a child with
a blood lead level exceeding a federal or
state threshold include dust wipe
testing of the child’s home and that a
clean-up occurs whenever the
investigation indicates that dust-lead
levels exceed a hazard standard. As
previously indicated, the rule does not
require these actions. Where dust-lead
levels are below the standards in the
2001 rule but above the standards in
this final rule, the potential clean-up
costs are also included in the economic
analysis. The low and high scenarios for
the number of housing units affect the
estimated number of small business that
might incur costs for cleaning and
additional dust wipe testing once the
hazard standards in this final rule are in
effect. Based on the two scenarios, a
total of 22,000 to 48,000 small
businesses are considered in the
analysis (this total includes those firms
mentioned above in the discussion of
the HUD LSHR). About 7,000 to 33,000
are lessors leasing housing where a
child with a blood lead level exceeding
a federal or state threshold resides.
When considering this broader set of
firms, EPA’s analysis indicates that
nearly 300 landlords that are small
businesses may have cost impacts over
3% under the low scenario, and almost
1,500 may have such impacts under the
high scenario. However, the high
scenario makes a series of assumptions
that are likely to overstate costs and
impacts. The high scenario assumes that
in all instances where a child’s blood
lead level is between the threshold set
by that child’s state and the CDC
reference value, the dust lead levels are
tested in the residence even when not
required; that in all cases where the
loadings are above the hazard standard
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32647
in a rental unit the landlord takes
action, and incurs costs, to reduce the
dust lead levels even when that is not
required. The analysis further assumes
that in all those cases the costs are borne
entirely by the landlord (as opposed to
being passed through or recouped in
whole or in part through increased rent).
As a result of this series of conservative
assumptions, the high scenario
functions as a bounding estimate. A
more realistic assessment of the
potential impacts is that they are
between the high and low scenarios. In
light of these considerations, even if the
broader set of firms were to be
considered, EPA would certify that this
action would not have a significant
economic impact on a substantial
number of small entities.
E. Unfunded Mandates Reform Act
(UMRA)
This action does not contain an
unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C.
1531–1538, and does not significantly or
uniquely affect small governments. The
total estimated annual cost of the
proposed rule is $32 million to $117
million per year (Ref. 14), which does
not exceed the inflation-adjusted
unfunded mandate threshold of $156
million.
F. Executive Order 13132: Federalism
This action does not have federalism
implications, as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999). It will not have substantial direct
effects on the states, on the relationship
between the national government and
the states, or on the distribution of
power and responsibilities among the
various levels of government. States that
have authorized LBP Activities
programs must demonstrate that they
have DLHS at least as protective as the
standards at 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 new DLHS they can
relinquish their authorization. In the
absence of a state authorization, EPA
will administer these requirements.
Thus, Executive Order 13132 does not
apply to this action.
G. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000). Tribes that have authorized LBP
Activities programs must demonstrate
that they have DLHS at least as
protective as the standards at 40 CFR
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Federal Register / Vol. 84, No. 131 / Tuesday, July 9, 2019 / Rules and Regulations
745.227. However, authorized tribes are
under no obligation to continue to
administer the LBP Activities program,
and if they do not wish to adopt new
DLHS they can relinquish their
authorization. In the absence of a Tribal
authorization, EPA will administer
these requirements. Thus, Executive
Order 13175 does not apply to this
action.
are higher than the nationwide average.
The revised hazard standards would
reduce exposure to lead for all residents
of affected housing. Therefore, EPA has
determined that the regulatory options
will not have disproportionately high
and adverse human health or
environmental effects on any
population, including any minority
population or low-income population.
H. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is subject to Executive
Order 13045 (62 FR 19885, April 23,
1997), because it is economically
significant as defined in Executive
Order 12866, and because the
environmental health or safety risk
addressed by this action may have a
disproportionate effect on children.
(Ref. 18)
The primary purpose of this rule is to
reduce exposure to dust-lead hazards in
target housing where children reside
and in target housing or COFs. EPA’s
analysis indicates that there will be
approximately 50,000 to 200,000
children per year affected by the rule
(Ref. 14).
L. Congressional Review Act (CRA)
I. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution or Use
This action is not a ‘‘significant
energy action’’ as defined in Executive
Order 13211 (66 FR 28355, May 22,
2001), because it is not likely to have a
significant adverse effect on the supply,
distribution or use of energy.
khammond on DSKBBV9HB2PROD with RULES
J. National Technology Transfer and
Advancement Act (NTTAA)
Since this rulemaking does not
involve technical standards, NTTAA
section 12(d) (15 U.S.C. 272 note) does
not apply to this action.
K. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
This action is not expected to have
disproportionately high and adverse
human health or environmental effects
on minority populations, low-income
populations and/or indigenous peoples,
as specified in Executive Order 12898
(59 FR 7629, February 16, 1994). The
documentation for this decision is
contained in the Economic Analysis,
which is available in the docket (Ref.
14). EPA’s Economic Analysis estimates
that the average baseline blood lead
levels of children who are affected by
the rule (particularly children in
minority and low-income households)
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This action is subject to the CRA, 5
U.S.C. 801 et seq., and the EPA will
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. This action
is a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 745
Environmental protection, Hazardous
substances, Lead poisoning, Reporting
and recordkeeping requirements.
Dated: June 21, 2019.
Andrew R. Wheeler,
Administrator.
Therefore, 40 CFR chapter I,
subchapter R, is amended as follows:
PART 745—[AMENDED]
1. The authority citation for part 745
continues to read as follows:
■
Authority: 15 U.S.C. 2605, 2607, 2681–
2692 and 42 U.S.C. 4852d.
2. In § 745.65, paragraph (b) is revised
to read as follows:
■
§ 745.65
Lead-based paint hazards.
*
*
*
*
*
(b) Dust-lead hazard. A dust-lead
hazard is surface dust in a residential
dwelling or child-occupied facility that
contains a mass-per-area concentration
of lead equal to or exceeding 10 mg/ft2
on floors or 100 mg/ft2 on interior
window sills based on wipe samples.
*
*
*
*
*
■ 3. In § 745.227, paragraph (h)(3)(i) is
revised to read as follows:
4. In § 745.325, paragraph (e) is
revised to read as follows:
■
§ 745.325 Lead-based paint activities:
State and Tribal program requirements.
*
*
*
*
*
(e) Revisions to lead-based paint
activities program requirements. When
EPA publishes in the Federal Register
revisions to the lead-based paint
activities program requirements
contained in subpart L of this part:
(1) A State or Tribe with a lead-based
paint activities program approved before
the effective date of the revisions to the
lead-based paint activities program
requirements in subpart L of this part
must demonstrate that it meets the
requirements of this section in a report
that it submits pursuant to § 745.324(h)
but no later than two years after the
effective date of the revisions.
(2) A State or Tribe with an
application for approval of a lead-based
paint activities program submitted but
not approved before the effective date of
the revisions to the lead-based paint
activities program requirements in
subpart L of this part must demonstrate
that it meets the requirements of this
section either by amending its
application or in a report that it submits
pursuant to § 745.324(h) but no later
than two years after the effective date of
the revisions.
(3) A State or Tribe submitting its
application for approval of a lead-based
paint activities program on or after the
effective date of the revisions must
demonstrate in its application that it
meets the requirements of the new leadbased paint activities program
requirements in subpart L of this part.
[FR Doc. 2019–14024 Filed 7–8–19; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
§ 745.227 Work practice standards for
conducting lead-based paint activities:
target housing and child-occupied facilities.
[Docket No. 120815345–3525–02]
*
Snapper-Grouper Fishery of the South
Atlantic; 2019 Commercial
Accountability Measure and Closure
for the Other Jacks Complex
*
*
*
*
(h) * * *
(3) * * *
(i) In a residential dwelling on floors
and interior window sills when the
weighted arithmetic mean lead loading
for all single surface or composite
samples of floors and interior window
sills are equal to or greater than 10 mg/
ft2 for floors and 100 mg/ft2 for interior
window sills, respectively;
*
*
*
*
*
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RIN 0648–XS002
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
NMFS implements an
accountability measure (AM) for the
SUMMARY:
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Agencies
[Federal Register Volume 84, Number 131 (Tuesday, July 9, 2019)]
[Rules and Regulations]
[Pages 32632-32648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14024]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 745
[EPA-HQ-OPPT-2018-0166; FRL-9995-49]
RIN 2070-AJ82
Review of the Dust-Lead Hazard Standards and the Definition of
Lead-Based Paint
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: Addressing childhood lead exposure is a priority for EPA. As
part of EPA's efforts to reduce childhood lead exposure, EPA evaluated
the current dust-lead hazard standards (DLHS) and the definition of
lead-based paint (LBP). Based on this evaluation, this final rule
revises the DLHS from 40 [micro]g/ft\2\ and 250 [micro]g/ft\2\ to 10
[micro]g/ft\2\ and 100 [micro]g/ft\2\ on floors and window sills,
respectively. EPA is also finalizing its proposal to make no change to
the definition of LBP because insufficient information exists to
support such a change at this time.
DATES: This final rule is effective January 6, 2020.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2018-0166, is available at
https://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
John Yowell, National Program Chemicals Division, Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 202-
564-1213; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially 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 in
accordance with 40 CFR 745.226, or if you conduct rehabilitations in
accordance with 24 CFR part 35. You may also be affected by this action
if you operate a laboratory that is recognized by EPA's National Lead
Laboratory Accreditation Program (NLLAP) in accordance with 40 CFR
745.90, 745.223, 745.227, 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. For further information regarding the
authorization status of states, territories, and tribes, contact the
National Lead Information Center at 1-800-424-LEAD (5323). 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.
Potentially affected entities may include:
Building construction (NAICS code 236), e.g., single-
family housing construction, multi-family housing construction,
residential remodelers.
[[Page 32633]]
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.
Real estate (NAICS code 531), e.g., lessors of residential
buildings and dwellings, residential property managers.
Child day care services (NAICS code 624410).
Elementary and secondary schools (NAICS code 611110),
e.g., elementary schools with kindergarten classrooms.
Other technical and trade schools (NAICS code 611519),
e.g., training providers.
Engineering services (NAICS code 541330) and building
inspection services (NAICS code 541350), e.g., dust sampling
technicians.
Lead abatement professionals (NAICS code 562910), e.g.,
firms and supervisors engaged in LBP activities.
Testing laboratories (NAICS code 541380) that analyze dust
wipe samples for lead.
Federal agencies that own residential property (NAICS code
92511, 92811).
Property owners, and property owners that receive
assistance through federal housing programs (NAICS code 531110,
531311).
B. What is the Agency's authority for taking this action?
EPA is finalizing this rule under sections 401, 402, 403, and 404
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). 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 (15
U.S.C. 2681), LBP hazards are defined as conditions of LBP and lead-
contaminated dust and soil that ``would result in adverse human health
effects,'' 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. . . .'' As
defined in TSCA section 401 (15 U.S.C. 2681(9)), LBP means paint or
other surface coatings that contain lead in excess of 1.0 milligrams
per centimeter squared or 0.5 percent by weight or (1) in the case of
paint or other surface coatings on target housing, such lower level as
may be established by HUD, as defined in 42 U.S.C. 4822(c), or (2) in
the case of any other paint or surface coatings, such other level as
may be established by EPA.
The amendments to the regulations on LBP activities are promulgated
pursuant to TSCA section 402 (15 U.S.C 2682). The amendments to the
regulations on the authorization of state and tribal Programs are
finalized pursuant to TSCA section 404 (15 U.S.C. 2684).
This final rule is being issued in compliance with the December 27,
2017 decision (``Opinion'') of the Ninth Circuit Court of Appeals, and
the subsequent March 26, 2018 order that directed the EPA ``to issue a
proposed rule within ninety (90) days from the filed date of this
order,'' and to ``promulgate the final rule within one year after the
promulgation of the proposed rule'' (Refs. 2 and 3).
C. What action is the Agency taking?
EPA established DLHS of 40 [mu]g/ft\2\ for floors and 250 [mu]g/
ft\2\ for window sills in a final rule entitled, ``Identification of
Dangerous Levels of Lead,'' also known as the 2001 LBP Hazards Rule
(Ref. 4). On July 2, 2018, EPA proposed to amend the DLHS and to make
no change to the definition of LBP (Ref. 5). EPA is finalizing its
proposal to lower the DLHS set by the LBP Hazards Rule from 40 [mu]g/
ft\2\ to 10 [mu]g/ft\2\ for floors, and from 250 [mu]g/ft\2\ to 100
[micro]g/ft\2\ for window sills.
EPA and HUD adopted the statutory definition of LBP in a joint
final rule entitled, ``Requirements for Disclosure of Known Lead-Based
Paint and/or Lead-Based Paint Hazards in Housing,'' also known as the
Disclosure Rule (Ref. 6). EPA is finalizing its proposal to make no
change to the current definition of LBP because, as further explained
in Unit III.B, insufficient information exists to support such a change
at this time.
D. Why is the Agency taking this action?
Reducing childhood lead exposure is an EPA priority, and EPA
continues to collaborate with our federal partners to reduce lead
exposures and to explore ways to strengthen our relationships and
partnerships with states, tribes, and localities. 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 (Lead Action Plan) (Ref. 7)
which will 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. The Lead Action Plan will
help federal agencies work strategically and collaboratively to reduce
exposure to lead and improve children's health. This final rule is a
component of EPA's prioritizing the important issue of childhood lead
exposure because dust is a significant exposure route for young
children because of their mouthing behavior and proximity to the floor.
In the 2001 LBP Hazards Rule under TSCA section 403, EPA modeled
the health implications of various dust-lead loadings and analyzed
those values against issues of practicality to determine the
appropriate standards, in accordance with the statute. At that time,
the Centers for Disease Control and Prevention (CDC) identified a test
result of 10 [mu]g/dL of lead in blood or higher in children as a
``level of concern''. Based on the available science at the time, EPA
explained that health effects at blood lead levels (BLLs) lower than 10
[micro]g/dL were ``less well substantiated.'' Further, the Agency
acknowledged that the standards were ``based on the best science
available to the Agency,'' and if new data were to become available,
EPA would ``consider changing the standards to reflect these data.''
(Ref. 4)
New data have become available since the 2001 LBP Hazards Rule that
indicates that health risks exist at lower BLLs than previously
recognized. The CDC now considers that no safe BLL in children has been
identified (Ref. 8), is no longer using the term ``level of concern,''
and is instead using the blood lead reference value (BLRV) to identify
children who have been exposed to lead and who should undergo case
management (especially assessment of sources of lead in their
environment and follow up BLL testing) (Ref. 8). The BLRV is based on
the 97.5th percentile of the U.S. population distribution of BLLs in
children ages 1-5 from the 2007-2008 and 2009-2010 National Health and
Nutrition Examination Surveys (Ref. 9).
Current best available science, which, as indicated above, has
evolved considerably since 2001, informs EPA's understanding of the
relationship between exposures to dust-lead loadings, blood lead
levels, and risk of adverse human health effects. This is summarized in
the Integrated Science Assessment for Lead, (``Lead ISA'') (Ref. 10),
which EPA released in June 2013, and the National Toxicology Program
(NTP) Monograph on Health Effects of Low-Level Lead, which was released
by the Department of Health and Human Services in June 2012 (Ref. 11).
The Lead ISA is a synthesis and evaluation
[[Page 32634]]
of scientific information on the health and environmental effects of
lead, including health effects of BLLs lower than 10 [mu]g/dL. These
effects include cognitive function decrements in children (Ref. 10).
The NTP, in 2012, completed an evaluation of existing scientific
literature to summarize the scientific evidence regarding potential
health effects associated with low-level lead exposure as indicated by
BLLs less than 10 [mu]g/dL. The evaluation specifically focused on the
life stage (childhood, adulthood) associated with these potential
health effects, as well as on epidemiological evidence at BLLs less
than 10 [mu]g/dL, because health effects at higher BLLs are well-
established. The NTP concluded that there is sufficient evidence for
risk of adverse health effects in children and adults at BLLs less than
10 [mu]g/dL, and less than 5 [mu]g/dL as well. In children, there is
sufficient evidence that BLLs less than 5 [mu]g/dL are associated with
increased diagnoses of attention-related behavioral problems, greater
incidence of problem behaviors, and decreased cognitive performance.
There is limited evidence that BLLs less than 5 [mu]g/dL are associated
with delayed puberty and decreased kidney function in children 12 years
of age and older. Additionally, the NTP concluded that there is
sufficient evidence that BLLs less than 10 [mu]g/dL are associated with
delayed puberty, decreased hearing, and reduced post-natal growth (Ref.
11).
Furthermore, the Children's Health Protection Advisory Committee
(CHPAC), a Federal Advisory Committee for EPA, has recommended ``that
EPA, in coordination with HUD, make strengthening the Lead-Based Paint
Hazards Standards for paint, dust, and soil one of its highest
priorities in the efforts to reduce children's blood lead levels.''
(Refs. 12 and 13).
Based on EPA's evaluation of the best available science, the
Agency's careful review of public comments received on the proposal, as
well as consideration of the potential for risk reduction, including
whether such actions are achievable, EPA is finalizing its proposal to
revise the DLHS to 10 [micro]g/ft\2\ for floors and 100 [micro]g/ft\2\
for window sills. This final action is informed by the achievability of
these standards in relation to their application in lead risk reduction
programs, whether lower dust-lead loadings can be reliably detected by
laboratories, resources for addressing LBP hazards, and consistency
across the federal government.
EPA did not propose to change post-abatement clearance levels in 40
CFR part 745, subpart L. In this regard, EPA believes it has reasonably
focused this rulemaking on the DLHS and the definition of LBP, which
are the two actions EPA agreed to undertake in response to the 2009
citizen petition. They were also the two actions expressly addressed in
the Ninth Circuit Court of Appeals Opinion discussed above.
Nonetheless, while this final rule does not address clearance levels,
EPA appreciates the points raised by commenters about the relationship
between the DLHS and clearance levels and EPA has initiated action on
this issue under a separate rulemaking, entitled ``Review of Post-
Abatement Clearance Levels for Dust-lead'' (RIN 2070-AK50), as noted in
the Spring 2019 Unified Agenda of Regulatory and Deregulatory Actions.
The Spring 2019 Unified Agenda also presents EPA's anticipated
publication timelines for the rulemaking that will address the
clearance levels.
To update the dust-lead clearance levels, EPA must take a number of
steps including health, exposure, and economic analyses. An analysis
estimating the health implications of possible revisions of applicable
dust-lead clearance levels will be conducted, taking into account
factors such as the locations where clearance samples are collected for
each of the various candidate clearance levels under consideration. An
economic analysis of candidate dust-lead clearance levels will be
conducted for purposes of evaluating the potential costs and benefits
of possible revisions to the clearance levels. EPA's economic analysis
will involve establishing a baseline lead hazard profile for facilities
affected by the rule based on knowledge of any applicable existing
rules and standards and levels of compliance with those rules and
standards. Candidate clearance levels will then need to be analyzed
with reference to this baseline. For this purpose, economic modeling
will be performed to link each candidate clearance level to the
associated scenario of health endpoints and their associated aggregated
``benefit'' valuations for the whole affected population. On the cost
side, using assumptions about the scope of interventions, scenarios
will be developed to measure aggregate costs of compliance for each
candidate clearance level. In addition, the economic analysis is
required in order to comply with the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1531-1538), and the Congressional Review Act (CRA) (5 U.S.C. 801
et seq.).
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. 14). The analysis focused specifically on the subset
of target housing and child-occupied facilities affected by this rule.
The analysis estimates incremental costs and benefits for two
categories of events: (1) Where dust-lead testing occurs to comply with
HUD's Lead-Safe Housing Rule and (2) where dust-lead testing occurs in
response to testing that detects an elevated blood lead level in a
child. The following is a brief outline of the estimated incremental
impacts of this rulemaking.
Benefits. This rule would reduce exposure to lead,
resulting in benefits from avoided adverse health effects. For the
subset of adverse health effects where the results were quantified, the
estimated annualized benefits are $268 million to $2.3 billion per year
using a 3% discount rate, and $58 million to $509 million using a 7%
discount rate. These benefits calculations are highly sensitive to the
discount rate used and to the range in the estimated number of lead
hazard reduction events triggered by the blood lead levels in children
who have had their blood lead levels tested. With respect to the
latter, the wide range is driven by uncertainty about specifics of
state and local regulations and about the blood lead levels at which
action might be taken. There are additional unquantified benefits due
to other avoided adverse health effects in children, including
attention-related behavioral problems, greater incidence of problem
behaviors, decreased cognitive performance, reduced post-natal growth,
delayed puberty and decreased kidney function (Ref. 11).
Costs. This rule is estimated to result in costs of $32
million to $117 million per year using either a 3% or 7% discount rate.
The cost calculations are highly sensitive to the range in the
estimated number of lead hazard reduction events triggered by children
with elevated blood lead levels.
Small entity impacts. This rule would impact approximately
15,400 small businesses of which 96% have cost impacts less than 1% of
revenues, 4% have impacts between 1% and 3%, and less than 1% have
impacts greater than 3% of revenues.
Environmental Justice and Protection of Children. This
rule would increase the level of environmental protection for all
affected populations without having any disproportionately
[[Page 32635]]
high and adverse human health or environmental effects on any
population, including any minority or low-income population or
children.
Effects on State, local, and Tribal governments. The rule
would not have any significant or unique effects on small governments,
or federalism or tribal implications.
F. Children's Environmental Health
Lead exposure has the potential to impact individuals of all ages,
but it is especially harmful to young children (Refs. 15, 16 and 17).
Exposure to lead is associated with increased risk of a number of
adverse health effects in children, including decreased cognitive
performance, greater incidence of problem behaviors, and increased
diagnoses of attention-related behavioral problems (Ref. 11).
Furthermore, floor dust in homes and child-care facilities is a
significant route of exposure for children given their mouthing
behavior and proximity to the floor. Therefore, the environmental
health or safety risk addressed by this action may have a
disproportionate effect on children (Ref. 18).
Consistent with the Agency's Policy on Evaluating Health Risks to
Children, EPA has evaluated the health effects in children of decreased
lead exposure. EPA prepared a Technical Support Document (TSD) for this
rulemaking which models the risk of adverse health effects associated
with dust-lead exposures at 19 potential candidate standards for dust-
lead levels (Ref. 18). It is important to note that the model and input
parameters have been the subject of multiple Science Advisory Board
Reviews, workshops and publications in the peer reviewed literature.
The TSD shows that health risks to young children decrease with
decreasing dust-lead levels but that no non-zero lead level, including
background levels, can be shown to eliminate health risk entirely.
Therefore, EPA considered additional factors beyond health effects
when selecting a new standard, including achievability of the standards
in lead risk reduction programs, whether lower dust-lead loadings can
be reliably detected by laboratories, resources for addressing LBP
hazards, and consistency across the federal government. Additional
information on EPA's evaluation can be found in Unit III.A.2 of this
preamble. On the basis of all these factors (including health effects),
EPA is finalizing its proposal to lower the DLHS set by the LBP Hazards
Rule to 10 [mu]g/ft\2\ for floors and 100 [micro]g/ft\2\ for window
sills.
II. Background
A. Health Effects
Lead exposure has the potential to impact individuals of all ages,
but it is especially harmful to young children (Refs. 15, 16 and 17).
Ingestion of lead-contaminated soil and dust is a major contributor to
BLLs in children, particularly those who reside in homes built prior to
1978 (Refs. 19 and 20). Infants and young children can be more highly
exposed to lead through floor dust at home and in child-care facilities
because they often put their hands and other objects that can have lead
from dust or soil on them into their mouths (Ref. 17). As mentioned
elsewhere in this final rule, data evaluated by the NTP demonstrates
that there is sufficient evidence to conclude that there are adverse
health effects associated with low-level lead exposure; there is
sufficient evidence that, in children, BLLs less than 5 [micro]g/dL are
associated with increased diagnoses of attention-related behavioral
problems, greater incidence of problem behaviors, and decreased
cognitive performance (Ref. 11). For further information about health
effects and lead exposure, see the Lead ISA (Ref. 10).
B. Federal Actions To Reduce Lead Exposures
In 1992, Congress enacted 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) (Ref. 1) in an effort to eliminate
LBP hazards. Section 1018 of Title X required EPA and HUD to promulgate
joint regulations for disclosure of any known LBP or any known LBP
hazards in target housing offered for sale or lease (known as the
Disclosure Rule) (Ref. 6). (``Target housing'' is defined in section
401(17) of TSCA, 15 U.S.C. 2681(17)). On March 6, 1996, the Disclosure
Rule was codified at 40 CFR part 745, subpart F, and requires
information disclosure activities before a purchaser or lessee is
obligated under a contract to purchase or lease target housing. Title X
amended TSCA to add a new subchapter entitled ``Title IV--Lead Exposure
Reduction.'' As defined in TSCA section 401 (15 U.S.C. 2681(9)), LBP
means paint or other surface coatings that contain lead in excess of
1.0 milligrams per centimeter squared or 0.5 percent by weight or (1)
in the case of paint or other surface coatings on target housing, such
lower level as may be established by HUD, as defined in 42 U.S.C.
4822(c), or (2) in the case of any other paint or surface coatings,
such other level as may be established by EPA.
This definition was codified as part of the Disclosure Rule (Ref.
6) at 40 CFR part 745, subpart F, and as part of the LBP Activities
Rule (Ref. 21) at 40 CFR part 745, subpart L. TSCA section 402(a)
directs EPA to promulgate regulations covering LBP activities to ensure
persons performing these activities are properly trained, that training
programs are accredited, and that contractors performing these
activities are certified. On August 29, 1996, EPA published final
regulations under TSCA section 402(a) that govern LBP inspections, risk
assessments, and abatements in target housing and child occupied
facilities (COFs) (also referred to as the LBP Activities Rule,
codified at 40 CFR part 745, subpart L) (Ref. 21). The definition of
``child-occupied facility'' is codified at 40 CFR 745.223 for purposes
of LBP activities. Regulations promulgated under TSCA section 402(a)
contain standards for performing LBP activities, taking into account
reliability, effectiveness, and safety.
TSCA section 402(c)(3) directs EPA to promulgate regulations
covering renovation or remodeling activities in target housing, public
buildings constructed before 1978, and commercial buildings that create
LBP hazards. EPA promulgated final regulations for target housing and
COFs in the Lead Renovation, Repair and Painting Rule, under TSCA
section 402(c)(3) on April 22, 2008 (also referred to as the RRP Rule,
codified at 40 CFR part 745, subpart E) (Ref. 22). The rule was amended
in 2010 (75 FR 24802) (Ref. 23) to eliminate a provision for
contractors to opt-out of prescribed work practices and in 2011 (76 FR
47918) (Ref. 24) to affirm the work practice requirements for cleaning
verification of renovated or repaired spaces, among other things. For
further information regarding lead and its health effects, and federal
actions taken to eliminate LBP hazards in housing, see the background
section of the RRP Rule.
TSCA section 403 is a related authority to carry out
responsibilities for addressing LBP hazards under the Disclosure and
LBP Activities Rules. Section 403 required EPA to promulgate
regulations that ``identify . . . lead-based paint hazards, lead-
contaminated dust, and lead-contaminated soil'' for purposes of TSCA
Title IV and the Residential Lead-Based Paint Hazard Reduction Act of
1992. LBP hazards, under TSCA section 401, 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)). TSCA section 401
defines lead-contaminated dust as ``surface dust in residential
dwellings''
[[Page 32636]]
that contains lead in excess of levels determined ``to pose a threat of
adverse health effects'' (15 U.S.C. 2681(11)). The standards
established in today's final rule under TSCA section 403 are used to
calibrate activities carried out under TSCA section 402. As such, the
utility of these standards should be considered in the context of the
activities to which they are applied.
Pursuant to TSCA section 404, provisions were made for interested
states, territories, and tribes to apply for and receive authorization
to administer their own LBP Activities and RRP programs. Requirements
applicable to state, territorial, and tribal programs are codified in
40 CFR part 745, subpart Q. As stated elsewhere in this document, EPA's
regulations are intended to reduce exposures and to identify and
mitigate hazardous levels of lead. Authorized programs must be ``at
least as protective of human health and the environment as the
corresponding federal program,'' and must provide for ``adequate
enforcement.'' See 40 CFR 745.324(e)(2).
HUD's Lead Safe Housing Rule (LSHR) is codified in 24 CFR 35,
subparts B through R. The LSHR implements sections 1012 and 1013 of
Title X. Under Title X, HUD has specific authority to control LBP and
LBP hazards in federally-assisted target housing (including COFs that
are part of an assisted target housing property covered by the LSHR,
because they are part of the common area of the property). The LSHR
aims in part to ensure that federally-owned or federally-assisted
target housing is free of LBP hazards (Ref. 25). Under the LSHR, when a
child under age six (6) with an elevated blood lead level (EBLL) is
identified, the ``designated party'' and/or the housing owner shall
undertake certain actions.
HUD amended the LSHR in 2017, lowering its standard for identifying
children with EBLLs from 20 [micro]g/dL to 5 [micro]g/dL, aligning its
standard with CDC's BLRV. The amendments also included revising HUD's
``Environmental Investigation Blood Lead Level'' (EIBLL) to the EBLL,
changing the level of investigation required for a housing unit of a
child with an EBLL to an ``environmental investigation'' and adding a
requirement for testing in other covered units when a child is
identified in a multiunit property. HUD may revisit and revise the
agency's EBLL via the notice and comment process, as provided by the
definition of EBLL in the amended rule, if it is appropriate to do so
in order to align with future changes to the blood lead level at which
CDC's BLRV recommends that an environmental intervention be conducted.
(Ref. 25).
C. Applicability and Uses of the DLHS
The DLHS reviewed in this regulation support the Lead-based Paint
Activities and Disclosure programs, and apply to target housing (i.e.,
most pre-1978 housing) and COFs (pre-1978 non-residential properties
where children under the age of 6 spend a significant amount of time
such as daycare centers and kindergartens). Apart from COFs, no other
public and commercial buildings are covered by this final rule. For
further background on the types of buildings to which lead program
rules apply, refer to the proposed and final LBP Hazards Rule (Ref. 4).
Within the scope of Title X, the DLHS support and implement major
provisions of the statute. They were incorporated into the requirements
and risk assessment work practice standards in the LBP Activities Rule.
The relationship between post-abatement clearance and the DLHS is
discussed in further detail elsewhere in this final rule. The DLHS
provide the basis for risk assessors to determine whether dust-lead
hazards are present. A risk assessment may be required where dust-lead
testing occurs to comply with the LSHR or where dust-lead testing
occurs in response to discovery of a child with a blood lead level
exceeding a federal or state threshold.
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. If LBP
hazards are found, the risk assessor will also identify acceptable
options for controlling the hazards in each property. These options
should allow the property owner to make an informed decision about what
actions should be taken to protect the health of current and future
residents. Risk assessments can only be performed by certified risk
assessors.
The risk assessment entails both a visual assessment and collection
of environmental samples. The environmental samples include, among
other things, dust samples from floors and window sills which are sent
to a laboratory recognized by EPA's National Lead Laboratory
Accreditation Program (NLLAP), as discussed in section III.A.2 for
analysis for lead. When the lab results are received, the risk assessor
compares them to the DLHS. If the dust-lead loadings from the samples
are at or above the applicable DLHS, then a dust-lead hazard is
present. Any LBP hazards found are listed in a report prepared for the
property owner by the risk assessor.
For the Disclosure Rule under section 1018 of Title X (42 U.S.C.
4852d), EPA and HUD jointly developed regulations requiring a seller or
lessor of most pre-1978 housing to disclose the presence of any known
LBP and LBP hazards to the purchaser or lessee (24 CFR part 35, subpart
A; 40 CFR part 745, subpart F). Under these regulations, the seller or
lessor also must provide the purchaser or lessee any available records
or reports ``pertaining to'' LBP, LBP hazards and/or any lead hazard
evaluation reports available to the seller or lessor (40 CFR
745.107(a)(4) and 24 CFR 35.88(a)(4)). Accordingly, if a seller or
lessor has a report showing lead is present in levels that would not
constitute a hazard, that report must also be disclosed. Thus,
disclosure is required under section 1018 even if dust and soil levels
are less than the applicable LBP hazard standard. EPA notes, however,
that with respect only to leases of target housing, disclosure is not
required in the limited circumstance where the housing has been found
to be LBP free by a certified inspector (24 CFR 35.82; 40 CFR 745.101).
D. Limitations of the DLHS
The DLHS are intended to identify dust-lead hazards when LBP risk
assessments are performed. These standards, as were those established
in 2001, are for the purposes of Title X and TSCA Title IV, and
therefore 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. See 40 CFR 745.61. These standards cannot
be used to identify housing that is free from risks from exposure to
lead, 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 increased risk of exposure. If one chooses to
apply the DLHS to situations beyond the scope of Title X, care must be
taken to ensure that the action taken in such settings is appropriate
to the circumstances presented in that situation, and that the action
is adequate to provide any necessary protection for children exposed.
The DLHS do not require the owners of properties covered by this
final rule to evaluate their properties for the presence of dust-lead
hazards, or to take action if dust-lead hazards are identified.
Although these regulations do not compel specific actions to address
identified LBP hazards, these standards are incorporated into certain
requirements mandated by state, federal, tribal, and local governments.
An important concern for EPA is that if the
[[Page 32637]]
DLHS were set too low, the resources for LBP hazard mitigation would be
distributed more broadly, diverting them from situations that present
more serious risks. However, EPA does not believe that the levels in
this final rule constrict these programs, considering the demonstrated
achievability of these levels (Ref. 26). As such, these standards are
appropriate for incorporation into the various assessment and LBP
hazard control activities to which they apply.
E. Administrative Petition and Litigation
On August 10, 2009, EPA received an administrative petition from
several environmental and public health advocacy groups requesting that
EPA amend regulations issued under Title IV of TSCA (Ref. 27). The
petitioners requested that EPA lower the Agency's DLHS issued pursuant
to section 403 of TSCA, and the dust-lead clearance levels issued
pursuant to section 402 of TSCA, from 40 [mu]g/ft\2\ to 10 [mu]g/ft\2\
or less for floors, and from 250 [mu]g/ft\2\ to 100 [mu]g/ft\2\ or less
for window sills; and to lower the definition of LBP pursuant to
section 401 of TSCA from 1 mg/cm\2\ and 0.5 percent by weight, to 0.06
percent by weight with a corresponding reduction in units of mg/cm\2\.
On October 22, 2009, EPA responded to this petition pursuant to
section 553(e) of the Administrative Procedure Act (5 U.S.C. 553(e))
(EPA 2009) (Ref. 28). EPA agreed to commence an appropriate proceeding
on the DLHS and the definition of LBP in response to the petition, but
stated that it did not commit to a particular schedule or to a
particular outcome.
In August 2016, administrative petitioners--joined by additional
citizen groups--filed a petition for writ of mandamus in the Ninth
Circuit Court of Appeals, seeking a court order finding that EPA had
unreasonably delayed in promulgating a rule to update the DLHS and the
definition of LBP under TSCA and directing EPA to promulgate a proposed
rule within 90 days, and to finalize a rule within six months. On
December 27, 2017, a panel majority of the Ninth Circuit granted the
writ of mandamus and ordered that EPA (1) issue a proposed rule within
ninety days of the date the decision becomes final and (2) issue a
final rule one year thereafter (Ref. 2). On March 26, 2018, the Panel
granted EPA's Motion for Clarification, specifying that the proposed
rule was due ninety days from the date of that order (Ref. 3). On June
22, 2018, the EPA Administrator signed and EPA announced its proposed
rule to lower the DLHS to 10 [mu]g/ft\2\ for floors and 100 [mu]g/ft\2\
for window sills and to make no change to the definition of lead-based
paint due to a lack of sufficient information to support such a change.
(Ref. 29). The proposed rule was published in the July 2, 2018 edition
of the Federal Register.
EPA is issuing this final rule in compliance with the Court's
order. Notably, the Court's majority decision suggested that EPA had
already determined that amending these regulations was necessary
pursuant to TSCA (15 U.S.C. 2687). However, EPA stated in its 2009
petition response that ``the current hazard standards may not be
sufficiently protective'' (Ref. 28) (emphasis added). With regard to
the definition of LBP, EPA had not even opined that the definition may
not be sufficiently protective. Rather, throughout the litigation, EPA
maintained that it would consider whether revision of the definition
was appropriate. Also, the sufficiency of the standards was not at
issue, as this mandamus petition was about timing, not substance and
EPA had not previously conducted the analyses required to reach a
conclusion under the statutory standard. It was not until EPA conducted
its own analyses--during this rulemaking process--that it was in a
position to express the conclusions that are set forward in this final
rule.
F. Public Comments Summary
The proposed rule provided a 45-day public comment period, ending
on August 16, 2018. EPA received 67 comments during the public comment
period. After the close of the public comment period, EPA received an
additional 13,376 comments nearly all of which were submitted as part
of a mass mail campaign. Comments were received from private citizens,
state governments, potentially affected businesses, academics, trade
associations, and environmental and public health advocacy groups. Many
commenters, including states, LBP businesses, lead poisoning prevention
advocacy groups, individuals, and academics, supported revising the
DLHS as proposed. A number of commenters suggested that EPA should
promulgate DLHS lower than the proposed levels at 10 [mu]g/ft\2\ for
floors, and 100 [mu]g/ft\2\ for window sills. Several commenters
specifically suggested that EPA should revise the DLHS for floors to 5
[mu]g/ft\2\, and/or 40 [mu]g/ft\2\ for window sills. One commenter
suggested that EPA should revise the DLHS only if the clearance levels
are revised as well. Other commenters suggested that EPA either not
revise the DLHS or revise them to levels higher than those in today's
final rule. Another commenter expressed concern with a DLHS of 10
[mu]g/ft\2\ for floors, contending that this would increase the cost of
the HUD Lead Hazard Control (LHC) grant program due to an increase in
clearance failures. Several commenters sought clarity in terms of how a
potential revision to the DLHS would affect LBP-related activities that
had already taken place or were in the process of conducting lead
hazard control activities. 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 can be found in the Response to Comments document (Ref.
30).
III. Final Rule
EPA carefully considered all public comments related to the
proposal. EPA is finalizing its proposal to lower the DLHS for floors
from 40 [mu]g/ft\2\ to 10 [mu]g/ft\2\ and its proposal to lower the
DLHS for window sills from 250 [mu]g/ft\2\ to 100 [mu]g/ft\2\.
This rule finalizes EPA's proposal to make no change to the
definition of LBP because insufficient information exists to support
such a change at this time.
A. Dust-Lead Hazard Standards
1. Approach for reviewing the dust-lead hazard standards. As EPA
explained in the 2001 LBP Hazards Rule (Ref. 4) (66 FR 1206, 1207), one
of the underlying principles of Title X is to move the focus of public
and private sector decision makers away from the mere presence of LBP,
to the presence of LBP hazards, for which more substantive action
should be undertaken to control exposures, especially to young
children. Since there are many sources of lead exposure (e.g. air,
water, diet, background levels of lead), and since, under TSCA Title
IV, EPA may only account for risks associated with paint, dust and
soil, EPA continues to believe that non-zero LBP hazard standards are
appropriate.
In the 2001 LBP Hazards Rule, EPA explained the issues and inherent
discretion involved when the Administrator identifies LBP hazards
(i.e., those conditions that cause exposure to lead ``that would result
in adverse human health effects as established by the Administrator
under this subchapter'' (TSCA section 401(10))). Of particular note,
EPA explained that the challenge to the Agency is how to deal with the
statutory criterion, ``would result in adverse human health effects.''
This is especially problematic because the statutory mandated activity
that requires EPA to choose a cutoff for when this
[[Page 32638]]
risk exists does not lend itself to a straightforward empirical
analysis that provides bright lines for decision makers. 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, it would not be appropriate to base a lead-based paint
hazard standard on any specific probability of exceeding any specific
blood-lead level. (Ref. 4).
As further explained in that 2001 LBP Hazards Rule, EPA first
determined the lowest candidate DLHS by using a 1-5% probability of an
individual child developing a BLL of 10 [mu]g/dL. EPA then took a
pragmatic approach by looking at numerous factors affected by the
candidate standards and prioritized protection from the greatest lead
risks so as not to dilute intervention resources.
To develop the DLHS proposal in 2018 (Ref. 5), EPA evaluated the
relationship between dust-lead levels and children's health, and
considered the achievability of the DLHS given the relationship between
standards established under TSCA section 403 and the application of
those standards in lead risk reduction programs. Additional factors
that the Agency considered include whether lower dust-lead loadings can
be reliably detected by laboratories, resources for addressing LBP
hazards, and consistency across the federal government.
The TSD presents models to determine the risk of adverse health
effects associated with dust-lead exposures at 19 levels (Ref. 18).
Section 6.4 of the TSD summarizes the results of the metrics of
interest, including the probability that an individual exposed to each
potential candidate standard would have a BLL above 5 [mu]g/dL.
Consistent with the establishment of the 2001 DLHS, EPA believes
national standards are still an appropriate regulatory approach because
they facilitate implementation and decrease uncertainty within the
regulated community. Furthermore, national standards are appropriate
because legacy lead paint remains in homes in most, if not all, parts
of the country. For further information, see the LBP Hazards Rule (Ref.
4).
Based on the language of sections 401, 402, and 403 of TSCA and the
purposes of Title X and its legislative history, EPA continues to
believe that it is a reasonable exercise of its discretion to set
hazard standards based on consideration of the potential for risk
reduction, including whether such actions are achievable, and with
consideration given to the existing programs aimed at achieving such
reductions. This final rule revising the DLHS to 10 [mu]g/ft\2\ for
floors and 100 [mu]g/ft\2\ for window sills is informed by the
achievability of these standards in relation to their application in
lead risk reduction programs, whether lower dust-lead loadings can be
reliably detected by laboratories, resources for addressing LBP
hazards, and consistency across the federal government. In this final
rule, the Administrator is exercising his Congressionally delegated
function to identify LBP hazards, which the statute defines as those
conditions that cause exposure to lead ``that would result in adverse
human health effects as established by the Administrator,'' in light of
the data and associated uncertainties and the statutory purpose of
targeting intervention resources towards protection against the
greatest lead risks.
EPA's hazard standards should not be considered in isolation, but
must be contemplated along with the Agency's actions to address lead in
other media. It is anticipated that this final rule, especially in
conjunction with other federal actions, will result in better health
outcomes for children. As described in the DLHS proposal in 2018 (Ref.
5), scientific advances made since the promulgation of the 2001 rule
clearly demonstrate that exposure to low levels of lead result in
adverse health effects. Moreover, since CDC has stated that no safe
level of lead in blood has been identified, the reductions in
children's BLLs as a result of this rule will help reduce the risk of
adverse cognitive and developmental effects in children.
2. Selection of final DLHS. Reducing childhood lead exposure is an
EPA priority, and today's final rule is one component of EPA's broad
effort to reduce children's exposure to lead. While no safe level of
lead in blood has been identified (Ref. 8), the reductions in
children's blood-lead levels resulting from this rule are expected to
reduce the risk of adverse cognitive and developmental effects in
children. TSCA Section 403 required EPA to promulgate regulations that
``identify . . . lead-based paint hazards, lead-contaminated dust, and
lead-contaminated soil'' for purposes of TSCA Title IV and the
Residential Lead-Based Paint Hazard Reduction Act of 1992. LBP hazards,
under TSCA section 401, 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)). TSCA section 401 defines lead-
contaminated dust 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)).
In selecting the DLHS, EPA gave significant weight to health
outcomes identified in the TSD. As the TSD shows, health risks to young
children decrease with decreasing dust-lead levels; incremental
decreases to BLL and adverse health effects are seen at all points
below the original DLHS established in 2001. Although 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. Therefore, it is appropriate for EPA to consider
factors beyond health effects when selecting new standards. Additional
factors that the Agency considered include achievability of the
standards in lead risk reduction programs, whether lower dust-lead
loadings can be reliably detected by laboratories, resources for
addressing LBP hazards, and consistency across the federal government.
EPA is concerned that if DLHS were set too low, the limited
resources for hazard mitigation would be distributed more broadly,
diverting them from vulnerable communities or situations that present
more serious risks to those that present lower risks. As described in
the Key Federal Programs to Reduce Childhood Lead Exposures and
Eliminate Associated Health Impacts document, as well as the Lead
Action Plan, national data suggest disparities persist among and within
communities due to factors such as race, ethnicity, and income (Ref.
20). In 2013-2016, the 95th percentile BLL of children ages 1 to 5
years in families with incomes below poverty level was 3.0 [mu]g/dL
(median is 0.9 [mu]g/dL,) and among those in families at or above the
poverty level it was 2.1 [mu]g/dL (median is 0.7 [mu]g/dL), a
difference that is statistically significant. In 2011-2016, 2.2% of
children in families below the poverty level had a BLL at or above 5
[mu]g/dL, compared to 0.6% of children in families at or above the
poverty level, a difference that is statistically significant. The
97.5th percentile in 2013-2016 is 3.3 [mu]g/dL, a slight decrease from
the value for 2011-2014 (Ref. 31).
As noted earlier in the preamble, EPA continues to believe that it
is a reasonable exercise of its discretion to set hazard standards
based on consideration of the potential for risk reduction, including
whether such actions are achievable, and with consideration given to
the existing programs aimed at achieving such
[[Page 32639]]
reductions. Additional factors that the Agency considered include
whether lower dust-lead loadings can be reliably detected by
laboratories, resources for addressing LBP hazards, and consistency
across the federal government. As discussed in Units I.D. and II.A.2.
of the proposal, EPA worked with HUD's Office of Lead Hazard Control
and Healthy Homes (OLHCHH) to survey the office's LHC grantees to
assess the achievability of candidate DLHS (Ref. 26). Survey results
showed that reductions in dust-lead levels to 10 [mu]g/ft\2\ on floors
and to 100 [mu]g/ft\2\ on window sills were shown to be technically
achievable using existing cleaning practices, even though, at the time,
the reductions had to be just down to 40 and 250 [mu]g/ft\2\,
respectively. As explained in the survey's final report, testing
results were collected from 1,552 housing units treated by 98 grantees,
and included 7,211 floor and 4,893 window sill dust samples. The data
were analyzed to determine the percentage of samples with dust-lead
loadings at or below various levels. For floors, 72% of samples showed
dust-lead levels at or below 5 [mu]g/ft\2\, 85% were at or below 10
[mu]g/ft\2\, 90% were at or below 15 [mu]g/ft\2\, and 94% were at or
below 20 [mu]g/ft\2\. For window sills, 87% of samples showed dust-lead
levels at or below 40 [mu]g/ft\2\, 91% were at or below 60 [mu]g/ft\2\,
96% were at or below 80 [mu]g/ft\2\, and 97% were at or below 100
[mu]g/ft\2\ (Ref. 26). This final rule revising the DLHS to 10 [mu]g/
ft\2\ for floors and 100 [mu]g/ft\2\ for window sills is informed by
the achievability of these standards in relation to their application
in lead risk reduction programs. These standards will complement other
federal actions aimed at reducing lead exposures for all children. EPA
also believes that the standards will continue to inform where
intervention resources should be directed for children with higher
exposures. These are the lowest levels that EPA believes are reliably
achievable using existing lead-hazard control practices and that are
aligned with the clearance levels required under certain HUD grant
programs. As such, these levels provide greater uniformity across the
federal government than other options suggested by commenters and
provide consistency for the regulated and public health communities.
EPA received a number of comments during the public comment period
suggesting that EPA promulgate DLHS lower than the proposed levels at
10 [mu]g/ft\2\ for floors and 100 [mu]g/ft\2\ for window sills. Several
commenters specifically suggested DLHS for floors at 5 [mu]g/ft\2\,
and/or 40 [mu]g/ft\2\ for window sills. In the TSD, EPA models the risk
of adverse health effects associated with dust-lead exposures at
differing potential candidate standards (19 options) in children living
in pre-1940 and pre-1978 housing, as well as associated potential
health effects in this subpopulation. As explained in the EPA's
proposal and section 3.2.3 of the TSD, floors have a larger impact on
children's exposure to dust lead than sills because they take up more
square footage of the housing unit and children spend more of their
time in contact with the floor rather than the sills. Consequently,
candidate standards that reduce floor dust-lead loadings more than sill
dust-lead loadings have the biggest impact on exposure because of the
greater likelihood and magnitude of children's exposure to floor dust-
lead. For example, a candidate standard of 40 [mu]g/ft\2\ for floors
and 100 [mu]g/ft\2\ for window sills is likely to be less effective
than a standard of 10 or 20 [mu]g/ft\2\ for floors and 250 [mu]g/ft\2\
for window sills.
In addition, at least one study suggests that dust-lead may
reaccumulate after LHC activities, especially when cleaning and interim
controls are used, and therefore DLHS levels lower than 100 [mu]g/ft\2\
for window sills (e.g., 40 [mu]g/ft\2\) may not be maintained over
time, and would therefore render a lower DLHS to be a less effective
indication of what property owners and residents can do to achieve a
reduction in lead exposure (Ref. 32).The study shows that after
cleaning the geometric mean dust-lead level was 45 [mu]g/ft\2\ and the
median dust-lead level was 57 [mu]g/ft\2\, both of which are slightly
above commenters' suggested window sill dust-lead level of 40 [mu]g/
ft\2\. But from six months through six years post-intervention, the
window sill dust-lead levels were well above this level. At six months
the geometric mean dust level was 105 [mu]g/ft\2\ and the median was
104 [mu]g/ft\2\, which is much closer to a DLHS for window sills at 100
[mu]g/ft\2\, rather than 40 [mu]g/ft\2\. These results call into
question whether window sill levels at or below 40 [mu]g/ft\2\ can be
maintained over time with routine cleaning practices, particularly
interim controls. These inconsistencies, along with the other concerns
discussed in this preamble, are why EPA has declined to select a lower
DLHS for window sills as suggested by the commenters.
Dust sampling is a critical element of the lead-based paint program
because it is how members of the public learn whether dust-lead hazards
are present in their homes and properties. Dust sampling is conducted
by wiping a representative surface of known area with a wet wipe and
sending the wipe to a laboratory for analysis. The laboratory that
conducts the analysis must be recognized by EPA's NLLAP. See TSCA
section 405(b), 15 U.S.C. 2685(b); 40 CFR 745.90(c)(1); 40 CFR 745.223;
40 CFR 745.227(f); 40 CFR 745.327(c). EPA's NLLAP defines the minimum
requirements and abilities that a laboratory must meet to attain EPA
recognition as an accredited lead testing laboratory in the Laboratory
Quality System Requirements (LQSR) (Ref. 33).
Several commenters expressed concern about laboratories' ability to
meet lower limits resulting from a revision to the DLHS, and one
commenter went further to recommend that EPA thoroughly examine
laboratories' ability to accurately measure at lower levels. Several
commenters specifically requested DLHS for floors at 5 [mu]g/ft\2\ and/
or 40 [mu]g/ft\2\ for window sills. EPA agrees that a thorough
understanding of laboratories' ability to meet lower LQSR limits as a
result of revised DLHS is important, especially in consideration of
commenters' suggestions for lower DLHS than were proposed and finalized
in this rule. As indicated in the proposed rule (Ref. 5), EPA continues
to believe in the importance of being able to assess whether the dust-
lead loadings reflected in the revised DLHS can be reliably measured by
laboratories. If NLLAP-recognized laboratories were unable to
demonstrate meeting the LQSR requirements, then stakeholders would be
unable to use those laboratories in conducting activities required by
EPA's LBP program. Those laboratories would either take actions to meet
the lower LQSR limits or discontinue analysis of lead dust wipe samples
from their portfolio of services. If too many laboratories were to
discontinue lead dust wipe analysis from their portfolios, it could be
problematic for the regulated community that conducts the sampling (as
well as residents, property owners, and other stakeholders), in the
form of increased cost of analysis per sample, increased waiting
periods that make testing for dust-lead hazards untenable, or a
combination of both. As the number of NLLAP-recognized labs decrease,
the potential for risk reduction is diminished.
In order to obtain a better understanding of laboratories'
capabilities and capacity for dust wipe analysis, EPA conducted
teleconferences with two accrediting organizations (Refs. 34; 35; and
36), five federally funded laboratories (Refs. 37; 38; 39; 40; and 41),
and nine state or
[[Page 32640]]
privately funded laboratories (Refs. 42; 43; 44; 45; 46; 47; 48; 49;
and 50). The clientele of the two accrediting organizations represent
99% of the laboratories recognized by NLLAP for dust-lead testing.
Fourteen teleconferences with NLLAP-recognized laboratories represent
approximately 13% of the NLLAP-recognized laboratories, and one of the
privately funded laboratory contacts with whom EPA spoke is a parent
company of sixteen (or approximately 15%) NLLAP-recognized laboratories
(Ref. 45). EPA believes the accrediting organizations and laboratories
with which teleconferences were held are representative of NLLAP-
recognized laboratories. These teleconferences further informed the
discussion below, which examines laboratory requirements and
laboratories' ability to meet those requirements, various approaches by
which laboratories can meet the lower LQSR limits, and how the
viability of those approaches changes according to the DLHS in this
final rule and why revised DLHS below those levels would impair the
potential for risk reduction.
EPA established NLLAP to recognize laboratories that demonstrate
the ability to accurately analyze paint chips, dust, or soil samples
for lead. NLLAP-recognized laboratories must follow EPA's LQSR which
identifies the limits laboratories must achieve (Ref. 33). All NLLAP-
recognized laboratories are required to demonstrate they can achieve a
quantitation limit and a method detection limit (Ref. 33), and
accrediting organizations must use the LQSR when evaluating
laboratories performing environmental testing activities under NLLAP. A
quantitation limit, also known as a reporting limit (Ref. 5) or minimum
reporting limit (Ref. 51), is the minimum level or quantity of lead
``that can be quantified to a specified accuracy.'' (Ref. 33) A method
detection limit is ``[t]he minimum concentration of [lead] that . . .
has a 99% probability of being identified, qualitatively or
quantitatively measured, and reported to be greater than zero.'' (Ref.
33) NLLAP-recognized laboratories that analyze dust wipe samples for
lead must show they can achieve a quantitation limit ``equal to or less
than . . . 50% of the lowest action level [i.e., regulatory limit] for
dust wipe samples.'' (Ref. 33) The quantitation limit must also be ``at
least 2 times but no greater than 10 times the method detection
limit.'' (Ref. 33) When this final rule becomes effective, the ``lowest
action level for dust wipe samples'' will be the DLHS for floors at 10
[micro]g/ft\2\. Therefore, as a result of this rulemaking, laboratories
that wish to maintain or obtain NLLAP recognition must be able to
demonstrate a quantitation limit equal to or less than 5 [micro]g/
ft\2\, and a method detection limit no less than 0.5 [micro]g/ft\2\ and
no greater than 2.5 [micro]g/ft\2\.
In the proposed rule, EPA requested comment on the achievability of
lower standards, including the ability of laboratories to accurately
test to lower levels, in part to gain information on how the rule would
affect the status of NLLAP-recognized laboratories. One commenter
claimed that EPA found that the proposed DLHS are ``detectable among
the labs used by'' the HUD grantees that are already subject to the
lower levels. Another commenter asserted that ``100% of the labs that
conduct lead tests are already equipped to test lead dust with lower
standards than [are] currently being used.'' EPA agrees that the final
DLHS are achievable by HUD LHC grantees but disagrees with the
commenter's assertion that ``100% of the labs that conduct lead tests
are already equipped to test'' for dust-lead at lower dust-lead levels
than the previous DLHS. As mentioned in the proposed rule, HUD's policy
guidance revision has already required its OLHCHH's LHC grantees to use
clearance levels of 10 [micro]g/ft\2\ for floors and 100 [micro]g/ft\2\
for window sills when conducting LHC activities (Ref. 51). Therefore,
100% of the laboratories used by these grantees were using laboratories
with a reporting limit equal to or less than 5 [mu]g/ft\2\. Although
this means that ``there is no technological barrier to reducing the
current standard to the'' revised DLHS, and the laboratories used by
the grantees are able to do so (Ref. 5), it does not mean that all of
the NLLAP-recognized laboratories are already able to meet the lower
LQSR limits associated with the revised DLHS. Based on EPA's additional
research, the agency believes a little less than half of NLLAP-
recognized laboratories are already able to meet the lower LQSR limits
associated with the revised DLHS. In addition, the other laboratories
that wish to maintain or obtain NLLAP recognition will need to take
actions to meet the lower LQSR limits as a result of this rulemaking
(Ref. 14). EPA also notes that if the DLHS were revised to levels lower
than this final rule, the Agency is not confident based on available
data that the laboratories used by the HUD grantees could meet the
lower LQSR limits.
There are a number of approaches by which laboratories can meet the
lower LQSR limits. These approaches, in order of increasing burden for
doing so (including financial, time, and personnel resources), are:
Instruct their customers to increase the wipe area; modify sample
preparation and revise accreditation; or acquire new instrumentation,
modify sample preparation, and revise accreditation. Through EPA's
research on laboratories' capability and capacity, EPA believes that
most if not all of the laboratories that will need to take actions to
meet the lower LQSR limits will be able to do so by instructing
customers to increase the wipe area, modifying the sample preparation
and revising accreditation, or executing some combination of those
approaches with a revised DLHS at 10 [micro]g/ft\2\ for floors and 100
[micro]g/ft\2\ for window sills (Ref. 14).
However, if EPA were to revise the DLHS to levels lower than the
levels in this final rule, the viability of those less burdensome
approaches diminishes sharply. With DLHS levels suggested by commenters
at 5 [micro]g/ft\2\ for floors, EPA estimates that a little over 40% of
the NLLAP-recognized laboratories would either have to acquire new
instrumentation, modify sample preparation, and revise accreditation,
or discontinue dust wipe analysis for lead from their portfolio (Ref.
14). As further explained in the following paragraphs, EPA is concerned
that laboratories that are faced with the decision of whether to meet
lower LQSR limits may end up discontinuing dust wipe analysis for lead
from their business models. This diminished capacity for laboratories
that perform dust wipe analysis could in turn be problematic for the
regulated community that conducts the sampling, either in the form of
increased cost of analysis per sample, increased waiting periods that
make testing for dust-lead hazards untenable, or a combination of both.
As the number of NLLAP-recognized labs decrease, this could
inadvertently put more children at risk of prolonged lead exposure.
Increasing the wipe area is a less burdensome, acceptable way that
many laboratories can meet the lower LQSR limits associated with
revisions to the DLHS in this final rule of 10 [micro]g/ft\2\ for
floors and 100 [micro]g/ft\2\ for window sills. Dust wipes are
typically used to sample a floor area of 1 ft\2\ (Ref. 52). Increasing
the wipe area will increase the amount of lead collected, making it
more likely that the dust wipe sample will be measurable above the new
quantitation limit without incurring additional expense. Some
laboratories have indicated that they are able to test such samples by
instructing their customers to wipe an area of 2 ft\2\ (Ref. 14). In
addition, several commenters relayed
[[Page 32641]]
that samples have been taken using a 2 ft\2\ wipe area, and some
laboratories have indicated that this is how they are meeting the HUD
grant policy requirements. The commenters declare that a laboratory
using less sensitive instrumentation will have difficulty meeting the
lower requirements associated with the revised DLHS without the
expansion of the wipe area. Commenters also note there have not been
any problems reported by HUD grantees concerning the increased wipe
area. Additionally, using a 2 ft\2\ wipe area satisfies EPA's LQSR
limits. A laboratory that modifies its sample preparation or
instrumentation for dust wipe analysis would have to incur the
additional burden of modifying or acquiring a new accreditation (Ref.
36), but an increase in the wipe area does not necessarily alter the
sample preparation or instrumentation. Therefore, a laboratory that
only requires increased wipe areas may not incur that additional
burden. EPA agrees with the commenters that expanding the wipe area to
2 ft\2\ can be an acceptable way for laboratories to meet the lower
requirements associated with revisions to the DLHS in this final rule.
There are several potential issues, however, with expanding the
sampling area to 4 ft\2\ (Refs. 35 and 44). First, although one
laboratory EPA contacted felt that it would be able to use its
currently less sensitive instrumentation by instructing its customers
to wipe a 4 ft\2\ area (Ref. 45), there was no consensus among the
laboratories with whom EPA spoke as to whether it is practical to
increase the sampling area to 4 ft\2\ in order to demonstrate
compliance with the LQSR if the DLHS for floors was decreased to 5
[mu]g/ft\2\ (Ref. 14). The larger wipe area could interfere with the
effectiveness of the sampling method and cause problems with
preparation procedures and laboratory instrumentation (Ref. 14).
Therefore, EPA does not believe that increasing the wipe area to 4
ft\2\ would be a good approach for laboratories faced with the decision
of how to meet the lower LQSR limits with less sensitive
instrumentation, for a DLHS level lower than 10 [micro]g/ft\2\ for
floors.
In addition, in some cases, window sills do not have enough surface
area to allow for a sampling area that is large enough to collect a
sufficient amount of dust-lead to meet all laboratories' quantitation
limits with their existing analytical equipment.
Thus, EPA believes that setting the DLHS at 10 [micro]g/ft\2\ for
floors and 100 [micro]g/ft\2\ for window sills is the best way to
maintain the current number of NLLAP-recognized laboratories by
ensuring the requirements can be implemented, which in turn helps to
maximize the potential of this rule for continued risk reduction.
With DLHS at 10 [micro]g/ft\2\ for floors, laboratories that are
not able to meet the LQSR limits by simply increasing the wipe area,
due to their own variable processes and equipment, should be able to do
so by modifying the sample preparation and revising their accreditation
to meet new testing limits. There are several potential changes
laboratories can make to modify their sample preparation that might
allow a laboratory to lower its quantitation limit and method detection
limit while using the same analytical instrumentation. To analyze dust
wipe samples, laboratories take the dust wipe, heat it in a solution,
and then analyze that solution for lead. Hence, increasing the
concentration of lead in the digestate will facilitate achieving
measurements above the quantitation limit without acquiring new
instrumentation. This can be accomplished by reducing the final volume
by using a higher acid concentration or evaporating the digestate and
thereby the final concentration of lead for analysis. Additionally,
laboratories may be able to use different equipment for heating the
solution that would allow use of a lower volume of the digestate.
Laboratories that institute these modifications would not need to start
from scratch with an entirely new accreditation, but would have to
modify their existing accreditation to maintain NLLAP recognition.
However, these modifications to sample preparation have their limits.
Several of the laboratories that EPA talked to indicated that these
modifications would become less viable if the DLHS were to decrease
below the levels in this final rule.
If the DLHS were set to levels lower than 10 [micro]g/ft\2\ for
floors and 100 [micro]g/ft\2\ for window sills, EPA believes that an
increasing number of the laboratories that need to take actions to meet
the lower LQSR limits will have to use a different type of analytical
instrument that is more sensitive, especially if the DLHS were set to 5
[micro]g/ft\2\ for floors and 40 [micro]g/ft\2\ for window sills, as
some commenters requested. The majority of the laboratories that would
have to use a different type of analytical instrument would have to
purchase new instrumentation and revise their accreditation. This
accreditation revision would likely have to include an on-site
inspection from an accreditation body (Ref. 36). One commenter
mentioned that if new instrumentation were required, such an upgrade
could cost between $80,000-$250,000, ``not including many consumable
materials and retrofitting the laboratory for the equipment.'' EPA
agrees with the commenter that the expense of new instrumentation can
be significant, and notes that from its own research, the time required
to purchase the new equipment, have it installed, run validation
studies, optimize the methods and train personnel on its use, and then
to revise the accreditation with an on-site inspection can be quite
disruptive to a laboratory's operations. This is especially true for
smaller laboratories with more limited resources. As more laboratories
conclude that they must acquire new instrumentation and revise their
accreditation with an on-site inspection, the likelihood of more
laboratories discontinuing dust wipe analysis from their portfolios
increases.
After the promulgation of this final rule lowering the DLHS,
laboratories that need to take actions to meet the lower LQSR limits
will have to take time to review their situation, determine the changes
they need to make, decide whether they want to continue in the NLLAP
program, and select among the approaches previously described. For DLHS
lower than 10 [micro]g/ft\2\ for floors, the number of laboratories
that would need to acquire new instrumentation, modify sample
preparation, and revise their accreditation with an on-site inspection
increases, which would take the most time and resources to accomplish.
Laboratories that are faced with the decision to either take these
actions or discontinue dust wipe analysis for lead from their
portfolios, are much more likely to discontinue the analysis from their
portfolios if they cannot simply increase the wipe area or modify their
sample preparation. Based on EPA's research on laboratories'
capabilities and capacity, EPA believes more laboratories may
discontinue dust wipe analysis for lead from their portfolios if the
DLHS were set lower than in this final rule. For these reasons, in
addition to those discussed earlier in section III.A.(2), EPA believes
it is within its discretion to set the DLHS at 10 [micro]g/ft\2\ for
floors and 100 [micro]g/ft\2\ for window sills in consideration of the
potential for risk reduction, including whether such actions are
achievable in relation to their application in lead risk reduction
programs.
3. Effect of this change on EPA and HUD Programs. a. EPA Risk
Assessments. As stated earlier in this preamble, EPA's risk assessment
work practice standards provide the basis for risk assessors to
determine whether LBP hazards are present in target housing
[[Page 32642]]
and COFs. As part of a risk assessment, dust samples are taken from
floors and window sills to determine if dust-lead levels exceed the
DLHS. Results of the sampling, among other things, are documented in a
risk assessment report which is required under the LBP Activities Rule
(Ref. 21). In addition to the sampling results, the report must
describe the location and severity of any dust-lead hazards found and
describe interim controls or abatement measures needed to address the
hazards. Under the LBP Activities Rule, risk assessors will compare
dust sampling results for floors and window sills to the new, lower
DLHS from this rule. Sampling results above the new hazard standard
will indicate that a dust-lead hazard is present on the surfaces
tested. EPA expects that this will result in more hazards being
identified in a portion of target housing and COFs that undergo risk
assessments. The final rule does not change any other risk assessment
requirements.
b. EPA-HUD Disclosure Rule. Under the Disclosure Rule (Ref. 6),
prospective sellers and lessors of target housing must provide
purchasers and renters with a federally approved lead hazard
information pamphlet and disclose known LBP and/or LBP hazards. The
information disclosure activities are required before a purchaser or
renter is obligated under a contract to purchase or lease target
housing. Records or reports pertaining to LBP or LBP hazards must be
disclosed, including results from dust sampling regardless of whether
the level of dust-lead is below the hazard standard. For this reason,
the lower dust-lead hazard standard will not result in more information
being disclosed because property owners would already be disclosing
results that show dust-lead below the original DLHS of 40 [micro]g/
ft\2\ on floors or below 250 [micro]g/ft\2\ on window sills. However, a
lower dust-lead hazard standard may prompt a different response on the
lead disclosure form, i.e., that a lead-based paint hazard is present
rather than not, which will occur when a dust-lead level is below the
original standard but at or above the standard in this final rule.
c. Renovation, Repair and Painting (RRP) Rule. To avoid confusion
about the applicability of this final rule, EPA notes that revising the
DLHS will not trigger new requirements under the existing RRP Rule. The
existing RRP work practices are required where LBP is present (or
assumed to be present), and are not predicated on dust-lead loadings
exceeding the hazard standards. The existing RRP regulations do not
require dust sampling prior to or at the conclusion of a renovation
and, therefore, will not be directly affected by this change to the
DLHS.
d. HUD Requirements for Federally-assisted or Federally-owned
housing. Under sections 1012 and 1013 of Title X, HUD established LBP
hazard notification, evaluation, and reduction requirements for certain
pre-1978 HUD-assisted and federally-owned target housing, known as the
Lead Safe Housing Rule (LSHR). See 24 CFR part 35, subparts B through
R. The programs covered by these requirements range from supportive
housing services to foreclosed HUD-insured single-family insured
housing to public housing. For programs where hazard evaluation is
required, the DLHS provide criteria to risk assessors for identifying
LBP hazards in residences covered by these programs. For programs that
require abatement of LBP hazards, the DLHS are used to identify
residences that contain dust-lead hazards as part of determining where
abatement will be necessary.
e. HUD Guidelines. The HUD Guidelines for the Evaluation and
Control of Lead-Based Paint Hazards in Housing were developed in 1995
under section 1017 of Title X. They provide detailed, comprehensive,
technical information on how to identify LBP hazards in residential
housing and COFs, and how to control such hazards safely and
efficiently. The Guidelines were revised in 2012 to incorporate new
information, technological advances, and new federal regulations,
including EPA's LBP hazard standards. Based on EPA's changes in this
final rule, HUD plans to revise Chapter 5 of the Guidelines on risk
assessment and reevaluation and Chapter 15 on clearance based on those
changes.
f. LSHR Clearance Requirements. While this final rule does not
change the clearance levels under EPA's regulations, it will have the
effect of changing the clearance levels that apply to hazard reduction
activities under HUD's LSHR. The LSHR requires certain hazard reduction
activities to be performed in certain federally-owned and assisted
target housing including abatements, interim controls, paint
stabilization, and ongoing LBP maintenance. Hazard reduction activities
are required in this housing when LBP hazards are identified or when
maintenance or rehabilitation activities disturb paint known or
presumed to be LBP. The LSHR's clearance regulations, 24 CFR 35.1340,
specify requirements for clearance of these projects (when they disturb
more than de minimis amounts of known or presumed lead-based painted
surfaces, as defined in 24 CFR 35.1350(d)), including a visual
assessment, dust sampling, submission of samples for analysis for lead
in dust, interpretation of sampling results, and preparation of a
report. Clearance testing of abatements and non-abatements is required
by 24 CFR 35.1340(a) and (b), respectively.
The LSHR's clearance regulations cross-reference regulatory
provisions to establish clearance levels for abatements that are
different than those for non-abatement activities. The LSHR clearance
regulations for both abatements and non-abatement activities, at 24 CFR
35.1340(d), cross-reference the standards, at 24 CFR 35.1320(b), to be
used by risk assessors for conducting clearance; in turn, the standards
at 24 CFR 35.1320(b) cross-reference EPA's DLHS at 40 CFR 745.227(h).
In addition, the LSHR clearance regulations for abatements, at 24 CFR
35.1340(a), which set forth that clearance must be performed in
accordance with EPA regulations, cross-reference EPA's clearance
standards for abatements at 40 CFR 745.227(e). Because the EPA's DLHS
and dust-lead clearance standards for abatements were the same, cross-
referencing different EPA regulatory provisions, at 40 CFR 745.227(e)
and (h), had no effect on hazard reduction activities under the LSHR.
The LSHR clearance regulations for non-abatement activities, at 24
CFR 35.1340(b) do not cross-reference EPA's clearance standards at 40
CFR 745.227(e). Only EPA's DLHS at 40 CFR 745.227(h) are referenced at
24 CFR 1340(d) as the clearance standards for non-abatement activities,
because EPA does not have its own clearance standards for them.
Accordingly, as explained in the proposed rule, non-abatement
activities under the LSHR must be cleared using the EPA's DLHS when
this final rule becomes effective.
EPA's LBP activities regulations on work practice requirements, at
40 CFR 745.65(d), specify that clearance requirements applicable to LBP
hazard evaluation and hazard reduction activities are found in both the
LSHR, at 24 CFR part 35, subpart R, and EPA regulations at 40 CFR part
745, subpart L. For abatements covered by both agencies' regulations,
the LSHR regulations, at 24 CFR 35.145 and 35.1340(a), require
clearance levels following abatement of LBP or LBP hazards to be at
least as protective as EPA's clearance levels for abatements at 40 CFR
745.227(e).
This final rule revises the DLHS from 40 [micro]g/ft\2\ and 250
[micro]g/ft\2\ to 10 [micro]g/ft\2\ and 100 [micro]g/ft\2\ on floors
and window sills, respectively. As a result of this final action, EPA's
DLHS will be lower than EPA's clearance standards for
[[Page 32643]]
abatements, and according to HUD, abatements under HUD's LSHR will be
cleared using the EPA's DLHS.
g. Effects of a Revision on Previous LBP-related Activities. Since
the DLHS do not compel specific actions, revisions to the DLHS would
not in and of themselves retroactively compel actions. Inspection
reports and risk assessments describe conditions at a specific time. A
report that indicates no presence of LBP and/or a LBP hazard should not
imply the absence of those conditions in perpetuity. In addition, this
rulemaking by itself does not impose retroactive requirements to
regulated entities that have previously complied with the disclosure
rule. A seller or lessor must properly disclose any available records
or reports pertaining to LBP, LBP hazards and/or any lead hazard
evaluative reports ``before the purchaser or lessee is obligated under
any contract to purchase or lease target housing that is not otherwise
an exempt transaction pursuant to Sec. 745.101'' (40 CFR 745.107). The
seller or lessor is not required to disclose reports or records that
may be created in the future, after the close of that transaction, in
perpetuity. Additionally, any LBP-free certification that was issued by
a certified inspector, based on the previous DLHS, and was issued
before the effective date of this rulemaking, is still valid going
forward and may continue to be used for exemption to the disclosure
rule. However, the DLHS are incorporated into requirements mandated by
state, federal, tribal, and other programs that may require actions
based on the revised DLHS. Those other authorities may want to consider
guidance or other communications with their regulated communities, so
those entities understand how to comply with the various programs that
reference the DLHS. A more comprehensive version of EPA's response on
these issues can be found in section 2.c. of the response to comments
document. (Ref. 30).
B. The Definition of Lead-Based Paint
As noted in the preamble, EPA has neither opined nor concluded that
the definition of LBP may not be sufficiently protective. In response
to the administrative petition (Ref. 28) and throughout the litigation,
EPA maintained that it necessarily would first consider whether
revision to the definition of LBP was appropriate. In the proposed
rule, EPA requested comment on making no change to the definition of
LBP.
The definition of LBP is incorporated throughout EPA's LBP
regulations, and application of this definition is central to how EPA's
LBP program functions. EPA believes that accounting for feasibility and
health effects would be appropriate when considering a revision. Given
the current, significant data gaps presented below and the new
approaches that would need to be devised to address them, EPA continues
to lack sufficient information to conclude that the current definition
requires revision or to support any specific proposed change to the
definition of LBP. Some commenters in support of changing the
definition of LBP discussed paint itself as a hazard, advocating for
analysis separate and distinct from the causal relationship between LBP
and dust-lead hazards. One commenter declared that, given examples of
an independent paint-lead hazard, the current definition is ``clearly
inadequate.'' EPA reviewed these comments and has expanded the
discussion of data gaps elsewhere in the preamble to include direct
ingestion of paint. EPA did not receive any data during the public
comment period to further inform whether a revision to the current
definition of LBP is warranted or even possible at this time.
Evaluating whether revising the definition of LBP is appropriate
requires analyzing levels of lead in paint that are lower than what was
examined previously by EPA and other federal agencies. In the proposal,
EPA requested any new available data or analyses of the relationship
among levels of lead in paint, dust and risk of adverse health effects.
Although some commenters supported updating the definition of LBP and/
or said that the current level is inadequate, EPA did not receive data
or analyses that would further inform whether a revision to the
definition is warranted at this time. More information is needed to
establish a statistically valid causal relationship between
concentrations of lead in paint (lower than the current definition) and
dust-lead loadings which 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 technology would be affected under a possible revision to
the definition.
1. Relationship among lead in paint, environmental conditions, and
exposure. EPA would need to further explore the availability and
application of statistical modeling approaches that establish robust
linkages between the concentration of lead in paint below the current
definition and dust-lead on floors before EPA could develop a
technically supportable proposal to revise the definition of LBP based
on this route of exposure. To that end, EPA is coordinating with HUD to
evaluate available data and approaches. Efforts suggest that most
available empirical data and modeling approaches are only applicable at
or above the current LBP definition (0.5% and 1 mg/cm\2\). The highest
dust-lead loadings from LBP are expected to be a result of paint
removal activities during renovation. During renovation, LBP may be
disturbed and abraded, leading to elevated dust-lead loading available
for incidental ingestion. EPA developed a model to estimate lead-based
dust loadings from renovation activities in various renovation
scenarios in 2014 and a similar model was developed in 2011 by Cox et
al. However, the underlying data that supported EPA's 2014 model for
LBP was EPA's 2007 dust study, which included concentrations of lead in
paint ranging from 0.8% to 13% by weight. The data that supported Cox
et al. 2011 ranged from 0.7 to 13.2 mg/cm\2\ (converted to
approximately 0.6% to 31% by weight) of lead in paint (Refs. 53; 54;
and 55). Given that the range of concentrations that support these
models are well above the petitioners' requested concentration of lead
in paint, there would be significant uncertainty associated with using
these models to make predictions regarding lead in paint at
concentrations an order of magnitude below the current definition.
In an attempt to address this uncertainty and build a modeling
approach, EPA conducted a literature search for studies that co-report
lead concentrations in paint and dust in order to identify available
data (Ref. 53). Among other things, EPA looked to the literature to
establish statistically valid associations between low concentrations
of LBP and lead in dust, but was unable to find sufficient information
to estimate concentrations of lead in household dust from paint
concentrations below 0.8% by weight. Thus, EPA still needs to consider
generation of new data, since, as discussed elsewhere in this document,
EPA believes there is significant uncertainty associated with
estimating dust-lead loadings for levels of lead in paint up to an
order of magnitude lower than levels in the current definition using
the existing models (Ref. 53), Cox et al. (Ref. 54). Such data is
needed for EPA to develop an approach to estimate dust-lead from lower
levels of lead in paint so that EPA could estimate incremental blood
lead changes and associated health effects changes as described in the
existing dust-lead
[[Page 32644]]
approach. This may involve conducting laboratory or field studies to
characterize the relationship between LBP and dust-lead at lower levels
of lead in paint (<0.5%) (Ref. 53).
2. Quantify exposure from direct paint ingestion. EPA would need to
understand and develop an approach for estimating the amount of direct
paint consumption and subsequent exposure by children before EPA could
develop a technically supportable proposal to revise the definition of
LBP based on ingestion of paint chips and direct teething of painted
surfaces. Past studies have documented pica behavior as a risk factor
for exposure to lead from LBP, however these studies have not provided
a quantitative estimate of paint ingestion. Epidemiological studies
generally rely on caregiver observations to classify whether a child
has ever been known to consume paint chips. As described further in the
Definition of Lead-Based Paint Considerations (Ref. 53), past studies
estimate that a fraction of young children are known to have directly
ingested paint, and published case studies of individual children
provide radiographic evidence of paint chip ingestion. However, neither
provide quantitative estimates of the amount of LBP ingested over time
by children, information which is needed to quantify exposure.
3. Feasibility. In the proposal, EPA requested any new available
data on the technical feasibility of a revised definition of LBP. EPA
lacks sufficient information to support a change to the definition of
LBP with respect to feasibility. Significant data gaps prevent the
Agency from evaluating and subsequently determining that a change to
the existing definition is warranted. EPA did not receive any comments
with substantive information about whether portable field technologies
utilized in EPA's LBP Activities and RRP programs, as well as HUD's
LSHR, perform reliably at significantly lower concentrations of lead in
paint.
Portable X-ray fluorescence (XRF) LBP analyzers are the primary
analytical method for inspections and risk assessments in housing
because they can be used to quickly, non-destructively and
inexpensively determine if LBP is present on many surfaces. These
measurements do not require destructive sampling or paint removal.
Renovation firms may also hire inspectors or risk assessors to conduct
XRF testing to identify the presence of LBP. When using XRF technology,
the instrument exposes the substrate being tested to electromagnetic
radiation in the form of X-rays or gamma radiation. In response to
radiation, the lead present in the substrate emits energy at a fixed
and characteristic level. The emission is called ``X-Ray
Fluorescence,'' or XRF (Ref. 52).
XRF Performance Characteristic Sheets (PCS) have been developed by
HUD and/or EPA for most commercially available XRF analyzers (XRFs). In
order to comport with the HUD Guidelines for the Evaluation and Control
of Lead-Based Paint Hazards in Housing, an XRF instrument that is used
for testing paint in target housing or pre-1978 COFs must have a HUD-
issued XRF PCS. XRFs must be used in accordance with the manufacturer's
instructions and the PCS. The PCS contains information about XRF
readings taken on specific substrates, calibration check tolerances,
interpretation of XRF readings, and other aspects of the model's
performance. For every XRF analyzer evaluated by EPA and/or HUD, the
PCS defines acceptable operating specifications and procedures. The
ranges where XRF results are positive, negative or inconclusive for
LBP, the calibration check tolerances, and other important information
needed to ensure accurate results are also included in the PCS. An
inspector and risk assessor must follow the XRF PCS for all LBP
activities, and only devices with a posted PCS may be used for LBP
inspections and risk assessments (Ref. 52).
XRF analyzers and their corresponding PCS sheets were developed to
be calibrated with the current definition of LBP. Therefore, these
instruments would need to be re-evaluated to determine the capabilities
of each instrument model available in the market to meet a potentially
revised definition of LBP, and the corresponding PCS would need to be
amended accordingly. If, as a result of a revised definition of LBP,
the use of XRFs suddenly became unavailable, the effectiveness of the
LBP activities programs would be severely harmed. Since these
instruments are the primary analytical method for inspections and risk
assessments performed pursuant to the LBP activities regulations, EPA
would need to understand how a potential revision to the definition of
LBP would affect the ability of the regulated community to use this
technology.
When conducting renovations, contractors must determine whether or
not their project will involve LBP, and thus fall under the scope of
the RRP regulations under 40 CFR part 745, subpart E, or in certain
jurisdictions, authorized state and Indian tribal programs under
subpart Q (see Unit III.C). Under the RRP rule, renovators have the
flexibility to choose among four strategies: Use (1) a lead test kit,
(2) an XRF instrument, (3) paint chip sampling to indicate whether LBP
is present; or (4) assume that LBP is present and follow all the work-
practice requirements. For those using lead test kits, only test kits
recognized by the EPA can be used for this purpose. EPA-recognized lead
test kits used for the RRP program were evaluated through EPA's
Environmental Technology Verification (ETV) Program or by the National
Institute of Standards and Technology. ETV was a public-private
partnership between EPA and nonprofit testing and evaluation
organizations that verified the performance of innovative technologies.
ETV evaluated the reliability of the technology used for on-site
testing of LBP at the regulated level, under controlled conditions in a
laboratory. ETV ended operations in early 2014. EPA would need to
evaluate lead test kits using ETV-equivalent testing for a potential
revision of the definition of LBP. This would allow EPA to evaluate the
reliability of test kits for testing LBP under controlled conditions at
levels lower than the current LBP definition, so contractors could
continue to use this important tool in compliance with the RRP
regulations.
The regulated community uses XRF analyzers for inspections and risk
assessments and uses lead test kits to determine the presence of LBP
during renovations. In consideration of any potential revised
definition of LBP, EPA would need to fully understand the repercussions
of such a revision on these portable field technologies in order to
ensure the technological feasibility of any new revision. The methods
EPA would need to employ to do so would involve complex processes that
include evaluating the potential ability of XRF analyzers to detect LBP
at lower levels than the current definition, the ability to recalibrate
performance characteristic sheets for each available model of XRF
analyzer, and re-evaluating lead test kits under controlled conditions
in a laboratory. EPA currently lacks sufficient information to support
such an undertaking.
C. State Authorization
Pursuant to TSCA section 404, a provision was made for interested
states, territories and tribes to apply for and receive authorization
to administer their own LBP activities programs, as long as their
programs are at least as protective of human health and the environment
as the Agency's program and provides adequate enforcement.
[[Page 32645]]
The regulations applicable to state, territorial and tribal programs
are codified at 40 CFR part 745, subpart Q. As part of the
authorization process, states, territories and tribes must demonstrate
to EPA that they meet the requirements of the LBP Activities Rule. Over
time, the Agency may make changes to these requirements. To address the
changes in this final rule and future changes to the LBP Activities
Rule, the Agency is requiring states, territories and tribes to
demonstrate that they meet any new requirements imposed by this
rulemaking in order to maintain or obtain authorization. Under this
requirement, authorized states, territories and tribes have up to two
years to demonstrate that their programs include any new requirements
that EPA promulgates. A state, territory or tribe must indicate that it
meets the requirements of the LBP Activities program in its application
for authorization or, if already authorized, in a report it must submit
in accordance with 40 CFR 745.324(h) no later than two years after the
effective date of the new requirements. If an application for
authorization has been submitted but not yet approved, the state,
territory or tribe must demonstrate that it meets the new requirements
by either amending its application, or in a report it submits under 40
CFR 745.324(h) no later than two years after the effective date of the
new requirements. The Agency believes that this requirement allows
sufficient time for states, territories and tribes to demonstrate that
their programs contain requirements at least as protective as any new
requirements that EPA may promulgate.
D. Effective Date
EPA has considered the impacts of the revised DLHS on NLLAP-
recognized laboratories. This rule will become effective on January 6,
2020 in order to provide a reasonable amount of time for NLLAP-
recognized laboratories to take actions to meet the lower LQSR limits
so they can continue providing dust wipe testing services to the
regulated community at the time the rule becomes effective.
In order to obtain a better understanding of laboratories'
capability and capacity for dust wipe analysis, EPA conducted
teleconferences with two accrediting organizations (Refs. 34; 35; and
36), five federally funded laboratories (Refs. 37; 38; 39; 40; and 41),
and nine state or privately funded laboratories (Refs. 42; 43; 44; 45;
46; 47; 48; 49; and 50). Based on these conversations, EPA estimated
that over half of accredited laboratories would have to take actions to
meet the lower LQSR limits. They can accomplish this by asking their
customers to increase the wipe area sampled and/or revising their
operating procedures, validating the changes, and revising their
accreditation accordingly. Such actions can take months to complete.
EPA therefore believes that the effective date provides needed
flexibility for laboratories while ensuring that the revised DLHS
become effective in a timely manner.
IV. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. Public Law 102-550, Title X--Housing and Community Development
Act, enacted October 28, 1992 (also known as the Residential Lead-
Based Paint Hazard Reduction Act of 1992 or ``Title X'') (42 U.S.C.
4851 et seq.).
2. U.S. Court of Appeals for the Ninth Circuit. A Community Voice v.
EPA, No. 16-72816, Opinion. December 27, 2017.
3. U.S. Court of Appeals for the Ninth Circuit. A Community Voice v.
EPA, No. 16-72816, Order. March 26, 2018.
4. EPA. Lead; Identification of Dangerous Levels of Lead; Final
Rule. Federal Register (66 FR 1206, January 5, 2001) (FRL-6763-5).
5. EPA. Review of the Dust-Lead Hazard Standards and the Definition
of Lead-Based Paint; Proposed Rule. Federal Register (83 FR 30889,
July 2, 2018) (FRL-9976-04).
6. HUD, EPA. Lead; Requirements for Disclosure of Known Lead-Based
Paint and/or Lead-Based Paint Hazards in Housing; Final Rule.
Federal Register (61 FR 9064, March 6, 1996) (FRL-5347-9).
7. President's Task Force on Environmental Health Risks and Safety
Risks to Children. Federal Action Plan to Reduce Childhood Lead
Exposures and Associated Health Impacts. December 2018. https://www.epa.gov/lead/federal-action-plan-reduce-childhood-lead-exposure.
8. CDC. CDC Response to Advisory Committee on Childhood Lead
Poisoning Prevention Recommendations in ``Low Level Lead Exposure
Harms Children: A Renewed Call of Primary Prevention.'' June 7,
2012. https://www.cdc.gov/nceh/lead/acclpp/cdc_response_lead_exposure_recs.pdf.
9. CDC. Blood Lead Levels in Children Aged 1-5 Years--United States,
1999-2010. CDC Morbidity and Mortality Weekly Report, Vol. 62 No.
13, April 5, 2013. https://www.cdc.gov/mmwr/pdf/wk/mm6213.pdf.
10. EPA. Integrated Science Assessment (ISA) for Lead (Final Report,
Jul 2013). U.S. EPA, Washington, DC, EPA/600/R-10/075F, 2013.
https://cfpub.epa.gov/ncea/isa/recordisplay.cfm?deid=255721.
11. HHS, National Toxicology Program. NTP Monograph on Health
Effects of Low-Level Lead. National Institute of Environmental
Health Sciences, Research Triangle Park, NC. NIH Pub. No. 12-5996.
ISSN 2330-1279. June 13, 2012. https://ntp.niehs.nih.gov/ntp/ohat/lead/final/monographhealtheffectslowlevellead_newissn_508.pdf.
12. Children's Health Protection Advisory Committee (CHPAC). Letter
to Lisa P. Jackson RE: Childhood Lead Poisoning Prevention. March
29, 2012. https://www.epa.gov/sites/production/files/2015-10/documents/chpac_lead_letter_2012_03_29.pdf.
13. CHPAC. Letter to Scott Pruitt RE: Highest Priorities for
Childhood Lead Exposure Prevention. March 24, 2017. https://www.epa.gov/sites/production/files/2017-04/documents/2017.03.24_chpac_lead_hazard_reduction_letter.pdf.
14. EPA, Office of Pollution Prevention and Toxics. Economic
Analysis of the Final Rule to Revise the TSCA Dust-Lead Hazard
Standards. June 2019.
15. CDC. Lead Poisoning in Children (February 2011). https://www.cdc.gov/healthcommunication/toolstemplates/entertainmented/tips/LeadPoisoningChildren.html.
16. Agency for Toxic Substances and Disease Registry, Division of
Toxicology and Human Health Sciences. Lead--ToxFAQsTM CAS
# 7439-92-1, August 2007. https://www.atsdr.cdc.gov/toxfaqs/tfacts13.pdf.
17. EPA. Exposure Factors Handbook Chapter 5 (Update): Soil and Dust
Ingestion. U.S. EPA Office of Research and Development, Washington,
DC, EPA/600/R-17/384F, 2017. https://cfpub.epa.gov/ncea/risk/recordisplay.cfm?deid=236252.
18. EPA, Office of Pollution Prevention and Toxics. Technical
Support Document for Residential Dust-lead Hazard Standards
Rulemaking Approach taken to Estimate Blood Lead Levels and Effects
from Exposures to Dust-lead. June 2019.
19. Zartarian, V., Xue, J., Tornero-Velez, R., & Brown, J.
Children's Lead Exposure: A Multimedia Modeling Analysis to Guide
Public Health Decision-Making. Environmental Health Perspectives,
125(9), 097009-097009. September 12, 2017. https://doi.org/10.1289/EHP1605.
20. President's Task Force on Environmental Health Risks and Safety
Risks to Children. Key Federal Programs to Reduce Childhood Lead
Exposures and Eliminate Associated Health Impacts. November 2016.
https://ptfceh.niehs.nih.gov/features/assets/files/key_federal_programs_to_reduce_childhood_lead_exposures_and_eliminate_associated_health_impactspresidents_508.pdf.
21. EPA. Lead; Requirements for Lead-Based Paint Activities in
Target Housing and
[[Page 32646]]
Child-Occupied Facilities; Final Rule. Federal Register (61 FR
45778, August 29, 1996) (FRL-5389-9).
22. EPA. Lead; Renovation, Repair, and Painting Program; Final Rule.
Federal Register (73 FR 21692, April 22, 2008) (FRL-8355-7).
23. EPA. Lead; Amendment to the Opt-Out and Recordkeeping Provisions
in the Renovation, Repair, and Painting Program; Final Rule. Federal
Register (75 FR 24802, May 6, 2010) (FRL-8823-7).
24. EPA. Lead; Clearance and Clearance Testing Requirements for the
Renovation, Repair, and Painting Program; Final Rule. Federal
Register (76 FR 47918, August 5, 2011) (FRL-8881-8).
25. HUD. Requirements for Notification, Evaluation and Reduction of
Lead-Based Paint Hazards in Federally Owned Residential Property and
Housing Receiving Federal Assistance; Response to Elevated Blood
Lead Levels; Final Rule. Federal Register (82 FR 4151, January 13,
2017) (FR-5816-F-02).
26. HUD, Office of Lead Hazard Control and Healthy Homes. Lead
Hazard Control Clearance Survey. Final Report. October 2015. https://www.hud.gov/sites/documents/CLEARANCESURVEY_24OCT15.PDF.
27. Sierra Club et al. Letter to Lisa Jackson RE: Citizen Petition
to EPA Regarding the Paint and Dust Lead Standards. August 10, 2009.
https://www.epa.gov/sites/production/files/2015-10/documents/epa_lead_standards_petition_final.pdf.
28. EPA. Letter in response to citizen petition under section 553(e)
of the Administrative Procedure Act (5 U.S.C. 553(e)). October 22,
2009.
29. EPA. News Releases from Headquarters: Chemical Safety and
Pollution Prevention (OCSPP). EPA Proposes Strengthening the Dust-
Lead Hazard Standards to Reduce Exposures to Children. June 22,
2018. https://www.epa.gov/newsreleases/epa-proposes-strengthening-dust-lead-hazard-standards-reduce-exposures-children.
30. EPA. Review of The Dust-Lead Hazard Standards and the Definition
of Lead-Based Paint. Response to Public Comments. June 2019.
31. CDC, National Center for Health Statistics. National Health and
Nutrition Examination Survey: Questionnaires, Datasets, and Related
Documentation. https://wwwn.cdc.gov/nchs/nhanes/Default.aspx.
Accessed March 22, 2019.
32. Wilson, J., et al. Evaluation of HUD-funded lead hazard control
treatments at 6 years post-intervention. 102 Environmental Research
237-248. June 5, 2006. https://pdfs.semanticscholar.org/8742/4e5649d22b93d9b1265178e118716d5147fa.pdf.
33. EPA. EPA National Lead Laboratory Accreditation Program.
Laboratory Quality System Requirements (LQSR), Revision 3.0.
November 5, 2007. https://www.epa.gov/lead/national-lead-laboratory-accreditation-program-laboratory-quality-system-requirements-revision.
34. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and A2LA. September 21, 2018.
35. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and American Industrial Hygiene Association.
September 4, 2018.
36. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and American Industrial Hygiene Association.
September 26, 2018.
37. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and Lawrence Livermore National Laboratory.
October 11, 2018.
38. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and Navy & Marine Corp Public Health Center.
October 30, 2018.
39. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and Navy Environmental & Preventative
Medicine, Unit 2 CIHL. October 31, 2018.
40. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and Norfolk Naval Shipyard, Environmental
Chemistry Laboratory. October 25, 2018.
41. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and US Army Public Health Center, Aberdeen
Proving Ground. October 18, 2018.
42. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and ACT Environmental Services, Inc. November
15, 2018.
43. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and Atlas Environmental Laboratory. November
6, 2018.
44. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and Eastern Analytical Services, Inc.
November 6, 2018.
45. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and EMSL Analytical, Inc. October 24, 2018.
46. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and Fiberquant Analytical Services. November
5, 2018.
47. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and Forensic Analytical Laboratories, Inc.
October 23, 2018.
48. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and QuanTEM Laboratories. November 13, 2018.
49. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and R. J. Lee Group, Inc. October 24, 2018.
50. EPA, Office of Pollution Prevention and Toxics. Summary of
discussion between EPA and University of Iowa Hygienic Laboratory.
November 1, 2018.
51. HUD, Office of Lead Hazard Control and Healthy Homes. Revised
Dust-Lead Action Levels for Risk Assessment and Clearance. OLHCHH
Policy Guidance 2017-01 Rev 1. February 16, 2017. https://www.hud.gov/sites/documents/LeadDustLevels_rev1.pdf.
52. HUD, Office of Lead Hazard Control and Healthy Homes. Guidelines
for the Evaluation and Control of Lead-Based Paint Hazards in
Housing. Second Edition, July 2012. https://www.hud.gov/program_offices/healthy_homes/lbp/hudguidelines.
53. EPA, Office of Pollution Prevention and Toxics. Definition of
Lead-Based Paint Considerations. June 2019.
54. Cox et al. Improving the Confidence Level in Lead Clearance
Examination Results through Modifications to Dust Sampling
Protocols. Journal of ASTM International, Vol. 8, No. 8. 2011.
55. EPA, Office of Pollution Prevention and Toxics. Revised Final
Report on Characterization of Dust Lead Levels After Renovation,
Repair, and Painting Activities. November 13, 2007. https://www.epa.gov/lead/revised-final-report-characterization-dust-lead-levels-after-renovation-repair-and-painting.
V. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is an economically significant regulatory action that
was submitted to the Office of Management and Budget (OMB) for review
under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563
(76 FR 3821, January 21, 2011). Any changes made in response to OMB
recommendations have been documented in the docket. The Agency prepared
an analysis of the potential costs and benefits associated with this
action, which is available in the docket (Ref. 14).
B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
This action is considered an Executive Order 13771 regulatory
action (82 FR 9339, February 3, 2017). Details on the estimated costs
of this final rule can be found in EPA's analysis of the potential
costs and benefits associated with this action.
C. Paperwork Reduction Act (PRA)
This action does not directly impose an information collection
burden under the PRA, 44 U.S.C. 3501 et seq. Under 24 CFR part 35,
subpart A, and 40 CFR part 745, subpart F, sellers and lessors must
already provide purchasers or
[[Page 32647]]
lessees any available records or reports ``pertaining to'' LBP, LBP
hazards and/or any lead hazard evaluative reports available to the
seller or lessor. Accordingly, a seller or lessor must disclose any
reports showing dust-lead levels, regardless of the value. Thus, this
action would not result in additional disclosures. Because there are no
new information collection requirements to consider under the proposed
rule, or any changes to the existing requirements that might impact
existing information collection request burden estimates, additional
OMB review and approval under the PRA is not necessary.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, the impact of concern
is any significant adverse economic impact on small entities. The small
entities subject to the requirements of this action are small
businesses that are landlords who may incur costs for lead hazard
reduction measures in compliance with the HUD Lead Safe Housing Rule
(LSHR); residential remodelers (who may incur costs associated with
additional cleaning and sealing in houses undergoing rehabilitation
subject to the HUD LSHR); and abatement firms (who may also incur costs
associated with additional cleaning and sealing under the LSHR). The
Agency has determined that approximately 15,000 small businesses would
be subject to this rule, of which 96% have cost impacts less than 1% of
revenues, 4% have impacts between 1% and 3% of revenues, and less than
1% have impacts greater than 3% of revenues. Details of the analysis of
the potential costs and benefits associated with this action are
presented in EPA's Economic Analysis, which is available in the docket
(Ref. 14).
The rule sets health-based hazard standards for dust lead loadings
on floors and window sills. The DLHS do not require the owners of
properties covered by this final rule to evaluate their properties for
the presence of dust-lead hazards, or to take action if dust-lead
hazards are identified. Although these regulations do not compel
specific actions to address identified LBP hazards, these standards are
directly incorporated by reference into certain requirements mandated
by HUD in housing subject to the LSHR. Aside from the HUD regulations,
this rule does not impose new federal requirements on small entities.
EPA's Economic Analysis estimates potential costs for activities in
two types of target housing--those subject to the HUD LSHR and those
where a child with a blood lead level exceeding a federal or state
threshold lives. The analysis presents low and high scenarios for the
number of housing units where a child with a blood lead level exceeding
a federal or state threshold lives. For the low scenario, environmental
investigations are assumed to be conducted when a child's blood lead
level exceeds the threshold set by that child's state. These thresholds
vary from 5 [micro]g/dL to 20 [micro]g/dL, depending on the state. For
the high scenario, environmental investigations are assumed to be
conducted when a child's blood lead level exceeds the CDC's reference
level of 5 [micro]g/dL.
In order to estimate the broader potential impacts of the rule, EPA
assumed that environmental investigations triggered by a child with a
blood lead level exceeding a federal or state threshold include dust
wipe testing of the child's home and that a clean-up occurs whenever
the investigation indicates that dust-lead levels exceed a hazard
standard. As previously indicated, the rule does not require these
actions. Where dust-lead levels are below the standards in the 2001
rule but above the standards in this final rule, the potential clean-up
costs are also included in the economic analysis. The low and high
scenarios for the number of housing units affect the estimated number
of small business that might incur costs for cleaning and additional
dust wipe testing once the hazard standards in this final rule are in
effect. Based on the two scenarios, a total of 22,000 to 48,000 small
businesses are considered in the analysis (this total includes those
firms mentioned above in the discussion of the HUD LSHR). About 7,000
to 33,000 are lessors leasing housing where a child with a blood lead
level exceeding a federal or state threshold resides.
When considering this broader set of firms, EPA's analysis
indicates that nearly 300 landlords that are small businesses may have
cost impacts over 3% under the low scenario, and almost 1,500 may have
such impacts under the high scenario. However, the high scenario makes
a series of assumptions that are likely to overstate costs and impacts.
The high scenario assumes that in all instances where a child's blood
lead level is between the threshold set by that child's state and the
CDC reference value, the dust lead levels are tested in the residence
even when not required; that in all cases where the loadings are above
the hazard standard in a rental unit the landlord takes action, and
incurs costs, to reduce the dust lead levels even when that is not
required. The analysis further assumes that in all those cases the
costs are borne entirely by the landlord (as opposed to being passed
through or recouped in whole or in part through increased rent). As a
result of this series of conservative assumptions, the high scenario
functions as a bounding estimate. A more realistic assessment of the
potential impacts is that they are between the high and low scenarios.
In light of these considerations, even if the broader set of firms were
to be considered, EPA would certify that this action would not have a
significant economic impact on a substantial number of small entities.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The total estimated
annual cost of the proposed rule is $32 million to $117 million per
year (Ref. 14), which does not exceed the inflation-adjusted unfunded
mandate threshold of $156 million.
F. Executive Order 13132: Federalism
This action does not have federalism implications, as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government. States
that have authorized LBP Activities programs must demonstrate that they
have DLHS at least as protective as the standards at 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
new DLHS they can relinquish their authorization. In the absence of a
state authorization, EPA will administer these requirements. Thus,
Executive Order 13132 does not apply to this action.
G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). Tribes that have
authorized LBP Activities programs must demonstrate that they have DLHS
at least as protective as the standards at 40 CFR
[[Page 32648]]
745.227. However, authorized tribes are under no obligation to continue
to administer the LBP Activities program, and if they do not wish to
adopt new DLHS they can relinquish their authorization. In the absence
of a Tribal authorization, EPA will administer these requirements.
Thus, Executive Order 13175 does not apply to this action.
H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is subject to Executive Order 13045 (62 FR 19885, April
23, 1997), because it is economically significant as defined in
Executive Order 12866, and because the environmental health or safety
risk addressed by this action may have a disproportionate effect on
children. (Ref. 18)
The primary purpose of this rule is to reduce exposure to dust-lead
hazards in target housing where children reside and in target housing
or COFs. EPA's analysis indicates that there will be approximately
50,000 to 200,000 children per year affected by the rule (Ref. 14).
I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use
This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy.
J. National Technology Transfer and Advancement Act (NTTAA)
Since this rulemaking does not involve technical standards, NTTAA
section 12(d) (15 U.S.C. 272 note) does not apply to this action.
K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action is not expected to have disproportionately high and
adverse human health or environmental effects on minority populations,
low-income populations and/or indigenous peoples, as specified in
Executive Order 12898 (59 FR 7629, February 16, 1994). The
documentation for this decision is contained in the Economic Analysis,
which is available in the docket (Ref. 14). EPA's Economic Analysis
estimates that the average baseline blood lead levels of children who
are affected by the rule (particularly children in minority and low-
income households) are higher than the nationwide average. The revised
hazard standards would reduce exposure to lead for all residents of
affected housing. Therefore, EPA has determined that the regulatory
options will not have disproportionately high and adverse human health
or environmental effects on any population, including any minority
population or low-income population.
L. Congressional Review Act (CRA)
This action is subject to the CRA, 5 U.S.C. 801 et seq., and the
EPA will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is a ``major
rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 745
Environmental protection, Hazardous substances, Lead poisoning,
Reporting and recordkeeping requirements.
Dated: June 21, 2019.
Andrew R. Wheeler,
Administrator.
Therefore, 40 CFR chapter I, subchapter R, is amended as follows:
PART 745--[AMENDED]
0
1. The authority citation for part 745 continues to read as follows:
Authority: 15 U.S.C. 2605, 2607, 2681-2692 and 42 U.S.C. 4852d.
0
2. In Sec. 745.65, paragraph (b) is revised to read as follows:
Sec. 745.65 Lead-based paint hazards.
* * * * *
(b) Dust-lead hazard. A dust-lead hazard is surface dust in a
residential dwelling or child-occupied facility that contains a mass-
per-area concentration of lead equal to or exceeding 10 [micro]g/ft\2\
on floors or 100 [micro]g/ft\2\ on interior window sills based on wipe
samples.
* * * * *
0
3. In Sec. 745.227, paragraph (h)(3)(i) is revised to read as follows:
Sec. 745.227 Work practice standards for conducting lead-based paint
activities: target housing and child-occupied facilities.
* * * * *
(h) * * *
(3) * * *
(i) In a residential dwelling on floors and interior window sills
when the weighted arithmetic mean lead loading for all single surface
or composite samples of floors and interior window sills are equal to
or greater than 10 [micro]g/ft\2\ for floors and 100 [micro]g/ft\2\ for
interior window sills, respectively;
* * * * *
0
4. In Sec. 745.325, paragraph (e) is revised to read as follows:
Sec. 745.325 Lead-based paint activities: State and Tribal program
requirements.
* * * * *
(e) Revisions to lead-based paint activities program requirements.
When EPA publishes in the Federal Register revisions to the lead-based
paint activities program requirements contained in subpart L of this
part:
(1) A State or Tribe with a lead-based paint activities program
approved before the effective date of the revisions to the lead-based
paint activities program requirements in subpart L of this part must
demonstrate that it meets the requirements of this section in a report
that it submits pursuant to Sec. 745.324(h) but no later than two
years after the effective date of the revisions.
(2) A State or Tribe with an application for approval of a lead-
based paint activities program submitted but not approved before the
effective date of the revisions to the lead-based paint activities
program requirements in subpart L of this part must demonstrate that it
meets the requirements of this section either by amending its
application or in a report that it submits pursuant to Sec. 745.324(h)
but no later than two years after the effective date of the revisions.
(3) A State or Tribe submitting its application for approval of a
lead-based paint activities program on or after the effective date of
the revisions must demonstrate in its application that it meets the
requirements of the new lead-based paint activities program
requirements in subpart L of this part.
[FR Doc. 2019-14024 Filed 7-8-19; 8:45 am]
BILLING CODE 6560-50-P