[Federal Register: January 5, 2001 (Volume 66, Number 4)]
[Rules and Regulations]
[Page 1205-1240]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja01-17]
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Part III
Environmental Protection Agency
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40 CFR Part 745
Lead; Identification of Dangerous Levels of Lead; Final Rule
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 745
[OPPTS-62156H; FRL-6763-5]
RIN 2070-AC63
Lead; Identification of Dangerous Levels of Lead
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is issuing a final regulation under section 403 of the
Toxic Substances Control Act (TSCA), as amended by the Residential
Lead-Based Paint Hazard Reduction Act of 1992, also known as ``Title X
(ten),'' to establish standards for lead-based paint hazards in most
pre-1978 housing and child-occupied facilities. This regulation
supports the implementation of regulations already promulgated, and
others under development, which deal with worker training and
certification, lead hazard disclosure in real estate transactions,
requirements for lead cleanup under State authorities, lead hazard
evaluation and control in Federally-owned housing prior to sale and
housing receiving Federal assistance, and U.S. Department of Housing
and Urban Development (HUD) grants to local jurisdictions to perform
lead hazard control. In addition, today's action also establishes,
under authority of TSCA section 402, residential lead dust cleanup
levels and amendments to dust and soil sampling requirements and, under
authority of TSCA section 404, amendments to State program
authorization requirements. By supporting implementation of the major
provisions of Title X and by providing guidance to all owners and
occupants of pre-1978 housing and child-occupied facilities, this
regulation will help to prevent lead poisoning in children under the
age of 6.
DATES: This final rule is effective on March 6, 2001. This rule shall
be promulgated for purposes of judicial review at 1 p.m. eastern
daylight time on February 5, 2001.
FOR FURTHER INFORMATION CONTACT: For general information contact:
Barbara Cunningham, Director, Office of Program Management and
Evaluation, Office of Pollution Prevention and Toxics (7401),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460; telephone number: 202-554-1404; e-mail address:
TSCA-Hotline@epa.gov.
For technical information contact: Dave Topping, National Program
Chemicals Division (7404), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (202) 260-7737; e-mail address:
topping.dave@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you must comply with other
Title X regulations that are affected by today's action. The following
table identifies potentially affected categories and entities:
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NAICS or
Category Examples of Entities SIC codes Effect of Regulation
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Lead abatement professionals Workers, supervisors, 562910 Provides standards that risk
inspectors, risk assessors, assessors would use to
and project designers identify hazards and
engaged in lead-based paint evaluate clearance tests;
activities. helps determine when
certified professionals
would need to be employed
to perform lead cleanup
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Training providers Firms providing training 611519 Provides standards that
services in lead-based training providers would
paint activities have to teach in their
courses
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Federal agencies that own residential 92511, Standards identify hazards
property 92811 that Federal agencies or
purchasers of Federal
property would have to
abate in pre 1960 housing
prior to sale, under Title
X, section 1013.
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Property owners that receive assistance State and city public 53110, Standards identify hazards
through Federal housing programs housing authorities, owners 531311 that property owners would
of multifamily rental have to abate or reduce as
properties that receive specified by regulations
project-based assistance, issued by HUD under
owners of rental properties authority of Title X,
that lease units under section 1012
HUD's tenant-based
assistance program
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Property owners Owner occupants, rental 531110, Standards identify hazards
property owners, public 531311 that, when known, would
housing authorities, have to be disclosed under
Federal agencies EPA/HUD joint regulations
promulgated under Title X,
section 1018
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This listing is not intended to be exhaustive, but rather provides
a guide for entities likely to be affected by this action. Other types
of entities not listed in the table in this unit could also be
affected. To determine whether you or your business is affected by this
action, you should carefully examine the applicability provisions in
relevant regulations. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed in the FOR FURTHER INFORMATION CONTACT section.
B. How Can I Get Additional Information, Including Copies of this
Document or Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, by
[[Page 1207]]
going directly to the Internet Home Page for this regulation at http://
www.epa.gov/lead/leadhaz.htm and selecting the desired document. You
can also go directly to the Federal Register listings at http://
www.epa.gov/fedrgstr/ to obtain a copy of this final rule.
2. In person. The Agency has established an official record for
this action under docket control number OPPTS-62156. The official
record consists of the documents specifically referenced in this
action, any public comments received during the comment period, and
other information related to this action. This official record includes
the documents that are physically located in the docket, as well as the
documents that are referenced in those documents. The public version of
the official docket, which includes printed, paper versions of any
electronic comments submitted during the comment period, is available
for inspection in the TSCA Nonconfidential Information Center, North
East Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The
Center is open from noon to 4 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Center is (202) 260-7099.
II. Overview
A. Introduction
The Title X term ``lead-based paint hazard'' is intended to
identify lead-based paint and all residential lead-containing dusts and
soils regardless of the source of the lead, which, due to their
condition and location, would result in adverse human health effects.
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 lead-based paint, to the presence of lead-based paint hazards, for
which more substantive action should be undertaken to control
exposures, especially to young children. This regulation establishes
hazard standards for residential lead-based paint, and residential dust
and soil lead. The hazard standards for these three media,
collectively, are statutorily defined as lead-based paint hazards.
B. Summary of Statutory Authority
The Residential Lead-Based Paint Hazard Reduction Act of 1992 was
enacted as Title X of the Housing and Community Development Act of
1992. Title X establishes a comprehensive Federal program for reducing
the risks from lead-based paint and certain lead hazards. The Title X
program primarily gives authority to HUD and EPA, but affects a number
of other Federal agencies. Among other things, Title X amended TSCA by
adding TSCA Title IV, which specifically gives regulatory authority to
EPA to cover, among other things, training of workers who deal with
lead-based paint hazard abatement, the appropriate form of State and
Tribal lead programs, and the identification of dangerous levels of
lead. Title IV includes section 403. EPA is promulgating the standards
for lead-based paint hazards under the authority of TSCA section 403,
15 U.S.C. 2683.
Section 403 requires EPA to promulgate regulations that ``identify
. . . lead-based paint hazards, lead-contaminated dust, and lead-
contaminated soil'' for purposes of the entire Title X. Lead-based
paint hazards, under TSCA section 401 (15 U.S.C. 2681), are defined as
conditions of lead-based paint and lead-contaminated dust and soil that
``would result'' in adverse human health effects (15 U.S.C. 2681(10)).
Lead-based paint is defined by statute as paint with lead levels equal
to or exceeding 1.0 milligrams per square centimeter (mg/
cm2) or 0.5% by weight (see section 302(c) of the Lead-
Poisoning Prevention Act (42 U.S.C. 4822(c)) and TSCA section 401(9)
(15 U.S.C. 2681(9)). 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)). TSCA section 401 defines lead-contaminated soil as
``bare soil on residential real property that contains lead at or in
excess of levels determined to be hazardous to human health'' (15
U.S.C. 2681(12)).
EPA is also promulgating amendments to the regulations for lead-
based paint activities under the authority of TSCA section 402 (15
U.S.C. 2682) and to the State and Tribal program authorization
requirements under authority of TSCA section 404 (15 U.S.C. 2684).
These changes are needed to ensure consistency among the various
regulations covering lead risks under TSCA. Section 402 requires EPA to
promulgate regulations establishing training and certification
requirements for individuals and firms engaged in lead-based paint
activities. Lead-based paint activities, in the case of target housing
and child-occupied facilities, include risk assessment, inspection and
abatement. See TSCA section 402(b)(1); 15 USC 2682(b)(1). To clarify
this definition, EPA notes that lead-based paint activities do not
include interim controls. These regulations ``shall contain standards
for performing lead-based paint activities, taking into account
reliability, effectiveness, and safety'' (15 U.S.C. 2682(a)(1)).
Section 404 requires States and Tribes seeking to administer and
enforce standards, regulations, or other requirements under section
402, 406, or both to seek authorization from EPA.
C. Guiding Principles
Reducing exposure to lead has been an important issue for EPA for
more than 2 decades. Young children are especially vulnerable to the
toxic effects of lead because their nervous systems are still
developing and they absorb more of the lead to which they are exposed.
Many of the health effects associated with lead are thought to be
irreversible. Moreover, the effects at lower levels of exposure are
often asymptomatic. In light of the impacts on children and the nature
of the health effects, EPA's goal is to eliminate exposure to harmful
levels of lead. This goal has informed Agency actions such as the
decision to remove lead as an additive from gasoline as discussed in
the preamble to the proposed rule (63 FR at 30305).
First and foremost, the Agency faces the difficulty of determining
the level at which to set the standards given the uncertainties in
information on cause and effect--what environmental levels in which
specific medium may actually cause particular blood lead levels that
are associated with adverse health effects. The Agency has tools, which
are only generally consistent, that show that certain increases in
environmental lead levels are associated with certain increases in
blood lead levels. Given the range of uncertainty shown in its analysis
supporting the establishment of a hazard level under this rule, EPA has
developed a technical analysis that considers hazard standards for dust
and soil at the lowest levels at which the analysis shows that across-
the-board abatement on a national level could be justified. EPA
recognizes, however that for any levels of lead in dust or soil
judgment must be exercised as to how to treat the medium, and interim
controls as well as abatement could be effective. In addition, EPA
recommends that organizations and individuals consider some form of
interim control in certain residential areas even where soil lead
levels are below the hazard standard if there is a concern that
children under 6 might spend substantial time in such areas, or there
is potential for that soil to contribute to hazardous lead levels in
play areas or dwellings. While the risks from lead at these lower
levels are less than the hazard level, EPA believes that public health
will be further protected if
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owners and occupants of residential properties are encouraged to take
actions to reduce the potential for lead exposure.
In performing its analyses for this rule, the Agency could not
quantitatively compare interim control strategies with abatement
strategies because there are only limited data available on the
effectiveness of interim controls over extended periods of time, and
those data which are available are not suitable for quantitative
comparisons with abatements. In comparing interim control strategies
with abatement strategies, one must make a number of assumptions
concerning the costs of administrative management, and frequency of
monitoring and renewal over the planning horizon. For the 50-year
planning horizon which the Agency used in its dust and soil analyses,
one would have to compare the time stream of interim control expenses,
for as long as such expenses are necessary, and weigh the possible
differences in potential blood-lead reductions, to make a fair
comparison of abatement and interim control strategies.
Nevertheless, experience with interim control programs is
increasing and certain organizations, particularly public health and
housing agencies, believe they have been able to develop effective
programs for interim controls which achieve virtually the same degree
of risk reduction as do abatement programs, but at much reduced cost.
EPA received comments on this issue during the public comment process.
EPA wishes to encourage the continuing evaluation of such efforts
because resources to deal with hazardous lead levels are often limited,
and strategies which achieve comparable risk reduction, but at much
reduced cost, have the potential to protect more children by allocating
the limited resources more effectively. EPA believes that public and
private organizations should evaluate both interim control and
abatement strategies in determining the most effective course of action
when dealing with dust and soil hazards.
In addition, EPA recommends that organizations and individuals
consider some form of interim control response action in certain areas
even where soil lead levels are below the hazard standard. This would
apply if there is a concern that children under the age of 6 spend
substantial time in such areas, or there is potential for that soil to
contribute to hazardous lead levels in play areas or dwellings. While
the risks from lead at these lower levels are less than at the hazard
level, EPA believes that public health will be further protected if
owners and occupants of residential properties are aware of such
contamination and are encouraged to take actions to reduce the
potential for lead exposures.
For determining a paint lead hazard EPA faced a data problem
different from that faced with respect to dust and soil hazards. For
dust and soil, EPA had substantial raw data on environmental levels and
blood lead levels, even though it faced substantial uncertainty in
correlating the levels. For lead-based paint, as discussed later in
this preamble, the Agency had no data by which it could select a
threshold below which the paint would not be a hazard. EPA, therefore,
could not apply the same analysis for the paint hazard determination as
it did for the dust and soil hazard determinations. Comments indicated
that even very tiny amounts of deteriorated lead-based paint are
sufficient in certain circumstances to result in adverse health
effects. Accordingly, EPA has generally designated any amount of
deteriorated paint as a lead-based paint lead hazard. Nevertheless, as
with dust and soil hazards, EPA would not recommend full scale
abatement be undertaken for all paint lead hazards. Instead, the Agency
wishes the public to be aware that any deteriorated lead-based paint
presents enough of a risk that it should be stabilized and carefully
monitored if it is not abated.
Controlling exposure to lead in the residential environment
presents EPA with challenges that, in important respects, are different
from and often more complex than those the Agency deals with in other
regulatory contexts. Among the challenges of this regulation is that it
requires the Agency to address exposure from the past use of products
that contained lead rather than current products and/or processes that
introduce lead into the environment. Assuming that there are safe and
available substitutes, the government can eliminate lead from an
existing product if the risk warrants such removal (e.g., gasoline,
solder for water pipes and food cans). Removing lead that is already in
the environment is far more difficult. It would have been better that
lead never found its way into paint that exists today in approximately
64 million homes. However, since it is so pervasive, EPA is faced with
a number of dilemmas. First, the number of properties that have some
form of lead is enormous. However, the number of buildings with lead
paint an dust that present a hazard is, relatively, much lower. The
Agency must therefore distinguish which of these lead conditions need
to be controlled. Because there is a great deal of variability among
properties containing lead paint, our ability to identify which
properties present risks is limited. Moreover, the exposure risk to
individuals, even if there were not such a large number of affected
properties, can be compounded by child-specific factors (e.g., hand-to-
mouth behavior, pica, nutrition, hygiene).
In addition, the success of the program will largely rely upon the
voluntary participation of States and Tribes, as well as counties and
cities, to implement the program and upon property owners to follow the
standards and EPA's recommendations. If EPA were to set unreasonable
standards (e.g., standards that would recommend removal of all lead
from paint, dust, and soil), States and Tribes may choose to opt out of
the Title X lead program and property owners may choose to ignore EPA's
advice, believing it lacks credibility and practical value.
Consequently, EPA needed to develop standards that would protect
children without wasting resources by chasing risks of negligible
importance and that would be accepted as reasonable by States, Tribes,
local governments, and property owners.
Three other considerations also merit the public's attention.
First, as noted, the standards are designed to focus resources on the
worst problems. If property owners are able to address less pressing
problems (e.g., deteriorated paint below the minimum area threshold),
EPA encourages them to take action. EPA also encourages States, Tribes,
and local governments to adopt more stringent standards if local
circumstances warrant such action.
Second, the standards alone cannot solve the lead problem. They are
part of a broader program designed to educate the public and raise
public awareness, empower and protect consumers, and provide helpful
technical information that professionals can use to identify and
control lead hazards. EPA has developed and implemented an active
public education and outreach program consisting of a toll-free hotline
(1-800-424-LEAD) co-sponsored with HUD and U.S. Centers for Disease
Control and Prevention (CDCP), public service announcements, poster
campaigns, distribution of a parent's guide through grocery stores,
slides in movie theaters, and an outreach campaign with the National
Parent Teachers Association, the National Association of Child Care
Providers, and public libraries.
Consumer empowerment and protection efforts include the hazard
disclosure regulations jointly issued with HUD training and
certification
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standards for individuals and firms engaged in lead-based paint
activities, and the pre-renovation education rule that requires
renovation and remodeling contractors to provide the EPA pamphlet
``Protect Your Family from Lead in Your Home'' to occupants prior to
the start of renovation and remodeling projects. In addition, under
section 402 of TSCA, EPA is currently developing training and
certification requirements for renovation and remodeling contractors
whose activities may create lead hazards.
EPA and other Federal agencies continue to conduct field studies to
identify and evaluate lower cost products and technologies for
evaluating and controlling lead-based paint hazards. The findings of
these studies are distributed to professionals through our lead
hotline, EPA's website (www.epa.gov/lead) and at other agencies'
websites, and through on-going contact with trade and professional
associations. The standards, combined with these other efforts, provide
a comprehensive program designed to reduce and eventually help
eliminate lead in residential paint, dust, and soil as a cause of
childhood lead poisoning.
Third, these standards are based on the best science available to
the Agency. EPA recognizes, however, that the science is constantly
developing and with it our understanding of the relationship between
lead in the environment and human exposure and the relationship between
exposure and health impacts. If new data become available (e.g.,
empirical data showing that very small amounts of deteriorated paint
pose a serious health risk or data showing that hazard control
activities are more effective at reducing long-term dust-lead levels
than assumed by EPA), the Agency will consider changing the standards
to reflect these data. If the data indicate that the standards should
be changed and they meet EPA's quality criteria, the Agency will
consider publishing the data for public review and comment and amending
today's regulation.
D. Regulatory Approach
1. Uniform national standards. EPA is issuing uniform national
standards in this rule. The rationale for adopting uniform national
standards is found on pages 63 FR 30307 to 30308 of the preamble to the
proposed rule. EPA summarizes this reasoning in the following
paragraphs.
EPA stated that the relationship between environmental lead levels
(from paint, dust, and soil) and their effects on the health of exposed
children, which forms the basis for this rule, is complex, and is
dependent upon numerous site-specific and child-specific factors. Where
more site-specific factors can be considered on a smaller (residence or
community) scale, estimates of the effects of environmental levels on
blood lead can be more accurate. The data needed, however, are not
available for communities nationwide. In contrast, national data on
lead in paint, dust, and soil are currently available. Even if data
were available, the residence or community scale standards would still
not account for variability in exposure influenced by child-specific
factors (e.g., hand-to-mouth behavior, hygiene, and nutrition).
Detailed evaluations that considered the specifics of individual
communities would generally require information for each residence to
evaluate the impact of environmental lead on children.
In addition, uniform national standards provide a fixed basis of
comparison for all homes. National standards can be used to compare
properties and establish priorities. This would be extremely difficult
to accomplish if there were the numerous standards specific to
individual communities.
EPA also took into account that certain segments of the population
have a higher incidence of elevated blood-lead levels (e.g., minority
and low-income children). Because estimates of the relationship between
environmental lead levels and children's health effects are not
sufficiently refined to distinguish relationships for particular
subsets of the general population of children, EPA is choosing to
emphasize program implementation (e.g., training, education, and
environmental justice grants), which the Agency considers a more
effective and simpler approach to address vulnerable communities rather
than setting community-specific standards. EPA preferred to establish a
simple, set of standards that could easily be adopted by States,
allowing them to tailor the standards, should they so choose. This
allows States greater flexibility to establish and implement their
programs while a national, baseline level of protection to children is
maintained.
2. Media-specific standards. A second basic issue that shaped EPA's
standard-setting approach involves the fact that a child's total lead
exposure is the sum of contributions from numerous sources, including
paint, dust, soil, and others. Specifically, EPA had to decide whether
to set separate, independent standards for paint, dust, and soil or to
integrate the standards.
Under the first option, EPA would establish a fixed standard for
each medium without considering the varying conditions in the other
media. For example, the soil standard would remain constant, regardless
of whether dust lead levels were high or low. The chief advantage of
this option is that the standards are simple to understand and use.
A potential disadvantage of this approach is that a standard could
be established for a particular medium that does not consider the total
exposure of a child (i.e., exposures from all other media). To address
this potential shortcoming, the Agency considered candidate sets of
standards for dust, lead, and paint together so that its comparisons of
candidate standards reflected exposures to all media. Consequently, the
standards, although they are medium-specific numbers will effectively
identify hazards as long as all media are evaluated and compared to the
standards.
Under the second option, EPA would set standards to account for
total lead exposure from all media. Under a joint standard, the
standard for each medium would vary, depending on the conditions in the
other media. For a graphical [illustration of this option, see page
30308 of the preamble to the proposed rule. The major advantage of the
joint standards is that they avoid anomalous situations. For example,
it stands to reason that if both dust and soil measurements are just
below the hazard levels--35 g/ft2 on the floor and
1,175 parts per million (ppm) in the non-play area--the situation is
more dangerous than if one measurement is above the hazard level--e.g.
1,225 ppm for soil--and floor dust is at zero. Yet the first set of
measurements would not constitute a hazard and the second set would. In
these circumstances, joint standards may better reflect the total
exposure and risk. Furthermore, for this option to be truly effective,
EPA would need to know the levels from all sources of lead exposure and
how they relate to blood lead levels individually and in various
combinations. EPA, currently, lacks the analytical tools to support
selection of joint standards. In addition, EPA is endeavoring to set
the media specific hazard standards low enough that hazardous
situations will not occur if both soil and dust are just below the
standards. In such a case, the media specific standards could be
overinclusive. The Agency, however, believes that this approach is
appropriate to protect public health. Accordingly, in this rule EPA is
establishing media-specific standards. Additional explanation for this
decision
[[Page 1210]]
can be found on pages 30308 and 30309 of the preamble to the proposed
rule.
E. Applicability and Uses of the Standards
The standards established in this rule apply to target housing
(i.e., most pre-1978 housing) and child-occupied facilities (pre-1978
non-residential properties where children under the age of 6 spend a
significant amount of time such as daycare centers and kindergartens).
The standards are intended to be used prospectively. That is, they
should be used to identify properties that present risks to children
before children are harmed. This, of course, would not prevent them
from being used retrospectively in the case of environmental
intervention blood lead investigations and clearance of resulting lead
hazard control activities.
These standards are not appropriate as the sole source of
information to use when identifying the source of exposure for a lead-
poisoned child. When a property is being evaluated in response to an
identification of a lead-poisoned child, the risk assessor in
cooperation with local public health officials should identify and
consider all sources of lead exposure. For example, a risk assessor
should consider lead in drinking water as well as the presence of any
amount of deteriorated lead-based paint.
Within the scope of Title X, these regulatory standards will help
support and implement major provisions of the statute. They will be
incorporated into the risk assessment work practice standards,
providing the basis for risk assessors to determine whether lead-based
paint hazards are present. By helping to determine when a hazard is
present, the standards will help determine when a hazard control
activity must be performed by certified personnel. EPA further notes
that only abatement of lead-based paint hazards specifically hazardous
lead-based paint, dust-lead hazards or soil-lead hazards identified in
40 CFR 745.65 requires certified personnel. This is because
``abatement'' is defined in 40 CFR 745.223 as ``measures designed to
permanently eliminate lead-based paint hazards.'' Thus, permanent
elimination of lead-based paint, and dust or soil lead would not
require the use of certified personnel unless lead-based paint hazards
are present in those media.
States and Tribes wishing to obtain or retain authorization to
administer and enforce training and certification programs must
incorporate hazard standards as protective as the standards in this
rule. Provisions for State and Tribal authorization are described at 40
CFR part 745, subpart Q. These standards will also help property owners
comply with section 1018 by establishing what conditions must be
disclosed to prospective purchasers and renters as lead-based paint
hazards prior to the sale or rental of target housing. HUD, the
Department of Defense (DoD), and other Federal agencies will use these
standards in implementing or overseeing the evaluation and control of
hazards in Federally-assisted housing and Federally-owned housing prior
to disposition. (24 CFR part 35)
Under section 1018 of Title X (42 U.S.C. 4852d), EPA and HUD have
jointly developed regulations requiring a seller or lessor of most pre-
1978 housing to disclose the presence of any known lead-based paint and
lead-based paint hazards to the purchaser or lessee (24 CFR part 35,
subpart A; 40 CFR part 745, subpart F). When these section 403 rules
become effective, lead-based paint hazards in lead paint, dust or soil
will need to be disclosed. EPA further notes, however, that under the
section 1018 rules, the seller or lessor also must provide the
purchaser or lessee any available records or reports ``pertaining to''
lead-based paint, lead-based paint hazards and/or any lead hazard
evaluative reports available to the sellor or lessor (section
1018(a)(1)(B). See 40 CFR 745.107(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 hazards. 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 lead-based paint
free by a certified inspector (24 CFR 35.82; 40 CFR 745.101), although
voluntary disclosure of such certifications is encouraged.
Beyond the scope of Title X, these standards will guide the control
of lead-based paint hazards in the nation's housing stock.
Although other regulations (e.g., hazard evaluation and control in
housing receiving Federal assistance and Federally-owned housing prior
to sale) may require property owners to evaluate properties for the
presence and/or control of lead hazards, today's action does not
contain such requirements. Specific requirements are determined by the
particular State, Federal, and local government regulations which
mandate actions when health hazards are found in target housing or
child-occupied facilities. EPA, however, strongly recommends that
property owners or other decision makers take appropriate actions to
reduce or eliminate hazards. Finally, the standards provide property
owners and other decision makers with the Federal government's best
judgement concerning lead dangers in residential paint, dust, and soil.
The standards were established assuming that property owners and
other decision makers would identify and control hazards in all three
media (i.e., paint, dust, and soil). Failure to take a multimedia
approach may not provide adequate protection to children. First, the
protectiveness of the standards assumes that all media will be
appropriately addressed. Second, failure to address one or more medium
leaves children at risk from exposure to lead in media that are not
addressed. Third, failure to address one or more media reduces the
effectiveness of hazard control actions that are taken due to
recontamination of one media from lead in another. Fourth, the Agency
believes that soil can be a source of exposure whenever it is
accessible for either incidental ingestion or tracking into a home, and
that while grass and other coverings may be effective in significantly
reducing potential exposures, such coverings must be maintained in
order to provide continuing protection.
F. Summary of the Final Rule
1. Hazardous lead-based paint (Sec. 745.65(a)). The hazard standard
for lead-based paint, called the ``paint lead hazard,'' is any of the
following:
a. Any lead-based paint on a friction surface that is subject to
abrasion and where the lead dust levels on the nearest horizontal
surface underneath the friction surface are equal to or greater than
the dust hazard levels.
b. Any damaged or otherwise deteriorated lead-based paint on an
impact surface that is caused by impact from a related building
component.
c. Any chewable lead-based paint surface on which there is evidence
of teeth marks.
d. Any other deteriorated lead-based paint in residential buildings
or child-occupied facility or on the exterior of any residential
building or child-occupied facility.
The purpose of identifying almost all deteriorated lead-based paint
as a paint lead hazard is to alert the public to the fact that all
deteriorated lead-based paint should be addressed--through use of paint
stabilization or interim controls. Something less than abatement and
certified personnel, however, would be needed to undertake interim
controls or to abate lower levels of deterioration.
[[Page 1211]]
Two existing HUD and EPA rules provide the applicable standards: HUD
rules under sections 1012 and 1013 of Title X published on September
15, 1999 (61 FR 50140), and EPA work practice rules under section 402
of TSCA published on August 29, 1996 (61 FR 45778) (FRL-5389-9). In
general, these rules provide that occupant protection procedures,
clearance testing, use of certified personnel or other similar
specialized lead hazard control practices and procedures are not
required if one or more of the following conditions exist:
a. Two square feet or less of deteriorated lead-based paint in a
room.
b. Twenty square feet or less of deteriorated exterior lead-based
paint;
c. Ten percent of the total surface area on an interior or exterior
type of component with a small surface area consist of deteriorated
lead-based paint.
2. Dust standards. Today's regulation includes two standardsfor
dust: hazard levels for floors (including carpeted floors) and interior
window sills (Sec. 745.65(b)) and clearance standards for floors
(including carpeted floors), interior window sills, and window troughs
(Sec. 745.227(e)(8)(viii)). The dust-lead hazard standards are 40
g/ft2 for floors based on a weighted average of all
wipe samples and 250 g/ft2 for interior window
sills based on a weighted average of all wipe samples. The weighted
average, or weighted arithmetic mean, means the arithmetic mean of
sample results weighted by the number of subsamples in each sample. Its
purpose is to give influence to a sample relative to the surface area
it represents.
The clearance standards for dust following an abatement are 40
g/ft2 for floors, 250 g/ft2 for
interior window sills, and 400 g/ft2 for window
troughs. The dust-lead level must be less than the applicable standard
for the surface to pass clearance. Clearance standards are used to
evaluate the effectiveness of cleaning following an abatement, and EPA
may also use these standards in future rulemakings to evaluate the
effectiveness of cleaning following a renovation and remodeling
project. Properties that undergo abatement must pass clearance
according to the work practice standards for abatement found at 40 CFR
745.227. If a property fails clearance, it must be recleaned until it
passes, although it is not automatically necessary to reclean the
entire property when clearance fails, such as when some of the visual
and dust-testing clearance results have indicated that portions of the
property are already cleared.
3. Soil standards. Today's regulation establishes the following
standards for bare residential soil: a hazard standard of 400 ppm by
weight in play areas based on the play area bare soil sample and an
average of 1,200 ppm in bare soil in the remainder of the yard.based on
an average of all other samples collected. See Sec. 745.65(c). The
final rule also identifies lead-contaminated soil as soil with levels
equal to or greater than these soil-lead hazard standards.
Property owners and other decision makers should implement
effective measures to reduce or prevent childrens' exposure to lead in
soil that exceeds these levels. These measures may incorporate, but are
not limited to, interim controls that include covering bare soil and
placement of washable doormats in entryways. The need for more
permanent controls should be determined with consideration of local
conditions and usage patterns, the relative risks from different lead
sources, and the potential for exposures to change over time.
4. Summary of other actions. Today's rule also amends existing
regulations for lead-based paint activities including:
a. Requirements for interpreting the results of a lead-based paint
risk assessment sampling for purposes of determining if lead-based
paint hazards are present.
b. Changes to the risk assessment work practice standards at 40 CFR
745.227 to require testing of all deteriorated paint on surfaces with a
distinct painting history to determine if the paint is lead-based.
c. Changes to the dust and soil sampling locations in the risk
assessment work practice standards at 40 CFR 745.227.
d. Work practice standards for the management of soil removed
during an abatement.
e. Amendments to the State and Tribal program authorization
requirements under 40 CFR part 745, subpart Q; and
f. Amendment to the definition of ``abatement'' at 40 CFR 745.223
to make it clear that abatement does not include removal of paint,
dust, and soil unless lead-based paint hazards are present in those
media.
G. Limitations of the Hazard Standards
As stated in the proposed rule (63 FR at 30304), there is
significant confusion about the requirements and purpose of the TSCA
section 403 regulations. Consequently, EPA felt it necessary in the
preamble to the proposed rule to highlight major limitations and other
issues related to the scope and use of the regulation. These statements
continue to apply. To summarize, the regulation does not establish a
new definition for lead-based paint. The hazard standards apply to
conditions observed when the risk assessment was performed. The
standards do not address the potential for a hazard to develop. The
standards apply to target housing, but may be used as guidance for
other residential property. Finally, the standards are intended to
identify dangerous levels of lead, not housing that is free from risks
associated with exposure to lead.
As stated in Unit II.F.3., today's rule establishes two hazard
standards for bare residential soil; 400 ppm for play areas and an
average of 1,200 ppm for the rest of the yard. EPA recommends that
organizations and individuals consider some action in certain areas
even where levels in bare soils are below the hazard standard,
particularly, if there is a concern that children 6 years and under
might spend substantial time in such areas, or if there is concern that
the bare soil in such areas may contribute to lead levels in the
dwelling, or in the play areas. However, this rule does not mandate
that any action be implemented when levels are found to be below the
lead hazard standard. Moreover, the kind of response that organizations
and individuals might consider could include modest actions such as
planting grass (or other ground cover) to more extensive actions such
as covering the bare soil with several inches of clean fill.
As indicated in Unit II.E., it is also important to emphasize that
this rule only applies to pre-1978 target housing and certain child-
occupied facilities, and that these standards were not intended to
identify potential hazards in other settings. If one chooses to apply
the hazard level 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. See also Unit IV.D. for a discussion regarding the
relationship of the soil hazard standard to Superfund soil cleanup
standards.
H. Preamble Overview
The remainder of this preamble consists of four units. Unit III.
presents an explanation of the Agency's decisions. It includes a
summary of the proposal, identifies the major changes between the
proposed and final rules, and explains the changes. Unit IV. presents a
discussion of some of the more significant issues raised by the public
comments. Unit V. contains the
[[Page 1212]]
references for sources used in this preamble. Unit VI. is the
regulatory assessment unit, which deals with the Federal requirements
for agency rulemaking that are imposed by various statutes and
executive orders. Unit VII. discusses the Congressional Review Act
requirements.
III. Explanation of the Agency's Decisions
A. Summary of the Proposed Regulation
EPA published the proposed regulations on June 3, 1998 (63 FR
30302) (FRL-5791-9). The proposed standard for hazardous lead-based
paint was lead-based paint in poor condition, defined as more than 10
ft2 of deteriorated lead-based paint on exterior components
with large surface areas, more than 2 ft2 of deteriorated
lead-based paint on interior components with large surface areas, or
deteriorated lead based paint on more than 10% of the total surface
area of interior or exterior components with small surface areas.
Lesser amounts of deteriorated paint were considered de minimis levels
and were not considered hazards. The proposed standard for a dust lead
hazard was the average level of lead in dust that equals or exceeds 50
g/ft2 on uncarpeted floors and 250 g/
ft2 on interior windows sills. The proposed standard for
soil-lead hazard was lead that equals or exceeds 2,000 ppm based on a
yard-wide average soil-lead concentration. A soil-lead level of
concern, proposed to be 400 ppm, was included in draft guidance but not
in the proposed regulation. The statutory basis for the level of
concern was the section 403 requirement that EPA identify ``lead-
contaminated soil,'' which the Agency interpreted to be a level less
than the soil-lead hazard. EPA used the term ``level of concern''
instead of ``lead-contaminated soil. EPA proposed that lead-based paint
hazards be identified by certified risk assessors performing risk
assessments according to the work practice standards at 40 CFR 745.227.
The June 3, 1998 document also proposed amendments to existing
regulations for lead-based paint activities including:
1. Clearance standards for dust following an abatement of 50
g/ft2 for uncarpeted floors, 250 g/
ft2 for interior window sills, and 800 g/
ft2 for window troughs.
2. Requirements for interpreting the results of a lead-based paint
risk assessment sampling for purposes of determining if lead-based
paint hazards are present.
3. Changes to the dust and soil sampling locations in the risk
assessment work practice standards at 40 CFR 745.227.
4. Work practice standards for the management of soil removed
during an abatement; and
5. Amendments to the State and Tribal program authorization
requirements under 40 CFR part 745, subpart Q.
B. Summary of Significant Changes from the Proposed Regulation and
Other Major Decisions
This section of the preamble briefly presents the major changes
between the proposal and final rule. EPA also identifies major
provisions of the proposed regulation that remain unchanged in the
final rule. Unit II.D. of the preamble presents the Agency's
explanation for these decisions.
1. Dust standards. The final rule changes the lead-based paint
hazard standard for dust, known as the dust-lead hazard, and the
standard for dust clearance for floors to 40 g/ft2.
In addition, the dust-lead hazard will apply to all floors, including
carpeted floors. It will not be limited to bare floors. The final rule
does not change the dust-lead hazard for interior window sills. Today's
action lowers the clearance level for window troughs from the proposed
800 g/ft2 to 400 g/ft2. In
addition, the final rule modifies the method for interpreting composite
dust clearance samples. Under the proposed rule, the result of the
composite sample would have been compared to the clearance level
divided by the number of subsamples in the composite. The final rule
requires the result of the composite sample to be compared to the
clearance level divided by half the number of subsamples in the
composite.
2. Soil standards. With respect to the soil standards, there are
several changes from the proposed rule. First, EPA is not establishing
any distinction between lead-contaminated soil (soil lead ``level of
concern'') and soil-lead hazards. Instead, EPA is, in the preamble,
simply identifying lead-contaminated soil as soil with levels equal to
or greater than the soil-lead hazard standards. For purposes of this
rule ``lead-contaminated soil'' is the same as a ``lead-based paint
hazard'' based on soil lead.''
Second, in the final rule EPA is establishing the lead-based paint
hazard standard for bare soil, known as the soil-lead hazard standard,
to have one hazard level for play areas and another for the remainder
of the yard. The proposed rule did not give special attention to play
areas and made the hazard determination based on the whole yard only.
From the proposed 2,000 ppm for bare soil in the entire yard, EPA is
setting a final soil-lead hazard of 400 ppm for bare soil in play areas
and an average of 1,200 ppm for bare soil in the non-play area portion
of the yard.
3. Paint standards. The paint component of the lead-based paint
hazard standards is known as the paint-lead hazard. The paint-lead
hazard consists of three standards: Deteriorated lead-based paint;
lead-based paint on friction and impact surfaces; and lead-based paint
on accessible (chewable) surfaces.
a. Deteriorated paint. EPA considers that, in general, any
deteriorated lead-based paint needs to be addressed and should be
considered a paint-lead hazard. Accordingly, in the final rule the
Agency does not have a de minimis level of deteriorated paint for the
paint-lead hazard. Instead, the final rule simply refers to work
practice and certification regulations issued by HUD and EPA that apply
to dealing with paint-lead hazards. These regulations provide that
occupant protection procedures, clearance testing, use of certified
personnel or other similar specialized lead hazard control practices
and procedures are not required at lesser levels of paint
deterioration. These specific levels of deterioration are (i) Two
square feet or less of deteriorated lead-based paint per room; (ii)
twenty square feet or less of deteriorated exterior lead-based paint;
(iii) ten percent of the total surface area on an interior or exterior
type of component with a small surface area.
b. Friction and impact surfaces. The standard in the final rule for
the paint-lead hazard on friction surfaces is lead-based paint that is
subject to abrasion where the lead dust levels on the nearest
horizontal surface underneath the friction surface are equal to or
greater than the lead-dust hazard levels. The paint-lead hazard for
impact surfaces is any damaged or otherwise deteriorated paint on an
impact surface that is cause by impact from a related building
component. No minimum area threshold of paint deterioration applies to
friction or impact surfaces. In the proposed rule, EPA did not include
a preferred option for these surfaces. The Agency, instead, solicited
public comment on a range of options including: Lead-based paint
regardless of condition on a friction/impact surface; abraded lead-
based paint on a friction/impact surface; and no separate standard.
c. Surfaces accessible for chewing or mouthing. The standard for
the paint-
[[Page 1213]]
lead hazard on accessible surfaces, referred to as ``chewable''
surfaces in the final rule, is any chewable lead-based paint surface on
which there is evidence of teeth marks. No minimum area threshold
applies to deteriorated lead-based paint on accessible surfaces. In the
proposed rule, EPA did not include a preferred option for these
surfaces. The Agency, instead, solicited public comment on a range of
options including: Lead-based paint regardless of condition on interior
window sills up to 5 feet off the floor; and no separate standard for
accessible surfaces. EPA has eliminated the 5-foot requirement.
4. Requiring certified risk assessors to determine the existence of
lead-based paint hazards. The final rule does not include a requirement
that the presence of lead-based paint hazards must be determined by
certified risk assessors following the risk assessment work practice
standards at 40 CFR 745.227.
C. Explanation of the Agency's Decisions
In this section of the preamble, EPA provides its reasons for
choosing the final TSCA section 403 standards for lead-based paint
hazards (which includes paint-lead, dust-lead, and soil-lead hazards)
and its final determination for what constitutes lead-contaminated dust
and residential soil. In addition, EPA provides its reasons for
establishing the clearance levels for household dust--measures of dust
in lead that will show that hazards have been appropriately cleaned.
The choice of the particular methodologies used to develop each of
these standards constitutes another important set of decisions. Hazard
levels for dust and soil were developed using an analysis of risk, the
potential for risk reduction (considering uncertainties in the data and
scientific evidence describing the risks), and the cost of reducing
risk. In determining the paint-lead hazard, EPA has decided that any
deteriorated lead-based paint would result in adverse health effects,
based on information submitted in public comments and other information
in the rulemaking record. The Agency has been unable to determine any
level of deteriorated lead-based paint that should not be considered a
paint-lead hazard.
The general outline of these methodologies is referred to in later
sections of this Unit and, where applicable, incorporates into the
final rule those decisions made in the preamble to the proposed rule.
1. Basis for dust and soil standards. As a preliminary matter, EPA
has found, after considering all significant public comments and all
other information in the rulemaking record, that the legal
interpretations and policy decisions in the preamble to the proposed
rule form the basis for the final decisions discussed in this preamble,
except as indicated below. EPA hereby incorporates, for purposes of
this final rule, the relevant reasoning and analyses from the proposed
preamble, as indicated below. Any modifications to the analyses or
reasoning from the preamble to the proposed rule will be specifically
explained in this preamble, the Reponse to Comment (RTC) document, or
other documents in the record, and are supported by the record for the
final rule.
a. Legal basis. Details of the basic legal structure of Title X and
the legal effect of the issuance of regulations under TSCA section 403,
including the responsibilities of EPA and HUD, are set forth in the
preamble to the proposed rule (63 FR 30306) and need not be repeated
here. There EPA provided a detailed discussion of its views at the time
of the statutory mandate and the statutory criteria, including the
Agency's interpretation of relevant terms and the statutory basis for
the Agency's decision to use particular criteria to develop the
determination for what constitutes lead-contaminated dust and lead-
contaminated soil and the hazard standards for dust, soil and paint at
(63 FR at 30311-30315). EPA has modified some of these interpretations
and retains others, as discussed below.
EPA needs to define three terms under TSCA section 403, ``lead-
based paint hazards,'' ``lead-contaminated dust'' and ``lead-
contaminated soil.'' Lead-based paint hazards consist of lead-
contaminated paint, lead-contaminated dust and lead-contaminated soil
that ``would result'' in adverse health effects.
Section 401(9) of TSCA provides a definition of lead-based paint,
which EPA interprets to be lead-contaminated paint for purposes of this
rule. EPA noted that lead-based paint is not, under the statute, a
risk-based term, but only a benchmark that identifies material subject
to jurisdiction of the authorities of TSCA and Title X. Not all lead-
based paint is a hazard, only that paint which EPA determines ``would
result'' in adverse health effects. EPA has determined, as discussed
below, that the dust and soil levels designated as lead-based paint
hazards are also identified as ``lead-contaminated dust'' and ``lead-
contaminated soil.'' This equating of dust and soil contamination with
``lead-based paint hazards'' caused by dust and soil lead represents a
change from the reasoning in the preamble to the proposed rule. EPA's
reasons for this change are discussed below.
EPA generally refers to the hazards in each of the media as
``paint-lead hazards,'' ``dust-lead hazards'' and ``soil-lead
hazards.''
i. Decision on contaminated dust and soil. While section 403
obligates the Agency to identify lead-based paint hazards, lead
contaminated dust, and lead-contaminated soil, the legislative history
and statutory text are themselves silent on how Congress intended the
Agency to differentiate between the standard for soil contamination
(the level of lead in soil determined to be hazardous to human health),
dust contamination (the level of lead in dust that poses a threat of
adverse health effects in pregnant women or young children), and the
levels of contaminated dust or soil that constitute a lead-based paint
hazard (a condition that would result in adverse human health effects).
Further, the terms ``lead-contaminated dust'' and ``lead-contaminated
soil'' have no significance under either TSCA or Title X except insofar
as the level of contaminated dust or soil constitutes a ``lead-based
paint hazard''.
In the proposed rule EPA considered that, because the statute
required the identification of ``lead contaminated'' dust and soil, the
Agency needed to establish separate levels for these terms than for
``lead-based paint hazards'' resulting from contaminated dust or soil.
Furthermore, EPA proposed, based on the statutory language and the
structure of the statute, that the determination of whether dust or
soil were contaminated required less certainty than whether such dust
or soil constituted a hazard. See 63 FR 30311-12. In the preamble to
the proposed rule EPA set the ``contamination'' levels, then called
``levels of concern,'' at those levels the Agency determined could
result in a 1 to 5% probability of an individual child's exceeding a
blood lead level of 10 g/dL. See 63 FR 30316-30317.
EPA noted, however, that the terms, ``lead-contaminated'' dust and
soil have no direct effect on any activities subject to regulation
under Title X. For example, no certification requirements are imposed
for persons who remove lead-contaminated soil, only for those who
remove soil associated with soil-lead hazards. Because the
contamination levels do not affect other activities under Title X or
TSCA Title IV, EPA proposed not to include them in the regulatory
language. EPA only proposed to adopt in guidance to accompany the final
rule a separate level for lead-contaminated soil of 400
[[Page 1214]]
ppm for the entire yard. EPA did not propose to adopt a separate
standard for contaminated dust, since it found substantial overlap in
its analysis and could not distinguish between dust-lead contamination
and dust-lead hazards.
EPA received a significant number of comments criticizing the
establishment of these ``contamination'' levels, particularly for soil,
primarily because setting two levels for ``contamination'' and
``hazard'' would confuse the public. Other comments claimed EPA had no
authority to establish separate contamination levels, as opposed to
hazard levels.
While the Agency clearly has authority to establish separate levels
for contaminated dust and soil, given the comments, the lack of clear
statutory direction, and the lack of significance of the terms in the
statutory structure, the Agency has determined not to establish any
separate levels for contaminated dust or soil beyond those levels that
constitute a lead-based paint hazard. The Agency believes it sufficient
for purposes of TSCA and Title X to conclude that, at a minimum, the
quantity of lead in dust or soil found to result in conditions that
cause exposure to lead that would result in adverse human health
effects (i.e., constitutes a lead-based paint hazard) is ``lead-
contaminated dust'' and ``lead-contaminated soil,'' respectively.
Accordingly, for purposes of this regulation, the dust and soil levels
designated as lead-based paint hazards are also identified as ``lead-
contaminated dust'' and ``lead-contaminated soil''.
ii. Weight of evidence for dust and soil hazard standards. EPA's
dilemma in determining what constitutes dust-lead and soil-lead hazards
is based on the Agency's recognition that any determination of hazard
requires a great deal of judgment in the case of lead health risks
where, ``as a practical matter, all the scientific evidence is
uncertain to some degree . . .'' (See preamble to the proposed rule at
63 FR 30313.) Making judgments on the science varies to a large extent
with respect to three issues: How to determine which blood lead levels
are truly hazardous; how to interpret the statutory language ``result
in adverse human health effects,'' when uncertainties exist; and how
best to account for uncertainties in the risk analyses that relate
environmental lead levels to blood lead levels and the prevalence data
that is used in this analysis.
The resolution of these issues, at best, produces a continuum
where, at one end, blood and environmental levels exist that everyone
would agree constitute a hazard. At the other end, approaching blood
lead levels in the general population (averaging lower than 5
g/dL) or typical environmental levels (generally, less than
the hazard levels found in this regulation), greater uncertainty exists
on how to model the likelihood of health effects. This is compounded by
having to factor in uncertainties of the effects of both blood lead
levels and the associated environmental levels. This is because, even
if EPA has confidence in the blood lead levels of concern, the Agency
still faces the uncertainty of associating blood lead with
environmental levels in each medium, as well as possible effects from
other sources--for example, water and air emissions.
In addressing the first issue, the Agency has chosen 10 g/
dL as the blood-lead level of concern. This value is equal to the level
of concern recommended by the CDCP and the Agency's reasons for
choosing this value are explained in the next section of this preamble.
As to the second issue, 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
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.
The Agency therefore elected to take a pragmatic approach to
setting the hazard standards namely, evaluating the amount of risk
reduction that the hazard standards could provide. That is, rather than
trying to select standards based solely on model-based probability
distributions (which is even further complicated by the fact that
different models produce different results), the Agency looked at the
consequences of the standards based on the assumption that, if EPA
calls something a ``lead-based paint hazard,'' all persons would act
rationally in their own best interests and would permanently eliminate
(abate) these hazards before a child is about to become exposed to
them. This is the so-called ``normative'' analysis referred to in the
preambles to the proposed and final rule and discussed in detail in the
economic analyses and preambles for the proposed and final rules.
(EPA's analysis for using this method for determining what constitutes
dust and soil hazards is discussed in detail in the preamble to the
proposed rule at 30312-15. That analysis is incorporated as the final
interpretation of the Agency on this matter and will not be repeated in
great detail here. Later in this preamble, EPA responds to the various
public comments on its analysis of the appropriate method for
determining dust and soil lead-hazards under TSCA section 403.)
Also, identification of lead-based paint hazards under this
regulation is sure to have impacts that could be expensive even though
the range of expenses is, itself, difficult to resolve because of the
uncertainty of individual behavior and the willingness of individuals
to accept risks that EPA may identify. Thus, if EPA were to choose
standards that are too low, the public could be unable to distinguish
between trivial risks at the low levels of lead from the more serious
risks at higher levels. This could result in clean up for little to no
health benefit, or conversely, it could result in almost no clean up
because persons would question the credibility of the ``hazard''
determination. Thus, they may ignore even those high risk situations
that need to be controlled. On the other hand, if the Agency chooses
standards that are too high, actual adverse effects could occur at
levels below that. EPA's dilemma is to draw this line.
Based on the language of section 403, the purposes of Title X and
its legislative history, and basic policy decisions, EPA determined
that it was a reasonable exercise of its discretion to draw this line
based on consideration of the potential for risk reduction of any
action taken (considering uncertainties in the data and the scientific
evidence describing the risks) and whether such risk reductions are
commensurate with the costs of those actions. This is commonly referred
to as cost-benefit balancing. In this rule, EPA used cost-benefit
balancing to assist in identifying the hazard standards. This method
was useful because available data run through various models showed a
range of environmental levels that could be associated with a
particular blood-lead level (the surrogate used to approximate risk)
and the potential reduction in blood-lead concentration/risk that could
result from eliminating or controlling the environmental level. Given
this range, EPA used cost-benefit balancing to assist in selecting the
specific
[[Page 1215]]
standards for this rule from within the range bounded by the results of
the models.
Using this approach, the Agency is better able to deal with the
third issue identified above how to best consider and account for the
strengths and weaknesses of its risk assessment tools and data. For
example, in estimating the number of homes that would be identified as
hazards at various environmental lead levels, the Agency relied upon
data from the HUD National Survey. Obviously, when assessing the
impacts of standards at lower environmental lead levels, estimates are
more likely to be inaccurate due to the presence of outliers in the
data than would be the case in the middle range of the data.
Additionally, the Agency must consider the range of exposures over
which its models relating environmental lead to blood lead can be
expected to perform well and the sensitivity of those models to the
data inputs. By considering at which points in its analyses the data
and models are strongest and weakest, the Agency can identify where in
its analyses the greatest levels of certainty exist. Consideration of
these factors is described in section 3.b., which discusses the
selection of the dust and soil hazard levels.
b. Choosing the lowest candidate hazard standards. While EPA is no
longer considering the determination of what constitutes lead-
contaminated dust or soil to be governed by different standards from
those used in the determination of what constitutes dust or soil-lead
hazards, the analysis used in the proposal to determine the
contamination standards is still relevant to the consideration of
options for the hazard standards. This is because the effect of
choosing the proposed dust and soil lead contamination standards based
on a 1 to 5% probability of an individual child's having blood lead
levels exceeding 10 g/dL was to establish the lowest candidate
hazard standards. In the proposal, this was for dust 50 g/
ft2 on uncarpeted floors and 250 g/ft2
for sills and for soil 400 ppm in the entire residential yard.
Additional analysis, as noted below in discussion of the dust and soil
hazard level determination, was applied to actually develop the hazard
standards.
Furthermore, as noted above, the determination of which blood lead
levels are truly hazardous (the blood lead level of concern) was the
first scientific issue EPA had to decide in selecting dust and soil
lead hazards.
Accordingly, EPA adopts as the basis determining the lowest
candidate standards for the final dust and soil lead hazards the same
policy basis used in the proposal for choosing dust and soil lead
contamination levels--a 1 to 5% probability of a child's developing a
blood lead level of 10 g/dL.
The choice of 10 g/dL is based on a significant body of
scientific evidence, extensively cited in the preamble to the proposed
rule, that shows that a number of significant health effects manifest
themselves in the 10-15 g/dL range. EPA hereby incorporates as
the basis for its final decision on the blood lead concentration of
concern all relevant discussions in the preamble to the proposed rule,
particularly the discussion at 63 FR 30316-17. The Agency's decision is
supported by past statements made by the Clean Air Science Advisory
Committee and is consistent with Federal policy established by the CDCP
and the recommendations of the National Academy of Sciences (NAS). The
Agency wishes to emphasize, as it stated in the proposed rule, that
this choice does not imply that 10 g/dL is a threshold level.
On the contrary, EPA maintains its position that there is no known
threshold for lead. EPA decided not to use a level lower than 10
g/dL because the evidence indicates that health effects at
lower levels of exposure are less well substantiated, based on a
limited number of children, and observation of subtle molecular changes
that are not currently thought to be sufficiently significant to
warrant national concern.
The choice of probability is based on the Agency's interpretation
of the statute and the limits of EPA's analytical tools. The Agency
rejected the lowest possible probability, which is zero. Even without
lead-based paint and lead-contaminated soil and dust, there could be
some small mathematical probability that a child could still have a
blood-lead level equaling or exceeding 10 g/dL. This is
because other sources of exposure (e.g., air, water, diet, and
background levels of lead) remain. Because under the statute EPA may
only account for risks associated with paint, dust and soil, a zero
exceedence probability would not make sense for this rule.
In addition, EPA's assessment for this rule indicates that, as a
practical matter, in the context of establishing on a national level
the initial candidate for the hazard level, the probabilities that
given environmental levels of lead ``would result'' in blood lead
levels of concern, 1% is not distinguishable from 5% in estimating
risks from soil lead. This is because, within the context of the
analyses for this rule, there was substantial overlap in estimates of
risk from soil lead within the 1 to 5% risk range. This overlap is due
to the uncertainty and variability related to EPA's analyses to
associate low levels of lead in a specific environmental medium to
blood-lead concentrations and limited data. For example, results from
models used to relate environmental levels to blood lead levels vary
depending upon what is assumed about the interrelationship between dust
and