[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

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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

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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