30302 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 745

[OPPTS–62156; FRL–5791–9]

RIN 2070–AC63

Lead; Identification of Dangerous

Levels of Lead

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of proposed rulemaking.

SUMMARY: In accordance with 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,’’ EPA

is proposing a regulation to establish

standards for lead-based paint hazards

in most pre-1978 housing and childoccupied facilities. This proposed

regulation is a focal point of the Federal

lead program and 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 and

Federally-assisted housing, and U.S.

Department of Housing and Urban

Development (HUD) grants to assist in

lead hazard abatement. In addition,

today’s action also proposes, under the

authority of TSCA section 402,

residential lead dust cleanup levels and

amendments to dust and soil sampling

requirements and, under the authority

of TSCA section 404, amendments to

State program authorization

requirements. By supporting the

implementation of the national lead

program, this proposed regulation

would help to prevent lead poisoning in

children under the age of 6.

DATES: Written comments in response to

this proposed rule must be received on

or before September 1, 1998.

ADDRESSES: Each comment must bear

the docket control number OPPTS–

62156. All comments should be sent in

triplicate to: OPPT Document Control

Officer (7407), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 401 M St., SW., Rm.

G099, East Tower, Washington, DC

20460.

Comments and data may also be

submitted electronically to:

oppt.ncic@epamail.epa.gov. Follow the

instructions under Unit X. of this

document. No Confidential Business

Information (CBI) should be submitted

through e-mail.

All comments which contain

information claimed as CBI must be

clearly marked as such. Three copies,

sanitized of any comments containing

information claimed as CBI, must also

be submitted and will be placed in the

public record for this rulemaking.

Persons submitting information, any

portion of which they believe is entitled

to treatment as CBI by EPA, must assert

a business confidentiality claim in

accordance with 40 CFR 2.203(b) for

each such portion. This claim must be

made at the time that the information is

submitted to EPA. If a submitter does

not assert a confidentiality claim at the

time of submission, EPA will consider

this as a waiver of any confidentiality

claim and the information may be made

available to the public by EPA without

further notice to the submitter.

If requested, EPA will schedule public

meetings where oral comments will be

heard. EPA will announce in the

Federal Register the time and place of

any public meetings. Oral statements

will be scheduled on a first come first

served basis by calling the telephone

number listed in the Federal Register

notice that announces these meetings.

All statements will be made part of the

public record and will be considered in

the development of the final rule.

FOR FURTHER INFORMATION CONTACT: For

general information contact: National

Lead Information Center’s

Clearinghouse, 1-800-424-LEAD(5323).

For specific technical and policy

questions contact: Jonathan Jacobson,

(202) 260-3779;

jacobson.jonathan@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. Overview

This overview identifies entities

potentially affected by the rule,

summarizes the proposed rule,

describes the uses and key limitations of

the proposal’s scope, and provides a

roadmap of the preamble.

A. Regulated Entities

The following table identifies the

entities that would be involved in the

implementation of regulations that

would be affected by today’s proposal

and the effect of the proposal on

implementation of those regulations.

Category Examples of Entities Effect of Proposal

Lead abatement professionals Workers, supervisors, inspectors, risk assessors,

and project designers engaged in lead-based

paint activities

Provides standards that risk assessors would use to

identify hazards and evaluate clearance tests;

helps determine when certified professionals

would be required to perform abatements

Training providers Firms providing training services in lead-based paint

activities

Provides standards that training providers would

have to teach in their courses

HUD and other Federal agencies

that own residential property

Proposed standards identify hazards that Federal

agencies would have to abate in pre-1960 housing prior to sale

Property owners who receive assistance through Federal housing

programs

State and city public housing authorities, owners of

multi-family rental properties who receive projectbased assistance, owners of rental properties who

lease units under HUD’s tenant-based assistance

program

Proposed standards identify hazards that property

owners would have to abate or reduce as specified by regulations currently be developed by

HUD under authority of Title X, section 1012

Property owners Owner occupants, rental property owners, public

housing authorities, Federal agencies

Proposed standards identify hazards that would

have to be disclosed under EPA/HUD joint regulations promulgated under Title X, section 1018

This table is not intended to be

exhaustive, but rather provides a guide

for readers likely to be affected by this

action through implementation of the

elements of the programs discussed in

this proposal. To determine whether
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30303

you, your business, or your agency is

affected, you should carefully examine

the Requirements for Lead-Based Paint

Activities at 40 CFR part 745, subpart L

and subpart Q and Lead-Based Paint

Disclosure at 40 CFR part 745, subpart

F and 24 CFR part 35, subpart H. The

regulations covering evaluation and

control of lead-based paint hazards in

HUD-associated and Federally-owned

housing are currently under

development. Proposed regulations

were published in the Federal Register

on June 7, 1996 (61 FR 29169). If you

have any questions regarding the

applicability of this action to a

particular entity, consult the person

listed in the ‘‘FOR FURTHER

INFORMATION CONTACT’’ section.

B. Summary of the Proposed Rule

1. Lead-Based Paint Hazard

Standards. EPA is proposing the

amendments in this document primarily

under the authority of section 403 of

TSCA. Section 403 requires EPA to

promulgate regulations that ‘‘identify . .

. lead-based paint hazards, leadcontaminated dust and leadcontaminated soil’’ for purposes of the

entire Title X which includes Title IV of

TSCA. Lead-based paint hazards, under

TSCA section 401, 15 U.S.C. 2681, are

defined as of 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 hazards

from all three sources apply to target

housing (i.e., most pre-1978 housing)

and child-occupied facilities.

The proposed standard for the paint

component, called hazardous lead-based

paint, is lead-based paint in poor

condition. Paint in poor condition is

defined as more than 10 square feet (ft2)

of deteriorated paint on exterior

components with large surface areas,

more than 2 ft2 of deteriorated paint on

interior components with large surface

areas (e.g., walls, ceilings, floors), or

deteriorated paint more than 10 percent

of the total surface area of exterior or

interior components with small surface

areas (e.g., trim, baseboards). The

proposed standards for dust-lead

hazards are the average levels of lead in

dust that equals or exceeds 50

micrograms per square foot (μg/ft2) on

uncarpeted floors and 250 μg/ft2 on

interior window sills. The proposed

standard for soil-lead hazards is the

total lead that equals or exceeds 2,000

parts per million (ppm) based on a yardwide average soil-lead concentration

rather than maximum or worst-case

values.

Although the proposed regulation

does not require property owners to

respond to the presence of lead-based

paint hazards, EPA would recommend

that appropriate measures should be

taken, commensurate with the risk

reduction achieved, to reduce or

eliminate the hazards. Small amounts of

hazardous lead-based paint can be

addressed by repairing deteriorated

paint. Larger amounts of hazardous

lead-based paint should be abated,

meaning that the paint can be removed

from the component, the component can

be replaced, or the paint can be

enclosed.

Dust-lead hazards should be

addressed through intensive cleaning. If

household surfaces are smooth and

cleanable, regular household cleaning

can probably maintain acceptably low

levels of lead in dust in the absence of

any event (e.g., remodeling project) that

reintroduces large amounts of dust

contaminated with lead. Soil-lead

hazards should be eliminated. Currently

available options include soil removal

and permanently covering the soil (i.e.,

paving).

In addition, this document proposes

to identify a soil-lead level of concern

of 400 ppm based on a yard-wide

average, which represents a level at

which risk should be communicated to

the public as compared to the more

active risk reduction measures

recommended for hazards. This level

will not be included in the regulation

because it would impose no legally

recognizable requirements on any

person or entities subject to this

regulation. Nevertheless, if a soil-lead

hazard is not present, but lead in soil

exceeds the level of concern, EPA

recommends that low cost measures,

which may be sufficient to reduce

exposure, be implemented. These

measures include but are not limited to

covering bare soil, placement of

washable doormats, more frequent

washing of hands and toys, and access

restrictions. Access restrictions should

only be used if there are other parts of

the yard that are available to the

residents.

EPA is planning to develop a

guidance document to accompany the

final regulation that will explain these

recommended responses to lead-based

paint hazards and the soil-lead level of

concern in greater detail.

It is important to note that the

proposed 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. These standards would not

be appropriate to use when identifying

the sources of exposure for a leadpoisoned child. When a property is

being evaluated in response to the

identification of a lead-poisoned child,

the risk assessor in cooperation of a

local public health official should

identify and consider all sources of lead

exposure.

The proposed TSCA section 403

standards are based on the best data and

analytical tools currently available to

the Agency. EPA expects that the

standards may need to be modified over

time as better tools and data become

available. The Agency, however,

believes that issuing standards now,

even in the face of considerable

uncertainty, is consistent both with the

public’s need for information from EPA

and the statutory intent to develop

standards with currently available

information.

In this document, EPA is also

proposing amendments to the existing

rules issued under TSCA sections 402

and 404, including: (1) Requirements for

interpreting the results of sampling of

lead materials for purposes of assessing

risk; (2) clearance standards for cleaning

up hazardous lead dust of 50 μg/ft2 for

uncarpeted floors, 250 μg/ft2 for interior

window sills, and 800 μg/ft2 for window

troughs; (3) amendments 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 a soil abatement; and

(5) amendments to the State and Tribal

program authorization requirements

under 40 CFR part 745, subpart Q.

C. Uses of the Standards

The TSCA section 403 standards

support implementation of key

provisions of Title X which would

require action with respect to lead-based

paint hazards by both private parties

and the government, principally for EPA

and programs under the auspices of the

Department of Housing and Urban

Development (HUD). These provisions

include eligibility criteria for the

Department of Housing and Urban

Development’s (HUD) lead hazard

control grant program (section 1011 of

Title X), which authorizes grants to

clean up lead-based paint hazards. In

addition, Title X imposes certain

requirements on owners of HUDassociated housing (section 1012 of Title

X) and Federal agencies selling

residential properties they own to

evaluate and control lead-based paint

hazards (section 1013 of Title X). Sellers

and lessors of housing built before 1978

have obligations to disclose known leadbased paint and lead-based paint

hazards prior to sale or rental (section

1018 of Title X). Regulations also

impose requirements to use certified

workers for evaluation and cleanup of
30304 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

lead-based paint hazards (section 402 of

TSCA). These provisions are described

in more detail in Unit VIII. of this

preamble.

EPA does note, however, that the

regulations would not require private

property owners to undertake hazard

control actions when hazards are

identified. Instead, EPA expects that

concern about children’s health,

liability exposure and other market

forces will provide incentive for

property owners to take action

voluntarily.

In addition to their applicability

within Title X, EPA anticipates that the

TSCA section 403 regulations will have

broader uses. The proposed regulations

will play a significant role in public

education, communicating the Agency’s

best judgment concerning the

identification of lead-based paint

hazards to property owners, State and

local officials, tenants, and other

decision-makers. EPA also expects that

public and private institutions may

incorporate the standards into State and

local laws, housing codes, and lending

and insurance underwriting standards.

D. Limitations of the Proposed Rule

During the regulatory development

process, it became clear that significant

confusion and uncertainty exists about

the requirements and purpose of the

TSCA section 403 regulations. To

address this confusion and uncertainty,

EPA wishes to highlight the major

limitations and other issues related to

the scope and use of today’s proposal.

First, this proposal does not establish

a new definition for lead-based paint,

defined by statute as paint with lead

levels equal to or exceeding 1.0

milligrams per square centimeter (mg/

cm2) or 0.5 percent by weight (see

section 302(c) of the Lead-Poisoning

Prevention Act, 42 U.S.C. 4822(c) and

TSCA section 401(9)). Under Title X,

only the Secretary of Housing and

Urban Development has the authority to

change the standard for lead-based paint

in target housing (see TSCA section

401(9)). Title IV provides EPA the

authority to change the standard only

for lead-based paint in non-residential

applications (e.g., public and

commercial buildings, steel structures)

(see TSCA section 401(9)). This

proposal does not include any changes

to this statutory definition.

Second, the proposed standards are

intended to identify lead-based paint

hazards when the lead-based paint risk

assessment is performed. Because the

conditions of lead-based paint and the

levels of lead in dust and soil are

constantly changing, the results of the

risk assessment communicate

conditions at the time the measurements

are taken and the observations made.

The proposed standards do not address

the potential for hazards to develop.

EPA recognizes, however, that potential

hazards (e.g., intact lead-based paint on

a ceiling) may become actual hazards as

conditions change over time. Periodic

reevaluation of a property would enable

a property owner to determine whether

potential hazards have become actual

hazards. Recommendations concerning

reevaluation will be provided in a

separate guidance document that EPA is

planning to issue.

Third, because the TSCA section 403

standards are established for the

purposes of Title X and TSCA Title IV,

they do not apply to housing and

facilities occupied by children built

during or after 1978, as well as some

pre-1978 housing that is not included in

the definition of target housing (e.g., 0-

bedroom dwellings). EPA recognizes,

however, that property owners and

other decision-makers may be

concerned about the presence of

elevated levels of lead in dust and soil

in housing and facilities occupied by

children not covered by the standards.

In such cases, EPA encourages these

owners and decision-makers to use the

standards to help determine whether

actions should be taken to reduce risks

to young children.

Fourth, the proposed regulations do

not set standards that can be used to

identify housing that is free from risks

associated with exposure to lead. Such

standards would be difficult to define,

unworkable in practice, and

inconsistent with the intent of Title X.

Virtually all target housing has some

lead present in paint, dust, and/or soil,

which, under certain circumstances,

may present risk to children.

Furthermore, these risks often will

depend on circumstances that may

change quickly, such as the physical

condition of the property. Thus, housing

that presents minimal risks when

examined may present substantial risks

later.

E. Preamble Overview

The remainder of this preamble

consists of eleven units. Unit II.

provides background information,

including: a description of the

residential lead-based paint problem;

Title X as a legislative response; key

aspects of the regulatory development

process; and the Agency’s general

standard-setting approach. Unit III. is a

section-by-section review of the

proposed regulatory provisions. Unit IV.

presents EPA’s interpretation of the

statutory authority for the proposed

TSCA section 403 standards, the

Agency’s policy basis for the proposed

standards, and EPA’s decisions for the

proposed TSCA section 403 standards.

This unit includes a summary of the

technical analyses conducted by the

Agency to support these decisions. Unit

V. discusses a range of issues that

affected EPA’s decision-making during

the regulatory development process.

Unit VI. presents EPA’s rationale and

decisions for requirements on

comparing risk assessment sampling

results to the TSCA section 403

standards. Unit VII. describes the

Agency’s rationale and decisions

concerning clearance standards and

other amendments to the TSCA section

402 regulations related to work practice

standards and TSCA section 404

regulations concerning EPA

authorization of State and Tribal

programs. Unit VIII. describes the effect

that today’s proposal will have on other

Title X regulations and programs, and

Unit IX. discusses the relationship

between the proposed regulations and

other EPA programs. Unit X. provides

information on the public record

supporting this regulation (‘‘the

docket’’). Unit XI. presents the

bibliographic references cited in the

preamble, which are also part of the

docket. Unit XII. presents a summary of

the regulatory assessment analyses and

Agency determinations conducted in

response to various Federal laws and

Executive orders concerning the public

health and economic impact of the

proposed regulation.

II. Background

A. Nature of the Problem

Elemental lead is a heavy, soft, and

malleable bluish metal that has been

used for thousands of years. Its

favorable physical and chemical

properties account for its versatility and

extensive use in many common

products including lead acid batteries,

ammunition, chemicals (e.g., plastic

stabilizers, pigments, and ceramic

glazes), alloys (e.g., solder in piping and

electronics), pipe/sheet lead, and

radiation and cable sheathing. Centuries

of mining, smelting, and use have

released millions of tons of lead into the

environment. With no known or

foreseeable technology to render

anthropogenic sources of environmental

lead harmless, it remains ubiquitous in

air, water, soil, dust, and in older homes

and commercial structures. As a result,

practically all people have some

exposure to lead of anthropogenic

origin.

Lead affects virtually every system of

the human body. Exposure to high doses

of lead can cause coma, convulsions,
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30305

and even death. Exposure to low levels

of lead can cause harm gradually and

imperceptibly, with no obvious

symptoms. In adults, chronic exposure

to low levels of lead may cause memory

and concentration problems,

hypertension, cardiovascular disease,

and damage to the male reproductive

system. Exposure to lead before or

during pregnancy can alter fetal

development and cause miscarriages. A

more detailed description of the health

effects of lead can be found in Chapter

2 of the Risk Analysis to Support

Standards for Lead in Paint, Dust, and

Soil, which can be found in the public

record for this proposal (Ref. 1).

While potentially harmful to

individuals of all ages, lead exposure is

especially harmful to children. Their

rapidly developing nervous systems are

particularly sensitive to the effects of

lead. In addition, children absorb a

greater portion of the lead to which they

are exposed than adults do. Excessive

exposure to lead in children causes

learning disabilities, lower intelligence,

behavioral problems, growth

impairment, permanent hearing and

visual impairment, and other damage to

the brain and nervous system.

The concentration of lead in a child’s

blood is typically used as an index of

lead exposure. As recent studies have

identified previously unrecognized

effects of exposure to lead at lower

levels, there has been increasing

concern about blood-lead levels once

thought to be safe. Since 1975, the

Centers for Disease Control and

Prevention (CDC) have lowered the

blood-lead level considered elevated for

children from 40 μg/dl (micrograms per

deciliter) to 10 μg/dl (Ref. 2). Although

the scientific community has not been

able to identify a threshold of exposure

below which adverse health effects do

not occur, the evidence of health effects

below 10 μg/dl is not sufficiently strong

to warrant concern.

Ingestion of lead-contaminated dust

and soil through normal hand-to-mouth

activity appears to be the primary

pathway of lead exposure to U.S.

children under 6 years of age. (Refs. 3

and 4.), Dust is contaminated by lead

when: lead-based paint deteriorates;

lead-based paint is disturbed in the

course of renovation, repair, or

abatement activity; or lead is tracked

into, blown into, or otherwise enters the

home from soil in the yard or other

external sources (e.g., workplace). Soil

contaminated with lead from

deterioration of exterior lead-based

paint, industrial emissions, and/or

deposition of lead from past use of

leaded gasoline may be ingested directly

or contribute to indoor levels of leadcontaminated dust when tracked into

the home. Children may also be exposed

to lead through the ingestion of leadbased paint chips from flaking walls,

windows, and doors or from chewing on

surfaces covered with lead-based paint.

Other sources of lead exposure include,

but are not limited to, leadcontaminated food and drinking water

and occupational exposure to dust and

airborne lead particles.

Considerable progress has been made

in reducing environmental lead levels.

Concrete steps taken by the Federal

government to eliminate sources of lead

include the phase-out of leaded gasoline

by EPA (40 CFR part 80) and the ban by

the Consumer Product Safety

Commission (CPSC) of the production

and sale of lead-based paint for

residential use in 1978 (16 CFR part

1303). The CPSC action placed a

maximum limit on the amount of lead

in paint (0.06 percent by weight) for

residential use, as well as for furniture

and toys. In addition, EPA has

implemented more stringent standards

for lead in drinking water, and the

domestic canning industry voluntarily

eliminated the use of lead in solder to

seal food cans (40 CFR parts 141 and

142).

Consistent with these improvements,

the percentage of children with elevated

blood-lead levels has declined over the

last 20 years. The National Health and

Nutrition Examination Survey

(NHANES) conducted by the National

Center for Health Statistics indicates

that over the past 2 decades the average

child’s blood-lead level has decreased

from 12.8 micrograms/deciliters (μg/dl)

to 2.8 μg/dl (Ref. 5). According to

NHANES III Phase 2, completed in

1994, approximately 900,000 U.S.

children of ages 1 to 5 years had bloodlead levels equal to or exceeding the 10

μg/dl (Ref. 6).

Excessive exposure to lead affects

children across all socio-economic strata

and in all regions of the country.

Children in poor inner-city families,

however, are disproportionately affected

because lead-based paint hazards are

more prevalent in older housing and the

overall ambient level of environmental

lead from all sources tends to be higher

in inner cities (Ref. 7). Studies indicate

that children living in central cities are

three to four times more likely to have

blood-lead levels equal to or exceeding

10 μg/dl than those outside central

cities, with the highest prevalence in

cities where populations exceed 1

million (Ref. 7).

According to EPA’s report on the

HUD National Survey of Lead-Based

Paint in Housing, 83 percent of

privately-owned, occupied homes built

before 1980, or 64.4 million homes,

contain some lead-based paint (Ref. 8).

The likelihood, extent, and

concentration of lead-based paint vary

with the age of the building. Eightyeight percent of privately-owned,

occupied housing units constructed

before 1940, 92 percent of units

constructed between 1940 and 1959,

and 76 percent of units constructed

between 1960 and 1979 contain some

lead-based paint (Ref. 8). Over 12

million (or 19 percent) of these pre-1980

homes with some lead-based paint have

children aged 7 years or younger in

residence (Ref. 8). (The HUD National

Survey presents results for children

aged 7 years or younger; Title X, which

was enacted after the survey was

conducted, focuses upon children

younger than 6 years.)

All homes containing lead-based

paint pose a potential future hazard to

the occupants if the paint is not

managed properly. Intact lead-based

paint may deteriorate over time to create

a hazardous condition. According to

EPA’s analysis of the HUD National

Survey, about 19 percent of pre-1980

privately-owned units contained nonintact lead-based paint in 1989-90,

which was defined at the time of the

survey as greater than 5 square feet of

peeling, chipping, or otherwise

deteriorated paint (Ref. 8). Assuming

that the percent of pre-1980 homes with

non-intact lead-based paint that have

young children is the same as the

percent of pre-1980 homes with some

lead-based paint that have young

children (19 percent), about four percent

of pre-1980 homes in the United States

contained both non-intact lead-based

paint and young children.

Based on the HUD National Survey,

EPA estimates that 13 million or 17

percent of pre-1980 privately-owned

homes have ‘‘elevated’’ lead dust levels,

which were defined at the time of the

Survey as lead dust exceeding 200 μg/

ft2 on floors, 500 μg/ft2 on window sills,

or 800 μg/ft2 on window troughs (Ref.

8). Homes with non-intact lead-based

paint were five times more likely to

have elevated lead dust levels than

homes with intact lead-based paint (Ref.

9).

EPA’s analysis of the HUD National

Survey also estimates that

approximately 16 million or 21 percent

of privately-owned pre-1980 housing

units have soil-lead concentrations

exceeding 400 ppm (Ref. 8). The

prevalence of soil-lead levels exceeding

400 ppm varies greatly with the age of

housing. Sixty percent of pre-1940

units, but only eight percent of 1940-

1959 units and four percent of 1960-
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1979 units have such soil-lead

concentrations (Ref. 9).

B. Structure of Basic Legal Authorities

The Housing and Community

Development Act of 1992 (Pub. L. 102-

550), enacted on October 29, 1992,

contains 16 titles amending and

extending a number of laws relating to

housing and community development.

Title X of this Act, entitled the

‘‘Residential Lead-Based Paint Hazard

Reduction Act of 1992,’’ contains five

subtitles extending and establishing

programs for reducing exposure to lead,

principally, in paint and residential

dust and soil. Provisions of Title X are

codified in the United States Code

(U.S.C.) at volume 42, section 4851 and

at various other sections of volume 42,

as well as of volumes 12 and 15.

Subtitle A of Title X (codified at

volume 42 U.S.C. 4852, and at various

other sections of volumes 42 and 12)

applies primarily to grants and other

programs under the jurisdiction of the

Secretary of Housing and Urban

Development (HUD). Subtitle B of Title

X amends the Toxic Substances Control

Act (TSCA), 15 U.S.C. 2601, et. seq., by

adding Title IV, which requires EPA to

establish requirements for training and

accreditation of contractors performing

lead-based paint related work, issue the

standards being proposed today,

sponsor public education programs,

establish programs for studying the

effectiveness of lead-based paint hazard

evaluation and control products, and

establish a laboratory accreditation

program. Subtitle C of Title X deals with

worker protection and training under

jurisdiction of the Occupational Safety

and Health Administration (OSHA) and

the National Institute of Occupational

Safety and Health (NIOSH). Subtitles D

and E provide for research and reporting

on various aspects of lead-based paint

activities. These last three subtitles are

codified at volume 42 U.S.C. 4853 to

4856.

An overview of the particular

regulatory sections in the Subparts of

Title X that relate to this proposed rule

follows.

1. EPA responsibilities. Under TSCA

section 402 (15 U.S.C. 2682), EPA has

promulgated regulations governing the

training and certification of individuals

and firms engaged in lead-based paint

activities, the accreditation of programs

to train such individuals, and work

practice standards for conducting leadbased paint activities. These regulations

were published in the Federal Register

of August 29, 1996 (61 FR 45778) (FRL–

5389–9), and are codified at 40 CFR part

745, subpart L. EPA will amend these

regulations at a later date to address

deleading in public and commercial

buildings, and other structures, such as

bridges.

In conjunction with these activities,

EPA developed specific guidelines

under section 402(c)(1) for renovation

and remodeling activities that may

create a risk of exposure to dangerous

levels of lead (Ref. 10). Under TSCA

section 402(c)(3), EPA is required to

revise the certification and accreditation

regulations under 40 CFR part 745,

subpart L, to address renovation and

remodeling activities that create leadbased paint hazards, after conducting a

study of such activities.

In conjunction with the TSCA section

402 rule, EPA, under TSCA section 404

(15 U.S.C. 2684), developed a Model

State Program, which States and Indian

Tribes are encouraged to reference and

use as guidance to develop their own

Federally-authorized lead-based paint

activities programs. The regulations in

40 CFR part 745, subpart Q, include

procedures for States and Indian Tribes

to follow when applying to EPA for

authorization to administer and enforce

a State or Tribal training, accreditation,

and certification program.

Under TSCA section 406(a) (15 U.S.C.

2686(a)), EPA, HUD, and CPSC jointly

released a lead hazard information

pamphlet, Protect Your Family from

Lead in Your Home (60 FR 39167,

August 1, 1995) (FRL–4966–6). The

pamphlet is designed to educate

families about the potential health risks

associated with lead exposure and ways

to avoid such exposure.

Under TSCA section 406(b), EPA has

promulgated a regulation to require

persons performing renovation work for

compensation in residential housing

built before 1978 to provide owners and

occupants with a lead hazard

information pamphlet before renovation

begins.

Under Title X, section 1018 (42 U.S.C.

4852(d)), 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 or lead-based paint

hazards to the purchaser or lessee (24

CFR part 35, subpart H; 40 CFR part

745, subpart F). Under these rules, the

seller or lessor also must provide the

purchaser or lessee any available

records or reports pertaining to such

paint or hazards and a copy of the lead

hazard information pamphlet.

Additionally, the seller must allow the

purchaser 10 days to conduct an

inspection or risk assessment for the

presence of lead-based paint or leadbased paint hazards. Finally, the sale or

leasing contract must include certain

disclosure and acknowledgment

provisions, and real estate agents must

ensure compliance with these

standards.

2. HUD responsibilities. In addition,

to the joint regulations issued with EPA

under section 1018 of Title X, HUD has

a number of programs under its own

authorities that will be affected by the

rule.

Under section 1011 of Title X (42

U.S.C. 4852), HUD provides grants to

State and local governments to evaluate

and reduce lead-based paint hazards in

pre-1978 housing that qualifies as

affordable housing and is not Federallyassisted, Federally-owned, or public

housing.

Under Title X sections 1012 and 1013,

HUD is required to establish lead-based

paint hazard notification, evaluation,

and reduction requirements for HUDassociated housing and Federallyowned housing under provisions

codified at various parts of 42 U.S.C.

These regulations, which HUD proposed

on June 7, 1996 (61 FR 29170), will

establish programmatic lead-based paint

hazard notification, evaluation, and

reduction requirements and will

describe how these activities should be

performed. The latter set of standards

are based on the detailed HUD

Guidelines for the Evaluation and

Control of Lead-Based Paint Hazards in

Housing (hereinafter HUD Guidelines)

(Ref. 11), which HUD developed under

Title X section 1017 (42 U.S.C. 4852c),

and on EPA’s TSCA section 402

standards described above. The HUD

Guidelines reflect input from housing,

public health, and environmental

professionals with broad experience in

lead-based paint hazard identification

and control.

3. Other agencies. The Department of

Health and Human Services (HHS),

CPSC, the Department of Labor, and

other Federal agencies have contributed

to the development of standards and

other programs under Title X, including

through their consultation with EPA

and HUD. EPA, HUD, and CPSC jointly

released the lead hazard information

pamphlet in consultation with CDC.

Under section 1031 of Title X (subpart

C), OSHA promulgated interim final

employee protection requirements for

construction workers exposed to lead,

which apply to lead-based paint

activities in residential housing and

other construction settings (29 CFR

1926.62).

C. Regulatory Development Process

EPA began development of the

proposed rule immediately following

enactment of Title X. The Agency

quickly encountered significant

challenges in its design and
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30307

implementation of the risk and

economic analyses needed to guide

selection of the standards. Recognizing

the growing need for advice on this

issue, EPA released an interim guidance

document in July 1994 to provide public

and private decision-makers with

guidance on identifying and prioritizing

lead-based paint hazards for control.

The recommendations in the guidance

represented the Agency’s best judgment

given the state of knowledge at the time.

EPA subsequently published the interim

guidance document in the Federal

Register of September 11, 1995 (60 FR

47248) (FRL–4969–6). The interim

guidance will continue to serve as EPA’s

official policy until EPA promulgates

final standards under TSCA section 403.

The TSCA section 403 regulations are

a significant component of the national

lead-based paint hazard reduction

program. As such, these regulations will

likely have a broad impact on public

health and housing. In light of these

potential impacts as well as intense

interest in this proposed rule expressed

by a large number of stakeholders, EPA

established a Dialogue Process to

provide a forum where EPA could

obtain input early in the rulemaking

process from representatives of a range

of groups that have an interest in the

TSCA section 403 regulations.

Interested parties included leadpoisoning prevention experts,

environmental advocates, housing

providers, the lead industry, State and

local governments, the banking and

insurance industries, and the lead risk

assessment and abatement industry.

EPA did not use the Dialogue Process to

develop a consensus among the

participants, but rather used the Process

to gather individual points of view.

Meetings were open to the public and a

summary of each meeting was placed in

the public record for this proposed rule

(Refs. 12-16).

EPA held five meetings using the

Dialogue Process: October 19, 1995;

December 14, 1995; February 15, 1996;

March 21, 1996; and November 12,

1997. The first four meetings focused on

a range of policy and implementation

issues for which EPA presented a range

of potential options. Participants

commented on these options and

sometimes suggested options EPA had

not previously considered. Dialogue

Process participants also identified

issues EPA had not presented to the

group. The Dialogue Process did not

address questions related to the risk

analysis or the technical basis for the

rule. These are important and difficult

issues but were beyond the scope of the

policy level input EPA was seeking from

the Dialogue. The Agency, instead,

presented its risk analysis document for

an expedited peer review in August

1997. Comments provided by the

reviewers can be found in the public

record for this proposed rule. EPA will

also ask its Science Advisory Board

(SAB) to review the risk analysis during

the public comment period for today’s

proposed rule. The SAB report will also

be placed in the public record, and EPA

will consider this report in its

development of the final rule.

At the final meeting, EPA staff

presented a draft of the options for the

proposed rule being recommended to

senior Agency managers. This meeting

provided an opportunity for interested

parties to express their concerns about

the current direction of the proposed

rule and allowed EPA to address these

concerns by clarifying the Agency’s

rationale or by seeking additional input.

By addressing the concerns of interested

parties in the proposal, EPA hopes to

facilitate the process of finalizing the

proposed regulations.

In addition to the Dialogue Process,

EPA staff met with the public in a

variety of other forums to discuss issues

related to the rule. These forums

included conferences sponsored by

trade associations, seminars sponsored

by real estate groups (e.g., Owners and

Managers Group of the Mid-Atlantic

Region, Real Estate Board of New York)

and legal publications (e.g., New York

Law Journal), and meetings with

interested parties. In most of these

settings, EPA staff provided an update

on the status of the rulemaking and

responded to questions. Occasionally,

EPA met with interested parties to

obtain information on specific issues of

concern. For example, Agency staff met

with representatives of rental property

owners to gauge owner response to the

regulatory standards. In several

instances, interested parties requested

meetings with EPA to provide their

perspective on specific regulatory and/

or technical issues. EPA has placed a

summary of all meetings between its

staff and interested parties in the public

record for this proposed rule (Ref. 17).

EPA did not prepare summaries of

presentations delivered at conferences

and seminars.

D. General Approach to Standard

Setting

Before EPA could formulate and

analyze options for the TSCA section

403 standards, the Agency had to

develop an overall approach for the

rulemaking. EPA’s standard-setting

approach was based on the outcome of

two decisions. The first decision was

whether the Agency should develop

uniform national standards or standards

that are targeted (e.g., to specific

communities or populations). The

second decision was whether EPA

should develop independent, mediaspecific standards or joint standards.

This unit presents EPA’s analysis of

these issues and its decisions.

1. Uniform, national standards, or

targeted standards. The establishment

of the standards in today’s proposal

required estimates of the relationship

between environmental lead levels

(from paint, dust, and soil) and their

effects on the health of exposed

children. This relationship is extremely

complex, and is dependent upon

numerous site-specific and childspecific factors. These estimates are

more accurate on a smaller (residence or

community) scale, where more sitespecific factors can be considered.

A targeted approach to standardsetting (i.e., community- or residentspecific standards) would result in

numerically different standards for each

residence or community. Developing

national standards, on the other hand,

would produce the same numerical

standard for all residences and

communities, but with an attendant loss

of accuracy. That is, national standards

would be more protective at some

locations and less protective at others

because national standards would not

account for community- or residencespecific factors.

EPA decided, based on considerations

of feasibility and ease of

implementation, that national standards

are the most appropriate regulatory

approach. First, the data needed to

establish standards at a smaller scale are

neither collected under the Title X

program nor available for communities

nationwide. Much of the necessary

residence-specific data could be

collected to establish residence-specific

standards, but lead-based paint risk

assessments would have to be broader

in scope (i.e., include water sampling

and sampling of other ambient

environmental levels) and more costly

than currently envisioned. Even then,

residence-specific standards would not

account for variability in exposure

influenced by child-specific factors (e.g.,

hand-to-mouth behavior, hygiene,

nutrition). Community-specific data

would require new resource-intensive

data collection efforts (e.g, patterns of

soil contamination, water lead levels).

In contrast, national data on lead in

paint, dust, and soil are currently

available.

Second, uniform national standards

are easier to implement. National

standards provide a fixed basis of

comparison for all homes. National

standards can also be used to compare
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properties and establish priorities. In

contrast, with residence-specific

standards, there would be millions of

standards. Such a regulation would be

largely unworkable. Property owners

and other decision-makers would not

know what standard would apply until

a hazard evaluation was conducted.

Rental property owners who own

multiple properties would be working

with a different standard for each

property. In addition, residence-specific

standards would not help establish

priorities because it would be extremely

difficult to compare the relative needs of

different properties.

In making this decision, the Agency

was also mindful that certain segments

of the population have a higher

incidence of elevated blood-lead levels

(e.g., some minority children in innercity neighborhoods) and a case could be

made for proposing more stringent

standards for particular neighborhoods.

However, 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.

In light of the recently released

NHANES III, Phase 2 data, EPA

considered an alternative option under

which uniform standards would only be

effective in higher risk communities.

EPA, however, rejected this option

because there is insufficient data to

definitively identify these higher risk

communities. In addition, the

development of standards for higher risk

communities would introduce

significant complexities. First, EPA

would have to establish criteria for

identifying these communities. Second,

the Agency would have to develop a set

of standards for each category of

community. Third, EPA would have to

develop an approach for addressing

neighborhoods that border on higher

risk communities. As an alternative, the

Agency believes that an effective and

simpler approach to address vulnerable

communities is through program

implementation (e.g., training,

education, and environmental justice

grants).

EPA also wishes to note that Congress

envisioned that important elements of

the Title X program would be delegated

to the States. Accordingly, the Agency

preferred to establish a simple, minimal

set of standards that could easily be

adopted by States and allow them to

tailor the standards (i.e., by considering

more site-specific factors), should they

so choose. Consequently, States will

have greater flexibility in establishing

and implementing their programs while

a national, baseline level of protection

to children is maintained.

Because the decision to set uniform

national standards has a significant

impact on the standard-setting process,

EPA is interested in obtaining comment

on this issue. The Agency would like

specific input on how EPA should set

standards that will ensure national

resources are targeted commensurate

with risk.

2. Joint, media-specific standards vs.

joint standards. The second 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 the standard for

each medium without considering the

conditions in the other media. For

example, the standard for soil would not

be affected by the level of lead in dust.

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. The main disadvantage is that the

standard for each medium may not

correspond to total exposure and risk.

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

example, the Agency could graphically

represent combinations of hazardous

levels of lead in dust and soil with a

downward sloping line. In this graph,

shown in Figure 1, the horizontal axis

could depict the level of lead in soil.
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30309

The vertical axis could depict the level

of lead in dust. Any point on this chart,

therefore, would illustrate a

combination of lead dust and lead soil

levels. The downward sloping line

would intersect the horizontal axis at

the point representing the highest

acceptable level of lead in soil if there

is no lead in dust. The line would

intersect the vertical axis at the point

representing the highest acceptable level

of lead in dust if there were no lead in

soil. All points above the line would be

defined as hazardous. To incorporate

the condition of paint into the joint dust

and soil standards, the Agency, in

theory, could establish two downward

sloping lines: one for homes with no

deteriorated lead-based paint and

another for homes with deteriorated

lead-based paint. The major advantage

of the joint standards is that they better

reflect the total exposure and risk. On

the other hand, joint standards are more

difficult to explain, understand, and

use.

Normally, EPA would tend to favor

the approach that better reflects risk to

human health. Certainly the joint

standard approach described above

would be the approach of choice in

evaluating the environmental risks to a

child in a specific house. In the context

of this proposed rule, however, EPA has

concluded that single, medium-specific

standards would be far more workable

than joint standards for many of the

same reasons that national standards are

more workable than targeted standards.

First, media-specific standards provide

a fixed basis of comparison for all

homes and can be used to compare

properties and establish priorities.

Second, EPA believes that fixed

numerical standards are more easily

understood than standards that require

an understanding of mathematical

relationships. In addition, the Agency

does not currently possess the analytical

techniques necessary to relate dust

loadings to soil concentrations, the

measurement basis for the dust and soil

standards. Consequently, EPA lacks a

technical method to establish joint

standards.

III. Section-by-Section Review of the

Proposed Rule

This unit of the preamble provides a

section-by-section explanation of the

proposed regulations. The proposed

regulations consist of five components:

the proposed section 403 standards for

lead-based paint hazards; amendments

to the final section 402 regulations;

amendments to the final section 404

regulations; and definitions for specific

terms. The unit focuses on the proposed

section 403 standards, the proposed

amendments to the final section 402

regulations, and the amendments to the

final section 404 regulation. The

definitions are discussed in relation to

the relevant proposed regulatory

provisions. Furthermore, the definitions

in proposed § 745.63 that already exist

in 40 CFR 745.223 are not subject to

public comment.

A. Proposed Section 403 Standards

The TSCA section 403 standards

consist of three parts: scope and

applicability; the standards for leadbased paint hazards; and provisions for

implementing the standards.

1. Scope and applicability. The scope

and applicability part of the standards,

which is stated in proposed § 745.61,

would establish that the proposed

standards would apply to target housing

(i.e., most pre-1978 housing) and childoccupied facilities.

This part of the proposed rule also

makes it clear that the TSCA section 403

standards do not require the owner of

properties covered by this proposed rule

to evaluate his/her properties for the

presence of lead-based paint hazards, or

to take any action to control these

conditions if one or more of them is

identified.

2. Standards for lead-based paint

hazards. The proposed standards for

lead-based paint hazards are codified in

proposed § 745.65. Proposed § 745.65(a)

states that hazardous lead-based paint

includes lead-based paint in poor

condition. Proposed § 745.63 defines

paint in poor condition as more than 10

square feet of deteriorated paint on

exterior components with large surface

areas, more than 2 square feet of

deteriorated paint on interior

components with large surface areas

(e.g., walls, ceilings, floors), or

deteriorated paint on more than 10

percent of the total surface area of

interior or exterior components with

small surface areas (e.g., trim,

baseboards). EPA is not proposing

hazardous lead-based paint standards

for accessible surfaces and friction and

impact surfaces. The Agency, instead,

has presented a range of options for

these standards, which are discussed in

Unit IV.D.2 and IV.D.3. of this preamble.

EPA is seeking public comment on these

options and will promulgate standards

as part of the final rule based on these

options and consideration of public

input.

Proposed § 745.65(b) identifies dustlead hazards in terms of lead loading

and location. Lead loading is the

quantity of lead present per unit of

surface area (e.g., micrograms per square

foot). The proposed dust-lead hazard

standard is 50 μg/ft2 for uncarpeted

floors and 250 μg/ft2 for interior window

sills. The proposed rule does not

include a dust-lead hazard standard for

carpeted floors or for window troughs.

Proposed § 745.65(c) identifies soillead hazards in terms of lead

concentration. Lead concentration is the

relative content of lead within the soil

measured in parts per million by

weight. The proposed standard for soillead hazard is 2,000 ppm.

3. Proposed requirements for

implementing the standards. This part

of the proposal describes the

requirements for how a certified risk

assessor would compare on-site

observations and sampling results to the

standards to determine whether leadbased paint hazards are present. The

general requirements are in § 745.69.

EPA has incorporated the specific

requirements, which are summarized in

Table 1 below, into the work practice

standards for lead-based paint activities

found at 40 CFR 745.227.

Proposed § 745.69 would establish

that the determination requirements are

applicable to the standards for leadbased paint hazards. It also states that

the determination would have to be

made by a certified risk assessor

performing a risk assessment according

to the risk assessment work practice

standards. Third, the proposed

regulations state that, for purposes of

determining the presence of a dust-lead

hazard, the risk assessor must compare

the weighted arithmetic means of the

samples to the applicable standard. For

purposes of determining the presence of

soil-lead hazards, the risk assessor must

compare the arithmetic means of the

samples to the applicable standard.

Table 1.—Summary of Regulations for Determining the Presence of Lead-Based Paint Hazards

Type and Location of Hazard/Contamination Method

Hazardous lead-based paint: lead-based paint in poor condition Visual assessment for condition of paint; test paint; assume all like surfaces that have similar painting history contain lead-based paint if

tested component has lead-based paint
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Table 1.—Summary of Regulations for Determining the Presence of Lead-Based Paint Hazards—Continued

Type and Location of Hazard/Contamination Method

Dust-lead hazard: uncarpeted floors (single-family and sampled units

and common areas in multi-family)

Compare weighted arithmetic mean lead loading of all samples for

uncarpeted floors to the hazard standard for floors

Dust-lead hazard: interior window sills (single-family and sampled units

and common areas in multi-family)

Compare weighted arithmetic mean lead loading of all samples for interior window sills to the hazard standard for sills

Dust-lead hazard: uncarpeted floors (unsampled units and common

areas in multi-family)

Assumed to be hazard if hazard is present in any sampled unit or common area of the same type

Dust-lead hazard: interior window sills (unsampled units and common

areas in multi-family)

Assumed to be hazard if hazard is present in any sampled unit or common area of the same type

Soil-lead hazard Compare arithmetic mean of dripline and mid-yard samples to hazard

standard

Proposed § 745.227(h) would

establish the specific requirements for

how to determine whether lead-based

paint hazards are present. To determine

whether hazardous lead-based paint is

present, the risk assessor must test paint

that is in poor condition. The paint on

all surfaces with paint in poor condition

need not be tested. The risk assessor,

however, must assume that untested

surfaces contain lead-based paint if

tested surfaces that have a similar

painting history contain lead-based

paint.

To determine whether a dust-lead

hazard is present, the risk assessor must

compare the weighted mean (i.e.,

weighted average) of all single surface

samples or all composite samples to the

appropriate dust-lead hazard standard

(i.e., uncarpeted floors, interior window

sills).

In multi-family housing, where risk

assessors have the option not to collect

dust samples in every residential unit or

common area, the approach described in

the previous paragraph applies to all

sampled residential units and common

areas where samples were collected. For

residential units or common areas

where samples are not collected, the

risk assessor would have to make

assumptions based on the results of

sampled residential units and common

areas. If at least one sampled residential

unit or common area exceeds the hazard

standard for a specific surface (i.e,

floors, sills), then the risk assessor

would have to assume that hazards exist

on that surface in all unsampled

residential units and common areas. It

should be noted that risk assessors

always have the option to collect

samples from all units and common

areas at a multi-family property.

Proposed § 745.227(h) also would

establish the requirements for how to

determine whether a soil-lead hazard is

present. Under the proposal, the risk

assessor must compare the mean of a

composite sample from the dripline and

a composite sample from the mid-yard

for each residential building to the

standards to determine whether a

hazard is present. If the risk assessor

collects more than one composite in

either the dripline or the mid-yard for

a building, he or she should compute

the average of the composites from each

area and use those averages to compute

the average concentration for the

dripline and the mid-yard.

Proposed § 745.63 defines the dripline

and mid-yard. The dripline is the area

within 3 feet surrounding the perimeter

of a building. The mid-yard is the part

of yard that lies halfway between the

outermost edge of the dripline and

property line or between the outermost

edge of the dripline and the outermost

edge of the dripline of another

residential building on the same

property. This approach applies to both

properties with a single residential

building and to those with more than

one residential building.

B. Proposed Amendments to the Final

Section 402 Regulations

Today’s action includes proposed

amendments to the final TSCA section

402 work practice regulations for leadbased paint activities at 40 CFR 745.227.

The proposed amendments would

establish clearance standards for dust,

limit reuse of abated soil, add a

requirement for interpreting composite

dust clearance samples, and change risk

assessment and clearance sampling

requirements to ensure compatibility

between sampling results and the TSCA

section 403 standards and section 402

clearance standards. Unit IX. of this

preamble discusses these amendments

and the Agency’s rationale and

supporting analyses for its decisions.

Today’s action proposes to amend the

abatement work practice standards at 40

CFR 745.227(e) by adding clearance

standards for dust. A risk assessor

performs clearance testing to evaluate

the adequacy of post-abatement dust

cleaning. The proposed clearance

standards are 50 μg/ft2 for uncarpeted

floors, 250 μg/ft2 for interior window

sills, and 800 μg/ft2 for window troughs.

Second, today’s action includes a

proposed amendment to the abatement

work practice standards at 40 CFR

745.227(e) to prohibit the reuse of soil

removed during an abatement as top soil

in another residential yard or childoccupied facility. The current

regulations do not provide any

management controls for the soil.

Third, today’s proposal includes an

amendment to the abatement work

practice standards at 40 CFR 745.227(e)

to add a requirement for interpreting

composite dust samples for clearance.

The current regulation does not

differentiate between single surface

samples and composite samples. The

proposed amendment would require the

risk assessor to compare the composite

sample to the clearance standard

divided by the number of subsamples in

the composite. For example, if the

composite contains four subsamples, the

risk assessor would compare the

composite to the clearance standard

divided by four.

Fourth, the Agency is proposing that

the risk assessment work practice

standards at 40 CFR 745.227 be

amended to require that risk assessor

collect dust samples from uncarpeted

floors and interior window sills because

EPA is proposing dust-lead hazard

standards for uncarpeted floors and

window sills. Today’s proposal also

includes an amendment to the

abatement work practice standards at 40

CFR 745.227(e) to require that a risk

assessor collect dust clearance samples

from uncarpeted floors, window sills,

and window troughs because EPA is

proposing clearance standards for all

three surfaces. The current risk

assessment and abatement work practice

standards require risk assessors to

collect dust samples from windows

without specifying the part of the

window. The Agency is also proposing

to amend the risk assessment work

practice standards to change the
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30311

location of soil samples from the

dripline and ‘‘play area’’ to the dripline

and mid-yard.

C. Proposed Amendments to the Final

Section 404 Regulations

Today’s action includes proposed

amendments to the final TSCA section

404 States/Tribal program authorization

regulations found at 40 CFR part 745,

subpart Q. These proposed amendments

would require States/Tribes that are

seeking program authorization and

States/Tribes that already have applied

for authorization and wish to retain it to

incorporate lead-based paint hazard

standards that are as protective as the

Federal standards no later than their

first report to EPA after years following

the promulgation of the TSCA section

403 standards.

States/Tribes seeking authorization

for the first time would include their

standards in their program application,

the requirements for which are

described in 40 CFR 745.320 to 40 CFR

745.325. Proposed amendments to

§ 745.325, would explicitly clarify that

lead-based paint hazard standards and

implementation requirements are

necessary components of the risk

assessment work practice standards in

§ 745.325(d)(2). States/Tribes seeking to

retain program authorization would

describe their standards in their regular

report to EPA in accordance with 40

CFR 745.324(h).

IV. Development of this Proposed Rule

This unit of the preamble presents

EPA’s analysis of its legal authority, and

describes the Agency’s policy basis,

technical analyses, and decisions for the

proposed section 403 standards. Section

A discusses EPA’s legal authority and

policy basis for the standards. Section B

discusses the technical analysis to

support the development of the

proposed standards for dust and soil.

Section C presents EPA’s analysis of the

options for dust and soil standards and

explains the Agency’s decisions. Section

D presents the analysis of the options

for the paint hazard standard and

explains the Agency’s decisions. The

standard for lead-based paint, as further

explained below, is defined by statute

and EPA is not modifying that standard

in this proposed rule.

A. Authority for Today’s Action

1. Statutory mandate and related

definitions. Section 403 of TSCA is the

key statutory provision for today’s

proposed regulation. It requires EPA to

identify three terms—lead-based paint

hazards, lead-contaminated dust, and

lead-contaminated soil. For reasons

explained below, EPA needs to first

define lead-contaminated dust and soil

before it may define lead-based paint

hazards. These three terms and other

definitions that help define them are

found in both TSCA section 401 (15

U.S.C. 2681) and in section 1004 of Title

X (42 U.S.C. 4851b). Because the

definitions in both of these sections are

identical for practical purposes, the

remainder of this preamble will cite the

TSCA definitions. Below, EPA explains

how the definitions affect the Agency’s

responsibilities in this proposed rule.

TSCA section 401(10) defines ‘‘leadbased paint hazard’’ to mean any

condition that causes exposure to lead

from lead-contaminated dust, leadcontaminated soil, lead-contaminated

paint that is deteriorated or present in

accessible surfaces, friction surfaces, or

impact surfaces that would result in

adverse human health effects . . .

[emphasis added].

Thus, there are three sources that may

contribute to the existence of a leadbased paint hazard—lead-contaminated

paint, lead-contaminated dust, and leadcontaminated soil.

EPA interprets lead-contaminated

paint to mean the same as ‘‘lead-based

paint,’’ which is defined by TSCA

section 401(9) to mean paint or other

surface coatings that contain lead in

concentrations equaling or exceeding

limits established under section 302(c)

of the Lead Based Paint Poisoning

Prevention Act (42 U.S.C. 4822(c)).

Currently, this limit is lead content that

equals or exceeds 1.0 milligrams per

square centimeter (mg/cm2) or 0.5

percent by weight. EPA is not taking any

action in this proposed rule to redefine

lead-based paint.

It must be emphasized that lead-based

paint is not a risk-based term. It is only

a benchmark that identifies material

subject to the jurisdiction of various

authorities of TSCA and Title X.

Instead, the term ‘‘lead-based paint

hazard’’ will identify those conditions

of lead-based paint that would result in

adverse health effects. The statutory

language makes it clear that not all leadbased paint is to be considered a leadbased paint hazard. In fact, for lead

paint to be a hazard it must, at least, be

deteriorated or be present on friction or

impact surfaces or on surfaces

accessible for young children to mouth

or chew. Deteriorated paint is defined in

TSCA 401(3). Friction, impact, and

accessible surfaces are defined in TSCA

401(2), (5) and (6).

Lead-based paint hazards,

furthermore, are not limited to the

hazards from paint, alone, because they

include conditions that cause exposure

to residential lead-contaminated dust

and soil, regardless of the source of lead.

EPA is responsible in this proposed rule

for identifying what constitutes leadcontaminated dust and soil. Both terms

are limited to dust and soil in

residences, in contrast to lead paint,

which may be found in public and

commercial buildings and in other

structures, such as bridges or

superstructures (e.g., water towers).

Lead-contaminated dust means

surface dust in residential dwellings

that contains lead determined by EPA to

pose a threat of adverse health effects in

pregnant women or young children

[emphasis added] (TSCA 401(11)). Leadcontaminated soil means bare soil on

residential property that contains lead

that is determined to be hazardous to

human health by EPA (TSCA 401(12))

[emphasis added].

The lead-based paint hazard

definition contains the overarching legal

standard applicable to today’s proposed

regulation. In pertinent part, the

definition means any condition that

causes exposure to lead-contaminated

dust, soil, or paint that would result in

adverse human health effects. To

determine what constitutes leadcontaminated dust or soil, on the other

hand, EPA interprets the statute to

require a less rigorous level of certainty

regarding the likelihood of adverse

effects occurring to establish the

standards.

2. Statutory criteria for leadcontaminated dust and soil, and leadbased paint hazards. Given the

definitions of lead-based paint hazards,

lead-contaminated dust, and leadcontaminated soil in TSCA section 401,

EPA needs to establish standards for

lead-contaminated dust and soil

separately from lead-based paint

hazards. Put simply, not all leadcontaminated dust or lead-contaminated

soil (or lead-based paint) needs to be

considered hazardous. In fact, as

explained below, the definitions in

TSCA section 401 support the Agency’s

adoption of a weight of evidence

approach for setting the varying

standards.

To help differentiate between leadcontaminated dust and soil and leadcontaminated dust and soil that are

lead-based paint hazards, and to

alleviate the confusion created by this

terminology, the Agency will generally

refer to lead-contaminated dust and soil

that meet the lead-based paint hazard

criteria as dust-lead hazards and soillead hazards. EPA will refer to the paint

component of lead-based paint hazards

as hazardous lead-based paint.

a. Contamination standards. As

indicated above, EPA believes that the

term ‘‘poses a threat,’’ used to define
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lead-contaminated dust, connotes a

lower level of certainty regarding risk

than the term ‘‘would result in adverse

effects,’’ used to define lead-based paint

hazard, and indicates that the standard

for lead-contaminated dust requires a

lesser weight of evidence of harm. The

level of certainty associated with the

term ‘‘hazardous to human health,’’

which is used to define leadcontaminated soil, is less clear. The

overall structure of the definitions in

section 401, however, indicates parallel

treatment for lead-contaminated dust

and soil. EPA is, therefore, interpreting

‘‘poses a threat’’ and ‘‘hazardous to

human health’’ to be associated with the

same level of evidence needed to

determine risk.

The terms ‘‘lead-contaminated’’ dust

and soil, therefore, describe the universe

of lead in soil and dust about which

there may be some level of concern.

Within this universe are levels of leadcontaminated dust and soil that result in

lead-based paint hazards, which

engender greater concern because there

is greater certainty of risk of adverse

human health effects. Identifying

hazardous paint, dust, and soil,

therefore, requires a greater weight of

evidence of harm.

The terms lead-contaminated dust

and lead-contaminated soil, while

necessary components of the definition

of lead-based paint hazards, do not

appear anywhere else in Title X. Thus,

they 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 soil associated with soil-lead

hazards. EPA concludes from this

observation that the purpose for

identifying lead-contaminated dust and

soil separately from hazardous dust and

soil is to identify levels of dust and soil

contamination for which there are lower

levels of certainty regarding adverse

effects and general population concern,

but about which owners and occupants

of residential property should be aware.

Individual owners and occupants may

wish to make decisions based on the

lesser level of certainty. To convey this

message, EPA has decided to call the

standards for lead-contaminated dust

and soil, dust-lead and soil-lead ‘‘levels

of concern.’’ EPA has decided that the

levels of concern should be based solely

on their potential to pose a threat to

human health, without regard to

whether taking action on these levels

could result in significant risk

reduction, or whether the resources that

persons may choose to expend on

dealing with dust and soil at these

levels are commensurate with any

potential risk reduction.

Because the level of concern does not

affect other activities under Title X or

TSCA Title IV, EPA has decided not to

include the levels of concern in the

proposed regulation. Nevertheless,

because the level of concern

communicates important risk

information to property owners and

occupants, the Agency believes that it is

important to include the levels of

concern in the preamble and guidance

that will accompany the rule. At this

point, the Agency is only proposing to

adopt in guidance a separate level of

concern for lead in soil, which is

discussed in detail in Unit IV of this

preamble. The Agency has decided that

there should not be a separate dust-lead

level of concern, even in guidance,

because EPA’s analysis shows that dustlead level of concern should be the same

as the dust-lead hazard standard. The

Agency believes, therefore, that having

a separate dust-lead level of concern

would not provide useful additional

information to the public.

EPA is interested in public input with

respect to the inclusion of the levels of

concern, particularly for soil, in the

regulatory text of the document.

Specifically, EPA is seeking comment

on whether the absence of the soil-lead

level of concern in the regulation would

diminish the visibility of the level and

reduce its usefulness as a risk

communication tool, or whether the

soil-lead level of concern would be

treated as the de facto hazard standard

if it were included in the regulation.

EPA does not believe that the public

should confuse the soil-lead level of

concern in the guidance, with the soillead hazard standard in the regulation.

As indicated above, the Agency is

specifically interested in comments on

this issue.

b. Hazard standards. The

determination of what constitutes leadbased paint hazards--hazardous paint,

dust, and soil--will require a more

elaborate analysis. Clearly, the statutory

criterion for hazard, ‘‘would result in

adverse human health effects,’’ means

that lead-based paint hazards are

associated with a higher level of risk

than levels of concern. The challenge to

the Agency is how to identify the higher

level of risk.

Based on the language of section 403,

the purposes of Title X and its

legislative history, and basic policy

discussions explained below, EPA

determined that it should identify this

higher level of risk based on

consideration of the potential for risk

reduction of any action taken

(considering uncertainties in 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.

The use of the term ‘‘would result’’ in

the statutory criteria --‘‘would result in

adverse human health effects’’--implies

certainty of adverse outcome. This

interpretation is supported the by

legislative history discussed in the

Senate Committee Report (National

Affordable Housing Act Amendments of

1992, Report of the Committee on

Banking, Housing and Urban Affairs, S.

Rep. 102-332, 102d Cong., 2nd Sess., at

112 (hereinafter ‘‘Senate Report’’)). The

Senate Report states that Title X ‘‘limits

the definition of hazard, and thus the

scope of the bill to actual hazards--

conditions that cause [ ] exposure to

lead . . . that would result in adverse

human effects’’ [emphasis added]

(Senate report, page 112).

Dealing with what would constitute

an ‘‘actual’’ effect is the dilemma posed

by the statutory language. EPA’s

interpretation of the broader Title X

framework suggests that lead-based

paint hazard standards should not be

based on absolute certainty. If the EPA

were to follow Congress’ literal wording,

available evidence would only allow the

Agency to set unreasonably high dust,

soil, or paint hazard standards. EPA

does not believe that this is an

appropriate formulation of

Congressional intent. As stated in

section 1103(3), one purpose of Title X

is ‘‘to encourage effective action to

prevent childhood lead poisoning’’

(emphasis added). To follow this

directive, EPA needs to establish hazard

standards that predict adverse health

outcomes based on their environmental

observations and measurements. Due to

the large amount of variability in the

relationship between environmental

lead levels and blood-lead

concentrations, it is not possible to state

with certainty that a given set of

environmental conditions would result

in an actual adverse outcome. EPA,

therefore, has not used an absolute

certainty criterion but rather interprets

the statute to require a level of certainty

regarding risk that is higher than that

used for the contamination standard—

the ‘‘level of concern.’’

It is possible, however, to state that

there is a relatively high likelihood that

an adverse outcome will occur. The

dilemma the Agency faces in this case

would be that hazards would be

identified only at the very highest

levels. Thus, for example, EPA could

say that adverse effects ‘‘would result’’

only when an individual child has a 100

percent probability of having a blood-
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30313

lead concentration equal to or exceeding

10 μg/dl. Using this 100 percent

probability criterion as the basis for

setting hazard standards, however,

would contribute little, if anything, to

the statutory intent of preventing

adverse effects. Moreover, the

environmental lead levels associated

with this probability level would be so

high that they would likely apply to

only a very small number of situations-

-for example, soil levels well over 5,000

ppm or dust lead levels well over 500

μg/ft2. Children exposed to significantly

lower levels could be subject to

substantial risk that would be ignored in

the national lead program. Therefore,

EPA has elected not to use such a

formulation.

Accordingly, EPA examined the

statute and its legislative history for

guidance on how to select appropriate

parameters for identifying lead-based

paint hazards. Based on this analysis,

the Agency concluded, for the following

reasons, that the hazard standards

should be based on a set of parameters

identified by balancing the costs of

reducing exposures to lead-based paint

hazards with the benefits of avoiding

adverse human health effects.

First, the identification of lead-based

paint hazards is linked with hazard

reduction in many provisions of Title X,

including sections 1011(e)(8) and (9),

1012(a) and (e), and TSCA section

401(8) and (13). This linkage suggests

that measures taken to reduce hazards

should be consistent with the risks

presented. The Senate Report,

recognizing that many property owners

would implement interim controls to

respond to lead-based paint hazards,

states that ‘‘interim measures should be

commensurate with the degrees of risk

reported by the risk assessment’’ (p.

115). The Report is most explicit in its

discussion of lead-based paint hazard

reduction in Federally assisted and

insured housing, where it states that

‘‘the response would correspond to the

degree of danger and the benefit to be

achieved’’ (p. 117). Cost-benefit

balancing is a reasonable method that

can be used to assist EPA in setting

hazard standards that would promote

control activities that are commensurate

with risk.

Second, cost-benefit balancing is a

useful method to examine the potential

for adverse effects, the resource

allocation that should be associated

with reducing that potential, and

methods of public protection when the

available scientific evidence shows

there is a wide range of uncertainty in

the risks that may be associated with

any particular levels. The Senate Report

recognized that there is a wide range of

responses applicable to lead-based paint

and paint hazards depending on the

degree of risk and the likelihood of risk

reduction that could occur from any

particular action. In particular, property

owners can choose to reduce hazards

through ‘‘abatement’’ (permanent

elimination of hazards) or ‘‘interim

measures’’ (temporary exposure

reduction). See TSCA sections 401(1),

(8), and (13). The Senate Report at 113-

115 specifically refers to this wide range

of applicable responses and the need to

consider measures commensurate with

the risk. The Senate Report at 113 states

that housing owners

will choose to abate or partially abate when

they determine that it is cost effective for

them to permanently eliminate the source of

hazards.

Further, the Senate Report at 115 states

that interim measures

should be commensurate with the degree

of risk reported by the risk assessment. Thus,

where moderately elevated dust levels exist

but there is little deterioration in the paint,

an appropriate interim response might be

limited to supercleaning leaded surfaces.

Where children are present and paint is

peeling, interim controls might require a

more substantial effort and expense to

prevent exposure from paint chips and dust.

Given these standards, EPA believes

that it is a reasonable interpretation of

TSCA section 403 to identify the

conditions that constitute lead-based

paint hazards by considering the weight

of evidence on the range of

environmental lead levels that would

result in particular blood lead levels, the

adverse effects associated with those

blood-lead concentrations, and potential

ranges of risk reduction (reductions in

blood-lead concentration) that would

result from eliminating or controlling

the levels.

Several purposes of Title X also

support the use of cost-benefit balancing

for establishing the hazard standards.

According to section 1003(2) of Title X,

one purpose of the statute is ‘‘to

implement, on a priority basis, a broad

program to evaluate and reduce leadbased paint hazards in the Nation’s

housing stock.’’ The concept of prioritysetting inherently recognizes that

resources are scarce, and that scarce

resources are most effectively employed

when decision-makers apply them to

the worst problems first. To develop

standards that are consistent with the

need to set priorities, EPA factored in

the resources needed to reduce risks, the

benefits of controlling lead-based paint

hazards, and data on the presence of

lead in residential paint, dust, and soil

when selecting the proposed standards.

Cost-benefit analysis is a principal

analytical tool available to the Agency

to measure the effectiveness of using

resources to reduce human health risks.

Section 1003(3) of Title X also states

that a purpose of the statute is ‘‘to

encourage effective action to prevent

childhood lead poisoning by

establishing a workable framework for

lead-based paint hazard evaluation and

reduction. . . .’’ In developing today’s

proposal, EPA interprets the term

‘‘workable’’ to mean practical, usable,

and realistic. First, a workable

framework must be practical; that is, it

should promote priority-setting,

focusing resources on the most

significant risks. Overly stringent

standards that result in the

identification of lead-based paint

hazards in large segments of the housing

stock would not be practical because

they would not provide guidance to

decision-makers on where to focus

resources.

Second, the standards must be usable

by the intended audience. Risk assessors

must be able to use the standards as a

tool to evaluate properties quickly at a

modest cost. The standards should not

require extensive and costly

environmental measurement. The

meaning of the standards must be

sufficiently simple for risk assessors to

explain and property owners, residents,

and other decision-makers to

understand the significance of the

findings of a risk assessment.

Third, for a framework to be

workable, it needs to be based on

realistic goals, goals that are achievable

with available resources and feasible

with available technology. The

standards for identifying lead-based

paint hazards, therefore, need to

recognize resource and technological

constraints. These standards, the

primary function of which is to provide

guidance and advice, risk being ignored

by their intended audience and having

no value if they are not practical, usable,

and realistic.

Section 1003(3) also refers to the Title

X purpose of ‘‘. . . ending the current

confusion over reasonable standards of

care.’’ EPA interprets a ‘‘reasonable’’

standard to be one that requires exercise

of judgment to balance the probability

that harm will occur, and the magnitude

and severity of that harm, against the

adverse social and economic impacts on

society of the action taken to reduce the

harm. The reasonableness standard

becomes more judgmental in the case of

health risks of lead where, as a practical

matter, all the scientific evidence is

uncertain to some degree and EPA is

forced to deal in probabilities that can

vary over extreme ranges. Therefore, in

evaluating a reasonable standard of care
30314 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

under Title X, EPA will consider the

various relationships among such

factors as toxicity, exposure, the

effectiveness of interventions, and the

cost of interventions.

EPA, further, believes that

consideration of cost is consistent with

the establishment of these lead

standards. The purpose of the lead

hazard standards is to protect the public

health. To do this within the framework

of Title X, however, requires the

expenditure of scarce public and private

resources. Ensuring that these resources

are used in a manner that maximizes

health protection means that EPA

should establish lead hazard standards

that direct resources to where the

threats to public health are the greatest.

EPA recognizes there are different ways

in which the TSCA section 403

standards may be interpreted and,

specifically, requests comment on

whether it is appropriate for the Agency

to use the cost-benefit analysis to

develop the hazard standards for this

rule.

3. Policy basis for the standards—a.

Dust-lead and soil-lead levels of

concern. To implement its decision to

treat the dust-lead and soil-lead levels of

concern as risk communication tools,

EPA is proposing that the soil and dust

levels of concern should be associated

with a blood-lead concentration of

concern and a child’s probability of

exceeding that blood-lead concentration

(exceedance probability). As noted

previously, EPA is proposing to

establish a soil-lead level of concern for

use in guidance and not to include it in

the proposed regulation.

EPA used blood-lead concentration as

the measure of human health risk,

because it is the most widely used index

of human lead exposure and risk. By

exceedance probability, EPA means an

individual child’s risk or probability of

having a blood-lead concentration that

equals or exceeds a specified

concentration. For example, if the

blood-lead concentration of concern is

10 μg/dl, an exceedance probability of

one percent means that a child has a one

percent chance of having a blood-lead

concentration that equals or exceeds 10

μg/dl.

An exceedance probability is needed

because the relationship between lead

in the environment and blood-lead

concentration is characterized by a great

deal of variability due to several factors,

including differences among children in

behavior and nutrition. The

measurement of lead in the environment

and in blood is also subject to a

significant degree of variation. It is not

possible, therefore, to link a specific

level of lead in the environment (e.g.,

soil) to a specific blood-lead

concentration with absolute certainty.

Rather, a specific level of lead in the

environment is associated with a

distribution of blood-lead

concentrations.

The distribution, which can be

thought of as a curve drawn on a graph,

represents the range of blood-lead

concentrations and the relative

probability that each blood-lead

concentration would actually occur. A

distribution is described by three

parameters: the form (i.e., shape) of the

distribution (e.g., normal distribution or

‘‘bell’’ curve, log normal distribution); a

measure of central tendency (e.g., mean

or average); and a measure of variability

or spread (e.g., standard deviation)

around the measure of central tendency.

With these three parameters, the

probability of exceeding any blood-lead

concentration can be calculated. For

further discussion of standard deviation,

please see Matlack, Statistics for Public

Policy and Management (Ref. 18).

b. Dust-lead and soil-lead hazard

standards. Having presented its

rationale, above, for using cost-benefit

balancing to help develop the proposed

dust and soil-lead hazard standards,

EPA now explains its intent to use costbenefit balancing in the hazard

standard-setting process.

It is important to note that the

Agency’s analyses for dust and soil

began with an examination of

quantitative estimates based on various

modeling techniques. These techniques

allow the Agency to arrive at a range of

options on which the Agency exercises

its administrative judgment. Thus, the

quantitative modeling is used as a tool

to derive the boundaries of the Agency’s

inquiry, not as the sole basis for

decisions.

Furthermore, the Agency wishes to

note that it employed a normative

analysis to support the selection of the

dust-lead and soil-lead hazard

standards. A normative analysis

estimates costs and benefits based on

the assumption that individuals will

make perfectly rationale decisions in

response to the standards. That is, all

individuals who should conduct risk

assessments will do so, and all

individuals will undertake appropriate

interventions in response to hazards

identified by the risk assessment. This

normative analysis also assumes that no

action is being taken in the absence of

the standards. In reality, hazards will

not be identified in many homes

because risk assessments will not be

performed. Even if hazards are

identified, interventions may not be

performed or interventions different

from those assumed in the analysis may

be performed. In addition, risk

assessments and hazard control

interventions are currently being

conducted.

EPA used a normative analysis for

two reasons. First, as a practical matter,

it is difficult, if not impossible, to

estimate expected costs and benefits

associated with the standards. Such

estimates would require data on the

current level of risk assessment and

abatement, which is not available, and

the Agency to predict how property

owners and other decision-makers will

respond to the standards. Second, the

objective of the analysis is to provide

estimates that allow Agency decisionmakers to compare costs and benefits.

Although the normative analysis is

likely to overestimate actual costs and

benefits, EPA believes that the relative

balance of costs and benefits estimated

by the analysis is unlikely to be very

different from the relative balance of

actual costs and benefits. Therefore, the

Agency can use these estimates to

evaluate various options for the dust

and soil standards.

With respect to the paint component

of the proposed regulation, data

limitations prevented EPA from

quantifying the costs and benefits of the

options considered in this proposal.

Data that definitively relate deteriorated

paint to blood-lead concentration are

not available, preventing the Agency

from estimating the benefits of these

options. EPA could not estimate the

costs of these options because the

Agency’s decision regarding

deteriorated lead-based paint focused on

the area of deterioration on individual

components whereas the available data

provide information on the amount of

deteriorated paint in an entire

residence. Consequently, EPA’s

decisions with respect to the options for

the paint component involve a more

qualitative judgment on the part of the

Agency.

As part of its economic analysis of the

proposed rule, EPA developed estimates

of the costs and benefits of repairing or

abating deteriorated lead-based paint.

The preamble presents these estimates

in Unit X. The data limitations

identified above as well as other

analytical constraints described in Unit

X, however, restrict the usefulness and

call into question the reliability of these

estimates in characterizing the proposed

regulatory standards for paint.

While Title X provides no guidance

on how to undertake cost-benefit

balancing, the legislative history of

TSCA provides a useful and pertinent

explanation of the concept. The House

Report on TSCA (H. Rep. 1341, 94th

Cong., 2nd Sess. at 13-15, 32)
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30315

acknowledges that cost-benefit

balancing for regulation is not precise

but, instead, requires the exercise of

judgment by the decision-maker. It

involves the balancing of the probability

that harm will occur, and the magnitude

and severity of that harm, against the

cost of the proposed action to reduce

that harm. In other words, cost-benefit

balancing involves a weighing of the

risks to be reduced by response actions

and the costs of these actions.

The TSCA House Report emphasizes

that cost-benefit balancing does not

require a formal quantitative analysis

under which a monetary value is

assigned to risks that may be reduced by

regulation or the costs to society. This

is because precise values often cannot

be assigned to such risks and costs.

Accordingly, cost-benefit balancing is

appropriately used to establish a range

of options for the hazard standards.

Using this approach, the Agency then

selects its preferred options based on

consideration of relevant factors,

including the weight of the evidence of

harm, assumptions and tools that

underlie EPA’s analysis, as well as other

factors, including health protectiveness

and total costs.

Cost-benefit balancing involves a twostep process: evaluation of risk and riskreduction (i.e., benefit), followed by

consideration of the resources needed to

achieve varying degrees of risk

reduction. Below, EPA explains first the

concept of evaluating risk and risk

reduction, then the concept of

evaluating how to balance risk

reduction (benefit) with costs.

With respect to risk, the TSCA House

Report states that: ‘‘. . .risk is measured

not solely by the probability of harm,

but instead includes elements both of

probability of harm and severity of harm

and those elements may vary in relation

to each other’’ [emphasis added].

Determining risk becomes more

judgmental in the case of health and

environmental risks covered by EPA in

cases where the scientific evidence on

hazard and exposure contains a high

degree of uncertainty and variability

encompassing numerous relationships

among elements of risk, including

consideration of the severity and

probability of harm resulting from the

different types of exposure that may

occur. Because of the uncertainty in all

of these estimates, there are generally no

definitive answers as to what the risk

may be. Therefore, in evaluating risk,

EPA considers various factors, including

the strength of the evidence on toxicity

(for example, actual cases of harm from

epidemiology studies or results of highdose animal tests), the type and

magnitude of effects that are predicted

to occur (for example, severe effects or

more subtle ones), and estimates of the

numbers of individuals exposed and the

levels of exposure based on mechanistic

and statistical models.

Once the risk is evaluated, with the

attendant uncertainties in hazard

evaluation and the variations in

exposure probability, the next step is to

consider the costs of the regulatory

action. The probability and severity of

harm (in this case, a range of children’s

health effects) are weighed against the

impact of any action EPA proposes to

take to evaluate whether the costs are

commensurate with risk reduction.

There is, however, no set way to apply

EPA’s chosen approach for this

rulemaking to balancing costs and risk

reduction. To illustrate this point, the

Agency provides the following

examples. Where standards would

require the high expenditure of

resources, the level of risk reduction

(considering both the toxicity of lead

and the probabilities of exposure) and

the strength of evidence should be

correspondingly high. On the other

hand, if the costs of standards are

relatively low, the level of risk

reduction and the strength of the

evidence could be less compelling.

Today’s proposed rule takes this

balancing into account in proposing

both soil and dust hazard standards.

The determination on soil standards

considers the fact that relatively high

costs would be incurred to abate

residential soils. Consequently, under a

cost-benefit balancing concept, before

selecting an option associated with high

costs, EPA would want a greater

measure of confidence that the standard

would result in a higher level of risk

reduction. Because the cost of reducing

risk from residential dust is relatively

low, EPA could select a dust-lead

hazard standard that would not result in

as much risk reduction.

Finally, EPA believes that this type of

analysis is an appropriate way to deal

with the problems caused by lead in

paint and residential dust and soil. Lead

is a substance for which there is no clear

evidence that there is a level of

exposure below which there is no risk.

It is clear, however, that there is some

level of lead where the use of scarce

resources to reduce exposure to lead is

warranted. EPA recognizes that

resources needed to address risks from

lead-based paint hazards are limited and

would like to set standards to target

responses to these hazards so that the

highest risks will be addressed first. In

contrast, spending valuable resources

engaging in cleanup activities to achieve

little or no reduction in risk would not

be a reasonable approach.

B. Technical Analyses

To support the development of dust

and soil lead levels of concern, as well

as for the hazard standards, EPA

requires a tool to relate lead in the

environment to blood-lead

concentration. As will be further

explained below, EPA has chosen two

types of models to be used for this

purpose: a mechanistic model and a

statistical model based on empirical

data. A mechanistic model simulates the

human body’s response to lead that is

ingested or inhaled. Because biological

processes that mechanistic models are

designed to simulate are not completely

understood, these models are typically

limited in their predictive capability.

The components of the processes that

are understood have to be simplified

and digested into a series of

mathematical equations resulting in

another source of error. The data that

are used as inputs into these models

may not be truly representative and may

contain gaps.

Alternatively, EPA could use

observational data to estimate the

relationship between environmental

lead and blood lead. Two national data

sets are available to the Agency. EPA

has national blood-lead data from Phase

2 of the third National Health and

Nutrition Examination Survey

(NHANES III) (Ref. 6) and national data

on levels of lead in dust and soil and

condition of paint from the National

Survey of Lead-Based Paint in Housing,

conducted from 1989-1990 by the U.S.

Department of Housing and Urban

Development (Ref. 19). These data sets,

however, are not linked. That is, there

is no direct observation between bloodlead in NHANES and the environmental

levels in the HUD survey. Therefore,

these data sets cannot be used in

combination to estimate the relationship

between lead in dust and soil and

blood-lead concentration.

In light of limited data and imperfect

models, the Agency cannot rely on any

single approach to specify the true

relationship between lead in dust and

soil and blood lead. EPA, therefore,

used several tools to derive differing

estimates of the relationship. The

mechanistic model used for the various

analyses in this proposed rule is the

Agency’s Integrated Environmental

Uptake and Biokinetic (IEUBK) model.

EPA also conducted several analyses for

this rule using data from the Rochester

Lead-in-Dust study, which contains data

for children’s blood-lead concentrations

and dust and soil-lead levels in their

environment (Ref. 20). These tools will

be discussed further below in the

sections where they are used.
30316 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

The Agency wishes to note that the

differing estimates of the relationship

between environmental lead and bloodlead concentration do not bound the

range of options available to EPA for the

proposed rule. The true relationship

between blood-lead and dust and soillead could be stronger or weaker than

the estimates used in this proposed rule.

1. Dust-lead and soil-lead levels of

concern. This section of the preamble

presents the Agency’s rationale for its

choice of 10 μg/dl as the blood-lead

concentration of concern, and for its

choice of the appropriate exceedance

probability of one to five percent. EPA

then explains how it identified the dust

and soil-lead levels at which the Agency

reasonably expects an individual child

would have a probability of

approximately one to five percent of

having a blood-lead concentration equal

to or exceeding 10 μg/dl.

a. Blood-lead concentration of

concern. EPA has determined that the

weight of scientific evidence, as

discussed below, shows that 10 μg/dl is

a reasonable level of concern for

childhood blood lead under the

applicable statutory standard of ‘‘poses

a threat.’’ EPA disagrees that the term

‘‘poses a threat’’ suggests that the lead

levels of concern should be based on

any non-zero risk (zero-risk basis). Zero

risk equates to a blood-lead

concentration of zero because there is

no known health effects threshold for

lead. EPA, however, proposes to reject

the zero risk basis for dust and soil-lead

levels of concern for several reasons.

First, although some data suggest that

adverse health effects occur at the

lowest observed levels, only a small

number of children with such low

blood-lead concentrations have been

examined. Furthermore, the health

effects at the lowest levels of exposure

are small and subtle, making it difficult

to associate effects with any single

factor. Therefore, there is insufficient

evidence at these lowest levels to state

that there is a level of risk that warrants

national public concern. Second,

standards based on zero risk would not

serve as a useful communication tool

because lead is ubiquitous in the

environment and there is no practical

way to eliminate exposure. Third, EPA

believes that zero risk-based standards

were not the intent of Congress. If any

level of lead in dust and soil constitutes

contamination or a hazard, there would

be no need for EPA to identify these

conditions.

Having rejected zero as the blood-lead

concentration basis for dust and soillead levels of concern, EPA had to

identify an alternative blood-lead

concentration. Numerous human

epidemiological and clinical studies, as

well as animal toxicological and in vitro

studies indicate clear signs of toxicity

across a wide range of exposures. While

the results of human studies are not

uniform, and there is inevitably

uncertainty regarding the precise nature

and persistence of effects at low levels,

these studies are predominately similar

in their overall findings. Furthermore,

there is consensus within the expert

medical community that even low levels

of lead exposure warrant public health

concern.

As listed below, numerous health

effects, many of them neurological, have

been related to blood-lead

concentrations down to levels of at least

10-15 μg/dl:

1. Altered synthesis of heme as

indicated by inhibitions in the enzymes

delta-aminolevulinate dehydrase,

pyrimidine-5-nucleotidase, and red

blood cell ATPase, and accumulations

of the heme precursor, erythrocyte

protoporphyrin in red blood cells. (e.g.,

Refs. 21-29).

2. Reduction in vitamin D hormone

synthesis in children (e.g., Ref. 30).

3. Alterations of brain electrical

activity in children (e.g, Refs. 31-37).

4. Altered nerve conduction in

auditory pathway and decreased hearing

acuity in children (e.g., Refs. 34 and 38).

5. Delays in cognitive development

and slower sensory-motor development

during infancy (e.g., Refs. 39-41).

6. Other neurobehavioral impacts

(e.g., IQ deficits) in children (e.g., Refs.

42-48).

7. Decreased stature or growth in

young children (e.g., Refs. 49-51).

8. Decreased ability to maintain

steady posture in children (e.g., Ref. 52).

9. Reduced gestational age and

reduced weight at birth, associated with

maternal and cord blood-lead

concentrations (e.g., Refs. 53 and 54).

10. Increased blood pressure in adults

(e.g., Refs. 5 and 55).

While it is possible that some of these

effects are reversible (e.g., altered heme

synthesis), or have unclear medical or

functional implications (e.g., altered

brain electrical activity), the Agency

believes that the collective impact of

these effects on diverse physiological

functions and organ systems of young

children with blood-lead concentrations

as low as 10 μg/dl are clearly adverse.

This conclusion is consistent with the

findings of other EPA reports, EPA’s

Clean Air Scientific Advisory

Committee (CASAC), the Centers for

Disease Control and Prevention in their

1991 statement Preventing Lead

Poisoning in Young Children, and the

National Academy of Sciences in their

1993 report Measuring Lead Exposure in

Infants, Children, and Other Sensitive

Populations.

U.S. EPA’s 1986 Air Quality Criteria

Document for Lead (Ref. 56) concluded

that for children: (1) The collective

impact of the effects at blood-lead

concentrations above 15 μg/dl

represents a clear pattern of adverse

effects worthy of avoidance; (2) at levels

of 10-15 μg/dl there appears to be a

convergence of evidence of leadinduced interference with a diverse set

of physiological functions and

processes, particularly evident in

several independent studies showing

impaired neurobehavioral function and

development; and (3) the available data

do not indicate a clear threshold at 10-

15 μg/dl, but rather suggest a continuum

of health risks approaching the lowest

levels measured. The health effects

below this range are less well

substantiated.

In reviewing the information

presented in the 1986 Air Quality

Criteria Document and Addendum,

EPA’s CASAC concluded various effects

starting at blood-lead concentrations

around 10-15 μg/dl or even lower in

young children ‘‘may be argued as

becoming biomedically adverse’’ (Ref.

57). After reviewing the 1990

Supplement to the Addendum (Ref. 58),

as well as a staff position paper of EPA’s

Office of Air Quality Planning and

Standards (Ref. 59), CASAC concluded

that blood-lead concentrations above 10

μg/dl clearly warrant avoidance,

especially for the development of

adverse human health effects in

sensitive populations. The Committee

concluded ‘‘that EPA should seek to

establish an air standard which

minimizes the number of children with

blood-lead concentrations above a target

value of 10 μg/dl. In reaching this

conclusion, the Committee recognizes

that there is no discernible threshold for

several lead effects and that biological

changes can occur at lower levels’’ (p.

1, Ref. 57).

In their 1991 Statement, CDC revised

the action level for the lead screening

and intervention program from 25 μg/dl

set in 1985 to 10 μg/dl and stated that

‘‘the scientific evidence showing that

some adverse effects occur at blood-lead

concentrations at least as low as 10 μg/

dl in children has become so

overwhelming and compelling that it

must be a major force in determining

how we approach childhood lead

exposure’’ (p. 1, Ref. 2). While CDC does

not specify which of the many effects

associated with low-level lead exposure

are individually considered adverse, the

following discussion indicates that the

collective impact of the different effects
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30317

poses risks that should be avoided (pp.

9-10, Ref. 2):

Blood-lead concentrations as low as

10 μg/dl, which do not cause distinctive

symptoms, are associated with

decreased intelligence and impaired

neurobehavioral development (Refs. 60-

61). Many other effects begin at these

low blood-lead concentrations,

including decreased stature or growth

(Refs. 49, 50, and 51), decreased hearing

acuity (Ref. 38), and decreased ability to

maintain a steady posture (Ref. 52).

Lead’s impairment of the synthesis of

the active metabolite 1,25-(OH)2 vitamin

D is detectable at blood-lead

concentrations of 10-15 μg/dl. Maternal

and cord blood-lead concentrations of

10-15 μg/dl appear to be associated with

reduced gestational age and reduced

weight at birth (Ref. 62). Although

researchers have not yet completely

defined the impact of blood-lead

concentrations <10 μg/dl on central

nervous system function, it may be that

even these levels are associated with

adverse effects that will be clearer with

more refined research.

CDC recommends that community-wide

interventions (e.g., outreach and

education, surveillance) should be

considered by appropriate agencies if

many children have blood-lead

concentrations that equal or exceed 10

μg/dl (Ref. 2).

The National Academy of Sciences

agreed with the CDC assessment of the

existing studies and data, noting that

blood-lead concentrations around 10 μg/

dl are associated with disturbances in

early physical and mental growth and in

later intellectual functioning and

academic achievement (Ref. 63).

For purposes of this proposed rule,

EPA is establishing 10 μg/dl as the

blood-lead concentration of concern.

This decision is based on EPA’s review

of the scientific evidence and earlier

Agency findings that a number of health

effects begin to manifest themselves at

blood levels of 10-15 μg/dl and that the

collective impact of these effects poses

risks that should be avoided. EPA chose

the level at the lower end of this range

to provide an adequate margin of safety.

EPA decided not to establish a level

lower than 10 μg/dl because the

evidence indicates that health effects at

lower levels of exposure are less well

substantiated, based on a limited

number of studies, a limited number of

children, and observation of subtle

molecular changes that are not currently

thought to be sufficiently significant to

warrant national concern.

b. Exceedance probability. Unlike

EPA’s choice of the blood-lead

concentration, where there is a body of

scientific literature to guide the

decision-making process, there is no

scientific evidence to assist the Agency

in selecting the appropriate exceedance

probability. EPA’s decision for this

value is, instead, guided by judgment

about levels of risk that are achievable

and consistent with the statutory

criteria.

EPA looked at several options for an

appropriate exceedance probability. The

Agency rejected the lowest possible

probability, which is zero, because it is

unachievable. The Agency’s risk

analysis demonstrated that a very small

percentage of children would have

blood-lead concentrations equaling or

exceeding 10 μg/dl even if there were no

lead-based paint and lead-contaminated

soil and dust, because other sources of

exposure (e.g., air, water, diet, and

background levels of lead) remain (Ref.

1).

At the other end of the range

considered by EPA was an exceedance

probability of 10 percent. With this

distribution of risk, a child would have

a 1.6 percent chance of having a bloodlead concentration exceeding 15 μg/dl

and a less than one percent chance of

having a blood-lead concentration

exceeding 20 μg/dl, the level at which

CDC recommends medical intervention.

The Agency rejected this probability as

presenting risks above the threshold that

the dust and soil-lead levels of concern

are supposed to communicate.

Consequently, the Agency determined

that the range of probabilities between

one and five percent would be

consistent with the statutory criterion

for level of concern, ‘‘pose a threat.’’

Given the data and analytical tools

available to EPA, the Agency

determined that, as a practical matter,

one percent is not distinguishable from

five percent. This overlap is due to the

uncertainty and variability related to

any effort to associate levels of lead in

the environment to blood-lead

concentrations and limited data.

As a result of exposure to levels of

lead in dust and soil associated with

these probabilities, a child would have

a relatively small chance of having a

blood-lead concentration equal to or

exceeding 10 μg/dl. The Agency

considers this small chance of

exceeding the blood-lead concentration

of concern to be consistent with ‘‘pose

a threat.’’ Consequently, EPA is

proposing to include in guidance a level

of concern where the levels of lead in

dust and soil are associated with a one

to five percent probability that a child

would have a blood-lead concentration

equal to or exceeding 10 μg/dl.

In seeking comment on this decision,

EPA is interested in obtaining any

information that would provide

additional support for its decision or

support the selection of another option.

c. Characterizing individual risk. EPA

identified several alternative tools to

support the development of the dust

and soil-lead levels of concern: (1) The

Agency’s IEUBK model; (2) a

‘‘multimedia’’ model based on the data

from the Rochester Lead-in-Dust study;

and (3) a performance characteristics

analysis of the Rochester data. The

IEUBK model was not used to examine

dust lead levels because the model uses

dust-lead concentration and, as

explained in Unit V. of this preamble,

EPA has decided to propose a loading

standard for dust. Conversely, the

multimedia model based on the

Rochester data was used only for dust.

It uses dripline soil lead measurements

rather than yard-wide average and,

therefore, EPA chose not to use it to

examine the levels of concern for lead

in soil in this proposal. EPA used the

performance characteristic analysis of

the Rochester data for both the dust and

soil-lead levels of concern.

d. Dust analyses. EPA conducted two

analyses to support development of the

dust-lead level of concern: an analysis

that used the multimedia model based

on the Rochester data and a

performance characteristics analysis of

the Rochester data. The multimedia

model was developed specifically to

support the development of options for

this proposed rule. It is a regression

model that relates environmental lead

levels in dust and soil observed at a

residence to the blood-lead

concentration measured for a child

living at the residence. Regression

analysis is a statistical technique used to

estimate the dependence of one variable

upon others, in this case the

dependence of a child’s blood lead level

on the environmental lead levels

measured in and around his or her

home. For a detailed discussion of

regression analysis please see Matlack,

Statistics for Public Policy and

Management (Ref. 18).

EPA decided to use the data from the

Rochester Lead-in-Dust Study as the

basis for the multimedia model for the

following reasons: (1) Dust on all

surfaces that are being considered for

the TSCA section 403 standards were

measured for lead in the Rochester

Study; (2) the Rochester Study includes

dust-lead loadings from wipe sampling

and the TSCA section 403 dust standard

is expected to be based on dust-lead

loading from wipe sampling; and, (3)

the selection of homes and children in

the Rochester Study, although targeted,

was more random and more

representative of a general population
30318 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

than is the case with other recent

epidemiological studies of lead

exposure in urban environments where

lead-based paint is a significant source

of lead in dust and soil.

The multimedia model can be used to

predict an average blood-lead

concentration for an individual child

who is exposed to a given set of

environmental-lead levels. A constant

empirical estimate of variability is

applied to this average to estimate a

distribution of blood-lead

concentrations. In statistical

terminology, this estimate of variability

is referred to as the geometric standard

deviation (GSD), a type of ‘‘standard

deviation’’ that is used for log normal

distributions. The GSD in this case

characterizes biological and behavioral

variability in blood lead for a given set

of environmental exposures. The

predicted distribution can then be used

to estimate the probability of a child

exceeding a specified blood-lead

concentration for a given level of

environmental exposure.

Because, in this case, EPA was

interested in determining the

environmental-lead levels that would

result in a one to five percent

probability of an individual having a

blood-lead concentration equal to or

exceeding 10 μg/dl, the Agency started

with the specified range of probabilities

of a child having a blood-lead

concentration equal to or exceeding 10

μg/dl and calculated the level of lead in

dust needed to predict this distribution.

The Agency selected a GSD of 1.6 for

use in the multimedia model, consistent

with the default value used in the

IEUBK model. This value was based

upon the GSDs calculated for various

sites after differences in site-specific

dust and soil-lead measurements were

removed. In this way, the GSD reflects

the behavioral and biological variability

in children as well as repeat sampling

variability, sample location variability,

and analytical error. Because EPA is

using the multimedia model to predict

a blood lead distribution for a fixed

level of lead in the environment, it is

appropriate to use a GSD that accounts

for these sources of variability but not

differences in environmental lead

levels. Median GSDs, weighted by

sample size within subgroups defined

by age, dust-lead concentration, and

soil-lead concentration were estimated

as 1.69 for Midvale, Utah, 1.53 for the

Baltimore data from the Urban Soil Lead

Demonstration Project, and 1.60 for

Butte, Montana (see section 4.2.2,

Guidance Manual for the Integrated

Exposure Uptake Biokinetic Model for

Lead in Children). Given these results,

the Agency believes that 1.6 is a

reasonable value for the GSD in this

application.

EPA presents a more detailed

description of the multimedia model in

the Risk Analysis to Support Standards

for Lead in Paint, Dust, and Soil, which

can be found in the public record for

this proposal (Ref. 1).

The multimedia model yielded the

following results. The levels of lead in

dust on uncarpeted floors associated

with an individual child having from a

one to five percent chance of having a

blood-lead concentration equal to or

exceeding 10 μg/dl range from near zero

to 6.7 μg/ft2, depending on the dust-lead

loadings on window sills and the

concentration of lead in soil. The range

for dust loadings on window sills is

from near zero to 74 μg/ft2 depending on

dust-lead loadings on floors and the

concentration of lead in soil. The results

of this analysis are presented in Chapter

5 of the Agency’s risk analysis

document (Ref. 1).

These values are far below current

clearance standards in both EPA

guidance and HUD Guidelines and some

are near or below background levels.

These results depend on the model that

has been fitted to the Rochester data. If

the model changes by including

different variables or selecting a

different shape or form, the results

could be higher or lower. Therefore, an

alternative approach that does not

depend on a model was also employed

to estimate the levels of lead in dust

associated with a one to five percent

probability of a child having a bloodlead concentration equal to or exceeding

10 μg/dl.

The non-modeling approach or

performance characteristics analysis of

the Rochester data utilizes the concept

of negative predictive value (NPV),

which, in this case, is defined as the

probability of a child having a bloodlead concentration below a specified

level given that the observed

environmental lead level is below a

hypothetical standard. EPA used the

performance characteristics analysis to

estimate the dust loading on uncarpeted

floors and interior window sills that

would yield an NPV from 95 percent to

99 percent with a blood-lead

concentration equal to or exceeding 10

μg/dl. This range of NPVs is equivalent

to a one to five percent chance of having

a blood-lead concentration equal to or

exceeding 10 μg/dl.

Table 2 below illustrates how NPV is

computed. Homes in the Rochester

study are classified into four categories

according to two factors: (1) whether or

not environmental-lead levels measured

at the home were below or above the

example standard, and (2) whether or

not the home had a child with a bloodlead concentration above or below 10

μg/dl. Using the notation presented in

Table 2, the sum a + c is the number of

homes with environmental-lead levels

below an example option for the

standards. The NPV is the ratio c/(a +

c) and is the portion of these homes that

do not contain a child with a blood-lead

concentration at or above 10 μg/dl. An

NPV close to one suggests that almost

all of the children living in homes with

environmental-lead levels below the

example standards have blood-lead

concentrations less than 10 μg/dl. An

NPV close to zero suggests that very few

of the children living in homes with

environmental-lead levels below the

example standards have blood-lead

concentrations less than 10 μg/dl.

The performance characteristics

analysis yielded the following results.

For uncarpeted floors, dust-lead

loadings ranged from 50 μg/ft2 to 400

μg/ft2 depending on the dust-lead

loading on interior window sills and the

soil-lead concentration. For interior

window sills, dust-lead loadings ranged

from 100 μg/ft2 to 800 μg/ft2 depending

on the dust-lead loading on uncarpeted

floors and the soil-lead concentration.

These ranges are significantly higher

than the ranges yielded by the

multimedia approach (Ref. 64).

Table 2.—Definition of Negative Predictive Value Based on Empirical

Data from Lead Exposure Studies*

Blood-Lead Concentration Target

Level

Media Standard

Below

Media

Standard

Above

Media

Standard

At/Above 10 μg/dl a b

Below 10 μg/dl c d

*In the table above, the letter ‘‘a’’ represents

the number of children who have a blood-lead

concentration above a given blood-lead standard and who live in a residence with an environmental lead level below a standard for that

environmental medium. Letters ‘‘b,’’ ‘‘c,’’ and

‘‘d’’ represent similar counts. From these

counts the negative predictive value (the probability of a resident child having a low bloodlead concentration given that the observed

levels of lead in the environmental media are

below the standard at the residence) is calculated as c/(a + c).

There are also limitations in the use

of the performance characteristics

model. Like the multimedia model, this

approach is based on data collected

from a single city which may not be

representative of the nation and has not

been subjected to rigorous review. In

addition, the NPVs associated with

some options are based on small sample

sizes, which reduces the reliability of

the estimate. It is also important to note
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30319

that the NPV is purely descriptive and

not based on any assumptions about the

true distribution of children’s bloodlead concentrations. It merely describes

the characteristics of a given data set.

e. Soil analyses. EPA also used two

analyses to support development of the

soil-lead level of concern: an analysis

that used the IEUBK model and one that

used the performance characteristics

analysis of the Rochester data. The

IEUBK model is a simulation model that

estimates the uptake pathways of

environmental lead and the body’s

biological response to environmental

lead levels to predict a child’s body

burden of lead. The model considers

exposure (i.e., levels of lead in dust,

soil, air, water, and diet), intake (i.e.,

rates of ingestion and inhalation),

uptake (i.e., absorption in the lung and

gut), and biokinetics (i.e., movement

through the blood and tissues and

elimination). The model predicts a

geometric mean (i.e., a type of average)

blood-lead concentration for children

exposed at the specified environmental

lead levels. An assumed geometric

standard deviation (GSD) is then

applied to estimate the distribution of

blood-lead concentrations from which a

probability of exceeding a specified

blood-lead concentration can be

derived. As was the case with the

multimedia model analysis for dust, a

GSD of 1.6 was assumed for this

analysis.

EPA chose to use the IEUBK model to

support this rule because it is the

Agency’s most rigorously developed and

thoroughly reviewed model for

childhood lead exposure. This model

has historically been used in other

Agency programs and is the currently

recommended tool for site-specific

evaluations in the CERCLA (Superfund)

and RCRA corrective action programs.

Also, an earlier version of the model

was peer-reviewed and found

acceptable as a tool for setting air lead

standards by EPA’s Clean Air Science

Advisory Committee of the Science

Advisory Board (Ref. 57). The IEUBK

model was calibrated using

environmental-lead and blood-lead data

from two western communities:

Midvale, UT, a suburb of Salt Lake City

(Ref. 65), and East Helena, MT, a small

town outside of the State capitol at

Helena (Ref. 66). Subsequent

evaluations have shown that the IEUBK

model provides reasonable descriptions

of other sites, including urban sites (Ref.

67). The most current version, Version

0.99d, of the IEUBK model was used in

the TSCA section 403 risk assessment.

The IEUBK model yielded the

following results. Soil-lead

concentrations generally at or below 500

parts per million (ppm) will result in a

one to five percent probability that a

child will have a blood-lead

concentration that equals or exceeds 10

μg/dl depending on the level of lead in

dust. The results of this analysis are

presented in Chapter 5 of the Agency’s

risk analysis document (Ref. 1).

Of course, there are inherent

uncertainties in any model that

simulates extremely complex

relationships such as that between

environmental lead and blood lead. Not

all of the relevant physiological factors

are thoroughly understood and others

are necessarily simplified. Also, there is

child-to-child variability in factors

related to both exposure and biokinetic

response (e.g., hand-to-mouth activity,

nutritional status). While the IEUBK

model application attempts to address

these through selection of the GSD, it is

expected that deviations from the

predicted blood-lead distributions

would most likely manifest themselves

at the extremes, or ‘‘tails,’’ of the

distribution.

Recognizing that such uncertainties

exist, the Agency choose to also make

use of a non-modeling approach with

data from the Rochester study. A

performance characteristics analysis

was conducted, as was described earlier

for dust. The analysis yielded the

following results. Soil-lead

concentrations ranged from 200 ppm to

1,500 ppm depending on dust-lead

loadings on uncarpeted floors and

interior window sills and the

exceedance probability. The wide range

of soil-lead levels is largely the result of

a small number of data points.

2. Dust-lead and soil-lead hazard

standards. As discussed in section A of

this unit, EPA believes it is reasonable

to use cost-benefit balancing to develop

a range of viable options for the dust

and soil hazard standards. The risk

reduction achieved as a result of

interventions designed to control or

eliminate hazards constitutes the

benefits of the hazard standard. Dust

interventions reduce risk by reducing

dust-lead levels. Soil interventions

reduce risk both by reducing soil-lead

levels and by reducing lead

contamination of household dust.

To estimate benefits, the Agency built

on the analysis used to support

development of the dust and soil-lead

levels of concern. EPA used the models

that relate environmental lead to blood

lead to estimate the current or baseline

distribution of blood-lead

concentrations for young children and

the predicted blood-lead distribution

following hazard control interventions

implemented in response to the

standards. Risk reduction, quantified in

terms of avoided health effects, is

measured by looking at the change in

blood-lead distributions. EPA’s

normative economic analysis calculated

benefits by assigning a dollar value to

the avoided adverse health effects and

compared these benefits to the costs of

hazard control interventions.

Before presenting the detailed

description of the analysis, EPA wishes

to highlight two issues that the public

should consider when reviewing this

proposed regulation. First, the Agency’s

analysis estimates the benefits of

primary prevention. Primary prevention

is the term used to characterize actions

taken to protect people that have not yet

been exposed to a hazard. In this

analysis, baseline risk is the level of risk

that the Agency would expect children

to experience in the absence of lead

hazard control (i.e., risk associated with

exposure to current conditions). The

post-intervention risk is the level of risk

that children, who have had no previous

exposure to lead-based paint hazards,

are expected to experience with these

controls in place. In essence, the

analysis estimates the level of risk

prevented rather than the level reduced.

Where hazards are controlled, the

exposure to lead-based paint hazards

never occurs.

The analysis does not estimate the

benefits of secondary prevention, the

term used to characterize actions taken

to protect people already exposed to a

hazard. Primary prevention is thought to

be more effective than secondary

prevention because, with primary

prevention, children’s risk remains at

the pre-exposure level. With secondary

prevention, risk does not drop to preexposure levels because lead that is

stored in bone tissue continues to be

released into blood for some period of

time even after environmental levels

decline.

Many of the available exposure

studies focus on the impacts of

secondary prevention, relating

environmental lead to blood lead prior

to and after hazard control

interventions. Because the subjects in

these studies have had prior exposure,

the magnitude of the risk reduction is

smaller than estimated in EPA’s

analysis, which focuses on children

who have not had previous exposure.

Second, the majority of the benefits

estimated by EPA are derived from

avoided IQ point loss resulting from

prevented exposure to lead. The dollar

value placed on these benefits is a tool

to assist EPA in comparing costs and

benefits for purposes of this proposed

rule. It is not in any sense a real value

of the risk reduction or an Agency

standard for other actions. There are
30320 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

plainly many benefits that are not

measured in the analysis because EPA

lacks the tools and or data or because

some benefits are subjective in nature.

On the other hand, EPA assigns risk

reduction value to fractional losses of an

IQ point--tenths and even hundredths of

a point, and it is unclear the extent to

which such small changes affect quality

of life of a single individual. By this

combination of underestimating and

overestimating dollar values of potential

risk reduction benefits, EPA hopes to

arrive at some reasonable range of

values that can be used to inform

decision-making.

a. Estimating risk reduction. EPA’s

risk analysis that was conducted to

support this proposed rule provides a

methodology for measuring risk

reduction (i.e., declines in blood-lead

concentrations). Under this

methodology, EPA estimates the current

national distribution of blood-lead

concentrations for the population of

children ages one to two. The Agency

then uses this methodology to predict

future changes in the blood-lead

distribution resulting from the

implementation of hazard interventions

and expected changes in the nation’s

housing stock.

EPA used two models to estimate

blood-lead concentrations: the IEUBK

model and an empirical model based on

the Rochester data. The empirical model

is based on the multimedia model,

which was described earlier in this unit.

In order for the multimedia model to be

used for national estimates, it was

necessary to modify it to employ

environmental measures from the HUD

National Survey (Refs. 8-9 and 19). The

resulting modified model is termed the

empirical model. For a full explanation

of the differences between the

multimedia model and the empirical

model, please see Chapter 5 of the

Agency’s risk analysis document (Ref.

1). As noted above, the multimedia

model could not be used to support the

development of the soil-lead of concern.

The Agency is requesting comment on

the use of the empirical model to

support development of the soil-lead

hazard standard.

To estimate the national distribution

of blood-lead concentrations, EPA had

to run the empirical model with

nationally representative data on lead in

dust and soil. The Agency used the

HUD National Survey, which is

recognized as the leading source of data

on environmental lead levels in

residential environments. The design

and findings of the HUD National

Survey have been peer-reviewed and

published in several government

reports.

For each house in the National

Survey, EPA estimated the average

blood-lead concentration by using the

HUD data on dust lead and soil lead as

inputs into the empirical and IEUBK

models. EPA then applied the GSD of

1.6 to estimate a geometric mean bloodlead concentration for each home to

derive a distribution of blood-lead

concentrations for each home. An

estimate of the baseline national

distribution of blood-lead

concentrations was constructed by

aggregating the distributions from each

home using population weights based

on the 1993 American Housing Survey

(Ref. 68), adjusted to the 1997

population of children (aged 1 to 2

years). EPA then scaled the estimated

national baseline distribution using the

blood-lead data from NHANES.

EPA used the following process to

estimate the national blood-lead

distribution associated with each option

for dust and soil hazard standards. The

soil and dust levels for each home in the

survey were compared to a set of hazard

standard options for dust and soil. For

each set of options, the dust-lead level

was adjusted down to reflect

implementation of a dust control

intervention if the dust-lead level

exceeded the option for dust. If the soillead level exceeded the option for soil,

both the soil and dust lead levels were

adjusted down to reflect

implementation of a soil control

intervention. If a level did not exceed an

option, no adjustments to the data were

made. Once this comparison was made,

the adjusted data were run through both

models to obtain an estimated bloodlead concentration predicted by the

model. The GSD of 1.6 was then applied

to generate the blood-lead distribution

for each HUD survey home. The bloodlead distributions for all homes in the

survey were then aggregated using the

same weights as in the baseline analysis

described previously.

The use of the IEUBK model to

estimate the risk reduction associated

with various options for the dust-lead

hazard standard merits additional

explanation. As noted earlier, the

IEUBK model could not be used to

develop options for the dust-lead level

of concern because the dust standards

are in terms of loading and the IEUBK

model uses dust concentration as its

input. How, then, can the IEUBK model

be used to analyze options for the dustlead hazard standard? In contrast to the

dust-lead level of concern, where a

model that directly relates a dustloading value to a distribution of bloodlead concentrations is needed, analysis

of the options for the dust-lead hazard

standard requires a model to estimate

changes in the blood-lead distribution

for the population of young children.

EPA is able to do this with the IEUBK

model by using the model with the HUD

National Survey data.

The HUD National Survey data

contain both dust-lead loading and

concentration data for each home. To

establish the baseline distribution of

blood-lead concentrations, EPA used the

dust-lead concentration value for each

home as input for the IEUBK model. To

estimate the blood-lead distribution

associated with a set of hazard standard

options for dust and soil, EPA identified

the homes that would exceed the paint,

dust (loading), and/or soil standards.

For these homes, the analysis assigned

a post-intervention dust-lead

concentration based upon the postintervention soil concentration and the

presence or absence of deteriorated

paint. The analysis then used these

assigned dust-lead concentrations as

input to the IEUBK model to generate

post-intervention blood-lead

distributions for each of the homes. For

the homes where no standard was

exceeded, the measured dust-lead

concentration from the HUD survey was

used. The details of the procedure used

to assign post-intervention dust-lead

concentrations are fully explained in

Chapter 6 of the Agency’s risk analysis

document (Ref. 1). The Agency is

requesting comment on the use of this

application of the IEUBK model to

support development of a dust-lead

loading hazard standard.

While all young children could be

affected by exposure to lead, the

population of interest for this analysis

was U.S. children aged 1 to 2 years. The

selection of this age range as the

population of interest derived from the

following general observations: the

central nervous system is rapidly

developing in this age range, making it

highly susceptible to the effects of lead;

synaptic density of the frontal lobe of

the brain peaks in a child’s second year,

and synaptic development can be

disrupted or delayed as a result of lead

exposure; the existence of a relationship

between blood-lead concentration

measured at 1 to 2 years of age and IQ

scores measured later in life; blood-lead

concentration tends to peak in this age

range, due to an increased ability to

absorb lead; and, hand-to-mouth activity

is high in this age range, thereby

increasing the potential for ingesting

lead-contaminated dust, soil, and paint.

b. Estimating costs and benefits. The

normative economic impact analysis

estimates the benefits and costs

associated with a broad range of options

for hazard standards. Benefits and costs

are estimated over a 50–year time frame.
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30321

Net benefits are computed by

subtracting the costs from the benefits

for each option and discounting each to

the present using a three percent rate.

The benefits include a value for each

of three health outcomes associated

with declines in blood-lead

concentration: avoided IQ points lost;

avoided incidence of IQ below 70; and

avoided incidence of blood-lead

concentrations exceeding 20 μg/dl. The

costs include the expenditures on the

hazard control interventions

implemented by property owners and

other decision-makers in response to the

standards. Interventions include dust

cleaning, interior and exterior paint

repair and abatement, and soil

abatement.

The underlying engine of the

normative economic analysis is the

‘‘birth trigger’’ model. The chief feature

of this model is the assumption that

property owners do not undertake

hazard control actions until a young

child who could be harmed by the

hazard is present. The timing of testing

and intervention, therefore, is governed

by the birth rate. In the first year of a

model run, the model randomly assigns

the arrival of a child to some of the 284

homes in the HUD National Survey data

set. In homes where a child’s arrival is

predicted to occur, the model uses the

risk analysis methodology to estimate a

post-intervention blood-lead

distribution for that home. In the other

homes, interventions are not

undertaken, regardless of the

environmental conditions, and there is

no change from the baseline blood-lead

distribution. Using the risk analysis

methodology, the blood-lead

distributions for each home in the

survey are aggregated to develop a new

national blood-lead distribution after

the first year. The Agency compares the

post-intervention blood-lead

distribution in each year to the baseline

blood-lead distribution to compute the

reduction in blood-lead concentrations

associated with the option being

evaluated. The analysis is then repeated

for each of the following years through

year 50.

The operation of the model in each of

the subsequent years differs from the

initial year in two respects. First, the

analysis determines whether

interventions need to be repeated. For

example, paint repairs are assumed to

last 4 years, and therefore need to be

repeated to maintain their effectiveness.

Second, the weights assigned to each

home in the survey, which reflect the

proportion of the national housing stock

represented by that sample home,

change to reflect ongoing changes in the

housing stock. With each passing year,

new homes are built and old homes are

destroyed. In fact, the modernization of

the housing stock results in ‘‘natural’’

interventions as older homes that have

lead-based paint are replaced by new

homes that do not.

The analysis then converts the change

in blood-lead concentrations into the

three health endpoints: avoided lost IQ

points, avoided incidence of IQ below

70, and avoided incidence of blood-lead

concentrations above 20 μg/dl. The term

‘‘avoided’’ is the difference in health

measures between the baseline scenario

which assumes no intervention activity

and post-intervention scenarios, each of

which assumes a different combination

of lead hazard standard options and

hence intervention activities.

To estimate the economic value of

avoiding lost IQ points, the analysis

must first convert changes in blood-lead

concentration to changes in IQ. The

analysis then assigns a monetary value

to the IQ point loss by using an estimate

of the foregone lifetime income due to

IQ point loss. The computation of IQ

point loss is based on an average

decrease of 0.257 IQ points per increase

of one μg/dl in blood-lead concentration

(Ref. 48).

IQ affects income through ability,

education, and labor force participation.

The estimation procedure, therefore, has

two major steps. First the present value

of the earnings stream of an average

newborn is estimated. Second, available

economic literature was used to

estimate the percentage increase in

lifetime earnings one would expect from

a one point increase in IQ. Based on this

procedure, the analysis assigns a value

of $8,346 per IQ point lost (1995 dollars)

(Refs. 48, 69-71).

EPA’s estimate of the incidence of IQ

score less than 70 is based on results in

a paper by Wallsten and Whitfield

(1986) on the relationship between

reduced IQ scores and blood-lead

concentration (Ref. 72). The economic

value of avoiding cases of IQ less than

70 is approximated by using avoided

special education costs. As defined,

these education costs are incurred from

age 7 through age 18.

Avoided cases of blood-lead

concentration exceeding 20 μg/dl is

obtained directly by comparing the

distribution of post-intervention bloodlead concentrations with the baseline

distribution of blood-lead

concentrations. The monetary value was

approximated by using avoided

compensatory education costs. In this

case, the education costs are assumed to

be incurred from age 7 through age 9. In

addition, there are medical monitoring

and intervention costs associated with

children who have blood-lead

concentrations that exceed 20 μg/dl

(Refs. 2, 73, and 74).

Benefits accrue over time as hazard

control interventions are conducted,

reducing children’s exposure to lead in

paint, dust, and soil. All benefit

estimates are discounted to the present

using an annual rate of three percent.

Total benefits are the sum of benefits

calculated for each year or cohort of

children protected and represent the

present value of the stream of benefits

from the hazard controls.

The costs in this normative analysis

are principally the costs of conducting

interventions designed to control leadbased paint hazards. Interventions

assumed to be are conducted only in

those media (i.e., paint, dust, soil)

where hazards are identified. For

example, if lead levels in the soil exceed

the hazard standards, then the soil will

be removed and replaced with ‘‘clean’’

soil, but there will not be an interior

paint intervention in response to

elevated levels of lead in soil. Some

interventions, however, include dust

cleaning even if no dust hazard has been

identified initially because the

intervention may increase levels of lead

in dust.

For purposes of this normative

analysis, EPA identified six hazard

control interventions. These

interventions include paint repair or

abatement of interior paint and exterior

paint and a single intervention each for

soil and dust. It was assumed that

abatement of interior and exterior paint

hazards occur when deteriorated leadbased paint is extensive. Paint repair

occurs when deteriorated lead-based

paint is present but not extensive. Soil

intervention activities occur when the

soil-lead concentration exceeds the soil

standard. Dust hazard control occurs

when the floor dust-lead loading

exceeds the floor dust-lead standard, the

window sill-lead loading exceeds the

window sill dust-lead standard, or when

it is required to accompany another

intervention type, such as abatement of

interior paint or soil removal. Some of

the intervention actions result in

permanent control of lead hazards;

others need to be repeated periodically

to maintain their effectiveness.

According to the methodology, nonpermanent interventions are repeated as

necessary in a home until the child is

6 years of age.

Drawing on a variety of sources, EPA

obtained unit cost estimates, that is cost

per intervention per home, for the six

hazard control interventions identified

for the analysis (Refs. 75-79). EPA also

obtained cost estimates for hazard

evaluation activities (Refs. 80-83). The

Agency developed separate cost
30322 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

estimates for single- and multi-family

housing units, by adjusting the singlefamily unit cost estimates to reflect the

smaller size of multi-family units and

the smaller yards (per unit) of multifamily units. Table 3 below summarizes

these costs for single-family and multifamily housing.

Table 3.—Hazard Evaluation and Control Costs

(Per activity in 1995 dollars)

Activity Single-Family Multi-family (per unit)

Risk assessment 456 235

Interior paint repair 437 437

Interior paint abatement 6,587 4,687

Exterior paint repair 807 182

Exterior paint abatement 45,706 12,275

Dust cleaning 391 262

Soil removal (dripline; nonhazardous waste) 2,046 399

Soil removal (mid-yard; nonhazardous waste) 7,878 777

Soil removal (both areas; nonhazardous waste) 9,008 901

Soil removal (dripline; hazardous waste) 3,443 541

Soil removal (mid-yard; hazardous waste) 16,486 1,351

Soil removal (both areas; hazardous waste) 19,013 1,617

The costs of intervention for a specific

residence are a function of when a

residence is evaluated, the

environmental lead conditions in the

residence, and the length of time that an

intervention is effective (duration). The

arrival of a child determines when a

hazard evaluation will be conducted.

The choice of intervention activities

depends on the environmental lead

conditions in each medium. The

frequency with which interventions

need to be repeated depends on the

duration of the intervention. Costs for a

residence accrue over time as

interventions are repeated.

For example, paint abatement is

assumed to have a duration of 20 years.

Therefore, if post-intervention

conditions are to be maintained because

a child under age 6 is present, paint

abatement is assumed to be repeated 20

years after the initial intervention, and

again 40 years after the initial paint

abatement. Costs incurred after the first

year are discounted back to the present

using an annual discount rate of three

percent. The total cost estimate is the

sum of the discounted cost of hazard

controls conducted each year.

In estimating costs of each hazard

standard option, the model assumes that

either a lead hazard screen (for singlefamily units without deteriorated leadbased paint) or a risk assessment (all

other units) is performed. Testing is

done at the time the arrival of a child

is expected and testing is not repeated

for a unit.

The analysis’ computation of net

benefits is the difference between the

total benefits estimate and the total cost

estimate. Net benefits are an indicator of

the societal gains from hazard controls.

When interpreting the results of EPA’s

analysis, it is important to consider a

number of limitations, qualifications,

and uncertainties which affect both the

estimates of benefits and costs.

With respect to benefits, issues are

associated with the methodology used

to estimate baseline and postintervention blood-lead concentrations

and with efforts to place a monetary

value on IQ points lost. There are

important concerns with respect to the

cost analysis as well.

There are four areas of concern with

respect to the methodology used to

estimate blood-lead distributions. The

first area is associated with the HUD

National Survey data. These include

limited numbers of environmental

samples taken at each housing unit, the

sampling of only 284 houses to

represent the nation’s pre-1978 housing

stock, the age of the study, and use of

a dust collection device other than the

wipe collection method being adopted

by the TSCA section 403 proposal.

The limited number of environmental

samples can result in the

mischaracterization of dust and soillead levels at a home in the survey.

Combined with the small number of

homes sampled, mischaracterization of

dust and soil-lead levels can result in

large errors in EPA’s estimates. The age

of the study can also introduce error

because environmental-lead levels have

most likely changed since the data were

collected in 1989-1990. The use of a

dust collection device other than wipe

samples required the development of an

equation to convert these values to

wipe-equivalent values which

introduces additional error into the

estimates. The introduction of error into

the estimates contributes to overall

uncertainty in the analytical results.

A second and significant source of

uncertainty is the paucity of data with

respect to the effectiveness of hazard

control activities at reducing exposures

to lead in paint, dust, and soil. For

example, EPA’s estimate of the

effectiveness of interventions on dustlead loading is based on a limited

number of studies. The Agency’s

estimate of effectiveness of

interventions on dust-lead

concentrations is, in part, based on

limited data and, in part, based on the

best judgment of Agency scientists. Due

to the lack of data about the

effectiveness of interim controls to

reduce exposure to lead in soil, the

Agency did not include these

interventions in its analysis. The

Agency would, however, be interested

in any data the public may have

concerning the effectiveness of interim

controls that address exposure to lead in

soil.

Third, uncertainty is introduced by

using NHANES III, Phase 2 data to

calibrate the national distribution of

baseline blood-lead concentrations.

While the national representation of

NHANES III results is widely accepted,

some possible limitations in using these

data include ignoring any seasonality

effects on blood-lead concentrations and

any further decline in concentrations

that may have occurred since 1994.

Fourth, the two models are sources of

uncertainty. The limitations of the

IEUBK model were discussed

previously in this preamble. The

empirical model shares the limitations

of the multimedia model discussed

previously.

Questions regarding the value of IQ

points fall into two categories: the

relationship between blood-lead

changes and IQ point changes and the

monetary value assigned to IQ point

losses.

There are two significant limitations

involved in assigning a monetary value

to IQ point losses. The first concerns the
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30323

ability to assign value to fractional

losses of an IQ point. The analysis

assigns value to tenths and even

hundredths of an IQ point which may

not be of much significance at the

individual level. The second concerns

the value of IQ points across the range.

The analysis assigns equal value to any

IQ point change; the value of an IQ

dropping from 140 to 135 is treated the

same as an IQ dropping from 80 to 75.

In contrast, it is possible that the value

of a point may vary depending where in

the range the point is lost.

On the other hand, the Agency notes

that there are a range of other health

effects (e.g., neurological,

developmental, and others) that are not

considered in its economic analysis (see

Appendix B of the Risk Analysis to

Support Standards for Lead in Paint,

Dust, and Soil) (Ref. 1). Declines in

children’s lead exposures will also

reduce the incidence of these effects. In

addition, the economic analysis does

not include the benefits of secondary

prevention (benefits obtained by

reducing environmental and blood-lead

levels in a child already living in a

contaminated environment).

Consequently, the value associated with

avoided IQ losses in the economic

analysis can reasonably be considered to

serve as a surrogate for benefits

associated with these other effects.

Therefore, to the extent that IQ-related

benefits may be overestimated due to

the two limitations discussed above, the

non-valued benefits associated with

these other effects would tend to

mitigate such overestimates.

With respect to the estimate of costs,

there are several sources of uncertainty.

EPA’s analysis identifies only a few of

the dozens of responses that property

owners and other decision-makers could

undertake. The costs for these activities

are based on current data and could

change as competition among providers

increases or new technologies are

developed. The frequency with which

temporary measures need to be

repeated, which also affects costs,

depends on assumptions the Agency

made about the duration of the

measures’ effectiveness. These

assumptions, in turn, are based upon

judgments and extrapolations from

limited data.

c. Results. This section of the

preamble discusses the results of EPA’s

normative economic analysis of the

options for dust and soil-lead hazard

standards. Before presenting the results,

however, the Agency believes that it is

important to consider two issues when

interpreting these results.

First, undue emphasis should not be

placed on the estimates for total costs

and benefits. As noted earlier, the costs

and benefits estimated by the normative

analysis are likely to overstate the actual

costs and benefits associated with the

standards. The Agency’s analysis also

assumes that technologies and costs will

remain unchanged over the 50–year

modeling horizon. Over time, as new

technologies develop, costs may

decline. In addition, many health

benefits were not included in the

analysis because either the relationship

between exposure and the magnitude of

health effects is unknown or because the

benefits cannot be monetized.

Estimates of costs and benefits

associated with the standards are also

heavily influenced by the number of

homes estimated to exceed any standard

option. The estimated number of homes

is based on the HUD National Survey.

Although this Survey is the best

nationally representative data on

residential lead, it is characterized by

several shortcomings that were

described earlier. Among the most

significant of these is the small sample

size, which, as was noted, can introduce

errors into EPA’s estimates. For

example, only seven homes in the

Survey have soil that exceeds 2,000

ppm. Based on the age, location, and

other characteristics of these homes,

EPA estimates that these seven homes

represent 2.5 million homes nationally

which yields $9 billion in soil

intervention costs over the 50–year

model period. If HUD conducted

another survey, it is possible that only

three homes in the survey, representing

1 million homes nationally, exceed

2,000 ppm, reducing costs by 60

percent. Benefits would also be lower

because fewer children would be

protected. It is also possible that 10

homes in the survey, representing 3

million homes nationally, exceed 2,000

ppm, resulting in higher costs and

benefits.

By providing these explanations, EPA

does not intend to dismiss the costs

associated with this proposed rule.

Although the expected costs associated

with the standards are likely to be

significantly less than costs estimated

by the normative analysis, these costs

would probably still be substantial. That

is why the Agency considered costs in

evaluating options for the hazard

standards and in selecting a preferred

option. It should be remembered,

however, that these activities will

protect millions of children who will

live in abated homes over the next 50

years. As was noted earlier, EPA’s

analysis did not focus on children

already exposed to excessive levels of

lead but on children who have not been

born. In the absence of the standards

and assuming other exposures to lead

remain unchanged, approximately 10

million children are estimated to have

elevated blood-lead levels over the next

50 years. Of these, one million are

estimated to have levels that require

medical attention (Chapter 5, Ref. 83).

Second, the results obtained using

each model should be evaluated

individually to compare performance of

the options. Options should not be

compared across models. The models

represent two fundamentally different

approaches to estimating the

relationship between dust and soil-lead

and blood-lead which are not

comparable: one is mechanistic and the

other empirical. As explained above, the

two models also use different data for

input. The IEUBK model uses dustconcentration data from the HUD survey

to estimate baseline blood-lead and

assumed dust-concentrations to estimate

post-intervention blood-lead

concentrations. The empirical model

uses dust-loading data from the HUD

survey to estimate baseline blood-lead

and assumed dust-loadings to estimate

post-intervention blood-lead. This

difference is one reason why the IEUBK

model-based analysis estimates greater

risk reduction than the empirical modelbased analysis.

The objective of the analyses is to

provide EPA with a tool to compare

options in terms of relative costs and

benefits of each option, not to develop

precise absolute estimates of costs and

benefits. Despite the limitations and

uncertainties noted here and in previous

sections of this unit, EPA believes that

the results for options within each

model can be compared. The limitations

may affect the estimates of absolute

costs and benefits, but these limitations

should have similar effects on the

estimates for each option. Therefore, the

impact of the limitation and

uncertainties on the relative

performance of each option, in terms of

net benefits, estimated by each model

should be small, except where noted in

the discussion below.

Tables 4 and 5 below present the

results of the IEUBK-based analysis for

a range of dust and soil hazard standard

options. Table 4 presents the costs,

benefits, and net benefits for actions

taken in response to the specified

options for dust standards; it does not

include any soil interventions. Because

the IEUBK model does not include a

parameter for sill dust, it was used only

to analyze floor dust options. Table 5

presents figures relating to soil

standards; it does not include any dust

interventions. Neither table includes

any testing or risk assessment costs, nor

costs or benefits of paint interventions.
30324 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

Table 4.—Estimated Costs, Benefits, and Net Benefits for Dust-Lead Hazard Standard Alone (Using the IEUBK

Model)*

Floor Dust Options (μg/ft2) Number of Homes Exceeding

Option (Millions)

IEUBK Model Results (50-years; $Billion)

Costs Benefit Net Benefit

50 21 12 73 61

100 19 10 59 48

*Note: Rows may not add due to rounding. This table does not include estimated costs or benefits of paint and soil interventions, or any risk

assessment costs.

Table 5.—Estimated Costs, Benefits, and Net Benefits for Soil-Lead Hazard Standard Alone (Using the IEUBK

Model)*

Soil Option (ppm) Number of Homes Exceeding

Soil Option (Millions)

IEUBK Model Results (50-years; $Billion)

Costs Benefit Net Benefit

500 11.8 42 149 107

1,000 5.8 28 92 65

1,200 4.7 25 82 57

1,500 3.2 16 63 47

2,000 2.5 9 45 36

2,500 1.5 6 30 24

3,000 0.7 4 19 15

3,500 0.7 4 19 15

4,000 0.7 4 19 15

4,500 0.3 1 6 6

5,000 0.2 0.4 4 4

*Note: Rows may not add due to rounding. This table does not include estimated costs or benefits of paint and dust interventions, or any risk

assessment costs.

Total benefits increase as options

become increasingly stringent, ranging

from $59 billion to $73 billion for dust

and from $4 billion to $149 billion for

soil. Total benefits are a function of the

number of children (which is directly

related to the number of homes) affected

by an option and the amount of risk

reduction predicted for each child.

Furthermore benefits increase at an

increasing rate because, as dust and soillead levels decline, the number of

homes at given environmental lead

levels increases more quickly. For

example, moving from a soil standard of

5,000 ppm to 4,500 ppm increases the

number of homes exceeding the

standard from about 200,000 to about

300,000 (an increase of about 100,000

housing units), while moving from

1,000 ppm to 500 ppm increases the

number of homes exceeding the

standard from about 5.8 million to 11.8

million (an increase of about 6 million

housing units).

The rate also increases because the

changes in blood-lead concentration

predicted by the IEUBK model are

greater for a given change in dust and

soil-lead levels at lower dust and soillead levels. The increasing strength of

this relationship between environmental

lead and blood lead is sufficient to

overcome the smaller changes between

baseline and post-intervention dust and

soil-lead levels that occur as the

standard options become more

stringent. For example, the assumed

change in soil-lead level for a home that

has a soil-lead concentration of 2,500

ppm is 2,350 ppm (the assumed postintervention concentration is 150 ppm).

The assumed change for a home that has

a soil-lead concentration of 500 ppm is

only 350 ppm.

Total costs also increase as options

become increasingly stringent, ranging

from $10 billion to $12 billion for dust

and $400 million to $42 billion for soil.

Total costs are mainly a function of unit

costs (costs for a single intervention)

and the number of homes affected. For

dust, unit costs ($391 for single-family

homes and $262 for multi-family units)

are the same regardless of the standard

being evaluated. For soil, unit costs vary

depending on the part of the yard (e.g.,

dripline, mid-yard) being addressed by

the abatement and on whether the

removed soil has to be managed as

hazardous waste under regulations

found at 40 CFR part 260 to 40 CFR part

270. The unit cost is lower for lower

soil-lead levels (below 2,000 ppm)

because the removed soil does not have

to be managed as hazardous waste.

Table 3 above presents the complete

range of unit costs for soil removal. As

is the case for benefits, total costs

increase as the standard options become

more stringent because more homes

exceed each optional standard.

Unit cost should not be confused with

average cost per residence. Unit cost is

the cost per intervention per residence.

Average cost is the cost per residence

over the entire 50–year modeling

horizon and takes into account factors

such as the need to repeat interventions

(dust), averaging a range of unit costs

(soil), and discounting (both dust and

soil). Because the duration of dust

intervention effectiveness is limited if

the underlying source of lead is not

eliminated, dust cleaning may have to

be repeated, raising the average cost per

residence. Average cost for soil

abatement per residence will reflect a

mix of soil intervention costs which

vary depending on the area of the yard

addressed and the type of disposal

required. Interventions performed in the

future are discounted back to the

present. For example, the present value

of a dust cleaning performed in a singlefamily house 40 years from now would

be approximately $120 assuming a three

percent discount rate.

Because total benefits increase at a

faster rate than total costs, net benefits

also increase as options become

increasingly stringent, ranging from $41

billion to $61 billion for dust and $4

billion to $107 billion for soil. The

increase in net benefits is relatively

constant as the dust standards become

more stringent. For soil, net benefits

increase slowly from 5,000 ppm to 3,000
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30325

ppm and increase more quickly from

3,000 ppm to 500 ppm. Net benefits

increase because total benefits are

increasing at a faster rate than total

costs. This result is primarily explained

by the relationship between lead in dust

and soil and blood-lead which

strengthens as dust and soil-lead levels

decline under the IEUBK model.

Given the large number of residences

at the lower baseline dust and soil-lead

levels and the small changes in these

levels that would result from

interventions, the results of the analysis

for the more stringent options are

extremely sensitive to the assumed

relationship between dust and soil-lead

and blood lead. If the true relationship

is slightly weaker, total and net benefits

could be significantly lower.

Tables 6 and 7 below present the

results of the empirical model-based

normative analysis for a range of

possible dust and soil hazard standard

options. Table 6 presents the costs,

benefits, and net benefits for actions

taken in response to the specified

options for dust standards; it does not

include any soil interventions. Table 7

presents figures relating to soil

standards; it does not include any dust

interventions. Neither table includes

any testing or risk assessment costs, nor

costs or benefits of paint interventions.

Total benefits increase as options

become increasingly stringent, ranging

from $25 billion to $36 billion for dust

and $1 billion to $36 billion for soil. As

is the case in the IEUBK model-based

analysis, the rate at which benefits

increase rises as the stringency of the

options increase, because more homes

are affected (and more children are

protected). The rate at which benefits

increase, however, is tempered

somewhat because the relationship

between dust and soil-lead and bloodlead remains relatively constant across

the range of options considered. The

increasing number of children protected

by more stringent standards is

counterbalanced by decreasing risk

reduction predicted for children living

in homes with low dust and soil-lead

levels because the smaller changes

between baseline dust and soil-lead

levels and post-intervention levels at

lower baseline levels equate to smaller

changes in blood-lead concentration.

Costs are the same as in the IEUBKbased analysis because the models are

used only to calculate benefits.

Table 6.—Estimated Costs, Benefits, and Net Benefits for Dust-Lead Hazard Standard Alone (Using the Empirical

Model)*

Option (μg/ft2) Number of Homes Exceeding Option (Millions)Empirical Model Results (50-years; $Billion)

Floor Dust Sill Dust Costs Benefit Net Benefit

50 100 34 19 36 17

50 250 21 12 34 22

100 250 19 10 32 22

50 500 16 9 31 22

100 500 14 8 28 21

100 1,000 11 6 25 19

*Note: Rows may not add due to rounding. This table does not include estimated costs or benefits of paint and soil interventions, or any risk

assessment costs.

Table 7.—Estimated Costs, Benefits, and Net Benefits for Soil-Lead Hazard Standard Alone (Using the Empirical

Model)*

Soil Option (ppm)

Number of Homes Exceeding Soil Option (Millions)Empirical Model Results (50-years; $Billion)

Costs Benefit Net Benefit

500 11.8 42 36 -6

1,000 5.8 28 22 -6

1,200 4.7 25 19 -7

1,500 3.2 16 14 -1

2,000 2.5 9 10 2

2,500 1.5 6 5 -0.2

3,000 0.7 4 3 -1

3,500 0.7 4 3 -1

4,000 0.7 4 3 -1

4,500 0.3 1 1 1

5,000 0.2 0.4 1 0.5

*Note: Rows may not add due to rounding. This table does not include estimated costs or benefits of paint and dust interventions, or any risk

assessment costs.

Net benefits for dust range from $17

billion to $22 billion. Of the six

combinations of dust standard options

evaluated, net benefits are relatively

constant for all the combinations except

the most and least stringent. For the four

other options, benefits and costs

increase at approximately the same rate,

resulting in little change in net benefits.

Net benefits for soil range from $-7

billion to $2 billion, approaching

maximum levels near 5,000 ppm and

2,000 ppm. Below 2,000 ppm, net

benefits decrease because total benefits

increase at a slower rate than total costs.

The increased number of children

protected at more stringent standards is

offset by a smaller predicted reduction

in risk at lower environmental levels.

As stated above, the results presented

in this section show the estimated costs,

benefits, and net benefits associated

with a range of dust standards resulting

from dust interventions only and with a

range of soil standards resulting from

soil interventions only. These are the

estimates EPA used in its decisionmaking process when selecting the

preferred options for the proposed dustlead and soil-lead hazard standards.

These single-medium estimates enable

the Agency to attribute costs, benefits,

and net benefits to the interventions in
30326 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

a specific medium and allowed EPA to

compare options when developing the

media-specific standards.

The Agency, however, believes that it

would be useful for the public to

examine the estimates of costs, benefits,

and net benefits for dust and soil

interventions combined. Table 8

presents the estimates developed by the

IEUBK model-based approach for a

range of floor dust standards assuming

a sill dust standard of 250 μg/ft2 and a

soil standard of 2,000 ppm. Table 9

presents the estimates developed by the

IEUBK model-based approach for a

range of soil standards assuming a floor

dust standard of 50 μg/ft2 and a sill dust

standard of 250 μg/ft2. Table 10 presents

the estimates developed by the

empirical model-based approach for a

range of floor and window sill dust

standards assuming a soil standard of

2,000 ppm. Table 11 presents the

estimates developed by the empirical

model-based approach for a range of soil

standards assuming a floor dust

standard of 50 μg/ft2 and a sill dust

standard of 250 μg/ft2. The estimates

presented in these tables are based on

the Agency’s economic analysis.

It is important to note that the costs

and benefits for the combined dust and

soil standards in tables 8 through 11 are

less than the sum of the costs and

benefits for the corresponding mediaspecific dust and soil standards

presented in tables 4 through 7. This

difference occurs because soil

abatements are assumed to include dust

cleaning. Therefore, the estimate of

benefits derived from addressing soil

hazards alone includes some benefit

from dust cleaning, which is also

included in the estimate of dust benefits

alone. When EPA estimates the benefits

for the combined dust and soil

standards, dust cleaning that would be

triggered by either proposed standard is

only counted once. The overlapping

dust benefit, however, accounts for only

a small part of the overall benefit of the

proposed dust standard. Many homes

that exceed the proposed dust standard

do not exceed the proposed soil

standard; therefore, only a dust cleaning

would be performed in these homes and

benefits derived from establishing a dust

hazard standard would not be double

counted.

EPA wishes to reiterate that the

estimates presented in Tables 8 through

11 are presented for informational

purposes only and were not used to

guide Agency decision-making for this

proposal. The Agency requests

comments on this alternate approach for

presenting benefits, costs, and net

benefits.

Table 8.—Estimated Costs, Benefits, and Net Benefits for Dust-Lead Hazard Standard Options (Using the IEUBK

Model)*

(assumes a soil-lead hazard standard of 2,000 ppm)

Floor Dust Options (μg/ft2) Number of Homes Exceeding

Dust or Soil Option (Millions)

IEUBK Model Results (50 years; $Billion)

Costs Benefit Net Benefit

50 18 19 108 89

100 16 18 95 77

*Note: Rows may not add due to rounding. This table does not include estimated costs or benefits of paint interventions, or any risk assessment costs.

Table 9.—Estimated Costs, Benefits, and Net Benefits for Soil-Lead Hazard Standard Options (Using the IEUBK

Model)*

(assumes dust-lead hazard standards of 50 μg/ft2 for floors and 250 μg/ft2 for window sills)

Soil Option (ppm) Number of Homes Exceeding

Dust or Soil Options (Millions)

IEUBK Model Results (50 years; $Billion)

Costs Benefit Net Benefit

500 22 50 193 143

1,000 19 38 150 112

1,200 19 35 142 106

1,500 18 26 124 98

2,000 18 19 108 89

2,500 18 17 95 78

3,000 18 16 86 70

3,500 18 16 86 70

4,000 18 16 86 70

4,500 17 12 75 62

5,000 17 12 73 61

*Note: Rows may not add due to rounding. This table does not include estimated costs or benefits of paint interventions, or any risk assessment costs.

Table 10.—Estimated Costs, Benefits, and Net Benefits for Dust-Lead Hazard Standard Options (Using the

Empirical Model)*

(assumes a soil-lead hazard standard of 2,000 ppm)

Option (μg/ft2) Number of Homes

Exceeding Dust or

Soil Options (Millions)

Empirical Model Results (50 years; $Billion)

Floor Dust Sill Dust Costs Benefit Net Benefit

50 100 28 27 43 16
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30327

Table 10.—Estimated Costs, Benefits, and Net Benefits for Dust-Lead Hazard Standard Options (Using the

Empirical Model)*—Continued

(assumes a soil-lead hazard standard of 2,000 ppm)

Option (μg/ft2) Number of Homes

Exceeding Dust or

Soil Options (Millions)

Empirical Model Results (50 years; $Billion)

Floor Dust Sill Dust Costs Benefit Net Benefit

50 250 18 19 39 19

100 250 16 18 37 19

50 500 14 17 36 19

100 500 12 15 33 18

100 1,000 10 14 30 16

*Note: Rows may not add due to rounding. This table does not include estimated costs or benefits of paint interventions, or any risk assessment costs.

Table 11.—Estimated Costs, Benefits, and Net Benefits for Soil-Lead Hazard Standard Options (Using the Empirical

Model)*

(assumes dust-lead hazard standards of 50 μg/ft2 for floors and 250 μg/ft2 for window sills)

Soil Option (ppm) Number of Homes Exceeding

Dust or Soil Options (Millions)

Empirical Model Results (50 years; $Billion)

Costs Benefit Net Benefit

500 22 50 55 5

1,000 19 38 47 9

1,200 19 35 45 10

1,500 18 26 42 16

2,000 18 19 39 19

2,500 18 17 36 19

3,000 18 16 35 19

3,500 18 16 35 19

4,000 18 16 35 19

4,500 17 12 33 21

5,000 17 12 33 21

*Note: Rows may not add due to rounding. This table does not include estimated costs or benefits of paint interventions, or any risk assessment costs.

C. Agency Decisions for Dust and Soil

Standards

This section of the preamble presents

EPA’s decisions regarding the dust and

soil standards. These decisions are

based on the interpretation of, and the

conclusions drawn from, the results of

the normative analysis presented in the

previous section of the preamble. The

interpretations and conclusions are

discussed in the context of the

explanations for the specific decisions

made by the Agency. The public should

refer back to the previous section for a

more complete treatment of the

analytical results.

When considering the impacts of the

proposed standards for dust and soil,

the public should understand that

properties will be evaluated by

comparing these standards to average

dust and soil-lead levels measured by a

risk assessor, not worst-case or

maximum values. As noted in Unit VI.

of this preamble, the use of the average

value is the most reasonable approach

in the absence of specific detailed

information about exposure.

1. Dust-lead hazard. EPA has decided

to propose 50 μg/ft2 as the dust-lead

hazard standard for uncarpeted floors

and 250 μg/ft2 for interior window sills.

According to the empirical model-based

analysis, the results of which are

summarized in Table 6, four of six

combinations of options for floor and

window sill standards have net benefits

in the maximum range (i.e., $21 to $22

billion). One combination (100 μg/ft2 for

floors, 1,000 μg/ft2 for sills) provides

significantly less risk reduction relative

to cost; and one combination (50 μg/ft2

for floors, 100 μg/ft2 for sills) provides

little additional benefit but costs

increase significantly. Incremental

benefits are less than one third the

incremental costs and an additional 11

million homes would fall under the

standard. EPA, therefore, considers that

this lower standard for sills is associated

with increased costs without

commensurate attendant benefits.

Of the four combinations where net

benefits are in the maximum range, the

proposed option is the most protective

in terms of the amount of risk reduction

yielded. The other three options, though

less costly, also provide less risk

reduction. The decrease in both costs

and benefits as the combination of floor

and sill options become less stringent

are roughly the same (between $5

billion and $6 billion), resulting in little

change in net benefits.

EPA decided to propose the 50 μg/ft2

and 250 μg/ft2 standards respectively for

floors and sills because the Agency

prefers to select the most protective of

the four combinations where net

benefits are in the maximum range.

Selecting the most protective

combination of dust-lead hazard

standards is especially important when

considered in combination with the soil

and paint standards being proposed or

considered today. It will help protect

children who are exposed to lead in soil

at concentrations between the level of

concern and the hazard level by

mitigating exposure in one of the

pathways by which children are

exposed to lead in soil.

The Agency did not consider a floor

standard option less than 50 μg/ft2

because, in its risk analysis, EPA’s best

estimate is that the post intervention-
30328 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

dust lead loading is the lower of the preintervention dust-loading or 40 μg/ft2.

This is the Agency’s best estimate of

dust levels that would remain after

controlling sources of lead and

thoroughly cleaning the residence. It is

based on an analysis of data from

several abatement studies which is more

fully discussed in Chapter 6 of the

Agency’s risk analysis. In light of this

estimate, it would be impractical to set

the standard for floors lower than 40 μg/

ft2 because little or no risk reduction is

likely to be achieved for homes that had

dust-lead loadings at or below 40 μg/ft2.

If new data become available before

promulgation of the final rule that show

that even lower post-intervention dustlead loadings can be achieved, EPA

would consider establishing a more

stringent dust-lead hazard standard.

EPA’s decision on the floor standard

is further supported by the results of the

IEUBK model-based normative analysis,

summarized in Table 4, which show

that the net benefits for the proposed

floor standard are greater than those for

a less stringent standard; net benefits

estimated by this analysis increase from

$48 billion for 100 μg/ft2 to $61 billion

for the proposed 50 μg/ft2 standard. The

IEUBK model was not used to analyze

sill options because the model does not

contain a sill parameter.

EPA reiterates that this normative

cost-benefit analysis has been

undertaken for comparative purposes

only and does not mean to imply that

billions of dollars will be spent on lead

dust cleanup. These costs are put into

better perspective when it is understood

that the cost per residence of dust

cleaning is less than $600 per affected

residence over a 50–year period in 1995

dollars. In making this decision, EPA

recognizes that the proposed standard

could result in dust hazard

interventions in perhaps as many as 20

million homes. Although this is a very

large number of homes, the cost of

intensive dust cleaning is relatively low

for individual residences.

2. Dust-lead level of concern. As

noted earlier, EPA has decided not to

include a level of concern in the

proposed regulations. The Agency has

further decided not to include a dustlead level of concern that is distinct

from the dust-lead hazard standard in

accompanying guidance. This decision

is based on the fact that there is

significant overlap between the results

of the analysis for the level of concern

and the dust-lead hazard standards.

According to the performance

characteristics analysis, the range for the

level of concern is 50 to 400 μg/ft2 for

uncarpeted floors and 100 to 800 μg/ft2

for interior window sills. The hazard

standards of 50 μg/ft2 for floors and 250

μg/ft2 for sills are within these ranges.

Because it would make no sense for the

level of concern to be higher than the

hazard standard according to the

Agency’s policy framework, the level of

concern for floors could not be higher

than 50 μg/ft2, the lowest level of

concern shown by the Agency’s

analyses. EPA’s analysis therefore

suggests that the dust-lead level of

concern and the dust-lead hazard level

for floors should be the same. In light of

this result, the Agency has decided that

including a dust-lead level of concern in

guidance would serve no practical

purpose.

For window sills, it is possible to

have a level of concern as low as 100 μg/

ft2, which is lower than the hazard level.

For several reasons, however, EPA has

decided not to use this level in

guidance. First, the performance

characteristics analysis of the Rochester

data show that there is no difference in

risk between 100 μg/ft2 and 250 μg/ft2.

Due to the high correlation between lead

in dust on window sills and lead in dust

on floors and a small sample size, risk

does not change as sill dust-lead levels

vary when accounting for floor dustlead levels (Ref. 64). Second, there is a

high degree of variability in dust-lead

loading measurements, varying from

day-to-day and from location-to-location

on the same surface. In light of the small

difference in risk and the high degree of

variability in measuring dust levels,

having a level of concern for window

sills in accompanying guidance would

introduce unnecessary complexity into

EPA’s program.

3. Soil-lead level of concern. EPA is

proposing not to include a soil-lead

level of concern in the regulation. The

Agency, instead, is requesting comment

on including 400 ppm as the soil-lead

level of concern. As discussed above,

the IEUBK model indicates that soillead concentrations associated with the

risk level of concern are generally at or

below 500 ppm and the performance

characteristics analysis yielded a range

of 200 ppm to 1,500 ppm. Thus, the

range of soil-lead levels from 200 ppm

to 500 ppm is supported by the results

of both analyses. Lacking technical

criteria to select one level from this

range as the proposed soil-lead level of

concern in accompanying guidance, the

Agency determined that it should

choose 400 ppm because it is both

within this range and consistent with

the soil screening level used by EPA’s

Superfund and RCRA corrective action

programs (Ref. 84) and EPA’s current

guidance on lead-based paint hazards

(60 FR 47248). It is clear from all the

evidence that this level ‘‘poses a threat

of adverse health effects.’’ The analysis,

above, shows there is a one to five

percent chance that individual children

exposed to this soil level could have a

blood-lead level equal to or exceeding

10 μg/dl, although the Agency could not

say that adverse health effects ‘‘would

result’’ from these levels.

4. Soil-lead hazard. As explained in

Unit II. of this preamble, this public

health decision requires consideration

of the potential risks to children that

may occur at levels equal to or lower

than the chosen hazard level. At the

same time, EPA believes that

consideration of costs is necessary to

ensure that the hazard standard

promotes priority-setting and supports

the establishment of a workable national

hazard evaluation and control program.

To arrive at a proposed soil-lead hazard

level, EPA sought a level at which the

Agency had sufficient confidence in the

likelihood of harm (i.e., greater than the

level of concern) and that the cost of

abatement seemed warranted to achieve

the associated level of risk reduction.

Based on the Agency’s analysis and

judgment, EPA has decided to propose

2,000 ppm as the soil-lead hazard

standard. This decision is based on the

following reasons. First, the results of

the empirical model-based normative

analysis (summarized in Table 7) show

that net benefits are positive and near

the maximum level at 2,000 ppm. The

IEUBK normative model-based analysis

(summarized in Table 4b) shows

positive and significantly higher net

benefits at concentrations up to 2,000

ppm than for soil-lead concentrations

above 2,000 ppm. Positive net benefits

indicate that the cost of soil abatement

at this concentration is less than the

benefits associated with risk reduction

for the population as a whole. Because

both analyses show positive net benefits

at 2,000 ppm, EPA is confident that this

level represents a reasonable public

health policy choice for today’s

proposal.

As stated previously, EPA conducted

the normative cost-benefit analysis for

purposes of comparing options. Undue

emphasis should not be placed on the

total costs and benefits estimated by

each analysis. It is probably more

useful, therefore, to consider what the

Agency’s analysis and decision implies

for the average property. According to

EPA’s analysis, the average cost of soil

abatement for a residence at 2,000 ppm

is about $3,600. The analyses show that

cost is commensurate with risk

reduction at this concentration because

the value of risk reduction in terms of

avoided adverse health effects is greater

than the cost. It is important to

recognize, however, that the benefits
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30329

account not only for the child

immediately protected when the

abatement is performed but also for

children who may reside in that

residence in the future. The comparison

of estimated costs and benefits for an

individual property is also an average.

For some homes, costs could be higher

than benefits. EPA’s decision, however,

is based on the overall benefit to society

which accounts for benefits for future

generations of children and for the

average child.

Second, outside of its use in the

economics model, the IEUBK model

predicts significant risk to children at

this soil-lead concentration under

virtually all exposure scenarios. At

2,000 ppm in soil, the model estimates

a mean blood lead level in the range of

11-16 μg/dl, depending upon the

assumed concentration of lead in house

dust (100-1,400 ppm in this case). This

range corresponds to approximately 55

to 80 percent equal to or exceeding 10

μg/dl and 9 to 30 percent exceeding 20

μg/dl.

Third, data from a number of

epidemiological studies show that

between 40 and 50 percent of the

children living in certain communities

with soil-lead concentrations at the

2,000 ppm level have blood-lead

concentrations equal to or exceeding 10

μg/dl and that 10 percent of children

have blood-lead concentrations equal to

or exceeding 20 μg/dl (Ref. 85).

In reaching its decision, EPA rejected

more stringent options for several

reasons. First, although the IEUBK

model-based analysis shows higher net

benefits for more stringent standards,

the results of the IEUBK model-based

analysis at relatively low soil-lead

concentrations (e.g., 500 ppm) are very

sensitive to assumptions in both the

analysis and the model. As noted above,

a significant proportion of these benefits

are associated with changes in dust

concentration which are affected by

both the HUD National Survey data and

EPA’s assumptions about postintervention dust concentrations. The

results are also very sensitive to the

assumed relationship between soil-lead

and blood-lead concentrations in the

IEUBK model. Because of the larger

number of homes at lower soil-lead

concentrations (e.g., 11.8 million ≤ 500

ppm versus 2.5 million ≤ 2,000 ppm)

and the smaller reductions in

environmental lead levels that can be

achieved at the lower concentrations, a

slight change in the relationship

between soil-lead and blood-lead

concentrations can produce

significantly different net benefits.

Consequently, it is questionable

whether risk reduction would be

commensurate with costs and lower

soil-lead concentrations.

Second, the Agency’s analysis did not

consider the role that interim controls

can play in reducing risks at lower soillead concentrations. Interim controls

were not considered because EPA lacks

data to estimate the effectiveness of

these controls. The Agency believes that

at lower soil-lead concentrations,

interim measures can interfere with

exposure pathways and reduce risk and

that these measures may be more cost

effective than abatement at lower

concentrations.

Third, EPA is concerned that more

stringent standards would not meet the

priority-setting goals the Agency

believes are appropriate for the Title X

program. Based on the soil-lead data in

the HUD National Survey, EPA

estimates that 4.7 million homes would

exceed 1,200 ppm and nearly 12 million

homes would exceed 500 ppm, two

options considered by the Agency.

Scarce resources potentially would have

to be allocated across more communities

and would be diverted away from

interventions needed to respond to both

deteriorated interior and exterior leadbased paint. The proposed 2,000 ppm

standard will help focus resources for

soil abatement on significantly fewer

properties (i.e., 2.5 million).

In proposing 2,000 ppm as the soillead hazard standard, EPA does not

wish to communicate a lack of concern

about risks that exists below this soillead concentration. In fact, the Agency

recognizes that there could be

substantial risk below 2,000 ppm. The

IEUBK model predicts risk to children

under a variety of exposure scenarios.

At 1,200 ppm in soil, the model

estimates a mean blood lead level in the

range of 8 to 11 μg/dl, depending upon

the assumed concentration of lead in

house dust (100 to 850 ppm in this

case). This range of mean blood-lead

concentrations corresponds to a range of

approximately 30 to 60 percent

exceeding 10 μg/dl and 2 to 10 percent

exceeding 20 μg/dl. As noted above,

however, the Agency believes that it is

not appropriate to set a more stringent

uniform national soil-lead hazard

standard because costs may not be

commensurate with risk reduction and

resources would not be adequately

focused. The Agency further thinks that

measures undertaken in response to the

proposed soil-lead level of concern in

the accompanying guidance and dust

hazard standards will help protect

children exposed to soil-lead

concentrations between 400 ppm and

2,000 ppm. It should be noted that

abatement at levels below 2,000 ppm

may be appropriate on a case-by-case

basis depending on local conditions.

EPA also considered a less stringent

standard of 5,000 ppm. This option has

several advantages. First, consistent

with the priority-setting concept of Title

X and the need to apply scarce

resources effectively, as noted in Unit

IV.A.2.b, this option would focus on

properties that present the greatest risk

to young children. Second, it would

affect relatively few homes (i.e., an

estimated 200,000 units based on data

from the HUD National Survey).

Because fewer homes would be affected,

the estimated cost associated with this

option, as shown in Tables 5 and 7, is

significantly lower than the cost of the

preferred option ($0.4 billion for 5,000

ppm vs. $9 billion for 2,000 ppm), thus

reducing the impact of the rule on

properties and communities. In fact,

according to the empirical model-based

approach, the net benefits are about the

same for 5,000 ppm and 2,000 ppm.

Third, this level would be consistent

with EPA’s interim guidance document

on lead-based paint hazards (60 FR

47248). Some argue that the adoption of

a more stringent soil hazard standard —

given the substantial costs of soil

abatement — may influence the

decisions or actions of owners of target

housing in unintended ways. The

Agency is interested in receiving

comments on how the hazard standard

may influence owners, the number of

clean-ups or interventions, and whether

the hazard standard would influence

housing availability. In discussions at

EPA’s dialogue process, many interested

parties stated that the guidance was a

workable approach that should be

adopted in the regulation.

This option, however, is characterized

by several important disadvantages.

First, the IEUBK model predicts, and the

epidemiological data show, that a

substantial number of children who are

exposed to soil with lead levels between

2,000 ppm and 5,000 ppm have

moderately to highly elevated blood

lead levels. Furthermore, interim

controls would be relied upon to

address risks from soil-lead

concentrations up to 5,000 ppm under

this option. It is important to consider

that interim controls, which may

successfully mitigate risks at lower soil

lead concentrations, do not eliminate

the lead source. Rather, they serve to

reduce exposure by limiting the

accessibility of the soil and the

consequent inadvertent ingestion or

tracking of the soil into a home (where

it can contribute lead to interior dust).

As the soil lead concentration increases,

however, it is more likely that even if

accessibility of the soil were reduced,
30330 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

significant risk would remain. In the

case of track-in, the Agency is

concerned that even a relatively small

amount of high-lead-concentration soil

can re-contaminate interior dust and

reintroduce a dust-lead hazard. Second,

although, as stated above, costs may be

lower at 5,000 ppm, the IEUBK modelbased approach shows that net benefits

also decrease by $32 billion when

increasing the standard from 2,000 ppm

to 5,000 ppm. Furthermore, the

empirical model-based approach shows

that, while net benefits are about the

same for both options, benefits decline

by $9 billion when the standard

increases from 2,000 ppm to 5,000 ppm.

In light of the results of EPA’s formal

cost-benefit analysis, the risk

predictions of the IEUBK model, and the

risk to young children documented by

the epidemiological data, EPA decided

that 2,000 ppm was a more appropriate

option for today’s proposal. In reaching

this decision, EPA was mindful of the

impacts that the costs of soil abatement

could have on individual properties and

communities. Consideration of costs

and their impacts was the primary

reason why EPA selected 2,000 ppm

rather than a more stringent option (e.g.,

1,200 ppm). Moreover, EPA would have

selected 2,000 ppm as its preferred

option even if the Agency had relied

only on the empirical model and

epidemiological data as some

stakeholders have suggested. The results

of the empirical model-based analysis

show that both the 2,000 ppm option

and the 5,000 ppm option are equivalent

in terms of net benefits. The benefits at

2,000 ppm, however, are substantially

higher because, as the epidemiological

data shows, there is substantial risk to

children exposed to lead in soil at

concentrations between 2,000 ppm and

5,000 ppm.

EPA notes that it does not anticipate

that setting the soil-lead hazard

standard at 2,000 ppm would adversely

impact individuals who previously

relied voluntarily on the guidance. First,

EPA has no information to suggest that

many property owners have performed

soil abatements. Second, it is very likely

that properties where soil abatements

were performed would now have soillead concentrations well below 2,000

ppm and even below 400 ppm, the soillead level of concern. This conclusion is

based on the fact that when soil is

removed, it is replaced by ‘‘clean’’ soil-

-soil that has a very low lead

concentration.

D. Hazardous Lead-Based Paint

This section of the preamble presents

EPA’s proposed standard for

deteriorated lead-based paint. It also

presents options for addressing leadbased paint on friction and impact

surfaces and lead-based paint on

surfaces accessible for chewing and

mouthing by young children. The

Agency, however, is not proposing

standards for lead-based paint on

friction, impact, and accessible surfaces,

but is, instead, asking for public

comments on the options presented

below.

For any type of hazardous lead-based

paint, the paint must be lead-based

according to the statutory definition

(i.e., ≥1 mg/cm2 or 0.5 percent by

weight). Determination of whether the

paint is lead-based is made by a

certified inspector or risk assessor based

on testing results. EPA is developing a

separate guidance document that will

address paint sampling.

1. Deteriorated lead-based paint. To

meet the statutory requirement to

identify hazardous lead-based paint,

EPA must determine those conditions of

deteriorated lead-based paint which

would result in adverse human health

effects.

Exposure to deteriorated lead-based

paint can result in adverse human

health effects, based on the fact that

children can be exposed to lead through

several pathways when lead-based paint

is deteriorated and that studies

document an association between

children’s blood-lead concentrations

and the presence of deteriorated leadbased paint. EPA, however, is unaware

of any data that would allow the Agency

to more specifically relate conditions of

deterioration (e.g., levels of lead in

paint, minimum area of deteriorated

lead-based paint) to blood-lead

concentration. The Agency, therefore,

has chosen to propose a standard for

deteriorated paint using the criteria for

paint condition in Table 5.3 of the HUD

Guidelines (Ref. 11) for the reasons

discussed below.

Exposure to lead from deteriorated

lead-based paint can occur in three

ways. First, children who exhibit pica,

a hunger for substances not fit for food,

may eat paint chips (Ref. 86). Second,

deteriorated interior lead-based paint

can contaminate household dust which

may be inadvertently ingested by

children through normal hand-to-mouth

behavior. Third, deteriorated exterior

lead-based paint can contaminate

residential soil which can also be

inadvertently ingested by children. Soil,

in turn, can be tracked into a residence,

contaminating the household dust.

These three scenarios have been

demonstrated in various studies that

used stable isotopes of lead as tracers

(see, e.g., Refs. 87 and 89). Basically,

this technique relies upon the fact that

the isotope ratios of lead ores vary by

deposit. Consequently, lead-containing

products, such as lead-based paints and

leaded gasolines, can have unique ratios

of the stable isotopes in the lead.

Comparison of the isotope ratios in

these products to those of

environmental media and blood can in

some cases identify categories of

products as the source of lead in the

environmental media and/or lead in the

blood.

Rabinowitz (1987) reports use of this

technique to investigate the specific

sources and pathways of lead exposure

in three cases of chronic, high-level lead

poisoning (blood-lead concentrations of

120, 83, and 66 μg/dl) (Ref. 90). In each

case, blood, feces, and the child’s home

environment (paint, dust, and soil) were

sampled and analyzed. All of the

children had deteriorated paint present

in their homes. Additionally, a series of

environmental samples were collected

and analyzed to characterize

background lead throughout the city.

In the first two cases, the isotopic

composition of the blood (indicative of

chronic exposure) and the feces

(indicative of exposure during the

preceding day) were nearly identical. In

the first case, they resembled the paint

sample from the child’s bedroom wall

(which was similar to the exterior soil).

In the second case, they closely matched

the lead in window sill paint, but not

the kitchen wall or garden soil. In the

third case, the blood lead was close to

that of the paint in the child’s bedroom,

which was believed to be the source of

his chronic exposure, whereas the fecal

lead appeared to be similar to fallout

from current automobile emissions in

the area. While such data do present

some ambiguities, they are consistent

with paint being the proximate or

remote source of the child’s lead

exposure and the author’s conclusion

that, in cases of severe lead poisoning,

the lead in the child’s blood and feces

closely resembles lead in paint on an

accessible surface. Additionally, based

upon isotopic comparisons between

household dust and urban soils, the

study also concluded that: (1) In the

absence of lead-based paint, the leads in

urban soils and household dust have

nearly the same isotopic composition,

and (2) lead-based paint, when present,

can be responsible for 20 to 70 percent

of lead in household dust and much of

the lead in yard soil.

Yaffe, et al. presented two cases

which also included measurement of

the isotopic ratios of lead in blood,

paint, dust, and soil (Ref. 89) . In both

cases, it was unlikely that direct

ingestion of paint chips was the cause

of the elevated blood-lead
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30331

concentrations. This was based on the

facts that: (1) There was no indication

that the children were pica-prone based

upon interviews with the children and

their parents, and (2) higher than

exhibited blood-lead concentrations

would be expected if paint chips were

being ingested, given the very high lead

levels in the paint.

The first case involved 10 children

with blood-lead concentrations from 28

to 43 μg/dl. The isotopic ratios of the

children’s blood lead were similar,

suggesting a common set of lead

exposures. These ratios were quite

similar to those of soil samples collected

around the house and interior dust

samples. The close agreement between

the average isotopic ratios of exterior

paint samples and the soils near the

house suggested that the soil was

contaminated by the exterior paint,

which was badly deteriorated.

The second case involved twin 2–year

old males with blood-lead

concentrations of 37 and 43 μg/dl. The

isotopic ratios of the twins’ blood lead

were similar to the soil in their side

yard and in the back yard of a nearby

house where they often played. These

soils had similar ratios to adjacent

exterior walls. This suggests that the

lead in the soils was primarily derived

from the weathering of nearby painted

surfaces and that the contaminated soil

was a significant source of the twins’

exposure. The interior dust sample lead

was not similar to the exterior soil or the

twins’ blood lead. Such cases, where

soil or dust becomes contaminated by

deteriorating paint, demonstrate the

need for a paint standard as well as soil

and dust standards. Lacking a paint

standard, the paint can continue to recontaminate soil and dust, rendering

abatement and control measures

directed at those two media ineffective.

The scientific literature also includes

several studies that have identified a

statistically significant relationship

between deteriorated paint and

children’s blood-lead concentrations.

One study suggests that infant bloodlead concentrations are a function of

paint deterioration and lack of

maintenance of the residence (Ref. 91).

In this study, housing was classified as

deteriorated if the exterior was not well

maintained or had peeling paint, as

observed from the street. For infants at

12 to 18 months old, geometric mean

blood-lead concentrations were twice as

high in deteriorated housing (33 μg/dl)

than in housing graded as satisfactory

(15 μg/dl).

Another study identified statistically

significant correlations between the

presence of both deteriorated interior

and exterior lead-based paint and

children’s blood-lead concentrations

(Ref. 92). Presence of peeling exterior

paint was among the most influential

factors explaining the blood-lead

concentrations of 2-year olds. It should

be noted, however, that lead levels in

paint were not reported in the paper.

Therefore, it is not certain that the

results of this study actually represent

deteriorated lead-based paint.

Analysis of data from the Rochester

Lead-in-Dust Study performed to

support this rule’s comprehensive risk

analysis also shows a relationship

between deteriorated lead-based paint

and children’s blood-lead

concentrations. The empirical model,

which explicitly incorporated pica

behavior, yielded a significant positive

relationship between deteriorated paint

and children’s blood-lead

concentrations (Ref. 1).

Analysis of the HUD National Survey

data suggests that deteriorated leadbased paint is indirectly linked to

elevated blood-lead concentrations in

young children through lead in

household dust and residential soil

(Refs. 8-9, and 19). Of those homes with

interior lead-based paint, 34 percent

with non-intact paint had elevated dust

lead levels (i.e., elevated in comparison

to HUD’s dust clearance levels at the

time the survey was conducted)

compared to 18 percent of homes with

intact paint. Of those homes with

exterior lead-based paint, 53 percent of

homes with non-intact paint had

elevated dust lead levels compared to 12

percent with intact paint. Although

correlation analysis cannot be used to

prove causation, EPA believes that it is

reasonable to conclude that the lead in

the deteriorating paint is a significant

source of the lead in the dust and soil.

Based on its analysis of existing

studies and data, EPA believes that

deteriorated paint is a significant source

of lead exposure for young children

through direct ingestion and through

contamination of dust and soil. To

promote priority setting and the

establishment of a workable program,

EPA thinks that the standard for

deteriorated lead-based paint should

exclude small amounts of deterioration.

From a common sense perspective, it

seems that there should be lower

exposure and risk from lead-based paint

where there are lesser amounts of

deteriorated lead-based paint. There

would be fewer paint chips to

contribute lead to dust and fewer paint

chips available for direct ingestion.

Because there are no data to directly

relate the degree of deterioration to

blood-lead, EPA was unable to perform

an analysis to specify a minimal area of

deterioration that would be considered

a hazard. The Agency therefore has

decided to propose the conditions of

deterioration used currently in the 1995

HUD Guidelines. The HUD Guidelines

define lead-based paint in poor

condition as more than 2 square feet of

deteriorated lead-based paint on any

large interior architectural component

(e.g., floors, walls, ceilings, doors, etc.),

more than 10 square feet of deteriorated

lead-based paint on any large exterior

architectural component (e.g., siding), or

deteriorated lead-based paint on more

than 10 percent of the surface area of

any small architectural component

constitutes hazardous lead-based paint.

The Agency decided to use the

criteria in the HUD Guidelines for two

reasons. First, these criteria are

becoming the de facto industry

standard. They are being considered for

incorporation into model housing and

building codes and by State officials for

adoption as State standards. Second,

EPA decided that relatively small

thresholds are needed to be protective,

because the area of deterioration has the

potential to increase over time and

because the presence of even small

amounts of deterioration can present a

significant risk to children who exhibit

pica for paint. The Agency wishes to

emphasize that while areas of

deteriorated paint that fall below the

threshold would not be considered a

hazard, property owners should try to

keep paint intact, especially paint

known to be lead-based, because of the

risk to some children.

EPA cannot quantify the cost savings

of including a minimum area of

deteriorated lead-based paint. The

Agency presumes, however, based on

the available data, the minimum area

threshold would reduce the number of

paint interventions that may be

undertaken while still providing

protection to populations of concern.

For example, according to the HUD

National Survey, of the estimated 15

million homes currently in the housing

stock that have deteriorated lead-based

paint, 11 percent have less than 5 square

feet of deteriorated paint and 36 percent

have less than 10 square feet of

deterioration (Ref. 93). With a de

minimis level in place, millions of

homes would not be identified as

having hazardous deteriorated paint. It

is important to note, however, that the

presentation of these data is only

intended to provide a frame of

reference. They are not comparable to

the criteria in the HUD Guidelines

because these criteria are componentbased and the data in the HUD National

Survey apply to the aggregate area of

deteriorated paint in the entire

residence.
30332 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

EPA considered two other options for

identifying the conditions where

deteriorated lead-based paint would be

defined as a hazard. One alternative

involved combining surface area with

the levels of lead in paint. This

approach is based on the assumption

that the hazard presented by an area of

highly concentrated deteriorated leadbased paint is greater than the hazard

presented by an equal area of

deteriorated paint with a lower

concentration of lead. Although this

assumption is technically appealing,

EPA has no basis for establishing the

appropriate combinations of area and

lead loadings. Furthermore, the Agency

believes that this approach would be

overly complex and costly to implement

because it would require significantly

more paint testing.

The second alternative involved

measuring the aggregate amount of

deteriorated lead-based paint at an

entire residence, as was measured in the

HUD National Survey, rather than on

individual architectural components, as

is provided for in the HUD Guidelines.

The advantage of this approach would

be that the aggregate amount of

deteriorated lead-based paint at an

entire residence may be a better

indicator of risk than the amount of

deteriorated paint on individual

components. EPA, however, has no data

to support this assumption or to select

a minimum area. In addition, this

approach may be more expensive to

implement because it could require the

risk assessor to test all deteriorated

paint on all individual components to

determine whether the aggregate area of

deteriorated lead-based paint exceeds

the threshold. In contrast, the

component-based approach would be

less expensive because it would require

the risk assessor to test deteriorated

paint on only those components where

the deterioration exceeds the area

threshold. Furthermore, the componentbased approach is consistent with paint

abatement activities, which addresses

hazards on individual components.

In light of the uncertainty associated

with EPA’s decision, the Agency is

seeking comment on several issues

related to the deteriorated lead-based

paint hazard standard. First, EPA is

interested in any data the public may

have that would enable the Agency to

better characterize the relationship

between the amount of deteriorated

lead-based paint and health risk.

Second, EPA requests comments on the

surface area hazard thresholds included

in the proposed standard. Third, the

Agency is seeking comment on whether

the proposed component-based area

threshold is better than an aggregate

residence-based threshold.

2. Friction and impact surfaces. Title

IV of TSCA specifically identifies leadbased paint on friction and impact

surfaces as a potential type of hazardous

lead-based paint because the repeated

rubbing and impacts may generate fine

particles of lead-containing paint that

can contaminate household dust. TSCA

section 401 defines friction surfaces as

surfaces that are subject to abrasion or

friction including certain window, floor,

and stair surfaces. Impact surfaces are

surfaces subject to damage by repeated

impacts such as certain parts of a door

frame.

The data linking lead-based paint on

friction and impact surfaces with lead in

dust, however, are limited and

inconclusive. Analysis of the HUD

grantee data shows that there are many

instances where lead-based paint on

friction and impact surfaces and low

dust-lead levels may be found in the

same residence (Ref. 94). These data

were collected from homes undergoing

hazard evaluation and control under

lead hazard control grants awarded by

HUD under authority of section 1011 of

Title X. In fact, of the windows with

lead-based paint in good condition, 65

percent had dust-lead levels below the

HUD clearance level. These data

suggest, contrary to the conventional

wisdom, that lead-based paint on

friction and impact surfaces does not

necessarily result in elevated levels of

lead in household dust. Even if elevated

levels of lead in dust are identified, it

is not clear that lead-based paint on

friction and impact surfaces is the

source of the lead. In light of the

uncertainties and contradictory

evidence, EPA considered several

alternatives for addressing these

surfaces.

When reviewing these alternatives,

the public should be mindful that the

options for lead-based paint on friction

and impact surfaces are designed to

address exposure through ingestion of

dust contaminated with lead. Leadbased paint is always a hazard when it

is in poor condition, regardless of its

location in a residence. The paint in

poor condition critierion is designed to

address exposure through direct

ingestion of paint chips.

Option 1. Under this alternative, EPA

considered identifying any lead-based

paint on a friction or impact surfaces as

a lead-based paint hazard. The Agency

considered this option because it is the

approach taken in EPA’s July 1994

guidance. The major advantage of this

option is that it is designed to address

a source of dust contamination.

On the other hand, the data show that

surfaces that have lead-based paint in

good condition do not necessarily

generate elevated levels of lead in dust

(Ref. 94). This option is also

inconsistent with several of the

statutory precepts (i.e., priority-setting,

establishing a workable framework)

because it would result in widespread

paint testing and/or costly responses

even where dust-lead hazards are not

present.

Option 2. Under the second option,

EPA considered identifying abraded

lead-based paint on friction and impact

surfaces as hazardous lead-based paint.

The point of this option is that it

identifies a condition, abrasion,

associated with the generation of leaded

dust, thus overcoming the chief

deficiency of the first option. It shares

the advantage of option one in that it is

designed to address a source of dust

contamination.

On the other hand, this option is

characterized by several disadvantages.

It would identify friction or impact

surfaces as a hazard regardless of the

dust-lead levels present in the

residence. Without a dust-lead hazard,

there appears to be no pathway of

exposure. Even if a dust-lead hazard is

present, there is no certainty that the

friction and impact surfaces are the

source of the lead. As with option one,

this option would result in paint testing

and/or costly responses in many older

homes because of the high prevalence of

abraded paint, even if there is no

evidence that these surfaces are

contributing to elevated levels of lead in

dust.

Option 3. Under the third option, EPA

would not identify lead-based paint on

friction and impact surface as hazardous

lead-based paint. A risk assessor should

evaluate the levels of lead in dust and

determine whether a dust-lead hazard is

present in the residence. If so, the

property owner or other decision-maker

has the option to clean dust, which may

provide only short-term control of the

hazard, or to address the sources of lead

in the dust, including friction and

impact surfaces, which would provide

long-term control. The purpose of this

option is to address the immediate

exposure source for children, which is

lead in the dust, and to provide

flexibility to property owners regarding

how to control hazards.

This option has several disadvantages.

First, this option is not designed to

address the source of lead but rather the

exposure pathway. A second

disadvantage is that this option depends

on dust-lead measurements, which are

highly variable, to determine whether

there is a problem. If a risk assessor
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30333

obtains an atypically low dust

measurement, he/she might not identify

friction and impact surfaces as a

potential source of contamination.

Third, it fails to address directly a

component that was specifically

identified in the statute.

For today’s proposal, EPA has

decided not to include a standard for

friction and impact surfaces. None of

the three options is clearly preferable.

The first two options are designed to

address sources of lead. The primary

pathway of exposure, however, is lead

dust, and, it makes little sense to burden

a system with potential replacement of

components if there is no serious dust

exposure.

The third option overcomes these

disadvantages, providing an incremental

and flexible approach that indicates

response actions where there is an

exposure pathway (i.e., presence of

dust) and allows decision-makers to

choose the most cost-effective response

(i.e, repeated dust cleaning or

component replacement). On the other

hand, this option fails to set a separate

standard for surfaces of concern that

were specifically identified in the

statute. Because this option relies

exclusively on dust loading

measurements, which are highly

variable, it may fail to identify sources

of hazards and may not be adequately

protective.

In light of the concern about friction

and impact surfaces and the

uncertainties and contradictory data,

EPA requests comment on the three

options presented above. EPA would

also be interested in other approaches

for addressing lead-based paint on

friction and impact surfaces.

3. Surfaces accessible for chewing or

mouthing. TSCA section 403 also

requires EPA to identify the conditions

under which exposure to intact leadbased paint on surfaces accessible for

chewing or mouthing by young children

would result in adverse human health

effects. Chewing on surfaces covered by

lead-based paint can result in the

ingestion of a relatively large amount of

lead, leading to an acutely high

exposure. Unlike pica, which is not

considered normal behavior and occurs

in a relatively small percentage of the

population, the chewing or mouthing of

hard surfaces is a normal part of a

child’s teething process.

The available data with respect to

prevalence of mouthing or chewing of

accessible surfaces are mixed.

Radiological examinations of the

children with high blood-lead

concentrations (mean blood-lead

concentration was 56 μg/dl) showed that

13 of 90 children (14 percent) had

evidence of paint chip ingestion (Ref.

95). The study notes, however, that the

transit time of ingested material through

a child’s digestive system ranges from

several hours to several days. Because

the half-life of lead in blood is 30 days,

radiographs will reveal only a small

percentage of children who have

elevated blood-lead concentrations due

to the ingestion of a single paint chip.

On the other hand, data from HUD’s

lead hazard control grant recipients

show that the prevalence of chewing

accessible surfaces is extremely low. In

the nearly 1,900 homes assessed,

evidence of chewing on accessible

surfaces was found in 21 residences (1.1

percent). The number of homes with

accessible surfaces, however, was not

determined. Window sills were the most

frequently chewed component. The data

show, however, that tooth marks were

found on window sills in only 18

residences (one percent) (Ref. 96).

In developing today’s proposal, EPA

considered several options for

addressing intact lead-based paint on

accessible surfaces.

Option 1. Under the first option, EPA

considered identifying characteristics of

a component’s accessibility. These

characteristics would include the

dimensions of a component as well as

its orientation (e.g., horizontal

components such as sills, vertical

components such as rail spindles) and

location (e.g., height of component).

This approach would limit the number

of surfaces which might be considered

hazards to those which could

potentially be chewed or mouthed. This

approach, however, would significantly

change the scope of risk assessments as

currently defined at 40 CFR 745.227(d).

In addition, the Agency lacks data to

support the choice of specific criteria.

Therefore, the Agency does not consider

this an appropriate option.

Option 2. Under the second option,

EPA considered not adopting a separate

standard for surfaces accessible for

chewing or mouthing. Hazardous leadbased paint would exist only if leadbased paint on the component were

determined to be in poor condition.

This approach would avoid requiring

property owners to expend resources to

address accessible surfaces when, in the

vast majority of situations, these

surfaces are not likely to be chewed or

mouthed. This approach, however,

would do nothing to address the

infrequent, but often serious problem of

children chewing or mouthing

accessible surfaces, unless and until that

actively resulted in significant

deterioration of the surface.

Option 3. Under the third option, EPA

would identify lead-based paint on

accessible interior window sills because

these are the surfaces most likely to be

chewed according to the available data.

EPA would propose to define accessible

interior window sills as interior window

sills that are no higher than 5 feet from

the floor, a height that can be reached

by a child when standing on the floor

or on a chair or sofa. By targeting these

surfaces, hazard intervention (e.g.,

covering or replacing the component)

would be more cost-effective than an

approach that identified lead-based

paint on any accessible surface as a

hazard. This option also has the

advantage of being easy to implement,

because specific surfaces (e.g., window

sills) are easy to identify. On the other

hand, it would result in interventions

where, in the vast majority of cases,

children do not need to be protected.

EPA’s decision requires the Agency to

balance an event (i.e., chewing of

interior window sills) that has a low

probability of occurring with the high

probability of serious harm when the

event does occur. By not establishing a

hazard standard for accessible surfaces,

option two gives greater weight to the

event’s low probability. In contrast,

option three is more focused on the

adverse outcome associated with

chewing of paint on these surfaces.

Because neither of these two options is

clearly preferable, EPA is not selecting

a preferred option for today’s proposal.

Instead the Agency is seeking comment

on options two and three. In particular,

the Agency would be interested in input

on three issues: (1) How to balance the

low probability of chewing with the

high probability of serious harm if

chewing occurs; (2) low cost alternatives

to sill replacement (e.g., paint removal);

and (3) the effectiveness of guidance to

property owners to temporarily cover

sills when a child who demonstrates a

propensity to chew resides in the unit.

EPA also invites the public to submit

data on the prevalence of chewing on

accessible surfaces.

V. Other Issues Affecting Standards

Development and Selection

During the regulatory development

process, EPA encountered a range of

issues that affect the scope and structure

of today’s proposal and the

implementation of the standards.

A. Applicability of the Standards

Two factors affect the applicability of

the proposed standards for lead-based

paint hazards: the statutory language

and the scope of the Agency’s

supporting analyses. With respect to the

statutory language, the term ‘‘lead-based

paint hazards’’ refers to target housing

in most sections of Title X and TSCA
30334 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

Title IV. TSCA section 402 also uses the

term in reference to public and

commercial buildings and structures

(e.g, water towers, bridges). The

statutory definitions of leadcontaminated dust and soil, however,

refer only to residential property,

showing that the applicability of the

dust and soil standards differs from the

applicability of the paint standards. The

Agency’s analyses are based on data for

residential exposure, thereby raising

questions regarding whether the

standards being proposed today would

be appropriate for non-residential

environments. This section of the

preamble explores the applicability

issue and the Agency’s decision, first,

with respect to the paint component of

the standards and second, with respect

to the dust and soil standards.

1. Paint. The definitions in TSCA

section 401 do not explicitly identify

the applicability of hazardous leadbased paint. The definition of leadbased paint hazard refers to deteriorated

lead-based paint and lead-based paint

on friction, impact, and accessible

surfaces. The reference to deteriorated

lead-based paint does not identify

specific types of properties, nor do the

definitions of friction, impact, and

chewable surfaces. As noted above,

however, the term ‘‘lead-based paint

hazard’’ is used in context of target

housing. The definition of deleading in

TSCA refers to lead-based paint and

lead-based paint hazards and, in doing

so, extends the scope of lead-based

paint hazards to non-residential

properties as well. The statutory

language, therefore, shows that the paint

standard should be applicable to target

housing, public and commercial

buildings, and structures.

EPA, however, has no data on

children’s exposure to lead in paint in

non-residential environments. The

Agency, therefore, believes that the

paint standards being proposed today

should apply to target housing. The

Agency has also decided to propose that

the paint standards apply to childoccupied facilities. Although EPA lacks

data on exposure in child-occupied

facilities, the Agency believes that

children face potentially equivalent

risks from lead-based paint hazards in

schools and day-care centers as they do

at home. EPA based its decision to

apply the same training, certification

and work practice standards to both

target housing and child-occupied

facilities in the final TSCA section 402

regulation on the same argument.

In the absence of environmental and

exposure data for other types of

properties, the Agency has decided not

to propose paint standards that are

applicable to other types of public

buildings, commercial buildings, and

structures at this time. EPA believes,

however, that this limitation should not

have any meaningful impact on the

regulation and its ability to protect

human health. Lead-based paint

encompasses lead-based paint hazards

and lead-based paint is defined. Because

the applicability of the proposed

standard for hazardous lead-based paint

is more limited than that required in the

statutory language, the Agency is

specifically requesting comment on this

decision.

2. Dust and soil. In contrast to paint,

the statutory language is more limited in

defining the applicability of the dust

and soil standards. In TSCA section 401,

the statute specifically identifies leadcontaminated dust and soil in terms of

‘‘dust in residential dwellings’’ and

‘‘bare soil on residential real property.’’

TSCA section 403 states that EPA

should identify lead-based paint

hazards for purposes of Title X and

TSCA Title IV which focus on a specific

subset of residential property, namely

target housing which includes most pre1978 housing. The statutory language

shows that the dust and soil standards

should apply to target housing.

EPA has decided, however, to

interpret residential more broadly and

to propose that the dust and soil

standards should apply to childoccupied facilities as well as to target

housing. This decision is based on the

same rationale for applying the paint

standards to child-occupied facilities.

As argued in the preamble to the final

TSCA section 402 regulation, the

Agency believes that children face

potentially equivalent risks from leadbased paint hazards in schools and daycare centers as they do at home. In fact,

some children spend more time in a

particular classroom, day-care room, or

outdoor ‘‘play area’’ then they might

spend in a single room or yard at home.

Failure to apply the dust and soil

standards to child-occupied facilities

would leave a significant gap in the

work practice standards for risk

assessments and abatements at childoccupied facilities. Without dust and

soil standards for child-occupied

facilities, risk assessors would not be

able to determine whether dust-lead and

soil-lead hazards are present at these

facilities. Because abatements are

defined as actions designed to

permanently eliminate lead-based paint

hazards, owners of these facilities

would be unable to determine what

activities constitute abatement and

when certified firms and individuals are

required to perform these activities.

In light of EPA’s decision to propose

applying the dust and soil standards

more broadly than a literal reading of

the statute would suggest, the Agency is

seeking comment on this aspect of the

regulation. Specifically, EPA would be

interested in any disadvantages

associated with this decision and in

alternative approaches that would

provide as much protection to children.

3. Child-occupied facilities. Because

child-occupied facilities are often

located within larger facilities where

children would have limited or no

access, the applicability of the hazard

standards to these facilities requires

further explanation. The definition of

child-occupied facilities found at 40

CFR 745.227 helps clarify the

applicability of the hazard standards to

child-occupied facilities. First, a childoccupied facility must have been

constructed prior to 1978. Second, a

child-occupied facility is a building or

portion of a building visited regularly by

children age 6 and under. The definition

provides several examples including

day care centers, pre-schools, and

kindergarten classrooms. By limiting the

meaning of a child-occupied facility to

the portion of a building where a child

regularly visits, the definition limits the

applicability of the paint, dust, and soillead hazard standards to the same

portion of a building. For example, the

soil standard would apply only to that

portion of the area outside the building

designated for use by children age 6 and

under.

Several examples may help illustrate

how the hazard standards apply to

child-occupied facilities. The first

example is a day care center at a

manufacturing facility. There is a

separate entrance to the center and a

fenced playground area adjoining the

center. In this case, the center (interior

rooms and outside area making up the

center), not the entire plant is the childoccupied facility. Paint and dust

samples would be taken from the rooms

in the day care center, and soil samples

would be taken from within the fenced

playground. Hazard interventions

should be limited to those areas. The

second example is a stand-alone preschool (i.e., the pre-school occupies the

entire structure). In this case, the

standards would apply to the entire

property. The third example is a

kindergarten at a public or private

school which has a yard for recess

designated for use by children age 6 and

under. In this case, the paint and dust

standards would apply to the

kindergarten classrooms and the soil

standard would apply to the school yard

designated for use by the kindergarten

children (i.e., except for the portions of
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30335

the property such as the front lawn of

the school that are not designated for

use by children age 6 and under). As a

final example, a day care center is

located within a public or private high

school. The school has several outside

recreational areas, none of which are

designated for regular use by children

who attend the day care center. The day

care consists of a class room, which is

now divided into two main rooms. In

this scenario, the hazard standards only

apply to the interior area because the

outside areas would not be defined as

part of the child-occupied facility.

B. Dust Issues

1. Loading vs. concentration. Title X

provides the legal basis for selecting the

levels of lead that constitute dust-lead

hazards. The statute, however, does not

stipulate the measurement basis for the

dust standards. Two different measures

are commonly used to characterize the

lead level in dust: loading and

concentration. Lead concentration (or

mass concentration) is a measure of how

much lead is present in a given amount

of dust and can be expressed in either

micrograms of lead per gram of dust (μg/

g) or, equivalently, in parts per million

(ppm) by weight. Lead loading or area

concentration, a measure of how much

lead is present on a surface of given

area, is expressed in mass of lead per

area of surface sampled (typically, μg/ft2

or μg/m2).

The two measures also differ in the

way environmental sampling is

conducted. Dust-lead loading data can

be obtained through either wipe

sampling or vacuum sampling.

Concentration data are usually obtained

through vacuum sampling. In wipe

sampling, a wet wipe (e.g., baby wipe)

is used to collect dust from a surface

with known area. Through laboratory

analysis, the total lead picked up by the

wipe is measured and compared to the

surface area to calculate the dust-lead

loading. Because the wipe sampling

only measures the mass of the lead and

not the total mass of the dust, the

concentration of lead in the dust cannot

be determined. In a wipe test, the mass

of the dust is combined with the mass

of the wipe which is typically unknown.

Therefore, it is not possible to isolate

the mass of the dust and compute the

concentration.

In vacuum sampling, a specialized

vacuum cleaner is used to collect dust

from a surface with known area.

Through laboratory analysis, the amount

of lead picked up by the vacuum can be

measured and compared to the surface

area to calculate loading. Laboratory

analysis also can yield the concentration

measure because the only material in

the sample is the dust (including the

lead). It is, therefore, possible to obtain

both the total mass of the dust

(including the lead), and the mass of the

lead alone. Concentration is calculated

by dividing the mass of the lead by the

total mass of the dust.

Ideally, EPA would favor the use of

both loading and concentration data to

characterize hazards and to identify

appropriate response actions. Two

examples help illustrate the value of

using two measures. In the first

example, a risk assessor finds high dustlead loadings both in house A and in

house B. Dust-lead concentration is high

in house A, but low in house B. Without

the concentration data, the risk assessor

would treat both houses the same. With

the concentration data, the risk assessor

would be able to conclude that house A,

with the high dust-lead concentration,

has an on-going source of lead that

needs to be identified and controlled. In

house B, high loading combined with

low concentration may indicate the

presence of excessive dust that could be

addressed through routine

housecleaning. This example shows

how the additional information

provided by the concentration data

allows the risk assessor to differentiate

between two residences that have

similar dust-lead loadings.

In the second example, a risk assessor

finds high dust concentrations in both

house X and house Y; the dust-lead

loadings are high in X and low in Y. The

concentration data suggest the presence

of an on-going source of lead that

should be identified and addressed. The

loading data, however, indicate that

only house X currently has a dust-lead

hazard. Cleaning, the recommended

control measure for dust-lead hazards,

would likely be an effective risk

reduction intervention in house X but

probably would not be necessary at

present in house Y. This example shows

how the additional information

provided by dust-lead loading data

allows the risk assessor to differentiate

between two houses that have similar

dust-lead concentrations.

Although EPA acknowledges that

both loading and concentration data

would be valuable to a risk assessor, the

Agency recognizes that setting standards

based on both measures might impede

implementation of hazard evaluation on

a large scale (i.e., in the nation’s

housing). Currently, wipe sampling is

the method that most risk assessors use.

In contrast, few risk assessors are skilled

in vacuum sampling (the method

required for obtaining concentration

data). Furthermore, vacuum samples

require significantly more time to

collect because the equipment needs to

be cleaned between samples, resulting

in higher costs for risk assessments.

EPA, therefore, believes that a standard

based on loading alone is more

workable than a standard that uses both

measures. For those risk assessors that

use vacuum sampling or other methods

of dust sampling, the Agency is

planning to provide guidance on the use

and interpretation of concentration data.

2. Surfaces. To date, Federal, State,

and local agencies have traditionally

tested for the presence of lead in dust

on three horizontal surfaces: uncarpeted

floors, interior window sills, and

window troughs. The HUD Guidelines

provide clearance levels for these three

surfaces to evaluate post-abatement

cleanup. EPA included these clearance

levels in its 1994 guidance on leadbased paint hazards. In addition, 25

States currently have, are revising, or

are promulgating standards for floors,

sills, and troughs. The State standards

are largely based on the HUD Guidelines

and EPA’s guidance (Ref. 97).

Although Title IV does not explicitly

require it as part of the TSCA section

403 rule, EPA had to determine for

which surfaces it would propose dustlead hazard standards. EPA considered

several factors in its decision. First, the

Agency wanted to include surfaces that

would enable risk assessors to

adequately characterize risk. Second, it

wanted to minimize the amount and

complexity of sampling required in

order to reduce the cost of risk

assessments. Third, EPA did not want to

deviate significantly from current

approaches unless there was adequate

justification.

Analyses performed by the Agency

show that the dust on floors, sills, and

troughs are highly correlated (Refs. 98

and 99). Of the three surfaces, however,

the scientific literature suggests that

floor dust-lead loadings are the dustlead measure most relevant to

childhood lead exposure. The child

plays on the floor, thereby coming in

contact with any settled dust containing

lead. Lead dust loadings on sills and

troughs are also significant measures but

explain less of the variation in bloodlead concentrations (Ref. 100). For some

data sets, lead dust loadings on sills are

a better predictor of blood-lead

concentrations than lead-dust loadings

in troughs, while the opposite is true for

other data sets (Ref. 101). In addition,

sills and troughs are themselves highly

correlated (Ref. 102).

Based on these data and analyses, the

Agency has determined that standards

should be proposed for floors and either

sills or troughs. Proposing standards

both for sills and troughs does not

improve a risk assessor’s ability to
30336 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

characterize risk sufficiently to justify

the additional expense for sampling and

analysis of both surfaces. EPA has

decided to propose dust standards for

sills but not troughs for two reasons.

First, sills are easier to sample than

troughs. Second, lead in troughs may be

caused by direct deposits from exterior

sources and therefore be less

representative of typical interior levels

than lead on sills. The Agency wishes

to note that this approach is not

intended to imply indifference to dustlead levels in troughs. In fact, EPA is

including a dust-lead clearance standard

for troughs (discussed in Unit VIII. of

this preamble) to ensure that troughs are

adequately cleaned as part of a dust

cleaning intervention.

EPA recognizes that its proposal not

to establish dust levels for window

troughs represents a departure from the

interim guidance. That guidance,

however, did not attempt to identify

risk-based dust-lead levels. Rather, it

adopted the HUD clearance levels for

floors, window sills, and window

troughs and suggested that they be used

to identify ‘‘hazards’’ until the Agency

was able to assess the risks from dustlead on the various surfaces. Today’s

proposal is based upon these new

analyses and presents standards for

those surfaces that appear to adequately

characterize a child’s exposure to dust,

namely floors and interior window sills.

The EPA requests comment on this

difference. In particular, EPA requests

comments on the impact of not having

window trough dust levels on the

accuracy, complexity, and cost of risk

assessments. EPA also requests any new

data or analysis concerning the

relationships between dust on floors,

sills, and troughs and childhood bloodlead concentrations that could help the

Agency in setting hazard standards for

window troughs.

3. Carpeted floors. Today’s proposal

does not include dust standards

(contamination, hazard, or clearance) for

carpeted floors. EPA made this decision

because the Agency is unaware of

adequate data that could be used to

establish a statistical relationship

between dust lead on carpeted floors

and children’s blood-lead

concentrations. In the absence of a

statistical relationship between

children’s blood-lead concentrations

and dust lead on carpeted floors, EPA

cannot estimate the level of risk and risk

reduction that would be associated with

various levels of dust-lead in carpeted

floors. The Agency, therefore, is unable

to select hazard standards that meet the

statutory and policy criteria.

Furthermore, EPA does not have

adequate data on the effectiveness of

carpet cleaning that would be needed to

establish a dust clearance level for

carpeted floors. When the data

necessary to establish dust standards on

carpeted floors become available, EPA

plans to analyze them expeditiously and

amend the regulations being proposed

today to add standards for carpeted

floors.

Because many residences built prior

to 1978 have carpeted floors, EPA

recognizes that the lack of standard for

carpeted floors is a significant limitation

on today’s proposal. The Agency is

therefore requesting comment on the

impact of not including standards for

carpeted floors. EPA would also be

interested in any information or data

that would help it establish such

standards.

4. Emergency dust level. During the

regulatory development process, several

interested parties urged EPA to establish

an emergency dust level as part of the

TSCA section 403 rule (Ref. 13). Two

purposes for an emergency level have

been articulated. First, this level could

be used to help property owners and

other decision-makers set priorities for

implementing hazard control

interventions. Second, an emergency

dust level could be used by local public

health authorities to recommend or

require specific drastic and immediate

actions, such as removal of a child or

immediate environmental intervention

where dust levels exceeded the

emergency threshold.

EPA believes that, while these goals

are worthwhile, an emergency dust level

is not needed either for priority-setting

or for mandating specific actions.

Priorities for intervention should be

based on the ‘‘worst-first’’ approach

where residences with the highest levels

of lead are targeted for earliest response

action. Furthermore, because response

actions should be taken in all houses

with hazards, EPA does not believe that

its national program should establish a

further priority for action. Such

priorities should vary by location,

occupants, housing availability, and

other local factors.

With respect to mandating specific

drastic and immediate actions, EPA

believes that such a response to a leadbased paint hazard would be

appropriate if exposure to very high

levels of lead in dust presents an acute

health risk, and drastic and immediate

action is the only way to prevent further

harm to the health of resident children.

Although EPA is concerned about

continuous exposure to very high levels

of lead in dust, health threats in the

United States today usually occur due to

chronic rather than acute exposure to

dust. In addition, drastic action should

be taken in response to other important

findings, such as an elevated child

blood-lead concentration. The dust

hazard standard should be sufficient for

inducing prompt action by property

owners or other decision-makers and

providing adequate protection to child

occupants.

In the event that EPA obtains

information justifying the need for an

emergency standard, the Agency has

explored several approaches for setting

an emergency dust standard. Under one

approach, EPA would derive an

emergency standard by applying a

multiplier (e.g., 10) to the dust-lead

hazard level. Although this approach is

easy to understand, there is no direct

link to severe human health risk. The

second approach bases the emergency

standard on dust levels found in the

homes of children who have received

medical treatment for lead poisoning.

EPA believes that the second approach

would be preferable because the level

would be associated with exposure and

risk. It has, however, several

disadvantages. Many cases of severe

lead poisoning result from ingestion of

paint chips and not necessarily from

dust ingestion (Ref. 95). In addition,

dust measurements may have been

obtained weeks or months after the

blood-lead concentration was measured

and may not reflect dust-lead levels that

were present when the exposure

occurred. For these reasons, the

Agency’s attempts to develop

emergency dust levels using the second

approach have not been successful.

Thus, EPA lacks sufficient data to

associate levels of lead in dust with

specific cases of medically-managed

lead poisoning. Nevertheless, EPA

believes that this approach is the best

currently available for setting an

emergency dust-lead level.

The Agency is seeking comment on

the issue of an emergency dust standard.

The Agency is interested in comments

concerning the need for an emergency

dust standard, given the ready

availability of blood-lead data. The

Agency also seeks comments on

whether and how an emergency

standard would be used, including

whether immediate responses are

needed because lead from dust usually

causes harm through chronic rather than

acute exposures. In addition, EPA

requests any data, analysis, or approach

that would help the Agency set an

appropriate emergency standard if the

need for such a standard could be

justified.

C. Soil Issues

1. Dual standards for soil-lead level of

concern. During the Dialogue Process,
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30337

several interested parties suggested that

EPA should establish two standards for

soil-lead level of concern: a more

stringent standard for ‘‘play areas’’ and

a less stringent standard for other areas

in a residential yard (Ref. 15). This

suggestion was based on the hypothesis

that there is less contact between

children and the soil in ‘‘non-play

areas,’’ resulting in lower exposure and

risk. Proponents of this suggestion also

cited EPA’s July 14, 1994 guidance

which established a separate advisory

level for soils on non-residential

property and where use by children is

less likely. EPA wishes to note that the

separate advisory level (2,000 ppm)

presented in the 1994 guidance is

intended for use at non-residential

property and that the more stringent

level (400 ppm) applies to all residential

property, including ‘‘non-play areas.’’

The parties that proposed this option

expressed two concerns about a single,

more stringent standard for soil-lead

level of concern applying to the whole

yard. First, response costs would

increase because interim controls (i.e.,

soil cover), the recommended response

for the lower tier soil level in the

guidance, would have to be applied to

larger areas. Second, because it may not

be feasible to install and maintain soil

cover, property owners would have to

perform full soil abatement, the

response recommended for soil-lead

hazards in order to provide adequate

protection.

EPA rejected proposing separate soillead levels of concern for ‘‘play areas’’

and ‘‘non-play areas’’ on residential

property for two reasons. First, the cost

concern is based on this option because

it is based on an incorrect interpretation

of soil-lead level of concern. As noted

in Unit II. of this preamble, the presence

of a soil-lead level of concern does not

trigger any regulatory requirements or

legal obligation. The soil-lead level of

concern is a risk communication tool. It

is, therefore, appropriate that owners

and occupants be aware of any soil on

property where the lead concentration

exceeds this level regardless of its

location. If owners and occupants are

aware of the presence of soil-lead level

of concern, they can take actions to

reduce exposure to children. Such

actions can include applying soil cover

and preventing children from playing in

areas of a yard where lead levels equal

or exceed the level of concern.

Second, EPA believes that it is

infeasible to distinguish between ‘‘play

areas’’ and ‘‘non-play areas’’ in many

yards. Indicators of where children play,

such as playground equipment, are not

always present. In the Rochester study,

‘‘play areas’’ could not be identified at

more than half the residences in the

data set (Ref. 20). Even when such

equipment is present, children’s

outdoor activity is not necessarily

limited to that location. In addition,

play patterns may change when a new

family assumes occupancy following

turnover of a residence. Nevertheless,

the Agency recognizes that, at some

residences, direct exposure to soil

occurs mainly around play equipment.

EPA believes, however, that it is more

appropriate to address this issue in its

sampling guidance by providing advice

to risk assessors on where to collect soil

samples. This issue is discussed further

in Unit VII. of this preamble.

In light of the interest expressed by

some stakeholders in a separate level of

concern for ‘‘play areas,’’ EPA is seeking

public comment on this issue. In

particular, the Agency would like input

on (1) a workable approach for

identifying ‘‘play areas’’ that addresses

the problems discussed above and (2)

the technical basis for establishing a

separate soil-lead level of concern. The

available data and analytical tools

enable the Agency to assess risk from

soil on residential property but not in

specific parts of a yard. EPA would also

like the public to comment on whether

a separate level of concern for ‘‘play

areas’’ would be necessary if the soillead level of concern appears only in

guidance and not in the regulation.

Another interested party suggested

that the standard for soil-lead level of

concern should apply to all ‘‘play areas’’

and to ‘‘non-play areas’’ only where lead

levels in household dust continuously

exceed the dust hazard standard (Ref.

17). This option is predicated on the

assumption that the exposure pathway

for ‘‘non-play areas’’ is track-in lead

which would be measured through

interior dust sampling. If there is no

dust hazard, this party reasoned, then

the lead in the ‘‘non-play area’’ soil does

not present a health threat.

EPA rejected proposing this option for

three reasons. First, EPA is not aware of

any data that link exposure pathways to

location of soil. Therefore, the Agency

cannot assume that track-in

contamination of household dust is the

only pathway associated with ‘‘non-play

area’’ soil. Second, as noted above, EPA

believes that it is infeasible to

distinguish between ‘‘play areas’’ and

‘‘non-play areas’’ in many yards. Third,

the proposed dust standards are lead

loading standards, which reflect a

combination of the amount of dust

present and the concentration of lead in

that dust. The amount of dust on an

interior surface at any particular time

can be extremely variable and can

depend upon cleaning procedures used

in a residence and the length of time

between cleaning and the collection of

the dust sample. Also, the rate of soil

entry into the home can vary depending

upon such factors as the use of doormats

and residents’ preferences regarding

leaving windows open. Given these

variables, the Agency does not believe

that a low interior dust-lead loading

measurement at the time of a risk

assessment could reasonably ensure that

soil in any specific area of a yard

(including ‘‘non-play areas’’) does not

present a risk of concern to children.

2. De minimis area of bare soil. The

definition of lead-contaminated soil in

section 401 refers to bare soil which is

not defined by the statute. Bare soil, as

defined by HUD in its proposed

regulations under sections 1012/1013 of

Title X (61 FR 29206, June 7, 1996) is

‘‘soil not covered by grass, sod, or other

live ground covers, or by wood chips,

gravel, artificial turf, or similar covering.

Bare soil includes sand.’’ EPA

considered whether this definition is

sufficient for the TSCA section 403 rule.

Specifically, the Agency considered

whether the rule should include a

minimum (i.e., de minimis) area of bare

soil as part of the lead hazard criteria.

The inclusion of a de minimis area of

bare soil is based on two assumptions.

First, there is a relationship between the

amount of soil cover and exposure to

lead in the soil. In yards with very small

amounts of bare soil, it is presumed that

exposure would be low. Second, a de

minimis value would help target

resources by eliminating the need to

evaluate soil or respond to

contamination or hazards for properties

where there is only a small amount of

bare soil. For example, the HUD

Guidelines instruct risk assessors to

sample yards that have at least 9 square

feet of bare soil, with no de minimis in

the ‘‘play area’’ (Ref. 11).

EPA considered three options for a

bare soil de minimis area. Under the

first option, EPA would adopt the de

minimis area from the HUD Guidelines.

Although, this approach is consistent

with existing guidance, it would require

risk assessors to measure the size of

individual patches of bare soil. It also

does not account for differences in lot

size. Under the second approach, EPA

would define the de minimis in terms of

bare soil as a percent of the whole yard.

The risk assessor would measure the

percentage of bare soil using a specified

technique (e.g., the line transect method

used by soil conservationists to assess

the erosion potential of cropland soil)

(Ref. 103). This option was designed to

simplify the process of measuring the

area of bareness and to account for

differences in yard size. Under the third
30338 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

option, EPA would not include a de

minimis area of bare soil in the

proposed regulations.

EPA decided not to include a de

minimis area for bare soil because the

disadvantages of each of the two

approaches for establishing a de

minimis outweighed the advantages.

The de minimis used in the HUD

Guidelines does not account for

differences in yard size; 9 ft2 outside of

the ‘‘play area’’ may be insignificant in

a suburban yard but large for the back

yard of an urban row house. Although

a percentage-based de minimis would

account for different yard sizes, EPA has

no analysis or data that relate the

amount of bare soil to risk and,

therefore, no basis upon which to select

the de minimis. Furthermore, there is no

existing government or consensus

percentage-based standard that EPA

could adopt.

EPA also believes that a de minimis

area of bare soil provides little benefit.

First, information provided by an

experienced risk assessor suggests that

very few properties would be excluded

using the de minimis in the HUD

Guidelines (Ref. 104). Second, the

incremental cost of including soil

testing in a risk assessment is small.

Third, if a soil-lead hazard is present,

the property owner or other decisionmaker should take action to control the

hazard and this action should address

all soil where lead levels exceed the

hazard standard whether or not it is

bare.

3. Covered soil. Although Title IV of

TSCA restricts the standard for soil-lead

hazards to bare soil, EPA is concerned

that the presence of soil cover, such as

grass, may not reduce exposure to lead

sufficiently. Consequently, it may be

prudent to test covered soil to determine

whether a soil-lead hazard exists.

The Agency, therefore, recommends

that covered soil be tested in cases

where the risk assessor has reason to

believe that the level of lead in soil may

constitute a soil-lead hazard. Factors

that the risk assessor should consider

include high soil-lead levels in bare

sections of the yard where soil sampling

was conducted, the presence of high

dust-lead levels in a home that has no

lead-based paint, the presence of

children with elevated blood-lead levels

in the community, high soil-lead levels

in neighboring yards, the presence of

nearby industrial sources, the presence

of a nearby steel structure such as a

bridge or highway overpass, and the

past use of the property. It is important

to note that testing of covered soil is

only a recommendation. The standards

being proposed under TSCA section 403

do not apply to covered soil, and the

testing of covered soil is not required by

the regulations promulgated under

authority of TSCA section 402 at 40 CFR

745.227(d) as amended by today’s

proposal.

4. Soil-lead level of concern standard

becoming de facto hazard standard.

Interested parties expressed concern

about the potential confusion over the

two standards for soil. Specifically,

some parties feared that the standard for

soil-lead level of concern could become

the de facto hazard standard for soil,

leading to soil abatement at millions of

homes.

EPA believes, however, that there is

no basis for this concern. First, as

proposed in today’s action, the level of

concern will appear only in guidance,

not in the rule.

Second, the Agency will clearly

explain the differences between the two

levels in its public outreach documents

and education efforts. The two

standards are based on different criteria

and have different purposes. The level

of concern is a tool to communicate risk

and is based on an individual child

having a one to five percent probability

of equaling or exceeding a blood-lead

concentration of 10 μg/dl. Thus, EPA

believes that soils with lead levels that

exceed the level of concern present a

level of risk to children of sufficient

concern that a variety of actions should

be considered to reduce exposure (e.g.,

soil cover, door mats, hand and toy

washing). The standard for a soil-lead

hazard, in contrast, is based on greater

certainty regarding probability of harm.

The presence of a hazard indicates that

the cost of intensive controls (e.g., soil

removal) is commensurate with the

level of risk reduction that could be

achieved.

Third, EPA’s 1994 guidance on leadbased paint hazards contains multiple

levels for soil, and yet there is no

evidence that the public thinks that

abatement is the recommended action at

400 ppm, the lower level in the

guidance.

D. Sample Collection and Analysis

Numerical standards for lead in paint,

dust, and soil have little significance in

the absence of information about how

the samples were collected and

analyzed. In order for the sampling

results to be useful, they must be

reliable. Several conditions have to be

met to consider sampling results

reliable. First, assurances are needed

that the individual who collected the

samples has the appropriate training

and expertise. These individuals must

be familiar with specific requirements

regarding sample collection and

handling. They also must be skilled in

sampling techniques and able to make

critical subjective judgments about the

number and location of samples to

collect. For example, if a risk assessor

fails to measure the area of a dust wipe

sample accurately, the results will be

invalid. Sample handling is also

important because contamination of

samples can invalidate results.

Second, reliability of sampling results

is dependent upon the quality of

laboratory analysis. Laboratories must

adhere to strict quality assurance and

quality control procedures to ensure

that samples are analyzed properly.

These procedures address, among other

things, contamination of samples and

the calibration of laboratory

instruments. Contamination of samples

can have a significant effect on sampling

results and invalidate them. Similarly,

laboratory instruments that are out of

calibration can yield erroneous results.

EPA has several options for ensuring

that the sampling results are reliable

and are comparable to standards. Under

the first option, the Agency could tie the

standards to specific methods. This

approach has the advantage that it uses

methods known to EPA to be reliable

and effective. The major disadvantage is

that it references specific technologies.

As technologies change, the Agency

would have to amend the rule to reflect

these changes. Referencing specific

technologies in a regulation could also

stifle technological innovation.

Alternatively, under a second option,

EPA could adopt an approach that relies

on the performance of its training and

certification program for workers and

contractors and its accreditation

program for laboratories and only

specify the type of samples to be

collected and analyzed. Under this

approach, EPA would assume that

compliance with applicable (i.e.,

Federal, State, Tribal) certification

standards for workers and contractors

and laboratory accreditation through the

National Lead Laboratory Accreditation

Program (NLLAP) ensures that samples

are being collected, handled, and

analyzed in a manner that the results

can be reliably compared to the TSCA

section 403 standards.

EPA has decided to propose tying the

TSCA section 403 standards to risk

assessments conducted according to the

risk assessment work practice standards

found at 40 CFR 745.227. This approach

assures that samples can be reliably

compared to the TSCA section 403

standards while more easily

accommodating technological change

than an approach that references

specific technologies.

Accordingly, EPA is proposing that

the determination of whether in-situ
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30339

paint on a specific component is leadbased shall be made by a certified risk

assessor. If confirmatory laboratory

analysis is necessary, paint chip

samples must be analyzed by a

laboratory recognized by EPA as

proficient for paint analysis. A certified

risk assessor shall determine whether

the paint is in poor condition based on

visual observation. Dust-lead loadings

shall be determined from wipe samples

collected from uncarpeted floors,

interior window sills, and window

troughs by a certified risk assessor and

analyzed by a recognized laboratory.

Soil-lead concentrations shall be

determined from samples collected by a

certified risk assessor and analyzed by

a recognized laboratory.

VI. Requirements for Interpreting

Sampling Results

Under this proposal, to determine

whether lead-based paint hazards are

present at a residence, a risk assessor

would have to compare his/her

measurements and observations to the

hazard and level of concern standards in

this proposed rule. Unit IV. of this

preamble presented the proposed leadbased paint hazard standards.

Regulations promulgated by EPA as part

of the TSCA section 402 training and

certification rule, at 40 CFR 745.227,

establish work practice standards for

risk assessments. Neither the proposed

lead-based paint hazard standards nor

the work practice standards, however,

prescribe how a risk assessor should

compare his/her measurements and

observations with the proposed

standards. Therefore, under authority of

TSCA section 403, EPA is proposing

implementation requirements that will

prescribe how a risk assessor should

compare his/her measurements and

observations to the proposed standards.

This unit of the preamble presents these

proposed requirements and the

Agency’s rationale for its decisions.

A. Paint

According to the regulations at 40

CFR 745.227(d), the risk assessor

identifies and tests all painted surfaces

that are in poor condition (i.e., where

deteriorated paint exceeds the proposed

minimum surface area requirements)

and are determined to have a distinct

painting history to determine whether

the paint is lead-based. EPA is

proposing that results of this sampling

be interpreted in the following manner.

If the testing confirms that the paint is

lead-based, then lead-based paint in

poor condition on that component and

other like components with a similar

painting history is considered

hazardous lead-based paint. This

approach for interpreting the paint

sampling is based on inductive logic; if

the tested component is covered with

lead-based paint, then other like

components with similar painting

histories are covered with lead-based

paint. This approach is consistent with

the HUD Guidelines (Ref. 11).

Risk assessors have the option of

using composite samples rather than

single surface samples. Because

composite samples provide an average

level of lead, low values on some

surfaces may mask the presence of leadbased paint on other surfaces. EPA is,

therefore, proposing to adopt the

approach recommended in the HUD

Guidelines that the standard for leadbased paint (1 mg/cm2 or 0.5 percent by

weight) be divided by the number of

subsamples in the composite (Ref. 11).

For example, if a composite sample

contains five subsamples, the risk

assessor would compare the results to a

standard of 0.2 mg/cm2 or 0.1 percent by

weight. Using this approach, it is

mathematically impossible for the

composite to pass when any single

subsample exceeds the 1 mg/cm2 or 0.5

percent by weight standard for leadbased paint.

It is important to note the composite

paint sampling is essentially a negative

screen. It can be used to demonstrate

that lead-based paint is not present, but

cannot be used to identify which

component has lead-based paint if the

results indicate that lead-based paint is

present. If a composite sample shows

that lead-based paint is present, the risk

assessor would need to take single

surface samples to identify the specific

component(s) that contains lead-based

paint.

B. Dust

1. Single-family housing. Risk

assessors can take two kinds of dust

samples: single surface samples which

yield a result for the specific surface

that was sampled; or composite samples

which yield an average result that

applies to all the surfaces that were

sampled. The interpretation of the

composite sample is straightforward.

The risk assessor compares the result of

the composite sample to the standard

for dust-lead hazards. For single surface

samples and multiple composite

samples, EPA is proposing that the risk

assessor should compare the average,

weighted by the number of subsamples

in each sample, to the standard for dustlead hazard. Under this approach each

single surface sample would have a

weight of one.

The Agency is proposing this

approach because, in the absence of

information on the amount of exposure

that occurs in each location, the average

of single surface samples reasonably

reflects a child’s typical exposure to

lead in dust. This same rationale was

used to design the methodology for the

Agency’s risk analysis. Because average

exposure was used to estimate risk and

choose the standard, it is appropriate to

adopt a consistent approach for

interpretation of dust samples. Using a

weighted average gives the subsamples

in a composite the same weight as single

surface samples and better reflects

average exposure to lead in dust.

EPA recognizes that averaging single

surface samples yields the same

numerical result as a composite sample,

and that this might serve as a

disincentive to conduct single surface

sampling. The Agency believes,

however, that single surface sampling

can yield valuable information that can

help a risk assessor identify sources of

contamination and/or recommend

hazard control strategies that target

particular parts of a home. For example,

single surface sampling may show that

dust-lead levels are well above the

hazard standard in the entry hall of a

home but below the standard elsewhere.

Using the averaging approach, if the

entry hall levels are sufficiently high,

the risk assessor would determine that

there is a dust-lead hazard. By

interpreting the results of the single

surface samples, however, the risk

assessor may be able to determine the

source of the dust contamination is

exterior soil or dust tracked-into the

entry hall and not interior paint. In

addition, the risk assessor may

recommend that dust cleaning be

focused on the entry hall, rather than

the whole house. Whether the

information provided by single surface

samples justifies the cost will be a sitespecific decision.

2. Multi-family housing—a. Dwelling

units. In multi-family housing, a risk

assessor would use the approach for

single-family homes to interpret the

results of sampling in each unit where

samples were collected. There is an

additional issue that must be addressed

in multi-family housing because the

sampling guidance, which is based on

the HUD Guidelines, will provide

several approaches to the risk assessor

for collecting dust samples from a

limited number of units. Because no

dust samples would be collected from

many units under these approaches, the

risk assessor would have to make

assumptions about dust levels in units

that are not sampled. This issue does

not apply to buildings that contain from

two to four units because the risk

assessor would have to collect samples

in all units.
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EPA considered three alternatives for

identifying dust-lead hazards in units

that are not sampled in multi-family

housing.

Option 1. Under option one, the risk

assessor would assume that dust-lead

hazards are present in all unsampled

units if dust-lead hazards are identified

in at least one sampled unit. The risk

assessor would assume that unsampled

units do not contain lead-based paint

hazards only if no dust-lead hazards are

identified in the sampled units. In other

words, a sampled unit where dust-lead

hazards is present would represent all

unsampled units.

Option 2. Under this option, the risk

assessor could refine assumptions about

unsampled units if he/she could

establish a pattern for units that have

dust-lead hazards. For example, testing

results may show that only first floor

units have dust-lead hazards and soillead exceeds the level of concern on the

property. The risk assessor could

conclude from this information that the

dust is being contaminated by the soil

and that this pathway of contamination

applies only to first floor units.

Therefore, only unsampled first floor

units should be assumed to have dustlead hazards.

Option 3. This option applies only to

risk assessors who use random sampling

to select units for testing. The random

sampling protocol is based on the

specification that the number of

sampled units provides 95 percent

confidence that fewer than 5 percent of

all units in the building(s) (or 50 units,

whichever is less) contain dust-lead

hazards if no sampled units have

hazards. Under this option, the risk

assessor could randomly test a sufficient

number of additional units to achieve

the same specification when some units

originally tested have hazards.

The Agency selected the first option

for the proposed rule. Although EPA

recognizes that some unsampled units

would be identified as having dust-lead

hazards even if dust levels in those

units are below the proposed standards,

it is not possible to determine which

unsampled units would have hazards in

the absence of additional data. The only

protective approach, therefore, is to

assume that all unsampled units have

hazards.

Because this approach may identify

some units that do not have dust-lead

hazards as having hazards, EPA would

encourage property owners, who are

faced with this situation, to test the dust

in units that were not initially sampled.

This additional information would

allow the risk assessor to determine

whether dust hazards are actually

present in these units. In light of the

cost of testing and possible cleaning in

a large number of units, the property

owner may consider focusing attention

first on units where young children are

present. Dust testing and cleaning at

other units could wait until unit

turnover.

EPA is not proposing the two other

options because they are unlikely to be

practical or useful. Option 2 would not

be beneficial because, given the

variability of dust loading levels, risk

assessors would probably not be able to

identify patterns of hazard. Option 3

offers little value because there is a high

probability that an additional unit

would fail requiring the risk assessor to

conduct dust testing in even more units.

In the end, the risk assessor would

likely test dust in nearly all the units.

Because the proposed approach for

interpreting the results of dust testing in

multi-family housing is not optimal (i.e.,

it may falsely identify some units as

having dust-lead hazards), the Agency is

seeking comment on this issue.

Specifically, EPA would be interested in

an alternative approach and the data

and rationale used to support an

alternative. The Agency is also

interested in comment on the two

options it considered but rejected.

b. Common areas. The same approach

for interpreting dust samples would

apply to common areas. For common

areas that can be grouped together such

as hallways, the risk assessor could test

dust from a random, targeted, or worstcase sample if there are a sufficient

number of areas. The risk assessor

would assume that dust-lead hazards

are present in the unsampled common

areas if a dust-lead hazard is present in

at least one of the sampled common

areas. For common areas that cannot be

grouped together (e.g., entry lobbies,

basement laundry rooms), the risk

assessors would treat each area as a

separate dwelling unit and collect dust

samples from all such areas. The risk

assessor would interpret the dust

sample results for each area according to

the requirements for single-family

homes described above.

C. Soil

EPA is proposing that the

interpretation of soil samples would use

techniques similar to those employed

for the interpretation of dust samples.

The risk assessor would compare the

average concentration of the dripline

and mid-yard composites to the soillead hazard standard. If the risk assessor

collects more than one dripline or midyard composite sample, he/she would

first compute the average concentration

in the dripline and/or in the mid-yard

and then compute the average of the

dripline and mid-yard concentrations.

The approach of using the average

concentration is based on the rationale

stated above for the interpretation of

dust samples. Risk assessors would use

the above approach for each building in

a multi-family housing development

and compare the average for all

buildings to the soil-lead hazard

standard.

The use of sampling data, however,

should not be limited to determining

whether a hazard exists. Soil samples

can provide valuable information to the

risk assessor about the location and

extent of soil contamination, which can

help the assessor design a targeted

control strategy. For example, a risk

assessor may determine, based on the

average of the dripline composite

sample and mid-yard composite sample,

that a yard exceeds the soil-lead hazard

standard. The individual composite

samples may show, however, that the

soil in the dripline is above the hazard

standard but the mid-yard soil is not.

This information enables the risk

assessor to design a strategy that focuses

controls for soil solely in the dripline.

Examining the results of individual

composite samples would be especially

valuable in a multi-family housing

development where focusing soil

intervention on relatively small areas

can reduce the costs of intervention

significantly.

In addition, as EPA will detail in the

guidance document on using the hazard

standards, the Agency recommends that

when the remediation strategy is

developed, that areas with highest lead

levels be addressed first. For example, if

dripline soil is 3,500 ppm and mid-yard

soil is 500 ppm (i.e., yard-wide average

of 2,000 ppm), the strategy to reduce

average levels below 2,000 ppm should

rely first on removing the highly

contaminated soil at the dripline rather

than on covering the moderately

contaminated soil at the mid-yard.

VII. Amendments to TSCA Section 402

Regulations

This unit of the preamble presents

proposed amendments to the work

practice standards for risk assessments

and abatements promulgated under the

authority of TSCA section 402 at 40 CFR

745.227 along with EPA’s rationale for

its decisions. These amendments would

include the establishment of dust

clearance standards, management

controls for soil removed during an

abatement, and changes to existing dust

and soil sampling provisions. EPA did

not include clearance standards as part

of the original TSCA section 402 rule

because the Agency thought that it was

more appropriate to establish these
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30341

standards together with the TSCA

section 403 hazard standards.

Amendments to the sampling provisions

are necessary because the work practice

standards were developed prior to the

TSCA section 403 regulations. Therefore

several previously developed sampling

provisions are not compatible with the

hazard standards proposed in this rule.

EPA is proposing management controls

for soil removed during an abatement

because of concern that soil removed

from one yard could be disposed of in

the yard of another residential property

or child-occupied facility.

When EPA finalizes the regulations

being proposed today, the Agency will

also issue conforming amendments to

the section 402 regulations to ensure

consistency in terminology between the

regulations. These conforming

amendments will most likely focus on

references to the terms leadcontaminated dust and leadcontaminated soil which are not

included in today’s proposal.

A. Clearance Standards

Under the authority of section 402 of

TSCA, EPA is proposing clearance

standards for dust in today’s proposed

rule. Clearance standards are used by

certified individuals to evaluate the

adequacy of the cleanup performed in

residences at the completion of

abatement. According to the practices

prescribed at 40 CFR 745.227, a certified

risk assessor or inspector must collect

dust samples and have them analyzed

by an accredited laboratory following

the cleanup to assure that the cleanup

reduced dust-lead levels to the levels

prescribed in today’s proposal. If the

clearance levels are not met, the cleanup

and testing process must be repeated

until the clearance standards are met.

Although clearance testing is not

required following implementation of

interim controls (e.g., paint repair), the

Agency strongly recommends such

testing to ensure that the residence has

been adequately cleaned.

TSCA section 402 establishes three

criteria for performing lead-based paint

activities: reliability, effectiveness, and

safety. EPA is reluctant to propose an

approach that mandates a specific

technology. In fact, the Agency wants to

promote technological innovation that

could result in less costly products and

practices that are equally or more

effective.

Consequently, EPA is proposing that

these criteria should apply to numerical

dust lead clearance levels. Under this

approach, the Agency would be

establishing standards that are

achievable using products and methods

known to be reliable and effective.

Specifically, EPA has decided to base

the clearance standards on the

performance of the cleanup method

recommended in the HUD Guidelines

which is currently considered state of

the art. This method involves a

combination of a wet wash with an allpurpose or lead-specific cleaner and

HEPA vacuuming. Although clearance

standards are based on dust-lead levels

achievable using this method, the

standard does not require this method.

Any cleanup method would be

satisfactory as long as the clearance

standard is met. This approach ensures

that the cleanup was reliable and

effective while providing an incentive

for entrepreneurs to develop less costly

technologies that can meet the standard.

EPA considers safety, for purposes of

clearance, to be a level of lead in dust

that is a associated with the risk level

of concern (i.e., a one to five percent

probability that a child will have a

blood-lead concentration equal to or

exceeding 10 μg/dl). As is the case with

a clearance standard that is effective and

reliable, a safe clearance standard would

not prescribe a specific cleaning

technology; any technology would be

acceptable as long as it is able to reduce

dust-lead loadings to ‘‘safe’’ levels.

The clearance standards must also be

evaluated within the broader context of

Title X and its purposes. In particular,

EPA must select clearance standards

that are compatible with the

development of a workable framework

for lead-based paint hazard evaluation

and reduction.

1. Clearance standard for floors and

sills. The available field data

documenting experience with the

cleaning protocol recommended in the

HUD Guidelines do not identify obvious

candidates for clearance standards (Ref.

105). Instead, use of the protocol yields

a range of dust loadings. It should be

noted that these data were collected

under the controlled conditions

associated with field studies. In

practice, higher post-cleanup dust-lead

levels should be expected.

EPA’s analysis of data from HUD

demonstration projects and five State

and local programs shows that the

median dust-lead loading for floors after

the first clearance test was 25 μg/ft2 with

a 90th percentile loading of 187 μg/ft2.

The median dust-lead loading for

interior window sills was 33 μg/ft2 and

the 90th percentile was 475 μg/ft2.

These data show that there is significant

overlap among the dust-lead loadings

achievable using the HUD cleaning

protocol and the levels of lead in dust

associated with the risk level of concern

and the dust-lead hazard level.

EPA has decided, therefore, to

propose clearance standards that are the

same as the dust-lead hazard standard,

50 μg/ft2 for uncarpeted floors and 250

μg/ft2 interior window sills. This

decision as based primarily on choosing

standards that are consistent with the

available data and that are as easy as

possible to understand and implement.

The other option considered was to

select a clearance standard that is lower

than the hazard standard.

EPA is concerned that separate

clearance and hazard standards would

be difficult for property owners and

other decision-makers to understand.

Especially troublesome are post-cleanup

dust loadings that exceed clearance

standard but not the hazard standard.

Recleaning would be required in

response to the clearance test, but no

action would be indicated if the same

loading was measured prior to

intervention. Although this situation

would be technically justifiable because

hazard and clearance standards serve

different purposes (indicator of risk vs.

indicator of cleaning adequacy), it may

seem to be inconsistent to owners and

other decision-makers and make the

standards difficult to understand. This

situation is avoided by having both the

hazard and clearance standards set at

the same dust-lead loading.

Another argument that has been made

to support separate hazard and

clearance standards is to provide a

margin that allows for reaccumulation

of lead in dust following the cleanup. In

the absence of this margin, there is a

concern that a residence could have a

dust-lead hazard soon after hazard

control interventions were performed.

The field data show, however, that in

most circumstances reaccumulation will

not result in the immediate

reappearance of a dust-lead hazard

because the majority of residences

would be cleaned to levels well below

clearance (Ref. 105).

2. Clearance standard for window

troughs. The Agency considered two

alternatives for window trough

clearance standards: 800 μg/ft2, the

standard in the HUD Guidelines; and a

‘‘no-visible’’ dust standard. The first

option has the advantage that it is

consistent with existing practice,

ensures that troughs will be adequately

cleaned, and meets the statutory criteria.

The ‘‘no-visible’’ clearance standard

does not require follow-up dust testing

of the trough. Although, data suggest

that troughs have been adequately

cleaned if there is no visible dust and

debris in the window troughs and the

clearance standards for uncarpeted

floors and interior window sills are met,

these data were collected when there
30342 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

was a trough clearance standard that

had to be met (Ref. 105). In the absence

of a clearance standard, there is no

assurance that troughs would be cleaned

as well. EPA, therefore, has decided to

propose adopting the existing HUD

clearance level for troughs. Although

this option would require trough

sampling, it is expected that the

incremental cost for clearance sampling

would be $5 to $10 depending on the

number of composite samples taken.

3. Interpretation of dust clearance

samples. The work practice standards at

40 CFR 745.227 already include a

provision for interpreting dust clearance

samples, which states that if a clearance

sample fails, all components

represented by the failed sample shall

be recleaned. This provision, however,

does not differentiate between single

surface samples and composite samples.

Because composite samples provide an

average level of lead, low values on

some surfaces may mask the presence of

lead levels that exceed clearance

standards on other surfaces. In fact,

EPA’s analysis of empirical clearance

testing data shows that there is a 57

percent chance that a composite sample

would pass clearance even if any

individual subsample would have failed

the clearance test using the clearance

standard (i.e., false passing) (Ref. 105).

False passing introduces the possibility

that a post-abatement cleanup would be

judged to be adequate when, in fact, it

was not. There are no ‘‘false failures’’ for

composite samples under this approach

(Ref. 105). Consequently, EPA

developed and analyzed two options for

amending the requirements at 40 CFR

745.227(e)(8) to include separate

provisions for interpreting the results of

composite dust clearance samples.

Option 1. The first option is the most

stringent. Under this option, the risk

assessor would divide the clearance

standard by the number of subsamples

in the composite. For example, if a

composite floor sample contained four

subsamples, the risk assessor would

compare the loading from the composite

sample to 12.5 μg/ft2 (i.e., the floor

clearance standard divided by four).

This approach is analogous to that being

proposed above for interpretation of

composite paint samples. Using this

approach, it is mathematically

impossible for the composite to pass

when any single subsample exceeds the

1 mg/cm2 or 0.5 percent by weight

standard for lead-based paint. It would,

however, introduce the possibility of a

composite sample failing clearance even

if all the subsamples would have passed

clearance individually (i.e., false

failure), leading to additional clean up

activities that may not be necessary.

EPA’s analysis of the empirical data

shows that there is an 18 percent chance

of having a false failure (Ref. 105).

Option 2. The second option is a

middle ground approach between using

the clearance standard for single

surfaces samples and option one. Under

this option, the risk assessor would

compare the result of composite dust

clearance samples to twice the value of

the clearance level calculated in option

one. That is, the risk assessor would

compare the composite sample lead

loading to 2CS/n, where CS is the

clearance standard for single surface

samples and n is the number of subsamples in the composite. EPA’s

analysis of the empirical data shows

that under this option there is a 5

percent chance of failing clearance

when all subsamples pass individually

and a 22 percent chance of passing

clearance when at least one of the

subsamples would have failed

clearance.

EPA selected option one for the

proposed amendment because it

provides the best balance of safety,

effectiveness, and reliability. The false

failure error probability for option one,

18 percent, is lower than the false

passing probability (57 percent) using

single surface clearance standards.

Moving from option one to option two,

the improvement in false failure

probability, which declines from 18

percent to 5 percent, is smaller than the

decline in false passing probability,

which increases from zero percent

under option one to 22 percent under

option 2. The Agency specifically asks

for comment on this approach.

B. Amendments to Sampling

Requirements

1. Risk assessment and clearance dust

sampling. As stated above, 40 CFR

745.227(d) requires risk assessors to

collect dust samples from windows

without specifying whether the samples

should be collected from window sills,

window troughs, or other surfaces. EPA

adopted this general approach when

promulgating the 402 regulation because

the TSCA section 403 standards, which

would specify hazard standards for only

certain surfaces, were not yet in place.

In the absence of standards, the decision

on where to collect samples was left to

risk assessors, based on their experience

and training.

Because EPA is now proposing dustlead hazard standards for window sills

but not for troughs, risk assessors would

only need to collect dust samples from

window sills; dust samples for windows

troughs would not be necessary. EPA,

therefore, is proposing to amend 40 CFR

745.227(d)(5) and 40 CFR 745.227(d)(6)

to specify that dust samples be collected

from window sills for risk assessment.

Because EPA is proposing clearance

standards for window sills and troughs,

risk assessors would need to collect dust

samples from both surfaces. EPA,

therefore, is proposing to amend 40 CFR

745.227(e)(8)(v)(A) and 40 CFR

745.227(e)(8)(v)(B) to specify that dust

samples be collected from both interior

window sills and window troughs for

clearance sampling.

2. Soil sampling. A third sampling

provision that requires amendent is the

location of soil sampling. Currently, 40

CFR 745.227(d) requires the risk

assessor to collect soil samples from the

dripline and the ‘‘play area.’’ The

rationale for specifying these two

locations was that the ‘‘play area’’ was

most representative of a child’s

exposure to lead in soil and the dripline

represents the worst-case exposure to

lead in soil. Additional review of this

issue during development of today’s

proposal, however, suggests that these

sampling locations should be changed

to the dripline and the middle of the

yard.

EPA is proposing this amendment,

because the Agency believes that, in the

absence of site-specific information

about a child’s play pattern, a child’s

exposure to lead in soil is best reflected

by the average soil-lead level in a yard.

First, it is the Agency’s judgment that it

is not feasible for risk assessors to

improve on this average exposure

assumption for many properties.

Indicators of where children play, such

as playground equipment, are not

always present. Even when such

equipment is present, children’s

outdoor activity is not necessarily

limited to that location. Additionally,

play patterns may change when a new

family assumes occupancy following

sale of a residence, a time when many

risk assessments may occur, due to the

opportunity provided to buyers under

section 1018 of Title X.

Second, the data show that the

average of composite samples taken

from the dripline and the mid-yard

provides a reasonable estimate of yardwide soil-lead levels. Lead

concentrations are often distributed in

predictable patterns, with the largest

differences in lead levels found between

the soil around the building perimeter

(i.e., the dripline) and the mid-yard soil.

For example, the median concentration

in the dripline in the HUD National

Survey is 448 ppm while the mean midyard concentration is 204 ppm (Ref. 8).

Two factors explain this pattern.

Dripline soil may be contaminated by

deteriorating exterior lead-based paint.

For properties that do not have exterior
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30343

lead-based paint, it has been suggested

that exterior wall surfaces capture lead

aerosol particles (from the past

combustion of leaded gasoline), which

in turn wash off and accumulate in the

soils around buildings (Ref. 106).

C. Management Controls for Soil

Under the abatement work practice

standards, there are no management

controls for soil that is removed during

an abatement. At the final Dialogue

Process meeting, stakeholders expressed

concern that this soil could be reused

improperly (e.g., as topsoil at another

residential property) (Ref. 16). EPA

agrees that the lack of management

controls for abated soil is a significant

gap in the regulatory framework. To

respond to this issue, the Agency

identified two options.

Under the first option, EPA would

propose that the reuse of removed soil

as topsoil at another residential property

or child-occupied facility be prohibited.

This option addresses the most

egregious misuse of removed soil but

may not adequately deal with other

potential abuses. The second option

would involve the development of

comprehensive management controls.

Comprehensive controls would ensure

that soil removals are safe, reliable, and

effective. Development of such controls,

however, could further delay the rule.

EPA chose the first option. It

addresses the worst abuse and can be

done without further delaying the rule.

The Agency will examine this issue

further and determine whether more

comprehensive controls are required. If

so, these controls would be proposed as

a separate amendment to the soil

abatement work practice standards. To

assist EPA in its examination of this

issue, EPA is interested in obtaining

comment on the types of practices that

should be prohibited and on the types

of controls that should be considered.

VIII. Effect of TSCA Section 403

Standards on Other Title X Regulations

and Programs

The term ‘‘lead-based paint hazard’’ is

used throughout Title X. As a result,

TSCA section 403 standards will affect

the implementation of other Title X

programs. This unit of the preamble

describes the impact of the proposed

standards on the other Title X programs.

A. HUD Programs

1. HUD grants. Under section 1011 of

Title X, HUD issues grants for the

evaluation and reduction of lead-based

paint hazards in privately owned, lowincome housing. Once today’s proposal

has been promulgated, clearance testing

would have to be conducted following

abatements performed with grant

funding.

2. Requirements for Federally-assisted

or Federally-owned housing. Under

sections 1012 and 1013 of Title X, HUD

is establishing lead-based paint hazard

notification, evaluation, and reduction

requirements for certain pre-1978 HUDassociated and Federally-owned (prior

to sale to the public) housing. The

programs covered by these requirements

range from HUD-owned housing to

single-family insured housing. For

programs where hazard evaluation is

required, the TSCA section 403

standards, when finalized, will provide

criteria to risk assessors for identifying

lead-based paint hazards in residences

covered by these programs. For

programs that require abatement of leadbased paint hazards, the TSCA section

403 standards shall be used to identify

residences that contain lead-based paint

hazards to determine where abatement

will be necessary.

HUD proposed regulations under

1012 and 1013 on June 7, 1996 (61 FR

29170) that reflected EPA’s lead-based

paint hazard guidance. HUD is required

to incorporate the TSCA section 403

standards, or more stringent standards,

directly into its final rule or to crossreference the standards.

3. HUD Guidelines The HUD

Guidelines for the Evaluation and

Control of Lead-Based Paint Hazards in

Housing were developed in 1995 under

section 1017 of Title X. They provide

detailed, comprehensive, technical

information on how to identify leadbased paint hazards posed by paint,

dust, and soil in residential housing and

how to control such hazards safely and

efficiently. Although the TSCA section

403 standards will have no regulatory

impact on the Guidelines, the

Guidelines will be revised periodically

to incorporate new information,

technological advances, and new

Federal regulations, including EPA’s

lead-based paint hazard standards.

Chapter 5 of the Guidelines on risk

assessment would need to be updated to

incorporate the standards for lead-based

paint hazards. For example, the

discussion of the following topics

would need to be revised: hazard levels

for deteriorated paint, dust (for both risk

assessment and screening of dwellings

in good condition), and bare soil; and

interpretation of sampling results. The

clearance standards in Chapter 15 also

would need to be revised to be

consistent with the TSCA section 403

standards.

4. Real estate disclosure requirements.

On March 6, 1996 (61 FR 9064) (FRL–

5347–9), pursuant to section 1018 of

Title X, HUD and EPA jointly issued

regulations requiring sellers or lessors of

most pre-1978 housing to disclose the

presence of known lead-based paint and

lead-based paint hazards and provide

the potential purchaser or lessee with a

copy of the pamphlet, Protect Your

Family from Lead in Your Home. In

addition, sellers must provide a 10–day

period to buyers to conduct a risk

assessment or inspection for the

presence of lead-based paint and leadbased paint hazards. Sellers and lessors

must also include warning language in

sales contracts (24 CFR part 35, subpart

H; 40 CFR part 745, subpart F).

To date, owners have relied on EPA’s

guidance for advice about conditions

that may be considered lead-based paint

hazards. By establishing regulatory

standards for lead-based paint hazards,

the TSCA section 403 rule will provide

criteria for triggering certain disclosure

by property owners. Furthermore,

because the TSCA section 403 standards

will be based on a comprehensive

analysis of the most recent data and

research available, they will offer buyers

and lessees a better tool for interpreting

risk assessment reports provided by

property owners. As part of EPA’s

outreach efforts in this area, the Agency

is planning to provide guidance on how

to use the TSCA section 403 standards

to interpret sampling results in risk

assessment reports. Disclosure of the

presence of lead-based paint is

unaffected by the TSCA section 403

standards.

B. EPA Programs

1. Training, accreditation, and

certification requirements and work

practice standards. Under TSCA section

402(a), EPA issued a regulation on

August 29, 1996 (61 FR 45778), at 40

CFR part 745 requiring individuals

engaged in lead-based paint activities in

target housing and child-occupied

facilities to be trained; these individuals

and contractors engaged in the same

activities to be certified; and training

programs to be accredited. These

regulations also contain work practice

standards for performing lead-based

paint activities, including risk

assessments, taking into account

reliability, effectiveness, and safety.

The most significant impact of the

TSCA section 403 standards on the

training and certification programs

concerns the determination of when

certified workers and contractors are

required to perform abatements.

According to the training and

certification regulations at 40 CFR

745.223, abatement is defined as the

permanent elimination of lead-based

paint hazards, and must be performed

by certified individuals and contractors
30344 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

unless it is performed by the property

owner in an owner-occupied residence

(40 CFR 745.220(b)). By identifying

lead-based paint hazards, the TSCA

section 403 regulations help owners

determine when work needs to be

performed by certified individuals and

contractors.

Today’s action also contains proposed

changes to the TSCA section 402

regulations. These changes include: the

establishment of clearance standards for

dust; amendments related to risk

assessment and clearance sampling for

dust, and sampling for soil; management

controls for abated soil; and

amendments changing the references to

the lead-based paint hazard guidance to

the TSCA section 403 regulations when

final. The final TSCA section 403

regulations and the accompanying

amendments to TSCA section 402 will

necessitate changes to EPA’s model

training curricula in the areas of hazard

standards, related underlying advances

in scientific and technical information,

risk assessment sampling, interpretation

of sampling results, approaches for

hazard control, and clearance standards.

2. State Programs. In conjunction

with the TSCA section 402 regulations

described above, EPA adopted

procedures for States and Indian Tribes

to follow when applying to EPA for

authorization to administer and enforce

a State or Tribal lead-based paint

program (40 CFR 745.324). EPA

considers standards for lead-based paint

hazards and soil-lead level of concern,

dust-lead clearance standards, and

associated requirements for sampling

and interpreting sampling results to be

an integral part of the work practice

standards for risk assessments and

abatements. Therefore, EPA is proposing

amendments to subpart Q that would

require States and Tribes to establish

standards and requirements that are as

protective as the Federal standards

being proposed today.

States and Tribes that apply for

authorization following the date that is

2 years after promulgation of the rule

would have to demonstrate, as part of

their application for program

authorization, that their standards are as

protective as the Federal standards.

Today’s proposed amendment would

require all other States and Tribes that

wish to retain authorization to

demonstrate to EPA’s satisfaction that

their standards are as protective as the

Federal standards within 2 years of the

promulgation of the rule. To minimize

the reporting burden, these States and

Tribes would apply to retain

authorization as part of their reports to

EPA in accordance with 40 CFR

745.324(h).

As a general matter, States and Tribes

that apply to obtain or retain

authorization that incorporate the same

standards or standards that are more

stringent than the Federal standards will

meet the ‘‘as protective as’’ criteria.

States and Indian Tribes that

incorporate less stringent standards

would have to provide analytical

support and other documentation

demonstrating that their standards are

‘‘as protective as’’ the Federal standards.

For example, a State or Tribe may

demonstrate that a higher soil-lead

hazard standard could be ‘‘as protective

as’’ the Federal standard because most

of the lead found in the soil is less

bioavailable than lead considered by the

Agency. EPA plans to develop specific

guidance on the types of analysis and

documentation that a State or Tribe

would need to provide to make such a

demonstration.

3. Real estate disclosure requirements.

EPA and HUD jointly developed these

requirements. The effects of the TSCA

section 403 lead hazard standards on

real estate disclosure requirements were

discussed previously in reference to the

HUD programs.

4. Public outreach programs. EPA, in

conjunction with HUD and other

Federal agencies, has developed various

public education programs, such as the

National Lead Information Center and

outreach campaigns targeting housing

providers, health care professionals, the

media, persons involved in real estate

transactions, and the general public.

When promulgated, the TSCA section

403 standards will play a significant

role in this public education.

Information regarding these standards

will communicate the Agency’s best

judgment concerning the identification

of lead-based paint hazards to property

owners, State and local officials,

tenants, and other decision-makers. To

assist in this education, the Agency will

be developing materials specifically

addressing the TSCA section 403

standards, including a fact sheet and

questions and answers bulletin. In

addition, some existing outreach

materials will be modified to discuss the

TSCA section 403 standards or to

reference materials with such

discussion.

IX. Relationship of TSCA Section 403

Standards to Other EPA Programs

Because lead exposures occur through

all media, a variety of EPA programs, in

addition to the TSCA Title IV program,

address residential lead contamination

and lead in soil. The Resource

Conservation and Recovery Act (RCRA)

regulates as hazardous certain wastes

containing lead, including some wastes

that may be generated during lead-based

paint activities. The Comprehensive

Environmental Response,

Compensation, and Liability Act

(CERCLA or Superfund) and the RCRA

corrective action programs clean up lead

released into the environment. EPA’s

Indoor Air program also seeks to reduce

contamination of the indoor

environment by substances including

lead. This unit describes the

relationships between the proposed

TSCA section 403 standards and each of

these EPA programs.

A. RCRA Hazardous Waste

Requirements

Wastes generated by lead-based paint

hazard reduction activities may be

regulated as ‘‘hazardous wastes’’ under

RCRA Subtitle C. Wastes may be

considered hazardous waste by virtue of

being specifically listed as hazardous or

by exhibiting a characteristic of

hazardous waste. Lead-bearing wastes

from lead-based paint activities are not

listed wastes. Such wastes, however,

may exhibit the hazardous

characteristics of toxicity (40 CFR

261.24), corrosivity (40 CFR 261.22), or

ignitability (40 CFR 261.21). They are

unlikely, due to lead content, to exhibit

the other hazardous characteristic of

reactivity (that is, be capable of easily

generating explosive or toxic gas,

especially when mixed with water, or be

unstable and undergo violent change

without detonating).

Under the toxicity characteristic,

wastes or media (e.g., soil) contaminated

with wastes are hazardous for lead if,

after applying the toxicity characteristic

leaching procedure (TCLP) to a sample,

the waste produces an extract with a

concentration of lead equal to or

exceeding 5 milligrams per liter (5

ppm). Corrosive hazardous waste is

waste that has a pH less than or equal

to 2 (highly acidic) or greater than or

equal to 12.5 (highly basic), or that can

corrode steel at a certain rate.

Unneutralized waste from the use of

caustic or acidic paint strippers may be

corrosive hazardous waste. Ignitable

hazardous waste generally includes

liquids with flash points less than 140

°F (60 °C), flammable solids,

compressed gases, and oxidizers. Wastes

generated by the use of certain solvents

for paint stripping may be ignitable

hazardous waste.

When promulgated, TSCA section 403

standards will not affect the

determination of whether wastes or soil

containing lead are hazardous under

RCRA. Moreover, there is no direct

relationship between the approaches

used to identify a TSCA section 403

lead-based paint hazard and a RCRA
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30345

characteristic hazardous waste. The

TSCA section 403 standards are based

on an exposure scenario involving the

ingestion of lead-contaminated dust or

soil by young children. In contrast, the

level at which wastes contaminated

with lead are considered hazardous

under the RCRA toxicity characteristic

is based upon an analysis using a

scenario involving the consumption of

ground water contaminated by waste

constituents leaching from a landfill

receiving municipal waste.

The potential applicability of RCRA

hazardous waste regulations and the

associated compliance costs, however,

have informed the development of the

proposed TSCA section 403 soil-lead

hazard standard. As discussed in Unit

IV. of this preamble, when developing

TSCA regulations, EPA considered both

risk reduction and cost in selecting the

proposed soil-lead hazard standard.

Because the costs of managing

excavated lead-contaminated soil as

hazardous waste are significantly higher

than the cost of managing this material

as non-hazardous waste, identifying this

material as hazardous waste would

approximately double the cost of

abatement and was a factor in the

selection of the proposed standard.

B. CERCLA Response Actions and RCRA

Corrective Actions

Under CERCLA, the Federal

government may undertake or compel

responsible parties to cleanup

hazardous substance releases. Because

lead is a CERCLA hazardous substance,

these response actions may address lead

contamination in soil and other

environmental media. Likewise, soil,

sediment, or other media contaminated

with lead may be considered a RCRA

hazardous waste (as described above)

and RCRA hazardous waste

management facilities undergoing

corrective action may be required to

remediate such contamination. The

CERCLA and RCRA cleanup programs

have similar purposes, but address

different types of sites: whereas RCRA

regulates permitted hazardous waste

treatment, storage, and disposal

facilities, CERCLA generally governs

abandoned or uncontrolled industrial

sites (but may also be applied to

residential or commercial properties).

To assist the regulators responsible for

CERCLA responses and RCRA corrective

actions, EPA has developed soil

screening levels (SSLs) for various

hazardous constituents, including lead.

The SSL for lead is 400 ppm, based on

risk analysis using the IEUBK model

with a residential scenario (Ref. 84). The

SSL is not a cleanup standard. It neither

triggers the need for response actions

nor defines unacceptable levels of soil

contamination. Instead, it helps Federal

and State regulators identify and define

lead-contaminated areas that require

further study.

Where soil-lead concentrations at

CERCLA sites or RCRA corrective action

facilities are below the SSL, no further

response action or study of such

contamination is generally warranted.

Where contaminant concentrations

equal or exceed the SSL, however,

further investigation, but not necessarily

cleanup, is warranted. These further

investigations often involve site

characterization and the application of

the IEUBK model using site-specific

data for sites that include residential

property. Federal and State regulators

use the results of these investigations to

determine the need for remediation and,

if necessary, to analyze remedial options

and establish site-specific preliminary

remediation goals (PRGs) at CERCLA

sites and at RCRA corrective action

facilities.

The TSCA section 403 standards are

defined for largely different purposes

and audiences. Unlike CERCLA

responses and RCRA corrective actions,

residential lead hazard reduction

activities often occur without

government oversight. The TSCA

section 403 standards are intended for

use by any person involved in

identifying and addressing lead-based

paint hazards, including homeowners,

rental property owners, tenants,

contractors, government housing

programs, and Federal, State, and local

regulators. The proposed TSCA section

403 standards are designed to provide

practical advice widely applicable to

residential property. Expensive,

residence-specific investigations would

not be required. Rather, when

promulgated, the standards could be

used for millions of homes throughout

the nation to evaluate properties quickly

at modest cost.

In addition, the criteria used to select

hazard control methods differ under

TSCA section 403, RCRA, and CERCLA.

Under CERCLA, for example, preference

is given to ‘‘treatment [methods] which

permanently and significantly reduce

the volume, toxicity or mobility’’ of the

hazardous constituents regardless of risk

(CERCLA section 121(b)). Likewise,

under RCRA, hazardous waste must be

treated to meet stringent standards prior

to land disposal. TSCA does not have

any similar preferences for permanent

treatment. Furthermore, Title X

recognizes the important role of

temporary control measures (i.e, interim

controls).

In summary, the TSCA section 403

standards should not affect the selection

of cleanup remedies at CERCLA

response actions or RCRA corrective

action facilities. The TSCA section 403

standards are being developed for

different purposes and audiences. They

will provide generic guidance that can

be used at millions of widely varying

sites throughout the nation. Owners of

properties with lead-based paint

hazards should undertake permanent or

interim measures to control these

hazards. In contrast, the site-specific

investigations that occur under CERCLA

and RCRA allow risk and cleanup levels

to be narrowly tailored to the individual

site with a preference for permanent

solutions. Thus, the action levels,

cleanup goals, and remedies selected at

CERCLA and RCRA sites may differ

from those being proposed in today’s

action.

C. Indoor Air Activities

The Indoor Environment Division of

EPA’s Office of Air and Radiation seeks

to reduce indoor air pollution through a

variety of educational and other nonregulatory means. The Indoor Air

Program incorporates lead-based paint

concerns in its outreach to owners and

occupants of residential, public, and

commercial buildings, even though

lead-based paint concerns are not its

primary focus and the inhalation of air

containing lead-contaminated dust is

not the major pathway of childhood

lead exposure. The Indoor Air Program

will reference and discuss section 403

standards in its efforts to help building

owners and occupants properly identify

and respond to lead-based paint hazards

and other indoor air problems.

X. Public Record and Electronic

Submissions

The official record for this proposed

rule has been established under docket

control number OPPTS–62156

(including comments and data

submitted electronically as described

below). A public version of this record,

including printed, paper versions of

electronic comments, which does not

include any information claimed as CBI,

is available for inspection from 12 noon

to 4 p.m., Monday through Friday,

excluding legal holidays. The official

record is located in the TSCA

Nonconfidential Information Center,

Rm. NE-B607, 401 M St., SW.,

Washington, DC. The record now

includes:

1. ‘‘Risk Analysis to Support

Standards for Lead in Paint, Dust, and

Soil,’’ Office of Pollution Prevention

and Toxics.

2. The economic analysis.

3. Materials related to the Dialogue

Process and other public meetings
30346 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

(contained in Dockets OPPTS-62148,

OPPTS-62151, OPPTS-62151A, and

OPPTS-62151B).

4. Support documents, reports, and

published literature cited in this report,

including all the references listed in

Unit XI. of this preamble.

5. Published literature and all other

references cited in all relevant

documents.

Electronic comments can be sent

directly to EPA at

oppt.ncic@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect 5.1/

6.1 or ASCII file format. All comments

and data in electronic form must be

identified by the docket control number

OPPTS–62156. Electronic comments on

this proposed rule may be filed online

at many Federal Depository Libraries.

XI. References

1. U.S. Environmental Protection

Agency. December 1997. Risk Analysis

to Support Standards for Lead in Paint,

Dust, and Soil. Volumes I and II. EPA

747-R-97-006.

2. U.S. Centers for Disease Control

and Prevention. October 1991.

Preventing Lead Poisoning in Young

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3. Lepow, M.L., et al. 1975.

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5. Pirkle, J.L., D.J. Brody, E.W. Gunter,

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7. Brody, D.J., J.L. Pirkle, R.A. Kramer,

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and D.C. Paschal. 1994. ‘‘Blood Lead

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the Third National Health and Nutrition

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8. U.S. Environmental Protection

Agency, Office of Pollution Prevention

and Toxics. April 1995. Report on the

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Housing - Base Report. EPA 747-R-95-

003.

9. U.S. Environmental Protection

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37. Baumann, S., D. Otto, G.

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38. Schwartz, J. and D.A. Otto. 1987.

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39. Bellinger, D.C., A. Leviton, and C.

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40. Dietrich, K.N., K.M. Kraft, and R.

Shukla, et al. 1987b. ‘‘The

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41. Ernhart, C.B., A.W. Wolf, and M.J.

Kennard, et al. 1986. ‘‘Intrauterine

Exposure to Low Levels of Lead: The

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42. McMichael, A.J., P.A. Baghurst,

and N.R. Wigg, et al. 1988. ‘‘Port Pirie

Cohort Study: Environmental Exposure

to Lead and Children’s Abilities at the

Age of Four Years.’’ New England

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43. Fulton, M., G. Raab, G. Thomson,

D. Laxen, R. Hunter, and W. Hepburn.

1987. ‘‘Influence of Blood Lead on the

Ability and Attainment of Children in

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44. Landsdown, R., W. Yule, and M.A.

Urbanowicz, et al. 1986. ‘‘The

Relationship Between Blood Lead

Concentrations, Intelligence, Attainment

and Behavior in a School Population:

The Second London Study.’’

International Archives of Occupational

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45. Yule, W., R. Landsdown, I. Millar,

and M. Urbanowicz. 1981. ‘‘The

Relationship Between Blood Lead

Concentration, Intelligence, and

Attainment in School Population: A

Pilot Study.’’ Developments in Medical

Child Neurology. 23:567-576.

46. Schroeder, S.R., B. Hawk, D. Otto,

P. Mushak, and R.E. Hicks. 1985.

‘‘Separating the Effect of Lead and

Social Factors in IQ.’’ Environmental

Research. 91:178-183.

47. Hawk, B.A., S.R. Schroeder, and

G. Robinson, et al. 1986. ‘‘Relation of

Lead and Social Factors to IQ of LowSES Children: A Partial Replication.’’

American Journal of Mental Deficiency.

91:178-183.

48. Schwartz, J. 1994. ‘‘Low-Level

Lead Exposure and Children’s IQ: A

Meta-Analysis and Search for a

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65:42-55.

49. Schwartz, J., C. Angle, and H.

Pitcher. 1986. ‘‘The Relationship

Between Childhood Blood Lead and

Stature.’’ Pediatrics. 77:281-288.

50. Bornschein, R. L.; Grote, J.;

Mitchell, T., Succop. P. A.; Dietrich, K.

N.; Kraft, K. M.; Hammond, P. B. 1989.

‘‘Effects of Prenatal Lead Exposure on

Infant Size at Birth.’’ In: Smith, M. A.;

Grant, L.D.; Sors, A. I., eds. Lead

Exposure and Child Development: An

International Assessment. Lancaster,

United Kingdom: Kulwer Academic

Publishers.

51. Shukla, R., K.N. Dietrich, R.L.

Bornschein, O. Berger, and P.B.

Hammond. 1991. ‘‘Lead Exposure and

Growth in the Early Preschool Child: A

Follow-Up Report from the Cincinnati

Lead Study.’’ Pediatrics. 88(5):886-92.

52. Bhattacharya, A., R. Shukla., R.

Bornschein, K. Dietrich, and J.E. Kopke.

1988. ‘‘Postural Disequilibrium

Quantification in Children with Chronic

Lead Exposure: A Pilot Study.’’

Neurotoxicology. 9(3):327-40.

53. McMichael, A.J., G.V. Vimpani,

and E.F. Robertson, et al. 1986. ‘‘The

Port Pirie Cohort Study: Maternal Blood

Lead and Pregnancy Outcome.’’

Pediatrics. 89(4):740-742.

54. Moore, M.R., A. Goldberg, and S.

Pocock, et al. 1982. ‘‘Some Studies of

Maternal and Infant Lead Exposure in

Glasgow.’’ Scotland Medical Journal.

27:113-122.

55. Pocock, S.J., A.G. Shaper, D.

Ashby, T. Delves, and T.P. Whitehead.

1984. ‘‘Blood Lead Concentration, Blood

Pressure, and Renal Function.’’ British

Medical Journal. 289(6449):872-4.

56. U.S. Environmental Protection

Agency. 1986. Air Quality Criteria

Document for Lead. Research Triangle

Park, NC. Office of Research and

Development. EPA 600/8-83-028F.

57. U.S. Environmental Protection

Agency. January 1990. Report of the

Clean Air Scientific Advisory Committee

on its Review of the OAQPS Lead Staff

Paper and the ECAO Air Quality

Criteria Document Supplement. EPASAB-CASAC-90-002.

58. U.S. Environmental Protection

Agency. 1990. Air Quality Criteria for

Lead: Supplement to 1986 Addendum.

Office of Research and Development.

EPA/600-8-89/049F.

59. U.S. EPA, Office of Air Quality

Planning and Standards. December

1990. Review of the National Ambient

Air Quality Standards for Lead:

Assessment of Scientific and Technical

Information. (OAQPS Staff Paper.) EPA450/2-89-022.

60. Davis, J.M. and D.J. Svendsgaard.

1987. ‘‘Lead and Child Development.’’

Nature. 329:297-300.

61. Mushak, P., J.M. Davis, A.F.

Crocetti, and L.D. Grant. October 1989.

‘‘Prenatal and Postnatal Effects of LowLevel Lead Exposure: Integrated

Summary of a Report to the U.S.

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62. U.S. Department of Health and

Human Services, Agency for Toxic

Substances and Disease Registry. 1988.

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in Children in the United States: A

Report to Congress.

63. National Academy of Sciences.

1993. Measuring Lead Exposure in

Infants, Children, and Other Sensitive

Populations.

64. Battelle Memorial Institute.

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September 3, 1997.

65. University of Cincinnati. July

1990. Midvale Community Lead Study:

Final Report.

66. Lewis and Clark County Health

Department, Montana Department of

Health and Environmental Sciences,

U.S. Department of Health and Human

Services, and U.S. Environmental

Protection Agency. July 1986. East

Helena, Montana: Child Lead Study,

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67. Hogan K, Elias R, Marcus A, White

P. 1995. ‘‘Assessment of the USEPA

IEUBK Model Prediction of Elevated

Blood Lead Levels.’’ The Toxicologist

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68. Bureau of the Census, Department

of Housing and Urban Development.

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69. Salkever, David. 1995. ‘‘Updated

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70. U.S. Department of Commerce.

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71. U.S. Department of Education.

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72. Wallston, T.S. and R.G. Whitfield.

1986. Assessing the Risks to Young

Children of Three Effects Associated

with Elevated Blood-Lead Levels. Report

by Argonne National Laboratory. Report

No. ANL/AA-32. Sponsored by the U.S.

Environmental Protection Agency,

Office of Air Quality Planning and

Standards.

73. American Academy of Pediatrics.

1996. ‘‘Treatment Guidelines for Lead

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96(1):55-160.

74. Kakalik, J. et al. 1981. The Cost of

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75. Hometech. 1996. Remodeling and

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76. Means, R.S. 1996. Repair and

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to the National Center for Lead-Safe

Housing and president of Urban

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personal communication with Chris

Paciorek, Abt Associates Inc., July 1996.

78. U.S. Department of Commerce,

Economics and Statistics

Administration and Bureau of the

Census and U.S. Department of Housing

and Urban Development, Office of

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United States in 1995.

79. U.S. Department of Housing and

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Prevention. 1996. Regulatory Impact

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Notification, Evaluation and Reduction

of Lead-Based Paint Hazards in

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and Housing Receiving Federal

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80. Lead-Based Paint Hazard

Reduction and Financing Task Force.

July 1995. Putting the Pieces Together:

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Housing.

81. National Center for Lead-Safe

Housing. SpecMaster Database,

provided to Chris Paciorek, Abt

Associates by Jonathan Wilson, NCLSH,

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82. National Center for Lead-Safe

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Nonprofit Housing Organizations.

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83. U.S. Environmental Protection

Agency. 1998. Economic Analysis of

TSCA Section 403: Hazard Standards.

84. U.S. Environmental Protection

Agency. July 14, 1994. Soil Screening

Guidance.

85. Battelle Memorial Institute.

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86. Stedman’s Medical Dictionary.

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87. Rabinowitz, M.B. and G.W.

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88. Manton, W.I. July-August 1977.

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89. Yaffe, Y., C.P. Flessel, J.J.

Wesolowski, A. del Rosario, G.N.

Guirguis, V. Matias, J.W. Gramlich, W.R.

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1983. ‘‘Identification of lead sources in

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90. Rabinowitz, M.B. 1987. ‘‘Stable

Isotope Mass Spectrometry in

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91. Clark, C.S., R.L. Bornschein, P.

Succop, S.S. Que Hee, P.B. Hammond,

and B. Peace. 1985. ‘‘Condition and

Type of Housing as an Indicator of

Potential Environmental Lead Exposure

and Pediatric Blood Lead Levels.’’

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92. Green, T. and C.B. Ernhart. 1991.

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Exposure: Relationship with Size.’’

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93. Battelle Memorial Institute.

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4, 1996.

94. National Center for Lead-Safe

Housing. Memorandum to Dave Jacobs

and Steve Weitz, U.S. Department of

Housing and Urban Development. July

1, 1997.

95. McElvaine, M.D., et al. 1992.

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of Paint Chip Ingestion Among Children

with Moderate to Severe Lead

Poisoning, St. Louise, Missouri, 1989

through 1990.’’ Pediatrics. 89(4):740-

742.

96. National Center for Lead-Safe

Housing. May 1997. Data tables based

on November 1996 data for HUD

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Programs provided to Jonathan

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Agency.

97. National Conference of State

Legislatures. August 1997. Lead

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Contracts, 1997-1998.

98. U.S. Environmental Protection

Agency. January 31, 1996. Statistical

Evaluation of the Relationship Between

Blood Lead and Dust Lead Based on

Pre-Intervention Data from R&M Study.

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99. U.S. Environmental Protection

Agency. February 22, 1996. Statistical

Evaluation of the Relationship Between

Blood Lead and Dust Lead Based on

Pre-Intervention Data from the

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D2-0139.

100. Bornschein, R.L., P.A. Sucoop,

K.M. Kraft, C.S. Clark, B. Peace, and P.B.

Hammond. 1987. ‘‘Exterior Surface Dust

Lead, Interior House Dust Lead and

Childhood Lead Exposure in an Urban

Environment.’’ In Trace Substances in

Environmental Health. XX. Proceedings

of University of Missouri’s 20th Annual

Conference, June 1996 (D.D. Hemphill,

Ed.), pp. 322-332, University of

Missouri, Columbia, MO.

101. Lanphear, B.P., M. Emond, D.E.

Jacobs, M. Wesetzonan, M. Tanner, N.L.

Winter, B. Yakis, and S. Eberly. 1995.

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Collection Methods for Sampling LeadContaminated House Dust.’’

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102. U.S. Environmental Protection

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Residential Lead Exposure in Children.

Peer Review Draft. April 27.

103. Dickey, E.C., P.J. Jasa, and D.P.

Shelton. 1986. Estimating Residue

Cover. NebGuide G86-793. University of

Nebraska, Institute of Agriculture and

Natural Resources.

104. Connor, Patrick, Connor

Environmental Services, personal

communication with Jonathan Jacobson,

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August 15, 1996.

105. U.S. Environmental Protection

Agency. December 3, 1997. Analysis of

Lead Dust Clearance Testing. Peer

Review Draft.

106. Mielke, H.W. 1994. ‘‘Lead in

New Orleans Soils: New Images of an

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Geochemistry and Health. 16(3-4):123-

128.

107. U.S. Environmental Protection

Agency. February 1985. Costs and

Benefits of Reducing Lead in Gasoline:

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Prepared by U.S. Environmental

Protection Agency, Office of Policy

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108. U.S. Environmental Protection

Agency. December 1986. Reducing Lead

in Drinking Water: A Benefit Analysis.

Prepared by U.S. Environmental

Protection Agency, Office of Policy
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30349

Planning and Evaluation, Draft Final

Report.

XII. Regulatory Assessment

Requirements

A. Executive Order 12866

The Agency submitted this proposed

action to the Office of Management and

Budget (OMB) for review under

Executive Order 12866, entitled

Regulatory Planning and Review (58 FR

51735, October 4, 1993), and any

changes made during that review have

been documented in the public record.

OMB has determined that this proposed

action is ‘‘economically significant,’’

because this proposed rule may result in

behavioral changes that involve

increased expenditures by owners of

target housing and child-occupied

facilities, with a potential annual effect

on the economy of $100 million or

more. Although the establishment of the

standards contained in this proposed

rule do not, in and of themselves,

mandate any action, the Agency

recognizes that the existence of the

hazard standards may influence the

decisions or actions of owners of target

housing.

The Agency believes that, in

establishing the standards, it is

appropriate to consider the potential

costs and benefits associated with the

possible actions that an owner could or

might take based on the hazard

standard. The Agency has therefore

prepared an economic analysis which

assumes that a risk assessment would be

conducted in all target housing at the

time a newborn enters the home, that

the owners of the target housing would

respond to all identified hazards, and

that no activities would occur in the

absence of the 403 standards.

The Agency recognizes, however, that

risk assessments will not be conducted

in all target housing, nor will all the

owners of target housing respond to all

identified hazards. In addition,

intervention activities are occurring and

will continue to occur, even in the

absence of the 403 standards.

Consequently, EPA believes that this

analysis overestimates the potential

costs and benefits associated with the

non-mandatory intervention activities

related to the establishment of the

proposed standards. Furthermore, EPA

used other assumptions in the analysis

(e.g., the use of a birth trigger for testing

and hazard intervention activities, and

the use of a 3 percent discount rate),

that can potentially affect the relative

balance of costs and benefits. These

assumptions are summarized below in

the discussion of the Agency’s

sensitivity analyses, which are

presented in Chapter 7 of the Agency’s

economic analysis.

This analysis is contained in a

document entitled Economic Analysis of

Proposed Lead Hazard Standards (Ref.

83), and is available as a part of the

public record for this action. The

analysis was used by the decisionmakers to help in the selection of the

hazard standards proposed in this

document. The following summary of

the economic analysis presents the

benefits, costs, and net benefits for those

activities that could be potentially

related to the establishment of the lead

hazard standards (i.e., related to leadbased paint hazard interventions, as

well as the costs of conducting risk

assessments to evaluate homes for leadbased paint hazards). The Agency

presents costs and benefits for paint

interventions separately because they

did not affect the Agency’s evaluations

and decisions regarding dust and soil.

As discussed in Unit IV. of this

preamble, EPA did not use the

economic analysis of the paint

component of the proposed regulation

in selecting the preferred option for the

paint standard due to data limitations.

EPA presents the costs of conducting

risk assessments separately because

these costs are the same for all dust and

soil standard options and, therefore, did

not affect the Agency’s decision-making

on the standards.

In general, the economic analysis is

designed to provide comparisons of

different standards, and does not

attempt to predict precisely how much

remediation of residential lead-based

paint hazards will occur as a result of

promulgating these standards. The

economic analysis compares alternative

standard options in terms of their net

benefits. Net benefits are based on the

benefits of risk reduction minus the

costs of control activities needed to

achieve the reduction in risk. The

benefit categories all measure health

effects resulting from childhood lead

exposure. The analysis calculates net

benefits for a wide range of alternative

standards, including the proposed

section 403 hazard levels.

The total costs (estimated over a 50-

year span, and discounted at 3 percent)

for setting the proposed dust and soil

standards, which are based on the

proposed standard of 50 μg/ft2 for floor

dust, 250 μg/ft2 for window sill dust and

2,000 ppm for soil, are estimated to be

$19 billion, while the total estimated

benefits are $108 billion using the

IEUBK model and $39 billion using the

empirical model, resulting in estimated

net benefits of $89 billion using the

IEUBK model and $19 billion using the

empirical model. For paint

interventions, the estimated total cost is

$20 billion, with total estimated benefits

of $59 billion using the IEUBK model

and $5 billion using the empirical

model, resulting in estimated net

benefits of $39 billion using the IEUBK

model and -$15 billion using the

empirical model. The total estimated

costs for testing are $14 billion, and the

Agency did not estimate any benefits for

potential testing activities. About 25.4

million homes are projected to exceed

one or more of the standards, and the

Agency projected approximately 43.8

million children would experience

reduced exposure to household lead in

soil, dust, and paint.

1. Dust and soil analysis. The

monetized benefits estimated over the

50-year modeling period for the

proposed TSCA section 403 standards of

50 μg/ft2 floor dust, 250 μg/ft2 window

sill dust, and 2,000 ppm soil are $39

billion from the empirical model and

$108 billion from the IEUBK model.

These estimates are based on the

following assumptions: that all owners

of target housing will conduct a risk

assessment to identify lead hazards at

the time when a newborn child enters

the home; that these owners will

respond to all identified lead hazards;

and that no intervention activities will

occur in the absence of the 403

standards.

As would be expected, alternative

dust and soil standards that are more

stringent than these are estimated to

produce additional benefits. Changes in

stringency affect the benefits differently

depending upon the model used. For

the empirical model, benefits fall within

a fairly tight range of $30 to $47 billion,

when options range from 1,000 to 5,000

ppm for soil, from 50 to 200 μg/ft2 for

floor dust, and 100 to 500 μg/ft2 for

window sill dust. For the IEUBK model,

the range of benefits over these

alternative options is wider, from

approximately $73 billion to $150

billion.

The costs for the proposed TSCA

section 403 standards of 50 μg/ft2 floor

dust, 250 μg/ft2 window sill dust, and

2,000 ppm soil (estimated over the 50-

year modeling period and discounted at

3 percent) are $19 billion. This

represents the costs of interventions to

reduce soil and dust-lead levels in

response to these standards. EPA

estimates costs independently of the

two models (i.e., IEUBK, empirical).

Costs, therefore, are the same for both

analytical approaches. Alternative dust

and soil options that are more stringent

than the proposed standards are

estimated to have higher costs. Changes

in stringency ranging from 1,000 to

5,000 ppm for soil, 40 to 200 μg/ft2 for
30350 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

floor dust, and 100 to 500 μg/ft2 for

window sill dust, produce a range of

costs from about $12 billion to about

$38 billion.

The net benefits of the proposed

TSCA section 403 standards for dust

and soil are shown in Table 12 below.

Net benefits have been used to evaluate

alternative lead hazard levels. The

estimated net benefits for the proposed

standards of 50 μg/ft2 for floor dust, 250

μg/ft2 for window sill dust, and 2,000

ppm for soil are $19 billion (using the

empirical model for blood lead) or $89

billion (using the IEUBK model).

Table 12 also provides an indication

of the net benefits corresponding to a

range of options for the proposed lead

hazard standards. Using the empirical

model, the net benefits appear to be near

the maximum at 2,000 ppm and 5,000

ppm. At the same time, net benefits

decrease (in fact become negative) with

more stringent soil options under the

empirical model.

Table 12.—Net Benefits from Hazard Options Varying around the Proposed Standard: Point Estimates and Ranges*

Hazard Standard Net Benefits ($Billions)

Floor Dust (μg/ft2) Window Sill Dust

(μg/ft2) Soil (ppm) IEUBK Model Empirical Model

Range of Soil Options 50 250 500 143 5

50 250 2,000 89 19

50 250 5,000 61 21

Range of Floor Dust Options 50 250 2,000 89 19

100 250 2,000 77 19

Range of Sill Dust Options 50 100 2,000 N/A 16

50 250 2,000 N/A 19

50 500 2,000 N/A 19

*Net Benefits do not include the costs and benefits of paint interventions, nor testing costs. The models paint intervention costs (over 50 years

discounted at 3 percent) are $20 billion. Paint intervention benefits (over 50 years discounted at 3 percent) are $59 billion with the IEUBK Model

and $5 billion with the empirical model. Testing costs (over 50 years discounted at 3 percent) are approximately $14 billion. As explained in Unit

IV. of this preamble, the net benefit estimates generated by the IEUBK model-based approach and the empirical model-based approach are not

comparable.

The IEUBK model, on the other hand,

suggests that maximum net benefits

occur at more stringent options, and

decline with less stringent ones. Net

benefits do not vary substantially under

either model across the range of dust

options evaluated.

Given overall modeling uncertainties,

and the fact that both models suggest

that net benefits are positive in the

2,000 ppm soil range, the proposed soil

and dust standards appear to provide a

reasonable combination of national

values that will tend to maximize the

net benefits of performing interventions

to protect children from exposure to

lead from these sources. In addition to

the relative net benefits, each hazard

standard was evaluated in terms of

number of children protected. Under the

proposed option, it is estimated that the

number of children with blood-lead

concentrations equal to or exceeding 10

μg/dl would decline by 2 to 6 million

over 50 years and the number of

children with blood-lead concentrations

equal to or exceeding 20 μg/dl would

decline by 300,000 to 700,000 in the

same timeframe (estimated by the

empirical-model based analysis and the

IEUBK-model based analysis

respectively) (Ref. 83).

2. Paint analysis. EPA used the

available data on deterioration from the

HUD National Survey to estimate costs

and benefits associated with repairing or

abating deteriorated paint. The Survey

reports only the total deterioration in

each residence, whereas the proposed

hazard standard for paint is based on

the amount of deterioration per

component in a residence. Because of

this difference, as noted in Unit IV. of

this preamble, the Agency was unable to

use this analysis in selecting a preferred

option. In summary, the empirical

model-based analysis estimates benefits

of $5 billion and the IEUBK modelbased analysis estimates benefits of $59

billion. The costs for paint interventions

are estimated to be $20 billion yielding

net benefits for paint of $-15 billion

using the empirical model-based

analysis and $39 billion using the

IEUBK model-based analysis. For the

following reasons, however, the

reliability and usefulness of these

estimates for characterizing the

economic impacts of the proposed

standard for deteriorated lead-based

paint is significantly limited due to

differences in approach and data used.

It is also inappropriate to compare the

results of each analytical approach.

First, as previously noted, the

determination of where paint

interventions occur is based on the HUD

National Survey, which reports

deterioration for an entire residence.

The proposed standard, however, is

based on the amount of deterioration

per component. There is no way to

relate the two measurements.

Second, the lack of data to relate

quantitatively deteriorated paint to

blood-lead concentration limits EPA’s

ability to measure benefits associated

with direct ingestion of lead-based

paint. Both modeling approaches (i.e.,

IEUBK-based and empirical-based)

predict benefits based only on the

presence or absence of deteriorated

paint. Thus, each model’s estimate of

benefits remains unchanged regardless

of the amount of deterioration present.

Third, under the empirical modelbased analysis, only interior paint

abatement, which is accompanied by

dust cleaning, yields dust-related

benefits. The analysis does not predict

any dust-related benefit for interior

paint repair or exterior paint repair or

abatement. As discussed in Chapter 4 of

the Agency’s risk analysis, EPA used

data from several abatement studies to

estimate the impact of dust cleaning on

dust-lead loading when sources of dustlead contamination were abated. In

contrast, the Agency has no basis for

estimating the impact of source control

alone on dust-lead loading. It is likely,

however, that other paint interventions

would reduce dust-lead loading. Thus,

the empirical model-based analysis

probably underestimates the dustrelated benefits of paint intervention.
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30351

3. Testing costs. EPA estimates that

the costs of conducting risk assessment

to test target housing for the presence of

lead-based paint hazards is $14 billion.

The analysis assumes that each target

housing unit will be tested at the time

a newborn enters the home. Testing

costs are the same for all hazard

standard options. Likewise, the testing

costs cannot be assigned to one medium

or another because testing costs assume

that each of the three media (paint, dust,

and soil) are addressed.

4. Sensitivity and uncertainty

analyses. The economic analysis

addresses the robustness of results by

reporting model outcomes when each of

several different parameters or

assumptions are changed. The

parameters considered are the discount

rate and the value of an IQ point. In

addition, the assumption that avoiding

small losses of IQ (i.e., less than one

point) provides an economic benefit was

examined. The first parameter analyzed

is discount rate. In the base model, a

rate of 3 percent is used. In the

sensitivity analysis, 7 percent is used

because this is the value recommended

in the January 11, 1996 OMB Guidance

entitled Economic Analysis of Federal

Regulations Under Executive Order No.

12866. When the discount rate is 7

percent, model results at each possible

standard option change from the base

model in the following way: costs

decrease, benefits decrease substantially

more, and net benefits decrease.

Following from these changes, the

options at which net benefit would be

maximized are less stringent in a 7

percent discount regime than in a 3

percent discount regime. Benefits

decrease more than costs because they

would be realized over a much longer

time horizon, the economically

productive lifetime of affected

individuals. Costs for actions to protect

a given individual would be incurred

before the sixth birthday.

The second parameter tested is the

value of an IQ point. The base model

uses an IQ point value of $8,346, based

on recently published analyses (Ref. 69).

As an alternative, benefits were

calculated using an IQ point value of

$6,847, from earlier EPA analyses (Refs.

109 and 110). The total cost calculated

would be the same under each

assumption, because this parameter

does not affect costs. The benefits and

net benefits, however, for all options

would be lower when the alternative,

smaller IQ value is used, because over

95 percent of total benefits are due to

changes in IQ. The effect on benefits is

small enough, however, that there is no

effect on which the standard would

maximize net benefits in the IEUBK

model, and the empirical model-based

analysis predicts only a small decrease

of stringency of the window sill dust

standard. Thus, the choice of standard

is not sensitive to the use of this revised

value of an IQ point.

The third issue EPA examined in the

sensitivity analysis was the effect of the

value of small IQ point differences. The

Agency’s analysis assumes that a

difference in average blood-lead levels

between two populations, no matter

how small that difference is and

regardless of the magnitude of bloodlead levels involved, is associated with

a corresponding difference in average IQ

scores. In the cost-benefit analysis

performed for these standards, the

Agency is essentially comparing the

blood-lead distributions that would

occur between two populations: one

with the TSCA section 403 standards

versus one without the 403 standards.

Furthermore, the analysis relies on the

empirical finding that a difference in

average IQ scores between two

populations, again no matter how small,

is associated with a difference in

average lifetime earnings. Note that it is

not possible to say that for any pair of

individuals that a difference in bloodlead will necessarily reflect a difference

in IQ scores or lifetime earnings. The

available research, however, does

demonstrate that such differences do

occur on the average for groups of

individuals.

Notwithstanding the fact that the risk

assessment and benefit-cost analysis

were constrained to address population

average changes, it was recognized that

there might be an interest in considering

the contribution to those population

average changes made by subgroups in

the population whose particular bloodlead and IQ point improvements might

be considered small. An analysis was

therefore performed and presented in

section 7.3.1 of the Economic Analysis

to try to characterize the portion of the

total benefits from IQ improvements

that were contributed by that portion of

the population having improvements of

less than 1 IQ point. The computational

considerations involved in doing that

analysis were discussed in detail there.

That special analysis showed that, at the

proposed standards (window sill dust at

250 μg/ft2; floor dust at 50 μg/ft2; soil at

2,000 ppm), the contribution of these

small IQ point improvements in the

population, contributed 30 percent of

the value of the IQ point benefits under

the IEUBK model and 90 percent of the

IQ point benefits under the empirical

model.

The Agency, however, recognizes that

the methodology used for this

sensitivity analysis is preliminary in

nature and should not be relied upon for

decision-making purposes. More

importantly, the Agency is not aware of

any technical basis or rationale for not

including the benefits associated with

small IQ changes.

B. Regulatory Flexibility Act (RFA)

Pursuant to section 605(b) of the

Regulatory Flexibility Act (5 U.S.C. 601

et seq.), the Agency hereby certifies that

this proposed action will not have a

significant economic impact on a

substantial number of small entities. As

previously discussed, this proposed rule

does not, in and of itself, mandate any

action, or directly impose any costs. The

Agency does, however, recognize that

the existence of the hazard standards

may influence the decisions or actions

of owners of target housing, and has

therefore considered the potential costs

and benefits associated with the

possible actions that an owner could or

might take based on the hazard

standard. The Agency also involved

potentially affected entities, including

representatives of small businesses (e.g.,

owners of multi-housing and rental

properties), and State/Tribal and local

governmental agencies, in an extensive

‘‘dialogue’’ process, which is discussed

in more detail in Unit II. of this

preamble, as well as other mechanisms

of communication.

In addition, although other

regulations implementing other sections

of Title X will use or reference the

hazard standards that are proposed in

this document, the impacts of those

regulations on small entities are

evaluated in the context of those

regulations. To date, EPA has

promulgated regulations under sections

402, 404, 406, and 1018. For each of

these regulations, EPA evaluated the

potential impacts on small entities in

compliance with the RFA.

Information relating to this

determination will be provided to the

Chief Counsel for Advocacy of the Small

Business Administration upon request,

and is included in the docket for this

proposal. Any comments regarding the

economic impacts that this proposed

regulatory action may impose on small

entities should be submitted to the

Agency at the address listed above.

C. Unfunded Mandates Reform Act

(UMRA) and Executive Order 12875

Although the requirements of Title II

of the Unfunded Mandates Reform Act

of 1995 (UMRA) (Pub. L. 104-4) and

Executive Order 12875, Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), do not apply

to this proposed rule, the Agency

believes that its consideration of the
30352 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

potential costs and benefits of those

non-mandatory activities that could be

potentially related to the establishment

of the lead hazard standards, i.e.,

activities related to lead-based paint

hazard interventions and risk

assessments, as well as its discussions

with State and Tribal governments,

address these requirements. The UMRA

requirements in sections 202 and 205 do

not apply to this proposed rule, because

this action does not contain any

‘‘Federal mandates’’ or impose any

‘‘enforceable duty’’ on State/Tribal, or

local governments or on the private

sector. The requirements in section 203

do not apply because this proposed rule

does not contain any regulatory

requirements that might significantly or

uniquely affect small governments. In

addition, since this is not a

discretionary act containing an

unfunded mandate, no consultation is

required under the Executive Order.

Nevertheless, the Agency recognizes

that the existence of the hazard

standards may influence the decisions

or actions regarding the intervention

activities undertaken by State/Tribal or

local governments as potential owners

of child-occupied facilities, even if

those actions are not mandated by this

or any other EPA regulation. The

Agency therefore believes that it is

important to consider the potential

impacts of this proposed rule on State/

Tribal or local governments. It is, of

course, difficult to predict whether or

what intervention activities might be

undertaken by State/Tribal or local

governments as a result of the

establishment or existence of the

proposed hazard standards, but the

Agency does not believe that the

analysis needs to differentiate between

ownership in considering the potential

costs related to the possible intervention

activities. Therefore, since the Agency

considered the potential costs and

benefits associated with possible

intervention activities in selecting the

proposed hazard standards, the Agency

has also considered the potential costs

that might be experienced by State/

Tribal or local governments.

Intervention activities in child-occupied

facilities, because a much larger number

of children are involved, will naturally

result in greater benefits, increasing the

ratio between costs and benefits

significantly.

D. Paperwork Reduction Act (PRA)

This proposed regulatory action does

not contain any information collection

requirements that require additional

approval by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq. Specifically, States and Tribes with

authorized programs under 40 CFR part

745, subpart L will still need to

demonstrate their standards for

identifying lead-based paint hazards

and soil-lead level of concern, and

clearance standards for dust, in the

reports that they submit to EPA under

40 CFR 745.324(h). This reporting

requirement is contained in the

regulations implementing TSCA

sections 402(a) and 404, for which the

Information Collection Request (ICR)

has already been approved by OMB

under control number 2070–0155 (EPA

ICR No. 1715). As a part of the economic

analysis, EPA also re-examined this ICR

and determined that the burden

estimates provided in the ICR would not

change as a result of the promulgation

of the standards proposed. Because

there are no new information collection

requirements to consider, or any

changes to the existing requirements

that might impact the existing burden

estimates, additional OMB review and

approval under the PRA is not

necessary.

Under the PRA, ‘‘burden’’ means the

total time, effort, or financial resources

expended by persons to generate,

maintain, retain, or disclose or provide

information to or for a Federal agency.

This includes the time needed to review

instructions; develop, acquire, install,

and utilize technology and systems for

the purposes of collecting, validating,

and verifying information, processing

and maintaining information, and

disclosing and providing information;

adjust the existing ways to comply with

any previously applicable instructions

and requirements; train personnel to be

able to respond to a collection of

information; search data sources;

complete and review the collection of

information; and transmit or otherwise

disclose the information.

An Agency may not conduct or

sponsor, and a person is not required to

respond to a collection of information

subject to OMB approval under the PRA

unless it displays a currently valid OMB

control number. The OMB control

numbers for EPA’s regulations, after

initial publication in the Federal

Register, are maintained in a list at 40

CFR part 9.

Comments are requested on the

Agency’s need for this information, the

accuracy of the provided burden

estimates, and any suggested methods

for minimizing respondent burden,

including through the use of automated

collection techniques. Send comments

on the ICR to EPA at the address

provided in the ‘‘ADDRESSES’’ section,

with a copy to the Office of Information

and Regulatory Affairs, Office of

Management and Budget, 725 17th St.,

NW., Washington, DC 20503, marked

‘‘Attention: Desk Officer for EPA.’’

Please remember to include the ICR

number in any correspondence. The

final rule will respond to any comments

on the information collection

requirements contained in this proposal.

E. Executive Order 12898

Pursuant to Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), the Agency has considered

environmental justice-related issues

with regard to the potential impacts of

this proposed action on the

environmental and health conditions in

low-income and minority communities.

The Agency’s analysis found that nonwhite households are more likely to live

in housing with lead-based paint

hazards, and their children are expected

to realize greater reductions in bloodlead levels if these hazards are

mitigated. As a result, non-white

households are expected to bear more of

the costs of responding to the section

403 standards but also receive more of

the benefits. Lower- and upper-income

households face roughly the same

response costs and are expected to

receive the same blood-lead reductions.

Lower-income households would have

to forego a larger share of their income

to respond to the section 403 standards

(Ref. 83).

F. Executive Order 13045

This proposed rule is subject to

Executive Order 13045, entitled

Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997),

because OMB has determined that this

is an economically significant regulatory

action as defined by Executive Order

12866 (see section A. of this unit), and

the Agency has reason to believe that

the environmental health or safety risk

addressed by this action may have a

disproportionate affect on children. In

accordance with section 5(501) of

Executive Order 13045, the Agency has

evaluated the environmental health or

safety effects of lead-based paint on

children in the selection of the hazard

standards contained in this proposed

rule. The results of this evaluation are

contained in the ‘‘Risk Analysis to

Support Standards for Lead in Paint,

Dust and Soil’’ (Ref. 1), which is

summarized and discussed in Unit IV.

of this preamble; a copy has been placed

in the docket for this action.

Futhermore, the proposed regulation

would help to prevent lead poisoning
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30353

among young children by supporting

the implementation of the national lead

program. Because exposure to lead in

paint, dust, and soil is mostly limited to

children under the age of 6, young

children are, in fact, the primary

beneficiaries of this proposed rule, as

well as the program.

G. National Technology Transfer and

Advancement Act

This proposed regulatory action does

not involve any technical standards that

would require Agency consideration of

voluntary consensus standards pursuant

to section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (NTTAA), Pub. L. 104-113,

section 12(d) (15 U.S.C. 272 note).

Section 12(d) directs EPA to use

voluntary consensus standards in its

regulatory activities unless to do so

would be inconsistent with applicable

law or otherwise impractical. Voluntary

consensus standards are technical

standards (e.g., materials specifications,

test methods, sampling procedures,

business practices, etc.) that are

developed or adopted by voluntary

consensus standards bodies. The

NTTAA requires EPA to provide

Congress, through OMB, explanations

when the Agency decides not to use

available and applicable voluntary

consensus standards. EPA invites public

comment on this conclusion.

List of Subjects in Part 745

Environmental protection, Hazardous

substances, Lead-based paint, Lead

poisoning, Reporting and recordkeeping

requirements.

Dated: May 26, 1998.

Carol M. Browner,

Administrator.

Therefore, it is proposed that 40 CFR

part 745 be amended as follows:

PART 745—[AMENDED]

1. The authority citation for part 745

continues to read as follows:

Authority: 15 U.S.C. 2605, 2607, 2615,

2681-2692 and U.S.C. 4852d.

2. By adding new subpart D to read

as follows:

Subpart D—Lead-Based Paint Hazards

Sec.

745.61 Scope and applicability.

745.63 Definitions.

745.65 Lead-based paint hazards.

745.69 Determining whether lead-based

paint hazards are present.

Subpart D—Lead-Based Paint Hazards

§ 745.61 Scope and applicability.

(a) This subpart identifies lead-based

paint hazards.

(b) The standards for lead-based paint

hazards apply to target housing and

child-occupied facilities.

(c) Nothing in this subpart requires

any person to evaluate the property(ies)

for the presence of lead-based paint

hazards or to take any action to control

these conditions if one or more of them

is identified.

§ 745.63 Definitions.

The following definitions apply to

this subpart.

Arithmetic mean means the algebraic

sum of data values divided by the

number of data values (e.g., the sum of

the concentration of lead in several soil

samples divided by the number of

samples).

Certified risk assessor means an

individual who has been trained by an

accredited training program, as defined

by § 745.223, and certified by EPA

pursuant to § 745.226 or by an

authorized State or Tribal program to

conduct risk assessments. A certified

risk assessor also samples for the

presence of lead in dust and soil for the

purposes of abatement clearance testing.

Child-occupied facility means a

building, or portion of a building,

constructed prior to 1978, visited

regularly by the same child, 6 years of

age or under, on at least two different

days within any week (Sunday through

Saturday period), provided that each

day’s visit lasts at least 3 hours and the

combined weekly visit lasts at least 6

hours, and the combined annual visits

last at least 60 hours. Child-occupied

facilities may include, but are not

limited to, day-care centers, preschools,

and kindergarten classrooms.

Deteriorated paint means paint that is

cracking, flaking, chipping, peeling, or

otherwise separating from the substrate

of a building component.

Interior window sill means the portion

of the horizontal window ledge that

protrudes into the interior of the room.

Lead-based paint means paint or

other surface coatings that contain lead

equal to or exceeding 1.0 milligram per

square centimeter or 0.5 percent by

weight.

Lead-based paint hazard means

hazardous lead-based paint, a dust-lead

hazard, or a soil-lead hazard as

described in § 745.65.

Paint in poor condition means more

than 10 square feet of deteriorated paint

on exterior components with large

surface areas; or more than 2 square feet

of deteriorated paint on interior

components with large surface areas

(e.g., walls, ceilings, floors, doors); or

more than 10 percent of the total surface

area of the component is deteriorated on

interior or exterior components with

small surface areas (e.g., window sills,

baseboards, soffits, trim).

Risk assessment means an on-site

investigation to determine the existence,

nature, severity, and location of leadbased paint hazards, and the provision

of a report by the individual or the firm

conducting the risk assessment,

explaining the results of the

investigation and options for reducing

lead-based paint hazards.

Target housing means any housing

constructed prior to 1978, except

housing for the elderly or persons with

disabilities (unless any one or more

children age 6 years or under resides or

is expected to reside in such housing for

the elderly or persons with disabilities)

or any 0-bedroom dwelling.

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

number of subsamples it contains. A

single surface sample is comprised of a

single subsample. A composite sample

may contain from two to four

subsamples. The weighted arithmetic

mean is obtained by summing for all

samples, the product of the sample’s

result multiplied by the number of

subsamples in the sample, and dividing

the sum by the total number of

subsamples contained in all samples.

For example, the weighted arithmetic

mean of a single surface sample

containing 60 μg/ft2, a composite sample

(3 subsamples) containing 100 μg/ft2,

and a composite sample (4 subsamples)

containing 110 μg/ft2 is 100 μg/ft2. This

result is based on the equation

[60+(3*100)+(4*110)]/8.

Wipe sample means a sample

collected by wiping a representative

surface of known area with an

acceptable wipe material (e.g., moist

towelette).

§ 745.65 Lead-based paint hazards.

(a) Hazardous lead-based paint.

Hazardous lead-based paint is leadbased paint in poor condition.

(b) Dust-lead hazard. A dust-lead

hazard is dust that contains lead equal

to or exceeding 50 μg/ft2 on uncarpeted

floors or 250 μg/ft2 on interior window

sills based on wipe samples.

(c) Soil-lead hazard. A soil-lead

hazard is bare soil that contains total

lead equal to or exceeding 2,000 parts

per million.
30354 Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules

§ 745.69 Determining whether lead-based

paint hazards or a soil-lead level of concern

are present.

(a) Applicability. This section applies

to the following:

(1) Determining whether hazardous

lead-based paint is present.

(2) Determining whether a dust-lead

hazard is present on:

(i) Uncarpeted floors.

(ii) Interior window sills.

(3) Determining whether a soil-lead

hazard is present.

(b) Work practice standards.

Determinations of the presence of leadbased paint hazards or a soil-lead level

of concern must be made by a certified

risk assessor conducting a risk

assessment according to the applicable

work practice standards at § 745.227(d)

and (h).

(c) Use of standards. (1) To determine

whether a dust-lead hazard is present, a

certified risk assessor must compare the

weighted arithmetic means of

uncarpeted floor dust samples and

interior window sill samples to the

applicable standards in § 745.65.

(2) To determine whether a soil-lead

hazard is present, a certified risk

assessor must compare the arithmetic

mean of soil samples to the applicable

standard in § 745.65.

3. In § 745.223, by alphabetically

adding the following definitions to read

as follows:

§ 745.223 Definitions.

* * * * *

Arithmetic mean means the algebraic

sum of data values divided by the

number of data values (e.g., the sum of

the concentration of lead in several soil

samples divided by the number of

samples).

* * * * *

Common area group means a group of

common areas that are similar in design,

construction, and function. Common

area groups include, but are not limited

to hallways, stairwells, and laundry

rooms.

* * * * *

Concentration means the relative

content of a specific substance

contained within a larger mass, such as

the amount of lead (in micrograms per

gram or parts per million by weight) in

a sample of dust or soil.

* * * * *

Dripline means the area within 3 feet

surrounding the perimeter of a building.

* * * * *

Interior window sill means the portion

of the horizontal window ledge that

protrudes into the interior of the room.

* * * * *

Loading means the quantity of a

specific substance present per unit of

surface area, such as the amount of lead

in micrograms contained in the dust

collected from a certain surface area

divided by the surface area in square

feet or square meters.

* * * * *

Mid-yard means an area of a

residential yard approximately midway

between the outermost edge of the

dripline of a residential building and

the nearest property boundary or

between the outermost edges of the

driplines of a residential building and

another building on the same property.

* * * * *

Residential building means a building

containing one or more residential

dwellings.

* * * * *

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

number of subsamples it contains. A

single surface sample is comprised of a

single subsample. A composite sample

may contain from two to four

subsamples. The weighted arithmetic

mean is obtained by summing for all

samples, the product of the sample’s

result multiplied by the number of

subsamples in the sample, and dividing

the sum by the total number of

subsamples contained in all samples.

For example, the weighted arithmetic

mean of a single surface sample

containing 60 μg/ft2, a composite sample

(3 subsamples) containing 100 μg/ft2,

and a composite sample (4 subsamples)

containing 110 μg/ft2 is 100 μg/ft2. This

result is based on the equation

[60+(3*100)+(4*110)]/8.

Window trough means, for a typical

double-hung window, the portion of the

exterior window sill between the

interior window well (or stool) and the

frame of the storm window. If there is

no storm window, the window trough is

the area that receives both the upper

and lower window sashes when they are

both lowered. The window trough is

sometimes referred to inaccurately as

the window ‘‘well.’’

Wipe sample means a sample

collected by wiping a representative

surface of known area with an

acceptable wipe material (e.g., moist

towelette).

4. In § 745.227, by revising paragraphs

(d)(4), (d)(5), (d)(6) introductory text,

(d)(7), (d)(8)(i), (e)(7)(i), (e)(8)(v)(A),

(e)(8)(v)(B), and (e)(8)(vii), by

redesignating paragraphs (d)(11) as

paragraph (d)(12) and paragraph (h) as

paragraph (i), and by adding paragraphs

(d)(11), (e)(8)(viii) and (h) to read as

follows:

§ 745.227 Work practice standards for

conducting lead-based paint activities:

target housing and child-occupied facilities.

* * * * *

(d) * * *

(4) Each surface with deteriorated

paint, which is determined, using

documented methodologies, to be in

poor condition and to have a distinct

painting history shall be tested for the

presence of lead. Each interior window

sill determined, using documented

methodologies, to have a distinct

painting history, shall also be tested for

the presence of lead in paint.

(5) In residential dwellings, dust

samples (either composite or singlesurface samples) from the interior

window sill(s) and floor shall be

collected in all living areas where one

or more children, age 6 and under, are

most likely to come into contact with

dust.

(6) For multi-family dwellings and

child-occupied facilities, the samples

required in paragraph (d)(4) of this

section shall be taken. In addition,

interior window sill and floor dust

samples (either composite or singlesurface samples) shall be collected in

the following locations:

* * * * *

(7) For child-occupied facilities,

interior window sill and floor dust

samples (either composite or singlesurface samples) shall be collected in

each room, hallway, or stairwell utilized

by one or more children, age 6 and

under, and in other common areas in

the child-occupied facility where the

certified risk assessor determines one or

more children, age 6 and under, are

likely to come into contact with dust.

(8) * * *

(i) Mid-yard areas where bare soil is

present; and

* * * * *

(11) The certified risk assessor shall

determine whether lead-based paint

hazards are present according to

paragraph (h) of this section.

* * * * *

(e) * * *

(7) * * *

(i) If the soil is removed: (A) The soil

shall be replaced by soil that has a level

of lead less than 400 ppm.

(B) The soil that is removed shall not

be used as top soil at another residential

property or child-occupied facility.
Federal Register / Vol. 63, No. 106 / Wednesday, June 3, 1998 / Proposed Rules 30355

* * * * *

(8) * * *

(v) * * *

(A) After conducting an abatement

with containment between abated and

unabated areas, one dust sample shall

be taken from one interior window sill

and window trough (if available) and

one dust sample shall be taken from the

floors of no less than four rooms,

hallways, or stairwells within the

containment area. In addition, one dust

sample shall be taken from the floor

outside the containment area. If there

are less than four rooms, hallways, or

stairwells within the containment area,

then all rooms, hallways, or stairwells

shall be sampled.

(B) After conducting an abatement

with no containment, two dust samples

shall be taken from no less than four

rooms, hallways, or stairwells in the

residential dwelling or child-occupied

facility. One dust sample shall be taken

from one interior window sill and

window trough (if available) and one

dust sample shall be taken from the

floor of each room, hallway, or stairwell

selected. If there are less than four

rooms, hallways, or stairwells within

the residential dwelling or childoccupied facility, then all rooms,

hallways, or stairwells shall be sampled.

* * * * *

(vii) The certified inspector or risk

assessor shall compare the residual lead

level (as determined by the laboratory

analysis) from each single surface dust

sample with applicable clearance levels

for lead in dust on floors, interior

window sills, and window troughs or

from each composite dust sample with

the applicable clearance levels for lead

in dust on floors, interior window sills,

and window troughs divided by the

number of subsamples in the composite

sample. If the residual lead level in a

single surface dust sample equals or

exceeds the applicable clearance level

or if the residual lead level in a

composite dust sample equals or

exceeds the applicable clearance level

divided by the number of subsamples in

the composite sample, all the

components represented by the failed

sample shall be recleaned and retested.

(viii) The clearance levels are 50 μg/

ft2 for uncarpeted floors, 250 μg/ft2 for

interior window sills, and 800 μg/ft2 for

window troughs.

* * * * *

(h) Determinations. (1) Hazardous

lead-based paint is present on:

(i) All components that have paint in

poor condition and that are determined

to contain lead-based paint.

(ii) All components that have paint in

poor condition and that are similar to

and have a similar painting history to a

tested component that contains leadbased paint.

(2) A dust-lead hazard is present on:

(i) Uncarpeted floors and interior

window sills when the weighted

arithmetic mean lead loading for all

single surface or composite samples of

uncarpeted floors and interior window

sills are equal to or greater than 50 μg/

ft2 for uncarpeted floors and 250 μg/ft2

for interior window sills;

(ii) Uncarpeted floors or interior

window sills in an unsampled

residential dwelling unit in a multifamily dwelling, if a dust-lead hazard is

present on uncarpeted floors or interior

window sills, respectively, in at least

one sampled residential unit on the

property.

(iii) uncarpeted floors or interior

window sills in an unsampled common

area in a multi-family dwelling, if a

dust-lead hazard is present on

uncarpeted floors or interior window

sills, respectively, in at least one

sampled common area in the same

common area group on the property.

(3) A soil-lead hazard is present when

the arithmetic mean lead concentration

from a composite sample (or arithmetic

mean of composite samples) from the

dripline and a composite sample (or

arithmetic mean of composite samples)

from the mid-yard for each residential

building on a property is equal to or

greater than 2,000 parts per million.

5. In § 745.325, by revising paragraphs

(d)(2)(iii), by redesignating (d)(2)(iv) and

(d)(2)(v) as (d)(2)(v) and (d)(2)(vi),

respectively, and by adding paragraphs

(d)(2)(iv) and (e), to read as follows:

§ 745.325 Lead-based paint activities:

State and Tribal program requirements.

* * * * *

(d) * * *

(2) * * *

(iii) Risk assessments consist of at

least:

(A) An assessment, including a visual

inspection, of the physical

characteristics of the residential

dwelling or child-occupied facility;

(B) Environmental sampling for lead

in paint, dust, and soil;

(C) Environmental sampling

requirements for lead in paint, dust, and

soil that allow for comparison to the

lead-based paint hazard standards

established or revised by the State or

Indian Tribe pursuant to paragraph (e)

of this section; and

(D) A determination of the presence of

lead-based paint hazards made by

comparing the results of visual

inspection and environmental sampling

to the lead-based paint hazard standards

established or revised by the State or

Indian Tribe pursuant to paragraph (e)

of this section.

(iv) The program elements required in

§ 745.325(d)(2)(iii)(C) and (D) shall be

adopted in accordance with the

schedule for the demonstration required

in paragraph (e) of this section.

(v) * * *

* * * * *

(e) The State or Indian Tribe must

demonstrate that it has lead-based paint

hazards standards, and clearance

standards for dust, that are at least as

protective as the standards in § 745.227

as amended on [Insert date of

promulgation of the final rule]. A State

or Indian Tribe with such a section 402

program approved before [Insert date 2

years following date of promulgation of

the final rule] shall make this

demonstration no later than the first

report submitted pursuant to

§ 745.324(h) after [Insert date 2 years

following date of promulgation of the

final rule]. A State or Indian Tribe with

such a program submitted but not

approved before [Insert date 2 years

following date of promulgation of the

final rule] may make this demonstration

by amending its application or in its

first report submitted pursuant to

§ 745.324(h). A State or Indian Tribe

submitting its program on or after [Insert

date 2 years following date of

promulgation of the final rule] shall

make this demonstration in its

application.

[FR Doc. 98–14736 Filed 6–2–98; 8:45 am]

BILLING CODE 6560–50–F