Friday,

January 5, 2001

Part III

Environmental

Protection Agency

40 CFR Part 745

Lead; Identification of Dangerous Levels

of Lead; Final Rule

1206 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 745

[OPPTS–62156H; FRL–6763–5]

RIN 2070–AC63

Lead; Identification of Dangerous

Levels of Lead

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is issuing a final

regulation under section 403 of the

Toxic Substances Control Act (TSCA),

as amended by the Residential LeadBased Paint Hazard Reduction Act of

1992, also known as ‘‘Title X (ten),’’ to

establish standards for lead-based paint

hazards in most pre-1978 housing and

child-occupied facilities. This

regulation supports the implementation

of regulations already promulgated, and

others under development, which deal

with worker training and certification,

lead hazard disclosure in real estate

transactions, requirements for lead

cleanup under State authorities, lead

hazard evaluation and control in

Federally-owned housing prior to sale

and housing receiving Federal

assistance, and U.S. Department of

Housing and Urban Development (HUD)

grants to local jurisdictions to perform

lead hazard control. In addition, today’s

action also establishes, under authority

of TSCA section 402, residential lead

dust cleanup levels and amendments to

dust and soil sampling requirements

and, under authority of TSCA section

404, amendments to State program

authorization requirements. By

supporting implementation of the major

provisions of Title X and by providing

guidance to all owners and occupants of

pre-1978 housing and child-occupied

facilities, this regulation will help to

prevent lead poisoning in children

under the age of 6.

DATES: This final rule is effective on

March 6, 2001. This rule shall be

promulgated for purposes of judicial

review at 1 p.m. eastern daylight time

on February 5, 2001.

FOR FURTHER INFORMATION CONTACT: For

general information contact: Barbara

Cunningham, Director, Office of

Program Management and Evaluation,

Office of Pollution Prevention and

Toxics (7401), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW,

Washington, DC 20460; telephone

number: 202–554–1404; e-mail address:

TSCA-Hotline@epa.gov.

For technical information contact:

Dave Topping, National Program

Chemicals Division (7404), Office of

Pollution Prevention and Toxics,

Environmental Protection Agency, 1200

Pennsylvania Ave., NW., Washington,

DC 20460; telephone number: (202)

260–7737; e-mail address:

topping.dave@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you must comply with other Title X

regulations that are affected by today’s

action. The following table identifies

potentially affected categories and

entities:

Category Examples of Entities

NAICS or

SIC

codes

Effect of Regulation

Lead abatement professionals Workers, supervisors, inspectors, risk

assessors, and project designers

engaged in lead-based paint activities.

562910 Provides standards that risk assessors would

use to identify hazards and evaluate clearance tests; helps determine when certified

professionals would need to be employed to

perform lead cleanup

Training providers Firms providing training services in

lead-based paint activities

611519 Provides standards that training providers would

have to teach in their courses

Federal agencies that own residential

property

92511,

92811

Standards identify hazards that Federal agencies or purchasers of Federal property would

have to abate in pre 1960 housing prior to

sale, under Title X, section 1013.

Property owners that receive assistance through Federal housing programsState and city public housing authorities, owners of multifamily rental

properties that receive projectbased assistance, owners of rental

properties that lease units under

HUD’s tenant-based assistance program

53110,

531311

Standards identify hazards that property owners

would have to abate or reduce as specified

by regulations issued by HUD under authority

of Title X, section 1012

Property owners Owner occupants, rental property

owners, public housing authorities,

Federal agencies

531110,

531311

Standards identify hazards that, when known,

would have to be disclosed under EPA/HUD

joint regulations promulgated under Title X,

section 1018

This listing is not intended to be

exhaustive, but rather provides a guide

for entities likely to be affected by this

action. Other types of entities not listed

in the table in this unit could also be

affected. To determine whether you or

your business is affected by this action,

you should carefully examine the

applicability provisions in relevant

regulations. If you have any questions

regarding the applicability of this action

to a particular entity, consult the

technical person listed in the FOR

FURTHER INFORMATION CONTACT section.

B. How Can I Get Additional

Information, Including Copies of this

Document or Other Related Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, by

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1207

going directly to the Internet Home Page

for this regulation at http://

www.epa.gov/lead/leadhaz.htm and

selecting the desired document. You can

also go directly to the Federal Register

listings at http://www.epa.gov/fedrgstr/

to obtain a copy of this final rule.

2. In person. The Agency has

established an official record for this

action under docket control number

OPPTS–62156. The official record

consists of the documents specifically

referenced in this action, any public

comments received during the comment

period, and other information related to

this action. This official record includes

the documents that are physically

located in the docket, as well as the

documents that are referenced in those

documents. The public version of the

official docket, which includes printed,

paper versions of any electronic

comments submitted during the

comment period, is available for

inspection in the TSCA Nonconfidential

Information Center, North East Rm. B–

607, Waterside Mall, 401 M St., SW.,

Washington, DC. The Center is open

from noon to 4 p.m., Monday through

Friday, excluding legal holidays. The

telephone number for the Center is (202)

260–7099.

II. Overview

A. Introduction

The Title X term ‘‘lead-based paint

hazard’’ is intended to identify leadbased paint and all residential leadcontaining dusts and soils regardless of

the source of the lead, which, due to

their condition and location, would

result in adverse human health effects.

One of the underlying principles of Title

X is to move the focus of public and

private sector decision makers away

from the mere presence of lead-based

paint, to the presence of lead-based

paint hazards, for which more

substantive action should be undertaken

to control exposures, especially to

young children. This regulation

establishes hazard standards for

residential lead-based paint, and

residential dust and soil lead. The

hazard standards for these three media,

collectively, are statutorily defined as

lead-based paint hazards.

B. Summary of Statutory Authority

The Residential Lead-Based Paint

Hazard Reduction Act of 1992 was

enacted as Title X of the Housing and

Community Development Act of 1992.

Title X establishes a comprehensive

Federal program for reducing the risks

from lead-based paint and certain lead

hazards. The Title X program primarily

gives authority to HUD and EPA, but

affects a number of other Federal

agencies. Among other things, Title X

amended TSCA by adding TSCA Title

IV, which specifically gives regulatory

authority to EPA to cover, among other

things, training of workers who deal

with lead-based paint hazard abatement,

the appropriate form of State and Tribal

lead programs, and the identification of

dangerous levels of lead. Title IV

includes section 403. EPA is

promulgating the standards for leadbased paint hazards under the authority

of TSCA section 403, 15 U.S.C. 2683.

Section 403 requires EPA to

promulgate regulations that ‘‘identify . .

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

entire Title X. Lead-based paint hazards,

under TSCA section 401 (15 U.S.C.

2681), are defined as conditions of leadbased paint and lead-contaminated dust

and soil that ‘‘would result’’ in adverse

human health effects (15 U.S.C.

2681(10)). Lead-based paint is defined

by statute as paint with lead levels equal

to or exceeding 1.0 milligrams per

square centimeter (mg/cm2) or 0.5% by

weight (see section 302(c) of the LeadPoisoning Prevention Act (42 U.S.C.

4822(c)) and TSCA section 401(9) (15

U.S.C. 2681(9)). TSCA section 401

defines lead-contaminated dust as

‘‘surface dust in residential dwellings’’

that contains lead in excess of levels

determined ‘‘to pose a threat of adverse

health effects’’ (15 U.S. C. 2681(11)).

TSCA section 401 defines leadcontaminated soil as ‘‘bare soil on

residential real property that contains

lead at or in excess of levels determined

to be hazardous to human health’’ (15

U.S.C. 2681(12)).

EPA is also promulgating

amendments to the regulations for leadbased paint activities under the

authority of TSCA section 402 (15

U.S.C. 2682) and to the State and Tribal

program authorization requirements

under authority of TSCA section 404 (15

U.S.C. 2684). These changes are needed

to ensure consistency among the various

regulations covering lead risks under

TSCA. Section 402 requires EPA to

promulgate regulations establishing

training and certification requirements

for individuals and firms engaged in

lead-based paint activities. Lead-based

paint activities, in the case of target

housing and child-occupied facilities,

include risk assessment, inspection and

abatement. See TSCA section 402(b)(1);

15 USC 2682(b)(1). To clarify this

definition, EPA notes that lead-based

paint activities do not include interim

controls. These regulations ‘‘shall

contain standards for performing leadbased paint activities, taking into

account reliability, effectiveness, and

safety’’ (15 U.S.C. 2682(a)(1)). Section

404 requires States and Tribes seeking

to administer and enforce standards,

regulations, or other requirements under

section 402, 406, or both to seek

authorization from EPA.

C. Guiding Principles

Reducing exposure to lead has been

an important issue for EPA for more

than 2 decades. Young children are

especially vulnerable to the toxic effects

of lead because their nervous systems

are still developing and they absorb

more of the lead to which they are

exposed. Many of the health effects

associated with lead are thought to be

irreversible. Moreover, the effects at

lower levels of exposure are often

asymptomatic. In light of the impacts on

children and the nature of the health

effects, EPA’s goal is to eliminate

exposure to harmful levels of lead. This

goal has informed Agency actions such

as the decision to remove lead as an

additive from gasoline as discussed in

the preamble to the proposed rule (63

FR at 30305).

First and foremost, the Agency faces

the difficulty of determining the level at

which to set the standards given the

uncertainties in information on cause

and effect--what environmental levels in

which specific medium may actually

cause particular blood lead levels that

are associated with adverse health

effects. The Agency has tools, which are

only generally consistent, that show that

certain increases in environmental lead

levels are associated with certain

increases in blood lead levels. Given the

range of uncertainty shown in its

analysis supporting the establishment of

a hazard level under this rule, EPA has

developed a technical analysis that

considers hazard standards for dust and

soil at the lowest levels at which the

analysis shows that across-the-board

abatement on a national level could be

justified. EPA recognizes, however that

for any levels of lead in dust or soil

judgment must be exercised as to how

to treat the medium, and interim

controls as well as abatement could be

effective. In addition, EPA recommends

that organizations and individuals

consider some form of interim control in

certain residential areas even where soil

lead levels are below the hazard

standard if there is a concern that

children under 6 might spend

substantial time in such areas, or there

is potential for that soil to contribute to

hazardous lead levels in play areas or

dwellings. While the risks from lead at

these lower levels are less than the

hazard level, EPA believes that public

health will be further protected if

1208 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

owners and occupants of residential

properties are encouraged to take

actions to reduce the potential for lead

exposure.

In performing its analyses for this

rule, the Agency could not

quantitatively compare interim control

strategies with abatement strategies

because there are only limited data

available on the effectiveness of interim

controls over extended periods of time,

and those data which are available are

not suitable for quantitative

comparisons with abatements. In

comparing interim control strategies

with abatement strategies, one must

make a number of assumptions

concerning the costs of administrative

management, and frequency of

monitoring and renewal over the

planning horizon. For the 50–year

planning horizon which the Agency

used in its dust and soil analyses, one

would have to compare the time stream

of interim control expenses, for as long

as such expenses are necessary, and

weigh the possible differences in

potential blood-lead reductions, to make

a fair comparison of abatement and

interim control strategies.

Nevertheless, experience with interim

control programs is increasing and

certain organizations, particularly

public health and housing agencies,

believe they have been able to develop

effective programs for interim controls

which achieve virtually the same degree

of risk reduction as do abatement

programs, but at much reduced cost.

EPA received comments on this issue

during the public comment process.

EPA wishes to encourage the continuing

evaluation of such efforts because

resources to deal with hazardous lead

levels are often limited, and strategies

which achieve comparable risk

reduction, but at much reduced cost,

have the potential to protect more

children by allocating the limited

resources more effectively. EPA believes

that public and private organizations

should evaluate both interim control

and abatement strategies in determining

the most effective course of action when

dealing with dust and soil hazards.

In addition, EPA recommends that

organizations and individuals consider

some form of interim control response

action in certain areas even where soil

lead levels are below the hazard

standard. This would apply if there is a

concern that children under the age of

6 spend substantial time in such areas,

or there is potential for that soil to

contribute to hazardous lead levels in

play areas or dwellings. While the risks

from lead at these lower levels are less

than at the hazard level, EPA believes

that public health will be further

protected if owners and occupants of

residential properties are aware of such

contamination and are encouraged to

take actions to reduce the potential for

lead exposures.

For determining a paint lead hazard

EPA faced a data problem different from

that faced with respect to dust and soil

hazards. For dust and soil, EPA had

substantial raw data on environmental

levels and blood lead levels, even

though it faced substantial uncertainty

in correlating the levels. For lead-based

paint, as discussed later in this

preamble, the Agency had no data by

which it could select a threshold below

which the paint would not be a hazard.

EPA, therefore, could not apply the

same analysis for the paint hazard

determination as it did for the dust and

soil hazard determinations. Comments

indicated that even very tiny amounts of

deteriorated lead-based paint are

sufficient in certain circumstances to

result in adverse health effects.

Accordingly, EPA has generally

designated any amount of deteriorated

paint as a lead-based paint lead hazard.

Nevertheless, as with dust and soil

hazards, EPA would not recommend

full scale abatement be undertaken for

all paint lead hazards. Instead, the

Agency wishes the public to be aware

that any deteriorated lead-based paint

presents enough of a risk that it should

be stabilized and carefully monitored if

it is not abated.

Controlling exposure to lead in the

residential environment presents EPA

with challenges that, in important

respects, are different from and often

more complex than those the Agency

deals with in other regulatory contexts.

Among the challenges of this regulation

is that it requires the Agency to address

exposure from the past use of products

that contained lead rather than current

products and/or processes that

introduce lead into the environment.

Assuming that there are safe and

available substitutes, the government

can eliminate lead from an existing

product if the risk warrants such

removal (e.g., gasoline, solder for water

pipes and food cans). Removing lead

that is already in the environment is far

more difficult. It would have been better

that lead never found its way into paint

that exists today in approximately 64

million homes. However, since it is so

pervasive, EPA is faced with a number

of dilemmas. First, the number of

properties that have some form of lead

is enormous. However, the number of

buildings with lead paint an dust that

present a hazard is, relatively, much

lower. The Agency must therefore

distinguish which of these lead

conditions need to be controlled.

Because there is a great deal of

variability among properties containing

lead paint, our ability to identify which

properties present risks is limited.

Moreover, the exposure risk to

individuals, even if there were not such

a large number of affected properties,

can be compounded by child-specific

factors (e.g., hand-to-mouth behavior,

pica, nutrition, hygiene).

In addition, the success of the

program will largely rely upon the

voluntary participation of States and

Tribes, as well as counties and cities, to

implement the program and upon

property owners to follow the standards

and EPA’s recommendations. If EPA

were to set unreasonable standards (e.g.,

standards that would recommend

removal of all lead from paint, dust, and

soil), States and Tribes may choose to

opt out of the Title X lead program and

property owners may choose to ignore

EPA’s advice, believing it lacks

credibility and practical value.

Consequently, EPA needed to develop

standards that would protect children

without wasting resources by chasing

risks of negligible importance and that

would be accepted as reasonable by

States, Tribes, local governments, and

property owners.

Three other considerations also merit

the public’s attention. First, as noted,

the standards are designed to focus

resources on the worst problems. If

property owners are able to address less

pressing problems (e.g., deteriorated

paint below the minimum area

threshold), EPA encourages them to take

action. EPA also encourages States,

Tribes, and local governments to adopt

more stringent standards if local

circumstances warrant such action.

Second, the standards alone cannot

solve the lead problem. They are part of

a broader program designed to educate

the public and raise public awareness,

empower and protect consumers, and

provide helpful technical information

that professionals can use to identify

and control lead hazards. EPA has

developed and implemented an active

public education and outreach program

consisting of a toll-free hotline (1–800–

424–LEAD) co-sponsored with HUD and

U.S. Centers for Disease Control and

Prevention (CDCP), public service

announcements, poster campaigns,

distribution of a parent’s guide through

grocery stores, slides in movie theaters,

and an outreach campaign with the

National Parent Teachers Association,

the National Association of Child Care

Providers, and public libraries.

Consumer empowerment and

protection efforts include the hazard

disclosure regulations jointly issued

with HUD training and certification

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1209

standards for individuals and firms

engaged in lead-based paint activities,

and the pre-renovation education rule

that requires renovation and remodeling

contractors to provide the EPA

pamphlet ‘‘Protect Your Family from

Lead in Your Home’’ to occupants prior

to the start of renovation and

remodeling projects. In addition, under

section 402 of TSCA, EPA is currently

developing training and certification

requirements for renovation and

remodeling contractors whose activities

may create lead hazards.

EPA and other Federal agencies

continue to conduct field studies to

identify and evaluate lower cost

products and technologies for

evaluating and controlling lead-based

paint hazards. The findings of these

studies are distributed to professionals

through our lead hotline, EPA’s website

(www.epa.gov/lead) and at other

agencies’ websites, and through ongoing contact with trade and

professional associations. The

standards, combined with these other

efforts, provide a comprehensive

program designed to reduce and

eventually help eliminate lead in

residential paint, dust, and soil as a

cause of childhood lead poisoning.

Third, these standards are based on

the best science available to the Agency.

EPA recognizes, however, that the

science is constantly developing and

with it our understanding of the

relationship between lead in the

environment and human exposure and

the relationship between exposure and

health impacts. If new data become

available (e.g., empirical data showing

that very small amounts of deteriorated

paint pose a serious health risk or data

showing that hazard control activities

are more effective at reducing long-term

dust-lead levels than assumed by EPA),

the Agency will consider changing the

standards to reflect these data. If the

data indicate that the standards should

be changed and they meet EPA’s quality

criteria, the Agency will consider

publishing the data for public review

and comment and amending today’s

regulation.

D. Regulatory Approach

1. Uniform national standards. EPA is

issuing uniform national standards in

this rule. The rationale for adopting

uniform national standards is found on

pages 63 FR 30307 to 30308 of the

preamble to the proposed rule. EPA

summarizes this reasoning in the

following paragraphs.

EPA stated that the relationship

between environmental lead levels

(from paint, dust, and soil) and their

effects on the health of exposed

children, which forms the basis for this

rule, is complex, and is dependent upon

numerous site-specific and childspecific factors. Where more sitespecific factors can be considered on a

smaller (residence or community) scale,

estimates of the effects of environmental

levels on blood lead can be more

accurate. The data needed, however, are

not available for communities

nationwide. In contrast, national data on

lead in paint, dust, and soil are

currently available. Even if data were

available, the residence or community

scale standards would still not account

for variability in exposure influenced by

child-specific factors (e.g., hand-tomouth behavior, hygiene, and

nutrition). Detailed evaluations that

considered the specifics of individual

communities would generally require

information for each residence to

evaluate the impact of environmental

lead on children.

In addition, uniform national

standards provide a fixed basis of

comparison for all homes. National

standards can be used to compare

properties and establish priorities. This

would be extremely difficult to

accomplish if there were the numerous

standards specific to individual

communities.

EPA also took into account that

certain segments of the population have

a higher incidence of elevated bloodlead levels (e.g., minority and lowincome children). Because estimates of

the relationship between environmental

lead levels and children’s health effects

are not sufficiently refined to

distinguish relationships for particular

subsets of the general population of

children, EPA is choosing to emphasize

program implementation (e.g., training,

education, and environmental justice

grants), which the Agency considers a

more effective and simpler approach to

address vulnerable communities rather

than setting community-specific

standards. EPA preferred to establish a

simple, set of standards that could

easily be adopted by States, allowing

them to tailor the standards, should they

so choose. This allows States greater

flexibility to establish and implement

their programs while a national,

baseline level of protection to children

is maintained.

2. Media-specific standards. A second

basic issue that shaped EPA’s standardsetting approach involves the fact that a

child’s total lead exposure is the sum of

contributions from numerous sources,

including paint, dust, soil, and others.

Specifically, EPA had to decide whether

to set separate, independent standards

for paint, dust, and soil or to integrate

the standards.

Under the first option, EPA would

establish a fixed standard for each

medium without considering the

varying conditions in the other media.

For example, the soil standard would

remain constant, regardless of whether

dust lead levels were high or low. The

chief advantage of this option is that the

standards are simple to understand and

use.

A potential disadvantage of this

approach is that a standard could be

established for a particular medium that

does not consider the total exposure of

a child (i.e., exposures from all other

media). To address this potential

shortcoming, the Agency considered

candidate sets of standards for dust,

lead, and paint together so that its

comparisons of candidate standards

reflected exposures to all media.

Consequently, the standards, although

they are medium-specific numbers will

effectively identify hazards as long as all

media are evaluated and compared to

the standards.

Under the second option, EPA would

set standards to account for total lead

exposure from all media. Under a joint

standard, the standard for each medium

would vary, depending on the

conditions in the other media. For a

graphical [illustration of this option, see

page 30308 of the preamble to the

proposed rule. The major advantage of

the joint standards is that they avoid

anomalous situations. For example, it

stands to reason that if both dust and

soil measurements are just below the

hazard levels--35 μg/ft2 on the floor and

1,175 parts per million (ppm) in the

non-play area--the situation is more

dangerous than if one measurement is

above the hazard level--e.g. 1,225 ppm

for soil--and floor dust is at zero. Yet the

first set of measurements would not

constitute a hazard and the second set

would. In these circumstances, joint

standards may better reflect the total

exposure and risk. Furthermore, for this

option to be truly effective, EPA would

need to know the levels from all sources

of lead exposure and how they relate to

blood lead levels individually and in

various combinations. EPA, currently,

lacks the analytical tools to support

selection of joint standards. In addition,

EPA is endeavoring to set the media

specific hazard standards low enough

that hazardous situations will not occur

if both soil and dust are just below the

standards. In such a case, the media

specific standards could be

overinclusive. The Agency, however,

believes that this approach is

appropriate to protect public health.

Accordingly, in this rule EPA is

establishing media-specific standards.

Additional explanation for this decision

1210 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

can be found on pages 30308 and 30309

of the preamble to the proposed rule.

E. Applicability and Uses of the

Standards

The standards established in this rule

apply to target housing (i.e., most pre1978 housing) and child-occupied

facilities (pre-1978 non-residential

properties where children under the age

of 6 spend a significant amount of time

such as daycare centers and

kindergartens). The standards are

intended to be used prospectively. That

is, they should be used to identify

properties that present risks to children

before children are harmed. This, of

course, would not prevent them from

being used retrospectively in the case of

environmental intervention blood lead

investigations and clearance of resulting

lead hazard control activities.

These standards are not appropriate

as the sole source of information to use

when identifying the source of exposure

for a lead-poisoned child. When a

property is being evaluated in response

to an identification of a lead-poisoned

child, the risk assessor in cooperation

with local public health officials should

identify and consider all sources of lead

exposure. For example, a risk assessor

should consider lead in drinking water

as well as the presence of any amount

of deteriorated lead-based paint.

Within the scope of Title X, these

regulatory standards will help support

and implement major provisions of the

statute. They will be incorporated into

the risk assessment work practice

standards, providing the basis for risk

assessors to determine whether leadbased paint hazards are present. By

helping to determine when a hazard is

present, the standards will help

determine when a hazard control

activity must be performed by certified

personnel. EPA further notes that only

abatement of lead-based paint hazards

specifically hazardous lead-based paint,

dust-lead hazards or soil-lead hazards

identified in 40 CFR 745.65 requires

certified personnel. This is because

‘‘abatement’’ is defined in 40 CFR

745.223 as ‘‘measures designed to

permanently eliminate lead-based paint

hazards.’’ Thus, permanent elimination

of lead-based paint, and dust or soil lead

would not require the use of certified

personnel unless lead-based paint

hazards are present in those media.

States and Tribes wishing to obtain or

retain authorization to administer and

enforce training and certification

programs must incorporate hazard

standards as protective as the standards

in this rule. Provisions for State and

Tribal authorization are described at 40

CFR part 745, subpart Q. These

standards will also help property

owners comply with section 1018 by

establishing what conditions must be

disclosed to prospective purchasers and

renters as lead-based paint hazards

prior to the sale or rental of target

housing. HUD, the Department of

Defense (DoD), and other Federal

agencies will use these standards in

implementing or overseeing the

evaluation and control of hazards in

Federally-assisted housing and

Federally-owned housing prior to

disposition. (24 CFR part 35)

Under section 1018 of Title X (42

U.S.C. 4852d), EPA and HUD have

jointly developed regulations requiring

a seller or lessor of most pre-1978

housing to disclose the presence of any

known lead-based paint and lead-based

paint hazards to the purchaser or lessee

(24 CFR part 35, subpart A; 40 CFR part

745, subpart F). When these section 403

rules become effective, lead-based paint

hazards in lead paint, dust or soil will

need to be disclosed. EPA further notes,

however, that under the section 1018

rules, the seller or lessor also must

provide the purchaser or lessee any

available records or reports ‘‘pertaining

to’’ lead-based paint, lead-based paint

hazards and/or any lead hazard

evaluative reports available to the sellor

or lessor (section 1018(a)(1)(B). See 40

CFR 745.107(a)(4). Accordingly, if a

seller or lessor has a report showing

lead is present in levels that would not

constitute a hazard, that report must

also be disclosed. Thus, disclosure is

required under section 1018 even if dust

and soil levels are less than the hazards.

EPA notes, however, that with respect

only to leases of target housing,

disclosure is not required in the limited

circumstance where the housing has

been found to be lead-based paint free

by a certified inspector (24 CFR 35.82;

40 CFR 745.101), although voluntary

disclosure of such certifications is

encouraged.

Beyond the scope of Title X, these

standards will guide the control of leadbased paint hazards in the nation’s

housing stock.

Although other regulations (e.g.,

hazard evaluation and control in

housing receiving Federal assistance

and Federally-owned housing prior to

sale) may require property owners to

evaluate properties for the presence

and/or control of lead hazards, today’s

action does not contain such

requirements. Specific requirements are

determined by the particular State,

Federal, and local government

regulations which mandate actions

when health hazards are found in target

housing or child-occupied facilities.

EPA, however, strongly recommends

that property owners or other decision

makers take appropriate actions to

reduce or eliminate hazards. Finally, the

standards provide property owners and

other decision makers with the Federal

government’s best judgement

concerning lead dangers in residential

paint, dust, and soil.

The standards were established

assuming that property owners and

other decision makers would identify

and control hazards in all three media

(i.e., paint, dust, and soil). Failure to

take a multimedia approach may not

provide adequate protection to children.

First, the protectiveness of the standards

assumes that all media will be

appropriately addressed. Second, failure

to address one or more medium leaves

children at risk from exposure to lead in

media that are not addressed. Third,

failure to address one or more media

reduces the effectiveness of hazard

control actions that are taken due to

recontamination of one media from lead

in another. Fourth, the Agency believes

that soil can be a source of exposure

whenever it is accessible for either

incidental ingestion or tracking into a

home, and that while grass and other

coverings may be effective in

significantly reducing potential

exposures, such coverings must be

maintained in order to provide

continuing protection.

F. Summary of the Final Rule

1. Hazardous lead-based paint

(§ 745.65(a)). The hazard standard for

lead-based paint, called the ‘‘paint lead

hazard,’’ is any of the following:

a. Any lead-based paint on a friction

surface that is subject to abrasion and

where the lead dust levels on the

nearest horizontal surface underneath

the friction surface are equal to or

greater than the dust hazard levels.

b. Any damaged or otherwise

deteriorated lead-based paint on an

impact surface that is caused by impact

from a related building component.

c. Any chewable lead-based paint

surface on which there is evidence of

teeth marks.

d. Any other deteriorated lead-based

paint in residential buildings or childoccupied facility or on the exterior of

any residential building or childoccupied facility.

The purpose of identifying almost all

deteriorated lead-based paint as a paint

lead hazard is to alert the public to the

fact that all deteriorated lead-based

paint should be addressed--through use

of paint stabilization or interim controls.

Something less than abatement and

certified personnel, however, would be

needed to undertake interim controls or

to abate lower levels of deterioration.

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1211

Two existing HUD and EPA rules

provide the applicable standards: HUD

rules under sections 1012 and 1013 of

Title X published on September 15,

1999 (61 FR 50140), and EPA work

practice rules under section 402 of

TSCA published on August 29, 1996 (61

FR 45778) (FRL–5389–9). In general,

these rules provide that occupant

protection procedures, clearance testing,

use of certified personnel or other

similar specialized lead hazard control

practices and procedures are not

required if one or more of the following

conditions exist:

a. Two square feet or less of

deteriorated lead-based paint in a room.

b. Twenty square feet or less of

deteriorated exterior lead-based paint;

c. Ten percent of the total surface area

on an interior or exterior type of

component with a small surface area

consist of deteriorated lead-based paint.

2. Dust standards. Today’s regulation

includes two standardsfor dust: hazard

levels for floors (including carpeted

floors) and interior window sills

(§ 745.65(b)) and clearance standards for

floors (including carpeted floors),

interior window sills, and window

troughs (§ 745.227(e)(8)(viii)). The dustlead hazard standards are 40 μg/ft2 for

floors based on a weighted average of all

wipe samples and 250 μg/ft2 for interior

window sills based on a weighted

average of all wipe samples. The

weighted average, or weighted

arithmetic mean, means the arithmetic

mean of sample results weighted by the

number of subsamples in each sample.

Its purpose is to give influence to a

sample relative to the surface area it

represents.

The clearance standards for dust

following an abatement are 40 μg/ft2 for

floors, 250 μg/ft2 for interior window

sills, and 400 μg/ft2 for window troughs.

The dust-lead level must be less than

the applicable standard for the surface

to pass clearance. Clearance standards

are used to evaluate the effectiveness of

cleaning following an abatement, and

EPA may also use these standards in

future rulemakings to evaluate the

effectiveness of cleaning following a

renovation and remodeling project.

Properties that undergo abatement must

pass clearance according to the work

practice standards for abatement found

at 40 CFR 745.227. If a property fails

clearance, it must be recleaned until it

passes, although it is not automatically

necessary to reclean the entire property

when clearance fails, such as when

some of the visual and dust-testing

clearance results have indicated that

portions of the property are already

cleared.

3. Soil standards. Today’s regulation

establishes the following standards for

bare residential soil: a hazard standard

of 400 ppm by weight in play areas

based on the play area bare soil sample

and an average of 1,200 ppm in bare soil

in the remainder of the yard.based on an

average of all other samples collected.

See § 745.65(c). The final rule also

identifies lead-contaminated soil as soil

with levels equal to or greater than these

soil-lead hazard standards.

Property owners and other decision

makers should implement effective

measures to reduce or prevent

childrens’ exposure to lead in soil that

exceeds these levels. These measures

may incorporate, but are not limited to,

interim controls that include covering

bare soil and placement of washable

doormats in entryways. The need for

more permanent controls should be

determined with consideration of local

conditions and usage patterns, the

relative risks from different lead

sources, and the potential for exposures

to change over time.

4. Summary of other actions. Today’s

rule also amends existing regulations for

lead-based paint activities including:

a. Requirements for interpreting the

results of a lead-based paint risk

assessment sampling for purposes of

determining if lead-based paint hazards

are present.

b. Changes to the risk assessment

work practice standards at 40 CFR

745.227 to require testing of all

deteriorated paint on surfaces with a

distinct painting history to determine if

the paint is lead-based.

c. Changes to the dust and soil

sampling locations in the risk

assessment work practice standards at

40 CFR 745.227.

d. Work practice standards for the

management of soil removed during an

abatement.

e. Amendments to the State and

Tribal program authorization

requirements under 40 CFR part 745,

subpart Q; and

f. Amendment to the definition of

‘‘abatement’’ at 40 CFR 745.223 to make

it clear that abatement does not include

removal of paint, dust, and soil unless

lead-based paint hazards are present in

those media.

G. Limitations of the Hazard Standards

As stated in the proposed rule (63 FR

at 30304), there is significant confusion

about the requirements and purpose of

the TSCA section 403 regulations.

Consequently, EPA felt it necessary in

the preamble to the proposed rule to

highlight major limitations and other

issues related to the scope and use of

the regulation. These statements

continue to apply. To summarize, the

regulation does not establish a new

definition for lead-based paint. The

hazard standards apply to conditions

observed when the risk assessment was

performed. The standards do not

address the potential for a hazard to

develop. The standards apply to target

housing, but may be used as guidance

for other residential property. Finally,

the standards are intended to identify

dangerous levels of lead, not housing

that is free from risks associated with

exposure to lead.

As stated in Unit II.F.3., today’s rule

establishes two hazard standards for

bare residential soil; 400 ppm for play

areas and an average of 1,200 ppm for

the rest of the yard. EPA recommends

that organizations and individuals

consider some action in certain areas

even where levels in bare soils are

below the hazard standard, particularly,

if there is a concern that children 6

years and under might spend substantial

time in such areas, or if there is concern

that the bare soil in such areas may

contribute to lead levels in the dwelling,

or in the play areas. However, this rule

does not mandate that any action be

implemented when levels are found to

be below the lead hazard standard.

Moreover, the kind of response that

organizations and individuals might

consider could include modest actions

such as planting grass (or other ground

cover) to more extensive actions such as

covering the bare soil with several

inches of clean fill.

As indicated in Unit II.E., it is also

important to emphasize that this rule

only applies to pre-1978 target housing

and certain child-occupied facilities,

and that these standards were not

intended to identify potential hazards in

other settings. If one chooses to apply

the hazard level to situations beyond the

scope of Title X, care must be taken to

ensure that the action taken in such

settings is appropriate to the

circumstances presented in that

situation, and that the action is adequate

to provide any necessary protection for

children exposed. See also Unit IV.D.

for a discussion regarding the

relationship of the soil hazard standard

to Superfund soil cleanup standards.

H. Preamble Overview

The remainder of this preamble

consists of four units. Unit III. presents

an explanation of the Agency’s

decisions. It includes a summary of the

proposal, identifies the major changes

between the proposed and final rules,

and explains the changes. Unit IV.

presents a discussion of some of the

more significant issues raised by the

public comments. Unit V. contains the

1212 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

references for sources used in this

preamble. Unit VI. is the regulatory

assessment unit, which deals with the

Federal requirements for agency

rulemaking that are imposed by various

statutes and executive orders. Unit VII.

discusses the Congressional Review Act

requirements.

III. Explanation of the Agency’s

Decisions

A. Summary of the Proposed Regulation

EPA published the proposed

regulations on June 3, 1998 (63 FR

30302) (FRL–5791–9). The proposed

standard for hazardous lead-based paint

was lead-based paint in poor condition,

defined as more than 10 ft2 of

deteriorated lead-based paint on exterior

components with large surface areas,

more than 2 ft2 of deteriorated leadbased paint on interior components

with large surface areas, or deteriorated

lead based paint on more than 10% of

the total surface area of interior or

exterior components with small surface

areas. Lesser amounts of deteriorated

paint were considered de minimis levels

and were not considered hazards. The

proposed standard for a dust lead

hazard was the average level of lead in

dust that equals or exceeds 50 μg/ft2 on

uncarpeted floors and 250 μg/ft2 on

interior windows sills. The proposed

standard for soil-lead hazard was lead

that equals or exceeds 2,000 ppm based

on a yard-wide average soil-lead

concentration. A soil-lead level of

concern, proposed to be 400 ppm, was

included in draft guidance but not in

the proposed regulation. The statutory

basis for the level of concern was the

section 403 requirement that EPA

identify ‘‘lead-contaminated soil,’’

which the Agency interpreted to be a

level less than the soil-lead hazard. EPA

used the term ‘‘level of concern’’ instead

of ‘‘lead-contaminated soil. EPA

proposed that lead-based paint hazards

be identified by certified risk assessors

performing risk assessments according

to the work practice standards at 40 CFR

745.227.

The June 3, 1998 document also

proposed amendments to existing

regulations for lead-based paint

activities including:

1. Clearance standards for dust

following an abatement of 50 μg/ft2 for

uncarpeted floors, 250 μg/ft2 for interior

window sills, and 800 μg/ft2 for window

troughs.

2. Requirements for interpreting the

results of a lead-based paint risk

assessment sampling for purposes of

determining if lead-based paint hazards

are present.

3. Changes to the dust and soil

sampling locations in the risk

assessment work practice standards at

40 CFR 745.227.

4. Work practice standards for the

management of soil removed during an

abatement; and

5. Amendments to the State and

Tribal program authorization

requirements under 40 CFR part 745,

subpart Q.

B. Summary of Significant Changes

from the Proposed Regulation and Other

Major Decisions

This section of the preamble briefly

presents the major changes between the

proposal and final rule. EPA also

identifies major provisions of the

proposed regulation that remain

unchanged in the final rule. Unit II.D. of

the preamble presents the Agency’s

explanation for these decisions.

1. Dust standards. The final rule

changes the lead-based paint hazard

standard for dust, known as the dustlead hazard, and the standard for dust

clearance for floors to 40 μg/ft2. In

addition, the dust-lead hazard will

apply to all floors, including carpeted

floors. It will not be limited to bare

floors. The final rule does not change

the dust-lead hazard for interior

window sills. Today’s action lowers the

clearance level for window troughs from

the proposed 800 μg/ft2 to 400 μg/ft2. In

addition, the final rule modifies the

method for interpreting composite dust

clearance samples. Under the proposed

rule, the result of the composite sample

would have been compared to the

clearance level divided by the number

of subsamples in the composite. The

final rule requires the result of the

composite sample to be compared to the

clearance level divided by half the

number of subsamples in the composite.

2. Soil standards. With respect to the

soil standards, there are several changes

from the proposed rule. First, EPA is not

establishing any distinction between

lead-contaminated soil (soil lead ‘‘level

of concern’’) and soil-lead hazards.

Instead, EPA is, in the preamble, simply

identifying lead-contaminated soil as

soil with levels equal to or greater than

the soil-lead hazard standards. For

purposes of this rule ‘‘leadcontaminated soil’’ is the same as a

‘‘lead-based paint hazard’’ based on soil

lead.’’

Second, in the final rule EPA is

establishing the lead-based paint hazard

standard for bare soil, known as the soillead hazard standard, to have one

hazard level for play areas and another

for the remainder of the yard. The

proposed rule did not give special

attention to play areas and made the

hazard determination based on the

whole yard only. From the proposed

2,000 ppm for bare soil in the entire

yard, EPA is setting a final soil-lead

hazard of 400 ppm for bare soil in play

areas and an average of 1,200 ppm for

bare soil in the non-play area portion of

the yard.

3. Paint standards. The paint

component of the lead-based paint

hazard standards is known as the paintlead hazard. The paint-lead hazard

consists of three standards: Deteriorated

lead-based paint; lead-based paint on

friction and impact surfaces; and leadbased paint on accessible (chewable)

surfaces.

a. Deteriorated paint. EPA considers

that, in general, any deteriorated leadbased paint needs to be addressed and

should be considered a paint-lead

hazard. Accordingly, in the final rule

the Agency does not have a de minimis

level of deteriorated paint for the paintlead hazard. Instead, the final rule

simply refers to work practice and

certification regulations issued by HUD

and EPA that apply to dealing with

paint-lead hazards. These regulations

provide that occupant protection

procedures, clearance testing, use of

certified personnel or other similar

specialized lead hazard control

practices and procedures are not

required at lesser levels of paint

deterioration. These specific levels of

deterioration are (i) Two square feet or

less of deteriorated lead-based paint per

room; (ii) twenty square feet or less of

deteriorated exterior lead-based paint;

(iii) ten percent of the total surface area

on an interior or exterior type of

component with a small surface area.

b. Friction and impact surfaces. The

standard in the final rule for the paintlead hazard on friction surfaces is leadbased paint that is subject to abrasion

where the lead dust levels on the

nearest horizontal surface underneath

the friction surface are equal to or

greater than the lead-dust hazard levels.

The paint-lead hazard for impact

surfaces is any damaged or otherwise

deteriorated paint on an impact surface

that is cause by impact from a related

building component. No minimum area

threshold of paint deterioration applies

to friction or impact surfaces. In the

proposed rule, EPA did not include a

preferred option for these surfaces. The

Agency, instead, solicited public

comment on a range of options

including: Lead-based paint regardless

of condition on a friction/impact

surface; abraded lead-based paint on a

friction/impact surface; and no separate

standard.

c. Surfaces accessible for chewing or

mouthing. The standard for the paintVerDate 11<MAY>2000 13:46 Jan 04, 2001 Jkt 194001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 E:\FR\FM\05JAR3.SGM pfrm03 PsN: 05JAR3
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lead hazard on accessible surfaces,

referred to as ‘‘chewable’’ surfaces in the

final rule, is any chewable lead-based

paint surface on which there is evidence

of teeth marks. No minimum area

threshold applies to deteriorated leadbased paint on accessible surfaces. In

the proposed rule, EPA did not include

a preferred option for these surfaces.

The Agency, instead, solicited public

comment on a range of options

including: Lead-based paint regardless

of condition on interior window sills up

to 5 feet off the floor; and no separate

standard for accessible surfaces. EPA

has eliminated the 5–foot requirement.

4. Requiring certified risk assessors to

determine the existence of lead-based

paint hazards. The final rule does not

include a requirement that the presence

of lead-based paint hazards must be

determined by certified risk assessors

following the risk assessment work

practice standards at 40 CFR 745.227.

C. Explanation of the Agency’s

Decisions

In this section of the preamble, EPA

provides its reasons for choosing the

final TSCA section 403 standards for

lead-based paint hazards (which

includes paint-lead, dust-lead, and soillead hazards) and its final determination

for what constitutes lead-contaminated

dust and residential soil. In addition,

EPA provides its reasons for

establishing the clearance levels for

household dust--measures of dust in

lead that will show that hazards have

been appropriately cleaned.

The choice of the particular

methodologies used to develop each of

these standards constitutes another

important set of decisions. Hazard levels

for dust and soil were developed using

an analysis of risk, the potential for risk

reduction (considering uncertainties in

the data and scientific evidence

describing the risks), and the cost of

reducing risk. In determining the paintlead hazard, EPA has decided that any

deteriorated lead-based paint would

result in adverse health effects, based on

information submitted in public

comments and other information in the

rulemaking record. The Agency has

been unable to determine any level of

deteriorated lead-based paint that

should not be considered a paint-lead

hazard.

The general outline of these

methodologies is referred to in later

sections of this Unit and, where

applicable, incorporates into the final

rule those decisions made in the

preamble to the proposed rule.

1. Basis for dust and soil standards.

As a preliminary matter, EPA has found,

after considering all significant public

comments and all other information in

the rulemaking record, that the legal

interpretations and policy decisions in

the preamble to the proposed rule form

the basis for the final decisions

discussed in this preamble, except as

indicated below. EPA hereby

incorporates, for purposes of this final

rule, the relevant reasoning and

analyses from the proposed preamble, as

indicated below. Any modifications to

the analyses or reasoning from the

preamble to the proposed rule will be

specifically explained in this preamble,

the Reponse to Comment (RTC)

document, or other documents in the

record, and are supported by the record

for the final rule.

a. Legal basis. Details of the basic

legal structure of Title X and the legal

effect of the issuance of regulations

under TSCA section 403, including the

responsibilities of EPA and HUD, are set

forth in the preamble to the proposed

rule (63 FR 30306) and need not be

repeated here. There EPA provided a

detailed discussion of its views at the

time of the statutory mandate and the

statutory criteria, including the

Agency’s interpretation of relevant

terms and the statutory basis for the

Agency’s decision to use particular

criteria to develop the determination for

what constitutes lead-contaminated dust

and lead-contaminated soil and the

hazard standards for dust, soil and paint

at (63 FR at 30311–30315). EPA has

modified some of these interpretations

and retains others, as discussed below.

EPA needs to define three terms

under TSCA section 403, ‘‘lead-based

paint hazards,’’ ‘‘lead-contaminated

dust’’ and ‘‘lead-contaminated soil.’’

Lead-based paint hazards consist of

lead-contaminated paint, leadcontaminated dust and leadcontaminated soil that ‘‘would result’’

in adverse health effects.

Section 401(9) of TSCA provides a

definition of lead-based paint, which

EPA interprets to be lead-contaminated

paint for purposes of this rule. EPA

noted that lead-based paint is not, under

the statute, a risk-based term, but only

a benchmark that identifies material

subject to jurisdiction of the authorities

of TSCA and Title X. Not all lead-based

paint is a hazard, only that paint which

EPA determines ‘‘would result’’ in

adverse health effects. EPA has

determined, as discussed below, that the

dust and soil levels designated as leadbased paint hazards are also identified

as ‘‘lead-contaminated dust’’ and ‘‘leadcontaminated soil.’’ This equating of

dust and soil contamination with ‘‘leadbased paint hazards’’ caused by dust

and soil lead represents a change from

the reasoning in the preamble to the

proposed rule. EPA’s reasons for this

change are discussed below.

EPA generally refers to the hazards in

each of the media as ‘‘paint-lead

hazards,’’ ‘‘dust-lead hazards’’ and

‘‘soil-lead hazards.’’

i. Decision on contaminated dust and

soil. While section 403 obligates the

Agency to identify lead-based paint

hazards, lead contaminated dust, and

lead-contaminated soil, the legislative

history and statutory text are themselves

silent on how Congress intended the

Agency to differentiate between the

standard for soil contamination (the

level of lead in soil determined to be

hazardous to human health), dust

contamination (the level of lead in dust

that poses a threat of adverse health

effects in pregnant women or young

children), and the levels of

contaminated dust or soil that constitute

a lead-based paint hazard (a condition

that would result in adverse human

health effects). Further, the terms ‘‘leadcontaminated dust’’ and ‘‘leadcontaminated soil’’ have no significance

under either TSCA or Title X except

insofar as the level of contaminated dust

or soil constitutes a ‘‘lead-based paint

hazard’’.

In the proposed rule EPA considered

that, because the statute required the

identification of ‘‘lead contaminated’’

dust and soil, the Agency needed to

establish separate levels for these terms

than for ‘‘lead-based paint hazards’’

resulting from contaminated dust or

soil. Furthermore, EPA proposed, based

on the statutory language and the

structure of the statute, that the

determination of whether dust or soil

were contaminated required less

certainty than whether such dust or soil

constituted a hazard. See 63 FR 30311-

12. In the preamble to the proposed rule

EPA set the ‘‘contamination’’ levels,

then called ‘‘levels of concern,’’ at those

levels the Agency determined could

result in a 1 to 5% probability of an

individual child’s exceeding a blood

lead level of 10 μg/dL. See 63 FR 30316-

30317.

EPA noted, however, that the terms,

‘‘lead-contaminated’’ dust and soil have

no direct effect on any activities subject

to regulation under Title X. For

example, no certification requirements

are imposed for persons who remove

lead-contaminated soil, only for those

who remove soil associated with soillead hazards. Because the

contamination levels do not affect other

activities under Title X or TSCA Title

IV, EPA proposed not to include them

in the regulatory language. EPA only

proposed to adopt in guidance to

accompany the final rule a separate

level for lead-contaminated soil of 400

1214 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

ppm for the entire yard. EPA did not

propose to adopt a separate standard for

contaminated dust, since it found

substantial overlap in its analysis and

could not distinguish between dust-lead

contamination and dust-lead hazards.

EPA received a significant number of

comments criticizing the establishment

of these ‘‘contamination’’ levels,

particularly for soil, primarily because

setting two levels for ‘‘contamination’’

and ‘‘hazard’’ would confuse the public.

Other comments claimed EPA had no

authority to establish separate

contamination levels, as opposed to

hazard levels.

While the Agency clearly has

authority to establish separate levels for

contaminated dust and soil, given the

comments, the lack of clear statutory

direction, and the lack of significance of

the terms in the statutory structure, the

Agency has determined not to establish

any separate levels for contaminated

dust or soil beyond those levels that

constitute a lead-based paint hazard.

The Agency believes it sufficient for

purposes of TSCA and Title X to

conclude that, at a minimum, the

quantity of lead in dust or soil found to

result in conditions that cause exposure

to lead that would result in adverse

human health effects (i.e., constitutes a

lead-based paint hazard) is ‘‘leadcontaminated dust’’ and ‘‘leadcontaminated soil,’’ respectively.

Accordingly, for purposes of this

regulation, the dust and soil levels

designated as lead-based paint hazards

are also identified as ‘‘leadcontaminated dust’’ and ‘‘leadcontaminated soil’’.

ii. Weight of evidence for dust and

soil hazard standards. EPA’s dilemma

in determining what constitutes dustlead and soil-lead hazards is based on

the Agency’s recognition that any

determination of hazard requires a great

deal of judgment in the case of lead

health risks where, ‘‘as a practical

matter, all the scientific evidence is

uncertain to some degree . . .’’ (See

preamble to the proposed rule at 63 FR

30313.) Making judgments on the

science varies to a large extent with

respect to three issues: How to

determine which blood lead levels are

truly hazardous; how to interpret the

statutory language ‘‘result in adverse

human health effects,’’ when

uncertainties exist; and how best to

account for uncertainties in the risk

analyses that relate environmental lead

levels to blood lead levels and the

prevalence data that is used in this

analysis.

The resolution of these issues, at best,

produces a continuum where, at one

end, blood and environmental levels

exist that everyone would agree

constitute a hazard. At the other end,

approaching blood lead levels in the

general population (averaging lower

than 5 μg/dL) or typical environmental

levels (generally, less than the hazard

levels found in this regulation), greater

uncertainty exists on how to model the

likelihood of health effects. This is

compounded by having to factor in

uncertainties of the effects of both blood

lead levels and the associated

environmental levels. This is because,

even if EPA has confidence in the blood

lead levels of concern, the Agency still

faces the uncertainty of associating

blood lead with environmental levels in

each medium, as well as possible effects

from other sources--for example, water

and air emissions.

In addressing the first issue, the

Agency has chosen 10 μg/dL as the

blood-lead level of concern. This value

is equal to the level of concern

recommended by the CDCP and the

Agency’s reasons for choosing this value

are explained in the next section of this

preamble.

As to the second issue, the challenge

to the Agency is how to deal with the

statutory criterion, ‘‘would result in

adverse human health effects.’’ This is

especially problematic because the

statutory mandated activity that requires

EPA to choose a cutoff for when this

risk exists does not lend itself to a

straightforward empirical analysis that

provides bright lines for decision

makers. Even if the science and

environmental-lead prevalence data

were perfect, there would likely be no

agreement on the level, or certainty, of

risk that is envisioned in the phrase

‘‘would result in adverse human health

effects.’’ Thus, it would not be

appropriate to base a lead-based paint

hazard standard on any specific

probability of exceeding any specific

blood-lead level.

The Agency therefore elected to take

a pragmatic approach to setting the

hazard standards namely, evaluating the

amount of risk reduction that the hazard

standards could provide. That is, rather

than trying to select standards based

solely on model-based probability

distributions (which is even further

complicated by the fact that different

models produce different results), the

Agency looked at the consequences of

the standards based on the assumption

that, if EPA calls something a ‘‘leadbased paint hazard,’’ all persons would

act rationally in their own best interests

and would permanently eliminate

(abate) these hazards before a child is

about to become exposed to them. This

is the so-called ‘‘normative’’ analysis

referred to in the preambles to the

proposed and final rule and discussed

in detail in the economic analyses and

preambles for the proposed and final

rules. (EPA’s analysis for using this

method for determining what

constitutes dust and soil hazards is

discussed in detail in the preamble to

the proposed rule at 30312-15. That

analysis is incorporated as the final

interpretation of the Agency on this

matter and will not be repeated in great

detail here. Later in this preamble, EPA

responds to the various public

comments on its analysis of the

appropriate method for determining

dust and soil lead-hazards under TSCA

section 403.)

Also, identification of lead-based

paint hazards under this regulation is

sure to have impacts that could be

expensive even though the range of

expenses is, itself, difficult to resolve

because of the uncertainty of individual

behavior and the willingness of

individuals to accept risks that EPA may

identify. Thus, if EPA were to choose

standards that are too low, the public

could be unable to distinguish between

trivial risks at the low levels of lead

from the more serious risks at higher

levels. This could result in clean up for

little to no health benefit, or conversely,

it could result in almost no clean up

because persons would question the

credibility of the ‘‘hazard’’

determination. Thus, they may ignore

even those high risk situations that need

to be controlled. On the other hand, if

the Agency chooses standards that are

too high, actual adverse effects could

occur at levels below that. EPA’s

dilemma is to draw this line.

Based on the language of section 403,

the purposes of Title X and its

legislative history, and basic policy

decisions, EPA determined that it was a

reasonable exercise of its discretion to

draw this line based on consideration of

the potential for risk reduction of any

action taken (considering uncertainties

in the data and the scientific evidence

describing the risks) and whether such

risk reductions are commensurate with

the costs of those actions. This is

commonly referred to as cost-benefit

balancing. In this rule, EPA used costbenefit balancing to assist in identifying

the hazard standards. This method was

useful because available data run

through various models showed a range

of environmental levels that could be

associated with a particular blood-lead

level (the surrogate used to approximate

risk) and the potential reduction in

blood-lead concentration/risk that could

result from eliminating or controlling

the environmental level. Given this

range, EPA used cost-benefit balancing

to assist in selecting the specific

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1215

standards for this rule from within the

range bounded by the results of the

models.

Using this approach, the Agency is

better able to deal with the third issue

identified above how to best consider

and account for the strengths and

weaknesses of its risk assessment tools

and data. For example, in estimating the

number of homes that would be

identified as hazards at various

environmental lead levels, the Agency

relied upon data from the HUD National

Survey. Obviously, when assessing the

impacts of standards at lower

environmental lead levels, estimates are

more likely to be inaccurate due to the

presence of outliers in the data than

would be the case in the middle range

of the data. Additionally, the Agency

must consider the range of exposures

over which its models relating

environmental lead to blood lead can be

expected to perform well and the

sensitivity of those models to the data

inputs. By considering at which points

in its analyses the data and models are

strongest and weakest, the Agency can

identify where in its analyses the

greatest levels of certainty exist.

Consideration of these factors is

described in section 3.b., which

discusses the selection of the dust and

soil hazard levels.

b. Choosing the lowest candidate

hazard standards. While EPA is no

longer considering the determination of

what constitutes lead-contaminated dust

or soil to be governed by different

standards from those used in the

determination of what constitutes dust

or soil-lead hazards, the analysis used in

the proposal to determine the

contamination standards is still relevant

to the consideration of options for the

hazard standards. This is because the

effect of choosing the proposed dust and

soil lead contamination standards based

on a 1 to 5% probability of an

individual child’s having blood lead

levels exceeding 10 μg/dL was to

establish the lowest candidate hazard

standards. In the proposal, this was for

dust 50 μg/ft2 on uncarpeted floors and

250 μg/ft2 for sills and for soil 400 ppm

in the entire residential yard. Additional

analysis, as noted below in discussion

of the dust and soil hazard level

determination, was applied to actually

develop the hazard standards.

Furthermore, as noted above, the

determination of which blood lead

levels are truly hazardous (the blood

lead level of concern) was the first

scientific issue EPA had to decide in

selecting dust and soil lead hazards.

Accordingly, EPA adopts as the basis

determining the lowest candidate

standards for the final dust and soil lead

hazards the same policy basis used in

the proposal for choosing dust and soil

lead contamination levels--a 1 to 5%

probability of a child’s developing a

blood lead level of 10 μg/dL.

The choice of 10 μg/dL is based on a

significant body of scientific evidence,

extensively cited in the preamble to the

proposed rule, that shows that a number

of significant health effects manifest

themselves in the 10-15 μg/dL range.

EPA hereby incorporates as the basis for

its final decision on the blood lead

concentration of concern all relevant

discussions in the preamble to the

proposed rule, particularly the

discussion at 63 FR 30316-17. The

Agency’s decision is supported by past

statements made by the Clean Air

Science Advisory Committee and is

consistent with Federal policy

established by the CDCP and the

recommendations of the National

Academy of Sciences (NAS). The

Agency wishes to emphasize, as it stated

in the proposed rule, that this choice

does not imply that 10 μg/dL is a

threshold level. On the contrary, EPA

maintains its position that there is no

known threshold for lead. EPA decided

not to use a level lower than 10 μg/dL

because the evidence indicates that

health effects at lower levels of exposure

are less well substantiated, based on a

limited number of children, and

observation of subtle molecular changes

that are not currently thought to be

sufficiently significant to warrant

national concern.

The choice of probability is based on

the Agency’s interpretation of the

statute and the limits of EPA’s analytical

tools. The Agency rejected the lowest

possible probability, which is zero. Even

without lead-based paint and leadcontaminated soil and dust, there could

be some small mathematical probability

that a child could still have a blood-lead

level equaling or exceeding 10 μg/dL.

This is because other sources of

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

background levels of lead) remain.

Because under the statute EPA may only

account for risks associated with paint,

dust and soil, a zero exceedence

probability would not make sense for

this rule.

In addition, EPA’s assessment for this

rule indicates that, as a practical matter,

in the context of establishing on a

national level the initial candidate for

the hazard level, the probabilities that

given environmental levels of lead

‘‘would result’’ in blood lead levels of

concern, 1% is not distinguishable from

5% in estimating risks from soil lead.

This is because, within the context of

the analyses for this rule, there was

substantial overlap in estimates of risk

from soil lead within the 1 to 5% risk

range. This overlap is due to the

uncertainty and variability related to

EPA’s analyses to associate low levels of

lead in a specific environmental

medium to blood-lead concentrations

and limited data. For example, results

from models used to relate

environmental levels to blood lead

levels vary depending upon what is

assumed about the interrelationship

between dust and soil. Also, in the

performance characteristics analysis

(explained below), the number of

children was small, yielding similar

results for a 1% exceedence as for a 5%

exceedence. In effect, EPA is setting the

exceedence probability as close to zero

as it is able (within analytical limits of

its analyses) for the effects of lead paint

and lead in dust and soil.

In addition, given the data and

analytical tools available to support this

rulemaking, the Agency determined

that, as a practical matter, 1% is not

distinguishable from 5%. This overlap

is due to the uncertainty and variability

related to any effort to associate low

levels of lead in a specific

environmental medium to blood-lead

concentrations and limited data. For

example, in the performance

characteristics analysis, the number of

children was small, yielding similar

results for a 1% exceedence as for a 5%

exceedence. In effect, EPA is setting the

exceedence probability as close to zero

as it is able (within analytical limits of

its analyses) for the effects of lead paint

and lead in dust and soil.

At the other end of the range

considered by EPA was an exceedence

probability of 10%. With this

distribution of risk, a child would have

approximately a 2% chance of having a

blood-lead concentration exceeding 15

μg/dL and a less than 1% chance of

having a blood-lead concentration

exceeding 20 μg/dL, the level at which

CDC recommends medical intervention.

In the proposal’s discussion of the

contamination standard, the Agency

rejected this probability as presenting

exceedingly high risks. For

determination of a hazard level, they

would also be excessively high. EPA

believes it is inconsistent with the

statute to establish a hazard standard at

which significant numbers of children

would need medical treatment.

c. Basis for the dust and soil hazard

standards. As explained in the preamble

to the proposal, EPA used cost-benefit

balancing to establish a range of options

for hazard standards. EPA then selected

its preferred options based on

consideration of relevant factors,

including the assumptions and tools

underlying EPA’s analysis, health

1216 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

protectiveness, cost, and the effect on

the overall lead risk reduction program

(63 FR at 30314–30315). The Agency

refers the public to the proposal for the

detailed discussion of its reasoning for

choosing the approach to develop the

hazard standards. EPA’s approach for

using cost benefit analysis is described

in the proposed rule and is used for the

final rule.

In this document, EPA wishes to

highlight several points that merit

special attention. First, the various

modeling techniques used by EPA only

established a range of possible answers

upon which the Agency exercised its

administrative judgement. EPA used its

quantitative modeling as a tool to

establish the boundaries of the Agency’s

inquiry, not as the sole basis for

decisions. Because precise values

cannot be assigned to risks (or costs),

any cost-benefit balancing is

appropriately used to help select an

option within a range for the hazard

standards. The Agency then selected its

preferred options, from within the range

bounded by the modeling results, 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.

To support the establishment of a

range of options, EPA used a normative

analysis which assumes that all hazards

to young children will be identified and

controlled. EPA adopted this approach

not only in view of the obvious

imprecision in its ability to estimate

how the public will actually respond in

terms of the number and scope of

hazard control interventions that will be

implemented in response to the

standards, but also with the objective of

allowing Agency decision-makers to

compare costs and benefits. Thus, while

the Agency can only estimate the

theoretically possible costs and benefits

associated with each option, not the

actual costs and benefits, EPA is

confident that the relative balance of

costs and benefits estimated is unlikely

to be very different from the relative

balance of actual costs and benefits.

Finally, EPA wishes to emphasize that

there is no set way to apply the

balancing of costs and risk reduction.

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. As

stated in the preamble to the proposed

rule and as adopted in today’s final rule,

the determination on soil standards

considers the fact that relatively high

costs may 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.

EPA recognizes that resources for

abatement to address lead risks to

children are often limited and that

societies often have to set priorities.

Therefore, establishing numerically low

national standards could serve to dilute

resources across more properties and

communities instead of steering

resources to address situations that

present clearer, more certain risk. Along

the same line of reasoning, the Agency

believes that it is sound public policy

for the hazard standard to embody a

‘‘worst first’’ approach that will aid in

setting priorities to address the greatest

lead risks promptly.

With respect to the paint component,

data limitations prevented EPA from

quantifying the costs and benefits of the

options considered in the proposal (as

well as for the final rule). Consequently,

EPA’s decisions with respect to the

options for the paint component

involved a more qualitative judgment on

the part of the Agency in the proposal,

as well as in the final rule. Later in this

unit, EPA explains its decision for

identifying what constitutes hazardous

lead based paint.

2. Technical analyses. To support the

development of the dust and soil hazard

standards in this rule, EPA required

tools to relate lead in the environment

to blood-lead concentration. As

described in the proposal to the

proposed rule, EPA used several

methods for this purpose: a mechanistic

model that has been calibrated and

validated with various empirical dataset

and which simulates the body’s

response to lead exposure, and both

modeling and non-modeling analyses of

empirical data from the Rochester Lead

in Dust Study. The mechanistic model

is the Agency’s Integrated

Environmental Uptake and Biokinetic

(IEUBK) model. The empirical data used

in the modeling and non-modeling

analysis to support this rule was

obtained from a study of lead in

Rochester, New York entitled

‘‘Rochester Lead-in-Dust Study.’’ The

preamble to the proposed rule (63 FR

30315 ) contains a general overview of

these tools. Given the uncertainties and

limitations associated with any single

approach, EPA decided that it would be

helpful to obtain several perspectives

(with different associated strengths and

weaknesses) on the relationship

between environmental lead and blood

lead levels.

EPA thoroughly evaluated its choice

of methods in response to public

comments and all other information

available to the Agency. EPA has

concluded that it is appropriate to use

the same methodology for its final

decision. Based upon public comments

and all other information in the

rulemaking record, the Agency also

recalculated the numerical results

obtained for the proposed rule. These

recalculations did result in some

changes to the standards from those

proposed, as is explained below.

a. Initial candidate hazard levels—i.

Dust. For development of the proposed

dust-lead contamination level (referred

to as the level of concern) EPA used: A

multimedia model based on the data

from the Rochester Lead-in-Dust study

and a performance characteristics

analysis of the Rochester data. The

reasons for using these models and their

implementation is explained in the

preamble to the proposed rule (63 FR at

30317–30319) in the Units titled ‘‘c.

Characterizing individual risk.’’ and ‘‘d.

Dust analysis.’’ For purposes of this

analysis for determining the initial

candidate levels for the final hazard

standards, however, EPA judges it is

appropriate to continue to use the same

model, based on the same reasoning.

The multimedia model yielded the

following results. The levels of lead in

dust on floors associated with an

individual child having from a 1 to 5%

chance of having a blood-lead

concentration equal to or exceeding 10

μg/dL range from near zero to 6.7 μg/ft2.

The range for dust loadings on window

sills is from near zero to 74 μg/ft2.

The performance characteristics

analysis yielded the following results.

For floors, dust-lead loadings ranged

from 50 μg/ft2 to 400 μg/ft2. For interior

window sills, dust-lead loadings ranged

from 100 μg/ft2 to 800 μg/ft2. These

ranges were significantly higher than

the ranges yielded by the multimedia

approach.

The performance characteristics

analysis to support the determination

that 1 to 5% of children would develop

blood lead levels above 10 μg/dL

remains unchanged for the analysis in

this final rule. The results yielded by

the multimedia model would put the

environmental dust-lead levels at which

1-5% of children would develop blood

lead levels above 10 μg/dL at near or

below background levels and well

below the residual levels that remain

after homes have been well cleaned (i.e.,

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1217

the clearance levels). These results do

not seem to make sense to the Agency

since they imply that background levels

in well cleaned homes would still be of

concern from a risk perspective.

Therefore, based upon public

comments, the Agency reevaluated its

analyses.

Based upon this reassessment, EPA

decided to make some revisions to the

way it applied the multimedia model so

that its results would be more

comparable to the performance

characteristics analysis. This was

accomplished by using the same set of

parameters (average soil concentration,

dust on floors and sills, and paint

conditions) and the same subset of data

from the Rochester Lead-in-Dust Study.

Following these changes, the order of

magnitude difference in results between

the original multimedia model and the

performance characteristics model

virtually disappears. At 50 μg/ft2, the

performance characteristics shows a

7.5% risk of equaling or exceeding 10

μg/dL and the multimedia model shows

a 5.34% risk. At 40 μg/ft2, the

performance characteristics shows a

5.1% risk of equaling or exceeding 10

μg/dL and the multimedia model shows

a 5.30% risk. That is, under these

analyses, floor dust levels at 40 μg/ft2

correspond to 5% and less probability of

blood lead levels exceeding 10 μg/dL.

Thus, using the revised model, 40 μg/ft2

is the standard that better meets the

criteria spelled out in the Agency’s

proposal (less than 5% probability of

exceeding 10 μg/dL). EPA provides a

detailed description of this revised

analysis in the ‘‘Risk Analysis to

Support Standards for Lead in Paint,

Dust, and Soil: Supplemental Report.’’

EPA accordingly has chosen 40 μg/ft2 as

the initial candidate level for the dustlead hazard level in today’s final rule.

ii. Soil. In the proposed rule, EPA set

a ‘‘level of concern’’ based on the

Agency’s IEUBK model and a

performance characteristics analysis of

the Rochester data. The reasons for

using these models and their

implementation is explained in the

preamble to the proposed rule (63 FR

30317, 30319) in the Units titled ‘‘c.

Characterizing individual risk’’ and ‘‘e.

Soil Analysis.’’ Under the IEUBK

analysis soil-lead concentrations

generally at or below 500 parts per

million (ppm) would result in a 1 to 5%

probability that a child will have a

blood-lead concentration that equals or

exceeds 10 μg/dL. The performance

characteristics analysis for soil ranged

from 200 ppm to 1,500 ppm correlated

with 1 to 5% of children with elevated

blood lead levels exceeding 10--μg/dL.

EPA chose 400 ppm as the proposed soil

lead contamination level. EPA adopts

that same level as the initial candidate

soil hazard standard for the same

reasons as provided in the preamble to

the proposed rule for choosing 400 ppm

as the soil contamination level.

3. Dust and soil hazard levels. The

analyses to support selection of the dust

and soil hazard levels included

evaluation of the nation-wide reduction

in risk that could potentially result from

a set of hazard standards. EPA measured

the change in risk reduction in terms of

an estimated change in the national

blood-lead distribution, equated this

change to reductions in several adverse

public health outcomes (e.g., IQ point

loss), assigned a value to these

reductions, and compared these public

health benefits to the costs of hazard

intervention.

a. Methodology. EPA finds no reason

to change its methodology of using a

normative cost-benefit analysis for

developing dust-lead and soil-lead

hazards. The Agency, accordingly,

adopts the reasoning set forth in the

preamble to the proposed rule for

conducting this analysis. The general

overview of the cost-benefit analysis

and its use in decisionmaking is

provided in the preamble to the

proposal (63 FR at 30319–30320) in the

introductory paragraphs to the section

entitled ‘‘2. Dust-lead and soil-lead

hazard standards’’.

The methodology for estimating risk

reduction is found in the section

entitled, ‘‘a. Estimating risk reduction.’’

(63 FR 30320) and, partially, in the

section entitled ‘‘b. Estimating costs and

benefits.’’ (63 FR 30321). Methodology

for estimating the monetary value to be

assigned to the value of risk reduction

that may be achieved by actions taken

in response to the hazard standards is

found in the section entitled ‘‘b.

Estimating costs and benefits.’’ (63 FR at

30320–30321). Determination of the

costs of actions that may be taken to

reduce risk is in the same section at

30321-22 and in two paragraphs at 63

FR 30325 in the section entitled ‘‘c.

Results.’’ The limitations, qualifications

and uncertainties that affect both the

estimates of benefits and costs are found

at 63 FR 30322–30323 in the section

entitled ‘‘b. Estimating costs and

benefits.’’

The Risk Assessment was designed to

estimate the declines in children’s blood

lead levels that would result if

abatement and other response actions

were taken in housing units that

exceeded candidate standards for paint,

dust, and soil. While certain details of

the analysis are complex, the basic

approach is straightforward. First, a

baseline of environmental lead and

blood lead levels was established. These

represent the ‘‘pre-403’’ conditions.

For the pre-403 environmental lead

levels, the Agency used the Department

of Housing and Urban Development’s

National Survey of Lead-Based Paint in

Housing (the HUD Survey). Conducted

in 1989-1990, the HUD Survey

measured the extent and condition of

lead-based paint in housing, the amount

of lead in dust within the housing, and

the amount of lead in soil surrounding

the housing. For the pre-403 blood lead

levels, the Agency used Phase 2 of the

third National Health and Nutrition

Examination Survey (NHANES III).

Conducted by the Centers for Disease

Control and Prevention in 1991-1994,

NHANES III included measurements of

children’s blood-lead levels.

Next, the Agency estimated the

reduction in environmental lead levels

that would result if abatements or other

responses were performed in housing

units that failed candidate standards for

paint, dust, and soil. These levels

represent the ‘‘post-403’’ environmental

lead levels and rely upon estimates of

the effectiveness and duration of the

response actions.

The Agency then modeled the blood

lead levels that would correspond to the

pre- and post-403 environmental lead

levels. This allowed an estimation the

blood-lead reduction that would result

from the standards (i.e., the difference

in the blood lead levels from the pre-403

environmental levels to the post-403

environmental levels). Here, the Agency

used two different models the Integrated

Exposure Uptake Biokinetic (IEUBK)

Model and an empirical model that was

based upon the results of the Rochester

Lead in Dust Study. Consequently, there

are two different estimates of the bloodlead changes that would result from the

403 standards, one based upon each

model. Finally, the two estimates of

blood-lead changes were re-scaled by

applying the pre-403 blood-lead levels

in NHANES III. EPA repeated this

process for each set of standards under

consideration.

The two models of risk assessment

were incorporated into the economic

benefit-cost framework to generate net

benefit estimates for the various

candidate hazard standards. EPA wishes

to emphasize that it is more important

to consider the net benefit estimates

relative to each other rather than their

actual numerical value for the various

candidate hazard standards. In order to

apply these models in this national

analysis, the models relating

environmental lead to blood lead could

not reflect the consideration of sitespecific data to the extent that would be

sought when they are applied locally.

1218 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

Also, the Agency recognizes that the

costs and benefits associated with the

normative analysis are likely to

overstate the actual costs and benefits

associated with the standards since it is

likely that not everyone will follow the

rule recommendations and, to the extent

they do not, benefits and costs would

both be lower. This is not of great

concern because the objective of this

analysis 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 of the analysis, 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. Additional discussion of

how to interpret the results of the

normative cost-benefit analysis is

provided in the preamble to the

proposed rule (63 FR 30323) at the

beginning of the Unit entitled ‘‘c.

Results.’’

b. Results. The results of the analysis,

under each model, to determine dustlead and soil-lead hazards for the

proposed rule are found in the preamble

to the proposed rule (63 FR at 30323–

30325). The results of the analysis after

the reevaluation for the final rule are

presented in this section. The analysis’

computation of net benefits is the

difference between the total benefits

estimate and the total costs estimate.

Net benefits are an indicator of the

societal gains from hazard controls.

While the rule, in and of itself, does not

impose a requirement to abate the

hazards, for purposes of its risk analysis

for this rule, EPA has assumed that

abatement will be undertaken in all

homes that exceed the levels when a

child is born. This analysis does not

account for the costs and benefits

associated with child-occupied facilities

because of the lack of available data and

resources.

While the Agency has assumed that

the remediation response to the

presence of a paint, dust or soil lead

hazard is abatement (e.g., removal or

permanent covering for soil) for

purposes of its analyses, it should not be

concluded that the Agency has

identified abatement as the only viable

response to paint, soil or dust hazards.

The Agency believes that well-designed

and well-managed programs of interim

controls can achieve significant

reductions in hazards and, particularly

for soil hazards, could be less expensive

than removal.

As noted previously in this preamble,

in performing its analyses for this rule,

the Agency could not quantitatively

compare interim control strategies with

abatement strategies because there are

only limited data available on the

effectiveness of interim controls over

extended periods of time, and those data

which are available are not suitable for

quantitative comparisons with

abatements. Nevertheless, experience

with interim control programs is

increasing and certain organizations,

particularly public health and housing

agencies, believe they have been able to

develop effective programs for interim

controls which achieve virtually the

same degree of risk reduction as do

abatement programs, but at much

reduced cost. EPA believes that public

and private organizations should

evaluate both interim control and

abatement strategies in determining the

most effective course of action.

Therefore, while EPA does not have

the authority under this statute to

mandate any particular remediation

action for lead-based paint hazards, it

recommends strongly that some action

be initiated--interim controls or

abatement--if lead levels exceed the

hazard standards. Morever, if bare soillead levels are below the hazard

standard in non-play areas, the Agency

recommends that organizations and

individuals at least consider some

action in bare soil in those areas if there

is a concern that children under the age

of 6 might spend substantial time in

such areas, or there is concern that the

bare soils in such areas may contribute

to hazardous lead levels in the dwelling,

or in the play area.

The IEUBK-based analysis and the

Empirical-model-based analysis are only

used to calculate the benefits of the

various options. Costs are calculated in

the same manner for both models. Total

costs increase as options become

increasingly stringent and are mainly a

function of unit costs (costs for a single

abatement) and the number of homes

affected. Unit costs for dust are the same

whenever a dust lead hazard is present.

For soil, unit costs vary depending on

the part of the yard being addressed by

the abatement (e.g., dripline, mid-yard,

play-area) and on whether the removed

soil has to be managed as hazardous

waste under regulations under the

Resource Conservation and Recovery

Act (RCRA). The unit cost is lower for

lower soil-lead levels (below 2,000 ppm)

because it is expected that the removed

soil would not have to be managed as

hazardous waste.

In the analysis for the proposed rule,

unit costs for dust abatement were $ 391

for single-family homes and $ 262 for

multi-family units (63 FR 30324). The

preamble to the proposed rule (63 FR

30322) included the following complete

range of unit costs for soil removal and

other control actions as follows:

TABLE 1.—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 5,706 2,275

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

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1219

TABLE 1.—HAZARD EVALUATION AND CONTROL COSTS (PER ACTIVITY IN 1995 DOLLARS)—Continued

Activity Single Family Multi-family

(per unit)

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

Soil removal (play area, non-hazardous waste) 1,460 314

Soil removal (play area, hazardous waste) 2,129 359

It is important to note that, as printed

in the proposal, this table contained a

typographical error with respect to the

cost of exterior paint abatement in

single-family housing. This error was

identified and corrected in a Federal

Register document published on

December 18, 1998 (63 FR 70087) (FRL–

6048–3).

Total costs for the various options

considered are found in Tables 4, 5, 6,

and 7 of the proposal (63 FR at 30324–

30325). Similar tables, although slightly

revised as is described later in this

section, are presented as Tables 7–A1

through 7–A4 in Appendix 7 of the

Economic Analysis of the TSCA section

403 Lead-based Paint Hazard Standards

Final Rule (December 2000) (Economic

Analysis) (Ref. 14). As in the proposal,

however, these tables do not include

estimated costs or benefits of paint

interventions, or any testing or risk

assessment costs. Since only a single

standard was considered for paint

interventions, associated costs and

benefits are omitted from the tables to

permit a clearer presentation of the

incremental changes in costs and

benefits that are associated with changes

in standards for the option considered.

The Agency also omits testing and risk

assessment costs in the tables below for

a similar reason. Finally, in order to

observe the effects of intervention in

each medium separately, EPA held lead

levels in all other media constant at

baseline levels, which are based on the

HUD National Survey data. In tables 7A3 and 7A-4 for the estimated costs and

benefits for soil-lead hazard standard,

independent dust and paint

interventions are assumed not to occur.

Some dust interventions that are

triggered by soil abatements are

incorporated in these two tables.

The units of benefit and the value

being assigned to them are presented in

Table 2 below.

TABLE 2.—SUMMARY OF BENEFITS ANALYSIS ESTIMATE

Type of Effect Description Estimate Source

Effect of a Single

Point Reduction in

IQ

Sum of the direct and indirect effects on the percent of earnings

lost (2.379%) and express the

effect in terms of the present

value of average lifetime earnings

$9,360 in 1995 dollarsProduct of the estimate of the present value of average

lifetime earnings based on U.S. Department of Commerce ($366,021 (1992 $)) and the assumed percentage loss of earnings from a single point reduction in

IQ of 2.379% (Salkever 1995)

Cost of Additional

Education

Sum of the direct costs ($316) and

opportunity costs ($627) of additional education

$1,014 in 1995 dollarsSum of the estimate of the direct and opportunity costs

of additional education based on U.S. Department of

Education (1993) data

Total Effect of a Single Point Reduction

in IQ

Subtract the costs of additional

education from the effects on

earnings lost

$8,346 in 1995 dollarsAccounting for the cost of additional education was

based on Salkever (1995)

Special Education (IQ

less than 70 points)

Cost of special education beginning at age 7 and ending at age

18

$53,836 in 1995 dollarsKakalik et al. (1981) estimate annual incremental regular

classroom costs of $6,458 in 1995 dollars for special

education. This estimate is the discounted value of

such costs for age 7 through 18.

Compensatory Education (Blood lead

greater than 20)

Cost of compensatory education

beginning at age 7 and ending at

age 9

$15,298 in 1995 dollarsKakalik et al. (1981) estimate annual incremental regular

classroom costs of $6,458 in 1995 dollars for compensatory education. This estimate is the discounted

value of such costs for age 7 through 9.

Medical Intervention

(for several blood

lead ranges)

Cost of blood lead screening and

medical intervention for children

less than six years old (by blood

lead Risk Group)

Risk Group1 I:$58;

R.G. IIA: $70; R.G.

IIA: $227; R.G. IIA:

$417; R.G. IIA:

$678; R.G. IIA:

$9843; R.G. IIA:

$9843

Recommendations and actual practice based on information from CDC (1991), AAP (1995), and medical

practitioners. These estimates are the discounted

costs per newborn associated with each blood lead

Risk Group.

1(All in $1995)

1220 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

Calculations for the IEUBK-based

analysis for a range of dust hazard

options for floor dust and the soil

hazard standard options are presented

in the economic analysis (Ref 14).

Discussion of the calculations is found

at 63 FR 30323-25. The dust values for

40 μg/ft2 will be discussed later in this

preamble. Finally, the units of benefit

and the value being assigned to them in

these analyses are presented in Table 2.

In summary, total benefits increase as

options become increasingly stringent,

ranging from $ 50 billion to $ 88 billion

for dust and from $ 16 billion to $ 145

billion for soil. As discussed in the

Economic Analysis, the results

presented for soil account for the fact

that soil interventions (excluding those

in play areas only) include dust

interventions following the removal and

replacement of soil, and thus

incorporate the costs and benefits

associated with dust interventions in

addition to the costs and benefits

associated with the soil abatement itself.

Benefits increase at an increasing rate

because, as dust and soil-lead 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 600,000 to about 700,000 (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 6

million to 12 million (an increase of

about 6 million housing units).

Because total benefits increase at a

faster rate than total costs, net benefits

also increase as options become

increasingly stringent, ranging from $ 42

billion to $ 69 billion for dust and $ 13

billion to $ 103 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

ppm and increase more quickly from

3,000 ppm to 2,000 ppm and from 1,200

to 500 ppm. Net benefits increase

because total benefits are increasing at

a faster rate than total costs.

It is important to note that the above

analyses do not take into account lead

levels in other media. Controlling for

other contributors to blood lead presents

a different picture of the net benefits

that result from moving to a more

stringent standard.

Under the Empirical-model for floor

dust, total benefits increase as options

become increasingly stringent, ranging

from $ 27 billion to $ 36 billion. For sill

dust over the range of candidate

standards that were considered, net

benefits are in the maximum range at

250 μg/ft2 and are slightly higher with

floor dust standards of 50 μg/ft2 as

compared to 100 μg/ft2. 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 blood lead remains relatively

constant across the range of options

considered. The increasing number of

children protected by more stringent

standards is counter balanced by

decreasing risk reduction predicted for

children living in homes with low dust

and soil-lead levels. That is, there are

smaller changes in blood lead because

there are smaller changes in

environmental-lead between baseline

dust-lead levels and post-intervention

levels.

Of the combinations of dust standard

options evaluated in the proposal, net

benefits were relatively constant for all

the combinations except the most and

least stringent (floor = 50 μg/ft2 with sill

= 100 μg/ft2 and floor = 100 μg/ft2 with

sill = 1,000 μg/ft2, respectively). For the

other options considered, benefits and

costs increase at approximately the

same rate, resulting in little change in

net benefits. Specifically, the

combinations resulted in net benefits of

around $ 20 billion, which is also the

case when a floor standard of 40 μg/ft2

is considered.

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.

4. Selection of the standards and

other Agency decisions. This section of

the preamble presents the explanation

of EPA’s decisions regarding the

standards for dust and soil lead hazard

and paint-lead hazard standards.As part

of the discussion of the Agency’s

decisions for each media, EPA is also

presenting its decisions on related

issues including sampling location and

interpretation. The dust section will

also include a discussion of the dust

clearance standards, and the soil section

will include EPA’s decision regarding

management of soils removed during

abatement.

The clearance standards for dust,

interpretation of composite clearance

samples, soil management practices,

and sampling location requirements are

not being issued under authority of

section 403 of TSCA, but under the

work practice standards of section 402.

Therefore, the legal reasoning, policy

decisions, and technical analyses

explained above do not have direct

applicability to their promulgation. EPA

is presenting these issues in this unit for

public convenience, in order to keep all

its decisions regarding each medium in

one place in this preamble.

a. Dust—i. Dust-lead hazard

standards. EPA has decided to adopt a

dust-lead hazard standard 40 μg/ft2 for

floors and 250 μg/ft2 for interior window

sills) in the final rule. The floor

standard is changed somewhat from the

proposal but the window sill standard

remains the same as for the proposal.

According to the Empirical modelbased analysis for the proposal, the

results of which are summarized in

Table 6 of the proposed rule, 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 considered

in the proposed rule, the 50/250 μg/ft2

standard was found to be the most

protective in terms of the amount of risk

reduction yielded. The other three

options, though less costly, also

provided less risk reduction. The

decrease in both costs and benefits as

the combination of floor and sill options

become less stringent were roughly the

same (between $5 billion and $6

billion), resulting in little change in net

benefits.

EPA’s decision on the proposed floor

standard was further supported by the

results of the IEUBK model-based

normative analysis, summarized in

Table 4 of the preamble to the proposed

rule, which showed that the net benefits

for the proposed floor standard were

greater than those for a less stringent

standard; net benefits estimated by this

analysis increased from $ 48 billion for

100 μg/ft2 to $ 61 billion for the

proposed 50 μg/ft2 standard.

EPA reiterates that this normative

cost-benefit analysis has been

undertaken for comparative purposes

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1221

only to evaluate the hazard standards on

a relative basis. However it does not

mean to imply that billions of dollars

will be spent on lead dust cleanup

because the responses projected in the

cost estimates may not necessarily

reflect the behavior of residents and

building owners over 50 years. These

costs also reflect some extremely

conservative assumptions, such

assuming that all yards are potentially

affected even if they actually contain no

bare soil. 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.

EPA decided to propose the 50 μg/ft2

and 250 μg/ft2 standards respectively for

floors and sills because the Agency

preferred to select the most protective of

the four combinations.

In the proposal, the Agency did not

consider a floor standard option less

than 50 μg/ft2 because, in its risk

analysis, EPA’s best estimate was that

the post-intervention dust-lead loading

would be the lower of the preintervention dust-loading or 40 μg/ft2.

This was the Agency’s best estimate of

dust levels that would remain after

controlling sources of lead and

thoroughly cleaning the residence. It

was based on an analysis of data from

several abatement studies which is more

fully discussed in Chapter 6 of the

Agency’s risk analysis (Risk Analysis to

Support Standards for Lead in Paint,

Dust, and Soil, EPA 747–R–97–3006,

June 1998) (Ref. 12). in the record for

the proposed rule. In light of this

estimate, EPA found it would be

impractical to set the standard for floors

lower than 40 μg/ft2 because little or no

risk reduction would likely to be

achieved for homes that had dust-lead

loadings at or below 40 μg/ft2.

In the preamble to the proposed rule,

EPA stated that, if new data were to

become available before promulgation of

the final rule that show that even lower

post-intervention dust-lead loadings

could be achieved, EPA would consider

establishing a more stringent dust-lead

hazard standard. A number of

comments were submitted claiming that

cleanup could be achieved below 40 μg/

ft2. Of particular relevance were

comments from HUD stating that, in its

experience, cleaning to levels below 40

μg/ft2 was typically achieved as

evidenced by its Grantees program. In

fact, since the proposal of this rule,

HUD has promulgated a 40 μg/ft2

standard for floors in its 1012/1013

regulations. Since EPA’s basis for not

considering a standard less than 50 μg/

ft2 was based upon its understanding of

the effectiveness of cleaning and, based

upon the data provided by HUD in its

comments, it is now clear that a 40 μg/

ft2 standard is achievable, the Agency is

establishing 40 μg/ft2 as the dust-lead

hazard standard for floors. The Agency

believes that this is consistent with the

approach taken in its proposal namely,

that the floor-dust hazard standard

should be at the lower end of the range

where risk reduction is possible.

Further, when considered in terms of its

cost-benefit analysis, EPA found that

indeed positive net benefits resulted for

the 40 μg/ft2 hazard standard. In fact, as

compared to the proposed standard of

50 μg/ft2 with a sill dust standard of 250

μg/ft2 (see Tables 2 and 4), net benefits

are somewhat higher under the IEUBK

model-based analysis and

approximately the same under the

Empirical model-based analysis.

EPA does not believe it is appropriate

to set a dust-lead hazard below this

level for the additional reason that such

a level would significantly increase the

number of homes identified as lead

hazards and would not likely identify

more truly hazardous environments.

This is based on the fact that these

lower levels would identify significantly

more than the approximately 22 million

homes that are identified as having

dust-lead hazards under the 40 μg/ft2

standard. In view of the fact that there

are far less children in the population

with elevated blood lead levels, EPA has

to question modeling results that would

suggest such lower levels.

ii. Carpeted floors. In contrast to the

proposed standards that only applied to

uncarpeted floors, EPA has decided to

include carpeted floors in the dust-lead

hazard standard, and the clearance

standards. EPA’s reasoning is explained

herein.

The Agency received substantial

comment on the issue of the floor dust

standard, and its proposed limitation to

uncarpeted floors. As discussed in the

preamble for the proposed rule (63 FR

30336), EPA did not include dust

standards for carpeted floors because

the Agency was 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 such relationship, EPA felt it

could not estimate the level of risk and

risk reduction that would be associated

with various levels of dust-lead in

carpeted floors. Furthermore, EPA did

not believe it had adequate data on the

effectiveness of carpet cleaning that

would be needed to establish a dust

clearance level for carpeted floors. EPA

did state that it planned to analyze

expeditiously any newly available data

to establish dust standards on carpeted

floors and to amend the regulations to

add standards for carpeted floors.

EPA, however, acknowledged that the

lack of standards for carpeted floors was

a significant limitation of the proposal.

Accordingly, the Agency requested

comment on the impact of not including

standards for carpeted floors and

indicated it would be interested in any

information or data that would help it

establish such standards.

Almost all comments on this issue

disagreed with EPA’s decision not to set

carpet standards, even though many

recognized that the lack of data on

hazardous levels of lead in carpets

makes it difficult for EPA to establish a

dust-lead standard for carpeted floors.

However, by excluding carpet dust from

the dust hazard standard EPA will cause

excessive amounts of lead to be ignored

during dust-lead control activities.

Many children who live in homes with

wall-to-wall carpeting will remain

unprotected from floor dust-lead

hazards. Using data from the 1997

American Housing Survey, EPA

estimates that approximately 54 million

housing units built prior to 1978 contain

some wall-to-wall carpeting. Of these

units, wall-to-wall carpeting is found in

a living room in approximately 47

million units and in a bedroom in

approximately 46 million units (i.e.,

rooms in which children reside and

play most frequently.

A number of comments pointed out

the unintended consequences of not

having a dust-lead standard for carpets.

Contractors complained that, because

abatement requires quality control

standards in order to be properly

executed, many contractors will refuse

to work in rooms where there is no

standard on which they can fall back to

show they have done their work

correctly. This could raise liability

issues because there would be no

standard to determine whether it is safe

for a family to return to a home after a

lead cleanup. Not having a carpet

standard could create the notion that, if

carpet remains, there is no hazard on

the floors and the carpeted floor can be

ignored. Further, a property owner

could avoid having to meet clearance

levels for lead dust on floors simply by

laying carpet.

In view of the substantial loophole

that could be created in the absence of

a standard for carpeted floors, many

comments recommended that EPA

1222 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

should maintain one standard for all

floors until research can be done that

supports a different standard for

carpeted floors. The Agency is

persuaded by the comments that the

absence of any standard at this time

would potentially lead to significant

exposures for children, and that some

standard is necessary at this time.

In response to these concerns, the

Agency has reviewed the information

submitted by commenters and other

information in its rulemaking record,

including the data base supporting the

floor dust-lead standard. EPA agrees

with the comments that the huge

potential loophole created by not having

a carpet standard could affect large

numbers of children and would be

inappropriate. It is known that carpeting

can be a dust reservoir with significant

amounts of lead. In addition, the

Agency believes that its rulemaking

record supports setting a carpet

standard that is the same as the standard

for bare floors.

Specifically, EPA finds that the

following information supports setting a

carpet standard that is the same as the

bare floor standard. First, EPA agrees

with the comments, particularly with

respect to the fact that substantial

amounts of children would remain

unprotected by not having a carpet

standard and that the consequences are

harmful to public health.

With respect to data, EPA has

examined its analysis that supported the

dust-lead hazard standard. That analysis

not only supports the standard for bare

floors, but also the same one for

carpeted floors. This is because the data

that was used as input to its models did

not distinguish between bare floors and

carpeted floors. That is, the Agency’s

risk analysis, its analysis of risk

reduction that could be achieved

through cleanup, and the cost-benefit

analysis for floors evaluated both

carpeted and uncarpeted floors. EPA

cannot definitively state that, in fact, all

factors will be the same for both

carpeted and uncarpeted floors, but

sufficient evidence exists to establish a

carpet standard. This is based upon

considering the potential loophole that

could exist in the absence of a carpet

standard and the fact that some

correlation exists between carpeted and

non-carpeted floors.

The correlation between carpeted and

non-carpeted floors is supported by data

in the rulemaking record, as well as data

submitted by HUD in comment. These

data include the Rochester (NY) Leadin-Dust study and the pre-intervention,

evaluation phase of the HUD LeadBased Paint Hazard Control Grant

(‘‘HUD Grantees’’) Program (data

collected through September 1997), both

of which appear in the record for this

rulemaking and are described in the

Risk Analysis for the proposed rule. The

Rochester Study shows a significant

correlation between dust lead in carpets

and children’s blood lead. Further, the

study showed that the percentage of

children with blood-lead levels above

10 μg/dL were nearly the same with

carpeted and uncarpeted floors (19.8

and 18%, respectively). This correlation

supports setting at least the same

standard for carpeted and non-carpeted

floors. In addition, data from the HUD

Grantees indicate that grantees were

able to reduce dust-lead loadings in

carpets, although the data are limited by

the fact that grantees were working with

higher clearance standards (80 - 200 μg/

ft2 instead of 40 μg/ft2). Nevertheless,

the fact is that the identical cleaning

techniques were used, regardless of the

clearance standard. Finally, there are no

scientific data available demonstrating

that carpeted floors pose different risks

to children than any other type of

flooring.

Accordingly, EPA’s dust-lead, hazard

and clearance standards apply to all

floors. This will ensure that children are

protected from dust hazards on all types

of floors until future rulemakings can

more definitively evaluate the need for

different carpet standards.

iii. Sampling requirements related to

assessing dust-lead hazards. EPA is

adopting the sampling location (63 FR

30342) and interpretation (63 FR

30339—30340) requirements based on

the rationale in the proposed rule. This

regulation amends the work practice

standards for risk assessments at 40 CFR

745.227 to require risk assessors, for

purposes of hazard assessment, to take

samples from floors and interior

window sills. This regulation also

amends the work practice standards to

require risk assessors to make the dustlead hazard determination by comparing

the average of wipe sample results,

weighted by the number of subsamples

in each sample to the hazard standard

for the appropriate surface (i.e., floors,

sills) For multifamily properties, the

risk assessor will determine that

unsampled units of particular type of

surface (i.e., floors, sills) constitute a

hazard if at least one sampled unit is

determined to be a hazard. Unsampled

common areas are presumed to contain

a lead-based hazard if at least one

sampled common area of a similar type

contains a lead-based hazard.

iv. Dust clearance standards. EPA is

explaining in this section its reasoning

for establishing clearance standards for

cleanup of lead dust hazards and work

practice standards for interpreting

composite samples for clearance

purposes.

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 EPA-recognized laboratory

following the cleanup to assure that the

cleanup reduces dust-lead levels to

prescribed ‘‘clearance’’ levels. 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.

With respect to composite sampling,

the work practice standards at 40 CFR

745.227 do not differentiate between

single surface samples and composite

samples for determining compliance

with clearance standards. EPA

recognizes that 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. EPA continues to believe,

however, that composite sampling is a

useful tool for risk assessment and

clearance and wishes to preserve its use

under the regulations, the Agency

proposed a method to remedy this

problem and discussed various related

issues in the preamble to the proposal

(63 FR 30342).

A. Clearance standards for floors and

sills. The final regulation contains

clearance standards for floors and

interior window sills of 40 μg/ft2 and

250 μg/ft2 respectively. This change

from 50 μg/ft2 to 40 μg/ft2 accounts for

the Agency’s decisions to include

standards for carpets as well as bare

floors and to lower the dust lead hazard

standard, as discussed earlier in this

preamble.

The preamble to the proposed rule (63

FR 30341) discusses the statutory

requirements applicable to clearance

standards in TSCA section 402. On the

same page, EPA provides the reasoning

supporting the Agency’s decision to use

the same level to define clearance

standards for dust as is used to define

dust hazard standards for floors and

interior window sills. This section of

the proposal also explains how the

Agency considered available field data

documenting experience with the HUD

cleaning protocol and decided to

propose clearance standards that are the

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1223

same as the dust-lead hazard standard.

These portions of the preamble to the

proposed rule are adopted as support for

the final clearance standards in this

rule.

B. Clearance standard for window

troughs. For window troughs, where

EPA is not issuing a hazard standard,

the Agency has decided to issue a

clearance standard of 400 μg/ft2. This is

a change from the proposal, where EPA

proposed to adopt the then-existing

clearance standard of 800 μg/ft2 from

HUD’s guidance.

The decision is based on EPA’s

consideration of public comments, and

other information available to the

Agency, which suggested that 400 μg/ft2

is an appropriate clearance standard for

window troughs. In the proposal, EPA

used the current HUD clearance level

for troughs (800 μg/ft2). As a result of

the public comments, EPA revisited the

data from the Agency’s clearance

evaluation, which clearly demonstrates

that the 400 μg/ft2 level is achievable

without a major increase in burden. In

six of the eight studies the pass rate for

400 μg/ft2 after one trough clearance test

ranged from 80.3% to 93.6%. The

corresponding range for 800 μg/ft2 is

88.4% to 96.6%. Two of the studies had

significantly lower pass rates at 400 μg/

ft2 (30.6% and 53%). These studies,

however, also had lower significantly

lower pass rates at 800 μg/ft2 (43.5%

and 62.9%).

C. Sampling location and

interpretation of composite dust

samples. EPA is adopting the

amendments to the sampling location

requirements in the abatement work

practice standards at 40 CFR 745.227

discussed in the proposed rule. This

amendment changes sampling locations

from uncarpeted floors and windows to

all floors, interior window sills, and

window troughs. This change is needed

because the EPA is establishing

clearance standards for all floors,

including carpeted floors, and specific

window surfaces.

To remedy the problem that

composite samples may mask the

presence of lead levels that exceed

clearance standards, EPA proposed to

require a risk assessor to divide the

clearance standard by the number of

subsamples in the composite. For

example, if a composite floor sample of

50 μg/ft2 contained four subsamples, the

risk assessor would compare the loading

from the composite sample to 12.5 μg/

ft2 (i.e., the proposed floor clearance

standard divided by four). Using this

approach, it was mathematically

impossible for the composite to pass

when any single subsample exceeds the

50 μg/ft2 proposed clearance standard

for floors. It would have, however,

introduced 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 would not have been

necessary. At the time of the proposal

EPA decided that this method would

provide the best balance of safety,

effectiveness, and reliability (63 FR

30342). EPA specifically asked for

comment on this approach.

Commenters objected to this approach

for several reasons. The most persuasive

is that this approach would create a

significant disincentive for risk

assessors to use composite testing. HUD

specifically referred to a study by Scott

Clark and Paul Succop which showed

that a better approach would be to

compare the composite sample to the

clearance levels divided by half the

number of subsamples. Clark’s and

Succop’s data shows that this approach

produces an equivalent rate of passing

clearance as single surface sampling.

Upon review of this study, EPA has

decided to adopt this approach and is

amending the work practice standards at

40 CFR 745.227 accordingly. Although

the Agency prefers single surface

sampling, it does not want to create a

disincentive to conduct composite

testing since in some circumstances it

can save time and money. By selecting

an approach that judges composite

samples and single surface samples in

an equivalent manner, EPA is removing

the disincentive that the proposed

approach would have created.

b. Soil. This section of the preamble

presents EPA’s decisions regarding the

soil lead hazard standards. It addresses

the soil-lead hazard standards for

children’s play areas and the remainder

of the yard, and management controls

for soil removed during an abatement:

i. Soil hazard standard. For the final

regulation, EPA has selected 400 ppm in

bare soil as the hazard standard for

children’s play areas and is an average

of 1,200 ppm as the soil-lead hazard

standard for the remainder of the yard.

EPA’s decision is a change from the

proposed standard of 2,000 ppm as a

yard-wide standard.

EPA’s reasoning in support of the

2,000 ppm yard-wide standard is

explained in the preamble to the

proposed rule (63 FR at 30328–30330).

To determine the final soil hazard, EPA

uses the same underlying legal and

policy rationale in the proposal. The

Agency, however, now believes it is

more protective of children and still

consistent with the legal and policy

bases to establish a lower level that

focuses on children’s play areas, as well

as a lower level for the remainder of the

yard.

EPA did not identify new information

that has a significant bearing on the

decisions needed for this rule and

indeed is using the same references

cited in support of the proposed soil

hazard standard, to support this final

decision. Comments on the proposal

that questioned whether the proposed

standard would be adequately

protective of children, however, did

cause the Agency to rethink its

approach in reviewing the results of the

analysis and the assessment of the

available options. During this

reevaluation of the options, EPA

considered all options from 400 ppm to

5,000 ppm and selected the most

protective option that could be

supported by the analysis. This section

presents EPA’s rationale for selecting

400 ppm for children’s play areas and

1,200 ppm for the remainder of the yard

as the hazard standards and for not

choosing the other options. Detailed

responses to comments on all the

options are found in the RTC document.

In order for the public to understand

EPA’s reasoning for the final soil hazard

levels, the Agency believes it is

necessary to review its reasons for not

selecting the lowest and highest levels

under consideration (400 and 5,000

ppm yard-wide averages, respectively),

the reasons for proposing 2, 000 ppm

instead of 1,200 ppm as yard-wide

standards, and the reasons for choosing

1,200 ppm in the nonplay areas as the

final soil hazard standard. This

discussion will also show where the

final analysis is consistent with the

proposal and where divergence from the

proposed reasoning is appropriate.

The proposal explained that, to arrive

at a soil-lead hazard level, EPA sought

to determine, with consideration of the

uncertainty of the scientific evidence

regarding environmental lead levels at

which health effects would result, those

conditions for which the Agency had

sufficient confidence in the likelihood

of harm that abatement seemed

warranted to achieve the associated

level of risk reduction. This is the

method EPA has used to arrive at

standards for both dust and soil. The

Agency has determined that this is an

appropriate way under the statute to

determine whether a dust or soil lead

‘‘would result’’ in adverse human health

effects. EPA has followed a similar

approach in examining the final

decision, although it has reached a

different conclusion with respect to

choosing the levels.

In the proposal, EPA rejected options

for both higher and lower soil lead

levels for a number of reasons. While, at

1224 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

the time the Agency was only

considering a yard-wide standard, those

reasons are still relevant to today’s final

decision. However, the Agency’s

reasons for not selecting the extremes of

either 400 ppm and 5,000 ppm, as a

yard-wide standard, were of a more

serious nature than its reasons for not

choosing of 1,200 ppm. For this final

rule, EPA reaffirms the reasoning in the

proposal for not selecting the 400 ppm

and 5,000 ppm standards, as yard-wide

standards, with additional explanations

noted below.

With respect to not choosing the 400

ppm level as a yard-wide standard, EPA

acknowledged in the preamble to the

proposed rule that the results of the

IEUBK model-based analysis at

relatively low soil-lead concentrations

are dependent upon modeling

assumptions that are sensitive to local

conditions, for example the transport of

outdoor soil into a residence. Although

the IEUBK model predicts substantial

benefits resulting from abatement at

higher soil-lead levels, the absence of

site-specific information at lower soillead levels increases the uncertainty in

the public health protection that should

be expected. Consequently, EPA does

not believe that, as a uniform national

soil-lead standard, a value as low as 400

ppm yard-wide represents a reasonable

public policy choice. Also, much of the

benefit that the IEUBK model-based

cost-benefit analysis predicts is very

sensitive to certain of the data and

assumptions used therein. For example,

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.

Second, EPA’s Empirical-based model

cost-benefit analysis has an even greater

difference with the IEUBK cost-benefit

results with respect to the risk reduction

achievable at soil-lead concentrations as

low as 400 ppm yard wide. Had the

Empirical-based analysis yielded results

more similar to the results of the IEUBK

model-based approach, EPA would have

greater confidence that significant risk

reduction is achievable at soil-lead

concentrations between 400 ppm and

1,200 ppm as yard-wide standards for

most properties.

In addition, EPA considered that, at

lower levels, interim controls would be

of greater help in reducing risks than at

higher levels. While EPA lacks

published studies to estimate the

effectiveness of these controls, it seems

reasonable that interim controls can

interfere with exposure pathways and

reduce risk. Flexibility to use these

measures may aid in taking costeffective measures where appropriate.

EPA, however, was not able at the time

of the proposal, and still is not able, to

quantify the benefits of interim controls.

The Agency notes that HUD, provided

data on interior dust lead measurements

at homes where soil interim controls

had been instituted. These data

included average costs of some interim

control strategies and dust

measurements approximately 2 years

after the controls were implemented.

While these data were not used in the

risk analyses that support this rule, they

were examined in sensitivity analyses

that are contained in the Economic

Analysis for today’s rule (Ref. 14).

An additional reason that supports

not using 400 ppm as the yard-wide

soil-lead hazard standard is provided by

a number of commenters arguing that

400 ppm should be the hazard standard,

but that abatement should not occur

until 5,000 and interim controls are

more appropriate at 400 ppm. These

comments come from a number of

advocacy groups and State and local

governments who are experienced in

dealing with abatement issues. EPA

disagrees with these comments, for

reasons discussed in more detail later in

this preamble, because the Agency has

decided to base the hazard standards on

the lowest levels at which its technical

analysis shows that across-the-board

abatement on a national level could be

justified. Nevertheless, these comments

by persons experienced in dealing with

control of lead problems, in effect,

provide additional support for the

Agency’s determination that 400 ppm

should not be a yard-wide hazard under

EPA’s methodology for choosing the

hazard standards (i.e., that 400 ppm

should not be an across-the-board

abatement level).

EPA also fears that by calling 400

ppm yard-wide a hazard, property

owners and other decision makers

would undertake abatements as the

automatic response. A value of 400 ppm

is below the level at which EPA believes

that across-the-board yard-wide

abatement and its associated

expenditure of resources are justified

and at that level could divert resources

from potentially riskier sources of lead

exposure--namely deteriorated leadbased paint and dust-lead hazards.

EPA also was concerned that more

stringent standards would not meet the

priority-setting goals the Agency

believes are appropriate for the Title X

program. Of particular concern was the

fact that the Agency estimates that over

12 million homes would exceed a 400

ppm yard-wide standard. 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.

With respect to the not choosing a

level of 5,000 ppm as the hazard

standard, EPA found that while costs

may be lower at that level, the IEUBK

model-based approach shows that net

benefits also decrease by $ 32 billion

when increasing the standard from

2,000 ppm to 5,000 ppm. While the

empirical model-based approach shows

that net benefits are about the same for

both options, the benefits decline by $9

billion when the standard increases

from 2,000 ppm to 5,000 ppm. Thus, the

absolute benefits at 2,000 ppm are

substantially higher.

As discussed in the preamble to the

proposed rule, however, the difference

between 1,200 ppm and 2,000 ppm as

the yard-wide standard was a closer

call. While 2,000 ppm was justified by

both the IEUBK and the Empirical

model based analysis, there still was

concern for substantial risk at 1,200

ppm. At 1,200 ppm in soil, the IEUBK

model estimates a mean blood lead level

in the range of 8 to 11 μg/dL. This range

of mean blood-lead concentrations

corresponds to a range of approximately

30 to 60% exceeding 10 μg/dL and 2 to

10% exceeding 20 μg/dL. In addition,

there is a much smaller difference in

homes affected when comparing the

2,000 ppm and 1,200 ppm standards as

opposed to comparing 2,000 ppm with

400 ppm. At 1,200 ppm, 4.7 million

homes would exceed the standard.

EPA decided to propose 2,000 ppm

for several reasons. Readers are referred

to the preamble to the proposed rule for

details. First, the results of the empirical

model-based normative analysis showed

that net benefits are positive and near

the maximum level at 2,000 ppm. The

IEUBK normative model-based analysis

showed positive and significantly

higher net benefits at concentrations up

to 2,000 ppm than for soil-lead

concentrations above 2,000 ppm.

Because both analyses showed positive

net benefits at 2,000 ppm, EPA was

confident that this level represented a

reasonable public health policy choice.

The second reason EPA gave in the

proposal for choosing 2,000 ppm was

that, outside of its use in the economics

model, the IEUBK model predicts

significant risk to children at that soillead 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%

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1225

equal to or exceeding 10 μg/dL and 9 to

30% exceeding 20 μg/dL. Although this

is greater than empirical data, the

Agency believes that this application of

the IEUBK model supports the

conclusion that a level of 2,000 ppm

would result in adverse effects.

The third reason given in the

proposed preamble to support the 2,000

ppm soil hazard level was that data

from a number of epidemiological

studies show that between 40 and 50%

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% of

children have blood-lead concentrations

equal to or exceeding 20 μg/dL.

However, there are several limitations

associated with the above analysis.

First, the results are based on a single

media analysis, i.e., the estimated

percent of children with elevated bloodlead concentration considered only the

level of lead in soil and did not control

for the contribution of lead from other

media to blood lead level. Second,

studies were conducted over a period of

time between 1979 and 1996 and the

study duration varied from a couple of

months to several years. Third, the

studies were conducted in different

geographical regions. Some of the

studies were performed in the vicinity

of smelters (active or inactive) or in ore

processing communities. Fourth, the

target populations were different among

the studies (i.e., targeting children with

5-20 μg/dL blood-lead concentration,

high-risks neighborhoods, homes with a

lead-poisoned child, children in a

certain age group).

In the proposal, EPA decided not to

use as its preferred option the more

stringent soil-lead hazard standard.

While EPA interpreted the balancing of

costs and benefits under IEUBK modelbased analysis as showing costs would

be at least commensurate with risks at

1,200 ppm, the results of the empirical

model-based approach suggested they

might not be. In addition, some

epidemiological data indicated

substantial risks even at 1,200 ppm.

Because the Agency’s analysis, thus,

showed that at the national level costs

may not be commensurate with risk

reduction at the lower level. EPA

decided to propose the higher level

because it ‘‘was mindful of the impacts

that the costs of soil abatement could

have on individual properties and

communities.’’ (63 FR 30330) This was

notwithstanding the fact that some

epidemiological data indicated

substantial risks even at 1,200 ppm.

Ultimately, therefore, the consideration

of costs and their impacts was the

primary reason why EPA proposed

2,000 ppm as opposed to 1,200 ppm.

At the time of the proposal, the

Agency also expected that measures

undertaken in response to the proposed

soil-lead level of concern in guidance

and dust hazard standards would help

protect children exposed to soil-lead

concentrations at all levels below 2,000

ppm.

EPA received numerous comments on

the proposed standard which provided

a broad range of perspectives but no

clear consensus. Comments that

questioned whether the proposed

standard would be adequately

protective of children did cause the

Agency to rethink its approach in

reviewing the results of the analysis and

the assessment of the available options.

While EPA did not choose the options

at the extremes, the Agency’s principal

dilemma as it considered comments on

the proposed rule was to consider

whether it should retain 2,000 ppm as

the soil hazard standard or move to

1,200 ppm. EPA also received many

comments that it should establish a

separate play area standard. The Agency

has resolved these problems, for the

final rule, by establishing a 400 ppm

standard for children’s play areas and

an average of 1,200 ppm standard in the

remainder of the yard. The following

discussion presents EPA’s rationale for

selecting 400 ppm as a children’s play

area standard and for selecting 1,200

ppm as the hazard standard for the

remainder of the yard and for not

choosing 2,000 ppm.

A. Play area hazard standard. As

explained above, EPA’s proposal was to

establish a single hazard standard that

would be used for the entire yard. Many

comments were received on this

approach that were highly critical of the

Agency for not treating the play area

separately from the rest of the yard.

These commenters reasoned that the

play area is where children receive a

significant proportion of their exposure

to soil and that, therefore, the Agency

should establish a more stringent

standard for play areas. The Agency is

persuaded by these comments and has

reconsidered its treatment of play areas.

The Agency’s initial reluctance to

considering a separate standard for play

areas was the concern that play areas

could not be readily distinguished from

the remainder of the yard. Among the

comments that urged the Agency to

consider a separate standard were

comments from local public health

agencies stating that risk assessors can

readily identify play areas, thus making

EPA’s primary objection to this

approach (feasibility), moot. Given that,

in responding to these comments, the

Agency, consistent with the

interpretation that was stated in its

proposal, focused upon the condition

and location of lead in soil that would

result in adverse health effects. As

opposed to assuming equivalent

exposure from all areas of the yard, the

Agency agrees that it is also appropriate

to consider that the extent of exposure

and the potential for risk reduction is

much greater in play areas.

Consequently, because of the high levels

of exposure that almost by definition

correspond to a ‘‘play area,’’ the Agency

believes it appropriate to consider 400

ppm to be a soil-lead hazard when that

soil is situated in a child’s play area.

The Agency’s next step was to attempt

to estimate how a separate play area

standard would affect the risk reduction

that would result from various other

standards (e.g., 1,200 ppm and 2,000

ppm) in the rest of the yard. The Agency

tried various options to partition

children’s expected exposures from soil

in play areas and soil in the rest of the

yard. This posed numerous problems,

which will be described later in this

section, but it did indicate that an

approach which focuses primarily upon

a child’s play area would likely be

preferable in terms of protectiveness,

risk reduction, and cost-effectiveness.

In its analysis, the Agency considered

two options for the degree of exposure:

(1) That 50% of exposure is from play

area soil and 50% is from soil in the rest

of the yard; and (2) that 2/3 of the

exposure is from play area soil and 1/

3 is from soil in the rest of the yard. The

Agency coupled these exposure

assumptions with two assumptions

regarding the relative size of the play

area: (1) That 10% of the yard is the

play area (‘‘small yard’’); and (2) that

50% of the yard is the play area. These

analyses indicated that, in situations

where the play area is small, an

approach which establishes a more

stringent standard for the play area can

be more optimal in terms of cost

effectiveness (and obviously more

protective) than a less stringent standard

applied to the yard as a whole.

For example, in the ‘‘small yard’’ case

where exposure is assumed to be 50%

from the play area and 50% from the

rest of the yard, the consequences of

moving from a yard-wide average

standard of 1,200 ppm to standards of

400 ppm for the play area and 1,200

ppm for the rest of the yard are as

follows: total costs are increased slightly

from $68.9 to $70.4 million while total

benefits increase from $159.3 to $174.2

million, using the IEUBK model. This

results in an increase in net benefits

from $90.4 to $103.8 million. Using the

Empirical model, this analysis produces

1226 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

the same trend, although the results are

less dramatic, indicating an increase in

net benefits of $1.4 million. The results

of these analyses confirm that the

establishment of a separate, more

stringent standard for play areas can

constitute a more targeted, more

protective, and more cost-effective

approach, especially where play areas

are not large.

As noted above, while the Agency

believes that these analyses are

indicative of the benefits of separate

standards for the play area and the rest

of the yard, there are a number of

technical problems associated with such

analyses. First, the amount of direct

exposure to soil that children

experience in their play areas versus the

rest of their yard has not been studied

to any significant degree. A further

complication is the fact that there is

little or no data on the actual, or even

relative, sizes of play areas.

Additionally, the soil in the rest of the

yard can re-contaminate play areas

where interventions have previously

occurred. For these reasons, the Agency

was unable to develop definitive

estimates of risk and available risk

reduction for separate standards for the

play area and the rest of a yard.

The Agency believes that these

analyses serve to demonstrate that, to

the extent to which children’s exposure

to soil is greater in a play area and the

size of the play area is smaller compared

to the rest of a yard, greater risk

reduction (and at a lower cost) would be

achieved with a separate standard for a

play area and a different standard for

the rest of the yard (as opposed to

applying a single standard to the entire

yard). Consequently, the Agency

believes that establishment of a more

stringent standard for the play area will

be more cost-effective as well as more

protective of children.

B. Remainder of yard hazard

standard. EPA believes that, based on

the technical analysis, either an average

of 1,200 ppm or 2,000 ppm level could

be chosen under the applicable statutory

criteria that the conditions of leadcontaminated soil would result in

adverse health effects. EPA chose 1,200

ppm for the final rule because it is the

most protective level at which EPA has

confidence that the risks warrant

abatement.

EPA’s most basic reason for choosing

1,200 ppm over 2,000 ppm is that the

IEUBK model estimates that an

individual child would have a 30 to

60% risk of having a blood lead level

equaling or exceeding 10 μg/dL, and

that some epidemiological data

indicated substantial risk at 1,200 ppm.

EPA recognizes that this is an

overestimate because it was derived

without consideration of a play area.

EPA recognizes that with separate

consideration of a play area, the overall

individual risks will likely be lower. It

is also important to note that the

epidemiological data referred to as

indicating substantial risk at 1,200 ppm

is the same data, and subject to these

same caveats as are discussed in the soil

hazard standard section. Also, the

Agency notes that abatement at levels

above 1,200 ppm have been shown to

result in declines in childrens’ bloodlead levels. For example, in evaluating

the Boston portion of the Urban Soil

Lead Abatement Demonstration Project

(Ref. 17), the Agency found that:

... the abatement of soil in the Boston study

resulted in a measurable, statistically

significant decline in blood lead

concentrations in children, and this decline

continued for at least two years. It appears

that the following conditions were present,

and perhaps necessary for this effect: (a) a

notably elevated starting soil lead

concentration (e.g., in excess of 1,000 to

2,000 ug/g (ppm)); (a marked reduction of

more than 1,100 ug/g in soil lead consequent

to soil abatement accompanied by (c) a

parallel marked and persisting decrease in

house dust lead.

None of these factors, alone, would

lead to choosing 1,200 ppm. When

combined with the range of uncertainty

in either of the cost-benefit analyses,

however, the support of the IEUBK costbenefit analysis, and the nearness to the

empirical-based model analysis that

would support the 2,000 ppm standard,

these factors tip the balance towards the

lower of the two levels.

EPA finds national data are not

inconsistent with the IEUBK individual

risk analysis. EPA estimates, based on

the HUD National Survey Data that 4.7

million homes have soil-lead levels that

exceed 1,200 ppm. Of these 4.7 million

homes, an estimated 830,000 would be

occupied by children under the age of

6 (based on the estimate from the 1993

American Housing Survey that 17.6% of

homes are occupied by children under

the age of 6). According to the IEUBK

prediction, elevated blood lead levels

due to lead in soil exceeding 1,200 ppm

could be found in 30% of these children

(based on the lower end of the IEUBK

predicted individual range, without

consideration of the play area standard),

about 250,000 children. Since over

900,000 children, nationwide, have

elevated blood-lead levels EPA finds it

credible that soil-lead could be a factor

in these childrens’s blood levels.

EPA decided not to select its

proposed choice for the soil-lead hazard

standard, 2,000 ppm, for several

reasons. First, the Agency’s analysis

shows that there is substantial and

credible risk at soil-lead concentrations

below this level. Second, significant risk

reduction is possible below this level.

In making its decision, EPA was

mindful of the concerns associated with

lowering the soil standard from 2,000

ppm to 1,200 ppm. By picking a more

stringent hazard standard, EPA

increases the estimated number of

homes that are potentially affected by

2.2 million. Abatement costs may also

divert resources from efforts to control

exposure from deteriorated paint and

dust which are possibly more significant

sources of exposure.

Nevertheless, experience with interim

control programs is increasing and

certain organizations, particularly

public health and housing agencies,

believe they have been able to develop

effective programs for interim controls

which achieve virtually the same degree

of risk reduction as do abatement

programs, but at much reduced cost.

EPA received comments on this issue

during the public comment process.

EPA wishes to encourage the continuing

evaluation of such efforts because

resources to deal with hazardous lead

levels may be very limited, and

strategies which achieve comparable

risk reduction, but at much reduced

cost, have the potential to protect more

children by allocating the limited

resources more effectively. Recognizing

that a site-specific evaluation may

identify unacceptable risks to children,

it may be necessary to take a more

rigorous approach to mitigate those risks

as the lead-levels increase. EPA believes

that public and private organizations

should evaluate both interim control

and abatement strategies in determining

the most effective course of action when

dealing with dust and soil hazards.

C. De minimis area of bare soil. In the

proposal, EPA considered whether the

rule should include a minimum (i.e., de

minimis) area of bare soil as part of the

lead hazard criteria. 63 FR 30337-8. The

Agency rejected inclusion of a de

minimis area of bare soil for the hazard

standard, but did request comment on

two other options. Under one of the

other options, EPA would adopt the de

minimis area from the HUD Guidelines,

which instruct risk assessors to sample

yards that have at least 9 square feet of

bare soil, with no de minimis in the play

area. HUD’s final rule under section

1012/1013 of Title X incorporates this

into its interim soil lead hazard

standard. That is, a hazard does not

exist where there are less than 9 square

feet of bare soil outside the play area.

EPA still rejects including a de

minimis area of bare soil for the hazard

standard for the same reasons stated in

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1227

the proposal. EPA’s reasoning is that the

disadvantages of establishing a de

minimis outweighed the advantages.

EPA has no analysis or data that relate

the amount of bare soil to risk. 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.

Second, the incremental cost of

including soil testing in a risk

assessment is small. Moreover, the de

minimis used in the HUD Guidelines

does not account for differences in yard

size. Outside of the play area, 9 square

feet may be insignificant in a suburban

yard but large for the back yard of an

urban row house.

However, EPA highly recommends

using the HUD Guidelines for risk

assessment (Ref. 5). This would avoid

declaring very small amounts of soil to

be a hazard in the non-play areas of the

yard. This would also 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.

D. Management of removed soil. EPA

is adopting the proposed requirement

for management of soil removed during

an abatement (63 FR 30343). This

requirement prohibits the use of soil

removed during abatement as topsoil in

another residential property or childoccupied facility. In response to

comment, EPA would like to clarify that

applicable Federal and State

requirements apply to removed soil

including testing pursuant to RCRA

under the Toxicity Characteristic

Leaching Procedure and disposal of soil

identified as hazardous waste (Ref. ?).

The Agency also advises that care

should always be taken to ensure that

removed soil does not pose immediate

or future risks to human health. For

example, it should not be disposed of at

an undeveloped site that may later be

developed as residential or converted

into a playground.

c. Paint. This section of the preamble

presents EPA’s decisions regarding the

standards for hazardous lead-based

paint. It addresses the deteriorated

paint, paint on friction and impact

surfaces, and surfaces accessible for

chewing or mouthing by young

children. This section also discusses

relevant amendments to sampling

requirements.

i. Deteriorated paint. The final

regulation adopts the Agency’s

underlying rationale in the preamble to

the proposed rule for setting the hazard

standard for deteriorated paint.

Specifically, EPA reaffirms its argument

in the preamble to the proposed rule (63

FR at 30330–30331) that the available

evidence demonstrates a relationship

between deteriorated lead-based paint

and blood-lead. Due to the continuing

lack of data, however, EPA is still

unable to definitively select an area

threshold below which the lead-based

paint would not be a hazard. Further,

EPA has received substantial public

comments that even very tiny amounts

of deteriorated paint can cause harm

and should be addressed. As a result,

the Agency has reevaluated its

rulemaking record and no longer

believes it is appropriate to have a

threshold level of deteriorated leadbased paint below which a paint-lead

hazard does not exist.

Accordingly, EPA has decided to

identify as the paint-lead hazard any

deteriorated lead-based paint, except in

the case of friction surfaces. For friction

surfaces, as noted below, a paint-lead

hazard may exist if the surface is subject

to abrasion and dust lead levels on the

nearest horizontal surface underneath

the friction surface are equal to or

greater than the dust hazard levels.

Furthermore, EPA has decided that it

was not appropriate to refer to any area

threshold for deteriorated lead-based

paint as a de minimis threshold. Using

this terminology gives the public the

perception that the Agency believes

risks at lower levels of deterioration are

inconsequential and that no action

should be taken.

While establishing this paint-lead

hazard standard would alert the public

to the fact that all deteriorated paint

needs to be addressed, EPA

acknowledges that paint stabilization or

interim controls (activities less than

abatement) would often be appropriate

to address paint, particularly at lower

levels of deterioration or where the

deterioration is minor, such as less than:

Two square feet of deteriorated leadbased paint per room; 20 square feet of

deteriorated exterior lead-based paint;

or 10% or less of deteriorated paint on

the total surface area of an interior or

exterior type of component with small

surface area. EPA, further, emphasizes

that applicable HUD and EPA

regulations do have area threshold

exemptions for various work practice

standards, clearance, and certification

requirements.

A. Comparison of proposed and final

rules. EPA proposed to adopt as the

paint hazard threshold levels those

levels identified in the 1995 HUD

Guidelines that defined paint in poor

condition. These levels were

‘‘component based.’’ That is, there were

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

ten square feet of deteriorated leadbased paint on any large exterior

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

deteriorated lead-based paint on more

than 10% of the surface area of any

small architectural component (such as

window sills and baseboards). Under

HUD’s Guidelines no action was

required for paint with lesser amounts

of deterioration.

The Agency proposed using the

criteria in the HUD Guidelines because

they were becoming the de facto

industry standard that was being

considered for incorporation into model

housing and building codes and by State

officials for adoption as State standards.

In addition, 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. EPA also noted that with an area

threshold level in place, millions of

homes would not be identified as

having hazardous paint and that this

would reduce the number of paint

abatements while still providing

protection to the populations of

concern. Nevertheless, the preamble to

the proposal emphasized 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 received numerous comments on

the issue of the area threshold.

Comments varied from those that argued

that all lead-based paint, regardless of

condition, should be a hazard to those

that argued the Agency should have no

separate paint standard but should rely

on the dust and soil standards.

Comments in between recommended

such standards as all deteriorated paint

should be a hazard, or that the area

thresholds should be lower or more

clearly explained. As a result of

considering the comments and all other

information available in the rulemaking

record, EPA is issuing a final rule that

generally provides that any deteriorated

lead-based paint would be identified as

a hazard. Below, EPA explains its final

decision. Detailed responses to all

significant comments are found in the

RTC document.

While there were no comments that

could directly quantify the relationship

between deteriorated paint and blood

lead levels, two comments attempted a

1228 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

very rough quantification that EPA can

use for limited support for its

determination that any deteriorated

lead-based paint is a paint-lead hazard.

One comment cited an analysis by the

Consumer Product Safety Commission

(CPSC) suggesting that very small areas

of deteriorated lead-based paint could

present hazard to young children.

According to this analysis, chronic

ingestion of lead from paint and other

consumer products should not exceed

15 ug/day to prevent a young child from

having a blood lead levels that exceeds

10 μg/dL. Assuming a 30% absorption

rate and and paint with 0.5% lead by

weight, this analysis estimates that a

child would have to ingest as little as 6

square inches of paint over a month to

have an elevated blood lead level.

Another comment submitted a

theoretical calculation that the proposed

standard for the dust lead hazard of 50

μg/ft2 would be exceeded if only one

square centimeter of lead-based paint

with a concentration of 4 mg/cm2 were

ground into dust and evenly distributed

in an eight by ten foot room. Other

commenters presented anecdotal

evidence that children have been leadpoisoned as a result of exposure to very

small quantities of lead-based paint.

In addition, EPA has also considered

the fact that HUD’s standards, upon

which EPA relied as a consensus

standard, have changed with the

issuance of HUD’s final regulations

under sections 1012/1013 of Title X.

EPA believes it is appropriate to

conform its final paint-lead hazard

definition to HUD’s regulations. It is

EPA’s determination that HUD is the

government agency with the most

experience in dealing with residential

paint and the Agency has chosen to rely

on HUD’s judgment in these matters as

to amounts of deteriorated paint that

would result in adverse health effects.

Industry standards tend to follow the

leadership of HUD guidelines and

regulations. EPA’s consideration of the

issues involving the uncertainty of

choosing a paint hazard area threshold

under the statutory standard for

determining what constitutes a hazard,

as well as a discussion of the history of

the HUD standard for hazardous paint

and EPA’s evaluation of HUD’s

regulations follow.

B. Uncertainty analysis. Any

deteriorated paint could conceivably

cause adverse health effects, as noted by

several comments. Furthermore, EPA

would want people to know that any

deteriorated paint needs to be dealt

with. Very small amounts of leadcontaminated paint could be a cause for

concern. Even a few paint chips could

provide a very concentrated dose to a

child that may ingest them. They may

prove to be an attractive nuisance

(particularly if they are brightly colored)

that might encourage a child to ingest

them. Any deteriorated surface could

rapidly expand, particularly if a child

should decide to pick at it. Because of

this concern any deteriorated paint

should be carefully monitored and

stabilized.

The Agency cautions, however, that it

does not believe full scale abatement,

with all attendant regulations, would be

appropriate for all deteriorated leadbased paint, particularly at the lesser

areas of deterioration (i.e., less than: 2

square feet of deteriorated lead-based

paint per room; 20 square feet of

deteriorated exterior lead-based paint;

or 10% or less of deteriorated paint on

the total surface area of an interior or

exterior type of component with small

surface area).

Abatement in cases where there are

very small amounts of deteriorated paint

would make no sense in view of the fact

that approximately 60 million

residences have some lead-based paint

and approximately 13.5 million have

some deterioration. The National Survey

of Lead and Allergens results will be

released in the near future with a

different estimate from that on which

these numbers were based (Ref. ?).

Recommending abatement for all

hazards when relatively few children

seem to be affected when compared to

the total amount of homes with

deteriorated paint could result in the

cleanup of millions of homes that would

result in little to no reduction in risk.

Therefore, EPA believes that minimal

degradation does not warrant

abatement.

Nevertheless, the Agency leans

towards being more protective in the

face of uncertainties and has decided to

have a standard at which any amounts

of deteriorated paint would be

considered a lead-based paint hazard.

The more cracked or deteriorated paint

that exists in a residence, the more

likely it would be that amount of

degraded paint would increase. The

greater the deterioration, the more likely

the increase in lead in dust. The paintlead hazard levels would enable people

to take protective action before

excessive exposure to dust would occur.

Since people are not likely to constantly

monitor for dust levels, providing a

standard that would focus on paint

deterioration is an added level of

protection. In addition, the more

cracking and deteriorated paint that

exists, the more likely the lead would be

available for potential exposures

through ingestion via dust or direct

ingestion of paint chips.

In addition, EPA has decided to use

the HUD interim standard for the paintlead hazard (Ref. 5). This is because, in

addition to the reasons stated above for

having no threshold area, , the HUD

standard is a level that people

responsible for addressing the paintlead hazards are either familiar with

now or will have to become familiar

with and, in the absence of any other

definitive level, to choose, it makes

sense to use the same standard as a

sister agency for ease of identification

and compliance. Of course, EPA will

reconsider its decision should any

information become available to allow

choosing a more definitive level.

C. HUD’s standard. EPA concurs with

HUD’s reasoning for setting its interim

paint-lead hazards, as discussed in this

section. HUD’s reasoning for eliminating

a level below which no action is

required is explained in the preamble to

HUD’s final 1012/1013 rule. HUD stated

that it was convinced by various

comments from the public that there

should not be an area threshold of

deteriorated paint below which no

action is required. These comments

were: (1) That the de minimis exception

(as it was referred to at the time) is

arbitrary and not supported by science;

(2) that the levels are too large,

potentially allowing a total of over ten

square feet of defective paint per room

(counting four walls plus a ceiling plus

small components); (3) that some

owners or inspectors may use the area

threshold as an excuse for overlooking

hazardous conditions; and (4) that it is

likely to shift the attention of workers

from the importance of practicing lead

hazard control and maintaining painted

surfaces in a lead-safe manner to

measuring the size of defective paint

surfaces in order to document that

surfaces fall above or below the de

minimis level. (See 64 FR 50156.) In

addition, HUD received comments that

persons dealing with the threshold

levels found it difficult to understand

and put in practice. These comments

indicated that people would spend too

much time measuring the exact areas of

deteriorated paint instead of focusing on

making housing lead safe. (See 64 FR

50198.)

Based on these comments, HUD’s

final rule eliminates any provision that

provides no action is needed with

regard to deteriorated paint. HUD

concluded this based on experience in

its tenant-based assistance programs

(where the area threshold provision was

made effective in 1995) that indicated

that the area threshold was a cause of

confusion. (See 64 FR 50198.) As a

result, HUD’s final rule provides that all

deteriorated lead-based paint (either

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1229

known or presumed to be lead-based

paint) must be addressed. According to

HUD, this would simplify the rule’s

implementation considerably.

Even though, under HUD’s regulation

all deteriorated paint must be

addressed--through use of paint

stabilization or interim controls, HUD

nevertheless acknowledges that

something less than abatement and,

consequently, fully certified personnel,

would be needed to address paint at

lower levels of deterioration. HUD, thus,

retained an area threshold exemption

for required work practice and clearance

standards. The levels of deterioration in

this standard are the same as provided

in EPA’s TSCA section 402 work

practice regulations--2 square feet of

deteriorated lead-based paint per room,

20 square feet of paint on the exterior

building, or 10% of the total surface

area on an interior or exterior type of

component with a small surface area.

EPA’s work practice standards were

promulgated on August 26, 1996, 61 FR

45778. These standards have become

the industry standard, having been in

place since then and having been

acknowledged as enforceable standards

followed by the public. Thus, under

HUD’s regulations, activities that

disturb painted surfaces of lesser

deterioration do not have to use

certified workers, work practices

required under regulation, or work site

clearance. (See 64 FR at 50149, 50156,

50166, 50184, 50185, and 50198.)

HUD had also submitted comments

on this proposed 403 rule

approximately 1 year before its 1012/

1013 rule was issued. These comments

were consistent with HUD’s eventual

final 1012/1013 rule in the sense that

they explained that HUD has found it is

more practical to require deteriorated

lead-based paint of any size surface area

to be addressed. HUD commented that

use of an area threshold criterion for

determining whether any control is

necessary has the effect of having

inspectors or risk assessors making

efforts to measure surface areas instead

of focusing on control of deteriorated

paint. Further, it had been HUD’s

experience that some lead-based paint

hazards have not been repaired because

of confusion on whether or not enough

of the paint had deteriorated to warrant

attention.

HUD recommended that EPA should

eliminate the area threshold for

eliminating any need to control

deteriorated paint. However, HUD then

stated, ‘‘All deteriorated paint of any

size should be considered a hazard and

should be repaired; however,

containment, clearance, and safe work

practices need not be required for

hazards’’ below the area threshold.

D. EPA’s decision. For the reasons

discussed above, EPA identifies as a

paint-lead hazard any deteriorated leadbased paint, for surfaces other than

friction surfaces, as noted below.

However, EPA notes a caution that there

is a level above which serious

restrictions should be placed on worker

certification and work practice

standards and below which such

restrictions are not needed. HUD and

EPA also agree that any deteriorated

paint needs to be dealt with.

Additionally, to attain consistency

with the requirements of the 1012/1013

rule in the sense that action less than

abatement should be taken with respect

to levels below the hazard threshold,

EPA is modifying the work practice

standards found at 40 CFR 745.227 to

require risk assessors to test all

deteriorated paint on surfaces with a

distinct painting history. This

requirement would provide owners and

other decision makers with information

that would help these individuals take

appropriate action (e.g., stabilize small

amounts of deteriorated paint, increase

monitoring of the property and resident

children). Currently, the work practice

standards require risk assessors to test

paint only where deterioration exceeds

the area thresholds. This sampling

requirement, as amended, also applies

to accessible surfaces. The existing

sampling requirements do not

separately address paint testing on these

surfaces. The sampling requirements for

friction and impact surfaces are

discussed below.

ii. Friction and impact surfaces. In the

final rule, a paint-lead hazard exists on

a friction surface that is subject to

abrasion and where the lead dust levels

on the nearest horizontal surface

underneath the friction surface are equal

to or greater than the dust hazard

standard for that surface. A paint-lead

hazard exists on an impact surface when

there is any damaged or otherwise

deteriorated paint that is cause by

impact from a related building

component such as a door knob that

knocks into a wall or a door than knocks

against its door frame.

EPA did not include a preferred

option for friction/impact surfaces in

the proposed regulation, but instead

asked for comment on several options

(63 FR at 30332–30333). These options

included: Any lead-based paint on a

friction/impact surface, abraded paint

on a friction/impact surface, or no

separate standard. In the latter case, the

deterioration of paint on friction/impact

surfaces would be counted along with

the deterioration of all paint to

determine hazardous paint, or the dustlead hazard standard could be relied

upon.

The final paint-lead hazards for

friction and impact surfaces are within

the range of options discussed for the

proposal. EPA decided to include a

reference to abrasion as a condition of

hazard on the friction surfaces because

abrasion indicates that the rubbing or

impact of the surfaces is likely to

generate lead-containing dust. To this

condition the Agency added the

presence of dust at the dust-lead hazard

level because the combination of

deterioration with rubbing or impact is

likely to generate lead-contaminated

dust. In light of the limited data

available to EPA, the Agency issued a

standard based on a reasoned and

common sense approach that identifies

conditions likely to contribute lead to

dust and the existence of dust at the

hazard level. Even with the condition of

deterioration added, this option falls

within the bounds of the alternatives

presented in the proposal. It is more

stringent than the alternative based on

abrasion alone but less stringent than

the option that would identify any leadbased paint on a friction and impact

surface as a hazard.

In promulgating the friction surface

paint-lead hazard standard, EPA has

considered those comments that urged

the Agency not to establish a separate

standard for friction and impact

surfaces, but instead to focus on dust.

On friction surfaces, the absence of

either a component that is not subject to

abrasion or dust-lead at the hazard level

would eliminate the component as a

paint-lead hazard. This is because a

positive dust test (i.e., presence of a

hazard) suggests that a friction surface is

a source of lead contamination.

EPA also determined that identifying

as a hazard lead-based paint on friction

and impact surfaces regardless of the

paint’s condition is inappropriate. The

Agency does not believe that intact

paint can generate significant amounts

of lead-containing dust. Commenters

who favored Option 1 failed to provide

evidence supporting the contention that

these surfaces contribute to leadcontaining dust regardless of the paint’s

condition. The strongest argument

presented by a proponent of Option 1

stated that the hazard designation

would lead to the testing of these

surfaces for the presence of lead-based

paint. Property owners and occupants

would then, at a minimum, be

encouraged to monitor the condition of

the paint and keep it intact. Monitoring

of paint condition, however, does not

require knowledge that the paint is leadbased. EPA believes that owners/

1230 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

managers/occupants of target housing

should monitor the condition of any

paint on friction and impact surfaces. If

the paint deteriorates or becomes

abraded at any point and young

children occupy the residence, the paint

should be tested to determine if the

paint is lead-based and if a hazard

exists. Furthermore, if the component

has any abraded or deteriorated paint, it

would have to be tested as part of a risk

assessment.

The final regulatory decision has also

led EPA to amend the sampling

requirements for lead-based paint under

the work practice standards for risk

assessments at 40 CFR 745.227. This

amendment will require risk assessors

to sample any visibly abraded or

deteriorated paint on friction and

impact surfaces as part of a risk

assessment.

iii. Accessible (chewable) surfaces.

The final rule at § 745.65(a) uses the

term ‘‘chewable’’ surface to refer to the

statutory term ‘‘accessible’’ surface. A

paint-lead hazard exists on any

chewable lead-based paint surface on

which there is evidence of teeth marks.

EPA did not include a preferred option

for accessible/chewable surfaces in the

proposed regulation, but instead asked

for comment on several options (63 FR

30333). These options included: Any

lead-based paint on a interior window

sill up to 5 feet off the floor; and no

separate standard.

EPA decided to include a standard for

chewable surfaces in the final rule,

which is more stringent than no

separate option and less stringent than

any lead-based paint on interior

window sills, for the following reasons.

EPA has added evidence of chewing as

a factor for determining whether a paintlead hazard exists and has eliminated

any requirement that the chewable

surface must be up to 5 feet from the

floor. The data available to the Agency

indicate that chewing on protruding

components is extremely rare, it

nevertheless presents a cause for

concern. Accordingly, evidence that

chewing occurs would enable the public

to focus attention on those areas where

the risk is real. Further, by adding this

evidence of chewing requirement, there

would be no reason to retain any height

requirement for the chewable surface. If

there is evidence of chewing on a leadbased paint surface, there need be no

other factor to consider.

The option that would identify leadbased paint on interior window sills

regardless of paint condition as a hazard

is not likely to protect any significantly

larger amount of children than would be

protected by the requirement to have

evidence of chewing. On the other hand,

such a stringent requirement could lead

to action in millions of other properties

where children do not exhibit this

behavior, diverting resources from more

significant sources of exposure such as

deteriorated paint and lead-containing

dust.

Most proponents of this option or

options to include a broader range of

surfaces failed to provide a compelling

basis to EPA for selecting this or broader

options because they did not provide

supporting data (and most did not

provide analysis). One State health

department suggested that this option

would lead to paint testing of these

surfaces. Property owners and

occupants would then, at a minimum,

be encouraged to monitor conditions.

EPA recognizes that it would be useful

to know if chewable surfaces are

covered with lead-based paint so that

these surfaces and the chewing behavior

of resident children can be monitored

by owners and occupants. Chewing

behavior by young children, however,

can and should be monitored in the

absence of this knowledge. This

approach would avoid widespread

testing of intact paint, which is costly

and may require damaging the paint in

situations where an x-ray flourescence

(XRF) instrument cannot be used.

Several other commenters noted the

data that EPA presented relates to

chewing, not mouthing of surfaces.

Although mouthing may be more

frequent than chewing, exposure is less

likely to result from mouthing of intact

surfaces. If the paint on interior window

sills is intact, it would likely have been

repainted since lead-based paint was

banned for residential use over 20 years

ago. Consequently, a child who mouths

intact paint would likely come in direct

contact only with paint that is not leadbased and meets the Consumer Product

Safety Commission standard for new

residential paint (i.e., 0.06% by weight).

It is important to emphasize that EPA

does not intend to imply that mouthing

of intact painted surfaces is risk-free

behavior. Mouthing of intact paint may

result in exposure to low levels of lead

and other chemicals and, therefore,

should be avoided.

The Agency wishes to note that it is

very concerned about the potential

exposure for the relatively few children

who do chew on intact lead-based paint

on such surfaces. The Agency has

concluded that the best way to protect

these children who do chew on such

surfaces is through guidance that

strongly recommends immediate action

when such behavior is observed. A

range of responses is available to

property owners and other decision

makers, such as plastic or metal

coverings.

iv. Requirements for interpreting

paint sampling. EPA is adopting the

proposed requirements for interpreting

paint sampling results (63 FR 30339)

except for one clarification that is being

made in response to a comment from

HUD. The Department stated that

language regarding the assumption risk

assessors should make about paint on

surfaces that have not been tested was

unclear. The proposed requirement

stated that the risk assessor is to

‘‘assume all like surfaces that have a

similar painting history contain leadbased paint if the tested component has

lead-based paint.’’ HUD asserts that the

term ‘‘like surface’’ is ambiguous as to

whether it refers to building

components in the same room

equivalent or anywhere in the building.

Chapter 7 of the HUD Guidelines

indicates that this extrapolation can be

made only to components in the same

room equivalent, with extrapolation to

untested room equivalents appropriate

only in restricted circumstances. HUD,

therefore, recommends that the method

be amended to read ‘‘assume all like

surfaces in the same room equivalent

that have a similar painting history . .

.’’ EPA agrees with HUD that the term

‘‘like surfaces’’ is ambiguous and has

changed the language to read ‘‘like

surfaces in the same room equivalent.’’

The requirements for interpreting the

results of paint testing apply to friction

and impact surfaces, chewable surfaces,

and other surfaces with deteriorated

paint. EPA is also adopting the

provision that allows risk assessors to

use composite paint sampling. The

Agency wishes to restate the point made

in the proposal (63 FR 30339), however,

that composite sampling for paint can

be used to rule out the presence of lead

based paint but cannot be used to

identify the specific sample (and

therefore component) that is lead-based.

Therefore, a risk assessor should only

use composite testing if he or she is

reasonably confident that lead-based

paint is not present on the surfaces

sampled.

4. Certified risk assessor requirement.

In the proposed rule, EPA included a

requirement that lead-based paint

hazards be identified by certified risk

assessors following the risk assessment

work practice standards and that ex situ

sample analysis be performed by

recognized laboratories. The Agency

argued that this approach would ensure

the reliability of sampling results and

provide flexibility for future changes in

hazard evaluation technology.

This issue received substantial public

comment and raised concerns which

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1231

have led the Agency to reconsider

promulgation of this requirement. Many

commenters believed that such a

requirement would inhibit the ability of

communities and individuals to identify

lead-based hazards, and to deliver

services or pursue response actions to

protect children when an obvious

hazard is present, due to the cost of full

risk assessments and the lack of

availability of risk assessors. Other

commenters questioned the Agency’s

authority to mandate such a restriction.

Some commenters believed that

certification was appropriate and

necessary to ensure the quality and

reliability of hazard determinations, but

questioned the need for full risk

assessments or for such lead-based paint

activities to be restricted to risk

assessors. Some commenters also

suggested that a screening procedure be

allowed in lieu of a full risk assessment.

In reconsidering its proposed

requirement, the agency agrees with the

comments that current shortages and

surpluses both in availability of risk

assessors, and potentially high costs for

full risk assessments could, in certain

localities, impede response actions for

at-risk children. It also recognizes that

for certain hazard determinations, such

as the visual determination of

deteriorated paint, or analysis of dust

levels, a full risk assessment may not be

appropriate and may waste scarce

resources available for hazard control or

abatement.

The Agency also recognizes that a

certified risk assessor may not be

necessary for the simple visual

determination of deteriorated paint, and

that such more elementary evaluations

of hazards at a property could

potentially be performed by individuals

with less training and experience than

a certified risk assessor, and that such

limited activities may not in themselves

require certification, but may be

performed effectively and reliably when

the person performing those activities

does so under the supervision of a

certified risk assessor or other certified

lead professional. In addition, the

Agency did not intend to require that

certified risk assessors be required to

perform clearance sampling following

abatements. For these reasons, the

Agency believes it prudent to deal with

these general issues in subsequent

rulemakings and regulatory

interpretations which will further

address work practices and

/certification requirements for both.

While the Agency believes that these

issues are best addressed in the overall

framework of the section 402 work

practices and certification standards, it

is nevertheless concerned that those

uncertified individuals who may seek to

determine hazards may not always

produce results of the same quality and

reliability as those obtained by a

certified risk assessor, and that the use

of uncertified personnel to determine

the presence or absence of lead-based

paint hazards should be considered

with caution.

Sampling of dust and soil to

determine lead-based paint hazards is

not a trivial procedure. The procedures

which must be followed by risk

assessors in determining the nature and

extent of lead-based paint hazards at a

property are stated at 40 CFR 745.227.

If uncertified individuals are used to

determine hazards, it is critical that they

have the appropriate training, and

follow appropriate procedures for

sampling, custody of samples, and

analysis of samples to obtain defensible

results. If uncertified persons lack the

training and experience to determine

lead-based paint hazards properly, their

findings may result in detrimental

consequences to the health of children

and create false liabilities for property

owners. A false negative result--the

failure to determine the presence of a

hazard when one actually exists, will

fail to protect children from real

hazards. A false positive result--the

determination of a hazard when none is

present--may cause an owner to spend

additional resources to hire a certified

risk assessor.

IV. Overview of Significant Public

Comments and EPA’s Responses

In response to the proposed rule, EPA

received over 500 comments

representing the general public, national

and local environmental groups,

national and local lead-poisoning

prevention advocacy groups, the lead

mining and manufacturing industry,

State and local governments, other

Federal Agencies, community-based

organizations, and Federal Advisory

Committees, among others. These

comments address numerous issues,

including EPA’s interpretation of the

statutory requirements, the policy basis

for the standards, the Agency’s technical

analysis, and the Agency’s decisions

regarding the standards and other

regulatory requirements. As noted

previously, the RTC document contains

EPA’s detailed characterizations and

responses to all significant public

comments.

This section of the preamble presents

in summary form, the characterizations

and responses to the comments on the

issues that EPA believes are of greatest

interest to the public. These comments,

specifically, are as follows: (1) It is not

appropriate under the statutory

requirements of Title X, or from a policy

perspective, to consider costs in the

development of the hazard standards;

(2) standards would fail to protect

children in inner-city neighborhoods

who are at greatest risk; (3) the dust

hazard standard should be significantly

lower; and (4) EPA should provide a

better explanation of the differences

between the TSCA section 403 hazard

standards for soil and the Superfund

approach for addressing lead in soil.

A. Consideration of Costs in Developing

Dust and Soil Hazard Standards

As discussed extensively in the

preamble to the proposed rule, this

preamble and the RTC document, EPA

chose to base its dust and soil hazard

standards on consideration of the

potential for risk reduction of actions

that may be taken (considering

uncertainties in the data and 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. Further, the

Agency has decided to base the hazard

standards on the levels at which, on a

national level, risks justify abatement in

order to comply with the statutory

standard that the hazard levels are those

that ‘‘would result’’ in adverse health

effects. EPA has noted, however, in

various places throughout this

preamble, that temporary measures and

interim controls can be appropriate in

many situations. The analysis of

abatement, as noted further below, is

EPA’s analytical model. The Agency

may not require any particular action to

be taken.

A number of comments from some

advocacy groups and some government

organizations expressed general

disagreement with this approach from

both a legal and policy standpoint.

Other comments provided detailed

arguments both for and against this

approach. EPA responds in the RTC

document to the more detailed

arguments raised by these comments.

However, the Agency believes it is

appropriate to discuss the issue more

generally in this preamble to clear up

important issues and to allay apparent

fears of some members of the public.

Comments criticizing EPA’s use of

cost-benefit balancing generally argued

that it is inappropriate to make

decisions regarding the selection of

hazard standards based on cost or other

risk management considerations.

Serious concern was expressed that EPA

modified health-based protective

standards by cost, or feasibility,

considerations and that scientific

decisions about a health based standard

1232 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

cannot be modified by such

considerations. These comments argued

that EPA should have made decisions

by tying hazard standards to a target

blood lead level. Costs and other risk

management factors should only be

considered by persons implementing

the standards.

EPA believes it is necessary to explain

how cost-benefit balancing was used in

this rulemaking. First, the decision to

use a cost-benefit balancing approach is

within the Agency’s statutory authority.

Title X and TSCA Title IV neither

require nor preclude the consideration

of costs in setting the standards. EPA’s

interpretation of the statute, however,

shows that an approach that uses costbenefit balancing is consistent with the

statutory language and legislative

history, as described more fully in the

proposal (63 FR at 30312-30314), earlier

in this preamble and the RTC document.

A cost-benefit balancing framework

provides EPA with an approach to factor

uncertainty in scientific data into the

decisionmaking and to set standards

where there are no distinct boundaries.

For this action, EPA’s dilemma is to

choose as a hazard that level of lead

above which the Agency is reasonably

confident that adverse effects would

result. Below that level there may still

be adverse effects, but the weight of

scientific evidence indicating adverse

effects is not as great. This formulation,

of course, is an over simplification by

necessity. The Agency is tasked with

line drawing by Congress in a

circumstance where there are no clear

lines. At the simplest level, no one can

say that 1,201 ppm of lead in soil is

worthy of abatement and 1,199 ppm is

not. As a result, consistent with the

applicable statute, EPA used a balancing

approach to pick the cutoff level above

which a regulatory hazard exists.

EPA’s approach first, and foremost,

considers the weight of evidence as to

whether dust or soil lead will actually

result in adverse effects. The surrogate

for adverse effects is a consideration of

blood lead levels and the potential

effects elevated blood-lead levels can

have on intelligence and lifetime

earnings. Reduction in blood lead levels

and, presumably, increased lifetime

earnings are then related to reduction in

environmental levels. No one would

dispute that the higher the

environmental lead levels are in any

particular medium (e.g., soil or dust),

the greater the likelihood of increased

blood-lead due to exposure from that

medium. At low environmental lead

levels, there is less confidence that any

specific medium is responsible for

blood-lead level increases. EPA’s

problem is drawing the line at which

concern for exposure to lead from paint,

dust, and soil diminishes that is, those

levels below which EPA will decide a

regulatory hazard does not exist.

EPA, using the best scientific

evidence it had, did the line drawing by

assigning a monetary value to the health

effects that will be prevented

(‘‘benefits’’) and evaluating whether

elimination (abatement) of the lead

hazard that causes these effects is

commensurate with the societal

resources (determined by the costs of

abatement) that would be expended by

doing the abatement. This gives EPA a

way to evaluate the certainty of the

scientific evidence and develop the

confidence it needs to determine that

the levels it has chosen would result in

adverse effects. Essentially, in this area

of scientific uncertainty about risk, EPA

is more willing to say that a regulatory

hazard exists if it can find that costs of

abatement are expected to be

reasonable. Costs, of course, are given

far less weight (or maybe no weight at

all) in circumstances in which adverse

effects are a certainty. Certainty simply

does not exist at the lower lead levels

with which the Agency is dealing in this

rule.

Two salient points need to be

reiterated here on how a cost-balancing

analysis was used in this rulemaking. In

the first place, for this rule, cost-benefit

balancing is a useful method for

decision making within the range of

uncertainty in the Agency’s analyses. In

any event, use of the analysis only helps

define the boundaries of the inquiry and

is not a sole basis for any decision. Once

EPA decided the range of options, the

Agency chose the levels within those

ranges. Second, EPA used the normative

cost-benefit analysis only to compare

options with the understanding that the

relative balance of costs and benefits

estimated should be reflective of the

relative balance of actual costs and

benefits. Thus, decision makers still

needed to exercise judgement. There is

no ‘‘black box’’ into which numbers are

entered and a decision comes out.

The comments that object to EPA’s

approach for hazard determination for

dust and soil offer as an alternative

determination of hazards by reference

only to environmental levels that are

associated, through modeling, with a

percentage of children exceeding

various blood lead levels. For example,

a hazard standard could be that level at

which models show no more than 5%

of children would exceed 10 μg/dL of

blood lead. This type of standard would

be based solely on the toxicity of lead

(at a particular blood level) and the

potential exposure. While EPA did use

this method for picking the initial

candidate hazard levels, the Agency

declined to use this method for

choosing hazards.

The reasonableness of EPA’s approach

is supported to a large extent by the fact

that the Agency received several

comments recommending particular

blood levels and percentages but no

comment provided EPA with any kind

of rational basis for choosing the

standard based on those levels and

percentages. Most of these comments

argued for having no more than 5% of

children above 10 μg/dL. However, they

provided no rationale for saying why

this would meet the ‘‘would result’’

standard for determining lead-based

paint hazards (i.e., why shouldn’t we

have zero children above 10 μg/dL, or

why 10 μg/dL is the proper number for

the hazard determination and not a

higher or lower number).

EPA’s view of the cost-benefit

approach points out another

misconception in the comments about

cost-benefit analysis. This

misconception is that EPA’s approach is

not health-based, but instead modifies a

protective standard based on cost

considerations. Commenters also seem

to believe that the Agency is using cost

considerations to leave children

unprotected. This is not the case.

Instead, as discussed above, EPA

evaluated different options within the

range of scientific uncertainty provided

by the two models used in the Agency’s

analyses. While it is true that as levels

get higher, the certainty regarding the

probability of harm increases, this does

not mean that lower levels should be

discounted or never addressed. It may

mean, however, that as you go lower,

the levels are less likely to meet the goal

of this rule to set levels at which all

abatements are specified to be

conducted in a specific way. For

purposes of setting such a national

standard, EPA believes that it is

reasonable to choose a level within the

range at which there is greater certainty

regarding the probability of harm, being

always mindful of the need to advise the

public that lower levels are not risk-free

and may in individual cases present

significant risks.

Given the range of uncertainty shown

in its analyses for this rule, EPA is

choosing an option that the Agency

believes provides protection, and at

which there is a higher level of certainty

that in all cases abatement is likely to

reduce risks significantly. EPA has set

its dust and soil hazard standards at the

lowest levels at which it believes acrossthe-board abatement and its associated

expenditure of resources is justified.

Evaluation of resource allocation, of

which costs are a measure, is a method

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1233

that was used in this rule as a tool to

make decisions within a set range of

uncertainty.

Finally, EPA’s hazard standards

should not be considered in isolation,

but must be considered along with the

Agency’s tiered approach for paint and

soil. Under this approach, the Agency

recognizes that risks could exist below

the hazard standard and recommends

that organizations and individuals may

want to consider taking some action,

informed by knowledge of local

circumstances, at levels below the

hazard levels.

B. Standards Do Not Protect Children at

Greatest Risk

Groups representing environmental

justice and children’s health protection

interests argued that the standards do

not protect children at greatest risk.

Some argued that the 1 to 5%

probability level for exceeding 10 μg/dL

(EPA’s basis for choosing the initial

candidate hazard levels in the final rule

and the Agency’s basis for evaluating

lead-contaminated dust and soil in the

proposed rule) would result in no

improvement because the percentage of

children with elevated blood lead levels

is already below 5%. Therefore, the

populations with the highest blood lead

levels would not benefit from the

standards.

EPA strongly disagrees with this

assertion and, in fact, has concluded

that the exact opposite is true. The

argument that the 1 to 5% probability

criteria would result in no improvement

for children at risk reflects confusion

with respect to the national blood-lead

data and risk to individual children.

The national blood-lead data is

composed of millions of children

exposed to a broad variety of

environmental-lead conditions. As such,

it actually consists of a broad range of

individual risks ranging from near zero

to levels above 50% for children

exposed to the very worst conditions.

The average population risk is just

below 5%. Children in at-risk

communities tend to have the higher

individual risk, as borne out by the

higher prevalence of elevated blood lead

levels in these communities (e.g., > 20%

for African American children living in

pre-1950 housing).

In fact, the hazard standards identify

a higher percentage of African-American

children than any other group.

Moreover, instead of offering more

protection to children in at-risk

communities, more stringent standards

may actually afford less protection to

these children by diluting the resources

available to address hazards in these

communities.

C. Dust-Lead Hazard Standard Should

be Significantly Lower

Several comments argued that the

dust-lead hazard should be significantly

lower, in the 5 to 10 μg/ft2 range. They

claimed that a hazard should be found

because more than 5% of children

would have blood lead levels above 10

μg/dL. This recommendation is based

on several analyses including an

independent analysis of the Rochester

Lead-in-Dust Study and the so-called

HUD pooled analysis. According to

these commenters, these analyses show

that significant risk exists where floor

dust-lead levels are below 10 μg/ft2.

EPA agrees that significant risks

should be addressed but disagrees with

the approach of these commenters. First,

as noted above, these comments

provided no rational basis for deciding

that a regulatory hazard exists based

solely on environmental levels

associated with particular blood lead

levels. Nevertheless, EPA concludes

after review of these comments and

analyses that the results showing more

than 5% of children exceed 10 μg/dL at

the low environmental levels were

achieved by focusing almost exclusively

on the contribution of dust-lead to

exposure and not adequately accounting

for the contribution of soil and

deteriorated lead-based paint to

exposure. When exposure to these other

sources is adequately accounted for, as

EPA believes was done in its analysis,

significant risk attributable to dust-lead

is not found until dust-lead levels on

floors reach 40 μg/ft2.

The data also indicate that to make

predictions of risk based exclusively on

dust-lead measurements would be an

inefficient and imprudent approach. An

examination of the Rochester data

reveals that in practically every case

where there was a child with an

elevated blood lead level and floor dust

lower than 40 μg/ft2, soil-lead levels

were elevated and/or deteriorated leadbased paint was present. Moreover, in

most houses with dust-lead levels below

40 μg/ft2, children did not have elevated

blood lead levels because other

significant sources of exposure were not

present.

EPA believes that the abovementioned empirical data supports its

view that it is more technically correct

to assess and control exposure in all

three media, as opposed to taking an

approach that focuses exclusively on

dust. Given the uncertainty that exists

with respect to the contribution to

exposure presented by each medium

individually, the Agency believes that it

is prudent to control exposure from the

combination of paint, dust, and soil

together rather than individually. Also,

control of all three media also prevents

recontamination of one medium by

another, making control efforts more

effective.

D. Relationship of Soil Hazard Standard

to Superfund Soil Cleanup Standards

Several commenters expressed

concern about the difference between

the TSCA approach for addressing lead

in soil in pre-1978 residential property

and the approach under programs

administered by the Office of Solid

Waste and Emergency Response

(OSWER) specifically, Superfund sites

and RCRA Corrective Action Facilities.

Responses to comments on the details of

the differences in the programs are

addressed in the RTC document. In this

section, however, EPA responds

generally to issues raised on the

relationship between the programs

administered by OSWER and TSCA. In

general, comments identified concerns

that differences in the two programs

could cause confusion and that persons

responsible for cleanup under the

OSWER programs could use the TSCA

standard to avoid taking response

actions to achieve protection.

As a preliminary matter, EPA

emphasizes that at lead-contaminated

residential sites both TSCA and the

OSWER programs seek to protect the

health of the most susceptible

population (children under 6 years of

age) and to promote a program that

assesses and addresses risk. The

approaches taken by the various

programs share many important aspects,

but also differ in some respects because

of their purposes. The TSCA program is

guided by this section 403 rule, which

identifies lead-base paint hazards,

which consist of lead paint and leadcontaining residential dusts and soils

that the Agency considers to be hazards

under applicable statutory criteria.

Guidance for the OSWER programs is

provided by the 1994 Revised Interim

Soil Lead (Pb) Guidance for CERCLA

Sites and RCRA Corrective Action

Facilities (OSWER Directive # 9355.4-

12, 1994) and Clarification to the 1994

Revised Interim Soil Lead (Pb) Guidance

for CERCLA Sites and RCRA Corrective

Action Facilities (OSWER Directive #

9200.4-27P, August 27, 1998) (Refs. 15

and 16).

The EPA programs that implement the

RCRA and CERCLA statutes rely on the

IEUBK model for relating environmental

levels to blood lead levels in children.

The OSWER soil lead guidance

recommends that the IEUBK Model be

applied to utilize site-specific

information that can be very important

in evaluating the risks at hazardous

1234 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

waste sites with residential exposure

scenarios. This section 403 rule also

employs analyses that have relied on the

IEUBK Model and the empirical model

which employs analyses based on

empirical data.

In the absence of site-specific

information at hazardous waste sites,

EPA believes that soil lead levels above

400 ppm may pose a health risk to

children through elevated blood lead

levels. The 400 ppm screening level

identified in the OSWER soil lead

guidance is consistent with both the

children’s play area hazard

determination identified in this rule and

the initial candidate hazard level

discussed in this preamble. Site-specific

information at hazardous waste sites

would provide a basis to identify a

different soil lead level that would be

protective of health. The TSCA soil

hazard levels of 400 ppm (play areas)

and an average 1,200 ppm (rest of yard)

should not be understood as a minimum

cleanup level for lead in soils at

hazardous waste sites and levels greater

than these could be consistent with

CERCLA requirements, depending on

site-specific factors. Soil lead levels less

than these still may pose serious health

risks and may warrant timely response

actions including abatement. The

hazard standard in this TSCA rule was

intended as a ‘‘worst first’’ level that

will aid in setting priorities to address

the greatest lead risks promptly at

residential and child-occupied facilities

affected by lead-based paint.

In contrast with the section 403 rule,

which establishes minimum national

standards that are designed to be used

at millions of residential properties and

child-occupied facilities across the

nation, the studies that take place at

CERCLA or RCRA involve multiple

hazardous substances with potentially

numerous sources of contamination and

multiple pathways of exposure that

require that response levels be

developed with site-specific

information. Other statutory and

regulatory criteria that would typically

be considered in determining a final

clean-up number include: long-term

effectiveness and permanence; and

reduction of toxicity, mobility, or

volume through treatment; short-term

effectiveness; implementability; cost;

State acceptance; and community

acceptance.

V. References

The official record for this rulemaking

has been established under docket

control number OPPTS–62156, and the

public version of the official record is

available for inspection as specified in

Unit I.B.2. The following is a listing of

some of the documents that have been

placed in the official record for this

rulemaking, including those specifically

referenced in this rulemaking.

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

K.M. Flegal, T.D. Matte, E.W. Gutiter,

and D.C. Paschal. 1994. ‘‘Blood Lead

Levels in the U.S. Population: Phase I of

the Third National Health and Nutrition

Examination Survey (NHANES III, 1988

to 1991).’’ Journal of the American

Medical Association. 272(4):277-283.

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

R.A. Kramer, D.C. Paschal, K.M. Flegal,

and T.D. Matte. (1994) ‘‘The Decline in

Blood Lead Levels in the United States:

The National Health and Nutrition

Examination Surveys (NHANES).’’

Journal of the American Medical

Association. 272(4):284-291.

3. CDCP. (1991, October) Preventing

Lead Poisoning in Young Children: A

Statement by the Centers for Disease

Control.

4. CDCP. (1997, February 21)

‘‘Update: Blood Lead Levels-U.S., 1991-

1994.’’ Morbidity and Mortality Weekly

Report. 46(7):141-145.

5. HUD. (1995, June) HUD Guidelines

for the Evaluation and Control of LeadBased Paint Hazards in Housing.

6. HUD. (1995) The Relation of LeadContaminated House Dust and Blood

Lead Levels Among Urban Children.

Volumes I and II. Final report to U.S.

HUD from the University of Rochester

School of Medicine, Rochester, NY and

The National Center for Lead Safe

Housing, Columbia, MD.

7. USEPA. (1990, January) ‘‘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.’’ EPA-SAB-CASAC-90-002.

January.

8. USEPA. (1994) Reducing Lead

Hazards When Remodeling Your Home.

EPA 747-R-94-002.

9. USEPA, OPPT. (1995, April) Report

on the National Survey of Lead Based

Paint in Housing - Base Report. EPA

747-R-95-003.

10. USEPA, OPPT. (1995, April).

Report on the National Survey of Lead

Based Paint in Housing - Appendix II:

Analysis. EPA 747-R-95-005.

11. USEPA. (1995, April) Report on

the National Survey of Lead-Based Paint

in Housing. Appendix I: Design and

Methodology. EPA 747-R95-004.

12. USEPA. (1997, December) Risk

Analysis to Support Standards for Lead

in Paint, Dust, and Soil. Volumes I and

II. EPA 747-R-97-006.

13. USEPA. (1998) Economic Analysis

of TSCA Section 403: Lead-Based Paint

Hazard Standards.

14. USEPA. (2000) Economic Analysis

of TSCA Section 403: Lead-Based Paint

Hazard Standards.

15. USEPA. (1994) 1994 Revised

Interim Soil Lead (Pb) Guidance for

CERCLA Sites and RCRA Corrective

Action Facilities, OSWER Directive

#9355.4-12, 1994.

16. USEPA. (1998, August 27)

Clarification to the 1994 Revised Interim

Soil Lead (Pb) Guidance for CERCLA

Sites and RCRA Corrective Action

Facilities, OSWER Directive #9200.4-

27P.

17. USEPA. (1996) Urban Soil Lead

Abatement Demonstration Project,

Volume I: EPA Integrated Report #600/

P93/001aF.

VI. Regulatory Assessment

Requirements

A. Executive Order 12866

Under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993),

the Office of Management and Budget

(OMB) has designated this an

‘‘economically significant regulatory

action,’’ because this action 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 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. This

rulemaking was therefore submitted to

OMB for review under this Executive

Order, and any changes made during

that review have been documented in

the public version of the official record.

In addition, while EPA does not

believe that this action, in and of itself,

imposes any requirements, EPA has

prepared an economic analysis of the

potential impacts of this action, which

is contained in a document entitled

Economic Analysis of Toxic Substances

Control Act Section 403: Lead-Based

Paint Hazard Standards (Ref. ). The

Agency believes that, in establishing the

standards, it is reasonable 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 analysis, in

conjunction with other considerations,

helped the decision-makers to select the

final hazard standards presented in this

document. The analysis is available as

a part of the public version of the

official record for this action and is

briefly summarized here.

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1235

Building on the economic analysis for

the proposed rule (Ref. ?), which is

summarized in Unit XII of the proposed

rule (63 FR at 30349-30351), the final

economic analysis contains one major

change. For the final rule, EPA separtely

assessed the costs and benefits

associated with a separate soil standard

for play areas and presented the results

in Appendix 7 of the Economic

Analysis. The following summary of the

economic analysis focuses on this

change. A summary of the rest of the

analysis was presented in the proposed

rule (63 FR at 30349–30351).

In this additional analysis, the revised

model goes through a three-step process

to estimate which homes might incur a

soil abatement and what parts of the

yard might be addressed. The first two

steps are the same as the original model,

a third step was added to address the

play area issue. In the original model, if

the home’s average of near and remote

soil concentrations did not exceed the

standard, then the model assumed that

no soil abatements would occur. In the

revised model, if the average soil

concentrations were below the soil

standard, then the play area

(represented by the remote area) soil

concentration was compared to the

standard. If this alone exceeded the

standard, then the model assumed that

the play area soil would be removed and

replaced.

The Agency notes that the costs

presented here for soil response actions

are based upon the assumption that

those responses would be soil

abatement. As noted previously in this

preamble, in performing its analyses for

this rule, the Agency could not

quantitatively compare interim control

strategies with abatement strategies

because there are only limited data

available on the effectiveness of interim

controls over extended periods of time,

and those data which are available are

not suitable for quantitative

comparisons with abatements.

Nevertheless, experience with interim

control programs is increasing and

certain organizations, particularly

public health and housing agencies,

believe they have been able to develop

effective programs for interim controls

which achieve virtually the same degree

of risk reduction as do abatement

programs, but at much reduced cost.

Thus, to the extent that interim control

strategies are used rather than

abatement, the actual costs may be

different from those presented below.

The play area is assumed to be much

smaller than the entire remote area of

the yard, and separate soil intervention

unit costs were estimated for the play

area. The costs assume that the average

play area for a single-family home is 200

square feet, and the average play area for

a multi-family building is 400 square

feet. The play area soil intervention

costs are estimated to be: $1,070 for a

single-family house ($1,738 if the soil is

hazardous), and $1,566 for multi-family

buildings ($2,903 if the waste is

hazardous). In addition to these soil

intervention costs, each home incurs a

dust clean-up. Because dust clean-ups

are required for certain other

interventions, a particular home may

already be incurring dust clean-up costs

and would not incur a second set of

dust clean-up costs.

The total costs (estimated over a 50–

year span, and discounted at 3%) for the

final dust and soil standards of 40 μg/

ft2 for floor dust, 250 μg/ft2 for window

sill dust and 1,200 ppm for soil, are

estimated to be $69 billion, while the

total estimated benefits are $192 billion

using the IEUBK model and $49 billion

using the empirical model, resulting in

estimated net benefits of $123 billion

using the IEUBK model and $20 billion

using the empirical model. About 26.7

million homes are projected to exceed

one or more of the standards, and the

Agency projected approximately 46.0

million children would experience

reduced exposure to household lead in

soil, dust, and paint.

B. Regulatory Flexibility Act

Pursuant to section 605(b) of the

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

et seq.), the Agency hereby certifies that

this final rule will not have a significant

economic impact on a substantial

number of small entities. The factual

basis for the Agency’s determination is

presented in the small entity impact

analysis prepared as part of the

economic analysis for this rule (Ref. 14),

and is briefly summarized here.

It is important to first note that this

rule does not, in and of itself, mandate

any action, or directly impose any costs.

Nevertheless, since the Agency

recognizes that the existence of the

hazard standards may influence the

decisions or actions of owners of target

housing, the Agency has considered the

potential costs and benefits associated

with the possible actions that a small

entity could or might take based on the

hazard standard. In addition, EPA has

already promulgated several regulations

implementing other sections of Title X

that use or reference the hazard

standards contained in this rule, and

also has a few other related regulations

under development. In promulgating

these regulations, the Agency has and

will continue to consider the potential

adverse impacts on small entities in the

context of those regulations, and in

compliance with the RFA. In general,

EPA strives to minimize potential

adverse impacts on small entities when

developing regulations to achieve the

environmental and human health

protection goals of the statute, and the

Agency.

For the purpose of analyzing the

potential impacts of this rule on small

entities, EPA used the definition for

small entities that is found in section

601 of the RFA. Under section 601,

‘‘small entity’’ is defined as: (1) A small

business that meets Small Business

Administration (SBA) size standards

codified at 13 CFR 121.201 which uses

the NAICS codes to categorize

businesses; (2) a small governmental

jurisdiction that is a government of a

city, county, town, school district or

special district with a population of less

than 50,000; and (3) a small

organization that is any not-for-profit

enterprise which is independently

owned and operated and is not

dominant in its field. The SBA size

standard for the types of small

businesses potentially impacted by this

rule is $5 million in annual revenues for

operators of multi-family housing or

apartment buildings (NAICS code

531110 and 531311).

It its analysis, the Agency has

assumed that this rule would impact

small businesses that engage in leadbased paint activities (i.e., abatement,

risk assessment, etc.), small businesses

that offer LBP activity related training,

small businesses that own or manage

rental properties involving target

housing, small not-for-profit

organizations that are engaged in LBP

activities and are not dominant in their

field, and small governmental

jurisdictions that receive assistance

through Federal housing programs (i.e.,

city and county public housing

authorities). By definition, States and

Federal agencies are not small.

Based on the analysis, the Agency

estimates that approximately 99% of the

firms would have less than a 1% impact

on revenues due to this rule, and

approximately 1% of firms could

experience impacts between 1% and 3%

of rental revenue. A comparison of

annual compliance costs to annual

rental income is equivalent to the

commonly used ratio of compliance

costs to sales. Although the rule could

impact a substantial number of small

entities, this analysis indicates that the

potential impact should not be

significant.

Information relating to this

determination has been provided to the

Chief Counsel for Advocacy of the Small

Business Administration upon request,

1236 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

and is included in the public version of

the official record for this rulemaking.

C. Paperwork Reduction Act

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

Paperwork Reduction Act (PRA) (44

U.S.C. 3501 et seq.) 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.

This final regulatory action does not

contain any information collection

requirements that require additional

OMB approval 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 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.

D. Unfunded Mandates Reform Act

Pursuant to Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA),

Public Law 104–4, EPA has determined

that this rule does not contain a Federal

mandate that may result in expenditures

of $100 million or more for State, local,

and tribal governments, in the aggregate,

or the private sector in any 1 year. As

indicated previously, this rule does not,

in and of itself, mandate any action, or

directly impose any costs. Nevertheless,

the Agency recognizes that the existence

of the hazard standards may influence

the decisions or actions of State, local or

tribal governmental officials as they

relate to lead-based paint activities, i.e.,

hazard interventions and risk

assessments. In addition, EPA has

already promulgated several regulations

implementing other sections of Title X

that use or reference the hazard

standards contained in this rule, and

has a few other related regulations

under development. In promulgating

these regulations, the Agency has and

will continue to consider the potential

impacts on State, local or tribal

governments.

The UMRA requirements in sections

202, 204, and 205 do not apply to this

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

rule does not contain any regulatory

requirements that might significantly or

uniquely affect small governments.

E. Executive Order 13132

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999), requires EPA to develop an

accountable process to ensure

‘‘meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications.’’ ‘‘Policies that have

federalism implications’’ are defined in

the Executive Order to include

regulations that have ‘‘substantial direct

effects on the States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government.’’

This final rule does not have

federalism implications, because it will

not have substantial direct effects on the

States, on the relationship between the

national government and the States, or

on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132. Although the

standards established by this regulation

may be adopted by any State, this

regulation does not contain any

mandates, and will not, therefore,

impose any substantial direct costs on

States. Nor would the rule substantially

affect the relationship between the

national government and the States, or

the distribution of power and

responsibilities among the various

levels of government. Thus, Executive

Order 13132 does not apply to this rule.

Although section 6 of Executive Order

13132 does not apply to this rule, EPA

involved State and local governmental

agencies in an extensive ‘‘dialogue’’

process, which is discussed in more

detail in Unit II of the preamble to the

proposal (63 FR at 30307). During

development of the proposed rule, EPA

also consulted with the States at

meetings of the Forum on State and

Tribal Toxics Action and the annual

EPA meeting with State program

representatives.

F. Executive Order 13084

Under Executive Order 13084,

entitled Consultation and Coordination

with Indian Tribal Governments (63 FR

27655, May 19, 1998), EPA may not

issue a regulation that is not required by

statute, that significantly or uniquely

affects the communities of Indian tribal

governments, and that imposes

substantial direct compliance costs on

those communities, unless the Federal

government provides the funds

necessary to pay the direct compliance

costs incurred by the tribal

governments, or EPA consults with

those governments.

This rule does not significantly or

uniquely affect the communities of

Indian tribal governments, nor does it

impose substantial direct compliance

costs on such communities.

Accordingly, the requirements of

section 3(b) of Executive Order 13084

do not apply to this rule.

Nevertheless, although tribal

governments are not required to

administer any of the Lead Programs,

the Agency consulted with interested

Tribal government representatives as

part of the Forum on State and Tribal

Toxics Action and EPA’s annual

national lead meeting with States and

tribes. The Agency has also provided

extensive technical and financial

assistance.

G. Executive Order 12898

Pursuant to Executive Order 12898,

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 action on the environmental and

health conditions in minority and lowincome populations. The Agency’s

standards will protect children in

minority and low-income communities

from disproportionate burdens. This is

based on the findings of the Agency’s

economic analysis which shows that

non-white populations receive more of

the public health benefit associated with

the standards.

In addition, EPA consulted with

representatives of a variety of interests,

including members of environmental

justice advocacy groups. The Dialogue

Process, which EPA specifically

established to provide input into the

decision making process, included a

low-income parent, two members of the

National Environmental Justice

Advisory Council, and representatives

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1237

of two other groups who spoke on

behalf of disadvantaged populations.

These individuals comprised 20% of the

membership of the process. Moreover,

during the public comment period, EPA

held two public meetings where

residents of low-income communities

and representatives of environmental

justice groups offered public comment

to EPA. The Agency also received

written comments from 50 groups and

several hundred individuals raising

environmental justice concerns.

Consequently, EPA believes that it has

complied with the provision of the

executive order to provide

representatives of environmental justice

interests to participate fully in the

process and to provide input and

comment to the Agency.

Furthermore, recognizing that these

standards would be used by and affect

millions of people that do not have a

comprehensive understanding of the

science of lead hazards, EPA made a

conscious decision to make the

standards simple. For example, instead

of joint standards that might have better

reflected overall risk under some

circumstances, EPA chose to establish

media-specific standards because they

are easier to understand and use.

Outreach documents (e.g, fact sheets)

are written and designed with the

specific objective of making the

regulation easy for the public to

understand. In addition, EPA’s broader

lead outreach program includes

extensive elements that specifically

target non-white and low income

communities.

H. Executive Order 13045

Executive Order 13045, entitled

Protection of Children from

Environmental Health Risks and Safety

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

applies to this rule because OMB has

determined that this rule is

‘‘economically significant’’ as defined

under Executive Order 12866 (see Unit

VI.A.). In addition, the environmental

health or safety risk addressed by this

rule may have a disproportionate affect

on children.

In accordance with section 5(501) of

Executive Order 13045, EPA has

evaluated the environmental health or

safety effects of lead-based paint on

children in the selection of the hazard

standards contained in this rule. The

results of this evaluation are contained

in the ‘‘Risk Analysis to Support

Standards for Lead in Paint, Dust, and

Soil’’ and the supplement to this

analysis. Copies of these documents

have been placed in the public version

of the official record for this rule. This

analysis focused almost exclusively on

assessing exposure and risk to young

children.

Moreover, the standards selected by

EPA are designed first and foremost to

protect children from lead in residential

paint, dust, and soil. In this regard, EPA

believes that it has selected the most

protective standards possible. Although

the Agency could have selected

numerically more stringent standards,

EPA concluded that more stringent

standards would afford less protection

to children because EPA believes that

limited resources would be diluted and

possibly diverted from children who are

at greatest risk. The standards will also

protect children by supporting

implementation of other provisions of

the national lead program, such as

hazard disclosure prior to the sale or

rental of most pre-1978 housing and

evaluation and control of lead-based

paint hazards and Federally-assisted

and Federally owned housing prior to

disposition.

I. National Technology Transfer and

Amendment Act

Section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (NTTAA), Public Law No.

104-113, section 12(d) (15 U.S.C. 272

note) 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, and

business practices) that are developed or

adopted by voluntary consensus

standards bodies. The NTTAA directs

EPA to provide Congress, through OMB,

explanations when the Agency decides

not to use available and applicable

voluntary consensus standards.

The Agency has determined that there

are no voluntary consensus standards

for lead-based paint hazards. However,

the Agency has, where appropriate,

referred to voluntary consensus

standards developed by such

organizations as the American Society

for Testing and Materials (ASTM) with

respect to sampling and analytical

methods.

J. Executive Order 12630

EPA has complied with Executive

Order 12630, entitled Governmental

Actions and Interference with

Constitutionally Protected Property

Rights (53 FR 8859, March 15, 1988), by

examining the takings implications of

this rule in accordance with the

‘‘Attorney General’s Supplemental

Guidelines for the Evaluation of Risk

and Avoidance of Unanticipated

Takings’’ issued under the Executive

Order.

K. Executive Order 12988

In issuing this rule, EPA has taken the

necessary steps to eliminate drafting

errors and ambiguity, minimize

potential litigation, and provide a clear

legal standard for affected conduct, as

required by section 3 of Executive Order

12988, entitled Civil Justice Reform (61

FR 4729, February 7, 1996).

VII. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a major rule may take effect,

the Agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and the Comptroller General of

the United States. EPA has submitted a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives and

the Comptroller General of the United

States. This rule is a ‘‘major rule’’ as

defined by 5 U.S.C. 804(2). A major rule

cannot take effect until 60 days after

date it is published in the Federal

Register or is submitted to Congress

whichever is later. This rule will take

effect on March 6, 2001.

List of Subjects in 40 CFR Part 745

Environmental protection, Hazardous

substances, Lead poisoning, Reporting

and recordkeeping requirements.

Dated: December 22, 2000.

Carol M. Browner,

Administrator.

Therefore, 40 CFR part 745 is

amended as follows:

PART 745—AMENDED

1. The authority citation for part 745

continues to read as follows:

Authority: 15 U.S.C. 2605, 2607, 2681–

2692 and 42 U.S.C. 4852d.

2. 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.

Subpart D—Lead-Based Paint Hazards

§ 745.61 Scope and applicability.

(a) This subpart identifies lead-based

paint hazards.

1238 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

(b) The standards for lead-based paint

hazards apply to target housing and

child-occupied facilities.

(c) Nothing in this subpart requires

the owner of property(ies) subject to

these standards to evaluate the

property(ies) for the presence of leadbased paint hazards or take any action

to control these conditions if one or

more of them is identified.

§ 745.63 Definitions.

The following definitions apply to

part 745.

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).

Chewable surface means an interior or

exterior surface painted with lead-based

paint that a young child can mouth or

chew. A chewable surface is the same as

an ‘‘accessible surface’’ as defined in 42

U.S.C. 4851b(2)). Hard metal substrates

and other materials that cannot be

dented by the bite of a young child are

not considered chewable.

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.

Deteriorated paint means any interior

or exterior paint or other coating that is

peeling, chipping, chalking or cracking,

or any paint or coating located on an

interior or exterior surface or fixture that

is otherwise damaged or separated from

the substrate.

Dripline means the area within 3 feet

surrounding the perimeter of a building.

Friction surface means an interior or

exterior surface that is subject to

abrasion or friction, including, but not

limited to, certain window, floor, and

stair surfaces.

Impact surface means an interior or

exterior surface that is subject to damage

by repeated sudden force such as certain

parts of door frames.

Interior window sill means the portion

of the horizontal window ledge that

protrudes into the interior of the room.

Lead-based paint hazard means

hazardous lead-based paint, dust-lead

hazard or soil-lead hazard as identified

in § 745.65.

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 dripline of a residential

building and the nearest property

boundary or between the driplines of a

residential building and another

building on the same property.

Play area means an area of frequent

soil contact by children of less than 6

years of age as indicated by, but not

limited to, such factors including the

following: the presence of play

equipment (e.g., sandboxes, swing sets,

and sliding boards), toys, or other

children’s possessions, observations of

play patterns, or information provided

by parents, residents, care givers, or

property owners.

Residential building means a building

containing one or more residential

dwellings.

Room means a separate part of the

inside of a building, such as a bedroom,

living room, dining room, kitchen,

bathroom, laundry room, or utility

room. To be considered a separate room,

the room must be separated from

adjoining rooms by built-in walls or

archways that extend at least 6 inches

from an intersecting wall. Half walls or

bookcases count as room separators if

built-in. Movable or collapsible

partitions or partitions consisting solely

of shelves or cabinets are not considered

built-in walls. A screened in porch that

is used as a living area is a room.

Soil sample means a sample collected

in a representative location using ASTM

E1727, ‘‘Standard Practice for Field

Collection of Soil Samples for Lead

Determination by Atomic Spectrometry

Techniques,’’ or equivalent method.

Weighted arithmetic mean means the

arithmetic mean of sample results

weighted by the number of subsamples

in each sample. Its purpose is to give

influence to a sample relative to the

surface area it represents. A single

surface sample is comprised of a single

subsample. A composite sample may

contain from two to four subsamples of

the same area as each other and of each

single surface sample in the composite.

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 (three 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)]/

(1+3+4).

Window trough means, for a typical

double-hung window, the portion of the

exterior window sill between the

interior window sill (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 as the window

‘‘well.’’

Wipe sample means a sample

collected by wiping a representative

surface of known area, as determined by

ASTM E1728, ‘‘Standard Practice for

Field Collection of Settled Dust Samples

Using Wipe Sampling Methods for Lead

Determination by Atomic Spectrometry

Techniques, or equivalent method, with

an acceptable wipe material as defined

in ASTM E 1792, ‘‘Standard

Specification for Wipe Sampling

Materials for Lead in Surface Dust.’’

§ 745.65 Lead-based paint hazards.

(a) Paint-lead hazard. A paint-lead

hazard is any of the following:

(1) Any lead-based paint on a friction

surface that is subject to abrasion and

where the lead dust levels on the

nearest horizontal surface underneath

the friction surface (e.g., the window

sill, or floor) are equal to or greater than

the dust-lead hazard levels identified in

paragraph (b) of this section.

(2) Any damaged or otherwise

deteriorated lead-based paint on an

impact surface that is caused by impact

from a related building component

(such as a door knob that knocks into a

wall or a door that knocks against its

door frame.

(3) Any chewable lead-based painted

surface on which there is evidence of

teeth marks.

(4) Any other deteriorated lead-based

paint in any residential building or

child-occupied facility or on the exterior

of any residential building or childoccupied facility.

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

hazard is surface dust in a residential

dwelling or child-occupied facility that

contains a mass-per-area concentration

of lead equal to or exceeding 40 μg/ft2

on floors or 250 μg/ft2 on interior

window sills based on wipe samples.

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

hazard is bare soil on residential real

property or on the property of a childoccupied facility that contains total lead

equal to or exceeding 400 parts per

million (μg/g) in a play area or average

of 1,200 parts per million of bare soil in

the rest of the yard based on soil

samples.

Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations 1239

(d) Work practice requirements.

Applicable certification, occupant

protection, and clearance requirements

and work practice standards are found

in regulations issued by EPA at 40 CFR

part 745, subpart L and in regulations

issued by the Department of Housing

and Urban Development (HUD) at 24

CFR part 35, subpart R. The work

practice standards in those regulations

do not apply when treating paint-lead

hazards of less than:

(1) Two square feet of deteriorated

lead-based paint per room or equivalent,

(2) Twenty square feet of deteriorated

paint on the exterior building, or

(3) Ten percent of the total surface

area of deteriorated paint on an interior

or exterior type of component with a

small surface area.

3. In § 745.223, by removing the

definitions for ‘‘Lead-contaminated

dust’’ and ‘‘Lead-contaminated soil,’’

and by revising paragraph (1) of the

definition of ‘‘Abatement,’’ to read as

follows:

§ 745.223 Definitions.

* * * * *

Abatement * * *

(1) The removal of paint and dust, the

permanent enclosure or encapsulation

of lead-based paint, the replacement of

painted surfaces or fixtures, or the

removal or permanent covering of soil,

when lead-based paint hazards are

present in such paint, dust or soil; and

* * * * *

4. In § 745.227, by revising paragraphs

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

(d)(7), (e)(7)(i), (e)(7)(ii), (e)(8)(ii),

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

redesignating paragraph (d)(8)(ii) as

paragraph (d)(8)(iii) and paragraph (h)

as paragraph (i), and by adding

paragraphs (d)(8)(ii), (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) The following surfaces which are

determined, using documented

methodologies, to have a distinct

painting history, shall be tested for the

presence of lead:

(i) Each friction surface or impact

surface with visibly deteriorated paint;

and

(ii) All other surfaces with visibly

deteriorated paint.

(5) In residential dwellings, dust

samples (either composite or singlesurface samples) from the interior

window sill(s) and floor shall be

collected and analyzed for lead

concentration 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 and

analyzed for lead concentration in the

following locations:

* * * * *

(7) For child-occupied facilities,

interior window sill and floor dust

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

analyzed for lead concentration in each

room, hallway or stairwell utilized by

one or more children, age 6 and under,

and in other common areas in the childoccupied facility where one or more

children, age 6 and under, are likely to

come into contact with dust.

(8) * * *

(ii) The rest of the yard (i.e., non-play

areas) where bare soil is present.

* * * * *

(e) * * *

(7) * * *

(i) If the soil is removed:

(A) The soil shall be replaced by soil

with a lead concentration as close to

local background as practicable, but no

greater than 400 ppm.

(B) The soil that is removed shall not

be used as top soil at another residential

property or child-occupied facility.

(ii) If soil is not removed, the soil

shall be permanently covered, as

defined in § 745.223.

(8) * * *

(ii) Following the visual inspection

and any post-abatement cleanup

required by paragraph (e)(8)(i) of this

section, clearance sampling for lead in

dust shall be conducted. Clearance

sampling may be conducted by

employing single-surface sampling or

composite sampling techniques.

* * * * *

(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 from one window trough (if

present) and one dust sample shall be

taken from the floors of each 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 each of 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 present) 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 child-occupied

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 clearance levels in

paragraph (e)(8)(viii) of this section 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 half 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 half the number of

subsamples in the composite sample,

the components represented by the

failed sample shall be recleaned and

retested.

(viii) The clearance levels for lead in

dust are 40 μg/ft2 for floors, 250 μg/ft2

for interior window sills, and 400 μg/ft2

for window troughs.

* * * * *

(h) Determinations. (1) Lead-based

paint is present:

(i) On any surface that is tested and

found to contain lead equal to or in

excess of 1.0 milligrams per square

centimeter or equal to or in excess of

0.5% by weight; and

(ii) On any surface like a surface

tested in the same room equivalent that

has a similar painting history and that

is found to be lead-based paint.

(2) A paint-lead hazard is present:

(i) On any friction surface that is

subject to abrasion and where the lead

dust levels on the nearest horizontal

surface underneath the friction surface

(e.g., the window sill or floor) are equal

to or greater than the dust hazard levels

identified in § 745.227(b);

(ii) On any chewable lead-based paint

surface on which there is evidence of

teeth marks;

(iii) Where there is any damaged or

otherwise deteriorated lead-based paint

on an impact surface that is cause by

1240 Federal Register / Vol. 66, No. 4 / Friday, January 5, 2001 / Rules and Regulations

impact from a related building

component (such as a door knob that

knocks into a wall or a door that knocks

against its door frame; and

(iv) If there is any other deteriorated

lead-based paint in any residential

building or child-occupied facility or on

the exterior of any residential building

or child-occupied facility.

(3) A dust-lead hazard is present in a

residential dwelling or child occupied

facility:

(i) In a residential dwelling on floors

and interior window sills when the

weighted arithmetic mean lead loading

for all single surface or composite

samples of floors and interior window

sills are equal to or greater than 40 μg/

ft2 for floors and 250 μg/ft2 for interior

window sills, respectively;

(ii) On floors or interior window sills

in an unsampled residential dwelling in

a multi-family dwelling, if a dust-lead

hazard is present on floors or interior

window sills, respectively, in at least

one sampled residential unit on the

property; and

(iii) On floors or interior window sills

in an unsampled common area in a

multi-family dwelling, if a dust-lead

hazard is present on floors or interior

window sills, respectively, in at least

one sampled common area in the same

common area group on the property.

(4) A soil-lead hazard is present:

(i) In a play area when the soil-lead

concentration from a composite play

area sample of bare soil is equal to or

greater than 400 parts per million; or

(ii) In the rest of the yard when the

arithmetic mean lead concentration

from a composite sample (or arithmetic

mean of composite samples) of bare soil

from the rest of the yard (i.e., non-play

areas) for each residential building on a

property is equal to or greater than 1,200

parts per million.

5. In § 745.325, by revising paragraphs

(d)(2)(iii)(A) and (d)(2)(iii)(B), by

redesignating (d)(2)(iv) and (d)(2)(v) as

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

by adding paragraphs (d)(2)(iii)(C),

(d)(2)(iii)(D), (d)(2)(iv), and (e), to read

as follows:

§ 745.325 Lead-based paint activities:

State and Tribal program requirements.

* * * * *

(d) * * *

(2) * * *

(iii) * * *

(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

standards for lead-based paint hazards

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 standards for lead-based paint

hazards established or revised by the

State or Indian Tribe pursuant to

paragraph (e) of this section.

(iv) The program elements required in

paragraph (d)(2)(iii)(C) and (d)(2)(iii)(D)

of this section shall be adopted in

accordance with the schedule for the

demonstration required in paragraph (e)

of this section.

* * * * *

(e) The State or Indian Tribe must

demonstrate that it has standards for

identifying lead-based paint hazards

and clearance standards for dust, that

are at least as protective as the standards

in § 745.227 as amended on February 5,

2001. A State or Indian Tribe with such

a section 402 program approved before

February 5, 2003 shall make this

demonstration no later than the first

report submitted pursuant to

§ 745.324(h) on or after February 5,

2003. A State or Indian Tribe with such

a program submitted but not approved

before February 5, 2003 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 February 5, 2003

shall make this demonstration in its

application.

[FR Doc. 01–84 Filed 1–4–01; 8:45 am]

BILLING CODE 6560–50–S