# Lead; Identification of Dangerous Levels of Lead

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URL: https://www.frixlaw.com/law-library/documents/fr%3A01-84

## Record

- **Collection:** Federal Register
- **Document type:** Rule
- **Published:** January 5, 2001
- **Citation:** 66 FR 1206

## Text

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 Lead-Based Paint Hazard Reduction Act of 1992, also known as “Title X (ten),” to establish standards for lead-based paint hazards in most pre-1978 housing and child-occupied facilities. This regulation supports the implementation of regulations already promulgated, and others under development, which deal with worker training and certification, lead hazard disclosure in real estate transactions, requirements for lead cleanup under State authorities, lead hazard evaluation and control in Federally-owned housing prior to sale and housing receiving Federal assistance, and U.S. Department of Housing and Urban Development (HUD) grants to local jurisdictions to perform lead hazard control. In addition, today's action also establishes, under authority of TSCA section 402, residential lead dust cleanup levels and amendments to dust and soil sampling requirements and, under authority of TSCA section 404, amendments to State program authorization requirements. By supporting implementation of the major provisions of Title X and by providing guidance to all owners and occupants of pre-1978 housing and child-occupied facilities, this regulation will help to prevent lead poisoning in children under the age of 6.

DATES:

This final rule is effective on March 6, 2001. This rule shall be promulgated for purposes of judicial review at 1 p.m. eastern daylight time on February 5, 2001.

FOR FURTHER INFORMATION CONTACT:

For general information contact
: Barbara Cunningham, Director, Office of Program Management and Evaluation, Office of Pollution Prevention and Toxics (7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: 202-554-1404; e-mail address: TSCA-Hotline@epa.gov.

For technical information contact
: Dave Topping, National Program Chemicals Division (7404), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 260-7737; e-mail address: topping.dave@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you must comply with other Title X regulations that are affected by today's action. The following table identifies potentially affected categories and entities:

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 programs
State and city public housing authorities, owners of multifamily rental properties that receive project-based 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

going directly to the Internet Home Page for this regulation at http://www.epa.gov/lead/leadhaz.htm and selecting the desired document. You can also go directly to the
Federal Register
listings at http://www.epa.gov/fedrgstr/ to obtain a copy of this final rule.

2.
In person
. The Agency has established an official record for this action under docket control number OPPTS-62156. The official record consists of the documents specifically referenced in this action, any public comments received during the comment period, and other information related to this action. This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official docket, which includes printed, paper versions of any electronic comments submitted during the comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260-7099.

II. Overview

A. Introduction

The Title X term “lead-based paint hazard” is intended to identify lead-based paint and all residential lead-containing dusts and soils regardless of the source of the lead, which, due to their condition and location, would result in adverse human health effects. One of the underlying principles of Title X is to move the focus of public and private sector decision makers away from the mere presence of lead-based paint, to the presence of lead-based paint hazards, for which more substantive action should be undertaken to control exposures, especially to young children. This regulation establishes hazard standards for residential lead-based paint, and residential dust and soil lead. The hazard standards for these three media, collectively, are statutorily defined as lead-based paint hazards.

B. Summary of Statutory Authority

The Residential Lead-Based Paint Hazard Reduction Act of 1992 was enacted as Title X of the Housing and Community Development Act of 1992. Title X establishes a comprehensive Federal program for reducing the risks from lead-based paint and certain lead hazards. The Title X program primarily gives authority to HUD and EPA, but affects a number of other Federal agencies. Among other things, Title X amended TSCA by adding TSCA Title IV, which specifically gives regulatory authority to EPA to cover, among other things, training of workers who deal with lead-based paint hazard abatement, the appropriate form of State and Tribal lead programs, and the identification of dangerous levels of lead. Title IV includes section 403. EPA is promulgating the standards for lead-based paint hazards under the authority of TSCA section 403, 15 U.S.C. 2683.

Section 403 requires EPA to promulgate regulations that “identify . . . lead-based paint hazards, lead-contaminated dust, and lead-contaminated soil” for purposes of the entire Title X. Lead-based paint hazards, under TSCA section 401 (15 U.S.C. 2681), are defined as conditions of lead-based paint and lead-contaminated dust and soil that “would result” in adverse human health effects (15 U.S.C. 2681(10)). Lead-based paint is defined by statute as paint with lead levels equal to or exceeding 1.0 milligrams per square centimeter (mg/cm
2
) or 0.5% by weight (see section 302(c) of the Lead-Poisoning Prevention Act (42 U.S.C. 4822(c)) and TSCA section 401(9) (15 U.S.C. 2681(9)). TSCA section 401 defines lead-contaminated dust as “surface dust in residential dwellings” that contains lead in excess of levels determined “to pose a threat of adverse health effects” (15 U.S. C. 2681(11)). TSCA section 401 defines lead-contaminated soil as “bare soil on residential real property that contains lead at or in excess of levels determined to be hazardous to human health” (15 U.S.C. 2681(12)).

EPA is also promulgating amendments to the regulations for lead-based paint activities under the authority of TSCA section 402 (15 U.S.C. 2682) and to the State and Tribal program authorization requirements under authority of TSCA section 404 (15 U.S.C. 2684). These changes are needed to ensure consistency among the various regulations covering lead risks under TSCA. Section 402 requires EPA to promulgate regulations establishing training and certification requirements for individuals and firms engaged in lead-based paint activities. Lead-based paint activities, in the case of target housing and child-occupied facilities, include risk assessment, inspection and abatement. See TSCA section 402(b)(1); 15 USC 2682(b)(1). To clarify this definition, EPA notes that lead-based paint activities do not include interim controls. These regulations “shall contain standards for performing lead-based paint activities, taking into account reliability, effectiveness, and safety” (15 U.S.C. 2682(a)(1)). Section 404 requires States and Tribes seeking to administer and enforce standards, regulations, or other requirements under section 402, 406, or both to seek authorization from EPA.

C. Guiding Principles

Reducing exposure to lead has been an important issue for EPA for more than 2 decades. Young children are especially vulnerable to the toxic effects of lead because their nervous systems are still developing and they absorb more of the lead to which they are exposed. Many of the health effects associated with lead are thought to be irreversible. Moreover, the effects at lower levels of exposure are often asymptomatic. In light of the impacts on children and the nature of the health effects, EPA's goal is to eliminate exposure to harmful levels of lead. This goal has informed Agency actions such as the decision to remove lead as an additive from gasoline as discussed in the preamble to the proposed rule (63 FR at 30305).

First and foremost, the Agency faces the difficulty of determining the level at which to set the standards given the uncertainties in information on cause and effect--what environmental levels in which specific medium may actually cause particular blood lead levels that are associated with adverse health effects. The Agency has tools, which are only generally consistent, that show that certain increases in environmental lead levels are associated with certain increases in blood lead levels. Given the range of uncertainty shown in its analysis supporting the establishment of a hazard level under this rule, EPA has developed a technical analysis that considers hazard standards for dust and soil at the lowest levels at which the analysis shows that across-the-board abatement on a national level could be justified. EPA recognizes, however that for any levels of lead in dust or soil judgment must be exercised as to how to treat the medium, and interim controls as well as abatement could be effective. In addition, EPA recommends that organizations and individuals consider some form of interim control in certain residential areas even where soil lead levels are below the hazard standard if there is a concern that children under 6 might spend substantial time in such areas, or there is potential for that soil to contribute to hazardous lead levels in play areas or dwellings. While the risks from lead at these lower levels are less than the hazard level, EPA believes that public health will be further protected if

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

standards for individuals and firms engaged in lead-based paint activities, and the pre-renovation education rule that requires renovation and remodeling contractors to provide the EPA pamphlet “Protect Your Family from Lead in Your Home” to occupants prior to the start of renovation and remodeling projects. In addition, under section 402 of TSCA, EPA is currently developing training and certification requirements for renovation and remodeling contractors whose activities may create lead hazards.

EPA and other Federal agencies continue to conduct field studies to identify and evaluate lower cost products and technologies for evaluating and controlling lead-based paint hazards. The findings of these studies are distributed to professionals through our lead hotline, EPA's website (www.epa.gov/lead) and at other agencies' websites, and through on-going contact with trade and professional associations. The standards, combined with these other efforts, provide a comprehensive program designed to reduce and eventually help eliminate lead in residential paint, dust, and soil as a cause of childhood lead poisoning.

Third, these standards are based on the best science available to the Agency. EPA recognizes, however, that the science is constantly developing and with it our understanding of the relationship between lead in the environment and human exposure and the relationship between exposure and health impacts. If new data become available (e.g., empirical data showing that very small amounts of deteriorated paint pose a serious health risk or data showing that hazard control activities are more effective at reducing long-term dust-lead levels than assumed by EPA), the Agency will consider changing the standards to reflect these data. If the data indicate that the standards should be changed and they meet EPA's quality criteria, the Agency will consider publishing the data for public review and comment and amending today's regulation.

D. Regulatory Approach

1.
Uniform national standards
. EPA is issuing uniform national standards in this rule. The rationale for adopting uniform national standards is found on pages 63 FR 30307 to 30308 of the preamble to the proposed rule. EPA summarizes this reasoning in the following paragraphs.

EPA stated that the relationship between environmental lead levels (from paint, dust, and soil) and their effects on the health of exposed children, which forms the basis for this rule, is complex, and is dependent upon numerous site-specific and child-specific factors. Where more site-specific factors can be considered on a smaller (residence or community) scale, estimates of the effects of environmental levels on blood lead can be more accurate. The data needed, however, are not available for communities nationwide. In contrast, national data on lead in paint, dust, and soil are currently available. Even if data were available, the residence or community scale standards would still not account for variability in exposure influenced by child-specific factors (e.g., hand-to-mouth behavior, hygiene, and nutrition). Detailed evaluations that considered the specifics of individual communities would generally require information for each residence to evaluate the impact of environmental lead on children.

In addition, uniform national standards provide a fixed basis of comparison for all homes. National standards can be used to compare properties and establish priorities. This would be extremely difficult to accomplish if there were the numerous standards specific to individual communities.

EPA also took into account that certain segments of the population have a higher incidence of elevated blood-lead levels (e.g., minority and low-income children). Because estimates of the relationship between environmental lead levels and children's health effects are not sufficiently refined to distinguish relationships for particular subsets of the general population of children, EPA is choosing to emphasize program implementation (e.g., training, education, and environmental justice grants), which the Agency considers a more effective and simpler approach to address vulnerable communities rather than setting community-specific standards. EPA preferred to establish a simple, set of standards that could easily be adopted by States, allowing them to tailor the standards, should they so choose. This allows States greater flexibility to establish and implement their programs while a national, baseline level of protection to children is maintained.

2.
Media-specific standards
. A second basic issue that shaped EPA's standard-setting approach involves the fact that a child's total lead exposure is the sum of contributions from numerous sources, including paint, dust, soil, and others. Specifically, EPA had to decide whether to set separate, independent standards for paint, dust, and soil or to integrate the standards.

Under the first option, EPA would establish a fixed standard for each medium without considering the varying conditions in the other media. For example, the soil standard would remain constant, regardless of whether dust lead levels were high or low. The chief advantage of this option is that the standards are simple to understand and use.

A potential disadvantage of this approach is that a standard could be established for a particular medium that does not consider the total exposure of a child (i.e., exposures from all other media). To address this potential shortcoming, the Agency considered candidate sets of standards for dust, lead, and paint together so that its comparisons of candidate standards reflected exposures to all media. Consequently, the standards, although they are medium-specific numbers will effectively identify hazards as long as all media are evaluated and compared to the standards.

Under the second option, EPA would set standards to account for total lead exposure from all media. Under a joint standard, the standard for each medium would vary, depending on the conditions in the other media. For a graphical [illustration of this option, see page 30308 of the preamble to the proposed rule. The major advantage of the joint standards is that they avoid anomalous situations. For example, it stands to reason that if both dust and soil measurements are just below the hazard levels--35 μg/ft
2
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

can be found on pages 30308 and 30309 of the preamble to the proposed rule.

E. Applicability and Uses of the Standards

The standards established in this rule apply to target housing (i.e., most pre-1978 housing) and child-occupied facilities (pre-1978 non-residential properties where children under the age of 6 spend a significant amount of time such as daycare centers and kindergartens). The standards are intended to be used prospectively. That is, they should be used to identify properties that present risks to children before children are harmed. This, of course, would not prevent them from being used retrospectively in the case of environmental intervention blood lead investigations and clearance of resulting lead hazard control activities.

These standards are not appropriate as the sole source of information to use when identifying the source of exposure for a lead-poisoned child. When a property is being evaluated in response to an identification of a lead-poisoned child, the risk assessor in cooperation with local public health officials should identify and consider all sources of lead exposure. For example, a risk assessor should consider lead in drinking water as well as the presence of any amount of deteriorated lead-based paint.

Within the scope of Title X, these regulatory standards will help support and implement major provisions of the statute. They will be incorporated into the risk assessment work practice standards, providing the basis for risk assessors to determine whether lead-based paint hazards are present. By helping to determine when a hazard is present, the standards will help determine when a hazard control activity must be performed by certified personnel. EPA further notes that only abatement of lead-based paint hazards specifically hazardous lead-based paint, dust-lead hazards or soil-lead hazards identified in 40 CFR 745.65 requires certified personnel. This is because “abatement” is defined in 40 CFR 745.223 as “measures designed to permanently eliminate lead-based paint hazards.” Thus, permanent elimination of lead-based paint, and dust or soil lead would not require the use of certified personnel unless lead-based paint hazards are present in those media.

States and Tribes wishing to obtain or retain authorization to administer and enforce training and certification programs must incorporate hazard standards as protective as the standards in this rule. Provisions for State and Tribal authorization are described at 40 CFR part 745, subpart Q. These standards will also help property owners comply with section 1018 by establishing what conditions must be disclosed to prospective purchasers and renters as
lead-based paint hazards
prior to the sale or rental of target housing. HUD, the Department of Defense (DoD), and other Federal agencies will use these standards in implementing or overseeing the evaluation and control of hazards in Federally-assisted housing and Federally-owned housing prior to disposition. (24 CFR part 35)

Under section 1018 of Title X (42 U.S.C. 4852d), EPA and HUD have jointly developed regulations requiring a seller or lessor of most pre-1978 housing to disclose the presence of any known lead-based paint and lead-based paint hazards to the purchaser or lessee (24 CFR part 35, subpart A; 40 CFR part 745, subpart F). When these section 403 rules become effective, lead-based paint hazards in lead paint, dust or soil will need to be disclosed. EPA further notes, however, that under the section 1018 rules, the seller or lessor also must provide the purchaser or lessee any available records or reports “pertaining to” lead-based paint, lead-based paint hazards and/or any lead hazard evaluative reports available to the sellor or lessor (section 1018(a)(1)(B). See 40 CFR 745.107(a)(4). Accordingly, if a seller or lessor has a report showing lead is present in levels that would not constitute a hazard, that report must also be disclosed. Thus, disclosure is required under section 1018 even if dust and soil levels are less than the hazards. EPA notes, however, that with respect only to leases of target housing, disclosure is not required in the limited circumstance where the housing has been found to be lead-based paint free by a certified inspector (24 CFR 35.82; 40 CFR 745.101), although voluntary disclosure of such certifications is encouraged.

Beyond the scope of Title X, these standards will guide the control of lead-based paint hazards in the nation's housing stock.

Although other regulations (e.g., hazard evaluation and control in housing receiving Federal assistance and Federally-owned housing prior to sale) may require property owners to evaluate properties for the presence and/or control of lead hazards, today's action does not contain such requirements. Specific requirements are determined by the particular State, Federal, and local government regulations which mandate actions when health hazards are found in target housing or child-occupied facilities. EPA, however, strongly recommends that property owners or other decision makers take appropriate actions to reduce or eliminate hazards. Finally, the standards provide property owners and other decision makers with the Federal government's best judgement concerning lead dangers in residential paint, dust, and soil.

The standards were established assuming that property owners and other decision makers would identify and control hazards in all three media (i.e., paint, dust, and soil). Failure to take a multimedia approach may not provide adequate protection to children. First, the protectiveness of the standards assumes that all media will be appropriately addressed. Second, failure to address one or more medium leaves children at risk from exposure to lead in media that are not addressed. Third, failure to address one or more media reduces the effectiveness of hazard control actions that are taken due to recontamination of one media from lead in another. Fourth, the Agency believes that soil can be a source of exposure whenever it is accessible for either incidental ingestion or tracking into a home, and that while grass and other coverings may be effective in significantly reducing potential exposures, such coverings must be maintained in order to provide continuing protection.

F. Summary of the Final Rule

1.
Hazardous lead-based paint (§ 745.65(a)).
The hazard standard for lead-based paint, called the “paint lead hazard,” is any of the following:

a. Any lead-based paint on a friction surface that is subject to abrasion and where the lead dust levels on the nearest horizontal surface underneath the friction surface are equal to or greater than the dust hazard levels.

b. Any damaged or otherwise deteriorated lead-based paint on an impact surface that is caused by impact from a related building component.

c. Any chewable lead-based paint surface on which there is evidence of teeth marks.

d. Any other deteriorated lead-based paint in residential buildings or child-occupied facility or on the exterior of any residential building or child-occupied facility.

The purpose of identifying almost all deteriorated lead-based paint as a paint lead hazard is to alert the public to the fact that all deteriorated lead-based paint should be addressed--through use of paint stabilization or interim controls. Something less than abatement and certified personnel, however, would be needed to undertake interim controls or to abate lower levels of deterioration.

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 dust-lead hazard standards are 40 μg/ft
2
for floors based on a weighted average of all wipe samples and 250 μg/ft
2
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/ft
2
for floors, 250 μg/ft
2
for interior window sills, and 400 μg/ft
2
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

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 ft
2
of deteriorated lead-based paint on exterior components with large surface areas, more than 2 ft
2
of deteriorated lead-based paint on interior components with large surface areas, or deteriorated lead based paint on more than 10% of the total surface area of interior or exterior components with small surface areas. Lesser amounts of deteriorated paint were considered
de minimis
levels and were not considered hazards. The proposed standard for a dust lead hazard was the average level of lead in dust that equals or exceeds 50 μg/ft
2
on uncarpeted floors and 250 μg/ft
2
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/ft
2
for uncarpeted floors, 250 μg/ft
2
for interior window sills, and 800 μg/ft
2
for window troughs.

2. Requirements for interpreting the results of a lead-based paint risk assessment sampling for purposes of determining if lead-based paint hazards are present.

3. Changes to the dust and soil sampling locations in the risk assessment work practice standards at 40 CFR 745.227.

4. Work practice standards for the management of soil removed during an abatement; and

5. Amendments to the State and Tribal program authorization requirements under 40 CFR part 745, subpart Q.

B. Summary of Significant Changes from the Proposed Regulation and Other Major Decisions

This section of the preamble briefly presents the major changes between the proposal and final rule. EPA also identifies major provisions of the proposed regulation that remain unchanged in the final rule. Unit II.D. of the preamble presents the Agency's explanation for these decisions.

1.
Dust standards
. The final rule changes the lead-based paint hazard standard for dust, known as the dust-lead hazard, and the standard for dust clearance for floors to 40 μg/ft
2
. 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/ft
2
to 400 μg/ft
2
. In addition, the final rule modifies the method for interpreting composite dust clearance samples. Under the proposed rule, the result of the composite sample would have been compared to the clearance level divided by the number of subsamples in the composite. The final rule requires the result of the composite sample to be compared to the clearance level divided by half the number of subsamples in the composite.

2.
Soil standards
. With respect to the soil standards, there are several changes from the proposed rule. First, EPA is not establishing any distinction between lead-contaminated soil (soil lead “level of concern”) and soil-lead hazards. Instead, EPA is, in the preamble, simply identifying lead-contaminated soil as soil with levels equal to or greater than the soil-lead hazard standards. For purposes of this rule “lead-contaminated soil” is the same as a “lead-based paint hazard” based on soil lead.”

Second, in the final rule EPA is establishing the lead-based paint hazard standard for bare soil, known as the soil-lead hazard standard, to have one hazard level for play areas and another for the remainder of the yard. The proposed rule did not give special attention to play areas and made the hazard determination based on the whole yard only. From the proposed 2,000 ppm for bare soil in the entire yard, EPA is setting a final soil-lead hazard of 400 ppm for bare soil in play areas and an average of 1,200 ppm for bare soil in the non-play area portion of the yard.

3.
Paint standards
. The paint component of the lead-based paint hazard standards is known as the paint-lead hazard. The paint-lead hazard consists of three standards: Deteriorated lead-based paint; lead-based paint on friction and impact surfaces; and lead-based paint on accessible (chewable) surfaces.

a.
Deteriorated paint
. EPA considers that, in general, any deteriorated lead-based paint needs to be addressed and should be considered a paint-lead hazard. Accordingly, in the final rule the Agency does not have a
de minimis
level of deteriorated paint for the paint-lead hazard. Instead, the final rule simply refers to work practice and certification regulations issued by HUD and EPA that apply to dealing with paint-lead hazards. These regulations provide that occupant protection procedures, clearance testing, use of certified personnel or other similar specialized lead hazard control practices and procedures are not required at lesser levels of paint deterioration. These specific levels of deterioration are (i) Two square feet or less of deteriorated lead-based paint per room; (ii) twenty square feet or less of deteriorated exterior lead-based paint; (iii) ten percent of the total surface area on an interior or exterior type of component with a small surface area.

b.
Friction and impact surfaces
. The standard in the final rule for the paint-lead hazard on friction surfaces is lead-based paint that is subject to abrasion where the lead dust levels on the nearest horizontal surface underneath the friction surface are equal to or greater than the lead-dust hazard levels. The paint-lead hazard for impact surfaces is any damaged or otherwise deteriorated paint on an impact surface that is cause by impact from a related building component. No minimum area threshold of paint deterioration applies to friction or impact surfaces. In the proposed rule, EPA did not include a preferred option for these surfaces. The Agency, instead, solicited public comment on a range of options including: Lead-based paint regardless of condition on a friction/impact surface; abraded lead-based paint on a friction/impact surface; and no separate standard.

c.
Surfaces accessible for chewing or mouthing
. The standard for the paint-

lead hazard on accessible surfaces, referred to as “chewable” surfaces in the final rule, is any chewable lead-based paint surface on which there is evidence of teeth marks. No minimum area threshold applies to deteriorated lead-based paint on accessible surfaces. In the proposed rule, EPA did not include a preferred option for these surfaces. The Agency, instead, solicited public comment on a range of options including: Lead-based paint regardless of condition on interior window sills up to 5 feet off the floor; and no separate standard for accessible surfaces. EPA has eliminated the 5-foot requirement.

4.
Requiring certified risk assessors to determine the existence of lead-based paint hazards
. The final rule does not include a requirement that the presence of lead-based paint hazards must be determined by certified risk assessors following the risk assessment work practice standards at 40 CFR 745.227.

C. Explanation of the Agency's Decisions

In this section of the preamble, EPA provides its reasons for choosing the final TSCA section 403 standards for lead-based paint hazards (which includes paint-lead, dust-lead, and soil-lead hazards) and its final determination for what constitutes lead-contaminated dust and residential soil. In addition, EPA provides its reasons for establishing the clearance levels for household dust--measures of dust in lead that will show that hazards have been appropriately cleaned.

The choice of the particular methodologies used to develop each of these standards constitutes another important set of decisions. Hazard levels for dust and soil were developed using an analysis of risk, the potential for risk reduction (considering uncertainties in the data and scientific evidence describing the risks), and the cost of reducing risk. In determining the paint-lead hazard, EPA has decided that any deteriorated lead-based paint would result in adverse health effects, based on information submitted in public comments and other information in the rulemaking record. The Agency has been unable to determine any level of deteriorated lead-based paint that should not be considered a paint-lead hazard.

The general outline of these methodologies is referred to in later sections of this Unit and, where applicable, incorporates into the final rule those decisions made in the preamble to the proposed rule.

1.
Basis for dust and soil standards
. As a preliminary matter, EPA has found, after considering all significant public comments and all other information in the rulemaking record, that the legal interpretations and policy decisions in the preamble to the proposed rule form the basis for the final decisions discussed in this preamble, except as indicated below. EPA hereby incorporates, for purposes of this final rule, the relevant reasoning and analyses from the proposed preamble, as indicated below. Any modifications to the analyses or reasoning from the preamble to the proposed rule will be specifically explained in this preamble, the Reponse to Comment (RTC) document, or other documents in the record, and are supported by the record for the final rule.

a.
Legal basis
. Details of the basic legal structure of Title X and the legal effect of the issuance of regulations under TSCA section 403, including the responsibilities of EPA and HUD, are set forth in the preamble to the proposed rule (63 FR 30306) and need not be repeated here. There EPA provided a detailed discussion of its views at the time of the statutory mandate and the statutory criteria, including the Agency's interpretation of relevant terms and the statutory basis for the Agency's decision to use particular criteria to develop the determination for what constitutes lead-contaminated dust and lead-contaminated soil and the hazard standards for dust, soil and paint at (63 FR at 30311-30315). EPA has modified some of these interpretations and retains others, as discussed below.

EPA needs to define three terms under TSCA section 403, “lead-based paint hazards,” “lead-contaminated dust” and “lead-contaminated soil.” Lead-based paint hazards consist of lead-contaminated paint, lead-contaminated dust and lead-contaminated soil that “would result” in adverse health effects.

Section 401(9) of TSCA provides a definition of lead-based paint, which EPA interprets to be lead-contaminated paint for purposes of this rule. EPA noted that lead-based paint is not, under the statute, a risk-based term, but only a benchmark that identifies material subject to jurisdiction of the authorities of TSCA and Title X. Not all lead-based paint is a hazard, only that paint which EPA determines “would result” in adverse health effects. EPA has determined, as discussed below, that the dust and soil levels designated as lead-based paint hazards are also identified as “lead-contaminated dust” and “lead-contaminated soil.” This equating of dust and soil contamination with “lead-based paint hazards” caused by dust and soil lead represents a change from the reasoning in the preamble to the proposed rule. EPA's reasons for this change are discussed below.

EPA generally refers to the hazards in each of the media as “paint-lead hazards,” “dust-lead hazards” and “soil-lead hazards.”

i.
Decision on contaminated dust and soil
. While section 403 obligates the Agency to identify lead-based paint hazards, lead contaminated dust, and lead-contaminated soil, the legislative history and statutory text are themselves silent on how Congress intended the Agency to differentiate between the standard for soil contamination (the level of lead in soil determined to be hazardous to human health), dust contamination (the level of lead in dust that poses a threat of adverse health effects in pregnant women or young children), and the levels of contaminated dust or soil that constitute a lead-based paint hazard (a condition that would result in adverse human health effects). Further, the terms “lead-contaminated dust” and “lead-contaminated soil” have no significance under either TSCA or Title X except insofar as the level of contaminated dust or soil constitutes a “lead-based paint hazard”.

In the proposed rule EPA considered that, because the statute required the identification of “lead contaminated” dust and soil, the Agency needed to establish separate levels for these terms than for “lead-based paint hazards” resulting from contaminated dust or soil. Furthermore, EPA proposed, based on the statutory language and the structure of the statute, that the determination of whether dust or soil were contaminated required less certainty than whether such dust or soil constituted a hazard. See 63 FR 30311-12. In the preamble to the proposed rule EPA set the “contamination” levels, then called “levels of concern,” at those levels the Agency determined could result in a 1 to 5% probability of an individual child's exceeding a blood lead level of 10 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 soil-lead hazards. Because the contamination levels do not affect other activities under Title X or TSCA Title IV, EPA proposed not to include them in the regulatory language. EPA only proposed to adopt in guidance to accompany the final rule a separate level for lead-contaminated soil of 400

ppm for the entire yard. EPA did not propose to adopt a separate standard for contaminated dust, since it found substantial overlap in its analysis and could not distinguish between dust-lead contamination and dust-lead hazards.

EPA received a significant number of comments criticizing the establishment of these “contamination” levels, particularly for soil, primarily because setting two levels for “contamination” and “hazard” would confuse the public. Other comments claimed EPA had no authority to establish separate contamination levels, as opposed to hazard levels.

While the Agency clearly has authority to establish separate levels for contaminated dust and soil, given the comments, the lack of clear statutory direction, and the lack of significance of the terms in the statutory structure, the Agency has determined not to establish any separate levels for contaminated dust or soil beyond those levels that constitute a lead-based paint hazard. The Agency believes it sufficient for purposes of TSCA and Title X to conclude that, at a minimum, the quantity of lead in dust or soil found to result in conditions that cause exposure to lead that would result in adverse human health effects (i.e., constitutes a lead-based paint hazard) is “lead-contaminated dust” and “lead-contaminated soil,” respectively. Accordingly, for purposes of this regulation, the dust and soil levels designated as lead-based paint hazards are also identified as “lead-contaminated dust” and “lead-contaminated soil”.

ii.
Weight of evidence for dust and soil hazard standards
. EPA's dilemma in determining what constitutes dust-lead and soil-lead hazards is based on the Agency's recognition that any determination of hazard requires a great deal of judgment in the case of lead health risks where, “as a practical matter, all the scientific evidence is uncertain to some degree . . .” (See preamble to the proposed rule at 63 FR 30313.) Making judgments on the science varies to a large extent with respect to three issues: How to determine which blood lead levels are truly hazardous; how to interpret the statutory language “result in adverse human health effects,” when uncertainties exist; and how best to account for uncertainties in the risk analyses that relate environmental lead levels to blood lead levels and the prevalence data that is used in this analysis.

The resolution of these issues, at best, produces a continuum where, at one end, blood and environmental levels exist that everyone would agree constitute a hazard. At the other end, approaching blood lead levels in the general population (averaging lower than 5 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 “lead-based paint hazard,” all persons would act rationally in their own best interests and would permanently eliminate (abate) these hazards before a child is about to become exposed to them. This is the so-called “normative” analysis referred to in the preambles to the proposed and final rule and discussed in detail in the economic analyses and preambles for the proposed and final rules. (EPA's analysis for using this method for determining what constitutes dust and soil hazards is discussed in detail in the preamble to the proposed rule at 30312-15. That analysis is incorporated as the final interpretation of the Agency on this matter and will not be repeated in great detail here. Later in this preamble, EPA responds to the various public comments on its analysis of the appropriate method for determining dust and soil lead-hazards under TSCA section 403.)

Also, identification of lead-based paint hazards under this regulation is sure to have impacts that could be expensive even though the range of expenses is, itself, difficult to resolve because of the uncertainty of individual behavior and the willingness of individuals to accept risks that EPA may identify. Thus, if EPA were to choose standards that are too low, the public could be unable to distinguish between trivial risks at the low levels of lead from the more serious risks at higher levels. This could result in clean up for little to no health benefit, or conversely, it could result in almost no clean up because persons would question the credibility of the “hazard” determination. Thus, they may ignore even those high risk situations that need to be controlled. On the other hand, if the Agency chooses standards that are too high, actual adverse effects could occur at levels below that. EPA's dilemma is to draw this line.

Based on the language of section 403, the purposes of Title X and its legislative history, and basic policy decisions, EPA determined that it was a reasonable exercise of its discretion to draw this line based on consideration of the potential for risk reduction of any action taken (considering uncertainties in the data and the scientific evidence describing the risks) and whether such risk reductions are commensurate with the costs of those actions. This is commonly referred to as cost-benefit balancing. In this rule, EPA used cost-benefit balancing to assist in identifying the hazard standards. This method was useful because available data run through various models showed a range of environmental levels that could be associated with a particular blood-lead level (the surrogate used to approximate risk) and the potential reduction in blood-lead concentration/risk that could result from eliminating or controlling the environmental level. Given this range, EPA used cost-benefit balancing to assist in selecting the specific

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/ft
2
on uncarpeted floors and 250 μg/ft
2
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 lead-contaminated soil and dust, there could be some small mathematical probability that a child could still have a blood-lead level equaling or exceeding 10 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

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/ft
2
. The range for dust loadings on window sills is from near zero to 74 μg/ft
2
.

The performance characteristics analysis yielded the following results. For floors, dust-lead loadings ranged from 50 μg/ft
2
to 400 μg/ft
2
. For interior window sills, dust-lead loadings ranged from 100 μg/ft
2
to 800 μg/ft
2
. 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.,

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/ft
2
, 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/ft
2
, 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/ft
2
correspond to 5% and less probability of blood lead levels exceeding 10 μg/dL. Thus, using the revised model, 40 μg/ft
2
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/ft
2
as the initial candidate level for the dust-lead 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 blood-lead 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 site-specific data to the extent that would be sought when they are applied locally.

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 dust-lead 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 soil-lead 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

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 7A-3 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 dollars
Product 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 dollars
Sum 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 dollars
Accounting 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 dollars
Kakalik 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 dollars
Kakalik 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 Group
1
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)

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/ft
2
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/ft
2
and are slightly higher with floor dust standards of 50 μg/ft
2
as compared to 100 μg/ft
2
. 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/ft
2
with sill = 100 μg/ft
2
and floor = 100 μg/ft
2
with sill = 1,000 μg/ft
2
, 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/ft
2
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/ft
2
for floors and 250 μg/ft
2
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 model-based 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/ft
2
for floors, 1,000 μg/ft
2
for sills) provides significantly less risk reduction relative to cost; and one combination (50 μg/ft
2
for floors, 100 μg/ft
2
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/ft
2
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/ft
2
to $ 61 billion for the proposed 50 μg/ft
2
standard.

EPA reiterates that this normative cost-benefit analysis has been undertaken for comparative purposes

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/ft
2
and 250 μg/ft
2
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/ft
2
because, in its risk analysis, EPA's best estimate was that the post-intervention dust-lead loading would be the lower of the pre-intervention dust-loading or 40 μg/ft
2
. 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/ft
2
because little or no risk reduction would likely to be achieved for homes that had dust-lead loadings at or below 40 μg/ft
2
.

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/ft
2
. Of particular relevance were comments from HUD stating that, in its experience, cleaning to levels below 40 μg/ft
2
was typically achieved as evidenced by its Grantees program. In fact, since the proposal of this rule, HUD has promulgated a 40 μg/ft
2
standard for floors in its 1012/1013 regulations. Since EPA's basis for not considering a standard less than 50 μg/ft
2
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/ft
2
standard is achievable, the Agency is establishing 40 μg/ft
2
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/ft
2
hazard standard. In fact, as compared to the proposed standard of 50 μg/ft
2
with a sill dust standard of 250 μg/ft
2
(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/ft
2
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

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) Lead-in-Dust study and the pre-intervention, evaluation phase of the HUD Lead-Based 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/ft
2
instead of 40 μg/ft
2
). 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 dust-lead 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/ft
2
and 250 μg/ft
2
respectively. This chang

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A01-84. Public record. Not legal advice.