Significant New Uses of Lead

SUMMARY: EPA is exploring the possibility of issuing significant new

use rules (SNURs) for certain uses of elemental lead (Pb) and lead

compounds under section 5(a)(2) of the Toxic Substances Control Act

(TSCA). The SNURs would require persons to notify EPA at least 90 days

before commencing the manufacture, import, or processing of lead and

lead compounds for uses identified by the Agency as significant new

uses. The significant new use notice (SNUN) would provide EPA with the

opportunity to evaluate the intended use and associated activities and

to prevent potentially unreasonable risk of injury to human health and

the environment from occurring. EPA is issuing this ANPR to: (1)

Communicate its intention to regulate significant new uses of elemental

lead and lead compounds; (2) identify components of its proposed

regulatory approach; (3) request comment on issues related to this

approach; and (4) request comment and information on existing uses of

lead that would help support EPA's selection of proposed criteria for

defining significant new uses of lead. The Agency is particularly

concerned with products the use of which may pose unreasonable risks to

children. The information submitted in response to this ANPR will help

EPA design an effective and efficient strategy for regulating

significant new uses of lead.

DATES: Written and electronic comments in response to this ANPR must be

received on or before November 28, 1994.

ADDRESSES: All written data and comments should be submitted in

triplicate to OPPT Document Control Officer (7407), Office of Pollution

Prevention and Toxics, Environmental Protection Agency, Rm. E-G99, 401

M St., SW., Washington, DC 20460. All written data and comments should

be identified by the docket number OPPTS-50618.

Comments and data may also be submitted electronically by any of

three different mechanisms: by sending electronic mail (e-mail) to:

[email protected]; by sending a ``Subscribe'' message to

[email protected] and once subcribed, send your

comments to RIN-2070-AC37; or through the EPA Electronic Bulletin Board

by dialing 202-488-3671, enter selection ``DMAIL,'' user name ``BB--

USER'' or 919-541-4642, enter selection ``MAIL,'' user name ``BB--

USER.'' Comments and data will also be accepted on disks in WordPerfect

in 5.1 file format or ASCII file format. All comments and data in

electronic form should be identified by the docket number OPPTS-50618.

Electronic comments on this ANPR, but not the complete record, may be

viewed or new comments filed online at many Federal Depository

Libraries. Additional information on electronic submissions can be

found in Unit VII. of this document.

Data and comments in written form containing information claimed as

confidential business information (CBI) should be submitted in

triplicate to: OPPT Document Control Officer (7407), Office of

Pollution Prevention and Toxics, Environmental Protection Agency, 401 M

St., SW., Washington, DC 20460, Attention: OPPTS-50618. A sanitized

copy of the comments that can be included in the public docket must be

provided in triplicate to the OPPT Document Control Officer. Further

information on submitting comments containing information claimed as

CBI is provided in Unit VIII. of this document. No CBI should be

submitted through e-mail.

FOR FURTHER INFORMATION CONTACT: For general information contact: Susan

B. Hazen, Director, Environmental Assistance Division (7408), Office of

Pollution Prevention and Toxics, Environmental Protection Agency, 401 M

St., SW., Washington, DC 20460, Telephone: 202-554-1404, TDD: 202-554-

0551. For technical information contact: Jonathan Jacobson, Chemical

Management Division (7404), Office of Pollution Prevention and Toxics,

Environmental Protection Agency, 401 M St., SW., Washington, DC 20460,

Telephone: 202-260-3779, Internet: [email protected].

SUPPLEMENTARY INFORMATION: Reducing human exposure to lead and lead

contamination of the environment continue to be priority issues for

EPA. Exposure to lead can result in a variety of adverse human health

effects in both children and adults. Recent research and scientific

evidence indicate that human health effects (e.g., impaired

neurological development) occur at low exposure levels. Lead

contamination of the environment is causing degradation of habitat and

lead products have been implicated in the death of individual animals

from several species.

In response to these problems, EPA has undertaken a variety of

regulatory, programmatic, and research efforts to evaluate and address

the environmental impacts of lead. Since 1991, Agency activities have

been coordinated through the Strategy for Reducing Lead Exposures. This

strategy includes regulatory and pollution prevention activities, a

lead abatement program for ``in-place'' lead, and a research program.

The promulgation of SNURs for elemental lead and lead compounds is part

of EPA's multi-faceted strategy for reducing unacceptable lead

exposures.

EPA's efforts are designed to reduce exposure to lead by: (1)

Preventing new uses and phasing out current uses of lead that pose

unreasonable risks; (2) controlling lead emissions; (3) managing the

disposal of lead-containing wastes; (4) addressing in-place lead; and

(5) supporting research to improve EPA's ability to assess and reduce

lead-related risks.

I. Authority

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to

determine that a use of a chemical substance is a ``significant new

use.'' The Agency must make this determination by rule after

considering all relevant factors, including those listed in section

5(a)(2). Section 5(a)(2) factors generally relate to the extent to

which a use changes the volume of a chemical's production or the type,

form, magnitude, or duration of exposure to it. Once EPA determines

that a use of a chemical substance is a significant new use, section

5(a)(1)(B) of TSCA requires persons to submit a notice to EPA at least

90 days before they manufacture, import, or process the chemical

substance for that use.

Persons subject to a SNUR would comply with the same notice

requirements and EPA regulatory procedures as submitters of

premanufacture notices (PMNs) under section 5(a)(1)(A) of TSCA. In

particular, these requirements include the information submission

provisions of section 5(b) and (d)(1), the exemptions authorized by

section 5(h)(1), (2), (3), and (5), and the regulations at 40 CFR part

720. The premanufacture notification process provides EPA the

opportunity to review the particular use of the chemical substance and

make a reasonable risk determination prior to the use's commercial

introduction. Following its review, EPA may take regulatory action

under section 5(e), 5(f), 6, or 7 to control the activities for which

it has received a SNUN. If EPA does not take action, section (5)(g) of

TSCA requires EPA to explain in the Federal Register its reasons for

not taking action.

Persons who intend to export a substance identified in a final SNUR

are subject to the export notification provisions of TSCA section

12(b). The regulations that interpret section 12(b) appear at 40 CFR

part 707. Persons who import a substance identified in a final SNUR

must certify that they are in compliance with TSCA, which includes the

SNUR requirements. The EPA import certification requirements appear at

40 CFR part 707.

II. Uses of Lead

Lead is a soft, gray metallic element mined from rock and found in

its natural state all over the world. It is virtually indestructible

and non-biodegradable. Its malleability, low melting point, ease of

processing, abundance, low cost, density, lubricant properties, and

durability give it good functional value.

In 1992, the U.S. Bureau of Mines reported that U.S. industries

consumed over 1.24 million tons of lead. Of this quantity, nearly 81

percent was used to manufacture storage batteries and 5 percent was

used in the ammunition industry. Other uses include: Glass and

ceramics; lead chemical products; cable coverings; lead sheet; lead

solder; casting lead; pigments; pipes, traps, and other extruded

products; brass and bronze; other metal products; heat stabilizers; and

bearing metals. Manufacturers use lead in its elemental form, in

compounds including lead oxides and lead chromate, and in alloys (e.g.,

brass and solder).

III. Human Health Effects

Exposure to lead can produce a spectrum of human health effects

across a wide range of exposure levels. Recent studies indicate that

these toxic effects may occur at exposure levels considerably lower

than previously recognized. Accordingly, the Centers for Disease

Control and Prevention (CDC) has established the threshold of concern

for blood lead (PbB), the most common index of lead exposure, at 10

g/dL.

Young children and fetuses are especially vulnerable to lead: the

nervous systems are developing and lead is absorbed into the blood

stream more easily than in adults. High PbB levels (>40-60 g/

dL) in children are associated with anemia, mental retardation, and

encephalopathy. At extremely high levels (>100 g/dL), death

may occur. There is also a concern that high lead exposure might play a

role in spontaneous abortions. At lower exposure levels, lead has been

linked to impaired cognitive performance, delayed neurological and

physical development, decreased birth weight, and interference with

heme synthesis and Vitamin D metabolism.

Recent research indicates that deficits in IQ and other measures of

cognitive functions have been associated with PbB levels of 10

g/dL (Bellinger, D.C., Stiles, K.M., and Needleman, H.L.;

``Low-Level Lead Exposure, Intelligence and Academic Achievement: A

Long-Term Follow-up Study''; Pediatrics; 1992; vol. 90; pp. 855-861).

EPA, in its Air Quality Criteria for Lead, Volumes I-IV and Addendum

(USEPA, 1986) and its Air Quality Criteria for Lead, Supplement to 1986

Addendum (USEPA, 1990), has identified the following relationships

between lead exposure and human health:

1. Deficits in mental indices have been found in infants with

maternal or umbilical cord PbB levels as low as 6-7 g/dL.

2. Low birth weights and decreased gestation age, factors that may

influence early neurological development have been associated with

infants born to women with PbB levels above 12-14 g/dL and

possibly as low as 7 g/dL.

3. Early childhood growth reductions have been associated with PbB

levels from 5-35 g/dL.

In its study Measuring Lead Exposure in Infants, Children, and

Other Sensitive Populations, the National Academy of Sciences

documented a similar range of effects (NAS, 1993). The Academy noted

that PbB concentrations around 10 g/dL are associated with

disturbances in early physical and mental growth and in later

intellectual functioning and academic achievement.

Although Federal government interest in lead poisoning has

primarily focused on children, there is substantial evidence that lead

exposures can produce adverse health effects in adults. Of great

concern is evidence that elevated PbB levels have been associated with

slight increases in blood pressure. Because lead is stored in bone, it

may be mobilized during periods of stress or greater metabolic demands

for calcium (e.g., pregnancy).

IV. Environmental Effects

Lead is one of the most common toxic substances found in large and

small animals. Lead poisoning is the most frequently diagnosed

toxicological problem in veterinary medicine; its occurrence has been

reported in all domestic species and in several species of zoo animals.

Lead poisoning has also affected many major species of waterfowl in

North America and has been reported in many birds elsewhere in the

world. Sources of these exposures have typically included lead wastes,

lead paint, spent lead shot, fishing sinkers, and contaminated forage

near smelters and roadways.

Laboratory and field data show that at high concentrations, lead

can affect certain plants and inhibit photosynthesis, reduce growth,

and alter species composition. Other studies indicate that high lead

concentrations alter the composition of soil microbial communities and

inhibit invertebrate activity resulting in delayed decomposition of

organic matter, reduced nutrient supply, and altered soil properties,

such as lower organic content.

Lead is toxic to many phyla of aquatic biota. Water lead

concentrations as low as 19 to 30 g/L have been associated

with increased mortality and impaired reproduction in aquatic

invertebrates. Aquatic vertebrates (e.g., fish) appear to be even more

sensitive. Studies have shown that freshwater aquatic organisms are

more sensitive to lead in soft than hard water.

V. Controlling Lead Exposure

Over the last two decades EPA has taken a number of actions to

control exposure to lead. Most notable of these actions has been the

virtual removal of lead from gasoline. As a result of this action and

the phase-out of lead solder in food cans by domestic manufacturers, it

is estimated that the average PbB level in children has declined by 75

percent (from about 17 g/dL to 4 g/dL) over the past

15 years.

Despite this progress, several factors have prompted EPA to

identify other sources of on-going lead exposure, especially exposure

among children, and initiate additional actions. First, the level of

concern at which lead may adversely affect human health continues to

decrease. CDC revised its level of concern from 25 g/dL to 10

g/dL in 1990. Second, nearly nine percent of children continue

to have PbB levels in excess of CDC's level of concern, with a higher

incidence of elevated PbB reported for minorities living in urban areas

(CDC, 1994). Third, other sources of lead (e.g., lead-based paint and

drinking water) are the primary sources of exposure for segments of the

population.

To coordinate EPA's lead activities, the Agency published the

Strategy for Reducing Lead Exposures in February 1991, the goal of

which is to reduce lead exposures to the fullest extent practicable.

Two objectives have been used to set program priorities and gauge

program success: (1) Reduce significantly the incidence of PbB levels

above 10 g/dL in children while taking into account the

associated costs and benefits; and (2) reduce significantly, through

voluntary and mandatory actions, unacceptable lead exposures that are

anticipated to pose risks to children, the general public, or the

environment. EPA plans to achieve the strategy's goal and objectives

through implementation of research, abatement, and regulatory and

pollution prevention programs.

A. Research Program

The purposes of the research program are to: (1) Locate and assess,

in terms of geography and media, the most serious lead risks; and (2)

develop methods and tools to reduce these risks cost-effectively.

Examples of accomplishments and on-going efforts include evaluation of

low-cost lead-based paint (LBP) abatement techniques, development of

LBP abatement sampling techniques and protocols, studies to analyze the

effectiveness of corrosion control technologies in small public water

supply systems to reduce lead levels, and continued development and

review of the Integrated Environmental Uptake/Biokinetic (UBK) Model to

assess the relationship between environmental lead exposure and PbB

levels.

B. Abatement Program

1. Lead-based paint. EPA's abatement program for ``in-place'' lead

focuses on two major sources of exposure: LBP and lead-contaminated

soil. LBP is the most serious source of children's lead exposure. The

Agency for Toxic Substances and Disease Registry (ATSDR) estimates that

12 million children are exposed to LBP at home and that nearly 6

million are exposed in homes with the highest concentrations of lead

(houses built prior to 1940). Under a Memorandum of Understanding, EPA

works closely with the U.S. Department of Housing and Urban Development

(HUD) to address the LBP problem. EPA's efforts in this area have

intensified with the enactment of Title X, ``The Residential Lead-Based

Paint Hazard Reduction Act of 1992'' (the Act). Subtitle B of the Act,

which amended TSCA by creating Title IV, provides for a comprehensive

national approach to dealing with LBP in the nation's housing stock.

One of the purposes of the Act is to reorient the Federal program from

abatement of all residential LBP to abatement and in-place management

of priority LBP hazards.

To date, EPA's LBP program has successfully implemented several

initiatives. The Agency has established regional training and

information centers and implemented a nationwide public outreach and

education campaign. The outreach and education campaign consists of the

National Lead Information Center, which operates the Lead Hotline and

the Lead Clearinghouse. In addition, the National Lead Poisoning

Prevention Education Campaign disseminates important information on

residential LBP hazards through radio and television public service

announcements.

The Act also directs EPA to develop several regulations designed to

address residential LBP exposures. Under TSCA section 402(a)(1), EPA is

developing training and certification requirements for individuals and

contractors engaged in LBP activities (e.g., risk assessment,

inspection, and abatement). These regulations will establish standards

for performing LBP activities. This rulemaking also includes procedures

for State and Indian Tribe program authorization under TSCA section

404(a) and a Model State Program under TSCA section 404(d). EPA issued

proposed regulations under TSCA sections 402(a)(1), 404(a), and 404(d)

in the Federal Register of September 2, 1994 (59 FR 45872).

Under TSCA section 403, EPA is developing health-based standards

for identifying lead-based paint hazards, lead-contaminated dust, and

lead-contaminated soil, and on July 14, 1994, issued guidance on this

subject. EPA is developing regulations under TSCA section 406 and

section 1018 of the Act requiring the disclosure of potential LBP

hazards prior to renovation of target housing and the disclosure of

known LBP and LBP hazards prior to the sale or lease of target

housing.1 The Notice of Proposed Rulemaking for TSCA section 406

was published on March 9, 1994 (59 FR 11108). In conjunction with this

rulemaking, the Agency made a pamphlet on LBP hazards available to the

public for review and comment (March 9, 1994; 59 FR 11119). EPA expects

to issue a proposed rule under section 1018 of the Act later in 1994.

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\T\arget housing is defined by section 1004 of Title X to be

``any housing constructed prior to 1978, except housing for the

elderly or persons with disabilities (unless any child who is less

than 6 years of age resides or is expected to reside in such housing

for the elderly or persons with disabilities) or any 0-bedroom

dwelling. In the case of jurisdictions which banned the sale or use

of lead-based paint prior to 1978, the Secretary [of Housing and

Urban Development], at the Secretary's discretion, may designate an

earlier date.''

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Under TSCA section 405(b), EPA has established the National Lead

Laboratory Accreditation Program (NLLAP) and developed protocols,

criteria, and minimum performance standards for laboratories that

analyze paint chip, dust, and soil samples for lead. The purpose of

this program is to ensure that reliable laboratory services are

available to support lead hazard detection and abatement activities.

The Agency, in the first phase of the NLLAP program, is publishing

proficiency test results for laboratories on a state-by-state basis. To

implement the second phase of the program, EPA has executed Memoranda

of Understanding with the American Industrial Hygiene Association

(memorandum from Scott McMoran, USEPA to Gordon Banks, AIHA, December

10, 1993) and the American Association for Laboratory Accreditation

(memorandum from Scott McMoran, USEPA to John Locke, AALA, December 1,

1993) establishing these institutions as laboratory accrediting

organizations. The NLLAP program will recognize laboratories accredited

by these organizations as capable of analyzing paint chip, dust, and

soil samples for lead.

2. Lead-contaminated soil. The other major area of focus for EPA's

abatement program for ``in-place'' lead is lead-contaminated soil. The

Agency has completed a review draft of the Urban Soil Lead Abatement

Demonstration Project (Three City Study) (USEPA, 1993). In addition,

the Agency issued revised guidance on soil lead screening levels for

Comprehensive Environmental Response, Compensation, and Liability Act

and Resource Conservation and Recovery Act (RCRA) sites on July 14,

1994.

The Three City Study, authorized by section 111(a)(6) of the

Superfund Amendments and Reauthorization Act (SARA), evaluated the

effectiveness of soil lead abatement for reducing PbB levels in inner

city children. The project, which analyzed data from Baltimore, Boston,

and Cincinnati, demonstrated a clear relationship between environmental

lead and PbB. Analysis of the data (peer review to be completed in

1994) indicates that lead in dust and paint were major contributors to

elevated PbB levels in children and that PbB levels responded to

remedial activity. Furthermore, analytical results from the three

cities suggest that strategies to reduce overall lead exposure at a

site and protect human health need to consider an array of sources

including lead in soil, dust, and paint.

C. Regulatory and Pollution Prevention Program

The third component of EPA's lead strategy is the regulatory and

pollution prevention program. This program, which primarily focuses on

existing and new uses and releases of lead, addresses lead exposures

that are amenable to regulatory control or, in some cases, voluntary

measures. These controls include waste management requirements,

emissions restrictions, and limits on lead in products. Under its lead

regulatory and pollution prevention program, EPA has completed a major

rulemaking and initiated several other important actions.

The Agency published final regulations, promulgating maximum

contaminant level goals and national primary drinking water regulations

for controlling lead and copper in drinking water (40 CFR parts 141 and

142) on June 7, 1991 (56 FR 26460). These regulations established a

maximum contaminant level goal at 0 g/l for lead and an action

level of 15 g/l for lead. Public water supply systems failing

to meet the action level based on sampling methods prescribed in the

rule must initiate treatment actions that may include corrosion

control, source water treatment, lead service line replacement, and

public education. To date, EPA has received sampling data reports from

three rounds of sampling: Round one covered large public water supply

systems; round two covered large and medium-sized systems; and round

three covered medium and small systems.

In an action to protect wildlife, EPA proposed regulations under

section 6(a) of TSCA, limiting the manufacture, processing, and

distribution in commerce in the United States, of certain size lead

fishing sinkers on March 9, 1994 (59 FR 11122). Granting a section 21

petition by the Environmental Defense Fund, EPA proposed this

regulatory action in response to information submitted in the petition

which indicated that common loons, trumpeter swans, and birds from

other avian species had died of lead poisoning after ingesting lead

fishing sinkers. This proposed rulemaking also includes sinkers

containing zinc because studies and other information obtained by EPA

suggests that zinc adversely affects waterbirds and can cause mortality

in avian species.

The Agency's regulatory efforts are complemented by initiatives to

achieve voluntary compliance with lead exposure reduction goals. For

example, EPA is currently participating in efforts by National

Sanitation Foundation International to develop a voluntary lead

leaching standard for kitchen, bar, and lavatory faucets. The objective

of this standard is to reduce the quantity of lead that leaches from

brass faucets. Products that meet the standard based on test samples

and analysis would be certified and appropriately labeled, indicating

to consumers that the product contributes less lead to drinking and

cooking water than faucets that fail to meet the certification

requirements.

VI. Review and Control of New Uses of Lead

A. Rationale

To date, EPA's programmatic efforts have focused on existing uses

of lead, because there is substantial evidence that exposure to lead

has adverse human health and environmental impacts. The Agency,

however, is also concerned about new uses of lead, because they may

result in new or increased exposures which may present an unreasonable

risk of injury to human health and the environment. New or increased

exposure to lead may arise from: (1) Increases in the volume of lead

consumed; (2) increases in the concentration of lead in products; (3)

new products containing lead; and (4) changes in product design that

increase the amount of lead released from a product.

EPA believes that its concern about new uses is justified in light

of lead's physical properties and low cost, attributes which make it an

attractive raw material for a broad variety of commercial and consumer

products. Consequently, the Agency believes that the regulation of

existing uses alone may not be sufficient to reduce lead exposures to

the greatest extent practicable. EPA should also evaluate and, if

necessary, regulate new uses of lead before opportunities for exposure

occur. The Agency further believes that addressing risks prior to

commercial use is more effective than responding to exposures and risks

after the use is introduced commercially. Because children are

especially vulnerable to the impacts of lead, EPA is particularly

concerned about new uses that could present risks to children.

Consistent with the Agency's overall lead risk reduction program, EPA

is also seeking to address risks to adults and the environment from new

uses of lead. The Agency, therefore, is exploring the possibility of

issuing significant new use rules for certain uses of elemental lead

and lead compounds under section 5(a) of TSCA.

B. The SNUR Process

Section 5(a) of TSCA provides EPA with the authority to screen new

uses of a chemical substance to determine whether these uses should be

regulated. This screening function is accomplished through the SNUR

process. EPA may issue a SNUR for a chemical substance after

considering relevant factors, including: (1) The projected volume of

manufacturing and processing of a chemical substance; (2) the extent to

which a use changes the type or form of human or environmental exposure

to a chemical substance; (3) the extent to which a use increases the

magnitude and duration of human or environmental exposure to a chemical

substance; and (4) the reasonably anticipated manner and methods of

manufacturing, processing, distribution in commerce, and disposal of a

chemical substance.

Having considered all the relevant factors, EPA can then issue a

SNUR that identifies the chemical substance and specifies one or more

uses as significant new uses. EPA also has the option to publish a SNUR

that defines any use meeting specified criteria as a significant new

use. Under a third option, EPA may list all past and existing uses of

the substance and define any use not on that list as a significant new

use.

After EPA promulgates a SNUR for a chemical substance, TSCA

requires that a SNUN be submitted to the Administrator at least 90 days

before the start of manufacturing or processing of the significant new

use(s). Based on the information provided in the SNUN and other

relevant data submitted, the Agency will evaluate the risk that the use

presents to human health and the environment. EPA can, for good cause,

extend the review period for a maximum of 90 days.

If, based on its review, the Agency determines that the significant

new use may present an unreasonable risk of injury to human health or

the environment but lacks the information necessary to make a

definitive finding, it can issue an order to prohibit or limit the

manufacturing, processing, or distribution in commerce of the use while

it continues its risk evaluation. Once EPA has made its risk finding,

it can either: (1) Take long-term action to prohibit or limit the

manufacturing, processing, or distribution in commerce of the use if

the use presents or will present unreasonable risk of injury to human

health and the environmentm, or (2) take no action if it finds that

there is no unreasonable risk. When making a determination of

unreasonable risk, EPA considers the risks of the use to human health

and the environment, the benefits of the use, the availability of

substitutes, and the economic consequences of any limits on the use.

In short, section 5 of TSCA gives EPA the authority to promulgate a

SNUR based on factors related to exposure and volume. A SNUR requires

notification of the significant new use(s). Following notification, the

Agency evaluates the risk of the use(s) to determine whether it should

limit or prohibit the use(s). EPA solicits comment on the effectiveness

of using this approach for lead, as well as alternative approaches to

protect human health and the environment from lead exposures.

C. Formulating an Approach for Lead

To date, EPA has promulgated SNURs for substances where existing

use is limited to a few applications and products. These SNURs

typically identify all existing uses of the substance that is the

subject of the SNUR. Lead, however, is used in hundreds of products and

processes across many industries, due to its physical properties and

low cost. The widespread use of lead makes the complete identification

of all existing uses of lead extremely difficult. The traditional

approach of first identifying all existing uses of a chemical

substance, therefore, may not be appropriate for development of a lead

SNUR.

To regulate new uses of lead in a sensible and protective manner,

EPA intends to establish an alternative approach that can be used to

identify significant new uses. This approach consists of two

components: a targeting strategy and criteria for defining significant

new uses.

1. Targeting strategy. The widespread use of lead in commerce has

prompted EPA to develop a strategy that targets new lead uses where

exposure to lead could reasonably be expected to occur as a result of

the designed or anticipated use of the product. For example, the Agency

would be concerned about a new use of lead in a product where lead

could be inadvertently ingested by children (e.g., use of lead-based

artists paints in home studios contributing lead to household dust).

The strategy also targets new uses of lead that could result in adult

and environmental exposure (e.g., heated lead solder for household

electrical repairs that could produce inhalable vapors, spent lead shot

that could contaminate habitat adjacent to shooting ranges). In

contrast, EPA does not currently plan to focus on uses where human and/

or environmental exposure would be less likely to occur (e.g., new

circuit boards used in computers and other electronics products, solder

designed for industrial use in the electronics industry, batteries).

The Agency believes that using exposure to target new uses of lead

is an appropriate tool and consistent with the SNUR authority under

section 5 of TSCA. If, in response to a SNUR that EPA promulgates for

specific lead uses, the Agency receives a SNUN, section 5 requires EPA

to determine if further regulatory action is warranted by assessing

whether the use presents or will present an unreasonable risk of injury

to human health or the environment. By using exposure as the criterion

for identifying new uses that would be subject to a SNUR, EPA intends

to limit the SNUR and its notification requirements to those new uses

where exposure is likely and thus have the potential to present

unreasonable risk. Furthermore, this targeting strategy would eliminate

from the requirements new uses where exposure is less likely and the

potential for unreasonable risk may not exist.

Currently, EPA also does not plan to focus on classes of uses where

other types of regulatory controls may be more appropriate than the

SNUR approach or where existing controls are sufficient. In many

industries, for example, lead compounds may be used during new or

modified manufacturing processes (changes in manufacturing processes

can be a factor in defining a significant new use), possibly resulting

in occupational exposures. Similarly, improperly managed disposal of

lead-containing products could result in exposure through releases to

groundwater (landfilling) or the air (incineration). Although EPA is

concerned about such exposures, the Agency believes that other

regulatory mechanisms (e.g., Occupational Safety and Health Act, Clean

Air Act, and RCRA authorities) are available, and in some cases in

place, to address these problems.

Other uses of lead are exempt from regulation as ``chemical

substances'' by EPA under section 3(2)(B) of TSCA. For example,

exposure to lead through contamination of food and water from

crystalware, ceramicware, and other housewares is regulated by the Food

and Drug Administration (FDA) under authorities granted by the Federal

Food, Drug, and Cosmetic Act and other statutes. The FDA, using its

authorities, has established action levels for lead in ceramic

foodware, including flatware, holloware, cups, mugs, and pitchers. The

FDA has also issued a public advisory on the storage of alcoholic

beverages in crystalware, provided enforcement guidance for lead in

wine, and has proposed a total ban on the use of tin-coated lead

capsules on wine bottles.

EPA is currently examining five priority classes of use for

identification of possible candidates for lead SNURs. Each class is

defined in terms of a distinct exposure and/or environmental release

scenario. These classes reflect the Agency's focus on health risks to

children that may result from lead exposure.

The five use classes are:

1. Products used in water conveyance systems that come in contact

with drinking water. The Agency has substantial evidence that lead

leaches from components of water distribution systems and household

plumbing (e.g., fixtures, fittings, solder, valves, pumps, meters, and

tanks).

2. Products commonly used in and/or around the home where ordinary

use (e.g., manipulation, grinding, sanding, heating) could result in

release of lead to the residential environment. For example, the use of

products such as home hobbyist supplies may contribute lead to

household dust; lead vapors from products that are designed to be

heated could be inhaled.

3. Products that could be mouthed by children where the lead-

containing component in the product is reasonably accessible to

children. Children could ingest lead by mouthing the lead-containing

component (e.g., plastic toys where lead is used as a pigment or

stabilizer and textiles with lead-based dyes).

4. Products that can release lead to the environment through

exposure to weathering elements during use. Lead could be released

through leaching or through deterioration of the product, contaminating

dust and soil (e.g., sheet lead for roofing, lead caulk, traffic

paint).

5. Products intended for non-residential (e.g. recreational,

transportation, commercial, and industrial) use, where use necessarily

results in uncontrolled release of lead to the environment. Examples

include lead-containing products where use involves: (1) Combustion

such as motor fuel additives, resulting in deposition of lead in the

environment and (2) dispersal of the product in the environment such as

fishing sinkers and ammunition containing lead shot.

For each of these five use classes, the following Table 1 provides

examples of both the uses and the lead compounds or elemental forms of

lead.

Table 1.--Illustrative Uses of Lead

------------------------------------------------------------------------

Lead Compounds/Forms

Use Class Uses of Lead

------------------------------------------------------------------------

Products used in water plumbing fixtures and cast brass, wrought

conveyance systems fittings, joints, brass, lead solder

that come in contact seals, solder, meters,

with drinking water pumps, valves, tanks

Products commonly used stained glass, gold lead came, lead

in and around the home pencil, mosaic gold, iodide, lead oxides,

where ordinary use photographic lead bromide, lead

could result in chemicals, water color fluoride, chromic

release of lead to the pigments, lead solder acid, lead

residential for home repairs and biscarbinato, lead

environment home hobbyist use solder

Products that could be plastic toys, textile lead oxides, lead

mouthed by children dyes, lead toy nitrates, lead

where the lead- soldiers, toys painted acetate, tribasic

containing component with lead-based paint lead sulfate, dibasic

in the product is lead stearate, lead

reasonably accessible dichloride

to children

Products that can roofing, flashing, terne metal, lead

release lead to the siding, gutters, sheet, caulking lead,

environment through eaves, seams, paint/ lead solder, lead

exposure to weathering varnish driers, oxide, lead salts,

elements during use industrial paint lead arsenate, lead

pigments, traffic chromate

paint

Products intended for motor fuel (aviation tetra methyl,

nonresidential (e.g. gasoline, racing car tetraethyl,

recreational, fuel) additives, motor triethylmethyl,

transportation, fuel odor modifier, diethyl, dimethyl,

commercial, fishing sinkers, lead plumbate, disodium,

industrial) use where shot for ammunition lead weight, lead

use necessarily shot, lead styphnate

results in

uncontrolled release

to the environment

------------------------------------------------------------------------

The purpose of Table 1 is to provide further clarification and

understanding of these five use classes. Specific uses included in

Table 1 are presented as illustrative examples and are not intended to

represent an exhaustive list. Furthermore, these uses may be existing

uses that would not be subject to the SNUR, depending on the final

definition of ``significant new uses.''

Given the importance of this targeting scheme in regulating new

uses of lead, the Agency is seeking comment on this approach.

Specifically, EPA would like commenters to address the following

issues: (1) The appropriateness of using the targeting approach

described above to design lead SNURs, (2) whether the definition of any

of the five use classes is particularly unclear with respect to the

types of uses or products that might be covered, (3) whether any use

classes listed in Table 1 should not be included in the targeting

strategy and why, and (4) whether any use classes not listed in Table 1

should be included in the targeting strategy and why. EPA is

particularly interested in relevant data that commenters may possess

which suggest that SNURs are or are not appropriate for specific use

classes.

2. Criteria for identifying significant new uses. The second

element of EPA's approach for regulating new uses of lead is criteria

for defining significant new uses of lead. These criteria may include

the development of a new product/use (i.e., product model or line),

change in concentration of lead in a product/use, change in surface

area and other factors that affect the amount of lead released from a

product, and/or change in total volume of lead for a product/use.

Because lead is used in a broad range of products involving numerous

industries, it is likely that the Agency will develop criteria that are

specific to particular products/uses rather than one set of criteria

that would be applied uniformly.

When selecting criteria, EPA will endeavor not to define, as

significant new uses, products or processes that have been developed

specifically to reduce lead exposures. EPA does not wish and does not

intend that any SNUR for lead impede innovations that would reduce

risks to human health and the environment.

To aid in developing these criteria, EPA plans to establish a

baseline inventory of existing uses in the five use classes identified

in Table 1. The baseline inventory will include at least the following

data elements for each identified product/use: Product/use

identification, product/use description; lead compound (and CAS number)

or form of elemental lead; median lead concentration; range of lead

concentration; other design factors associated with the level of lead

released from the product; the frequency with which the design of the

use/product changes; and total volume of lead consumed annually for the

product/use. These data will serve several purposes. First, they will

enable EPA to identify existing uses of lead. Only significant new uses

will be subject to regulation under section 5 of TSCA. Second, these

data will improve the Agency's understanding of existing uses and help

EPA select appropriate criteria for effectively identifying and

controlling significant new uses of lead.

The Agency invites commenters to submit information of the type

described in the preceding paragraph for any lead-containing product/

use belonging to one of the five priority use classes identified in

Table 1. For purposes of this Notice, EPA defines a lead-containing

use/product as a use/product where lead is intentionally introduced at

any stage of manufacturing or processing. EPA is not currently

examining uses/products that contain lead merely as an inadvertent

contaminant. EPA is also interested in data that commenters may possess

on human and environmental exposure, bioavailability, and risks

associated with any such products or uses. Although the Agency does not

normally consider the costs and/or availability of substitutes when

defining new uses for a SNUR, commenters with this kind of information

are welcome to submit the information if they feel that this

information might be useful to the Agency. Data provided by commenters

will help the Agency to compile a baseline inventory of existing lead-

containing products and uses and will help in the selection of criteria

for defining significant new uses of lead.

Currently, EPA is not interested in receiving information for uses/

products that are not described by any of the five priority class

definitions unless the use/product relates to an additional use class

that the commenter believes EPA should consider when developing a SNUR.

Commenters who are uncertain (1) if a specific use/product fits into

any of the five classes and/or (2) about the type of use/product data

that EPA would like commenters to submit should address their questions

to the technical contact listed under ``FOR FURTHER INFORMATION

CONTACT'' in this document.

VII. Rulemaking Record and Electronic Filing of Comments

A record has been established for this ANPR under docket number

``OPPTS-50618'' (including comments and data submitted electronically

as described below). A public version of this record, including

printed, paper versions of electronic comments, which does not include

any information claimed as CBI (see Unit VIII. of this document), is

available for inspection from noon to 4 p.m., Monday through Friday,

excluding legal holidays. The public record is located in the TSCA

Nonconfidential Information Center (NCIC) (also known as the TSCA

Public Docket Office), Rm. NE-B607, 401 M St., SW., Washington, DC

20460.

As part of an interagency ``streamlining'' initiative, EPA is

experimenting with submission of public comments on selected rulemaking

actions electronically through the Internet in addition to accepting

comments in traditional written form. This ANPR is one of the first

rulemaking actions selected by EPA for this experiment. From the

experiment, EPA will learn how electronic commenting works, and any

problems that arise can be addressed before EPA adopts electronic

commenting more broadly in its rulemaking activities. Electronic

commenting through posting to the EPA Bulletin Board or through the

Internet using the ListServe function raise some novel issues that are

discussed below in this Unit.

To submit electronic comments, persons can either ``subscribe'' to

the Internet ListServe application or ``post'' comments to the EPA

Bulletin Board. To ``Subscribe'' to the Internet ListServe application

for this ANPR, send an e-mail message to:

[email protected] that says ``Subscribe RIN-2070-AC37

.'' Once you are subscribed to the ListServe,

comments should be sent to:

RIN-2070-AC[email protected].

For online viewing of submissions and posting of comments, the

public access EPA Bulletin Board is also available by dialing 202-488-

3671, enter selection ``DMAIL,'' user name ``BB--USER'' or 919-541-

4642, enter selection ``MAIL,'' user name ``BB--USER.'' When dialing

the EPA Bulletin Board type at the opening message. When the

``Notes>'' prompt appears, type ``open RIN-2070-AC37'' to access the

posted messages for this document. To get a listing of all files, type

``dir/all'' at the prompt line. Electronic comments can also be sent

directly to EPA at:

[email protected]

To obtain further information on the electronic comment process, or

on submitting comments on this ANPR electronically through the EPA

Bulletin Board or the Internet ListServe, please contact John A.

Richards (Telephone: 202-260-2253; FAX: 202-260-3884; Internet:

[email protected]).

Persons who comment on this ANPR, and those who view comments

electronically, should be aware that this experimental electronic

commenting is administered on a completely public system. Therefore,

any personal information included in comments and the electronic mail

addresses of those who make comments electronically are automatically

available to anyone else who views the comments. Similarly, since all

electronic comments are available to all users, commenters should not

submit electronically any information which they believe to be CBI.

Such information should be submitted only directly to EPA in writing as

described in Unit VIII. of this document.

Commenters and others outside EPA may chose to comment on the

comments submitted by others using the RIN-2070-AC37 ListServe or the

EPA Bulletin Board. If they do so, those comments as well will become

part of EPA's record for this rulemaking. Persons outside EPA wishing

to discuss comments with commenters or otherwise communicate with

commenters but not have those discussions or communications sent to EPA

and included in the EPA rulemaking record should conduct those

discussions and communications outside the RIN-2070-AC37 ListServe or

the EPA Bulletin Board.

The official record for this rulemaking, as well as the public

version, as described above will be kept in paper form. Accordingly,

EPA will transfer all comments received electronically in the RIN-2070-

AC37 ListServe or the EPA Bulletin Board, in accordance with the

instructions for electronic submission, into printed, paper form as

they are received and will place the paper copies in the official

rulemaking record which will also include all comments submitted

directly in writing. All the electronic comments will be available to

everyone who obtains access to the RIN-2070-AC37 ListServe or the EPA

Bulletin Board; however, the official rulemaking record is the paper

record maintained at the address in ``ADDRESSES'' at the beginning of

this document. (Comments submitted only in written form will not be

transferred into electronic form and thus may be accessed only by

reviewing them in the TSCA Nonconfidential Information Center as

described above.)

Because the electronic comment process is still experimental, EPA

cannot guarantee that all electronic comments will be accurately

converted to printed, paper form. If EPA becomes aware, in transferring

an electronic comment to printed, paper form, of a problem or error

that results in an obviously garbled comment, EPA will attempt to

contact the comment submitter and advise the submitter to resubmit the

comment either in electronic or written form. Some commenters may

choose to submit identical comments in both electronic and written form

to ensure accuracy. In that case, EPA requests that commenters clearly

note in both the electronic and written submissions that the comments

are duplicated in the other medium. This will assist EPA in processing

and filing the comments in the rulemaking record.

As with ordinary written comments, EPA will not attempt to verify

the identities of electronic commenters nor to review the accuracy of

electronic comments. EPA will take such commenters and comments at face

value. Electronic and written comments will be placed in the rulemaking

record without any editing or change by EPA except to the extent

changes occur in the process of converting electronic comments to

printed, paper form.

If it chooses to respond officially to electronic comments on this

ANPR, EPA will do so either in a notice in the Federal Register or in a

response to comments document placed in the rulemaking record for this

ANPR. EPA will not respond to commenters electronically other than to

seek clarification of electronic comments that may be garbled in

transmission or conversion to printed, paper form as discussed above.

Any communications from EPA employees to electronic commenters, other

than those described in this paragraph, either through Internet or

otherwise are not official responses from EPA.

VIII. Confidential Business Information

A person may assert a claim of confidentiality for any information,

including all or portions of written comments or data, submitted to EPA

in connection with this advanced notice of proposed rulemaking.

Information claimed as confidential should not be submitted

electronically as described in Unit VII. of this document. Any person

who submits a comment or data subject to a claim of confidentiality

must also submit a nonconfidential version. Any claim of

confidentiality must accompany the information when it is submitted to

EPA. Persons must mark information claimed as confidential by circling,

bracketing, or underlining it, and marking it with ``CONFIDENTIAL'' or

some other appropriate designation. EPA will disclose information

subject to a claim of confidentiality only to the extent permitted by

section 14 of TSCA and 40 CFR part 2, subpart B. If a person does not

assert a claim of confidentiality for information at the time it is

submitted to EPA, EPA may make the information public without further

notice to that person. Any information submitted electronically as

described in Unit VII. will be available to the public immediately

without restriction.

IX. Executive Order 12866

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the

Agency must determine whether the regulatory action is ``significant''

and therefore subject to review by the Office of Management and Budget

(OMB) and the requirements of the Executive Order. Under section 3(f),

the order defines a ``significant regulatory action'' as an action that

is likely to result in a rule: (1) Having an annual effect on the

economy of $100 million or more, or adversely and materially affecting

a sector of the economy, productivity, competition, jobs, the

environment, public health or safety, or State, local or tribal

governments or communities (also referred to as ``economically

significant''); (2) creating serious inconsistency or otherwise

interfering with an action taken or planned by another agency; (3)

materially altering the budgetary impacts of entitlement, grants, user

fees, or loan programs or the rights and obligations of recipients

thereof; or (4) raising novel legal or policy issues arising out of

legal mandates, the President's priorities, or the principles set forth

in this Executive Order.

Pursuant to the terms of this Executive Order, OMB has determined

that this ANPR is a ``significant regulatory action'' because a lead

SNUR may raise novel legal or policy issues. As such, this action was

submitted to OMB for a 10-day review, and any comments or changes made

in response to OMB suggestions or recommendations have been documented

in the public record.

List of Subjects in 40 CFR Part 721

Environmental protection, Chemicals, Hazardous materials,

Recordkeeping and reporting requirements, Significant new uses.

Dated: September 20, 1994.

Lynn R. Goldman,

Assistant Administrator for Prevention, Pesticides and Toxic

Substances.

[FR Doc. 94-23981 Filed 9-27-94; 8:45 am]

BILLING CODE 6560-50-F