# Significant New Uses of Lead

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URL: https://www.frixlaw.com/law-library/documents/fr%3A94-23981

## Record

- **Collection:** Federal Register
- **Document type:** Uncategorized Document
- **Published:** September 28, 1994

## Text

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.''
---------------------------------------------------------------------------

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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-23981. Public record. Not legal advice.