[Federal Register Volume 59, Number 187 (Wednesday, September 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23981]


[Federal Register: September 28, 1994]


_______________________________________________________________________

Part III





Environmental Protection Agency





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40 CFR Part 721



Significant New Uses of Lead; Advance Notice of Proposed Rulemaking
ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPTS-50618; FRL-4766-6]
RIN 2070-AC37


Significant New Uses of Lead

AGENCY: Environmental Protection Agency (EPA).

ACTION: Advance notice of proposed rulemaking (ANPR).

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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