[Federal Register Volume 89, Number 246 (Monday, December 23, 2024)]
[Proposed Rules]
[Pages 104486-104493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30401]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Chapter I
[EPA-HQ-OPPT-2024-0085; FRL-5398-06-OCSPP]
RIN 2070-AJ64
Lead Wheel Weights; Petition for Rulemaking Under the Toxic
Substances Control Act (TSCA); Decision Not To Proceed With a
Rulemaking
AGENCY: Environmental Protection Agency (EPA).
ACTION: Petition; reasons for Agency response.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA or Agency) has
decided not to proceed with the development of a regulation addressing
the manufacture, processing, or distribution in commerce of lead for
wheel-balancing weights (``lead wheel weights'') under the Toxic
Substances Control Act (TSCA). This action relates to a citizen
petition filed with the Agency in 2009 (``2009 petition''). The 2009
petition, which EPA granted, asked EPA to initiate a rulemaking
proceeding to regulate the manufacturing, processing, or distribution
in commerce of lead wheel weights. In 2023, the same parties filed a
petition for a writ of mandamus (``mandamus petition'') that sought to
compel EPA to initiate the rulemaking proceeding requested in the 2009
petition. After reviewing the information submitted in response to an
advance notice of proposed rulemaking (ANPRM) issued in April 2024 and
EPA's technical analysis thereof, EPA has decided not to proceed with
the development of a proposed rule. Addressing potential remaining
exposures from lead continues to be a high priority for EPA, as
reflected in EPA's announcement that ``Lead and Lead Compounds'' is on
its list of candidate chemical substances currently being considered
for future prioritization actions under TSCA.
DATES: This decision is effective December 23, 2024.
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2024-0085, is available online
at https://www.regulations.gov. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Technical information: Sean Duenser, Existing Chemicals Risk
Management Division (7404M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (202) 343-9157; email address:
[email protected].
General information: The TSCA Hotline, ABVI-Goodwill, 422 South
Clinton Ave., Rochester, NY 14620; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general. It may be of
interest to those who manufacture, process, distribute in commerce,
use, or dispose of lead wheel weights, or their substitutes. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Primary Smelting and Refining of Nonferrous Metal (except
Copper and Aluminum) (NAICS code 331419);
Secondary Smelting, Refining, and Alloying of Nonferrous
Metal (except Copper and Aluminum) (NAICS code 331492);
Lead die-castings, unfinished, manufacturing (NAICS code
331523);
Lead die-castings, unfinished, manufacturing (NAICS code
331523);
[[Page 104487]]
Automobile Manufacturing (NAICS code 336111);
Light Truck and Utility Vehicle Manufacturing (NAICS code
336112);
Heavy Duty Truck Manufacturing (NAICS code 336120);
All Other Motor Vehicles Parts Manufacturing (NAICS code
336399);
Motorcycle, Bicycle, and Parts Manufacturing (NAICS code
336991);
Automobile and Other Motor Vehicle Merchant Wholesalers
(NAICS code 423110);
Motor Vehicle Supplies and New Parts Merchant Wholesalers
(NAICS code 423120);
Tire and Tube Merchant Wholesalers (NAICS code 423130);
Motor Vehicle Parts (Used) Merchant Wholesalers (NAICS
code 423140);
New Car Dealers (NAICS code 441110);
Used Car Dealers (NAICS code 441120);
Recreational Vehicle Dealers (NAICS code 441210);
Motorcycle, Boat, and Other Motor Vehicle Dealers (NAICS
code 441220);
Automotive Parts and Accessories Stores (NAICS code
441310);
Tire Dealers (NAICS code 441320);
General Automotive Repair (NAICS code 811111);
Other Automotive Mechanical and Electrical Repair and
Maintenance (NAICS code 811118);
Automotive Oil Change and Lubrication Shops (NAICS code
811191); and
All Other Automotive Repair and Maintenance (NAICS code
811198).
If you have any questions regarding the applicability of this
action, please consult the technical information contact listed under
FOR FURTHER INFORMATION CONTACT.
B. What is the Agency's authority for taking this action?
TSCA section 21, 15 U.S.C. 2620, allows citizens to petition EPA to
initiate a rulemaking proceeding for the issuance, amendment, or repeal
of a rule under TSCA sections 4, 6, or 8 or an order under TSCA
sections 4 or 5(e) through (f). If EPA grants such a petition, the
Agency must promptly commence an appropriate proceeding. In addition,
under TSCA section 6(a), if EPA determines that the manufacture,
processing, distribution in commerce, use, or disposal of a chemical
substance presents an unreasonable risk to human health or the
environment, it must ``apply one or more of the [TSCA section 6(a)]
requirements . . . to the extent necessary so that the chemical
substance . . . no longer presents such risk,'' which may range from
prohibiting or otherwise restricting the manufacturing, processing, or
distribution in commerce of the chemical substance (or a particular
use), to commercial use requirements or disposal restrictions, to
labeling and recordkeeping, among other requirements.
C. What action is the Agency taking?
EPA is issuing this action to inform the public of its decision not
to regulate the manufacture, processing, or distribution in commerce of
lead for wheel-balancing weights (``lead wheel weights'') under TSCA.
This action is limited to lead for lead wheel weights. EPA's actions to
address ``lead and lead compounds'' more broadly are discussed in Unit
IV.C. This action relates to a citizen petition filed with the Agency
in 2009 under TSCA section 21, which asked EPA to initiate a TSCA
rulemaking proceeding to regulate the manufacturing, processing, or
distribution in commerce of lead wheel weights (Ref. 1). The 2009
petition was filed by representatives of the following groups: Ecology
Center, Sierra Club, Alliance for Healthy Homes, Center for
Environmental Health, Environmental Health Watch, Coalition to End
Childhood Lead Poisoning, United Parents Against Lead, Louisiana ACORN,
Lead Technicians, Tulane University, Drexel School of Public Health,
and one individual (collectively, ``Petitioners''). EPA granted this
petition in 2009. In 2023, the same parties filed a petition for a writ
of mandamus (``mandamus petition'') in the United States Court of
Appeals for the Ninth Circuit: Ecology Center, et al. v. U.S. EPA, No.
23-70158 (9th Cir.) (Ref. 2). The mandamus petition sought to compel
EPA to initiate the rulemaking proceeding requested in the 2009
petition. EPA published for comment a proposed settlement agreement
with the petitioners in March 2024. As part of the settlement
agreement, EPA proceeded with an ANPRM in April 2024. EPA and the
Petitioners then entered into a settlement agreement in September 2024.
EPA is taking this action after reviewing the information submitted
to EPA in response to the ANPRM (Ref. 3), in addition to other
reasonably available information, and this action is also supported by
EPA's technical analysis, entitled: Technical Support Document for Lead
Wheel Weights (TSD) (Ref. 4), which further discusses the low potential
for exposure to children and injury to human health or the environment
from lead wheel weights based on the exposure scenarios evaluated for
this petition.
This action serves as EPA's final decision in response to the 2009
petition. In addition, this action will not have a preemptive effect on
State actions under TSCA section 18.
D. Why is the Agency taking this action?
In April 2024, EPA published an ANPRM seeking information regarding
the use and exposure to lead from the manufacture (including import),
processing (including recycling), distribution in commerce, use, and
disposal of lead wheel weights, as well as information on their
substitutes, to help determine if there is unreasonable risk to human
health and the environment associated with lead wheel weights (Ref. 3).
The Agency received 128 comments providing input on whether to move
forward with the development of a rule regulating lead wheel weights.
The Agency did not, however, receive any lead wheel weight exposure
data during the ANPRM public comment period that it had not already
considered or that would be sufficient to determine that this activity
presents an unreasonable risk of injury to health or the environment
and necessitate a proposed rulemaking, as discussed in Unit IV. As also
addressed in Unit IV., the Agency preliminarily found that risk
associated with residential exposure is lower than previously believed.
The Agency further believes that examination of risks associated with
exposures to lead from the manufacture (including import), processing
(including recycling), distribution in commerce, use, and disposal of
lead wheel weights would be more appropriately assessed and addressed
as part of a broader assessment of exposures associated with lead and
lead compounds during a complete TSCA section 6(b) risk evaluation.
Therefore, EPA is not proceeding with a proposed regulation addressing
lead wheel weights.
II. Background
A. Overview of Lead Wheel Weights
Wheel weights are small pieces of metal or other material used to
correct imbalances in the weight distribution of motor vehicle tires.
Lead has historically been a primary component of many wheel weights
because of its malleability, high density, and relatively low cost.
Nine States in the United States have banned the sale, distribution,
and/or use of lead wheel weights. In addition, many automotive
manufacturers, both those manufacturing within the United States
[[Page 104488]]
and those exporting vehicles to the United States, have switched to
alternative wheel weight options in new vehicle production that meet
the regulatory requirements in those states, citing the impracticality
of using different wheel weights for new vehicles sold only in those
States, due to the interstate and international nature of automotive
production (Ref. 5). For the same reasons, most automotive
manufacturers that sell vehicles in the United States are in compliance
with Canada's prohibition on the use of lead wheel weights as well
(Ref. 5). However, lead wheel weights may still be used for wheel
balancing in auto repair and maintenance of vehicles post-sale. EPA
identified one remaining domestic manufacturer of lead wheel weights in
the United States and EPA has identified multiple importers of lead
wheel weights (Ref. 6). Wheel weights can separate from the wheel due
to failure of the adhesive or clip attaching them, or due to impact of
the wheel with a pothole or road debris, during a crash, or due to
other physical strains. Lead wheel weights that separate from vehicle
wheels, or are not properly disposed of, may be abraded into fine
particles by traffic. Abraded lead particles may then be released into
the air as part of roadway dust due to turbulence from wind or from
passing vehicles. As this lead migrates to nearby homes, it can enter
the yard soil or the indoor dust. Children or adults living nearby can
be exposed through ingestion of soil or dust particles. Lead wheel
weights may also enter the environment by washing off roads during
rain, being thrown from the road intact by vehicles, or by being
collected by street cleaners and disposed of in landfills. Exposure
scenarios identified by Petitioners are addressed further in the TSD
(Ref. 4).
B. Overview of Petitioners Request
1. 2009 Petition
In May 2009, Petitioners submitted a TSCA section 21 petition
requesting that EPA ``establish regulations prohibiting the
manufacture, processing, and distribution in commerce of lead wheel
balancing weights (`wheel weights')'' (Ref. 1). Petitioners raised
concerns that lead wheel weights result in pervasive lead exposure to
children and health effects on ecological receptors. EPA requested
public comment on the petition in July 2009 (Ref. 7) and granted the
petition on August 26, 2009 (Ref. 8). EPA stated in its letter granting
the petition, ``[t]he Agency will promptly commence an appropriate
proceeding under TSCA. EPA anticipates commencing this proceeding
through either an Advance Notice of Proposed Rulemaking or a Proposed
Rule'' (Ref. 8).
2. 2023 Petition for Writ of Mandamus
In August 2023, the same Petitioners sought a writ of mandamus in
the United States Court of Appeals for the Ninth Circuit and asked the
court to direct EPA to conclude the rulemaking Petitioners requested in
the 2009 petition. EPA and Petitioners subsequently entered the Ninth
Circuit Mediation Program. A joint motion to dismiss the petition for
writ of mandamus was filed and granted. EPA was required to either (1)
sign a proposed rule and request publication by the Office of the
Federal Register, or (2) request publication in the Federal Register of
a determination not to proceed with regulating lead wheel weights.
3. What support did the petitioners offer?
In the 2009 petition, Petitioners highlighted that automobiles are
a significant contributor to ongoing lead releases to the environment
and identified lead wheel weight failures as one of the largest ongoing
releases of lead to the environment (Ref. 1). Petitioners cited
research from the New Jersey Department of Environmental Protection
finding that high concentrations of environmental lead are directly
correlated with traffic volume. Petitioners also claimed that the
voluntary National Lead-Free Wheel Weight Initiative (NLFWWI) falls
short of what is needed to protect children, the public, and the
environment given EPA acknowledged that 1.6 million pounds of lead is
lost when wheel weights fall off during normal driving conditions.
EPA granted the 2009 petition on August 26, 2009. In the 2023
mandamus petition, the Petitioners provided discussion on the danger
posed by lead, stating that lead is a toxic heavy metal for which there
is no safe level of exposure, citing EPA's own Integrated Science
Assessment for Lead from 2013 (Ref. 9), and the Reconsideration of the
Dust-Lead Hazard Standards and Dust-Lead Post Abatement Clearance
Levels proposed rule (Ref. 10). Petitioners also discussed the impacts
on human health and the environment related to lead exposures,
stressing that children are at particularly high risk of harm from lead
exposure (Ref. 2). Specifically, Petitioners noted that children
experiencing disproportionate impacts due to racial and socioeconomic
disparities are at high risk of harm. Petitioners also noted that lead
causes detrimental environmental effects to fish and wildlife (Ref. 2).
Petitioners raised that lead from lead wheel weights is one pathway of
exposure to humans, claiming that lead wheel weights enter the
environment, and ultimately people's bodies when they are dislodged
from vehicles, despite the availability of safer, lead-free, wheel
weight alternatives in the market (Ref. 2). Petitioners also provided
comment and numerous studies in response to the ANPRM; however, no new
information that could be used to inform exposure to lead wheel weights
was identified in the comments.
C. Overview of the 2024 ANPRM
In order for EPA to consider lead wheel weight regulation under
TSCA section 6(a), the agency needs technical data linking lead wheel
weight exposure to effects on human health and the environment in order
to inform whether lead wheel weights pose unreasonable risk. EPA issued
an ANPRM on April 3, 2024, requesting comment and information from the
public and all stakeholders on the use and exposure to lead from the
manufacture (including import), processing, distribution in commerce,
use, and disposal of lead wheel weights, as well as information on
their substitutes (Ref. 3). EPA received 21,297 comments, of which 128
were posted to the docket, including 8 unique comments from
Petitioners; mass mailers; comments from the recycling, metal, and
automotive industries; and a scientific organization (Ref. 11). The
Agency did not receive additional data in response to the ANPRM that
could be used in its technical analysis to support a proposed
rulemaking.
1. ANPRM Comment Summary
The following is a summary of comments received on EPA's ANPRM for
lead wheel weights (Ref. 3). This is intended to serve as a summary,
rather than an opportunity for EPA to respond to each individual
comment.
a. Lead Wheel Weight Effects on Human Health and the Environment
Petitioners and advocacy groups support regulatory action for lead
wheel weights based on the rationale that this would protect children's
health (Ref. 12). Petitioners stated that fallen lead wheel weights can
lead to potential exposures to children and adults who inhale or ingest
roadway particles containing lead from wheel weights or who drink
contaminated water (Ref. 12). They commented that even very low blood
lead levels are associated with
[[Page 104489]]
neurodevelopmental harm with irreversible effects in children and
increased risks of cardiovascular disease in adults (Ref. 12). Another
commenter stated that scientists now recognize that lead does lasting
harm to children even at extremely low exposure levels. The commenter
cited the 2012 National Toxicology Program conclusion that blood lead
concentrations below 5 [micro]g/dL have adverse effects on academic
achievement, IQ, and attention-related behaviors (Ref. 13).
The commenter added that people from backgrounds with socioeconomic
disparities live closer to transportation roadways and are more
vulnerable to exposure to lead wheel weights that have fallen from
vehicles. The commenter stated that exposure to lead from the degraded
wheel weights can occur in a variety of ways, including from
pedestrians in urban areas (and their pets) stepping on dust from lead
wheel weights in city streets and tracking the lead dust into their
homes (Ref. 13). The commenter also noted that it is known that blood
lead levels correlate with transportation corridors (both in and
outside of urban centers) and lead wheel weights contribute to those
transportation-related exposures. The commenter raised the concern that
there is growing evidence that the adverse effects of lead are most
severe in Black and Hispanic children and children in low-income
households. The commenter contended that this suggests that
socioeconomic disadvantages can worsen the impact of lead exposures
(Ref. 13).
b. Safer Wheel Weight Alternatives and Voluntary Programs
Petitioners also commented that there are widely available,
economically viable alternatives to lead wheel weights (Ref. 12).
Another commenter noted that industry has largely shifted into using
zinc or steel alloy wheel weights (Ref. 5). The commenter continued to
discuss that lead content in wheel weights has been reduced from the
over 90% associated with high-density lead wheel weights to the current
0.1% associated with current weights as mandated by multiple State and
international standards. EPA's voluntary NLFWWI, combined with the
actions taken by the States, has resulted in the voluntary removal of
all but trace amounts of lead in wheel weights used in new vehicles
manufactured by NLFWWI members. The commenter stated that this approach
appears to have mitigated the potential for unreasonable risk to human
health or the environment (Ref. 5).
c. State Bans on Lead Wheel Weights
Petitioners are seeking a nationwide ban on lead wheel weights to
streamline regulations and certainty across the United States. In their
comments, Petitioners noted that even though there are existing lead
wheel weight bans in nine States, Petitioners believe Federal action is
required since they claim State bans are incomplete. For example, it is
possible to live in a State where lead wheel weights are banned, such
as Maine, and purchase lead wheel weights from online retailers such as
eBay (Ref. 12). All State bans took place after the 2009 petition was
granted. Another commenter, a trade association representing the auto
industry, countered this assertion by stating that, given the
interstate and international nature of auto production, it would be
impractical to use different wheel weights for new vehicles sold in
only those nine States. Consequently, the commenter noted, all of the
automobile manufacturers in the trade association have switched to
alternative wheel weight options in new vehicle production that meet
the requirements of these State regulations (Ref. 5). The commenter
extended this rationale internationally to Canada, where the country
prohibited the ``manufacturing or importing wheel weights containing
more than 0.1% lead by weight,'' in February 2024 (Ref. 14). The
commenter noted that, for the same reasons, the original equipment
manufacturer members that sell vehicles in the United States are in
compliance with Canada's prohibition on the use of lead wheel weights
(Ref. 5).
d. Federal Regulations on Lead Wheel Weight Recycling Already Exist
One commenter expressed concerns about lead from wheel weights
entering a metal scrap stream. The commenter feared that if the lead
wheel weights are not removed prior to the shredding and crushing
process, they become nearly impossible to locate within the scrap
stream and will be melted in an electric arc furnace (EAF) (Ref. 15).
However, another commenter believed existing regulations suffice,
asserting that regulations for certain EAFs and iron and steel
foundries under the Clean Air Act (CAA) effectively require removal of
lead wheel weights from end-of-life vehicles (ELVs) by automotive
dismantlers and metal shredding facilities. The commenter cited
existing Federal regulations such as the CAA regulations under 40 CFR
part 63, subparts EEEEE (Iron and Steel Foundries), YYYYY (Electric Arc
Furnace Area Sources), and ZZZZZ (Iron and Steel Foundries Area
Sources), which include requirements for these EAFs and foundries to
minimize, to the extent practicable, the presence of lead and lead
containing components in the input ferrous materials supplied to them
(Ref. 16).
e. Economic Value and Obligations To Remove Lead Wheel Weights During
Recovery and Recycling
Multiple commenters also raised the economic value of recovering
lead wheel weights at the recycling stage. One commenter mentioned that
these recycling facilities are heavily regulated under Federal
environmental statutes. The commenter believed that this ensures that
recycling facilities have not just a legal obligation to properly
manage any lead wheel weights, but also appropriate financial assurance
for the future (Ref. 17). Another commenter provided an example of
economic value to the recycling sector, commenting that lead wheel
weights are easily accessible on the wheels of ELVs and are relatively
valuable, especially as a recycled material that meets the ``ropes''
specification. The commenter believed that the low cost of removing
lead wheel weights from the wheels of ELVs combined with their higher
value provides economic incentive to remove them from ELVs as soon as
possible (before further dismantling or shredding). Such removal of
lead wheel weights prior to ELV shredding also provides operational
benefits at the metal shredding facility (e.g., higher quality of
produced recycled ferrous metal and recycled nonferrous metals) (Ref.
16).
2. Additional Industry and Stakeholder Engagement
In addition to issuing the ANPRM, EPA conducted outreach to various
stakeholders in the lead wheel weight industry. EPA identified one
remaining lead wheel weight manufacturer in the United States; other
manufacturers that had previously manufactured lead wheel weights
confirmed their transition to lead-free alternatives, such as steel and
zinc alloy wheel weights, citing the bans of lead wheel weights in nine
States. During discussions with the sole remaining manufacturer and
other stakeholders, as well as review of comments to the ANPRM, EPA
learned that lead wheel weight products are increasingly being imported
into the United States rather than manufactured domestically. EPA
requested exposure data from the manufacturer and did not receive any.
The Alliance for Automotive Innovation, which represents automakers
that produce and
[[Page 104490]]
sell approximately 95 percent of the new light-duty vehicles in the
United States, commented that they surveyed their members and found
that none of their original-equipment manufacturers use lead wheel
weights on new vehicles manufactured or distributed to dealerships in
the United States (Ref. 5).
III. Analysis of Exposure Pathways
A. Children's Roadside Exposure
EPA analyzed the potential exposure pathway of residential exposure
to children from lead-containing road dust from lead wheel weights. IQ
loss in children is considered the most sensitive endpoint for lead
exposure. This quantitative exposure analysis simulated the scenario
for exposure from this pathway (a residence at the intersection of two
busy roads) and estimated the blood lead levels and IQ decrement in
children up to age 7 that could result from exposure to lead dust
created by abraded lead wheel weights that could be tracked-in with
yard soil or blown into a household where children could be exposed
(Ref. 4). This analysis found low risk to children from this pathway
based on the information and data available. The increase in
residential soil and dust lead concentration due to lead wheel weights,
even in the near-roadway scenario, is small compared with other sources
that contribute to lead concentration. Soil and dust lead
concentrations from lead wheel weights, along with residential
background soil and dust lead concentrations taken from the American
Healthy Homes Surveys (AHHS I and II), are presented in table 4-8 of
the Technical Support Document (Ref. 4). The baseline concentrations of
lead in residential soil and dust from the AHHS used in this analysis
were 100.06 [mu]g/g and 79.16 [mu]g/g respectively, and lead wheel
weights contributed an additional 3.02 [mu]g/g and 1.15 [mu]g/g
respectively in the near-roadway scenario. The small contribution of
lead wheel weights to residential lead concentrations leads to small
potential impacts on BLL and IQ loss. The approximate wheel weight
contribution to IQ point decrement was estimated to be 0.026 IQ points
at the higher-end of predicted soil and dust exposure, which
corresponded to a 2-year-old child living near a busy road
intersection. By comparison, the estimated IQ decrement for a 2-year-
old child in the corresponding baseline scenario from residential
background concentrations of lead in soil and dust was 2.61 IQ points
(see table 5-2 in the Technical Support Document (Ref.4)). This means
that the estimated IQ decrement from residential background
concentrations of lead in soil and dust are over 100 times higher than
those expected from lead wheel weight exposure for a 2-year-old child
in the near-roadway scenario.
In the children's roadside exposure scenario, lead wheel weights
are lost from cars onto the road. Lost wheel weights are abraded over
time due to weathering and further traffic abrasion. Some of the lead
that is abraded will be emitted to the air as part of roadway dust due
to roadway turbulence and other dust emission mechanisms. EPA estimated
the road dust from lead wheel weights, accounting for the following
parameters: loss rate of lead wheel weights, fraction of weights
degraded per day, street cleaning frequency, additional wheel weight
removal rate, additional dust loss rate, and emission rate. EPA used a
similar model to characterize deposition to soil resulting from
airborne lead particles emitted from the road, which computed the
steady State amount of lead in the air as a function of distance away
from the road. This model accounted for particle deposition rate,
height of the air compartment, and wind speed. For its yard soil
module, EPA predicted the yard lead concentrations in a receptor yard
near the roadway, downwind from the road, which accounted for soil
depth, half-life of lead in soil, dimensions of the yard, and
accumulation time. Further modeling estimated the contribution of lead
in yard soil from lead wheel weights to indoor dust lead concentrations
in the residence. Each of these model parameters is subject to
uncertainty, and, while EPA attempted to make conservative assumptions,
when possible, not all exposure scenarios could be accounted for. For
details of the assumptions made in estimating children's exposure to
lead from lead wheel weights, please see the accompanying Technical
Support Document (Ref. 4).
EPA determined the effect of lead wheel weights on a hypothetical
child's blood lead level using peer-reviewed models and literature
wherever possible, using approaches and input values similar to those
used in other EPA lead analyses. EPA's blood lead module used the lead
soil, air, and dust concentrations as calculated above as inputs to the
All Ages Lead Model (AALM) version 3.0, an EPA-developed exposure model
of lead across a lifetime. Using this model, blood lead levels were
estimated each year at ages 1 through 7. The results show a low impact
of the exposure to lead wheel weights on blood lead levels through the
first seven years of a child's life. Estimated exposure to lead wheel
weights contributed to an increase of blood lead levels of 0.012 [mu]g/
dL at the higher end of the predicted exposure. That estimate means the
contribution of lead exposure from lead wheel weights led to a less
than 1% estimated increase in blood lead levels. Additionally, EPA
calculated IQ decrements for children exposed to lead wheel weights in
the children's roadside exposure scenario. The effects of lead wheel
weights on lifetime IQ loss were estimated to be small (0.026 IQ points
at the higher-end of predicted exposure) for the near-roadway soil and
dust exposure scenario, and because IQ loss in children is considered
the most sensitive endpoint for lead exposure, other health effects of
near-roadway lead wheel weight exposure in children and adults were not
evaluated, but are expected to be small as well.
B. Ecological Screening Assessment
EPA considered lead wheel weights that are lost from cars and
deposited into streams or freshwater lakes via rainfall by modeling a
short-term exposure scenario and a long-term exposure scenario. In the
short-term exposure scenario, a hypothetical 1-mile roadway drains
directly into a stream after a 1-day rainfall event. The rate of lead
wheel weight loss from cars on all modeled roads in the water
deposition scenario was set to the highest value available in the
scientific literature, representing a busy six-lane road in
Albuquerque, New Mexico (Ref. 18) and corresponding to approximately
five hundred 1-ounce lead wheel weights lost per mile of roadway per
year. EPA expects that this assumption is an overestimate, as most
roads are not six-lane highways and because current rates of lead wheel
weight use are expected to be lower than in 2000, when the Albuquerque
loss rate study (Ref. 18) was published. Nine U.S. States have banned
lead wheel weights since this loss rate study was conducted, and an
industry group representing the manufacturers of approximately 95
percent of new cars sold in the United States currently indicates that
these manufacturers no longer use lead wheel weights on new vehicles
(Ref. 5). Aquatic organisms in streams and lakes can be exposed to lead
through this route. EPA's assessment of this scenario estimates the
lead concentration in water attributable to lead wheel weights that
dissolve in streams and lakes. It considers a 1-day rainfall event and
long-term accumulation of lead wheel weights in freshwater bodies.
This assessment accounted for the following parameters: wheel
weight loss
[[Page 104491]]
rate, street cleaning frequency, flow rate of stormwater-receiving
streams, fraction of lead wheel weights that dissolve during each
rainfall event, and water concentrations. EPA assumed that all lead
wheel weights present on the roadway were washed into the stream, that
no rainfall event had occurred since the street was last cleaned, and
that the maximum time had elapsed between street cleaning events (6
months). These assumptions corresponded to slightly more than 257 1-
ounce lead wheel weights simulated to enter the 1-mile stretch of
stream. EPA estimated lead concentrations for varying values of
streamflow and dissolution rates of lead in a 1-day rainfall scenario.
The maximum water concentration attributable to lead wheel weights due
to a 1-day rainfall event is 0.0000164 [mu]g/L (less than 0.1 parts per
trillion), which occurs when 100% of a lead wheel weight dissolves per
year (the fastest dissolution rate modeled), there are only two
rainfall events per year, each immediately preceding the street
cleaning event (leading to the maximum possible accumulation of lead
wheel weights), and the stream flow rate is 50 cubic feet per second
(the smallest stream modeled). By comparison, the level of concern for
acute freshwater aquatic exposure to lead in water is 65 [mu]g/L (Ref.
19). Therefore, under the most conservative conditions modeled (a fast
dissolution rate for lead wheel weights, and a small stream containing
a low volume of water in which to dilute the wheel weights' lead
contribution), the estimated water concentration of lead attributable
to wheel weights remains far below the level of concern for acute
toxicity in freshwater organisms. The slow dissolution rate of lead
wheel weights and the relative insolubility of inorganic lead in water
means that the estimated acute exposure to lead in freshwater streams
due to lead wheel weights (0.0000164 [mu]g/L) is far below the acute
level of concern for aquatic life (65 [mu]g/L), indicating that acute
toxicity to freshwater organisms from lead wheel weights is unlikely
based on this analysis.
EPA also considered a long-term ecological exposure scenario.
Depending on certain conditions (e.g., water acidity), lead wheel
weights that have been swept up by rainfall and deposited in freshwater
ponds and lakes can dissolve over time, increasing the lead water
concentration. EPA's analysis of this scenario considers the average
contribution of lead wheel weights to freshwater lead concentration on
a national scale. The model was based on determining the accumulated
mass of wheel weights in water, the rate at which they dissolve, the
volume of water, and the rate at which fresh water is replaced by
rainfall. This analysis determined that the highest estimated lead
concentration in water was 0.0009 [mu]g/L (less than 1 part per
trillion), which is below the criterion continuous concentration (CCC)
hazard level for freshwater aquatic life, which ranges from 1.3 to 7.7
[mu]g/L depending on water hardness with a default value at 2.5 [mu]g/L
(corresponding to 100 mg/L hardness as CaCO3). This estimate
included the assumption that 100 percent of lost lead wheel weights are
deposited in water bodies. Therefore, actual average lead
concentrations in the environment due to lead wheel weights are likely
lower, although limitations in the analysis due to the national scale
of the long-term ecological exposure scenario means that individual
water bodies may experience different contributions of lead from lead
wheel weights depending on their location relative to roads. For
further details on the technical analyses conducted in support of this
action, please see the accompanying Technical Support Document.
IV. Decision Not To Proceed With Rulemaking
A. EPA's Analysis Estimates Low Impacts to Children and the Environment
From Exposure to Lead Wheel Weights
Children exposed to lead are at an increased risk of adverse health
effects, including decreased cognitive performance, greater incidence
of problem behaviors, and increased diagnoses of attention-related
behavioral problems. The negative health effects associated with lead
exposure are well-documented, and include neurological, cardiovascular,
renal, reproductive, developmental, and hematological effects (Ref.
20). Several studies have demonstrated a link between increased blood
lead level (BLL) and IQ loss in children (Ref. 21 and Ref. 22). IQ loss
is among the most sensitive endpoints studied (i.e., IQ loss occurs at
a lower BLL than other health effects and therefore IQ loss is used as
a reference for lead's adverse health effects in children). EPA
calculated IQ decrements for children exposed to lead from lead wheel
weights in a near-roadway scenario, where lead is released into the
roadway environment due to abrasion of lost wheel weights, the lead
migrates to the air surrounding the home, the deposition of lead
particles contributes to yard soil concentrations, and outdoor soil
lead levels influence the indoor dust lead levels in the residence
(Ref. 4). The effects of lead wheel weights on lifetime IQ loss were
estimated to be low for the near-roadway soil and dust scenario. At
ages 2 and 7, lifetime IQ loss models with conservative assumptions
found the contribution of lead wheel weights to result in an estimated
difference in lifetime IQ loss of 0.026 points for this exposure
scenario. This means that near-roadway soil and dust exposure from
abraded lead wheel weights added approximately 1 percent to the IQ loss
already attributable to exposure to other sources of lead.
Lead exposure can also cause adverse effects in animals and plants
in the environment (Ref. 20). EPA estimated water concentrations in
streams and water bodies attributable to lead wheel weights lost from
vehicles and compared them to the freshwater levels of concern
published in the Ambient Water Quality Criteria for Lead (Ref. 19).
These levels of concern represent acute and chronic lead concentrations
in freshwater that EPA considers harmful to wildlife. In the acute
(short-term) and chronic (long-term) scenario, EPA's analysis estimated
that the concentration of lead in freshwater streams and water bodies
attributable to lead wheel weights was less than 1 part per trillion.
By comparison, the freshwater levels of concern are 65 parts per
billion for acute exposure, and 2.5 parts per billion for chronic
exposure. The estimated lead exposure of wildlife in freshwater due to
lead wheel weights is several orders of magnitude lower than the acute
and chronic levels of concern, indicating low potential for adverse
effects. See EPA's TSD for more information (Ref. 4).
In addition to the conclusions made in EPA's analysis, the Agency
did not receive, during its engagement with stakeholders and with the
sole remaining domestic lead wheel weight manufacturer, or during the
30-day public comment period for the ANPRM, additional data that could
be used in the TSD that would support a proposed rulemaking for lead
wheel weights. The Agency did receive comment from the Alliance for
Automotive Innovation, which represents automakers that produce and
sell approximately 95 percent of the new light-duty vehicles in the
United States. They surveyed their members and found that none of their
original-equipment manufacturers use lead wheel weights on new vehicles
manufactured or distributed to dealerships in the United States (Ref.
5).
B. Statutory and Regulatory Context
In the August 2023 mandamus petition (Ref. 2), Petitioners cite
EPA's
[[Page 104492]]
proposed rule entitled, ``Reconsideration of the Dust-Lead Hazard
Standards and Dust-Lead Post-Abatement Clearance Levels'' (88 FR 50444,
August 1, 2023 (FRL-8524-01-OCSPP)) (Ref. 10). Specifically,
Petitioners reference EPA's statement: ``[T]here is no evidence of a
threshold below which there are no harmful health effects from lead
exposure.'' This is cited to support the petition's discussion on the
dangers posed by lead and lead wheel weights and, more specifically,
that lead is a dangerous toxic chemical that can cause irreversible
health harms at low levels of exposure. Furthermore, the Federal Lead
Action Plan, developed by the President's Task Force on Environmental
Health Risks and Safety Risks to Children, which comprises 17 Federal
departments and offices, including EPA, states that ``no safe blood
lead level in children has been identified'' (Ref. 23).
EPA is reaffirming these positions and continues its commitment to
strengthening public health protections, addressing lead contamination
for communities with the greatest exposures, and promoting
environmental justice. EPA is clarifying in this document that the
authorities under Title X of the Housing and Community Development Act
of 1992 (also known as the Residential Lead-Based Paint Hazard
Reduction Act of 1992 or ``Title X'') (Pub. L. 102-550) and TSCA Title
IV differ from TSCA section 6.
TSCA Title IV directs EPA to identify the level of dust-lead
exposure that ``would result in adverse human health effects'' as a
type of lead-based paint hazard (15 U.S.C. 2681(10)). In addition, on
May 14, 2021, the United States Court of Appeals for the Ninth Circuit
issued an opinion (2021 Court Opinion) which instructed EPA to consider
only health factors when setting the dust-lead hazard standards
(described as ``dust-lead reportable levels'' in EPA's final rule) (89
FR 89416, November 12, 2024 (FRL-8524-02-OCSPP)). On November 12, 2024,
EPA published the final rule to lower these standards to ``any
reportable level as analyzed by a laboratory recognized by EPA's
National Lead Laboratory Accreditation Program (NLLAP).'' This revision
acknowledges the current state of scientific evidence (i.e., that there
is no evidence of a threshold below which there are no harmful effects
on cognition from lead exposure) and is consistent with the 2021 Court
Opinion. The revised hazard standards are inclusive of any reportable
level of dust-lead and do not distinguish based on health risks posed.
In the same rule, EPA revised the dust-lead action levels (DLAL,
previously known as dust-lead clearance levels), which are the
allowable levels of dust-lead loadings on a surface following
completion of an abatement activity outlined in the Lead-based Paint
Activities Rule (40 CFR 745.83 and 745.223). The revised DLAL are 5
[mu]g/ft\2\, 40 [mu]g/ft\2\, and 100 [mu]g/ft\2\ for floors, window
sills, and troughs, respectively, and are the levels at which EPA
recommends an abatement or other lead hazard control measures.
Therefore, under the Lead-based Paint Activities Rule, in instances
where reportable dust-lead levels are present (i.e., a dust-lead
hazard), EPA recommends lead hazard control work only when the levels
are at or above the DLAL.
Under TSCA section 6(a), ``[i]f the Administrator determines in
accordance with subsection (b)(4)(A) that the manufacture, processing,
distribution in commerce, use or disposal of a chemical substance or
mixture, or that any combination of such activities, presents an
unreasonable risk of injury to health or the environment, the
Administrator shall by rule . . . apply one or more of the [section
6(a)] requirements to such substance or mixture to the extent necessary
so that the chemical substance no longer presents such risk.'' EPA
looks to section 6(b) and its implementing regulations (Ref. 24) when
considering whether a chemical substance presents an unreasonable risk.
Pursuant to TSCA section 6(b), EPA must decide whether the ``chemical
substance presents an unreasonable risk of injury to health or the
environment, without consideration of costs or other non-risk factors,
including an unreasonable risk to potentially exposed or susceptible
subpopulations identified as relevant to the risk evaluation by the
Administrator, under the conditions of use.'' For example, TSCA section
6(b)(4)(F) states: ``In conducting a risk evaluation under this
subsection, the Administrator shall . . . integrate and assess
available information on hazards and exposures for the conditions of
use of the chemical substance.'' When determining unreasonable risk,
the Agency weighs the effects of the chemical substance on health and
human exposure under the conditions of use; the effects of the chemical
substance on the environment and environmental exposure under the
conditions of use; the population exposed (including any potentially
exposed or susceptible subpopulations), the severity of hazard (the
nature of the hazard, the irreversibility of hazard), and
uncertainties.
C. Including Lead and Lead Compounds in the TSCA Prioritization Process
EPA's work to protect children from exposure to lead is ongoing,
and reducing childhood lead exposure continues to be a priority for
both EPA and the Federal Government (Federal Lead Action Plan) (Ref.
23). There are multiple sources of lead including lead-based paint,
lead in drinking water, and lead contaminated dust and soil. As a part
of this action, the Agency analyzed the potential risk from lead in the
environment as a result of lead from fallen wheel weights, which could
in turn contaminate residential soil, residential dust, surface water,
and groundwater, as these risks were the focus of the 2009 petition.
EPA recognizes there are many other potential sources of lead exposure,
including occupational exposure during the production and processing of
lead wheel weights. However, EPA believes these exposures would be more
appropriately assessed when ``Lead and Lead Compounds'' are prioritized
and a full risk evaluation under TSCA section 6(b) with peer review can
be conducted. During this process, EPA will conduct a comprehensive,
peer reviewed, risk evaluation to determine whether lead and lead
compounds present an unreasonable risk of injury to health, without
consideration of costs or other non-risk factors, including an
unreasonable risk to potentially exposed or susceptible subpopulations
identified. EPA will identify, where relevant, the likely duration,
intensity, frequency, and number of exposures to lead and lead
compounds under each condition of use for each step in the chemical's
life cycle. EPA may also need to develop a peer-reviewed threshold to
determine the level of adult health effects that would be considered
unreasonable during the risk evaluation process.
EPA has included ``Lead and Lead Compounds'' on its list of
candidate chemical substances currently being considered for future
prioritization actions. As described in 40 CFR 702.5(c)(2), EPA is
required to ensure that, at any given time, at least 50 percent of TSCA
risk evaluations are drawn from the TSCA 2014 Work Plan (Ref. 25). Lead
and lead compounds are included in the TSCA 2014 Work Plan, but
prioritization and risk evaluation for lead and lead compounds have not
yet been initiated (Ref. 26). During a risk evaluation, lead and lead
compounds would undergo a 3-year robust and comprehensive review of
hazards and exposures and consider the weight of the scientific
evidence as required by
[[Page 104493]]
TSCA section 6(b)(4)(F), including peer-review of scientific
information, technical procedures, measures, methods, protocols,
methodologies, or models used in the evaluation, employed in a manner
consistent with the best available science, in accordance with TSCA
section 26(h).
V. References
The following is a list of the documents that are specifically
referenced in this document. The docket includes these references and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the reference is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
1. Ecology Center. TSCA Section 21 Petition Requesting EPA to
Establish Regulations Prohibiting the Manufacture, Processing, and
Distribution in Commerce of Lead Wheel Balancing Weights. May 28,
2009. https://www.epa.gov/sites/default/files/2015-10/documents/petition4.pdf.
2. United States Court of Appeals for the Ninth Circuit. Petition
for Writ of Mandamus. August 22, 2023. https://www.epa.gov/system/files/documents/2024-01/petition-for-review.pdf.
3. U.S. EPA. Lead Wheel Weights; Regulatory Investigation Under the
Toxic Substances Control Act (TSCA). Federal Register. 89 FR 22972,
April 3, 2024 (FRL-5398-05-OCSPP). https://www.govinfo.gov/content/pkg/FR-2024-04-03/pdf/2024-06804.pdf.
4. U.S. EPA. Technical Support Document for Lead Wheel Weights.
December 2024.
5. Comment submitted by Alliance for Automotive Innovation. May 9,
2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0037.
6. Abt. Memo, Estimated Volume of LWW Imports, Manufacture, and Use.
July 23, 2024.
7. U.S. EPA. Lead Wheel Balancing Weights; TSCA Section 21 Petition;
Notice of Receipt and Request for Comment. Federal Register. 74 FR
34342, July 15, 2009 (FRL-8424-7). https://www.govinfo.gov/content/pkg/FR-2009-07-15/pdf/E9-16815.pdf.
8. U.S. EPA. EPA Response to TSCA Section 21 Petition. August 26,
2009. https://www.epa.gov/sites/default/files/2015-10/documents/document.pdf.
9. U.S. EPA. Integrated Science Assessment for Lead. July 2013.
https://assessments.epa.gov/isa/document/&deid%3D255721.
10. U.S. EPA. Proposed rule. Reconsideration of the Dust-Lead Hazard
Standards and Dust-Lead Post-Abatement Clearance Levels. Federal
Register. 88 FR 50444, August 1, 2023 (FRL-8524-01-OCSPP). https://www.govinfo.gov/content/pkg/FR-2023-08-01/pdf/2023-15073.pdf.
11. U.S. EPA. Lead Wheel Weight Docket. https://www.regulations.gov/docket/EPA-HQ-OPPT-2024-0085.
12. Comment submitted by Ecology Center et al. May 10, 2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0058.
13. Comment submitted by Project TENDR (Targeting Environmental
Neuro-Development Risks), The Arc of the U.S. May 9, 2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0039.
14. Canada Gazette. Prohibition of the Manufacture and Importation
of Wheel Weights Containing Lead Regulations. Part II, Volume 157,
Number 4. February 3, 2023. https://gazette.gc.ca/rp-pr/p2/2023/2023-02-15/html/sor-dors15-eng.html.
15. Comment submitted by Steel Manufacturers Association (SMA). May
9, 2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0038.
16. Comment submitted by Recycled Materials Association (ReMA). May
9, 2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0041.
17. Comment submitted by Association of Battery Recyclers, Inc.
(ABR), Battery Council International (BCI), and International Lead
Association (ILA). May 10, 2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0057.
18. Root RA. Lead loading of urban streets by motor vehicle wheel
weights. Environ Health Perspect. 2000 Oct;108(10):937-40. doi:
10.1289/ehp.00108937. PMID: 11049812; PMCID: PMC1240125.
19. U.S. EPA. Ambient Water Quality Criteria for Lead--1984. EPA-
400/5-84-027. Washington, DC: Office of Water, Regulations and
Standards Criteria and Standards Division. January 1985.
20. U.S. EPA. Integrated Science Assessment for Lead. January 2024.
https://assessments.epa.gov/isa/document/&deid%3D359536.
21. Lanphear et al. Low-level environmental lead exposure and
children's intellectual function: an international pooled analysis.
Environ Health Perspect. 2005 Jul;113(7):894-9. doi: 10.1289/
ehp.7688.
22. Lanphear et al. Erratum: Low-Level Environmental Lead Exposure
and Children's Intellectual Function: An International Pooled
Analysis. Environ Health Perspect. 2019 Sep;127(9):99001. doi:
10.1289/EHP5685. PMID: 16002379; PMCID: PMC1257652.
23. President's Task Force on Environmental Health Risks and Safety
Risks to Children. 2018. The Federal Action Plan to Reduce Childhood
Lead Exposures and Associated Health Impacts. https://ptfcehs.niehs.nih.gov/sites/niehs-ptfceh/files/resources/lead_action_plan_508.pdf.
24. U.S. EPA. Procedures for Chemical Risk Evaluation Under the
Toxic Substances Control Act (TSCA). Federal Register. 89 FR 37028,
May 3, 2024 (FRL-8529-02-OCSPP). https://www.govinfo.gov/content/pkg/FR-2024-05-03/pdf/2024-09417.pdf.
25. U.S. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update.
October 2014. https://www.epa.gov/sites/default/files/2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf.
26. U.S. EPA. 2012 TSCA Work Plan Chemicals. June 2012. https://www.epa.gov/sites/default/files/2014-02/documents/work_plan_chemicals_web_final.pdf.
Authority: 15 U.S.C. 2601 et seq.
Dated: December 16, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2024-30401 Filed 12-20-24; 8:45 am]
BILLING CODE 6560-50-P