[Federal Register Volume 74, Number 124 (Tuesday, June 30, 2009)]
[Notices]
[Pages 31254-31258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15449]
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CONSUMER PRODUCT SAFETY COMMISSION
Notice of Stay of Enforcement Pertaining to Bicycles and Related
Products
AGENCY: Consumer Product Safety Commission.
ACTION: Stay of enforcement.
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SUMMARY: The Consumer Product Safety Commission (``CPSC'' or
``Commission'') is announcing its decision to stay enforcement of
section 101 (a) of the Consumer Product Safety Improvement Act of 2008
(``CPSIA'') with regard to certain parts of bicycles, jogger strollers,
and bicycle trailers designed or intended primarily for children 12
years of age or younger. The Commission is staying enforcement of the
specified lead level as it pertains to certain parts of these products,
specifically components made with metal alloys, including steel
containing up to 0.35 percent lead, aluminum with up to 0.4 percent
lead, and copper with up to 4.0 percent lead.
DATES: This stay of enforcement is effective on June 30, 2009 and will
remain in effect until July 1, 2011. The
[[Page 31255]]
Commission may, based on evidence submitted to the Commission as
described in the SUPPLEMENTARY INFORMATION portion of this document,
decide to continue the stay for an additional period of time.
FOR FURTHER INFORMATION CONTACT: John ``Gib'' Mullan, Assistant
Executive Director for Compliance and Field Operations, U.S. Consumer
Product Safety Commission, 4330 East West Highway, Bethesda, Maryland
20814; e-mail [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On August 14, 2008, Congress enacted the Consumer Product Safety
Improvement Act of 2008 (``CPSIA''), Public Law 110-314, 122 Stat.
3016. Section 101(a) of the CPSIA phases in declining limits on
allowable lead content in children's products (defined as a consumer
product designed or intended primarily for children 12 years of age or
younger), starting on February 10, 2009 with 600 ppm and decreasing to
300 ppm on August 14, 2009. On August 15, 2011, the lead limit will be
100 ppm unless the Commission determines that a limit of 100 ppm is not
technologically feasible for a product or a product category. The law
does contain certain exclusions from the lead limits. One is for
component parts that contain more than the allowable lead content, but
where the component is not accessible to a child through normal and
reasonably foreseeable use and abuse. The Commission can also
determine, for certain electronic devices, that it is not
technologically feasible for them to comply immediately with the lead
limits and shall establish a schedule by which such devices shall be in
full compliance unless the Commission determines that full compliance
will not be technologically feasible for such devices within a schedule
set by the Commission. The Commission also, under section 101 (b)(1) of
the CPSIA may exclude a specific product or material that exceeds the
lead limits if the Commission determines on the basis of the best
available, objective, peer-reviewed, scientific evidence that lead in
such product or material will neither: (1) Result in the absorption of
any lead into the human body, taking into account normal and reasonably
foreseeable use and abuse of such product by a child, including
swallowing, mouthing, breaking, or other children's activities, and the
aging of the product; nor (2) have any other adverse impact on public
health or safety.
On March 11, 2009, the Commission issued a final rule on procedures
and requirements for seeking, inter alia, an exclusion under section
101(b)(1) of the CPSIA for materials and products that exceed the lead
content limits. 74 FR 10475. The final rule set forth: (1) That a
request for exclusion must be accompanied by evidence that will meet
the statutory test for the exclusion outlined above; and (2) that the
Office of Hazard Identification and Reduction (``EXHR'') staff would
evaluate the evidence and provide a scientific recommendation to the
Commission as to whether the party submitting the request had met this
statutory test.
The Bicycle Product Suppliers Association (``BPSA'') filed a
petition to exclude a class of materials for certain parts of bicycles,
jogger strollers, and bicycle trailers intended for children ages 12
and younger under section 101(b)(1) of the CPSIA. The petition was
submitted prior to March 11, 2009, the date of the issuance of the
final rule on procedures or requirements for seeking an exclusion under
section 101(b)(1) of the CPSIA. The Commission has decided to treat
this petition as a request for exclusion under these procedures. The
petitioners sought exclusion for components made with metal alloys,
including steel containing up to 0.35 percent lead, aluminum with up to
0.4 percent lead, and copper with up to 4 percent lead. Specified
components include, but are not limited to: Tire valve stems, spoke
nipples, brake levers, and brake lever bushings.
The petitioners submitted an exposure study, extrapolated from the
``best-available existing data'' based on an analysis of the lead in
metal jewelry (for an aluminum and a brass alloy) and a faucet (for a
brass alloy). This study concluded ``estimated lead intakes from
bicycle and related product components are well below background
intakes of lead from food and water, and * * * such intake will not
result in a measurable impact on blood lead levels in children * * *
.'' Exposure Evaluation of Manufactured Components in Consideration for
Exclusion from the Consumer Product Safety Improvement Act (CPSIA),
Gradient Corporation (January 26, 2009).
The petitioners also asserted that steel, aluminum, and copper
alloys containing lead are necessary for the functional purpose of the
equipment and replacement-part components. For support, they point to
the European Union's End-of-Life Vehicles (ELV) Directive exemptions
for lead in steel, aluminum and copper alloys ([Ouml]ko-Institut e.V.,
Final Report: Adaptation to Scientific and Technical Progress of Annex
II, Directive 2000/53/EC, Sec. Sec. 4.2, 4.4, and 4.5, (Jan. 16,
2008)), and the Restriction of Certain Hazardous Substances in
Electrical and Electronic Equipment (RoHS) Directive (EU Directive
2002/95/EC, January 27, 2003), which are based on the contribution of
lead to the machinability, strength and corrosion resistance, and the
availability (or lack thereof) of substitute materials that do not
contain lead.
The Commission denied the petitioners' request for exclusion under
section 101(b)(1) of the CPSIA. However, for the reasons discussed
below, the Commission has decided to issue a temporary stay of
enforcement.
II. Discussion
The petitioners provided data suggesting that the components in
children's bicycles and related products contain lead in amounts not
greater than those permitted under the RoHS and ELV Directives. As
noted earlier in Part I of this document, the petition was filed before
the Commission issued its final rule on procedures and requirements,
and therefore, before the petitioners knew how the Commission would
interpret the language in section 101(b)(1) of the CPSIA. Thus, they
presented information that the lead exposure from their components
would neither result in any measurable increase in blood lead level (a
conclusion that the Commission has since determined is not dispositive
of the absorption analysis in section 101(b)(1), although certainly
important to scientists considering the risk of lead exposure), nor
have any adverse impact on public health and safety. The exposure study
was not based on actual measurements or analysis of the component parts
of children's bicycles and related products and the materials may or
may not be sufficiently similar to the bicycle component parts to serve
as a reasonable basis for the evaluation. Children riding these
bicycles and related products will touch the brake levers, and may also
touch the tire valve stem and with other component parts. The
petitioners' study did conclude that some lead would be ingested by a
child who touched component parts containing lead in the amount the
report determined to be comparable to a child handling a bicycle's
brake levers and valve stems. The Commission staff has looked at this
modeling data and has stated that if ingestion of lead occurs, some
portion of the ingested lead will be absorbed into the body, however
small the absorbed amount. Because the petitioners' study indicated
that children's use of a bicycle or related products could result in
intake of lead,
[[Page 31256]]
and therefore absorption, the petition did not meet the statutory
requirement for exclusion set out in section 101(b)(1)(A) of the CPSIA.
The petitioners also analogized their situation to the
technological feasibility criterion in the electronics device exclusion
for their reliance on the ELV and RoHS exemptions for certain metal
alloys and components. However, no such criterion is specified in
section 101(b). The ELV and the RoHS Directives are focused on reducing
hazardous waste in landfills and encouraging recycling of these
hazardous waste products and thus have quite different purposes than
the lead provisions of the CPSIA, which focus on protecting children
from exposure to lead through contact with it in children's products.
Nevertheless, the Commission recognizes that, unless it takes some
action with regard to the information provided by the petitioners, the
riders of these bicycles--children 12 and younger--could likely face a
more serious and immediate risk of injury or death. Therefore, the
Commission is today announcing a time-limited stay of enforcement with
regard to certain components of children's bicycles and related
products.
The petitioners allege, and the Commission believes it could bear
out, that if any period of time passes in which youth bicycles are not
available for sale, some parents would allow their children to ride
adult bicycles. The Commission recognizes that correctly sizing the
bicycle to the rider is an important safety consideration and includes
this recommendation in its bicycle safety messages. Children who cannot
comfortably reach the pedals or who have to use the more complicated
braking and gear shift mechanisms found on adult bicycles are at
greater risk of injury than children riding properly sized and equipped
bicycles. In a comprehensive study of bicycle riding done by the
Commission staff in the early 1990s, several reasons were cited for the
higher rates of injury among child riders. The primary reasons were
cognitive and physical immaturity. The study also found that one of the
factors in children's injuries was ``riding the wrong size bicycle.''
This safety dilemma applies equally to bicycles that have already
been made and are in inventory with dealers or have already been sold
and are in the hands of resellers or consumers. If parents with
children aged 12 and younger are unable to buy youth-sized bicycles
(whether new or used) they may very well choose to allow their children
to ride adult bicycles. Bicycles need periodic maintenance and repair.
An inability to obtain certain replacement parts could lead to these
bicycles becoming inoperable, or being ridden with worn parts. If no
substitute parts are available, this would similarly lead to some
parents consenting to their children riding adult bicycles before they
are physically and mentally capable of safely operating them. While it
might be possible to change out some of the non-complying components on
existing bicycles, for many of the components that is simply not an
option. Thus replacement parts that have the same amount of lead
content (or less) as the original part are included in our enforcement
stay.
The petitioners allege that a certain amount of lead is needed in
some component parts of their vehicles for machinability, strength,
corrosion resistance and functionality. The petitioners point to the
ELV Directive for their support of this contention. However, the ELV
Directive's exemption for steel for machining purposes containing up to
0.35% lead by weight seems to rest more on the easier machining
properties of leaded steel than on safety considerations. The ELV
report deals with leaded steels versus unleaded steels, rather than an
analysis of how much lead is actually needed for any particular
application. Galvanized steel does, according to the report, have
advantages in corrosion resistance, which could have safety
implications. The exemption for aluminum for machining purposes with a
lead content up to 0.4% by weight was granted due to its higher
resistance to corrosion and to the extent it is used in brake systems
and perhaps certain other applications, such an exemption would appear
to be safety related. The granting of the exemption for copper alloy
containing up to 4% lead by weight, like steel for machining purposes,
appears to be chiefly because the lead makes the copper more easily
machinable. The ELV report noted that the presence of lead did not
significantly affect the strength or corrosion resistance of the copper
alloy. The petitioners do state that the enhanced machinability of
copper alloys ``permits the creation of deep grooves in threaded parts
such as valve stems that are needed to ensure secure cap and air valve
fitment for safety reasons.'' See Petition for Temporary Final Rule to
Exclude a Class of Materials Under Section 101(b) of the Consumer
product Safety Improvement Act, dated January 28, 2009, at 11. For the
last ELV review, the copper industry was asked to indicate the
applications in which the unavoidable use of lead had safety
implications, but their response had not been received at the time the
report was written. Thus the report's conclusion on copper alloys was
that they were not able to carry out an in-depth evaluation based on
the information that was made available to them and that the exemption
should continue until a full assessment is carried out.
Another argument advanced by the petitioners and also supported by
the ELV report is that, for certain alloys, no acceptable substitutes
exist or if they exist, they do not exist in sufficient quantities to
satisfy the global requirements. In addition, at a public meeting with
the BPSA held on March 11, 2009, petitioners claimed that new bicycles
``still need to rely on recycled materials for frame, brake levers,
associated components, etc.'' and that, ``recycling that material
allows for an uncontrollable potential for trace amounts of lead
greater than the CPSIA limits, especially as the limits step down to
300 parts per million.'' See Statement of John Nedeau, President, BPSA,
at the March 11, 2009, Public Meeting on Bicycles. The meeting is
available for viewing at http://www.cpsc.gov/about/cpsia/bicycles.html.
The Commission staff had very little time to assess these issues
independently. Therefore, the ELV report's analysis, which was strictly
limited to the technological feasibility of a substitute for lead and
not on the higher cost of a viable substitute, is instructive. The ELV
report found, for example, that there was as yet no technologically
feasible way to remove lead from aluminum. To the extent that these
alloys are required for safety reasons related to functionality,
greater durability, or corrosion resistance, removing the lead from
those alloys could result in a bicycle that is more prone to structural
breakage, premature brake failure, or other defects that could present
a risk of injury that should be evaluated to ensure such substitutions
do not result in unintended or unforeseen defects. For example, failure
of a less durable brake lever may result in an inability to stop or
control a bicycle and could result in an injury to the child operating
the bicycle. In contrast, Congress has eliminated the risk analysis
associated with the absorption of lead. Yet, while we acknowledge that
there are adverse health effects associated with lead poisoning or
elevated blood lead levels, we also must acknowledge that, there may be
a greater risk of injury to children if the removal of lead from these
components results in structural weakness or other defects, such as
brake
[[Page 31257]]
or frame failure, which can cause the rider to lose control of the
bicycle and/or crash which are more significant than any risks
associated with the possible absorption of lead. To the extent jogger
strollers and bicycle trailers designed or intended primarily for
children 12 years of age or younger contain components made with the
same metal alloys needed for durability and corrosion resistance, the
failure of these components would present similar risks of injury to
the children riding in them as would a component failure in a bicycle.
In such circumstances, enforcement discretion is the only means for the
Commission to protect children.
The petitioners did not address what level of lead is necessary for
their various components to meet acceptable functionality, durability
and corrosion criteria. The industry, at the March 11, 2009 public
meeting indicated that in terms of the uncontrollable variability of
the lead content in the metal alloys they buy, ``the ongoing challenge
is the variability in the recycled materials and the upcoming 300 ppm
standard'' in August of this year. ``We're concerned that even though
we specify this and even though we check for it, inevitably some of it
may get through.'' Comments of Bob Burns and John Nedeau, March 11,
2009, Public Meeting on Bicycles.
The petitioners appeared to be in various stages of attempting to
comply with the lead limits. They stated at the March 11, 2009 public
meeting that they have been working diligently to remove, substitute or
make essential lead-containing components inaccessible. Comments of
John Nedeau, March 11, 2009, Public Meeting on Bicycles. For example,
they discussed changes in the design of the tire valve by extending the
rubber on the stem further up towards the brass valve and placing the
cap on the stem securely. Bob Burns stated that such changes would
result in the stem/cap combination passing the use and abuse torque
test. In addition, they have been working on the exterior portion of
the brass valve to contain less than 300 ppm lead. However, issues
still remained with the accessible inner portion on the valve, or the
valve core, the machinability of which is critical for air retention.
Despite industry attempts, they have not yet been able to source a
valve core that is below the 600 or 300 parts per million standard.
Comments of Bob Burns, March 11, 2009, Public Meeting on Bicycles. The
industry also stated that bicycles are different from ATVs and that
there is a high-end industry and a low-end industry. According to Bob
Burns, lower-priced, heavier bicycles are more likely to have recycled
or less refined materials and it may not be possible to use virgin
alloys. Although he indicated that higher end bicycle manufacturers may
be able to source compliant metals, he questioned whether sourcing
compliant metals would be competitively feasible in the lower price
markets. Id.
In carrying out its responsibilities to protect the public, the
Commission must consider the more immediate safety issue that needs to
be addressed and that is presented by requiring the immediate change in
construction materials for bicycles that would be needed to comply with
the CPSIA. The Commission currently lacks the information it needs to
make a thorough assessment of this industry's state of compliance with
the lead limits. The industry needs more time to gather this
information, taking into account their on-going work in this area, and
the Commission needs time to review that information. To afford the
manufacturers an appropriate amount of time to continue the testing
they are already doing and to conduct any research and development
necessary to bring component parts into compliance with the CPSIA and
to identify any parts that are either technologically infeasible to
bring into compliance during the stay period or identify those where
such compliance, while technologically feasible, would expose children
to other and greater safety risks, the stay will remain in effect until
July 1, 2011. The stay of enforcement here is issued with the
expectation that manufacturers will not simply rely on the continued
stay of enforcement for a particular metal alloy, but will explore
other ways in which to comply with the lead limits before the stay
expires on July 1, 2011.
III. The Stay
The United States Consumer Product Safety Commission hereby stays
enforcement of section 101(a) of the Consumer Product Safety
Improvement Act of 2008 (``CPSIA'') and related provisions with respect
to certain parts of bicycles, jogger strollers, and bicycle trailers
designed or intended primarily for children 12 years of age or younger,
until July 1, 2011, upon the following conditions:
A. The stay shall apply to bicycles, jogger strollers, and bicycle
trailers (``Bicycles and Related Products'') that were manufactured
before February 10, 2009, and to Bicycles and Related Products made on
or after that date through June 30, 2011. The stay with regard to
Bicycles and Related Products made during this time period shall remain
in effect for the life of those products.
B. The stay shall apply only to the following types of original
equipment parts for Bicycles and Related Products: Components made with
metal alloys, including steel containing up to 0.35 percent lead,
aluminum with up to 0.4 percent lead, and copper with up to 4.0 percent
lead.
C. The stay shall also apply to any metal part sold separately as a
replacement for one of the parts described above, provided that the
lead content in the replacement part is less than or equal to the lead
content in the part originally installed on the Bicycles and Related
Products.
D. Each manufacturer (which can include a distributor where
appropriate) who is covered by the stay shall file with the Secretary
of the Commission, not later than 60 days after the publication of this
stay in the Federal Register, a report identifying each model of
Bicycle or Related Product it has produced between May 1, 2008 and May
1, 2009. For each such model, the manufacturer shall give the
production volume by calendar month and shall list each component part
that is made of metal and that is accessible to children, the material
specification for each part, and a measurement of the lead content of
representative samples of each part in parts per million(ppm). The lead
content measurement may be by x-ray fluorescence or the method posted
on the Commission web site to test for lead in metal for certification
purposes.
E. No later than December 31, 2009, each manufacturer covered by
the stay shall present a comprehensive plan to the Commission
describing how and when it intends to reduce the lead exposure from
each part described in paragraph D above whose measured lead content
exceeds 300 parts per million. The manufacturer should include a
discussion of any adverse safety impacts that could result from
accelerating the estimated schedule. If some Bicycles or Related
Products have been modified after January 28, 2009, to reduce the lead
content of certain parts or to make certain parts inaccessible, the
manufacturer should outline those changes in general terms and the
dates such changes were made.
F. Manufacturers who have timely submitted both the report in
paragraph D and the plan in paragraph E above, who need additional time
to complete their plan prior to the expiration of the stay may seek an
extension of the stay. They shall, no later than December 31, 2010,
file a request with the Secretary of the Commission for an extension
containing a revised timetable for the reduction of lead exposure from
those parts. The report shall detail the
[[Page 31258]]
manufacturer's progress in reducing children's exposure to lead from
each part containing more than 300 ppm, specifying what actions have
been taken with regard to each affected part. The report will also
explain why any parts that remain above 300 ppm have not been able to
be made inaccessible, substituted with another material, or made with a
complying level of lead.
G. Any report submitted under paragraph F shall also identify the
Bicycles and Related Products by model that the manufacturer intends to
produce on or after July 1, 2011. The manufacturer shall provide a
listing of each component part that is expected to be used in the
production if its lead content is expected to exceed 100 ppm and will
be accessible to children. For each such part the manufacturer shall
explain why it is not feasible to make the part inaccessible or why it
is not technologically feasible to reduce the lead content to 100 ppm
or lower.
H. While the stay is in effect for particular Bicycles and Related
Products, the Office of Compliance shall not prosecute any person for
any violation of laws administered by the Commission based on the lead
content of any part of, or replacement part for, those Bicycles and
Related Products to which the stay applies, including provisions
relating to certification of compliance, reporting of noncompliances,
or the sale, offering for sale, importation, or exportation.
I. While the stay is in effect for particular Bicycles and Related
Products, the Commission will not refuse admission into the United
States of such Bicycles and Related Products based on the lead content
of any part of such Bicycles and Related Products to which the stay
applies or any replacement part for such Bicycles and Related Products
as described in paragraph C.
J. This stay does not apply to Bicycles and Related Products that
are stockpiled by the manufacturer, as that term is defined by 15
U.S.C. 2058(g)(2), and stockpiling is strictly prohibited.
K. The Commission hereby delegates to the Assistant Executive
Director, Office of Compliance and Field Operations, authority to
implement the stay of enforcement as specified here and the authority
to modify provisions in individual cases where necessary due to unique
or unforeseen circumstances.
The stay in no way limits the Commission's ability to take action
with regard to Bicycles and Related Products for other safety-related
issues including, but not limited to, failure to comply with the ban on
lead-containing paint.
Dated: June 25, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-15449 Filed 6-29-09; 8:45 am]
BILLING CODE 6335-01-P