[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

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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