Daily Rules, Proposed Rules, and Notices of the Federal Government
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 * * * .”
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 (Öko-Institut e.V., Final Report: Adaptation to Scientific and Technical Progress of Annex II, Directive 2000/53/EC, §§ 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.
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,
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
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
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.
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.
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
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
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.