95-28761. Proposed Rule: Safety Standard for Bicycle Helmets  

  • [Federal Register Volume 60, Number 234 (Wednesday, December 6, 1995)]
    [Proposed Rules]
    [Pages 62662-62692]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-28761]
    
    
    
    
    [[Page 62661]]
    
    _______________________________________________________________________
    
    Part III
    
    
    
    
    
    Consumer Product Safety Commission
    
    
    
    
    
    _______________________________________________________________________
    
    
    
    16 CFR Part 1203
    
    
    
    Safety Standard for Bicycle Helmets; Proposed Rule
    
    Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / 
    Proposed Rules 
    
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    CONSUMER PRODUCT SAFETY COMMISSION
    
    16 CFR Part 1203
    
    
    Proposed Rule: Safety Standard for Bicycle Helmets
    
    AGENCY: Consumer Product Safety Commission.
    
    ACTION: Proposed rule.
    
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    SUMMARY: Pursuant to the Children's Bicycle Helmet Safety Act of 1994, 
    the Commission is proposing a safety standard that would require 
    bicycle helmets to meet impact-attenuation and other requirements. This 
    proposal modifies the bicycle helmet standard proposed by the 
    Commission in the Federal Register of August 15, 1994.
        The proposed standard establishes requirements derived from one or 
    more of the voluntary standards applicable to bicycle helmets. In 
    addition, the proposed standard includes requirements specifically 
    applicable to children's helmets and requirements to prevent helmets 
    from coming off during an accident. The proposed standard also contains 
    testing and recordkeeping requirements to ensure that bicycle helmets 
    meet the standard's requirements.
    
    DATES: Comments on the proposal should be submitted no later than 
    February 20, 1996.
        Comments on elements of the proposal that, if issued, would 
    constitute collection of information requirements under the Paperwork 
    Reduction Act may be filed with the Office of Management and Budget 
    (``OMB''). OMB is required to make a decision concerning the 
    collections of information contained in the proposed rule between 30 
    and 60 days after publication. Thus, although comments will be received 
    by OMB until February 5, 1996, a comment to OMB is best assured of 
    having its full effect if OMB receives it by January 4, 1996.
    
    ADDRESSES: Comments to the Commission should be mailed to the Office of 
    the Secretary, Consumer Product Safety Commission, Washington, D.C. 
    20207, or delivered to the Office of the Secretary, Consumer Product 
    Safety Commission, room 502, 4330 East-West Highway, Bethesda, Maryland 
    20814-4408, telephone (301)504-0800. Comments also may be filed with 
    the Commission by facsimile to (301)504-0127, or by electronic mail via 
    info@cpsc.gov. Comments should include a caption or cover indicating 
    that they are directed to the Office of the Secretary and are comments 
    on the revised proposed Safety Standard for Bicycle Helmets.
        Comments to OMB should be directed to the Desk Officer for the 
    Consumer Product Safety Commission, Office of Information and 
    Regulatory Affairs, OMB, Washington, D.C. 20503. The Commission 
    encourages commenters to provide copies of such comments to the 
    Commission's Office of the Secretary, with a caption or cover letter 
    identifying the materials as comments submitted to OMB on the proposed 
    collection of information requirements for bicycle helmets.
    
    FOR FURTHER INFORMATION CONTACT: Scott Heh, Project Manager, 
    Directorate for Engineering Sciences, Consumer Product Safety 
    Commission, Washington, D.C. 20207; telephone (301) 504-0494 ext. 1308.
    
    SUPPLEMENTARY INFORMATION:
    
    A. Introduction and Background
    
        Introduction. In this notice, the Consumer Product Safety 
    Commission (``the Commission'' or ``CPSC'') proposes a mandatory safety 
    standard applicable to bicycle helmets.1 This proposal modifies 
    the bicycle helmet standard proposed by the Commission in the Federal 
    Register of August 15, 1994. 59 FR 41719.
    
        \1\The Commission approved this Federal Register notice by a 
    vote of 2-1. Chairman Ann Brown and Commissioner Thomas H. Moore 
    voted to approve it as published. Commissioner Mary Sheila Gall 
    voted to approve the proposed rule with a change, which was not 
    adopted by the Commission, to give companies more time to comply 
    with agency requests for records.
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        The Commission seeks comments from interested members of the public 
    on the revised proposed standard. Comments should be limited to those 
    aspects of the proposed standard that have changed substantively from 
    the earlier proposal, or that are affected by a substantive change.
        Because of the growing use of helmets, other nations may be 
    developing or revising safety standards for bicycle helmets. 
    Accordingly, the Commission invites comments from counterpart agencies 
    in foreign governments, foreign standards developers, and others who 
    might be interested in this proposed standard. This invitation is in 
    addition to the routine international notification of this proposed 
    rule that is provided by the World Trade Organization Agreement on 
    Technical Barriers to Trade.
        Background. Head injury is a leading cause of accidental death and 
    disability among children in the United States, resulting in over 
    100,000 hospitalizations every year. Studies have shown that children 
    under the age of 14 are more likely to sustain head injuries than 
    adults, and that children's head injuries are often more severe than 
    those sustained by adults.
        In general, head injuries fall under one of two main categories--
    focal and diffuse. Focal injuries are limited to the area of impact, 
    and include injuries such as contusions, hematomas, lacerations, and 
    fractures. Diffuse brain injuries (also known as diffuse axonal injury) 
    involve trauma to the neural and vascular elements of the brain at the 
    microscopic level. The effects of such diffuse damage may vary from a 
    completely reversible injury, such as a mild concussion, to prolonged 
    coma and death.
        Based on data from CPSC's National Electronic Injury Surveillance 
    System (``NEISS''), an estimated 606,000 bicycle-related injuries were 
    treated in U.S. hospital emergency rooms in 1994. In addition, about 
    1,000 bicycle-related fatalities occur each year, according to the 
    National Safety Council.
        A Commission study of bicycle use and hazard patterns in 1993 
    indicated that almost one-third of the injuries involved the 
    head.2 Published data indicate that, in recent years, almost two-
    thirds of all bicycle-related deaths involved head injury.3
    
        \2\Gregory B. Rodgers, Deborah K. Tinsworth, Curtis Polen, 
    Suzanne Cassidy, Celestine M. Trainor, Scott R. Heh, Mary F. 
    Donaldson, ``Bicycle Use and Hazard Patterns in the United States,'' 
    U.S. Consumer Product Safety Commission (June 1994) (``Bicycle Use 
    Study'').
        \3\Jeffrey J. Sachs, MPH; Patricia Holmgreen, M.S.; Suzanne M. 
    Smith, M.D.; and Daniel M. Sosin, M.D., ``Bicycle-Associated Head 
    Injuries and Deaths in the United States from 1984 through 1988,'' 
    Journal of the American Medical Association 266 (December 1991): 
    3016-3018.
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        Younger children are at particular risk of head injury. The 
    Commission's 1993 study indicated that when other factors were held 
    constant statistically, the injury risk for children under age 15 was 
    over 5 times the risk for older riders. About one-half of the injuries 
    to children under the age of 10 involved the head, compared to about 
    one-fifth of the injuries to older riders. Children were also less 
    likely to have been wearing a helmet at the time of a bicycle-related 
    incident than were adults.
        Research has shown that helmets may reduce the risk of head injury 
    to bicyclists by about 85 percent, and the risk of brain injury by 
    about 88 percent.4 The Commission's Bicycle Use Study 
    
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    found that about 18 percent of bicyclists wear helmets.5
    
        \4\Robert S. Thompson, M.D.; Frederic P. Rivara, M.D.; and Diane 
    C. Thompson, M.S., ``A Case Control Study of the Effectiveness of 
    Bicycle Safety Helmets,'' The New England Journal of Medicine 320 
    (May 1989): 1361-1367.
        \5\Supra note 1.
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        On June 16, 1994, the Children's Bicycle Helmet Safety Act of 1994 
    (the ``Act'' or ``the Bicycle Helmet Safety Act'') was enacted. 15 
    U.S.C. 6001-6006. Section 205 of this Act provides that bicycle helmets 
    manufactured more than 9 months from that date shall conform to at 
    least one of the following interim safety standards: (1) The American 
    National Standards Institute (ANSI) standard designated as Z90.4-1984, 
    (2) the Snell Memorial Foundation standard designated as B-90, (3) the 
    ASTM (formerly the American Society for Testing and Materials) standard 
    designated as F 1447, or (4) any other standard that the Commission 
    determines is appropriate. 15 U.S.C. 6004 (a)-(b). On March 23, 1995, 
    the Commission published its determination that five additional 
    voluntary safety standards for bicycle helmets are appropriate as 
    interim mandatory standards. 60 FR 15,231. These standards are ASTM F 
    1447-1994, Snell B-90S, N-94, and B-95, and the Canadian voluntary 
    standard CAN/CSA-D113.2-M89. In that notice, the Commission also 
    clarified that the ASTM standard F 1447 referred to in the Act is the 
    1993 version of that standard. The interim standards are codified at 16 
    CFR 1203.
        Section 205(c) of the Act directed the Consumer Product Safety 
    Commission to begin a proceeding under the Administrative Procedure 
    Act, 5 U.S.C. 553, to:
        1. Review the requirements of the interim standards described above 
    and establish a final standard based on such requirements;
        2. Include in the final standard a provision to protect against the 
    risk of helmets coming off the heads of bicycle riders;
        3. Include in the final standard provisions that address the risk 
    of injury to children; and
        4. Include additional provisions as appropriate. 15 U.S.C. 6004(c).
        Section 205(c) the Act provides that the final standard shall take 
    effect 1 year from the date it is issued. 15 U.S.C. 6004(c). Section 
    205(d) of the Act provides that failure to conform to an interim 
    standard shall be considered a violation of a consumer product safety 
    standard issued under the Consumer Product Safety Act (``CPSA''), 15 
    U.S.C. 2051-2084. Section 205(d) also provides that the final standard 
    shall be considered to be a consumer product safety standard issued 
    under the CPSA. However, section 205(c) of the Act provides that the 
    provisions of the CPSA regarding rulemaking procedures, statutory 
    findings, and judicial review (15 U.S.C. 2056, 2058, 2060, and 2079(d)) 
    shall not apply to this proceeding or to the final standard. 15 U.S.C. 
    6004(c). When the final standard becomes effective, it will be codified 
    at 16 CFR 1203 and will replace the interim standards. 15 U.S.C. 
    6004(d).
    
    B. Originally Proposed Standard
    
        The Commission reviewed the bicycle helmet standards identified in 
    the Act (ANSI, ASTM, and Snell), as well as international bicycle 
    helmet standards and draft revisions of the ANSI, ASTM, and Snell 
    standards that were then under consideration. Based on this review, the 
    Commission developed a proposed final safety standard for bicycle 
    helmets. 59 FR 41,719 (August 15, 1994).
        The major features of the originally proposed standard were as 
    follows:
        1. Impact attenuation. The originally proposed standard measures 
    the ability of the helmet to protect the head in a collision by 
    securing the helmet on a headform and dropping the helmet/headform 
    assembly from various heights onto a fixed steel anvil. The original 
    proposal specified a constant mass of 5 kg for the drop assembly (not 
    including the helmet). However, the Commission requested comment on the 
    alternative of specifying a different drop mass for each headform size.
        Under the proposed standard, the helmet is tested with three types 
    of anvils (flat, hemispherical, and ``curbstone,'' as shown in Figures 
    11, 12, and 13 of the revised proposed standard published in this 
    notice). These anvils represent types of surfaces that may be 
    encountered in actual riding conditions. Instrumentation within the 
    headform records the headform's impact in multiples of the acceleration 
    due to gravity (``g''). Impact tests are performed on different 
    helmets, each of which has been subjected to one of four environmental 
    conditions. These environments are: ambient (room temperature), high 
    temperature (117-127  deg.F), low temperature (3-9  deg.F), and 
    immersion in water for 4-24 hours.
        Impacts are specified on a flat anvil from a height of 2 meters and 
    on hemispherical and curbstone anvils from a height of 1.2 meters. 
    Consistent with the requirements of the ANSI, Snell, and ASTM 
    standards, the peak headform acceleration of any impact shall not 
    exceed 300 g for an adult helmet, the value originally proposed for 
    both adult and child helmets. In addition, maximum time limits of 6 
    milliseconds (``ms'') and 3 ms were originally proposed for the 
    allowable duration of the impact at the 150-g and 200-g levels, 
    respectively.
        One difference from the ANSI, ASTM, and Snell standards that was 
    originally proposed for the mandatory standard was the designation for 
    the area of the helmet that must provide impact protection. The 
    originally proposed area of impact protection for the CPSC standard was 
    reached by combining the ANSI and ASTM procedures. The procedure for 
    defining the area of the helmet subject to impact attenuation testing 
    is described at Sec. 1203.11.
        2. Children's helmets. The originally proposed mandatory standard 
    specified an increased area of head coverage for small children. A 
    study by Biokinetics & Associates Ltd. found differences in 
    anthropometric characteristics between young children's heads and older 
    children's and adult heads.6 This study led to an ASTM proposal to 
    change the position of the basic plane (an anthropometric reference 
    plane that includes the external ear openings and the bottom edges of 
    the eye sockets) on the smallest test headform to be more 
    representative of children ages 4 years and under. Originally, 
    Sec. 1203.11(b) proposed an extent-of-protection requirement for 
    helmets intended for children 4 years and under based on the adjusted 
    basic plane.
    
        \6\Heh. S., Log of ASTM F08.53 Headgear Subcommittee Meeting 
    held May 21, 1992, Date of Entry--June 17, 1992. Office of the 
    Secretary, U.S. Consumer Product Safety Commission, Washington, D.C. 
    20207.
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        3. Retention system. The dynamic strength of the retention system 
    test addresses the strength of the chin strap to ensure against 
    breakage or excessive elongation of the strap that may contribute to a 
    helmet coming off the head during an accident.
        The test requires that the chin strap remain intact and not 
    elongate more than 30 mm (1.2 inches) when subjected to a ``shock 
    load'' of a 4-kg (8.8-lb) weight falling a distance of 0.6 m (2 ft) 
    onto a steel stop anvil (see Figure 8). This test is performed on one 
    helmet under ambient conditions and on three other helmets after each 
    is subjected to one of the different hot, cold, and wet environments.
        4. Peripheral vision. Section 1203.14 of the originally proposed 
    mandatory standard requires that a helmet shall allow a field of vision 
    of 105 degrees to both the left and right of straight ahead. This 
    requirement is consistent with the ANSI, ASTM, and Snell standards.
        5. Labels and instructions. Section 1203.6 of the proposed 
    mandatory standard requires certain labels on the helmet, which are 
    consistent with all 
    
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    three U.S. voluntary standards. These labels provide the model 
    designation and warnings regarding the protective limitations of the 
    helmet. The labels also provide instructions regarding how to care for 
    the helmet and what to do if the helmet receives an impact. The labels 
    also must carry the statement ``Not for Motor Vehicle Use'' and a 
    warning that for maximum protection the helmet must be fitted and 
    attached properly to the wearer's head in accordance with the 
    manufacturer's fitting instructions.
        The proposed mandatory standard also requires that helmets be 
    accompanied by fitting and positioning instructions, including graphic 
    representation of proper positioning. As noted above, the proposed 
    mandatory standard has performance criteria for the effectiveness of 
    the retention system in keeping a helmet on the wearer's head. However, 
    these criteria may not be effective if the helmet is not well matched 
    to the wearer's head and carefully adjusted to obtain the best fit. 
    Thus, the proposed mandatory standard contains the labeling requirement 
    described above to help ensure that users will purchase the proper 
    helmet and adjust it correctly.
        To avoid damaging the helmet by contacting it with harmful common 
    substances, the helmet must be labeled with any recommended cleaning 
    agents, a list of any known common substances that will cause damage, 
    and instructions to avoid contact between such substances and the 
    helmet.
        6. Roll off. The originally proposed mandatory standard specified a 
    test procedure and requirement for the retention system's effectiveness 
    in preventing a helmet from ``rolling off'' a head. The procedure 
    specifies a dynamic impact load of a 4-kg (8.8-lb) weight dropped from 
    a height of 0.6 m (2 ft) to impact a steel stop anvil. This load is 
    applied to the edge of a helmet that is placed on a headform on a 
    support stand (see Figure 7). The helmet fails if it comes off the 
    headform during the test.
        These safety requirements, which are proposed pursuant to the 
    Bicycle Helmet Safety Act, are found in Subpart A of the proposed 
    Safety Standard for Bicycle Helmets. The comments received in response 
    to the original proposal, the Commission's responses to these comments, 
    and other changes to the original proposal are discussed in section C 
    of this notice.
        Under the authority of section 14(a) of the CPSA, the Commission 
    also proposed certification testing and labeling requirements to ensure 
    that bicycle helmets meet the standard's safety requirements. These 
    certification requirements are found in Subpart B of the proposed 
    Safety Standard for Bicycle Helmets and are discussed in section D of 
    this notice.
        Also, under the authority of section 16(b) of the CPSA, the 
    Commission proposed requirements that records be kept of the required 
    certification testing. These recordkeeping requirements are found in 
    Subpart C of the proposed Safety Standard for Bicycle Helmets and are 
    discussed in section E of this notice.
        The interim standards, which are currently codified as 16 CFR 1203, 
    will continue to apply to bicycle helmets manufactured from March 16, 
    1995, to the date that the final standard becomes effective. 
    Accordingly, the interim standards will continue to be codified, as 
    Subpart D of the standard.
        As discussed below, although the Commission is proposing certain 
    changes to the standard, the revised proposal still addresses each of 
    the elements in the original proposal.
        The Commission received 37 comments on the proposed bicycle helmet 
    standard from 30 individuals and organizations. After considering these 
    comments and other available information, the Commission decided to 
    propose certain revisions to the originally proposed standard. The 
    proposed revisions are discussed in sections C-E of this notice.
    
    C. The Revised Proposed Standard--Comments, Responses and Other 
    Changes
    
        Comment: Definition of bicycle helmet. The original proposal 
    defined bicycle helmet as ``any headgear marketed as suitable for 
    providing protection from head injuries while riding a bicycle.'' One 
    comment suggested that the definition of a product should not be in 
    terms of how it is marketed.
        Response: The Commission disagrees with this comment. It is 
    important that all products marketed as suitable for providing 
    protection from head injuries while bicycling meet the applicable 
    safety standard. However, the Commission proposes to amend the 
    definition to include not only products specifically marketed for use 
    as a bicycle helmet but also those products that can be reasonably 
    foreseen to be used for that purpose.
        Comment: Compliance with third-party standards as compliance with 
    the rule. The Snell Memorial Foundation urged that the following 
    statement be added to the certification portion of the rule that 
    describes a reasonable testing program: ``Helmets that are certified by 
    the Snell Memorial Foundation to the Snell B-95 or Snell N-94 Standards 
    are considered to be in compliance with this regulation.''
        Response: One of the objectives of the Children's Bicycle Helmet 
    Safety Act of 1994 is to establish a unified bicycle helmet safety 
    standard that is recognized nationally by all manufacturers and 
    consumers. The Commission believes it would be contrary to the intent 
    of the Act to provide that certified conformance to any particular 
    existing voluntary standard is compliance with the mandatory rule.
        Allowing third-party certification to a voluntary standard to serve 
    as compliance to the mandatory rule would not adequately deal with the 
    issue of recalls or other corrective actions if defective helmets are 
    nonetheless produced. A third party can only decertify helmets that do 
    not meet its standard and can only request that the responsible firm 
    take appropriate corrective action for previously produced helmets. 
    CPSC, on the other hand, has the authority to order a firm to take 
    corrective actions if necessary and to assess penalties where 
    appropriate. Accordingly, the Commission declines to adopt the language 
    requested by this commenter.
        Comment: Multiple-activity helmets. Some commenters recommended 
    that the CPSC include provisions for children's bicycle helmets so that 
    helmets would provide protection in activities in addition to 
    bicycling, such as skateboarding, skating, sledding, and the like. Two 
    commenters recommended that the CPSC bike helmet standard also apply to 
    helmets for roller skating and in-line skating. Other comments stated 
    that the Commission should not delay promulgation of the bike helmet 
    standard while multi-activity issues are explored.
        Response: Recent forums on head protection concluded that there is 
    a need to develop helmets that are suitable for use in a number of 
    recreational activities, not just bicycling.\7\ However, the CPSC's 
    authority under the Children's Bicycle Helmet Safety Act of 1994 is to 
    set mandatory requirements for bicycle helmets. Establishing criteria 
    for products other than bicycle helmets would require the Commission to 
    follow the procedures and make the findings 
    
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    prescribed by the CPSA or the Federal Hazardous Substances Act 
    (``FHSA'').
    
        \7\Forum on Head Protection in Recreational Sports, Harborview 
    Injury Prevention and Research Center (February 18, 1994); 
    Chairman's Roundtable, Multi-Activity Helmets, U.S. Consumer Product 
    Safety Commission (September 19, 1994).
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        In March 1994, Snell established the N-94 Standard For Protective 
    Headgear For Use in Non-Motorized Sports. This standard provides 
    greater head coverage than current bicycle helmet standards, tests for 
    multiple impacts at a single location on the helmet, and tests to see 
    if the helmet will roll off on impact. However, the Commission lacks 
    data that multiple impacts at a single location are a factor in 
    injuries to persons wearing bicycle helmets or that greater helmet 
    coverage is needed for bicycle accidents. Furthermore, the use of an 
    additional anvil in the Snell N-94 test may preclude the use of some 
    current vent designs used in bicycle helmets. The Commission is aware 
    of only a few helmets currently on the market that are certified to 
    this standard.
        Activities like roller skating, in-line skating, and skateboarding 
    are typically conducted on the same types of surfaces as bicycling and 
    can generate speeds similar to bicycling. In addition, these other 
    activities do not put the user at a higher height than when using a 
    bicycle. Thus, fall heights can be expected to be similar. It is 
    reasonable to assume that the test requirements in the bicycle helmet 
    regulation would allow the helmet to provide some protection for other 
    activities--such as in-line skating, roller skating and skateboarding--
    until multiple-activity helmets become widely available. However, the 
    Commission does not have sufficient data on the benefits and costs of 
    additional features directed at injuries incurred other than bicycling 
    to make the findings that would be required by either the CPSA or FHSA. 
    Also, procedures in addition to those required by the Bicycle Helmet 
    Safety Act would have to be followed. The Commission does not want to 
    delay establishment of a mandatory bicycle helmet standard in order to 
    pursue rulemaking for other types of helmets. Accordingly, this 
    proposed regulation only addresses bicycle helmets.
        Comment: General construction provisions. Section 1203.5 of the 
    originally proposed mandatory standard included several provisions that 
    addressed general construction characteristics of a bicycle helmet. 
    These provisions specified that helmets shall be designed to reduce the 
    acceleration forces imparted to the wearer's head by an impact and to 
    remain on the wearer's head during impact. It was also specified that 
    helmets shall be constructed not to be harmful or potentially injurious 
    to the wearer. For example, the original proposal stated that the 
    helmet surface shall not have projections that may increase the 
    likelihood of injury to the rider during an accident. In addition, the 
    original proposal provided that construction materials should be 
    resistant to environmental conditions that may be reasonably expected 
    during helmet use and storage and shall not be harmful to the wearer.
        Some commenters on the proposed rule stated that many of the 
    requirements in Sec. 1203.5 are subjective, since they have no 
    performance-related criteria. One respondent suggested that these 
    sections be located in an informative annex rather than in the body of 
    the standard.
        Response: Sections 1203.5(a) and (d) of the original proposal--
    titled ``General'' and ``Materials,'' respectively--contained no 
    objective performance criteria to establish compliance. Section 
    1203.5(c)--``Retention System''--was redundant since it merely 
    referenced test requirements elsewhere in the standard. Accordingly, 
    the Commission is eliminating these paragraphs from the revised 
    proposal.
        The first proposed standard required that external projections must 
    ``readily break away'' and internal projections shall be protected by 
    ``some means of cushioning.'' In response to the comments that this 
    language was subjective, the Commission is revising the language to 
    define more objective performance criteria. The revised requirement is 
    that the helmet be examined after impact testing to determine whether 
    there are any rigid internal projections that could contact the 
    wearer's head.
        Comment: Children's peak g-value. Some comments recommended that 
    the peak g-value for children be dropped from 300 g to 250 g or 200 g. 
    Some commenters suggested that no change be made in the g-value.
        Response: Despite the high incidence of head injury among children, 
    studies addressing mechanisms of injury and recovery are lacking. 
    Therefore, even though children make up the majority of the population 
    at risk for head injury, children's helmets sold on the market today 
    generally are designed to meet the attenuation and absorption criteria 
    established for the adult helmeted-headform drop tests. The criteria 
    for testing and evaluating the performance of helmets have been 
    established primarily on the basis of data derived from injury 
    tolerance studies conducted on adults. This is a matter of some 
    concern, since studies indicate that the type of head injury resulting 
    from blunt trauma may differ significantly between adults and children.
        The skull is the brain's primary protection against blunt force 
    trauma. The properties of the skull change significantly as a child 
    matures. Cranial capacity reaches adult size by 5 years of age. At 18 
    months, the brain has attained almost 70% of its adult size and, by 5-8 
    years, it is 90% of adult size.
        Most of the head growth beyond the first 5 years involves hardening 
    of the skull and thickening of the soft tissue around the brain. 
    Children appear to be at greater risk of diffuse brain injury because 
    their skulls have a lower degree of calcification, which provides a 
    reduced capacity to absorb an impact. This results in a greater 
    transfer of the kinetic energy from the impact site to the brain 
    tissue.
        The differences in the type of head injuries sustained by children 
    and adults should have some bearing on helmet design. Currently, no 
    compensation has been made for the differences between adults and 
    children in head injury tolerance levels regarding the bending strength 
    of the skull.
        Current United States bicycle helmet voluntary standards recommend 
    that helmets limit an attenuation impact to below 300 g in order to 
    reduce the risk of severe injury. However, for the reasons described 
    above, this may be inadequate to protect children. Published reports 
    have suggested reducing the g-value for children from 300 g to 150 to 
    250 g.8
    
        \8\Corner JP, Whitney CW, O'Rourke N, and Morgan DE. Motorcycle 
    and Bicycle Protective Helmets--Requirements. Dept. of Trans. and 
    Comm., Federal Office of Road Safety, Australia, May 1987. Lane JC. 
    Helmets for Child Bicyclists, Some Biomedical Considerations. 
    Federal Dept. of Transport, Office of Road Safety, Australia, CR 47, 
    1986.
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        A helmet may partially compensate for the flexibility of a child's 
    skull. However, the interior dimensions of the helmet will not 
    perfectly fit the skull. In an accident, point contact is likely to 
    occur between the skull and the helmet, which will tend to flex the 
    child's skull more than an adult's. Accordingly, the Commission 
    concludes that a differential in the g criteria is needed between 
    adults' and children's standards. The Commission proposes to lower the 
    g-value to 250 g. This will provide a substantial extra margin of 
    safety to account for the increased flexibility of children's skulls, 
    without making the criterion so stringent that it is either not cost 
    effective or results in helmets that are so heavy or bulky that their 
    use would be discouraged. 
    
    [[Page 62666]]
    
        Comment: Drop mass. Several commenters favored a variable drop mass 
    instead of the originally proposed 5 kg drop mass, which would have 
    been used for testing both adults' and children's helmets. (The 
    helmet's mass is not included in the drop mass.) Some respondents felt 
    a reduced drop mass is especially important for testing young 
    children's helmets. One respondent opposed lowering the drop mass, 
    stating that there is no benefit in different drop masses for each 
    headform.
        Response: A 1979 study found that in head-first free fall, a 
    child's body mass and orientation at impact have little influence on 
    head loading (g-forces) during impact.9 The study also explains 
    that head loading in adult falls is influenced by a more complex 
    relationship between head mass and body mass. This suggests that the 
    actual head mass of a child is an important factor in determining head 
    loading during impact.
    
        \9\Mohan D, Bowman B, Snyder RG, and Frost, DR. A Biomechanical 
    Analysis of Head Impact Injuries to Children. J. Biomechanical Eng. 
    101, pp. 250-260, U.S., Nov. 1979.
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        The helmet liner is designed to absorb the energy of impact by 
    deformation, and to deform at force levels below that which would cause 
    head injury. However, children's heads have less mass and their skulls 
    are more flexible than those of adults. Therefore, a child's head may 
    not deform the helmet's foam padding during impact if the foam is 
    designed to protect the heavier adult head. This lack of deformation 
    may result in greater kinetic energy being transferred to a child's 
    brain, possibly resulting in a greater likelihood of intracranial 
    injury. This strongly suggests that children's helmets should be tested 
    with a lower headform mass than helmets for adults.
        The Commission's Directorate for Epidemiology and Health Sciences 
    concluded that the head mass of children under the age of 5 years 
    ranges from approximately 2.8 to 3.9 kg. Accordingly, the Commission is 
    proposing a reduced drop assembly mass of 3.90 kg0.1 kg for 
    testing helmets for children under 5. The lower mass will better 
    represent the head mass of children under 5 years of age than the 5 kg 
    mass specified for testing helmets for older children and adults.
        Testing helmets for children under 5 years with a more appropriate 
    mass should lead to helmets that are better designed to accommodate 
    maturational differences of a young child's head. An even lower mass is 
    not feasible with current test rigs, because a drop assembly mass of 
    less than 3.90 kg would shift the center of gravity on current test 
    equipment enough to potentially influence test results.
        Comment: Extent of protection. Current U.S. voluntary bicycle 
    helmet standards, and the originally proposed CPSC standard, specify an 
    extent-of-protection boundary and an impact test line. The extent-of-
    protection boundary defines the area of the head that must be covered 
    by the helmet. The impact line designates the lowest point on the 
    helmet where the center of the anvil may be aligned for testing. A 
    clearance is specified between the extent-of-protection boundary and 
    the impact line to allow for the imprint of the test anvil.
        A number of comments on the proposed standard concerned the extent-
    of-protection (or extent of coverage) requirements. One commenter 
    stated that the extent-of-protection requirement was subjective since 
    no test is applied in these areas. Some commenters believed the 
    proposed extent-of-protection requirement was design-restrictive, since 
    some helmets have features like rear vents that may rise above the 
    extent of coverage line but nevertheless will provide protection if 
    impacted on the test line.
        Response: The Commission believes that a performance test using a 
    single test line and no extent-of-protection requirement is adequate 
    for testing the impact-attenuation capabilities of a helmet. Not 
    requiring specific helmet coverage allows manufacturers the flexibility 
    to include desirable features such as a central rear vent, provided the 
    features do not hinder the helmet's ability to meet the impact 
    requirements if tested anywhere on or above the test line. Accordingly, 
    the Commission has deleted the extent-of-protection line from the 
    revised proposed standard.
        Comment: Extended coverage for young children's helmets. A number 
    of commenters favored an extended area of coverage for young children's 
    helmets. However, one commenter suggested that the coverage lines 
    defined in the first CPSC-proposed standard were not practical, since 
    portions of the test line extended lower than the edge of an impact 
    headform.
        Response: As noted above, young children's skulls lack the 
    calcification of older children's and adult skulls. This is especially 
    true of children under 5 years old, where the curve of head growth and 
    skull development is steepest. The temporal region (area above and 
    around the ear) is much thinner than other parts of the skull. As a 
    result, a much smaller force at the temporal region can cause a serious 
    injury than at other regions of the skull. Accordingly, the Commission 
    concludes that helmets for children under 5 years should have a greater 
    area of protection than those for older children and adults.
        A recent proposal for infant helmet test lines by the ASTM Headgear 
    Subcommittee Infant/Toddler Working Group specifies a ``two-step'' test 
    line that is measured directly from the reference plane of the ISO A 
    and ISO E headforms. The Commission considers the proposed ASTM test 
    line appropriate for testing helmets for children under 5 years. The 
    revised test line (Figure 5) provides an increased area of protection, 
    including the temporal area.
        Many young children's helmets on the market already provide an area 
    of protection comparable to the revised CPSC proposal, though it is not 
    required by any current U.S. bike helmet standard. The revised CPSC 
    test line is easier to define and mark on a helmet than the first 
    proposed CPSC line, which was referenced from an adjusted basic plane 
    inclined 15 degrees from horizontal. This new test line does not extend 
    lower than the edge of the headform.
        Comment: Determining which helmets are for young children. A 
    commenter asked for clarification of how to determine whether helmets 
    are ``intended'' for children 4 years and under. The concern is that 
    small helmets are often sold to adults with small heads.
        Response: Typically, helmets for children are advertised and 
    promoted with children's themes. The Commission will consider relevant 
    factors, such as the design and marketing of a helmet, to determine 
    whether it is intended for young children.
        However, it is also important that consumers not mistake adult and 
    older children's helmets that are the same size as helmets for children 
    under 5 years of age as complying with the extra coverage and other 
    special provisions required for helmets intended for children under 5. 
    Therefore, the proposal provides that helmets specifically designed for 
    children under 5 years of age be labeled to read: ``Complies with CPSC 
    Safety Standard for Bicycle Helmets for Children Under 5 years.''
        Comment: Peripheral vision. One commenter recommended revising the 
    peripheral vision requirement to specify clearances of two separate 
    105 deg. arcs from the center of each eye.
        Response: The existing requirement of 105 deg. clearance from the 
    central point K is an established criterion that provides sufficient 
    peripheral vision and allows for helmet protective coverage to the 
    
    [[Page 62667]]
    temporal area of the head. The proposed criterion is consistent with 
    ANSI, ASTM, and Snell bicycle helmet standards, and with the FMVSS 218 
    motorcycle helmet standard. Therefore, the Commission makes no change 
    to the proposed rule in response to this comment.
        Comment: Vertical vision. One commenter suggested that the 
    Commission adopt requirements for a vertical field of vision.
        Response: The Commission has no information to indicate that 
    bicycle helmets are posing a risk of injury due to inadequate upward or 
    downward visual clearance. Accordingly, the Commission is not proposing 
    a vertical field of vision requirement.
        Comment: Dwell time. Several commenters disagreed with the dwell 
    time specification in the first proposed CPSC standard.
        Response: The Commission agrees with these comments, and the impact 
    attenuation requirements are revised to specify only peak g as the 
    evaluation criteria. This change was made because of a lack of 
    scientific evidence to support application of dwell time as a bike 
    helmet evaluation criterion.
        Comment: Point loading requirements. Two commenters recommended 
    that the Commission explore requirements to limit localized loads on 
    the head that could be caused by strategically located high-density 
    foam in helmet liners.
        Response: The Commission has no information to indicate that some 
    helmet designs may pose a risk of injury due to localized loading. 
    Therefore, the Commission is not adding point loading requirements to 
    the proposed rule at this time.
        Comment: Daytime and nighttime conspicuity. Some comments related 
    to possible requirements for helmets to improve a bicyclist's 
    conspicuity in both daytime and nighttime conditions.
        Response: Available data do not suggest that requirements to 
    increase the visibility of bicyclists to others would significantly 
    reduce daytime incidents. Data do show an increased risk of injury 
    while bicycling during non-daylight hours.
        Commission staff observed informal demonstrations which suggested 
    that reflective material on bike helmets could enhance the conspicuity 
    of a nighttime rider. However, at this time, the Commission lacks 
    information on what requirements might be effective to achieve this 
    goal.
        The Commission intends to study this issue further in conjunction 
    with planned work on evaluating the bicycle reflector requirements of 
    CPSC's mandatory requirements for bicycles. 16 CFR part 1512. After 
    that work is completed, the Commission will decide whether to propose 
    reflectivity requirements for bicycle helmets under the authority of 
    the Children's Bicycle Helmet Safety Act of 1994. The Commission does 
    not intend to delay issuance of the standard proposed in this notice to 
    coincide with any reflectivity requirements that may be issued later.
        Comment: Type of test rig. The originally proposed CPSC standard 
    and the current interim mandatory standards allow the use of either a 
    wire- or rail-guided impact test rig. A commenter recommended that the 
    Commission adopt a free-fall test rig that has no rigid connection 
    between the headform and the guide system. The Commission also received 
    a proposal from one respondent to evaluate differences between twin-
    wire and monorail test rigs through exhaustive comparison testing.
        Response: The Commission has no information to indicate that the 
    suggested free-fall rig provides a more reliable test system or that it 
    represents the dynamics of a human head impacting a surface better than 
    other types of impact test equipment. Accordingly, the Commission is 
    not proposing a free-fall test rig.
        To avoid the possibility that different results would be obtained 
    with the two types of test rigs, the Commission is specifying only the 
    monorail test rig in the revised mandatory standard. The suggested 
    tests would be helpful only if both test rigs were permitted.
        For helmet certification testing, the regulation does not require 
    that the manufacturer follow specifically the procedures of the CPSC 
    standard. Thus, a manufacturer may chose to certify helmets by testing 
    with a wire-guided test rig, provided the manufacturer assures that the 
    helmets will meet the requirements of the CPSC standard when tested on 
    the standard's monorail test rig.
        Comment: Dynamic strength of retention system test--spinning 
    rollers. A comment suggested that the ``jaw rods'' in the strength of 
    retention system test rig should be rotatable.
        Response: The requested feature is consistent with provisions in 
    both the ANSI and Canadian standards and should help ensure that the 
    maximum loading is transmitted to the retention system attachment 
    points. Accordingly, the Commission has adopted this suggestion, and 
    the revised proposal states that the ``stirrups'' that represent the 
    bone structure of the jaw shall be freely spinning cylindrical rollers.
        Comment: Dimensions of impact base. Three commenters recommended 
    revising the standard to allow a smaller impact base. The commenters 
    claimed that the dimensions specified in the proposed standard are not 
    consistent with many existing test rigs.
        Response: The Commission concludes that there is no known reason to 
    exclude bases with smaller surface dimensions. Therefore, the 
    Commission proposes to reduce the minimum surface area specification 
    from 0.30 m\2\ to 0.10 m\2\. This is consistent with impact base 
    specifications in Snell helmet standards. The minimum mass of the 
    impact base will still be the originally proposed 135 kg.
        Comment: Instrument system check procedure. One commenter claimed 
    that the instrument system check procedure specified in the first 
    proposed rule only tests repeatability and not the accuracy of 
    calibration. The commenter recommended that the procedure allow using a 
    test headform, instead of the spherical impactor, for the instrument 
    system check impacts. The commenter also suggested that the instrument 
    system check be performed at least once a week.
        Response: The commenter is correct that this instrument system 
    check procedure primarily indicates that the test is producing 
    repeatable results. The Commission's staff, using the procedures 
    proposed in the originally proposed CPSC standard, obtained daily test 
    results on an average of 12 drops of a spherical impactor on a modular 
    elastomer programmer (``MEP'') pad for 3 months. These tests yielded 
    peak accelerations that met the originally proposed 3898g 
    criteria for the specified velocity range. The specific g-level that 
    will be achieved depends on the MEP pad in use.
        The Commission agrees that the instrument system check procedure 
    should have greater flexibility to allow other laboratories to conduct 
    testing based on their internal procedures. To help assure that 
    consistent, reproducible data are obtained, the Commission proposes to 
    continue the use of an impactor with a spherical impact surface, rather 
    than impact headforms. The Commission also believes that the system 
    check interval should not be longer than the beginning and end of each 
    test day. The revised procedure, however, is not intended to prevent 
    each laboratory from exercising sound engineering practice in 
    establishing their specific methodology.
        Comment: Distance between impacts. A commenter recommends revising 
    the minimum distance between impact sites 
    
    [[Page 62668]]
    from ``one fifth the circumference of the helmet'' to 120 mm.
        Response: The Commission believes that 120 mm allows sufficient 
    distance to minimize the effects of impact site proximity and provides 
    a more straightforward measurement than the original one-fifth 
    circumference criteria. Accordingly, the Commission proposes to adopt 
    this recommendation.
        Comment: Impact velocity tolerance. One commenter suggested a 
    change from 2% to 5% for the tolerance on 
    impact velocity.
        Response: Tests by CPSC staff indicated that helmet impact 
    velocities sometimes fell outside the proposed 2% 
    tolerance. However, the impact velocities almost always were within 
    3% of the specified value. These tests showed that a 
    3% velocity tolerance is reasonable to maintain a test 
    procedure that will reliably indicate the equipment is functioning 
    properly. Accordingly, the velocity tolerance for helmet testing has 
    been changed to 3% in the revised proposal.
        Comment: Number of helmets required for testing. Comments were 
    submitted requesting clarification of the number of helmet samples 
    needed if attachments are provided with the helmet and if the helmet 
    fits two headform sizes.
        Response: An additional set of five helmets is needed for each 
    additional attachment (e.g., visors or shields), or combinations 
    thereof, sold for use with the helmet. Two additional samples per set 
    are needed if the helmet fits two headform sizes.
        Comment: Fit and testing. A comment stated that the standard needed 
    to define ``fit'' as it relates to the process of selecting a test 
    headform. Another comment provided a definition of ``fit'' and 
    suggested that the language for selecting a test headform should more 
    clearly explain how a sample set of helmets is divided when a helmet 
    fits two different headform sizes.
        Response: Language addressing these concerns, including a 
    definition of ``fit,'' has been added to the revised proposed rule.
        Comment: Wet-conditioning. A number of commenters suggested that 
    wet-conditioning by totally immersing the helmet in water is 
    unrealistically severe. These commenters recommended that the 
    Commission consider a water-spray environment.
        Response: Commission testing of both immersed and water-sprayed 
    helmets under various time durations showed no consistent trend in 
    resulting peak acceleration levels. The immersion environment has the 
    advantages of being easier to define and of subjecting the helmet to a 
    uniform conditioning exposure. Since testing showed that these 
    commenters' concerns are unfounded, the Commission is retaining the 
    immersion method of wet-conditioning in the proposed standard. However, 
    additional specifications to standardize the wet environment are 
    included.
        Comment: Anvil test schedule. In the originally proposed standard, 
    helmets 1 through 4 would have been tested with the flat and 
    hemispherical anvils and the fifth helmet would be tested with the 
    curbstone anvil. Two commenters suggested that there is no reason for a 
    curbstone anvil impact to be treated differently from the flat and 
    hemispherical anvil impacts.
        Response: Each anvil has a unique ``imprint'' that could stress 
    helmet designs differently. Therefore, the proposed standard has been 
    revised so that each of test helmets 1 through 4 must meet the 
    standard's impact criteria on four impacts, once with each of the three 
    anvils and once with the anvil likely to result in the highest g-value. 
    In the absence of an indication why another anvil would be more 
    stringent, this fourth impact should be made with the anvil that 
    produced the highest g-value in the previous three impacts. This is 
    consistent with the test schedules of the Snell B-90(S), N-94, and B-95 
    helmet standards. (Under the revised proposal, the fifth helmet is 
    tested only for positional stability.)
        Comment: Helmet straps. A commenter recommended that the test 
    procedure require that all slack be removed from the helmet straps when 
    fastening the helmet to the test headform.
        Response: The Commission agrees with this comment and has revised 
    the proposal accordingly.
        Comment: Lateral positional stability test. A commenter recommended 
    the addition of a positional stability test in the lateral direction.
        Response: The shape of the head is such that a properly fitted 
    helmet is more likely to come off to the front or rear than to the 
    side. Accordingly, the suggested lateral positioning test is 
    unnecessary and not proposed.
        Comment: Dynamic v. static-load positional stability test. One 
    commenter suggested that the CPSC consider the static load positional 
    stability test specified in the Canadian Standards Association ('CSA') 
    bicycle helmet standard.
        Response: The Commission believes that a dynamic test provides a 
    more rigorous and realistic test of the restraint system, and has not 
    adopted this suggested change.
        Comment: Retention system test schedule. Some commenters asked that 
    the CPSC consider a change to the test schedule so that at least one 
    impact attenuation drop per sample would be performed prior to testing 
    the retention system.
        Response: CPSC staff testing did not show evidence to warrant a 
    change in the sequence of retention system strength tests and impact 
    tests. Accordingly, the Commission did not make this suggested change.
        Comment: Use of a Rubber Pad on the Stop Anvil. One commenter 
    recommended using a rubber pad between the steel drop mass and the stop 
    anvil.
        Response: The current ASTM and ANSI bicycle helmet standards do not 
    require a rubber pad on the stop anvil. Based on comparison testing 
    with and without a rubber pad, the Commission believes a rubber pad may 
    produce a somewhat less stringent test. In the absence of any 
    compelling reason to allow a rubber pad, therefore, the Commission has 
    not changed the original proposal in this regard.
        Comment: Self-release buckle. One commenter suggested that 
    consideration be given to requirements for a self-release buckle that 
    could be used to prevent strangulation if the helmet becomes caught. 
    The commenter stated that there are now efforts in Europe to develop a 
    test method that would ensure that buckles release or break away when 
    subjected to a load equivalent to the weight of a child.
        Response: The Commission has received reports of eight or nine 
    deaths of children in Sweden and Norway that occurred when helmets 
    became caught in trees or playground equipment, causing the child to 
    become suspended by the chin strap. The Commission also has received 
    reports of four nonfatal incidents in the United States since 1990, 
    involving children of ages from 5 through 7 years, that occurred in the 
    same fashion.
        However, the Commission is not proposing requirements for a self-
    release buckle at this time. Considering the frequency and potential 
    severity of head injuries in bicycle accidents, it is important to 
    ensure that the helmet retention strength requirements are not 
    compromised.
        Comment: Use labeling. A number of comments concerned what 
    information should be on a bike helmet label to inform consumers of the 
    helmet's intended use. Some commenters favored the ``Not For Motor 
    Vehicle Use'' label that was first proposed in the CPSC standard. 
    Others felt the helmet should be labeled ``For Bicycle Use Only.'' 
    
    [[Page 62669]]
    
        Response: Currently, the ANSI and Snell voluntary standards require 
    the label ``For Bicycle Use Only.'' ASTM requires the label ``Not for 
    Motor Vehicle Use.'' The ASTM label was originally proposed because 
    helmets are currently not made specifically for many non-bicycling 
    activities, and people should not be discouraged from using a helmet 
    for such activities by a label that states it is for bicycle use 
    only.10
    
        \10\In fact, despite the ``For bicycle use only'' label, the 
    U.S. Amateur Confederation of Roller Skating adopted the ANSI and 
    Snell helmet standards years ago for use in competitive roller 
    skating.
    ---------------------------------------------------------------------------
    
        Other commenters, however, disagreed. One indicated that labeling 
    ``Not for Motor Vehicle Use'' would stifle the development of separate 
    helmet standards for other sports by voluntary organizations. The 
    commenter believed that the ``Not for Motor Vehicle Use'' label 
    suggests that a bicycle helmet is as effective for any non-motorized 
    use as a helmet designed specifically for that activity.
        The Commission has no evidence to support the contention that the 
    ASTM label would inhibit the development of voluntary standards for 
    non-motorized activities, and no evidence that a bicycle helmet is 
    inadequate for some of these activities. For this reason, the 
    Commission continues to propose the ASTM label, ``Not for Motor Vehicle 
    Use.''
        Comment: Label language and format. Some commenters suggested that 
    the labels have specific language and format (e.g., the ANSI Warning 
    Format).
        Response: The Commission concludes that requiring specific language 
    or format is inappropriate for bicycle helmet labels, because the 
    variety of helmet styles and limited space on the interior of some 
    helmets requires more flexibility in labeling.
        Comment: Fit information on box. One commenter recommended that 
    information on how to properly fit a helmet be required on the outside 
    of the box.
        Response: Children frequently report uncomfortable fit as a reason 
    for not wearing a helmet all the time. It is reasonable to expect that 
    improper fit was sometimes involved in complaints that helmets are 
    uncomfortable. A label on the box could inform parents, before they buy 
    the helmet, that they need to properly fit it to the child's head. 
    However, the Commission is not aware of any information which indicates 
    that such a label would be any more effective in assuring proper fit in 
    use than the originally proposed instructions, which need not be on the 
    box. Accordingly, the Commission did not adopt this requested change.
        Comment: Age-specific fit instructions. A commenter suggested that 
    instructions on fitting a helmet be age-specific, so that a young child 
    can read them.
        Response: The Commission believes that age-specific instructions 
    are unnecessary. The Commission lacks data showing that young children 
    would act on age-specific instructions without urging from their 
    parents. The originally proposed rule requires that the instruction 
    sheet have graphics showing proper fit and position of the helmet. 
    Children who can read may well be able to understand pictures showing 
    proper fit. If not, the involvement of parents will likely be needed to 
    convey the information on how to fit the helmet. Parents reading along 
    with the child and discussing the pictures will likely deliver the 
    message of proper fit.
        Comment: Life of helmets. One commenter was concerned that the 
    requirement of Sec. 1203.6(a) that labels be legible for the life of 
    the helmet was indefinite, because the life of a helmet is not known.
        Response: Snell N-94 and B-95 helmet standards recommend that 
    helmets be replaced after 5 years, or less if the manufacturer so 
    recommends. The Commission concludes that the manufacturer or importer 
    can determine the life of a particular helmet and assure that the 
    labels will remain legible for that time. However, to make this 
    requirement more definite, the Commission has amended the proposal to 
    state that the labels shall remain legible for the intended design life 
    of the helmet.
        Comment: Helmet label--post-impact instructions. Some commenters 
    requested that more direct information be provided about what to do 
    with a helmet that has received an impact. One respondent stated that 
    the current wording--``after receiving an impact, the helmet should be 
    returned to manufacturer or be destroyed and replaced''--is ambiguous.
        Response: Damage to a helmet from an impact is not always visible 
    to the user. To describe on a label the circumstances in which helmets 
    can be used again, can be fixed, or should be destroyed, if feasible at 
    all, would make the label excessively wordy and likely to be skimmed or 
    ignored. Therefore, the Commission concludes that the most specific and 
    appropriate label would state that the helmet be returned to the 
    manufacturer or destroyed after impact because any damage may not be 
    visible to the user.
        Comment: Neck injury protection. One commenter requested that the 
    Commission include in this Federal Register notice a statement 
    encouraging helmet manufacturers to ``undertake the development and 
    marketing of helmets that protect wearers from paralyzing neck injuries 
    as a result of bicycle riding.'' The commenter referred to a report 
    that indicates that bike helmets reduce the risk of head injury, but do 
    not seem to have any effect in reducing the risk of serious neck 
    injury.
        Response: The Commission is aware of some efforts to reduce the 
    risks of serious neck injury to bicyclists and participants in other 
    recreational activities. The Commission always encourages research and 
    development of safety-related devices. The Commission's staff will 
    continue to monitor progress in this area. However, such devices are 
    beyond the scope of this proceeding.
        Other changes to the standard:
        1. Impact-attenuation test--support assembly mass. The 
    specification that the mass of the support assembly be no greater than 
    25 percent of the mass of the total drop assembly has been deleted. The 
    boundary on the location for the center of gravity at 
    Sec. 1203.17(a)(3) will adequately limit the mass variance between the 
    support assembly and the headform assembly.
        2. Dynamic strength of retention system test--mass of the test rig. 
    The ASTM F1446 standard specifies a support assembly mass in the range 
    of 6 kg to 12 kg (including the drop mass). CPSC considered this range 
    too wide when developing the first CPSC proposed standard and specified 
    a mass of 6 kg with a tight tolerance of  0.5 kg. 
    Subsequent consideration of this issue by the ASTM Headgear 
    Subcommittee concluded that the assembly mass, excluding the drop 
    weight, should be specified at 7 kg (11 kg including the drop weight) 
    with a narrow tolerance. It was agreed that this rig applies a rigorous 
    test of retention system strength and provides a system better suited 
    for adapting an electronic displacement transducer to provide an 
    accurate means for measuring elongation. Accordingly, the mass of the 
    test rig has been revised to 11 kg  0.5 kg.
        3. Dynamic strength of retention system test--deletion of preload 
    ballast procedure. The procedure to place a preload ballast on top of 
    the helmet has been deleted, since the more massive test rig in the 
    revised proposal applies a sufficient preload to the helmet retention 
    system to set the helmet fit padding against the test headform. 
    
    [[Page 62670]]
    
        4. Children's helmets--age range. The age break for special 
    provisions for children's helmets was originally proposed for 
    ``children 4 years of age and under.'' The Commission has revised this 
    language to ``children under 5 years of age.'' This language clarifies 
    the intent to include children until they reach their fifth birthday.
        5. Older children and adults test line. The Commission is proposing 
    a revised test line for adults' and older children's helmets, as shown 
    in Figure 4. The portion of the test line that extends from the front 
    of the headform and through its center portion is essentially the test 
    line specified in the Snell B-90 standard. Compared to the test lines 
    in other U.S. voluntary bike helmet standards to which bike helmets are 
    currently certified, the Snell B-90 test line provides the greatest 
    area of impact protection in the front and central portions of the 
    head.
        The rear step in the revised CPSC test line is derived by using a 
    20 mm clearance from the extent-of-protection boundary specified in the 
    August 15, 1994, CPSC-proposed bike helmet standard. The revised test 
    region provides an acceptable area of head protection while allowing 
    for certain design flexibility.
        6. Definition of Helmet Positioning Index (``HPI''). In the 
    originally proposed standard, the HPI is defined as a distance that 
    locates where the brow of the helmet should be positioned on the 
    headform. In the revised proposal, the HPI is defined (Sec. 1203.4(f)) 
    to be a specified distance from the reference plane (defined at 
    Sec. 1203.4(l) and Figure 3), rather than from the basic plane (defined 
    at Sec. 1203.4(a) and Figures 1 and 2). This change is made because 
    impact headforms are cut away (above the basic plane) at the front brow 
    area, making it difficult to measure for the HPI from the basic plane.
    
    D. Certification Testing and Labeling
    
        General. Section 14(a) of the CPSA, 15 U.S.C. 2063(a), requires 
    that every manufacturer (including importers) and private labeler of a 
    product that is subject to a consumer product safety standard issue a 
    certificate that the product conforms to the applicable standard, and 
    to base that certificate either on a test of each product or on a 
    ``reasonable testing program.'' Subpart B of the proposed Safety 
    Standard for Bicycle Helmets contains these certification requirements.
        The originally proposed certification rule. The proposed 
    certification rule would require manufacturers of bicycle helmets that 
    are manufactured 1 year after the issue date of the final standard to 
    affix permanent labels to the helmets. These labels would be the 
    ``certificates of compliance,'' as that term is used in Sec. 14(a) of 
    the CPSA. In the rule as originally proposed, all helmets would have 
    had a label stating ``Complies with CPSC Safety Standard for Bicycle 
    Helmets (16 CFR 1203)''. As explained below, the Commission is 
    proposing somewhat different language for this label.
        In some instances, the label on the bicycle helmet may not be 
    immediately visible to the ultimate purchaser of the helmet prior to 
    purchase because of packaging or other marketing practices. In those 
    cases, it is proposed to advise consumers that the helmet meets the 
    CPSC standard by a second label that would be on the helmet's container 
    or, if the container is not visible, on the promotional material used 
    in connection with the sale of the bicycle helmet.
        The proposed certification label also contains the name and address 
    of the manufacturer or importer, and identifies the production lot and 
    the month and year the product was manufactured. Some of the required 
    information may be in code.
        The proposed certification rule requires manufacturers and 
    importers to conduct a reasonable testing program to demonstrate that 
    their bicycle helmets comply with the requirements of the standard. 
    This reasonable testing program may be defined by the manufacturers, 
    but must include either the tests prescribed in the standard or any 
    other reasonable test procedures that assure compliance with the 
    standard.
        The originally proposed certification rule provides that the 
    required testing program will test bicycle helmets sampled from each 
    production lot in such a manner that there is a reasonable assurance 
    that, if the bicycle helmets selected for testing meet the standard, 
    all bicycle helmets in the lot will meet the standard.
        The rule as originally proposed provided that bicycle helmet 
    importers may rely in good faith on the foreign manufacturer's 
    certificate of compliance, provided that a reasonable testing program 
    has been performed by or for the foreign manufacturer; the importer is 
    a U.S. resident or has a resident agent in the U.S.; and the required 
    test records are kept in the U.S. As explained in section E below, the 
    Commission proposes an exception to the requirement that test records 
    must be kept in the U.S.
        Comments, responses, and other changes to the certification testing 
    and labeling requirements.
        Comment: Production lot. One commenter stated that the rule should 
    use ``frequency of production'' rather than the originally proposed 
    ``manufacturing lot'' method to define a lot. The commenter explained 
    that a manufacturing lot may encompass well over a million helmets if 
    there are no changes in the design and production of a helmet. The 
    commenter further explained that using frequency of production as the 
    basis of the required reasonable testing program would require a firm 
    to test after a specified number of helmets are produced. The commenter 
    believes this would catch any defects more readily.
        Another commenter stated that the production lot should be based on 
    a monthly or yearly period, as a production lot could include helmets 
    made well after the qualification testing.
        Another commenter stated that the proposed definition of a 
    production lot is unmanageable and may be expensive if a large number 
    of helmets is produced and if there are any variations in the materials 
    or processes in the production of the helmets. The commenter recommends 
    that the definition of production lot be changed to either 
    ``sequentially labeled helmets bonded and tested separately, or a 
    continuous production of like models produced in accordance with a 
    quality system ensuring traceability for all component parts.'' Comment 
    CC94-2-25.
        In addition, a commenter stated that CPSC should allow 
    manufacturers flexibility to establish their own recognized quality 
    assurance program, such as Mil Std 105D, ISO 9000, or ASQC.
        Response: The proposed rule defines a ``production lot'' as ``a 
    quantity of bicycle helmets from which certain bicycle helmets are 
    selected for testing before certifying the lot.'' In the proposed 
    regulation, the helmets in a lot must be essentially identical in 
    design, construction, and materials. This definition of a production 
    lot does not require the lot to be a specified number of helmets or a 
    set time interval of helmet production, such as weekly or monthly. 
    However, the definition in the proposed regulation does not prohibit 
    certification based on testing after a specified number of helmets or 
    period of time, provided that changes in the design, construction, or 
    materials of the helmet are not made in that production lot. Firms must 
    define their production lots in such a fashion that samples collected 
    for testing represent all the bicycle helmets in a particular lot.
        The firms responsible for certification know their products and 
    manufacturing processes. These firms are in the best 
    
    [[Page 62671]]
    position to define their production lot and set up a reasonable testing 
    program in order to assure that their helmets meet the standard. 
    Furthermore, testing on only a number or time basis could allow changes 
    in the helmets' specifications during a production lot that might cause 
    failing results to go undetected until the specified interval occurs. 
    Accordingly, the Commission is not proposing to require testing after a 
    specified number of helmets or time period of production.
        A firm is not restricted in any way from establishing its own 
    quality control program, including programs based on Mil Std. 105D, ISO 
    9000, or ASQC. Therefore, no change in the proposal is required in this 
    regard.
        The Commission believes that the certifying firms can determine, 
    based on their production lot and methods of manufacture, how best to 
    sample their lot in order to insure that the helmets meet the standard.
        Comment: Sampling. A commenter stated that the testing program 
    should provide for sampling over the entire production lot in order to 
    discover the production of noncomplying helmets.
        Response: Under the proposed rule, there is no requirement that 
    sampling be conducted over the entire production lot. The rule states 
    that the manufacturers and importers may set up their own testing 
    program, provided the program is reasonable. The testing program is to 
    insure that the helmets selected for testing represent all the helmets 
    in the production lot. For the guidance of certifying firms, however, 
    the Commission notes that a reasonable testing program would include 
    both prototype and production testing, to provide reasonable assurance 
    that all of the bicycle helmets in the production lot being tested 
    comply with the requirements of the standard.
        Comment: Certification label. A commenter inquired whether the 
    content of the certification label could be divided among more than one 
    label.
        Response: The originally proposed regulation did not address 
    whether the placement should be on one label. However, the restricted 
    space inside helmets requires that there be flexibility for the format 
    of the certification labeling.
        The Commission's Division of Human Factors believes that the name 
    and address of the manufacturer, private labeler, or importer, where 
    required and not in code, should be on one label. This is so the 
    consumer can associate the address with the name if it is necessary to 
    contact the manufacturer, private labeler, or importer for repair or 
    replacement of the helmet. Also, if it is too difficult to find the 
    information, consumers are less likely to follow through with repair or 
    replacement of helmets. Accordingly, the Commission is revising the 
    proposal to require that the name and address of firms required to be 
    identified uncoded on the label must be on the same label.
        However, the Commission now proposes to allow separate labels for 
    the other required information, including the statement of compliance 
    with the CPSC standard, the production lot, and the date of 
    manufacture.
        Comment: Third-party testing. A commenter suggested that 
    certification testing should be conducted by a third party and include 
    off-the-shelf random testing.
        Response: Under the proposed rule, testing may be done by the 
    manufacturer or importer or by a third party. Regardless of who 
    performs the test, certifying firms are responsible for insuring 
    compliance with all requirements of the standard. No data are available 
    showing that third-party certification would improve compliance with 
    the standard. Accordingly, there is no reason to change the proposal in 
    that regard.
        Comment: Verification by CPSC. A commenter suggested that the 
    quality control testing program, testing equipment, and calibration of 
    the testing equipment should be verified by CPSC.
        Response: It would be an inefficient use of Commission resources to 
    conduct either quality control verification or calibration of industry 
    equipment, and the need to do this has not been demonstrated. 
    Accordingly, the proposal is unchanged in this regard.
        Comment: Production testing of features unlikely to change. A 
    commenter stated that, once a model is certified, testing of helmets 
    for peripheral vision, labeling, and instructions are unnecessary when 
    performing routine compliance testing.
        Response: The proposal allows each firm to establish its own 
    testing program, provided the testing program is reasonable. No 
    specific tests are required. When there have not been any changes in 
    the design of the helmet, the firm may establish simple visual 
    examination of some attributes of helmets. For example, if the 
    manufacturer is assured that there has been no change in the physical 
    dimensions of a helmet, there would be no need to retest the helmet's 
    peripheral vision.
        No change to the proposal is required to accommodate this 
    commenter's concern.
        Comment: Certification label content--coding of foreign 
    manufacturer. A commenter complained that the true name of the foreign 
    manufacturer could be coded and not disclosed.
        Response: The intent of the certification label is to identify a 
    party that the consumer or the CPSC can contact concerning the safety 
    of a helmet. In addition, consumers need to be able to contact someone 
    in the U.S. for repair or replacement information. Since foreign 
    manufacturers are not subject to this regulation, there is no need for 
    consumers to know the identity of the foreign manufacturer. 
    Accordingly, the importer may code the foreign manufacturer's name. 
    Similarly, a private labeler may code the U.S. manufacturer or both the 
    importer and foreign manufacturer.
        The identification of the coded information must be available upon 
    request from the importer or private labeler whose name is required to 
    appear on the certification label. This adequately protects the 
    interests the consumer and the CPSC have in this information. In 
    addition, consumers could be confused if two firms were identified on 
    the label. Accordingly, no change to the proposal is made in this 
    regard.
        Comment: Certification label content--age of helmet. A commenter 
    stated that permitting the coding of the product lot number and the 
    date of manufacture denies consumers important information on the age 
    of their helmets, as manufacturers commonly recommend replacing the 
    helmet after 5 years. The commenter contends also that it would be 
    easier for consumers to recognize recalls of helmets identified by 
    dates on the helmets rather than by other codes.
        Response: Under the proposed rule, the manufacturer, importer, or 
    private labeler may code the production lot and the date of production. 
    These codes on the helmets should not place an undue burden on the 
    consumer in determining the date of manufacture, as this information 
    can be obtained if necessary.
        Manufacturers recommend that helmets be replaced after 5 years of 
    use. The manufacture date or code would not identify the ``use'' age of 
    the helmet, which relates more to the date of purchase of the helmet.
        During recalls, the affected firms will identify the model of the 
    helmet, any codes, where it was sold, and the dates of distribution. A 
    consumer can readily ascertain if his/her helmet is being recalled by 
    examining the model number and the date of manufacture, which may be 
    coded. Having the manufacturing date coded would not 
    
    [[Page 62672]]
    interfere with identifying a recalled helmet. Accordingly, no change in 
    the proposal is needed in this regard.
        Comment: Certification label content--date of manufacture, serial 
    number, and test date. One firm wants to provide the date of 
    manufacture, serial number, and test date on the helmet, rather than a 
    production lot.
        Response: The proposed regulation requires the production lot and 
    the month and year of manufacture to be identifiable from the label, 
    but does not require or prohibit the serial number or test date. Both 
    the production lot and the time of manufacture may be in code. The test 
    date would not add any information for the consumer. The serial number, 
    however, may serve as a code to identify the production lot and, if so, 
    may be used in its place.
        Accordingly, the proposed rule has been revised to state that a 
    serial number may be used in place of a production lot identification 
    if it can serve as a code to identify the production lot.
        Comment: Certification label content--telephone number. A commenter 
    contends that the telephone number of the responsible firm should be on 
    the certification label.
        Response: A telephone number is not required. This might place a 
    burden on small firms with insufficient staff to handle a large number 
    of calls. The consumer can contact the responsible firm in writing if 
    the need arises.
        Other change: Compliance labels. Section 14(a) of the CPSA requires 
    that certifying firms issue a certificate certifying that the product 
    conforms to all applicable consumer product safety standards. 15 U.S.C. 
    2063(a). Accordingly, the original proposal would have required the 
    label statement ``Complies with CPSC Safety Standard for Bicycle 
    Helmets (16 CFR part 1203)''.
        The Commission wants to guard against the possibility that small 
    adult helmets will be purchased for children. Therefore, the revised 
    proposed standard requires that helmets that do not comply with the 
    requirements for young children's helmets be labeled ``Complies with 
    CPSC Safety Standard for Bicycle Helmets for Adults and Children Age 5 
    and Older (16 CFR 1203)''. Helmets intended for children 4 years of age 
    and younger would bear a label stating ``Complies with CPSC Safety 
    Standard for Bicycle Helmets for Children Under 5 Years (16 CFR 
    1203)''. Helmets that comply with both standards could be labeled 
    ``Complies with the CPSC Safety Standard for Bicycle Helmets for 
    Persons of All Ages'', or equivalent language.
    
    E. Recordkeeping
    
        Section 16(b) of the CPSA requires that: [e]very person who is a 
    manufacturer, private labeler, or distributor of a consumer product 
    shall establish and maintain such records, make such reports, and 
    provide such information as the Commission may reasonably require for 
    the purposes of implementing this Act, or to determine compliance with 
    rules or orders prescribed under this Act.
    
    15 U.S.C. 2065(b).
        The rule as originally proposed would have required every entity 
    issuing certificates of compliance for bicycle helmets to maintain 
    written records that show the certificates are based on a reasonable 
    testing program. As explained below, the Commission proposes to relax 
    the requirement that the records be kept in written form.
        These records were proposed to be maintained for a period of at 
    least 3 years from the date of certification of the last bicycle helmet 
    in each production lot and shall be available to any designated officer 
    or employee of the Commission upon request in accordance with 
    Sec. 16(b) of the CPSA, 15 U.S.C. 2065(b).
        Comment: Location of test records. The original proposal required 
    that records be kept by the importer in the U.S. to allow inspection by 
    CPSC staff within 48 hours of a request by an employee of the 
    Commission. A commenter inquired whether test records must be kept in 
    the U.S. in the case of a Canadian firm that is owned by a U.S. firm, 
    if the records are available to the U.S. company upon request.
        Response: The situation described by the commenter would achieve 
    the result desired by the Commission. Accordingly, the Commission has 
    revised the proposed regulation to state that if the importer can 
    provide the records to the CPSC staff within the 48-hour time period, 
    the records will be considered kept in the U.S.
        Comment: Records on disk. The proposed regulation stated that every 
    person issuing a certificate of compliance for bicycle helmets shall 
    maintain written records that show certificates are based on a 
    reasonable testing program. A commenter requested that the 
    certification test records be allowed to be kept on disk instead of 
    paper.
        Response: The Commission agrees with the commenter that firms 
    should be allowed to keep the records on disk, if the records can be 
    made available upon request in an appropriate format. Accordingly, the 
    Commission has amended the proposal to state that certification test 
    record results may be kept on paper, microfiche, computer disk, or 
    other retrievable media. Where records are kept on computer disk or 
    other retrievable media, the records shall be made available to the 
    Commission upon request on paper copies, or via electronic mail in the 
    same format as paper copies.
    
    F. Regulatory Flexibility Act Certification
    
        When an agency undertakes a rulemaking proceeding, the Regulatory 
    Flexibility Act, 5 U.S.C. 601 et seq., generally requires the agency to 
    prepare proposed and final regulatory flexibility analyses describing 
    the impact of the rule on small businesses and other small entities.
        The purpose of the Regulatory Flexibility Act, as stated in section 
    2(b) (5 U.S.C. 602 note), is to require agencies, consistent with their 
    objectives, to fit the requirements of regulations to the scale of the 
    businesses, organizations, and governmental jurisdictions subject to 
    the regulations. Section 605 of the Act provides that an agency is not 
    required to prepare a regulatory flexibility analysis if the head of an 
    agency certifies that the rule will not have a significant economic 
    impact on a substantial number of small entities.
        The Commission's Directorate for Economics has prepared a 
    preliminary economic assessment of the safety standard for bicycle 
    helmets. The proposed rule would establish performance requirements for 
    bicycle helmets. The vast majority of helmets now sold conform to one 
    (or more) of three existing voluntary standards. The one-time costs 
    associated with the redesign and testing of helmets to the new 
    performance standards are not known. On a per-unit basis, however, 
    costs associated with redesign and testing are expected to be small. 
    The Commission solicits comment on the costs of the redesign and 
    testing of bicycle helmets that would be required by the proposed 
    standard.
        The vast majority of manufacturers now use third party testing and 
    monitoring for product liability reasons, and are likely to continue to 
    do so in the future. The proposed standard allows for self 
    certification and monitoring, however, which is substantially less 
    costly than third party testing and monitoring.
        The proposed labeling requirement is unlikely to have a significant 
    impact on small firms, since virtually all bicycle helmets now bear a 
    permanent label on their inside surface. Industry sources 
    
    [[Page 62673]]
    report that, given sufficient lead time to modify these labels, any 
    increased cost of labeling would be insignificant.
        Accordingly, for the reasons given above, the Commission 
    preliminarily certifies that the proposed Safety Standard for Bicycle 
    Helmets, if promulgated, will not have any significant economic effect 
    on a substantial number of small entities.
    
    G. Environmental Considerations
    
        Pursuant to the National Environmental Policy Act, and in 
    accordance with the Council on Environmental Quality regulations and 
    CPSC procedures for environmental review, the Commission has assessed 
    the possible environmental effects associated with the proposed safety 
    standard for bicycle helmets.
        The Commission's regulations at 16 CFR 1021.5(c)(1) and (2) state 
    that safety standards and product labeling or certification rules for 
    consumer products normally have little or no potential for affecting 
    the human environment. Preliminary analysis of the potential impact of 
    this proposed rule indicates that the rule is not expected to affect 
    preexisting packaging or materials of construction now used by 
    manufacturers. Existing inventories of finished products would not be 
    rendered unusable, since section 9(g)(1) of the CPSA provides that 
    standards apply only to products manufactured after the effective date. 
    Changes in coverage areas for helmets may require modification or 
    replacement of existing injection molds. However, molds are routinely 
    replaced due to wear or to changes in style, and modified molds could 
    be incorporated in this replacement process. Thus, the quantity of 
    discarded molds attributable to the rule is likely to be small. 
    Especially in view of the statutory 1-year effective date, it is 
    unlikely that significant stocks of current labels would require 
    disposal.
        The requirements of the standard are not expected to have a 
    significant effect on the materials used in production or packaging, or 
    on the amount of materials discarded due to the regulation. Therefore, 
    no significant environmental effects are expected from the proposed 
    rule if it is adopted. Accordingly, neither an environmental assessment 
    nor an environmental impact statement is required.
    
    H. Paperwork Reduction Act
    
        As noted above, the requirements proposed below, if issued as a 
    final rule, would require U.S. manufacturers and importers of bicycle 
    helmets to conduct a reasonable testing program to ensure their 
    products comply with the standard. They are also required to keep 
    records of such testing so that the Commission's staff can verify that 
    the testing was conducted properly. This will enable the staff to 
    obtain information indicating that a company's helmets comply with the 
    standard, without having itself to test helmets. U.S. manufacturers and 
    importers of bicycle helmets would also have to label their products 
    with specified information.
        For these reasons, the proposal published below contains 
    ``collection of information requirements'' subject to the Paperwork 
    Reduction Act of 1995, 15 U.S.C. 3501-3520, Pub. L. 104-13, 109 Stat. 
    163 (1995). An agency may not conduct or sponsor, and a person is not 
    required to respond to, a collection of information unless it displays 
    a currently valid OMB control number. The control number may be 
    displayed by publication in the Federal Register. Accordingly, the 
    Commission has submitted the proposed collection of information 
    requirements to OMB for review under section 3507(d) of the Paperwork 
    Reduction Act of 1995. The title of the submission is ``Safety Standard 
    for Bicycle Helmets--Testing and Recordkeeping Requirements.''
        The Commission's staff estimates that there are about 30 
    manufacturers and importers subject to these collection of information 
    requirements. There are an estimated 200 different models of bicycle 
    helmets currently marketed in the U.S.
        Industry sources advise the Commission's staff that the time that 
    will be required to comply with the collection of information 
    requirements will be from 100 to 150 hours per model per year. 
    Therefore, the total amount of time required for compliance with these 
    requirements will be 20,000 to 30,000 hours per year. However, these 
    estimates are based on the amount of time that is currently expended in 
    complying with the similar requirements that are in the various 
    voluntary standards. Thus, the net burden of the proposed final 
    collection of information requirements is expected to be insignificant, 
    or at least a small fraction of the total hours given above. The 
    Commission would like to receive comments on the activities and time 
    required to comply with these requirements and how these differ from 
    usual and customary current industry practices, on the accuracy of the 
    Commission's burden estimate, and on how that burden could be reduced.
        It is possible that firms will consider some of the records 
    required to be provided to the Commission upon request to be trade 
    secret or other confidential commercial information. Under section 
    6(a)(2) of the CPSA, the Commission may not disclose information that 
    contains or relates to a trade secret, or is of a type referred to in 
    18 U.S.C. 1905 or subject to 5 U.S.C. 552(b)(4). 15 U.S.C. 2055(a)(2). 
    Under this section and 16 CFR 1015.18-.19, persons desiring 
    confidential treatment for information must request that it not be 
    disclosed. If the Commission's staff nevertheless determines that the 
    information may be disclosed because it is not confidential, the person 
    submitting the information will be given written notice at least 10 
    working days before the information is released. Thus, the submitter 
    has an opportunity to seek judicial review of the Commission's 
    determination before the information is released. Also, see 16 CFR part 
    1101. These procedures also apply to rulemaking comments for which the 
    commenter seeks confidentiality.
        Any person may also submit comments to OMB on these proposed 
    collection of information requirements. OMB is required to make a 
    decision concerning the collections of information contained in the 
    proposed rule between 30 and 60 days after publication. Thus, although 
    comments will be received by OMB until February 5, 1996, a comment to 
    OMB is best assured of having its full effect if OMB receives it by 
    January 5, 1996. Comments should be submitted to the Office of 
    Information and Regulatory Affairs of OMB, Attention: Desk Officer for 
    the Consumer Product Safety Commission. Persons filing comments with 
    OMB are encouraged to send copies to the Commission's Office of the 
    Secretary, with a caption or cover letter identifying the materials as 
    comments submitted to OMB on the proposed collection of information 
    requirements for bicycle helmets.
    
    List of Subjects in 16 CFR Part 1203
    
        Consumer protection, Bicycles, Incorporation by reference, Infants 
    and children, Safety.
        For the reasons given above, the Commission proposes to revise Part 
    1203 of Title 16 of the Code of Federal Regulations, to read as 
    follows:
    
    PART 1203--SAFETY STANDARD FOR BICYCLE HELMETS
    
    Subpart A--The Standard
    
    Sec.
    1203.1  Scope and effective date.
    1203.2  Purpose.
    1203.3  Referenced documents.
    1203.4  Definitions.
    1203.5  Construction requirements - projections.
    1203.6  Labeling and instructions. 
    
    [[Page 62674]]
    
    1203.7  Samples for testing.
    1203.8  Conditioning environments.
    1203.9  Test headforms.
    1203.10  Selecting the test headform.
    1203.11  Marking the test line.
    1203.12  Test requirements.
    1203.13  Test schedule.
    1203.14  Peripheral vision test.
    1203.15  Positional stability test (roll-off resistance).
    1203.16  Dynamic strength of retention system test.
    1203.17  Impact attenuation test.
    1203.18  Reflectivity. [Reserved]
    
    Subpart B--Certification
    
    1203.30  Purpose and scope.
    1203.31  Effective date.
    1203.32  Definitions.
    1203.33  Certification testing.
    1203.34  Product certification and labeling by manufacturers 
    (including importers).
    
    Subpart C--Recordkeeping
    
    1203.40  Effective date.
    1203.41  Recordkeeping requirements.
    Subpart D--Bicycle Helmets Manufactured From March 16, 1995, Through 
    Date That Is 1 Year After The Final Rule Is Issued
    1203.51  Purpose.
    1203.52  Scope and effective date.
    1203.53  Interim safety standards.
    
    Figures to Part 1203
    
        Authority: Secs. 201-207, Pub. L. 103-267, 108 Stat. 726-729, 15 
    U.S.C. 6001-6006.
    
    Subpart A--The Standard
    
    
    Sec. 1203.1  Scope and effective date.
    
        This standard describes test methods and defines minimum 
    performance criteria for protective headgear used by bicyclists. The 
    values stated in International System of Units (``SI'') measurements 
    are the standard. The inch-pound values stated in parentheses are for 
    information only. The standard shall become effective 1 year after 
    publication of the final rule and shall apply to all bicycle helmets 
    manufactured after that date. Bicycle helmets manufactured between 
    March 16, 1995, and the date that is 1 year after publication of the 
    final rule, inclusive, are subject to the requirements of Subpart D, 
    rather than this Subpart A.
    
    
    Sec. 1203.2  Purpose.
    
        The purpose and basis of this standard is to reduce the likelihood 
    of serious injury and death to bicyclists resulting from impacts to the 
    head, as provided in 15 U.S.C. 6001-6006.
    
    
    Sec. 1203.3  Referenced documents.
    
        The following documents are referenced in this standard.
        (a) Draft ISO/DIS Standard 6220-1983--Headforms for Use in the 
    Testing of Protective Helmets.1
    
        \1\Available from American National Standards Institute, 11 W. 
    42nd St., 13th Floor, New York, NY 10036.
    ---------------------------------------------------------------------------
    
        (b) Federal Motor Vehicle Safety Standard 218, Motorcycle 
    Helmets.2
    
        \2\Available from the Department of Transportation, National 
    Highway Traffic Safety Administration, Office of Vehicle Safety 
    Standards, 400 7th St. S.W., Washington D.C. 20590.
    ---------------------------------------------------------------------------
    
        (c) SAE Recommended Practice SAE J211 OCT88, Instrumentation for 
    Impact Tests.3
    
        \3\Available from Society of Automotive Engineers, 400 
    Commonwealth Dr., Warrendale, PA 15096.
    ---------------------------------------------------------------------------
    
    
    Sec. 1203.4  Definitions
    
        (a) Basic plane means an anatomical plane that includes the 
    auditory meatuses (the external ear openings) and the inferior orbital 
    rims (the bottom edges of the eye sockets). The ISO headforms are 
    marked with a plane corresponding to this basic plane (see Figures 1 
    and 2 to this part).
        (b) Bicycle helmet means any headgear that either is marketed as, 
    or has a reasonably foreseeable use as, a device intended to provide 
    protection from head injuries while riding a bicycle.
        (c) Comfort or fit padding means resilient lining material used to 
    configure the helmet for a range of different head sizes. This padding 
    has no significant effect on impact attenuation.
        (d) Coronal plane is an anatomical plane perpendicular to both the 
    basic and midsagittal planes and containing the midpoint of a line 
    connecting the right and left auditory meatuses. The ISO headforms are 
    marked with a transverse plane corresponding to this coronal plane (see 
    Figures 1 and 2).
        (e) Field of vision is the angle of peripheral vision allowed by 
    the helmet when positioned on the reference headform.
        (f) Helmet positioning index (HPI) is the vertical distance from 
    the brow of the helmet to the reference plane, when placed on a 
    reference headform. The vertical distance shall be specified by the 
    manufacturer for each size of headform the helmet fits.
        (g) Midsagittal plane is an anatomical plane perpendicular to the 
    basic plane and containing the midpoint of the line connecting the 
    notches of the right and left inferior orbital ridges and the midpoint 
    of the line connecting the superior rims of the right and left auditory 
    meatuses. The ISO headforms are marked with a longitudinal plane 
    corresponding to the midsagittal plane (see Figures 1 and 2 to this 
    part).
        (h) Modular elastomer programmer (MEP) is a cylindrical pad, 
    typically consisting of a polyurethane rubber, used as a consistent 
    impact medium for the systems check procedure.
        (i) Preload ballast is a ``bean bag'' filled with lead shot placed 
    on the helmet to secure its position on the headform. The mass of the 
    preload ballast is 5 kg (11 lb).
        (j) Projection is any part of the helmet, internal or external, 
    that extends beyond the faired surface.
        (k) Reference headform is a headform used as a measuring device and 
    contoured in the same configuration as one of the test headforms A, E, 
    J, M, and O defined in DRAFT ISO DIS 6220-1983. The reference headform 
    shall include surface markings corresponding to the basic, coronal, 
    midsagittal, and reference planes (see Figures 1 and 2 to this part).
        (l) Reference plane is a plane marked on the ISO headforms at a 
    specified distance above and parallel to the basic plane (see Figure 3 
    to this part).
        (m) Retention system is the complete assembly that secures the 
    helmet in a stable position on the wearer's head.
        (n) Shield means optional equipment for helmets that is used in 
    place of goggles to protect the eyes.
        (o) Spherical impactor is a 146 mm (5.75 in.) diameter aluminum 
    sphere, with a mass of 4005  5 g (8.83  1.10 
    lb), that is specifically machined for mounting onto the ball-arm 
    connector of the drop-test assembly. The impactor is used to check the 
    electronic equipment (see Sec. 1203.17).
        (p) Test headform is a solid model in the shape of a human head of 
    sizes A, E, J, M, and O as defined in DRAFT ISO/DIS 6220-1983. 
    Headforms used for the impact attenuation test shall be constructed of 
    K-1A magnesium alloy or functionally equivalent metal. The test 
    headforms shall include surface markings corresponding to the basic, 
    coronal, midsagittal, and reference planes (see Figure 2 to this part).
        (q) Test region is the area of the helmet, on and above a specified 
    test line, that is subject to impact testing.
        (r) Visor (peak) is optional helmet equipment for protection 
    against sun or glare, and is sometimes used as a rock or dirt 
    deflector.
    
    
    Sec. 1203.5  Construction requirements--projections.
    
        Any unfaired projection extending more than 7 mm (0.28 in.) from 
    the helmet's outer surface shall break away or collapse when impacted 
    with forces equivalent to those produced by the applicable impact-
    attenuation tests in Sec. 1203.17 of this standard. Rigid 
    
    [[Page 62675]]
    projections on the inner surface shall not exceed 2 mm (0.08 in.) and 
    shall not make contact with the test headform after testing in 
    accordance with Sec. 1203.17.
    
    
    Sec. 1203.6  Labeling and instructions.
    
        (a) Labeling. Each helmet shall be marked so that the following 
    information is legible and easily visible to the user and is likely to 
    remain on the helmet and legible throughout the intended design life of 
    the helmet:
        (1) Model designation.
        (2) A warning to the user that no helmet can protect against all 
    possible impacts.
        (3) A warning that for maximum protection the helmet must be fitted 
    and attached properly to the wearer's head in accordance with the 
    manufacturer's fitting instructions.
        (4) A warning to the user that the helmet may, after receiving an 
    impact, be damaged to the point that it is no longer adequate to 
    protect the head against further impacts, and that this damage may not 
    be visible to the user. This label shall also state that a helmet that 
    has sustained an impact should be returned to the manufacturer for 
    competent inspection, or be destroyed and replaced.
        (5) A warning to the user that the helmet can be damaged by contact 
    with common substances (for example, certain solvents, cleaners, etc.), 
    and that this damage may not be visible to the user. This label shall 
    also state any recommended cleaning agents and procedures, list any 
    known common substances that damage the helmet, and warn against 
    contacting the helmet with these substances.
        (6) The statement ``Not For Motor Vehicle Use''.
        (b) Instructions. Each helmet shall have fitting and positioning 
    instructions, including graphic representation of proper positioning.
    
    
    Sec. 1203.7  Samples for testing.
    
        (a) General. Helmets shall be tested in the condition in which they 
    are offered for sale. They must pass all tests, both with and without 
    any attachments that may be offered by the helmet's manufacturer, and 
    with all possible combinations of such attachments.
        (b) Number of samples. Five samples of each size for each model and 
    combination of attachments offered for sale are required to test 
    conformance to this standard. If a helmet fits more than one size of 
    test headform, two additional samples are needed for each additional 
    headform size for the testing described in Sec. 1203.10--Selecting the 
    test headform.
    
    
    Sec. 1203.8  Conditioning environments.
    
        Helmets shall be conditioned to one of the following environments 
    prior to testing in accordance with the test schedule at Sec. 1203.13. 
    The barometric pressure in all conditioning environments shall be 75 to 
    110 kPa (22.2 to 32.6 inches of Hg). All test helmets shall be 
    stabilized within this ambient range for at least 4 hours prior to 
    further conditioning and testing. Storage or shipment within this 
    ambient range satisfies this requirement.
        (a) Ambient condition. The ambient condition of the test laboratory 
    shall be within 17  deg.C to 27  deg.C (63  deg.F to 81  deg.F), and 20 
    to 80 percent relative humidity. The ambient test helmet does not need 
    further conditioning.
        (b) Low temperature. The helmet shall be kept at a temperature of 
    -16  deg.C to -13  deg.C (3  deg.F to 9  deg.F) for 4 to 24 hours prior 
    to testing.
        (c) High temperature. The helmet shall be kept at a temperature of 
    47  deg.C to 53  deg.C (117  deg.F to 127  deg.F) for 4 to 24 hours 
    prior to testing.
        (d) Water immersion. The helmet shall be fully immersed ``crown'' 
    down in potable water at a temperature of 17  deg.C to 27  deg.C (63 
    deg.F to 81  deg.F) to a crown depth of 305 mm25 mm (12 
    in.1 in.) for 4 to 24 hours prior to testing.
    
    
    Sec. 1203.9  Test headforms.
    
        The headforms used for testing shall be sizes A, E, J, M, and O, as 
    defined by DRAFT ISO/DIS 6220-1983. Headforms used for impact testing 
    shall be constructed of K-1A magnesium alloy or other functionally 
    equivalent metal and must have no resonant frequencies below 3000 hz.
    
    
    Sec. 1203.10  Selecting the test headform.
    
        A helmet shall be tested on the appropriate size(s) of headform(s) 
    on which it fits. Fit means that it is not physically difficult to put 
    the helmet on the headform, and that the helmet's comfort or fit 
    padding is partially compressed. A complete set of five helmets of each 
    size and model shall be tested on the smallest size test headform on 
    which they fit. Two additional helmets shall be tested on each of the 
    larger headforms the helmets fit. Testing on the larger headform(s) 
    will include at least one peripheral vision test, dynamic retention 
    test, positional stability test, and impact attenuation test (complete 
    set of four impacts) using the conditioning environment that produced 
    the highest g value in the impact attenuation tests on the smallest 
    headform the helmet fit.
    
    
    Sec. 1203.11  Marking the test line.
    
        Prior to testing, the test line shall be determined for each helmet 
    in the following manner.
        (a) Position the helmet on the appropriate headform as specified by 
    the manufacturer's head positioning index (HPI), with the brow parallel 
    to the basic plane. Place a 5-kg (11-lb) preload ballast on top of the 
    helmet to set the comfort or fit padding.
        (b) Draw a test line on the outer surface of the helmet coinciding 
    with the intersection of the surface of the helmet with the impact line 
    planes defined from the reference headform as shown in:
        (1) Figure 4 to this part for helmets intended for adults and for 
    children 5 years of age and older.
        (2) Figure 5 for helmets intended for children under 5 years of 
    age.
        (c) The center of the impact sites shall be selected at any point 
    on the helmet on or above the test line.
    
    
    Sec. 1203.12  Test requirements.
    
        (a) Peripheral vision. The helmet shall allow unobstructed vision 
    through a minimum of 105 deg. to the left and right sides of the 
    midsagittal plane when measured in accordance with Sec. 1203.14 of this 
    standard.
        (b) Positional stability. The helmet shall not release from the 
    test headform when tested in accordance with Sec. 1203.15 of this 
    standard.
        (c) Dynamic strength of retention system. The retention system 
    shall remain intact without elongating more than 30 mm (1.2 in.) when 
    tested in accordance with Sec. 1203.16 of this standard.
        (d) Impact attenuation criteria. (1) For bicycle helmets intended 
    for adults and children 5 years and older. The peak acceleration of any 
    impact shall not exceed 300 g when the helmet is tested in accordance 
    with Sec. 1203.17 of this standard.
        (2) For bicycle helmets intended for children under 5 years. The 
    peak acceleration of any impact shall not exceed 250 g when the helmet 
    is tested in accordance with Sec. 1203.17 of this standard.
    
    
    Sec. 1203.13  Test schedule.
    
        (a) One of the set of five helmets shall be tested for peripheral 
    vision in accordance with Sec. 1203.14 of this standard.
        (b) Helmet samples 1 through 4 shall be conditioned in the ambient, 
    high temperature, low temperature, and water immersion environments, 
    respectively. Helmet 5 shall be conditioned in the ambient condition.
        (c) Testing must begin within 2 minutes after the helmet is removed 
    
    
    [[Page 62676]]
    from the conditioning environment. The helmet shall be returned to the 
    conditioning environment within 3 minutes after it was removed for a 
    minimum of 2 minutes before testing is resumed. If the helmet is out of 
    the conditioning environment for longer than 3 minutes, it shall be 
    reconditioned for 5 minutes for each minute it is out of the 
    conditioning environment beyond the allotted 3 minutes before testing 
    is resumed.
        (d) Helmets shall be tested for dynamic strength of the retention 
    system prior to being tested for impact attenuation. Helmets 1 through 
    4 (conditioned in ambient, high temperature, low temperature, and water 
    immersion environments) shall be tested in accordance with the dynamic 
    retention system strength test at Sec. 1203.16. Helmets 1 through 4 
    shall then be tested in accordance with the impact attenuation tests on 
    the flat, hemispherical, and curbstone anvils in accordance with the 
    procedure at Sec. 1203.17. Helmet 5 (conditioned in an ambient 
    environment) shall be tested in accordance with the positional 
    stability tests at Sec. 1203.15. Table 1203.13 summarizes the test 
    schedule.
    
                                              Table 1203.13.--Test Schedule                                         
    ----------------------------------------------------------------------------------------------------------------
                                                                                                      Sec. 1203.17  
                                                  Sec. 1203.14     Sec. 1203.15     Sec. 1203.16    Impact tests--4 
                                                   Peripheral       Positional       Retention        impacts per   
                                                     vision         stability     system strength        helmet     
    ----------------------------------------------------------------------------------------------------------------
    Helmet 1--Ambient.........................  X                ...............  X                1 Flat  X        
                                                                                                   1Hemi.  X        
                                                                                                   1 Curb.  X       
                                                                                                   1 TBD*  X        
    Helmet 2--High Temperature................  ...............  ...............  X                1 Flat  X        
                                                                                                   1 Hemi.  X       
                                                                                                   1 Curb.  X       
                                                                                                   1 TBD*   X       
    Helmet 3--Low Temperature.................  ...............  ...............  X                1 Flat  X        
                                                                                                   1 Hemi.  X       
                                                                                                   1 Curb.  X       
                                                                                                   1 TBD*  X        
    Helmet 4--Water Immersion.................  ...............  ...............  X                1 Flat  X        
                                                                                                   1 Hemi.  X       
                                                                                                   1 Curb.  X       
                                                                                                   1 TBD*  X        
    Helmet 5--Ambient.........................  X                X                                                  
    ----------------------------------------------------------------------------------------------------------------
    * To Be Determined. The fourth impact can be on any of the anvils, at the discretion of the test personnel.     
    
    Sec. 1203.14.  Peripheral vision test.
    
        Position the helmet on a reference headform in accordance with the 
    HPI and place a 5-kg (11-lb) preload ballast on top of the helmet to 
    set the comfort or fit padding. (Note: Peripheral vision clearance may 
    be determined when the helmet is positioned for marking the test 
    lines.) Peripheral vision is measured horizontally from each side of 
    the midsagittal plane around the point K (see Figure 6 to this part). 
    Point K is located on the front surface of the reference headform at 
    the intersection of the basic and midsagittal planes. The vision shall 
    not be obstructed within 105 degrees on each side of the midsagittal 
    plane from point K.
    
    
    Sec. 1203.15  Positional stability test (roll-off resistance).
    
        (a) Test equipment. (1) Headforms. The geometry of the test 
    headforms shall comply with the dimensions of the full chin ISO 
    reference headforms sizes A, E, J, M, and O.
        (2) Test fixture. The headform shall be secured in a test fixture 
    with its vertical axis pointing downward and 45 degrees to the 
    direction of gravity (see Figure 7 to this part). The test fixture 
    shall permit rotation of the headform about its vertical axis and 
    include means to lock the headform in the face up and face down 
    positions.
        (3) Dynamic impact apparatus. A dynamic impact apparatus shall be 
    used to apply a shock load to a helmet secured to a test headform. The 
    dynamic impact apparatus shall allow a 4-kg (8.8-lb) drop weight to 
    slide in a guided free fall to impact a rigid stop anvil (see Figure 
    7). The entire mass of the dynamic impact assembly, including the drop 
    weight, shall be no more than 5 kg (11 lb).
        (4) Strap or cable. A hook and flexible strap or cable shall be 
    used to connect the dynamic impact apparatus to the helmet. The strap 
    or cable shall be of a material having an elongation of no more than 5 
    mm (0.20 in.) per 300 mm (11.8 in.) when loaded with a 22-kg (48.5 lb) 
    weight in a free hanging position.
        (b) Test procedure. (1) Orient the headform so that its face is 
    down, and lock it in that orientation.
        (2) Place the helmet on the appropriate size full chin headform in 
    accordance with the HPI and fasten the retention system in accordance 
    with the manufacturer's instructions. Adjust the straps to remove any 
    slack.
        (3) Suspend the dynamic impact system from the helmet by 
    positioning the flexible strap over the helmet along the midsagittal 
    plane and attaching the hook over the edge of the helmet as shown in 
    Figure 7.
        (4) Raise the drop weight to a height of 0.6 m (2 ft) from the stop 
    anvil and release it, so that it impacts the stop anvil.
        (5) The test shall be repeated with the headform face pointing 
    upwards, so that the helmet is pulled from front to rear.
    
    
    Sec. 1203.16  Dynamic strength of retention system test.
    
        (a) Test equipment. (1) ISO headforms without the lower chin 
    portion shall be used.
        (2) The retention system strength test equipment shall consist of a 
    dynamic impact apparatus that allows a 4-kg (8.8-lb) drop weight to 
    slide in a guided free fall to impact a rigid stop anvil (see Figure 
    8). Two cylindrical rollers that spin freely, with a diameter of 
    12.50.5 mm (0.49 in.0.02 in.) that have a 
    center-to-center distance of 76.01 mm (3.00.04 
    in.), shall make up a stirrup that represents the bone structure of the 
    
    
    [[Page 62677]]
    lower jaw. The entire dynamic test apparatus hangs freely on the 
    retention system. The entire mass of the support assembly, including 
    the 4-kg (8.8-lb) drop weight, shall be 11 kg0.5 kg (24.2 
    lb1.1 lb).
        (b) Test procedure. (1) Place the helmet on the appropriate size 
    headform on the test device according to the HPI. Fasten the strap of 
    the retention system under the stirrup.
        (2) Mark the pre-test position of the retention system, with the 
    entire dynamic test apparatus hanging freely on the retention system.
        (3) Raise the 4-kg (8.8-lb) drop weight to a height of 0.6 m (2 ft) 
    from the stop anvil and release it, so that it impacts the stop anvil.
        (4) Record the maximum elongation of the retention system during 
    the impact. A marker system or a displacement transducer, as shown in 
    Figure 8, are two methods of measuring the elongation.
    
    
    Sec. 1203.17  Impact attenuation test.
    
        (a) Test instruments and equipment. (1) Measurement of impact 
    attenuation. Impact attenuation is determined by measuring the 
    acceleration of the test headform during impact. Acceleration is 
    measured with a uniaxial accelerometer that is capable of withstanding 
    a shock of at least 1000 g. The helmet is secured onto the headform and 
    dropped in a guided free fall, using a monorail test apparatus (see 
    Figure 9), onto an anvil fixed to a rigid base. The base shall consist 
    of a solid mass of at least 135 kg (298 lb), the upper surface of which 
    shall consist of a steel plate at least 12 mm (0.47 in.) thick and 
    having a surface area of at least 0.10 m\2\ (1.08 ft\2\).
        (2) Accelerometer. A uniaxial accelerometer is mounted at the 
    center of gravity of the test headform, with the sensitive axis aligned 
    within 5 degrees of vertical when the test headform is in the impact 
    position. The acceleration data channel and filtering shall comply with 
    SAE Recommended Practice J211 OCT88, Instrumentation for Impact Tests, 
    Requirements for Channel Class 1000.
        (3) Headform and drop assembly--centers of gravity. The center of 
    gravity of the test headform is located at the center of the mounting 
    ball on the support assembly and lies within an inverted cone with its 
    axis vertical, and forming a 10 degree included angle with the vertex 
    at the point of impact. The location of the center of gravity of the 
    drop assembly (combined test headform and support assembly) must meet 
    FMVSS 218 S7.1.8. The center of gravity of the drop assembly lies 
    within the rectangular volume bounded by x = -6.4 mm (-0.25 in.), x = 
    21.6 mm (0.85 in), y = 6.4 mm (0.25 in.), and y = -6.4 mm (-0.25 in), 
    with the origin located at the center of gravity of the test headform. 
    The rectangular volume has no boundary along the z-axis. The x-y-z axes 
    are mutually perpendicular and have positive or negative designations 
    in accordance with the right-hand rule. The origin of the coordinate 
    axes is located at the center of the mounting ball on the support 
    assembly. The x-y-z axes of the test headform assembly on monorail 
    impact-test equipment are oriented as follows: From the origin, the x-
    axis is horizontal with its positive direction going toward and passing 
    through the vertical centerline of the monorail. The positive z-axis is 
    downward. The y-axis also is horizontal, and its direction is decided 
    by the z- and x-axes, using the right-hand rule. See Figure 10 for an 
    overhead view of the x-y boundary of the location of the center of 
    gravity.
        (4) Drop assembly. The center of gravity of the headform shall be 
    at the center of the mounting ball.
        (i) Mass of the drop assembly for testing helmets for adults and 
    children 5 years of age and older. The combined mass of the 
    instrumented test headform and support assembly (excluding the test 
    helmet) for the impact test shall be 5.0 0.1 kg (11.00 
    0.22 lb).
        (ii) Mass of the drop assembly for testing helmets for children 
    under 5 years. The combined mass of the instrumented test headform (ISO 
    A or ISO E) and support assembly (excluding the test helmet) for the 
    impact test shall be 3.9 0.1 kg (8.60 0.22 lb).
        (5) Impact anvils. Impact tests shall be performed against the 
    three different anvils described below. All of the anvils shall be 
    constructed of steel and shall be solid (i.e., without internal 
    cavities).
        (i) Flat Anvil. The flat anvil shall have a flat surface area with 
    an impact face having a minimum diameter of 125 mm (4.92 in.) and shall 
    be at least 24 mm (0.94 in.) thick (see Figure 11).
        (ii) Hemispherical anvil. The hemispherical anvil shall have an 
    impact surface with a radius of 48 1 mm (1.89 
    0.04 in.). The profile of the impact surface shall be one 
    half the surface of a sphere (see Figure 12).
        (iii) Curbstone anvil. The curbstone anvil shall have two flat 
    faces making an angle of 105 degrees and meeting along a striking edge 
    with a radius of 15 mm 0.5 mm (0.59 0.02 in.). 
    The height of the curbstone anvil shall not be less than 50 mm (1.97 
    in.), and the length shall not be less than 200 mm (7.87 in.) (see 
    Figure 13).
        (b) Test Procedure. (1) Instrument system check. The impact-
    attenuation test instrumentation shall be checked before and after each 
    series of tests (at least at the beginning and end of each test day) by 
    dropping an impactor with a spherical impact surface onto an 
    elastomeric test medium (MEP). The impactor shall be dropped onto the 
    MEP at a specified impact velocity (2% of a central value) 
    that is representative of helmet testing drop heights. Before 
    conducting a series of drops, the center vertical axis of the 
    accelerometer (see Sec. 1203.17(a)(2)) shall be aligned with the 
    geometric center of the MEP pad. Six impacts, at intervals of 75 
    15 seconds, shall be performed at the beginning and end of 
    the day. The first three impacts at the beginning and end of the day 
    shall be considered warm-up drops and shall be discarded from the 
    series. The test parameters selected at each laboratory shall produce 
    impact accelerations shown to be repeatable within 2% of a 
    central value.
        (2) Impact sites. Each of helmets 1 through 4 (one helmet for each 
    conditioning environment) shall impact at four different sites, one 
    impact on the flat anvil, one impact on the hemispherical anvil, one 
    impact on the curbstone anvil, and one impact on an anvil chosen at the 
    discretion of the test personnel.4 The center of any impact may be 
    on or anywhere above the test line, provided it is at least 120 mm 
    (4.72 in), measured on the surface of the helmet, from any prior impact 
    center. Rivets and other mechanical fasteners, vents, and any other 
    helmet feature within the test region are valid test sites.
    
        \4\The intent of this requirement is that the fourth impact will 
    be on the anvil likely to result in the highest g-value. In the 
    absence of an indication why another anvil would be more stringent, 
    this fourth impact should be made with the anvil that produced the 
    highest g-value in the previous three impacts.
    ---------------------------------------------------------------------------
    
        (3) Impact velocity. The helmet shall be dropped onto the flat 
    anvil from a theoretical drop height of 2 meters (6.56 ft) to achieve 
    an impact velocity of 6.2 m/s 3% (20.34 ft/s 
    3%). The helmet shall be dropped onto the hemispherical and 
    curbstone anvils from a theoretical drop height of 1.2 meters (3.94 ft) 
    to achieve an impact velocity of 4.8 m/s 3% (15.75 ft/s 
    3%). The impact velocity shall be measured during the last 
    40 mm (1.57 in) of free-fall for each test.
        (4) Helmet position. Prior to each test, the helmet shall be 
    positioned on the test headform in accordance with the HPI. The helmet 
    shall be secured so that it does not shift position prior to impact. 
    The helmet retention system shall be secured in a manner that does not 
    interfere with free-fall or impact. 
    
    [[Page 62678]]
    
        (5) Data. Record the maximum acceleration in g's during impact.
    
    
    Sec. 1203.18  Reflectivity. [Reserved]
    
    Subpart B--Certification
    
    
    Sec. 1203.30  Purpose and scope.
    
        (a) Purpose. Section 14(a) of the Consumer Product Safety Act 
    (CPSA), 15 U.S.C. 2063(a), requires every manufacturer (including 
    importers) and private labeler of a product which is subject to a 
    consumer product safety standard to issue a certificate that the 
    product conforms to the applicable standard. Section 14(a) further 
    requires that the certificate be based either on a test of each product 
    or on a ``reasonable testing program.'' The purpose of this subpart is 
    to establish requirements that manufacturers and importers of bicycle 
    helmets subject to the Safety Standard for Bicycle Helmets (Subpart A 
    of this Part 1203) shall issue certificates of compliance in the form 
    specified.
        (b) Scope. The provisions of this subpart apply to all bicycle 
    helmets that are subject to the requirements of the Safety Standard for 
    Bicycle Helmets.
    
    
    Sec. 1203.31  Effective date.
    
        Any bicycle helmet manufactured more than 1 year after publication 
    of a final rule must meet the standard and must be certified as 
    complying with the standard in accordance with this Subpart B.
    
    
    Sec. 1203.32  Definitions.
    
        The following definitions shall apply to this subpart:
        (a) Foreign manufacturer means an entity that manufactured a 
    bicycle helmet outside the United States.
        (b) Manufacturer means the entity that either manufactured a helmet 
    in the United States or imported a helmet manufactured outside the 
    United States.
        (c) Private labeler means an owner of a brand or trademark that is 
    used on a bicycle helmet subject to the standard and which is not the 
    brand or trademark of the manufacturer of the bicycle helmet, provided 
    the owner of the brand or trademark caused, authorized, or approved its 
    use.
        (d) Production lot means a quantity of bicycle helmets from which 
    certain bicycle helmets are selected for testing prior to certifying 
    the lot. All bicycle helmets in a lot must be essentially identical in 
    those design, construction, and material features that relate to the 
    ability of a bicycle helmet to comply with the standard.
        (e) Reasonable testing program means any tests which are identical 
    or equivalent to, or more stringent than, the tests defined in the 
    standard and which are performed on one or more bicycle helmets 
    selected from the production lot to determine whether there is 
    reasonable assurance that all of the bicycle helmets in that lot comply 
    with the requirements of the standard.
    
    
    Sec. 1203.33  Certification testing.
    
        (a) General. Manufacturers, as defined in Sec. 1203.32(a), shall 
    conduct a reasonable testing program to demonstrate that their bicycle 
    helmets comply with the requirements of the standard.
        (b) Reasonable testing program. This paragraph provides guidance 
    for establishing a reasonable testing program.
        (1) Manufacturers and importers may define their own reasonable 
    testing programs. Reasonable testing programs may, at the option of 
    manufacturers and importers, be conducted by an independent third party 
    qualified to perform such testing programs. However, manufacturers, as 
    defined in Sec. 1203.32(a), are responsible for insuring compliance 
    with all requirements of this standard.
        (2) To conduct a reasonable testing program, the bicycle helmets 
    shall be divided into production lots. Sample bicycle helmets from each 
    production lot shall be tested in accordance with the reasonable 
    testing program. Whenever there is a change in parts, suppliers of 
    parts, or production methods that could affect the ability of the 
    bicycle helmet to comply with the requirements of the standard, the 
    manufacturer shall establish a new production lot for testing.
        (3) The Commission will test for compliance with the standard by 
    using the standard's test procedures. However, a reasonable testing 
    program need not be identical to the tests prescribed in the standard.
        (4) If the reasonable testing program shows that a bicycle helmet 
    may not comply with one or more requirements of the standard, no 
    bicycle helmet in the production lot can be certified as complying 
    until all noncomplying bicycle helmets in the lot have been identified 
    and destroyed or altered by repair, redesign, or use of a different 
    material or components to the extent necessary to make them conform to 
    the standard.
        (5) The sale or offering for sale of a bicycle helmet that does not 
    comply with the standard is a prohibited act and a violation of 
    Sec. 19(a) of the CPSA (15 U.S.C. 2068(a)), regardless of whether the 
    bicycle helmet has been validly certified.
    
    
    Sec. 1203.34  Product certification and labeling by manufacturers 
    (including importers).
    
        (a) Form of permanent label of certification. Manufacturers, as 
    defined in Sec. 1203.32(a), shall issue certificates of compliance for 
    bicycle helmets manufactured after the effective date of the standard 
    in the form of a legible and readily visible label which can reasonably 
    be expected to remain on the bicycle helmet and legible for the 
    intended design life of the helmet. Such labeling shall be deemed to be 
    a certificate of compliance, as that term is used in Sec. 14 of the 
    CPSA, 15 U.S.C. 2063.
        (b) Contents of certification label. The certification labels 
    required by this section shall contain the following:
        (1) The statement ``Complies with CPSC Safety Standard for Bicycle 
    Helmets for Adults and Children Age 5 and Older (16 CFR 1203)'' or 
    ``Complies with CPSC Safety Standard for Bicycle Helmets for Children 
    Under 5 Years (16 CFR 1203)'', as appropriate (for a helmet that meets 
    the criteria for both an adult helmet and a helmet for children under 
    age 5, the label may state ``Complies with the CPSC Safety Standard for 
    Bicycle Helmets for Persons of All Ages'', or equivalent language);
        (2) The name of the U.S. manufacturer or importer responsible for 
    issuing the certificate;
        (3) The address of the U.S. manufacturer or importer responsible 
    for issuing the certificate or, if the name of a private labeler is on 
    the label, the address of the private labeler;
        (4) The name and address of the foreign manufacturer, if the helmet 
    was manufactured outside the United States;
        (5) An identification of the production lot; and
        (6) The month and year the product was manufactured.
        (c) Coding. (1) The information required by paragraphs (b) (4) 
    through (6) of this section may be in code, provided:
        (i) the person or firm issuing the certificate maintains a written 
    record of the meaning of each symbol used in the code, and
        (ii) the record shall be made available to the distributor, 
    retailer, consumer, and Commission upon request.
        (2) A serial number may be used in place of a production lot 
    identification on the helmet if it can serve as a code to identify the 
    production lot. If a bicycle helmet is manufactured for sale by a 
    private labeler, and if the name of the private labeler is on the 
    certification label, the name of the manufacturer or importer issuing 
    the certificate, and the name and address of any foreign 
    
    [[Page 62679]]
    manufacturer, may also be in such a code.
        (d) Placement of the label(s). The information required by 
    paragraphs (b) (2) through (3) must be on one label, unless allowed to 
    be in code. The other required information may be on separate labels. 
    The label(s) required by this section must be affixed to the bicycle 
    helmet. If the label(s) are not immediately visible to the ultimate 
    purchaser of the bicycle helmet prior to purchase because of packaging 
    or other marketing practices, a second label is required. That label 
    shall state, as appropriate, ``Complies with CPSC Safety Standard for 
    Bicycle Helmets for Adults and Children Age 5 and Older'', or 
    ``Complies with CPSC Safety Standard for Bicycle Helmets for Children 
    Under 5 Years''. The additional label must appear on the container or, 
    if the container is not visible before purchase, on the promotional 
    material used with the sale of the bicycle helmet. (For a helmet that 
    meets the criteria for both an adult helmet and a helmet for children 
    under age 5, the label may state ``Complies with the CPSC Safety 
    Standard for Bicycle Helmets for Persons of All Ages'', or equivalent 
    language.)
        (e) Additional provisions for importers.
        (1) General. The importer of any bicycle helmet subject to the 
    standard in Subpart A of this Part 1203 must issue the certificate of 
    compliance required by Sec. 14(a) of the CPSA and this section.
        (i) If a reasonable testing program meeting the requirements of 
    this subpart has been performed by or for the foreign manufacturer of 
    the product, the importer may rely in good faith on such tests to 
    support the certificate of compliance provided:
        (A) the importer is a resident of the United States or has a 
    resident agent in the United States,
        (B) the records of such tests required by Sec. 1203.41 of Subpart C 
    of this part are maintained in the United States, and
        (C) such records are available to the Commission upon request to 
    the importer.
        (ii) Test records may be maintained outside of the United States if 
    they will be provided to the Commission within 48 hours of a request 
    for the records.
        (2) Responsibility of importer. If the importer relies on tests by 
    the foreign manufacturer to support the certificate of compliance, the 
    importer shall--in addition to complying with paragraph (e(1)of this 
    section--examine the records supplied by the manufacturer to determine 
    that they comply with Sec. 1203.41 of Subpart C of this part.
    
    Subpart C--Recordkeeping
    
    
    Sec. 1203.40  Effective date.
    
        The recordkeeping requirements in this subpart are effective [1 
    year after publication of the final rule] and apply to bicycle helmets 
    manufactured after that date.
    
    
    Sec. 1203.41  Recordkeeping requirements.
    
        (a) General. Every person issuing certificates of compliance for 
    bicycle helmets subject to the standard in Subpart A of this part shall 
    maintain records which show that the certificates are based on a 
    reasonable testing program. The records shall be maintained for a 
    period of at least 3 years from the date of certification of the last 
    bicycle helmet in each production lot. These records shall be 
    available, upon request, to any designated officer or employee of the 
    Commission, in accordance with Sec. 16(b) of the CPSA, 15 U.S.C. 
    2065(b).
        (b) Contents of records. Complete test records shall be maintained. 
    Records shall contain the following information.
        (1) An identification of the bicycle helmets tested;
        (2) An identification of the production lot;
        (3) The results of the tests, including the precise nature of any 
    failures;
        (4) A description of the specific actions taken to address any 
    failures;
        (5) A detailed description of the tests;
        (6) The manufacturer's name and address;
        (7) The model and size of each helmet tested;
        (8) Identifying information for each helmet tested, including the 
    production lot for each helmet, and the environmental condition under 
    which each helmet was tested;
        (9) The temperatures in each conditioning environment, and the 
    relative humidity and temperature of the laboratory;
        (10) The peripheral vision clearance;
        (11) A description of any failures to conform to any of the 
    labeling and instruction requirements;
        (12) Performance impact results, stating the location of impact, 
    type of anvil used, velocity prior to impact, and maximum acceleration 
    measured in g's;
        (13) The results of the positional stability test;
        (14) The results of the dynamic strength of retention system test;
        (15) The name and location of the test laboratory;
        (16) The name of the person(s) who performed the test;
        (17) The date of the test; and
        (18) The system check results.
        (c) Format for records. The records required to be maintained by 
    this section may be in any appropriate form or format that clearly 
    provides the required information. Certification test results may be 
    kept on paper, microfiche, computer disk, or other retrievable media. 
    Where records are kept on computer disk or other retrievable media, the 
    records shall be made available to the Commission on paper copies, or 
    via electronic mail in the same format as paper copies, upon request.
    
    Subpart D--Bicycle Helmets Manufactured From March 16, 1995, 
    Through Date That Is 1 Year After the Final Rule Is Issued
    
    
    Sec. 1203.51  Purpose and basis.
    
        The purpose and basis of this rule is to protect bicyclists from 
    head injuries by ensuring that bicycle helmets comply with the 
    requirements of appropriate existing voluntary standards, as provided 
    in 15 U.S.C. 6004(a).
    
    
    Sec. 1203.52  Scope and effective date.
    
        (a) Bicycle helmets manufactured after March 16, 1995, through the 
    date that is 1 year after issuance of the final standard (Subparts A, 
    B, and C) shall comply with the requirements of one of the standards 
    specified in Sec. 1203.53. This requirement shall be considered a 
    consumer product safety standard issued under the Consumer Product 
    Safety Act.
        (b) The term ``bicycle helmet'' is defined at Sec. 1203.4(b).
        (c) These interim mandatory safety standards will not apply to 
    bicycle helmets manufactured after the effective date of the final 
    bicycle helmet standard.
    
    
    Sec. 1203.53  Interim safety standards.
    
        (a) Bicycle helmets must comply with one or more of the following 
    standards, which are incorporated herein by reference:
        (1) American National Standards Institute (ANSI) standard Z90.4-
    1984, Protective Headgear for Bicyclists,
        (2) ASTM standards F 1447-93 or F 1447-94, Standard Specification 
    for Protective Headgear Used in Bicycling, incorporating the relevant 
    provisions of ASTM F 1446-93 or ASTM F 1446-94, Standard Test Methods 
    for Equipment and Procedures Used in Evaluating the Performance 
    Characteristics of Protective Headgear, respectively,
        (3) Canadian Standard Association standard, Cycling Helmets--CAN/
    CSA-D113.2-M89,
        (4) Snell Memorial Foundation (Snell) 1990 Standard for Protective 
    Headgear for Use in Bicycling (designation B-90),
        (5) Snell 1990 Standard for Protective Headgear for Use in 
    Bicycling, including 
    
    [[Page 62680]]
    March 9, 1994 Supplement (designation B-90S),
        (6) Snell 1994 Standard for Protective Headgear for Use in Non-
    Motorized Sports (designation N-94), or
        (7) Snell 1995 standard for Protective Headgear for Use with 
    Bicycles B-95.
        (b) This incorporation by reference was approved by the Director of 
    the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part 
    51. Copies of the standards may be obtained as follows. Copies of the 
    ANSI Z90.4 standard are available from: American National Standards 
    Institute, 11 W. 42nd Street, 13th Floor, New York, NY 10036. Copies of 
    the ASTM standards are available from: ASTM, 1916 Race Street, 
    Philadelphia, PA 19103. Copies of the Canadian Standards Association 
    CAN/CSA-D113.2-M89 standard are available from: CSA, 178 Rexdale 
    Boulevard, Rexdale (Toronto), Ontario, Canada, M9W 1R3. Copies of the 
    Snell standards are available from: Snell Memorial Foundation, Inc., 
    P.O. Box 493, 7 Flowerfield, Suite 28, St. James, New York 11780. 
    Copies may be inspected at the Office of the Secretary, Consumer 
    Product Safety Commission, 4330 East-West Highway, Bethesda, Maryland 
    20814, or at the Office of the Federal Register, 800 N. Capitol Street 
    NW, Room 700, Washington, DC.
    
    Figures to Part 1203
    
    BILLING CODE 6355-01-U
    
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        Dated: November 13, 1995.
    Sadye E. Dunn,
    Secretary, Consumer Product Safety Commission.
    [FR Doc. 95-28761 Filed 12-5-95; 8:45am]
    BILLING CODE 6355-01-C
    
    

Document Information

Published:
12/06/1995
Department:
Consumer Product Safety Commission
Entry Type:
Proposed Rule
Action:
Proposed rule.
Document Number:
95-28761
Dates:
Comments on the proposal should be submitted no later than February 20, 1996.
Pages:
62662-62692 (31 pages)
PDF File:
95-28761.pdf
CFR: (35)
16 CFR 1203.17(a)(3)
16 CFR 19(a)
16 CFR 1203.11(b)
16 CFR 16(b)
16 CFR 1203.4(l)
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