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CPSC Supplementary Material

to Accompany the 1995

Second Draft of their Bicycle Helmet Standard




Summary: This material was gathered by CPSC staff in 1995 to support the second draft of their bicycle helmet standard.






[Federal Register: December 6, 1995 (Volume 60, Number 234)]
[Proposed Rules ]               
[Page 62661-62692]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



[[Page 62661]]

_______________________________________________________________________

Part III





Consumer Product Safety Commission





_______________________________________________________________________



16 CFR Part 1203



Safety Standard for Bicycle Helmets; Proposed Rule


[[Page 62662]]


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 

[[Page 62663]]
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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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 

[[Page 62664]]
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 

[[Page 62665]]
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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    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.







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