Explanatory Material for the Consumer Product Safety Commission's
Proposed Safety Standard For Bicycle Helmets - Second Draft
Summary: Mostly for historic interest, these are changes made in the CPSC bike helmet standard drafts along the way to adoption of the final standard in 1998.
First, here are two sections from the second CPSC draft with two
of the more interesting changes. We consider both to be most welcome!
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.
(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 S 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 plus or minus
0.1 kg (11.00 plus or minus 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 plus or minus
0.1 kg (8.60 plus or minus 0.22 lb).
(This is a scan from the CPSC staff briefing package for the Commission. We have not
been able to obtain the material electronically. We have checked it, but there could
be minor OCR errors, of course.)
And here is the explanatory material from CPSC for their Proposed Rule
Billing Code 635501
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1203
Proposed Rule: Safety Standard for Bicycle Helmets
AGENCY: Consumer Product Safety Commission.
ACTION: Proposed rule.
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. 59 FR 41,719.
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 [insert date that is 75 days after publication in
the Federal Register].
BHSI Note: We expect that to be sometime in the beginning of February.
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
by [insert date that is 60 days after publication in the Federal
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 EastWest Highway,
Bethesda, Maryland 208144408, telephone (301)5040800. Comments
also may be filed with the Commission by facsimile to t301)5040127,
or by electronic mail via email@example.com. 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.
FOR FURTHER INFORMATION CONTACT: Scott Heh, Project Manager,
Directorate for Engineering Sciences, Consumer Product Safety
Commission, Washington, D.C. 20207; telephone (301)5040494 ext.
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.
This proposal modifies the bicycle helmet standard proposed by
the Commission in the Federal Register of August 15, 1994. 59
The Commission seeks comments from interested members of the public
on any aspect of this standard. Further, 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
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.
[Footnote 1: 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")]. Published data indicate that, in recent years,
almost two-thirds of all bicycle-related deaths involved head injury.
[Footnote 2: 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): 30163018.]
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 bean 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.[Footnote 3: Robert S. Thompson, M.D.; Frederick
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): 13611367.]
The Commission's Bicycle Use Study found that about 18 percent
of bicyclists wear helmets [Footnote 4: 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. 60016006. 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 Z90.41984, (2) the Snell Memorial Foundation
standard designated as B90, (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 14471994, Snell B90S,
N94, and B95, and the Canadian voluntary standard CAN/CSAD113.2M89.
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. 20512084. 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
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 (137127 degrees F),
low temperature (39 degrees F), and immersion in water for 424
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 150g and 200g
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 . [Footnote 5 [Cite to be
obtained.] ] 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.
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 4kg (8.8lb) 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 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
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
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 4kg
(8.8lb) 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 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 CE
of this notice.
C. The Revised Proposed Standard Comments, Responses and Other
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
B95 or Snell N94 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: Multipleactivity 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 inline skating.
Other comments stated that the Commission should not delay promulgation
of the bike helmet standard while multiactivity 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. [Footnote
6 Forum on Head Protection in Recreational Sports, Harborview
Injury Prevention and Research Center (February 18, 1994); Chairman's
Roundtable, MultiActivity Helmets, U.S. Consumer Product Safety
Commission (September 19, 1994).] 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 prescribed by the
CPSA or the Federal Hazardous Substances Act ("FHSA").
In March 1994, Snell established the N94 Standard For Protective
Headgear For Use in NonMotorized 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 N94 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, inline 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 inline 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
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 § 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 per cent
of its adult size and, by 58 years, it is 90 per cent of adult
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. [Footnote 7: 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.]
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' B 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.
Comment: Drop mass. Several commenters favored
a variable drop mass instead of the originally proposed 5 kg drop
mass, which would have bean 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 headfirst free fall,
a child's body mass and orientation at impact have little influence
on head loading (g-forces) during impact. [Footnote 8: Mohan D,
Bowman B, Snyder RG, and Frost, DR. A Biomechanical Analysis of
Head Impact Injuries to Children. J. Biomechanical Eng. 101,
pp. 250260, U.S., Nov. 1979. ]
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.
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 kg ~ 0.1 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
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
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 impactattenuation 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
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 degrees arcs from the center of each
Response: The existing requirement of 105 degrees clearance
from the central point K is an established criterion that provides
sufficient peripheral vision and allows for helmet protective
coverage to the 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
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
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 freefall 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 twinwire and monorail
test rigs through exhaustive comparison testing.
Response: The Commission has no information to indicate
that the suggested freefall 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 freefall 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
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
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
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
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 m2 to 0.10 m2. 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
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 389 plus or minus 8 g 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
from "one fifth the circumference of the helmet" to
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 plus or minus 2 per cent to plus or minus
5 per cent for the tolerance on impact velocity.
Response: Tests by CPSC staff indicated that helmet impact
velocities sometimes fell outside the proposed plus or minus 2
per cent tolerance. However, the impact velocities almost always
were within plus or minus 3 per cent of the specified value. These
tests showed that a plus or minus 3 per cent 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 plus
or minus 3 per cent 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
Response: Language addressing these concerns, including
a definition of "fit," has been added to the revised
Comment: Wetconditioning. A number of commenters
suggested that wetconditioning by totally immersing the helmet
in water is unrealistically severe. These commenters recommended
that the Commission consider a waterspray environment.
Response: Commission testing of both immersed and watersprayed
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 wetconditioning in the proposed
standard. However, additional specifications to standardize the
wet environment are included.
Comment: Anvil test schedule. In the originally
proposed standard, helmets l 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 l 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 B90(S), N94, and B95 helmet standards.
(Under the revised proposal, the fifth helmet is tested only for
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. staticload positional stabi1ity 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: Selfrelease 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 l990, 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."
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. [Footnote 9
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
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: Agespecific 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 § 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 N94 and B95 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 provide
means to reduce the risks of serious neck injury to bicyclists
and participants in other recreational activities. The Commission's
staff will continue to monitor progress in this area. Although
the Commission always encourages research and development of safetyrelated
devices, the Commission lacks data on the potential for developing
a device that would prevent neck injuries and be acceptable to
consumers. Accordingly, it is premature for the Commission to
actively encourage the development and marketing of such devices.
In addition, such devices are beyond the scope of this proceeding.
Other changes to the standard:
l. 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 § 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 i 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 i 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 bean 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.
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 B90
standard. Compared to the test lines in other U.S. voluntary bike
helmet standards to which bike helmets are currently certified,
the Snell B90 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 (§ 1203.4(f)) to be a specified distance from the
reference plane (defined at § 1203.4(1) and Figure 3), rather
than from the basic plane (defined at § 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 § 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
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 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
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
The firms responsible for certification know their products and
manufacturing processes. These firms are in the best 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
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 non-complying
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
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
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 bean no change in the physical
dimensions of a helmet, there would be no need to retest the helmet's
No change to the proposal is required to accommodate this commenter's
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
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 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
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
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 § 16(b) of the CPSA, 15 U.S.C. 2065(b).
Comment: Location of test records. The origina1
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 48hour time period, the records will be considered kept in
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 §
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 onetime
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
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 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
1year 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 and to keep records of
such testing. They 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. 350120,
Pub. L. No. 10413, 109 Stat. 163 (1995). Proposed revisions to
the regulations under the Paperwork Reduction Act, 5 CFR Part
1320, were published by the Office of Management and Budget ("OMB")
on June 8, 1995. 60 FR 30,438.
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. Persons wishing to comment
to OMB on these proposed collection of information requirements
should submit their comments by [insert date that is 60 days from
publication of this notice in the Federal Register].
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
PART 1700Safety Standard for Bicycle Helmets
1. The authority citation for Part 1203 shall continue to read
AUTHORITY: Secs. 201207, Pub. L. 103267, 108 Stat. 726729, 15
2. Part 1203 is revised to read as follows:
BHSI Note: This is the end of the CPSC material we have