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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.
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On June 16, 1994, the Children's Bicycle Helmet Safety Act of 1994
(the ``Act'' or ``the Bicycle Helmet Safety Act'') was enacted. 15
U.S.C. 6001-6006. Section 205 of this Act provides that bicycle helmets
manufactured more than 9 months from that date shall conform to at
least one of the following interim safety standards: (1) The American
National Standards Institute (ANSI) standard designated as Z90.4-1984,
(2) the Snell Memorial Foundation standard designated as B-90, (3) the
ASTM (formerly the American Society for Testing and Materials) standard
designated as F 1447, or (4) any other standard that the Commission
determines is appropriate. 15 U.S.C. 6004 (a)-(b). On March 23, 1995,
the Commission published its determination that five additional
voluntary safety standards for bicycle helmets are appropriate as
interim mandatory standards. 60 FR 15,231. These standards are ASTM F
1447-1994, Snell B-90S, N-94, and B-95, and the Canadian voluntary
standard CAN/CSA-D113.2-M89. In that notice, the Commission also
clarified that the ASTM standard F 1447 referred to in the Act is the
1993 version of that standard. The interim standards are codified at 16
CFR 1203.
Section 205(c) of the Act directed the Consumer Product Safety
Commission to begin a proceeding under the Administrative Procedure
Act, 5 U.S.C. 553, to:
1. Review the requirements of the interim standards described above
and establish a final standard based on such requirements;
2. Include in the final standard a provision to protect against the
risk of helmets coming off the heads of bicycle riders;
3. Include in the final standard provisions that address the risk
of injury to children; and
4. Include additional provisions as appropriate. 15 U.S.C. 6004(c).
Section 205(c) the Act provides that the final standard shall take
effect 1 year from the date it is issued. 15 U.S.C. 6004(c). Section
205(d) of the Act provides that failure to conform to an interim
standard shall be considered a violation of a consumer product safety
standard issued under the Consumer Product Safety Act (``CPSA''), 15
U.S.C. 2051-2084. Section 205(d) also provides that the final standard
shall be considered to be a consumer product safety standard issued
under the CPSA. However, section 205(c) of the Act provides that the
provisions of the CPSA regarding rulemaking procedures, statutory
findings, and judicial review (15 U.S.C. 2056, 2058, 2060, and 2079(d))
shall not apply to this proceeding or to the final standard. 15 U.S.C.
6004(c). When the final standard becomes effective, it will be codified
at 16 CFR 1203 and will replace the interim standards. 15 U.S.C.
6004(d).
B. Originally Proposed Standard
The Commission reviewed the bicycle helmet standards identified in
the Act (ANSI, ASTM, and Snell), as well as international bicycle
helmet standards and draft revisions of the ANSI, ASTM, and Snell
standards that were then under consideration. Based on this review, the
Commission developed a proposed final safety standard for bicycle
helmets. 59 FR 41,719 (August 15, 1994).
The major features of the originally proposed standard were as
follows:
1. Impact attenuation. The originally proposed standard measures
the ability of the helmet to protect the head in a collision by
securing the helmet on a headform and dropping the helmet/headform
assembly from various heights onto a fixed steel anvil. The original
proposal specified a constant mass of 5 kg for the drop assembly (not
including the helmet). However, the Commission requested comment on the
alternative of specifying a different drop mass for each headform size.
Under the proposed standard, the helmet is tested with three types
of anvils (flat, hemispherical, and ``curbstone,'' as shown in Figures
11, 12, and 13 of the revised proposed standard published in this
notice). These anvils represent types of surfaces that may be
encountered in actual riding conditions. Instrumentation within the
headform records the headform's impact in multiples of the acceleration
due to gravity (``g''). Impact tests are performed on different
helmets, each of which has been subjected to one of four environmental
conditions. These environments are: ambient (room temperature), high
temperature (117-127 deg.F), low temperature (3-9 deg.F), and
immersion in water for 4-24 hours.
Impacts are specified on a flat anvil from a height of 2 meters and
on hemispherical and curbstone anvils from a height of 1.2 meters.
Consistent with the requirements of the ANSI, Snell, and ASTM
standards, the peak headform acceleration of any impact shall not
exceed 300 g for an adult helmet, the value originally proposed for
both adult and child helmets. In addition, maximum time limits of 6
milliseconds (``ms'') and 3 ms were originally proposed for the
allowable duration of the impact at the 150-g and 200-g levels,
respectively.
One difference from the ANSI, ASTM, and Snell standards that was
originally proposed for the mandatory standard was the designation for
the area of the helmet that must provide impact protection. The
originally proposed area of impact protection for the CPSC standard was
reached by combining the ANSI and ASTM procedures. The procedure for
defining the area of the helmet subject to impact attenuation testing
is described at Sec. 1203.11.
2. Children's helmets. The originally proposed mandatory standard
specified an increased area of head coverage for small children. A
study by Biokinetics & Associates Ltd. found differences in
anthropometric characteristics between young children's heads and older
children's and adult heads.[6] This study led to an ASTM proposal to
change the position of the basic plane (an anthropometric reference
plane that includes the external ear openings and the bottom edges of
the eye sockets) on the smallest test headform to be more
representative of children ages 4 years and under. Originally,
Sec. 1203.11(b) proposed an extent-of-protection requirement for
helmets intended for children 4 years and under based on the adjusted
basic plane.
\6\Heh. S., Log of ASTM F08.53 Headgear Subcommittee Meeting
held May 21, 1992, Date of Entry--June 17, 1992. Office of the
Secretary, U.S. Consumer Product Safety Commission, Washington, D.C.
20207.
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3. Retention system. The dynamic strength of the retention system
test addresses the strength of the chin strap to ensure against
breakage or excessive elongation of the strap that may contribute to a
helmet coming off the head during an accident.
The test requires that the chin strap remain intact and not
elongate more than 30 mm (1.2 inches) when subjected to a ``shock
load'' of a 4-kg (8.8-lb) weight falling a distance of 0.6 m (2 ft)
onto a steel stop anvil (see Figure 8). This test is performed on one
helmet under ambient conditions and on three other helmets after each
is subjected to one of the different hot, cold, and wet environments.
4. Peripheral vision. Section 1203.14 of the originally proposed
mandatory standard requires that a helmet shall allow a field of vision
of 105 degrees to both the left and right of straight ahead. This
requirement is consistent with the ANSI, ASTM, and Snell standards.
5. Labels and instructions. Section 1203.6 of the proposed
mandatory standard requires certain labels on the helmet, which are
consistent with all
[[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).
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In March 1994, Snell established the N-94 Standard For Protective
Headgear For Use in Non-Motorized Sports. This standard provides
greater head coverage than current bicycle helmet standards, tests for
multiple impacts at a single location on the helmet, and tests to see
if the helmet will roll off on impact. However, the Commission lacks
data that multiple impacts at a single location are a factor in
injuries to persons wearing bicycle helmets or that greater helmet
coverage is needed for bicycle accidents. Furthermore, the use of an
additional anvil in the Snell N-94 test may preclude the use of some
current vent designs used in bicycle helmets. The Commission is aware
of only a few helmets currently on the market that are certified to
this standard.
Activities like roller skating, in-line skating, and skateboarding
are typically conducted on the same types of surfaces as bicycling and
can generate speeds similar to bicycling. In addition, these other
activities do not put the user at a higher height than when using a
bicycle. Thus, fall heights can be expected to be similar. It is
reasonable to assume that the test requirements in the bicycle helmet
regulation would allow the helmet to provide some protection for other
activities--such as in-line skating, roller skating and skateboarding--
until multiple-activity helmets become widely available. However, the
Commission does not have sufficient data on the benefits and costs of
additional features directed at injuries incurred other than bicycling
to make the findings that would be required by either the CPSA or FHSA.
Also, procedures in addition to those required by the Bicycle Helmet
Safety Act would have to be followed. The Commission does not want to
delay establishment of a mandatory bicycle helmet standard in order to
pursue rulemaking for other types of helmets. Accordingly, this
proposed regulation only addresses bicycle helmets.
Comment: General construction provisions. Section 1203.5 of the
originally proposed mandatory standard included several provisions that
addressed general construction characteristics of a bicycle helmet.
These provisions specified that helmets shall be designed to reduce the
acceleration forces imparted to the wearer's head by an impact and to
remain on the wearer's head during impact. It was also specified that
helmets shall be constructed not to be harmful or potentially injurious
to the wearer. For example, the original proposal stated that the
helmet surface shall not have projections that may increase the
likelihood of injury to the rider during an accident. In addition, the
original proposal provided that construction materials should be
resistant to environmental conditions that may be reasonably expected
during helmet use and storage and shall not be harmful to the wearer.
Some commenters on the proposed rule stated that many of the
requirements in Sec. 1203.5 are subjective, since they have no
performance-related criteria. One respondent suggested that these
sections be located in an informative annex rather than in the body of
the standard.
Response: Sections 1203.5(a) and (d) of the original proposal--
titled ``General'' and ``Materials,'' respectively--contained no
objective performance criteria to establish compliance. Section
1203.5(c)--``Retention System''--was redundant since it merely
referenced test requirements elsewhere in the standard. Accordingly,
the Commission is eliminating these paragraphs from the revised
proposal.
The first proposed standard required that external projections must
``readily break away'' and internal projections shall be protected by
``some means of cushioning.'' In response to the comments that this
language was subjective, the Commission is revising the language to
define more objective performance criteria. The revised requirement is
that the helmet be examined after impact testing to determine whether
there are any rigid internal projections that could contact the
wearer's head.
Comment: Children's peak g-value. Some comments recommended that
the peak g-value for children be dropped from 300 g to 250 g or 200 g.
Some commenters suggested that no change be made in the g-value.
Response: Despite the high incidence of head injury among children,
studies addressing mechanisms of injury and recovery are lacking.
Therefore, even though children make up the majority of the population
at risk for head injury, children's helmets sold on the market today
generally are designed to meet the attenuation and absorption criteria
established for the adult helmeted-headform drop tests. The criteria
for testing and evaluating the performance of helmets have been
established primarily on the basis of data derived from injury
tolerance studies conducted on adults. This is a matter of some
concern, since studies indicate that the type of head injury resulting
from blunt trauma may differ significantly between adults and children.
The skull is the brain's primary protection against blunt force
trauma. The properties of the skull change significantly as a child
matures. Cranial capacity reaches adult size by 5 years of age. At 18
months, the brain has attained almost 70% of its adult size and, by 5-8
years, it is 90% of adult size.
Most of the head growth beyond the first 5 years involves hardening
of the skull and thickening of the soft tissue around the brain.
Children appear to be at greater risk of diffuse brain injury because
their skulls have a lower degree of calcification, which provides a
reduced capacity to absorb an impact. This results in a greater
transfer of the kinetic energy from the impact site to the brain
tissue.
The differences in the type of head injuries sustained by children
and adults should have some bearing on helmet design. Currently, no
compensation has been made for the differences between adults and
children in head injury tolerance levels regarding the bending strength
of the skull.
Current United States bicycle helmet voluntary standards recommend
that helmets limit an attenuation impact to below 300 g in order to
reduce the risk of severe injury. However, for the reasons described
above, this may be inadequate to protect children. Published reports
have suggested reducing the g-value for children from 300 g to 150 to
250 g.[8]
\8\Corner JP, Whitney CW, O'Rourke N, and Morgan DE. Motorcycle
and Bicycle Protective Helmets--Requirements. Dept. of Trans. and
Comm., Federal Office of Road Safety, Australia, May 1987. Lane JC.
Helmets for Child Bicyclists, Some Biomedical Considerations.
Federal Dept. of Transport, Office of Road Safety, Australia, CR 47,
1986.
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A helmet may partially compensate for the flexibility of a child's
skull. However, the interior dimensions of the helmet will not
perfectly fit the skull. In an accident, point contact is likely to
occur between the skull and the helmet, which will tend to flex the
child's skull more than an adult's. Accordingly, the Commission
concludes that a differential in the g criteria is needed between
adults' and children's standards. The Commission proposes to lower the
g-value to 250 g. This will provide a substantial extra margin of
safety to account for the increased flexibility of children's skulls,
without making the criterion so stringent that it is either not cost
effective or results in helmets that are so heavy or bulky that their
use would be discouraged.
[[Page 62666]]
Comment: Drop mass. Several commenters favored a variable drop mass
instead of the originally proposed 5 kg drop mass, which would have
been used for testing both adults' and children's helmets. (The
helmet's mass is not included in the drop mass.) Some respondents felt
a reduced drop mass is especially important for testing young
children's helmets. One respondent opposed lowering the drop mass,
stating that there is no benefit in different drop masses for each
headform.
Response: A 1979 study found that in head-first free fall, a
child's body mass and orientation at impact have little influence on
head loading (g-forces) during impact.[9] The study also explains
that head loading in adult falls is influenced by a more complex
relationship between head mass and body mass. This suggests that the
actual head mass of a child is an important factor in determining head
loading during impact.
\9\Mohan D, Bowman B, Snyder RG, and Frost, DR. A Biomechanical
Analysis of Head Impact Injuries to Children. J. Biomechanical Eng.
101, pp. 250-260, U.S., Nov. 1979.
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The helmet liner is designed to absorb the energy of impact by
deformation, and to deform at force levels below that which would cause
head injury. However, children's heads have less mass and their skulls
are more flexible than those of adults. Therefore, a child's head may
not deform the helmet's foam padding during impact if the foam is
designed to protect the heavier adult head. This lack of deformation
may result in greater kinetic energy being transferred to a child's
brain, possibly resulting in a greater likelihood of intracranial
injury. This strongly suggests that children's helmets should be tested
with a lower headform mass than helmets for adults.
The Commission's Directorate for Epidemiology and Health Sciences
concluded that the head mass of children under the age of 5 years
ranges from approximately 2.8 to 3.9 kg. Accordingly, the Commission is
proposing a reduced drop assembly mass of 3.90 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 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 389 +/- 8g
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.