Proposed Rule: Safety Standard for Bicycle Helmets

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

[email protected]. 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 kg0.1 kg for

testing helmets for children under 5. The lower mass will better

represent the head mass of children under 5 years of age than the 5 kg

mass specified for testing helmets for older children and adults.

Testing helmets for children under 5 years with a more appropriate

mass should lead to helmets that are better designed to accommodate

maturational differences of a young child's head. An even lower mass is

not feasible with current test rigs, because a drop assembly mass of

less than 3.90 kg would shift the center of gravity on current test

equipment enough to potentially influence test results.

Comment: Extent of protection. Current U.S. voluntary bicycle

helmet standards, and the originally proposed CPSC standard, specify an

extent-of-protection boundary and an impact test line. The extent-of-

protection boundary defines the area of the head that must be covered

by the helmet. The impact line designates the lowest point on the

helmet where the center of the anvil may be aligned for testing. A

clearance is specified between the extent-of-protection boundary and

the impact line to allow for the imprint of the test anvil.

A number of comments on the proposed standard concerned the extent-

of-protection (or extent of coverage) requirements. One commenter

stated that the extent-of-protection requirement was subjective since

no test is applied in these areas. Some commenters believed the

proposed extent-of-protection requirement was design-restrictive, since

some helmets have features like rear vents that may rise above the

extent of coverage line but nevertheless will provide protection if

impacted on the test line.

Response: The Commission believes that a performance test using a

single test line and no extent-of-protection requirement is adequate

for testing the impact-attenuation capabilities of a helmet. Not

requiring specific helmet coverage allows manufacturers the flexibility

to include desirable features such as a central rear vent, provided the

features do not hinder the helmet's ability to meet the impact

requirements if tested anywhere on or above the test line. Accordingly,

the Commission has deleted the extent-of-protection line from the

revised proposed standard.

Comment: Extended coverage for young children's helmets. A number

of commenters favored an extended area of coverage for young children's

helmets. However, one commenter suggested that the coverage lines

defined in the first CPSC-proposed standard were not practical, since

portions of the test line extended lower than the edge of an impact

headform.

Response: As noted above, young children's skulls lack the

calcification of older children's and adult skulls. This is especially

true of children under 5 years old, where the curve of head growth and

skull development is steepest. The temporal region (area above and

around the ear) is much thinner than other parts of the skull. As a

result, a much smaller force at the temporal region can cause a serious

injury than at other regions of the skull. Accordingly, the Commission

concludes that helmets for children under 5 years should have a greater

area of protection than those for older children and adults.

A recent proposal for infant helmet test lines by the ASTM Headgear

Subcommittee Infant/Toddler Working Group specifies a ``two-step'' test

line that is measured directly from the reference plane of the ISO A

and ISO E headforms. The Commission considers the proposed ASTM test

line appropriate for testing helmets for children under 5 years. The

revised test line (Figure 5) provides an increased area of protection,

including the temporal area.

Many young children's helmets on the market already provide an area

of protection comparable to the revised CPSC proposal, though it is not

required by any current U.S. bike helmet standard. The revised CPSC

test line is easier to define and mark on a helmet than the first

proposed CPSC line, which was referenced from an adjusted basic plane

inclined 15 degrees from horizontal. This new test line does not extend

lower than the edge of the headform.

Comment: Determining which helmets are for young children. A

commenter asked for clarification of how to determine whether helmets

are ``intended'' for children 4 years and under. The concern is that

small helmets are often sold to adults with small heads.

Response: Typically, helmets for children are advertised and

promoted with children's themes. The Commission will consider relevant

factors, such as the design and marketing of a helmet, to determine

whether it is intended for young children.

However, it is also important that consumers not mistake adult and

older children's helmets that are the same size as helmets for children

under 5 years of age as complying with the extra coverage and other

special provisions required for helmets intended for children under 5.

Therefore, the proposal provides that helmets specifically designed for

children under 5 years of age be labeled to read: ``Complies with CPSC

Safety Standard for Bicycle Helmets for Children Under 5 years.''

Comment: Peripheral vision. One commenter recommended revising the

peripheral vision requirement to specify clearances of two separate

105 deg. arcs from the center of each eye.

Response: The existing requirement of 105 deg. clearance from the

central point K is an established criterion that provides sufficient

peripheral vision and allows for helmet protective coverage to the

[[Page 62667]]

temporal area of the head. The proposed criterion is consistent with

ANSI, ASTM, and Snell bicycle helmet standards, and with the FMVSS 218

motorcycle helmet standard. Therefore, the Commission makes no change

to the proposed rule in response to this comment.

Comment: Vertical vision. One commenter suggested that the

Commission adopt requirements for a vertical field of vision.

Response: The Commission has no information to indicate that

bicycle helmets are posing a risk of injury due to inadequate upward or

downward visual clearance. Accordingly, the Commission is not proposing

a vertical field of vision requirement.

Comment: Dwell time. Several commenters disagreed with the dwell

time specification in the first proposed CPSC standard.

Response: The Commission agrees with these comments, and the impact

attenuation requirements are revised to specify only peak g as the

evaluation criteria. This change was made because of a lack of

scientific evidence to support application of dwell time as a bike

helmet evaluation criterion.

Comment: Point loading requirements. Two commenters recommended

that the Commission explore requirements to limit localized loads on

the head that could be caused by strategically located high-density

foam in helmet liners.

Response: The Commission has no information to indicate that some

helmet designs may pose a risk of injury due to localized loading.

Therefore, the Commission is not adding point loading requirements to

the proposed rule at this time.

Comment: Daytime and nighttime conspicuity. Some comments related

to possible requirements for helmets to improve a bicyclist's

conspicuity in both daytime and nighttime conditions.

Response: Available data do not suggest that requirements to

increase the visibility of bicyclists to others would significantly

reduce daytime incidents. Data do show an increased risk of injury

while bicycling during non-daylight hours.

Commission staff observed informal demonstrations which suggested

that reflective material on bike helmets could enhance the conspicuity

of a nighttime rider. However, at this time, the Commission lacks

information on what requirements might be effective to achieve this

goal.

The Commission intends to study this issue further in conjunction

with planned work on evaluating the bicycle reflector requirements of

CPSC's mandatory requirements for bicycles. 16 CFR part 1512. After

that work is completed, the Commission will decide whether to propose

reflectivity requirements for bicycle helmets under the authority of

the Children's Bicycle Helmet Safety Act of 1994. The Commission does

not intend to delay issuance of the standard proposed in this notice to

coincide with any reflectivity requirements that may be issued later.

Comment: Type of test rig. The originally proposed CPSC standard

and the current interim mandatory standards allow the use of either a

wire- or rail-guided impact test rig. A commenter recommended that the

Commission adopt a free-fall test rig that has no rigid connection

between the headform and the guide system. The Commission also received

a proposal from one respondent to evaluate differences between twin-

wire and monorail test rigs through exhaustive comparison testing.

Response: The Commission has no information to indicate that the

suggested free-fall rig provides a more reliable test system or that it

represents the dynamics of a human head impacting a surface better than

other types of impact test equipment. Accordingly, the Commission is

not proposing a free-fall test rig.

To avoid the possibility that different results would be obtained

with the two types of test rigs, the Commission is specifying only the

monorail test rig in the revised mandatory standard. The suggested

tests would be helpful only if both test rigs were permitted.

For helmet certification testing, the regulation does not require

that the manufacturer follow specifically the procedures of the CPSC

standard. Thus, a manufacturer may chose to certify helmets by testing

with a wire-guided test rig, provided the manufacturer assures that the

helmets will meet the requirements of the CPSC standard when tested on

the standard's monorail test rig.

Comment: Dynamic strength of retention system test--spinning

rollers. A comment suggested that the ``jaw rods'' in the strength of

retention system test rig should be rotatable.

Response: The requested feature is consistent with provisions in

both the ANSI and Canadian standards and should help ensure that the

maximum loading is transmitted to the retention system attachment

points. Accordingly, the Commission has adopted this suggestion, and

the revised proposal states that the ``stirrups'' that represent the

bone structure of the jaw shall be freely spinning cylindrical rollers.

Comment: Dimensions of impact base. Three commenters recommended

revising the standard to allow a smaller impact base. The commenters

claimed that the dimensions specified in the proposed standard are not

consistent with many existing test rigs.

Response: The Commission concludes that there is no known reason to

exclude bases with smaller surface dimensions. Therefore, the

Commission proposes to reduce the minimum surface area specification

from 0.30 m\2\ to 0.10 m\2\. This is consistent with impact base

specifications in Snell helmet standards. The minimum mass of the

impact base will still be the originally proposed 135 kg.

Comment: Instrument system check procedure. One commenter claimed

that the instrument system check procedure specified in the first

proposed rule only tests repeatability and not the accuracy of

calibration. The commenter recommended that the procedure allow using a

test headform, instead of the spherical impactor, for the instrument

system check impacts. The commenter also suggested that the instrument

system check be performed at least once a week.

Response: The commenter is correct that this instrument system

check procedure primarily indicates that the test is producing

repeatable results. The Commission's staff, using the procedures

proposed in the originally proposed CPSC standard, obtained daily test

results on an average of 12 drops of a spherical impactor on a modular

elastomer programmer (``MEP'') pad for 3 months. These tests yielded

peak accelerations that met the originally proposed 3898g

criteria for the specified velocity range. The specific g-level that

will be achieved depends on the MEP pad in use.

The Commission agrees that the instrument system check procedure

should have greater flexibility to allow other laboratories to conduct

testing based on their internal procedures. To help assure that

consistent, reproducible data are obtained, the Commission proposes to

continue the use of an impactor with a spherical impact surface, rather

than impact headforms. The Commission also believes that the system

check interval should not be longer than the beginning and end of each

test day. The revised procedure, however, is not intended to prevent

each laboratory from exercising sound engineering practice in

establishing their specific methodology.

Comment: Distance between impacts. A commenter recommends revising

the minimum distance between impact sites

[[Page 62668]]

from ``one fifth the circumference of the helmet'' to 120 mm.

Response: The Commission believes that 120 mm allows sufficient

distance to minimize the effects of impact site proximity and provides

a more straightforward measurement than the original one-fifth

circumference criteria. Accordingly, the Commission proposes to adopt

this recommendation.

Comment: Impact velocity tolerance. One commenter suggested a

change from 2% to 5% for the tolerance on

impact velocity.

Response: Tests by CPSC staff indicated that helmet impact

velocities sometimes fell outside the proposed 2%

tolerance. However, the impact velocities almost always were within

3% of the specified value. These tests showed that a

3% velocity tolerance is reasonable to maintain a test

procedure that will reliably indicate the equipment is functioning

properly. Accordingly, the velocity tolerance for helmet testing has

been changed to 3% in the revised proposal.

Comment: Number of helmets required for testing. Comments were

submitted requesting clarification of the number of helmet samples

needed if attachments are provided with the helmet and if the helmet

fits two headform sizes.

Response: An additional set of five helmets is needed for each

additional attachment (e.g., visors or shields), or combinations

thereof, sold for use with the helmet. Two additional samples per set

are needed if the helmet fits two headform sizes.

Comment: Fit and testing. A comment stated that the standard needed

to define ``fit'' as it relates to the process of selecting a test

headform. Another comment provided a definition of ``fit'' and

suggested that the language for selecting a test headform should more

clearly explain how a sample set of helmets is divided when a helmet

fits two different headform sizes.

Response: Language addressing these concerns, including a

definition of ``fit,'' has been added to the revised proposed rule.

Comment: Wet-conditioning. A number of commenters suggested that

wet-conditioning by totally immersing the helmet in water is

unrealistically severe. These commenters recommended that the

Commission consider a water-spray environment.

Response: Commission testing of both immersed and water-sprayed

helmets under various time durations showed no consistent trend in

resulting peak acceleration levels. The immersion environment has the

advantages of being easier to define and of subjecting the helmet to a

uniform conditioning exposure. Since testing showed that these

commenters' concerns are unfounded, the Commission is retaining the

immersion method of wet-conditioning in the proposed standard. However,

additional specifications to standardize the wet environment are

included.

Comment: Anvil test schedule. In the originally proposed standard,

helmets 1 through 4 would have been tested with the flat and

hemispherical anvils and the fifth helmet would be tested with the

curbstone anvil. Two commenters suggested that there is no reason for a

curbstone anvil impact to be treated differently from the flat and

hemispherical anvil impacts.

Response: Each anvil has a unique ``imprint'' that could stress

helmet designs differently. Therefore, the proposed standard has been

revised so that each of test helmets 1 through 4 must meet the

standard's impact criteria on four impacts, once with each of the three

anvils and once with the anvil likely to result in the highest g-value.

In the absence of an indication why another anvil would be more

stringent, this fourth impact should be made with the anvil that

produced the highest g-value in the previous three impacts. This is

consistent with the test schedules of the Snell B-90(S), N-94, and B-95

helmet standards. (Under the revised proposal, the fifth helmet is

tested only for positional stability.)

Comment: Helmet straps. A commenter recommended that the test

procedure require that all slack be removed from the helmet straps when

fastening the helmet to the test headform.

Response: The Commission agrees with this comment and has revised

the proposal accordingly.

Comment: Lateral positional stability test. A commenter recommended

the addition of a positional stability test in the lateral direction.

Response: The shape of the head is such that a properly fitted

helmet is more likely to come off to the front or rear than to the

side. Accordingly, the suggested lateral positioning test is

unnecessary and not proposed.

Comment: Dynamic v. static-load positional stability test. One

commenter suggested that the CPSC consider the static load positional

stability test specified in the Canadian Standards Association ('CSA')

bicycle helmet standard.

Response: The Commission believes that a dynamic test provides a

more rigorous and realistic test of the restraint system, and has not

adopted this suggested change.

Comment: Retention system test schedule. Some commenters asked that

the CPSC consider a change to the test schedule so that at least one

impact attenuation drop per sample would be performed prior to testing

the retention system.

Response: CPSC staff testing did not show evidence to warrant a

change in the sequence of retention system strength tests and impact

tests. Accordingly, the Commission did not make this suggested change.

Comment: Use of a Rubber Pad on the Stop Anvil. One commenter

recommended using a rubber pad between the steel drop mass and the stop

anvil.

Response: The current ASTM and ANSI bicycle helmet standards do not

require a rubber pad on the stop anvil. Based on comparison testing

with and without a rubber pad, the Commission believes a rubber pad may

produce a somewhat less stringent test. In the absence of any

compelling reason to allow a rubber pad, therefore, the Commission has

not changed the original proposal in this regard.

Comment: Self-release buckle. One commenter suggested that

consideration be given to requirements for a self-release buckle that

could be used to prevent strangulation if the helmet becomes caught.

The commenter stated that there are now efforts in Europe to develop a

test method that would ensure that buckles release or break away when

subjected to a load equivalent to the weight of a child.

Response: The Commission has received reports of eight or nine

deaths of children in Sweden and Norway that occurred when helmets

became caught in trees or playground equipment, causing the child to

become suspended by the chin strap. The Commission also has received

reports of four nonfatal incidents in the United States since 1990,

involving children of ages from 5 through 7 years, that occurred in the

same fashion.

However, the Commission is not proposing requirements for a self-

release buckle at this time. Considering the frequency and potential

severity of head injuries in bicycle accidents, it is important to

ensure that the helmet retention strength requirements are not

compromised.

Comment: Use labeling. A number of comments concerned what

information should be on a bike helmet label to inform consumers of the

helmet's intended use. Some commenters favored the ``Not For Motor

Vehicle Use'' label that was first proposed in the CPSC standard.

Others felt the helmet should be labeled ``For Bicycle Use Only.''

[[Page 62669]]

Response: Currently, the ANSI and Snell voluntary standards require

the label ``For Bicycle Use Only.'' ASTM requires the label ``Not for

Motor Vehicle Use.'' The ASTM label was originally proposed because

helmets are currently not made specifically for many non-bicycling

activities, and people should not be discouraged from using a helmet

for such activities by a label that states it is for bicycle use

only.10

\10\In fact, despite the ``For bicycle use only'' label, the

U.S. Amateur Confederation of Roller Skating adopted the ANSI and

Snell helmet standards years ago for use in competitive roller

skating.

---------------------------------------------------------------------------

Other commenters, however, disagreed. One indicated that labeling

``Not for Motor Vehicle Use'' would stifle the development of separate

helmet standards for other sports by voluntary organizations. The

commenter believed that the ``Not for Motor Vehicle Use'' label

suggests that a bicycle helmet is as effective for any non-motorized

use as a helmet designed specifically for that activity.

The Commission has no evidence to support the contention that the

ASTM label would inhibit the development of voluntary standards for

non-motorized activities, and no evidence that a bicycle helmet is

inadequate for some of these activities. For this reason, the

Commission continues to propose the ASTM label, ``Not for Motor Vehicle

Use.''

Comment: Label language and format. Some commenters suggested that

the labels have specific language and format (e.g., the ANSI Warning

Format).

Response: The Commission concludes that requiring specific language

or format is inappropriate for bicycle helmet labels, because the

variety of helmet styles and limited space on the interior of some

helmets requires more flexibility in labeling.

Comment: Fit information on box. One commenter recommended that

information on how to properly fit a helmet be required on the outside

of the box.

Response: Children frequently report uncomfortable fit as a reason

for not wearing a helmet all the time. It is reasonable to expect that

improper fit was sometimes involved in complaints that helmets are

uncomfortable. A label on the box could inform parents, before they buy

the helmet, that they need to properly fit it to the child's head.

However, the Commission is not aware of any information which indicates

that such a label would be any more effective in assuring proper fit in

use than the originally proposed instructions, which need not be on the

box. Accordingly, the Commission did not adopt this requested change.

Comment: Age-specific fit instructions. A commenter suggested that

instructions on fitting a helmet be age-specific, so that a young child

can read them.

Response: The Commission believes that age-specific instructions

are unnecessary. The Commission lacks data showing that young children

would act on age-specific instructions without urging from their

parents. The originally proposed rule requires that the instruction

sheet have graphics showing proper fit and position of the helmet.

Children who can read may well be able to understand pictures showing

proper fit. If not, the involvement of parents will likely be needed to

convey the information on how to fit the helmet. Parents reading along

with the child and discussing the pictures will likely deliver the

message of proper fit.

Comment: Life of helmets. One commenter was concerned that the

requirement of Sec. 1203.6(a) that labels be legible for the life of

the helmet was indefinite, because the life of a helmet is not known.

Response: Snell N-94 and B-95 helmet standards recommend that

helmets be replaced after 5 years, or less if the manufacturer so

recommends. The Commission concludes that the manufacturer or importer

can determine the life of a particular helmet and assure that the

labels will remain legible for that time. However, to make this

requirement more definite, the Commission has amended the proposal to

state that the labels shall remain legible for the intended design life

of the helmet.

Comment: Helmet label--post-impact instructions. Some commenters

requested that more direct information be provided about what to do

with a helmet that has received an impact. One respondent stated that

the current wording--``after receiving an impact, the helmet should be

returned to manufacturer or be destroyed and replaced''--is ambiguous.

Response: Damage to a helmet from an impact is not always visible

to the user. To describe on a label the circumstances in which helmets

can be used again, can be fixed, or should be destroyed, if feasible at

all, would make the label excessively wordy and likely to be skimmed or

ignored. Therefore, the Commission concludes that the most specific and

appropriate label would state that the helmet be returned to the

manufacturer or destroyed after impact because any damage may not be

visible to the user.

Comment: Neck injury protection. One commenter requested that the

Commission include in this Federal Register notice a statement

encouraging helmet manufacturers to ``undertake the development and

marketing of helmets that protect wearers from paralyzing neck injuries

as a result of bicycle riding.'' The commenter referred to a report

that indicates that bike helmets reduce the risk of head injury, but do

not seem to have any effect in reducing the risk of serious neck

injury.

Response: The Commission is aware of some efforts to reduce the

risks of serious neck injury to bicyclists and participants in other

recreational activities. The Commission always encourages research and

development of safety-related devices. The Commission's staff will

continue to monitor progress in this area. However, such devices are

beyond the scope of this proceeding.

Other changes to the standard:

1. Impact-attenuation test--support assembly mass. The

specification that the mass of the support assembly be no greater than

25 percent of the mass of the total drop assembly has been deleted. The

boundary on the location for the center of gravity at

Sec. 1203.17(a)(3) will adequately limit the mass variance between the

support assembly and the headform assembly.

2. Dynamic strength of retention system test--mass of the test rig.

The ASTM F1446 standard specifies a support assembly mass in the range

of 6 kg to 12 kg (including the drop mass). CPSC considered this range

too wide when developing the first CPSC proposed standard and specified

a mass of 6 kg with a tight tolerance of 0.5 kg.

Subsequent consideration of this issue by the ASTM Headgear

Subcommittee concluded that the assembly mass, excluding the drop

weight, should be specified at 7 kg (11 kg including the drop weight)

with a narrow tolerance. It was agreed that this rig applies a rigorous

test of retention system strength and provides a system better suited

for adapting an electronic displacement transducer to provide an

accurate means for measuring elongation. Accordingly, the mass of the

test rig has been revised to 11 kg 0.5 kg.

3. Dynamic strength of retention system test--deletion of preload

ballast procedure. The procedure to place a preload ballast on top of

the helmet has been deleted, since the more massive test rig in the

revised proposal applies a sufficient preload to the helmet retention

system to set the helmet fit padding against the test headform.

[[Page 62670]]

4. Children's helmets--age range. The age break for special

provisions for children's helmets was originally proposed for

``children 4 years of age and under.'' The Commission has revised this

language to ``children under 5 years of age.'' This language clarifies

the intent to include children until they reach their fifth birthday.

5. Older children and adults test line. The Commission is proposing

a revised test line for adults' and older children's helmets, as shown

in Figure 4. The portion of the test line that extends from the front

of the headform and through its center portion is essentially the test

line specified in the Snell B-90 standard. Compared to the test lines

in other U.S. voluntary bike helmet standards to which bike helmets are

currently certified, the Snell B-90 test line provides the greatest

area of impact protection in the front and central portions of the

head.

The rear step in the revised CPSC test line is derived by using a

20 mm clearance from the extent-of-protection boundary specified in the

August 15, 1994, CPSC-proposed bike helmet standard. The revised test

region provides an acceptable area of head protection while allowing

for certain design flexibility.

6. Definition of Helmet Positioning Index (``HPI''). In the

originally proposed standard, the HPI is defined as a distance that

locates where the brow of the helmet should be positioned on the

headform. In the revised proposal, the HPI is defined (Sec. 1203.4(f))

to be a specified distance from the reference plane (defined at

Sec. 1203.4(l) and Figure 3), rather than from the basic plane (defined

at Sec. 1203.4(a) and Figures 1 and 2). This change is made because

impact headforms are cut away (above the basic plane) at the front brow

area, making it difficult to measure for the HPI from the basic plane.

D. Certification Testing and Labeling

General. Section 14(a) of the CPSA, 15 U.S.C. 2063(a), requires

that every manufacturer (including importers) and private labeler of a

product that is subject to a consumer product safety standard issue a

certificate that the product conforms to the applicable standard, and

to base that certificate either on a test of each product or on a

``reasonable testing program.'' Subpart B of the proposed Safety

Standard for Bicycle Helmets contains these certification requirements.

The originally proposed certification rule. The proposed

certification rule would require manufacturers of bicycle helmets that

are manufactured 1 year after the issue date of the final standard to

affix permanent labels to the helmets. These labels would be the

``certificates of compliance,'' as that term is used in Sec. 14(a) of

the CPSA. In the rule as originally proposed, all helmets would have

had a label stating ``Complies with CPSC Safety Standard for Bicycle

Helmets (16 CFR 1203)''. As explained below, the Commission is

proposing somewhat different language for this label.

In some instances, the label on the bicycle helmet may not be

immediately visible to the ultimate purchaser of the helmet prior to

purchase because of packaging or other marketing practices. In those

cases, it is proposed to advise consumers that the helmet meets the

CPSC standard by a second label that would be on the helmet's container

or, if the container is not visible, on the promotional material used

in connection with the sale of the bicycle helmet.

The proposed certification label also contains the name and address

of the manufacturer or importer, and identifies the production lot and

the month and year the product was manufactured. Some of the required

information may be in code.

The proposed certification rule requires manufacturers and

importers to conduct a reasonable testing program to demonstrate that

their bicycle helmets comply with the requirements of the standard.

This reasonable testing program may be defined by the manufacturers,

but must include either the tests prescribed in the standard or any

other reasonable test procedures that assure compliance with the

standard.

The originally proposed certification rule provides that the

required testing program will test bicycle helmets sampled from each

production lot in such a manner that there is a reasonable assurance

that, if the bicycle helmets selected for testing meet the standard,

all bicycle helmets in the lot will meet the standard.

The rule as originally proposed provided that bicycle helmet

importers may rely in good faith on the foreign manufacturer's

certificate of compliance, provided that a reasonable testing program

has been performed by or for the foreign manufacturer; the importer is

a U.S. resident or has a resident agent in the U.S.; and the required

test records are kept in the U.S. As explained in section E below, the

Commission proposes an exception to the requirement that test records

must be kept in the U.S.

Comments, responses, and other changes to the certification testing

and labeling requirements.

Comment: Production lot. One commenter stated that the rule should

use ``frequency of production'' rather than the originally proposed

``manufacturing lot'' method to define a lot. The commenter explained

that a manufacturing lot may encompass well over a million helmets if

there are no changes in the design and production of a helmet. The

commenter further explained that using frequency of production as the

basis of the required reasonable testing program would require a firm

to test after a specified number of helmets are produced. The commenter

believes this would catch any defects more readily.

Another commenter stated that the production lot should be based on

a monthly or yearly period, as a production lot could include helmets

made well after the qualification testing.

Another commenter stated that the proposed definition of a

production lot is unmanageable and may be expensive if a large number

of helmets is produced and if there are any variations in the materials

or processes in the production of the helmets. The commenter recommends

that the definition of production lot be changed to either

``sequentially labeled helmets bonded and tested separately, or a

continuous production of like models produced in accordance with a

quality system ensuring traceability for all component parts.'' Comment

CC94-2-25.

In addition, a commenter stated that CPSC should allow

manufacturers flexibility to establish their own recognized quality

assurance program, such as Mil Std 105D, ISO 9000, or ASQC.

Response: The proposed rule defines a ``production lot'' as ``a

quantity of bicycle helmets from which certain bicycle helmets are

selected for testing before certifying the lot.'' In the proposed

regulation, the helmets in a lot must be essentially identical in

design, construction, and materials. This definition of a production

lot does not require the lot to be a specified number of helmets or a

set time interval of helmet production, such as weekly or monthly.

However, the definition in the proposed regulation does not prohibit

certification based on testing after a specified number of helmets or

period of time, provided that changes in the design, construction, or

materials of the helmet are not made in that production lot. Firms must

define their production lots in such a fashion that samples collected

for testing represent all the bicycle helmets in a particular lot.

The firms responsible for certification know their products and

manufacturing processes. These firms are in the best

[[Page 62671]]

position to define their production lot and set up a reasonable testing

program in order to assure that their helmets meet the standard.

Furthermore, testing on only a number or time basis could allow changes

in the helmets' specifications during a production lot that might cause

failing results to go undetected until the specified interval occurs.

Accordingly, the Commission is not proposing to require testing after a

specified number of helmets or time period of production.

A firm is not restricted in any way from establishing its own

quality control program, including programs based on Mil Std. 105D, ISO

9000, or ASQC. Therefore, no change in the proposal is required in this

regard.

The Commission believes that the certifying firms can determine,

based on their production lot and methods of manufacture, how best to

sample their lot in order to insure that the helmets meet the standard.

Comment: Sampling. A commenter stated that the testing program

should provide for sampling over the entire production lot in order to

discover the production of noncomplying helmets.

Response: Under the proposed rule, there is no requirement that

sampling be conducted over the entire production lot. The rule states

that the manufacturers and importers may set up their own testing

program, provided the program is reasonable. The testing program is to

insure that the helmets selected for testing represent all the helmets

in the production lot. For the guidance of certifying firms, however,

the Commission notes that a reasonable testing program would include

both prototype and production testing, to provide reasonable assurance

that all of the bicycle helmets in the production lot being tested

comply with the requirements of the standard.

Comment: Certification label. A commenter inquired whether the

content of the certification label could be divided among more than one

label.

Response: The originally proposed regulation did not address

whether the placement should be on one label. However, the restricted

space inside helmets requires that there be flexibility for the format

of the certification labeling.

The Commission's Division of Human Factors believes that the name

and address of the manufacturer, private labeler, or importer, where

required and not in code, should be on one label. This is so the

consumer can associate the address with the name if it is necessary to

contact the manufacturer, private labeler, or importer for repair or

replacement of the helmet. Also, if it is too difficult to find the

information, consumers are less likely to follow through with repair or

replacement of helmets. Accordingly, the Commission is revising the

proposal to require that the name and address of firms required to be

identified uncoded on the label must be on the same label.

However, the Commission now proposes to allow separate labels for

the other required information, including the statement of compliance

with the CPSC standard, the production lot, and the date of

manufacture.

Comment: Third-party testing. A commenter suggested that

certification testing should be conducted by a third party and include

off-the-shelf random testing.

Response: Under the proposed rule, testing may be done by the

manufacturer or importer or by a third party. Regardless of who

performs the test, certifying firms are responsible for insuring

compliance with all requirements of the standard. No data are available

showing that third-party certification would improve compliance with

the standard. Accordingly, there is no reason to change the proposal in

that regard.

Comment: Verification by CPSC. A commenter suggested that the

quality control testing program, testing equipment, and calibration of

the testing equipment should be verified by CPSC.

Response: It would be an inefficient use of Commission resources to

conduct either quality control verification or calibration of industry

equipment, and the need to do this has not been demonstrated.

Accordingly, the proposal is unchanged in this regard.

Comment: Production testing of features unlikely to change. A

commenter stated that, once a model is certified, testing of helmets

for peripheral vision, labeling, and instructions are unnecessary when

performing routine compliance testing.

Response: The proposal allows each firm to establish its own

testing program, provided the testing program is reasonable. No

specific tests are required. When there have not been any changes in

the design of the helmet, the firm may establish simple visual

examination of some attributes of helmets. For example, if the

manufacturer is assured that there has been no change in the physical

dimensions of a helmet, there would be no need to retest the helmet's

peripheral vision.

No change to the proposal is required to accommodate this

commenter's concern.

Comment: Certification label content--coding of foreign

manufacturer. A commenter complained that the true name of the foreign

manufacturer could be coded and not disclosed.

Response: The intent of the certification label is to identify a

party that the consumer or the CPSC can contact concerning the safety

of a helmet. In addition, consumers need to be able to contact someone

in the U.S. for repair or replacement information. Since foreign

manufacturers are not subject to this regulation, there is no need for

consumers to know the identity of the foreign manufacturer.

Accordingly, the importer may code the foreign manufacturer's name.

Similarly, a private labeler may code the U.S. manufacturer or both the

importer and foreign manufacturer.

The identification of the coded information must be available upon

request from the importer or private labeler whose name is required to

appear on the certification label. This adequately protects the

interests the consumer and the CPSC have in this information. In

addition, consumers could be confused if two firms were identified on

the label. Accordingly, no change to the proposal is made in this

regard.

Comment: Certification label content--age of helmet. A commenter

stated that permitting the coding of the product lot number and the

date of manufacture denies consumers important information on the age

of their helmets, as manufacturers commonly recommend replacing the

helmet after 5 years. The commenter contends also that it would be

easier for consumers to recognize recalls of helmets identified by

dates on the helmets rather than by other codes.

Response: Under the proposed rule, the manufacturer, importer, or

private labeler may code the production lot and the date of production.

These codes on the helmets should not place an undue burden on the

consumer in determining the date of manufacture, as this information

can be obtained if necessary.

Manufacturers recommend that helmets be replaced after 5 years of

use. The manufacture date or code would not identify the ``use'' age of

the helmet, which relates more to the date of purchase of the helmet.

During recalls, the affected firms will identify the model of the

helmet, any codes, where it was sold, and the dates of distribution. A

consumer can readily ascertain if his/her helmet is being recalled by

examining the model number and the date of manufacture, which may be

coded. Having the manufacturing date coded would not

[[Page 62672]]

interfere with identifying a recalled helmet. Accordingly, no change in

the proposal is needed in this regard.

Comment: Certification label content--date of manufacture, serial

number, and test date. One firm wants to provide the date of

manufacture, serial number, and test date on the helmet, rather than a

production lot.

Response: The proposed regulation requires the production lot and

the month and year of manufacture to be identifiable from the label,

but does not require or prohibit the serial number or test date. Both

the production lot and the time of manufacture may be in code. The test

date would not add any information for the consumer. The serial number,

however, may serve as a code to identify the production lot and, if so,

may be used in its place.

Accordingly, the proposed rule has been revised to state that a

serial number may be used in place of a production lot identification

if it can serve as a code to identify the production lot.

Comment: Certification label content--telephone number. A commenter

contends that the telephone number of the responsible firm should be on

the certification label.

Response: A telephone number is not required. This might place a

burden on small firms with insufficient staff to handle a large number

of calls. The consumer can contact the responsible firm in writing if

the need arises.

Other change: Compliance labels. Section 14(a) of the CPSA requires

that certifying firms issue a certificate certifying that the product

conforms to all applicable consumer product safety standards. 15 U.S.C.

2063(a). Accordingly, the original proposal would have required the

label statement ``Complies with CPSC Safety Standard for Bicycle

Helmets (16 CFR part 1203)''.

The Commission wants to guard against the possibility that small

adult helmets will be purchased for children. Therefore, the revised

proposed standard requires that helmets that do not comply with the

requirements for young children's helmets be labeled ``Complies with

CPSC Safety Standard for Bicycle Helmets for Adults and Children Age 5

and Older (16 CFR 1203)''. Helmets intended for children 4 years of age

and younger would bear a label stating ``Complies with CPSC Safety

Standard for Bicycle Helmets for Children Under 5 Years (16 CFR

1203)''. Helmets that comply with both standards could be labeled

``Complies with the CPSC Safety Standard for Bicycle Helmets for

Persons of All Ages'', or equivalent language.

E. Recordkeeping

Section 16(b) of the CPSA requires that: [e]very person who is a

manufacturer, private labeler, or distributor of a consumer product

shall establish and maintain such records, make such reports, and

provide such information as the Commission may reasonably require for

the purposes of implementing this Act, or to determine compliance with

rules or orders prescribed under this Act.

15 U.S.C. 2065(b).

The rule as originally proposed would have required every entity

issuing certificates of compliance for bicycle helmets to maintain

written records that show the certificates are based on a reasonable

testing program. As explained below, the Commission proposes to relax

the requirement that the records be kept in written form.

These records were proposed to be maintained for a period of at

least 3 years from the date of certification of the last bicycle helmet

in each production lot and shall be available to any designated officer

or employee of the Commission upon request in accordance with

Sec. 16(b) of the CPSA, 15 U.S.C. 2065(b).

Comment: Location of test records. The original proposal required

that records be kept by the importer in the U.S. to allow inspection by

CPSC staff within 48 hours of a request by an employee of the

Commission. A commenter inquired whether test records must be kept in

the U.S. in the case of a Canadian firm that is owned by a U.S. firm,

if the records are available to the U.S. company upon request.

Response: The situation described by the commenter would achieve

the result desired by the Commission. Accordingly, the Commission has

revised the proposed regulation to state that if the importer can

provide the records to the CPSC staff within the 48-hour time period,

the records will be considered kept in the U.S.

Comment: Records on disk. The proposed regulation stated that every

person issuing a certificate of compliance for bicycle helmets shall

maintain written records that show certificates are based on a

reasonable testing program. A commenter requested that the

certification test records be allowed to be kept on disk instead of

paper.

Response: The Commission agrees with the commenter that firms

should be allowed to keep the records on disk, if the records can be

made available upon request in an appropriate format. Accordingly, the

Commission has amended the proposal to state that certification test

record results may be kept on paper, microfiche, computer disk, or

other retrievable media. Where records are kept on computer disk or

other retrievable media, the records shall be made available to the

Commission upon request on paper copies, or via electronic mail in the

same format as paper copies.

F. Regulatory Flexibility Act Certification

When an agency undertakes a rulemaking proceeding, the Regulatory

Flexibility Act, 5 U.S.C. 601 et seq., generally requires the agency to

prepare proposed and final regulatory flexibility analyses describing

the impact of the rule on small businesses and other small entities.

The purpose of the Regulatory Flexibility Act, as stated in section

2(b) (5 U.S.C. 602 note), is to require agencies, consistent with their

objectives, to fit the requirements of regulations to the scale of the

businesses, organizations, and governmental jurisdictions subject to

the regulations. Section 605 of the Act provides that an agency is not

required to prepare a regulatory flexibility analysis if the head of an

agency certifies that the rule will not have a significant economic

impact on a substantial number of small entities.

The Commission's Directorate for Economics has prepared a

preliminary economic assessment of the safety standard for bicycle

helmets. The proposed rule would establish performance requirements for

bicycle helmets. The vast majority of helmets now sold conform to one

(or more) of three existing voluntary standards. The one-time costs

associated with the redesign and testing of helmets to the new

performance standards are not known. On a per-unit basis, however,

costs associated with redesign and testing are expected to be small.

The Commission solicits comment on the costs of the redesign and

testing of bicycle helmets that would be required by the proposed

standard.

The vast majority of manufacturers now use third party testing and

monitoring for product liability reasons, and are likely to continue to

do so in the future. The proposed standard allows for self

certification and monitoring, however, which is substantially less

costly than third party testing and monitoring.

The proposed labeling requirement is unlikely to have a significant

impact on small firms, since virtually all bicycle helmets now bear a

permanent label on their inside surface. Industry sources

[[Page 62673]]

report that, given sufficient lead time to modify these labels, any

increased cost of labeling would be insignificant.

Accordingly, for the reasons given above, the Commission

preliminarily certifies that the proposed Safety Standard for Bicycle

Helmets, if promulgated, will not have any significant economic effect

on a substantial number of small entities.

G. Environmental Considerations

Pursuant to the National Environmental Policy Act, and in

accordance with the Council on Environmental Quality regulations and

CPSC procedures for environmental review, the Commission has assessed

the possible environmental effects associated with the proposed safety

standard for bicycle helmets.

The Commission's regulations at 16 CFR 1021.5(c)(1) and (2) state

that safety standards and product labeling or certification rules for

consumer products normally have little or no potential for affecting

the human environment. Preliminary analysis of the potential impact of

this proposed rule indicates that the rule is not expected to affect

preexisting packaging or materials of construction now used by

manufacturers. Existing inventories of finished products would not be

rendered unusable, since section 9(g)(1) of the CPSA provides that

standards apply only to products manufactured after the effective date.

Changes in coverage areas for helmets may require modification or

replacement of existing injection molds. However, molds are routinely

replaced due to wear or to changes in style, and modified molds could

be incorporated in this replacement process. Thus, the quantity of

discarded molds attributable to the rule is likely to be small.

Especially in view of the statutory 1-year effective date, it is

unlikely that significant stocks of current labels would require

disposal.

The requirements of the standard are not expected to have a

significant effect on the materials used in production or packaging, or

on the amount of materials discarded due to the regulation. Therefore,

no significant environmental effects are expected from the proposed

rule if it is adopted. Accordingly, neither an environmental assessment

nor an environmental impact statement is required.

H. Paperwork Reduction Act

As noted above, the requirements proposed below, if issued as a

final rule, would require U.S. manufacturers and importers of bicycle

helmets to conduct a reasonable testing program to ensure their

products comply with the standard. They are also required to keep

records of such testing so that the Commission's staff can verify that

the testing was conducted properly. This will enable the staff to

obtain information indicating that a company's helmets comply with the

standard, without having itself to test helmets. U.S. manufacturers and

importers of bicycle helmets would also have to label their products

with specified information.

For these reasons, the proposal published below contains

``collection of information requirements'' subject to the Paperwork

Reduction Act of 1995, 15 U.S.C. 3501-3520, Pub. L. 104-13, 109 Stat.

163 (1995). An agency may not conduct or sponsor, and a person is not

required to respond to, a collection of information unless it displays

a currently valid OMB control number. The control number may be

displayed by publication in the Federal Register. Accordingly, the

Commission has submitted the proposed collection of information

requirements to OMB for review under section 3507(d) of the Paperwork

Reduction Act of 1995. The title of the submission is ``Safety Standard

for Bicycle Helmets--Testing and Recordkeeping Requirements.''

The Commission's staff estimates that there are about 30

manufacturers and importers subject to these collection of information

requirements. There are an estimated 200 different models of bicycle

helmets currently marketed in the U.S.

Industry sources advise the Commission's staff that the time that

will be required to comply with the collection of information

requirements will be from 100 to 150 hours per model per year.

Therefore, the total amount of time required for compliance with these

requirements will be 20,000 to 30,000 hours per year. However, these

estimates are based on the amount of time that is currently expended in

complying with the similar requirements that are in the various

voluntary standards. Thus, the net burden of the proposed final

collection of information requirements is expected to be insignificant,

or at least a small fraction of the total hours given above. The

Commission would like to receive comments on the activities and time

required to comply with these requirements and how these differ from

usual and customary current industry practices, on the accuracy of the

Commission's burden estimate, and on how that burden could be reduced.

It is possible that firms will consider some of the records

required to be provided to the Commission upon request to be trade

secret or other confidential commercial information. Under section

6(a)(2) of the CPSA, the Commission may not disclose information that

contains or relates to a trade secret, or is of a type referred to in

18 U.S.C. 1905 or subject to 5 U.S.C. 552(b)(4). 15 U.S.C. 2055(a)(2).

Under this section and 16 CFR 1015.18-.19, persons desiring

confidential treatment for information must request that it not be

disclosed. If the Commission's staff nevertheless determines that the

information may be disclosed because it is not confidential, the person

submitting the information will be given written notice at least 10

working days before the information is released. Thus, the submitter

has an opportunity to seek judicial review of the Commission's

determination before the information is released. Also, see 16 CFR part

1101. These procedures also apply to rulemaking comments for which the

commenter seeks confidentiality.

Any person may also submit comments to OMB on these proposed

collection of information requirements. OMB is required to make a

decision concerning the collections of information contained in the

proposed rule between 30 and 60 days after publication. Thus, although

comments will be received by OMB until February 5, 1996, a comment to

OMB is best assured of having its full effect if OMB receives it by

January 5, 1996. Comments should be submitted to the Office of

Information and Regulatory Affairs of OMB, Attention: Desk Officer for

the Consumer Product Safety Commission. Persons filing comments with

OMB are encouraged to send copies to the Commission's Office of the

Secretary, with a caption or cover letter identifying the materials as

comments submitted to OMB on the proposed collection of information

requirements for bicycle helmets.

List of Subjects in 16 CFR Part 1203

Consumer protection, Bicycles, Incorporation by reference, Infants

and children, Safety.

For the reasons given above, the Commission proposes to revise Part

1203 of Title 16 of the Code of Federal Regulations, to read as

follows:

PART 1203--SAFETY STANDARD FOR BICYCLE HELMETS

Subpart A--The Standard

Sec.

1203.1 Scope and effective date.

1203.2 Purpose.

1203.3 Referenced documents.

1203.4 Definitions.

1203.5 Construction requirements - projections.

1203.6 Labeling and instructions.

[[Page 62674]]

1203.7 Samples for testing.

1203.8 Conditioning environments.

1203.9 Test headforms.

1203.10 Selecting the test headform.

1203.11 Marking the test line.

1203.12 Test requirements.

1203.13 Test schedule.

1203.14 Peripheral vision test.

1203.15 Positional stability test (roll-off resistance).

1203.16 Dynamic strength of retention system test.

1203.17 Impact attenuation test.

1203.18 Reflectivity. [Reserved]

Subpart B--Certification

1203.30 Purpose and scope.

1203.31 Effective date.

1203.32 Definitions.

1203.33 Certification testing.

1203.34 Product certification and labeling by manufacturers

(including importers).

Subpart C--Recordkeeping

1203.40 Effective date.

1203.41 Recordkeeping requirements.

Subpart D--Bicycle Helmets Manufactured From March 16, 1995, Through

Date That Is 1 Year After The Final Rule Is Issued

1203.51 Purpose.

1203.52 Scope and effective date.

1203.53 Interim safety standards.

Figures to Part 1203

Authority: Secs. 201-207, Pub. L. 103-267, 108 Stat. 726-729, 15

U.S.C. 6001-6006.

Subpart A--The Standard

Sec. 1203.1 Scope and effective date.

This standard describes test methods and defines minimum

performance criteria for protective headgear used by bicyclists. The

values stated in International System of Units (``SI'') measurements

are the standard. The inch-pound values stated in parentheses are for

information only. The standard shall become effective 1 year after

publication of the final rule and shall apply to all bicycle helmets

manufactured after that date. Bicycle helmets manufactured between

March 16, 1995, and the date that is 1 year after publication of the

final rule, inclusive, are subject to the requirements of Subpart D,

rather than this Subpart A.

Sec. 1203.2 Purpose.

The purpose and basis of this standard is to reduce the likelihood

of serious injury and death to bicyclists resulting from impacts to the

head, as provided in 15 U.S.C. 6001-6006.

Sec. 1203.3 Referenced documents.

The following documents are referenced in this standard.

(a) Draft ISO/DIS Standard 6220-1983--Headforms for Use in the

Testing of Protective Helmets.1

\1\Available from American National Standards Institute, 11 W.

42nd St., 13th Floor, New York, NY 10036.

---------------------------------------------------------------------------

(b) Federal Motor Vehicle Safety Standard 218, Motorcycle

Helmets.2

\2\Available from the Department of Transportation, National

Highway Traffic Safety Administration, Office of Vehicle Safety

Standards, 400 7th St. S.W., Washington D.C. 20590.

---------------------------------------------------------------------------

(c) SAE Recommended Practice SAE J211 OCT88, Instrumentation for

Impact Tests.3

\3\Available from Society of Automotive Engineers, 400

Commonwealth Dr., Warrendale, PA 15096.

---------------------------------------------------------------------------

Sec. 1203.4 Definitions

(a) Basic plane means an anatomical plane that includes the

auditory meatuses (the external ear openings) and the inferior orbital

rims (the bottom edges of the eye sockets). The ISO headforms are

marked with a plane corresponding to this basic plane (see Figures 1

and 2 to this part).

(b) Bicycle helmet means any headgear that either is marketed as,

or has a reasonably foreseeable use as, a device intended to provide

protection from head injuries while riding a bicycle.

(c) Comfort or fit padding means resilient lining material used to

configure the helmet for a range of different head sizes. This padding

has no significant effect on impact attenuation.

(d) Coronal plane is an anatomical plane perpendicular to both the

basic and midsagittal planes and containing the midpoint of a line

connecting the right and left auditory meatuses. The ISO headforms are

marked with a transverse plane corresponding to this coronal plane (see

Figures 1 and 2).

(e) Field of vision is the angle of peripheral vision allowed by

the helmet when positioned on the reference headform.

(f) Helmet positioning index (HPI) is the vertical distance from

the brow of the helmet to the reference plane, when placed on a

reference headform. The vertical distance shall be specified by the

manufacturer for each size of headform the helmet fits.

(g) Midsagittal plane is an anatomical plane perpendicular to the

basic plane and containing the midpoint of the line connecting the

notches of the right and left inferior orbital ridges and the midpoint

of the line connecting the superior rims of the right and left auditory

meatuses. The ISO headforms are marked with a longitudinal plane

corresponding to the midsagittal plane (see Figures 1 and 2 to this

part).

(h) Modular elastomer programmer (MEP) is a cylindrical pad,

typically consisting of a polyurethane rubber, used as a consistent

impact medium for the systems check procedure.

(i) Preload ballast is a ``bean bag'' filled with lead shot placed

on the helmet to secure its position on the headform. The mass of the

preload ballast is 5 kg (11 lb).

(j) Projection is any part of the helmet, internal or external,

that extends beyond the faired surface.

(k) Reference headform is a headform used as a measuring device and

contoured in the same configuration as one of the test headforms A, E,

J, M, and O defined in DRAFT ISO DIS 6220-1983. The reference headform

shall include surface markings corresponding to the basic, coronal,

midsagittal, and reference planes (see Figures 1 and 2 to this part).

(l) Reference plane is a plane marked on the ISO headforms at a

specified distance above and parallel to the basic plane (see Figure 3

to this part).

(m) Retention system is the complete assembly that secures the

helmet in a stable position on the wearer's head.

(n) Shield means optional equipment for helmets that is used in

place of goggles to protect the eyes.

(o) Spherical impactor is a 146 mm (5.75 in.) diameter aluminum

sphere, with a mass of 4005 5 g (8.83 1.10

lb), that is specifically machined for mounting onto the ball-arm

connector of the drop-test assembly. The impactor is used to check the

electronic equipment (see Sec. 1203.17).

(p) Test headform is a solid model in the shape of a human head of

sizes A, E, J, M, and O as defined in DRAFT ISO/DIS 6220-1983.

Headforms used for the impact attenuation test shall be constructed of

K-1A magnesium alloy or functionally equivalent metal. The test

headforms shall include surface markings corresponding to the basic,

coronal, midsagittal, and reference planes (see Figure 2 to this part).

(q) Test region is the area of the helmet, on and above a specified

test line, that is subject to impact testing.

(r) Visor (peak) is optional helmet equipment for protection

against sun or glare, and is sometimes used as a rock or dirt

deflector.

Sec. 1203.5 Construction requirements--projections.

Any unfaired projection extending more than 7 mm (0.28 in.) from

the helmet's outer surface shall break away or collapse when impacted

with forces equivalent to those produced by the applicable impact-

attenuation tests in Sec. 1203.17 of this standard. Rigid

[[Page 62675]]

projections on the inner surface shall not exceed 2 mm (0.08 in.) and

shall not make contact with the test headform after testing in

accordance with Sec. 1203.17.

Sec. 1203.6 Labeling and instructions.

(a) Labeling. Each helmet shall be marked so that the following

information is legible and easily visible to the user and is likely to

remain on the helmet and legible throughout the intended design life of

the helmet:

(1) Model designation.

(2) A warning to the user that no helmet can protect against all

possible impacts.

(3) A warning that for maximum protection the helmet must be fitted

and attached properly to the wearer's head in accordance with the

manufacturer's fitting instructions.

(4) A warning to the user that the helmet may, after receiving an

impact, be damaged to the point that it is no longer adequate to

protect the head against further impacts, and that this damage may not

be visible to the user. This label shall also state that a helmet that

has sustained an impact should be returned to the manufacturer for

competent inspection, or be destroyed and replaced.

(5) A warning to the user that the helmet can be damaged by contact

with common substances (for example, certain solvents, cleaners, etc.),

and that this damage may not be visible to the user. This label shall

also state any recommended cleaning agents and procedures, list any

known common substances that damage the helmet, and warn against

contacting the helmet with these substances.

(6) The statement ``Not For Motor Vehicle Use''.

(b) Instructions. Each helmet shall have fitting and positioning

instructions, including graphic representation of proper positioning.

Sec. 1203.7 Samples for testing.

(a) General. Helmets shall be tested in the condition in which they

are offered for sale. They must pass all tests, both with and without

any attachments that may be offered by the helmet's manufacturer, and

with all possible combinations of such attachments.

(b) Number of samples. Five samples of each size for each model and

combination of attachments offered for sale are required to test

conformance to this standard. If a helmet fits more than one size of

test headform, two additional samples are needed for each additional

headform size for the testing described in Sec. 1203.10--Selecting the

test headform.

Sec. 1203.8 Conditioning environments.

Helmets shall be conditioned to one of the following environments

prior to testing in accordance with the test schedule at Sec. 1203.13.

The barometric pressure in all conditioning environments shall be 75 to

110 kPa (22.2 to 32.6 inches of Hg). All test helmets shall be

stabilized within this ambient range for at least 4 hours prior to

further conditioning and testing. Storage or shipment within this

ambient range satisfies this requirement.

(a) Ambient condition. The ambient condition of the test laboratory

shall be within 17 deg.C to 27 deg.C (63 deg.F to 81 deg.F), and 20

to 80 percent relative humidity. The ambient test helmet does not need

further conditioning.

(b) Low temperature. The helmet shall be kept at a temperature of

-16 deg.C to -13 deg.C (3 deg.F to 9 deg.F) for 4 to 24 hours prior

to testing.

(c) High temperature. The helmet shall be kept at a temperature of

47 deg.C to 53 deg.C (117 deg.F to 127 deg.F) for 4 to 24 hours

prior to testing.

(d) Water immersion. The helmet shall be fully immersed ``crown''

down in potable water at a temperature of 17 deg.C to 27 deg.C (63

deg.F to 81 deg.F) to a crown depth of 305 mm25 mm (12

in.1 in.) for 4 to 24 hours prior to testing.

Sec. 1203.9 Test headforms.

The headforms used for testing shall be sizes A, E, J, M, and O, as

defined by DRAFT ISO/DIS 6220-1983. Headforms used for impact testing

shall be constructed of K-1A magnesium alloy or other functionally

equivalent metal and must have no resonant frequencies below 3000 hz.

Sec. 1203.10 Selecting the test headform.

A helmet shall be tested on the appropriate size(s) of headform(s)

on which it fits. Fit means that it is not physically difficult to put

the helmet on the headform, and that the helmet's comfort or fit

padding is partially compressed. A complete set of five helmets of each

size and model shall be tested on the smallest size test headform on

which they fit. Two additional helmets shall be tested on each of the

larger headforms the helmets fit. Testing on the larger headform(s)

will include at least one peripheral vision test, dynamic retention

test, positional stability test, and impact attenuation test (complete

set of four impacts) using the conditioning environment that produced

the highest g value in the impact attenuation tests on the smallest

headform the helmet fit.

Sec. 1203.11 Marking the test line.

Prior to testing, the test line shall be determined for each helmet

in the following manner.

(a) Position the helmet on the appropriate headform as specified by

the manufacturer's head positioning index (HPI), with the brow parallel

to the basic plane. Place a 5-kg (11-lb) preload ballast on top of the

helmet to set the comfort or fit padding.

(b) Draw a test line on the outer surface of the helmet coinciding

with the intersection of the surface of the helmet with the impact line

planes defined from the reference headform as shown in:

(1) Figure 4 to this part for helmets intended for adults and for

children 5 years of age and older.

(2) Figure 5 for helmets intended for children under 5 years of

age.

(c) The center of the impact sites shall be selected at any point

on the helmet on or above the test line.

Sec. 1203.12 Test requirements.

(a) Peripheral vision. The helmet shall allow unobstructed vision

through a minimum of 105 deg. to the left and right sides of the

midsagittal plane when measured in accordance with Sec. 1203.14 of this

standard.

(b) Positional stability. The helmet shall not release from the

test headform when tested in accordance with Sec. 1203.15 of this

standard.

(c) Dynamic strength of retention system. The retention system

shall remain intact without elongating more than 30 mm (1.2 in.) when

tested in accordance with Sec. 1203.16 of this standard.

(d) Impact attenuation criteria. (1) For bicycle helmets intended

for adults and children 5 years and older. The peak acceleration of any

impact shall not exceed 300 g when the helmet is tested in accordance

with Sec. 1203.17 of this standard.

(2) For bicycle helmets intended for children under 5 years. The

peak acceleration of any impact shall not exceed 250 g when the helmet

is tested in accordance with Sec. 1203.17 of this standard.

Sec. 1203.13 Test schedule.

(a) One of the set of five helmets shall be tested for peripheral

vision in accordance with Sec. 1203.14 of this standard.

(b) Helmet samples 1 through 4 shall be conditioned in the ambient,

high temperature, low temperature, and water immersion environments,

respectively. Helmet 5 shall be conditioned in the ambient condition.

(c) Testing must begin within 2 minutes after the helmet is removed

[[Page 62676]]

from the conditioning environment. The helmet shall be returned to the

conditioning environment within 3 minutes after it was removed for a

minimum of 2 minutes before testing is resumed. If the helmet is out of

the conditioning environment for longer than 3 minutes, it shall be

reconditioned for 5 minutes for each minute it is out of the

conditioning environment beyond the allotted 3 minutes before testing

is resumed.

(d) Helmets shall be tested for dynamic strength of the retention

system prior to being tested for impact attenuation. Helmets 1 through

4 (conditioned in ambient, high temperature, low temperature, and water

immersion environments) shall be tested in accordance with the dynamic

retention system strength test at Sec. 1203.16. Helmets 1 through 4

shall then be tested in accordance with the impact attenuation tests on

the flat, hemispherical, and curbstone anvils in accordance with the

procedure at Sec. 1203.17. Helmet 5 (conditioned in an ambient

environment) shall be tested in accordance with the positional

stability tests at Sec. 1203.15. Table 1203.13 summarizes the test

schedule.

Table 1203.13.--Test Schedule

----------------------------------------------------------------------------------------------------------------

Sec. 1203.17

Sec. 1203.14 Sec. 1203.15 Sec. 1203.16 Impact tests--4

Peripheral Positional Retention impacts per

vision stability system strength helmet

----------------------------------------------------------------------------------------------------------------

Helmet 1--Ambient......................... X ............... X 1 Flat X

1Hemi. X

1 Curb. X

1 TBD* X

Helmet 2--High Temperature................ ............... ............... X 1 Flat X

1 Hemi. X

1 Curb. X

1 TBD* X

Helmet 3--Low Temperature................. ............... ............... X 1 Flat X

1 Hemi. X

1 Curb. X

1 TBD* X

Helmet 4--Water Immersion................. ............... ............... X 1 Flat X

1 Hemi. X

1 Curb. X

1 TBD* X

Helmet 5--Ambient......................... X X

----------------------------------------------------------------------------------------------------------------

* To Be Determined. The fourth impact can be on any of the anvils, at the discretion of the test personnel.

Sec. 1203.14. Peripheral vision test.

Position the helmet on a reference headform in accordance with the

HPI and place a 5-kg (11-lb) preload ballast on top of the helmet to

set the comfort or fit padding. (Note: Peripheral vision clearance may

be determined when the helmet is positioned for marking the test

lines.) Peripheral vision is measured horizontally from each side of

the midsagittal plane around the point K (see Figure 6 to this part).

Point K is located on the front surface of the reference headform at

the intersection of the basic and midsagittal planes. The vision shall

not be obstructed within 105 degrees on each side of the midsagittal

plane from point K.

Sec. 1203.15 Positional stability test (roll-off resistance).

(a) Test equipment. (1) Headforms. The geometry of the test

headforms shall comply with the dimensions of the full chin ISO

reference headforms sizes A, E, J, M, and O.

(2) Test fixture. The headform shall be secured in a test fixture

with its vertical axis pointing downward and 45 degrees to the

direction of gravity (see Figure 7 to this part). The test fixture

shall permit rotation of the headform about its vertical axis and

include means to lock the headform in the face up and face down

positions.

(3) Dynamic impact apparatus. A dynamic impact apparatus shall be

used to apply a shock load to a helmet secured to a test headform. The

dynamic impact apparatus shall allow a 4-kg (8.8-lb) drop weight to

slide in a guided free fall to impact a rigid stop anvil (see Figure

7). The entire mass of the dynamic impact assembly, including the drop

weight, shall be no more than 5 kg (11 lb).

(4) Strap or cable. A hook and flexible strap or cable shall be

used to connect the dynamic impact apparatus to the helmet. The strap

or cable shall be of a material having an elongation of no more than 5

mm (0.20 in.) per 300 mm (11.8 in.) when loaded with a 22-kg (48.5 lb)

weight in a free hanging position.

(b) Test procedure. (1) Orient the headform so that its face is

down, and lock it in that orientation.

(2) Place the helmet on the appropriate size full chin headform in

accordance with the HPI and fasten the retention system in accordance

with the manufacturer's instructions. Adjust the straps to remove any

slack.

(3) Suspend the dynamic impact system from the helmet by

positioning the flexible strap over the helmet along the midsagittal

plane and attaching the hook over the edge of the helmet as shown in

Figure 7.

(4) Raise the drop weight to a height of 0.6 m (2 ft) from the stop

anvil and release it, so that it impacts the stop anvil.

(5) The test shall be repeated with the headform face pointing

upwards, so that the helmet is pulled from front to rear.

Sec. 1203.16 Dynamic strength of retention system test.

(a) Test equipment. (1) ISO headforms without the lower chin

portion shall be used.

(2) The retention system strength test equipment shall consist of a

dynamic impact apparatus that allows a 4-kg (8.8-lb) drop weight to

slide in a guided free fall to impact a rigid stop anvil (see Figure

8). Two cylindrical rollers that spin freely, with a diameter of

12.50.5 mm (0.49 in.0.02 in.) that have a

center-to-center distance of 76.01 mm (3.00.04

in.), shall make up a stirrup that represents the bone structure of the

[[Page 62677]]

lower jaw. The entire dynamic test apparatus hangs freely on the

retention system. The entire mass of the support assembly, including

the 4-kg (8.8-lb) drop weight, shall be 11 kg0.5 kg (24.2

lb1.1 lb).

(b) Test procedure. (1) Place the helmet on the appropriate size

headform on the test device according to the HPI. Fasten the strap of

the retention system under the stirrup.

(2) Mark the pre-test position of the retention system, with the

entire dynamic test apparatus hanging freely on the retention system.

(3) Raise the 4-kg (8.8-lb) drop weight to a height of 0.6 m (2 ft)

from the stop anvil and release it, so that it impacts the stop anvil.

(4) Record the maximum elongation of the retention system during

the impact. A marker system or a displacement transducer, as shown in

Figure 8, are two methods of measuring the elongation.

Sec. 1203.17 Impact attenuation test.

(a) Test instruments and equipment. (1) Measurement of impact

attenuation. Impact attenuation is determined by measuring the

acceleration of the test headform during impact. Acceleration is

measured with a uniaxial accelerometer that is capable of withstanding

a shock of at least 1000 g. The helmet is secured onto the headform and

dropped in a guided free fall, using a monorail test apparatus (see

Figure 9), onto an anvil fixed to a rigid base. The base shall consist

of a solid mass of at least 135 kg (298 lb), the upper surface of which

shall consist of a steel plate at least 12 mm (0.47 in.) thick and

having a surface area of at least 0.10 m\2\ (1.08 ft\2\).

(2) Accelerometer. A uniaxial accelerometer is mounted at the

center of gravity of the test headform, with the sensitive axis aligned

within 5 degrees of vertical when the test headform is in the impact

position. The acceleration data channel and filtering shall comply with

SAE Recommended Practice J211 OCT88, Instrumentation for Impact Tests,

Requirements for Channel Class 1000.

(3) Headform and drop assembly--centers of gravity. The center of

gravity of the test headform is located at the center of the mounting

ball on the support assembly and lies within an inverted cone with its

axis vertical, and forming a 10 degree included angle with the vertex

at the point of impact. The location of the center of gravity of the

drop assembly (combined test headform and support assembly) must meet

FMVSS 218 S7.1.8. The center of gravity of the drop assembly lies

within the rectangular volume bounded by x = -6.4 mm (-0.25 in.), x =

21.6 mm (0.85 in), y = 6.4 mm (0.25 in.), and y = -6.4 mm (-0.25 in),

with the origin located at the center of gravity of the test headform.

The rectangular volume has no boundary along the z-axis. The x-y-z axes

are mutually perpendicular and have positive or negative designations

in accordance with the right-hand rule. The origin of the coordinate

axes is located at the center of the mounting ball on the support

assembly. The x-y-z axes of the test headform assembly on monorail

impact-test equipment are oriented as follows: From the origin, the x-

axis is horizontal with its positive direction going toward and passing

through the vertical centerline of the monorail. The positive z-axis is

downward. The y-axis also is horizontal, and its direction is decided

by the z- and x-axes, using the right-hand rule. See Figure 10 for an

overhead view of the x-y boundary of the location of the center of

gravity.

(4) Drop assembly. The center of gravity of the headform shall be

at the center of the mounting ball.

(i) Mass of the drop assembly for testing helmets for adults and

children 5 years of age and older. The combined mass of the

instrumented test headform and support assembly (excluding the test

helmet) for the impact test shall be 5.0 0.1 kg (11.00

0.22 lb).

(ii) Mass of the drop assembly for testing helmets for children

under 5 years. The combined mass of the instrumented test headform (ISO

A or ISO E) and support assembly (excluding the test helmet) for the

impact test shall be 3.9 0.1 kg (8.60 0.22 lb).

(5) Impact anvils. Impact tests shall be performed against the

three different anvils described below. All of the anvils shall be

constructed of steel and shall be solid (i.e., without internal

cavities).

(i) Flat Anvil. The flat anvil shall have a flat surface area with

an impact face having a minimum diameter of 125 mm (4.92 in.) and shall

be at least 24 mm (0.94 in.) thick (see Figure 11).

(ii) Hemispherical anvil. The hemispherical anvil shall have an

impact surface with a radius of 48 1 mm (1.89

0.04 in.). The profile of the impact surface shall be one

half the surface of a sphere (see Figure 12).

(iii) Curbstone anvil. The curbstone anvil shall have two flat

faces making an angle of 105 degrees and meeting along a striking edge

with a radius of 15 mm 0.5 mm (0.59 0.02 in.).

The height of the curbstone anvil shall not be less than 50 mm (1.97

in.), and the length shall not be less than 200 mm (7.87 in.) (see

Figure 13).

(b) Test Procedure. (1) Instrument system check. The impact-

attenuation test instrumentation shall be checked before and after each

series of tests (at least at the beginning and end of each test day) by

dropping an impactor with a spherical impact surface onto an

elastomeric test medium (MEP). The impactor shall be dropped onto the

MEP at a specified impact velocity (2% of a central value)

that is representative of helmet testing drop heights. Before

conducting a series of drops, the center vertical axis of the

accelerometer (see Sec. 1203.17(a)(2)) shall be aligned with the

geometric center of the MEP pad. Six impacts, at intervals of 75

15 seconds, shall be performed at the beginning and end of

the day. The first three impacts at the beginning and end of the day

shall be considered warm-up drops and shall be discarded from the

series. The test parameters selected at each laboratory shall produce

impact accelerations shown to be repeatable within 2% of a

central value.

(2) Impact sites. Each of helmets 1 through 4 (one helmet for each

conditioning environment) shall impact at four different sites, one

impact on the flat anvil, one impact on the hemispherical anvil, one

impact on the curbstone anvil, and one impact on an anvil chosen at the

discretion of the test personnel.4 The center of any impact may be

on or anywhere above the test line, provided it is at least 120 mm

(4.72 in), measured on the surface of the helmet, from any prior impact

center. Rivets and other mechanical fasteners, vents, and any other

helmet feature within the test region are valid test sites.

\4\The intent of this requirement is that the fourth impact will

be on the anvil likely to result in the highest g-value. In the

absence of an indication why another anvil would be more stringent,

this fourth impact should be made with the anvil that produced the

highest g-value in the previous three impacts.

---------------------------------------------------------------------------

(3) Impact velocity. The helmet shall be dropped onto the flat

anvil from a theoretical drop height of 2 meters (6.56 ft) to achieve

an impact velocity of 6.2 m/s 3% (20.34 ft/s

3%). The helmet shall be dropped onto the hemispherical and

curbstone anvils from a theoretical drop height of 1.2 meters (3.94 ft)

to achieve an impact velocity of 4.8 m/s 3% (15.75 ft/s

3%). The impact velocity shall be measured during the last

40 mm (1.57 in) of free-fall for each test.

(4) Helmet position. Prior to each test, the helmet shall be

positioned on the test headform in accordance with the HPI. The helmet

shall be secured so that it does not shift position prior to impact.

The helmet retention system shall be secured in a manner that does not

interfere with free-fall or impact.

[[Page 62678]]

(5) Data. Record the maximum acceleration in g's during impact.

Sec. 1203.18 Reflectivity. [Reserved]

Subpart B--Certification

Sec. 1203.30 Purpose and scope.

(a) Purpose. Section 14(a) of the Consumer Product Safety Act

(CPSA), 15 U.S.C. 2063(a), requires every manufacturer (including

importers) and private labeler of a product which is subject to a

consumer product safety standard to issue a certificate that the

product conforms to the applicable standard. Section 14(a) further

requires that the certificate be based either on a test of each product

or on a ``reasonable testing program.'' The purpose of this subpart is

to establish requirements that manufacturers and importers of bicycle

helmets subject to the Safety Standard for Bicycle Helmets (Subpart A

of this Part 1203) shall issue certificates of compliance in the form

specified.

(b) Scope. The provisions of this subpart apply to all bicycle

helmets that are subject to the requirements of the Safety Standard for

Bicycle Helmets.

Sec. 1203.31 Effective date.

Any bicycle helmet manufactured more than 1 year after publication

of a final rule must meet the standard and must be certified as

complying with the standard in accordance with this Subpart B.

Sec. 1203.32 Definitions.

The following definitions shall apply to this subpart:

(a) Foreign manufacturer means an entity that manufactured a

bicycle helmet outside the United States.

(b) Manufacturer means the entity that either manufactured a helmet

in the United States or imported a helmet manufactured outside the

United States.

(c) Private labeler means an owner of a brand or trademark that is

used on a bicycle helmet subject to the standard and which is not the

brand or trademark of the manufacturer of the bicycle helmet, provided

the owner of the brand or trademark caused, authorized, or approved its

use.

(d) Production lot means a quantity of bicycle helmets from which

certain bicycle helmets are selected for testing prior to certifying

the lot. All bicycle helmets in a lot must be essentially identical in

those design, construction, and material features that relate to the

ability of a bicycle helmet to comply with the standard.

(e) Reasonable testing program means any tests which are identical

or equivalent to, or more stringent than, the tests defined in the

standard and which are performed on one or more bicycle helmets

selected from the production lot to determine whether there is

reasonable assurance that all of the bicycle helmets in that lot comply

with the requirements of the standard.

Sec. 1203.33 Certification testing.

(a) General. Manufacturers, as defined in Sec. 1203.32(a), shall

conduct a reasonable testing program to demonstrate that their bicycle

helmets comply with the requirements of the standard.

(b) Reasonable testing program. This paragraph provides guidance

for establishing a reasonable testing program.

(1) Manufacturers and importers may define their own reasonable

testing programs. Reasonable testing programs may, at the option of

manufacturers and importers, be conducted by an independent third party

qualified to perform such testing programs. However, manufacturers, as

defined in Sec. 1203.32(a), are responsible for insuring compliance

with all requirements of this standard.

(2) To conduct a reasonable testing program, the bicycle helmets

shall be divided into production lots. Sample bicycle helmets from each

production lot shall be tested in accordance with the reasonable

testing program. Whenever there is a change in parts, suppliers of

parts, or production methods that could affect the ability of the

bicycle helmet to comply with the requirements of the standard, the

manufacturer shall establish a new production lot for testing.

(3) The Commission will test for compliance with the standard by

using the standard's test procedures. However, a reasonable testing

program need not be identical to the tests prescribed in the standard.

(4) If the reasonable testing program shows that a bicycle helmet

may not comply with one or more requirements of the standard, no

bicycle helmet in the production lot can be certified as complying

until all noncomplying bicycle helmets in the lot have been identified

and destroyed or altered by repair, redesign, or use of a different

material or components to the extent necessary to make them conform to

the standard.

(5) The sale or offering for sale of a bicycle helmet that does not

comply with the standard is a prohibited act and a violation of

Sec. 19(a) of the CPSA (15 U.S.C. 2068(a)), regardless of whether the

bicycle helmet has been validly certified.

Sec. 1203.34 Product certification and labeling by manufacturers

(including importers).

(a) Form of permanent label of certification. Manufacturers, as

defined in Sec. 1203.32(a), shall issue certificates of compliance for

bicycle helmets manufactured after the effective date of the standard

in the form of a legible and readily visible label which can reasonably

be expected to remain on the bicycle helmet and legible for the

intended design life of the helmet. Such labeling shall be deemed to be

a certificate of compliance, as that term is used in Sec. 14 of the

CPSA, 15 U.S.C. 2063.

(b) Contents of certification label. The certification labels

required by this section shall contain the following:

(1) The statement ``Complies with CPSC Safety Standard for Bicycle

Helmets for Adults and Children Age 5 and Older (16 CFR 1203)'' or

``Complies with CPSC Safety Standard for Bicycle Helmets for Children

Under 5 Years (16 CFR 1203)'', as appropriate (for a helmet that meets

the criteria for both an adult helmet and a helmet for children under

age 5, the label may state ``Complies with the CPSC Safety Standard for

Bicycle Helmets for Persons of All Ages'', or equivalent language);

(2) The name of the U.S. manufacturer or importer responsible for

issuing the certificate;

(3) The address of the U.S. manufacturer or importer responsible

for issuing the certificate or, if the name of a private labeler is on

the label, the address of the private labeler;

(4) The name and address of the foreign manufacturer, if the helmet

was manufactured outside the United States;

(5) An identification of the production lot; and

(6) The month and year the product was manufactured.

(c) Coding. (1) The information required by paragraphs (b) (4)

through (6) of this section may be in code, provided:

(i) the person or firm issuing the certificate maintains a written

record of the meaning of each symbol used in the code, and

(ii) the record shall be made available to the distributor,

retailer, consumer, and Commission upon request.

(2) A serial number may be used in place of a production lot

identification on the helmet if it can serve as a code to identify the

production lot. If a bicycle helmet is manufactured for sale by a

private labeler, and if the name of the private labeler is on the

certification label, the name of the manufacturer or importer issuing

the certificate, and the name and address of any foreign

[[Page 62679]]

manufacturer, may also be in such a code.

(d) Placement of the label(s). The information required by

paragraphs (b) (2) through (3) must be on one label, unless allowed to

be in code. The other required information may be on separate labels.

The label(s) required by this section must be affixed to the bicycle

helmet. If the label(s) are not immediately visible to the ultimate

purchaser of the bicycle helmet prior to purchase because of packaging

or other marketing practices, a second label is required. That label

shall state, as appropriate, ``Complies with CPSC Safety Standard for

Bicycle Helmets for Adults and Children Age 5 and Older'', or

``Complies with CPSC Safety Standard for Bicycle Helmets for Children

Under 5 Years''. The additional label must appear on the container or,

if the container is not visible before purchase, on the promotional

material used with the sale of the bicycle helmet. (For a helmet that

meets the criteria for both an adult helmet and a helmet for children

under age 5, the label may state ``Complies with the CPSC Safety

Standard for Bicycle Helmets for Persons of All Ages'', or equivalent

language.)

(e) Additional provisions for importers.

(1) General. The importer of any bicycle helmet subject to the

standard in Subpart A of this Part 1203 must issue the certificate of

compliance required by Sec. 14(a) of the CPSA and this section.

(i) If a reasonable testing program meeting the requirements of

this subpart has been performed by or for the foreign manufacturer of

the product, the importer may rely in good faith on such tests to

support the certificate of compliance provided:

(A) the importer is a resident of the United States or has a

resident agent in the United States,

(B) the records of such tests required by Sec. 1203.41 of Subpart C

of this part are maintained in the United States, and

(C) such records are available to the Commission upon request to

the importer.

(ii) Test records may be maintained outside of the United States if

they will be provided to the Commission within 48 hours of a request

for the records.

(2) Responsibility of importer. If the importer relies on tests by

the foreign manufacturer to support the certificate of compliance, the

importer shall--in addition to complying with paragraph (e(1)of this

section--examine the records supplied by the manufacturer to determine

that they comply with Sec. 1203.41 of Subpart C of this part.

Subpart C--Recordkeeping

Sec. 1203.40 Effective date.

The recordkeeping requirements in this subpart are effective [1

year after publication of the final rule] and apply to bicycle helmets

manufactured after that date.

Sec. 1203.41 Recordkeeping requirements.

(a) General. Every person issuing certificates of compliance for

bicycle helmets subject to the standard in Subpart A of this part shall

maintain records which show that the certificates are based on a

reasonable testing program. The records shall be maintained for a

period of at least 3 years from the date of certification of the last

bicycle helmet in each production lot. These records shall be

available, upon request, to any designated officer or employee of the

Commission, in accordance with Sec. 16(b) of the CPSA, 15 U.S.C.

2065(b).

(b) Contents of records. Complete test records shall be maintained.

Records shall contain the following information.

(1) An identification of the bicycle helmets tested;

(2) An identification of the production lot;

(3) The results of the tests, including the precise nature of any

failures;

(4) A description of the specific actions taken to address any

failures;

(5) A detailed description of the tests;

(6) The manufacturer's name and address;

(7) The model and size of each helmet tested;

(8) Identifying information for each helmet tested, including the

production lot for each helmet, and the environmental condition under

which each helmet was tested;

(9) The temperatures in each conditioning environment, and the

relative humidity and temperature of the laboratory;

(10) The peripheral vision clearance;

(11) A description of any failures to conform to any of the

labeling and instruction requirements;

(12) Performance impact results, stating the location of impact,

type of anvil used, velocity prior to impact, and maximum acceleration

measured in g's;

(13) The results of the positional stability test;

(14) The results of the dynamic strength of retention system test;

(15) The name and location of the test laboratory;

(16) The name of the person(s) who performed the test;

(17) The date of the test; and

(18) The system check results.

(c) Format for records. The records required to be maintained by

this section may be in any appropriate form or format that clearly

provides the required information. Certification test results may be

kept on paper, microfiche, computer disk, or other retrievable media.

Where records are kept on computer disk or other retrievable media, the

records shall be made available to the Commission on paper copies, or

via electronic mail in the same format as paper copies, upon request.

Subpart D--Bicycle Helmets Manufactured From March 16, 1995,

Through Date That Is 1 Year After the Final Rule Is Issued

Sec. 1203.51 Purpose and basis.

The purpose and basis of this rule is to protect bicyclists from

head injuries by ensuring that bicycle helmets comply with the

requirements of appropriate existing voluntary standards, as provided

in 15 U.S.C. 6004(a).

Sec. 1203.52 Scope and effective date.

(a) Bicycle helmets manufactured after March 16, 1995, through the

date that is 1 year after issuance of the final standard (Subparts A,

B, and C) shall comply with the requirements of one of the standards

specified in Sec. 1203.53. This requirement shall be considered a

consumer product safety standard issued under the Consumer Product

Safety Act.

(b) The term ``bicycle helmet'' is defined at Sec. 1203.4(b).

(c) These interim mandatory safety standards will not apply to

bicycle helmets manufactured after the effective date of the final

bicycle helmet standard.

Sec. 1203.53 Interim safety standards.

(a) Bicycle helmets must comply with one or more of the following

standards, which are incorporated herein by reference:

(1) American National Standards Institute (ANSI) standard Z90.4-

1984, Protective Headgear for Bicyclists,

(2) ASTM standards F 1447-93 or F 1447-94, Standard Specification

for Protective Headgear Used in Bicycling, incorporating the relevant

provisions of ASTM F 1446-93 or ASTM F 1446-94, Standard Test Methods

for Equipment and Procedures Used in Evaluating the Performance

Characteristics of Protective Headgear, respectively,

(3) Canadian Standard Association standard, Cycling Helmets--CAN/

CSA-D113.2-M89,

(4) Snell Memorial Foundation (Snell) 1990 Standard for Protective

Headgear for Use in Bicycling (designation B-90),

(5) Snell 1990 Standard for Protective Headgear for Use in

Bicycling, including

[[Page 62680]]

March 9, 1994 Supplement (designation B-90S),

(6) Snell 1994 Standard for Protective Headgear for Use in Non-

Motorized Sports (designation N-94), or

(7) Snell 1995 standard for Protective Headgear for Use with

Bicycles B-95.

(b) This incorporation by reference was approved by the Director of

the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR Part

51. Copies of the standards may be obtained as follows. Copies of the

ANSI Z90.4 standard are available from: American National Standards

Institute, 11 W. 42nd Street, 13th Floor, New York, NY 10036. Copies of

the ASTM standards are available from: ASTM, 1916 Race Street,

Philadelphia, PA 19103. Copies of the Canadian Standards Association

CAN/CSA-D113.2-M89 standard are available from: CSA, 178 Rexdale

Boulevard, Rexdale (Toronto), Ontario, Canada, M9W 1R3. Copies of the

Snell standards are available from: Snell Memorial Foundation, Inc.,

P.O. Box 493, 7 Flowerfield, Suite 28, St. James, New York 11780.

Copies may be inspected at the Office of the Secretary, Consumer

Product Safety Commission, 4330 East-West Highway, Bethesda, Maryland

20814, or at the Office of the Federal Register, 800 N. Capitol Street

NW, Room 700, Washington, DC.

Figures to Part 1203

BILLING CODE 6355-01-U

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Dated: November 13, 1995.

Sadye E. Dunn,

Secretary, Consumer Product Safety Commission.

[FR Doc. 95-28761 Filed 12-5-95; 8:45am]

BILLING CODE 6355-01-C