Safety Standard for Bicycle Helmets

Federal RegisterMar 10, 1998

Ask Donna

What actually matters in this document.

Text

SUMMARY: Pursuant to the Children's Bicycle Helmet Safety Act of 1994,

the Commission is issuing a safety standard that will require all

bicycle helmets to meet impact-attenuation and other requirements.

The standard establishes requirements derived from one or more of

the voluntary standards applicable to bicycle helmets. In addition, the

standard includes requirements specifically applicable to children's

helmets and requirements to prevent helmets from coming off during an

accident. The standard also contains testing and recordkeeping

requirements to ensure that bicycle helmets meet the standard's

requirements.

DATES: Effective Date: This rule is effective March 10, 1999.

Applicability Dates: This rule applies to bicycle helmets

manufactured after March 10, 1999. Interim mandatory standards that

went into effect on March 17, 1995, will continue to apply to bicycle

helmets manufactured from March 17, 1995, until March 10, 1999,

inclusive. In addition, as of March 10, 1998, firms will have the

option of marketing helmets meeting the standard in this final rule

before its effective date.

Incorporation by Reference: The incorporation by reference of

certain publications listed in the rule is approved by the Director of

the Federal Register as of March 10, 1999.

FOR FURTHER INFORMATION CONTACT: Frank Krivda, Office of Compliance,

Consumer Product Safety Commission, Washington, D.C. 20207; telephone

(301) 504-0400 ext. 1372.

SUPPLEMENTARY INFORMATION:

Outline of Contents

A. Introduction and Background

1. Introduction.

2. Injury and death data.

3. The Children's Bicycle Helmet Safety Act of 1994.

4. The current rulemaking proceeding.

B. Overall Description of Standard

1. Impact attenuation.

2. Children's helmets: head coverage.

3. Retention system.

4. Peripheral vision.

5. Labels and instructions.

6. Positional stability (roll off).

7. Certification labels and testing program.

8. Recordkeeping.

9. Interim standards.

C. The Final Standard--Comments, Responses, and Other Changes

1. Accident scenarios.

2. Future revisions.

3. Compliance with third-party standards as compliance with the

rule.

4. Scope of the standard.

a. Definition of ``bicycle helmet.''

b. Multi-activity helmets.

5. Projections.

6. Requirements for qualities of fitting pads.

7. Impact attenuation criteria.

a. Extent of protection.

b. Distance between impacts.

c. Impact velocity tolerance.

d. Other children's requirements: peak g-value and drop mass.

8. Impact attenuation test rig.

a. Type of test rig.

b. Accuracy check.

c. Test headform characteristics.

d. Alignment of anvils.

e. Definition of ``spherical impactor.''

9. Impact attenuation test procedure.

a. Anvil test schedule and use of curbstone anvil.

b. Definition of ``comfort padding.''

c. Testing on more than one headform.

d. Number of helmets required for testing.

10. Helmet conditioning.

a. Low-temperature environment: temperature range.

b. Water immersion environment.

c. Reconditioning time.

11. Labels.

a. Label format and content.

b. Use label.

c. Labeling for cleaning products.

d. Warning to replace after impact.

e. Durability of labels.

f. Labels on both helmets and boxes.

12. Instructions for fitting children's helmets.

13. Retention system strength test.

14. Positional stability test.

15. Vertical vision.

16. Reflectivity.

17. Hard-shell requirements.

D. Certification Testing and Labeling

1. General.

2. The certification rule.

3. Reasonable testing program.

a. Changes in materials or vendors.

b. Pre-market clearance and market surveillance.

4. Certificate of compliance.

a. Coding date of manufacture.

b. Telephone number on label.

c. Certification label on children's helmets.

d. Minimum age on labels for children's helmets.

e. Identifying the Commission.

f. Certification label on packaging.

E. Recordkeeping

1. General.

2. Location of test records--time for production.

3. Length of records retention.

F. Regulatory Flexibility Act Certification

G. Environmental Considerations

H. Paperwork Reduction Act

I. Executive Orders

List of Subjects in 16 CFR Part 1203

Part 1203--Safety Standard for Bicycle Helmets

A. Introduction and Background

1. Introduction

In this notice, the United States Consumer Product Safety

Commission (``Commission'' or ``CPSC'') issues a mandatory safety

standard for bicycle helmets.1

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

\1\ The standard was approved by the Commission unanimously, by

a vote of 3-0. Chairman Anne Brown, Commissioner Mary S. Gall, and

Commissioner Thomas Moore each issued a separate statement

concerning the vote. Copies of these statements are available from

the Office of the Secretary.

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

2. Injury and Death Data

Data from the National Center for Health Statistics (``NCHS'')

indicated that in 1993 there were 907 pedalcyclist (primarily bicycle-

related) deaths in the United States. Of these, 17 (about 2%) were of

children under the age of 5 years. Research has shown that

approximately 60% of all bicycle-related deaths involved head injury.

For children under age 5, about 64% involved head injury.2

Information on the impact forces involved in these fatal incidents was

not available, although about 90% of the pedalcyclist deaths, including

those of children under age 5, involved collisions with motor vehicles.

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

\2\ Sacks, Jeffrey, J., MPH; Holmgreen, Patricia, MS; Smith,

Suzanne M., MD; Sosin, Daniel M., MD. ``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. Sosin, Daniel M., MD, MPH; Sacks, Jeffrey J., MD, MPH;

and Webb, Kevin W., ``Pediatric Head Injuries and Deaths from

Bicycling in the United States,'' Pediatrics 98 (November 1996):

868-870.

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

Based on data from CPSC's National Electronic Injury Surveillance

System (``NEISS''), there were an estimated 566,400 bicycle-related

injuries treated in U.S. hospital emergency rooms in 1996. Of these,

approximately 30% involved the head and face. A higher proportion of

head injuries and facial injuries occurred to young children than to

older victims.

CPSC's NEISS data showed that the types of injuries to young

children were somewhat different from those to older children and

adults. Younger children had a smaller proportion of concussions and

internal injuries to the head than did older victims, as well as a

larger proportion of relatively minor head injuries (i.e., lacerations,

contusions, and abrasions). The extent to which these differences can

be attributed to the use of helmets, other aspects of the hazard

scenario, or the physiology of young children, is not known. It is also

possible that caregivers are more likely to bring young children to the

emergency room for relatively minor injuries.

[[Page 11713]]

A 1993 Commission staff study of bicycle hazards indicated that

when other factors were held constant statistically, the injury risk

for children under age 15 was over five times the risk for older

riders.3 This study also indicated that children were at

particular risk of head injury. About one-half of the injuries to

children under age 10 involved the head, compared to one-fifth of the

injuries to older riders. This may have been in part because children

were significantly less likely to have been wearing a helmet than were

older victims (5% of victims younger than 15 were wearing a helmet,

compared to 30% of those 15 and older). However, detailed information

relating the type of helmet, age of user, and other aspects of the

hazard scenario to head injury severity was not available from that

study. A Commission study on bicycle and helmet usage patterns found

that in 1993 about 18% of bicyclists wore helmets.4

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

\3\ Tinsworth, Deborah K., MS; Polen, Curtis; and Cassidy,

Suzanne. ``Bicycle-Related Injuries: Injury, Hazard, and Risk

Patterns,'' International Journal for Consumer Safety I (December

1994): 207-220.

\4\ Rogers, Gregory B. ``The Characteristics and Use Patterns of

Bicycle Riders in the United States,'' Journal of Safety Research 25

(1994): 83-96.

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

A 1996 study of about 3,400 injured bicyclists in the Seattle,

Washington, area included an evaluation of the protective effectiveness

of helmets in different age groups.5 When bicyclists treated

in hospital emergency rooms for head injuries were compared to

bicyclists who sought care for other types of injuries at the same

emergency rooms, helmet use was associated with a reduction in the risk

of any head injury by 69%, brain injury by 65%, and severe brain injury

by 74%.

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

\5\ Thompson, Diane C., MS; Rivara, Frederick P., MD, MPH; and

Thompson, Robert S., MD. ``Effectiveness of Bicycle Safety Helmets

in Preventing Head Injuries,'' Journal of the American Medical

Association 276 (December 1996): 1968-1973.

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

By age group, this study showed that the reduction in the risk of

head injury ranged from 73% for children under 6 years to 59% for teens

in the 13-19 year-old age group.6 Based on the results of

their study, the authors concluded that helmets were effective for all

bicyclists, regardless of age, and that there was no evidence that

children younger than 6 years need a different type of helmet. However,

for children younger than 6 years, there was only one helmeted child

with a brain injury (a concussion), and no helmeted children with

severe brain injuries. Thus, the protective effects of helmets on brain

injuries and severe brain injuries were not calculated for this age

group.

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

\6\ The estimated reduction in risk for children 6-12 years of

age was 70%.

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

A widely-cited 1989 study, published by the same authors, found

that riders with helmets had an 85% reduction in their risk of head

injury, and an 88% reduction in their risk of brain injury, when

compared to cyclists without helmets.7 These results were

found when patients who sought emergency room care for bicycle-related

head injuries were compared to bicyclists in the community who had

crashes, regardless of injury or medical care. A recent study indicated

that helmets may protect more against head injuries than against some

facial injuries.8

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

\7\ Thompson, Robert S., MD; Rivara, Frederick P., MD, MPH; and

Thompson, Diane C., MS. ``A Case Control Study of the Effectiveness

of Bicycle Safety Helmets,'' The New England Journal of Medicine 320

(May 1989): 1361-1367.

\8\ Recent research indicated that helmets reduced the risk of

serious injury to the upper and middle face by about 65%, but had no

significant effect on serious injury to the lower face. Thompson,

Diane C., MS; Nunn, Martha E., DDS; Thompson, Robert S., MD; and

Rivara, Frederick P., MD, MPH. ``Effectiveness of Bicycle Safety

Helmets in Preventing Serious Facial Injury.'' Journal of the

American Medical Association 276 (December 1996): 1974-1975.

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

3. The Children's Bicycle Helmet Safety Act of 1994

On June 16, 1994, the Children's Bicycle Helmet Safety Act of 1994

(the ``Act'' or ``the Bicycle Helmet Safety Act'') became law. 15

U.S.C. 6001-6006. The Act provides that bicycle helmets manufactured

after March 16, 1995, 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.

The Act directed the Consumer Product Safety Commission to begin a

proceeding under the Administrative Procedure Act, 5 U.S.C. 553, to:

a. Review the requirements of the interim standards described above

and establish a final standard based on such requirements;

b. Include in the final standard a provision to protect against the

risk of helmets coming off the heads of bicycle riders;

c. Include in the final standard provisions that address the risk

of injury to children; and

d. Include additional provisions as appropriate. 15 U.S.C. 6004(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). The Act further provides

that the final standard shall be considered to be a consumer product

safety standard issued under the CPSA. Section 9(g)(1) of the CPSA

provides that a ``consumer product safety standard shall be applicable

only to consumer products manufactured after the effective date.''

Thus, the final standard, which the Commission is issuing in this

notice, will become effective March 10, 1999, as to products

manufactured after that date. The Act also 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.

The Act states that the CPSA's provisions regarding rulemaking

procedures, statutory findings, and judicial review (15 U.S.C. 2056,

2058, 2060, and 2079(d)) shall not apply to the final standard or its

rulemaking proceeding. 15 U.S.C. 6004(c).

The final rule is codified at 16 CFR 1203 and will replace the

interim standards as to bicycle helmets manufactured on or after March

11, 1999. 15 U.S.C. 6004(d). In addition, the final standard is also

being designated an interim standard, so that firms will have the

option of marketing helmets meeting CPSC's final standard before its

effective date. Because providing this additional interim standard is a

substantive rule that grants an exemption or relieves a restriction,

the 30-day delay of an effective date otherwise required by 5 U.S.C.

553(d) is inapplicable, and this designation is effective March 10,

1998.

4. The Current Rulemaking Proceeding

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 safety standard for bicycle

[[Page 11714]]

helmets. 59 FR 41,719 (August 15, 1994).

The Commission received 37 comments on that proposed bicycle helmet

standard from 30 individuals and organizations. After considering these

comments and other available information, the Commission proposed

certain revisions to the originally proposed standard. 60 FR 62662

(December 6, 1995).

In response to the second proposal, the Commission received 31

comments. These comments, and additional data that have been received

by the Commission since the second proposal, are discussed in Sections

C-E of this notice.

B. Overall Description of the Standard

The major features of the standard issued in this notice are

described below.

1. Impact Attenuation

The standard establishes a performance test to ensure that helmets

will adequately protect the head in a collision. This test involves

securing the helmet on a headform and dropping the helmet/headform

assembly to achieve specified velocities so that the helmet impacts a

fixed steel anvil. The helmet must provide protection at all points

above a line on the helmet that has a specified relation to the

headform.

Under the standard, the helmet is tested with three types of anvils

(flat, hemispherical, and ``curbstone,'' as shown in Figures 11, 12,

and 13 of the standard). These anvils represent shapes 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 (1-

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 the revised proposed standard, the

acceptable g value for children's helmets was reduced to 250 g and a

lower headform drop mass than that for adults was specified (3.90 kg).

As explained in section C of this notice, however, the final rule

specifies that the 5-kg headform mass and the 300-g peak acceleration

criterion will apply to all helmets subject to the standard, as

specified in the original proposal.

The standard provides that a helmet fails the performance test if a

failure can be induced under any combination of impact site, anvil

type, anvil impact order, or conditioning environment permissible under

the standard. Thus, the Commission will test for a ``worst case''

combination of test parameters. What constitutes a worst case may vary,

depending on the particular helmet involved.

2. Children's Helmets: Head Coverage

The standard specifies that helmets for small children (under age

5) must cover a larger portion of the head than must helmets for older

persons. A study by Biokinetics & Associates Ltd. found differences in

anthropometric characteristics between young children's heads and older

children's and adult's heads.9

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

\9\ Heh, S., Log of ASTM FO8.53 Headgear Subcommittee meeting

held May 21, 1992, date of entry June 17, 1992. Office of the

Secretary, U.S. Consumer Product Safety Commission, Washington, DC

20207.

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

3. Retention System

The standard requires that helmets be able to meet a test of the

dynamic strength of the retention system. This test ensures that the

chin strap is strong enough to prevent breakage or excessive elongation

of the strap that could allow a helmet to come off during an accident.

The test requires that the chin strap remain intact and not

elongate more than 30 mm (1.2 in) 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 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 standard requires certain labels on the

helmet. 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 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 standard also requires that helmets be accompanied by fitting

and positioning instructions, including a graphic representation of

proper positioning. As noted above, the 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.

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. Positional Stability (Roll Off)

The standard specifies 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.

The safety requirements discussed in paragraphs (1)-(6) above are

issued pursuant to the Bicycle Helmet Safety Act and are codified as

Subpart A of the Safety Standard for Bicycle Helmets.

7. Certification Labels and Testing Program

Under the authority of section 14(a) of the CPSA, the Commission is

also issuing certification testing and labeling requirements to ensure

that bicycle helmets meet the standard's safety requirements. These

certification requirements are in Subpart B of the Safety Standard for

Bicycle Helmets and are discussed in section D of this notice.

8. Recordkeeping

Under the authority of section 16(b) of the CPSA, the Commission is

issuing requirements that manufacturers (including importers) maintain

records of the required certification testing. These recordkeeping

requirements are found in Subpart C of the Safety

[[Page 11715]]

Standard for Bicycle Helmets and are discussed in section E of this

notice.

9. Interim Standards

The interim standards, which are currently codified as 16 CFR 1203,

will continue to apply to bicycle helmets manufactured from March 16,

1995, to March 11, 1999. Accordingly, the interim standards will

continue to be codified, as Subpart D of the standard. Also, Subparts

A-C of the standard are being added as an interim standard, so that

firms will have the option of marketing helmets meeting CPSC's final

standard before its effective date.

C. The Final Standard--Comments, Responses, and Other Changes

This section discusses comments on the second proposal, as well as

other issues that were dealt with in deciding the requirements of the

final rule. Numbers in brackets refer to the number assigned by the

Commission's Office of the Secretary to a comment on the second

proposal.

1. Accident Scenarios

Mr. Frank Sabatano [14], President of the London Bridge BMX

Association, recommended that bike helmets be constructed so as to

accommodate more serious accidents that might result from a child

bicycle racing or jumping rather than merely riding on a path or

street.

While no helmet can protect against every conceivable impact, the

available evidence supports the conclusion that helmets designed to

meet the CPSC standard will be very effective in protecting against

serious injury within a wide range of common bicycle riding conditions.

This would include many of the impact conditions that could occur

during racing or jumping. Furthermore, a standard for all bicycle

helmets has to balance the benefits of more protective helmets against

the additional cost, weight, bulk, and discomfort that more protection

may impose. Such undesirable qualities may discourage many users from

wearing helmets designed to protect against very severe impacts, which

could more than cancel the effects of the additional protective

qualities. Thus, the force with which the helmets are impacted in the

standard's performance test has not been increased.

2. Future Revisions

Randy Swart, Director of the Bicycle Helmet Safety Institute [16],

suggested that the following items be considered as future revisions to

the CPSC standard as progress in head protection research continues:

a. A test that requires the retention system to be easily adjusted

for good fit.

b. A test for protection against rotational injury.

c. A test to limit localized loads or ``point loading.''

d. A test for damage to the helmet by hair oil or other common

consumer preparations.

e. A test of the retention system after impact to simulate field

conditions.

f. A test to ensure that visors and mirrors are shatter-resistant

and easily peel off in a crash.

The Commission agrees that it is important to periodically review

research related to improvements in head protection to determine if

revisions should be considered for the CPSC bicycle helmet standard.

3. Compliance With Third-Party Standards as Compliance With the Rule

Jane McCormack [7] requested that the Commission ensure that bike

helmets meet the Snell requirements. Norte Vista Medical Center [15]

requested that helmets certified to the Snell B-95 or Snell N-94

standards be considered to be in compliance with the mandatory

standard.

The Commission declines to make these changes. One of the

objectives of the Bicycle Helmet Safety Act is to establish a unified

bicycle helmet standard that is recognized nationally by all

manufacturers and consumers. It would defeat Congress' intent to add

language to the regulation stating that certified conformance to any

existing voluntary standard satisfies compliance with the mandatory

rule.

4. Scope of the Standard

a. 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.'' The definition of bicycle helmet in the second

proposal included 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.

Bell Sports [12] suggested that the definition of bicycle helmet

should not include all products with a reasonably foreseeable use as a

device intended to provide protection from head injuries while riding a

bicycle. Bell maintains there are many helmets that have a foreseeable

use by bike riders that should not have to be certified to a bike

helmet standard (e.g., baseball and roller hockey helmets).

The respondent suggested that football helmets, baseball batting

helmets, and motorcycle helmets will also have ``easily foreseeable''

uses as bicycle helmets.

The Commission did not intend for the definition of bicycle helmet

to include football helmets, baseball batting helmets, and motorcycle

helmets that are not marketed for use while bicycling. It seems

unlikely that a helmet that is not marketed or promoted for bicycle use

will have a reasonably foreseeable use as a bicycle helmet. Thus, the

``reasonably foreseeable'' language is unnecessary. Therefore, in order

for the definition to provide more guidance, the ``reasonably

foreseeable'' language has been deleted, and the definition of bicycle

helmet has been changed to read: ``Bicycle helmet means any headgear

that either is specifically marketed as, or implied through marketing

or promotion to be, a device intended to provide protection from head

injuries while riding a bicycle.''

Helmets specifically marketed for exclusive use in a designated

activity such as skateboarding, rollerblading, baseball, roller hockey,

etc., would be excluded from this definition because the specific focus

of their marketing makes it unlikely that such helmets would be

purchased for other than their stated use. However, a multi-purpose

helmet--one marketed or represented as providing protection either

during general use or in a variety of specific activities other than

bicycling--would fall within the definition of bicycle helmet if a

reasonable consumer could conclude, based on the helmet's marketing or

representations, that bicycling is among the activities in which the

helmet is intended to be used.

In making this determination, the Commission will consider the

types of specific activities, if any, for which the helmet is marketed,

the similarity of the appearance, design, and construction of the

helmet to other helmets marketed or recognized as bicycle helmets, and

the presence, prominence, and clarity of any warnings, on the helmet or

its packaging or promotional materials, against the use of the helmet

as a bicycle helmet. The presence of warnings or disclaimers advising

against the use of a multi-purpose helmet during bicycling is a

relevant, but not necessarily controlling, factor in the determination

of whether a multi-purpose helmet is a bicycle helmet. A multi-purpose

helmet marketed without specific reference to the activities in which

the helmet is to be used will be presumed to be a bicycle helmet.

b. Multiple-Activity Helmets

Some commenters on the original proposal recommended that the CPSC

include provisions for children's bicycle helmets to provide protection

in

[[Page 11716]]

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 marketed 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.

The Commission did not propose that the standard address activities

other than bicycling, because the CPSC's authority under the Bicycle

Helmet Safety Act is to set mandatory requirements for bicycle helmets.

Establishing criteria for products other than bicycle helmets would

require the Commission to follow the procedures and make the findings

prescribed by the CPSA or the Federal Hazardous Substances Act

(``FHSA'').

The National Safe Kids Campaign (``NSKC'') [22] and the Consumer

Federation of America (``CFA'') [23] recognized that the scope of the

CPSC standard must be for bicycle helmets, but requested the Commission

to move forward in investigating the issues related to multi-activity

helmets. In a comment on the revised proposal, Mr. Frank Sabatano,

President of the London Bridge BMX Association [14], recommended that

bicycle helmets should serve as multi-purpose protective devices for

various sports such as bicycle riding, bicycle racing, skateboarding,

and in-line skating.

The Commission intends to monitor developments relevant to the

multi-activity issue. Wheeled recreational activities such as

traditional roller skating and in-line skating are typically conducted

on the same surfaces as bicycling, and can generate speeds similar to

bicycling. Therefore, it is reasonable to assume that helmets that meet

the requirements in the CPSC bike helmet standard will also provide

head protection for roller/in-line skating and perhaps some other

recreational activities. However, as discussed in the December 6, 1995,

Federal Register notice on the proposed rule, the Commission does not

have sufficient data on the benefits and costs of additional features

directed at injuries incurred in activities other than bicycling to

make the statutory findings that would be needed to issue a requirement

for such features under 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, the final standard only addresses

requirements for bicycle helmets. However, as discussed below, the

Commission will examine what actions it could take to encourage the use

of bicycle helmets in activities that present head injury risks similar

to those in bicycling.

NSKC [22] also urged the CPSC to work with community-based

organizations to develop a comprehensive educational campaign regarding

the importance of wearing a federally-approved bicycle helmet when

participating in non-motorized activities other than bicycling. The

Commission will consider what activities are appropriate in this regard

when setting its priorities for future activities.

5. Projections

Projections on the inner or outer surface of a helmet can

concentrate applied forces and cause injuries. Therefore, the revised

proposed standard provided that projections on the outer surface would

not exceed 7 mm (0.28 in) unless they break away or collapse on impact

and that projections on the helmet's interior not make contact with the

headform during testing.

NSKC [22] urged that the Commission prohibit any external

projections on helmets intended for children. NSKC believes that

external projections, such as visors, are unnecessary components of

helmets intended for children.

With regard to a possible hazard from external projections on

children's helmets, Sec. 1203.7 of the standard requires that helmets

must pass all tests, both with and without any attachments that may be

offered by the manufacturer. This provision, and the requirement that

any external projections shall break away or collapse, will address the

potential hazard of external projections on helmets intended for riders

of all ages. The proposed language is consistent with existing

voluntary standards, and no changes were made in response to this

comment.

SwRI [2] remarked that the proposed standard does not state how to

determine if an internal projection makes contact with the headform

during testing. NSKC [22] also suggested that instead of requiring

inner surface projections to not exceed 2 mm, the inside of the helmet

should contain no sharp edges or rigid internal projections.

After considering these comments, the Commission decided to revise

the section on internal projections to eliminate the requirement that

internal projections not make contact with the headform during testing,

while retaining the requirement that such projection not exceed 2 mm

(0.08 in). The purpose of this section is to prohibit potentially

hazardous projections but make some allowance for common helmet

construction practices. The language above is consistent with Snell

helmet standards, and the Commission is not aware of safety problems

associated with projections on helmets meeting existing standards.

6. Requirements for Qualities of Fitting Pads

NSKC [22] urged the Commission to include safety requirements for

fitting pads in the final standard. The commenter asserted that since

fitting pads are often necessary to ensure a secure fit, the standard

should address the integrity of the materials used to construct them,

as well as their thickness, durability, and adhesiveness.

CPSC staff has no information that long-term integrity of fitting

pads is a problem with helmets meeting existing standards. The interim

mandatory standards have no provisions of the type suggested by the

commenter. Introducing new requirements for fitting pads is not

essential at this time, and no change to the proposed standard has been

made in response to this comment.

7. Impact Attenuation Criteria

a. Extent of Protection

The originally proposed CPSC standard, and current U.S. voluntary

bicycle helmet standards, specified 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 test

line designates the lowest point on the helmet where the center of an

anvil may be aligned for testing. The second proposal specified a

single impact test line and no extent-of-protection boundary

requirement. 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 impact test line. Accordingly, the Commission deleted the extent-

of-protection boundary from the revised proposed standard.

In commenting on the latter proposal, Snell [28] discussed the

practical problems in certifying helmets when only an impact test line

is specified. Snell recommended that the standard be amended to require

coverage below the impact test line, particularly at the front and rear

of a helmet.

[[Page 11717]]

The Commission disagrees with this comment. Coverage does not imply

impact protection. The only area on the helmet required to pass impact

protection requirements is the area above the impact test line.

Therefore, it is unnecessary to specify additional coverage below the

test line.

The manufacturers of the Protective Headgear Manufacturing

Association (``PHMA'') [29] reported that they believed the proposed

CPSC standard requires coverage at the rear of the head lower than any

other standard. They stated that they are not aware of any studies

indicating that lower coverage at the rear is warranted. They also

stated their concern that the helmet-wearing public will not purchase

helmets that are perceived to be more ``clunky'' or ``bulbous,'' and

that helmets with extended coverage are likely be so perceived. Mr.

Becker of Snell [28] stated that the CPSC-proposed coverages are more

extensive than any current U.S. standard, except for Snell's B-95 and

N-94 helmet standards. He stated that unless the CPSC coverage is

changed, many contemporary helmet models that have protected their

wearers from life-threatening injury will disappear from the market.

Snell urged that the CPSC adopt the coverage described in the ASTM

F1447-94 or Snell B-90 standards. According to this commenter, these

coverages reflect the current state of the industry and should be

expected of every bicycle helmet.

The proposed CPSC impact test line is not lower at the rear of the

helmet than all other standards. The proposed CPSC impact test line is

somewhat lower at the rear of the helmet than the impact test lines in

the Snell B-90 and ASTM F1447 standards. However, the CPSC line is

higher at the rear of the helmet than the impact test lines in the

following interim mandatory standards: Snell B-95 and N-94, CAN/CSA-

D113.2, and ANSI Z90.4-1984.

CPSC is aware of two studies that show that it is not uncommon for

helmets involved in accidents to suffer impacts at the rear portion of

the helmet. A Bell Sports study of 1100 helmets involved in accidents

found that 26% of the impacts were at the rear of the helmet and that

the majority of these rear impacts occurred within 50 mm of the bottom

edge of the helmet.10 Another study, by Technisearch of

Australia, examined the effect of lowering the impact test line from

the Snell B-90 standard to the impact test lines in the Snell B-95 and

N-94 standards.11 The Technisearch study was based on

examinations of 104 bicycle helmets whose wearers sustained impacts to

the head during accidents. The study concluded that the B-90 standard

test line would have provided coverage for 51% of the impacts. The

impact test line of the B-95 standard would provide coverage for 65% of

the impacts. The increase from 51% to 65% was represented by 20

additional impact sites that would fall within the area of the B-95

coverage, including 8 impact sites at the rear portion of the helmet.

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

\10\ Dean Fisher and Terry Stern, ``Helmets Work!,'' Bell

Sports, Inc., AAAM/IRCOBI Conference, Lyon, France (September 1994).

\11\ Martin Williams, ``Test Line Requirements and Snell B-95

and N-94 Standards,'' Technisearch Engineering & Scientific Services

(August 1994).

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

One of the directions of the Children's Bicycle Helmet Safety Act

is to include provisions from existing appropriate standards for

adoption in the final CPSC standard. The CPSC impact test line is a

reasonable requirement that will improve the protective characteristics

of helmets overall, while falling within test lines of established

North American bicycle helmet standards.

b. Distance Between Impacts

A commenter on the original proposal recommended revising the

minimum distance between impact sites from the originally proposed

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

believed 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 adopted this recommendation in the revised

proposal.

Two commenters on the revised proposal [27 and 29] recommended a

minimum distance between impacts of 150 mm, or about 6 inches. One of

these commenters stated that the CPSC made the minimum distance shorter

than those in voluntary standards.

The Commission selected the 120-mm impact spacing based on recently

balloted ASTM headgear standards. The Snell B-95 standard also

specifies a minimum impact separation of 120 mm. This distance is

consistent with the Snell B-90 specification of \1/6\th the maximum

helmet circumference, if calculated for smaller helmets. A minimum

impact spacing of 150 mm would limit flexibility in choosing impact

sites, especially on smaller helmets. Therefore, no change to the

proposed rule was made in response to this comment.

c. Impact Velocity Tolerance

The University of Southern California's Head Protection Research

Lab (``USC-HPRL'') [8] suggested that the tolerance for the impact

velocity be changed from 3% to -0% to +5% to ensure that

impact testing is done at no less than the specified velocity.

The difference between tolerances of 3% and -0%, +5%

has little practical significance for a 300-g criterion. Since the

commenter's suggestion would not produce a significant safety benefit,

the Commission made no change to the proposed rule in this regard.

d. Other Requirements for Children's Helmets: Peak-G Value and Drop

Mass

One of the provisions of The Children's Bicycle Helmet Safety Act

of 1994 is that the Commission include in the final CPSC standard

provisions that address the risk of injury to children. This does not

require that children's helmets be subject to requirements that differ

from those for adults' helmets; it requires only that the final

standard be appropriate for children's helmets. The issue of whether

special standard provisions for young children's helmets are needed has

been debated for several years by head protection experts.

A young child's skull has different mechanical properties than the

skull of an older child or adult. These differences are especially

evident for children under the age of 5 years. Their skulls have a

lower degree of calcification, making them more flexible than adult

skulls. During an impact to the head, the increased skull flexibility

results in a greater transfer of kinetic energy from the impact site to

the brain tissue. Besides the different mechanical properties, the mass

of a young child's head is also different from that of a more mature

person's head. Studies show that the head mass of children under the

age of 5 years ranges from approximately 2.8 to 3.9 kg. This mass is

lower than the 5-kg test headform mass specified in current U.S.

bicycle helmet standards.

The Commission first proposed a safety standard for bicycle helmets

on August 15, 1994. In that proposal, the only special provision for

helmets for children under 5 years was an increased area of head

coverage. On December 6, 1995, however, the Commission proposed special

provisions for headform mass, peak-g limit, and head coverage for

bicycle helmets for children under 5 years. The special children's

provisions were based on the ongoing work of voluntary standards

organizations and proposals at that time in the technical literature.

The following comparison shows the CPSC-proposed

[[Page 11718]]

test parameters for helmets for children under 5 years and for helmets

for older persons.

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

Under 5 5 and older

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

Mass of test headform............. 3.9 kg............... 5.0 kg

Peak-g limit...................... 250-g................ 300-g

Head coverage..................... More coverage at rear

and sides of head.

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

The proposal for increased head coverage of children's helmets is

relatively uncontroversial, and the final rule contains this

requirement. However, the Commission has reassessed the proposed

headform mass and peak-g requirements. The Commission's conclusions are

discussed in detail below.

A few respondents to the proposed rule [8, 16] supported the lower

mass and lower peak-g provisions, believing that they will lead to an

improvement in head protection for small children. One of these

respondents, however, urged the Commission to consider the most recent

research on this subject before including the special provisions in a

final standard. One respondent [12] favored a reduced headform mass

provision, but did not recommend a reduced peak-g provision, stating

that it could result in a helmet with a lower margin of safety.

Several respondents [3, 4, 6, 9, 10, 13, 15, 18, 19, 27, 28, 29,

30] questioned whether it is advisable to move forward with the

provisions of a reduced-mass headform and a lower limit for peak

acceleration. Some respondents suggested that special children's

provisions should not be adopted since studies show that children's

helmets as they exist today provide excellent protection.

Studies by researchers at the Harborview Injury Prevention and

Research Center have shown that bicycle helmets that meet existing

standards are effective in protecting against serious head and brain

injuries.12 One of the items analyzed in the most recent

Harborview study was whether the protective effects of bicycle helmets

vary by the age of the user. For four age groups of riders, they

estimated the protective effect of helmets against three levels of

injury listed in order of increasing severity: (1) head injury, (2)

brain injury, and (3) severe brain injury.

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

\12\ Thompson, Robert S., MD; Rivara, Frederick P, MD, MPH; and

Thompson, Diane C., MS ``A Case Control Study of the Effectiveness

of Bicycle Safety Helmets,'' The New England Journal of Medicine 320

[May 1989]: 1361-1367. Thompson, Diane C., MS; Rivara, Frederick P,

MD, MPH; and Thompson, Robert S., MD. ``Effectiveness of Bicycle

Safety Helmets in Preventing Head Injuries,'' Journal of the

American Medical Association 276 (December 1996): 1968-1973.

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

Due to the small number of helmeted case subjects that suffered

brain injury and severe brain injury, Harborview researchers could not

estimate the protective effect of helmets against these injuries for

the under 6-year-old age group. Accordingly, the Commission has not

relied on this study in its consideration of whether special

requirements are needed for children's helmets. However, one of

Harborview's overall conclusions was that helmets are effective for all

bicyclists, regardless of age, and that there is no evidence that

children younger than 6 years need a different type of helmet.

The Commission requested technical views on this issue from Barry

Myers, M.D., Ph.D. Associate Professor, Department of Biomedical

Engineering, Duke University. In his report,13 Dr. Myers

explains that such modifications of the standard should be considered

only if it can be shown to improve the protective qualities of helmets.

Improvements may be shown by epidemiological or biomechanical evidence.

However, considering the degree of head injury protection provided by

current helmets, incremental improvement would be difficult to detect,

even with a large epidemiological study.

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

\13\ Myers, Barry, M.D., Ph.D. ``An Evaluation of A Helmet

Standard for Children,'' Report to the U.S. Consumer Product Safety

Commission (July 1997).

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

From a biomechanical perspective, it is important to assess how

changes in test headform mass and peak-g criteria would affect helmet

design and protective capability. This can be done by examining how a

helmet functions to protect the head in an impact.

The helmet has a crushable liner typically made of expanded

polystyrene foam. If the liner is crushed as the head presses against

the inside of the helmet during impact, the liner allows the head to

stop over a longer distance and time than would otherwise be the case.

This reduces the transfer of energy to the head, thereby reducing the

risk of injury.

The degree to which the liner resists being crushed also affects

the helmet's protective qualities. For a given impact, a helmet liner

that is too soft will ``bottom out,'' thereby losing its protective

ability to allow relative movement between the head and the object

being impacted. Conversely, a liner that is too hard will not allow

sufficient crushing to adequately protect the head.

Proponents of special provisions for young children's helmets

believe that these helmets should be tested under different test

parameters than helmets intended for older persons. The current test

parameters are based primarily on adult head injury tolerance and on a

headform mass that is approximately that of an adult head. Supporters

of special provisions contend that these adult test parameters result

in a helmet with a liner that is too stiff to optimally protect a young

child's head. By using a headform weight that better represents a young

child's head (e.g., 3.9 kg), and reducing the allowable peak-g, helmets

would need to be designed with a lower density (``less stiff'') liner

to further lessen the impact transmitted to the head.

A simple way to examine the effect of changing headform mass and

the peak-g criterion is to model the helmet as a spring and apply the

one-dimensional spring-mass impact formulas shown below. This approach

is discussed by both Dr. Myers and by Mr. Jim Sundahl, Senior Engineer

with Bell Sports, in his response to the proposed rule [12].

[GRAPHIC] [TIFF OMITTED] TR10MR98.000

Where:

apeak = peak acceleration (peak-g)

Vo = impact velocity

k = liner stiffness

m = headform mass

xpeak = required stopping distance (liner thickness)

If the value for headform mass m is reduced in Equation (1), the

value for liner stiffness k must be reduced to achieve the same peak-g

at the same impact velocity. This means that if a helmet that meets the

standard's criteria with a 5-kg headform did not meet the peak-g

requirement using a lighter headform, the helmet liner would need to be

made softer so more crushing of the liner could occur.

If the value for peak acceleration apeak is reduced in

Equation (1), and the other variables are held constant, the value for

liner stiffness k again must be reduced. Thus, a helmet that could not

comply with a reduced peak-g criterion also would need a softer liner

to allow more crushing. Equation (2) shows that, with a decreased liner

stiffness, a greater percentage of the available crush distance will be

used during impact.

The biomechanical analysis shows that, for impact conditions that

do not result in complete compression of the

[[Page 11719]]

helmet's liner, it is possible to lessen the impact energy transmitted

to the head (and reduce the risk of injury) by reducing the stiffness

of the liner. However as the impact energy increases, a helmet with a

softer liner will bottom out (crush beyond its protective capacity)

under less severe conditions than a helmet with a more rigid liner of

the same thickness. To compensate, the softer helmet would have to be

made thicker to prevent bottoming out. However, there is a limit to how

thick a helmet can be before it is no longer practical or appealing to

the user. Therefore, the goal of helmet design is to optimize liner

density and thickness to protect against the widest range of impact

conditions and still have a product people will use.

The biomechanical analysis suggests that reducing the liner

stiffness could have both a positive and a negative influence on the

protection provided by helmets under existing criteria. Therefore, it

is necessary to also examine available epidemiological data that relate

to this issue. Decreasing the liner stiffness would benefit those who

experience injuries with minimal or no liner deformation of current

helmets. However, a decrease in liner stiffness could increase the

number of head injuries that occur during more severe impacts that

cause the helmet liner to bottom out.

To learn the effect on the level of protection offered by softer

helmet liners for children under 5, two questions would need to be

answered:

1. Are children suffering head injuries with minimal or no

deformation of current helmet liners?

2. Are children suffering head injuries with a bottomed-out liner?

Unfortunately, currently available information does not answer

either of these questions. Therefore, it is uncertain whether young

children would benefit from special provisions for headform mass and

peak-g.

The only known study to examine the relationship between helmet

damage and head injury was completed in 1996 by the Snell Memorial

Foundation and the Harborview Injury Prevention and Research

Center.14 Of those bicycle helmets collected from

individuals (of various ages) who went to a hospital, 40% of the

helmets had no deformation, 14% had significant damage in which the

helmet was approaching a bottomed-out condition, and 7% of the helmets

had catastrophic damage. The data were not presented specifically for

the under-5 age group or any other specific age group. The study showed

that there was a risk of head and brain injury even with no or minimal

helmet damage. The risk of injury increased moderately as the severity

of helmet damage increased, until catastrophic damage was reached. As

expected, the risk of head and brain injury jumped dramatically when a

helmet was damaged catastrophically. This study suggests that if

helmets for all ages were designed with softer liners, there is a

potential to both improve the protection for lower-severity impacts and

increase the risk of injury at the higher-severity impacts.

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

\14\ Rivara, Frederick P., MD, MPH, Thompson, Diane C., MS,

Thompson, Robert S., MD ``Circumstances and Severity of Bicycle

Injuries,'' Snell Memorial Foundation/Harborview Injury Prevention

and Research Center (1996).

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

Since the risk of injury rises dramatically with catastrophic

helmet damage, and current helmets are effective in reducing the risk

of head and brain injuries, it would be imprudent to require softer

helmet liners for bicyclists of all ages. The available data are

insufficient to determine that such a change would increase overall

protection. When focusing on the age range of under 5 years, currently

available information is even more sparse. Therefore, if helmets for

children under age 5 were made with softer liners, there are

insufficient data to estimate either (1) the level of protection that

might be gained at the lower-severity impacts or (2) the protection

that might be lost at the severe impact conditions that completely

crush the liner.

For the reasons discussed above, the Commission did not include

special provisions in the final standard for headform mass and peak-g

criteria for young children's helmets. There are insufficient data to

justify the changes, and these changes could provide less protection in

the most serious impacts. However, should future studies provide

evidence that young children, or bicyclists of any age, could benefit

from decreased liner stiffness, the Commission could consider revisions

to the bicycle helmet standard at that time.

8. Impact Attenuation Test Rig

a. Type of Test Rig

The originally proposed CPSC standard and the current interim

mandatory standards allowed the use of either a wire- or rail-guided

impact test rig. In the revised proposal, the Commission specified only

the monorail test rig, to avoid the possibility that different results

would be obtained with the two types of test rigs.

Some helmet manufacturers [5, 29, 30], and the Snell Memorial

Foundation [28], disagreed with the specification of the monorail type

of impact test rig. Commenters stated that guidewire rigs were more

widely used in the industry. Some commenters claimed that since there

is no evidence that directly correlates monorail with guidewire rig

results, many firms would be forced to buy monorail rigs to address

liability concerns. Trek [5] stated that the burden of this expense may

require additional analysis of the financial impact to small business,

as required by the Regulatory Flexibility Act. Snell wrote that

guidewire rigs have proven reliable, efficient, and highly repeatable.

They are less expensive to install than monorail devices, and they are

easier to maintain. Snell stated that there is no demonstrated

improvement associated with the monorail rig in testing reliability and

capability. Most commenters suggested that the Commission allow both

monorail and guidewire rigs.

To respond to this issue, the CPSC's staff initiated a seven-

laboratory comparison test program. The main purpose of the study was

to determine if there are statistically significant mean differences in

test results when using monorail and guidewire test rigs under

standardized testing conditions.

Seven laboratories participated in the test program, including the

CPSC lab. Five of the laboratories tested on both monorail and

guidewire rigs. Two laboratories only tested on monorail rigs. Three

different helmet models were used. Each helmet was impacted twice, once

at the rear of the helmet and once near the crown. Tests were conducted

using flat and curbstone anvils, and all testing was performed with

ambient-conditioned helmets. This experiment allowed the analysis of

the effect of the following variables: rig type, anvil type, helmet

model, laboratory, anvil impact sequence, and impact location.

The statistical analysis of the interlaboratory results showed that

for the majority of variable combinations, the choice of test rig did

not have an appreciable effect on test results. However, on the Model I

helmets, and only when the second impact was on the curbstone anvil,

the monorail showed a significantly higher mean logarithm for peak-g

readings summed across laboratories having both types of test rigs. For

reasons completely unrelated to these test results, a curbstone impact

in combination with another impact on any single test helmet is no

longer permitted in the final standard. Since the interlaboratory data

(summed across the laboratories that used both types of test rigs) show

no significant differences between guidewire and monorail rigs under

test conditions within those allowed in the

[[Page 11720]]

final standard, the standard allows either type of rig to be used for

impact attenuation testing.

Over the last 15-20 years, voluntary standards in the U.S. have

allowed both monorail and guidewire types of test rigs. Both types of

test rigs have been used extensively in independent test laboratories

and in manufacturers' in-house test facilities. The Snell Memorial

Foundation, one of the established helmet test organizations in the

U.S., uses guidewire rigs to test conformance to their standards. The

Commission has no evidence that the allowance of both types of test

rigs in voluntary standards has resulted in a compromise of safety for

bicycle helmet users.

For the reasons discussed above, the Commission concludes that both

types of rigs are suitable for impact attenuation testing. Therefore,

the final CPSC standard specifies that either a monorail or a guidewire

test rig may be used.

b. Accuracy Check

After evaluating the results of the multi-lab testing, the

Commission concluded that the instrument system check procedure should

include a procedure for calibrating the accuracy of a test rig.

Therefore, the final rule includes a precision and accuracy procedure,

so that laboratories can verify that their test equipment is recording

accurately. The procedure requires that an aluminum sphere (spherical

impactor) of a specified dimension be dropped with a certain impact

velocity onto a Modular Elastomer Programmer (MEP). A MEP is a

cylindrical pad of polyurethane rubber that is used as a consistent

impact medium for the systems check procedure. Pre-test and post-test

impacts on an MEP to verify system recording is a standard practice of

bicycle helmet test labs. All recorded impacts must fall within the

range of 380 g to 425 g. In addition, the difference between the high

and low values of the three recorded impacts must not be greater than

20 g.

The range of 380 g to 425 g represents an allowable tolerance of

about 10%. The interlaboratory testing showed this tolerance to be

attainable between laboratories. However, test experience shows that

even greater precision can be obtained for the systems check procedure

within a given laboratory. The test data from the interlaboratory study

show that a target range of 380 g to 425 g and a precision range of 20

g can be achieved.

c. Test Headform Characteristics

SwRI [#2] suggested that a more appropriate value for the lower

limit on the resonant frequency of the headform material should be 2000

hz instead of 3000 hz.

The important conditions for the test headforms are the material

specification and the dimensions defined by the draft ISO/DIS 6220-1983

standard.\15\ This goal is accomplished by stating that the headforms

shall be rigid and be constructed of K-1A magnesium alloy. Test

experience shows that headforms meeting this description will not

exhibit resonant frequencies that will interfere with proper data

collection. Therefore, Sec. 1203.9 has been changed to delete reference

to any lower limit on resonance frequencies. The proposal also stated

that another ``functionally equivalent'' metal could be used as the

headform material. This alternative has been eliminated in the final

rule to specify the headform apparatus as precisely as possible and

ensure against the use of materials that may influence the test

results.

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

\15\ Although the draft ISO/DIS 6220-1983 standard was never

adopted as an international standard, it has become a consensus

national standard because all recent major voluntary standards used

in the United States for testing bicycle helmets establish their

headform dimensions by referring to the draft ISO standard.

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

Dr. Richard Snyder, President of the George Snively Research

Foundation [19], referenced two studies that related helmet fit to head

size and shape. The first study was conducted by Dr. Bruce Bradtmiller

of the Anthropometry Research Project, Inc. Dr. Bradtmiller also

responded to the proposed rule [20]. He concluded that, for proper

child-helmet sizing, head breadth and length variables were more

accurate guides than using age or head circumference. Dr. Bradtmiller

urges caution in basing the CPSC's rules for children's helmets on the

draft ISO DIS 6220-1983 standard for test headforms. The study shows

variation in the ratio of head length to head breadth. This ratio was

found to be the prime determinant for helmet fit. The ISO standard,

however, maintains a constant head breadth/length ratio. A second study

also concluded that head circumference was not always a good indicator

for helmet fit.

ISO headforms are the established norm for headgear testing in the

U.S., Canada, Europe, and Australia. No other system of headforms is

currently available that can be shown to prevent more injuries.

Therefore, the Commission is retaining the ISO headform specification

in the final CPSC standard. However, the Commission's staff will stay

current on developments of test procedures and equipment that could

lead to improvements in general helmet fit and in improvements that

make it easier to fit and adjust helmets, especially for children.

d. Alignment of Anvils

The Commission amended Sec. 1203.17(a) to specify that the center

of the anvil must be aligned with the center vertical axis of the

accelerometer. This describes the already standard operating procedure

for bicycle helmet testing and is meant to prevent impacting helmets on

the ``corners'' of anvils.

e. Definition of ``Spherical Impactor''

SwRI [2] suggested that it is more important to specify a 5-kg

combined drop mass for the spherical impactor and the drop assembly

than to specify a 4-kg mass for the impactor itself.

The Commission has adopted this suggestion. The more precise

specifications for a spherical impactor for use as a system check

device are now in Sec. 1203.17(b)(1), under the systems check

procedure.

9. Impact Attenuation Test Procedure

a. Anvil Test Schedule and Use of Curbstone Anvil

Six respondents [5, 12, 27, 29, 30, and 31] submitted comments

requesting changes to the test schedule in Sec. 1203.13 regarding the

use of the curbstone anvil. All of the respondents expressed concern

over using two curbstone impacts on a single helmet. As proposed,

Sec. 1203.3(d) and Table 1203.13 did not define the conditions of the

fourth impact on a helmet. The fourth impact in the proposed standard

was left to the discretion of test personnel, and thus could have been

a second curbstone impact. One of the commenters was also concerned

about impacting the helmet with the curbstone anvil after the helmet

was conditioned in a wet environment [12].

There also was concern about the curbstone footprint overlapping

other impact sites and violating the ``single impact'' principle of

testing [27 and 31]. The length of the curbstone anvil restricts the

location of impact sites that can be used without overlap. The use of a

second curbstone anvil, and the damage caused by curbstone impacts, can

restrict the selection of test sites further, to the point where only

three impacts without overlap may be possible on a small helmet.

The Commission agrees that the previously proposed test schedule

[[Page 11721]]

should be revised to prevent the possibility of striking a test helmet

with more than one curbstone impact. The potential for overlapping

``footprints'' of curbstone impacts combined with other impacts on a

single test helmet goes beyond the intended principle of a single

impact for a given area. The Commission disagrees, however, with those

commenters who recommended that only ambient-conditioned helmets be

subjected to a curbstone impact. To ensure adequate protection against

impact against curbstone-type shapes, tests for that anvil, as well as

the other test anvils, should be carried out in all of the

environmental conditions prescribed by the standard. Accordingly,

revised Sec. 1203.13 and Table 1203.13 contain a revised test schedule

to incorporate a single curbstone impact on each of four ``clean''

helmet samples, one from each of the conditioning environments.

The Commission's staff discovered during testing with the curbstone

anvil that severe physical damage--namely splitting of the helmet from

the impact point to the edge of the helmet--could occur even though the

impact did not exceed the 300 g criterion. This led to consideration of

whether in such cases the curbstone anvil test should be repeated on

another sample to help ensure that other helmets will not fail this

test.

The Commission acknowledges that, when marginal or unusual results

occur in any of the standard's tests, retesting may be appropriate,

even though the 300-g criterion is not exceeded. Other conditions that

may prompt the Commission to undertake verification testing include

(but are not limited to) peak-g readings that are very close to the

300-g failure criterion. However, since the option of additional

testing inherently exists, it is not necessary to include a provision

requiring such retesting in the standard.

b. Definition of ``Comfort Padding''

The proposed definition of comfort padding included the statement:

``This padding has no significant effect on impact attenuation.'' SwRI

[2] commented that fit padding may have some influence on impact

characteristics.

The Commission agrees with this commenter and deleted this

statement from the definition.

c. Testing on More Than One Headform

In the revised proposal, the standard would have tested a helmet on

all sizes of headform on which it fit. ``Fit'' was obtained if it was

not difficult to put the helmet on the headform and the helmet's

comfort or fit padding was partially compressed.

PHMA [29] recommended that the situation where more than one

headform will ``fit'' a helmet should be addressed by specifying the

use of the largest headform that will accommodate the helmet, with

comfort padding adjusted to optimize the fit.

The Commission concludes that it is appropriate to simplify the

test procedure by testing on only one size headform. This is consistent

with the current interim mandatory standards. However, in contrast to

the commenter, the Commission believes that it is more appropriate to

test on the smallest headform that is appropriate for the test sample.

The Commission believes that the smaller headform will represent the

more stringent test condition for the positional stability test.

Testing on only one size headform will lessen the number of test

samples needed to test compliance to the standard.

Therefore, a helmet shall be tested on the smallest of the

headforms appropriate for the helmet sample. This size headform is the

smallest headform on which all of the helmet's sizing pads are

partially compressed when the helmet is equipped with its thickest

sizing pads and positioned correctly on the reference headform.

Bell Sports [12] remarked that, where a helmet will ``fit'' more

than one headform size, choosing the conditioning environment for

testing on the larger headform(s) that produced the highest g-value in

the test on the smallest headform that the helmet fits does not

necessarily provide the worst case. The commenter recommended that

there be four impacts in any conditioning environment chosen by the

test technician. As explained above, the Commission is not going to

test a given size helmet on more than one headform size. Accordingly,

this comment is no longer applicable.

d. Number of Helmets Required for Testing

Four respondents commented on the number of helmets required for

testing when the helmet includes attachments, (e.g., removable visor,

face shield) and possible combinations of attachments [5, 12, 29, and

30]. They expressed concern that the proposed standard requires too

many production helmet samples to be tested. One respondent [12]

offered suggested amending Sec. 1203.7(b) to include the statement that

``Helmets can be tested with any combination of accessories.''

Section 1203.7(a) of the proposed standard requires helmets to be

``tested in the condition in which they are offered for sale.''

Additionally, they are required to pass all tests both with and without

any attachments that may be offered. To adopt the suggested wording

would not maintain the requirement that helmets would meet the standard

with all combinations of accessories. However, the Commission agrees

with these commenters that it may be impractical and unnecessary to

specify an additional set of eight test helmets for each added

attachment and each combination of attachments in order to test for

compliance with the standard.

To address this issue, the Commission decided to specify that

attachments need be tested only when they can affect the test results,

and that even then only a ``worst case'' combination of attachments

need be tested. See the changes to Sec. 1203.7(b) and

Sec. 1203.12(d)(1). For example, in the case of a removable visor that

has no influence on the retention system strength test, it would be

unnecessary to test four helmets (one for each conditioning

environment) to that test with the visor attached and an additional

four helmets without the visor. However, it may be possible for

attachments such as visors or faceshields to influence tests such as

impact attenuation or peripheral vision.

10. Helmet Conditioning

a. Low-Temperature Environment: Temperature Range

SwRI [#2] commented that the allowable temperature range in the

low-temperature environment should parallel the allowable temperature

ranges in the other environments.

The Commission believes it is more important for the low-

temperature environment range to be consistent with the current interim

standards than for the range to parallel the tolerance allowed in the

other environments. Thus, this comment was not adopted. However, the

proposed temperature range contained a typographical error. The range

should have been (-17 to -13 deg.C). This range is consistent with

ANSI, ASTM, Snell 95 and CSA standards. This typographical error has

been corrected.

b. Water-Immersion Environment

Paula Romeo [26] suggested that the water-immersion environment was

unrealistic and recommended a spray conditioning environment.

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

[[Page 11722]]

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

conditioning exposure. Since testing showed that these commenters'

concerns were unfounded, the immersion method of wet-conditioning is

retained.

c. Reconditioning Time

The revised proposed standard provided that a helmet that was

removed from its conditioning environment for more than 3 minutes

before testing would be reconditioned for 5 minutes for each minute

beyond the allotted 3 minutes before testing could be resumed. SwRI [2]

noted that there would be potentially no upper limit to the exposure

time to recondition a helmet once it is removed from the conditioning

environment for more than 3 minutes.

The Commission agrees with this comment and has added a 4-hour

limit to the reconditioning time in Sec. 1203.13(c).

11. Labels

a. Label Format and Content

Two respondents [22, 23] urged the Commission to require ``an

appropriate symbol to appear adjacent to the statement of compliance on

the label'' and to add wording to warn that ``failure to follow the

warnings may result in serious injury or death.''

The Commission agrees that more emphasis should be placed on the

warning labels. Accordingly, the signal word ``WARNING'' is used with

the warnings required by Sec. 1203.6(a)(2)-(5). See Sec. 1203.6(a)(6).

The Commission concludes that the signal word will be more effective

than a symbol, and the limited size of the inside of a helmet, and the

amount of information already required on the labels, prevents the use

of both a signal word and a symbol.

The limited space also prevents using the additional suggested

language ``failure to follow the warnings may result in serious injury

or death.'' In addition, this language could possibly mislead some to

conclude that proper use of a helmet will always prevent serious injury

or death. Accordingly, the Commission is not requiring a warning symbol

or the suggested language that ``failure to follow the warnings may

result in serious injury or death.''

b. Use Label

The proposed standard required a label stating ``Not for Motor

Vehicle Use.'' Some comments addressed this choice of language.

[Comments 11, 13, 22, 26.]

Two commenters stated that ``Not for Motor Vehicle Use'' wrongly

suggested the helmet was appropriate for any use other than motor

vehicles. Another commenter felt that ``Not for Motor Vehicle Use''

allows the helmet to be used for other activities similar to bicycle

riding, where no alternative helmet exists. A fourth commenter argued

that ``For Bicycle Use Only'' was a positive statement to which users

are more likely to respond.

On reconsideration, the Commission concludes that neither the ``Not

for Motor Vehicle Use'' label nor the ``For Bicycle Use Only'' label

adequately conveys the circumstances under which helmets that meet the

CPSC standard are appropriate. It is reasonable to assume that helmets

that are certified to the CPSC standard will also provide head

protection for roller skaters, in-line skaters, and, perhaps, some

other recreational activities. In-line skaters should not be

discouraged from wearing a helmet by a label stating ``For Bicycle Use

Only.''

The Commission also believes that consumers understand both the

differences between bicycle helmets and motorcycle/motorsport helmets

and that bicycle helmets would not provide adequate protection for

motorsport activities. Therefore, the ``Not for Motor Vehicle Use''

label is not a critical safety message that should be mandated in the

CPSC standard. Therefore, the final CPSC standard does not require a

``use'' label, but maintains the requirement for a certification label

that informs the consumer that the helmet is certified to the U.S. CPSC

standard for bicycle helmets.

c. Labeling for Cleaning Products

The second proposal required a label warning the user that the

helmet can be damaged by contact with common substances (such as

certain solvents, cleaners, etc.) and that this damage may not be

visible to the user. This label is also required to 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.

Several respondents [2, 11, 12, 29] expressed concern that too much

information about cleaning products would be needed on the label and

argued that consumers should be directed to the instruction manual for

the list of cleaning materials.

This label is not intended to list every possible cleaning agent

that can or should not be used on the helmet. Since the consumer may

not always have the owner's manual, a label on the helmet should

provide some general cleaning instructions and warnings. The language

of Sec. 1203.6(a)(5) has been changed to make this intent clear.

d. Warning To Replace After Impact

[Commenters 22, 23, 26.] Some respondents agreed with the proposed

standard's provision that the label on the helmet should advise

consumers to destroy the helmet or return it to the manufacturer if it

is involved in an impact. Others disagreed and requested more guidance

on whether the helmet is impaired before a consumer has to return the

helmet.

The variety of factors (impact surface, impact location on helmet,

impact speed, etc.) that are involved in an impact to a helmet, and the

level of interaction of each factor, are so complex that it is

inappropriate to address them in a label. It is to the consumer's

overall safety benefit to return the helmet to the manufacturer or

destroy and replace it. Accordingly, the proposed replacement warning

is not changed.

e. Durability of Labels

SwRI [2] remarked that a requirement for labels to be likely to

remain legible throughout the life of the helmet cannot be tested and

could lead to differences between laboratories. The PHMA [29] also

expressed concern about this requirement, stating that it was unaware

of any technology that will ensure that a sticker will stand up under 5

years of the type of exposure that a helmet receives.

The Commission shares these commenters' concerns. Current voluntary

bicycle helmet standards require ``durable'' labeling or labeling that

is ``likely to remain legible for the life of the helmet.'' These

conditions are not quantified in current standards. The Commission is

not aware of any existing performance test method that can be applied

in this circumstance. Since a requirement for legibility for the life

of the helmet is vague and possibly unattainable, the Commission has

changed the requirement to require ``durable'' labels.

f. Labels on Both Helmets and Boxes

The American Society of Safety Engineers (``ASSE'') [11] and the

NSKC [22] suggested that ``proper fit'' information should be on both

the helmet and the outside of the box.

The Commission does not believe it is necessary to have the actual

fitting instructions on the box, because there is no information

indicating that such a label would be effective in assuring proper fit.

However, it is important that consumers be aware that helmets do come

in different sizes and that proper

[[Page 11723]]

fit is important. A label on the box promoting the need for proper fit

could inform parents, before they buy the helmet, that they need to

properly fit the helmet to the child. Therefore, the final standard

applies Sec. 1203.6(a)(3) to the helmet's packaging, as well as to the

helmet.

12. Instructions for Fitting Children's Helmets

The NSKC [22] recommended that the proposed fitting instructions to

accompany children's helmets be in age-specific language.

The Commission believes that age-specific instructions are

unnecessary. The proposed standard requires both a graphic

representation of proper positioning and written positioning and

fitting directions. The graphics will reach more children than would

age-specific instructions, because they allow children of all ages to

compare the way their helmet looks with the pictures. In addition,

graphics convey the critical information to non-English-reading

individuals and illiterates. Children and adults are likely to be

better able to understand and appreciate pictures than age-specific

instructions. This is more likely to effectively deliver the message,

allowing both parents and children to become aware of the proper fit.

13. Retention System Strength Test

SwRI [2] asked whether both the peak and residual displacements in

the test of the dynamic strength of the retention system should be

measured in order to better describe the dynamics of the system.

Only the peak deflection reading is needed to determine failure of

the retention system. This is consistent with existing U.S. bicycle

helmet standards. Therefore, no change to the proposed rule was made in

response to this comment.

USC-HPRL [8] suggested that the retention system test

(Sec. 1203.13(d)) be done after impact testing. The commenter reasons

that an accident can damage a helmet and severely compromise the

retention system. The retention system must ensure that the helmet

remain on the head during an accident sequence.

After considering this comment, the Commission decided to make no

changes to the sequence for retention system testing. Testing the

retention system prior to impact testing is consistent with the ASTM

and Snell standards. The Commission has no evidence that the test

sequence in the ASTM and Snell standards allows helmets that do not

have adequate retention systems.

The commenter also recommends that the ``zero'' position for

measuring elongation be established without the proposed step of pre-

tensioning the straps with a 4-kg mass.

There is no evidence that establishing the ``zero'' position after

pretensioning the retention system, as proposed, would allow helmets

that do not have adequate retention systems to pass the test.

Therefore, the Commission made no changes to the procedure for

establishing the pre-test ``zero'' position.

14. Positional Stability Test

SwRI [2] remarked that the ASTM Headgear Subcommittee is

considering a 7-kg preload to set the helmet during testing. SwRI also

asked whether a thin rubber pad should be specified to soften high

frequency impact noise.

Testing to support the development of the positional stability test

was with equipment specified as proposed in the CPSC standard.

Subsequent to initial ASTM discussions about possible revisions to the

proposed test procedure, the ASTM F8 Headgear Subcommittee decided not

to modify the pre-load and not to specify a rubber impact pad.

Therefore, the Commission made no change to this section.

NSKC [22] also recommends that the Commission examine the potential

influence that fitting pads may have on the helmet's ability to comply

with the retention system requirements.

When testing for positional stability, the standard instructs

testers to position and fit the helmet on the test headform according

to the manufacturer's instructions. This procedure may involve changing

the size and position of the fit pads in order to achieve a secure fit.

A similar procedure is followed to fit a bicycle helmet to the user.

Although fitting a helmet to a metal headform will not account for all

of the human elements involved when consumers fit helmets to their

heads, the proposed procedure is the most practical approach at this

time and should help keep the helmet secure during an accident.

Therefore, no change to the proposed standard was made in response to

this comment.

15. Vertical Vision

One commenter on the original proposal suggested that the

Commission adopt requirements for a vertical field of vision. The

Commission declined to do this because it had no information to

indicate that bicycle helmets are posing a risk of injury due to

inadequate upward or downward visual clearance.

In response to the second proposal, SwRI [2] suggested that

requirements for visual clearance at the brow be considered and that

this would be especially important for racers who ride in the crouch

position. However, a brow clearance requirement might, in some cases,

reduce the amount of head coverage in the brow area. Further, CPSC has

no information to indicate that bicycle helmets meeting existing

standards are posing a risk of injury due to inadequate ``upward''

visual clearance. Therefore, the Commission did not add a ``brow''

visual clearance requirement to the final standard.

16. Reflectivity

Some comments on the original proposal related to possible

requirements for helmets to improve a bicyclist's conspicuity in

nighttime conditions. Data do show an increased risk of injury while

bicycling during non-daylight hours. The Commission indicated that it

would 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. The Commission stated that

it would decide whether to propose reflectivity requirements for

bicycle helmets under the authority of the Bicycle Helmet Safety Act

after that work is completed.

Several commenters on the revised proposal [1, 7, 11, 13, 16, 17,

22, 23, 24, 26] urged that the Commission not postpone implementing

bicycle helmet reflectivity requirements.

Since the revised proposal, the Commission conducted field testing

on bicycle reflectors and examined the issue of reflectivity on bicycle

helmets. In the field testing, half (24/48) of the subjects were tested

using bicycle riders with reflective helmets and the other half were

tested using riders wearing non-reflective helmets. The reflective tape

used on the helmets met a proposed Standard on use of Retroreflective

Materials on Bicycle Helmets that was balloted by the ASTM Headgear

Subcommittee. The study failed to show that the particular helmet

reflective strip used in the study would increase the distance at which

a bicycle can be detected or recognized (Schroeder, 1997). Accordingly,

the Commission lacks data to support a requirement for bicycle helmet

reflective performance.

17. Hard-shell Requirements

In recommendations to the Commission, Duke University researcher

Barry Myers M.D., Ph.D., suggested that a test for penetration

resistance be considered for the final standard. He reasons that such a

test would require helmets to have hard

[[Page 11724]]

outer shells. Dr. Myers contends that a hard shell will reduce the risk

of penetration-type traumas. He further contends that a hard shell will

lessen friction between the helmet and the impact surface and that this

has two benefits. First, it would reduce the total change in velocity

(V) of the head during impact. Second, by reducing the forces

on the head caused by friction between the helmet and the impact

surface, it would reduce the risk of neck injury.

In support of hard-shell helmets, Dr. Myers references the latest

Harborview 16 study, which reported a ``consistent

suggestion that hard-shell helmets are more protective against head and

brain injuries than non-hard-shell helmets.'' Dr. Myers acknowledges

that the differences measured were not statistically significant.

However, he believes that a larger study, containing a sufficient

number of severe brain injuries, might show this correlation with

statistical significance.

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

\16\ Thompson, Diane C., MS; Rivara, Frederick P, MD, MPH; and

Thompson, Robert S., MD. ``Effectiveness of Bicycle Safety Helmets

in Preventing Head Injuries,'' Journal of the American Medical

Association 276 (December 1996): 1968-1973.

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

In discussing protection against neck injury, Dr. Myers notes that

automotive accidents cause serious neck injuries in about 15 to 25% of

the persons who have serious head injuries, suggesting that neck injury

is common among the most severely brain injured. However, since there

were so few cases with severe brain injuries in Harborview's analysis

of bicycling incidents, the significance of neck injury, and its

mitigation by hard-shell helmets, among the severe brain injured cannot

be determined from the Harborview study.

Although Dr. Myers suggests a penetration test in order to require

that bike helmets have a hard shell, he states that a detailed study of

the most severe injuries is warranted. He also recommends that, before

a requirement that all helmets have a hard shell is adopted, there

should be an evaluation of whether this would reduce the number of

riders who would wear bicycle helmets.

Currently available information does not show a need to address the

hazard of penetration-type head impacts to bicyclists. One study

17 suggests that the majority of helmets involved in bicycle

accidents suffer impacts on flat, hard surfaces (asphalt, cement, etc.)

and that penetration-type impacts are rare.

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

\17\ Dean Fisher and Terry Stern, ``Helmets Work!,'' Bell

Sports, Inc., AAAM/IRCOBI Conference, Lyon, France (September 1994).

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

Regarding the contention that requiring a hard shell may reduce

neck injuries, bicycle-related injury data show a low incidence of

serious neck injuries. In 1996, there were 566,400 bicycle-related

injuries treated in U.S. hospital emergency rooms, based on CPSC data

from NEISS. Of these, about 6,630 (1%) involved the neck. Of the neck

injuries, about 4,520 (68%) involved strains or sprains, 1,155 (17%)

involved contusions or abrasions, 275 (4%) involved lacerations, 240

(4%) involved fractures, and 440 (7%) involved other diagnoses. These

numbers show that neck fractures accounted for about 0.04% of the total

number of emergency-room-treated bicycle-related injuries in 1996.

Detailed information was not available to analyze whether the use of a

helmet or type of helmet had an effect on the risk of neck injury.

The Harborview study also reported a low incidence of neck injury.

Their report showed that 2.7% of the cases (including both helmeted and

non-helmeted cases) suffered neck injury, ranging from sprain to nerve-

cord injuries. There was no correlation between neck injury and helmet

use or helmet type.

Dr. Myers cites that automotive accidents cause serious neck

injuries in about 15 to 25% of the persons who have serious head

injuries. However, this statistic may not be relevant to the issue of

friction between the shell and the impact surface, since the neck

injuries in automotive accidents are not necessarily caused by friction

between the head and an impacting surface.

Dr. Myers' advocacy of hard-shell helmets to reduce friction would

seem to argue for a test to evaluate friction resistance of a helmet

against typical impact surfaces, rather than for a penetration-

resistance test.

One study on this issue was done by Voigt Hodgson, Ph.D., at Wayne

State University.18 In this study, test helmets were secured

to a modified Hybrid III dummy, and skid-type impacts were done on

concrete at various angles from 30 to 60 degrees. Hodgson found that

both hard-shell and micro-shell (or thin-shell) helmets tended to slide

rather than ``hang-up'' on impact with concrete. (Thin-shell helmets

are the type most commonly sold in the current market). No-shell

helmets showed a larger tendency to hang-up on impacts with concrete.

One of the conclusions of the study was that any helmet similar to

those tested in the study (hard-, thin-, or no-shell) will protect the

brain and neck much better than wearing no helmet.

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

\18\ Voigt R. Hodgson, Ph.D., ``Skid Tests on a Select Group of

Bicycle Helmets to Determine Their Head-Neck Protective

Characteristics,'' Department of Neurosurgery, Wayne State

University, Detroit, MI (March 8, 1991).

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

Harborview reports that there was a consistent trend indicating

that hard-shell helmets provided better protection against head and

brain injury than non-hard-shell helmets. However, in order for the

results to be statistically significant, the number of people in the

study would have had to be 11 times greater.

The Commission concludes that the following considerations are

relevant to any possible requirement for hard-shell bicycle helmets:

1. Studies of bicycle helmets damaged in accidents suggest that

penetration-type helmet impacts are rare occurrences. In addition,

bicycle-related injury data suggest a low incidence of serious neck

injuries. For the small portion of incidents that involve serious neck

injury or penetration-type hazards, available information is

insufficient to estimate the degree of improved protective performance

that hard-shell helmets may offer over non-hard-shell helmets.

2. Non-hard-shell bicycle helmets are effective in preventing

serious head and brain injuries. There are no known studies that report

a statistically significant finding that hard-shell helmets offer

better protection than non-hard-shell helmets.

3. A standard applying to all bicycle helmets has to balance the

protective benefit that might be provided by a hard shell against the

additional cost, weight, bulk, and discomfort caused by such a

requirement. Such undesirable qualities may discourage some users from

wearing helmets, which could more than cancel the effects of any

additional protective qualities. This is an especially important

consideration, given the popularity of non-hard-shell bicycle helmets.

After considering these factors, the Commission concludes that the

available information does not support including a penetration test, or

any other test that would require all bike helmets to have a hard

shell, in the final rule.

D. Certification Testing and Labeling

1. 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

[[Page 11725]]

``reasonable testing program.'' Regulations implementing these

certification requirements are codified in Subpart B of the Safety

Standard for Bicycle Helmets.

2. The Certification Rule

The proposed certification rule would require manufacturers of

bicycle helmets that are manufactured after the final standard becomes

effective to affix permanent labels to the helmets stating that the

helmet complies with the applicable U.S. CPSC standard. These labels

would be the ``certificates of compliance,'' as that term is used in

Sec. 14(a) of the CPSA.

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, the final rule requires an identical second label on the

helmet's package or, if the package is not visible--as when the item is

sold from a catalog, for example--on the promotional material used in

connection with the sale of the bicycle helmet.

The certification label also contains the name, address, and

telephone number 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 certification rule requires each manufacturer or importer to

conduct a reasonable testing program to demonstrate that its bicycle

helmets comply with the standard. This reasonable testing program may

be defined by the manufacturer or importer, but must include either the

tests prescribed in the standard or any other reasonable test

procedures that assure compliance with the standard.

The certification rule provides that the required testing program

will test bicycle helmets sampled from each production lot so 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 provides 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 and the importer is a U.S. resident or has a

resident agent in the U.S.

3. Reasonable Testing Program

Proposed Sec. 1203.33(b)(4) stated that 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 helmets in the lot

have been identified and destroyed or altered * * * to make them

conform to the standard.'' Trek USA [5] commented that the proposed

language describing a reasonable testing program was restrictive

because it implies that if a single helmet fails any aspect of the test

procedure, all of the product in the lot cannot be certified until

corrective action is taken. The commenter suggested a change in the

wording of Sec. 1203.33(b)(4) from ``a bicycle helmet'' to ``any

bicycle helmet'' that fails to conform to the testing criteria. The

commenter asserts that this change would provide more flexibility, as

it would remove the possibility of an anomaly in the testing causing a

lack of certification of an entire lot.

The Commission did not make the requested change in the wording of

Sec. 1203.33(b)(4). First, it does not appear that the requested

language would change the meaning of this requirement. Second, the

purpose of the testing program is to detect possible failures of

bicycle helmets in a production lot and to reasonably ensure that the

helmets that are certified comply with the standard. The Commission

intends that failure of one helmet would trigger an investigation to

determine whether the failure extends to other helmets in the

production lot. That investigation should continue until it is

reasonably likely that no noncomplying helmets remain in the production

lot. The wording of Sec. 1203.33(b)(4) has been changed to make this

intent clear.

a. Changes in Materials or Vendors

The proposed standard provides that when there are changes in

parts, suppliers, or production methods, a new production lot should be

established for the purposes of certification testing. The PHMA [29]

wants clarification of when there are material or vendor changes. PHMA

requests that the Commission use the Safety Equipment Institute

(``SEI'') guidance to help firms understand the terms material changes,

design changes, and vendor changes.

The Commission does not think that establishing definitions as

stated in the SEI ``Definition of Term'' would add any significant

clarification for the industry as a whole. Each firm can institute its

own testing program, as long as the testing program is reasonable. The

intent of the regulation is to ensure that all firms establish a

reasonable testing program and to provide flexibility for both large

and small firms. Each firm has the flexibility to define its own terms

in its quality control program, including material changes, design

changes, and vendor changes, as long as the testing program is

effective and reasonably able to determine whether all bicycle helmets

comply with the standard. The Commission made no revision to the

proposed rule in response to this comment. However, manufacturers and

importers should keep records describing the testing program and

explaining why the program is sufficient to reasonably determine that

all of the firm's bicycle helmets comply with the standard. Similarly,

when the testing program detects noncomplying helmets, the firm should

record the actions taken and why those actions are sufficient to

reasonably ensure that no noncomplying helmets remain in the production

lot. See Subpart C of Part 1203.

b. Pre-market Clearance and Market Surveillance

The Snell Memorial Foundation [28] and Paul H. Appel [25] propose

the adoption of the pre-market clearance and market surveillance

provisions of the Snell standard to ensure that quality bicycle helmets

are produced. According to the commenters, without these two Snell

provisions, Government efforts will be insufficient to keep inadequate

helmets off the market.

All firms must ensure that bicycle helmets sold in the United

States are certified to the mandatory bicycle helmet standard, and that

the certifications are based on reasonable testing programs. Firms that

distribute noncomplying products are subject to various Commission

enforcement actions. These actions include recall, injunctions, seizure

of the product, and civil or criminal penalties. The penalties for such

violations could subject a firm to penalties of up to $1.5 million and,

after notice of noncompliance, fines of up to $50,000 or imprisonment

of individuals for not more than 1 year, or both.

The Commission has statutory authority to inspect manufacturers,

importers, distributors, and retailers of bicycle helmets. This

authority includes the right to review and copy records relevant to

compliance with the bicycle helmet standard. The Commission may also

collect samples of bicycle helmets for testing to the standard.

The Commission has a vigorous enforcement program that includes

joint import surveillance with U.S. Customs and compliance surveillance

of domestic producers, distributors, and retailers. In addition, the

staff responds

[[Page 11726]]

to all reports of noncompliance with all mandatory standards.

From previous history with other regulations that the Commission

enforces, compliance with the various CPSC standards is high. In

addition, all firms have a responsibility to report noncompliance with

the standard under Section 15(b) of the Consumer Product Safety Act. 15

U.S.C. 2064(b). Failure to report could subject a firm to severe

penalties.

Based on these considerations, the agency's enforcement programs

and enforcement authority will provide substantial assurance that

bicycle helmets will meet the requirements for the mandatory standard.

Experience in enforcing other CPSC regulations has shown that a high

degree of compliance can be achieved without manufacturers using a pre-

market clearance program or a third-party certifying organization.

Therefore, the Commission made no revision to the proposed rule in

response to this comment.

4. Certificate of Compliance

a. Coding of Date of Manufacture

The proposed standard required the certification label to contain

the month and year of manufacture, but allowed this information to be

in code. Mr. L.E. Oldendorf, P.E., from ASSE[11], the Bicycle Helmet

Safety Institute (``BHSI'') [16], the Bicycle Federation of Wisconsin

[24], and Paula Romeo [26] opposed allowing manufacturers to code the

month and year of manufacture. These commenters felt that uncoded dates

would help consumers determine whether their helmet was subject to a

recall. One commenter stated that an uncoded production date is

necessary to assist consumers when they wish to replace their helmet

after 5 years.

As the commenters noted, an uncoded manufacture date would make it

easier for consumers to tell when their helmets are subject to a

recall. This information also would help users determine when the

helmet's useful life is over and the helmet should be replaced. Snell

helmet standards require that the manufacture date be uncoded, and it

is already a common practice in the industry. Accordingly, the

Commission has revised the standard to require an uncoded date of

manufacture.

b. Telephone Number on Label

Two commenters [23 and 26] urged that the Commission require labels

showing the manufacturer's telephone number. They stated that this

requirement would make it easier for the consumer to contact the

manufacturer about recall information and about instructions for

returning the helmet to the manufacturer after it has been damaged.

The telephone number would be helpful for consumers during a recall

or to inquire about a damaged bicycle helmet because they could

determine the status of their helmets quicker than by a written

inquiry. Obtaining a quicker response would enable the consumer to

replace a defective helmet sooner and thus reduce the possibility of

injuries caused by having an accident while wearing a defective helmet.

Therefore, the Commission is requiring the telephone number of the U.S.

manufacturer or importer on the helmet's labeling.

c. Certification Label on Children's Helmets

PHMA [29] suggested that a label showing certification for children

under 5 is needed on the packaging, but is not needed inside the

helmet.

The Commission does not agree. Since helmets for small children are

likely to be shared with or passed on to multiple users, the sticker on

the helmet is likely to be the only source of information available to

the second or third user. Further, it is common to display helmets at

retail without the box. Thus, the purchaser may not see the box until

after selecting the model, if at all. Therefore, this labeling will be

required on both the box and the helmet.

d. Minimum Age on Labels for Children's Helmets

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)''.

This was changed in the revised proposal because the Commission wanted

to guard against the possibility that small adult helmets will be

purchased for children. Therefore, the revised proposed standard

required that helmets that do not comply with the requirements for

young children's helmets would be labeled ``Complies with CPSC Safety

Standard for Bicycle Helmets for Adults and Children Age 5 and Older

(16 CFR 1203)''. Under that proposal, 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)''. That proposal further provided that 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.

Maurice Keenan, MD, from the American Academy of Pediatrics [21],

requested that a minimum age of 1 year be reflected on the label for

helmets intended for children under age 5. This would better convey the

message that infants (children under age 1) should not be passengers on

a bicycle under any circumstance.

The Commission agrees with the commenter that children under 1 year

of age should not be on bicycles. Children are just learning to sit

unsupported at about 9 months of age. Until this age, infants have not

developed sufficient bone mass and muscle tone to enable them to sit

unsupported with their backs straight. Pediatricians advise against

having infants sitting in a slumped or curled position for prolonged

periods. This position may even be exacerbated by the added weight of a

bicycle helmet on the infant's head. Because pediatricians recommend

against having children under age 1 as passengers on bicycles, the

Commission does not want the certification label to imply that children

under age 1 can ride safely. Thus, the proposed language that a helmet

complies with CPSC's standard ``for Children Under 5 Years'' or ``for

persons of all ages'' is not suitable, since these phrases include

children less than 1 year old.

Further, the only difference between the final requirements for

helmets for children of ages 1-4 and for helmets for older persons is

that the young children's helmets cover more of the head. Therefore,

children's helmets will inherently comply with the requirements for

helmets for older persons, and the label need not indicate an upper

cutoff of age 5 for meeting CPSC's requirements.

For the reasons given above, the proposed label indicating that

helmets comply with the standard for helmets for children under 5 years

has been amended to state that the helmets comply with the CPSC

standard for ``persons age 1 and older.''

e. Identifying the Commission

The NSKC [22] encouraged the Commission to modify the certification

labeling to require the language ``United States Consumer Product

Safety Commission'' rather than ``CPSC.'' The commenter believes that

the acronym is likely to lead to consumer confusion, but that the use

of the full name of the Commission will clearly identify the

[[Page 11727]]

helmet as meeting a federal safety standard.

The rationale presented by the commenter for using the full name of

the Commission instead of using the acronym is logical. However, the

use of the Commission's full name may be impractical for some

manufacturers. The amount of space available on the inside of a helmet

is limited. The proposed regulation requires a number of labels, and

each one is supposed to be legible and easily visible to the user.

Allowing the use of the acronym is a necessary compromise so that all

the labels can be accommodated on the inside of the helmet. However,

the Commission concluded that the acronym should include the

designation ``U.S.'' before ``CPSC'' to indicate that the standard is

issued by an agency of the Federal Government. Further, the Commission

believes manufacturers should have the choice of whether to use the

acronym or spell out the agency's name. Accordingly, the following

wording has been added to Secs. 1203.34(b)(1) and 1203.34(d): ``this

label may spell out `U.S. Consumer Product Safety Commission' instead

of `U.S. CPSC'.''

f. Certification Label on Packaging

The proposed standard provided that the certification compliance

label shall also be on the helmets' packaging or promotional material

if the label is not immediately visible on the product. NSKC [22]

requested that the final standard require that such package label be

legible and prominent, and placed on the main display panel of the

packaging so that it is easily visible to the purchaser.

The Commission agrees with the commenter and has added the

following wording to Sec. 1203.34(d): ``The label shall be legible,

readily visible, and placed on the main display panel of the packaging

or, if the packaging is not visible before purchase (e.g., catalog

sales), on the promotional material used with the sale of the bicycle

helmet.''

E. Recordkeeping

1. Introduction

Section 16(b) of the CPSA requires that:

Every 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 requires every entity issuing certificates of compliance

for bicycle helmets to maintain records that show the certificates are

based on a reasonable testing program. 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 to

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).

2. 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. In response to a comment on

the original proposal, the Commission revised the 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.

SwRI [2] commented that the 48-hour allowance to provide test

records to the Commission should apply to all manufacturers or

importers, whether or not the test records are maintained within the

U.S.

The Commission agrees with this comment, and the final rule

provides that all firms are required to provide records for immediate

inspection and copying upon request by a Commission employee. If the

records are not physically available during the inspection because they

are maintained at another location, the firm must provide them to the

staff within 48 hours.

3. Length of Records Retention

Paula Romeo [26] raised the issue of whether certification records

should be maintained for longer than 3 years, since helmets can be used

for 5 years.

The purpose of records being kept for 3 years is to ensure that the

helmets have time to clear the distribution channels and get into the

marketplace. If there is a compliance problem or defect in the helmets,

3 years would be sufficient to uncover any problems with the helmets.

The Commission's staff would have time to obtain the records to review

the firm's testing program and take any necessary enforcement action

during this 3-year period. Therefore, no change was made in the rule in

response to this comment.

F. Regulatory Flexibility Act Certification

Introduction

When an agency undertakes a rulemaking proceeding, the Regulatory

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

prepare initial 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

Sec. 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. The Regulatory Flexibility 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. 5 U.S.C. 605.

The Commission's Previous Economic Findings

In the August 1994 notice of proposed rulemaking, the Commission

noted that any costs associated with design changes to comply with the

original proposal would be spread out over the course of production,

and would be small on a per-unit basis. Costs associated with testing

and monitoring were not expected to increase, since the vast majority

of firms already used third parties to test for conformance to the

voluntary standards. The proposal also allowed for self-certification

and self-monitoring which, for some companies, may be substantially

less costly than third-party certification. The proposed labeling

requirements were not expected to have a significant impact on small

firms, in that virtually all helmets already bore a similar label.

Based on this information, the Commission preliminarily concluded that

the proposal would not have a significant impact on a substantial

number of small entities. The Commission received no public comment on

this conclusion.

As a result of non-economic comments of a technical nature, the

Commission proposed a revised standard on December 6, 1995. In that

notice, the Commission reiterated its assessment of the economic impact

of the standard on small businesses. In the preamble to the 1995

proposal, the Commission again preliminarily certified that the

proposed standard, if promulgated, would not have a significant

economic effect on a substantial number of small entities.

Current Economic Assessment and Response to Comments

The Commission's Directorate for Economics prepared an economic

assessment of the safety standard for

[[Page 11728]]

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

(or more) of three existing voluntary standards. Many of these helmets

probably already comply with the impact attenuation requirements of the

new rule. On a per-unit basis, costs associated with redesign and

testing are expected to be small.

The standard's labeling requirements are unlikely to have a

significant impact on firms, since virtually all bicycle helmets now

bear a permanent label on their inside surface. Industry sources report

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

cost of labeling would be insignificant.

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 standard allows for self-certification and

self-monitoring, however, which is substantially less costly than

third-party testing and monitoring.

The Commission received two comments on the 1995 proposal that

related to the economic effects of the revision. These involved the

cost associated with the specification of a monorail test device, and

the effect of the curbstone testing procedure.

A comment from Trek Bicycle Corporation [5] approved specifying a

single test apparatus, but was concerned that the Commission chose a

monorail-guided test rig over a guidewire unit. Trek said that the

majority of PHMA members test on wire-guided equipment and that some

firms may be forced to purchase monorail units to eliminate product

liability concerns. The firm stated, ``[t]he burden of this unnecessary

expense may provide need for additional analysis of the financial

impact to small business, as required by the Regulatory Flexibility

Act.''

Based on contacts with industry and testing facilities, it appears

that, of those manufacturers that have in-house test labs, an estimated

5 to 10 have only a wire-guided rig. Most commercial, independent, and

academic bicycle helmet test labs have a monorail test rig, and many of

those labs also have one or more wire-guided rigs. The estimated cost

to purchase a monorail-guided rig is about $20,000.

An interlaboratory study comparing the results of monorail and

guidewire test rigs showed no significant differences between the two

types of rigs in test conditions that are within the parameters

permitted by the draft standard. Therefore, the final standard has been

revised to specify that either a monorail or a guidewire apparatus may

be used to test a helmet's impact attenuation performance.

Consequently, the potential cost considerations for laboratories using

guidewire rigs no longer apply.

Another commenter, Bell Sports [12], noted that the proposal also

included impact testing requirements that allowed two impacts with a

device simulating helmet contact with a curb. Bell estimated that

``[t]he addition of the curbstone anvil * * * and with the option of

using it twice on any helmet might well increase the retail price of

bicycle helmets by $2.00 to $10.00.''

The standard is intended to address helmet safety from a single

impact on a given area. For this reason, the impact testing requirement

has been changed to require only a single curbstone impact simulation

test per helmet test sample. Consequently, the potential changes in

helmet design that could have been needed to comply with two curbstone

impact tests no longer apply.

Small Business Effects

Of the 30 current manufacturers of bicycle helmets, all but two

would be considered small businesses under Small Business

Administration employment criteria (less than 100 employees). As the

Commission found previously, the one-time costs of design are expected

to be small on a per-unit basis.

Spokesmen for the PHMA estimate that there are 1,000 to 1,500

bicycle-helmet molds in current use, each of which contains 4 molding

cavities. Redesign may be required for one or more cavities in some

molds, while other molds may not require any cavity redesign. Using a

midpoint estimate of 1,250 molds, there would be some 5,000 cavities in

current use in helmet molds.

The PHMA estimates that the top 4 manufacturers of bicycle helmets

account for about 700 molds (or some 2,800 cavities) used in helmet

production. The other 26 firms account for the remainder or, on

average, 21 molds per firm (84 cavities). The PHMA estimates that 10%

or less of the existing cavities would require redesign in order for

the helmets made by them to comply with the standard. Thus, smaller

firms may need to redesign an average of 8.4 cavities. Each cavity

costs approximately $2,500, according to the trade association. On

average, the one-time cost of cavity redesign for the smaller 26 firms

would be about $21,000 each.

The top 4 firms account for an estimated 75% of the 9 million

helmets sold annually, according to PHMA. The remaining firms thus

account for 25%, or 2.25 million helmets annually. If sales are

allocated uniformly, each of the 26 firms would account for about

87,000 units. If spread over a single year's production, the average

cavity redesign cost would be about 24 cents per helmet.

Further, the industry routinely replaces molds (and, thus,

cavities), either because of style changes in helmet designs or because

they wear out. The above estimates, however, assume that no molds would

have been replaced absent the standard. Because the standard will not

become effective until 1 year after the final rule is published, some

of the noncomplying cavities may be replaced in that interim for

reasons independent of the final standard. Consequently, the estimated

one-time costs associated with the replacement of the smaller firms'

mold cavities that would be attributed solely to the standard are

likely to be significantly less than $21,000 each.

Regulatory Flexibility Certification

Because the per-unit costs of modifying production molds will be

relatively low, the Commission concludes that the rule will not have a

significant impact 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 assessed the

possible environmental effects associated with the 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. The analysis of the potential impact

of this 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 Sec. 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. Industry experts estimate that

there are some 1,000 to 1,500 molds currently used by bicycle helmet

producers, and that perhaps 10% are likely to be affected by the

proposed standard. Molds are constructed of aluminum, commonly weighing

40-50 pounds each. Molds are also routinely replaced

[[Page 11729]]

due to wear or to changes in style. Helmet manufacturers send these

older molds back to the firm making replacements, and the older units

are melted down for use in the replacement molds. Thus, the quantity of

discards resulting from 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 will 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 this rule.

Accordingly, neither an environmental assessment nor an environmental

impact statement is required.

H. Paperwork Reduction Act

As noted above, U.S. manufacturers and importers of bicycle helmets

will be required to conduct a reasonable testing program to ensure

their products comply with the standard. They will also be 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 will also have to label their products

with specified information.

The rule thus contains ``collection of information requirements''

subject to the Paperwork Reduction Act of 1995, 15 U.S.C. 3501-3520,

Pub. L. No. 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 submitted the proposed collection

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

the Paperwork Reduction Act of 1995.

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 advised 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 additional burden of the final

collection of information requirements is expected to be only a small

fraction of the total hours given above.

The Commission solicited 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.

No comments directly addressed the Commission's burden estimate.

Comments addressing the topic of reducing the number of helmets

required to be tested under the standard are discussed in section C of

this notice.

I. Executive Orders

This rule has been evaluated for federalism implications in

accordance with Executive Order No. 12,612, and the rule raises no

substantial federalism concerns.

Executive Order No. 12,988 requires agencies to state the

preemptive effect, if any, to be given to the regulation. The

preemptive effect of this rule is established by 15 U.S.C. 2075(a),

which states:

(a) Whenever a consumer product safety standard under [the CPSA]

is in effect and applies to a risk of injury associated with a

consumer product, no State or political subdivision of a State shall

have any authority either to establish or to continue in effect any

provision of a safety standard or regulation which prescribed any

requirements as to the performance, composition, contents, design,

finish, construction, packaging, or labeling of such product which

are designed to deal with the same risk of injury associated with

such consumer product, unless such requirements are identical to the

requirements of the Federal standard.

Subsection (b) of 15 U.S.C. 2075 provides that subsection (a) does

not prevent the Federal Government or the government of any State or

political subdivision of a State from establishing or continuing in

effect a safety standard applicable to a consumer product for its own

(governmental) use, and which is not identical to the consumer product

safety standard applicable to the product under the CPSA, if the

Federal, State, or political subdivision requirement provides a higher

degree of protection from such risk of injury than the consumer product

safety standard.

Subsection (c) of 15 U.S.C. 2075 authorizes a State or a political

subdivision of a State to request an exemption from the preemptive

effect of a consumer product safety standard. The Commission may grant

such a request, by rule, where the State or political subdivision

standard or regulation (1) provides a significantly higher degree of

protection from such risk of injury than the consumer product safety

standard and (2) does not unduly burden interstate commerce.

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 revises 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, general requirements, and effective date.

1203.2 Purpose and basis.

1203.3 Referenced documents.

1203.4 Definitions.

1203.5 Construction requirements--projections.

1203.6 Labeling and instructions.

1203.7 Samples for testing.

1203.8 Conditioning environments.

1203.9 Test headforms.

1203.10 Selecting the test headform.

1203.11 Marking the impact 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.

Subpart B--Certification

1203.30 Purpose, basis, and scope.

1203.31 Applicability 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--Requirements for Bicycle Helmets Manufactured From March 17,

1995, Through March 10, 1999

1203.51 Purpose and basis.

1203.52 Scope and effective date.

1203.53 Interim safety standards.

Figures to Part 1203

Authority: 15 U.S.C. 2056, 2058, and 6001-6006. Subpart B is

also issued under 15

[[Page 11730]]

U.S.C. 2063. Subpart C is also issued under 15 U.S.C. 2065.

Subpart A--The Standard

Sec. 1203.1 Scope, general requirements, and effective date.

(a) Scope. The standard in this subpart describes test methods and

defines minimum performance criteria for all bicycle helmets, as

defined in Sec. 1203.4(b).

(b) General requirements.

(1) Projections. All projections on bicycle helmets must meet the

construction requirements of Sec. 1203.5.

(2) Labeling and instructions. All bicycle helmets must have the

labeling and instructions required by Sec. 1203.6.

(3) Performance tests. All bicycle helmets must be capable of

meeting the peripheral vision, positional stability, dynamic strength

of retention system, and impact-attenuation tests described in

Secs. 1203.7 through 1203.17.

(4) Units. The values stated in International System of Units

(``SI'') measurements are the standard. The inch-pound values stated in

parentheses are for information only.

(c) Effective date. The standard shall become effective March 10,

1999 and shall apply to all bicycle helmets manufactured after that

date. Bicycle helmets manufactured from March 17, 1995 through March

10, 1999, inclusive, are subject to the requirements of Subpart D,

rather than this subpart A.

Sec. 1203.2 Purpose and basis.

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, pursuant to 15 U.S.C. 6001-6006.

Sec. 1203.3 Referenced documents.

(a) The following documents are incorporated by reference in this

standard.

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

Testing of Protective Helmets.\1\

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

\1\ Although the draft ISO/DIS 6220-1983 standard was never

adopted as an international standard, it has become a consensus

national standard because all recent major voluntary standards used

in the United States for testing bicycle helmets establish their

headform dimensions by referring to the draft ISO standard.

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

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

Impact Tests.

(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

draft ISO/DIS Standard 6220-1983 are available from American National

Standards Institute, 11 W. 42nd St., 13th Floor, New York, NY 10036.

Copies of the SAE Recommended Practice SAE J211 OCT88, Instrumentation

for Impact Tests, are available from Society of Automotive Engineers,

400 Commonwealth Dr., Warrendale, PA 15096. 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.

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 of this part).

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

or implied through marketing or promotion to be, a device intended to

provide protection from head injuries while riding a

bicycle.2

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

\1\ Helmets specifically marketed for exclusive use in a

designated activity, such as skateboarding, rollerblading, baseball,

roller hockey, etc., would be excluded from this definition because

the specific focus of their marketing makes it unlikely that such

helmets would be purchased for other than their stated use. However,

a multi-purpose helmet--one marketed or represented as providing

protection either during general use or in a variety of specific

activities other than bicycling--would fall within the definition of

bicycle helmet if a reasonable consumer could conclude, based on the

helmet's marketing or representations, that bicycling is among the

activities in which the helmet is intended to be used. In making

this determination, the Commission will consider the types of

specific activities, if any, for which the helmet is marketed, the

similarity of the appearance, design, and construction of the helmet

to other helmets marketed or recognized as bicycle helmets, and the

presence, prominence, and clarity of any warnings, on the helmet or

its packaging or promotional materials, against the use of the

helmet as a bicycle helmet. A multi-purpose helmet marketed without

specific reference to the activities in which the helmet is to be

used will be presumed to be a bicycle helmet. The presence of

warnings or disclaimers advising against the use of a multi-purpose

helmet during bicycling is a relevant, but not necessarily

controlling, factor in the determination of whether a multi-purpose

helmet is a bicycle helmet.

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

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

configure the helmet for a range of different head sizes.

(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 of this part).

(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. This vertical distance shall be specified by the

manufacturer for each size of each model of the manufacturer's helmets,

for the appropriate size of headform for each helmet, as described in

Sec. 1203.10.

(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 of 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. The MEP shall be 152 mm

(6 in) in diameter, and 25 mm (1 in) thick and shall have a durometer

of 60 2 Shore A. The MEP shall be affixed to the top

surface of a flat 6.35 mm (\1/4\ in) thick aluminum plate. See

Sec. 1203.17(b)(1).

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

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 of 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

of 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 an impact fixture used in the instrument

system check of Sec. 1203.17(b)(1) to test the impact-attenuation test

equipment for

[[Page 11731]]

precision and accuracy. The spherical impactor shall be a 146 mm (5.75

in) diameter aluminum sphere mounted on the ball-arm connector of the

drop assembly. The total mass of the spherical-impactor drop assembly

shall be 5.0 0.1 kg (11.0 0.22 lb).

(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

low-resonance K-1A magnesium alloy. The test headforms shall include

surface markings corresponding to the basic, coronal, midsagittal, and

reference planes (see Figure 2 of this part).

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

impact test line, that is subject to impact testing.

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. There shall be no

fixture on the helmet's inner surface projecting more than 2 mm into

the helmet interior.

Sec. 1203.6 Labeling and instructions.

(a) Labeling. Each helmet shall be marked with durable labeling so

that the following information is legible and easily visible to the

user:

(1) Model designation.

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

possible impacts and that serious injury or death could occur.

(3) A warning on both the helmet and the packaging 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

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 [ammonia],

cleaners [bleach], etc.), and that this damage may not be visible to

the user. This label shall state in generic terms some recommended

cleaning agents and procedures (for example, wipe with mild soap and

water), list the most common substances that damage the helmet, warn

against contacting the helmet with these substances, and refer users to

the instruction manual for more specific care and cleaning information.

(6) Signal word. The labels required by paragraphs (a) (2) through

(5) of this section shall include the signal word ``WARNING'' at the

beginning of each statement, unless two or more of the statements

appear together on the same label. In that case, the signal word need

only appear once, at the beginning of the warnings. The signal word

``WARNING'' shall be in all capital letters, bold print, and a type

size equal to or greater than the other text on the label.

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

instructions, including a 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. To meet the standard, the helmets must be able to

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. To test conformance to this standard, eight

samples of each helmet size for each helmet model offered for sale are

required.

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 in of Hg). All test helmets shall be stabilized

within the ambient condition 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% relative humidity. The ambient test helmet does not need further

conditioning.

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

-17 deg.C to -13 deg.C (1 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 mm 25 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 selected from sizes A, E,

J, M, and O, as defined by DRAFT ISO/DIS 6220-1983, in accordance with

Sec. 1203.10. Headforms used for impact testing shall be rigid and be

constructed of low-resonance K-1A magnesium alloy.

Sec. 1203.10 Selecting the test headform.

A helmet shall be tested on the smallest of the headforms

appropriate for the helmet sample. A headform size is appropriate for a

helmet if all of the helmet's sizing pads are partially compressed when

the helmet is equipped with its thickest sizing pads and positioned

correctly on the reference headform.

Sec. 1203.11 Marking the impact test line.

Prior to testing, the impact 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 helmet 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 the impact 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 of this part for helmets intended only for persons 5

years of age and older.

(2) Figure 5 of this part for helmets intended for persons age 1

and older.

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

on the helmet on or above the impact test line.

Sec. 1203.12 Test requirements.

(a) Peripheral vision. All bicycle helmets 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. No bicycle helmet shall come off of the

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

standard.

(c) Dynamic strength of retention system. All bicycle helmets shall

have a retention system that will remain intact without elongating more

than 30 mm (1.2 in.) when tested in accordance with Sec. 1203.16 of

this standard.

[[Page 11732]]

(d) Impact attenuation criteria.

(1) General. A helmet fails the impact attenuation performance test

of this standard if a failure under paragraph (d)(2) of this section

can be induced under any combination of impact site, anvil type, anvil

impact order, or conditioning environment permissible under the

standard, either with or without any attachments, or combinations of

attachments, that are provided with the helmet. Thus, the Commission

will test for a ``worst case'' combination of test parameters. What

constitutes a worst case may vary, depending on the particular helmet

involved.

(2) Peak acceleration. 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.

Sec. 1203.13 Test schedule.

(a) Helmet sample 1 of the set of eight helmets, as designated in

Table 1203.13, shall be tested for peripheral vision in accordance with

Sec. 1203.14 of this standard.

(b) Helmet samples 1 through 8, as designated in Table 1203.13,

shall be conditioned in the ambient, high temperature, low temperature,

and water immersion environments as follows: helmets 1 and 5--ambient;

helmets 2 and 7--high temperature; helmets 3 and 6--low temperature;

and helmets 4 and 8--water immersion.

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

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

conditioning environment within 3 minutes after it was removed, and

shall remain in the conditioning environment for a minimum of 2 minutes

before testing is resumed. If the helmet is out of the conditioning

environment beyond 3 minutes, testing shall not resume until the helmet

has been reconditioned for a period equal to at least 5 minutes for

each minute the helmet was out of the conditioning environment beyond

the first 3 minutes, or for 4 hours, (whichever reconditioning time is

shorter) before testing is resumed.

(d) Prior to being tested for impact attenuation, helmets 1-4

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

immersion environments, respectively) shall be tested in accordance

with the dynamic retention system strength test at Sec. 1203.16.

Helmets 1-4 shall then be tested in accordance with the impact

attenuation tests on the flat and hemispherical anvils in accordance

with the procedure at Sec. 1203.17. Helmet 5 (ambient-conditioned)

shall be tested in accordance with the positional stability tests at

Sec. 1203.15 prior to impact testing. Helmets 5-8 shall then be tested

in accordance with the impact attenuation tests on the curbstone anvil

in accordance with Sec. 1203.17. Table 1203.13 summarizes the test

schedule.

Table 1203.13.--Test Schedule

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

Sec. Sec. 1203.17 Impact tests

Sec. Sec. 1203.16 ----------------------------------

1203.14 1203.15 Retention Number of

Peripheral Positional system Anvil Impacts

----------------------------------------vision-------stability-----strength-------------------------------------

Helmet 1, Ambient.................. X ............ X X Flat............. 2

X Hemi............. 2

Helmet 2, High Temperature......... ............ ............ X X Flat............. 2

X Hemi............. 2

Helmet 3, Low Temperature.......... ............ ............ X X Flat............. 2

X Hemi............. 2

Helmet 4, Water Immersion.......... ............ ............ X X Flat............. 2

X Hemi............. 2

Helmet 5, Ambient.................. ............ X ............ X Curb............. 1

Helmet 6, Low Temperature.......... ............ ............ ............ X Curb............. 1

Helmet 7, High Temperature......... ............ ............ ............ X Curb............. 1

Helmet 8, Water Immersion.......... ............ ............ ............ X Curb............. 1

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

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 of 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 from point K on each side of the

midsagittal plane.

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

(a) Test equipment.

(1) Headforms. 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 the headform's vertical axis pointing downward and 45 degrees to

the direction of gravity (see Figure 7 of 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 the 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

of this part). 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

[[Page 11733]]

the midsagittal plane and attaching the hook over the edge of the

helmet as shown in Figure 7 of this part.

(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's 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

of this part). Two cylindrical rollers that spin freely, with a

diameter of 12.5 0.5 mm (0.49 in. 0.02 in.)

and a center-to-center distance of 76.0 1 mm (3.0

0.04 in.), shall make up a stirrup that represents the

bone structure of the 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 kg

0.5 kg (24.2 lb 1.1 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 of this part, are two methods of measuring the elongation.

Sec. 1203.17 Impact attenuation test.

(a) Impact 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 or guidewire test apparatus (see Figure 9 of this part), onto

an anvil fixed to a rigid base. The center of the anvil shall be

aligned with the center vertical axis of the accelerometer. 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 shall be 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 shal

This text is long and has been trimmed here. Open the source document for the complete record.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

A word about cookies

We need a few to keep you signed in and the library working. The rest help us see which pages people use and where they get stuck. They stay off unless you say yes.

Safety Standard for Bicycle Helmets · 63 FR 11712 | Frix