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federalregister 11711 Tuesday March 10, 1998 Part II Consumer Product Safety Commission 16 CFR Part 1203 Safety Standard for Bicycle Helmets; Final Rule

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Page 1: federal register - helmets.orghelmets.org/cpscstd.pdfHelmets,’’ The New England Journal of Medicine 320 (May 1989): 1361–1367. 8 Recent research indicated that helmets reduced

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11711

TuesdayMarch 10, 1998

Part II

Consumer ProductSafety Commission16 CFR Part 1203Safety Standard for Bicycle Helmets;Final Rule

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11712 Federal Register / Vol. 63, No. 46 / Tuesday, March 10, 1998 / Rules and Regulations

1 The standard was approved by the Commissionunanimously, by a vote of 3–0. Chairman AnneBrown, Commissioner Mary S. Gall, andCommissioner Thomas Moore each issued aseparate statement concerning the vote. Copies ofthese statements are available from the Office of theSecretary.

2 Sacks, Jeffrey, J., MPH; Holmgreen, Patricia, MS;Smith, Suzanne M., MD; Sosin, Daniel M., MD.‘‘Bicycle-Associated Head Injuries and Deaths inthe United States from 1984 through 1988,’’ Journalof the American Medical Association 266(December 1991): 3016–3018. Sosin, Daniel M., MD,MPH; Sacks, Jeffrey J., MD, MPH; and Webb, KevinW., ‘‘Pediatric Head Injuries and Deaths fromBicycling in the United States,’’ Pediatrics 98(November 1996): 868–870.

CONSUMER PRODUCT SAFETYCOMMISSION

16 CFR Part 1203

Safety Standard for Bicycle Helmets

AGENCY: Consumer Product SafetyCommission.ACTION: Final rule.

SUMMARY: Pursuant to the Children’sBicycle Helmet Safety Act of 1994, theCommission is issuing a safety standardthat will require all bicycle helmets tomeet impact-attenuation and otherrequirements.

The standard establishes requirementsderived from one or more of thevoluntary standards applicable tobicycle helmets. In addition, thestandard includes requirementsspecifically applicable to children’shelmets and requirements to preventhelmets from coming off during anaccident. The standard also containstesting and recordkeeping requirementsto ensure that bicycle helmets meet thestandard’s requirements.DATES: Effective Date: This rule iseffective March 10, 1999.

Applicability Dates: This rule appliesto bicycle helmets manufactured afterMarch 10, 1999. Interim mandatorystandards that went into effect on March17, 1995, will continue to apply tobicycle helmets manufactured fromMarch 17, 1995, until March 10, 1999,inclusive. In addition, as of March 10,1998, firms will have the option ofmarketing helmets meeting the standardin this final rule before its effective date.

Incorporation by Reference: Theincorporation by reference of certainpublications listed in the rule isapproved by the Director of the FederalRegister 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 Background1. 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 Standard1. 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 Changes1. 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 Labeling1. 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. Recordkeeping1. General.2. Location of test records—time for

production.3. Length of records retention.

F. Regulatory Flexibility Act CertificationG. Environmental ConsiderationsH. Paperwork Reduction ActI. Executive OrdersList of Subjects in 16 CFR Part 1203Part 1203—Safety Standard for Bicycle

Helmets

A. Introduction and Background

1. IntroductionIn this notice, the United States

Consumer Product Safety Commission(‘‘Commission’’ or ‘‘CPSC’’) issues amandatory safety standard for bicyclehelmets.1

2. Injury and Death DataData from the National Center for

Health Statistics (‘‘NCHS’’) indicatedthat in 1993 there were 907 pedalcyclist(primarily bicycle-related) deaths in theUnited States. Of these, 17 (about 2%)were of children under the age of 5years. Research has shown thatapproximately 60% of all bicycle-related deaths involved head injury. Forchildren under age 5, about 64%involved head injury.2 Information onthe impact forces involved in these fatalincidents was not available, althoughabout 90% of the pedalcyclist deaths,including those of children under age 5,involved collisions with motor vehicles.

Based on data from CPSC’s NationalElectronic Injury Surveillance System(‘‘NEISS’’), there were an estimated566,400 bicycle-related injuries treatedin U.S. hospital emergency rooms in1996. Of these, approximately 30%involved the head and face. A higherproportion of head injuries and facialinjuries occurred to young children thanto older victims.

CPSC’s NEISS data showed that thetypes of injuries to young children weresomewhat different from those to olderchildren and adults. Younger childrenhad a smaller proportion of concussionsand internal injuries to the head thandid older victims, as well as a largerproportion of relatively minor headinjuries (i.e., lacerations, contusions,and abrasions). The extent to whichthese differences can be attributed to theuse of helmets, other aspects of thehazard scenario, or the physiology ofyoung children, is not known. It is alsopossible that caregivers are more likelyto bring young children to theemergency room for relatively minorinjuries.

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11713Federal Register / Vol. 63, No. 46 / Tuesday, March 10, 1998 / Rules and Regulations

3 Tinsworth, Deborah K., MS; Polen, Curtis; andCassidy, Suzanne. ‘‘Bicycle-Related Injuries: Injury,Hazard, and Risk Patterns,’’ International Journalfor Consumer Safety I (December 1994): 207–220.

4 Rogers, Gregory B. ‘‘The Characteristics and UsePatterns of Bicycle Riders in the United States,’’Journal of Safety Research 25 (1994): 83–96.

5 Thompson, Diane C., MS; Rivara, Frederick P.,MD, MPH; and Thompson, Robert S., MD.‘‘Effectiveness of Bicycle Safety Helmets inPreventing Head Injuries,’’ Journal of the AmericanMedical Association 276 (December 1996): 1968–1973.

6 The estimated reduction in risk for children 6–12 years of age was 70%.

7 Thompson, Robert S., MD; Rivara, Frederick P.,MD, MPH; and Thompson, Diane C., MS. ‘‘A CaseControl Study of the Effectiveness of Bicycle SafetyHelmets,’’ The New England Journal of Medicine320 (May 1989): 1361–1367.

8 Recent research indicated that helmets reducedthe risk of serious injury to the upper and middleface by about 65%, but had no significant effect onserious injury to the lower face. Thompson, DianeC., MS; Nunn, Martha E., DDS; Thompson, RobertS., MD; and Rivara, Frederick P., MD, MPH.‘‘Effectiveness of Bicycle Safety Helmets inPreventing Serious Facial Injury.’’ Journal of theAmerican Medical Association 276 (December1996): 1974–1975.

A 1993 Commission staff study ofbicycle hazards indicated that whenother factors were held constantstatistically, the injury risk for childrenunder age 15 was over five times therisk for older riders.3 This study alsoindicated that children were atparticular risk of head injury. Aboutone-half of the injuries to childrenunder age 10 involved the head,compared to one-fifth of the injuries toolder riders. This may have been in partbecause children were significantly lesslikely to have been wearing a helmetthan were older victims (5% of victimsyounger than 15 were wearing a helmet,compared to 30% of those 15 and older).However, detailed information relatingthe type of helmet, age of user, andother aspects of the hazard scenario tohead injury severity was not availablefrom that study. A Commission study onbicycle and helmet usage patterns foundthat in 1993 about 18% of bicyclistswore helmets.4

A 1996 study of about 3,400 injuredbicyclists in the Seattle, Washington,area included an evaluation of theprotective effectiveness of helmets indifferent age groups.5 When bicycliststreated in hospital emergency rooms forhead injuries were compared tobicyclists who sought care for othertypes of injuries at the same emergencyrooms, helmet use was associated witha reduction in the risk of any headinjury by 69%, brain injury by 65%, andsevere brain injury by 74%.

By age group, this study showed thatthe reduction in the risk of head injuryranged from 73% for children under 6years to 59% for teens in the 13–19year-old age group.6 Based on the resultsof their study, the authors concludedthat helmets were effective for allbicyclists, regardless of age, and thatthere was no evidence that childrenyounger than 6 years need a differenttype of helmet. However, for childrenyounger than 6 years, there was onlyone helmeted child with a brain injury(a concussion), and no helmetedchildren with severe brain injuries.Thus, the protective effects of helmetson brain injuries and severe brain

injuries were not calculated for this agegroup.

A widely-cited 1989 study, publishedby the same authors, found that riderswith helmets had an 85% reduction intheir risk of head injury, and an 88%reduction in their risk of brain injury,when compared to cyclists withouthelmets.7 These results were foundwhen patients who sought emergencyroom care for bicycle-related headinjuries were compared to bicyclists inthe community who had crashes,regardless of injury or medical care. Arecent study indicated that helmets mayprotect more against head injuries thanagainst some facial injuries.8

3. The Children’s Bicycle Helmet SafetyAct of 1994

On June 16, 1994, the Children’sBicycle Helmet Safety Act of 1994 (the‘‘Act’’ or ‘‘the Bicycle Helmet SafetyAct’’) became law. 15 U.S.C. 6001–6006.The Act provides that bicycle helmetsmanufactured after March 16, 1995,conform to at least one of the followinginterim safety standards: (1) TheAmerican National Standards Institute(ANSI) standard designated as Z90.4–1984, (2) the Snell MemorialFoundation standard designated as B–90, (3) the ASTM (formerly theAmerican Society for Testing andMaterials) standard designated as F1447, or (4) any other standard that theCommission determines is appropriate.15 U.S.C. 6004(a)–(b). On March 23,1995, the Commission published itsdetermination that five additionalvoluntary safety standards for bicyclehelmets are appropriate as interimmandatory standards. 60 FR 15,231.These standards are ASTM F 1447–1994; Snell B–90S, N–94, and B–95; andthe Canadian voluntary standard CAN/CSA–D113.2–M89. In that notice, theCommission also clarified that theASTM standard F 1447 referred to in theAct is the 1993 version of that standard.The interim standards are codified at 16CFR 1203.

The Act directed the ConsumerProduct Safety Commission to begin aproceeding under the AdministrativeProcedure Act, 5 U.S.C. 553, to:

a. Review the requirements of theinterim standards described above andestablish a final standard based on suchrequirements;

b. Include in the final standard aprovision to protect against the risk ofhelmets coming off the heads of bicycleriders;

c. Include in the final standardprovisions that address the risk of injuryto children; and

d. Include additional provisions asappropriate. 15 U.S.C. 6004(c).

The Act provides that the finalstandard shall take effect 1 year from thedate it is issued. 15 U.S.C. 6004(c). TheAct further provides that the finalstandard shall be considered to be aconsumer product safety standardissued under the CPSA. Section 9(g)(1)of the CPSA provides that a ‘‘consumerproduct safety standard shall beapplicable only to consumer productsmanufactured after the effective date.’’Thus, the final standard, which theCommission is issuing in this notice,will become effective March 10, 1999, asto products manufactured after thatdate. The Act also provides that failureto conform to an interim standard shallbe considered a violation of a consumerproduct safety standard issued underthe Consumer Product Safety Act(‘‘CPSA’’), 15 U.S.C. 2051–2084.

The Act states that the CPSA’sprovisions regarding rulemakingprocedures, statutory findings, andjudicial review (15 U.S.C. 2056, 2058,2060, and 2079(d)) shall not apply to thefinal standard or its rulemakingproceeding. 15 U.S.C. 6004(c).

The final rule is codified at 16 CFR1203 and will replace the interimstandards as to bicycle helmetsmanufactured on or after March 11,1999. 15 U.S.C. 6004(d). In addition, thefinal standard is also being designatedan interim standard, so that firms willhave the option of marketing helmetsmeeting CPSC’s final standard before itseffective date. Because providing thisadditional interim standard is asubstantive rule that grants anexemption or relieves a restriction, the30-day delay of an effective dateotherwise required by 5 U.S.C. 553(d) isinapplicable, and this designation iseffective March 10, 1998.

4. The Current Rulemaking ProceedingThe Commission reviewed the bicycle

helmet standards identified in the Act(ANSI, ASTM, and Snell), as well asinternational bicycle helmet standardsand draft revisions of the ANSI, ASTM,and Snell standards that were thenunder consideration. Based on thisreview, the Commission developed aproposed safety standard for bicycle

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11714 Federal Register / Vol. 63, No. 46 / Tuesday, March 10, 1998 / Rules and Regulations

9 Heh, S., Log of ASTM FO8.53 HeadgearSubcommittee meeting held May 21, 1992, date ofentry June 17, 1992. Office of the Secretary, U.S.Consumer Product Safety Commission, Washington,DC 20207.

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

The Commission received 37comments on that proposed bicyclehelmet standard from 30 individualsand organizations. After consideringthese comments and other availableinformation, the Commission proposedcertain revisions to the originallyproposed standard. 60 FR 62662(December 6, 1995).

In response to the second proposal,the Commission received 31 comments.These comments, and additional datathat have been received by theCommission since the second proposal,are discussed in Sections C–E of thisnotice.

B. Overall Description of the StandardThe major features of the standard

issued in this notice are describedbelow.

1. Impact AttenuationThe standard establishes a

performance test to ensure that helmetswill adequately protect the head in acollision. This test involves securing thehelmet on a headform and dropping thehelmet/headform assembly to achievespecified velocities so that the helmetimpacts a fixed steel anvil. The helmetmust provide protection at all pointsabove a line on the helmet that has aspecified relation to the headform.

Under the standard, the helmet istested with three types of anvils (flat,hemispherical, and ‘‘curbstone,’’ asshown in Figures 11, 12, and 13 of thestandard). These anvils represent shapesof surfaces that may be encountered inactual riding conditions.Instrumentation within the headformrecords the headform’s impact inmultiples of the acceleration due togravity (‘‘g’’). Impact tests are performedon different helmets, each of which hasbeen subjected to one of fourenvironmental conditions. Theseenvironments are: ambient (roomtemperature), high temperature (117–127°F), low temperature (1–9°F), andimmersion in water for 4–24 hours.

Impacts are specified on a flat anvilfrom a height of 2 meters and onhemispherical and curbstone anvilsfrom a height of 1.2 meters. Consistentwith the requirements of the ANSI,Snell, and ASTM standards, the peakheadform acceleration of any impactshall not exceed 300 g for an adulthelmet, the value originally proposedfor both adult and child helmets. In therevised proposed standard, theacceptable g value for children’shelmets was reduced to 250 g and alower headform drop mass than that foradults was specified (3.90 kg). As

explained in section C of this notice,however, the final rule specifies that the5-kg headform mass and the 300-g peakacceleration criterion will apply to allhelmets subject to the standard, asspecified in the original proposal.

The standard provides that a helmetfails the performance test if a failure canbe induced under any combination ofimpact site, anvil type, anvil impactorder, or conditioning environmentpermissible under the standard. Thus,the Commission will test for a ‘‘worstcase’’ combination of test parameters.What constitutes a worst case may vary,depending on the particular helmetinvolved.

2. Children’s Helmets: Head CoverageThe standard specifies that helmets

for small children (under age 5) mustcover a larger portion of the head thanmust helmets for older persons. A studyby Biokinetics & Associates Ltd. founddifferences in anthropometriccharacteristics between youngchildren’s heads and older children’sand adult’s heads.9

3. Retention SystemThe standard requires that helmets be

able to meet a test of the dynamicstrength of the retention system. Thistest ensures that the chin strap is strongenough to prevent breakage or excessiveelongation of the strap that could allowa helmet to come off during an accident.

The test requires that the chin strapremain intact and not elongate morethan 30 mm (1.2 in) when subjected toa ‘‘shock load’’ of a 4-kg (8.8-lb) weightfalling a distance of 0.6 m (2 ft) onto asteel stop anvil (see Figure 8). This testis performed on one helmet underambient conditions and on three otherhelmets after each is subjected to one ofthe different hot, cold, and wetenvironments.

4. Peripheral VisionSection 1203.14 of the standard

requires that a helmet shall allow a fieldof vision of 105 degrees to both the leftand right of straight ahead. Thisrequirement is consistent with theANSI, ASTM, and Snell standards.

5. Labels and InstructionsSection 1203.6 of the standard

requires certain labels on the helmet.These labels provide the modeldesignation and warnings regarding theprotective limitations of the helmet. Thelabels also provide instructions

regarding how to care for the helmet andwhat to do if the helmet receives animpact. The labels also must carry awarning that for maximum protectionthe helmet must be fitted and attachedproperly to the wearer’s head inaccordance with the manufacturer’sfitting instructions.

The standard also requires thathelmets be accompanied by fitting andpositioning instructions, including agraphic representation of properpositioning. As noted above, thestandard has performance criteria forthe effectiveness of the retention systemin keeping a helmet on the wearer’shead. However, these criteria may notbe effective if the helmet is not wellmatched to the wearer’s head andcarefully adjusted to obtain the best fit.

To avoid damaging the helmet bycontacting it with harmful commonsubstances, the helmet must be labeledwith any recommended cleaning agents,a list of any known common substancesthat will cause damage, and instructionsto avoid contact between suchsubstances and the helmet.

6. Positional Stability (Roll Off)The standard specifies a test

procedure and requirement for theretention system’s effectiveness inpreventing a helmet from ‘‘rolling off’’ ahead. The procedure specifies adynamic 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. Thisload is applied to the edge of a helmetthat is placed on a headform on asupport stand (see Figure 7). The helmetfails if it comes off the headform duringthe test.

The safety requirements discussed inparagraphs (1)–(6) above are issuedpursuant to the Bicycle Helmet SafetyAct and are codified as Subpart A of theSafety Standard for Bicycle Helmets.

7. Certification Labels and TestingProgram

Under the authority of section 14(a) ofthe CPSA, the Commission is alsoissuing certification testing and labelingrequirements to ensure that bicyclehelmets meet the standard’s safetyrequirements. These certificationrequirements are in Subpart B of theSafety Standard for Bicycle Helmets andare discussed in section D of this notice.

8. RecordkeepingUnder the authority of section 16(b) of

the CPSA, the Commission is issuingrequirements that manufacturers(including importers) maintain recordsof the required certification testing.These recordkeeping requirements arefound in Subpart C of the Safety

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11715Federal Register / Vol. 63, No. 46 / Tuesday, March 10, 1998 / Rules and Regulations

Standard for Bicycle Helmets and arediscussed in section E of this notice.

9. Interim Standards

The interim standards, which arecurrently codified as 16 CFR 1203, willcontinue to apply to bicycle helmetsmanufactured from March 16, 1995, toMarch 11, 1999. Accordingly, theinterim standards will continue to becodified, as Subpart D of the standard.Also, Subparts A–C of the standard arebeing added as an interim standard, sothat firms will have the option ofmarketing helmets meeting CPSC’s finalstandard before its effective date.

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

This section discusses comments onthe second proposal, as well as otherissues that were dealt with in decidingthe requirements of the final rule.Numbers in brackets refer to the numberassigned by the Commission’s Office ofthe Secretary to a comment on thesecond proposal.

1. Accident Scenarios

Mr. Frank Sabatano [14], President ofthe London Bridge BMX Association,recommended that bike helmets beconstructed so as to accommodate moreserious accidents that might result froma child bicycle racing or jumping ratherthan merely riding on a path or street.

While no helmet can protect againstevery conceivable impact, the availableevidence supports the conclusion thathelmets designed to meet the CPSCstandard will be very effective inprotecting against serious injury withina wide range of common bicycle ridingconditions. This would include many ofthe impact conditions that could occurduring racing or jumping. Furthermore,a standard for all bicycle helmets has tobalance the benefits of more protectivehelmets against the additional cost,weight, bulk, and discomfort that moreprotection may impose. Suchundesirable qualities may discouragemany users from wearing helmetsdesigned to protect against very severeimpacts, which could more than cancelthe effects of the additional protectivequalities. Thus, the force with which thehelmets are impacted in the standard’sperformance test has not been increased.

2. Future Revisions

Randy Swart, Director of the BicycleHelmet Safety Institute [16], suggestedthat the following items be consideredas future revisions to the CPSC standardas progress in head protection researchcontinues:

a. A test that requires the retentionsystem to be easily adjusted for good fit.

b. A test for protection againstrotational injury.

c. A test to limit localized loads or‘‘point loading.’’

d. A test for damage to the helmet byhair oil or other common consumerpreparations.

e. A test of the retention system afterimpact to simulate field conditions.

f. A test to ensure that visors andmirrors are shatter-resistant and easilypeel off in a crash.

The Commission agrees that it isimportant to periodically reviewresearch related to improvements inhead protection to determine ifrevisions should be considered for theCPSC bicycle helmet standard.

3. Compliance With Third-PartyStandards as Compliance With the Rule

Jane McCormack [7] requested thatthe Commission ensure that bikehelmets meet the Snell requirements.Norte Vista Medical Center [15]requested that helmets certified to theSnell B–95 or Snell N–94 standards beconsidered to be in compliance with themandatory standard.

The Commission declines to makethese changes. One of the objectives ofthe Bicycle Helmet Safety Act is toestablish a unified bicycle helmetstandard that is recognized nationallyby all manufacturers and consumers. Itwould defeat Congress’ intent to addlanguage to the regulation stating thatcertified conformance to any existingvoluntary standard satisfies compliancewith the mandatory rule.

4. Scope of the Standard

a. Definition of ‘‘Bicycle Helmet’’The original proposal defined bicycle

helmet as ‘‘any headgear marketed assuitable for providing protection fromhead injuries while riding a bicycle.’’The definition of bicycle helmet in thesecond proposal included not onlyproducts specifically marketed for useas a bicycle helmet but also thoseproducts that can be reasonably foreseento be used for that purpose.

Bell Sports [12] suggested that thedefinition of bicycle helmet should notinclude all products with a reasonablyforeseeable use as a device intended toprovide protection from head injurieswhile riding a bicycle. Bell maintainsthere are many helmets that have aforeseeable use by bike riders thatshould not have to be certified to a bikehelmet standard (e.g., baseball and rollerhockey helmets).

The respondent suggested thatfootball helmets, baseball battinghelmets, and motorcycle helmets willalso have ‘‘easily foreseeable’’ uses asbicycle helmets.

The Commission did not intend forthe definition of bicycle helmet toinclude football helmets, baseballbatting helmets, and motorcycle helmetsthat are not marketed for use whilebicycling. It seems unlikely that ahelmet that is not marketed or promotedfor bicycle use will have a reasonablyforeseeable use as a bicycle helmet.Thus, the ‘‘reasonably foreseeable’’language is unnecessary. Therefore, inorder for the definition to provide moreguidance, the ‘‘reasonably foreseeable’’language has been deleted, and thedefinition of bicycle helmet has beenchanged to read: ‘‘Bicycle helmet meansany headgear that either is specificallymarketed as, or implied throughmarketing or promotion to be, a deviceintended to provide protection fromhead injuries while riding a bicycle.’’

Helmets specifically marketed forexclusive use in a designated activitysuch as skateboarding, rollerblading,baseball, roller hockey, etc., would beexcluded from this definition becausethe specific focus of their marketingmakes it unlikely that such helmetswould be purchased for other than theirstated use. However, a multi-purposehelmet—one marketed or represented asproviding protection either duringgeneral use or in a variety of specificactivities other than bicycling—wouldfall within the definition of bicyclehelmet if a reasonable consumer couldconclude, based on the helmet’smarketing or representations, thatbicycling is among the activities inwhich the helmet is intended to beused.

In making this determination, theCommission will consider the types ofspecific activities, if any, for which thehelmet is marketed, the similarity of theappearance, design, and construction ofthe helmet to other helmets marketed orrecognized as bicycle helmets, and thepresence, prominence, and clarity ofany warnings, on the helmet or itspackaging or promotional materials,against the use of the helmet as a bicyclehelmet. The presence of warnings ordisclaimers advising against the use ofa multi-purpose helmet during bicyclingis a relevant, but not necessarilycontrolling, factor in the determinationof whether a multi-purpose helmet is abicycle helmet. A multi-purpose helmetmarketed without specific reference tothe activities in which the helmet is tobe used will be presumed to be a bicyclehelmet.

b. Multiple-Activity HelmetsSome commenters on the original

proposal recommended that the CPSCinclude provisions for children’s bicyclehelmets to provide protection in

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11716 Federal Register / Vol. 63, No. 46 / Tuesday, March 10, 1998 / Rules and Regulations

activities in addition to bicycling, suchas skateboarding, skating, sledding, andthe like. Two commentersrecommended that the CPSC bikehelmet standard also apply to helmetsmarketed for roller skating and in-lineskating. Other comments stated that theCommission should not delaypromulgation of the bike helmetstandard while multi-activity issues areexplored.

The Commission did not propose thatthe standard address activities otherthan bicycling, because the CPSC’sauthority under the Bicycle HelmetSafety Act is to set mandatoryrequirements for bicycle helmets.Establishing criteria for products otherthan bicycle helmets would require theCommission to follow the proceduresand make the findings prescribed by theCPSA or the Federal HazardousSubstances Act (‘‘FHSA’’).

The National Safe Kids Campaign(‘‘NSKC’’) [22] and the ConsumerFederation of America (‘‘CFA’’) [23]recognized that the scope of the CPSCstandard must be for bicycle helmets,but requested the Commission to moveforward in investigating the issuesrelated to multi-activity helmets. In acomment on the revised proposal, Mr.Frank Sabatano, President of theLondon Bridge BMX Association [14],recommended that bicycle helmetsshould serve as multi-purposeprotective devices for various sportssuch as bicycle riding, bicycle racing,skateboarding, and in-line skating.

The Commission intends to monitordevelopments relevant to the multi-activity issue. Wheeled recreationalactivities such as traditional rollerskating and in-line skating are typicallyconducted on the same surfaces asbicycling, and can generate speedssimilar to bicycling. Therefore, it isreasonable to assume that helmets thatmeet the requirements in the CPSC bikehelmet standard will also provide headprotection for roller/in-line skating andperhaps some other recreationalactivities. However, as discussed in theDecember 6, 1995, Federal Registernotice on the proposed rule, theCommission does not have sufficientdata on the benefits and costs ofadditional features directed at injuriesincurred in activities other thanbicycling to make the statutory findingsthat would be needed to issue arequirement for such features undereither the CPSA or FHSA. Also,procedures in addition to those requiredby the Bicycle Helmet Safety Act wouldhave to be followed. The Commissiondoes not want to delay establishment ofa mandatory bicycle helmet standard inorder to pursue rulemaking for other

types of helmets. Accordingly, the finalstandard only addresses requirementsfor bicycle helmets. However, asdiscussed below, the Commission willexamine what actions it could take toencourage the use of bicycle helmets inactivities that present head injury riskssimilar to those in bicycling.

NSKC [22] also urged the CPSC towork with community-basedorganizations to develop acomprehensive educational campaignregarding the importance of wearing afederally-approved bicycle helmet whenparticipating in non-motorized activitiesother than bicycling. The Commissionwill consider what activities areappropriate in this regard when settingits priorities for future activities.

5. ProjectionsProjections on the inner or outer

surface of a helmet can concentrateapplied forces and cause injuries.Therefore, the revised proposedstandard provided that projections onthe outer surface would not exceed 7mm (0.28 in) unless they break away orcollapse on impact and that projectionson the helmet’s interior not makecontact with the headform duringtesting.

NSKC [22] urged that the Commissionprohibit any external projections onhelmets intended for children. NSKCbelieves that external projections, suchas visors, are unnecessary componentsof helmets intended for children.

With regard to a possible hazard fromexternal projections on children’shelmets, § 1203.7 of the standardrequires that helmets must pass all tests,both with and without any attachmentsthat may be offered by the manufacturer.This provision, and the requirement thatany external projections shall breakaway or collapse, will address thepotential hazard of external projectionson helmets intended for riders of allages. The proposed language isconsistent with existing voluntarystandards, and no changes were made inresponse to this comment.

SwRI [2] remarked that the proposedstandard does not state how todetermine if an internal projectionmakes contact with the headform duringtesting. NSKC [22] also suggested thatinstead of requiring inner surfaceprojections to not exceed 2 mm, theinside of the helmet should contain nosharp edges or rigid internal projections.

After considering these comments, theCommission decided to revise thesection on internal projections toeliminate the requirement that internalprojections not make contact with theheadform during testing, while retainingthe requirement that such projection not

exceed 2 mm (0.08 in). The purpose ofthis section is to prohibit potentiallyhazardous projections but make someallowance for common helmetconstruction practices. The languageabove is consistent with Snell helmetstandards, and the Commission is notaware of safety problems associatedwith projections on helmets meetingexisting standards.

6. Requirements for Qualities of FittingPads

NSKC [22] urged the Commission toinclude safety requirements for fittingpads in the final standard. Thecommenter asserted that since fittingpads are often necessary to ensure asecure fit, the standard should addressthe integrity of the materials used toconstruct them, as well as theirthickness, durability, and adhesiveness.

CPSC staff has no information thatlong-term integrity of fitting pads is aproblem with helmets meeting existingstandards. The interim mandatorystandards have no provisions of the typesuggested by the commenter.Introducing new requirements for fittingpads is not essential at this time, and nochange to the proposed standard hasbeen made in response to this comment.

7. Impact Attenuation Criteria

a. Extent of Protection

The originally proposed CPSCstandard, and current U.S. voluntarybicycle helmet standards, specified anextent-of-protection boundary and animpact test line. The extent-of-protection boundary defines the area ofthe head that must be covered by thehelmet. The impact test line designatesthe lowest point on the helmet wherethe center of an anvil may be aligned fortesting. The second proposal specified asingle impact test line and no extent-of-protection boundary requirement. Notrequiring specific helmet coverageallows manufacturers the flexibility toinclude desirable features, such as acentral rear vent, provided the featuresdo not hinder the helmet’s ability tomeet the impact requirements if testedanywhere on or above the impact testline. Accordingly, the Commissiondeleted the extent-of-protectionboundary from the revised proposedstandard.

In commenting on the latter proposal,Snell [28] discussed the practicalproblems in certifying helmets whenonly an impact test line is specified.Snell recommended that the standard beamended to require coverage below theimpact test line, particularly at the frontand rear of a helmet.

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10 Dean Fisher and Terry Stern, ‘‘Helmets Work!,’’Bell Sports, Inc., AAAM/IRCOBI Conference, Lyon,France (September 1994).

11 Martin Williams, ‘‘Test Line Requirements andSnell B–95 and N–94 Standards,’’ TechnisearchEngineering & Scientific Services (August 1994).

The Commission disagrees with thiscomment. Coverage does not implyimpact protection. The only area on thehelmet required to pass impactprotection requirements is the areaabove the impact test line. Therefore, itis unnecessary to specify additionalcoverage below the test line.

The manufacturers of the ProtectiveHeadgear Manufacturing Association(‘‘PHMA’’) [29] reported that theybelieved the proposed CPSC standardrequires coverage at the rear of the headlower than any other standard. Theystated that they are not aware of anystudies indicating that lower coverage atthe rear is warranted. They also statedtheir concern that the helmet-wearingpublic will not purchase helmets thatare perceived to be more ‘‘clunky’’ or‘‘bulbous,’’ and that helmets withextended coverage are likely be soperceived. Mr. Becker of Snell [28]stated that the CPSC-proposed coveragesare more extensive than any currentU.S. standard, except for Snell’s B–95and N–94 helmet standards. He statedthat unless the CPSC coverage ischanged, many contemporary helmetmodels that have protected theirwearers from life-threatening injury willdisappear from the market. Snell urgedthat the CPSC adopt the coveragedescribed in the ASTM F1447–94 orSnell B–90 standards. According to thiscommenter, these coverages reflect thecurrent state of the industry and shouldbe expected of every bicycle helmet.

The proposed CPSC impact test line isnot lower at the rear of the helmet thanall other standards. The proposed CPSCimpact test line is somewhat lower atthe rear of the helmet than the impacttest lines in the Snell B–90 and ASTMF1447 standards. However, the CPSCline is higher at the rear of the helmetthan the impact test lines in thefollowing interim mandatory standards:Snell B–95 and N–94, CAN/CSA–D113.2, and ANSI Z90.4–1984.

CPSC is aware of two studies thatshow that it is not uncommon forhelmets involved in accidents to sufferimpacts at the rear portion of thehelmet. A Bell Sports study of 1100helmets involved in accidents foundthat 26% of the impacts were at the rearof the helmet and that the majority ofthese rear impacts occurred within 50mm of the bottom edge of the helmet.10

Another study, by Technisearch ofAustralia, examined the effect oflowering the impact test line from theSnell B–90 standard to the impact testlines in the Snell B–95 and N–94

standards.11 The Technisearch studywas based on examinations of 104bicycle helmets whose wearerssustained impacts to the head duringaccidents. The study concluded that theB–90 standard test line would haveprovided coverage for 51% of theimpacts. The impact test line of the B–95 standard would provide coverage for65% of the impacts. The increase from51% to 65% was represented by 20additional impact sites that would fallwithin the area of the B–95 coverage,including 8 impact sites at the rearportion of the helmet.

One of the directions of the Children’sBicycle Helmet Safety Act is to includeprovisions from existing appropriatestandards for adoption in the final CPSCstandard. The CPSC impact test line isa reasonable requirement that willimprove the protective characteristics ofhelmets overall, while falling within testlines of established North Americanbicycle helmet standards.

b. Distance Between Impacts

A commenter on the original proposalrecommended revising the minimumdistance between impact sites from theoriginally proposed ‘‘one fifth thecircumference of the helmet’’ to 120mm. The Commission believed that 120mm allows sufficient distance tominimize the effects of impact siteproximity and provides a morestraightforward measurement than theoriginal one-fifth circumference criteria.Accordingly, the Commission adoptedthis recommendation in the revisedproposal.

Two commenters on the revisedproposal [27 and 29] recommended aminimum distance between impacts of150 mm, or about 6 inches. One of thesecommenters stated that the CPSC madethe minimum distance shorter thanthose in voluntary standards.

The Commission selected the 120-mmimpact spacing based on recentlyballoted ASTM headgear standards. TheSnell B–95 standard also specifies aminimum impact separation of 120 mm.This distance is consistent with theSnell B–90 specification of 1⁄6th themaximum helmet circumference, ifcalculated for smaller helmets. Aminimum impact spacing of 150 mmwould limit flexibility in choosingimpact sites, especially on smallerhelmets. Therefore, no change to theproposed rule was made in response tothis comment.

c. Impact Velocity Tolerance

The University of SouthernCalifornia’s Head Protection ResearchLab (‘‘USC–HPRL’’) [8] suggested thatthe tolerance for the impact velocity bechanged from ±3% to ¥0% to +5% toensure that impact testing is done at noless than the specified velocity.

The difference between tolerances of±3% and ¥0%, +5% has little practicalsignificance for a 300–g criterion. Sincethe commenter’s suggestion would notproduce a significant safety benefit, theCommission made no change to theproposed rule in this regard.

d. Other Requirements for Children’sHelmets: Peak-G Value and Drop Mass

One of the provisions of TheChildren’s Bicycle Helmet Safety Act of1994 is that the Commission include inthe final CPSC standard provisions thataddress the risk of injury to children.This does not require that children’shelmets be subject to requirements thatdiffer from those for adults’ helmets; itrequires only that the final standard beappropriate for children’s helmets. Theissue of whether special standardprovisions for young children’s helmetsare needed has been debated for severalyears by head protection experts.

A young child’s skull has differentmechanical properties than the skull ofan older child or adult. Thesedifferences are especially evident forchildren under the age of 5 years. Theirskulls have a lower degree ofcalcification, making them more flexiblethan adult skulls. During an impact tothe head, the increased skull flexibilityresults in a greater transfer of kineticenergy from the impact site to the braintissue. Besides the different mechanicalproperties, the mass of a young child’shead is also different from that of a moremature person’s head. Studies show thatthe head mass of children under the ageof 5 years ranges from approximately 2.8to 3.9 kg. This mass is lower than the5-kg test headform mass specified incurrent U.S. bicycle helmet standards.

The Commission first proposed asafety standard for bicycle helmets onAugust 15, 1994. In that proposal, theonly special provision for helmets forchildren under 5 years was an increasedarea of head coverage. On December 6,1995, however, the Commissionproposed special provisions forheadform mass, peak-g limit, and headcoverage for bicycle helmets forchildren under 5 years. The specialchildren’s provisions were based on theongoing work of voluntary standardsorganizations and proposals at that timein the technical literature. The followingcomparison shows the CPSC-proposed

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12 Thompson, Robert S., MD; Rivara, Frederick P,MD, MPH; and Thompson, Diane C., MS ‘‘A CaseControl Study of the Effectiveness of Bicycle SafetyHelmets,’’ The New England Journal of Medicine320 [May 1989]: 1361–1367. Thompson, Diane C.,MS; Rivara, Frederick P, MD, MPH; and Thompson,Robert S., MD. ‘‘Effectiveness of Bicycle SafetyHelmets in Preventing Head Injuries,’’ Journal of theAmerican Medical Association 276 (December1996): 1968–1973.

13 Myers, Barry, M.D., Ph.D. ‘‘An Evaluation of AHelmet Standard for Children,’’ Report to the U.S.Consumer Product Safety Commission (July 1997).

test parameters for helmets for childrenunder 5 years and for helmets for olderpersons.

Under 5 5 andolder

Mass of testheadform.

3.9 kg ...................... 5.0 kg

Peak-g limit ... 250-g ...................... 300-gHead cov-

erage.More coverage at

rear and sides ofhead.

The proposal for increased headcoverage of children’s helmets isrelatively uncontroversial, and the finalrule contains this requirement.However, the Commission hasreassessed the proposed headform massand peak-g requirements. TheCommission’s conclusions are discussedin detail below.

A few respondents to the proposedrule [8, 16] supported the lower massand lower peak-g provisions, believingthat they will lead to an improvementin head protection for small children.One of these respondents, however,urged the Commission to consider themost recent research on this subjectbefore including the special provisionsin a final standard. One respondent [12]favored a reduced headform massprovision, but did not recommend areduced peak-g provision, stating that itcould result in a helmet with a lowermargin of safety.

Several respondents [3, 4, 6, 9, 10, 13,15, 18, 19, 27, 28, 29, 30] questionedwhether it is advisable to move forwardwith the provisions of a reduced-massheadform and a lower limit for peakacceleration. Some respondentssuggested that special children’sprovisions should not be adopted sincestudies show that children’s helmets asthey exist today provide excellentprotection.

Studies by researchers at theHarborview Injury Prevention andResearch Center have shown thatbicycle helmets that meet existingstandards are effective in protectingagainst serious head and braininjuries.12 One of the items analyzed inthe most recent Harborview study waswhether the protective effects of bicyclehelmets vary by the age of the user. Forfour age groups of riders, they estimatedthe protective effect of helmets against

three levels of injury listed in order ofincreasing severity: (1) head injury, (2)brain injury, and (3) severe brain injury.

Due to the small number of helmetedcase subjects that suffered brain injuryand severe brain injury, Harborviewresearchers could not estimate theprotective effect of helmets against theseinjuries for the under 6-year-old agegroup. Accordingly, the Commissionhas not relied on this study in itsconsideration of whether specialrequirements are needed for children’shelmets. However, one of Harborview’soverall conclusions was that helmets areeffective for all bicyclists, regardless ofage, and that there is no evidence thatchildren younger than 6 years need adifferent type of helmet.

The Commission requested technicalviews 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 modificationsof the standard should be consideredonly if it can be shown to improve theprotective qualities of helmets.Improvements may be shown byepidemiological or biomechanicalevidence. However, considering thedegree of head injury protectionprovided by current helmets,incremental improvement would bedifficult to detect, even with a largeepidemiological study.

From a biomechanical perspective, itis important to assess how changes intest headform mass and peak-g criteriawould affect helmet design andprotective capability. This can be doneby examining how a helmet functions toprotect the head in an impact.

The helmet has a crushable linertypically made of expanded polystyrenefoam. If the liner is crushed as the headpresses against the inside of the helmetduring impact, the liner allows the headto stop over a longer distance and timethan would otherwise be the case. Thisreduces the transfer of energy to thehead, thereby reducing the risk ofinjury.

The degree to which the liner resistsbeing crushed also affects the helmet’sprotective qualities. For a given impact,a helmet liner that is too soft will‘‘bottom out,’’ thereby losing itsprotective ability to allow relativemovement between the head and theobject being impacted. Conversely, aliner that is too hard will not allowsufficient crushing to adequately protectthe head.

Proponents of special provisions foryoung children’s helmets believe thatthese helmets should be tested underdifferent test parameters than helmetsintended for older persons. The currenttest parameters are based primarily onadult head injury tolerance and on aheadform mass that is approximatelythat of an adult head. Supporters ofspecial provisions contend that theseadult test parameters result in a helmetwith a liner that is too stiff to optimallyprotect a young child’s head. By usinga headform weight that better representsa young child’s head (e.g., 3.9 kg), andreducing the allowable peak-g, helmetswould need to be designed with a lowerdensity (‘‘less stiff’’) liner to furtherlessen the impact transmitted to thehead.

A simple way to examine the effect ofchanging headform mass and the peak-g criterion is to model the helmet as aspring and apply the one-dimensionalspring-mass impact formulas shownbelow. This approach is discussed byboth Dr. Myers and by Mr. Jim Sundahl,Senior Engineer with Bell Sports, in hisresponse to the proposed rule [12].

a Vok

m

x Vom

k

peak

peak

=

=

( )

( )

1

2

Where:apeak = peak acceleration (peak-g)Vo = impact velocityk = liner stiffnessm = headform massxpeak = required stopping distance (liner

thickness)If the value for headform mass m is

reduced in Equation (1), the value forliner stiffness k must be reduced toachieve the same peak-g at the sameimpact velocity. This means that if ahelmet that meets the standard’s criteriawith a 5-kg headform did not meet thepeak-g requirement using a lighterheadform, the helmet liner would needto be made softer so more crushing ofthe liner could occur.

If the value for peak acceleration apeak

is reduced in Equation (1), and the othervariables are held constant, the value forliner stiffness k again must be reduced.Thus, a helmet that could not complywith a reduced peak-g criterion alsowould need a softer liner to allow morecrushing. Equation (2) shows that, witha decreased liner stiffness, a greaterpercentage of the available crushdistance will be used during impact.

The biomechanical analysis showsthat, for impact conditions that do notresult in complete compression of the

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14 Rivara, Frederick P., MD, MPH, Thompson,Diane C., MS, Thompson, Robert S., MD‘‘Circumstances and Severity of Bicycle Injuries,’’Snell Memorial Foundation/Harborview InjuryPrevention and Research Center (1996).

helmet’s liner, it is possible to lessen theimpact energy transmitted to the head(and reduce the risk of injury) byreducing the stiffness of the liner.However as the impact energy increases,a helmet with a softer liner will bottomout (crush beyond its protectivecapacity) under less severe conditionsthan a helmet with a more rigid liner ofthe same thickness. To compensate, thesofter helmet would have to be madethicker to prevent bottoming out.However, there is a limit to how thicka helmet can be before it is no longerpractical or appealing to the user.Therefore, the goal of helmet design isto optimize liner density and thicknessto protect against the widest range ofimpact conditions and still have aproduct people will use.

The biomechanical analysis suggeststhat reducing the liner stiffness couldhave both a positive and a negativeinfluence on the protection provided byhelmets under existing criteria.Therefore, it is necessary to alsoexamine available epidemiological datathat relate to this issue. Decreasing theliner stiffness would benefit those whoexperience injuries with minimal or noliner deformation of current helmets.However, a decrease in liner stiffnesscould increase the number of headinjuries that occur during more severeimpacts that cause the helmet liner tobottom out.

To learn the effect on the level ofprotection offered by softer helmetliners for children under 5, twoquestions would need to be answered:

1. Are children suffering head injurieswith minimal or no deformation ofcurrent helmet liners?

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

Unfortunately, currently availableinformation does not answer either ofthese questions. Therefore, it isuncertain whether young childrenwould benefit from special provisionsfor headform mass and peak-g.

The only known study to examine therelationship between helmet damageand head injury was completed in 1996by the Snell Memorial Foundation andthe Harborview Injury Prevention andResearch Center.14 Of those bicyclehelmets collected from individuals (ofvarious ages) who went to a hospital,40% of the helmets had no deformation,14% had significant damage in whichthe helmet was approaching a bottomed-out condition, and 7% of the helmetshad catastrophic damage. The data were

not presented specifically for the under-5 age group or any other specific agegroup. The study showed that there wasa risk of head and brain injury evenwith no or minimal helmet damage. Therisk of injury increased moderately asthe severity of helmet damage increased,until catastrophic damage was reached.As expected, the risk of head and braininjury jumped dramatically when ahelmet was damaged catastrophically.This study suggests that if helmets forall ages were designed with softer liners,there is a potential to both improve theprotection for lower-severity impactsand increase the risk of injury at thehigher-severity impacts.

Since the risk of injury risesdramatically with catastrophic helmetdamage, and current helmets areeffective in reducing the risk of headand brain injuries, it would beimprudent to require softer helmetliners for bicyclists of all ages. Theavailable data are insufficient todetermine that such a change wouldincrease overall protection. Whenfocusing on the age range of under 5years, currently available information iseven more sparse. Therefore, if helmetsfor children under age 5 were madewith softer liners, there are insufficientdata to estimate either (1) the level ofprotection that might be gained at thelower-severity impacts or (2) theprotection that might be lost at thesevere impact conditions thatcompletely crush the liner.

For the reasons discussed above, theCommission did not include specialprovisions in the final standard forheadform mass and peak-g criteria foryoung children’s helmets. There areinsufficient data to justify the changes,and these changes could provide lessprotection in the most serious impacts.However, should future studies provideevidence that young children, orbicyclists of any age, could benefit fromdecreased liner stiffness, theCommission could consider revisions tothe bicycle helmet standard at that time.

8. Impact Attenuation Test Rig

a. Type of Test Rig

The originally proposed CPSCstandard and the current interimmandatory standards allowed the use ofeither a wire- or rail-guided impact testrig. In the revised proposal, theCommission specified only the monorailtest rig, to avoid the possibility thatdifferent results would be obtained withthe two types of test rigs.

Some helmet manufacturers [5, 29,30], and the Snell Memorial Foundation[28], disagreed with the specification ofthe monorail type of impact test rig.

Commenters stated that guidewire rigswere more widely used in the industry.Some commenters claimed that sincethere is no evidence that directlycorrelates monorail with guidewire rigresults, many firms would be forced tobuy monorail rigs to address liabilityconcerns. Trek [5] stated that the burdenof this expense may require additionalanalysis of the financial impact to smallbusiness, as required by the RegulatoryFlexibility Act. Snell wrote thatguidewire rigs have proven reliable,efficient, and highly repeatable. Theyare less expensive to install thanmonorail devices, and they are easier tomaintain. Snell stated that there is nodemonstrated improvement associatedwith the monorail rig in testingreliability and capability. Mostcommenters suggested that theCommission allow both monorail andguidewire rigs.

To respond to this issue, the CPSC’sstaff initiated a seven-laboratorycomparison test program. The mainpurpose of the study was to determineif there are statistically significant meandifferences in test results when usingmonorail and guidewire test rigs understandardized testing conditions.

Seven laboratories participated in thetest program, including the CPSC lab.Five of the laboratories tested on bothmonorail and guidewire rigs. Twolaboratories only tested on monorailrigs. Three different helmet models wereused. Each helmet was impacted twice,once at the rear of the helmet and oncenear the crown. Tests were conductedusing flat and curbstone anvils, and alltesting was performed with ambient-conditioned helmets. This experimentallowed the analysis of the effect of thefollowing variables: rig type, anvil type,helmet model, laboratory, anvil impactsequence, and impact location.

The statistical analysis of theinterlaboratory results showed that forthe majority of variable combinations,the choice of test rig did not have anappreciable effect on test results.However, on the Model I helmets, andonly when the second impact was onthe curbstone anvil, the monorailshowed a significantly higher meanlogarithm for peak-g readings summedacross laboratories having both types oftest rigs. For reasons completelyunrelated to these test results, acurbstone impact in combination withanother impact on any single test helmetis no longer permitted in the finalstandard. Since the interlaboratory data(summed across the laboratories thatused both types of test rigs) show nosignificant differences betweenguidewire and monorail rigs under testconditions within those allowed in the

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15 Although the draft ISO/DIS 6220–1983standard was never adopted as an internationalstandard, it has become a consensus nationalstandard because all recent major voluntarystandards used in the United States for testingbicycle helmets establish their headformdimensions by referring to the draft ISO standard.

final standard, the standard allowseither type of rig to be used for impactattenuation testing.

Over the last 15–20 years, voluntarystandards in the U.S. have allowed bothmonorail and guidewire types of testrigs. Both types of test rigs have beenused extensively in independent testlaboratories and in manufacturers’ in-house test facilities. The Snell MemorialFoundation, one of the establishedhelmet test organizations in the U.S.,uses guidewire rigs to test conformanceto their standards. The Commission hasno evidence that the allowance of bothtypes of test rigs in voluntary standardshas resulted in a compromise of safetyfor bicycle helmet users.

For the reasons discussed above, theCommission concludes that both typesof rigs are suitable for impactattenuation testing. Therefore, the finalCPSC standard specifies that either amonorail or a guidewire test rig may beused.

b. Accuracy Check

After evaluating the results of themulti-lab testing, the Commissionconcluded that the instrument systemcheck procedure should include aprocedure for calibrating the accuracy ofa test rig. Therefore, the final ruleincludes a precision and accuracyprocedure, so that laboratories canverify that their test equipment isrecording accurately. The procedurerequires that an aluminum sphere(spherical impactor) of a specifieddimension be dropped with a certainimpact velocity onto a ModularElastomer Programmer (MEP). A MEP isa cylindrical pad of polyurethane rubberthat is used as a consistent impactmedium for the systems checkprocedure. Pre-test and post-testimpacts on an MEP to verify systemrecording is a standard practice ofbicycle helmet test labs. All recordedimpacts must fall within the range of380 g to 425 g. In addition, thedifference between the high and lowvalues of the three recorded impactsmust not be greater than 20 g.

The range of 380 g to 425 g representsan allowable tolerance of about 10%.The interlaboratory testing showed thistolerance to be attainable betweenlaboratories. However, test experienceshows that even greater precision can beobtained for the systems checkprocedure within a given laboratory.The test data from the interlaboratorystudy show that a target range of 380 gto 425 g and a precision range of 20 gcan be achieved.

c. Test Headform CharacteristicsSwRI [#2] suggested that a more

appropriate value for the lower limit onthe resonant frequency of the headformmaterial should be 2000 hz instead of3000 hz.

The important conditions for the testheadforms are the material specificationand the dimensions defined by the draftISO/DIS 6220–1983 standard.15 Thisgoal is accomplished by stating that theheadforms shall be rigid and beconstructed of K–1A magnesium alloy.Test experience shows that headformsmeeting this description will not exhibitresonant frequencies that will interferewith proper data collection. Therefore,§ 1203.9 has been changed to deletereference to any lower limit onresonance frequencies. The proposalalso stated that another ‘‘functionallyequivalent’’ metal could be used as theheadform material. This alternative hasbeen eliminated in the final rule tospecify the headform apparatus asprecisely as possible and ensure againstthe use of materials that may influencethe test results.

Dr. Richard Snyder, President of theGeorge Snively Research Foundation[19], referenced two studies that relatedhelmet fit to head size and shape. Thefirst study was conducted by Dr. BruceBradtmiller of the AnthropometryResearch Project, Inc. Dr. Bradtmilleralso responded to the proposed rule[20]. He concluded that, for properchild-helmet sizing, head breadth andlength variables were more accurateguides than using age or headcircumference. Dr. Bradtmiller urgescaution in basing the CPSC’s rules forchildren’s helmets on the draft ISO DIS6220–1983 standard for test headforms.The study shows variation in the ratioof head length to head breadth. Thisratio was found to be the primedeterminant for helmet fit. The ISOstandard, however, maintains a constanthead breadth/length ratio. A secondstudy also concluded that headcircumference was not always a goodindicator for helmet fit.

ISO headforms are the establishednorm for headgear testing in the U.S.,Canada, Europe, and Australia. No othersystem of headforms is currentlyavailable that can be shown to preventmore injuries. Therefore, theCommission is retaining the ISOheadform specification in the finalCPSC standard. However, the

Commission’s staff will stay current ondevelopments of test procedures andequipment that could lead toimprovements in general helmet fit andin improvements that make it easier tofit and adjust helmets, especially forchildren.

d. Alignment of Anvils

The Commission amended§ 1203.17(a) to specify that the center ofthe anvil must be aligned with thecenter vertical axis of the accelerometer.This describes the already standardoperating procedure for bicycle helmettesting and is meant to preventimpacting helmets on the ‘‘corners’’ ofanvils.

e. Definition of ‘‘Spherical Impactor’’

SwRI [2] suggested that it is moreimportant to specify a 5-kg combineddrop mass for the spherical impactorand the drop assembly than to specifya 4-kg mass for the impactor itself.

The Commission has adopted thissuggestion. The more precisespecifications for a spherical impactorfor use as a system check device arenow in § 1203.17(b)(1), under thesystems check procedure.

9. Impact Attenuation Test Procedure

a. Anvil Test Schedule and Use ofCurbstone Anvil

Six respondents [5, 12, 27, 29, 30, and31] submitted comments requestingchanges to the test schedule in § 1203.13regarding the use of the curbstone anvil.All of the respondents expressedconcern over using two curbstoneimpacts on a single helmet. Asproposed, § 1203.3(d) and Table 1203.13did not define the conditions of thefourth impact on a helmet. The fourthimpact in the proposed standard wasleft to the discretion of test personnel,and thus could have been a secondcurbstone impact. One of thecommenters was also concerned aboutimpacting the helmet with the curbstoneanvil after the helmet was conditionedin a wet environment [12].

There also was concern about thecurbstone footprint overlapping otherimpact sites and violating the ‘‘singleimpact’’ principle of testing [27 and 31].The length of the curbstone anvilrestricts the location of impact sites thatcan be used without overlap. The use ofa second curbstone anvil, and thedamage caused by curbstone impacts,can restrict the selection of test sitesfurther, to the point where only threeimpacts without overlap may bepossible on a small helmet.

The Commission agrees that thepreviously proposed test schedule

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should be revised to prevent thepossibility of striking a test helmet withmore than one curbstone impact. Thepotential for overlapping ‘‘footprints’’ ofcurbstone impacts combined with otherimpacts on a single test helmet goesbeyond the intended principle of asingle impact for a given area. TheCommission disagrees, however, withthose commenters who recommendedthat only ambient-conditioned helmetsbe subjected to a curbstone impact. Toensure adequate protection againstimpact against curbstone-type shapes,tests for that anvil, as well as the othertest anvils, should be carried out in allof the environmental conditionsprescribed by the standard.Accordingly, revised § 1203.13 andTable 1203.13 contain a revised testschedule to incorporate a singlecurbstone impact on each of four‘‘clean’’ helmet samples, one from eachof the conditioning environments.

The Commission’s staff discoveredduring testing with the curbstone anvilthat severe physical damage—namelysplitting of the helmet from the impactpoint to the edge of the helmet—couldoccur even though the impact did notexceed the 300 g criterion. This led toconsideration of whether in such casesthe curbstone anvil test should berepeated on another sample to helpensure that other helmets will not failthis test.

The Commission acknowledges that,when marginal or unusual results occurin any of the standard’s tests, retestingmay be appropriate, even though the300-g criterion is not exceeded. Otherconditions that may prompt theCommission to undertake verificationtesting include (but are not limited to)peak-g readings that are very close to the300-g failure criterion. However, sincethe option of additional testinginherently exists, it is not necessary toinclude a provision requiring suchretesting in the standard.

b. Definition of ‘‘Comfort Padding’’The proposed definition of comfort

padding included the statement: ‘‘Thispadding has no significant effect onimpact attenuation.’’ SwRI [2]commented that fit padding may havesome influence on impactcharacteristics.

The Commission agrees with thiscommenter and deleted this statementfrom the definition.

c. Testing on More Than One HeadformIn the revised proposal, the standard

would have tested a helmet on all sizesof headform on which it fit. ‘‘Fit’’ wasobtained if it was not difficult to put thehelmet on the headform and the

helmet’s comfort or fit padding waspartially compressed.

PHMA [29] recommended that thesituation where more than oneheadform will ‘‘fit’’ a helmet should beaddressed by specifying the use of thelargest headform that will accommodatethe helmet, with comfort paddingadjusted to optimize the fit.

The Commission concludes that it isappropriate to simplify the testprocedure by testing on only one sizeheadform. This is consistent with thecurrent interim mandatory standards.However, in contrast to the commenter,the Commission believes that it is moreappropriate to test on the smallestheadform that is appropriate for the testsample. The Commission believes thatthe smaller headform will represent themore stringent test condition for thepositional stability test. Testing on onlyone size headform will lessen thenumber of test samples needed to testcompliance to the standard.

Therefore, a helmet shall be tested onthe smallest of the headformsappropriate for the helmet sample. Thissize headform is the smallest headformon which all of the helmet’s sizing padsare partially compressed when thehelmet is equipped with its thickestsizing pads and positioned correctly onthe reference headform.

Bell Sports [12] remarked that, wherea helmet will ‘‘fit’’ more than oneheadform size, choosing theconditioning environment for testing onthe larger headform(s) that produced thehighest g-value in the test on thesmallest headform that the helmet fitsdoes not necessarily provide the worstcase. The commenter recommended thatthere be four impacts in anyconditioning environment chosen by thetest technician. As explained above, theCommission is not going to test a givensize helmet on more than one headformsize. Accordingly, this comment is nolonger applicable.

d. Number of Helmets Required forTesting

Four respondents commented on thenumber of helmets required for testingwhen the helmet includes attachments,(e.g., removable visor, face shield) andpossible combinations of attachments[5, 12, 29, and 30]. They expressedconcern that the proposed standardrequires too many production helmetsamples to be tested. One respondent[12] offered suggested amending§ 1203.7(b) to include the statement that‘‘Helmets can be tested with anycombination of accessories.’’

Section 1203.7(a) of the proposedstandard requires helmets to be ‘‘testedin the condition in which they are

offered for sale.’’ Additionally, they arerequired to pass all tests both with andwithout any attachments that may beoffered. To adopt the suggested wordingwould not maintain the requirementthat helmets would meet the standardwith all combinations of accessories.However, the Commission agrees withthese commenters that it may beimpractical and unnecessary to specifyan additional set of eight test helmetsfor each added attachment and eachcombination of attachments in order totest for compliance with the standard.

To address this issue, the Commissiondecided to specify that attachmentsneed be tested only when they can affectthe test results, and that even then onlya ‘‘worst case’’ combination ofattachments need be tested. See thechanges to § 1203.7(b) and§ 1203.12(d)(1). For example, in the caseof a removable visor that has noinfluence on the retention systemstrength test, it would be unnecessary totest four helmets (one for eachconditioning environment) to that testwith the visor attached and anadditional four helmets without thevisor. However, it may be possible forattachments such as visors orfaceshields to influence tests such asimpact attenuation or peripheral vision.

10. Helmet Conditioning

a. Low-Temperature Environment:Temperature Range

SwRI [#2] commented that theallowable temperature range in the low-temperature environment shouldparallel the allowable temperatureranges in the other environments.

The Commission believes it is moreimportant for the low-temperatureenvironment range to be consistent withthe current interim standards than forthe range to parallel the toleranceallowed in the other environments.Thus, this comment was not adopted.However, the proposed temperaturerange contained a typographical error.The range should have been (¥17 to¥13 °C). This range is consistent withANSI, ASTM, Snell 95 and CSAstandards. This typographical error hasbeen corrected.

b. Water-Immersion Environment

Paula Romeo [26] suggested that thewater-immersion environment wasunrealistic and recommended a sprayconditioning environment.

Commission testing of both immersedand water-sprayed helmets undervarious time durations showed noconsistent trend in resulting peakacceleration levels. The immersionenvironment has the advantages of

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being easier to define and of subjectingthe helmet to a uniform conditioningexposure. Since testing showed thatthese commenters’ concerns wereunfounded, the immersion method ofwet-conditioning is retained.

c. Reconditioning Time

The revised proposed standardprovided that a helmet that wasremoved from its conditioningenvironment for more than 3 minutesbefore testing would be reconditionedfor 5 minutes for each minute beyondthe allotted 3 minutes before testingcould be resumed. SwRI [2] noted thatthere would be potentially no upperlimit to the exposure time to reconditiona helmet once it is removed from theconditioning environment for more than3 minutes.

The Commission agrees with thiscomment and has added a 4-hour limitto the reconditioning time in§ 1203.13(c).

11. Labels

a. Label Format and Content

Two respondents [22, 23] urged theCommission to require ‘‘an appropriatesymbol to appear adjacent to thestatement of compliance on the label’’and to add wording to warn that ‘‘failureto follow the warnings may result inserious injury or death.’’

The Commission agrees that moreemphasis should be placed on thewarning labels. Accordingly, the signalword ‘‘WARNING’’ is used with thewarnings required by § 1203.6(a)(2)–(5).See § 1203.6(a)(6). The Commissionconcludes that the signal word will bemore effective than a symbol, and thelimited size of the inside of a helmet,and the amount of information alreadyrequired on the labels, prevents the useof both a signal word and a symbol.

The limited space also prevents usingthe additional suggested language‘‘failure to follow the warnings mayresult in serious injury or death.’’ Inaddition, this language could possiblymislead some to conclude that properuse of a helmet will always preventserious injury or death. Accordingly, theCommission is not requiring a warningsymbol or the suggested language that‘‘failure to follow the warnings mayresult in serious injury or death.’’

b. Use Label

The proposed standard required alabel stating ‘‘Not for Motor VehicleUse.’’ Some comments addressed thischoice of language. [Comments 11, 13,22, 26.]

Two commenters stated that ‘‘Not forMotor Vehicle Use’’ wrongly suggested

the helmet was appropriate for any useother than motor vehicles. Anothercommenter felt that ‘‘Not for MotorVehicle Use’’ allows the helmet to beused for other activities similar tobicycle riding, where no alternativehelmet exists. A fourth commenterargued that ‘‘For Bicycle Use Only’’ wasa positive statement to which users aremore likely to respond.

On reconsideration, the Commissionconcludes that neither the ‘‘Not forMotor Vehicle Use’’ label nor the ‘‘ForBicycle Use Only’’ label adequatelyconveys the circumstances under whichhelmets that meet the CPSC standard areappropriate. It is reasonable to assumethat helmets that are certified to theCPSC standard will also provide headprotection for roller skaters, in-lineskaters, and, perhaps, some otherrecreational activities. In-line skatersshould not be discouraged from wearinga helmet by a label stating ‘‘For BicycleUse Only.’’

The Commission also believes thatconsumers understand both thedifferences between bicycle helmets andmotorcycle/motorsport helmets and thatbicycle helmets would not provideadequate protection for motorsportactivities. Therefore, the ‘‘Not for MotorVehicle Use’’ label is not a critical safetymessage that should be mandated in theCPSC standard. Therefore, the finalCPSC standard does not require a ‘‘use’’label, but maintains the requirement fora certification label that informs theconsumer that the helmet is certified tothe U.S. CPSC standard for bicyclehelmets.

c. Labeling for Cleaning Products

The second proposal required a labelwarning the user that the helmet can bedamaged by contact with commonsubstances (such as certain solvents,cleaners, etc.) and that this damage maynot be visible to the user. This label isalso required to state any recommendedcleaning agents and procedures, list anyknown common substances that damagethe helmet, and warn against contactingthe helmet with these substances.

Several respondents [2, 11, 12, 29]expressed concern that too muchinformation about cleaning productswould be needed on the label andargued that consumers should bedirected to the instruction manual forthe list of cleaning materials.

This label is not intended to list everypossible cleaning agent that can orshould not be used on the helmet. Sincethe consumer may not always have theowner’s manual, a label on the helmetshould provide some general cleaninginstructions and warnings. The language

of § 1203.6(a)(5) has been changed tomake this intent clear.

d. Warning To Replace After Impact[Commenters 22, 23, 26.] Some

respondents agreed with the proposedstandard’s provision that the label onthe helmet should advise consumers todestroy the helmet or return it to themanufacturer if it is involved in animpact. Others disagreed and requestedmore guidance on whether the helmet isimpaired before a consumer has toreturn the helmet.

The variety of factors (impact surface,impact location on helmet, impactspeed, etc.) that are involved in animpact to a helmet, and the level ofinteraction of each factor, are socomplex that it is inappropriate toaddress them in a label. It is to theconsumer’s overall safety benefit toreturn the helmet to the manufacturer ordestroy and replace it. Accordingly, theproposed replacement warning is notchanged.

e. Durability of LabelsSwRI [2] remarked that a requirement

for labels to be likely to remain legiblethroughout the life of the helmet cannotbe tested and could lead to differencesbetween laboratories. The PHMA [29]also expressed concern about thisrequirement, stating that it was unawareof any technology that will ensure thata sticker will stand up under 5 years ofthe type of exposure that a helmetreceives.

The Commission shares thesecommenters’ concerns. Currentvoluntary bicycle helmet standardsrequire ‘‘durable’’ labeling or labelingthat is ‘‘likely to remain legible for thelife of the helmet.’’ These conditions arenot quantified in current standards. TheCommission is not aware of any existingperformance test method that can beapplied in this circumstance. Since arequirement for legibility for the life ofthe helmet is vague and possiblyunattainable, the Commission haschanged the requirement to require‘‘durable’’ labels.

f. Labels on Both Helmets and BoxesThe American Society of Safety

Engineers (‘‘ASSE’’) [11] and the NSKC[22] suggested that ‘‘proper fit’’information should be on both thehelmet and the outside of the box.

The Commission does not believe it isnecessary to have the actual fittinginstructions on the box, because there isno information indicating that such alabel would be effective in assuringproper fit. However, it is important thatconsumers be aware that helmets docome in different sizes and that proper

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fit is important. A label on the boxpromoting the need for proper fit couldinform parents, before they buy thehelmet, that they need to properly fit thehelmet to the child. Therefore, the finalstandard applies § 1203.6(a)(3) to thehelmet’s packaging, as well as to thehelmet.

12. Instructions for Fitting Children’sHelmets

The NSKC [22] recommended that theproposed fitting instructions toaccompany children’s helmets be in age-specific language.

The Commission believes that age-specific instructions are unnecessary.The proposed standard requires both agraphic representation of properpositioning and written positioning andfitting directions. The graphics willreach more children than would age-specific instructions, because they allowchildren of all ages to compare the waytheir helmet looks with the pictures. Inaddition, graphics convey the criticalinformation to non-English-readingindividuals and illiterates. Children andadults are likely to be better able tounderstand and appreciate pictures thanage-specific instructions. This is morelikely to effectively deliver the message,allowing both parents and children tobecome aware of the proper fit.

13. Retention System Strength TestSwRI [2] asked whether both the peak

and residual displacements in the test ofthe dynamic strength of the retentionsystem should be measured in order tobetter describe the dynamics of thesystem.

Only the peak deflection reading isneeded to determine failure of theretention system. This is consistent withexisting U.S. bicycle helmet standards.Therefore, no change to the proposedrule was made in response to thiscomment.

USC–HPRL [8] suggested that theretention system test (§ 1203.13(d)) bedone after impact testing. Thecommenter reasons that an accident candamage a helmet and severelycompromise the retention system. Theretention system must ensure that thehelmet remain on the head during anaccident sequence.

After considering this comment, theCommission decided to make nochanges to the sequence for retentionsystem testing. Testing the retentionsystem prior to impact testing isconsistent with the ASTM and Snellstandards. The Commission has noevidence that the test sequence in theASTM and Snell standards allowshelmets that do not have adequateretention systems.

The commenter also recommends thatthe ‘‘zero’’ position for measuringelongation be established without theproposed step of pre-tensioning thestraps with a 4-kg mass.

There is no evidence that establishingthe ‘‘zero’’ position after pretensioningthe retention system, as proposed,would allow helmets that do not haveadequate retention systems to pass thetest. Therefore, the Commission madeno changes to the procedure forestablishing the pre-test ‘‘zero’’ position.

14. Positional Stability TestSwRI [2] remarked that the ASTM

Headgear Subcommittee is considering a7-kg preload to set the helmet duringtesting. SwRI also asked whether a thinrubber pad should be specified to softenhigh frequency impact noise.

Testing to support the development ofthe positional stability test was withequipment specified as proposed in theCPSC standard. Subsequent to initialASTM discussions about possiblerevisions to the proposed testprocedure, the ASTM F8 HeadgearSubcommittee decided not to modifythe pre-load and not to specify a rubberimpact pad. Therefore, the Commissionmade no change to this section.

NSKC [22] also recommends that theCommission examine the potentialinfluence that fitting pads may have onthe helmet’s ability to comply with theretention system requirements.

When testing for positional stability,the standard instructs testers to positionand fit the helmet on the test headformaccording to the manufacturer’sinstructions. This procedure mayinvolve changing the size and positionof the fit pads in order to achieve asecure fit. A similar procedure isfollowed to fit a bicycle helmet to theuser. Although fitting a helmet to ametal headform will not account for allof the human elements involved whenconsumers fit helmets to their heads, theproposed procedure is the mostpractical approach at this time andshould help keep the helmet secureduring an accident. Therefore, nochange to the proposed standard wasmade in response to this comment.

15. Vertical VisionOne commenter on the original

proposal suggested that the Commissionadopt requirements for a vertical field ofvision. The Commission declined to dothis because it had no information toindicate that bicycle helmets are posinga risk of injury due to inadequateupward or downward visual clearance.

In response to the second proposal,SwRI [2] suggested that requirements forvisual clearance at the brow be

considered and that this would beespecially important for racers who ridein the crouch position. However, a browclearance requirement might, in somecases, reduce the amount of headcoverage in the brow area. Further,CPSC has no information to indicatethat bicycle helmets meeting existingstandards are posing a risk of injury dueto inadequate ‘‘upward’’ visualclearance. Therefore, the Commissiondid not add a ‘‘brow’’ visual clearancerequirement to the final standard.

16. ReflectivitySome comments on the original

proposal related to possiblerequirements for helmets to improve abicyclist’s conspicuity in nighttimeconditions. Data do show an increasedrisk of injury while bicycling duringnon-daylight hours. The Commissionindicated that it would study this issuefurther in conjunction with plannedwork on evaluating the bicycle reflectorrequirements of CPSC’s mandatoryrequirements for bicycles. 16 CFR part1512. The Commission stated that itwould decide whether to proposereflectivity requirements for bicyclehelmets under the authority of theBicycle Helmet Safety Act after thatwork is completed.

Several commenters on the revisedproposal [1, 7, 11, 13, 16, 17, 22, 23, 24,26] urged that the Commission notpostpone implementing bicycle helmetreflectivity requirements.

Since the revised proposal, theCommission conducted field testing onbicycle reflectors and examined theissue of reflectivity on bicycle helmets.In the field testing, half (24/48) of thesubjects were tested using bicycle riderswith reflective helmets and the otherhalf were tested using riders wearingnon-reflective helmets. The reflectivetape used on the helmets met aproposed Standard on use ofRetroreflective Materials on BicycleHelmets that was balloted by the ASTMHeadgear Subcommittee. The studyfailed to show that the particular helmetreflective strip used in the study wouldincrease the distance at which a bicyclecan be detected or recognized(Schroeder, 1997). Accordingly, theCommission lacks data to support arequirement for bicycle helmetreflective performance.

17. Hard-shell RequirementsIn recommendations to the

Commission, Duke Universityresearcher Barry Myers M.D., Ph.D.,suggested that a test for penetrationresistance be considered for the finalstandard. He reasons that such a testwould require helmets to have hard

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16 Thompson, Diane C., MS; Rivara, Frederick P,MD, MPH; and Thompson, Robert S., MD.‘‘Effectiveness of Bicycle Safety Helmets inPreventing Head Injuries,’’ Journal of the AmericanMedical Association 276 (December 1996): 1968–1973.

17 Dean Fisher and Terry Stern, ‘‘Helmets Work!,’’Bell Sports, Inc., AAAM/IRCOBI Conference, Lyon,France (September 1994).

18 Voigt R. Hodgson, Ph.D., ‘‘Skid Tests on aSelect Group of Bicycle Helmets to Determine TheirHead-Neck Protective Characteristics,’’ Departmentof Neurosurgery, Wayne State University, Detroit,MI (March 8, 1991).

outer shells. Dr. Myers contends that ahard shell will reduce the risk ofpenetration-type traumas. He furthercontends that a hard shell will lessenfriction between the helmet and theimpact surface and that this has twobenefits. First, it would reduce the totalchange in velocity (∆V) of the headduring impact. Second, by reducing theforces on the head caused by frictionbetween the helmet and the impactsurface, it would reduce the risk of neckinjury.

In support of hard-shell helmets, Dr.Myers references the latestHarborview 16 study, which reported a‘‘consistent suggestion that hard-shellhelmets are more protective againsthead and brain injuries than non-hard-shell helmets.’’ Dr. Myers acknowledgesthat the differences measured were notstatistically significant. However, hebelieves that a larger study, containinga sufficient number of severe braininjuries, might show this correlationwith statistical significance.

In discussing protection against neckinjury, Dr. Myers notes that automotiveaccidents cause serious neck injuries inabout 15 to 25% of the persons whohave serious head injuries, suggestingthat neck injury is common among themost severely brain injured. However,since there were so few cases withsevere brain injuries in Harborview’sanalysis of bicycling incidents, thesignificance of neck injury, and itsmitigation by hard-shell helmets, amongthe severe brain injured cannot bedetermined from the Harborview study.

Although Dr. Myers suggests apenetration test in order to require thatbike helmets have a hard shell, he statesthat a detailed study of the most severeinjuries is warranted. He alsorecommends that, before a requirementthat all helmets have a hard shell isadopted, there should be an evaluationof whether this would reduce thenumber of riders who would wearbicycle helmets.

Currently available information doesnot show a need to address the hazardof penetration-type head impacts tobicyclists. One study 17 suggests that themajority of helmets involved in bicycleaccidents suffer impacts on flat, hardsurfaces (asphalt, cement, etc.) and thatpenetration-type impacts are rare.

Regarding the contention thatrequiring a hard shell may reduce neckinjuries, bicycle-related injury datashow a low incidence of serious neckinjuries. In 1996, there were 566,400bicycle-related injuries treated in U.S.hospital emergency rooms, based onCPSC data from NEISS. Of these, about6,630 (1%) involved the neck. Of theneck 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. Thesenumbers show that neck fracturesaccounted for about 0.04% of the totalnumber of emergency-room-treatedbicycle-related injuries in 1996. Detailedinformation was not available to analyzewhether the use of a helmet or type ofhelmet had an effect on the risk of neckinjury.

The Harborview study also reported alow incidence of neck injury. Theirreport showed that 2.7% of the cases(including both helmeted and non-helmeted cases) suffered neck injury,ranging from sprain to nerve-cordinjuries. There was no correlationbetween neck injury and helmet use orhelmet type.

Dr. Myers cites that automotiveaccidents cause serious neck injuries inabout 15 to 25% of the persons whohave serious head injuries. However,this statistic may not be relevant to theissue of friction between the shell andthe impact surface, since the neckinjuries in automotive accidents are notnecessarily caused by friction betweenthe head and an impacting surface.

Dr. Myers’ advocacy of hard-shellhelmets to reduce friction would seemto argue for a test to evaluate frictionresistance of a helmet against typicalimpact surfaces, rather than for apenetration-resistance test.

One study on this issue was done byVoigt Hodgson, Ph.D., at Wayne StateUniversity.18 In this study, test helmetswere secured to a modified Hybrid IIIdummy, and skid-type impacts weredone on concrete at various angles from30 to 60 degrees. Hodgson found thatboth hard-shell and micro-shell (or thin-shell) helmets tended to slide ratherthan ‘‘hang-up’’ on impact withconcrete. (Thin-shell helmets are thetype most commonly sold in the currentmarket). No-shell helmets showed alarger tendency to hang-up on impactswith concrete. One of the conclusions ofthe study was that any helmet similar to

those tested in the study (hard-, thin-, orno-shell) will protect the brain and neckmuch better than wearing no helmet.

Harborview reports that there was aconsistent trend indicating that hard-shell helmets provided better protectionagainst head and brain injury than non-hard-shell helmets. However, in orderfor the results to be statisticallysignificant, the number of people in thestudy would have had to be 11 timesgreater.

The Commission concludes that thefollowing considerations are relevant toany possible requirement for hard-shellbicycle helmets:

1. Studies of bicycle helmets damagedin accidents suggest that penetration-type helmet impacts are rareoccurrences. In addition, bicycle-relatedinjury data suggest a low incidence ofserious neck injuries. For the smallportion of incidents that involve seriousneck injury or penetration-type hazards,available information is insufficient toestimate the degree of improvedprotective performance that hard-shellhelmets may offer over non-hard-shellhelmets.

2. Non-hard-shell bicycle helmets areeffective in preventing serious head andbrain injuries. There are no knownstudies that report a statisticallysignificant finding that hard-shellhelmets offer better protection than non-hard-shell helmets.

3. A standard applying to all bicyclehelmets has to balance the protectivebenefit that might be provided by a hardshell against the additional cost, weight,bulk, and discomfort caused by such arequirement. Such undesirable qualitiesmay discourage some users fromwearing helmets, which could morethan cancel the effects of any additionalprotective qualities. This is anespecially important consideration,given the popularity of non-hard-shellbicycle helmets.

After considering these factors, theCommission concludes that theavailable information does not supportincluding a penetration test, or anyother test that would require all bikehelmets to have a hard shell, in the finalrule.

D. Certification Testing and Labeling

1. General

Section 14(a) of the CPSA, 15 U.S.C.2063(a), requires that everymanufacturer (including importers) andprivate labeler of a product that issubject to a consumer product safetystandard issue a certificate that theproduct conforms to the applicablestandard, and to base that certificateeither on a test of each product or on a

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‘‘reasonable testing program.’’Regulations implementing thesecertification requirements are codifiedin Subpart B of the Safety Standard forBicycle Helmets.

2. The Certification RuleThe proposed certification rule would

require manufacturers of bicyclehelmets that are manufactured after thefinal standard becomes effective to affixpermanent labels to the helmets statingthat the helmet complies with theapplicable U.S. CPSC standard. Theselabels would be the ‘‘certificates ofcompliance,’’ as that term is used in§ 14(a) of the CPSA.

In some instances, the label on thebicycle helmet may not be immediatelyvisible to the ultimate purchaser of thehelmet prior to purchase because ofpackaging or other marketing practices.In those cases, the final rule requires anidentical second label on the helmet’spackage or, if the package is notvisible—as when the item is sold froma catalog, for example—on thepromotional material used inconnection with the sale of the bicyclehelmet.

The certification label also containsthe name, address, and telephonenumber of the manufacturer or importer,and identifies the production lot and themonth and year the product wasmanufactured. Some of the requiredinformation may be in code.

The certification rule requires eachmanufacturer or importer to conduct areasonable testing program todemonstrate that its bicycle helmetscomply with the standard. Thisreasonable testing program may bedefined by the manufacturer orimporter, but must include either thetests prescribed in the standard or anyother reasonable test procedures thatassure compliance with the standard.

The certification rule provides thatthe required testing program will testbicycle helmets sampled from eachproduction lot so that there is areasonable assurance that, if the bicyclehelmets selected for testing meet thestandard, all bicycle helmets in the lotwill meet the standard.

The rule provides that bicycle helmetimporters may rely in good faith on theforeign manufacturer’s certificate ofcompliance, provided that a reasonabletesting program has been performed byor for the foreign manufacturer and theimporter is a U.S. resident or has aresident agent in the U.S.

3. Reasonable Testing ProgramProposed § 1203.33(b)(4) stated that if

the reasonable testing program ‘‘showsthat a bicycle helmet may not comply

with one or more requirements of thestandard, no bicycle helmet in theproduction lot can be certified ascomplying until all noncomplyinghelmets in the lot have been identifiedand destroyed or altered * * * to makethem conform to the standard.’’ TrekUSA [5] commented that the proposedlanguage describing a reasonable testingprogram was restrictive because itimplies that if a single helmet fails anyaspect of the test procedure, all of theproduct in the lot cannot be certifieduntil corrective action is taken. Thecommenter suggested a change in thewording of § 1203.33(b)(4) from ‘‘abicycle helmet’’ to ‘‘any bicycle helmet’’that fails to conform to the testingcriteria. The commenter asserts that thischange would provide more flexibility,as it would remove the possibility of ananomaly in the testing causing a lack ofcertification of an entire lot.

The Commission did not make therequested change in the wording of§ 1203.33(b)(4). First, it does not appearthat the requested language wouldchange the meaning of this requirement.Second, the purpose of the testingprogram is to detect possible failures ofbicycle helmets in a production lot andto reasonably ensure that the helmetsthat are certified comply with thestandard. The Commission intends thatfailure of one helmet would trigger aninvestigation to determine whether thefailure extends to other helmets in theproduction lot. That investigationshould continue until it is reasonablylikely that no noncomplying helmetsremain in the production lot. Thewording of § 1203.33(b)(4) has beenchanged to make this intent clear.

a. Changes in Materials or VendorsThe proposed standard provides that

when there are changes in parts,suppliers, or production methods, a newproduction lot should be established forthe purposes of certification testing. ThePHMA [29] wants clarification of whenthere are material or vendor changes.PHMA requests that the Commissionuse the Safety Equipment Institute(‘‘SEI’’) guidance to help firmsunderstand the terms material changes,design changes, and vendor changes.

The Commission does not think thatestablishing definitions as stated in theSEI ‘‘Definition of Term’’ would add anysignificant clarification for the industryas a whole. Each firm can institute itsown testing program, as long as thetesting program is reasonable. Theintent of the regulation is to ensure thatall firms establish a reasonable testingprogram and to provide flexibility forboth large and small firms. Each firmhas the flexibility to define its own

terms in its quality control program,including material changes, designchanges, and vendor changes, as long asthe testing program is effective andreasonably able to determine whetherall bicycle helmets comply with thestandard. The Commission made norevision to the proposed rule inresponse to this comment. However,manufacturers and importers shouldkeep records describing the testingprogram and explaining why theprogram is sufficient to reasonablydetermine that all of the firm’s bicyclehelmets comply with the standard.Similarly, when the testing programdetects noncomplying helmets, the firmshould record the actions taken andwhy those actions are sufficient toreasonably ensure that nononcomplying helmets remain in theproduction lot. See Subpart C of Part1203.

b. Pre-market Clearance and MarketSurveillance

The Snell Memorial Foundation [28]and Paul H. Appel [25] propose theadoption of the pre-market clearanceand market surveillance provisions ofthe Snell standard to ensure that qualitybicycle helmets are produced.According to the commenters, withoutthese two Snell provisions, Governmentefforts will be insufficient to keepinadequate helmets off the market.

All firms must ensure that bicyclehelmets sold in the United States arecertified to the mandatory bicyclehelmet standard, and that thecertifications are based on reasonabletesting programs. Firms that distributenoncomplying products are subject tovarious Commission enforcementactions. These actions include recall,injunctions, seizure of the product, andcivil or criminal penalties. The penaltiesfor such violations could subject a firmto penalties of up to $1.5 million and,after notice of noncompliance, fines ofup to $50,000 or imprisonment ofindividuals for not more than 1 year, orboth.

The Commission has statutoryauthority to inspect manufacturers,importers, distributors, and retailers ofbicycle helmets. This authority includesthe right to review and copy recordsrelevant to compliance with the bicyclehelmet standard. The Commission mayalso collect samples of bicycle helmetsfor testing to the standard.

The Commission has a vigorousenforcement program that includes jointimport surveillance with U.S. Customsand compliance surveillance ofdomestic producers, distributors, andretailers. In addition, the staff responds

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to all reports of noncompliance with allmandatory standards.

From previous history with otherregulations that the Commissionenforces, compliance with the variousCPSC standards is high. In addition, allfirms have a responsibility to reportnoncompliance with the standard underSection 15(b) of the Consumer ProductSafety Act. 15 U.S.C. 2064(b). Failure toreport could subject a firm to severepenalties.

Based on these considerations, theagency’s enforcement programs andenforcement authority will providesubstantial assurance that bicyclehelmets will meet the requirements forthe mandatory standard. Experience inenforcing other CPSC regulations hasshown that a high degree of compliancecan be achieved without manufacturersusing a pre-market clearance program ora third-party certifying organization.Therefore, the Commission made norevision to the proposed rule inresponse to this comment.

4. Certificate of Compliance

a. Coding of Date of Manufacture

The proposed standard required thecertification label to contain the monthand year of manufacture, but allowedthis information to be in code. Mr. L.E.Oldendorf, P.E., from ASSE[11], theBicycle Helmet Safety Institute (‘‘BHSI’’)[16], the Bicycle Federation ofWisconsin [24], and Paula Romeo [26]opposed allowing manufacturers to codethe month and year of manufacture.These commenters felt that uncodeddates would help consumers determinewhether their helmet was subject to arecall. One commenter stated that anuncoded production date is necessary toassist consumers when they wish toreplace their helmet after 5 years.

As the commenters noted, an uncodedmanufacture date would make it easierfor consumers to tell when their helmetsare subject to a recall. This informationalso would help users determine whenthe helmet’s useful life is over and thehelmet should be replaced. Snell helmetstandards require that the manufacturedate be uncoded, and it is already acommon practice in the industry.Accordingly, the Commission hasrevised the standard to require anuncoded date of manufacture.

b. Telephone Number on Label

Two commenters [23 and 26] urgedthat the Commission require labelsshowing the manufacturer’s telephonenumber. They stated that thisrequirement would make it easier forthe consumer to contact themanufacturer about recall information

and about instructions for returning thehelmet to the manufacturer after it hasbeen damaged.

The telephone number would behelpful for consumers during a recall orto inquire about a damaged bicyclehelmet because they could determinethe status of their helmets quicker thanby a written inquiry. Obtaining aquicker response would enable theconsumer to replace a defective helmetsooner and thus reduce the possibilityof injuries caused by having an accidentwhile wearing a defective helmet.Therefore, the Commission is requiringthe telephone number of the U.S.manufacturer or importer on thehelmet’s labeling.

c. Certification Label on Children’sHelmets

PHMA [29] suggested that a labelshowing certification for children under5 is needed on the packaging, but is notneeded inside the helmet.

The Commission does not agree.Since helmets for small children arelikely to be shared with or passed on tomultiple users, the sticker on the helmetis likely to be the only source ofinformation available to the second orthird user. Further, it is common todisplay helmets at retail without thebox. Thus, the purchaser may not seethe box until after selecting the model,if at all. Therefore, this labeling will berequired on both the box and thehelmet.

d. Minimum Age on Labels forChildren’s Helmets

Section 14(a) of the CPSA requiresthat certifying firms issue a certificatecertifying that the product conforms toall applicable consumer product safetystandards. 15 U.S.C. 2063(a).Accordingly, the original proposalwould have required the label statement‘‘Complies with CPSC Safety Standardfor Bicycle Helmets (16 CFR part1203)’’. This was changed in the revisedproposal because the Commissionwanted to guard against the possibilitythat small adult helmets will bepurchased for children. Therefore, therevised proposed standard required thathelmets that do not comply with therequirements for young children’shelmets would be labeled ‘‘Complieswith CPSC Safety Standard for BicycleHelmets for Adults and Children Age 5and Older (16 CFR 1203)’’. Under thatproposal, helmets intended for children4 years of age and younger would beara label stating ‘‘Complies with CPSCSafety Standard for Bicycle Helmets forChildren Under 5 Years (16 CFR 1203)’’.That proposal further provided thathelmets that comply with both

standards could be labeled ‘‘Complieswith the CPSC Safety Standard forBicycle Helmets for Persons of AllAges’’, or equivalent language.

Maurice Keenan, MD, from theAmerican Academy of Pediatrics [21],requested that a minimum age of 1 yearbe reflected on the label for helmetsintended for children under age 5. Thiswould better convey the message thatinfants (children under age 1) shouldnot be passengers on a bicycle underany circumstance.

The Commission agrees with thecommenter that children under 1 year ofage should not be on bicycles. Childrenare just learning to sit unsupported atabout 9 months of age. Until this age,infants have not developed sufficientbone mass and muscle tone to enablethem to sit unsupported with theirbacks straight. Pediatricians adviseagainst having infants sitting in aslumped or curled position forprolonged periods. This position mayeven be exacerbated by the addedweight of a bicycle helmet on theinfant’s head. Because pediatriciansrecommend against having childrenunder age 1 as passengers on bicycles,the Commission does not want thecertification label to imply that childrenunder age 1 can ride safely. Thus, theproposed language that a helmetcomplies with CPSC’s standard ‘‘forChildren Under 5 Years’’ or ‘‘for personsof all ages’’ is not suitable, since thesephrases include children less than 1year old.

Further, the only difference betweenthe final requirements for helmets forchildren of ages 1–4 and for helmets forolder persons is that the youngchildren’s helmets cover more of thehead. Therefore, children’s helmets willinherently comply with therequirements for helmets for olderpersons, and the label need not indicatean upper cutoff of age 5 for meetingCPSC’s requirements.

For the reasons given above, theproposed label indicating that helmetscomply with the standard for helmetsfor children under 5 years has beenamended to state that the helmetscomply with the CPSC standard for‘‘persons age 1 and older.’’

e. Identifying the Commission

The NSKC [22] encouraged theCommission to modify the certificationlabeling to require the language ‘‘UnitedStates Consumer Product SafetyCommission’’ rather than ‘‘CPSC.’’ Thecommenter believes that the acronym islikely to lead to consumer confusion,but that the use of the full name of theCommission will clearly identify the

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helmet as meeting a federal safetystandard.

The rationale presented by thecommenter for using the full name ofthe Commission instead of using theacronym is logical. However, the use ofthe Commission’s full name may beimpractical for some manufacturers. Theamount of space available on the insideof a helmet is limited. The proposedregulation requires a number of labels,and each one is supposed to be legibleand easily visible to the user. Allowingthe use of the acronym is a necessarycompromise so that all the labels can beaccommodated on the inside of thehelmet. However, the Commissionconcluded that the acronym shouldinclude the designation ‘‘U.S.’’ before‘‘CPSC’’ to indicate that the standard isissued by an agency of the FederalGovernment. Further, the Commissionbelieves manufacturers should have thechoice of whether to use the acronym orspell out the agency’s name.Accordingly, the following wording hasbeen added to §§ 1203.34(b)(1) and1203.34(d): ‘‘this label may spell out‘U.S. Consumer Product SafetyCommission’ instead of ‘U.S. CPSC’.’’

f. Certification Label on PackagingThe proposed standard provided that

the certification compliance label shallalso be on the helmets’ packaging orpromotional material if the label is notimmediately visible on the product.NSKC [22] requested that the finalstandard require that such package labelbe legible and prominent, and placed onthe main display panel of the packagingso that it is easily visible to thepurchaser.

The Commission agrees with thecommenter and has added the followingwording to § 1203.34(d): ‘‘The labelshall be legible, readily visible, andplaced on the main display panel of thepackaging or, if the packaging is notvisible before purchase (e.g., catalogsales), on the promotional material usedwith the sale of the bicycle helmet.’’

E. Recordkeeping

1. IntroductionSection 16(b) of the CPSA requires

that:Every person who is a manufacturer,

private labeler, or distributor of a consumerproduct shall establish and maintain suchrecords, make such reports, and provide suchinformation as the Commission mayreasonably require for the purposes ofimplementing this Act, or to determinecompliance with rules or orders prescribedunder this Act.

15 U.S.C. 2065(b)The rule requires every entity issuing

certificates of compliance for bicycle

helmets to maintain records that showthe certificates are based on a reasonabletesting program. These records wereproposed to be maintained for a periodof at least 3 years from the date ofcertification of the last bicycle helmet ineach production lot and to be availableto any designated officer or employee ofthe Commission upon request inaccordance with § 16(b) of the CPSA, 15U.S.C. 2065(b).

2. Location of Test Records

The original proposal required thatrecords be kept by the importer in theU.S. to allow inspection by CPSC staffwithin 48 hours of a request by anemployee of the Commission. Inresponse to a comment on the originalproposal, the Commission revised theregulation to state that if the importercan provide the records to the CPSCstaff within the 48-hour time period, therecords will be considered kept in theU.S.

SwRI [2] commented that the 48-hourallowance to provide test records to theCommission should apply to allmanufacturers or importers, whether ornot the test records are maintainedwithin the U.S.

The Commission agrees with thiscomment, and the final rule providesthat all firms are required to providerecords for immediate inspection andcopying upon request by a Commissionemployee. If the records are notphysically available during theinspection because they are maintainedat another location, the firm mustprovide them to the staff within 48hours.

3. Length of Records Retention

Paula Romeo [26] raised the issue ofwhether certification records should bemaintained for longer than 3 years,since helmets can be used for 5 years.

The purpose of records being kept for3 years is to ensure that the helmetshave time to clear the distributionchannels and get into the marketplace.If there is a compliance problem ordefect in the helmets, 3 years would besufficient to uncover any problems withthe helmets. The Commission’s staffwould have time to obtain the recordsto review the firm’s testing program andtake any necessary enforcement actionduring this 3-year period. Therefore, nochange was made in the rule in responseto this comment.

F. Regulatory Flexibility ActCertification

Introduction

When an agency undertakes arulemaking proceeding, the Regulatory

Flexibility Act, 5 U.S.C. 601 et seq.,generally requires the agency to prepareinitial and final regulatory flexibilityanalyses describing the impact of therule on small businesses and other smallentities.

The purpose of the RegulatoryFlexibility Act, as stated in § 2(b) (5U.S.C. 602 note), is to require agencies,consistent with their objectives, to fitthe requirements of regulations to thescale of the businesses, organizations,and governmental jurisdictions subjectto the regulations. The RegulatoryFlexibility Act provides that an agencyis not required to prepare a regulatoryflexibility analysis if the head of anagency certifies that the rule will nothave a significant economic impact ona substantial number of small entities. 5U.S.C. 605.

The Commission’s Previous EconomicFindings

In the August 1994 notice of proposedrulemaking, the Commission noted thatany costs associated with designchanges to comply with the originalproposal would be spread out over thecourse of production, and would besmall on a per-unit basis. Costsassociated with testing and monitoringwere not expected to increase, since thevast majority of firms already used thirdparties to test for conformance to thevoluntary standards. The proposal alsoallowed for self-certification and self-monitoring which, for some companies,may be substantially less costly thanthird-party certification. The proposedlabeling requirements were not expectedto have a significant impact on smallfirms, in that virtually all helmetsalready bore a similar label. Based onthis information, the Commissionpreliminarily concluded that theproposal would not have a significantimpact on a substantial number of smallentities. The Commission received nopublic comment on this conclusion.

As a result of non-economiccomments of a technical nature, theCommission proposed a revisedstandard on December 6, 1995. In thatnotice, the Commission reiterated itsassessment of the economic impact ofthe standard on small businesses. In thepreamble to the 1995 proposal, theCommission again preliminarilycertified that the proposed standard, ifpromulgated, would not have asignificant economic effect on asubstantial number of small entities.

Current Economic Assessment andResponse to Comments

The Commission’s Directorate forEconomics prepared an economicassessment of the safety standard for

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bicycle helmets. The vast majority ofhelmets now sold conform to one (ormore) of three existing voluntarystandards. Many of these helmetsprobably already comply with theimpact attenuation requirements of thenew rule. On a per-unit basis, costsassociated with redesign and testing areexpected to be small.

The standard’s labeling requirementsare unlikely to have a significant impacton firms, since virtually all bicyclehelmets now bear a permanent label ontheir inside surface. Industry sourcesreport that, given sufficient lead time tomodify these labels, any increased costof labeling would be insignificant.

The vast majority of manufacturersnow use third-party testing andmonitoring for product liability reasons,and are likely to continue to do so in thefuture. The standard allows for self-certification and self-monitoring,however, which is substantially lesscostly than third-party testing andmonitoring.

The Commission received twocomments on the 1995 proposal thatrelated to the economic effects of therevision. These involved the costassociated with the specification of amonorail test device, and the effect ofthe curbstone testing procedure.

A comment from Trek BicycleCorporation [5] approved specifying asingle test apparatus, but was concernedthat the Commission chose a monorail-guided test rig over a guidewire unit.Trek said that the majority of PHMAmembers test on wire-guided equipmentand that some firms may be forced topurchase monorail units to eliminateproduct liability concerns. The firmstated, ‘‘[t]he burden of this unnecessaryexpense may provide need foradditional analysis of the financialimpact to small business, as required bythe Regulatory Flexibility Act.’’

Based on contacts with industry andtesting facilities, it appears that, of thosemanufacturers that have in-house testlabs, an estimated 5 to 10 have only awire-guided rig. Most commercial,independent, and academic bicyclehelmet test labs have a monorail test rig,and many of those labs also have one ormore wire-guided rigs. The estimatedcost to purchase a monorail-guided rigis about $20,000.

An interlaboratory study comparingthe results of monorail and guidewiretest rigs showed no significantdifferences between the two types ofrigs in test conditions that are withinthe parameters permitted by the draftstandard. Therefore, the final standardhas been revised to specify that either amonorail or a guidewire apparatus maybe used to test a helmet’s impact

attenuation performance. Consequently,the potential cost considerations forlaboratories using guidewire rigs nolonger apply.

Another commenter, Bell Sports [12],noted that the proposal also includedimpact testing requirements thatallowed two impacts with a devicesimulating helmet contact with a curb.Bell estimated that ‘‘[t]he addition of thecurbstone anvil * * * and with theoption of using it twice on any helmetmight well increase the retail price ofbicycle helmets by $2.00 to $10.00.’’

The standard is intended to addresshelmet safety from a single impact on agiven area. For this reason, the impacttesting requirement has been changed torequire only a single curbstone impactsimulation test per helmet test sample.Consequently, the potential changes inhelmet design that could have beenneeded to comply with two curbstoneimpact tests no longer apply.

Small Business EffectsOf the 30 current manufacturers of

bicycle helmets, all but two would beconsidered small businesses underSmall Business Administrationemployment criteria (less than 100employees). As the Commission foundpreviously, the one-time costs of designare expected to be small on a per-unitbasis.

Spokesmen for the PHMA estimatethat there are 1,000 to 1,500 bicycle-helmet molds in current use, each ofwhich contains 4 molding cavities.Redesign may be required for one ormore cavities in some molds, whileother molds may not require any cavityredesign. Using a midpoint estimate of1,250 molds, there would be some 5,000cavities in current use in helmet molds.

The PHMA estimates that the top 4manufacturers of bicycle helmetsaccount for about 700 molds (or some2,800 cavities) used in helmetproduction. The other 26 firms accountfor the remainder or, on average, 21molds per firm (84 cavities). The PHMAestimates that 10% or less of theexisting cavities would require redesignin order for the helmets made by themto comply with the standard. Thus,smaller firms may need to redesign anaverage of 8.4 cavities. Each cavity costsapproximately $2,500, according to thetrade association. On average, the one-time cost of cavity redesign for thesmaller 26 firms would be about$21,000 each.

The top 4 firms account for anestimated 75% of the 9 million helmetssold annually, according to PHMA. Theremaining firms thus account for 25%,or 2.25 million helmets annually. Ifsales are allocated uniformly, each of

the 26 firms would account for about87,000 units. If spread over a singleyear’s production, the average cavityredesign cost would be about 24 centsper helmet.

Further, the industry routinelyreplaces molds (and, thus, cavities),either because of style changes inhelmet designs or because they wearout. The above estimates, however,assume that no molds would have beenreplaced absent the standard. Becausethe standard will not become effectiveuntil 1 year after the final rule ispublished, some of the noncomplyingcavities may be replaced in that interimfor reasons independent of the finalstandard. Consequently, the estimatedone-time costs associated with thereplacement of the smaller firms’ moldcavities that would be attributed solelyto the standard are likely to besignificantly less than $21,000 each.

Regulatory Flexibility CertificationBecause the per-unit costs of

modifying production molds will berelatively low, the Commissionconcludes that the rule will not have asignificant impact on a substantialnumber of small entities.

G. Environmental ConsiderationsPursuant to the National

Environmental Policy Act, and inaccordance with the Council onEnvironmental Quality regulations andCPSC procedures for environmentalreview, the Commission assessed thepossible environmental effectsassociated with the safety standard forbicycle helmets.

The Commission’s regulations, at 16CFR 1021.5(c) (1) and (2), state thatsafety standards and product labeling orcertification rules for consumerproducts normally have little or nopotential for affecting the humanenvironment. The analysis of thepotential impact of this rule indicatesthat the rule is not expected to affectpreexisting packaging or materials ofconstruction now used bymanufacturers. Existing inventories offinished products would not berendered unusable, since § 9(g)(1) of theCPSA provides that standards applyonly to products manufactured after theeffective date. Changes in coverage areasfor helmets may require modification orreplacement of existing injection molds.Industry experts estimate that there aresome 1,000 to 1,500 molds currentlyused by bicycle helmet producers, andthat perhaps 10% are likely to beaffected by the proposed standard.Molds are constructed of aluminum,commonly weighing 40–50 poundseach. Molds are also routinely replaced

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due to wear or to changes in style.Helmet manufacturers send these oldermolds back to the firm makingreplacements, and the older units aremelted down for use in the replacementmolds. Thus, the quantity of discardsresulting from the rule is likely to besmall.

Especially in view of the statutory 1-year effective date, it is unlikely thatsignificant stocks of current labels willrequire disposal.

The requirements of the standard arenot expected to have a significant effecton the materials used in production orpackaging, or on the amount ofmaterials discarded due to theregulation. Therefore, no significantenvironmental effects are expected fromthis rule. Accordingly, neither anenvironmental assessment nor anenvironmental impact statement isrequired.

H. Paperwork Reduction ActAs noted above, U.S. manufacturers

and importers of bicycle helmets will berequired to conduct a reasonable testingprogram to ensure their productscomply with the standard. They willalso be required to keep records of suchtesting so that the Commission’s staffcan verify that the testing wasconducted properly. This will enablethe staff to obtain information indicatingthat a company’s helmets comply withthe standard, without having itself totest helmets. U.S. manufacturers andimporters of bicycle helmets will alsohave to label their products withspecified information.

The rule thus contains ‘‘collection ofinformation requirements’’ subject tothe Paperwork Reduction Act of 1995,15 U.S.C. 3501–3520, Pub. L. No. 104–13, 109 Stat. 163 (1995). An agency maynot conduct or sponsor, and a person isnot required to respond to, a collectionof information unless it displays acurrently valid OMB control number.The control number may be displayedby publication in the Federal Register.Accordingly, the Commission submittedthe proposed collection of informationrequirements to OMB for review undersection 3507(d) of the PaperworkReduction Act of 1995.

The Commission’s staff estimates thatthere are about 30 manufacturers andimporters subject to these collection ofinformation requirements. There are anestimated 200 different models ofbicycle helmets currently marketed inthe U.S.

Industry sources advised theCommission’s staff that the time thatwill be required to comply with thecollection of information requirementswill be from 100 to 150 hours per model

per year. Therefore, the total amount oftime required for compliance with theserequirements will be 20,000 to 30,000hours per year. However, theseestimates are based on the amount oftime that is currently expended incomplying with the similarrequirements that are in the variousvoluntary standards. Thus, theadditional burden of the final collectionof information requirements is expectedto be only a small fraction of the totalhours given above.

The Commission solicited commentson the activities and time required tocomply with these requirements andhow these differ from usual andcustomary current industry practices, onthe accuracy of the Commission’sburden estimate, and on how thatburden could be reduced. No commentsdirectly addressed the Commission’sburden estimate. Comments addressingthe topic of reducing the number ofhelmets required to be tested under thestandard are discussed in section C ofthis notice.

I. Executive Orders

This rule has been evaluated forfederalism implications in accordancewith Executive Order No. 12,612, andthe rule raises no substantial federalismconcerns.

Executive Order No. 12,988 requiresagencies to state the preemptive effect,if any, to be given to the regulation. Thepreemptive effect of this rule isestablished by 15 U.S.C. 2075(a), whichstates:

(a) Whenever a consumer product safetystandard under [the CPSA] is in effect andapplies to a risk of injury associated with aconsumer product, no State or politicalsubdivision of a State shall have anyauthority either to establish or to continue ineffect any provision of a safety standard orregulation which prescribed anyrequirements as to the performance,composition, contents, design, finish,construction, packaging, or labeling of suchproduct which are designed to deal with thesame risk of injury associated with suchconsumer product, unless such requirementsare identical to the requirements of theFederal standard.

Subsection (b) of 15 U.S.C. 2075provides that subsection (a) does notprevent the Federal Government or thegovernment of any State or politicalsubdivision of a State from establishingor continuing in effect a safety standardapplicable to a consumer product for itsown (governmental) use, and which isnot identical to the consumer productsafety standard applicable to theproduct under the CPSA, if the Federal,State, or political subdivisionrequirement provides a higher degree of

protection from such risk of injury thanthe consumer product safety standard.

Subsection (c) of 15 U.S.C. 2075authorizes a State or a politicalsubdivision of a State to request anexemption from the preemptive effect ofa consumer product safety standard.The Commission may grant such arequest, by rule, where the State orpolitical subdivision standard orregulation (1) provides a significantlyhigher degree of protection from suchrisk of injury than the consumer productsafety standard and (2) does not undulyburden interstate commerce.

List of Subjects in 16 CFR Part 1203Consumer protection, Bicycles,

Incorporation by reference, Infants andchildren, Safety.

For the reasons given above, theCommission revises Part 1203 of Title16 of the Code of Federal Regulations toread as follows:

PART 1203—SAFETY STANDARD FORBICYCLE HELMETS

Subpart A—The StandardSec.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—Recordkeeping1203.40 Effective date.1203.41 Recordkeeping requirements.

Subpart D—Requirements for BicycleHelmets Manufactured From March 17,1995, Through March 10, 19991203.51 Purpose and basis.1203.52 Scope and effective date.1203.53 Interim safety standards.

Figures to Part 1203Authority: 15 U.S.C. 2056, 2058, and 6001–

6006. Subpart B is also issued under 15

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1 Although the draft ISO/DIS 6220–1983 standardwas never adopted as an international standard, ithas become a consensus national standard becauseall recent major voluntary standards used in theUnited States for testing bicycle helmets establishtheir headform dimensions by referring to the draftISO standard.

1 Helmets specifically marketed for exclusive usein a designated activity, such as skateboarding,rollerblading, baseball, roller hockey, etc., would beexcluded from this definition because the specificfocus of their marketing makes it unlikely that suchhelmets would be purchased for other than theirstated use. However, a multi-purpose helmet—onemarketed or represented as providing protectioneither during general use or in a variety of specificactivities other than bicycling—would fall withinthe definition of bicycle helmet if a reasonableconsumer could conclude, based on the helmet’smarketing or representations, that bicycling isamong the activities in which the helmet isintended to be used. In making this determination,the Commission will consider the types of specificactivities, if any, for which the helmet is marketed,the similarity of the appearance, design, andconstruction of the helmet to other helmetsmarketed or recognized as bicycle helmets, and thepresence, prominence, and clarity of any warnings,on the helmet or its packaging or promotionalmaterials, against the use of the helmet as a bicyclehelmet. A multi-purpose helmet marketed withoutspecific reference to the activities in which thehelmet is to be used will be presumed to be abicycle helmet. The presence of warnings ordisclaimers advising against the use of a multi-purpose helmet during bicycling is a relevant, butnot necessarily controlling, factor in thedetermination of whether a multi-purpose helmet isa bicycle helmet.

U.S.C. 2063. Subpart C is also issued under15 U.S.C. 2065.

Subpart A—The Standard

§ 1203.1 Scope, general requirements, andeffective date.

(a) Scope. The standard in thissubpart describes test methods anddefines minimum performance criteriafor all bicycle helmets, as defined in§ 1203.4(b).

(b) General requirements.(1) Projections. All projections on

bicycle helmets must meet theconstruction requirements of § 1203.5.

(2) Labeling and instructions. Allbicycle helmets must have the labelingand instructions required by § 1203.6.

(3) Performance tests. All bicyclehelmets must be capable of meeting theperipheral vision, positional stability,dynamic strength of retention system,and impact-attenuation tests describedin §§ 1203.7 through 1203.17.

(4) Units. The values stated inInternational System of Units (‘‘SI’’)measurements are the standard. Theinch-pound values stated in parenthesesare for information only.

(c) Effective date. The standard shallbecome effective March 10, 1999 andshall apply to all bicycle helmetsmanufactured after that date. Bicyclehelmets manufactured from March 17,1995 through March 10, 1999, inclusive,are subject to the requirements ofSubpart D, rather than this subpart A.

§ 1203.2 Purpose and basis.The purpose and basis of this

standard is to reduce the likelihood ofserious injury and death to bicyclistsresulting from impacts to the head,pursuant to 15 U.S.C. 6001–6006.

§ 1203.3 Referenced documents.(a) The following documents are

incorporated by reference in thisstandard.

(1) Draft ISO/DIS Standard 6220–1983—Headforms for Use in the Testingof Protective Helmets.1

(2) SAE Recommended Practice SAEJ211 OCT88, Instrumentation for ImpactTests.

(b) This incorporation by referencewas approved by the Director of theFederal Register in accordance with 5U.S.C. 552(a) and 1 CFR Part 51. Copiesof the standards may be obtained asfollows. Copies of the draft ISO/DISStandard 6220–1983 are available from

American National Standards Institute,11 W. 42nd St., 13th Floor, New York,NY 10036. Copies of the SAERecommended Practice SAE J211OCT88, Instrumentation for ImpactTests, are available from Society ofAutomotive Engineers, 400Commonwealth Dr., Warrendale, PA15096. Copies may be inspected at theOffice of the Secretary, ConsumerProduct Safety Commission, 4330 East-West Highway, Bethesda, Maryland20814, or at the Office of the FederalRegister, 800 N. Capitol Street NW,Room 700, Washington, DC.

§ 1203.4 Definitions(a) Basic plane means an anatomical

plane that includes the auditorymeatuses (the external ear openings)and the inferior orbital rims (the bottomedges of the eye sockets). The ISOheadforms are marked with a planecorresponding to this basic plane (seeFigures 1 and 2 of this part).

(b) Bicycle helmet means anyheadgear that either is marketed as, orimplied through marketing orpromotion to be, a device intended toprovide protection from head injurieswhile riding a bicycle.2

(c) Comfort or fit padding meansresilient lining material used toconfigure the helmet for a range ofdifferent head sizes.

(d) Coronal plane is an anatomicalplane perpendicular to both the basicand midsagittal planes and containingthe midpoint of a line connecting theright and left auditory meatuses. TheISO headforms are marked with atransverse plane corresponding to this

coronal plane (see Figures 1 and 2 ofthis part).

(e) Field of vision is the angle ofperipheral vision allowed by the helmetwhen positioned on the referenceheadform.

(f) Helmet positioning index (‘‘HPI’’)is the vertical distance from the brow ofthe helmet to the reference plane, whenplaced on a reference headform. Thisvertical distance shall be specified bythe manufacturer for each size of eachmodel of the manufacturer’s helmets, forthe appropriate size of headform foreach helmet, as described in § 1203.10.

(g) Midsagittal plane is an anatomicalplane perpendicular to the basic planeand containing the midpoint of the lineconnecting the notches of the right andleft inferior orbital ridges and themidpoint of the line connecting thesuperior rims of the right and leftauditory meatuses. The ISO headformsare marked with a longitudinal planecorresponding to the midsagittal plane(see Figures 1 and 2 of this part).

(h) Modular elastomer programmer(‘‘MEP’’) is a cylindrical pad, typicallyconsisting of a polyurethane rubber,used as a consistent impact medium forthe systems check procedure. The MEPshall be 152 mm (6 in) in diameter, and25 mm (1 in) thick and shall have adurometer of 60 ± 2 Shore A. The MEPshall be affixed to the top surface of aflat 6.35 mm (1⁄4 in) thick aluminumplate. See § 1203.17(b)(1).

(i) Preload ballast is a ‘‘bean bag’’filled with lead shot that is placed onthe helmet to secure its position on theheadform. The mass of the preloadballast is 5 kg (11 lb).

(j) Projection is any part of the helmet,internal or external, that extends beyondthe faired surface.

(k) Reference headform is a headformused as a measuring device andcontoured in the same configuration asone of the test headforms A, E, J, M, andO defined in draft ISO DIS 6220–1983.The reference headform shall includesurface markings corresponding to thebasic, coronal, midsagittal, andreference planes (see Figures 1 and 2 ofthis part).

(l) Reference plane is a plane markedon the ISO headforms at a specifieddistance above and parallel to the basicplane (see Figure 3 of this part).

(m) Retention system is the completeassembly that secures the helmet in astable position on the wearer’s head.

(n) Shield means optional equipmentfor helmets that is used in place ofgoggles to protect the eyes.

(o) Spherical impactor is an impactfixture used in the instrument systemcheck of § 1203.17(b)(1) to test theimpact-attenuation test equipment for

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precision and accuracy. The sphericalimpactor shall be a 146 mm (5.75 in)diameter aluminum sphere mounted onthe ball-arm connector of the dropassembly. The total mass of thespherical-impactor drop assembly shallbe 5.0 ± 0.1 kg (11.0 ± 0.22 lb).

(p) Test headform is a solid model inthe shape of a human head of sizes A,E, J, M, and O as defined in draft ISO/DIS 6220–1983. Headforms used for theimpact-attenuation test shall beconstructed of low-resonance K–1Amagnesium alloy. The test headformsshall include surface markingscorresponding to the basic, coronal,midsagittal, and reference planes (seeFigure 2 of this part).

(q) Test region is the area of thehelmet, on and above a specified impacttest line, that is subject to impacttesting.

§ 1203.5 Construction requirements—projections.

Any unfaired projection extendingmore than 7 mm (0.28 in.) from thehelmet’s outer surface shall break awayor collapse when impacted with forcesequivalent to those produced by theapplicable impact-attenuation tests in§ 1203.17 of this standard. There shallbe no fixture on the helmet’s innersurface projecting more than 2 mm intothe helmet interior.

§ 1203.6 Labeling and instructions.(a) Labeling. Each helmet shall be

marked with durable labeling so that thefollowing information is legible andeasily visible to the user:

(1) Model designation.(2) A warning to the user that no

helmet can protect against all possibleimpacts and that serious injury or deathcould occur.

(3) A warning on both the helmet andthe packaging that for maximumprotection the helmet must be fitted andattached properly to the wearer’s headin accordance with the manufacturer’sfitting instructions.

(4) A warning to the user that thehelmet may, after receiving an impact,be damaged to the point that it is nolonger adequate to protect the headagainst further impacts, and that thisdamage may not be visible to the user.This label shall also state that a helmetthat has sustained an impact should bereturned to the manufacturer forinspection, or be destroyed andreplaced.

(5) A warning to the user that thehelmet can be damaged by contact withcommon substances (for example,certain solvents [ammonia], cleaners[bleach], etc.), and that this damage maynot be visible to the user. This label

shall state in generic terms somerecommended cleaning agents andprocedures (for example, wipe withmild soap and water), list the mostcommon substances that damage thehelmet, warn against contacting thehelmet with these substances, and referusers to the instruction manual for morespecific care and cleaning information.

(6) Signal word. The labels requiredby paragraphs (a) (2) through (5) of thissection shall include the signal word‘‘WARNING’’ at the beginning of eachstatement, unless two or more of thestatements appear together on the samelabel. In that case, the signal word needonly appear once, at the beginning ofthe warnings. The signal word‘‘WARNING’’ shall be in all capitalletters, bold print, and a type size equalto or greater than the other text on thelabel.

(b) Instructions. Each helmet shallhave fitting and positioninginstructions, including a graphicrepresentation of proper positioning.

§ 1203.7 Samples for testing.(a) General. Helmets shall be tested in

the condition in which they are offeredfor sale. To meet the standard, thehelmets must be able to pass all tests,both with and without any attachmentsthat may be offered by the helmet’smanufacturer and with all possiblecombinations of such attachments.

(b) Number of samples. To testconformance to this standard, eightsamples of each helmet size for eachhelmet model offered for sale arerequired.

§ 1203.8 Conditioning environments.Helmets shall be conditioned to one

of the following environments prior totesting in accordance with the testschedule at § 1203.13. The barometricpressure in all conditioningenvironments shall be 75 to 110 kPa(22.2 to 32.6 in of Hg). All test helmetsshall be stabilized within the ambientcondition for at least 4 hours prior tofurther conditioning and testing. Storageor shipment within this ambient rangesatisfies this requirement.

(a) Ambient condition. The ambientcondition of the test laboratory shall bewithin 17°C to 27°C (63°F to 81°F), and20 to 80% relative humidity. Theambient test helmet does not needfurther conditioning.

(b) Low temperature. The helmet shallbe kept at a temperature of ¥17°C to¥13°C (1°F to 9°F) for 4 to 24 hoursprior to testing.

(c) High temperature. The helmetshall be kept at a temperature of 47°Cto 53°C (117°F to 127°F) for 4 to 24hours prior to testing.

(d) Water immersion. The helmetshall be fully immersed ‘‘crown’’ downin potable water at a temperature of17°C to 27°C (63°F to 81°F) to a crowndepth of 305 mm ± 25 mm (12 in. ± 1in.) for 4 to 24 hours prior to testing.

§ 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 § 1203.10.Headforms used for impact testing shallbe rigid and be constructed of low-resonance K–1A magnesium alloy.

§ 1203.10 Selecting the test headform.A helmet shall be tested on the

smallest of the headforms appropriatefor the helmet sample. A headform sizeis appropriate for a helmet if all of thehelmet’s sizing pads are partiallycompressed when the helmet isequipped with its thickest sizing padsand positioned correctly on thereference headform.

§ 1203.11 Marking the impact test line.Prior to testing, the impact test line

shall be determined for each helmet inthe following manner.

(a) Position the helmet on theappropriate headform as specified bythe manufacturer’s helmet positioningindex (HPI), with the brow parallel tothe basic plane. Place a 5-kg (11-lb)preload ballast on top of the helmet toset the comfort or fit padding.

(b) Draw the impact test line on theouter surface of the helmet coincidingwith the intersection of the surface ofthe helmet with the impact line planesdefined from the reference headform asshown in:

(1) Figure 4 of this part for helmetsintended only for persons 5 years of ageand older.

(2) Figure 5 of this part for helmetsintended for persons age 1 and older.

(c) The center of the impact sites shallbe selected at any point on the helmeton or above the impact test line.

§ 1203.12 Test requirements.(a) Peripheral vision. All bicycle

helmets shall allow unobstructed visionthrough a minimum of 105° to the leftand right sides of the midsagittal planewhen measured in accordance with§ 1203.14 of this standard.

(b) Positional stability. No bicyclehelmet shall come off of the testheadform when tested in accordancewith § 1203.15 of this standard.

(c) Dynamic strength of retentionsystem. All bicycle helmets shall have aretention system that will remain intactwithout elongating more than 30 mm(1.2 in.) when tested in accordance with§ 1203.16 of this standard.

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(d) Impact attenuation criteria.(1) General. A helmet fails the impact

attenuation performance test of thisstandard if a failure under paragraph(d)(2) of this section can be inducedunder any combination of impact site,anvil type, anvil impact order, orconditioning environment permissibleunder the standard, either with orwithout any attachments, orcombinations of attachments, that areprovided with the helmet. Thus, theCommission will test for a ‘‘worst case’’combination of test parameters. Whatconstitutes a worst case may vary,depending on the particular helmetinvolved.

(2) Peak acceleration. The peakacceleration of any impact shall notexceed 300 g when the helmet is testedin accordance with § 1203.17 of thisstandard.

§ 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 inaccordance with § 1203.14 of thisstandard.

(b) Helmet samples 1 through 8, asdesignated in Table 1203.13, shall beconditioned in the ambient, hightemperature, low temperature, andwater immersion environments asfollows: helmets 1 and 5—ambient;helmets 2 and 7—high temperature;helmets 3 and 6—low temperature; andhelmets 4 and 8—water immersion.

(c) Testing must begin within 2minutes after the helmet is removedfrom the conditioning environment. Thehelmet shall be returned to theconditioning environment within 3minutes after it was removed, and shallremain in the conditioning environmentfor a minimum of 2 minutes beforetesting is resumed. If the helmet is outof the conditioning environment beyond3 minutes, testing shall not resume untilthe helmet has been reconditioned for aperiod equal to at least 5 minutes for

each minute the helmet was out of theconditioning environment beyond thefirst 3 minutes, or for 4 hours,(whichever reconditioning time isshorter) before testing is resumed.

(d) Prior to being tested for impactattenuation, helmets 1–4 (conditionedin ambient, high temperature, lowtemperature, and water immersionenvironments, respectively) shall betested in accordance with the dynamicretention system strength test at§ 1203.16. Helmets 1–4 shall then betested in accordance with the impactattenuation tests on the flat andhemispherical anvils in accordance withthe procedure at § 1203.17. Helmet 5(ambient-conditioned) shall be tested inaccordance with the positional stabilitytests at § 1203.15 prior to impact testing.Helmets 5–8 shall then be tested inaccordance with the impact attenuationtests on the curbstone anvil inaccordance with § 1203.17. Table1203.13 summarizes the test schedule.

TABLE 1203.13.—TEST SCHEDULE

§ 1203.14Peripheral

vision

§ 1203.15Positionalstability

§ 1203.16Retention

systemstrength

§ 1203.17 Impact tests

Anvil Number ofImpacts

Helmet 1, Ambient ...................................................................................... X .................... X X Flat .......X Hemi ....

22

Helmet 2, High Temperature ...................................................................... .................... .................... X X Flat .......X Hemi ....

22

Helmet 3, Low Temperature ....................................................................... .................... .................... X X Flat .......X Hemi ....

22

Helmet 4, Water Immersion ........................................................................ .................... .................... X X Flat .......X Hemi ....

22

Helmet 5, Ambient ...................................................................................... .................... X .................... X Curb ..... 1Helmet 6, Low Temperature ....................................................................... .................... .................... .................... X Curb ..... 1Helmet 7, High Temperature ...................................................................... .................... .................... .................... X Curb ..... 1Helmet 8, Water Immersion ........................................................................ .................... .................... .................... X Curb ..... 1

§ 1203.14 Peripheral vision test.

Position the helmet on a referenceheadform in accordance with the HPIand place a 5-kg (11-lb) preload ballaston top of the helmet to set the comfortor fit padding. (Note: Peripheral visionclearance may be determined when thehelmet is positioned for marking the testlines.) Peripheral vision is measuredhorizontally from each side of themidsagittal plane around the point K(see Figure 6 of this part). Point K islocated on the front surface of thereference headform at the intersection ofthe basic and midsagittal planes. Thevision shall not be obstructed within105 degrees from point K on each sideof the midsagittal plane.

§ 1203.15 Positional stability test (roll-offresistance).

(a) Test equipment.

(1) Headforms. The test headformsshall comply with the dimensions of thefull chin ISO reference headforms sizesA, E, J, M, and O.

(2) Test fixture. The headform shall besecured in a test fixture with theheadform’s vertical axis pointingdownward and 45 degrees to thedirection of gravity (see Figure 7 of thispart). The test fixture shall permitrotation of the headform about itsvertical axis and include means to lockthe headform in the face up and facedown positions.

(3) Dynamic impact apparatus. Adynamic impact apparatus shall be usedto apply a shock load to a helmetsecured to the test headform. Thedynamic impact apparatus shall allow a4-kg (8.8-lb) drop weight to slide in aguided free fall to impact a rigid stopanvil (see Figure 7 of this part). Theentire 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 flexiblestrap or cable shall be used to connectthe dynamic impact apparatus to thehelmet. The strap or cable shall be of amaterial having an elongation of nomore 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 hangingposition.

(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 inaccordance with the HPI and fasten theretention system in accordance with themanufacturer’s instructions. Adjust thestraps to remove any slack.

(3) Suspend the dynamic impactsystem from the helmet by positioningthe flexible strap over the helmet along

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the midsagittal plane and attaching thehook over the edge of the helmet asshown in Figure 7 of this part.

(4) Raise the drop weight to a heightof 0.6 m (2 ft) from the stop anvil andrelease it, so that it impacts the stopanvil.

(5) The test shall be repeated with theheadform’s face pointing upwards, sothat the helmet is pulled from front torear.

§ 1203.16 Dynamic strength of retentionsystem 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 dynamicimpact apparatus that allows a 4-kg (8.8-lb) drop weight to slide in a guided freefall to impact a rigid stop anvil (seeFigure 8 of this part). Two cylindricalrollers that spin freely, with a diameterof 12.5 ± 0.5 mm (0.49 in. ± 0.02 in.) anda center-to-center distance of 76.0 ± 1mm (3.0 ± 0.04 in.), shall make up astirrup that represents the bonestructure of the lower jaw. The entiredynamic test apparatus hangs freely onthe retention system. The entire mass ofthe 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 testdevice according to the HPI. Fasten thestrap of the retention system under thestirrup.

(2) Mark the pre-test position of theretention system, with the entiredynamic test apparatus hanging freelyon the retention system.

(3) Raise the 4-kg (8.8-lb) drop weightto a height of 0.6 m (2 ft) from the stopanvil and release it, so that it impactsthe stop anvil.

(4) Record the maximum elongation ofthe retention system during the impact.A marker system or a displacementtransducer, as shown in Figure 8 of thispart, are two methods of measuring theelongation.

§ 1203.17 Impact attenuation test.(a) Impact test instruments and

equipment.(1) Measurement of impact

attenuation. Impact attenuation isdetermined by measuring theacceleration of the test headform duringimpact. Acceleration is measured with auniaxial accelerometer that is capable ofwithstanding a shock of at least 1000 g.The helmet is secured onto theheadform and dropped in a guided freefall, using a monorail or guidewire testapparatus (see Figure 9 of this part),

onto an anvil fixed to a rigid base. Thecenter of the anvil shall be aligned withthe center vertical axis of theaccelerometer. The base shall consist ofa solid mass of at least 135 kg (298 lb),the upper surface of which shall consistof a steel plate at least 12 mm (0.47 in.)thick and having a surface area of atleast 0.10 m2 (1.08 ft2).

(2) Accelerometer. A uniaxialaccelerometer shall be mounted at thecenter of gravity of the test headform,with the sensitive axis aligned within 5degrees of vertical when the testheadform is in the impact position. Theacceleration data channel and filteringshall comply with SAE RecommendedPractice J211 OCT88, Instrumentationfor Impact Tests, Requirements forChannel Class 1000.

(3) Headform and drop assembly—centers of gravity. The center of gravityof the test headform shall be at thecenter of the mounting ball on thesupport assembly and within aninverted cone having its axis verticaland a 10-degree included angle with thevertex at the point of impact. Thelocation of the center of gravity of thedrop assembly (combined test headformand support assembly) must meet thespecifications of Federal Motor VehicleSafety Standard No. 218, MotorcycleHelmets, 49 CFR 571.218 (S7.1.8). Thecenter of gravity of the drop assemblyshall lie within the rectangular volumebounded by x=¥6.4 mm (¥0.25 in.),x=21.6 mm (0.85 in.), y=6.4 mm (0.25in.), and y=¥6.4 mm (¥0.25 in.), withthe origin located at the center of gravityof the test headform. The origin of thecoordinate axes is at the center of themounting ball on the support assembly.The rectangular volume has noboundary along the z-axis. The positivez-axis is downward. The x-y-z axes aremutually perpendicular and havepositive or negative designations asshown in Figure 10 of this part. Figure10 shows an overhead view of the x-yboundary of the drop assembly center ofgravity.

(4) Drop assembly. The combinedmass of the drop assembly, whichconsists of instrumented test headformand support assembly (excluding thetest helmet), shall be 5.0 ± 0.1 kg (11.00± 0.22 lb).

(5) Impact anvils. Impact tests shall beperformed against the three differentsolid (i.e., without internal cavities)steel anvils described in this paragraph(a)(5).

(i) Flat anvil. The flat anvil shall havea flat surface with an impact face havinga minimum diameter of 125 mm (4.92in.). It shall be at least 24 mm (0.94 in.)thick (see Figure 11 of this part).

(ii) Hemispherical anvil. Thehemispherical anvil shall have ahemispherical impact surface with aradius of 48 ± 1 mm (1.89 ± 0.04 in.) (seeFigure 12 of this part).

(iii) Curbstone anvil. The curbstoneanvil shall have two flat faces making anangle of 105 degrees and meeting alonga striking edge having a radius of 15 mm± 0.5 mm (0.59 ± 0.02 in.). The heightof the curbstone anvil shall not be lessthan 50 mm (1.97 in.), and the lengthshall not be less than 200 mm (7.87 in.)(see Figure 13 of this part).

(b) Test Procedure.(1) Instrument system check

(precision and accuracy). The impact-attenuation test instrumentation shall bechecked before and after each series oftests (at least at the beginning and endof each test day) by dropping a sphericalimpactor onto an elastomeric testmedium (MEP). The spherical impactorshall be a 146 mm (5.75 in.) diameteraluminum sphere that is mounted onthe ball-arm connector of the dropassembly. The total mass of thespherical-impactor drop assembly shallbe 5.0 ± 0.1 kg (11.0 ± 0.22 lb). The MEPshall be 152 mm (6 in.) in diameter and25 mm (1 in.) thick, and shall have adurometer of 60 ± 2 Shore A. The MEPshall be affixed to the top surface of aflat 6.35 mm (1⁄4 in.) thick aluminumplate. The geometric center of the MEPpad shall be aligned with the centervertical axis of the accelerometer (seeparagraph (a)(2) of this section). Theimpactor shall be dropped onto the MEPat an impact velocity of 5.44 m/s ± 2%.(Typically, this requires a minimumdrop height of 1.50 meters (4.9 ft) plusa height adjustment to account forfriction losses.) Six impacts, at intervalsof 75 ± 15 seconds, shall be performedat the beginning and end of the testseries (at a minimum at the beginningand end of each test day). The first threeof six impacts shall be consideredwarm-up drops, and their impact valuesshall be discarded from the series. Thesecond three impacts shall be recorded.All recorded impacts shall fall withinthe range of 380 g to 425 g. In addition,the difference between the high and lowvalues of the three recorded impactsshall not be greater than 20 g.

(2) Impact sites. Each of helmets 1through 4 (one helmet for eachconditioning environment) shall impactat four different sites, with two impactson the flat anvil and two impacts on thehemispherical anvil. The center of anyimpact may be anywhere on or abovethe test line, provided it is at least 120mm (4.72 in), measured on the surfaceof the helmet, from any prior impactcenter. Each of helmets 5 through 8 (onehelmet for each conditioning

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environment) shall impact at one site onthe curbstone anvil. The center of thecurbstone impacts may be on oranywhere above the test line. Thecurbstone anvil may be placed in anyorientation as long as the center of theanvil is aligned with the axis of theaccelerometer. As noted in§ 1203.12(d)(1), impact sites, the orderof anvil use (flat and hemispherical),and curbstone anvil sites andorientation shall be chosen by the testpersonnel to provide the most severetest for the helmet. Rivets and othermechanical fasteners, vents, and anyother helmet feature within the testregion are valid test sites.

(3) Impact velocity. The helmet shallbe dropped onto the flat anvil with animpact velocity of 6.2 m/s ± 3% (20.34ft/s ± 3%). (Typically, this requires aminimum drop height of 2 meters (6.56ft), plus a height adjustment to accountfor friction losses.) The helmet shall bedropped onto the hemispherical andcurbstone anvils with an impactvelocity of 4.8 m/s ± 3% (15.75 ft/s ±3%). (Typically, this requires aminimum drop height of 1.2 meters(3.94 ft), plus a height adjustment toaccount for friction losses.) The impactvelocity shall be measured during thelast 40 mm (1.57 in) of free-fall for eachtest.

(4) Helmet position. Prior to each test,the helmet shall be positioned on thetest headform in accordance with theHPI. The helmet shall be secured so thatit does not shift position prior to impact.The helmet retention system shall besecured in a manner that does notinterfere with free-fall or impact.

(5) Data. Record the maximumacceleration in g’s during impact. SeeSubpart C, § 1203.41(b).

Subpart B—Certification

§ 1203.30 Purpose, basis, and scope.(a) Purpose. The purpose of this

subpart is to establish requirements thatmanufacturers and importers of bicyclehelmets subject to the Safety Standardfor Bicycle Helmets (subpart A of thispart 1203) shall issue certificates ofcompliance in the form specified.

(b) Basis. Section 14(a)(1) of theConsumer Product Safety Act (CPSA),15 U.S.C. 2063(a)(1), requires everymanufacturer (including importers) andprivate labeler of a product which issubject to a consumer product safetystandard to issue a certificate that theproduct conforms to the applicablestandard. Section 14(a)(1) furtherrequires that the certificate be basedeither on a test of each product or on a‘‘reasonable testing program.’’ TheCommission may, by rule, designate one

or more of the manufacturers andprivate labelers as the persons who shallissue the required certificate. 15 U.S.C.2063(a)(2).

(c) Scope. The provisions of thissubpart apply to all bicycle helmets thatare subject to the requirements of theSafety Standard for Bicycle Helmets,subpart A of this part 1203.

§ 1203.31 Applicability date.All bicycle helmets manufactured on

or after March 11, 1999, must meet thestandard and must be certified ascomplying with the standard inaccordance with this subpart B.

§ 1203.32 Definitions.The following definitions shall apply

to this subpart:(a) Foreign manufacturer means an

entity that manufactured a bicyclehelmet outside the United States, asdefined in 15 2052(a)(10) and (14).

(b) Manufacturer means the entitythat either manufactured a helmet in theUnited States or imported a helmetmanufactured outside the United States.

(c) Private labeler means an owner ofa brand or trademark that is used on abicycle helmet subject to the standardand that is not the brand or trademarkof the manufacturer of the bicyclehelmet, provided the owner of the brandor trademark caused, authorized, orapproved its use.

(d) Production lot means a quantity ofbicycle helmets from which certainbicycle helmets are selected for testingprior to certifying the lot. All bicyclehelmets in a lot must be essentiallyidentical in those design, construction,and material features that relate to theability of a bicycle helmet to complywith the standard.

(e) Reasonable testing program meansany tests which are identical orequivalent to, or more stringent than,the tests defined in the standard andwhich are performed on one or morebicycle helmets selected from theproduction lot to determine whetherthere is reasonable assurance that all ofthe bicycle helmets in that lot complywith the requirements of the standard.

§ 1203.33 Certification testing.(a) General. Manufacturers, as defined

in § 1203.32(b) to include importers,shall conduct a reasonable testingprogram to demonstrate that theirbicycle helmets comply with therequirements of the standard.

(b) Reasonable testing program. Thisparagraph provides guidance forestablishing a reasonable testingprogram.

(1) Within the requirements set forthin this paragraph (b), manufacturers and

importers may define their ownreasonable testing programs. Reasonabletesting programs may, at the option ofmanufacturers and importers, beconducted by an independent thirdparty qualified to perform such testingprograms. However, manufacturers andimporters are responsible for ensuringcompliance with all requirements of thestandard in subpart A of this part.

(2) As part of the reasonable testingprogram, the bicycle helmets shall bedivided into production lots, andsample bicycle helmets from eachproduction lot shall be tested. Wheneverthere is a change in parts, suppliers ofparts, or production methods, and thechange could affect the ability of thebicycle helmet to comply with therequirements of the standard, themanufacturer shall establish a newproduction lot for testing.

(3) The Commission will test forcompliance with the standard by usingthe standard’s test procedures. However,a reasonable testing program need notbe identical to the tests prescribed in thestandard.

(4) If the reasonable testing programshows that a bicycle helmet may notcomply with one or more requirementsof the standard, no bicycle helmet in theproduction lot can be certified ascomplying until sufficient actions aretaken that it is reasonably likely that nononcomplying bicycle helmets remainin the production lot. All identifiednoncomplying helmets in the lot mustbe destroyed or altered by repair,redesign, or use of a different materialor component, to the extent necessary tomake them conform to the standard.

(5) The sale or offering for sale of abicycle helmet that does not complywith the standard is a prohibited act anda violation of section 19(a) of the CPSA(15 U.S.C. 2068(a)), regardless ofwhether the bicycle helmet has beenvalidly certified.

§ 1203.34 Product certification andlabeling by manufacturers (includingimporters).

(a) Form of permanent label ofcertification. Manufacturers, as definedin § 1203.32(a), shall issue certificates ofcompliance for bicycle helmetsmanufactured after March 11, 1999, inthe form of a durable, legible, andreadily visible label meeting therequirements of this section. This labelis the helmet’s certificate of compliance,as that term is used in section 14 of theCPSA, 15 U.S.C. 2063.

(b) Contents of certification label. Thecertification labels required by thissection shall contain the following:

(1) The statement ‘‘Complies withU.S. CPSC Safety Standard for Bicycle

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Helmets for Persons Age 5 and Older’’or ‘‘Complies with U.S. CPSC SafetyStandard for Bicycle Helmets forPersons Age 1 and Older (ExtendedHead Coverage)’’, as appropriate; thislabel may spell out ‘‘U.S. ConsumerProduct Safety Commission’’ instead of‘‘U.S. CPSC’’;

(2) The name of the U.S. manufactureror importer responsible for issuing thecertificate or the name of a privatelabeler;

(3) The address of the U.S.manufacturer or importer responsiblefor issuing the certificate or, if the nameof a private labeler is on the label, theaddress of the private labeler;

(4) The name and address of theforeign manufacturer, if the helmet wasmanufactured outside the United States;

(5) The telephone number of the U.S.manufacturer or importer responsiblefor issuing the certificate or, if the nameof a private labeler is on the label, thetelephone number of the private labeler;

(6) An identification of the productionlot; and

(7) The uncoded month and year theproduct was manufactured.

(c) Coding. (1) The informationrequired by paragraphs (b)(4) and (b)(6)of this section, and the informationreferred to in paragraph (c)(2) of thissection, may be in code, provided:

(i) The person or firm issuing thecertificate maintains a written record ofthe meaning of each symbol used in thecode, and

(ii) The record shall be made availableto the distributor, retailer, consumer,and Commission upon request.

(2) A serial number may be used inplace of a production lot identificationon the helmet if it can serve as a codeto identify the production lot. If abicycle helmet is manufactured for saleby a private labeler, and if the name ofthe private labeler is on the certificationlabel, the name of the manufacturer orimporter issuing the certificate, and thename and address of any foreignmanufacturer, may also be in code.

(d) Placement of the label(s). Theinformation required by paragraphs(b)(2), (b)(3), and (b)(5) of this sectionmust be on one label. The other requiredinformation may be on separate labels.The label(s) required by this sectionmust be affixed to the bicycle helmet. Ifthe label(s) are not immediately visibleto the ultimate purchaser of the bicyclehelmet prior to purchase because ofpackaging or other marketing practices,a second label is required. That labelshall state, as appropriate, ‘‘Complieswith U.S. CPSC Safety Standard forBicycle Helmets for Persons Age 5 andOlder’’, or ‘‘Complies with U.S. CPSCSafety Standard for Bicycle Helmets for

Persons Age 1 and Older (ExtendedHead Coverage)’’. The label shall belegible, readily visible, and placed onthe main display panel of the packagingor, if the packaging is not visible beforepurchase (e.g., catalog sales), on thepromotional material used with the saleof the bicycle helmet. This label mayspell out ‘‘U.S. Consumer ProductSafety Commission’’ instead of ‘‘U.S.CPSC.’’

(e) Additional provisions forimporters.

(1) General. The importer of anybicycle helmet subject to the standard insubpart A of this part 1203 must issuethe certificate of compliance required bysection 14(a) of the CPSA and thissection. If a reasonable testing programmeeting the requirements of this subparthas been performed by or for the foreignmanufacturer of the product, theimporter may rely in good faith on suchtests to support the certificate ofcompliance, provided:

(i) The importer is a resident of theUnited States or has a resident agent inthe United States,

(ii) There are records of such testsrequired by § 1203.41 of subpart C ofthis part, and

(iii) Such records are available to theCommission within 48 hours of arequest to the importer.

(2) Responsibility of importers.Importers that rely on tests by theforeign manufacturer to support thecertificate of compliance shall—inaddition to complying with paragraph(e)(1) of this section—examine therecords supplied by the manufacturer todetermine that they comply with§ 1203.41 of subpart C of this part.

Subpart C—Recordkeeping

§ 1203.40 Effective date.This subpart is effective March 10,

1999, and applies to bicycle helmetsmanufactured after that date.

§ 1203.41 Recordkeeping requirements.(a) General. Every person issuing

certificates of compliance for bicyclehelmets subject to the standard insubpart A of this part shall maintainrecords which show that the certificatesare based on a reasonable testingprogram. The records shall bemaintained for a period of at least 3years from the date of certification of thelast bicycle helmet in each productionlot. These records shall be available,upon request, to any designated officeror employee of the Commission, inaccordance with section 16(b) of theCPSA, 15 U.S.C. 2065(b). If the recordsare not physically available during theinspection because they are maintained

at another location, the firm mustprovide them to the staff within 48hours.

(b) Records of helmet tests. Completetest records shall be maintained. Theserecords shall contain the followinginformation.

(1) An identification of the bicyclehelmets tested;

(2) An identification of the productionlot;

(3) The results of the tests, includingthe precise nature of any failures;

(4) A description of the specificactions taken to address any failures;

(5) A detailed description of the tests,including the helmet positioning index(HPI) used to define the proper positionof the helmet on the headform;

(6) The manufacturer’s name andaddress;

(7) The model and size of each helmettested;

(8) Identifying information for eachhelmet tested, including the productionlot for each helmet;

(9) The environmental conditionunder which each helmet was tested,the duration of the helmet’sconditioning, the temperatures in eachconditioning environment, and therelative humidity and temperature ofthe laboratory;

(10) The peripheral vision clearance;(11) A description of any failures to

conform to any of the labeling andinstruction requirements;

(12) Performance impact results,stating the precise location of impact,type of anvil used, velocity prior toimpact, and maximum accelerationmeasured in g’s;

(13) The results of the positionalstability test;

(14) The results of the dynamicstrength of retention system test;

(15) The name and location of the testlaboratory;

(16) The name of the person(s) whoperformed the test;

(17) The date of the test; and(18) The system check results.(c) Format for records. The records

required to be maintained by thissection may be in any appropriate formor format that clearly provides therequired information. Certification testresults may be kept on paper,microfiche, computer disk, or otherretrievable media. Where records arekept on computer disk or otherretrievable media, the records shall bemade available to the Commission onpaper copies, or via electronic mail inthe same format as paper copies, uponrequest.

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Subpart D—Requirements For BicycleHelmets Manufactured From March 17,1995, Through March 10, 1999

§ 1203.51 Purpose and basis.

The purpose and basis of this subpartis to protect bicyclists from headinjuries by ensuring that bicycle helmetscomply with the requirements ofappropriate existing voluntarystandards, as provided in 15 U.S.C.6004(a).

§ 1203.52 Scope and effective date.

(a) This subpart D is effective March17, 1995, except for § 1203.53(a)(8),which is effective March 10, 1998. Thissubpart D shall apply to bicycle helmetsmanufactured from March 17, 1995,through March 10, 1999, inclusive. Suchbicycle helmets shall comply with therequirements of one of the standardsspecified in § 1203.53. This subpartshall be considered a consumer productsafety standard issued under theConsumer Product Safety Act.

(b) The term ‘‘bicycle helmet’’ isdefined at § 1203.4(b).

(c) These interim mandatory safetystandards will not apply to bicyclehelmets manufactured after March 10,1999. Those helmets are subject to therequirements of Subparts A through C ofthis part 1203.

§ 1203.53 Interim safety standards.

(a) Bicycle helmets must comply withone or more of the following standards.The standards in paragraphs (a)(1)through (a)(7) of this section areincorporated herein by reference:

(1) American National StandardsInstitute (ANSI) standard Z90.4–1984,Protective Headgear for Bicyclists,

(2) ASTM standards F 1447–93 or F1447–94, Standard Specification forProtective Headgear Used in Bicycling,incorporating the relevant provisions ofASTM F 1446–93 or ASTM F 1446–94,Standard Test Methods for Equipmentand Procedures Used in Evaluating thePerformance Characteristics ofProtective Headgear, respectively,

(3) Canadian Standards Associationstandard, Cycling Helmets—CAN/CSA–D113.2–M89,

(4) Snell Memorial Foundation (Snell)1990 Standard for Protective Headgearfor Use in Bicycling (designation B–90),

( 5) Snell 1990 Standard for ProtectiveHeadgear for Use in Bicycling, includingMarch 9, 1994 Supplement (designationB–90S),

(6) Snell 1994 Standard for ProtectiveHeadgear for Use in Non-MotorizedSports (designation N–94), or

(7) Snell 1995 standard for ProtectiveHeadgear for Use with Bicycles B–95.

(8) Subparts A through C of this part1203.

(b) The incorporation by reference ofthe standards listed in paragraphs (a)(1)through (a)(7) are approved by theDirector of the Federal Register inaccordance with 5 U.S.C. 552(a) and 1CFR part 51. Copies of the standardsmay be obtained as follows. Copies ofthe ANSI Z90.4 standard are availablefrom: American National StandardsInstitute, 11 W. 42nd Street, 13th Floor,New York, NY 10036. Copies of theASTM standards are available from:ASTM, 100 Barr Harbor Drive, WestConshohocken, PA 19428–2959. Copiesof the Canadian Standards AssociationCAN/CSA–D113.2–M89 standard areavailable from: CSA, 178 RexdaleBoulevard, Rexdale (Toronto), Ontario,Canada, M9W 1R3. Copies of the Snellstandards are available from: SnellMemorial Foundation, Inc., 6731–A32nd Street, North Highlands, CA95660. Copies may be inspected at theOffice of the Secretary, ConsumerProduct Safety Commission, 4330 East-West Highway, Bethesda, Maryland20814, or at the Office of the FederalRegister, 800 N. Capitol Street NW,Room 700, Washington, DC.

BILLING CODE 6355–01–P

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Figures to Part 1203

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Dated: February 13, 1998.Todd A. Stevenson,Acting Secretary, Consumer Product SafetyCommission.[FR Doc. 98–4214 Filed 3–9–98; 8:45 am]BILLING CODE 6355–01–C