62662 federal register /vol. 60, no. 234/wednesday ... · 62662 federal register/vol. 60, no....

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62662 Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Proposed Rules 1 The Commission approved this Federal Register notice by a vote of 2–1. Chairman Ann Brown and Commissioner Thomas H. Moore voted to approve it as published. Commissioner Mary Sheila Gall voted to approve the proposed rule with a change, which was not adopted by the Commission, to give companies more time to comply with agency requests for records. 2 Gregory B. Rodgers, Deborah K. Tinsworth, Curtis Polen, Suzanne Cassidy, Celestine M. Trainor, Scott R. Heh, Mary F. Donaldson, ‘‘Bicycle Use and Hazard Patterns in the United States,’’ U.S. Consumer Product Safety Commission (June 1994) (‘‘Bicycle Use Study’’). 3 Jeffrey J. Sachs, MPH; Patricia Holmgreen, M.S.; Suzanne M. Smith, M.D.; and Daniel M. Sosin, M.D., ‘‘Bicycle-Associated Head Injuries and Deaths in the United States from 1984 through 1988,’’ Journal of the American Medical Association 266 (December 1991): 3016–3018. 4 Robert S. Thompson, M.D.; Frederic P. Rivara, M.D.; and Diane C. Thompson, M.S., ‘‘A Case Control Study of the Effectiveness of Bicycle Safety Helmets,’’ The New England Journal of Medicine 320 (May 1989): 1361–1367. CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1203 Proposed Rule: Safety Standard for Bicycle Helmets AGENCY: Consumer Product Safety Commission. ACTION: Proposed rule. SUMMARY: Pursuant to the Children’s Bicycle Helmet Safety Act of 1994, the Commission is proposing a safety standard that would require bicycle helmets to meet impact-attenuation and other requirements. This proposal modifies the bicycle helmet standard proposed by the Commission in the Federal Register of August 15, 1994. The proposed standard establishes requirements derived from one or more of the voluntary standards applicable to bicycle helmets. In addition, the proposed standard includes requirements specifically applicable to children’s helmets and requirements to prevent helmets from coming off during an accident. The proposed standard also contains testing and recordkeeping requirements to ensure that bicycle helmets meet the standard’s requirements. DATES: Comments on the proposal should be submitted no later than February 20, 1996. Comments on elements of the proposal that, if issued, would constitute collection of information requirements under the Paperwork Reduction Act may be filed with the Office of Management and Budget (‘‘OMB’’). OMB is required to make a decision concerning the collections of information contained in the proposed rule between 30 and 60 days after publication. Thus, although comments will be received by OMB until February 5, 1996, a comment to OMB is best assured of having its full effect if OMB receives it by January 4, 1996. ADDRESSES: Comments to the Commission should be mailed to the Office of the Secretary, Consumer Product Safety Commission, Washington, D.C. 20207, or delivered to the Office of the Secretary, Consumer Product Safety Commission, room 502, 4330 East-West Highway, Bethesda, Maryland 20814–4408, telephone (301)504–0800. Comments also may be filed with the Commission by facsimile to (301)504–0127, or by electronic mail via [email protected]. Comments should include a caption or cover indicating that they are directed to the Office of the Secretary and are comments on the revised proposed Safety Standard for Bicycle Helmets. Comments to OMB should be directed to the Desk Officer for the Consumer Product Safety Commission, Office of Information and Regulatory Affairs, OMB, Washington, D.C. 20503. The Commission encourages commenters to provide copies of such comments to the Commission’s Office of the Secretary, with a caption or cover letter identifying the materials as comments submitted to OMB on the proposed collection of information requirements for bicycle helmets. FOR FURTHER INFORMATION CONTACT: Scott Heh, Project Manager, Directorate for Engineering Sciences, Consumer Product Safety Commission, Washington, D.C. 20207; telephone (301) 504–0494 ext. 1308. SUPPLEMENTARY INFORMATION: A. Introduction and Background Introduction. In this notice, the Consumer Product Safety Commission (‘‘the Commission’’ or ‘‘CPSC’’) proposes a mandatory safety standard applicable to bicycle helmets. 1 This proposal modifies the bicycle helmet standard proposed by the Commission in the Federal Register of August 15, 1994. 59 FR 41719. The Commission seeks comments from interested members of the public on the revised proposed standard. Comments should be limited to those aspects of the proposed standard that have changed substantively from the earlier proposal, or that are affected by a substantive change. Because of the growing use of helmets, other nations may be developing or revising safety standards for bicycle helmets. Accordingly, the Commission invites comments from counterpart agencies in foreign governments, foreign standards developers, and others who might be interested in this proposed standard. This invitation is in addition to the routine international notification of this proposed rule that is provided by the World Trade Organization Agreement on Technical Barriers to Trade. Background. Head injury is a leading cause of accidental death and disability among children in the United States, resulting in over 100,000 hospitalizations every year. Studies have shown that children under the age of 14 are more likely to sustain head injuries than adults, and that children’s head injuries are often more severe than those sustained by adults. In general, head injuries fall under one of two main categories—focal and diffuse. Focal injuries are limited to the area of impact, and include injuries such as contusions, hematomas, lacerations, and fractures. Diffuse brain injuries (also known as diffuse axonal injury) involve trauma to the neural and vascular elements of the brain at the microscopic level. The effects of such diffuse damage may vary from a completely reversible injury, such as a mild concussion, to prolonged coma and death. Based on data from CPSC’s National Electronic Injury Surveillance System (‘‘NEISS’’), an estimated 606,000 bicycle-related injuries were treated in U.S. hospital emergency rooms in 1994. In addition, about 1,000 bicycle-related fatalities occur each year, according to the National Safety Council. A Commission study of bicycle use and hazard patterns in 1993 indicated that almost one-third of the injuries involved the head. 2 Published data indicate that, in recent years, almost two-thirds of all bicycle-related deaths involved head injury. 3 Younger children are at particular risk of head injury. The Commission’s 1993 study indicated that when other factors were held constant statistically, the injury risk for children under age 15 was over 5 times the risk for older riders. About one-half of the injuries to children under the age of 10 involved the head, compared to about one-fifth of the injuries to older riders. Children were also less likely to have been wearing a helmet at the time of a bicycle-related incident than were adults. Research has shown that helmets may reduce the risk of head injury to bicyclists by about 85 percent, and the risk of brain injury by about 88 percent. 4 The Commission’s Bicycle Use Study

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62662 Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Proposed Rules

1 The Commission approved this Federal Registernotice by a vote of 2–1. Chairman Ann Brown andCommissioner Thomas H. Moore voted to approveit as published. Commissioner Mary Sheila Gallvoted to approve the proposed rule with a change,which was not adopted by the Commission, to givecompanies more time to comply with agencyrequests for records.

2 Gregory B. Rodgers, Deborah K. Tinsworth,Curtis Polen, Suzanne Cassidy, Celestine M.Trainor, Scott R. Heh, Mary F. Donaldson, ‘‘BicycleUse and Hazard Patterns in the United States,’’ U.S.Consumer Product Safety Commission (June 1994)(‘‘Bicycle Use Study’’).

3 Jeffrey J. Sachs, MPH; Patricia Holmgreen, M.S.;Suzanne M. Smith, M.D.; and Daniel M. Sosin,M.D., ‘‘Bicycle-Associated Head Injuries and Deathsin the United States from 1984 through 1988,’’Journal of the American Medical Association 266(December 1991): 3016–3018.

4 Robert S. Thompson, M.D.; Frederic P. Rivara,M.D.; and Diane C. Thompson, M.S., ‘‘A CaseControl Study of the Effectiveness of Bicycle SafetyHelmets,’’ The New England Journal of Medicine320 (May 1989): 1361–1367.

CONSUMER PRODUCT SAFETYCOMMISSION

16 CFR Part 1203

Proposed Rule: Safety Standard forBicycle Helmets

AGENCY: Consumer Product SafetyCommission.ACTION: Proposed rule.

SUMMARY: Pursuant to the Children’sBicycle Helmet Safety Act of 1994, theCommission is proposing a safetystandard that would require bicyclehelmets to meet impact-attenuation andother requirements. This proposalmodifies the bicycle helmet standardproposed by the Commission in theFederal Register of August 15, 1994.

The proposed standard establishesrequirements derived from one or moreof the voluntary standards applicable tobicycle helmets. In addition, theproposed standard includesrequirements specifically applicable tochildren’s helmets and requirements toprevent helmets from coming off duringan accident. The proposed standard alsocontains testing and recordkeepingrequirements to ensure that bicyclehelmets meet the standard’srequirements.DATES: Comments on the proposalshould be submitted no later thanFebruary 20, 1996.

Comments on elements of theproposal that, if issued, wouldconstitute collection of informationrequirements under the PaperworkReduction Act may be filed with theOffice of Management and Budget(‘‘OMB’’). OMB is required to make adecision concerning the collections ofinformation contained in the proposedrule between 30 and 60 days afterpublication. Thus, although commentswill be received by OMB until February5, 1996, a comment to OMB is bestassured of having its full effect if OMBreceives it by January 4, 1996.ADDRESSES: Comments to theCommission should be mailed to theOffice of the Secretary, ConsumerProduct Safety Commission,Washington, D.C. 20207, or delivered tothe Office of the Secretary, ConsumerProduct Safety Commission, room 502,4330 East-West Highway, Bethesda,Maryland 20814–4408, telephone(301)504–0800. Comments also may befiled with the Commission by facsimileto (301)504–0127, or by electronic mailvia [email protected]. Comments shouldinclude a caption or cover indicatingthat they are directed to the Office of theSecretary and are comments on the

revised proposed Safety Standard forBicycle Helmets.

Comments to OMB should be directedto the Desk Officer for the ConsumerProduct Safety Commission, Office ofInformation and Regulatory Affairs,OMB, Washington, D.C. 20503. TheCommission encourages commenters toprovide copies of such comments to theCommission’s Office of the Secretary,with a caption or cover letter identifyingthe materials as comments submitted toOMB on the proposed collection ofinformation requirements for bicyclehelmets.FOR FURTHER INFORMATION CONTACT:Scott Heh, Project Manager, Directoratefor Engineering Sciences, ConsumerProduct Safety Commission,Washington, D.C. 20207; telephone(301) 504–0494 ext. 1308.

SUPPLEMENTARY INFORMATION:

A. Introduction and BackgroundIntroduction. In this notice, the

Consumer Product Safety Commission(‘‘the Commission’’ or ‘‘CPSC’’)proposes a mandatory safety standardapplicable to bicycle helmets.1 Thisproposal modifies the bicycle helmetstandard proposed by the Commissionin the Federal Register of August 15,1994. 59 FR 41719.

The Commission seeks commentsfrom interested members of the publicon the revised proposed standard.Comments should be limited to thoseaspects of the proposed standard thathave changed substantively from theearlier proposal, or that are affected bya substantive change.

Because of the growing use ofhelmets, other nations may bedeveloping or revising safety standardsfor bicycle helmets. Accordingly, theCommission invites comments fromcounterpart agencies in foreigngovernments, foreign standardsdevelopers, and others who might beinterested in this proposed standard.This invitation is in addition to theroutine international notification of thisproposed rule that is provided by theWorld Trade Organization Agreementon Technical Barriers to Trade.

Background. Head injury is a leadingcause of accidental death and disabilityamong children in the United States,resulting in over 100,000hospitalizations every year. Studieshave shown that children under the age

of 14 are more likely to sustain headinjuries than adults, and that children’shead injuries are often more severe thanthose sustained by adults.

In general, head injuries fall underone of two main categories—focal anddiffuse. Focal injuries are limited to thearea of impact, and include injuriessuch as contusions, hematomas,lacerations, and fractures. Diffuse braininjuries (also known as diffuse axonalinjury) involve trauma to the neural andvascular elements of the brain at themicroscopic level. The effects of suchdiffuse damage may vary from acompletely reversible injury, such as amild concussion, to prolonged comaand death.

Based on data from CPSC’s NationalElectronic Injury Surveillance System(‘‘NEISS’’), an estimated 606,000bicycle-related injuries were treated inU.S. hospital emergency rooms in 1994.In addition, about 1,000 bicycle-relatedfatalities occur each year, according tothe National Safety Council.

A Commission study of bicycle useand hazard patterns in 1993 indicatedthat almost one-third of the injuriesinvolved the head.2 Published dataindicate that, in recent years, almosttwo-thirds of all bicycle-related deathsinvolved head injury.3

Younger children are at particular riskof head injury. The Commission’s 1993study indicated that when other factorswere held constant statistically, theinjury risk for children under age 15was over 5 times the risk for olderriders. About one-half of the injuries tochildren under the age of 10 involvedthe head, compared to about one-fifth ofthe injuries to older riders. Childrenwere also less likely to have beenwearing a helmet at the time of abicycle-related incident than wereadults.

Research has shown that helmets mayreduce the risk of head injury tobicyclists by about 85 percent, and therisk of brain injury by about 88 percent.4The Commission’s Bicycle Use Study

62663Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Proposed Rules

5 Supra note 1.

6 Heh. S., Log of ASTM F08.53 HeadgearSubcommittee Meeting held May 21, 1992, Date ofEntry—June 17, 1992. Office of the Secretary, U.S.Consumer Product Safety Commission, Washington,D.C. 20207.

found that about 18 percent of bicyclistswear helmets.5

On June 16, 1994, the Children’sBicycle Helmet Safety Act of 1994 (the‘‘Act’’ or ‘‘the Bicycle Helmet SafetyAct’’) was enacted. 15 U.S.C. 6001–6006. Section 205 of this Act providesthat bicycle helmets manufactured morethan 9 months from that date shallconform 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.

Section 205(c) of the Act directed theConsumer Product Safety Commissionto begin a proceeding under theAdministrative Procedure Act, 5 U.S.C.553, to:

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

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

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

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

Section 205(c) the Act provides thatthe final standard shall take effect 1 yearfrom the date it is issued. 15 U.S.C.6004(c). Section 205(d) of the Actprovides that failure to conform to aninterim standard shall be considered aviolation of a consumer product safetystandard issued under the ConsumerProduct Safety Act (‘‘CPSA’’), 15 U.S.C.2051–2084. Section 205(d) also providesthat the final standard shall beconsidered to be a consumer productsafety standard issued under the CPSA.However, section 205(c) of the Act

provides that the provisions of theCPSA regarding rulemaking procedures,statutory findings, and judicial review(15 U.S.C. 2056, 2058, 2060, and2079(d)) shall not apply to thisproceeding or to the final standard. 15U.S.C. 6004(c). When the final standardbecomes effective, it will be codified at16 CFR 1203 and will replace theinterim standards. 15 U.S.C. 6004(d).

B. Originally Proposed StandardThe 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 final safety standard forbicycle helmets. 59 FR 41,719 (August15, 1994).

The major features of the originallyproposed standard were as follows:

1. Impact attenuation. The originallyproposed standard measures the abilityof the helmet to protect the head in acollision by securing the helmet on aheadform and dropping the helmet/headform assembly from various heightsonto a fixed steel anvil. The originalproposal specified a constant mass of 5kg for the drop assembly (not includingthe helmet). However, the Commissionrequested comment on the alternative ofspecifying a different drop mass for eachheadform size.

Under the proposed standard, thehelmet is tested with three types ofanvils (flat, hemispherical, and‘‘curbstone,’’ as shown in Figures 11, 12,and 13 of the revised proposed standardpublished in this notice). These anvilsrepresent types of surfaces that may beencountered in actual 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 (3–9 °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. Inaddition, maximum time limits of 6milliseconds (‘‘ms’’) and 3 ms were

originally proposed for the allowableduration of the impact at the 150-g and200-g levels, respectively.

One difference from the ANSI, ASTM,and Snell standards that was originallyproposed for the mandatory standardwas the designation for the area of thehelmet that must provide impactprotection. The originally proposed areaof impact protection for the CPSCstandard was reached by combining theANSI and ASTM procedures. Theprocedure for defining the area of thehelmet subject to impact attenuationtesting is described at § 1203.11.

2. Children’s helmets. The originallyproposed mandatory standard specifiedan increased area of head coverage forsmall children. A study by Biokinetics& Associates Ltd. found differences inanthropometric characteristics betweenyoung children’s heads and olderchildren’s and adult heads.6 This studyled to an ASTM proposal to change theposition of the basic plane (ananthropometric reference plane thatincludes the external ear openings andthe bottom edges of the eye sockets) onthe smallest test headform to be morerepresentative of children ages 4 yearsand under. Originally, § 1203.11(b)proposed an extent-of-protectionrequirement for helmets intended forchildren 4 years and under based on theadjusted basic plane.

3. Retention system. The dynamicstrength of the retention system testaddresses the strength of the chin strapto ensure against breakage or excessiveelongation of the strap that maycontribute to a helmet coming off thehead during an accident.

The test requires that the chin strapremain intact and not elongate morethan 30 mm (1.2 inches) when subjectedto a ‘‘shock load’’ of a 4-kg (8.8-lb)weight falling a distance of 0.6 m (2 ft)onto a steel stop anvil (see Figure 8).This test is performed on one helmetunder ambient conditions and on threeother helmets after each is subjected toone of the different hot, cold, and wetenvironments.

4. Peripheral vision. Section 1203.14of the originally proposed mandatorystandard requires that a helmet shallallow a field of vision of 105 degrees toboth the left and right of straight ahead.This requirement is consistent with theANSI, ASTM, and Snell standards.

5. Labels and instructions. Section1203.6 of the proposed mandatorystandard requires certain labels on thehelmet, which are consistent with all

62664 Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Proposed Rules

7 Forum on Head Protection in RecreationalSports, Harborview Injury Prevention and ResearchCenter (February 18, 1994); Chairman’s Roundtable,Multi-Activity Helmets, U.S. Consumer ProductSafety Commission (September 19, 1994).

three U.S. voluntary standards. Theselabels provide the model designationand warnings regarding the protectivelimitations of the helmet. The labelsalso provide instructions regarding howto care for the helmet and what to do ifthe helmet receives an impact. Thelabels also must carry the statement‘‘Not for Motor Vehicle Use’’ and awarning that for maximum protectionthe helmet must be fitted and attachedproperly to the wearer’s head inaccordance with the manufacturer’sfitting instructions.

The proposed mandatory standardalso requires that helmets beaccompanied by fitting and positioninginstructions, including graphicrepresentation of proper positioning. Asnoted above, the proposed mandatorystandard 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.Thus, the proposed mandatory standardcontains the labeling requirementdescribed above to help ensure thatusers will purchase the proper helmetand adjust it correctly.

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. Roll off. The originally proposedmandatory standard specified a testprocedure 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.

These safety requirements, which areproposed pursuant to the BicycleHelmet Safety Act, are found in SubpartA of the proposed Safety Standard forBicycle Helmets. The commentsreceived in response to the originalproposal, the Commission’s responses tothese comments, and other changes tothe original proposal are discussed insection C of this notice.

Under the authority of section 14(a) ofthe CPSA, the Commission alsoproposed certification testing andlabeling requirements to ensure thatbicycle helmets meet the standard’s

safety requirements. These certificationrequirements are found in Subpart B ofthe proposed Safety Standard forBicycle Helmets and are discussed insection D of this notice.

Also, under the authority of section16(b) of the CPSA, the Commissionproposed requirements that records bekept of the required certification testing.These recordkeeping requirements arefound in Subpart C of the proposedSafety Standard for Bicycle Helmets andare discussed in section E of this notice.

The interim standards, which arecurrently codified as 16 CFR 1203, willcontinue to apply to bicycle helmetsmanufactured from March 16, 1995, tothe date that the final standard becomeseffective. Accordingly, the interimstandards will continue to be codified,as Subpart D of the standard.

As discussed below, although theCommission is proposing certainchanges to the standard, the revisedproposal still addresses each of theelements in the original proposal.

The Commission received 37comments on the proposed bicyclehelmet standard from 30 individualsand organizations. After consideringthese comments and other availableinformation, the Commission decided topropose certain revisions to theoriginally proposed standard. Theproposed revisions are discussed insections C–E of this notice.

C. The Revised Proposed Standard—Comments, Responses and OtherChanges

Comment: Definition of bicyclehelmet. The original proposal definedbicycle helmet as ‘‘any headgearmarketed as suitable for providingprotection from head injuries whileriding a bicycle.’’ One commentsuggested that the definition of aproduct should not be in terms of howit is marketed.

Response: The Commission disagreeswith this comment. It is important thatall products marketed as suitable forproviding protection from head injurieswhile bicycling meet the applicablesafety standard. However, theCommission proposes to amend thedefinition to include not only productsspecifically marketed for use as abicycle helmet but also those productsthat can be reasonably foreseen to beused for that purpose.

Comment: Compliance with third-party standards as compliance with therule. The Snell Memorial Foundationurged that the following statement beadded to the certification portion of therule that describes a reasonable testingprogram: ‘‘Helmets that are certified bythe Snell Memorial Foundation to the

Snell B–95 or Snell N–94 Standards areconsidered to be in compliance withthis regulation.’’

Response: One of the objectives of theChildren’s Bicycle Helmet Safety Act of1994 is to establish a unified bicyclehelmet safety standard that isrecognized nationally by allmanufacturers and consumers. TheCommission believes it would becontrary to the intent of the Act toprovide that certified conformance toany particular existing voluntarystandard is compliance with themandatory rule.

Allowing third-party certification to avoluntary standard to serve ascompliance to the mandatory rulewould not adequately deal with theissue of recalls or other correctiveactions if defective helmets arenonetheless produced. A third party canonly decertify helmets that do not meetits standard and can only request thatthe responsible firm take appropriatecorrective action for previouslyproduced helmets. CPSC, on the otherhand, has the authority to order a firmto take corrective actions if necessaryand to assess penalties whereappropriate. Accordingly, theCommission declines to adopt thelanguage requested by this commenter.

Comment: Multiple-activity helmets.Some commenters recommended thatthe CPSC include provisions forchildren’s bicycle helmets so thathelmets would provide protection inactivities in addition to bicycling, suchas skateboarding, skating, sledding, andthe like. Two commentersrecommended that the CPSC bikehelmet standard also apply to helmetsfor roller skating and in-line skating.Other comments stated that theCommission should not delaypromulgation of the bike helmetstandard while multi-activity issues areexplored.

Response: Recent forums on headprotection concluded that there is aneed to develop helmets that aresuitable for use in a number ofrecreational activities, not justbicycling.7 However, the CPSC’sauthority under the Children’s BicycleHelmet Safety Act of 1994 is to setmandatory requirements for bicyclehelmets. Establishing criteria forproducts other than bicycle helmetswould require the Commission to followthe procedures and make the findings

62665Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Proposed Rules

8 Corner JP, Whitney CW, O’Rourke N, andMorgan DE. Motorcycle and Bicycle ProtectiveHelmets—Requirements. Dept. of Trans. andComm., Federal Office of Road Safety, Australia,May 1987. Lane JC. Helmets for Child Bicyclists,Some Biomedical Considerations. Federal Dept. ofTransport, Office of Road Safety, Australia, CR 47,1986.

prescribed by the CPSA or the FederalHazardous Substances Act (‘‘FHSA’’).

In March 1994, Snell established theN–94 Standard For Protective HeadgearFor Use in Non-Motorized Sports. Thisstandard provides greater head coveragethan current bicycle helmet standards,tests for multiple impacts at a singlelocation on the helmet, and tests to seeif the helmet will roll off on impact.However, the Commission lacks datathat multiple impacts at a singlelocation are a factor in injuries topersons wearing bicycle helmets or thatgreater helmet coverage is needed forbicycle accidents. Furthermore, the useof an additional anvil in the Snell N–94test may preclude the use of somecurrent vent designs used in bicyclehelmets. The Commission is aware ofonly a few helmets currently on themarket that are certified to thisstandard.

Activities like roller skating, in-lineskating, and skateboarding are typicallyconducted on the same types of surfacesas bicycling and can generate speedssimilar to bicycling. In addition, theseother activities do not put the user at ahigher height than when using a bicycle.Thus, fall heights can be expected to besimilar. It is reasonable to assume thatthe test requirements in the bicyclehelmet regulation would allow thehelmet to provide some protection forother activities—such as in-line skating,roller skating and skateboarding—untilmultiple-activity helmets becomewidely available. However, theCommission does not have sufficientdata on the benefits and costs ofadditional features directed at injuriesincurred other than bicycling to makethe findings that would be required byeither 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 othertypes of helmets. Accordingly, thisproposed regulation only addressesbicycle helmets.

Comment: General constructionprovisions. Section 1203.5 of theoriginally proposed mandatory standardincluded several provisions thataddressed general constructioncharacteristics of a bicycle helmet.These provisions specified that helmetsshall be designed to reduce theacceleration forces imparted to thewearer’s head by an impact and toremain on the wearer’s head duringimpact. It was also specified thathelmets shall be constructed not to beharmful or potentially injurious to thewearer. For example, the original

proposal stated that the helmet surfaceshall not have projections that mayincrease the likelihood of injury to therider during an accident. In addition,the original proposal provided thatconstruction materials should beresistant to environmental conditionsthat may be reasonably expected duringhelmet use and storage and shall not beharmful to the wearer.

Some commenters on the proposedrule stated that many of therequirements in § 1203.5 are subjective,since they have no performance-relatedcriteria. One respondent suggested thatthese sections be located in aninformative annex rather than in thebody of the standard.

Response: Sections 1203.5(a) and (d)of the original proposal—titled‘‘General’’ and ‘‘Materials,’’respectively—contained no objectiveperformance criteria to establishcompliance. Section 1203.5(c)—‘‘Retention System’’—was redundantsince it merely referenced testrequirements elsewhere in the standard.Accordingly, the Commission iseliminating these paragraphs from therevised proposal.

The first proposed standard requiredthat external projections must ‘‘readilybreak away’’ and internal projectionsshall be protected by ‘‘some means ofcushioning.’’ In response to thecomments that this language wassubjective, the Commission is revisingthe language to define more objectiveperformance criteria. The revisedrequirement is that the helmet beexamined after impact testing todetermine whether there are any rigidinternal projections that could contactthe wearer’s head.

Comment: Children’s peak g-value.Some comments recommended that thepeak g-value for children be droppedfrom 300 g to 250 g or 200 g. Somecommenters suggested that no change bemade in the g-value.

Response: Despite the high incidenceof head injury among children, studiesaddressing mechanisms of injury andrecovery are lacking. Therefore, eventhough children make up the majority ofthe population at risk for head injury,children’s helmets sold on the markettoday generally are designed to meet theattenuation and absorption criteriaestablished for the adult helmeted-headform drop tests. The criteria fortesting and evaluating the performanceof helmets have been establishedprimarily on the basis of data derivedfrom injury tolerance studies conductedon adults. This is a matter of someconcern, since studies indicate that thetype of head injury resulting from blunt

trauma may differ significantly betweenadults and children.

The skull is the brain’s primaryprotection against blunt force trauma.The properties of the skull changesignificantly as a child matures. Cranialcapacity reaches adult size by 5 years ofage. At 18 months, the brain hasattained almost 70% of its adult sizeand, by 5–8 years, it is 90% of adultsize.

Most of the head growth beyond thefirst 5 years involves hardening of theskull and thickening of the soft tissuearound the brain. Children appear to beat greater risk of diffuse brain injurybecause their skulls have a lower degreeof calcification, which provides areduced capacity to absorb an impact.This results in a greater transfer of thekinetic energy from the impact site tothe brain tissue.

The differences in the type of headinjuries sustained by children andadults should have some bearing onhelmet design. Currently, nocompensation has been made for thedifferences between adults and childrenin head injury tolerance levels regardingthe bending strength of the skull.

Current United States bicycle helmetvoluntary standards recommend thathelmets limit an attenuation impact tobelow 300 g in order to reduce the riskof severe injury. However, for thereasons described above, this may beinadequate to protect children.Published reports have suggestedreducing the g-value for children from300 g to 150 to 250 g.8

A helmet may partially compensatefor the flexibility of a child’s skull.However, the interior dimensions of thehelmet will not perfectly fit the skull. Inan accident, point contact is likely tooccur between the skull and the helmet,which will tend to flex the child’s skullmore than an adult’s. Accordingly, theCommission concludes that adifferential in the g criteria is neededbetween adults’ and children’sstandards. The Commission proposes tolower the g-value to 250 g. This willprovide a substantial extra margin ofsafety to account for the increasedflexibility of children’s skulls, withoutmaking the criterion so stringent that itis either not cost effective or results inhelmets that are so heavy or bulky thattheir use would be discouraged.

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9 Mohan D, Bowman B, Snyder RG, and Frost, DR.A Biomechanical Analysis of Head Impact Injuriesto Children. J. Biomechanical Eng. 101, pp. 250–260, U.S., Nov. 1979.

Comment: Drop mass. Severalcommenters favored a variable dropmass instead of the originally proposed5 kg drop mass, which would have beenused for testing both adults’ andchildren’s helmets. (The helmet’s massis not included in the drop mass.) Somerespondents felt a reduced drop mass isespecially important for testing youngchildren’s helmets. One respondentopposed lowering the drop mass, statingthat there is no benefit in different dropmasses for each headform.

Response: A 1979 study found that inhead-first free fall, a child’s body massand orientation at impact have littleinfluence on head loading (g-forces)during impact.9 The study also explainsthat head loading in adult falls isinfluenced by a more complexrelationship between head mass andbody mass. This suggests that the actualhead mass of a child is an importantfactor in determining head loadingduring impact.

The helmet liner is designed to absorbthe energy of impact by deformation,and to deform at force levels below thatwhich would cause head injury.However, children’s heads have lessmass and their skulls are more flexiblethan those of adults. Therefore, a child’shead may not deform the helmet’s foampadding during impact if the foam isdesigned to protect the heavier adulthead. This lack of deformation mayresult in greater kinetic energy beingtransferred to a child’s brain, possiblyresulting in a greater likelihood ofintracranial injury. This stronglysuggests that children’s helmets shouldbe tested with a lower headform massthan helmets for adults.

The Commission’s Directorate forEpidemiology and Health Sciencesconcluded that the head mass ofchildren under the age of 5 years rangesfrom approximately 2.8 to 3.9 kg.Accordingly, the Commission isproposing a reduced drop assemblymass of 3.90 kg±0.1 kg for testinghelmets for children under 5. The lowermass will better represent the head massof children under 5 years of age than the5 kg mass specified for testing helmetsfor older children and adults.

Testing helmets for children under 5years with a more appropriate massshould lead to helmets that are betterdesigned to accommodate maturationaldifferences of a young child’s head. Aneven lower mass is not feasible withcurrent test rigs, because a dropassembly mass of less than 3.90 kg

would shift the center of gravity oncurrent test equipment enough topotentially influence test results.

Comment: Extent of protection.Current U.S. voluntary bicycle helmetstandards, and the originally proposedCPSC standard, specify an extent-of-protection boundary and an impact testline. The extent-of-protection boundarydefines the area of the head that mustbe covered by the helmet. The impactline designates the lowest point on thehelmet where the center of the anvilmay be aligned for testing. A clearanceis specified between the extent-of-protection boundary and the impact lineto allow for the imprint of the test anvil.

A number of comments on theproposed standard concerned theextent-of-protection (or extent ofcoverage) requirements. One commenterstated that the extent-of-protectionrequirement was subjective since no testis applied in these areas. Somecommenters believed the proposedextent-of-protection requirement wasdesign-restrictive, since some helmetshave features like rear vents that mayrise above the extent of coverage linebut nevertheless will provide protectionif impacted on the test line.

Response: The Commission believesthat a performance test using a singletest line and no extent-of-protectionrequirement is adequate for testing theimpact-attenuation capabilities of ahelmet. Not requiring specific helmetcoverage allows manufacturers theflexibility to include desirable featuressuch as a central rear vent, provided thefeatures do not hinder the helmet’sability to meet the impact requirementsif tested anywhere on or above the testline. Accordingly, the Commission hasdeleted the extent-of-protection linefrom the revised proposed standard.

Comment: Extended coverage foryoung children’s helmets. A number ofcommenters favored an extended area ofcoverage for young children’s helmets.However, one commenter suggested thatthe coverage lines defined in the firstCPSC-proposed standard were notpractical, since portions of the test lineextended lower than the edge of animpact headform.

Response: As noted above, youngchildren’s skulls lack the calcification ofolder children’s and adult skulls. This isespecially true of children under 5 yearsold, where the curve of head growth andskull development is steepest. Thetemporal region (area above and aroundthe ear) is much thinner than other partsof the skull. As a result, a much smallerforce at the temporal region can causea serious injury than at other regions ofthe skull. Accordingly, the Commissionconcludes that helmets for children

under 5 years should have a greater areaof protection than those for olderchildren and adults.

A recent proposal for infant helmettest lines by the ASTM HeadgearSubcommittee Infant/Toddler WorkingGroup specifies a ‘‘two-step’’ test linethat is measured directly from thereference plane of the ISO A and ISO Eheadforms. The Commission considersthe proposed ASTM test lineappropriate for testing helmets forchildren under 5 years. The revised testline (Figure 5) provides an increasedarea of protection, including thetemporal area.

Many young children’s helmets on themarket already provide an area ofprotection comparable to the revisedCPSC proposal, though it is not requiredby any current U.S. bike helmetstandard. The revised CPSC test line iseasier to define and mark on a helmetthan the first proposed CPSC line,which was referenced from an adjustedbasic plane inclined 15 degrees fromhorizontal. This new test line does notextend lower than the edge of theheadform.

Comment: Determining whichhelmets are for young children. Acommenter asked for clarification ofhow to determine whether helmets are‘‘intended’’ for children 4 years andunder. The concern is that smallhelmets are often sold to adults withsmall heads.

Response: Typically, helmets forchildren are advertised and promotedwith children’s themes. TheCommission will consider relevantfactors, such as the design andmarketing of a helmet, to determinewhether it is intended for youngchildren.

However, it is also important thatconsumers not mistake adult and olderchildren’s helmets that are the same sizeas helmets for children under 5 years ofage as complying with the extracoverage and other special provisionsrequired for helmets intended forchildren under 5. Therefore, theproposal provides that helmetsspecifically designed for children under5 years of age be labeled to read:‘‘Complies with CPSC Safety Standardfor Bicycle Helmets for Children Under5 years.’’

Comment: Peripheral vision. Onecommenter recommended revising theperipheral vision requirement to specifyclearances of two separate 105° arcsfrom the center of each eye.

Response: The existing requirement of105° clearance from the central point Kis an established criterion that providessufficient peripheral vision and allowsfor helmet protective coverage to the

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temporal area of the head. The proposedcriterion is consistent with ANSI,ASTM, and Snell bicycle helmetstandards, and with the FMVSS 218motorcycle helmet standard. Therefore,the Commission makes no change to theproposed rule in response to thiscomment.

Comment: Vertical vision. Onecommenter suggested that theCommission adopt requirements for avertical field of vision.

Response: The Commission has noinformation to indicate that bicyclehelmets are posing a risk of injury dueto inadequate upward or downwardvisual clearance. Accordingly, theCommission is not proposing a verticalfield of vision requirement.

Comment: Dwell time. Severalcommenters disagreed with the dwelltime specification in the first proposedCPSC standard.

Response: The Commission agreeswith these comments, and the impactattenuation requirements are revised tospecify only peak g as the evaluationcriteria. This change was made becauseof a lack of scientific evidence tosupport application of dwell time as abike helmet evaluation criterion.

Comment: Point loadingrequirements. Two commentersrecommended that the Commissionexplore requirements to limit localizedloads on the head that could be causedby strategically located high-densityfoam in helmet liners.

Response: The Commission has noinformation to indicate that somehelmet designs may pose a risk of injurydue to localized loading. Therefore, theCommission is not adding point loadingrequirements to the proposed rule atthis time.

Comment: Daytime and nighttimeconspicuity. Some comments related topossible requirements for helmets toimprove a bicyclist’s conspicuity inboth daytime and nighttime conditions.

Response: Available data do notsuggest that requirements to increase thevisibility of bicyclists to others wouldsignificantly reduce daytime incidents.Data do show an increased risk of injurywhile bicycling during non-daylighthours.

Commission staff observed informaldemonstrations which suggested thatreflective material on bike helmetscould enhance the conspicuity of anighttime rider. However, at this time,the Commission lacks information onwhat requirements might be effective toachieve this goal.

The Commission intends to study thisissue further in conjunction withplanned work on evaluating the bicyclereflector requirements of CPSC’s

mandatory requirements for bicycles. 16CFR part 1512. After that work iscompleted, the Commission will decidewhether to propose reflectivityrequirements for bicycle helmets underthe authority of the Children’s BicycleHelmet Safety Act of 1994. TheCommission does not intend to delayissuance of the standard proposed inthis notice to coincide with anyreflectivity requirements that may beissued later.

Comment: Type of test rig. Theoriginally proposed CPSC standard andthe current interim mandatory standardsallow the use of either a wire- or rail-guided impact test rig. A commenterrecommended that the Commissionadopt a free-fall test rig that has no rigidconnection between the headform andthe guide system. The Commission alsoreceived a proposal from onerespondent to evaluate differencesbetween twin-wire and monorail testrigs through exhaustive comparisontesting.

Response: The Commission has noinformation to indicate that thesuggested free-fall rig provides a morereliable test system or that it representsthe dynamics of a human headimpacting a surface better than othertypes of impact test equipment.Accordingly, the Commission is notproposing a free-fall test rig.

To avoid the possibility that differentresults would be obtained with the twotypes of test rigs, the Commission isspecifying only the monorail test rig inthe revised mandatory standard. Thesuggested tests would be helpful only ifboth test rigs were permitted.

For helmet certification testing, theregulation does not require that themanufacturer follow specifically theprocedures of the CPSC standard. Thus,a manufacturer may chose to certifyhelmets by testing with a wire-guidedtest rig, provided the manufacturerassures that the helmets will meet therequirements of the CPSC standardwhen tested on the standard’s monorailtest rig.

Comment: Dynamic strength ofretention system test—spinning rollers.A comment suggested that the ‘‘jawrods’’ in the strength of retention systemtest rig should be rotatable.

Response: The requested feature isconsistent with provisions in both theANSI and Canadian standards andshould help ensure that the maximumloading is transmitted to the retentionsystem attachment points. Accordingly,the Commission has adopted thissuggestion, and the revised proposalstates that the ‘‘stirrups’’ that representthe bone structure of the jaw shall befreely spinning cylindrical rollers.

Comment: Dimensions of impact base.Three commenters recommendedrevising the standard to allow a smallerimpact base. The commenters claimedthat the dimensions specified in theproposed standard are not consistentwith many existing test rigs.

Response: The Commission concludesthat there is no known reason to excludebases with smaller surface dimensions.Therefore, the Commission proposes toreduce the minimum surface areaspecification from 0.30 m2 to 0.10 m2.This is consistent with impact basespecifications in Snell helmet standards.The minimum mass of the impact basewill still be the originally proposed 135kg.

Comment: Instrument system checkprocedure. One commenter claimed thatthe instrument system check procedurespecified in the first proposed rule onlytests repeatability and not the accuracyof calibration. The commenterrecommended that the procedure allowusing a test headform, instead of thespherical impactor, for the instrumentsystem check impacts. The commenteralso suggested that the instrumentsystem check be performed at least oncea week.

Response: The commenter is correctthat this instrument system checkprocedure primarily indicates that thetest is producing repeatable results. TheCommission’s staff, using theprocedures proposed in the originallyproposed CPSC standard, obtained dailytest results on an average of 12 drops ofa spherical impactor on a modularelastomer programmer (‘‘MEP’’) pad for3 months. These tests yielded peakaccelerations that met the originallyproposed 389±8g criteria for thespecified velocity range. The specific g-level that will be achieved depends onthe MEP pad in use.

The Commission agrees that theinstrument system check procedureshould have greater flexibility to allowother laboratories to conduct testingbased on their internal procedures. Tohelp assure that consistent, reproducibledata are obtained, the Commissionproposes to continue the use of animpactor with a spherical impactsurface, rather than impact headforms.The Commission also believes that thesystem check interval should not belonger than the beginning and end ofeach test day. The revised procedure,however, is not intended to preventeach laboratory from exercising soundengineering practice in establishingtheir specific methodology.

Comment: Distance between impacts.A commenter recommends revising theminimum distance between impact sites

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from ‘‘one fifth the circumference of thehelmet’’ to 120 mm.

Response: The Commission believesthat 120 mm allows sufficient distanceto minimize the effects of impact siteproximity and provides a morestraightforward measurement than theoriginal one-fifth circumference criteria.Accordingly, the Commission proposesto adopt this recommendation.

Comment: Impact velocity tolerance.One commenter suggested a changefrom ±2% to ±5% for the tolerance onimpact velocity.

Response: Tests by CPSC staffindicated that helmet impact velocitiessometimes fell outside the proposed±2% tolerance. However, the impactvelocities almost always were within±3% of the specified value. These testsshowed that a ±3% velocity tolerance isreasonable to maintain a test procedurethat will reliably indicate the equipmentis functioning properly. Accordingly,the velocity tolerance for helmet testinghas been changed to±3% in the revised proposal.

Comment: Number of helmetsrequired for testing. Comments weresubmitted requesting clarification of thenumber of helmet samples needed ifattachments are provided with thehelmet and if the helmet fits twoheadform sizes.

Response: An additional set of fivehelmets is needed for each additionalattachment (e.g., visors or shields), orcombinations thereof, sold for use withthe helmet. Two additional samples perset are needed if the helmet fits twoheadform sizes.

Comment: Fit and testing. A commentstated that the standard needed todefine ‘‘fit’’ as it relates to the processof selecting a test headform. Anothercomment provided a definition of ‘‘fit’’and suggested that the language forselecting a test headform should moreclearly explain how a sample set ofhelmets is divided when a helmet fitstwo different headform sizes.

Response: Language addressing theseconcerns, including a definition of ‘‘fit,’’has been added to the revised proposedrule.

Comment: Wet-conditioning. Anumber of commenters suggested thatwet-conditioning by totally immersingthe helmet in water is unrealisticallysevere. These commentersrecommended that the Commissionconsider a water-spray environment.

Response: Commission testing of bothimmersed and water-sprayed helmetsunder various time durations showed noconsistent trend in resulting peakacceleration levels. The immersionenvironment has the advantages ofbeing easier to define and of subjecting

the helmet to a uniform conditioningexposure. Since testing showed thatthese commenters’ concerns areunfounded, the Commission is retainingthe immersion method of wet-conditioning in the proposed standard.However, additional specifications tostandardize the wet environment areincluded.

Comment: Anvil test schedule. In theoriginally proposed standard, helmets 1through 4 would have been tested withthe flat and hemispherical anvils andthe fifth helmet would be tested withthe curbstone anvil. Two commenterssuggested that there is no reason for acurbstone anvil impact to be treateddifferently from the flat andhemispherical anvil impacts.

Response: Each anvil has a unique‘‘imprint’’ that could stress helmetdesigns differently. Therefore, theproposed standard has been revised sothat each of test helmets 1 through 4must meet the standard’s impact criteriaon four impacts, once with each of thethree anvils and once with the anvillikely to result in the highest g-value. Inthe absence of an indication whyanother anvil would be more stringent,this fourth impact should be made withthe anvil that produced the highest g-value in the previous three impacts.This is consistent with the testschedules of the Snell B–90(S), N–94,and B–95 helmet standards. (Under therevised proposal, the fifth helmet istested only for positional stability.)

Comment: Helmet straps. Acommenter recommended that the testprocedure require that all slack beremoved from the helmet straps whenfastening the helmet to the testheadform.

Response: The Commission agreeswith this comment and has revised theproposal accordingly.

Comment: Lateral positional stabilitytest. A commenter recommended theaddition of a positional stability test inthe lateral direction.

Response: The shape of the head issuch that a properly fitted helmet ismore likely to come off to the front orrear than to the side. Accordingly, thesuggested lateral positioning test isunnecessary and not proposed.

Comment: Dynamic v. static-loadpositional stability test. One commentersuggested that the CPSC consider thestatic load positional stability testspecified in the Canadian StandardsAssociation (’CSA’) bicycle helmetstandard.

Response: The Commission believesthat a dynamic test provides a morerigorous and realistic test of the restraintsystem, and has not adopted thissuggested change.

Comment: Retention system testschedule. Some commenters asked thatthe CPSC consider a change to the testschedule so that at least one impactattenuation drop per sample would beperformed prior to testing the retentionsystem.

Response: CPSC staff testing did notshow evidence to warrant a change inthe sequence of retention systemstrength tests and impact tests.Accordingly, the Commission did notmake this suggested change.

Comment: Use of a Rubber Pad on theStop Anvil. One commenterrecommended using a rubber padbetween the steel drop mass and thestop anvil.

Response: The current ASTM andANSI bicycle helmet standards do notrequire a rubber pad on the stop anvil.Based on comparison testing with andwithout a rubber pad, the Commissionbelieves a rubber pad may produce asomewhat less stringent test. In theabsence of any compelling reason toallow a rubber pad, therefore, theCommission has not changed theoriginal proposal in this regard.

Comment: Self-release buckle. Onecommenter suggested that considerationbe given to requirements for a self-release buckle that could be used toprevent strangulation if the helmetbecomes caught. The commenter statedthat there are now efforts in Europe todevelop a test method that wouldensure that buckles release or breakaway when subjected to a loadequivalent to the weight of a child.

Response: The Commission hasreceived reports of eight or nine deathsof children in Sweden and Norway thatoccurred when helmets became caughtin trees or playground equipment,causing the child to become suspendedby the chin strap. The Commission alsohas received reports of four nonfatalincidents in the United States since1990, involving children of ages from 5through 7 years, that occurred in thesame fashion.

However, the Commission is notproposing requirements for a self-releasebuckle at this time. Considering thefrequency and potential severity of headinjuries in bicycle accidents, it isimportant to ensure that the helmetretention strength requirements are notcompromised.

Comment: Use labeling. A number ofcomments concerned what informationshould be on a bike helmet label toinform consumers of the helmet’sintended use. Some commenters favoredthe ‘‘Not For Motor Vehicle Use’’ labelthat was first proposed in the CPSCstandard. Others felt the helmet shouldbe labeled ‘‘For Bicycle Use Only.’’

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10 In fact, despite the ‘‘For bicycle use only’’ label,the U.S. Amateur Confederation of Roller Skatingadopted the ANSI and Snell helmet standards yearsago for use in competitive roller skating.

Response: Currently, the ANSI andSnell voluntary standards require thelabel ‘‘For Bicycle Use Only.’’ ASTMrequires the label ‘‘Not for MotorVehicle Use.’’ The ASTM label wasoriginally proposed because helmets arecurrently not made specifically formany non-bicycling activities, andpeople should not be discouraged fromusing a helmet for such activities by alabel that states it is for bicycle useonly.10

Other commenters, however,disagreed. One indicated that labeling‘‘Not for Motor Vehicle Use’’ wouldstifle the development of separatehelmet standards for other sports byvoluntary organizations. The commenterbelieved that the ‘‘Not for Motor VehicleUse’’ label suggests that a bicycle helmetis as effective for any non-motorized useas a helmet designed specifically forthat activity.

The Commission has no evidence tosupport the contention that the ASTMlabel would inhibit the development ofvoluntary standards for non-motorizedactivities, and no evidence that a bicyclehelmet is inadequate for some of theseactivities. For this reason, theCommission continues to propose theASTM label, ‘‘Not for Motor VehicleUse.’’

Comment: Label language and format.Some commenters suggested that thelabels have specific language and format(e.g., the ANSI Warning Format).

Response: The Commission concludesthat requiring specific language orformat is inappropriate for bicyclehelmet labels, because the variety ofhelmet styles and limited space on theinterior of some helmets requires moreflexibility in labeling.

Comment: Fit information on box.One commenter recommended thatinformation on how to properly fit ahelmet be required on the outside of thebox.

Response: Children frequently reportuncomfortable fit as a reason for notwearing a helmet all the time. It isreasonable to expect that improper fitwas sometimes involved in complaintsthat helmets are uncomfortable. A labelon the box could inform parents, beforethey buy the helmet, that they need toproperly fit it to the child’s head.However, the Commission is not awareof any information which indicates thatsuch a label would be any moreeffective in assuring proper fit in usethan the originally proposedinstructions, which need not be on the

box. Accordingly, the Commission didnot adopt this requested change.

Comment: Age-specific fitinstructions. A commenter suggestedthat instructions on fitting a helmet beage-specific, so that a young child canread them.

Response: The Commission believesthat age-specific instructions areunnecessary. The Commission lacksdata showing that young children wouldact on age-specific instructions withouturging from their parents. The originallyproposed rule requires that theinstruction sheet have graphics showingproper fit and position of the helmet.Children who can read may well be ableto understand pictures showing properfit. If not, the involvement of parentswill likely be needed to convey theinformation on how to fit the helmet.Parents reading along with the child anddiscussing the pictures will likelydeliver the message of proper fit.

Comment: Life of helmets. Onecommenter was concerned that therequirement of § 1203.6(a) that labels belegible for the life of the helmet wasindefinite, because the life of a helmetis not known.

Response: Snell N–94 and B–95helmet standards recommend thathelmets be replaced after 5 years, or lessif the manufacturer so recommends. TheCommission concludes that themanufacturer or importer can determinethe life of a particular helmet and assurethat the labels will remain legible forthat time. However, to make thisrequirement more definite, theCommission has amended the proposalto state that the labels shall remainlegible for the intended design life of thehelmet.

Comment: Helmet label—post-impactinstructions. Some commentersrequested that more direct informationbe provided about what to do with ahelmet that has received an impact. Onerespondent stated that the currentwording—‘‘after receiving an impact,the helmet should be returned tomanufacturer or be destroyed andreplaced’’—is ambiguous.

Response: Damage to a helmet froman impact is not always visible to theuser. To describe on a label thecircumstances in which helmets can beused again, can be fixed, or should bedestroyed, if feasible at all, would makethe label excessively wordy and likelyto be skimmed or ignored. Therefore,the Commission concludes that the mostspecific and appropriate label wouldstate that the helmet be returned to themanufacturer or destroyed after impactbecause any damage may not be visibleto the user.

Comment: Neck injury protection.One commenter requested that theCommission include in this FederalRegister notice a statement encouraginghelmet manufacturers to ‘‘undertake thedevelopment and marketing of helmetsthat protect wearers from paralyzingneck injuries as a result of bicycleriding.’’ The commenter referred to areport that indicates that bike helmetsreduce the risk of head injury, but donot seem to have any effect in reducingthe risk of serious neck injury.

Response: The Commission is awareof some efforts to reduce the risks ofserious neck injury to bicyclists andparticipants in other recreationalactivities. The Commission alwaysencourages research and development ofsafety-related devices. TheCommission’s staff will continue tomonitor progress in this area. However,such devices are beyond the scope ofthis proceeding.

Other changes to the standard:1. Impact-attenuation test—support

assembly mass. The specification thatthe mass of the support assembly be nogreater than 25 percent of the mass ofthe total drop assembly has beendeleted. The boundary on the locationfor the center of gravity at§ 1203.17(a)(3) will adequately limit themass variance between the supportassembly and the headform assembly.

2. Dynamic strength of retentionsystem test—mass of the test rig. TheASTM F1446 standard specifies asupport assembly mass in the range of6 kg to 12 kg (including the drop mass).CPSC considered this range too widewhen developing the first CPSCproposed standard and specified a massof 6 kg with a tight tolerance of ± 0.5kg. Subsequent consideration of thisissue by the ASTM HeadgearSubcommittee concluded that theassembly mass, excluding the dropweight, should be specified at 7 kg (11kg including the drop weight) with anarrow tolerance. It was agreed that thisrig applies a rigorous test of retentionsystem strength and provides a systembetter suited for adapting an electronicdisplacement transducer to provide anaccurate means for measuringelongation. Accordingly, the mass of thetest rig has been revised to 11 kg ± 0.5kg.

3. Dynamic strength of retentionsystem test—deletion of preload ballastprocedure. The procedure to place apreload ballast on top of the helmet hasbeen deleted, since the more massivetest rig in the revised proposal appliesa sufficient preload to the helmetretention system to set the helmet fitpadding against the test headform.

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4. Children’s helmets—age range. Theage break for special provisions forchildren’s helmets was originallyproposed for ‘‘children 4 years of ageand under.’’ The Commission hasrevised this language to ‘‘children under5 years of age.’’ This language clarifiesthe intent to include children until theyreach their fifth birthday.

5. Older children and adults test line.The Commission is proposing a revisedtest line for adults’ and older children’shelmets, as shown in Figure 4. Theportion of the test line that extends fromthe front of the headform and throughits center portion is essentially the testline specified in the Snell B–90standard. Compared to the test lines inother U.S. voluntary bike helmetstandards to which bike helmets arecurrently certified, the Snell B–90 testline provides the greatest area of impactprotection in the front and centralportions of the head.

The rear step in the revised CPSC testline is derived by using a 20 mmclearance from the extent-of-protectionboundary specified in the August 15,1994, CPSC-proposed bike helmetstandard. The revised test regionprovides an acceptable area of headprotection while allowing for certaindesign flexibility.

6. Definition of Helmet PositioningIndex (‘‘HPI’’). In the originallyproposed standard, the HPI is defined asa distance that locates where the browof the helmet should be positioned onthe headform. In the revised proposal,the HPI is defined (§ 1203.4(f)) to be aspecified distance from the referenceplane (defined at § 1203.4(l) and Figure3), rather than from the basic plane(defined at § 1203.4(a) and Figures 1 and2). This change is made because impactheadforms are cut away (above the basicplane) at the front brow area, making itdifficult to measure for the HPI from thebasic plane.

D. Certification Testing and LabelingGeneral. 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‘‘reasonable testing program.’’ Subpart Bof the proposed Safety Standard forBicycle Helmets contains thesecertification requirements.

The originally proposed certificationrule. The proposed certification rulewould require manufacturers of bicyclehelmets that are manufactured 1 yearafter the issue date of the final standard

to affix permanent labels to the helmets.These labels would be the ‘‘certificatesof compliance,’’ as that term is used in§ 14(a) of the CPSA. In the rule asoriginally proposed, all helmets wouldhave had a label stating ‘‘Complies withCPSC Safety Standard for BicycleHelmets (16 CFR 1203)’’. As explainedbelow, the Commission is proposingsomewhat different language for thislabel.

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, it is proposed to adviseconsumers that the helmet meets theCPSC standard by a second label thatwould be on the helmet’s container or,if the container is not visible, on thepromotional material used inconnection with the sale of the bicyclehelmet.

The proposed certification label alsocontains the name and address of themanufacturer or importer, and identifiesthe production lot and the month andyear the product was manufactured.Some of the required information maybe in code.

The proposed certification rulerequires manufacturers and importers toconduct a reasonable testing program todemonstrate that their bicycle helmetscomply with the requirements of thestandard. This reasonable testingprogram may be defined by themanufacturers, but must include eitherthe tests prescribed in the standard orany other reasonable test proceduresthat assure compliance with thestandard.

The originally proposed certificationrule provides that the required testingprogram will test bicycle helmetssampled from each production lot insuch a manner that there is a reasonableassurance that, if the bicycle helmetsselected for testing meet the standard,all bicycle helmets in the lot will meetthe standard.

The rule as originally proposedprovided that bicycle helmet importersmay rely in good faith on the foreignmanufacturer’s certificate ofcompliance, provided that a reasonabletesting program has been performed byor for the foreign manufacturer; theimporter is a U.S. resident or has aresident agent in the U.S.; and therequired test records are kept in the U.S.As explained in section E below, theCommission proposes an exception tothe requirement that test records mustbe kept in the U.S.

Comments, responses, and otherchanges to the certification testing andlabeling requirements.

Comment: Production lot. Onecommenter stated that the rule shoulduse ‘‘frequency of production’’ ratherthan the originally proposed‘‘manufacturing lot’’ method to define alot. The commenter explained that amanufacturing lot may encompass wellover a million helmets if there are nochanges in the design and production ofa helmet. The commenter furtherexplained that using frequency ofproduction as the basis of the requiredreasonable testing program wouldrequire a firm to test after a specifiednumber of helmets are produced. Thecommenter believes this would catchany defects more readily.

Another commenter stated that theproduction lot should be based on amonthly or yearly period, as aproduction lot could include helmetsmade well after the qualification testing.

Another commenter stated that theproposed definition of a production lotis unmanageable and may be expensiveif a large number of helmets is producedand if there are any variations in thematerials or processes in the productionof the helmets. The commenterrecommends that the definition ofproduction lot be changed to either‘‘sequentially labeled helmets bondedand tested separately, or a continuousproduction of like models produced inaccordance with a quality systemensuring traceability for all componentparts.’’ Comment CC94–2–25.

In addition, a commenter stated thatCPSC should allow manufacturersflexibility to establish their ownrecognized quality assurance program,such as Mil Std 105D, ISO 9000, orASQC.

Response: The proposed rule definesa ‘‘production lot’’ as ‘‘a quantity ofbicycle helmets from which certainbicycle helmets are selected for testingbefore certifying the lot.’’ In theproposed regulation, the helmets in a lotmust be essentially identical in design,construction, and materials. Thisdefinition of a production lot does notrequire the lot to be a specified numberof helmets or a set time interval ofhelmet production, such as weekly ormonthly. However, the definition in theproposed regulation does not prohibitcertification based on testing after aspecified number of helmets or periodof time, provided that changes in thedesign, construction, or materials of thehelmet are not made in that productionlot. Firms must define their productionlots in such a fashion that samplescollected for testing represent all thebicycle helmets in a particular lot.

The firms responsible for certificationknow their products and manufacturingprocesses. These firms are in the best

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position to define their production lotand set up a reasonable testing programin order to assure that their helmetsmeet the standard. Furthermore, testingon only a number or time basis couldallow changes in the helmets’specifications during a production lotthat might cause failing results to goundetected until the specified intervaloccurs. Accordingly, the Commission isnot proposing to require testing after aspecified number of helmets or timeperiod of production.

A firm is not restricted in any wayfrom establishing its own quality controlprogram, including programs based onMil Std. 105D, ISO 9000, or ASQC.Therefore, no change in the proposal isrequired in this regard.

The Commission believes that thecertifying firms can determine, based ontheir production lot and methods ofmanufacture, how best to sample theirlot in order to insure that the helmetsmeet the standard.

Comment: Sampling. A commenterstated that the testing program shouldprovide for sampling over the entireproduction lot in order to discover theproduction of noncomplying helmets.

Response: Under the proposed rule,there is no requirement that sampling beconducted over the entire productionlot. The rule states that themanufacturers and importers may set uptheir own testing program, provided theprogram is reasonable. The testingprogram is to insure that the helmetsselected for testing represent all thehelmets in the production lot. For theguidance of certifying firms, however,the Commission notes that a reasonabletesting program would include bothprototype and production testing, toprovide reasonable assurance that all ofthe bicycle helmets in the productionlot being tested comply with therequirements of the standard.

Comment: Certification label. Acommenter inquired whether thecontent of the certification label couldbe divided among more than one label.

Response: The originally proposedregulation did not address whether theplacement should be on one label.However, the restricted space insidehelmets requires that there be flexibilityfor the format of the certificationlabeling.

The Commission’s Division of HumanFactors believes that the name andaddress of the manufacturer, privatelabeler, or importer, where required andnot in code, should be on one label.This is so the consumer can associatethe address with the name if it isnecessary to contact the manufacturer,private labeler, or importer for repair orreplacement of the helmet. Also, if it is

too difficult to find the information,consumers are less likely to followthrough with repair or replacement ofhelmets. Accordingly, the Commissionis revising the proposal to require thatthe name and address of firms requiredto be identified uncoded on the labelmust be on the same label.

However, the Commission nowproposes to allow separate labels for theother required information, includingthe statement of compliance with theCPSC standard, the production lot, andthe date of manufacture.

Comment: Third-party testing. Acommenter suggested that certificationtesting should be conducted by a thirdparty and include off-the-shelf randomtesting.

Response: Under the proposed rule,testing may be done by themanufacturer or importer or by a thirdparty. Regardless of who performs thetest, certifying firms are responsible forinsuring compliance with allrequirements of the standard. No dataare available showing that third-partycertification would improve compliancewith the standard. Accordingly, there isno reason to change the proposal in thatregard.

Comment: Verification by CPSC. Acommenter suggested that the qualitycontrol testing program, testingequipment, and calibration of the testingequipment should be verified by CPSC.

Response: It would be an inefficientuse of Commission resources to conducteither quality control verification orcalibration of industry equipment, andthe need to do this has not beendemonstrated. Accordingly, theproposal is unchanged in this regard.

Comment: Production testing offeatures unlikely to change. Acommenter stated that, once a model iscertified, testing of helmets forperipheral vision, labeling, andinstructions are unnecessary whenperforming routine compliance testing.

Response: The proposal allows eachfirm to establish its own testingprogram, provided the testing programis reasonable. No specific tests arerequired. When there have not been anychanges in the design of the helmet, thefirm may establish simple visualexamination of some attributes ofhelmets. For example, if themanufacturer is assured that there hasbeen no change in the physicaldimensions of a helmet, there would beno need to retest the helmet’s peripheralvision.

No change to the proposal is requiredto accommodate this commenter’sconcern.

Comment: Certification labelcontent—coding of foreign

manufacturer. A commenter complainedthat the true name of the foreignmanufacturer could be coded and notdisclosed.

Response: The intent of thecertification label is to identify a partythat the consumer or the CPSC cancontact concerning the safety of ahelmet. In addition, consumers need tobe able to contact someone in the U.S.for repair or replacement information.Since foreign manufacturers are notsubject to this regulation, there is noneed for consumers to know the identityof the foreign manufacturer.Accordingly, the importer may code theforeign manufacturer’s name. Similarly,a private labeler may code the U.S.manufacturer or both the importer andforeign manufacturer.

The identification of the codedinformation must be available uponrequest from the importer or privatelabeler whose name is required toappear on the certification label. Thisadequately protects the interests theconsumer and the CPSC have in thisinformation. In addition, consumerscould be confused if two firms wereidentified on the label. Accordingly, nochange to the proposal is made in thisregard.

Comment: Certification labelcontent—age of helmet. A commenterstated that permitting the coding of theproduct lot number and the date ofmanufacture denies consumersimportant information on the age oftheir helmets, as manufacturerscommonly recommend replacing thehelmet after 5 years. The commentercontends also that it would be easier forconsumers to recognize recalls ofhelmets identified by dates on thehelmets rather than by other codes.

Response: Under the proposed rule,the manufacturer, importer, or privatelabeler may code the production lot andthe date of production. These codes onthe helmets should not place an undueburden on the consumer in determiningthe date of manufacture, as thisinformation can be obtained ifnecessary.

Manufacturers recommend thathelmets be replaced after 5 years of use.The manufacture date or code wouldnot identify the ‘‘use’’ age of the helmet,which relates more to the date ofpurchase of the helmet.

During recalls, the affected firms willidentify the model of the helmet, anycodes, where it was sold, and the datesof distribution. A consumer can readilyascertain if his/her helmet is beingrecalled by examining the modelnumber and the date of manufacture,which may be coded. Having themanufacturing date coded would not

62672 Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Proposed Rules

interfere with identifying a recalledhelmet. Accordingly, no change in theproposal is needed in this regard.

Comment: Certification labelcontent—date of manufacture, serialnumber, and test date. One firm wantsto provide the date of manufacture,serial number, and test date on thehelmet, rather than a production lot.

Response: The proposed regulationrequires the production lot and themonth and year of manufacture to beidentifiable from the label, but does notrequire or prohibit the serial number ortest date. Both the production lot andthe time of manufacture may be in code.The test date would not add anyinformation for the consumer. The serialnumber, however, may serve as a codeto identify the production lot and, if so,may be used in its place.

Accordingly, the proposed rule hasbeen revised to state that a serialnumber may be used in place of aproduction lot identification if it canserve as a code to identify theproduction lot.

Comment: Certification labelcontent—telephone number. Acommenter contends that the telephonenumber of the responsible firm shouldbe on the certification label.

Response: A telephone number is notrequired. This might place a burden onsmall firms with insufficient staff tohandle a large number of calls. Theconsumer can contact the responsiblefirm in writing if the need arises.

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

The Commission wants to guardagainst the possibility that small adulthelmets will be purchased for children.Therefore, the revised proposedstandard requires that helmets that donot comply with the requirements foryoung children’s helmets be labeled‘‘Complies with CPSC Safety Standardfor Bicycle Helmets for Adults andChildren Age 5 and Older (16 CFR1203)’’. Helmets intended for children 4years of age and younger would bear alabel stating ‘‘Complies with CPSCSafety Standard for Bicycle Helmets forChildren Under 5 Years (16 CFR 1203)’’.Helmets that comply with bothstandards could be labeled ‘‘Complieswith the CPSC Safety Standard forBicycle Helmets for Persons of AllAges’’, or equivalent language.

E. RecordkeepingSection 16(b) of the CPSA requires

that: [e]very person who is amanufacturer, private labeler, ordistributor of a consumer product shallestablish and maintain such records,make such reports, and provide suchinformation as the Commission mayreasonably require for the purposes ofimplementing this Act, or to determinecompliance with rules or ordersprescribed under this Act.15 U.S.C. 2065(b).

The rule as originally proposed wouldhave required every entity issuingcertificates of compliance for bicyclehelmets to maintain written records thatshow the certificates are based on areasonable testing program. Asexplained below, the Commissionproposes to relax the requirement thatthe records be kept in written form.

These records were proposed to bemaintained for a period of at least 3years from the date of certification of thelast bicycle helmet in each productionlot and shall be available to anydesignated officer or employee of theCommission upon request in accordancewith § 16(b) of the CPSA, 15 U.S.C.2065(b).

Comment: 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. Acommenter inquired whether testrecords must be kept in the U.S. in thecase of a Canadian firm that is ownedby a U.S. firm, if the records areavailable to the U.S. company uponrequest.

Response: The situation described bythe commenter would achieve the resultdesired by the Commission.Accordingly, the Commission hasrevised the proposed regulation to statethat if the importer can provide therecords to the CPSC staff within the 48-hour time period, the records will beconsidered kept in the U.S.

Comment: Records on disk. Theproposed regulation stated that everyperson issuing a certificate ofcompliance for bicycle helmets shallmaintain written records that showcertificates are based on a reasonabletesting program. A commenter requestedthat the certification test records beallowed to be kept on disk instead ofpaper.

Response: The Commission agreeswith the commenter that firms shouldbe allowed to keep the records on disk,if the records can be made availableupon request in an appropriate format.Accordingly, the Commission has

amended the proposal to state thatcertification test record results may bekept on paper, microfiche, computerdisk, or other retrievable media. Whererecords are kept on computer disk orother retrievable media, the recordsshall be made available to theCommission upon request on papercopies, or via electronic mail in thesame format as paper copies.

F. Regulatory Flexibility ActCertification

When an agency undertakes arulemaking proceeding, the RegulatoryFlexibility Act, 5 U.S.C. 601 et seq.,generally requires the agency to prepareproposed and final regulatory flexibilityanalyses describing the impact of therule on small businesses and other smallentities.

The purpose of the RegulatoryFlexibility Act, as stated in section 2(b)(5 U.S.C. 602 note), is to requireagencies, consistent with theirobjectives, to fit the requirements ofregulations to the scale of thebusinesses, organizations, andgovernmental jurisdictions subject tothe regulations. Section 605 of the Actprovides that an agency is not requiredto prepare a regulatory flexibilityanalysis if the head of an agencycertifies that the rule will not have asignificant economic impact on asubstantial number of small entities.

The Commission’s Directorate forEconomics has prepared a preliminaryeconomic assessment of the safetystandard for bicycle helmets. Theproposed rule would establishperformance requirements for bicyclehelmets. The vast majority of helmetsnow sold conform to one (or more) ofthree existing voluntary standards. Theone-time costs associated with theredesign and testing of helmets to thenew performance standards are notknown. On a per-unit basis, however,costs associated with redesign andtesting are expected to be small. TheCommission solicits comment on thecosts of the redesign and testing ofbicycle helmets that would be requiredby the proposed standard.

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 proposed standard allowsfor self certification and monitoring,however, which is substantially lesscostly than third party testing andmonitoring.

The proposed labeling requirement isunlikely to have a significant impact onsmall firms, since virtually all bicyclehelmets now bear a permanent label ontheir inside surface. Industry sources

62673Federal Register / Vol. 60, No. 234 / Wednesday, December 6, 1995 / Proposed Rules

report that, given sufficient lead time tomodify these labels, any increased costof labeling would be insignificant.

Accordingly, for the reasons givenabove, the Commission preliminarilycertifies that the proposed SafetyStandard for Bicycle Helmets, ifpromulgated, will not have anysignificant economic effect on asubstantial number 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 has assessedthe possible environmental effectsassociated with the proposed safetystandard for bicycle helmets.

The Commission’s regulations at 16CFR 1021.5(c)(1) and (2) state that safetystandards and product labeling orcertification rules for consumerproducts normally have little or nopotential for affecting the humanenvironment. Preliminary analysis ofthe potential impact of this proposedrule indicates that the rule is notexpected to affect preexisting packagingor materials of construction now usedby manufacturers. Existing inventoriesof finished products would not berendered unusable, since section 9(g)(1)of the CPSA provides that standardsapply only to products manufacturedafter the effective date. Changes incoverage areas for helmets may requiremodification or replacement of existinginjection molds. However, molds areroutinely replaced due to wear or tochanges in style, and modified moldscould be incorporated in thisreplacement process. Thus, the quantityof discarded molds attributable to therule is likely to be small. Especially inview of the statutory 1-year effectivedate, it is unlikely that significant stocksof current labels would require 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 fromthe proposed rule if it is adopted.Accordingly, neither an environmentalassessment nor an environmentalimpact statement is required.

H. Paperwork Reduction ActAs noted above, the requirements

proposed below, if issued as a final rule,would require U.S. manufacturers andimporters of bicycle helmets to conducta reasonable testing program to ensuretheir products comply with the

standard. They are also required to keeprecords of such testing so that theCommission’s staff can verify that thetesting was conducted properly. Thiswill enable the staff to obtaininformation indicating that a company’shelmets comply with the standard,without having itself to test helmets.U.S. manufacturers and importers ofbicycle helmets would also have to labeltheir products with specifiedinformation.

For these reasons, the proposalpublished below contains ‘‘collection ofinformation requirements’’ subject tothe Paperwork Reduction Act of 1995,15 U.S.C. 3501–3520, Pub. L. 104–13,109 Stat. 163 (1995). An agency may notconduct or sponsor, and a person is notrequired to respond to, a collection ofinformation unless it displays acurrently valid OMB control number.The control number may be displayedby publication in the Federal Register.Accordingly, the Commission hassubmitted the proposed collection ofinformation requirements to OMB forreview under section 3507(d) of thePaperwork Reduction Act of 1995. Thetitle of the submission is ‘‘SafetyStandard for Bicycle Helmets—Testingand Recordkeeping Requirements.’’

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 advise theCommission’s staff that the time thatwill be required to comply with thecollection of information requirementswill be from 100 to 150 hours per modelper 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, the netburden of the proposed final collectionof information requirements is expectedto be insignificant, or at least a smallfraction of the total hours given above.The Commission would like to receivecomments on the activities and timerequired to comply with theserequirements and how these differ fromusual and customary current industrypractices, on the accuracy of theCommission’s burden estimate, and onhow that burden could be reduced.

It is possible that firms will considersome of the records required to beprovided to the Commission uponrequest to be trade secret or other

confidential commercial information.Under section 6(a)(2) of the CPSA, theCommission may not discloseinformation that contains or relates to atrade secret, or is of a type referred toin 18 U.S.C. 1905 or subject to 5 U.S.C.552(b)(4). 15 U.S.C. 2055(a)(2). Underthis section and 16 CFR 1015.18-.19,persons desiring confidential treatmentfor information must request that it notbe disclosed. If the Commission’s staffnevertheless determines that theinformation may be disclosed because itis not confidential, the personsubmitting the information will be givenwritten notice at least 10 working daysbefore the information is released. Thus,the submitter has an opportunity to seekjudicial review of the Commission’sdetermination before the information isreleased. Also, see 16 CFR part 1101.These procedures also apply torulemaking comments for which thecommenter seeks confidentiality.

Any person may also submitcomments to OMB on these proposedcollection of information requirements.OMB is required to make a decisionconcerning the collections ofinformation contained in the proposedrule between 30 and 60 days afterpublication. Thus, although commentswill be received by OMB until February5, 1996, a comment to OMB is bestassured of having its full effect if OMBreceives it by January 5, 1996.Comments should be submitted to theOffice of Information and RegulatoryAffairs of OMB, Attention: Desk Officerfor the Consumer Product SafetyCommission. Persons filing commentswith OMB are encouraged to sendcopies to the Commission’s Office of theSecretary, with a caption or cover letteridentifying the materials as commentssubmitted to OMB on the proposedcollection of information requirementsfor bicycle helmets.

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

Incorporation by reference, Infants andchildren, Safety.

For the reasons given above, theCommission proposes to revise Part1203 of Title 16 of the Code of FederalRegulations, to read as follows:

PART 1203—SAFETY STANDARD FORBICYCLE HELMETS

Subpart A—The StandardSec.1203.1 Scope and effective date.1203.2 Purpose.1203.3 Referenced documents.1203.4 Definitions.1203.5 Construction requirements -

projections.1203.6 Labeling and instructions.

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1 Available from American National StandardsInstitute, 11 W. 42nd St., 13th Floor, New York, NY10036.

2 Available from the Department ofTransportation, National Highway Traffic SafetyAdministration, Office of Vehicle Safety Standards,400 7th St. S.W., Washington D.C. 20590.

3 Available from Society of Automotive Engineers,400 Commonwealth Dr., Warrendale, PA 15096.

1203.7 Samples for testing.1203.8 Conditioning environments.1203.9 Test headforms.1203.10 Selecting the test headform.1203.11 Marking the test line.1203.12 Test requirements.1203.13 Test schedule.1203.14 Peripheral vision test.1203.15 Positional stability test (roll-off

resistance).1203.16 Dynamic strength of retention

system test.1203.17 Impact attenuation test.1203.18 Reflectivity. [Reserved]

Subpart B—Certification

1203.30 Purpose and scope.1203.31 Effective date.1203.32 Definitions.1203.33 Certification testing.1203.34 Product certification and labeling

by manufacturers (including importers).

Subpart C—Recordkeeping

1203.40 Effective date.1203.41 Recordkeeping requirements.

Subpart D—Bicycle Helmets ManufacturedFrom March 16, 1995, Through Date That Is1 Year After The Final Rule Is Issued

1203.51 Purpose.1203.52 Scope and effective date.1203.53 Interim safety standards.

Figures to Part 1203Authority: Secs. 201–207, Pub. L. 103–267,

108 Stat. 726–729, 15 U.S.C. 6001–6006.

Subpart A—The Standard

§ 1203.1 Scope and effective date.This standard describes test methods

and defines minimum performancecriteria for protective headgear used bybicyclists. The values stated inInternational System of Units (‘‘SI’’)measurements are the standard. Theinch-pound values stated in parenthesesare for information only. The standardshall become effective 1 year afterpublication of the final rule and shallapply to all bicycle helmetsmanufactured after that date. Bicyclehelmets manufactured between March16, 1995, and the date that is 1 year afterpublication of the final rule, inclusive,are subject to the requirements ofSubpart D, rather than this Subpart A.

§ 1203.2 Purpose.The purpose and basis of this

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

§ 1203.3 Referenced documents.The following documents are

referenced in this standard.

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

(b) Federal Motor Vehicle SafetyStandard 218, Motorcycle Helmets.2

(c) SAE Recommended Practice SAEJ211 OCT88, Instrumentation for ImpactTests.3

§ 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 to this part).

(b) Bicycle helmet means anyheadgear that either is marketed as, orhas a reasonably foreseeable use as, adevice intended to provide protectionfrom head injuries while riding abicycle.

(c) Comfort or fit padding meansresilient lining material used toconfigure the helmet for a range ofdifferent head sizes. This padding hasno significant effect on impactattenuation.

(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 thiscoronal plane (see Figures 1 and 2).

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

(f) Helmet positioning index (HPI) isthe vertical distance from the brow ofthe helmet to the reference plane, whenplaced on a reference headform. Thevertical distance shall be specified bythe manufacturer for each size ofheadform the helmet fits.

(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 to 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.

(i) Preload ballast is a ‘‘bean bag’’filled with lead shot placed on thehelmet 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 shallinclude surface markings correspondingto the basic, coronal, midsagittal, andreference planes (see Figures 1 and 2 tothis part).

(l) Reference plane is a plane markedon the ISO headforms at a specifieddistance above and parallel to the basicplane (see Figure 3 to 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 a 146 mm(5.75 in.) diameter aluminum sphere,with a mass of 4005 ± 5 g (8.83 ± 1.10lb), that is specifically machined formounting onto the ball-arm connector ofthe drop-test assembly. The impactor isused to check the electronic equipment(see § 1203.17).

(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 K–1A magnesium alloyor functionally equivalent metal. Thetest headforms shall include surfacemarkings corresponding to the basic,coronal, midsagittal, and referenceplanes (see Figure 2 to this part).

(q) Test region is the area of thehelmet, on and above a specified testline, that is subject to impact testing.

(r) Visor (peak) is optional helmetequipment for protection against sun orglare, and is sometimes used as a rockor dirt deflector.

§ 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. Rigid

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projections on the inner surface shallnot exceed 2 mm (0.08 in.) and shall notmake contact with the test headformafter testing in accordance with§ 1203.17.

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

marked so that the followinginformation is legible and easily visibleto the user and is likely to remain on thehelmet and legible throughout theintended design life of the helmet:

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

helmet can protect against all possibleimpacts.

(3) A warning 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 forcompetent inspection, or be destroyedand replaced.

(5) A warning to the user that thehelmet can be damaged by contact withcommon substances (for example,certain solvents, cleaners, etc.), and thatthis damage may not be visible to theuser. This label shall also state anyrecommended cleaning agents andprocedures, list any known commonsubstances that damage the helmet, andwarn against contacting the helmet withthese substances.

(6) The statement ‘‘Not For MotorVehicle Use’’.

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

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

the condition in which they are offeredfor sale. They must pass all tests, bothwith and without any attachments thatmay be offered by the helmet’smanufacturer, and with all possiblecombinations of such attachments.

(b) Number of samples. Five samplesof each size for each model andcombination of attachments offered forsale are required to test conformance tothis standard. If a helmet fits more thanone size of test headform, twoadditional samples are needed for eachadditional headform size for the testingdescribed in § 1203.10—Selecting thetest headform.

§ 1203.8 Conditioning environments.

Helmets shall be conditioned to oneof 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 inches of Hg). All testhelmets shall be stabilized within thisambient range for at least 4 hours priorto further conditioning and testing.Storage or shipment within this ambientrange satisfies this requirement.

(a) Ambient condition. The ambientcondition of the test laboratory shall bewithin 17 °C to 27 °C (63 °F to 81 °F),and 20 to 80 percent relative humidity.The ambient test helmet does not needfurther conditioning.

(b) Low temperature. The helmet shallbe kept at a temperature of ¥16 °C to¥13 °C (3 °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 of 17°C to 27 °C (63 °F to 81 °F) to a crowndepth of 305 mm±25 mm (12 in.±1 in.)for 4 to 24 hours prior to testing.

§ 1203.9 Test headforms.

The headforms used for testing shallbe sizes A, E, J, M, and O, as definedby DRAFT ISO/DIS 6220–1983.Headforms used for impact testing shallbe constructed of K–1A magnesiumalloy or other functionally equivalentmetal and must have no resonantfrequencies below 3000 hz.

§ 1203.10 Selecting the test headform.

A helmet shall be tested on theappropriate size(s) of headform(s) onwhich it fits. Fit means that it is notphysically difficult to put the helmet onthe headform, and that the helmet’scomfort or fit padding is partiallycompressed. A complete set of fivehelmets of each size and model shall betested on the smallest size test headformon which they fit. Two additionalhelmets shall be tested on each of thelarger headforms the helmets fit. Testingon the larger headform(s) will include atleast one peripheral vision test, dynamicretention test, positional stability test,and impact attenuation test (completeset of four impacts) using theconditioning environment thatproduced the highest g value in theimpact attenuation tests on the smallestheadform the helmet fit.

§ 1203.11 Marking the test line.Prior to testing, the test line shall be

determined for each helmet in thefollowing manner.

(a) Position the helmet on theappropriate headform as specified bythe manufacturer’s head 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 a test line on the outersurface of the helmet coinciding withthe intersection of the surface of thehelmet with the impact line planesdefined from the reference headform asshown in:

(1) Figure 4 to this part for helmetsintended for adults and for children 5years of age and older.

(2) Figure 5 for helmets intended forchildren under 5 years of age.

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

§ 1203.12 Test requirements.(a) Peripheral vision. The helmet shall

allow unobstructed vision through aminimum of 105° to the left and rightsides of the midsagittal plane whenmeasured in accordance with § 1203.14of this standard.

(b) Positional stability. The helmetshall not release from the test headformwhen tested in accordance with§ 1203.15 of this standard.

(c) Dynamic strength of retentionsystem. The retention system shallremain intact without elongating morethan 30 mm (1.2 in.) when tested inaccordance with § 1203.16 of thisstandard.

(d) Impact attenuation criteria. (1) Forbicycle helmets intended for adults andchildren 5 years and older. The peakacceleration of any impact shall notexceed 300 g when the helmet is testedin accordance with § 1203.17 of thisstandard.

(2) For bicycle helmets intended forchildren under 5 years. The peakacceleration of any impact shall notexceed 250 g when the helmet is testedin accordance with § 1203.17 of thisstandard.

§ 1203.13 Test schedule.(a) One of the set of five helmets shall

be tested for peripheral vision inaccordance with § 1203.14 of thisstandard.

(b) Helmet samples 1 through 4 shallbe conditioned in the ambient, hightemperature, low temperature, andwater immersion environments,respectively. Helmet 5 shall beconditioned in the ambient condition.

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

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from the conditioning environment. Thehelmet shall be returned to theconditioning environment within 3minutes after it was removed for aminimum of 2 minutes before testing isresumed. If the helmet is out of theconditioning environment for longerthan 3 minutes, it shall be reconditionedfor 5 minutes for each minute it is outof the conditioning environment beyond

the allotted 3 minutes before testing isresumed.

(d) Helmets shall be tested fordynamic strength of the retentionsystem prior to being tested for impactattenuation. Helmets 1 through 4(conditioned in ambient, hightemperature, low temperature, andwater immersion environments) shall betested in accordance with the dynamicretention system strength test at

§ 1203.16. Helmets 1 through 4 shallthen be tested in accordance with theimpact attenuation tests on the flat,hemispherical, and curbstone anvils inaccordance with the procedure at§ 1203.17. Helmet 5 (conditioned in anambient environment) shall be tested inaccordance with the positional stabilitytests at § 1203.15. Table 1203.13summarizes the test schedule.

TABLE 1203.13.—TEST SCHEDULE

§ 1203.14Peripheral

vision

§ 1203.15Positionalstability

§ 1203.16Retention

systemstrength

§ 1203.17Impact

tests—4 im-pacts per

helmet

Helmet 1—Ambient .............................................................................................................. X X 1 Flat X1Hemi. X1 Curb. X1 TBD * X

Helmet 2—High Temperature .............................................................................................. X 1 Flat X1 Hemi. X1 Curb. X1 TBD * X

Helmet 3—Low Temperature ............................................................................................... X 1 Flat X1 Hemi. X1 Curb. X1 TBD * X

Helmet 4—Water Immersion ................................................................................................ X 1 Flat X1 Hemi. X1 Curb. X1 TBD * X

Helmet 5—Ambient .............................................................................................................. X X

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

§ 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 to 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 on each side of themidsagittal plane from point K.

§ 1203.15 Positional stability test (roll-offresistance).

(a) Test equipment. (1) Headforms.The geometry of the test headforms shallcomply with the dimensions of the fullchin ISO reference headforms sizes A, E,J, M, and O.

(2) Test fixture. The headform shall besecured in a test fixture with its verticalaxis pointing downward and 45 degreesto the direction of gravity (see Figure 7to this part). The test fixture shall

permit rotation of the headform aboutits vertical axis and include means tolock the headform in the face up andface down positions.

(3) Dynamic impact apparatus. Adynamic impact apparatus shall be usedto apply a shock load to a helmetsecured to a test headform. The dynamicimpact apparatus shall allow a 4-kg (8.8-lb) drop weight to slide in a guided freefall to impact a rigid stop anvil (seeFigure 7). The entire mass of thedynamic impact assembly, including thedrop 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 theheadform so that its face is down, andlock it in that orientation.

(2) Place the helmet on theappropriate size full chin headform inaccordance with the HPI and fasten theretention system in accordance with the

manufacturer’s instructions. Adjust thestraps to remove any slack.

(3) Suspend the dynamic impactsystem from the helmet by positioningthe flexible strap over the helmet alongthe midsagittal plane and attaching thehook over the edge of the helmet asshown in Figure 7.

(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 face pointing upwards, so thatthe helmet is pulled from front to rear.

§ 1203.16 Dynamic strength of retentionsystem test.

(a) Test equipment. (1) ISO headformswithout the lower chin portion shall beused.

(2) The retention system strength testequipment 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). Two cylindrical rollers thatspin freely, with a diameter of 12.5±0.5mm (0.49 in.±0.02 in.) that have acenter-to-center distance of 76.0±1 mm(3.0±0.04 in.), shall make up a stirrupthat represents the bone structure of the

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4 The intent of this requirement is that the fourthimpact will be on the anvil likely to result in thehighest g-value. In the absence of an indication whyanother anvil would be more stringent, this fourthimpact should be made with the anvil thatproduced the highest g-value in the previous threeimpacts.

lower jaw. The entire dynamic testapparatus hangs freely on the retentionsystem. The entire mass of the supportassembly, including the 4-kg (8.8-lb)drop weight, shall be 11 kg±0.5 kg (24.2lb±1.1 lb).

(b) Test procedure. (1) Place thehelmet on the appropriate size headformon the test device according to the HPI.Fasten the strap of the retention systemunder the stirrup.

(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, aretwo methods of measuring theelongation.

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

(1) Measurement of impact attenuation.Impact attenuation is determined bymeasuring the acceleration of the testheadform during impact. Acceleration ismeasured with a uniaxial accelerometerthat is capable of withstanding a shockof at least 1000 g. The helmet is securedonto the headform and dropped in aguided free fall, using a monorail testapparatus (see Figure 9), onto an anvilfixed to a rigid base. The base shallconsist of a solid mass of at least 135 kg(298 lb), the upper surface of whichshall consist of a steel plate at least 12mm (0.47 in.) thick and having a surfacearea of at least 0.10 m2 (1.08 ft2).

(2) Accelerometer. A uniaxialaccelerometer is mounted at the centerof gravity of the test headform, with thesensitive axis aligned within 5 degreesof vertical when the test headform is inthe impact position. The accelerationdata channel and filtering shall complywith SAE Recommended Practice J211OCT88, Instrumentation for ImpactTests, Requirements for Channel Class1000.

(3) Headform and drop assembly—centers of gravity. The center of gravityof the test headform is located at thecenter of the mounting ball on thesupport assembly and lies within aninverted cone with its axis vertical, andforming a 10 degree included angle withthe vertex at the point of impact. Thelocation of the center of gravity of thedrop assembly (combined test headformand support assembly) must meetFMVSS 218 S7.1.8. The center of gravityof the drop assembly lies within therectangular volume bounded by x =

¥6.4 mm (¥0.25 in.), x = 21.6 mm (0.85in), y = 6.4 mm (0.25 in.), and y = ¥6.4mm (¥0.25 in), with the origin locatedat the center of gravity of the testheadform. The rectangular volume hasno boundary along the z-axis. The x-y-z axes are mutually perpendicular andhave positive or negative designationsin accordance with the right-hand rule.The origin of the coordinate axes islocated at the center of the mountingball on the support assembly. The x-y-z axes of the test headform assembly onmonorail impact-test equipment areoriented as follows: From the origin, thex-axis is horizontal with its positivedirection going toward and passingthrough the vertical centerline of themonorail. The positive z-axis isdownward. The y-axis also ishorizontal, and its direction is decidedby the z- and x-axes, using the right-hand rule. See Figure 10 for an overheadview of the x-y boundary of the locationof the center of gravity.

(4) Drop assembly. The center ofgravity of the headform shall be at thecenter of the mounting ball.

(i) Mass of the drop assembly fortesting helmets for adults and children5 years of age and older. The combinedmass of the instrumented test headformand support assembly (excluding thetest helmet) for the impact test shall be5.0 ±0.1 kg (11.00 ±0.22 lb).

(ii) Mass of the drop assembly fortesting helmets for children under 5years. The combined mass of theinstrumented test headform (ISO A orISO E) and support assembly (excludingthe test helmet) for the impact test shallbe 3.9 ±0.1 kg (8.60 ±0.22 lb).

(5) Impact anvils. Impact tests shall beperformed against the three differentanvils described below. All of the anvilsshall be constructed of steel and shall besolid (i.e., without internal cavities).

(i) Flat Anvil. The flat anvil shall havea flat surface area with an impact facehaving a minimum diameter of 125 mm(4.92 in.) and shall be at least 24 mm(0.94 in.) thick (see Figure 11).

(ii) Hemispherical anvil. Thehemispherical anvil shall have animpact surface with a radius of 48 ±1mm (1.89 ±0.04 in.). The profile of theimpact surface shall be one half thesurface of a sphere (see Figure 12).

(iii) Curbstone anvil. The curbstoneanvil shall have two flat faces making anangle of 105 degrees and meeting alonga striking edge with a radius of 15 mm±0.5 mm (0.59 ±0.02 in.). The height ofthe 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).

(b) Test Procedure. (1) Instrumentsystem check. The impact-attenuation

test instrumentation shall be checkedbefore and after each series of tests (atleast at the beginning and end of eachtest day) by dropping an impactor witha spherical impact surface onto anelastomeric test medium (MEP). Theimpactor shall be dropped onto the MEPat a specified impact velocity (±2% of acentral value) that is representative ofhelmet testing drop heights. Beforeconducting a series of drops, the centervertical axis of the accelerometer (see§ 1203.17(a)(2)) shall be aligned with thegeometric center of the MEP pad. Siximpacts, at intervals of 75 ±15 seconds,shall be performed at the beginning andend of the day. The first three impactsat the beginning and end of the dayshall be considered warm-up drops andshall be discarded from the series. Thetest parameters selected at eachlaboratory shall produce impactaccelerations shown to be repeatablewithin ±2% of a central value.

(2) Impact sites. Each of helmets 1through 4 (one helmet for eachconditioning environment) shall impactat four different sites, one impact on theflat anvil, one impact on thehemispherical anvil, one impact on thecurbstone anvil, and one impact on ananvil chosen at the discretion of the testpersonnel.4 The center of any impactmay be on or anywhere above the testline, provided it is at least 120 mm (4.72in), measured on the surface of thehelmet, from any prior impact center.Rivets and other mechanical fasteners,vents, and any other helmet featurewithin the test region are valid test sites.

(3) Impact velocity. The helmet shallbe dropped onto the flat anvil from atheoretical drop height of 2 meters (6.56ft) to achieve an impact velocity of 6.2m/s ±3% (20.34 ft/s ±3%). The helmetshall be dropped onto the hemisphericaland curbstone anvils from a theoreticaldrop height of 1.2 meters (3.94 ft) toachieve an impact velocity of 4.8 m/s±3% (15.75 ft/s ±3%). 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.

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(5) Data. Record the maximumacceleration in g’s during impact.

§ 1203.18 Reflectivity. [Reserved]

Subpart B—Certification

§ 1203.30 Purpose and scope.(a) Purpose. Section 14(a) of the

Consumer Product Safety Act (CPSA),15 U.S.C. 2063(a), 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) further requiresthat the certificate be based either on atest of each product or on a ‘‘reasonabletesting program.’’ The purpose of thissubpart 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) Scope. The provisions of thissubpart apply to all bicycle helmets thatare subject to the requirements of theSafety Standard for Bicycle Helmets.

§ 1203.31 Effective date.Any bicycle helmet manufactured

more than 1 year after publication of afinal rule must meet the standard andmust be certified as complying with thestandard in accordance with thisSubpart 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.

(b) Manufacturer means the entity thateither 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 which 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 and

which 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 definedin § 1203.32(a), shall conduct areasonable testing program todemonstrate that their bicycle helmetscomply with the requirements of thestandard.

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

(1) Manufacturers and importers maydefine their own reasonable testingprograms. Reasonable testing programsmay, at the option of manufacturers andimporters, be conducted by anindependent third party qualified toperform such testing programs.However, manufacturers, as defined in§ 1203.32(a), are responsible for insuringcompliance with all requirements of thisstandard.

(2) To conduct a reasonable testingprogram, the bicycle helmets shall bedivided into production lots. Samplebicycle helmets from each productionlot shall be tested in accordance withthe reasonable testing program.Whenever there is a change in parts,suppliers of parts, or productionmethods that could affect the ability ofthe bicycle 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 all noncomplyingbicycle helmets in the lot have beenidentified and destroyed or altered byrepair, redesign, or use of a differentmaterial or components to the extentnecessary to make them conform to thestandard.

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

§ 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 the effective date ofthe standard in the form of a legible andreadily visible label which canreasonably be expected to remain on thebicycle helmet and legible for theintended design life of the helmet. Suchlabeling shall be deemed to be acertificate of compliance, as that term isused in § 14 of the CPSA, 15 U.S.C.2063.

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

(1) The statement ‘‘Complies withCPSC Safety Standard for BicycleHelmets for Adults and Children Age 5and Older (16 CFR 1203)’’ or ‘‘Complieswith CPSC Safety Standard for BicycleHelmets for Children Under 5 Years (16CFR 1203)’’, as appropriate (for a helmetthat meets the criteria for both an adulthelmet and a helmet for children underage 5, the label may state ‘‘Complieswith the CPSC Safety Standard forBicycle Helmets for Persons of AllAges’’, or equivalent language);

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

(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) An identification of the productionlot; and

(6) The month and year the productwas manufactured.

(c) Coding. (1) The informationrequired by paragraphs (b) (4) through(6) of this section 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 foreign

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manufacturer, may also be in such acode.

(d) Placement of the label(s). Theinformation required by paragraphs (b)(2) through (3) must be on one label,unless allowed to be in code. The otherrequired information may be on separatelabels. The label(s) required by thissection must be affixed to the bicyclehelmet. If the label(s) are notimmediately visible to the ultimatepurchaser of the bicycle helmet prior topurchase because of packaging or othermarketing practices, a second label isrequired. That label shall state, asappropriate, ‘‘Complies with CPSCSafety Standard for Bicycle Helmets forAdults and Children Age 5 and Older’’,or ‘‘Complies with CPSC SafetyStandard for Bicycle Helmets forChildren Under 5 Years’’. Theadditional label must appear on thecontainer or, if the container is notvisible before purchase, on thepromotional material used with the saleof the bicycle helmet. (For a helmet thatmeets the criteria for both an adulthelmet and a helmet for children underage 5, the label may state ‘‘Complieswith the CPSC Safety Standard forBicycle Helmets for Persons of AllAges’’, or equivalent language.)

(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 by§ 14(a) of the CPSA and this section.

(i) 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:

(A) the importer is a resident of theUnited States or has a resident agent inthe United States,

(B) the records of such tests requiredby § 1203.41 of Subpart C of this part aremaintained in the United States, and

(C) such records are available to theCommission upon request to theimporter.

(ii) Test records may be maintainedoutside of the United States if they willbe provided to the Commission within48 hours of a request for the records.

(2) Responsibility of importer. If theimporter relies on tests by the foreignmanufacturer to support the certificateof compliance, the importer 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.The recordkeeping requirements in

this subpart are effective [1 year afterpublication of the final rule] and applyto bicycle helmets manufactured afterthat 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 § 16(b) of the CPSA, 15U.S.C. 2065(b).

(b) Contents of records. Complete testrecords shall be maintained. Recordsshall contain the following information.

(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;(6) The manufacturer’s name and

address;(7) The model and size of each helmet

tested;(8) Identifying information for each

helmet tested, including the productionlot for each helmet, and theenvironmental condition under whicheach helmet was tested;

(9) 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 location of impact, type ofanvil used, velocity prior to impact, andmaximum acceleration measured 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 this

section 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.

Subpart D—Bicycle HelmetsManufactured From March 16, 1995,Through Date That Is 1 Year After theFinal Rule Is Issued

§ 1203.51 Purpose and basis.The purpose and basis of this rule is

to protect bicyclists from head injuriesby ensuring that bicycle helmets complywith the requirements of appropriateexisting voluntary standards, asprovided in 15 U.S.C. 6004(a).

§ 1203.52 Scope and effective date.(a) Bicycle helmets manufactured

after March 16, 1995, through the datethat is 1 year after issuance of the finalstandard (Subparts A, B, and C) shallcomply with the requirements of one ofthe standards specified in § 1203.53.This requirement shall be considered aconsumer product safety standardissued under the Consumer ProductSafety Act.

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

(c) These interim mandatory safetystandards will not apply to bicyclehelmets manufactured after the effectivedate of the final bicycle helmetstandard.

§ 1203.53 Interim safety standards.(a) Bicycle helmets must comply with

one or more of the following standards,which are incorporated herein byreference:

(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 Standard 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, including

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March 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.

(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 ANSI Z90.4

standard are available from: AmericanNational Standards Institute, 11 W.42nd Street, 13th Floor, New York, NY10036. Copies of the ASTM standardsare available from: ASTM, 1916 RaceStreet, Philadelphia, PA 19103. 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: Snell

Memorial Foundation, Inc., P.O. Box493, 7 Flowerfield, Suite 28, St. James,New York 11780. Copies may beinspected at the Office of the Secretary,Consumer Product Safety Commission,4330 East-West Highway, Bethesda,Maryland 20814, or at the Office of theFederal Register, 800 N. Capitol StreetNW, Room 700, Washington, DC.

Figures to Part 1203

BILLING CODE 6355–01–U

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Dated: November 13, 1995.Sadye E. Dunn,Secretary, Consumer Product SafetyCommission.[FR Doc. 95–28761 Filed 12–5–95; 8:45am]BILLING CODE 6355–01–C