Strangulation Hazards Associated With Crib Toys; Withdrawal of Advance Notice of Proposed Rulemaking

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Ch. II

Strangulation Hazards Associated With Crib Toys; Withdrawal of

Advance Notice of Proposed Rulemaking

AGENCY: Consumer Product Safety Commission.

ACTION: Withdrawal of advance notice of proposed rulemaking.

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SUMMARY: The Consumer Product Safety Commission has decided to

terminate a proceeding for the development of requirements to address

strangulation hazards to children associated with crib toys.1 The

Commission began this proceeding by publication of an advance notice of

proposed rulemaking (ANPR) on October 19, 1990.

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\1\The Commission approved publication of this notice by a 2-1

vote, with Chairman Ann Brown dissenting. A copy of Chairman Brown's

separate statement is available upon request from the Office of the

Secretary, Consumer Product Safety Commission, Washington, DC 20207;

telephone (301) 504-0800.

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On October 26, 1993, the Commission voted to terminate this

proceeding and to withdraw the ANPR published in 1990. The Commission

took this action after considering written comments received in

response to the ANPR and correspondence concerning this proceeding;

information about strangulation deaths and injuries to children from

January, 1973, through February, 1993; annual sales of crib toys and

the number of crib toys currently in use; the potential effectiveness

of labeling and other mandatory requirements to reduce strangulation

deaths and injuries to children associated with crib toys; other

written materials prepared by the Commission staff; an oral briefing

presented by the Commission staff; and other information.

The Commission concluded that evidence is not available at this

time to demonstrate that crib toys present an unreasonable risk of

strangulation death or injury to children. The Commission also

concluded that such evidence would not likely be developed if the

proceeding were continued.

FOR FURTHER INFORMATION CONTACT: Celestine M. Trainor, Directorate for

Epidemiology, Consumer Product Safety Commission, Washington, DC 20207;

telephone: (301) 504-0468.

SUPPLEMENTARY INFORMATION:

A. Background

In 1990, the Commission granted a petition which requested issuance

of a rule to address risks of strangulation deaths and injuries to

children associated with certain crib toys and crib mobiles (1).2

The petition used the term ``crib toy'' to describe a variety of toys

which are intended to be strung across a crib or play pen or attached

to the side of a crib or play pen and which are intended to be

manipulated by infants. ``Crib mobiles'' are decorative articles which

are designed to hang above a crib or play pen, but are not intended to

be touched or manipulated by infants. The petition requested issuance

of a rule to:

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\2\Numbers in parentheses identify reference documents listed in

Bibliography at the end of this notice. Requests for inspection of

any of these documents should be made at the Commission's Public

Reading Room, 4330 East West Highway, Bethesda, Maryland, room 419,

or by calling the Office of the Secretary at (301) 492-0800.

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Require that a crib gym or similar manipulative toy

intended to be strung across the top of a crib must have a rigid

horizontal suspension member attachable at or above the height of the

crib side rails with no vertical protrusions;

Prohibit any crib toy from having any protrusions which

can catch clothing or any other item worn by an infant;

Limit the length of any vertical string on any crib toy to

six inches;

Prohibit on any crib toy any cords or other components

which form a perimeter greater than 14 inches;

Prohibit on any crib toy any pull ring attached to a cord;

Ban any crib mobile that can be located within reach of an

infant who is not capable of pushing up on his or her hands and knees

inside a crib;

Require labeling and instructions for various crib toys

and crib mobiles to warn of strangulation hazards associated with those

products.

On October 19, 1990, the Commission published an advance notice of

proposed rulemaking (ANPR) in the Federal Register (55 FR 42402) under

the Federal Hazardous Substances Act (FHSA) (15 U.S.C. 1261 et seq.) to

begin a proceeding to develop the rule requested by the petition (2).

B. Statutory Authority

Section 2(f)1(D) of the FHSA (15 U.S.C. 1261(f)1(D)) defines the

term ``hazardous substance'' to include ``[a]ny toy or other article

intended for use by children'' which the Commission determines by

regulation to present a ``mechanical hazard.'' Section 2(s) of the FHSA

(15 U.S.C. 1261(s)) provides that a toy or children's article may be

determined to present a

mechanical hazard if, in normal use or * * * reasonably foreseeable

* * * abuse, its design or manufacture presents an unreasonable risk

of personal injury * * * from * * * points or other protrusions, * *

* openings, or closures, * * * or * * * because of any other aspect

of the article's design or manufacture.

The Commission may make a determination that a toy or children's

article presents a mechanical hazard by issuance of a regulation in

accordance with provisions of sections 3(e) through (i) of the FHSA (15

U.S.C. 1262(e)-(i)). A toy or children's article which is the subject

of a rule issued in accordance with provisions of sections 3(e) through

(i) and which fails to comply with all requirements of such a rule is a

``banned hazardous substance'' as that term is defined by section

2(q)(1)(A) of the FHSA (15 U.S.C. 1261(q)(1)(A)). The introduction into

interstate commerce of a banned hazardous substance is prohibited by

section 4 of the FHSA (15 U.S.C. 1263).

Section 3(f) of the FHSA (15 U.S.C. 1262(f)) requires publication

of an ANPR to begin a proceeding for issuance of a rule in accordance

with sections 3(e) through (i) to make a determination that a toy or

children's article presents a ``mechanical hazard.'' Section 3(f) also

sets forth requirements for the content of the ANPR.

In accordance with section 3(f) of the FHSA, the ANPR for crib toys

identified the products and the risk of injury which are the subject of

the rulemaking proceeding, and set forth the regulatory options under

consideration by the Commission. The ANPR stated that the Commission

was considering issuance of any or all of the requirements requested by

the petition. The ANPR also summarized provisions applicable to crib

toys in a voluntary standard published by ASTM (formerly the American

Society for Testing and Materials), designated F963-86, Standard

Consumer Safety Specification for Toy Safety. In addition, the ANPR

stated that the Commission was also considering the possibility that

this voluntary standard could be revised to address additional hazards

associated with crib toys, or that a new voluntary standard could be

developed to address those hazards (2).

As required by section 3(f) of the FHSA, the ANPR solicited

comments from interested persons about the products and risk of injury

under consideration; invited interested persons to submit an existing

standard as the proposed regulation; and invited interested persons to

submit a statement of intention to develop or modify a voluntary

standard to address risks of strangulation death and injury associated

with crib toys. (2) In response to the ANPR, the Commission received

comments from 17 organizations and individuals (3-19). The Commission

also received a joint-communication from six organizations concerning

the proceeding for crib toys after the close of the comment period for

the ANPR (20).

On September 21, 1993, the Commission staff transmitted to the

Commissioners a briefing package of information concerning the

development of requirements to address strangulation hazards associated

with crib toys (21). On October 22, 1993, the staff presented an oral

briefing to the Commission concerning this proceeding.

C. Action by the Commission

On October 26, 1993, the Commission voted to terminate the

rulemaking proceeding applicable to crib toys and to withdraw the ANPR

published on October 19, 1990.

To make a determination that a product presents an ``unreasonable

risk of injury'' under the FHSA, the Commission considers:

The nature and severity of the risk of injury associated

with the product;

The potential of mandatory requirements for the product to

reduce the frequency and severity of the injury; and

The effect of mandatory requirements on the cost, utility,

or availability of the product.

Additionally, section 3(i) of the FHSA (15 U.S.C. 1262(i)) provides

that in order to issue a final rule expressing the Commission's

determination that a toy presents a ``mechanical hazard,'' the

Commission must prepare a regulatory analysis which includes a

description of potential benefits and potential costs of the rule and

identifies those parties likely to receive the benefits and to bear the

costs. Section 3(i) provides further that the Commission may not issue

a final rule unless it makes a finding that ``the benefits expected

from the regulation bear a reasonable relationship to its costs.''

Applying the factors involved in the determination of an

unreasonable risk of injury to the information developed during this

proceeding, the Commission finds the following:

The Nature and Severity of the Risk of Injury

The nature of the risk of injury associated with crib toys is

strangulation on the product. Strangulation injuries may result in

death or permanent brain damage. For this reason, strangulation

injuries have the potential to be of the utmost severity.

However, the likelihood of a strangulation incident involving a

crib toy is relatively small. During the period from January, 1973,

through February, 1993, 28 children died in strangulation accidents

associated with crib toys, an average of three deaths every two years

(22). During the same period, one child sustained permanent brain

damage from a strangulation accident associated with a crib toy (22).

At the same time, however, an estimated 10 to 25 million crib toys were

sold each year, and an estimated 50 million crib toys were in use on

any given date (23).

The Potential of Mandatory Requirements To Reduce the Frequency and

Severity of the Risk of Injury

The information considered by the Commission indicates that the

potential of mandatory requirements to reduce risks of strangulation

death and injury associated with crib toys is limited.

A 1987 analysis of strangulation injuries associated with crib toys

identified three hazard patterns involved in 32 fatalities. In seven of

these fatalities, an article worn by the child, such as a bib or a

necklace, caught on a protrusion of a crib toy (24). After publication

of the ANPR, the Commission undertook additional work to identify

characteristics of hazardous protrusions. However, the Commission has

not been able to develop an objective test to distinguish those

protrusions which present a strangulation hazard from those which do

not (21, 25).

Another hazard pattern identified in the 1987 analysis was that of

postural strangulation. In six of the fatalities described in that

analysis, the child's head and neck were suspended over a horizontal

cord. All but one of these cases involved crib gyms. The 1987 analysis

recommended that the horizontal member of a crib gym should consist of

a rigid structure rather than a cord, and that the design of a crib gym

should not allow installation of the product below the height of the

top rails of the crib sides (24). These recommendations were intended

to eliminate the risk of postural strangulation associated with a crib

gym left in a crib occupied by a child who is able to push up on his or

her hands and knees (typically, a child older than five months of age).

However, after consideration of more recently developed

information, the Commission is concerned that a design requirement for

a rigid horizontal member on a crib gym could create other risks of

injury to a child who is able to push up on his or her hands and knees.

If one end of a crib gym with a rigid horizontal member became detached

from the side of the crib and rested on the crib mattress, the crib gym

might provide a means by which such a child could climb over the side

rail of the crib (21). Additionally, if a crib gym with a rigid

horizontal member were installed near the end panel of a crib, another

risk of strangulation injury might result if that placement created an

opening which would be large enough to allow a child's head to enter,

but which would be too small for the head to exit if turned to another

orientation (21).

The third hazard pattern discussed in the 1987 analysis of

strangulation incidents associated with crib toys resulted when a

child's neck became entangled in one or more strings or cords of a crib

toy. Four of the fatalities discussed in that analysis resulted when a

child's neck became entangled in two or more cords attached to a

stuffed toy animal (24). A comment on the ANPR from an association of

toy manufacturers observed that stuffed animal toys with attached

suspension cords are prohibited by the voluntary toy safety standard,

and that such toys have not been manufactured for several years (8).

Two other fatalities discussed in the 1987 analysis resulted when a

child's neck became entangled in a single vertical cord which extended

from a crib toy (24). To address that risk of strangulation, the 1987

analysis recommended that the length of any vertical string attached to

a crib toy should not exceed six inches. However, the comment from the

association of toy manufacturers states that no report of any fatality

resulting from entanglement in a single vertical cord extending from a

crib toy has been received since 1986 when the voluntary toy safety

standard was revised to restrict the length of such cords to less than

12 inches. (8)

The 1987 analysis of crib toy strangulation incidents also

recommended that crib mobiles should be labeled to warn that the

article should be kept out of the reach of infants, and should be

removed when the infant attains the age of five months or is able to

push up on his or her hands and knees. That analysis further

recommended instructions accompanying crib toys should include warnings

to place the crib mattress in one of the lower positions and to raise

the crib drop side when attaching a crib toy. (24) However, the

Commission has received newer information indicating that labeling

alone cannot be expected to reduce strangulation hazards associated

with crib toys (25).

The Effect of Mandatory Requirements on the Cost, Utility, and

Availability of the Product

The Commission was unable to obtain information about the costs

which might result to manufacturers or consumers from imposing any of

the requirements for crib toys discussed in the ANPR. The Commission

did not attempt to make cost estimates because of uncertainty about the

numbers and specific kinds of crib toys which might be affected by each

of the requirements discussed in the ANPR.

D. Voluntary Standard

The Commission also considered alternatives to development of

mandatory requirements for crib toys. These alternatives included

existing provisions of a voluntary standard for toy safety intended to

address risks of strangulation injury associated with crib toys, and

revisions of that voluntary standard which were under consideration at

the time the Commission decided to terminate this proceeding.

The proposed revisions included the addition of design guidelines

to the voluntary standard to minimize strangulation hazards from

protrusions on crib toys. The guidelines are intended to be used by

manufacturers in the development of crib toys (27, 28).

As noted above, the Commission staff was not able to devise

objective criteria to identify protrusions on crib toys which present a

strangulation hazard. In the absence of objective criteria to identify

hazardous protrusions, the Commission concludes that addition of the

proposed design guidelines to the voluntary standard would be

worthwhile (27).

The revisions of the voluntary standard under consideration also

included:

Language to limit to 14 inches the perimeter formed by

strings or cords which can tangle to form a loop;

Improved warning labels concerning strangulation hazards

associated with crib gyms and similar toys intended to be strung across

the top of a crib or playpen;

Addition of labeling requirements for crib mobiles to

advise parents of precautions needed to minimize strangulation hazards

associated with those products;

Addition of language to the instructions to accompany crib gyms and

similar toys to advise parents of precautions to be taken to minimize

strangulation hazards associated with those products. (27)

After considering information about the voluntary standard and

proposed revisions of that standard, the Commission concludes that the

proposed changes would adequately address the hazards identified in the

ANPR.

Section 3(g)(2) of the FHSA requires the Commission to terminate a

proceeding for the development of a rule to address an unreasonable

risk of injury associated with a toy or children's article if the

Commission determines that a voluntary standard developed or modified

after publication of the ANPR adequately addresses the risk of injury

under consideration and that substantial compliance with such a

voluntary standard is likely to be achieved.

However, provisions of section 3(g)(2) apply only to a voluntary

standard which has been ``finally approved'' by the organization which

developed the standard. The proposed revisions of the ASTM voluntary

standard for toys discussed above have not yet been finally approved by

ASTM. For that reason, the Commission is not required by section

3(g)(2) of the FHSA to terminate this proceeding.

E. Conclusions by the Commission

From its consideration of all available information about risks of

strangulation injuries to children associated with crib toys and

mandatory requirements to address those risks, the Commission concludes

that:

(1) To date, information has not been developed to establish that

crib toys present an unreasonable risk of strangulation injury to

children;

(2) Consequently, information has not been developed to establish

that issuance of a mandatory rule for crib toys to address that risk of

injury is reasonably necessary; and

(3) If this proceeding were continued, such information would not

likely be developed.

The Commission also concludes that information is not now available

or likely to be developed to support a finding that the expected

benefits from a mandatory rule to address strangulation hazards

associated with crib toys would bear a reasonable relationship to the

costs imposed by such a rule. Such a finding is required by section

3(i) of the FHSA to issue a rule for crib toys.

Accordingly, the Commission hereby withdraws the ANPR published in

the Federal Register of October 19, 1993 (55 FR 42402) to initiate a

proceeding for development of requirements to address risks of

strangulation deaths and injuries associated with crib toys.

Dated: July 7, 1994.

Sadye E. Dunn,

Secretary, Consumer Product Safety Commission.

Bibliography

1. Petition from Consumer Federation of America and the New York

State Attorney General's Office requesting issuance of a rule to ban

certain crib toys, 74 pages, November 17, 1988.

2. Federal Register notice, ``Strangulation Hazards Associated

With Crib Toys; Advance Notice of Proposed Rulemaking,'' published

by the Consumer Product Safety Commission, 4 pages, October 19, 1990

(55 F.R. 42402).

3. Comment from Daniel Chaucer, P.E., 3 pages, October 28, 1990.

4. Comment from Sligo International, 1 page, November 6, 1990.

5. Comment from The First Years, 2 pages, December 5, 1990.

6. Comment from U.S. Public Interest Research Group, 3 pages,

December 12, 1990.

7. Comment from Fisher-Price, 8 pages, December 13, 1990.

8. Comment from Toy Manufacturers of America, Inc., 17 Pages,

October 19, 1990.

9. Comment from Oregon State Public Interest Research Group, 4

pages, December 14, 1990.

10. Comment from Dolly, Inc., 2 pages, December 17, 1990.

11. Comment from Massachusetts Public Interest Research Group, 2

pages, December 17, 1990.

12. Comment from the Coalition for Consumer Health & Safety, 2

pages, December 18, 1990.

13. Comment from Consumer Federation of America, 9 pages,

December 18, 1990.

14. Comment from Marcella V. Ridenour, 1 page, December 1, 1990.

15. Comment from Jolly Jumper, Inc., 2 pages, December 17, 1990.

16. Comment from J. M. Miller Engineering, Inc., 6 pages,

November 17, 1990.

17. Comment from Allegheny County Health Department, 2 pages,

December 18, 1990.

18. Comment from American Society of Safety Engineers, 2 pages,

December 19, 1990.

19. Comment from Dorothy A. Drago, 2 pages, January 8, 1991.

20. Letter from Consumer Federation of America, Consumes Union,

The Danny Foundation, National Safe Kids Campaign, Public Citizen

Congress Watch, and U.S. Public Interest Research Group to

Jacqueline Jones-Smith, Chairman, Consumer Product Safety

Commission, 4 pages, October 25, 1993.

21. Memorandum from Celestine Trainor, Project Manager, to the

Commission, subject ``Options on Crib Toys,'' 15 Pages, September

21, 1993.

22. Memorandum from Suzanne P. Cassidy, EPHA, and Debbie

Tinsworth, EPHA, to Celestine Trainor, EPHF, subject ``Crib Toys--

Data Update and Response to ANPR Comments on Strangulation

Hazards,'' 2 pages, March 27, 1993.

23. Memorandum from Anthony C. Homan, ECPA, to Celestine

Trainor, Project Manager, subject ``Crib Toys--Regulatory

Discussion,'' 2 pages, April 19, 1993.

24. Human Factors Evaluation of Provisions Which Address Crib

Toy Strangulations in the Toy Safety Voluntary Standard,'' by

Shelley Waters Deppa, 20 pages, July, 1987.

25. ``Characteristics of Catch Point Incidents Contributing to

Strangulation on Crib Toys and Other Children's Products,'' by

Shelley Waters Deppa, 30 pages, October, 1992.

26. Letter from John Preston, ESME, to Charles A. Brooks,

Fisher-Price, 2 pages, February 17, 1993.

27. Memorandum from Celestine Trainor, EPHF, to Jacqueline

Elder, Director, EPHF, subject ``Comparison of Current and Proposed

Voluntary Standard Requirements for Crib Toys and Staff Response,''

6 pages, July 7, 1993.

28. Design Criteria, 1 page.

29. Press Release of Chairman Jacqueline Jones-Smith on

Strangulation Hazards Associated with Crib Toys, 1 page, October 16,

1993.

30. Statement of Commissioner Carol G. Dawson on The Termination

of Rulemaking on Crib Toys, 2 pages, October 26, 1993.

31. Statement of Mary Sheila Gall on Termination of the

Rulemaking Proceedings Related to Crib Toys, 1 page, October 26,

1993.

[FR Doc. 94-16876 Filed 7-12-94; 8:45 am]

BILLING CODE 6355-01-P