Proposed Rule To Ban Small Balls Intended for Children Younger Than Three Years of Age and To Require Labeling of Certain Toys and Games

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1500

Proposed Rule To Ban Small Balls Intended for Children Younger

Than Three Years of Age and To Require Labeling of Certain Toys and

Games

AGENCY: Consumer Product Safety Commission.

ACTION: Proposed rule.

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SUMMARY: The Child Safety Protection Act of 1994 (CSPA) amended the

Federal Hazardous Substances Act (FHSA) by adding a new section 24,

which imposes labeling requirements on balls, balloons, marbles, and

certain toys and games intended for use by children three years of age

and older. The amendment also bans certain balls intended for use by

children younger than three years of age and requires that choking

incidents involving small balls, balloons, marbles, and toys or games

containing such articles or other small parts must be reported to the

Consumer Product Safety Commission (the Commission). The ban of small

balls and the labeling provisions are enforced under the authority of

the FHSA; the reporting requirements are enforced under the authority

of the Consumer Product Safety Act.

Although the requirements imposed by the amendments are generally

self-executing, the Commission is proposing these regulations to

incorporate the requirements of the CSPA into the Code of Federal

Regulations (CFR) and to interpret or clarify certain provisions of

that legislation.

DATES: Written comments in response to this proposed rule must be

received by the Commission no later than September 14, 1994.

ADDRESSES: Comments, preferable in five (5) copies, should be mailed to

the Office of the Secretary, Consumer Product Safety Commission,

Washington, DC 20207-0001, telephone (301) 504-0800, or delivered to

Room 502, East-West Towers Building, 4330 East West Highway, Bethesda,

MD 20814.

FOR FURTHER INFORMATION CONTACT: Michael J. Gidding, Attorney, Office

of Compliance and Enforcement, Consumer Product Safety Commission,

Washington, DC 20207-0001; telephone (301) 504-0626, ext. 1344.

SUPPLEMENTARY INFORMATION:

A. Background

In 1979, the Commission issued regulations to ban toys and other

articles which are intended for children younger than three years of

age and which present an aspiration, ingestion, or choking hazard

because of small parts. The small parts regulations are codified at 16

CFR 1500.18(a)(9) and Part 1501. Toys and children's articles subject

to the regulations must be placed in a truncated cylinder with a

diameter of 1.25 inches (31.7 mm.) and a depth ranging from 1 to 2.25

inches (25.4 mm to 57.1 mm). If the product or any independent or

detachable component of the product fits entirely within the cylinder,

it is banned. Additionally, a toy or children's article is banned if

any component or piece of such a product becomes detached during ``use

and abuse'' testing. The ``use and abuse'' tests are codified at 16 CFR

1500.51 and 1500.52.

The small parts regulations apply only to toys and articles

intended for use by children younger than three years of age. Some

products, including balloons, are excluded from the scope of these

regulations because they cannot be manufactured to function as intended

and still comply with the requirements of the regulations.

Previously, the Commission received information indicating that an

average of seven children a year choke to death on balloons or parts of

balloons. The agency also received reports of children younger than

three choking on small toys or games, or the parts of such products,

which were intended for children three years of age and older. For

example, small balls and marbles are generally considered to be

intended for such older children, but have been associated with choking

fatalities involving children under three.

In some cases, choking incidents involving children younger than

three years of age occurred after an adult purchased a product labeled

to indicate that the article was suitable for children three years and

older, but gave the article to a child younger than three. In such

cases, it is possible that the purchaser believed that the labeling

statement was not a safety message, but instead referred to the age at

which the child could use or enjoy the product.

In 1990, the Commission published four advance notices of proposed

rulemaking to require precautionary labeling warning of the choking

hazards associated, respectively, with balloons, small balls, marbles,

and toys with small parts intended for children three years of age and

older. In 1992, after consideration of the records prepared by the

Commission staff, the Commission voted to withdraw all four notices.

B. The New Legislation

To provide additional protection for young children from the

hazards of choking, ingestion, or aspiration associated with small

objects, Congress amended the Federal Hazardous Substances Act (FHSA),

15 U.S.C. 1261 et seq., by enacting the Child Safety Protection Act of

1994 (CSPA), Public Law 103-267. The CSPA establishes a new section 24

to the FHSA (15 U.S.C. 1278) that requires precautionary labeling for

certain latex balloons, marbles, small balls, and certain toys and

games that contain such items or other small parts. The labeling is

designed to warn purchasers that such products can choke children

younger than three years of age or, in the case of balloons, younger

than eight years of age. Products subject to section 24 that do not

bear the required cautionary labeling are misbranded hazardous

substances under section 2(p) of the FHSA (15 U.S.C. 1261(p)). The new

statute also bans any ball with a diameter of 1.75 inches or less

intended for children younger than three years of age.

The CSPA directs the Commission to promulgate regulations in

accordance with 5 U.S.C. 553 to implement the ban of small balls and

the labeling requirements. In addition, with respect to toys or games

intended for children between the ages of three and six years, the

section 24(a) of the FHSA authorizes the Commission to set an upper age

no lower than five years, and to define the term ``small part.''

C. Proposed Regulation

To implement section 24 of the FHSA and the other requirements of

the new CSPA, the Commission proposes this regulation for public

comment. The purpose of the proposed regulation is to incorporate the

ban of certain small balls and the labeling requirements imposed by the

CSPA into the Code of Federal Regulations (CFR). Additionally, the

Commission has determined that some provisions of the CSPA require

interpretation or clarification. Accordingly, the proposed regulation

defines terms such as ``ball,'' ``small ball,'' ``small part,'' and

``descriptive material''; establishes criteria for determining the age

of children for which a toy or game is intended; and clarifies the

applicability of the type size, placement and conspicuousness

requirements of the regulation codified at 16 CFR 1500.121 to, inter

alia, the packaging of and descriptive literature that accompanies

products subject to the new labeling requirements. The following is a

brief discussion of the principal provisions of the proposed

regulation.

1. Balls and Small Balls

The CSPA bans any ball with a diameter of 1.75 inches or less that

is intended for use by children younger than three years of age. The

CSPA also adds a new section 24 of the FHSA, which requires that such

balls must be labeled if they are intended for older children. The CSPA

does not, however, define the term ``ball''. The Commission believes

the choking hazard that Congress intended to address is associated with

balls typically used in children's games or play, such as board games,

``jacks,'' paddle ball, or catch, rather than with rounded or spherical

objects (such as the heads of figurines) produced during the molding of

toys. However, the Commission believes that Congress did not intend to

apply the term ``ball'' exclusively to spherical objects. Thus, the

term ``ball'' includes spherical objects (such as balls for jacks and

miniature soccer balls); ellipsoidal objects (such as miniature

footballs); multi-sided objects (sometimes referred to as ``crazy

balls'') that are formed by connecting planar surfaces and are

designated or intended for use as balls; and novelty items (such as

balls with facial characteristics molded on them) that are designated

or intended for use as balls.

The Commission proposes to define the term ``ball'' to include any

spherical, ovoid, or ellipsoidal object that is intended to be thrown,

hit, kicked, rolled, or bounced. The definition includes balls attached

to such a toy or article by a string, elastic cord, or similar

material. The term also includes any multi-sided object formed by

connecting planes into a generally spherical, ovoid, or ellipsoidal

shape that is designated or intended for use as a ball and any novelty

item designated or intended for use as a ball.

Dice and similar items would not be included in the proposed

definition of ``ball'' because they are not generally viewed as being

balls in the traditional sense of the term. The proposed rule excludes

from the definition of the term ``ball'' any ball that is permanently

enclosed in a pinball machines, maze, or similar outer container.

A ``small ball'' is a ball with a diameter of 1.75 inches or less.

The regulation includes a procedure for determining the diameter of a

ball.

2. Small Part

A test procedure for determining whether an article is a small part

is included in the regulation banning toys and other articles intended

for use by children younger than three years of age which present

choking, aspiration, or ingestion hazards because of small parts. (16

CFR 1501.4) That procedure specifies that the article shall be placed,

without compressing it, into a cylinder of specified dimensions. If the

article fits entirely within the cylinder in any orientation, it is

classified as a small part. The regulation also specifies that an

article which does not fit entirely within the cylinder shall be

subjected to the appropriate ``use and abuse'' tests (codified at 16

CFR 1500.51 and 1500.52) to determine whether components or pieces

become detached. Any such component or piece is also evaluated using

the ``small parts'' cylinder.

The tests for small parts described above are designed to reduce

risks of injury to children under three years of age, and are based on

anthrompometric data and human experience. Section 24 of the FHSA is

also designed to address the risk of injury to children younger than

three years of age. The Commission therefore believes that the test

procedures used to evaluate toys or other articles intended for such

children are also appropriate for evaluating toys and games, and

components of such games or toys (such as game pieces or accessories

intended to be detached or removed from a toy or game), which are

intended for use by children between three and six years of age.

Accordingly, the Commission has defined the term ``small part'' by

incorporating by reference in this proposed rule the test procedures of

16 CFR 1501.4(a) and 1501.4(b)(1) used to evaluate toys or other

articles intended for use by children younger than three years of age.

In adopting this approach, the Commission has not included a

general requirement that all such toys, games, or components be

subjected to ``use and abuse'' tests if these articles otherwise do not

meet the definition of a small part. The legislation, as drafted,

applies only to toys or games that ``include'' a small part, indicating

that Congress was primarily concerned with small components of such

games or toys rather than pieces that may break off or become detached

from such articles during foreseeable use or abuse. Although the term

``include'' could be interpreted to encompass pieces resulting from use

and abuse as well, the legislative history of the CSPA is silent on

this issue. At this time, the Commission lacks sufficient information

to establish the need to apply ``use and abuse'' tests to all toys and

games intended for use by children between three and six years of age

and on the costs associated with imposing such testing requirements. In

the absence of such information and in the interest of providing

immediate guidance to manufacturers affected by the new legislation,

the Commission, at this time, has decided not to propose ``use and

abuse'' testing requirements for toys or games intended for children

between the ages of three and six years.

3. Toys and Games Intended for Use by Children Who Are at Least Three

Years Old But Not Older Than Six Years

Section 24 of the FHSA establishes labeling requirements for any

toy or game that includes a small part and is ``intended for use by

children who are at least 3 years old but not older than 6 years.''

However, section 24 does not specify how the age of the intended user

of a game or toy is to be determined. The provisions of 16 CFR 1501.2

set forth the criteria the Commission uses to determine whether a toy

or article is intended for use by children younger than three years of

age. These criteria include: the manufacturer's stated intent (such as

the age stated on a label) if it is a reasonable one; the advertising,

promotion, and marketing of the article; and whether the article is

commonly recognized as being intended for children in this specified

age group. Additionally, the provisions of 16 CFR 1501.5 afford a firm

whose products may be the subject of an enforcement action the

opportunity to present arguments and evidence that the products are not

violative before the Commission initiates such an action.

The Commission believes that similar criteria and enforcement

procedures are appropriate to evaluate whether products are intended

for children between the ages of three and six years. Accordingly, the

Commission has included provisions in the proposed regulation similar

to those codified at 16 CFR 1501.2 and 1501.5.

4. Upper Age Limit

Section 24 of the FHSA permits the Commission to establish an

alternative age to the upper limit of six years specified in the law

for toys or games required to be labeled because they contain small

parts and are intended for use by children at least three years of age.

The alternative limit may not be less than five years of age. For the

following reasons, the Commission does not propose to adopt a limit

different from six years at this time.

From 1990 through 1993, the Commission staff conducted research on

the issue of requiring precautionary labeling on packages of toys and

games intended for children older and three years of age. As part of

this activity, the Commission staff reviewed literature on child

development, the play interests of different age groups of children,

and early childhood education and practice. The Commission also

contracted with outside experts to assist in evaluating the appropriate

upper age limit for such labeling.

The staff research confirms that three and four year old children

have similar motor skills, cognitive and emotional development, and

play interests. However, the skills, levels of development, and play

interests of such children differ significantly from those of children

five years and older. Accordingly, the staff originally recommended to

the Commission that labeling should be required on toys and games

intended for three and four year old children (those from 36 months of

age up to, but not including, 60 months of age). The staff believed

that this age range would provide a reasonable degree of protection to

children younger than three years of age and would reflect a break

between the preschool and school years that could be easily understood

by parents. (Options on Choking Hazards Briefing Package, December 30,

1991, TAB C, Memorandum from Shelley Waters Deppa, EPHF, to Marilyn

Wind, Ph.D., entitled ``Transmittal of Report on Choking Hazard Labels

for Toys,'' August 31, 1991.)

However, section 24 of the FHSA prohibits the Commission from

establishing an alternative age that is less than five years. Although

the data relied on by the staff in its original recommendation supports

labeling for toys and games intended for three and four years olds, it

does not in itself provide a basis for specifying an upper age limit

for product labeling that is less than the six years specified in the

legislation. Thus, at this time, the Commission declines to propose an

upper age limit different from the one specified in section 24 of the

FHSA.

The Commission recognizes that products intended for children of a

specified age are generally recognized as being suitable for all

children in that age group. For example, a toy labeled for use by

children six years old is typically viewed as being appropriate for

children who have just turned six, as well as for those approaching

their seventh birthday. Accordingly, the Commission proposes that the

labeling provisions for toys and games that contain small parts shall

apply to those toys or games intended for children three years of age

and older, but younger than seven years of age. This approach is also

consistent with the Commission's Guidelines for Relating Children's

Ages to Toy Characteristics, which the Commission staff uses to

evaluate toys and other articles intended for use by children.

5. ``Manufacture for Sale'' * * * ``Distribution in Commerce''

The various products enumerated in the CSPA are subject to the

labeling requirements of section 24 of the FHSA if they are

``manufactured for sale, offered for sale, or distributed in commerce

in the United States.'' Items which fail to comply with the

requirements are misbranded hazardous substances under section 2(p) of

the FHSA (15 U.S.C. 1261(p)).

Section 4 of the FHSA (15 U.S.C. 1263) identifies several

transactions involving the manufacture, sale, and distribution of

misbranded hazardous substances as ``prohibited acts''. The term

``distributed in commerce'' in section 24 of the FHSA is arguably

broader than the transactions described as prohibited acts in section 4

of the FHSA. However, the initiation of an enforcement action for

violation of section 24 of the FHSA will still hinge on whether the

Commission has evidence to support the conclusion that a manufacturer

has violated section 4 (a), (b), (c), or (g) of the FHSA. In other

words, it is theoretically possible for a product in violation of the

labeling requirements to be ``distributed in commerce'' as specified in

section 24 of the FHSA without being involved in any transaction

prohibited by the literal text of section 4. To avoid confusion and in

recognition of the substantial overlap between the acts prohibited by

section 4 of the FHSA and the ``manufacture, sale, and distribution''

language of section 24, the Commission has not included reference to

the latter in text of the proposed rule.

6. Descriptive Material

Section 24 of the FHSA requires that descriptive material that

accompanies any product subject to its labeling provisions must also

bear the required labeling. This proposed regulation defines the term

``descriptive material'' as follows. The term encompasses any

instruction for use (whether written or otherwise) of a product subject

to these labeling requirements, any depiction of the product, and any

promotional material, advertisement, or other written literature that

describes any function, use, warnings, user population, design or

material specification, or other characteristic of the product,

including its suitability for use with or relation to other games,

products, or toys. Descriptive material ``accompanies'' a product

subject to the labeling requirements when it is packaged with the

product, or when it is intended to be distributed with the product at

the time of sale or delivery to the purchaser.

7. Prominence and Conspicuousness of Labeling

Section 24 of the FHSA requires generally that any cautionary

statement mandated by the Child Safety Protection Act of 1994 appear on

the principal display panel of the package of a regulated product.

Section 24 requires further that such statements be displayed in the

English language in conspicuous and legible type in contrast by

typography, layout, or color with other printed material on the package

of a product, on descriptive material that accompanies the product,

and, if such a product is sold unpackaged, on any bin, container, or

vending machine from which the product is sold or dispensed. The

required labeling statements ``shall be displayed * * * in a manner

consistent with part 1500 of title 16, Code of Federal Regulations.''

Section 24 also makes some exceptions to these general requirements for

specific products.

The Commission previously codified at 16 CFR 1500.121 an

interpretative rule containing general labeling policies. The

commission views these policies as satisfying the general requirements

of section 2(p)(2) of the FHSA relating to the prominence and

conspicuousness of precautionary labeling statements for hazardous

substances. Because the language of section 24 of the FHSA is

substantially the same as that of section 2(p)(2), the Commission

believes it appropriate to incorporate by reference the interpretations

and policies contained in 16 CFR 1500.121 in the rule proposed below,

with some modifications.

Under 16 CFR 1500.121(b)(2)(ii), all items required to appear on

the principal display panel of a package must be blocked together in a

square or rectangular area with or without a border. The color of that

area is not specified in the regulation. The packages of products

subject to the CSPA, however, generally contain many visual messages in

the form of printed product descriptions and depictions and in see-

through features that permit the actual products to be displayed. As a

result, even if a labeling statement required by the CSPA technically

complies with the existing requirements of 16 CFR 1500.121(b)(2)(ii),

the messages provided by that statement often may be obscured by the

other visual messages on the display panel. To assure that the

precautionary labeling prescribed by the CSPA effectively alerts the

public to potential hazards, the Commission proposes that the color of

the square or rectangular area in which the precautionary labeling

appears be in sharp contrast to the background color of the area of the

package on which it appears, to the color of any printed matter in

proximity to the required labeling statement, and, if the package is a

see-through package, to the color of the article contained in the

package. The color of the required cautionary labeling statements shall

be in sharp contrast to background color of the square or rectangular

area. This approach is consistent with the current principles of the

American National Standards Institute (ANSI) Z535.4-1991 Standard for

Product Safety Signs and Labels. The Commission solicits comment on

this approach and suggestions for other alternatives to assure that the

labeling statements required by the CSPA are conspicuous.

Since 16 CFR 1500.121 contains no provisions applicable to the

triangle symbol required by the legislation, the Commission proposes

the following provisions for such symbols. The triangle shall be an

equilateral triangle to assure that the conspicuousness of the triangle

is not negated by the use of an elongated figure. With respect to the

size of the triangles, the proposed rule says the height of the

triangle shall be at least the height of the letters in the

accompanying signal word ``WARNING''. These provisions are consistent

with the approach taken in ANSI Standard Z552.4-1991 and in the

legislation itself, which depicts triangles larger than the signal

word. The height of the exclamation point inside the triangle shall be

half the height of the triangle, and the exclamation point shall be

centered vertically in the triangle. In all other respects, the

triangles with exclamation points shall conform generally to the

provisions of 16 CFR 1500.121 relating to signal words. However, to

assure that it is conspicuous, the triangle shall be separated from the

signal word by a distance at least equal to the space occupied by the

first two letters of the signal word. The Commission solicits comments

on this approach, as well as recommendations for alternative

approaches.

With respect to the various labeling statements required by section

24 of the FHSA, the word ``WARNING'' shall be regarded as a signal

word, and the statement of the principal hazard associated with the

products subject to the proposed regulation. The remaining statements

required by the legislation shall be regarded as ``other cautionary

material'' as that term is defined in 16 CFR 1500.121(a)(2)(viii).

However, because section 24 requires that all of the labeling

statements mandated by the law must appear on the principal display

panel, the provision of 16 CFR 1500.121(b)(3) allowing ``other

cautionary labeling'' to be placed on a display panel other than the

principal display panel shall not apply, except as provided for by

section 24(c)(3) which establishes alternative rules for small packages

containing multi-lingual warnings. In the latter case, the requirements

of 16 CFR 1500.121 relating to the placement on the principal display

panel and type size of statements or indicators directing attention to

other cautionary labeling that appear on another display panel shall

apply.

The proposed rule requires a space between the signal word and the

remainder of the message. It also provides that multiple messages, such

as the different statements in the warning for balloons, should be

provided with sufficient space between them, when feasible, to prevent

them from visually blending together. This provision is consistent with

section 6.5.1 of ANSI Z535.4-1991.

Additionally, the type size requirements of Table 1 of 16 CFR

1500.121(c)(2) are primarily designed to cover labeling for hazardous

household chemicals. Accordingly, the correlation between display panel

size and type size stops display panels with an area in excess of 30

square inches. In the case of toys and games, however, the packages in

which such articles are sold or stored are often in excess of 100

square inches. Limiting the minimum type size for precautionary

labeling on such packages to that required for packages with a display

panel of greater than 30 square inches could well result in the

labeling statements becoming inconspicuous. Accordingly, based in part

on type size requirements found in the regulation establishing labeling

standards for electrical toys, 16 CFR 1505.3(d)(2), the Commission has

included in this regulation type size requirements for large packages,

vending machines, and other large containers.

The term ``packages refer to the package in which a product subject

to labeling under section 24 of the FHSA is sold at retail or is

intended to be stored, as well as to any outer container or wrapping. A

package with a principal display panel with an area of 100 square

inches up to, but not including, 400 square inches shall have a signal

word at least \1/4\ of an inch in height. The accompanying statement of

hazard shall be at least \5/32\ of an inch in height, and the other

cautionary statements shall be at least \7/64\ of an inch in height.

With respect to a package with a principal display panel of 400 square

inches or more, the signal word, statement of hazard and other

cautionary labeling shall be \1/2\ inch, \1/4\ inch, and \5/32\ inch in

height, respectively.

Descriptive material that accompanies a product subject to the

labeling requirements shall comply with the requirements of 16 CFR

1500.121(c)(6) relating to literature containing instructions for use

which accompanies a hazardous substance. If the descriptive material

contains instructions for use, the required precautionary labeling

shall be in reasonable proximity to such instructions or directions ad

shall be placed together within the same general area (see 16 CFR

1500.121(c)(6)).

D. Proposed Effective Date

The Commission proposes that this regulation become effective on

January 1, 1995, and shall apply only to products entered into commerce

on or after the effective date. The term ``entered into commerce''

refers to products manufactured in or imported into the United States

after the effective date.

E. Impact on Small Businesses

In accordance with section 3(b) of the Regulatory Flexibility Act,

5 U.S.C. 605(b), the Commission certifies that this regulation will not

have a significant economic impact upon a substantial number of small

entities. Any obligations imposed upon such entities arise under the

express provisions of section 24 of the FHSA. This regulation simply

clarifies the obligations imposed by that law on certain toys, games,

balloons, marbles, and balls. The regulation itself therefore will have

no significant economic impact on small businesses, either beneficial

or negative, beyond that which results from the statutory provisions.

F. Environmental Considerations

The proposed rule falls within the provisions of 16 CFR 1021.5(c)

which designates categories of actions conducted by the Consumer

Product Safety Commission that normally have little or no potential for

affecting the human environment. The Commission does not believe that

the rule contains any unusual aspects which may produce effects on the

human environment, nor can the Commission foresee any circumstance in

which the rule proposed below may produce such effects. For this

reason, neither an environmental assessment nor an environmental impact

statement is required.

G. Preemption of State and Local Requirements

Section 101(e) of the CSPA contains provisions which prohibit any

state or political subdivision of a state from enacting or enforcing

any requirement relating to cautionary labeling of small parts hazards

or choking hazards associated with any toy, game, marble, small ball,

or balloon intended or suitable for use by children unless the state or

local requirement is identical to a requirement established by section

24 of the FHSA or by regulation promulgated by the Commission. Section

101(e) allows a state or political subdivision of a state to enforce a

non-identical requirement relating to cautionary labeling to warn of

small parts hazards or choking hazards associated with any toy subject

to the provisions of section 24 until January 1, 1995, if the non-

identical requirement was in effect on October 2, 1993. The preemptive

provisions of section 101(e) of the CSPA have been included in the text

of the regulation proposed below.

List of Subjects in 16 CFR Part 1500.19

Business and industry, Consumer protection, Hazardous materials,

Infants and children, Labeling, Packaging and containers.

Conclusion

Therefore, pursuant to the authority of the Child Safety Protection

Act of 1994 (Pub. L. 103-267). sections 10(a) and 24(c) of the Federal

Hazardous Substances Act, (15 U.S.C. 1269(a) and 1278(c)), and 5 U.S.C.

553, the Consumer Product Safety Commission proposes to amend Title 16

of the Code of Federal Regulations, Chapter II, Subchapter C, Part 1500

as set forth below.

PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES; ADMINISTRATION AND

ENFORCEMENT REGULATIONS

1. The authority for Part 1500 is amended to read as follows:

Authority: 15 U.S.C. 1261-1278, 2079.

2. Section 1500.18 is amended by revising paragraph (a)

introductory text and by adding paragraph (a)(17) to read as follows:

Sec. 1500.18 Banned toys and other banned articles intended for use by

children.

(a) Toys and other articles presenting mechanical hazards. Under

the authority of sections 2(f)(1)(D) and 24 of the act and pursuant to

the provisions of section 3(e) of the act, the Commission has

determined that the following types of toys or other articles intended

for use by children present a mechanical hazard within the meaning of

section 2(s) of the act because in normal use, or when subjected to

reasonably foreseeable damage or abuse, the design or manufacture

presents an unreasonable risk of personal injury or illness:

* * * * *

(17) Any ball intended for children under three years of age that,

under the influence of its own weight, passes, in any orientation,

entirely through a circular hole with a diameter of 1.75 inches (4.445

cm) in a rigid template. In testing to evaluate compliance with this

regulation, the diameter of opening in the Commission's test template

shall be no greater than 1.75 inches (4.445 cm).

(i) For the purposes of this paragraph, the term ``ball'' includes

any spherical, ovoid, or ellipsoidal object that is designed or

intended to be thrown, hit, kicked, rolled, or bounced. The term

``ball'' includes any spherical, ovoid, or ellipsoidal object that is

attached to such a toy or article by means of a string, elastic cord,

or similar tether. The term ``ball'' also includes any multi-sided

object formed by connecting planes into a generally spherical, ovoid,

or ellipsoidal shape that is designated or intended to be used as a

ball, and any novelty item of a generally spherical, ovoid, or

ellipsoidal shape that is designated or intended to be used as a ball.

(ii) The term ``ball'' does not include dice, or balls permanently

enclosed inside pinball machines, mazes, or similar outer containers.

(iii) In determining whether such a ball is intended for use by

children under three years of age, the criteria specified in 16 CFR

1501.2(b) and the enforcement procedure established by 16 CFR 1501.5

shall apply.

* * * * *

3. A new section 1500.19 is added, to read as follows:

Sec. 1500.19 Misbranded toys and other articles intended for use by

children.

(a) Definitions. For the purposes of this section, the following

definitions shall apply.

(1) Ball means a spherical, ovoid, or ellipsoidal object that is

designed or intended to be thrown, hit, kicked, rolled, or bounced. The

term ``ball'' includes any spherical, ovoid, or ellipsoidal object that

is attached to such a toy or article by means of a string, elastic

cord, or similar tether. The term ``ball'' also includes any multi-

sided object formed by connecting planes into a generally, spherical,

ovoid, or ellipsoidal shape that is designated or intended to be used

as a ball, and any novelty item of a generally spherical, ovoid, or

ellipsoidal shape that is designated or intended to be used as a ball.

The term ``ball'' does not include dice, or balls permanently enclosed

inside pinball machines, mazes, or similar outer containers.

(2) Small ball means a ball that, under the influence of its own

weight, passes, in any orientation, entirely through a circular hole

with a diameter of 1.75 inches (4.445 cm) in a rigid template. In

testing to evaluate compliance with this regulation, the diameter of

opening in the Commission's test template shall be no greater than 1.75

inches (4.445 cm).

(3) Latex balloon means a toy or decorative item consisting of a

latex bag that is designed to be inflated by air or gas. The term does

not include inflatable children's toys that are used in aquatic

activities such as rafts, water wings, life rings, or other similar

items.

(4) Marble means a ball made of a hard material, such as glass,

agate, marble or plastic, that is used in various children's games,

generally as a playing piece or marker.

(5) Small part means any object which, when tested in accordance

with the procedures contained in 16 CFR 1501.4(a) and 1501.4(b)(1),

fits entirely within the cylinder shown in Figure 1 appended to 16 CFR

1501.

(6) Package or ``packaging'' refers to the immediate package in

which a product subject to labeling under section 24 is sold or is

intended to be stored, as well as to any outer container or wrapping.

(7) Descriptive material means any instruction (whether written or

otherwise) for the use of a product subject to these labeling

requirements, any depiction of the product, and any promotional

material, advertisement, or other written literature that describes any

function, use, warnings, user population, design or material

specification, or other characteristic of the product, including its

suitability for use with or its relationship to other games, products,

or toys. Descriptive material ``accompanies'' a product subject to the

labeling requirements when it is packaged with the product or when it

is intended to be distributed with the product at the time of sale or

delivery to the purchaser.

(b) Misbranded toys and children's articles. Pursuant to sections

2(p) and 24 of the FHSA, the following articles are misbranded

hazardous substances if their packaging, any descriptive material that

accompanies them, and, if unpackaged, any bin in which they are held

for sale, any container in which they are held for retail display, or

any vending machine from which they are dispensed fails to bear the

labeling statements required below, or if such labeling statements fail

to comply with the prominence and conspicuousness requirements of

paragraph (d) of this section.

(1) Any toy or game that is intended for use by children who are at

least three years old but less than seven years of age shall bear or

contain the following cautionary statement if the toy or game includes

a small part:

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(2) Any latex balloon, or toy or game that contains a latex

balloon, shall bear the following cautionary statement:

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(3)(i) Any small ball intended for children three years or older

shall bear the following cautionary statement:

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(ii) Any toy or game intended for children three years or older

that contains a small ball shall bear the following cautionary

statement:

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(4)(i) Any marble intended for children three years of age or older

shall bear the following cautionary statement:

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(ii) Any toy or game intended for children three years of age or

older that contains a marble shall bear the following cautionary

statement:

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(c) Age of intended user. In determining the ages of the children

for which any toy or article subject to this subsection is intended,

the following factors are relevant: the manufacturer's stated intent

(such as the age stated on a label) if it is reasonable; the

advertising, marketing, and promotion of the article; and whether the

article is commonly recognized as being intended for children in this

age group. In enforcing this provision, the Commission will follow the

procedures set forth in 16 CFR 1501.5.

(d) Prominence and conspicuousness of labeling statements. The

requirements of 16 CFR 1500.121 relating to the prominence and

conspicuousness of precautionary labeling statements for hazardous

substances shall apply to any labeling statement required under section

1500.19, with the following clarifications and modifications.

(1) All labeling statements required by section 1500.19 shall be in

the English language, and shall appear in the same format and layout as

the statements depicted in paragraphs (b) and (e) appear. The

statements shall be blocked together within a square or rectangular

area, with or without a border. The color of the square or rectangular

area within which the precautionary labeling appears shall be in sharp

contrast to:

(i) the background color of the area of the package on which it

appears,

(ii) to the color of any printed matter in proximity to the

required labeling statements, and,

(iii) if the package is a see-through package, to the primary color

of the article contained in the package. The color of the required

cautionary labeling statements shall be in sharp contrast to background

color of the square or rectangular area in which the labeling appears.

(2) The words ``WARNING'' or ``SAFETY WARNING'' required by section

24 of the FHSA shall be regarded as signal words;

(3) The statement ``CHOKING HAZARD'' shall be regarded as a

statement of the principal hazard associated with the products subject

to the regulation;

(4) All other remaining statements required by this subsection

shall be regarded as ``other cautionary material'' as that term is

defined in 16 CFR 1500.121(a)(2)(viii);

(5) The principal display panel for a bin, container for retail

display, or vending machine shall be the side or surface designed to be

most prominently displayed, shown, or presented to, or examined by

prospective purchasers. Any other side or surface of such a bin,

container for retail sale, or vending machine that bears information,

such as price or product description, for examination by purchasers

shall be deemed to be a principal display panel;

(6) All of the labeling statements required by this subsection,

including those classified as ``other cautionary material,'' must

appear on the principal display panel of the product, except as

provided for by section 1500.19(e). Any signal word shall appear on the

same line and in close proximity to the triangle required by section

24. Any statement of hazard shall appear below the triangle and signal

word and shall be separated from the triangle and signal word by a

distance equal to the height of the signal word. Multiple messages

should be provided with sufficient space between them, when feasible,

to prevent them from visually blending together;

(7) All labeling statements required by this subsection shall

comply with the type size requirements of Table 1 of 16 CFR

1500.121(c)(2) except as follows:

(i) If the principal display panel has an area of 100 square inches

up to, but not including, 400 square inches, the signal word shall be

at least \1/4\ of an inch in height. The accompanying statement of

hazard shall be at least \5/32\ of an inch in height, and the other

cautionary statements shall be at least \7/64\ of an inch in height;

(ii) If the principal display panel is 400 square inches or more,

the signal word, statement of hazard and other cautionary labeling

shall be at least \1/2\ of an inch in height. The accompanying

statement of hazard shall be at least \1/4\ of an inch in height, and

the other cautionary statements shall be at least \5/32\ of an inch in

height.

(8) Labeling required by this subsection that appears on a bin,

container for retail display, or vending machine shall be in reasonable

proximity to any pricing or product information contained on the

principal display panel, or, if such information is not present, in

close proximity to the article that is subject to the labeling

requirements.

(9) Descriptive material that accompanies a product subject to the

labeling requirements, including accompanying material subject to the

alternative allowed by section 1500.19(f), shall comply with the

requirements of 16 CFR 1500.121(c)(6) relating to literature containing

instructions for use which accompanies a hazardous substance. If the

descriptive material contains instructions for use, the required

precautionary labeling shall be in reasonable proximity to such

instructions or directions and shall be placed together within the same

general area (see 16 CFR 1500.121(c)(6)).

(10) In the case of any alternative labeling statement permitted

under section 1500.19(e), the requirements of 16 CFR 1500.121(b)(3) and

1500.121(c)(2)(iii) shall apply to statements or indicators on the

principal display panel directing attention to the complete cautionary

labeling that appears on another display panel.

(11) Any triangle required by this subsection shall be an

equilateral triangle. The height of such a triangle shall be equal to

or exceed the height of the letters of the signal word ``WARNING''. The

height of the exclamation point inside the triangle shall be at least

half the height of the triangle, and the exclamation point shall be

centered vertically in the triangle. The triangle shall be separated

from the signal word by a distance at least equal to the space occupied

by the first two letters of the signal word. In all other respects, the

triangles with exclamation points shall confirm generally to the

provisions of 16 CFR 1500.121 relating to signal words.

(e) Alternative labeling statements for small packages. Any

cautionary statement required by section 1500.19(b) may be displayed on

a display panel of the package of a product subject to the labeling

requirement other than the principal display panel only if:

(1) the package has a principal display panel of 15 square inches

or less,

(2) the full labeling statement required by paragraph (b) of this

section is displayed in three or more languages on another display

panel of the package of the product, and

(3)(i) In the case of a toy or game subject to section

1500.19(b)(1), a small ball subject to section 1500.19(b)(3), a marble

subject to section 1500.19(b)(4), or a toy or game containing such a

ball or marble, the principal display panel of the package bears the

statement:

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and bears an arrow or other indicator pointing toward or directing the

purchaser's attention to the display panel on the package where the

full labeling statement appears, or

(ii) In the case of a balloon subject to section 1500.19(b)(2) or a

toy or game containing such a balloon, the principal display panel

bears the statement:

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and bears an arrow or other indicator pointing toward or directing the

purchaser's attention to the display panel on the package where the

full labeling statement appears.

(f) Alternative for Products Manufactured Outside the United

States. In the case of a product subject to the labeling requirements

of section 1500.19(b) which is manufactured outside the United States

and is directly shipped from the manufacturer to the consumer by United

States mail or other delivery service in an immediate package that

contains descriptive material, the descriptive material inside the

immediate package of the product need not bear the required labeling

statements only if the shipping container of the product contains other

accompanying material that bears the required statements displayed in a

prominent and conspicuous manner.

(g) Preemption. Section 101(e) of the Child Safety Protection Act

of 1994 prohibits any state or political subdivision of a state from

enacting or enforcing any requirement relating to cautionary labeling

addressing small parts hazards or choking hazards associated with any

toy, game, marble, small ball, or balloon intended or suitable for use

by children unless the state or local requirement is identical to a

requirement established by section 24 of the FHSA or by 16 CFR 1500.19.

Section 101(e) allows a state or political subdivision of a state to

enforce a non-identical requirement relating to cautionary labeling

warning of small parts hazards or choking hazards associated with any

toy subject to the provisions of section 24 until January 1, 1995, if

the non-identical requirement was in effect on October 2, 1993.

Dated: June 28, 1994

Sadye E. Dunn,

Secretary, Consumer Product Safety Commission.

[FR Doc. 94-16082 Filed 6-30-94; 8:45 am]

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