[Federal Register: July 1, 1994]


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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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