[Federal Register Volume 59, Number 126 (Friday, July 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16082]


[[Page Unknown]]

[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.

-----------------------------------------------------------------------

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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