Federal Register, Volume 60 Issue 38 (Monday, February 27, 1995)

[Federal Register Volume 60, Number 38 (Monday, February 27, 1995)]
[Rules and Regulations]
[Pages 10742-10756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4484]

[[Page 10741]]

_______________________________________________________________________

Part VII

Consumer Product Safety Commission

_______________________________________________________________________

16 CFR Part 1500

Ban Small Balls Intended for Children Younger Than Three Years of Age
and To Require Labelling of Certain Toys and Games; Final Rule

Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 /
Rules and Regulations
[[Page 10742]]

CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1500

Final 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: Final 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, inter alia, imposes labeling requirements on certain 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.
Although the requirements imposed by the amendments are generally self-
executing, the Commission is publishing this regulation 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: This regulation becomes effective on August 28, 1995 for
products manufactured or imported into the United States.

FOR FURTHER INFORMATION CONTACT: Francis Krivda, Compliance Officer,
Office of Compliance and Enforcement, Consumer Product Safety
Commission, Washington, D.C. 20207-0001; telephone (301) 504-0400, ext.
1372.

SUPPLEMENTARY INFORMATION:

A. Background

1. Previous Commission Actions
In 1979, the Commission issued regulations to ban toys and other
articles which are intended for use by 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
1500.50-1500.53.
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.
The origins of the CSPA rest in rulemaking activities in which the
Commission engaged between 1988 and 1992. In 1988, the Commission
published an advance notice of proposed rulemaking (ANPR) to initiate
regulatory action to enlarge the dimensions of the cylinder used to
evaluate whether toys or other articles intended for children under
three contain small parts that could present a choking hazard. In 1990,
the Commission terminated that proceeding. It determined that the use
of the test cylinder specified in the existing small parts regulation
had been effective in preventing choking deaths and injuries to
children under three associated with toys intended for that age group.
At the same time, however, the Commission published four ANPRs that,
inter alia, solicited preliminary comment on proposals to require
labeling on small balls, balloons, marbles, and toys and other articles
with small parts intended for children aged three to approximately six.
In 1991, after analyzing the comments received in response to the
ANPRs, the Commission staff recommended that the Commission propose
rules prescribing labeling under the FHSA for the products that later
became the subject of the CSPA. The Commission, however, terminated all
four proceedings because it felt that it could not make the findings
required by the FHSA.

2. The Child Safety Protection Act

On June 16, 1994, Congress enacted the CSPA. The legislation
establishes substantially the same labeling requirements for balloons,
marbles, small balls, and toys and games containing small parts that
the staff recommended in 1991. The primary purpose of the legislation
is to warn purchasers of the potential hazards for children under three
that products intended for older children may present. The CSPA
prescribes labeling statements for balloons, for balls with a diameter
of 1.75 inches or less (``small balls'') and marbles intended for
children three years or over, and for toys or games that contain such
items. The law also requires labeling for toys or games that contain
small parts and that are intended for children at least three years old
but not older than six. Under the CSPA, small balls intended for
children under three are banned. The statute specifies the text of the
required label statement for each of the enumerated products and
requires that labeling appear on the principal display panel of product
packages. For unpackaged, unlabeled items sold in bulk, any bin in
which they are displayed, and any container for retail display or
vending machine from which they are sold or dispensed must bear the
required labeling. The law also directs the Commission to promulgate
regulations to implement the statutory requirements.
On July 1, 1994, the Commission published in the Federal Register a
proposed rule (59 FR 33932). The proposed rule clarified and
interpreted certain provisions of the CSPA. It included definitions of
terms such as ``ball,'' ``small part,'' and ``descriptive material,''
and established criteria for determining the age of children for which
a game or toy is intended. It also clarified the applicability of the
type size and conspicuousness requirements of the regulation codified
at 16 C.F.R. 1500.121 to the products that are subject to the CSPA. It
further contained provisions to assure that labeling statements would
appear prominently on product packages.

B. Response to Comments

In response to the proposed rule, the Commission received almost
300 comments, most from individual consumers. Major consumer groups
supported many of the provisions of the [[Page 10743]] rule as written
and recommended strengthening others. Many individual members of those
organizations submitted comments supporting the rule as drafted.
Approximately twenty manufacturers, trade associations, and firms that
test toys commented on the proposed labeling requirements for toys and
games, while other commenters addressed issues such as the
applicability of the CSPA to writing and art materials and to balloons
distributed by individual performers or sold individually. Other
comments raised issues relating to labeling for unpackaged products
sold or distributed in bulk or requested clarification of specific
technical requirements established by the act or the proposed
regulation. Comments on specific parts of the rule and the Commission's
responses to the comments are discussed in the following paragraphs.
1. Relationship of the CSPA to Other Standards

Representatives of foreign toy manufacturers commented generally on
the complications the legislation presents with regard to standardized
labeling statements under the European toy safety directive and to the
development and use of a graphic symbol to identify products that are
hazardous to children under three. Inasmuch as Congress mandated in the
CSPA the precise labeling requirements that products in the U.S. market
must meet, the Commission has little ability to address these concerns.
Thus, no changes have been made to the final rule concerning these
issues.

2. Existing Policies With Respect to Labeling and Toys

A recurring question throughout the comments is the extent to which
the Commission, in administering the CSPA, intends to apply its
existing policies and interpretations with respect to labeling and toys
generally. For example, commenters inquired whether they can combine
the warning statements required for marbles and for games with small
parts, if they produce a game that contains both items.
Under the general labeling provisions of 16 CFR 1500.127, the
Commission permits information relating to a specific hazard associated
with a hazardous substance to be combined with information relating to
additional hazards if the resulting statement contains all the
information needed to deal with each respective hazard. If the
Commission followed its existing policies, the labeling for the game
could be condensed to reflect the hazard associated with the small
parts and the marble in one statement.
Similarly, under the Commission's small parts testing regulations,
toys reasonably intended to be assembled by an adult and not intended
to be taken apart by a child are tested only in the assembled state, if
the shelf package and assembly instructions prominently indicate that
the article is intended to be assembled only by an adult. The effect of
this exception is to exempt from the small parts test the hardware used
to assemble the toy. If the Commission follows this policy with respect
to the labeling required by the CSPA, products containing such hardware
would also be exempt from the labeling requirements.
The majority of the Commission's policies applicable to toys have
evolved over the last ten to fifteen years, while many of the labeling
policies are twenty to thirty years old. All of the policies provide
standardized points of reference, both for regulated industries as well
as the Commission staff, and take into account the requirements of the
law, the objective of protecting the public, and the practical
realities of the commercial world.
To avoid the confusion associated with establishing differing
requirements for similar toys and labels, in administering the labeling
provisions of the CSPA, the Commission will generally apply its
existing policies with respect to children's articles and hazardous
substances labeling. This general rule will apply unless such a policy
(1) conflicts with the express provisions of the CSPA; (2) is
overridden by a policy decision of the Commission as expressed in the
final rule or in subsequent guidance to the staff of the Commission;
(3) is impractical in its application; or (4) could result in a
diminution of the protection envisioned by the law. The Commission
believes it unlikely, however, that either of the latter two exceptions
will occur.

3. Upper Age Limit

a. Toys and Games
The CSPA establishes labeling requirements for any toy or game that
includes a small part and that is intended for use by children who are
at least three years old but not older than six. The law permits the
Commission to establish an alternative age to the upper limit of six
years, but that alternative limit ``may not be less than five years of
age.'' 15 U.S.C. 1278(a)(1). In the proposed rule, the Commission
declined to establish an alternative upper age limit. As explained
below, the final rule adopts an upper age limit of less than six years.
Consumer advocates supported maintaining the upper age limit at six
years, arguing that, in the absence of compelling evidence to the
contrary, the upper age limit specified in the statute should control.
Several industry commenters, however, objected to applying the labeling
requirements to toys or games intended for use by children under seven
years of age (i.e while they are six years old). These commenters
argued that this upper age limit departed from the original 1991 staff
recommendation that the Commission require labeling on toys or games
intended for children aged from 36 months up to, but not including, 60
months. Most of these commenters suggested that the Commission select
an alternative upper age limit of not more than five years, although
some suggested that the Commission adopt the upper age limit in the
original staff recommendation.
Other commenters argued that the upper age limit of six is
inconsistent with the Commissions's Guidelines for Relating Children's
Ages to Toy Characteristics which the Commission uses to evaluate toys
or other articles intended for use by children. According to these
commenters, the inconsistency arises because the guidelines
differentiate products intended for children aged 37 through 72 months
from those intended for children 73 through 96 months old. The
commenters contended that, if manufacturers complied with the labeling
requirements and also followed the guidelines, the practical effect of
applying the labeling to products intended for children under the age
of seven would be to require labeling for products intended for
children between the ages of 73 and 96 months.
At the outset, neither the CSPA nor its legislative history contain
an explanation of the reason for the statutory upper age limit of six
years or for the floor of five years on the alternative age limit. The
text of the legislation, however, expressly forecloses using the
original staff recommendation to label toys and games intended for
children up to, but not including, 60 months of age as the alternative
upper age limit. Similarly, any alleged inconsistency between the
Commission age grading guidelines and the labeling requirements of the
CSPA arises because the statute itself establishes a presumptive upper
age limit of six years for labeling that does not coincide with the age
divisions in the guidelines. The Commission is, of
[[Page 10744]] course, bound to follow the requirements of the law.
The original staff recommendation did not suggest labeling products
for children five years of age or older because available data did not
support the need to extend the labeling requirements to products
intended for that age group. That recommendation therefore does not
itself provide a basis for specifying a specific alternative upper age
between five and seven years. However, the Commission believes that the
rationale for the original proposal--that the products most likely to
present a threat to children under three are toys and games intended
for three and four year olds, and that the skills, levels of
development and play interests of children five years of age and older
differ significantly from those of such younger children--is valid.
Thus, the Commission believes that establishing an upper age limit
lower than six would not significantly compromise the safety of
children under three.
An upper age limit of 5 years (e.g., under 60 months and one day)
would most closely approximate the objectives of the original staff
recommendation. However, since there is no clearly defined line between
toys intended for four year olds and those intended for five years
olds, drawing a distinction in the rule in effect based on the day
after a child reaches his or her fifth year could create problems for
manufacturers in complying with the law. In contrast, an upper age
limit of less than 6 years (less than 73 months) would be consistent
with the Commission's Guidelines for Relating Children's Ages to Toy
Characteristics. Those established guidelines recognize a break between
toys and games intended for children 37 months through 72 months old
(less than 6 years old), and those intended for children 73 (6 years
old) through 96 months.
The Commission has therefore lowered the upper age limit to apply
to toys or games intended for use by children who are less than six
years old. In addition to the reasons discussed above, the Commission
believes that limiting the scope of the labeling requirement will more
closely focus prospective purchasers on the potential hazards of those
toys and games intended for older children that are most likely to be
purchased for younger children. Moreover, many toys intended for
children six years of age are also intended for children seven and
eight years of age. While the great majority of these products are
unlikely to be purchased for children under three, labeling all of
these products could dilute the effectiveness of the labeling on
products intended for children from three up to six years of age that
are most likely to be purchased for younger children.
b. ``Younger Than Seven Years''
The preamble to the proposed rule points out that products intended
for children of a specific age are generally recognized by consumers as
being suitable for all children of that age. Thus, a toy labeled for
use by children six years old is typically viewed as being appropriate
for use by children who have just turned six, as well as for use by
those approaching their seventh birthday. The proposed rule interpreted
the term ``intended for use by children who are * * * not older than
six years'' in the CSPA to mean that the labeling requirements apply to
toys or games intended for children under seven years of age.
Several commenters disagreed with this approach. Some contended it
was inconsistent with the Commission's age grading guidelines. Others,
relying on the statutory upper age limit of six years, suggested that
the interpretation in the proposed rule would lead manufacturers who
currently label products for children age six and up in accordance with
industry standard practice to revise the age recommendations to seven
and up.
None of the commenters provided a basis for changing the
interpretation. This approach is the same as that of the Commission's
small parts regulation which applies to products intended for children
under three years of age. Moreover, applying the labeling requirements
to products intended for use by children who have not yet reached a
specific age--in this case, six--is consistent with the analytical
approach of the Commission's age grading guidelines. For example, a
child does not attain the age of six years until the completion of the
last day of his or her seventy-second month (i.e., is beginning the
seventy-third month). Thus, the upper end of 72 months in the age
grouping of 37 to 72 months specified in the guidelines, in effect,
applies to articles intended for children who are in the midst of their
fifth year but have not yet reached their sixth year, i.e. are under
six years of age. The Commission, therefore, declines to modify the
final rule in the manner requested by the commenters.

4. Prominence and Conspicuousness of Labeling

Under the CSPA, precautionary labeling statements must be displayed
in the English language in conspicuous and legible type in contrast by
typography, layout, or color with other printed material on a product
package, on any accompanying descriptive material, on any bin or
container for retail display from which the product is sold, and on any
vending machine from which it is dispensed. The act also requires that
the labeling statements be displayed ``in a manner consistent with part
1500 of title 16, Code of Federal Regulations.'' 15 U.S.C.
1278(c)(1)(B). Title 16, Part 1500.121, contains the Commission's
policies and interpretations implementing section 2(p)(2) of the FHSA
which requires that precautionary labeling for hazardous substances
appear prominently and conspicuously. The proposed rule incorporated by
reference those policies and interpretations, with modifications
designed to accommodate specific provisions of the CSPA and the general
differences between toy labels and hazardous substance labels.
No commenter objected to incorporating the provisions of 16 CFR
1500.121 by reference in the proposed rule. Consumer advocates favored
publishing the proposed requirements in final without change. Several
industry commenters, however, objected to specific provisions in the
proposed rule modifying 16 CFR 1500.121. Those objections and the
Commission's response are discussed below.
a. ``Color-Blocking''
To assure that the labeling statements required by the CSPA appear
prominently and conspicuously, the proposed rule solicited comments on
the desirability of ``color-blocking'' those statements. Color-blocking
would require the statements to appear on a background different from
the color of the background of the area of the package on which it
appears, from the color of any printed matter in proximity to the
required statements, and, if the package were a see-through package,
from the color of the article contained in the package. As the proposed
rule explained, the packages of products subject to the CSPA generally
contain many visual messages, some in printed product descriptions and
depictions, others in see-through features that display actual
products. All of these features have the potential to obscure labeling
statements which, if they generally followed the provisions of 16 CFR
1500.121, would otherwise be regarded as conspicuous.
Several commenters objected to the ``color-blocking'' proposal,
contending that it is more stringent than the current conspicuousness
requirements contained in 16 CFR 1500.121. They also contended that
requiring color- [[Page 10745]] blocking would unnecessarily increase
the size of blister packaging used for small products and hinder tri-
lingual labeling under the North American Free Trade Agreement (NAFTA).
The commenters argued that applying the existing provisions of 16 CFR
1500.121 to products subject to CSPA labeling would be adequate to
assure that the labels are conspicuous.
The CSPA requires that the labels it prescribes must be displayed
conspicuously in a manner consistent with part 1500 of title 16 of the
Code of Federal Regulations. The law does not require that the
conspicuousness requirements for the labels of toys and games be
identical to any similar requirement in the existing regulations.
Accordingly, while the proposed regulation incorporated certain
provisions of 16 CFR 1500.121, it also contained variations that take
into account the requirements of the legislation itself and the
lithography and design features of packages for toys and games. The
``color-blocking'' proposal was one variation.
The conspicuousness of a labeling statement depends on a variety of
factors, including the location of the statement on the package and the
types of printed material in proximity to it. While ``color-blocking''
is one technique to assure that labeling is conspicuous, the Commission
believes that the use of this method in all cases may be unnecessary to
accomplish the objectives of the CSPA. As is discussed below, two
provisions of the existing conspicuousness regulations provide adequate
assurance that labels required by the CSPA will be conspicuous without
requiring the use of color-blocking.
The Commission's existing policy in 16 CFR 1500.121(b)(2)(ii)
requires that labeling statements that appear on a principal display
panel be blocked together within a square or rectangular area with or
without a border. The statements must be separated on all sides from
other printed or graphic matter by a space no smaller than the minimum
allowable height of the type size for precautionary labeling other than
signal words and statements of principal hazard (e.g. the statement
``Not for children under three yrs.'' in the CSPA). If not separated by
that distance, the labeling statements must be surrounded by a border
line. With regard to other cautionary material, 16 CFR 1500.121(d)(2)
specifies that the label design, the use of vignettes, or the proximity
of other labeling or lettering shall not be such that any cautionary
labeling statement is obscured or rendered inconspicuous.
The Commission has revised the final regulation to eliminate the
requirement for color-blocking. Instead, the labeling must also conform
to the spacing/borderline requirements of 16 CFR 1500.121(b)(2)(ii) for
principal display panel labeling. This means that, if a border line is
used, it must be rectangular or square in shape. If no border line is
used, other printed or graphic material should be separated from the
cautionary labeling statements in a manner that makes the precautionary
statements appear in a square or rectangular area. If other printed or
graphic material appears on less than four sides of the cautionary
material, the other printed or graphic material on any side should be
laid out in a manner that creates the appearance of a vertical or
horizontal line of separation, as appropriate, between that material
and the cautionary labeling.
The Commission believes that the latter measures will adequately
assure the conspicuousness of labeling for almost every product subject
to the CSPA. Recognizing, however, that it is impossible to anticipate
the design or lithography of every package, the final regulation
includes a provision similar to that of 16 CFR 1500.121(d)(2) relating
to interference with precautionary labeling by label design, the
proximity of other labeling, or vignettes. The practical effect of this
provision is that all labeling mandated by the CSPA must appear on a
solid background, although the color of that background need not differ
from the background color of the rest of the package label as long as
the precautionary statements appear conspicuously. The inclusion of
this provision will also permit the Commission to take action, should
the spacing/borderline provisions be inadequate in a specific case to
make the labeling required by the CSPA conspicuous.
b. Principal Display Panel/Multiple Type Sizes
The proposed rule established minimum type sizes for the various
labeling statements required by the CSPA based upon the area of the
display panel upon which those statements appear. For smaller packages
with display panels of less than 100 square inches, the regulation
followed the type size charts of Table 1 of 16 CFR 1500.121(c)(2) which
generally apply to the labels of hazardous substances packaged in
containers up to one gallon in volume. For larger packages, the
regulation followed the minimum lettering heights of 16 CFR
1505.3(d)(2) which apply to labels on packages for electrically
operated toys.
1. See-Through Features: Several commenters requested clarification
of the definition and the measurement of the area of principal display
panels. A number argued that the measurement of the area of the
principal display panel should exclude the area of see-through
features, contending that including this area in the measurement would
result in labels that are too large. The Commission declines to accept
this recommendation.
The Commission's existing policies require that the area of a see-
through feature be included in measuring the area of a principal
display panel. This is because see-through features are incorporated
into packages to permit consumers to see the item for sale in
conjunction with the labeling that accompanies the item. Such a feature
often includes background graphics designed to promote specific
attributes of the item that is visible through the feature or to show
the item in an action setting. Like written descriptions or printed
depictions of the products that generally appear on the packages of
toys or games, see-through features communicate to prospective
purchasers details about the products contained therein. Accordingly,
the Commission views see-through features as functioning as part of the
label of the product. To assure that the precautionary statements
required by the CSPA are conspicuous and that a see-through feature
does not direct a prospective purchaser's attention away from those
statements, the area of the see-through feature is included in
computing the area of the principal display panel to determine the
proper type size.
The Commission, however, distinguishes packages with see-through
features from peg-board packages consisting of a cardboard header with
an attached plastic bag containing the item for sale. In the latter
instance, all of the graphic material typically appears on the
cardboard header separated from the item, making the header the
principal display panel of the package. If a manufacturer chooses to
place precautionary labeling on the header, the area of the surface of
the header designed to face outward at retail controls the type size of
the labeling. If, however, a manufacturer chooses to place
precautionary labeling on the plastic bag, the bag itself becomes part
of the principal display panel and its area is included along with that
of the header in determining the appropriate type size. For peg board
packages consisting of a header and a plastic bag which contains
multiple individually packaged products, some of which may
[[Page 10746]] require labeling, labeling each individual package that
contains a product requiring labeling is sufficient to comply with the
law, as long as the label is visible through the outer bag and is
conspicuous. The type size of the statement would be based on the area
of the individual bag containing the item, rather than on the area of
the outer plastic bag.
2. Vending Machine Display Panels: Representatives of vending
machine interests questioned what the principal display panel of a
vending machine is, noting that, generally, labeling may appear either
on the glass or clear plastic container of the machine or on a display
card intended to be inserted in a holder in the machine. The commenters
suggested that, if the machine has a display card that contains graphic
material, the card itself constitutes the principal display panel. In
the absence of such a card, the front of the container would be the
principal display panel. The type size of the required labeling
statements would depend on the area of the surface treated as the
principal display panel. The Commission agrees that this approach is
appropriate and has revised the final regulation accordingly.
3. Type Size for Large Packages: Some commenters objected to the
use of letter sizes specified in the electrical toy regulation for
large packages. The commenters contended that the type sizes prescribed
for packages with an area in excess of 30 square inches (approximately
the size of a gallon container) in 16 CFR 1500.121(c)(2) are adequate
for larger packages, including those with an area in excess of 400
square inches. One commenter argued that the larger type sizes
prescribed in the proposed regulation are inappropriate for products
subject to the CSPA which, unlike electrical toys, do not present a
hazard to the intended user. That commenter also submitted mock-up
labels which purported to represent how the labels would actually
appear if they complied with the larger type size requirements of the
proposed regulation. It also submitted other mock-up labels purporting
to demonstrate that the use of smaller type size on large packages
could still result in conspicuous labels. As was argued with color-
blocking, other commenters contended that the use of larger type sizes
would increase the size of blister packaging for small products and
would hinder tri-lingual labeling under NAFTA.
The Commission believes that the commenters' objections and
concerns are unfounded and has adopted the proposed type size
requirements in the final rule. Labeling cannot be effective unless it
attracts the attention of consumers. Both 16 CFR 1500.121 and the
labeling provisions of the electrical toy regulation follow the
established principle that scaling the size of type to the display
panel area on which it appears is essential to accomplish this
objective. The type size requirements of 16 CFR 1500.121 are designed
to accommodate the relatively small packages used for products such as
household cleaners. The electrical toy regulation, which has been in
effect for over twenty years, expressly addresses the issue of the size
of labeling for larger packages similar to those in which many products
covered by the CSPA are marketed. The commenters did not adequately
explain why the Commission should accede to smaller type sizes for
products in large packages which could, in many cases, make labeling
statements required by the CSPA inconspicuous. The Commission notes
that the commenters' attempt to distinguish the electrical toy labeling
requirements from those required by the CSPA on the basis of hazard to
the intended user is not persuasive. The labeling required by the
electrical toy regulation states in part ``CAUTION--ELECTRIC TOY: Not
recommended for children under ______ years of age * * *'', a statement
which has substantially the same purpose as the labels prescribed by
the CSPA.
With respect to the ``mock-up'' labels submitted by one commenter,
the proposed regulation only specified the minimum height of the
letters in a precautionary labeling statement. However, the
conspicuousness of a label statement also depends on the style of type
used, as well on the ratio of the height of the letters in the
statement to their width and the spacing between the letters. The
``mock-up'' labels that the commenter submitted to demonstrate that the
type size in the proposed rule for packages with a display panel in
excess of 100 square inches was ``too large'' used a heavy, bold-faced
type, with an approximate two-to-one height-to-width ratio for the
letters, and normal spacing between the letters. In contrast, the
labeling requirements of 16 CFR 1500.121(c)(3), incorporated by
reference in the proposed rule, only require that the height-to-width
ratio not exceed three to one, and are silent on type style and letter
spacing. Thus, while a manufacturer is free to use a label similar to
the ``mock-up'' labels presented by the commenter, the regulation does
not require it, nor would following the provisions of the proposed rule
with respect to large packages necessarily produce the result displayed
by the mock-up labels that the commenter viewed as undesirable.
The same commenter also submitted other mock-up labels purporting
to demonstrate that the use of smaller type size on large packages
could still result in conspicuous labels. Again, in addition to letter
height, type style, height-to-width ratio, and spacing all play a major
role in making labels conspicuous. The Commission agrees that certain
combinations of these factors coupled with sharply contrasting colors
may tend to make smaller type more conspicuous. However, in the absence
of requirements in the regulations specifying type style, spacing,
etc., there is no assurance that the use of smaller type will result in
a conspicuous label.
With respect to the allegation that the type sizes specified in the
rule for large packages will require that the size of blister packaging
for small products be increased, those type sizes have, for years, been
accepted as striking a reasonable balance to assure that warnings are
conspicuous while providing ample space for other graphic material. In
the Commission's view, while changes in lithography may be required to
meet the requirements of the CSPA, there is no evidence that compliance
will require increasing package sizes.
4. Blister Cards: One commenter suggested that the Commission
permit blister cards to be labeled either on the front of the card or
the back, reasoning that parents are just as likely to read the
information on the back of the card as they are the information on the
front. The Commission declines to accept this suggestion. The law
requires that the principal display panel--the front of a blister
card--be labeled. Moreover, the intent of the CSPA is to provide point-
of-purchase warnings. There is no evidence that parents will read the
back of a blister card prior to purchase. Moreover, in the case of
articles like dolls or toy cars which are generally not accompanied by
instructions, the Commission believes it unlikely that purchasers will
read the back of the card at all.
c. Multiple Label Statements
Several commenters expressed concern that the proposed rule would
require a toy or game that contained multiple articles subject to the
labeling requirements of the CSPA to bear the complete text of each
label specified in the act addressing the hazard associated with each
article. The proposed regulation did not address this issue. For
clarity, the Commission has revised [[Page 10747]] the final regulation
to incorporate a provision similar to 16 CFR 1500.127(b) which permits
labeling information relating to multiple hazards to be condensed as
long as the resulting statement contains all of the information
necessary to deal with the specific hazard presented by each article.
The Commission notes, however, that the message contained in the
balloon label specified in the CSPA differs substantially from those in
the labels for balls, marbles, and toys and games with small parts.
Therefore, the label of a package that contains a balloon and another
item subject to the CSPA may only have a combined signal word and
statement of hazard. The remaining statements required by the act with
respect to each of the products in the package must appear on the label
of the package.
d. Label Justification, Layout and Spacing
The proposed rule required that labels required by the CSPA appear
in the same format and layout as that prescribed in the legislation
itself. Several commenters objected to this requirement, noting the
Senate Report on the legislation would have permitted labels to vary
from the precise format specified in the law. One commenter questioned
whether the statutory format requirements included margin
justification.
The requirement in the proposed rule was based on the precision
with which the law identifies the text and format of the various
labeling statements. The rule construed that precision as an express
indication of how Congress intended those statements to appear on
package labels. However, when taken in conjunction with the
Congressional mandate that the Commission's regulations for the
conspicuousness of labeling required by the CSPA be consistent with 16
CFR 1500.121, the Commission believes that a more valid reading of the
legislation would treat the format and layout of the various labeling
statements in the law as exemplary, rather than mandatory.
While the label format set forth in the law is more than adequate
to meet the Commission's existing conspicuousness regulations, it does
not take into account variations in packaging design and lithography
that the Commission can expect to encounter for products subject to the
CSPA. On balance, the existing policies implementing the labeling
requirements of the FHSA have proven adequate to ensure that labels are
prominent and conspicuous. Thus, the Commission has revised the
proposed rule to delete the requirement that manufacturers follow the
precise format in the statute and instead will follow its existing
labeling policies with respect to format and layout. The Commission
however notes that one existing policy states that labeling statements
shall appear blocked together within a square or rectangular area. This
means that the labeling statements required by the act must appear on
at least two lines. Since the resolution of the overall issue of format
also resolves the question of margin justification, no response to that
comment is necessary.

5. Descriptive Material

The CSPA requires the statutory warnings to appear on descriptive
material accompanying a product that requires labeling under the act.
The proposed regulation defined the term ``descriptive material'' as
``any instruction (whether written or otherwise) for the use of the
product, any depiction of the product, and any promotional material,
advertisement, or other written literature that describes any function,
use, warnings, user population, or other characteristic of the product,
including its suitability for use with or relationship to other games,
products, or toys.'' The proposed regulation also noted that
descriptive material ``accompanies'' a product when it is packaged with
the product or is intended to be distributed with the product at the
time of sale or delivery to the purchaser. As is discussed below, the
final rule retains much of the definition, but clarifies that catalogs
and marketing materials that describe products other than a regulated
product generally need not be labeled.
a. Meaning of ``Accompanies''
Several commenters expressed concern that the definition of the
term ``descriptive material'' in the proposed regulation might require
multiple labels on product packages such as blister cards that, for
example, contain instructions for use or recommended age labeling on
the back of the cards. As the discussion of the term ``accompanies'' in
the proposed rule indicates, the Commission believes that Congress
intended labeling requirements for descriptive material to apply to
material separate from the package of the article itself, such as an
instruction sheet. The final regulation clarifies this point.
Another commenter questioned whether material such as mail order
catalogs or newspaper advertisements depicting items subject to the
CSPA are required to bear the required warning statements. The act only
requires descriptive material which accompanies a regulated product to
be labeled. According to the proposed regulation, descriptive material
``accompanies'' a product 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. A catalog or advertisement that does not
meet either of these criteria would not require labeling.
b. Instructions for Use
Several commenters contended that the definition of the term
``descriptive material'' in the proposed rule was too expansive. Some
requested that the definition be limited to material containing
instructions for use.
Section 2(n)(2) of the FHSA expressly requires that labeling
required by the act appear ``* * * on all accompanying literature where
there are instructions for use, written or otherwise.'' Inasmuch as the
CSPA follows the general labeling scheme of the FHSA, the Commission
believes that the use of the term ``descriptive material'' without the
limitation contained in section 2(n) indicates a Congressional
intention that CSPA labeling not be limited to material containing
instructions for use. Accordingly, the Commission declines to adopt the
revision requested by the commenter to limit the labeling requirements
to written material containing instructions for use.
The Commission notes that the great majority of material that
accompanies the products subject to the CSPA contains instructions for
use, either with or without other descriptions. Moreover, each discrete
piece of material accompanying a regulated product need only have one
label. Thus, if a piece of accompanying literature contained, for
example, instructions for use, a statement of the age of the children
for whom an item is intended, and a depiction of the product, only one
precautionary statement would be required. Therefore, the Commission
believes that defining the term ``descriptive material'' broadly to
include the variety of ways that accompanying material can describe or
depict a regulated product should have little practical effect.
c. Catalogs and Marketing Materials
Many industry commenters contended that catalogs and marketing
materials depicting other products, as well as the regulated products
that such materials accompany, should be exempt from the labeling
requirements. Under their rationale, the purpose of such catalogs is to
focus the attention of the purchaser on the other products rather
[[Page 10748]] than on the regulated product he or she has just
purchased.
First, the law only applies to descriptive material that
accompanies a product that requires labeling. A catalog that
accompanies an unregulated product need not bear any labeling, even
though the packages of other products described in the catalog might
require labeling.
The status under the CSPA of a marketing material such as a catalog
that depicts or advertises other items in addition to the regulated
product that the catalog accompanies is a question of interpretation.
Although a depiction of a regulated product in a catalog would appear
to meet the plain meaning of the term ``descriptive material,'' the
Commission believes that requiring labeling in such a circumstance will
do little to increase the protection provided by the point-of-purchase
warning on the product's label. Accordingly, the Commission has
excluded such catalogs and similar marketing materials from the
definition of ``descriptive material,'' unless they contain additional
information, such as instructions for use of the regulated product it
accompanies or a list of accessories intended to be used solely with
that product.
d. Descriptive Material Intended for Use by Children
Some commenters recommended that descriptive material intended for
use by children not require precautionary labeling, if the warnings are
included on a separate package insert intended for adults. The
commenters, citing the Senate report, reasoned that the statutory
warnings are intended for adult purchasers and that young children
would be unable to understand and appreciate the hazards. Consumer
advocates, however, favored requiring that such material be labeled,
noting that the material is often read by adults even though it is
intended for children and that many children are capable of reading and
understanding the warnings.
The Commission believes that the inclusion of a properly labeled
insert in addition to instructions for children is adequate to satisfy
the objectives of the legislation without compromising safety. The
final rule exempts from the labeling requirements descriptive material
intended solely for use by children, provided that the package of the
product also contains a properly labeled insert intended for adults
that is prominently identified as a warning for parents.

6. Definition of Package

The proposed regulation defined the term ``package'' as the
immediate package in which a product subject to labeling is sold or is
intended to be stored, as well as to any outer container or wrapping.
Commenters expressed concern that this definition could require
labeling to appear on shrink wrap or cellophane applied over an
immediate package, as well as on components of toys such as doll
houses, toy medical bags, etc. that are themselves used to store other
components. One commenter also suggested that the labeling requirements
not apply to containers used to ship packaged products to retailers
because consumers generally do not see or read information on such
containers.
In response to the latter comment, the Commission notes that the
CSPA only applies to retail packages intended to be distributed to
consumers or to containers used to display bulk unpackaged and
unlabeled items at retail. The Commission also notes that, for
unpackaged, unlabeled products sold in bulk, unlabeled shrink wrap film
intended to keep a toy clean or plastic ``eggs'' designed to permit
toys to be dispensed from vending machines is not ``packaging'' which
would require labeling under the CSPA.
With respect to the other comments, the reference to the outer
container or wrapper of a product in the proposed rule tracks section
2(n) of the FHSA which requires that any labeling required under that
act shall appear on the outside container or wrapper of a hazardous
substance, unless the labeling is easily legible through the outside
container or wrapper. This provision is equally applicable to the
labeling required by the CSPA. With respect to functional components of
toys that are used to store other components, the CSPA only requires
that packaging intended for retail inspection must bear labeling. Thus,
while cardboard boxes for games may require labeling if they have a
surface that functions as a principal display panel, the Commission
believes that Congress did not intend labeling to be applied directly
to toys or components of toys that already bear labeling on their
packaging or that are not part of the retail display. However, if such
items are displayed at retail without any packaging, the items
themselves would have to bear a hang tag containing the required
labeling. The final regulation has been revised to clarify both of
these issues.

7. Definition of ``Toy or Game''

The proposed rule did not include a definition of ``toy'' or
``game.'' However, commenters requested that the Commission clarify the
scope of these terms, questioning whether arts and crafts materials,
such as paint sets or bead stringing kits, are subject to the labeling
requirements. Representatives of the Art and Creative Materials
Institute cited a decision of the United States Court of Appeals for
the Second Circuit to support the proposition that art materials are
not necessarily included in the definition of a toy. This decision,
however, addressed the issue of whether a flammable children's article
was an educational material that was exempt from the banning
requirements of the FHSA.
Past Commission actions have generally addressed the hazards
associated with articles intended for use by children, including toys
and games. The agency, therefore, has not previously undertaken to
define either term. In the absence of a regulatory definition, however,
the Commission generally looks to common dictionary definitions of
terms for guidance. For example, a toy is ``an object for children to
play with; especially something made for the amusement of a child or
for his use in play.'' A game is ``an article for use in a physical or
mental competition conducted according to rules in which the
participants play in direct opposition to each other.* * *'' (In the
Commission's view, the latter definition also includes games in which
children compete with an item itself rather than other children.) The
Commission has elected not to include definitions of the terms ``toy''
and ``game'' in the final rule, but will continue to draw upon on
common dictionary definitions of these terms for guidance in
administering the CSPA.
With respect to the specific applicability of the term ``toy'' to
arts and crafts sets intended for children three to five, these
products are primarily intended for use in play and for the amusement
of such children. The Commission therefore considers them to be
``toys.'' Such items would require labeling under the CSPA, even though
a child, in the course of play, might produce a ``functional'' item for
display or use. However, items such as pens and pencils for general use
which might incidentally be used in play would not be considered toys.
The Commission has also received inquiries concerning the status of
``hybrid'' items, such as children's toiletries which include toys or
other items subject to the CSPA. If any part of [[Page 10749]] such an
item is an article subject to the CSPA, the package of the item
requires labeling.

8. Educational Materials and Mail Order Sales

a. Sales to Educational Institutions
One commenter questioned whether packages of toys or games sold
exclusively to schools through catalogs require labeling. The primary
purpose of the CSPA is to provide a point-of-purchase warning of the
hazards that products intended for older children present to children
under three. Inasmuch as children under three are not typically present
in a traditional school setting, requiring labeling on toys and games
sold by mail solely to educational institutions such as kindergartens
and elementary schools for use exclusively in those institutions would
not accomplish the purposes of the CSPA. Accordingly, such items are
excluded from the scope of the regulation, as long as the items are
intended for children five and up. This age limitation is specified
because products intended for three and four year old children may be
sent to pre-schools or institutions such as day care centers where
children under three may be present.
b. Mail Order Sales
A few commenters questioned whether the CSPA applies to products
distributed to consumers through the mail, and, if so, whether it is
sufficient to label just the mailing wrapper or whether both the
product package and outer wrapper require labeling. Products
exclusively distributed by mail are subject to the CSPA. Since the CSPA
contemplates point-of-purchase inspection, firms can comply with the
law by conspicuously labeling either the immediate product package or
the outer wrapper. Such labeling need not be lithographed or printed on
the wrapper. The use of a stamped label will suffice. The Commission
notes that, if a product sold by mail is also sold in retail outlets,
the retail package itself must be labeled.

9. Practices Under the Small Parts Regulation

The Commission's regulations addressing the choking hazards
associated with toys and articles intended for children under three
that contain small parts establish tests to determine whether such
products will emit small parts under reasonably foreseeable conditions
of use or abuse. They also exempt from the banning provisions specific
items including writing materials (such as crayons, chalk, pencils and
pens), books and other articles made of paper, modeling clay, and
finger paints, watercolors, and other paint sets. Commenters questioned
whether these policies apply to items regulated under the CSPA.
a. Use and Abuse Testing
The proposed rule did not include a requirement for ``use and
abuse'' testing of toys and games. The rule noted that the Commission
lacked sufficient information to establish the need to apply use and
abuse tests to toys and games intended for children between three and
six years of age, or on the costs associated with imposing such
requirements. In addition, the decision not to require use and abuse
testing was based on the language of the CSPA which referred to toys or
games that ``include'' a small part.
Commenters split on the issue of applying use and abuse tests to
toys and games. Consumer advocates favored requiring such tests,
arguing that the failure to do so might mislead parents into believing
a product without labeling is safe, even though small parts might
detach from the product during play. Industry commenters, arguing
against the requirement, contended that hazard and injury data do not
support the need to impose such testing.
Given the absence of data relating to the costs of imposing such
requirements and any potential benefits, the final rule retains the
position expressed in the proposed rule and does not require use and
abuse testing. Moreover, the Commission continues to believe that a
reasonable reading of the phrase ``includes a small part'' provides a
basis for concluding that Congress did not intend to require use and
abuse testing.
The Commission notes that commenters exhibited confusion about the
applicability of use and abuse tests to solid items that are intended
to be removed or separated from toys or games during play or use, such
as accessories for action figures and battery covers that are not
screwed shut, or to items such as strip magnets that are designed to be
divided into individual components. Under the Commission's existing
policies, such items are evaluated by detaching them without applying
use and abuse testing and placing them in the test cylinder. Similarly,
if, as is discussed infra., the Commission decides that products that
are currently exempt from the small parts regulation require labeling,
items such as modeling clay and play dough, which separate into
multiple pieces of varying sizes during use, will be evaluated without
compression in the form and shape in which they are sold at retail.
b. Exempt Products
The proposed rule was silent on the applicability of the CSPA to
products that are exempt from the small parts regulation under 16 CFR
1501.3. Furthermore, there is no express reference in the CSPA or its
legislative history to the status of products that are exempt from the
small parts requirements. Commenters argued that the inclusion of
balloons, which are expressly exempt from the small parts regulation,
in the CSPA could be construed as an indication that Congress knew how
to include exempt products within the scope of the statute when it
wanted to. Since Congress only singled out balloons for coverage, other
exempt products would not require labeling. Others contended that
requiring products exempt from small parts testing to be labeled would
also create an apparent inconsistency. For example, a felt tip marker
intended for children between three and six years of age with a cap
that is a small part would require labeling (assuming, of course, that
the item is a toy), but the same item would require neither labeling
nor compliance with the small parts regulation if it were intended for
children under three.
Other commenters noted that the purpose of the exemptions to the
small parts regulation was to avoid banning functional products which
could not be produced in compliance with the small parts requirements.
These commenters argued that labeling provides a reasonable alternative
to alert parents purchasing toys and games for older children to the
potential hazards such products may present to younger children.
Furthermore, unlike the small parts performance requirements, labeling
such items would not affect their ability to be produced and sold.
In its vote on the final rule, the Commission divided on the issue
of whether toys and games that are exempt from the small parts
regulation, if they are intended for children under three, require
labeling under the CSPA, if they are intended for children three
through five years of age. Accordingly, that issue will remain
unresolved until such time as a majority of the Commission concurs on
its resolution. Pending that resolution, toys and games that are
exempted from the requirements of the small parts regulation by 16 CFR
1501.3 are not required to bear labeling under the act. However, even
if the Commission elects to require labeling for exempt products, paper
punch-out toys and games will still be exempt from the labeling
requirements, since there is [[Page 10750]] no data to indicate that
such items present a risk to children under three.

10. Bulk Sales

The CSPA requires that labeling appear not only on retail packages,
but also on bins from which unpackaged and unlabeled regulated products
are sold in bulk, containers for the retail display of such items, and
vending machines from which they are dispensed. The labels must appear
conspicuously. Administering labeling requirements of this nature is a
matter of first impression for the Commission, since the FHSA and its
regulations require an unpackaged hazardous substance to bear a label
on the item itself or on a hang tag attached to the item.
a. Obligation to Apply Labels
One commenter questioned whether retailers are required to label
store displays of items subject to the CSPA which are sold in bulk and
without packaging. The CSPA requires labeling on bins, containers for
retail display, and vending machines from which unpackaged items
subject to the act are sold or dispensed. A retailer who fails to
comply with these requirements may be subject to penalties for
violating section 4(c) of the FHSA. To assist retailers in complying
with the CSPA, the Commission suggests that manufacturers include, in
the shipping containers for bulk products, labels for the retailer to
post. For example, an 7'' x 5'' card containing the required labeling
in the type size specified by 16 CFR 1500.121 would generally suffice
to assure that large bins are conspicuously labeled. Smaller cards,
e.g. 3'' x 5'', 2'' x 4'' would generally be adequate for smaller
containers for bulk display. To provide an incentive for displaying the
cards, such cards could include an area for displaying the price of the
item. As an alternative to providing such labels, the invoice that
accompanies bulk products or the shipping container of such products
could contain a clear statement of the requirements of the law.
b. Definition of Bin or Container for Retail Display
The applicability of the CSPA to traditional dump display bins,
gold fish bowls, and similar containers that contain loose merchandise
to be inspected and selected by purchasers themselves is clear.
However, many commenters questioned whether the law applies to a
showcase or counter at which items are displayed for inspection by
purchasers but are selected by a clerk or sales person at the direction
of the purchasers. Examples include arcades in which premiums are
redeemed for coupons, carnival booths, and fast food outlets.
In the absence of any clear indication in the legislation or its
history that Congress intended to cover display cases and similar
counters, the Commission interprets the CSPA as requiring labeling only
for those bins and containers from which consumers select items
displayed in bulk. The final rule reflects this determination.

11. Small Balls and Marbles

a. Implied Upper Age Limit--Small Balls and Marbles
The CSPA requires that packages of small balls and marbles intended
for children three years of age or older, and of toys and games
containing such balls and marbles, bear precautionary labeling. The
proposed rule tracked the statutory language. Several commenters
requested that the Commission establish an upper age limit for the
purposes of labeling such products. Some suggested that an upper age
limit of eight years (96 months) would be consistent with the
provisions of 16 CFR 1500.53 which establishes use-and-abuse testing
requirements for toys intended for children in this age group. Another
comment recommended twelve or fourteen years as the upper limit, based
on the age at which children reach puberty.
Individual small balls or marbles are generally used in play by
children of all ages--that is, they are as likely to be used by five to
seven year olds as they are by nine to eleven year olds. Because there
is no distinction between the ages of the children who will use them,
all such products require labeling under the CSPA.
The Commission, however, distinguishes balls and marbles contained
in toys and games from those intended for general use. The former are
often intended for children of a specified age based on the level of
intellectual or physical development of children in that age group.
Even in the absence of precautionary labeling, the Commission believes
it highly unlikely that a parent would consider purchasing a toy or
game containing a small ball or marble intended for a child over eight
years of age for a child under three. For example, as the Commission's
age grading guidelines recognize, nine to twelve year olds have
developed sufficient fine motor coordination for labyrinth or maze
games that require maneuvering a marble along a pathway and for games
requiring careful shooting or aiming of markers. Such games, however,
would have virtually no play value for children under three. The final
rule therefore only requires labeling for toys and games containing a
small ball or marble that are intended for children under 8 years of
age. This age limit also follows the maximum age limit specified in the
Commission's regulations prescribing tests to determine whether a
children's article presents a hazard during reasonably foreseeable use
or abuse.
b. Balls for General Use in Sports
One commenter questioned whether ping pong balls and golf balls
require labeling under the CSPA, reasoning that, since children utilize
such products, the products qualify as a toy or game intended for
children under seven years of age. The commenter, however, did not
address the issue of status of these items as small balls under the
CSPA.
The Commission believes that the CSPA was not designed to cover
balls generally intended for use in sports such as golf or ping pong
which might incidentally be used by children over three. If, however,
such a ball is labeled or marketed as being intended for children or is
part of toy, game, or equipment set specifically intended for children
over three years of age but less than eight years old, the labeling
requirements apply.
c. Definition of Ball
The proposed rule defined a ``ball'' as a spheroid, ovoid, or
elliptical object that is designed or intended to be thrown, hit,
kicked, rolled, or bounced. One commenter requested that the definition
of the term ``ball'' be expanded to include items that are dropped,
commenting that some toys or games incorporate such a feature. The
Commission believes that this comment has merit and has revised the
final rule accordingly. Another commenter questioned whether tethered
balls are subject to the CSPA only if they fail use and abuse testing.
Unlike small parts which only present a hazard when they detach during
use or abuse, small balls present a choking hazard even when tethered.
Thus, tethered balls are subject to the labeling requirements,
regardless of whether they pass use or abuse tests. A third commenter
questioned how to determine whether a ball is permanently enclosed in a
maze. As discussed previously, the rule does not require use or abuse
testing to determine whether small parts are present for the purposes
of CSPA labeling. However, the final rule does reflect a limited
exception to this determination. The determination of whether a ball is
permanently enclosed in a maze or similar container [[Page 10751]] is
made by subjecting the container to the appropriate test in 16 CFR
1500.52 or 53 simulating the use and abuse of a toy or article intended
for use by children under three, in the case of banned small balls, or
three or over for labeling purposes.
d. Marbles
Since marbles are primarily intended for use by children, the
labeling requirements generally apply to all packages, games, or toys
containing marbles. Marbles that are not intended for children include
collectors' marbles and marbles for ornamental or industrial use. In
addition, the Commission has excepted from the labeling requirements
marbles that are permanently enclosed in a game or toy. As is the case
with small balls, the determination of accessibility can be made by
applying the tests of 16 CFR 1500.53.
e. Template for Testing Balls
The proposed regulation bans any ball intended for children under
three years of age that, under the influence of its own weight, passes,
in any orientation, through a circular hole with a diameter of 1.75
inches in a rigid template. One commenter questioned whether the
template must have the same dimensions as the template used to test
rattles. The pacifier regulation, 16 CFR 1511 provides a better point
of reference for testing than the rattle regulation, since the
procedure for testing pacifiers is similar to that used to test small
balls. While the final rule does not incorporate all of the external
dimensions of the pacifier test fixture, to assure that the template is
rigid, the rule indicates that the depth of the template for testing
small balls must be at least \1/4\ inch (6mm.), consistent with that of
the pacifier test fixture.

12. Balloons

The CSPA requires that the packaging of any latex balloon and any
descriptive material which accompanies such a balloon bear specific
labeling statements warning that uninflated balloons or pieces of
balloons can choke or suffocate children under eight years of age. In
the case of bulk sales of balloons, the bin, container for retail
display, or vending machine from which the balloons are sold or
dispensed must bear the required labeling statements.
a. Unpackaged Balloons Distributed Individually
One commenter expressed concern that the CSPA may require
performers, such as professional magicians, who distribute individual
unpackaged balloons to members of their audiences either to label the
individual balloons or wear a tag or sign containing the required
warnings. The law imposes neither requirement feared by the commenter.
Packages of balloons must bear precautionary labeling. However, the
bulk sale requirements of the law are designed to require labeling on
containers in which multiple products are held for retail sale. The
Commission does not believe that Congress intended these provisions to
extend to individuals who distribute unpackaged balloons that are not
held in some form of container for retail display. Thus, unpackaged
individual balloons distributed as part of a professional performance
are not subject to the requirement. The same is true for balloons used
in commercial birthday programs which are blown up prior to arrival of
the children and are used to decorate the table and party area, even
though individual balloons may be given to the children as they leave.
If, however, a performer receives packages of balloons that are
unlabeled and distributes the packages to the public, the performer
must take steps to assure that the packages are properly labeled. A
performer can comply with these requirements by purchasing packages of
balloons that are properly labeled or by placing a sticker label
containing the required labeling on unlabeled balloon packages prior to
distributing them to the public.
b. Books and Videos
The same commenter questioned the applicability of the labeling
requirements to books and videos describing balloon sculpture.
Descriptive material such as a book or videotape would only require
precautionary labeling when that material is packaged with a package of
balloons or when the material is intended to be distributed at the same
time such a package is sold or delivered to a purchaser. The fact that
a consumer who receives an instructional videotape or book may
subsequently purchase balloons does not bring the tape or book within
the ambit of the law. If an individual or company packages or
distributes to the public a package of balloons together with a
videotape, instruction sheet, or book that is classified as descriptive
material, that individual or company has the obligation to assure that
the descriptive material is properly labeled.

13. Exports

Some commenters questioned whether the CSPA requirements apply to
products manufactured in the United States exclusively for export.
Products intended for export that are labeled in accordance with the
specifications of the foreign purchaser and with the laws of the
country to which they are to be exported do not require labeling under
the CSPA, as long as the shipping container is clearly marked that the
product is for export and the product is, in fact, exported. 15 U.S.C.
1264(b)(3). However, under existing Commission policy, the manufacturer
or exporter of the product must comply with the export notification
requirements of 15 U.S.C. 1273(d) and 16 C.F.R. 1019.
14. Products Manufactured Outside the United States

The CSPA includes an alternative to labeling descriptive materials
for products manufactured outside the United States and shipped
directly to consumers. Under the alternative, if the shipping container
contains other accompanying material that is labeled conspicuously, the
descriptive material need not be labeled. One commenter requested
clarification that products packaged abroad and shipped to a U.S.
affiliate for shipment to consumers be included in the scope of this
exception. The commenter noted that the Senate Report contemplated this
type of arrangement. The Commission accepts this suggestion and has
revised the final regulation accordingly.

15. Effective Date

Several commenters requested that the Commission delay the
effective date of the final rule to permit package labels to be
redesigned and printed. Some suggested a delay of six months, while
others requested a year. However, no commenter provided a detailed
breakdown of the time frames involved.
Based on its experience with administering the prominence and
conspicuousness requirements of 16 CFR 1500.121, the Commission agrees
that a delayed effective date is appropriate. Accordingly, the final
regulation becomes effective with respect to products manufactured in
or imported into the United States six months after publication of the
final rule. However, since the effective date of the law was January 1,
1995, the labeling statements required by the act must appear on the
principal display panel of product packages in advance of publication
of the final rule. In recognition of this fact, packages with labels
lithographed or printed before the effective date of the rule may be
used for a period of up to six months after the effective date if they
display the specific statements prescribed in the statute on the
principal display panel in a manner [[Page 10752]] that is generally
conspicuous. This approach will permit packages containing labeling
that may not meet some of the more technical aspects of the rule, but
are in substantial compliance with the requirements of the law, to be
exhausted. It will also save the unnecessary expense associated with
destroying such packaging, without compromising safety.

C. 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.

D. Environmental Considerations

The proposed rule falls within the provisions of 16 C.F.R.
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.

List of Subjects in 16 CFR Part 1500

Business and industry, Consumer protection, Hazardous materials,
Infants and children, Labeling, Packaging and containers.

E. 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 amends 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 revised 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 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 (44.4
mm.) in a rigid template \1/4\ inches (6 mm.) thick. In testing to
evaluate compliance with this paragraph, the diameter of opening in the
Commission's test template shall be no greater than 1.75 inches (44.4
mm.).
(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, dropped, or bounced. The
term ``ball'' includes any spherical, ovoid, or ellipsoidal object that
is attached to 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. A
ball is permanently enclosed if, when tested in accordance with 16 CFR
1500.52, the ball is not removed from the outer container.
(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, dropped, or
bounced. The term ``ball'' includes any spherical, ovoid, or
ellipsoidal object that is attached to 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. A ball is permanently enclosed if, when tested in
accordance with 16 CFR 1500.53, it is not removed from the outer
container.
(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 (44.4 mm.) in a rigid template \1/4\
inches (6 mm.) thick. 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 (44.4 mm.).
(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, swim 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. The term ``marble'' does not
include a marble permanently enclosed in a toy or game. A marble is
permanently enclosed if, when tested in accordance with 16 CFR 1500.53,
it is not removed from the toy or game.
(5) Small part means any object which, when tested in accordance
with the procedures contained in 16 CFR [[Page 10753]] 1501.4(a) and
1501.4(b)(1), fits entirely within the cylinder shown in Figure 1
appended to 16 CFR part 1501. The use and abuse testing provisions of
16 CFR 1500.51 through 1500.53 and 1501.4(b)(2) do not apply to this
definition.
(6) Package or packaging refers to the immediate package in which a
product subject to labeling under section 24 of the act is sold, as
well as to any outer container or wrapping for that package.
(7) Descriptive material means any discrete piece of written
material separate from the label of the package that contains an
instruction (whether written or otherwise) for the use of a product
subject to these labeling requirements, any depiction of the product,
and any written material that specifically describes any function, use,
warnings, user population, design or material specification, or other
characteristic of the product. A catalog or other marketing material or
advertisement that depicts other products in addition to the product it
accompanies is not ``descriptive material'' unless it contains
additional information, such as instructions for use of the product it
accompanies or lists of accessories exclusively for use with that
product, that are designed to focus the purchaser's attention on the
product. 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. ``Descriptive material'' does not include
statements that appear on the package of a product subject to the
labeling requirements. ``Descriptive material'' does not include
material intended solely for use by children if the package it
accompanies contains a separate package insert prominently identified
as a warning for parents that contains the required precautionary
statements.
(8) Bin and container for retail display mean containers in which
multiple unpackaged and unlabeled items are held for direct selection
by and sale to consumers.
(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 and unlabeled, 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 in paragraphs (b) (1) through (4)
and paragraph (f)(3) of this section, or if such labeling statements
fail to comply with the prominence and conspicuousness requirements of
paragraph (d) of this section.
(1) With the exception of paper products such as punch-out games
and similar items, any toy or game that is intended for use by children
who are at least three years old but less than six 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 of age or
older shall bear the following cautionary statement:

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[[Page 10754]]

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(ii) Any toy or game intended for children who are at least three
years old but less than eight years of age 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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[[Page 10755]] (ii) Any toy or game intended for children who are
at least three years old but less than eight years of age 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 section 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
Sec. 1500.19(b) and (f), with the following clarifications and
modifications.
(1) All labeling statements required by Sec. 1500.19(b) and (f)
shall be in the English language. The statements required by paragraph
(b) need not appear in the format and layout depicted in paragraph (b).
The statements required by 16 CFR 1500.19(b) and (f) shall be blocked
together within a square or rectangular area, with or without a border.
This means that the statements must appear on at least two lines. The
statements shall be separated from all other graphic material by a
space no smaller than the minimum allowable height of the type size for
other cautionary material (e.g., the phrase ``Not for children under 3
yrs.''). If not separated by that distance, the labeling statements
must be surrounded by a border line. Label design, the use of
vignettes, or the proximity of other labeling or lettering shall not
obscure or render inconspicuous any labeling statement required under
Sec. 1500.19(b) and (f). This means that such statements shall appear
on a solid background, which need not differ from the background color
or any other color on the package label.
(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 this section.
(4) All other remaining statements required by this section 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. In the case of bins or containers for retail
display, the cautionary material may be placed on a display card of a
reasonable size in relationship to the surface area of the bin or
container. The area of the display card shall constitute the area of
the principal display panel. In the case of vending machines that
contain a display card, the cautionary label may be placed either on
the display card, on the coinage indicator decal, or on the glass or
clear plastic of the machine. If there is no display card inside a
vending machine, the size of the principal display panel will be
calculated in accordance with 16 CFR 1500.121(c) based on the size of
the front of the container from which items are dispensed, exclusive of
the area of metal attachments, coin inserts, bases, etc. 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, excluding any side or surface with information that only
identifies the company that owns or operates a vending machine.
(6) All of the labeling statements required by this section,
including those classified as ``other cautionary material,'' must
appear on the principal display panel of the product, except as
provided for by Sec. 1500.19(f). Any signal word shall appear on the
same line and in close proximity to the triangle required by section 24
of the act. 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 section shall comply
with the following type size requirements. 16 CFR 1500.121(c)(1)
explains how to compute the area of the principal display panel and
letter height.

Area sq. in............................................. 0-2 +2-5 +5-10 +10-15 +15-30 +30-100 +100-400 +400
Type Size.............................................. .......... .......... .......... .......... .......... .......... .......... ..........
Sig. Wd................................................. \3/64\'' \1/16\'' \3/32\'' \7/64\'' \1/8\'' \5/32\'' \1/4\'' \1/2\''
St. Haz................................................. \3/64\'' \3/64\'' \1/16\'' \3/32\'' \3/32\'' \7/64\'' \5/32\'' \1/4\''
Oth. Mat................................................ \1/32\'' \3/64\'' \1/16\'' \1/16\'' \5/64\'' \3/32\'' \7/64\'' \5/32\''

(8) Labeling required by this section 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 [[Page 10756]] 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 Sec. 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 Sec. 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 section 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 letter
of the signal word. In all other respects, triangles with exclamation
points shall conform generally to the provisions of 16 CFR 1500.121
relating to signal words.
(e) Combination of labeling statements. The labels of products that
contain more than one item subject to the requirements of this section
may combine information relating to each of the respective hazards, if
the resulting condensed statement contains all of the information
necessary to describe the hazard presented by each article. However, in
the case of a product that contains a balloon and another item subject
to the labeling requirements, only the signal word and statement of
hazard may be combined.
(f) 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 Sec. 1500.19(b)(1),
a small ball subject to Sec. 1500.19(b)(3), a marble subject to
Sec. 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 Sec. 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.
(g) Alternative for products manufactured outside the United
States. In the case of a product subject to the labeling requirements
of Sec. 1500.19(b) which is manufactured outside the United States and
is shipped directly 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
statement only if the shipping container of the product contains other
accompanying material that bears the required statements displayed in a
prominent and conspicuous manner. Products shipped from abroad to a
U.S. affiliate for shipment to consumers are included within the scope
of this exception.
(h) 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 of FHSA until January 1,
1995, if the non-identical requirement was in effect on October 2,
1993.

Dated: February 17, 1995.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.
[FR Doc. 95-4484 Filed 2-24-95; 8:45 am]
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