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

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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