[Federal Register Volume 74, Number 34 (Monday, February 23, 2009)]
[Notices]
[Pages 8058-8061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3808]


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CONSUMER PRODUCT SAFETY COMMISSION


Notice of Availability of Draft Guidance Regarding Which 
Children's Products are Subject to the Requirements of CPSIA Section 
108; Request for Comments and Information

AGENCY: Consumer Product Safety Commission.

ACTION: Notice.

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SUMMARY: The Consumer Product Safety Improvement Act of 2008 (CPSIA) 
section 108 permanently prohibits the sale of any ``children's toy or 
child care article'' containing more than 0.1 percent of three 
specified phthalates. Section 108 of the CPSIA also prohibits on an 
interim basis ``toys that can be placed in a child's mouth'' or ``child 
care articles'' containing more than 0.1 percent of three additional 
phthalates. These prohibitions became effective on February 10, 2009. 
The purpose of this notice is to seek public comment on the draft 
approach prepared by CPSC staff for determining which products 
constitute a ``children's toy or child care article'' and therefore are 
subject to the requirements of section 108 of the CPSIA.\1\
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    \1\ The Commission voted unanimously (2-0) to publish the 
Federal Register Notice without change.

DATES: Comments and submissions in response to this notice must be 
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received by March 25, 2009.

ADDRESSES: Comments should be filed by e-mail to 
[email protected]. Comments also may be filed by 
telefacsimile to (301) 504-0127 or mailed, preferably in five copies, 
to the Office of the Secretary, Consumer Product Safety Commission, 
4330 East West Highway, Bethesda, Maryland 20814; telephone (301) 504-
7530. Comments should be captioned ``Notice of Availability of Draft 
Guidance Regarding Which Children's Products are Subject to the 
Requirements of CPSIA Section 108.'' Depending upon comments received 
in response to this notice, the Commission will consider issuing a 
notice of proposed rulemaking addressing these issues.

FOR FURTHER INFORMATION CONTACT: Michael A. Babich, PhD, Directorate 
for Health Sciences, U.S. Consumer Product Safety Commission, 4330 
East-West Highway, Suite 600, Bethesda, MD 20814; telephone (301) 504-
7253; e-mail [email protected].

SUPPLEMENTARY INFORMATION: 

Introduction \2\
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    \2\ This report was prepared by the CPSC staff; it has not been 
reviewed or approved, by, and may not necessarily reflect the views 
of, the Commission.
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    Section 108 of the Consumer Product Safety Improvement Act of 2008 
(CPSIA) \3\ permanently prohibits the sale of any ``children's toy or 
child care article'' containing more than 0.1 percent of three 
specified phthalates.\4\ Section 108 also prohibits on an interim basis 
``toys that can be placed in a child's mouth'' or ``child care 
articles'' containing more than 0.1 percent of three additional 
phthalates.\5\ These prohibitions became effective on February 10, 
2009.
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    \3\ Public Law 110-314.
    \4\ Di-(2-ethylhexyl)phthalate (DEHP), dibutyl phthalate (DBP), 
and benzyl butyl phthalate (BBP).
    \5\ Diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), 
and di-n-octyl phthalate (DnOP).
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    The terms ``children's toy,'' ``toy that can be placed in a child's 
mouth,'' and ``child care article'' are defined in section 108, and the 
definitions apply only to this section of the Act. The staff of the 
U.S. Consumer Product Safety Commission (CPSC) has received many 
inquiries from manufacturers seeking clarification on which products 
are subject to the requirements of section 108 and, in response, has 
developed a possible approach to guide manufacturers in determining 
which products might be subject to the requirements.
    The purpose of this notice is to seek public comment on the CPSC 
staff's draft approach for determining which products are subject to 
the requirements of section 108 of the CPSIA, and to seek additional 
information on how the approach could be applied to particular product 
classes. The examples discussed below are not comprehensive. Rather, 
they are intended to illustrate the staff's approach. Additionally, 
conclusions that are generally true for a class of products may not 
necessarily apply to each specific product in that class, for example, 
due to the way the product is advertised.
    The requirements of section 108 apply to subsets of ``consumer 
products'' as defined by the Consumer Product Safety Act (CPSA).\6\ 
Products such as food, cosmetics, and medical devices that are 
regulated by other federal agencies are generally not considered 
``consumer products.'' However, some products may fall under the 
jurisdiction of more than one agency. For example, articles such as 
infant bottles and cups are under the jurisdiction of both CPSC and the 
U.S. Food and Drug Administration (FDA). FDA has jurisdiction over 
indirect food additives, that is, when there is a possibility that a 
chemical may migrate from the article into a food or beverage. CPSC 
generally has jurisdiction over the outer portion of the product, which 
directly contacts the consumer. However, section 108 is based on 
phthalate concentration within the product and does not distinguish 
between exposure pathways. Therefore, for the purpose of CPSIA section 
108, articles such as infant bottles and cups are regarded as consumer 
products.
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    \6\ 15 U.S.C. 1261(f)(2), 1960; it should be noted, however, 
while certain products are carved out of the definition of consumer 
product, they may be regulated by the Commission under the Federal 
Hazardous Substances Act (FHSA), should they pose a health hazard 
within the meaning of that Act.
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Children's Toys

    Section 108 of the CPSIA defines a ``children's toy'' as a 
``consumer product designed or intended by the manufacturer for a child 
12 years of age or younger for use by the child when the

[[Page 8059]]

child plays.'' \7\ Any determination as to whether a particular product 
is designed or intended for use by a child 12 years of age or younger 
during play will be made after consideration of the following factors: 
\8\
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    \7\ CPSIA section 108(e)(1)(C).
    \8\ Section 108: Products Containing Certain Phthalates. http://www.cpsc.gov/about/cpsia/faq/108faq.html.
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     Whether the intended use of the product is for play, 
including a label on the product if such statement is reasonable.
     Whether the product is represented in its packaging, 
display, promotion or advertising as appropriate for use by the ages 
specified.
     Whether the product is commonly recognized by consumers as 
being intended for use by a child of the ages specified.
     The Age Determination Guidelines issued by the Commission 
staff in September 2002, and any successor to such guidelines.
    In addition, as part of the staff's proposed approach, the CPSC 
staff looked to the definition of ``toy'' in the ASTM F963-07 toy 
safety standard for guidance.\9\ The CPSIA makes ASTM F963 a mandatory 
CPSC standard on February 10, 2009. ASTM F963 excludes certain types of 
articles from the definition of toy:
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    \9\ Ibid.
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     Bicycles
     Tricycles
     Sling shots and sharp-pointed darts
     Playground equipment
     Non-powder guns
     Kites
     Art materials, model kits, and hobby items in which the 
finished product is not primarily of play value \10\
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    \10\ Art and craft materials are subject to the requirements of 
the Labeling of Hazardous Art Materials Act.
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     Sporting goods, camping goods, athletic equipment, musical 
instruments, and furniture, except for toy versions of these
     Powered models of aircraft, rockets, boats, and land 
vehicles
    The staff considered various types of balls, from generic rubber or 
plastic balls that bounce to regulation-size baseballs. Generally, 
regulation-size baseballs, basketballs, footballs, and soccer balls are 
athletic equipment and, therefore, are excluded by ASTM F963. 
Accordingly, even if they are designed or sized for use by children, 
the staff's proposed approach would exclude them from the CPSIA section 
108 requirements. In contrast, the staff has regarded general purpose 
balls as toys and therefore, subject to the requirements of the CPSIA 
section 108. A toy version of actual athletic equipment, such as a toy 
baseball glove with a foam ball would be considered by the staff to be 
a toy for the purpose of the CPSIA. A plastic bat and ball used by 
small children would also be considered by the staff to be toys. Small 
balls handed out as promotional items might be regarded as toys.
    Ordinary books, including books for small children, are generally 
not regarded as toys.\11\ However, some novelty books, such as plastic 
books marketed as bath toys, or books that incorporate sounds, may be 
regarded as toys under both ASTM F963 and CPSIA section 108.
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    \11\ General Counsel Advisory No. 323.
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    Art and craft materials and model kits generally are excluded by 
ASTM F963. These products are subject to the requirements of the 
Labeling of Hazardous Art Materials Act (LHAMA), which applies to a 
broad range of chronic hazards and requires the product formulation to 
be reviewed by a qualified toxicologist.
    Other examples of toys that might be subject to section 108 
include: bath toys, pool toys, toddler wading pools, dolls, action 
figures, costumes, masks, and balloons.

Toys That Can Be Placed in a Child's Mouth

    The CPSIA considers a toy to be a ``toy that can be placed in a 
child's mouth'' if ``any part of the toy can actually be brought to the 
mouth and kept in the mouth * * * so that it can be sucked and 
chewed.'' \12\ In addition, if any part of the toy is less than 5 cm in 
any dimension, then it can be mouthed. Thus, if the manufacturer 
determines that an article is a ``toy'' under section 108 of the CPSIA, 
then the manufacturer must determine whether the toy can be mouthed.
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    \12\ CPSIA section 108(e)(2)(B).
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    Some manufacturers have asked whether the 5 cm criterion should be 
applied to inflatable toys in the inflated or deflated state. Pool toys 
and beach balls, for example, are designed to be inflated by the 
consumer, but are commonly available to children in deflated form. 
Therefore, the staff concludes that articles such as these must be 
considered in the deflated state. However, some general purpose balls 
are permanently inflated by the manufacturer and cannot be re-inflated 
by the consumer. Therefore, these articles may be considered in the 
inflated (normal) state. Inflatable regulation-size athletic equipment, 
such as basketballs, footballs, and soccer balls excluded by ASTM F963, 
are not considered toys.

Child Care Articles

    Section 108 of the CPSIA defines a ``child care article'' as ``a 
consumer product designed or intended by the manufacturer to facilitate 
sleep or the feeding of children age 3 and younger, or to help such 
children with sucking or teething.'' \13\ While the law uses the word 
``facilitate,'' it is not defined. According to Webster's Dictionary, 
facilitate means to ``to make easier.'' As the staff began identifying 
products, it became clear that some products ``facilitate'' feeding, 
sleeping, sucking, or teething for the child directly, while other 
products ``facilitate'' those processes only indirectly, through the 
parent. The staff then considered the level of involvement or proximity 
of the child and product during the feeding, sleeping, sucking, or 
teething processes.
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    \13\ CPSIA section 108(e)(1)(C).
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    The staff proposes that products used directly in the mouth by the 
child are primary products subject to the regulation. For example, 
teethers and pacifiers go directly into the child's mouth. Products 
that have direct contact with the child, but may or may not have direct 
mouth contact, would also be considered primary products. For example, 
a bib is used during the feeding process, it helps protect the infant's 
clothing, and it has direct contact with the infant. A bib is also used 
when infants are teething to keep their clothing dry. Because of the 
close proximity to the infant's mouth and because infants explore their 
environment through mouthing, bibs can be expected to be chewed, 
sucked, and licked by infants, so they are considered primary products 
and would be subject to the regulation. Other examples of primary child 
care products might include: baby blanket, high chair, sipper cup, 
feeding bottle, and crib teething rail.
    Another class of products to be considered includes consumer 
products that are not necessarily in direct physical contact with the 
child, but are in close proximity to the child, such as cribs, crib 
mattresses, toddler mattresses, mattress covers, or mattress pads. 
These products may or may not be considered to facilitate sleep.
    Products that are used by the parent, but have no contact with the 
child, are considered secondary products and would not be subject to 
the regulation under the staff's proposal. For example, a consumer may 
use a bottle warmer to prepare the bottle to feed the infant. While the 
bottle warmer ``makes the

[[Page 8060]]

process easier'' for the adult feeding the infant, the bottle warmer 
and child have no interaction. Therefore, the staff considers the 
bottle warmer a secondary product. The staff proposes such secondary 
products to be outside the intended coverage of the law. Other examples 
of secondary child care articles might include: bottle cleaning 
products, breast pumps, nursing shield/pads, and highchair floor mats.
    Another category of child care articles includes products that have 
multiple functions. Typically, these child care articles are larger 
products that offer parents/caregivers an alternative to holding their 
child, such as bouncers, swings, and some strollers. The law states 
that if the product is ``designed or intended by the manufacturer to 
facilitate sleep or feeding'' it is subject to this ban and interim 
ban. In staff review of various baby product Web sites, manufacturers 
acknowledge that infants will sleep in bouncers, swings, and some 
strollers and consumers commonly report these products helping their 
child to fall asleep. However, facilitating sleep is not the only 
function of these products. Swings and bouncers are sold with mobiles 
and music and other features to entertain the infant. While strollers 
are promoted as comfortable transportation, some also offer reclining 
seat backs for sleeping and trays for holding food and drinks for the 
child. Other strollers are very basic with a simple upright back design 
and no other features. Clearly, newborns and young infants spend the 
majority of their time sleeping and, therefore, are likely to sleep 
anywhere. The CPSC staff considers bouncers, swings, and some strollers 
to be secondary products. However, since some manufacturers may 
advertise their products as facilitating sleep, they may be subject to 
section 108. For example, if a product such as a reclining stroller is 
intentionally designed to facilitate sleeping, then this product may be 
regarded as a ``child care article'' for the purpose of section 108 of 
the CPSIA.
    Any determination as to whether a particular product is a ``child 
care article'' as defined in section 108 of the CPSIA will be made 
after consideration of the following factors:
     Whether the intended use of the product is to facilitate 
sleeping, feeding, sucking, or teething, including a label on the 
product if such statement is reasonable.
     Whether the product is intended for use by children age 3 
or younger.
     Whether the product is a primary or secondary facilitator 
of sleeping, feeding, sucking, or teething. In other words, does it 
facilitate the process for the child directly or indirectly through the 
parent/caregiver.
     Whether the product is commonly recognized by consumers as 
being intended to facilitate sleeping, feeding, sucking, or teething.
    Some food contact products, such as infant bottles, cups, and 
eating utensils are under the jurisdiction of both CPSC and FDA. The 
staff regards these products as being subject to the requirements of 
CPSIA section 108, because they meet the definition of ``child care 
article.''
    The definition of child care article includes only sleeping, 
feeding, sucking, and teething. Thus, products associated with other 
aspects of child care, such as bathing and diapering, are not subject 
to section 108.

Request for Comment

    The Commission solicits written comments from all interested 
parties, including, but not limited to, the following topics:

I. General Approach

    A. Provide comments on staff's approach to determining which 
products are subject to the requirements of CPSIA section 108. Explain.
    a. Does it result in clear guidance? Why?
    b. Do you have suggested changes to the approach? Why?
    B. Is there an alternative approach that should be used? Please 
describe.
    C. Is there any additional guidance on products that are subject to 
section 108 that would be useful to manufacturers? Describe.
    D. What are the foreseeable consequences of the staff's approach?

II. Children's Toys and Child Care Articles

    A. Should the Commission follow the exclusions listed in ASTM F963?
    B. Some electronic devices (such as cellular phones with 
incorporated games, cameras or musical devices) are decorated or 
marketed such that they may be attractive to children 12 years old or 
younger. For example, they may be decorated with cartoon characters. 
Should these be considered toys that are subject to the phthalate 
requirements under section 108? What are the characteristics that would 
either make these products toys or not toys?
    C. Are there particular art materials, model kits, or hobby items 
that should be regarded as toys subject to section 108? Why or why not?
    D. The staff proposes that tricycles are not covered by section 
108, because they are excluded by ASTM F963. However, the staff has 
generally regarded 3- and 4-wheel ride-ons, including ``Big Wheels,'' 
as toys. What distinguishes ride-on toys from tricycles?
    E. Are there any other classes of products or specific products 
that should be excluded from the section 108 definition of toy? Why?
    F. Is the staff's approach to distinguishing between primary and 
secondary child care articles technically sound? Explain.
    G. Does the staff's approach focus on products for which there is 
the most potential for exposure to children age 3 years and under?
    H. Should cribs be considered child care articles? Should the 
entire crib be subject to the requirements or only specific parts such 
as the teething rail? Why or why not?
    I. Are there any classes of articles or particular articles that 
should be excluded from the section 108 definition of child care 
article? Why or why not?
    J. Should the following articles be regarded as subject to the 
requirements of section 108? Why or why not? Should they be classified 
as toys, child care articles, or not included?

a. Bib
b. Pajamas
c. Crib or toddler mattress
d. Mattress cover
e. Crib sheets
f. Infant sleep positioner
g. Play sand
h. Baby swing
i. Decorated swimming goggles
j. Water wings
k. Shampoo bottle in animal or cartoon character
l. Costumes and masks
m. Baby walkers
n. Wading pools

    K. Should all bouncers, swings, or strollers be subject to section 
108 or only those advertised with a manufacturer's statement that the 
intended use is to facilitate sleeping, feeding, sucking, or teething? 
How should these be classified with respect to section 108? Toys? Child 
care articles? Not covered? Explain.
    L. Should some promotional items be regarded as toys? What are the 
characteristics that would make these products toys or not toys?
    M. Should playground equipment be excluded from the definition of 
toy? Is so, what types of equipment?
    N. Should pools required to meet the standard be defined as those 
pools that do not require a filter and the addition of chemicals for 
maintenance?
    O. Please comment on our phthalates test method which can be found 
on our Web site (add link).

[[Page 8061]]

    Comments should be filed by e-mail to 
[email protected]. Comments also may be filed by 
telefacsimile to (301) 504-0127 or mailed, preferably in five copies, 
to the Office of the Secretary, Consumer Product Safety Commission, 
4330 East West Highway, Bethesda, Maryland 20814; telephone (301) 504-
7530. Comments should be captioned ``Notice of Availability of Draft 
Guidance Regarding Which Children's Products are Subject to the 
Requirements of CPSIA Section 108.'' Depending upon comments received 
in response to this notice, the Commission will consider issuing a 
notice of proposed rulemaking addressing these issues. All comments and 
submissions should be received no later than March 25, 2009.

    Dated: February 17, 2009.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. E9-3808 Filed 2-20-09; 8:45 am]
BILLING CODE 6355-01-P