Children's Toys and Child Care Articles Containing Phthalates; Final Guidance on Inaccessible Component Parts, 10503-10507 [2013-03400]
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Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Rules and Regulations
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BILLING CODE 4910–13–P
CONSUMER PRODUCT SAFETY
COMMISSION
[Docket No. CPSC–2012–0040]
16 CFR Part 1199
Children’s Toys and Child Care
Articles Containing Phthalates; Final
Guidance on Inaccessible Component
Parts
Consumer Product Safety
Commission.
ACTION: Final rule.
AGENCY:
On August 14, 2008, Congress
enacted the Consumer Product Safety
Improvement Act of 2008 (CPSIA),
Public Law 110–314. Section 108 of the
CPSIA, as amended by Public Law 112–
28, provides that the prohibition on
specified products containing
phthalates does not apply to any
component part of children’s toys or
child care articles that is not accessible
to a child through normal and
reasonably foreseeable use and abuse of
such product. In this document, the
Consumer Product Safety Commission
(CPSC or Commission) issues guidance
on inaccessible component parts in
children’s toys or child care articles
subject to section 108 of the CPSIA.
DATES: This rule is effective February
14, 2013.
FOR FURTHER INFORMATION CONTACT:
Kristina M. Hatlelid, Ph.D., M.P.H.,
Toxicologist, Office of Hazard
Identification and Reduction, U.S.
Consumer Product Safety Commission,
5 Research Place, Rockville, MD 20850;
telephone (301) 987–2558;
khatlelid@cpsc.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
A. Background
1. Statutory Authority
On August 14, 2008, Congress enacted
the CPSIA (Pub. L. 110–314), as
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amended on August 12, 2011, by Public
Law 112–28. Section 108 of the CPSIA,
titled, ‘‘Prohibition on Sale of Certain
Products Containing Specified
Phthalates,’’ permanently prohibits the
sale of any ‘‘children’s toy or child care
article’’ containing more than 0.1
percent of three specified phthalates (di(2-ethylhexyl) phthalate (DEHP), dibutyl
phthalate (DBP), and benzyl butyl
phthalate (BBP)). Section 108 of the
CPSIA also prohibits, on an interim
basis, ‘‘toys that can be placed in a
child’s mouth’’ or ‘‘child care article’’
containing more than 0.1 percent of
three additional phthalates (diisononyl
phthalate (DINP), diisodecyl phthalate
(DIDP), and di-n-octyl phthalate
(DnOP)). These prohibitions became
effective on February 10, 2009. 15
U.S.C. 2057c(a), (b). The terms or
phrases ‘‘children’s toy,’’ ‘‘toy that can
be placed in a child’s mouth,’’ and
‘‘child care article,’’ are defined in
section 108(g) of the CPSIA. A
‘‘children’s toy’’ is defined 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 child plays.’’ A toy 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 by a child
so that it can be sucked and chewed. If
the children’s product can only be
licked, it is not regarded as able to be
placed in the mouth. If a toy or part of
a toy in one dimension is smaller than
5 centimeters, it can be placed in a
child’s mouth.’’ The term ‘‘child care
article’’ means ‘‘a consumer product
designed or intended by the
manufacturer to facilitate sleep or the
feeding of children age 3 years and
younger, or to help such children with
sucking or teething.’’ 15 U.S.C. 2057c(g).
Section 108(d) of the CPSIA provides
that the prohibitions for the specified
phthalates shall not apply to any
component part of a children’s toy or
child care article that is not accessible
to a child through normal and
reasonably foreseeable use and abuse of
such product, as determined by the
Commission. That section further
provides that a component part is not
accessible, if such component part is not
physically exposed, by reason of a
sealed covering or casing, and does not
become physically exposed through
reasonably foreseeable use and abuse of
the product. Reasonably foreseeable use
and abuse includes swallowing,
mouthing, breaking, or other children’s
activities, and the aging of the product.
15 U.S.C. 2057c(d)(1).
The CPSIA directs the Commission to:
(A) Promulgate a rule providing
guidance with respect to what product
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components, or classes of components,
will be considered to be inaccessible; or
(B) adopt the same guidance with
respect to inaccessibility that was
adopted by the Commission with regard
to accessibility of lead under section
101(b)(2)(B) (15 U.S.C. 1278a(b)(2)(B)),
with additional consideration, as
appropriate, of whether such
component can be placed in a child’s
mouth. 15 U.S.C. 2057c(d)(3).
Section 108 of the CPSIA also
directed the Commission, not earlier
than 180 days after the date of
enactment of this Act [enacted Aug. 14,
2008], to appoint a Chronic Hazard
Advisory Panel (CHAP), pursuant to the
procedures of section 28 of the CPSA
(15 U.S.C. 2077), to study the effects on
children’s health of all phthalates and
phthalate alternatives as used in
children’s toys and child care articles.
15 U.S.C. 2057c(b)(2). The Commission
appointed the CHAP on April 14, 2010,
to study the effects on children’s health
of all phthalates and phthalate
alternatives, as used in children’s toys
and child care articles. The CHAP
currently is working on a report,
including recommendations, to be sent
to the Commission.
Under section 108(d)(2) of the CPSIA,
the Commission may revoke any or all
exclusions granted based on the
inaccessible component parts provision
of section 108 of the CPSIA, at any time,
and require that any or all component
parts manufactured after such exclusion
is revoked, comply with the
prohibitions of phthalates, if the
Commission finds, based on scientific
evidence, that such compliance is
necessary to protect the public health or
safety. 15 U.S.C. 2057c(d)(2).
2. Notice of Proposed Guidance
In the Federal Register notice of July
31, 2012 (77 FR 45297), the Commission
published a proposed guidance on
inaccessible phthalate-containing
component parts. As stated in the
preamble to the proposed guidance (77
FR 45299), the Commission proposed to
adopt the lead guidance for determining
inaccessible component parts for
phthalates, with the exception of
polyvinyl chloride (PVC or vinyl) or
other plasticized materials covering
mattresses and other sleep surfaces
designed or intended by the
manufacturer to facilitate sleep of
children age 3 and younger. Both the
lead guidance and proposed phthalate
guidance specified that a children’s
product, toy, or child care article that is
completely enclosed or covered by
fabric is considered inaccessible to a
child, unless the product or part of the
product in one dimension is smaller
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than 5 centimenters. However, the lead
guidance did not exclude vinyl or other
plasticized materials covering
mattresses and other sleep surfaces. The
proposed phthalate guidance found that
while lead is unlikely to leach through
fabric except in the case of mouthing or
swallowing an item, sheets or mattress
pads that cover a vinyl sleep or other
plasticized sleep surface should not
serve as a barrier to the potential
exposure of phthalates for young
children. A child’s skin comes into
close contact with mattresses and
similar products for large portions of a
day, and a mattress cover could be
dampened with a spilled beverage,
saliva, sweat, urine, or other liquid,
which could facilitate phthalate
migration through a fabric covering. 74
FR 39539 (August 7, 2009).
In addition, although section 108 did
not specifically disqualify paint,
coatings, or electroplating as barriers
that would render phthalates
inaccessible, the Commission proposed
to adopt the same guidance with respect
to inaccessibility for phthalates that was
adopted by the Commission with regard
to inaccessibility of lead. The proposed
phthalates guidance stated that paint,
coatings, and electroplating may not be
considered a barrier that would render
phthalate-containing component parts
of toys and child care articles
inaccessible. The proposed phthalates
guidance also noted that in some
applications, phthalates are added to
paint, printing inks, or coatings. 77
FR45299.
In addition, the Commission
determined preliminarily that:
• An accessible component part is
one that is capable of being touched or
mouthed by a child;
• An inaccessible component part is
one that is located inside the product
and not capable of being touched or
mouthed by a child, whether or not
such part is visible to a user of the
product;
• An inaccessible part is one that may
be enclosed in any type of material, e.g.,
hard or soft plastic, rubber, or metal
(with the exception of vinyl or other
plasticized materials covering
mattresses or other sleep surfaces for
children age 3 and younger);
• To assess whether a part is
inaccessible, the accessibility probes
defined in the Commission’s existing
regulations for evaluating accessibility
of sharp points or sharp metal or glass
edges (16 CFR 1500.48 and 1500.49) are
appropriate. An ‘‘accessible phthalatecontaining component part’’ would be
considered one that contacts any
portion of the specified segment of the
accessibility probe. An ‘‘inaccessible
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phthalate-containing component part’’
would be considered as one that cannot
be contacted by any portion of the
specified segment of the accessibility
probe; and
• Use and abuse tests are appropriate
for evaluating whether phthalatecontaining component parts of a
product become accessible to a child
during normal and reasonably
foreseeable use and abuse of the product
by a child (with the exception of the bite
test). The purpose of the tests is to
simulate use and damage or abuse of a
product by children and to expose
potential hazards that might result from
use and abuse. 16 CFR 1500.50–1500.53.
B. Discussion of Comments to the
Proposed Guidance and CPSC’s
Responses
Five comments were received on the
proposed guidance. Two of the
comments were from industry and three
from consumers or nonprofit consumer
and public health organizations. Most
comments express general support for
the guidance.
1. Fabric Materials as a Barrier to
Accessibility of Component Parts
Comment: One commenter states that
fabric should not be considered a
barrier, regardless of the size of the
component, because children could be
exposed to phthalates through the
fabric.
Response: As provided in CPSC staff’s
briefing memo ‘‘Guidance for Evaluating
Accessibility of Phthalate-Containing
Component Parts’’ dated July 13, 2012,
CPSC staff is not aware of any studies
that show the propensity for phthalates
to move from a phthalate-containing
material through an intact, nonphthalate-containing material, such as
an outside covering, where it could
eventually reach the outside of a
product. Furthermore, CPSC staff’s
review showed that the non-vapor
passive movement of phthalates within
a product, if it exists, would be
exceedingly slow and would never
account for any more than a small,
negligible fraction of the original
phthalate content of the inaccessible
phthalate-containing part. Based on
CPSC staff’s analysis, the Commission
finds that, in most cases, phthalates that
are inaccessible would not result in
physical exposure to phthalates, unless
it is reasonably foreseeable that a
component part will become physically
exposed through mouthing, swallowing,
breaking, or other children’s activities,
and aging of the product. Accordingly,
a children’s toy or child care article that
is, or contains, a phthalate-containing
part that is enclosed, encased, or
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covered by fabric and passes the
appropriate use and abuse tests on such
covers, is considered inaccessible to a
child, unless the product, or part of the
product, in one dimension, is smaller
than 5 centimeters; i.e., a fabric-covered
component part is not inaccessible if the
product, or part of the product, can be
placed in a child’s mouth.
Moreover, the Commission reiterates
that vinyl or other plasticized materials
covering mattresses and other sleep
surfaces designed or intended by a
manufacturer to facilitate sleep for
children age 3 and younger should not
be considered to be made inaccessible
through the use of a fabric covering. As
discussed in the preamble of the
proposed guidance, the Commission
reviewed phthalate-containing vinyl or
other plasticized materials covering
mattresses and sleep surfaces intended
for young children. These mattresses or
sleep surfaces are too large to be placed
in a child’s mouth. Although such
mattresses or sleep surfaces may be
covered by fabric, such as sheets or
mattress pads, additional consideration
was given to whether children would
become physically exposed to the vinyl
or other plasticized materials covering
the surface through reasonably
foreseeable use and abuse of the
products, including swallowing,
mouthing, breaking, or other children’s
activities, and the aging of the product.
The Commission determined there may
be instances in which a child’s skin
comes into close contact with a fabric
covering over a phthalate-containing
item for large portions of a day, such as
a vinyl or other plasticized material
covering a mattress or other sleep
surface. Young children typically spend
more than half of each day sleeping or
resting, frequently on a mattress or
similar item. While a mattress is
typically covered with a sheet or
mattress pad, such non-permanently
affixed coverings that are either
supplied with the mattress or provided
by the consumer should not be
considered to render the underlying
material inaccessible. As with the
potential transfer of phthalates by saliva
during mouthing of an item, a mattress
cover dampened with a spilled
beverage, saliva, sweat, urine, or other
liquid, could facilitate phthalate
migration through the fabric.
Furthermore, a nonpermanent covering
cannot be assumed to be in use at all
times; if it is not, the mattress could no
longer be considered inaccessible. For
these reasons, vinyl (or other plasticized
material) covered mattresses/sleep
surfaces, which contain phthalates,
designed or intended by a manufacturer
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to facilitate sleep for children age 3 and
younger, should not be considered to be
made inaccessible through the use of a
fabric covering.
Comment: One commenter states that
the proposed guidance ‘‘exempts
components covered in fabric provided
that the underlying component is not
smaller than 5 centimeters in any one
dimension.’’ According to the
commenter, any exposure to phthalatescontaining component parts within
fabric coverings is very low and all
phthalate-containing components parts
covered by fabric should be exempt,
irrespective of the size of the part. The
commenter also suggests that a de
minimis exception should be considered
for accessible small plasticized parts.
Response: The commenter
misinterprets the fabric covering
restriction in the proposed guidance on
inaccessible phthalate-containing
component parts. The proposed
guidance states that ‘‘a children’s
product that is or contains a phthalatecontaining part which is enclosed,
encased, or covered by fabric and passes
the appropriate use and abuse tests on
such covers, is inaccessible to a child
unless the product or part of the product
in one dimension is smaller than 5
centimeters.’’ However, the 5 centimeter
measure is applied to the fabric-covered
part or product (i.e., a fabric covered
plastic button), not to the size of the
underlying phthalate-containing
component part. If a toy or part of a toy
in one dimension is smaller than 5
centimeters, it can be placed in a child’s
mouth (i.e., a fabric covered plastic ear
on a stuffed animal). A phthalatecontaining component part which is
encased by a fabric covering is
considered to be accessible to a child if
the part or product is smaller than 5
centimeters in any dimension because
such a part or product could be placed
in a child’s mouth, and the fabric is not
expected to perform as a barrier to saliva
or other fluids or to prevent direct
contact by the child with the saliva or
other fluid after a fluid’s contact with
the phthalate-containing part. Even if a
fabric covering passes the applicable use
and abuse tests, such a covering is not
a barrier to the underlying material if
the product can be placed in the mouth
because it is smaller than 5 centimeters.
If the phthalate-containing component
part that is encased by fabric covering
is 5 centimeters or greater in dimension,
such a part of product is considered to
be inaccessible to a child, because the
part or product in not likely to be put
in the mouth or swallowed (i.e., plastic
electronic box inside a stuffed animal).
As discussed above, however, vinyl or
other plasticized material covering a
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mattress or other sleep surface which is
designed or intended by a manufacturer
to facilitate sleep of children age 3 and
younger, even when covered with a
sheet or mattress pad, will still be
considered accessible given that the
foreseeable use and abuse of the
product, including spilled beverages,
saliva, sweat, urine, or other liquids,
may facilitate phthalate migration
through the fabric.
The statute does not provide for a de
minimis exception for accessible
component parts, and the Commission
is not considering in this guidance such
exceptions for accessible phthalatecontaining children’s toys and child
care articles. However, we note that a
CHAP has been convened to study the
effects on children’s health of all
phthalates and phthalate alternatives, as
used in children’s toys and child care
articles. Based on the findings and
recommendations of the CHAP, any
guidance concerning phthalates may be
modified and revised, as appropriate.
Comment: The same commenter also
states that the exclusion of fabric
materials as a barrier to accessibility for
phthalate-containing parts or products
smaller than 5 centimeters is
inconsistent with the Commission’s use
and abuse testing.
Response: The proposed guidance
provides that accessibility of component
parts, as a result of normal and
reasonably foreseeable use and abuse of
the product, should be evaluated using
the use and abuse tests under the
Commission’s regulations at 16 CFR
1500.50 through 1500.53 (excluding the
bite test in paragraph (c) of §§ 1500.51–
1500.53). We disagree that the exclusion
of fabric materials as a barrier to
accessibility is inconsistent with the
Commission’s use and abuse testing.
The Commission finds, in general, that
fabric coverings can be considered
barriers to the underlying materials
because such coverings prevent direct
physical contact with the phthalatecontaining parts. The appropriate use
and abuse tests, such as the test for the
integrity of seams, should be used to
evaluate fabric coverings to ensure that
the component parts remain physically
inaccessible to a child. Use and abuse
testing generally is applied to evaluate
whether a component part may become
physically accessible as a result of
reasonably foreseeable use and abuse of
the product, including swallowing,
mouthing, breaking, or other children’s
activities. Historically, this testing has
been used to evaluate the presence of
physical hazards, such as small parts,
which may be choking hazards, or sharp
points and edges. In the case of leadcontaining or phthalate-containing
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component parts, these tests are used to
evaluate the potential for physical
contact with the parts. The material
beneath a fabric covering should not be
considered to be inaccessible to a child
if the part or product is smaller than 5
centimeters in any dimension because
such a part or product could be placed
in a child’s mouth, and fabric is not
expected to perform as a barrier to saliva
or other fluids or to prevent direct
contact by the child with the saliva or
other fluid after a fluid’s contact with
the phthalate-containing part. Even if a
fabric covering passes the applicable use
and abuse tests, such a covering is not
a barrier to the underlying material if
the product can be placed in the mouth.
2. Exclusion of the ‘‘Bite Test’’ from Use
and Abuse Testing
Comment: Two commenters question
the exclusion of the ‘‘bite test’’ from the
use and abuse testing and requested that
it be included in the guidance.
Response: Currently, the Commission
does not use the bite test specified in 16
CFR 1500.51–1500.53), as a result of a
court case (Clever Idea Co., Inc. v.
Consumer Product Safety Commission,
385 F. Supp. 688 (E.D. N.Y. 1974)) that
questioned the appropriateness of this
test. Because the bite test currently is
not applied as part of use and abuse
testing for consumer products, it will
not be applied for the purposes of
evaluating products for accessibility of
phthalate-containing component parts.
However, this requirement may be
modified in a future proceeding if the
bite test is reevaluated.
3. Requirements for Labeling of Art
Materials
Comment: One commenter requests
consistency among the requirements for
paints and other surface coatings for
lead and phthalates and the
requirements under ASTM D 4236 and
ASTM F 963 that address art materials.
This commenter specifically requests
that bottles of paint available in retail
stores should comply with all
requirements because such paint could
be used by children or on products for
children.
Response: This comment is outside
the scope of this guidance, which
addresses the issue of when a phthalatecontaining component part of a
children’s toy or child care article is
considered to be inaccessible to a child.
The Standard Consumer Safety
Specification for Toy Safety, ASTM F
963 requires that all art materials
comply with the Labeling of Hazardous
Art Materials Act (LHAMA). In addition
to the LHAMA requirements discussed
above, art materials that are designed or
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intended primarily for children 12 years
of age or younger, are also required, like
all children’s products, to comply with
the requirements of the CPSIA,
including third party testing and
certification.
C. Effective Date
Although guidance documents do not
require a particular effective date under
the Administrative Procedure Act, 5
U.S.C. 553(d)(2), the Commission
recognizes the need for providing the
guidance expeditiously. In addition,
material published in the Code of
Federal Regulations must have an
effective date. Accordingly, the
guidance will take effect upon
publication in the Federal Register.
D. Final Guidance
The Commission is issuing the final
guidance without substantive change
from the proposed guidance.
List of Subjects in 16 CFR Part 1199
Business and industry, Infants and
children, Consumer protection, Imports,
Toys.
For the reasons stated above, the
Commission adds 16 CFR part 1199 to
read as follows:
PART 1199— CHILDREN’S TOYS AND
CHILD CARE ARTICLES CONTAINING
PHTHALATES: GUIDANCE ON
INACCESSIBLE COMPONENT PARTS
Authority: 15 U.S.C. 1251–1289, 86 Stat.
1207, 125 Stat. 273.
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§ 1199.1 Children’s toys and child care
articles: Phthalate-containing inaccessible
component parts.
(a) Section 108 of the Consumer
Product Safety Improvement Act of
2008 (CPSIA) permanently prohibits the
sale of any ‘‘children’s toy or child care
article’’ containing more than 0.1
percent of three specified phthalates (di(2-ethylhexyl) phthalate (DEHP), dibutyl
phthalate (DBP), and benzyl butyl
phthalate (BBP)). Section 108 of the
CPSIA also prohibits, on an interim
basis, ‘‘toys that can be placed in a
child’s mouth’’ or ‘‘child care article’’
containing more than 0.1 percent of
three additional phthalates (diisononyl
phthalate (DINP), diisodecyl phthalate
(DIDP), and di-n-octyl phthalate
(DnOP)). A ‘‘children’s toy’’ is defined
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 child plays. A toy 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 by a child
so that it can be sucked and chewed. If
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the children’s product can only be
licked, it is not regarded as able to be
placed in the mouth. If a toy or part of
a toy in one dimension is smaller than
5 centimeters, it can be placed in the
mouth. The term ‘‘child care article’’
means a consumer product designed or
intended by the manufacturer to
facilitate sleep or the feeding of children
age 3 years and younger, or to help such
children with sucking or teething.
(b) Section 108(d) of the CPSIA
provides that the prohibitions in
paragraph (a) of this section do not
apply to component parts of a children’s
toy or child care article that are not
accessible to children through normal
and reasonably foreseeable use and
abuse of such product, as determined by
the Commission. A component part is
not accessible if it is not physically
exposed, by reason of a sealed covering
or casing, and does not become
physically exposed through reasonably
foreseeable use and abuse of the
product, including swallowing,
mouthing, breaking, or other children’s
activities, and the aging of the product.
(c) Section 108(d)(3) of the CPSIA
directs the Commission to promulgate a
rule to provide guidance with respect to
what product components or classes of
components will be considered to be
inaccessible for a children’s toy or child
care article that contains phthalates or
adopt the same guidance with respect to
inaccessibility that was adopted by the
Commission with regard to accessibility
of lead under section 101(b)(2)(B) (15
U.S.C. 1278a(b)(2)(B)), with additional
consideration, as appropriate, of
whether such component can be placed
in a child’s mouth. 15 U.S.C.
2057c(d)(3). The Commission adopts the
same guidance with respect to
inaccessibility for the phthalates that
was adopted by the Commission with
regard to accessibility of lead, however,
vinyl (or other plasticized material)
covered mattresses/sleep surfaces, that
contain phthalates that are designed or
intended by the manufacturer to
facilitate sleep of children age 3 and
younger, are considered accessible and
would not be considered inaccessible
through the use of fabric coverings,
including sheets and mattress pads.
(d) The accessibility probes specified
for sharp points or edges under the
Commission’s regulations at 16 CFR
1500.48–1500.49 should be used to
assess the accessibility of phthalatecontaining component parts of a
children’s toy or child care article. A
phthalate-containing component part
would be considered accessible if it can
be contacted by any portion of the
specified segment of the accessibility
probe. A phthalate-containing
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component part would be considered
inaccessible if it cannot be contacted by
any portion of the specified segment of
the accessibility probe.
(e) For children’s toys or child care
articles intended for children that are 18
months of age or younger, the use and
abuse tests set forth under the
Commission’s regulations at 16 CFR
1500.50 and 16 CFR 1500.51 (excluding
the bite test of § 1500.51(c)), should be
used to evaluate accessibility of
phthalate-containing component parts
of a children’s toy or child care article
as a result of normal and reasonably
foreseeable use and abuse of the
product.
(f) For children’s toys or child care
articles intended for children that are
over 18 months, but not over 36 months
of age, the use and abuse tests set forth
under the Commission’s regulations at
16 CFR 1500.50 and 16 CFR 1500.52
(excluding the bite test of § 1500.52(c)),
should be used to evaluate accessibility
of phthalate-containing component
parts of a children’s toy or child care
article as a result of normal and
reasonably foreseeable use and abuse of
the product.
(g) For children’s toys intended for
children that are over 36 months, but
not over 96 months of age, the use and
abuse tests set forth under the
Commission’s regulations at 16 CFR
1500.50 and 16 CFR 1500.53 (excluding
the bite test of § 1500.53(c)), should be
used to evaluate accessibility of
phthalate-containing component parts
of a children’s toy as a result of normal
and reasonably foreseeable use and
abuse of the product.
(h) For children’s toys intended for
children over 96 months through 12
years of age, the use and abuse tests set
forth under the Commission’s
regulations at 16 CFR 1500.50 and 16
CFR 1500.53 (excluding the bite test of
§ 1500.53(c)) intended for children ages
37–96 months should be used to
evaluate accessibility of phthalatecontaining component parts of a
children’s toy as a result of normal and
reasonably foreseeable use and abuse of
the product.
(i) Because the Commission adopts
the same guidance with respect to
inaccessibility for phthalates that was
adopted by the Commission with regard
to inaccessibility of lead, paint,
coatings, and electroplating may not be
considered a barrier that would render
phthalate-containing component parts
of toys and child care articles
inaccessible. A children’s toy or child
care article that is or contains a
phthalate-containing part that is
enclosed, encased, or covered by fabric
and passes the appropriate use and
E:\FR\FM\14FER1.SGM
14FER1
Federal Register / Vol. 78, No. 31 / Thursday, February 14, 2013 / Rules and Regulations
abuse tests on such covers, is
considered inaccessible to a child,
unless the product or part of the
product, in one dimension, is smaller
than 5 centimeters. However, vinyl (or
other plasticized material) covered
mattresses/sleep surfaces that contain
phthalates that are designed or intended
by the manufacturer to facilitate sleep of
children age 3 and younger, are
considered accessible and would not be
considered inaccessible through the use
of fabric coverings, including sheets and
mattress pads.
(j) The intentional disassembly or
destruction of products by children
older than age 8 years, by means or
knowledge not generally available to
younger children, including use of tools,
will not be considered in evaluating
products for accessibility of phthalatecontaining components.
Dated: February 11, 2013.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2013–03400 Filed 2–13–13; 8:45 am]
BILLING CODE 6335–01–P
DEPARTMENT OF THE INTERIOR
Office of Surface Mining Reclamation
and Enforcement
30 CFR Part 926
Montana Regulatory Program
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Final rule.
AGENCY:
We are issuing a final
decision on an amendment to the
Montana regulatory program (the
Montana program) under the Surface
Mining Control and Reclamation Act of
1977 (SMCRA or the Act). We are not
approving the amendment. Montana
proposes changes to the Montana Strip
and Underground Mine Reclamation
Act (MSUMRA) that differentiate
between coal beneficiation and coal
preparation plants. Montana revised its
program to clarify ambiguities and
improve operational efficiency.
DATES: Effective Date: February 14,
2013.
mstockstill on DSK4VPTVN1PROD with RULES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Jeffrey Fleischman, Casper Field Office
Director, Telephone: (307) 261–6550,
Internet address:
jfleischman@OSMRE.gov.
VerDate Mar<15>2010
16:39 Feb 13, 2013
Jkt 229001
I. Background on the Montana Program
Section 503(a) of the Act permits a
State to assume primacy for the
regulation of surface coal mining and
reclamation operations on non-Federal
and non-Indian lands within its borders
by demonstrating that its State program
includes, among other things, ‘‘a State
law which provides for the regulation of
surface coal mining and reclamation
operations in accordance with the
requirements of this Act * * *; and
rules and regulations consistent with
regulations issued by the Secretary
pursuant to this Act.’’ See 30 U.S.C.
1253(a)(1) and (7). On the basis of these
criteria, the Secretary of the Interior
conditionally approved the Montana
program on April 1, 1980. You can find
background information on the Montana
program, including the Secretary’s
findings, the disposition of comments,
and conditions of approval in the April
1, 1980, Federal Register (45 FR 21560).
You can also find later actions
concerning Montana’s program and
program amendments at 30 CFR 926.15,
926.16, and 926.30.
II. Submission of the Proposed
Amendment
[SATS No. MT–032–FOR; Docket ID No.
OSM–2011–0011]
SUPPLEMENTARY INFORMATION:
I. Background on the Montana Program
II. Submission of the Proposed Amendment
III. Office of Surface Mining Reclamation and
Enforcement’s (OSMRE’s) Findings
IV. Summary and Disposition of Comments
V. OSMRE’s Decision
VI. Procedural Determinations
By letter dated June 7, 2011, Montana
sent us a proposed amendment to its
program (SATS number: MT–032–FOR,
Administrative Record Docket ID No.
OSM–2011–0011) under SMCRA (30
U.S.C. 1201 et seq.). Montana submitted
the amendment to include changes
made to the MSUMRA as a result of the
Montana Legislature’s 2011 passage of a
Senate Bill (SB 297) relating to coal
beneficiation. Montana sent the
amendment to include changes made at
its own initiative.
We announced receipt of the
proposed amendment in the October 17,
2011, Federal Register (76 FR 64045). In
the same document, we opened the
public comment period and provided an
opportunity for a public hearing or
meeting on the amendment’s adequacy
(Administrative Record No. MT–29–11;
Administrative Record Document ID No.
OSM–2011–0011–0001). We did not
hold a public hearing or meeting
because no one requested one. The
public comment period ended on
November 16, 2011. We received four
public comments and four Federal
agency comments (discussed under ‘‘IV.
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
10507
Summary and Disposition of
Comments’’).
During our review of Montana’s
submittal and the comments received,
we identified concerns with the
amendment proposal including its
newly proposed statutory definition of
‘‘Coal beneficiation plant’’ at Montana
Code Annotated (MCA) Section 82–4–
203(9), as well as proposed revisions to
its currently approved statutory
definitions of ‘‘Coal preparation plant’’
at MCA Section 82–4–203(11);
‘‘Operation’’ at MCA Section 82–4–
203(34); ‘‘Operator’’ at MCA Section 82–
4–203(35); ‘‘Strip mining’’ at MCA
Section 82–4–203(48) (b); and
‘‘Underground mining’’ at MCA Section
82–4–203(52). We notified Montana of
these concerns by letter dated February
14, 2012 (Administrative Record No.
MT–29–15; Administrative Record
Document ID No. OSM–2011–0011–
0011).
We delayed final rulemaking to afford
Montana the opportunity to submit new
material to address the deficiencies.
Montana responded in a letter dated
March 14, 2012, that all of the proposed
changes are legislative amendments to
the MSUMRA and because they are
changes in statute and not rule, the
Montana Department of Environmental
Quality (DEQ) has no authority to
amend them (Administrative Record No.
MT–29–16; Administrative Record
Document ID No. OSM–2011–0011–
0012). As a result, Montana stated that
it will not be submitting revised
amendments or draft proposed changes
in response to our February 14, 2012,
letter. Therefore, we are proceeding
with the final rule Federal Register
document.
III. OSMRE’s Findings
30 CFR 732.17(h)(10) requires that
State program amendments meet the
criteria for approval of State programs
set forth in 30 CFR 732.15, including
that the State’s laws and regulations are
in accordance with the provisions of the
Act and consistent with the
requirements of 30 CFR Part 700. In 30
CFR 730.5, OSMRE defines ‘‘consistent
with’’ and ‘‘in accordance with’’ to
mean (a) with regard to SMCRA, the
State laws and regulations are no less
stringent than, meet the minimum
requirements of, and include all
applicable provisions of the Act and (b)
with regard to the Federal regulations,
the State laws and regulations are no
less effective than the Federal
regulations in meeting the requirements
of SMCRA.
Following are the findings we made
concerning the amendment under
SMCRA and the Federal regulations at
E:\FR\FM\14FER1.SGM
14FER1
]]>Agencies
[Federal Register Volume 78, Number 31 (Thursday, February 14, 2013)]
[Rules and Regulations]
[Pages 10503-10507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03400]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
[Docket No. CPSC-2012-0040]
16 CFR Part 1199
Children's Toys and Child Care Articles Containing Phthalates;
Final Guidance on Inaccessible Component Parts
AGENCY: Consumer Product Safety Commission.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: On August 14, 2008, Congress enacted the Consumer Product
Safety Improvement Act of 2008 (CPSIA), Public Law 110-314. Section 108
of the CPSIA, as amended by Public Law 112-28, provides that the
prohibition on specified products containing phthalates does not apply
to any component part of children's toys or child care articles that is
not accessible to a child through normal and reasonably foreseeable use
and abuse of such product. In this document, the Consumer Product
Safety Commission (CPSC or Commission) issues guidance on inaccessible
component parts in children's toys or child care articles subject to
section 108 of the CPSIA.
DATES: This rule is effective February 14, 2013.
FOR FURTHER INFORMATION CONTACT: Kristina M. Hatlelid, Ph.D., M.P.H.,
Toxicologist, Office of Hazard Identification and Reduction, U.S.
Consumer Product Safety Commission, 5 Research Place, Rockville, MD
20850; telephone (301) 987-2558; khatlelid@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
1. Statutory Authority
On August 14, 2008, Congress enacted the CPSIA (Pub. L. 110-314),
as amended on August 12, 2011, by Public Law 112-28. Section 108 of the
CPSIA, titled, ``Prohibition on Sale of Certain Products Containing
Specified Phthalates,'' permanently prohibits the sale of any
``children's toy or child care article'' containing more than 0.1
percent of three specified phthalates (di-(2-ethylhexyl) phthalate
(DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP)).
Section 108 of the CPSIA also prohibits, on an interim basis, ``toys
that can be placed in a child's mouth'' or ``child care article''
containing more than 0.1 percent of three additional phthalates
(diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-n-
octyl phthalate (DnOP)). These prohibitions became effective on
February 10, 2009. 15 U.S.C. 2057c(a), (b). The terms or phrases
``children's toy,'' ``toy that can be placed in a child's mouth,'' and
``child care article,'' are defined in section 108(g) of the CPSIA. A
``children's toy'' is defined 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 child plays.'' A toy 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 by a child so that it can be sucked and
chewed. If the children's product can only be licked, it is not
regarded as able to be placed in the mouth. If a toy or part of a toy
in one dimension is smaller than 5 centimeters, it can be placed in a
child's mouth.'' The term ``child care article'' means ``a consumer
product designed or intended by the manufacturer to facilitate sleep or
the feeding of children age 3 years and younger, or to help such
children with sucking or teething.'' 15 U.S.C. 2057c(g).
Section 108(d) of the CPSIA provides that the prohibitions for the
specified phthalates shall not apply to any component part of a
children's toy or child care article that is not accessible to a child
through normal and reasonably foreseeable use and abuse of such
product, as determined by the Commission. That section further provides
that a component part is not accessible, if such component part is not
physically exposed, by reason of a sealed covering or casing, and does
not become physically exposed through reasonably foreseeable use and
abuse of the product. Reasonably foreseeable use and abuse includes
swallowing, mouthing, breaking, or other children's activities, and the
aging of the product. 15 U.S.C. 2057c(d)(1).
The CPSIA directs the Commission to: (A) Promulgate a rule
providing guidance with respect to what product components, or classes
of components, will be considered to be inaccessible; or (B) adopt the
same guidance with respect to inaccessibility that was adopted by the
Commission with regard to accessibility of lead under section
101(b)(2)(B) (15 U.S.C. 1278a(b)(2)(B)), with additional consideration,
as appropriate, of whether such component can be placed in a child's
mouth. 15 U.S.C. 2057c(d)(3).
Section 108 of the CPSIA also directed the Commission, not earlier
than 180 days after the date of enactment of this Act [enacted Aug. 14,
2008], to appoint a Chronic Hazard Advisory Panel (CHAP), pursuant to
the procedures of section 28 of the CPSA (15 U.S.C. 2077), to study the
effects on children's health of all phthalates and phthalate
alternatives as used in children's toys and child care articles. 15
U.S.C. 2057c(b)(2). The Commission appointed the CHAP on April 14,
2010, to study the effects on children's health of all phthalates and
phthalate alternatives, as used in children's toys and child care
articles. The CHAP currently is working on a report, including
recommendations, to be sent to the Commission.
Under section 108(d)(2) of the CPSIA, the Commission may revoke any
or all exclusions granted based on the inaccessible component parts
provision of section 108 of the CPSIA, at any time, and require that
any or all component parts manufactured after such exclusion is
revoked, comply with the prohibitions of phthalates, if the Commission
finds, based on scientific evidence, that such compliance is necessary
to protect the public health or safety. 15 U.S.C. 2057c(d)(2).
2. Notice of Proposed Guidance
In the Federal Register notice of July 31, 2012 (77 FR 45297), the
Commission published a proposed guidance on inaccessible phthalate-
containing component parts. As stated in the preamble to the proposed
guidance (77 FR 45299), the Commission proposed to adopt the lead
guidance for determining inaccessible component parts for phthalates,
with the exception of polyvinyl chloride (PVC or vinyl) or other
plasticized materials covering mattresses and other sleep surfaces
designed or intended by the manufacturer to facilitate sleep of
children age 3 and younger. Both the lead guidance and proposed
phthalate guidance specified that a children's product, toy, or child
care article that is completely enclosed or covered by fabric is
considered inaccessible to a child, unless the product or part of the
product in one dimension is smaller
[[Page 10504]]
than 5 centimenters. However, the lead guidance did not exclude vinyl
or other plasticized materials covering mattresses and other sleep
surfaces. The proposed phthalate guidance found that while lead is
unlikely to leach through fabric except in the case of mouthing or
swallowing an item, sheets or mattress pads that cover a vinyl sleep or
other plasticized sleep surface should not serve as a barrier to the
potential exposure of phthalates for young children. A child's skin
comes into close contact with mattresses and similar products for large
portions of a day, and a mattress cover could be dampened with a
spilled beverage, saliva, sweat, urine, or other liquid, which could
facilitate phthalate migration through a fabric covering. 74 FR 39539
(August 7, 2009).
In addition, although section 108 did not specifically disqualify
paint, coatings, or electroplating as barriers that would render
phthalates inaccessible, the Commission proposed to adopt the same
guidance with respect to inaccessibility for phthalates that was
adopted by the Commission with regard to inaccessibility of lead. The
proposed phthalates guidance stated that paint, coatings, and
electroplating may not be considered a barrier that would render
phthalate-containing component parts of toys and child care articles
inaccessible. The proposed phthalates guidance also noted that in some
applications, phthalates are added to paint, printing inks, or
coatings. 77 FR45299.
In addition, the Commission determined preliminarily that:
An accessible component part is one that is capable of
being touched or mouthed by a child;
An inaccessible component part is one that is located
inside the product and not capable of being touched or mouthed by a
child, whether or not such part is visible to a user of the product;
An inaccessible part is one that may be enclosed in any
type of material, e.g., hard or soft plastic, rubber, or metal (with
the exception of vinyl or other plasticized materials covering
mattresses or other sleep surfaces for children age 3 and younger);
To assess whether a part is inaccessible, the
accessibility probes defined in the Commission's existing regulations
for evaluating accessibility of sharp points or sharp metal or glass
edges (16 CFR 1500.48 and 1500.49) are appropriate. An ``accessible
phthalate-containing component part'' would be considered one that
contacts any portion of the specified segment of the accessibility
probe. An ``inaccessible phthalate-containing component part'' would be
considered as one that cannot be contacted by any portion of the
specified segment of the accessibility probe; and
Use and abuse tests are appropriate for evaluating whether
phthalate-containing component parts of a product become accessible to
a child during normal and reasonably foreseeable use and abuse of the
product by a child (with the exception of the bite test). The purpose
of the tests is to simulate use and damage or abuse of a product by
children and to expose potential hazards that might result from use and
abuse. 16 CFR 1500.50-1500.53.
B. Discussion of Comments to the Proposed Guidance and CPSC's Responses
Five comments were received on the proposed guidance. Two of the
comments were from industry and three from consumers or nonprofit
consumer and public health organizations. Most comments express general
support for the guidance.
1. Fabric Materials as a Barrier to Accessibility of Component Parts
Comment: One commenter states that fabric should not be considered
a barrier, regardless of the size of the component, because children
could be exposed to phthalates through the fabric.
Response: As provided in CPSC staff's briefing memo ``Guidance for
Evaluating Accessibility of Phthalate-Containing Component Parts''
dated July 13, 2012, CPSC staff is not aware of any studies that show
the propensity for phthalates to move from a phthalate-containing
material through an intact, non-phthalate-containing material, such as
an outside covering, where it could eventually reach the outside of a
product. Furthermore, CPSC staff's review showed that the non-vapor
passive movement of phthalates within a product, if it exists, would be
exceedingly slow and would never account for any more than a small,
negligible fraction of the original phthalate content of the
inaccessible phthalate-containing part. Based on CPSC staff's analysis,
the Commission finds that, in most cases, phthalates that are
inaccessible would not result in physical exposure to phthalates,
unless it is reasonably foreseeable that a component part will become
physically exposed through mouthing, swallowing, breaking, or other
children's activities, and aging of the product. Accordingly, a
children's toy or child care article that is, or contains, a phthalate-
containing part that is enclosed, encased, or covered by fabric and
passes the appropriate use and abuse tests on such covers, is
considered inaccessible to a child, unless the product, or part of the
product, in one dimension, is smaller than 5 centimeters; i.e., a
fabric-covered component part is not inaccessible if the product, or
part of the product, can be placed in a child's mouth.
Moreover, the Commission reiterates that vinyl or other plasticized
materials covering mattresses and other sleep surfaces designed or
intended by a manufacturer to facilitate sleep for children age 3 and
younger should not be considered to be made inaccessible through the
use of a fabric covering. As discussed in the preamble of the proposed
guidance, the Commission reviewed phthalate-containing vinyl or other
plasticized materials covering mattresses and sleep surfaces intended
for young children. These mattresses or sleep surfaces are too large to
be placed in a child's mouth. Although such mattresses or sleep
surfaces may be covered by fabric, such as sheets or mattress pads,
additional consideration was given to whether children would become
physically exposed to the vinyl or other plasticized materials covering
the surface through reasonably foreseeable use and abuse of the
products, including swallowing, mouthing, breaking, or other children's
activities, and the aging of the product. The Commission determined
there may be instances in which a child's skin comes into close contact
with a fabric covering over a phthalate-containing item for large
portions of a day, such as a vinyl or other plasticized material
covering a mattress or other sleep surface. Young children typically
spend more than half of each day sleeping or resting, frequently on a
mattress or similar item. While a mattress is typically covered with a
sheet or mattress pad, such non-permanently affixed coverings that are
either supplied with the mattress or provided by the consumer should
not be considered to render the underlying material inaccessible. As
with the potential transfer of phthalates by saliva during mouthing of
an item, a mattress cover dampened with a spilled beverage, saliva,
sweat, urine, or other liquid, could facilitate phthalate migration
through the fabric. Furthermore, a nonpermanent covering cannot be
assumed to be in use at all times; if it is not, the mattress could no
longer be considered inaccessible. For these reasons, vinyl (or other
plasticized material) covered mattresses/sleep surfaces, which contain
phthalates, designed or intended by a manufacturer
[[Page 10505]]
to facilitate sleep for children age 3 and younger, should not be
considered to be made inaccessible through the use of a fabric
covering.
Comment: One commenter states that the proposed guidance ``exempts
components covered in fabric provided that the underlying component is
not smaller than 5 centimeters in any one dimension.'' According to the
commenter, any exposure to phthalates-containing component parts within
fabric coverings is very low and all phthalate-containing components
parts covered by fabric should be exempt, irrespective of the size of
the part. The commenter also suggests that a de minimis exception
should be considered for accessible small plasticized parts.
Response: The commenter misinterprets the fabric covering
restriction in the proposed guidance on inaccessible phthalate-
containing component parts. The proposed guidance states that ``a
children's product that is or contains a phthalate-containing part
which is enclosed, encased, or covered by fabric and passes the
appropriate use and abuse tests on such covers, is inaccessible to a
child unless the product or part of the product in one dimension is
smaller than 5 centimeters.'' However, the 5 centimeter measure is
applied to the fabric-covered part or product (i.e., a fabric covered
plastic button), not to the size of the underlying phthalate-containing
component part. If a toy or part of a toy in one dimension is smaller
than 5 centimeters, it can be placed in a child's mouth (i.e., a fabric
covered plastic ear on a stuffed animal). A phthalate-containing
component part which is encased by a fabric covering is considered to
be accessible to a child if the part or product is smaller than 5
centimeters in any dimension because such a part or product could be
placed in a child's mouth, and the fabric is not expected to perform as
a barrier to saliva or other fluids or to prevent direct contact by the
child with the saliva or other fluid after a fluid's contact with the
phthalate-containing part. Even if a fabric covering passes the
applicable use and abuse tests, such a covering is not a barrier to the
underlying material if the product can be placed in the mouth because
it is smaller than 5 centimeters.
If the phthalate-containing component part that is encased by
fabric covering is 5 centimeters or greater in dimension, such a part
of product is considered to be inaccessible to a child, because the
part or product in not likely to be put in the mouth or swallowed
(i.e., plastic electronic box inside a stuffed animal). As discussed
above, however, vinyl or other plasticized material covering a mattress
or other sleep surface which is designed or intended by a manufacturer
to facilitate sleep of children age 3 and younger, even when covered
with a sheet or mattress pad, will still be considered accessible given
that the foreseeable use and abuse of the product, including spilled
beverages, saliva, sweat, urine, or other liquids, may facilitate
phthalate migration through the fabric.
The statute does not provide for a de minimis exception for
accessible component parts, and the Commission is not considering in
this guidance such exceptions for accessible phthalate-containing
children's toys and child care articles. However, we note that a CHAP
has been convened to study the effects on children's health of all
phthalates and phthalate alternatives, as used in children's toys and
child care articles. Based on the findings and recommendations of the
CHAP, any guidance concerning phthalates may be modified and revised,
as appropriate.
Comment: The same commenter also states that the exclusion of
fabric materials as a barrier to accessibility for phthalate-containing
parts or products smaller than 5 centimeters is inconsistent with the
Commission's use and abuse testing.
Response: The proposed guidance provides that accessibility of
component parts, as a result of normal and reasonably foreseeable use
and abuse of the product, should be evaluated using the use and abuse
tests under the Commission's regulations at 16 CFR 1500.50 through
1500.53 (excluding the bite test in paragraph (c) of Sec. Sec.
1500.51-1500.53). We disagree that the exclusion of fabric materials as
a barrier to accessibility is inconsistent with the Commission's use
and abuse testing. The Commission finds, in general, that fabric
coverings can be considered barriers to the underlying materials
because such coverings prevent direct physical contact with the
phthalate-containing parts. The appropriate use and abuse tests, such
as the test for the integrity of seams, should be used to evaluate
fabric coverings to ensure that the component parts remain physically
inaccessible to a child. Use and abuse testing generally is applied to
evaluate whether a component part may become physically accessible as a
result of reasonably foreseeable use and abuse of the product,
including swallowing, mouthing, breaking, or other children's
activities. Historically, this testing has been used to evaluate the
presence of physical hazards, such as small parts, which may be choking
hazards, or sharp points and edges. In the case of lead-containing or
phthalate-containing component parts, these tests are used to evaluate
the potential for physical contact with the parts. The material beneath
a fabric covering should not be considered to be inaccessible to a
child if the part or product is smaller than 5 centimeters in any
dimension because such a part or product could be placed in a child's
mouth, and fabric is not expected to perform as a barrier to saliva or
other fluids or to prevent direct contact by the child with the saliva
or other fluid after a fluid's contact with the phthalate-containing
part. Even if a fabric covering passes the applicable use and abuse
tests, such a covering is not a barrier to the underlying material if
the product can be placed in the mouth.
2. Exclusion of the ``Bite Test'' from Use and Abuse Testing
Comment: Two commenters question the exclusion of the ``bite test''
from the use and abuse testing and requested that it be included in the
guidance.
Response: Currently, the Commission does not use the bite test
specified in 16 CFR 1500.51-1500.53), as a result of a court case
(Clever Idea Co., Inc. v. Consumer Product Safety Commission, 385 F.
Supp. 688 (E.D. N.Y. 1974)) that questioned the appropriateness of this
test. Because the bite test currently is not applied as part of use and
abuse testing for consumer products, it will not be applied for the
purposes of evaluating products for accessibility of phthalate-
containing component parts. However, this requirement may be modified
in a future proceeding if the bite test is reevaluated.
3. Requirements for Labeling of Art Materials
Comment: One commenter requests consistency among the requirements
for paints and other surface coatings for lead and phthalates and the
requirements under ASTM D 4236 and ASTM F 963 that address art
materials. This commenter specifically requests that bottles of paint
available in retail stores should comply with all requirements because
such paint could be used by children or on products for children.
Response: This comment is outside the scope of this guidance, which
addresses the issue of when a phthalate-containing component part of a
children's toy or child care article is considered to be inaccessible
to a child. The Standard Consumer Safety Specification for Toy Safety,
ASTM F 963 requires that all art materials comply with the Labeling of
Hazardous Art Materials Act (LHAMA). In addition to the LHAMA
requirements discussed above, art materials that are designed or
[[Page 10506]]
intended primarily for children 12 years of age or younger, are also
required, like all children's products, to comply with the requirements
of the CPSIA, including third party testing and certification.
C. Effective Date
Although guidance documents do not require a particular effective
date under the Administrative Procedure Act, 5 U.S.C. 553(d)(2), the
Commission recognizes the need for providing the guidance
expeditiously. In addition, material published in the Code of Federal
Regulations must have an effective date. Accordingly, the guidance will
take effect upon publication in the Federal Register.
D. Final Guidance
The Commission is issuing the final guidance without substantive
change from the proposed guidance.
List of Subjects in 16 CFR Part 1199
Business and industry, Infants and children, Consumer protection,
Imports, Toys.
For the reasons stated above, the Commission adds 16 CFR part 1199
to read as follows:
PART 1199-- CHILDREN'S TOYS AND CHILD CARE ARTICLES CONTAINING
PHTHALATES: GUIDANCE ON INACCESSIBLE COMPONENT PARTS
Authority: 15 U.S.C. 1251-1289, 86 Stat. 1207, 125 Stat. 273.
Sec. 1199.1 Children's toys and child care articles: Phthalate-
containing inaccessible component parts.
(a) Section 108 of the Consumer Product Safety Improvement Act of
2008 (CPSIA) permanently prohibits the sale of any ``children's toy or
child care article'' containing more than 0.1 percent of three
specified phthalates (di-(2-ethylhexyl) phthalate (DEHP), dibutyl
phthalate (DBP), and benzyl butyl phthalate (BBP)). Section 108 of the
CPSIA also prohibits, on an interim basis, ``toys that can be placed in
a child's mouth'' or ``child care article'' containing more than 0.1
percent of three additional phthalates (diisononyl phthalate (DINP),
diisodecyl phthalate (DIDP), and di-n-octyl phthalate (DnOP)). A
``children's toy'' is defined 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 child plays. A toy 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 by a child so that it can be sucked and chewed. If
the children's product can only be licked, it is not regarded as able
to be placed in the mouth. If a toy or part of a toy in one dimension
is smaller than 5 centimeters, it can be placed in the mouth. The term
``child care article'' means a consumer product designed or intended by
the manufacturer to facilitate sleep or the feeding of children age 3
years and younger, or to help such children with sucking or teething.
(b) Section 108(d) of the CPSIA provides that the prohibitions in
paragraph (a) of this section do not apply to component parts of a
children's toy or child care article that are not accessible to
children through normal and reasonably foreseeable use and abuse of
such product, as determined by the Commission. A component part is not
accessible if it is not physically exposed, by reason of a sealed
covering or casing, and does not become physically exposed through
reasonably foreseeable use and abuse of the product, including
swallowing, mouthing, breaking, or other children's activities, and the
aging of the product.
(c) Section 108(d)(3) of the CPSIA directs the Commission to
promulgate a rule to provide guidance with respect to what product
components or classes of components will be considered to be
inaccessible for a children's toy or child care article that contains
phthalates or adopt the same guidance with respect to inaccessibility
that was adopted by the Commission with regard to accessibility of lead
under section 101(b)(2)(B) (15 U.S.C. 1278a(b)(2)(B)), with additional
consideration, as appropriate, of whether such component can be placed
in a child's mouth. 15 U.S.C. 2057c(d)(3). The Commission adopts the
same guidance with respect to inaccessibility for the phthalates that
was adopted by the Commission with regard to accessibility of lead,
however, vinyl (or other plasticized material) covered mattresses/sleep
surfaces, that contain phthalates that are designed or intended by the
manufacturer to facilitate sleep of children age 3 and younger, are
considered accessible and would not be considered inaccessible through
the use of fabric coverings, including sheets and mattress pads.
(d) The accessibility probes specified for sharp points or edges
under the Commission's regulations at 16 CFR 1500.48-1500.49 should be
used to assess the accessibility of phthalate-containing component
parts of a children's toy or child care article. A phthalate-containing
component part would be considered accessible if it can be contacted by
any portion of the specified segment of the accessibility probe. A
phthalate-containing component part would be considered inaccessible if
it cannot be contacted by any portion of the specified segment of the
accessibility probe.
(e) For children's toys or child care articles intended for
children that are 18 months of age or younger, the use and abuse tests
set forth under the Commission's regulations at 16 CFR 1500.50 and 16
CFR 1500.51 (excluding the bite test of Sec. 1500.51(c)), should be
used to evaluate accessibility of phthalate-containing component parts
of a children's toy or child care article as a result of normal and
reasonably foreseeable use and abuse of the product.
(f) For children's toys or child care articles intended for
children that are over 18 months, but not over 36 months of age, the
use and abuse tests set forth under the Commission's regulations at 16
CFR 1500.50 and 16 CFR 1500.52 (excluding the bite test of Sec.
1500.52(c)), should be used to evaluate accessibility of phthalate-
containing component parts of a children's toy or child care article as
a result of normal and reasonably foreseeable use and abuse of the
product.
(g) For children's toys intended for children that are over 36
months, but not over 96 months of age, the use and abuse tests set
forth under the Commission's regulations at 16 CFR 1500.50 and 16 CFR
1500.53 (excluding the bite test of Sec. 1500.53(c)), should be used
to evaluate accessibility of phthalate-containing component parts of a
children's toy as a result of normal and reasonably foreseeable use and
abuse of the product.
(h) For children's toys intended for children over 96 months
through 12 years of age, the use and abuse tests set forth under the
Commission's regulations at 16 CFR 1500.50 and 16 CFR 1500.53
(excluding the bite test of Sec. 1500.53(c)) intended for children
ages 37-96 months should be used to evaluate accessibility of
phthalate-containing component parts of a children's toy as a result of
normal and reasonably foreseeable use and abuse of the product.
(i) Because the Commission adopts the same guidance with respect to
inaccessibility for phthalates that was adopted by the Commission with
regard to inaccessibility of lead, paint, coatings, and electroplating
may not be considered a barrier that would render phthalate-containing
component parts of toys and child care articles inaccessible. A
children's toy or child care article that is or contains a phthalate-
containing part that is enclosed, encased, or covered by fabric and
passes the appropriate use and
[[Page 10507]]
abuse tests on such covers, is considered inaccessible to a child,
unless the product or part of the product, in one dimension, is smaller
than 5 centimeters. However, vinyl (or other plasticized material)
covered mattresses/sleep surfaces that contain phthalates that are
designed or intended by the manufacturer to facilitate sleep of
children age 3 and younger, are considered accessible and would not be
considered inaccessible through the use of fabric coverings, including
sheets and mattress pads.
(j) The intentional disassembly or destruction of products by
children older than age 8 years, by means or knowledge not generally
available to younger children, including use of tools, will not be
considered in evaluating products for accessibility of phthalate-
containing components.
Dated: February 11, 2013.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2013-03400 Filed 2-13-13; 8:45 am]
BILLING CODE 6335-01-P
