[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Proposed Rules]
[Pages 45297-45301]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18620]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1199
[Docket No. CPSC-2012-0040]
Children's Toys and Child Care Articles Containing Phthalates;
Proposed Guidance on Inaccessible Component Parts
AGENCY: Consumer Product Safety Commission.
ACTION: Proposed guidance.
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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
[[Page 45298]]
reasonably foreseeable use and abuse of such product. In this document,
the Consumer Product Safety Commission (CPSC or Commission) proposes
guidance on inaccessible component parts in children's toys or child
care articles subject to section 108 of the CPSIA.
DATES: Written comments and submissions in response to this notice must
be received by October 1, 2012
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2012-
0040, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.
To ensure timely processing of comments, the Commission is no
longer accepting comments submitted by electronic mail (email) except
through www.regulations.gov.
Written Submissions
Submit written submissions in the following way:
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions), preferably in five copies, to: Office of the Secretary,
Consumer Product Safety Commission, 4330 East West Highway, Bethesda,
MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name
and docket number for this proposed guidance. All comments received may
be posted without change, including any personal identifiers, contact
information, or other personal information provided, to http://www.regulations.gov. Do not submit confidential business information,
trade secret information, or other sensitive or protected information
electronically. Such information should be submitted in writing.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov.
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, 4330 East-West Highway, Bethesda,
MD 20814; telephone (301) 504-7254; khatlelid@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background
1. Prohibition on Certain Phthalates
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 and younger, or to help such children
with sucking or teething.'' 15 U.S.C. 2057c(g).
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 the Commission.
2. Inaccessible Component Parts and the Phthalates Prohibition
Public Law 112-28 amended section 108(d) of the CPSIA to provide an
exclusion for certain products containing inaccessible phthalates
component parts. That section states:
The prohibitions * * * 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. A component part is
not accessible under this paragraph 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 shall
include swallowing, mouthing, breaking, or other children's
activities, and the aging of the product.
15 U.S.C. 2057c(d)(1).
The Commission was directed within 1 year after the date of
enactment of Public Law 112-28 [enacted August 12, 2011] 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 regards 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 exclusion for inaccessible component parts for phthalates
mirrors the language on inaccessible parts in the CPSIA with regard to
the limits on lead content in children's products. The interpretative
rule on lead provided that 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. 15 U.S.C.
1278a(b)(2). However, paint, coatings, or electroplating could not be
considered to be a barrier that would render lead in the substrate to
be inaccessible to a child. 15 U.S.C. 1278a(b)(3). Section 108 did not
specifically disqualify paint, coatings, or electroplating as barriers
that would render phthalates inaccessible. Because the Commission
proposes to adopt the same guidance with respect to
[[Page 45299]]
inaccessibility for phthalates that was adopted by the Commission with
regard to inaccessibility of lead, the proposed guidance states 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. Moreover, in some applications,
phthalates are added to paint, printing inks, or coatings. However, the
Commission seeks comments, information, and data regarding whether
certain paint, coatings, or electroplating could ever be considered a
barrier in the context of phthalates, and whether such materials could
result in sealed covering or casing that would not become physically
exposed through reasonably foreseeable use and abuse of the product.
In addition, Public Law 112-28 also includes a provision for
phthalates, which is not contained in the statutory requirements for
assessing inaccessibility for lead in children's products. 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).
B. Proposed Guidance for Inaccessible Component Parts in Phthalates
The Commission's interpretive rule regarding inaccessible component
parts with respect to lead content was published in the Federal
Register on August 7, 2009 (74 FR 39535) and codified at 16 CFR 1500.87
(Children's products containing lead: Inaccessible component parts).
The Commission proposes to adopt the lead guidance with respect to
inaccessibility 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.
Accordingly, this proposed guidance would adopt the same
definitions and tests used in the interpretative rule regarding
inaccessibility of lead-containing parts. An ``accessible component
part'' is one that a child may touch, and an ``inaccessible component
part'' is one that is located inside the product, and cannot be touched
by a child, even if such a part is visible to a user of the product. An
accessible component is defined as one where children may contact a
lead-containing component part with their fingers or tongues. The tests
to determine whether parts are accessible are identical to those
already in use by the Commission for addressing sharp points and sharp
metal or glass edges on toys or other articles intended for use by
children. The Commission's regulations under 16 CFR 1500.48-1500.49
provide specific technical requirements for determining accessibility
of sharp points or edges through the use of accessibility probes. These
sections provide that an accessible sharp point or edge is present in
the product if the test indicates that any part of the specified
portion of the accessibility probe contacts the sharp part. Thus, an
``accessible component part'' of a children's product is defined as one
that can be contacted by any part of the specified portion of the
accessibility probe. The regulations at 16 CFR 1500.48-49 provide that
a test for accessibility of sharp points or edges shall be applied
before and after use and abuse tests, referencing 16 CFR 1500.50
through 1500.53 (excluding the bite test--paragraph (c) of 16 CFR
1500.51-1500.53).
Use and abuse testing may also be used to evaluate accessibility of
phthalate-containing component parts of children's toys and child care
articles as a result of normal and reasonably foreseeable use and abuse
of the product. The scope of the use and abuse testing regulations does
not cover products for children over 96 months of age. However, 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.'' Therefore, the proposed
guidance for the testing of products for determining accessibility
based on the use and abuse tests will be extended to children older
than 96 months of age and up through age 12 years. This proposed
guidance provides that the testing indicated for products for children
aged 37-96 months of age should also be used to evaluate the products
for children up through age 12 years. Further, as children 12 years of
age or younger grow and mature, they become, in many respects,
indistinguishable from children older than 12 years, and even adults.
Consequently, the intentional disassembly or destruction of products by
children older than age 8 years, by means or knowledge not generally
available to younger children, should not be considered in evaluating
products for accessibility of phthalate-containing components. For
example, accessibility arising from the use of tools, such as a
screwdriver, should not be considered in accessibility and use and
abuse testing.
The interpretive rule on lead also specified that a lead-containing
part of a children's product that is enclosed or covered by fabric is
to be considered inaccessible to a child, unless the product, or part
of the product, in one dimension, is smaller than 5 centimeters. This
provision addressed the possibility that a fabric covering is not a
suitable barrier to the potential transfer of lead from the part to a
child, if the part can be placed in a child's mouth. As is the case
with lead, a fabric covering may not be a suitable barrier to the
potential transfer of phthalates from a product or component part to a
child, if the part can be placed in a child's mouth. If the product can
be mouthed, the chemical that is present could mix with saliva that
soaks through the fabric and then be transferred back into a child's
mouth during further mouthing activity. With the exception of certain
vinyl (or other plasticized material) covered mattresses/sleep
surfaces, as discussed further below, 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 and parts, would be considered to be
inaccessible to a child, unless the product or part of the product, in
one dimension, is smaller than 5 centimeters. Such fabric-covered items
(including dolls, or plush toys with internal plasticized structural
parts or housing for electronic parts) should be evaluated for the
integrity of the coverings, including seams, using the appropriate use
and abuse tests at 16 CFR 1500.50 through 1500.53 (excluding the bite
test--paragraph (c) of 16 CFR 1500.51-1500.53). In addition, because
the material beneath a fabric covering would be considered to be
accessible to a child in the case that mouthing or swallowing of the
part may occur, use and abuse testing should be used to evaluate the
potential for small components to be removed from products, using the
appropriate tests at 16 CFR 1500.50 through 1500.53 (excluding the bite
test--paragraph (c) of 16 CFR 1500.51-1500.53).
Section 108(d)(3)(B) provides that if the Commission elects to
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) of the CPSIA, the Commission must give
``additional consideration, as
[[Page 45300]]
appropriate, of whether such component can be placed in a child's
mouth.'' 15 U.S.C. 2057c(d)(3). Accordingly, with respect to child care
articles, the Commission reviewed phthalate-containing vinyl or other
plasticized materials covering mattresses and sleep surfaces designed
or intended by the manufacturer to facilitate sleep of children age 3
and younger that have removable fabric covers. 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. 15 U.S.C. 2057c(d)(1). 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, likely on a mattress or similar item.\1\ 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 to facilitate sleep for children age 3
and younger, should not be considered to be made inaccessible through
the use of a fabric covering.
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\1\ U.S. EPA (Environmental Protection Agency). (2011) Exposure
factors handbook: 2011 Edition. National Center for Environmental
Assessment, Washington, DC; EPA/600/R-09/052F. Available from the
National Technical Information Service, Springfield, VA, and online
at http://www.epa.gov/ncea/efh.
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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.
Currently, the CHAP is working on a report, including recommendations
to the Commission. Accordingly, any guidance concerning phthalates may
be modified and revised, as appropriate, based on the findings and
recommendations of the CHAP.
C. Effective Date
The Commission was directed to provide guidance on phthalate-
containing inaccessible component parts by August 12, 2012. 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.
Accordingly, the proposed guidance would take effect upon publication
of a final guidance in the Federal Register.
List of Subjects in 16 CFR Part 1199
Business and industry, Infants and children, Consumer protection,
Imports, Toys.
D. Conclusion
For the reasons stated above, the Commission proposes to add 16 CFR
part 1199, 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 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
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) 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, by August 12, 2012, 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 regards 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 regards to accessibility of lead.
(d) The accessibility probes specified for sharp points or edges
under the Commissions' regulations at 16 CFR 1500.48-1500.49 will 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
[[Page 45301]]
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)), will 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)),
will 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)), will 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 aged 37-
96 months will 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 proposes to adopt 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 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 which 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: July 26, 2012.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2012-18620 Filed 7-30-12; 8:45 am]
BILLING CODE 6355-01-P