[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Proposed Rules]
[Pages 45297-45301]
From the Federal Register Online via the Government Publishing 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; [email protected].

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