[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Notices]
[Pages 22518-22520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08858]


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CONSUMER PRODUCT SAFETY COMMISSION

[Docket No. CPSC-2011-0081]


Request for Information Regarding Third Party Testing for Lead 
Content, Phthalate Content, and the Solubility of the Eight Elements 
Listed in ASTM F963-11

AGENCY: U.S. Consumer Product Safety Commission.

ACTION: Notice.

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SUMMARY: The Consumer Product Safety Commission (CPSC, or Commission) 
is issuing a notice seeking information on whether there are materials 
that can be determined not to include a prohibited element (lead or 
certain other elements) or chemical (six prohibited phthalates), such 
that third party testing is not required. The Commission also seeks 
information on materials that do not, and will not, contain the 
prohibited elements or chemicals in concentrations above their 
applicable maximum limit.

DATES: Written comments must be submitted by June 17, 2013.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2010-
0037 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 http://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, U.S. Consumer 
Product Safety Commission, Room 820, 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 notice. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
(such as a Social Security Number) electronically; if furnished at all, 
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: Randy Butturini, Project Manager, 
Office of Hazard Identification and Reduction, U.S. Consumer Product 
Safety Commission, 4330 East West Highway, Bethesda, MD 20814; 301-504-
7562; email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    The Consumer Product Safety Act (CPSA) generally requires that 
children's products be tested by a third party CPSC-accepted laboratory 
for compliance with the applicable children's product safety rules. The 
Commission notes, regardless of any third party testing obligation, 
compliance with the children's products requirements discussed in this 
Request for Information (RFI) is always required.
    This RFI seeks information on whether there are materials, used in 
the manufacture of consumer products, that can be determined not to 
include a prohibited element (lead or certain other elements) or 
chemical (the six prohibited phthalates that are listed in section 108 
of the Consumer Product Safety Improvement Act of 2008 (CPSIA)), such 
that third party testing is not required. This RFI also seeks 
information on materials that do not, and will not, contain the 
prohibited elements or chemicals in concentrations above the legally 
allowable limit. Information provided by the public concerning the 
characteristics of such materials will be used to develop recommended 
courses of action for the Commission.
    This RFI consists of four parts, seeking data and information 
concerning the following children's products and materials used to 
manufacture those products:
     Toys subject to ASTM F963-11, Standard Consumer Safety 
Specification for Toy Safety, and the presence, if any, or at what 
levels, of the eight elements designated in section 4.3.5 of the 
standard. The solubility of each element is limited to no more than the 
levels listed in Tables 1 and 2 of the standard. Additionally, for 
accessible

[[Page 22519]]

component parts of toys primarily intended for children 12 years old 
and younger, the lead content must be no greater than 100 parts per 
million (ppm), and the lead content of paints or surface coatings must 
be no greater than 90 ppm, in accordance with section 101 of the CPSIA;
     Toys and certain child care articles, and the presence, if 
any, or at what levels, of the six prohibited phthalates listed in 
section 108 of the CPSIA. These products are subject to a maximum 
concentration of 1000 ppm (or 0.1 percent) for each of the six 
prohibited phthalates;
     Manufactured woods and the presence, if any, or at what 
levels, of lead. Accessible manufactured wood in children's products is 
subject to the maximum allowable lead content requirement of 100 ppm;
     Synthetic food dyes and the presence, if any, or at what 
levels, of lead. Accessible synthetic food dyes in children's products 
are subject to the maximum allowable lead content requirement of 100 
ppm.

II. Background

A. Requirements

    The CPSIA made the ASTM International toy safety standard, ASTM 
F963-11, a mandatory children's product safety standard. ASTM F963-11 
includes restrictions on the maximum solubility of eight elements 
(antimony, arsenic, barium, cadmium, chromium, lead, mercury, and 
selenium) in coatings and substrates of toys subject to that standard.
    The CPSIA also limits the concentration of six prohibited 
phthalates in component parts of children's toys and child care 
articles.
    The CPSIA limits the lead content of component parts of children's 
products to 100 ppm (currently) in each accessible component part. A 
children's product is a consumer product that is designed and intended 
primarily for children 12 years old and younger.

B. Third Party Testing

    Section 14(a) of the CPSA, as amended by section 102 of the CPSIA, 
requires third party testing of: children's products for lead content; 
toys and child care articles for the prohibited phthalates; and toys 
subject to the ASTM F963-11 toy safety standard for eight elements. For 
children's products, toys, and child care articles subject to CPSIA 
requirements, and toys subject to ASTM F963-11 that may contain these 
prohibited materials, third party testing is required for 
certification, material change, and periodic testing.
    Section 14(a) of the CPSA, as amend by section 102 of the CPSIA, 
requires third party testing for lead content in certain products and 
materials. The Commission, however, has determined that certain 
products or materials inherently do not contain lead at levels that 
exceed the specified lead content limits, and therefore, no third party 
testing of these products and materials is required. See 16 CFR 1500.91 
for a list of the materials.
    In addition to making these determinations, the Commission 
published a rule containing procedures and requirements for future 
Commission determinations regarding certain materials or products that 
do not, and would not, exceed the lead limits. 16 CFR 1500.89. 
Interested parties may consult the determinations rule at 16 CFR 
1500.91 and the determinations procedures rule at 16 CFR 1500.89 for 
additional information about these prior Commission actions.
    Section 14 of the CPSA requires third party testing of children's 
toys and certain child care articles for compliance with the phthalates 
requirements. In August 2009, the Commission made available a statement 
of policy on testing with respect to the CPSIA section 108 restrictions 
for phthalates in component parts of children's toys and child care 
articles, which can be found at: http://www.cpsc.gov/PageFiles/110003/componenttestingpolicy.pdf. In August 2012, in the notice of 
requirements (NOR), Third Party Testing for Certain Children's 
Products; Notice of Requirements for Accreditation of Third Party 
Conformity Assessment Bodies to Assess Conformity With the Limits on 
Phthalates in Children's Toys and Child Care Articles, the Commission 
included a footnote regarding materials that are not expected 
inherently to contain phthalates, and thus, do not require third party 
testing. The NOR can be found at: http://www.gpo.gov/fdsys/pkg/FR-2011-08-10/pdf/2011-19678.pdf.
    Public Law 112-28 (PL 112-28), enacted on August 11, 2011, amended 
section 14 of the CPSA and directed the CPSC to consider ways to reduce 
the third party testing burden consistent with assuring compliance of 
children's products to the applicable consumer product safety rules. 
The resulting briefing package, dated August 29, 2012, is available at: 
http://www.cpsc.gov/PageFiles/129398/reduce3pt.pdf. In response to the 
third party testing burden reduction briefing package, on January 18, 
2013, the Commission directed staff to develop an RFI to solicit 
information on the four topics listed above. The fiscal year 2013 
Operating Plan text directing the staff can be found on page 24 at: 
http://www.cpsc.gov/Global/Budget/2013OperatingPlan.pdf.

III. General Information Requested

    In preparing comments to submit to CPSC regarding one or more 
sections of the RFI, commenters should include information on the 
following:
     The chemicals and raw materials used in manufacturing a 
specific product or component part, and their typical or possible 
concentrations of lead, phthalates, or the elements specified in the 
ASTM F963-11 toy safety standard;
     The extent to which recycled materials or other materials 
(such as plastic color concentrates or other additives) with 
potentially variable concentrations of lead, phthalates, or the 
elements specified in the ASTM F963-11 toy safety standard are used in 
manufacturing a specific product or component part;
     The manufacturing processes and conditions (such as 
potential sources of contaminants) that could increase the 
concentration in the product or material of lead, phthalates, or the 
elements specified in the ASTM F963-11 toy safety standard;
     The possibility that variations among worldwide 
manufacturers in their use of raw materials and processes could impact 
manufacturers' ability to meet consistently the concentration limits 
for lead, phthalates, or the elements specified in the ASTM F963-11 toy 
safety standard; and
     Other relevant factors that could impact the concentration 
in products or materials of lead, phthalates, or the elements specified 
in the ASTM F963-11 toy safety standard.
    In addition to identifying the materials that could be determined 
to be compliant with an applicable chemical limit without requiring 
third party testing, commenters should explain in detail why such a 
conclusion could be made. Commenters should explain their reasons and 
provide evidence to support their claim that present and future 
production will continue to comply with the applicable children's 
product safety rules.

IV. Additional Information Requested

A. Children's Toys and the Eight Elements in ASTM F963-11

    Section 4.3.5 of ASTM F963-11 establishes limits on the maximum 
soluble content of the eight elements in paints, surface coatings, and 
substrates of toys subject to the standard. (Of these elements, the 
standard--and the CPSIA--limit the total lead content in

[[Page 22520]]

paints and surface coatings to 90 ppm and the total lead content of 
accessible substrates to 100 ppm.) Some of the ways compliance with the 
soluble limit could be demonstrated are through:
     Component part testing showing that all of the component 
parts of the toy have a solubility of one or more of the eight elements 
of no more than their maximum allowable values; or
     Showing that the component parts' content limit for an 
element is at or below the maximum solubility limit allowed, which also 
indicates compliance with that limit. (This alternate route to show 
compliance is provided for by section 8.3.1 of the ASTM F963-11 
standard).
    The commenter should explain, in addition to the requested general 
information, how consistent compliance to the soluble limit of 
element(s) in a material or component part, can be assured without 
third party testing.

B. Phthalate Concentrations in Plasticized Component Parts

    Section 108 of the CPSIA permanently prohibits the sale of any 
``children's toy or child care article'' containing concentrations of 
more than 0.1 percent of the following chemicals:
     dibutyl phthalate (DBP);
     butyl benzyl phthalate (BBP); or
     di(2-ethylhexyl) phthalate (DEHP).
    Section 108 prohibits on an interim basis the sale of ``any 
children's toy that can be placed in a child's mouth'' or ``child care 
article'' containing concentrations of more than 0.1 percent of:
     di-n-octyl phthalate (DnOP);
     diisononyl phthalate (DINP); or
     diisodecyl phthalate (DIDP),

pending review by a Chronic Hazard Advisory Panel (CHAP).
    Section 108 of the CPSIA defines the terms ``children's toy,'' 
``children's toy that can be placed in a child's mouth,'' and ``child 
care article.'' Additional information is available at: http://www.cpsc.gov/Regulations-Laws-Standards/CPSIA/Phthalates/Phthalates-Information.
    Phthalates commonly are used as plasticizers (softeners) in 
plastics. Phthalates also are used in other products, including, but 
not limited to, paints, inks, adhesives, sealants, air fresheners, and 
scented products. In August 2009, the Commission issued a statement of 
policy listing materials that:
     May contain phthalates, and therefore, should always be 
tested; and
     Normally do not contain phthalates, and therefore, may not 
require testing.
    In the August 2012 NOR, a footnote indicated that the following 
materials are not expected inherently to contain phthalates, and thus, 
do not require third party testing::
     Untreated/unfinished wood;
     Metal;
     Natural fibers;
     Natural latex; and
     Mineral products.
    Staff is interested in information relating to materials that do 
not contain the prohibited phthalates in amounts greater than 1000 ppm. 
In addition to the requested general information, the commenter should 
explain how consistent compliance to the phthalates limits in a 
material or component part can be assured without third party testing.

C. Lead Content in Manufactured Wood Products

    For the purposes of this RFI, ``manufactured wood'' refers to 
composite wood products that are wood-based materials, such as particle 
board, medium density fiber board, and plywood, consisting largely of 
natural, untreated wood and glues, adhesives, waxes, resins, and 
similar materials. Only these constituents are the subject of the RFI.
    The Commission previously determined that natural wood (untreated, 
unadulterated, and uncoated) does not, and will not, contain lead in 
concentrations in excess of 100 ppm, as detailed in 16 CFR 1500.91. The 
Commission has not made a similar determination for the adhesives or 
other possible constituents of a manufactured wood product.
    Manufactured wood products are complex, nonhomogeneous products. 
Therefore, some of the ways compliance with the lead content limit 
could be demonstrated are:
     By testing a sample of a finished product, which must 
contain no more than 100 ppm lead;
     Through component part testing of all the constituents of 
the manufactured wood, with test results showing that all of the 
constituents used to make the finished product contain no more than 100 
ppm lead; or
     By demonstrating that a finished product will never exceed 
100 ppm lead content, even if one or more constituents of the 
manufactured wood product contains lead in excess of 100 ppm.
    As provided in 16 CFR 1500.91, a natural wood component part does 
not require testing.
    The commenter should explain, in addition to the requested general 
information, how consistent compliance to the lead concentration limit 
of the finished manufactured wood or the constituents can be assured 
without third party testing.

D. Synthetic Food Additives

    As detailed in 16 CFR 1500.91, the Commission previously determined 
that natural materials, such as natural fibers and other plant-derived 
and animal-derived materials, do not contain lead in concentrations 
above 100 ppm. These natural materials could include substances that 
may be used as food additives. However, certain synthetic materials 
that may be used as food additives are not included in the Commission 
determinations. Therefore, if a synthetic food additive is used in 
manufacturing a children's product, the resulting finished product or 
component part is subject to the CPSC requirements for lead content for 
children's products, including the third party testing requirements.
    Substances used as food additives are subject to the requirements 
of the U.S. Food and Drug Administration (FDA), including 21 CFR part 
172. Because 21 CFR part 172 does not require third party testing, 
compliance with FDA requirements is not sufficient to indicate 
compliance with section 101 of the CPSIA. To the extent that any 
synthetic food additive can be shown consistently not to contain lead 
at levels that exceed the specified lead content limits, 
recommendations could be made for future Commission action.
    The commenter should explain, in addition to the requested general 
information, how consistent compliance to the lead content limit of the 
synthetic food additive(s) can be assured without third party testing.

    Dated: April 11, 2013.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2013-08858 Filed 4-15-13; 8:45 am]
BILLING CODE 6355-01-P