[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