[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Rules and Regulations]
[Pages 78651-78657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31723]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1251

[Docket No. CPSC-2011-0081]


Toys: Determination Regarding Heavy Elements Limits for 
Unfinished and Untreated Wood

AGENCY: U.S. Consumer Product Safety Commission.

ACTION: Final rule.

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SUMMARY: The Consumer Product Safety Commission (``Commission,'' or 
``CPSC'') is issuing a final rule determining that unfinished and 
untreated trunk wood does not contain heavy elements that would exceed 
the limits specified in the Commission's toy standard, ASTM F963-11. 
Based on this determination, unfinished and untreated trunk wood in 
toys does not require third party testing for the heavy element limits 
in ASTM F963.

DATES: The rule is effective on January 19, 2016.

FOR FURTHER INFORMATION CONTACT: John W. Boja, Lead Compliance Officer, 
Office of Compliance, U.S. Consumer Product Safety Commission, 4330 
East West Hwy., Room 610M, Bethesda, MD 20814; 301-504-7300: email: 
[email protected].

SUPPLEMENTARY INFORMATION:

A. Background

1. Third Party Testing and Burden Reduction

    Section 14(a) of the Consumer Product Safety Act, (``CPSA''), as 
amended by the Consumer Product Safety Improvement Act of 2008 
(``CPSIA''), requires that manufacturers of products subject to a 
consumer product safety rule or similar rule, ban, standard or 
regulation enforced by the CPSC, must certify that the product complies 
with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). For 
children's products, certification must be based on testing conducted 
by a CPSC-accepted third party conformity assessment body. Id. Public 
Law 112-28 (August 12, 2011) directed the CPSC to seek comment on 
``opportunities to reduce the cost of third party testing requirements 
consistent with assuring compliance with any applicable consumer 
product safety rule, ban, standard, or regulation.'' Public Law 112-28 
also authorized the Commission to issue new or revised third party 
testing regulations if the Commission determines ``that such 
regulations will reduce third party testing costs consistent with 
assuring compliance with the applicable consumer product safety rules, 
bans, standards, and regulations.'' Id. 2063(d)(3)(B).

2. CPSC's Toy Standard

    Section 106 of the CPSIA states that the provisions of ASTM 
International (``ASTM''), Consumer Safety Specifications for Toy Safety 
(``ASTM F963,'' or ``toy standard''), ``shall be considered to be 
consumer product safety standards issued by the Commission under 
section 9 of the CPSA (15 U.S.C. 2058).'' \1\ Thus, toys subject to 
ASTM F963-11, the current mandatory version of the standard, must be 
tested by a CPSC-accepted third party conformity assessment body and 
demonstrate compliance with all applicable CPSC requirements for the 
manufacturer to issue a Children's Product Certificate (``CPC'') before 
the toys can be entered into commerce.
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    \1\ ASTM F963-11 is a consumer product safety standard, except 
for section 4.2 and Annex 4, or any provision that restates or 
incorporates an existing mandatory standard or ban promulgated by 
the Commission or by statute.
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    The toy standard has numerous requirements. Among them, section 
4.3.5 requires that surface coating materials and accessible substrates 
of toys \2\ that can be sucked, mouthed, or

[[Page 78652]]

ingested, comply with the solubility limits on eight heavy elements. 
(We refer to these elements as the ``ASTM heavy elements.'') One of the 
eight ASTM heavy elements is lead. The Commission previously determined 
that certain materials do not exceed the lead content limit, and 
therefore, those materials do not require third party testing when used 
in children's products (including toys). 16 CFR 1500.91. Thus, CPSC 
staff focused its work on the remaining seven ASTM heavy elements. The 
eight ASTM heavy elements and their solubility limits are shown below.
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    \2\ ASTM F963-11 contains the following note regarding the scope 
of the solubility requirement:
    NOTE 3--For the purposes of this requirement, the following 
criteria are considered reasonably appropriate for the 
classification of toys or parts likely to be sucked, mouthed or 
ingested: (1) All toy parts intended to be mouthed or contact food 
or drink, components of toys which are cosmetics, and components of 
writing instruments categorized as toys; (2) Toys intended for 
children less than 6 years of age, that is, all accessible parts and 
components where there is a probability that those parts and 
components may come into contact with the mouth.
    \3\ The method to assess the solubility of a listed element is 
detailed in section 8.3.2, Method to Dissolve Soluble Matter for 
Surface Coatings, of ASTM F963-11. Modeling clays included as part 
of a toy have different solubility limits for several of the 
elements.

   Table 1--Maximum Soluble Migrated Element in Parts-per-Million for
        Surface Coatings and Substrates Included as Part of a Toy
------------------------------------------------------------------------
                                                            Solubility
                                                           limit, parts
                         Element                           per million,
                                                           (``ppm'') \3\
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Antimony, (``Sb'')......................................              60
Arsenic, (``As'').......................................              25
Barium, (``Ba'')........................................            1000
Cadmium, (``Cd'').......................................              75
Chromium, (``Cr'')......................................              60
Lead, (``Pb'')..........................................              90
Mercury, (``Hg'').......................................              60
Selenium, (``Se'')......................................             500
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3. Possible Determinations Regarding the ASTM Heavy Elements

    For some materials, the concentrations of all the listed heavy 
elements might always be below their respective solubility limits due 
to biological, manufacturing, or other constraints. For example, one of 
the specified elements may be sequestered in a portion of a plant, such 
as the roots, that is not used in subsequent manufacturing. 
Additionally, a manufacturing process step may remove a specified 
element, if the element is present, from the material being processed. 
For these materials, compliance with the limits stated in section 4.3.5 
of ASTM F963-11 is assured without requiring third party testing 
because the material is intrinsically compliant.
    The third party testing burden could only be reduced if all heavy 
elements listed in section 4.3.5 have concentrations below their 
solubility limits. Because third party conformity assessment bodies 
typically run one test for all of the ASTM heavy elements, no testing 
burden reduction would be achieved if any one of the heavy elements 
requires testing.
    As discussed further in this preamble, if the Commission determines 
that, due to the nature of a particular material, children's products 
made of that material will comply with CPSC's requirements with a high 
degree of assurance, manufacturers do not need to have those materials 
tested by a third party conformity assessment body.

4. Direct Final Rule and Notice of Proposed Rulemaking

    On July 17, 2015, the Commission published a direct final rule 
(``DFR'') and a companion notice of proposed rulemaking (``NPR'') for 
the ASTM wood determination that is the subject of this final rule in 
the same issue of the Federal Register. (DFR, 80 FR 42376; NPR, 80 FR 
42438). Because the Commission received significant adverse comment to 
the DFR, the Commission withdrew the DFR and is proceeding with the 
rulemaking under the NPR that was published simultaneously with the 
DFR. 80 FR 54417 (Sept. 10, 2015). The comments to the DFR/NPR are 
addressed in section C of this preamble.

B. Contractor's Research

1. Overview

    CPSC hired a contractor to conduct a literature search to assess 
whether the Commission potentially could determine that wood and other 
natural materials do not contain any of the seven specified heavy 
elements in concentrations above the ASTM F963-11 maximum solubility 
limits (excluding the eighth element, lead which is already subject to 
a determination). The contractor researched the following materials:
     Unfinished and untreated wood (ash, beech, birch, cherry, 
maple, oak, pine, poplar, and walnut);
     Bamboo;
     Beeswax;
     Undyed and untreated fibers and textiles (cotton, wool, 
linen, and silk); and
     Uncoated or coated paper (wood or other cellulosic fiber). 
Staff chose these materials for research because they met two criteria:
     Materials the Commission previously determined not to 
contain lead in concentrations above 100 ppm; and
     Materials more likely to be used in toys subject to the 
ASTM F963-11 solubility limits.
    The contractor's report is available on the Commission's Web site 
at: http://www.cpsc.gov//Global/Research-and-Statistics/Technical-Reports/Toys/TERAReportASTMElements.pdf. CPSC staff reviewed the 
contractor's report and prepared a briefing package providing 
recommendations to the Commission. The staff's briefing package is also 
available on the Commission's Web site: http://www.cpsc.gov//Global/Newsroom/FOIA/CommissionBriefingPackages/2015/DFRandNPRDeterminationsontheASTMElementsUnfinishedWoods%20June302015.pdf
.
    In conducting this research, the contractor considered the 
following factors:
     The concentrations of the seven heavy elements in the 
material under study;
     The presence and concentrations of the elements in the 
environmental media (e.g., soil, water, air), and in the base materials 
for the textiles and paper;
     Whether processing has the potential to introduce any of 
the seven heavy elements into the material under study; and
     The potential for contamination after production, such as 
through packaging.
    The contractor examined secondary sources and reviewed articles to 
identify the available data regarding the elements' concentrations in 
the materials listed above. The contractor summarized the relevant data 
on bioavailability and presence/concentrations in environmental media 
(i.e., soil, air, and water) from the most recent Agency for Toxic 
Substances and Disease Registry (``ATSDR'') \4\ toxicological profile, 
supplemented with more recent authoritative reviews. The contractor 
conducted a literature search for data on concentrations of the 
chemical elements in each of the specific materials. Potentially 
relevant papers for information on concentrations of chemical elements 
in each product were identified and reviewed. The contractor used the 
references from reviewed articles to

[[Page 78653]]

identify other articles to examine and used the references in those 
articles to find other sources recursively, to uncover relevant cited 
references.\5\ The literature screening was to examine whether there is 
a potential for an ASTM heavy element to be present in the natural 
material at levels above its solubility limit. When the contractor 
determined there was sufficient information to indicate the potential 
for an ASTM heavy element to be present, the contractor stopped that 
particular line of inquiry and reported the results.
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    \4\ The congressionally mandated Agency for Toxic Substances and 
Disease Registry produces toxicological profiles for hazardous 
substances found at National Priorities List sites.
    \5\ `This method is often referred to as ``tree searching.''
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    As discussed in the staff's briefing package, the contractor's 
report does not support a Commission determination for any material 
other than unfinished and untreated trunk wood. The literature reviewed 
by the contractor did not provide sufficient information to determine 
that any of the reviewed materials, other than unfinished and untreated 
trunk wood, do not contain the heavy elements in concentrations above 
the limits stated in the toy standard.

2. Findings Regarding Wood

    Of the materials reviewed, the contractor identified the most 
studies for wood. Although the contractor could not examine every study 
concerning wood, the contractor reported that the studies examined 
constitute a representative sample of the population studies. The 
contractor studied measurements taken from trees in natural settings, 
samples from trees grown on contaminated soils, hydroponically grown 
\6\ seedlings, experimental studies with seedlings grown in pots in 
which the soil had some of the elements intentionally added, and 
seedlings soaked in solutions containing one or more of the ASTM heavy 
elements.
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    \6\ Hydroponics is a subset of hydroculture and is a method of 
growing plants using mineral nutrient solutions, in water, without 
soil.
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    The contractor examined measurements on roots, shoots, bark, 
trunks, branches, and leaves (or needles, for evergreens). Not every 
study conducted measurements on each part of the tree. Many studies 
showed concentrations of the ASTM heavy elements at levels below their 
solubility limits.
    Antimony. For antimony, the studies examined showed that roots, 
shoots, branches, and leaves contained antimony in concentrations 
greater than the ASTM solubility limit of 60 ppm. No tree trunks showed 
antimony concentrations above the ASTM solubility limit. One study's 
measurements of tree trunks showed that the trunks were nearly free of 
antimony.
    Arsenic. For arsenic, trunks, roots shoots, leaves, stems, bark, 
and branches of trees were characterized. An experimental study showed 
roots with more than 25 ppm arsenic. A study at a contaminated mining 
site showed roots, branches, leaves/needles, and shoots with arsenic 
concentrations above the ASTM solubility limit. However, no tree trunk 
measurement showed arsenic in concentrations above 25 ppm. In the two 
tested cases, tree trunks contained only trace levels of arsenic 
(levels well below the solubility limit).
    One study measured levels of arsenic in sawdust sampled from 15 
sawmill locations in the Sapele metropolis (a port city in Nigeria). 
The highest arsenic concentration measured was 93.0 ppm. The study's 
authors did not specify what types of trees or wood were processed at 
the sawmills. However, the authors noted that a major industry in the 
study area is Africa Timber Plywood Industry and mentioned that arsenic 
and chromium are used as wood preservatives. Plywood is a manufactured 
wood and could contain materials not found in natural wood. The authors 
did not report what woods these sawmills were processing. Therefore, we 
cannot draw any conclusions from this study.
    Barium. For barium, measurements of leaves, leaf litter, wood, and 
sawdust all showed barium concentrations below the ASTM solubility 
limit of 1,000 ppm.
    Cadmium. For cadmium, the studies examined showed cadmium in tree 
core samples and wood at levels below the ASTM solubility limit of 75 
ppm. Studies that measured cadmium in hydroponic samples showed cadmium 
levels in root, stem bark, stem wood, and leaf parts above 75 ppm. In a 
similar manner, shoots grown in pots containing varying amounts of 
cadmium added, showed cadmium concentrations above the ASTM solubility 
limit in leaves, stems, and roots.
    Chromium. For chromium, one study at a chromate-contaminated site 
found chromium concentrations above the ASTM solubility limit of 60 ppm 
in roots, but measurements were below the detection limit for leaves, 
wood, and bark. Hydroponic studies by the same researcher showed that 
tree roots can concentrate chromium, but translocation (the movement of 
a material from one place to another) of chromium from the roots to 
other parts of the tree, is very low.
    Mercury. For mercury, the contractor reviewed studies that measured 
mercury uptake in the roots, shoots, leaves, bark, trunks, limbs, 
fruits, branches, stems, and nuts of trees. The studies included both 
experimental tests and trees sampled from natural areas. Only an 
experimental study with seedlings grown in pots, to which either 
mercuric nitrate, methyl mercury chloride, or both, had been added, 
showed mercury in concentrations above the ASTM solubility limit in 
shoots and leaves of sycamore seedlings. The other studies did not show 
mercury levels above the ASTM solubility limit of 60 ppm in samples, 
even at contaminated sites.
    Selenium. For selenium, one study showed measured concentrations of 
1.4 ppm selenium in tree rings growing in contaminated soil. Other 
studies showed selenium at concentrations of 10 ppm or less, well below 
the ASTM solubility limit of 500 ppm. Only an experimental study with 
tree cuttings grown hydroponically in either sodium selenate or sodium 
selenite for 6 days, showed root concentrations above the ASTM 
solubility limit. All other parts of the cuttings had selenium levels 
below the ASTM solubility limit.
    Conclusions. The contractor's report provides sufficient 
information for the Commission to determine that unfinished and 
untreated wood from tree trunks does not contain the ASTM heavy 
elements in concentrations above their respective solubility limits, 
and are, therefore, not required to be third party tested to assure 
compliance with the ASTM F963-11 solubility requirements. The studies 
examined multiple species of trees grown on several continents. No 
study examined by the contractor found any of the ASTM heavy elements 
in tree trunks at concentrations beyond the element's solubility limit.
    The contractor's report indicates that heavy elements could be 
present in wood from other portions of the tree: The roots, bark, 
leaves, or fruit. The studies examined by the contractor showed high 
levels of one or more of the ASTM heavy elements in portions of trees 
other than trunks. However, commercial timber harvesting involves the 
process of ``delimbing'' the tree to create logs that can be 
transported and cut at a sawmill or lumberyard.\7\ Often, the sawmill 
creates uniform-length planks from the delivered logs. These

[[Page 78654]]

planks are sold to wood wholesalers or retailers, and are bought by 
wooden toy and other manufacturers. Because commercial practice creates 
logs from only the trunks of harvested trees, the wood available for 
use in toys and other wooden objects is sourced from these logs, or 
trunks of trees, and not the other parts of trees that could contain 
the ASTM elements above the limits in the toy standard.\8\
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    \7\ A succinct description of timber logging can be found at 
http://en.wikipedia.org/w/index.php?title=Logging&redirect=no. A 
more comprehensive review of timber harvesting can be found at 
http://www.amazon.com/Tree-Harvesting-Techniques-Forestry-Sciences/dp/9048182824/ref=sr_1_1?s=books&ie=UTF8&qid=1433193105&sr=1-1&keywords=tree+harvesting+techniques%2C+wiksten.
    \8\ Often, the sawmill creates uniform-length planks from the 
delivered logs. These planks are sold to wood wholesalers or 
retailers, and are bought by wooden toy and other manufacturers. Two 
references to the woods used in toys are: http://www.ehow.com/list_6896897_kinds-wood-toys-made-from_.html, and http://www.woodtoyz.com/WTCat/LearnMaterials.html.
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C. Discussion of Comments to the DFR/NPR

    The CPSC received six comments in response to the DFR and NPR 
published in the Federal Register on July 17, 2015 (80 FR 42376). 
Summaries of each comment and our responses are provided below.
    Three comments express support for the proposed determination that 
unfinished and untreated wood from tree trunks does not require testing 
for the ASTM elements. Two comments raise questions and requested 
clarification about the rule. One comment expresses opposition to 
exempting wood toys from testing.
    Comment 1: One commenter asks what safety measures would be 
implemented to prevent manufactures from using treated wood instead of 
untreated wood in toys, and asks what would be classified as untreated 
wood. For example, the commenter asks if a clear sealant could be used 
to protect the wood from water and saliva and still be considered 
untreated wood.
    The commenter also asks what penalties would be incurred if treated 
wood was used in children's toys.
    Response 1: The proposed rule does not prohibit the use of wood 
finishes or treatments in children's products. There is no penalty for 
using treated woods in children's toys as long as the treatment does 
not violate an applicable children's product safety rule. The purpose 
of the rule is for the Commission to determine that unfinished and 
untreated wood does not contain the chemical elements that are 
restricted in toys under the mandatory toy standard, and thus 
unfinished and untreated wood does not require third party testing to 
ensure compliance to the toy standard's chemical solubility 
requirement. The effect of the rule would be to relieve manufacturers 
and importers of the third party testing requirement for children's 
products for unfinished and untreated wood toys or wood component parts 
of toys.
    A surface coating, such as a clear sealant applied to unfinished 
wood, is subject to the requirements of 16 CFR part 1303 and the toy 
standard's chemical solubility requirement. The manufacturer would need 
to third party test the finished product or could use component part 
testing to test only the surface coating pursuant to 16 CFR part 1109.
    Comment 2: A commenter asserts that testing still should be 
required for untreated wood because ``so many toys are filled with 
other chemicals which will be inserted into the mouths of millions of 
children.'' The commenter asserts that much of the wood from outside 
the United States could be contaminated by heavy metals during 
processing or before shipping. This commenter also states that the 
required testing is a simple step to ensure the safety of toys.
    Response 2: The commenter does not provide any data or specific 
information about toys ``filled with other chemicals'' that would 
support a testing requirement for unfinished and untreated wood subject 
to the ASTM elements restrictions. Nor does the commenter dispute the 
data and information relied upon by the Commission. The determination 
for unfinished and untreated wood is based on data and information 
about the chemical content of wood from all over the world that 
demonstrated that unfinished and untreated wood does not contain the 
chemical elements that are restricted in toys under the toy standard. 
We note that the only chemicals specifically prohibited in toys by ASTM 
F963 are lead and the seven other ASTM elements; in addition, the CPSIA 
prohibited specified phthalates.
    Although the commenter refers to the ``simple step'' of testing, 
mandatory third party testing can be costly, especially for small or 
low-volume suppliers. The determination responds to the statutory 
requirement to consider new or revised third party testing requirements 
that will reduce third party testing costs consistent with assuring 
compliance with the applicable consumer product safety rules, bans, 
standards, and regulations.
    Comment 3: A commenter states that his or her understanding of the 
proposed rule is that ``any untreated wooden toy [could] be tested at 
any 3rd party lab, not [only those] accredited by the CPSC.'' Based on 
this commenter's understanding of the rule, the commenter asks whether 
other required ASTM F963 tests on natural wood toys, such as for 
accessible edges and small parts, could be performed at any third party 
laboratory, not just laboratories accredited by the CPSC.
    Response 3: The rule affects only the testing requirement for 
compliance to the ASTM F963 chemical solubility limits. If a toy is 
subject to other ASTM F963 requirements, such as the mechanical 
requirements, compliance with those requirements still must be 
demonstrated through testing by a CPSC-accepted conformity assessment 
body for the manufacturer to issue a children's product certificate.
    Comment 4: A commenter asserts that the testing requirements are 
``overwhelming,'' and are a factor in reducing the number of specialty 
``single store, independent `mom and pop' stores.''
    The commenter urges passing a law that would establish that federal 
requirements would preempt state requirements that add to the burden 
for small companies, and further asserts that only the largest 
companies are able to meet the requirements.
    Response 4: The comment is beyond the scope of the current 
rulemaking. The proposed rule does not address state requirements or 
testing issues other than the determination for unfinished and 
untreated wood.
    Comment 5: One commenter, representing several consumer 
organizations, expresses support for the CPSC's detailed research and 
study on this issue and agrees that unfinished and untreated trunk wood 
can be exempted from compliance testing for the heavy elements of the 
toy standard without any impact on safety. This commenter also 
expresses support for the Commission's decision not to include in the 
proposed rule bamboo, beeswax, cotton, wool, linen, and silk, and 
states that not enough evidence has been presented for a determination 
on these materials.
    Response 5: The rule is based on data and information on the 
presence of the ASTM elements in unfinished and untreated wood and 
other natural materials. The information on bamboo, beeswax, linen, and 
silk was insufficient to make a Commission determination on these 
materials.
    Comment 6: A commenter states that the rule would provide limited 
relief to toy manufacturers because very few toy manufacturers are 
making products using wood, and wood toys constitute only a small 
percentage of the toys in the marketplace.
    The commenter urges the Commission to continue to find ways to 
provide meaningful third party testing burden reduction for companies 
and for

[[Page 78655]]

products most impacted by the testing requirements. The commenter 
suggests that one way for the Commission to do this is by reconsidering 
the parameters used to exclude materials from testing. The commenter 
states that the Commission's current standard for finding materials 
that could be exempt from testing is ``unreasonably high.'' In 
addition, the commenter claims Congress's intent was not for the CPSC 
to apply a ``near zero-risk-tolerance approach.'' The commenter 
references other Commission actions that ``allow for some level of risk 
tolerance,'' such as the component part testing rule at 16 CFR 
1109.5(b), which the commenter claims addresses the exercise of due 
care, and does not require certainty. Additionally, the commenter 
mentions the lead determination rule at 16 CFR 1500.91(b), pointing to 
text indicating that the rule is based on a finding that the material 
or product ``does not exceed'' the lead limits, not on a more onerous 
standard of ``will never exceed.''
    The commenter also points to the test procedures of the toy 
standard (i.e., testing is not conducted if only a small amount of 
material is present on the product), and urges the Commission to 
consider this de minimus approach, and approaches like it, to provide 
meaningful third party testing burden relief.
    Response 6: Public Law 112-28 requires that actions to reduce the 
costs associated with third party testing must be consistent with 
assuring compliance with any applicable consumer product safety rule, 
ban, standard, or regulation. This requirement establishes the standard 
for Commission decisions for implementing any actions to reduce the 
cost associated with third party testing.
    The rule on determinations for the ASTM elements in wood for 
products subject to the toy safety standard represents only one of 
several completed and ongoing Commission activities to implement, 
research, and pursue opportunities to reduce the cost of third party 
testing requirements.
    The commenter's recommendation to consider de minimus and other 
approaches to reduce third party testing costs are beyond the scope of 
this rulemaking.

D. Determination for Unfinished and Untreated Wood for ASTM F963 Limits 
for Heavy Elements

1. Legal Requirements for a Determination

    As noted above, section 14(a)(2) of the CPSA requires third party 
testing for children's products that are subject to a children's 
product safety rule. 15 U.S.C. 2063(a)(2). Toys must comply with the 
toy standard, including the specified limits on heavy elements. 15 
U.S.C. 2056b. In response to statutory direction, the Commission has 
investigated approaches that would reduce the burden of third party 
testing while also assuring compliance with CPSC requirements. As part 
of that endeavor, the Commission has considered whether certain 
materials used in toys would not require third party testing.
    To issue a determination that a material does not require third 
party testing, the Commission must have sufficient evidence to conclude 
that the material would consistently comply with the CPSC requirement 
that the material is subject to so that third party testing is 
unnecessary to provide a high degree of assurance of compliance. 16 CFR 
part 1107. Section 1107.2, defines ``a high degree of assurance'' as 
``an evidence-based demonstration of consistent performance of a 
product regarding compliance based on knowledge of a product and its 
manufacture.''
    For a material determination, a high degree of assurance of 
compliance means that the material will comply with the specified 
chemical limits due to the nature of the material, or due to a 
processing technique (e.g., harvesting, smelting, cleaning, filtering, 
sorting) that reduces the chemical concentration below its limit. For 
materials determined to comply with a chemical limit, the material must 
continue to comply with that limit if it is used in a children's 
product subject to that requirement. A material on which a 
determination has been made cannot be altered or adulterated to render 
it noncompliant and then used in a children's product.
    Based on the information discussed in section B of this preamble, 
the Commission determines that unfinished and untreated trunk wood 
complies with the solubility requirements for the heavy elements in 
section 4.3.5 of ASTM F963-11 with a high degree of assurance. This 
determination means that third party testing for compliance to the 
solubility requirements is not required for certification purposes for 
unfinished and untreated trunk wood. The Commission makes this 
determination to reduce the third party testing burden on children's 
product certifiers while continuing to ensure compliance.

2. Potential for Third Party Testing Burden Reduction

    CPSC staff assessed the burden reduction that could result from a 
determination that unfinished and untreated trunk wood does not require 
third party testing for compliance with the limits on heavy elements in 
the toy standards. Testing the soluble concentration of the ASTM heavy 
elements requires placing the toy (or component part of the toy) in a 
solution of hydrochloric acid for 2 hours. After 2 hours, the solids 
are separated from the solution, and the solution is analyzed for the 
presence of any of the ASTM F963-11 heavy elements using atomic 
spectroscopy. The cost of this testing can vary by factors such as 
geography and the volume of testing that a manufacturer obtains from a 
conformity assessment body. Based on published invoices and price 
lists, the cost of a third party test for the ASTM heavy elements 
ranges from around $60 in China, up to around $190 in the United 
States.
    Staff cannot estimate with any certainty what the total potential 
burden reduction would be from a determination that unfinished and 
untreated wood will not contain concentrations of antimony, arsenic, 
barium, cadmium, mercury, and selenium in excess of the limits in ASTM 
F963-11. Most of the approximately 80,000 kinds of toys on the market 
\9\ probably do not contain any wood components. If we assume that 10 
percent of the approximately 80,000 different kinds of toys on the 
market have at least one wood component that requires third party 
testing, and we also assume that the average cost of a third party test 
is about $125 (representing the approximate midpoint of the range for 
the test's cost), then the potential total burden reduction from a 
determination for unfinished and untreated wood from tree trunks would 
be about $1 million annually. This estimate assumes that only one type 
of wood was used in a product so that the manufacturer would not have 
to test each individual unfinished and untreated wood component part in 
a product, as allowed by the component part testing rule (16 CFR part 
1109). The estimated benefits

[[Page 78656]]

could be lower if some manufacturers certify that their wood components 
comply with the ASTM F963-11 heavy elements requirements, based on 
third party tests of their raw materials instead of the finished 
product, as allowed by the component part testing rule. Moreover, the 
assumption that 10 percent of the toys have wood components is intended 
only to illustrate the potential benefits; the assumption is not based 
on any formal study of the toy market.
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    \9\ The estimate that there are 80,000 different kinds of toys 
is based on the number of toys listed on the Amazon.com Web site on 
June 2, 2015, for which Amazon.com was listed as the seller and 
recommended for children 13 years old or younger. Examples of toys 
that might include wood components include building blocks, various 
wood pull toys, some toy cars and trucks, train sets, some games and 
puzzles, some toy figures, and some toys for toddlers and infants.
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3. Statutory Authority

    Section 3 of the CPSIA grants the Commission general rulemaking 
authority to issue regulations, as necessary, to implement the CPSIA. 
Public Law 110-314, sec. 3, Aug. 14, 2008. As noted previously, section 
14 of the CPSA, which was amended by the CPSIA, requires third party 
testing for children's products that are subject to a children's 
product safety rule. 15 U.S.C. 2063(a)(2). Section 14(d)(3)(B) of the 
CPSA, as amended by Public Law 112-28, gives the Commission the 
authority to ``prescribe new or revised third party testing regulations 
if it determines that such regulations will reduce third party testing 
costs consistent with assuring compliance with the applicable consumer 
product safety rules, bans, standards, and regulations.'' Id. 
2063(d)(3)(B). These statutory provisions authorize the Commission to 
issue this rule determining that unfinished and untreated trunk wood 
will not exceed the limits for heavy elements stated in the toy 
standard, and therefore, unfinished and untreated trunk wood does not 
require third party conformity assessment body testing to assure 
compliance with the heavy elements limits stated in the toy standard.
    This determination relieves unfinished and untreated trunk wood 
from the third party testing requirement of section 14 of the CPSA for 
purposes of supporting the required certification. However, if the 
unfinished and untreated wood is altered so that the material could 
exceed the heavy elements limits of ASTM F963, the determination is not 
applicable to that material. The changed or altered material or product 
must then be tested and meet the heavy element requirements of ASTM 
F963.
    The determination only lifts the obligation to have unfinished and 
untreated trunk wood tested by a third party conformity assessment 
body. The underlying requirement that products subject to the toy 
standard must comply with the toy standard's limits on heavy elements 
remains in place.

4. Description of the Rule

    This rule creates a new Part 1251 for ``Toys: Determination 
Regarding Heavy Elements Limits for Unfinished and Untreated Wood.'' 
Section 1251.1 of the rule explains the statutorily-created 
requirements for toys under ASTM F963 and the third party testing 
requirements for children's products.
    Section 1251.2(a) of the rule establishes the Commission's 
determination that unfinished and untreated trunk wood does not exceed 
the limits for the heavy elements established in section 4.3.5 of the 
toy standard with a high degree of assurance as that term is defined in 
16 CFR part 1107. The determination only applies if the material has 
not been treated or adulterated with the addition of any materials that 
could result in the addition of any of the heavy elements listed in the 
toy standard at levels above their respective solubility limits. In 
Sec.  1251.2(b) of the rule, unfinished and untreated trunk wood means 
wood harvested from trees with no added surface coatings (e.g., 
varnish, paint, shellac, polyurethane) and no materials added to the 
wood substrate (e.g., stains, dyes, preservatives, antifungals, 
insecticides). Because commercial practice creates wood from only the 
trunks of harvested trees, unfinished and untreated wood as used in the 
rule means wood that is generally commercially available. Unfinished 
and untreated wood does not include manufactured or engineered woods 
such as pressed wood, plywood, particle board, or fiberboard.

E. Effective Date

    The APA generally requires that a substantive rule must be 
published not less than 30 days before its effective date. 5 U.S.C. 
553(d)(1). Because the final rule provides relief from existing testing 
requirements under the CPSIA, the effective date is January 19, 2016.

F. Regulatory Flexibility Act

    The Regulatory Flexibility Act (``RFA'') generally requires that 
agencies review proposed and final rules for the rules' potential 
economic impact on small entities, including small businesses, and 
prepare regulatory flexibility analyses. 5 U.S.C. 603 and 604. The 
Commission certified that this rule will not have a significant impact 
on a substantial number of small entities pursuant to section 605(b) of 
the RFA, 5 U.S.C. 605(b) in the DFR. 80 FR 42376, 42380. The Commission 
did not receive any comments that questioned or challenged this 
certification, nor has CPSC staff received any other information that 
would require a change or revision to the Commission's previous 
analysis of the impact of the rule on small entities. Therefore, the 
certification of no significant impact on a substantial number of small 
entities is still appropriate.

G. Environmental Considerations

    The Commission's regulations provide a categorical exclusion for 
Commission rules from any requirement to prepare an environmental 
assessment or an environmental impact statement because they ``have 
little or no potential for affecting the human environment.'' 16 CFR 
1021.5(c)(2). This rule falls within the categorical exclusion, so no 
environmental assessment or environmental impact statement is required. 
The Commission's regulations state that safety standards for products 
normally have little or no potential for affecting the human 
environment. 16 CFR 1021.5(c)(1). Nothing in this rule alters that 
expectation.

List of Subjects in 16 CFR Part 1251

    Business and industry, Consumer protection, Imports, Infants and 
children, Product testing and certification, Toys.

    Accordingly, 16 CFR part 1251 is added to read as follows:

PART 1251--TOYS: DETERMINATIONS REGARDING HEAVY ELEMENTS LIMITS FOR 
CERTAIN MATERIALS

Sec.
1251.1 The toy standard and testing requirements.
1251.2 Wood.


    Authority: Sec. 3, Pub. L. 110-314, 122 Stat. 3016; 15 U.S.C. 
2063(d)(3)(B).


Sec.  1251.1  The toy standard and testing requirements.

    The Consumer Product Safety Improvement Act of 2008 (``CPSIA'') 
made provisions of ASTM F963, Consumer Product Safety Specifications 
for Toy Safety (``toy standard''), a mandatory consumer product safety 
standard. 15 U.S.C. 2056b. The toy standard requires that surface 
coating materials and accessible substrates of toys that can be sucked, 
mouthed, or ingested, must comply with solubility limits that the toy 
standard establishes for eight heavy elements. Materials used in toys 
subject to the heavy elements limits in the toy standard must comply 
with the third party testing requirements of section 14(a)(2) of the 
Consumer Product Safety Act (``CPSA''), unless listed in Sec.  1251.2.

[[Page 78657]]

Sec.  1251.2  Wood.

    (a) Unfinished and untreated wood does not exceed the limits for 
the heavy elements established in the toy standard with a high degree 
of assurance as that term is defined in 16 CFR part 1107, provided that 
the material has been neither treated nor adulterated with materials 
that could result in the addition of any of the heavy elements listed 
in the toy standard at levels above their respective solubility limits.
    (b) For purposes of this section, unfinished and untreated wood 
means wood harvested from the trunks of trees with no added surface 
coatings (such as, varnish, paint, shellac, or polyurethane) and no 
materials added to the wood substrate (such as, stains, dyes, 
preservatives, antifungals, or insecticides). Unfinished and untreated 
wood does not include manufactured or engineered woods (such as pressed 
wood, plywood, particle board, or fiberboard).

    Dated: December 9, 2015.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2015-31723 Filed 12-16-15; 8:45 am]
BILLING CODE 6355-01-P