Toys: Determination Regarding Heavy Elements Limits for Unfinished and Untreated Wood, 78651-78657 [2015-31723]
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Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Rules and Regulations
PAH for new parts that will be installed
in articles for which a dual
airworthiness release is to be issued. In
order to serve European customers
many U.S. repair stations will be
required to possess parts documentation
that U.S. PAHs cannot currently issue
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Although the FAA and EASA have
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Change 5 to the MAG until March 29,
2016, correcting the effective date of
§ 21.137(o) will provide PAHs with the
ability to establish a system for the
issuance of authorized release
documents to meet EASA requirements
without increasing staff in the form of
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Additionally, correcting the effective
date of §§ 21.142, 21.147, and 45.11(c)
will alleviate the current need for PAHs
to request new exemptions or renew
current exemptions to manufacture and
install interface components and
appropriately mark wooden propellers.
The remaining sections of the final
rule become effective on March 29,
2016, its originally published effective
date.
Correction
In FR Doc. 2015–24950, beginning on
page 59021 in the Federal Register of
October 1, 2015, in the second column,
correct the DATES section to read as
follows:
DATES: This final rule is effective
March 29, 2016, except for §§ 21.1(b)(1),
21.1(b)(5) through (9), 21.137(o), 21.142,
21.147 and 45.11(c), which are effective
on January 4, 2016.
Issued under authority provided by 49
U.S.C. 106(f), 44701(a), and 44703 in
Washington, DC, on December 11, 2015.
Lirio Liu,
Director, Office of Rulemaking.
[FR Doc. 2015–31639 Filed 12–16–15; 8:45 am]
BILLING CODE P
DEPARTMENT OF COMMERCE
658, in § 762.1, in paragraph (b), remove
‘‘§ 762.7’’ and add ‘‘§ 762.2’’ in its place,
and remove ‘‘§ 762.6’’ and add ‘‘§ 762.7’’
in its place.
[FR Doc. 2015–31733 Filed 12–16–15; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF COMMERCE
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15 CFR Part 772
Definitions of Terms
CFR Correction
In Title 15 of the Code of Federal
Regulations, Parts 300 to 799, revised as
of January 1, 2015, on pages 723, 727,
and 733, in § 772.1, remove the
definitions of ‘‘fault tolerance’’, ‘‘laser
duration’’ and ‘‘positioning accuracy’’.
[FR Doc. 2015–31737 Filed 12–16–15; 8:45 am]
BILLING CODE 1505–01–D
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1251
[Docket No. CPSC–2011–0081]
Toys: Determination Regarding Heavy
Elements Limits for Unfinished and
Untreated Wood
U.S. Consumer Product Safety
Commission.
AGENCY:
ACTION:
Final rule.
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.
SUMMARY:
The rule is effective on January
19, 2016.
DATES:
Bureau of Industry and Security
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: jboja@
cpsc.gov.
FOR FURTHER INFORMATION CONTACT:
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15 CFR Part 762
Recordkeeping
CFR Correction
In Title 15 of the Code of Federal
Regulations, Parts 300 to 799, revised as
of January 1, 2015, on pages 657 and
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SUPPLEMENTARY INFORMATION:
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78651
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 CPSCenforced 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.
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
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.
2 ASTM F963–11 contains the following note
regarding the scope of the solubility requirement:
Continued
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Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Rules and Regulations
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.
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,
TABLE 1—MAXIMUM SOLUBLE MIchildren’s products made of that
GRATED ELEMENT IN PARTS-PER- material will comply with CPSC’s
MILLION FOR SURFACE COATINGS requirements with a high degree of
AND SUBSTRATES INCLUDED AS assurance, manufacturers do not need to
have those materials tested by a third
PART OF A TOY
party conformity assessment body.
Element
Antimony, (‘‘Sb’’) ...................
Arsenic, (‘‘As’’) ......................
Barium, (‘‘Ba’’) ......................
Cadmium, (‘‘Cd’’) ..................
Chromium, (‘‘Cr’’) ..................
Lead, (‘‘Pb’’) ..........................
Mercury, (‘‘Hg’’) ....................
Selenium, (‘‘Se’’) ...................
Solubility limit,
parts per
million,
(‘‘ppm’’) 3
60
25
1000
75
60
90
60
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
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.
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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
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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: https://
www.cpsc.gov//Global/Research-andStatistics/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: https://
www.cpsc.gov//Global/Newsroom/
FOIA/CommissionBriefingPackages/
2015/DFRandNPRDeterminationsonthe
ASTMElementsUnfinishedWoods%20
June302015.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
4 The congressionally mandated Agency for Toxic
Substances and Disease Registry produces
toxicological profiles for hazardous substances
found at National Priorities List sites.
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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.
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.
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
5 ‘This method is often referred to as ‘‘tree
searching.’’
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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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
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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
7 A succinct description of timber logging can be
found at https://en.wikipedia.org/w/index.php?
title=Logging&redirect=no. A more comprehensive
review of timber harvesting can be found at
https://www.amazon.com/Tree-HarvestingTechniques-Forestry-Sciences/dp/9048182824/
ref=sr_1_1?s=books&
ie=UTF8&qid=1433193105&sr=1-1&keywords=tree+
harvesting+techniques%2C+wiksten.
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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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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
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:
https://www.ehow.com/list_6896897_kinds-woodtoys-made-from_.html, and https://
www.woodtoyz.com/WTCat/LearnMaterials.html.
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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,
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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
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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
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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.
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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
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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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.
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.
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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
§ 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
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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).
§ 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 § 1251.2.
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Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Rules and Regulations
§ 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).
document corrects the final rule by
removing this paragraph.
DATES: Effective December 17, 2015.
FOR FURTHER INFORMATION CONTACT: John
R. Scherbenske, Office of Diversion
Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152, Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION: In FR Doc.
2015–28718 appearing on page 69864 in
the Federal Register of Thursday,
November 12, 2015, the following
correction is made:
Administrative Procedure Act
[Corrected]
1. On page 69864, in the preamble, at
the bottom of the first and top of the
second columns, the section titled
Administrative Procedure Act is
removed entirely.
Dated: December 11, 2015.
Chuck Rosenberg,
Acting Administrator.
Dated: December 9, 2015.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2015–31843 Filed 12–16–15; 8:45 am]
[FR Doc. 2015–31723 Filed 12–16–15; 8:45 am]
DEPARTMENT OF THE INTERIOR
BILLING CODE 4410–09–P
BILLING CODE 6355–01–P
Office of Surface Mining Reclamation
and Enforcement
DEPARTMENT OF JUSTICE
30 CFR Part 925
Drug Enforcement Administration
[SATS No. MO–041–FOR; Docket ID: OSM–
2013–0008; S1D1S SS08011000 SX064A000
167S180110; S2D2S SS08011000
SX064A000 16XS501520]
21 CFR Part 1308
[Docket No. DEA–419F]
Missouri Regulatory Program
Schedules of Controlled Substances:
Placement of Eluxadoline Into
Schedule IV; Correction
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule; correction.
AGENCY:
The Drug Enforcement
Administration (DEA) is correcting a
final rule that appeared in the Federal
Register of November 12, 2015 (80 FR
69861). The document issued an action
placing the substance 5-[[[(2S)-2-amino3-[4-aminocarbonyl)-2,6dimethylphenyl]-1-oxopropyl][(1S)-1-(4phenyl-1H-imidazol-2yl)ethyl]amino]methyl]-2methoxybenzoic acid (eluxadoline),
including its salts, isomers, and salts of
isomers, into schedule IV of the
Controlled Substances Act. This
document inadvertently included a
paragraph in the regulatory text that was
not intended for publication, and was
unable to be removed before being
placed on public inspection. This
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SUMMARY:
VerDate Sep<11>2014
15:06 Dec 16, 2015
Jkt 238001
Office of Surface Mining
Reclamation and Enforcement, Interior.
ACTION: Final rule; approval of
amendment.
AGENCY:
We, the Office of Surface
Mining Reclamation and Enforcement
(OSMRE), are approving an amendment
to the Missouri regulatory program
(Missouri program) under the Surface
Mining Control and Reclamation Act of
1977 (SMCRA or the Act). Missouri
proposed revisions to its regulations
concerning several topics regarding:
Valid Existing Rights; Protection of
Hydrologic Balance; Post-mining Land
Use; Permit Applications; and Air
Resource Protection. Missouri intends to
revise its program to be no less effective
than the Federal regulations, to clarify
ambiguities, and to improve operational
efficiency.
DATES: Effective Date: December 17,
2015.
FOR FURTHER INFORMATION CONTACT: Len
Meier, Director Alton Field Division,
SUMMARY:
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78657
Office of Surface Mining Reclamation
and Enforcement, 501 Belle Street, Suite
216, Alton, IL 62002, Telephone: (618)
463–6460, Email: lmeier@osmre.gov.
SUPPLEMENTARY INFORMATION:
I. Background on the Missouri Program
II. Submission of the Amendment
III. OSMRE’s Findings
IV. Summary and Disposition of Comments
V. OSMRE’s Decision
VI. Procedural Determinations
I. Background on the Missouri Program
Section 503(a) of the Act permits a
State to assume primacy for the
regulation of surface coal mining and
reclamation operations on non-Federal
and non-Indian lands within its borders
by demonstrating that its State program
includes, among other things, ‘‘a State
law which provides for the regulation of
surface coal mining and reclamation
operations in accordance with the
requirements of this Act . . .; and rules
and regulations consistent with
regulations issued by the Secretary
pursuant to this Act.’’ See 30 U.S.C.
1253(a)(1) and (7). On the basis of these
criteria, the Secretary of the Interior
conditionally approved the Missouri
program on November 21, 1980. You
can find background information on the
Missouri program, including the
Secretary’s findings, the disposition of
comments, and conditions of approval,
in the November 21, 1980, Federal
Register (45 FR 77017). You can find
later actions concerning the Missouri
program and program amendments at 30
CFR 925.10, 925.12, 925.15, and 925.16.
II. Submission of the Amendment
By letter dated August 12, 2013
(Administrative Record No. MO–678),
Missouri sent us an amendment to its
Program under SMCRA (30 U.S.C. 1201
et seq.). Missouri sent the amendment in
response to a January 31, 2008, letter
(Administrative Record No. MO–669)
we sent to Missouri in accordance with
30 CFR 732.17(c) concerning changes to
valid existing rights requirements.
Missouri also made changes to eliminate
required program amendments recorded
at 30 CFR 925.16(p)(4), (p)(20) and (v);
and program disapprovals at 30 CFR
925.12(d). Missouri revised other
sections of its regulations at its own
initiative. Missouri proposed revisions
to title 10 of its Code of State
Regulations (CSR) under Division 40
Land Reclamation Commission. The
specific sections of 10 CSR 40 in
Missouri’s amendment are discussed in
Part III OSMRE’s Findings. Missouri
intends to revise its program to be no
less effective than the Federal
regulations, to clarify ambiguities, and
improve operational efficiency.
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
jboja@cpsc.gov.
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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\
------------------------------------------------------------------------
Antimony, (``Sb'')...................................... 60
Arsenic, (``As'')....................................... 25
Barium, (``Ba'')........................................ 1000
Cadmium, (``Cd'')....................................... 75
Chromium, (``Cr'')...................................... 60
Lead, (``Pb'').......................................... 90
Mercury, (``Hg'')....................................... 60
Selenium, (``Se'')...................................... 500
------------------------------------------------------------------------
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: https://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: https://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.''
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\7\ A succinct description of timber logging can be found at
https://en.wikipedia.org/w/index.php?title=Logging&redirect=no. A
more comprehensive review of timber harvesting can be found at
https://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: https://www.ehow.com/list_6896897_kinds-wood-toys-made-from_.html, and https://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.
---------------------------------------------------------------------------
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
