80 FR 42376 - Toys: Determination Regarding Heavy Elements Limits for Unfinished and Untreated Wood

CONSUMER PRODUCT SAFETY COMMISSION

Federal Register Volume 80, Issue 137 (July 17, 2015)

Page Range		42376-42381
FR Document		2015-17413
The Consumer Product Safety Commission (``Commission,'' or ``CPSC'') is issuing a direct 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 wood in toys does not require third party testing for the heavy element limits in ASTM F963.
Federal Register, Volume 80 Issue 137 (Friday, July 17, 2015)
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Rules and Regulations]
[Pages 42376-42381]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17413]


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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: Direct final rule.

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SUMMARY: The Consumer Product Safety Commission (``Commission,'' or 
``CPSC'') is issuing a direct 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 wood in 
toys does not require third party testing for the heavy element limits 
in ASTM F963.

DATES: The rule is effective on September 15, 2015, unless we receive a 
significant adverse comment by August 17, 2015. If we receive a timely 
significant adverse comment, we will publish notification in the 
Federal Register, withdrawing this direct final rule before its 
effective date.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2011-
0081, by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: www.regulations.gov. Follow the instructions for 
submitting comments. The Commission does not accept comments submitted 
by electronic mail (email), except through www.regulations.gov. The 
Commission encourages you to submit electronic comments by using the 
Federal eRulemaking Portal, as described above.
    Written Submissions: Submit written submissions by mail/hand 
delivery/courier to: Office of the Secretary, Consumer Product Safety 
Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; 
telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this notice. All comments received may be posted 
without change, including any personal identifiers, contact 
information, or other personal information provided, to: 
www.regulations.gov. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
that you do not want to be available to the public. If furnished at 
all, such information should be submitted in writing.
    Docket: For access to the docket to read background documents or 
comments received, go to: www.regulations.gov, and insert the docket 
number CPSC-2011-0081, into the ``Search'' box, and follow the prompts.

FOR FURTHER INFORMATION CONTACT: Randy Butturini, Project Manager, 
Office of Hazard Identification and Reduction U.S. Consumer Product 
Safety Commission, 4330 East West Hwy, Room 814, Bethesda, MD 20814; 
301-504-7562: email; [email protected].

SUPPLEMENTARY INFORMATION:

A. Background

1. Third Party Testing

    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. Pub. L. 
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.'' In response to 
Pub. L. 112-28, the Commission published in the Federal Register a 
Request for Comment (``RFC''). See http://www.cpsc.gov//PageFiles/103251/3ptreduce.pdf. As directed by the Commission, staff submitted a 
briefing package to the Commission that described opportunities that 
the Commission

[[Page 42377]]

could pursue to potentially reduce the third party testing costs 
consistent with assuring compliance. See http://www.cpsc.gov/PageFiles/129398/reduce3pt.pdf.
    In addition to soliciting and reviewing comments as required by 
Pub. L. 112-28, the Commission published in the Federal Register on 
April 16, 2013 a Request for Information (``RFI'') on four potential 
opportunities to reduce testing burdens. See http://www.thefederalregister.org/fdsys/pkg/FR-2013-04-16/pdf/2013-08858.pdf. In February 2014, the Commission 
also published a notice in the Federal Register of a CPSC workshop on 
potential ways to reduce third party testing costs through 
determinations consistent with assuring compliance. See http://www.thefederalregister.org/fdsys/pkg/FR-2014-02-27/pdf/2014-04265.pdf. The workshop 
was held on April 3, 2014.
    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.

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 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 lead content limits, 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,
                          Element                             parts 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
------------------------------------------------------------------------

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 textile 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.

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

[[Page 42378]]

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 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 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 
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 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

[[Page 42379]]

their respective solubility limits, and are, therefore, not required to 
be third party tested to assure compliance with the ASTM F963-11 
solubility test. 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 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. 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 
testing laboratory. 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 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

[[Page 42380]]

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 exceeds 
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 
section 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.

D. Direct Final Rule Process

    The Commission is issuing this rule as a direct final rule 
(``DFR''). The Administrative Procedure Act (``APA'') generally 
requires notice and comment rulemaking 5 U.S.C. 553(b). In 
Recommendation 95-4, the Administrative Conference of the United States 
(``ACUS'') endorsed direct final rulemaking as an appropriate procedure 
to expedite promulgation of rules that are noncontroversial and that 
are not expected to generate significant adverse comment. See 60 FR 
43108 (August 18, 1995). Consistent with the ACUS recommendation, the 
Commission is publishing this rule as a direct final rule because we 
believe the determination will not be controversial. The rule will not 
impose any new obligations, but will relieve companies from the 
requirement of having toys (or materials that are component parts of 
toys) tested by a third party conformity assessment body if the toys or 
materials are made of unfinished and untreated wood. We expect that the 
determination will be supported by stakeholders. The determination 
responds to the desire expressed by numerous stakeholders and Congress 
that the Commission provide relief from the burdens of third party 
testing while also ensuring that products will comply with all 
applicable children's product safety rules. The rule establishes a 
discrete determination that a specific material (unfinished and 
untreated wood) in a particular type of product (toys) will always 
comply with the toy standard's limits on heavy elements. We expect that 
this focused action will not engender any significant adverse comments.
    Unless we receive a significant adverse comment within 30 days, the 
rule will become effective on September 15, 2015. In accordance with 
ACUS's recommendation, the Commission considers a significant adverse 
comment to be one where the commenter explains why the rule would be 
inappropriate, including an assertion challenging the rule's underlying 
premise or approach, or a claim that the rule would be ineffective or 
unacceptable without change.
    Should the Commission receive a significant adverse comment, the 
Commission will withdraw this direct final rule. A notice of proposed 
rulemaking (``NPR''), providing an opportunity for public comment, is 
also being published in this same issue of the Federal Register.

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 September 15, 2015. 
However, as discussed in section D of the preamble, if the Commission 
receives a significant adverse comment the Commission will withdraw the 
DFR and proceed with the NPR published in this same issue of the 
Federal Register.

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 rule would relieve toy manufacturers and importers of the 
responsibility of obtaining third party tests for compliance with the 
limits on the ASTM elements for components of toys consisting of 
unfinished and untreated wood. Although the impact will be to reduce 
testing costs, we expect that the rule would have only limited impact 
on toy manufacturers and importers for two reasons. First, the rule 
will affect only those companies that manufacture or import toys that 
contain unfinished and untreated wood components. We expect that 
relatively few of the approximately 80,000 toys on the market contain 
any unfinished and

[[Page 42381]]

untreated wood components. Therefore this rule would be expected to 
impact only a small number of manufacturers and importers or at most, a 
small portion of the toys in the market.
    Second, manufacturers of toys containing unfinished and untreated 
wood components still would be required to test to other aspects of the 
ASTM toy standard, so the impact of this rule relative to production 
costs for most firms should be small. Due to the small number of 
entities affected and the limited scope of the impact, the Commission 
certifies 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).

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

    Business and industry, Infants and children, Consumer protection, 
Imports, 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. Among the mandated provisions is section 4.3.5 of ASTM F963 
which 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 section 4.3.5 of 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.


Sec.  1251.2  Wood.

    (a) Unfinished and untreated 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, 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: July 13, 2015.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2015-17413 Filed 7-16-15; 8:45 am]
 BILLING CODE 6355-01-P
Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations 42379

their respective solubility limits, and CPSC requirements. As part of that of hydrochloric acid for 2 hours. After
are, therefore, not required to be third endeavor, the Commission has 2 hours, the solids are separated from
party tested to assure compliance with considered whether certain materials the solution, and the solution is
the ASTM F963–11 solubility test. The used in toys would not require third analyzed for the presence of any of the
studies examined multiple species of party testing. ASTM F963–11 heavy elements using
trees grown on several continents. No To issue a determination that a atomic spectroscopy. The cost of this
study examined by the contractor found material does not require third party testing can vary by factors such as
any of the ASTM heavy elements in tree testing, the Commission must have geography and the volume of testing
trunks at concentrations beyond the sufficient evidence to conclude that the that a manufacturer obtains from a
element’s solubility limit. material would consistently comply testing laboratory. Based on published
The contractor’s report indicates that with the CPSC requirement that the invoices and price lists, the cost of a
heavy elements could be present in material is subject to so that third party third party test for the ASTM heavy
wood from other portions of the tree: testing is unnecessary to provide a high elements ranges from around $60 in
The roots, bark, leaves, or fruit. The degree of assurance of compliance. 16 China, up to around $190 in the United
studies examined by the contractor CFR part 1107. Section 1107.2, defines States.
showed high levels of one or more of the ‘‘a high degree of assurance’’ as ‘‘an
ASTM heavy elements in portions of evidence-based demonstration of Staff cannot estimate with any
trees other than trunks. However, consistent performance of a product certainty what the total potential burden
commercial timber harvesting involves regarding compliance based on reduction would be from a
the process of ‘‘delimbing’’ The tree to knowledge of a product and its determination that unfinished and
create logs that can be transported and manufacture.’’ untreated wood will not contain
cut at a sawmill or lumberyard.7 Often, For a material determination, a high concentrations of antimony, arsenic,
the sawmill creates uniform-length degree of assurance of compliance barium, cadmium, mercury, and
planks from the delivered logs. These means that the material will comply selenium in excess of the limits in
planks are sold to wood wholesalers or with the specified chemical limits due ASTM F963–11. Most of the
retailers, and are bought by wooden toy to the nature of the material, or due to approximately 80,000 kinds of toys on
and other manufacturers. Because a processing technique (e.g., harvesting, the market 9 probably do not contain
commercial practice creates logs from smelting, cleaning, filtering, sorting) any wood components. If we assume
only the trunks of harvested trees, the that reduces the chemical concentration that 10 percent of the approximately
wood available for use in toys and other below its limit. For materials 80,000 different kinds of toys on the
wooden objects is sourced from these determined to comply with a chemical market have at least one wood
logs, or trunks of trees, and not the other limit, the material must continue to component that requires third party
parts of trees that could contain the comply with that limit if it is used in testing, and we also assume that the
ASTM elements above the limits in the a children’s product subject to that average cost of a third party test is about
toy standard.8 requirement. A material on which a $125 (representing the approximate
determination has been made cannot be midpoint of the range for the test’s cost),
C. Determination for Unfinished and altered or adulterated to render it
Untreated Wood for ASTM F963 Limits then the potential total burden
noncompliant and then used in a reduction from a determination for
for Heavy Elements children’s product. unfinished and untreated wood from
1. Legal Requirements for a Based on the information discussed in tree trunks would be about $1 million
Determination section B of this preamble, the annually. This estimate assumes that
As noted above, section 14(a)(2) of the Commission determines that unfinished only one type of wood was used in a
CPSA requires third party testing for and untreated trunk wood complies product so that the manufacturer would
children’s products that are subject to a with the solubility requirements for the not have to test each individual
children’s product safety rule. 15 U.S.C. heavy elements in section 4.3.5 of unfinished and untreated wood
2063(a)(2). Toys must comply with the ASTM F963–11 with a high degree of component part in a product, as allowed
toy standard, including the specified assurance. This determination means by the component part testing rule (16
limits on heavy elements. 15 U.S.C. that third party testing for compliance to CFR part 1109). The estimated benefits
2056b. In response to statutory the solubility requirements is not could be lower if some manufacturers
direction, the Commission has required for certification purposes for certify that their wood components
investigated approaches that would unfinished and untreated trunk wood. comply with the ASTM F963–11 heavy
reduce the burden of third party testing The Commission makes this elements requirements, based on third
while also assuring compliance with determination to reduce the third party party tests of their raw materials instead
testing burden on children’s product of the finished product, as allowed by
7 A succinct description of timber logging can be certifiers while continuing to ensure
the component part testing rule.
found at compliance.
http://en.wikipedia.org/w/index.php?title=
Moreover, the assumption that 10
Logging&redirect=no. A more comprehensive 2. Potential for Third Party Testing percent of the toys have wood
review of timber harvesting can be found at http:// Burden Reduction components is intended only to
www.amazon.com/Tree-Harvesting-Techniques- illustrate the potential benefits; the
Forestry-Sciences/dp/9048182824/ref=sr_1_1?s= CPSC staff assessed the burden
books&ie=UTF8&qid=1433193105&sr=1- reduction that could result from a
asabaliauskas on DSK5VPTVN1PROD with RULES

1&keywords=tree+harvesting+techniques determination that unfinished and 9 The estimate that there are 80,000 different

%2C+wiksten. kinds of toys is based on the number of toys listed
8 Often, the sawmill creates uniform-length
untreated trunk wood does not require on the Amazon.com Web site on June 2, 2015, for
planks from the delivered logs. These planks are third party testing for compliance with which Amazon.com was listed as the seller and
sold to wood wholesalers or retailers, and are the limits on heavy elements in the toy recommended for children 13 years old or younger.
bought by wooden toy and other manufacturers. standards. Testing the soluble Examples of toys that might include wood
Two references to the woods used in toys are: components include building blocks, various wood
http://www.ehow.com/list_6896897_kinds-wood-
concentration of the ASTM heavy pull toys, some toy cars and trucks, train sets, some
toys-made-from_.html, and http:// elements requires placing the toy (or games and puzzles, some toy figures, and some toys
www.woodtoyz.com/WTCat/LearnMaterials.html. component part of the toy) in a solution for toddlers and infants.

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42380 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations

assumption is not based on any formal determination that unfinished and particular type of product (toys) will
study of the toy market. untreated trunk wood does not exceed always comply with the toy standard’s
the limits for the heavy elements limits on heavy elements. We expect
3. Statutory Authority
established in section 4.3.5 of the toy that this focused action will not
Section 3 of the CPSIA grants the standard with a high degree of engender any significant adverse
Commission general rulemaking assurance as that term is defined in 16 comments.
authority to issue regulations, as CFR part 1107. The determination only Unless we receive a significant
necessary, to implement the CPSIA. applies if the material has not been adverse comment within 30 days, the
Public Law 110–314, § 3, Aug. 14, 2008. treated or adulterated with the addition rule will become effective on September
As noted previously, section 14 of the of any materials that could result in the 15, 2015. In accordance with ACUS’s
CPSA, which was amended by the addition of any of the heavy elements recommendation, the Commission
CPSIA, requires third party testing for listed in the toy standard at levels above considers a significant adverse comment
children’s products that are subject to a their respective solubility limits. In to be one where the commenter explains
children’s product safety rule. 15 U.S.C. section 1251.2(b) of the rule, unfinished why the rule would be inappropriate,
2063(a)(2). Section 14(d)(3)(B) of the and untreated trunk wood means wood including an assertion challenging the
CPSA, as amended by Public Law 112– harvested from trees with no added rule’s underlying premise or approach,
28, gives the Commission the authority surface coatings (e.g., varnish, paint, or a claim that the rule would be
to ‘‘prescribe new or revised third party shellac, polyurethane) and no materials ineffective or unacceptable without
testing regulations if it determines that added to the wood substrate (e.g., stains, change.
such regulations will reduce third party dyes, preservatives, antifungals, Should the Commission receive a
testing costs consistent with assuring insecticides). Because commercial significant adverse comment, the
compliance with the applicable practice creates wood from only the Commission will withdraw this direct
consumer product safety rules, bans, trunks of harvested trees, unfinished final rule. A notice of proposed
standards, and regulations.’’ Id. and untreated wood as used in the rule rulemaking (‘‘NPR’’), providing an
2063(d)(3)(B). These statutory means wood that is generally opportunity for public comment, is also
provisions authorize the Commission to commercially available. Unfinished and being published in this same issue of
issue this rule determining that untreated wood does not include the Federal Register.
unfinished and untreated trunk wood manufactured or engineered woods such E. Effective Date
will not exceed the limits for heavy as pressed wood, plywood, particle
elements stated in the toy standard, and board, or fiberboard. The APA generally requires that a
therefore, unfinished and untreated substantive rule must be published not
D. Direct Final Rule Process less than 30 days before its effective
trunk wood does not require third party
conformity assessment body testing to The Commission is issuing this rule date. 5 U.S.C. 553(d)(1). Because the
assure compliance with the heavy as a direct final rule (‘‘DFR’’). The final rule provides relief from existing
elements limits stated in the toy Administrative Procedure Act (‘‘APA’’) testing requirements under the CPSIA,
standard. generally requires notice and comment the effective date is September 15, 2015.
This determination relieves rulemaking 5 U.S.C. 553(b). In However, as discussed in section D of
unfinished and untreated trunk wood Recommendation 95–4, the the preamble, if the Commission
from the third party testing requirement Administrative Conference of the receives a significant adverse comment
of section 14 of the CPSA for purposes United States (‘‘ACUS’’) endorsed direct the Commission will withdraw the DFR
of supporting the required certification. final rulemaking as an appropriate and proceed with the NPR published in
However, if the unfinished and procedure to expedite promulgation of this same issue of the Federal Register.
untreated wood is altered so that the rules that are noncontroversial and that
are not expected to generate significant F. Regulatory Flexibility Act
material exceeds the heavy elements
limits of ASTM F963, the determination adverse comment. See 60 FR 43108 The Regulatory Flexibility Act
is not applicable to that material. The (August 18, 1995). Consistent with the (‘‘RFA’’) generally requires that agencies
changed or altered material or product ACUS recommendation, the review proposed and final rules for the
must then be tested and meet the heavy Commission is publishing this rule as a rules’ potential economic impact on
element requirements of ASTM F963. direct final rule because we believe the small entities, including small
The determination only lifts the determination will not be controversial. businesses, and prepare regulatory
obligation to have unfinished and The rule will not impose any new flexibility analyses. 5 U.S.C. 603 and
untreated trunk wood tested by a third obligations, but will relieve companies 604.
party conformity assessment body. The from the requirement of having toys (or The rule would relieve toy
underlying requirement that products materials that are component parts of manufacturers and importers of the
subject to the toy standard must comply toys) tested by a third party conformity responsibility of obtaining third party
with the toy standard’s limits on heavy assessment body if the toys or materials tests for compliance with the limits on
elements remains in place. are made of unfinished and untreated the ASTM elements for components of
wood. We expect that the determination toys consisting of unfinished and
4. Description of the Rule will be supported by stakeholders. The untreated wood. Although the impact
This rule creates a new Part 1251 for determination responds to the desire will be to reduce testing costs, we
‘‘Toys; Determination Regarding Heavy expressed by numerous stakeholders expect that the rule would have only
asabaliauskas on DSK5VPTVN1PROD with RULES

Elements Limits for Unfinished and and Congress that the Commission limited impact on toy manufacturers
Untreated Wood.’’ Section 1251.1 of the provide relief from the burdens of third and importers for two reasons. First, the
rule explains the statutorily-created party testing while also ensuring that rule will affect only those companies
requirements for toys under ASTM F963 products will comply with all that manufacture or import toys that
and the third party testing requirements applicable children’s product safety contain unfinished and untreated wood
for children’s products. rules. The rule establishes a discrete components. We expect that relatively
Section 1251.2(a) of the rule determination that a specific material few of the approximately 80,000 toys on
establishes the Commission’s (unfinished and untreated wood) in a the market contain any unfinished and

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Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Rules and Regulations 42381

untreated wood components. Therefore ingested, must comply with solubility Substances Act. This action is based on
this rule would be expected to impact limits that the toy standard establishes a finding by the Administrator that the
only a small number of manufacturers for eight heavy elements. Materials used placement of this opioid substance into
and importers or at most, a small in toys subject to section 4.3.5 of the toy schedule I of the Controlled Substances
portion of the toys in the market. standard must comply with the third Act is necessary to avoid an imminent
Second, manufacturers of toys party testing requirements of section hazard to the public safety. As a result
containing unfinished and untreated 14(a)(2) of the Consumer Product Safety of this order, the regulatory controls and
wood components still would be Act (‘‘CPSA’’), unless listed in § 1251.2. administrative, civil, and criminal
required to test to other aspects of the sanctions applicable to schedule I
ASTM toy standard, so the impact of § 1251.2 Wood. controlled substances will be imposed
this rule relative to production costs for (a) Unfinished and untreated wood on persons who handle (manufacture,
most firms should be small. Due to the does not exceed the limits for the heavy distribute, import, export, engage in
small number of entities affected and elements established in section 4.3.5 of research, or possess), or propose to
the limited scope of the impact, the the toy standard with a high degree of handle, acetyl fentanyl.
Commission certifies that this rule will assurance as that term is defined in 16 DATES: This final order is effective on
not have a significant impact on a CFR part 1107, provided that the July 17, 2015.
substantial number of small entities material has been neither treated nor
FOR FURTHER INFORMATION CONTACT: John
pursuant to section 605(b) of the RFA, adulterated with materials that could
5 U.S.C. 605(b). R. Scherbenske, Office of Diversion
result in the addition of any of the
Control, Drug Enforcement
G. Environmental Considerations heavy elements listed in the toy
Administration; Mailing Address: 8701
standard at levels above their respective
The Commission’s regulations Morrissette Drive, Springfield, Virginia
solubility limits.
provide a categorical exclusion for 22152, Telephone: (202) 598–6812.
(b) For purposes of this section,
Commission rules from any requirement unfinished and untreated wood means SUPPLEMENTARY INFORMATION:
to prepare an environmental assessment wood harvested from the trunks of trees Legal Authority
or an environmental impact statement with no added surface coatings (such as,
because they ‘‘have little or no potential The Drug Enforcement
varnish, paint, shellac, or polyurethane)
for affecting the human environment.’’ Administration (DEA) implements and
and no materials added to the wood
16 CFR 1021.5(c)(2). This rule falls enforces titles II and III of the
substrate (such as, stains, dyes,
within the categorical exclusion, so no Comprehensive Drug Abuse Prevention
preservatives, antifungals, or
environmental assessment or and Control Act of 1970, as amended.
insecticides). Unfinished and untreated
environmental impact statement is Titles II and III are referred to as the
wood does not include manufactured or
required. The Commission’s regulations ‘‘Controlled Substances Act’’ and the
engineered woods (such as pressed
state that safety standards for products ‘‘Controlled Substances Import and
wood, plywood, particle board, or
normally have little or no potential for Export Act,’’ respectively, and are
fiberboard).
affecting the human environment. 16 collectively referred to as the
Dated: July 13, 2015. ‘‘Controlled Substances Act’’ or the
CFR 1021.5(c)(1). Nothing in this rule
alters that expectation. Todd A. Stevenson, ‘‘CSA’’ for the purpose of this action. 21
Secretary, Consumer Product Safety U.S.C. 801–971. The DEA publishes the
List of Subjects Commission. implementing regulations for these
Business and industry, Infants and [FR Doc. 2015–17413 Filed 7–16–15; 8:45 am] statutes in title 21 of the Code of Federal
children, Consumer protection, Imports, BILLING CODE 6355–01–P Regulations (CFR), chapter II. The CSA
Product testing and certification, Toys. and its implementing regulations are
Accordingly, 16 CFR part 1251 is designed to prevent, detect, and
added to read as follows: DEPARTMENT OF JUSTICE eliminate the diversion of controlled
substances and listed chemicals into the
PART 1251—TOYS: DETERMINATIONS Drug Enforcement Administration illicit market while ensuring an
REGARDING HEAVY ELEMENTS adequate supply is available for the
LIMITS FOR CERTAIN MATERIALS 21 CFR Part 1308 legitimate medical, scientific, research,
and industrial needs of the United
Sec. [Docket No. DEA–413F]
1251.1 The toy standard and testing States. Controlled substances have the
requirements. Schedules of Controlled Substances: potential for abuse and dependence and
1251.2 Wood. Temporary Placement of Acetyl are controlled to protect the public
Authority: Sec. 3, Pub. L. 110–314, 122 Fentanyl Into Schedule I health and safety.
Stat. 3016; 15 U.S.C. 2063(d)(3)(B). Under the CSA, every controlled
AGENCY: Drug Enforcement substance is classified into one of five
§ 1251.1 The toy standard and testing Administration, Department of Justice. schedules based upon its potential for
requirements. ACTION: Final order. abuse, its currently accepted medical
The Consumer Product Safety use in treatment in the United States,
Improvement Act of 2008 (‘‘CPSIA’’) SUMMARY: The Administrator of the Drug and the degree of dependence the drug
made provisions of ASTM F963, Enforcement Administration is issuing or other substance may cause. 21 U.S.C.
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Consumer Product Safety Specifications this final order to temporarily schedule 812. The initial schedules of controlled
for Toy Safety (‘‘toy standard’’), a the synthetic opioid, N-(1- substances established by Congress are
mandatory consumer product safety phenethylpiperidin-4-yl)-N- found at 21 U.S.C. 812(c), and the
standard. Among the mandated phenylacetamide (acetyl fentanyl), and current list of all scheduled substances
provisions is section 4.3.5 of ASTM its optical, positional, and geometric is published at 21 CFR part 1308.
F963 which requires that surface coating isomers, salts and salts of isomers, into Section 201 of the CSA, 21 U.S.C. 811,
materials and accessible substrates of schedule I pursuant to the temporary provides the Attorney General with the
toys that can be sucked, mouthed, or scheduling provisions of the Controlled authority to temporarily place a

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Document Created: 2018-02-23 09:21:47
Document Modified: 2018-02-23 09:21:47
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Direct final rule.
Dates		The rule is effective on September 15, 2015, unless we receive a significant adverse comment by August 17, 2015. If we receive a timely significant adverse comment, we will publish notification in the Federal Register, withdrawing this direct final rule before its effective date.
Contact		Randy Butturini, Project Manager, Office of Hazard Identification and Reduction U.S. Consumer Product Safety Commission, 4330 East West Hwy, Room 814, Bethesda, MD 20814; 301-504-7562: email; [email protected]
FR Citation		80 FR 42376