Children's Products, Children's Toys, and Child Care Articles: Determinations Regarding Lead, ASTM F963 Elements, and Phthalates for Engineered Wood Products, 47645-47656 [2017-21980]
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Proposed Rules
Federal Register
Vol. 82, No. 197
Friday, October 13, 2017
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
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rule making prior to the adoption of the final
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SMALL BUSINESS ADMINISTRATION
[Docket No. SBA–2017–0005]
13 CFR Chapter I
Reducing Unnecessary Regulatory
Burden
U.S. Small Business
Administration.
ACTION: Request for information;
extension of comment period.
AGENCY:
On August 15, 2017, the
Small Business Administration (SBA or
Agency) published in the Federal
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seeking input from the public on
identifying which of the Agency’s
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60-day comment period closing on
October 16, 2017. SBA is extending the
public comment period for 30 days,
until November 15, 2017.
DATES: The comment period for the
request for information published on
August 15, 2017 (82 FR 38617) is
extended. Comments are requested on
or before November 15, 2017.
ADDRESSES: You may submit comments,
identified by Docket Number SBA–
2017–0005, using any of the following
methods:
Federal eRulemaking Portal: https://
www.regulations.gov. Identify
comments by ‘‘Docket Number SBA–
2017–0005, Reducing Regulatory
Burden RFI,’’ and follow the
instructions for submitting comments.
Mail: Holly Turner, Regulatory
Reform Officer, U.S. Small Business
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submit confidential business
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Notice at https://www.regulations.gov,
please submit the information to Holly
Turner, 409 Third Street SW.,
Washington, DC 20416. Highlight the
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SUMMARY:
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information that you consider to be CBI,
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whether to publish the information.
FOR FURTHER INFORMATION CONTACT:
Holly Turner, (202) 205–6335, 409
Third Street SW., Washington, DC
20416; email address: IGA@sba.gov.
SUPPLEMENTARY INFORMATION: On August
15, 2017, in accordance with Executive
Order 13777, ‘‘Enforcing the Regulatory
Reform Agenda,’’ SBA published a
request for information seeking input
from the public on identifying which of
the Agency’s regulations should be
repealed, replaced or modified because
they are obsolete, unnecessary,
ineffective, or burdensome (82 FR
38617). That request established a 60day comment period, closing on October
16, 2017. To ensure that all interested
parties are provided ample time and
opportunity to submit comments, SBA
is extending the public comment period
for an additional 30 days. Comments
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November 15, 2017.
Authority: 15 U.S.C. 634(b)(6); E.O. 13771;
E.O. 13777.
Dated: October 6, 2017.
Holly Turner,
Regulatory Reform Officer.
[FR Doc. 2017–22130 Filed 10–12–17; 8:45 am]
BILLING CODE 8025–01–P
CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1252
[Docket No. CPSC–2017–0038]
Children’s Products, Children’s Toys,
and Child Care Articles:
Determinations Regarding Lead, ASTM
F963 Elements, and Phthalates for
Engineered Wood Products
U.S. Consumer Product Safety
Commission.
ACTION: Notice of proposed rulemaking.
AGENCY:
The Consumer Product Safety
Commission (Commission, or CPSC) is
proposing a rule to determine that
certain untreated and unfinished
engineered wood products (EWPs),
specifically, particleboard, hardwood
plywood, and medium-density
SUMMARY:
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fiberboard, made from virgin wood or
pre-consumer waste wood would not
contain lead, the ASTM F963 elements,
or specified phthalates that exceed the
limits set forth under the CPSC’s
statutes for children’s products,
children’s toys, and child care articles.
Based on these proposed
determinations, the specified EWPs
would not be required to have third
party testing for compliance with the
requirements for lead, ASTM F963
elements, or phthalates for children’s
products, children’s toys, and child care
articles.
DATES: Submit comments by December
27, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CPSC–2017–
0038, by any of the following methods:
Electronic Submissions: Submit
electronic comments to the Federal
eRulemaking Portal at: https://
www.regulations.gov. Follow the
instructions for submitting comments.
The Commission does not accept
comments submitted by electronic mail
(email), except through regulations.gov.
The Commission encourages you to
submit electronic comments by using
the Federal eRulemaking Portal, as
described above.
Written Submissions: Submit written
comments 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. All comments received
may be posted without change,
including any personal identifiers,
contact information, or other personal
information provided, to: https://
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 by mail/
hand delivery/courier.
FOR FURTHER INFORMATION CONTACT:
Jacqueline Campbell, Senior Textile
Technologist, Office of Hazard
Identification and Reduction, U.S.
Consumer Product Safety Commission,
5 Research Place, Rockville, MD 20850:
Telephone 301–987–2024; email:
jcampbell@cpsc.gov.
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SUPPLEMENTARY INFORMATION:
A. Background
1. Third Party Testing and Burden
Reduction
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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, children’s toys, and
child care articles, certification must be
based on testing conducted by a CPSCaccepted 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).
To provide opportunities to reduce
the cost of third party testing
requirements consistent with assuring
compliance with any applicable
consumer product safety rule, ban,
standard, or regulations, the CPSC
assessed whether children’s products,
children’s toys, and child care articles
manufactured with three engineered
wood products, specifically,
particleboard, hardwood plywood, and
medium-density fiberboard (collectively
referred to as EWPs), would comply
with CPSC’s requirements for lead,
ASTM F963 elements or phthalates. If
the Commission determines that such
materials 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 testing laboratory to issue a
Children’s Product Certificate (CPC).
2. CPSC’s Lead Standard
Section 101 of the CPSIA has two
requirements associated with lead in
children’s products. 15 U.S.C. 1278a.
First, no accessible part of a children’s
product may contain more than 100
parts per million (ppm) lead content.
Second, paint or other surface coatings
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on children’s products and furniture
intended for consumer use may not
contain lead in concentrations greater
than 90 ppm. Manufacturers of
children’s products must certify, based
on third party testing, that their
products comply with all relevant
children’s product safety rules. Thus,
products subject to the lead content or
paint/surface coating limits require
passing test results from a CPSCaccepted third party laboratory for the
manufacturer to issue a CPC, before the
products can be entered into commerce.
To alleviate some of the third testing
burdens associated with lead in the
accessible component parts of children’s
products, the Commission determined
that certain materials, including
gemstones, precious metals, wood,
paper, CMYK process printing inks,
textiles, and specified stainless steel, do
not exceed the 100 ppm lead content
limit under section 101 of the CPSIA.
Based on this determination, such
materials do not require third party
testing for the lead content limits. The
determinations regarding lead content
for certain materials are set forth in 16
CFR 1500.91.
3. ASTM F963 Elements
Section 106 of the CPSIA provides
that the provisions of ASTM
International, Consumer Safety
Specifications for Toy Safety (ASTM
F963), shall be considered to be
consumer product safety standards
issued by the Commission.1 15 U.S.C.
2056b. The Commission has issued a
rule that incorporates by reference the
relevant provisions of ASTM F963. 16
CFR part 1250. Thus, children’s toys
subject to ASTM F963 must be tested by
a CPSC-accepted third party laboratory
and demonstrate compliance with all
applicable CPSC requirements for the
manufacturer to issue a CPC before the
children’s toys can be entered into
commerce.
Section 4.3.5 of ASTM F963 requires
that surface coating materials and
accessible substrates of children’s toys
that can be sucked, mouthed, or
ingested 2 must comply with the
1 ASTM F963 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 contains the following note
regarding the scope of the solubility requirement:
NOTE 4—For the purposes of this requirement, the
following criteria are considered reasonably
appropriate for the classification of children’s 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 children’s toys which
are cosmetics, and components of writing
instruments categorized as children’s toys; (2)
Children’s toys intended for children less than 6
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solubility limits of eight elements given
in Table 1 of the toy standard. The
materials and their solubility limits are
shown in Table 1. We refer to these
eight elements as ‘‘ASTM F963
elements.’’
TABLE 1—MAXIMUM SOLUBLE MIGRATED ELEMENT IN ppm (mg/kg)
FOR SURFACE COATINGS AND SUBSTRATES INCLUDED AS PART OF A
TOY
Elements
Antimony (Sb) ............................
Arsenic (As) ...............................
Barium (Ba) ................................
Cadmium (Cd) ...........................
Chromium (Cr) ...........................
Lead (Pb) ...................................
Mercury (Hg) ..............................
Selenium (Se) ............................
Solubility
limit,
(ppm) 3
60
25
1,000
75
60
90
60
500
The third party testing burden could
be reduced only if all 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 F963 elements, no testing burden
reduction would be achieved if any one
of the elements requires testing.
To alleviate some of the third testing
burdens associated with the ASTM F963
elements in the accessible component
parts of children’s toys, the Commission
determined that certain unfinished and
untreated trunk wood does not contain
ASTM F963 elements that would exceed
the limits specified in section 106 of the
CPSIA. Based on this determination,
unfinished and untreated trunk wood
would not require third party testing for
the ASTM F963 elements. The
determinations regarding the ASTM
F963 elements limits for certain
materials is set forth in 16 CFR 1251.2.
4. Phthalates
Section 108(a) of the CPSIA
permanently prohibits the manufacture
for sale, offer for sale, distribution in
commerce, or importation into the
United States of any ‘‘children’s toy or
child care article’’ that contains
concentrations of more than 0.1 percent
of di(2-ethylhexyl) phthalate (DEHP),
dibutyl phthalate (DBP), or butyl benzyl
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. Modeling clays included as part of a
toy have different solubility limits for several of the
elements.
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phthalate (BBP). 15 U.S.C. 2057c(a).
Section 108(b)(1) prohibits on an
interim basis (i.e., until the Commission
promulgates a final rule), the
manufacture for sale, offer for sale,
distribution in commerce, or
importation into the United States of
‘‘any children’s toy that can be placed
in a child’s mouth’’ or ‘‘child care
article’’ containing concentrations of
more than 0.1 percent of diisononyl
phthalate (DINP), diisodecyl phthalate
(DIDP), or di-n-octyl phthalate (DnOP).
15 U.S.C. 2057c(b)(1). Children’s toys
and child care articles subject to the
content limits in section 108 of the
CPSIA require third party testing for
compliance with the phthalate content
limits before the manufacturer can issue
a CPC and enter the children’s toys or
child care articles into commerce.
The CPSIA required the Commission
to appoint a Chronic Hazard Advisory
Panel (CHAP) to ‘‘study the effects on
children’s health of all phthalates and
phthalate alternatives as used in
children’s toys and child care articles.’’
15 U.S.C. 2057c(b)(2). The CHAP issued
its report in July 2014.4 Based on the
CHAP report, the Commission
published a notice of proposed
rulemaking (Phthalates NPR),5
proposing to permanently prohibit
children’s toys and child care articles
containing concentrations of more than
0.1 percent of DINP, and proposing to
lift the interim statutory prohibitions
with respect to DIDP and DnOP. In
addition, the Phthalates NPR proposed
adding four new phthalates, DIBP,
DPENP, DHEXP, and DCHP, to the list
of phthalates that cannot exceed 0.1
percent concentration in accessible
component parts of children’s toys and
child care articles. The Commission has
not finalized its proposal on phthalates
in children’s toys and child care
articles.
Tests for phthalate concentration are
among the most expensive certification
tests to conduct on a product, and each
accessible component part subject to
section 108 of the CPSIA must be
tested.6 Third party testing burden
reductions can occur only if each
phthalate’s concentration is below 0.1
percent (1000 ppm). Because
laboratories typically run one test for all
of the specified phthalates, no testing
4 https://www.cpsc.gov/PageFiles/169902/CHAPREPORT-With-Appendices.pdf.
5 https://www.federalregister.gov/articles/2014/
12/30/2014-29967/prohibition-of-children’s-toysand-child-care-articles-containing-specifiedphthalates.
6 Test costs for the content of all the specified
phthalates have been reported to range from $125
to $350 per component, depending upon where the
tests are conducted and any discounts that might
apply.
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burden reduction likely is achieved if
any one of the phthalates requires
compliance testing.
To alleviate some of the third testing
burdens associated with plastics in the
accessible component parts of children’s
toys and child care articles, the
Commission determined that products
made with general purpose polystyrene
(GPPS), medium-impact polystyrene
(MIPS), high-impact polystyrene (HIPS),
and super high-impact polystyrene
(SHIPS) with specified additives do not
exceed the phthalates content limits
under section 108 of the CPSIA. 82 FR
41163 (August 30, 2017). Based on this
determination, materials used in
children’s toys and child care articles
that use these specified plastics and
additives would not require third party
testing for the phthalates content limits.
The plastics determinations are set forth
in the Commission’s regulations at 16
CFR part 1308.
The research that provides the basis
for the phthalates determination covers
the six phthalates subject to the
statutory prohibition and the additional
phthalates that the Commission
proposed to prohibit from use in
children’s toys and child care articles.
After the Commission finalizes its
phthalates rule, the Commission will
revise its phthalate determination rule
to reflect the phthalates restricted by the
final phthalates rule.
B. Contractor’s Research
CPSC contracted with the Toxicology
Excellence for Risk Assessment
(TERA) 7 who authored literature review
reports on the content issues related to
certain natural materials, plastics, and
EWPs. The following reports produced
by TERA formed the basis for the
proposed EWP determinations: Task 9,
Concentrations of Selected Elements in
Unfinished Wood and Other Natural
Materials; Task 11, Exposure
Assessment: Composition, Production,
and Use of Phthalates; and Task 14,
Final Report for CPSC Task 14, which
summarized the available information
on the production of the EWPs. Each
report is discussed below.
1. TERA Task 9 Report
In the Task 9 Report, TERA conducted
a literature search on whether
unfinished wood and other natural
materials could be determined not to
contain any of the ASTM F963 elements
in concentrations greater than the
7 After conducting the contract reports for the
CPSC, TERA reorganized as the Risk Science Center
at the University of Cincinnati: https://med.uc.edu/
eh/centers/rsc.
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ASTM F963 solubility limits.8 The
materials researched included
unfinished woods (ash, beech, birch,
cherry, maple, oak, pine, poplar, and
walnut); bamboo; beeswax; undyed and
unfinished fibers and textiles (cotton,
wool, linen, and silk); and uncoated or
coated paper (wood or other cellulosic
fiber).
To assess the presence of the ASTM
F963 elements’ concentrations in the
materials, TERA looked at several
factors. The factors reviewed included
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 ASTM F963
elements into the material under study;
and the potential for contamination after
production, such as through packaging.
From this report, the Commission
determined that untreated and
unfinished woods from tree trunks do
not contain any of the elements in
ASTM F963 in concentrations greater
than their respective solubility limits,
and thus, they are not required to be
third party tested to ensure compliance
with the specified solubility test.9 TERA
relied on this information in TERA Task
Report 14 to determine that the virgin
wood material used in the manufacture
of EWPs does not, and will not, contain
any of the elements in ASTM F963 in
concentrations greater than their
respective solubility limits.
2. TERA Task 11 Report
In the Task 11 Report, TERA
conducted a literature search on the
production and use of 11 specified
phthalates in consumer products.10 The
11 phthalates researched by TERA were
based on the recommendations made in
the CHAP report. Table 2 lists the
phthalates researched by TERA. TERA’s
research focused on the following
factors:
• The raw materials used in the
production of the specified phthalates;
• The manufacturing processes used
worldwide to produce the specified
phthalates;
• Estimated annual production of the
specified phthalates;
• Physical properties of the specified
phthalates (e.g., vapor pressure,
flashpoint, water solubility, temperature
at which chemical breakdown occurs);
8 https://www.cpsc.gov/Global/Research-andStatistics/TechnicalReports/Toys/
TERAReportASTMElements.pdf.
9 80 FR 78651 (Dec. 17, 2015).
10 https://www.cpsc.gov//Global/Research-andStatistics/Technical-Reports/
Other%20Technical%20Reports/
TERAReportPhthalates.pdf.
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• Applications for phthalates use in
materials and consumer and nonconsumer products; and
• Other potential routes by which
phthalates can be introduced into an
otherwise phthalates-free material (e.g.,
migration from packaging, recycling,
reuse, product breakdown).
TABLE 2—PHTHALATES RESEARCHED IN THE TASK 11 REPORT
CASRN 11
Phthalate
DEHP: di-(2-ethylhexyl) phthalate ..................................................................................................................................
DBP: dibutyl phthalate ....................................................................................................................................................
BBP: benzyl butyl phthalate ...........................................................................................................................................
DINP: diisononyl phthalate .............................................................................................................................................
DIDP: diisodecyl phthalate .............................................................................................................................................
DnOP: di-n-octyl phthalate .............................................................................................................................................
DIOP: diisooctyl phthalate ..............................................................................................................................................
DIBP: diisobutyl phthalate ..............................................................................................................................................
DPENP: di-n-pentyl phthalate .........................................................................................................................................
DHEXP: di-n-hexyl phthalate ..........................................................................................................................................
DCHP: dicyclohexyl phthalate ........................................................................................................................................
TERA found that phthalates are used
generally as plasticizers or softeners of
certain plastics, primarily polyvinyl
chloride (PVC), as solvents, and as
component parts of inks, paints,
adhesives, and sealants.
3. TERA Task 14 Report
In the Task 14 Report, TERA
conducted a literature search on the
production of three EWPs:
Particleboard, hardwood plywood, and
medium-density fiberboard.12 TERA
first researched authoritative sources,
such as reference books and textbooks,
along with Internet resources, for
general information about EWPs,
adhesives, raw materials, manufacturing
processes, and the potential use of
recycled materials. TERA used this
information and consulted technical
experts to identify key words for
searching the literature. These key
words were then used to conduct
primary literature searches for research
studies and publications. In addition,
TERA searched for Safety Data Sheets
(SDS) for information on raw materials.
117–81–7
84–74–2
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26761–40–0, 68515–49–1
117–84–0
27554–26–3
84–69–5
131–18–0
84–75–3
84–61–7
TERA researched the possibility of the
raw materials or finished products in
the three EWPs to contain:
• Lead in concentrations exceeding
100 ppm;
• Any of the specified elements that
are included in the safety standard for
children’s toys, ASTM F963, Standard
Consumer Safety Specification for Toy
Safety, in concentrations exceeding
specified solubility limits; or
• Any of 10 specified phthalates in
concentrations greater than 0.1 percent
(1000 ppm), listed in Table 3.13
TABLE 3—PHTHALATES RESEARCHED IN THE TASK 14 REPORT 14
Phthalate
CASRN
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DEHP: di-(2-ethylhexyl) phthalate ..................................................................................................................................
DBP: dibutyl phthalate ....................................................................................................................................................
BBP: benzyl butyl phthalate ...........................................................................................................................................
DINP: diisononyl phthalate .............................................................................................................................................
DIDP: diisodecyl phthalate .............................................................................................................................................
DnOP: di-n-octyl phthalate .............................................................................................................................................
DIBP: diisobutyl phthalate ..............................................................................................................................................
DPENP: di-n-pentyl phthalate .........................................................................................................................................
DHEXP: di-n-hexyl phthalate ..........................................................................................................................................
DCHP: dicyclohexyl phthalate ........................................................................................................................................
TERA found that, generally, the
processes for manufacturing the three
EWPs are similar; wood fibers, chips,
layers, or a similar raw wood product
are processed with various adhesive
formulations (sometimes referred to as
binders or resins) along with other
additives to create uniform sheets with
known characteristics and performance
qualities. The main difference among
the three types of EWPs relates
11 A CAS Registry Number is assigned to a
substance when it enters the CAS REGISTRY
database. https://www.cas.org/content/chemicalsubstances/faqs.
12 https://www.cpsc.gov/s3fs-public/
ManufacturedWoodsTERATask14Report.pdf.
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117–81–7
84–74–2
85–68–7
28553–12–0, 68515–48–0
26761–40–0, 68515–49–1
117–84–0
84–69–5
131–18–0
84–75–3
84–61–7
primarily to the size and morphology
(shape and surface characteristics) of the
wood material used in their production.
TERA reviewed the literature to assess
whether the specified EWPs might
contain lead or one or more of the other
elements at levels that exceed the ASTM
solubility limits, or any of the specified
phthalates in concentrations greater
than the specified limits. TERA reported
that no studies found lead, the ASTM
F963 elements, or the specified
phthalates in concentrations greater
than their limits in particleboard,
hardwood plywood, or medium-density
fiberboard, that are unfinished and
untreated, and made from virgin wood
or pre-consumer wood waste.
In the Task 14 Report, TERA
described an unfinished EWP as one
that does not have any surface
treatments applied at manufacture, such
13 The TERA research providing the basis for this
determination covers the six phthalates subject to
the statutory prohibition, as well as the additional
phthalates the Commission proposed to prohibit in
children’s toys and child care articles. The
phthalates determination lists only the six
phthalates subject to the statutory prohibition.
However, when the Commission issues a final rule
for the specified phthalates in children’s toys and
child care articles, the Commission could revise the
phthalates determination, if needed.
14 While included in the Task 11 Report, DIOP
was not included in the Task 14 Report because the
ban on DIOP was proposed to be removed in the
Phthalates NPR.
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as factory-applied coatings. An
untreated EWP is one that does not have
any additional finishes applied at
manufacture such as flame retardants or
rot resistant finishes. TERA described
virgin wood as wood logs, fibers, chips,
or layers that have not been recycled
from a previous use. TERA described
pre-consumer wood waste as wood
materials that have been recycled from
an industrial process before being made
available for consumer use. Examples of
this type of waste include trimmings
from EWP panel manufacturing,
sawdust from cutting logs, or remaining
wood pieces from sawing a log into
framing lumber.
The TERA report highlighted the
potential for lead, the ASTM F963
elements, or the specified phthalates to
be present in concentrations greater
than those specified through the use of
contaminated recycled material in EWPs
made from recycled wood waste or
EWPs that have post-manufacturing
treatments or finishes. Recycled wood
waste may be made from reclaimed or
post-consumer wood waste. Postconsumer wood waste is described as
wood waste that is comprised of
materials that are recovered from their
original use and subsequently used in a
new product. Examples of this type of
waste include recycled demolition
wood, packaging materials such as
pallets and crates, used wood from
landscape care (i.e., from urban and
highway trees, hedges, and gardens),
discarded furniture, and waste wood
from industrial, construction, and
commercial activities.
The three types of EWPs reviewed by
TERA are discussed below.
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a. Particleboard
Particleboard is a composite of wood
chips, adhesives, and other additives
pressed into a board. Adhesive
formulations are used to bond wood
chips, which are then formed into mats
that are layered to create uniform boards
in a range of dimensions. Particleboard
is used widely in furniture making and
other interior (or nonstructural) uses.
The constituent parts of particleboard
reported by TERA can include (by
weight):
• Wood (60–99+ percent);
• Adhesive formulation (0–17
percent, with 5–11 percent most
common)
• May include phenol-formaldehyde
(uncommon but potential for use), ureaformaldehyde, melamine-ureaformaldehyde, polymeric methylenediphenyl-diisocyanate (pMDI);
• Waxes (0.3–1 percent);
• Other additives (up to 2 percent); or
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• Scavengers or additional
unspecified materials.
TERA researched the possibility of
lead, the ASTM F963 elements, or the
specified phthalates, in concentrations
greater than their specified limits in
particleboard. TERA identified little
information on measurements of lead
and the ASTM F963 elements in
particleboard and no studies that
measured the specified phthalates.
TERA identified two references where
particleboard made from both untreated
and copper chromate arsenic-(CCA)
treated wood chips was tested. Arsenic
and chromium were undetected in the
particleboards made from virgin wood
chips. However, the particleboard
composed of 25 percent wood chips
from reclaimed CCA-treated wood
products contained 895 and 832 ppm of
arsenic and chromium, respectively,
without adversely affecting the
mechanical performance of the board.
Another study that discussed ‘‘recycled
particleboard’’ was identified as wood
waste obtained from a wood recycling
plant.
Apart from the studies on
particleboard made from wood waste
that may contain post-consumer wood
waste or post-manufacturing treatments,
TERA reported that no studies found
lead, the ASTM F963 elements, or the
specified phthalates in concentrations
greater than the specified limits in
untreated and unfinished particleboard.
b. Hardwood Plywood
Plywood is a layered board of wood
veneers where the layers have
alternating, perpendicular wood grain
directions. Less commonly, the board
might have a core of other EWPs with
wood veneers as the outer layers.
Hardwood plywood, addressed in this
report, is a type of plywood that is
composed of angiosperms (i.e.,
‘‘hardwoods,’’ such as oak or maple)
and used primarily in furniture and
other interior (nonstructural) uses, as
well as in playground equipment, sports
equipment, and musical instruments.
The constituent parts of hardwood
plywood reported by TERA can include
(by weight):
• Wood (75–99+ percent);
• Adhesive formulation (0.02–20
percent, with 1 percent to 5 percent
most common)
• May include phenol-formaldehyde
or phenol-resorcinol-formaldehyde
(likely for use in structural plywood but
potential for application to hardwood
plywood), urea-formaldehyde,
melamine-formaldehyde, or melamineurea-formaldehyde, or polyvinyl acetate
(PVAc); or
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• Other additives (less than 2
percent).
TERA researched the possibility of
lead, the ASTM F963 elements, or the
specified phthalates in concentrations
greater than those specified in
hardwood plywood. TERA identified
only one study that measured lead and
the ASTM F963 elements in plywood
and no studies that measured the
specified phthalates. Concentrations of
cadmium, chromium, and lead, were all
less than the solubility limits, in ‘‘plain’’
plywood. In addition, because
hardwood plywood is made from sheets
of wood veneer, it is less likely to
contain recycled wood content, unless it
incorporates a core of some other EWP,
such as particleboard or mediumdensity fiberboard.
Aside from the studies on recycled
wood waste that may contain postconsumer wood waste or postmanufacturing treatments in a
particleboard, medium-density
fiberboard, or other EWP core, TERA
reported that no studies found lead, the
ASTM F963 elements, or the specified
phthalates in concentrations greater
than the specified limits in untreated
and unfinished hardwood plywood.
However, TERA identified research
which indicated that polyvinyl acetate
(PVAc) can be used as an adhesive
system for hardwood plywood as
discussed in section (d) below.
c. Medium-Density Fiberboard
Medium-density fiberboard (MDF) is a
composite of wood fibers, an adhesive
formulation, and other additives pressed
into a board. MDF is a similar product
to particleboard, differing mostly due to
the use of fiber rather than chips. It is
used primarily in furniture and other
interior (nonstructural) uses. The
constituent parts of MDF reported by
TERA can include (by weight):
• Wood (73–99+ percent);
• Adhesive formulation (0–25 percent
with most common 5–12 percent);
• May include phenol-formaldehyde
(uncommon, but potentially used for
moisture resistance), urea-formaldehyde
(most commonly identified), methylenediphenyl-diisocyanate (pMDI),
melamine-formaldehyde, or melamineurea-formaldehyde;
• Waxes (less than 1 percent); or
• Other additives (10–30 percent).
TERA researched the possibility of
lead, the ASTM F963 elements, or the
specified phthalates in concentrations
greater than those specified in MDF.
TERA did not identify any references
that reported the presence of lead, the
ASTM F963 elements, or the specified
phthalates in MDF made with virgin
wood.
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Aside from the studies on recycled
wood waste that may contain postconsumer wood waste or postmanufacturing treatments, TERA
reported that no studies found lead, the
ASTM F963 elements, or the specified
phthalates in concentrations greater
than the specified limits in untreated
and unfinished MDF.
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d. TERA’s Findings on EWP Constituent
Parts
Because few references were found
directly addressing lead, the ASTM
F963 elements, and the specified
phthalates in EWPs, TERA also
researched the constituent parts that
could be used to manufacture EWPs,
including wood and adhesives.
Wood
According to the manufacturing
process information provided by TERA,
virgin wood and wood residues are the
main source of wood fiber used in North
America to manufacture EWPs.
Typically, these sources include low
value logs, industrial wood residues, or
scraps and trim from furniture and EWP
production. For example, hardwood
plywood requires the trunks of trees to
obtain the thin layers of veneer used to
construct a sheet. TERA relied on the
Task 9 Report and Commission findings
on unfinished and untreated wood (80
FR 78651 (Dec. 17, 2015)) to determine
that untreated and unfinished wood
from the trunks of trees do not contain
lead or the ASTM F963 elements in
concentrations greater than the specified
solubility limits. TERA also noted that,
although phthalates can be taken up by
trees and plants, the concentrations are
negligible and less than the specified
limit (0.1 percent).
Although TERA reported that the
majority of EWPs are manufactured with
virgin wood or pre-consumer wood
waste fiber or chips, the wood
component also can originate from
recycled material. For EWPs made from
recycled wood waste that may contain
post-consumer wood waste, the TERA
report highlighted the potential for lead,
the ASTM F963 elements, or the
specified phthalates to be present in
concentrations greater than those
specified through the use of
contaminated recycled material. The
TERA report cited multiple examples of
the use of reclaimed or post-consumer
wood material used to produce EWPs,
both domestically and internationally.
Specifically, TERA found studies
showing that reclaimed lumber and
wood waste could contain a myriad of
contaminants, such as surface
treatments (e.g., paints, stains), metals,
glues and adhesives, glass, paper,
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plastic, rubber and chemical treatments.
Metals and organic materials may be
present in paints, stains, varnishes, and
polishes that are used on wood products
(e.g., furniture, window frames) and
nails, screws, and other metal hardware
might be attached to the recycled and
recovered wood. These contaminants
are intimately attached to the wood, and
therefore, some contaminants may pass
through cleaning systems,
contaminating the entire recovered
wood stream.
TERA also reviewed another study,
based in Italy that evaluated the
‘‘recyclability’’ of used wood by
conducting elemental analysis of wood
residues from wood recycling plants
using a handheld fast energy dispersive
X-ray fluorescence spectroscopy (ED–
XRF) device. TERA found that the study
provided some indication of types and
levels of contamination in various kinds
of post-consumer wood waste.
Elemental analysis results were
compared to EU Community Ecolabel
limits.15 For all wood products tested,
16 percent exceeded one or more of the
Ecolabel limits, with the highest
concentrations from lead, chromium,
chlorine, copper, cadmium, and
mercury. No samples had levels of
arsenic over the 25 ppm limit (except a
CCA-treated utility pole). Barium and
lead were found in 10 percent to 20
percent of the samples, chromium and
cadmium in 3 percent to 4 percent, and
antimony, mercury, and arsenic ranged
from 0.3 percent to 1.2 percent of
samples. The sources most
contaminated with non-wood content
were from furniture and building
materials, while pallets and shipping
containers were least likely to be
contaminated.16
TERA concluded that, with an
increased interest and use of postconsumer recycled materials in EWP
production, potential contamination by
the specified elements and phthalates
must be considered. To ensure that
EWPs made from used wood fibers do
not contain ASTM F963 elements or
phthalates the exceed the specified
15 Ecolabel element concentrations are less than
25 mg/kg of arsenic, 25 mg/kg of mercury, 25 mg/
kg of chromium, 50 mg/kg cadmium, 90 mg/kg lead,
and 40 mg/kg copper (EU, 2004). Ecolabel limits are
similar to ASTM solubility limits for the ASTM
F963 elements.
16 Twenty-four percent of furniture and 18
percent of building materials had one or more
ASTM F963 elements exceeding the limits which
may be due to manufacturing processes such as
painting, preservation, and overlaying, which are
common with furniture and building materials. The
most polluted types of wood waste were
particleboard (37% exceeded Ecolabel limits),
recycled particleboard (25% exceeded), and
plywood (18% exceeded); while fiberboard (MDF
and HDF) exceeded limits in 9 percent of samples.
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limits, TERA indicated that the
materials would need to be sorted
carefully and tested to be assured that
they are not contaminated.
Adhesive Formulations
Adhesive formulations hold the wood
chips, layers, or fibers together to make
EWP mats and sheets. Some of the
formulations use a metal catalyst during
the curing process. TERA identified a
number of references describing the
presence of the ASTM F963 elements in
adhesive formulations. However, TERA
found very few references that would
implicate EWPs. Although the use of
barium was noted in multiple
references, only one study appeared to
be relevant to EWPs. This study
suggested that barium, when used as a
catalyst in an adhesive, could result in
an EWP that exceeded the ASTM
solubility level for barium.17 However,
this method does not appear to be used
currently in EWP production. TERA
also noted studies that indicate the
possible use of chromium as a catalyst
in phenol formaldehyde resin as well as
the possible use of antimony or arsenic
in a drier formulation for certain
polymeric coatings. However, no
references included information on
concentrations or appeared relevant to
EWPs.
Although many different adhesive
formulations may be used in hardwood
plywood, TERA noted that PVAc can be
used as an adhesive system for
hardwood plywood. The report cited
sources (The Handbook of Adhesive
Technology, USDA) that mentioned the
use of some of the specified phthalates
in PVAc adhesive formulations.18 TERA
also identified research papers which
included the use of DBP and DEHP in
PVAc at concentrations greater than 0.1
percent.
17 Wang and Zhang (2011) studied the use of
calcium hydroxide, Ba(OH)2, and magnesium
hydroxide and their effect on cure times for phenol
formaldehyde adhesive formulations, finding that
the use of Ba(OH)2 could be a viable means to speed
up cure times. Both calcium hydroxide and Ba(OH)2
had similar cure times and are about the same price
in bulk. Because the compounds would be used in
an adhesive system, the catalyst is not expected to
be recovered and so would remain in situ once
curing is complete. If the catalyst remained in the
adhesive, it could result in concentrations of
barium exceeding the ASTM solubility limits.
18 The USDA publication Wood Handbook: Wood
as an Engineering Material (2010) explains that
‘‘Plasticizers, for example dibutyl phthalate, are
used to soften the brittle vinyl acetate homopolymer
in poly(vinyl acetate) emulsion adhesives. This is
necessary to facilitate adhesive spreading and
formation of a flexible adhesive film from the
emulsion at and below room temperature.’’
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C. CPSC Staff Analysis of TERA Reports
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1. EWPs Made From Virgin Wood or PreConsumer Wood Waste
CPSC staff reviewed the TERA Task 9,
11 and 14 Reports. CPSC staff also
examined TERA’s source references to
better understand the reports’ findings.
CPSC’s review of TERA’s Task 14
Report showed that there were few
studies characterizing the content of
EWPs, as manufactured, in relation to
lead and the ASTM F963 elements, and
no studies were found on the phthalates
of interest. Where there were studies,
staff’s review of the TERA report
showed there was no evidence that
untreated and unfinished EWPs made
from virgin wood or pre-consumer wood
waste, using generally used
manufacturing practices and materials,
had content levels greater than the
specified limits.
Staff finds that, based on the TERA
reports, untreated and unfinished EPWs
(particleboard, hardwood plywood, and
medium-density fiberboard) made from
virgin wood or pre-consumer wood
waste, do not contain lead, or any of the
specified elements in ASTM F963 that
exceed the specified limits. In addition,
with the exception of hardwood
plywood that contains PVAc adhesive
formulations, discussed further in this
section, the specified EWPs do not
contain any of the specified phthalates
in concentrations greater than 0.1
percent.
2. EWPs Made From Reclaimed or PostConsumer Wood Waste
The TERA Task 14 Report highlighted
the risk of introducing materials
contaminated with lead, the ASTM
F963 elements, and the specified
phthalates when using reclaimed or
post-consumer wood waste to
manufacture EWPs. Staff is aware that
there is increasing interest in using
recycled materials, rather than
landfilling. Environmentally oriented
initiatives encourage recycled wood
content, especially in the European
Union (E.U.). The E.U. Waste
Framework Directive requires recycling
or reuse of at least 70 percent of
construction and demolition waste in
member states by 2020.19
Staff’s review of TERA’s reclaimed or
post-consumer waste assessment in
EWPs indicates that, although most
manufacturing in the Americas
currently does not use post-consumer
wood waste as a constituent part, EWPs
with post-consumer wood content are
not only technologically feasible, but
19 https://ec.europa.eu/environment/waste/
construction_demolition.htm.
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also are currently available. Although
the majority of the post-consumer wood
waste used to manufacture EWPs is
‘‘clean,’’ consisting of wood pallets,
spools, or shipping crates, reclaimed
materials could be contaminated with
paint, coatings, or chemical treatments.
There are some standards (e.g.,
European Panel Federation, E.U.
Community Ecolabel) for EWPs with
content requirements that roughly align
with the ASTM F963 requirements;
however, many are voluntary and have
no third party testing requirements.
Staff notes that manufacturers do have
an incentive to avoid contamination of
EWPs because the addition of recycled
materials could be detrimental to
manufacturing equipment or the
finished product’s performance. Surface
coatings, such as paint or stains, metals
from nails or fasteners, adhesive
formulations, such as resins or glues,
and other non-wood content can
potentially damage equipment, stop a
production line, or adversely impact the
uniformity of the product. However,
staff is not aware of any current
manufacturer processing protocols that
would keep unwanted contaminants out
of EWP manufacturing. Because of the
contamination issues identified, the
staff does not have a high degree of
assurance that EWPs made from postconsumer wood waste are compliant
with sections 101, 106, or 108 of the
CPSIA at this time.
3. EWPs With Post-Manufacturing
Treatments or Finishes
Staff’s review of the Task 14 Report
shows that most consumer products
made from EWPs will have some
additional treatments or finishes that are
applied to the EWPs after their
manufacture. TERA’s report identified
that certain surface treatments (e.g.,
paints, stains), metals, glues and
adhesives, glass, paper, plastic, rubber
and chemical treatments may be added
to EWPs. Metals and organic materials
may be present in paints, stains,
varnishes, and polishes that are used on
wood products (e.g., furniture, window
frames) and nails, screws, and other
metal hardware might be attached to the
recycled and recovered wood.
Staff’s review shows that postmanufacturing treatments or finishes
made be applied to EWPs manufactured
from virgin or pre-consumer wood
waste, as well as EWPs manufactured
from post-consumer wood waste. Such
treatments or finishes may include paint
or similar surface coating materials,
flame retardants, rot resistant finishes,
wood glue, or metal fasteners. The
TERA report indicated that coatings,
finishes, and chemical treatments, such
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flame-retardant coatings or rot resistant
finishes, are a potential source of
phthalates or the ASTM F963 elements.
Staff’s review of EWPs that have postmanufacturing treatments or finishes
shows that there is potential for lead,
the ASTM F963 elements, or the
specified phthalates to be present in
concentrations greater than at the
specified levels. Unless a postmanufacture treatment or finish has
been determined by the CPSC to be
compliant with sections 101, 106, or 108
of the CPSIA,20 staff does not have a
high degree of assurance that EWPs that
have post-manufacturing treatments or
finishes are compliant with sections
101, 106, or 108 of the CPSIA at this
time.
4. Adhesive Formulations in EWPs
The Task 14 Report generally found
that there was little evidence to suggest
that the ASTM F963 elements are likely
to be present in any of the commonly
used adhesives in concentrations greater
than the ASTM solubility limits. Staff
notes, that although one study suggested
that barium, when used as a catalyst in
an adhesive, could result in an EWP that
exceeded the ASTM solubility level for
barium, this method does not appear to
be used currently in EWP production.
Staff’s review of the Task 11 Report
indicates that phthalates could be used
in some adhesive formulations,
including in PVAc adhesives, such as
wood or craft glues. In addition, the
Task 14 Report identified the adhesive
formulations used in the manufacture of
EWPs and found that one, PVAc, could
contain at least one of the specified
phthalates. TERA also reported that
PVAc could be used in hardwood
plywood manufacturing. However,
TERA was unable to identify whether
the specific PVAc adhesive formulations
used currently in the manufacture of
hardwood plywood contained any of the
specified phthalates in concentrations
greater than the specified limits.
CPSC staff research indicates that
PVAc may be associated with the
manufacture of hardwood plywood,
consistent with TERA’s finding. One
manufacturer of EWP adhesive
formulations provided information
through a contact at the USDA Forest
Products Laboratory. The manufacturer
confirmed that, while current
formulations no longer use phthalates,
PVAc adhesive formulations they
manufacture contained phthalates in the
past. The manufacturer also stated that
there is greater use of PVAc adhesive
formulations in hardwood plywood
20 See 16 CFR 1500.91; 16 CFR 1250.2; 16 CFR
part 1308.
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than indicated in the TERA report,
perhaps due to an increasing interest in
lowering formaldehyde emissions from
EWPs. Because of the lack of
information regarding the use of PVAc
adhesives containing the specified
phthalates in concentrations greater
than those allowed, staff does not have
a high degree of assurance that EWPs
that include PVAc adhesive
formulations in hardwood plywood are
compliant with sections 101, 106, or 108
of the CPSIA at this time.
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D. Determinations for EWPs
1. Legal Requirements for a
Determination
As discussed in section A.1. of the
preamble, 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). Children’s products must
comply with the lead limits in section
101 of the CPSIA. 15 U.S.C. 1278a.
Children’s toys must comply with the
solubility limits for elements under the
ASTM toy standard in section 106 of the
CPSIA. 15 U.S.C. 2056b. Children’s toys
and child care articles must comply
with the phthalates prohibitions in
section 108 of the CPSIA. 15 U.S.C.
2057c. 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 children’s products, children’s
toys, and child care articles would not
require third party testing.
To issue a determination that an EWP
does not require third party testing, the
Commission must have sufficient
evidence to conclude that the product
consistently complies with the CPSC
requirements to which the EWP is
subject so that third party testing is
unnecessary to provide a high degree of
assurance of compliance. Under 16 CFR
part 1107 section 1107.2, ‘‘a high degree
of assurance’’ is defined as ‘‘an
evidence-based demonstration of
consistent performance of a product
regarding compliance based on
knowledge of a product and its
manufacture.’’
For accessible component parts of
children’s products, children’s toys, and
child care articles subject to sections
101, 106, and 108 of the CPSIA,
compliance to the specified content
limits is always required, irrespective of
any testing exemptions. Thus, a
manufacturer or importer who certifies
a children’s product, toy or child care
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article, must assure the product’s
compliance. The presence of lead, the
ASTM F963 elements, or the specified
phthalates does not have to be intended
to require compliance. The presence of
these chemicals, whether for any
functional purpose, as a trace material,
or as a contaminant, must be in
concentrations less than the specified
content or solubility limits for the
material to be compliant. Additionally,
the manufacturer or importer must have
a high degree of assurance that the
product has not been adulterated or
contaminated to an extent that would
render it noncompliant. For example, if
a manufacturer or importer is relying on
a determination that an EWP does not
contain lead, ASTM F963 elements, or
specified phthalates in concentrations
greater than the specified limits in a
children’s product, children’s toy, or
child care article, the manufacturer
must ensure that the EWP is one on
which a determination has been made.
Furthermore, under the proposed
rule, any determinations that are made
on EWPs are limited to unfinished and
untreated EWPs made from virgin wood
or pre-consumer wood waste. Children’s
products, children’s toys, and child care
articles made from these EWPs may
have other materials that are applied to
or added on to the EWP after it is
manufactured, such as treatments and
finishes. Such component parts fall
outside of the scope of the proposed
determinations and would be subject to
third party testing requirements, unless
the component part has a separate
determination which does not require
third-party testing for certification
purposes. Finally, even if a
determination is in effect and third
party testing is not required, a certifier
must still issue a certificate.
The three engineered woods for
which the determinations are proposed
are: Particleboard, hardwood plywood,
and medium-density fiberboard. Based
on staff’s review of the TERA reports as
discussed in section C. of the preamble,
the Commission is proposing
determinations that there is a high
degree of assurance that these three
EWPs in an untreated and unfinished
state made from virgin or pre-consumer
wood waste will not contain lead, the
ASTM F963 elements, or the specified
phthalates in excess of allowable levels.
Specifically, the Commission is
proposing determinations that would
find that particleboard and MDF that is
untreated and unfinished and made
with virgin wood or pre-consumer wood
waste, would not contain lead, the
ASTM F963 elements, or the specified
phthalates (DEHP, DBP, BBP, DINP,
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DIDP, or DnOP) in concentrations
greater than their specified limits.
In addition, with the exception of
hardwood plywood that contains PVAc
adhesive formulations, untreated and
unfinished hardwood plywood made
with virgin wood or pre-consumer wood
waste would be determined not to
contain lead, the ASTM F963 elements,
and the specified phthalates in
concentrations greater than their
specified limits.
These determinations would mean
that, for the specified EWPs, third party
testing is not required to assure
compliance with sections 101, 106, and
108 of the CPSIA. The Commission
proposes to make these determinations
to reduce the third party testing burden
on children’s product certifiers while
continuing to assure compliance.
2. 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. Section 14 of the CPSA, which
was amended by the CPSIA, requires
third party testing for children’s
products 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
propose a rule determining that certain
EWPs would not be determined to
contain lead, the ASTM F963 elements,
and the specified phthalates (DEHP,
DBP, BBP, DINP, DIDP, or DnOP) 21 in
concentrations greater than their
specified limits, and thus, are not
required to be third party tested to
assure compliance with sections 101,
106, and 108 of the CPSIA.
The proposed determinations would
relieve the three specified EWPs from
the third party testing requirement of
section 14 of the CPSA for purposes of
supporting the required certification.
However, the proposed determinations
would not be applicable to any other
EWPs beyond those listed in the
proposed rule. Moreover, the proposed
determinations are not applicable to
EWPs that are not made of virgin wood
or pre-consumer wood waste, or to
21 See
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EWPs that have post-manufacture
treatments or finishes. The proposed
determinations also are not applicable
to hardwood plywood that contain
PVAc adhesive formulations. The
proposed determinations would only
relieve the manufacturers’ obligation to
have the specified EWPs tested by a
CPSC accepted third party conformity
assessment body. Children’s products,
children’s toys, and child care articles
must still comply with the substantive
content limits in section 101, 106, and
108 of the CPSIA regardless of any relief
on third party testing requirements.
3. Description of the Proposed Rule
This proposed rule would create a
new Part 1252 for ‘‘Children’s Products,
Children’s toys, and Child Care Articles:
Determinations Regarding Lead, ASTM
F963 Elements, and Phthalates for
Engineered Wood Products.’’ The
proposed rule would determine that the
specified three EWPs do not contain
lead in concentrations exceeding 100
ppm, any of the ASTM F963 elements
in excess of specified concentrations,
and any of the statutorily prohibited
phthalates (DEHP, DBP, BBP, DINP,
DIDP, DnOP) in concentrations greater
than 0.1 percent. As discussed in
section A.4. of the preamble, the agency
is currently involved in rulemaking to
determine whether to continue the
interim prohibitions in section 108 and
whether to prohibit any other phthalates
in children’s toys or child care articles.
TERA’s examination covered all
phthalates that are subject to the current
permanent and interim prohibitions, as
well as the additional phthalates the
Commission proposed restricting in the
Phthalates NPR. If the Commission
issues a final rule in the phthalates
rulemaking before finalizing this
determinations rulemaking, the final
determinations rule for EPWs would
cover the same phthalates restricted by
the final phthalates rule.
Section 1252.1(a) of the proposed rule
explains the statutorily-created
requirements that limit lead in
children’s products under the CPSIA
and the third party testing requirements
for children’s products.
Section 1252.1(b) of the proposed rule
explains the statutorily-created
requirements for limiting the ASTM
F963 elements in children’s toys under
the CPSIA and the third party testing
requirements for children’s toys.
Section 1252.1(c) of the proposed rule
explains the statutorily-created
requirements limiting phthalates for
children’s toys and child care articles
under the CPSIA and the third party
testing requirements for children’s toys
and child care articles.
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Section 1252.2 of the proposed rule
would provide definitions that apply to
part 1252.
Section 1252.3(a) of the proposed rule
would establish the Commission’s
determinations that specified EWPs do
not exceed the lead content limits with
a high degree of assurance as that term
is defined in 16 CFR part 1107.
Section 1252.3(b) of the proposed rule
would establish the Commission’s
determinations that specified EWPs do
not exceed the solubility limits for
ASTM F963 elements with a high
degree of assurance as that term is
defined in 16 CFR part 1107.
Section 1252.3(c) of the proposed rule
would establish the Commission’s
determinations that specified EWPs do
not exceed the phthalates content limits,
with the exception of hardwood
plywood containing PVAc, with a high
degree of assurance as that term is
defined in 16 CFR part 1107.
Section 1252.3(d) of the proposed rule
states that accessible component parts of
children’s products, children’s toys, and
child care articles made with the
specified EWPs, are not required to be
third party tested pursuant to section
14(a)(2) of the CPSA and 16 CFR part
1107.
Section 1252.3(e) of the proposed rule
states that accessible component parts of
children’s products, children’s toys, and
child care articles that are not
specifically listed in the determinations
in proposed § 1252.3(a) through (c) are
required to be third party tested
pursuant to section 14(a)(2) of the CPSA
and 16 CFR part 1107.
4. Comments on the Proposed Rule
The Commission seeks comments on
all aspects of the proposed rule. In
particular, comments of the following
topics are welcome.
• Are there any data or examples that
indicate that the EWPs identified in the
proposed rule can and do contain lead,
the ASTM F963 elements, or prohibited
phthalates at levels that are not
compliant? Please provide data
supporting your assertion.
• The TERA Task 14 Report
identified the use of some of the ASTM
F963 elements as catalysts in adhesive
formulations used to manufacture
EWPs. Please provide any information
that supports or refutes the claim that
these elements will not be present in
concentrations greater than their
specified limits in EWPs.
• CPSC staff has heard from a
manufacturer of PVAc adhesive
formulations used in the manufacture of
hardwood plywood that, although
phthalates are no longer used in
domestic production, they were once
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used. What phthalates were used in
PVAc in the past? Could any of the
specified phthalates be used? Why or
why not? Are any of the specified
phthalates used in domestic or
international manufacturing of EWPs?
Why or why not?
• How can one determine if a
hardwood plywood sheet contains a
PVAc adhesive system? How can one
determine whether a PVAc adhesive
system used in the manufacture of
hardwood plywood contains a specified
phthalate in concentrations greater than
the specified limits? Can this type of
information be found on labels, SDSs,
company Web sites, or in some other
way?
• Other than PVAc, are there
additional adhesive formulations used
in the manufacture of EWPs that could
contain the specified phthalates in
concentrations greater than those
specified? If yes, what phthalates are
used and at what concentration?
• Are there any post-consumer
recycled EWPs that consistently comply
with the limits for lead, ASTM F963
elements, or prohibited phthalates?
• Please describe the methods used to
determine whether post-consumer
recycled material is used in the
manufacture of EWPs. How can this
type of information be found (on labels,
SDSs, company Web sites, or in some
other way)?
• In addition to particleboard,
hardwood plywood, and mediumdensity fiberboard, are there other EWPs
widely used in children’s products,
children’s toys, and child care articles
that have not been identified in the
proposed rule that do not, and will not,
contain lead, the ASTM F963 elements,
or prohibited phthalates in
concentrations greater than the
mandatory limits? Please provide
supporting data.
E. Effective Date
The Administrative Procedure Act
(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
proposed rule would provide relief from
existing testing requirements under the
CPSIA, the Commission proposes a 30
day effective date for the final rule.
F. Regulatory Flexibility Act
1. Introduction
The Regulatory Flexibility Act (RFA)
requires that agencies review a proposed
rule for the rule’s potential economic
impact on small entities, including
small businesses. Section 603 of the
RFA generally requires that agencies
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prepare an initial regulatory flexibility
analysis (IRFA) and make the analysis
available to the public for comment
when the agency is required to publish
a notice of proposed rulemaking, unless
the agency certifies that the proposed
rule will not have a significant
economic impact on a substantial
number of small entities. The IRFA
must describe the impact of the
proposed rule on small entities and
identify any alternatives which
accomplish the statutory objectives and
may reduce the significant economic
impact of the proposed rule on small
entities. We provide a summary of the
IRFA.
2. Small Entities to Which the Proposed
Rule Would Apply
The proposed rule would apply to
small entities that manufacture or
import children’s products, children’s
toys, and child care articles that contain
particleboard, hardwood plywood, or
medium-density fiberboard. The
number of domestic manufacturers
classified in the North American
Industrial Classification System
(NAICS) categories that could
manufacture children’s products,
children’s toys, or child care articles
that may contain accessible
particleboard, hardwood plywood, or
medium-density fiberboard component
parts and would be responsible for the
certification of these products may
include 7,059 firms that can be
categorized as small.22 Of these, 3,705
have fewer than 5 employees. However,
it is doubtful that all of the firms in
some of these categories produce
children’s products. Moreover, of those
firms that do produce children’s
products, we do not know how many of
the firms manufacture products with
accessible particleboard, hardwood
plywood, or medium-density fiberboard
component parts.
The number of domestic wholesalers
by NAICS code that could distribute
children’s products, children’s toys, or
child care articles that may contain
accessible particleboard, hardwood
plywood, or medium-density fiberboard
component parts may include 26,113
firms that can be categorized as small.
Of these, 15,947 have less than 5
employees. Wholesalers who obtain
their products strictly from domestic
manufacturers or from other wholesalers
would not be impacted by the rule
because the manufacturer or importer
would be responsible for certifying the
products. Although importers are
22 The numbers of small firms for each NAICS
code are from the Census Bureau and generally
based on the SBA criteria for small firms.
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responsible for the certification of the
children’s products that they import,
they may rely upon third party testing
performed by their foreign suppliers for
purposes of certification. The number of
small wholesalers that import children’s
products, children’s toys, or child care
articles as opposed to obtaining their
product from domestic sources is not
known. Also unknown is the number of
small importers that must obtain or pay
for the third party testing of their
products.
The number of domestic retailers by
NAICS code that could sell children’s
products, children’s toys, or child care
articles that may contain accessible
particleboard, hardwood plywood, or
medium-density fiberboard component
parts may include 49,358 firms that can
be categorized as small. Of these, 27,506
have less than 5 employees. Although
there are almost 50,000 retailers in the
NAICS categories, the only retailers that
would be directly impacted by the
proposed rule are those that import
children’s products themselves.
Retailers that obtain all of their products
from domestic manufacturers or
wholesalers will not be directly
impacted by the rule because the
manufacturers or wholesalers would be
responsible for certifying the products.
Although comprehensive estimates of
the number of children’s products,
children’s toys, and child care articles
that contain component parts made
from the specified engineered woods are
not available, there is evidence that
these engineered woods are used in
children’s furniture, sporting
equipment, children’s toys, and some
musical instruments. Based on the
number of domestic toy manufacturers
that are classified as small businesses by
the U.S. Bureau of the Census and
evidence that the specified engineered
woods are used in children’s products,
children’s toys, and child care articles,
the Commission believes a substantial
number of small entities would be
impacted by this regulation.
3. Reporting, Recordkeeping, and Other
Compliance Requirements and Impact
on Small Businesses
The proposed rule would determine
that there is a high degree of assurance
that the certain EWPs be determined not
to contain lead, the ASTM F963
elements, and the specified phthalates
(DEHP, DBP, BBP, DINP, DIDP, or
DnOP) in concentrations greater than
their specified limits. Under this
proposed determination, manufacturers,
importers, and private labelers of
children’s products, children’s toys, and
child care articles that have accessible
component parts that consist of these
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engineered woods would not require
third party testing for certification that
these components comply with the lead,
ASTM F963 elements, or phthalate
requirements.
The proposed rule would not impose
any reporting, recordkeeping, or other
compliance requirements on small
entities. In fact, because the proposed
rule would eliminate a testing
requirement, there would be a small
reduction in some of the recordkeeping
burden under 16 CFR parts 1107 and
1109 because manufacturers would no
longer have to maintain records of third
party tests for the component parts
manufactured from these engineered
woods for lead, the ASTM F963
elements, or the specified phthalates.
The impact of the determinations on
small businesses would be to reduce the
burden of third party testing for the
content of lead, the ASTM F963
elements, and the specified phthalates
and would be expected to be entirely
beneficial. The cost of lead testing
ranges from $50 to more than $100 per
component through Inductively
Coupled Plasma testing (ICP). If one
uses X-ray fluorescence spectrometry
(XRF), which is an acceptable method
for certification of third-party testing for
lead content, the costs can be greatly
reduced to approximately $5 per
component part. If a component part
made with one of the specified
engineered woods is painted, the
component part would be exempt from
the third party testing requirement, but
the paint would still require lead
testing.
Based on published invoices and
price lists, the cost of a third party test
for the ASTM F963 elements ranges
from around $60 in China, up to around
$190 in the United States using ICP.
This cost can be greatly reduced with
the use of high definition X-ray
fluorescence spectrometry (HDXRF),
which is an acceptable method for
certification of third-party testing for the
presence of the ASTM F963 elements.
The cost can be reduced to about $40
per component. It should be noted that
lead is one of the ASTM F963 elements,
so this testing would also cover the cost
of lead testing for component parts.
The cost of phthalate testing is
relatively high: Between about $125 and
$350 per component part, depending
upon where the testing is conducted
and any discounts that are applicable.
Because one product might have
multiple component parts that require
testing, the cost of testing a single
product for phthalates could exceed
$1,000 in some cases. Moreover, more
than one sample might have to be tested
to provide a high degree of assurance of
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compliance with the requirements for
testing. To the extent that small
businesses have lower production or
sales volumes than larger businesses,
these determinations would be expected
to have a disproportionately beneficial
impact on small businesses. This
beneficial impact is due to spreading the
costs of the testing over fewer units; and
the benefit of the Commission making
the determinations would be greater on
a per unit basis for small businesses.
Additionally, some testing laboratories
may offer their larger customers
discounts that might not be available to
small businesses that need fewer third
party tests. Making the determinations
for these engineered woods could
potentially significantly benefit a
substantial number of firms.
On the other hand, the benefit of
making the determinations could be less
than might be expected. For example,
some firms might have been able to
substantially reduce their third party
testing costs by using component part
testing as allowed under 16 CFR 1109,
so the marginal benefit that might be
derived from making the determinations
might be low. Also, some firms have
reduced their testing costs by using XRF
or HDXRF technology, which is less
expensive than ICP, and would reduce
the marginal benefit of these
determinations. The Commission seeks
public comments on the potential
impact of the proposed rule on small
entities. Comments are especially
welcome on the following topics:
• The extent to which particleboard,
hardwood plywood, and mediumdensity fiberboard are used in children’s
products, children’s toys, and child care
articles, especially those manufactured
or imported by small firms;
• The potential reduction in third
party testing costs that might be
provided by the Commission making the
determinations, including the extent to
which component part testing is already
being used and the current cost of
testing components made from these
engineered woods for compliance with
the lead, ASTM F963 elements, and
phthalate requirements;
• Any situations or conditions in the
proposed rule that would make it
difficult to make use of the
determinations to reduce third party
testing costs; and
• Although the Commission expects
that the impact of the proposed rule will
be entirely beneficial, any potential
negative impacts of the proposed rule.
4. Alternatives Considered To Reduce
the Burden on Small Entities
Under section 603(c) of the RFA, an
initial regulatory flexibility analysis
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should ‘‘contain a description of any
significant alternatives to the proposed
rule which accomplish the stated
objectives of the applicable statutes and
which minimize any significant impact
of the proposed rule on small entities.’’
Because the proposed rule is intended
to reduce the cost of third party testing
on small businesses and will not impose
any additional burden, the Commission
did not consider alternatives to the
proposed rule that would reduce the
burden of this rule on small businesses.
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 1252
Business and industry, Consumer
protection, Imports, Infants and
children, Product testing and
certification, Toys.
For the reasons stated in the
preamble, the Commission proposes to
amend title 16 of the CFR to add part
1252 to read as follows:
PART 1252—CHILDREN’S PRODUCTS,
CHILDREN’S TOYS, AND CHILD CARE
ARTICLES: DETERMINATIONS
REGARDING LEAD, ASTM F963
ELEMENTS, AND PHTHALATES FOR
ENGINEERED WOOD PRODUCTS
Sec.
1252.1 Children’s products, children’s toys,
and child care articles containing lead,
ASTM F963 elements, and phthalates in
engineered wood products and testing
requirements.
1252.2 Definitions.
1252.3 Determinations for engineered wood
products.
Authority: Sec. 3, Pub. L. 110–314, 122
Stat. 3016; 15 U.S.C. 2063(d)(3)(B).
§ 1252.1 Children’s products, children’s
toys, and child care articles containing lead,
ASTM F963 elements, and phthalates in
engineered wood products and testing
requirements.
(a) Section 101(a) of the Consumer
Product Safety Improvement Act of
2008 (CPSIA) provides that any
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children’s product, material, or
component part or a children’s product
must comply with a lead content limit
that does not exceed 100 parts per
million. Materials used in children’s
products subject to section 101 of the
CPSIA must comply with the third party
testing requirements of section 14(a)(2)
of the Consumer Product Safety Act
(CPSA), unless listed in 16 CFR 1500.91.
(b) Section 106 of the CPSIA made
provisions of ASTM F963, Consumer
Product Safety Specifications for Toy
Safety, 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
children’s toys that can be sucked,
mouthed, or ingested, must comply with
solubility limits that the toy standard
establishes for eight elements. Materials
used in children’s 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
CPSA, unless listed in 16 CFR 1251.2.
(c) Section 108(a) of the CPSIA
permanently prohibits any children’s
toy or child care article that contains
concentrations of more than 0.1 percent
of di-(2-ethylhexl) phthalate (DEHP),
dibutyl phthalate (DBP), or benzyl butyl
phthalate (BBP). Section 108(b)(1) of the
CPSIA prohibits on an interim basis any
children’s toy that can be placed in a
child’s mouth or child care article that
contains concentrations of more than
0.1 percent of diisononyl phthalate
(DINP), diisodecyl phthalate (DIDP), or
di-n-octyl phthalate (DnOP). Materials
used in children’s toys and child care
articles subject to section 108(a) and
(b)(1) of the CPSIA must comply with
the third party testing requirements of
section 14(a)(2) of the CPSA, unless
listed in 16 CFR part 1308.
§ 1252.2
Definitions.
In addition to the definitions given in
sections 101, 106, and 108 of the CPSIA,
the following definitions apply for this
part 1252.
(a) Post-consumer wood waste
describes wood waste that is comprised
of materials that are recovered from
their original use and subsequently used
in a new product. Examples of this type
of waste include recycled demolition
wood, packaging materials such as
pallets and crates, used wood from
landscape care (i.e., from urban and
highway trees, hedges, and gardens),
discarded furniture, and waste wood
from industrial, construction, and
commercial activities.
(b) Pre-consumer wood waste
describes wood materials that have been
recycled from an industrial process
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before being made available for
consumer use. Examples of this type of
waste include trimmings from
engineered wood product (EWP) panel
manufacturing, sawdust from cutting
logs, or remaining wood pieces from
sawing a log into framing lumber.
(c) Unfinished means an EWP that
does not have any surface treatments
applied at manufacture, such as factoryapplied coatings. Examples of such
treatments may include paint or similar
surface coating materials, wood glue, or
metal fasteners, such as nails or screws.
(d) Untreated means an EWP that
does not have any additional finishes
applied at manufacture. Examples of
such finishes may include flame
retardants or rot resistant finishes.
(e) Virgin wood describes wood logs,
fibers, chips, or layers that have not
been recycled from a previous use.
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§ 1252.3 Determinations for engineered
wood products.
(a) The following engineered wood
products do not exceed the lead content
limits with a high degree of assurance
as that term is defined in 16 CFR part
1107:
(i) Particleboard that is untreated and
unfinished made from virgin wood or
pre-consumer wood waste;
(ii) Hardwood plywood that is
untreated and unfinished made from
virgin wood or pre-consumer wood
waste; and
(iii) Medium-density fiberboard that is
untreated and unfinished made from
virgin wood or pre-consumer wood
waste.
(b) The following engineered wood
products do not exceed the ASTM F963
elements solubility limits set forth in 16
CFR part 1250 with a high degree of
assurance as that term is defined in 16
CFR part 1107:
(i) Particleboard that is untreated and
unfinished made from virgin wood or
pre-consumer wood waste;
(ii) Hardwood plywood that is
untreated and unfinished made from
virgin wood or pre-consumer wood
waste; and
(iii) Medium-density fiberboard that is
untreated and unfinished made from
virgin wood or pre-consumer wood
waste.
(c) The following engineered wood
products do not exceed the phthalates
content limits with a high degree of
assurance as that term is defined in 16
CFR part 1107:
(i) Particleboard that is untreated and
unfinished made from virgin wood or
pre-consumer wood waste;
(ii) Hardwood plywood that is
untreated and unfinished made from
virgin wood or pre-consumer wood
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waste and does not contain PVAc
adhesive formulations; and
(iii) Medium-density fiberboard that is
untreated and unfinished made from
virgin wood or pre-consumer wood
waste.
(d) Accessible component parts of
children’s products, children’s toys, and
child care articles made with EWPs,
listed in paragraphs (a) through (c) of
this section are not required to be third
party tested pursuant to section 14(a)(2)
of the CPSA and 16 CFR part 1107.
(e) Accessible component parts of
children’s products, children’s toys, and
child care articles made with engineered
wood products not listed in paragraphs
(a)–(c) of this section are required to be
third party tested pursuant to section
14(a)(2) of the CPSA and 16 CFR part
1107.
Alberta E. Mills,
Acting Secretary, Consumer Product Safety
Commission.
[FR Doc. 2017–21980 Filed 10–12–17; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 112
[Docket No. FDA–2011–N–0921]
RIN 0910–ZA50
Standards for the Growing, Harvesting,
Packing, and Holding of Produce for
Human Consumption; Extension of
Compliance Dates for Subpart E;
Correction
AGENCY:
Food and Drug Administration,
[FR Doc. 2017–22182 Filed 10–12–17; 8:45 am]
Proposed rule; correction.
The Food and Drug
Administration (FDA, the Agency, or
we) is correcting a proposed rule that
published in the Federal Register of
September 13, 2017. That proposed rule
proposes to extend, for covered produce
other than sprouts, the dates for
compliance with the agricultural water
provisions in the ‘‘Standards for the
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption’’ regulation. We are
placing a corrected copy of the proposed
rule in the docket.
DATES: October 13, 2017.
FOR FURTHER INFORMATION CONTACT:
Samir Assar, Center for Food Safety and
Applied Nutrition (HFS–317), Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1636.
SUMMARY:
PO 00000
Dated: October 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
BILLING CODE 4164–01–P
HHS.
ACTION:
In the
Federal Register of September 13, 2017
(82 FR 42963), FDA published the
proposed rule ‘‘Standards for the
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption; Extension of Compliance
Dates for Subpart E’’ with an omission.
In FR Doc. 2017–19434, appearing on
page 42963 in the Federal Register of
September 13, 2017, the following
correction is made:
On page 42967, in the third column,
the paragraph above the table is
corrected to include the fourth sentence
as follows: ‘‘There would be a reduction
in benefits associated with extending
the compliance dates as described
previously. Consumers eating nonsprout covered produce would not enjoy
the potential health benefits (i.e.,
reduced risk of illness) provided by the
provisions of subpart E until 2 to 4 years
(depending on the specific provision)
later than originally established in the
produce safety regulation. Thus, the
annualized total benefits to consumers,
discounted at 3 percent over 10 years,
would decrease by $108 million from
$1.033 billion to $925 million. Taking
into consideration both the reduction in
costs and the reduction in benefits,
using a 3 (7) percent discount rate, the
proposed rule would have negative
annualized net benefits of $96 ($97)
million. Estimated changes in benefits
and costs as a result of this proposed
extension are summarized in the
following table.’’
SUPPLEMENTARY INFORMATION:
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 54
[REG–129631–17]
RIN 1545–BN91
Moral Exemptions and
Accommodations for Coverage of
Certain Preventive Services Under the
Affordable Care Act; Proposed
Rulemaking
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
by cross-reference to temporary
regulations.
AGENCY:
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Agencies
[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Proposed Rules]
[Pages 47645-47656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21980]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1252
[Docket No. CPSC-2017-0038]
Children's Products, Children's Toys, and Child Care Articles:
Determinations Regarding Lead, ASTM F963 Elements, and Phthalates for
Engineered Wood Products
AGENCY: U.S. Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Consumer Product Safety Commission (Commission, or CPSC)
is proposing a rule to determine that certain untreated and unfinished
engineered wood products (EWPs), specifically, particleboard, hardwood
plywood, and medium-density fiberboard, made from virgin wood or pre-
consumer waste wood would not contain lead, the ASTM F963 elements, or
specified phthalates that exceed the limits set forth under the CPSC's
statutes for children's products, children's toys, and child care
articles. Based on these proposed determinations, the specified EWPs
would not be required to have third party testing for compliance with
the requirements for lead, ASTM F963 elements, or phthalates for
children's products, children's toys, and child care articles.
DATES: Submit comments by December 27, 2017.
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2017-
0038, by any of the following methods:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: https://www.regulations.gov. Follow the
instructions for submitting comments. The Commission does not accept
comments submitted by electronic mail (email), except through
regulations.gov. The Commission encourages you to submit electronic
comments by using the Federal eRulemaking Portal, as described above.
Written Submissions: Submit written comments 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. All comments received may be posted without change,
including any personal identifiers, contact information, or other
personal information provided, to: https://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 by mail/hand delivery/courier.
FOR FURTHER INFORMATION CONTACT: Jacqueline Campbell, Senior Textile
Technologist, Office of Hazard Identification and Reduction, U.S.
Consumer Product Safety Commission, 5 Research Place, Rockville, MD
20850: Telephone 301-987-2024; email: jcampbell@cpsc.gov.
[[Page 47646]]
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,
children's toys, and child care articles, 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).
To provide opportunities to reduce the cost of third party testing
requirements consistent with assuring compliance with any applicable
consumer product safety rule, ban, standard, or regulations, the CPSC
assessed whether children's products, children's toys, and child care
articles manufactured with three engineered wood products,
specifically, particleboard, hardwood plywood, and medium-density
fiberboard (collectively referred to as EWPs), would comply with CPSC's
requirements for lead, ASTM F963 elements or phthalates. If the
Commission determines that such materials 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 testing laboratory to
issue a Children's Product Certificate (CPC).
2. CPSC's Lead Standard
Section 101 of the CPSIA has two requirements associated with lead
in children's products. 15 U.S.C. 1278a. First, no accessible part of a
children's product may contain more than 100 parts per million (ppm)
lead content. Second, paint or other surface coatings on children's
products and furniture intended for consumer use may not contain lead
in concentrations greater than 90 ppm. Manufacturers of children's
products must certify, based on third party testing, that their
products comply with all relevant children's product safety rules.
Thus, products subject to the lead content or paint/surface coating
limits require passing test results from a CPSC-accepted third party
laboratory for the manufacturer to issue a CPC, before the products can
be entered into commerce.
To alleviate some of the third testing burdens associated with lead
in the accessible component parts of children's products, the
Commission determined that certain materials, including gemstones,
precious metals, wood, paper, CMYK process printing inks, textiles, and
specified stainless steel, do not exceed the 100 ppm lead content limit
under section 101 of the CPSIA. Based on this determination, such
materials do not require third party testing for the lead content
limits. The determinations regarding lead content for certain materials
are set forth in 16 CFR 1500.91.
3. ASTM F963 Elements
Section 106 of the CPSIA provides that the provisions of ASTM
International, Consumer Safety Specifications for Toy Safety (ASTM
F963), shall be considered to be consumer product safety standards
issued by the Commission.\1\ 15 U.S.C. 2056b. The Commission has issued
a rule that incorporates by reference the relevant provisions of ASTM
F963. 16 CFR part 1250. Thus, children's toys subject to ASTM F963 must
be tested by a CPSC-accepted third party laboratory and demonstrate
compliance with all applicable CPSC requirements for the manufacturer
to issue a CPC before the children's toys can be entered into commerce.
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\1\ ASTM F963 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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Section 4.3.5 of ASTM F963 requires that surface coating materials
and accessible substrates of children's toys that can be sucked,
mouthed, or ingested \2\ must comply with the solubility limits of
eight elements given in Table 1 of the toy standard. The materials and
their solubility limits are shown in Table 1. We refer to these eight
elements as ``ASTM F963 elements.''
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\2\ ASTM F963 contains the following note regarding the scope of
the solubility requirement: NOTE 4--For the purposes of this
requirement, the following criteria are considered reasonably
appropriate for the classification of children's 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 children's
toys which are cosmetics, and components of writing instruments
categorized as children's toys; (2) Children's 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.
Table 1--Maximum Soluble Migrated Element in ppm (mg/kg) for Surface
Coatings and Substrates Included as Part of a Toy
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Elements Solubility limit, (ppm) \3\
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Antimony (Sb)............................. 60
Arsenic (As).............................. 25
Barium (Ba)............................... 1,000
Cadmium (Cd).............................. 75
Chromium (Cr)............................. 60
Lead (Pb)................................. 90
Mercury (Hg).............................. 60
Selenium (Se)............................. 500
------------------------------------------------------------------------
The third party testing burden could be reduced only if all
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 F963 elements, no testing
burden reduction would be achieved if any one of the elements requires
testing.
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\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. Modeling clays included as part of a
toy have different solubility limits for several of the elements.
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To alleviate some of the third testing burdens associated with the
ASTM F963 elements in the accessible component parts of children's
toys, the Commission determined that certain unfinished and untreated
trunk wood does not contain ASTM F963 elements that would exceed the
limits specified in section 106 of the CPSIA. Based on this
determination, unfinished and untreated trunk wood would not require
third party testing for the ASTM F963 elements. The determinations
regarding the ASTM F963 elements limits for certain materials is set
forth in 16 CFR 1251.2.
4. Phthalates
Section 108(a) of the CPSIA permanently prohibits the manufacture
for sale, offer for sale, distribution in commerce, or importation into
the United States of any ``children's toy or child care article'' that
contains concentrations of more than 0.1 percent of di(2-ethylhexyl)
phthalate (DEHP), dibutyl phthalate (DBP), or butyl benzyl
[[Page 47647]]
phthalate (BBP). 15 U.S.C. 2057c(a). Section 108(b)(1) prohibits on an
interim basis (i.e., until the Commission promulgates a final rule),
the manufacture for sale, offer for sale, distribution in commerce, or
importation into the United States of ``any children's toy that can be
placed in a child's mouth'' or ``child care article'' containing
concentrations of more than 0.1 percent of diisononyl phthalate (DINP),
diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP). 15 U.S.C.
2057c(b)(1). Children's toys and child care articles subject to the
content limits in section 108 of the CPSIA require third party testing
for compliance with the phthalate content limits before the
manufacturer can issue a CPC and enter the children's toys or child
care articles into commerce.
The CPSIA required the Commission to appoint a Chronic Hazard
Advisory Panel (CHAP) to ``study the effects on children's health of
all phthalates and phthalate alternatives as used in children's toys
and child care articles.'' 15 U.S.C. 2057c(b)(2). The CHAP issued its
report in July 2014.\4\ Based on the CHAP report, the Commission
published a notice of proposed rulemaking (Phthalates NPR),\5\
proposing to permanently prohibit children's toys and child care
articles containing concentrations of more than 0.1 percent of DINP,
and proposing to lift the interim statutory prohibitions with respect
to DIDP and DnOP. In addition, the Phthalates NPR proposed adding four
new phthalates, DIBP, DPENP, DHEXP, and DCHP, to the list of phthalates
that cannot exceed 0.1 percent concentration in accessible component
parts of children's toys and child care articles. The Commission has
not finalized its proposal on phthalates in children's toys and child
care articles.
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\4\ https://www.cpsc.gov/PageFiles/169902/CHAP-REPORT-With-Appendices.pdf.
\5\ https://www.federalregister.gov/articles/2014/12/30/2014-29967/prohibition-of-children's-toys-and-child-care-articles-
containing-specified-phthalates.
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Tests for phthalate concentration are among the most expensive
certification tests to conduct on a product, and each accessible
component part subject to section 108 of the CPSIA must be tested.\6\
Third party testing burden reductions can occur only if each
phthalate's concentration is below 0.1 percent (1000 ppm). Because
laboratories typically run one test for all of the specified
phthalates, no testing burden reduction likely is achieved if any one
of the phthalates requires compliance testing.
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\6\ Test costs for the content of all the specified phthalates
have been reported to range from $125 to $350 per component,
depending upon where the tests are conducted and any discounts that
might apply.
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To alleviate some of the third testing burdens associated with
plastics in the accessible component parts of children's toys and child
care articles, the Commission determined that products made with
general purpose polystyrene (GPPS), medium-impact polystyrene (MIPS),
high-impact polystyrene (HIPS), and super high-impact polystyrene
(SHIPS) with specified additives do not exceed the phthalates content
limits under section 108 of the CPSIA. 82 FR 41163 (August 30, 2017).
Based on this determination, materials used in children's toys and
child care articles that use these specified plastics and additives
would not require third party testing for the phthalates content
limits. The plastics determinations are set forth in the Commission's
regulations at 16 CFR part 1308.
The research that provides the basis for the phthalates
determination covers the six phthalates subject to the statutory
prohibition and the additional phthalates that the Commission proposed
to prohibit from use in children's toys and child care articles. After
the Commission finalizes its phthalates rule, the Commission will
revise its phthalate determination rule to reflect the phthalates
restricted by the final phthalates rule.
B. Contractor's Research
CPSC contracted with the Toxicology Excellence for Risk Assessment
(TERA) \7\ who authored literature review reports on the content issues
related to certain natural materials, plastics, and EWPs. The following
reports produced by TERA formed the basis for the proposed EWP
determinations: Task 9, Concentrations of Selected Elements in
Unfinished Wood and Other Natural Materials; Task 11, Exposure
Assessment: Composition, Production, and Use of Phthalates; and Task
14, Final Report for CPSC Task 14, which summarized the available
information on the production of the EWPs. Each report is discussed
below.
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\7\ After conducting the contract reports for the CPSC, TERA
reorganized as the Risk Science Center at the University of
Cincinnati: https://med.uc.edu/eh/centers/rsc.
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1. TERA Task 9 Report
In the Task 9 Report, TERA conducted a literature search on whether
unfinished wood and other natural materials could be determined not to
contain any of the ASTM F963 elements in concentrations greater than
the ASTM F963 solubility limits.\8\ The materials researched included
unfinished woods (ash, beech, birch, cherry, maple, oak, pine, poplar,
and walnut); bamboo; beeswax; undyed and unfinished fibers and textiles
(cotton, wool, linen, and silk); and uncoated or coated paper (wood or
other cellulosic fiber).
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\8\ https://www.cpsc.gov/Global/Research-and-Statistics/TechnicalReports/Toys/TERAReportASTMElements.pdf.
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To assess the presence of the ASTM F963 elements' concentrations in
the materials, TERA looked at several factors. The factors reviewed
included 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 ASTM F963 elements into the material under study;
and the potential for contamination after production, such as through
packaging. From this report, the Commission determined that untreated
and unfinished woods from tree trunks do not contain any of the
elements in ASTM F963 in concentrations greater than their respective
solubility limits, and thus, they are not required to be third party
tested to ensure compliance with the specified solubility test.\9\ TERA
relied on this information in TERA Task Report 14 to determine that the
virgin wood material used in the manufacture of EWPs does not, and will
not, contain any of the elements in ASTM F963 in concentrations greater
than their respective solubility limits.
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\9\ 80 FR 78651 (Dec. 17, 2015).
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2. TERA Task 11 Report
In the Task 11 Report, TERA conducted a literature search on the
production and use of 11 specified phthalates in consumer products.\10\
The 11 phthalates researched by TERA were based on the recommendations
made in the CHAP report. Table 2 lists the phthalates researched by
TERA. TERA's research focused on the following factors:
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\10\ https://www.cpsc.gov//Global/Research-and-Statistics/Technical-Reports/Other%20Technical%20Reports/TERAReportPhthalates.pdf.
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The raw materials used in the production of the specified
phthalates;
The manufacturing processes used worldwide to produce the
specified phthalates;
Estimated annual production of the specified phthalates;
Physical properties of the specified phthalates (e.g.,
vapor pressure, flashpoint, water solubility, temperature at which
chemical breakdown occurs);
[[Page 47648]]
Applications for phthalates use in materials and consumer
and non-consumer products; and
Other potential routes by which phthalates can be
introduced into an otherwise phthalates-free material (e.g., migration
from packaging, recycling, reuse, product breakdown).
Table 2--Phthalates Researched in the Task 11 Report
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Phthalate CASRN \11\
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DEHP: di-(2-ethylhexyl) phthalate 117-81-7
DBP: dibutyl phthalate........... 84-74-2
BBP: benzyl butyl phthalate...... 85-68-7
DINP: diisononyl phthalate....... 28553-12-0, 68515-48-0
DIDP: diisodecyl phthalate....... 26761-40-0, 68515-49-1
DnOP: di-n-octyl phthalate....... 117-84-0
DIOP: diisooctyl phthalate....... 27554-26-3
DIBP: diisobutyl phthalate....... 84-69-5
DPENP: di-n-pentyl phthalate..... 131-18-0
DHEXP: di-n-hexyl phthalate...... 84-75-3
DCHP: dicyclohexyl phthalate..... 84-61-7
------------------------------------------------------------------------
TERA found that phthalates are used generally as plasticizers or
softeners of certain plastics, primarily polyvinyl chloride (PVC), as
solvents, and as component parts of inks, paints, adhesives, and
sealants.
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\11\ A CAS Registry Number is assigned to a substance when it
enters the CAS REGISTRY database. https://www.cas.org/content/chemical-substances/faqs.
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3. TERA Task 14 Report
In the Task 14 Report, TERA conducted a literature search on the
production of three EWPs: Particleboard, hardwood plywood, and medium-
density fiberboard.\12\ TERA first researched authoritative sources,
such as reference books and textbooks, along with Internet resources,
for general information about EWPs, adhesives, raw materials,
manufacturing processes, and the potential use of recycled materials.
TERA used this information and consulted technical experts to identify
key words for searching the literature. These key words were then used
to conduct primary literature searches for research studies and
publications. In addition, TERA searched for Safety Data Sheets (SDS)
for information on raw materials. TERA researched the possibility of
the raw materials or finished products in the three EWPs to contain:
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\12\ https://www.cpsc.gov/s3fs-public/ManufacturedWoodsTERATask14Report.pdf.
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Lead in concentrations exceeding 100 ppm;
Any of the specified elements that are included in the
safety standard for children's toys, ASTM F963, Standard Consumer
Safety Specification for Toy Safety, in concentrations exceeding
specified solubility limits; or
Any of 10 specified phthalates in concentrations greater
than 0.1 percent (1000 ppm), listed in Table 3.\13\
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\13\ The TERA research providing the basis for this
determination covers the six phthalates subject to the statutory
prohibition, as well as the additional phthalates the Commission
proposed to prohibit in children's toys and child care articles. The
phthalates determination lists only the six phthalates subject to
the statutory prohibition. However, when the Commission issues a
final rule for the specified phthalates in children's toys and child
care articles, the Commission could revise the phthalates
determination, if needed.
Table 3--Phthalates Researched in the Task 14 Report \14\
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Phthalate CASRN
------------------------------------------------------------------------
DEHP: di-(2-ethylhexyl) phthalate 117-81-7
DBP: dibutyl phthalate........... 84-74-2
BBP: benzyl butyl phthalate...... 85-68-7
DINP: diisononyl phthalate....... 28553-12-0, 68515-48-0
DIDP: diisodecyl phthalate....... 26761-40-0, 68515-49-1
DnOP: di-n-octyl phthalate....... 117-84-0
DIBP: diisobutyl phthalate....... 84-69-5
DPENP: di-n-pentyl phthalate..... 131-18-0
DHEXP: di-n-hexyl phthalate...... 84-75-3
DCHP: dicyclohexyl phthalate..... 84-61-7
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TERA found that, generally, the processes for manufacturing the
three EWPs are similar; wood fibers, chips, layers, or a similar raw
wood product are processed with various adhesive formulations
(sometimes referred to as binders or resins) along with other additives
to create uniform sheets with known characteristics and performance
qualities. The main difference among the three types of EWPs relates
primarily to the size and morphology (shape and surface
characteristics) of the wood material used in their production.
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\14\ While included in the Task 11 Report, DIOP was not included
in the Task 14 Report because the ban on DIOP was proposed to be
removed in the Phthalates NPR.
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TERA reviewed the literature to assess whether the specified EWPs
might contain lead or one or more of the other elements at levels that
exceed the ASTM solubility limits, or any of the specified phthalates
in concentrations greater than the specified limits. TERA reported that
no studies found lead, the ASTM F963 elements, or the specified
phthalates in concentrations greater than their limits in
particleboard, hardwood plywood, or medium-density fiberboard, that are
unfinished and untreated, and made from virgin wood or pre-consumer
wood waste.
In the Task 14 Report, TERA described an unfinished EWP as one that
does not have any surface treatments applied at manufacture, such
[[Page 47649]]
as factory-applied coatings. An untreated EWP is one that does not have
any additional finishes applied at manufacture such as flame retardants
or rot resistant finishes. TERA described virgin wood as wood logs,
fibers, chips, or layers that have not been recycled from a previous
use. TERA described pre-consumer wood waste as wood materials that have
been recycled from an industrial process before being made available
for consumer use. Examples of this type of waste include trimmings from
EWP panel manufacturing, sawdust from cutting logs, or remaining wood
pieces from sawing a log into framing lumber.
The TERA report highlighted the potential for lead, the ASTM F963
elements, or the specified phthalates to be present in concentrations
greater than those specified through the use of contaminated recycled
material in EWPs made from recycled wood waste or EWPs that have post-
manufacturing treatments or finishes. Recycled wood waste may be made
from reclaimed or post-consumer wood waste. Post-consumer wood waste is
described as wood waste that is comprised of materials that are
recovered from their original use and subsequently used in a new
product. Examples of this type of waste include recycled demolition
wood, packaging materials such as pallets and crates, used wood from
landscape care (i.e., from urban and highway trees, hedges, and
gardens), discarded furniture, and waste wood from industrial,
construction, and commercial activities.
The three types of EWPs reviewed by TERA are discussed below.
a. Particleboard
Particleboard is a composite of wood chips, adhesives, and other
additives pressed into a board. Adhesive formulations are used to bond
wood chips, which are then formed into mats that are layered to create
uniform boards in a range of dimensions. Particleboard is used widely
in furniture making and other interior (or nonstructural) uses. The
constituent parts of particleboard reported by TERA can include (by
weight):
Wood (60-99+ percent);
Adhesive formulation (0-17 percent, with 5-11 percent most
common)
May include phenol-formaldehyde (uncommon but potential
for use), urea-formaldehyde, melamine-urea-formaldehyde, polymeric
methylene-diphenyl-diisocyanate (pMDI);
Waxes (0.3-1 percent);
Other additives (up to 2 percent); or
Scavengers or additional unspecified materials.
TERA researched the possibility of lead, the ASTM F963 elements, or
the specified phthalates, in concentrations greater than their
specified limits in particleboard. TERA identified little information
on measurements of lead and the ASTM F963 elements in particleboard and
no studies that measured the specified phthalates. TERA identified two
references where particleboard made from both untreated and copper
chromate arsenic-(CCA) treated wood chips was tested. Arsenic and
chromium were undetected in the particleboards made from virgin wood
chips. However, the particleboard composed of 25 percent wood chips
from reclaimed CCA-treated wood products contained 895 and 832 ppm of
arsenic and chromium, respectively, without adversely affecting the
mechanical performance of the board. Another study that discussed
``recycled particleboard'' was identified as wood waste obtained from a
wood recycling plant.
Apart from the studies on particleboard made from wood waste that
may contain post-consumer wood waste or post-manufacturing treatments,
TERA reported that no studies found lead, the ASTM F963 elements, or
the specified phthalates in concentrations greater than the specified
limits in untreated and unfinished particleboard.
b. Hardwood Plywood
Plywood is a layered board of wood veneers where the layers have
alternating, perpendicular wood grain directions. Less commonly, the
board might have a core of other EWPs with wood veneers as the outer
layers. Hardwood plywood, addressed in this report, is a type of
plywood that is composed of angiosperms (i.e., ``hardwoods,'' such as
oak or maple) and used primarily in furniture and other interior
(nonstructural) uses, as well as in playground equipment, sports
equipment, and musical instruments. The constituent parts of hardwood
plywood reported by TERA can include (by weight):
Wood (75-99+ percent);
Adhesive formulation (0.02-20 percent, with 1 percent to 5
percent most common)
May include phenol-formaldehyde or phenol-resorcinol-
formaldehyde (likely for use in structural plywood but potential for
application to hardwood plywood), urea-formaldehyde, melamine-
formaldehyde, or melamine-urea-formaldehyde, or polyvinyl acetate
(PVAc); or
Other additives (less than 2 percent).
TERA researched the possibility of lead, the ASTM F963 elements, or
the specified phthalates in concentrations greater than those specified
in hardwood plywood. TERA identified only one study that measured lead
and the ASTM F963 elements in plywood and no studies that measured the
specified phthalates. Concentrations of cadmium, chromium, and lead,
were all less than the solubility limits, in ``plain'' plywood. In
addition, because hardwood plywood is made from sheets of wood veneer,
it is less likely to contain recycled wood content, unless it
incorporates a core of some other EWP, such as particleboard or medium-
density fiberboard.
Aside from the studies on recycled wood waste that may contain
post-consumer wood waste or post-manufacturing treatments in a
particleboard, medium-density fiberboard, or other EWP core, TERA
reported that no studies found lead, the ASTM F963 elements, or the
specified phthalates in concentrations greater than the specified
limits in untreated and unfinished hardwood plywood. However, TERA
identified research which indicated that polyvinyl acetate (PVAc) can
be used as an adhesive system for hardwood plywood as discussed in
section (d) below.
c. Medium-Density Fiberboard
Medium-density fiberboard (MDF) is a composite of wood fibers, an
adhesive formulation, and other additives pressed into a board. MDF is
a similar product to particleboard, differing mostly due to the use of
fiber rather than chips. It is used primarily in furniture and other
interior (nonstructural) uses. The constituent parts of MDF reported by
TERA can include (by weight):
Wood (73-99+ percent);
Adhesive formulation (0-25 percent with most common 5-12
percent);
May include phenol-formaldehyde (uncommon, but potentially
used for moisture resistance), urea-formaldehyde (most commonly
identified), methylene-diphenyl-diisocyanate (pMDI), melamine-
formaldehyde, or melamine-urea-formaldehyde;
Waxes (less than 1 percent); or
Other additives (10-30 percent).
TERA researched the possibility of lead, the ASTM F963 elements, or
the specified phthalates in concentrations greater than those specified
in MDF. TERA did not identify any references that reported the presence
of lead, the ASTM F963 elements, or the specified phthalates in MDF
made with virgin wood.
[[Page 47650]]
Aside from the studies on recycled wood waste that may contain
post-consumer wood waste or post-manufacturing treatments, TERA
reported that no studies found lead, the ASTM F963 elements, or the
specified phthalates in concentrations greater than the specified
limits in untreated and unfinished MDF.
d. TERA's Findings on EWP Constituent Parts
Because few references were found directly addressing lead, the
ASTM F963 elements, and the specified phthalates in EWPs, TERA also
researched the constituent parts that could be used to manufacture
EWPs, including wood and adhesives.
Wood
According to the manufacturing process information provided by
TERA, virgin wood and wood residues are the main source of wood fiber
used in North America to manufacture EWPs. Typically, these sources
include low value logs, industrial wood residues, or scraps and trim
from furniture and EWP production. For example, hardwood plywood
requires the trunks of trees to obtain the thin layers of veneer used
to construct a sheet. TERA relied on the Task 9 Report and Commission
findings on unfinished and untreated wood (80 FR 78651 (Dec. 17, 2015))
to determine that untreated and unfinished wood from the trunks of
trees do not contain lead or the ASTM F963 elements in concentrations
greater than the specified solubility limits. TERA also noted that,
although phthalates can be taken up by trees and plants, the
concentrations are negligible and less than the specified limit (0.1
percent).
Although TERA reported that the majority of EWPs are manufactured
with virgin wood or pre-consumer wood waste fiber or chips, the wood
component also can originate from recycled material. For EWPs made from
recycled wood waste that may contain post-consumer wood waste, the TERA
report highlighted the potential for lead, the ASTM F963 elements, or
the specified phthalates to be present in concentrations greater than
those specified through the use of contaminated recycled material. The
TERA report cited multiple examples of the use of reclaimed or post-
consumer wood material used to produce EWPs, both domestically and
internationally. Specifically, TERA found studies showing that
reclaimed lumber and wood waste could contain a myriad of contaminants,
such as surface treatments (e.g., paints, stains), metals, glues and
adhesives, glass, paper, plastic, rubber and chemical treatments.
Metals and organic materials may be present in paints, stains,
varnishes, and polishes that are used on wood products (e.g.,
furniture, window frames) and nails, screws, and other metal hardware
might be attached to the recycled and recovered wood. These
contaminants are intimately attached to the wood, and therefore, some
contaminants may pass through cleaning systems, contaminating the
entire recovered wood stream.
TERA also reviewed another study, based in Italy that evaluated the
``recyclability'' of used wood by conducting elemental analysis of wood
residues from wood recycling plants using a handheld fast energy
dispersive X-ray fluorescence spectroscopy (ED-XRF) device. TERA found
that the study provided some indication of types and levels of
contamination in various kinds of post-consumer wood waste. Elemental
analysis results were compared to EU Community Ecolabel limits.\15\ For
all wood products tested, 16 percent exceeded one or more of the
Ecolabel limits, with the highest concentrations from lead, chromium,
chlorine, copper, cadmium, and mercury. No samples had levels of
arsenic over the 25 ppm limit (except a CCA-treated utility pole).
Barium and lead were found in 10 percent to 20 percent of the samples,
chromium and cadmium in 3 percent to 4 percent, and antimony, mercury,
and arsenic ranged from 0.3 percent to 1.2 percent of samples. The
sources most contaminated with non-wood content were from furniture and
building materials, while pallets and shipping containers were least
likely to be contaminated.\16\
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\15\ Ecolabel element concentrations are less than 25 mg/kg of
arsenic, 25 mg/kg of mercury, 25 mg/kg of chromium, 50 mg/kg
cadmium, 90 mg/kg lead, and 40 mg/kg copper (EU, 2004). Ecolabel
limits are similar to ASTM solubility limits for the ASTM F963
elements.
\16\ Twenty-four percent of furniture and 18 percent of building
materials had one or more ASTM F963 elements exceeding the limits
which may be due to manufacturing processes such as painting,
preservation, and overlaying, which are common with furniture and
building materials. The most polluted types of wood waste were
particleboard (37% exceeded Ecolabel limits), recycled particleboard
(25% exceeded), and plywood (18% exceeded); while fiberboard (MDF
and HDF) exceeded limits in 9 percent of samples.
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TERA concluded that, with an increased interest and use of post-
consumer recycled materials in EWP production, potential contamination
by the specified elements and phthalates must be considered. To ensure
that EWPs made from used wood fibers do not contain ASTM F963 elements
or phthalates the exceed the specified limits, TERA indicated that the
materials would need to be sorted carefully and tested to be assured
that they are not contaminated.
Adhesive Formulations
Adhesive formulations hold the wood chips, layers, or fibers
together to make EWP mats and sheets. Some of the formulations use a
metal catalyst during the curing process. TERA identified a number of
references describing the presence of the ASTM F963 elements in
adhesive formulations. However, TERA found very few references that
would implicate EWPs. Although the use of barium was noted in multiple
references, only one study appeared to be relevant to EWPs. This study
suggested that barium, when used as a catalyst in an adhesive, could
result in an EWP that exceeded the ASTM solubility level for
barium.\17\ However, this method does not appear to be used currently
in EWP production. TERA also noted studies that indicate the possible
use of chromium as a catalyst in phenol formaldehyde resin as well as
the possible use of antimony or arsenic in a drier formulation for
certain polymeric coatings. However, no references included information
on concentrations or appeared relevant to EWPs.
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\17\ Wang and Zhang (2011) studied the use of calcium hydroxide,
Ba(OH)2, and magnesium hydroxide and their effect on cure
times for phenol formaldehyde adhesive formulations, finding that
the use of Ba(OH)2 could be a viable means to speed up
cure times. Both calcium hydroxide and Ba(OH)2 had
similar cure times and are about the same price in bulk. Because the
compounds would be used in an adhesive system, the catalyst is not
expected to be recovered and so would remain in situ once curing is
complete. If the catalyst remained in the adhesive, it could result
in concentrations of barium exceeding the ASTM solubility limits.
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Although many different adhesive formulations may be used in
hardwood plywood, TERA noted that PVAc can be used as an adhesive
system for hardwood plywood. The report cited sources (The Handbook of
Adhesive Technology, USDA) that mentioned the use of some of the
specified phthalates in PVAc adhesive formulations.\18\ TERA also
identified research papers which included the use of DBP and DEHP in
PVAc at concentrations greater than 0.1 percent.
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\18\ The USDA publication Wood Handbook: Wood as an Engineering
Material (2010) explains that ``Plasticizers, for example dibutyl
phthalate, are used to soften the brittle vinyl acetate homopolymer
in poly(vinyl acetate) emulsion adhesives. This is necessary to
facilitate adhesive spreading and formation of a flexible adhesive
film from the emulsion at and below room temperature.''
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[[Page 47651]]
C. CPSC Staff Analysis of TERA Reports
1. EWPs Made From Virgin Wood or Pre-Consumer Wood Waste
CPSC staff reviewed the TERA Task 9, 11 and 14 Reports. CPSC staff
also examined TERA's source references to better understand the
reports' findings. CPSC's review of TERA's Task 14 Report showed that
there were few studies characterizing the content of EWPs, as
manufactured, in relation to lead and the ASTM F963 elements, and no
studies were found on the phthalates of interest. Where there were
studies, staff's review of the TERA report showed there was no evidence
that untreated and unfinished EWPs made from virgin wood or pre-
consumer wood waste, using generally used manufacturing practices and
materials, had content levels greater than the specified limits.
Staff finds that, based on the TERA reports, untreated and
unfinished EPWs (particleboard, hardwood plywood, and medium-density
fiberboard) made from virgin wood or pre-consumer wood waste, do not
contain lead, or any of the specified elements in ASTM F963 that exceed
the specified limits. In addition, with the exception of hardwood
plywood that contains PVAc adhesive formulations, discussed further in
this section, the specified EWPs do not contain any of the specified
phthalates in concentrations greater than 0.1 percent.
2. EWPs Made From Reclaimed or Post-Consumer Wood Waste
The TERA Task 14 Report highlighted the risk of introducing
materials contaminated with lead, the ASTM F963 elements, and the
specified phthalates when using reclaimed or post-consumer wood waste
to manufacture EWPs. Staff is aware that there is increasing interest
in using recycled materials, rather than landfilling. Environmentally
oriented initiatives encourage recycled wood content, especially in the
European Union (E.U.). The E.U. Waste Framework Directive requires
recycling or reuse of at least 70 percent of construction and
demolition waste in member states by 2020.\19\
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\19\ https://ec.europa.eu/environment/waste/construction_demolition.htm.
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Staff's review of TERA's reclaimed or post-consumer waste
assessment in EWPs indicates that, although most manufacturing in the
Americas currently does not use post-consumer wood waste as a
constituent part, EWPs with post-consumer wood content are not only
technologically feasible, but also are currently available. Although
the majority of the post-consumer wood waste used to manufacture EWPs
is ``clean,'' consisting of wood pallets, spools, or shipping crates,
reclaimed materials could be contaminated with paint, coatings, or
chemical treatments. There are some standards (e.g., European Panel
Federation, E.U. Community Ecolabel) for EWPs with content requirements
that roughly align with the ASTM F963 requirements; however, many are
voluntary and have no third party testing requirements.
Staff notes that manufacturers do have an incentive to avoid
contamination of EWPs because the addition of recycled materials could
be detrimental to manufacturing equipment or the finished product's
performance. Surface coatings, such as paint or stains, metals from
nails or fasteners, adhesive formulations, such as resins or glues, and
other non-wood content can potentially damage equipment, stop a
production line, or adversely impact the uniformity of the product.
However, staff is not aware of any current manufacturer processing
protocols that would keep unwanted contaminants out of EWP
manufacturing. Because of the contamination issues identified, the
staff does not have a high degree of assurance that EWPs made from
post-consumer wood waste are compliant with sections 101, 106, or 108
of the CPSIA at this time.
3. EWPs With Post-Manufacturing Treatments or Finishes
Staff's review of the Task 14 Report shows that most consumer
products made from EWPs will have some additional treatments or
finishes that are applied to the EWPs after their manufacture. TERA's
report identified that certain surface treatments (e.g., paints,
stains), metals, glues and adhesives, glass, paper, plastic, rubber and
chemical treatments may be added to EWPs. Metals and organic materials
may be present in paints, stains, varnishes, and polishes that are used
on wood products (e.g., furniture, window frames) and nails, screws,
and other metal hardware might be attached to the recycled and
recovered wood.
Staff's review shows that post-manufacturing treatments or finishes
made be applied to EWPs manufactured from virgin or pre-consumer wood
waste, as well as EWPs manufactured from post-consumer wood waste. Such
treatments or finishes may include paint or similar surface coating
materials, flame retardants, rot resistant finishes, wood glue, or
metal fasteners. The TERA report indicated that coatings, finishes, and
chemical treatments, such flame-retardant coatings or rot resistant
finishes, are a potential source of phthalates or the ASTM F963
elements. Staff's review of EWPs that have post-manufacturing
treatments or finishes shows that there is potential for lead, the ASTM
F963 elements, or the specified phthalates to be present in
concentrations greater than at the specified levels. Unless a post-
manufacture treatment or finish has been determined by the CPSC to be
compliant with sections 101, 106, or 108 of the CPSIA,\20\ staff does
not have a high degree of assurance that EWPs that have post-
manufacturing treatments or finishes are compliant with sections 101,
106, or 108 of the CPSIA at this time.
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\20\ See 16 CFR 1500.91; 16 CFR 1250.2; 16 CFR part 1308.
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4. Adhesive Formulations in EWPs
The Task 14 Report generally found that there was little evidence
to suggest that the ASTM F963 elements are likely to be present in any
of the commonly used adhesives in concentrations greater than the ASTM
solubility limits. Staff notes, that although one study suggested that
barium, when used as a catalyst in an adhesive, could result in an EWP
that exceeded the ASTM solubility level for barium, this method does
not appear to be used currently in EWP production.
Staff's review of the Task 11 Report indicates that phthalates
could be used in some adhesive formulations, including in PVAc
adhesives, such as wood or craft glues. In addition, the Task 14 Report
identified the adhesive formulations used in the manufacture of EWPs
and found that one, PVAc, could contain at least one of the specified
phthalates. TERA also reported that PVAc could be used in hardwood
plywood manufacturing. However, TERA was unable to identify whether the
specific PVAc adhesive formulations used currently in the manufacture
of hardwood plywood contained any of the specified phthalates in
concentrations greater than the specified limits.
CPSC staff research indicates that PVAc may be associated with the
manufacture of hardwood plywood, consistent with TERA's finding. One
manufacturer of EWP adhesive formulations provided information through
a contact at the USDA Forest Products Laboratory. The manufacturer
confirmed that, while current formulations no longer use phthalates,
PVAc adhesive formulations they manufacture contained phthalates in the
past. The manufacturer also stated that there is greater use of PVAc
adhesive formulations in hardwood plywood
[[Page 47652]]
than indicated in the TERA report, perhaps due to an increasing
interest in lowering formaldehyde emissions from EWPs. Because of the
lack of information regarding the use of PVAc adhesives containing the
specified phthalates in concentrations greater than those allowed,
staff does not have a high degree of assurance that EWPs that include
PVAc adhesive formulations in hardwood plywood are compliant with
sections 101, 106, or 108 of the CPSIA at this time.
D. Determinations for EWPs
1. Legal Requirements for a Determination
As discussed in section A.1. of the preamble, 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).
Children's products must comply with the lead limits in section 101 of
the CPSIA. 15 U.S.C. 1278a. Children's toys must comply with the
solubility limits for elements under the ASTM toy standard in section
106 of the CPSIA. 15 U.S.C. 2056b. Children's toys and child care
articles must comply with the phthalates prohibitions in section 108 of
the CPSIA. 15 U.S.C. 2057c. 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 children's products, children's toys,
and child care articles would not require third party testing.
To issue a determination that an EWP does not require third party
testing, the Commission must have sufficient evidence to conclude that
the product consistently complies with the CPSC requirements to which
the EWP is subject so that third party testing is unnecessary to
provide a high degree of assurance of compliance. Under 16 CFR part
1107 section 1107.2, ``a high degree of assurance'' is defined as ``an
evidence-based demonstration of consistent performance of a product
regarding compliance based on knowledge of a product and its
manufacture.''
For accessible component parts of children's products, children's
toys, and child care articles subject to sections 101, 106, and 108 of
the CPSIA, compliance to the specified content limits is always
required, irrespective of any testing exemptions. Thus, a manufacturer
or importer who certifies a children's product, toy or child care
article, must assure the product's compliance. The presence of lead,
the ASTM F963 elements, or the specified phthalates does not have to be
intended to require compliance. The presence of these chemicals,
whether for any functional purpose, as a trace material, or as a
contaminant, must be in concentrations less than the specified content
or solubility limits for the material to be compliant. Additionally,
the manufacturer or importer must have a high degree of assurance that
the product has not been adulterated or contaminated to an extent that
would render it noncompliant. For example, if a manufacturer or
importer is relying on a determination that an EWP does not contain
lead, ASTM F963 elements, or specified phthalates in concentrations
greater than the specified limits in a children's product, children's
toy, or child care article, the manufacturer must ensure that the EWP
is one on which a determination has been made.
Furthermore, under the proposed rule, any determinations that are
made on EWPs are limited to unfinished and untreated EWPs made from
virgin wood or pre-consumer wood waste. Children's products, children's
toys, and child care articles made from these EWPs may have other
materials that are applied to or added on to the EWP after it is
manufactured, such as treatments and finishes. Such component parts
fall outside of the scope of the proposed determinations and would be
subject to third party testing requirements, unless the component part
has a separate determination which does not require third-party testing
for certification purposes. Finally, even if a determination is in
effect and third party testing is not required, a certifier must still
issue a certificate.
The three engineered woods for which the determinations are
proposed are: Particleboard, hardwood plywood, and medium-density
fiberboard. Based on staff's review of the TERA reports as discussed in
section C. of the preamble, the Commission is proposing determinations
that there is a high degree of assurance that these three EWPs in an
untreated and unfinished state made from virgin or pre-consumer wood
waste will not contain lead, the ASTM F963 elements, or the specified
phthalates in excess of allowable levels. Specifically, the Commission
is proposing determinations that would find that particleboard and MDF
that is untreated and unfinished and made with virgin wood or pre-
consumer wood waste, would not contain lead, the ASTM F963 elements, or
the specified phthalates (DEHP, DBP, BBP, DINP, DIDP, or DnOP) in
concentrations greater than their specified limits.
In addition, with the exception of hardwood plywood that contains
PVAc adhesive formulations, untreated and unfinished hardwood plywood
made with virgin wood or pre-consumer wood waste would be determined
not to contain lead, the ASTM F963 elements, and the specified
phthalates in concentrations greater than their specified limits.
These determinations would mean that, for the specified EWPs, third
party testing is not required to assure compliance with sections 101,
106, and 108 of the CPSIA. The Commission proposes to make these
determinations to reduce the third party testing burden on children's
product certifiers while continuing to assure compliance.
2. 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. Section 14 of the CPSA,
which was amended by the CPSIA, requires third party testing for
children's products 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 propose a rule determining that
certain EWPs would not be determined to contain lead, the ASTM F963
elements, and the specified phthalates (DEHP, DBP, BBP, DINP, DIDP, or
DnOP) \21\ in concentrations greater than their specified limits, and
thus, are not required to be third party tested to assure compliance
with sections 101, 106, and 108 of the CPSIA.
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\21\ See supra note 13.
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The proposed determinations would relieve the three specified EWPs
from the third party testing requirement of section 14 of the CPSA for
purposes of supporting the required certification. However, the
proposed determinations would not be applicable to any other EWPs
beyond those listed in the proposed rule. Moreover, the proposed
determinations are not applicable to EWPs that are not made of virgin
wood or pre-consumer wood waste, or to
[[Page 47653]]
EWPs that have post-manufacture treatments or finishes. The proposed
determinations also are not applicable to hardwood plywood that contain
PVAc adhesive formulations. The proposed determinations would only
relieve the manufacturers' obligation to have the specified EWPs tested
by a CPSC accepted third party conformity assessment body. Children's
products, children's toys, and child care articles must still comply
with the substantive content limits in section 101, 106, and 108 of the
CPSIA regardless of any relief on third party testing requirements.
3. Description of the Proposed Rule
This proposed rule would create a new Part 1252 for ``Children's
Products, Children's toys, and Child Care Articles: Determinations
Regarding Lead, ASTM F963 Elements, and Phthalates for Engineered Wood
Products.'' The proposed rule would determine that the specified three
EWPs do not contain lead in concentrations exceeding 100 ppm, any of
the ASTM F963 elements in excess of specified concentrations, and any
of the statutorily prohibited phthalates (DEHP, DBP, BBP, DINP, DIDP,
DnOP) in concentrations greater than 0.1 percent. As discussed in
section A.4. of the preamble, the agency is currently involved in
rulemaking to determine whether to continue the interim prohibitions in
section 108 and whether to prohibit any other phthalates in children's
toys or child care articles. TERA's examination covered all phthalates
that are subject to the current permanent and interim prohibitions, as
well as the additional phthalates the Commission proposed restricting
in the Phthalates NPR. If the Commission issues a final rule in the
phthalates rulemaking before finalizing this determinations rulemaking,
the final determinations rule for EPWs would cover the same phthalates
restricted by the final phthalates rule.
Section 1252.1(a) of the proposed rule explains the statutorily-
created requirements that limit lead in children's products under the
CPSIA and the third party testing requirements for children's products.
Section 1252.1(b) of the proposed rule explains the statutorily-
created requirements for limiting the ASTM F963 elements in children's
toys under the CPSIA and the third party testing requirements for
children's toys.
Section 1252.1(c) of the proposed rule explains the statutorily-
created requirements limiting phthalates for children's toys and child
care articles under the CPSIA and the third party testing requirements
for children's toys and child care articles.
Section 1252.2 of the proposed rule would provide definitions that
apply to part 1252.
Section 1252.3(a) of the proposed rule would establish the
Commission's determinations that specified EWPs do not exceed the lead
content limits with a high degree of assurance as that term is defined
in 16 CFR part 1107.
Section 1252.3(b) of the proposed rule would establish the
Commission's determinations that specified EWPs do not exceed the
solubility limits for ASTM F963 elements with a high degree of
assurance as that term is defined in 16 CFR part 1107.
Section 1252.3(c) of the proposed rule would establish the
Commission's determinations that specified EWPs do not exceed the
phthalates content limits, with the exception of hardwood plywood
containing PVAc, with a high degree of assurance as that term is
defined in 16 CFR part 1107.
Section 1252.3(d) of the proposed rule states that accessible
component parts of children's products, children's toys, and child care
articles made with the specified EWPs, are not required to be third
party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part
1107.
Section 1252.3(e) of the proposed rule states that accessible
component parts of children's products, children's toys, and child care
articles that are not specifically listed in the determinations in
proposed Sec. 1252.3(a) through (c) are required to be third party
tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107.
4. Comments on the Proposed Rule
The Commission seeks comments on all aspects of the proposed rule.
In particular, comments of the following topics are welcome.
Are there any data or examples that indicate that the EWPs
identified in the proposed rule can and do contain lead, the ASTM F963
elements, or prohibited phthalates at levels that are not compliant?
Please provide data supporting your assertion.
The TERA Task 14 Report identified the use of some of the
ASTM F963 elements as catalysts in adhesive formulations used to
manufacture EWPs. Please provide any information that supports or
refutes the claim that these elements will not be present in
concentrations greater than their specified limits in EWPs.
CPSC staff has heard from a manufacturer of PVAc adhesive
formulations used in the manufacture of hardwood plywood that, although
phthalates are no longer used in domestic production, they were once
used. What phthalates were used in PVAc in the past? Could any of the
specified phthalates be used? Why or why not? Are any of the specified
phthalates used in domestic or international manufacturing of EWPs? Why
or why not?
How can one determine if a hardwood plywood sheet contains
a PVAc adhesive system? How can one determine whether a PVAc adhesive
system used in the manufacture of hardwood plywood contains a specified
phthalate in concentrations greater than the specified limits? Can this
type of information be found on labels, SDSs, company Web sites, or in
some other way?
Other than PVAc, are there additional adhesive
formulations used in the manufacture of EWPs that could contain the
specified phthalates in concentrations greater than those specified? If
yes, what phthalates are used and at what concentration?
Are there any post-consumer recycled EWPs that
consistently comply with the limits for lead, ASTM F963 elements, or
prohibited phthalates?
Please describe the methods used to determine whether
post-consumer recycled material is used in the manufacture of EWPs. How
can this type of information be found (on labels, SDSs, company Web
sites, or in some other way)?
In addition to particleboard, hardwood plywood, and
medium-density fiberboard, are there other EWPs widely used in
children's products, children's toys, and child care articles that have
not been identified in the proposed rule that do not, and will not,
contain lead, the ASTM F963 elements, or prohibited phthalates in
concentrations greater than the mandatory limits? Please provide
supporting data.
E. Effective Date
The Administrative Procedure Act (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 proposed rule would
provide relief from existing testing requirements under the CPSIA, the
Commission proposes a 30 day effective date for the final rule.
F. Regulatory Flexibility Act
1. Introduction
The Regulatory Flexibility Act (RFA) requires that agencies review
a proposed rule for the rule's potential economic impact on small
entities, including small businesses. Section 603 of the RFA generally
requires that agencies
[[Page 47654]]
prepare an initial regulatory flexibility analysis (IRFA) and make the
analysis available to the public for comment when the agency is
required to publish a notice of proposed rulemaking, unless the agency
certifies that the proposed rule will not have a significant economic
impact on a substantial number of small entities. The IRFA must
describe the impact of the proposed rule on small entities and identify
any alternatives which accomplish the statutory objectives and may
reduce the significant economic impact of the proposed rule on small
entities. We provide a summary of the IRFA.
2. Small Entities to Which the Proposed Rule Would Apply
The proposed rule would apply to small entities that manufacture or
import children's products, children's toys, and child care articles
that contain particleboard, hardwood plywood, or medium-density
fiberboard. The number of domestic manufacturers classified in the
North American Industrial Classification System (NAICS) categories that
could manufacture children's products, children's toys, or child care
articles that may contain accessible particleboard, hardwood plywood,
or medium-density fiberboard component parts and would be responsible
for the certification of these products may include 7,059 firms that
can be categorized as small.\22\ Of these, 3,705 have fewer than 5
employees. However, it is doubtful that all of the firms in some of
these categories produce children's products. Moreover, of those firms
that do produce children's products, we do not know how many of the
firms manufacture products with accessible particleboard, hardwood
plywood, or medium-density fiberboard component parts.
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\22\ The numbers of small firms for each NAICS code are from the
Census Bureau and generally based on the SBA criteria for small
firms.
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The number of domestic wholesalers by NAICS code that could
distribute children's products, children's toys, or child care articles
that may contain accessible particleboard, hardwood plywood, or medium-
density fiberboard component parts may include 26,113 firms that can be
categorized as small. Of these, 15,947 have less than 5 employees.
Wholesalers who obtain their products strictly from domestic
manufacturers or from other wholesalers would not be impacted by the
rule because the manufacturer or importer would be responsible for
certifying the products. Although importers are responsible for the
certification of the children's products that they import, they may
rely upon third party testing performed by their foreign suppliers for
purposes of certification. The number of small wholesalers that import
children's products, children's toys, or child care articles as opposed
to obtaining their product from domestic sources is not known. Also
unknown is the number of small importers that must obtain or pay for
the third party testing of their products.
The number of domestic retailers by NAICS code that could sell
children's products, children's toys, or child care articles that may
contain accessible particleboard, hardwood plywood, or medium-density
fiberboard component parts may include 49,358 firms that can be
categorized as small. Of these, 27,506 have less than 5 employees.
Although there are almost 50,000 retailers in the NAICS categories, the
only retailers that would be directly impacted by the proposed rule are
those that import children's products themselves. Retailers that obtain
all of their products from domestic manufacturers or wholesalers will
not be directly impacted by the rule because the manufacturers or
wholesalers would be responsible for certifying the products.
Although comprehensive estimates of the number of children's
products, children's toys, and child care articles that contain
component parts made from the specified engineered woods are not
available, there is evidence that these engineered woods are used in
children's furniture, sporting equipment, children's toys, and some
musical instruments. Based on the number of domestic toy manufacturers
that are classified as small businesses by the U.S. Bureau of the
Census and evidence that the specified engineered woods are used in
children's products, children's toys, and child care articles, the
Commission believes a substantial number of small entities would be
impacted by this regulation.
3. Reporting, Recordkeeping, and Other Compliance Requirements and
Impact on Small Businesses
The proposed rule would determine that there is a high degree of
assurance that the certain EWPs be determined not to contain lead, the
ASTM F963 elements, and the specified phthalates (DEHP, DBP, BBP, DINP,
DIDP, or DnOP) in concentrations greater than their specified limits.
Under this proposed determination, manufacturers, importers, and
private labelers of children's products, children's toys, and child
care articles that have accessible component parts that consist of
these engineered woods would not require third party testing for
certification that these components comply with the lead, ASTM F963
elements, or phthalate requirements.
The proposed rule would not impose any reporting, recordkeeping, or
other compliance requirements on small entities. In fact, because the
proposed rule would eliminate a testing requirement, there would be a
small reduction in some of the recordkeeping burden under 16 CFR parts
1107 and 1109 because manufacturers would no longer have to maintain
records of third party tests for the component parts manufactured from
these engineered woods for lead, the ASTM F963 elements, or the
specified phthalates.
The impact of the determinations on small businesses would be to
reduce the burden of third party testing for the content of lead, the
ASTM F963 elements, and the specified phthalates and would be expected
to be entirely beneficial. The cost of lead testing ranges from $50 to
more than $100 per component through Inductively Coupled Plasma testing
(ICP). If one uses X-ray fluorescence spectrometry (XRF), which is an
acceptable method for certification of third-party testing for lead
content, the costs can be greatly reduced to approximately $5 per
component part. If a component part made with one of the specified
engineered woods is painted, the component part would be exempt from
the third party testing requirement, but the paint would still require
lead testing.
Based on published invoices and price lists, the cost of a third
party test for the ASTM F963 elements ranges from around $60 in China,
up to around $190 in the United States using ICP. This cost can be
greatly reduced with the use of high definition X-ray fluorescence
spectrometry (HDXRF), which is an acceptable method for certification
of third-party testing for the presence of the ASTM F963 elements. The
cost can be reduced to about $40 per component. It should be noted that
lead is one of the ASTM F963 elements, so this testing would also cover
the cost of lead testing for component parts.
The cost of phthalate testing is relatively high: Between about
$125 and $350 per component part, depending upon where the testing is
conducted and any discounts that are applicable. Because one product
might have multiple component parts that require testing, the cost of
testing a single product for phthalates could exceed $1,000 in some
cases. Moreover, more than one sample might have to be tested to
provide a high degree of assurance of
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compliance with the requirements for testing. To the extent that small
businesses have lower production or sales volumes than larger
businesses, these determinations would be expected to have a
disproportionately beneficial impact on small businesses. This
beneficial impact is due to spreading the costs of the testing over
fewer units; and the benefit of the Commission making the
determinations would be greater on a per unit basis for small
businesses. Additionally, some testing laboratories may offer their
larger customers discounts that might not be available to small
businesses that need fewer third party tests. Making the determinations
for these engineered woods could potentially significantly benefit a
substantial number of firms.
On the other hand, the benefit of making the determinations could
be less than might be expected. For example, some firms might have been
able to substantially reduce their third party testing costs by using
component part testing as allowed under 16 CFR 1109, so the marginal
benefit that might be derived from making the determinations might be
low. Also, some firms have reduced their testing costs by using XRF or
HDXRF technology, which is less expensive than ICP, and would reduce
the marginal benefit of these determinations. The Commission seeks
public comments on the potential impact of the proposed rule on small
entities. Comments are especially welcome on the following topics:
The extent to which particleboard, hardwood plywood, and
medium-density fiberboard are used in children's products, children's
toys, and child care articles, especially those manufactured or
imported by small firms;
The potential reduction in third party testing costs that
might be provided by the Commission making the determinations,
including the extent to which component part testing is already being
used and the current cost of testing components made from these
engineered woods for compliance with the lead, ASTM F963 elements, and
phthalate requirements;
Any situations or conditions in the proposed rule that
would make it difficult to make use of the determinations to reduce
third party testing costs; and
Although the Commission expects that the impact of the
proposed rule will be entirely beneficial, any potential negative
impacts of the proposed rule.
4. Alternatives Considered To Reduce the Burden on Small Entities
Under section 603(c) of the RFA, an initial regulatory flexibility
analysis should ``contain a description of any significant alternatives
to the proposed rule which accomplish the stated objectives of the
applicable statutes and which minimize any significant impact of the
proposed rule on small entities.'' Because the proposed rule is
intended to reduce the cost of third party testing on small businesses
and will not impose any additional burden, the Commission did not
consider alternatives to the proposed rule that would reduce the burden
of this rule on small businesses.
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 1252
Business and industry, Consumer protection, Imports, Infants and
children, Product testing and certification, Toys.
For the reasons stated in the preamble, the Commission proposes to
amend title 16 of the CFR to add part 1252 to read as follows:
PART 1252--CHILDREN'S PRODUCTS, CHILDREN'S TOYS, AND CHILD CARE
ARTICLES: DETERMINATIONS REGARDING LEAD, ASTM F963 ELEMENTS, AND
PHTHALATES FOR ENGINEERED WOOD PRODUCTS
Sec.
1252.1 Children's products, children's toys, and child care articles
containing lead, ASTM F963 elements, and phthalates in engineered
wood products and testing requirements.
1252.2 Definitions.
1252.3 Determinations for engineered wood products.
Authority: Sec. 3, Pub. L. 110-314, 122 Stat. 3016; 15 U.S.C.
2063(d)(3)(B).
Sec. 1252.1 Children's products, children's toys, and child care
articles containing lead, ASTM F963 elements, and phthalates in
engineered wood products and testing requirements.
(a) Section 101(a) of the Consumer Product Safety Improvement Act
of 2008 (CPSIA) provides that any children's product, material, or
component part or a children's product must comply with a lead content
limit that does not exceed 100 parts per million. Materials used in
children's products subject to section 101 of the CPSIA must comply
with the third party testing requirements of section 14(a)(2) of the
Consumer Product Safety Act (CPSA), unless listed in 16 CFR 1500.91.
(b) Section 106 of the CPSIA made provisions of ASTM F963, Consumer
Product Safety Specifications for Toy Safety, 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 children's toys that can be sucked, mouthed,
or ingested, must comply with solubility limits that the toy standard
establishes for eight elements. Materials used in children's 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 CPSA, unless
listed in 16 CFR 1251.2.
(c) Section 108(a) of the CPSIA permanently prohibits any
children's toy or child care article that contains concentrations of
more than 0.1 percent of di-(2-ethylhexl) phthalate (DEHP), dibutyl
phthalate (DBP), or benzyl butyl phthalate (BBP). Section 108(b)(1) of
the CPSIA prohibits on an interim basis any children's toy that can be
placed in a child's mouth or child care article that contains
concentrations of more than 0.1 percent of diisononyl phthalate (DINP),
diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP). Materials
used in children's toys and child care articles subject to section
108(a) and (b)(1) of the CPSIA must comply with the third party testing
requirements of section 14(a)(2) of the CPSA, unless listed in 16 CFR
part 1308.
Sec. 1252.2 Definitions.
In addition to the definitions given in sections 101, 106, and 108
of the CPSIA, the following definitions apply for this part 1252.
(a) Post-consumer wood waste describes wood waste that is comprised
of materials that are recovered from their original use and
subsequently used in a new product. Examples of this type of waste
include recycled demolition wood, packaging materials such as pallets
and crates, used wood from landscape care (i.e., from urban and highway
trees, hedges, and gardens), discarded furniture, and waste wood from
industrial, construction, and commercial activities.
(b) Pre-consumer wood waste describes wood materials that have been
recycled from an industrial process
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before being made available for consumer use. Examples of this type of
waste include trimmings from engineered wood product (EWP) panel
manufacturing, sawdust from cutting logs, or remaining wood pieces from
sawing a log into framing lumber.
(c) Unfinished means an EWP that does not have any surface
treatments applied at manufacture, such as factory-applied coatings.
Examples of such treatments may include paint or similar surface
coating materials, wood glue, or metal fasteners, such as nails or
screws.
(d) Untreated means an EWP that does not have any additional
finishes applied at manufacture. Examples of such finishes may include
flame retardants or rot resistant finishes.
(e) Virgin wood describes wood logs, fibers, chips, or layers that
have not been recycled from a previous use.
Sec. 1252.3 Determinations for engineered wood products.
(a) The following engineered wood products do not exceed the lead
content limits with a high degree of assurance as that term is defined
in 16 CFR part 1107:
(i) Particleboard that is untreated and unfinished made from virgin
wood or pre-consumer wood waste;
(ii) Hardwood plywood that is untreated and unfinished made from
virgin wood or pre-consumer wood waste; and
(iii) Medium-density fiberboard that is untreated and unfinished
made from virgin wood or pre-consumer wood waste.
(b) The following engineered wood products do not exceed the ASTM
F963 elements solubility limits set forth in 16 CFR part 1250 with a
high degree of assurance as that term is defined in 16 CFR part 1107:
(i) Particleboard that is untreated and unfinished made from virgin
wood or pre-consumer wood waste;
(ii) Hardwood plywood that is untreated and unfinished made from
virgin wood or pre-consumer wood waste; and
(iii) Medium-density fiberboard that is untreated and unfinished
made from virgin wood or pre-consumer wood waste.
(c) The following engineered wood products do not exceed the
phthalates content limits with a high degree of assurance as that term
is defined in 16 CFR part 1107:
(i) Particleboard that is untreated and unfinished made from virgin
wood or pre-consumer wood waste;
(ii) Hardwood plywood that is untreated and unfinished made from
virgin wood or pre-consumer wood waste and does not contain PVAc
adhesive formulations; and
(iii) Medium-density fiberboard that is untreated and unfinished
made from virgin wood or pre-consumer wood waste.
(d) Accessible component parts of children's products, children's
toys, and child care articles made with EWPs, listed in paragraphs (a)
through (c) of this section are not required to be third party tested
pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107.
(e) Accessible component parts of children's products, children's
toys, and child care articles made with engineered wood products not
listed in paragraphs (a)-(c) of this section are required to be third
party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part
1107.
Alberta E. Mills,
Acting Secretary, Consumer Product Safety Commission.
[FR Doc. 2017-21980 Filed 10-12-17; 8:45 am]
BILLING CODE 6355-01-P