Children's Toys and Child Care Articles: Determinations Regarding ASTM F963 Elements and Phthalates for Unfinished Manufactured Fibers

 
CONTENT
Federal Register, Volume 84 Issue 196 (Wednesday, October 9, 2019)
[Federal Register Volume 84, Number 196 (Wednesday, October 9, 2019)]
[Proposed Rules]
[Pages 54055-54062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21517]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1253
[Docket No. CPSC-2019-0023]
Children's Toys and Child Care Articles: Determinations Regarding
ASTM F963 Elements and Phthalates for Unfinished Manufactured Fibers
AGENCY: U.S. Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Consumer Product Safety Commission (CPSC) is proposing a
rule to determine that certain unfinished manufactured fibers would not
contain the ASTM F963 elements or specified phthalates that exceed the
limits set forth under the CPSC's statutes and regulations for
children's toys and child care articles. Based on these proposed
determinations, the specified unfinished manufactured fibers would not
be required to have third party testing for compliance with the
requirements of the ASTM F963 elements or phthalates for children's
toys and child care articles.
DATES: Submit comments by December 23, 2019.
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2019-
0023 by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: www.regulations.gov. Follow the instructions for
submitting comments. The CPSC does not accept comments submitted by
electronic mail (email), except through www.regulations.gov. The CPSC
encourages you to submit electronic comments by using the Federal
eRulemaking Portal, as described above.
    Written Submissions: Submit written submissions by mail/hand
delivery/courier to: Division of the Secretariat, Consumer Product
Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD
20814; telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name
and docket number for this notice. All
[[Page 54056]]
comments received may be posted without change, including any personal
identifiers, contact information, or other personal information
provided, to: www.regulations.gov. Do not submit confidential business
information, trade secret information, or other sensitive or protected
information that you do not want to be available to the public. If
furnished at all, such information should be submitted in writing.
    Docket: For access to the docket to read background documents or
comments received, go to: www.regulations.gov, and insert the docket
number CPSC-2019-0023, into the ``Search'' box, and follow the prompts.
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: [email protected].
SUPPLEMENTARY INFORMATION:
A. Background
1. Third Party Testing and Burden Reduction
    Section 14(a) of the Consumer Product Safety Act, (CPSA), as
amended by the Consumer Product Safety Improvement Act of 2008 (CPSIA),
requires that manufacturers of products subject to a consumer product
safety rule or similar rule, ban, standard, or regulation enforced by
the CPSC, must certify that the product complies with all applicable
CPSC-enforced requirements. 15 U.S.C. 2063(a). For children's products,
certification must be based on testing conducted by a CPSC-accepted
third party conformity assessment body. Id. Public Law 112-28 (August
12, 2011) directed the CPSC to seek comment on ``opportunities to
reduce the cost of third party testing requirements consistent with
assuring compliance with any applicable consumer product safety rule,
ban, standard, or regulation.'' Public Law 112-28 also authorized the
Commission to issue new or revised third party testing regulations if
the Commission determines ``that such regulations will reduce third
party testing costs consistent with assuring compliance with the
applicable consumer product safety rules, bans, standards, and
regulations.'' Id. 2063(d)(3)(B).
    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 toys and child care articles manufactured
with seven manufactured fibers: polyester (polyethylene terephthalate,
PET), nylon, polyurethane (spandex), viscose rayon, natural rubber
latex, acrylic, and modacrylic, would comply with CPSC's requirements
for 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. 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.\2\ 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.
    \2\ The Commission is not proposing to incorporate ASTM F963 by
reference into part 1253.
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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 \3\ 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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    \3\ 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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                                                              Solubility
                          Elements                              limit,
                                                               (ppm) 4
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Antimony (Sb)..............................................           60
Arsenic (As)...............................................           25
Barium (Ba)................................................         1000
Cadmium (Cd)...............................................           75
Chromium (Cr)..............................................           60
Lead (Pb)..................................................           90
Mercury (Hg)...............................................           60
Selenium (Se)..............................................          500
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    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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    \4\ 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 party 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. 16 CFR part 1251. The
Commission also has determined that untreated and unfinished engineered
wood products would not require third party testing for the ASTM
elements or specified phthalates (discussed below) for children's
products, children's toys, and child care products. 16 CFR part 1252.
3. 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 phthalate
(BBP). 15 U.S.C. 2057c(a).
    The CPSIA required the Commission to appoint a Chronic Hazard
Advisory Panel (CHAP) to ``study the effects on
[[Page 54057]]
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. On October 27, 2017, the
Commission published a final rule in the Federal Register,
``Prohibition of Children's Toys and Child Care Articles Containing
Specified Phthalates,'' 82 FR 49938, prohibiting children's toys and
child care articles containing concentrations greater than 0.1 percent
of: di-(2-ethylhexyl) phthalate (DEHP); dibutyl phthalate (DBP); benzyl
butyl phthalate (BBP); diisononyl phthalate (DINP); diisobutyl
phthalate (DIBP); di-n-pentyl phthalate (DPENP); di-n-hexyl phthalate
(DHEXP); or dicyclohexyl phthalate (DCHP). These restrictions apply to
any plasticized component part of a children's toy or child care
article or any other component part of a children's toy or child care
article that is made of other materials that may contain phthalates.
The phthalates prohibitions are set forth in 16 CFR part 1307.
    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.
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.
B. Contractor's Research
    The CPSC contracted with the Toxicology Excellence for Risk
Assessment (TERA, or the contractor) to conduct literature reviews on
the production of certain undyed manufactured fibers and to evaluate
whether the specified manufactured fibers potentially contain (1) any
of the specified chemical elements that are included in the toy
standard in concentrations \5\ exceeding specified limits, or (2) any
of 10 specified phthalates in concentrations greater than 0.1 percent
(1000 ppm). TERA researched the following manufactured fibers:
polyester (polyethylene terephthalate, PET), nylon, polyurethane
(spandex), viscose rayon, natural rubber latex, acrylic, and
modacrylic. Staff reviewed the information provided in the TERA report,
Exposure Assessment: Potential for the Presence of Phthalates and Other
Specified Elements in Undyed Manufactured Fibers and their Colorants
(the report, Task 17).\6\ TERA's Task 17 report formed the basis for
the proposed unfinished manufactured fiber determinations. For more
detailed information on the Task 17 report and staff analysis please
see the staff briefing package. https://www.cpsc.gov/s3fs-public/Draft%20NPR-%20Children%27s%20Toys%20and%20Child%20Care%20Articles-%20Determinations%20Regar....pdf?IB4eKjJ_meZH1vdT5uQeojG8FfYGeqD9.
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    \5\ Although the ASTM F963-17 standard for chemical elements is
a solubility requirement, TERA researched total content, in part
because of the expected availability of content data versus
solubility data and because content is a conservative stand-in for
chemical solubility (i.e., the content of a chemical is the same
value as one hundred percent solubility of the chemical from
solubility testing).
    \6\ Task Order 17, Contract Number CPSC-D-12-0001. Available at:
https://www.cpsc.gov/s3fs-public/TERA%20Task17%20Report%20Phthalates%20and%20ASTM%20Elements%20in%20Manufactured%20Fibers.pdf.
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    All of the fibers covered in the Task 17 report are manufactured
and do not naturally occur in a fiber state. Although their raw
starting materials may be different, these fibers are generally
extruded into a fiber form. In many cases, additional chemicals may be
added before the extrusion process so that the chemicals are embedded
in the fiber structure. To better understand where the specified
phthalates or ASTM elements may be present, TERA documented the fiber
chemical characteristics, manufacturing processes, typical colorants,
and any other relevant information found through their search strategy.
C. CPSC Staff Analysis of TERA Task 17 Report
    CPSC staff reviewed the TERA Task 17 Report. CPSC staff also
examined TERA's source references to better understand the report's
findings. The Task 17 Report focused on the possibility of the ASTM
F963 elements and specified phthalates being present in seven
manufactured fiber types.
Unfinished Fibers
    The TERA report found one significant use of an ASTM element in
unfinished manufactured fibers: antimony in the production of polyester
(PET) fibers at concentrations of about 150-300 ppm, amounts that would
exceed the solubility limit specified in ASTM F963. Staff does not have
information identifying the amount of the antimony that is soluble when
tested according to ASTM F963. PET fiber is widely used in consumer
textile products, including children's toys. The contractor report did
not identify any other instances of the use of ASTM elements or
phthalates in the routine manufacturing processes for the specified
unfinished fibers.
    Compliance to the ASTM F963 standard can be demonstrated by
measuring the chemical content of a material--if the total content for
a specific element does not exceed the solubility limit, then it must
be the case that the solubility requirement is met. Because information
about solubility or migration of chemicals from products or materials
is rarely available in the scientific literature or other data sources,
staff relies on information about chemical content to understand
possible uses and presence of chemicals in products. If sufficient
solubility testing data were available, especially if data show low
levels of migration, such data may help inform decisions about testing
requirements under the ASTM F963 standard.
    In addition to intentional use of the specified chemicals, staff
considered whether contaminants or impurities may be present in
unfinished fibers, yarns, or fabrics. In the review of the contractor
report, the reports referenced by the contractor, and other reference
materials, staff has not found any information or data that suggest
contaminants would be present in fibers at significant levels. Reported
contaminant levels, such as for arsenic, chromium, mercury, or cadmium,
are no higher than a few parts per million. Staff believes that
contaminants or impurities are unintentional (i.e., not added by the
manufacturer intentionally), and largely represent the ubiquity of some
substances in the environment at trace levels or general industrial
practices and conditions. Given the available data and staff's
understanding of the raw materials and manufacturing practices for the
fibers currently under consideration, staff concludes that any
impurities will be at levels well below the relevant limits for this
proceeding.
Dyed or Finished Fibers (or Fibers With Chemical Additives Pre-Fiber
Formation)
    Colorants, such as dyes, often contain metals in their structure.
The contractor report cited the use of mercury, arsenic, barium, or
chromium in dyes or dye auxiliaries. For example, chrome dyes are a
type of acid dye that can be used on nylon fibers and contains chromium
to form a complex between the dye and the fiber. Because the use of
these metals is not necessarily limited to a specific dye class or
fiber type, staff cannot rule out the use of these metals at
concentrations greater than those
[[Page 54058]]
specified in ASTM F963 without more information. Furthermore, the
contractor report cited the potential use of some of the specified
phthalates as dye auxiliaries or carriers for pigments. Although some
of the findings may have been with products not necessarily within the
scope of the subject rules, the mechanism by which colorants are
applied to fibers could be extended to those products.
    Finishes may also be added at the fiber (yarn or fabric) stage to
impart desirable characteristics. The contractor report highlighted the
use of antimony compounds as flame retardants. Other chemicals of
interest may be used in finished fiber (yarn or fabric); however, those
finishes were not within the scope of the contractor report, and more
information is necessary to consider whether determinations for
finished fiber (yarn or fabric) are appropriate. Staff notes that in
the case of the ASTM elements (excluding lead, which has separate
specific restrictions under the CPSIA), the restriction in the ASTM
F963 standard is based on solubility; i.e., migration of the elements
from the product or material.
Recycled Content
    TERA did not examine the potential use of recycled materials in the
subject manufactured fibers. Staff is aware that recycled content is
present in some textile fibers; however, staff does not know the extent
to which recycled content can be expected in products within the scope
of the ASTM F963 elements or phthalates requirements. Due to findings
in the contractor report on colorants and finishes in manufactured
fibers, staff does not recommend determinations for fibers with
recycled content unless such content was from unfinished recycled
materials.
D. Determinations for Unfinished Manufactured Fibers
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 toys must comply with the limits on the ASTM F963 elements
incorporated in 16 CFR part 1250. Children's toys and child care
articles must comply with the phthalates prohibitions in section 108 of
the CPSIA and 16 CFR part 1307. 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
toys and child care articles would not require third party testing.
    To issue a determination that a manufactured fiber 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 manufactured fiber 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 toys and child care
articles subject to sections 106 and 108 of the CPSIA and 16 CFR part
1307, compliance to the specified content limits is always required,
irrespective of any testing exemptions. Thus, a manufacturer or
importer who certifies a children's toy or child care article, must
assure the product's compliance. The presence of 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 a manufactured fiber does not contain the ASTM
F963 elements or specified phthalates in concentrations greater than
the specified limits in a children's toy or child care article, the
manufacturer must ensure that the manufactured fiber is one on which a
determination has been made.
    Furthermore, under the proposed rule, any determinations that are
made on manufactured fibers are limited to unfinished manufactured
fibers. Children's toys and child care articles made from these
manufactured fibers may have other materials that are applied to or
added on to the manufactured fiber after it is manufactured, such as
colorants and flame retardants. 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 that 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 six unfinished manufactured fibers for which determinations are
proposed for the ASTM F963 elements are: Nylon, polyurethane (spandex),
viscose rayon, acrylic, and modacrylic, and natural rubber latex. Based
on staff's review of the TERA report as discussed in section C. of the
preamble, the Commission is proposing determinations that there is a
high degree of assurance that these unfinished manufactured fibers will
not contain the ASTM F963 elements in concentrations greater than their
specified limits. We note that based on staff's review of the Task 17
report we are not proposing a determination that polyester (PET) fiber
does not contain any of the ASTM F963 elements in concentrations
greater than their specified solubility limits due to findings in the
contractor report regarding the use of antimony compounds in polyester
manufacturing.
    The Commission is also proposing determinations for seven
unfinished manufactured fibers for the specified phthalates
prohibitions: Polyester (PET), nylon, polyurethane (spandex), viscose
rayon, acrylic, and modacrylic, and natural rubber latex. Based on
staff's review of the TERA report as discussed in section C. of the
preamble, the Commission is proposing determinations that there is a
high degree of assurance that these unfinished manufactured fibers will
not contain the prohibited phthalates in concentrations greater than
their specified limits.
    These determinations would mean that, for the specified unfinished
manufactured fibers, third party testing is not required to assure
compliance with sections 106 and 108 of the CPSIA and 16 CFR part 1307.
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
[[Page 54059]]
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 unfinished manufactured fibers
do not contain the ASTM F963 elements and the specified prohibited
phthalates in concentrations greater than their specified limits, and
thus, are not required to be third party tested to assure compliance
with sections106 and 108 of the CPSIA and 16 CFR part 1307.
    The proposed determinations would relieve manufacturers using the
specified unfinished manufactured fibers from the third party testing
requirements of section 14 of the CPSA for purposes of supporting the
required certification. However, the proposed determinations would not
be applicable to any other manufactured fibers beyond those listed in
the proposed rule. The proposed determinations would only relieve the
manufacturers' obligation to have the specified unfinished manufactured
fibers tested by a CPSC-accepted third party conformity assessment
body. Children's toys and child care articles must still comply with
the substantive content limits in sections 106 and 108 of the CPSIA and
16 CFR part 1307 regardless of any relief on third party testing
requirements.
3. Description of the Proposed Rule
    This proposed rule would create a new Part 1253 for ``Children's
toys and Child Care Articles: Determinations Regarding the ASTM F963
Elements and Phthalates for Unfinished Manufactured Fibers.'' The
proposed rule would determine that the specified unfinished
manufactured fibers do not contain any of the ASTM F963 elements in
excess of specified concentrations, and any of the phthalates (DEHP,
DBP, BBP, DINP, DIBP, DPENP, DHEXP, and DCHP) prohibited by statute or
regulation in concentrations greater than 0.1 percent.
    Section 1253.1(a) 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 1253.1(b) of the proposed rule explains the statutory and
regulatory 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 1253.2(a) of the proposed rule would provide a definition
of the term unfinished manufactured fiber that would apply to part
1253.
    Section 1253.2(b) of the proposed rule would establish the
Commission's determinations that specified unfinished manufactured
fibers 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 1253.2(c) of the proposed rule would establish the
Commission's determinations that specified unfinished manufactured
fibers do not exceed the phthalates content limits with a high degree
of assurance as that term is defined in 16 CFR part 1107.
    Section 1253.2(d) of the proposed rule states that accessible
component parts of children's toys and child care articles made with
the specified unfinished manufactured fibers specifically listed in the
determinations in proposed Sec.  1253.3(b) and (c) are not required to
be third party tested pursuant to section 14(a)(2) of the CPSA and 16
CFR part 1107.
    Section 1253.2(e) of the proposed rule states that accessible
component parts of children's toys and child care articles that are not
specifically listed in the determinations in proposed Sec.  1253.3(b)
and (c) are required to be third party tested pursuant to section
14(a)(2) of the CPSA and 16 CFR part 1107.
4. Requested Comments on the Proposed Rule
    The Commission seeks comments on all aspects of the proposed rule.
In particular, comments on the following topics are welcome.
     Are there any data or examples that indicate that the
manufactured fibers identified in the proposed rule can and do contain
the ASTM F963 elements (besides the identified use of antimony in PET)
or prohibited phthalates at levels that are not compliant in an
unfinished state? Please provide data supporting your assertion.
     The TERA Task 17 Report identified the use of antimony, an
ASTM F963 element, as a catalyst used to manufacture PET. Although TERA
looked for the presence and total concentration of antimony, the ASTM
F963-17 requirement is for the concentration that migrates out of the
subject material. Please provide any information that supports or
refutes the claim that antimony will not be present in concentrations
greater than the specified limits in PET fiber in an unfinished state
without colorants. Please provide any information that antimony will
not migrate out of polyester in concentrations greater than the
specified limits in PET fiber in an unfinished state with no colorants.
     Are there any data or examples that the colorants or other
finishes used for the manufactured fibers identified in the proposed
rule never contain the ASTM F963 elements or prohibited phthalates at
levels that are not compliant? Please provide data supporting your
assertion. These data may be by type of dye, a specific dye, by fiber
type, or some other relevant grouping.
     Are there any data or examples that the use of recycled
content in the manufactured fibers identified in the proposed rule
never contain the ASTM F963 elements or prohibited phthalates at levels
that are not compliant? Please provide data supporting your assertion.
These data may be by fiber type, product type, or some other relevant
grouping.
     In addition to the manufactured fibers within scope of
this study, are there other manufactured fibers widely used in
children's toys and childcare articles that have not been identified in
the proposed rule that do not, and will not contain the ASTM F963
elements or prohibited phthalates? Please provide supporting data to
show that these manufactured fibers do not and will not contain the
ASTM F963 elements or prohibited phthalates in concentrations above the
mandatory limits?
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 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
[[Page 54060]]
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 toys and child care articles that contain the
specified manufactured fibers. The chemical elements in the ASTM F963
toy safety standard and the specified phthalates apply to the
particular children's products specified in the respective
requirements. The phthalates prohibitions apply to children's toys and
child care articles. Regarding the specified manufactured fibers (or
yarns or fabrics) in the children's toy category, products potentially
affected by a Commission determination about phthalate content may
include coverings or fill of stuffed, plush, or other soft toys, doll
clothes, puzzle mats or other play mats, and other similar toys. Under
the child care article category, products potentially affected by a
Commission determination about phthalate content may include sleepwear,
bibs, and other products that facilitate sleeping or feeding. The
chemical requirements in the ASTM F963 toy safety standard cover
accessible substrates of toys that can be sucked, mouthed, or ingested.
The specified manufactured fibers (or yarns or fabrics) could be used
in coverings or fill of stuffed, plush, or other soft toys, doll
clothes, puzzle mats or other play mats, and other similar toys.
    The rule would apply to small entities that manufacture or import
children's toys or child care articles that contain accessible
polyester (PET), nylon, natural latex rubber, polyurethane (spandex),
rayon, acrylic, and modacrylic component parts. Toy manufacturers are
classified in North American Industry Classification System (NAICS)
category 339930 (Doll, Toy, and Game Manufacturing). According to the
U.S. Bureau of the Census, in 2015 there were 566 toy manufacturers in
the United States, of which 562 had fewer than 500 employees and would
be considered small entities according to the SBA criteria.\7\ Of the
small manufacturers, 347 had fewer than five employees.
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    \7\ U.S. Bureau of the Census, ``Number of Firms, Number of
Establishments, Employment, and Annual Payroll by Enterprise
Employment Size for the United States, All Industries: 2015,''
County Business Patterns. Available at: https://www2.census.gov/programs-surveys/susb/tables/2015/us_6digitnaics_2015.xlsx.
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    Toy importers may be either wholesale merchants or retailers. The
proposed rule would not apply to toy wholesalers or retailers if they
obtain their merchandise from domestic manufacturers or importers and
do not import toys or child care articles themselves. Toy wholesalers
are classified in NAICS category 423920 (Toy and Hobby Goods and
Supplies Merchant Wholesalers). According to the U.S. Bureau of the
Census, there were 2,009 firms in this category in 2015. Of these,
1,937 had fewer than 100 employees and would be considered small
businesses, according to SBA criteria. Toy retailers are classified in
NAICS category 451120 (Hobby, Toy, and Game Stores). There could be
about 4,632 toy retailers that would meet the SBA criteria to be
considered a small entity.\8\ Although importers are responsible for
certifying the children's products that they import, they may rely upon
third party testing performed by their foreign suppliers for purposes
of certification. We do not know the number of small toy wholesalers or
retailers that import toys, as opposed to obtaining their product from
domestic sources. We also do not know the number of small importers
that must obtain or pay for the third party testing of their products.
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    \8\ The SBA considers a toy retailer (NAICS 451120) to be a
small entity if its annual sales are less than $27.5 million.
According to the U.S. Bureau of the Census, in 2012, the average
receipts for toy manufacturers with more than 500 employees was
almost $900 million. The average receipts for the next largest
category for which summary data were published, toy retailers with
at least 100 but fewer than 500 employees, was about $10 million.
There were 4,647 firms in this NAICS category, of which 4,632 had
fewer than 500 employees. (U.S. Census Bureau, Number of Firms,
Number of Establishments, Employment, Annual Payroll, and Estimated
Receipts by Enterprise Employment Size for the United States, All
Industries: 2012.)
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    The phthalates regulation also applies to manufacturers and
importers of child care articles. Child care articles include many
types of products for which the CPSC has recently promulgated or
proposed new or amended mandatory safety standards. Under the child
care article category, products potentially affected by a Commission
determination about phthalate content of unfinished manufactured fibers
may include bedside sleepers, sleepwear, bibs, and other products that
facilitate sleep or feeding. Several types of these child care products
likely use the types of manufactured fibers that are addressed by the
proposed rule. In its recent market research, CPSC staff identified 364
suppliers of these products that would be considered small according to
criteria established by the SBA.\9\ Additionally, there could be other
child care articles, not listed above, for which CPSC has not yet
developed a mandatory or proposed standard, but which nevertheless are
covered by the phthalate requirements.
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    \9\ Krishnan, Charu S., Memorandum: Determinations that Certain
Plastics Will Not Contain Specified Phthalates: Regulatory
Flexibility Analysis, Directorate for Economic Analysis, CPSC. June
26, 2017.
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    Although the number of small businesses that supply children's toys
or child care articles to the U.S. market might be close to 10,000, we
do not know the number that actually supply products with the
unfinished manufactured fibers in accessible component parts. We also
do not know the number of children's toys and child care articles that
contain these fibers. Nevertheless, based on the number of domestic toy
manufacturers that are classified as small businesses (according to SBA
size standards and data provided by the U.S. Bureau of the Census) and
evidence that the specified fibers could be used extensively in toys
and child care articles, we believe a substantial number of small
entities would be positively impacted by the proposed rule.
3. Reporting, Recordkeeping, and Other Compliance Requirements and
Impact on Small Businesses
    The proposed rule would not impose any reporting, recordkeeping, or
other compliance requirements on small entities. In fact, the proposed
rule would eliminate a requirement that third party testing be done,
resulting in 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 the specified unfinished manufactured fibers.
    The impact of the determinations on small businesses would be to
reduce the burden of third party testing for the ASTM F963 elements and
the specified phthalates, and would be expected to be entirely
beneficial. 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 Inductively Coupled
[[Page 54061]]
Plasma (ICP) testing. 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 elements. The cost can be reduced to about $40 per
component.
    The cost of phthalate testing is relatively high: Between about
$125 and $350 per component, depending upon where the testing is
conducted and any discounts that are applicable. Because one product
might have multiple components that require testing, the cost of
testing a single product for phthalates could exceed $1,000.
    Moreover, more than one sample might have to be tested to provide a
high degree of assurance of 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 manufactured fibers could significantly benefit a substantial
number of firms.
    However, it is possible that the benefit of making the
determinations could be less than staff expects. Although the
manufactured fibers are widely used, the determinations are limited to
unfinished fibers, which might be less widely used. Additionally, some
firms might have been able to substantially reduce their third party
testing costs by using component part testing as allowed by 16 CFR
1109, so the marginal benefit to manufacturers 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. Finally, some firms, particularly importers, might not
know the specific fibers used in the products they import or whether
fibers are unfinished and might opt to conduct the testing anyway to
ensure that the products do not violate the requirements.
    In summary, although there are a substantial number of small
entities that manufacture or import children's toys and childcare
articles in which manufactured fibers could be used, we do not have
data on the number or the extent to which unfinished manufactured
fibers are used in these products. Therefore, we cannot determine
whether the reduced burden would be significant for a substantial
number of the small entities. We welcome 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 the specified unfinished manufactured
fibers are used in 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
unfinished manufactured fibers for compliance with the ASTM elements
and phthalate requirements;
     Any situations or conditions in the proposed rule that
would make it difficult to use the determinations to reduce third party
testing costs; and
     Although the CPSC staff 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 1253
    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 1253 to read as follows:
PART 1253--CHILDREN'S TOYS AND CHILD CARE ARTICLES: DETERMINATIONS
REGARDING THE ASTM F963 ELEMENTS AND PHTHALATES FOR UNFINISHED
MANUFACTURED FIBERS
Sec.
1253.1 Children's toys and child care articles containing the ASTM
F963 elements and phthalates in manufactured fibers and testing
requirements.
1253.2 Determinations for unfinished manufactured fibers.
    Authority:  Sec. 3, Pub. L. 110-314, 122 Stat. 3016; 15 U.S.C.
2063(d)(3)(B).
Sec.  1253.1  Children's toys and child care articles containing the
ASTM F963 elements and phthalates in manufactured fibers and testing
requirements.
    (a) Section 106 of the CPSIA made the provisions of ASTM F963,
Consumer Product Safety Specifications for Toy Safety, a mandatory
consumer product safety standard. 16 CFR part 1250 codified these
provisions by incorporating by reference ASTM F963, see 16 CFR1250.1.
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 Sec.  1253.2.
    (b) Section 108(a) of the Consumer Product Safety Improvement Act
of 2008 (CPSIA) permanently prohibits 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 benzyl butyl
phthalate (BBP). In accordance with section 108(b)(3) of the CPSIA, 16
CFR part 1307 prohibits any children's toy or child care article that
contains concentrations of more than 0.1 percent of diisononyl
phthalate
[[Page 54062]]
(DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-
n-hexyl phthalate (DHEXP), or dicyclohexyl phthalate (DCHP). Materials
used in children's toys and child care articles subject to section
108(a) of the CPSIA and 16 CFR part 1307 must comply with the third
party testing requirements of section 14(a)(2) of the Consumer Product
Safety Act (CPSA), unless listed in Sec.  1253.2.
Sec.  1253.2  Determinations for unfinished manufactured fibers.
    (a) The following definition for an unfinished manufactured fiber
applies for this part 1253. An unfinished manufactured fiber is one
that has no chemical additives beyond those required to manufacture the
fiber. For unfinished manufactured fibers as defined in this rule, the
unfinished manufactured fiber is free of any chemical additives added
to impart color or some desirable performance property, such as flame
retardancy.
    (b) The following unfinished manufactured fibers 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:
    (1) Nylon;
    (2) Polyurethane (Spandex);
    (3) Viscose Rayon;
    (4) Acrylic and Modacrylic; and
    (5) Natural Rubber Latex.
    (c) The following unfinished manufactured fibers do not exceed the
phthalates content limits set forth in 16 CFR part 1307 with a high
degree of assurance as that term is defined in 16 CFR part 1107:
    (1) Polyester (polyethylene terephthalate, PET);
    (2) Nylon;
    (3) Polyurethane (Spandex);
    (4) Viscose Rayon;
    (5) Acrylic and Modacrylic; and
    (6) Natural Rubber Latex.
    (d) Accessible component parts of children's toys and child care
articles made with the unfinished manufactured fibers, listed in
paragraphs (b) and (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 toys and child care
articles made with manufactured fibers not listed in paragraphs (b) and
(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,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2019-21517 Filed 10-8-19; 8:45 am]
 BILLING CODE 6355-01-P